d, intake of protein from     vegetable sources such as legumes and pulses should be increased. However, little is known     about the effect of protein from (Nordic grown) beans and peas on body weight and appetite     regulation.      The objective of this study is to examine if protein from vegetable sources (beans and peas)     is comparable to protein from animal sources regarding acute meal-induced satiety.   "
148120|NCT01345474|"     This prospective study is a randomized, double-blind, placebo-controlled Phase 3 clinical     trial of oral D-methionine (D-met) to reduce noise-induced hearing loss (NIHL) and tinnitus.     The goal of the study is to develop a safe, oral pharmacological agent to augment physical     hearing protectors for noise exposures that exceed the protective capabilities of ear plugs     and/or muffs. The study population is a cohort of Drill Sergeant (DS) instructor trainees     during and 22 days after their 11 day weapons training. The primary objective of this study     is to determine the efficacy of D-met in preventing NIHL or reducing tinnitus secondary to a     minimum of 500 rounds of M-16 weapons training occurring over an 11 day period.   "
148133|NCT01345305|"     This is a study of 40 individuals with Sturge-Weber Syndrome (SWS) brain and/or eye     involvement. It will examine the test-retest reliability of the following clinical tests:        1. Quantitative EEG        2. Transcranial Doppler        3. Medical Rehabilitation Scales        4. Optical Coherence Tomography   "
148147|NCT01345123|"     The purpose of this study is to compare condition oriented whole person Health Coaching along     with the provision of decision aids to decision aids without condition oriented Health     Coaching to neither condition oriented health coaching nor decision aids on medical cost,     preference sensitive surgeries and measures of subject knowledge, decision process and     decision quality.   "
148163|NCT01344915|"     Knee immobilization in near extension has been proposed as a nonoperative treatment for     primary traumatic patellar dislocation, although there exist no prospective studies regarding     the method of immobilization. The objective of this prospective randomized study was to     compare the clinical outcome after nonoperative treatment with restricted vs. free range of     motion (ROM) for primary traumatic patellar dislocation.   "
148121|NCT01345461|"     As the critical care practice has improved over the last decades more patients are recovering     from intensive care therapy. However, muscle atrophy and neuromuscular dysfunction are     commonly observed sequelae after critical illness and are thought to play important roles in     the development of intensive care unit acquired weakness (ICUAW). As a consequence, these     entities may contribute to the impaired physical function and prolonged convalescence     reported by ICU patients up to twelve months after discharge. Thus, strategies to counteract     muscle atrophy and neuromuscular dysfunction acquired during the ICU stay may therefore     potentially improve physical outcome and reduce the overall burden of critical illness.     Limited information is available on muscle function in ICU patients and to our knowledge no     muscle stimulation methods are currently available for evaluating muscle fatigue in large,     proximal muscles groups, such as m. quadriceps, in non-cooperating ICU patients.   "
148122|NCT01345448|"     The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular     pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that is applied     to the outside of one eyelid.   "
148123|NCT01345435|"     A multi-center, randomized, parallel, interventional, open label trial to compare Hemoglobin     A1C-lowering effect of conventional treatment and Smart Care Service in patients with type 2     diabetes.   "
148124|NCT01345422|"     Patients with dizziness presently undergo physical therapy rehabilitation. Our study will     study whether Wii Balance Board made by Nintendo Inc. will be helpful in patients with     dizziness. They will undergo dizziness evaluation to quantify their dizziness.   "
148125|NCT01345409|"     Recent research examines many types of complementary and alternative (CAM) therapies.     However, real-world use of CAM has been largely overlooked.      This project consists of four discrete sets of project activities (that largely follow one     another chronologically).      Phase1 uses information from the EMR (patient electronic medical records) to identify unique     clusters of patients with CMP (chronic musculoskeletal pain), their care within the health     plan, and to examine how those in unique clusters may have different uses for A/C     (acupuncture and chiropractic) services and/or differential outcomes associated with such     care.      Phase 2 will conduct a survey of CMP patients from KPNW (Kaiser Permanente Northwest region)     to establish a broad sample of patients and their use of out-of-plan CAM services.      Phase 3 will collect qualitative data (focus groups and individual interviews) from KP     members, KP providers, and acupuncturists and chiropractors from the community to examine KP     providers' decision to recommend A/C services, A/C services delivered to KP patients, and     patients' decisions to pursue and retain CAM care. A secondary purpose is to have KP members     with CMP review planned assessment instruments to improve understandability of the     instruments. They will provide feedback on: relevancy, any notable omissions of domains     important in patients' decision to use CAM services for pain treatment. They will also     provide insight to broader health and quality of life outcomes associated with such CAM     treatments.      Phase 4 is a prospective cohort study to evaluate health services/costs and broader clinical     and functional outcomes associated with the receipt of A/C relative to carefully matched     comparison participants receiving traditional CMP services.   "
148126|NCT01345396|"     Asthma is the most frequent respiratory disease during pregnancy. In a third of cases, the     level of asthma control can decrease during the pregnancy, especially between the 29th and     the 36th week. The occurrence of such complications are linked with a high asthma severity     level just before the conception and an history of respiratory complications in a previous     pregnancy. Many reviews and recommendations claim that pregnant women with asthma should be     included in an educational progamme. However, this is poorly studied. The purpose of this     study is to observe if an educational programme given before the 20th weeks of gestation has     an effect on asthma control until the end of gestation.   "
148127|NCT01345383|"     The purpose of this study is to study the impact of smoking in the preceding hours before a     bronchoscopy on the tolerance of this exam.   "
148128|NCT01345370|"     Treatment for newly diagnosed glioblastomas currently involves surgical resection followed by     Temozolomide chemotherapy with concomitant radiotherapy, and then 6 cycles of Temozolomide in     adjuvant. According to many studies, only those patients not expressing the enzyme repair     MGMT benefit from the adjunction of Temozolomide. Therefore, many patients receive     unnecessary treatment. The aim of this project is to compare different techniques for     analysis of MGMT in order to choose the approach with the best cost/utility ratio, which will     allow the selection of patients likely to respond to TMZ chemotherapy during the first course     of GBM treatment.   "
148129|NCT01345357|"     The primary objective of the study is to determine the maximum tolerated dose (MTD) of     CEP-9722 in combination with gemcitabine and cisplatin in patients with advanced solid tumors     or mantle cell lymphoma.   "
148130|NCT01345344|"     This study design has two components: 1) a cross sectional assessment of brain connectivity     and response to pain in healthy controls and demographically matched fibromyalgia patients,     and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to     either CBT (Cognitive Behavioral Therapy) or a Disease Education condition.      The investigators will evaluate 90 fibromyalgia patients who will receive CBT treatment once     a week for 8 weeks, for a total of 8 treatments. Baseline data from these patients will be     compared to results from 30 pain-free controls and 60 education program controls.      Participants will undergo experimental pain assessments as well as brain neuroimaging.   "
148131|NCT01345331|"     The Brigham and Women's Pain Management Center is conducting a research study for chronic     pelvic pain patients due to endometriosis. The study will assess the effect of     electro-stimulation for the treatment of Chronic Pelvic Pain. You may be eligible if you have     chronic pelvic pain due to endometriosis, are between the ages of 21- 64, and not taking     opioid medication (such as morphine or oxycodone). The study will require two visits, each     lasting about 2 hours. The study takes place at the Brigham & Women's Pain Management Center,     850 Boylston St., Chestnut Hill. Please contact Chrissie Cahalan at 617-732-9014 or     ccahalan1@partners.org if interested.   "
148132|NCT01345318|"     This is a multi-center Phase 2, open label, safety extension study in subjects with moderate     to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will     have completed the 12-week induction period of study B0151003 and will be enrolled as either     responders or non responders.   "
148135|NCT01345279|"     Indirect comparisons were performed using data from GOG-0179 versus GOG-0169 to permit     comparison of topotecan in combination with cisplatin versus cisplatin plus paclitaxel via     the common comparator of cisplatin monotherapy. Both GOG-0179 and GOG-0169 were conducted in     patients with stage IVB, recurrent or persistent carcinoma of the cervix, but there were some     differences between the respective study populations. Patients with prior chemotherapy were     eligible for GOG-0179 but ineligible for GOG-0169 (except when chemotherapy was used for     radiation sensitisation). Fewer patients had received chemotherapy as a radiosensitiser in     GOG-0169 (27%) than in GOG-0179 (~60%) and these patients were unevenly distributed between     treatment arms in GOG-0169. In addition, the proportion of patients receiving cisplatin as a     radiosensitiser in GOG-0169 is unknown. For these reasons, there are limitations associated     with the indirect meta-analysis.   "
148136|NCT01345266|"     This is a clinical study, with no investigational product, to characterise the inhalation     profiles of healthy volunteers, volunteers with mild, moderate and severe Asthma and     volunteers with mild, moderate and severe Chronic Obstructive Pulmonary Disease (COPD),     through the novel dry powder inhaler.   "
148137|NCT01345253|"     The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to     standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus     erythematosus (SLE) over a 52 week period.   "
148138|NCT01345240|"     This study has been designed to support the indication of the candidate vaccine (also     referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when     administered as a primary vaccination integrated into an Expanded Program on Immunization     (EPI) regimen to infants living in sub-Saharan Africa.   "
148139|NCT01345227|"     The goal of this study is to evaluate safety and feasibility of bone marrow (BM) as site for     islet transplantation (Tx) in humans. The investigators hypothesis is that BM represents a     better site than liver thanks to its potential capacity to favor islet engraftment in face of     a more easiness of access and bioptic follow up.   "
148140|NCT01345214|"     The primary objective of this study is to evaluate the safety and tolerability of ONO-7746     across multiple doses in patients with solid tumors and chemotherapy induced thrombocytopenia     (CIT) scheduled to receive at least two cycles of myelosuppressive chemotherapy on Day 1     every 21 days at the same dosages and schedule in the study. The secondary objectives are to     characterize the PK profiles of ONO-7746 and to explore the pharmacodynamic effect of     ONO-7746 on CIT.   "
148141|NCT01345201|"     This is an open-label Phase 1 dose escalation study of OMP-18R5 in subjects with a solid     tumor for which there is no remaining standard curative therapy and no therapy with a     demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers.     Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and     efficacy. No formal interim analyses will be performed.      Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon     enrollment, subjects will receive intravenous (IV) infusions of OMP-18R5 at a assigned dosing     schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there     is no evidence of disease progression or if the tumor is smaller, then subjects may continue     to receive IV infusions of OMP-18R5 every week until disease progression.      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose     escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled     in a cohort will not be treated on the same day. The dose may be administered at any time     during the day. Three subjects will be treated at each dose level if no dose-limiting     toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will be     expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be     dosed at that level and 3 additional subjects will be added to the preceding dose cohort     unless 6 subjects have already been treated at that dose level. Subjects will be assessed for     DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled     subjects, if appropriate, will occur after all subjects in a cohort have completed their Day     28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to     continue to receive weekly doses of OMP-18R5 until disease progression. An additional 14     subjects will be enrolled at the highest dose level that result in < 2 of the 6 subjects     experiencing a Grade 3 (not including a Grade 3 infusion reaction that resolves in 24 hours)     or 4 adverse event (DLT).   "
148142|NCT01345188|"     Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and     shortness of breath despite conventional medical therapy and/or revascularization. The     purpose of this study is to determine the efficacy of taking Ranexa versus placebo in     patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional     medical therapy and/or percutaneous revascularization.   "
148143|NCT01345175|"     The most common long-term problems after rectal surgery are bowel problems. These problems     can include needing to pass bowel movements a lot, loose or mushy stools, inability to fully     clear your bowels, and/or poor control of gas and stool. The investigators believe that a     major cause of these problems is too much bacteria in the bowel and treatment with antibiotic     tablets will hopefully help improve these bowel problems. In order to test this idea, the     Colorectal Surgery Service of Memorial Sloan Kettering Cancer Center is sponsoring a clinical     trial. This trial will compare the antibiotic rifaximin and a placebo (a harmless tablet that     has no effect) in the treatment of these bowel problems. Following this we will attempt to     see if another antibiotic metronidazole also helps to treat these bowel problems. Both     Metronidazole and rifaximin are well established drugs that have minimal side effects.   "
148144|NCT01345162|"     The aim of the study is the assessment and management of Acute Post-herniotomy Pain using two     different therapeutical protocols per os: ketorolac versus association of     acetaminophene+tramadol.   "
148145|NCT01345149|"     Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight     gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.   "
148146|NCT01345136|"     The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth     of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients. Secondary objectives     include determining if RAD001 treatment will improve hearing ability in NF2 patients.      RAD001 is an oral drug that is approved by Food and Drug Administration (FDA) for other types     of tumors, it is not approved by the FDA for treatment of NF2 related tumors.   "
148164|NCT01344902|"     The purpose of the study is to determine if it is possible to detect more pre-cancerous     lesions in colon when using fluorescence technology.   "
148165|NCT01344889|"     This observational study will assess factors leading to dose reductions/treatment     discontinuations and the effect on sustained virological response in patients with chronic     hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and     ribavirin. Data will be collected from each patient for the duration of their treatment and     for up to 6 months thereafter.   "
148166|NCT01344876|"     To determine the maximum tolerated dose (MTD) of OPB-51602   "
148148|NCT01345110|"     Longitudinal observational study of cognitive functions, physical health and biological     parameters in the whole population living in Abbiategrasso born between 1935 and 1939,1773     subjects, followed for six years in order to know the prevalence and the incidence of     dementia and risk and protective factors of normal and pathological mental aging.      The peculiarities of this study that must assure the outcome efficacy are:        -  Selected age: since 70-75 years old people represents a transition age from adulthood to          old age, it is of special interest to study the evolution of psychic and physical          functions of this population        -  Whole population not a sample study        -  Location: the small area involved (Abbiategrasso is a town of 30.000 inhabitants)can          contribute to guarantee more homogeneity among the subjects and reduce undesired          variability        -  multidimensional assessment(biological, clinical, social, psychological data collected)          After initial screening, the recruited population will be followed up for two more times          (every two years )   "
148149|NCT01345097|"     The investigators determined whether        1. new short, metaphyseal-fitting cementless anatomical femoral stem provides major          functional improvements        2. radiographically secure implant fixation is achieved with this new stem        3. the bone content is preserved at the baseline level or above at the final follow-up        4. these procedures are associated with early failure and complications.   "
148150|NCT01345084|"     Primary: to compare the overall survival defined as the time elapsed between the     randomization date and death due to any cause, in both treatment groups.      Secondary: to compare the progression-free survival, incidence of locoregional failure, site     of the first recurrence/progression, objective response rate assessment, quality of life     assessment and incidence of adverse events.   "
148151|NCT01345071|"     The first objective of the study is to evaluate a treat to target treatment strategy in women     with moderate to high disease activity of RA and a pregnancy wish, from pre-pregnancy. The     treatment strategy is based on deliberate treatment decisions to lower disease activity,     including the continuation or start of biological treatment (in particular anti-Tumor     Necrosis Factor [anti-TNF]), based on a standard care protocol in the Erasmus MC. The second     objective is to evaluate the safety of the use of anti-TNF during pregnancy among women with     a rheumatic disease that require the use of anti-TNF before or during pregnancy.   "
148152|NCT01345058|"     This is a study to determine whether a combination of low dose lacosamide and levetiracetam     is more effective than high dose levetiracetam in patients who have failed low dose     levetiracetam.   "
148153|NCT01345045|"     People with diabetes can, over time develop nerve damage throughout the body with symptoms     such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.   "
148154|NCT01345032|"     The purpose of this study is to test two different interventions of nutrition follow up after     discharge from geriatric ward in undernourished geriatric patients. The patients are     randomized to a home visit arm, a telephone consultation arm, or a control arm. Patients in     the home visit arm and their home care helper will get visits from a clinical dietician at     one week, two weeks and four weeks after discharge, in order to follow up on the nutrition     intervention. Patients in the telephone consultation arm and their home care helper will be     contacted by a clinical dietician at one week, two weeks and four weeks after discharge, in     order to follow up on the nutrition intervention. The control arm will not be contacted.      The primarily outcome is functional ability. Secondary outcomes are quality of life,     readmission and mortality.   "
148155|NCT01345019|"     The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in     the treatment of bone disease from multiple myeloma.   "
148156|NCT01345006|"     This is a safety and tolerability trial to evaluate the effect of subretinal injection of     human embryonic stem cell derived retinal pigment epithelium cells in patients with     Stargardt's Macular Dystrophy (SMD).   "
148157|NCT01344993|"     This is a safety and tolerability trial to evaluate the effect of subretinal injection of     human embryonic stem cell derived retinal pigment epithelium cells in patients with dry Age     Related Macular Degeneration (AMD) and to perform exploratory evaluation of potential     efficacy endpoints to be used in future studies retinal pigment epithelium (RPE) cellular     therapy.   "
148158|NCT01344980|"     The investigators are comparing the combination of a stainless steel repair and aggressive     early active range of motion rehabilitation protocol for flexor tendon lacerations in the     hand with a current, accepted treatment offered at our institution. Outcomes to be assessed     will be time to return to work, joint range of motion in the injured fingers, and any     potential complications that may arise (ex: surgical infections or repair rupture). All     proposed treatments included in this study are currently being offered at our institution,     but not in a randomized fashion.   "
148159|NCT01344967|"     Bone is the most common site of spread of breast cancer and bone metastases will occur in     roughly 70% of women with advanced disease. These patients are at risk of developing bone     complications that cause significant impact on both patient morbidity and mortality. Close to     two-thirds of women with bone metastases will go on to develop at least one of these     complications, termed a skeletal related event (SRE), defined as 1) pathological fractures,     2) pain requiring radiation or surgical intervention, 3)spinal cord compression, and 4)     hypercalcemia. In addition to SREs, most breast cancer patients with bone metastases have     some degree of pain associated with their disease. Understandably these factors negatively     impact their quality of life. Furthermore, the development of an SRE in this population has     been shown to be associated with shorter overall survival. Prevention or delay in onset of     these complications is therefore an important therapeutic goal.   "
148160|NCT01344954|"     The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402     administered as a single intravenous infusion for the prevention of VTE in subjects     undergoing total hip replacement surgery.   "
148161|NCT01344941|"     The primary objectives of this study is to        -  Define the envelope-specific B-cell and T-cell responses in humans who have received a          St. Jude HIV-1 vaccine.        -  Describe mechanisms of HIV-1 envelope processing and consequent B-cell and T-cell          activities.   "
148178|NCT01344707|"     The purpose of this study is to determine the Maximum Tolerated Dose, Dose Limiting     Toxicities and optimal dosing schedule of 4SC-202 investigating its safety, tolerability and     pharmacokinetics.   "
148169|NCT01344824|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving     carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium     together with bevacizumab works in treating patients with stage III or stage IV non-small     cell lung cancer who are light or never smokers.   "
148170|NCT01344811|"     A randomized, open, parallel, multi-center trial to evaluate weight loss efficacy of Smart     Care Service in obese patients with metabolic syndrome.   "
148171|NCT01344798|"     The purpose of this trial is to study the evaluation of clinical safety and feasibility of     gene therapy in patients with limb girdle muscular dystrophy type 2C     (gamma-sarcoglycanopathy).   "
148172|NCT01344785|"     The purpose of this study is determine the relationship between pain and protrusion of the     implant after surgery for a intertrochanteric fracture.   "
148173|NCT01344772|"     The primary aim of this study was to determine the Harris hip score as an evaluation of hip     function, in mentally competent elderly patients (>65 years old) treated with either THR or     IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare the     rate of reoperations and complications between the two groups.   "
148174|NCT01344759|"     The purpose of this research study is to examine the effects of two commonly used anesthetic     drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in     children, adolescents, and young adults with a history of obstructive sleep apnea (OSA)     having an MRI scan.      The results of this study will help in making the best decisions regarding the anesthesia     medications that are most appropriate for children, adolescents, and young adults with OSA     during MRI studies.   "
148175|NCT01344746|"     Our goals are to demonstrate an active leukotrienes (LTs) mediated inflammatory response is     involved in pathophysiology of sleep-disordered breathing (SDB), and to provide a theoretical     evidence for LTs modify therapy in treating pediatric patients with SDB.      The investigators have hypothesized that the pathophysiology of pediatric SDB involves     specific systemic and local upper airway inflammatory response mediated by LTs.        1. LT concentration assays reveal higher levels in serum for both leukotriene B4 (LTB4) and          cysteinyl leukotrienes (CysLTs) and in morning urine for LTE4 of SDB children, in          comparison to healthy ones, and LTs productions emerge disease severity-dependent          increases.           There is a positive correlation between LTs production and other systemic markers such          as neutrophil counts and high sensitive C-reactive protein (hsCRP).        2. Children with SDB have higher leukotriene receptor-1 (LT1-R) and leukotriene receptor-2          (LT2-R) expressions in adenotonsillar tissues of SDB children compared to recurrent          infectious tonsillitis subjects.        3. Levels of LTs are positively correlated with body mass index (BMI) z-score, waist height          ratio (WHtR), adenotonsillar size and polysomnography (PSG) indices including          apnea-hypopnea index (AHI), obstructive apnea index (OAI), oxygen desaturation index          (ODI), arousal index, percentage of time spend saturation lower than 90% (SLT90%) and          negatively correlated with mean and minimal pulse oximetric saturation (SpO2), which          indicates synergistic role of obesity and hypoxia are the determinants of LTs production          in SDB.        4. In adenotonsillar mixed cell culture system, the addition of LTs can increase cellular          proliferation rates and exhibit dose-dependent responses, whereas leukotriene receptor          antagonists (LTRAs) elicit dose-dependent cellular reductions.   "
148176|NCT01344733|"     The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of     HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the     study. No efficacy and tolerability of pharmacological treatments will be assessed. Patients     matching inclusion and exclusion criteria will be enrolled consecutively; each investigator     will include the first 10 to 40 patients that will be visited as treatment resistant MDD.   "
148177|NCT01344720|"     This randomized, single-blind, parallel-group study will investigate the efficacy and the     tolerability of a combination treatment of etoricoxib (30 mg/day) plus controlled-release     oxycodone (10 mg/day) compared with a titrated dose of etoricoxib up to 60mg/day as     monotherapy , in patients with Chronic Low Back Pain (CLBP) who have not responded to the     starting dose of Etoricoxib 30mg/day. A common clinical question is that is it better to     increase the dose of the current monotherapy or to combine both treatments early on, in     patients who do not respond to standard start doses of NSAIDs like etoricoxib.   "
148180|NCT01344681|"     This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic     refractory fever. The investigators evaluate efficacy and safety of micafungin sodium     (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a     control and this study is prospective, randomized, non-inferiority trials.      Therefore, this study was planned for review of the safety and efficacy in korean patients.   "
148181|NCT01344668|"     The primary hypotheses are that the intervention will improve A1C, blood pressure, lipids,     weight, self-efficacy, self-management behaviors, and use of clinical services at 12 and 24     months follow-up.   "
148182|NCT01344655|"     This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small     airways physiological parameters in COPD patients.   "
148183|NCT01344642|"     The purpose of this study is to determine if the Oragene.RNA kit is able to detect HIV RNA in     saliva.   "
148184|NCT01344629|"     To investigate the bioequivalence of telmisartan administrated in two different ways: both in     telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg     tablet and amlodipine 5 mg tablets (R) in concomitant use   "
148185|NCT01344616|"     Timely screening and management of modifiable conditions can reduce preterm births, yet     providing effective prenatal risk management systems to meet the unique needs of medically     underserved populations is complex. If the proposed system proves to be effective in reducing     preterm births it can improve maternal and child quality of life as well as reduce the     economic burden of preterm births in the U.S.   "
148200|NCT01344486|"     Full conditioning of the peritoneal cavity during laparoscopic surgery will decrease     post-operative pain, inflammation and adhesion formation.      Full conditioning will decrease an inflammatory response of the peritoneum and decrease pain     and adhesion formation.   "
148494|NCT01340664|"     The purpose of this study is to evaluate the efficacy and safety of 2 different doses of     canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are     receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have     inadequate glycemic (blood sugar) control.   "
148186|NCT01343641|"     This year-long investigator-initiated study is designed to determine effects of MK-0677, a GH     secretagogue, in renal patients. It is a double-blind, placebo-controlled trial employing the     following procedures: Informed consent process, followed by evaluation and screening tests to     confirm patients' eligibility. Patients whose screening laboratory results for glycated     hemoglobin level, thyroid function, or liver function exceed protocol eligibility criteria     will not be randomized. Other exclusions are Congestive Heart Failure Class III or IV by the     New York Heart Assocation's (NYHA) Guidelines and specified cardiovascular disorders within     six months of baseline visit and muscle weakness associated with neuromuscular or     neurological disorders. Before the subject begins taking the experimental drug MK-0677 or     placebo, baseline assessments of subjects' hormone and cytokine levels, physical condition,     body mass (determined by a DEXA scan), strength and functionality, and appetite will be     obtained. In addition, quality of life assessments (SF-36) will be administered. This study's     primary outcome is an increase in lean body weight. Secondary outcomes are cytokine and     hormone levels, including, leptin, insulin, ghrelin, TNF- alpha, CRPs, IL-1, IL-6, and IL-10,     ghrelin associated esterase and adiponectin, nutritional status, quality of life (QoL), food     appreciation, physical function and economic impact. 70 subjects will be the enrollment     target. This number was determined to offset projected screen failure and early withdrawal     rates, and to ensure that 42 subjects complete the study.   "
148187|NCT01343628|"     Alcohol dependence, or alcoholism, affects approximately 14 million Americans. Currently,     only three pharmacotherapies (disulfiram, naltrexone, and acamprosate) have been approved for     the treatment of alcohol dependence and these medications are, at best, moderately     successful. Thus, there is a great need for the examination of other biological systems,     which contribute/influence the drug reward/addiction pathways within the brain, such that the     discovery of new targets and new pharmacotherapies will be possible. Other biological systems     in addition to dopamine, such as serotonin, and norepinephrine (NE) are thought to be     important in several aspects of addiction, including reward, craving and depression.      This study will examine the effects of a 5 day course of atomoxetine (a selective NE     transporter (NET) inhibitor) (80 mg/day; Strattera or placebo) on alcohol-elicited craving     and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the fact     that it targets NET, neither of which has heretofore been examined in the context of alcohol     dependence. It is hopeful that this study, of 64 total individuals, will provide the PI with     sufficient preliminary data to submit a subsequent R01 application to study atomoxetine and     the involvement of specific single nucleotide polymorphisms within the NET gene on     alcohol-related phenotypes in alcohol dependent and non-dependent populations. The long-term     objective of this research is to develop more efficacious treatment interventions for alcohol     abuse and dependence.   "
148188|NCT01343615|"     The purpose of this study is to determine the clinical and radiologic implications of the     intraoperative microemboli during carotid revascularization.   "
148189|NCT01343602|"     The aim of this study is to evaluate the efficacy of a modified approach of constraint     induced movement therapy (CIMT at home) for chronic stroke patients, compared to     conventional physiotherapy and occupational therapy (therapy as usual) with regard to the     ability to participate in everyday activities.   "
148190|NCT01343589|"     To investigate the effect of milk delivered from mountain-pasture grazing cows on risk     markers of the metabolic syndrome and type-2 diabetes with the effect of conventional Danish     milk. The study should reveal the importance of phytanic acid content for these effects.   "
148191|NCT01344603|"     In the present study the investigators test the hypothesis that the epidural anesthesia added     on the general anesthesia is able to improve patient's outcome.   "
148192|NCT01344590|"     Vascular access via central venous lines (CVL) is essential to the care of many patients in     the intensive care setting. While the value of these lines for the management of critically     ill patients is generally accepted, the potential for line-associated blood stream infection     is a known complication of the use of this intervention.      Ethanol is an effective antimicrobial agent with activity against a broad spectrum of human     pathogens.      The purpose of this study is to evaluate the effectiveness of daily treatment of the catheter     lumen with ethanol to prevent central line associated blood stream infections (CLABSI). The     hypothesis is that this treatment will reduce the incidence of CLABSI compared to maintenance     of the lines with normal saline alone.   "
148193|NCT01344577|"     The purposes of this study are : (first) to evaluate comparatively the effectiveness of 2     HA-based biomaterials when used for socket preservation with Buccal Plate Augmentation     technique; (second) to evaluate clinical outcomes of socket preservation procedures performed     using the Buccal Plate Augmentation technique.   "
148194|NCT01344564|"     The purpose of this study is to determine if patients initiating androgen deprivation therapy     (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate     after an initial three-month period without a rise in serum testosterone. The investigators     expect testosterone will quickly and reliably reach castrate levels after initiation of ADT     and will remain castrate during the transition, and there will be no testosterone surge     after leuprolide injection.   "
148195|NCT01344551|"     To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function     in healthy older adults.   "
148196|NCT01344538|"     The purpose of this study is to determine if ginger root extract when taken daily for 28 days     is able to decrease levels of inflammatory chemicals called eicosanoids in the gut tissue of     people who are at normal risk and those at increased of developing colorectal cancer compared     to people taking placebo.   "
148197|NCT01344525|"     Obese individuals that undergo major intervention such as a low-calorie formula diet program     or bariatric surgery with the result of substantial weight loss (> 10%) are included and     followed-up for at least 3 years. Weight changes and excess weight loss as well as measures     of quality of life are monitored. In addition, biomaterials will be collected from these     individuals every 6 months for measurement of parameters related to obesity-associated     gastrointestinal (GI) impairments such as change in GI hormone levels, change in GI     microbiota, or enhanced bacterial translocation. Moreover, micronutrient and metabolomics     analysis will be performed. This project allows comparison of non-surgical and surgical     intervention and enables to asses the anticipated relationship between obesity and the GI     tract in humans in the future.   "
148201|NCT01344473|"     Fixed dental braces are associated with the risk of developing White Spot Lesions (WSLs),     which appear as white chalky marks on the teeth. They develop as a result of the acid     produced by bacteria in dental plaque dissolving the outer surface of the tooth, known as     demineralisation. Recently, amorphous calcium phosphate (ACP) stabilised by casein     phosphopeptide (CPP) has become available, and it is reported to help rebuild the surface of     teeth which have WSLs. CPP-ACP is available incorporated into a crème known as Tooth Mousse     (TM). While there appears to be sufficient evidence regarding the use of CPP-ACP in promoting     general remineralisation, for the first time this study aims to examine the use of CPP-ACP to     treat WSLs in post-orthodontic participants.   "
148202|NCT01344460|"     Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic     resonance angiography) will be invited to participate in the study and subjects will be     involved in the study for between 2 and 12 days. Two to three visits to the study doctor will     be required.      This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA     images taken without contrast agent using images from a CTA as the standard of reference,     which may have been performed up to 60 days prior to enrolment. If a CTA has not been     performed in this prior time period, a CTA is required for the study.      MRA and CTA images will be collected for an independent review (blinded read).   "
148203|NCT01344447|"     Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic     resonance angiography) will be invited to participate in the study and subjects will be     involved in the study for between 2 and 12 days. Two to three visits to the study doctor will     be required.      This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA     images taken without contrast agent using images from a CTA as the standard of reference,     which may have been performed up to 60 days prior to enrolment. If a CTA has not been     performed in this prior time period, a CTA is required for the study.      MRA and CTA images will be collected for an independent review (blinded read).   "
148204|NCT01344434|"     This study hypothesizes that renal transplantation candidates are diagnosed with significant     Coronary Artery Disease (CAD) equal with non-invasive modalities as with invasive modalities.     Therefore the investigators are investigating the ability of coronary computed tomographic     angiography (cCTA), myocardial perfusion scintigraphy (MPS), acoustic CAD Patch and     combination hereof to detect CAD as defined by invasive Coronary angiography (CAG).   "
148205|NCT01344421|"     The purpose of this study is to examine the movement pattern in patients with hip dysplasia     preoperative, six and 12 month after minimally invasive approach for Periacetabular osteotomy     (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and     historical data.   "
148206|NCT01344408|"     BACKGROUND A Cochrane review from 2003 found that about 30% of people 65 years or older each     year fall and that number is even higher for elder people living in institutions. Falls are     the cause of 95% of all hip fractures, resulting in prolonged hospitalization and prolonged     disability. In patients who are referred to the emergency room after unexplained fall, a     study of 564 patients showed that 80% of the patients had vestibular symptoms characterized     by balance problems, nausea, impairment, vomiting, and dizziness. 41% of the patients had     dizziness suggesting a dysfunctional vestibular system called vestibular dysfunction. In     patients with vestibular dysfunction, vestibular rehabilitation (VR) can reduce fall risk.     Several studies show however that the elderly has a decreased compliance in relation to the     performance of home exercise.      A solution to support the older vestibular rehabilitation process and to maintain the     achieved level of functionality after the rehabilitation process is the computer-training     program Move It To Improve It (MITII). Based on individual studies and tests therapists     develop a personalized rehabilitation program permanently corrected, modified and adjusted.     The system generates feedback to the therapists at hospital with information about the     person's daily training and scores of individual exercises. The Web cam makes it possible to     make video footage and pictures to be used in the feedback information. The system also     establish direct communication between users and therapists. The web community provide the     framework for a telerehabilitation system, which means that the hospital can service more     users in the same period.      The ph.d. consist of three studies which has the purposes:      To compare a computer exercise program (Mitii) with conservative home-training according to     printed instructions in the rehabilitation of patients with vistibular dysfunction in an     outpatient clinic To investigate whether the effect of vestibular rehabilitation is preserved     three months after the completion of supervised training in an outpatient clinic for specific     vestibular rehabilitation and whether a computer assisted home training program (Mitii) is     superior to printed instructions in this respect To evaluate patient experience and barriers     for the use fo the computer assisted rehabilitation of patients with vestibular dysfunction   "
148207|NCT01344395|"     The primary aim of this study is to evaluate if multiple postoperative administrations with a     solution of ropivacaine, ketorolac and epinephrine into the operating field through a     catheter would affect morphine consumption. Secondary end-points are pain intensity, side     effects and length of stay.   "
148208|NCT01344382|"     This project will modify Community Reinforcement and Family Training (CRAFT; n=15) and     Alanon/Naranon Facilitation (ANF; n=15) for use with parents who are concerned about an     out-of-treatment adolescent. ANF was selected as a comparison because Alanon and Naranon are     the most commonly available method for helping family members. The investigators will compare     CRAFT for parents (CRAFT-P) (n=77) and ANF (n=77) to determine if there is a significant     difference in adolescent treatment entry. Parents will attend a maximum of 18 sessions with a     family specialist and also complete questionnaires periodically over a 12-month period.     Parents' adolescents will have the opportunity to participate in the study by completing     questionnaires at the same time points as their parent. Our primary hypothesis asks whether     participants who are enrolled in the CRAFT-P condition will report more adolescent treatment     entry than the ANF condition. Our secondary hypotheses examine: 1) reductions in adolescent     substance use and behavior problems in the CRAFT-P group compared to the ANF condition, 2)     improvements in parenting skills in the CRAFT-P group compared to the ANF condition and 3)     significant pre to post treatment effects for improvements in social functioning, mood, and     in parent-adolescent relationship satisfaction.   "
148209|NCT01344369|"     The purpose of this study was to evaluate the relative bioavailability of a test formulation     of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals,     USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol     and ferrous fumarate) 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott) under fed conditions     in healthy, non-tobacco using, adult female subjects.   "
148210|NCT01344356|"     This study will evaluate the local control rates as well as acute and late toxicity rates of     stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck     tumors.   "
148211|NCT01344343|"     There is preliminary evidence that suggests early surgical treatment of a hip fracture may     improve patients' outcomes. The investigators propose to do a pilot randomized controlled     trial (RCT) to assess the feasibility of a large RCT comparing accelerated surgical repair     (i.e. surgery within 6 hours of a hip fracture diagnosis) versus standard care (typically     surgery after 36-48 hours).   "
148212|NCT01344330|"     This research study will assess cruciferous vegetable intake in patients presenting for     screening colonoscopy and correlate intake with histone status and histone deacetylace (HDAC)     expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs). The     investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker of     cruciferous vegetable intake.   "
148213|NCT01344317|"     Introduction: Methylxanthines and doxapram have been widely used for the treatment of apneas     of prematurity. Both substances have effects on the central nervous system. While there are     data available concerning the use of caffeine (the methylxanthine used at our NICU) even     proposing a positive effect on neurodevelopmental outcome of very preterm infants, there are     data which suggest a negative effect of the central stimulants doxapram on longterm outcome     in this group of infants. Nevertheless concerning both medications only few studies have been     published and only scarce data are available concerning the effect of these medications on     brain activity of very preterm infants until now.      The aim of this study: is the assessment of the effect of stimulating substances on brain     activity of preterm infants born below 30 weeks of gestation and their longterm     neurodevelopmental follow-up.      Methods: This study is a prospective study including preterm infants born below 30 weeks of     gestational age. Brain activity is measured by one-channel amplitude-integrated EEG (aEEG).     The first aEEG measurement is performed without caffeine and/or doxapram medication. At least     one hour of brain activity is registrated. The second measurement is done at least 24 hours     after the start of caffeine and/ or doxapram treatment.      The percentage of different background patterns, the occurrence and duration of     sleep-wake-cycling, and the occurrence and duration of seizures is assessed and analysed.     Neurodevelopmental outcome is assessed at one and two years of corrected age by assessment of     the Bayley Scales of Infant Development II and standardized clinical neurological     examination.   "
148214|NCT01344304|"     The object of this study is to evaluate the superiority of aprepitant therapy with a     5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a     5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first     course chemotherapy.   "
148215|NCT01344291|"     Prolactinoma is the most prevalent anterior hypophysis tumor. The principal treatment for     this disorder is Dopamine agonist drugs including bromocriptin and Cabergoline. However, 50%     of Bromocriptin treated and 17% of Cabergoline treated patients are resistant to these drugs.     Curcumin is the main derivative of turmeric ,an old spice which is used frequently in Indian     and Iranian cuisine. It has been proved that curcumin can reduce mammotrope cells     proliferation and also intracellular hormone production. The purpose of this study is to     evaluate the effect of turmeric on prolactinoma patients.   "
148216|NCT01344278|"     The main goal of this study is to examine the comparative effectiveness of diabetes     prevention strategies in women with Gestational Diabetes Mellitus (GDM) on the control of the     following conditions: obesity, hyperglycemia, hypertension and depression. This randomized     lifestyle intervention study will be conducted at Kaiser Permanente Northern California.     Women in the intervention will receive a letter on gestational weight gain during pregnancy     and in the postpartum period, a curriculum of individualized lifestyle counseling via     telephone, augmented with e-mail and an interactive Web site. Patients randomized to the     usual care arm will receive the standard-care telephone calls from the Perinatal Center     during pregnancy and the Center's printed educational materials postpartum. Outcomes will be     assessed through the electronic medical record and patient surveys conducted during pregnancy     and at 6-weeks, 6- months and 1-year postpartum.   "
148217|NCT01344265|"     The investigators hypothesized that the serum B-type Natriuretic Peptide (BNP) level may be     correlated with global end diastolic volume (GEDV) as measured by transpulmonary     thermodilution technique (PiCCO). The rationale is that some animal studies have proven that     BNP is released from ventricular myocardium in response to physical expansion. Such physical     expansion can be measured by GEDV. If the hypothesis can be confirmed with our study, the     serum level BNP can be used to monitor volume status of critically ill patient, instead of     the invasive monitoring system.   "
148218|NCT01344252|"     The options for anesthesia in cataract surgery described are: general, regional or local. The     local strategy, it may be by periocular blocking(subtenon, peribulbar or retrobulbar),     subconjunctival or topical. The risks faced by subconjunctival, peribulbar or retrobulbar,     have made subtenon and topical strategies the most used. Likewise, to improve the     effectiveness of the topical strategy was added gel topical lidocaine and intracameral dose     of lidocaine.      Subtenon and topical anesthesia are two safe strategies and there were performed multiple     studies showing that both are effective in controlling pain, but showing a slight superiority     of subtenon. This difference does not appear to be clinically significant. In turn, the     addition of gel and intracameral anesthesia, improved pain control. However, lack evidence to     compare patient preference when using topical gel and intracameral anesthesia versus     sub-Tenon anesthesia.      Multiple advantages has the topical anesthesia. Besides being a safe strategy for the     patient, offers a rapid visual recovery, no generates blepharoptosis or diplopia     postoperatively, subconjunctival hemorrhage and chemosis.      Because of this the investigators plan to conduct a study comparing the efficacy of gel     topical and intracameral anesthesia versus subtenon anesthesia in cataract surgery with     scleral incision, assessing the patient's preference Hypothesis: Topical administration of     lidocaine in gel and intracameral anesthesia is a better strategy that subtenon anesthesia in     cataract surgery   "
148219|NCT01344239|"     To investigate whether limb remote ischemic preconditioning (LRIP) has protective effects     against intestinal and pulmonary injury in patients undergoing open infrarenal abdominal     aortic aneurysm (AAA) repair.   "
148220|NCT01344226|"     Investigate the intraocular pressure(pressure inside the eye) of patients who are treated     with Lotemax after undergoing cataract surgery.   "
148221|NCT01344213|"     To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of     intrathecal morphine for patients after total knee arthroplasty.   "
148251|NCT01343823|"     A double-blind, randomized, controlled trial comparing the safety and effectiveness of     conventional therapy with ecallantide to conventional therapy with placebo.   "
148495|NCT01340651|"     The purpose of this study is to determine the safety and tolerability of ruxolitinib     (INCB018424) sustained release (SR) formulation in participants with primary myelofibrosis     (PMF), post-polycythemia vera MF (PPV-MF), and post-essential thrombocythemia MF (PET-MF).   "
148222|NCT01344200|"     Background: Celecoxib is effective for reducing postoperative pain in adults. Children use     celecoxib more rapidly than adults and require higher doses. Celecoxib is partially     metabolized in the liver by a certain enzyme. A person's genetic variation of this enzyme can     influence how well their body uses Celecoxib. Understanding the blood and cerebrospinal fluid     (CSF) profile of celecoxib in children and the influence of genetics on metabolism would help     to develop appropriate celecoxib dosing in children for various treatment options.      Objective(s) and Hypothesis: Our primary objective will be to create a pediatric profile of     celecoxib in the blood and the central nervous system as well as explore the relationship     between CYP2C9 polymorphisms and documented adverse events      The investigators hypothesize that the CSF concentrations of Celecoxib post dose are lower     than plasma levels, take longer to reach peak concentration and are directly related to dose,     genetics, and age. The investigators expect that Celecoxib will improve quality of life and     reduce discomfort when administered before and after a lumbar puncture and bone marrow     aspirate.      Potential Impact: The results of this study will establish the safety of celecoxib in     children as well as help us define the best dosing for acute pain. It may also help reduce     the incidence of acute pain evolving into chronic pain. Finally, it may provide insight into     celecoxib's future use in chemotherapy.   "
148223|NCT01344187|"     The objectives of this study are to evaluate the safety and efficacy of corneal collagen     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as     compared to placebo in impeding the progression of, and/or reducing, maximum corneal     curvature.   "
148224|NCT01344174|"     This is a randomized, open label study evaluating the efficacy and safety of glucocorticoids     in patients with HBV associated pre-ACLF.      Sponsor: Department of infectious diseases, Southwest Hospital.      Indication: HBV associated acute-on-chronic pre-liver failure(pre-ACLF-HBV).      Objective: To evaluate the efficacy and safety of glucocorticoids in patients with     pre-ACLF-HBV.      Trial Design: Randomized, open label study. Patients with pre-ACLF-HBV will be randomized 1:1     to One of the two groups:      A)Dexamethasone 10mg were intravenously injected po daily for the first 5 days, in     combination with continued lamivudine 100mg po daily and traditional supporting treatments     for 13 weeks. B)Control group. Any glucocorticoids will be not given in all patients.     Continued lamivudine 100mg po daily and traditional supporting treatments will be given for     13 weeks.      Number of patients: Approximate number of patients to be randomized: N=200 (100 patients in     each group).      Length of study: Screening period: 3 days; treatment period: 13 weeks.      Duration of study: 30 months after first patient randomized, including an recruitment period     of 26 months.      Investigational treated regimen:Dexamethasone 10mg, iv, once day for 5 days.      Concomitant and Comparative regimen: Lamivudine 100mg po daily, traditional supporting     treatments.      Assessments of Efficacy Primary endpoint: the survival rate at week 13. Secondary     endpoint:①The levels of serum T-Bil ≤ 51.3µmol/L;②PTA ＞80%.      Safety: Adverse events, vital signs, and laboratory tests.      Procedures(summary): After signing informed consent and meeting screening parameters,     patients will be randomized to one of the two treatment groups as described under trial     design above. After randomization patients will be seen for evaluation at days     5,10,14,21,28,42,56,70,84,91.      Statistical analysis: Assume 1:1 randomization. The sample size is calculated for the primary     efficacy variable, the survival rate. Assuming the survival rate equals to: 90% for group A     and 50% for group B. 100 patients in each group are required to yield a 80% chance of     detecting such a difference when a two-tailed test is employed at the 0.05 significance     levels. Every eligible subject will be assigned with a randomization code and receive one of     the two treatments, according to the sequence of enrolled.   "
148225|NCT01344161|"     The investigators investigated the effect of vitamin D3 supplementation on metabolic profile     (anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices) in     overweight or obese women.   "
148226|NCT01344148|"     To determine the best time to begin anti-HIV(Acquired Immunodeficiency Syndrome) treatment in     individuals who co-infected with HIV and tuberculosis (Tb). This prospective, randomized     study is being conducted on HIV/Tb co-infected patients in China to evaluate and compare the     efficacy of antiretroviral therapy after 2 weeks TB treatment versus deferred ART initiated 8     weeks after initiation of TB treatment.   "
148227|NCT01344135|"     To study in clinically stable Chronic Obstructive Pulmonary Disease (COPD) patients with     muscle atrophy:        1. The short-term effects of 4 months exercise training including nutritional          supplementation versus exercise training alone on physical functioning (skeletal muscle          strength and exercise capacity) and body composition.        2. The long-term effects of 4 months of exercise training and nutritional supplementation          followed by 8 months of nutritional counseling (with supplementation on advice) and          feedback on physical activity level versus 4 months of exercise training and 8 months          with feedback on physical activity level alone on physical functioning, body composition          and cardiometabolic risk profile;        3. The cost-effectiveness of exercise rehabilitation and nutritional intervention versus          exercise rehabilitation alone.   "
148228|NCT01344122|"     The goal of this study is to see whether or not a strategic planning process is able to     introduce and sustain improvements in the working relationship between probation/parole     departments and community-based addiction treatment agencies that provide medication assisted     therapy (MAT) for individuals with opioid or alcohol dependence. In addition, this study     seeks to improve probation/parole agency personnel's knowledge and perceptions about MAT, and     increase the number of appropriate referrals to community treatment agencies that provide     MAT. There are three phases to this study. Phase 1 includes a pilot study to determine the     quality and availability of client level records and the collection of baseline data (the     pilot study protocol was previously submitted to TMH IRB). Phase 2 will consist of a     Knowledge, Perceptions and Information (KPI) intervention during which probation/parole     agencies will undergo training to increase knowledge about the effectiveness of MAT, and     complete a post training assessment to evaluate the effectiveness of the KPI intervention.     During Phase 3, probation/parole agencies will be randomly assigned to a 12-month     Organizational Linkage Intervention (OLI) condition or to control (no further intervention).     Agencies assigned to the OLI will establish a Pharmacotherapy Exchange Council (PEC) that     consists of staff from both the probation/parole and community treatment agencies. The PEC     will undergo a strategic planning process to increase the availability of MAT for opiate     and/or alcohol dependent individuals who are on probation/parole.   "
148229|NCT01344109|"     This is a pilot study evaluating the use of tumor derived exosomes as a marker for response     to therapy in women receiving neoadjuvant chemotherapy for newly diagnosed breast cancer.     Tumor derived exosome analysis may be a novel diagnostic and prognostic biosignature in     breast cancer, which could prove to be a tool for earlier diagnosis, more effective     treatments, and improved markers of response in order to increase survival rates.   "
148425|NCT01341483|"     The purpose of this study is to determine the proportion of men with known or suspected     coronary artery disease (CAD) and/or peripheral arterial disease (PAD) that have angiographic     identifiable erectile related artery (ERA) atherosclerotic disease defined as at least one     ERA stenosis greater than or equal to 50% (per core lab Quantitative Vascular Analysis -     QVA).   "
148230|NCT01344096|"     In Gaucher disease type I bleeding is a common presenting symptom, that may manifest itself     as frequent nose bleeds, easy bruising but can also cause substantial bleeding after surgical     or dental procedures and may occur in association with pregnancy or delivery . The bleeding     tendency is usually considered to be secondary to thrombocytopenia However 50,000 platelets     are enough in healthy people to give a normal bleeding time but are associated with     significant bleeding tendencies in Gaucher patients. Bleeding tendency might be attributed by     genetic inherited or Gaucher related coagulation factors abnormalities which in some cases     stabilize with ERT. However, In other cases the etiology is an abnormality of platelet     function. This thrombocytopathy has not been delineated and apart from a few aggregation     studies, no systematic analysis has been published that convincingly shows the cause of the     disturbed function. While, experience shows that enzyme replacement (ERT, i.e: imiglucerase,     Cerezyme®) reduces this bleeding tendency, in part due to the improvement in the thrombocyte     count and elevation in coagulation factors, it is less clear what effect ERT has on the     thrombocytopathy. This has clinical significance when patients need to be prepared for     surgery or delivery or in the event of a major bleed. There is no consensus as to how     patients should be prepared or treated. Different centres use different approaches. When the     procedure is elective ERT is appropriate but in other situations DDAVP, fresh frozen plasma     and platelet infusion are possible treatments. Even activated factor VII has been used when     bleeding was not controlled. As in any other coagulation abnormality, treatment should be     tailored to the specific cause of the bleeding diathesis. The aim of this study is to define     the etiology of platelet dysfunction in Gaucher patients.      Hypothesis: The investigators expect to see a difference between platelets activation profile     among imiglucerase treated and untreated patients with at least a partial restoration of     platelets function due to treatment commencement.   "
148231|NCT01344083|"     The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine     eye drops in the topical treatment of seasonal allergic conjunctivitis.   "
148232|NCT01344070|"     Generic formulations of prescription drugs can, through their relatively lower cost, improve     healthcare as long as they maintain their registration-quality and public trust. On the other     hand, the market availability of several generic formulations raises a concern regarding     their interchangeability, despite being proven to be individually therapeutically     interchangeable with their corresponding innovator formulation.      The investigators propose to assess the quality and therapeutic interchangeability of generic     formulations in the drug market of Saudi Arabia, using fifteen, commonly-used, oral, solid,     immediate-release, and non-combinational drugs.   "
148233|NCT01344057|"     This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted Influenza     Vaccine Administered to Elderly Subjects.   "
148234|NCT01344044|"     This study aims to examine the efficacy of a brain-computer interface system for the     treatment of inattentive symptoms of Attention Deficit Hyperactivity Disorder (ADHD). The     investigators hypothesis is that children with ADHD receiving treatment with the BCI-based     training will improve to a greater extent than the control group.      Additionally, the investigators are also conducting an fMRI study involving interested     participants, to elucidate the neural mechanisms underlying any behavioural improvement. This     is necessary to help the investigators gain a better picture of brain correlates related to     ADHD and understand how the intervention can affect the brain.   "
148235|NCT01344031|"     This phase I trial studies the side effects and the best dose of MK 2206 (Akt inhibitor     MK2206) when given with anastrozole, fulvestrant, or anastrozole and fulvestrant in treating     postmenopausal women with breast cancer that has spread to other parts of the body. Estrogen     can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant     may fight breast cancer by lowering the amount of estrogen the body makes. Akt inhibitor     MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving Akt inhibitor MK2206 together with anastrozole, fulvestrant, or anastrozole     and fulvestrant may kill more tumor cells.   "
148236|NCT01344018|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that     needs to be removed. It is not yet known whether surgery is more effective with or without     radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma.      PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to     see how well it works compared with surgery alone in treating patients with previously     untreated nonmetastatic retroperitoneal soft tissue sarcoma.   "
148237|NCT01344005|"     RATIONALE: Diagnostic procedures, such as an urgent chest x-ray, may help in planning cancer     treatment. It is not yet known whether standard medical care is more effective than an urgent     x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.      PURPOSE: This randomized clinical trial is studying standard medical care to see how well it     works compared with an urgent chest x-ray in diagnosing lung cancer in smokers with chest     symptoms who are older than 60 years.   "
148238|NCT01343992|"     A comparative study to determine whether bed rest after embryo transfer (ET) affects on IVF     (In Vitro Fertilization)outcome. This study includes 240 patients undergoing IVF treatment     with donated oocytes. All the procedures of IVF, of the embryo transfer, and of the     administration of medications are performed as always and there are no variations. The only     highlighted procedure in this study is immediately after the embryo transfer. There are two     groups: one which will rest in bed for 10 minutes after the transfer and one which will not     rest after the transfer. Both procedures are common, usually depending on the habitual     clinical practice of each clinic internationally. Patients from both group receive the     routine post transfer instructions and treatment.   "
148252|NCT01343810|"     The goal of this study is to better understand the potential value of reducing stress to     ameliorate a cluster of biological and behavioral factors implicated in cardiovascular     disease (CVD) risk. These factors include psychological distress, poor sleep quality, and     exaggerated physiological responses to emotional stress. Results will be used to develop an     innovative brief intervention to reduce risk for CVD by improving sleep quality, ameliorating     psychological distress, and attenuating stress physiology.   "
148253|NCT01343797|"     The aim of the study is to determine glycemic and insulinemic index of 2 sweet syrups :     FructiLight® and fruit Fructo-oligosaccharides in sweet matrix compared to glucose.   "
148254|NCT01343784|"     The purpose of this study is to compare the incidence of catheterization from discharge to 6     weeks postoperatively when using two methods of post-operative voiding evaluation after a     mid-urethral sling procedure. The investigators' results may lead to a decreased use of     indwelling catheters and their associated morbidity after outpatient sling surgery.   "
148426|NCT01341470|"     The purpose of this study is to evaluate the safety and tolerability of single and multiple     doses of LY2495655 administered subcutaneously and intravenously in Japanese subjects.   "
148239|NCT01343979|"     This retrospective study will analyse all PCR-proven H1N1 cases from the influenza season     2009/2010 treated within the styrian LKH hospital network. For this purpose all     PCR-positive case files are reviewed in Medocs (electronic patients database) and data     regarding clinical presentation, laboratory and radiological findings, treatment, outcome and     preexisting underlying chronic illnesses will be systematically collected. In a second step     the same data collection will be performed in a group of PCR-negative patients, which were     tested during the influenza season 2009/2010 for influenza-like illness. The data from the     PCR-positive group will be compared to the data from the PCR-negative group. We expect     significant differences between the proven and unproven group regarding the primary     presentation at hospital. Based on these results a clinical score will be developed. This     score should improve H1N1 case identification in emergency departments, even if specific     diagnostic test are negative (rapid antigen testing) or still pending (PCR), reduce the     number of missed hospitalized H1N1 infection and optimize the decision making process in     emergency departments regarding which patient has to be admitted with infection control     measures and which not, and as infection control measures are expensive (face masks, gloves)     and limited (isolation room), such a score should also reduce unnecessary expense. To     evaluate the sensitivity and specificity of the score a prospective study will follow in the     influenza season 2010/2011.   "
148240|NCT01343966|"     This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to     evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's     Disease.   "
148241|NCT01343953|"     This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or     Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in     the absence of an HLA identical donor;   "
148242|NCT01343940|"     Project Dulce is designed to test a new approach to delivering family support, in the context     of the primary care medical home. The target population to be served is infants between birth     and 6 months old and their families who receive primary care at Boston Medical Center. A     dulce family partner will reach infants and families through their routine health care visits     during their first six months of life and provide them with support for unmet legal needs,     screen infants for developmental problems, screen families for mental health problems, and     improve families' knowledge of child development. The control group will receive training on     safe sleep and safe transportation for their newborn.   "
148243|NCT01343927|"     A randomized controlled trial for chronic low back pain in predominantly minority populations     with three treatment arms: yoga, physical therapy, and education. Four cohorts of     participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education). Primary     outcomes are pain intensity and measure of disability; secondary outcomes are pain medication     use, treatment adherence, and health-related quality of life.   "
148244|NCT01343914|"     This retrospective observational study will analyse demographic, clinical and     treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who     had reached >/= 9 months of progression-free survival after Avastin (bevacizumab)-based     first-line therapy. Data will be collected for approximately 9 months.   "
148245|NCT01343901|"     This observational study will evaluate the efficacy and safety of bevacizumab as first-line     treatment in participants with colorectal cancer and potentially resectable liver metastases.   "
148246|NCT01343888|"     The objective of this trial is to evaluate the efficacy and safety of two different treatment     regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care     (SOC) with PegIFN/RBV alone.   "
148247|NCT01343875|"     Background: rupture of the distal tendon in biceps muscle is a rare injury. The state of the     art treatment is surgical procedure.      Objective: Evaluation of the Surgical procedure among patients that suffered from Methods:     The investigators will review files from 2003-2010 of patients that gone through the     operation. The investigators will record pre-operation and post-operation process including     complications and rehabilitation. The investigators will invite them to the clinic for exams,     clinical questionnaires.   "
148248|NCT01343862|"     In this study of patients with moderate traumatic brain injury with frontal brain contusions     patients will be randomized to treatment with a single dose of either D-cycloserine or     placebo given 48-72 hours after injury.      Patients will undergo intensive neurocognitive testing at 3 and 6 months after injury to     assess whether treatment with a single dose of D-cycloserine improves cognitive outcome after     moderate brain injury.   "
148249|NCT01343849|"     Intend of use: A blood test for Cancer Associated Auto Antibodies (CAAA) aimed for better     diagnostic management of suspected subjects with breast pathology      Study Description: Blood is collected form patients and serum is tested for the presence of     CAAA on experimental test kit.      Objectives: To assess the effectiveness of the CAAA test.      Patient Population: The study population will include any women with suspected breast mass     detected by any conventional method, scheduled for biopsy, which will result with a     pathological verification of the suspected mass.      Target Population: The target population will be any women with suspected breast mass     detected by any conventional method, that today, is scheduled for biopsy.      Structure: Subjects that will be enrolled for the study will be checked for the presence of     CAAAb, and the results of the CAAAb test will be compared to the pathology submitted by the     physicians in the participating centers.      Sample Size: Total of 1000 samples, of which 620 samples will ensure at least 124 true     positive breast cancer subjects verified by biopsy, and 124 true negative breast cancer     subjects verified by biopsy. Additional 400 samples will be used for calibrations and     training sets.(Multi center study, statistical rationale provided below).      Primary Effectiveness Variables: The effectiveness of the test will be defined by the     specificity of the test conditionally that the sensitivity is not lower than a pre-defined     level of 95%.      Endpoint: The endpoint of this study is to show that the effectiveness is higher than 50%.      Study Sponsor: Eventus Diagnostics Ltd.      Clinical Monitor: For each site a dedicated CRO will be appointed to monitor the clinical     trials. All data will be stored in a protected internet-based database, and any changes of     the data will be traced and recorded.   "
148250|NCT01343836|"     This study is designed to compare the treatment of 2 groups in patients with Achilles     tendinopathy: autologous tenocytes injection in combination with exercises versus saline     injection in combination with exercises   "
148255|NCT01343771|"     The following randomized controlled trial will examine the effects of one year of     dehydroepiandrosterone and estrogen replacement therapy (DHEA +ERT) on bone mineral density     (BMD) and bone marrow composition in adolescents with anorexia nervosa (AN). The     investigators will use imaging techniques including dual-energy x-ray absorptiometry (DXA),     peripheral quantitative computed tomography (pQCT), visual assessments of magnetic resonance     imaging (MRI) data, MR relaxometry and magnetic resonance spectroscopy (MRS) to measure bone     mineral density and evaluate bone marrow composition. The investigators will also collect     serum to measure hormonal mediators of the changes observed in both bone density and bone     marrow composition, including adrenal and gonadal steroids, insulin-like growth factors,     growth hormone, and ghrelin, adiponectin, and leptin.   "
148256|NCT01343758|"     Infants and young children often become infected with gastroenteritis leading to vomiting and     diarrhea. This can lead to dehydration, one of the most common complaints in the Pediatric     Emergency Department. These children are often in need of treatment with intravenous (IV)     fluids. While the investigators know that IV fluids work, it is not clear which type or how     much fluid is the best amount to give. Currently, the most common type of IV fluid given is     salt water, also called normal saline.      In contrast to adults, infants and young children with dehydration often have a build up of a     certain type of acid in their blood which can perpetuate the nausea, vomiting, and general     malaise associated with gastroenteritis. The investigators feel that giving these children IV     fluids with lots of sugar (in addition to the salt) reduces the acid more rapidly than giving     just salt water alone. In a prior study, the investigators have shown that children who     receive lower amounts of sugar in the IV fluids return to the Emergency Department more often     for a second visit. Based on this study, the investigators believe that children who receive     the sugar-salt solution will do better than children who receive just normal saline.      The investigators will determine if the sugar-salt solution is better by giving equal numbers     of children the sugar-salt solution and normal saline and then see what happens to each     child. The investigators will monitor who needs to be admitted, how much each child vomits,     how much each child drinks, and also the level of acid in the blood before and after getting     the IV fluid. After the study is completed, the investigators can compare the two different     groups (children who received the sugar-salt solution versus children who received normal     saline alone) to determine if one group had greater improvement and better clinical outcome     than the other.   "
148257|NCT01343745|"     The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in     the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative     Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated     after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an     Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose     response.   "
148258|NCT01343732|"     The purpose of this study is to test whether the combination of deep transcranial magnetic     stimulation (DTMS) treatment with customary medication for obsessive compulsive disorder     (OCD) patients is effective than treatment that include only medication.   "
148259|NCT01343719|"     The objective of the current study is to investigate safety, tolerability, and     pharmacokinetics of treatment with BI 661051 rising single doses administered as oral     drinking solution (powder in bottle) in healthy male subjects.      The primary objective is to investigate the safety and tolerability of treatment with BI     661051.      The secondary objectives are (1) to evaluate the single dose pharmacokinetics of BI 661051,     (2) to explore dose proportionality, (3) to explore the relative bioavailability when BI     661051 is administered as tablet at two dose levels compared to oral drinking solution and     (4) to assess the effect on the bioavailability when BI 661051 is administered as oral     drinking solution after intake of a high fat meal.      Pharmacodynamic parameters will not be determined within this study.   "
148314|NCT01342926|"     The purpose of this study is to determine the safety and efficacy of GSK933776 in the     treatment of geographic atrophy secondary to age-related macular degeneration.   "
148260|NCT01343706|"     The primary objective of the current study is to investigate the safety and tolerability of     BI 409306 in healthy male genotyped volunteers following oral administration of single rising     doses.      The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate     release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when     administered as immediate release solid oral dosage compared to oral drinking solution and     (3) to compare the safety and pharmacokinetic profiles between two different groups of     genotyped subjects.   "
148261|NCT01343693|"     This study is being performed to document the outcomes of subjects using our MaxAn Anterior     Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for     2 years.   "
148262|NCT01343680|"     The purpose of this study is to determine whether flushing Central Venous Catheters (CVCs)     with Normal saline once per week is not inferior to flushing with 10U/ml heparin 3 times per     week, in preventing CVC occlusions.   "
148263|NCT01343667|"     The objective of this study is to provide an ongoing evaluation of clinical outcomes     associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for     embolic protection during carotid artery stenting.   "
148264|NCT01343654|"     Many drug users living with HIV demonstrate inadequate levels of medication adherence, and     are at high risk for disengaging from care. HIV positive drug users are at even higher risk     of poor medication adherence and treatment dropout when living far from treatment centers.     Rural residence is common in the U.S. South where rates of new HIV infections are     disproportionately high, especially among ethnic minorities. While there are efficacious     interventions to improve HIV treatment adherence, only a few have targeted drug users, and     these have required patients to come into research clinics for adherence interventions.     Transportation problems, poverty, isolation, and stigma are known barriers to accessing     adherence support among rural drug users with HIV.Additionally, most adherence interventions     aim to increase adherence, but come too late, unable to respond in real time to adherence     lapses to help patients re-initiate appropriate medication use while remaining in their     natural environments. There is a pressing need to develop tailored, scalable interventions     that detect nonadherence episodes in real time and enhance adherence to HIV treatment     immediately. Building interventions upon familiar, existing technology could extend their     reach into communities of non-urban patients living with HIV, overcoming common barriers to     care, and could ultimately be scaled up to help drug using HIV+ patients nationwide.      The investigators propose to develop and test the feasibility and promise of a combined HIV     adherence assessment and intervention application for rural drug users using an available,     familiar technology whose reach will grow exponentially: text messaging via mobile phones. By     2007, 84% of U.S. residents had mobile phones, with near 100% mobile phone penetration     projected by 2013. While technology adoption is often slower in under-served communities, the     trend is different with mobile phone technology. African-Americans are using more mobile     phone minutes per capita and increasing their use at a higher rate compared with other ethnic     groups. This technology has great potential to reduce health disparities. In this project,     the investigators will develop and test the feasibility and promise of a text messaging     application and system using Ecological Momentary Assessment methods to detect nonadherence     and drug use and immediately intervene to improve HIV treatment adherence in drug users     living with HIV/AIDS who reside outside major metropolitan areas. This R34 is a Stage 1b/2a     project in the Stage Model of Behavioral Therapy Development that will develop novel     interventions and methods, and generate preliminary estimates of effect sizes that will     determine whether a larger clinical trial with extended follow-up and cost-effectiveness     evaluation is warranted.      The specific aims of this project are:        1. To identify assessment and intervention features relevant to the adherence barriers and          drug use patterns of rural and non-urban HIV+ drug users using formative methods          including:             -  structured interviews and focus groups to identify specific barriers to adherence               and engagement in care and needs related to drug craving and drug use that should               be addressed by the intervention             -  iterative usability testing of components and drafts of the intervention        2. To create a text messaging mobile phone application and system (Treatment Extension by          Texting, Text) to assess and improve HIV treatment adherence and drug use in real time           --Text will be built upon a piloted unidirectional personalized text phone application          and system, STeM, and will include pre- and post-programming usability testing        3. To test the feasibility and promise of the assessment and intervention tool in a          randomized pilot trial of rural HIV+ drug users with detectable viral load (VL)          comparing Text to usual care             -  Feasibility: Identify recruitment rates, consent rates, participant flow,               completion rates, and variance of key covariates and outcome variables             -  Promise: determine point estimates and the precision of effects for primary and               secondary adherence outcomes including pharmacy refills and unannounced pill counts               (medication adherence), missed visit percentage (treatment engagement), VL, and               drug craving and drug use.   "
148265|NCT01343576|"     The aim of the study is to investigate if cow feeding regimes affects concentration of plasma     phytanic acid and risk markers of the metabolic syndrome in human.   "
148266|NCT01343563|"     This study will aim to examine the use of external trigeminal nerve stimulation (TNS) as an     adjunctive treatment for adults with major depressive disorder (MDD) when added onto     antidepressant medications. Our primary objective is the examination of two different doses     of TNS, in terms of pulse frequency.      To accomplish our specific aims, the investigators will test the following specific     hypotheses:        1. Subjects will show greater improvement in ratings of mood and other symptoms of          depression during the six-week of high frequency stimulation than during low frequency          stimulation periods.        2. Subjects will show greater improvement after 12 weeks of high frequency stimulation than          after six weeks of high frequency stimulation.        3. Subjects will show improvement in ratings of life functional capacity and quality of          life with TNS.        4. Subjects will report the TNS treatments to be acceptable in terms of side effects and          burden of using the device.        5. Subjects will show significant differences in regional brain function at the end of the          high frequency stimulation period compared with baseline, and significant differences          between high and low frequency stimulation conditions.   "
148267|NCT01343550|"     The investigators hypothesize that a creativity skills group for Borderline Personality     Disorder can reduce symptoms of BPD, depression, and anxiety.   "
148268|NCT01343537|"     Aneurysmal subarachnoid hemorrhage (bleeding on the brain due to a ruptured aneurysm) is a     serious condition with a high morbidity (incidence of having ill health) and mortality     (death). There are approximately 11 cases per 100,000 in the population per year, and     approximately 40% of these cases are fatal. (Ingall) Among the fortunate subjects who survive     the initial bleed, vasospasm and subsequent stroke are a major cause of morbidity. Vasospasm     is defined as a prolonged severe, although reversible cause of arterial narrowing that occurs     after bleeding into the subarachnoid space, most commonly after aneurysmal rupture. (Youman)     The reduced arterial diameter inhibits blood flow and deprives the brain of oxygen, which     often results in a stroke.      Vasospasm is a major problem when treating subjects with aneurysmal subarachnoid hemorrhage.     For these reasons, it is essential to diagnose cerebral vasospasm early, before permanent     deficits develop.      There may be another option to solve this dilemma. The field of neuro-monitoring     (neurological monitoring) has the technology available to continuously monitor brain activity     of these sedated ICU subjects. This may allow for early diagnosis and possibly identify     changes in neurologic function before they become symptomatic. In the past, neuro-monitoring     was primarily used in the operating room to monitor neurologic function during surgery in and     around the spinal cord. Surgery to the spine or spinal cord also carries its own form of     risk, either from mechanical trauma to the spinal cord or its nerve roots, or from     interruption of the blood supply to these structures. Should damage to nerve fibers occur,     the end result could be paralysis, loss of sensation, and onset of severe burning (i.e.     neuropathic) pain. The field of intraoperative neuro-monitoring (IOM) was developed to     address these risks during spine surgery, whereby nerves rostral (toward the head) or caudal     (toward the feet) to the site of surgery are stimulated (usually via electrical pulses) and     signals are recorded from the side opposite to the site of stimulation. Thus, the signals     carried by nerve fibers are forced to pass through the region at risk from the surgery. In     the event that changes in nerve responses are seen, the surgical team is notified, and they     can change what they're doing to try and restore signals, thereby preserving function in the     nerve fibers.      This same technology has been used in the neurosurgical ICU to monitor subjects with severe     brain injury from trauma, stroke, intracranial hemorrhage and subarachnoid hemorrhage. Using     continuous electroencephalogram (EEG) monitoring combined with somatosensory evoked     potentials (SSEPs) (a type of neuro monitoring) has been used to determine prognosis,     identify subjects in subclinical status epilepticus (state of brain being in a constant     seizure), predict elevations in the intracranial pressure Increased pressure within the     skull), and diagnose cerebral hypoxia (not enough oxygen in the brain) (Amantini)   "
148357|NCT01342367|"     The purpose of this study is see if quality of life is improved in patients receiving oral     hormone therapy compared to standard of care. The study will also compare survival rates     between patients receiving oral hormone therapy and those receiving standard of care.   "
148269|NCT01343524|"     The investigators' Upstate Cystic fibrosis (CF) Care Center is very active in research. For     example, in 2009, 68 of our 135 pediatric patients have been participating in 16 clinical     trials. Sponsors often provide their study sites with spirometers to use for PFTs. These     machines are meant to provide uniform PFTs results for studies, which include measurement of     FEV1 values. In 2009, among the 52 patients at our Center who are 6-12 years old, 20 (38%)     have been in studies with sponsor-provided spirometers. Among the 32 patients ages 13-17     years, 13 (40%) have been in studies with sponsor-provided spirometers. Anecdotally, the     investigators have noted that FEV1 results obtained during clinical trials for our patients     appear to be lower than those of our patients' usual values, especially with younger     children. The investigators hypothesize that the apparent difference in PFT results might be     related to the different incentives (if any) provided by study PFT equipment. Further, if     this difference exists, the investigators believe that this may account for the apparent     average decline in the lung function results of our patients over the recent years, given the     large proportion of our patients who participate in clinical trials. Finally, the     investigators hypothesize that younger children may be more affected by the difference in     incentives than older ones.      The purpose of this study is to collect an additional set of Pulmonary Function Tests (PFTs)     using our regular clinic equipment, on all study subjects following their study PFTs if these     are done with sponsor-provided equipment. The investigators will compare the results from     both types of machines and report regarding differences identified.   "
148270|NCT01343511|"     Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by     social interaction abnormalities, impaired verbal and non-verbal communication, and     repetitive, obsessive behavior, while the therapeutic effect of current treatments remains     limited progress .Neural hypoperfusion and immune deregulation are the two key pathologies     associated with Autism. Human umbilical cord mesenchymal stem cells (hUC-MSCs) and human cord     blood mononuclear cells (hCB-MNCs) have been shown to have the ability to modulate the immune     response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy.     In this study, the safety and efficacy of hUC-MSCs and hCB-MNCs transplantation will be     evaluated in patients with Autism.   "
148271|NCT01343498|"     This is a dose escalation trial to evaluate twice daily dosing of the sachet formulation of     BEZ235. This trial will find the maximum tolerated dose (MTD) of the sachet formulation given     twice daily, as well as evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of the twice     daily dosing. Patients will initially be given once daily dosing to determine the PK and PD     of the single daily dose. On Day 9, they will begin twice daily dosing, with half of the     single daily dose divided twice daily, and PK and PD of the twice daily dose will be     determined.   "
148272|NCT01343485|"     Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a     prospective, cluster randomized trial to determine which factors influence the acquisition of     the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to     26. This descriptive and interventional study will provide data to assess impact of a     computerized tool upon HPV vaccine series completion. The interventional aspect of this study     includes determination of patient assistance and provider support programs applicable to each     woman's situation as well as the implementation of a computer software system for customized     patient reminders.   "
148273|NCT01343472|"     This study entails an evaluation of the Washington Intensive Supervision Program (WISP). The     purpose of the evaluation is to test whether subjects assigned to WISP perform better than     those assigned to parole-as-usual (PAU).   "
171321|NCT00080353|"     This study will examine the effectiveness of treating advanced melanoma with special     tumor-fighting cells taken from the patient's blood or tumor and grown in the laboratory. The     cells are given along with infusions of a growth factor-like substance called interleukin-2     (IL-2) and an experimental vaccine called fowlpox gp100. This vaccine consists of a peptide     (part of a protein) called gp100 that is often found in melanoma tumors and chicken virus     (fowlpox) that has been altered so that it cannot produce illness in humans.      Patients 16 years of age and older with melanoma that has spread beyond the original site and     that does not respond to standard treatment may be eligible for this study. Candidates are     screened with a medical history and physical examination, chest x-ray, electrocardiogram,     blood and urine tests, and x-rays and scans to the evaluate the extent and size of the tumor.     Because the experimental preparation is based on tissue type, only patients with tissue type     HLA-A*0201 may participate. Tissue type is determined by a blood test.      Participants undergo the following procedures:        -  Leukapheresis, a procedure for collecting lymphocytes (white blood cells): Using this          procedure, special cells with good tumor-fighting ability are selected and removed for          later re-infusion into the patient. To collect the cells, blood is withdrawn through a          needle in an arm vein and directed through a catheter into a cell-separating machine.          The lymphocytes are removed and the rest of the blood is returned to the body through          the same needle. Alternatively, lymphocytes may also be collected from biopsied tumor          tissue, obtained either with a needle or by a small cut in the tumor.        -  G-CSF injections: This growth factor is injected under the skin every day for 5 days to          stimulate white blood cell production.        -  Catheter placement: Upon admission to the Clinical Center for treatment, the patient has          a catheter (plastic tube) placed in a vein in the neck or arm for giving chemotherapy          and other medicines, for infusing the lymphocytes, and for collecting blood samples.        -  Leukapheresis: Repeated in the hospital to collect and store blood that may be needed in          the rare event that the patient's blood components do not recover after chemotherapy.        -  Chemotherapy: A week before the lymphocyte infusion, patients receive a 1-hour infusion          of cyclophosphamide for 2 days and then a 15- to 30-minute infusion of fludarabine for 5          days to suppress the immune system and thereby prevent rejection of the infused          lymphocytes.        -  Vaccine and lymphocyte delivery: The vaccine is injected through the catheter, followed          by a 30-minute infusion of the lymphocytes.        -  IL-2 and G-CSF: Patients receive IL-2 infusions every 8 hours for up to 5 days after the          cell infusion to help keep the cells alive, and G-CSF injections under the skin every          day after the cell infusion until white cells increase to a sufficient number. The          entire hospital stay is usually 12 to 16 days.      About 4 weeks after the lymphocyte infusion, patients are re-admitted to the hospital for     about 10 days for a second vaccine injection and course of IL-2 infusions. Between 2 and 4     weeks after completing the full treatment regimen, patients return to NIH for evaluation.     Those whose tumors have shrunk or remained stable may repeat the entire treatment regimen two     times. Those whose tumors continued to grow may be re-treated with infusion of lymphocytes     through an artery instead of a vein if their tumors receive blood from a major artery. If     this is not feasible, or if it is tried without success, the patients will be taken off the     study.   "
148274|NCT01343459|"     Title:      HIOB - Hypofractionated Whole-Breast Irradiation preceded by Intraoperative Radiotherapy with     Electrons as anticipated Boost ISIORT- 01      HIOB is defined as hypofractionated WBRT (40,5 Gy in 2,7 Gy per fraction) preceded by an     Intraoperative Boost to the tumor bed ( 90 % reference dose of 10 Gy, 11,1 Gy Dmax IOERT).      Primary endpoint is the proof of superiority of a new treatment regimen.      The HIOB study concept is supposed to test the hypothesis whether such a combined schedule is     superior (or iso-effective) towards standard RT in terms of local control and cosmetic     outcome.      In the vast majority of all publications, annual and 5 year in-breast recurrence rates     following BCT showed a clear dependency on patient age within the following boundaries     (primary references):      Age > 50: Bartelink (standard): 0,7% (annual) 3,5% (5y) START B (best): 0,4 %(annual) 2,0%     (5y)      Age 41-50: Bartelink (standard) 1,2% (annual) 6,0% (5y) Whelan (best) 0,72%(annual) 3,6% (5y)      Age ≥ 35-40 Bartelink (standard) 2% (annual) 10% (5y) Whelan (best) 0,72% (annual) 3,6% (5y)      long these three different age groups, benchmarking will be performed against the best     published results following `Golden Standard`RT, usually defined as conventionally     fractionated WBRT with 50 Gy (25 x2) plus external tumor bed boost with 10-16 Gy electrons     (5-8x2Gy).      Superiority is defined as going below the lower limit of the estimated 5 year local     recurrence rate within the respective age group Inferiority is defined as crossing the     respective upper limit .      Secondary endpoint:      Disease free survival      Tertiary endpoint: toxicity assessment (acute and late) including long term cosmetic     evaluation      Study design and statistics:        -  Prospective multicenter single-armed        -  Sequential probability ratio test (SPRT)        -  Separate analysis within three different age groups      Estimated Accrual time: strongly dependent on recruitment per year within the respective age     group . Due to the statistical estimation of Szenario A and B the study will close after max.     Time-period of 10 years in case of A or 6,4 years in case of B..      Principal investigators and study coordinators:      UC of Radiotherapy and Radio-Oncology UC of Special Gynecology and Breast Cancer Center     Landeskrankenhaus Salzburg, Paracelsus University Clinics   "
148275|NCT01343446|"     To examine the effect of sleep impairment on coping style of patients with diabetes   "
148276|NCT01343433|"     Our purpose of this study is to determine whether bright light therapy is effective for     reducing the incidence and the duration of delirium compared to the usual treatment in     patients at the Intensive Care Unit. Our hypothesis is that bright light therapy is effective     for reducing the incidence and duration of delirium in patients at the Intensive Care Unit      Patients will be assigned to a chamber with or without bright light therapy. This assignment     is based on occupation of ICU beds and availability of nurses and is therefore independent     from patients characteristics. Patients will be included following the inclusion criterion     and exclusion criteria. Patients assigned to a chamber with bright light therapy will receive     light therapy for three hours in the morning, from eight o'clock till eleven o'clock. The     Confusion Assessment Method-score (CAM-score) and the Richmond Agitation Sedation Scale-score     (RASS-score) will be performed three times at one day by ICU nurses, this is according to the     existing routine. Besides this, an extra CAM-score and a clinical assessment will be     performed once a day by a trained non-clinician, to determine the presence of delirium. The     use of sedatives, haldol and fixation will be registered to determine the occurrence,     duration and severity of delirium. Eventually the most important outcomes will be the     clinical assessment of the patients, the CAM-score and the use of haldol. The primary outcome     of this study is the duration of delirium, defined in number of days.   "
148277|NCT01343420|"     Liquid allergen extracts contain proteins, such as (but not limited to) tree, weed, cat,     cockroach, and nuts, and are used to identify allergies by observing the body's reaction to     the introduction of extract underneath the skin. There are a few dog allergen extracts     commercially available in the US for allergy testing; however, none of these products are     standardized, meaning they are not required to be the same strength. Because some extracts     are not as potent (strong) as others, it's possible that some patients' allergies are     misdiagnosed. Typically, the most potent (strong), but safe extract should be used so that     allergic patients are correctly diagnosed.      The purpose of this study is to compare the safety and potency of an investigational (not     approved for use by the United States Food and Drug Administration [FDA]) dog allergen     extract with two commercially available dog extracts, which are of differing potencies.   "
148278|NCT01343407|"     Part I of the study will verify optimal execution of the procedures and acquisition of     satisfactory samples that will be utilized in the main study (Part II); no drug will be     administered. Part II will assess the effect of multiple doses of MK-1029 on the changes in     allergen-induced sputum eosinophils and changes in allergen-induced late asthmatic response     (LAR) when compared to placebo.   "
148279|NCT01343394|"     The objectives of this study are:        1. To see if autologous human umbilical cord blood treatment is safe for children with          acquired hearing loss, and        2. To determine if late functional outcome is improved following autologous human umbilical          cord blood treatment for children with acquired hearing loss.   "
148280|NCT01343381|"     Heparin, a blood thinner, is used routinely in Open-heart surgery. Do different brands of     this drug have differing clinical effects despite both having exactly the same regulation and     marketing specifications?   "
148281|NCT01343368|"     Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive     GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be     observed.   "
148282|NCT01343355|"     An open-label, non-randomised, uncontrolled, proof-of-concept study of patients with     HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Participants will     receive oral administration of tamibarotene in the amount of 2 mg daily over a period of 12     weeks, then 4mg daily for another 12 weeks. The patients will be followed up for further 8     weeks. Efficacy will be monitored by measuring clinical scores including motor and urination     function, HTLV-1 proviral load, immunological parameters, and markers in the spinal fluid.     Safety will be evaluated at the same time.   "
148283|NCT01343342|"     The main purpose of this study is to examine whether n-3 PUFA-induced changes in metabolic     risk factors are influenced by genetic variations within genes acting as fatty acids sensors.   "
148284|NCT01343329|"     Traumatic brain injury (TBI) is frequently associated with a hyperadrenergic state     accompanied by elevated levels of plasma catecholamines. In its more severe presentation, the     hyperadrenergic state presents as dysautonomia, which is characterized by paroxysmal     alteration in vital signs, including tachycardia. The investigators hypothesize that     intravenous (IV) esmolol is as effective at controlling heart rate in hyperadrenergic states     as oral propranolol, which is the standard of care. Our primary endpoint is efficacy of IV     esmolol vs a PRN regimen of intermittent B-blockade in controlling heart rate below a     pre-specified level (< 100 bpm) after Traumatic Brain Injury (TBI) or hemorrhagic neurologic     injury. Heart rates will be recorded continuously as well as hourly.   "
148462|NCT01341080|"     The purpose of this study is to determine if varenicline is effective in improving gait and     balance impairment in patients with Parkinson disease.   "
202451|NCT00499863|"     To assess the efficacy and safety of efficacy of MTS compared to placebo   "
148285|NCT01343316|"     The purpose of this study is to determine the benefit of feeding critically-ill patients     beyond the stomach (post-pyloric). Furthermore, because of the advent of two new post-pyloric     feeding tubes (Tiger 2 and Syncro BlueTube) designed to improve post-pyloric placement, the     investigators will be evaluating the benefits of those two tubes as well.   "
148286|NCT01343303|"     The purpose of this study is to evaluate the safety of multiple oral doses of JNJ-39439335     and to assess how JNJ-39439335 is absorbed (taken in), distributed, metabolized (broken     down), and eliminated from the body (referred to as pharmacokinetics) in osteoarthritis     patients. This study will also assess the effectiveness of JNJ-39439335 on pain.   "
148287|NCT01343290|"     The purpose of this study is to assess the effect of food on the absorption of canagliflozin     in the body when canagliflozin is taken with and without food by healthy volunteers   "
148288|NCT01343277|"     The purpose of this study is to evaluate whether overall survival for the trabectedin group     is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or     leiomyosarcoma).   "
148289|NCT01343264|"     The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is     still controversial. The selection criterion to perform either Extrapleural Pneumonectomy     (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status     of the patient, tumor stage and intraoperative findings but also on surgeons' decision and     philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against     EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment     options. The aim is to remove all gross disease and to achieve macroscopic complete     resection.      Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing     surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP     in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM     are based on retrospective analyses and their interpretation is difficult because of     inhomogeneous patient groups studied.      The aim of our study was to analyze the feasibility and results of RP as surgical therapy     modality in a standardized trimodality therapy concept.   "
148290|NCT01343251|"     The main objective of this research study was to compare the following outcomes between     patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed     catheter for dialysis access over one year: quality of life and incidence of bacteremia,     vascular interventions, hospitalizations, and death.   "
148358|NCT01342354|"     This purpose of this study is to determine the highest tolerated dose of Stereotactic Body     Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic     cancer.   "
148291|NCT01343238|"     The study will investigate whether physical exercise, or dietary restrictions, or a     combination of both, among overweight and obese postpartum women lead to a significantly     larger reduction in weight in a longer perspective, compared to similar women not receiving     the intervention. The study also will investigate the effects on body composition,     cardiovascular fitness, blood lipids, insulin levels and inflammation markers. In total, 68     women with pre-pregnancy BMI 25 - 34.9 will be randomized at 10 wk postpartum into: (1)     physical exercise, (2) dietary restrictions, (3) physical exercise + dietary restrictions and     (4) control group. The intervention lasts for 12 wk and longterm effects are measured 1 yr     after trial initiation. To date only studies showing short term (12 wk) effects exist. Our     study is the first to include four intervention groups, so that separate effects of physical     activity and dietary restriction and their interaction, can be assessed. Further, the     investigators will estimate effects on body composition taking body water into account and     estimate total energy expenditure with higher precision than previously. Overweight and     obesity is an escalating problem in Sweden. Sustainable weight reduction programs are     urgently needed. During the postpartum period, women may be motivated to lose weight.     Information aimed at promoting life style changes among overweight and obese women could in a     longer perspective be integrated in the regular maternal health care in Sweden.   "
148292|NCT01343225|"     2. Objectives        1. To determine the vitamin D status of African-American HIV patients who are HIV-treatment          naïve.        2. To compare the effects of an efavirenz-containing regimen to a protease inhibitor          regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels.        3. To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen          to a regimen that does not contain these drugs.        4. To compare the efficacy of an alternative regimen (raltegravir, darunavir, ritonavir) to          a standard once-daily regimen (tenofovir-emtricitabine-efavirenz).      Hypothesis      The investigators hypothesize that patients receiving efavirenz will be more likely to have     lower 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3levels based on the fact that efavirenz     is an inducer of CYP3A4 and CYP24 enzymes that degrade 25-hydroxyvitamin D and 1,25     dihydroxyvitamin D3, respectively, to inactive metabolites. The investigators speculate that     patients on a tenofovir-containing regimen will be more likely to have progression of bone     density loss compared to those in the non-tenofovir-containing regimen.   "
148293|NCT01343212|"     The investigators are measuring hepatocellular carcinoma(HCC)stiffness using Acoustic     Radiation Force Impulse (ARFI) technique to enhance the diagnostic accuracy for HCC     stratifications and treatment efficacy.   "
148294|NCT01343186|"     This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of     Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose     at different levels.   "
148295|NCT01343173|"     Background: Complete molecular remission under imatinib, therapeutic interruption possible     for patients in complete remission proved in different trials.      Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular     remission during two following years. The objectives of this study are to determine the rate     of patients without a molecular relapse and so the rate of molecular relapse, to determine     and to seek for clinical and biological CML-related factors predictive for a molecular     relapse after imatinib discontinuation. These objectives require to increase the number of     study patients to be enrolled for accurate statistical considerations. It will allow to     predict which patients have to be proposed for discontinuation without risk of molecular     relapse and to select the patients who need to continue or reinforce the treatment to achieve     a complete long term eradication of the disease.   "
148296|NCT01343160|"     Generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the     endoscopic and percutaneous treatment of benign biliary strictures.   "
148580|NCT01339468|"     The purpose of this study is to investigate and compare the pharmacokinetic parameters of     tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.   "
148297|NCT01343147|"     Heat therapy is frequently prescribed to patients with symptomatic knee osteoarthritis (OA).     Deep hyperthermia via localized microwave diathermy is effective in several musculoskeletal     painful conditions. However, the efficacy of superficial heating is controversial.     Furthermore, no clinical trials have yet directly compared the effects of these treatment     modalities in knee OA. Hence, the purpose of the present study is to compare the effects of     deep and superficial hyperthermia, induced via microwave diathermy and hot packs,     respectively, on pain and function in patients with symptomatic knee OA.   "
148298|NCT01343134|"     The purpose of this study is to evaluate the correlation between morphologic changes in the     outer retina and visual function after successful repair of rhegmatogenous retinal detachment     with macula off.   "
148299|NCT01343121|"     The purpose of this study is to test the hypothesis that plasma, peripheral blood mononuclear     cell and urine levels of Gemcitabine and its metabolites, 30 mins or 2 hours post infusion,     predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of     radiotherapy.   "
148300|NCT01343108|"     Emotional labor is one of the bases that organizations earn profits. Nursing care needs high     emotional labor to offer health care to patients. Among health carers that emphasize a lot on     emotional labor, nurses are especially required to include emotional labor as very important     parts of their jobs.   "
148301|NCT01343095|"     This study seeks to examine the effects of overnight noise reduction in critically ill     patients who are receiving mechanical ventilation. The investigators will randomly place     subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs     and noise-canceling headphones. The investigators will monitor for safety, and will measure     the amount of delirium experienced by subjects, record the amount of sedating and painkilling     medicines required, and measure sleep quality during the study, among other information. The     investigators will also measure noise levels experienced by patients in each group. The     investigators predict that the use of overnight noise reduction will be safe and will reduce     the amount of delirium by improving the quality of sleep in critically ill patients.   "
148302|NCT01343082|"     Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be     evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label,     multicenter study.   "
148303|NCT01343069|"     The study investigates the impact of the introduction of a surgical checklist on the     incidence of complications and mortality within 30 days after surgery in patients scheduled     for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting     longer than 20 minutes at are eligible. Surgery is performed in a single tertiary care     center. Study design is an open trial before and after intervention (implementation of the     checklist safe surgery saves lifes).   "
148304|NCT01343056|"     Patients who receive DSME (Diabetes Self Management Education) will be enrolled in a 4 arm,     randomized study with each group receiving a different method of follow up. The 4 arms will     be evaluated based on clinical indicators, goal achievement and patient satisfaction.   "
148306|NCT01343030|"     Breast implants are currently used for cosmetic breast augmentation and in breast     reconstruction following mastectomy for breast cancer. Fat grafting is a technique where fat     is injected around the periphery of a breast implant to camouflage the transition between     implant and the body. The investigators propose to show mammography images of women who have     had breast implants with fat grafting to informed and blinded radiologists and evaluate their     readings of the images.      Hypothesis: with mammographic screening, radiologists will be able to distinguish between     findings associated with fat grafting and those which are suspicious for breast cancer.   "
148307|NCT01343017|"     General anaesthesia impairs respiratory function in overweight patients. The investigators     wanted to compare arterial concentration of sevoflurane and oxygen in overweight patients     ventilated with increased tidal volume, or normal tidal volume with added 10 cm H2O PEEP.   "
148308|NCT01343004|"     The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid     hormone-related peptide, is effective in preventing fractures in postmenopausal women with     severe osteoporosis who are at risk of fractures.   "
148309|NCT01342991|"     This is a randomised trial to compare both the procedures and the difference in their     immediate postoperative pain, recovery and quality of life.   "
148310|NCT01342978|"     This research is being done to understand more about a sexually transmitted virus called     Human papillomavirus (HPV) in people with oropharyngeal cancer and their partners.   "
148311|NCT01342965|"     This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva     (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in     patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor     (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg     orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8     plus cisplatin 75 mg/m^2 iv on Day 1.   "
148312|NCT01342952|"     An open label, long term extension to Study AMB112529. All subjects may remain in the     extension study for a minimum of six months. Beyond the six month period, subjects may     continue in the extension study until one of the following conditions is met:      the subject turns 18 years of age (when the subject can receive marketed product) the product     is approved and available for use in the subject's age group, development for use in the     paediatric population is discontinued. the subject decides he/she no longer wants to     participate in the study, the investigator considers it is in the best interest of the     subject to discontinue ambrisentan (e.g. for safety reasons).      The primary objective is the long-term safety and tolerability of ambrisentan in the     paediatric PAH population. Secondary objectives are all cause mortality and change from     baseline in Study AMB112529 on efficacy parameters.   "
148313|NCT01342939|"     The purpose of this study is to describe the incretin effect and postprandial incretin     response in patients with MODY2 and MODY3 and a group of matched healthy subjects. In     sulphonyl urea treated subjects the purpose is also to compare the incretin effect with and     without treatment. In healthy subjects the purpose is also to investigate the incretin effect     under increased levels of endogen incretin hormones.   "
148315|NCT01342913|"     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone     Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate     50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.   "
148316|NCT01342900|"     Monitoring and optimizing tissue oxygenation (StO2) in high-risk surgery and/or high-risk     surgical patients may decrease the risk of postoperative complications.      Tissue hypoxia occurs frequently during high-risk surgery in high-risk patients. The     investigators want to see if an algorithm aimed at optimizing intraoperative tissue     oxygenation reduces perioperative complications as well as length of stay in the intensive     care unit (ICU LOS), 28-day mortality, and the duration of mechanical ventilation in these     patients.   "
148317|NCT01342887|"     This phase I/II trial studies the side effects and best dose of etoposide and mitoxantrone     hydrochloride when given together with cyclosporine and pravastatin sodium and to see how     well they work in treating patients with relapsed or refractory acute myeloid leukemia (AML).     Cyclosporine may inhibit efflux of cancer drugs out of cancer cells and may thereby improve     chemotherapy treatment for AML. Pravastatin sodium may stop the growth of cancer cells by     blocking some of the nutrients needed for cell growth. Drugs used in chemotherapy, such as     etoposide and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving cyclosporine     together with pravastatin sodium, etoposide, and mitoxantrone hydrochloride may kill more     cancer cells   "
148318|NCT01342874|"     Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus     (GDM) are unknown. New criteria are based on fasting glucose levels since the beginning of     pregnancy. Inositol, a putative second messenger of insulin, correlates with the degree of     insulin resistance. Dietary supplementation of inositol improves insulin resistance in     patients with GDM.   "
148319|NCT01342861|"     Hospital undernutrition is a common health problem [1]. As a countermeasure, French hospitals     have created a system of cross-function committees for feeding and nutrition called CLANs     [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions for improving     patient nutritional status include improving the characteristics of the food provided to     increase both protein and calorie intake in at-risk patients that do not require enteral or     parenteral nutrition. Looking at the various daily meals, the investigators considered that     breakfast following the night fast would be the easiest meal to improve .      Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition     of protein (milky food in the breakfast) Current care   "
148320|NCT01342848|"     Although successful, percutaneous coronary interventions (PCI) with stent implantation may be     hampered by periprocedural myocardial necrosis. In acute ST-elevation myocardial infarction     (STEMI), the reduction of thrombus burden through manual thrombus aspiration (TA) of an     occluded coronary artery has been documented to produce an improved myocardial perfusion rate     and significant survival advantage. To date, beyond feasibility and safety studies no     clinical benefit has been yet documented with the use of TA before stent deployment in the     setting of acute coronary syndromes (ACS) outside acute STEMI. The investigators hypothesize     that TA before stent deployment reduces the thrombus/plaque burden - as assessed by     intravascular imaging systems - in the setting of acute coronary syndromes (ACS) outside     acute STEMI.   "
148321|NCT01342835|"     The investigators hypothesize that patients anesthetized with sevoflurane have more pain,     postoperatively, than those anesthetized with propofol.   "
148322|NCT01342822|"     The PROMUS Element™ clinical trial (PLATINUM-PLUS) consists of a randomized controlled trial     (RCT) in the European Union (EU) which will enroll approximately 2980 subjects (2:1     randomization PROMUS Element™: Xience™ Prime) in a Population of consecutive, all comers in     the reimbursed indications per-country      All subjects will be screened per the protocol required inclusion/exclusion criteria.   "
148323|NCT01342809|"     The study hypothesis is that follow up from general practitioner after hospitalization for     self poisoning will decrease suicidal behaviour.   "
148324|NCT01342796|"     This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and     hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit     influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated     children aged 6 to <36 months.   "
148325|NCT01342783|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research trial is studying biomarkers in samples from young patients with soft     tissue sarcoma.   "
148326|NCT01342770|"     This pilot phase II trial studies how well pioglitazone works in treating patients with stage     IA-IIIA non-small cell lung cancer. Pioglitazone hydrochloride may slow the growth of tumor     cells and may be an effective treatment for non-small cell lung cancer.   "
148327|NCT01342757|"     This clinical trial is studying magnetic resonance spectroscopy imaging in predicting     response in patients to vorinostat and temozolomide in patients with recurrent, progressive,     or newly diagnosed glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Vorinostat may also help temozolomide work better by making     tumor cells more sensitive to the drug. Imaging procedures, such as magnetic resonance     spectroscopy imaging, may help measure the patient's response to vorinostat and temozolomide     and allow doctors to plan better treatment.   "
148328|NCT01342744|"     The purpose of this study is to determine the effects of metformin on cardiovascular risk     factors in postmenopausal women with metabolic syndrome.   "
148340|NCT01342588|"     The purpose of this study is to establish the accuracy of pedicle positioning using     continuous electrical pulse during screwing. Additionally, the investigators evaluate if this     maneuver can prevent neurological injury during track creation and screwing in lumbar and     thoracic spine instrumentation surgery   "
148341|NCT01342575|"     The purpose of this study is to establish which of five different maneuvers could bring the     best trans-operatory x-ray exposure during anterior cervical surgeries with the higher     security   "
149109|NCT01332383|"     To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on     Japanese patients with migraine headache in clinical setting   "
148329|NCT01342731|"     30 adult hospitalized patients who have infections due to MDR Acinetobacter baumannii will be     enrolled. The eligible patients will receive 100 mg of tigecycline intravenous infusion for     30 minutes followed by 50 mg every 12 hours for 7 to 14 days. Clinical outcomes on     effectiveness and safety will be evaluated on daily basis up to 28 days. Follow-up culture of     clinical specimen from the site of infection will be obtained on day 3 and at the end of     tigecycline therapy. Clinical response is classified as cure, improvement, failure, relapse,     death. Microbiological outcome is assessed at the end of treatment and classified as     eradication, persistence, colonization, and superinfection. Adverse events, overall 28-day     mortality and infection-related mortality will be determined. Length of stay will also be     determined.   "
148330|NCT01342718|"     The aims of this study are to investigate the effect of famous herbal formula extract and     probiotics on irritable bowel syndrome with diarrhea, and to determine whether these two     experimental items affect intestinal permeability and the composition of intestinal     microbiota.   "
148331|NCT01342705|"     The main objective of the study is to assess in patients with compensated alcoholic cirrhosis     and hepatic iron overload (HIO), as assessed by MRI, the effect of phlebotomy in order to     lower and maintain serum ferritin below 50 µg / l on the risk of hepatocellular carcinoma     (HCC) occurrence. The effect of bloodletting will be jointly evaluated on 1) episodes of     hepatic decompensation, 2) non HCC liver-related mortality 3) changes in HIO during     follow-up.   "
148332|NCT01342692|"     In order to improve the overall survival benefit observed with AZA in higher risk MDS, its     combination with other active drugs in MDS must be tested.      Among drugs that have demonstrated to be active as a single agent in MDS and have preclinical     potential additive or synergistic activity with AZA are Histone deacetylase (HDAC) inhibitors     including Valproic acid, Lenalidomide and idarubicin. Phase I studies have already been     conducted or are being conducted combining those agents to demethylating agents, showing a     low toxicity profile and significant responses in high risk MDS. In this phase II randomized     trial, we want to identify the most promising combination of Azacitidine and another drug     (among 3 drugs: Valproic acid, Lenalidomide and Idarubicin) in higher risk MDS, by comparison     to Azacitidine alone. Of note, based on efficacy and toxicity, one or several combinations     may be stopped, and others, previously tested in phase I trials, included after protocol     amendment.   "
148333|NCT01342679|"     The purpose of this study is to evaluate complete molecular response of Dasatinib in patients     for Philadelphia chromosome-positive chronic myeloid leukemia   "
148334|NCT01342666|"     -  This is a randomized, open-label, single blind, clinical trial        -  The study evaluated the effect of tomato consumption in serum HDL-cholesterol levels.        -  The hypothesis was that two daily tomatoes during one month will increase the HDL-c          levels.        -  Since a placebo of tomatoes cannot be done, the control group will receive same          proportion of cucumber because 1) it was not possible to have a tomato placebo; 2)          cucumber does not have any lycopene; 3) both can be prepared similarly; and 4) the          required quantity can be measured in the same way.        -  The intervention was during 1 month and was assigned by randomization.        -  Personnel who did the clinical and biochemical evaluation were blinded for the          intervention.        -  Lipid profile was measured before and after the intervention.        -  Confounding factors such as daily physical activity, diet, consumption of fish or          alcoholic beverages, smoking status were considered during statistical analyses.   "
148335|NCT01342653|"     Implementation of a curative strategy of treatment in peritoneal carcinomatosis of gastric     cancer. The goal is to get 1C level of evidence (patient died with standard treatment, with     this treatment some of them survive) in terms of disease free survival and overall survival.      Methodology: prospective, phase II, multicentric in Spain. Recruitment of 50 patients(to have     31 on treatment) in three years. This strategy is based on neoadjuvant systemic plus     simultaneous intraperitoneal and intravenous chemotherapy(NIPS),to treat peritoneal disease     by bi-directional approach; next step is cytoreductive surgery and HIPEC. Once patients are     discharged, they will follow a systemic adjuvant chemotherapy protocol.   "
148336|NCT01342640|"     This single arm, open label, multicenter study will evaluate the safety and change in     hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients     with chronic renal anemia who are not on dialysis. Patients will receive as a recommended     starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is     dependent on the patient's weight. Dose adjustment may be required due to inadequate or     excessive treatment response. The anticipated time on study treatment is 28 weeks.   "
148337|NCT01342627|"     Study Design This is a multicenter, open label, first line phase II study in elderly (≥ 65     years old) metastatic Renal Cell Carcinoma (mRCC) patients not suitable for any other     currently approved treatment (bevacizumab+INF, cytokines or sunitinib) except for sorafenib.      Each patient treated with sorafenib enrolled in the study will be trained to observe the     management tool for skin care. A study period of 3 years was estimated as follows: an     enrollment period of 24 months and a further follow-up period of 12 months.      Objectives of the trial Primary objective The primary aim of this trial is the evaluation of     the efficacy of a patient education program in the reduction of Hand-Foot Skin Reaction     (HFSR).      Secondary Objectives      TO assess:        -  The frequency of dose discontinuation, interruption and reduction        -  The incidence of any grade diarrhoea, and other adverse events        -  The overall Response Rate according to the RECIST criteria.        -  Progression free survival (PFR) in study population and comparison of PFS between age          sub groups in the current study population   "
148338|NCT01342614|"     The objective of this study is to investigate the effect of metformin on the correlation     between hyperinsulinemia and hypertension.   "
148339|NCT01342601|"     Ectoin acts on membranes by forming an Ectoin-Hydro-Complex therewith providing a protection     against external agents like aeroallergens. The effects of Ectoin containing nasal spray and     eye drops have already been demonstrated in several studies with adult Seasonal Allergic     Rhinitis (SAR) patients and it was shown that they can effectively reduce symptoms of     allergic rhinitis without resulting in any significant adverse events.      The aim of this clinical investigation is to demonstrate the safety, tolerability and     efficacy of Ectoin Nasal Spray and Ectoin Eye Drops in pediatric and adolescent SAR patients.     It is assumed that Ectoin containing products show an excellent safety profile and very good     tolerability together with a potent efficacy in the treatment of SAR.   "
148342|NCT01342562|"     Spinal block is the most common anesthetic technique for transurethral resection of     prostatectomy (TURP). Most patients undergoing TURP are elderly and frequently present with     cardiopulmonary and endocrine diseases. Low-dose local anesthetic is commonly administer to     limit the block level to minimize the hemodynamic changes. However, sometimes it may not     provide an adequate level of sensory block. Thus, intrathecal additive is frequently     administer with local anesthetic to improve analgesic effect.      Dexmedetomidine(DXM), a selective 2-adrenoreceptor agonist, has been used in the epidural     space in humans without any reports of neurological deficits. Previous clinical studies     showed that intravenous dexmedetomidine administration prolonged the sensory and motor blocks     of bupivacaine spinal analgesia. But clinical studies about the use of intrathecal DXM with     local anesthesia in humans are scarce in the literature. Kanazi et al. found that 3μg DXM     added to 12 mg spinal bupivacaine produced the significant short onset of sensory and motor     block as well as significantly longer duration of sensory and motor block than bupivacaine.     And Al-Mustafa et al. reported that intrathecal dexmedetomidine as an adjuvant to 12.5mg     bupivacaine in spinal anesthesia has a dose dependant effect on the onset and regression of     sensory and motor block.      In our previous study, low-dose diluted bupivacaine 5 mg provided sufficient anesthetic level     when opioid was added with local anesthetic. However, opioid-induced side effects, such as     pruritus, nausea, or vomiting, could be an obstacle in common use. The aim of this study is     to evaluate whether DXM-low-dose bupivacaine spinal anesthesia can provide the effective     spinal anesthesia and postoperative analgesia with minimal side effect compare to the local     anesthetic only group.      This study was conducted in a randomized, double-blind, controlled fashion. Patients were     randomly allocated to DXM group or Saline group. DMT group received hyperbaric bupivacaine     0.5% (1.2 ml) (6 mg) in dextrose 8% solution + DMT 0.3 ml (3 µg)－in total, bupivacaine 0.4%     (1.5 ml) intrathecally and Saline group received hyperbaric bupivacaine 0.5% (1.2 ml) (6 mg)     in dextrose 8% solution + normal saline 0.3 ml －in total, bupivacaine 0.4% (1.5 ml)     intrathecally. After spinal block, the level of sensory block, defined as the dermatomal     segment with loss of pain sensation to pin-prick with a 22 G hypodermic needle and cold     sensation to alcohol swab was measured every 2 min after intrathecal injection. The     investigators recorded the peak sensory block level, time to peak block level from     intrathecal injection, blood pressure and heart rate, and analgesic supplementation during     operation. The maximum motor block level was assessed according to the modified Bromage     scale. During postoperative period, the frequency of analgesic requirement, time to the first     analgesic request, and pain scores were evaluated by blind investigator.   "
148343|NCT01342549|"     The purpose of this research study is to understand the effectiveness of valproate (a common     mood stabilizer) to further reduce alcohol misuse when given in addition to attending an     alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main     goal of this project is to understand if people receiving valproate will have a better     recovery than people receiving the standard treatment for alcohol dependence: naltrexone.   "
148359|NCT01342341|"     The overall goals of this study are to (1) expand knowledge about interactions of     chlorzoxazone with alcohol by assessing the effects of chlorzoxazone compared to placebo in     moderate and heavy social alcohol users and (2) to compare the effects of chlorzoxazone on     visual cue induced alcohol craving to placebo in moderate to heavy social alcohol users.   "
148496|NCT01340638|"     The working hypothesis in this study is that the supraglottic device COOKGAS provides seal     pressure as well or better than LMAc ™ when adult patients undergoing outpatient surgery, are     sommeted to both interventions.   "
148344|NCT01342536|"     Primary Aim 1: Examine effectiveness of the Oh Happy Day Class (OHDC) compared to the Coping     With Depression (CWD)in increasing retention, adherence, engagement, satisfaction, and     treatment-seeking. The investigators hypothesize the OHDC compared to the CWD will result in     greater increases in: 1a. retention, 1b. adherence, 1c. engagement, and 1d. satisfaction at     the middle and end of the intervention, and 2.e. greater increase in treatment-seeking 3-,     6-, 9-, and 12- months post-intervention. Outcome measures: logs: attendance, homework     completion, class-participation level; Client Satisfaction Inventory; and Cornell Service     Index. Primary Aim 2: Examine effectiveness of the OHDC in reducing symptoms of depression at     the middle and immediate end of the intervention, and 3-, 6-, 9-, and 12- months     post-intervention. The investigators hypothesize the OHDC will result in greater reduction in     depressive symptoms compared to the CWD at 3-months post-intervention. Outcome measures:     Center for Epidemiologic Studies Depression Scale and Quick Inventory of Depression Symptoms.     Secondary Aim 3: Examine the effectiveness of the OHDC in improving self-reports of mental     and physical health status and reducing self-reports of perceived disability. The     investigators hypothesize the OHDC compared to the CWD will result in greater self-report of:     3a. improved mental and physical health status, and 3b. reduced self-report of disability at     the immediate end of the intervention and 3-,6-, 9-, 12- months post-intervention. Outcome     measures: SF-12 Health Survey, and World Health Organization Disability Assessment Schedule.      Public Health Impact: Based on CAI research, the OHDC has the potential to be four times more     effective than the CWD. If our hypotheses are proven, the OHDC will be the first     evidence-based culturally adapted depression intervention designed specifically for African     American men and women between the ages of 30-60.   "
148345|NCT01342523|"     This is an evaluative study of three National Cancer Institute (NCI) smoking cessation     resources: specifically, the smokefree.gov and women smokefree.gov websites, and the CIS     counseling phone calls. The following are the identified critical questions: (1). How     effective is each of the tobacco interventions (websites [smokefree.gov & women     smokefree.gov], NCI's Cessation Quitline counseling services operated by the Cancer     Information Service (CIS) (2). How do they compare with alternative intervention strategies?     (3). Which types of interventions appear to work best together (due to additive or     interactive effects)? (4). How do these interventions work? (5). How much are these     interventions used, and what are their relative use rates? (6). Are there important     differences in effectiveness or use rates as a function of gender, SES, or other important     person factors? We believe that the research study will address all of these questions, as     well as some less central ones.   "
148346|NCT01342510|"     Since the introduction of propofol into routine anesthesia practice, the phenomena of pain on     injection has plagued anesthesia providers. Propofol, an unstable phenol, triggers the     release of bradykinin on injection. This release causes a painful burning sensation in the     patient at the site of injection. Anesthesia providers have attempted a large number of     remedies to prevent this pain on injection. Previously explored ideas include injecting     propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment     with numerous other medications. Currently, pretreatment with lidocaine is commonly     administered to prevent propofol injection pain. No studies to date have looked at the     combination of lidocaine and magnesium in a single syringe for the pretreatment of pain on     injection caused by propofol. In addition, the administration protocols that have been     studied thus far do not mirror clinical practice at the University of Wisconsin. The     investigators propose studying the use of magnesium and lidocaine in a single syringe for     pretreatment of propofol related pain on injection.   "
148347|NCT01342497|"     The aim of this Clinical Proof of Principle study is to evaluate the effect of BBR-012 on the     healing of complicated diabetic foot ulcers.   "
148348|NCT01342484|"     The main objective of this study is to identify the dose of linagliptin in paediatric     patients.      Other efficacy objectives include the comparison of the lowering effect of linagliptin low     dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of     treatment.      Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD)     and the PK/PD relationship of linagliptin in the paediatric population.   "
148349|NCT01342471|"     Physical inactivity is a major public health problem and a primary contributing factor to the     obesity epidemic. While most Americans do not meet the physical activity (PA) guidelines (30     min/day, 5 day/wk), they do report watching several hours of TV each day, and frequently site     lack of time as a barrier for engaging in PA. The Physical Activity and Leisure-time Study     examines an approach convert sedentary TV watching into active TV watching time by having     adults step in place during commercials (TV commercial stepping).   "
148350|NCT01342458|"     The purpose of this study is to determine whether inexpensive, flexible and non-heeled     footwear is effective in improving of clinical, functional and gait biomechanics in elderly     women with knee osteoarthritis.   "
148463|NCT01341067|"     The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has on     subjects with type 2 diabetes. It is anticipated that patients using the device will obtain     tighter control of their blood sugars resulting in measureable health benefits and improved     confidence in their ability to manage their diabetes.   "
148351|NCT01342445|"     The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a     prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college     students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students     with ADHD from two universities (University of Rhode Island and Lehigh University) completed     a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral,     psychosocial, and academic functioning were completed on a weekly basis across five     conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).   "
148352|NCT01342432|"     The purpose of this study is to compare the effects of a balance reeducation protocol and an     evidenced based protocol on pain, function and postural control of low back pain patients.   "
148353|NCT01342419|"     This single-center, investigator-masked, crossover study is designed to investigate the     circadian rhythms of aqueous humor dynamics in human subjects with ocular hypertension (OHT)     before and after intervention with a commonly used ocular hypotensive medication,     brimonidine.   "
148354|NCT01342406|"     This study will compare aqueous humor dynamics in adults with primary open angle glaucoma     that receive Selective Laser Trabeculoplasty (SLT).   "
148355|NCT01342393|"     Proof of concept study is to compare the best corrected visual acuity obtained via     First-Sight lenses with the clinical gold standard of manifest refraction and     autorefraction.   "
148356|NCT01342380|"     Obtain phenotypic data and a DNA/blood sample from mood disorder patients undergoing     pioglitazone or quetiapine XR treatment as a part of an IRB approved clinical trial conducted     at the Mood Disorders Program. Pioglitazone treatment is examined in metabolic syndrome     comorbid with bipolar depression (IRB # 07-08-24) and unipolar depression (IRB # 07-07-20).     Quetiapine XR treatment is examined in generalized anxiety disorder comorbid with bipolar     depression (IRB # 10-06-19) and unipolar depression (IRB # 12-01-29). Please refer to the     respective IRB protocols for more information.   "
148360|NCT01342328|"     Cognitive dysfunction, either alone or as an element in the syndrome of delirium, is a common     occurrence with an incidence as high as 75% in intensive care unit (ICU) patients and can     independently result in serious consequences including higher mortality rate. Delirium     develops through a complex interaction between the patient's baseline vulnerability (risk     factors) and precipitating factors such as disruption of sleep that may occur during     hospitalization. While sedative-hypnotic agents that are used to facilitate hypnosis and the     management of mechanically ventilated patients converge on the neural substrate that mediate     endogenous sleep, they do so at different juncture points depending on its molecular     mechanism of hypnotic action. Hypnotic agents that modulate the GABAA receptor converge at     the level of the hypothalamus while α2 adrenergic agonists converge on sleep pathways within     the brainstem. This translational project seeks to determine whether sedation mediated by     activation of α2 adrenoceptors (dexmedetomidine) is more like natural sleep than that     provided by a sedative agent that modulates the GABAA receptor (propofol). The investigators     will examine volunteers who will be monitored continuously by electroencephalography (EEG)     and whole-brain functional connectivity by magnetoencephalography (MEG) during each of three     sleep stages, namely, that induced by dexmedetomidine, propofol, or saline (natural sleep,     control). The two drug-induced sleep regimens will be compared to natural sleep using EEG and     brain connectivity by MEG   "
148361|NCT01342315|"     To determine if a topical antifungal cream is safe and effective for the treatment of tinea     cruris   "
148362|NCT01342302|"     Breast cancer is distressing for couples in general but even more so when the illness strikes     at a relatively young age. In addition to common relationship challenges, younger couples     have to contend with the loss or disruption of age-appropriate goals for themselves.     Presently, there are virtually no resources designed specifically to assist young couples     coping with breast cancer. The purpose of this study is to develop and evaluate an online     educational program geared to the unique needs and demanding schedules of young couples. The     purpose of the program is to improve couples' relationships and mutual coping. Seventeen     couples will take part in the 7-week program. They will complete questionnaires before and     after participating to evaluate the program's helpfulness. This study will allow for the     creation of a user-friendly, cost-effective tool that could help to improve the lives of all     young couples coping with breast cancer in the years to come.   "
148363|NCT01342289|"     This research is being done to learn more about nonmyeloablative bone marrow transplantation     (BMT), also known as a mini transplant for patients with blood cancers, using bone marrow     from a relative.   "
148378|NCT01342094|"     DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol     ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary     open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized,     double-masked, parallel-group comparison study. Safety will be compared and evaluated as     well.   "
148379|NCT01342081|"     DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost     0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and     Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure) -lowering     effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter,     randomized, double-masked, parallel-group comparison study. Safety will be compared and     evaluated as well.   "
148464|NCT01341054|"     To determine the Chamomilla recutita solution dose needed to reduce the intensity and     evolution time of oral mucositis in adult subjects submitted to HSCT.   "
168572|NCT00034944|"     A clinical study to determine the efficacy and safety of MK0869 in the treatment of     depression.   "
148364|NCT01342276|"     Several studies have indicated that heart failure (HF) clinics facilitating patient     self-management and using multi-disciplinary care reduce in hospital bed-days, all-cause and     HF-related hospitalizations, all-cause mortality, and improve patient quality of life.     Additionally, national and provincial organizations have identified patient-focused homecare     initiatives in telehealth as demonstrating great promise for health service. Our pilot study     demonstrated the feasibility of the internet based vHFC and supports the investigation of     this intervention in patients with HF.      The purpose of our single-blinded randomized trail is to investigate the efficacy of an     Internet-based heart failure (HF) clinic (vHFC) in 186 patients living with HF.      Hypotheses      A. Participation in a vHFC emphasizing patient self-management and monitoring will result in     improved functional capacity compared to usual care in patients with HF.      B. Participation in a vHFC emphasizing patient self-management and monitoring will result in     improved health indices such as, self-management skills, quality of life, levels of B-type     natriuretic peptide and healthcare utilization compared to usual care in patients with HF.      Our objectives of the vHFC study is as follows:        1. To establish a cohort of 186 patients with HF.        2. To determine the benefits of participating in the vHFC over usual care at 12 months with          respect to exercise capacity.        3. To compare the changes in other risk factors and lifestyle behaviours between the vHFC          and usual care patients.   "
148365|NCT01342263|"     In 2005, more then one-third of Canadians were burdened with one or more chronic diseases.     Patients with one chronic disease often have, or are at risk for, another chronic disease.     This group of complex patients represents a substantial challenge to healthcare resources.     For patients in rural communities, the opportunity to attend ambulatory care clinics is not     always an option. Additionally, the opportunity for rural patients to receive quality care     close to, or within their homes, is of great benefit as it reduces the need for extensive     travel and the potential burden of clinical visits. The use of telehealth has been identified     as an effective modality for chronic disease management and is actively promoted by national     organizations as having great promise for health service delivery in rural areas. The     Internet as a mode for healthcare delivery has numerous advantages: 1. it is ubiquitous with     increasing access in all age groups, 2. it is inexpensive, 3. it facilitates both patient     data transfer and patient feedback, thereby supporting patient self-management, 4. it is     scalable to large patient volumes, 5. it delivers health care directly to the patient and 6.     it requires minimal set-up for patients with current Internet access.      The investigators propose to develop and evaluate a multi-chronic disease management program     delivered through the Internet (with telephone supports) focused on high-impact chronic     diseases targeted to patients in rural communities.      This study will consist of a single-blinded randomized controlled trial to investigate the     efficacy of the iCDM in 318 patients with two or more of the target chronic diseases living     in rural areas. Within this Aim, the investigators will be able to address the following     research questions:      Q1. What is the effect of iCDM on healthcare utilization and patient self-management     outcomes? Q2. What is the long-term compliance to the iCDM? Q3. What is the level of patient     and provider satisfaction?   "
148396|NCT01341860|"     A single-nucleotide polymorphism (SNP) analysis of DNA obtained from peripheral blood of the     obese patients and the normal control will be performed to find genetic marker for obesity   "
148397|NCT01341847|"     Aim of the Study :      This study will compare the colonoscopy examination between the air method (air insufflation)     and water method (water infusion) in unsedated patients with indication (symptoms and signs     based) of colonoscopy examination. This study is based on earlier study which showed that     water method had better results in reducing abdominal pain, caecal intubation and patients     willingness to repeat colonoscopy examination than air method.      Background:      Colonoscopy examination is an important method to examine and establish the diagnosis of     various diseases in the colon. Colonoscopy is successful when the tip of the scope reach the     cecum and observe the caecal valve and/ or appendix orifice. This examination can be     performed unsedated or under sedation (conscious sedation or deep sedation/general     anaesthesia). The main disadvantage of unsedated colonoscopy method is the abdominal     discomfort or pain during examination that may make patient distress and hemodynamically     unstable and possibly stoppage of the examination before reach the cecum, but the severity of     abdominal symptoms is vary from patient to patient. Many efforts have been tried to reduce     the abdominal discomfort during examination. This unsedated method with air insufflation is     our hospital standard method for colonoscopy examination since early 1980s, and less than 1%     of patients were colonoscopied with conscious or deep sedation. Our study showed the success     rate of this standard unsedated method was about 82%. The advantage of this method is     inexpensive (feasible for most of people in developing country like us), patient may be     examined ambulatory without escort, may back to work as soon as the examination is finished.     Studies showed that replace the air insufflation with water infusion into colon since the     beginning of the examination increased the success rate of caecal intubation and reduced the     abdominal pain symptoms during colonoscopy examination(1). Sedation or general anaesthesia     may increase the success rate of colonoscopy examination but it is costly, and may increase     the adverse event especially in the elderly or patients with significance cardiopulmonary     problems.      Research Design and Methods:      Eligible patients in the hospital clinics or wards will be offered to follow unsedated     colonoscopy examination. The principle investigator (PI) will explain the study, the     colonoscopy procedure , the various symptoms that may be felt during examination, the     possible adverse event and medical effort to prevent it. Patient who sign the informed     consent will be included in the study.      Methods on the day of exam. Enrolled patients will be sent to the endoscopy room and     colonoscopy will be performed by the principle investigator. Patient lie on the left lateral     position with right hip and knee flexed and left leg straight. When the PI about to start the     single-handed colonoscopy examination, the blinded observer open the sealed envelops with the     code enclosed. A standard colonoscope will be inserted. Patient may be ordered to change the     position and or abdominal compression may be applied by nurse to aid the colonoscope     advancement. Oximetry, cardiac rhythm and blood pressure will be monitored during     examination. Blinding will not be performed in this study because of the feeling of water or     air effect inside the colon can be differentiated by the patient so that in our opinion it     actually can not be blinded..The control method includes usual air insufflation during     insertion and shortening maneuvers. The study method includes only water infusion (air pump     is turned off) through the colonoscope during insertion since the scope is inserted into the     anus until reach the cecum. Water will be infused as needed under endoscopist judgement     through the adaptor on biopsy channel with endoscopic washer pump. The usual air insufflation     will be used during colonoscope withdrawal to facilitate mucosal examination and perform any     other intervention, such as biopsy. Hypothesis testing: The unsedated colonoscopy with     natural temperature water infusion minimize the pain symptoms than unsedated colonoscopy with     usual air insufflation.   "
148366|NCT01342250|"     Although liver transplantation provide a option to cure patients suffering with decompensated     liver cirrhosis this condition, lack of donors, postoperative complications, especially     rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells     (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued     experimental liver failure and contributed to liver regeneration, which suggest the novel and     promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord     mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver     cirrhosis will be evaluated.   "
148367|NCT01342237|"     The investigators plan to improve event free survival rate and reduce treatment related     toxicities of pediatric patients with high risk/recurrent CNS tumors by administrating tandem     high dose chemotherapy and autologous stem cell rescue.   "
148368|NCT01342224|"     This study will add an immunotherapy component to chemotherapy and radiation treatment in     patients who have pancreatic cancer. The objective of this study is to see if the combined     treatment is safe and feasible, and if a larger study is warranted.   "
148369|NCT01342211|"     This study will investigate the effect of PF-04950615, a new investigational lipid lowering     agent, on LDL-C and other lipids.   "
148370|NCT01342198|"     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a     pregabalin controlled release tablet with and without coadministration of erythromycin and 2)     evaluate the safety and tolerability of a single dose of a pregabalin controlled release     tablet with and without coadministration of erythromycin.   "
148371|NCT01342185|"     The purpose of this study is to verify the effectiveness and safety of medical ozone therapy     system in treatment of chronic hepatitis B.   "
148372|NCT01342172|"     The primary objectives of this study are (Phase 1) to determine in subjects with unresectable     or metastatic bladder cancer who have never had chemotherapy, the dose of lenalidomide that     is well-tolerated when given in combination with gemcitabine plus cisplatin and (Phase 2) to     study this recommended dose in subjects to evaluate progression-free survival at 1 year. The     secondary objectives will be to determine the objective response rate to treatment, and the     safety of combination therapy with gemcitabine, cisplatin and lenalidomide as well as to     evaluate lenalidomide as maintenance treatment in subjects achieving objective response or     stable disease.   "
148373|NCT01342159|"     One of the most frequent complications of diabetic retinopathy is diabetic macular edema.     Recently, intravitreal bevacizumab and intravitreal triamcinolone were the most popular     therapeutic modalities. However, as the long term effects of intravitreal bevacizumab and     intravitreal triamcinolone on visual acuity and macular thickness have not been compared, it     was the purpose of the present study to compare these treatment effects   "
148374|NCT01342146|"     The purpose of the multicenter, randomized, open-label, controlled phase II study is to     determine whether pegylated recombinant human growth hormone is effective in the treatment of     children with growth hormone deficiency.   "
148375|NCT01342133|"     The purpose of this study is to evaluate sweat duct number on the plantar surface of newborn     infants using a non-invasive confocal microscopy device.   "
148376|NCT01342120|"     The purpose of this observational study is to study specific outcomes of interest in users of     quetiapine compared with all other atypical antipsychotics and specifically olanzapine and     risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts,     extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and     stroke. This retrospective cohort study is based on population-based record linkage system     (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.   "
148377|NCT01342107|"     The purpose of this study is to evaluate lens wettability of contact lenses when used with an     investigational multi-purpose disinfecting solution.   "
148380|NCT01342068|"     Thoracic Outlet Syndrome (TOS) is a condition causing numbness, tingling and weakness in     patient's upper limbs. Symptoms are due to compression and restriction of the nerves and     blood vessels (neurovascular bundle) that extend from the neck into the upper limb exerted by     a patient's various anatomical structures. Neurovascular bundle compression can result in     decreased nerve conduction and blood flow through the arteries supplying structures     downstream from the restricted site. These anatomical restrictions include tight scalene     muscles in the neck, tightened pectorialis minor muscle in the chest and extra ribs growing     from the C7 vertebra.      TOS can be diagnosed by using special tests designed to re-elicit neurovascular bundle     compression. Upon obtaining a positive test, the patient can undergo osteopathic manipulative     treatments (OMT) to change the anatomical restrictions allowing for a decrease of symptoms     and even eradication of the syndrome altogether.      Although diagnosis and treatment of TOS is common in osteopathic medicine, the effectiveness     of the diagnostic special tests and treatment has not been thoroughly investigated. This     study aims to examine the effectiveness of the special tests (Adson's, Wright's     hyperabduction and Halstead maneuver) in diagnosing a change in blood flow through the     arteries of the upper arm compared to evaluation with Doppler ultrasound to measure blood     flow while the tests are performed. Patients with positive tests will be treated with OMT     including myofascial release, soft tissue, and articulation to relieve restricting     structures. Upon completion of treatment, the special tests will be performed again along     with the Doppler ultrasound to measure blood flow through blood vessels. Results then are     analyzed statistically for significance of the ability correctly diagnose and treat TOS     symptoms.      Results from this study will contribute towards the validity of teaching special tests in     osteopathic medical schools and allow for a non-invasive treatment protocol for patients with     TOS.   "
148381|NCT01342055|"     A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and     Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.   "
148382|NCT01342042|"     This research is randomized, controlled trial. 36 Chinese subjects with Type 2 Diabetes     Mellitus will take part in the trial.      Subjects will randomly enter into one of three groups, administration daily twice, the period     of is 84 days treatment. Subjects should be in hospital for pharmacokinetic studies in 1 d~     8d, 30 d (if necessary)and 84 d, during 9 d ~ 83 d outpatient follow-up.   "
148383|NCT01342029|"     This research study is designed to test the use of ranolazine in patients with angina (chest     discomfort due to reduced blood supply to the heart) due to microvascular coronary     dysfunction (MCD; abnormalities in the small blood vessels of the heart). This drug is     approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina. The     FDA has approved this drug based on studies primarily on patients with chronic angina with     major blockages of the arteries.   "
148384|NCT01342016|"     The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with     leflunomide tablets in the treatment of lupus nephritis.   "
148414|NCT01341626|"     This study is a young adult follow-up of 166 females who originally participated in an RCT     during adolescence due to their involvement in the juvenile justice system.   "
148385|NCT01342003|"     Sustained virological response (SVR) to antiviral therapy in patients with chronic hepatitis     C genotype 1 according to subtype (1a vs.1b) has not been extensively investigated. This     observational study was carried out on a large group of naïve HCV patients to evaluate     difference, if any, between HCV genotype 1 subtype 1a and 1b on the response to treatment     with peginterferon (Peg-IFN) plus ribavirin.   "
148386|NCT01341990|"     The purpose of the study is to evaluate the effect of an investigational multi-purpose     disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of     silicone hydrogel contact lenses.   "
148387|NCT01341977|"     The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone     hydrogel and soft hydrogel contact lens wearers.   "
148388|NCT01341964|"     Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to     prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets (sticky     cells that circulate in the blood) from forming blood clots in the arteries supplying oxygen     to the heart and in stents. The investigators hypothesize that aspirin 325mg compared with     aspirin 81 mg will increase blood levels of the active metabolite of clopidogrel in patients     with a history of coronary artery disease who receive a 600mg loading dose of clopidogrel.   "
148389|NCT01341951|"     Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis   "
148390|NCT01341938|"     This research study will determine if using a combination of 4-mg nicotine lozenges,     self-help materials, and/or telephone tobacco cessation counseling will help smokeless     tobacco users stop using tobacco. The study will consist of three interventions:        1. The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy,          phone counseling, and self help materials        2. Assisted Self-Help intervention - self-help materials and phone counseling without          lozenges        3. Lozenge Self Help intervention - self help materials and lozenge nicotine replacement          therapy.      Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the     prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at     6 months among ST users who are interested in achieving tobacco abstinence, compared to those     in the Assisted Self-Help intervention and the Lozenge Self Help intervention.   "
148391|NCT01341925|"     Childhood depression warrants treatment research; including pharmacological and     psychotherapeutic interventions. A recent study found fluoxetine to be the only medication     with empirical support for decreasing depression in children, but concerns about     treatment-emergent suicidal ideation/behavior led the FDA to mandate black-box warning for     use of antidepressants in this age group (Bridge et al, 2007). These worries have prompted     interest in alternative therapies including dietary supplements such as omega-3 fatty acids     (Ω3).      The current study compares Ω3, psychoeducational psychotherapy (PEP), and their combination     to a placebo supplement and active monitoring (AM) in a 12-week trial of 60 children with     unipolar depression. Primary goals are to determine: 1) feasibility of a) recruiting 60     participants in 24 months; b) retaining participants over a 12-week trial; and 2) effect     sizes for Ω3, PEP, and combination treatment. Secondary goals are to explore response curves     over time, mediators and moderators, treatment response across an array of outcome variables,     adherence to treatment, and side effects. This pilot study of Ω3, PEP, and combined treatment     will provide evidence about whether a larger trial is feasible and justifiable.   "
148392|NCT01341912|"     The purpose of the study is to study the long-term efficacy, safety and tolerability of     Human-cl rhFVIII in previously treated patients with severe hemophilia A.   "
148421|NCT01341535|"     The investigators hypothesize that treatment adaptation to biological and anatomical changes,     occurring during treatment, can increase the chance of cure at minimized or equal     radiation-induced toxicity in head and neck cancer patients. This trial compares standard     intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-FDG-PET/CT     scans to adaptive 18F-FDG-PET-voxel intensity based IMRT or volumetric-modulated arc therapy     (VMAT) using repetitive per-treatment planning 18F-FDG-PET/CT scans for head and neck cancer.   "
148393|NCT01341899|"     Type 1 diabetes is an autoimmune disease and results from T cell autoimmunity mediated     destruction of the majority of insulin-producing pancreatic β-cells. Hence,the development of     new therapies to control T cell autoimmunity, and to preserve the remaining β-cell function     will be of great significance in managing patients with type 1 diabetes      Autologous nonmyeloablative hematopoietic stem cell transplantation (AHST) has been tested     for the treatment of patients with new onset of type 1 diabetes. This therapeutic strategy     can result in exogenous insulin independence by destroying pathogenic memory T cells and     preserving the remaining β-cell function.      However, little is known about the efficacy of AHST in the dynamics of immunocompetent cell     reconstitution and how the reconstituted immune system regulates β-cell specific antibody     response. Furthermore, many Chinese patients at diagnosis of type 1 diabetes have progressed     to develop diabetic ketoacidosis (DKA). Whether treatment with AHST could still achieve     adequate glycemic control and preserve the β-cell function and what the factors are     associated with the therapeutic efficacy have not been explored.      This is a phase Ⅱ clinical trial in patients who have been diagnosed with type 1 diabetes     within the previous 12 months.This study is to determine:        -  The effects of autologous hematopoietic stem cell transplantation on the reconstitution          of immune system        -  β-cell preservation following stem cell transplantation        -  The potential factors affecting efficacy of stem cell transplantation        -  Whether this new therapy is safe.   "
148394|NCT01341886|"     Differentiated thyroid cancer is the most common neoplasm of endocrine system. After surgery     and radioiodine treatment, thyroid stimulating hormone (TSH) suppression is the main goal     which is achieved with levothyroxine treatment. Levothyroxine causes increased thyroid     hormones which can have negative impact on bone and cardiovascular system. Anecdotal reports     have shown that metformin can induce TSH suppression without change in T3 and T4     concentration. The purpose of this study was to prescribe metformin as additional drug to     levothyroxin in order to decrease levothyroxine dosage.   "
148395|NCT01341873|"     This randomized clinical trial studies nursing intervention in supporting family caregivers     (FCs) of patients undergoing stem cell transplant. A nursing intervention may help prepare     FCs support the recovery of the patients   "
148398|NCT01341834|"     The purpose of this study is:        1. To determine the optimal recommended phase II dose of two investigational study drugs,          LBH589 and RAD001, given in combination in all solid tumors (With enrichment for          EBV-Driven tumors).        2. To determine the pharmacokinetic profile of RAD001 in combination with two schedules of          LBH589.        3. To assess the preliminary anti-tumor activity of RAD001 and LBH589.      This study will also be exploring the hypothesis that HDACi and mTOR inhibitors abrogate the     effects of key viral proteins, and switch the virus from a latent proliferative phase to a     lytic phase. Immunologic correlates will also be examined to ascertain T-cell subpopulations     and expression of HLA class molecules. DCE-MRI will be subsequently employed in dose     expansion to examine antiangiogenic effects.   "
148399|NCT01341821|"     This study is to discuss how different personalities of leaders and employees result in the     effect of quality and efficiency in different organizational climate and also how the     leadership style of different leaders affect the organizational climate. The investigators     hope that this study will improve the key factor of quality and efficiency among leaders.     Besides, the investigators want to provide the reference of quality control for the groups of     healthcare quality in order to avoid unnecessary time and costs and achieve the goal of     improvement quality.   "
148400|NCT01341808|"     The purpose of this study is to measure the immune response in 18-40 year old IBD patients     after receiving the hepatitis A vaccine.   "
148401|NCT01341795|"     Type 2 diabetes have become a major global health problem. Currently, metformin is used as     first-line therapy in combination with lifestyle changes, and sitagliptin can be added to     metformin in case of insufficient glycemic control by metformin alone, and fixed-dose     combination of sitagliptin and metformin is available.      In clinical practice, inter-individual variations in response to sitagliptin and metformin     treatment are commonly found, which may reflect inter-patient differences in disposition of     these medications.      Sitagliptin and metformin are known as substrates of some transporters (P-gp, OAT3, OCT1 and     OCT2) and some functional variations of these transporters were reported. This study is     designed to clarify the effect of these transporter variants on response to sitagliptin and     metformin in type 2 DM patients.   "
148402|NCT01341782|"     This study is a comparison of the efficacy and safety of paricalcitol injection with     maxacalcitol injection in adult Japanese chronic kidney disease patients receiving     hemodialysis with secondary hyperparathyroidism. The main objective of this study is to     demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone     without clinically significant hypercalcemia, compared to maxacalcitol injection.   "
148403|NCT01341769|"     The purpose of this study is to assess the effects of added food ingredients, when baked into     a snack food product, on glycaemic index of the product and glycaemic and insulinemic     responses to the product in healthy adults.   "
148404|NCT01341756|"     The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which     equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to     historical controls.   "
148405|NCT01341743|"     The purpose of this study is to evaluate the efficacy and safety of generic entecavir     monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate     response to NUC therapy   "
148406|NCT01341730|"     This study is a prospective randomized clinical trial and to compare the antiinflammatory     effect of atorvastatin single therapy and atorvastatin and pioglitazone combination therapy     in carotid arteries of stable and unstable angina patients by PET/CT.   "
148407|NCT01341717|"     The purpose of the study is to determine the efficacy and safety of sitaglipin in the     treatment of Type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control using     metformin and insulin.   "
148443|NCT01341249|"     The purpose of this study is to compare and explore pharmacokinetics of zabofloxacin, the     main component of DW224aa(Test drug) and DW224a(Reference drug).   "
148408|NCT01341704|"     Hypothesis: The MSP3-LSP/Alum vaccine, administered to children will have a protective     efficacy of at least 30% (lower bound of confidence interval of 0) against malaria disease     occurring during a period beginning from 14 days after the 3rd immunization until 1 year     after.      The primary objective of this double-blind, randomized, controlled trial will be to assess     the clinical efficacy of MSP3-LSP/AlOH vaccine when administered by subcutaneous route in     children aged 12-48 months against all clinical malaria episodes occurring during a period     beginning from 14 days after the 3rd immunization until 3 months after 3rd immunization, when     administered according to the following schedule:- Primary administration: Three doses of     administered 4 weeks apart      Secondary administration (Boost): One dose 3 months after the third dose in year 1 of the     trial; and two doses, given exactly one year after the date corresponding to the third dose     and the first boost given during Year 1      Case definition for an episode of malaria is a febrile illness with axillary temperature of ≥     37.5ºC with P. falciparum parasitemia ≥ 5000 per μL   "
148409|NCT01341691|"     To determine the amount of phosphate recovered into 2 strengths of K2CG chewing gum in a     modified formulation (with or without an extender) added to the gum core, in comparison to     matching placebo gums.   "
148410|NCT01341678|"     The purpose of this study is to describe the circadian rhythm of serum and salivary     phosphorus in patients with chronic kidney disease and determine its' modification in     response to changes in dietary phosphate load.   "
148411|NCT01341665|"     The aim of this study is to evaluate the different types of osmotic dysregulation in patients     with Syndrome of Inappropriate ADH (SIADH) and, hence, to analyze the pathophysiology of     SIADH.      These types will be characterized by measurement of AVP and copeptin while performing an     osmotic stimulation with infusion of hypertonic saline.   "
148412|NCT01341652|"     The investigators are trying to find new methods to treat prostate cancer. The approach the     investigators are taking is to try to enhance patients' own immune response against the     cancer. In this study the investigators will be testing the effectiveness of a vaccine that     may be able to help the body fight prostate cancer.   "
148413|NCT01341639|"     This study will determine whether subjects who receive V419 at 2, 3, 4, and 12 months of age     have an acceptable immune response to the vaccine. The study will also determine whether the     immune response to V419 is similar to that of subjects who receive a licensed vaccine     control.   "
148415|NCT01341613|"     Background: It is becoming increasingly clear that individuals from all corners of the globe     use probiotic dietary approaches to enhance health. More recently, probiotics have shown     promise in treating a variety of disease states, due to improved strain selection, stability     and delivery technologies.      Objective: The purpose of this study is to determine the lipid lowering efficacy of a     probiotic supplement capsule containing Lactobacillus reuteri Cardioviva™, taken twice per     day over 9 weeks, in subjects with hypercholesterolemia.      Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm,     multi-centre study. The study will last a total of 13 weeks, including a 2-week wash-out     period, a 2-week run-in period and a 9 week treatment period.   "
148416|NCT01341600|"     Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and     conditions caused by blood clots. Although clopidogrel works in many individuals, some people     do not respond as well to this drug. The variation in treatment response may be linked to     genetics. This study will examine the effects of clopidogrel in a population in which     sequencing for certain genes has been performed in order to determine the role that genes     play in the response to various clopidogrel maintenance doses.   "
148417|NCT01341587|"     Currently, in the U.S., 1 in 3 males and 2 in 5 females born after 2000 are expected to     develop diabetes during his or her lifetime. Research has demonstrated that control of blood     glucose (BG) reduces the complications of diabetes. As a result, almost half of Americans     diagnosed with diabetes, are prescribed finger-stick glucose meters to monitor their BG. The     value of this approach is known to be limited by a high rate of patient non-compliance with     BG testing, where patients test less often than prescribed. Increased communication between     patient and care manager along with feedback has been shown to increase self monitoring of     blood glucose (SMBG) test compliance. However, this feedback loop is largely absent from the     current, episodic model of patient / care manager interaction and not available in existing     BG meters given to diabetic patients.      In this study, we propose to pilot test a cellular-embedded glucose meter. This device can     transmit glucose readings directly over a cellular network to a care management server and     then the patient will receive feedback on the screen of the glucose meter.   "
148418|NCT01341574|"     'Unilateral neglect' is a disorder that occurs regularly after stroke. It is caused by right-     as well as left-sided brain lesions, but more often by right-sided lesions. Patients with     this disorder neglect the contralesional side of space and/or their body. Their body axis is     often shifted ipsilesionally. A specific disorder that can appear in neglect patients is     'contraversive pushing': a postural deviation to the neglected side because the patient     pushes himself away from the ipsi- to the contralesional side.      One of the most promising neglect interventions is prism adaptation (PA): inducing an optical     shift of the visual field by means of prism glasses. This results in a modulation of brain     areas involved in neglect and in an improvement of the neglect symptoms and postural     deviation.      Research questions:        1. Which period is best suited to maximize therapeutic effects? In this respect the effects          of early and delayed PA will be compared, regarding neglect-, postural and cerebral          measures.        2. Which factors lead to a less favorable treatment outcome or to therapy resistance for          PA?        3. Will the impact of PA be larger if postural factors are taken into account in the prism          therapy?   "
148419|NCT01341561|"     The purpose of the study is to examine the relevance of biochemical markers (specific     pulmonary and cardiac markers and markers of endogenous stress) in the process of weaning in     patients with artificial ventilation.   "
148420|NCT01341548|"     The purpose of this study is to evaluate the safety and efficacy of intranasally administered     civamide nasal solution in the prevention of cluster headaches during an episodic cluster     headache period.   "
179725|NCT00196846|"     Study done in young breast cancer patients to prevent chemotherapy induced ovarian failure   "
148422|NCT01341522|"     Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance     Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to     be detrimental to pacemaker function and possibly cause harm to patients undergoing MRI     examinations. A previous study has shown that MRI is indicated in 17% of all patients with     pacemakers within 12 months of device placement , which demonstrates the need of practical,     safe approach for performing MRI on pacemaker patients. A new Reply MR-conditional pacing     system is developed by Sorin Group for safe use in the MRI environment. The new pacing system     is composed by the Reply pacemaker and the Filtrea bradycardia pacing leads. This study     intends to demonstrate the safety and the efficacy in the MRI environment of the Sorin Group     Reply MR-conditional pacing system.   "
148423|NCT01341509|"     The optimal surgical treatment for insertional Achilles tendinopathy remains unclear. The     purpose of this study is to evaluate the long-term outcome of surgical treatment by comparing     the patient reported outcomes of Insertional Achilles Tendinopathy; Achilles tendon     debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles     with flexor hallucis longus (FHL) transfer and Achilles tendon debridement, excision     calcaneal exostosis, Strayer procedure, secondary repair of Achilles without FHL transfer.   "
148424|NCT01341496|"     Background:      - A tumor cell vaccine is an experimental cancer treatment. Cancer cells are collected from a     patient and then used to develop a vaccine. The vaccine will produce an immune system     response to help destroy other cancer cells in the body. Researchers are studying ways to     improve these tumor cell vaccines. One way is to add an adjuvant. An adjuvant is a substance     that brings about a stronger immune system response. ISCOMATRIX is an adjuvant that has been     used safely in other clinical studies. But it has not been studied with certain tumor cell     vaccines. Researchers want to find out whether a tumor cell vaccine with ISCOMATRIX, given     along with cancer drug treatment, is a safe and effective way to slow or prevent tumor growth     after tumor removal surgery.      Objectives:      - To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and     drug therapy after tumor removal surgery.      Eligibility:      - People at least 18 years of age who have had tumor cell vaccines developed from cells taken     from surgically removed tumors.      Design:        -  Patients will be screened with a physical examination, medical history, blood and urine          tests, and imaging studies.        -  Patients will be treated with cyclophosphamide (once daily) and celecoxib (twice daily)          for 7 days before the first vaccine dose.        -  Patients will receive the tumor cell vaccine once a month for 6 months. They will          continue to receive drug therapy throughout the vaccine treatment. Patients will be          monitored with regular blood tests and imaging studies.        -  After the first 6 months, patients who have an immune response to the vaccine will          continue treatment with the vaccine and chemotherapy. They will also have regular blood          tests and imaging studies. They will have this treatment for up to 24 months from the          first vaccination or until they no longer have an immune response.        -  Participants will have followup visits for up to 5 years after the first vaccination, or          until the tumor returns.   "
148427|NCT01341457|"     The primary objective of this study is to evaluate the safety and tolerability of LY2603618     in combination with the standard dose of gemcitabine up to the global recommended dose of     LY2603618 in Japanese patients with solid advanced or metastatic tumors.   "
148428|NCT01341444|"     This study is being conducted to see how safe and effective the Prevena Incision Management     System Prevena is when placed over a renal transplantation incision. Prevena provides     negative pressure (suction) wound therapy. Prevena will be tested while applied during the     time each subject is hospitalized and up to 5 days after the surgery. Prevena is a small     portable negative pressure device which consists of a therapy unit that delivers negative     pressure. It also includes a dressing system that is intended for use over closed incisions     after surgery.      The intent of this study is to evaluate Prevena versus the standard care that a doctor would     use normally after a kidney transplant.   "
148429|NCT01341431|"     The purpose of this study is to evaluate the efficacy of repeated (monthly) injections of bee     venom on motor symptoms of Parkinson's disease over a period of one year, also the potential     effects of this treatment on disease progression compared to placebo (saline injections).   "
148430|NCT01341418|"     This study compares two techniques for the fixation of tibial fractures. The techniques are     the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary     nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels,     2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the     patello-femoral cartilage between patients who are randomized to receive tibial nail     insertion through either a suprapatellar nail entry portal or a standard patellar tendon     approach.   "
148431|NCT01341405|"     This is a double-blind, randomized, multicenter, phase 2b, noninferiority comparison of two     active dose levels of CG100649 vs. a standard anti-arthritic dose of celecoxib (Celebrex).   "
148432|NCT01341392|"     The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501     and amlodipine after oral administration in healthy male volunteers.   "
148433|NCT01341379|"     Hyperammonemia, which can cause brain damage, occurs in many different kinds of inborn errors     of metabolism. The investigators propose to determine if short-term (3 day) treatment with     N-carbamylglutamate can diminish hyperammonemia by enhancing ureagenesis in these patients.     The investigators propose here a short-term (3 day) trial. If it succeeds, the investigators     would consider more extensive long-term studies of the drug.   "
148457|NCT01340105|"     The purpose of this study is to compare microwave ablation using the Acculis Microwave Tissue     Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien cool-tip     radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (HCC).      The investigators hypothesize that microwave ablation can achieve a better complete ablation     rate as compared to radiofrerquency ablation.      A randomized comparative study is performed by randomly assigned participants to microwave     ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed by     the complete tumor ablation rate at 1 month, recurrence rate and survival time of     participants. Safety of the procedures is also compared between the 2 treatment arms.   "
148458|NCT01340092|"     The purpose of this study is to see whether or not Family Navigators, who 1 ) help families     after their child is diagnosed with autism and help them get autism specific services for     their child 2) help families identify barriers to obtaining these services and 3) help     families problem solve to overcome these barrier, are helpful to parents of a child newly     diagnosed with an Autism Spectrum Disorder.   "
148434|NCT01341366|"     Background:      Laparoscopic colorectal surgery has been shown by randomized trials to be associated with     better short-term clinical outcomes when compared with open surgery. However, in a     traditional perioperative care setting, the reduction in hospital stay following laparoscopic     surgery in these trials was modest. Fast-track perioperative programs have been introduced in     the West to optimize perioperative factors to reduce the physiological/psychological stress     of open colorectal surgery. However, few studies have evaluated the impact of fast-track     programs on the outcomes after laparoscopic colorectal surgery.      Objective:      To compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing     laparoscopic surgery for colorectal cancer with a traditional vs. a fast-track     perioperative program.      Design:      Prospective randomized trial.      Subjects:      One hundred and twenty-eight consecutive patients undergoing elective laparoscopic resection     of non-metastatic colonic and upper rectal cancer will be recruited.      Interventions:      Patients will be randomized to a traditional or a fast-track perioperative program.      Outcome measures:      Primary outcome: total postoperative hospital stay, including hospital stay of patients who     are readmitted within 30 days after surgery. Secondary outcomes: immunological parameters     (including systemic cytokine response and cell-mediated immune function), morbidity and     mortality, quality of life, and medical costs.   "
148435|NCT01341353|"     The mainstay of treatment for atrial fibrillation remains pharmacological;however,catheter     ablation has increasingly been used over the last decades. The relative merits of each     strategy have not been extensively studied. Our study was designed to determine if catheter     ablation is a feasible option as first-line therapy for treating patients with symptomatic     AF.   "
148436|NCT01341340|"     The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy     of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with     critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the     tibial arteries.   "
148437|NCT01341327|"     The purpose of this study is to observe clinical courses for long-term in patients with     unprotected LMCA disease and to evaluate comparative results of medical treatment, coronary     stenting with drug-eluting stents, and CABG for the treatment of an unprotected LMCA stenosis     in the real world daily practice.   "
148446|NCT01341210|"     This is a cross-sectional, observational and correlational survey study.This study is aim to     survey the the knowledge, attitudes, and decision making towards clinical trials in cancer     patients in Taiwan (R.O.C.), which attempts to invite some cancer patients who have been     experienced the treatment clinical trials' informed consent process. The research tool is a     questionnaire which includes some scale: (1)Clinical trial Knowledge scale, (2) Attitude     toward randomized clinical trials scale, (3) Shared Decision Making(SDM-Q-9),(4) Satisfaction     with Decision (SWD-scale), and (5) Decision Regret scale(DRS). The investigators expect the     research outcome can provide some instructions to improve patients' autonomy, satisfaction of     the decision making and communication process between patients and Medical professors     whenever cancer patients participating in clinical trials.   "
148438|NCT01341314|"     Research has shown that early aggressive use of medicines may stop rheumatoid arthritis     (RA)or slow its damage. The key to this is to find people with early symptoms which could be     RA and have them get a diagnosis, treatment and follow-up.      This study will recruit persons who've gone to the internet looking for information about     their symptoms. After answering a screening survey, the person with possible symptoms will be     linked to the study website for a more detailed symptom questionnaire.      After completing that questionnaire the person will receive information about the second part     of the study which includes an examination with a rheumatologist (arthritis doctor)and     laboratory tests.      Based on the joint examination and laboratory tests, the rheumatologist will tell the person     the likelihood of having RA, and make recommendations and if needed a referral for care and     treatment. Treatment is not a part of this study.      This study will also compare the information on the subject's questionnaires to the doctor's     joint examination and the laboratory tests with the hope of developing a simple inexpensive     case finding questionnaire.   "
148439|NCT01341301|"     The purpose of this research study is to examine the survival of patients undergoing     partially matched hematopoietic stem cell transplant (HSCT) on a new type of treatment     approach, which has been developed specifically for patients who have evidence of their     disease at the time of transplant. In this research study, a way of strengthening the     response of the donor cells against the disease has been developed. Patients will undergo one     additional day between the two steps of the transplant which may allow their donor's cells to     fight the disease more effectively.   "
148440|NCT01341288|"     A robotic brachytherapy device will be used to assist physicians in performing seed     implantation to the prostate. EUCLIDIAN is the first robotic system designed to allow     automatic placement of radioactive seeds by robot and thus reduce operator dependence. The     clinical study is designed to evaluate the dosimetric quality, accuracy and patient     self-reported quality of life scores after robotic brachytherapy.   "
148441|NCT01341275|"     The aims of this study are to determine:        1. the degree of immunity against hepatitis B,        2. factors associated with immunity against hepatitis B,        3. if the amount of antigen provided in a booster dose (used to measure the degree of          immune memory) affects the body's response to the booster, and        4. if the age at which the vaccination was initiated during infancy affects duration of          protection against hepatitis B among adolescents 16-19 years of age born in the United          States who were immunized against hepatitis B as infants. These data will be important          to evaluate the potential need for a possible booster dose of hepatitis B vaccine among          adolescents.      Study subjects eligible for enrollment will:        -  have blood drawn for baseline serologies        -  receive the hepatitis B booster dose (randomly determined to be either a 10 ug or 20 ug          dose)        -  have blood drawn again 14 days later to determine if the booster dose has engendered an          anamnestic response (a response attributed to prior immunity rather than a new response          to the vaccine)      The primary hypothesis is that the majority of young people will exhibit immune memory for     hepatitis B in response to a booster dose of vaccine.   "
148442|NCT01341262|"     The marked activity of thalidomide (thal) and dexamethasone (dex) in relapsed and refractory     multiple myeloma (MM) provided the basis for this phase 2 clinical study aimed at     investigating the efficacy and toxicity of thal-dex incorporated into melphalan-based double     autologous stem cell transplantation (ASCT)for patients less than 65 years old with newly     diagnosed symptomatic MM. Thal-dex was given as primary induction therapy and was then     continued throughout the subsequent treatment phases until the day before the second     autotransplantation. Primary study endpoints,as evaluated on an intention to treat basis, are     response rates to the different treatment phases (induction, first and second ASCT), best     response whenever achieved, duration of response (DOR), time to progression (TTP),     progression free survival (PFS)and toxicity profile of thal-dex. Secondary endpoints, as     evaluated on an intention to treat basis, are overall survival (OS) and clinical outcomes     (DOR, TTP, PFS and OS)according to prognostic factors, including cytogenetic abnormalities     and imaging features, as detected by 18F-FDG PET/CT.   "
148444|NCT01341236|"     This study aims at recruiting about twenty very low birth weight infants, either intrauterine     growth restricted (IUGR) or NON-IUGR      STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10     children) and NON-IUGR infants (approximately 10 children).      PRIMARY ENDPOINT:To evaluate the changes in the intestinal perfusion determined by feeding in     VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).      SECONDARY ENDPOINT:        -  To compare if changes in the intestinal perfusion induced by feeding are different          between IUGR and NON-IUGR infants;        -  To compare growth and nutritional status of the 2 groups by randomized arm.        -  To evaluate if changes of intestinal perfusion and oximetry induced by feeding are          related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of Near          Infrared Spectroscopy (NIRS). After birth, in the first 24 hours of life, and in the          transitional period, between the 48th and 72nd hours of life, all infants' intestinal          perfusion will be evaluated with NIRS and a doppler of the superior mesenteric artery          will be executed.        -  To test if changes in intestinal oximetry and perfusion can be reliable predictors of          feeding intolerance (need of interruption of enteral feeding).      DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including     20 VLBW babies. Duration of the study: 24 months.      INCLUSION CRITERIA        -  Weight at birth ranging: 700 - 1501 grams;        -  Gestational age up to 25 weeks and 6 days;        -  Written informed consent from parents or guardians      EXCLUSION CRITERIA        -  Major congenital abnormality (severe heart or cerebral disease, chromosomopathies,          severe renal malformations, any malformation or disease of the gastroenteric tract)        -  Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal,          cardiac or cerebral impairment, DIC)        -  Pre-existing cutaneous disease not allowing the placement of the probe   "
148445|NCT01341223|"     The use of amniotic membrane in ophthalmic surgery has been shown to provide an alternative     for corneal and conjunctival reconstruction in many clinically challenging situations. It has     without doubt provided an option where previously none existed in some conditions.     Nevertheless, it is has its limitations and is not universally successful for every     indication. The indications for its use are ever increasing, often on anecdotal evidence. In     some instances where it is successfully used, existing and at times simpler options are     equally effective. The collective global experience with the membrane is now vast, and the     field should now move into proper randomized controlled studies to evaluate its true     potential.   "
148497|NCT01340625|"     This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35     mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with     that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company,     Inc., following a single oral dose (2 * 0.4 mg/35 mcg chewable tablets) in healthy female     adult volunteers administered under fasting conditions.   "
148447|NCT01341197|"     Fecal occult blood test (FOBT) is a convenient tool for the screening of asymptomatic     gastrointestinal (GI) bleeding while 「guaiac-based fecal occult test (G-FOBT) 」 is     increasingly replaced by the use of an 「immunochemical-based test (I-FOBT) 」 that reacts with     human globin, a protein that is digested by upper GI enzymes and is specific for detecting     lower GI bleeding. However, in Taiwan, although the incidence of colorectal cancer is rapidly     increasing, Helicobacter pylori-related upper GI pathologies remain highly prevalent, which     may imply that mass screening solely based on I-FOBT could be insufficient as significant     upper GI pathologies can be missed. Since I-FOBT dose not predict upper GI pathologies, the     adjuncts of G-FOBT and H. pylori stool-antigen test (HpSA) may be a potential candidate to     realize a pan-detecting assay based on stool samples in a population in which both lower and     upper GI lesions are equally prevalent.   "
148448|NCT01341184|"     Evaluation of effect of rifampin or rifabutin on single dose PK of TMC207 in healthy     volunteers   "
148449|NCT01341171|"     Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.   "
148450|NCT01341158|"     The current clinical trial shall clarify the efficacy, safety and biologic effects of     neoadjuvant treatment with natural interferon-α (Multiferon) in patients with locoregional     metastases of melanoma in stage IIIB/C.   "
148451|NCT01341145|"     The goal of this study is to determine if aerobic exercise or progressive muscle relaxation     is associated with changes in cardiovascular health, brain function, and cognition.   "
148452|NCT01341132|"     This study aims to determine whether or not gadoxetate disodium (Eovist) enhanced magnetic     resonance imaging (MRI) has a higher sensitivity for detecting hepatocellular carcinoma     (Liver Cancer) comparison to multi-detector computed tomography (CT).   "
148453|NCT01340157|"     The present study is designed to assess the impact of concomitant food intake on the relative     bioavailability of a single oral fexinidazole tablet administration.   "
148454|NCT01340144|"     Analyze clinical data for a group of subjects implanted with a new surgical device designed     to reduce the incidence of patellar crepitus following PCL-substituting TKA and compare that     to a control group of subjects implanted with a TKA design known to have an incidence of     patellar crepitus of approximately 5%.   "
148455|NCT01340131|"     The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828     (Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.   "
148456|NCT01340118|"     Abnormal lung function and high exhaled nitric oxide (FeNO) have been reported in     asymptomatic patients with asthma. The investigators aimed to assess whether FeNO and     FEF25-75 improve concurrently after treatment with inhaled corticosteroid (ICS) in patients     with controlled asthma. Geometric mean (GM) FeNO and spirometric values in patients 8 to 16     years of age who maintained asthma control without controller medication were compared with     healthy controls and patients with uncontrolled asthma who were also not receiving controller     medications. Patients with controlled asthma and high FeNO (> 25 ppb) were randomized to ICS     treatment or to remain untreated. Changes in spirometric values and GM FeNO from baseline     were evaluated after 6 weeks.   "
148459|NCT01341119|"     To study clinical features, prognostic factors and treatment outcome and to develop a     possible prognostic index in skin/soft tissue primary NK/T cell lymphoma patients.   "
148460|NCT01341106|"     This study will examine whether 12 month treatment with entecavir(Baraclude®) has an effect     on changes of liver stiffness measurement (LSM) and of hyaluronan measurement in patients     with chronic hepatitis B infection.   "
148461|NCT01341093|"     The purpose of this study is to elaborate an educative program that includes telephone     follow-up and assess its impact on the perceived health status of patients submitted to     percutaneous coronary intervention.   "
148465|NCT01341041|"     This research is being done because the investigators are trying to examine the safety and     effectiveness of this wound cleaning liquid, CACD (chlorine dioxide). The investigators are     trying to see if this liquid has the ability to decrease infection rates and decrease the     scarring effects from the healing process. In animal studies, CACD has been shown to decrease     scar formation and decrease the risk of wound infections. CACD is also used for the treatment     of burns to decrease infection rates and improve wound healing. CACD is not FDA approved for     this specific use, but it is FDA and USDA approved for reducing bacterial contamination on     meat and food products for human consumption. In addition, an investigational drug (IND)     application has been submitted to the FDA for this study. The FDA has approved the use of     this solution for this study.   "
148466|NCT01341028|"     -  Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is considered a combination of          restriction-malabsorption procedure and one of the most common operative procedures          implemented.        -  Over the last years increasing evidence suggests that the beneficial effects of          bariatric operations might be related to the suppression of appetite caused by the          release of the anorectic gut hormones such as peptide-YY (PYY) and glucagon-like          peptide-1 (GLP-1)by the L cells of the distal gut and the suppression of the orexigenic          hormone ghrelin released by the stomach.Obese people have a blunted rise in PYY and          GLP-1 after a meal, possibly resulting in impaired satiety and hence greater food          intake.        -  In the present study the investigators sought to evaluate the effects of the resection          of the gastric fundus, the main source of ghrelin production, on the secretion of          ghrelin, PYY, GLP-1 and insulin and in addition on glucose levels, appetite and weight          loss, in morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass.   "
148480|NCT01340846|"     GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that     is being developed for the treatment of BRAF mutation-positive tumors. This is a 4-part study     (in 4 separate cohorts of subjects) designed to examine the interaction potential of     GSK2118436, either as a perpetrator (i.e., effect of GSK2118436 on warfarin; Part A) or     victim (i.e., effect of other drugs on GSK2118436; Part B: ketoconazole and Part C:     gemfibrozil), as well as to evaluate the single and repeat dose pharmacokinetic parameters of     GSK2118436 (Part D). A sufficient number of subjects will be screened to obtain approximately     12 evaluable subjects each for Part A, Part B, Part C and Part D. Following completion of     this study, subjects may continue dosing with GSK2118436 in the roll-over study, Protocol     BRF114144.   "
148467|NCT01341015|"     Objectives:      A lot of children who injure their ankles come to the emergency department for an evaluation,     and often an X-ray of the ankle is obtained to determine if a bone fracture is present. In     more than 85% of cases, however, the injury is a sprain and not a bone fracture and can be     treated with rest, ice, elevation, and pain medications. X-rays obtained in the emergency     departments are time consuming, often uncomfortable for the patient, and expose children to     radiation, the long-term effects of which are not yet fully understand by doctors or     scientists. Bedside ultrasound is a non-invasive and a non-painful device that does not     produce radiation. It was been shown to determine the presence of bone fracture in childrens'     wrists and forearms just as well as X-rays do. In our study, the investigators would like to     determine if a bedside ultrasound can also be used to evaluate ankle fractures in children.      Research Procedures:      In our study, the investigators will ask the parents and children, who are scheduled to get     an X-ray of their ankle in the emergency department, to examine their ankles with an     ultrasound machine as well. Since the bedside ultrasound is not significantly time-consuming,     does not require patients to remain still, and is readily available in the department, the     procedure will be performed while kids are waiting to get an X-ray, getting registered, or     awaiting further treatment. On the data collection form, the investigators will document the     patients' names, birthdates, medical record numbers so that their X-ray results can be     compared to the ultrasound results for the purpose of the study. The information will be     stored in a secure cabinet in a locked office. The investigators will also document which     side is injured, where the patient feels pain and what the ankle looks like to help perform     the ultrasound. The results of both the ultrasound and X-ray will be documented for each     patient.   "
148468|NCT01341002|"     The objective of this study is to estimate red blood cells (RBC) transfusion related to     central venous O2 saturation (ScvO2) measurement. This prospective, randomized trial is     performed in visceral, vascular and thoracic surgery units in the university hospital of     Lille.      One hundred patients need to be included. Inclusion criteria are: age 18 to 99 year old,     patient with central venous catheter in place and fulfilling the haemoglobin (Hb) threshold     criteria for RBC transfusion according to the XXIIIth French Consensus Conference in critical     care medicine recommendations.      After randomisation, patients will be eligible to receive RBC according to their level of Hb     in the standard group and according to the Hb and ScvO2 in the optimization group. Patients     without any disease are transfused if their Hb level is below 7g/dL; patients older than 60     years or having sepsis are transfused if their Hb level is 8g/dL or lower and cardiac     patients are transfused if their Hb level is 9g/dL or lower. In the second group, transfusion     is performed if and only if the ScvO2 level is les than 70% when Hb is under the same     threshold levels.      The primary aim of the study is to compare the number of RBC units transfused by group     (standard group or optimization group) over a period of 5 days counted from the first     decision of transfusion taken post-operative. Considering the randomisation and considering     the 50 % reduction of the decisions of transfusion in the group optimization, the absolute     blood savings is estimated 25 % for the whole population. Secondary end points include the     number of side effects associated with transfusion or when avoiding transfusion, length of     hospital stay, and hospital mortality as well as major adverse events.   "
148469|NCT01340989|"     CO2 absorption from the pneumoperitoneum increases over time during laparoscopic procedures.     Adding 4% of oxygen to the carbon dioxide was shown in rabbits to decrease CO2 resorbtion     through prevention of mesothelial hypoxia. We want to prove this concept in human and expand     it to the use of full conditioning.   "
148470|NCT01340976|"     This study will evaluate the safety LY2787106 in participants with cancer and anemia. It will     also evaluate when LY2787106 can improve anemia. This study has two parts: Part A is a dose     escalation evaluation. Part B is an evaluation of LY2787106 at a defined dose given with and     without iron supplementation.   "
148471|NCT01340963|"     The study investigated 100 subjects, both genders, with chronic Chagas disease, confirmed by     at least two distinct serological tests, and classified according to Los Andes classification     in a long term follow-up aiming at identifying the predictive value of the signal-averaged     electrocardiogram for cardiac death and ventricular tachycardia.      All subjects admitted to the study were submitted to clinical history taking, physical     examination, and noninvasive assessment, including blood pressure measurement, resting     12-lead surface electrocardiogram, 24h ambulatory electrocardiogram monitoring,     M-Mode/two-dimensional echocardiogram, signal-averaged electrocardiogram in both time and     frequency domains. Selected subjects were further submitted to treadmill stress test and     coronary angiography to rule out coronary heart disease.      Subjects were followed by non-investigational primary care assistance at three to six months     scheduled clinical visits on an outpatients basis. Both noninvasive and invasive evaluation     during follow-up were requested at discretion of primary evaluation. Adverse outcomes were     ascertained by review of medical records and active contact to either study subjects or their     relatives.   "
148472|NCT01340950|"     This primary aim of the project is to determine the association between antiretroviral     therapy that better distributes into the central nervous system and prevention of     HIV-associated neurocognitive impairment.   "
148473|NCT01340937|"     This study will determine whether three manufacturing lots of V419 (PR5I) induce similar     immune responses to all of the antigens contained in V419 when given concomitantly with     Prevnar13™ and RotaTeq™.   "
148474|NCT01340924|"     The overall objective of this research project is to study the impact of preventive practices     on the T2D-related risk profile among women with and without prior GDM and their children     exposed and unexposed to GDM.   "
148475|NCT01340911|"     The main purpose of the study is to see how safe SRT3025 (study drug) is when given at     different doses. The study will also investigate how the study drug is taken up, metabolised     (chemically broken down), distributed through the body and excreted. A further aim is to look     at how taking the study drug after eating might change this process.   "
148476|NCT01340898|"     This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK     134612 in healthy infants, when co-administered with other infant vaccines, on three     different dose schedules.   "
148477|NCT01340885|"     The purpose of this study is to determine the relationship between attention and quality of     life and how rivastigmine and atomoxetine alter attention in non-demented persons with     Parkinson's disease (PD).   "
148478|NCT01340872|"     The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation,     is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with     non-active ulcerative colitis (UC).   "
148479|NCT01340859|"     The broad objective of this research is to effectively utilize a unique window of opportunity     during the hospitalization period following a recent suicide attempt to deliver a brief and     targeted intervention for suicidal individuals.   "
148493|NCT01340677|"     The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of     canagliflozin in healthy volunteers.   "
148481|NCT01340833|"     GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that     is currently being developed for the treatment of BRAF mutation-positive tumors. This is an     open-label, non-randomized study designed to determine the absolute bioavailability of an     oral dose of 150 mg of GSK2118436 co-administered with an intravenous 50 microgram dose of     [14C]GSK2118436 in subjects with BRAF mutant solid tumors. Pharmacokinetic samples will be     obtained up to 72 hours post-dose. Safety assessments will be performed throughout the study.     After completing all assessments, eligible subjects may transition to BRF114144, an     open-label, rollover study of GSK2118436 to continue treatment.   "
148482|NCT01340820|"     The purpose of this study is to evaluate the safety and immunogenicity of AERAS-422 in     healthy, BCG-naïve adults.   "
148483|NCT01340807|"     Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are     at risk of functional decline, joint degeneration, skin breakdown and further limb loss due     to the forces placed on the contralateral limb through prosthetic ambulation. If specialized     prosthetic gait training and proper use of the appropriate prosthetic foot can decrease     forces on the intact limb, the long term health and quality of life of veterans with     amputations could be substantially improved. We will address two key questions:      Key Question 1: After receiving specialized gait training and a new prosthetic socket, will     subjects demonstrate differences in gait symmetry and external mechanical work between the     bionic and conventional prosthetic feet, while performing various functional activities.      Key Question 2: Can external mechanical work be used as a clinically friendly measure to     differentiate between prosthetic feet?   "
148484|NCT01340794|"     This phase II trial studies how well pazopanib hydrochloride works in treating patients with     advanced or progressive malignant pheochromocytoma or paraganglioma. Pazopanib hydrochloride     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and     by blocking blood flow to the tumor.   "
148485|NCT01340781|"     The prevalence of obstructive sleep apnea (OSA) in patients admitted to the hospital is     likely significantly higher than the general population as hospitalized patients carry a high     prevalence of co-morbid conditions, such as diabetes and cardiovascular diseases, that are     commonly associated with OSA. The true prevalence of OSA in hospitalized patients is not     known, though there is limited data suggesting that the rate of OSA in hospitalized patients     is indeed high. Two studies have reported on the rate of polysomnographic (PSG) diagnosis of     OSA in patients referred for OSA evaluation while in-hospital. These studies reported     frequencies of 77% (in a retrospective study of 100 patients) and 88-100% (in an     observational study of 250 patients). Similarly, 2 studies evaluated the prevalence of sleep     disordered breathing in patients admitted with acutely decompensated heart failure, finding     frequencies of sleep apnea in 97% (prospective study of 29 patients studied with PSG) and 75%     (prospective study of 395 consecutive patients studied with portable monitors). However, all     of these studies are limited by either study design (retrospective), small numbers, limited     channel portable monitoring, or evaluations of highly select patient populations.     Furthermore, none of these studies examined screening tools that may help to identify which     patients are at risk for OSA and thus might require the more extensive and expensive     objective testing.      This study will test the following hypotheses:        1. The prevalence of OSA in unselected hospitalized medical patients will be more than 50%          of the study population.           Specific Aim 1: To determine the prevalence of OSA in a group of unselected hospitalized          medical patients by a combination of sleep symptoms and PSG performed while in-hospital.        2. Screening tools will be able to accurately identify OSA in hospitalized medical          patients.      Specific Aim 2: To determine the accuracy of different screening questionnaires for the     diagnosis of OSA in hospitalized medical patients by comparing the questionnaire results to     that of a PSG performed while in-hospital.   "
148486|NCT01340768|"     This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment     versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who     regularly take an SU drug, and choose to fast during the month of Ramadan. The primary     hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or     without metformin) compared to SU treatment (with or without metformin) results in a lower     incidence of hypoglycemia in participants with T2DM.   "
148487|NCT01340755|"     Transanal Endoscopic Rectosigmoid Resection with Laparoscopic Assistance was developed at     Massachusetts General Hospital and performed successfully to remove cancer of the lower     rectum. Based on the outcomes, the research doctors believe that this investigational surgery     may be as safe and effective as standard laparoscopic or open surgery performed to remove     rectal cancer, may facilitate the operation and reduce the size of the abdominal incisions.     In this research study, the investigators are looking to see if this investigational     procedure is a safe and effective approach to remove rectal cancer of the mid and lower     rectum.   "
150274|NCT01317030|"     The objective of this study is to evaluate tears between habitual contact lens wearers and     non contact lens wearers using a Schirmer Strip for tear collection.   "
148488|NCT01340742|"     Major abdominal surgeries are associated with perioperative cardiac morbidity of up to 10%.      Ischemic preconditioning may have a protective effect. The purpose of this study is to find     out remote ischemic conditioning by inflating a blood pressure cuff on the arm will have a     protective effect.   "
148489|NCT01340729|"     The goal of this clinical research study is to find the highest tolerable dose of TPI 287     that can be given to patients with metastatic melanoma. Researchers want to find out if TPI     287 can control the disease. The safety of TPI 287 will also be studied.   "
148490|NCT01340716|"     This is a randomized Clinical Trial to assess the effects of Tai Chi Chuan on blood pressure,     respiratory muscle strength and functional capacity in patients after recent acute myocardial     infarction.   "
148491|NCT01340703|"     The purpose of this study is to evaluate the efficacy of vitrectomy, without gas tamponade or     laser photocoagulation to the margin of the optic nerve, for the treatment of macular     detachment associated with optic disc pits and to characterize retinal manifestations during     treatment of optic pit maculopathy using optical coherence tomography (OCT). Vitrectomy with     induction of a PVD at the optic disc without gas tamponade or laser photocoagulation appears     to be an effective method of managing macular detachment due to optic disc pits. OCT scanning     pre- and postoperatively suggests that peripapillary vitreous traction with the passage of     fluid into the retina through the pit is the cause of the schisis-like separation seen in     optic disc pit maculopathy.   "
148492|NCT01340690|"     This study will determine the nutritional efficacy of Polyunsaturated Fatty Acids (PUFAs) in     combination with zinc and magnesium, in children and adolescents diagnosed with Attention     Deficit/ Hyperactivity Disorder (ADHD). The nutritional efficacy has to be proven in     agreement with the German Verordnung über Diätetische Lebensmittel (DiätV) and the     corresponding European Directive 1999/21/EC. This objective is reached by performing a     placebo-controlled supplementation study with a main efficacy criterion which is also being     used in pivotal studies of stimulant and non-stimulant drugs, i.e. the treatment differences     between final visit and baseline in the Attention Deficit Hyperactivity Disorder Rating     Scale, Parent Version IV (ADHDRS-IV).   "
148498|NCT01340612|"     The STAT trial aims at comparing coiling versus coiling plus stenting in patients with     aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous     coiling or wide-necked aneurysms. The primary hypothesis is that the use of stenting in     addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared to     coiling alone.   "
148499|NCT01340599|"     This randomized pilot phase II trial studies the side effects and how well defined green tea     catechin extract works in treating patients with localized prostate cancer undergoing     surgery. Defined green tea catechin extract contains ingredients that may prevent or slow the     growth of certain cancers.   "
148500|NCT01340586|"     The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg     Apixaban in subjects with normal renal function and subjects with end stage renal disease     (ESRD) maintained with hemodialysis.   "
148501|NCT01340573|"     This is a non-interventional study designed to evaluate the efficacy and safety of     combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C     (CHC). CHC participants with confirmed positive hepatitis-C virus (HCV) RNA in plasma, and     who have not been previously treated with the Pegylated interferon (PegIntron) Pen, were     enrolled into study.   "
148502|NCT01340560|"     Objective To evaluate the effect of local injury to the endometrium for implantation,     pregnancy and live birth rates in ICSI -ET cycles with recurrent implantation failure.      Design Randomized controlled clinical study. Setting A clinical will assist reproductive     center of Selcuk University Meram Medical Faculty Hospital in the Konya, Turkey.      Population A group of 100 women, who failed to conceive during one or more cycles of IVF and     embryo transfer (ET), will treat with a long protocol for controlled ovarian     hyperstimulation.      Methods The IVF treatment and ET will precede by repeated endometrial biopsies, in a randomly     selected 50 of a total of 100 women.   "
148503|NCT01340547|"     This is an open-label study of palifosfamide-tris administered intravenously on Days 1, 2,     and 3 of a 21-day cycle to subjects with advanced solid tumors. Enrolled subjects will     receive a placebo-control infusion on Day -1 and then commence palifosfamide-tris study     treatment 24 hours later on Day 1.      Time-matched, intensive ECG monitoring will occur during and following placebo and     palifosfamide-tris infusions on Days -1, 1, 2, 3 and 8. Generation of ECG data for study     analysis will be performed in a blinded fashion at a central ECG laboratory.      Blood and urine sampling to characterize the pharmacokinetics of palifosfamide-tris will be     performed on Days 1 through 8 of Cycle 1.   "
148504|NCT01340534|"     The purpose of this study is to determine if the use of supplemental oxygen at 80% FIO2 can     reduce the incidence of surgical site infection after emergency cesarean section.   "
148505|NCT01340521|"     The goal of the study is to quantitatively evaluate pituitary hormone response, follicle     stimulating hormone (FSH) and luteinizing hormone (LH), to low doses of clomiphene citrate in     normally fertile women.   "
148506|NCT01340508|"     The hypothesis of this study is that dose escalated intensity modulated radiotherapy (IMRT)     to a dose of 55Gy in 25# to primary rectal tumor concurrent with oral capecitabine results in     an improved pathological response rate from 8% (German trial) to 25%.   "
148507|NCT01340495|"     In this study we are looking at a type of radiation called proton radiation which is known to     spare surrounding tissue and organs from radiation. The proton radiation will be delivered     using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton     Radiation Treatment). Proton radiation delivers no dose beyond the region requiring     treatment. This may reduce side effects that patients would normally experience with     conventional radiation therapy or other means of delivering proton radiation therapy. In this     study we are evaluating the effectiveness of using proton radiation delivered to reduce side     effects association with radiation treatment.   "
148508|NCT01340482|"     The primary purpose of this study is to assess the safety and efficacy of repeated     subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).     A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone     mineral density and bone quality.   "
148509|NCT01340469|"     The purpose of this study is to determine whether oral probiotic supplementation could reduce     the incidence of nosocomial infections in preterm infants.   "
148510|NCT01340456|"     The objectives of this study are:        -  To investigate if the endogenous cholesterol metabolite, 4beta-OHcholesterol could be          used as a marker for induction of cytochrome P450 (CYP) 3A4.        -  To compare 4beta-OHcholesterol with midazolam as a marker for induction of CYP3A4.   "
148511|NCT01340443|"     This observational study will evaluate the safety and efficacy of MabThera/Rituxan     (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell     lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collected from each patient during     the 6 months of induction treatment and for up to 3 years of follow-up.   "
148512|NCT01340430|"     The main purpose of this study is to confirm the high pathologic complete response rate after     neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in     Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer   "
148522|NCT01340300|"     Metformin is a medication that is commonly used in the treatment of diabetes. Recently small     studies in cancer patients without diabetes suggest that metformin may benefit in lowering     insulin levels. In those studies of patients with cancer but not diabetes, glucose (or sugar)     levels in the blood are generally no lowered. Insulin and insulin-like growth factors affect     the growth of cancer cells.      This randomized study will compare different interventions; exercise, exercise and metformin,     metformin alone, or a control arm. The investigators are not directly testing how either     exercise or metformin affects your disease. The investigators are testing how they affect     insulin levels in your body as well as other blood markers. The investigators believe that     these blood tests may either be related to cancer recurrences or be an early sign of cancer     recurrences and they are testing how both exercise and metformin may change those markers.   "
148523|NCT01340287|"     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable     low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in     midly hypercholesterolemic people not treated by statins.   "
148513|NCT01340417|"     The general goal of the present study is to examine the developmental changes caused by     melatonin in preterm and term newborns.      The major brain lesions associated with cerebral palsy and cognitive impairment in preterm     infants are periventricular white matter damage (WMD). At the present time, despite major     improvements in neonatal care, there are no established therapeutic regimens for the     treatment of brain lesions in preterms. Melatonin is secreted by the pineal gland;     melatonin's neuroprotective action has been well documented in animal experimental models.     Neuroprotection is believed to stem from its direct free radical scavenging, indirect     antioxidant activities.      Originality Several reports have described melatonin secretion in older children, but only a     few have observed melatonin concentrations during the first year of life. Very little is     known about the fetal pineal melatonin synthesis and nothing at what prenatal age melatonin     synthesis starts. Premature infants have a 3 months delay in the development of melatonin     rhythmicity compared to full-term infants. One study found discordant data with decreasing     melatonin value around term. The absence of longitudinal study and the low number of children     included make the interpretation difficult of the secretion of melatonin at the newborn.      Hypothesis: Infants born before 28 weeks gestation have melatonin deficiency (50pg/ml),     compared to newborns at term (100pg/ml).      Study design: prospective, longitudinal, multicenter trial in 3 Neonatal Intensive Care Units     in Ile de France. Specific aim is to compare the developmental changes of melatonin in     preterm and term newborns (200 infants and their mothers: 4 groups of 50 infants: 24-27GA +6d     ; 28-32 GA +6d ; 33-36 GA +6d ; 37-41 GA +6d). Secondary aims are the following:        -  determine Melatonin creatinin excretion in preterm infants        -  correlate between serum melatonin secretion and urinary melatonin and          6-sulfatoxymelatonin excretion        -  determine endogenous melatonin production in the human pineal        -  correlate genetic variations between different levels of melatonin in premature infants        -  assess clinical and neurological outcomes at term Clinical impact The present clinical          project is part of a translational approach, expected data for infants born before 28          weeks gestation is melatonin deficiency which should participate in determining the          potential use of melatonin as a neuroprotectant in human preterm neonates.   "
148514|NCT01340404|"     The aim of this study is to demonstrate that cerebral velocities assessed by transcranial     doppler (TCD) are more significantly decreased by SCT than by long-term transfusion program A     multicenter, national, non-randomized, prospective study of paired cohort will be conducted,     with 2 groups of exposed (SCT) and non-exposed (TP) patients.   "
148515|NCT01340391|"     An ecologically friendly and biodegradable wood-plastic composite-cast is studied. Patients,     who has sustained a distal radius fracture in need of splinting are requested to participate     in the study.   "
148516|NCT01340378|"     The primary goal of this investigation is to describe perioperative thrombin generation in     neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the     coagulation changes that precipitate postoperative shunt occlusion.   "
148517|NCT01340365|"     To evaluate the effects of Tai Chi—a mind-body exercise--on age-related loss of physiological     complexity (using fractal and entropy based measures), and to understand the relationship     between complexity, function and adaptability, we will conduct a two-arm prospective     randomized clinical trial. Our overarching goal is to evaluate if six months of Tai Chi     training, compared to a waitlist control receiving standard medical care, can enhance     physiological complexity and adaptability in older Tai Chi-naïve adults. Secondary goals of     the study are to characterize the relationship between complexity biomarkers, measures of     function, and resilience. This pilot study will inform a future more definitive trial by     providing information on recruitment and retention, compliance, dose-dependent effects,     preliminary estimates of effect size, and the optimal biomarkers of complexity, function, and     adaptive capacity.   "
148518|NCT01340352|"     Working hypothesis and aims:      To investigate the association between cervical length in non-pregnant women, and the risk of     premature birth.      The participants will be recruited from the HaEmek Medical Center delivery room registration.     Women delivered between 24-37 pregnancy weeks will be allocated to the study group. The     investigators will invite them 3 month or more after delivery to ultrasound examination of     the cervical length. The participants in the control group will be the women whom term     delivery follows by chronological manner to those in study group. Data of the cervucal length     will be collected at the time of the examination.   "
148519|NCT01340339|"     The aim of this study is to compare the efficacy of super-LED reverse phototherapy with the     fluorescent reverse phototherapy in term and late preterm newborns.   "
148530|NCT01340196|"     The objective of this study is to evaluate the drug-drug interaction potential between BI     201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV     infection and/or Hepatitis B infection. Results of this study will serve as a basis for     guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are     coadministered.   "
148520|NCT01340326|"     Angiotensin-converting enzyme inhibitors and angiotensin-receptor blocker valsartan     ameliorate ventricular remodeling after myocardial infarction (MI). Although the amount of     those drugs used in previous clinical trials, therefore recommended in practical guidelines     is maximum clinical dose, it has not been clearly demonstrated whether the recommended dose     is more efficacious compared to lower dose commonly used in clinical practice. In addition,     the impact of genetic polymorphism in neurohormonal system on the pharmacological effect has     not been explored in the setting of post-MI remodeling.      Therefore, the investigators evaluate whether submaximal dose, which are lower than those in     major pivotal trials but typically used in clinical practice, can offer similar benefit in     post-MI ventricular remodeling.   "
148521|NCT01340313|"     Caudal block is the world-widely used technique for an effective postoperative analgesia in     children undergoing OPD-based infra-umbilical surgery. Because the caudal block is usually     performed with a single-shot, proper dosage is required to achieve sufficient analgesic     levels. Several clinical researches have been performed to assess the drug spread levels     using mathematical equation, X-ray evaluation, and ultrasonography during caudal block in     children. In our previous study using fluoroscopy, we obtained the results that the     established weight-based doses provided adequate block levels for each type of surgery.      Ultrasonography is precise tool to evaluate the spinal structures and can provide estimated     information in real time during caudal or epidural block in children.      The aim of this study is to evaluate the drug spread level with a weight-based doses using     ultrasonography during caudal block in children and assess the reliability of the real time     ultrasonography to determine the drug spread levels. After general anesthesia, the patient     will be placed in lateral decubitus position for caudal block. Total 1.5 ml/kg of 0.15%     ropivacaine will be injected into the caudal space. The spread level will be step-wise     evaluated using ultrasonography at the injected drug dose of 0.5 ml/kg, 1.0 ml/kg, 1.25     ml/kg, and 1.5 ml/kg.   "
148735|NCT01337310|"     Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of     tesetaxel in Japanese patients has been limited. This study is being conducted to determine     the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to     Japanese patients.   "
148524|NCT01340274|"     Nova Scotia is experiencing a proliferation of gambling opportunities and their related     gambling problems. The 2003 Nova Scotia Prevalence Study (2004) found that approximately     50,000 adult Nova Scotians are at some risk for problem gambling and that approximately     93,000 adult Nova Scotians are intimately connected to at least one person who has a gambling     problem. The serious consequences of problem gambling are being felt by the Individuals     engaging in Problem Gambling (IPGs), their Concerned Significant Others (CSOs) and their     Communities.      Very few IPGs access support services for their gambling problems. Some reports (National     Gambling Impact Study Commission 1999) have found that only 3% of IPGs seek treatment. The     Nova Scotia Gambling Prevalence Study (2004) states: Overall, 3.5% (26,000 adults) have been     motivated to help someone else with a current gambling problem versus 0.5% (3,700 adults)     seeking assistance or information for a personal problem. While the CSOs of IPGs are seven     times more likely to access professional addiction treatment the options for these     individuals are limited and treatment programs often lack evidence in support of their     effectiveness.      The Community Reinforcement and Family Training (CRAFT) (Meyers & Wolfe 2004) approach     provides significant benefits to the CSOs of persons abusing alcohol and other drugs. They     benefits include: improvement in the quality of life of the CSOs; increasing the rate of     substance abusers entering treatment; and decreased substance use. CRAFT empowers CSOs by     providing tools to positively influence theirs and their significant other's behavior.      The current study investigates the applicability and effectiveness of the CRAFT approach to     the CSOs of IPGS.      It is predicted that benefits to the CSOs receiving CRAFT will significantly surpass those     receiving treatment as usual. The predicted benefits are: improvement in quality of life for     the CSO; engagement of IPGs in treatment; and decreased gambling by the IPGs. With these     achieved outcomes, this research will provide opportunity for earlier intervention, improved     individual and family functioning and a reduction of the negative impact of problem gambling     on the community.   "
148525|NCT01340261|"     The purpose of this study is to describe the demographic, medical, and     psychological/behavioral characteristics of children and adolescent patients admitted to the     Cleveland Clinic Children's Hospital's Pain Rehabilitation Program. The data will also be     used to evaluate the clinical outcomes of patients admitted to the program as well as to     examine the impact of various background factors on clinical outcomes.   "
148526|NCT01340248|"     A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect     on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy     male volunteers.   "
148527|NCT01340235|"     Dowling Meara type of epidermolysis bullosa simplex (EBS-DM) is a rare genodermatosis due to     keratin 5 and 14 mutation, characterized by skin fragility and spontaneous or post traumatic     blisters. Neonatal period and infancy are critical since this autonomic dominant affection     usually improves with age. Cyclins seem to be efficient in some cases of EBS but are     prohibited in children younger than 8 years old. Erythromycin can be a good alternative in     this population due to its antibacterial and anti-inflammatory potential.      The aim of this study is the evaluation of the efficiency of oral erythromycin to decrease     the number of cutaneous blisters in severe EBS-DM patients from 6 months to 8 years old after     3 months of treatment.      Primary end point is the number of patients with decrease of blisters' number of at least 20%     after 3 months of treatment by oral erythromycin.      It is a preliminary study on 8 patients. Treatment is oral erythromycin twice a day during 3     months. Follow up for each patient is 5 months. The duration of the study is 1 year.   "
148528|NCT01340222|"     The threat of preterm labour (PTL) is the first cause of hospitalization in the course of     pregnancy. Its diagnostic is based on clinical examination with a positive predictive value     of about 40 %. The role of the Monocyte chemotactic protein-1 (MCP-1) in delivery has been     suggested by its secretion in the amniotic fluid during labour and by the increase in the     expression of its RNA messengers in the peripheral maternal blood. We have also shown that     the proportion of MCP-1-expressing monocytes is higher in women with vaginal delivery     compared with those with caesarean delivery prior the onset of labour.      OBJECTIVES : Primary To seek link between the respective proportions of circulating maternal     monocyte and lymphocyte subpopulations and the true onset of PTL characterised by delivery     occurring within 7 days post admission. Secondary: to (1) compare the predictive values of     these new markers with those currently used, e.g. quantification of fœtal fibronectin and     assessment of cervical length and effacement, (2) Compare the respective proportions of     monocytes and lymphocyte subpopulations in maternal blood and fœtal membranes, (3) determine     if a correlation exists between the activation markers expressed by maternal monocyte and     lymphocyte subpopulations and the neonatal outcomes of preterm infants.      MATERIAL AND METHODS: 200 patients with a singleton pregnancy between 24 and 34 weeks of     amenorrhea and complicated PTL, will be prospectively included in the maternity wards of     Galway (Ireland) and of Dijon with the support of the perinatal network of Burgundy. A 2X5ml     blood sample will be collected upon admission, at D1, D2, D4 and D6 for women who did not     deliver within the first 7 days; finally, another blood sample will be drawn upon discharge.     After delivery, foetal membranes will be collected to characterize and compare the various     monocyte and lymphocyte subpopulations in the maternal blood. The characterization and the     study of the level of activation of blood and foetal membrane cells will be performed using     flow cytometry technique with suitable markers. The main judgment criteria will be the     percentage of monocytes positively expressing MCP-1 for all three monocyte subpopulations     (inflammatory, residents or patrollers and intermediates, according to CD14, CD16, CCR2     and MCP-1 markers. Lymphocyte subpopulations will be assessed using the following markers:     CD45, CD3, CD4, CD8 (T lymphocytes), HLA-DR (activated T lymphocytes), CD19 (B lymphocytes),     CD16/CD56 (NK Cells), intracellular IFN-gamma (Th1 lymphocytes), intracellular IL-4 (Th-2     lymphocytes), intracellular IL-17 and CCR6 (Th17 lymphocytes), CD4, CD25, Foxp3 and CD127     (Tregs). Univariate statistical analysis of quantitative data will be performed using the     Mann and Witney test or ANOVA, after verification of the conditions of application. The     comparisons of percentages will be done using Chi-square Pearson tests and the Fisher's exact     test, as appropriate. The multivariate analysis will be performed using a stepwise descending     analysis.      TRANSLATIONAL DIMENSION: The characterization of the various monocyte and lymphocyte     subpopulations in the maternal blood and in the foetal membranes might constitute an      immunological signature  of the labour and therefore validate the relevance of a predictive     marker for clinicians.      EXPECTED RESULTS AND PERSPECTIVES: The study of the various monocyte and lymphocyte     subpopulations in the maternal blood will allow to better characterise the immunological     mechanisms occurring at the start of premature labour and to identity predictive markers of     the preterm delivery, to validate prospectively in order to optimize the management of PTL   "
148529|NCT01340209|"     The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over     a 52-week treatment period as compared to placebo. Tiotropium inhalation solution delivered     by the Respimat inhaler will be examined on top of maintenance treatment with inhaled     corticosteroid controller medication in patients with moderate to severe persistent asthma.     Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma     exacerbations, effects on asthma control, and number of adverse events.   "
152341|NCT01289756|"     Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of     Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.   "
148531|NCT01340183|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of the     drug AZD5099 after intravenous administration of single doses in healthy volunteers. The     results from this study will form the basis for decisions regarding the future development of     AZD5099 as a novel antibiotic for the treatment of serious infections in humans.   "
148532|NCT01340170|"     The study objective is to establish that there is no statistical difference in marginal bone     level change comparing a Standard drilling protocol with a Soft bone drilling protocol when     using OsseoSpeed TX and immediate loading.   "
148533|NCT01340079|"     Comparison of 2 methods of delivery health education for African-American women with Type 2     Diabetes. The two methods are: face to face education in small groups, as compared to     delivering the same curriculum in the virtual world, Second Life.   "
148534|NCT01340066|"     The purpose of this study is to determine if a new drug treatment is effective for the     treatment of symptoms of urinary incontinence.   "
148535|NCT01340053|"     This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of     RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition     of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery     of screening procedures to determine eligibility for the trial.      The study will consist of a 2-week treatment-free screening period, a 4-week blinded     treatment period, and a 2-week treatment-free follow-up period.   "
148536|NCT01340040|"     The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in     Japanese subjects with advanced solid tumours refractory to standard therapy or for which no     standard therapy exists.   "
148537|NCT01340027|"     The purpose of this study is to examine how well two medicines in combination (solifenacin     succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.   "
148538|NCT01340014|"     The purpose of this study was to assess patient preference regarding ocular comfort of     AZARGA® compared to COSOPT® after one week instillation of each study medication.   "
148539|NCT01340001|"     Deep brain stimulation has been developed as a substitute for the classical lesioning methods     previously used in stereotactic and functional neurosurgery. Recent, anecdotal cases reports     suggested that electrical stimulation of the cholinergic output of the Nucleus Basalis of     Meynert (NBM) may improve cognitive performances, especially the memory tasks.      The present study aims to assess the effect of bilateral electrical stimulation of the NBM on     the mnesic performance [assessed by the sum of the three free recalls of the Free and Cued     Selective Recall Reminding Test (FCSRT)] in patients diagnosed with probable, moderate,     Dementia with Lewy Bodies.   "
148737|NCT01337271|"     The purpose of this study is to compare a new mode of mechanical ventilation (NAVA, or     Neurally adjusted Ventilatory assist) with a traditional mode (Pressure Support ventilation)     on its the ability to detect patients ready for extubation (liberation from mechanical     ventilation).   "
148540|NCT01339988|"     Long-term follow-up studies have demonstrated significant late toxicities of total body     irradiation (TBI), which are most marked in children radiated at a young age. Growth failure,     decline in cognitive function, and endocrine abnormalities have all been described. Good     outcomes can be achieved with alkylating agents only as a preparative regimen. This plan will     use a combination of busulfan and cyclophosphamide (Bu/Cy) with or without antithymocyte     globulin (ATG) to reduce the late toxicities of therapy that includes TBI.   "
148541|NCT01339975|"     Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a     constant increase in its mortality and consequently requires an important involvement in     translational research.      The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers     in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown     anti-angiogenic and anti-tumor properties in experimental models and may be particularly     interesting for prognostic and predictive purposes.   "
148542|NCT01339962|"     Non-interventional study. Data obtained by patient chart reviews.      Retrospective analysis of progression free survival, time to treatment failure and overall     survival in a national cohort of patients with metastatic renal cell carcinoma treated in     Denmark from 2006-2010 Safety, prognostic factors, predictive factors and co-morbidity     assessed by Charlson Comorbidity Index.      The following drugs will be evaluated: Sunitinib, Sorafenib, Temsirolimus, Everolimus,     Aldesleukin, Interferon-alfa-2b.   "
148543|NCT01339949|"     The objective of this study is to confirm the safety and to establish the effectiveness of     low voltage external beam radiosurgery using the IRay System for the treatment of subjects     with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as     determined by decreasing the number of Lucentis injections required during the first 12     months of the study.   "
148544|NCT01339936|"     The main objectives of the investigation will be to assess the effect of the repeated usage     of an investigational eye drop on the tear film characteristics of dry eye sufferers and     demonstrate the benefit of this eye drops for dry eye sufferers.   "
148545|NCT01339923|"     The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when     administered alone without routine infant vaccines to healthy infants in their first year of     life according to different two and three dose immunization schedules, which are suitable to     be adopted by various national programs. This study will also investigate antibody     persistence post primary series and administration of a subsequent booster dose of rMenB+OMV     NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of     two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of     age.      This study will also evaluate the safety and immunogenicity of the concomitant administration     of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and     12-month schedule.   "
148546|NCT01339910|"     The study is designed as a Phase III, multicenter trial comparing outcomes after allogeneic     hematopoietic stem cell transplantation (HCT) for acute myeloid leukemia (AML) or     myelodysplastic syndrome (MDS) between patients receiving myeloablative conditioning (MAC)     versus reduced intensity conditioning (RIC) regimens.   "
148547|NCT01339897|"     This Phase 1 study will evaluate multiple doses across a range that has been found to be     effective in mouse models of asthma and safe in one Phase 1 clinical trial. It is intended to     provide evidence of the tolerability of multiple doses as well as provide information on the     Pharmacokinetic (PK) and metabolism of N6022 in humans.   "
148548|NCT01339884|"     The purpose of this study is to determine the effect of two doses of resveratrol taken for a     12 week period, on frataxin levels in individuals with Friedreich ataxia. This study will     also measure the effect of resveratrol on markers of oxidative stress, clinical measures of     ataxia, and cardiac parameters.   "
148549|NCT01339871|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of pazopanib and vorinostat that can be given to patients with advanced cancer.     The safety of the drug combination will also be studied.   "
148550|NCT01339858|"     The primary objective of this study is to determine if NAC, added to existing antipsychotic     treatment, is superior to placebo for cortical erosion in patients with early stage     psychosis. The primary hypothesis is that there will be significantly less cortical erosion     as measured by cortical thickness, cortical volume and cortical white matter density     (assessed by DTI) in patients treated for 12 months with NAC as compared to those treated     with placebo. The secondary objectives of this study are to determine if 12 months of NAC     add-on treatment is superior to placebo for fMRI determined working memory and semantic     memory tasks, cortical MR spectroscopy measures (glutathione, N-acetylaspartate, and     glutamine/glutamate levels), electrophysiologically determined attention measures (e.g.,     mismatch negativity, P300), symptoms, functional measures and cognitive functioning.   "
148551|NCT01339845|"     The purpose of this study is to conduct and evaluate the feasibility and effectiveness of a     mass cholera vaccination program to reduce diarrhea due to Vibrio cholerae in a high     incidence urban area. This study will also evaluate the feasibility of adding a household     hand washing and safe drinking water promotion intervention to a cholera vaccine program and     the overall impact of this combination on decreasing the incidence of diarrhea due to Vibrio     cholerae.   "
148552|NCT01339832|"     This observational study is a follow-up study of protocol ML18280. Survival data of patients     who took part in and concluded study ML18280 will be collected for up to 5 years after LPLV     of ML18270.   "
148553|NCT01339819|"     The aim of this study is to evaluate whether Dabigatran itself reduces ADP induced platelet     aggregation measured by MEA as compared to Phenprocoumon after a two-week treatment with     either agent.   "
148582|NCT01339442|"     This phase I trial will determine the Maximum Tolerated Dose (MTD) of BKM120 when given     together with fulvestrant in treating postmenopausal patients with estrogen receptor-positive     (ER+) stage IV breast cancer. The toxicity profile of this combination therapy will also be     described. Inhibition of PI3K by BKM120 may enhance programmed cell death (apoptosis) in     estrogen receptor positive (ER+) breast cancer cells. Giving fulvestrant together with BKM     120 may enhance this apoptotic effect, providing a novel therapeutic strategy for patients     with metastatic ER+ breast cancer.   "
148554|NCT01339806|"     The objective of this trial is to evaluate the effectiveness of cognitive rehabilitation in     OIF/OEF service members with a history of mild traumatic brain injury and persistent (3-24     months post injury) cognitive complaints. This is a prospective, randomized, control     treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of     mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive     complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service     at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the     treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study.     Subjects will be evaluated prior to the start of treatment and 3, 6, 12, and 18 weeks     following the initiation of the study. The total number of patients to be studied is 160     (maximum), which is approximately 20 patients per month.   "
148555|NCT01339793|"     In recent years, many hospitals have progressively perceived the importance of corporate     social responsibility (CSR). More and more hospital superintendents thus have realized that     they should have a CSR strategy to deal with various stakeholders. Hospital, as a health care     sector, is a labor-intensive industry. The management of hospitals should view its employees     as salient stakeholders as well as a sort of precious asset by which hospital can possess a     unique competition advantage in the operation. It is therefore important for superintendent     to understand an employee's perspective on CSR and its impact on employees' work attitudes     and organizational performance.   "
148556|NCT01339780|"     Prostate and breast cancer continues to be the most common cancer among men and women,     respectively. The exact assessment of the cancer spread with detection of possible bone     metastasis is crucial for treatment decision. In the current study 50 patients with prostate     cancer and 50 patients with breast cancer at high risk for bone metastases or with know     metastatic disease will be studied with multiple imaging modalities. Patients will be     recruited from the Department of Oncology, Turku University Hospital. Planar bone     scintigraphy (BS), single photon emission computed tomography combined with low-dose computed     tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT)     and magnetic resonance imaging (MRI) will be performed to all patients. The primary objective     is to determine the diagnostic accuracy of the four imaging modalities. The secondary goal is     to calculate the sensitivities and specificities of the four imaging modalities on a     patient-to-patient and lesion-to-lesion basis. Based on the results of this study an optimal     imaging protocol for detection of prostate and breast cancer bone metastasis will be     developed and validated.   "
148557|NCT01339767|"     The purpose of this study is to learn more about risk factors for autism by studying the     behavior and brain functioning of toddlers with early communication delays and typically     developing toddlers. Children 12 or 18 months of age with language delays (i.e., no words at     18 months, limited vocalizations at 12 months) and typically developing toddlers may be     eligible to participate. This study will be conducted at the NIH Clinical Center in Bethesda,     Maryland. There will be an initial screening evaluation that will include behavioral     assessment. Eligible participants will then complete a baseline visit that includes an     overnight sleep study that includes Electroencephalogram (EEG) test to measure brain     electrical activity, and an MRI scan. Follow-up visits that include behavioral assessment     will occur every 6-12 months, depending on age at study entry. The final study visit will     occur at 36 months of age and will include behavioral assessment, sleep/EEG study, and MRI.     There is no cost for participation. Compensation will be provided. To find out if your child     qualifies or for more information, please call 301-451-7822 (TTY: 1-866-411-1010) or e-mail     NIMH-ASD@mail.nih.gov. National Institute of Mental Health, National Institutes of Health,     Department of Health & Human Services....   "
148558|NCT01339754|"     RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with     metastatic pancreatic cancer after first-line chemotherapy.   "
148559|NCT01339741|"     The purpose of this research is to study whether vitamin D supplement can improve clinical     outcome (PASI score) in psoriasis vulgaris with vitamin D insufficiency and deficiency.   "
148560|NCT01339728|"     The purpose of the present study was to investigate the effect of far-infrared ray at CV12     acupoints area on the skin temperature and skin blood flow of palm central area of right     hand, and the correlation between them.   "
182742|NCT00234689|"     Assessing the efficacy of Naltrexone as augmentation to SSRI in patients with OCD   "
148561|NCT01339715|"     The purpose of the study was to investigate the changes of Ryodoraku value at 12 source     acupoints, and heart rate viability (HRV) when acupuncture or far-infrared ray illumination     applied to CV12 acupoint.   "
148562|NCT01339702|"     Evaluation of the impact (on survival and other outcomes) of implementing the Brain Trauma     Foundation/National Association of EMS Physicians Traumatic Brain Injury (TBI) guidelines in     the prehospital EMS systems throughout the state of Arizona.   "
148563|NCT01339689|"     This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled,     15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress     Disorder (PTSD). Up to 120 subjects will be enrolled and randomized to receive either     ganaxolone or placebo for 6 weeks. After 6 wks of randomized treatment all subjects will     continue for 6 wks on ganaxolone. The aim of the study is to assess the efficacy of     ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment     using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to     evaluate the safety and tolerability of ganaxolone in the PTSD population.   "
148564|NCT01339676|"     This is a multi-centre, double blind, randomised, placebo controlled, parallel group, phase 4     pilot study investigating colecalciferol (vitamin D3) as an add-on treatment to     subcutaneously administered interferon-beta-1b in relapsing-remitting multiple sclerosis     patients.   "
148583|NCT01339429|"     The objective of this study is to implement a simplified Negative Pressure Wound Therapy     (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device     is at least equivalent to commercially available NPWT devices. Therefore, the specific aims     of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the     adverse events associated with the sNPWT device.   "
148565|NCT01339663|"     This phase I trial studies the side effects and best dose of autologous T-antigen-presenting     cells (T-APC) vaccine following therapeutic autologous lymphocytes (CTL) and cyclophosphamide     in treating patients with metastatic melanoma. Aldesleukin may stimulate lymphocytes, such as     CTL, to kill melanoma cells. Treating lymphocytes with aldesleukin in the laboratory may help     the lymphocytes kill more tumor cells when they are put back in the body. Vaccines made from     melanoma antigen may help the body build an effective immune response to kill tumor cells and     may boost the effect of the CTL. Drugs used in chemotherapy, such as cyclophosphamide, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving T-APC vaccine after CTL and cyclophosphamide may be an     effective treatment for melanoma   "
148566|NCT01339650|"     This is a Phase 1, dose escalation trial evaluating the tolerability, pharmacokinetics, and     pharmacodynamics of ABT-767 in subjects with advanced Breast Cancer 1 or 2 gene (BRCA1 or     BRCA2)-mutated solid tumors and high grade serous ovarian, fallopian tube, or primary     peritoneal cancer.   "
148567|NCT01339637|"     The overall objective of this study is to increase the number of dark skin tone individuals     in the data set and evaluate if this increase in dark skin tone data has an impact on the     accuracy of the SCOUT DS Diabetes Risk Score (DRS).   "
148568|NCT01339624|"     The purpose of this study is to determine whether nasal fentanyl is effective in the     treatment of renal colic in adults in emergency department.   "
148569|NCT01339611|"     The aim of the study is to test if patients under oral anticoagulation therapy who are going     to participate in the education program will have better Health-related quality of life,     higher rate in pharmacological treatment adherence and better self efficacy to manage the     treatment.   "
148570|NCT01339598|"     This study aims to investigate the potential for Transcranial Direct Current Stimulation     (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the     effect of active or sham tDCS (placebo control) during the performance of two cognitive     tasks. The investigators hypothesize that task performance will be improved with active     relative to sham tDCS.   "
148571|NCT01339585|"     This project will investigate a novel strategy for enhancing cognitive training (CT).     Specifically, the investigators aim to combine a non-invasive form of brain stimulation     (tDCS) with CT. This study will examine the optimal time interval - whether tDCS should be     administered either before or during CT.   "
148572|NCT01339572|"     This protocol will investigate the effectiveness of plerixafor in the up-front setting in     avoiding a second round of mobilization and whether this translates into a clinical and     economic benefit.   "
148573|NCT01339559|"     This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and     single arm study of brivaracetam (BRV).   "
148574|NCT01339546|"     The rationale for this study is to assess the change in ambulatory care visit rates for acute     otitis media between the period before (2001-2009) and after the introduction of the     13-valent pneumococcal conjugate vaccine (13vPnC) (2011-2013) among children less than 5     years old in the United States.   "
148575|NCT01339533|"     APRV mode of ventilation will result in an improved partial pressure of arterial oxygenation/     fraction of inspired oxygen (P/F ratio) on day 3 of mechanical ventilation. Sub hypotheses:     APRV will be associated with a reduced amount of sedation used during the ICU stay in     patients with respiratory failure. APRV will be associated with a reduction in the amount of     vasoactive medication used for blood pressure support in patients with respiratory failure.   "
148576|NCT01339520|"     The purpose of this study is to see if the use of a diabetic scorecard during clinic visits     can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and     amount of exercise in adults over age 40 with uncontrolled Type II diabetes.   "
148577|NCT01339507|"     The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after     instillation.   "
148578|NCT01339494|"     Introduction      Baylor College of Medicine and Texas Children's Hospital are recruiting individuals with     MELAS syndrome for a clinical study. MELAS syndrome is a mitochondrial disease; patients with     this disease have muscle weakness and often develop brain strokes, where blood does not flow     normally to different parts of the brain. It is believed that these strokes could be due to     decreased production of nitric oxide, a naturally occurring compound important for normal     blood vessel function. Nitric oxide is made from arginine and citrulline that are normally     found in our bodies.      What is the purpose of this study? The purpose of this study is to measure nitric oxide in     individuals with MELAS and see if giving arginine or citrulline will increase the formation     of nitric oxide. Nitric oxide is thought to be helpful in preventing strokes. Therefore, if     arginine and/or citrulline are shown to increase the formation of nitric oxide, they could be     used to prevent or treat the strokes in patients with MELAS syndrome.   "
148579|NCT01339481|"     The purpose of this study is to characterize CD86 receptor occupancy in subjects with     rheumatoid arthritis (RA) receiving abatacept.   "
148581|NCT01339455|"     Neuromyelitis Optica (NMO) is a demyelinating and degenerative disorder of the CNS affecting     vision and spinal cord function. This disease is rare compared to Multiple Sclerosis (MS),     but it is devastating and often leads to accumulating disability with a 5 year-mortality of     approximately 30%. Survivors are typically left with severe morbidity secondary to blindness,     quadriparesis and respiratory failure. No agent has been found to be highly effective in     halting disease activity. Based on recent outcomes of stem cell transplant trials and reports     in autoimmune diseases including MS, and based on the mechanisms of NMO, we anticipate that     stem cell transplantation may provide lasting disease stability for NMO patients. The     hypothesis of the present trial is that autologous hematopoetic stem cell transplantation in     patients with NMO will provide lasting benefit in relapse prevention. Specifically, we     anticipate a 50% reduction in the proportion of patients experiencing relapse over a three     year period. We will be following patients for a total of five years after transplantation.   "
148584|NCT01339416|"     Human Immunodeficiency Virus (HIV) infected patients in the HIV registries of Johns Hopkins     University, University of North Carolina and Vanderbilt University will be followed in the     routine clinical care to estimate the rates of prespecified clinical events in this     population.   "
148585|NCT01339403|"     Human Immunodeficiency Virus (HIV) infected patients in the Kaiser Permanente HIV registry     wil be followed in the usual clinical care to estimate the rates of specified clinical     events. The rates will be stratified by relevant characteristics like age, CD4 counts, HIV     Viral Load (VL), HIV medication history. The rates in the HIV infected cohort wil be compared     with the rates of these events in patients in the Kaiser Permanente database who are not     infected with HIV.   "
148586|NCT01339390|"     Obesity has been linked to several serious medical conditions, including high blood pressure,     diabetes, and poor cholesterol levels. For this reason, obesity is likely the most important     single contributor to cardiovascular mortality in the United States. Fortunately, intensive     weight management programs are an effective treatment for obesity. Such programs help people     lose weight and improve their measures of cardiac risk. In response to the growing numbers of     obese Veterans being treated at Veterans Health Administration (VHA) facilities, the VHA     developed the MOVE! Program. Veterans who commit to MOVE! and participate actively do lose     weight. Unfortunately, MOVE!, like other weight management programs, requires its     participants to attend classes and to exercise, often at locations and times that are     inconvenient. The investigators propose to make it easier for eligible patients at the     Zablocki Veterans Affairs Medical Center (ZVAMC) to participate by offering MOVE-style     classes and exercise groups at a variety of locations, days, and times. The investigators'     program-MOVE OUT-may provide a model for VHA to use nationwide.   "
148587|NCT01339377|"     To evaluate the safety and effectiveness of the AO-1000 device to treat and relieve the pain     of symptomatic subjects with contained herniated discs. This single-arm pilot study will be     used as a go vs. no-go decision on performing a randomized-controlled trial.      The study's primary effectiveness objective is to demonstrate that the patient's     functionality (based on Oswestry Disability Index scores) has improved from baseline at one     month. The study's primary safety objective is to demonstrate that serious device/procedure     related adverse events and subsequent surgical interventions are no greater than those in a     literature control of other percutaneous disc decompression procedures at discharge, 1 month,     6 months, and 12 months post-treatment.      Secondary objectives are to demonstrate procedural success and improvement in the pain and     function of the subjects at 1, 6, and 12 months using the VAS and ODI scales as well as     tracking analgesic medication use. Pain and function scores for each follow-up time will be     compared to the baseline scores.   "
148588|NCT01339364|"     This study is a three-arm randomized controlled trial to evaluate the effects of 1-day     continuing educational meetings for community pharmacists with three distinct educational     methods: 1) Didactic lecture 2) Didactic lecture plus case discussion in a large group 3)     Didactic lecture plus small group education with simulated patient      Knowledge and attitude of the participants would be measured as the study outcome in three     periods: pre-education, post-education and 1 month after the meetings.   "
148598|NCT01339234|"     This study is a pilot trial to evaluate the effects of supported treadmill walking in     patients with primary progressive multiple sclerosis (MS) on functional and psychosocial     outcomes. Patients will exercise three times per week over the course of 6 months and will be     evaluated at baseline, 12 weeks and 24 weeks into the program. Follow-up testing will also be     conducted 12 weeks after participants have stopped exercising to determined the lasting     effects of the intervention.      The investigators hypothesize that supported treadmill walking will be effective at improving     physical physical function and psychosocial outcomes in patients with primary progressive MS.   "
148599|NCT01339221|"     The main aim of this study is to investigate cases of rotavirus gastroenteritis in Belgian     children with opportunity to receive Rotarix™ to monitor the potential occurrence of genetic     drifts (point mutations) in the vaccine strain and the occurrence of genetic shifts     (re-assortments) between vaccine and naturally circulating wild-type strains in Belgium     population after the introduction of Rotarix™. The study will also detect if there is any     alteration in rotavirus pathogenicity conferred by re-assortment and if the mutated vaccine     strain is still efficacious in preventing rotavirus gastroenteritis.   "
149387|NCT01328704|"     The purpose of this study is to observe changes in iron status and vitamin D status during a     12-24 week supervised training program, specifically males and females between the ages of 30     and 50 years old.   "
148589|NCT01339351|"     African American women with breast cancer have decreased quality of life (and mood when     compared to European American. Research has not examined the effectiveness of therapeutic     group for African American women with breast cancer even though positive effects are well     established for Caucasians. The aims of the randomized clinical trial are to determine the     effectiveness of TG by teleconference for African American women with breast cancer and what     factors may impact on the intervention. The primary hypothesis is that participants in the     intervention group will have significantly greater cancer knowledge, less fear, less     isolation, better social connection, better mood, and better QOL when compared to a control     group receiving usual psychosocial care. Two hundred forty African American women with breast     cancer will be recruited. Intervention participants attend eight weekly 90 minute sessions by     teleconference and two follow-up boosters. Each culturally appropriate session contains the     story, information and group processes of connection, commonality and catharsis. Information     focuses on increasing self care and stress management knowledge while countering myths and     taboos. Story capitalizes on African American oral traditions by discussing coping parables.     Group processes provide an alternative source of social support and opportunities to express     feelings. Control group subjects receive standard psychosocial care (the use of any support     programs or services locally or nationally. Testing will occur at baseline, after 10 group     sessions and 16 weeks post baseline. The study findings are expected to inform about the     effectiveness of therapeutic groups in African American women with breast cancer and lay the     groundwork for exploring if reducing disparities in psychosocial care have a health benefit.   "
148590|NCT01339338|"     The purpose of this study is to compare the use of warm-media with cold-media in performing     hysterosalpingography (HSG).   "
148591|NCT01339325|"     The aim of this study is to assess possible differences between the LESS approach and the     standard laparoscopic approach to cholecystectomy. In particular, the Postoperative Quality     of Life (QoL) will be investigated by analyzing the followings: length of hospital stay     (LoS), postoperative pain, cosmetics and the results of SF 36 questionnaire. Furthermore,     operative time, conversion to standard LC rate, difficulty of exposure, difficulty of     dissection, and complication rate will be compared.   "
148592|NCT01339312|"     This study is designed to gather safety and immunogenicity data with Purified Vero Rabies     Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule,     using the Essen regimen, across different populations.      Primary Objective:        -  To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab          vaccine, in terms of proportion of participants with a rabies virus neutralizing          antibody titer ≥ 0.5 IU/mL at Day 14, i.e., before the fourth vaccination, in          participants aged 10 to 17 years and in participants aged 18 years and over.      Secondary Objectives:        -  To assess the clinical safety of VRVg after each vaccination when administered in a          post-exposure prophylaxis vaccination schedule in each respective age group and overall        -  To describe the immune response induced by VRVg before the fourth vaccination and 14          days after the last vaccination in each respective age groups and overall.   "
148593|NCT01339299|"     The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study     to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human     chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in     normogonadotrophic women.   "
148594|NCT01339286|"     Attention deficit hyperactivity disorder (ADHD) is the most common behavior disorder, with     the prevalence of 3% to 6% in children and adolescents. The patients' academic achievements,     professions and social livings are impaired. Comorbid antisocial behavior, substance abuse     and delinquency burden family and society. Stimulants used to be the first line drug. But the     medication compliance is poor because of strict drug administration. Atomoxetine is a new     non-stimulant drug, which can effectively improve ADHD symptoms. But it achieves effect     slowly, the drug responses differ significantly, and side effects interfere compliance. Since     genetic factors is the most important cause for different drug responses, this project     studies candidate genes potentially associated with atomoxetine medication, with the aim to     find 2 to 3 gene polymorphisms influencing the drug response of ADHD. The study adopts cohort     design. A sample of more than 100 ADHD cases with atomoxetine medication is to be collected.     The rapid genotyping of large sample depends on high-through laboratory. New statistic method     is to be used to improve the sensitivity of the target gene detection. There has been no such     report in country and overseas. This project will provide basic information for forecasting     drug response, improving clinical effects, tolerance and long-term compliance.   "
148595|NCT01339273|"     Laparoscopic (key-hole) large bowel resection is a minimally invasive procedure when compared     to open large bowel resection, but is still associated with a significant amount of pain and     discomfort. Analgesia is commonly provided by a multi-modal technique involving varying     combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional     analgesia and oral or parenteral opioids. While epidural analgesia is considered the gold     standard for open colo-rectal procedures it can be associated with significant complications     and may delay hospital discharge in laparoscopic procedures. Opioids are associated with an     increased incidence of nausea, vomiting and sedation and reduced bowel motility which can     also prolong recovery.      Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain     sensation from the abdominal wall and provides effective and safe analgesia with minimal     systemic side effects. Their perceived benefits are thought to relate to reduced opioid     consumption and therefore reduced opioid side effects. The investigators believe ultrasound     guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient     satisfaction, earlier return of bowel function and earlier hospital discharge.      The key research question the investigators are trying to answer is whether TAP block provide     better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both     techniques are currently being used in our hospital and a retrospective audit demonstrated     better analgesia and lower consumption of morphine in the TAP block group.The differences     were not statistically significant as the number patients in the audit were not large     enough.The investigators are hoping that this study will demonstrate that the difference is     real by recruiting the necessary number of patients into each group (36 per group)   "
148596|NCT01339260|"     NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of     netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with     oral dexamethasone. The objective of the study is to demonstrate that netupitant and     palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting     induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles     of chemotherapy.   "
148597|NCT01339247|"     The study is prospective, open, randomized, crossover in steady state and the volunteers     received multiple doses of the test drug and the reference drug (two periods of drug     administration after standardized meals).   "
148600|NCT01339208|"     The purpose of this study is to evaluate the feasibility and clinical efficacy of an     innovative care model that combines Telemedicine consultations, educator therapeutic     management and diabetes education to empower patients to be in greater control of their own     diabetes care for improvements in diabetes outcomes.   "
148601|NCT01339195|"     Projections from epidemiological studies suggest that, among the Western adult population,     one in three will present a cerebrovascular accident (stroke), severe cognitive disorders, or     both. To better diagnose the Vascular Cognitive Impairment, new standards were developed by a     North America working group which are under validation. It is essential to adapt these     standard for French-speaking population, and especially to define cutoff scores of the     cognitive battery to determine cognitive deficit.      The investigators propose a study coordinated by the University-Hospital of Amiens for french     speaking centers. This study will investigate this battery with 906 controls to define the     standards and 302 stroke affected patients to define the frequency and cognitive mechanisms.     This step is essential for people to benefit from these new standards.   "
148602|NCT01339182|"     This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of     a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data     for the design and conduct of subsequent studies.   "
148619|NCT01338961|"     Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a     century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To date,     most studies have been conducted in coronary artery bypass graft (CABG) patients with     conflicting results. Current evidence does not support one temperature management strategy     for all patients. The purpose of this study is to compare the efficiency and safety of     normothermic versus hypothermic CPB in valvular surgery patients.   "
148620|NCT01338948|"     The purpose of this study is to assess the feasibility of image-guided surgery in patients     with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the     assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance     of will indicate the failure.   "
148603|NCT01339169|"     The aim of the study is to find out if the experimental medicine, YF476, can make gastric     carcinoids, a rare type of stomach tumour, shrink and disappear. Gastric carcinoids occur     mainly in patients with chronic atrophic gastritis (CAG), a condition in which the     acid-producing cells in the lining of the stomach can't make acid. Acid production is     controlled by gastrin, a hormone (chemical messenger) that's released into the bloodstream.     If the stomach can't make acid, blood levels of gastrin rise. High blood levels of gastrin in     patients with CAG can cause other cells (ECL cells) in the lining of the stomach to grow and,     over the years, to give rise to gastric carcinoids. Gastric carcinoids are usually benign,     but they can become malignant. Therefore, patients with CAG and gastric carcinoids have the     inside of their stomach checked regularly, by gastroscopy, to see if the gastric carcinoids     need removing surgically. A gastroscope is a thin (1 cm), flexible tube at end of which is a     mini video camera, which enables the user to inspect the lining of the stomach and a 'snare'     to take samples of tissue (biopsies). YF476 (netazepide) is a gastrin receptor antagonist     (blocks the effects of gastrin), so it's a potential new medical treatment for gastric     carcinoids in patients with CAG. Up to 10 of these patients will take YF476 daily for up to     12 weeks. If they benefit from that treatment, they may take YF476 daily for up to another 52     weeks. They'll make several outpatient visits for tests, including checks on the safety of     YF476. At some of the visits, they'll have a gastroscopy. At each gastroscopy, the gastric     carcinoids will be measured and biopsies taken for laboratory tests.   "
148604|NCT01339156|"     P3914 a pro-drug of Naproxen, characterized by naproxen (COX inhibiting moiety) linked to a     NO moiety is intended for the treatment of pain and inflammation. The rationale behind     development of P3914 is to maintain the analgesic, antipyretic and anti-inflammatory activity     of naproxen and enhance GI safety by virtue of release of NO besides with no major effect on     blood pressure on long-term administration.   "
148605|NCT01339143|"     The purpose of this study is to compare the effect of vildagliptin vs. pioglitazone to     oxidative stress on daily blood glucose fluctuations, in patients with type 2 diabetes that     was inadequately controlled by metformin.   "
148606|NCT01339130|"     Empathy, defined as the ability to understand others emotions, is a fundamental concept in     social interactions. It is a psychological phenomenon involving various separable components     : (i) the ability to feel and imagine the emotions, (ii) the ability to adopt the perspective     of other people. Several neurological diseases with behavioral disorders may lead to impaired     processing of social and/or emotional informations. These pathologies are likely to induce a     lack of empathy that may result from impairments at different levels.      The objective is simply to study how others' emotions are understood and how this allows for     regulation of personal behavior. This study is being carried out among patients seen for     various health problems and who can make behavior changes. This study could help to     understand some neurological diseases and thereby to identify them earlier and/or to better     differentiate them.   "
148607|NCT01339117|"     The purpose of this study is to determine whether a specific diet may help children with     irritable bowel syndrome.   "
148608|NCT01339104|"     Open label Phase I study of Regorafenib to evaluate cardiovascular safety, tolerability and     anti-tumor activity in patients with advanced solid tumors   "
148609|NCT01339091|"     The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy)     of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral     linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial     skin or skin structure infection.   "
148610|NCT01339078|"     Biliary anastomotic strictures (post liver transplantation) occur in 15-20 % of the cases.     Biliary stenting using plastic prosthesis during a period of 1 year is the treatment of     choice. Problematic in this approach is the regular change, necessary to overcome occlusion     of the stent, resulting in cholestasis and/or infection. This change needs to be performed     every 3 months or more frequently in patients with symptoms of stent occlusion.      The Kaffes stent (RMS) is a metallic removable stent, especially constructed for the     treatment of biliary anastomotic strictures post liver transplantation. The advantage could     be that this stent is less prone to occlusion with a lower change frequency (e.g. every 6     months).      No randomized, controlled trial (RCT) or data exist comparing plastic stenting versus Kaffes     stenting.   "
148611|NCT01339065|"     . Null Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients     undergoing elective surgery, in Mulago hospital, will not have a reduction effect on the     levels of IL-6 & IL-1β pro inflammatory markers by 48 hours.      . Alternate Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult     patients undergoing elective surgery, in Mulago hospital, will have a reduction effect on the     levels of IL-6 & IL-1β pro inflammatory markers by 48 hours.   "
149110|NCT01332370|"     This retrospective database study analyzed resource utilization and costs associated with     sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET) monotherapy     among adults with a diagnosis of diabetes who were continuously enrolled in a large US     healthcare plan.   "
148612|NCT01339052|"     BKM120 is a newly discovered drug that has been used in other research studies. Information     from those other research studies suggests that BKM120 may help to slow or stop the growth of     malignant gliomas. The purpose of this study is to see how well BKM120 works in patients with     malignant gliomas. Patients on this study will be treated in two groups: patients who are     going to receive surgery and those who will not receive surgery. This study is trying to     determine how effective BKM120 is in stopping cancer cells from growing. For patients     receiving surgery the research will also try to determine if an effective level of BKM120 can     penetrate the brain before surgery.   "
148629|NCT01338831|"     The purpose of this first multi-dose study in cancer patients is to determine the maximum     tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety,     tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D     chosen, the study will enroll patients into the expansion portion of the study.   "
148630|NCT01338818|"     This study will evaluate the long-term safety of methylphenidate hydrochloride extended     release in adults with attention deficit/hyperactivity disorder   "
148631|NCT01338805|"     This long-term extension study will assess the safety, tolerability and efficacy of BGG492 as     adjunctive treatment in patients with partial onset seizures.   "
148613|NCT01339039|"     Plerixafor in combination with bevacizumab is a drug combination that may stop cancer cells     from growing abnormally. Bevacizumab, also known as Avastin, is FDA approved for use in     patients with recurrent glioblastoma and has been studied extensively in other types of solid     tumors. Plerixafor, also known as Mozobil, is FDA approved for use in patients with     non-Hodgkin's lymphoma and multiple myeloma and has been used in treatment for other cancers.     Information from experiments in laboratories suggests that the combination of plerixafor and     bevacizumab may help prevent the growth of gliomas.      Part 1: The investigators are looking for the highest dose of plerixafor that can be given     safely with bevacizumab (with a 21 days on/7 days off regimen of plerixafor). The     investigators will also do blood tests to find out how the body uses and breaks down the drug     combination.      Part 2: The investigators are looking to see if plerixafor can get past the blood-brain     barrier and into brain tumors. The investigators will also do blood tests to find out how the     body uses and breaks down the drug combination.      Part 3: The investigators are looking for for more information re: safety and tolerability of     plerixafor in combination with bevacizumab (with a 28 days on/0 days off regimen of     plerixafor). The investigators will also do blood tests to find out how the body uses and     breaks down the drug combination.   "
148614|NCT01339026|"     Patients admitted to hospital with chest pain due to reduced blood flow to heart muscle     (diagnosis Acute Coronary Syndrome) can be treated with medication and an angioplasty ± stent     procedure, which restores blood flow to the heart. Antiplatelet drugs (Aspirin and     Clopidogrel) are blood thinning treatments and research has reported they reduce heart     attacks, death and stroke. The investigators know some patients do not respond fully to     Clopidogrel but currently patients are not tested for this.      The investigators wish to perform a trial to identify those patients who do not respond fully     to Clopidogrel and randomise them to either Prasugrel (newer drug) or a higher dose of     Clopidogrel.      Patients admitted to the hospitals (2 in the UK and 1 in Germany) will be asked for their     consent to participate. A blood sample is tested for platelet activity.        1. Low platelet activity result means patient has responded well to Clopidogrel and will          continue on the routine dose. They will be entered into an observational registry. Data          will be collected of routine blood tests and investigations, medication and procedures.          Their GP will be contacted at about 30 days to see if they are alive.        2. High platelet activity results means patient has not responded fully to Clopidogrel.          These patients will be randomly allocated to a higher dose of Clopidogrel or new drug          Prasugrel. Data will be collected of routine blood tests and investigations, medication          and procedures. A hospital visit at 30±5 days is required to assess how patients are          doing, medications and occurrence of any events.   "
148615|NCT01339013|"     The anesthesia gas reflector (AnaConDa) is built on the adsorptive capacity of active carbon     which also adsorbs carbon dioxide in exhaled air. Rebreathing of carbon dioxide thus occurs     and must be compensated for by increased ventilation. This study aims at determining how much     compensation must be given, based on the hypothesis that rebreathing depends on carbon     dioxide level in blood and exhaled air.   "
148616|NCT01339000|"     Background: Drugs given to treat cancer (chemotherapy) can weaken the human immune system.     But it can also become weaker because of aging. Interleukin (IL)-7, a molecule produced     naturally in the body, can help improve the function of the immune system. Researchers want     to study the effects of IL-7 on immune system function in two different groups of older     people. One group will be people who have received vaccines before IL-7. The other group will     be people who have received Vaccines after IL-7.      Objectives: To evaluate the effect of IL-7 on the immune system responses to vaccines in     older people following chemotherapy.      Eligibility: People at least 60 years of age who have recently finished chemotherapy for     breast, colon, or bladder cancer.      Design:        -  People in the study will be screened with a physical examination, medical history, and          blood tests. Other screening tests, such as tumor imaging, may also need to be          performed.        -  Everyone will receive a series of five different vaccines commonly used to prevent          diseases. We will compare the responses of people in Sequence 1 who will receive          vaccines before IL-7 with the responses of people in Sequence 2 who received the same          vaccines after IL-7.        -  The vaccines will be given randomly in two Arms at different times.             -  Arm 1: diphtheria and tetanus, polio, pneumonia (with two booster shots), hepatitis               B (with two booster shots), and hepatitis A (with one booster shot),             -  Arm 2: hepatitis A (with one booster shot), hepatitis B (with two booster shots),               pneumococcal (with two booster shots), diphtheria and tetanus, polio, pneumonia               (with two booster shots)        -  There are 5 vaccines to be given to each subject, following one of two randomly assigned          sequences of vaccine administration (Sequence 1 or Sequence 2).        -  The first vaccine arm contains the two diphtheria protein containing vaccines tetanus          and diphtheria (Td) and pneumococcal conjugate 13 (PCV13) and polio. The second vaccine          arm contains the Hepatitis A and Hepatitis B vaccines. Subjects will either get tetanus,          diphtheria, polio, and pneumonia vaccines before IL-7 therapy (Sequence 1) or hepatitis          A and hepatitis B vaccines before IL-7 therapy (Sequence 2). The response to vaccines          will be evaluated 4 weeks after vaccination. This will be followed by IL-7 therapy, then          administration of the other group of vaccines. Therefore, subjects on both arms will          receive the same set of vaccines, just at different times with respect to IL-7 therapy.   "
148617|NCT01338987|"     Background:        -  One way to treat certain cancers of the blood and immune system is to give a patient          stem cells from the bone marrow of a donor whose genes are very similar but not          identical to the patient s. One problem with these transplants is that the new immune          cells may not work as well in the recipient as they did in the donor. The result may be          that the immune system will not work as well. This can increase the risk of severe          infections and other complications.        -  Researchers are studying the use of drugs that lower hormone levels and may allow the          immune system to recover in a way that improves white blood cell function. In this study          they will be looking at the drug lupron, a drug that lowers estrogen or testosterone          levels, to see if it might improve the function of the newly transplanted cells.      Objectives:        -  To determine whether lupron improves immune system function after bone marrow          transplantation from a donor with similarities in their immune cells (matched to each          other).        -  To evaluate the effectiveness of a nuclear medicine test with a radiotracer drug FLT in          imaging studies. FLT will be used to image the immune system function in patients who          have received bone marrow from the donor.      Eligibility:        -  People between 15 (or as young as 9 in those who have gone through puberty) and 40 years          of age. These patients must have acute myelogenous leukemia, acute lymphocytic leukemia,          or high-risk myelodysplastic syndrome. They must also be eligible for a bone marrow          transplant.        -  Genetically similar donors for the patients who are eligible for a transplant.      Design:        -  People taking part in the study will be screened with a physical examination, medical          history, blood and urine tests, and imaging studies. Patients who are not in remission          or who require a bone marrow donor search may receive chemotherapy first.        -  Donors will provide bone marrow for transplant according to standard bone marrow          transplant (BMT) procedures.        -  All women and half of the men will receive regular lupron doses 2 weeks before BMT to          suppress hormone function.        -  All recipients will receive 4 days of radiation followed by 2-4 days of chemotherapy          before the bone marrow transplant (depending on age). Recipients will also receive other          drugs to prevent transplant rejection and other complications of transplantation.        -  Recipients will be monitored in the hospital for 4 weeks after transplant with blood          tests and other studies.        -  Some recipients will have an imaging study with FLT during the protocol. These imaging          studies will take place before the transplant, on days 5 and 28 after transplant, and at          a later time to be determined by the study researchers.        -  Following discharge, participants will be monitored closely for up to 6 months, with          regular but less frequent followup visits for at least 5 years. Study-related          medications, including vaccinations for the new immune system, will be provided by the          National Institutes of Health during the hospital stay and after discharge.   "
148618|NCT01338974|"     RATIONALE: Studying samples of blood and tissue from patients with cancer treated with     cytarabine in the laboratory may help doctors learn more about the effects of cytarabine on     cells. It may also help doctors understand how well patients respond to treatment.      PURPOSE: This research trial studies biomarkers associated with response to cytarabine in     samples from older patients with acute myeloid leukemia.   "
148646|NCT01338610|"     The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing     the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale     (VAS) discomfort score.   "
148621|NCT01338935|"     The purpose of this study is to test the safety and efficacy of an investigational     neuromuscular blocking agent called CW002 and to document its effects on healthy adult     volunteers. A neuromuscular blocking agent is a drug that temporarily prevents muscles from     moving. CW002 has not yet been approved by the Food and Drug Administration (FDA).      Usually, neuromuscular blocking agents are used together with other drugs that put people     completely asleep. These drugs allow doctors to place a breathing tube in the airway, stop     muscles from moving during surgical operations, and allow ventilation (movement of air).      This research is being done because CW002 is expected to act quickly and to provide a muscle     block of intermediate (not too long, not too short) duration. The researchers would like to     test increasing doses of CW002 that can be given without causing severe side effects. If     shown to be both safe and effective, such a compound would be useful in surgical procedures     and could improve future anesthetic care.   "
148622|NCT01338922|"     The effect of change in diabetes treatment from multiple daily insulin injection therapy to     continuous subcutaneous insulin infusion on psychosocial outcome measures (quality of life,     diabetes burden, parents stress level, fear, family conflicts) in families with children and     adolescents with diabetes mellitus type 1 will be analysed. Additionally the effect on     metabolic parameters (HbA1c, severe Hypoglycemia, Ketoacidosis) will be analysed.   "
148623|NCT01338909|"     This is a single-center, randomized, single-blind, investigator-initiated, pharmacological     study with a parallel design. Patients with ST elevation myocardial infarction undergoing     primary percutaneous coronary intervention and presenting high platelet reactivity as     assessed with the Verify Now P2Y12 assay-Accumetrics(Platelet Reactivity Units -PRU≥235) at 2     hours post-clopidogrel 600mg LD (Day 0), as assessed with the Verify Now P2Y12 assay, will be     randomized after informed consent, in a 1:1 ratio to the following treatment groups:      Group Α: Clopidogrel 150mg per day,starting from Day 1 until Day 5 (5 days after     randomization) Group Β: Prasugrel 60 mg immediate loading (on Day 0) followed by 10mg/day     starting from Day 1 until Day 5 (5 days after randomization).      Platelet reactivity assessment will be performed 2 hours after randomization (Day 0), 24 h     after randomization (Day 1) and on Day 5. Documentation of major adverse cardiac events     (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and     serious adverse events (bleeding, other adverse events)will be performed until Day 5.   "
148624|NCT01338896|"     The primary objective of the study is to compare the adhesiveness of two different patch     formulations of rotigotine using patch size 40 cm2, under the assumption that both patch     formulations show similar adhesiveness properties.   "
148625|NCT01338883|"     This is a randomized, double-blind, double-dummy, 48-week, comparative study. Approximately     150 HIV-infected, treatment-naïve patients with CCR5-tropic virus will be stratified by HIV-1     RNA: ≥100,000 copies/mL versus <100,000 copies/mL and will be randomized 2:2:1 to receive:        -  Arm A: CVC 100 mg (2 tablets, 50 mg each) QD + CVC matching placebo (2 tablets) QD + EFV          matching placebo (1 tablet) QHS + FTC/TDF (1 tablet) QD.        -  Arm B: CVC 200 mg (4 tablets, 50 mg each) QD + EFV matching placebo (1 tablet) QHS +          FTC/TDF (1 tablet) QD.        -  Arm C: CVC matching placebo (4 tablets) QD + EFV 600 mg (1 tablet) QHS + FTC/TDF (1          tablet) QD.      Doses of both CVC/placebo and EFV/ placebo will be administered as double-blinded study drug.     FTC/TDF will be administered as open-label study drug in a fixed-dose combination formulation     (Truvada). CVC/placebo should be taken following breakfast; EFV should be taken on an empty     stomach at bedtime.      HIV-1 RNA levels and CD4+ and CD8+ cell counts, percentages, and ratios will be measured at     every visit. Samples for viral tropism and resistance testing in case of virologic failure     will be collected at Screening and each on-treatment visit.      Biomarkers associated with inflammation and immune activation will be measured at Baseline     (predose) and each study visit thereafter, with flow cytometry obtained at weeks 4, 12, 24,     48, and 52.      Fasting metabolic indicators of glucose control (glucose and insulin for HOMA-IR, HbA1c) and     fasting lipid profiles (HDL, LDL, total cholesterol, and triglycerides) will be measured at     Baseline (predose) and Weeks 4, 12, 24, 48, and 52. Waist-to-hip ratios will be measured at     Baseline and Weeks 24 and 48.      Plasma samples will be collected and stored for possible future studies at Baseline (predose)     and every visit thereafter.   "
148626|NCT01338870|"     B2611003 is designed to study how safe and effective an investigational medication     (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6     treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug,     and another treatment will be placebo, which does not contain active ingredient.   "
148627|NCT01338857|"     The purpose of this study is to determine if a drug called sorafenib can shrink LGA tumors     (low-grade astrocytomas) in children and adults. Previous research has given us a better     understanding of this type of tumor by studying the genetic make-up of LGAs. From this     research, the investigators found that a drug called sorafenib may stop the growth of tumor     cells by blocking some of the molecules needed for cell growth and by blocking blood flow to     the tumor. This trial is studying how well sorafenib works in treating patients with LGAs,     and how the effects relate to the specific genetic make-up of your particular tumor. This     testing of your tumor's genetic make-up is optional and requires available tumor tissue for     testing. In summary, the aims of this study are: To see if sorafenib can shrink LGAs; how     well sorafenib is tolerated in patients with LGAs; and, how the effects of sorafenib relate     to the genetic make-up of individual LGAs (Optional Study)   "
148753|NCT01337063|"     Patients often have problems after they leave the hospital, in part because errors are made     in the medications they are prescribed. The goal of this project is to develop a more     accurate and safe medication prescription process when patients enter and leave the hospital     and implement this process at six U.S. hospitals. The investigators will measure the success     of the project and develop lessons learned so this process can be applied to other hospitals.   "
148628|NCT01338844|"     Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various     stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted     Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI).      The hormonal control of multiple follicular growth and maturation is a critical part of ART     procedures since it maximizes the yield of embryos to be transferred, thus increasing the     cumulative pregnancy rate.      Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and     highly effective treatment in order to improve oocyte quality in patients undergoing IVF.     Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable     predictor of oocyte quality. High MI concentration in the FF directly correlates with high     oocyte and embryo quality.      Another stereoisomer of Inositol was successfully used into clinical practice     D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in     hyperglycemic PCOS patients.      In the present study we aim to compare MI versus DCI supplementation on oocyte quality of     women undergoing IVF-ET   "
148647|NCT01338597|"     The purpose of this study is to investigate whether reduced subcutaneous dissection area     could offer patients more clinical benefits.   "
148632|NCT01338792|"     This phase II trial studies how well giving oxaliplatin and pemetrexed disodium together     works in treating patients with refractory hormone-resistant prostate cancer. Drugs used in     chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     oxaliplatin together with pemetrexed disodium may kill more tumor cells.   "
148633|NCT01338779|"     The purpose of this multi-center (observational) registry study is to establish a database of     clinical and laboratory information that may help to identify any unique characteristics of     tolerant participants that differ from participants who reject their kidney after     discontinuing immunosuppressive drugs.   "
148634|NCT01338766|"     The purpose of this study is to evaluate the clinical performance of a decompression using     the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable     grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55%     positive response rate.   "
148635|NCT01338753|"     The purpose of this study is to compare the association between image and certain molecular     markers with complete response in patients with locally advanced breast cancer, treated with     neoadjuvant chemotherapy composed of Bevacizumab, Docetaxel and Doxorubicin.   "
148636|NCT01338740|"     Switching to Adalimumab has proven to be efficacious in Crohn's disease (CD) patients with     intolerance or loss of response to Infliximab. Currently there are no studies on the efficacy     of switching to Infliximab in patients with loss of response or primary non-response to     Adalimumab. Even in rheumatology, where switching between all classes of anti-TNFα     biologicals is common practice, there are no scientific data on switching from humanized to     chimeric anti-TNFα antibodies.      The purpose of this study is to document the efficacy of such a switch and to identify the     possible predictive factors for success.      If treatment with Adalimumab fails (despite optimal dose and interval) and the treating     physician therefore decided to switch to infliximab, the patient may be enrolled in this     observational study. At regular intervals (every Remicade), the patient will be clinically     re-evaluated. The disease activity score will be calculated: Crohn's disease activity index     (CDAI). At regular intervals, the results of interim blood tests will be documented (3x). The     succession will be 1 year. At week 10, 26 and 52, additional serum samples will be taken for     determination of antibodies against Adalimumab and Infliximab. The serum levels of Adalimumab     (week 0) and Infliximab (week 10, 26 and 52) will be determined.      For this study there is no specific therapy change. The study wants only to document the     results of a therapy switch that, in current clinical practice, is made by the treating     physician.   "
148637|NCT01338727|"     The primary objective of this study is to evaluate the efficacy of a specialized exclusive     breastfeeding education and support program targeting obese, pregnant, low-income women in     Hartford, CT. Specifically, the investigators will evaluate the impact of the intervention on     exclusive and partial breastfeeding rates at birth, 1, 3 and 6 months pp. Secondary aims of     this study are: a) to characterize postpartum weight loss patterns and blood pressure values     of obese women, by study group; and b) to evaluate potential differences in infant morbidity     (diarrhea, otitis media and rehospitalization), by study group.   "
148638|NCT01338714|"     The aim of the study is to examine whether the compound herbal formula (RHD-1) is effective     on HBV Carrier With Abnormal Liver Function.   "
148639|NCT01338701|"     This study investigates whether acupuncture can help to decrease the number and severity of     headaches in people who have Traumatic Brain Injury. The aim of this study is to compare two     different types of acupuncture—either Traditional Chinese Acupuncture or ear acupuncture—to a     group that receives no acupuncture at all. Acupuncture has been demonstrated to reduce pain,     improve health-related quality of life, prevent migraine headaches, and improve tension and     chronic daily headaches.   "
148640|NCT01338688|"     The investigators want to determine whether TIG influences the formation of tetanus antibody     after simultaneous tetanus vaccination according to age and the time-interval of the last     tetanus vaccination.   "
148641|NCT01338675|"     In this study the investigators plan to use optimal busulfan dose through pharmacokinetic     study in stem cell transplantation of CGD patients.   "
148642|NCT01338662|"     The purpose of this study is to compare the onset time and severity of dyskinesia in     amantadine or Dopamine agonist initial treated groups in Parkinson`s disease.   "
148754|NCT01337050|"     This is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with dose     escalation and designed to define the Maximum Tolerated Dose [MTD] and the Recommended Phase     2 Dose [RP2D].   "
148643|NCT01338649|"     Study objectives are to determine the efficacy, safety and tolerability of bright light     treatment in Parkinson's Disease (PD) patients with daytime sleepiness. Thirty PD patients     will be enrolled and equally randomized to bright light or dim-red light treatment. Objective     (actigraphy) and subjective (sleep logs/scales) sleep measures will be collected through the     baseline and intervention phases of the study. The primary outcome measure will be the change     in the Epworth Sleepiness Scale (ESS) comparing the bright light treatment with dim-red light     treatment. Secondary outcome measures will include the Multiple Sleep Latency Test (MSLT),     global Pittsburgh Sleep Quality Index (PSQI) score, Parkinson's Disease Sleep Scale (PDSS)     score, and actigraphy measures. A variety of exploratory analyses will examine the effects of     bright light treatment on fatigue, depression, quality of life, cognition, and motor     disability.      Hypothesis: Bright light exposure will diminish daytime sleepiness and improve night-time     sleep in PD patients with daytime sleepiness.   "
148644|NCT01338636|"     The purpose of this study is assess whether ambrisentan can help people with exercise-     induced pulmonary arterial hypertension (EIPAH). The investigators also want to find out if     ambrisentan is safe to take without causing excessive side effects.   "
148645|NCT01338623|"     The purpose of this study is to compare the bioavailability (rate and extent of absorption)     of two tansulosine 0,4 mg capsule formulations. An open, randomized, two-period crossover     study with a seven-days washout interval was conduced in 32 healthy male volunteers. The     plasma samples were obtained up to 72 hours after drug administration. A sensitive and     specific LC-MS/MS method was developed and validated for the determination of tansulosine in     human plasma. Bioequivalence between the products was determined by calculating 90%     confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.   "
148648|NCT01338584|"     Urinary incontinence after radical prostatectomy is a significant clinical problem despite     advances in surgical techniques. In the literature, the incidence of post prostatectomy     urinary incontinence varies widely from 0.5 to 87% (Parekh et al, 2003). Various reasons are     held responsible for this wide discrepancy, including surgical technique, definition of     incontinence, time of evaluation, pathological stage, and patient age. The etiology of post     prostatectomy urinary incontinence has been attributed to sphincteric deficiency, either from     injury of striated muscle fibres or the innervating nerve fibres (Koelbl et al 2002). The     effect of urinary incontinence on the quality of life in these patients has been subject to     debate (Litwin et al, 1995; Braslis et al, 1995). For many patients, however, early recovery     from urinary incontinence has been a major concern (Moore et al, 1999), especially in younger     patients.      Various treatment modalities for post prostatectomy urinary incontinence have been     introduced, including conservative managemnt such as pelvic floor muscle training,     pharmacological treatment and surgical treatment. However, surgery is an invasive procedure     and it's usually be the last resort. Although the Cochrane Incontinence Group (2007)     commented on the need for ongoing research to clarify the role of pelvic floor muscle     training, it is still the first-line treatment used to restore pelvic floor or bladder     function after radical prostatectomy (MacDonald et. al., 2007). Currently, patients learned     pelvic floor muscle training on the day of admission for surgery by ward staff in HA     hospitals of Hong Kong. Subsequently, after removal of urethral catheter, patients will     attend the nurse-led clinic for reassessment and reinforcement of pelvic floor muscle     training. The continence rates which defined as zero pad were 69%, 78.7% and 88.9% at 3     months, 6 months and 12 months respectively (Tam and Ho et al., 2010). In order to determine     the efficacy of intensive preoperative pelvic floor muscle training to decrease     post-prostatectomy urinary incontinence, a randomized controlled trial will be conducted.     Participants in the intervention group would start the pelvic floor muscle training 3 weeks     before surgery provided by an urology nurse specialist whereas the control group would start     the pelvic floor muscle training on the day of admission for surgery provided by ward staff.     Measurement on the grams of urine loss, sense of self control in urination and quality of     life are collected on 4, 8, 12 and 24 weeks after surgery for comparison between the two     groups.   "
148649|NCT01338571|"     This is a pilot study and will be used to power an NIH grant application on the effect of     resistant starch on weight gain in children.   "
148650|NCT01338558|"     This randomized, open-label study will evaluate the safety and efficacy of Avastin     (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage     IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be     assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each     2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in     addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease     progression or unacceptable toxicity occurs.   "
148651|NCT01338545|"     This observational study will evaluate the dosage patterns, safety and efficacy of     RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe     rheumatoid arthritis who have not responded or are intolerant to at least one     disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from     each patients for 12 months.   "
148652|NCT01338532|"     The purpose of this study is to evaluate the time to total hip replacement in patients with     hip osteoarthritis going through both a supervised exercise program and patient education     compared to patients going through patient education only.      The null hypothesis is: There are no differences in time to total hip replacement between     patients with hip osteoarthritis who went through a 12 week supervised exercise program and     patient education compared to patients who went through patient education only.      Material and methods:      109 patients with both symptomatically and radiographically verified hip osteoarthritis were     included in this randomized controlled trial between april 2005 and october 2007. They were     randomized to either a 12 week supervised exercise program and patient education (n=55) or     patient education only (n=54).      Information on if and when total hip replacement is performed will be collected between April     1st and May 1st. Time since inclusion to follow-up will range from 3.5 to 6 years. Data will     be collected directly from the study participants by telephone.      The main outcome is time to total hip replacement.      Status:      This study is a prolongation of an on-going RCT (3a-2005-NAR) using clinical outcomes to     evaluate the effect of supervised exercise and patient education.      The study will be carried out: NAR-Department of Orthopedics, Ullevaal University Hospital.   "
148653|NCT01338519|"     All newly referred patients with PCOS and hirsutism are listed in a database.   "
148755|NCT01337037|"     The purpose of this study is to modify the surgical technique of VATS (video-assisted     thoracoscopic surgery) lobectomy for early-stage non-small cell lung cancer.   "
149111|NCT01332357|"     The objective of this study is to compare readmission to the emergency department for asthma     in asthma patients who receive treatment with fluticasone propionate and salmeterol oral     inhaler after an initial emergency department visit using a retrospective observational     cohort study design.   "
148654|NCT01338506|"     In comparison to the general population, U.S. military and Veterans are at an increased risk     for developing both substance use disorders (SUD) and Post Traumatic Stress Disorder (PTSD).     Current research has shown that there is a high comorbidity of SUD and PTSD, and although     there are a number of treatments for SUD and PTSD independently, there are very few effective     methods to simultaneously treat both disorders. Because of this substantial gap in the     treatment of both SUDs and PTSD, it has become essential to develop a combined treatment that     would address and treat both disorders. Individuals, specifically U.S. military and Veterans,     with SUD/PTSD have unique needs that require a specialized treatment approach. This designed     approach would employ cognitive-behavioral therapy (CBT) to treat the SUD, in conjunction     with Prolonged Exposure therapy to treat the PTSD. Prolonged Exposure (PE) is an empirically     supported and evidence-based treatment that is currently regarded as the gold standard     psychosocial treatment for PTSD. In combination with CBT, this treatment would address both     disorders in hopes of reducing substance use and PTSD symptomatology.   "
148655|NCT01338493|"     The primary purpose of the study is to document the reduction of disability after Maverick     total disc replacement surgery in a 'real-world' patient population requiring disc     replacement.   "
148656|NCT01338480|"     This study is planning to develop the audiovisual videos and determine whether educational     videos are superior to routine discussion for informing trauma patients in emergency     department (ED) about risks, benefits, and alternatives to receiving surgery.   "
148657|NCT01338467|"     The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment     using High Intensity Focused Ultrasound in refractory glaucoma patients.   "
148698|NCT01337791|"     Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic     hepatitis B patients with few adverse effects, but its use during pregnancy has not been     explored. In this open-label, prospective study from the second trimester to post-partum week     28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg     Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated     alanine aminotransferase levels.   "
148658|NCT01338454|"     Obstetrical hemorrhage accounts for nearly one quarter of all maternal deaths worldwide and     was the most common cause of maternal death in the Turkey [1,2]. Most of these deaths occur     within 4 h of delivery and are a result of problems during third and fourth stages of labor.     It also contributes significantly to serious maternal morbidity. Obstetric, surgical and     radiological interventions play central role in the management of obstetric hemorrhage;     however, pharmacologic management and in particular prohemostatic therapies also play an     important role in the final maternal outcome. Administration of tranexamic acid (TA),     intravenously in the third stage of labor may be one of these methods.      TA a synthetic derivate of the amino acid lysine, is an antifibrinolytic that reversibly     inhibits the activation of plasminogen, thus inhibiting fibrinolysis and reducing bleeding.     TA may enhance the effectiveness of the patient's own hemostatic mechanism [3,4]. In     nonobstetric surgery, a systematic review of randomized controlled trails showed that     tranexamic acid reduced the risk of blood transfusion [ relative risk (RR) 0.61; 95% CI     0.54-0.69] and also reduced the need for re-operation as a result of bleeding (RR 0.67; 95%     CI 0.41-1.09). There was no evidence for an increased risk of thrombotic events [5].      In gynecology and obstetrics, TA is most commonly used to treat idiopathic menorrhagia, and     is an effective and well-tolerated treatment when administered orally [5,6,7]. Bleeding     associated with pregnancy (placental abruption, placenta previa) has also been treated with     TA [6]. Furthermore, four randomized controlled studies have shown that TA reduces postpartum     hemorrhage (PPH) following cesarean delivery [7-11]. Only one randomized trail is available     evaluating the effect of TA use to prevent bleeding in the postpartum period following     spontaneous vaginal delivery [12].      The purpose of our study was to estimate the effect of the addition of intravenous TA to a     standard active management of the third stage of labor (which includes prophylactic injection     of 10 IU of oxytocin within two minutes of birth, early clamping of the umbilical cord, and     controlled cord traction).   "
148659|NCT01338441|"     The study main objective is to assess the changes in the ventricular repolarization (measure     by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify     subjects with extreme responses and collecting their skin and blood samples.   "
148660|NCT01338428|"     More than one in six women will be sexually assaulted in their lifetimes, most by men they     know. The risk of sexual assault by men is greatest for girls and women between the ages of     14 and 24 making this a critical time for intervention. Sexual assault has many immediate and     long-term negative consequences for victims. Even a small increase in the ability of women to     resist sexual assault will result in a substantial improvement in the mental and physical     health of women. Recent research has suggested that many young women delay their resistance     to unwanted sexual advances because they are not sure that they are reading the situation     correctly, they do not want to hurt the man's feelings, or they are unsure whether they have     the right to say no to some sexual activity and say yes to other activity. Earlier work from     the researchers resulted in the development of a program affecting these critical areas. This     program was shown to be effective in helping participants build skills and a knowledge base     to help them resist sexual assault and to prepare them for better recovery following sexual     assault. The randomized controlled trial (RCT) builds on this prior work. We will establish     whether the demonstrated short term effectiveness of this theoretically and empirically sound     rape resistance intervention for university women extends to longer periods. We will     determine whether the program can reduce the one year incidence of sexual assault by 30%     among women attending Canadian universities. The results will also be used to indicate how     long the effects of the program last and will indicate at which point in time refresher     sessions may be necessary. A lay summary of the findings of the trial with a focus on     application will be provided to all Canadian universities and to Provincial/Territorial     Ministries of Education. This will be followed up with contact with those most likely to be     involved in current campus education efforts.   "
148661|NCT01338415|"     The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety,     tolerability and efficacy of the pediatric formulation of bosentan two versus three times a     day in children with Pulmonary Arterial Hypertension (PAH).   "
148662|NCT01338402|"     The purpose of this study was to assess the ocular response to and performance of the     cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK®     COLORBLENDS.   "
148663|NCT01338389|"     Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable     results in causing tumor regression while preserving the eye. Optic neuropathy has emerged     consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No     neuroprotective strategies are available at present.      Citicoline is a choline agent precursor available as a dietary supplement. Citicoline     conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models.     In ophthalmology, citicoline has demonstrated a significant action in improving retinal and     cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic     neuropathy). Citicoline also exhibits a very low toxicity profile in humans.      The purpose of the study is to demonstrate whether daily oral administration of citicoline in     patients treated for uveal melanomas with proton beam therapy, prevents or delays the     occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual     evoked potentials are measured. The tolerability/safety of the product is also evaluated.   "
148664|NCT01338376|"     Diabetes is a common, costly condition associated with significant morbidity and mortality.     Diabetes self-management education, the process of teaching individuals to manage their     diabetes, has been considered an important part. The intensive education has the capacity to     deliver effective interventions to a large number of people. The investigators may be able to     redirect our efforts to diabetes care and education strategies that will have a positive     impact on the optimization of glycemic control and the prevention of long-term complications     of diabetes, reducing the subsequent human and health care costs.   "
148665|NCT01338363|"     The purpose of this study is        1. To describe patient characteristics and drug usage among children that are prescribed          esomeprazole for the first time and to compare them with patients who are prescribed          other proton pump inhibitors (PPIs) or H2-receptor antagonists for the first time.        2. To ascertain all incident hospitalized cases of angioneurotic oedema, pneumonia,          gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis          and thrombocytopenia among new users in the three cohorts of esomeprazole, other PPIs          and H2-receptor antagonists.   "
148666|NCT01338350|"     The purpose of this study is to assess safety, tolerability, pharmacokinetics and     pharmacodynamic effects (24-hours plasma cortisol area under curve, plasma cortisol pre and     post ACTH stimulation, dehydroepiandrosterone sulphate (DHEAS), osteocalcin and 24 hours     urine cortisol) of AZD5423 following administration of single and multiple ascending doses in     healthy male Japanese subjects.   "
148693|NCT01337856|"     This is a randomized controlled trial comparing the effectiveness of three hand hygiene     protocols, during routine inpatient clinical care: Protocol 1: handrubbing with alcohol     covering all hand surfaces in no particular order; Protocol 2: handrubbing with alcohol using     the WHO standard 7-step technique; and Protocol 3: handwashing with chlorhexidine using the     WHO standard 7-step technique.      The main study hypothesis is that alcohol hand-rubbing covering all hand surfaces is not less     effective in reducing bacterial hand contamination of healthcare staff than alcohol     hand-rubbing using 7-step technique; and is more effective than chlorhexidine handwashing.     The secondary study hypothesis is that time spent on alcohol hand-rubbing covering all hand     surfaces is less than that required by the other 2 hand hygiene protocols respectively.   "
148667|NCT01338337|"     Primary Outcome Measures:      • To evaluate the efficacy of treatment with Azacitidine in patients with     transfusion-dependent, low risk International Prognostic Scoring System (IPSS) 0 int-1,     Myelodysplastic Syndrome (MDS) without chromosome 5 (5q) deletion. The main objective will be     based on the erythroid haematologic response according to International Working Group (IWG)     2006 criteria.      Secondary Outcome Measures:        -  Haematologic response, bases on the following parameters: platelets, and neutrophils          according to International Working Group (IWG) Criteria.        -  Medullary and cytogenetic response according to International Working Group (IWG) 2006          criteria.        -  The effect of treatment response on quality of life, through the Functional Assessment          of Cancer Therapy-Anemia (FACT-an) questionnaire.        -  Overall survival, Event-Free Survival and the Acute Leukaemia Transformation Rate.   "
148668|NCT01338324|"     The small bowel biopsy is the cornerstone of for the diagnosis of celiac disease. In addition     to being the gold standard for the initial diagnosis of celiac disease, periodic biopsies are     also recommended on an ongoing basis for this life-long disease. However, biopsy evaluation     is invasive and expensive. Therefore, there is a need for simple, non-invasive tests that can     be performed on celiac patients with subclinical disease.      The present study is based on the hypothesis that the expression and activity of cytochrome     P450 CYP3A4 in the small intestinal mucosa is a sensitive measure of enteropathy. Therefore     small intestinal CYP3A4 activity will be markedly different in celiac disease patients with     active disease as compared to patients in remission. Small intestinal CYP3A4 activity will be     measured in three ways:      (i) Cmax of oral simvastatin, a widely used drug that is predominantly metabolized by small     intestinal CYP3A4; (ii) AUC of oral simvastatin; and (iii) Measurement of CYP3A4 activity in     two small bowel biopsies.   "
148669|NCT01338311|"     Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness     (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the     long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The     onset of tolerance to salbutamol is not known.   "
148670|NCT01338298|"     Prolactin is a hormone that naturally occurs in the body. Some women taking antipsychotic     medications may have high levels of prolactin in their bodies. High levels of prolactin may     cause women to have problems with sex or satisfaction from sex. It may also cause women to     have fewer or no menstrual periods. It may also cause the production of breast milk and may     contribute to long term bone loss.      In this study, the investigators are testing whether taking adding a low dose of an     antipsychotic medication called aripiprazole may help improve high prolactin levels and help     with sexual dysfunction or problems with menstrual periods. The investigators are also     looking to see if it may slow the loss of bones. This medication has been shown to be helpful     for improving symptoms of schizophrenia.   "
148671|NCT01338285|"     Background:        -  Research suggests that occupational exposure to formaldehyde is associated with          increased risk for myeloid leukemia, but the significance of these findings is uncertain          because of inconsistencies among studies and lack of knowledge of how formaldehyde can          cause leukemia.        -  Damage to the DNA of myeloid cells (type of white blood cell) or an environmental factor          not affecting the cell genetic machinery may be involved.      Objective: To determine if formaldehyde exposure is associated with genetic or other changes     in myeloid cells.      Eligibility: Workers exposed to high levels of formaldehyde and unexposed workers in     Guangdong Province, China.      Design:        -  40 exposed workers and 40 unexposed workers will be enrolled.        -  Subjects wear small instruments at work that measure chemicals in the air for 1 or 2          days.        -  Subjects have a brief physical examination and provide blood, urine, and mouth rinse          samples.        -  Subjects answer a questionnaire about work, smoking and drinking, use of medicines,          medical history, general health, exposure to radiation and exposure to various          substances at home.   "
148672|NCT01338142|"     The study objective is, to evaluate the fractional absorption of calcium from amorphous     calcium carbonate (ACC) Vs crystalline calcium carbonate (CCC) dietary supplements in     postmenopausal women.   "
148673|NCT01338129|"     The use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome     (CRPS)   "
148674|NCT01338116|"     Severe bacterial infections are associated with mortality of about 30%. Patients with     moderate to severe bacterial infections given early and appropriate empirical antibiotic     treatment are at a lesser risk for a fatal outcome, with odds ratios ranging from 1.6 to 6.9.     However only about 2/3 of patients worldwide are given early and appropriate empirical     antibiotic treatment. About 40% of patients treated with antibiotics are given superfluous     treatment.      TREAT is a computerized decision support system for antibiotic treatment in inpatients with     common bacterial infections. TREAT is based on a state of the art stochastic model of the     domain (a causal probabilistic network) and uses a cost benefit model for antibiotic     treatment, including costs assigned to future resistance. It was tested in a randomized     controlled trial in 3 countries and shown to improve the percentage of appropriate empirical     antibiotic treatment while at the same time reduce hospital stay and the use of     broad-spectrum antibiotics. The main limitation of TREAT is inherent in the limited     information available within hours of presentation.      A second attractive approach to improve antibiotic treatment is to use techniques that do not     depend on cultures, and thus shorten the time to identification of the pathogen to a few     hours only. The LightCycler® SeptiFast test from Roche performs in vitro nucleic acid     amplification test for pathogens causing bloodstream infections.      The purpose of the clinical trial is to show that the combined system TREAT/PCR assays will     improve the outcome of inpatients with moderate to severe bacterial infections, while at the     same time reducing the use of broad-spectrum antibiotics, with no or little additional costs.     A secondary objective will be to assess the sensitivity and specificity of whole blood PCR,     using TREAT as the reference standard.   "
148675|NCT01338103|"     The purpose of this study is to determine whether Rituximab, in the same doses as used in     rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune function     via the Cylex assay in pemphigus patients before and after treatment with RItuximab.   "
148676|NCT01338090|"     This is a pilot study for evaluation of 89Zr-bevacizumab PET imaging as predictive biomarker     during treatment with everolimus in patients with neuroendocrine tumors.      Patients with progressive disease during the last year will receive treatment with everolimus     10 mg/day orally and 89Zr-bevacizumab PET imaging will be performed before start of treatment     and after 2 and 12 weeks of treatment in the first three patients. If the scan after 2 weeks     of treatment is already informative further patients will not undergo a scan at 12 weeks. A     scan is considered already informative if both scans show at least 30% decrease in uptake in     case of response, or at least 30% increase in uptake in case of disease progression.      Four days before the scan patients will be injected intravenously 37 MBq, protein dose 5 mg     89Zr-bevacizumab. At day 1, day 15 and day 99, PET images will be made for visualization and     quantification of VEGF in the tumor lesions and blood will be drawn for determination of     angiogenesis and mTOR pathway related biomarkers.   "
148677|NCT01338077|"     About 60% of patients with typical gastroesophageal reflux symptoms such as heartburn and     regurgitation are considered to have non-erosive reflux disease (NERD). Patients with NERD     show an overall poorer response to PPI treatment than patients with erosive reflux disease.     Sodium alginate oral suspension is a medication indicated for the relief of gastroesophageal     reflux symptoms. This multi-center, double blind, randomized trial aims to compare the     efficacy and safety profiles of sodium alginate oral suspension (50 mg/ml) 20 ml three times     daily with that of omeprazole (20 mg/capsule) 1 capsule once daily for the treatment of NERD     patients in Taiwan. Efficacy assessments include percentage of patients achieving adequate     relief of heartburn or regurgitation after 4 weeks treatment, improvement of reflux symptoms     as assessed by reflux disease questionnaire before and after treatment, and patients overall     satisfaction at the end of study. Safety assessments include incidence of adverse events and     change of the laboratory test results. The study hypothesis is that treatment with sodium     alginate is non-inferior to omeprazole in relieving heartburn or regurgitation symptoms of     the NERD patients.   "
148678|NCT01338064|"     Silicosis is well-known occupational disease caused by free crystalline silica (silicon     dioxide) and is marked by inflammation and pulmonary fibrosis. There are cumulative evidences     that exposure to Caesar stone (quartz surface products that manufactured from up to 93%     quartz, polymer resins and pigments) is particularly dangerous to exposed workers.      Goals: To examine marble workers exposed to Caesar Stone in order to propose a working plan     of surveillance and prevention by biological monitoring.   "
148679|NCT01338051|"     This project will use a community based participatory research orientation to develop a model     for large scale campaign preventive healthcare interventions. The investigators have     considerable expertise with cervical cancer screening and HPV vaccination. The investigators     also have well tested methodologies for cervical cancer screening that are highly effective,     including self-sampling for HPV and improved specimen transport systems. Therefore, the     investigators will use these medical interventions as the model preventive health     interventions for this project.   "
148680|NCT01338025|"     The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC)     alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV     infected children, adolescents and young adults. The study was to see if there were changes     in the HIV virus and if there were differences in immune function, viral load and medication     side effects between the two groups over 28 weeks. Participants were assigned to either take     3TC or FTC alone or continue on his/her current failing HAART regimen. During the first 28     weeks of this study, if the participant was randomized to the continue HAART arm, he/she was     not switched to a different or new, potentially suppressive HAART regimen, but continued on     the current failing HAART regimen. However, if continuing HAART, the participant might be     switched to a new regimen if their provider felt that it was clinically needed or the     participant met certain study endpoints (e.g., drop in CD4, increase in viral load).      At the end of 28 weeks, the participant had the choice of remaining on the assigned study     group medication(s) or starting a new HAART regimen prescribed by his/her doctor. Then, they     would be followed for another 24 weeks to compare the difference in immune function, viral     load and medication side effects between the different groups.   "
148681|NCT01338012|"     Multicenter open label, uncontrolled study that enrolled men with metastatic castrate     resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent     setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up     (LTFU) Phases.   "
148682|NCT01337999|"     The purpose of this study is to determine if Human Epididymis Protein 4 (HE-4) levels vary     during the menstrual cycles in ovulatory women. HE-4 is a sensitive serological marker that     is elevated in certain ovarian and endometrial cancers and can aid in the diagnosis of these     malignant conditions. In order to optimize the utility of HE4 as a tumor marker in     premenopausal women, its expression in the normal menstrual cycle needs to be characterized.     We hypothesize that HE-4 levels do not vary in the menstrual cycle.   "
148683|NCT01337986|"     Fifty subjects will be enrolled in this Phase II, investigator-initiated, randomized and     blinded cross-over trial of dalfampridine of 8 weeks duration The study will test the     hypothesis that dalfampridine, when administered to subjects with incomplete visual recovery     after optic neuritis from MS, will result in symptomatic improvement in visual function. The     study will consist of one screening/baseline visit, one visit during treatment with active     drug, and one visit on placebo. After the baseline visit, subjects will be randomly assigned     to receive study medication or placebo for the first three weeks, followed by a two week     wash-out, and then treatment reallocation for the latter three weeks.   "
148684|NCT01337973|"     The purpose of this study is to examine the impact on both clinical (violence and substance     use) outcomes and health services use (substance use disorder and mental health treatment)     compared to standard SUD treatment (enhanced treatment as usual) of        1. an integrated Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT) violence          prevention treatment intervention delivered during the 8-week early substance use          disorder treatment phase; and        2. MI-CBT plus a continuing care (CC) intervention for the 3-month continuing care period          following the early treatment phase MI-CBT+CC).      The study will provide important new information regarding the role and relative impact of     both early treatment and continuing care interventions designed to impact substance use and     violence, and whether combining such interventions yields additional benefits.   "
148694|NCT01337843|"     This research will evaluate the efficacy of a new online self- help intervention, the     Wellness Workbook, for individuals with chronic low back pain (CLBP). Participants will be     randomly assigned to use the Wellness Workbook or alternative self-help materials and     assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome     measures include pain-related disability and pain severity.   "
148695|NCT01337830|"     Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on     reducing craving for a cigarette in daily smokers.   "
148696|NCT01337817|"     Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen     Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when     tobacco is smoked.   "
148697|NCT01337804|"     This study compares the bioequivalence of omeprazole administered as either Zegerid® powder     for oral suspension 20 mg or as Prilosec 40 mg capsule to healthy participants.   "
148685|NCT01337960|"     Veterans and other Americans who survive stroke often face disabling motor impairments that     impede performance of activities of daily living and limit free-living activity. Prominent     among these are diminished walking and balance functions, which not only foster a sedentary     lifestyle and physical deconditioning, but also increase the risk of injuries due to falls.     Recent research has demonstrated how motor learning based interventions can modify brain     activity and improve motor functions in persons with stroke. Now there is a major research     opportunity to advance the effectiveness of these interventions by applying new robotics     technologies to improve control of essential functions such as gait and balance. One critical     area for performance of walking and standing balance is the control of the ankles, as they     are a major conduit of mechanical power in gait and also modulate torques affecting the     motion of the whole body center of mass when balancing. Thus the current proposal is designed     to investigate two approaches for using an impedance controlled ankle robot to improve gait     and balance among stroke survivors with chronic lower extremity weakness. One approach uses     the ankle robot in a seated visuomotor training program that focuses has subjects play video     games with the weaker ankle to improve paretic ankle motor control that may carry over to     gait and balance functions. The other approach uses task-specific gait training by     integrating use of the ankle robot during treadmill exercise training to assess effects on     the same functions. The effectiveness of both robotics approaches will be compared to that of     a treadmill exercise program without robotics.   "
148686|NCT01337947|"     The principal hypothesis of this study is that the micro and macro vasculature of young     diabetes mellitus type 1 (DM1) patients is particularly susceptible to atherogenic factors     which cause vascular dysfunction at multiple levels of the arterial vasculature and that this     dysfunction is demonstrable using state-of-the-art ultrasound methods. The investigators     further hypothesize that interventions, such as exercise, that are readily integrated into     the daily life of individuals with DM1 can mitigate or reverse these early vascular changes     and thereby diminish the otherwise predictable longer-term development of cardiovascular     disease (CVD) in type 1 DM   "
148687|NCT01337934|"     The use of albumin in critical ill patients is a matter of controversy. A large randomized     controlled trial reported that albumin was as safe and effective as crystalloid solution for     fluid replacement in intensive care unit, although the last one was less expensive. In     Surviving Sepsis Campaign International Guidelines there are no preference for crystalloids     over colloids. But recently, a retrospective analysis of patients with severe sepsis from     SAFE study reported that the use of albumin in these patients would be superior, regarding     reduction of mortality. The aim of this study is determine whether the use of albumin improve     clinical outcomes in patients with severe sepsis or septic shock.   "
148688|NCT01337921|"     The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain     probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34     weeks corrected gestation age (CGA) ; 2) compare infants successfully colonized with     probiotic organisms to infants not successfully colonized at 1, 2, 3, and 4 weeks of life, 34     weeks CGA on infant outcomes and on stress biomarker patterns at birth, day of life (DOL) 1,     DOL 7; 3) determine long-term safety and outcomes of probiotic treatments at 6, 16, and 24     months CGA.   "
148689|NCT01337908|"     This is a study of factors, such as pain, family support, psychological history and     alcohol/substance use, that may influence whether a person experiences depression after their     spinal cord injury.   "
148690|NCT01337895|"     -  Objectives Taking a 'whole foods' approach, we will investigate (i) whether consumption          of isocaloric diets containing ≥4 vs. ≤1 servings of dairy products per day for 16 weeks          results in greater body fat loss in energy-restricted overweight/obese premenopausal          women; (ii) the role of dairy product consumption in influencing physiological and          metabolic factors which may precede or accompany changes in body composition, including          in enzymes which synthesize and break down body fat; and (iii) factors, including          obesity phenotype, which may influence the response of body composition to dairy product          consumption.        -  Background      With the obesity epidemic showing no signs of abating, there is ongoing interest, both at the     lay public and scientific levels, in manipulating the diet to promote weight, specifically     fat, loss. One such promising manipulation is an increase in, or perhaps more precisely, an     isocaloric substitution of, dairy product consumption. The inverse association between Body     Mass Index (BMI) and dietary calcium - for which dairy products are the main source - was     first described in 1984 and has since been supported by various levels of evidence, but not     consistently. Heaney recently described this literature as confused, which he and Rafferty     attribute to important limitations in study design, including lack of low-calcium contrast     groups and the fact that body weight/body composition is often a secondary endpoint in     studies designed and powered for a different outcome, typically bone health or blood     pressure. Confusion has also arisen from the investigation of different interventions (dairy     products, dairy calcium, dietary calcium, supplemental calcium), making it difficult to     compare and interpret studies. This creates an opportunity for the proposed Dairy and Weight     Loss (DAWL) study, with its focus on whole dairy product consumption, to help clear up the     confusion surrounding this issue.      **Hypotheses      Overweight/obese, low habitual dairy consuming, premenopausal women randomized to an     energy-restricted weight loss diet containing ≥4 servings/day of dairy products (milk,     yogurt, cheese) for 16 weeks will lose more body fat than those randomized to an isocaloric     diet containing ≤1 servings/day of dairy products.   "
148691|NCT01337882|"     Exposure to particulate air pollution has been shown to increase cardiovascular mortality and     morbidity, and in previous controlled exposure studies has been shown to have acute     cardiovascular and respiratory effects. The last decade has seen an unprecedented drive     towards finding a bioeconomical and renewable source of fuel in order to reduce our     dependence on fossil fuels. Although both biodiesel and bioethanol have emerged as contenders     for future fuels, biodiesel remains as the strongest contender within European markets. In     2007 researchers at the EPA released a commentary, which concluded that the assumed     correlation between the chemical composition of biodiesel exhaust and a reduction in health     effects was only hypothetical. They suggested that there was a clear need for the study of     health effects in humans regarding biofuel exhaust. In this project the investigators aim to     investigate the cardiovascular, respiratory and inflammatory responses to biofuel exhaust     exposure in healthy volunteers.   "
148692|NCT01337869|"     A pilonidal sinus is a cyst on the natal cleft of the buttocks that often contains hair and     skin debris. The condition is common and requires surgery to be cured. Several surgical     procedures are described in literature. Limberg Flap technique is frequently used technique     for this disease all over the world. However, Bascom Cleft Lift Technique is relatively newer     technique. The purpose of this prospective randomized study is comparison of these techniques     about patient satisfaction for postoperative period.   "
149289|NCT01329991|"     PLX115-02 is a phase 1b study to assess how the study drug, PLX5622: 1. affects the body, 2.     how the body affects PLX5622 3. the interaction of PLX5622 with Methotrexate and 4. the     safety of PLX5622 in rheumatoid arthritis patients taking Methotrexate   "
148699|NCT01337778|"     A growing body of research indicates that gender-based violence (GBV) is a major global     public health challenge. Yet, there is a dearth of evidence to guide program planning and     policy-making efforts to reduce GBV. Our study will evaluate the feasibility, safety, and     potential effectiveness of an innovative women's empowerment intervention to reduce GBV and     related adverse health outcomes. It is expected that the study findings will provide evidence     to determine if a phase 3 effectiveness trial is merited and advance the science underlying     GBV prevention.   "
148700|NCT01337765|"     This is an open label, dose finding, phase Ib clinical trial to determine the maximum     tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in     combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients     with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast     cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other     advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided     by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion     arms will be opened in order to further assess safety and preliminary anti-tumor activity of     the combination of BEZ235 and MEK162.      Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a     treatment cycle is defined as 28 days.   "
148701|NCT01337752|"     The study will evaluate the effects of BHQ880 in patients with previously untreated multiple     myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy.     The primary objective of the study will be to evaluate the effect of BHQ880 in combination     with bortezomib and dexamethasone, compared to placebo administered with the combination on     the time to first Skeletal Related Event (SRE) on study.   "
148702|NCT01337739|"     Patients undergoing deep sedation for outpatient procedures typically receive a combination     of benzodiazepines, propofol, and opioids. Side effects of such anesthetics include     respiratory depression, nausea and vomiting, and urinary retention, with resultant extended     hospital stays and unanticipated admission. The use of dexmedetomidine for deep sedation may     increase patient safety by maintaining respiratory drive, while providing sedation, hypnosis,     and analgesia. Furthermore, patients may experience decreased pain, nausea, and time to     discharge in the PACU, especially if dexmedetomidine decreases the requirement of other drugs     such as opioids.      The hypothesis of this study is administration of dexmedetomidine during deep sedation for     ambulatory hysteroscopic surgery will result in a 50% reduction of intraoperative opioid     compared to sedation with propofol.   "
148703|NCT01337726|"     The purpose of this research study is to test a program developed to help patients with     chronic heart or lung problems take care of themselves and cope with their illness or     limitations.   "
148704|NCT01337713|"     There is an impressive and growing body of data suggesting that massage therapy is effective     in decreasing some symptoms of pathological conditions as well as facilitating growth,     reducing pain, increasing alertness, diminishing symptoms of depression and anxiety, and     enhancing immune function. Preliminary studies suggest that massage therapy decreases     symptoms of anxiety and depression, and lowers salivary cortisol levels in a wide array of     childhood and adult neuropsychiatric disorders including post-traumatic stress disorder,     attention-deficit-disorder hyperactivity, depression, bulimia and anorexia-nervosa.     Generalized Anxiety Disorder (GAD) is characterized by the presence of a constellation of     signs and symptoms for at least 6 months in duration, with some type of functional disability     or decrease in quality of life. The signs and symptoms of GAD include a myriad of somatic     symptoms including muscle tension, headaches, backaches, fatigue, restlessness, insomnia, as     well as psychological feelings of worry, anxiety, and feeling overwhelmed. Both     pharmacotherapy and psychotherapy are effective in decreasing the signs and symptoms of GAD.     Unfortunately, the vast majority of patients with GAD never receive adequate pharmacotherapy     or psychotherapy. Therefore, the development of a complementary and alternative therapy that     has demonstrated efficacy for GAD might be well received by patients.      This study's goals are to investigate the efficacy of Swedish massage therapy vs. light touch     therapy and better understand the biological effects of massage in patients with anxiety.     Qualified participants will be randomly assigned to one of two groups in which they will     receive Swedish massage therapy twice per week for 12 weeks or Light Touch therapy twice per     week for 6 weeks followed by Swedish massage therapy twice per week for the next 6 weeks. The     total length of the study is 13 weeks, which includes a screening visit that takes about 3     hours and two therapy visits per week for 12 weeks that last about 1 hour each. Blood and     urine will be collected at three of the visits. Compensation is up to $400 for completing the     entire study.   "
148756|NCT01337024|"     Heart rate variability (HRV) is an important indicator of cardiac autonomic function and     predictor of cardiac mortality and of all-cause mortality. In this study the investigators     examined changes of the HRV in patients with neurogenic detrusor overactivity (NDO)     undergoing botulinum neurotoxin type A intradetrusor injections (BoNT/A).   "
148705|NCT01337700|"     Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive     Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders     beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates     suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very     substantial costs associated with caring for patients with ASD, and ASD has the highest     Caregiver Burden Scores of any condition. There are three core symptom domains of ASD,     including social deficits, repetitive behaviors and language deficits. Patients can also have     associated symptoms of attentional deficits, disruptive behaviors and intellectual     disability. There is currently no Food and Drug administration (FDA) approved treatment for     the core symptoms of autism, but risperidone and aripiprazole have FDA approval for     disruptive behaviors associated with autism.      This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults     with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and     normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a     role in behavior adaptations and performance.   "
148736|NCT01337297|"     The use of crack-cocaine is growing at alarming rate in our country and it is absolutely     worrisome the fast establishment of addiction to it. Its immediate effects, that are intense     and extremely fleeting, increase dramatically the probability of this drug to be consumed     again, settling quickly down the loss of control and the compulsive use, turning the effects     of this drug highly addictive. Parallel to this process, brain damages are quickly     established, progressing to severe impairments of frontal functions, leading to the lack of     cognitive control that feeds back and aggravates the dependence, and hampers any therapeutic     approach. The existing treatments have not proved to be satisfactory yet. Thus, considering     that a new modality of treatment, based on the neuromodulation induced by noninvasive brain     stimulation, has been useful in treating various neuropsychiatric conditions, this study will     examine the potential beneficial effects of repeated transcranial Direct Current Stimulation     over the left dorsolateral prefrontal cortex in the treatment of crack-cocaine addiction.   "
148706|NCT01337687|"     Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in     speech and communication, impaired social functioning and repetitive behaviors and restricted     interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating     uterine contractions and milk let-down; however, studies, mainly with rodents and non-human     primates, has found that OT is involved in affiliative behaviors, including sexual behavior,     mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of     social attachment. Moreover, OT is known to play an important role in repetitive behaviors     and stress reactivity. Given that repetitive behaviors and deficits in social interaction are     core symptom domains of autism, and that OT is involved in the regulation of repetitive and     affiliative behaviors, it is believed that OT may play a role in the etiology of autism.     Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of     value in treating core autism symptoms. Specifically, synthetic oxytocin administered via     intravenous infusion to adults with autism spectrum disorders (ASD) produced significant     reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind,     placebo-controlled cross-over laboratory challenge.      Encouraged by these findings, the primary aim of this study is to investigate the safety and     therapeutic efficacy of intranasal OT in treating repetitive behaviors and social     functioning/cognitive deficits in adults with ASD. This research embraces a translational     approach to develop a novel treatment for core ASD symptoms; given that there are currently     no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms,     this research addresses an important unmet need in the field. The goal of this study is to     evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment     (INOT)administration in adults with ASD.   "
148707|NCT01337674|"     This study will evaluate the safety and tolerability of MK-4618 when coadministered with     antihypertensive agents and will evaluate changes in blood pressure following     co-administration of MK-4618 with a beta blocker and a vasodilator. The primary hypothesis of     the study is that MK-4618 does not result in a clinically meaningful change in systolic blood     pressure relative to placebo when co-administered with a beta-blocker or with amlodipine.   "
148708|NCT01337661|"     The purpose of this study is to observe how the inflammatory pathways differ in subjects with     chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).   "
148709|NCT01337648|"     The purpose of this study is to develop fecal tests that will determine the extent of     radiation exposure in patients undergoing radiation treatment for cancer. This project will     determine whether fecal biomarkers can be used to diagnose exposure to radiation.   "
148710|NCT01337635|"     Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier,     inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble     vitamin that is primarily acquired through local production in the skin after ultraviolet     light exposure but can also be obtained through natural and supplemental dietary sources.     This randomized controlled trial will examine the effects of vitamin D repletion on atopic     dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize that     pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency will     have improved cutaneous disease after treatment with high dose as compared to standard dose     vitamin D.   "
148711|NCT01337622|"     Checking of gastric residuals prior to the continuation/increase of enteral feeding prolongs     the time to establish full gastric feeding in the early postnatal period.   "
148712|NCT01337609|"     The purpose of this study is to determine the safety and effectiveness of a nutritional     supplement, the probiotic bacteria GanedenBC30. Probiotics are live microorganisms which when     taken in large enough amounts are supposed to provide a health benefit. The investigators     would like to see whether this supplement can be used as a treatment for Irritable Bowel     Syndrome (IBS) and Major Depressive Disorder (MDD). Participants in the study will have both     IBS and MDD. In order to find out if GanedenBC30 is effective in treating IBS and MDD, the     investigators will compare it to a placebo. About 32 people will take part in this research     study. About half of these 32 people will take part at Charles River Medical Associates and     half will take part at Burlington Medical Associates. Participants will be recruited from     among patients already being seen at Charles River Medical Associates or Burlington Medical     Associates for their primary care. The study will last for two months, during which time     participants will make eight study visits and will take either Ganeden BC30 or placebo. The     investigators hypothesize that subjects treated with the probiotic will have significantly     better outcomes with regard to depression and IBS symptoms compared to those who receive     placebo.   "
148713|NCT01337596|"     To evaluate the safety and tolerability of LY2951742 given as a single or multiple     subcutaneous injection in healthy male subjects   "
148714|NCT01337583|"     This is a double-blind, randomized, placebo-controlled Phase III study to asses the safety     and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.   "
148715|NCT01337570|"     This is a double-blind, randomized, placebo-controlled Phase III study to assess the safety     and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.   "
148716|NCT01337557|"     The purpose of this study is to assess if BEPREVE (bepotastine besilate ophthalmic solution)     1.5% will have an effect on contact lens wear in patients with contact lens intolerance due     to allergic conjunctivitis.   "
148757|NCT01337011|"     This is a pilot study comparing the effect of intra-coronary versus intramyocardial     application of enriched CD133pos autologous bone marrow derived stem cells for improving left     ventricular function in chronic ischemic cardiomyopathy.   "
149112|NCT01332344|"     The objective of this study is to compare healthcare utilization and costs in asthma patients     who receive fluticasone propionate/salmeterol combination 100mcg/50mcg (FSC 100/50) or     inhaled corticosteriods in typical clinical practice using a retrospective observational     cohort study design of large managed care database.   "
148734|NCT01337323|"     This study is a prospective observational cohort study with 3-month follow-up among a cohort     of intranasal steroid (INS) -experienced patients newly starting fluticasone furorate nasal     spray (FFNS). The primary aim is to examine the effect of FFNS on the use and associated cost     of concomitant allergic rhinitis medications in INS-experienced patients starting treatment     with FFNS who have a history of prior concomitant medication use. The secondary aim will be     to determine the effect of FFNS on control of allergic rhinitis, as assessed by the Rhinitis     Control Assessment Test (RCAT).      Adult patients filling a new FFNS prescription will be recruited (within 4 days of starting     their FFNS) across 50 branches of a retail pharmacy chain with co-located convenient care     clinics. Approximately 350 patients who have active seasonal rhinitis and have used an INS     other than FFNS and another prescription or over-the-counter allergy medication in the     previous allergy season will be eligible for the study. A baseline questionnaire will be     administered to collect information on patient demographics, a brief medical history of the     patient's rhinitis, prior use of INS and other prescription and over-the-counter medications     taken for allergic rhinitis, total out of pocket costs for the prior allergy season, number     of office visits due to allergic rhinitis, and level of control of symptoms of allergic     rhinitis.      At 1, 2, and 3 months post-enrollment, a follow-up questionnaire will be administered to     collect information on medications taken for allergic rhinitis, office visits due to     rhinitis, and level of control of symptoms of allergic rhinitis. In addition, pharmacy claims     data will be abstracted for patients 1 year prior to enrollment and 4 months after enrollment     to verify and supplement patient reported data as needed.      The primary outcomes will be rate of use of non-INS concomitant medications (frequency and     duration) at baseline, and 1, 2, and 3 months follow-up and change in rate of use of non-INS     concomitant medications (post vs. pre and from baseline to 3 months follow-up). Secondary     outcomes will be change in total allergic rhinitis pharmacy expenditures (post vs. pre and     from baseline to follow-up) and change in the level of control of allergic rhinitis, as     measured by score on the Rhinitis Control Assessment Test (RCAT), from baseline to follow-up.   "
148717|NCT01337544|"     The investigators propose a new antitumor cell therapy for treating childhood refractory     solid tumours. The aim of this study is explore the graft versus tumour effect mediated by     allogenic natural killer cells (NKs). NK cell alloreactivity can be predicted by donor killer     immunoglobulin-like receptors (KIRs) and human leukocyte antigen (HLA) class I alleles     mismatch. Cells without an inhibitory HLA ligand may trigger natural killer cell activation     and elimination of those target cells. Reduced risk of relapsed has been described in     malignant cancer after haploidentical stem cell transplantation when HLA ligands against the     inhibitory KIRs present in the donor were absent in the recipient (KIR-HLA receptor-ligand     mismatch). NK alloreactivity could also be obtained by Natural Killer Receptor (NCR),     Toll-Like-Receptors (TLRs) and NKG2D receptor stimulation mediated by cytokines or tumour     cell lines.      This will be an open, non randomized, Phase I/II clinical trial, with a double objective:     therapeutic exploratory. The investigators aim at studying safety and efficacy of     haploidentical stem cell transplantation for the treatment of these malignancies with no cure     known. Patients will receive an haploidentical stem cell transplantation, followed by IL-15     stimulated NK cells infusion one month after transplantation. Efficacy of the procedure will     be evaluated with up-to-date radiological techniques, molecular studies and functional     assays.   "
148718|NCT01337531|"     Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when     either recombinant or highly purified follicle stimulating hormone (FSH) is used.   "
148719|NCT01337518|"     This study will evaluate an experimental drug called EZN-4176 to determine the anticancer     effects when it is given to patients with an advanced form of prostate cancer called     castration-resistant prostate cancer (CRPC). Goals of this phase I study include finding out     the dose of EZN-4176 that can be safely given without serious side effects and to determine     the amount of EZN-4176 that should be given in future studies.   "
148720|NCT01337505|"     This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated     dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450     mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous     infusion on Day 1 every 21 days for up to 6 cycles.   "
148721|NCT01337492|"     Patients with either histological confirmation or clinical diagnosis who are candidate for     orthotopic liver transplant(OLT) will receive Sorafenib 400mg 2 x day (BID) as a neoadjuvant     (bridging) treatment until transplant. If patient progresses or falls outside of the Milan     criteria on sorafenib patient can be treated per physician's discretion using local therapy.     Patient will be followed until 30 days after the orthotopic liver transplant (OLT).   "
148722|NCT01337479|"     The purpose of this study is to follow patients treated in entecavir Phase III and rollover     studies for safety experience and Hepatitis B virus (HBV)-related complications.   "
148723|NCT01337466|"     This protocol will evaluate the biodistribution and dosimetry of [124I]FIAU in both healthy     volunteers and patients with prosthetic joint infections. This pilot study will also     investigate the safety and tolerability of [124I]FIAU.   "
148724|NCT01337453|"     Botulinum toxin (BoNT) has become a revolutionary treatment for many neurological, autonomic,     gastrointestinal, genitourinary, and cosmetic disorders. The use of this treatment requires     expertise in dosage calculations and application technique to avoid potential side effects.     Most adverse events (AEs) related to BoNT are local and related to its mechanism of action,     i.e., paralysis of unwanted muscles. However, systemic AEs may also be observed. Flu-like     symptoms (FLS) are well recognized AEs in patients treated with BoNT; however there is a     paucity of information regarding the frequency, clinical impact, and associated risk factors     of this particular complication.      Between December 1989 and May 2003, 1,437 reports of BoNT-related AEs were registered at the     Food and Drug Administration (FDA). FLS were reported in 4.6% of serious, and 3.2% of     non-serious side effects.      In this study, the investigators aim to assess prospectively the frequency, clinical     characteristics, and risk factors for development of FLS in a group of patients affected with     diverse movement disorders and treated with BoNT type A at the Parkinson's Disease Center and     Movement Disorders Clinic (PDCMDC) of Baylor College of Medicine (BCM). The investigators     will also assess biomarker of inflammatory response in those patients who develop FLS after     treatment with BoNT.   "
148725|NCT01337440|"     1. Objectives        1. To test whether Ursodeoxycholic Acid (UDCA) increases Glucagon-like peptide-1 (GLP-1)          response to nutrients and improves glycemic control in people with type 2 diabetes.        2. To test whether sitagliptin enhances UDCA-induced beneficial effect in GLP-1 levels and          glycemic control.        3. To test safety of combination therapy of sitagliptin and UDCA in people with type 2          diabetes.      2. Clinical hypothesis.        1. UDCA increases GLP-1 response to nutrients via provoking bile acids excretion from the          liver to the intestine/colon.        2. UDCA improves glycemic control in people with type 2 diabetes.        3. Sitagliptin enhances UDCA-induced response of GLP-1 to nutrients.        4. Sitagliptin has additive beneficial effects with UDCA in glycemic control in people with          type 2 diabetes.        5. Combination therapy of sitagliptin and UDCA is safe and well-tolerated in people with          type 2 diabetes.        6. The combination therapy may loose weight by unique mechanisms of each agent; GLP-1          inhibits appetite by acting on CNS and gastrointestinal motility, whereas UDCA-enhanced          circulating primary bile acids increases energy expenditure through the pathway          involving G protein-coupled bile acid receptor 1 (Gpbar1, or M-Bar, TGR-5) and          subsequent activation of type 2 iodothyronine deiodinase (D2) in brown adipose and          muscle tissues, as reported previously.   "
148726|NCT01337427|"     This research sub-study is being completed as a part of the Multicenter, Randomized,     Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of     PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis     (Protocol #: NA_00028117). This substudy is being done to understand the efficacy of BIIB017     by measuring the nerve fiber thickness in the eye.   "
148770|NCT01336829|"     The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is     absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed     into the body when administered together.   "
148771|NCT01336816|"     This is a study to determine the safety and effectiveness of silver salt in Ariva® Silver     Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the     smoker when tobacco is smoked.   "
148727|NCT01337414|"     Exudative age-related macular degeneration (wet AMD) continues to be a leading cause of     central vision loss in the US for those over fifty years of age, despite the availability of     several effective interventions to contain damaging neovascularization (new, abnormal blood     vessel growth). The effectiveness of treatments is challenged by patients' lack of ability to     recognize the need for urgent care between regular office visits. The Amsler and Yanuzzi     tests, the only widely used self-tests for AMD, have proven largely ineffective at enabling     patients to recognize the signs that they should consult their retina specialist for     treatment.      For optimal benefit, patients should be able to self-monitor their vision over time and     detect changes that may be indicative of an exudative event. To facilitate compliance these     observations should be part of a larger and more engaging program of AMD awareness and     self-monitoring. Among the principal shortcomings of the current gold-standard Amsler grid     are periodicity of the test pattern and lack of individual adjustment, and therefore the     reliability and accuracy of this test are less than optimal for the detection of exudative     retinal changes in AMD patients. In phase I of the current study, the investigatorsW     developed and evaluated several versions of improved grids, both on paper and on the     Internet. These patent-pending Visual and Memory Stimulating (VMS) grids proved at least     equivalent to the Amsler grid in facilitating a substantial degree of recall of prior     measurements, necessary for monitoring vision over time. Adjustment features were     incorporated in the on-line version to allow patients to customize their grid to their     particular visual field. In the phase II study the use of VMS grids will be supplemented by a     test booklet that contains educational materials and diary based survey questions in addition     to the printed VMS grids; the effectiveness of this booklet for self-monitoring will be     compared the standard of care (Amsler grid).      Goal of the study is to demonstrate that use of the test booklet leads to more rapid     identification of newly developing vision problems, earlier diagnosis and treatment of     incipient wet AMD that should result in fewer people losing their vision and less severe     losses of vision.   "
148728|NCT01337401|"     The study is a two-arm, randomised, double-blind, international, multi-centre phase II trial     of cediranib in Alveolar Soft Part Sarcoma (ASPS).      The study aims to confirm the ability of cediranib to halt disease progression in patients     with metastatic ASPS, as measured by the change in tumour size at 24 weeks after     randomisation, and to produce objective response according to RECIST criteria.   "
148729|NCT01337388|"     This observational study will assess the efficacy and safety of RoActemra/Actemra     (Tocilizumab) in smoking versus non-smoking patients with rheumatoid arthritis. Data from     patients treated in routine clinical practice with intravenous RoActemra/Actemra will be     collected for 12 months each.   "
148730|NCT01337375|"     In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon     alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with     viral load and viral kinetics will be investigated in patients with chronic hepatitis C     genotype 1 who were non-responders to previous standard combination therapy with pegylated     interferon and ribavirin. Patients will be randomized to receive either weekly or twice     weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after     a washout period of 6 weeks.   "
148731|NCT01337362|"     Patients with type 1 diabetes are at risk of very low blood sugar levels (hypoglycaemia) as a     severe side effect to insulin therapy, in particular subjects who have lost warning of     hypoglycaemia. During hypoglycaemia a low frequent activity can be seen with     electroencephalography (EEG) as cognitive function declines.      The purpose of the study is to investigate the activity in the brain, the cognitive function,     and the skin temperature when patients are exposed to repeated hypoglycaemia. The results     will show whether the response to hypoglycaemia will change after repeated episodes.      It is our hope that results can contribute to improved understanding of hypoglycaemic EEG     changes.   "
148732|NCT01337349|"     This is a prospective, double blinded randomized clinical study to evaluate the Effects of     Pentoxifylline on left ventricular systolic function indices and circulating biomarkers in     patients with chronic congestive heart failure.      A few studies all focused in Africa have consistently shown marked beneficial effects of     pentoxifylline in improvement of left ventricular size and systolic function along with     marked decrease in biomarkers of heart failure and apoptosis markers on top of standard CHF     therapy. Furthermore pentoxifylline was shown to have negligible effects on heart rate, blood     pressure in those studies. Limitations of these studies are that they are largely single     center originating in the African subcontinent and have never been tested in the North     American population, particularly Caucasians.      Despite major advances in medical therapy for congestive heart failure, it is still one of     the leading causes of morbidity and mortality in North America. Most medications tested for     improvement of Ejection Fraction with the exception of Beta-Blockers and Ace-Inhibitors have     been associated with worsening mortality. Pentoxifylline is a medication that has negligible     effects on myocardial oxygen consumption, yet promising effects on inflammatory markers seen     in CHF with the possibility of improvement in LV systolic function and symptomology and may     prove to be a useful addition for CHF patients. This would prove to be especially useful,     particularly when associated with no major side effects.   "
148733|NCT01337336|"     The objective of this study was to examine COPD-related outcomes for patients with comorbid     depression/anxiety who are on combination fluticasone propionate/salmeterol xinafoate     compared to those receiving anticholinergics.      The prevalence of comorbid depression/anxiety in patients with chronic obstructive pulmonary     disease (COPD) is estimated to be high and range from 10-40%, given that the risk of     depression/anxiety symptoms is almost 3 times higher in patients with versus without COPD.     Additionally, patients with comorbid COPD and depression/anxiety have higher COPD-related     healthcare utilization and costs compared to those without depression/anxiety. Therapy with     maintenance medications for COPD has been recommended to prevent future adverse COPD     outcomes, but the impact of initiating these interventions has not yet been evaluated in a     higher-risk population with comorbid COPD-depression/anxiety. The present study compares the     risk of COPD exacerbations and COPD-related costs in patients initiating maintenance     medications for treatment of COPD in a comorbid COPD/depression-anxiety population.     Maintenance medications include inhaled corticosteroid (ICS), long-acting beta agonist     (LABA), combination drug product of ICS+LABA, and anti-cholinergics (AC) including tiotropium     (TIO) and ipratropium or combination ipratropium-albuterol (collectively abbreviated as IPR).   "
148772|NCT01336803|"     This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with     ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors     to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help     in diagnosing patients correctly and may result in more timely treatment.   "
148773|NCT01336790|"     The purpose of the National Lymphatic Disease and Lymphedema Registry is to collect health     information in order to study the disease classification, natural history, and impact of     Lymphatic Disease, Lymphedema and Related Disorders and its treatments and medical outcomes.   "
186700|NCT00281320|"     This study evaluates the safety and tolerability of Asenapine in elderly patients with     psychosis.   "
148738|NCT01337258|"     The objective of this project is to conduct a retrospective economic analysis of the use of     dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical     trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical     trial of the use of dutasteride compared with no chemopreventive treatment.      The REDUCE trial was a four-year, international, multicenter, randomized, double-blind,     placebo-controlled, parallel group study. There were 790 investigators in 42 countries.   "
148739|NCT01337245|"     The purpose of this study is to see whether a new F(ab')2 antivenom will prevent injury and     death from the bite of a coral snake.      Funding Source - FDA OOPD.   "
148740|NCT01337232|"     This study is designed to examine how much therapy is needed in order to make significant     gains in knowledge and use of complex sentences. Students will be randomly placed in     individual treatment sessions that take place either once or twice per week for nine weeks.     All will receive the same type of treatment, which consists of a focused series of oral and     written language activities. While it is anticipated that students in both groups will     benefit from treatment, we hypothesize that the twice-weekly session frequency will have a     significantly greater impact on level of performance and maintenance of skills after     treatment.   "
148741|NCT01337219|"     Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis     Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the     respiratory affection which appears early in neonates.      The constant improvement in symptomatic treatments and care strategies allowed CF patients'     life expectancy to be increased over the last decades.      Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years     old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.      Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is     obtained by inhaled administration of tobramycin and is active against in-vitro resistant     Pseudomonas aeruginosa.      Study hypotheses :      Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml     administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of     antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus®     in children and adult patients with CF.      Primary objective :      To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by     Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®   "
148742|NCT01337206|"     The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign     esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to     standard therapy, (2) achalasia refractory to standard therapy.   "
148743|NCT01337193|"     The overall purpose of this research is to determine the effect of ultrasound imaging     biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women     with stress urinary incontinence. This study will include women 20 years or older with stress     urinary incontinence.      The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using     transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone     (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group     A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback.     Group B will perform the same 3 pelvic floor exercises without biofeedback.      All participants involved in the study will complete a general medical information     questionnaire. In addition, all participants will have their PFM contraction assessed using     an ultrasound machine placed over the lower abdomen, quality of life assessed with a written     questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at     completion of the study.   "
148744|NCT01337180|"     Exposure to noxious gases and particles is associated with an increased prevalence of     respiratory and cardiovascular diseases. Thus, investigation of possible airway inflammation     and/or systemic inflammation in workers exposed to high levels of dust is important. Silicon     Carbide (SiC) Processing Inc. provides cutting fluid (slurry) for the production of solar     cells and is at present the largest provider of slurry to the solar industry worldwide. In     the production process, the recyclable materials (SiC), polyethylene glycol (PEG)) of the     used slurry are recovered. The airborne exposure consists mainly of SiC (dust particles) and     evaporation from the recycling of PEG. High levels of dust have been measured and, seventeen     per cent of the measurements in the processing hall were equal to or higher than the     Norwegian occupational exposure limit. Thus, assessment of possible systemic and airway     effects of this exposure is of interest. A prospective design will be applied and the effects     studied by means of registration of respiratory symptoms, spirometry, nitric oxide (NO) in     exhaled air, induced sputum and blood sampling over a 3 year period. Exposed subjects will     also be compare with non- or low exposed subjects (administrative/office workers). Efforts     will be made to include all eligible subjects and to avoid drop-outs. If early signs of     airway or systemic inflammation in workers or in cells are demonstrated in the study, it will     be necessary to implement measures to reduce the exposure levels.      The primary aim of the present study of workers exposed to Silicon Carbide dust in the     workplace is to determine whether this exposure is associated with inflammatory changes in     the lungs.      The secondary aims are: - to examine possible changes in systemic inflammatory markers and -     to examine changes in lung function among Silicon Carbide processing workers during a period     of 3 years. Possible changes in lung function will be monitored by spirometry and gas     diffusion measurements (study A). Airway inflammatory responses and changes in circulating     inflammatory markers will be assessed by examination of the induced sputum samples and blood     samples every 6th month in a subgroup of workers (study B).   "
148745|NCT01337167|"     This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when     administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of     DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether     subjects who receive V419 have a similar immune response to the vaccine compared to subjects     who receive licensed component vaccine controls.   "
148746|NCT01337154|"     The goal of this study is to determine the progression-free survival and objective response     rate in subjects with either stage IIIB with pleural effusion NSCLC or stage IV NSCLC who are     treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or     placebo. Subjects will be randomly assigned to receive tamibarotene, 6 mg/m2, divided as     twice daily orally, or an equal number of matching placebo tablets, starting 1 week before     chemotherapy and continuing through all 6 cycles and beyond. Subjects will be assessed for     response on Day 50, Day 113, then every other month using the Response Evaluation Criteria in     Solid Tumors (RECIST 1.1).   "
148793|NCT01336530|"     This is a randomised, double-blind, placebo-controlled, therapeutic confirmatory multicentre     trial with 4 parallel treatment groups. The design is adaptive group-sequential with two     interim analyses, possible sample size re-estimation after the first or second interim     analysis and drop-the-loser approach. The study design was primarily chosen to show superior     efficacy of Tepilta® compared to the single components and to placebo. Evaluation of safety     is a secondary objective.   "
148747|NCT01337141|"     A greater visit frequency between the diabetes mellitus 1 (DM1) patient and the medical team     increases the possibilities to improve metabolic control. The support of telematic visits can     support the patient and the health system.      Patients and Method: 160 patients (from 5 participating centres) with type 1 diabetes     mellitus (DM1) candidates for improved metabolic control selected according to inclusion and     exclusion criteria. The telecare system used is comprised of the patient Unit and the doctor     Unit. The system allows the patient to send glucose values, insulin doses, carbohydrate     contribution and other events via the internet. Both the patient and the professional can use     this information via the telecare system platform.      Work hypothesis      The application of interactive telematic systems between patient-health team will improve the     cost effectiveness of care programmes for optimisation of metabolic control directed towards     diabetes mellitus (DM1) patients.      Objectives:      General Objective Evaluate the impact of the telecare system on the efficiency of economic     and clinical management of human and material resources directed to a program of metabolic     control optimisation in diabetes mellitus 1 (DM1) patients as well as the level of metabolic     control and the quality of life of the patients.      Specific objectives        1. To identify and analyse the influence of the telecare system on patient costs in time,          money and normal work or school activity which the patient has to stop to carry out the          physical visits for following the programme.        2. To identify and analyse the influence of the telecare system on medical team costs in          time, money and care organisation directed towards the monitoring phase of the metabolic          control care programme.        3. To identify and analyse the influence of the telecare system on the level of metabolic          control: Glycosylated haemoglobin and the presence of acute hypoglycemic and          hyperglycaemic complications in diabetes mellitus 1 (DM1) patients that follow the          metabolic optimisation programme.        4. To identify and analyse the influence of the telecare system on the quality of life of          the patient measured in satisfaction scale, impact, social/work concern and concern          relating to diabetes.        5. To identify and analyse the influence of the telecare system on the adherence to          different treatment components.   "
148748|NCT01337128|"     In this prospective study, patients with carotid stenosis will be randomly assigned to one of     the two surgical procedures (carotid endarterectomy (CEA) and carotid stenting (CAS)). Pre-     and postoperative neuropsychological functions, levels of several biomarkers and     intraoperative embolization load will be examined. In a subgroup of patients, MRI-data will     also be gathered. The mix of these data will allow us to answer several questions regarding     the absence or presence of preoperative impairments, postoperative changes in cognitive     performance and possible differences between CEA and CAS regarding postoperative     neuropsychological functions. The use of a matched control group and implementation of a long     term follow-up will contribute to the uniqueness of this study. It will meet several flaws of     previous studies and will complete the ongoing randomized studies comparing CEA and CAS that     are lacking neuropsychological data.   "
148749|NCT01337115|"     The purpose of this study is to determine if the addition of a sciatic nerve block (SNB) to a     continuous femoral nerve block (CFNB) improves post-operative analgesia after knee     arthroplasty.   "
148750|NCT01337102|"     In the treatment of advanced cancer, maximizing quality of life (QoL) is a fundamental goal     for oncologists and their patients. In order to achieve this goal, some form of systematic     and reliable QoL assessment is needed in routine clinical practice to evaluate the impact of     advanced cancer treatments on QoL. The Lung Cancer Symptom Scale (LCSS) is a validated     site-specific QoL measure designed for use in patients with lung cancer undergoing treatment.     Recently it has been developed into an electronic form that uses a hand-held pocket personal     computer (pc) to enhance collection and presentation of QoL assessments into clinical trials     and patient care. This study will evaluate the impact of this computer-generated QoL     (LCSS-QL) assessment on treatment practices for advanced lung cancer patients using a     randomized trial design. The investigators hypothesize that a Computer-Generated Quality of     Life Assessment Program will positively impact treatment patterns for patients with lung     cancer.      Specifically, the investigators hypothesize:        1. Use of the LCSS-QL will increase and accelerate referral to and use of palliative care          services;        2. Use of the LCSS-QL will decrease the duration of palliative chemotherapy treatment with          earlier identification of lack of benefit in some patients;        3. Use of the LCSS-QL may decrease the use of imaging tests to assess objective tumor          response as an indicator of treatment benefit.      Maximizing quality of life is one of the most important goals of palliative chemotherapy in     the treatment of advanced lung cancer. If this simple practical tool can be demonstrated to     improve palliative management of these patients, including optimizing duration of     chemotherapy and use of palliative and supportive services based on patient QoL response,     this will dramatically improve the quality of care provided to advanced lung cancer patients.     This study will also provide a springboard for other ways to incorporate computer-generated     QoL measurement in treatment decision-making in advanced cancer patients, including in other     tumor types such as advanced breast and colorectal cancer.   "
148751|NCT01337089|"     This is a six-month extension study to evaluate the safety of long-term Sativex® therapy when     used as an adjunctive measure in patients with advanced cancer. The study provides continued     availability of Sativex® to patients who completed the preceding Phase 3 study.   "
148752|NCT01337076|"     The Sponsor values the progression of hearing healthcare practice and acknowledges a need for     re-evaluation of indications for determining adult cochlear implant candidacy. This need     arises from current research, peer reviewed literature, and technological advancement with     concomitant performance outcomes. To address this specifically, the Sponsor proposes to     evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised     indication.   "
149290|NCT01329978|"     The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir     (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin     (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.   "
148758|NCT01336998|"     Calprotectin is a cytosolic component of neutrophils .Fecal calprotectin(FC) is a useful     marker for exacerbation of inflammatory bowel disease in children .FC may be a useful marker     for necrotizing enterocolitis (NEC).      NEC is one of the most common ,deadliest and enigmatic intestinal problems encountered mostly     in premature infants. The precise pathophysiology of NEC is unclear ,but major factors     thought to play an important role include an immature intestine ,an inflammatory response to     intestinal microbes,enteral feedings and intestinal ischemia-reperfusion injury.Diagnosis of     NEC is not easy clinically and up to now there is not a simple laboratory test to     differentiate NEC at an early stage from other conditions in the neonate.      Arginine is the substrate for NO production in the gut and its deficiency may cause     vasoconstriction and gut injury and thus predispose to NEC. In previous studies arginine     supplementation was found to reduce the incidence of NEC in premature infants but more     studies are needed for the use of arginine supplementation for the prevention of NEC.      The investigators aim is to measure the fecal calprotectin in very low birth weight (VLBW)     infants during the first month of life as an inflammatory marker of the bowel and evaluate     whether premature infants receiving arginine supplements had lower calprotectin values     compared to the premature infants that did not .      The investigators hypothesize that arginine supplementation in preterm infants reduces the     inflammation of the gut which will be shown by the lower fecal calprotectin values of the     premature infants receiving arginine supplementation.   "
148776|NCT01336751|"     Study Primary Objectives:      To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine     and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in     subjects who failed oral combination therapy with sulfonylurea and metformin.      Study Secondary Objectives :      To compare the following measures between subjects receiving insulin glargine or 75% insulin     lispro protamine suspension/25% insulin lispro:        -  Incidence of hypoglycemia        -  Change in weight        -  Change in serum lipid profile        -  Percentage of subjects achieving A1C levels ≤7%   "
148759|NCT01336985|"     Background:        -  Cancers in other parts of the body often spread to the liver, developing tumors which in          many instances cannot be removed with surgery. Liver chemoembolization is a treatment          that is routinely performed to control liver tumors in those who cannot have surgery. It          has been shown to prolong survival, but does not cure the cancer. During          chemoembolization very tiny beads (drug-eluting beads, or DEB) containing chemotherapy          drugs (usually doxorubicin) are administered directly into the blood vessels of a liver          tumor. The drug within the beads is then released into the tumor whilethe beads          temporarily interrupt the tumor s blood supply.        -  Irinotecan, a drug commonly given intravenously to treat colon cancer, has been given in          chemoembolization procedures in four other studies that have shown that the treatment is          generally well tolerated. Researchers are interested in determining whether giving the          drug irinotecan directly into the liver using drug-eluting beads is not only well          tolerated but also provides a larger dose directly to the tumor as determined by tumor          and normal liver tissue biopsies. The liver biopsies are an optional portion of the          study.      Objectives:      - To evaluate the safety and effectiveness of chemoembolization with irinotecan for tumors     caused by cancer that has spread to the liver.      Eligibility:      - Individuals at least 18 years of age who have melanoma, colon, or another intra-abdominal     cancer that has spread to the liver.      Design:        -  Participants will be screened with a physical examination, medical history, blood tests,          tumor imaging studies, and liver biopsies.        -  Participants will receive up to 3 DEB chemoembolization treatments about 6 weeks apart.        -  After two treatments, participants will have imaging studies to see if the tumors have          shrunk, and those whose tumors have shrunk may have a third treatment.        -  Multiple liver biopsies may be performed and blood samples will be taken to determine          how much drug is in the tumor and the circulation, and to see how the tumor reacts to          the drug.        -  Participants will return for followup visits for up to 1 year.   "
148760|NCT01336972|"     The purpose of the trial was to determine the short-term effects of tolvaptan in patients     with autosomal dominant polycystic kidney disease (ADPKD) at various levels of renal     function.   "
148761|NCT01336959|"     This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients     undergoing cardiac surgery with cardiopulmonary bypass.   "
148762|NCT01336946|"     Overweight and obesity have become a serious global public health problem and the prevalence     of these conditions is even higher among persons with mental disorders, compared with the     general population. Overweight and obesity are partially associated with sedentary lifestyles     and unhealthy eating habits.      The aim of the study is to examine the effectiveness and cost-effectiveness of a health     promotion intervention targeting physical activity and eating habits in persons with mental     disorders.      The study hypothesis is that between baseline and the end of the intervention, and after a     6-month follow up period, significant differences in the primary and secondary outcomes     between the intervention and control group will be identified. The investigators also     hypothesize that the health promotion intervention will be cost-effective.   "
148763|NCT01336933|"     This phase II trial studies how well combination chemotherapy and pralatrexate works in     treating patients with non-Hodgkin lymphoma (NHL). Drugs used in chemotherapy work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing   "
148764|NCT01336920|"     This phase I trial studies the side effects and best dose of carfilzomib in treating patients     with relapsed or refractory T-cell lymphoma. Carfilzomib may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth.   "
148765|NCT01336907|"     The FORESEE HOME is intended for the early detection of central and paracentral     irregularities (abnormalities) in the visual field, most commonly associated with Age Related     Macular Degeneration (AMD). However, the device has the ability to detect the development of     the lesion post treatment and therefore to assess in determination of the next treatment.      The Optical Coherence Tomography (OCT) may be used as well to identify choroidal     neovascularization (CNV). Comparison between the two methods will allow better understanding     of both devices.      The FORESEE HOME can be used as an assessment tool for the progression and success of the     treatment given to AMD lesions. Therefore, evaluating the size and the location of the     treated lesions may serve as an additional tool.   "
148766|NCT01336894|"     RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment     for non-small cell lung cancer. Internal radiation uses radioactive material placed directly     into or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able to     send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known     whether stereotactic body radiation therapy is more effective than surgery with or without     internal radiation therapy in treating non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying how well surgery with or without     internal radiation therapy works compared with stereotactic body radiation therapy in     treating patients with high-risk stage IA or stage IB non-small cell lung cancer.   "
148767|NCT01336881|"     This research trial is studying biomarkers in tissue samples from young patients with liver     cancer. Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.   "
148768|NCT01336855|"     This study seeks to confidentially collect blood from HIV-positive individuals and     HIV-negative controls to provide basic scientists with specimens for collaborative studies.   "
148769|NCT01336842|"     The purpose of this study is to find out if panobinostat taken with cisplatin and pemetrexed     can be used safely without increasing side effects and that the combination will have a     better effect than platinum-based doublet chemotherapy alone.   "
148774|NCT01336777|"     The biological basis for insulin resistance associated with obesity is unknown. By studying     equally-overweight/obese individuals who are either insulin resistant or insulin sensitive,     the investigators will compare characteristics of fat tissue to test several hypotheses: 1)     impaired differentiation and fat storage in the subcutaneous fat depot characterize insulin     resistant individuals, who have, as a result, fat in other tissues like liver and muscle, as     well as more fat circulating in the blood; 2) inflammation is greater in visceral and/or     subcutaneous adipose tissue depots in insulin resistant individuals as compared with insulin     sensitive individuals.   "
148775|NCT01336764|"     Many U.S. military personnel are returning from Operation Enduring Freedom/Operation Iraqi     Freedom (OEF/OIF) deployments with histories of trauma while driving in military vehicles.     The proposed project aims to develop and test a rehabilitative technology aimed at enhancing     emotion regulation and reducing operator-related risk during civilian driving.   "
148777|NCT01336738|"     B2611002 is designed to study how safe and effective an investigational medication     (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5     treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug,     and another treatment will be placebo, which does not contain active ingredient.   "
148779|NCT01336712|"     In this study, patients will receive a myeloablative preparative regimen consisting of     fludarabine and total body irradiation (TBI), followed by a T cell replete, mobilized     peripheral blood stem cell (PBSC) allograft from a partially matched related donor. All     patients will receive post-transplant Cy in addition to standard post transplant     immunosuppression with tacrolimus and MMF. The treatment protocol will be essentially     identical to the prior study, with the exception of the substitution of TBI for Busulfan. The     investigators hypothesize that this change will significantly reduce the risk of HC, while     maintaining the efficacy of the transplant.   "
148780|NCT01336699|"     Phase 1, randomized, double-blind, placebo controlled, dose-escalation, inpatient study of     single doses of S. sonnei. Health adult subjects, ranging in age from 18 to 45 years of age     (inclusive) will be screened. Enroll serial groups up to 90 subjects. The primary objective     is to evaluate safety and tolerance of WRSs2 by monitoring presence, frequency and severity     of clinical signs and symptoms. A secondary objective is to evaluate the immune response in     blood and stool following ingestion of WRSs2 and WRSs3.   "
148781|NCT01336686|"     The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to     placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in     patients with gout.   "
148782|NCT01336673|"     This is a non-interventional, prospective study where no visits or additional interventions     to the daily practice of the physician will be performed. Glucophage XR® has recently been     available in Thailand for the treatment of patients with type 2 diabetes. A prospective     observational study will be valuable to provide information on the day-to-day experience of     using Glucophage XR® in the management of this patient population. The data may provide an     insight into the use of Glucophage XR® in routine clinical practice in Thailand.   "
148783|NCT01336660|"     This study has the objective to demonstrate the effectiveness of Alacramyn NAMO in the     treatment of North Africa and Middle East scorpions envenomation by reducing the severity of     envenomation. The primary endpoint is make a comparison between antivenom and placebo groups,     at 4 hours after study drug, of the number of cases showing improvement in class of     envenomation.   "
148784|NCT01336647|"     Phase 2 study to assess the safety and effectiveness of a product to treat children and     adults with head lice   "
148785|NCT01336634|"     Dabrafenib is a potent and selective inhibitor of BRAF kinase activity. This is a Phase II,     non-randomized, open-label study to assess the efficacy, safety, and tolerability of     dabrafenib administered as a single agent and in combination with trametinib in stage IV     disease to subjects with BRAF mutant advanced non-small cell lung cancer. Subjects will     receive dabrafenib 150 mg twice daily (BID) in monotherapy treatment and dabrafenib 150 mg     bid and trametinib 2 mg once daily in combination therapy and continue on treatment until     disease progression, death, or unacceptable adverse event.   "
148786|NCT01336621|"     The purpose of this Phase III study is to assess the long-term safety, tolerability and     efficacy of flexibly dosed retigabine Immediate Release (IR) as adjunctive therapy in adult     subjects with partial-onset seizures. In addition, those subjects who successfully completed     20 weeks of adjunctive treatment with retigabine IR in the parent study, RGB113905, and who     were thought to have benefitted from treatment will be provided continued access to     retigabine IR.   "
148787|NCT01336608|"     The purpose of the study is to investigate the effect of fluticasone furoate/vilanterol     Inhalation Powder on arterial stiffness compared with placebo and vilanterol over a 24-week     treatment period in subjects with COPD and aortic pulse wave velocity of 11.0 m/s or above.   "
148788|NCT01336595|"     The purpose of this study is to determine if there are any clinical or radiographic     differences in cemented total knee arthroplasty with an oxidized zirconium and a     cobalt-chromium femoral knee component.   "
148789|NCT01336582|"     Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel     formulations in terms of AUC and Cmax.   "
148790|NCT01336569|"     The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering     efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with     open-angle glaucoma or ocular hypertension.   "
152490|NCT01287806|"     The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation     lung injury patients.   "
148791|NCT01336556|"     Background: The oral appliances have been increasingly used in the treatment of primary     snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment     options in adults with moderate to severe sleep apnea who did not accept or adapt to     continuous positive airway pressure (CPAP). It is not well established yet in the literature,     which patients with mild to moderate OSA will present a good response to treatment with oral     appliances.      Objective: To determine a value of CPAP pressure that correlates with a favorable response to     the use of oral appliance in patients with mild to moderate sleep apnea.      Patients and Methods: Two groups of 30 male patients (25-65 years, body mass index < 35     kg/m2) will be selected: the first group with an apnea-hypopnea index (AHI) between 5 and 15     events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of     sleep. Each patient will undergo three polysomnographic recordings (baseline, CPAP titration,     after two months of treatment with oral appliance). Subjective (sleep disorders     questionnaire, the Epworth Sleepiness Scale, and sleep diaries) and objective     (polysomnography) parameters of sleep will be evaluated, besides the quality of life (SF-36),     mood (POMS), and anthropometric measurements (neck circumference and craniofacial     characteristic). Good response to treatment with the AIO will be considered as a 50%     reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of     sleep.   "
148792|NCT01336543|"     This is a pilot phase II study of histology based consolidation chemotherapy in patients with     inoperable stage III Non-Small Cell Lung Cancer (NSCLC) following concurrent     chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard     concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be     offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of     consolidation with gemcitabine.   "
148794|NCT01336517|"     The main purpose of this investigation is to evaluate the effect of a lower leg brace on     walking efficiency and community walking in people who have weakness in one side of the body     caused after a stroke. The evaluation will consist of several tests that will evaluate     movement, tightness, balance and sensation in affected leg.   "
148797|NCT01336452|"     Hepatocellular carcinoma is the sixth most common malignancy and the third most common cause     of cancer-related death worldwide. The incidence of HCC is rising in Europe and the United     States and is expected to continue to increase during the next 2 to 3 decades. The expected     survival rate is still decimal, especially in patients with advanced HCC. However, in recent     years, several treatment methods for patients with advanced HCC, including antiangiogenic     chemotherapy, radiotherapy, concurrent chemoradiotherapy, and DC bead transarterial     chemoembolization, have been developed. Among these new treatment methods, concurrent     chemoradiotherapy has also proved to increase patient's survival rate. It is important to     predict treatment response before treatment or immediately after treatment because there are     several other treatment options as mentioned above. Recently, there have been several reports     that MR perfusion parameters such as Ktrans can predict treatment response in cervical cancer     and colorectal cancer. Therefore the purpose of the investigators study is to evaluate the     feasibility of predicting treatment response by MR perfusion, contrast enhanced ultrasound     parameters and biomarkers (IL-6, IL-12 and VEGF) in patients with advanced hepatocellular     carcinoma who undertake concurrent chemoradiotherapy.   "
148798|NCT01336439|"     The purpose of this study is to evaluate the effect of Botulinum toxin type A(Meditoxin®) on     bruxism using polysomnography and determine which site is most appropriate for injection to     obtain maximal effects.   "
148799|NCT01336426|"     Purpose      This study is to verify and validate PAD1 as a qualitative serum test which will combine the     results of multiple assays into a single numeric result, to be determined by evaluation of     the study data.      PAD1 is an automated software device (PADCalc) that incorporates specific and multiple     biomarker values found in human blood, and generates a score (PAD1 score) using a fixed     formula implemented within the PADCalc software. The PAD1 score is a result with a high or     low probability of PAD.      PAD1 will be submitted to FDA as a 510(k) for in vitro diagnostic use in conjunction with     clinical assessment, based on factors such as age, diabetes, smoking, and vascular laboratory     tests (including the ABI), as an aid towards further evaluation of patients who meet the     enrollment eligilbility criteria.      Eligibility It is indicated for women and men considered at risk for PAD who meet the     following criteria: a history of smoking and/or diabetes and are age 50 years or older, or 70     years of age or older. PAD1 is an aid to further assess the likelihood of the presence of PAD     when used in conjunction with clinical assessment and vascular laboratory tests.   "
148825|NCT01336088|"     The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in     Parkinson's disease patients following four weeks of dosing.      The secondary objectives of the study include the evaluation of the efficacy of ADX48621     compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's;     the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient     ability to function, and the evaluation of the effect of coadministration of ADX48621 on     L-dopa efficacy.   "
149085|NCT01332695|"     This study will look at the ability of ST101 to treat symptoms in subjects with Essential     Tremor. This study will also examine the safety and tolerability of the drug. This study is     evaluating one dose level of ST101 versus placebo in a cross-over fashion. This means that     all patients will receive both ST101 and placebo, but they will receive it in a random (by     chance) order.   "
148800|NCT01336413|"     Purpose: Mild traumatic brain injury (TBI) is extremely common among OEF/OIF (Operation     Enduring Freedom/Operation Iraqi Freedom) era Veterans. Mild TBI is frequently accompanied by     post-traumatic stress disorder (PTSD) and depression symptoms, co-occurring disorders that     contribute to increased disability and decreased quality of life. Neuroactive steroids (NS)     represent promising pharmacological candidates for intervention for these diverse symptom     domains, since a number of these molecules demonstrate pronounced neuroprotective and     neurotrophic properties. The NS pregnenolone (PREG) is a logical therapeutic option, since it     enhances learning and memory and also increases myelination in rodent models. Further,     decreases in PREG have been associated with depressive symptoms, and PREG is also metabolized     to allopregnanolone (ALLO), an anxiolytic downstream NS that is decreased in PTSD. ALLO also     enhances neurogenesis in rodents. The investigators thus propose an RCT in OEF/OIF era     Veterans with mild TBI.      Methodology: The design of this study will be randomized, placebo-controlled, double-blind.     Trial duration will be 10 weeks, consisting of a 2-week placebo lead-in period for all     subjects, followed by 8 weeks of treatment with either pregnenolone or placebo. The primary     cognitive outcome measure will be executive functioning (as assessed by the Tower of London     test), and the primary behavioral outcome measure will be PTSD Cluster D symptoms (as     assessed by the Clinician-Administered PTSD Scale, CAPS). The investigators will also     determine if PREG administration in OEF/OIF Veterans with mild TBI increases downstream ALLO     and/or other GABAergic NS levels, and the investigators will identify the specific metabolism     profile of PREG following eight weeks of treatment with this neurosteroid.      Anticipated Findings: The investigators hypothesize that treatment with PREG in OEF/OIF era     Veterans with mild TBI will significantly improve executive functioning compared to the     placebo condition. The investigators also predict that treatment with PREG will decrease     Cluster D PTSD symptoms compared to treatment with placebo.   "
148801|NCT01336400|"     The investigators previously developed approaches to SNP-, CNV- and haplo-type single human     cells (Vanneste et al. 2009, Nature Medicine). These methods open the possibility to be     developed into a novel generic diagnostic technique which broadens the spectrum of     disease-alleles that can be selected against during preimplantation genetic diagnosis (PGD)     and which enables to help those couples that cannot be supported by PGD yet. PGD is the     genetic analysis of a single blastomere from an in vitro fertilized (IVF) embryo and it is     offered to couples to avoid the transmission of heritable genetic disorders to their     offspring. PGD analyses are performed for (1) autosomal dominant or recessive monogenic     diseases, (2) X-linked disorders and (3) chromosomal aberrations that may result in aneuploid     conceptions. This novel method is likely to outperform and hence, replace current techniques     for preimplantation genetic diagnosis. In this project the investigators will bring the     technology from a proof-of-principle to the clinical application. To this end the     investigators will make computational improvements for accurate single blastomere SNP-, CNV-     and haplo-typing and perform a large validation study. For the validation studythe     investigators will analyse the genomes of the blastomeres derived from 60 spare embryos of     different origin: (1) Embryos diagnosed as genetically abnormal using current PCR- and     FISH-protocols. (2) Embryos diagnosed as normal for the investigated region using current     PCR- and FISH-protocols, but not of sufficient quality to be transferred or frozen. (3)     Embryos of the sex that is selected against following PGD based sex-selection, or embryos of     the sex that is selected for but of insufficient quality to be transferred or frozen. (4)     Embryos that were not biopsied in a PGD cycle since they suffer a slight growth delay. This     validation study will allow us to evaluate (1) the clinical validity (false positive and     negative rate) and (2) clinical applicability (in terms of ease of use, success rate, etc.).     In addition, it will bring us essential further fundamental insights in the origins and     mechanisms of chromosomal instability operating during early embryogenesis and its     consequences for clinical applications of PGD. Finally, following the validation study, this     project will clinically implement the technique to treat 10 families.   "
148802|NCT01336387|"     This randomized phase I trial studies the side effects and the best dose of retinoid 9cUAB30     in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from     forming. The use of retinoid 9cUAB30 may keep cancer from forming.   "
148803|NCT01336374|"     The purpose of this study is to determine the impact of vacant lot greening on perceptions of     safety and violence for residents living around the lots. We hypothesize that people living     around lots that are greened will have improved perception of safety.   "
148804|NCT01336361|"     The purpose of this study is to explore emerging physical therapy practice in palliative     care, and the perceptions of physical therapists regarding their care of the functionally     dependent elderly, including: (1) the role and utilization of palliative care intervention in     current practice, (2) current and potential goal-setting practices which may relate to     palliative care, and (3) therapists' awareness of cultural and psychosocial issues in patient     care.   "
148805|NCT01336348|"     This is a single-centre, open-label prospective randomized pharmacodynamic investigation of 2     antiplatelet regimens in patients undergoing coronary intervention for ST segment elevation     myocardial infarction(STEMI):        1. Tirofiban bolus only or bolus followed by 2 hour infusion on top of 600 mg clopidogrel          or 60 mg prasugrel.        2. Prasugrel given at 60 mg.   "
148806|NCT01336335|"     Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular     disease even in the absence of hypertension. However, there are few data regarding the impact     of OSA on the sympathetic system in apparently normotensive patients with OSA as well as the     impact of treatment with continuous positive airway pressure in different sites of activation     (heart, peripheral nerves and circulating catecholamines)   "
148807|NCT01336322|"     The goal of the present research is to compare the effects of treatment with metformin and     sitagliptin, alone or in association, in women with previous gestational diabetes to evaluate     the impact of the two drugs on beta-cell function. The study results may contribute to give a     rational approach for future investigations.   "
148808|NCT01336309|"     This study comprises 4 phases designed to systematically develop and test a reliable, valid     and useful quantitative measure of the components and dimensions of yoga; each phase builds     on the previous phase. Phase I aims to gain a comprehensive understanding of the relevant     aspects of yoga therapy and develop a large pool of potential questionnaire items by     conducting a thorough literature review and focus groups with yoga teachers and students.     These data will be analyzed using rigorous qualitative methods to identify key conceptual     dimensions associated with yoga interventions. Phase II will develop a prototypic     questionnaire to assess yoga therapy by refining and honing information from Phase I and     conducting cognitive interviews to further develop this instrument. Phase III will pilot test     the measure in a field observation of yoga students and use factor analysis and item response     theory to select the best items per dimension and to reduce the number of items in the     measure. Phase IV will collect data on the new instrument and test the psychometric     properties of the questionnaire (i.e., reliability and validity using data collected in     Phases III and IV).   "
148809|NCT01336296|"     This study is specifically designed to determine whether the initiation of Myfortic 2 weeks     prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy     in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to     Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction     starting at the time of transplant in kidney transplant recipients.   "
149086|NCT01332682|"     The purpose of this feasibility study is to examine the safety and effect of resistance     training on muscle strength, lean body mass, physical functioning, fatigue, and quality of     life in head and neck cancer patients receiving radiation therapy.   "
152342|NCT01289743|"     The study has the aim to investigate the efficacy and safety of etanercept in patients with     active ankylosing spondylitis (AS) over 520 weeks.   "
148810|NCT01336283|"     Aims: To prove the benefits of an specific strength training program in COPD patients     compared to those achieved with the traditional endurance training. We will assess which is     the proper training modality and which of them is the most beneficial according to the     features of the patient to whom it is applied.      Subjects and Methods: We will study 66 patients diagnosed of COPD with a moderate-severe     obstruction (FEV1<60%) and clinically symptomatic. The monitoring will be done for 3 moths.     Patients will be differentiated between COPD with predominant chronic bronchitis and COPD     with predominant emphysema, with regard to clinical, functional and radiological criteria.     After stratification of the sample, patients will be prospectively assigned to three groups     of 22 patients each: a) Endurance training group, on cycle ergometer at a workload of 70%     VO2max. b) Strength training group, with 5 different weightlifting exercises (4 sets of 6-8     repetitions). c) Mixed training group, with half the time dedicated to each type of training.     Training will be developed during 12 weeks, three times per week, in 40 minutes sessions.     Analysed variables, at the beginning and at the end of program will be: Chest X-ray, basic     blood analyses, electrocardiogram, simple spirometry and bronchodilator test, blood gases,     static pulmonary volumes, diffusion measurement and respiratory muscle pressure. Muscle     strength will be assessed by means of 1RM test and the Myometer® dynamometer. Using the     muscle skeletal ultrasound, we will control changes in muscle fibre size. Maximal and     submaximal exercise tests on cycle ergometer will be also performed, so as a walking test     (shuttle walking test). At last, we will assess treatment effect on dyspnea (Mahler`s test)     and quality of life (CRDQ).      Hypothesis: A strength training program would significantly increase peripheral muscle power.     This type of training would mainly have effect on the predominant emphysema COPD patient,     where the important weight lost causes a decrease in muscle strength.   "
148811|NCT01336270|"     Melanoma tumor tissue ( in particular regressive areas) present a lymphocytic infiltrate with     an anti-tumoral specificity. The aim of the study is to analyse at different stages of the     disease, tumor samples and to characterise the cellular infiltrate in situ ( in particular T     lymphocytes, NK cells and macrophages), the role of inhibitor receptors on in situ     immunosuppression, and potential modulation by medical treatments such as dacarbazine.   "
148812|NCT01336257|"     Clinical decision support has been shown to improve the performance of screening tests;     however, few studies have documented direct clinical benefit resulting from the increased     screening promoted by clinical decision support systems.      The purpose of this study was to determine if a standards-based, sophisticated decision     support system could not only promote additional breast cancer screening, but also detect     significantly more breast cancer   "
148813|NCT01336244|"     The purpose of the study is to evaluate the safety and tolerability of multiple ascending     oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and     to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple     oral administrations.   "
148814|NCT01336231|"     Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients     treated with anti-angiogenic for metastatic kidney cancer   "
148815|NCT01336218|"     The purpose of this study is to investigate the drug interaction between fostamatinib and     rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib     when administered alone and with rifampicin in healthy subjects   "
148816|NCT01336205|"     The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118     treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.   "
148817|NCT01336192|"     Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death.     Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer     (NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate     measure. The standard treatment for this patient population consists of third generation     platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until     disease progression (PD) before the administration of second-line and third-line systemic     anticancer therapeutic agents. Patients who go on to receive second-line therapy represent a     selected subgroup with an improved overall prognosis.      Switch maintenance therapy with pemetrexed or erlotinib in patients with advanced NSCLC     without PD after first-line chemotherapy has been confirmed to improve progression free     survival (PFS) and overall survival (OS) significantly compared with placebo in two large     randomized controlled studies. However, continuation gemcitabine maintenance therapy in this     setting yields conflicting results in the west, i.e.showing a prolongation of PFS without OS     improvement. Thus, we investigate the efficacy and safety of continuation of gemcitabine     maintenance therapy for patients with metastatic NSCLC with ECOG performance status of 0-1     and without PD after four cycles of first-line chemotherapy with gemcitabine and cisplatin in     China.   "
148818|NCT01336179|"     The purpose of the proposed study is to compare the effect of chewing sticks (Miswak) and the     toothbrushes on plaque removal and gingival health.   "
148819|NCT01336166|"     The aim of this study is to investigate the long-term immunogenicity and safety of the     inactivated split-virion vaccine after one immunization.   "
148820|NCT01336153|"     To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese     Medicine on motor recovery after ischemic stroke.   "
148821|NCT01336140|"     The routine administration of 75 mg of intravenous aminophylline in patients with severe     chronic kidney disease undergoing a nuclear stress test with regadenoson (Lexiscan®) can     reduce or eliminate the incidence of diarrhea and other side effects related to regadenoson.   "
148822|NCT01336127|"     The purpose of this study is to determine the effectiveness of occupational therapy in     Parkinson's disease.   "
148823|NCT01336114|"     Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the     spine. In case of progressive curve deformity, the use of spinal bracing remains the standard     non operative treatment of moderate AIS. Most of the time, the different types of braces     don't take into account the individual biomechanical properties of each patient's spine.     Actually, it is essential to better understand the effect of the loads applied on the trunk     and on the spine, and a 3D geometrical modelisation of these components is essential. Many     studies have been publishing concerning the use of radiographs for the geometrical     reconstruction of the spine, and more recently the EOS system. But even then, it is still     necessary to obtain an important number of geometrical data and discretisation is still a     long procedure.   "
148824|NCT01336101|"     The intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in     patients with superficial femoral/ popliteal artery disease.      100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study and     shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which time     the stent will be placed, and follow-up visits at 6 and 12 months.      Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will     be efficacious in patients with Superficial Femoro/Popliteal Artery disease.   "
148826|NCT01336075|"     The purpose of this study is to compare two invasive treatments of symptomatic paroxysmal     atrial fibrillation: Percutaneous radiofrequency catheter ablation and mini invasive     thoracoscopic radiofrequency ablation in patients referred for a first time invasive     treatment for atrial fibrillation.      The hypothesis is, that mini invasive thoracoscopic radiofrequency ablation as a first time     invasive treatment is more effective compared to a percutaneous catheter based technique in     patients with symptomatic paroxysmal atrial fibrillation refractory or intolerant to at least     one antiarrhythmic drug.   "
148827|NCT01336062|"     Gastric cancer have poor prognosis and majority of patients resistant to 5-FU/DDP based     first-line chemotherapy in China. There was no recommended second-line chemotherapy for     advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound     Paclitaxel (Abraxane，ABI-007) has good convenience to use and been approved in breast cancer     in many countries. The investigator then initiated a prospective phase Ib/IIa clinical trial     with nab-paclitaxel plus TS-1 as the second-line treatment in advanced gastric cancer to     observe the safety and efficacy.   "
148828|NCT01336049|"     Nimotuzumab, as one new agent used in advanced esophageal carcinoma, has been shown to be     effective and safe in some studies with head-neck cancers. Advanced esophageal carcinoma have     poor prognosis and majority of patients resistant to chemotherapy in China. In the     investigators phase II clinical trial proceeded before,the combination of paclitaxel with     cisplatin showed good tolerance and efficacy to esophageal carcinoma. The investigators then     initiated a prospective phase II clinical trial with Nimotuzumabplus paclitaxel/cisplatin as     the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of     the combination.   "
148829|NCT01336036|"     This is a descriptive clinical research aiming:        -  To describe the clinical spectrum and clinical characteristics of community acquired          pneumonia (CAP) in patients admitted to hospital        -  To identify the etiology of CAP and the antibiotic sensitivity of the isolated organisms        -  To identify the risk factors that influence the severity of CAP   "
148830|NCT01336023|"     This trial is conducted globally. The aim of this trial is to compare the efficacy and safety     of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide     (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment     with metformin or metformin + pioglitazone throughout the entire trial.   "
148831|NCT01336010|"     To determine whether response guided treatment with pegylated interferon +/- ribavirin is     effective for the treatment of recently acquired hepatitis C infection. Response guided     treatment is when the length of treatment is determined by how quickly you respond to the     treatment.   "
148854|NCT01335711|"     To explore the effect on early viral kinetics and viral load, and to determine safety,     tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered i.m.     in combination with electroporation followed by standard of care (SOC) in treatment naïve     chronic HCV genotype 1 patients.   "
148832|NCT01335997|"     This study is being done to find out if tablets containing extended release (ER) niacin,     laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin     and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol     and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g /20 mg is     equivalent to ERN/LRPT 2 g coadministered with simvastatin 20 mg in reducing low-density     lipoprotein cholestrol (LDL-C).   "
148833|NCT01335984|"     This is a multi-centered, randomized, parallel group, interventional & open label clinical     trial accessing efficacy of intervention effect by smart care system over existing treatment     group for lowering blood pressure of hypertension patients taking anti-hypertension drug.   "
148834|NCT01335971|"     Evidence from investigators' group has shown that chronic obstructive pulmonary disease     (COPD) patients have impairment of antioxidant defenses which are caused by a defect in     activity of Nrf2. This trial focuses on sulforaphane, a derivative of cruciferous vegetables,     which is a potent stimulator of Nrf2 activity. The investigators want to investigate whether     ingestion of sulforaphane by COPD patients will increase Nrf2 activity and expression of     downstream antioxidants. Accordingly, the investigators are conducting a placebo-controlled     randomized proof of principle trial of two oral doses of sulforaphane, 25 and 150 micromoles,     for 4 weeks in 90 COPD patients. The investigators' goal is to establish a safe and tolerable     dose of sulforaphane that effects in vivo antioxidants via Nrf2, then the investigators will     have a novel candidate treatment for longer-term efficacy trials.   "
148835|NCT01335958|"     This is a Phase I, multi-center, open-label, dose-escalation study of DMUC5754A administered     as a single agent by intravenous (IV) infusion to patients with platinum-resistant ovarian     cancer or unresectable pancreatic cancer.   "
148836|NCT01335945|"     CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of     epigastric/abdominal pain associated with pancreatic cancer.   "
148837|NCT01335932|"     To evaluate whether administration of ganciclovir reduces serum IL-6 levels (i.e. reduction     between baseline and 14 days post-randomization) in immunocompetent adults with severe sepsis     or trauma associated respiratory failure.      Primary Hypotheses:      - In CMV seropositive adults with severe sepsis or trauma , pulmonary and systemic CMV     reactivation amplifies and perpetuates both lung and systemic inflammation mediated through     specific cytokines, and contributes to pulmonary injury and multiorgan system failure,      AND      - Prevention of CMV reactivation with ganciclovir decreases pulmonary and systemic     inflammatory cytokines that are important in the pathogenesis of sepsis and trauma related     complications.   "
148838|NCT01335919|"     The purpose of this study is to evaluate hemoglobin (Hgb) measurement by Masimo-developed     pulse co-oximetry in pediatric patients weighing less than 3 kilograms (Kg).   "
148861|NCT01335620|"     This is a phase I, open label, prospective, one phase pharmacokinetic and observational     study.      Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be     receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence     of previous HIV- resistance mutations on genotypic resistance testing.      At baseline, subjects will switch antiretroviral therapy to:        -  tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus        -  raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24          hour pharmacokinetic visit.      Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits     that will include standard safety parameters. Assessment of cardiac biomarkers at baseline     and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and     on day 180 will also be undertaken.      Following completion of this study, subjects will recommence their usual antiretroviral     treatment regimen and attend for a study follow up visit.   "
148839|NCT01335906|"     Study objectives: to evaluate the effects of information about benefits and risks of     mammography screening on participants in terms of knowledge, attitude, rates of uptake, fear     of cancer, anxiety, and conflict decision. Study hypothesis: information about benefit and     risks of mammography screening increases the women´s knowledge of it; allows women to make an     informed decision on whether to stop or continue the screening program, changing the actual     participation rate; anxiety and fear are not increased. Design: randomized controlled     clinical trial with non-pharmacological intervention. Subjects and setting of study: women     referred to mammography screening in the District Bay of Cádiz-La Janda. Interventions:     random assignment of women in two arms according to the information provided. Control arm is     the standard information; it consists of receiving information normally provided to women     attending the screening program for breast cancer. Intervention arm is the experimental     information and consists of receiving accurate verbal and written information about the     benefits and real risks of mammography screening programs by a physician investigator.     Determinations: knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict     decision.   "
148840|NCT01335893|"     Our specific aim is to determine if Indocyanine Green (ICG) administered intraoperatively and     imaged using our camera will aid in the identification of a suspected lung nodule.   "
148841|NCT01335880|"     This study tests two different incentive mechanisms to induce members of a particular urban     senior center to attend more exercise classes. Coupons for future use are given to     participants who attend an exercise class and will be redeemable within either a one week or     three month time period, depending on which experimental group the participant is assigned     to. Frequency of exercise class attendance at the end of 2 months will be the primary     outcome.   "
148842|NCT01335867|"     The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug and     alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for the     treatment of seizures. It has not been proven to be effective for the treatment of alcohol or     cocaine dependence.   "
148855|NCT01335698|"     The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a     regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse     transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.   "
149186|NCT01331382|"     Resveratrol is associated with a plethora of physiological effects in humans, including     modulation of cerebral blood flow, despite apparently poor bioavailability. This study     investigated whether the physiological effects of resveratrol could be affected when     co-supplemented with piperine, an alkaloid which may be able to enhance the bioavailability     of resveratrol.   "
148843|NCT01335854|"     The proposed research will evaluate new approaches to improving the ability of patients with     obstructive sleep apnea (OSA), a breathing disorder during sleep, to use continuous positive     airway pressure (CPAP), a medical device worn during sleep to treat OSA. 120 patients with     newly diagnosed OSA who are being initiated on CPAP treatment will be assigned to one of 3     groups: usual care, usual care with web-based access to daily CPAP adherence, and usual care     with web-based access to daily CPAP adherence and a financial incentive to use CPAP at least     4 hours/day in the first week of treatment. Measures of CPAP use, daytime sleepiness, and     quality of life will evaluate whether patients provided web-based access to their daily CPAP     adherence with and without financial incentive will have greater objectively measured average     daily hours of CPAP use and greater improvement in functional outcomes following 3 months of     treatment compared to patients receiving usual care.      The results will test the hypothesis that these behavioral interventions will improve patient     adherence to CPAP during the critically important first week of treatment when many patients     are deciding whether or not to use CPAP and that this initial level of adherence will be     maintained over the long term despite withdrawal of the financial incentive.   "
148844|NCT01335841|"     The purpose of this study is to demonstrate an optimization of the establishment of     orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and     navigation system versus conventional method involving anatomical landmarks and 2D     fluoroscopy.   "
148845|NCT01335828|"     Define an ultrasound/elastography benignity criteria in strategy management of a patient     population carries one or more thyroid nodules.   "
148846|NCT01335815|"     Summary: The purpose of the study is to prove if the biomarker high sensitive troponin T     (hsTnT) and the biomarker of endogenous stress copeptin can serve as surrogate parameter of     prognosis in patients with elective knee and hip total endoprosthesis.   "
148847|NCT01335802|"     Studies have demonstrated a relationship between subclinical hypothyroidism and obstetrics     complications like preterm delivery, pre-eclampsia, placental abruption and stillbirth.     Subclinical hypothyroidism and positive thyroperoxidase antibodies (TPOab) may increase the     risk of early spontaneous abortion before 12 weeks of gestation. But there is not a consensus     if the prevalence of TPOab should be treated before and during pregnancy when the level of     thyroid-stimulating hormone (TSH) is normal.      Thyroid hormones are regulators of the mitochondrial activity and our research group has     previously shown that subclinical hypothyroidism affects mitochondrial activity.      The hypothesis:      Subclinical hypothyroidism causes early spontaneous abortion and or complications in     pregnancy like pre-eclampsia because of mitochondrial dysfunction   "
148848|NCT01335789|"     The purpose of this study is to evaluate how people who frequently use marijuana respond to a     stressful task, and if a medication (oxytocin) affects this response.   "
148849|NCT01335776|"     Sleep disturbance in cancer patients is often overlooked despite its documented high     prevalence and negative impact. There are few empirically validated non-pharmacological     treatments for insomnia and many patients are unwilling to rely on sleeping medications. This     study will determine whether Mindfulness-Based Stress Reduction (a program that teaches     meditation and yoga) produces equivalent results with the additional benefits of reduced     stress and mood disturbance, to an already established treatment for insomnia,     Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for     insomnia beyond what is currently available and improve quality of life for millions of     cancer survivors.   "
148862|NCT01335607|"     The purpose of this study is to:        -  Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and          tablet prototype test formulation)        -  Compare the amount of study drug that is in the blood after taking either the capsule          form of the drug or the tablet form of the drug while fasting.        -  Determine the amount of study drug that is in the blood after eating a meal.        -  Evaluate the safety of the tablet form of samatasvir in healthy people.   "
148863|NCT01335594|"     The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is     associated with deviant pharyngeal swallowing function, using clinical, endoscopical and     manometric evaluation.   "
148864|NCT01335581|"     The purpose of this study is to evaluate the RevLite laser in the treatment of refractory     mixed type melasma.   "
148850|NCT01335763|"     Background: Approximately 1.9 million Canadians are living with diabetes and this is     estimated to increase by 75% over the next few decades. Pharmacists are front line primary     healthcare professionals who see patients with diabetes frequently and in Alberta, they have     been allowed to prescribe medications and order laboratory tests. As such, pharmacists could     systematically identify poorly controlled diabetes patients and provide greater access to     diabetes interventions to improve blood sugar control.      Objective: The aim of this study is to determine the effect of a community pharmacist     intervention on blood sugar control in individuals with poorly controlled diabetes.      Project description:      100 adults with type 2 diabetes and uncontrolled blood sugar will be defined by the     participating pharmacists. Blood sugar control is going to assessed using hemoglobin A1c test     (a blood test to measure individual's blood sugar control over the last 3 months). This test     requires obtaining a blood spot from the patient which will be obtained by pricking his/her     fingertip. Based on the hemoglobin A1c test result the pharmacist will assess the patient's     need for insulin glargine, if the patient needs insulin glargine the pharmacist is going to     prescribe it for him/her and educate him/her on its use. Patients are going to be followed up     closely by the pharmacists for 6 months with regular updates to the patients' family     physicians. This multi-centre study should demonstrate pharmacists' ability to improve     glycemic control and improve access to care.   "
148851|NCT01335750|"     This study is a clinical comparison of the biocompatibility of several multipurpose     solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution     among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one     research site.   "
148852|NCT01335737|"     The purpose of this study is to test the hypothesis that aerobic exercise leads to     attenuation of the inflammatory response to lipopolysaccharide (LPS) stimulation.   "
148853|NCT01335724|"     The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel     compared with placebo applied four times a day in subjects with acute neck pain.   "
148856|NCT01335685|"     This will be a phase 1/2, multicenter, 2-arm, open-label study using the oral formulation of     IXAZOMIB when added to standard melphalan and prednisone (MP) treatment. Both phases of the     study will include patients who have newly diagnosed multiple myeloma and are ineligible for     high-dose therapy plus stem cell transplantation because of age (≥65 years of age) or     coexisting conditions and for whom standard MP treatment is indicated.      Note: Phase 2 of the trial will be randomized.   "
148857|NCT01335672|"     An estimated three million people are affected by chronic obstructive pulmonary disease     (COPD) in the UK, giving it a prevalence of 1.5% of the population in 2007/08. COPD accounts     for approximately 30,000 deaths each year in the UK and is an important co-morbidity in those     dying from other smoking related diseases, most commonly ischaemic heart disease and lung     cancer. The National COPD audit showed a very high level of co-morbidity, the association     with cardiovascular disease being particularly strong with 51% of patients with     cardiovascular disease having been admitted for COPD within the preceding 24 months. Patients     with COPD are at increased risk of myocardial infarction compared to the general population.     Although this increase in cardiovascular risk exists, it is not clear is whether survival     after myocardial infarction is different in patients with and without COPD and what factors     contribute to this survival difference. Differences in survival may arise due to differences     in prescribing certain drugs such as beta-blockers, differences in prevalence of risk factors     (e.g. current smoking status) or increased COPD events such as exacerbations which themselves     are associated with increased mortality.      The investigators primary aim is to investigate whether survival after first myocardial     infarction is shorter in patients with COPD than those without COPD and to establish reasons     for these differences in survival.   "
148858|NCT01335659|"     The investigators studied the relations between coronary angiography (CAG), intravascular     ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.   "
148859|NCT01335646|"     The objective of this study is to determine if surgery is superior to non-operative care for     sciatica caused by a lumbar disc herniation. This study will include patients that have had     severe sciatica for greater than 4 months which reflects the wait time of the Canadian health     care system. This study is an opportunity to make an important contribution to medical     science as there is no top tier evidence for or against this highly prevalent surgery.     Although there have been several recent randomized trials in the field, all have been marred     by a large number of patient crossing over from non-operative to operative treatment. Due to     the wait for spine surgery, the Canadian system has a built-in delay that prevents such a     cross over of patients. This study capitalizes on this unique opportunity to perform a high     caliber surgical trial. Patients consenting to be in the study will be randomly assigned to     expedited surgery within three weeks or standardized non-operative care while they wait on     the surgeons list for consultation and then surgery (minimum wait of 9 months). The study     will assess pain, function, quality of life, satisfaction, and work status to determine if     one treatment is superior.   "
148860|NCT01335633|"     The study will entail cognitive assessment of a single cohort of patients with Multiple     Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no     intervention or control group. Each participant will have a caregiver capable of responding     to a brief report of observations regarding neuropsychological skills and abilities in the     patient.   "
148886|NCT01335295|"     Objective of this study is to evaluate safety and tolerability of flavocoxid administered at     the daily oral dose of 500 or 1000 mg/die for one year in DMD patients, alone or in     association with steroids (deflazacort on alternate days) started at least one year before.     The investigators will also perform a multidimensional clinical evaluation covering     functional and muscle strength and quality of life (QoL)assessments.   "
148865|NCT01335568|"     This clinical investigation of the hepatocyte matrix implant is an evaluation blinded     non-randomized and monocentric pilot study of Phase I, which is conducted as a therapeutic     investigation. Randomization is not possible due to ethical and practical reasons. This study     has already been approved in Switzerland and has been adapted to Indonesian Law and disease.      This new treatment procedure has already been successfully used on the basis of compassionate     use in Germany. The hepatocyte matrix implant is a new patented procedure consisting of     bio-matrix technology. A formaldehyde-free special matrix consisting of self-dissolving     polymers is applied as a carrier substance and is cultivated with human autologous cells     using a special technique. Clinically the bio artificial liver replacement tissue for     patients with end-stage hepatic disease has been developed as a first application. In this     procedure autologous hepatocytic tissue and pancreatic tissue is removed (liver resection and     pancreatic biopsy) from the patient in a first surgical procedure. The tissue is sent to a     specialized Cell Culture Laboratory. The laboratory is GMP certified for this procedure. The     cells are processed according to SOPs in a special perfusion procedure and prepared on     several platelets of matrices (platelets of 20 mm diameter and 4mm thickness). After     completion of the laboratory process the bio tissues are implanted into the mesentery of the     small intestine during a second operation. The cells are growing controlled on the matrix,     take on the capillaries of the patient and thus connect to the blood circulation. The     implanted cells multiply by a specific factor and independently take over the metabolic     function of the original liver after two to four weeks. In the following process the carrier     matrix dissolves completely and implanted cells develop into liver cell tissue.   "
148866|NCT01335555|"     It is important to assess patients' fitness for major cancer surgery which carries a high     risk of mortality. Patients with poor heart and lung function have a higher risk of death     after major cancer surgery. Cardiopulmonary exercise testing, CPET, is an objective measure     of patients' fitness. Most patients, before surgery to resect their cancer, undergo a period     of chemotherapy. Chemotherapy often regresses the cancer but also has adverse effects on cell     function. Our hypothesis is that chemotherapy alters patient fitness, as assessed by CPET,     prior to major cancer surgery. Participating patients will undergo fitness testing by CPET     before and after their chemotherapy, prior to their surgery.   "
148867|NCT01335542|"     There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some     patients receive an epidural analgesia, a femoral nerve block and pills for pain. More     recently, some surgeons have replaced femoral nerve blockade with peri-articular injections.     These patients receive a peri-articular injection (injection of pain medication around the     knee), pills for pain and a pain patch on the skin. The purpose of this research project is     to find out if one of these ways to treat pain is better than the other. The investigators     will look at this question in many ways, but the main way is how long it takes for you to be     judged ready for discharge from the hospital.   "
149187|NCT01331369|"     The aim of the study is to evaluate the effectiveness of a social-psychological intervention     to improve anti-hypertensives adherence in primary care. Its is a pragmatic clinical trial.   "
148868|NCT01335529|"     The majority of Human immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) co-infected     patients are non responders after 48 weeks of the current standard-of-care with     Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of     Boceprevir to the current standard-of-care has been shown to increase the efficacy of therapy     in HCV mono-infected patients previously treated with a bi-therapy. Knowing that HIV/HCV     co-infected patients are subject to more rapid hepatic fibrosis as well as to increased risks     of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is important to     improve the response rate of the re-treatment of hepatitis C in these patients.      The aim of this pilot study is to evaluate the efficacy and safety of Boceprevir in     combination with Peg-Interferon alfa 2b plus ribavirin, in patients co-infected with HIV and     chronic genotype 1 HCV, and previously treated with Peg-Interferon/Ribavirin. 80 subjects     will be enrolled. The primary endpoint will be the Sustained Virologic Response (SVR) defined     as undetectable HCV-RNA at Week 24 after the end of therapy.   "
148869|NCT01335516|"     Terlipressin is an effective and safe treatment for bleeding caused by rupture of oesophageal     varices, which are life-threatening complications of liver cirrhosis.      Oesophageal varices are abnormal dilatation of veins occurring in the lower oesophagus, which     can develop in patients with cirrhosis. Bleeding caused by rupture of these varices is a     life-threatening complication with mortality between 20-50%.      Such bleeding can be treated with drug therapy and/or endoscopic; endoscopic therapy consists     of a flexible tube equipped with a camera at the terminal end, allowing for visualizing and     treating the oesophageal varices.      In this study, investigators will evaluate the safety and efficacy of terlipressin -     Glypressin 1 mg, powder and solvent for solution for injection.      The non-interventional observational study Follow-up of Glypressin (terlipressin) clinical     efficacy in the treatment of bleeding oesophageal varices aims to demonstrate that     administration of Glypressin (terlipressin 1 mg) controls the bleeding in such patients.   "
148870|NCT01335503|"     The aim is to demonstrate how fast and to what extent AN-PEP can degrade gluten in vivo in     the stomach and how much gluten enters the small intestine. A second question is whether the     caloric density of a meal can influence the efficacy of AN-PEP breakdown.   "
148871|NCT01335490|"     The purpose of the study is to understand how cooking might affect the health of pregnant     women and their babies.      The goal of the research is to determine whether, interventions in decreasing exposure to     smoke from cook stoves can bring about a significant change in the indoor air pollution     levels and health of communities in Ghana.      Hypothesis 1. Use of improved cook stoves starting by the third trimester pregnancy will lead     to a significant increase in average birth weight in newborns.      Hypothesis 2. Use of improved cook stoves will lead to a significant reduction in the rate of     severe acute lower respiratory disease during the first 12 months of life.   "
148872|NCT01335477|"     Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in     scarring of the lung and there is a high unmet medical need for effective treatment to halt     lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the     death rate.      In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of     treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of     patients treated with high dose of BIBF 1120 compared to placebo.      Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of     BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will     be conducted as a prospective, randomised design with the aim to collect safety and efficacy     data.      Respiratory function is globally accepted for assessment of treatment effects in IPF     patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is     part of the usual examinations done in IPF patients.   "
149242|NCT01330641|"     This study attempts to determine the most accurate route for injection of the subacromial     bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the     routes of injection is used. It has not been determined if one route is superior, or if all     routes are equal in delivering medication into the subacromial bursa, which sits on top of     the rotator cuff tendons.   "
148873|NCT01335464|"     Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in     scarring of the lung and there is a high unmet medical need for effective treatment to halt     lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the     death rate.      In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of     treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of     patients treated with high dose of BIBF 1120 compared to placebo.      Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of     BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will     be conducted as a prospective, randomised design with the aim to collect safety and efficacy     data.      Respiratory function is globally accepted for assessment of treatment effects in IPF     patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is     part of the usual examinations done in IPF patients.   "
148874|NCT01335451|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     AZD5213 in healthy young and elderly Japanese subjects   "
148875|NCT01335438|"     The purpose of this study is to determine if there are any clinical or radiographic     differences in cemented and cementless fixation in total knee replacement.   "
148890|NCT01335243|"     The main objective of this clinical study is the estimation of the rate of intersomatic     fusion observed 12 months after lumbar interbody fusion by posterior approach with PEEK     interbody cage of fusion in PEEK performed with autologous bone of decortication and osseous     substitute with a biomaterial (MatriBONE associated with the autologous bone marrow),     associated with a posterolateral bone graft performed with MatriBone waxed with bone marrow.     Indication is dedicated for patients by painful degenerative osteoarthritis, by narrow lumbar     canal and\or spondylolisthesis.   "
148891|NCT01335230|"     The purpose of this research study is to explore what role immune cells within the gut (the     sigmoid colon) have locally and on the immune system of patients infected with HCV, HIV or     HCV/ HIV co-infection.   "
149188|NCT01331356|"     The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in     refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in     the ganglion Impar (total dose = 100 units)   "
148876|NCT01335425|"     In clinical practice language impairment is frequently reported in association with nocturnal     epileptiform activity. There is a spectrum of epileptic conditions that are characterized by     nocturnal epileptiform activity. From mild to severe this spectrum involves: Rolandic     epilepsy (RE), nocturnal frontal lobe epilepsy (NFLE), Landau-Kleffner syndrome (LKS) and     electrical status epilepticus during slow wave sleep (ESES). The exact characteristic of the     relationship between nocturnal epileptiform activity and language impairment is yet to be     explored. The investigators suggest that nocturnal epileptiform EEG discharges and nocturnal     epileptic seizures during development will cause diseased neuronal networks that involve     language. The diseased neuronal networks are less efficient compared with normal neuronal     networks.      Objective: Identification of a diseased neuronal network characteristic in children with     nocturnal epileptiform activity, which can explain language impairment in these children. For     this the investigators will use functional magnetic resonance imaging (MRI) to analyse brain     activity and diffusion weighted MRI to investigate white matter connectivity.   "
148877|NCT01335412|"     This is an active electronic surveillance using data from the Defense Medical Surveillance     System (DMSS) to detect and characterize serious, rare adverse events occurring within 42     days after vaccination with the Japanese Encephalitis Vaccine IXIARO within the US Military,     to detect adverse events that occur more frequently after IXIARO and to electronically follow     up pregnancies during or shortly before which IXIARO was administered.      There will be no intervention and no individuals contacted.   "
148879|NCT01335386|"     This is a randomised, assessor-blind, multi-centre pilot study to investigate the comparative     safety and efficacy of KLYX and glycerine enema in the symptomatic treatment of constipation     in Chinese patients.   "
148880|NCT01335373|"     Vaginitis is the most common gynecologic diagnosis in the primary care setting. In     approximately 90 percent of affected women, this condition occurs secondary to bacterial     vaginosis, vulvovaginal candidiasis, trichomoniasis or mixed infection.      Neo-Penotran Forte is registered for treatment of these most common vaginal infections.     Efficacy and safety of this product is already established, and this observational study was     designed to learn more about practical use of Neo-Penotran® Forte in real life setting.   "
148881|NCT01335360|"     This study would be a prospective cohort study, stratified by weight. Patients who are stable     on nevirapine for at least 3 months prior to study entry, but no more than 1year will be     recruited. For 1 week, subjects will take their morning dose of nevirapine in the clinic (and     be observed taking it), and given their evening dose to take at home. Subjects will need to     record the date and time they take their evening dose. At the end of the week, the subjects     will be sequestered at the clinic for blood draws for a 12hr pharmacokinetic sampling. They     will not be brought back in at 24hrs as they will need to be redosed after 12hrs. They will     have Liver Function Tests (LFT's) and other labs drawn at study entry, and one month after     the end of study. Pharmacokinetic levels will be analyzed using standard mathematical models,     and Area Under the Curve (AUC), Maximum concentration (Cmax), and Minimum Concentration     (Cmin) will be compared between groups.   "
148882|NCT01335347|"     The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine     to prevent avian influenza. Volunteers will receive either one or two doses of research     vaccine or placebo as part of this study.   "
148883|NCT01335334|"     The proposed open-label one arm before-after clinical trial will assess the efficacy of a     14-day quadruple therapy containing 420mg of bismuth subcitrate potassium, 375mg of     metronidazole, 375mg of tetracycline hydrochloride (Pylera® packs from Axcan Pharma) and 20mg     of omeprazole in eradicating H. pylori infection in 50 asymptomatic adults in El Paso, Texas.     As part of the study we will obtain specimens for culture of H. pylori in a reference     laboratory.   "
148884|NCT01335321|"     The purpose of this study is to evaluate if the investigators can achieve better early     outcomes adding triamcinolone to the viscosupplementation procedure.   "
148885|NCT01335308|"     BMi 2 is a study that tests a behavioral counseling approach to reduce obesity in children.     Practitioners (Pediatricians, Nurse Practitioners) were randomly assigned to one of three     groups. The first group continued with standard care; in group 2, each practitioner delivered     four study Motivational Interviewing visits with the parent/caregiver, and in group 3 in     addition to the practitioner, a registered dietitian delivered 6 Motivational Interviewing     visits. The primary outcome will be the child's percentile BMI change between the baseline     and 2-year follow-up. Secondary outcomes will include behavior change around fruits and     vegetables, sweetened beverages and exercise. Our hypothesis is that there will be a larger     decrease in BMI percentile for children in group 3 than in group 2, and that children in     group 2 will have a decrease in BMI percentile when compared to group one.   "
149645|NCT01325285|"     The purpose of this study is to determine how intraocular pressure responds to changes in the     levels of carbon dioxide or oxygen that a healthy individual inspires.   "
148887|NCT01335282|"     Traditional Chinese Medicine (TCM) has a history of more than two millenniums. It has been a     common practice in China, Taiwan, Japan and Korea and is becoming increasingly popular     worldwide in recent decades However, there is no general consensus for treatment of many     diseases among TCM practitioners. In some specialties, such as neurology, there is not enough     well documented case reports for practitioners to make reference with. Different     practitioners may give different opinions according to their own experience and patients     often feel frustrated about that.      Therefore, it is worth recording cases of neurological diseases, with accurate western     medicine diagnosis and TCM theory explained. Possible TCM treatments can be suggested     accordingly. Being an academic research supervised by western medicine doctor, this study can     help to suggest more objective opinion with least conflict of interest.   "
148888|NCT01335269|"     The primary objective of this trial is to determine the safety and tolerability of BI 853520     monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for     further trials in the development of this compound.      Secondary objectives are        -  determination of the pharmacokinetic (PK) profile;        -  exploratory pharmacodynamic analysis; and        -  collection of preliminary data on anti-tumour efficacy.   "
148889|NCT01335256|"     Clinical study to determine safety, tolerability, and maximum tolerated dose of BAY1000394     given in 4 week on / 2 week off schedule to patients with advanced solid tumors   "
148892|NCT01335217|"     This is a 20-subject, dose finding study to examine the use of external trigeminal nerve     stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD)     co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant     medications. Our primary objective is the examination of TNS in this patient population.      To accomplish our specific aims, the investigators will test the following specific     hypotheses:        1. Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the          eight-week period.        2. Subjects will show improvement in ratings of life functional capacity and quality of          life with TNS.        3. Subjects will report the TNS treatments to be acceptable in terms of side effects and          burden of using the device.   "
148893|NCT01335204|"     This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with     castration-resistant prostate cancer (CRPC). The current study is designed to determine if     the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or     overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine,     and blood specimens for future research.      This study will enroll patients with CRPC, who have been previously treated with docetaxel or     a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or     may have been previously treated with the agent without definite disease progression during     therapy.      Patients must meet the study eligibility criteria and must be competent to give informed     consent.   "
148894|NCT01335191|"     This protocol represents the third in human study of TUTI-16, and is being conducted to     gather additional safety and human immunogenicity (anti-HIV-1 Tat titers) data of     subcutaneously administered TUTI-16.   "
148895|NCT01335178|"     The goal of this research project is to develop and evaluate an intervention to reduce young     child tobacco smoke exposure   "
148896|NCT01335165|"     The purpose of this research study is to understand the safety, pharmacokinetics and     pharmacodynamics of a single dose of TT30 (ALXN1102 and ALXN1103 formulations) when given IV     (through a vein) or SC (under the skin) to patients with PNH.   "
148897|NCT01335152|"     Stress Management interventions have been shown to decrease cancer-related distress, foster     emotional growth and improve immune functioning during treatment for breast cancer.      This study will evaluate an online version of a stress management intervention for women with     early stage breast cancer. Each chapter of the 10-week intervention include self-assessment     and targeted feedback, education, interactive learning exercises -- all tailored to the needs     of women with early stage breast cancer. In addition, guided writing exercises will promote     emotional expression and a discussion board will encourage group support.      The web-based intervention is being evaluated in a randomized clinical trial with a sample of     120 women with early stage breast cancer. Women will be randomly assigned to use the 10-week     intervention with biweekly telephone assessments or to the telephone assessments alone.   "
148898|NCT01335139|"     The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT,     grass pollen tablets under the tongue) has long term effects in severe hay fever.   "
148899|NCT01335126|"     The purpose of this study is to evaluate the performance between two emulsion-type artificial     tears.   "
148900|NCT01335113|"     The purpose of the investigators study is to determine the relationship between the length of     the eye and the rate of change in eye length at each visit with progression of retinopathy of     prematurity.   "
148913|NCT01334931|"     Coronary angiography exposes patients and physicians to ionizing radiation. The purpose of     this study is to evaluate the routine use of large field of view during image acquisition for     coronary angiography. Patients with indication of diagnostic coronary angiography will be     randomized for the use of either large field of view during image acquisition or medium field     of view. Patients, physician and nurse radiation exposure will be measured by digital     dosimeter.   "
148914|NCT01334918|"     The purpose of this study is to compare Multidetector Computed Tomography (MDCT) and Single     Photon Emission Computed Tomography (SPECT) stress myocardial perfusion imaging (MPI) with     regadenoson in order to detect the presence or absence of reversible defects.   "
152491|NCT01287793|"     Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in     QT/QTc intervals.   "
148901|NCT01335100|"     Background:      Motor impairment limits social and recreational activities in children with cerebral palsy     (CP), compromising participation and impacting on quality of life. Improvement of motor     function by medical treatment may advance in participation of outdoor activities and expand     social and recreational activities. While Botulinum toxin (BTX) injections are effective and     safe treatment for spasticity in children with CP, there is insufficient evidence for     improvement of motor function and enhanced participation in this population.      Objective:      To examine outdoor activity as a functional outcome following lower limb BTX in children with     CP.      Methods:      In this pilot study the investigators will use Global Positioning Systems (GPS) to measure     walking speed, distances, number of walking events and destinations in ambulatory children     with CP following BTX injection to the lower limbs; age and gender matched sibling will be     studied as a control group. Outdoor activity will be measured at 1, 3 and 6 months following     BTX treatment will be compared to baseline and to those of siblings. Outdoor activity will be     correlated with leisure activity preferences and quality of life questionnaires.      Significance: Improvement in outdoor activity following BTX injections in this pilot study     will assist construction of a larger study evaluating participation and quality of life in     children with CP.   "
148919|NCT01334853|"     The rationale for conducting this study is to explore potential clinical and peripheral     biomarkers in subjects requiring daily medium to high dose inhaled corticosteroids for     persistent asthma   "
148920|NCT01334840|"     Water consumption is essential to maintain hydration and good health. Sodium-bicarbonated     mineral waters are reported to have beneficial digestive and hypocholesterolemic properties.     The aim of this study was to investigate the effects of the consumption of a     sodium-bicarbonated mineral water (BW) with or without a meal, compared to a low mineral     content water as a control water (CW), on postprandial serum triacylglycerols (TAG),     cholecystokinin (CCK), and gallbladder volume.   "
148921|NCT01334827|"     The purpose of the study is to compare, contrast, and characterize the range of user     perceptions and potential acceptability of three (3) topical vaginal microbicide dosage     forms.   "
148902|NCT01335087|"     OSA may be a modifiable risk factor for cardiovascular disease due to its association with     hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA     is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce     snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure     and other risk factors for cardiovascular disease. The overall aim of ISAACC is to determine     if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA     admitted in a hospital for an acute coronary syndrome.      Overall objective:      To assess the impact of obstructive sleep apnea (OSA) and its treatment on the clinical     evolution of patients with acute coronary syndrome (ACS).      Primary objectives:      1. To determine if continuous positive airway pressure (CPAP) treatment will reduce the rate     of cardiovascular events (cardiovascular (CV) death, non-fatal events (acute myocardial     infarction (AMI), non-fatal stroke, hospital admission for heart failure, and new     hospitalizations) for unstable angina or transient ischaemic attack (TIA)) in patients with     ACS and co-occurring sleep apnea.      Secondary objectives:        1. Determine the prevalence of OSA in patients who have suffered an episode of ACS.        2. Other secondary objectives will include the effects of CPAP on:             -  To evaluate a composite of CV death, myocardial infarction (MI) and ischaemic               stroke.             -  Components of primary composite endpoints             -  Re-vascularization procedures             -  To evaluate all-cause death             -  To evaluate new onset, ECG-confirmed atrial fibrillation or other arrhythmias             -  To evaluate newly diagnosed diabetes mellitus, according to standard definitions             -  To evaluate OSA symptoms (Epworth Sleepiness Scale (ESS))             -  To evaluate quality of life in patients with ACS (Test EuroQol (EQ-5D).        3. To establish the relationship between the severity and phenotype of patients with OSA          and clinical outcomes of ACS.        4. To establish the relationship between CPAP compliance and CV events incidence.        5. To identify biological risk markers that allow us to establish the most important          mechanisms involved in cardiovascular complications in these patients.        6. To conduct a cost-effectiveness analysis of the diagnosis and CPAP treatment of patients          with ACS who have obstructive sleep apnea.   "
148903|NCT01335074|"     Sorafenib is the standard therapy for advanced liver cancer but often shows dose-limiting     toxicities with the need to reduce the applied dose of the compound. As this limits the     overall response rate of the therapy, a combination with temsirolimus, an inhibitor of mTOR     signaling, will be investigated regarding safety and tolerability in patients with advanced     liver cancer under a reduced dose of sorafenib.   "
148904|NCT01335061|"     The purpose of this study will be to determine if a once-weekly prophylaxis regimen of     BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.   "
148905|NCT01335048|"     The purpose of this study is to evaluate if high-dose (80mg/day) atorvastatin might exert an     adjunctive anti-platelet effect compared to high-dose clopidogrel (150mg/day) in stable     patients with high on-treatment reactivity according to a point-of-care platelet function     assay.   "
148906|NCT01335035|"     This study has been designed to establish the efficacy and safety of deferasirox in patients     with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant     (HSCT).      The purpose of this study is to assess the mean change in serum ferritin after 52 weeks of     treatment with deferasirox, in patients with iron overload (defined with serum ferritin     levels ≥ 1000 ng/ml and receiving > 20 RBC concentrates) after allogeneic HSCT.   "
148907|NCT01335022|"     The investigators seek to demonstrate that interactive physician-led education through     partnership with an African American church will improve awareness and knowledge of     cardiovascular disease in the African American community and will result in objective     improvement in major risk factors associated with cardiovascular disease (CVD).   "
148908|NCT01335009|"     This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess     progression free survival in subjects with metastatic melanoma.      80+ subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into one     of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease     progression.      Subjects must have measurable disease by CT Scan or MRI and must have completed at least one     prior round of chemotherapy.      Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse     Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical     exams/vital signs, tolerability).   "
148909|NCT01334996|"     In this study, the investigators will determine the utility of Tamoxifen, a non-cytotoxic     agent, to improve quality of life, biochemical parameters, and bone marrow involvement in     systemic mastocytosis patients having 1) up to 20% bone marrow infiltration by mast cells     and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard     non-cytotoxic medications regardless of the percentage bone marrow involvement by     mastocytosis. The dose of Tamoxifen will be 20 mg/day and the duration of treatment will be     for one year. Patients currently taking interferon alfa, imatinib mesylate, or cladribine     will be excluded until these medications have been stopped.   "
148910|NCT01334983|"     The purpose of this study is to determine whether a gentle physical conditioning program     comprised of isotonic resistive strengthening and pedometer-directed walking can improve the     physical functioning and fatigue of patients with late stage lung or colon cancer.   "
148911|NCT01334957|"     The primary objective of this study is to determine the safety of a single dose of     intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of     postoperative pain.   "
148912|NCT01334944|"     The primary objective of this study is to determine the safety of a single dose of     intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in     the hospital setting.   "
148915|NCT01334905|"     The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the     pharmacokinetics of YM178 in healthy adult subjects.   "
150676|NCT01311648|"     The objective of the study is to demonstrate the safety and efficacy of treatment with     BAY81-8973 for prophylaxis and breakthrough bleeds in children with severe haemophilia A.   "
148916|NCT01334892|"     Immunosuppression is a key intervention in patients with solid organ transplant and is     usually achieved by combination therapy with systemic CsA or tacrolimus with azathioprine,     mycophenolate mofetil (MMF), or corticoids. However, the outcomes after lung transplantation     are poor when compared with those after heart, kidney, or liver transplantation, with a     survival rate of only 55% for recipients of lung transplants.      Additional application of aerosolised L-CsA should suppress T-cell activation in the lung     tissue and subsequently BOS development. The overall purpose of this phase-II/III study is to     obtain efficacy and safety data of L-CsA in the prevention of BOS.   "
148917|NCT01334879|"     This study investigates the use of a high dose anti-VEGF agent for the treatment of radiation     retinopathy in those patients who have recalcitrant disease.   "
148918|NCT01334866|"     This clinical study has been developed to evaluate the clinical outcomes in patients     undergoing coronary artery bypass grafting via Minimally Invasive Coronary Surgery (MICS); a     minimally invasive coronary bypass procedure that is done on a beating heart via a smaller     chest incision, thus avoiding the invasiveness of the standard procedure.   "
148923|NCT01334801|"     This study is being done to determine whether or not new blood test(s) can determine the     severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral     regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and     tricuspid valve regurgitation associated with pacemaker leads are the cardiac disorders under     study. The blood tests involve analysis for von Willebrand Factor antigen and activity, von     Willebrand Factor multimers, and brain natriuretic peptide (BNP) levels. The results of the     blood tests will be compared to the information from the clinically-indicated echocardiogram     and one blood test compared to another.   "
148924|NCT01334788|"     Chronic sleep deprivation may constitute an important and potentially correctable behavioral     factor in the alarming increase in obesity. There are no definitive experimental studies in     humans showing whether sleep deprivation indeed contributes to increased energy intake and/or     reduced energy expenditure. The investigators propose a series of novel studies to     investigate abnormalities in energy homeostasis imparted by sleep deprivation. The     investigators will measure food intake, energy expenditure (basal metabolic rate, thermal     effect of food, and non-exercise activity thermogenesis), and neurohormone levels in 24     healthy subjects with normal BMI (20-25 kg/m2). Twelve subjects (6 men and 6 women) will be     randomized to sleep deprivation. Measurements will be compared to those obtained in 12     subjects who are randomized to a control group, and are not sleep deprived. The investigators     will test the following hypotheses: 1. That sleep deprivation results in positive energy     balance (increased caloric intake and decreased energy expenditure, as reflected by decreased     non-exercise activity thermogenesis). 2. That dysregulation of appetite and energy     expenditure is associated with changes in molecules controlling appetite and metabolism. 3.     That changes associated with 8 days of modest sleep deprivation resolve, at least in part,     over a 4 day recovery period.   "
148925|NCT01334775|"     Inguinal hernia repair coincides with a high rate of postoperative pain, extending to over a     year in 10-20% of patients. Although this is of major concern, early postoperative pain also     has an important impact on patients and their ability to regain normal work and activities.     Since inguinal hernia repair is the most frequently performed operation worldwide, a small     reduction in loss of workdays can already have significant impact on financial issues. As for     the origin of the pain, it might be the result of local inflammation caused by the mesh     material, but also by nerve entrapment due to fixation techniques. The development of a new     mesh which enables sutureless fixation, Cousin Biotech® Adhesix™, may overcome pain related     to fixation techniques used in the open hernia repair procedure according to Lichtenstein.     Furthermore, the Cousin Biotech® Adhesix™ mesh has already been in use in our institutions     and surgeons familiarized themselves with the application.      The investigators would like to conduct a multicentre randomised controlled clinical trial to     compare the difference in early postoperative pain after unilateral primary inguinal hernia     repair in males. The procedures will be performed in day surgery. Early postoperative pain is     defined as the pain during the first month, with a special interest in the first two weeks.     In addition, the investigators want to measure the possible benefit in terms of time to     return to work, daily activities, quality of life, operation length, complications and long     term postoperative pain.   "
148926|NCT01334762|"     To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with     recently surgically treated minimal to mild endometriosis.   "
148939|NCT01334593|"     Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and     rectal) cancer is associated with improved survival, but also adversely affects physical     fitness, potentially rendering patients unfit for major surgery or increasing the risk of     adverse outcome (death and serious complications) after major surgery. The investigators aim     to obtain pilot data showing that neoadjuvant chemoradiotherapy (NACRT)reduces objectively     measured exercise capacity (fitness).   "
148940|NCT01334580|"     This study involves the comparison of two treatment approaches for patients with chronic pain     who are entering methadone maintenance treatment (MMT) for opioid addiction: (a) an     integrated counseling that addresses both chronic pain and opioid dependence(POD)and (b) a     counseling intervention that addresses opioid dependence only.   "
148927|NCT01334749|"     The primary aim of the DEDEMAS (Determinants of Dementia After Stroke) study is to identify     predictors of post stroke dementia (PSD). A particular focus will be on biological markers     (neuroimaging, biochemical markers derived from blood) and on interactions between vascular     and neurodegenerative mechanisms. For this purpose patients with an acute stroke and without     prior dementia will be followed for 60 months.      Note: Starting from 01.01.2014 this study is expanded to a multi-centric design funded by the     German Center for Neurodegenerative Diseases (The DZNE - Mechanisms of Dementia After Stroke     (DEMDAS) Study). This includes the following study sites: DZNE/München - Institute for Stroke     and Dementia Research, Klinikum der Universität München (Coordinator); DZNE/Berlin -     Neuroscience Research Center - Campus Mitte Charité; DZNE/Bonn - Klinik und Poliklinik für     Neurologie, Universitätsklinikum Bonn; DZNE/Göttingen - University Medical Center Göttingen;     DZNE/Magdeburg - Universitätsklinikum Magdeburg.   "
148928|NCT01334736|"     Cigarette smoking is very common in current and former injection drug users and is known to     cause chronic lung diseases. Quitting smoking is proven to improve the health of people     addicted to cigarettes. . Little information exists regarding the perceptions and     characteristics of drug users regarding quitting smoking. Additionally, most programs     designed to help people quit smoking are not very successful. One reason these programs may     not work well is because it is difficult to motivate people to quit smoking. New methods of     motivating changes in behavior include small monetary payments for healthy behavior and     reporting breathing tests with the concept of lung age, which is the age of an average     healthy person with similar breathing test results. For example, a health care provider can     report results as Although you are 50 years old, you have the lungs for a 70 year old. In     this proposal, the investigators plan to first explore the beliefs and characteristics of     current and former injection drug users and how they are related to quitting smoking. The     investigators then plan to study whether the use of two new methods of motivation increases     the chances that this group will stop smoking.   "
149189|NCT01331343|"     The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian     RT glucose sensor can improve glycemic control over a 12-week period, compared to patients     using self-monitoring blood glucose testing (SMBG) alone.   "
148929|NCT01334723|"     This retrospective study aims to quantify the relationship between 5-alpha-reductase     inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention     (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the     economic impact associated with these medical encounters. The Integrated Health Care     Information Solutions (IHCIS) database will be utilized for this study (2000-2006).   "
148930|NCT01334710|"     The purpose of this study is to evaluate the effect of combining a new investigational drug     (OSI-906) with a standard drug (sorafenib) on the control of liver cancer (Hepatocellular     cancer). Sorafenib (brand name Nexavar®) is a drug that is approved for the treatment of     advanced liver cancer. It works by stopping the growth of new blood vessels around the tumor.     OSI-906 is an investigational agent that works by inhibiting the effects of a growth hormone     on the cancer. The safety and efficacy of combining OSI-906 and sorafenib in the treatment of     liver cancer risk not known. The current study will confirm the safety of the combination in     the first six patients and evaluate the activity of the combination in patients with advanced     liver cancer.      In addition, the study will aim at collecting blood samples from patients to evaluate the     level of OSI-906 in patients receiving the combination of the two drugs. The study also will     collect samples of the tumor to evaluate for markers that can predict in which patient the     combination is effective.   "
148931|NCT01334697|"     The general aim of the study is to determinate safety, tolerability and early     pharmacokinetics of cardiotrophin.1 in healthy volunteers.   "
148932|NCT01334684|"     Our general aim is to investigate whether messenger RNA (mRNA) and/or microRNA (miRNA)     expression profiles in white blood cells, predict metformin monotherapy efficacy in patients     with type 2 diabetes.   "
148933|NCT01334671|"     The purpose of this study is to evaluate the clinical effect of intensive statin therapy     before emergency PCI in patients with STEMI.   "
148934|NCT01334658|"     This is a study aimed at evaluating the effectiveness and impact of two intraocular     irrigating solution (BSS ® versus glucose-bicarbonate-Ringer Lactate - GBRL) on the health of     the cornea after cataract surgery by phacoemulsification.   "
148935|NCT01334645|"     The purpose of this study is to determine whether the combination of copeptine and troponin     adds diagnosis information to that provided by troponin alone or the combination of troponin     and myoglobin.      Hypothesis : If the values of troponin and copeptin are not elevated, diagnosis of acute     myocardial infarction can be ruled out without prolonged monitoring and serial blood     sampling.   "
148936|NCT01334632|"     Brachial plexus injury after shoulder surgery with continuous interscalene block is 2.4% at 1     month and 0% at 6 months, but may be higher with a systematic postoperative neurological     examination. Indeed, femoral neuropathy after anterior cruciate ligament reconstruction is     24% at 6 weeks in a cohort of 20 consecutive patients systematically screened with an     electromyogram. Brachial plexus injury may be the consequence of the surgery (direct lesion     by traction) or the continuous interscalene block. The goal of this study is to define the     etiology of this postoperative neuropathy.   "
148937|NCT01334619|"     The retrograde infraclavicular brachial plexus block has been proved an effective and safe     approach. Realtime ultrasound guide will facilitate a successful peripheral nerve block. The     purpose of this study was to determine the medium effective volume required to produce an     effective retrograde infraclavicular block using an ultrasound (US)-guided technique.   "
148938|NCT01334606|"     The primary purpose of this study is to demonstrate that the BD 4mm x 32G Ultra-Fine Nano pen     needle provides equivalent glycemic control to the BD 8mm x 31G Ultra-Fine short pen needle     as measured by fructosamine (FRU) among Lantus®, Levemir®, and/or NPH users taking one or     more single daily injections of greater than 40 units of insulin.      Glycemic control, injection pain, leakage, preference, comfort, and other parameters will be     compared between the 4mm x 32G and the 8 mm x 31 G pen needle after three weeks of use of     each device. Sufficient numbers of subjects taking Lantus® as their basal insulin will be     enrolled so as to allow for pre-specified analysis of this subgroup.   "
148941|NCT01334567|"     The purpose of this study is to offer subjects from centers in Taiwan who successfully     complete 168 weeks of treatment in study GS US 174-0108 access to treatment with tenofovir DF     for up to three additional years (144 weeks). Subjects will be followed per local standard of     care. Serious adverse events (SAEs), drug accountability and patient disposition will be     recorded.   "
148942|NCT01334554|"     Obesity has a greater detrimental impact on the health of African American women than on any     other racial or gender group. Nearly 80% of African American women are overweight or obese in     the United States. Hypertension and insulin resistance are more prevalent among African     American women as compared to men and Caucasians. These conditions put them at increased risk     for the development of diabetes mellitus and cardiovascular disease.      Recent studies have reported that a substance named Nitric Oxide (NO)may have some beneficial     effect on how the body handles blood sugar and blood pressure. Of interest,some studies have     shown that African Americans have decreased function of NO in their blood vessels.      In this study proposal the investigators will test if increasing NO function with a PDE-5     inhibitor (sildenafil citrate) will improve pre-diabetes and the health of the inner layer of     the blood vessels in obese African American women.   "
148943|NCT01334541|"     The investigators propose to evaluate Suicide Assessment and Follow-up Engagement: Veteran     Emergency Treatment (SAFE VET) which is currently being implemented in 4 VA ED/Urgent Care     Units across the United States (Portland VA Medical Center (VAMC), Denver VAMC, Manhattan     VAMC, and Philadelphia VAMC).   "
148944|NCT01334528|"     The purpose of this project is to explore the degree to which performance consistency on     neuropsychological measures varies in a sample of Operation Iraqi Freedom (OIF)/Operation     Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with     persistent self-reported symptoms.   "
148945|NCT01334515|"     This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works     when given together with sargramostim and isotretinoin in treating patients with relapsed or     refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and     sargramostim work in different ways to stimulate the immune system and stop tumor cells from     growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     hu14.18-IL2 fusion protein together with sargramostim and isotretinoin may kill more tumor     cells.   "
148946|NCT01334502|"     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer cells in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Drugs used in     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and     prednisone, work in different ways to stop the growth of cancer cells, either by killing the     cells or stopping them from dividing. Giving everolimus together with rituximab,     cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone may kill     more cancer cells.      PURPOSE: This phase I trial is studying the side effects and the best dose of everolimus when     given together with rituximab and combination chemotherapy in treating patients with newly     diagnosed untreated diffuse large B-cell lymphoma.   "
148947|NCT01334489|"     Placing a cervical pessary in severe twin-to-twin transfusion syndrome (TTTS) cases treated     by fetoscopic laser coagulation (FLC) decreases the spontaneous preterm birth rate.   "
148948|NCT01334476|"     The VISN 19 MIRECC is involved in research concerned with suicide prevention in high risk     populations (e.g., history of traumatic brain injury, post-traumatic stress disorder);     Recruitment for future studies will continue with a similar focus. The aim of this protocol     is for the VISN 19 MIRECC Research Database (V19-MRD), to have a data repository of     participants for possible recruitment from other studies being conducted at the VISN 19     MIRECC. The VISN 19 MIRECC conducts numerous research projects under the review of COMIRB and     the VA R&D.   "
148949|NCT01334463|"     1. To determine whether tasks taken from the field of cognitive neuroscience can detect and          distinguish impairments in executive function above and beyond standard          neuropsychological measures in individuals with: a.) Mild Traumatic Brain Injury (TBI),          b.) Post Traumatic Stress Disorder (PTSD), c.)Mild TBI+PTSD        2. To determine whether performance on these tasks is linked to pertinent psychiatric          outcomes (e.g. history of suicidality), which is associated with compromised executive          function and impulsivity.        3. To determine whether information regarding brain anatomy can provide additional          information above and beyond behavior performance in distinguishing between these two          groups.   "
148950|NCT01334450|"     Transcranial Magnetic Stimulation (TMS) for treatment of Alzheimer disease.   "
148951|NCT01334437|"     Intend of use: A blood test for Cancer Associated Antibodies (CAAA) is an aid in initial     diagnosis of ovarian cancer in women with suspected ovarian pathology as detected by primary     diagnostic techniques.      Test Description: Blood is collected from patients and serum/plasma is tested for the     presence of CAAA on experimental test kit.      Objectives: To assess the effectiveness of the CAAA test.      Target Population:      The study population will include women that have been diagnosed with suspected ovarian     cancer (OC), verified by pathology/cytology as patients, women with suspected ovarian cancer     but verified by pathology/cytology as non-cancers and a control set of blood samples will be     collected from age matched women with no history of cancer.      Structure: Women that will be enrolled for the study will be checked for the presence of     CAAAb, and the results of the CAAAb test will be compared to the pathology submitted by the     physicians in the participating centers for the patient population and to the clinical     history for the control population.      Sample Size: The investigators will collect at least 50 patients verified by     pathology/cytology and for each patient at least two aged matched healthy controls and two     aged matched suspected but verified as non-cancers. Total amount at least 250 samples.      (Multi center study, statistical rationale provided below).      Primary Effectiveness Variables: The effectiveness of the test will be defined by the     specificity of the test conditionally that the sensitivity is not lower than a pre-defined     level of 95%.      Endpoint: The endpoint of this study is to show that the effectiveness is higher than 50%.      Clinical Monitor: For each site a dedicated CRO will be appointed to monitor the clinical     trials. All data will be stored in a protected internet-based database, and any changes of     the data will be traced and recorded.   "
148952|NCT01334424|"     Gut hypoperfusion - reperfusion injury is an unavoidable event at the end of laparoscopic     surgery. It produces oxidative stress (reactive oxygen species). Malondialdehyde have been     demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.     Propofol (2, 6 - diisopropylphenol), a highly liposoluble anaesthetic, has a potent     antioxidant activity against lipid peroxidation in both in vitron and in vivo studies. On the     basis of this knowledge, the investigators hypothesized that propofol has preventive effect     for gut hypoperfusion - reperfusion induced injury in robot-assisted laparoscopic radical     prostatectomy.   "
149006|NCT01333722|"     The primary purpose of this study was to evaluate analgesic efficacy and safety of     hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate     to severe pain following bunionectomy.   "
149007|NCT01333709|"     The purpose of this study is to determine whether the tailored management of locally advanced     rectal carcinoma can improve the oncologic and functional outcome.   "
148953|NCT01334411|"     Aim: To identify examples of surgeons good and poor intraoperative behaviours related to safe     and efficient surgery.      Methods: Ten observations will undertaken in the operating theatres of Rigshospitalet and     Herlev Hospital with the researchers taking field notes. This provides the Ph.d student with     empirical background knowledge of observed surgical behaviour as well as an understanding of     surgical culture. The knowledge will be used to qualify the interviewguide.      8 semi-structured group interviews and 3 individual interviews will be conducted and tape     recorded. The interviews will be led by the Ph.d student with an anesthesia nurse present as     a co-moderator. The groups will contain 4 - 12 participants.      The interview guide will be developed with a Scottish behavioural marker system as a     framework, drawing upon the literature as well as the observations. It will contain questions     regarding leadership, communication, teamwork, situation awareness and decision making to     facilitate a discussion about surgeons' good and poor behaviours.      Material: Data will be collected in two hospitals in the capital Region of Denmark,     Rigshospitalet and Herlev Hospital. Each hospital will provide four focus groups, one     containing consultant surgeons in general surgery, one trainee surgeons, one scrub nurses and     one containing a mixture of anesthetists and anesthesia nurses. The two latter focus groups     is included to get the perspectives of the surgeons' team members since international studies     have demonstrated differences of opinion regarding the perceived quality of teamwork amongst     operating theatre staff. This study will be the first to build in the opinions of the team     members into a behavioural marker system. 3 individual interviews with surgeons will     afterwards conducted in one of the hospitals to get a more in-depth discussion.      Data analysis and statistics: The interviews will be fully transcribed and analysed using     qualitative method of systematic text condensation. Power calculations are not relevant in     this qualitative study. Accepted guidelines state that the number of participants in each     group should range between 5 and 15 and the data are from two large university hospitals     receiving different patient categories to ensure a certain representative sample of     informants.   "
148954|NCT01334398|"     The primary goal of the proposed study is to evaluate the efficacy of a replicable     community-based group intervention, designed to address both general wellness and specific     TBI health-related issues. Emphasis is placed on goal setting to develop healthy habits,     utilizing problem solving strategies, learning means of maintaining progress and setting new     goals. Facilitators will utilize approaches aimed at maximizing participant self-efficacy,     reducing barriers to health promotion, and developing personal resources. A randomized     wait-list control group design will be used to evaluate the efficacy of the intervention. It     is hypothesized that individuals with TBI who participate in the intervention group will     report increased health promoting behaviors, health related self-efficacy, health-related     quality of life, level of participation, and greater perceived wellness and satisfaction with     life as compared to the control group.   "
148955|NCT01334385|"     Veterans possess significant risk factors for self-directed violence (SDV). For example,     depressed Veterans are at a greater risk for SDV than the general population. Although     depressed male Veterans die by suicide at a higher rate than do their female counterparts     (Zivin et al., 2007), female Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF)     Veterans are at higher risk for depression than males (Seal et al., 2009). Joiner's (2005)     theory states that suicidal individuals (a) perceive themselves to be unbearable burdens onto     others; (b) view their efforts at establishing and maintaining social connections as having     been thwarted or failed; and (c) have developed the ability to engage in SDV due to from     increased habituation to pain. This two-part study uses semi-structured interviews in an     effort to determine the extent to which Joiner's theory is applicable to OEF/OIF Veterans.     Part I of this study, which has been completed, assessed the components of this theory among     primarily male OEF/OIF Veterans. Part II of this study is assessing this theory's components     among female OEF/OIF Veterans. Participants were recruited from the female OEF/OIF Veteran     population receiving services through the Eastern Colorado Health Care System (ECHCS).     Comparisons across the interview responses will be made to identify commonalities among the     participants' experiences.   "
148956|NCT01334372|"     This investigation is a feasibility study conducted in a VA outpatient treatment setting. The     study is designed to test the feasibility of implementing a novel way of working with     suicidal patients, the Collaborative Assessment and Management of Suicidality (CAMS). The     primary purpose of the proposed project is to determine if it is possible to train clinicians     working in the Mental Health Clinic at the Denver VA Medical Center (VAMC) to utilize this     therapeutic framework. This project is extremely timely in relation to expectations of future     increased clinical demands among potentially high-risk Operation Enduring Freedom/Operation     Iraqi Freedom (OEF/OIF) veterans who may become suicidal in the years to come.   "
148957|NCT01334359|"     Recent trends have identified decreasing levels of physical activity, fitness, and health in     preadolescent children. Examining factors, such as physical activity behavior and aerobic     fitness that positively influence cognitive health of school-age children are important for     improving school performance, maximizing health, and improving the overall functioning of     individuals as they progress through the human lifespan. A sample of preadolescent children     from the Urbana, Illinois elementary school system will be randomly assigned to a 9- month     afterschool program that focuses on either aerobic exercise or wait-list control group to     determine the effects of physical activity on basic and applied aspects of cognition. Changes     in neuroimaging and behavioral indices of cognitive function and performance on standardized     academic achievement tests of mathematics and reading will be examined as a function of     participation in the intervention. Preliminary research supports that physical activity is     positively associated with basic and applied aspects of cognition, with a stronger     relationship for tasks requiring extensive amounts of executive control. However, previous     research has mainly focused on older adults, and little research has examined the     relationship between physical activity and executive control in children. These findings will     provide lifestyle considerations for children to improve their cognitive health across the     lifespan.   "
148958|NCT01334346|"     The following study proposes to investigate the injury risk associated with the use of a new     category of running footwear: the minimalist shoe. A group of experienced adult male and     female runners with neutral foot types will take part in this study. All participants will be     randomized to receive one of three different shoes: a full minimalist shoe (Vibram     5-Fingers), a partial minimalist shoe (Nike Free 3.0) and a conventional neutral supportive     running shoe (Nike Pegasus), while training for a 10k event over a 14-week period. Outcomes     to be investigated are pain, footwear perception, and number of injury events.      The hypothesizes is that participants using the minimalist footwear during their running     program will experience a reduction in running related pain. A greater degree of footwear     minimalism will result in a greater reduction in pain (compared to the partial minimalist     shoe, Nike Free).   "
149008|NCT01333696|"     The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as     salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and     neck.   "
150677|NCT01311635|"     The purpose of this study is to study the relative bioavailability of AZD1981 when using a     new tablet compared to the current tablet.   "
148959|NCT01334333|"     A critical aspect of real-world functioning following kidney transplantation involves how     adherent individuals are to their medication regimens. Regardless of the possible dangers of     failing to adhere to anti-rejection medications, such as increased graft rejection, studies     have reported rates of non-adherence at almost 50% following renal transplant.      The Cognitive Aging Laboratory under the direction of Dr. Wendy Thornton, at Simon Fraser     University, has previously identified relationships between several potentially important     cognitive and psychosocial variables, and self-reported medication adherence in renal     transplant recipients, including depressive symptoms, as well as everyday and traditional     cognitive functioning [4]. The possibility that changes in dosing regimens for a given     medication may have an additional impact on medication adherence presents an important issue     worth further exploration.      The current study will allow for more thorough delineation of the roles of psychosocial and     cognitive predictors of adherence with state-of-the-art monitoring techniques. In addition,     the investigators will assess whether different dosing formulations of tacrolimus impact     adherence behaviors in renal transplant recipients.      The proposed research has two primary aims to examine:        1. To examine the role of cognitive and psychosocial variables in predicting medication          adherence in renal transplant recipients.        2. To examine whether different formulations of tacrolimus (once per day dosing versus          twice per day dosing) will impact medication adherence in renal transplant recipients.   "
148971|NCT01334177|"     This phase I trial studies the side effects and best dose of TLR8 Agonist VTX-2337 when given     together with cetuximab in treating patients with locally advanced, recurrent, or metastatic     squamous cell cancer of the head and neck (SCCHN). Biological therapies, such as TLR8 Agonist     VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing.     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Giving TLR8 Agonist VTX-2337 together with     cetuximab may kill more tumor cells.   "
148960|NCT01334320|"     Controversy over surgical treatment of clinically negative neck in early stage oral squamous     cell carcinoma revolves around the uncertainty of its impact on patient prognosis. The     efficacy of elective neck dissection on prognosis in T1, 2 N0M0 patients continues to be the     subject of clinical debate. Currently the clinically negative patients are treated by one of     the two main policies: one is elective neck dissection; the other is watchful waiting. The     objective of this multi-institutional prospective randomized controlled study is to evaluate     the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with     carcinoma of oral cavity. The enrolled patients with T1, 2 N0M0 oral cancer will be     randomized into two groups: elective neck dissection versus watch and wait. The survival rate     and the recurrence rate between two groups will be compared. The result of the study will     give surgeons evidence-based instructions for the management of clinically negative neck in     patients with cancer of oral cavity.   "
148961|NCT01334307|"     The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc.     Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx,     Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.   "
148962|NCT01334294|"     ForeseeHome, an FDA-approved home device, was specifically designed for unsupervised     Preferential-Hyperacuity-Perimeter (PHP) testing of Age Related Macular Degeneration (AMD)     patients at home by characterizing central and paracentral metamorphopsia . The purpose of     the current study is to evaluate if, in post-treatment patients, PHP parameters as measured     with the ForeseeHome are in agreement with clinical decisions and retinal characteristics as     measured with optical coherence tomography (OCT).   "
148963|NCT01334281|"     This study is being done because the study doctor is trying to develop a new test which will     help transplant doctors monitor patients with high panel reactive antibodies (PRA). The test     would be used to monitor patients' PRA when doctors are trying to lower it through a process     known as desensitization. Desensitization lowers high PRA levels and allows patients to     receive transplants. This is a single center study to evaluate and optimize the use of a new     laboratory test to detect and measure the immune system's functioning.   "
148964|NCT01334268|"     The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9     months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and     the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System     compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer     patient population requiring stent implantation.   "
148965|NCT01334255|"     LT1009-Oph-002 is a Phase 1b study designed to evaluate the safety and potential efficacy of     iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of     Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related     Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV).   "
148966|NCT01334242|"     The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to     meals in healthy subjects.   "
148967|NCT01334229|"     Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-IV), and has     been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes     mainly through incretin hormone-mediated improvements in islet function [13]. Although     clinical studies to date indicate that fasting lipid levels are minimally affected by DPP-IV     inhibitor treatment [14-16], animal studies suggested that DPP-IV inhibition reduce     intestinal triglycerides (TG) absorption and apolipoprotein (apo) production [17] and     increased chylomicron catabolism [18]. Interestingly, a recent study supporting this     hypothesis showed that vildagliptin therapy was able to reduce postprandial intestinal     triglyceride-rich lipoproteins (TRL) particles in patients with type 2 diabetes [19].     Recently, our group has reported that sitagliptin treatment significantly reduced plasma apo     B-48 and TG concentrations in the postprandial state. Moreover, animal studies showed that     sitagliptin decreased intestinal secretion of intestinal apo B-48, mainly by increasing level     of glucagon-like peptide (GLP)-1 [20]. Therefore, the present study was designed to examine     the effects of sitagliptin on the kinetics of TRL apo B-48 and in patients with type 2     diabetes. A possible reduction in postprandial atherogenic TRL apo B-48-containing     lipoprotein levels by sitagliptin would add to therapeutic utility of this DPP-4 inhibitor     and suggest the potential to reduce cardiovascular risk in patients with type 2 diabetes.   "
148968|NCT01334216|"     The CHICA system is a clinical decision support system that uses adaptive turnaround     documents to provide point-of-care information to clinicians. The investigators will be     studying whether it can help to support parents in their efforts to quit smoking.   "
148969|NCT01334203|"     This study will evaluate the efficacy of ranolazine compared to placebo on duration of     exercise assessed by exercise tolerance testing (ETT) at anticipated peak ranolazine plasma     concentration after 12 weeks of treatment in subjects with chronic stable angina and coronary     artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM).   "
148970|NCT01334190|"     This will be a non-comparative prospective observational study of women using Zarin as a     primary method of contraception in Kenya. It will be conducted in close collaboration with     the Kenya MoH in several MoH-affiliated clinics that have experience with implants and     sufficient expected flow of implant users per month. The investigators will enroll a total of     600 women divided into two cohorts in this one-year prospective study:        -  a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months          after enrollment; and        -  a surveillance cohort of 300 women who will report back to the clinic during 12 months          after enrollment only if they have complications, medical problems, pregnancy, or want          to remove the implant      The main study outcomes are pregnancy, immediate and delayed complications associated with     insertion or removal, adverse events, early discontinuation and reasons for discontinuation,     and level of women's satisfaction with Zarin services.   "
149042|NCT01333254|"     The aim of the project is to evaluate differences between intermittent and indwelling     catheterisation in patients with hip surgery.      Specific objectives are to determine whether:        -  frequencies of urinary tract problems in hospital and up to one year after discharge          differ between patient groups treated with intermittent and indwelling catheterisation          respectively.        -  costs and health-effects differ between the patient groups.        -  experiences of urinary catheterisation differ between the patient groups   "
148972|NCT01334164|"     The proposed study is designed to test the effectiveness of recovery management checkups for     women offenders (RMC-WO) released from jail to provide continuity of care immediately upon     release and to help them manage their long-term recovery. The hypotheses in the first phase     were: 1)women assigned to RMC (versus control) will a) return to treatment sooner after the     initial release from jail and b) be more likely to receive treatment in the 90 days after     release from jail; 2)women who received treatment in the first 90 days post release (vs. no     treatment) will be more likely to sustain their abstinence through 90 days post release from     a) any alcohol or drugs, b) alcohol, c) cannabis, d) cocaine, and e) opiates; 3)women who     maintained their abstinence from any alcohol and other drugs through the first 90 days post     release (vs. any relapse) will be less likely to have a) unprotected sex, b) commit any other     illegal activity, and d) be re-incarcerated in jail or prison. In the second phase repeated     exposure to these efforts on a quarterly basis is expected to further strengthen each of     these effects.   "
148973|NCT01334151|"     The primary objective of this study is to assess the speed of absorption and onset of action     of BIOD-105 and BIOD-107 and compare them to Humalog®.   "
148974|NCT01334138|"     There is strong evidence that our current consumption of salt is the major factor increasing     blood pressure (BP). The current salt intake in most countries in the world is 9 to 12 grams     per day (g/d), whil the World Health Organization's recommendation is < 5 g/d.      The aims of the present study is to determine if the overconsumption of salt influences the     bp in patients with uncontrolled hypertension or frequently elevated bp.      Each study subject will complete questionnaires, and their usual dietary salt intake is     estimated from food composition on 3 completed food diaries. This is also compared with a     24-hour urine sample collection.      Based on these results, the study subject receives personal advice to decrease sodium     consumption and will change the diet for at least 28 days. During this diet, bp will be     measured and food diaries will be completed. After the intervention, a questionnaire and a     24-hour urine sample collection will be collected.   "
148975|NCT01334125|"     The significance of this project is to investigate the effects of adjunctive metformin     therapy in children and adolescents with double diabetes. Double diabetes describes a     clinical state where an individual possesses features of both type 1 and type 2 diabetes.     There is a paucity of data on the role of adjunctive metformin therapy in children and     adolescents with double diabetes. To help fill this knowledge gap, the investigators propose     a randomized, double-blind, placebo-controlled trial of metformin in double diabetes.     Specifically, the investigators will evaluate changes in hemoglobin A1c and anthropometry in     patients with a diagnosis of type 1 diabetes who also have features of type 2 diabetes or     metabolic syndrome as well as patients with type 2 diabetes who possess diabetes-associated     autoantibodies. This will help determine the safety profile, and efficacy of adjunctive     metformin therapy in these subjects.   "
148976|NCT01334112|"     The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the     treatment of unresectable/metastatic hepatocellular carcinoma (HCC)   "
148977|NCT01334099|"     The purpose of this study is to determine the maximum dose of CP-675,206 when given in     combination with radiation. Patients will be given local radiation to one tumor site and an     intravenous infusion of CP-675,206.   "
148978|NCT01334086|"     Chemotherapy induced nausea and vomiting (CINV) is a major adverse effect of chemotherapy.     This study is determining the incidence of vomiting/retching of the standard induction     chemotherapy regimen for patients with acute myeloid leukemia (AML) who are also receiving an     antiemetic known as aprepitant.      The standard frontline chemotherapy for patients with AML consists of cytarabine given as a 7     day continuous infusion plus 3 days of an anthracycline, most commonly daunorubicin, on days     1-3. This is known as the 3+7 regimen. Antiemetic treatments are usually given to patients     for nausea and vomiting. Granisetron (a 5-HT3 receptor antagonist) is used on the 3     daunorubicin days and other antiemetics can be used for breakthrough nausea/vomiting.      This study will test that the prophylactic use of aprepitant, in addition to the standard     antiemetic regimen used at Princess Margaret Hospital (PMH), will reduce the incidence of     delayed onset vomiting/retching by Day 5 in AML patients receiving the standard 3+7 regimen,     compared to retrospective data using this regimen.   "
148979|NCT01334073|"     The aim of the study is to determine the MTD of the combination of everolimus plus axitinib     in solid tumors, especially RCC.   "
149009|NCT01333683|"     Many authors link tinnitus to arterial hypertension. The aim of this study is to establish a     possible relationship between them, analyze the severity of tinnitus related to arterial     hypertension and analyze a possible influence of ototoxic drugs used to treat arterial     hypertension   "
149010|NCT01333670|"     The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution     compared with standard isotonic solution on infammation reduction and wound bed cleansing of     chronic pressure or vascular leg ulcers.   "
148980|NCT01334060|"     The study is not currently recruiting new subjects due to an interruption in funding from its     sponsors. Efforts are under way to re-establish funding, however, the study is currently     on-hold pending the outcome of these re-funding efforts. There have been no safety concerns     identified during the study      This is an open label, single dose level, phase II study in two patient groups (CML and AML)     using genetic randomisation. Consented and eligible HLA A2+ve patients will be vaccinated     with two DNA vaccines and HLA A2 -ve patients will be followed up with molecular monitoring     only. The objectives are to evaluate: 1) Molecular response following p.DOM-epitope DNA     vaccination in patients with CML (BCR-ABL, WT1) and AML (WT1) at weeks 4, 8, 12, 16, 20 and     at months 6, 12, 18 and 24. 2) Time to disease progression, 2 year survival rate (patients     with AML) 3) Correlation of molecular responses with immunological responses. Primary     Objective: CML: Molecular response of BCR-ABL. AML: Time to disease progression. Secondary     Objective: Molecular response of WT1 transcript levels, immune responses to WT1 and DOM,     Toxicity, CML-Time to disease progression, next treatment and survival, AML-2 year survival,     overall survival   "
149151|NCT01331837|"     This randomized, open-label, parallel-group, multicenter study will evaluate the rate of     cardiovascular events with tocilizumab in comparison to etanercept in participants with     rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8     milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg)     etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug     (DMARD).   "
148981|NCT01334047|"     In this study the investigators will include patients with relapsed epithelial ovarian     cancer. In spite of increased rates of complete response to initial chemotherapy, most     patients with advanced ovarian cancer relapse and succumb to progressive disease.     Immunotherapy may have potential for consolidation therapy. Dendritic cell vaccine is well     toleranted in previous studies, with minor side effects and no serious adverse events     registrated In this study, patients will receive DC-vaccine therapy after response to     platinum treatment at relapse. The investigtors include patients in good clinical condition     with no severe symptoms of the disease. If patients relapse during vaccine treatment, they     will be discontinued from the study.      The investigators have included hTERT- and survivin mRNA in addition to amplified cancer stem     cell mRNA in the vaccine.   "
148982|NCT01334034|"     This trial is conducted in Europe. The aim of this trial is to investigate the safety,     tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the     pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as     tablets in healthy subjects.   "
148983|NCT01334021|"     The goal of this research study is find out if researchers can use genetic testing on tumor     samples to predict if tumors will respond to breast cancer treatments. The tumor sample will     be tested to learn if certain genes are activated (turned on) in the tumor. Researchers hope     that the activation of these genes may predict if the tumor will be sensitive or resistant to     routine breast cancer treatments, such as chemotherapy or hormonal therapy.   "
148984|NCT01334008|"     Circulating tumor DNA detection and quantification in patients with metastatic choroidal     melanoma.   "
148985|NCT01333995|"     Child undernutrition remains a highly prevalent condition in low and middle income countries     and a major portion of the global burden of childhood malnutrition is found in South Asia     with an estimated 74 million children living with chronic malnutrition (stunted growth) in     this region. This burden of malnutrition accounts for approximately 50% of under five child     deaths in developing countries. The risk of child death is also related to the severity of     malnutrition and progressively increases the more the child's growth deviates from WHO Growth     Standard, e.g. children with height-for-age <-3 Z scores from the standard have a four fold     increased mortality risk compared to children within one Z score of the growth standard mean.     Underweight in children for 18.7% of the global disability-adjusted life years in children     less than five years of age. Childhood malnutrition is a pervasive problem in Bangladesh with     43% of children less than five years stunted in 2004 and 38% in urban child populations. An     establish approach to promoting appropriate breastfeeding practices is through the use of     local peer counsellors to provide information and to support to mothers. A recent study has     conducted on pioneering research on this approach in Bangladesh.. The main aim of the study     is to use a Cluster Randomized Control Trial (CRCT) to collect high-level evidence of whether     peer counselling of women to promote appropriate breastfeeding and complementary feeding can     improve feeding practices, child growth and reduce the prevalence of malnutrition in their     children.      The investigators will use a community-based Cluster Randomized Control Trial (CRCT) to     examine the impact of a peer counselling infant feeding education program starting in the     third trimester of pregnancy to one year after delivery, to improve child feeding practices,     child growth and reduce the prevalence of malnutrition in their children. This will result in     two study groups. The outcome assessments will be made on a cohort of infant-mother dyads     measured at baseline and at follow up visits because the investigators expect a likely high     correlation between baseline and follow up outcome measures, thus making this approach the     most efficient study design. Outcome assessments will be conducted with all the mother-infant     pairs recruited in the community clusters in the study, with an expected total of 1950     mother-infant days (975 in each treatment group). The peer counseling education will be     offered to eligible pregnant women identified by household surveys over 3 months in each     community cluster in the intervention group. Using a similar approach to recruitment, a     cohort of mother-infant dyads, who will receive standard maternal and child health care     programs, will be identified in the control clusters.      Data will be collected on anthropometry, feeding practices and hygiene and caring practices     etc. The investigators will report the results for 2-sided 5% tests for the primary trial     outcome. Secondary analyses will examine each outcome variable (stunting, height-for-age,     feeding patterns, and mean nutrient intakes) taking account of the repeated measurements     within children by using separate mixed models. The investigators will use linear mixed     models for continuous outcomes (e.g. height-for-age Z) and generalized linear mixed models     for non-continuous outcomes (e.g. logistic mixed models for binary outcomes e.g. percentage     exclusively breastfeeding). It is expected that the publications from this research will have     substantial impact on child health and will help with the development of public health     nutrition policies for children in South Asia and will be widely cited.   "
148986|NCT01333982|"     More than half of under-five deaths in Bangladesh occur in the first month of life (neonatal     period), and a substantial proportion of these deaths are due to infections (sepsis).     According to the recently formulated Bangladesh National Neonatal Health Strategy (NNHS), the     Government of Bangladesh is committed to improve access to quality management of neonatal     infections. The strategy emphasizes that health service providers at all levels acquire the     skills for managing sepsis.      Responding to the recommendations in the National Neonatal Health Strategy, this operations     research seeks to evaluate alternative approaches for the management of neonatal sepsis in     the community. The evaluation will focus on assessing intervention coverage, provider quality     of care, and referral and referral compliance, and will undertake cost-benefit analysis of     community-based neonatal sepsis management. The programme and evaluation will be within the     existing health service delivery system in Bangladesh and is thus designed to inform the     effective scaling up of neonatal sepsis management and contribute to the implementation of     the NNHS. The interventions to be evaluated will be nested in the Maternal, Neonatal and     Child Survival (MNCS) programme being implemented by the Government of Bangladesh, in     partnership with and supported by UNICEF, and several national NGOs.      This operations research is being implemented by the Government of Bangladesh in     collaboration with UNICEF, SNL - Save the Children (USA), Bangladesh Perinatal Society, and     ICDDR,B. It will take place in four MNCS programme upazilas, where 10 unions will be randomly     selected for intervention and 10 unions will be comparison. The intervention consists of     training of community health workers, village doctors and health facility workers on managing     neonatal sepsis in addition to essential newborn care training. In the comparison areas the     health workers will only receive essential newborn care training.      The intervention and evaluation will continue for at least 18 months, with rolling surveys     and two special surveys at 6 and 12 months into the project. The rolling surveys will look at     intervention coverage, care-seeking, and referral and referral compliance, while the two     special surveys will assess provider performance, referral compliance, and quality of care.     In addition, the investigators will document implementation processes to understand what     worked and what did not and why.   "
148987|NCT01333969|"     The application of a tourniquet for 5 minutes and subsequent reperfusion before actual     inflation of the tourniquet for total knee arthroplasty (ischemic preconditioning) decreases     the level of local inflammation and therefore postoperative pain in response to reperfusion     of the ischemic extremity.   "
148988|NCT01333956|"     Total knee arthroplasty can cause severe postoperative pain, and patients typically receive     oral opioid analgesics for over 2 weeks. Side effects of pain management may impair     participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems     that pregabalin is very helpful to patients after total knee arthroplasty. However,     pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low doses     may not be effective, but use of high doses may increase the incidence and severity of side     effects.The purpose of this study is to determine which dosage of pregabalin is the most     effective at reducing pain after knee surgery.   "
148989|NCT01333943|"     Currently, the regional anesthetic standard of care for total knee replacement surgery is     combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting     approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which     is the major nerve controlling the knee joint. The femoral nerve also provides movement and     sensation. While this regional anesthetic technique offers significant postoperative pain     relief, it is possible that it may cause muscle weakness and increase patients' recovery     time. Hence there is a need for an alternative technique, one that may help minimize     postoperative pain as effectively as the FNB, while not causing weakness of the quadriceps     muscle.      The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it     is hypothesized that by blocking or anesthetizing the saphenous nerve with local anesthetic     closer to where it branches off, the area around and below the knee will feel numb. Yet     unlike with the FNB, the quadriceps muscle itself will still be able to function.      Patients will be randomized to receive FNB or saphenous nerve block. Quadriceps strength will     be tested using a dynamometer before surgery (baseline), 6-8 hours following anesthesia     administration, and on postoperative days 1 and 2. It is hypothesized that patients who     receive FNB will experience a 50% decrease in quadriceps strength compared to baseline.   "
149243|NCT01330628|"     The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with     balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee     peripheral artery in-stent restenosis.   "
148990|NCT01333930|"     The aims of this study are:        -  Characterisation of immunological effects of Active O2 vs. placebo after ingestion          during and post standardised strenuous exercise        -  Characterisation of safety and tolerability of Active O2 in comparison with placebo          after ingestion during and post standardised strenuous exercise considering Adverse          Events observed in the study      Moreover, the suitability of the study design shall be investigated by means of the internal     pilot part, i.e. concerning applied procedures, selected pharmacodynamic parameters and blood     sampling scheme.   "
149130|NCT01332110|"     Patellofemoral pain syndrome (PFPS) is the most common running injury and is believed to be     associated with higher than normal knee joint loading. Footwear has been developed that may     decrease these knee loads in healthy subjects, but their effects on patients with PFPS are     unknown. In this study, we aim to test the effects of such footwear on patients with PFPS. We     hypothesize that patients who receive the footwear intervention will show a decrease in knee     joint loading, and consequently will show improvements in subjective levels of perceived knee     pain over a period of six weeks compared to a control condition.   "
148991|NCT01333917|"     Colorectal cancer is a major problem in the United States and other developed countries. A     safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia.     Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of     years as a traditional remedy. Curcumin blocks a number of targets involved in tumor     initiation, promotion, and progression, and is considered a promising chemopreventive agent.     The investigators propose to enroll 40 patients after screening colonoscopy who will have     rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators     will use microarray analysis to identify genes that are modified by curcumin that could be     used as biomarkers in future chemoprevention studies. The study will also evaluate     tolerability and toxicity.   "
148992|NCT01333904|"     The purpose of this study is to establish single and multiple dose safety in healthy subjects     and subjects with mild chronic pulmonary obstructive disease (COPD). In addition, the study     will evaluate preliminary proof of concept endpoints in COPD subjects such as biomarkers in     sputum and mucociliary clearance.   "
148993|NCT01333891|"     Age-related macular degeneration (AMD) and glaucoma are among the leading causes of blindness     in the western world. Elevated intraocular pressure (IOP) is a well known major risk factor     for glaucoma. In addition, there is growing evidence that vascular factors, including     arterial hypertension and hypotension, may play a role in the pathogenesis of AMD and     glaucoma. To gain more insight into these mechanisms in humans is the primary goal of the     present study.      Optical coherence tomography (OCT) delivers three dimensional, volumetric reflectivity     information through transparent media in vivo. Moreover, the images show a high choroidal     penetration and a resolution comparable to an histologic examination when infrared light     sources are used. Because of its non-invasive character, OCT provides an ideal method for     diagnosis and monitoring of retinal and choroidal abnormalities.      The present study aims to investigate whether choroidal thickness is temporarily altered by     changes in IOP or systemic hemodynamic parameters. IOP will be increased by the use of a     suction cup technique, mean arterial blood pressure will be altered by intravenously     administered Phenylephrine or Sodium-Nitroprusside.   "
148994|NCT01333878|"     The hypothesis of this study is that subcutaneous Abatacept is effective in reducing synovial     inflammation, osteitis, and erosions in Rheumatoid Arthritis as assessed by low field     extremity MRI and X-ray.   "
148995|NCT01333865|"     The main objective of this study is to evaluate the safety and effectiveness of memantine     (Namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism     spectrum disorders (ASD). This is an exploratory, 12-week, pilot study, seeking to determine     whether Namenda is efficacious and well tolerated in the treatment of adults with ASD. The     study results will be used to generate hypotheses for a larger randomized controlled clinical     trial with explicit hypotheses and sufficient statistical power.   "
148996|NCT01333852|"     Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized     phase II trial   "
148997|NCT01333839|"     In this study, the investigators want to examine the impact of coronary artery bypass graft     (CABG) surgery on skeletal muscle mass, muscle metabolism, and insulin sensitivity in 90     subjects. In extent, the impact of a subsequent exercise intervention will be examined, with     a follow-up up to 12 months after surgery.   "
148998|NCT01333826|"     This study is designed to evaluate a two-year randomized intervention in Malawi that provides     cash transfers to current schoolgirls (and young women who have recently dropped out of     school) to stay in (and return to) school in order to understand the possible effects of such     programs on the sexual behavior of the beneficiaries and their subsequent HIV risk.   "
148999|NCT01333813|"     This study will evaluate the persistence of immunity to hepatitis B in healthy children aged     7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life,     and also their ability to mount an immune response to the challenge dose of Engerix-B™     Kinder.   "
149000|NCT01333800|"     The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and     Beclomethasone in pediatric asthma control.   "
149001|NCT01333787|"     The purpose this study was to to evaluate the therapeutic effect of a fibers mixture in the     treatment of chronic constipation and on the colonic transit time in children.   "
149002|NCT01333774|"     It has been recently suggested, that not the diet by itself, but also patient's adherence to     dietary recommendations and all actions performed to improve dietary compliance, may be a     significant factor influencing blood glucose control. There are no clinical data on the     influence of different approaches to dietary advising on the effects of acarbose treatment in     obese diabetic patients under real-life setting in Poland. Thus, the aim of this study was to     assess the influence of different approaches to dietary advisory on the effects of acarbose     treatment (reflected by changes in HbA1c) in obese DM patients. We also intended to assess     the influence of different approaches to dietary advising on the appearance of potential     adverse events in acarbose treated obese DM patients.   "
149003|NCT01333761|"     The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green     (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the     presence of right to left cardiac shunt (RTLS). The CARDIOX system will be compared against     transesophageal echocardiography (TEE) for sensitivity and specificity, as well as     transcranial doppler (TCD) for positive percent agreement and negative percent agreement.   "
149004|NCT01333748|"     The purpose of this study is to determine proportion of patients presented a search allelic     imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or     ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes   "
149005|NCT01333735|"     The aim of the study is to investigate the impact of adjuvant chemotherapy on cognitive     function in patients aged over 65 and suffering from breast cancer or colon.   "
149131|NCT01332097|"     This study will assess preliminary parameters of safety and efficacy of a single dose of     BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.   "
149190|NCT01331330|"     To evaluate the effects of two different programming settings of deep brain stimulation (DBS)     in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for TR-MDD,     single or recurrent episode on mood as measured by the MADRS.   "
149011|NCT01333657|"     Triggering receptor expressed on myeloid cells-1 is a member of the immunoglobulin     superfamily of receptors that is specifically expressed on the surfaces of monocytes and     neutrophils.TREM-1 expression is increased in infectious diseases and is associated with the     release of soluble TREM-1 (sTREM-1).There has been demonstrated that the value of plasma     sTREM-1 levels as an indicator of sepsis was superior, although other studies reported that     the value of sTREM-1 for diagnosing sepsis was inferior.An increasing number of studies     indicate that there are increased levels of sTREM-1 in body fluid samples for the following     diseases and conditions: sepsis, pneumonia, pleural effusion, septic arthritis, meningitis,     peritonitis, and uterine cavity infection.      Inflammation is now believed to play a major role in the pathophysiology of AKI. It is     hypothesized that the initial insult results in morphological and/or functional changes in     vascular endothelial cells and/or in tubular epithelium in sepsis models. Then, leukocytes     including neutrophils, macrophages, natural killer cells, and lymphocytes infiltrate into the     injured kidneys and induce the generation of inflammatory mediators. Whether urine sTREM-1     could also be detected and its significance in sepsis and AKI has not been reported yet.      The present study focused on the value of serum & urine sTREM-1 for sepsis identification,     severity and prognosis assessments, and potential sepsis-related AKI. We also made     comparisons between sTREM-1 and WBC counts, serum CRP, serum PCT, urine output,CC SCr, and     BUN among sepsis patients.   "
149012|NCT01333644|"     It is the central hypothesis of the investigators study that HIV disease is a     pro-inflammatory condition, and that years of inflammation result in premature aging' of the     immune system (immunosenescence). Just as these changes are thought be causally associated     with heart disease in the very old,the investigators postulate that these changes will be     associated with early heart disease in the untreated and perhaps treated HIV disease. To     address this hypothesis, the investigators will measure immunosenescence in a large cohort of     patients who span the entire disease process.   "
149013|NCT01333631|"     This is non-randomized phase 2 study to evaluate toxicity and efficacy of valproic acid (VA)     with concurrent chemoradiotherapy (CCRT) containing weekly gemcitabine in patients with     unresectable locally advanced pancreatic cancer (ULAPC). All patients will be planned for     three-dimensional conformal radiotherapy (3-DCRT). A total dose of 54 Gy will be delivered     using 2 Gy daily fractions given over 5 days a week.Intravenous (i.v.) chemotherapy (ChT)     with gemcitabine 300 mg/m2 will be started at the first day of 3-DCRT.Total 5-6 weekly doses     of i.v. ChT will be planned.VA will be administered orally in daily dose of 800 mg. Treatment     with VA will be commenced at the first day and will be terminated at last day of RT.The     patients will be followed till disease progression or death.   "
149014|NCT01333618|"     It has been demonstrated that implantation of inferior vena cava filter was safe and     effective in the prevention or reduction of fatal pulmonary thromboembolism in numerous     clinical researches. When acute deep venous thrombosis need transcatheter thrombolysis,     transfemoral Günther Tulip Filter implantation could avoid catheter across the Günther Tulip     Filter. Although incidence of significant filter tilting (>10°) is not high (13%-16%), severe     tilting of the Günther Tulip Filter may be associated with difficulty or sometimes     impossibility of retrieval. It has been reported that a simple technique of keeping tension     of the delivery system may prevent significant tilting of the transjugular Günther Tulip     Filter in an in-vitro study. But no clinical study of prevention transfemoral Günther Tulip     Filter from tilting has been reported. The investigators conducted a randomized, controlled     study to test whether the introducer curving technique is useful to decrease the extent of     tilting of transfemoral Günther Tulip Filter.   "
149015|NCT01333605|"     The aim of study is to prove IGEV regimen followed by autologous stem cell transplantation as     salvage treatment in patients with refractory or relapsed Hodgkin lymphoma is effective.   "
149016|NCT01333592|"     The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as     combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show     inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.   "
149017|NCT01333579|"     Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the unaffected     hemisphere (UH) transiently improves motor function in patients in the chronic phase after     stroke. The goal of this study is to investigate effects on motor recovery of low-frequency     rTMS of the UH, administered in the subacute phase after stroke.   "
149018|NCT01333566|"     The long-term goal of our research program is to develop an effective and cost-saving     mind-body therapy to help patients with FM. The objective of this pilot study is to gather     pilot data of the effect on pain, fatigue, sleep quality, and quality of life in FM patients     using a specific type of qigong exercise, i.e. six healing sound qigong. Changes in     relevant brain activity will be monitored in study subjects before and after the qigong     exercise program, which may help us in better understanding the underlying mechanism of the     qigong exercise. Data collected in this pilot study will help the investigators in     preparation for a future clinical trial with a larger sample size. Our central hypothesis for     the future clinical trial is that qigong exercise will lead to a significantly greater     improvement in pain, fatigue, sleep quality, and quality of life in the experimental group     compared to the control group.   "
149019|NCT01333553|"     The researcher develop non-invasive imaging modalities for assessment of port wine stain     during laser therapy treatment of Port Wine Stain. The imaging modalities will be used to     guide immediate retreatment of regions of persistent perfusion during the procedure.   "
149020|NCT01333540|"     A dose-escalation study to assess the safety, tolerability and clinical activity of TD−1211     in patients with opioid-induced constipation.   "
149041|NCT01333267|"     This is a dose escalation study to determine the maximum tolerable dose of Parathyroid     Hormone-related Protein, PTHrP, or Parathyroid Hormone, PTH, that can be given safely over     one week in healthy African-American volunteers. The investigators plan to infuse low doses     of intravenous PTHrP or PTH to determine if it leads to a sustained and progressive     suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an     increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the     investigators will assess the direct influence of PTHrP and PTH on vitamin D metabolism,     markers of bone turnover, and fractional excretion of calcium. These results will be compared     to previous studies of Caucasian volunteers.   "
200676|NCT00468481|"     The purpose of this study is to determine whether the study drug is safe and effective   "
149021|NCT01333527|"     Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is     done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease     pain, and to increase range of motion (ROM) and strength. This is done arthroscopically;     through a small incision in the patient's shoulder. After surgery, patients are usually     placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this     time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or     active shoulder movement is usually not permitted to allow the repaired tendons to heal.     Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can     delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a     slower return-to-work or daily activities, and may also impact the health care system,     through increased use and cost of rehabilitation.      This study's purpose is to determine if patients can safely stop wearing their sling as early     as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will     be randomly assigned to one of two study groups:      Patients in Group A (accelerated rehab) will wear their sling for comfort only following     surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may     stop wearing their sling if pain and comfort allow, and start active movement for activities     of daily living only.      Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A,     self-assisted ROM exercises are allowed at any time, but active movement will not be allowed     until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM     exercises after surgery.      Patients who agree to participate in the study will see their surgeon and the study physical     therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months     post-surgery). Each visit will take about 30 minutes and will include a ROM assessment,     strength assessment (as appropriate) and disease-specific quality of life questionnaires.     Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at     12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse     events will be examined between the two groups. Differences will also be examined according     to RC tear size and patient characteristics.   "
149022|NCT01333514|"     Good sugar control in postoperative hospitalized patient has been shown to improve wound     healing and infection rates. However, sugar control is difficult to achieve and suboptimal     use of insulin is thought to be a contributory factor. Though it is known that generally the     consumption of carbohydrates alone raises the blood sugar, the usual practice of dosing     meal-time insulin is based on the fraction of the total meal-tray eaten which includes     proteins, fats and carbohydrates. This leads to an overestimation of insulin required for a     patient who consumes a portion of mainly proteins and fats on their trays or an     underestimation for those eating mainly the carbohydrates on their tray. Low sugars or high     blood sugars can follow respectively.      Hypothesis: The purpose of this study is to see if dosing meal-time insulin based on grams of     carbohydrates consumed will result in better sugar control compared to the usual practice of     dosing meal-time insulin based on percent of total meal consumed in hospitalized patients.   "
149023|NCT01333501|"     The purpose of this pilot study is to evaluate, by means of a specific cognitive test battery     (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the     slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of     treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate     which test of the battery is the most sensitive in detecting differences between treatment     groups.   "
149024|NCT01333488|"     The investigators hypothesize that hypothermia (body cooling) and additional magnesium     sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients.      This is a study to compare the outcomes of patients with severe traumatic brain injury who     have been allocated to one of the following three groups:      Group 1 - Conventional therapy following traumatic brain injury Group 2 - Subjects will have     their core body temperature lowered to 34C Group 3 - Subjects will have their core body     temperature lowered to 34C and will receive a supplemental intravenous infusion of magnesium     sulfate.   "
149025|NCT01333475|"     Background:      - MK-2206 and AZD6244 (Selumetinib) are experimental cancer treatment drugs that block the     effect of certain proteins that cancer cells need to grow and survive. These drugs may be     effective treatments for some types of colorectal cancer that has not responded to or has     relapsed after standard treatment. Researchers are interested in studying how MK-2206 and     AZD6244 affect levels of certain proteins in colorectal cancer tumor, and how well the drugs     work against cancer cells by examining cells from a tumor sample collected before the drugs     are given and again after the drugs are given.      Objectives:      - To evaluate the safety and effectiveness of MK-2206 and AZD6244 in individuals with     advanced colorectal carcinoma that has not responded to standard treatments.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with advanced colorectal     carcinoma that has not responded to at least one type of standard chemotherapy.      Design:        -  Participants will be screened with a physical examination, medical history, blood tests,          and tumor imaging studies.        -  Participants will take MK-2206 and AZD6244 by mouth for 4-week cycles of treatment, with          one dose of MK-2206 per week and one dose of AZD6244 every day. (If participants have          negative side effects from the medications, the doses will be adjusted to a smaller          dose). Participants will keep a diary to record doses and keep track of any side          effects.        -  During treatment, participants will have regular visits to the clinical center,          involving blood and urine tests, tumor biopsies, and other examinations to monitor the          effects of treatment. Participants will have imaging studies every two cycles (8 weeks)          to study the cancer's response to the treatment.        -  Participants will continue to have cycles of treatment for as long as the treatment          continues to be effective and the side effects are not severe enough to stop          participation in the study....   "
149026|NCT01333462|"     The purpose of this study is to test the safety and immune response of a new intranasal     vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine that     is normally given as an injection, called Fluzone, and an adjuvant (additive that helps a     vaccine work better), called W805EC.   "
149027|NCT01333449|"     Allogeneic blood stem cell transplant remains the only potential curative treatment for     myelodysplastic syndromes (MDS) to date. Pre-transplant induction chemotherapy with     leukemia-type regimens is associated with significant toxicity and even death. The     hypomethylating agents decitabine and 5-azacytidine have been shown in studies to cause     improved hematologic parameters and partial or complete responses in patients with high risk     MDS compared to standard therapy. In contrast to leukemia-type chemotherapy, decitabine is     associated with a relatively low risk of toxicity. We therefore propose to treat     transplant-eligible MDS patients with Decitabine as induction therapy and a bridge to     transplant.      Hypothesis:        1. Decitabine is able to reduce disease burden as measured by blood and marrow blast counts          prior to allogeneic hematopoietic stem cell transplant to below 5%.        2. Decitabine is well-tolerated by patients with high-risk MDS and will be a safe induction          agent and bridge prior to allogeneic transplant in transplant-eligible patients.   "
149028|NCT01333436|"     This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in     diabetic participants compared to nondiabetic participants with the same range of serum LDL-C     levels, and whether ApoB-48 levels can be used, along with LDL-C levels, to identify     potential cardiovascular disease risk.   "
149029|NCT01333423|"     The goal of this clinical research study is to find the highest tolerable dose of seliciclib     that can be given in combination with liposomal doxorubicin to patients with metastatic     breast cancer.   "
149057|NCT01333059|"     The purpose of this study is to determine if the reduction of the total amount of sedative     critically pediatric ill patients receive in the PICU will achieve a significant decrease in     mechanical ventilation days and a decrease in the overall length of stay in the PICU and     hospital.   "
155287|NCT01251289|"     A retrospective review of the prevalence of Group B Streptococcus Positive Pregnant Patients     in an Inner City Tertiary Care Center   "
149030|NCT01333410|"     Vitiligo has remained a difficult disease to treat. Previous available therapies are often     ineffective. It usually takes several months or years for complete repigmentation and some     areas of the body get at best only partial repigmentation. The desire of the patient to     undergo therapy varies from patient to patient and needs to be assessed individually. Several     factors should be considered when planning the treatment strategies including type of     vitiligo, site and degree of involvement, skin color, psychological effect, patient     compliance, ease to assess to therapy, cost of treatment and social association of the     disease.      Topical corticosteroids are still be the standard treatment of localized vitiligo. However,     the adverse effects such as skin atrophy, striae, pigmentary change and     hypothalamic-pituitary adrenal axis suppression can occur if we use inappropriate strength of     topical steroids for a long period of time.      Tacrolimus (FK-506) is a new immunosuppressive agent that acts by inhibiting T-cell     activation and cytokine release. It offers a safe and efficacious alternative for many skin     conditions. It minimizes the need for topical glucocorticoids and does not cause skin     atrophy. Tacrolimus was first reported for treatment of vitiligo in 2002. The underlying     mechanism was shown in an in vitro study that topical tacrolimus promoted proliferation of     melanocytes and melanoblasts.      This study purpose is to evaluate the efficacy and safety of 0.1% topical tacrolimus ointment     comparing to 0.1% mometasone furoate cream in the treatment of adult vitiligo.   "
149031|NCT01333397|"     The primary objective is to assess the dose response versus placebo of a single treatment of     Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of     moderate to severe glabellar lines at maximum frown.   "
149032|NCT01333384|"     The purpose of this study is to evaluate over the 24 month prospective follow up - in     everyday clinical practice - resource utilization and effectiveness of the treatment of     acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection     intervals.   "
149033|NCT01333371|"     Patients will be randomized to volar plating with early ROM versus closed reduction with     K-wires and 6 weeks of cast immobilization to determine if there is any advantage to volar     plating in this subgroup of patients with distal radius fractures.   "
149034|NCT01333358|"     The main purpose of this research study is to investigate how well a medicine (alemtuzumab)     works in treating MS-related cognitive problems (e.g., attention, memory, speed of thinking).     This study will include 30 subjects from six research sites.      Alemtuzumab is approved and sold under the brand names Campath and MabCampath to treat some     types of leukemia. As a leukemia treatment, it is given more often and at much higher doses     than in this study.   "
149035|NCT01333345|"     The purpose of this study is to obtain data on the performance of the EC-3 lens at an     interval of two years (and beyond) from subjects who were implanted. The primary aim of the     study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies     in the subjects.   "
149036|NCT01333332|"     The purpose of this study is to determine safety and to obtain preliminary estimates of the     rate of major pathologic response of neoadjuvant accelerated fraction, standard dose     radiation given with chemotherapy in patients with locally advanced pancreas cancer.   "
149037|NCT01333319|"     Renal dysfunction is a major risk factor for poorer outcome after liver transplantation.     Nevertheless, mechanisms of renal dysfunction in liver transplant recipients are not clearly     understood. Calcineurin inhibitors are generally perceived as the most important cause;     however the liver transplant procedure itself represents a major surgical / hemodynamic /     inflammatory trauma that - on its own - can cause renal dysfunction. Creatinine and     creatinine clearance are late markers of acute kidney injury and changes in these parameters     occur only after substantial injury has already occurred. Even a stable creatinine does not     exclude structural kidney damage.      A series of new markers of tissue injury have been identified and have the potential to     identify acute kidney injury better and earlier than creatinine and creatinine clearance. The     aim of this study is to determine whether and how liver transplantation affects these urinary     and plasma biomarkers and to study whether the changes in these biomarkers may predict later     changes in standard functional parameters (creatinine and creatinine clearance). For this     purpose, the urinary and plasma biomarkers, together with creatinine, will be determined     serially during the different phases of the liver transplant process and daily until day 5     after transplantation.   "
149038|NCT01333306|"     Cognitive rehabilitation involves enhancing an individual's capacity to process information     to improve their everyday functioning. One common form of intervention is computerised     cognitive training (CT); however, efficacy results have been mixed. This research aims to     investigate a novel method for enhancing outcomes from CT through combining CT with     transcranial direct current stimulation (tDCS), a non-invasive and painless form of brain     stimulation. In this study we aim to determine the efficacy of this approach through     comparing in a randomized controlled study tDCS combined with CT versus CT and tDCS alone in     healthy participants. We hypothesise that tDCS combined with CT will have greater     generalisability effects than the other conditions.   "
149039|NCT01333293|"     Patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo,     fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by     mast cells. These patients have also an increased frequency of anaphylactic/anaphylactoid     reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast media,     local anesthetics or analgesics. In addition, there is increased osteoporosis in mastocytosis     patients due to the activity of mast cell mediators on osteoblasts and osteoclasts. Symptoms     of mastocytosis respond poorly to treatment with antihistamines or other antiallergic drugs.     There is currently no specific treatment for this disease with the exception of rare cases.     There are, however, some case reports suggesting that omalizumab might decrease symptoms     including hypotensive events.      The aim of the study is to investigate whether patients suffering from mastocytosis benefit     from a 6 month course of omalizumab with regard to symptoms and quality of life and whether     the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the     efficacy of omalizumab in patients with mastocytosis.        -  Trial with medicinal product   "
149040|NCT01333280|"     The purpose of the study is to determine whether adding dual focus mutual aid groups to     formal treatment for people dually diagnosed with substance abuse and mental illness is     effective in improving treatment outcomes.      NO VOLUNTEERS ARE ACCEPTED. ENROLLMENT IS LIMITED TO CLIENTS OF THE PARTICIPATING TREATMENT     PROGRAMS.   "
149043|NCT01333241|"     The overall goal of this randomized controlled trial is to evaluate the effects of a     community-based lifestyle behavior intervention (LSBI) that is designed to improve diet,     reduce weight and increase physical activity (PA) of Latino women who are predominantly     Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas     participating in a LSBI conducted by promotoras will demonstrate a greater decrease in BMI     and a higher increase in physical activity than those in a control condition, Women in the     LSBI also are expected to demonstrate improvements in selected physiologic outcomes (blood     pressure [BP], measures of cholesterol and blood sugar, waist circumference), and     self-reported lifestyle behaviors (diet, PA). of these participants are also e   "
149044|NCT01333228|"     Endothelial Progenitor Cells (EPC) represent a small cellular population of bone marrow and     peripheral blood cells. EPCs are recruited into injured tissues and play an important role in     regeneration and reparation. Experimental and clinical data suggest that EPCs have     hepatoprotective activity and could improve liver regeneration during acute and chronic liver     injury. The aim of this project is to evaluate the safety and therapeutic effects of     autologous bone marrow-derived EPCs, when administered through the hepatic artery of patients     with advanced liver cirrhosis.   "
149045|NCT01333215|"     The purpose of this study is to compare the cognitive inhibition deficit among depressed     older suicide attempters compared to depressed older suicide non-attempters.   "
149046|NCT01333202|"     The purpose of this study is to determine whether fresh lime alone is effective for smoking     cessation.   "
149047|NCT01333189|"     The purpose of this study is to determine if rehabilitation using weight-bearing biofeedback     training following total knee arthroplasty (TKA) is more effective than standard     rehabilitation methods in promoting weight-bearing symmetry through the lower limbs during     functional activities such as sit-to-stand transfers and walking. Secondary outcomes of     interest include functional measures and internal moment at the hip, knee, and ankle joints     during sit-to-stand and walking.   "
149048|NCT01333176|"     1. Purpose             -  to estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in a               BC First Nation community             -  to determine the utility of community based screening by examining how many               positively screened people follow up with the recommended subsequent testing and               family physician visit             -  to determine if point-of-care HbA1c test (Ames/Bayer DCA 2000) correlates with the               confirmatory fasting and 2 hour post challenge blood glucose tests.        2. Hypothesis The Point-of-Care test will correlate well with the gold standard diagnostic          tests and prove to be a useful tool for community-based screening. This test obviates          the need for fasting and repeat glucose tolerance testing.   "
149049|NCT01333163|"     The purpose of this study is to investigate how Glucagon-Like Peptide 1 (GLP-1) affects     kidney function in healthy young men. The hypothesis is that GLP-1 induces a positive effect     on kidney hemodynamics.   "
149050|NCT01333150|"     The project's primary purpose is to test the hypothesis that oral administration of a low     single dose of β-antagonist propranolol (40 mg) reduces pain sensitivity in patients with     masticatory muscle pain.   "
149051|NCT01333137|"     P276-00 is a novel, potent, small-molecule, flavone-derived Cdk 4 D1, Cdk1 B, and Cdk9 T     inhibitor, with potent cytotoxic effects against chemosensitive and chemoresistant cancer     cell lines.This study is planned to compare efficacy of the standard chemotherapy regimen of     gemcitabine and carboplatin when administered with or without P276-00 in subjects with     advanced triple negative breast cancer.   "
149052|NCT01333124|"     This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with     gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.   "
149053|NCT01333111|"     This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this     trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which     the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for     treatment and prophylaxis of bleeding episodes in patients with haemophilia B.   "
149054|NCT01333098|"     This study seeks to develop and test a novel, mechanistic treatment for mitigating cognitive     impairment in older adults with anxiety disorders. Anxiety disorders are common, severe, and     disabling in older adults. One particularly impairing aspect of late-life anxiety disorders     is cognitive impairment: impairments in memory and executive function cause disability,     impede treatment response to psychotherapy, may lead to dementia, and are not corrected by     standard anti-anxiety treatments.      This pilot study will test the glucocorticoid antagonist, mifepristone, for cognitive     impairment in late-life anxiety disorders. Mifepristone blocks the effects of elevated     cortisol levels on glucocorticoid receptors in the brain; it has been studied preliminarily     in various neuropsychiatric disorders, such as psychotic depression and bipolar disorder,     with well-documented safety and tolerability.   "
149055|NCT01333085|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving     everolimus together with carboplatin and paclitaxel in treating patients with locally     advanced head and neck cancer that cannot be removed by surgery.   "
149056|NCT01333072|"     The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will     provide evidence-based guidance in the selection and monitoring of drug treatment of autism.     BAART involves 3 academic centers across South Carolina. Although the FDA has approved use of     the antipsychotic drug risperidone for irritability associated with autistic disorder, a     moderate response rate in pivotal clinical trials and concerns over tolerability and weight     gain can force clinicians to select alternative drug treatments for which evidence-based     support is sparse.   "
149132|NCT01332084|"     The investigators plan to launch a Specific Oral Tolerance Induction (SOTI) pilot study in     order to assess the efficacy and the safety of hypoallergenic (H.A.) wheat cereals, for     children with allergy to wheat. The study has the potential to offer a desensitization     treatment option for children allergic to wheat.      The investigators hypothesize that H.A. wheat cereals have similar efficacy with less side     effects than native wheat cereals.   "
149058|NCT01333046|"     Patients have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has     come back, or may come back, or has not gone away after treatment, including the standard     treatment known for these diseases. This a research study using special immune system cells     called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental     therapy.      This sort of therapy has been used previously to treat Hodgkin or non-Hodgkin lymphomas that     show proof of infection with Epstein-Barr virus (EBV), the virus that causes infectious     mononucleosis (mono or the kissing disease). EBV is found in cancer cells of up to half     of all patients with Hodgkin's and non-Hodgkin lymphoma. This suggests that it may play a     role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's     immune system and escape being killed. Investigators tested whether special white blood     cells, called T cells, that were trained to kill EBV-infected cells could affect these     tumors, and in many patients it was found that giving these trained T cells caused a complete     or partial response.      However, many patients do not have EBV in their lymphoma cells; therefore investigators now     want to test whether it is possible to direct these special T cells against other types of     proteins on the tumor cell surface with similar promising results. The proteins that will be     targeted in this study are called tumor associated antigens (TAAs) - these are cell proteins     that are specific to the cancer cell, so they either do not show or show up in low quantities     on normal human cells.      In this study, we will target five TAAs which commonly show on lymphoma, called: NY-ESO-1,     MAGEA4, PRAME, Survivin and SSX. This will be done by using special types of T cells called     cytotoxic T lymphocytes (CTLs) generated in the lab.      In addition, some adult patients will receive a drug called 5-azacytidine before giving the T     cells. We hope that the combination helps the T cells work better.   "
149059|NCT01333033|"     RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to     treatment and help plan the best treatment.      PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response in     patients with esophageal cancer receiving combination chemotherapy.   "
149060|NCT01333020|"     This comparative pilot study is designed to compare the rates of gastric emptying and by     inference rates of digestion of two food emulsions. Two types of milk protein stabilised food     emulsion will be compared, one standard emulsion preparation and one emulsion preparation     cross-linked with microbial transglutaminase. The information from this study will then be     compared to data on satiety and endocrine hormones from a parallel study undertaken in     Finland using the same two meal formulations. The drinks will be labeled with a stable     isotope of carbon and samples of breath collected every 20 minutes after consumption of the     drink. This will allow gastric residence time to be calculated. The pilot will also fulfill     two secondary objectives. At the same time as the breath samples are collected MRI scans of     the upper abdomen will be made so that gastric volumes can be measured in order to compare     the two methods of measuring gastric emptying rates. Additionally, samples of saliva will     also be collected after every MRI scan for subsequent mass spectrometry analysis. These are     to assess the efficacy of mass spectrometry analysis for detection of the presence of     specific digestion related hormones such as ghrelin.   "
149061|NCT01333007|"     This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab)     as first-line treatment in combination with chemotherapy in patients with inoperable     advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical     practice. Data will be collected for each patient for 18 months from initiation of Avastin     therapy.   "
149062|NCT01332994|"     This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate     the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid     arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12     weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate     clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g     MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study     treatment is 32 weeks.   "
149063|NCT01332981|"     This is an observational follow-up study on the efficacy of 1st-line treatment with Herceptin     (trastuzumab) in patients with metastatic breast cancer 7 years after initiation of     treatment.   "
149064|NCT01332968|"     This open-label, randomized study will assess the efficacy and safety of obinutuzumab     (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with     chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated     advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants     achieving response (Complete response [CR] or partial response [PR]) will undergo a     maintenance period continuing on the randomized antibody treatment alone every 2 months until     disease progression for a total of 2 years. Anticipated time on study treatment is up to     approximately 2.5 years. After maintenance or observation, participants will be followed for     5 years until progression. After progression, participants will be followed for new     anti-lymphoma therapy and overall survival until the end of the study.   "
149065|NCT01332955|"     This phase II, multicentric, national pilot trial is designed to estimate the sustained     virological response rate (SVR) following a 12 weeks treatment by telaprevir combined with a     48 or 72 weeks treatment by peginterferon and ribavirin, based upon the rapid virological     response (RVR) at week 8 (4 weeks after telaprevir start), and to compare the observed SVR to     20%, a rate determining a significant therapeutic benefit in this population of patients. The     primary endpoint will be the SVR defined as undetectable HCV-RNA measured 24 weeks after the     end of therapy (EOT).   "
149066|NCT01332942|"     The drug that is under investigation during this study is BAY85-3934 which is intended to be     used as a treatment for patients suffering from renal anemia due to chronic kidney disease     (stage 3 and 4).      The purpose of this study is to provide safety and tolerability information on the drug.     Other objectives of the study are to investigate the effect of the drug on the body     (pharmacodynamics) as well as the absorption, breakdown, metabolism, distribution and     excretion (pharmacokinetics) by measuring the concentration in blood and urine.      The study will be conducted in one study center in the United Kingdom and several centers in     Germany. 84 (of which 36 are optional) patients who meet the inclusion criteria will     participate in the study. BAY 85-3934 will be given following a combined single / multiple     dose escalation design in seven (of which three are optional) dose steps.   "
149083|NCT01332721|"     The purpose of the study is to evaluate safety and tolerability and determine a recommended     Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced     solid tumors for which bevacizumab is indicated.   "
149084|NCT01332708|"     The investigators aims in the current study are to examine whether the cholinergic status     should be considered as another risk factor for the metabolic syndrome and it's     co-morbidities and to test the effect of a hypocaloric high complex carbohydrates diet on the     cholinergic status of overweight and obese adults with and without the metabolic syndrome.   "
157522|NCT01221818|"     The purpose of this study is to evaluate the safety and tolerability of single oral ascending     doses of E6007 in healthy subjects.   "
149067|NCT01332929|"     This phase I pilot study aims to define the safety of a combined treatment of bevacizumab and     whole brain radiation therapy for the treatment of patients with brain metastasis of solid     tumors. If this therapeutic scheme confirms it's safety profile, the investigators can     expect:        -  first, to allow that all patients can receive bevacizumab for their advanced and/or          metastatic cancer if necessary, even in case of brain metastasis.        -  Secondly, if this trial confirm a synergic effect of the combination of angiogenesis          inhibitors and brain radiotherapy for local control of brain metastasis, an improvement          of the therapeutic results for these patients which have a poor hope of survival and for          which none innovative approach is currently suggested.      Moreover, the investigators hope that the analysis of the different data of MRI evaluation -     morphological and functional - will allow better definition of radiological evaluation of the     therapeutic effect of angiogenesis inhibitors on brain metastasis.   "
149068|NCT01332916|"     The purpose of this study is to investigate memory problems in patients with cancer.   "
149069|NCT01332903|"     This is a phase I, open label, healthy volunteers, ADME study with single oral administration     of [14C] AZD5069.   "
149070|NCT01332890|"     To evaluate drug-drug interaction   "
149071|NCT01332877|"     EFFECT OF HIGH CARBOHYDRATE AND HIGH PROTEIN BREAKFAST ON WEIGHT LOSS, GHRELIN, HUNGER AND     CRAVING SCORES IN OBESE MEN AND WOMEN. D Jakubowicz, M Boaz, J Wainstein, O Froy      Background: Obesity underlying endocrine, metabolic and eating behaviour features promotes     weight gain, increase of hunger, and carbohydrate (Carb) craving. Restrictive diets either in     calories or Carb produce withdrawal effect, that further exacerbate Carb craving resulting in     rapid return of obesity. Meal timing and composition has shown to play a pivotal role in     appetite regulation through several hormonal systems such as ghrelin. The investigators     hypothesized that to be successful; a weight loss strategy must change the hormonal     environment to increase satiety while reducing hunger and craving.      Objectives: To assess weight loss, satiety, hunger, cravings and ghrelin response to two     isocaloric diets. Additionally, these outcomes were measured in response to meal challenge.      Methods: In this randomized, treatment controlled clinical trial, 146 obese, sedentary adults     with impaired glucose tolerance will be assigned to Low carb diet (LCHbd) or an isocaloric     diet with a high carb, high protein breakfast (HCPbd),1400 kcal for women and 1600 kcal for     men. LCHbd breakfast will provide 300 kcal with carb: protein: fat of 13:40:48. HCPbd     breakfast will provide 600 kcal with 50:20:30. From baseline until week 16 participants will     take part in a supervised weight loss diet, followed until week 32 by a maintenance period.     Anthropometric measures, OGTT for glucose and insulin, VAS-measured hunger and satiety and     Food Craving Inventory Analysis will be performed at baseline, week 16 and week 32.   "
149072|NCT01332864|"     Participants with chronic or recurrent headache, unrelated to any known pathology or disease,     will be randomly assigned to one of four interventions: Osteopathic manipulation of the body     other than the head, osteopathic manipulation of the head, osteopathic manipulation of the     head and rest of the body, or light touch on the head only but no manipulation. Measurements     of heart rate and blood pressure variability, peripheral blood flow, and behavioral changes,     such as mood, pain duration, intensity and frequency will be assessed.   "
149073|NCT01332851|"     The study evaluates the feasibility and effectiveness of a well-documented relationship-based     intervention (Promoting First Relationships), compared to a resource and referral condition,     in improving outcomes for families of infants and toddlers referred to Child Protective     Services (CPS) for maltreatment. In addition, it evaluates the effectiveness of training     community social service workers in providing the intervention.   "
149074|NCT01332838|"     The purpose of this study is to determine if the use of specialized compression garments, in     comparison to standard compression, improves early patient outcomes after endovenous     ablation.   "
149075|NCT01332825|"     The purpose of this study is to determine the normal distribution of nasal tissue     cathelicidin antimicrobial peptides (cAMP) levels in subjects with normal smell and subjects     with smell dysfunction. The investigators will also look at the effect of nasal saline     irrigation on olfaction and cAMP levels and if nasal irrigation is capable of harvesting     olfactory cilia. The investigators hypothesize that nasal saline will have no effect on     olfaction and will be inadequate to harvest olfactory cilia.   "
149076|NCT01332812|"     This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive     dysfunction in the postoperative period of elderly patients undergoing to surgery under     general anesthesia.   "
149077|NCT01332799|"     Cardiovascular disease is the leading cause of mortality in kidney transplantation. The     enzyme xanthine oxidase may play an important role in the cardiovascular disease of kidney     transplant recipients. Inhibiting this enzyme with allopurinol may improve vascular health     and protects against cardiovascular complications.   "
149078|NCT01332786|"     The purpose of this study is to determine whether tigecycline is safe and which dosage is     most effective in the treatment of patients with acute myeloid leukemia.   "
149079|NCT01332773|"     To show whether the artery first approach leads to equal or less rate of positive resection     margins in pancreatic head cancer than the standard technique (ppWhipple only with standard     Kocher's manoeuvre)   "
149080|NCT01332760|"     Dentists and dental hygienists experience elevated rates of musculoskeletal disorders, such     as carpal tunnel syndrome and tendonitis, primarily due to the high pinch force required for     dental scaling. There is evidence that a lighter and larger diameter tool can significantly     reduce the pinch force. This randomized controlled study will determine if dentists or dental     hygienists who use such a tool report less hand and arm pain compared to those who continue     to use the conventional tool design.   "
149081|NCT01332747|"     The purpose of this clinical trial is to study the comparative effect of a classical unani     antiobesity drug safoof-e-muhazzil on hyperlipidemia in its classical powder form and in     compressed tablet form against a standard control.   "
149082|NCT01332734|"     During infections (sepsis) bloodflow in small vessels (microcirculation) becomes disturbed.     Restoration of bloodpressure and cardiac performance may not be sufficient to correct these     alterations. Magnesium is a potent vasodilator which may be used to open up the small     vessels, in order to reduce organ failure.   "
152445|NCT01288404|"     Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization     in pterygium, preventing or retarding the progression of recurrence.   "
149087|NCT01332669|"     In unresectable hepatocellular carcinoma, TACE using Lipiodol/anti cancer agent emulsion is     the standard treatment and reported as a significantly better treatment through randomized     comparison study like Llovet, etc. than conservative treatment. Recently, doctors do     transarterial chemoembolization with drug-eluting bead, and it is proved less side effect and     better efficacy than conventional TACE using Lipiodol in Precision V study by Dr. Lammer,     etc. But, it could not defined improved survival rate as expected. This study's purpose is     evaluating treatment efficacy, survival rate and safety of TACE using drug eluting bead by     comparing to conventional TACE using doxorubicin/Lipiodol emulsion for unresectable     hepatocellular carcinoma.   "
149088|NCT01332656|"     Primary Objective:      - To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus     placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with     paclitaxel and carboplatin.      Secondary Objectives:        -  To compare the overall survival (OS) between the 2 treatment arms        -  To compare the objective response rate (RR) between the 2 treatment arms   "
149089|NCT01332643|"     This study evaluates the effect of single embryo transfer (SET) with and without array CGH     for the evaluation of the complete chromosome complement of the blastocyst. Patients will be     allocated at random into two groups. The control group will consist of patients in which one     embryo will be replaced on day 5 based on morphological and developmental characteristics,     and the other embryos reaching blastocyst stage will be vitrified. The test group will     consist of patients undergoing embryo biopsy at the blastocyst stage (day 5 of development,     embryo freezing, and analysis of the biopsied cells with a comprehensive chromosome analysis     technique (array Comparative Genome hybridization or aCGH). Only a chromosomally normal     blastocyst will be replaced in a thawed cycle. Inclusion and exclusion criteria are described     in the study population section.   "
149090|NCT01332630|"     The goal of the first part of this clinical research study is to find the highest tolerable     dose of TPI-287 in patients with breast cancer that has spread to the brain.      The goal of the second part of this study is to learn if TPI-287 can control breast cancer     that has spread to the brain. The safety of this drug will also be studied.   "
149091|NCT01332617|"     The purpose of this study test the hypothesis that the combination of simvastatin and     zoledronic acid (for reversal of drug resistance), with bortezomib, high-dose     methylprednisolone and bendamustine on a day 1,8 schedule (to reduce toxicity) will be an     effective and well-tolerated treatment for relapsed and refractory multiple myeloma   "
149092|NCT01332604|"     This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the     safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with     capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients     with advanced or metastatic solid tumors.   "
149093|NCT01332591|"     The aim of the study is to find the optimal management of patients with acute myocardial     infarction with ST elevations treated by primary PCI who have at least one significant     stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence     of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during     the follow up of 24 months in group of patients treated with staged revascularization (PCI or     CABG) in comparison with patients treated conservatively.   "
149094|NCT01332578|"     The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma     faster than standard paracetamol tablets. The study will also assess the gastrointestinal     transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is     postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a     greater early exposure compared to standard paracetamol tablets. In addition, the     pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.   "
149095|NCT01332565|"     This study is a Phase 1, open label, non-randomized, single dose study to determine     pharmacokinetics, safety and tolerability of doultegravir (DTG) following 50 mg single oral     administration in healthy Japanese subjects. A total of 10 healthy Japanese subjects will be     enrolled in this study to receive a 50 mg single dose of DTG. Subjects will have a screening     visit within 30 days prior to the administration of study drug, a treatment visit, and a     follow-up visit 7-14 days after the administration of study drug.   "
149096|NCT01332552|"     GSK2485852 is a Hepatitis C NS5B site IV non-nucleoside polymerase inhibitor being developed     for the treatment of chronic HCV infection. HBI115040 is the first administration of     GSK2485852 in humans to establish the initial safety, tolerability, pharmacokinetic, and     antiviral profile. The study design is a fusion of single and repeat dosing cohorts in HCV     infected subjects to evaluate the safety, pharmacokinetics, and antiviral activity of     GSK2485852.      HBI115040 describes a Phase I, randomized, double-blind, placebo-controlled, dose escalation     fusion study to determine the safety, tolerability, pharmacokinetic, and antiviral profile of     GSK2485852 in single doses (Part 1), repeat doses (Part 2), and ritonavir co-administration     (Part 3) in chronically infected HCV subjects. The study will also explore the effect of a     moderate (30%) fat meal on pharmacokinetic endpoints in HCV subjects in Part 1.   "
149097|NCT01332539|"     observational, non-interventional study in 120 patients with drug-resistant partial epilepsy,     comprising two phases: a 3-month retrospective and a 6-month prospective. As control group,     120 patients with controlled partial epilepsy will be enrolled. The objective of the study is     to describe the burden of illness in this epileptic population both in terms of costs and of     quality of life. Costs and quality of life will be also compared between the two populations.   "
149106|NCT01332422|"     To investigate possible problems or questions in safety and efficacy of ADOAIR 100 DISKUS and     ADOAIR 50 AEROSOL 120 in Japanese pediatric patients with bronchial asthma for a long term     under the practical use conditions. In this special drug use investigation, the following     items shall be handled as the priority investigation items for information collection.        1. Systemic effects accompanying steroid administration; influences on adrenocortical          function, influences on bone metabolisms (fracture, osteoporosis, etc.), cataract,          glaucoma        2. Events related to nervous system, musculoskeletal system and circulatory system; tremor,          headache, cramp, tachycardia, etc.   "
149244|NCT01330615|"     Aims:      The investigators main purpose is to assess the efficacy of analgesia provide by topical     lidocaine/prilocaine cream 5% (EMLA)® to pared plantar warts prior to application of liquid     nitrogen cryotherapy in adults.   "
149098|NCT01332526|"     Fructose intake from added sugars has increased dramatically over the last century and has     recently been implicated as potential contributor to metabolic syndrome, obesity,     hypertension, inflammation and kidney disease. Fructose differs from the other sugars     because, uric acid is generated during its metabolism. Serum uric acid levels have been found     to correlate with the intake of fructose and added sugars. In turn, an elevated serum uric     acid has also been shown to be associated with increased risk for cardiovascular and     metabolic diseases. On the other hand complexity of fructose metabolism in each individuals     results of the various magnitude of hyperuricemia induced by fructose intake. The magnitude     of uric acid production in each patient may reflect individual predisposition to endogenous     urate production in a face of relatively normal fasting uric acid concentration. Therefore     the oral fructose tolerance test might reveal an occult purine disturbances which plays     casual role in either metabolic disturbances or organ damage.      The aim of this study is to see whether is a relationship between fructose induced     hyperuricemia and metabolic disturbances , inflammatory state and organ damage in obese and     various stages CKD patients.   "
149099|NCT01332513|"     This is an open-label, single centre, repeat dose, up- titration study in healthy male and     female subjects to assess the pharmacokinetic (PK) performance of five prototypes of     ezogabine modified release tablet formulations.      The study will consist of a screening period, a treatment phase (consisting of a titration     phase, bioavailability phase and food effect phase) and a post-treatment follow-up visit. The     study duration from screening to follow up will be approximately 7 weeks. No study procedures     will start before informed consent is obtained. Subjects will remain in the clinical unit for     the duration of the treatment period (35 days).      Subjects will receive repeat doses of ezogabine for up to 34 days starting at a dose of 100     mg IR TID (300mg TDD) with a standard meal (to be consumed 30 min prior to dosing) for Days     1-3, on days 4-6 subjects will receive 150mg IR TID (450mg TDD). On Day 7 through to the end     of the study subjects will receive ezogabine (Mr or IR) at a dose of 600mgTDD.      On Day 7 subjects will enter into a 6-way cross over period to investigate the 5 MR     formulations being tested (each at 300mg BID) and the single IR formulation (at 200mg TID).     Subjects will receive each formulaition for 4 days and blood samples for pharmacokinetic     analysis will be collected up to 24 hours post dose on each 4th day (PK days).      On Day 31 subjects will enter into a food effect phase to investigate the 5 MR formulations     being tested (each at 600mg QD). Subjects in this period will have a PK day on Day 33     (following a standard breakfast), and on Day 34 (following a high fat breakfast) to     investigate a food effect on the PK profile of ezogabine.   "
149100|NCT01332500|"     The purpose of this retrospective claims database study was to compare the change in     migraine-related prescription (i.e. NSAIDs, Opioids, Ergots) utilization among migraine     suffers following initiation of Treximet ™ (sumatriptan/naproxen) compared with subjects     initiating treatment with other orally available triptans. The study was used to validate the     migraine-related prescription utilization patterns predicted by the Treximet ™ Budget Impact     Model.      The SourceLx dataset from the family of Wolters Kluwer databases was used for this analysis.     The database contains 30% of prescription claims filled in the United States (US),     approximately 160 million patient lives. The data has broad representative coverage at both     the geographic and payment levels.   "
149101|NCT01332487|"     This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase     inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of     acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as     prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized     for this study (2000-2008).   "
149102|NCT01332474|"     To collect the background characteristics of juvenile cerebral palsy patients aged 2-year or     older prescribed BOTOX for the treatment of equines foot due to lower limb spasticity,     compare them with those of patients whose deaths or adverse drug reactions (ADRs) related to     the possible spread of toxin are reported through the spontaneous ADR reporting system, and     discuss potential risk factors for such ADRs.   "
149103|NCT01332461|"     This was a retrospective cross-sectional database study using administrative data (study     period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged >40 years) having at least     one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and     496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index     event) during the study period was the target population. All subjects were required to have     one year of pre-index period baseline data. COPD events of interest were ER, Hospital and     physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days.     Other censoring events were treatment switch; loss of enrollment; >60-day gap between     medication fills; or end of study period.      This study is a non descriptive hypothesis testing study. Key study hypotheses are listed     below.      Specifically the study hypotheses for the primary outcome being tested were:      Ho: There is no difference in risk of COPD-related hospitalization between FSC and OMT Ha:     There is a difference in risk of COPD-related hospitalization between FSC and OMT      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:      Ho: There is no difference in COPD-related costs between FSC and OMT Ha: There is a     difference in COPD-related costs between FSC and OMT   "
149104|NCT01332448|"     Roche and GSK will carry out a meta-analysis of liver function data from trials of orlistat     to establish whether there is any indication of liver toxicity. The motivation is a     cumulative assessment of drug-induced liver injury (DILI) conducted by the FDA following     spontaneous reports of liver toxicity in people taking Xenical or Alli.   "
149105|NCT01332435|"     This retrospective study aims to assess the economic impact of early initiation of     5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving     5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information     Solutions and PharMetrics databases will be utilized for this study (2000-2007).   "
149107|NCT01332409|"     To investigate possible problems or questions in safety and effectiveness of salmeterol and     fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic /     emphysema). In this special drug use investigation, onset of pneumonia shall be handled as     the priority investigation item.   "
149108|NCT01332396|"     Data on the safety and efficacy of TYKERB shall be collected from the patients in order to     grasp the actual conditions of post-marketing use and assess background information on the     patients.   "
149113|NCT01332331|"     A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and     efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in     subjects aged 8 years up to 18 years with pulmonary arterial hypertension (PAH). An     additional objective is to determine the ambrisentan population pharmacokinetics in the     paediatric population. The study will include a screening/baseline period and a treatment     period. The treatment period will be 24 weeks or until the subject's clinical condition     deteriorates to the point that alternative/additional treatment is necessary. Patients who     participate in the study and in whom continued treatment with ambrisentan is desired will be     eligible to enrol into a long term follow-up study. The primary comparison will be the safety     and tolerability of the two ambrisentan dose groups (Low vs. High) in the paediatric PAH     population The secondary comparison will be the change from baseline for the efficacy     parameters between the two treatment groups.   "
149114|NCT01332318|"     This study was a multi center, randomized, double blind, active and placebo controlled,     parallel group study to assess simulated driving performance in XP13512 treated subjects with     Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose     of placebo (2 groups), XP13512 1200 mg, or XP13512 1800 mg for 16 days. On Day 16, one of the     placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the effects of     an agent known to have sedative properties, while the other 3 groups received a DPH placebo.   "
149115|NCT01332305|"     The objective of the study was to generate the data necessary to determine the gabapentin     exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo,     and the corresponding relief of symptoms in subjects with Restless Legs Syndrome (RLS).   "
149116|NCT01332292|"     This study will investigate the effect of dosing with flutucasone furoate in asthmatic     subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over     a 14 day treatment period, it will investigate safety, tolerability, pharmacokinetics and     serum cortisol levels.   "
149117|NCT01332279|"     This phase I trial studies the side effects and best dose of giving everolimus (RAD001) and     erlotinib hydrochloride together with radiation therapy in treating patients with recurrent     head and neck cancer previously treated with radiation therapy. RAD001 and erlotinib     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving RAD001 and     erlotinib hydrochloride together with radiation therapy may kill more tumor cells.   "
149118|NCT01332266|"     The purpose of this study is to determine whether patients with Platinum-Resistant Squamous     Cell Carcinoma of the Head and Neck who receive either E7050 administered with Cetuximab or     Cetuximab alone experience greater benefit   "
149119|NCT01332253|"     The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will     significantly reduce post-operative fentanyl use compared to placebo.   "
149120|NCT01332240|"     As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely     spread in Belgium, the investigators aimed to determine the number of mediastinoscopies     needed to detect one additional mediastinal lymph node invasion during routine clinical     practice in the staging of potentially resectable clinical stage III non-small cell lung     cancer.   "
149121|NCT01332227|"     The purpose of this study is to determine whether HIV-1—infected patients, who are     virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus     any third agent but are experiencing safety and/or tolerability issues, will maintain     virologic suppression after switching to a regimen of heat-stable ritonavir boosted     atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.   "
149122|NCT01332214|"     This is a randomised, single-blind, placebo-controlled Phase I study to investigate the     safety, tolerability and pharmacokinetics after administration of single doses of AZD2820 to     healthy male subjects.   "
149123|NCT01332201|"     Comparison of tacrolimus blood levels in adults who have received a transplant and are taking     either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is     followed by checking of safety and effectiveness for one year.   "
149124|NCT01332188|"     The purpose of this study is to evaluate the efficacy of different concentrations of AC-170     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in     the conjunctival allergen challenge (CAC) Model.   "
149125|NCT01332175|"     Randomised, placebo-controlled trial of continuous positive airway pressure therapy (CPAP)     versus Provent® and Placebo-Provent® to define the effects of Provent® on the severity of     obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk.   "
149126|NCT01332162|"     The purpose of this study is to evaluate the benefit of the optimal pacing configuration,     including the possibility of biventricular or left ventricular pacing, in hypertrophic     obstructive cardiomyopathy patients.   "
149127|NCT01332149|"     Pregabalin has proven effective in previous clinical trails in other countries in relieving     neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.      This study is being conducted according to China registration requirement to submit a     reapplication with new local diabetic peripheral neuropathy study as a commitment plus the     existing data to apply for Lyrica pain associated with postherpetic neuralgia indication     after Lyrica pain associated with postherpetic neuralgia is approved.   "
149128|NCT01332136|"     This research study will be completed by enrolling a prospective, observational cohort study     to evaluate medical versus surgical treatment outcomes for chronic sinus disease. This     investigation will compare quality of life outcomes between each treatment type, as well as     measure cellular and molecular markers of inflammation in the sinus mucosa, to create models     that predict improvement in quality of life following treatment.   "
149129|NCT01332123|"     This study is investigating the influence of several simulated real life conditions on the     symmetry of gait with trans-tibial prostheses      Hypotheses: It is hypothesized that the observable differences in gait pattern between     amputees can be detected by a combination of forces and moments that are measured internally     in the prosthesis, and electromyography data. It is further hypothesized that changing     conditions such as uneven walking surface, prosthetic misalignment or user fatigue are     characterized by typical values in the measured data or combinations thereof.   "
149135|NCT01332045|"     Our study will compare the use of continuous saphenous nerve block performed at the adductor     canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to     LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block     performed at the level of the adductor canal in addition to LIA provides better pain relief     than the LIA alone without significantly compromising muscle strength and physiotherapy,     enabling patients to mobilize early with reduced opioid consumption and les side effects.      The investigators will enroll a total of 40 patients (20 patients will receive continuous     saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until     discharge, the investigators will record patients' pain scores, opioid consumption, side     effects and physical therapy progress.      If our study proves that the continuous saphenous nerve block in addition to LIA can     effectively reduce postoperative pain scores to an acceptable level with better physical     therapy progress and less opioid consumption, it could be seen as a more attractive     alternative to LIA alone or other traditionally used methods of postoperative pain control     that compromises muscle strength and physiotherapy.   "
149136|NCT01332032|"     This randomized study compares the effectiveness and cost-effectiveness of 3 proven methods     of reaching out to women who are coming due for or who are overdue for a mammogram. The study     originally embedded in a community healthcare plan and an associated community clinic, now     accepts patients using the community clinic and 3 other health care plans. The study makes     use of a complex computer driven reminder system.      The study also will examine ways to improve the efficiency and sequencing of the     interventions by identifying patient factors associated with intervention effectiveness.   "
149137|NCT01332019|"     The primary objective of this study is to evaluate the long-term safety and tolerability of     peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301     (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this     study is to describe long-term multiple sclerosis (MS) outcomes in participants originally     treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.   "
149138|NCT01332006|"     For the great majority of hematological malignancies, hemopoietic stem cell (HSC) transplant     is the only possible cure. The source of HSC is usually bone marrow (BM) or peripheral blood     cell (PBSC) mobilized by granulocyte growth factor. Transplant needs a HLA compatible donor     weather related or unrelated. A suitable compatible donor can be found in at least 70% of the     patients. Thus, at least 30% of patients with indication for allogeneic HSC transplant are     not able to undergo the procedure because of the lack of a HLA compatible donor. Cord blood     (CB) cells represent another possible source, that needs a lower degree of HLA compatibility.     CB transplant, however, offers a lower number of HSC. Thus, adult patient rarely may benefit     from this source of stem cells, mainly beacuse thie body weight is too high to have ad     adequate number of cell per kg. Recently, experimental animal models confirmed that an     adequate recovery of allogeneic hemopoiesis can be achieved via intrabone injection, using a     1Log lower number of cells compared to the intravenous way (Yahata 2003, Castello 2004).     Safety and feasibility of intrabone infusion was verified by two clinical studies on humans:     the first was conducted by Ringden O. et al. in 18 patients using BM as a source of SC. No     side effects and complete engraftment of donor hemopoiesis was observed; the second one was     conducted by Frassoni et al. (Frassoni 2008) with CB as the source of HSC.      The aim of this study is to evaluate the intrabone infusion of compatible CB in patients with     haematological malignancies lacking a HLA matched donor.      We will perform:      evaluation of the engraftment kinetics; evaluation of the chimerism degree at 30, 60, 100     days, 6 months and 1 year after transplant; studies on immunological reconstitution and the     role of the NK compartment.   "
149139|NCT01331993|"     The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO     manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as     VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen     formulation.   "
149160|NCT01331720|"     The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian     hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females     undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro     fertilisation/intracytoplasmic sperm injection).      Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary     hMG (human menopausal gonadotropin)should be more effective than monotherapy.   "
149245|NCT01330602|"     The primary objective of this study is, to instigate a reduction in atherosclerotic burden     within the carotid arteries in the intervention group compared to the control group and to     demonstrate parallel improvements in cardiovascular and overall health status relative to     usual care   "
149140|NCT01331980|"     Cystic fibrosis (CF) affects an estimated 30,000 people in the United States and is caused by     a mutation in the gene encoding a protein called CF transmembrane regulator (CFTR). The     hallmarks of CF are recurrent pulmonary exacerbations and declining pulmonary function.     However, there are other problems in CF that affect both health and quality of life. These     include CF related diabetes, liver disease, and bone disease. The median age of survival for     patients with CF has been increasing steadily and is currently more than 37 years. With this     improvement in life expectancy, it has become increasingly important to address the long-term     complications of CF.      Currently, patients with CF are evaluated annually for bone disease with dual X-ray     absorptiometry (DXA), and screening usually starts at age 12. However, this may not be     sufficient to detect early bone changes that may impact fracture risk. Furthermore, bone     disease in children may manifest earlier than adolescence, which would suggest that screening     should start at an earlier age in these vulnerable patients. The following study is therefore     proposed to examine the potential role of peripheral quantitative computed tomography (pQCT)     as a screening approach for bone disease in children with CF. The investigators expect to     find bone problems by pQCT but not DXA.   "
149152|NCT01331824|"     The primary objective of this study is to determine in subjects with metastatic measurable     bladder cancer (or urothelial cancers originating elsewhere in the genitourinary tract) who     have progressed on 1 prior chemotherapeutic regimen the objective response rate to treatment     with amrubicin. The secondary objectives will be to evaluate progression-free survival,     survival at 1 year, and the safety of amrubicin as second-line therapy in patients with     metastatic urothelial carcinoma.   "
149141|NCT01331967|"     Pioglitazone is used in the treatment of diabetic patients. Thiazolidinediones increase     insulin sensitivity and show favorable effect on blood glucose levels and lipid profiles. The     effect of pioglitazone on atherosclerotic and inflammatory markers has not been compared in     prospective manner after everolimus-eluting stent implantation by OCT. The purpose of this     prospective, randomized, open-label trial is to compare the effect of pioglitazone on     neointima volume and atherosclerosis progression in type 2 diabetic patients by using OCT.     Moreover, changes in neointima characteristics could be analyzed along with the changes in     miRNA-21, -126, -143, -145. Major adverse cardiovascular events such as non-fatal MI, death,     stroke, and TLR could be compared.   "
149142|NCT01331954|"     Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast     fibroadenoma.   "
149143|NCT01331941|"     This is a phase 1, open-label pharmacokinetic study where up to 40 subjects with advanced     solid tumors (up to 6-10 with normal renal function and up to 18-30 with varying degrees of     renal dysfunction) will receive weekly doses of AMG 386 intravenously. The primary objective     is to evaluate the pharmacokinetics (PK) of single agent AMG 386 in subjects with various     degrees of renal function. Once the AMG 386 PK characterization is complete in the first 5     weeks of the study, all subjects will be allowed to continue to receive AMG 386 weekly only     or subjects in group 1, 2 or 3 can opt to receive AMG 386 weekly in combination with     paclitaxel until disease progression, unacceptable toxicity or withdrawal of consent.   "
149144|NCT01331928|"     The purpose of this study is to determine whether sequential chemotherapy with capecitabine     plus oxaliplatin (Xelox) followed by docetaxel plus capecitabine (TX)in unresectable gastric     cancer.   "
149145|NCT01331915|"     In this phase I study, the investigators want to vaccine with THERAVAC® (an inactivated toxin     coupled to melanoma antigen) some patients with advanced metastatic melanoma disease.      The primary objective is to analyze the safety of the inreasing doses of vaccine.      The secondary objective is to document whether this vaccine can induce tumor regression in     immunized patients.   "
149146|NCT01331902|"     The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of     maximal coronary hyperemia compared with adenosine.   "
149147|NCT01331889|"     Rapid infusion of red blood cells is known to result in hyperkalemia in the body. However,     potassium concentration in the blood mixture (usually made of RBC, FFP and normal saline) in     the reservoir of rapid infusion system and its effect on the plasma potassium change during     rapid transfusion are unknown. This study is designed to investigate these changes while     massive transfusion is performed during liver transplantation surgery.   "
149148|NCT01331876|"     Obsessive compulsive Disorder (OCD) is a frequent psychiatric disorder. Obsessions and     compulsions are the two manifestations of this disease. Obsessions are recurrent anxious     ideas, and compulsions repetitive behavior aiming to decrease this anxiety.      OCD symptoms have been associated with cortical and sub-cortical dysfunctions and more     precisely an hyperactivity of prefrontal cortex / basal ganglia loops.      Functional neuro-imagery studies have shown a significant decrease of orbito-frontal cortex,     anterior cingulate cortex, caudate nucleus and cerebellum activities after two OCD reference     treatments : medication and Cognitive and Behavioral Therapy (CBT).      Two groups of 20 patients are included in this study and follow a CBT for 15 sessions. They     are randomised in two groups : one proposing a reference CBT, the other associate CBT to a     new psychopedagogic task developed by the investigators team.      Clinical investigations and neuro-imagery data are collected at the main steps of therapies :     before, during (half-therapy), at the end of therapies and 6 month later. Symptoms severity,     patients and relatives quality of life are also assessed.   "
149149|NCT01331863|"     -  First study (BRONC-ART) The purpose of this prospective study is to evaluate the 90-day          morbidity and mortality rates of bronchial transplantation using cryopreserved aortic          allograft in proximal lung cancer surgery. The investigators hypothesize that this stage          1-2 surgical innovation could be safe and effective in order to reduce the 90-day          morbidity and mortality rates compared to those observed with pneumonectomy, especially          when some factors are present: age > 70 years, right side, neoadjuvant          chemoradiotherapy.        -  Current study (TRACHEO BRONC-ART) The BRONC-ART study was extended to major (malignant          or benign) lesions of the trachea requiring airway transplantation.      For these patients, resection followed by direct end to end anastomosis is not possible or at     high risk.   "
149161|NCT01331707|"     The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has     led to a significant reduction in morbidity but there are further demands on DES performance.     Such demands are an optimized performance in very challenging coronary lesions; third     generation DES were developed in an effort to further improve DES performance in such     challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus     Element stents) are currently available; there are no data that indicate an advantage of one     of these DES over the other.   "
149453|NCT01327820|"     To define any changes in whole body oxygen consumption that occur following major vascular     surgery (open aortic aneurysm surgery; endovascular aortic aneurysm repair; and     infra-inguinal lower limb revascularisation procedures).   "
149150|NCT01331850|"     This randomized, open-label, multi-center study will evaluate the sustained virological     response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with     Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection.     Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will     be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to     Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir     100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg     twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive     Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day     for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180     microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.     In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus     treatment.   "
149166|NCT01331642|"     Gaucher disease is an autosomal recessive hereditary lysosomal storage disorder. Occurrence     of the disease is due to a hereditary deficiency of the Glucocerebrosidase, a lysosomal     enzyme which divides Glucocerebroside in to Glucose and Ceramides.   "
149153|NCT01331811|"     Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the     difficulty of its diagnosis is increased in case of HIV infection in children.      The aim of this study is to improve TB diagnosis in HIV-infected children by developing a new     diagnostic algorithm incorporating new tools available such as:        -  interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test        -  alternative specimen collection methods such as string test (or Enterotest (R)),          nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate        -  the Xpert MTB/RIF assay   "
149154|NCT01331798|"     A blinded, prospective, randomized trial in 40 abdominoplasty cases at three sites to study     the safety and the preliminary efficacy of TissuGlu®, a novel surgical adhesive, in the     management of wound drainage during abdominoplasty procedures.   "
149155|NCT01331785|"     Ascites is a frequent complication of patients with portal hypertension. As portal     hypertension progresses, a percentage of these patients develop refractory ascites.     Management options at that point include either TIPS or intermittent large volume     paracentesis (LVP), with its attendant risks, Portal hypertension is accompanied by systemic     circulatory dysfunction (decreased systemic vascular resistance and systolic BP), which is     exacerbated by large volume paracentesis, with resultant renal and cardiac dysfunction. There     are limited options for managing patients with acute decompensation, such as hepatorenal     syndrome, although midodrine and other vasoconstrictors have been used in such patients.     Midodrine has not been used as a possible therapeutic for ascites. Midodrine however, has     been found to change the hemodynamics related to portal hypertension and ascites. There has     been also change in mediators related to renal and circulation in studies of short duration     (7 days) but not found in studies of 1 month duration, however the clinical effects of     midodrine is found for longer duration in other similar conditions.      The purpose of the study is to assess the utility of midodrine in patients with obvious     systemic circulatory dysfunction (hypotension) in improving the outcome of patients with     refractory ascites and change in hemodynamic parameters and its mediators.      Specific endpoints include:      1) an objective reduction of the volume/rate of accumulation of ascites and 2) a decrease in     the frequency of LVP.   "
149156|NCT01331772|"     Breast cancer is the most common cancer in women. Weight gain in adulthood, overweight or     obesity, physical inactivity and alcohol consumption are risk factors commonly associated     with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Reduced     physical activity is one factor likely to weight gain in women after adjuvant chemotherapy     for localized breast cancer. Furthermore, physical activity appropriately could improve many     prognostic factors and survival of women after breast cancer. Adapted Physical Activity (APA)     could improve fitness, quality of life, body image, treatment compliance and reduce fatigue.      After diagnosis of breast cancer, there is many possible risk factors of mortality or     morbidity related to nutritional factors available to management. These risks prevention     through management of these patients appears indispensable through an APA program.      Thus, the investigators propose to test the feasibility of implementing a program of dietary     intervention and APA to prevent the risk of weight gain (which affects more than half of     patients) and maintain and/or increase their level of physical activity during and after     adjuvant chemotherapy.   "
149157|NCT01331759|"     Neuropattern™, a new diagnostic tool for stress related disorders is being applied in a     demanding workplace environment. Neuropattern™ aims at identifying stress-related bodily     changes at an early stage. By identifying subgroups based on Neuropattern™ subjects gain     access to online counseling specified according to their Neuropattern™ diagnosis. Efficacy is     being assessed by several questionnaires in a follow-up.   "
149158|NCT01331746|"     A study to look at the effectiveness of a drug called APD515, designed to be applied to the     lining inside the mouth, at relieving dryness of the mouth. Study will compare one week of     treatment with APD515 to one week of treatment with matching placebo to see which has better     effect on patient's mouth dryness, according to their own score.   "
149159|NCT01331733|"     To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary     gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in     females undergoing intrauterine insemination.      Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more     effective than monotherapy.   "
149196|NCT01331252|"     This is a randomised controlled trial of the incidence of nosocomial pneumonia in patients     with severe tetanus admitted to the intensive care ward nursed in a supine or semi-recumbent     position.   "
149162|NCT01331694|"     To evaluate COPD-related clinical outcomes and total healthcare utilization in commercially     insured (at least 40 years with a subanalysis of those aged 65 years and older) COPD     population associated with the use of fluticasone/salmeterol combination (FSC) 250/50mcg     compared to other initial maintenance therapies (IMTs), specifically, tiotropium bromide     (TIO), and either ipratropium bromide or ipratropium bromide/albuterol (IP).      This is a hypothesis testing study      Ho: There is no difference in time to first COPD-related events between FSC and TIO and FSC     and IP Ha: There is a difference in time to first COPD-related events between FSC and TIO and     FSC and IP      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:      Ho: There is no difference in COPD-related costs between FSC and TIO and FSC and IP Ha: There     is a difference in COPD-related costs between FSC and TIO and FSC and IP   "
149163|NCT01331681|"     To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the     best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy     study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement   "
149164|NCT01331668|"     This study aims to maintain a prospective biobank of human samples obtained from donors and     recipients of renal allografts, including biopsy tissue, peripheral blood samples and urine     samples.   "
149165|NCT01331655|"     The objective of this three-arm study is to evaluate the effect of a flexible extended     regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance     with daily pill intake when the investigational product is provided in a blister package or a     compliance aiding dispenser with a pill reminder function. The third treatment arm will be a     reference comparator arm of a standard 24+4 regimen of the identical hormone combination.   "
149167|NCT01331629|"     The purpose of this study is to compare intervention by Art-therapy to standard care in     patients treated with adjuvant radiotherapy for breast cancer and evaluate the fatigue.   "
149169|NCT01331603|"     Recently, it has been demonstrated that iron overload is associated with the appearance of     labile plasma iron (LPI).      LPI is redox active and is rapidly taken up by cells, leading to a rise in the labile iron     pool (LIP) and catalyzing generation of reactive oxygen species (ROS), which can lead to     cellular damage.      The LPI data are mostly derived from thalassemia iron overload research , however, there are     a few data describing LPI and its correlations with the classical iron overload parameters     (ferritin, TSAT) in acute anemias such as MDS Therefore we are going to assess LPI in iron     overloaded myelodysplastic syndromes (MDS) (low and high risk) and primary myelofibrosis, in     order to assess whether it can be used as alternative to the routinely used parameters; TSAT     and ferritin levels.   "
149170|NCT01331590|"     The purpose of this study is to determine the ability of G-CSF to disrupt the bone marrow     microenvironment as a means to increase the efficacy of chemotherapy in patients with     relapsed or refractory acute lymphoblastic leukemia (ALL).   "
149171|NCT01331577|"     Stress is a common problem with significant consequences for health. It can be a trigger for     somatic diseases as well as psychological disorders and leads through missed working days and     healthcare cost to a high economic loss. It is for health and economic reasons essential to     develop and evaluate effective interventions that can inoculate against stress and build     inner strength.      A cognitive-behavioural training for groups that is well evaluated and has shown to be     effective is the Stress-Inoculation-Training by Meichenbaum. As the public utilization of     methods of the complementary and alternative medicine is increasing a rigorous evaluation is     needed. Integrative Kinesiology is a popular method that has been said to be effective     against stress and its symptoms.      The investigators propose a randomized controlled evaluation and comparison of the     interventions to each other and to a waiting-list control group. Hypothesis: Healthy     volunteers attending a two dayseminar will show significantly reduced psychobiological     reactivity, decreased stress perception and less anxiety to a standardized psychosocial     stress test compared to the waiting list group. A total of 64 healthy volunteers will be     randomly assigned to one of the three groups. The efficacy of the interventions will be     measured through the Trier Social Stress Test (TSST) to measure the psychobiological stress     reactivity.   "
149172|NCT01331564|"     The project aims to develop, implement and evaluate electronically-mediated behavioral     intervention programs for pregnant and postpartum women in order to prevent excessive weight     gain during pregnancy and postpartum weight retention.   "
149173|NCT01331551|"     The purpose of this study is to investigate the relationship of high exposure to dibutyl     phthalate (DBP) from the use of Asacol with clinical and intermediate markers of male     fertility, including semen quality, sperm DNA damage, transcript profiles of sperm mRNA and     sncRNAs, and reproductive hormones.      Hypothesis 1: High exposure to DBP from the use of Asacol is associated with decreased sperm     concentration and motility, and increased sperm DNA damage.      Hypothesis 2: High exposure to DBP from the use of Asacol is associated with decreased serum     testosterone, altered LH:testosterone ratio, and decreased inhibin-B.      Hypothesis 3: High exposure to DBP from the use of Asacol is associated with altered     transcript profiles of sperm mRNAs and sncRNAs.   "
149174|NCT01331538|"     The aim of this research was to determine the existence of a correlation between the degree     of temporomandibular dysfunction and cervical posture in different occlusal classes in     adolescents. A cross-section, observational study was carried out, in which 296 adolescents     took part. For the evaluation, the patients were divided into groups according to the     presence and severity of the temporomandibular dysfunction, using a questionnaire and     occlusal Angle classification. The posture analysis was carried out using photogrammetry and     the software Alcimage® to measure the predefined angle based on the protuberances of the     Spinous Process of the 7th Cervical Vertebra (C7), Manubrium of the sternum and Mentum     Vertex.   "
149175|NCT01331525|"     This trial will investigate the addition of an antibody (Ipilimumab) to conventional     Carboplatin and Etoposide chemotherapy in extensive stage small cell lung cancer.      The primary objective is to establish the progression free survival at 1 year.   "
149176|NCT01331512|"     Background:      - Older persons are often referred to physicians because of mobility difficulties that grow     worse as they age. To better understand the reasons for mobility difficulties in older     persons, researchers conducted a population-based study of individuals living in the Chianti     geographic area of Tuscany, Italy. Researchers are now interested in conducting a follow-up     study on the original participants to assess the effects of aging on their mobility.      Objectives:      - To conduct a follow-up study on the participants in the mobility study of older persons in     the Greve in Chianti and Bagno a Ripoli areas near Florence, Italy.      Eligibility:      - Original participants in the InChianti Mobility Study.      Design:        -  The InChianti Follow-up Study will repeat most elements of the baseline evaluation from          the original study. Participants will be seen on the 3-year anniversary of their          baseline study assessment.        -  Participants will have a home interview with questions about their physical and mental          health, family history, daily activities, and living conditions related to their          continued mobility.        -  Participants will provide blood and urine samples, and will have tests of heart and          motor nerve function and imaging studies of bones and the circulatory system.        -  Participants will also have a functional evaluation of their motor skills, including          walking tests, range of motion tests, and grip strength.   "
149177|NCT01331499|"     The purpose of this study is to compare standard of care hemostasis techniques with and     without the use of Aquamantys in reducing peri-operative blood loss.   "
149178|NCT01331486|"     Prehypertension and mild hypertension affect an estimated 157 million U.S. adults.     Cardiovascular disease (CVD) risk and associated mortality is elevated in this population.     Treatment options are limited consisting of lifestyle modification, which is often     ineffective, or drug therapy, which carries risk of side effects. Highly safe, efficacious,     and acceptable treatment options for this population are needed. Hawthorn standardized     extract (HSE) is approved for use in Europe to treat heart failure, and preliminary evidence     suggests it may have a blood pressure lowering effect. However, prior trials of hawthorn have     based dosage recommendations on animal studies. Therefore, the investigators propose a     dose-finding study to measure the pharmacodynamic effect of three doses of standardized     hawthorn extract and placebo.   "
149191|NCT01331317|"     The primary objective is to assess the impact of three months of treatment with an active     vitamin D analogue on a risk marker for excess overall mortality and cardiovascular     morbidity/mortality in Type 1 diabetic patients with diabetic kidney disease. The hypothesis     is that active vitamin D analogue treatment reduces the risk of cardiovascular morbidity and     mortality in patients with type 1 diabetic kidney disease.   "
149192|NCT01331304|"     The purpose of this study is to compare the effectiveness of lithium and quetiapine for the     treatment of individuals with bipolar disorder.   "
149193|NCT01331291|"     For many brain tumors, one reason that chemotherapy drugs might not be effective is that the     drug may not be able to get into the brain tumor and kill the cancer cells. The brain is     protected by a layer called the blood brain barrier. This barrier prevents substances from     entering. The purpose of this research study is to determine if bosutinib can get past the     blood brain barrier and into the brain tumor, and to see how well bosutinib works in killing     cancer cells.   "
149194|NCT01331278|"     The custom cutting guides personalized for each patient via pre-operative MRI will result in     significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee     function, and patient satisfaction.   "
149195|NCT01331265|"     The goal of this study was to examine the effects of self-perceived lactose intolerance     (SPLI) as it relates to calcium intake and specific health problems that have been attributed     to reduced intake of calcium and foods from the dairy group in a nationally representative     multi-ethnic sample of adults.   "
149197|NCT01331239|"     This exploratory study is a proof of concept study to determine whether LCI699 can safely     reduce the level of urinary free cortisol in patients with Cushing's disease. In addition,     this study will evaluate the long term efficacy and safety of LCI699 including an additional     12 week of treatment followed by a 12 month long term optional extension. A second extension     will provide patients who are clinically benefitting from LCI699 an opportunity to continue     to have access to the drug until LCI699 is commercially available and reimbursed or through     the availability of a local access program.   "
149198|NCT01331226|"     This study is designed to examine if a telephone-based intervention delivered to a support     person (i.e., friend, spouse of a smoker) increases the smoker's use of the Minnesota     helpline. In addition, the study will examine if the rate of smoker calls to the helpline is     greater if the support person receives 3 intervention calls, 1 intervention call, or no calls     (written materials only, control condition).   "
149199|NCT01331213|"     The general aim of the current study is to describe the effect of pregabalin on colonic and     sensory functions in adults with constipation predominant irritable bowel syndrome (IBS-C).      Study hypotheses:        1. Single-dose pregabalin 200mg increases sensation thresholds and decreases sensation          ratings in response to balloon distension in the colon relative to pre-pregabalin          treatment.        2. Single-dose pregabalin 200 mg will increase colonic compliance and decrease colonic pain          and gas thresholds in patients with irritable bowel syndrome constipation predominant.        3. Single-dose pregabalin 200mg increases the colonic phasic and tonic response to a          standardized meal.   "
149200|NCT01331200|"     The purpose of this study is to study the safety and feasibility of mobilization of acute     ischemic stroke patients treated with IV-tPA between 12-24 hours of treatment.   "
149201|NCT01331187|"     Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical     department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia,     hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall     bladder/bile tract, urine tract and venous thrombosis are common. US is the key diagnostic     tool in these diagnosis, and on early diagnosis is crucial with respect to the patients     well-being and inpatients workflow.      1. The aim is to study the clinical use of pocket-size US as a screening diagnostic tool in     an medical department with respect to inpatients workflow and diagnostics.      Method: Patients admitted (in certain preset periods) to Department of medicine will be     randomized to routinely adding an ultrasound examination with pocket-size device by residents     on call. Time to definitive diagnosis, time to definitive treatment and time to discard will     be recorded. US findings will be validated against standard echocardiography, or standard     US/CT/MRI performed at the Radiological department.   "
149202|NCT01331174|"     Study design: Randomized clinical trial. Objective: To evaluate the effect of PSW treatment     in different doses and to compare to the control and placebo group.      Background: Several forms of conservative treatment have been the focus of many recent     studies in knee osteoarthritis (OA). Among these techniques, the application of pulsed short     wave has been widely used, but the optimal dose and application time still have not been well     established.   "
149203|NCT01331161|"     Vaccination is the most effective way of preventing infectious diseases. Despite the success     of vaccines in general, vaccines induce diminished antibody responses and lower protection in     the elderly in particular. This could be explained by a defect in the early responses of an     ageing immune system. A better understanding of the basic immunological mechanisms that     mediate vaccine efficacy is incomplete. Such information is critical and could greatly     decrease both the cost and the time to new vaccine development particularly for the geriatric     population.      In this trial, the investigators will study the immunologic differences of the FDA approved     licensed shingles vaccine between a younger and an older group. Thirty three healthy     volunteers between the ages of 25-40 and forty four healthy volunteers between the ages of     60-79 will be enrolled in the study. Each participant in the study will be given one shingles     shot. Blood work will be obtained one month before vaccination, on the day of vaccination,     one day, three days, seven days, fourteen days, one month, three months and six months after     vaccination. Throughout the duration of the study, the participants will be monitored for     safety.   "
149239|NCT01330680|"     Cardiovascular and neuropsychologic effects of coffee are still debated. The precise     mechanism underlying the actions of caffeine on the cardiovascular and neuropsychologic     systems is incompletely understood and a considerable variability in the response to coffee     drinking was observed, in part ascribable to a genetic trait.      The aim of the study is to evaluate acute cardiovascular and neuropsychologic effects of     coffee and explore whether such effects are influenced by the genetic asset of caffeine     metabolism (by a polymorphisms of cytochrome P450 1A2), adenosine metabolism (by     polymorphisms of adenosine receptor and adenosine monophosphate deaminase) or catecholamine     receptors (by polymorphisms of adrenergic receptors).   "
149204|NCT01331148|"     Vitamin D deficiency (VDD) is very common among African American adolescents and adults in     the US, ten times higher than is seen in Caucasians. VDD is also quite common in sickle cell     disease (SCD). Both VDD and SCD can cause chronic pain, compression fractures, and muscle     weakness. The investigators believe VDD may contribute to poor musculoskeletal health and     chronic pain seen in pediatric SCD. In this study, the investigators aim to show that     children and adolescents with SCD and chronic pain have lower levels of vitamin D compared to     those without chronic pain. The investigators also aim to determine the clinical     characteristics in SCD patients related to their vitamin D status.      About 60 subjects (7 to 21 years old) will be enrolled on this study, 30 with chronic pain     and 30 without chronic pain. The investigators will assess baseline characteristics including     vitamin D levels, bone turnover rates (measured by C telopeptide blood levels [CTx]), markers     of inflammation and oxidative stress levels in blood, baseline hemoglobin and other     laboratory parameters, presence of abnormal bones on chest x-ray, pulmonary function, opioid     analgesic use, overall muscle strength, quality of life and depression.      To evaluate the impact of vitamin D replacement on these baseline characteristics, the     investigators will randomize subjects to receive either placebo or high dose vitamin D for 6     weeks after which time the investigators will evaluate overall vitamin D status, muscle and     bone health, depression, quality of life, pain status and use of opioid pain medications,     inflammation and oxidative status comparing before and after treatment with high dose vitamin     D. The investigators will give—at no cost to subjects—a daily supplement that will provide     the recommended daily allowance of calcium and vitamin D that contains 500mg Calcium and     200IU vitamin D to subjects throughout the study period. Subjects will be in the study for 7     months and have five to six study visits.   "
149215|NCT01331005|"     This study is being conducted to assess the effects of topical nonsteroidal     anti-inflammatories (NSAIDs) on macular retinal volume compared with placebo in eyes with     non-central diabetic macular edema (DME). A secondary objective of this study is to assess     the effects of topical NSAIDs on central subfield thickness and to compare the progression of     non-central DME to central DME as determined by optical coherence tomography (OCT) and     stereoscopic fundus photographs. Furthermore, this phase II study is being conducted (1) to     determine whether the conduct of a phase III trial has merit based on an anatomic outcome,     (2) to estimate recruitment potential of a phase III investigation, and (3) to provide     information on outcome measures needed to design a phase III trial. The study is not designed     to establish the efficacy of NSAIDs in the treatment of non- central DME.   "
149482|NCT01327430|"     The aim of the study is to investigate parameters of the lipid metabolism in plasma and feces     of healthy subjects after a dietary supplementation of different dosages of milk     phospholipids.   "
149205|NCT01331135|"     The best treatment for recurrent cancers or those that do not respond to therapies is not     known. Typically, patients with these cancers receive a combination of cancer drugs     (chemotherapy), surgery, or radiation therapy. These treatments can prolong their life but     may not offer a long-term cure.      This study proposes using a drug called Sirolimus in combination with common chemotherapy     drugs to treat patients with recurrent and refractory solid tumors. Sirolimus has been found     to inhibit cell growth and to have anti-tumor activity in pediatric solid tumors in previous     studies and, therefore, has the potential to increase the effectiveness of the chemotherapy     drugs when given together.      This study wil investigate the highest dose of Sirolimus that can be given orally with other     oral chemotherapy drugs. Cohorts of 2 subjects will be started at the minimum dose. The dose     will be increased in the next 2 subjects as long as there were no major reactions in the     previous groups. This study will also seek to learn more about the side effects of sirolimus     when used in this combination and what effects the drug has on the white cells and the immune     system. Successful use of this drug will impact the cancer population greatly by providing an     increased chance of survival to those with resistant or recurrent cancers.   "
149206|NCT01331122|"     Freezing of Gait (FoG) is a class of symptoms that occur in Parkinson's patients. Also called     motor blocks, FoG is characterized by a sudden inability to move the lower extremities which     usually lasts less than 10 seconds. The exact pathophysiology of FoG is poorly understood,     but treatment with levodopa appears to improve FoG observed in the off-state. As Parkinson's     patients progress in severity, FoG in the on-state can increase in frequency and appears to     be resistant to dopaminergic therapies. There is additional evidence that norepinephrine as     well as dopaminergic systems may be involved in FoG.      Droxidopa has has been approved for use in Japan since 1989 for treatment of frozen gait or     dizziness associated with Parkinson's Disease. This study is to further explore the safety     and efficacy of droxidopa in this indication.   "
149207|NCT01331109|"     The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in     pediatric patients aged 13 to 17 years with primary fibromyalgia.   "
149208|NCT01331096|"     Patients in Pisa will undergo thyroid gland surgery. In the protocol group anesthesia will be     performed using an automated anesthesia delivery system; preoperative and intra-operative     assessment of patients will be performed via video-conferencing from Montreal, which will     also monitor and control anesthesia delivery via distant Internet connection - as supervision     of functioning of the automated anesthesia delivery system. In the control group anesthesia     will be performed in a standard fashion with manual control of the syringe pumps infusing     anesthetics drugs.      The hypothesis is that Tele-anesthesia, considered as preoperative assessment and anesthetic     control of an automated anesthesia delivery system is feasible and reliable via standard     means of internet communication (distant control via virtual network) and performed as well     or even better than manual control of the anesthetic drugs infusion.   "
149209|NCT01331083|"     The purpose of this study is to find out whether the new drug PX-866 will slow the growth of     your prostate cancer. The investigators will also watch you carefully for any side effects     that PX-866 might cause.   "
149236|NCT01330719|"     Although of low prevalence, aggressive periodontitis is a rapid destructive form of     periodontal disease that initiates at a young age, leading to premature loss of first molars     and incisors. Little is known on the mechanisms of this disease. It is imperative to     understand mechanisms of disease to establish proper treatment. We have established a     controlled study in a comparable population presenting similar aggressive disease     characteristics to evaluate the mechanisms of this disease. It is the goal of this study to     determine immunological and microbiological mechanisms responsible for the rapid tissue     destruction in children with localized aggressive periodontitis and how traditional     periodontal intervention affects these mechanisms. Important knowledge gained with this     proposal will aid in defining specific treatment approaches to better control disease     progression and prevent disease initiation in susceptible individuals.   "
149237|NCT01330706|"     The investigators conducted a controlled, prospective randomized study to examine the     antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.   "
149210|NCT01331070|"     Chronic obstructive pulmonary disease (COPD) is a chronicle inflammatory disease with a non     reversible diminution of the airway flow. COPD is caused most commonly from tobacco smoking,     which triggers an abnormal inflammatory response in the lung. Worldwide, COPD ranked as the     sixth leading cause of death in 1990. It is projected to be the fourth leading cause of death     worldwide by 2030 due to an increase in smoking rates and demographic changes in many     countries. COPD is responsible for 16000 deaths per year in France, 100 000 hospitalizations     per year and the health care expenditure of COPD in France is 3.5 billion of Euros. Classical     markers of the disease severity, the forced expiratory volume in one second, poorly     correlates with dyspnea and prognosis. Therefore, many studies focused on the control of     breathing in an attempt to understand the pathophysiological mechanisms involved in the     progression of the disease. Breathing control is enhanced in patients with COPD due to the     progressive failure of respiratory muscles (airflow obstruction, static and dynamic     hyperinflation, positive intrinsic end expiratory pressure), the ventilation/ perfusion ratio     abnormalities leading to the loss of the gaz exchange efficiency. Inspiratory command depends     on the medulla automatic pathway and the voluntary corticospinal command. Indirect method of     breathing control estimation suggested in COPD patients an increased excitability of neurons     involved in the voluntary diaphragm activation and a reduced cortical reserve. This may     represent an increase risk factor for acute respiratory failure. Until now, no study reported     the central breathing control with cerebral fMRI in COPD patients.   "
149211|NCT01331057|"     The primary purpose is the validation of an instrument of the first language assessment. The     second purpose is to study the impact of familial and transcultural factors on early     bilingualism in migrant children born in France.   "
149212|NCT01331044|"     1. RUTF would be more effective (quicker catch-up growth by promoting more tissue accrue          resulting decrease stay in rehabilitation ward) in treating children with SAM during the          rehabilitation phase than khichuri /halwa;        2. RUTF would be acceptable to the children and their mothers/caregivers;        3. Malnutrition is not caused solely by lack of food, but also by impaired utilization of          the food that is ingested. The ability of the gut to absorb nutrients from the diet is          associated with the host's 'human' genotype, the host's gut microbiota and its gene          content (the microbiome).   "
149213|NCT01331031|"     The disorders that affect the temporomandibular joint (TMJ) are responsible for the diverse     symptoms. Objective: To evaluate whether or not the relationship between signs or symptoms of     TMD and presence of harmful habits. The investigators evaluated 244 adolescents enrolled in     public school . The investigators used the questionnaire for selection of orofacial pain and     temporomandibular disorders, recommended by American Academy of Orofacial Pain to assess the     presence or absence of signs and symptoms of TMD.   "
149214|NCT01331018|"     This pilot clinical trial will access the toxicity and efficacy of infusion of gene modified     cells for patients with Fanconi anemia (FA). Infusion of autologous patient blood stem cells     that have been corrected in the laboratory by introduction of the normal gene may improve     blood counts in patients with FA.   "
150729|NCT01309971|"     The purpose of this study will allow us to observe and follow the subjects' treatment from     DPBRN Prevalence of Questionable Occlusal Caries Lesions Study over a 24 month period.   "
149216|NCT01330992|"     The mammalian eye serves both visual and non-image-forming functions. New information about     the non-image-forming anatomy and physiology of the eye has revealed effects of ocular light     stimuli on human circadian rhythms, melatonin suppression, heart rate, pupillary reflexes,     cognitive performance, alertness and sleep. The results of the proposed work can be used to     make predictions about the effects of light, to make recommendations involving exposure to or     avoidance of light, and to design environmental lighting, resulting in improved health and     alertness and decreased errors and accidents.   "
149217|NCT01330979|"     An open-label, non-comparative, pilot evaluation of the 24-hour ocular hypotensive efficacy     of AR-12286 in patients with open-angle glaucoma or ocular hypertension   "
149218|NCT01330966|"     The purpose of this study is to determine the effectiveness and safety of single agent     pazopanib in subjects with chondrosarcoma.   "
149219|NCT01330953|"     The purposes of this study are (1) To determine the safety of LY2928057 in healthy people,     and any side effects that might be associated with it; (2) To understand how the body of     healthy people handles LY2928057; (3) To determine the effect of LY2928057 on blood iron     level in people's body; and (4) To evaluate how people's immune system reacts to LY2928057.   "
149220|NCT01330940|"     Beverages containing citrate may be useful in increasing urine citrate content and urine pH.     Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more     citrate than other similar beverages. The investigators are interested in whether diet soda     will improve urine chemistry in the appropriate manner.   "
149221|NCT01330927|"     The purpose of this study is to establish the dose response relationship of VA106483 and     nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic     Hypertrophy (BPH) who are likely to present with nocturia.   "
149222|NCT01330914|"     Obesity is a chronic illness of staggering proportions. Because weight loss through diet and     exercise is difficult to attain and maintain, there has been escalating interest in bariatric     surgery, including Roux-en-Y gastric bypass. Gastric bypass surgery results in long-term     weight loss, dramatic improvement in comorbidities such as diabetes, and decreased mortality.     Emerging evidence suggests, however, that gastric bypass may have negative effects on bone     health. Because of the serious consequences of osteoporosis and fracture, this is of great     concern. This study of the effects of gastric bypass on calcium metabolism and the skeleton     may positively impact the clinical care of gastric bypass patients by their surgeons, primary     care providers, and endocrinologists. Further, the knowledge gained may inform future     investigation into the relationships between obesity, weight loss, and bone biology.   "
149223|NCT01330901|"     This study is aimed at investigation of efficacy and safety of ustekinumab (monoclonal     antibody against interleukin 12 and 23) treatment in patients with active ankylosing     spondylitis (AS) fulfilling the modified New York criteria who have had an inadequate     response to standard therapy with non-steroidal anti-inflammatory drugs (NSAIDs) or do not     tolerate or have a contraindication for NSAIDs.   "
149224|NCT01330888|"     The purpose of this 2-year pilot study is to explore the impact of deployment on the     psychosocial and health characteristics and reintegration of Military Chaplains, specifically     those of the Army National Guard (ARNG). This pilot will serve as the foundation for     subsequent investigations of chaplains from multiple branches of the military. In addition to     spiritual and religious support, Military Chaplains play a key role in the behavioral health     of deployed service-members, routinely participating in suicide prevention training,     conducting critical event debriefing, and identifying service-members at risk for combat and     operational stress reactions1. A high risk group for exposure to trauma2, Military Chaplains     have suffered brain injuries, gunshot wounds and blast injuries in OEF/OIF Theater3. In     addition, many report combat related stress issues such as compassion fatigue, PTSD, and     reintegration issues3. While the traumatic experiences of OEF/OIF deployed troops have been     well documented, the effects on military chaplains caring for these service-members have     received little attention in the research to date. We are collaborating with the National     Guard Chaplain Corps Leadership on this program of research. The aims of this 2-year pilot     cross-sectional study focus on describing and exploring deployment and its impact on     psychosocial, health characteristics and reintegration of ARNG chaplains using a mixed method     approach (web-based survey, in-depth interviews, social network analysis).   "
149225|NCT01330875|"     Questionnaire for patients who got a lumbar infiltration in our clinic. The patients will     have to answer questions concerning their pain. (The lumbar infiltration itself is not part     of this study)   "
149226|NCT01330862|"     The study is to provide accurate, reliable information on NSCLC clinical management across     MENA (Middle East North Africa) countries in order to detect unmet medical needs of this     disease, it is a purely observational study; therefore patients are not assigned to a     particular therapeutic strategy beforehand by a protocol. Treatment will be according to     current clinical practice.   "
149227|NCT01330849|"     The purpose of this study is to examine the efficacy of the ADHD-Toolkit (a toolkit for     school behaviour modification in primary school children with ADHD-behaviours) in terms of     general improvement in ADHD symptoms, specific targeted school-related problem behaviours,     other disruptive behaviour disorder symptoms, teacher attitudes towards ADHD, teacher-child     relationship and child self-esteem.   "
149228|NCT01330823|"     The study investigated the role of L-Carnitine supplementation on proinflammatory immune     response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable     pancreatic cancer, UICC Stage IV .   "
149229|NCT01330810|"     Each year, there are about 150,000 new colorectal cancer (CRC) cases and 50,000 CRC deaths in     the United States. A safe and effective preventive agent could reduce the burden of     colorectal cancer as well as reduce the costs associated with screening patients who are at     high risk of developing CRC. Preclinical studies strongly suggest that curcumin is active     against multiple pathways implicated in tumor initiation, progression, and metastasis.     However, little is know how curcumin performs in humans. The investigators propose to enroll     12 healthy volunteers who will undergo blood draw and rectal biopsy after 7 days of curcumin     administration. The investigators will look at curcumin preparations with low and high oral     bioavailability and calculate the blood and rectal tissue concentrations associated with     these two formulations to determine which preparation produces the highest tissue     concentrations.   "
149230|NCT01330797|"     Purpose To evaluate the cataractogenic effect of intravitreal ranibizumab with the use of     Lens Opacity Classification System III (LOCS III).      Settings Cases with a diagnosis of wet AMD were included in this university practice based     prospective study.      Methods All cases had monthly injections of intravitreal ranibizumab in the first 3 months;     subsequently an OCT-guided pro re nata injection regimen has been adopted. All cases had a     comprehensive eye examination and LOCS III evaluation at baseline and 1, 3, 6 and 12 months     after the initial injection. Examination outcomes and change from baseline in LOCS III grades     at 12 months were recorded.      Results Eighteen eyes of 13 cases (7 female, 6 male) were included in this study. The mean     age at the baseline was 75,3 + 6,6 years. A mean of 3,4 + 0,7 injections were given on each     eye. Mean follow-up was 13,83 + 2,33 months. Baseline mean visual acuity improved from 1,04 +     0,10 logMAR units to 0,76 + 0,26 logMAR units after 3 injections (P < 0.05). At the 12th     month of follow-up mean visual acuity was 0,71 + 0,27 logMAR units. According to LOCS III     grades none of the cases had a prominent change in nuclear color, nuclear opalescence,     cortical and posterior subcapsular opacification throughout the follow-up. IOP remained     stable at all follow-up points. No complications were recorded throughout the study.      Conclusion Intravitreal ranibizumab is an efficient treatment in wet AMD. Results of LOCS III     assessments in this pilot study suggest that intravitreal ranibizumab has no effect on the     progression of lens opacity.   "
149231|NCT01330784|"     To assess the effectiveness of a protocol of ovarian hyperstimulation with urinary     gonadotrophins, to achieve clinical pregnancy in females undergoing IVF.      Study hypothesis: to assess the effectiveness of a protocol of urinary gonadotrophins   "
149232|NCT01330771|"     To assess the effectiveness of a protocol of ovarian hyperstimulation combining urinary     gonadotrophins + recombinant gonadotrophins, to achieve clinical pregnancy in females     undergoing IVF.      Study hypothesis: to assess the effectiveness of protocols combining urinary gonadotrophins +     recombinant gonadotrophins   "
149233|NCT01330758|"     A study to compare two different tablet formulations of AZD8931 in healthy males and females.   "
149234|NCT01330745|"     The purpose of this study is to determine whether cardiopulmonary bypass affects mesenteric     microcirculatory function, using sublingual evaluation, in cardiac surgery.   "
149235|NCT01330732|"     The purpose of this study is to evaluate the accuracy of SPINESCAN® with standard lateral     x-rays of the spine in patients monitored for kyphosis.   "
149238|NCT01330693|"     The purpose of this study is to find out if children with attention-deficit, hyperactivity     disorder (ADHD) have a difference in how their brain cells fire or react. The investigators     also want to find if brain cell firing can tell us how severe of symptoms a child has from     ADHD. Finally, the investigators want to see if giving an ADHD medication called atomoxetine     can make the ADHD symptoms in a child better and if the improvement shows a change in brain     firing.   "
149240|NCT01330667|"     The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively     breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3     mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for     Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc     extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or     to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to     assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is     that limited, small amounts of formula administered without a bottle immediately following     breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at     increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.   "
149241|NCT01330654|"     Beta blockers have been shown to decrease the risk of intraoperative cardiac events in     patients at high cardiac risk. However, they have also been associated with side effects (for     instance, stroke.) The role of beta blockers in patients at intermediate cardiac risk     undergoing surgery is controversial. Heart rate variability is a way of evaluating the     cardiac function of a patient. Decreased heart rate variability is associated with early     cardiac death in patients with congestive heart failure (CHF) and after a heart attack. It     has been shown to transiently decrease in patients in hemorrhagic shock after trauma and     returns to normal after resuscitation in trauma and burn patients. The investigators     hypothesize that beta blockers will maintain pre operative heart rate variability in patients     with intermediate risk of cardiac events during operative intervention with laparoscopic     surgery.   "
149772|NCT01323621|"     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI     100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily     over a 12-week treatment period in subjects with COPD.   "
149246|NCT01330589|"     The purpose of this study is to evaluate whether patients post PCI receiving clopidogrel who     are carriers of at least one CYP 2C19 loss-of-function allele may achieve improved     pharmacodynamic efficacy of clopidogrel when treated with the CYP 2C19 enzyme inducing agent,     St. John's wort, as compared with placebo.      Hypothesis        1. Reduced platelet reactivity is present in patients receiving St. John's wort as compared          to placebo when utilized in combination with clopidogrel        2. The combination or St. John's wort and clopidogrel results in enhanced platelet          inhibition   "
149247|NCT01330576|"     Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical     illness in neonates with severe necrotizing enterocolitis.   "
149248|NCT01330563|"     The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic     characteristics of CKD-501 in healthy subject.   "
149249|NCT01330550|"     The increase in diabetic population of the world is among the top ten causes of death; with     diabetes always high on the list of causes of death. Diabetes is always relative to other     major causes of death, (e.g. in cerebral vascular disease, cardiovascular disease and renal     disease).      The eating habits and patterns of the diabetic patient are the main causes for poor glycemic     control. In epidemiological studies, high fiber and low sugar dietary intake can     significantly reduce the incidence of diabetes.      The purpose of this study is to investigate the effect of high fiber sugar-free biscuits in     regulating blood glucose in pre-diabetic subjects.      The study will be conducted in three periods:      Period-I:      The recruitment of 60 pre-diabetic subjects:      Subjects of blood glucose levels Impaired fasting glucose; IFG: fasting blood glucose ≧ 100     mg / dL, < 126 mg / dL or Impaired glucose tolerance; IGT: 2 hours postprandial blood     glucose ≧ 140mg/dL, < 200 mg/dL or clinically judged to be mild or moderate diabetes mellitus     (HbA1c < 9%).      In addition to perform pre-test, all subjects also need to complete nutrition counseling and     nutrition education .      All 60 subjects are randomly selected into two groups, Group-1,30 subjects, (Placebo group,     normal fiber and normal sugar biscuit group), Group-2, 30 subjects, (Experimental group, high     fiber and sugar free biscuit group)      The period-II:      Duration: 8 weeks Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit     group) , All 30 subjects consume 3 servings of Low-fiber, normal sugar biscuits daily.      Group-2, 30 subjects, (Experimental group, high fiber and sugar free biscuit group) All 30     subjects consume 3 serving of high-fiber, and sugar free biscuits (containing 16 grams of     fiber) daily.      Post-period:      Blood samples of all 60 subjects will be collected to compare with period-I and period-II at     the first day of 9th week.      Report of expectation:      The purpose of this study is to help the pre-diabetic subjects to reduce the risk of becoming     diabetic through the consuming of high fiber and sugar free biscuits and nutrition education.   "
149250|NCT01330537|"     The topological perception theory proposed a precise description for how one organizes the     visual world that eliminates the vagueness of subjective phenomenology. In addition, the     topological theory challenges the dominant computational view on the part-to-whole hierarchy     of visual information processing. Lines of evidence from adult psychophysics, brain imaging     data, and even honeybee's behavior have supported the notion that the global topological     properties are the very primitives of visual representation. However, the question of how the     sensitivity to topological properties originates during development has not been explored     much. In a previous study, the investigators found that 2- to 6 month old infants could     reliably discriminate stimuli based on topological differences, but failed to do so based on     geometric differences. Using familiarization/novelty preference procedure, the present study     intends to explore the visual sensitivity for topological properties in newborn infants.     Experiment 1 focuses on whether neonates can discriminate a disk (no hole) and a ring (with a     hole) that are topologically different, and/or a disk (no hole) and a triangle (no hole) that     are geometrically different. Experiment 2 focuses on whether neonates can detect a change in     the number of holes and/or the size of the hole. If newborn infants are only sensitive to     topological properties and not to geometric properties, this will be a strong proof for the     claim that topological property is the very primitive visual representation at empirical as     well as theoretical level.   "
149251|NCT01330524|"     In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic     Neuropathy(NSION) who had a sudden mono ocular vision loss associated with optic disc edema     and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly divided     in two groups 1) control 2) case. In case group Avastin and Triamcinolone will be injected     trough vitreal and placebo will be injected in control group. BCVA and Visual field will be     then measured in these two groups.   "
149252|NCT01330511|"     Patients with congenital hydronephrosis will be identified by inpatient consultations     performed by Dr. Assadi for congenital hydronephrosis and by outpatient problem lists with     congenital hydronephrosis of Dr. Assadi's existing patients. Given standard evaluation will     be evaluated to determine if based on initial ultrasound classification an algorithm can be     developed to target evaluation studies for the initial evaluation. With a goal of targeting     the few children that have need of additional intervention and minimizing the studies     performed on children who will spontaneously resolve.   "
149268|NCT01330303|"     It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments,     02 sequences, and 02 periods, in which the volunteers receive, in each period, the test     formulation or the reference formulation, under fed conditions.   "
149253|NCT01330498|"     This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed     to assess the longitudinal pharmacokinetic, pharmacodynamic, immunological, and biochemical     sample collection with MRI and relapse analysis of a Tysabri patient cohort. The study hopes     to identify secondary and tertiary risk stratification markers that would aid in the clinical     management of patients who are JC antibody positive.   "
149254|NCT01330485|"     Nested within a longitudinal study investigating emotion regulation skills and subsequent     depressive symptoms in major depressive disorder, the effectiveness of a systematic affect     regulation training (ART; Berking, 2010) is evaluated in a randomized controlled trial.   "
149255|NCT01330472|"     Study to evaluate if Xanax sustained release tablets manufactured at two different sites     provide similar drug levels in the blood.   "
149256|NCT01330459|"     The purpose of this study is to determine whether preoperatively administered     hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.   "
149257|NCT01330446|"     The goal of this clinical research study is to learn if armodafinil can reduce fatigue and     other common symptoms in patients that have received treatment for head and neck cancer.   "
149258|NCT01330433|"     This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the     effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on     the formation of mediastinal and pericardial adhesions in children undergoing staged surgical     reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn     Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated     by drainage post-operatively through surgical site drainage output.   "
149325|NCT01329523|"     The purpose of this study is to determine if insulin-like growth factors (IGF) play a role in     the development of dementia, specifically Alzheimer's disease (AD). The study will compare     results from genetic testing between patients with AD and two other groups: younger     biological family members of the AD patients and individuals without AD matched by age to the     AD patients.   "
149259|NCT01330420|"     The linkage between the Massachusetts General Hospital (MGH)-Community Health Associates and     the MGH-Benson Henry Institute for Mind-Body Medicine began in order to address the concern     of providing affordable, easily accessible, culturally appropriate behavioral medicine     interventions for low income patients served by MGH Community Health Centers, as well as the     desire to demonstrate the efficacy and economics of these interventions. Since depression was     such a prevalent issue among health center patients, with a significant impact on health care     service utilization, it was decided to focus on offering Mind/Body services to this     population first.   "
149260|NCT01330407|"     The investigators intend to conduct a comparative, monocentric prospective double-blind study     with intra-subject randomization, to compare the results on wound healing of 2 adjuvant     treatments to Meek micrografting technique : Cultured Epidermal Autografts and cryopreserved     skin allografts.   "
149261|NCT01330394|"     Alcohol dependency is the most frequent addiction leading to a massive burden of both,     patients health, and economy. Present therapeutic concepts suffer from limited efficacy, and     thus new innovative therapies are needed. Neuroscientific studies have shown that prefrontal     function in alcohol-dependent patients is impaired, leading to cognitive disturbances, and     continuation of dependent behaviour. The results of pilot studies demonstrate that activation     of prefrontal cortices via non-invasive brain stimulation improves cognitive performance in     healthy subjects, and diminishes dependency-related behaviour in patients. The investigators     aim to develop a stimulation protocol suited to induce a clinically relevant improvement of     prefrontal functions in patients suffering from alcohol dependency. Therefore, the     investigators will develop stimulation protocols which are able to modulate prefrontal     activation for a much longer time course than those currently available, and will explore if     the induced physiological alterations translate to respective cognitive improvements and     reduction of addictive behaviour.   "
149262|NCT01330381|"     To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional     constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label     comparator (PEG) controlled part will follow, to document safety and tolerability up to 24     weeks.   "
149263|NCT01330368|"     The purpose of this study is to compare healthy children to children who have systemic lupus     erythematosus (SLE). SLE is a childhood disease that has high risk for low bone mass and     vertebral compression fractures.   "
149264|NCT01330355|"     The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin     0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when     administered three times daily (TID) for seven days to neonatal subjects who are 31 days or     younger on the day of randomization (Visit 1).   "
149265|NCT01330342|"     The study's chief objective is to observe the evolution of cellular (in terms of expression     of transmembrane transporters and their transcriptional regulators) and viral resistance (in     terms of development of mutations in the HIV genome that may confer resistance to future     treatment for HIV) in HIV-infected patients with lymphoma.   "
149266|NCT01330329|"     The purpose of this study is to evaluate the effectiveness of a technology-based system (the     Body Media FIT system) for enhancing weight loss in severely obese individuals (BMI: ≥ 40     kg/m2). The investigators will compare two 6-month interventions: 1) a standard behavioral     weight loss program (SBT) and 2) a standard behavioral weight loss program plus the use of     the Body Media FIT system (SBT+FIT). The Body Media® FIT system is a novel weight loss tool     consisting of an armband that measures energy expenditure, a digital display watch that     provides real time physical activity and energy expenditure feedback, and access to a     system website which allows individuals to track their food intake and set exercise and     dietary goals. We will examine differences in physical activity, weight loss, and program     adherence between groups.   "
149267|NCT01330316|"     The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of     treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon     (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from     PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.   "
149270|NCT01330277|"     Hunter Syndrome (mucopolysaccharidosis II [MPS II]) is a lysosomal storage disorder caused by     reduction or absence of the iduronate-2-sulphatase enzyme has still the problem of the     difficulties of a simple and reliable analysis for the primary diagnosis but also for the     follow-up of the disease. Especially in the cases of female carriers which have been reported     to have some symptoms of MPS II due to skewed X-inactivation makes the diagnosis complex.     However, early diagnosis and treatment of disease complications with enzyme replacement     therapy can improve quality of life.Therefore the primary aim of our project called BioHunt     is the development of a new plasma biomarker for the early and sensitive diagnosis of the     disease. The secondary aim is the testing for clinical robustness, specificity and long-term     stability of the biomarker.Within the scope of the study the investigators would like to     collect in the next 12 months from about 80 patient's plasma and in parallel a simple     documentation of the clinical data.   "
149271|NCT01330264|"     The SIM City study seeks to explore for the variance in practice that is associated with     nursing and medical care of patients with brain pressure (ICP) monitors. The underlying     hypothesis is that there is not a consistent pattern of care throughout the U.S., rather,     there is a wide range of practice patterns that are used to monitor and treat ICP.   "
149288|NCT01330004|"     Hyper- and hypotension are important predictors of survival in non-ESRD (end stage renal     disease) population. In dialysis patients, however, it has been shown that higher blood     pressure levels may actually be beneficial to patient outcomes. Dynamics of blood pressure     evolution over time has not been previously studied in dialysis population. The investigators     aim to understand how both blood pressure levels and blood pressure changes over time predict     patient survival.   "
149272|NCT01330251|"     This study will investigate the effects of gastric bypass surgery on type II diabetes. The     study will recruit patients with type II diabetes having Roux-en-Y gastric bypass, patients     without type II diabetes having Roux-en-Y gastric bypass, and control subjects (patients     having gastroscopy, but no surgery). Targeted enrollment is 30 patients per group. Samples of     intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after     surgery during gastroscopy. Meal test with incretin measurements, and feces and blood     samplings are performed before and after surgery      Hypotheses are:        -  The pathogenesis of type II diabetes is linked to changes in the expression of          intestinal endocrine cells        -  The changes in the incretine excretion after the gastric bypass surgery partly explain          the amelioration of type II diabetes        -  The oxidation of lipoprotein is diminished after the gastric bypass surgery slowing the          development of atherosclerosis        -  The immunologic functions of the intestine are changed by the gastric bypass surgery          attenuating systemic inflammation        -  The gastric bypass surgery changes cholesterol and bile acid metabolism        -  The gastric bypass surgery changes the fecal microbiota      Primary end points are:        -  Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum        -  Changes in the incretine secretion studied with liquid meal test        -  Changes in the oxidation of lipoproteins        -  Changes in the immunologic markers in ventricle, duodenum and jejunum        -  Changes in the amounts of phytosterols, cholesterol metabolites and bile acids        -  Changes in fecal microbiota   "
149273|NCT01330238|"     Modic changes are associated with low back pain (LBP) both in clinical and general     population-based samples. Type I changes are regarded as more likely to be painful than type     II changes. Several studies suggest that type I changes are inflammatory in nature.   "
149274|NCT01330199|"     The purpose of this study is to develop a predictive antiretroviral pharmacokinetic model of     mucosal fluid and tissue distribution in genital tract fluid, rectal fluid and 3 mucosal     tissues. This will be accomplished by determining the pharmacokinetic disposition and dose     proportionality of four antiretrovirals (tenofovir, emtricitabine, maraviroc, and     raltegravir) in human rectal and cervicovaginal fluid and rectal, cervical, and vaginal     tissue.   "
149275|NCT01330186|"     The purpose of the study is to evaluate the predictive value of 18F-fluoromisonidazol-PET     (FMISO-PET), 2-18F-fluoro-2-deoxy-d-glukose-PET-CT (FDG-PET-CT), Diffusion-Weighted Magnetic     Resonance Imaging (DWI-MRI) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging     (DCE-MRI) for patients with anal cancer receiving radiation therapy +/- chemotherapy     (Cisplatin and 5-FU).   "
149276|NCT01330173|"     This phase I trial studies how well vismodegib after stem cell transplant works in treating     patients with high-risk first remission or relapsed multiple myeloma. Vismodegib may slow the     growth of cancer cells. Giving vismodegib after autologous stem cell transplant may kill more     multiple myeloma cells.   "
149277|NCT01330160|"     If the risk of dementia occurrence after stroke is well known, few data exist about the     factors influencing positively or negatively the developement of cognitive disorders or     dementia. The aim of the study is so to determine prospectively the clinical, biological,     lesional and pharmacological factors associated with post-stroke dementia by the long-term     follow-up of a stroke patient cohort.   "
149278|NCT01330147|"     The principal aim of this study is to provide vital current data on the prevalence,     distribution and natural history of Human Papilloma Virus (HPV) infection in the mouth. This     data is an essential requirement for the assessment, development and evaluation of cost     effectiveness of prophylactic vaccination and screening programmes.   "
149279|NCT01330134|"     The objective of our study is to determine if technique of lidocaine administration can     decrease pain perception.      Hypothesis: There will be a significant difference in pain perception between patients who     are given lidocaine on the skin surface prior to subcutaneous injection and patients who are     given only subcutaneous injection by standard approach.   "
149280|NCT01330121|"     The purpose of the study is to evaluate patient adherence with discharge diabetes medications     up to 120 days following pharmacist counseling during hospital stay about diabetes self     management   "
149281|NCT01330108|"     The primary objective of this study is to assess the safety and tolerance of changing     patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial     hypertension.   "
149282|NCT01330095|"     To evaluate the effects of early administration of probiotics on acceleration of enteral     feeding, and on growth of very low birth weight infants, newborn infants with birth weight     less than 1500g are administered Bifidobacterium bifidum twice a day.   "
149284|NCT01330056|"     This is a prospective randomized controlled trial comparing functional organ preservation     surgery (FOPS) vs. radiotherapy or chemoradiotherapy as the first treatment modality for     patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and     hypopharynx. This study has a hypothesis that the FOPS is an effective treatment strategy to     preserve the organ function without compromising oncologic safety and survival.   "
149285|NCT01330043|"     Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and     Santa Clara counties will serve as the target population for this study. A total of 400     smokers meeting eligibility criteria will be randomized. Treatment will include both open     label and extended treatment phases. Randomization. Participants will be randomized to     extended therapy or control conditions at baseline (prior to open label treatment) and the     analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary     hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher     prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the     Supportive therapy Control treatment.   "
149286|NCT01330030|"     Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of     this study is examine whether selegiline, given in the form of a skin patch, is effective in     stopping smoking.   "
149287|NCT01330017|"     The trial will evaluate the nasal congestion symptom relief of the approved 10 mg     phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo     in participants with histories of seasonal allergic rhinitis, using loratadine as background     medication.   "
149291|NCT01329965|"     The purpose of this study is to establish the safety and feasibility of low dose LPS     administration to a small subset of humans in preparation for a larger USDA funded study     examining what is the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day     delivered as fish oil supplements) that significantly attenuates the inflammatory response     the investigators wish to examine the effects of an endotoxemia model for inducing     inflammation. Based on previous research, low dose LPS administration affects metabolism in     humans with only minimal clinical effects (such as flu like illness). Therefore, each of     the six subjects included in this small pilot study will receive a low dose of LPS and     placebo in order to learn more about the metabolic changes that occur during administration     and inflammation. The investigators hypothesis that LPS administration will elicit only     minimal clinical effects (such as flu like illness) when compared to placebo (saline--water     with the same amount of salt as in your blood).   "
149292|NCT01329952|"     The investigators will identify possible participants using our database of previously     treated hepatitis c patients. The investigators will identify those who have documented     evidence of current injecting drug use as a risk factor for acquisition of the virus. The     investigators will then search for those who have received curative treatment between     2004-2010. This covers all patients in the current database. The investigators will include     those over 18 years old. The investigators will exclude those patients who are coinfected     with either hepatitis B or HIV. This is because both of these conditions can accelerate liver     damage when in combination with hepatitis c.      The possible participants identified will be sent an information sheet giving a simple and     clear outline of the proposed research. The investigator will try to obtain an au to date     residential address from the PAS system in the NHS or through confirmation from the patients     GP or drug worker. It will explain the purpose of the study, why they have been chosen, what     taking part will involve, the potential advantages and disadvantages of taking part and that     everything will be kept confidential. It will also outline who is conducting the study, how     any expenses will be paid and contact details for any problems/complaints that arise.      Those interested in taking part will attend an appointment at the hospital after they have     had the opportunity to read through the information leaflet. They will be given time to ask     any questions they have about the study and have them answered fully. They will then be asked     to sign two copies of a consent form in order to take their participation any further. Once     this is complete they can have their first 'liver assessment'. The assessment will take     approximately 30-45 minutes to complete.      The investigators will take three blood samples from them (approximately 10mls of blood or 4     teaspoons full). One sample is to measure the levels of hepatitis C virus in the blood. This     will tell us whether there has been reinfection with hepatitis C. The second sample is to     measure the levels of inflammation within the liver and the third sample is to measure the     full blood count. The investigators will then perform a liver scan called a fibroscan. This     is a noninvasive test similar to an ultrasound (that pregnant women have) and gives a reading     that can tell us about any 'stiffness' in the liver. It takes approximately five to ten     minutes to complete and involves the patient lying on their back with their right arm above     their head for the duration of the scan. Following the scan the investigators will ask the     participant to complete a short questionnaire. This will include questions about past and     current drug use as well as any alcohol use. The answers will be kept strictly confidential.     They will be stored in the researchers locked office and have no direct participant     identifiers on them. They will simply have a study number on them.The participant will then     be thanked for their time and offered £30 to cover all travel and time expenses for their     visit.      They will be invited to attend for a further liver assessment one year after their first one     and annually thereafter. This is optional and they are of course free to withdraw from the     study at any time without needing to give a reason.      The investigators will be identifying participants at different points in time following     their curative treatment. For example some will have been cured 5 year ago whereas other will     have been cured 6-12 months ago. This will increase the number of patient years follow up.     Once the investigators have done the first set of liver assessment the participants will then     be followed prospectively for as long as they wish to participate.      For the purpose of my higher degree I will present the data I have following two years of     'liver assessments'.   "
149293|NCT01329939|"     Background: In recent years, the prevalence of both asthma and obesity has risen dramatically     among children and adolescents in the United States. Given the concurrent rise in the two     epidemics, there may be an underlying link. Obesity contributes to asthma severity and     control, and may play a role in its underlying cause. Obesity is associated with a state of     heightened inflammation that may lead to an increase asthma symptoms and severity. Obese     adult patients treated with montelukast, an anti-inflammatory agent, seemed to have better     asthma control than those treated with other standard asthma medications. The use of     montelukast in obese children and adolescents has not been specifically studied.      Hypotheses and Specific Aims: The use of montelukast will improve asthma symptoms and     objective markers of asthma to a greater degree in obese, as opposed to non-obese children     and adolescents. The investigators would like to determine if the use of montelukast will     improve objective asthma scores, pulmonary function, markers of inflammation and medication     use to a greater degree in obese as opposed to non-obese children/adolescents.      Potential Impact: Given the growing epidemic of obesity-associated asthma in the U.S., a     tailored approach focused on obese asthmatic children may help reduce the burden of this     disease, health care costs and potential long-term complications as these children enter     adulthood. Furthermore, this study may help clarify the underlying mechanisms that link     asthma and obesity. Although this proposal is focused on one medication, it provides an     example of how certain medications may have differential efficacy in the obese asthmatic.   "
149294|NCT01329926|"     The aim of this study is to develop and optimize methods to isolate, propagate and     differentiate adult human neural stem cells from patients with degenerative neurological     disorders like Parkinson's disease.   "
149295|NCT01329913|"     This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in     HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected     participants who will be randomized to receive either MK-6325 or placebo. If the drug is     shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected     participants who will be randomized to receive either MK-6325 or placebo.   "
149296|NCT01329900|"     The goal of this clinical research study is to learn if it is possible to collect stem cells     after ofatumumab and chemotherapy treatment. This study will also evaluate side-effects,     number of stem cells collected, and the number of procedures that are needed to collect     enough stem cells.   "
149297|NCT01329887|"     This study is an evaluation of the effect of ketanserine on sublingual microcirculation in     intensive care patients with severe sepsis.   "
149298|NCT01329874|"     The purpose of this study is to determine whether Gow Gates block injection is more effective     than conventional alveolar nerve block in anesthetising mandibular molars with acute     pulpitis.   "
149299|NCT01329861|"     The aim of this study was to investigate whether an Internet-based cognitive behavioural     intervention would have an effect on the symptoms of chronic back pain.   "
149300|NCT01329848|"     This project will develop clinically useful, objective measurements of accommodative     insufficiency and fatigue using continuous autorefraction recordings. The development of     these procedures will help vision care professionals diagnose and treat accommodative     anomalies.   "
149310|NCT01329718|"     Epigenomics has identified methylated gene regions that are specific for colorectal cancer     (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified     as a particularly robust methylation marker for detection of CRC. Epigenomics is currently     developing a blood based CRC screening test based on Septin 9 and is performing a large     prospective clinical trial showing its clinical utility in a population at average risk for     CRC. Parallel to this trial further activities are needed to evaluate, optimize, and develop     pre-analytical and analytical workflows as well as molecular assays making possible the use     of Septin 9 methylation in the clinical routine.   "
149301|NCT01329835|"     Prepregnancy obesity, defined as a body mass index (BMI) of 30kg/m² or more, shows a strong     association with pregnancy and birth complications for both the mother and her child. Most     consequently reported maternal risks include an increased risk for gestational diabetes,     hypertension and pre-eclampsia, increased incidence of induction of labour, operative     delivery, postpartum haemorrhage, anaesthetic risks as well as risk for infections and     thromboembolic complications. Fetal risks include miscarriage, neural-tube defects, heart     defects, macrosomia and stillbirth. Initiation and continuation of breastfeeding is more     complicated in obese women than in normal weight women. Also in later life chronic diseases     can put the mother and her baby's health at risk. The Institute Of Medicine (IOM) guidelines     suggest a gestational weight gain (GWG) to be limited to 5 - 9 kg (11-19,8 lb) in obese women     in order to minimize the synergetic negative health consequences of excessive weight gain for     both the obese mother and her child. Preventing excessive weight gain during pregnancy and     postpartum weight retention is also important in the prevention of overweight and obesity     among women of reproductive age. Obese women in general have a poor diet quality and are more     exposed to psychosocial factors like anxiety and feelings of depression than normal weight     women.      The aim of this project is to perform a randomized controlled trial (RCT) in order to     evaluate the effects of life-style intervention (psycho-education by a midwife during 4     prenatal sessions) on pregnancy and birth outcomes. Main dependent variables are gestational     weight gain and anxiety and depression. Obesity is a modifiable risk factor and optimizing an     adequate gestational weight gain with attention to psycho-social factors, can reduce the need     for adverse perinatal outcomes.   "
149302|NCT01329822|"     The aim of this randomized controlled study was to evaluate the effects of CR on circulating     fetuin-A levels in obese humans with type 2 diabetes based on monitoring energy intake and     energy expenditure by daily activity. Furthermore, the investigators examined the     relationship between the changes of fetuin-A levels induced by CR and cardiovascular risk     parameters including atherogenic lipid profile, visceral fat area (VFA), brachial artery     endothelial function, and carotid IMT.   "
149303|NCT01329809|"     This is a neoadjuvant Phase 2a, open-label trial in patients with metastatic colorectal     carcinoma who are undergoing a complete resection of the metastatic colorectal tumors in     their liver.   "
149326|NCT01329510|"     This study will investigate the effects of methylphenidate on sleep in adults with Attention     Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters.   "
149483|NCT01327417|"     The purpose of the study is to examine the relationship between brain structure and     depression in adults aged 60 or older. This relationship is determined using magnetic     resonance imaging technology (MRI), a scanner with a magnet that is used to create images of     the brain.   "
149304|NCT01329796|"     Endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. An     altered immune system with elevated levels of cytokines in the peritoneal fluid as well as     increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in     endometriosis patients. Lignocaine has anti-inflammatory properties and exerts effect on     nerve endings and intra peritoneal macrophages. Pertubation with lignocaine might represent     an alternative treatment for endometriosis related dysmenorrhea and avoids the side-effects     related to hormonal treatments. A double blind randomized clinical trial, was carried out to     evaluate pertubation with lignocaine as a therapy for dysmenorrhea.   "
149305|NCT01329783|"     Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the     maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral     Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort.     The rates of specific clinical adverse events in this identified patient population will be     compared with the rates of these events in the participants of the MOTIVATE trials.   "
149306|NCT01329770|"     The Fragile X syndrome (FXS) was first described by Dr. Martin and Dr. Bell in 1943, in     families with several patients affected by sex-linked mental disability. This disorder is the     most common cause of inherited mental disability. The prevalence of the Fragile X syndrome     has been established at 1 in 2,500 males and 1 in 4000 females.      Despite moderate to severe mental retardation, fragile X patients exhibit macroorchidism, an     elongated face, long ears, connective tissue dysplasia, hyperactivity, autistic-like and     stereotypical behaviours, speech delay and increased sensory sensitivity.      Objective: To evaluate the effect of the combination of the antioxidant Ascorbic acid and     tocopherol, as therapy of the Fragile X Syndrome in young males.      Hypothesis: It is proposed that part of the pathophysiology of the central nervous system in     the animal model of the fragile X syndrome may be determined by oxidative stress. In     addition, Fragile X patients showed a significantly low level of ascorbic acid in plasma. The     biochemical characteristics of oxidative stress may be reversed in the FMR1-KO mice, by a     chronic treatment with antioxidant compounds such as tocopherol or melatonin, it may also     normalize several hallmarks of the Syndrome such as hyperactivity, anxiety and cognitive     deficits. The normalization of the oxidative stress is proposed as a new therapeutic pathway     to alleviate conditions caused by an excess of free radicals that are crucial in     neurodevelopmental diseases such as autism, down syndrome and other diseases of the central     nervous system.   "
149307|NCT01329757|"     Objectives: To evaluate the efficacy and safety of one year treatment based on daily doses of     exogenous growth hormone (GH) in patients with traumatic spinal cord injury. The first six     months the pharmacological treatment will be associated to rehabilitation treatment.      The main hypothesis is that GH can improve motor function of patients with traumatic spinal     cord injury below the lesion level. The hypothesis is based on possible effects of GH at     muscle and synaptic level. GH can also promote axonal growth and regeneration.      Design: Clinical trial placebo-controlled, double-blind intervention with blind evaluation by     third parties and blinding in the analysis of data (triple-blind design).      Duration of intervention and monitoring: 364 days.      Primary outcome measures. Changes of the American Spinal Injury Association (ASIA) scale     (motor score)   "
149308|NCT01329744|"     This study examines the effects of recombinant insulin like growth factor - I on body     composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of     metabolic disease.   "
149309|NCT01329731|"     The aim of this study is to monitor the effect of intraoral topical high fluoride application     on the development of white spot lesions (WSL) after orthodontic treatment with multibracket     appliances and to compare it to a placebo.   "
149311|NCT01329705|"     The purpose of this study is to examine the effectiveness of onabotulinum toxin A (BTX)     injections (tone management) and dynamic splinting (contracture reduction) for improving gait     patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury and     resultant excessive plantarflexion.   "
149312|NCT01329692|"     Purpose and objective: To identify in the early post-operative period following laparoscopic     Roux-en-Y gastric bypass patients likely to fail to progressively lose weight in expected     fashion, and to institute intervention and assess for its efficacy.      Study activities and population group: Patients identified to have poor weight loss (≤ 11%     of excess weight loss) at 1 month will be randomized into a control versus study group.     Intervention for subjects randomized to the IV arm will be by enrollment in the Back on Track     program. This is a seven-week group education, counseling, nutrition, exercise, and     journaling program of the Duke Weight Loss Surgery Center designed to help postoperative     bariatric surgery patients who are failing to progressively lose weight resume an expected     pattern of weight loss and improved overall outcome.      Data analysis and risk/safety: Data will be collected and analyzed by the identified     investigators. The goal of data analysis is to uncover any difference in the EWL of subjects     who underwent intervention for falling in the lowest EWL quartile when compared with those     who did not undergo intervention, and determine the statistical significance of any such     difference. There are no physical risks associated with this study. There is, however, the     potential risk of loss of confidentiality. Every effort will be made to keep your information     confidential.   "
149313|NCT01329679|"     Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart     rhythm in healthy subjects.      Study design: Double blind, placebo controlled, cross-over      Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no     other medical conditions.      Intervention: 5 Hour Energy or Placebo      Primary outcome: Change in office systolic blood pressure   "
150730|NCT01309958|"     This study focused on improving the quality of dental care by fostering movement of the     latest scientific advances into daily clinical practice.   "
149314|NCT01329666|"     Primary hyperparathyroidism (PHPT) is a common disease that occurs in 1 in 10,000 people     every year. In the presence of this condition, the parathyroid glands produce excessive     amounts of parathyroid hormone (PTH), which regulates calcium levels. The high levels of     parathyroid hormone remove too much calcium from bones, and then deposit the excess calcium     in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened     by excess calcium loss which weakens bone structure. Other affected organs include the     skeleton (calcium loss leads to a weakening of the skeleton), and the kidneys (high blood     calcium can lead to kidney stones).      It is now evident that the majority of patients with even mild Primary Hyperparathyroidism     are vitamin D deficient. In 2009, new international guidelines for the management of     asymptomatic PHPT direct physicians to measure 25-hydroxyvitamin D (D3 or 25-OHD) in all     patients, and to replete the reserve of vitamin D when the level is low (< 20 ng/ml).     However, no recommendations for vitamin D repletion are given, because of limited data     regarding the effects of vitamin D repletion, appropriate dosing and safety. Therefore, there     is an urgent need for data upon which to base such recommendations, as well as are data on     the effects of such treatment upon bones.      Subjects with low vitamin D3 levels will be selected for this trial. They will be given     enough vitamin D3 to raise their low blood levels from a low to a normal range. The     assessments in this study, including the quadruple label bone biopsy, will allow us to     document the short term effects of administering vitamin D3 on changes in bone.      All participants enrolled in this trial will be vitamin D3 deficient. Participants will take     an antibiotic (tetracycline) 4 times a day to mark the starting point from which bone changes     will be assessed. After 3 days of tetracycline, a 12 week course of vitamin D3 or placebo     will be initiated. Six of 7 participants will receive the study drug (active vitamin D3),     while 1 in 7 will receive a placebo (sugar pill). Ten weeks later, another 3-day course of     tetracycline will be given. At the end of 12 weeks, a bone biopsy will be done. A small piece     of bone (about the size of a pencil eraser) will be removed from the hip (iliac crest). The     bone will be analyzed to determine the effect of vitamin D3 on primary hyperparathyroidism.      There will be 4 study visits: Screening, Baseline, Week 8, and Week 12 when the bone biopsy     will be performed.      Study Procedures:      Medical and Social History      Blood tests (drawn at the study center and local Quest Lab)      24-Hour urine collection for calcium and creatinine excretion      Abdominal X-ray (to assess for kidney stones)      Transiliac crest Bone Biopsy   "
149315|NCT01329653|"     The purpose of this study is to test the hypothesis that aerobic exercise leads increased     cerebral blood volume in the dentate gyrus of the hippocampus in a sample of young and older     adults.   "
149316|NCT01329640|"     The purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of     metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced     HER2-positive breast cancer.   "
149317|NCT01329627|"     The purpose of this study is to determine whether weekly paclitaxel followed by weekly     doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor     (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.   "
149318|NCT01329614|"     The purpose of this study is to determine whether Cue Extinction Training will reduce relapse     rates in cigarette smokers using the patch to quit.   "
149319|NCT01329601|"     The study aims to detect the effect of a structured cognitive rehabilitation program, teh     stage specific intervention STACog, on cognitive performance and functional activation in     fMRI in a group of patients with mild cognitive impairment and dementia due to Alzheimer's     disease compared to a waiting group control sample. Baseline performance in cognitive tests     and fMRI will further be assessed compared to healthy control subjects.   "
149320|NCT01329588|"     In the early years of the HIV epidemic in Africa, female sex workers (FSWs) were identified     as a high-prevalence, high-incidence, core group among whom the extraordinary prevalence of     other sexually transmitted infections (STIs) facilitated transmission of the virus to their     clients, who then infected low-risk women not involved in the sex trade. In resource-poor     settings, control of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) among FSWs is     difficult. The purpose of this study is to determine whether periodical antibiotic treatment     (PAT) is effective in controlling these infections among West African FSWs.      The study is designed as a cluster-randomized double-blind placebo-controlled trial conducted     in West Africa. The study population consists of seaters FSWs who work from their homes in     well-defined areas. Clusters will be paired according to their size and demographic     characteristics of FSWs and clients. Within each pair, one cluster will be randomly allocated     to the intervention and the other to the placebo group.      At enrollment, participants will be interviewed, a pelvic examination performed, cervical     swabs obtained for NG and CT polymerase chain reaction (PCR), and current cervicitis or     vaginitis managed syndromically. Blood specimens will be obtained for HIV testing. All     participants will be given free condoms and counseled on risk reduction.      Monthly follow-up will be conducted within FSW communities, alternating with clinic visits     where cervical samples will be collected. Study drugs (azithromycin 1 g and ciprofloxacin 500     mg, and their identical placebos) will be distributed every month according to a predefined     schedule: directly-observed intake of azithromycin at months 1, 4 and 7, and ciprofloxacin at     months 2, 3, 5, 6, 8 and 9.      Data will be analyzed with SAS. The investigators will assess the time trends in NG and CT     prevalence separately in both study groups using χ2-for-trend.   "
149345|NCT01329263|"     This study will examine how menthol affects smoking when menthol smokers switch to     non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel     Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given     Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days     each. Participants will provide breath and urine samples, track cigarette usage and complete     smoking topography assessments of smoking behavior.   "
149321|NCT01329575|"     There is no single method to investigate mediastinal LN invasion. Hence, a patient may have     to undergo several tests and procedures. Noninvasive and invasive approaches are employed.     Within the invasive techniques, endoscopic ultrasonography with needle aspiration (EUS-FNA)     and endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA) are     gaining importance in mediastinal staging.5 They provide ultrasonographic images and permit     needle aspiration under direct vision for cytology specimen analysis. As more evidence is     being accumulated on these staging approaches, the number of cervical mediastinoscopies,     considered as the gold-standard for mediastinal staging, is diminishing.      Color Doppler LN characteristics with endoluminal ultrasound (US) is only mentioned in a     small number of studies and needs to be further investigated.13,14 With the good results     obtained with superficial US, it seems reasonable to believe that color Doppler     characteristics would increase accuracy in detecting malignancy of mediastinal LNs with     endoluminal US.   "
149322|NCT01329562|"     The purpose of this study is to (1) evaluate pain-free efficacy of Treximet™ following     treatment of menstrual migraine, (2) investigate levels of Calcitonin gene-related peptide     (CGRP), estrogen, cortisol, vasoactive intestinal peptide (VIP), alpha (a)-amylase,     Prostaglandin E2 (PGE2), Prostaglandin I2 (PGI2) and beta (ß)-endorphin in saliva before and     after Treximet™, (3) evaluate efficacy of Treximet™ to return to baseline levels following     treatment, and (4) correlate estrogen in saliva vs. urinary estradiol at mid-luteal, onset of     menstrually-related migraine, and after successful treatment with Treximet™.   "
149323|NCT01329549|"     This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to     treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in     patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma     or primary peritoneal cancer. Patients will be treated with BIBF 1120 together with     carboplatin and PLD in up to 6-9 repeated 28 days treatment courses until disease progression     is observed.   "
149324|NCT01329536|"     The purpose of this clinical research study is to determine if a specific genetic allele is     involved with the development of agitation in patients with late-onset Alzheimer's Disease     (AD). The study will compare the results of genetic testing between two groups: individuals     with late-onset AD who show signs of agitation and individuals with late-onset AD who do not     show signs of agitation.   "
149327|NCT01329497|"     Hyperphosphatemia is highly prevalent in PD patients, and it is an independent risk factor     for all-cause and cardiovascular mortality in these patients. Effective treatments are     limited in suppressing plasma phosphorous. Because of the nearly linear relationship between     protein and phosphorus intake, high dietary protein intake (DPI, 1.2-1.3g/kg/d recommended by     KDOQI) would load high phosphorus burden in PD patients. It is suggested that     hyperphosphatemia is hard to avoid under such a DPI level, even as the patients take     sufficient phosphorus blinders and receive high PD dosage. The present study is to     investigate whether systemic dietary instruction would show effects on control of     hyperphosphatemia in PD patients.   "
149328|NCT01329484|"     The purpose of this study is to determine whether the use of computerized systems in 2 common     non pharmacological therapies (cognitive training and reminiscence therapy) will improve the     cognitive function of patients with mild to moderate Alzheimer's disease (AD), or at least     delay its deterioration. In addition, the investigators hypothesize that using the     computerized systems will result in improved well-being of the patients and their main     caregivers / family members, and in improved patient-caregiver and patient-family relations.   "
149329|NCT01329471|"     The purpose of this study is to elucidate the role of RUNX1 in Acute Myeloid Leukemia (AML),     in particular, the transcriptional regulation of genes by mutated forms of this protein. This     research will study the effect of mutations found in AML patients   "
149330|NCT01329458|"     The aim of the study is to assess the value of contrast enhanced ultrasound in the evaluation     of de novo focal liver lesions in clinical practice, in a prospective multi-center design.   "
149331|NCT01329445|"     The purpose of this study is to evaluate the long-term outcomes of DeNovo NT, a tissue     product used for the repair of cartilage damage in the knee. This product has been on the     market since 2007 and implanted in more than 10,000 patients around the country.   "
149332|NCT01329432|"     Spontaneous breathing supported by nasal continuous positive airway pressure (nCPAP) is     thought to have some advantages compared with mechanical ventilation in premature infants. In     addition, early surfactant administration has been shown to be superior to delayed use. The     aim of this pilot study was to describe the feasibility of TAKE CARE (early administration of     surfactant in spontaneous breathing) procedure and compare its short-term and long-term     results with InSurE procedure.   "
149333|NCT01329419|"     An open label, multi-centre, non-interventional post-marketing surveillance to monitor the     safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according to     the prescribing information   "
149334|NCT01329406|"     The present study will aim to evaluate the efficacy of milnacipran in the treatment of pain     due to osteoarthritis (OA), that is, to determine whether milnacipran provides superior     efficacy to placebo in patients with OA. Milnacipran is a serotonin-norepinephrine reuptake     inhibitor (SNRI) that is currently approved in the United States in the treatment of major     depressive disorder and fibromyalgia. There is increased evidence to suggest that SNRIs may     be effective in the treatment of chronic pain conditions, such as OA.      The hypothesis in this study is that the survival time (time from randomization to loss of     efficacy) of milnacipran group is superior to that of placebo group.   "
149335|NCT01329393|"     This stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and     collect qualitative data concerning a brief money management intervention for people disabled     by psychiatric illnesses.   "
149336|NCT01329380|"     This study of Humira will be conducted to clarify the following with regard to the treatment     of ankylosing spondylitis with this drug:        -  Unknown adverse drug reactions (especially important adverse drug reactions)        -  Incidence and conditions of occurrence of adverse reactions in the clinical setting        -  Factors that may affect the safety and effectiveness of Humira   "
149346|NCT01329250|"     The main objective of this prospective clinical trial is to compare pharmacokinetics and     safety and tolerability of a standard dose (400 mg) with an escalated dose (600 mg; 800 mg)     of moxifloxacin (MFX). This clinical trial will provide important safety information on MFX     in a higher dosage in TB patients.   "
149337|NCT01329367|"     The consumption of diets enriched in proteins (legumes and fish) or antioxidant (fruits and     vegetables) could have beneficial effects beyond those of the caloric restriction on     biomarkers of the inflammatory and oxidative status. OBJECTIVE: To address the effect of a     10-week dietary intervention aimed to weight loss in obese or overweight children (7-15 aged)     on genomics, particularly the changes in the expression of genes related to the inflammatory     status and oxidative stress. METHODOLOGY: 44 Navarra children and adolescents of both sexes     from Pediatric Endocrinology Services at different Hospitals in Pamplona will be recruited.     The effect of the intensive consumption of different groups of food will be evaluated:     legumes and fish ( diets in proteins) and vegetable and fruits (rich diets in antioxidants).     Before and after the intervention, the following items will be analyzed: (1) the diet of the     subjects, (2) body composition and 3 magnitudes related to biological and development     parameters, being: (3) lipid and metabolic phenotypic profile; (4) markers of the     inflammatory status and oxidative stress, and (5) the genomic profile. The dietary programme     will be implemented both in group workshops addresseded to patients and their family, and in     individual sessions with the pediatricians and/or registered dieticians. Finally, the     programme efficacy will be evaluated by the scoreboards integrated in the 5 variables already     mentioned.   "
149338|NCT01329354|"     Nowadays, therapy with monoclonal antibodies is considered to be a standard treatment that     increases the rate of remissions and the overall survival in patients with follicular     lymphoma. Nevertheless there are an important number of patients who do not benefit from this     therapy. A way to improve the efficiency of monoclonal antibodies therapy could be to improve     the activity of the effector arm of the immune system. A strategy that has been proposed to     obtain this improvement is the utilization of lymphocyte activated killer (LAK) cells. In     addition, the combination of LAK cells with monoclonal antibodies might obtain an additive     effect across the stimulation of the antibody dependent cellular cytotoxicity (ADCC)activity.      The present clinical assay proposes to study the feasibility, safety and effectiveness of     treatment with autologous effector cells expanded ex vivo associated with a standard     maintenance treatment with rituximab in patients with follicular lymphoma in remission after     first-line treatment. In addition, we plan to analyse various biological parameters that can     predict the susceptibility of patients to treatment with rituximab. Specifically, we propose     to study the polymorphisms of Fc receptor, polymorphisms related to the ability of complement     activation, to study both the complement activity and peripheral blood cell subpopulations     that can mediate directly or indirectly dependent antibody cytotoxic effect. We will also try     to correlate any of these biological parameters with the response to treatment.   "
149339|NCT01329341|"     The purpose of this study is to evaluate use of service dogs for individuals who have been     diagnosed with Post Traumatic Stress Disorder (PTSD). Objectives include: (1) assess the     impact service dogs have on the mental health and quality of life of Veterans; (2) to provide     recommendations to the VA to serve as guidance in providing service dogs to Veterans; and (3)     To determine cost associated with total health care utilization and mental health care     utilization among Veterans with PTSD.   "
149340|NCT01329328|"     The aim of this study is to evaluate the effect of whole-body vibration in the presence or     absence of localized radiofrequency on body composition in obese female subjects. Moreover,     balance and strength tests will be performed. The study hypothesis is that whole-body     vibration induces positive changes in body composition i.e., reduction of fat mass and     increase of lean mass with associated increase in performance. The possible additive role of     radiofrequency will also be assessed.   "
149341|NCT01329315|"     This study examines the impact of tailored computer-delivered and therapist-delivered brief     motivations prevention/interventions both for adolescents who have not initiated marijuana     use (prevention), and those who use marijuana (intervention). Key moderators of     prevention/intervention effectiveness will be examined, including behavioral intentions,     self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and     potential health consequences such as STD/HIV risk behaviors. This project will provide the     critical first step toward the development and implementation of marijuana use     prevention/intervention programs that have the potential to be delivered to a large segment     of youth who seek care in our nation's primary care settings.   "
149342|NCT01329302|"     The object of this study is to determine the benefit of follicular flushing with a double     channel needle in a poor responder population for a maximum number of oocytes to be     retrieved. The investigators compare two methods of oocyte retrieval with or without     flushing. 220 patients undergoing an in vitro fertilization (IVF) or Intracytoplasmic Sperm     Injection (ICSI) have to be included. All patients with less than 5 follicles of 14 mm and     more the day of ovulation induction will be included, following a randomized protocol in two     groups, Group A: Oocyte retrieval is performed with a single lumen aspiration needle 17G.     Group B: Oocyte retrieval is performed with a double lumen aspiration needle 17G. all     follicles are flushed with flushing solution in addition to direct aspiration of the     follicular fluid, 20CC of flushing medium is provided for all the procedure and flushing     medium is collected separately from direct fluid aspiration in order to follow up each oocyte     one by one. First criterion of our comparison is the number of oocyte retrieved. Second     criteria are: oocyte quality, fertilization rate, number and quality of embryos obtained,     clinical pregnancy rate. In Group B the investigators will compare two subgroups: oocytes     collected in flush medium and oocytes from direct follicle fluid. Then the investigators will     know the capability of oocyte collected after follicular flushing to be fertilized and to     increase the success chance of pregnancy for poor responder patients.   "
149343|NCT01329289|"     The purpose of this study is to determine if adding SOM230 LAR to bortezomib and     dexamethasone is better than bortezomib and dexamethasone alone and if it should be     investigated further.   "
149344|NCT01329276|"     Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very     sensitive to detect small changes, it might be worthwhile to study the acute effect of     formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper     airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this     technique makes it possible to detect changes in airway caliber in early stages. The regional     distribution of resistance and the change in this parameter will provide more insight into     the mode of action of the product.   "
149347|NCT01329237|"     The purpose of the study is to compare strut coverage and neointimal thickness between     everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14     months after stent implantation and to determine the coronary endothelial function after     everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14     months after stent implantation by using supine bicycle exercise testing to assess coronary     vasomotor response to exercise.   "
149348|NCT01329224|"     The purpose of this study is to investigate the incidence of acetylsalicylic acid resistance     (ASA-R) among patients under chronic acetylsalicylic acid(ASA) treatment seen at our     outpatient clinic.   "
149349|NCT01329211|"     The project will involve conducting a Needs Assessment for Gastroparesis patients and their     caregivers with the goal of identifying quality of life issues associated with this disease.     Identifying these issues will ameliorate management and support systems for gastroparesis     currently existent in the community and, hopefully, provide information for the establishment     of more resources to assist the patients and their families.   "
149350|NCT01329198|"     The purpose of this trial is to determine whether a particular type of Deep Brain Stimulation     (DBS), scheduled Deep Brain stimulation (SBS), is an effective and safe treatment for     Tourettte syndrome (TS).      The trial will also examine the brain activity associated with TS and tics and explore the     possibility of responsive brain stimulation (RBS).   "
149351|NCT01329185|"     The aim of our study is to reduce viral (CMV and EBV) transmission from donor to recipient.     The discovery that anti-retroviral therapy to mothers with HIV reduced transmission of the     virus to their babies was pivotal to the prevention of AIDS and so along the same lines the     investigators will test the hypothesis that 14 days of the anti-viral Valganciclovir (VAL) to     kidney donors prior to the transplant compared to placebo will reduce EBV and CMV viremia in     the 1st year posttransplant in pediatric kidney recipients.   "
149352|NCT01329172|"     Background :      Cystic fibrosis (CF) patients are prone to recurrent pulmonary infection have different     secreted mucin pattern from healthy subjects. Long chain polyunsaturated fatty acids have     been shown to influence survival and MUC5B expression in mice model of chronic pulmonary     infection.      Method :      To study the impact of LCPUFA n-3 on MUC5B expression (mRNA level by RT-PCR) collected in     airway epithelial cells obtained by nasal brushing. The secondary aim is to assess : MUC1,     MUC2, MUC4, MUC5AC, MUC7 expression (mRNA level) in airway epithelial cells obtained by nasal     brushing; Lund-Kennedy score; TNK-alpha, IL-6, IL-8 in blood plasma. This study is a double     parallel, controlled double blind, randomized clinical trial : LCPUFA n-3 (1 g/day) vs     placebo for 6 weeks. 30 subjects will be included in this study. Primary and secondary study     end point will be assessed two times: before randomization and after 60 days of treatment.      Statistical analysis :      Treatment group and placebo will be compared using U-Mann-Whitney, intention to treat and per     protocol.   "
149353|NCT01329159|"     The aim of this study is to assess in the sample of population resident in the KHUMBU valley     (NEPAL):        1. the respiratory function decline by means of spirometry and the respiratory health by          means of questionnaire and six-minute walking distance        2. the presence of markers of early atherosclerosis with ultrasound and to estimate the          value of systolic pulmonary pressure in comparison with not exposed subjects.      The investigators hypothesize that the chronic exposure to indoor pollution        1. can accelerate the physiological respiratory function decline, usually around          15-20mL/year in healthy subjects        2. induce cardiovascular impairment           The population of high altitude villages is a unique sample to study the effect of the          only indoor pollution. In fact, the absence of traffic, due to the lack of roads, and          the very low level of smoking habits allow to have no other confounding factors        3. to study and analyze how the architectural features of the buildings of the village          (distribution of domestic locals, natural or non natural ventilation systems, domestic          activities, materials used, etc.) affect the indoor pollution from carbon monoxide,          which necessarily is developed indoor during the daily life activities.      What the project prospects is to gather information focused on the scale of the building,     independently from the typology, to study a model that will help to describe which aspects     are most important to what concern the genesis of the pollution of the indoor air.   "
149354|NCT01329146|"     Background: calculation of the pulse pressure variation (PPV) has repeatedly been shown to be     a reliable predictor of fluid responsiveness in mechanically ventilated patients. But PPV     measurement has not been yet validated in thoracic surgery during one-lung ventilation. The     modifications of intrathoracic pressure induced by one-lung ventilation may altered the     capabilities of PPV to predict fluid responsiveness.This study was designed to assess the     ability of PPV predict fluid responsiveness during one-lung ventilation in thoracic surgery.      Methods: a prospective observational study. Thirty five patients undergoing a pulmonary     resection (lobectomy or pneumonectomy) will be included to achieve around one hundred fluid     challenges with a 250 milliliters colloid solution in response to hemodynamic     instability.Hemodynamic instability is defined as a decrease by 20 % of artery pressure from     baseline and/or an increase by 20% heart rate from baseline. Fluid responsiveness is defined     as an increase in stroke volume index (SVI)>10% (measured with oesophageal doppler). PPV will     be calculated from recorded artery pressure curve (PPVref) before and after each fluid     challenge. An automated measurement of PPV proposed by the monitor Intelview (Philips) will     be recorded simultaneously before and after each fluid challenge.      Statistical analysis: receiver operating characteristic curve will be used to assess the PPV     capability to predict fluid responsiveness. Correlation analysis will be achieved using a     Pearson test or Spearman's rho test when necessary. Continuous data will compared using a     Student t test or a Mann-Whitney test when necessary.   "
149415|NCT01328340|"     We are exploring a unique weight-training program for men and women 55 years or older with     knee osteoarthritis (OA) that emphasizes high-speed movements. We believe that the speed at     which muscles move may be more important to the improvement of muscle performance, function     and pain than how strong the muscles are. We are comparing high-speed power training with     traditional strength training to determine which method has the greatest effects on muscle     strength, muscle power, speed of movement, functional performance and pain. We believe that     high-speed training will improve these measures to a greater extent than simply training for     increased muscle strength.   "
149355|NCT01329133|"     Obsessive-compulsive disorder (OCD) is a relatively common psychiatric condition, which is     classically treated by antidepressant medications in combination with psychotherapies.     However, both these conventional therapeutic approaches fail to sufficiently improve     obsessive-compulsive symptoms in 20-30% of cases. From these considerations, deep brain     stimulation (DBS), as a reversible and adjustable surgical procedure, has recently been     introduced in the field of resistant OCD. DBS currently uses electrodes with four contacts on     each lead, which are bilaterally implanted into the chosen brain structure. DBS consists of     the delivery of a high-frequency current through the quadripolar electrodes connected to a     battery powered pulse-generating device. Several clinical investigations have shown that DBS,     primarily targeting either the ventral striatum (VS) or the subthalamic nucleus (STN), as     brain sites of interest because of their particular involvement in the production of OCD     symptoms, is able to produce an approximately 40% or greater reduction in clinical symptom     intensity in severely chronic and incapacitating forms of OCD. These promising findings lead     to propose a comparison of the efficacy, safety and tolerability of DBS choosing either the     VS or STN as brain target by conducting a large controlled trial and including a     medico-economic analysis for assessing the classical cost/efficacy ratio. In this way, the     present study is expected to promote and highlight the importance of DBS, as an effective,     safe, well-tolerated and cost-relevant surgical approach for the management of resistant OCD.   "
149356|NCT01329120|"     A large number of institutions have reported their early results with minimally invasive     repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed     the outcomes relevant to the concerns of the patients and even fewer have reported long-term     results following bar removal. Even fewer studies have investigated the prevalence and     characteristics of long term persistent post-surgical pain following surgical repair of     pectus deformities. The reasons as to why acute postoperative pain in some patients persists     and becomes chronic whereas in others the pain dies down shortly after wound healing are     largely unknown, and why some patients complain of loss of sensibility in wide regions of     their chest following surgery also remains unclear.   "
149374|NCT01328886|"     The purpose of this extension study is to assess the long-term safety and tolerability of     omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with     inadequately controlled allergic asthma despite current recommended treatment by providing     continued treatment with omalizumab to patients who have previously completed the core study.   "
150900|NCT01308671|"     The purpose of this study is to investigate the effects of steady-state varenicline on the     antiplatelet action of clopidogrel in patients with coronary artery disease.   "
149357|NCT01329107|"     The incidence of bladder cancer is increasing. Denmark have approximately 1800 incidence per     year. The disease is most frequently in males above the age of 70 years. In invasive     bladdercancer surgery including removal of the seak bladder with constructing of a new     diversion, is the first line treatment. However the procedure is followed by a high morbidity     and convalescence. Extended surgical procedure cause pain, stress-induced metabolism and     impaired organ function resulting in postoperative complications impacting on rehabilitation.     The combination of extended surgery and the increasing numbers of elderly comorbid patients     with invasive bladder cancer challenge professional treatment and care      The aim of the study is to investigate the efficacy of a multiprofessional rehabilitation     programme for patients with invasive bladder cancer referred to surgery      Material and Methods The study is a randomised controlled trial. All patients > 18 years     referred to radical cystectomy will be eligible for this study. The efficacy is primary     expressed by the difference in length of stay(LOS). Secondly by complications, health related     quality of life(HRQoL) and patient reported quality of care during hospitalization. The     intervention includes precise instructions and educations in intensive pre- and     postoperatively exercises and stoma-care, supported by the multiprofessional team.      Perspective It is a national goal to improve cancer care. This study is of critical     importance and places great emphasis on the patients perspective and involvement in a     successful outcome for participant`s and involvement in nutritional support, intensive     exercises and stoma care, supported by the multidisciplinary team   "
149358|NCT01329094|"     The aim of the study was to evaluate the applicability of the Physical Activity Scale (PAS)     in relation to patients with severe mental illness. The study hypothesised that physical     activity levels among patients with severe mental illness was significantly lower than     healthy controls. The physical activity level of patients with severe mental illness     attending Aarhus University Hospital, Risskov in comparisons with healthy controls matched on     gender and age was assessed with PAS.   "
149359|NCT01329081|"     BACKGROUND In 2008 approximately 7,700 total knee arthroplasties (TKA) were performed in     Denmark. The results after TKA is in general very good, the investigators have, however,     discovered that patients following fast-track TKA still have a deficit 12 months     postoperatively of 5-10% in health-related quality-of-life and 15-20% in activity and     participation when compared to age- and gender matched population. A postoperative     rehabilitation intervention has the potential to reduce or remove this observed deficit. The     current evidence of postoperative rehabilitation after TKA is, however, scares and     conflicting, and no studies have shown a lasting effect beyond 3 months postoperatively.      PURPOSE The purpose of this study is to investigate if a 6-weeks postoperative rehabilitation     intervention is more effective than supervised home training, and furthermore to investigate     the cost-effectiveness of the intervention in a societal perspective.      MATERIALS & METHODS The study is performed as a randomized clinical trial. In total 140     patients are included in the study. Inclusion criteria are age above 18 years, patients     diagnosed as having knee arthrosis, patients receiving primary elective TKA, and patients who     are able to and willing transport themselves to the rehabilitation center, which demands     ability to walk 50 meter, and climb 10 stair steps. Exclusion criteria are unicompartmental     or revision arthroplasty, any neurological disease, knee infection, and substantial pain or     functional limitation hindering rehabilitation tested by physiotherapist prior to     rehabilitation start. Primary endpoint is 6 months postoperatively and primary outcome     measure is change in total score by using the knee specific questionnaire Oxford Knee Score.   "
149433|NCT01328080|"     This study is being done to evaluate the effect of targeted UV-B (a component of sunlight) on     the treatment of acne keloidalis nuchae (AKN, or razor bumps on the back of the neck). The     investigators believe targeted UV-B is a safe and effective way to reduce the appearance of     AKN.   "
149360|NCT01329068|"     Carriers of a BRCA mutation have a significantly increased risk to develop breast cancer in     the course of their lives . They face a difficult choice: either a preventive removal of the     breast(s) or an intensive inspection process.      After primary treatment of breast cancer, patients will be followed for 5-10 years to     diagnose recurrence or a new primary tumor in an early stage; to support the patient during     hormonal treatment; to educate the patient about risk factors and healthy life style; and to     provide psychosocial support.      Currently, follow-up of breast cancer patients and surveillance of BRCA mutation carriers is     offered in regular, one-to-one medical visits. Experience shows that in an individual visit     it is often not possible to give all aspects that are important, enough attention. The group     medical consultation (GMC) is a new form of medical visits where the physician or nurse     practitioner performs a series of one-to-one consultations in the presence of 8 to10 other     patients. A social worker accompanies this process. Patients in group consultations may     gather more information because they learn from each other and there is relatively more time     compared to a regular consultation. Research shows that both patients and caregivers are more     satisfied with care after a group consultation compared to individual visits. After a GMC the     participants from the breast cancer GMCs will be provided with a dedicated iPad for 3 months.     Using this iPad, patients can contact the women they have met during the GMC as well as     health care professionals by several communication channels, including virtual group     meetings. This approach provides a unique combination of both social support and professional     education concerning survivorship in an e-health environment.However, it is also known that     group sessions may be counterproductive for some patients, for example because they are     frightened by the stories of others. The goal of this study is to examine whether group     visits (in combination with dedicated iPads) are beneficial to women with a BRCA mutation and     for patients in follow-up after breast cancer.   "
149361|NCT01329055|"     Previous studies of the patients treated in RRI clinics suggest that hemodialysis patients     undergo a certain consistent predictable pattern at the initiation of dialysis and before     death. This pattern can be described as a group of patterns of patients' biological markers     over a few months after starting dialysis and several months prior to death. Additional     patterns can be observed that occur with changes in seasons or time of day. The aim of this     study is to compare these patterns in patients treated in FMC-Asia, FMC-Europe, FMC-South     America, and RRI-US populations. Noting that patterns in patient parameters are similar     across continents, climates, and geographic variations only further accentuates the     importance in the models that can predict patients' survival and provide an opportunity for     timely intervention.   "
149362|NCT01329042|"     Extracorporeal shock wave lithotripsy (ESWL) and Percutaneous nephrolithotomy (PCNL) become     the therapy of choice for renal stone. Although providing good results, stone recurrence is     usually found as the therapies do not change the underlying metabolic abnormality. Among the     metabolic disorders, hypocitraturia is an important risk factor for calcium nephrolithiasis.     This study evaluate the preventive effects of potassium sodium citrate on stone recurrence as     well as stone growth post ESWL or PCNL, in patients with calcium-containing stones.   "
149385|NCT01328730|"     Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating     patients with coronary artery disease (CAD). The efficacy and safety of Cypher SES (Cordis,     MA) has been proved by several randomized clinical trials. Here the investigators design a     prospective, multicenter, randomized clinical study in purpose of identifying the     non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES     (Microport, Shanghai), comparing with Cypher SES.   "
149363|NCT01329029|"     The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets     once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who     are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and     inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of     roflumilast will be obtained. An additional objective is to further characterize the     population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further     characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of     efficacy and relevant safety aspects.      Patients to be included are required to have severe COPD associated with chronic bronchitis     and a history of frequent exacerbations and must be concomitantly treated with a fixed     combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and     placebo) are included.   "
149364|NCT01329016|"     This is a pharmacokinetic and pharmacodynamic study evaluating glyburide, metformin, and     combination treatment for gestational diabetes mellitus.   "
149365|NCT01329003|"     Silicosis is well-known occupational disease caused by free crystalline silica (silicon     dioxide) and is marked by inflammation and pulmonary fibrosis. There are cumulative evidences     that exposure to Caesar stone (quartz surface products that manufactured from up to 93%     quartz, polymer resins and pigments) is particularly dangerous to exposed workers.      Goals: To examine correlation between disease and exposure to Caesar stone and genetic     differences regarding genes involved in oxidative stress to understand Genetic susceptibility   "
149366|NCT01328990|"     The aim of the study is to determine the pharmacokinetic profile of sulfadoxine-pyrimethamine     plus amodiaquine (SP+AQ) when used for seasonal Intermittent Preventive Treatment (IPT) to     prevent malaria in children aged 3 to 59 months in Lamarame, NDoffane District, Senegal.     Several studies have shown that seasonal IPT in children can provide a high degree of     protection against clinical malaria. SP+AQ is the most effective regimen. However little is     known about the pharmacokinetics of amodiaquine and sulfadoxine-pyrimethamine in children.     The purpose of this study is to determine the pharmacokinetics profile of SP+AQ when used for     IPT in Senegalese children. 150 children aged 3 to 59 months will be enrolled in November.     They will receive a therapeutic dose of sulfadoxine-pyrimethamine and amodiaquine, and will     be followed up for 30 days. Four finger prick blood samples will be taken from each child for     PK analysis.   "
149367|NCT01328977|"     This study attempted to identify the best method for educating and engaging academic     physicians in grateful patient philanthropy.   "
149368|NCT01328964|"     The objective of this study is to compare asthma-related exacerbations (emergency department     (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that     received either fluticasone propionate 44 mcg (FP44) or budesonide (BUD) or montelukast     (MON). This retrospective observational cohort analysis utilizes a large managed care     database with linked pharmacy and medical claims. Patients with ≥ 1 pharmacy claim FP44 or     BUD or MON between January 1, 2000 through June 30, 2008 (4-11 years old at time of index)     with ≥ 1 diagnosis for asthma (ICD-9 493.xx) in the pre-index period and continuously     eligible to receive healthcare services for 1-year pre-index and at least 30 days post-index.     Dose of each inhaled corticosteroid was not known in the database. Follow-up was defined for     each patient as the period beginning with the index date and ending with the last date of     continuous claims history, switch to another asthma controller medication, or claim for an     asthma related event (ED/IP visit or OCS use) post-index, whichever occurred first.   "
149369|NCT01328951|"     This double-blind, placebo-controlled study will evaluate the benefit of first-line     maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in     participants with advanced NSCLC who have not progressed following 4 cycles of platinum     based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor     (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150     milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will     receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on     erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will     continue until disease progression, death, or unacceptable toxicity. Participants may also be     entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.   "
149370|NCT01328938|"     This study is adaptive design and it consists of stage I and stage II.      Stage I is multi-center, parallel-group, single-blind, phase II study to determine the     adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will     be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy.      Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the     efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to     Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate     into this phase.   "
149371|NCT01328925|"     The purpose of this study is to determine the effectiveness of nitazoxanide suspension     compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of     age.   "
149372|NCT01328912|"     Remote ischemic preconditioning (RIPC) occurs when a tissue (ex. heart) becomes less     vulnerable to an ischemic insult if a remote tissue (ex. arm) has had previous exposure to a     period of ischemia and reperfusion. A beneficial effect of RIPC has been demonstrated in     several randomized studies in patients undergoing cardiac and vascular surgery, as well as     interventional cardiac procedures such as angioplasty. They have shown improvements in     cardiac, renal, neurologic and respiratory function. Most have focused on surrogate outcomes,     such as biochemical markers of cardiac and renal function in low-risk patients. No trials     have investigated only high-risk patients or been designed to detect clinical outcomes.      This study is a randomized-controlled trial powered to detect clinical events in a high-risk     cohort undergoing cardiovascular surgery. Patients will be randomized to RIPC (exposed to     cycles of inflation of a blood pressure cuff on the upper arm prior to undergoing surgery) or     control (no ischemic stimulus).      The investigators hypothesize this population will demonstrate lower rates of adverse     ischemic events. The investigators also intend to sample biochemical markers to better     elucidate the mechanism of RIPC and generate hypotheses for future studies and interventions.     Post-operatively the investigators will monitor for adverse clinical outcomes including     cardiac, renal, pulmonary and neurologic injury.      RIPC is simple, inexpensive and easily reproducible and there have been no reports of adverse     consequences. Post-operative ischemic events such as stroke, myocardial infarction, cardiac,     renal and respiratory failure affect patient survival and quality of life, and represent a     sizeable financial burden to health care. If beneficial effects of RIPC are demonstrated, it     will be widely applicable to the entire population of cardiac and vascular patients resulting     in a widely-implemented change in practice.   "
149373|NCT01328899|"     This is a multicenter single arm open label study. The primary objective is to evaluate the     safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of     patients with emphysema in multiple centers.   "
149375|NCT01328873|"     Pulmonary infiltrates frequently complicate the care of hematopoietic stem cell transplant     (HSCT) and leukemia patients. Bronchoalveolar lavage (BAL) is frequently used to evaluate new     pulmonary infiltrates in this population, however utility is limited by a historically low     diagnostic yield for infection.      In an effort to improve diagnostic yields, this study will complete a Fiberoptic Bronchoscopy     (FOB) within 8 hours of radiographic documentation of pulmonary infiltrates, prior to     initiating new antibiotic therapy. To further improve detection of microbiological pathogens,     the study will utilize PCR testing with rapid turnaround time to detect atypical pneumonia (M     pneumoniae, C. Pneumonia, Legionella species, and respiratory viruses) and aspergillosis.   "
149376|NCT01328860|"     The purpose of this research study is:        1. To see if Bone Marrow Cell harvest and transplantation are safe in children with Spinal          Cord Injury, and        2. To determine if late functional outcome is improved following Bone Marrow Cell          transplantation in children with Spinal Cord Injury, using pre-transplantation spinal          cord function as the control.   "
149377|NCT01328834|"     This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release     Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).   "
149378|NCT01328821|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     CTP-499 following single dose administration.   "
149379|NCT01328808|"     The purpose of this study is to investigate how acetaminophen (APAP) is released into the     urine and blood; to determine how the blood levels of acetaminophen and its breakdown     products affect the preterm infant's health; to decrease adverse drug reactions; and to     collect data on how the genetic make-up or characteristics affect how APAP is handled within     the preterm infant. By taking several blood and urine samples during the study, we will be     able to check the blood levels (called pharmacokinetics) of APAP in preterm babies.   "
149380|NCT01328795|"     Aims of the study:      Patients in a Chest Pain Unit (CPU) are examined to clarify if the cause of pain is cardiac     or not. To identify patients with ST-elevation and other electrocardiogram (ECG)     modifications a normal 12-lead ECG is used. The diagnosis non-st-elevation myocardial     infarction is determined with the help of the ischemic marker Troponin. However, Troponin     levels are elevated earliest 3 to 4 hours after the ischemic event, so that a negative     Troponin result at the time of hospital admission is insufficient. Thus the guidelines of the     German Society of Cardiology demand a second measurement after 6 to 12 hours. In rare cases     false positive Troponin levels have been reported (e.g. in patients with renal     insufficiency).      The aim of this study is to determine if in the early phase of diagnostic assessment     cardiogoniometry can improve differentiation between patients with cardiac (ischemic)     emergency and patients with non-cardiac (non-ischemic) cause of pain. Furthermore it will be     evaluated if cardiogoniometry is capable to diagnose patients with non-ST-elevation     myocardial infarction (NSTEMI) to the same extent as Troponin. This could avoid time loss     until a possibly necessary catheter intervention (fast track).      To clarify these questions the result of the cardiogoniometry will be compared with the     leading diagnosis of the Chest Pain Unit, the diagnosis at hospital discharge as well as with     the angiographic findings (as a gold standard). Therefore the performance of cardiac     catheterization within 72 hours after start of symptoms is a mandatory inclusion criterion.   "
149381|NCT01328782|"     The goal of this study is to compare different ways of treating pain after surgery. This     research study involves subjects who have a supracondylar elbow fracture and need surgery.     This type of fracture occurs when the humerus (upper arm bone) is broken just above the     elbow. Like any other surgery, you can expect that you will feel pain in the hours or days     after the operation. Currently, despite the common occurrence of this surgery, there is not a     standard way to treat and or prevent any of the pain afterwards.      At this hospital, oral (take by mouth) pain medicine is commonly used to treat pain after     this surgery.      In this study, pain will be treated in one of the following ways:        1. with oral pain medication        2. with oral pain medicine and an intraarticular shot (a shot into the elbow joint) of          bupivacaine (a numbing drug) or        3. with oral pain medicine and an intraarticular shot of ropivacaine (another numbing          drug). The shots will be given during surgery. Your participation will help us find out          which of these three pain control methods works the best.      The correct dosages of all drugs will be safely prescribed by the doctor on an individual     basis and all drugs will be used under the careful watch of your attending physician. All the     drugs used this study are approved by the FDA for use in adults but they are not specifically     approved for use in children. However, nearly 7 out of every 10 drugs approved for adults are     not specifically approved by the FDA for use in children. All drugs used in this study will     be used in a way that is considered to be safe and reasonable by the Children's Hospital.   "
149382|NCT01328769|"     In this study the investigators will recruit hypertensive subjects with higher than average     uric acid levels to test the effect of lowering uric acid with febuxostat on several measures     as listed below. This will be a randomized, double-blind, placebo-controlled, parallel group     study.   "
149383|NCT01328756|"     While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy,     safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and     adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have     been of short duration - up to 8 weeks.      A number of long-term studies have been undertaken (up to 1 year) and these have confirmed     the safety and ongoing efficacy in this patient population.      In order to run a study with investigational medication within Poland the study changed to a     Phase 3 rather than a Phase 4 study in that country. Please note that the study number     remains as SPD489-404.      Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in     children and adolescents over a 2-year treatment period.   "
149384|NCT01328743|"     This is a randomized clinical trial to examine the effects of a brief counseling intervention     for heavy drinking HIV-infected men who have sex with men compared to HIV care as usual. The     study tests the hypothesis that brief counseling will lower drinking in these patients and     that reductions in drinking will be associated with better HIV-related outcomes.   "
149386|NCT01328717|"     Subjects with diabetes and study staff used an investigational blood glucose monitoring     system.   "
153161|NCT01278992|"     The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue when     compared to placebo in nurses involved in shift work.   "
149388|NCT01328691|"     Renal cell carcinoma (RCC) has its propensity to invade the venous system, with extension     into the renal vein and the inferior vena cava (IVC) in 23% and 7%, respectively. Despite     advances in radiation, chemotherapy, and immunotherapy the reference standard for RCC with     tumor thrombus remains surgical resection. However, the 5-year survival rate for patients who     have RCC with venous tumor thrombus treated with radical nephrectomy and tumor thrombectomy     is only 35% - 45%, despite the developments in surgical technique and perioperative care.     Furthermore, even the 5-year survival rate for the patients without the evidence of nodal or     distant metastasis at presentation is just 45% - 65%.      The outcome prediction for RCC remains controversial, and although many parameters have been     tested for prognostic significance, only a few have achieved widespread acceptance in     clinical practice. Currently, pathologic stage (T stage), lymph node status (N stage) and     histologic grade represent the main prognostic variables in the patients with RCC and venous     tumor thrombus. Accordingly, the American Joint Committee on Cancer (AJCC) TNM classification     is regularly revised and, recently, a new 2009 AJCC TNM stage classification system has been     proposed.      RCC is more prevalent in developed countries, such as Europe and North America. It is     relatively less common in Asia; however, the incidence in these regions appears to have risen     over the past decade. Recently, a few series have suggested that racial or ethnic differences     in survival persist after controlling for age and stage in some cancers. In the case of renal     cell carcinoma, it has been demonstrated that the malignancy diagnosed in various ethnic     groups had different clinical characteristics: the presenting symptoms, the course of     disease, and the outcome after standard treatment varied significantly between patients of     Caucasian, Hispanic, African-American, and Asian backgrounds. A recent study has reported     that race as well as established factors has an impact on survival in patients with RCC and     Asian Pacific Islander ethnicity was predictive of improved overall or cancer specific     survival.      Up to date, there was sparse data on surgical outcome and prognostic factors of survival     after radical nephrectomy and thrombectomy in an Asian population with RCC and venous tumor     thrombus, while most studies have been performed in Western countries. The aim of the present     study was to address the surgical outcome after radical nephrectomy with thrombectomy and to     evaluate the prognostic factors influencing on survival in Korean patients with RCC and tumor     thrombus extension into renal vein or IVC, labeled as T3a and T3b-c by the newly revised 2009     AJCC TNM staging system, respectively.   "
149389|NCT01328678|"     The objective of this study is to assess the parathyroid-vitamin D-calcium axis in subjects     with alopecia areata. The hypothesis behind this study is that hypovitaminosis D might     contribute to the pathogenesis of alopecia areata.   "
149390|NCT01328665|"     This project evaluates the effectiveness of an intervention sought to reduce the physical     effects of stress related to those issues that individuals cannot successfully communicate     with anyone about. To do this, the investigators will be implementing a writing intervention     over the course of the 6-week study. The investigators will be asking all participants to     complete questionnaires over the course of the study period. The investigators are also     asking participants to provide a small blood sample (from a fingerstick procedure) at two     times during the study as well as saliva samples during that same time. The primary research     question asks if this intervention procedure is effective. The investigators are evaluating     total cholesterol, high sensitivity c-reactive protein, and cortisol.   "
149391|NCT01328652|"     Main Hypothesis: The investigators hypothesize that measurements of lingual tonsil tissue     (LTT) thickness will decrease following treatment with once daily oral dexlansoprazole 60 mg     in patients diagnosed with laryngopharyngeal reflux (LPR) and lingual tonsil hypertrophy     (LTH) compared to matched controls receiving placebo.      Primary endpoints include:        -  24-hour oropharyngeal pH testing, pre- and post-treatment        -  Mean lingual tonsil tissue (LTT) thickness, pre- and post-treatment, as determined by CT          scan of the base of tongue      Secondary endpoints include:        -  Reflux Finding Score (RFS) on pre- and post-treatment endoscopy of the oropharynx        -  Subjective outcome metrics for assessing LPR-related symptoms and associated quality of          life        -  Calgary Sleep Apnea Quality of Life Index        -  Bed-partner assessment of snoring intensity according to a Visual Analog Scale        -  Epworth Sleepiness Scale (ESS)        -  Reflux Symptom Index (RSI)      Specific Aims: The primary objective of this study is to determine whether treatment of     patients diagnosed with LPR and LTH with 3 months of PPI therapy reduces LTT thickness, as     measured on CT scan of the tongue base.      The secondary objectives of this study are to:        -  Evaluate changes in LPR-related symptoms and quality of life after therapy using the          following subjective outcome metrics:             -  Calgary Sleep Apnea Quality of Life Index             -  Bed-partner assessment of snoring intensity according to a Visual Analog Scale             -  Epworth Sleepiness Scale             -  Reflux symptom index        -  Correlate changes in LTT thickness with the following secondary endpoints:             -  Changes in the above subjective outcome metrics             -  Changes in endoscopic findings of LPR             -  Changes in 24-hour oropharyngeal pH study results   "
149392|NCT01328639|"     Background & Objective: Type 2 diabetes is a complex disease characterized by multiple     comorbidities. Depression is one of the most common comorbidities in individuals with     diabetes with prevalence rates reaching 30%. Depression complicates diabetes treatment,     portends worse outcomes and increases health care costs. One novel approach to managing     diabetes with co-morbid depression is a collaborative primary care model involving a     multidisciplinary health care team guiding patient-centered care. This model has been tested     in the US and showed a significant reduction of depressive symptoms, improved diabetes care     and patient-reported outcomes, and saved money. Our aim is to evaluate the implementation of     this collaborative care model for type 2 diabetes and comorbid depression within the     non-metro Primary Care Network (PCN) setting in Canada.      Intervention: The intervention involves three phases: (1) improving depressive symptoms, (2)     improving blood sugar, blood pressure and cholesterol, and (3) improving lifestyle     behaviours. The intervention is administered by a CM in collaboration with family physicians,     psychiatrists, and internists.      Hypotheses: The TeamCare-PCN intervention will reduce depressive symptoms, achieve targets     for cardio-metabolic measures and improve lifestyle behaviours. Furthermore, the     investigators anticipate this intervention will be acceptable and implemented in a     cost-effective manner in the PCN environment.      Methods: The investigators will employ a mixed-methods approach to our evaluation, using a     controlled on-off trial design. Our primary analysis will be based on a multivariable     scaled marginal model for the combined outcome of depressive symptoms and medical care.     Secondary analyses will assess changes in lifestyle behaviours and patient-reported outcomes.      Significance: Our work will serve as a platform upon which an emerging model of primary care     can incorporate an effective and cost-effective depression intervention into the management     of individuals with type 2 diabetes, and as a framework for implementing and evaluating     similar interventions in individuals with other chronic conditions.   "
149393|NCT01328626|"     This is a Phase 1, open-label, multicenter study evaluating the safety and PK profile of     ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose escalation:     Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll approximately     116 subjects with relapsed or refractory CLL or SLL and Arm B is designed to enroll     approximately 95 subjects with relapsed or refractory NHL. Fifty-six subjects were enrolled     in Arm A and approximately 55 subjects will be enrolled in Arm B during the dose escalation     portion of the study, with the objective of defining dose limiting toxicities (DLTs) and the     MTD. Once the MTD is declared for the arm, approximately 60 additional CLL/SLL subjects in     Arm A and approximately 20 additional DLBCL subjects and 20 additional follicular lymphoma     subjects in Arm B will be enrolled in an expanded safety portion of the study at the     recommended phase 2 dose (RPTD) and schedule.   "
149399|NCT01328548|"     This study is being done to evaluate the zoster vaccine response in the nursing home elderly     (80 years or older). As the immune system ages, the response to vaccines is not always as     strong as in younger people. Previous zoster vaccine studies have excluded nursing home     residents so the vaccine effect in this population is not known. Furthermore, the immune and     genetic reasons as to why the vaccine works well in some people but not in others are also     unknown. The goal of this study is to evaluate why some immune systems respond well to the     vaccine and why others do not.   "
149400|NCT01328535|"     This clinical trial studies individualized temozolomide (TMZ) in treating patients with stage     IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as TMZ, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving TMZ at different times, which are determined individually     for each patient based on the phase (biorhythm) of the immune system response against the     tumor may allow for a better drug response and may kill more tumor cells   "
149394|NCT01328613|"     Background:      - Postpartum depression (PPD) is a serious syndrome that resembles a major depressive episode     and occurs in 10% to 20% of all mothers in the year following delivery. Women with histories     of major depressive disorder (MDD) are at an increased risk for PPD and recurrent PPD with     subsequent pregnancies. One possible genetic vulnerability to depression and PPD in     particular is the BDNF gene. BDNF is a protein that affects the growth and development of     brain cells, including those that help to regulate mood. BDNF levels have been shown to be     significantly lower in individuals with depression, including women. Researchers are     interested in studying BDNF levels and hormones such as estrogen in pregnant women who have     MDD and are at risk for developing PPD.      Objectives:      - To study connections between the BDNF protein and hormonal levels in pregnant women who are     at risk for developing postpartum depression.      Eligibility:      - Women who are currently pregnant and have a history of major depressive disorder, and     either are taking a selective serotonin reuptake inhibitor (SSRI) or are not taking an     antidepressant.      Design:        -  This study involves six visits over the course of 12 months, during the first, second,          and third trimesters (if possible) as well as 1 week, 1 month, and 3 months postpartum.          Women will be allowed to participate at any point during pregnancy, but researchers are          most interested in recruiting women who are in the first trimester.        -  Participants will be screened with a physical examination and medical history, blood          samples, and questionnaires about their history of depressive episodes.        -  At each visit, participants will complete a number of questionnaires on depression          symptoms, such as sleep disturbance and stress levels. Participants will also provide          blood samples for hormone and other testing.        -  Participants who become depressed during the study will be referred to a treating          psychiatrist or other professional for appropriate care and treatment.   "
149395|NCT01328600|"     Background:        -  Preeclampsia is a combination of high blood pressure and other potentially          life-threatening symptoms. Preeclampsia occurs in up to 10% of pregnancies and is a main          cause of maternal and fetal death worldwide. Treatment is often difficult, and so far          there is no specific and effective therapy. Researchers have been studying the body          systems that regulate blood pressure. They have also studied drugs that can control          certain blood chemicals that constrict blood vessels and increase blood pressure.        -  DIGIBIND, a drug that lowers blood pressure, has been used to treat pre-eclampsia.          Marinobufagenin (MBG), a chemical in the blood that constricts blood vessels, has been          shown to be involved in pre-eclampsia. But researchers are still not certain whether          DIGIBIND can be used to specifically target MBG. Researchers want to find out whether          DIGIBIND acts against MBG specifically. This information may help them to develop better          drugs to block MBG and lower blood pressure in women with preeclampsia.      Objectives:      - To study whether the blood pressure treatment drug DIGIBIND specifically acts on     marinobufagenin levels in the blood of pregnant women.      Eligibility:      - Women between 18 and 50 years of age who are 34 to 39 weeks pregnant and have preeclampsia.      Design:        -  Participants will be screened with a physical examination, medical history, and blood          and urine tests.        -  Before delivery, participants will provide blood samples for testing and evaluation.        -  Following delivery, participants will provide additional blood samples and samples of          the placenta for testing and evaluation.        -  No additional treatment, apart from the standard of care, will be provided as part of          this protocol.   "
149416|NCT01328301|"     This study aimed to explore whether speed-dependent treadmill training is more effective at     improving walking and balance performance than speed-stable treadmill training in patients     with subacute stroke. Twenty-six patients with stroke completed 2 weeks of treadmill     training. Results showed that speed-dependent treadmill training is more effective at     improving walking speed and step length than speed-stable treadmill training in patients with     subacute stroke.   "
149417|NCT01328288|"     The purpose of this study is to study the HIV disease progression in HIV-infected Thai     children.   "
149418|NCT01328275|"     The purpose of this study is to study the HIV disease progression in HIV-infected Thai Adult.   "
149396|NCT01328587|"     Background:        -  Moderate aplastic anemia is a blood disease which may require frequent blood and          platelet transfusions. Sometimes patients with this disease can be treated with          immunosuppressive drugs. Not all patients respond and not all patients are suitable for          this treatment.        -  Thrombopoietin (TPO) is a protein made by the body. The bone marrow needs TPO to produce          platelets. TPO may also be able to stimulate bone marrow stem cells to produce red cells          and white cells. However, TPO cannot be given by mouth. This has led researchers to          develop the drug eltrombopag, which acts in the same way and can be given by mouth.          Eltrombopag has been shown to safely increase platelet numbers in healthy volunteers and          in patients with other chronic blood diseases, including severe aplastic anemia.          Researchers are interested in looking at whether eltrombopag can be given to people with          moderate aplastic anemia and significantly low blood cell counts.      Objectives:      - To evaluate the safety and effectiveness of eltrombopag in people with moderate aplastic     anemia or patients with bone marrow failure and unilineage cytopeniawho need treatment for     significantly low blood cell counts.      Eligibility:      - People at least 2 years of age who have moderate aplastic anemia or bone marrow failure and     unilineage cytopenia,and significantly low blood cell counts.      Design:        -  Patients will be screened with a physical examination, medical history, blood tests, a          bone marrow biopsy, and an eye exam.        -  Patients will receive eltrombopag by mouth once a day.        -  Patients will have weekly blood tests to monitor the effectiveness of the treatment and          adjust the dose in response to possible side effects.        -  Patients may continue to take eltrombopag if their platelet count or hemoglobin          increases, their requirement for platelet or blood transfusion decreases after 16 to 20          weeks of treatment, and there have been no serious side effects. Access to the drug will          continue until the study is closed. Patients will be asked to return for a follow-up          visit 6 months after the last dose of medication.   "
149397|NCT01328574|"     Background:      - Urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis) often responds     initially to standard chemotherapy treatments, but frequently recurs and can often spread to     other parts of the body. TRC105, an experimental drug that blocks the development of the new     blood vessels needed for tumor growth, may be able to shrink or stabilize urothelial cancer     tumors. TRC105 has been given previously to individuals with other types of cancer, and     researchers are interested in determining its safety and effectiveness in treating urothelial     cancer.      Objectives:      - To determine the safety and effectiveness of TRC105 as a treatment for metastatic     urothelial cancer that has not responded to standard treatments.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with urothelial cancer that     has spread to other parts of the body and has not responded to standard chemotherapy.      Design:        -  Participants will be screened with a physical examination, medical history, blood tests,          and tumor imaging studies.        -  Participants will receive TRC105 intravenously once every 2 weeks on days 1 and 15 of a          28-day treatment cycle. The first dose of TRC105 will be given over a 4-hour period;          participants who do not have side effects may receive the next dose over 2 hours. If the          second dose is tolerated, subsequent doses can be given over at least 1 hour.        -  To help prevent known side effects of TRC105, participants will take two doses (one in          the morning and one in the evening) of the steroid dexamethasone on the day before each          infusion is scheduled. Participants may have additional dexamethasone 30 minutes before          infusion, and may have the infusion slowed or stopped to adjust for side effects.        -  Participants will be monitored with blood samples, physical examinations, and tumor          imaging studies through the cycles of treatment.        -  Participants will continue to take TRC105 for as long as the treatment is effective          against the cancer and as long as the side effects are not severe enough to stop          treatment.   "
149398|NCT01328561|"     Background:      - Oxytocin, a substance produced mostly in the brain, plays a role in influencing social     interactions and reactions to stress, and may be related to pain. Arginine vasopressin, a     hormone that regulates water, sugar, and salt in the blood, influences hostile behaviors and     reactions to stress, and may also be related to pain. Researchers are interested in     investigating both substances and their relationship to pain in healthy volunteers.      Objectives:      - To evaluate the effects of oxytocin and arginine vasopressin on pain in healthy volunteers.      Eligibility:      - Healthy volunteers between 18 and 55 years of age.      Design:        -  This study involves two 2-hour testing sessions held 1 day apart. Each session includes          the administration of oxytocin, arginine vasopressin, or placebo (a nonactive          substance), or no drug. The drugs and the placebo will be given by a nasal spray.        -  At the first visit, participants will provide blood and saliva samples to measure          hormone levels, and will be asked to fill out questionnaires about some psychological          factors such as anxiety and empathy. Participants will then have an assessment of their          sensitivity to pain, consisting of a brief electrical stimulation that lasts less than 1          second. After the pain assessment, participants will receive oxytocin, arginine          vasopressin, placebo, or no drug at all, and will be monitored to provide baseline          information. Participants will then have another pain sensitivity test and will complete          the questionnaires again, and provide another saliva sample.        -  At the second visit, participants will provide another saliva sample; receive oxytocin,          arginine vasopressin, placebo, or no drug at all; and have tests of pain sensitivity and          a pain-relieving procedure. During the pain-relieving procedure, participants will          receive brief, moderately painful electrical shocks on the back of the nondominant hand          and a low-level electrical stimulation on the middle finger that counteracts or reduces          the pain from the shocks. Participants will rate their pain perception at the end of          each stimulation by using a visual scale ranging from 0 (no pain) to 10 (maximum          imaginable pain). The experiment ends with a final saliva collection and completion of          the psychological questionnaires....   "
149401|NCT01328522|"     Primary Objective:      Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after     a single dose administration in rheumatoid arthritis patients.      Secondary Objective:      Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products     after a single dose administration in rheumatoid arthritis patients.   "
149402|NCT01328509|"     The purpose of the proposed project is to investigate measures of zinc status in relation to     oxidative stress and inflammation in patients with sepsis. We hypothesise that zinc depletion     can modulate inflammatory responses, leading to increased oxidative stress and mitochondrial     dysfunction.      Sepsis is a severe infection is the leading cause of death in critically ill patients [1].     Zinc deficiency impairs overall immune function and resistance to infection [2]. In vitro     exposure of monocytes to lipopolysaccharide (LPS) leads to decreased cellular zinc content     [3] and zinc redistribution has been shown in human volunteers in response to LPS [4]. Zinc     depletion occurs in hospitalized patients including those with infections, the elderly,     alcoholics, trauma or burns [5-8], conditions which are common among critically ill patients     with sepsis. In a mouse model of sepsis, zinc depletion prior to sepsis resulted in more     inflammation and more severe organ injury and increased mortality [9]. In patients with     sepsis, early feeding with zinc resulted in faster recovery of organ function compared with     control [10]. Zinc status is likely to be compromised in the critically ill and that zinc     depletion may affect inflammatory responses and recovery.      Although zinc is not an antioxidant itself, it binds to metallothionein [11] and zinc     supplementation decreases oxidative stress [12]. Oxidative stress has been consistently     reported in patients with sepsis [13-15]. We have recently shown that protection of     mitochondrial function with antioxidants can reduce organ damage in rats [16]. Pentraxin-3 is     an inflammatory marker which is regulated in part by antioxidants and plays a key role in     innate immunity [17].      The consequences of zinc deficiency may relate, in part, to its effects on nuclear factor     NFκB, a transcription factor crucial to the signalling networks involved in sepsis [18].     Higher NFκB activity is associated with increased mortality in patients with sepsis [19,20].     It is likely that compromised antioxidant defences and inflammation occurs as a consequence     of zinc deficiency.      We propose to measure plasma zinc and metallothionein mRNA status in relation to inflammatory     markers including key cytokines, pentraxin-3, markers of oxidative stress and antioxidant     status in patients with sepsis.   "
149403|NCT01328496|"     In this study, participants with high-risk hematologic malignancies undergoing hematopoietic     cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA)-matched     related/sibling donor (MSD), matched unrelated donor (MURD) or killer-immunoglobulin     receptors (KIR) ligand mismatched haploidentical donor identified, will receive an umbilical     cord blood transplantation (UCBT) using a myeloablative preparative regimen.      The preparative regimen includes fludarabine (75 mg/m2), fractionated total body irradiation     (TBI) (10.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a     day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy     for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at     60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with     cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF     will start on day +1.   "
149419|NCT01328262|"     The aim of this study is to evaluate whether the targeted hemoglobin increment (2 grams per     decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag     transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the     control group, the prescribed number of red cell units will be transfused.      Hypothesis: By matching the hemoglobin dose to the individual needs of the patient the     investigators will reduce the total usage of red cell concentrates.   "
149404|NCT01328483|"     The purpose of the study is to evaluate the role of routine suctioning of the oropharynx     before the delivery of shoulders in preventing breathing difficulty and subsequent lung     disease in babies born through meconium stained amniotic fluid. Normally babies do not pass     meconium while in utero. In response to hypoxic stress babies may pass meconium before birth     and are likely to be candidates for problems related to meconium passage and its inhalation     leading to meconium aspiration syndrome(MAS). It is believed that clearing the airways of     meconium at the time of birth can decrease the risk of MAS. It had been a routine practice to     suction the mouth, pharynx and nose of the baby as soon as the head of the infant is     delivered prior to delivery of the shoulders followed by tracheal intubation and suction in     babies with poor breathing efforts to clear the airways of the meconium. however recent     studies have shown the futility of this procedure in preventing MAS along with an increased     risk of complications to baby due to suctioning. In view of the uncertainty regarding the     effectiveness of this procedure in a resource poor country, the investigators decided to     evaluate the effect of intrapartum-oropharyngeal suction in preventing or decreasing the     incidence of MAS in such babies.   "
149405|NCT01328470|"     Impaired renal function is associated with reduced responsiveness to clopidogrel. There are     no studies which have shown a means by which to overcome platelet hyporesponsiveness in     patients with chronic kidney disease (CKD). The purpose of this study was to determine the     functional impact of cilostazol in patients with CKD undergoing hemodialysis.   "
149406|NCT01328457|"     The purpose of this study is to evaluate the effectiveness of treatment with PMIM in patients     with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT (21/22 days     after treatment begins), and at 6 months after end of treatment (Day 202/203, -15 to +30     days).   "
149407|NCT01328444|"     This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination     and component, two-period, incomplete block design cross-over study using GSK573719/GW642444.     The primary objective is to evaluate lung function and exercise endurance time after 12 weeks     of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and     62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25     mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI)   "
149408|NCT01328431|"     This study will test the effectiveness of an Emergency Department (ED) initiated tobacco     intervention which includes counseling and medication. Our proposed intervention combines a     Brief Negotiated Interview (BNI) with initiation of nicotine patch and gum in the ED, as well     as a faxed referral to the state's Smokers' Quitline. A 6 week supply of nicotine patches and     nicotine gum are provided to subjects in the intervention arm. Subjects randomized to the     control arm will receive a brochure from the state's Smokers' Quitline only.      The primary hypothesis is that the intervention will be superior to the control condition in     reducing self-reported and biochemically verified 7-day tobacco abstinence at 3 months.   "
149409|NCT01328418|"     The purpose of this study is to determine whether lengthening of both the tibiae and femora     in achondroplastic patients is safe and provides reproducible outcome.   "
149410|NCT01328405|"     Introduction:      The air-QⓇ Intubating Laryngeal Airway (ILA) is a newer supraglottic airway. It is approved     for use as a primary airway and as an aid for intubation in situations of anticipated or     unanticipated difficult airways. A unique feature of this device as compared to other airways     on the market is the size of the inner diameter (ID) and length of its airway tube. Direct     placement of tracheal tubes > 7.5 mm ID through the airway tube is possible.      The ProSealTM LMA is considered the gold standard for supraglottic devices with respect to     airway seal pressure. On average, it is reported to be approximately 28 cmH2O. This is     significantly higher than that of the first generation LMA, the LMA-ClassicTM, which has a     maximum seal pressure of 20 cmH2O, but averages 16-18 cmH2O in actual practice.      In this study the investigators aim to test whether the air-QⓇ creates an airway seal     pressure that is similar to the LMA-ProSealTM, whether the position of the air-QⓇ in relation     to the vocal cords, as assessed by fiberoptic endoscopy, is similar to that of the     LMA-ProSealTM and whether airway morbidity is similar between the air-QⓇ and the     LMA-ProSealTM.   "
149437|NCT01328028|"     The aim of this study is to assess the distribution of the most frequent types of human     papillomavirus in women diagnosed with invasive cervical cancer in New Zealand.   "
149411|NCT01328392|"     Although laryno-pharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD) differ in     symptoms and treatment, they are diagnosed by the same standard 24-hour pH monitoring system     which measures liquid reflux in the esophagus. The investigators are evaluating a new 24-hour     pharyngeal pH monitoring system by Restech which can measure acid exposure in the airway and     can be used specifically for LPR diagnosis. The purpose of this study is to determine whether     the Restech device is more effective than standard pH monitoring in predicting the response     to proton pump inhibitor (PPI) acid suppression therapy using Dexlansoprazole in patients     with symptoms and/or manifestations of LPR.   "
149412|NCT01328379|"     The purpose of this study is to investigate the safety and efficacy of a lower dose of     dalfampridine extended release tablets compared to the currently approved dose in improving     walking in Multiple Sclerosis (MS) patients.   "
149413|NCT01328366|"     The impact of psoriasis on an individual's emotional and social well-being goes beyond skin     symptoms of the disease. Data suggests patients with severe psoriasis experience a greater     prevalence of depressive symptoms, mood disturbances, anxiety and even suicidal ideation.     Given the nature of the disease and the treatment failures which are required before a     patient commences a biologic therapy such as adalimumab, the patient's mental health at     initiation of biologics is an important consideration for clinicians. This study seeks to     explore if adalimumab treatment of psoriasis leads to a positive impact on psychosocial     factors and disease-related quality of life.   "
149414|NCT01328353|"     The overall objective of this study is to evaluate the effectiveness of a telehealth care     coordination and case management nursing intervention for children with complex special     health care needs.   "
149420|NCT01328249|"     The purpose of this study is to assess the feasibility of dose-dense doxorubicin and     cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast     cancer.   "
149421|NCT01328236|"     Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage     therapy for Multiple Myeloma (MM).      The present study is designed to assessment the efficacy and safety study of Bortezomib in     combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia     (PCL).      Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is     the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of     response (DOR), overall survival (OS).   "
149422|NCT01328223|"     Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients     present with intermediate or advanced disease. Percutaneous ethanol injection, radiofrequency     ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a     curative treatment and have achieved very limited success in eradicating large HCC. With the     development of new radiotherapy (RT) technique, RT can be more safely given to patients with     larger tumor burden. Thus, TACE combined with RT has been suggested for treating large HCC.     Based on the results of these studies, RT could achieve a tumor response rate of 50 % to 70     %. However, it has not been definitively shown to prolong the overall or disease-free     survival due to lack of a phase III clinical trial. In contrast, a retrospective clinical     investigation with molecular study suggests that sublethal dose of RT promoted HCC growth     outside RT field.      Two phase III trials were shown to be efficacious and well-tolerated in patients with     advanced HCC. Median overall survival was significantly 2 to 3 months longer in the sorafenib     group than that in the placebo. It is interesting to recognize the combined therapeutic     effect of RT with sorafenib. Based on several preclinical experiments, tumor angiogenesis     inhibitors seem to be synergistic with irradiation when using before RT, concurrently with     RT, or after RT. Thus, the investigators design a single-arm phase II clinical trial to     investigate the efficacy of combined RT with sorafenib.      The eligibility criteria are patients with unresectable HCC; good performance status; no     prior radiotherapy for the liver; clinical measurable tumor; good liver function and good     compliance. After entering this study, the testee will receive RT to hepatic tumor with     concurrently sorafenib with a dose of 400 mg twice daily. Hepatic RT will be performed with a     daily fraction size of 2.0 to 2.5 Gy to a total dose of 46 Gy to 60 Gy. After RT, maintenance     sorafenib with a dose of 400 mg twice daily will be ongoing. Sorafenib will be continued     until the occurrence of clinical or radiologic progression, or the occurrence of either     unacceptable adverse events or death. Minimum maintenance duration of 6 months is     recommended, but not mandatory.   "
149423|NCT01328210|"     Metabolic syndrome (MS) has an increasing prevalence worldwide and there is an urgent need     for improvement of medical treatment. In traditional medicine phlebotomy (blood letting) is a     recommended treatment for subjects with obesity and vascular disease. Recent studies showed     that blood letting with iron depletion may improve insulin sensitivity in patients with     diabetes mellitus. The investigators aimed to test if traditional blood letting has     beneficial effects in patients with MS. A randomized trial with a sample size of 64     self-referred MS patients was conducted. Patients in the blood letting group were allocated     to blood letting intervention and the control group was offered a later treatment (waiting     list). In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after     4 weeks. Primary outcomes were the change of systolic blood pressure and of insulin     sensitivity as measured by HOMA-Index.   "
149424|NCT01328197|"     The primary goal of the study is to assess the safety and performance of the Treovance device     in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased     pathology can be treated with an acceptable adverse event rate and that the device performs     as expected. The results of this study will permit the establishment of endpoints and     clinical design for a subsequent U.S. trial.   "
149425|NCT01328184|"     The objective of this study is to investigate the possible effect of multiple oral doses of     25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and     levonogestrel (LNG) (Microgynon®).   "
149426|NCT01328171|"     The aim of the trial is to optimize response rates and rates of secondary resections of     metastases in patients with initially non-resectable metastatic colorectal cancer of RAS     wildtype. The patients will be treated in two therapy groups:      Experimental arm A: Chemotherapy with FOLFOXIRI + panitumumab Standard arm B: Chemotherapy     with FOLFOXIRI   "
149427|NCT01328158|"     This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify     the following with regard to treatment with this drug:        1. Incidence and conditions of occurrence of adverse reactions in the clinical setting        2. Factors that may affect the safety and effectiveness of Kaletra (QD)   "
149428|NCT01328145|"     The pathomechanisms of COPD are still not fully understood, and up to now there is no     satisfying causal treatment inhibiting the progress of the disease. Available therapy is in     most cases symptomatic. Experimental and clinical observations suggest that treatment with     ASA might be beneficial in the treatment of COPD in terms of respiratory and lung-functional     improvement.      To evaluate the efficacy of ASA as add-on therapy in COPD in comparison to placebo a     prospective, randomized, double-blind, placebo controlled study will be conducted. Adult male     and female patients (n=74) with proven COPD GOLD grade II-III will be randomized to 2 groups     (i.e. 37 patients per group, stratification according to smoking status and gender). They     will receive either 500 mg ASA per day or matching placebo over 12 weeks. Primary efficacy     endpoints are changes in the lung-functional parameter FEV1 (forced expiratory 1-second     volume) after 12 weeks of treatment. Secondary endpoints are the health score of the St.     Georges respiratory questionnaire (SGRQ) and Peak-flow (PEF).   "
149429|NCT01328132|"     The primary aim of this study is to assess the effect of hyperoncotic albumin on vascular     hemodynamics and oxygen delivery after orthotopic liver transplant. The secondary aim is to     try to identify the dominant physiological mechanism so that we will be able to better     identify patients that may benefit from the use of albumin (25%) boluses in addition to     standard care in patients following liver transplantation.   "
149430|NCT01328119|"     Rationale: The mortality of end-stage renal disease (ESRD) patients on dialysis remains high.     This may at least be partly due to the insufficient removal of (especially protein-bound)     uremic toxins which have been associated with cardiovascular morbidity and mortality. It is     unknown whether the combination of long-hour haemodialysis (HD) with convection increases the     removal of these toxins. Long-hour HD and long-hour haemodiafiltration (HDF) may also improve     haemodynamic stability which is an important factor in treatment quality. The investigators     aim to study the removal of uremic toxins in long-hour HD and HDF and to compare the     haemodynamics between 4-hour and 8-hour HD and HDF.      Objectives: The primary aim is to study the removal of (especially protein-bound) uremic     toxins in 4-hour and 8-hour HD and HDF. A secondary aim is to compare the haemodynamic     response between 4-hour and 8-hour HD and HDF.   "
149431|NCT01328106|"     The purpose of this study is to determine whether GSK1120212, a MEK inhibitor, is an     effective and safe treatment for cancer subjects with metastatic uveal melanoma and     mutation-positive GNAQ or GNA11 metastatic melanoma.   "
149434|NCT01328067|"     The objective of this trial is to evaluate the safety and efficacy of ExAblate for the     treatment of uterine fibroids.      Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the     study.Women who agree to participate will sign an informed consent and will be randomized to     ExAblate treatment or myomectomy.      All patients will be followed through the 36 month visit. Follow-up visits/telephone calls     will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post     treatment.      Patients will be evaluated by assessing their overall physical and mental health as well as     for device/procedure related adverse events.   "
149435|NCT01328054|"     This study will estimate the effect of lapatinib on cardiac repolarization (QTc interval     duration) in subjects with advanced solid tumors. The study treatment period will occur over     five days and an End of Study visit will be conducted on Day 8 (or no later than 3 days     beyond Day 8). Subjects will receive placebo that mimics lapatinib for 2 days as three     separate doses given 12 hours apart (8 tablets/dose) and lapatinib (2000mg) for 2 days as     three separate doses given 12 hours apart (8 tablets/dose). Subjects will not know when they     are receiving placebo vs. lapatinib. Digital 12-lead ECG recordings will be extracted from     continuous ECG recordings obtained via a Holter monitor to measure QTc interval duration.     Triplicate ECG measurements of QTc interval will be taken at pre-specified times at Day 1     (Baseline) and pre-dose and up to 24 hours after the third dose of placebo or lapatinib on     Study Days 2 and 4. Pharmacokinetic sampling will occur immediately following each     pre-specified QTc measurement in subjects dosed with placebo or lapatinib. Subjects who     complete participation in this study, if they are eligible, will be offered the option to     continue treatment with lapatinib, either alone or in combination with other oncology drugs     in pre-selected anticancer regimens, in a continuation protocol, EGF111767.   "
149436|NCT01328041|"     The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir     (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults     with current or historical failure on an integrase inhibitor (INI) containing regimen. The     study will assess DTG 50mg twice daily administered initially with the current failing ART     regimen but then with an optimised background ART regimen (OBR) after Day 7. The first     analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects     may remain on study after Week 24.   "
149438|NCT01328015|"     A study in which the experimental treatment procedure is compared to a standard (control)     treatment, The use of oxybutynin in the late postoperative thoracic sympathectomy for women:        1. To Evaluate the effect of oxybutynin on plantar hyperhidrosis.        2. To evaluate the effect of oxybutynin in compensatory hyperhidrosis.        3. To compare the results of questionnaires on quality of life and specific for          hyperhidrosis to the results of TEWL.   "
149439|NCT01328002|"     The purpose of this study is to evaluate the safety, tolerability, efficacy, and     pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary     fibromyalgia.   "
149440|NCT01327989|"     The objective of this study was to obtain prospective clinical data on the safety and     efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke.   "
149441|NCT01327976|"     The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro     Rechargeable System compared to a sham control for the treatment obesity. The Maestro     Rechargeable System delivers intermittent, electrical blocking signals to the anterior and     posterior trunks of the intra-abdominal vagus nerve (termed vBloc Therapy) and is designed to     reduce sensations of hunger and produce satiety leading to weight loss. After approval from     the institutional review board, subjects provided written consent and were randomized in a 2     to 1 allocation to vBloc group (with laparoscopic placement of the leads and neuroregulator)     or the sham group (placement of a custom sham neuroregulator only) on double-blinded basis.     Both groups received similar diet and exercise counseling. Weight, adverse events, clinical     laboratories, ECGs, eating questionnaires and quality of life data were evaluated throughout     the 12 month study duration.   "
149442|NCT01327963|"     The purpose of this open-label, postmarket study is to evaluate the safety and efficacy of     transoral incisionless fundoplication (TIF) performed with EsophyX in a broad range of     gastroesophageal reflux disease (GERD) patients treated at high volume centers across the     United States.   "
149443|NCT01327950|"     This is a national, prospective, multi-center, non-randomized study to evaluate the long-term     efficacy and integrity of the EPICTM Nitinol Vascular Stent System in Superficial Femoral     Artery (SFA) lesions. A total of 100 patients will be included in approximately 10 sites. The     study is designed to demonstrate the EPIC Nitinol Vascular Stent System is non- inferior to     the published patency rates found in the literature. This non-inferiority will be established     by proving that the true rate for the EPICTM Nitinol Vascular Stent System is higher than 82%     minus a 10% delta.   "
149444|NCT01327937|"     The overall study objective is to use microarray technology to identify and characterize the     gene expression of multiple relevant genes in biopsies of non-healing venous ulcers.   "
149445|NCT01327924|"     This study is conducted in Europe. The purpose of this study is to assess the impact on daily     life for children new to using a growth hormone injection device.   "
149446|NCT01327911|"     This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate     the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.   "
149447|NCT01327898|"     The specific aims of the 5-year study are to: 1) describe the nature and extent of substance     use and sexual risk behaviors in a sample of 500 sexually active, substance using,     not-in-treatment men who have sex with men (MSM) in urban South Florida (Miami/Ft.     Lauderdale); 2) identify the independent covariates of baseline substance abuse and sexual     risks; 3) evaluate, through random assignment of participants, the relative effectiveness of     two intervention conditions in reducing sexual risks and substance use, as measured at 3-,     6-, and 12-month follow-up assessments: a) an innovative five-session risk reduction     intervention derived from psychological empowerment theory titled Project GOAL; and, b) an     enhanced community standard-of-care HIV counseling Comparison Condition.   "
149491|NCT01327313|"     The primary objectives are to assess the safety and tolerability of single and repeated doses     of EMD525797, and characterize Pharmacokinetics (PK). The secondary objectives are to     investigate the immunogenicity and Progressive disease (PD), and to assess the anti-tumor     activity of EMD525797.   "
149448|NCT01327885|"     This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and     safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have     disease progression within 6 months prior to study enrolment following standard therapies     which must have included an anthracycline, unless contraindicated and then at least one     additional regimen after failure of the anthracycline.   "
149449|NCT01327872|"     This will be a randomized, open-label, four-group, two-period, replicate design study to     evaluate the effect of food on within and between subject variability in second generation     formulation 20-mg tablet strengths, Lots P01008ZZA and P01009ZZA, administered as single     doses of 40mg to 84 healthy male and female subjects. The study is powered to detect both a     reduction in either the within or between subject variability (coefficient of variation     [CV]%) of approximately 35%.   "
149450|NCT01327859|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of donepezil     (Aricept) in Parkinson's Disease (PD) patients with dementia.   "
149451|NCT01327846|"     Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial is to test the     hypothesis that canakinumab treatment of patients with MI at least one month prior to study     entry and elevated hsCRP will prevent recurrent cardiovascular events.      The purpose of the extension phase of the main study is to collect additional long-term     safety data on continued exposure to canakinumab in patients who participated in the pivotal     phase.      Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study is to evaluate the effect of     quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the     carotid plaque burden measured by integrated vascular MRI in patients enrolled in the     CACZ885M2301 study (CANTOS).      Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study is to determine whether,     in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared     to placebo, on top of standard of care increases insulin secretion and insulin sensitivity.   "
149452|NCT01327833|"     The purpose of this study is based on method Utstein, registering all recommended items of     that model, in addition to adding more information, characterizing this way using a template     Utstein modified for the epidemiology of PCR-hospital in Brazil.      Objectives: establish a registry of patients suffering from respiratory (PCR)-hospital to     assess demographic and clinical variables such as morbidity, mortality and standard practice     in cardiopulmonary resuscitation (CPR). In addition, assess independent predictors associated     with survival in several times and survival curves.   "
151036|NCT01306864|"     The objective of this study is to show that Hemospray is effective in achieving initial     hemostasis and documenting rate of further bleed when compared to standard of care.   "
149454|NCT01327807|"     Cure Cystinosis International Registry (CCIR) is an online, patient self-identifying registry     developed by medical and scientific experts specifically for the cystinosis community.      CCIR's sole purpose is to identify people with cystinosis worldwide in an effort to     accelerate novel treatments and a cure for cystinosis.      CCIR provides a safe and secure platform for:        -  sharing anonymous medical information about cystinosis with researchers, clinicians and          patients        -  disseminating information about research opportunities        -  connecting researchers/investigators and prospective participants *      Interested cystinosis patients may register themselves with CCIR online at     http://www.cystinosisregistry.org.      * No personal information is shared outside of CCIR. Individual identities are known only to     appropriate CCIR staff. If a participant is matched to a clinical trial, the participant     receives a notice from CCIR, after which they can decide whether they wish to contact the     study sponsor.   "
149455|NCT01327794|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer. It may also help doctors     predict how well patients will respond to treatment.      PURPOSE: This research trial is studying the relationship between vitamin D biomarkers and     survival in blood samples from patients with advanced pancreatic cancer.   "
149456|NCT01327781|"     This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in     treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to     other places in the body (metastatic) or has come back at or near the same place as the     original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells.     Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use     of estrogen by tumor cells.   "
149457|NCT01327768|"     Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1     to 2 months before transplantation. The Olfactory Ensheathing Cells (OECs) will be cultured     and expanded under the rule of GTP. Then, quality control of OECs should be done by     immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators     will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area     of the brain.   "
149458|NCT01327755|"     Study Hypothesis: The addition of selenium supplementation to cotrimoxazole will improve CD4     counts, decrease opportunistic infections, decrease viral loads and delay the need for     initiating antiretroviral therapy(ART) in Rwandan adult patients infected with HIV/ AIDS.   "
149459|NCT01327742|"     This study is a continuation of the pivotal trial studying the safety and efficacy of the     Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being     evaluated by the device-related adverse event rate of endovascular repair (via the Relay     thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse     events through 1 year in subjects treated with the Relay thoracic stent-graft to those who     underwent surgical repair.   "
149460|NCT01327729|"     The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated     interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and     with no prior treatment for hepatitis C virus (HCV).      Methods: Randomized, Open-label trial, in 3 parallel groups (each of 100 patients)   "
149461|NCT01327703|"     This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000     compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis     (CF) and exocrine pancreatic insufficiency (EPI).   "
149462|NCT01327690|"     PTSD (posttraumatic stress disorder) and associated mental health conditions affect both     veterans and their family members. This study investigates whether group therapy using EFT     (Emotional Freedom Techniques) and CBT (Cognitive Behavior Therapy) produce reductions in     PTSD and comorbid symptoms.   "
149463|NCT01327677|"     This research is being done to compare two methods of giving fentanyl, a narcotic often given     to patients following brain surgery and determine if one method has more side effects than     the other. Both of these methods are available in the postoperative treatment of pain. This     research also is being done to determine if patients receiving narcotic pain medicine will     benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines     can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide     levels will help identify a slower breathing rate and improve safety.   "
149464|NCT01327664|"     This study will provide patients who have completed the AIN457 Phase II and Phase III     clinical trials in non-infectious uveitis continued access to treatment with AIN457 while     collecting safety data and information on long term clinical use of treatment with AIN457.   "
149465|NCT01327651|"     Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of     antiretroviral (ARV) medications before exposure to HIV. This study will examine the     feasibility of different methods of dosing for a PrEP regimen. Three methods of delivery will     be compared: daily, time-based, and event-based.   "
149466|NCT01327638|"     The study is intended to provide additional post-marketing safety data regarding the use of     etoricoxib for the indication of ankylosing spondylitis.   "
149467|NCT01327625|"     [Study Objectives]        -  To evaluate the efficacy of azithromycin, N-acetylcystein, and inhaled corticosteroid          combination therapy in patients with bronchiolitis obliterans as a complication of          allogeneic hematopoietic cell transplantation in terms of response rate at 6 months          after treatment initiation based on the improvement of FEV1.   "
149468|NCT01327612|"     The purpose of this protocol is to allow continued treatment with conatumumab and/or AMG 479,     with or without chemotherapy to subjects without disease progression whose previous studies     were closed.   "
149469|NCT01327599|"     The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV®     from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle     glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).   "
149470|NCT01327586|"     Randomized clinical trial comparing a money management-based intervention involving storage     and management of client funds, substance abuse counseling, and risk reduction counseling to     individualized drug counseling.   "
149616|NCT01325662|"     This is a study to evaluate the feasibility and tolerability of low-rate continuous     Cerebrospinal Fluid (CSF) sampling and to estimate the number of participants who exhibit     severe baseline instability of CSF amyloid beta isoform Aß40 concentrations in healthy     participants.   "
149471|NCT01327573|"     This study is designed to assess the effectiveness of eculizumab in recipients of kidney     transplantation with donor-specific antibodies (DSA) and worsening kidney function and to     assess if eculizumab improves endothelial cell injury in the kidney.      The investigators hypothesize that complement inhibition with eculizumab will reduce     allograft injury, resulting from less complement-mediated injury of endothelial cells and     less endothelial cell activation.   "
149472|NCT01327560|"     Sleep quality is an important predictor of healthy status,quality of life and life span.     Sleeping problems affect 50%~80% in hemodialysis patients. Sleep quality and related factors     research in hemodialysis patients has been discussed and studied globally. Previous studies     show insomnia, excessive daytime sleepiness(EDS), sleep apnea syndrome(SAS), restless legs     syndrome(RLS) are major causes of poor sleep quality . There is few data to show the     influential factors related to sleep quality in Taiwanese hemodialysis patients.   "
149473|NCT01327547|"     To describe liver enzyme elevations in patients who are coinfected with HIV and either     Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with     their current suppressive anti-HIV drug therapy.   "
149474|NCT01327534|"     Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary     arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted     myocardium.   "
149475|NCT01327521|"     Primary Objective:      To compare the efficacy of TACE vs. CyberKnife SBRT in the treatment of locally recurrent HCC     after initial TACE.      Secondary Objectives:        1. To determine the progression-free survival of TACE vs. CyberKnife SBRT        2. To determine the overall survival of TACE vs. CyberKnife SBRT for locally recurrent HCC        3. To determine the toxicities associated with TACE or CyberKnife SBRT for the treatment of          recurrent HCC.   "
149476|NCT01327508|"     The objective of this study is to quantitate the amount of radiation both subjects and     surgeons are exposed to during intramedullary nailing of the femur using the TRIGEN SURESHOT     Distal Targeting System versus Standard nailing instrumentation.   "
149477|NCT01327495|"     The investigators will conduct a three-month, randomized, placebo-controlled trial comparing     the effects of increasing doses of androgen supplementation with Testosterone (T) gel on the     prostate in healthy men who are treated with acyline to block gonadal androgen production.   "
149478|NCT01327482|"     This study is an investigation of the pharmacokinetics of raltegravir in the tissue of the     female genital tract to determine if twice-daily dosing of 400mg achieves adequate drug     levels to prevent viral integration of HIV-1. The study will also assess whether drug levels     change in the tissue across the different phases of the menstrual cycle.        -  Hypothesis #1: Twice daily dosing with raltegravir 400mg will result in intracellular          concentrations that should be sufficient to suppress HIV-1 replication throughout the          menstrual cycle.        -  Hypothesis #2: Intracellular genital raltegravir peaks will be lower and troughs higher          compared to extracellular concentrations in the plasma and PMBCs (peripheral blood          mononuclear cells).        -  Hypothesis #3: Intracellular raltegravir concentrations will be slightly lower during          the luteal phase of the menstrual cycle due to cellular pumps such as p-glycoprotein,          which are present in higher numbers during periods of high progesterone.   "
149492|NCT01327300|"     The purpose of this study is to find whether treating patients with diarrhea predominant     Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help     improve their symptoms of diarrhea, bloating and abdominal pain.   "
149493|NCT01327287|"     This study is designed to analyze the use of early aggressive pain management with thoracic     epidural in eligible patients with blunt thoracic trauma.   "
149479|NCT01327469|"     The major soil-transmitted helminths (STHs), Ascaris lumbricoides (roundworm), Trichuris     trichiura (whipworm) and Necator americanus/Ancylostoma duodenal (hookworms) are amongst the     most prevalent parasites worldwide. An estimated 4.5 billion individuals are at risk for STH     and more than one billion individuals are thought to be infected, of which 450 million have     significant morbidity attributable from their infection, school-aged children in particular.     In this population infections cause stunting of the linear growth, anemia, reduce the     cognitive function and contribute to the existing malnutrition. In Jimma (Ethiopia), STH are     highly prevalent, affecting more than 60% of the children (data not published).      Current efforts to control STH infections involve periodic mass drug anthelmintic treatment     of infected children in endemic areas and are likely to intensify as more attention is     addressed to the importance of these neglected diseases. Monitoring drug efficacy in these     control programs has become indispensable in order to detect the emergence of resistance     and/or identify confounding factors affecting the drug efficacy. Recently a study has     evaluated a single dose albendazole (ALB) in school age children across 7 countries,     including Ethiopia, revealing that this regime is highly efficacious for the treatment of A.     lumbricoides (99.5%) and hookworms (94.8%), but not for T. trichiura (50.8%). For this     parasite a repeated dose regime of ALB on consecutive days is likely to be more appropriate.     Alternative drugs are mebendazole (single dose 500mg) and pyrantel+oxantel (single dose     10mg/kg), of which the latter holds promise as it can also be administrated to children     between 6 months and 2 years. The main objective of the present study, therefore, is to     assess the efficacy of 5 different treatment regimes against T. trichiura in schoolchildren     in Jimma, Ethiopia, including albendazole (1 x 400mg, 2 x 400mg), mebendazole (1 x 500mg, 2x     500mg) and pyrantel-oxantel (10mg/kg)+mebendazole (500mg).   "
149480|NCT01327456|"     Purpose: To determine the role health literacy plays in the care continuum for Chronic     Obstructive Pulmonary Disease (COPD) and the effect of a self-management intervention on     inhaler technique use, time spent on self-management, and knowledge for COPD patients with     low literacy.      Participants: The investigators will recruit patients from the University of North Carolina     at Chapel Hill Ambulatory Care Center (ACC) who have a diagnosis of COPD.      Procedures (methods): Potential subjects with COPD will be identified through pharmacy claims     data, clinic billing data and the electronic medical record. Eligibility will be prescreened     by a research assistant (RA) using the electronic medical record prior to approaching     potential subjects for consent. For the first part of the study, consenting subjects will     complete a baseline health literacy assessment, a questionnaire, an inhaler technique     assessment, and a diary of time spent in self-management activities. Pulmonary function tests     (PFT) will be performed on all participants for whom PFTs have not been conducted within the     previous 12 months. The questionnaire will include measures of COPD-related knowledge,     self-management techniques, quality of care, access, quality of life, costs, healthcare     utilization, exacerbations, and basic demographic information. The inhaler technique     assessment will be administered by the research assistant using a pre-established protocol.     The research assistant will abstract additional data from the medical record to assess the     quality of care based on adherence to recommended COPD care guidelines. For the second part     of the study, participants will be randomized to control and intervention arms. The     self-management intervention will be an interactive experience, delivered by a trained     research assistant, targeting self-management skills (inhaler use, using an action plan,     etc), smoking cessation, and exercise/pulmonary rehabilitation. Those randomized to the     control group will receive usual care. All participants will return 2-4 weeks after the     intervention for a follow-up assessment of inhaler technique, COPD-related knowledge, and     time spent in self-management.   "
149481|NCT01327443|"     The central hypothesis of this proposal is that a reduction in hepatic mitochondrial function     is the main pathophysiology behind NAFLD (Non-Alcoholic Fatty Liver Disease) and NASH (Non     alcoholic steatohepatitis). The investigators further hypothesize that lifestyle     modifications through aerobic exercise training without weight loss or diet-induced weight     loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content     and function in human subjects.      The investigators propose a randomized, controlled human clinical trial to compare the     effects of aerobic exercise training (without weight loss) versus diet-induced weight loss     (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH   "
153162|NCT01278979|"     This study aims to compare different midwife practitioners assessments of perineal tears.   "
149484|NCT01327404|"     The purpose of the study is to examine the relationship between brain structure and     depression in adults aged 30 or older with Diabetes. This relationship is determined using     magnetic resonance imaging technology (MRI), a scanner with a magnet that is used to create     images of the brain.   "
149485|NCT01327391|"     The aim of this study is to appreciate the tolerance of on line hemodiafiltration and its     impact on morbidity and cardiovascular risk factors in chronic renal failure patient.   "
149486|NCT01327378|"     The current study explores the incretin effect; a central mechanism of sugar metabolism.     People with type 2 diabetes have a markedly reduced incretin effect, while the incretin     effect never has been studied in patients with severe chronic renal failure. Non-diabetic     patients with severe kidney failure and patients with diabetes and normal kidney function     share several pathophysiological traits, including decreased sensitivity to insulin, fasting     hyperinsulinaemia and impaired beta cell function. The investigators expect the incretin     effect to be affected in patients with chronic renal failure without diabetes, which in time     can result in therapeutic changes in this group of patients.   "
149487|NCT01327365|"     Background:      The transradial approach is increasingly used in percutaneous coronary intervention (PCI)     because of lower major access site complications, lower bleeding risk and earlier patient     mobilization. According to this trend, in the last couple of years at the University Hospital     of Geneva the investigators have changed their practice and currently the transradial     approach is the most frequently used for PCI. However, the small diameter of the radial     artery remains a major limitation of the technique, especially in women or for complex PCI     necessitating larger bore guiding catheters. This may be overcome with sheathless guiding     catheters (Asahi, Japan), allowing for a standard inner catheter diameter (6-7 Fr), with an     outer diameter equivalent to a standard 5 and 6 Fr introducer sheath.      Aim:      This study is aimed to compare the transradial approach for PCI with a sheathless guiding     catheter and with a standard guiding catheter in women and patients with complex lesion     necessitating large bore guiding catheters.      Material and methods:      This prospective study will consecutively randomize all women and all men with     bifurcation/ostial lesion of a major coronary vessel (i.e. ≈ 120/year) in whom a transradial     PCI is attempted. The procedures will be performed either with a standard 6 or 7Fr guiding     catheter or with the sheathless 6.5, 7.5 Fr catheters.      End-points:      Successful performance a transradial PCI in all consecutive patients which qualify according     to the inclusion criteria (technical feasibility). Establish the proportion of procedures     performed with no device-related complications (safety). Analyze in details the technical     aspects of the sheathless catheter (efficacy).      Sample size:      The investigators have planed to include in the study ≈ 250 patients in two years. After 1     year of enrollment the investigators will perform an interim analysis and the instigators     will decide at that moment, according to the observed end-points, if prolonging the study     would be of any scientific value. In this case another 100 patients will be further included     in the study.      Enrollment time:      The investigators will start the study as soon the local ethical committee will give us the     permission. The investigators plan to start the study in July 2010. The end is expected for     July 2012.   "
149488|NCT01327352|"     The study will be a non-randomized, open label, single dose, placebo control, single center,     and single arm study in healthy subjects. The study will include one administration of     placebo and four single administrations of Oshadi D in two different dose levels,     administered in two feeding regimen for the evaluation of the influence of food on Oshadi D     absorption.   "
149489|NCT01327339|"     post-marketing surveillance to monitor safety and efficacy of ropinirole during using of     treatment for RLS   "
149490|NCT01327326|"     The aim of this proposal is to characterize pain inhibition in healthy controls and     Temporomandibular Disorder (TMD) patients with two models of endogenous pain modulation     (off-set analgesia; conditioned pain modulation), and to investigate the function of the     endogenous opioid system in these responses by using pharmacological blockade of the opioid     receptor.   "
149494|NCT01327274|"     This study is a Phase 3, multicenter, non-randomized study to evaluate the safety and     efficacy of the next-generation outpatient Magnetic Mini-Mover Procedure (3MP) in 15 patients     aged 8-14 years for the correction of pectus excavatum ('sunken chest'). 3MP for pectus     excavatum uses a magnetically coupled implant to pull the sternum forward and gradually     remodel the deformed costal cartilage. The Funding Source for this trial is the FDA Office of     Orphan Products Development (Grant #R01 FD003341).   "
149495|NCT01327261|"     A group of 24 healthy volunteers receive one tablet of an association of levodopa 200 mg and     benserazide 50 mg corresponding to two drug products: a test formulation (Evoser ®; Phoenix     S.A.I.C. y F., Buenos Aires, Argentina) and a reference formulation (Madopar ®; Roche Pharma,     Switzerland) to assess their relative bioavailability. After administration of each     formulation 17 blood samples are taken and levodopa is measured by HPLC. Pharmacokinetic     parameters (AUC, Tmax and Cmax) are compared.   "
149496|NCT01327248|"     The aim of this case-control study is the characterization of the bronchial and systemic     inflammation of children and young adults with bronchiolitis obliterans.      On the first visit subjects are asked to perform a lung function test (spirometry, body     plethysmography with helium). Further levels of eNO and eCO are determined. A blood sample is     drawn to describe the inflammatory status. Bronchial inflammation will be measured in induced     sputum. At the second visit, a non-specific bronchial provocation testing (PD20 FEV1     methacholine) is performed.   "
149497|NCT01327235|"     The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin     alone or Endostar alone in patients with malignant pleural effusion or ascites.   "
149498|NCT01327222|"     The purpose of this study is to compare the effectiveness of intravitreal bevacizumab     injection (IVBI) with respect to simple observation in patients with subfoveal choroidal     neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at     baseline with best corrected visual acuity (BCVA) less than 20/200.   "
149499|NCT01327209|"     Verify the following with blood glucose monitoring system:        -  precision and accuracy versus YSI reference        -  user evaluation        -  labeling comprehension   "
149617|NCT01325649|"     The objective of the study is to provide proof that a MRI based preoperative     radiochemotherapy in patients with locally advanced rectal carcinoma allows limiting RCT to     high risk patients without increase of locoregional recurrence rate and decrease of overall     survival provided there is a high quality of mesorectal excision.   "
149500|NCT01327196|"     The objective of this project is to study cognitive yields in people of the town of Salamanca     over 65, with particular emphasis on the acquisition of the initial symptoms of cognitive     impairment in order to detect mild cognitive impairment and study the relationship between     the clinical situation and cardiovascular risk factors. It will depart from a reference     population of 420 people older than 65 years living in the municipality of Salamanca which     took part in a survey prior to partner health needs of the elderly of 65 years in the     municipality of Salamanca. This was a stratified sampling as stratum considering the area of     health. The results of this study are expected to evidence the extent of the problem of     cognitive decline in the population over 65 years. It is also expected to determine the     relationship between the co-morbidity in this problem and specific factors of cardiovascular     risk in this group of population.   "
149501|NCT01327183|"     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety     of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing     percutaneous coronary intervention (PCI). Patients will be randomized to receive an     intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI.     Follow-up will be for 4 months.   "
149502|NCT01327170|"     The aim of this study was to evaluate safety and therapeutic response to micropulse diode     810nm laser treatment in patients with chronic central serous chorioretinopathy.   "
149503|NCT01327157|"     -  The purpose of this study was to evaluate the effects of Neuro Occlusal Rehabilitation          (RNO) in patients with peripheral facial palsy (PFP) disease, noting the decrease in          symptoms of masticatory dysfunction.        -  According to Carvalho (2009) patients with PFP have chronic unilateral masticatory          preference. Santos et al. (2009) in the same year noted that these conditions can lead          to problems with temporomandibular disorder.        -  Hypothesis- known that performing occlusal adjustment in these patients with chronic          PFP, ensuring a maximum of dental contacts and a final stop of the masticatory cycle          stable, providing a balanced occlusion.        -  dental cleaning was performed in two groups for the blind study        -  visual analog scale -To assess the quality of the oral functions of these patients, the          investigators applied the visual analog scale(VAS) and statistically evaluated the          degree of satisfaction regarding the functions of oro facial in relation to mastication          and temporomandibular dysfunction.        -  gnathostats models were made in the treatment group in the first and last query        -  occlusal adjustment in treatment group.In the group treated occlusal adjustment was made          in the teeth and applied a new (VAS) before and after treatment.      The RNO, is defined as a part of medicine that operates in stomatology occlusal plane as a     guide to a harmonious development of the face, chewing facilitating bilateral and     alternating. (Planas, 1997). It works through selective grinding on the occlusal platform,     providing an increased number of dental contacts.   "
149504|NCT01327144|"     Herpes Zoster is an infection that affects part of the nervous system caused by Varicella     Zoster Virus. Herpes Zoster manifests as vesicular eruption in the dermatome, often     associated with significant pain.      There are effective oral prescription antiviral medicines available to reduce the discomfort     of symptoms as famciclovir and aciclovir.      This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy     and safety of treatment with Famciclovir (500 mg) comparing to Aciclovir (400 mg) in patients     with Herpes Zoster.   "
149505|NCT01327118|"     The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of     brain vessels.   "
149553|NCT01326494|"     The purpose of this study is to investigate the benefits of giving filled prescription of a     medication to be used upon early onset of symptoms of URTI induced asthma. The hope is to     reduce the need to present to Health Care centres for treatment.   "
149506|NCT01327105|"     The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first     permanent birth control method that can be performed in the comfort of a physician's office     without hormones, cutting, burning or the risks associated with general anesthesia or tubal     ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix     without incisions. Over the next three months, the body forms a natural barrier around the     micro-inserts to prevent sperm from reaching the egg. Three months after the Essure     procedure, a doctor performs an Essure Confirmation Test. In the United States, this test is     called a hysterosalpingogram and evaluates the location of the inserts and whether the     fallopian tubes are blocked. Outside of the United States, a standard x-ray is performed to     evaluate the location of the inserts.      The purpose of this study is to evaluate whether a transvaginal ultrasound is an effective     method of confirming micro-insert location.   "
149507|NCT01327092|"     One aim of this study is to test the efficacy of the installation of multiple, passive     measures to reduce exposure to injury hazards in the homes of young children of first-time     mothers and reduce childhood injury. The study also seeks to identify sub-groups of mothers     and children who benefit most from the intervention and examine the potential moderating     effect of maternal depressive symptoms, the intensity of supervisory behavior, and child     temperament and activity, on the intervention and subsequent injury outcomes.      Specific Aim 1 Hypotheses:      H1.1: The housing units randomly assigned to the intervention group will have a significant     decrease in the number and density (number per area) of residential injury-related hazards     compared with control group units.      H1.2: Children who are randomized to the intervention group (e.g. installation of multiple,     passive measures to reduce exposure to residential injury hazards) will have a 50% reduction     in modifiable and medically-attended injuries compared with children in the control group     followed-up for 24-months in intention-to-treat analyses.      Specific Aim 2: Hypotheses H2.1: Persistent maternal depressive symptoms will moderate the     effects of the intervention on childhood injury in the home; households and children of     mothers with higher levels of symptoms will have more hazards and injuries.      H2.2: Children of mothers with less intense maternal supervisory behavior over the course of     the intervention follow-up will have higher rates of injury.      H2.3: Children scoring high in activity on the Carey Temperament Scale will experience     reduced benefits of the intervention on childhood injury in the home.   "
149548|NCT01326559|"     Study Objective:      Primary      1. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel,     Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with     intensity-modulated radiotherapy (IMRT).      Secondary        1. To determine the overall response rate.        2. To determine the locoregional and distant control rate        3. To determine the progression-free survival (PFS)        4. To determine the overall survival (OS)        5. To determine the safety of the induction chemotherapy and concurrent chemoradiation plus          Cetuximab.   "
149508|NCT01327079|"     This proposed investigation will test the following hypotheses: 1) Enzymatic activity of     CYP2B6 characterized by the formation clearance of methadone to EDDP (CLf,EDDP), is directly     related to both gestational and postnatal age; 2) variations in the CYP2B6 gene (SNPs) are     associated with variable activity of the CYP2B6 enzyme (as measured by the formation     clearance, CLf,EDDP), and 3) the elimination rate of methadone and its major metabolite EDDP     in neonates is dependent on the glomerular filtration rate and therefore on the stage of     development (defined by both gestational and postnatal age). The investigators propose to     develop a PK model for methadone dosing in neonates that takes into account both     developmental stage and genetic variability. The long-term goal of the proposed     investigations is to improve dosing of methadone in neonates exposed to opioids in utero or     post-natally, leading to improved control of their withdrawal syndrome and decreased adverse     drug reactions associated with the current use of methadone in these vulnerable patients.     More immediately, the investigators will develop a PK model for methadone dosing based on     relevant developmental and genetic characteristics. The acquired knowledge based on the     proposed study will lead to a more efficacious treatment of pain or opiate withdrawal     syndrome in newborn infants with a decreased chance of adverse drug reactions.   "
149509|NCT01327066|"     The purpose of this study is define the electrocardiographic (ECG) effects of Droxidopa at     clinical (600 mg) and supratherapeutic (2000 mg) doses compared with placebo and moxifloxacin     in healthy male and female subjects.   "
149510|NCT01327053|"     This study will assess the efficacy and safety of oral treatment with two dose levels of     LDE225 in patients with locally advanced or metastatic BCC.   "
149511|NCT01327040|"     Circadian rhythm disorders are a class of sleep disorders characterized by misalignment     between the timing of sleep and the timing of rhythms driven by the biological clock. Light     therapy can effectively treat these disorders, but the intensity and duration of light     exposure required to do so has limited its practical use. In this study the investigators     will test whether pre-exposure to dim light may enhance the response of the circadian system     to light therapy. If so, this could result in shorter treatments that would have greater     practical applications.   "
149512|NCT01327027|"     This research is being done because we wish to understand how a chemical produced in the     brain, vasopressin, effects emotional social communication processes. Understanding how this     system works in normal individuals may help us understand why some people, particularly those     with autism and/or antisocial personality disorder, have dysfunctional social interactions.      This study will test the effects of 3 doses of arginine vasopressin, delivered intranasally,     on physiological and behavioral responses to the faces of same- and other-sex individuals in     healthy men and women.   "
149513|NCT01327014|"     The purpose of this study is to demonstrate the efficacy of XueZhiKang to improve plasma     lipid profile, as compared to placebo, in outpatients with hyperlipidemia.   "
149554|NCT01326481|"     The purpose of this study is to determine the recommended phase 2 dose and overall safety and     tolerability of TRC105 when given in combination with capecitabine for the treatment of     patients with progressive or recurrent metastatic breast cancer.   "
149650|NCT01325220|"     There will be four study periods: Screening (up to 14 days in length), the Treatment Period     (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects     will be randomized to receive either STX209 (5 mg twice daily [BID], 10 mg BID or 10 mg three     times daily [TID]) or placebo. Efficacy,safety and tolerability assessments will be performed     periodically   "
149514|NCT01327001|"     Moderate and severe asthma bronchiale is treated by fixed combination (budesonide/formoterol     or salmeterol/fluticasone) in the Czech Republic.      There is a hypothesis that doctors should prescribe to each patients per year: six units of     fixed combination budesonide/formoterol, or seven units of fixed combination     budesonide/formoterol in approach SMART, or twelve units of fixed combination     salmeterol/fluticasone. With regard to current prices the treatment by fixed combination     budesonide/formoterol should cost less.      The investigators do not have any data about real life utilization of fixed combination in     asthma treatment in Czech Republic The investigators propose to conduct a non-interventional     multicentric retrospective epidemiological study looking into the patients records kept by     specialist - allergists and pulmologists.      Retrospective data for eligible patients will be reviewed by participating investigators,     physicians taking care of their patients, and recorded in the electronic CRF. Only patients     who have been treated for asthma bronchiale (classification of severity - moderate or severe     persistent asthma) with fixed combination for at least one year could be included into the     study. There are no scheduled visits for any patient participating in the study.   "
149515|NCT01326988|"     The traditional landmarks to locate the injection site and orientation of the spinal needle     for spinal anesthesia are based on palpation of surface bony landmarks. However the actual     injection target into the CSF is located at an unknown depth inside the patients 3     dimensional spinal anatomy which can itself vary in its orientation relative to these surface     markers.Also bony surface markers may not be palpable in some patients or the patient may     have altered spinal alignment. Thus an already blind procedure can become even more misguided     involving multiple trial and error needle insertions. On the other hand ultrasound allows     visualisation of deep target structures which are impalpable, it allows assessment of spinal     alignment and thus directs the orientation of the seeking needle more accurately. Performing     US in real-time during needle insertion gives continuous feedback about the correct needle     approach path which should reduce the number of blind needle passes.   "
149516|NCT01326975|"     In this study, the investigators want to observe how continuous positive airway pressure     delivered by two different modalities affects breathing pattern in small preterm infants.     Using a specialized feeding tube in the stomach, the investigators can measure and compare     how the diaphragm (a large breathing muscle) might be affected by those two modalities.   "
149517|NCT01326962|"     This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra     (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an     inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients     will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks     for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study.     Anticipated time on study treatment is 24 weeks.   "
149518|NCT01326949|"     Portal vein thrombosis (PVT) refers to an obstruction in the trunk of the portal vein. It can     extend downstream to the portal branches, or upstream to the splenic and/or the mesenteric     veins. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients.     Recent studies demonstrate that the presence of PVT is not only an independent predictor of     failure to control active variceal bleeding and prevent variceal rebleeding, but also     significantly associated with increased mortality in patients with liver cirrhosis.      However, in recent American Association of the Study of Liver Disease (AASLD) practice     guidelines and Baveno V consensus, no treatment strategies in cirrhotic patients with PVT was     clearly recommended due to the absence of randomized controlled trials.   "
149519|NCT01326936|"     This project seeks to develop a comprehensive, computer-based education program for primary     care physicians that will improve their skills in structured substance abuse screening, brief     interventions, and referral and treatment (SBIRT). The investigators will develop two online     education programs based on virtual patient (VP) technology. One program will include five     typical, interactive, problem-solving VPs and the second will include five identical VPs     except that two VPs will have been worked by substance abuse experts and presented as case     studies. The remaining three VPs will be unworked (typical VPs). The investigators     hypothesize that both education programs will significantly improve educational outcomes,     compared to no training, as measured by a validated survey tool. A secondary hypothesis is     that physicians using the worked (guided learning) program will achieve similar educational     results as those using the typical VP approach, but will require less training time.   "
149520|NCT01326923|"     This is an open label, single arm Phase II study of induction chemotherapy followed by     concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell     cancer (HNSCC) using monoclonal antibody cetuximab. Those patients with locally advanced     HNSCC deemed to be candidates for definitive concurrent chemo-radiotherapy will be treated     initially with 6 weeks of PCC (Paclitaxel, cetuximab and Carboplatin). This will be followed     by a week of no treatment for interim evaluation, followed by definitive concurrent     chemo-radiotherapy using 70Gy radiation with weekly cetuximab and cisplatin for 7 weeks. The     hypothesis of the study is that the use of cetuximab during induction chemotherapy followed     by cetuximab concurrent with chemoradiotherapy using low dose weekly cisplatin will improve     local control as well as distant spread.   "
149521|NCT01326910|"     This three week study will be conducted to determine the safety and efficacy of an     over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.   "
149522|NCT01326897|"     The purpose of the study is to learn how to make homes more supportive of healthy eating and     physical activity. As part of the study, participants will be randomly assigned to one of two     groups. One group will receive materials with information on healthy eating and physical     activity. The materials will be mailed 3 times over a 5 month period. The other group will     work with a coach to make their homes more supportive of healthy eating and physical     activity. Working with a coach involves 3 home visits and 4 coaching telephone calls over a 5     month period. This group will also receive materials by mail 4 different times. All     participants will be asked to complete 7 telephone interviews over a 1 year period.     Participants will also be asked to wear an accelerometer, a small portable device that tracks     movement from physical activity, for 7 days at 2 different points in the study.   "
149523|NCT01326884|"     A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day     information on use of the Zenith LP AAA Graft.   "
149524|NCT01326871|"     This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation     study of ALT-801 in a biochemotherapy regimen either containing cisplatin and gemcitabine or     containing gemcitabine alone in patients who have muscle invasive or metastatic urothelial     cancer of bladder, renal pelvis, ureters and urethra. The purpose of this study is to     evaluate the safety, determine the maximum tolerated dose (MTD) and the recommended dose     (RD), and assess the anti-tumor response of ALT-801 in combination with cisplatin and     gemcitabine or ALT-801 in combination with gemcitabine alone. The pharmacokinetic profile of     ALT-801 in combination with cisplatin and gemcitabine will also be assessed. The study     includes a dose escalation phase (Phase Ib) and a dose expansion phase (Phase II). Phase II     has two treatment groups, Expansion Group 1 and Expansion Group 2. Expansion Group 2 is for     platinum-refractory patients, consisting of two treatment arms based on the patient's renal     function. Patients will enroll to Expansion Group 2 after stage 1 of the Group 1 expansion is     complete.   "
149525|NCT01326858|"     The purpose of this study is to assess the ocular comfort and safety of olopatadine     hydrochloride opthalmic solution. 0.7%.   "
149526|NCT01326845|"     The objective of the study is to evaluate and compare the frequency and severity of GI     adverse events in different dose administration regimens. The patient population consists of     low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional     iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day     deferasirox or an evening dose of the same. Patients are then followed up for 6 months for     any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.   "
149527|NCT01326832|"     Using the traditional and hitherto used uncemented hip prostheses achieved good clinical     results, but one of the drawbacks is the risk of fracture in the femoral shaft in indbankning     of the prosthesis (1-2%). In addition, the bone scan demonstrated that in the years after     surgery dropped almost 30% of bone mass in the femoral shaft. This bone loss increases the     risk that in the years after surgery, the increased risk of fractures around the prosthesis     and in addition to impeding the described bone replacement prosthesis later.      The newly developed prosthesis is anchored in the femoral neck and thus not involve the     femoral shaft. This ensures a more physiological or normal weight transfer to the femur bone.      This contributes to bone mass in long large extent preserved in the years after surgery, so     you have a better opportunity later to make a new prosthesis surgery with good results. The     new prosthesis should be capable of simultaneously reducing the incidence of thigh pain in     the first year after surgery.`   "
149528|NCT01326819|"     Observational comparison study of three commercially available regional oxygen saturation     devices on a wide range of skin colors.   "
149529|NCT01326806|"     The purpose of this study is to test the efficacy of a parent-based intervention designed to     prevent adolescent sexual risk behavior in Latino and African American inner city youth. The     intervention will be administered in the context of mothers waiting for their children to     complete an annual physical exam required for school admission.   "
149549|NCT01326546|"     The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV) vaccine     (synthesized peptide) Joint entecavir treatment in chronic hepatitis B patients.   "
149550|NCT01326533|"     The purpose of this study is to determine the short-term effects of the antimalarial     medication, hydroxychloroquine (HCQ), compared with placebo using frequently sampled     intravenous glucose tolerance testing (FSIGTT) methodology to study changes in insulin     secretion and glucose tolerance in subjects at risk for developing Type 2 diabetes.   "
149530|NCT01326793|"     This study aims to determine whether using telecommunication tools, specifically web pages     containing online screening instruments and real-time video chat, will be an efficient way to     implement Major Depressive Disorder screening among college students. The study also aims to     determine if proactive depression screening and free online consultation with a psychiatrist     will increase the rate of help-seeking among college students with MDD.      Eligible participants will complete a demographics survey and depression screening assessment     online. Those subjects who express suicidality or depressive symptoms will be offered the     opportunity to complete a one-time psychiatric consultation with Skype video-conferencing.   "
149531|NCT01326780|"     A study to determine if three different doses of a new acne treatment are safe and better at     reducing facial acne than a treatment without active ingredient.   "
149532|NCT01326767|"     This study will be performed on grade IIIb and grade IV Non Small Cell Lung Cancer (NSCLC)     chemotherapy naive patients with good performance status. In course of this study, patients     will be treated with Paclitaxel in combination with either Cisplatin or Carboplatin in a     maximum of six therapy cycles. The goal of this study is to determine, if a pharmakokinetic     driven dose adaptation of paclitaxel leads to a reduction of of grade 4 neutropenia, compared     to conventional Paclitaxel dosing, without affecting progression free survival and overall     survival.      This study includes a biomarker analysis and an optional genetic substudy.   "
149533|NCT01326754|"     Background: Malaria is a cause of substantial morbidity and mortality in Malawi. Prompt and     effective treatment of uncomplicated malaria remains a key strategy to reduce the public     health burden of malaria. Due to the rising resistance to and falling efficacy of     sulfadoxine-pyrimethamine, the first-line treatment of uncomplicated malaria from 1993 to     2007, the National Malaria Control Program (NMCP) revised the national treatment guidelines     in 2007. The revised treatment guidelines recommend artemether-lumefantrine as the first-line     treatment for uncomplicated malaria and artesunate-amodiaquine as a second-line treatment for     uncomplicated malaria. The change in policy was based primarily on efficacy data from other     countries in sub-Saharan Africa. However, although both artemether-lumefantrine and     artesunate-amodiaquine have been in use in Malawi since 2007, there are relatively few     studies assessing their efficacy. In a study conducted in 2004-2006 in Blantyre,     artemether-lumefantrine was found to be efficacious.1 In addition, a more recent assessment     of artemether-lumefantrine in vivo efficacy conducted in six sites in Malawi in 2009 also     suggests that the standard formulation artemether-lumefantrine remains highly efficacious     (Kamija Phiri, personal communication).      Although, some Malawi-specific data on the in vivo efficacy of the standard formulation of     artemether-lumefantrine exists, there are additional data that is needed to support the     current policy and inform future policy decisions. In 2010 the NMCP has introduced the     dispersible formulation of artemether-lumefantrine (Coartem-D™) for use as a first-line     antimalarial in Malawi, due to the global unavailability of the standard formulation of     artemether-lumefantrine from Novartis, the key supplier of the standard formulation of     artemether-lumefantrine (Coartem™) in Malawi. In light of these developments, an assessment     of the efficacy, safety and tolerability of the dispersible formulation of     artemether-lumefantrine is warranted. In addition, the efficacy, safety and tolerability of     co-formulated artesunate-amodiaquine, the current secondline treatment for uncomplicated     malaria, has never been assessed in Malawi and should be evaluated. Lastly,     dihydroartemisinin-piperaquine has recently been added to the new World Health Organization     (WHO) guidelines for the treatment of uncomplicated malaria. This promising new antimalarial     might have a role as a first-line or second-line antimalarial for the treatment of     uncomplicated malaria, but there are no efficacy and safety data from Malawi. This knowledge     gap needs to be addressed to help inform policy makers about the potential role of     dihydroartemisinin-piperaquine for the treatment of uncomplicated malaria in Malawi.      Objective: Efficacy and safety of the dispersible formulation of artemether-lumefantrine,     co-formulated artesunate-amodiaquine and co-formulated dihydroartemisinin-piperaquine for the     treatment of uncomplicated Plasmodium falciparum malaria at Machinga District Hospital-     Malawi      Methods: An antimalarial drug efficacy trial will be conducted in Malawi. The participants     will be febrile people 6-59 months old with confirmed uncomplicated P. falciparum infection.     Patients will be sequentially allocated to receive treatment with either the dispersible     formulation of artemether-lumefantrine at a dose of 2/12 mg/kg body weight of artemether and     lumefantrine, respectively, per dose, given twice a day for 3 days; or co-formulated     artesunate-amodiaquine at a dose of 4 mg/kg/day artesunate and 10 mg/kg/day amodiaquine once     a day for 3 days; or co-formulated dihydroartemisinin-piperaquine at a dose of 4 mg/kg/day     dihydroartemisinin and 18 mg/kg/day piperaquine once a day for 3 days. Clinical and     parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug     effi¬cacy. The study will be conducted from January to December, 2011. The results of this     study will be used to assist the Ministry of Health in Malawi in assessing the current     national treatment guidelines for uncomplicated P. falciparum malaria.   "
149534|NCT01326741|"     Anaphylaxis is a serious allergic reaction that develops rapidly and can cause death. Some     patients experience anaphylaxis is association with exercise, a disorder called     exercise-induced anaphylaxis. A subset of patients with unexplained anaphylaxis, especially     those with hypotension during the anaphylactic episodes, have been shown to have abnormal,     clonal populations of a certain cell type, mast cells, in the bone marrow. This has been     described in at least one patient with exercise-induced anaphylaxis. The investigators would     like review the findings in a group of patients with exercise-induced anaphylaxis who have     undergone evaluation for the presence of abnormal, clonal mast cells.   "
149555|NCT01326468|"     Patients with advanced head and neck cancer is at high risk of recurrence at the primary site     or in the neck. Part of normal treatment is to treat such patients with chemotherapy and     radiation. The chemotherapy can include Erbitux. The purpose of this study is to treat such     patients with an additional agent, Torisel. This study tests the doses of Torisel that can be     safely administered together with radiation and chemotherapy.   "
149697|NCT01324609|"     The purpose of this study is to determine if the investigators can detect the presence of     choroidal nevi cells in the vitreous fluid of humans, as this may improve the diagnosis and     classification of choroidal nevi and melanomas in the future.   "
149535|NCT01326728|"     Background:      Allogeneic hematopoietic stem cell transplantation (or allotransplant; donor blood stem     cells) have been used with varying degrees of success as an immune therapy for blood-system     cancers (leukemias, myelodysplastic syndrome, lymphomas, multiple myeloma, etc.). Some people     s cancer remains active (comes back or continues to spread) after an allotransplant, while     other people s cancer disappears and they are hopefully cured . NIH researchers are studying     the reasons for these different treatment outcomes, and trying to develop better cancer     treatments for people with active cancer after allotransplant. Researchers are collecting     data from people who have had allotransplants for a cancer of the blood, whether or not the     cancer is in remission, and from their donors. Those with active cancers may be eligible to     participate in one of several NIH studies testing treatments for active cancer after     allotransplant.      Objectives:        -  To develop a systematic, comprehensive evaluation of individuals with relapsed malignant          blood cancers after allotransplant (and, if available, their donors) to identify          potential treatment study options        -  To compare the immune system after allotransplant between people whose cancers are          growing with people whose cancers remain in remission.        -  To compare the immune system after cancer relapse/progression treatment between people          whose cancer responds to treatment with those whose cancers continue to grow.      Eligibility:        -  Individuals whose blood system cancer grows or comes back after receiving allotransplant          treatment.        -  Individuals whose blood system cancer is responding or in remission 100 days or more          after receiving allotransplant treatment.        -  Related stem-cell donors of eligible allotransplant recipients.      Design:        -  Participants will be evaluated with a full physical examination, detailed medical          history (for recipients, including a history of allotransplant treatment process,          side-effects, etc.), and blood tests. Recipients will also have imaging studies,          possible tissue biopsies, quality of life questionnaires/assessments, and other tests to          evaluate the current state of their cancer, whether active or in remission. In some          cases, it may be possible to substitute results from recent tests and/or biopsies.        -  Healthy related donors will have apheresis to provide white blood cells for study and/or          for use in potential treatment options. If stem cells would be medically helpful to a          recipient, their donors might be asked to take injections of filgrastim before the          apheresis procedure to stimulate the production of stem cells for collection.        -  As feasible, all recipients will be asked to return to the NIH for detailed follow-up          visits in conjunction with 6, 12, and 24 months post-allotransplant evaluations, and may          be monitored between visits.        -  Recipients whose cancers are active and who are found to be eligible for treatment          protocols at the NIH will continue to be monitored on this study while participating on          treatment protocols. Return visits and follow-up tests for this study will be          coordinated with those required by the treatment protocol.        -  Participants may return in the future to be evaluated for new treatment study options          (recipients) or additional cell donations for therapy (donors).   "
149536|NCT01326715|"     Background:      - Contrast agents are drugs that make certain body areas or abnormalities show up better on     imaging studies, such as magnetic resonance imaging (MRI) scans. Mangafodipir is an MRI     contrast agent with manganese that has been approved for MRI scans of the liver and pancreas.     Because contrast agents with manganese have also been shown to be useful in studying problems     with the nervous system, researchers are interested in determining if mangafodipir may be     used for MRI scans of the brain or eye, two areas that often experience problems caused by     disorders that affect the nervous system, such as multiple sclerosis. However, more     information is needed on whether mangafodipir will be useful for this purpose, or how best to     use it in MRI scans of the eye and brain. To study mangafodipir more closely, researchers are     interested in studying its use in both individuals with multiple sclerosis and healthy     volunteers.      Background:      - Contrast agents are drugs that make certain body areas or abnormalities show up better on     imaging studies, such as magnetic resonance imaging (MRI) scans. Mangafodipir is an MRI     contrast agent with manganese that has been approved for MRI scans of the liver and pancreas.     Because contrast agents with manganese have also been shown to be useful in studying problems     with the nervous system, researchers are interested in determining if mangafodipir may be     used for MRI scans of the brain or eye, two areas that often experience problems caused by     disorders that affect the nervous system, such as multiple sclerosis. However, more     information is needed on whether mangafodipir will be useful for this purpose, or how best to     use it in MRI scans of the eye and brain. To study mangafodipir more closely, researchers are     interested in studying its use in both individuals with multiple sclerosis and healthy     volunteers.      Objectives:      - To evaluate the safety and effectiveness of mangafodipir in imaging studies of nerve     disorders affecting the eye and brain.      Eligibility:      - Individuals between 18 and 70 years of age who either have been diagnosed with multiple     sclerosis or are healthy volunteers.      Design:        -  Participants will be screened with a physical examination, medical history, and blood          tests.        -  Participants will have up to 10 outpatient visits for screening and MRI scans over a          period of up to 2 months. Participants will be divided into Eye and Brain groups, based          on which area will be studied during the scans. (Participants who have available time          may be eligible for study in both groups.)        -  Participants will have an initial MRI scan as part of the screening process.        -  At the first visit, participants will have a baseline MRI scan once before receiving          mangafodipir.        -  Participants will have up to five MRI scans, with the following procedures:        -  Eye imaging group: MRI scans will be scheduled at specific times between 2 and 48 hours          after receiving mangafodipir. Eye MRI participants will wear a dark contact lens and an          eye patch for 30 minutes before receiving mangafodipir, and leave both on for up to 8          hours. The other eye will remain uncovered.        -  Brain imaging group: MRI scans will be scheduled at specific times between 48 hours and          7 days after receiving mangafodipir.        -  Participants will have a follow-up MRI scan 1 month after receiving mangafodipir. This          scan is done to see how long mangafodipir may affect MRI images of the brain.   "
149537|NCT01326702|"     This phase I/II trial studies the side effects and the best dose of veliparib when given     together with bendamustine hydrochloride and rituximab and to see how well they work in     treating patients with lymphoma, multiple myeloma, or solid tumors that have come back or     have not responded to treatment. Veliparib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can     block cancer growth in different ways. Some find cancer cells and help kill them or carry     cancer-killing substances to them. Others interfere with the ability of cancer cells to grow     and spread. Giving veliparib together with bendamustine hydrochloride and rituximab may kill     more cancer cells.   "
149538|NCT01326689|"     This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and     safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose     titration in treating breakthrough pain episodes in adult cancer patients receiving strong     opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.   "
149551|NCT01326520|"     The aim of the study is to investigate the influence of a milk phospholipid enriched dairy     product on subjects with atopic dermatitis determining parameters of the immune status, the     plasma lipid profile and the skin texture.   "
158109|NCT01214434|"     The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in     cradle cap.   "
149539|NCT01326676|"     Medications that lower blood pressure and cholesterol are known to improve the shape and     function of our blood vessels. These improvements include a reduction in the thickness of the     wall of the carotid artery (the main artery that runs up the neck to supply the brain) and a     reduction in the stiffness of arteries generally including the main central artery -the     aorta. Such medications are in the polypill (the Red Heart Pill) that is being used in the     UMPIRE Study. In UMPIRE, patients' reported adherence to taking the single, once daily     polypill is being compared to adherence to medications taken as separate tablets (usual     care).The aim of the PESCA sub-study is to see whether or not the polypill differs from     'usual care' in its direct effects on blood vessels as shown by ultrasound examination of the     carotid arteries and assessment of central (aortic) blood pressure.   "
149556|NCT01326455|"     The purpose of this pilot study was to compare two devices and three methods for achieving     hemostasis after a transradial angiogram while assessing vascular complications and time     endpoints. The heart has traditionally been accessed through the femoral artery. However, in     the last 20 years, the radial artery has gained more popularity among physicians and     patients, thereby offering an alternative to the femoral approach. Various methods of     applying compression to the radial puncture site have been used, but no research has been     done to show what best practice is. In this case, best practice would be the most effective     way of getting hemostasis while limiting complications and ensuring the efficient use of     nursing and medical resources. It is hypothesized that statistically significant differences     are seen in time to discharge in the fast-release Terumo and Clo-Sur P.A.D. groups, as     compared with the control Terumo group, without increasing vascular complications.   "
149675|NCT01324895|"     The objective of this study is to compare the efficacy of prokinetics versus antibiotics     versus a combination of antibiotics plus prokinetics in the eradication of Small-Intestinal     Bacterial Over-Growth Syndrome (SIBO) in those with and without a positive D-xylose Breath     Test.      Hypothesis: Patients with SIBO treated with a combination of prokinetics and in particular     octreotide and antibiotics will have reduced recurrence rates of SIBO than either therapy     given alone.   "
149540|NCT01326663|"     Despite the body's natural healing during the first year after a head injury, many veterans     who have suffered even mild brain injuries find themselves easily upset or fearful as they go     about their daily lives. While these reactions to the world around them were easily managed     before the head injury, they now occur with little or no interruption and are exceedingly     difficult to manage. Such reactions include a sense of always being upset or fearful that     often makes it difficult to get along with family members, friends, coworkers, and employers.     This may lead to broken marriages, unemployment, and even homelessness.      Some people with head injuries try to manage their unmanageable moods by drinking alcohol     because it can create a sense of calm. However, alcohol's actions are short in duration. Most     find that they have to drink more and more for a similar calming effect, and they soon become     dependent on alcohol. This makes working and being part of their families even more     difficult.      To treat the unmanageable mood, we tried a medicine called valproate, one that eases mood     problems in people without head injury. We gave valproate to head injured persons with mood     problems in a non-blinded study where both the doctor and the patient knew that the     medicine was valproate and both were optimistic that it would work. In a small sample of     eighteen people, 85% found mood relief and most of those either stopped drinking alcohol or     drank much less than before. However, this might have been because both the doctor and     patient were hopeful that the medication would make the patient feel better or because the     medicine actually worked.      The only way to know for sure if the medicine works is to perform a study in which people     receive either valproate or a sugar pill while neither they nor their doctor know which one     they are taking. This is called a double blind study, as proposed here, and will involve     nearly three times as many head injured persons as the first study.      If it is successful, this study will show that valproate treatment helps head injured people     manage their moods and allows them to return to families, friends, and work. It will also     show that they drink alcohol less or not at all, improving their health even further. Then     doctors will know that they can use this medicine for large numbers of people who suffer from     head injury and help them to lead normal lives. If the outcome of the study shows that the     medicine works well, doctors can then use this medicine to treat people with head injury     immediately after the study results are published.   "
149541|NCT01326650|"     Despite significant therapeutic improvements, congestive heart failure (CHF) patients still     have a poor prognosis. Currently, 5-year survival rates are only 35-50%. There is an     accumulating body of evidence from prospective cohort studies that low circulating     25-hydroxyvitamin D is an independent predictor of all-cause and cardiovascular mortality,     respectively. Vitamin D deficiency is prevalent among CHF patients. We hypothesize that     vitamin D may improve survival in CHF patients. We therefore aimed to investigate whether     vitamin D supplementation reduces mortality and increases event-free survival in end-stage     CHF patients.   "
149542|NCT01326637|"     Human factors engineering literature makes clear that appropriate, well-designed and     well-timed information improves decision making and can reduce mental workload. Data from a     previous study showed that appropriate, well-designed and well-timed information is not     present in many primary care encounters with elderly patients. This puts primary care     physicians at risk of higher mental workload and poor decision making which can affect the     quality and safety of care delivered to patients. Elderly patients are at particular risk     because they are more likely to have more comorbidities, medications, and cognitive     impairments.      Dr. Karsh and his research team will test an intervention to improve the performance of     primary care physicians and, thus the safety of primary care of the elderly. The     investigators will use a randomized experiment, with random assignment at the level of     patient, to test and evaluate the intervention. The evaluation will involve 4 primary care     clinics, with 4 primary care physicians per clinic. The investigators will collect data from     768 patient visits pre-intervention and 1536 patient visits during the intervention.     Intervention patients will be randomly assigned to the intervention or care as usual.      The Intervention has two components:      Pre-visit care coordination:        -  5-7 days prior to a study patient's appointment with his/her doctor, the doctor's          nurse/MA will call the study patient and collect pertinent clinical information about          the patient using a data collection form the investigators call a Patient Overview          Document or POD.        -  The nurse/MA will ensure that any lab results, consultant reports, ER reports, imaging          studies, etc., that will be needed by the physician are available to the doctor.      Team Meeting:      On the day of the patient's appointment and prior to the beginning of the clinic session, the     nurse/MA will meet briefly with the doctor to jointly review the POD.      Hypotheses:      H1. Primary Care Physician (PCP): The intervention will increase situation awareness, reduce     PCP mental workload, reduce PCP perceived likelihood of error, and improve PCP visit     satisfaction. PCP efficiency, as measured by encounter problem density during a visit, will     also improve.      H2. Patient: The intervention will improve patients' perceptions of their visits on a variety     of AHRQ CAHPS measures, such as physician knowledge of patient history.      H3. Patient: The intervention will not impact the number or types of problems addressed     during the visit.      H4. Clinic: The intervention will not affect visit RVUs   "
149543|NCT01326624|"     The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use     in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a     high-risk for sudden cardiac death but are either not eligible for an implantable     defibrillator under current guidelines or are not able to receive the device due to their     condition.   "
149544|NCT01326611|"     The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of     ureaplasma urealyticum and prevention of chronic lung disease in premature infants with     birthweight < 1250 g and have ureaplasma urealyticum colonization.   "
149545|NCT01326598|"     The aim of the present study is to observe glycemic control, dose requirements, hypoglycemia     risk, other possible adverse effects and weight changes, as well as to compare these     parameters to prior treatment when patients with type 2 diabetes are initiated and treated     using V-Go during circumstances as close to normal clinical practice as possible.   "
149546|NCT01326585|"     Dexamethasone is a medication that has been shown to have clear anti-nausea,     anti-inflammatory, and painkilling properties. Dexamethasone is currently used to manage     postoperative symptoms of a variety of surgical procedures. However, its effect has not been     validated for scleral buckling surgery, which is used to treat retinal detachment, a medical     emergency that can lead to permanent blindness. In this study, the investigators will     randomly administer dexamethasone to half of scleral buckling surgery patients, and a placebo     to the other half. The investigators will then compare the postoperative symptoms of the two     groups in order to determine whether dexamethasone should be used for scleral buckling     surgeries.   "
149547|NCT01326572|"     HIV-infected patients have an increased incidence of emphysema compared to non-HIV-infected     patients, and it has been hypothesized that this accelerated disease progression is the     result of one or more latent infections that amplifies the pulmonary inflammatory response.     The investigators will examine the prevalence and progression of emphysema in subjects with     and without HIV and determine risk factors for emphysema in this population.   "
149581|NCT01326117|"     The investigators hypothesize that in adult patients with diabetic gastroparesis with Type 1     diabetes (HbA1c ≤ 10.5%), daily tadalafil use will significantly improve gastric emptying     compared to baseline as measured by gastric emptying time.   "
149552|NCT01326507|"     The patients presenting with acute pulmonary embolism and right ventricular dysfunction are     at high risk for life-threatening events and must be identified in the emergency department     for adequate care and hospital admission. Echocardiography can identify right ventricular     dysfunction, but this test is not always available, and echocardiographic criteria of right     ventricular dysfunction vary among published studies. The primary purpose of this protocol is     to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding     Protein) , to identify in the emergency department the patients presenting with high risk     pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac     biomarkers (BNP, troponin) and clinical score performances that have been previously studied     to stratify the prognosis of patients with pulmonary embolism in the emergency department.   "
149557|NCT01326442|"     The study will test the hypothesis that supplementing the diet of subjects with Metabolic     Syndrome with 2000 IU vitamin D and 1.8 g omega-3 fatty acids (EPA + DHA) per day, will     facilitate weight loss, improve body composition and reduce metabolic and biochemical risk     factors associated with type II diabetes and cardiovascular disease. Adult men and women who     meet the International Diabetes Federation criteria for Metabolic Syndrome will be enrolled     and embark on a 16 week diet and exercise intervention using a low glycemic index diet with     or without the supplementary vitamin D and omega-3. Subjects will be counseled weekly and     blood collected at weeks 0 and 16.   "
149558|NCT01326429|"     Hypo- and hypernatremia are the most frequent electrolyte disorders found in hospitalized     patients. The increasing use of diuretics and other medications influencing the water and     sodium homeostasis potentially lead to a rise in the prevalence of the electrolyte disorders.     Only little data is available on the frequency and the mechanisms leading to     hypo-/hypernatremia.      Thus, the investigators aim to A.) determine the frequency of hypo- and hypernatremia in the     emergency department of a large tertiary university hospital and B.) explore the mechanisms     leading to the development of dysnatremias by detailed clinical and laboratory examinations.   "
149559|NCT01326416|"     Android obesity contributes, via insulin resistance and endothelial dysfunction, to the     development of cardiovascular atherosclerosis. It leads to poor quality of life. It is often     associated with metabolic syndrome which includes, whatever the definitions used (National     Education Cholesterol Program, NECP / Adult Treatment Panel III, ATP III or International     Diabetes Federation, IDF), an increased waist measurement, an arterial high blood pressure     and disorders of the glucide and lipid metabolism. The treatment of the current epidemic of     obesity and metabolic syndrome in France (12.4 % of obese and 14 % of subjects with metabolic     syndrome) thus requires new therapeutic approaches.      A well-balanced diet and a daily physical activity are the indispensable requirements for the     treatment of obesity and metabolic syndrome. It is possible to associate it to     pharmacological agents, but the results are often partial and transient. Preliminary data     suggest that leucine or arginine supplementation could facilitate the loss of fat mass.     Moreover, the physical exercise has also demonstrated benefits.      Sessions of physical reconditioning (aerobic work + muscular intensification) associated with     a program of specific nutritional supplementation by a mixture of Leucine and Arginine (in     the daytime) could improve the treatment of obese subjects affected by metabolic syndrome.   "
149560|NCT01326403|"     This is a randomized controlled trial comparing the use of tranexamic acid to placebo in     patients admitted to hospital with a hip fracture.   "
149561|NCT01326390|"     Impact on contrast dose or total volume of contrast required to effectively treat the     targeted tumor.   "
149562|NCT01326364|"     The purpose of this study is first, to determine whether baseline perfusion characteristics     of pancreatic cancer, as characterized by CT perfusion studies, can predict tumor response to     treatment by stereotactic body radiotherapy (SBRT). The second goal of this study is to     determine whether baseline perfusion characteristics in those patients with resectable     pancreatic cancer correlate with immunohistologic markers of angiogenesis such as microvessel     density and vascular endothelial growth factor (VEGF) expression.   "
149563|NCT01326351|"     The purpose of this study is to demonstrate that prolotherapy in conjunction with a     physiotherapy program looking at reinforcing calf muscle and muscle of the plantar fascia,     relieves pain and improves function of people suffering of plantar fasciitis, an inflammation     of the plantar fascia, after basic treatment failure.   "
149564|NCT01326338|"     The purpose of this study was to determine the efficacy of nitazoxanide suspension compared     to placebo in treating prolonged diarrhea in children.   "
162259|NCT00002129|"     To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected     patients with CD4 count > 300 cells/mm3.   "
149565|NCT01326325|"     Long-term opioid therapy is commonly administered for the management of severe cancer pain.     Increasing doses of opioids are titrated against effects until analgesia is achieved or     intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor     antagonist, has been reported to improve analgesia in patients with uncontrolled pain     receiving high doses of opioids. This study aims at determining the effectiveness of ketamine     as an adjuvant to opioids in relieving cancer pain.   "
149566|NCT01326312|"     The purpose of this study is to determine whether GTx 758 is effective in achieving and     maintaining castrate testosterone levels in men with advanced prostate cancer.   "
149567|NCT01326299|"     The purpose of this study is to compare the postprandial glycemic response of subjects with     type 2 diabetes when consuming a meal along with beverages containing various combinations of     nutritional ingredients and fibers versus control beverage.   "
149568|NCT01326286|"     This study will primarily compare the effectiveness of surgery and radiation for localized     prostate cancer, the most common male cancer. It will focus on modern technologies and     control for differences in patients and treatments that may affect both cancer-related and     patient-reported outcomes (such as impotence and incontinence). By figuring out what     treatments work best, in which patients and in whose hands, it will help men with prostate     cancer make better decisions regarding their care.   "
149569|NCT01326273|"     The investigators will assess whether the infusion of autologous CMV-specific T-cells at the     time of CMV reactivation posttransplant will prevent worsening of CMV virus reactivation     posttransplant to a level that warrants therapy with antiviral drugs (objectively assessed by     looking at CMV virus copy number).   "
149570|NCT01326260|"     This study involved the medical record review of resuscitation records for all     severely-injured trauma patients requiring emergent surgical intervention and significant     acidosis from 2005 through 2009.   "
149571|NCT01326247|"     The purpose of this study was to evaluate the effects of Ischia thermal waters nasal     irrigation on allergic rhinitis and airway inflammation during the period of natural exposure     to parietaria pollen in children with allergic rhinitis and intermittent asthma.   "
149572|NCT01326234|"     The current study seeks to use a computer-based program to target parents of children who     smoke. Parents will be randomly assigned to either receive personalized feedback about their     smoking behaviors or not. One month after gathering their baseline information, all     participants will be asked to complete follow-up questionnaires online assessing their     smoking behaviors.   "
149573|NCT01326221|"     This open-label, non-blinded, pharmacokinetic (PK) study will assess both tenofovir and     emtricitabine (components of Truvada) concentrations within genital tract of male and females     after a single dose of Truvada®. Concentrations of the active drug will be measured in blood     (women and men), cervicovaginal aspirates and vaginal tissue (women only), seminal fluid and     rectal tissue (men only). Samples will be obtained at 24 hours (1 day), 48 hours (2 days), 5     days, 7 days, 10 days, and 14 days post-dose. Each subject will undergo 2 biopsy days, at     least 72 hours apart. Additionally, tissue samples will be evaluated ex-vivo for HIV     infectivity.   "
149574|NCT01326208|"     The purpose of this study in patients suffering from acute lung injury is to determine     whether positive end-expiratory pressure (PEEP) setting guided by electrical impedance     tomography (EIT) influences pulmonary gas exchange, lung mechanics, ventilation/perfusion     matching and homogeneity of regional ventilation when compared to other PEEP setting     strategies such as the open lung concept or the ARDSnet protocol.   "
149575|NCT01326195|"     This project is designed to develop and test a group-based preventive intervention to reduce     dating violence and sexual risk behavior among adolescent females with prior dating violence     exposure.   "
149576|NCT01326182|"     This study is to develop and pilot test a new group-based intervention for depressed Latina     mothers of children with asthma. The investigators ongoing work has identified that close to     50% of Latina mothers of children with asthma report significant symptoms of depression. The     intervention will combine asthma education and cognitive-behavioral strategies (e.g.,     increasing the pleasant activities that you do to help your mood) to address symptoms of     depression. The investigators hope to improve mothers' mood, their feelings of confidence     that they can manage asthma, and children's level of asthma control.      The project has two phases. In Phase 1, the investigators will develop the intervention by     working on the treatment manual and then conducting focus groups with Latina mothers to get     input on the intervention. The investigators expect 24 mothers at each of 2 sites (RI and PR)     to participate in focus groups (8 mothers per group). The group will take approximately 1-1.5     hours.      In Phase 2, the investigators will conduct a small pilot of the intervention at both sites     with new participants. At each site, 4 groups (4 sessions each) will be run. Participants     will have an equal chance of being placed in the new intervention condition (asthma education     and mood management), or in a control condition that covers asthma education and general     topics regarding child health and wellness (e.g., encouraging reading, reducing screen time,     nutrition). Participants will participate in a baseline research session, in the 4     intervention group sessions, and then in two follow-up research sessions (one at end of     treatment which is expected to occur two months after enrollment, and one at 4-months     post-treatment). They will complete survey instruments that assess their own depressive     symptoms, family demographic characteristics, access/barriers to health care, self-efficacy     to manage asthma, social network support, and family climate, as well as their child's asthma     symptom frequency. Children 7-12 are included only for the assessment of asthma symptoms and     lung function, which occurs at baseline, end of treatment, and 4-month follow up for 2 weeks     at each time point. Participation in Phase 2 is expected to take approximately 6 months.   "
149577|NCT01326169|"     The goal of this study is to reduce impaired driving, risky driving and alcohol-related     negative consequences among injured emergency department (ED) patients through a telephone     brief intervention. This study will allow researchers to test a novel method of brief     intervention that has the potential to be convenient and efficient mechanism to deliver an     intervention to an at-risk population. Eligible patients will be consented in the ED, will     receive an assessment and then will be randomized into one of two conditions: 1) telephone     brief intervention or 2) a comparison control group with a home safety educational program.     The participant will also receive an appointment for an initial telephone call. Both     conditions will be provided over three telephone sessions: the initial call (immediately     following randomization) and two booster calls at 2 weeks and 6 weeks after randomization.     Participants will provide information about their alcohol use, alcohol-related injuries,     impaired driving, and other driving related negative consequences at 4, 8, and 12 months     post-randomization.   "
149578|NCT01326156|"     This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral     osteoarthritis.   "
149579|NCT01326143|"     The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of     ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients with     severe Obstructive Sleep Apnea Hypopnea (OSAH) syndrome who refuse or are intolerant to     Continuous Positive Airway Pressure (CPAP) treatment.   "
149580|NCT01326130|"     CONTEXTE: L'Agence de la santé et des services sociaux de Montréal (ASSS) invited our     research team to evaluate the implementation of an integrated and interdisciplinary primary     care network for prevention and management of cardiometabolic risks (diabetes and     hypertension) (PCR). The intervention is based on the Chronic Care Model and the development     of an integrated services network. PCR is to be implemented in 6 territories of Centre de     santé et de services sociaux (CSSS). A first application for funding was made to Fonds     Pfizer-FRSQ-MSSS for an evaluation that has to be completed in the first 24 month after the     beginning of the implementation. This application to the PHSI program at CIHR is     complementary and will ensure an evaluation of the sustainability of PCR and of long term     effects (40 months after the beginning of the implementation) for patients and for their     primary care physicians.      In each CSSS, PCR plans for : 1- an interdisciplinary team in an education center working     with primary care physicians and offering to referred patients a pre-determined sequence of     clinical interventions over a 2-year-period; 2- a program supporting primary care physicians     (continuing education, documentation and clinical guidelines, referral system to second line     of care); 3- networking between actors of Réseau local de services (RLS) insuring clinical     information transfer required for efficient patient management.      OBJECTIVES: 1-evaluate PCR effects according to territory, time and degree of exposure     (specifically benefits to registered patients and support to participating primary care     physicians); 2- identify the degree of implementation of PCR in each CSSS territory and the     related contextual factors; 3- examine the relationship between the effects identified, the     degree of implementation of PCR and the related contextual factors; 4- assess the impact of     implementing PCR on the strengthening of RLS.      METHODS: The proposed evaluation will be done through a mixed design including two     complementary strategies. Using a quasi-experiment/before-after design, the first strategy     is a quantitative approach looking at the program effects and their variation between     territories. This analysis will use data from the PCR clinical database (ex.: HbA1c, BP,     lifestyle) and from patient questionnaire inquiring about care experience, utilization of     services, chronic care follow-up, self-management and quality of life. Around 3000 patients     will be enlisted. A primary care physician questionnaire will enquire about PCR effects on     their practice. Using primarily a qualitative and a case study approach, each of the 6     territories being one case, the second strategy will identify the degree of implementation of     PCR and the explanatory contextual factors. This analysis with use data obtained from     semi-structured interviews with program managers. The results of this analysis will be     summarized in a monograph for each territory. According to the type of indicator analyzed,     objective 3 will be fulfilled using linear models or longitudinal multilevel models     supplemented with an interpretive approach using the information from monographs and     discussion groups. The impact of implementing PCR on RLS will be assessed through interviews     with key informants.      RESULTS AND EXPECTED IMPACT: Our study will identify the effectiveness of PCR and contextual     factors associated with successful implementation and sustainability of PCR. Detailed     contextual information will allow application of our results to other environments that have     similar context and to other chronic conditions that could benefit from an integrated     services network.      KNOWLEDGE TRANSFER: Since decision makers, clinicians and researchers did and will take part     in all phases of PRC evaluation (planning, data collection, analysis and interpretation),     diffusion of information regarding the program is an integral part of the research process.     In addition, results will be presented at local, regional, provincial and national     conferences and published in reports and articles widely distributed. More specifically, a     regional symposium will be organized to share evaluation results with all CSSS in the region     (n=12) and with all our local and regional partners.   "
149582|NCT01326104|"     Immunotherapy is a specific approach to treating cancer that has shown promise in adult     patients for the treatment of melanoma, malignant brain tumors, and other cancers. The study     investigators will use the experience they have gained from these studies to try to improve     the outcome for children affected by a recurrent brain tumor.      This study will have two phases.      During Phase I, approximately 9 patients will be treated with increasing doses of     tumor-specific immune cells to determine the safety of this treatment. Phase I patients will     also receive dendritic cell vaccines to help boost the function of these immune cells and     maintain their growth.      During Phase II, approximately 35 patients will be treated with tumor-specific immune cells     and dendritic cell vaccines to see what impact they have on the tumor.   "
149583|NCT01326091|"     This is a parallel, randomized controlled trial comparing two types of patient positioning     and their effect on radiologic measures (pre-surgery visit, in the operating room prior to     surgery, at the conclusion of surgery, and at 3 weeks after surgery at patients'     postoperative visits) as well as surgeon satisfaction (prior to the end of the surgery) and     patient outcomes using patient self reported scales (pre-surgery, post surgery at 3 weeks     follow-up).   "
149584|NCT01326078|"     The purpose of this study is to compare the safety and efficacy of the of propofol     nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.   "
149585|NCT01326065|"     The purpose of this study is to study the implementation of laparoscopy-assisted surgery for     cure of colon cancer in daily surgical practice.   "
149586|NCT01326052|"     The aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve     or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that IMA     preservation could improve patient's quality of life reducing incontinence and/or     constipation rate.   "
149587|NCT01326039|"     Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine     5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically     analgesic effect after unilateral open inguinal hernia repair.   "
149588|NCT01326026|"     This trial is conducted in Europe and the United States of America (USA). The aim of this     trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in     insulin naïve subjects with type 2 diabetes mellitus when titrated using two different     self-titration algorithms (dose individually adjusted) in combination with metformin.   "
149590|NCT01326000|"     This randomized, multicenter, open label study will evaluate the safety and efficacy of     RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone     as second line treatment in patients with metastatic colorectal cancer. Patients will be     randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks     thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on     Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study     treatment is until disease progression or unacceptable toxicity occurs.   "
149591|NCT01325987|"     Using a randomized, placebo-controlled trial design in subjects with vitamin D deficiency,     the investigators propose to determine if vitamin D treatment improves glycemic control in     vitamin D deficient subjects with T2DM. The investigators hypothesize that oral vitamin D     treatment will improve glycemic control and ß-cell function in vitamin D deficient AA     subjects with T2DM. The investigators further hypothesize that maintaining serum 25(OH)D     concentrations above 20 ng/ml with oral supplementation of vitamin D will have additional     glycemic control effects.   "
149592|NCT01325974|"     Background: Antigen-detecting rapid diagnostic tests (RDTs) for malaria provide the     possibility of a parasite-based diagnosis in areas where good quality microscopy can not be     achieved.      P. falciparum tests targeting the histidine-rich protein (HRP2) antigen are generally more     sensitive than tests targeting the Plasmodium lactate dehydrogenase (pLDH) antigen. However,     as the HRP2 antigen is eliminated from the bloodstream more slowly than the pLDH antigen,     HRP2-based tests can give a positive result two weeks or more after the patient has taken an     effective treatment, while pLDH tests generally turn negative a few days after. The use of an     RDT positive result in a routine patient care is therefore challenged by the interpretation     of whether the result is due to a lasting effect of the already treated infection or to a new     infection. The interpretation might also be affected by the level of malaria transmission in     the area.      Objective: The objective of this study is to estimate the proportion of positive tests in     patients successfully treated for malaria (smear negative) at different time points in time     after treatment, for three rapid diagnostic tests: SD Bioline Malaria Antigen P.f. (catalogue     number: 05FK50-02-4), CareStart Malaria HRP2 (Pf) (catalogue number: G0141) and CareStart     Malaria pLDH (PAN) (catalogue number: G0111). The study will be carried out in two settings     with known low and high malaria transmission levels in order to provide guidance of     interpretation of a RDT positive result depending on the intensity of malaria transmission.      Secondary objectives will be to measure the sensitivity and specificity of the malaria rapid     tests compared to smear microscopy, to estimate the median time to become negative for each     of the tests and to estimate the proportion of positive tests and the median time to become     negative according to the initial parasitaemia and the presence of gametocytes.   "
149593|NCT01325961|"     The aim of the study is a medico-economic evaluation to estimate a cost differential between     three modalities of Intensity-Modulated Radiation Therapy for cancers of the prostate, cervix     and anal canal with pelvic lymph node irradiation : treatment with helical Tomotherapy and     dynamic arc therapy using two different technologies: RapidArc or VMAT.   "
149594|NCT01325948|"     The purpose of this study is to investigate the effects of Chronic Obstructive Pulmonary     Disease (COPD) on daily life activities in patients with COPD and also to determine the     socio-demographic profile, daily life style and needs of the patients with COPD.   "
149595|NCT01325935|"     A prospective multicenter registry in real-world Japanese patients undergoing DAPT for three     months after stenting. To assess the long-term safety of Endeavor Zotarolimus-eluting stent     through noninferiority in the primary endpoint between two different continuous regimen     (three and twelve months) groups of DAPT after stenting with Endeavor Zotarolimus-eluting     stent in real-world Japanese patients and to examine the optimal duration of DAPT after     stenting with Endeavor Zotarolimus-eluting stent. The long-term DAPT group in the present     clinical study (to be appropriated from the post-marketing surveillance of Endeavor) should     consist of consecutive patients undergoing DAPT for twelve months after stenting, while the     short-term DAPT group (to be newly registered in the present clinical study) should consist     of patients who are instructed to undergo DAPT for three months after stenting.   "
151071|NCT01306409|"     The purpose of this study is to gain information on reticulocyte neocytolysis in patients     treated with ESA with regard to different types of ESA.   "
149596|NCT01325922|"     Study Description The purpose of this study is to compare the defibrillation efficacy between     the 50/50% tilt biphasic waveform and the Tuned biphasic waveform utilizing High Voltage Lead     Integrity Check (HVLIC) impedance.      Hypothesis The Tuned waveform reduces defibrillation thresholds (DFTs) when compared to the     50/50% tilt waveform.      Study Methods        -  This is an acute, paired-sample, randomized (waveform testing sequence) study        -  Patients are implanted with an Food and Drug Administration (FDA) approved St. Jude          Medical (SJM) EpicTM+ DR/VR Implantable Cardioverter Defibrillator (or any other          standard output ICD after Epic+) and defibrillation lead system.        -  All study testing is completed at implant.        -  Patients are randomized to begin DFT testing with either the 50/50% tilt or Tuned          waveform.        -  The HVLIC feature is used to measure the high voltage lead impedance and to program the          Tuned and 50/50% tilt waveform pulse widths.        -  The DFT is determined by an optimized binary search method that is designed to reduce          the overall number of VF inductions to an average of 5.13 while maintaining very high          resolution and accuracy.        -  Total # of centers - 15 centers        -  Sample size - 60 patients   "
149597|NCT01325909|"     Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and     rectal) cancer is associated with improved survival, but also adversely affects physical     fitness, potentially rendering patients unfit for major surgery or increasing the risk of     adverse outcome (death and serious complications) after major surgery. The investigators have     pilot data using an upper gastrointestinal cancer patient cohort showing that neoadjuvant     chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The investigators     therefore propose a blinded, single centre, prospective interventional trial of patients     undergoing NACRT prior to elective colorectal cancer resection in an NHS teaching hospital.      The investigators wish to explore various hypotheses:        1. Is exercise intervention feasible and tolerable in this cohort of patients?        2. Can fitness be improved using a structured, responsive exercise training programme          (SRETP)?        3. Can SRETP improve quality of life?        4. Can SRETP improve physical activity?        5. Can SRETP improve surgical outcome?        6. Can physiological fitness and oncological outcome be matched to identify an optimal time          for physiological recovery following NACRT prior to major surgery.      The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30     patients for an interventional study over 24 months from Aintree University Teaching     Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed     to evaluate the ability of the muscle to take up and utilise oxygen, namely a cardiopulmonary     exercise test (CPET) and VO2 Kinetics tests, all done pre−CRT and at 3,6,9 and 14 weeks     post−CRT (pre−surgery). All patients will have their CPET, as well as standard restaging     scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data will also be     collected.   "
149624|NCT01325558|"     This is a Phase I, open-label, multi-center, competitive enrollment and dose-escalation study     of ALT-836 in combination with standard of care gemcitabine in participants who have locally     advanced or metastatic solid tumors. The purpose of this study is to determine the maximum     tolerated dose (MTD), and to assess the safety and pharmacokinetic profile of ALT-836 given     with gemcitabine. The clinical benefit, progression-free survival and overall survival of     study participants will also be assessed.   "
149598|NCT01325896|"     -  Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic          malignancies. Between 50 and 70% of symptomatic patients presented response to induction          chemotherapy. The rate of complete responses (CR) achieved with standard induction of          these treatments is less than 5% of cases and the median event-free survival between 2          and 3 years although most of the patients died from the disease.        -  High dose chemotherapy with autologous stem cell transplant has improved the response          rate and survival of patient with MM. However eventually all patients relapse with a          median EFS between 40-50 months post-transplant.        -  To improve these results and sustain remission, various maintenance treatment have been          proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits          in a meta-analysis.        -  Intron A s.c. need administration of 3 days per week and is not well tolerated        -  Recently a new formulation of Interpheron alpha2b is available. Conjugated with          polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in          MM.        -  The purpose of this study is to evaluate the role of Pegintron as maintenance after          autologous transplant in MM   "
149599|NCT01325883|"     Neoadjuvant chemotherapy (NAC) prior to surgery for upper gastrointestinal (oesophageal and     gastric) cancer is associated with improved survival. The investigators propose a prospective     blinded observational cohort study of patients undergoing NAC prior to elective upper     gastrointestinal cancer resection (oesophagectomy and gastrectomy) in three NHS teaching     hospitals. The investigators have pilot data showing that NAC reduces objectively measured     exercise capacity (fitness). The literature suggests that a lower level of exercise capacity     is associated with a high risk of adverse outcome (death and serious complications) after     major surgery.      The investigators wish to explore the hypothesis that decrease in exercise capacity (fitness)     associated with (NAC) prior to upper gastrointestinal cancer resection may outweigh the     benefits (duration of survival) achieved by NAC in some patients undergoing upper     gastrointestinal cancer surgery. The investigators aim to recruit 175 patients from over 36     months. Consenting patients will perform cardiopulmonary exercise testing (CPET) and complete     a quality of life questionnaire prior to and 4 weeks after NAC . Postoperative outcomes     measured at set time points will be objective recorded including mortality 1 year after     surgery and short term postoperative harm described by the PostOperative Morbidity Survey     (POMS) as well as Quality of life scores and resource use (e.g. hospital bed utilisation).     Exercise capacity (fitness) before and after NAC will be assessed using CPET and the     relationship between the derived variables (AT, VO2 peak) and clinical outcomes will be     described.   "
149600|NCT01325870|"     More than 300,000 Americans experience out-of-hospital cardiac arrest annually, with overall     survival rates averaging less than 5%. Low survival rates persist, in part, because manual     chest compressions and ventilation, termed standard cardiopulmonary resuscitation (S-CPR), is     an inherently inefficient process, providing less than 25% of normal blood flow to the heart     and the brain. Hemodynamics are often compromised further by poor S-CPR techniques,     especially inadequate chest compression and incomplete chest recoil. Active Compression     Decompression CPR (ACD-CPR) is performed with a hand-held device that is attached to the     patient's chest, and also includes a handle containing a metronome and force gauge to guide     proper compression rate, depth and complete chest wall recoil. The impedance threshold device     (ITD) is designed for rapid connection to an airway adjunct (e.g. facemask or endotracheal     tube) and allows for positive pressure ventilation, while also impeding passive inspiratory     gas exchange during chest wall decompression. Prior studies have shown that the combination     of ACD-CPR + ITD enhances refilling of the heart after each compression by augmenting     negative intrathoracic pressure during the decompression phase of CPR, resulting in improved     cardiac and cerebral perfusion. The intrathoracic pressure regulator (ITPR) is a next     generation inspiratory impedance therapy. The ITPR uses a regulated external vacuum source to     lower the negative intrathoracic pressure and is therefore less dependent on the quality of     CPR (e.g., completeness of chest wall recoil). The ITPR generates a pre-set continuous and     controlled expiratory phase negative intrathoracic pressure that is interrupted only when     positive pressure ventilation is needed to maintain oxygenation and provide gas exchange.      The purpose of the study is to compare the early safety and hemodynamic effects of S-CPR,     ACD- CPR + ITD, and S-CPR + ITPR in patients with out-of-hospital cardiac arrest.   "
149601|NCT01325857|"     This study was designed to investigate the analgesic effect of bilateral superficial cervical     plexus block in patients undergoing robot-assisted endoscopic thyroidectomy. The     investigators hypothesized that bilateral superficial cervical plexus blockade would reduce     the patient's pain score by more than 10 (on a VAS scale of 0~100) compared to a placebo     group and control group.   "
149602|NCT01325844|"     This study was designed to investigate the effects of epidural anesthesia combined with     general anesthesia during laparoscopic surgery. The investigators hypothesized that epidural     anesthesia will effectively block the activation of the sympathetic nervous system during     surgery, thus activating nitric oxide and reducing splanchnic ischemia and decrease in     postoperative renal function.   "
149603|NCT01325831|"     In order to explore the effect of repetitive TMS, which has shown to be effective in     intractable depression, we will examine resting-state, default-mode network functional     connectivity in patients with major depression. We will use a double-blind, sham-controlled     design. Our target sample size is 60(30 patients will be treated by active rTMS, the other 30     will be treated by sham rTMS). We will apply 10-day course of 10 Hz rTMS on left dorsolateral     prefrontal cortex of the subjects.   "
149604|NCT01325818|"     The purpose of this study is to compare the effects of pravastatin and rosuvastatin on     coronary plaque characteristics in patients with stable angina pectoris.   "
149605|NCT01325805|"     Overweight and obesity has been associated with a number of adverse pregnancy outcomes in     women of reproductive age, including infertility and early pregnancy loss. Recent data     suggests that overweight and obese patients are also at increased risk of recurrent pregnancy     loss (RPL), a devastating condition that affects 1% of the fertile population.      The investigators propose a prospective, randomized controlled trial in which overweight and     obese patients with unexplained recurrent pregnancy loss are enrolled in a structured, 6     month, weight loss program or provided routine counseling regarding the importance of weight     loss. Pregnancy outcomes will then be followed to assess miscarriage rates. Metabolic     outcomes, such as lipid and glucose profiles, will also be evaluated.   "
149606|NCT01325792|"     Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue     Reinforcement when used to reinforce midline fascial closure in single-staged open complex     ventral incisional hernia repair.   "
149698|NCT01324596|"     The aims of this study are:        -  To evaluate the benefits of the addition of bortezomib to standard rituximab with          cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP) therapy in Diffuse          Large B-cell Lymphoma (DLBCL).        -  To determine whether molecular phenotype effects the benefits derived from the addition          of bortezomib.   "
149607|NCT01325779|"     Study hypothesis: Subcutaneous enoxaparin is more effective than subcutaneous heparin in     preventing the development of DVT in the general surgical intensive care unit population.      Hospitalized patients are at increased risk for the development of blood clots in the legs,     known as deep venous thrombosis (DVT). Surgical patients are in a higher risk category than     the general hospital population due to a number of factors including undergoing surgery and     increased risk of immobility. The highest risk patients are in the surgical intensive care     unit, where their surgical risks for blood clots are combined with issues such as sepsis,     acquired blood clotting disorders, and increasing age, each of which are factors that     contribute to the risk of blood clot development. 1. Patients who develop these blood clots     (DVTs) are at risk for chronic leg swelling, pain, and in some cases, chronic ulcer     development on the leg. In the worst case scenario, these blood clots can break away and     migrate to the lungs where they cause a pulmonary embolism (PE), a clot in the lungs that can     cause significant breathing difficulty requiring intubation and mechanical ventilation, and     in some cases, death.      According to recent research, DVTs account for over 200,000 patient deaths each year     nationwide. 2. A large amount of data has supported the use of medication called heparin or     enoxaparin in low doses to prevent these blood clots from forming while in the hospital. Both     of these medications are considered standard of care for use patients considered moderate and     high risk for the development of DVT. 3. While both of these medications have been shown to     significantly reduce the occurrence of DVT in appropriate doses, 4. there has never been a     direct comparison of the two medications in the highest-risk population of the surgical     intensive care unit. Our own preliminary data suggests patients may have a lower incidence of     DVTs with the use of enoxaparin versus heparin. Part of the reason for this may be the     requirement for three times daily dosing of the heparin compared to once daily dosing for     enoxaparin. There may also be some inherent differences in the efficacy of the medications     themselves.   "
149608|NCT01325766|"     Cystic fibrosis (CF) is a lung disease that affects 30,000 children and adults in the US.     Incorporation of regular exercise into the lives of patients with CF is of interest because     it may improve lung function and quality of life. Yoga is an activity that may benefit     patients with CF in many ways including strengthening muscles of breathing, improving lung     function, and reducing stress which could improve quality of life and adherence to therapies.     Yoga has been shown to be beneficial in patients with other lung diseases such as asthma, but     has not yet been studied in CF.      The investigators hypothesize that yoga will be an activity that is safe and tolerable for CF     patients 12 to 25 years of age. The primary aim is to investigate the safety and tolerability     of an 8 week yoga program for patients with CF. The secondary aim is to determine the effect     of yoga on many aspects of CF disease including respiratory symptoms, adherence to regular CF     therapies, quality of life, lung function, exercise tolerance, and nutritional status.      The long-term goal is to use the data obtained in this study to design a future study of the     efficacy of yoga in a larger population of CF patients at multiple CF centers. This research     has the potential to influence the prevention and treatment of CF by providing data which     could be used to help understand the most appropriate and beneficial type of physical     activity for CF patients.   "
149609|NCT01325753|"     This pilot clinical trial studies the side effects of cryotherapy (cryoablation [CA]) in     treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.   "
149610|NCT01325740|"     The study will consist of a Screening period (up to 14 days), a Treatment period, and a     Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or     30 mg (or matching placebo) across four study centers.   "
149611|NCT01325727|"     The purpose of this research study is to find out more about smokers in recovery from     addiction to alcohol/other drugs, and to evaluate a brief computerized smoking behavior     feedback session. The hypothesis is that a brief computerized smoking behavior feedback     session will motivate more smokers to quit smoking than a control condition.   "
149612|NCT01325714|"     This study tests whether education about memory and pain might help to prevent aggression in     persons with dementia who have pain. The overall goal of this intervention is to reduce the     risk of aggressive behavior by improving several areas of patient life that are known causes     of aggression: pain, depression, lack of pleasurable activities, caregiver stress and     difficulty in caregiver-patient communication.   "
149613|NCT01325701|"     The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in     relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse     Large B-cell Lymphoma (DLBCL).   "
149614|NCT01325688|"     This study is primarily designed to investigate whether treatment, once daily for up to three     consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in     patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities.   "
149615|NCT01325675|"     The purpose of this study is to determine the effect of aerobic interval training in patients     with paroxysmal or persistent atrial fibrillation, especially to see if the burden of atrial     fibrillation and symptoms are reduced.   "
167909|NCT00037375|"     To investigate the relationship of childhood lifestyle and physical characteristics to     prevalent asthma.   "
149618|NCT01325636|"     The main purpose of this project is to evaluate the efficiency of the injection of CD4 and     CD8+ T cell anti-Cytomegalovirus (CMV) on blood viral replication of CMV, 21 days after the     first injection (adenovirus infection is not enough usual, especially in adults, to be used     for the primary purpose and is measured in the secondary endpoints).   "
149619|NCT01325623|"     The purpose of this study is to confirm cardiac-based seizure detection in Cyberonics Model     106 VNS Therapy System.   "
149620|NCT01325610|"     The assumption has been that 1,25(OH)2D is solely responsible for calcium absorption. That     has been one of the presumed causes of hyperparathyroidism in chronic kidney disease (CKD)     (low 1,25(OH)2D leads to decreased calcium absorption, which increases parathyroid hormone     release in compensation). Replacing 1,25 D directly has been the goal with using 1,25D or its     analogues in CKD. There is very little data concerning use of native vitamin D or 25(OH)D in     CKD, although autocrine functions in extrarenal tissues would use 25(OH)D. The latest KDIGO     guidelines do recognize the autocrine role of vitamin D, but have no data on outcomes or     doses or optimal levels to guide them and so have made a blanket recommendation to treat 25D     levels in CKD by general healthy population guidelines.        1. This project focuses on an outcome (calcium absorption) that may be impacted by          optimizing 25D status in renal patients. The investigators will assume for this project          that a level of 25D > 32 ng/ml is optimal in CKD patients as in a healthy population.        2. A secondary outcome is to quantify calcium absorption in CKD patients with and without          vitamin D repletion and to quantify systemic 1,25D levels. This may clarify the roles          25D and 1,25D play in calcium absorption.   "
149621|NCT01325597|"     The purpose of this study is to assess the effects of functional electrical stimulation     associated with inspiratory muscle training on functional capacity and quality of life in     heart failure patients.   "
149625|NCT01325545|"     About one-third of patients with stroke have no documented cause for the cerebrovascular     event (known as cryptogenic strokes). Atrial fibrillation is a common cause of stroke, but     when transient (paroxysmal) it may remain undiagnosed. Recent data suggest that occult     paroxysmal atrial fibrillation may be identified in patients with cryptogenic strokes using     prolonged ambulatory cardiac rhythm monitors.      The investigators designed this study pursuing the following goals:        1. To determine the prevalence of occult paroxysmal atrial fibrillation in patients with          cryptogenic stroke using long-term mobile cardiac outpatient telemetry.        2. To compare this prevalence to that found in a control group with stroke of known,          non-cardioembolic cause.        3. To look for clinical, laboratory, echocardiographic, and imaging data that serve as risk          factors for occult paroxysmal atrial fibrillation in patients with cryptogenic stroke.        4. To examine the utility of mobile cardiac outpatient telemetry, a relatively new          diagnostic tool, in the evaluation of patients with cryptogenic stroke.   "
149626|NCT01325532|"     The purpose of this study is to see if using Cranial Electrical Stimulation (CES) helps     improve symptoms of major depressive disorder (MDD). The investigators are studying the     device's effectiveness in treating depression, as well as its safety. This is a pilot study.      Eligible participants will be randomly assigned to receive either active CES or sham CES,     every weekday for 3 weeks. During the visits, subjects will receive CES or sham CES treatment     for 20 minutes.      The primary outcome measure will be change in score on the HAM-D 17. The secondary outcome     measure will be change in patient-reported sleep score.   "
149627|NCT01325519|"     The purpose of this study is to compare the decision making of hospitalized subjects having a     verbal discussion about CPR compared to subjects using a video.   "
149628|NCT01325506|"     Prostate cancer is the most common cancer in American men. Surgical removal of the entire     prostate (prostatectomy) is one option among the various ways to treat prostate cancer. The     use of robot assistance for prostatectomy has become common place, but its effectiveness has     not been compared to standard open prostatectomy in trials carried out at more than one     medical institution in which participants are identified and followed forward in time. Robot     assisted and standard open prostatectomy health related quality of life (HRQOL) outcomes have     not been compared in a prospective, multi-centered study. Prostatectomy can have side effects     that can change with time. This research study seeks to determine how common and how     long-lasting such side effects are; to find out what features of individual men's cancers and     what features of the treatments affect those side effects. This study also seeks to identify     factors that affect the quality of prostate cancer care by looking at how satisfied men are     with their prostate cancer care. Through these findings, this study aims to allow treatment     side effects to be anticipated more accurately for individual patients, and to provide a     means for determining the quality of prostate care.   "
149629|NCT01325493|"     The purpose of this study is to:      1. Establish whether ketamine can decrease opioid consumption and modulate the onset of     opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years     to 18 years, undergoing posterior spinal fusion and instrumentation.   "
149630|NCT01325480|"     The purpose of this acute study is to perform a preliminary investigation of high septal     right ventricular pacing in the vicinity of the His bundle region as an alternate or     adjunctive means for cardiac resynchronization in patients with heart failure and wide QRS.   "
149644|NCT01325298|"     The primary objective of this study is to evaluate two different ultraviolet (UV) dosing     regimens for corneal collagen cross linking to slow the progressive changes in corneal     curvature in eyes with progressive keratoconus or post-refractive surgery ectasia.   "
149631|NCT01325467|"     This will be a registry study that will enroll patients referred for an ECG treadmill test     with nuclear myocardial perfusion imaging (MPI). The high frequency QRS (HFQRS) information     will be recorded and analyzed automatically and simultaneous with the standard ECG signals by     the HyperQ System. Results of subsequent tests performed on each patient will be collected     and used to enhance the reliability of designating each patient as a CAD-negative (i.e., no     significant coronary artery disease) or a CAD-positive (i.e., significant coronary artery     disease).   "
149632|NCT01325454|"     Angiogenesis is a key process in the formation of exudative pleural effusions. Fluid     loculation is common in parapneumonic effusion and is associated with depressed pleural     fibrinolytic activity and poor clinical outcome. However, the relationship between angiogenic     cytokines and fibrinolytic activity in the pleural space remains unclear. The researchers's     hypothesis is that the levels of angiogenic cytokines were increased and associated with     decreased fibrinolytic activity in parapneumonic effusions which may contribute to fibrin     deposition and fluid loculation in the pleural space.   "
149633|NCT01325441|"     This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608     in combination with paclitaxel in patients with advanced malignancies.   "
149634|NCT01325428|"     The general aim of this study is to investigate the efficacy and safety of afatinib alone and     in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy     within this trial) as treatment in patients with HER2-overexpressing, locally advanced or     metastatic inflammatory breast cancer. The study will include patients who have and have not     failed prior trastuzumab treatment.   "
149635|NCT01325415|"     The purpose of this study is to evaluate the effects on QTc interval in healthy males when     administered a single dose of NKTR-118 compared with placebo and moxifloxacin. (QTc is a     specific time interval that can be measured in a heart beat by taking Electrocardiogram     (ECG))   "
149636|NCT01325402|"     In this study different mass of the radioligand AZD4694 will be given to patients with     Alzheimer's Disease and healthy volunteers to evaluate wich Mass of AZD4694 that gives the     best opportunities for following disease progress and treatment effects.   "
149649|NCT01325233|"     Astragalus membranaceus (AM) is used to treat stroke for a long time, and a number of studies     have shown that AM can reduce cerebral infarction area and has anti-oxidation activity. PG2,     a sterile powder of polysaccharides isolated from the root of astragulus (Huang-Chi) for     intravenous injection, has been approved as a botanical drug by TFDA. Hemorrhagic stroke will     induce secondary peri-blood clot edema and that may increase intracranial pressure to     exacerbate clinical symptom. Therefore, the purpose of the present study was to investigate     the efficacy of PG2 on hemorrhagic stroke.   "
149637|NCT01325389|"     Menopause is the milestone of a more broaden condition that can last up to 10 years. The     first menopausal symptoms usually appear around the age of 42 and are characterized by a     gradual decline in thyroid and gonadal function with a progressive increase of plasmatic     luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels.      Recent studies have shown that myo-inositol and melatonin play a major role in ovarian     homeostasis. In particular, it has been demonstrated that myo-inositol and/or melatonin     supplementation lead to an increase of oocyte quality.      Additional studies focused on postmenopausal women have shown that myo-inositol is able to     ameliorate the metabolic syndrome that often affects these patients, thus reducing the risk     of cardiovascular diseases (CVDs).      The aim of the present study is to evaluate whether myo-inositol and melatonin might play a     positive role in regulating hormonal levels during menopausal onset.   "
149638|NCT01325376|"     This is a six month lifestyle management study to compare the effects of iWell; a dynamic     online interactive technology to a self-directed program in overweight or obese individuals.      The primary aim is to test the hypothesis that dynamic online interactive technology     intervention is more effective than self-directed program in obtaining and maintaining weight     loss and other biometric improvements.   "
149639|NCT01325363|"     The aim of this research is to investigate the neurolinguistic mechanisms underlying thought     disorders among schizophrenic patients. In particular, it will investigate the     neurolinguistic basis for loose association - a phenomena which this population is     characterized by. Several researchers have previously suggested that loose associations among     schizophrenic patients relate to a lack of inhibition in the automatic spread of activation     mechanisms within semantic networks (e.g., Soriano, Jimenez, Roman, & Bajo, 2008). This     research focuses on the relationship between I. the left-right hemisphere dynamic and II.     semantic processing, among schizophrenic patients. The research follows Jung-Beeman's (2005)     model which relates semantic associations, activation and inhibition processes to the     functioning of the two cerebral hemispheres.      Previous research suggests that, when compared to the neurotypical population, people with     schizophrenia show a less defined - or even reversed - hemispheric lateralization pattern for     semantic processing. This is linked to an impairment in language function in the left     hemisphere, and to a language functions shift from left to right hemisphere (e.g., Crow,     1997). The investigators assume that this unique lateralization pattern may cause a change in     balance in the semantic activation and inhibition system among schizophrenic patients.      As stated, one of the linguistic models that predicts how reduced left hemisphere dominancy     will influence linguistic functioning is Jung-Beeman's (2005) bilateral model for language     understanding. According to this model, the left hemisphere specializes in precise and fine     semantic processing, while the right hemisphere specializes in coarse and abstract semantic     processing. Building upon this distinction, our assumption is that schizophrenic patients     experience a difficulty in fine semantic processing which is caused by functional impairment     in the left hemisphere. It is our further assumption that coarse semantic processing -     located in the right hemisphere - is relatively unimpaired. This change in the balance     between the two processes may have direct implications on the associative semantic network     among schizophrenic patients.      In order to test this hypothesis, the current research will make use of a specific language     expression type which involves fine and coarse semantic processing, and for which there is     evidence for crucial right hemisphere involvement: novel metaphor processing. 10-20 adult     schizophrenic patients will be presented with four different types of two word expressions:     literal; conventional metaphor; novel metaphor and unrelated. The patients will have to     decide as quickly and accurately as possible if the expression is meaningful or meaningless     while their brain activity is recorded by a Magnetoencephalographic (MEG) device (which     combines a high temporal resolution with the ability to localize the activity).      Therefore, our main hypothesis is that schizophrenic patients will show a bilateral brain     activity pattern when conducting semantic decisions, and that this pattern will be related to     improved reaction times and accuracy when presented with novel metaphors than when presented     with other types of expressions.   "
149640|NCT01325350|"     This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared     with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern     hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil     2% solution which will be provided open-label.   "
149641|NCT01325337|"     This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared     with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic     alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5%     solution which will be provided open-label.   "
149642|NCT01325324|"     In different cases intraocular pressure (IOP) have to measured in lying position. Therefore a     lot of portable tonometers have been established. The Icare Pro is a new tonometer on the     market that allows faster and more comfortable IOP-measurements. No local anesthesia is     needed, what is a major advantage for the patients. In this study the investigators want to     evaluate if IOP measurements with Icare Pro Tonometer are as reliable as they are with other     established portable tonometers (Perkins, TONO-Pen and hand held-Dynamic Contour Tonometer).        -  Trial with medical device   "
149643|NCT01325311|"     This randomized phase II trial studies cholecalciferol and genistein compared to placebo in     treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow     the growth of cancer cells and may be an effective treatment for prostate cancer.   "
149646|NCT01325272|"     To verify the occurrence of Spontaneous Otoacoustic Emissions (SOAE) in neonates at term and     preterm infants who had transient otoacoustic emissions and verify if the presence of     response is related to gestational age, gender or risk factors for hearing loss.   "
149647|NCT01325259|"     Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a     major matter of concern. There is now an important body of literature stating that early     isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing     AD. Several biomarkers are now available : specific and sensitive neuropsychological     assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI,     cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain     glucose hypometabolism in temporo-parietal regions with PET [F18]FDG. However, PET imaging     using labelled compounds specifically binding to APs has been suggested to improve the     diagnostic reliability and to potentially help in shortening the delay until formal clinical     diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to 15     minutes acquisition 50 to 60 minutes post injection.      Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD,     MCI patients and Healthy Controls.      Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will     have convert toward dementia versus those who will not, at two year follow-up period, to     compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG     hypometabolism, ApoE genotype.      Method: Prospective multicentric study. 65 patients expected to enter the study.      Primary outcome measure: Standard Uptake Volume ratios.   "
149648|NCT01325246|"     The risk for recurrence after ventral hernia repair is often based on reoperation rates with     short follow-up rather than recurrences identified by clinical examinations.      The purpose of current study is find the real incidence of recurrences 3 years after ventral     hernia repair and to compare with the reoperation rate.   "
149699|NCT01324583|"     Primary Objective:        -  To assess the tolerability at global doses      Secondary Objectives:        -  Safety        -  Pharmacokinetics        -  Efficacy   "
149700|NCT01324570|"     The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients     of ages 7 to 16 years.   "
149651|NCT01325207|"     The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of     cancerous tumors that are HER-2 positive. Patients are being asked to participate in this     study because they have been diagnosed with having tumor cells in their spinal fluid. This     study will investigate the safety and effects of this drug when given directly into the     spinal fluid.      Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the     Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer The purpose of this     research study is to determine a safe dose of the drug Trastuzumab and then determine how     effective this treatment is.   "
149652|NCT01325194|"     The purpose is to test whether early central nervous system (CNS) prophylaxis given at the     beginning of therapy for young high risk diffuse large B-cell lymphoma (DLBCL) patients is     feasible and could reduce the risk of CNS relapses. Early CNS prophylaxis with two courses     high dose methotrexate (HD-MTX) in combination with     rituximab-cyclophosphamide-doxorubicin-vincristine-prednison (R-CHOP) is followed by four     courses of R-CHOP14 and etoposide (E) and one course of HD-Ara-C. In addition the patients     will receive three courses of liposomal cytarabine intrathecally. The results will be     compared to a recent Nordic CRY-04 study. Shifting of CNS prophylaxis to the beginning of the     therapy offers a potential to overcome the subclinical disease and thus reduce the risk of     early clinical CNS recurrence. As flow cytometry (FCM) can improve the sensitivity for     detecting occult leptomeningeal disease over cytology , FCM from cerebrospinal fluid will be     incorporated into the staging procedures.   "
149653|NCT01325181|"     The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab     injection versus low-fluence PDT in the treatment of chronic CSC.   "
149654|NCT01325168|"     Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the     hypothalamus - is a key mediator of complex social and affective behaviors, including     emotional empathy. Recently, several theoretical studies suggested that PTSD patients have     abnormal functioning of the OT system. According to these theories, dysfunction in the     oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and     therefore intranasal OT may potentially relieve these symptoms. The main goal of this study     is to examine the effects of administration of nasal OT on empathic abilities among PTSD     patients. Another goal of this study is to examine the relationship between empathic     abilities and the ability to retrieve autobiographical memories among PTSD patients.   "
149655|NCT01325155|"     The association between exposure to ambient air pollution and pulmonary disease has been well     established.To date no study has assessed the burden of cardiovascular disease in Israel and     its relation to ambient air pollution.      The Haifa Bay Area has a long history of industrialization including possessing the nation's     largest oil refineries, oil-fired power plant, agrochemical and cement producers, industrial     incinerators and the Eastern Mediterranean's busiest port. The presence of industrial and     mobile sources, combined with a basin effect has contributed to air pollution in the Haifa     Bay Area and has raised concerns about potential health effects.      Research Objectives        -  Determine if the increased rate of cardiovascular mortality in Haifa is associated with          PM 2.5 concentrations.        -  Assess effect modification in diverse sub-populations.        -  If an association does exist, assess the economic burden of PM 2.5 associated          cardiovascular morbidity and mortality.        -  Design prediction models of daily cardiovascular emergency department visits based on          daily and seasonal variation of air pollution.   "
149656|NCT01325142|"     This study seeks to identify risk factors associated with the development of a jaw condition     seen in patients with cancer treated with certain medications.   "
149657|NCT01325129|"     Most Clavicular Fractures in Children can be Treated Conservatively. Our Own Study showed a     Benefit towards Much Lower Pain and Better Cosmesis in Adolescents when Treated with Elastic     Stable Intramedullary Nailing.      The First 20 Patients Treated with this Method will be examined for Functional (CONSTANT and     MURLEY-Score) and Cosmetic Results as well as Ultrasound-Morphology of both clavicles and     Patients`satisfaction (CSS-8). Further on, all complications and problems will be documented.   "
149658|NCT01325116|"     ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack     constituting approximately 30% of all cases. Clinical guidelines around the world support the     prolonged use of secondary preventative medications including aspirin, clopidogrel, statin,     beta-blocker and angiotensin blockers with the highest recommendations. While in-hospital and     discharge prescription rates are excellent, adherence to these essential life-saving     medications is far less than ideal, even a few months following hospital discharge. The     investigators plan to capitalize on the existing structure of the SMART-AMI project already     underway in LHIN IV to undertake a randomized controlled trial evaluating a reminder sent on     behalf of the interventional cardiologists, delivered by mail, at 1, 2, 5, 8, and 11-months     post-discharge, reviewing the evidence for life-saving cardiac medications and urging     long-term adherence to secondary preventative cardiac medications. This will be sent to the     family physician and the patient, using audience-appropriate language. If the DERLA-STEMI     project is accepted by physicians and patients, found to be both feasible and effective, then     this simple and low-cost intervention will be studied in all patients with an abnormal     coronary angiogram.   "
149659|NCT01325103|"     This research investigates the use of autologous bone marrow stem cells in patients with     spinal cord injury.   "
149660|NCT01325090|"     Botulinum toxin type A has been reported to inhibit the release of various pain     neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process     that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This     action is probably responsible for the analgesic effect of botulinum toxin type A recently     demonstrated in patients with neuropathic pain of peripheral origin.In those studies,     patients had been suffering for years. The investigators can hypothesizes that earlier     administration of Botox in the course of neuropathic pain might prevent central     sensitization, that is secondary to peripheral sensitization. The investigators can hope to     increase efficacy of Botulinum toxin type A injections and to prevent chronification of pain.   "
149661|NCT01325077|"     Can a nurse-based, anesthesiologist-supervised model reduce prevalence of postoperative pain     in pediatric patients?   "
149701|NCT01324557|"     The aims of this study are to assess the potential efficacy and safety of insulin pump to     improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for     diabetic continuous ambulatory peritoneal dialysis (CAPD) patients.   "
149662|NCT01325064|"     Background: The purpose of this study is to analyze the relationship between central and     peripheral blood pressure (clinic and ambulatory) with vascular structure and function,     assessed by carotid intima-media thickness (IMT), artery venous retinal index, pulse wave     velocity (PWV) and ankle-brachial index in patients with diabetes type 2 and without diabetes     type 2. Develop and validate a software to measure the retinal vessels and to estimate     arterio-venous index automatically.      Methods/design: The investigators will Perform a coss-sectional study with control group,     with follow-up of 4 years in primary care. The study population will be diabetic type 2     patients with a control group without diabetes mellitus. The investigators will include by     consecutive sampling 300 patients between 34 and 75 and without previous cardiovascular     disease, half of each group. Main measurements: age, sex, height, weight and waist     circumference. Lipids, creatinine, microalbuminuria, blood glucose, HbA1C, insulin,     fibrinogen, hs-CRP and markers of endothelial dysfunction. Clinic and ambulatory blood     pressure (MAPA). Ultrasonography to assess carotid IMT, retinography to assess arterio-venous     ratio. ECG to evaluate left ventricular hypertrophy, ankle-brachial index and morphology     analysis (PWA) and pulse wave velocity (PWV) in Sphigmocor System.      Discussion: The investigators provide information regarding various parameters derived from     MAPA and pulse wave analysis of with target organ damage, especially with the vascular     structure and function assessed by IMT and PWV and endothelial dysfunction in patients with     diabetes type 2 and without this disease. The investigators also hope to demonstrate the     usefulness of the tool developed for automatic evaluation of retinal vascularization in the     early detection of abnormalities of vascular structure and function and the prognosis of     cardiovascular disease in the medium term.   "
149663|NCT01325051|"     The purpose of this study is to characterize the way the first commercially available     integrase inhibitor, raltegravir, a new class of antiretrovirals that is used to treat HIV,     is distributed into the rectal mucosal tissue. This information will generate important     information regarding the drug's penetration into lymphoid tissues that are rapidly depleted     in HIV infection. Subsequently strategies to prevent the sexual transmission of HIV and for     treating HIV-infected individuals will be designed.   "
149664|NCT01325038|"     Healthy males are randomized to isometric exercise for three months with either extra protein     or extra calories in the form of a fast food meal/day in order to study if increase in muscle     mass increases resting metabolic rate and if this is affected by presumed increased caloric     intake as compared with only proteins.      Body-composition was measured with Dual-Energy X-ray Absorbimetry (DEXA) and RMR was measured     by registration of CO2 production and O2 consumption.   "
149665|NCT01325025|"     High-field MRI and diffusion tensor imaging with 3D reconstruction of the myelin tracks, in     combination with multivoxel proton spectroscopy, will allow to precise more accurately the     evolution of the white matter lesions in patients affected with Metachromatic Leukodystrophy     (particularly in the initial phase of the disease). This will increase the knowledge of the     disease and provide new indicators for the selection and evaluation of patients eligible for     new therapeutic approaches.   "
149666|NCT01325012|"     To determine the relationship between perineural catheter location along the sciatic nerve     (popliteal versus subgluteal placement) and infusion effects for ultrasound-guided continuous     sciatic nerve blocks.   "
149667|NCT01324999|"     This study is designed to assess safety and efficacy of tadalafil in patients with     Sarcoidosis Associated Pulmonary Hypertension.      Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients     with Sarcoidosis   "
149668|NCT01324986|"     Available data regarding the effectiveness of laparoscopic antireflux surgery on     extraesophageal symptoms of gastroesophageal reflux disease (GERD) are scarce and mostly     controversial. The aim of the present study was to evaluate the clinical effect of partial     and total fundoplication on extraesophageal symptoms in a selected cohort of patients with     GERD.   "
149693|NCT01324661|"     This study examines youth's motivation for food or social rewards after a brief episode of     simulated ostracism. The investigators hypothesize that youth who think about a friend after     being ostracized will mediate their decision to resort to food, which is typically evidenced     in socially isolated overweight youth.   "
149784|NCT01323465|"     Study to assess the effect of rifampicin, ketoconazole and omeprazole on the pharmacokinetics     of a single dose of Sativex and to evaluate the safety of Sativex when given in combination     with these other drugs.   "
149669|NCT01324973|"     Obesity and physical inactivity have become serious problems for individuals with mental     illness, resulting in increased rates of chronic disease, premature death, and substantial     health care costs. Although in-person psychoeducational interventions help individuals with     mental illness manage their weight, these interventions are often not used because they     require frequent travel to treatment programs and substantial time from clinicians. This     project addresses these barriers by developing and evaluating the effectiveness of an     web-based computer system that is focused on diet and exercise education, and designed to     help individuals with mental illness manage their weight.   "
149670|NCT01324960|"     A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and     tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS) who     achieved a hematological response after 6 cycles of azacitidine. After approval by an     independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an     open label randomized phase II study designed to characterize the efficacy, safety, and     tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher     risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of     azacitidine.   "
149671|NCT01324947|"     The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy     in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in     study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone     due to disease progression.   "
149672|NCT01324934|"     The main objective of the study is the assessment of the overall graft rejection rate (acute,     chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to     standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a     treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year     after renal transplantation.   "
149673|NCT01324921|"     To compare the postprandial glycemic and insulinemic response of subjects with type 2     diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance     test (MTT).   "
149674|NCT01324908|"     This clinical trial studies biomarkers in predicting response in patients with     graft-versus-host disease (GVHD) undergoing extracorporeal photopheresis (ECP). ECP treats     the patient's blood with ultraviolet light outside the body and kills the white blood cells     before returning blood back into the patient's body. Studying samples of blood from patients     with GVHD may help doctors identify and learn more about biomarkers related to GVHD.   "
149676|NCT01324882|"     This research study is about determining how well a Technically Improved Colonoscope from     Olympus works in helping the doctor in guiding the scope through the large bowel or colon.     When a doctor performs a colonoscopy he guides or inserts the scope from the rectum to the     appendix where the small bowel ends and the large bowel begins. There are points during this     insertion where there are turns in the colon which can create a loop in the colonoscope.     These loops can stretch the colon and create some discomfort and also require special     maneuvers by the nurse or patient to help reduce or minimize the loop. Thus, reducing the     looping will make it more comfortable for the patient and more efficient for screening for     polyps. The purpose of the study is to examine this colonoscope and compare it to the     traditional adult colonoscope (Olympus CF-H180). The investigators hypothesis is that this     colonoscope will function better with regard to insertion of the scope from the rectum to the     cecum.   "
149677|NCT01324869|"     This study is designed to access the safety and efficacy of multiple injections of KH902 in     patients with Diabetic Macular Edema (DME).   "
149678|NCT01324856|"     Pancreaticoduodenectomy is the standards surgical procedure for various malignant and benign     disease of the pancreas and periampullariy region. During the recent years, mortality rate of     pancreaticoduodenectomy has decreased to 5% in specialized centers. Although, this procedure     still carries considerable morbidity up to 40%, depending of definition of complications.     Pancreatic fistula remains a common complication and the main cause of other morbidities and     mortality. Pancreaticojejunal (PJ) anastomosis is the most often used method of     reconstruction after pancreaticoduodenectomy. Several technique modifications such as     placement of the stents, reinforcement of anasomosis with fibrin glue, pancreatic duct     occlusion and pancreaticogastrostomy (PG) type of anastomosis was used in order to decrease     pancreatic fistula rate. Since, some retrospective studies showed better results with some     technique, several meta-analyses did not show any advantage of those various modifications.     It was shown that the higher risk of pancreatic fistula was noticed in patients with soft     residual pancreas and small diameter of pancreatic duct. There is only one randomized study     in the literature dealing with this problem. This study did not reveal any significant     differences between PG and PJ in patients with soft pancreas and small duct. In order to     investigate once more this important issue, the researchers conducted randomized multicenter     controlled trial.   "
149711|NCT01324427|"     Telemedicine is a new area of health care where medical information is transferred through     audiovisual media, such as a computer or a video camera, for the purpose of remote doctor's     visits or examinations. This new area of health care is important to test because it can     potentially provide real-time interactions between the patient and their health care team,     including phone conversations, online communication, and/or home visits. Many activities such     as a history review or physical examination can be conducted virtually as compared to the     traditional face-to face visits.      The purpose of this study is to determine patient and health care team acceptance of a     virtual medical visit as a substitute for a face to face visit for patients either     preparing to receive a stem cell transplant or previously received a stem cell transplant.   "
149712|NCT01324414|"     The incidence of Non alcoholic fatty liver disease (NAFLD) continues to increase, and     prevalence estimates for NAFLD range from 17-33%, making it is the most common cause of     chronic liver disease in North America. It is associated with increased cardiovascular     morbidity as well as progression to cirrhosis is a subset of patients. There is currently no     approved treatment for NAFLD. A key barrier to the development of effective therapies is a     lack of consensus on the criteria for diagnosis and endpoints for studies evaluating     diagnostic markers, prognosis and therapeutic modalities.      NAFLD encompasses an entire pathological spectrum of disease, from relatively benign     accumulation of lipid (steatosis) to progressive non alcoholic steatohepatitis (NASH)     associated with inflammation, fibrosis, and necrosis. It has been estimated that 20-30% of     patients with NAFLD will exhibit biochemical and histological changes characteristic of NASH,     and 15-20% of those patients will progress to have cirrhosis. NASH remains an important     phenotypic state, because this sub-group of patients is deemed at high-risk for developing     progressive disease resulting in cirrhosis, liver failure requiring transplantation, or     death.      Although NAFLD has not to date been included as a component of the metabolic syndrome, there     is increasing evidence that NAFLD frequently accompanies the development of insulin     resistance and therefore may be an indicator or predictor of future cardiometabolic risk.     Moreover, recent findings in skeletal muscle of experimental insulin resistance (lipid     infusion) as well as naturally occurring obese and type 2 diabetic, insulin resistant     patients show that skeletal muscle inflammation leads to a pattern of extracellular matrix,     structural, and remodeling abnormalities that closely resemble the TGFb, connective tissue     growth factor (CTGF) mediated fibrotic response that differentiates simple steatotic liver     from NASH. This suggests there may be a common underlying mechanism. Given the ready     availability of skeletal muscle tissue using percutaneous needle muscle biopsies, compared to     the more invasive liver biopsy, it may be possible to use characteristics of skeletal muscle     to distinguish the severity of liver fibrosis.      Given the preponderance of patients being identified with NAFLD, the recognition of less and     non invasive tests that help to discriminate the different phenotypic types of NAFLD would be     highly practical and useful. This would help identify patients at risk of progression to     cirrhosis, and thus make them the target of any available therapeutic interventions.      The investigators hypothesize that 1. Insulin resistance measured through glucose tolerance     test directly correlates with the extent of liver and muscle fibrosis, and 2. Inflammation     and fibrosis in the skeletal muscles correlates with the histopathological changes seen in     patients with NAFLD, and potentially skeletal muscle inflammation may be used as a diagnostic     predictor to differentiate patients with NASH from patients with simple steatosis.      The overall goal of this project is to determine the extent to which inflammation and     fibrosis in skeletal muscle mirrors and is predictive of the level of liver inflammation and     can distinguish NASH from simple steatosis. Specifically, the investigators propose the     following Aims:        1. To use estimates of insulin sensitivity from modeling of oral glucose tolerance tests to          test the hypothesis that the extent of liver and muscle fibrosis is directly related to          insulin resistance.        2. To use liver and muscle biopsies to characterize the changes in abundance of mRNAs and          proteins that characterize inflammation, extracellular matrix remodeling, and fibrosis.          The investigators will use quantitative rt-PCR and immunoblot analysis to compare mRNA          expression and protein abundance of collagens I and III, fibronectin, and connective          tissue growth factor (CTGF) to test the hypothesis that there is a direct relationship          between the levels of these proteins in muscle and liver and the degree of fibrosis.        3. To establish a biospecimen repository of serum, mRNA from circulating white blood cells,          liver and muscle tissue, and DNA to serve as the substrate for future studies of the          pathogenesis of NASH.   "
149785|NCT01323452|"     The primary aim of this study is to asses the efficacy (both virological and clinical) and     safety of ETV in both NA-naïve and NA-experienced chronic hepatitis B patients, and to     explore baseline factors associated with virologic reponse (VR) to ETV.   "
149679|NCT01324843|"     Background:      - Researchers are investigating the use of DNA vaccines to treat various types of cancer by     provoking an immune system response to tumor cells. DNA vaccines mimic the effect of normal     vaccines given to prevent infectious diseases, but they have been less effective than     anticipated in humans. To improve the effectiveness of DNA vaccines, researchers are studying     alternate delivery methods, such as the investigational Derma Vax(Trademark) injection system     that delivers the vaccine into the skin. However, because the Derma Vax(Trademark) system has     not been studied in humans, more research is needed to determine whether this new vaccine     delivery method is safe and tolerable, particularly in terms of pain levels and skin     reactions.      Objectives:      - To evaluate the safety, effectiveness, and relative pain levels of intradermal     electroporation using Derma Vax(Trademark) administered after pretreatment with either a     topical cream anesthetic or placebo cream.      Eligibility:      - Healthy individuals between 18 and 55 years of age.      Design:        -  Participants will be screened with a medical history, physical examination, blood and          urine tests, and an electrocardiogram.        -  Participants will have two different creams applied to their upper arms: one cream will          be an anesthetic (lidocaine and prilocaine) and the other will be a placebo lotion. Each          arm will receive a different cream.        -  Once the cream has taken effect, participants will receive Derma Vax(Trademark)          treatment. No actual medication will be given during the injection; participants will          evaluate their reaction based on the pressure and needle stick alone.        -  Immediately after the treatment, participants will use the Visual Analogue Scale of pain          intensity to provide a description of the level of pain experienced during the          injection.        -  Participants will complete additional questionnaires about pain intensity and will have          the injected skin site inspected to determine possible reactions to the injection. They          will also be asked their opinions on whether (based on pain levels) a series of Derma          Vax(Trademark) treatments would be acceptable for treatment of a serious illness.        -  The day after the injection, participants will return for an additional skin assessment          of the treated areas.   "
149680|NCT01324830|"     The aim of the Phase Ia (dose escalation) part of this trial is to assess the MTD of BI     847325 administered at escalating doses in 2 treatment arms. In the Phase Ib expansion part     of the trial, the aim is to further evaluate the safety profile of BI 847325 at the     recommended dose and schedule and to assess target modulation and the potential antitumour     efficacy in patients with selected tumour types.   "
149681|NCT01324817|"     The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and     the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without     wires and without touching the body.   "
149689|NCT01324713|"     Bone mineral density (BMD) measurement using dual-energy x-ray absorptiometry (DXA) is the     current gold standard for osteoporosis diagnosis and therapy monitoring. Like all     quantitative tests, there is some variability in BMD results obtained when scanning a person     more than once. As such, it is current clinical practice, based on the recommendation of the     International Society for Clinical Densitometry, that each technologist perform a precision     assessment. This approach consists of scanning 30 people twice; the data from which allow     determination of what constitutes a real difference in BMD with 95% confidence. A precision     assessment typically evaluates a specific clinic's population, using the age range and     genders seen at that clinic. However men generally have larger, but often more arthritic,     bones than women which may impact the precision results. Therefore, it is possible that     gender-specific precision values should be used in clinical practice, however this issue has     never been investigated.   "
149702|NCT01324544|"     The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy     of intravenous (IV) buprenorphine in pediatric patients.   "
149682|NCT01324804|"     The negative effect of internal mammary harvesting on sternal perfusion is well known,     especially in diabetic subjects. Microdialysis previously showed increased lactate tissue     concentration after mammary artery preparation. Although high antibiotic concentration is of     utmost importance in this region, no study previously measured the effect of internal mammary     artery harvesting on target tissue antibiotic concentration.      Study hypothesis:      Internal mammary artery harvesting imposes an additional risk for deep sternal wound     infection by impairing antibiotic tissue penetration. This effect is mediated by altered     perfusion patterns and may be seen in cephalosporin and/or Teicoplanin treatment.      Study objective:      To evaluate the impact of left internal mammary artery preparation on target tissue     antibiotic concentration of Cefazolin and Teicoplanin during cardiac surgery      Design:      This study is designed as an observational pharmacokinetic trial. Patients are their own     controls by measuring antibiotic concentration in different subcutaneous tissues.      Study population:      Patients referred for coronary artery bypass grafting to the Department of Cardiothoracic     Surgery with planned unilateral left internal mammary artery preparation and a high risk     profile for deep sternal wound infections will be asked to participate in this trial.   "
149683|NCT01324791|"     Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe     and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of     GERD. This prospective randomized study compares objective and subjective outcome parameters     of Plicator with that of LARS.   "
149684|NCT01324778|"     To compare marginal bone level alterations, implant stability and implant survival between     OsseoSpeed och OsseoSpeed TX   "
149685|NCT01324765|"     The goal of the study is to evaluate the efficacy of a two therapeutic models designed to     enhance women's skills for managing reactive emotions in their current lives as well as to     educate them about how using these skills can enhance their personal effectiveness and help     them to gain control of post-traumatic stress reactions. The interventions adaptations of a     manualized psychotherapy that has shown promise with adults with complex Posttraumatic Stress     Disorder (PTSD) (Trauma Affect Regulation: Guide for Education and Therapy; TARGET) compared     to a supportive group therapy (SGT) that has been found to have modest benefits with women     survivors of childhood abuse (Wallis, 2002).   "
149686|NCT01324752|"     The purpose of this study is to determine if Losartan potassium is affected by PA21.   "
149687|NCT01324739|"     Rationale: B type natriuretic peptide (BNP) is a hormone released from cardiomyocytes in     response to myocyte stretching and serves as a reliable biomarker in the diagnosis of cardiac     dysfunction and heart failure. Recent observations speak for a distinct connection between     chronic heart failure and diabetes mellitus.      Objective: The study was set out to investigate the role of BNP on parameters of glucose     metabolism in a placebo controlled cross-over study in healthy volunteers.      Methods and Results: Ten participants (25±1 years; BMI 23±1 kg/m2; fasting glucose 83±2     mg/dL) received either placebo or 3 pmol/kg/min BNP 32 intravenously for 4h. One hour after     beginning the BNP/placebo infusion, a 3h intravenous glucose tolerance test (0.33 g/kg     glucose + 0.03 U/kg insulin at 20 min) was performed and plasma glucose, insulin and C     peptide were frequently measured. BNP increased the initial glucose distribution volume (13±1     %BW vs. 11±1, P<0.002), leading to an overall reduction of glucose concentration (P<0.001)     especially during the initial 20 min of the test (P=0.001), accompanied by a reduction of the     initial C peptide levels (4.3±0.4 ng/mL vs. 4.9±0.3, P=0.015). BNP had no impact on beta cell     function, insulin clearance or insulin sensitivity.      Discussion: Intravenous administration of BNP increases glucose initial distribution volume     and lowers plasma glucose concentrations after a glucose load without affecting beta cell     function or insulin sensitivity what speaks for the concept that BNP is not diabetogenic, but     improves the metabolic status in patients with heart failure. This opens new questions     regarding BNP induced differences in glucose availability and signalling in several     organs/tissues.   "
149713|NCT01324401|"     Peanut allergy is one of the most serious food allergies because of its life long     persistence, and the potential for severe allergic reactions. Effective oral immunotherapy     would benefit patients by reducing the likelihood that they will have life-threatening     accidental allergic reactions. This research study is being done to develop an effective oral     immunotherapy treatment for patients with peanut allergy.   "
149786|NCT01323439|"     This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the     Axium MicroFX coil system in 100 aneurysms.   "
149688|NCT01324726|"     There has been a great increase in the incidence of infections caused by bacteria that are     resistant to antibiotic agents. Many of these infections result in worse outcomes of patients     and increased costs to the healthcare system. The study aims to survey two germs that are     resistant to a wide range of antibiotics used today. The investigators are particularly     interested in studying the potential to stop the spread and prevent outbreaks of these germs     through contact isolation of patients affected by these germs. Patients will be included in     the study if they have an antibiotic resistant infection caused by any of the 2 bacteria: E.     coli and K. pneumoniae. The research team will then perform rectal, skin (armpit, groin,     umbilicus), throat, urine, and, if applicable, wound cultures to determine other sites where     the germ may be present but not causing an infection. The study coordinator will furthermore     examine the patient's medical record and conduct a short interview in order to evaluate     specific information about the bacteria that have been recovered. This research does not     involve any interventions beyond collection of specimens and there are no added risks to the     patients from the conduction of the study. Neither will there be a benefit at the patient     level. The benefit will be at the level of the patient population, i.e. at a larger scale     once the information collected is analyzed. Only the principal investigator and study     coordinators will have access to all patient-specific information. Once all information is     collected, all patient identifiers, such as name and medical record number, will be deleted.   "
149696|NCT01324622|"     The objective of this study is to compare the clinical and radiographic outcomes of     multi-level laminectomy to multi-level laminoplasty in the treatment of patients with     cervical myelopathy or myeloradiculopathy. The hypothesis for the study is that the     laminoplasty group is not inferior to the laminectomy group.   "
149690|NCT01324700|"     Asthma is common with an increasing prevalence and mortality especially in low-income and     minority populations. The course of asthma appears to be influenced by mood and emotions. It     has been reported that there is a high prevalence of depression or depressive symptoms in     both children and adults with asthma. Despite data on the frequency of depression in asthma     and its adverse consequences, it is generally not recognized or treated. Brown et al.     conducted a randomized, double-blind, placebo-controlled trial of citalopram in 90     outpatients with asthma and MDD. Citalopram therapy was associated with lower depression     scores, numerically greater rates of remission of depressive symptoms, and less oral     corticosteroid use than placebo. The investigators proposed study is different. The     investigators observed a modest difference between antidepressant and placebo in the prior     trial. However, in a subgroup with more severe asthma (based on frequent corticosteroid use)     and more severe depression (based on higher depressive symptoms scores) the investigators saw     a much larger effect size. Standard of care for severe asthma is aggressive asthma treatment.     The investigators study does not require any changes in the patient's asthma treatment. No     guidelines are currently available on the treatment of depression in asthma patients.     Standard care for depression would be antidepressants.   "
149691|NCT01324687|"     The system of medical care for older adults with acute illnesses often serves them poorly.     Many factors limit these patients' access to safe, patient-centered, efficient, high-quality,     acute care. These factors include a shortage of geriatricians and primary care physicians;     limited availability of timely, acute-illness, patient appointments; emergency department     (ED) crowding; interruptions to the continuity of care when patients use the ED; and poor     transitions of care from the ambulatory setting to the ED. These conditions foster     unnecessary ED use, adverse events in the ED for which older adults are particularly at-risk,     and unnecessary medical costs. As the population ages, the magnitude of these problems will     only increase.      The overarching study goals are to develop and evaluate a telemedicine-enhanced care model     that improves access to safe, high-quality, acute illness care for older adults; fosters     appropriate use of health services; and reduces unnecessary expenditures. Specifically, this     study aims to:        1. Expand the existing pediatric HeA telemedicine network to older adults by providing          senior living communities (SLC) with an alternative on-site care option for individuals          with an acute illness episode.           Hypothesis 1: 90% of requested telemedicine visits will be successfully completed.        2. Evaluate the impact of the HeA telemedicine model on utilization, quality of care, and          patient safety.           Hypothesis 2: The rate of ED use will be lower at SLCs with access to care via          telemedicine, as compared to SLCs without such access to care.           Hypothesis 3: Quality of care and patient safety measures will be better for SLC          residents with access to telemedicine-enhanced care than for residents without this form          of access.        3. Evaluate the economic benefit of the care delivered through the telemedicine network.           Hypothesis 4: The net cost of healthcare per patient-month will be less for SLC          residents with access to telemedicine-enhanced care than for those without this form of          access.        4. Use qualitative methods to identify strategies and assets that promote and conditions          that impede the implementation, acceptance, and success of the HeA telemedicine network          in SLCs. This knowledge will inform efforts to develop a toolkit to be used to          disseminate this technology broadly.   "
149692|NCT01324674|"     The Common Mental Disorders (CMD) refer to health states involving non-psychotic psychiatric     symptoms. Part of this broad diagnostic category, symptoms such as difficulty concentrating,     forgetfulness, insomnia, fatigue, irritability, feelings of worthlessness, somatic     complaints, etc. The CMD has a big social impact, and its prevalence in the general     population is 25% and graduate students in health care reaches 40%. The Bach´s Flower     Remedies are considered a complementary therapy approved and recommended by World Health     Organization and by the Brazilian Ministry of Health and in his theory it has great spiritual     nature. In addition, international scientific research have suggested that the strengthening     of spiritual well-being can help significantly and positively promoting mental health. This     project aims to assess the relationship between treatment with Bach´s Flower Remedies and     Spiritual well-being of people with Common Mental Disorders in undergraduate health students     of a university located in São José dos Campos, state of São Paulo, Brazil. This research     presents a quantitative and qualitative methodology, experimental clinical trial, triple     blind. The treatment will take place with two groups of forty people, the group of treatment     and the placebo´s. The trial will happen in six sessions at intervals of 30 days, totaling     eight months of treatment. Statistical analysis will be used chi-square or Fisher exact test     to study the association between the scale of spiritual well-being and the use of Bach     Flowers for each time point (3 times). To compare the evolution of the results (scales)     during the study will set a model for ordinal data with repeated measurements over time. For     these statistical tests is assumed a significance level of 5% (p < 0.005).   "
149694|NCT01324648|"     Lifetime prevalence rates of Major Depressive Disorder (MDD) in Canada are between 10-12%     with approximately 1.5 million Canadians reporting depression in any given year. Alarmingly,     the burden of ill health associated with MDD is projected to increase worldwide such that by     the year 2020, depression will move from its current position of fourth to become the second     greatest burden of ill health, closely following ischaemic heart disease (Murray & Lopez,     1998). As depressed patients are often in frequent contact with their primary care physicians     for other health problems, effective depression treatment and management currently relies     heavily on the primary care sector. Cognitive behavioural therapy (CBT) is an empirically     supported psychotherapy that is recommended by the Canadian Network for Mood and Anxiety     Treatments Clinical Guidelines as a first-line treatment for depression. However, across     Canada, CBT is not readily accessible by primary care physicians for their patients,     particularly in rural areas.      To help address this nationwide need for CBT, British Columbia (BC) is the first and only     province in Canada to develop and implement a high capacity mental health service, Bounce     Back: Reclaim your Health (BB), for primary care patients with mild to moderate depression.     In BB, the patients' use of Cognitive-Behavioural Therapy (CBT) self-help materials is     supported via trained telephone coaches.      The primary objective of our proposed research is to provide direct evidence of the     effectiveness of the BB program, and, in particular, the telephone coaching component. The     investigators will test: (1) whether the BB program is more effective than general     practitioner (GP) treatment-as-usual (TAU); and (2) whether BB's positive results can be     attributed to the telephone coaching component, as this component is associated with the most     significant costs of the program. A secondary objective is to assess the cost-effectiveness     of such telephone support.   "
149695|NCT01324635|"     This is an open label phase I clinical trial with two arms, representing single and     fractionated radiation therapy (Figure 4.1). Within each arm the radiation dose is     pre-determined and not escalated. Panobinostat will be administered orally 3 times a week for     2 weeks. Panobinostat will be dose-escalated independently in each arm. There is no     intra-patient dose escalation.      Recurrent gliomas (Arm A) will be treated according to the Jefferson protocol for     re-irradiation, 10 fractions each of 3.5Gy delivered over 2 weeks. Panobinostat will be     administered orally three times a week for 2 weeks, starting on day 1 or 2 of radiation     therapy. High-grade meningiomas (Arm A) will be treated with 6 weeks/30 fractions of     fractionated radiation therapy, to a total dose of between 54 Gy and 60 Gy in fractions of     either 1.8Gy or 2Gy. Panobinostat will be administered orally three times a week for 2 weeks,     starting on the day of 1st fraction of radiation.      Large brain metastases (Arm B) will be treated with a single fraction of radiosurgery.     Panobinostat will be administered orally three times a week for 2 weeks, starting on the day     of radiation. The radiosurgery may be delivered by either LINAC, gamma-knife, cyber-knife or     tomotherapy technology.   "
149703|NCT01324531|"     The purpose of this prospective, randomized, controlled trial is to compare subjective     patient-reported outcomes and objective clinical results between arthroscopic Bankart repair     with and without arthroscopic infraspinatus remplissage in patients with anterior shoulder     instability with a Hill-Sachs Defect.   "
149704|NCT01324518|"     The purpose of this study is to determine whether ORM-12741 is safe and effective in the     treatment of Alzheimer's disease.   "
149705|NCT01324505|"     This clinical trial is conducted in Europe. The purpose of the trial is to investigate the     influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the     body) of an oral contraceptive combination drug after multiple administration of semaglutide     in female subjects with type 2 diabetes.   "
149706|NCT01324492|"     The present study is designed to collect safety/tolerability data and explore the efficacy of     RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.   "
149707|NCT01324479|"     This study will assess the safety and efficacy of INC280 in patients with solid tumors that     are refractory to current treatment or for which there is not a current standard of care and     whose tumors have dysregulation of the c-MET pathway.   "
149708|NCT01324466|"     The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects     with recurrent herpes labialis (RHL).   "
149709|NCT01324453|"     This study will evaluate change in heart muscle function from baseline to three months and     twelve months in participants who present with a heart attack and a completely occluded     coronary artery. These subjects will be randomized to receive standard Percutaneous     transluminal coronary angioplasty (PTCA)/Stenting to open the artery or routine PTCA/Stenting     plus post conditioning. Post conditioning commences immediately upon reperfusion using four     cycles of thirty second inflations with a standard angioplasty balloon followed by a thirty     seconds of reperfusion. The investigators hypothesize that Postconditioning reduces the size     of the heart attack when utilized with successful primary Angioplasty/stent.   "
149710|NCT01324440|"     The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of the     Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant (MAA).   "
149787|NCT01323426|"     This pilot study examines safety and efficacy of a simple procedure for treatment of stress     urinary incontinence. A muscle biopsy is taken from the thigh, minced and injected into the     urethral sphincter.   "
149714|NCT01324388|"     The purpose of this study is twofold:        1. To evaluate the effect of LY2189265 on how the body absorbs a blood pressure lowering          drug (lisinopril) in participants with high blood pressure who are currently taking          lisinopril.        2. To evaluate the effect of LY2189265 on heart rate and blood pressure in healthy          volunteers when taken with a Beta-blocker drug (metoprolol).      In Part 1, participants will receive four weekly injections of LY2189265 with continued use     of normal lisinopril therapy.      Part 2 is a cross-over study design. Participants will receive a single injection of     LY2189265 in one period, and seven daily doses of metoprolol and a single injection of     LY2189265 in another period.   "
149715|NCT01324375|"     In this consecutive, prospective cohort study the investigators evaluate if preoperative pain     response upon heat stimulation is predictive for acute and subacute postoperative pain after     total hip arthroplasty.   "
149716|NCT01324362|"     The purpose of this study was to determine whether asthma control and reduced bronchial     responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids     with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma   "
149717|NCT01324349|"     The objective of this study is to evaluate the safety and effectiveness of Covidien's     Hemostatic Patch to control bleeding during hepatic surgery. The performance of the     Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic     techniques.   "
149718|NCT01324336|"     The purpose of this study is to compare the pharmacokinetics of a routinely used compounded     liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients     who are receiving treatment with 6-MP as part of their clinical treatment for acute     lymphoblastic leukemia (ALL).   "
149719|NCT01324323|"     The purpose of this study is to evaluate the effect and safety of multiple doses of rifampin     on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.   "
149720|NCT01324310|"     The purpose of this study is to evaluate the effect and safety of multiple doses of     ketoconazole on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.   "
149721|NCT01324297|"     The purpose of this study is to gather normative data from healthy adults and to determine a     sensitive and specific cut-off value for responders and non-responders to the Niacin Skin     Flush Test in a sample of first episode psychosis patients.   "
149722|NCT01324284|"     Lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel     preparation can be improved for a good colonoscopic examination without missing lesions and     complications.   "
149723|NCT01324271|"     The objective of the study is to evaluate the safety and efficacy of the Acclarent     Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under     local anesthesia in an office/clinic setting.   "
149724|NCT01324258|"     This is the first clinical experience in Japan with GSK1120212, a novel MEK inhibitor. This     study is designed to identify recommended doses and regimens in Japanese subjects for the     future development of GSK1120212.   "
149725|NCT01324245|"     The kidney plays a crucial role in maintaining salt balance by two opposing physiological     mechanisms: the renal dopaminergic system which enhances salt excretion and the     renin-angiotensin system (RAS) which causes salt retention. Salt-sensitive hypertension     occurs when this balance is altered or abnormal. We hypothesized that this balance is     influenced by salt intake: therefore dietary salt affects the natriuretic response to the     renal dopaminergic agonist Fenoldopam, and the Angiotensin Converting Enzyme inhibitor,     Enalapril.      In this trial we study normal salt balance mechanisms in salt resistant adults with normal     blood pressure.   "
149726|NCT01324232|"     The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses     of AVP-923 capsules in the treatment of central neuropathic pain in patients with multiple     sclerosis.   "
149727|NCT01324219|"     The investigators are interested in reducing problem behaviors of nursing home residents with     dementia that make providing care difficult. The investigators call these behaviors     resistiveness to care. Previous research has found that resistiveness to care occurs more     frequently when staff use certain types of communication. An inservice program will be     provided to all nursing staff in your nursing home to teach staff about communication     practices to reduce resistiveness to care. The research study will see whether changing     communication will reduce resident resistiveness to care. If effective, the communication     training may then be used to improve care in other facilities.      By doing this study, researchers hope to learn if changing communication practices will     reduce resistiveness to care in nursing home residents with dementia.   "
149728|NCT01324206|"     Background:      - Magnetic resonance imaging (MRI) studies provide important information on the structure and     function of various body systems, including the brain, muscles, joints, heart, and blood     vessels. Scientific applications of MRI scans often use techniques that need to be modified     or refined before they are used in clinical studies. To develop and modify these techniques     for the new Philips 3T Achieva whole-body MRI scanner, researchers are interested in     conducting trial MRI scans on healthy individuals and individuals with conditions that     require imaging studies.      Objectives:      - To conduct preliminary trials of the 3T MRI facility to develop and refine MRI scanning     procedures.      Eligibility:      - Individuals at least 18 years of age who are able to have magnetic resonance imaging.      Design:        -  Participants will be screened with a full medical history and physical examination, as          well as blood and urine tests.        -  Participants will have an MRI scan using the 3T scanner. Some scans may require the use          of a contrast agent or radiotracer, which is a small amount of radioactive substance          that will be injected before the start of the scan. Some participants may be asked to          perform tasks of thinking and movement while in the scanner, in order to test the          procedures required for a functional MRI scan.        -  No treatment will be provided as part of this protocol.   "
149769|NCT01323660|"     This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination     and component, two-period, incomplete block design cross-over study using GSK573719/GW642444.     The primary objective is to evaluate lung function and exercise endurance time after 12 weeks     of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and     62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25     mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI).   "
149729|NCT01324193|"     Chronic kidney disease (CKD) patients have very low physical function and high rates of     cardiovascular disease (CVD) mortality. The objective of the proposed research is to evaluate     the effects of dietary supplementation with a pomegranate extract, that contains high amounts     of antioxidants, on physical function and CVD risk. Patients with moderate to severe chronic     kidney disease that are NOT yet on dialysis tend to have significantly reduced risk factors     for cardiovascular disease (and other disorders) compared to dialysis patients. This includes     significantly reduced systemic markers of oxidative stress and inflammation. As a result,     therapies designed to reduce the risk of CKD co-morbidities may differ significantly in     dialysis and pre-dialysis patients. For example, dialysis patients are recommended to     INCREASE their intake of dietary protein, while pre-dialysis patients are recommended to     DECREASE their protein intake, due to differences in the pathophysiology of the two     conditions. The investigators have decided to recruit pre-dialysis patients in addition to     dialysis patients in this study because the investigators believe this will help us determine     if the efficacy of pomegranate differs between patients with different stages of CKD.   "
149730|NCT01324180|"     H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator,     but will not be recruiting locally.      The purpose of the trial is to study the clinical and biological effects of metformin in     combination with standard systemic chemotherapy in a disease (relapsed ALL) that has a dismal     outcome, as well as to do a dose escalation study to find the Maximum Tolerated Dose (MTD) of     metformin in conjunction with ALL therapy. There have also been analysis of patients enrolled     on trials who were diabetics on metformin and their outcome was better than patients on the     same trial that were not on metformin as their antihyperglycemic.   "
149731|NCT01324167|"     The investigators would like to know the association of gene polymorphisms and metabolic     adversities in clozapine-treated patients with schizophrenia in Taiwan.   "
149732|NCT01324141|"     Background:      - Radiation and chemotherapy treatments for anal cancer can cause irritation of the skin that     can lead to redness and tenderness, and in some cases can be so severe that it results in     blistering or peeling of the skin during treatment. These conditions cause discomfort and may     require breaks from radiation treatment. Researchers are interested in determining whether     MTS-01, a drug that protects cells and tissues from the effects of radiation, can be given     before radiation treatment to prevent these side effects and reduce the irritation of the     skin during chemotherapy and radiation for anal cancer.      Objectives:      - To determine the safety and effectiveness of topical MTS-01 given before radiation in the     groin and gluteal cleft of patients receiving combined radiation and chemotherapy for anal     cancer.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with cancer of the anal canal     and are eligible to receive radiation and chemotherapy treatments.      Design:        -  Participants will be screened with a physical examination, medical history, blood tests,          imaging studies and physical examination of the anal canal, and biopsies as needed to          evaluate eligibility for treatment.        -  Participants will be scheduled for radiation and chemotherapy treatments on the          following schedule:        -  Radiation given 5 days per week for 6 weeks, with topical MTS-01 treatment on the skin          in the groin areas and between the buttocks before each treatment        -  Mitomycin C given intravenously on days 1 and 29 of treatment        -  5-Fluorouracil given intravenously over 4 days (first week and fifth week) during          radiation treatment        -  Participants will be monitored throughout the treatment for side effects, with          photographs of the treatment area and frequent blood tests.        -  Following the end of radiation, participants will have followup visits for 1 year with          blood tests and imaging studies to evaluate the response to treatment.   "
149733|NCT01324128|"     This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety     and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis     patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate     levels in these patients.   "
149734|NCT01324115|"     RATIONALE: NG-nitro-L-arginine may stop the growth of tumor cells by disrupting blood flow to     the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of NG-nitro-L-arginine     in treating patients with advanced solid tumors.   "
149749|NCT01323920|"     A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a     complication of transplantation where the donor graft attacks and damages some of your     tissues. After stem cell transplant, all patients receive prophylactic medications against     GVHD.      In this research study, we are studying the safety and effectiveness of a bortezomib based     GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call     transplantation from a matched unrelated donor, mismatched related or unrelated donor.   "
149735|NCT01324102|"     With advances in the detection and treatment of cancer, there are now 14 million cancer     survivors in the U.S., 500,000 of whom are treated in the Veterans Health Administration. The     mental and physical health consequences of cancer and its treatment may affect a Veteran's     functioning and re-integration back into family, work, and daily life. Recent studies suggest     that yoga may be an effective intervention for improving both the physical and mental health     of individuals after cancer, although this has not been studied in Veterans. This study has     three components: (1) Determine factors that increase participation in Yoga by Veterans using     individual interviews and focus group; (2) Create a Yoga protocol for Veterans adapted from     an existing empirically supported treatment, akin to a phase 1 clinical trial for safety and     tolerability; (3) Evaluate the efficacy of Yoga for improving fatigue, insomnia, anxiety, and     depression after treatment for colorectal cancer, akin to a phase 2 trial with randomization.   "
149736|NCT01324089|"     There is some evidence that when resveratrol (a substance which is found in red grapes,     peanuts and chocolate) is combined with Piperine (a substance found in pepper) it is more     effective in fighting cancer. The purpose of this study is to see if resveratrol in     combination with piperine is more effective than taking resveratrol alone. Since     investigators don't know what dose of piperine to use in combination with resveratrol, two     different doses of piperine will be studied.      Twenty-four participants, equal numbers of males and females, will receive a single dose of     resveratrol (2.5 grams) without piperine, resveratrol (2.5 grams) with piperine (5 mg), or     resveratrol (2.5 grams) with piperine (25 mg).   "
149737|NCT01324076|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking     the blood flow to the tumor. Sorafenib tosylate may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.     It is not yet known whether transarterial chemoembolization using doxorubicin-eluting beads     is more effective when given with or without sorafenib tosylate in treating patients with     liver cancer that cannot be removed by surgery.      PURPOSE: This randomized phase III trial is studying giving transarterial chemoembolization     using doxorubicin-eluting beads and sorafenib tosylate to see how well it works compared with     giving transarterial chemoembolization using doxorubicin-eluting beads and a placebo in     treating patients with liver cancer that cannot be removed by surgery.   "
149738|NCT01324063|"     RATIONALE: Patient abstract not available      PURPOSE: Patient abstract not available   "
149739|NCT01324050|"     The overall aim of this study is to develop and test a psychodynamic Internet-delivered     psychological treatment for patients with mild to moderate major depression and compare its     efficacy to an active control group.   "
151602|NCT01299441|"     The purpose of this study is to determine whether the endotracheal cardiac output monitor     (ECOM) is accurate and predictive in liver failure patients with hyperdynamic circulatory     changes.   "
149740|NCT01324037|"     Deep vein thrombosis (DVT) of the arm, officially called upper extremity DVT is a rare     disorder and accounts for up to 1-4% of all cases of deep vein thrombosis. In case of a     thrombosis, there is a blood clot in one of the veins, which should be treated with blood     thinners (anticoagulants). The aim of the present study is to see whether it is safe to use a     combination of tests for the diagnosis of arm thrombosis. In all patients, we will use a     clinical decision rule (clinical judgement) and a laboratory test (D-dimer testing), in most     patients also an ultrasound of the arm will be done. The combination of these tests was found     to be safe and effective in patients with thrombosis of the legs.   "
149741|NCT01324024|"     The purpose of this study is to determine whether a medication called Vyvanse®     (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of     sustained attention, verbal encoding and recall and working memory, in menopausal aged women.     LDX is a medication used to treat attention deficit hyperactivity disorder (ADHD). The     cognitive difficulties that menopausal women report experiencing are typical of adults who     are diagnosed with ADHD. The investigators will assess whether or not LDX is effective in     alleviating those cognitive disruptions when compared to a placebo.   "
149742|NCT01324011|"     NOTE: This study is in the trial-phase of a 5-year study that included a formative research     phase (Phase 1 - IRB study # 07-1765 Family-based Diabetes Self-management Training for     African American Adults). During the first phase, eight focus groups were conducted with 68     participants and a validation study with 215 African American patients with type 2 diabetes.     The data gathered in Phase 1 informs the refinement of the intervention in this phase.      Purpose: The overall goal of this research is to evaluate, in a randomized controlled trial,     a family-based diabetes self-management intervention for overweight/obese African American     adults with type 2 diabetes (the index participants) and a paired overweight family member     (co-participant) who does not have diabetes. The primary outcome is weight change in the     index participant.   "
149743|NCT01323998|"     This retrospective study aims to assess treatment patterns within 1 year of initiating BPH     treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB)     monotherapy, early combination therapy, and delayed combination therapy. The MarketScan     database will be utilized for this study (2000-2008)   "
149744|NCT01323985|"     The purpose of this study is to provide safety information and to define the optimal     induction and short term maintenance regimen for GSK2315698 to deplete circulating SAP in     healthy volunteers prior to assessing in patients   "
149745|NCT01323972|"     The purpose of this study is to show the consistency of different lots of a candidate vaccine     (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.   "
149746|NCT01323959|"     This study will evaluate the persistence of immune response against diphtheria, tetanus,     pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess     the immunogenicity and safety of another booster dose of BoostrixTM Polio.   "
149747|NCT01323946|"     The objective of the study is to evaluate the immunogenicity and safety of prime-boost     vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.   "
149748|NCT01323933|"     Analysis of safety, tolerability, and PK data will provide information that will guide future     development of AB0024.   "
149750|NCT01323907|"     The purpose of the study is to provide use of Omegaven in children with life threatening     Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical     treatments/therapies have been either ineffective or not feasible in the treatment of this     serious condition. This is a compassionate use protocol.   "
149751|NCT01323894|"     The first year purpose:      The best concentration of canonical Wnt3a will be investigated in promoting the     osteoblastogenesis of human mesenchymal stem cells.   "
149752|NCT01323881|"     This pilot sham-controlled study aims to determine the safety and efficacy of repetitive     transcranial magnetic stimulation given as a facilitatory intermittent theta burst     stimulation (iTBS1200, 1200 stimuli/session) paradigm to enhance motor recovery in subacute     stroke patients.   "
149753|NCT01323868|"     The purpose of this study is to determine the rate of endogenous endophthalmitis in patients     admitted to Stanford Hospital with a systemic infection and positive blood cultures, as this     may improve the clinical care of this population of patients.   "
149754|NCT01323855|"     This is a two part study to compare the PK of preladenant administered to participants with     CRI to the PK of preladenant administered to healthy participants. Part 1 will compare the PK     of participants with severe CRI to healthy participants. Part 2 will compare the PK of     participants with moderate CRI and participants with mild CRI to healthy participants. The     primary hypotheses are that the plasma area under the concentration-time curve from time 0 to     infinity after single dosing (AUC0-∞) of preladenant in participants with either severe,     moderate or mild CRI is similar to that of matched healthy participants.   "
149755|NCT01323842|"     Renal colic is a common (1300 visits per year at our institution) and painful condition     caused by stones in the kidney and ureter, and can be mimicked by life threatening conditions     such as a ruptured abdominal aortic aneurysm (AAA). This can create clinical uncertainty.     Emergency department targeted ultrasound (EDTU) is performed by an emergency physician at the     patient's bedside, and has been shown to be accurate, safe, and efficient. We have shown that     EDTU can accurately identify hydronephrosis, which is a predictor of complications of kidney     stones. A normal formal ultrasound (US) predicts an uncomplicated clinical course. We will     assess the accuracy of EDTU for the diagnosis of hydronephrosis, and when normal, whether     patients can be safely discharged.   "
149770|NCT01323647|"     This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18     months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in     the primary study. The study will also assess the immunogenicity and reactogenicity of a     booster dose of IPV in subjects primed with three doses of IPV.   "
149756|NCT01323829|"     This is a prospective, pilot, longitudinal study to evaluate the use of EMG guidance for     Botox A injection for chronic pelvic pain and HTPFD. The objective of this study is to     determine the efficacy of injecting botulinum toxin type A into pelvic floor muscles that are     high tone. Patients who have been diagnosed with high tone pelvic floor muscle dysfunction     and have failed other treatments will be eligible to participate in this study. Study related     procedures will include perineometry readings. Patients will be required to complete 7     questionnaires for this study. These include visual analog scale (scale from 0-10) for pain     (VAS), the O'Leary-Sant urinary symptoms and problem questionnaires (ICSI/ICPI), Pelvic Floor     Distress Inventory 20 (PFDI-20), the Female Sexual Distress Scale (FSDS), Global Response     Assessment Scale and the SF-12 quality of life scale. The use of the EMG guidance is the     experimental part of the study. We will perform EMG Needle testing in order to pin-point the     best location for the patients Botox injections. This is a prospective, pilot, longitudinal     study to evaluate the effect of Botox A injection for chronic pelvic pain and HTPFD.   "
149757|NCT01323816|"     The purpose of this study is to evaluate and compare outcomes of patients that have received     care in medical intensive care units in a tertiary care facility with two different models;     the traditional model including resident, pulmonary fellow and attending physician and a     nontraditional model which has Nurse Practitioners as the direct care deliverer, a pulmonary     fellow, and an attending.   "
149758|NCT01323803|"     This study will establish a registry for participants with eosinophilic esophagitis (EoE) and     create a research resource that will provide further insights into EoE.   "
149759|NCT01323790|"     The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of     opioid-induced constipation in patients with non-cancer-related pain, including those     patients that have inadequate response to laxative therapy (LIR).   "
149760|NCT01323777|"     The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +3.0     D Multifocal Toric IOL Models SND1T3, SND1T4, SND1T5, and SND1T6 when implanted to replace     the natural lens in Japanese cataract patients.   "
149761|NCT01323764|"     The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus     Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function     in patients with adult hydrocephalus (AH) implanted with ventriculoperitoneal (VP) shunts     when shunt obstruction is suspected and a diagnostic procedure such as radionuclide shunt     patency testing (SPS) is required.   "
149762|NCT01323751|"     Phase 1(a & b): To evaluate the side effects and determine the best dose of oral ACY-1215 as     monotherapy, and also in combination with bortezomib and dexamethasone in patients with     relapsed or relapsed/refractory multiple myeloma.      Phase 2a: To determine the objective response rate of oral ACY-1215 in combination with     bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple     myeloma.   "
149776|NCT01323569|"     This crossover study with six treatment sessions is to evaluate the abuse potential of three     doses of Sativex as compared to Marinol and placebo, in subjects with a history of     recreational marijuana use.   "
149777|NCT01323556|"     Investigation of mechanisms of exposure based learning by        1. Investigating the effects of fear augmentation by interoceptive exposure during in vivo          exposure        2. Disentangling the effects of interoceptive exposure exercises in panic disorder   "
149816|NCT01323049|"     The primary objective is to show that positive pressure extubation improves oxygenation     immediately after extubation compared to extubation via aspiration by evaluating and     comparing the onset time of desaturation during spontaneous ventilation during awakening     following general anesthesia.   "
149763|NCT01323738|"     Many people suffering from alcohol dependence have a history of exposure to stressful life     situations, such as childhood physical or emotional misuse. Often, there's a functional     relationship between drinking and emotional problems related to past traumatic experiences,     i.e. drinking to forget. However, alcohol treatment often does not include interventions to     support patients to cope better with past life experiences. On the other hand, most     alcoholics are poorly motivated to participate in long-term rehabilitative treatments after     detoxification. In the proposed study, the investigators will study the effects of a brief     psycho-educational group intervention during detoxification treatment on motivation to change     and the willingness to accept further treatment.      The investigators will use a group comparison design (intervention versus TAS control     group). In month 1, patients take part in Treatment as Usual (TAS), including a unspecific     information group. In month 2, the information group is replaced by the psychoeducational     group (intervention). Ward staff selects patients for the groups, irrespective of     intervention or TAS. Selection criteria are: absence of severe withdrawal and cognitive     impairment. Absence of severe co-morbid psychiatric disorder (e.g. schizophrenia or suicidal     crisis). The group sessions will take place in groups of up to 15 patients and will include 4     structured sessions (45 min each). Main content if the intervention group is to highlight and     discuss the association between stress, Posttraumatic Stress Disorder and drinking. Patients     will also be informed about the different treatment options available in the region.      At entry, patients are asked to fill in the German versions of the University of Rhode Island     Change Assessment (URICA; McConnaughy, Prochaska, & Velicer, 1983; German: Heidenreich, Hoyer     & Fecht; 2001) and the Trauma History Questionnaire (THQ; Green, 1996; German: Maercker,     2002). At discharge, patients are asked to fill in the URICA.      The investigators expect that specific information on the association between stress and     drinking will increase the patients' motivation to participate in further treatment.   "
149764|NCT01323725|"     The purpose of this study is to identify the effectiveness of team-base financial incentives     for increasing long-term smoking cessation among employees at St. Paul's Hospital, Korea.   "
149765|NCT01323712|"     Patients with Chronic Kidney Disease (CKD) are upto 3.5 times more likely to die from     diseases of heart and blood vessels (Cardiovascular Disease-CVD). Vitamin D insufficiency is     very common in CKD and associated with CVD. Animal studies have shown an improvement in heart     size and function with Vitamin D therapy, although evidence in humans is lacking. The     proposed study will test if oral Vitamin D treatment, in deficient CKD patients, will improve     heart enlargement and function. With these proposed changes the investigators expect to     reduce CVD and deaths in patients with CKD.   "
149766|NCT01323699|"     Behavioral Treatments for Anxiety and Depression (BehTA-D) is a research study for anxiety     and depression in individuals with Parkinson's disease (PD). The research clinicians try to     teach skills that may help participants cope with anxiety and depression in the context of     Parkinson's disease. Research clinicians will also discuss ways improve management of     Parkinson's symptoms. Other skills taught include how to relax, change thinking, add in     meaningful pleasant activity.   "
149767|NCT01323686|"     The aim of this study is to investigate if imaging guided optimal left ventricular (LV) lead     placement improves the response rate to cardiac resynchronization therapy (CRT). Consecutive     patients meeting the standard criteria for CRT are included in a prospective, double-blinded,     randomized trial to LV lead positioning either 1) guided by cardiac imaging using     echocardiography, single-photon emission computed tomography, and visualization of cardiac     venous anatomy (cardiac computed tomography (CT), venography) to target an epicardial vein at     the site of latest mechanical activation without scar tissue or 2) using standard LV lead     placement.   "
149768|NCT01323673|"     The purpose of this study is to determine how clobetasol proprionate foam works against a     placebo foam in the treatment of hand dermatitis.   "
149771|NCT01323634|"     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI     100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily     over a 12-week treatment period in subjects with COPD.   "
167910|NCT00037388|"     To establish a link among Chlamydia infection, sickle cell anemia, and stroke risk.   "
149773|NCT01323608|"     The purpose of this pilot study is to determine the effect of various doses of vitamin D     supplementation on vitamin D stores and calcium excretion in the urine in subjects with     Thalassemia Major (TM). Subjects with TM are routinely placed on vitamin D supplements     because they frequently have osteoporosis (a condition in which bone tissue thins and loses     density and strength) and low vitamin D stores. The amount of vitamin D supplementation that     is required to raise vitamin D stores in optimal levels is not known in TM, and will be     determined in this study. Finally, a recent study in TM has linked blood vitamin D levels to     urine calcium excretion, which is a risk factor for kidney stones. Therefore, we want to     determine changes in calcium excretion with various vitamin D doses and with increasing     vitamin D stores. We plan to test 3 doses of vitamin D for 3 months in children and adults     with TM. Changes in vitamin D blood levels and urinary calcium will be determined. The     results of this pilot study will be used in future studies that will examine the effect of     various doses of vitamin D supplementation in the treatment of osteoporosis in TM.   "
149774|NCT01323595|"     While narcotic medication are commonly used for pain control near the time of surgery, there     are significant side effects including constipation, nausea, risk of overdose leading to     decreased breathing, and risk of addiction to narcotics. Our goal is to explore alternatives     to narcotics for perioperative pain for patients undergoing sperm retrieval surgery. We have     designed a prospective randomized clinical trial to evaluate how effective the     anti-inflammatory medicine celecoxib(Celebrex©) is for pain control near the time of surgery.     Celecoxib is known as a COX-2 inhibitor, a drug that belongs to the non-steroidal     anti-inflammatory drug (NSAID) class. It is used to reduce swelling and to treat pain.      Patients will be divided into two groups: the first group receives a celecoxib pill and the     second group receives a sugar pill(placebo). Patients and doctors will be unaware of exactly     which pills are given. The patient will complete questionnaires for pain level. By comparing     the pain levels we can better understand whether celecoxib (Celebrex©) significantly     decreases perioperative pain.   "
149775|NCT01323582|"     Erythromycin is effectively used in the treatment of Gastroparesis (GP) patients. In     susceptible patients however, it has been associated with sudden cardiac death due to     prolongation of QT intervals and subsequent cardiac risks through its interaction some other     drugs. Azithromycin (AZI) is a macrolide antibiotic but does not have the mentioned druf     interactions , has fewer gastrointestinal side effects, and fewer risks of QT prolongation     and cardiac arrhythmias. Consequently, AZI avoids drawbacks of dosing with erythromycin and     may be preferred as a prokinetic agent in patients on other concomitant medications.      We hope to demonstrate the effectiveness of Azithromycin (AZI) as compared to Erythromycin in     the treatment of Gastroparesis (GP), and later, form the framework for larger     randomized-controlled parallel studies to investigate use of AZI for treatment of GP.      Our novel hypothesis is to determine whether AZI can be used to treat GP.   "
149778|NCT01323543|"     The safety and performance of the Elaspine™ Implant System in the treatment of lower back     pain will be evaluated with a prospective and nonrandomized, multicenter post-marketing     clinical study (PMCS). The study will be enrolled within Germany and Switzerland in 3-5     clinical centres, including in average 10 patients per centre. The study is conducted in     accordance with the Standard ISO 14155, where applicable on clinical investigation of medical     devices for human subjects and other legal requirements.   "
149779|NCT01323530|"     This is a Phase 1b/2, multi-center, open-label, dose escalation and dose-and-schedule     confirmation study of eribulin administered in combination with capecitabine.   "
149780|NCT01323517|"     The purpose of this study is to see the effect of adding a systemic study drug, Ipilimumab,     to two standard chemotherapy drugs, Melphalan and Dactinomycin. The study drug Ipilimumab is     an antibody to a normal protein found in the body, CTLA-4. This protein normally allows the     immune system (the body's natural defense system that helps fight infections) uses to quiet     an immune response. The study drug works by blocking this protein and allowing the immune     system to become more active. This study will investigate the effects, of combining ILI     (using two standard drugs to treat melanoma, Melphalan and Dactinomycin), with the study     drug, Ipilimumab on advanced Melanoma cancer.   "
149781|NCT01323504|"     It is estimated that 800,000 people in France suffer from peripheral artery disease (PAD), of     whom 1-2% present the most severe form critical limb ischaemia (CLI). In this situation, the     patient frequently presents painful non-healing ulcers and focal gangrene. Wound care is     generally associated with increasing pain. Pain relief may be challenging in spite of major     analgesics.      Several studies in this country and elsewhere assessed the usefulness of music for chronic or     acute pain relief during care. However, no data are published regarding the interest of music     therapy for pain relief during local care in PAD patients.   "
149782|NCT01323491|"     The actually most accepted method of effective smoking cessation is based on structured     consultation and medical care in combination with supportive medical treatment. A group of     experts developed the concept EINFACH ERFOLGREICH RAUCHFREI (EASY EFFECTIVE SMOKELESS)     for general practitioners providing a structured compendium for negotiation.      Physicians who have implemented this concept will conduct this non-interventional study. The     implementation of the scheme will be investigated under general practice conditions and the     applicability of the concept has to be assessed by the physicians.      In addition further knowledge of smoking cessation in would-be non-smokers which decided to     quit, supported by medical treatment with NICORETTE®-products, will be documented for a large     patient collective under real practice conditions.      To answer all above mentioned questions for a sufficient number of patients a multicenter,     prospective non-interventional study design was used for this trial as only this instrument     detects characteristics of the physicians' treatment without any further input or other     influences.   "
149783|NCT01323478|"     To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of     Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)   "
149788|NCT01323413|"     The purpose of the study is to examine the influence of demographic, clinical and laboratory     characteristics on the presence and size of penumbra in acute ischemic stroke patients and to     determine those of them which related significantly and independently to the presence and     size of Penumbra. The examined factors will include demographic variables such as age,     gender, ethnic background, vascular risk factors and medical history, clinical parameters     such as time from stroke onset until arrival to the hospital, results of neurological     evaluation by NIHSS and imaging findings, laboratory tests such as body temperature, blood     pressure, glucose level, renal functions etc. and imaging findings - the presence and the     size of collateral blood vessels, the state of carotid arteries (by CTA). The possible     correlation between all this parameters and the presence and the size of penumbra as detected     by CTP will be further examined.   "
149789|NCT01323400|"     The purpose of this study is to evaluate the antitumor activity of pazopanib in patients with     metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST)     resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.   "
149790|NCT01323387|"     Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative     disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.      The primary objective of this study to measure fusion success in patients with lumbar     degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is     evaluation of the patient's quality of life, pain and function.   "
149791|NCT01323374|"     A correlation between increased norepinephrine concentration in the central nervous system     (CNS) and a decrease in fibromyalgia pain has been suggested in clinical studies. Therefore,     as a pro-drug of norepinephrine, droxidopa could potentially benefit fibromyalgia patients by     reducing pain as a result of increasing CNS levels of norepinephrine.      As this benefit is presumed to be a central effect, the addition of carbidopa, a peripheral     DOPA decarboxylase (DDC) inhibitor, may favorably impact the drug's treatment profile.     Carbidopa is utilized as a blocker of peripheral DDC, an enzyme required for the conversion     of droxidopa into norepinephrine. Therefore, inhibition of peripheral DDC should result in a     reduction of any side effects resulting from the peripheral production of norepinephrine,     whilst allowing for increased central levels, and hence, increased centrally mediated     benefits.      The purpose of the study is the obtain information regarding the proper dosing, effectiveness     and safety of droxidopa and combination droxidopa/carbidopa treatments in patients with     fibromyalgia.   "
149792|NCT01323361|"     The study aims to show variation in CA-125 and other inflammatory markers assumed to be a     response to trauma and peritoneal inflammation in the perioperative period of laparoscopic     ventral hernia repair   "
149793|NCT01323348|"     The purpose of this study is to assess whether glycemic control (assessed with HbA1c     measurement) in individuals with type 1 or type 2 diabetes can be improved with a     point-of-care measurement of HbA1c in the ophthalmologist's office combined with a     personalized risk assessment for diabetic retinopathy and other complications of diabetes.   "
149813|NCT01323088|"     In this randomized controlled trial, we will examine the effect of a 3-month exercise     training (aerobic exercise versus resistance exercise) without calorie restriction on total     and regional adiposity, ectopic fat in the liver and skeletal muscle, and risk of type 2     diabetes in overweight girls.   "
149794|NCT01323335|"     Background:      - Uric acid is a substance found in the blood that may contribute to certain chronic medical     conditions and disorders, such as diabetes, insulin resistance, and high blood pressure. High     uric acid concentrations have been associated with stroke and heart disease, as well as     chronic heart failure. In particular, researchers are interested in determining the     relationship between uric acid and inflammatory markers, or chemicals in the blood that can     indicate inflammation and other problems with the body.      Objectives:        -  To study the specific effects of changes in uric acid in the body.        -  To determine whether uric acid contributes to inflammation in the body.      Eligibility:      - Healthy individuals between 50 and 75 years of age.      Design:        -  This study will involve four visits: a screening visit, two study visits, and a followup          visit.        -  At the screening visit, participants will have a physical examination, blood and urine          tests, and an electrocardiogram. Participants will be divided into two groups based on          the existing amount of uric acid in their blood.        -  Within 7 days of the screening visit, participants will have a full-day study visit with          a magnetic resonance imaging scan, followed by a high-fat meal and further blood samples          collected over the following 8 hours.        -  At least 2 days after the first study visit, participants will have the second study          visit, which will require a 2-night stay at the National Institutes of Health.          Participants will have a metabolism test, and will receive the following infusions based          on the groups they were assigned to at the screening visit.        -  Group A (low uric acid) will receive either uric acid or a placebo.        -  Group B (moderate to high uric acid) will receive either Rasburicase (a drug that          reduces the amount of uric acid in the blood) or a placebo.        -  After the infusions and related blood tests, participants will have a high-fat meal with          further blood and urine samples.        -  Approximately 2 weeks after the second study visit, participants will have a final          followup visit with additional blood and urine tests to determine whether the levels of          uric acid in the blood have returned to normal.   "
149795|NCT01323322|"     The Healthy Aging in Neighborhoods of Diversity across the Life Span study (HANDLS) is a     multidisciplinary, community-based, prospective longitudinal epidemiologic study examining     the influences of race and socioeconomic status (SES) on the development of age-related     health disparities among socioeconomically diverse African Americans and whites in Baltimore.     This study investigates whether health disparities develop or persist due to differences in     SES, differences in race, or their interaction. This study is unique because it will assess     over a 20-year period physical parameters as well as evaluate genetic, biologic, demographic,     and psychosocial parameters of African American and white participants in higher and lower     SES. It also employs novel research tools, mobile medical research vehicles, in hopes of     improving participation rates and retention among non-traditional research participants. The     domains of the HANDLS study include: nutrition, cognition, biologic biomarkers, body     composition and bone quality, physical function and performance, sociodemographics,     psychosocial, neighborhood environment and cardiovascular disease. Utilizing data from these     study domains will facilitate understand the driving factors behind persistent black-white     health disparities in overall longevity, cardiovascular disease, and cognitive decline.      HANDLS recruited a fixed cohort as an area probability sample of Baltimore City from August     2004 through November 2009 as Wave 1. HANDLS Wave 2 entitled The Association of Personality     and Socioeconomic status with Health Status - An Interim Follow-up Study began in June 2006     under a separate protocol. It was designed as a follow-up telephone interview approximately     18 months after the initial examination (Wave 1) was complete. Wave 2 provided interim     contact with study participants, and important interim information regarding their health.     Now completed, waves 3 and 4 were the first and second follow-up examinations and     participants second and third visit to our mobile Medical Research Vehicles (MRVs). The     current protocol outlines Wave 5, the third follow-up examination and participants fourth     visit to our mobile Medical Research Vehicles (MRVs). Planned as a follow-up after 3-4 years,     Wave 5 consists of health examinations, questionnaires, a telephone dietary-recall interview,     sensory assessments (visual, olfactory), health literacy assessment, skin color analysis,     renal function assessments, environmental assessments and structural MRIs.   "
149807|NCT01323166|"     The purpose of the study is to compare self-reported health related quality of life after two     different operating techniques for low rectal cancer operated by rectal amputation, using a     specific and detailed questionnaire. The population has been operated over a 6 year period in     one university hospital.   "
149808|NCT01323153|"     This double-blind, randomized, placebo-controlled, multi-center study will evaluate the     safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome     (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized     to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time     on study treatment is 20 weeks.   "
149809|NCT01323140|"     Watson's testosterone transdermal system delivers male sex hormone through skin for the     treatment of men with sex hormone insufficiency.   "
149796|NCT01323309|"     The aim of the study is to compare the benefits of three types of individual treatment     programs for cancer patients: Meaning-Centered counseling, Supportive counseling, and     Enhanced Usual Care.      We would like to train therapists in administering these types of counseling, so that they     have expertise to work on the study. The therapists will administer either the     Meaning-Centered counseling or the Supportive counseling, as part of their training.      Many cancer patients use counseling or other resources to help with the emotional burden of     their illnesses. Counseling often helps them cope with cancer by giving them a place to     express their feelings. Meaning-Centered counseling aims to teach cancer patients how to     maintain or even increase a sense of meaning and purpose in their lives, despite cancer.     Supportive counseling is intended to help the patient cope with cancer by giving them a     place to express their feelings and get support. Enhanced Usual Care is intended to offer the     patient referrals and resources that are matched to their individual needs in addition to the     care they are already receiving at MSKCC.   "
149797|NCT01323296|"     The investigators wish to examine whether a novel 'nanoparticle' of iron oxide, administered     intravenously allows an area of heart muscle damage after heart attack to be visualised using     a magnetic resonance scanner.   "
149798|NCT01323283|"     This study hypothesizes that supplementation of omega-3 fatty acids (OM3) can increase     physical activity, inhibit rapid gain in body weight and BMI in both sedentary and normally     active 8 year old children. The purpose is secondarily to explore patterns of associations     between OM3 supplementation, baseline and follow-up levels in all studied parameters. The     study also aims to study if basal levels of OM3 are correlated with physical activity and to     study if there is an association between basal levels of OM3 and the effect of OM3     supplementation on physical activity. To study if there is an effect of OM3 supplementation     on triglyceride and LDL cholesterol levels and to study if there are more pronounced effects     on children with higher levels. To study if OM3 supplementation, compared with placebo reduce     weight increase among children at risk to become overweight. To study if there is an     association between effects of OM3 on physical activity, weight and risk markers in blood. To     study if there are any gender differences.   "
149799|NCT01323270|"     This study is to look at a new vaccine that might prevent meningococcal disease, and to look     at the safety of the new vaccine as well as how it is tolerated when given together with     Repevax. The study will be done in healthy adolescents.   "
149814|NCT01323075|"     The primary objective is to demonstrate a longer period of neurologic recovery from a sensory     block assessed in each test group versus the group without metabolic disease.   "
149815|NCT01323062|"     This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended     phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects     with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).   "
149817|NCT01323036|"     The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the     blood following consumption of krill oil compared with fish oil and placebo.   "
149800|NCT01323257|"     The purpose of this study is to investigate the effect of steady-state concentrations of     erythromycin or DRV/r on the steady-state pharmacokinetics of TMC435, the effect of a     steady-state concentration of TMC435 (150 mg) on the steady-state pharmacokinetics of     erythromycin and the effect of a steady-state concentration of TMC435 (50 mg) on the     steady-state pharmacokinetics of DRV/r. We will also study the short-term safety and     tolerability of TMC435 given alone and given togehter with erythromycin (Panel 1) or DRV/r     (Panel 2). Steady state is a term that means that the drug has been given long enough so that     the plasma concentrations will remain the same with each subsequent dose. TMC435 is being     investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics     (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and     eliminated from the body.   "
149801|NCT01323244|"     The purpose of this study is to investigate the efficacy of a treatment with TMC435 in     combination with peginterferon alfa-2a and ribavirin in patients who did not clear their     hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial     conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed     against hepatitis C virus (HCV) were evaluated for short periods of time.   "
149802|NCT01323231|"     The objective of this study is to build upon preliminary research and conduct a pilot     feasibility randomized controlled trial on a promising culturally-grounded and     gender-specific treatment program, the XY-Zone. The central hypothesis underlying this study     purports that through receiving the XY-Zone treatment, adolescents will decrease their risk     for dropping out of school. This hypothesis is supported by two years of preliminary data     investigating the effectiveness of the XY-Zone.      To test the central hypothesis, the following specific aims will be pursued:        1. Identify school dropout risk and protective factors (protective factors defined as:          adult support and peer support; risk factors defined as: low school attendance,          inability to achieve grade promotion, substance use, delinquency, school          disconnectedness, misbehavior, disconnection from healthy peers) directly changed as a          result of XY-Zone intervention.        2. Determine the extent to which moderating variables (affective strength, duration in the          program, family functioning, interpersonal strength, intrapersonal strength, level          achieved in the program, and resiliency) effect change in outcome variables (risk and          protective factors).        3. Identify participants' beliefs about the impact of the mechanisms of change (respect,          responsibility, relationship, role modeling, and reaching out) on outcome variables          (risk and protective factors ) to enrich understanding of quantitative data.   "
149803|NCT01323218|"     Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a highly prevalent disorder with     multiple comorbidities.      OSAHS is characterized by repetitive episodes of airflow reduction (hypopnoea) or cessation     (apnoea) due to upper airway collapse during sleep. Its major risk factor is obesity.     However, its pathogenesis is complex and multifactorial. Reduced upper airway muscle tonus     and/or unstable neuromuscular output seem to be involved in this collapsus.      A normal vitamin D status is necessary for normal muscle function and neuromuscular output.     As obesity is associated with a high rate of hypovitaminosis D, it appears of interest to     evaluate the effect of vitamin D supplementation on OSAHS patients with vitamin D deficiency.   "
149804|NCT01323205|"     The purpose of this study is to explore the safety, tolerability, and potential clinical     efficacy of JNJ 40411813 in schizophrenic patients.   "
149805|NCT01323192|"     The main purpose of this study is to evaluate the efficacy of JNS001 titrated to daily doses     of 18 to 72 mg in adults with attention-deficit hyperactivity disorder (ADHD) relative to     placebo.   "
149806|NCT01323179|"     Observational study evaluating pain response after total knee arthroplasty (TKA) in patients     taking strong, weak or no opioids preoperatively.   "
149886|NCT01322126|"     The purpose of this study is to determine whether use of the ultrasound to locate the     epidural space and assist with performing neuraxial anesthesia will decrease numbers of the     attempts required for successful placement of epidural catheter.   "
149810|NCT01323127|"     The main objective of this study is to investigate the influence of seat type (straight chair     versus ergonomic chair) on the sagittal alignment of the lumbo-pelvic complex in two     different postures compared to standing for each individual in both a chronic-back-pain and a     non-chronic-back-pain population.   "
149811|NCT01323114|"     Type 2 diabetes mellitus is a chronic disease with severe long-term health consequences. In     patients with type 2 diabetes mellitus who are also morbidly obese, an abundance of clinical     evidence exists showing that significant clinical improvement in their diabetes occurs     following certain types of bariatric, or weight loss, surgical procedures. There is     additional data showing that bariatric surgical procedures that bypass the beginning of the     small intestine, such as the Roux-en Y gastric bypass, can markedly improve type 2 diabetes     even before significant weight loss has occurred. This early effect on type 2 diabetes prior     to weight loss suggests that bypassing the beginning of the small intestine in patients who     are not morbidly obese may also treat type 2 diabetes. There have been small studies outside     the United States that support the concept of treating type 2 diabetes with a surgical     procedure that bypasses the beginning of the small intestine without causing significant     weight loss; however, data is limited in the United States and a call for comparative studies     has been made internationally. The investigators propose to compare, in patients who are not     morbidly obese, conventional medical treatment of type 2 diabetes to surgical treatment of     type 2 diabetes using a bypass procedure that does not cause significant weight loss, the     laparoscopic duodenal exclusion.   "
149812|NCT01323101|"     Doxycycline is known to exhibit immune modulatory activities beyond its antibacterial     effects. In particular, doxycycline is a potent inhibitor of matrix metalloproteinase 9,     which is a protease derived largely from neutrophils. Recent studies demonstrate a     significant correlation between pulmonary disease severity and sputum concentrations of MMP-9     in patients with CF. In addition, sputum MMP-9 levels are associated with airway remodeling     in CF.      The goal of this study is to determine the therapeutic potential of doxycycline in modulating     host airway inflammation in patients with CF. Specifically, the study will characterize the     PK /PD of doxycycline, evaluate the safety of short term therapy, and explore the     concentration effect relationship between doxycycline exposure and sputum biomarker levels.   "
149818|NCT01323023|"     Prescription for Health is a national program of The Robert Wood Johnson Foundation (RWJF) in     collaboration with the Agency for Healthcare Research and Quality (AHRQ). A major goal of     Prescription for Health is to measure the extent to which comprehensive strategies are     effective in changing patient behavior and quality of life relative to four target health     risk behaviors: diet, smoking, alcohol use, and physical activity. The funded projects will     use a common set of survey instruments to help measure outcomes and draw overarching     conclusions across projects. This study will only be analyzing aggregated data and does not     have responsibility for recruitment of patients, randomization (if applicable), or     interventions. Individual project designs may differ.   "
149819|NCT01323010|"     Metered dose inhalers with spacers are devices capable of providing higher rates of lung     deposition of drugs such as beta agonists when compared to conventional nebulizers, but there     is no consensus about the optimal dose when this is the device of choice and there is     evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when     compared to older children. Other factors that may interfere with response to albuterol     treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious     etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen     that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children.     Security of this new dosing regimen will be assessed by monitoring clinical side effects and     serum levels of albuterol, but the investigators will also examine the presence of 12     different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor     genetics in the response to albuterol. The primary outcome measure will be the need for     hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate     and forced expiratory volume in the first second, the need for additional treatments and     length of stay in the emergency room for those not hospitalized.   "
149831|NCT01322854|"     The IMRT-MC2 study is a prospective, two armed, multicenter, randomized phase-III-trial     comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy     with consecutive boost in patients with breast cancer after breast conserving surgery. 502     patients will be recruited and randomized in two arms: patients in arm A will receive IMRT in     28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor-bed by an integrated     boost, while patients in arm B will receive conventional radiotherapy of the breast in 28     fractions to a dose of 50.4 Gy and a consecutive boost in 8 fractions to a total dose of 66.4     Gy. Primary aim of the study is the assessment of the cosmetic outcome and local control     after breast radiotherapy. The study hypothesis is that intensity modulated radiotherapy     (IMRT) is, in spite of the reduced treatment duration, at least equivalent to conventional     therapy.   "
149936|NCT01320514|"     The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in     reducing the incidence of early postoperative bruising and swelling.   "
149820|NCT01322997|"     Stroke is the leading cause of disability in the United States. One of the reasons that it is     so disabling is because of upper extremity hemiparesis (weakness in one arm), which is     commonly seen after stroke.      The objective of this research is to see if a robotic system worn on the weakened arm like a     brace is more useful in improving the strength and coordination of the affected arm, and     those of other stroke survivors, than therapy only. Muscle weakness and lack of coordination     after a stroke have great effects on how severely disabled the arm is and on quality of life     after a stroke.      In this study, patients may be administered a new robotic brace as part of treatment for     their affected arms. If they use this brace, your electromyography (EMG) signals will be used     to control the powered arm brace. EMG signals are the small electrical signals that result     from the actions of the muscles. The system will listen to patients' muscles, using small     sensors that sit on top of the skin. The device will give the arm a power-assist when     patients bend or straighten their elbows. The investigators want to test how easy and     effective this system is to use. The investigators hypothesize that people using the robot     will be more successful in their rehabilitative efforts - and that their movement will     improve more - than people receiving traditional therapy.   "
149821|NCT01322984|"     Children and youth diagnosed with autism spectrum disorder (ASD) have been shown to react     abnormally to social stimuli, especially to human faces. Children and youth with ASD show     less interest in social stimuli, and may even avoid looking at or interact with such stimuli.     It has been proposed that social stimuli elicit reactions like fear and stress in individuals     with ASD, and this explains the lack of interest and avoidance. The present project     investigates this hypothesis.   "
149822|NCT01322971|"     Bacterial vaginosis (BV) is a common vaginal infection characterized by a pathologic shift in     the normal vaginal flora. BV has been associated with a number of poor reproductive outcomes,     including infertility, preterm labor and premature rupture of membranes. If BV does disrupt     normal embryologic development, then the treatment of BV prior to conception may improve     implantation rates and other pregnancy outcomes in the infertile population.      This is a prospective, randomized, double-blind, placebo-controlled trial in which infertile     women undergoing intrauterine insemination or embryo transfer are screened for BV prior to     treatment. Those patients who screen positive for BV will then be randomized into the     treatment arm(metronidazole 500mg by mouth twice daily for 7 days) or the control arm     (placebo by mouth twice daily for 7 days). The primary outcome, positive pregnancy test rate     (i.e. biochemical pregnancy rate), will then be assessed. Secondary outcomes, such as     clinical pregnancy rate, miscarriage rate, and live birth rate will also be examined.   "
149823|NCT01322958|"     Observational study of the use of ultrasound by emergency physicians in the evaluation of     patients at risk of ectopic pregnancy.   "
149824|NCT01322945|"     The purpose of this study is to evaluate patient nasal outcome following endo-nasal surgery.     This type of surgery is conducted for pituitary and skull base tumors. There is no published     data on trauma to the nose during surgery and how it impacts nasal functioning. The     investigators propose to develop a survey and administer it to patients before and after     surgery to learn about their perception of nasal functioning.   "
149825|NCT01322932|"     The purpose of this study is to assess adherence, tolerability and satisfaction of each     eligible HIV subjects switching from a two- or three-pill tenofovir-emtricitabine-efavirenz     (TDF-FTC-EFV) to a one-pill TDF-FTC-EFV treatment.   "
149826|NCT01322919|"     By using a new software two consecutive laser treatments have been combined to correct the     distance vision and to provide a near vision component in addition to the first treatment.      This study will help us to answer 2 questions:        1. How accurately this combined technique corrects distance and near vision        2. Whether the correction is adequate to remove the complete need for supplementary near          spectacles   "
149827|NCT01322906|"     Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure     Caused by hepatitis B virus (HBV)   "
149828|NCT01322893|"     Women with metastatic breast cancer, receiving first line treatment of any kind     (chemotherapy, endocrine treatment or treatment with antibodies) will be included in this     trial. In connection to treatment, blood samples for determination and enumeration of     circulating tumour cells will be collected at different time points. Serum and plasma will be     collected and stored for future analysis of RNA and DNA.   "
149829|NCT01322880|"     Over the last twenty years micro-finance based interventions have proven to be a popular and     often effective means of improving the economic outcomes of impoverished women. However, the     gains to microfinance based interventions on women's decision making in both economic and     non-economic arenas remains largely unknown. Specifically, the question of to what extent     does access to small-scale credit alone, rather than other programs often combined with     microfinance, affect women's empowerment is of particular interest when determining     interventions in a variety of setting in developing nations. There exists evidence that     women's empowerment is associated with reduced violence and as such maybe an important tool     for improving adult women's wellbeing. In addition increased decision making power by women     has been associated with improvement in children's health outcomes, especially for girls, and     as such may be way generating intergenerational improvements in women's outcomes.      The goal of this project is to disentangle the effects of access to credit alone from the     information on financial and personal decision making that is frequently coupled with these     programs. To accomplish this, the investigators use a randomized field experiment among     participants in Village Savings and Loans Associations (VSLA's). VSLA participants are a     self-selected group of people who pool their money into a fund from which members can borrow.     The money is paid back with interest, causing the fund to grow. The regular savings     contributions to the VSLA are deposited with an end date (usually less than 1 year) after     which all or part of the total funds are distributed to the individual members. The small     loans are paid back with interest which is determined by the group at the time of formation     and the returns from these interest payments are also distributed to the groups. The     investigators then test whether there are additional gains to women's well-being by providing     VSLA participants with training on process-based decision making to determine if there is a     need for additional efforts to improve the decision making structure in households. To the     extent that increased access to credit and more broadly financial resources is limited by     existing constraints on women's decision making power, this additional training may be a     necessary part of the creation of credit markets in improving the health and well-being of     women and children.   "
149830|NCT01322867|"     A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine     Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral     Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form,     Under Fasted Conditions in Healthy Volunteers.   "
149832|NCT01322841|"     The CHICA system is a clinical decision support system that uses adaptive turnaround     documents to provide point-of-care information to clinicians. The investigators will be     studying whether it can help in the diagnosis and treatment of tuberculosis and iron     deficiency anemia.   "
149937|NCT01320501|"     An open-label, prospective, single-arm, multi-center phase IV clinical trial of TarcevaTM as     single agent   "
149833|NCT01322828|"     The purpose of this study to to determine whether a single incision technique or a double     incision technique is more effective in the surgical treatment of distal bicep tendon     ruptures. Patients will be randomized to one of the two techniques upon consenting to the     study. Prior to surgery patients will have their elbow flexion, extension, pronation, and     supination strength measured. Elbow Range of motion will also be measured in each of these     four movements. A number of subjective questionnaires will also be administered to the     patient prior to surgery. The identical objective tests and subjective questionnaires will be     completed by the patient at intervals of three months, six months, one year, and two years     following their surgery. Additional information from patients clinical visits may also be     collected throughout the study.   "
149834|NCT01322815|"     The purpose of this study is to test the safety of GI-4000 and see what effects (good and     bad) it has against cancer over time. This study is also being done to measure the immune     response to GI-4000. Study drug will be given in addition to a standard of care which is a     standard therapy given to patients with your type of cancer (colon).   "
149835|NCT01322802|"     This phase I trial is studying the side effects of vaccine therapy in treating patients with     stage III-IV or recurrent ovarian cancer. Vaccines made from deoxyribonucleic acid (DNA) may     help the body build an effective immune response to kill tumor cells.   "
149836|NCT01322789|"     Type 1 diabetes mellitus results from the autoimmune destruction of the insulin producing     pancreatic β-cells. The autoimmune response begins months or even years before the     presentation of hyperglycemic symptoms. Previous studies with other autoimmune diseases or     acute inflammatory diseases testing the effect of the infusion of mesenchymal stem cells     showed promising results in regulating immune system and promoting some degree of disease     control. The aim of our study is to determine the safety and efficacy of intravenous     infusions of mesenchymal stem cells in newly diagnosed type 1 diabetic patients.   "
149837|NCT01322776|"     This is a multi-center, single arm, open-label, prospective IIS study, which will enroll 40     recurrent MCL patients.The aim is to evaluate the efficacy and safety of bortezomib,     fludarabine and cyclophosphamide treatment and also analyze the relationship between NF-kB     activity and efficacy of bortezomib treatment and whether NF-kB activity can predict MCL     progression.   "
149838|NCT01322763|"     Principal aim: To determine the prevalence of Sleep Apnea- Hypopnea syndrome in obese     children.      Secondary aim: 1. To fix the implication of the adenotonsillar hypertrophy, the obesity and     the hormonal factors in the pathogeny of SAHS in children. 2. To determinate of clinical and     neurophysiologic characteristics of childhood SAHS associated with obesity. DESIGN: A     prospective transversal study.   "
149869|NCT01322347|"     The purpose of this study is to confirm the safety and efficacy of Soluble Ferric     Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in     anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will     be measured primarily by the change from baseline in hemoglobin (Hgb).   "
149870|NCT01322334|"     Upper airway resistance during sleep can present with a range of symptoms from simple snoring     (SS) through to severe obstructive sleep apnea (OSA). Pharyngeal narrowing or collapse leads     to reduction or cessation in airflow during sleep, and is associated with loud snoring.      The investigators hypothesized that regular singing exercises could strengthen pharyngeal     muscles and/or increase their resting tone, and lead to an improvement of symptoms and thus     quality of life in patients with all forms of snoring.   "
149839|NCT01322750|"     With an estimated > 2 million women with undetected breast cancer in the United States, the     need for improved early detection is imperative. Early diagnosis for these women is key to     minimizing quality life-years lost to disease and optimizing success of treatment. Evidence     now exists supporting the finding that systemic spread is an early event in the natural     history of breast cancer, manifested as a release of single cancer cells from the incident,     clinically undetectable tumor, which circulate through the bloodstream and deposit within     remote tissues. Reliable and accurate detection of these circulating tumor cells (CTCs) is     now possible with a simple peripheral venous blood draw. This study hypothesizes that women     with CTCs and no other signs of malignancy have clinically undetectable disease.      This study will attempt to validate this technology as a breast cancer screening test and     acquire data to determine the clinical validity and utility of this proposed screening     methodology on a relatively young, ethnically diverse population who are eligible military     health care beneficiaries. Furthermore, this study will attempt to bank identified CTCs in     order to perform additional molecular analyses in the future. The specific aims are to     develop a simple, reliable, cost-effective, and clinically relevant breast cancer screening     test in order to identify subclinical disease early in its natural history in subjects at     risk of progression to clinically apparent disease over the ensuing decade. The ultimate goal     is to decrease the treatment-related morbidity and cause-specific mortality of breast cancer.     An experienced team devoted to the care of patients with breast disease has been assembled to     achieve this goal.   "
149840|NCT01322737|"     This feasibility trial will evaluate the ability of the SuMO Tissue Access and Resection     System (Apollo Endosurgery, Austin, Texas). The SuMO System utilizes balloons to create a     submucosal pocket and electrosurgical cutting device to resect the mucosa. The SuMO elevates     the tissue from the underlying muscularis using a balloon to distend the submucosa, similar     to what is currently performed with injectable saline in a standard EMR. After dissection of     the lesion, a separate cutting device will be utilized to resect the tissue by cutting around     the border of the targeted tissue. If needed, a standard loop snare will be used to complete     the mucosal resection.   "
149841|NCT01322724|"     The purpose of this study will be to determine if the temperature of water used during     insertion of colonoscopy makes a difference in patient discomfort and sedation requirements.     The hypothesis of this study is patients receiving screening colonoscopy utilizing the water     insertion method with room temperature (cool) water will have similar pain scores and     medication requirements compared to water insertion method using body temperature (warm)     water.   "
149852|NCT01322581|"     Plasmodium falciparum (Pf) malaria remains a major cause of morbidity and mortality     worldwide. A malaria vaccine would contribute towards efforts to control and eliminate     malaria. Optimism that an effective malaria vaccine can be developed is derived in part from     the observation that repeated Pf infections can induce protective immunity; however, the     mechanisms underlying acquired malaria immunity remain unclear. The goal of the current study     is to apply systems biological tools to an observational cohort in an area of intense     seasonal Pf transmission to gain insight into the mechanisms underlying naturally acquired     malaria immunity. This year-long observational-cohort study of 700 individuals (3 months and     25 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf     transmission is intense and seasonal. Asymptomatic Pf infection and malaria episodes will be     detected by passive and active surveillance. Immune parameters of malaria-protected and     -susceptible individuals will be assayed from blood samples collected at strategic time     points relative to the malaria season. The primary objective is to identify genome-wide     expression profiles induced by Pf infection that are associated with protection from malaria.     Secondary objectives include identifying age-related (surrogate for cumulative Pf exposure)     changes in Pf-induced gene-expression and serum cytokine profiles, and examining Pf-specific     antibody profiles that are associated with protection from malaria using a protein microarray     representing 2000 Pf proteins (40 percent of the Pf proteome). Exploratory objectives for     this study are to compare the magnitude and quality of the Pf-specific CD4 plus T cell     response in malaria-protected and -susceptible individuals and determine how this response     varies with age and among individuals before, during, and after malaria season, as well as     compare various immune parameters in Pf-infected and uninfected individuals at the end of the     dry season to investigate host immune factors associated with chronic asymptomatic Pf     infection.   "
149842|NCT01322711|"     Primary and secondary prevention trials with statins, as well as with antiplatelet, clearly     demonstrated that these drugs are able to reduce cardiovascular events. Even if the principal     mechanism of action of statins is to lower cholesterol, other effects, the so-called     pleiotropic effects, have been considered as adjunctive properties potentially accounting for     the anti-atherosclerotic effect of statins.      Inhibition of oxidative stress may be considered an intriguing pleiotropic effect in view of     the fact that oxidative stress is thought to be a key event in the initiation and progression     of atherosclerotic disease. Reduction of several markers of oxidative stress including     isoprostanes, 8-hydroxydeoxyguanosine (8-OHdG), and nitrotyrosine have been observed after     statin treatment. NADPH oxidase is among the most important sources of reactive oxygen     species involved in atherosclerotic disease. The investigators developed an ELISA to evaluate     serum levels of soluble-gp91phox, the catalytic core of phagocyte NADPH oxidase. Recently the     investigators showed that statins (30 days treatment) exert an antioxidant effect via     inhibition of soluble gp91phox expression.      The exact mechanism by which atorvastatin reduces NADPH oxidase, however, is unclear. Recent     study showed that statin treatment inhibits leukocyte ROCK activity, a protein kinase     implicated in the activation of NADPH oxidase, with a mechanism that seems to be independent     from lowering cholesterol. To further study the mechanism(s) implicate in gp91phox     downregulation by statin the investigators planned the present study in patients with high     risk of vascular events such as hypercholesterolemic and Type 2 Diabetes mellitus patients.      In addition the investigators want to evaluate the synergistic role of atorvastatin with     aspirin treatment.   "
149843|NCT01322698|"     Our primary objective is to evaluate the relevance of the early determination of Candida     infection status among non-neutropenic patients hospitalized over 48 hours in ICUs.   "
149844|NCT01322685|"     The purpose of this study is to study the Development and Application of Rapid Nucleic Acid     Diagnostic Kits for Clinical Specimens. Subjects are divided into two groups which are health     group and Tuberculosis or lung cancer group in order to compare with the difference.   "
149871|NCT01322321|"     This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a     mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.   "
149872|NCT01322308|"     The present study aims to investigate the effect of pioglitazone (30 mg/day) on endothelial     function in premenopausal women with SLE (systemic lupus erythematosus). Patients with     hypertension, endocrine, hepatic or renal diseases will not be included, or pregnant /breast     feeding women. This is a randomized, double blind, placebo controlled study.   "
149845|NCT01322672|"     Recent data suggests that anesthetics can have prolonged effects on gene expression, protein     synthesis and processing as well as cellular function in ways that the investigators are only     beginning to understand, especially in the very young and the elderly. Within moments to days     of emerging from anesthesia - cardiac or non-cardiac - some patients experience mild to very     severe disorientation and changes in memory and thinking ability without apparent cause. For     the vast majority of patients, this Post-Operative Cognitive Dysfunction (POCD), generally     subsides, but for some with diminished cognitive reserve - especially the elderly, those     with less education or prior CNS events such as stroke or early dementia - changes in memory     and executive function may persist. If prolonged for more than three months, POCD has been     linked to an increased risk of death. In 1-2% of elderly patients, the problem may ultimately     continue for more than a year, leading to a loss of ability to care for themselves and early     demise. Though this may seem like a small percentage, seniors will comprise up to 40% of the     50-75 million surgical procedures performed annually over the next 20-30 years. This amounts     to 70,000 - 200,000 elder affected, and for them and their families, the cost of POCD in     longer-term care, lost wages, and extended suffering will remain very high.   "
149846|NCT01322659|"     The purpose of this study is to determine whether helmet is effective as device for     noninvasive positive pressure ventilation in the weaning from mechanical ventilation.   "
149847|NCT01322646|"     There is clear, converging evidence from multiple prospective studies with well-diagnosed     adolescents with ADHD and comparison, non-ADHD adolescents, that teen drivers with ADHD have     more accidents and other adverse driving outcomes. Available research indicates parental     monitoring and limit-setting for adolescent drivers is one of the most effective     interventions for preventing negative driving outcomes. For children with ADHD, interventions     to promote parenting capacity to effectively oversee and intervene in teen driving will     likely need to be intensive and require multiple treatment components. The present proposal     aims to compare the standard care for teen drivers (driver's education classes and driving     practice) to the Supporting a Teen's Effective Entry to the Roadway (STEER) program, that     includes a parent-teen intervention, adolescent skill building, parent training on effective     adolescent management strategies, joint parent-teen negotiations sessions, practice on a     driving simulator, parental monitoring of objective driving behaviors, and the targeting of     safe teen driving via contingency management strategies (i.e., parent-teen contracts). To     facilitate teen and parent engagement the intervention will be preceded by a motivational     interview. The specific aims of the proposal are to investigate the efficacy of the STEER     program relative to a standard care group in a randomized clinical trial (N=172) on measures     of objective driving outcome and parenting capacity. It is hypothesized that the STEER     program will result in improved outcomes relative to the standard care group at the end of     intervention and 6 and 12 month follow-up assessments.   "
149848|NCT01322633|"     The primary objective is to assess whether the risk of gastric cancer is increased in     pantoprazole users compared to users of other proton pump inhibitors.   "
149849|NCT01322620|"     This study is conducted in Africa, Asia, Europe, North America and South America.      The purpose of the survey is to identify the key psychosocial issues affecting patients with     haemophilia.   "
149850|NCT01322607|"     Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an     extremely high energy cost of movement and contributing to overall disability and lower     quality of life. Therefore, interventions targeting movement economy should be developed for     those in the chronic phase of stroke recovery. This study is designed to compare the effect     of two distinctly different exercise paradigms (a higher-intensity treadmill training program     and a lower-intensity group exercise program) on economy of movement during over-ground     walking and activities of daily living, as well as the extent to which gains in muscular     strength, muscular endurance, and balance predict changes in movement economy.   "
149851|NCT01322594|"     Phase I study to evaluate the safety and tolerability of single ascending intravenous doses     of MEDI2338 in subjects with stable, mild to moderate chronic obstructive pulmonary disease     (COPD).   "
149858|NCT01322490|"     The purpose of this study is to determine whether PROSTVAC alone or in combination with     GM-CSF is effective in prolonging overall survival in men with few or no symptoms from     metastatic, castrate-resistant prostate cancer.   "
149853|NCT01322568|"     Background:      - Researchers are interested in studying the environmental and genetic factors that play a     role in health and living conditions as people age. Since 2002, the U.S. National Institute     on Aging and the Icelandic Heart Association Research Institute have been conducting a     long-term study known as the Research in Aging project to collect personal data and samples     from Icelandic men and women in order to study risk factors related to disease and disability     in old age. Researchers plan to initiate a second stage of the study.      Objectives:      - To collect additional personal information, medical records, and blood samples from     individuals who have previously provided materials for the Research in Aging Project in     Iceland.      Eligibility:      - Individuals who have previously participated in the Research in Aging project in     association with the U.S. National Institute on Aging and the Icelandic Heart Association     Research Institute.      Design:        -  Participants will have a physical examination with imaging analysis procedures and          hearing and eye tests, provide information on health and diet, and provide a 100-ml          blood sample for testing.        -  Participants will also provide consent for researchers to consult data and samples          collected during the first stage of the Research on Aging project.   "
149873|NCT01322295|"     Elective open aortic aneurysm repair has an overall reported 30 day mortality of 2-6 percent,     but in patients more than 65-70 years the mortality is reported to be more than 10 percent.     The phenomenon of acute lung injury (ALI)/adult respiratory distress syndrome (ARDS) after     infra renal abdominal aneurysm repair caused by ischemia-reperfusion is well established. The     degree of disability varies from a light degree of acute respiratory failure to mortality for     patients with the same profile of risk.      Primary aim is to develop a model that monitors inflammatory marker molecules collected from     the bronchial epithelial lining fluid by microdialysis. The method with examination of the     bronchial epithelial lining fluid by microdialysis and analysis of multiple inflammation     markers as previously done by the investigators group.   "
149874|NCT01322282|"     This study is designed to assess bioequivalence between two products used for treatment of     allergy.   "
149854|NCT01322555|"     Background:      - People with autism and autism spectrum disorders have problems with communication,     behavior, and socializing, and many also have intellectual and developmental disabilities.     The cause of autism is not known, but previous research has suggested an association between     autism and immune changes in the brain. Researchers are interested in using the experimental     radioactive drug (11C)PBR28, which attaches to a protein in the brain that is involved in     immune changes, in positron emission tomography (PET) scanning of people with and without     autism to see if there are greater immune changes in those with autism.      Objectives:      - To determine if positron emission tomography scanning can be used to evaluate changes in an     immune system protein in the brains of people with autism.      Eligibility:      - Individuals between 18 and 45 years of age who have been diagnosed with either autism or     autism spectrum disorders, or are healthy volunteers.      Design:        -  Participants will be screened with a physical examination and psychological examination,          medical history, questionnaires about behavior and mood, and blood and urine tests.        -  Participants will have two imaging studies of the brain at separate study visits. The          first study visit will involve a magnetic resonance imaging (MRI) scan to provide a          baseline image of the brain. The second study visit will involve PET scan with the          radioactive chemical (11C)PBR28 to study immune system proteins in the brain. The MRI          scan will take about 40 minutes, and the PET scan will take about 2 hours.        -  Participants will have a final study visit 24 hours after the PET scan to provide a          final blood sample for testing.   "
149855|NCT01322529|"     Forty percent of pregnant women in the United States are women who have never given birth. As     a group, they sometimes have complications with their pregnancy, but there is no information     from a previous pregnancy to identify who might have a problem. Very little research has been     done with this group. The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be     (nuMoM2b) is collecting data from a diverse population of about 10,000 women who are having     their first baby and are carrying only one baby. The women are enrolled early in pregnancy     and undergo research assessments four times during their pregnancies. Data are collected     through interviews, self-completed data forms, clinical measurements, ultrasound, and     collection and storage of blood samples, urine samples, and fluid from the vagina and cervix.     Some information comes from medical records. A subset of women may be asked to participate in     substudies collecting information on sleep breathing, sleep patterns and quality, or other     areas possibly related to birth outcomes. The goal of the research is to find ways to     identify women in this group who might develop a problem with their pregnancy and use this     information to improve the health of pregnant women and their babies in the future. The study     is focusing on pregnancy problems like high blood pressure, babies that are born much too     early and very small babies.   "
149856|NCT01322516|"     We propose to follow a cohort of pregnant and post-partum Canadian women through the fall and     winter of 2009/2010 and the anticipated second and third waves of the current pandemic in     order to better understand the incidence, complications and risk factors for severe disease     due to H1N1 influenza in pregnant women, and to contribute data on the safety and     effectiveness of antivirals and vaccines in this population.      The primary hypotheses to be tested are:      (i) pandemic influenza infection in the second and third trimester of pregnancy is associated     with an increase in adverse fetal outcomes (fetal loss, stillbirth, neonatal mortality,     significant neonatal morbidity, prematurity) (ii) close contact with young children (<2 yrs)     at home or work is the most important risk factor for influenza in pregnant women (iii)     higher scores on a scale of community infection prevention (a combination of self-reported     hand hygiene adherence, avoidance of ill persons and avoidance of crowds) are protective     against influenza (iv) receipt of seasonal influenza vaccine from 2007 to 2009 will increase     the risk of illness due to influenza A(H1N1)v in the second and third waves of the pandemic.      (v) pandemic influenza vaccine is effective in preventing symptomatic influenza in pregnant     women.      (vi) vaccination of pregnant women against a particular strain of influenza protects their     infants against influenza infection in the first six months of life.   "
149857|NCT01322503|"     Objectives: To evaluate the role of human histo-blood group antigens in susceptibility to     Norovirus infections.      Description of Study Design: Healthy volunteers with different blood types and low antibody     titers to the challenge strain will be challenged orally with a Norovirus in the CCCR     inpatient facility. Subjects with resistant (non-secretors) or susceptible (secretors (of     either A, B or O blood group)) to the challenge strain will be recruited. The challenge study     will be conducted in two groups of twenty, each with approximately ten secretors and ten     non-secretors. Three additional subjects per group will serve as alternates in the event that     any of the study subjects are unavailable or become ineligible at the time of the inpatient     study. Subjects will be monitored daily in the isolation facility for at least five days     following this challenge for daily clinical and virological evaluations. Subjects will return     to the investigational site for evaluation the day after discharge from the inpatient unit     and about 30 days (28-35 days) post challenge.      Study Endpoints: Norovirus infection as assessed by viral shedding, seroconversion and     clinical illness assessed by the duration and severity of symptoms   "
168004|NCT00038636|"     The purpose of this study is to determine the safety and effectiveness of a high dose of     ABT-378/ritonavir   "
149875|NCT01322269|"     The purpose of this study is to evaluate the safety and tolerability of three dose levels of     HQK-1001 administered once daily for 26 weeks in subjects with sickle cell disease.   "
149876|NCT01322256|"     The investigators' primary objective is to assess the predictive power of PET/CT scanning in     the evolution of infectious osteoarthritis of the diabetic diabetic after antibiotic therapy     prescribed by national and international recommendations.   "
149912|NCT01321788|"     Pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism     (VTE). VTE remains the most common cause of maternal death in the developed world. It is up     to 10 times more common in pregnant women than non-pregnant women of comparable age. More     than a third of pregnancy-related VTE occurs during the six weeks after delivery. When     compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy     associated VTE by three-fold.   "
149913|NCT01321775|"     The purpose of this study is to determine the efficacy of the combined therapy Bevacizumab,     trastuzumab and paclitaxel in neo-adjuvant therapy in patients with breast cancer HER 2+     followed by surgery and adjuvant therapy (Cyclophosphamide, Trastuzumab and Doxorubicin     liposomal).   "
149859|NCT01322477|"     HCC (Hepato-cellular Carcinoma) is the fifth most frequent cancer in humans and its     prevalence is growing. The most effective treatment of HCC is surgical and includes resection     and liver transplantation; however, only 20% of the patients can be treated surgically. Local     interventional therapy, such as radiofrequency (RF) ablation and transarterial embolization     is also used.      Recurrence rate is very high, and extrahepatic disease develops in about 30% of the cases and     in up to 20% after liver transplantation.      Systemic treatment is thus an option. Sorafenib (multi-kinase inhibitor) is the first agent     to significantly improve the overall survival in advanced HCC. However, the drug has serious     side effects and is very expensive.      PET/CT with F18-FDG is a common tool for systemic evaluation and staging of various tumors.      The value of the FDG PET for evaluation of HCC is controversial, in particular due to the     unique metabolic pathway of glucose in the HCC cells. Since 2007 more and more studies     suggest the feasibility of FDG PET/CT for monitoring local recurrence (especially after RF)     and metastatic spread of HCC, including detection of active disease only suspected by AFP     (alphafoetoprotein) elevation.      Early detection of treatment response to therapy by whole body FDG PET/CT allows for change     of treatment as early as possible,when the tumor is non-responsive before serious side     effects appear or before depletion of body resources.      The aim of our study is to investigate the contribution of FDG PET/CT to assessment of     treatment response.   "
149860|NCT01322464|"     Study to assess effect of food on the bioavailability of a single dose of Sativex and to     measure its' pharmacokinetics after a single and multiple doses.   "
149861|NCT01322451|"     The purpose of the study is to evaluate the relative bioavailability of two solid oral     formulations of GLPG0259 administered after a meal.   "
149862|NCT01322438|"     The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how     your body absorbs and distributes BAY73-4506.   "
149863|NCT01322425|"     The pathophysiology of pain related to fibromyalgia is not understood. This condition is     difficult to diagnose and to treat. One clue may be that tender points (areas which hurt     typical of fibromyalgia) are most densely located near the clavicles. This is also the area     where brown fat is located in humans. Brown fat is typically used to maintain body     temperature. Stress (such as cool temperature or special diets, i.e., high fat, low     carbohydrate) appears to worsen the pain seen in fibromyalgia. We hypothesize that a     mechanism for pain in this disease relates to activating brown fat through neural mechanisms.     The nerves to brown fat also go into adjacent muscle and skin. So, when brown fat is turned     on or increases in amount, collateral nerves may cause pain at the tender points.      The central hypothesis is that stress such as temperature or diet will activate brown fat.     Patients with fibromyalgia will have greater activation or volume of brown fat. Neuralgia     related to stress may be the etiology of the pain. If this hypothesis is proven, there are     several drugs on the market that could be deployed to correct these patients' problems.     Therefore, this project, if successful, will lead to clinical trials of these drugs in     fibromyalgia patients.   "
149864|NCT01322412|"     Physical exercise has been identified as a major item of many chronic diseases and cancer     rehabilitation.      Therefore, physical activity for health is a valid and relevant way to improve quality of     life and to manage cancer patient fatigue. The aim of the study is the assessment of the     effects of a physical activity retraining program on aerobic capacity, strength and fatigue,     in a breast cancer population treated by adjuvant chemotherapy.   "
149865|NCT01322399|"     The primary purpose of study is the collection of feasibility data for a larger trial of     Structural Integration (SI)(an alternative manual therapy) for chronic low back pain. The     secondary purpose is the collection of preliminary data on 1) the therapeutic effect of SI     plus usual care versus usual care alone - the hypothesis being the the effect size will be     significantly greater in the SI plus usual care arm; and on 2) specific hypothesized     mechanisms of that hypothesized therapeutic effect: a) improvements in cognitive behavioral     factors; b) improvements in standing balance and gait, and c) improvements in selected blood     biomarkers.   "
149866|NCT01322386|"     The goals of the proposed work are two fold:      Firstly, to see if the antibiotic vancomycin may be used for the early treatment of Biliary     Atresia (BA) and Primary Sclerosing Cholangitis (PSC). The investigators hope to learn what     effect Vancomycin has on the bacteria that are present in stool, body fluid or intestinal     tissue on someone who has BA and PSC and if so by what mechanism. Secondly, the investigators     hope to learn to characterize human intestinal microbial communities (microbiome: the     collection or collectivity of microorganisms) using molecular methods, examine the mechanisms     of interaction between host and microbiome using genomic approaches, and determine how the     microbiome both preserves local health and promotes pathology. The investigators will focus     on primary sclerosing cholangitis, biliary atresia, as well as states of health. The     composition of the associated microbiome will be assessed based on ribosomal DNA and RNA     sequences, and attention will be given to richness (diversity), evenness (relative     abundance), and variation with respect to time, person, and anatomic niche. Host response at     the adjacent mucosal surface will be assessed based on genome-wide gene expression patterns.   "
149867|NCT01322373|"     This follow-up study is designed to obtain longitudinal clinical and MEG scan data to gain     information on Alzheimer's disease (AD) progression, the stability of healthy control (HC)     MEG scan data, to enrich the Orasi database of AD and HC subjects, and is intended to extend     the capabilities of the Synchronous Neural Interaction® (SNI) test, which is under     development by the sponsor, Orasi Medical. The current study is intended to extend the     database of AD and HC MEG scans and will include patients who previously enrolled and     completed Orasi Protocol ADG 08-01. This study will include MEG scans on up to approximately     50 AD subjects and 70 HC subjects. Additionally, AD subjects will complete 3 standard     functional tests while HC subjects will complete 2 standard functional tests. ApoE genotyping     also will be determined for all subjects. The results generated in this study will be used to     improve the accuracy of the SNI test for diagnosing and tracking the progression of AD.   "
149868|NCT01322360|"     The purpose of this study is to evaluate the tolerability and safety of oral morphine sulfate     in the treatment of postoperative pain in different pediatric age groups following     multiple-dose administration.      To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects.      To compare plasma concentration of morphine sulfate in each age group of pediatric subjects     with adult plasma morphine sulfate concentrations.   "
149877|NCT01322243|"     In this study, we would like to explore the hypothesis that changes in metabolic state,     induced by altering hormone levels and patterns of neural activity, affect the experience of     anxiety in humans. We will also investigate if there is a link between high anxiety and     higher caloric intake. Our aim is to characterize whether changes in current metabolic state     systematically influence anxiety induced by a well established behavioral task known as the     threat of shock. The neural regions activated by this behavioral task in healthy subjects     have been well characterized. We have a priori regions of interest that include the insula,     anterior cingulate cortex, hypothalamus, amygdala, and prefrontal cortex. As our primary     outcome, we will assess neural activation with whole-brain functional magnetic resonance     imaging to determine whether brain regions are differentially engaged when subjects     experience anxiety across different metabolic states. We will correlate these changes with     psychophysiological measures of anxiety and metabolic state.   "
149878|NCT01322230|"     The purpose of this study is to compare the educational efficacy of instructional design     enhancements in on-line learning modules in the context of clinical medical education.   "
149879|NCT01322217|"     This study will collect information on health status and risk behaviors, as well as basic     demographic and biomedical information for a group of HIV positive adolescents receiving care     at sites newly participating in ATN III.   "
149880|NCT01322204|"     The purpose of this study is to determine the absorption and bioavailability of codeine in     relation to postnatal (PNA) and postconceptional (PCA) age; determine the parent drug     (codeine), its active metabolites, their formation rates and their ratios in relation with     PCA and PNA; and identify relevant genetic polymorphisms of opioid metabolism in the study     population and their potential relationship to the biodisposition and pharmacodynamic effects     of codeine. The study population is intubated and mechanically ventilated infants equal to or     greater than 26 weeks gestational age at birth and less than 4 weeks postnatal age.   "
149881|NCT01322191|"     This study was originally undertaken to evaluate the analgesic efficacy of an intravenously     administered dose of ketorolac compared with intravenous morphine in the relief of acute,     postoperative pain in children admitted to the Intensive Care Unit. Using the urine and     plasma samples originally collected from patients in the morphine treatment group and which     were never analyzed, this proposal seeks to study the pharmacokinetics and metabolism of     intravenous morphine in critically-ill children along with its concentration-related efficacy     using prior measures of pain.   "
149882|NCT01322178|"     The aim of this study is to explore whether cetuximab in combination with mFOLFOX6 as     treatment could improve the resection rate in patients with KRAS wild-type, unresectable     liver metastases of mCRC.   "
149883|NCT01322165|"     The National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular     Conditions (GenTAC) was initiated in 2006 by the National Heart, Lung, and Blood Institute     (NHLBI) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases     (NIAMS). GenTAC established a registry of 3706 patients with genetic conditions that may be     related to thoracic aortic aneurysms and collected medical data and biologic samples. The     study ended in September 2016. Data and samples are available from NHLBI and requests should     be made to BioLINCC. See the NHLBI website for more information:     https://www.nhlbi.nih.gov/research/resources/gentac/.   "
149884|NCT01322152|"     The objectives of this study are to evaluate the efficacy and tolerability of single-week     regimen of irinotecan plus capecitabine in the first-line or second-line treatment of     advanced colorectal cancer.   "
149885|NCT01322139|"     This study was to evaluate effects of Sativex on electrocardiogram (ECG) traces when     administered at its therapeutic dose of 8 sprays per day and at multiples of the therapeutic     dose (24 or 36 sprays per day), and to evaluate its safety and tolerability.   "
149887|NCT01322113|"     This study deals with the possible molecular mechanisms that underlie the etiology of bipolar     disorders (BD). Previous studies have implicated Na+, K+-ATPase and endogenous digitalis-like     compounds (DLC) in the depressive state of this disease. The possibility, however, that they     are also involved in the manic phase of the disease was never addressed. The results of this     study may have significant implications for the treatment of BD by DLC derivatives.   "
149888|NCT01322100|"     Because electrochemotherapy is a quick and effective treatment for cutaneous metastases, a     novel electrode device has been developed for treatment in soft tissue such as the brain. Up     to 18 patients will be treated in this phase I dose-escalating study of electrochemotherapy     for brain metastases. Primary endpoint of the clinical trial is safety and secondary endpoint     is efficacy. One brain metastasis is treated once-only with the electrode device guided     stereotactically through a burr hole using CT monitoring. The patient will be fully     anesthetized during the treatment procedure. Patients are followed up for 6 months with     regard to neurological function, Barthel Index, steroid use and adverse effects registration     (CTCAE). Tumor response will be evaluated by Magnetic Resonance imaging (MRI).   "
149889|NCT01322087|"     Rationale:      The objective of this study was to investigate whether a new energy dense food concept, on     order 24 hours a day, would lead to a minimum 75% intake of nutritional needs in patients at     nutritional risk. The investigators target was for 70% of patients to reach 75% of their     energy and protein requirements.      Methods:      An intervention study was conducted with inclusion of 40 patients at nutritional risk,     according to the NRS-2002 criteria. The food concept consisted of 36 small delicious dishes.     Patients could choose food from both the new concept and the ordinary patient buffet. The     investigators monitored patients' nutritional requirements and daily nutritional intake.   "
149890|NCT01322074|"     In this study we evaluate if there is a correlation between acute pain and systemic     inflammatory markers after total Knee Arthroplasty (TKA).   "
149910|NCT01321814|"     The main purpose of this study is to investigate whether cognitive behaviour therapy (CBT)     can be useful for people suffering from Hyperacusis.      Also, the investigators are interested in investigating this group of patients on psychiatric     and somatic comorbidity, personality traits, and startle response to sounds.      The investigators will also study the audiological measures commonly used in Sweden to     measure hyperacusis, and investigate their validity.      The investigators hypothesize that CBT might be helpful for patients suffering from     Hyperacusis.   "
149891|NCT01322061|"     Opioids are the corner stone in the treatment of post operative pain. Because of the several     side effects of opiods, non-steroidal anti-inflammatory drugs are usually added     postoperatively to decrease the total requirements of opioids. However, non steroidal     anti-inflammatory drugs have side effects of their own. Vitamin C, with virtually no side     effects when used on short-term basis, has been shown to have promising analgesic effects in     chronic pain and acute pain relief following orthopedic surgeries.      The investigators propose to assess the role of a prophylactic single dose (2g) of vitamin C     in reducing the intensity of pain and the consumption of opioids in patients undergoing     laparoscopic cholecystectomy at AUB-MC.      All eligible patients undergoing laparoscopic cholecystectomy at AUB-MC will be included in     the study. Patients will be randomized into two groups to receive either single dose oral     vitamin C (2g) (Study Group) or identically looking placebo capsules (Control Group). Both     the patients and the investigation team will be blinded to the type of intervention.     Intraoperative anesthesia management will be similar for both groups. Postoperative pain     control will be achieved with patient controlled analgesia via a patient controlled morphine     pump in both groups. At several time intervals and up to 24 hours postoperatively, the pain     scores, morphine consumptions, nausea/vomiting scores, sedation scales, itching scales, and     patient satisfaction scales will be obtained for all patients. Also, the peak vitamin C     concentration will be determined for each patient.      Patients demographics will be obtained and compared between both groups. The differences in     pain scores, morphine consumptions, nausea/vomiting scores, and sedation, itching, and     patient satisfaction scales will be compared between the two groups with the Student-t test,     the analysis of variance, the Fisher exact test, and the Kruskal-Wallis test. The peak     vitamin C plasma concentration will be correlated with the pain scores in each group using     regression analysis.      This study will provide relevant information on whether a single dose (2g) of vitamin C can     reduce morphine requirements and non steroidal anti-inflammatory drugs need and thus     eliminating their side effects in patients undergoing laparoscopic cholecystectomy.   "
149892|NCT01322048|"     The investigators intend to determine the effect of adrenergic blockade on 1) short-term     physiology, behavior, and cognition and 2) long-term neuropsychological outcomes after severe     Traumatic Brain Injury (TBI).      The primary hypothesis is that adrenergic blockade after severe TBI will be associated with     increased ventilator-free days.   "
149893|NCT01322035|"     This study compares the improvement of weight, fasting lipid profile (triglycerides,     cholesterol, HDL, and LDL) and diabetes after gastric bypass surgery with an improvement in     levels of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).   "
149894|NCT01322022|"     This study will compare the efficacy of a behavioral parent training program (PT) aimed     specifically at common sleep disturbances compared to parent education (PE) program focusing     on general issues related to autism. In a sample of 40 well characterized young children who     meet criteria for an autism spectrum disorder (24-72 months), the investigators will test     whether the five session PT program is superior to the PE program in decreasing sleep     disturbances.      The primary aim of this study is to evaluate the efficacy and feasibility of a PT program for     sleep disturbance in young children with autism compared to PE.      To this end, there are two hypothesis:        -  Hypothesis 1: After the end of treatment, PT will be significantly more effective than          PE in improving parent reports of a) bedtime struggles and resistance; b) sleep latency;          c) night wakings; d) morning wakings; and / or e) sleep association problems as measured          by the composite sleep index score from the modified Simonds and Parraga Sleep          Questionnaire (MSPSQ; Simond & Parraga, 1982; Wiggs & Stores, 1998).        -  Hypothesis 2: At the end of treatment, children in the PT group (n=20) will display          significantly improved total sleep period as measured by actigraphy in comparison to          children in the PE group (n=20).      The secondary aim of this study is to evaluate the impact of participating in PT on child's     daytime behavior and functioning and parenting stress compared to PE.      To measure this aim, there are 4 exploratory hypothesis:        -  Exploratory Hypothesis 1: Lower Irritability subscales scores will be reported on both          parent and teacher / therapist completed Aberrant Behavior Checklist (ABC) for the PT          group than the PE group at 4 weeks and 8 weeks        -  Exploratory Hypothesis 2: Lower Child Behavior Checklist (CBCL; parent completed) and          Caregiver-Teacher Report Form (C-TRF; teacher completed) scores will be reported for the          PT group than the PE group at 4 weeks and 8 weeks.        -  Exploratory Hypothesis 3: The PT group will have higher scores on the Vineland Adaptive          Behavior Scales: 2nd Edition (VABS-II) at 4 weeks and 8 weeks compared to PE group.        -  Exploratory Hypothesis 4: Parents receiving PT will report significantly lower scores on          the Parenting Stress Index (PSI) at 4 weeks and 8 weeks compared to parents receiving          PE.   "
149895|NCT01322009|"     The overall purpose of this research study is to investigate the safety of pharmacological     therapies that may potentially improve pediatric outcomes after traumatic brain injury.     Traumatic brain injuries are the leading cause of death and disability among children and     young adults.      Hypothesis: Combinational therapy with a membrane transporter and antioxidant are safe after     TBI and can overcome barriers to the brain and synergistically improve bioavailability and     efficacy the antioxidant content of the body and CNS after TBI.   "
149896|NCT01321996|"     The investigators aim to evaluate the role of 68Ga-DOTA-NOC PET/CT in patients with     idiopathic pulmonary fibrosis, in particular in patients with a diagnosis of IPF/UIP     (idiopathic pulmonary fibrosis, diagnosed based in the American Thoracic Society and European     Respiratory Society criteria) and in forms of NSIP (non-specific interstitial pneumonia).     PET/CT imaging data will be compared with HRCT (high-resolution computed tomography) findings     to assess disease extension, early disease detection and to non-invasively detect     somatostatin receptors expression at lung level in these patients, with potential therapeutic     implications.   "
150004|NCT01320852|"     This study aims at testing the utility of PET Scan as a screening tool for liver     transplantation in patients with Hepatocellular Carcinoma. Patients being worked up for liver     transplant for hepatocellular carcinoma will undergo a PET Scan and will be followed until 2     years after transplantation. At that time survival data will be analysed according to PET     Scan results to determine if it can be used to predict outcome.   "
149897|NCT01321983|"     OBJECTIVE: to determine whether preoperative inspiratory muscle training (IMT) is able to     attenuate the impact of surgical trauma on the respiratory muscle strength, in the lung     volumes and diaphragmatic excursion in obese women undergoing open bariatric surgery.      Therefore, the hypothesis of the present study was that preoperative IMT is able to attenuate     the negative effects of surgical trauma on the respiratory muscle strength, in the lung     volumes and diaphragmatic excursion, thus reducing the risk of PPC, in obese patients     undergoing open bariatric surgery.      DESIGN: Randomized controlled trial. SETTING: Meridional Hospital, Cariacica/ES, Brazil.     SUBJECTS: Thirty-two obese women undergoing elective open bariatric surgery were randomly     assigned to receive preoperative inspiratory muscle training (IMT group) or usual care     (control group).      MAIN MEASURES: Respiratory muscle strength (maximal inspiratory pressure - MIP and maximal     expiratory pressure - MEP), lung volumes and diaphragmatic excursion.   "
149898|NCT01321970|"     Our primary goal is to validate a new diagnostic tool for functional coronary artery stenosis     that uses multimodal imaging (combining stress echocardiography and stress scintigraphy) in     patients with known coronary chest pain.   "
149899|NCT01321957|"     The primary objective of this study is to evaluate the efficacy of Irinotecan in combination     with FOLFOX+Bevacizumab versus FOLFOX+Bevacizumab alone in the first-line treatment of     patients with metastatic colorectal cancer.   "
149911|NCT01321801|"     The purpose of this study is to evaluate how effective is the preoperative administration of     pregabalin 600mg, to attenuate postoperative pain and opioids consumption after laparoscopic     cholecystectomy.   "
149900|NCT01321944|"     Tobacco use is the leading preventable cause of death in the United States. Effective     treatment for tobacco dependence exists and includes counseling and pharmacotherapy with     nicotine replacement, bupropion, or varenicline. The health care system is a key channel for     delivering this treatment to smokers. Brief clinical interventions delivered at office visits     increase smoking cessation rates, are among the most cost-effective of medical interventions,     and are recommended by U.S. Public Health Service. However, physicians and other clinicians     often fail to provide them. Clinicians' rates of providing tobacco treatment in ambulatory     care can be improved, but even when successful, clinicians can only reach smokers who make an     office visit.      A health care system might improve its delivery of tobacco treatment by supplementing     visit-based efforts with a population-based strategy, using methods proven effective in     public health settings. A population of smokers could be identified from electronic health     records and offered treatment proactively in a way that maximizes convenience and minimizes     barriers such the cost of pharmacotherapy. This study tests the effectiveness of a     population-based Direct-to-Smoker (DTS) outreach program provided to smokers in one community     health center in Revere, MA, that is part of an integrated health care system. It uses the     system's population management tools to identify smokers and proactively offers them     evidence-based tobacco treatment that is free and does require making an office visit. A     randomized controlled trial will compare the effectiveness of the DTS program to usual     primary care. The hypothesis is that adding the DTS program to usual primary care will     increase the proportion of smokers who use tobacco dependence treatment and thereby stop     smoking.   "
149901|NCT01321931|"     Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A     study in healthy smokers.   "
149902|NCT01321918|"     The main objective of this study is the formation of a DNA bank to realise a case-control     genetic study designed to identify sequence variations in DNA that predispose to sudden     cardiac death in adults.      The secondary objective of this study is the creation of a register for epidemiological     surveillance of adult extra-hospital sudden death.   "
149903|NCT01321905|"     The vast majority of Cystic Fibrosis (CF) patients worldwide are vitamin D insufficient.     There is no evidence of benefit of vitamin D supplementation for CF patients yet. However,     descriptive cross-sectional studies suggest that vitamin D might be beneficial with respect     to bone health, as well as to the newly described non-classical functions of vitamin D such     as the potential anti-diabetic and immunomodulatory effects. To prove causation, and to     determine which serum vitamin D concentration is optimal for CF patients, vitamin D     supplementation interventional studies are needed, such as our trial.   "
149904|NCT01321892|"     The purpose of this research study is to collect information on whether images made using     investigational microscopes can improve researchers' ability to evaluate and distinguish     between normal and abnormal areas in tissue samples surgically removed from patients with     squamous cell carcinoma. The microscopes being used in this study are considered     investigational because they have not been approved by the United States Food and Drug     Administration (FDA) for finding abnormal or pre-cancerous areas.   "
149905|NCT01321879|"     The goal of this clinical research study is to learn if Vibativ (telavancin) can help to     control blood stream infections (BSIs). The safety of this treatment will also be studied.      Objectives:      Evaluate the clinical efficacy and safety of Telavancin given for treatment of gram positive     bacteremia in cancer patients (including neutropenics).   "
149906|NCT01321866|"     The main objective of this study is to evaluate and compare the primary patency rate at 12     months in a group of hemodialysis patients operated on by cutting balloon and in a group of     hemodialysis patients operated by conventional balloon.   "
149907|NCT01321853|"     The purpose of this study is to determine whether a home care medication management program     which includes nurse coordination and use of the MD.2 medication-dispensing machine will     affect older adults' health outcomes, satisfaction, use of health care services, and health     care costs over a one year period. The investigators propose a longitudinal three group     repeated measures design, enrolling, and randomly assigning, clients who are discharged from     a home health care agency with documented problems in medication management. One group will     receive the MD.2 medication dispensing device and nurse coordination, the second group will     receive a Medplanner: a simple box that has separate compartments for individual medication     times over the course of a week plus nurse coordination, and the final group will receive     Usual Care.      The study hypotheses are the following:      H1: With respect to health status outcomes, the MD.2 group will exhibit a more positive     trajectory in physical and mental health status, functional status, cognitive status and     depressive symptoms over the course of a year than will the Medplanner Group.      H2: With respect to health status outcomes, the Medplanner Group will exhibit a more positive     trajectory in physical and mental health status, functional status, cognitive status and     depressive symptoms over the course of a year than will the Usual Care Group.      H3: The rate of hospitalization, hospital days and emergency department visits will be     significantly lower for the MD.2 Group as compared to the Medplanner Group.      H4: The rate of hospitalization, hospital days and emergency department visits will be     significantly lower for the Medplanner Group as compared to the Usual Care Group.      H5: The nursing home admission rate will be significantly lower for the MD.2 Group as     compared to the Medplanner Group.      H6: The nursing home admission rate will be significantly lower for the Medplanner Group as     compared to the Usual Care Group.      H7: The total cost of care will be significantly lower for the MD.2 Group as compared to the     Medplanner Group.      H8: The total cost of care will be significantly lower for the Medplanner Group as compared     to The Usual Care Group.      H9: There will be incremental savings in terms of costs per quality adjusted life year (QALY)     gained in the MD.2 group compared with the Medplanner Group.      H10: There will be incremental savings in terms of costs per QALY gained in the Medplanner     group compared with the Usual Care Group.   "
150005|NCT01320839|"     We hypothesize that: (1) gait stability will be increased when wearing an ankle-foot orthosis     (plastic brace supporting the foot and ankle); (2) an attention demanding task will decrease     gait stability and (3) the improvement in gait stability due to ankle-foot orthosis use will     be greater during an attention demanding task.   "
149908|NCT01321840|"     The aim of the study is to test, if patients suffering from Endometriosis show changes in     their brain function, when being treated with SART (Systemic Autoregulation Therapy), a     complex intervention consisting of interventions from Traditional Chinese Medicine (TCM) and     Western Hypnotherapy. Functional and structural brain changes are assessed using Magnetic     Resonance Imaging data which are analyzed by means of voxel-based morphometry (VBM),     connectivity and perfusion analysis. A third outcome measure are changes of patients' heart     rate variability, indicating the activity of their autonomic nervous system.      With a number of questionnaires, changes in dysmenorrhea, chronic pelvic pain, menstruation     regularity, dyspareunia, defecation pain, and quality of life are assessed during the SART     treatment.      During the treatment, we expect to see changes in cortical thickness, functional connectivity     and perfusion of pain-related areas of the cortex, that correlate with the changes in heart     rate variability.   "
149909|NCT01321827|"     The purpose of this study is to evaluate the efficacy and safety of itraconazole monotherapy     in patients with ABPA.   "
149914|NCT01321762|"     Pelvic organ prolapse (POP) is one of the most common indications for gynaecological surgery.     In 1997, more than 225000 inpatient surgical procedures for POP were undertaken in USA (22.7     per 10000 women) at an estimated cost of more than one billion dollars. In the UK, the     disorder accounts for 20% of the women on the waiting list for major gynaecological surgery.     Vaginal birth, advancing age and increasing body mass are the most consistent risk factors.     Furthermore a racial and congenital predisposition has been reported. The cause of this     disorder is likely to be multifactorial and attributable to a combination of factors, varying     from patient to patient.      Controversy exists as to whether the pregnancy per se rather than the mode of delivery alters     the risk of POP. Caesarean section appears to protect against the development of prolapse.     However, when a caesarean section is undertaken during the active stage of labour it may not     be completely protective. Ideally prospective longitudinal studies are needed to study the     impact of pregnancy and childbirth on pelvic organ prolapse. Unfortunately, studies to date,     are small with poor follow-up and have only assessed objective outcome rendering it difficult     to draw conclusions. The primary objective of our study was to objectively assess the impact     of pregnancy and childbirth on pelvic organ support using the Pelvic Organ Prolapse     Quantification (POPQ)System.   "
149915|NCT01321749|"     This study is a prospective, randomized, single-center trial, designed to observe the effect     of remote limb ischemic preconditioning on ischemic cerebral vascular disease.   "
149916|NCT01321736|"     Dietary fiber is known to influence bowel function. The investigators hypothesize that the     addition of a mixture of fibers to liquid diets will improve bowel function as measured by     stool weight.   "
149917|NCT01321723|"     This study is designed to provide information about the bone anabolic properties and     absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of     24 weeks to postmenopausal women with osteoporosis.   "
149918|NCT01321710|"     The purpose of this study is to test a behavioral intervention to minimize sleep disruption     and fatigue in new mothers after the birth of their first infant. This study also tests     whether an acetaminophen intervention at the time of an infant's 2-month immunization series     improves infant and maternal sleep.   "
149919|NCT01321697|"     This will be a non-blinded, non-randomized study to further our knowledge of and experience     with lymph node surgery. The investigators are interested in documenting and reporting the     variations in leg lymphatic drainage sentinel lymph node biopsy (SLNB) with inguinal-femoral     lymph node dissection (IFLND). The study will be open at the Winthrop P. Rockefeller Cancer     Institute at The University of Arkansas for Medical Sciences (UAMS). Dr. Pamela Stone,     Dr.Alexander Burnett, and Dr. Juan Roman will be responsible for accruing subjects to this     study. It will be open to all patients presenting to the Winthrop P. Rockefeller Cancer     Institute with vulvar cancer requiring lymph node evaluation for the ipsilateral and/or     contralateral groin who have not had prior groin surgery or radiation to the groins. Patients     must meet inclusion and exclusion criteria to be enrolled.   "
149920|NCT01321684|"     For unilateral spinal block, spinal local anesthetics should take effect on the spinal nerves     of one side. With full flexion of the spine, the cauda equina becomes tightened and hangs in     the middle of the subarachnoid space. This study was performed to assess if flexion of the     vertebral column facilitates unilateral spinal anesthesia.   "
149921|NCT01321671|"     The purpose of this study is to evaluate the pharmacokinetics of a single dose of a     pregabalin controlled release (CR) tablet administered fasted in the evening relative to a     single dose of the CR tablet administered immediately following a 600 to 750 calorie evening     meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will     also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR)     capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.   "
149922|NCT01321658|"     This is a randomized, controlled trial on frail elderly patients (aged 65+) with colorectal     cancer. The patients will be randomized into two groups. The control group will receive     standard surgical treatment. The intervention group will in addition go through a     preoperative comprehensive geriatric assessment. The assessment will include evaluation of     co-morbidity and medication, social status, nutritional status, cognition, depression and     physical performance. This assessment will form basis of an individualized perioperative     intervention.      The main aim of the study is to see if the number of postoperative complications in this     group can be reduced by a perioperative geriatric intervention. A study of inflammation     markers in serum will also be performed, with focus on identifying potential biological     frailty markers.   "
149923|NCT01321645|"     Acne is one of the most common skin problems in teenagers and adolescents. There are many     lesser known homoeopathic medicines which have been mentioned in the literature for treatment     of acne but their potential has not been properly assessed /documented and therefore these     medicines don't form a part of many prescriptions. As a part of this study,efficacy of     Azadirachta Indica will be studied in the treatment of Acne vulgaris   "
149924|NCT01321632|"     Acne is one of the most common skin problems in teenagers and adolescents. There are many     lesser known homoeopathic medicines which have been mentioned in the literature for treatment     of acne but their potential has not been properly assessed /documented and therefore these     medicines don't form a part of many prescriptions. As a part of this study, efficacy of     Zingiber officinalis will be studied in the treatment of Acne vulgaris   "
149925|NCT01321619|"     The purpose of this study is to evaluate the efficacy and tolerability of Varicell compared     to Daflon, in reducing the symptoms caused by chronic venous insufficiency and hemorrhoidal     syndrome.   "
149926|NCT01321606|"     The investigators have two hypotheses: (1) The probiotic L. rhamnosus HN001, when compared to     placebo, will reduce S. aureus nasal colonization when taken for four weeks. (2) The     probiotic L. rhamnosus HN001, when compared to placebo, will reduce S. aureus     gastrointestinal colonization when taken for four weeks.   "
149927|NCT01320631|"     The correction of the pelvic organ protrusion is aimed at restoring the pelvic floor     functional status and ultimately improving the patient's quality of life. There are a few     studies that have explored the effect of pelvic reconstructive surgery on female sexual     function (1,2) but no studies have evaluated the male partner's sexual experience. The     investigators intend to use a newly psychometrically validated questionnaire to capture this     aspect. The sexual experience questionnaire (SEX-Q) is the first questionnaire to solely and     exclusively combine functional and quality of life concepts (erection, individual     satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more     focused and less burdensome evaluation of the sexual experience in men (3). Another issue is     the density of the mesh material and if it can be felt vaginally even if it is not eroded and     to what degree this might bother the male partner during intercourse.   "
149928|NCT01320618|"     Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce     in regard to long term outcome. This advanced procedure is offered at Morristown Memorial.     This protocol will review the one year outcome of patients who underwent this procedure using     a polypropylene mesh. These outcomes will include anatomical and quality of life measures.   "
149929|NCT01320605|"     Compound HP802-247 comprises two topical sprays, administered sequentially right after     another; these deliver a suspension of fibroblasts and keratinocytes to the wound surface.     HP802-247 is the subject of a larger Phase 2 multi-center trial for treating venous leg     ulcers. The present study will enroll up to five patients who are suffering venous leg     ulcers, have failed a prolonged course of standard wound therapy and one or more advanced     technologies, but who would not qualify for the Phase 2 study.   "
149930|NCT01320592|"     This study is a phase I, single arm, open-label trial of PD0332991 in combination with     Paclitaxel in patients with Rb-expressing metastatic breast cancer. Up to 20 patients are     anticipated to be enrolled to reach the MTD of PD0332991 in combination with Paclitaxel. Once     the MTD is established, an additional expanded cohort of 10 patients will be enrolled at that     dose to establish the RP2D, obtain additional safety data and perform exploratory biomarker     studies.   "
149931|NCT01320579|"     The purpose of this study is to evaluate dose response, safety, tolerability and efficacy of     2.5% and 5% cis-UCA in comparison to placebo and active comparator in the treatment of adult     patients with moderate or severe chronic atopic dermatitis.   "
149932|NCT01320566|"     The purpose of this study is to assess the long term safety and efficacy of AeriSeal System     treatment administered at up to 4 subsegments during a single treatment session for lung     volume reduction in patients with advanced emphysema through 48 weeks after treatment.   "
149933|NCT01320553|"     The present study will test if administration of different concentrations of 1334H eyedrops     will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or     older.   "
149934|NCT01320540|"     Currently, many breast center patients with a positive family history receive information     about BRCA testing after breast cancer diagnosis, typically after definitive breast surgery     or at a time point that does not allow them to use testing results in making their surgical     decision. Diagnostics, decisions and interventions are often out of sequence, resulting in     test information not available in time for decisions. Tests are often repeated. Decisions and     interventions are delayed, are not understood by breast cancer patients or proceed without     the test information, resulting in suboptimal care and resource waste (Donaldson MS. 2005,     Katz SJ 2007, IOM 2001).      In this study, BRCA testing information will be delivered to patients at the point of breast     imaging. For patients that are diagnosed with breast cancer, this provides ample time to use     the test results in making their surgical decision, if they elect to be tested. The     investigators will work with health care providers to insure family history data are     collected at the breast imaging visit, develop a standardized BRCA patient education handout,     enlist health care providers to insure the information is delivered to the appropriate     patient population, and coordinate scheduling with genetic counseling services to insure     patients are promptly seen.      The investigators hypothesis is that an intervention of providing patients indicated for     genetic/familial risk with timely information and opportunity to access genetic counseling     during breast imaging will shift BRCA testing to before definitive breast cancer surgery, for     patients with a breast cancer diagnosis, and could impact surgical decisions. The     investigators will identify barriers to this intervention from the perspective of patients,     physicians, nurses, and genetic counselors. The investigators will then adjust the     intervention to overcome the barriers and will test the intervention at the point where     genetic/familial risk assessment based on NCCN guidelines is (or should be) conducted at     breast imaging. If indicated, patients will be provided information and will be referred to     genetic counseling to consider BRCA tests.   "
149935|NCT01320527|"     Based on prior published pilot studies, the investigators have initiated a larger, multi-site     placebo-controlled clinical trial with Alzheimer's disease (AD) patients and individuals     diagnosed with Mild Cognitive Impairment (MCI), with the hopes of (1) confirming (or denying)     the above promising clinical findings, and (2) determining whether or not our formulation can     delay MCI conversion to AD.   "
149938|NCT01320488|"     Breast cancer is the leading cancer among women in Saudi Arabia representing almost the third     of cancer diagnosed in Saudi women. Breast cancer in Saudi women is more frequently observed     at young age. The data on this observation is either lacking or scares. Furthermore, the     pathological and molecular features of breast cancer in young women are not clear. The study     will provide important information to the national health care planner about this disease in     young women including shedding light on possible genetic risk factors   "
149939|NCT01320475|"     Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic     and an opioid are generally associated to produce an epidural analgesia. However, opioid     epidural administration is frequently associated with adverse effects as nausea, vomiting,     urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an     effective analgesic.      The purpose of the study is to compare the epidural administration of levobupivacaine and     sufentanil or the epidural administration of levobupivacaine associated with the iv     administration of ketamine.   "
149940|NCT01320462|"     Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by     varenicline and follow up by quit line) in the preoperative clinic is more effective than the     simple preoperative smoking intervention (brief advice and provision of information about the     quit lines ) in terms of short-term and long-term quit rates      Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention     (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in     the preoperative clinic to help surgical patients quit smoking perioperatively and for the     long-term.   "
149941|NCT01320449|"     Epo increases red blood cell production and hence the amount of oxygen that can be     transported around the body. It is shown that prolonged use of synthetic Epo (rHuEpo) leads     to an increase in the period of time a given physical work can be performed, therefore it     will continue to be abused by athletes, especially in endurance sports.      The existing method for measuring the abuse of rHuEpo approved by the World Anti-Doping     Agency (WADA) is based on differences in the sugar groups bound to rHuEpo and Epo produced in     the body, respectively.      Proteomics is a method by which one can look at all the proteins in blood at the same time.     Even proteins that have changed very little can be distinguished. The main objective of this     project is to investigate the effect of prolonged treatment with rHuEpo on changes in blood     proteins in healthy young men.   "
149942|NCT01320436|"     Ulcerative colitis (UC) is a chronic inflammatory disease resulting in increased morbidity in     patients. The current standard treatment for mild to moderate UC (MTMUC) includes     5-aminosalicylic compounds (5ASA) such as olsalazine and mesalamine, yet some patients     continue to experience disease symptoms and flare-ups. These patients require higher dosages     of 5ASA medications and in many cases escalate to steroid and/or immunosuppressant therapy     which comprises higher risk of hazardous side effects.      Curcumin, an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been extensively     studied in the context of inflammatory diseases. In humans, a controlled study using curcumin     as an adjusted therapy to 5ASA medication has shown it to be superior to placebo in     maintaining remission in MTMUC patients . A small, preliminary open label study has also     shown efficacy in reducing disease symptoms and inflammatory markers in this group of     patients .      This data provides bases for investigating an integrative approach to optimize the current     standard treatment in MTMUC patients. We speculate that using a combined therapy of 5ASA     medication and curcumin could benefit this subgroup of patients and reduce morbidity and     perhaps need for escalating pharmacological intervention.   "
149943|NCT01320423|"     To establish whether a policy of earlier surgical evacuation of the haematoma in selected     patients with spontaneous lobar ICH will improve outcome compared to a policy of initial     conservative treatment. The trial will also help to better define the indications for early     surgery.      This will overcome two of the criticisms of STICH (timing was too late and sometimes location     was too deep). The subgroup identified in STICH is clinically sensible and the hypothesis     identified for STICH II is in line with current neurosurgical opinion.   "
149944|NCT01320410|"     The study will comprise two dosing periods in two different cohorts of healthy volunteers.     The investigators will begin with a single dosage period I (1 injection of 25 mg of     Risperidone for each subject); single dosage period II, different from the previous one (1     injection of 37.5 mg of Risperidone for each subject), in a second group of healthy     volunteers different from the first group will not start until after a preliminary analysis     has been made of the safety data and plasma concentration data are known for the formulation     of prolonged release Risperidone using the ISM® technology.   "
149945|NCT01320397|"     The principal aim of the study is to demonstrate that Rostafuroxin is able to induce a more     pronounced reduction of arterial blood pressure respect to Losartan, in hypertensive patients     carrying at least one of the pre-specified gene mutations. In previous studies has been     demonstrated that these mutations are able to induce specific alterations inducing an     increase of sodium (Na) reabsorption at renal tubular level and an increase of arterial blood     pressure. Pilot studies have demonstrated that Rostafuroxin is able to reduce the impact of     these alterations, and so directly reverse the increase in blood pressure.   "
149946|NCT01320384|"     The aim of the study is to compare, in patients with acute respiratory failure/acute lung     injury the efficacy of three different methods of oxygenation to prevent endotracheal     intubation :        1. conventional oxygen therapy (O2 conventional)        2. high flow nasal oxygen therapy (O2-HFN)        3. association of high flow nasal oxygen therapy with non invasive positive pressure          ventilation (O2-HFN/NPPV).   "
149947|NCT01321593|"     The purpose of this study is to compare the hemoglobin results obtained with the Orsense     NBM-200MP device and the Clinical Laboratory.   "
149948|NCT01321580|"     The purpose of this study is to compare the hemoglobin results obtained with the Masimo     Pronto 7 and the Clinical Laboratory.   "
149949|NCT01321567|"     To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton     Pump Inhibitor-resistant reflux esophagitis   "
150162|NCT01318590|"     The purpose of this study is to determine if celiac bloc (with injection of steroid and local     anesthetic) is superior to a sham procedure for pain control and quality of life improvement     in patient with chronic pancreatitis and abdominal pain.   "
151603|NCT01299428|"     The aim of the study is to evaluate cerebral oxygenation with Near infrared spectrophotometry     (NIRS) at the hypernatremic dehydration in newborns.   "
149950|NCT01321554|"     This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare     the progression free survival of participants with 131 I -refractory DTC and radiographic     evidence of disease progression within the prior 12 months, treated with lenvatinib 24 mg by     continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a     Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind     treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment     Period and a follow-up period).   "
149951|NCT01321541|"     The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to     Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma     (DLBCL), or follicular grade 3 lymphoma.   "
149981|NCT01321151|"     Sports-related concussions are a serious problem in football, boxing, and other full contact     sports. After experiencing consecutive concussions, there is an increase in neurological     deficits that can lead to long-term cognitive problems (Dementia pugilistica). To combat this     increase in brain damage, novel strategies need to be developed to protect athletes that are     participating in these full contact sports. The purpose of this study is to elucidate whether     resveratrol decreases brain injury and improves brain function after experiencing a     concussion in boxers.   "
150010|NCT01320774|"     The purpose of this observational study is to evaluate the efficacy, tolerability, quality of     life and handling of Daivobet® Gel by both physician and patient in daily practise.   "
151801|NCT01296802|"     Illicit use of the psychostimulant Ecstasy (3,4-methylenedioxymethamphetamine, MDMA) is     considered a major public health issue. In Switzerland, MDMA and congeners are - after     cannabis and cocaine - number three in the ranking of the most popular illicit drugs.     Worldwide, Ecstasy is estimated to be even the second most popular illicit drug, used by     millions of regular users.      On the basis of animal data, it is likely that MDMA at high or cumulative doses damages     serotonin (5-HT) neurons in the human brain. However, because of a multitude of     methodological problems and a limited number of studies conducted in human subjects, no firm     conclusions can yet be established whether chronic MDMA exposure produces a long lasting 5-HT     deficiency syndrome, with consequent neuropsychiatric risks. To further address the putative     neurotoxicity of MDMA in the human brain, we propose that novel functional assays of     serotonergic neurotransmission may be useful to clarify this issue. We suggest that a 5-HT     challenge study using positron emission tomography (PET) in conjunction with the 5-HT     releaser dexfenfluramine [(+)FEN] may test the functional integrity of the 5-HT system in the     living human brain.      Specifically, in a placebo-controlled study, the 5-HT release capacity of serotonergic     neurons shall be investigated by assessing [18F]-altanserin binding to 5-HT2A receptors     following (+)FEN challenge in former and continuing MDMA users, and age and sex-matched     MDMA-naïve controls. (+)FEN is a potent serotonin releaser without relevant affinity for     5-HT, dopamine (DA) or norepinephrine (NE) receptors, and devoid of acute adverse effects in     man. This makes (+)FEN an ideal pharmacological probe to explore functional integrity of     serotonin neurotransmission.      A second aim of our investigation is to detect possible impairments of cognitive functions     and to study their relationship to serotonin neurotransmission as indexed by PET. In the     course of the neuroimaging study, the investigators therefore also measure cognitive (e.g.     attention, visual and working memory, learning, executive function) and affective functions     (e.g. anxiety, impulsivity), suspected to be altered due to chronic MDMA use. Using     correlational analyses, the investigators aim to determine if circumscribed regions of     altered 5-HT function are associated with specific impairments in cognitive and/or     behavioural parameters.      We hypothesize that (+)FEN-evoked 5-HT release will discernibly alter availability of 5-HT2A     receptors to [18F]-altanserin, with a pattern revealing the spatially heterogeneous     vulnerability of 5-HT innervations to MDMA. The investigators predict that [18F]-altanserin     volume of distribution (DV) will decline following (+)FEN challenge to a lesser extent in     current MDMA users compared to MDMA-naïve control subjects. On the basis of animal data and     recent neuroimaging studies in humans, the investigators hypothesize that functional recovery     in former MDMA users will be manifest by a normalization or overshoot of the 5-HT release     capacity.      Our methodology will allow us to quantitatively assess serotonergic functions in the living     human brain. The novel combination of (+)FEN-induced release of 5-HT from intracellular     storage vesicles and subsequent PET assessment of competitively altered [18F]-altanserin     binding at postsynaptic 5-HT2A receptors will provide a more direct biological marker of in     vivo serotonin function than has been hitherto available. By applying this new     pharmacological challenge/PET neuroimaging approach to groups of current and former users of     MDMA, the investigators shall be able to gain important new insight in the debated functional     consequences of MDMA use, especially concerning the controversy about the reversibility of     5-HT changes following cessation of MDMA use. Successful completion of this project should     have useful implications for public education and harm reduction with respect to MDMA use,     and may also facilitate the development of possible treatment options for chronic MDMA users.   "
168508|NCT00034060|"     This study has two phases. Phase 1 will examine the role of inflammatory mediators called     cytokines on growth hormone levels in women with rheumatoid arthritis (RA). Phase 2 will     evaluate the effect of etanercept on these growth hormone levels. Etanercept is approved for     the treatment of RA. It lowers the levels of a key inflammatory mediator called tumor     necrosis factor-alpha and is very effective in reducing arthritis symptoms.      Growth hormone promotes bone and muscle growth. With aging, people lose muscle mass and bone     strength, possibly because of decreased levels of growth hormone. People with RA have bone     and muscle changes similar to those in older people, perhaps also due to decreased levels of     growth hormone. The first part of this study will see if the inflammatory mediators     responsible for joint inflammation (warmth, redness, pain, and swelling) in RA are related to     the lowered growth hormone levels in this disease. The second part will evaluate the effect     of etanercept treatment on muscle mass and bone density, in addition to growth hormone     levels.      Premenopausal women between 18 and 55 years of age with a recent diagnosis of rheumatoid     arthritis (less than 3 years) are eligible for this study. Healthy volunteers will also be     enrolled in the first phase of the study as control subjects. This study is conducted at two     sites, the NIH and the Johns Hopkins Medical Center in Baltimore.      Healthy volunteers enrolled in this study will be interviewed about their health status and     will fill out questionnaires on diet and general physical function, including fatigue, energy     and well being. In addition, they will be hospitalized once at the NIH Clinical Center for     24-hour blood sampling and will visit to Johns Hopkins Medical Center in Baltimore for a     brachial artery reactivity study, as follows:        -  24-hour blood sampling for growth hormone levels. Blood samples (1/2 teaspoon each) will          be collected every 20 minutes from 8 AM one day until 8 AM the following day through a          plastic tube in an arm vein.        -  Dual energy X-ray absorptiometry (DEXA) scan on a small area of the spine, hip and wrist          to assess bone density and a total body DEXA scan to assess the amount and distribution          of muscle and body fat.        -  Blood vessel (brachial artery reactivity) study to measure the ability of the brachial          artery to dilate and increase its blood flow. For this procedure, the subject lies on a          table with electrocardiogram leads attached to the chest. A blood pressure cuff is          inflated for several minutes and a drop of nasal spray of nitroglycerin is given that          may cause a headache. Blood pressure and headache are monitored and treated as needed.      Patients with rheumatoid arthritis will be seen at the NIH clinic on six separate visits     (weeks 0, 1, 6, 12, 18, and 26) over 26 weeks. Week 0 is a screening visit. At weeks 1 and     26, patients will be admitted to the hospital for 24-hour blood sampling, DEXA scans, and     brachial artery reactivity tests, as described above, plus X-rays of the hand and feet. After     the first visit, they will start taking etanercept, given by self-injection under the skin     (like insulin shots) twice a week. Follow-up visits at weeks 6, 12, and 18 will involve     evaluations of disease activity and drug side effects through joint examination, blood tests,     and questionnaires.   "
149952|NCT01321528|"     The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie     (www.thework.com), trains subjects to reduce their perceived level of stress by self-inquiry     of their thoughts and beliefs connected to stressful circumstances or symptoms. This     meditative process, named The Work, enables the participants to identify and question the     stressful thoughts that cause their suffering. The core of IBSR is simply four questions and     a turnaround, which is a way of experiencing the opposite of what the participant believes.     This process is simple, powerful and can be easily implemented in daily life.      Therefore, on the basis of previous data and beneficial observations the investigators     postulate that the clinical utility of IBSR mediation program may alleviate stress and rate     of burnout and improve quality of life among health care professionals. Thus, we will conduct     a pilot/feasibility Observational study designed to:        -  Assess feasibility of a IBSR intervention by examining attendance, drop-out rates, and          program satisfaction.        -  investigate whether IBSR intervention is efficacious in alleviating stress and rate of          burnout and improving quality of life among health care professionals.   "
149953|NCT01321515|"     The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets     under fasting conditions.   "
149954|NCT01321502|"     The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets     under fed conditions.   "
149955|NCT01321489|"     The purpose of this study is to evaluate the tolerability and safety of Sildenafil Citrate     20mg Sublingual tablet, as well as a possible superiority expressed by the faster onset of     action compared to Viagra ® 50mg tablet Coated in erectile dysfunction.   "
149956|NCT01321476|"     This study will use excess tissue from endoscopic or surgical procedures to examine the     elements of plaque that are found in the carotid walls of patients who have a type of heart     and blood vessel disease called atherosclerosis. Tissue will be collected from patients     undergoing carotid procedures as well as patients undergoing liver and/or intestinal     biopsies. This lab study will examine the different types of proteins that play a role in     developing heart plaque.   "
149957|NCT01321463|"     PH-797804 is an oral ant-inflammatory drug that may reduce the inflammation that is     associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential     safety and efficacy profile in COPD.   "
149958|NCT01321450|"     Including 150 randomised patient, the studies aim is to determine whether an economisation     and/or improvement in terms of operating time, drainage fluid, blood loss, time of     hospitalisation can be found using an ultrasonic dissection device versus traditional     surgical methods such as stitches an ligations.The study is performed for patients undergoing     partial pancreatoduodenectomy.   "
149959|NCT01321437|"     The purpose of this research study is to determine the efficacy of Axitinib in treating     individuals with Stage III melanoma.   "
149960|NCT01321424|"     The purpose of this study is to measure the change in Tear Osmolarity during the course of     the day to support clinical diagnosis of aqueous deficiency or meibomian gland disease and     differentiate between the two forms of dry eye.   "
149961|NCT01321411|"     Respiratory muscles (the muscles used to breathe) need more blood (and oxygen) when their     workload increases. It is difficult to measure respiratory muscle blood flow (RMBF) without     invasive techniques. We will evaluate a new, much less invasive technique to measure RMBF in     2 groups: Healthy Volunteers and Critically Ill patients on breathing machines. The purpose     of this study is to determine the accuracy of this new monitoring technique called Near     Infrared Spectroscopy Utilizing Indocyanine Green Dye when compared with traditional     measurements. The information gained from this study will help us to provide better care to     patients with severe lung problems.   "
149962|NCT01321398|"     Patients with severe lung conditions occasionally require support with a special ventilator     (breathing machine) called the High Frequency Oscillator (HFO). Effective ventilation     requires that the pressure generated by the ventilator be as high as possible but not too     high as this can damage the lungs. In patients on HFO, there is not a well defined way to     measure this pressure. We will insert a small probe into the esophagus of patients on HFO to     see if this is an accurate way to measure lung pressures for these patients. A better     understanding of these pressures could lead to improved patient care.   "
149963|NCT01321385|"     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may     help doctors predict how well patients will respond to treatment.      PURPOSE: This research trial is studying biomarkers in predicting response to treatment in     bone marrow samples from young patients with acute myeloid leukemia.   "
149964|NCT01321372|"     Hematology patients are at high risk for invasive fungal infection (IFI) and are being     treated with voriconazole (VOR) at Princess Margaret Hospital (PMH). It is critical that     patients' serum drug levels are within therapeutic ranges when undergoing treatment. The     primary objective of this study is to determine whether clinical responses     (complete/partial/failure) directly correlate with patients' blood VOR drug levels.      In patients whose disease progression is associated with inadequate voriconazole (VOR) drug     levels, serum drug level determination can allow for dose adjustment, thereby preventing     disease progression. Patients who are extensive metabolizers may have subtherapeutic VOR     levels leading to treatment failure whereas, poor metabolizers may have high drug levels that     cause toxicity. Isoenzyme such as CYP2C19 exhibits genetic polymorphism. Genotyping tests can     also be helpful in determining patient risk subjecting to extreme spectrum of drug levels.   "
149965|NCT01321359|"     Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis     (RHL).   "
149982|NCT01321138|"     Femoral neuropathy after anterior cruciate ligament reconstruction with femoral nerve block     may be as high as 24% at 6 postoperative weeks when evaluated prospectively and     systematically through a clinical neurological and an electroneuromyography (ENMG). It is     still unclear whether this neuropathy is the result of the surgery, especially the     Tourniquet, or the block nerve. The goal of this study is to define the etiology of this     postoperative neuropathy.   "
149983|NCT01321125|"     The physicians have few options for skin antisepsis. Alternatives for common use antiseptics     are costly or ineffective. In order to have more options, this study is needed. The     investigators want to know if there are differences between the use of 2% chlorhexidine     gluconate in 70% isopropyl alcohol or 10% sodium hypochlorite.   "
149966|NCT01321346|"     This study is for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL),     Acute Myelogenous Leukemia (AML), Hodgkin's Disease (HD) or Non-Hodgkin's Lymphoma (NHL).     Panobinostat is a new drug that is considered investigational because it has not been     approved in the United States by the Food and Drug Administration (FDA), or in any other     country. Panobinostat is a histone deacetylase inhibitor (HDACi) and interferes with gene     expression found in cells causing them to stop growing or die. Panobinostat has been used in     several hundred adults who had leukemia, HD, NHL and other solid tumors. Panobinostat has not     been given to children.      This is a phase I study. In a phase I study, drugs are tested to the highest dose that can be     safely given. Drugs are given at gradually increasing dosages until there are unacceptable     side effects. The goal of the Phase I study is to find out the dose of panobinostat that can     be safely given to children with relapsed ALL, AML, HD and NHL.   "
149967|NCT01321333|"     This study will evaluate the effect of single transplantation of HuCNS-SC cells into the     thoracic spinal cord of patients with sub-acute spinal cord injury.   "
149968|NCT01321320|"     The primary hypothesis for this study is that Myostatin and FHL-1 are important in the     development of ICUAP and that changes in activity levels of muscle will modify the levels of     expression and activity of these proteins.   "
149969|NCT01321307|"     Sorend is a water-based formula, which contains carob, melissa and sage. Elder inhabitants of     Israel are known to use carob extract to ease sores in the mouth, due to the tannins which     create a complex with various proteins and polysaccharides, thus creating an impenetrable     layer covering the sores, allowing spontaneous healing.   "
149970|NCT01321294|"     The aim of this study is to compare subjective and objective outcome and surgical side     effects of Nissen and Toupet fundoplication performed in a single institution by only two     surgeons and to compare pre and postoperative findings to healthy individuals.   "
149971|NCT01321281|"     Osteoarthritis (OA) is the most common kind of arthritis and primarily affects the large,     weight bearing joints (including the knees, lower back, hips, neck and the feet) and the     joints in the hands. OA results from the breakdown of cartilage in joints, leading to joint     pain and damage. It affects about 8 million people in the United Kingdom and nearly 27     million people in the United States, most of whom are over the age of 45.      This study aim to determine if Aquamin (as AquaCal and AquaPT) affects molecules of     inflammation in the blood of osteoarthritis and healthy subjects.   "
149972|NCT01321268|"     To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat     deposits and quality of life.   "
149973|NCT01321255|"     The aim of the FOCUS project is to test the Fixed Dose Combination concept for cardiovascular     prevention in populations of different socio-economic characteristics. At the same time,     FOCUS aims to understand the factors determining inappropriate prescribing for secondary     cardiovascular prevention and those for poor patients adherence to treatment. This will allow     FOCUS to establish recommendations for a better use of medication in patients with ischemic     heart disease. In addition, after a successful completion of FOCUS, secondary prevention     medication will be available and affordable for a large number of patients in both developed     as well as developing countries.      There are two Phases in this study:      Phase 1: Is a descriptive, non interventional study. Phase 2: Is an interventional,     randomized trial with prospective economic evaluation.   "
149974|NCT01321242|"     This is a multicenter survey of Russian data on target heart rate achievement in patients     with stable angina and arterial hypertension who are currently treated with beta-blockers for     at least 2 months and with no dose change for a minimum of 4 weeks   "
149975|NCT01321229|"     The sleep respiratory troubles (central apnea or CHEYNES-Stokes dyspnea) are frequent after     stroke. The association of the sleep respiratory troubles with a reserved functional     prognosis is debated. The purpose is to find out the frequency of the sleep respiratory     troubles after stroke in a PRM department and to study their relationship with functional and     neurological recovery.   "
149976|NCT01321216|"     This study aims to determine the contribution of rotavirus infection as a cause of     gastroenteritis requiring hospitalization in children younger than 5 years of age.     Additionally, a secondary aim will be to determine the genotypes of rotavirus that cause     these infections as prevalent in Lebanon.   "
149977|NCT01321203|"     To assess the safety and efficacy of CO2 insufflations during ERCP        1. Primary objective:           To assess the patient's symptoms, abdominal pain and abdominal distension post procedure          (ERCP) in the study group.        2. Secondary objective:      Endoscopist:        -  To assess the adequacy of bowel distension for adequate luminal visualization        -  To assess the peristaltic movement during the ERCP      Anesthetist:        -  To measure the PCO2 level in patient post procedure.        -  To assess the amount of sedation required during the procedure.        -  To assess saturation and vital signs through out the procedure.        -  To assess requirement of buscopan.   "
149978|NCT01321190|"     One way to better understand how various treatments for pain differ is to determine the     effects of these treatments on different pain qualities or characteristics. For example, pain     can be described as hot, electrical, cold, achy, and piercing. In order to     determine which pain quality/qualities that a pain treatment affects, researchers must     develop measures of these pain qualities or characteristics. The purpose of this study is to     learn more about the different pain qualities individuals who have low back pain, headaches     and fibromyalgia experience. Identifying the common qualities of pain experienced by these     groups will help researchers evaluate and develop more comprehensive pain quality measures,     which will ultimately help them to be able to test the effectiveness of treatments for these     different pain qualities.   "
149979|NCT01321177|"     The purpose of this study is to determine how services should be provided to reduce symptoms     and improve life functioning for adolescents and adults who have been recently diagnosed with     schizophrenia.   "
149980|NCT01321164|"     The main objective of the study is to evaluate the additional effect of a narrow band Type B     Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid     esters (FAE) in comparison to FAE monotherapy. The secondary objectives are to evaluate the     effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach     Psoriasis Area and Severity Index (PASI) 75 in comparison to FAE monotherapy and to evaluate     whether a leukopenia and lymphopenia frequently occurring during the FAE treatment is a     positive predictive factor for the treatment response.   "
149984|NCT01321112|"     As is well known, immunosuppressive treatment (IS) after liver transplantation has several     and frequents adverse effects that limit the survival of the graft and recipients. Because of     that, it is desirable that these recipients were able to receive a mild IS regime with a     better safety profile. An attempt to get that aim has been evaluated in several trials in the     past, and consist in to change the IS regime from an calcineurin inhibitors (CNI) based to     another less intense and with less adverse effects based on mycophenolate mofetil (MMF),     which is known to have a better safety profile. The success rate of this strategy(i.e.     complete conversion in absence of rejection) has a wide range from 100% to 50% approximately.     However it is accepted that this strategy is associated with the improvement of several     adverse effects of CNIs such as renal failure and dyslipemia. This study's aim is to perform     IS conversion from CNI to MMF monotherapy and look for transcriptional biomarkers employing a     whole genome expression study performed with microarrays at baseline on liver tissue and/or     PBMCs to try to find a differential gene expression able to correlate with a successful     conversion and thus, to generate a set of transcriptional biomarkers potentially able to     predict the result of the IS conversion on an independent cohort of liver recipients.   "
149985|NCT01321099|"     Iron deficiency (ID) is still a main public health problem in sub-Saharan Africa. Iron     deficient children have an increased risk for anemia which is associated with adverse infant     development that might be partly irreversible. In sub-Saharan Africa, the etiology of ID in     children is multifactoral; but the major causes are low iron dietary bioavailability and     intake from monotonous cereal-based complementary foods. Children < 5 years old can benefit     from iron-fortified complementary foods; however, these fortified complementary foods are     often not adapted to the requirements of children in specific setting. The investigators     developed a complementary food fortificant (CFF) which is added to local porridge and is     deemed to meet the nutrient intake requirement for iron in children 1-3 years of age. The CFF     is lipid-based and can therefore, if regularly used, increase the daily energy intake of     children which is often too low in developing countries with cereal-based diets.      The iron absorption from the mixture of CFF and porridge has to be optimized because it     contains quite a high amount of phytate, a well-known inhibitor of iron absorption. To     optimize iron absorption the investigators are planning three iron absorption studies using     different compounds of iron (FeSO4 + NaFeEDTA), additional vitamin C and phytase, which is     able to degrade phytate. In the first study, iron absorption will be determined from a     mixture of CFF and porridge fortified with 1) 6 mg FeSO4 and 2) 6 mg FeSO4 plus additional     vitamin C. In the second study, the test meals will be fortified with 1) 6 mg FeSO4 and 2) a     mixture of 3 mg FeSO4 + 3 mg NaFeEDTA. In the third study, test meals will be fortified with     1) 6 mg FeSO4, 2) 6 mg FeSO4 plus phytase, and 3) 6 mg FeSO4 plus additional vitamin C and     phytase. Iron absorption will be determined by incorporation of labeled iron into     erythrocytes, 14 days after the administration of a test meal containing labeled iron (stable     isotope technique). Sixty apparently healthy Beninese children 12-36 months of age with a     body weight > 8.3 kg will be included in the study. Additionally, the investigators will test     acceptability of CFFs based on different composition formulas by interviewing the     parents/legal guardians of the children after feeding the CFF for a defined period.      The results of these studies will provide important insights to optimize the iron absorption     of young children from a CFF mixed with local traditional porridge in developing countries.     Furthermore the studies will provide information on the acceptability of CFFs in such a     setting.   "
149986|NCT01321086|"     The investigators are conducting a clinical research trial to determine the role of     motivational interviewing (MI) on promoting home-based walking therapy to improve walking     ability in African Americans with peripheral arterial disease (PAD). African Americans are     more than two times as likely as non-Hispanic whites to suffer from PAD. For patients with     PAD, there is a significant risk for poor walking ability and limb loss. One major treatment     for PAD is walking therapy but the traditional methods for the delivery of this treatment     have required frequent visits to a university or hospital-based site. The investigators will     address the role of self-managed walking program, to be conducted at or near the home, to     improve limb function. In order to motivate the participants to walk, the investigators     included two different intervention strategies: MI and patient-centered counseling for     exercise (PACE). The investigators hypothesize that participants randomized to the MI arm     will have a greater increase in their walking distance, compared to those receiving     Patient-Centered Assessment and Counseling for Exercise (PACE) and the control group.   "
149987|NCT01321073|"     The purpose of the DelIVery for PAH clinical study is to evaluate the safety of the Medtronic     Model 10642 Implantable Intravascular Catheter when used with the Medtronic SynchroMed® II     Implantable Infusion System to deliver Remodulin® (treprostinil) Injection.   "
149988|NCT01321060|"     Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the     treatment for this is controversial. In this study, the investigators aim to evaluate the     different effects of three different treatment protocols which is repeated aspiration,     continuous catheter drainage and conservative treatment. The investigators suppose repeated     aspiration could not only solve acute fluid collections, but also lower the rate of     pancreatic infection.   "
149989|NCT01321047|"     Based on previous results, the investigators considered that sedation quality, complications,     and procedure outcomes may not be different, however, propofol alone titration may have a     fast recovery time than BPS and cost-effectiveness than balanced propofol sedation (BPS). In     present study, the investigators therefore evaluate the time and sedation quality of patient     recovery, cost-effectiveness, complication, and procedure outcomes between propofol alone and     BPS in therapeutic endoscopic retrograde cholangiopancreatography (ERCP).   "
150163|NCT01318564|"     The goal of this clinical research study is to test an investigational type of packaging for     diabetes drugs called unit-dose packaging. Researchers want to learn if unit-dose packaging     can help patients with Type II diabetes to take their drugs on the proper schedule.   "
149990|NCT01321034|"     Objectives.        -  To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg          day of Niacin/Laropiprant in subjects with normal Lp(a) (< 30 mg/dL), high Lp(a) (30-60          mg/dL) and very high Lp(a) (> 60 mg/dL).        -  To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg          day of Niacin/Laropiprant depending on the number of kringle IV-2 repeated copies on the          apo(a) gene. 2.1.1 Hypotheses.        -  The Lp(a) lowering effect of niacin is dependent of the pre-treatment Lp(a)          concentration, with higher absolute and relative reduction in Lp(a) in subjects with          hyperlipoproteinemia(a).        -  Lp(a) size, throughout modifying hepatic synthesis of apo(a), is a major factor related          to the lowering effect variability of niacin in human.   "
149991|NCT01321021|"     This project aims at identifying novel pharmacological targets for the treatment of memory     disorders.   "
149992|NCT01321008|"     The goal of this clinical research study is to learn if radiation therapy and chemotherapy     can help control stage 1 and/or 2 NK cell lymphoma. The safety of radiation and chemotherapy     will also be studied.   "
150009|NCT01320787|"     The goal of this clinical research study is to find out the highest tolerable dose of an     imaging solution called 18-F-fluoroacetate sodium that can be given before a positron     emission tomography (PET) scan. The safety of this solution will also be studied.   "
149993|NCT01320995|"     The main objective of this study is to compare the rate of anal incontinence (measured by the     Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas     with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by     conducting a sphincter ultrasound in the delivery room versus a similar group of women who do     not benefit from screening.   "
149994|NCT01320982|"     The objective of the study is to evaluate the efficacy of Pramipexole, Minocycline and     Aspirin compared to placebo, as add-on to anti-psychotics in the treatment of patients with     schizophrenia.   "
149995|NCT01320969|"     It is well-established that the practice of mindfulness meditation leads to improvements in     mental health and well-being and the cultivation of positive emotions. However, the neural     mechanisms of these improvements are largely unknown. A few recent studies suggest that     mindfulness meditation impacts the structure and function of the ventromedial prefrontal     cortex, the hippocampus, and the amygdala. Interestingly, recent studies have shown that     these regions are part of a brain circuit that is critical for the extinction of conditioned     fear responses, and for the retention of fear extinction memory. Building on the overlap of     these regions and on conceptual considerations, the project investigates whether mindfulness     meditation could influence one's capacity to retain the memory of fear extinction.     Meditation-naïve participants will be randomized to either a mindfulness-meditation based     training or an active control training that controls for all mindfulness-unspecific     components. Participants will undergo a fear conditioning, extinction and extinction recall     protocol in an MRI scanner before and after the trainings. We hypothesize that participants     who have practiced mindfulness meditation will show greater improvements in fear extinction     memory after the course, and that these improvements will be correlated with anatomical and     functional changes in the brain regions of interest. Improvements in fear extinction memory     will also be related to improvements in self-reported psychological well-being. Merging the     fields of an ancient spiritual tradition and a fundamental learning mechanism, the project     investigates the underlying neural mechanisms of a practice for the enhancement of mental     health and well-being.   "
149996|NCT01320956|"     This study aims to find how hypnosis performed just before a painful surgery can change     anxiety level, in children aged 10 to 18 years.   "
149997|NCT01320943|"     The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss     and seroconversion in participants who stop tenofovir disoproxil fumarate (TDF) (Stop TDF     arm) compared to participants who continue TDF (Continue TDF arm).      Only participants who already are on treatment with TDF monotherapy or TDF in combination     with lamivudine or emtricitabine for at least 4 years and who achieved and maintained     virologic suppression (< 400 copies/mL) for 3.5 or more years will be included in this study.     One treatment arm will stop the TDF therapy while the other treatment arm will continue the     TDF therapy. Participants in the Stop TDF arm will be monitored very closely with special     focus on biochemical flares (especially alanine aminotransferase (ALT) increases) and     virological relapses (Hepatitis B viral load increases). If any participant in the Stop TDF     arm exceeds one or more predefined limits for such flares or relapses, TDF treatment will be     reinstituted.   "
149998|NCT01320930|"     The study is a single-center randomized, unblinded, placebo-controlled study to investigate     the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive     pulmonary disease (COPD).   "
149999|NCT01320917|"     Obesity is a disorder associated with metabolic dysfunction and changes in cardiovascular     risk markers; the use of oral contraceptives (OCs) may exert a further negative effect on     these alterations in patients with PCOS.      To assess the effects on arterial function and structure and hemostatic parameters using an     levonorgestrel intrauterine device (IUS-LNG) in women with obesity      A randomized controlled clinical trial.   "
150000|NCT01320904|"     Objective: To evaluate the effectiveness of neuromuscular electrical stimulation (NMES)     combined with closed kinetic chain (CKC) exercises in patients with knee OA.   "
150001|NCT01320891|"     Aim of the study is to ascertain whether a different strategy of fluids administration can be     responsible of differences in terms of acid/base disorders (Stewart approach),     pro-inflammatory and inflammatory mediators. Hence two groups of patients will be treated     either with not-balanced solutions (Normal Saline) or balanced solutions   "
150002|NCT01320878|"     The objective of this study was to assess the efficacy and appropriate dose of iloprost for     inhalation in the treatment of postoperative pulmonary hypertension in children with     congenital heart defects.   "
150003|NCT01320865|"     The investigators hypothesize that bone marrow progenitor cells are mobilized into the     circulation in PAH, home to the lungs and differentiate into mast cells, which promote     vascular remodeling and vasoconstriction through release of renin and chymase. As a corollary     to this, the investigators hypothesize that anti cKit tyrosine kinase inhibitor (TKI),     nilotinib, provides clinical benefit to patients through inhibition of mast cell progenitor     proliferation, mobilization and differentiation. To test this, the investigators will     determine if mast cell progenitors and mast cell biomarkers are related to nilotinib clinical     response. This will be an ancillary study, part of a placebo-controlled, double-blind multi     center clinical trial of nilotinib in pulmonary arterial hypertension.   "
150006|NCT01320826|"     It is hypothesized that primary care colonoscopists are able to achieve benchmarks in     colonoscopy quality including cecal intubation and adenoma detection rates and serious     adverse event rates.      This prospective study is the first in depth analysis of the quality of colonoscopic     procedures performed by primary care physicians at a provincial level in Canada.      In addition, the APC Endo study is the first to directly examine both the quality of     colonoscopy and patient satisfaction in the same study.   "
150007|NCT01320813|"     The main objective is to compare 12 month complication rates between a new surgical method     for thyroidectomy (robot-assisted endoscopic thyroidectomy via a sub-clavical approach) and     open thyroidectomy.   "
150008|NCT01320800|"     This 5-year study addresses the unmet needs of adolescents with social phobia through the     testing of a 12-week cognitive-behavioral, school-based group intervention delivered by     trained school counselors compared to a nonspecific school counseling program. A secondary     goal is to provide further examination of the efficacy of the CBT program delivered by school     counselors as compared to the same program delivered by psychologists.   "
150011|NCT01320761|"     To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately     following injection and at regular intervals up to 24-hours post-injection following     subcutaneous administration into the submental area.   "
150012|NCT01320748|"     The purpose of this study is to determine whether drug-dependent adults who participate in a     dual processing relapse prevention treatment protocol that allows for sensory-based exposure     experiences over 10-weeks in outpatient treatment will show significant brain change related     to diminished cue reactivity, and greater improvement in self-efficacy, anxiety,     somatization, and treatment retention, as compared to the standard care patients in a relapse     prevention program.   "
150013|NCT01320735|"     The objective of this study was to describe treatment patterns of leuprorelin over 2 years     using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)   "
150014|NCT01320722|"     The investigators hypothesize that, among non-hypertensive overweight and obese individuals,     treatment of vitamin D deficiency and lowering uric acid concentrations (by either xanthine     oxidase inhibition or increased renal excretion) will attenuate renin angiotensin system     (RAS) activation, improve endothelial function, and lower blood pressure.   "
150015|NCT01320709|"     In this study the effect of piroxicam on the ovulation will be evaluated. Therefore piroxicam     will be administered as a single-dose after onset of LH surge (luteinizing hormone, hormone     which triggers ovulation).      Additionally blood levels of endogenous hormones (hormones produced by your body) will be     measured and transvaginal ultrasound examinations will be conducted at regular intervals. In     addition the concentration of piroxicam in blood will be determined in regular intervals.      With regards to the tolerability of the study drug subjects will be asked regularly how they     feel.   "
150016|NCT01320696|"     The purpose of the study is to identify the optimal dose level of a reverse genetic (RG)     reassortant H9N2 pandemic influenza vaccine for further product development.   "
150017|NCT01320683|"     This phase II trial studies how well giving combination chemotherapy and bevacizumab before     surgery and radiolabeled monoclonal antibody therapy works in treating liver metastases in     patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as leucovorin     calcium, fluorouracil, and oxaliplatin (FOLFOX), work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the     ability of tumor to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90     DOTA anti-CEA monoclonal antibody M5A, can find tumor cells and carry tumor-killing     substances to them without harming normal cells. Giving chemotherapy and monoclonal antibody     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs     to be removed. Giving radiolabeled monoclonal antibody therapy after surgery may kill any     tumor cells that remain after surgery   "
150018|NCT01320670|"     Epilepsy, defined as recurrent, unprovoked seizures, is a common condition, affecting 0.5-1%     of the general population. People with uncontrolled epilepsy suffer poor health and increased     mortality due to their condition. They frequently experience social stigma and are     socioeconomically disadvantaged. It is therefore imperative to help them gain control of     their seizures as quickly as possible. A wide range of antiepileptic drugs (AEDs) has become     available to treat people with epilepsy. However, despite maximal therapy, approximately     20-40% show pharmacoresistance (PR) and thus continue to have seizures.      We do not understand why a significant proportion of people with epilepsy have PR. For any     given patient presenting with a first unprovoked seizure, we are unable to predict PR at the     time of presentation. At least 2 different AEDs must be tried at maximum doses for a year     before we can diagnose PR. At this point, surgical therapies become an increasingly urgent     consideration.      Retrospective magnetic resonance imaging (MRI) studies in the chronic stages of epilepsy have     shown that patients with PR are more likely to have focal structural lesions in the brain,     and in particular to have signs of damage to the hippocampi. For example, there are     retrospective data suggesting that a decreased hippocampal N-acetylaspartate (NAA)/creatine     ratio (measured by magnetic resonance spectroscopy [MRS]) and hippocampal atrophy (determined     by hippocampal volumetry) correlate with PR. However, it is not clear whether these findings     reflect the underlying pathophysiology of PR, or simply reflect the effects of chronic     seizures and chronic drug treatment on the brain.      The First Seizure Clinic at the Halifax Infirmary represents a unique opportunity for     prospective, longitudinal studies of patients who present with a first seizure or with newly     diagnosed epilepsy. In these patients, advanced neuroimaging techniques at presentation might     show changes that truly reflect the underlying pathophysiology of PR, rather than changes     that develop as a consequence of prolonged seizures and drug treatment. Neuroimaging     follow-up might help us to understand the pathophysiologic changes that accompany the     evolution of PR. Ultimately, it is our hope to combine neuroimaging features and clinical     features of patients with PR in a predictive model that would help us to predict PR at     presentation.   "
150051|NCT01319981|"     The goal of this clinical research study is to learn if intensive chemotherapy (hyper-CVAD     therapy) given in combination with liposomal vincristine (Marqibo), in addition to rituximab     for patients who are CD20 positive and/or imatinib or dasatinib for patients with the     Philadelphia (Ph) chromosome, can help to control ALL or lymphoblastic lymphoma. The safety     of this treatment will also be studied. CD20 is a protein marker that is found in leukemia     or lymphoma cells.   "
150019|NCT01320657|"     This is a clinical study involving patients undergoing orthodontic treatment with fixed     appliances ('train-track braces'). A new type of train-track has recently been marketed. Over     4 million patients worldwide are wearing on of these appliances; this system is considerably     more expensive than a normal train-track. However, there is little evidence to support its     use.      The effects of three different types of train-track will be assessed with respect to the     quality of Orthodontic tooth movement produced. Furthermore, the impact of the different     train-tracks on daily life of orthodontic patients will also be measured. Consequently, the     investigators will be able to inform orthodontists' decisions relating to the choice of     train-track they recommend for their patients. In addition, should the more expensive     appliances demonstrate objective or subjective advantage, a significant efficiency saving may     develop.   "
150020|NCT01320644|"     Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce     in regard to long term outcomes. This advanced procedure is offered at Morristown Memorial.     THis protocol will review the one year outcome of patients who underwent this pocedure using     a polypropylene mesh. These outcomes will incude anatomical and quality of life measures.   "
150075|NCT01319669|"     To assess the efficacy and safety of administration of rhTPO at different time in the     treatment of thrombocytopenia caused by first-line GC/GP regimen for non small cell lung     cancer (NSCLC)   "
150190|NCT01318148|"     The study is a pilot phase II, prospective, non-comparative, single center trial aimed to     evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal     prophylaxis in high risk patients.   "
150021|NCT01320371|"     The purpose of this prospective study is determine if barbed sutures are more efficient, have     comparable complication rates, clinical outcomes, and cosmesis outcomes versus traditional     knotted sutures when used in the closure of primary total knee arthroplasty (TKA).      Barbed suture has been associated with improved closure efficiency and safety in TKA in prior     studies. The investigators performed a multicenter randomized controlled trial to determine     the efficiency and safety of this technology in TKA. The investigators prospectively     randomized 411 patients undergoing primary TKA to either barbed running (n=191) or knotted     interrupted suture closure (n=203). Closure time was measured intraoperatively. Cost analysis     was based on suture and operating room time costs.   "
150022|NCT01320358|"     The main purpose of this exploratory trial is to evaluate the reliability, safety and     usability of the Transplantation Sensor System when the Ingestible Event Marker (IEM) is     given in combination with ECMPS 360 mg tablets in adult renal transplant recipients.   "
150023|NCT01320345|"     The purpose of this study is to evaluate the potential benefits of Fenofibrate in 300 adults     with Type 1 diabetes mellitus who are at high risk of eye damage.   "
150024|NCT01320332|"     The purpose of this study is to determine the pharmacokinetics (PK) and to assess safety and     tolerability of a single dose of ASP3291 in subjects with ulcerative colitis.   "
150025|NCT01320319|"     Primary Aim is to test the Hypothesis: Nutritional supplementation with 960mg EPA three times     a day positively affects muscle function and mass (assessed by muscle biopsies, assays of     cellular aerobic function and DEXA scan) and inflammation (measuring cellular markers of     inflammation) in patients undergoing resection of colorectal cancers.      The secondary aim is to evaluate aerobic performance assessed by cardiopulmonary exercise     testing (CPEX) and perioperative outcome in patients with colorectal cancer post surgical     resection.   "
150026|NCT01320306|"     The prevalence rate of intracranial aneurysms in the adult population is close to 5%. Rupture     risk of such aneurysms causing subarachnoid hemorrhage (SAH) can be substantial.Most patients     suffering from an aneurysmal SAH are in their mid life, i.e., 30 to 60 years old. Aneurysmal     SAH may cause disability and mortality. The present study includes a follow-up study and a     cross-sectional fMRI study. The purpose of the follow-up study is to monitor patients     receiving prophylactic surgical treatment of their un-ruptured aneurysms to examine whether     such treatment is associated with cognitive, psychosocial and/or neurologic sequela. The     purpose of the cross-sectional fMRI study is to examine the relationship between memory     function and brain activity among SAH patients. Memory impairment is often found among     aneurysmal SAH patients. Using fMRI can possibly shed some light on whether such memory     impairment may be caused by diffuse cerebral damage or a focal damage at the aneurysm site.   "
150027|NCT01320293|"     Severe psoriasis has been demonstrated to be associated with decreased endothelial function     and an increase risk of future coronary events. Although systemic therapy with     immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic     inflammation and endothelial function are unknown.      In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and     inflammatory markers before and after treatment of moderate to severe psoriasis with an     FDA-approved biologic agent, adalimumab (Humira).   "
150028|NCT01320280|"     The purpose of this study is to find out what effects, good and/or bad, BIBW 2992 (Afatinib)     has on patients and their advanced prostate cancer which does not respond to hormone or     chemotherapy any more. Only patients with tumors which have an increased amounts of a protein     called HER2 on their cell surface will be included.      BIBW 2992 (Afatinib) is a drug which in advanced clinical testing in lung and breast cancer.   "
150029|NCT01320267|"     The investigators will document the success for completing laparoscopic resection of cancer     in the right colon using a new single port access technique. The current procedure requires 4     incisions for 4 separate ports. With technological advancement of newly designed instruments     it is now possible to do the same laparoscopic procedure through a single port. The     investigators want to demonstrate here in British Columbia that it is a safe procedure with     similar success and outcomes compared to the standard 4-port laparoscopic operation.      The investigators propose that this procedure may provide early discharge due to less pain     and also be associated with less wound infection and hernia complications. The single     incision will have improved cosmesis compared to the standard 4-port standard laparoscopic     procedure.   "
150030|NCT01320254|"     The purpose of this study is to determine the efficacy of panitumumab plus     cisplatin/gemcitabine (CisGem) combination chemotherapy in KRAS wild-type biliary tract     cancer patients without systemic pre-treatment, compared to the historical data and to the     randomised control group without the antibody, which verifies the historically based     assumption.   "
150086|NCT01319526|"     RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment     with HIV infection and Hodgkin lymphoma may help doctors learn more about the effects of     therapy on HIV.      PURPOSE: This research study is studying biomarkers in blood samples from patients with HIV     infection and stage III or stage IV Hodgkin lymphoma undergoing chemotherapy.   "
150164|NCT01318551|"     Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single     dose group stratified study in renal impaired and healthy subjects.   "
150031|NCT01320241|"     Malignant biliary obstruction is a common clinical condition caused by various malignancies.     Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the     most important methods for relieving malignant biliary obstruction. However, the benefit for     the survival of the patients with palliation of the stent treatment is limited because no     therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by the     success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded with     125I radioactive seeds has been developed in our institute. After ex vivo and in vivo     evaluations for the delivery system, the investigators prospectively compare the responses to     treatment with this radiation biliary stent, versus the conventional biliary SEMS in patient     with malignant biliary obstruction.   "
150089|NCT01319487|"     The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low     dose) administered in the eye are more effective than placebo in treating patients with     diabetic macular edema, following 12 weeks of treatment.   "
150288|NCT01316848|"     This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of     1.5 mg tivozanib in normal healthy subjects.   "
150032|NCT01320228|"     The objective of the Orlifat trial is to investigate if dietary fibres from linseeds and     dairy calcium (Capolac ®) may reduce gastrointestinal side effects related to increased fecal     fat content, induced by treatment with Alli® (orlistat). Secondly, effect on food intake,     anthropometry, Quality of Life and cardiovascular risk markers will be evaluated. The trial     is designed as a randomised 2 x 2 factorial 13-weeks parallel intervention, in which 72 obese     participants will be randomised to supplementation with flaxseed fibres and/or dairy calcium     concentrate (Capolac) in addition to treatment with Alli ®:        1. Alli® (60 mg t.i.d) plus placebo (rice flour)        2. Alli® plus 5 g flaxseed fibers        3. Alli® plus 1200 mg Ca from Capolac        4. Alli® plus 5 g flaxseed fibers and 1200 mg Ca from Capolac   "
150033|NCT01320215|"     The primary objective of this study is to compare 30-day complication rates associated with     promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic     technique versus a non-robot-assisted laparoscopic technique. Secondary objectives include     comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality     of life and medico-economic data between the two techniques.   "
150034|NCT01320202|"     The purpose of this study is to confirm the safety and efficacy of Soluble Ferric     Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in     anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will     be measured primarily by the change from baseline in hemoglobin (Hgb).   "
150035|NCT01320189|"     The objective of this study is to determine ad libitum daily energy and protein intake,     energy balance and appetite profile in response to protein/carbohydrate and fat ratio over 12     consecutive days, also as a function of age, gender, BMI and FTO polymorphisms.   "
150036|NCT01320176|"     This study aimed to evaluate the safety and reactogenicity of two intramuscular injections of     two different dosages of an investigational clade B HIV vaccine.   "
150037|NCT01320163|"     This study is designed to determine whether a functional difference exists between the     laryngeal mask airway (LMA)-Classic™ and i-gel in anesthetized children who have received     neuromuscular blockade.   "
150038|NCT01320150|"     Osteoarthritis (OA) is the single most common cause of disability in mid and late life. About     27 million people in the United States suffer from this incurable process and 10 million have     OA of the knee. Total knee replacement (TKR) is a reliable treatment option for patients     disabled by knee OA who have failed non-operative treatment; 58% of these surgeries are     performed on patients 65 years or older. Despite the overall success of TKR in most cases,     persistent postsurgical pain (PPP) of the operated knee remains a common and often difficult     to treat postoperative outcome affecting 13-20% of all patients at 6 months post-TKR, which     amounts to 65,000-100,000 patients/year in the USA. Important secondary outcomes of PPP are     restricted physical mobility and poor quality of life, especially in older patients.      Recent findings spanning the pre-, intra- and postoperative periods suggest that the     development of PPP after TKR is a multi-factorial process, comprised of both neurophysiologic     and psychosocial factors. Likely determinates include preoperative thermal pain sensitivity,     anxiety, pain catastrophizing; and postoperative area of secondary mechanical hyperalgesia or     hypoalgesia (numbness). There is already agreement that the intensity of early (acute)     postoperative pain is one of the factors predicting PPP. To date, most studies have examined     the role of risk factors in isolation and/or within a single domain, and no prospective study     has comprehensively evaluated the interaction of neurophysiologic and psychosocial variables     in the evolution of PPP following TKR. The lack of information regarding how neurophysiologic     pathways and patient cognitive/affective states interact over time following otherwise     successful TKR has greatly undermined the understanding of PPP after TKR.      The proposed project is a single-site, prospective study of 300 OA patients aged 18-85 yrs     undergoing primary TKR. The study is designed to identify factors from the pre-, intra- and     postoperative phases of TKR that contribute to PPP at 6 months. Specific risk factors were     selected because they are potentially modifiable, and therefore may be amenable to     intervention. Patients will be assessed from pre-surgery to 6 months post surgery. The     proposed multi-factorial and prospective approach to investigating risk factors is a vital     next step towards understanding the complex phenomenon of PPP.   "
150039|NCT01320137|"     The purpose of this study is to develop and characterize immunological assays on blood     samples.   "
150040|NCT01320124|"     A contracture is a pathological condition limiting range and function of joints. Contractures     of large and small joints alike will affect one's ability to independently perform daily     activities such as eating, dressing or walking. Current treatments for contractures include     physical stretching, the use of assistive devices or, rarely, surgery. Despite prolonged     treatments, patients with contractures rarely regain complete mobility. Progress in     preventing and treating contractures will be possible only through an understanding of the     biological and molecular processes involved. Our group has established and validated an     animal model to study the histological events and the molecular mechanisms involved in joint     contractures. We have provided evidence for capsule stiffness, characterized cartilage     degeneration, and identified four genes whose expression is altered in the cartilage of a     knee joint with contracture. The work we propose in the current study aims at finding genes     and pathways in the joint capsule associated with knee joint contractures. The results will     identify new avenues for treating the large number of patients suffering from contractures.   "
150041|NCT01320111|"     AIM OF STUDY      Primary Efficacy Variable:      The primary study objective is the proof of efficacy, measured by progression free survival     (PFS) in the treatment of metastatic or locally inoperable recurrent breast cancer.      Progression-free survival (PFS) is defined as the time from randomisation to disease     progression or death.      Secondary Efficacy Variables:        -  Clinical benefit (CR+PR+SD)        -  ORR (CR+PR)        -  Time to progression        -  Time to next Treatment (TTT)        -  Overall survival        -  Safety profile   "
150142|NCT01318863|"     More than one site will participate in the collection of blood and urine samples from healthy     adult subjects. These samples will be used for future testing to serve as aged-matched normal     controls and to establish normal reference ranges in the development of new invitro     diagnostic devices.   "
154457|NCT01262118|"     The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol     metabolism in patients with active rheumatoid arthritis (RA).   "
150074|NCT01319682|"     This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine     injection on the relief of pain in patients undergoing 1-level posterior lumbar fusion.      A total of 54 patients will be randomized into one of two groups (group C or group I) based     on Excel number generation.      Patients in group C will receive received normal saline intravenous injection, and patients     in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a     continuous lidocaine infusion of 2 mg/kg/hr.      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12,     24, 48 hours postoperatively.   "
150042|NCT01320098|"     The purpose of this research is to evaluate and compare the effectiveness of two parenting     programs in reducing the ADHD symptoms and behavioral problems of preschool children with     ADHD through a controlled study. One program is a home-based parent training intervention     that is designed to enhance the parent-child interaction, constructive parenting skills, and     the child's tolerance for delay. The other intervention is a clinic-based parent training     program that focuses on reducing noncompliance in preschool children and improving parenting     skills.      Both programs consist of private weekly parenting sessions with Clinical Psychologists - once     a week for 8 weeks. The sessions are 1-1.5 hours in length. Both programs use behavior     modification as a means of improving oppositional and non-compliant child behavior. Both     interventions also involve procedures that focus on improving children's attention.      Neither program involves medication, and all families will receive one of the two parenting     programs being evaluated. Study evaluations, as well as participation in the parenting     programs, are provided at no cost to families. Evaluation and parenting sessions can be     scheduled at times convenient to families.   "
150043|NCT01320085|"     The study will assess the safety and efficacy of single-agent MEK162 in adult patients with     locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring     BRAFV600E or NRAS mutations.   "
150044|NCT01320072|"     To diagnose aspirin hypersensitivity in asthmatics by using and safe, low-dose aspirin oral     challenge.      Hypothesis 1: A low dose of oral ASA (20 or 40 mg) will induce significantly different     concentrations of arachidonic acid metabolites in ASA-sensitive asthmatics as compared to     ASA-tolerant asthmatics.      Hypothesis 2: The low dose (20 or 40 mg) ASA challenge will be well tolerated by     ASA-sensitive asthmatics.   "
150045|NCT01320059|"     The goal of this clinical research study is to learn if an imaging solution called     18F-PEG6-IPQA can help to find tumors when used in positron emission tomography (PET) scans.     The safety of the solution and how the solution is processed by your body will also be     studied.   "
150046|NCT01320046|"     Vulvar contact dermatitis (VCD) is a common problem presenting as vulvar pruritus, burning or     irritation. Its estimated prevalence is 20-30% in vulvar clinics, but the prevalence in the     general population is unknown.      Contact dermatitis is an inflammation of the skin resulting from an external agent that acts     as an irritant or as an allergen. The skin reaction may be acute, subacute or chronic,     resulting from prolonged exposure to weak irritating substances.      The most common form of VCD is irritant contact dermatitis, and it usually presents as vulvar     itch. The causes that contribute to VCD are increased sensitivity of the vulvar skin to     irritants compared to other body parts, decrease in the skin barrier function due to exposure     to sweat, urine and vaginal discharge and constant friction of the vulvar area. In menopausal     women, lack of estrogen contributes to tissue atrophy and thinning, and may increase the     effect of irritants on the vulvar skin.      One of the most common irritating substances that cause VCD is urine. The phenomenon of     urine-induced VCD is known as diaper rash in babies, and it was also described in bedridden     patients using diapers constantly. Women with urine incontinence (UI), a problem that its     prevalence in women increases with aging, may use constantly panty liners or pads to prevent     urine leakage. The urine is being absorbed in the pad, and the vulvar skin is continually     exposed to urine. This can cause VCD, similar to diaper rash. The prevalence of this     phenomenon in the general population is unknown.      The patients complain of itch, burning or irritation of the vulvar skin, and on exam     erythema, edema and irritated skin are found. As most patients do not connect between UI to     their vulvar disorder, and as most care-givers do not ask routinely about UI, the vulvar     symptoms are mistakenly attributed to yeast infection or other factors. As the cause to the     vulvar complaints is not recognized, patients do not receive proper treatment that requires     primary management of UI.      The aim of the study is to evaluate the prevalence of VCD in women with UI and to recognize     risk factors for UI induced VCD.   "
150047|NCT01320033|"     The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for     16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry     Forward, Intent To Treat) in inflammatory lesion counts.   "
150048|NCT01320020|"     The study is designed as an open-label dose-escalation study to investigate the safety and     tolerability of catumaxomab qwk in patients with epithelial cancer. The treatment period for     dose escalation (dose limiting toxicity (DLT) period) consists of 4 weeks, comprising 4     single i.v. administrations of catumaxomab followed by 1 week for safety observations after     each administration. All patients will be offered continuation of catumaxomab treatment at     the same dose until disease progression or death, whichever occurs first.   "
150049|NCT01320007|"     Heart failure is a major clinical problem that is increasing in magnitude and the cost of     management of heart failure is escalating. A significant part of this cost is related to     unplanned acute presentation to emergency departments and hospitalisation with worsening     shortness of breath due to increased fluid content in the lungs.      Many heart failure patients are already fitted with defibrillators to protect them from the     risk of fast heart rhythms and sudden death and are followed up in both the heart failure     clinics and defibrillator clinics. Recently some of the defibrillators fitted have been     equipped with an extra function that can detect and warn of changes in the fluid content of     the lungs very early even before the patient starts to complain of any shortness of breath     and before any signs of fluid overload are seen clinically. However, it is not known how to     deal with these warnings if they occur very early and it is not known whether a medical     intervention at his stage is beneficial to prevent progression and eventual hospital     admission. In the majority of cases, early warnings of this kind are ignored or this function     is disabled at implantation of the device.      The current study will involve patients who have already been fitted with a device with the     above capability. The investigators will use the new function to guide management of these     patients and compare their outcome with similar patients who are fitted with devices without     it. The investigators will attempt to manage early warnings by a predetermined increase in     medications in a group of patients and compare their clinical course to a similar group in     whom no action is taken.   "
150050|NCT01319994|"     According to current estimates, nearly 1% of the general population is treated with long-term     glucocorticoids. Chronic hypercortisolism leads to a phenotype that resembles the metabolic     syndrome. The investigators have shown that inhibition of adenosine-monophosphate-activated     protein kinase (AMPK) activity in adipose tissue plays a role in corticosteroid-mediated     insulin resistance. Metformin, one of the mainstay therapies for type 2 diabetes, is a known     activator of AMPK, which mediates its beneficial effects on glucose and lipid metabolism. The     investigators have shown in an animal model that metformin - via altering AMPK activity -     prevents the development of the metabolic complications of glucocorticoid excess, and the     investigators wish to confirm this in a human study. The aim of this prospective, randomised,     double-blind, placebo-controlled study is to investigate the effect of metformin treatment on     metabolic parameters in patients on long-term high-dose glucocorticoids. The study is part of     the investigators translational project and could rapidly lead to immediate patient benefit,     improving quality of life and reducing health care costs for the NHS.   "
150052|NCT01319968|"     Postpartum dyspareunia (PD) is a recognized phenomenon: it is estimated that 50-60% of women     have dyspareunia 6 to 7 weeks following delivery, and 33% and 17% will still report pain     during intercourse three and six months after delivery, respectively.      Studies that evaluated the prevalence and the causes for PD referred primarily to obstetric     trauma, such as vaginal tears, episiotomy, the mode of repair and damage to the pelvic floor     muscles as probable causes for PD. These studies did not refer to estrogen deficiency and the     possible effect of breastfeeding on vaginal atrophy and its contribution to PD. Comparison     between vaginal deliveries and cesarean sections revealed that there is no difference in the     prevalence of PD between the two groups, and according to these findings it can be assumed     that the mechanical trauma to the vagina and pelvic floor during delivery is not the main     cause for the development of PD.      Vaginal atrophy due to estrogen deficiency is a common cause for postmenopausal dyspareunia.     With estrogen deficiency, profound changes occur in the vagina: vaginal mucosa becomes thin     and pale or hyperemic and loose her flexibility. Blood flow decreases, normal vaginal     discharge is reduced, and maturation of epithelial cells do not take place in the absence of     estrogen. Women with estrogen deficiency may complain of dryness, pruritus, irritation,     burning, dysuria, pain and dyspareunia. These changes are reversible by estrogen, given     systemically or topically, and cause resolution of clinical findings, as well as     disappearance of symptoms in several weeks.      Similar to postmenopausal patients, breastfeeding women immediately after delivery,     experience decline of estrogen levels, and this decline may persist as long as lactation is     continued. Therefore, many women after delivery may experience vaginal atrophy due to     transitional lack of estrogen. It is possible that this atrophy is the cause for the high     rate of PD.      Our clinical experience shows that many women present with postpartum dyspareunia with     vaginal atrophy, and that vaginal atrophy is responsible for part or most of their     complaints. Although most gynecologists recognize atrophy easily in menopausal women, vaginal     atrophy is not recognized correctly in most puerperal patients and therefore do not receive     attention and proper treatment.      The aim of the study is to characterize the phenomenon of postpartum vaginal atrophy in terms     of prevalence, risk factors and duration, and the association between vaginal atrophy and     postpartum dyspareunia.      We also intend to evaluate the effect of vaginal treatment with estriol cream 0.1% (Ovestin     cream) on postpartum dyspareunia.      The study will expand our knowledge regarding postpartum dyspareunia and will enable     formulating recommendations for evaluation and treatment of PD.   "
150053|NCT01319955|"     Pneumonia is the leading cause of child death worldwide. Data from Bangladesh indicates that     influenza has a substantial association with pneumonia among children less than two years     old. This study will use commercially available trivalent inactivated vaccine (killed     vaccine) to see if it can prevent early childhood pneumonia among children less than two     years old. The study will vaccinate children across three seasons (3 years), and look at the     effect on the attack rate of pneumonia, as well as its effects on laboratory-confirmed     influenza. It will also look at the effect on laboratory-confirmed influenza illness among     the non-vaccinated household contacts of all ages of these children.   "
150054|NCT01319942|"     This study aims to test the efficacy of combined radiotherapy and sorafenib in patients with     locally advanced hepatocellular carcinoma.   "
150055|NCT01319929|"     To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of     LY2828360 in male and female subjects with osteoarthritic knee pain   "
150056|NCT01319916|"     Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following Subcutaneous     Injection of ATX-101 into Abdominal Fat Tissue   "
150057|NCT01319903|"     The novel humanized monoclonal antibody CaCP29 was developed to control the inflammatory     response to various stimuli in humans and espacially during sepsis. Purpose of this phase I     clinical trial in healthy human males is to investigate various parameters concerning safety     and tolerability of CaCP29 and assess pharmacokinetic and pharmacodynamic parameters.   "
150058|NCT01319890|"     Current evidence regarding the optimal surgical approach to potentially curable right colonic     cancer is based on numerous, well designed randomised controlled clinical trials. Currently,     eminence based opinion suggests that an alternative surgical technique, single incision     laparoscopic surgery (SILS), may improve short and long term outcomes after minimally     invasive right colonic resection. A true, prospective analysis comparing standard of care     (laparoscopic right hemicolectomy) and this new therapy(SILS) has yet to be published.     Having established the optimum treatment modality the minimally invasive approach to right     colonic tumors the results will be communicated at national and international meetings.   "
150059|NCT01319877|"     This observational study will evaluate the safety and efficacy of Bevacizumab in combination     with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese     participants with metastatic colorectal cancer. Data will be collected from each participant     for up to 3 years.   "
150060|NCT01319864|"     In this Phase I study, we will test the safety of the drug plerixafor (MOBOZIL) at different     dose levels, used together with other anti-cancer drugs—cytarabine and etoposide. We want to     find out what effects, good and /or bad, this combination of drugs has on leukemia.     Plerixafor is a drug that blocks a receptor on the leukemia cell, which prevents it from     staying in the bone marrow where it can be resistant to chemotherapy. Plerixafor is FDA     approved for mobilizing stem cells from the bone marrow in preparation for an autologous stem     cell transplant. Cytarabine and etoposide have been used as part of standard chemotherapy for     ALL and AML. However, the use of plerixafor with cytarabine and etoposide in pediatric     patients with relapsed or refractory ALL, AML and MDS is considered experimental.   "
150061|NCT01319851|"     Allogeneic blood and marrow transplantation remains the only viable cure for children who     suffer from many serious non-malignant hematological diseases. Transplantation, however,     carries a high risk of fatal complications. Much of the risk stems from the use of high dose     radiation and chemotherapy for conditioning, the treatment administered just prior to     transplant that eliminates the patients' marrow and immune system, effectively preventing     rejection of the donors' cells. Attempts to make blood and marrow transplantation safer for     children with non-malignant diseases by using lower doses of radiation and chemotherapy have     largely failed because of a high rate of graft rejection.      In many such cases, it is likely that the graft is rejected because the recipient is     sensitized to proteins on donor cells, including bone marrow cells, by blood transfusions.     The formation of memory immune cells is a hallmark of sensitization, and these memory cells     are relatively insensitive to chemotherapy and radiation. Alefacept, a drug used to treat     psoriasis, on the other hand, selectively depletes these cells. The investigators are     conducting a pilot study to begin to determine whether incorporating alefacept into a low     dose conditioning regimen can effectively mitigate sensitization and, thereby, prevent     rejection of allogeneic blood and marrow transplants for multiply transfused children with     non-malignant hematological diseases.   "
150143|NCT01318850|"     Cognitive Remediation Therapy (CRT) can enhance cognitive performance in patients with     schizophrenia improving clinical outcome. However, the neurobiological mechanism underlying     cognitive improvement is not well understood. The aim of this study is to investigate     functional connectivity patterns before and after the neurocognitive rehabilitation therapy,     especially in fronto-temporal circuitry.   "
150144|NCT01318837|"     This study is to evaluate change of over active bladder symptom scores (OABSS) between,     before and after solifenacin treatment to OAB subjects.   "
150062|NCT01319838|"     Neuroblastoma is a cancer of the nervous system and accounts for 15% of cancer related deaths     in children. With the advancement of treatment therapies, the long term survival rate has     progressed to approximately 50%. The therapy used for treatment, however, is very toxic and     associated with serious long-term side effects. Treatment for neuroblastoma typically     includes chemotherapy, surgery, stem cell transplantation, radiation therapy, and     immunotherapy. At the end of this treatment, children with neuroblastoma commonly take the     drug isotretinoin for 6 months. Isotretinoin maintains the response to previous treatments     and helps turn the remaining cancer cells into normal nerve cells.      Most patients often respond to this treatment at first but are at a high-risk for the cancer     coming back. The majority of the children who relapse after treatment or develop recurrent     disease do so in the first two years following the completion of therapy and there are no     current treatments to cure those who relapse. This study will explore whether or not     extending the therapy with isotretinoin from 6 months to 24 months will help prevent the     cancer from coming back without causing severe side effects.   "
150063|NCT01319825|"     This is an open label pilot study to determine whether milnacipran can reduce headache     frequency in episodic and chronic migraine sufferers.   "
150064|NCT01319812|"     The objective of this study is to separately demonstrate the safety and efficacy of     BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of     femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal     popliteal artery (PPA), while the Astron stent will be used for the treatment of the common     or external iliac artery lesions.   "
150065|NCT01319799|"     The use of MRI have shown that the incidence of postoperative cerebral lesions due to     cerebral embolization is high (1). Nonetheless the extent of postoperative neurological     dysfunction is only a fraction of the actual amount of new postoperative changes detected on     MRI. Transcranial Doppler (TCD) has shown the occurrence of extensive microembolic signals in     intracerebral arteries during open heart procedures (2). The clinical significance of     cerebral microemboli is not clear (3-5). The use of serological markers to assess cerebral     injury after open cardiac surgery is difficult to interpret. The levels of markers seems to     be contaminated from extracerebral sources (6). In order assess the release of markers of     neuronal damage after open aortic valve surgery the investigators intend to examine the     levels of S-100B, NSE and Tau in cerebrospinal fluid (CSF) by comparing the levels     preoperative with the levels one day after surgery. Furthermore the investigators will     determine the total amount of cerebral microembolic signals during the surgical procedure by     means of TCD. The investigators will statistically test if there is any correlation between     the increase in cerebrospinal fluid levels of S-100B,NSE and Tau and the cerebral embolic     load.   "
150066|NCT01319786|"     Previous work has shown that increasing fruit and vegetable intake in patients with high     blood pressure improves cardiovascular function. Research indicates that this may be partly     owing to compounds called polyphenols, which are found in abundance in fruits and vegetables     and other foods such as wine, tea and dark chocolate. The investigators now wish to test if     consuming fruits and vegetables (including berries which are very rich in polyphenols), as     well as dark chocolate, has further benefits for cardiovascular function. A total of 110     subjects with high blood pressure will be recruited and asked to follow a low polyphenol diet     (2 portions of fruit and vegetables daily and no berries or dark chocolate) for four weeks (a     washout period). They will then be randomised to continue this diet or to consume 6 portions     of fruits and vegetables (to include 1 portion berries) and 1 portion of dark chocolate daily     for 8 weeks. The fruit, vegetables and dark chocolate will be provided free of charge and     delivered to the homes of the participants who are randomised to the high fruit and vegetable     arm of the study.      Assessment of microvascular and platelet function will be undertaken before and after     consuming this diet. Improvements in these tests of cardiovascular function have previously     been linked to reduced risks of heart disease in people with high blood pressure. This study     will provide evidence as to whether or not a polyphenol rich diet can reduce the risk of     developing heart disease.   "
150067|NCT01319773|"     This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of     cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group     phase will be followed by a paired-eye phase which will evaluate the safety and tolerability     of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic     emulsion (RESTASIS®) in patients with dry eye.   "
150068|NCT01319760|"     A prospective, randomized, controlled multi-site feasibility trial to assess the potential     role of the IMPELLA® 2.5 System in reducing infarct size in patients with ST-elevation     myocardial infarction (STEMI)   "
150069|NCT01319747|"     Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) and     surgically video assisted thorascopic pulmonary vein isolation (VATS-PVI) are acceptable or     even superior alternatives to antiarrhythmic drug therapy in patients with symptomatically     paroxysmal atrial fibrillation (AF). However, data comparing effectiveness in both     interventions are limited.      The investigators want to compare the effectiveness of PVI and VATS-PVI. Secondary objectives     are to compare the duration of hospitalization, quality of Life, cost and to compare the     satisfaction of the patients.   "
150070|NCT01319734|"     Null hypothesis:      No significant effect of vitamin C 500 mg Supplementation on the severity of micro-vascular     complications of type 2 Diabetes Mellitus (DM).      Alternative hypothesis:      There is a significant effect of vitamin C 500mg supplementation on the severity of the     micro-vascular complications of type 2DM.   "
150071|NCT01319721|"     To compare the outcomes of limbal conjunctival autograft (LCAG) versus amniotic membrane     graft (AMG) when combined with intraoperative 0.02% mitomycin C (MMC) after pterygium removal     in patients with recurrent pterygium.   "
150072|NCT01319708|"     The investigators will examine the balance between IVF success in terms of outcome     parameters, using a mild ovarian stimulation protocol, opposing it to the conventional     stimulation regimens in poor responders undergoing IVF.   "
150073|NCT01319695|"     The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as     compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation     protocols in women undergoing in vitro fertilisation.   "
150145|NCT01318824|"     To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory     failure.   "
150076|NCT01319656|"     The aim of PR1MaC is to establish a clinical intervention that will adapt and permanently     integrate rehabilitation services into primary care settings, which would be the reference     point in the health care system for people with Chronic diseases (CD). More specifically, the     intervention will aim to: (1) clinically operationalize the mechanisms and tools necessary     for delivery of integrated CD services, promoting continuity of care in response to the needs     expressed by stakeholders; (2) implement and deploy rehabilitation services adapted to the     realities of various clinical primary care settings and develop tools to ensure the     sustainability of interventions beyond the rehabilitation period; and (3) support clinical     primary care teams in the acquisition and maintenance of evidence-based practices for the     targeted CDs.   "
150077|NCT01319643|"     Oxygen administration is a common practice in intensive care units, although concern is     growing about oxygen toxicity. The aim of the study is to access whether a rigorous     maintenance of a state of normal oxygenation in critically ill patients could obtain better     outcomes, such as mortality, infections and organ failures, in comparison to conventional     oxygen therapy practice.   "
150078|NCT01319630|"     Major microvascular blood flow alterations have been documented in patients with severe     sepsis. It was also demonstrated that the microcirculation improved in survivors of septic     shock but failed to do so in patients dying from acute circulatory failure or with multiple     organ failure after shock resolution. Early, effective fluid resuscitation is a key component     in the management of patients with severe sepsis and septic shock with the goal of improving     tissue perfusion. The best fluid in this early resuscitation phase has been and still is     under debate. The aim of this study is to evaluate the effect of Three different     Fluids(Albumin 5%, Normal Saline, HES 130 kD) on microcirculation in severe sepsis/septic     shock patients using Sidestream Dark Field (SDF) Microscopy and Near-Infrared Spectroscopy     (NIRS) analysis.   "
150079|NCT01319617|"     The purpose of this investigation is to study the safety and tolerability of SENSIMED     Triggerfish, a soft contact lens-based device intended to continuously record relative     changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and     glaucoma suspects. All subjects receive two 24-hour recording sessions with the device in an     ambulatory setting and at weekly interval. The level of discomfort in the study eye after 24     hours and side effects are the main endpoints of the investigation.   "
150080|NCT01319604|"     The purpose of the investigation is to investigate the relationship between the study device     output and tonometric assessments.   "
150081|NCT01319591|"     The purpose of this study is to compare different estimates of calculating creatinine     clearance by mathematical formula and compare them to creatinine clearance based on a timed     urine collection in patients who received high-dose methotrexate for the treatment of primary     CNS lymphoma or CNS involvement of systemic lymphoma.   "
150082|NCT01319578|"     The specific purpose of this study is to describe the characteristics of the K2CG chewing     gum, specifically as it relates to duration of gum chewing (exposure), timing of gum chewing     in relation to a meal, and dose of K2CG chewing gum.   "
150083|NCT01319565|"     Background:      - An experimental treatment for metastatic melanoma involves cell therapy, in which     researchers take white blood cells (lymphocytes) from the tumor tissue, grow them in the     laboratory in large numbers, and then use the cells to attack the tumor tissue. Before     receiving the cells, chemotherapy is needed to temporarily suppress the immune system to     improve the chances that the tumor-fighting cells will be able to survive in the body. In     some studies of cell therapy, individuals who have received total body irradiation (TBI) in     addition to the chemotherapy (in order to increase the length of time that they do not     produce white blood cells) seem to have a slightly better response to the treatment, but it     is not known if adding radiation to the cell therapy will cause a better response for all     individuals. Researchers are interested in comparing cell therapy given with the usual     chemotherapy to cell therapy given with the usual chemotherapy and TBI.      Objectives:      - To compare the effectiveness of cell therapy given with chemotherapy to cell therapy given     with chemotherapy and total body irradiation in individuals with metastatic melanoma.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma.      Design:        -  Participants will be screened with a physical examination, medical history, blood tests,          and tumor imaging studies.        -  Participants will be divided into two groups: cell therapy with chemotherapy alone          (group 1) or cell therapy with chemotherapy plus TBI (group 2).        -  All participants will provide a tumor sample from either surgery or a tumor biopsy for          white blood cell collection.        -  Participants will have leukapheresis to collect additional white blood cells for cell          growth and future testing, and TBI group participants will also provide stem cells to          help them recover after radiation. (TBI participants who cannot provide enough stem          cells will be moved to the non-radiation treatment group.)        -  Participants will have chemotherapy with cyclophosphamide (two treatments over 2 days)          and fludarabine (five treatments over 5 days) starting 7 days before the cell therapy.          Participants in the TBI group will also have TBI for the 3 days immediately before the          cell therapy.        -  All participants will receive the white blood cells, followed by high-dose aldesleukin          every 8 hours for up to 5 days after the cell infusion to help keep the therapy cells          alive and active. Participants will also have injections of filgrastim to stimulate          blood cell production, and participants in the TBI group will also receive their stem          cells.        -  Participants will take an antibiotic for at least 6 months after treatment to prevent          pneumonia, and will be asked to return for regular monitoring and followup visits for at          least 5 years to evaluate the tumor s response to treatment....   "
150084|NCT01319552|"     Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to     transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies suggest     that certain patients transfused with blood stored for longer duration have poorer outcomes     than patients transfused fresher blood. The investigators' hypothesis is that the delivery of     an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood     leads to changes that explain the differences in outcome between patients transfused old     versus fresh blood. The investigators propose to test this hypothesis in humans by     transfusing an individual's own blood, both fresh and after storage, and comparing levels of     various outcome measures.   "
150085|NCT01319539|"     This phase II trial is studies how well Akt inhibitor MK2206 works in treating patients with     stage I-III breast cancer that can be removed by surgery. Akt inhibitor MK2206 may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
151753|NCT01297426|"     Obesity does not respond to high circulating levels of the hormone leptin. This study is     aiming at finding out why this happens and open new avenues for treatment of obesity.   "
150087|NCT01319513|"     Protein ingestion increases the rate at which the body builds new proteins in skeletal muscle     (muscle protein synthesis. This study is designed to examine how the pattern of feeding     affects muscle protein synthesis following resistance exercise. There is reason to believe     that the large rapid increase in blood amino acid concentrations that accompanies the     ingestion of a bolus of protein is important to increasing muscle protein synthesis. Thus, we     hypothesize that the consumption a bolus of protein will elevate muscle protein synthesis to     a greater extent than the consumption of an equivalent amount of protein that is consumed in     small divided doses.   "
150088|NCT01319500|"     This study investigates the drug utilization pattern of Oral Contraceptives (OC) in Croatia.     Gynecologists and Dermatologists were asked to contribute OC prescribing data to this study.   "
150090|NCT01319474|"     This study seeks to determine the rate of thromboembolic complications (blood clots),     including death attributed to thromboembolic disease, when anticoagulation (blood thinner)     therapy is withheld from pregnant patients suspected of deep vein thrombosis (DVT) after a     whole-leg compression ultrasound shows no DVT. Patients are followed for three months after     the ultrasound to determine if a blood clot is diagnosed during that time.   "
150091|NCT01319461|"     Evaluate the efficacy and safety of Hyalgan, at a dose of 20mg/2ml administered as 5     intraarticular injections at weekly intervals, for the sustained relief of pain and     amelioration of joint dysfunction in patients of OA of the knee.   "
150092|NCT01319448|"     Malaria prophylaxis is recommended for sickle cell disease patients. In Nigeria, daily     proguanil or weekly pyrimethamine are the most commonly prescribed regimens, but the current     policy is not effective due to poor compliance and drug resistance. Intermittent treatment     with a long acting drug regimen administered under supervision at clinic visits may be more     effective. The aim of this trial is to compare the tolerability and acceptability of     supervised bimonthly treatment with either sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ)     or mefloquine plus artesunate (MQ+AS), with the daily proguanil. Two hundred and seventy     patients with sickle cell disease attending the paediatric sickle cell disease clinic in     Ilorin hospital who meet the eligibility criteria and have parental consent, will be     randomized to one of three prophylactic regimens: daily proguanil, bimonthly     sulfadoxine-pyrimethamine plus amodiaquine, or bimonthly mefloquine plus artesunate. Patients     will be asked to return to clinic every two months and whenever they are sick. At enrollment,     the study paediatrician will conduct a physical examination of the child, and collect a     venous blood sample for a complete blood cell count and biochemical screen, determination of     G6PD genotype, preparation of blood smears for malaria microscopy and a blood spot for     determination of molecular markers of resistance. Four days after each clinic visit, patients     will be interviewed (by phone and, for a subset, at home or in the clinic) to ask about     compliance and adverse events. Participants will be followed for one year. The parents or     carer will be encouraged to bring their child to the Outpatient Department clinic if the     child becomes unwell. The primary outcome of the trial is tolerability, secondary outcomes     are adherence to the regimen, and incidence of malaria and the number of hospitalizations     over 12 months. If the bimonthly regimens are well tolerated and the preliminary data from     this study are promising, a larger multicentre trial will be required to determine efficacy.   "
150093|NCT01319435|"     Phase I, open-label study to evaluate the pharmacokinetics, tolerability and short-term     safety of ciprofloxacin in neonates with suspected (or proven) Gram Negative infection.     Objectives: To evaluate the multiple-dose pharmacokinetics of ciprofloxacin in neonates and     young infants (24 - 52 weeks postmenstrual age) with suspected or proven Gram Negative     infection.      To evaluate the tolerability and describe short-term safety of ciprofloxacin in neonates and     young infants with suspected (or proven) Gram Negative infection.      To describe the clinical outcomes of neonates treated with ciprofloxacin   "
150094|NCT01319422|"     Lenalidomide has clinical activity in myeloma. The closely related compound, Pomalidomide,     may have clinical activity in patients who have previously been treated with lenalidomide and     who no longer respond to it. The mechanism of anti-tumor effects of these drugs has been     attributed to several effects including anti-angiogenesis, immune activation, and     anti-proliferative effects. Recent studies have suggested that these agents can mediate     surprisingly rapid biologic effects on human monocytes and T cells. Our hypothesis is that     the proximate effects of these drugs will be sensitive and quantitative surrogates of     subsequent effects including activation of tumor antigen specific T cells as well as innate     immune cells. Understanding the correlation between the pharmacodynamics of these effects     with downstream activation using quantitative assays will facilitate the rational development     of pomalidomide as immune-modulatory drug in diverse settings as well as its optimal     development in myeloma therapy.   "
150095|NCT01319409|"     The purpose of this double-blind, randomized clinical trial to compare outcomes of     single-bundle (SB) to anatomic double-bundle (DB) ACL reconstruction. We hypothesize that     anatomically reconstructing both bundles of the ACL will lead to better restoration of     healthy knee mechanics and clinical outcomes. In addition to standard clinical outcome     measures, we will utilize a unique combination of high-speed biplane radiography (for highly     accurate assessment of knee kinematics) and 3D imaging (MRI and CT, to define joint and     cartilage morphology) to characterize joint kinematics and cartilage surface interactions     during functional tasks.      The specific aims of this study are to:      Specific Aim 1: Determine if anatomic double-bundle ACL reconstruction restores normal     dynamic knee function better than single-bundle ACL reconstruction.      Hypothesis 1.1 Knee kinematics after anatomic double-bundle ACL reconstruction are more     similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as     measured with dynamic stereoradiography 6 and 24 months after surgery.      Hypothesis 1.2 Graft elongation from 6 to 24 months after surgery is reduced with anatomic     double-bundle ACL reconstruction in comparison to single-bundle ACL reconstruction, as     measured with dynamic stereoradiography.      Specific Aim 2: Determine if anatomic double-bundle ACL reconstruction results in better     clinical outcomes than single-bundle ACL reconstruction.      Hypothesis 2.1 Anatomic double-bundle ACL reconstruction will result in more symmetrical     laxity and better range of motion and hop test scores in comparison to single-bundle ACL     reconstruction.      Hypothesis 2.2 In comparison to single-bundle ACL reconstruction, anatomic double-bundle ACL     reconstruction will result in better patient-oriented outcomes, indicating fewer symptoms, a     higher level of activity and more complete return to sport.      Successful completion of these aims will provide quantitative evidence of the efficacy of     anatomic double-bundle ACL reconstruction for restoring normal knee mechanics. Should the     results show a clear benefit for this procedure, it would provide support for wider     adaptation of anatomic DB reconstruction. By completing the proposed aims, we will also     establish a sound basis for additional studies with longer follow-up (including the subjects     in this cohort), to assess the benefits of anatomic DB ACL reconstruction for improving     long-term clinical outcomes and maintaining joint and cartilage health.   "
150096|NCT01319396|"     The purpose of this study is to compare the accuracy of the BiancaMed BM07 breathing     frequency indicator device with the respiration rate measured by a SomnoScreen RC Easy device     on 20+ human volunteers. This is being carried out in support of a 510(k) submission.   "
150097|NCT01319383|"     The purpose of this study is to compare HIV RNA expression and infection within resting     (CD4)+ cells in HIV-infected patients on stable ART before and after a single exposure to     Vorinostat (VOR), after exposure to short intervals of VOR, and after repeated short interval     exposure to VOR dosed over several weeks.      Hypotheses:        1. The frequency of resting CD4+ T cell- associated HIV RNA (RCVL) will be increased          following single and repeated exposure to VOR when given at appropriate intervals, and        2. That repeated exposure to VOR will reduce the frequency of HIV infection within resting          CD4+ T cells (RCI)   "
150098|NCT01319370|"     The current study aims to show efficacy of twice daily application of 5% Minoxidil Topical     Foam (MTF) formulation compared to placebo in the temple region of male patients with     androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and     safety of 5% MTF in male subjects with AGA in temple and vertex region, over a period of 2     years. Objective and subjective efficacy measures will be compared to baseline. Moreover, all     patients will get the equal treatment and measurements in the vertex region to enable     comparison of the efficacy of 5% Minoxidil Topical Foam in the temples not only to baseline     but also to vertex region. Additionally safety assessments will be performed throughout the     whole study.   "
150110|NCT01319214|"     The primary objective is to investigate the potential ability of Inderal (propranolol     hydrochloride) to diminish the reconsolidation of motivationally potent drug-related cues in     cocaine dependent participants. If effective in this laboratory model, Inderal may have     clinical efficacy.   "
151214|NCT01304550|"     This is a retrospective comparison of hemoglobin measurements obtained by arterial blood gas     analysis and the Masimo Continuous Hemoglobin Monitor   "
150099|NCT01319357|"     Diabetes mellitus is a metabolic disease with a growing prevalence worldwide. Currently     available therapies for type 2 diabetes have various limitations and are associated with     increased risk of hypoglycemia, weight gain, gastrointestinal side effects or edema and heart     failure.      A new and promising class of drugs are the gliptins. Several efficacy studies demonstrated a     significant improvement of HbA1c with gliptins. In addition, gliptins improved fasting as     well as prandial glucose levels and did not induce weight gain. Due to these positive     metabolic effects in combination with a very small spectrum of side effects gliptins might     very well be part of the standard therapy for type 2 diabetes in the future.      Apart form surrogate parameters like reduction of fasting and postprandial blood glucose     levels or improvement of HbA1c, the effect of gliptins on micro- and macrovascular function     and cardiovascular outcome has not been the primary focus of current studies. Diabetes     mellitus is strongly associated with microangiopathy and macroangiopathy and is a strong     independent risk factor for cardiovascular disease and cardiovascular mortality. Endothelial     dysfunction which plays a crucial role in the atherosclerotic process is commonly observed in     patients with diabetes mellitus and already prediabetes and has - amongst other factors -     been linked to fasting and postprandial hyperglycemia. Taken into account that gliptins     reduce hyperglycemia and hyperglycemic peaks by preventing inactivation of GLP-1, which     exerted beneficial effects on the endothelium in previous studies it is of major interest     whether therapy with gliptins improves endothelial function.   "
150100|NCT01319344|"     Patients with the metabolic syndrome (MetSyn) are at increased risk for cardiovascular     mortality and morbidity.This increased cardiovascular risk is attributed to metabolic     dysregulations like impaired glucose tolerance or diabetes mellitus and dyslipidemia,     abdominal obesity and arterial hypertension, which promote oxidative stress and inflammation     with consecutive endothelial dysfunction causing an atherogenic environment.      Aldosterone promoted end organ damage is mainly found in the cardiovascular system and the     kidney. Inflammation and activation of different factors promotes fibroblast growth and     matrix production resulting in myocardial fibrosis, vascular remodelling and renal fibrosis.      MetSyn and aldosterone are cardiovascular risk factors and it is of crucial importance to     note that there is a connection between MetSyn and aldosterone. Other cross sectional studies     show a direct correlation of aldosterone levels and impaired glucose metabolism in patients     with and without the MetSyn. Taken together, aldosterone influences essential parameters of     the MetSyn. Coincidentally parameters of the MetSyn are stimulus for an increased aldosterone     synthesis, i.e. visceral adipocytes.      In large scale clinical trials - RALES, EPHESUS, 4E - inhibition of MR has proven to be     beneficial in patients with congestive heart failure and post myocardial infarction and this     result has been confirmed for diabetic patients, who are known to have an increased     cardiovascular risk.      There is only very limited data on the impact of MR inhibition on metabolic, endocrine, and     inflammatory parameters in patients with MetSyn, who have not yet suffered from     cardiovascular events.   "
150101|NCT01319331|"     The purpose of this study is to determine if the drug Alpha-1 Antitrypsin (AAT, Aralast NP)     will preserve beta-cell function and help slow the progression of type 1 diabetes.   "
150102|NCT01319318|"     This study will evaluate the degree of post-operative ocular inflammation in patients who are     undergoing a pars plana vitrectomy.   "
150103|NCT01319305|"     This is a long-term follow-up of patients that participated in the BREATHE I study.   "
150104|NCT01319292|"     Asthma is the most common chronic respiratory disease in children and has much effect on     their life and study, which leads to huge economic burden and pressure to the whole families.     Some children will develop into adult patients so that asthma can be the life-long vigorous     trouble. In recent years, the prevalence rate of children asthma is increasingly going up     worldwide. The prevalence rate in last 12 months reported in USA, United Kingdom, Australia,     New Zealand was between 12% to 30%.      Center for Asthma Prevention and Education of Capital Institute of Pediatrics investigated     the national asthma prevalence in 900 thousands children in 27 provinces and cities, which     average rate was 0.11% to 2.03% in 1990. In 2000, we investigated it again in 31 provinces(43     cities) and the average national children asthma prevalence rate was 1.97%(0.25% to 4.63%)     which was much higher than that in 1990.   "
150105|NCT01319279|"     The purpose of this study is:        1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in          subjects with moderate hepatic impairment and in subjects with normal hepatic function.        2. To assess the safety and tolerability of the hydrocodone bitartrate extended-release          tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic          function.   "
150106|NCT01319266|"     The purpose of this study is to assess the effect of varying degrees of renal impairment     (mild, moderate, severe and end stage renal disease) compared with subjects with normal renal     function on the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.   "
150107|NCT01319253|"     This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and     laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that     alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that     alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic     Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model     biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing     clinical and microbiological parameters.   "
150108|NCT01319240|"     This trial is conducted in Europe. The aim of this trial is to compare the bioavailability of     insulin degludec and liraglutide, when administered either combined or as separate     administrations.   "
150109|NCT01319227|"     This is a randomized clinical trial comparing two different uncemented femoral stems and two     different uncemented sockets using Dual-energy x-ray absorptiometry, Radiostereometry and     clinical evaluation.      Hypothesis:        1. A short uncemented stem gives less periprosthetic bone resorption in the proximal femur          than a conventional uncemented stem.        2. An uncemented acetabular component with a backside of three-dimensional Titanium porous          construct gives less periprosthetic bone resorption than a backside covered with a          conventional porous coating with Titanium-beads and a hydroxy-apatite layer.   "
150191|NCT01318135|"     To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea     (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).   "
150111|NCT01319201|"     Part I: Survey of Coronary Artery Calcification and Stenosis in Participants with Different     Glycaemic Status      Aims:      To evaluate coronary artery calcification and stenosis in community-dwelling adults with     different glycaemic status, using dual-source CT angiography (CTA)      Study Subjects and Methods:      200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR)     and 200 with type 2 diabetes were recruited from an urban community of Shanghai, who then     underwent a comprehensive examination including questionnaire, anthropometric measurements,     biochemical analysis and CTA.      Part II: Follow-up of Cardiovascular Events and Re-evaluation of Coronary Artery     Calcification and Stenosis      Aims and Methods:      To investigate the development of cardiovascular diseases in subjects recruited in part I and     re-evaluate coronary artery calcification and stenosis using CTA after 3-year follow-up      To identify the predictive value of coronary artery calcification and stenosis with future     risks of cardiovascular diseases and the possible development of coronary artery disorders     among participants with different glycaemic status   "
150112|NCT01319188|"     The investigators assume that ranibizumab might be dangerous in patients with history of     coronary artery disease or cerebrovascular events. The main objective of study is to reveal     contraindications for ranibizumab prescription in patients with history of coronary artery     disease and cerebrovascular events. Moreover, an association between management with     ranibizumab and ATE rate in healthy above 50 years old persons is a concern of great interest     as well.   "
150113|NCT01318408|"     Elderly persons with dementia are at risk for seizures, however, traditional anticonvulsants     are poorly tolerated in this population. Our goal is to examine Levetiracetam (Keppra) in     elderly dementia patients with seizures. While it has been established that Keppra controls     seizures in this age group, it is important to demonstrate that treatment with Keppra would     not affect cognitive abilities in this large population of patients . As this population is     already cognitively impaired, the best choice of anticonvulsant would be one that does not     further compromise their cognitive abilities. Keppra is an excellent anticonvulsant agent in     the elderly for a variety of reasons, including safety, favorable side effect profile, lack     of interaction with other drugs, and efficacy. Our retrospective pilot data suggests that     cognition is not negatively affected by Keppra. The current prospective study will assess the     cognitive abilities of persons with cognitive impairment at baseline and at weeks 4 and 12.     The overall objective is to determine the cognitive tolerability of Keppra for seizures in     elderly cognitively impaired patients.   "
150114|NCT01318395|"     Hypertension affects approximately one fourth of the world population and therefore     contributes substantially to the worldwide burden of cardiovascular (CV) disease and     end-organ damage.      Changes in small artery structure characterized by an increased wall-to-lumen ratio (WLR) are     characteristic feature of target organ damage in hypertension. Of clinical importance,     structural arteries of small subcutaneous arteries have been shown to be of prognostic     significance, with adverse prognosis in subjects with higher WLR. However, the assessment of     arteriolar structure from biopsies of subcutaneous tissue is invasive and impractical in     clinical practice. A new approach focuses on retinal arteriolar structural parameters by     using scanning laser Doppler flowmetry (SLDF) with automatic full-field perfusion imaging     analyses (9). This approach allows the non-invasive assessment of both the outer diameter     (OD) and inner diameter (ID) of retinal arterioles in vivo and, thus, analyses vascular     remodeling of retinal arterioles by calculating WLR = (OD - ID) / ID).      A crucial role in the efforts of prevention of end-organ damage plays the renin angiotensin     system (RAS). The increased mechanical strain on the vasculature at a higher BP can cause     injury to the endothelial wall. Activation of the RAS increases BP and stimulates a local     inflammatory response to repair the injury. Long-term or repeated response to injury leads to     endothelial dysfunction and microvascular damage, and hence end-organ damage.      Combining RAS inhibitors may provide greater end-organ protection than use of either class     alone. However, ONTARGET has failed to show superiority of the dual RAS blockade (ACE-I and     ARB) in patients at high cardiovascular risk. The combination of ARBs and direct renin     inhibitors (DRIs) emerged as the only available, valid and innovative option for blocking the     RAS at two different sites (sequential blockade). Indeed, AVOID study and ALLAY study     demonstrated that the DRI aliskiren has additional and to some extent blood pressure     independent effects on albuminuria and left ventricular hypertrophy, both signs of     subclinical organ damage in hypertension, respectively.      However, no data are available with respect to the effects of ARBs and DRIs on vascular     properties in the short and long term To close this gab we focus in this study on vascular     structural and functional changes since vascular adaptation to high blood pressure occurs in     the early phase of hypertensive disease.   "
150115|NCT01318382|"     This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios     at tracheal extubation when anesthesiologists have determined that full recovery of     neuromuscular function has occurred using standard clinical criteria for participants whose     non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase     inhibitor administered as per standard routine care.   "
150116|NCT01318369|"     The main goal of this trial is to study the efficacy of Namisol® after a single dose of     Δ9-THC in the treatment of pain resulting from chronic pancreatitis. Objective measures of     pain processing, e.g. encephalography (EEG) and quantitative sensory testing (QST), are     included to provide insight in underlying nociceptive processing.   "
150117|NCT01318356|"     The objective of this study is to assess the efficacy of two treatment strategies for fatigue     and disabilities in QFS: long term treatment with doxycycline or cognitive behavioral therapy     (CBT).   "
150118|NCT01319175|"     Strength training of the hip flexors using elastic bands can induce an effect on isometric     hip strength of at least 15 %.   "
150160|NCT01318629|"     Many patients undergoing coronary angiography are found to have no significant coronary     artery disease (CAD) despite angina equivalent symptoms and/or electrocardiographic     abnormalities suggestive of myocardial ischemia. The aim of this study is to systematically     assess patients with angina equivalent symptoms despite normal coronary angiograms and to     evaluate their symptoms according to a defined algorithm.   "
155118|NCT01253499|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     TRx0037 after multiple doses in elderly volunteers.   "
150129|NCT01319032|"     In a study conducted in our laboratory few years ago, we genotyped 22 genes in 2 athletic     groups (endurance and sprinters) and in age and gender matched nonathletic controls. Few of     these genes were found to be associated with athletic performance and area of specificity.     Since then a few more genes have been found that are related to athletic performance, and we     intend to study various genes related to 3 genetic cascade: genes associated with body fluid     balance and homeostasis, genes associated with muscle strength, and genes associated with     bioenergy. The results of this study compared with athletic level will provide deeper insight     into the genetic mechanisms involved in performance.   "
150704|NCT01311271|"     The aim of this multicentric double blind study (randomized study) is to demonstrate the     relationship between the amount of rTMS and the efficacy in the treatment of upper extremity     motor deficits of stroke patients.   "
150119|NCT01319162|"     Between 40% and 85% of women with Polycystic Ovary Syndrome (PCOS) are overweight or obese     and obesity is closely linked to the development of PCOS. Although it is well established     that obesity increases the severity of the clinical features of PCOS, data regarding the     prevalence of PCOS in obese women and the change in body weight in women with PCOS over time     are scares. In a prevalence study it was investigated whether obesity increases the risk of     PCOS in the general population and they demonstrated that the prevalence rate of PCOS in     underweight, normal-weight, overweight, and obese women were 8.2, 9.8, 9.9, and 9.0%,     respectively, similar to that observed in the general population. These results suggest that     the risk of PCOS is only minimally increased with obesity. On the other hand, in a Spanish     prevalence study among overweight and obese subjects, they demonstrated a 28.3% prevalence of     PCOS, which is markedly higher compared with the 5.5% prevalence of PCOS in lean women in     Spain.      First the investigators aim to estimate the prevalence/probability of PCOS among obese,     premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms     in Sweden. Secondly, to elucidate whether women diagnosed with PCOS respond to standard     weight reduction regime to the same extent as women without PCOS.   "
150120|NCT01319149|"     A retrospective molecular diagnostic review on wound care outcomes. The time periods include     March, April, May of 2010.The retrospective review would analyze the days of healing during     the timeframe, upon the introduction of molecular diagnostic testing   "
150121|NCT01319136|"     Objective: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt     surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize the     cerebrospinal fluid (CSF) dynamics are used. The infusion test is one of these, used for     shunt surgery selection and postoperative evaluation of shunt function. Forty-eight patients     that had a preoperative investigation because of communicating hydrocephalus at the     university hospitals in Umeå and Uppsala, Sweden, participated in the study. The purpose of     this study was to evaluate a new method, with a new infusion protocol and new analysis     methods, and compare it to the current method.   "
150122|NCT01319123|"     This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing     against wound bioburden in moderately to highly exuding venous leg ulcers.   "
150123|NCT01319110|"     Specific Aim #1: To determine if levels of CoQ10 are low post-cardiac arrest (CA). We will     perform a prospective trial with the primary endpoint of describing the prevalence of low     serum CoQ10 levels.      Specific Aim #2: To determine if CoQ10 levels in post-CA patients can be increased with the     administration of exogenous CoQ10.. We will perform a randomized control trial (RCT) of     post-CA patients with the secondary endpoint of comparing CoQ10 levels among those randomized     to CoQ10 supplementation vs placebo.   "
150124|NCT01319097|"     This is a clinical study to evaluate the effects of sorbion sachet s wound dressing on soft     tissue edema and wound bioburden in moderately to highly exuding pressure ulcers.   "
150125|NCT01319084|"     Considering the development of gastric cancer surgery using da Vinci Robotic Surgical System,     the development of educational program needs to be achieved in Korea and this institute.     Moreover, because of the large number of gastrectomy including robotic surgery for gastric     cancer treatment, the investigators can provide high quality of educational program using da     Vinci System. Therefore, the investigators wanted to create an innovative real-time training     module, which can provide an intraoperative step-by-step guide to robotic surgical     procedures. This technological project was named as Advanced Robotic Multi-display     Educational System (ARMES).   "
150126|NCT01319071|"     It is still unknown whether different genetic elements play a role in athletes' ability to     create their area of specificity.In a study conducted in our laboratory few years ago, we     genotyped 22 genes in 2 athletic groups (endurance and sprinters) and in age and gender     matched nonathletic controls. Few of these genes were found to be associated with athletic     performance and area of specificity. Since then a few more genes have been found that are     related to athletic performance, and our aim in the current study is to expand our research     to these new genes which include 3 genetic cascades: genes associated with body fluid balance     and homeostasis, genes associated with muscle strength, and genes associated with bioenergy.   "
150127|NCT01319058|"     Tonsil surgery for children suffering from obstructive sleep apnea have significant post     operative morbidity including pain and occasionally bleeding. This morbidity is partly caused     by post surgical inflammation. This inflammatory process can be quantified using various     proinflammatory cytokines.      the goal of this study is to objectively compare the inflammatory process after treatment of     obstructive sleep apnea with different surgical approaches to the enlarged tonsils.   "
150128|NCT01319045|"     Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is common in     patients with congenital heart disease. Historically these patients suffered significant     morbidity and mortality due to a lack of effective therapies. More recently, advanced     therapies which target the mechanisms underlying the development and progression of PAH have     been introduced into clinical care. Oral, intravenous, subcutaneous, and inhaled therapies     are all available for the treatment of PAH. Patients with PAH are first treated with oral     agents (including sildenafil and bosentan). However, if these agents fail to achieve the     desired effect for the patient, intravenous or inhaled therapies may be initiated.     Combination therapy with multiple agents is common in routine clinical care. However, the     most efficacious therapeutic regimen has yet to be delineated. The present study seeks to     evaluate the efficacy of one specific regimen: iloprost, an inhaled prostacyclin derivative,     used in combination with oral therapy (sildenafil and/or bosentan). Iloprost has been     approved by the FDA for use in this patient population. Adults with PAH already receiving     oral therapy will be invited to participate in this study. Iloprost will be added to their     current therapeutic regimen for a period of three months, with pre- and post-treatment     assessments. These will include a cardiopulmonary exercise test, BNP (a blood test), six     minute walking distance, and a quality of life questionnaire.   "
150161|NCT01318616|"     The purpose of this study is to investigate the effect of strength training with elastic     bands on hip strength in soccer players, the effect measured with hand-held dynamometry. The     primary outcomes are isometric and eccentric hip adduction strength. The hypothesis is that     strength training with elastic bands will result in a clinical relevant increase in hip     adduction strength.   "
169847|NCT00061490|"     This study will evaluate whether a program of weight loss and exercise can help individuals     with knee osteoarthritis (OA).   "
150130|NCT01319019|"     This study is primarily designed to assess the dose response, dose interval, efficacy and     safety of three once daily (QD) doses (100mcg, 400mcg and 800mcg) and three twice daily (BID)     doses (100mcg, 200mcg and 400mcg,) of GSK961081 administered via DISKUS™ for 28 days in     subjects with moderate/severe COPD versus placebo. Salmeterol 50mcg BID is included in the     study as an active comparator.   "
150131|NCT01319006|"     A randomized, open-label, 3-period crossover study.   "
150132|NCT01318993|"     An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice     daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous     GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157     (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment     change may be eligible to participate. The primary objective is to evaluate the safety of     GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters,     vital signs and electrocardiogram. Secondary objectives will include assessments of     effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will     include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and     Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.   "
150133|NCT01318980|"     GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that     attenuates the production of leukotrienes through the blockage of the first step in the     leukotriene pathway, 5-lipoxygenase (5-LO) activation. GSK2190915 inhibits the production of     leukotriene B4 (LTB4) and cysteinyl leukotrienes (cysLTs).      This is an open label, 4-way, 4-treatment period, non-randomised, crossover study with an     interim analysis. The GSK2190915 formulations used in this study will be: a 100mg and 200mg     milled tablet, a 100mg enteric-coated tablet, and a [14C] radiolabelled GSK2190915     intravenous solution.      This study aims to determine the pharmacokinetics and absolute bioavailability of GSK2190915     to enable optimisation of suitable formulations to be used in clinical development Fourteen     subjects will be dosed to ensure data in 10 at the end of the clinical study. Seven of the     subjects will receive an IV microtracer in addition to the other treatments.   "
150134|NCT01318967|"     Comparison of renal blood flow measurements by PAH clearance and MRI   "
150135|NCT01318954|"     This study will evaluate whether exhaled nitric oxide levels are affected by allergen     immunotherapy (allergy shots). The investigators' hypothesis is that successful allergen     immunotherapy may be accompanied by decreased exhaled nitric oxide levels.   "
150136|NCT01318941|"     This study will describe the long-term safety and effectiveness, treatment patterns,and     patient reported quality of life associated with ranibizumab treatment in routine clinical     practice for all approved indication included in the local product label.   "
150137|NCT01318928|"     The purpose of this study is to examine if the correct use of antibiotics, as well as the     application of one-day-treatment, in the therapy of periodontal diseases. The population of     treated patients (184) are divided in 4 groups; Group 1: Metronidazole + mechanical treatment     in one day, Group 2: Placebo + mechanical treatment in one day Group 3: Metronidazole +     mechanical treatment on day 1 and 21 Group 4: Placebo + mechanical treatment on day 1 and 21     End points, BOP, Plaque, PPD, CAL, RAL, Microbiology will be recorded on all sites at 3     months, 1 -, 3 -, and 5 years post-treatment   "
150138|NCT01318915|"     The purpose of this study is see if a combination of two drugs, (ATG and rituximab), given at     the time of the transplant surgery, will help reduce or eliminate the need for long term     immunosuppressive medication.   "
150139|NCT01318902|"     This study will include patients with previously treated systemic relapsed or refractory     light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the     safety profile and the maximum tolerated dose/recommended phase 2 dose of IXAZOMIB     administered orally.   "
150140|NCT01318889|"     Oral mucositis can be a significant problem for cancer patients. It is typically associated     with pain and increased risk of infection and can lead to impaired nutritional status and     inadequate hydration.it can be seen in the patient population receiving high-dose head and     neck radiation therapy (85%-100%). Topical dexpanthenol acts like a moisturizer, improving     stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness     and elasticity. The stimulation of epithelization, granulation and mitigation of itching were     the most prominent effects of formulations containing dexpanthenol. The investigators suppose     that dexpanthenol mouth wash may improve oral mucositis.   "
150141|NCT01318876|"     Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or     drifts, and its safety profile may vary. While generally considered safe, influenza vaccines     have been associated in the past with increases in cases of Guillain-Barré syndrome (1976)     and with oculorespiratory syndrome in 2001. Last year, with the vaccination against the     pH1N1, an increase of allergic-like reactions was observed.      Passive surveillance is collecting notifications of adverse events (AE) on the whole     population but the sensitivity of this system is not high and its timeliness is not     necessarily optimal. Last year, with the new pandemic Influenza vaccine the investigators     piloted a web-based active surveillance of a large number of health care workers (HCW)     vaccinated with the new adjuvanted monovalent pH1N1 influenza vaccine (Arepanrix® GSK,     Canada). Because healthcare workers (HCW) constituted a well-defined group with general good     health and received the Influenza vaccine in priority, this group of people was well suited     for monitoring the safety of the influenza vaccine. For this study, 6242 HCW were recruited     in three different sites (5183 were from Quebec). A total of 468 events (local reactions,     fever, systemic reactions, gastrointestinal and respiratory problems) were reported by 430     HCW. 80% of the HCW recruited completed at least one of the three surveys and 52% responded     to all questionnaires. During this surveillance, the investigators didn't have unexpected     findings but this active surveillance of adverse events among healthcare workers would have     been effective enough to rapidly detect adverse events occurring at a rate ≥ 1 per 200     vaccinees. For this year the investigators want to expand the surveillance to more sites and     more participants to be able to detect AE occurring at rates ≥ 1 per 500 vaccinees, and to     increase the response rate to all three surveys in participants.      The main objective of this project is to estimate in HCW vaccinated against influenza the     frequency of adverse events of sufficient severity to cause work absenteeism or medical     consultation.      This year the network will include 5 Canadian hospitals (Quebec City, Vancouver, Toronto,     Halifax, + another one ) with a total enrollment of >10 000 HCW. This should allow us to     detect AE occurring at a rate of ≥ 1 per 500 vaccinees.   "
150165|NCT01318538|"     The purpose of this Stage II randomized controlled behavioral treatment development trial was     to test the effectiveness of the Women's Recovery Group (WRG) relative to mixed-gender Group     Drug Counseling (GDC) and demonstrate the feasibility of implementing the WRG in an     open-enrollment (i.e., rolling admission) group format at two clinical sites. The Stage II     trial aims were to (1) investigate effectiveness of the WRG relative to GDC in a sample of     women heterogeneous with respect to substance use and co-occurring psychiatric disorders, and     (2) demonstrate the feasibility of implementing WRG in an open enrollment group format     characteristic of community treatment programs at two sites.   "
150146|NCT01318811|"     Heparin is commonly used for anticoagulation of the extracorporeal circuit during continuous     renal replacement therapy (CRRT) but the optimal mode of delivery has not yet been validated.     Our study will compare dilute heparin to a standard concentration of heparin. The     investigators hypothesize that heparin delivered in a dilute solution will augment coating of     the filter fibers with anticoagulants, decreasing clotting events and increasing filter life.     By improving delivery of heparin to the filter and circuit, where clotting events can disrupt     dialysis, less heparin would be required for the extra-corporeal circuit and thus less     heparin would be delivered back to the patient with blood return from the machine. By     exposing the patient to less heparin it is hypothesized that fewer bleeding events would     occur, making the dialysis treatment safer. If more of the filter's fibers remain patent and     the filter is functional for a longer period of time, the CRRT would also be more effective.   "
150147|NCT01318798|"     Post-operative acute renal failure is a severe post-operative complication and is associated     with high mortality. The enhanced prediction score, including pre-as well as intra-operative     predictors accurately predicted ARF following hepatic surgery. This prediction score allows     early identification of patients at high risk of ARF and may support decision-making for     protective kidney treatment.   "
150148|NCT01318785|"     Examination of therapeutical effects of different types of armsleeves in treating lymphatic     diseases after breast cancer surgery during maintenance phase        1. thesis:           - all types should be equal regarding volume reduction        2. thesis: armsleeves manufactured with microfibre yarn are expected to be             -  better in wearing comfort and             -  better in handling features.   "
150149|NCT01318772|"     The purpose of this study is to acquire the clinical data required by the United States Food     and Drug Administration (USFDA) for 510(k) submission, for approval of a new high resolution     imaging system for fluoroscopy/radiography. It is expected that the new KALARE     (DREX-KL80)high resolution imaging system will meet the design specifications. A minimum of     30 cases will be submitted for evaluation of claims for intended clinical applications.   "
150150|NCT01318759|"     This is a comprehensive Geriatric Assessment (CGA) currently used to evaluate elderly people     in order to be able to assess their multiple organ pathology, cognitive, functional and     social problems. This CGA is a very time consuming tool although a powerful one.      The investigators want to present a new assessment test witch is short and comprehensive tool     witch will be checked in ambulatory and in-hospital geriatric patients.   "
150151|NCT01318746|"     The potassium value is important to prevent cardiac arrhythmias and sudden cardiac death. In     patients with renal failure, the potassium value is not stable and tends to raise. Until now     there are no data available if the potassium value has a circadian rhythm and if there are     individual changes from day to day.   "
150152|NCT01318733|"     A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5%     once daily in subjects with moderate to severe facial erythema associated with rosacea.   "
150153|NCT01318720|"     Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on     techniques for the treatment of neck pain is an intervention commonly implemented in clinical     practice. Recently researchers and clinicians have implemented manual therapy techniques to     the thoracic spine (midback) to treat patients with neck pain. To date no studies have     examined the short-term combined effects of thoracic spine manual therapy and cervical spine     manual therapy in the treatment of patients with mechanical neck pain. The purpose this study     is to assess the combined effects of thoracic spine thrust manipulation with cervical spine     non-thrust manipulation in patients with neck pain.   "
150154|NCT01318707|"     The purpose of this study is to compare the standard collection of whole blood in tiger top     tubes for serum collection versus a collection method of added FVIII to whole blood samples     in the hemophilia population for routine biomarker assays to ensure reliable assay results.   "
150155|NCT01318694|"     This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy     [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment     in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)   "
150156|NCT01318681|"     This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory     functions. Our group has previously shown that patients suffering from AR symptoms perform     less well on tasks requiring sustained attention compared to non symptomatic controls. Car     driving is a typical behavior that is susceptible for changes in sustained attention and     might therefore become worse under conditions when patients suffer from AR symptoms. We will     compare the driving performance of untreated, symptomatic AR patients with the performance of     symptomatic patients that have been treated with either a systemic AR medication (a pill) or     a topical medication (nasal spray)   "
150157|NCT01318668|"     In this study the effects of a nicotine challenge on brain activity, behavior and mood will     be evaluated in two groups of healthy volunteers who have a smoking habbit: The first group     will undergo a series of treatments with NicVax, aimed at producing nicotine antibodies in     the body and preventing nicotine to enter the brain. The second group will receive a placebo     treatment. This pre-treatment (vaccination) will take place over a 18-week period. All     participants will then undergo two days of testing. On each day the subjects will perform a     number of psychomotor and memory tests after a challenge with nicotine (gum) or placebo(gum).     Also brain activity will be studied in an fMRI scanner. We expect to see an effect on brain     activation and performance only in the placebo-vaccinated group. The Nicvax vaccinated group     should show activation and performance comparable to that after challenge with placebo(gum)     as in this group nicotine should not cross the blood brain barrier and enter the brain   "
150158|NCT01318655|"     The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy     subjects.   "
150159|NCT01318642|"     This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled     trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally     advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be     randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo.     Randomization will be stratified by ECOG (0 or 1).      Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every     28 day cycle. Treatment will continue until radiographic disease progression, unacceptable     toxicity, withdrawal of consent, or start of a new anti-cancer therapy.   "
150166|NCT01318525|"     Acute liver failure is a rare but dramatic disease, often affecting young people, marked by     the sudden loss of liver function in a person without preexisting liver disease.      ALF-5755 has been shown to promote cell survival after apoptotic or oxidative stress, and     liver cell regeneration in primary cultures and in vivo. ALF-5755 may become, in this     dramatic disease with high unmet medical need, a future therapy for the treatment of patients     suffering from severe acute hepatitis (SAH) and acute liver failure (ALF) not due to     acetaminophen overdose, where liver transplantation is the sole treatment in the absence of     spontaneous recovery.      The primary objective of the study is to evaluate the efficacy of ALF-5755 versus placebo.      A minimum of 60 patients will be recruited into the study in the following two treatment     groups:        -  Group A: approximately 30 patients will receive ALF-5755        -  Group B: approximately 30 patients will receive placebo (physiological saline solution:          0.9% NaCl)      Patients will receive 10 mg (25 ml) of ALF5755 or placebo every 12 hours over 3 days in slow     intravenous infusions over 10 minutes using automatic syringes.   "
150167|NCT01318512|"     This observational, prospective, multicenter study will describe the mean dose of Mircera     (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic     kidney disease. Patients are not on dialysis and are naive to, or have received     erythropoiesis stimulating agent treatment. Data will be collected for 10 months.   "
150168|NCT01318499|"     The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic     Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and     pain in the eye after cataract extraction.   "
150169|NCT01318486|"     The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the     heparin free treatment can be performed easily (without saline flushes or blood predilution)     and is at least not inferior and maybe superior to the standard care heparin free treatment     in terms of clotting.   "
150170|NCT01318473|"     This will be a prospective, single-arm, single-center, open-label study to evaluate the use     of the ActiSight™ Needle Guidance System in patients with lung lesions smaller than 15 mm     undergoing CT-guided percutaneous chest aspiration.      Target location will be in the chest area; the procedure will be performed by a trained     physician.   "
150171|NCT01318460|"     The present pilot study aims to investigate the effectiveness of the preoperative infusion of     levosimendan in patients with impaired left ventricular function undergoing coronary artery     bypass grafting.   "
150172|NCT01318447|"     This prospective, multicenter study is intended to establish the efficacy and toxicity of     treating unresectable colorectal liver metastases with accurately administered radiation     using the CyberKnife stereotactic radiosurgery system.   "
150173|NCT01318434|"     The main research hypothesis for this study is that, among patients with Major Depressive     Disorder (MDD) who have responded inadequately to treatment with SSRIs or SNRIs, the degree     of improvement, as measured by the change from baseline of the Montgomery-Asberg Depression     Rating Scale (MADRS)will be significantly greater among patients treated with EB-1010 (at the     dose of 50 mg/day or 100 mg/day) than among those treated with placebo using the sequential     parallel comparison design. The secondary research hypothesis for this study is that, among     patients with MDD who have responded inadequately to treatment with SSRIs or SNRIs, the     degree of improvement in depressive symptoms, as assessed by the MGH Cognitive and Physical     Functioning Questionnaire (MGH CPFQ) will be significantly greater among those treated with     EB-1010 (50 mg/day or 100 mg/day) than those treated with the SSRI paroxetine.   "
150174|NCT01318421|"     The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in     patients with multiple sclerosis (MS) after participation in study MS103.   "
150175|NCT01318343|"     The purpose of this study is to evaluate the safety and efficacy of single treatment vs.     multiple treatments of CoolSculpting™ by Zeltiq™ Aesthetics for non-invasive cooling of     subcutaneous fat using the eZ App 8 large applicator on the abdomen for fat layer reduction.   "
150176|NCT01318330|"     Official Title: Five-Week, Multi-center, Phase I Clinical Trial to Evaluate Safety of     Homeo-GH after Intra Venus Administration for the Treatment of Graft versus Host Disease     Patients      Sponsor: HomeoTherapy Co.,Ltd      Study Design: Single Group, Open Label, 5 Week, Safety Study      This study is designed to evaluate the safety of ex-vivo cultured adult human clonal     mesenchymal stem cells (cMSC) derived from human bone marrow in subjects experiencing acute     or chronic graft-versus-host disease (GVHD).      Study Type: Interventional   "
150177|NCT01318317|"     This phase I/II trial studies the side effects and best dose of genetically engineered     lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant     (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma     (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in different     ways and stop cancer cells from growing. Giving rituximab together with chemotherapy before a     PBSCT stops the growth of cancer cells by stopping them from dividing or killing them. Giving     colony-stimulating factors, such as filgrastim (G-CSF), or plerixafor helps stem cells move     from the bone marrow to the blood so they can be collected and stored. More chemotherapy or     radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem     cells are then returned to the patient to replace the blood-forming cells that were destroyed     by the chemotherapy. Giving genetically engineered lymphocyte therapy after PBSCT may be an     effective treatment for NHL   "
150204|NCT01317966|"     The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11)     Combination Low-dose Rituximab prednisone are effective and safe in the management of     Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).   "
171155|NCT00077714|"     The purpose of this trial is to determine if paliperidone ER is an effective treatment for     adults with schizophrenia.   "
150189|NCT01318161|"     Colorectal cancer is one of the most common cancers in the industrialized world (12% of all     cancers). In Sweden, 6000 new cases of colorectal cancer are reported each year, and almost     half of these cases result in death. Several recently published retrospective studies show     that regional anaesthesia (RA) can reduce cancer-related mortality following surgical     treatment of colorectal, breast and prostate cancers and malignant melanoma. If these results     are true, then the choice of perioperative pain management is as beneficial, or even better,     than the current oncological therapies. This theory needs to be investigated in a     prospective, randomized and controlled trail.   "
150178|NCT01318304|"     The innate immunity of the vaginal tract provides first-line defense from abnormal     microorganisms or overgrowth of common organisms, such as Candida species or Gardnerella     vaginalis. It is unclear from the current available literature whether the rate of vaginal     infection increases or decreases in frequency during pregnancy when compared to the     non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. Vaginal     infections are important players in HIV disease, potentially increasing the risk of viral     transmission. In addition, these infections may activate inflammatory markers in the     reproductive tract and increase the risk of premature delivery or other negative pregnancy     outcomes. The vaginal innate immune system has not been well characterized in pregnant women,     or in women with HIV infection. The study of how this system changes in pregnancy and HIV     infection will provide essential knowledge for further study of vaginal mucosal protection.      The investigators study is an observational study designed to compare levels of vaginal     innate immunity markers in women based on a) pregnancy status and b) HIV infection status.     Comparisons will be made between pregnant and non- pregnant women and between HIV positive     and HIV negative women. The investigators hypothesize that there will be significant     differences in levels of innate immunity between the groups.   "
150179|NCT01318291|"     The most common reason why insured In Vitro Fertilization (IVF) patients drop out of     treatment is the distress caused by the treatment.      The objective of this study is to determine the efficacy of a combined Cognitive Coping and     Relaxation Intervention (CCRI) in reducing drop out behavior in IVF patients.   "
150180|NCT01318278|"     Low blood pressure or hypotension is a very important problem that is often seen in premature     babies, especially those with low birth weight. Severe hypotension leads to significant     problems including brain bleeds, developmental delays, kidney and liver problems, and other     issues that can affect babies for the rest of their lives. An important aspect in the     management of infants with hypotension is the decision of when to treat and with what agent.     Research is being conducted to try to find the best medication to use in these situations.     Dopamine is often used first, but it does not always prove to be effective, and it has     several concerning side effects. This study will look at vasopressin, which has fewer side     effects, as a first-line medication for low blood pressure in extremely low birth weight     infants.      Hypotheses and Specific Aims: This study will show superiority of vasopressin to dopamine in     preterm, extremely low birth weight infants who have hypotension within the first 24 hours of     life. We will specifically look at its ability to raise blood pressure values, improve     clinical symptoms seen, any adverse effects, and clinical outcomes of babies being treated.   "
150181|NCT01318265|"     The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the     pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.   "
150182|NCT01318252|"     The purpose of this study is to assess the safety and efficacy of AL-54478 0.005% compared     with Latanoprost 0.005% and AL-54478 Vehicle in patients with open-angle glaucoma or ocular     hypertension.   "
150183|NCT01318239|"     The purpose of our study is to establish the accuracy of the perfusion MRI parameters and the     availability of the VEGFR2 signaling assay using phosphospecific flow cytometry in predicting     the response of liver metastasis from colorectal cancer to treatment with antiangiogenic     agent.   "
150184|NCT01318226|"     This is a Phase 2 randomized, double-blind, placebo-controlled, multiple-dose, multicenter,     parallel-group study to evaluate the analgesic activity of ATx08-001, a novel selective     peroxisome proliferator-activated receptor modulator (SPPARM), in subjects with     moderate-to-severe postherpetic neuralgia pain. Eligible subjects will be randomized to     receive either placebo or Atx08-001. Study drug will be administered orally twice a day for 7     days. Subjects will be evaluated for neuropathic pain intensity at regular intervals over a 6     hour period on Day 1 following the first dose of study drug. They will then be discharged     from the clinic and will complete diary assessments of pain severity twice a day at home.     Subjects will be asked to return to the clinic on Day 8 to complete their last set of pain     evaluations.   "
150185|NCT01318213|"     This study will test if doctors, nurses and other people who take care of patients in     hospitals wearing gloves and gown for all contact with patients in an intensive care unit     (ICU) will:        -  Decrease the chance of patients getting an infection while in the hospital        -  Decrease the chance of patients picking up bacteria as a result of being in the hospital        -  Decrease the time a patient spends in the ICU or in the hospital        -  Increase the frequency of adverse events      The study will also look at whether making doctors, nurses and other people who take care of     patients wear gloves and gown for all contact with patients will decrease the amount of time     healthcare workers spend with patients.      This study will gather information by comparing what happens in ICUs that continue to do what     they were doing before the study with what happens in ICUs that require healthcare workers to     wear gloves and gown for all contact with patients.      This study will provide information that will help to make being in the hospital safer for     all patients.   "
150186|NCT01318200|"     To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic     body radiotherapy in the treatment of patients with locally recurrent hepatocellular     carcinoma (HCC) after TACE.   "
150187|NCT01318187|"     STUDY OBJECTIVE: This randomized, controlled trial evaluates the analgesic efficacy and     safety of intravenous single-dose paracetamol and morphine for the treatment of acute flank     pain.      METHODS: The investigators conducted a randomized, double-blind, controlled clinical trial     comparing single intravenous doses of paracetamol (1 g) and morphine (0.1 mg/kg) for patients     presenting to the emergency department (ED) with acute flank pain. Subjects with inadequate     pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg).   "
150188|NCT01318174|"     The purpose of this study is to determine the prevalence of pulmonary embolism in our     population of Chronic Obstructive Pulmonary Disease (COPD) patients admitted to hospital with     dyspnea. The patients will undergo investigation for pulmonary embolism, according to current     guidelines.   "
150205|NCT01317953|"     The purpose of this study is to determine whether green tea extract is safe for     extensive-stage small lung cancer who achieved objective tumor response after first-line     therapy.   "
150678|NCT01311622|"     The purpose of this study is to determine whether fostamatinib influences the plasma     concentration of warfarin and changes its blood thinning effect, and to investigate how safe     and tolerable it is when administered with warfarin.   "
150192|NCT01318122|"     The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and     Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who     completed a phase 2/3 Thiazolidine add on study.   "
150193|NCT01318109|"     The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD)     combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic     patients with uncontrolled blood glucose.   "
150194|NCT01318096|"     In this pilot study, the investigators would examine the safety and efficacy of integrase     inhibitor-Raltegravir in the control of HIV/HBV co-infection.   "
150195|NCT01318083|"     The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD)     combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with     uncontrolled blood glucose.   "
150196|NCT01318070|"     The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily     (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled     blood glucose.   "
150197|NCT01318057|"     Warfarin (Coumadin) is a prescribed blood thinner medication used to make the blood less     thick in people with high risk of forming blood clots. Despite the various methods to monitor     this drug, life-threatening bleeding is a common undesired effect and might result in patient     death. Patients starting warfarin therapy may require several weeks or even months to reach     the appropriate blood level of warfarin. This blind practice could place the patient at high     risk. There are several demographic and clinical factors that significantly influence how     much warfarin the patient needs to attain the desired response. Genes, which control     hereditary traits, are also important. Now, the investigators know that by using the     information encoded in patient's genes the investigators are able to individualize the     therapy. Two genes are considered to be involved in warfarin response (CYP2C9 and VKORC1).     This study proposes to ascertain what CYP2C9 and VKORC1 variants are present in     warfarin-treated Puerto Rican patients. To this purpose, a novel physiogenomic array     comprising 384 variants in 222 genes of cardio-metabolic relevance will be used so the     investigators are able to determine the structure of the Puerto Rican population in terms of     ancestral contributions and how the admixture may impact the prevalence of CYP2C9 and VKORC1     variants. Secondly, the investigators will assess the association of these variants to     clinical responses in order to develop a better method of dose estimation. The expected     result is the improvement of warfarin therapy in Puerto Ricans. The proposed study will fill     a gap in the knowledge of warfarin pharmacogenetics, providing new information on the     prevalence of CYP2C9 (metabolism) and VKORC1 (sensitivity) polymorphisms in Puerto Ricans as     well as their role in the warfarin response variability observed in this admixed population.   "
150198|NCT01318044|"     Magnetic resonance imagining (MRI) in children requires sedation to achieve the degree of     cooperation or immobilization, necessary to complete these procedures successfully. In this     study the investigators analyze two most popular anesthetics used for this procedure, sodium     thiopental and propofol. The aim of this study is to determine optimal dose of propofol and     thiopental during MRI and to establish safety and efficacy of these drugs.   "
150199|NCT01318031|"     Study of a drug drug interaction between Paroxetine and PF-00299804.   "
150200|NCT01318018|"     Electroconvulsive therapy (ECT) has been shown to be an effective treatment for patients     suffering from depression, who do not respond to medical treatment. However it is often     dismissed by patients, who feel uncomfortably about the application of electric shocks to     their heads. In 2000, magnetic seizure therapy (MST) has been introduced which uses magnetism     instead of electricity to evoke convulsions. MST seems to be as effective as ECT in terms of     its antidepressant potency but may be associated with less severe cognitive side effects.      Control of anaesthesia during seizure therapy is demanding since light anesthesia might be     associated with awareness, whereas deep anesthesia impedes the antidepressant effect of the     convulsion. Therefore, Bispectral index (BIS) monitoring is frequently used to tailor     anaesthesia for ECT, however little is known about BIS following MST.      The investigators hypothesize that in comparing MST with ECT, (a) patients show a faster     increase in BIS and that (b)less left-right differences occur in BIS.   "
150201|NCT01318005|"     The purpose of this research study is to gain a better understanding of the changes that may     occur in the breast when a woman uses an oral contraceptive (birth control pill). Some     research indicates that women who use birth control pills with lower amounts of estrogen (a     hormone in the birth control pill) may have lower breast cell growth than women who use birth     control pills with a higher amount of estrogen; this research will examine that in detail.     This research will also test whether the results found in HS-07-00269 can be confirmed.   "
150202|NCT01317992|"     The purpose of this study is to determine if ibudilast is effective in reverting patients     with medication overuse headache suffering chronic daily headache back to their original     episodic headache pattern.   "
150203|NCT01317979|"     Type 2 Diabetes Mellitus (T2DM) is a serious health problem that has increased dramatically     worldwide due to the high and increasing prevalence of obesity. Medical management of T2DM is     of limited success. Because not well controlled T2DM patients are in high risk of blindness,     cardiovascular accident and end staged disease, T2DM has become a major health burden for     society. Recent data on the relative effectiveness of gastrointestinal metabolic surgery     played as bariatric surgery in the remission of T2DM, suggests that it may be significantly     more effective than current medical treatment. In considering that less than half of the T2DM     patients can achieve satisfactory treatment goal under current medical treatment,     gastrointestinal metabolic surgery shall play an important role in T2DM treatment in the     future. However, the indication for metabolic surgery and clinical predictors of success are     not clear now. These clinical predictors can help us to choose appropriate not-well     controlled T2DM patients to receive metabolic surgery and reduce dverse health outcomes in     those patients.   "
150206|NCT01317940|"     Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone     density by the end of treatment. This can lead to long-term suffering in survivors due to     poor bone health. Vitamin D is known to be associated with bone health and previous research     has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens     over the course of treatment. Researchers have also learned that a relationship exists     between both Vitamin D and fat tissue and ALL and fat tissue.      In adolescents being treated for ALL as well as in early survivors, this randomized study     will therefore examine the effect of Vitamin D and calcium supplementation on correcting     Vitamin D insufficiency and on improving bone density in the context of changes in body     composition and body fat. Bone density will be measured by a radiology exam called a     quantitative computed tomography (or qCT) while body composition and body fat will be     measured by a different radiology exam called a dual energy x-ray absorptiometry (or DEXA     scan). The study will also examine in depth the relationship between these three elements -     Vitamin D insufficiency, obesity, and ALL - and their impact on bone density.   "
150207|NCT01317927|"     The purpose of this study is to evaluate the plasma concentration and pharmacodynamics     effects of warfarin 5 mg, in the presence or absence of belinostat 1,000 mg/m².      Pharmacokinetic evaluation of belinostat 1,000 mg/m² and metabolites in the presence of     warfarin 5 mg.   "
150208|NCT01317914|"     Direct benefits to the participants, who are diagnosed with celiac disease may be substantial     and could include lessening or prevention of GI symptoms, correction of biochemical     abnormalities and reduction in risk for malignancies or bone disease which are most common in     untreated celiac disease. However, the precise benefit is unknown and the motivation for this     proposed study. If these individuals have a positive celiac serology test at the present time     there is a high likelihood that they may have celiac disease.   "
150209|NCT01317901|"     This was a Phase 1 multicenter study of bendamustine, rituximab and TRU-016 (BRT) in subjects     with relapsed indolent B-cell lymphoma. This was a multiple-dose escalation study to     determine the maximum-tolerated dose (MTD) of TRU-016 given in combination with rituximab and     bendamustine and to determine a safe dosing regimen for the combination in up to 12 subjects     with relapsed indolent lymphoma.      The originally planned Phase 2 portion, an open-label, randomized study to evaluate the     efficacy of BRT compared with BR, was not conducted.   "
150210|NCT01317888|"     The purpose of this access protocol is to allow patients with brain tumors who had previously     received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor     begins to grow, they develop side effects to the treatment, or their medical condition     changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV)     or develop another cancer).   "
150211|NCT01317875|"     This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib     in patients with myelofibrosis (MF). The study consists of two periods: the core study     period, comprising the dose escalation stage and the safety extension phase up to Week 24,     then the extension study period beyond Week 24 and up to 3 years, to further characterize the     safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will     enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the     maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional     patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The     primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting     platelet counts < 100 x 10 ^9/L   "
150212|NCT01317862|"     The purpose of this study is to assess the effectiveness and safety of transcervical foley     catheter as compared to prostaglandins for preinduction cervical ripening and labor induction     in term nulliparous women with unfavorable cervix.   "
150213|NCT01317849|"     The CSSPT study is a multi-center, randomized, double blinded, placebo-controlled secondary     stroke prevention trial in China to determine whether the addition of folic acid and vitamin     supplements will reduce recurrent stroke events and other combined incidence of recurrent     vascular events and vascular death.   "
150214|NCT01317836|"     Preoperative diagnosis of pancreatic cystic lesions remains a difficult problem in clinical     practice. At present, the treatment planning in pancreatic cystic neoplasms is significantly     restricted by the limited preoperative diagnosis. Ultrasonography (US), multidetector     computed tomography (MDCT) and magnetic resonance imaging (MRI) are the conventional     modalities in imaging of pancreatic cystic neoplasms, but by these methods the diagnostic     accuracy still remains compromised. Furthermore, recently encouraging results have been     obtained in pancreatic cystic neoplasms using 18F-fluoro-2-deoxyglucose positron emission     tomography (18F-FDG-PET) The aim of the current project is to evaluate the possibility to     enhance the diagnostic accuracy by using the combined 18F-FDG-PET-CT imaging in patients with     pancreatic cystic neoplasms by combining PET-CT with MRI and MDCT.   "
150215|NCT01317823|"     To compare the ultrasonographic cervical length with the Bishop score in determining the     administration of prostaglandin for preinduction cervical ripening in multiparous women at     term.   "
150216|NCT01317810|"     The purpose of this study is to track changes in overactive bladder (OAB) medical regimen     and/or OAB medication dosage requirements.   "
150217|NCT01317797|"     The purpose of this trial is primarily to investigate the safety and tolerability of repeated     subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis.     Furthermore, the amount of MT203 in the blood will be measured and it will be investigated     how the body responds to MT203 treatment and if MT203 is effective in the treatment of     rheumatoid arthritis.   "
150218|NCT01317784|"     The relevance of this research to public health is to make it possible to test for hepatitis     C and syphilis at point of care so that people will receive their results immediately instead     of requiring people to wait for at least a week to get their test results. This research will     make rapid tests for HIV available that can detect HIV infection earlier and are more     accurate than current tests available in the United States.   "
150238|NCT01317524|"     The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed     milk on postprandial metabolism in healthy overweight men   "
150239|NCT01317511|"     Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase     mitochondrial mass, and/or improve muscle tissue repair. The goal of this proposal will be to     provide further insight into the responsiveness of the muscle protein synthetic machinery to     food intake in relation to age.   "
150219|NCT01317771|"     Ten randomly selected patients that have undergone an open proximal biceps tendon tenodesis     with an EndoButton for bicipital pathology with Christopher Schmidt, MD, will be asked to     participate in the study. The study will assess the tendon healing to bone through magnetic     resonance imaging (MRI). Individuals will also be asked to fill a visual analog scale (VAS)     pain and disability of the arm shoulder and hand (DASH) assessment tools. The variables for     our objective will include age, hand dominance, gender and chronicity of symptoms prior to     surgery, and other related surgical procedures.   "
150275|NCT01317017|"     IFN-gamma is a central player in the development of psoriasis lesions, which can be involved     a variety of cellular processes in the skin. Dendritic cells are important cells in driving     inflammation in psoriasis through the induction of T cells that produce IL-17 in psoriasis.     Injecting IFN-g into the skin can increase the numbers of T cells and also inflammatory DCs     that produce cytokines involved in IL-17 production. Thus, the investigators hypothesize that     the dendritic cells present in the skin after IFN-g injection polarize IL-17-producing T     cells.   "
150220|NCT01317758|"     Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old,     inclusive, will be enrolled over a 5-month period into this multicenter, randomized,     double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study     and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted     vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular     subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given     with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will receive 2     doses separated by approximately 21 days.   "
150221|NCT01317745|"     Approximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years old,     inclusive, will be enrolled over a 5-month period into this multicenter, randomized,     double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study     and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted     vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular     subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given     with the adjuvant MF59 or diluent (N=216, up to 270). All eligible subjects will receive 2     doses separated by approximately 21 days.   "
150222|NCT01317732|"     In this study we propose 1) to develop a new multisensor monitoring system associating a     tri-axial accelerometer and a magnetometer to measure physical activity in free-living     adults, 2) to perform its calibration and assess its validity in a series of activity tasks     in comparison with the measure of energy expenditure by indirect calorimetry as the criterion     measure, and with existing physical activity monitors (cardiofrequencemetry and     accelerometers used either alone or in combination). Briefly the subjects will perform a     series of standardized activity tasks of different intensities and a 30-min free physical     activity period while wearing 6 MOTIONPOD(TM) and different commercial activity monitors.     Physical activity energy expenditure will be measured using a metabolic gas analyser.      Data of the 30 first subjects will be used to develop new algorithms to identify the     different activity tasks and to estimate the related energy expenditures. Data of the     following 30 subjects will be used to validate the MotionPOD(TM) against indirect calorimetry     and existing physical activity monitors   "
150223|NCT01317719|"     The primary goal of this study is to determine if surgical repair of the distal biceps fully     restores the supination strength of the forearm. Secondarily, the investigators want to     examine the insertion site location of the tendon and determine if it correlates with the     patients' functional outcome as determined by Disabilities of the Arm, Shoulder, and Hand     (DASH), Visual Analog Pain Scale (VAPS), and isometric supination torque testing.   "
150224|NCT01317706|"     To compare the ultrasonographic cervical length with the Bishop score in determining the     administration of prostaglandin for preinduction cervical ripening in nulliparas at term.   "
150225|NCT01317693|"     Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile     tissue. Shockwaves are created by a special generator and are focused using a specially     designed shockwave applicator apparatus. The shockwaves are delivered through the applicator     covering the corpora cavernosa of the penis. In previous studies the investigators used a     medium focused probe and in this study the investigators are evaluating results of this     therapy using a wider focus probe in the aim of improving results of treatment.   "
150226|NCT01317680|"     Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of     new blood vessels. The investigators hypothesized that LISW therapy could improve the     symptoms of patients with erectile dysfunction resulting from a problem of blood supply     (damage that can occur after radical prostatectomy in addition to neural damage or solely)     that do not respond to oral therapy (PDE-5 inhibitors).   "
150227|NCT01317667|"     This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the     safety and immunogenicity of the RVEc vaccine.      The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety     profile as determined by adverse event data and RVEc vaccine will elicit ELISA immunoglobulin     G (IgG) titers greater than or equal to 1:500 and toxin-neutralizing antibody (TNA)     anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine     recipients.   "
150228|NCT01317654|"     All patients who were alive at the end of the dexamethasone treatment trial conducted by     Oxford University CLinical Research Unit from 2001-2005 (n=340) will be eligible to     participate in this long-term follow-up study.      All eligible and consenting patients will undergo an assesment consisting of a simple     questionnaire, a clinical examination and a blood test. Data collected will focus on     survival, neurological disability and tuberculosis relapse. Data will be collected in     individual case record forms and entered into a computer database.   "
150229|NCT01317641|"     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201     in patients with castrate resistant prostate cancer.   "
150240|NCT01317498|"     The purpose of the study is to test the hypothesis that the addition of routine viral load     testing to the standard laboratory monitoring of HIV patients on first-line antiretroviral     treatment (ART) in Vietnam will result in better clinical outcomes for patients.   "
150241|NCT01317485|"     The first objective (LOLA) of this integrated trial is to determine whether laparoscopic     lavage leads to better clinical outcomes compared to sigmoidectomy in patients with     perforated diverticulitis with purulent peritonitis in terms of mortality and major     morbidity. The second objective (DIVA) is to determine whether sigmoidectomy with anastomosis     or sigmoidectomy with end-colostomy is the superior approach in patients with perforated     diverticulitis with either purulent or faecal peritonitis in terms of stoma free survival.     The study is designed as a multicenter and randomised trial.   "
150679|NCT01311609|"     This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the     physical effects of Systane Lubricant Eye Drops.   "
150276|NCT01317004|"     The purpose of this study is to evaluate the change in patient-reported treatment     satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care,     using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for     Medication (TSQM-9).   "
150289|NCT01316835|"     This study will evaluate whether the addition of sitagliptin treatment provides additional     decrease in HbA1C levels and increase in goal attainment in patients with inadequate glycemic     control on their current oral anti-glycemic therapy in real world practice.   "
150230|NCT01317628|"     Researchers have noted that active smoke exposure was possibly related to epigenetic     mechanism,and may further influence reactive immunotoxicological reaction on human beings.     Some studies have been reported that smoking reduction would decrease the prevalence of     respiratory symptoms and urinary cotinine level, but the underlying epigenetic mechanism and     the functional changes of immunotoxicological system were still unclear. We plan to examine     the causal relationship between smoking reduction and alterations in epigenetic     signatures/immunotoxicological reactions. Teenager Smoking Reduction Trial (TSRT) will be     population-based trial among teenagers. Eligible teenagers will be recruited in Taipei City     and urinary cotinine level will be used to monitor the exposure status of active smoking at     baseline, 1-month and 3-month of the intervention process. We will assess the potential     change in immunotoxicological markers, including Th1/Th2 cytokines and clinical immunological     measurements, before and after the intervention program. Furthermore, whole-genome     methylation and miRNA expression microarrays will be used to search candidate genes for     teenager smoking exposure. We plan to develop a prediction model for immunotoxicological     reaction by utilizing epigenetic signature data from microRNA expression and DNA methylation     profiles based on machine learning methodologies. We will also establish a personalized     epigenetic prediction model for allergy development and build the risk assessment platform     for immunotoxicological reaction under tobacco smoke exposure. Finally, we will examine the     causal relationship between epigenetic signatures and immunotoxicological reactions under an     independent children's cohort.   "
150231|NCT01317615|"     This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in     patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine     differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.   "
150232|NCT01317602|"     This is a multicenter, 1-year prospective, observational study of Atrial Fibrillation (AF) in     Greece, designed to provide real world data regarding the characteristics of AF patients in     Greece, as well as current clinical practices and adherence to the 2010 ESC guidelines.   "
150233|NCT01317589|"     Background of the study:      Treatment of Pain in Head-and-Neck Cancer Patients:      is methadone more effective than fentanyl?      Pain is a prevalent symptom in patients with cancer. A neuropathic component is seen in one     third of the patients. In patients with head-and-neck cancer neuropathic pain is far more     prevalent than in a general cancer population: 46-64%. Treatment of neuropathic pain is     complex and available treatment modalities achieve (partial) pain relief in only 40-60% of     patients. The N-Methyl-D-Aspartate Receptor (NMDAR) plays a central role in the mediation of     neuropathic pain. NMDAR blockers could be a new approach to treat neuropathic pain in     patients with cancer.      Methadone is a strong opioid but at the same time significant non-competitive NMDA-receptor     antagonist qualities have been described. Many small studies and case-reports describe the     successful rotation from different strong opioids to methadone. There are no studies that     selected patients with (predominantly) neuropathic pain to be treated with methadone, whereas     this group of patients is expected to profit from the NMDAR-antagonist properties of     methadone.      Objective of the study:      This randomised controlled trial (RCT) aims to investigate whether addition of a     NMDAR-antagonist to a strong opioid (methadone) is superior in the treatment of predominantly     neuropathic pain over a strong opioid alone (fentanyl) in terms of pain relief and time to     achieve significant pain relief.      Study design:      Open label randomised controlled trial      Study population:      opioid naïve patients with histological proven head-and-neck cancer and (partly) neuropathic     pain with a NRS score of ≥ 4, age =/> 18 years      Intervention Treatment with methadone or fentanyl patch      Primary study parameters/outcome of the study:      Is methadone more effective than fentanyl in the treatment of pain in patients with     head-and-neck cancer with respect to        1. significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) and        2. pain interference      Secondary study parameters/outcome of the study:      Is methadone superior to fentanyl in the treatment of pain in patients with head-and-neck     cancer with respect to        1. time to achieve significant pain relief        2. side-effect profile?   "
150234|NCT01317576|"     Due to the western lifestyle, correlated with a high calorie intake and low physical     activity, obesity is becoming a major health problem. All over the world obesity reaches     epidemic proportions. Obesity is closely linked to type 2 diabetes, a multi-factorial disease     that increases the presence of multiple health problems. Until now, exercise and dietary     intervention seem to be the single most effective interventions to treat obesity and type 2     diabetes mellitus. In obesity and type 2 diabetes, not only fat accumulation in adipose     tissue, but also fat accumulation in the peripheral tissues occurs. Fat accumulation in     peripheral tissues has been associated with insulin resistance. Exercise seems to have a     positive effect on the accumulation of fat in the peripheral tissue and on the insulin     sensitivity in type 2 diabetic patients.      In this study we want to investigate if a prolonged exercise training program can lower the     intrahepatic lipid content and can improve the metabolism of the liver in type 2 diabetic     patients and patients with non-alcoholic fatty liver disease, and to examine if this leads to     improvements in metabolic risk markers. To this end, we will include investigation of the     effect of exercise on adipose tissue (inflammatory markers and adipocyte size) and skeletal     muscle (ex vivo lipid metabolism) to incorporate the effect of exercise on liver, muscle and     adipose tissue and to clarify the crosstalk between these tissues in the pathophysiology of     type 2 diabetes.   "
150235|NCT01317563|"     This project will assess the effectiveness of antioxidant supplementation with common     vitamins A, C, E and selenium in controlling asthma symptoms among lean and obese asthmatics.     This project may improve our ability to treat asthma and our understanding of the link     between nutritional antioxidants and asthma.   "
150236|NCT01317550|"     The goal of this clinical research study is to compare armodafinil and minocycline when given     alone or in combination to learn which is better for controlling symptoms, such as the side     effects of chemoradiation, when given to treat lung cancer.   "
150237|NCT01317537|"     Project Summary:      An electronic personal health record (ePHR) could maximize patient/clinician collaboration     and consequently improve patient self-management and related health outcomes. The purpose of     the proposed project is to examine the feasibility, acceptability, and impact of an ePHR that     has been modified using a patient- and family-centered approach and incorporates the     experiences, perspectives, and insights of patients and family members actually using the     system. Comparison of patients with the ePHR intervention to a group of care as usual     patients will be performed. The investigators Specific Aims are: (1) To improve the     application of patient- and family-centered care elements in an existing ePHR, based on     feedback from a pilot study of patients and their families. The modified ePHR will be tested     in a pilot group of patients with hypertension and their families. (2) To implement and test     the effectiveness of the modified ePHR with patients being treated for hypertension by a team     of physicians, mid-level practitioners, nurse clinicians, and support staff in two ambulatory     settings. Outcome measures will include patient activation and perception of care,     quantifiable biological markers, patient-physician communication, and congruence of treatment     with guidelines, particularly medication management; (3) To monitor the shift in provider and     support staff awareness and incorporation of patient- and family-centered care as a result of     implementation of the ePHR using questionnaires and focus groups. If successful, this ePHR     could be implemented in additional locations in the Southeast.   "
150242|NCT01317472|"     Recent studies have demonstrated that patients with throat-related reflux often require twice     daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once     daily therapy offering little relief. As dexlansoprazole is a twice-daily release proton pump     inhibitor requiring only once-daily dosing, it may provide LPR symptomatic relief comparable     to that of twice daily dosing, yet be more readily approved by third party payers because of     its once daily dosing requirements. It is hypothesized that, in patients with     pharyngeal-probe proven throat reflux, there will be significantly greater improvement in     symptoms and pharyngeal probe findings in those patients receiving dexlansoprazole than those     receiving placebo alone.   "
150243|NCT01317459|"     Background: 50% of people with diabetes are living with too high blood sugars and increased     risk of diabetes related complications together with poor quality of life. The need to     improve diabetes care by better enabling patients to utilise their individual and local     resources to self-manage the condition is widely recognized, yet there is a lack of access to     evidence-based patient-centred healthcare interventions. At present the individual patient's     judgement of own concrete situation mostly remains unexplored and insufficiently used in     decision-making causing that problems perceived by the patient in living with the illness     remain unrecognised and insufficiently resolved.      Aim and Methods: Guided self-determination (GSD) is an educational method developed to     promote patient autonomy, participation, skills building and intrinsic motivation. In this     evidence-based group-intervention the main objective is to implement and evaluate GSD through     a randomised controlled trial. GSD methods will be performed seven times for the intervention     group. The control group will receive traditional out-patient consultations - 'care as usual'     Outcome measures will be performed at baseline, after 9 and 18 months. The project will focus     on adults with type 1 diabetes (18-55 yrs) where an improvement will be highly cost-effective     in preventing late complications and enhanced psychosocial health. GSD is presumably an     intervention providing psychosocial support applicable in busy clinical practice.      An alliance is established between Haukeland University Hospital, Norway and Steno Diabetes     centre, Copenhagen, Denmark, Centre of Evidence-Based Practice, Bergen University College,     and Bergen University to conduct this intervention and thus make the best possible use of     interrelated knowledge within the issue.   "
150244|NCT01317446|"     The purpose of this study is to determine whether rinsing with an amine fluoride/stannous     flouride mouthrinse in addition to daily tooth brushing is more effective than tooth brushing     alone.   "
150245|NCT01317433|"     The aim of this study is to test the role of cycline in the prevention of acne-like skin rash     in metastatic colorectal patients treated with Cetuximab and intensified FOLFIRI.   "
150246|NCT01317420|"     This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated     dose (MTD) of a new drug BI 836845 which blocks the insulin growth factor (IGF) pathway     believed to be involved in cancer growth. BI 836845 will be administered for the very first     time into cancer patients.      The study will also look at the overall safety of the drug, and examine the drug levels in     the body at specific timepoints during the trial (pharmacokinetic profile); the effect the     drug may have on tumours will also be examined (pharmacodynamics).   "
150247|NCT01317407|"     After an operation many patients are in a confused mental status at the intensive care unit.     In this status they possibly fall out of their bed or pull out endotracheal tubes or central     venous catheters accidentally. For this, they need permanently monitoring and control through     intensive care personnel.      The goal of the VIPSafe project is to develop robust techniques for automated patient     monitoring, that rely on data from a small number of untethered sensors, which are     nonetheless flexible enough to cope with a large variety of demands.   "
150248|NCT01317394|"     This study is a retrospective research in order to compare and analysis the risk factor,     clinical manifestation and efficacy of albicans candidemia by pulling medical records. We     hope that this retrospective research will let us understand the method of treatment and     prevention of albicans candidemia in order to improve the quality of healthcare.   "
150249|NCT01317381|"     ICG- Leberfunktionstest versus neue Biomarker als prognostischer Marker bei     intensivmedizischen Patienten   "
150250|NCT01317368|"     This study is conducted to evaluate different analgesic treatments effect following operation     where the prostate gland is surgically removed.      The different treatments the investigators wish to investigate is:        1. Transversus Abdominis Plane (TAP) block.           The TAP block is a rather new method, where a local anaesthetic is deposited between the          two inner abdominal muscles. Between these muscles, the nerves that innervates the          anterior part of the abdominal wall is situated.        2. Wound infiltration           In this method you deposit a local anaesthetic in the edges of the wound.        3. Placebo      No active local treatment is given.      All patients who wish to participate will be allocated to one of three different treatment     groups.      Group 1:      Will receive TAP block with a local anaesthetic and wound infiltration with saline.      Group 2:      Will receive wound infiltration with a local anaesthetic and TAP block with saline.      Group 3:      Will receive TAP block with saline and wound infiltration with saline.      Beside this local treatment all patients will be given systemic Paracetamol (tablet) and     Ibuprofen (tablet).      In addition all patients will be given a pump containing morphine. The pump is connected to a     button which the patient can activate when they experience pain. This enables the patient to     control how much morphine he needs, following the operation.      The hypothesis is that the TAP block is superior in reducing pain and thereby reducing     morphine consumption compared to wound infiltration and placebo.   "
150251|NCT01317355|"     This study will assess the occurrence of multiple symptoms in cancer patients of 5 German     university hospitals. Primary goal of the study is to assess the prevalence of multiple     symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder).   "
150260|NCT01317238|"     The currently available stock of smallpox vaccine would be insufficient in the face of an     incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are     urgently needed because previous manufacturing methods using calf lymph are no longer     acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea     has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by     infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity,     and immunogenicity of CJ-50300 in previously vaccinated healthy volunteers   "
150252|NCT01317342|"     The purpose of this study is, in a phase II randomized trial, to test a newly developed     machine perfusion technique of human liver allografts before transplantation.      Ischemia-reperfusion injury is universal in organ transplantation and leads to varying     degrees of graft dysfunction. Despite this fact, the preservation method in organ     transplantation has been left unchanged for many years and remains simple static cold     storage. Given the scarce donor supply, an increasing number of so called marginal or     extended criteria donor organs have been used for liver transplantation, grafts which were     previously rarely considered. In addition, allocation policy has changed in many countries,     and livers are currently often distributed by the severity of the recipient's disease. As a     result, transplant candidates present sicker, with higher MELD (Model for end stage liver     disease) scores, at the time of transplant,and the risk of graft dysfunction or even failure     due to reperfusion injury is high after the use of marginal livers in sick recipients.      Machine liver perfusion techniques have been significantly improved during the past decade to     decrease reperfusion injury, and a number of promising results show beneficial effects in     various animal transplant models by either normothermic or hypothermic oxygenated continuous     liver perfusion. These techniques generally require machine liver perfusion immediately after     organ procurement. However, continuous perfusion has several drawbacks, including major     logistic efforts and risk of organ damage during perfusion and transport.      Our group, therefore, focused on the practicability of machine liver perfusion. We developed     an endischemic hypothermic oxygenated perfusion (HOPE) concept through the portal vein only.     This technique can be easily applied in the operation room shortly before transplantation of     the recipient, thus after organ transport and back table preparation.      Recently, the beneficial effect of a similar approach has been confirmed in human liver     grafts by a phase I non randomized trial. These results prove feasibility and safety of an     endischemic hypothermic machine perfusion approach and warrant further randomized studies.   "
150253|NCT01317329|"     The purpose of this study is to determine the factors that are associated with improved     cardiovascular function with the use of CPAP therapy on subjects diagnosed with moderate to     severe obstructive sleep apnea.   "
150254|NCT01317316|"     Patients with work-related eye injuries (WREI) admitted to the center in the four-year period     were enrolled in this prospective study. Institutional Review Board approval was obtained     before commencement of the study. A special data recording system was developed for the     study. The study sample comprised only the casualties occurred at workplace and while working     de facto. The data were abstracted via face to face contact in the emergency department (ED).     The data sheets comprised sociodemographic and injury-related information brought together in     15-item questionnaire. Causes of occupational injuries as reported by the victims were     assigned to either of two groups: Worker-related causes and workplace-related causes.      Since workers are known to be pressured by the workplace to work in unsafe ways, an isolated     room in the ED was used for this purpose in order to prevent bias and the patients were not     accompanied by any person other than the medical personnel in charge of due medical care. The     patients were also assured that the information obtained by the survey are to be used for     research purposes only and no feedback is to be given to employers or related persons.      Patients who did not give consent for the study, fatal accidents and patients younger than 15     years of age were excluded from the analysis.   "
150255|NCT01317303|"     Neuroplasticity refers to the ability of the nerve cells to modify their structure or     function in response to injury or insult, or other environmental stimuli, with these changes     outlasting the period of exposure. Plasticity may be observed as short term or long term     changes. In humans, neuroplasticity can be readily assessed in the motor cortex, as     excitability changes are demonstrated in the degree to which peripheral muscles are     activated, seen through changes in motor-evoked potentials (MEPs). In this study, a number of     approaches to assessing neuroplasticity will be evaluated: Paired-associative stimulation     (PAS), Theta Burst Stimulation (TBS), which is a form of transcranial magnetic stimulation     (TMS) and protocols that combine these two. In addition, participants will complete a     computerised 'rotor pursuit task' designed to provide a measure of motor learning.      The investigators aim to find the most efficacious (defined by greatest number of responders     and effect size as seen in an increase in MEP amplitude) brain stimulation protocol. The     investigators will expose the same participants to four excitatory conditioning stimulation     paradigms, with each session separated by at least a week.      Our hypotheses include:      The four conditioning stimulation protocols should increase motor cortical excitability, the     investigators therefore expect there to be a significant increase in participant MEPs, with a     positive correlation in the increase ofMEP amplitude of the protocols. The investigators do     however expect that due to the principles of homeostatic metaplasticity, that the protocols     preceded by cTBS will show greater MEP change, due to the lowering of the threshold for LTP     plasticity induction. In addition, the investigators expect that an increase in the motor     learning manifest by the rotor pursuit task and for there to be a correlation in participants     between the increase in MEP amplitude and the improvement in time on target (TOT) shown in     the motor learning task (MLT).   "
150256|NCT01317290|"     The objective of this study is to investigate the accumulation of n-3 LC-PUFA (EPA, DPA and     DHA) in human lipids by oral supplementation of ALA-rich linseed oil. In addition, the     accumulation of n-3 LC-PUFA is compared between subpopulations of different age, gender and     physiological conditions (overweight, increased serum total cholesterol).   "
150257|NCT01317277|"     Methamphetamine (METH) is a debilitating and frequently abused substance that is often     comorbid with HIV infection. HIV+ persons with current METH abuse or dependence (HIV+/METH+)     have several characteristics, in addition to their substance use, that make them particularly     susceptible to nonadherence to antiretroviral treatment (ART) including elevated rates of     neurocognitive impairment, co-occurrence of psychiatric disorders, and unstable living     situations. The investigators propose an intervention development study designed to address     these potential mechanisms of nonadherence with the following Specific Aims: 1) To further     develop and refine a personalized, automated, real-time, mobile phone, text messaging     intervention (iTAB) designed to improve adherence to ART medications among HIV+/METH+     persons; 2) To evaluate the acceptability and effectiveness of a brief psychoeducation plus     text messaging intervention (iTAB) as compared to psychoeducation alone (CTRL) for the     improvement of objectively measured medication adherence among HIV+/METH+ persons; and 3) To     examine predictors of within-person trajectories of nonadherence using the longitudinal data     collected over the study. In order to realize these aims, the investigators will leverage the     infrastructure of two unique UCSD resources increasing likelihood of study success, impact,     and innovation: 1) the Translational Methamphetamine AIDS Research Center (TMARC), which is a     NIDA-funded center that focuses on the combined effects of METH and HIV infection, and 2) the     California Institute for Telecommunications and Information Technology (Calit2), which     conducts research on state-of-the-art wireless means of health promotion. Initially, the     investigators will refine the iTAB intervention to ensure that it is user-centered and     tailored to the needs of HIV+/METH+ persons via focus groups and rapid prototyping. Once     refined, the proposed iTAB intervention will use text messages that are automated, scalable,     personalized, interactive, flexible, and motivating. The investigators will assess the     acceptability and effectiveness of iTAB in improving objectively measured adherence (i.e.,     MEMS caps) over a 6-week period via a pilot RCT with 40 HIV+/METH+ assigned to the iTAB     intervention and 20 HIV+/METH+ assigned to a psychoeducational control. Predictors of     nonadherence including frequency of METH use, neuropsychological impairment, and mood will be     examined to determine whether iTAB is better able to compensate for these factors associated     with nonadherence as compared to CTRL. Further refinement to the iTAB intervention will be     made in order to pursue a large-scale R01 using our tailored intervention.   "
150258|NCT01317264|"     The aim of this study is to investigate the potential disease preventive effects of β-glucans     from oat and barley.   "
150259|NCT01317251|"     The aim is to study the effect of milk versus cheese on fecal fat excretion and blood lipids.     To do this, a randomized crossover intervention study with 3 14-day periods (control diet,     milk diet, cheese diet) will be conducted in 16 young males. Fasting blood samples will be     collected before and after each period, and fecal samples will be collected for the last 5     days in each period.   "
150261|NCT01317225|"     The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone     biweekly can reduce the incidence of preterm labor in patients with an episode of threatened     preterm labor during the current pregnancy.   "
171869|NCT00088049|"     The purpose of the protocol is to evaluate the efficacy of olanzapine compared with     Aripiprazole in patients with schizophrenia.   "
150262|NCT01317212|"     High-grade gliomas are the commonest primary malignant brain tumours in adults, affecting     approximately 5000 people per year in the UK. Standard treatment comprises a combination of     surgery, radiotherapy and chemotherapy; however this condition remains incurable and the     average survival is approximately 18 months from diagnosis. There are a number of reasons for     this. Firstly these tumours are highly invasive and involve important areas of brain making     it impossible to remove them surgically or cure them with radiotherapy. In the majority of     cases the tumour recurs within 2 to 3cm of the original site of tumour removal. Secondly, due     to the presence of a barrier between the bloodstream and the brain, when drugs designed to     kill tumour cells (chemotherapy) are given intravenously or orally, they frequently do not     reach the tumour at a sufficient dose to have a beneficial effect. As the chemotherapy dose     has to be very high for a sufficient dose to reach the tumour, drug-related side-effects are     common.      Laboratory studies demonstrate that glioma tumour cells are sensitive to a number of     different chemotherapies, including carboplatin. When given intravenously however,     carboplatin does not reach a sufficient concentration in the tumour to have a beneficial     effect. However, studies have shown that carboplatin can be infused directly into the brain     at a concentration that is highly toxic to tumour cells, but not to normal brain tissue.     Using very small tubes implanted around the tumour, the investigators are able to infuse     carboplatin reliably and repeatedly into the area where tumours typical recur. In this study,     the investigators intend to evaluate the safety of this approach and determine the optimal     dose of carboplatin to administer. It is hoped that this study will also provide evidence of     improved survival for patients with high-grade glioma.   "
150263|NCT01317199|"     This research is being done to test an investigational product called Muscadine Plus in the     treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or     brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific     antigens (PSA) level.   "
150264|NCT01317186|"     In chronic kidney disease calcium (Ca) and phosphate (P) metabolism disorders are very common     and also they are one of the leading causes of morbidity in these population. FGF23 is a     novel factor that contributes Ca-P disorders. It has been hypothesized that FGF 23 increase     is mediated by asymmetric dimethylarginine (ADMA). The aim of the study is to evaluate this     hypothesis.   "
150265|NCT01317173|"     Chronic kidney disease is a progressive disorder that has been influenced with many factors.     Most of the patients has altered Ca P metabolism and these dis orders are the contributing     factors of the disease progression. It has been recently documented that FGF23 and Klotho are     the key factors of PTH secretion Ca-P metabolism. This study aimed to evaluate the impact of     Klotho and FGF23 on the progression of stage 3-4 chronic kidney disease.   "
150266|NCT01317160|"     This prospective randomized study aims to determine whether intermittent pneumatic     compression (IPC), 75 patients, beneath functional bracing compared to treatment-as-usual in     plaster cast, 75 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote     healing of sutured acute Achilles tendon ruptures.      At two weeks post surgery, the IPC intervention will be ended and both patient groups will be     immobilized in an orthosis until follow-up at six weeks.      The endpoint of the first part of the study is VTE events. The primary outcome will be the     DVT-incidence at two weeks, assessed using screening compression duplex ultrasound (CDU) by     two ultrasonographers masked to the treatment allocation. Secondary outcome will be the     DVT-incidence at 6 weeks.      1) Deep Vein Thrombosis (DVT) detected by CDU , 2) isolated calf muscle vein thrombosis     (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic     pulmonary embolism detected by computer tomography.      The endpoint of the second part of the study is tendon healing quantified at 2 weeks by     microdialysis followed by quantification of markers for tendon repair.      The endpoint of the third part of the study is the functional outcome of the patients at one     year post-operatively using four reliable and valid scores, i.e. the Achilles tendon Total     Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and     EuroQol Group's questionnaire (EQ-5D) as well as the validated heel-rise test.   "
150267|NCT01317147|"     The morbidly obese frequently present with mood and anxiety disorders, which are often     treated with serotonin reuptake inhibitors (SRI) antidepressant drugs. The investigators     hypothesized that gastric bypass surgery would decrease the absorption of SRI. The     investigators also wished to determine whether a reduction in SRI levels would increase the     likelihood of worsening depressive symptoms.   "
150268|NCT01317134|"     The objectives of the current study are to identify and evaluate new prognostic non-invasive     and serological markers in patients with pulmonary hypertension. The focus will be on     L-arginine metabolism and to clarify its influence on endothelial function.   "
150269|NCT01317121|"     Multi-site Communication Deficits Underlying Cognitive Dysfunction in the Prodromal Phase and     First Episode of Schizophrenia   "
150270|NCT01317108|"     Chemo-N0 (1993-1998) is the first prospective randomized multicenter trial in N0 BC designed     to prospectively evaluate the clinical utility of a biomarker. It used uPA/PAI 1 as     stratification criteria and randomized high-risk patients to chemotherapy versus observation;     low-risk patients remained without any systemic therapy. The trial was designed to answer two     principle questions:        1. Can the reported prognostic impact of uPA and PAI 1 be validated in a prospective          multicenter therapy trial? Does low uPA/PAI 1 identify those low-risk N0 patients who          are candidates for being spared necessity and burden of adjuvant chemotherapy?        2. Do uPA/PAI 1 high-risk patients benefit from adjuvant CMF chemotherapy?   "
150271|NCT01317095|"     The investigators are conducting this research to compare two different methods of closure of     the sternum after cardiac surgery to determine if one method is better than the other. Open     heart surgery always requires a sternotomy, and at the end of surgery the sternum needs to be     closed. The sternum can be closed with Stainless Steel Wires or Sternalock rigid sternal     closure system with equivocal results; however, the outcomes of these two methods have never     been investigated in a randomized study. Thus, the investigators are conducting this study to     compare two different methods of closure if one method demonstrates any recovery benefit over     the other, using randomizing the subjects 1:1 to either rigid fixation with Sternalock or     stainless steel wire closure. Recover benefit will be measured by postoperative intubation     time, length of intensive care unit stay, and overall postoperative length of stay   "
150272|NCT01317082|"     The primary objective is to test the hypothesis that the use of the Pressure Right device in     combination with ondansetron and dexamethasone would result in a lower incidence of     postoperative vomiting (emesis) than the combination of antiemetic therapy alone.   "
150273|NCT01317069|"     Through clinical practice, to explore if the application of Fluorouracil implant could     effectively delay the local tumor recurrence and improvement the postoperative survival time     in patients with gallbladder cancer and bile duct cancer.   "
179726|NCT00196859|"     This trial is done to determine the role of adjuvant chemotherapy with capecitabine in     patients ≥ 65.   "
150277|NCT01316991|"     Investigators are interested in learning how appetite responds after chewing gum.      In this research study subjects will be asked to eat a lunch meal provided at our Center.     After eating the lunch meal, subjects will answer questions describing their feelings of     hunger, thirst and desire to eat every 30 minutes for 3 hours.      Blood will be drawn throughout the study period to determine how chewing gum impacts certain     hormones released from your intestine after eating and therefore how they influence your     appetite. Blood draws will be done every 30 minutes for 3 hours. At only one of the two study     visits, subjects will chew gum during specific times. One study visit will not include     chewing gum.      After three hours, there will be a snack to eat as much as desired followed by one more set     of questions and blood draw.      All study visits will take approximately 4 ½ hours.   "
150278|NCT01316978|"     This study is designed to assess bioequivalence between one test and two reference     formulations used for treatment of headaches and temporary relief of pain.   "
150279|NCT01316965|"     Postoperative delirium is common in the elderly and is associated with a significant increase     in mortality, complications, length of hospital stay and admission in long care facility.     Several interventions have proved their effectiveness to prevent it but their combination     within a multifaceted intervention needs to be assessed using rigorous methodology based on     randomized study design. CONFUCIUS trial aims to measure the impact of a multifaceted program     on the prevention of postoperative delirium in elderly.   "
150280|NCT01316952|"     A cluster of reports of hypersensitivity reactions among patients who switched from     carvedilol (immediate release formulation, referred to hereafter as carvedilol) to carvedilol     extended release was received during the initial post-launch period of carvedilol extended     release. In follow up to this observation, product labeling for both agents was updated and a     nested case control study was subsequently conducted to examine the risk of serious     hypersensitivity reactions i.e. anaphylactic reaction and/or angioedema among patients who     used carvedilol extended release compared to carvedilol and separately compared to other long     acting beta(β)-blockers. This proposed analysis is an update to the previously conducted     analysis using the same database, LabRx, now containing 2 additional years of data, which     should provide a larger number of carvedilol extended release exposed subjects.   "
150281|NCT01316939|"     A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of     two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission     over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the     Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response     (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK     sponsored induction study. The primary endpoint will be proportion of subjects in remission     at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical     laboratory parameters including liver function tests, vital signs and electrocardiogram.     Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes     assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2,     EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.   "
150282|NCT01316926|"     The study is prospective, open, randomized, crossover in steady state and the volunteers     received multiple doses of the drug test and reference (two periods of drug administration).   "
150283|NCT01316913|"     This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study     to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder,     GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when     administered once-daily over a 24-week treatment period in subjects with chronic obstructive     pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will     complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a     24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone     contact for adverse event assessment will be conducted approximately one week after the last     study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the     study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough     (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment     Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical     laboratory tests.   "
150284|NCT01316900|"     This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study     to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and     GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when     administered once-daily over a 24-week treatment period in subjects with chronic obstructive     pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will     complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a     24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone     contact for adverse event assessment will be conducted approximately one week after the last     study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the     study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough     (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment     Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical     laboratory tests.   "
150731|NCT01309945|"     The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared     with continued duloxetine in the treatment of patients with treatment resistant depression     (TRD).   "
150285|NCT01316887|"     The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse     events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue     medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects     with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated.     A placebo arm is included to evaluate these products compared to an inactive control.   "
150286|NCT01316874|"     This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with     carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus     Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple     courses of intravesical treatment.   "
150287|NCT01316861|"     The Purpose of This Study is to Evaluate the Efficacy and Safety of Acarbose in Type 2     Diabetic Patients Using Two Different Formulations of Acarbose 50mg.   "
150290|NCT01316822|"     This is a Phase 1 study during which patients with advanced cancer will receive     investigational study drug ARRY-382. Patients will receive increasing doses of study drug in     order to achieve the highest dose of the study drug possible that will not cause unacceptable     side effects. Patients will be followed to see what side effects and effectiveness the study     drug has, if any, in treating the cancer. Approximately 50 patients from the US will be     enrolled in this study.   "
150291|NCT01316809|"     Background:      - AZD8055 is an experimental cancer treatment drug that works by inhibiting a protein called     mTOR, which is known to promote tumor cell and blood vessel growth and to control tumor s     energy and nutrient levels. AZD8055 is the first drug that inhibits both types of mTOR     protein and is expected to be more effective than prior mTOR inhibitors. However, more     research is needed to determine its safety and effectiveness in treating brain tumors known     as gliomas that have not responded to standard treatments.      Objectives:      - To evaluate the safety and effectiveness of AZD8055 in individuals with gliomas that have     not responded to standard treatments.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with gliomas that have not     responded to standard chemotherapy, surgery, or radiation.      Design:        -  Participants will be screened with a physical examination, medical history, blood tests,          and tumor imaging studies.        -  Participants will be separated into two treatment groups: one group that will receive          surgery to remove the glioma and one that will not have surgical treatment.        -  Participants in the nonsurgical treatment group will take AZD8055 by mouth daily for a          42-day cycle of treatment. Participants will keep a diary to record doses and keep track          of any side effects.        -  Participants in the surgical treatment group will take AZD8055 by mouth daily for 7          days, and then will have tumor removal surgery. At least 3 weeks after surgery,          participants will resume doses of AZD8055 and will continue to take the drug for as long          as the tumor does not recur.        -  During treatment, participants will have regular visits to the clinical center,          involving frequent blood and urine tests and other examinations to monitor the effects          of treatment. Participants will have imaging studies to study the cancer's response to          the treatment.        -  Participants will continue to have cycles of treatment for as long as the treatment          continues to be effective and the side effects are not severe enough to stop          participation in the study....   "
150292|NCT01316796|"     Background:      - Chronic leg ulcers are a complication of many blood disorders such as sickle cell disease,     thalassemia, and other red blood cell disorders. In these disorders, red blood cells break     down earlier than normal, which researchers suspect may cause or contribute to the     development of leg ulcers; however, the exact cause is unknown, and current therapies are not     very effective. Researchers are interested in determining if a research cream made with     sodium nitrite, a substance that is known to increase blood flow by dilating blood vessels,     may speed up the healing of skin ulcers.      Objectives:      - To evaluate the safety and effectiveness of topical sodium nitrite cream as a treatment for     chronic leg ulcers in individuals with sickle cell disease or other red blood cell disorders.      Eligibility:      - Individuals at least 18 years of age who have sickle cell disease or another red cell     disorder and have had a leg ulcer for more than 4 weeks.      Design:        -  Participants will be screened with a physical examination, medical history, blood tests,          and an examination of the ulcer, including x-ray of the leg(s) with the ulcer and swabs          from the wound.        -  Participants will be scheduled for a 5-day inpatient stay at the Clinical Center, with          the following procedures:        -  Days 1 and 2: Participants will have blood draws, a wound assessment, ultrasound of the          affected leg, imaging studies (magnetic resonance imaging and infrared photography),          thermo-patch application to monitor temperature changes, measurements of blood flow in          the skin, and questionnaires about pain and quality of life. An optional skin biopsy may          also be conducted with samples taken near the skin ulcer        -  Day 3: Participants will have one ulcer treated with the topical cream. Frequent blood          draws will be conducted before application and then regularly for up to 6 hours after          application of the cream. Thirty minutes after the research cream is applied,          participants will have imaging studies of the treated leg and measurements of pain          levels and blood flow.        -  Day 4: Participants will have a blood draw and temperature recordings taken.        -  Day 5: Participants will have the research cream applied and the same imaging studies as          before, and will be discharged for care at home.        -  For the following 3 weeks, participants will come to the clinical center twice a week to          have the research cream applied to the leg ulcer and tests performed by the study          researchers.        -  For the fourth and final week, participants will return for additional cream treatment          sessions, imaging studies, blood draws, and other tests as directed by the study          researchers.        -  Study participation will end in the following week (week 5). Subjects will come for a          final visit one month after the end of the study.   "
150293|NCT01316783|"     Background:      - African Americans have one of the highest rates of type 2 diabetes in the United States,     and often have other medical problems related to obesity and cardiovascular disease. These     conditions have various risk factors, including high blood sugar levels, high cholesterol     levels, and insulin resistance. However, these risk factors have not been studied very     closely in individuals with African ancestry, including Afro-Caribbean and sub-Saharan Africa     migrant populations. Researchers are interested in conducting a genetic study on obesity,     adult-onset diabetes, heart disease, and other common health conditions in individuals with     African ancestry.      Objectives:      - To collect genetic and non-genetic information from individuals with African ancestry to     study common health conditions related to obesity, adult-onset diabetes, and heart disease.      Eligibility:      - Individuals at least 18 years of age who self-identify as African American, Afro-Caribbean,     or migrants from sub Saharan Africa.      Design:        -  Participants will undergo a physical examination and will provide a blood sample for          study.        -  Participants will also answer questions about personal and family medical history and          current lifestyle behaviors.        -  No treatment will be provided as part of this protocol.   "
150327|NCT01316328|"     The single shot partial breast irradiation (SSPBI) trial was designed as a prospective Phase     II single-arm study. The use of a single dose tumor bed is expected to be very effective in     terms of tumor control, but it could increase the incidence of radiation induced erythema.     Therefore, the investigators assumed that a decreased DNA repair capability, as well as a     reduced detoxification of the damage caused by oxidative stress could explain the increased     acute toxicity, i.e. a higher incidence of erythema after a single dose. For this reason the     investigators decided to investigate SNPs of genes involved in antioxidant and DNA damage     repair pathways such as GST, XRCC1, XRCC3 and RAD51.      The investigators assumed an erythema rate of 20% and 54% in patient groups at low and high     risk, respectively, (groups were identified based on the absence/presence of the above     polymorphisms alone or in combination), thus the minimum sample size was 56 patients with     α=0.05, 2-tailed test and a power of the study of 80%.   "
187632|NCT00302588|"     Investigate the final diagnosis and treatment result of metastatic cervical carcinoma of     unknown primary   "
150294|NCT01316770|"     Background:      - Sj(SqrRoot)(Delta)gren s syndrome is an autoimmune disease (where the immune system attacks     normal body tissues) that affects the salivary glands. Many people with     Sj(SqrRoot)(Delta)gren s syndrome are not able to make enough saliva because their salivary     glands are inflamed. The dry mouth that results can interfere with daily activities and can     lead to dental cavities, mouth sores, and infections. Injections of corticosteroids into the     parotid glands can improve saliva production in people with to Sj(SqrRoot)(Delta)gren s     syndrome, but current treatment practices may provide only temporary relief. Researchers are     interested in studying the effectiveness of stronger corticosteroid injections (using     dexamethasone) to determine how the corticosteroid treatment actually works.      Objectives:      - To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva     production in individuals with primary Sj(SqrRoot)(Delta)gren s syndrome.      Eligibility:      - Women between 18 and greater of age who have been diagnosed with primary     Sj(SqrRoot)(Delta)gren s syndrome, and have had a biopsy of the minor salivary glands in the     past 5 years that shows a moderate level of inflammation.      Design:        -  Participants will be screened with a full medical history and physical examination,          blood and urine tests, and salivary gland biopsies. Participants will also be screened          with tests of saliva flow production and evaluation of the salivary ducts and glands,          and will complete questionnaires about dry mouth symptoms.        -  At the first treatment visit, participants will receive an injection of dexamethasone          into one parotid gland and an injection of saline into the other gland. After the          injections, participants will provide a blood sample to test the level of dexamethasone          in the blood.        -  Two weeks after the first treatment, participants will return for an evaluation visit to          have saliva flow rate measurements taken, and will complete a questionnaire about dry          mouth symptoms.        -  Four weeks after the first treatment, participants will have a second treatment for each          parotid gland, with the same tests and questionnaires as before.        -  Participants will have additional evaluation visits 6 and 8 weeks after the first          treatment visit, with a followup telephone call approximately 6 weeks after the last          dexamethasone treatment visit.   "
151354|NCT01302730|"     This study aims to test whether a new instrument (questionnaire) is useful for identifying     patients with ankylosing spondylitis.   "
150295|NCT01316757|"     This phase II trial is studying how well giving carboplatin, paclitaxel, cetuximab, and     erlotinib hydrochloride together works in treating patients with metastatic or recurrent     squamous cell head and neck cancer. Drugs used in chemotherapy, such as carboplatin and     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them.     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving combination chemotherapy together with cetuximab and erlotinib     hydrochloride may kill more tumor cells.   "
150296|NCT01316744|"     RATIONALE: Ketamine hydrochloride may lessen neuropathic pain in patients with cancer. It is     not yet known whether ketamine hydrochloride given together with the best pain management is     more effective than a placebo given together with the best pain management in treating     neuropathic pain in patients with cancer.      PURPOSE: This randomized phase III trial is studying ketamine hydrochloride given together     with the best pain management to see how well it works compared with giving a placebo     together with the best pain management in treating cancer patients with neuropathic pain.   "
150297|NCT01316731|"     Rationale: Proteins released from muscle during and shortly after exercise, often referred to     as myokines, may be central to our understanding of the cross-talk during and after exercise     between skeletal muscles and other organs, in particular the liver. So far only a few     myokines are identified (e.g. IL-6, IL-8, IL-15, TNF-alpha). Taking into account the role of     these several known myokines in developing insulin resistance, revealing new putative     myokines might provide valuable information and a direction for future research on the     pathogenesis and treatment of type 2 diabetes mellitus.      Objective: The objective of the present study is to identify novel myokines, expression of     which is altered in skeletal muscle after a single bout of exercise.      Study design: experimental study. Study population: Ten healthy, male subjects between 40 and     60 years of age and BMI < 30 kg/m2, will participate in this study.      Intervention: A single exercise bout that consists of one hour one-legged cycling on a     adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as     control for the exercising leg.      Main study outcomes: Main study outcomes include upregulation of genes in skeletal muscle     after exercise (with a focus on genes encoding myokines) and changes of blood plasma levels     of selected proteins after exercise.   "
150298|NCT01316718|"     The purpose of the trial is to define the clinical benefit and possible mediators of the     benefit of mesalazine in Irritable Bowel Syndrome (IBS) with diarrhoea.      The investigators will therefore evaluate symptoms (primarily bowel frequency) and markers     reflecting mast cell activation and small bowel tone.   "
150299|NCT01316705|"     This study aims to determine if early embryonic development, in D2 and D3 and the blastocyst,     is compromised by the fine morphology of sperm nucleus. This will draw the IMSI, in which     sperm will be chosen using the classification MSOME and ICSI in which sperm morphology is     elected with less magnification. Both techniques are performed in oocytes of donor , being     the coohorte used for both techniques picked at random. All courses will begin as a crop     sequence, using the criteria of the IVF laboratory. Transfers will be made in blastocyst     stage (D5 or D6), except in cases where the number of fertilized is less than 6 or fewer than     6 embryos of acceptable quality in D3, which would transfer the same D3 . With donor oocytes,     the quality of these need not be compromised and to perform the same technique in all oocytes     results in pure transfers with both techniques. It allows us to compare results in term of     pregnancy, implantation and early abortion rate, as well as embryo quality.   "
150300|NCT01316692|"     RATIONALE: Aurora A kinase inhibitor MLN8237 may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.      PURPOSE: This phase II trial is studying how well Aurora A kinase inhibitor MLN8237 works in     treating patients with unresectable stage III-IV melanoma      Funding Source - FDA OOPD   "
150301|NCT01316679|"     Specific urine proteases or groups of these enzymes can be reliable biomarkers and an     effective gauge of response to therapy in patients with hepatocellular carcinoma.   "
150302|NCT01316666|"     The autonomic or automatic nervous system helps control blood pressure. Diseases of the     autonomic nervous system may result in a drop in blood pressure on standing in many cases     leading to fainting. Diseases that affect the autonomic nervous system include pure autonomic     failure, multiple system atrophy and Parkinson's disease, and can present with very similar     symptoms and it is sometimes difficult to determine an exact diagnosis. The purpose of the     study is to find out if the blood pressure response from taking a single dose of the     medication atomoxetine can help in the diagnosis of these diseases.   "
150303|NCT01316653|"     The purpose of this study is to conduct a randomized controlled trial that examines how a     family based, community centered intervention effects early childhood BMI trajectories.   "
150328|NCT01316315|"     The purpose of this study is to determine whether a single IV dose of N6022 will have a     significant bronchoprotective effect, compared with placebo, during methacholine challenge.   "
150332|NCT01316263|"     The purpose of this study is to evaluate the tumor response of stable disease (SD), partial     response (PR), or complete response (CR) [according to Response Evaluation Criteria In Solid     Tumors version 1.1 (RECIST v1.1 criteria)] at 12 weeks in participants with Gastrointestinal     Stromal Tumors (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRα)     mutations and patients with GIST not harboring PDGFRα mutations.   "
150333|NCT01316250|"     The results of the International Randomized Study of Interferon and STI571 (IRIS) trial     indicate that in patients with chronic phase CML treated with first line imatinib,     achievement of a complete or partial cytogenetic response (CCyR or PCyR) at 12 months is     associated with a significantly better progression-free survival (PFS).      Second generation tyrosine kinase inhibitors such as nilotinib can overcome imatinib     resistance because of greater potency to bind to BCR-ABL. Recent results indicate that, in     patients with previously untreated chronic phase CML, nilotinib results in a faster and     higher rate of CCyR or PCyR than imatinib. However, nilotinib use is associated with diet     restriction and much higher financial cost.      The primary objective of this study is to evaluate the ability of imatinib to maintain a     complete cytogenetic response (CcyR) in patients who achieved a CCyR after 12 months of     first-line treatment with nilotinib.   "
150304|NCT01316627|"     Body Dysmorphic Disorder (BDD) is a disabling condition that until recently has been largely     ignored. Sufferers of BDD worry excessively and unreasonably about some flaw in their     appearance that may be minimal or even nonexistent. These internalized body image distortions     prompt sufferers to constantly check the perceived defects in mirrors, seek reassurance of     their images from others, obtain unnecessary cosmetic and/or dermatological procedures, and     even conduct self-surgeries. These obsessive concerns and compulsive behaviors cause     significant emotional distress and often significantly interfere with global functioning.     Currently, cognitive-behavioral therapy (CBT) in conjunction with psychopharmacology is the     preferred treatment for BDD. In addition, two relatively new exposure techniques (mirror     retraining method and crooked mirror externalization therapy) that utilize mirrors to     exaggerate the patient's imagined defect appear to increase the benefits of CBT. However, the     treatment efficacies of these relatively novel methods have not been rigorously tested or     methodologically compared. Although six out of seven patients treated with crooked mirror     externalization therapy at the Westwood Institute for Anxiety Disorders, Inc. demonstrated     significant gains, the small sample size does not allow for any significant generalizations.     Thus, the goals of this project are: 1) to determine the efficacy of exposure therapy that     utilizes mirrors in the treatment of BDD, and 2) to evaluate the level of effectiveness of     the mirror retraining method versus the crooked mirror externalization therapy. To accomplish     these goals, each subject taking part in the study will do the following. They will go     through an in-depth interview with the study physician, Dr. Kagan, and complete several     clinical assessment questionnaires to confirm that they have BDD according to the Diagnostic     and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV). They will be assessed     by the study independent evaluator and complete several paper-and-pencil tests to determine     the severity of the BDD and if they have any cognitive difficulties. The subject will     participate in 3 weeks of CBT with either the mirror retraining method or the crooked mirror     externalization therapy. After the CBT, we will repeat the clinical assessment questionnaires     and neurocognitive testing. From the difference between the before and after scores on all     these tests, we will determine if there has been any change in the subject's BDD symptoms,     and if so, the level of effectiveness between the mirror retraining method and the crooked     mirror externalization therapy.   "
150305|NCT01316614|"     The purpose of this study is to determine that there is no difference in final diagnosis of     FNA specimens without a stylet, compared to using a stylet, when examined by a skilled     cytopathologist.   "
150306|NCT01316601|"     Test safety and efficacy and of a novel IL-13 AB in the treatment of perianal fistulas        -  Trial with medicinal product   "
150307|NCT01316588|"     The purpose of this study is to measure the time to recolonization intraoperatively after     preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of     differential bacterial growth with or without plastic adhesive drape on the chest as well as     with or without microbial sealant on the leg.   "
150308|NCT01316575|"     The purpose of this study is to determine whether prophylactic nasal continuous positive     airway pressure (nCPAP) in the post-anaesthesia care unit (PACU) improves post-operative     pulmonary function following elective bowel surgery. The investigators hypothesize that one     hour of nCPAP in the PACU will result in a higher partial pressure of arterial oxygen (PaO2)     when compared to the standard treatment of low flow oxygen applied by face mask.   "
150309|NCT01316562|"     The purpose of this study is to determine the predictive value of standardized cognitive     tests performed in health examination centres for the diagnosis of Alzheimer's disease and     related disorders among adults aged 65 years and older with a subjective memory complaint.   "
150310|NCT01316549|"     Fludarabine is a chemotherapy drug used extensively in bone marrow transplantation. The goal     of this study is to determine what causes some children to have different drug concentrations     of fludarabine in their bodies and if drug levels are related to whether or not a child     experiences severe side-effects during their bone marrow transplant. The hypothesis is that     clinical and genetic factors cause changes in fludarabine drug levels in pediatric bone     marrow transplant patients and that high levels may cause severe side-effects.   "
150311|NCT01316536|"     The study is designed to analyze the use of music therapy to decrease pain and agitation in     intubated ICU patients.   "
150312|NCT01316523|"     Lenalidomide has been shown to have single agent activity in indolent Non-Hodgkin's Lymphoma.     It is approved for the treatment of multiple myeloma and myelodysplastic syndrome.      Rituximab is effective as a single agent and in combination with chemotherapy for indolent     Non-Hodgkin's Lymphoma.      The purpose of this study is to see how well giving lenalidomide together with rituximab     works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma.      Lenalidomide will taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until     the disease progresses, unacceptable side effects or after twelve cycles if the patient is     responding well.      Rituximab 375 mg/m2/wk x 4 weeks will begin on Day 15 of cycle 1. After 4 cycles of therapy,     if patients respond well to treatment, patients will receive a second course of Rituximab.      Blood samples will be collected to assess how the immune system is functioning.   "
150313|NCT01316510|"     Infants born with gastroschisis usually require surgery shortly after birth. After surgery     the intestine is often unable to digest human milk or formula for weeks or months. During     this time the baby has to remain in the hospital to receive special nutrition through an IV.     How bacteria colonize the intestine in these babies is unknown. Probiotics are bacteria that     appear to have beneficial effects on digestion. This study will test whether giving probiotic     bacteria to babies after surgery for gastroschisis will change the bacteria in the intestine     to be more like those of a healthy breast-fed baby.   "
150314|NCT01316497|"     The purpose of this study was to investigate if repeated inflation of a blood pressure cuff     applied around one leg causing mild ischemia (remote ischemic preconditioning) could     protect children operated for congenital heart disease from developing acute kidney injury.   "
150315|NCT01316484|"     The primary objective of the study is to evaluate how patients with gastroparesis interpret     the instructions, item content, and response options of a daily diary questionnaire designed     to assess the key symptoms of gastroparesis.   "
150316|NCT01316471|"     The purpose of this study is to evaluate the efficacy of a web-based (i.e., internet)     behavioral program to reduce pain and improve functioning in children and adolescents with     chronic pain. We hypothesize that children and adolescents in families that receive the     web-based behavioral program will report reduced pain levels and improved daily functioning     compared to children and their parents who receive online patient education.   "
150317|NCT01316458|"     To investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with     rising PSA following radical prostatectomy, to produce a sustained biochemical response     during the first 6 months of treatment.   "
150329|NCT01316302|"     This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the     symptoms of Generalized Social Anxiety Disorder (SAD).   "
150751|NCT01310881|"     This is a subject single blinded, randomized, placebo-controlled, single dose,     first-time-in-human study with three or more ascending cohorts.   "
150318|NCT01316445|"     Approximately 3 million individuals suffer from epilepsy in America alone and about 200,000     new cases of epilepsy in America are diagnosed each year (Epilepsy Foundation, 2005).     Epilepsy can be defined as a condition in which a person has recurrent, unprovoked seizures.     Prolonged or back-to-back repetitive seizures, known as acute repetitive seizures (ARS),     are medical emergencies. ARS can occur unexpectedly, a circumstance for which quick and     efficient antiepileptic drugs are needed for household and prehospital use. Currently,     benzodiazepines are the antiepileptic drug of choice when dealing with ARS because they are     proven to be efficient and take little time to work. Benzodiazepines can be administered by     mouth, by vein via a needle (intravenously; IV), rectally, between the cheek and gum     (buccally), or in the nose (intranasally; IN). The nasal formulation is not yet FDA-approved.     The rectal treatment route has been commonly used for acute seizure treatment in past years,     but recent studies propose that the nasal route for benzodiazepines may be better overall for     home treatment and easier to administer (see Wermeling, 2009). For many out of hospital     situations, nasal benzodiazepines can be more convenient and more comfortable than rectal     treatment. In addition to the above benefits, nasal benzodiazepines are rapidly absorbed by     the blood vessels in the nose and the time of drug administration and cessation of seizures     may thus be reduced using nasal routes. This study sets out to characterize how fast buccal     and nasal treatments begin to work on the brain by monitoring brain waves during     administration of the drug, and to determine whether nasal or buccal administration is best.   "
150319|NCT01316432|"     The purposed of the study is to evaluate the pharmacokinetics (PK) response of continuous     subcutaneous (SQ) infusion of cenderitide, as compared with a single SQ bolus.   "
150320|NCT01316419|"     This observational study is designed to evaluate the effects of Twynsta tablets with life     style modifications on blood pressure, quality of life, and other risk factors in Korean     patients with hypertension in a routine clinical practice setting.   "
150321|NCT01316406|"     The aim of this study is to evaluate the safety and efficacy of ATH008 cream in patients with     Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine therapy. In part     I, the safety and plasmatic levels of the active ingredient and its metabolite will allow to     determine the most appropriate and beneficial dose for the second part of the study. In Part     II, the efficacy of ATH008 cream in reducing the number of patients presenting PPES grade 2/3     secondary to capecitabine therapy following a four times daily application will be tested.   "
150322|NCT01316393|"     In the present study with a randomized, cross-over, blind, placebo controlled design, the     effects of a salivary substitute product and a new mucoprotective product with similar     mechanisms of action but with different composition and characteristics will be evaluated in     cancer patients suffering from xerostomia.   "
150323|NCT01316380|"     The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium     compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be     delivered via Respimat inhaler and will be examined on top of maintenance inhaled     corticosteroid treatment in patients with mild persistent asthma. Efficacy and safety will be     assessed by measuring the effects on lung functions, effects on lung exacerbations, effects     on asthma control and numbers of adverse events.   "
150324|NCT01316367|"     BACKGROUND: Individual health education is considered to be essential in the overall care of     patients with type 2 diabetes (DM2), although there is some uncertainty regarding its     metabolic control benefits. There have been very few randomized studies on the effects of     individual education on normal care in DM2 patients with a control group, and none of these     have assessed the long-term results. Therefore, this study aims to use this design to assess     the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational     Diagnosis, and Evaluation) education model in the metabolic control and the reduction of     cardiovascular risk factors, in patients with type 2 diabetes.      METHODS: An open community randomized clinical trial will be carried out in 8 urban community     health centers in the Northeastern Madrid (Spain). Six hundred patients with DM2 will be     randomized in two groups: PRECEDE or conventional model for health promotion education. The     main outcome measures is glycated hemoglobin A1C, body mass index (BMI), blood pressure,     lipids and control criteria during the 2-year follow-up period.   "
150325|NCT01316354|"     Sedentary lifestyles and increasing obesity are main causes of the global increase in the     prevalence of the metabolic syndrome (Mets) and type 2 diabetic (T2DM). Diet quality,     particularly composition of carbohydrate play also a significant role. The glycemic index     (GI) describes in relative terms rise of blood glucose after ingestion of carbohydrate-rich     food. Purified dietary fibre as β-glucan (BG) has been shown to reduce GI and affect levels     of satiety hormones. In contrast, our knowledge of the physiological effects of arabinoxylans     (AX), which constitute a substantial part of dietary fibre in cereal products, is limited.     The investigators also lack a deeper understanding of the importance of whole grain (whole     grain with whole kernels, and purified dietary fibre) in relation to Mets and T2DM.      Hypothesis: The composition of dietary carbohydrates can be designed so that they improve the     glycemic and insulinaemic responses and increase satiety feeling. This can be detected in     metabolic parameters in subjects with Mets.      The aim of our study is in subjects with Mets to compare the effect of acute consumption of     bread rich in (a) purified AX, (b) purified BG, (c) rye bread with whole kernels (RK), with a     (d) control group with consumption of white bread (WB).      The primary endpoint is GI. Secondary endpoints are the following items: glycemic load,     insulin index, glucose, insulin, glucagon, inflammatory markers, incretins, rate of gastric     emptying, and metabolomics. Also satiety feeling will be measured.      This project will improve opportunities for identifying and designing foods with low GI that     is particularly suited to people who are at high risk of developing T2DM. The investigators     also expect to gain a greater understanding of the metabolic fingerprint, as seen after     ingestion of low-GI foods and thereby gain a molecular understanding of how low-GI foods     affect health by altering metabolic processes. This will give us a deeper insight into the     metabolic processes that are necessary for maintaining normal glucose homeostasis.   "
150326|NCT01316341|"     the pharmacokinetics, pharmacodynamics and safety and tolerability of single and multiple     oral doses of BI 10773 at low dose once daily (q.d.) and high dose q.d. administered to     Chinese female and male patients with type 2 diabetes will be investigated.   "
150330|NCT01316289|"     This prospective case series will essentially examine the influence of reduction quality on     the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures     treated with plate fixation.      The plates used in this trial can be chosen according to the preferences of the surgeon.   "
150331|NCT01316276|"     The purpose of this study is to evaluate the long term safety and tolerability of Arikayce in     Cystic Fibrosis patients. This long-term, open-label, multi-cycle extension study will enroll     subjects who have successfully completed study TR02-108, were compliant with the study     protocol, and did not meet any of the listed study discontinuation criteria. The safety and     tolerability of Arikayce will be evaluated for up to approximately 2 years.   "
150334|NCT01316237|"     A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the     Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve     Subjects with Chronic Hepatitis C Virus Infection.   "
150335|NCT01316224|"     Psoriatic Arthritis (PsA) is a comorbidity that affects a significant proportion of     participants with moderate or severe psoriasis. The purpose of this study was to describe the     profile of patients with moderate or severe plaque psoriasis (Ps) in Colombia and to evaluate     adalimumab efficacy and safety profile.   "
150336|NCT01316211|"     A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal     stenosis with concomitant low back pain by decompression with and without additional     stabilization using the coflex® Interlaminar Technology   "
150337|NCT01316198|"     The objective of the study was to investigate the influence of a intervention with lutein und     zeaxanthin from crucifers on the optical density of the macular pigment of patients with non     exudative age-related maculopathy. It is hypothesized that the applied study beverage     elevates plasma concentrations of the administered xanthophylls and the optical density after     4 weeks of intervention.   "
150338|NCT01316185|"     The purpose of this study is to assess the optimal dose of EBP921 by comparing the efficacy     and safety of 2 dose regimens in patients with chronic HDV.   "
150339|NCT01316172|"     This study intends to evaluate consultation in the Emergency Department. The purpose is to     demonstrate that standardizing communication in the Emergency Department may lead to improved     consultation.   "
150340|NCT01316159|"     Although atherosclerosis is a systemic disease, its manifestations are focal and eccentric,     and each coronary obstruction progresses, regresses, or remains quiescent in an independent     manner. The focal and independent nature of atherosclerosis cannot be due solely to the     presence of systemic risk factors such as hyperlipidemia, diabetes mellitus, cigarette     smoking, and hypertension. Local factors that create a unique local environment are a major     determinant of the behavior of atherosclerosis in a susceptible individual.      The vascular endothelium is in a unique and pivotal position to respond to the extremely     dynamic forces acting on the vessel wall due to the complex 3-D geometry of the artery.     Mechanical forces in general, and fluid shear stress (endothelial shear stress [ESS]) in     particular, elicit a large number of humoral, metabolic and structural responses in     endothelial cells.      Regions of disturbed flow, with low and oscillatory ESS (< 1.0 Pa), are intensely     pro-atherogenic, pro-inflammatory, and pro-thrombotic, and correlate well with the     localization of atherosclerotic lesions. These sites demonstrate intense accumulation of     lipids, inflammatory cells, and matrix degrading enzymes which promote the formation of     high-risk thin-cap fibroatheroma.      In contrast, physiologic laminar flow (1.0-2.5 Pa) is generally vasoprotective. However, as     the obstruction progresses and further limits blood flow through a narrowed lumen, flow     velocity and ESS may increase excessively (> 2.5 Pa) at the neck, and decrease abnormally at     the outlet, increasing the likelihood of platelet activation and thrombus formation.      Identification of an early atherosclerotic plaque likely to progress and acquire     characteristics leading to likelihood of rupture and, consequently, to precipitate an acute     coronary event or rapid luminal obstruction, would permit more definitive pharmacologic or     perhaps mechanical intervention prior to the occurrence of a cardiac event. The potential     clinical value of identifying and eradicating plaques destined to become vulnerable before     they actually become vulnerable is enormous.      The purpose of the PREDICTION Trial is to identify high-risk coronary lesions at an early     time point in their evolution, to follow the natural history of these lesions over a 6-10     month period, and to confirm that these high-risk lesions are likely to rupture and cause an     acute coronary syndrome (ACS) or develop rapid progression of a flow-limiting obstruction.     The hypothesis is that local segments in the coronary arteries with low ESS and excessive     expansive remodeling will be the sites where atherosclerotic plaque develops, progresses, and     becomes high-risk, leading to a new cardiac event. This study is being conducted in Japan as     patients are clinically evaluated with followup coronary angiography and IVUS in a routine     manner at 6-10 months following their initial percutaneous coronary intervention (PCI) for an     ACS.      This is a natural history and a clinical outcomes study in patients who initially present     with an ACS. The natural history portion of the study is designed to describe the temporal     progression of atherosclerosis in segments of coronary arteries with low ESS and expansive     remodeling using intracoronary vascular profiling techniques utilizing intravascular     ultrasound (IVUS) and coronary angiography. The clinical outcomes portion of the study is     designed to evaluate the efficacy of coronary vascular profiling to predict segments of     coronary arteries that will become areas of rapid plaque growth or rupture leading to     recurrent major clinical coronary events.      Five hundred (500) patients with acute coronary syndrome undergoing PCI for a culprit lesion     are to be enrolled in the study to undergo coronary vascular profiling at the time of the     index catheterization procedure. Up to 374 consecutive patients with at least one low ESS     subsegment are to have follow-up coronary angiography and IVUS at 6-10 months to allow for at     least 300 patients with analyzable intracoronary vascular profiling data for assessment of     lesion natural history. All patients are to have a one-year clinical follow-up to assess for     new cardiac events, followed by two additional years of extended clinical followup.   "
150341|NCT01316146|"     The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancer. This research study combines two different ways of fighting disease:     antibodies and T cells. Antibodies are proteins that protect the body from diseases caused by     germs or toxic substances. They work by binding those germs or substances, which stops them     from growing and causing bad effects. T cells, also called T lymphocytes, are special     infection-fighting blood cells that can kill other cells, including tumor cells or cells that     are infected with germs. Both antibodies and T cells have been used to treat patients with     cancers: they both have shown promise, but have not been strong enough to cure most patients.     Investigators hope that both will work better together.      Investigators have found from previous research that they can put a new gene into T cells     that will make them recognize cancer cells and kill them. Investigators now want to see if     they can attach a gene to T cells that will help them do a better job at recognizing and     killing lymphoma cells.      The new gene that investigators will put in T cells makes an antibody called anti-CD30. This     antibody sticks to lymphoma cells because of a substance on the outside of the cells called     CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been     strong enough to cure most patients.      For this study, the anti-CD30 antibody has been changed so that instead of floating free in     the blood it is now joined to the T cells. When an antibody is joined to a T cell in this     way, it is called a chimeric receptor. These CD30 chimeric receptor-activated T cells seem to     kill some of the tumor, but they don't last very long and so their chances of fighting the     cancer are unknown.   "
150342|NCT01316133|"     This study is to evaluate efficacy and safety of tacrolimus with steroid by observing     remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid     monotherapy.   "
150343|NCT01316120|"     Human papillomavirus (HPV) assays are likely to be used in cervical cancer screening. Our     objective is to simplify the method of collection of female genital tract specimens by     determining if vaginal dry swabs are as accurate as the standard transport medium for HPV     diagnosis.   "
150344|NCT01316107|"     This study is to evaluate long-term safety and efficacy after concomitant administration of     ASP1941 and Nateglinide inhibitor in Japanese patients with type 2 diabetes mellitus.   "
150345|NCT01316094|"     This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in     type 2 diabetic patients with mild to moderate renal impairment.   "
150346|NCT01316081|"     In obese children, low antioxidant vitamin intake and reduced antioxidant capacity are     common. Weight reduction reduces subclinical inflammation in obese subjects, and, similarly,     antioxidant vitamins have been shown to reduce the expression of proinflammatory cytokines.     Moreover, antioxidants reduce oxidative stress which influences endothelial function and     might play a crucial role in the pathogenesis of obesity-related disorders. Furthermore,     overweight children and adults have a markedly increased risk for iron deficiency. The     mechanism linking obesity with iron deficiency is unclear. Growing evidence suggests that the     elevated inflammatory status associated with obesity increases circulating hepcidin and this     contributes to iron deficiency. Weight reduction has been shown to be associated with reduced     inflammation and serum hepcidin concentrations, and an improved functional iron state. Thus,     reducing inflammation in obese children may improve iron metabolism and reduce their risk of     iron deficiency.      Therefore, positive effects on subclinical inflammation, hepcidin/iron status and metabolic     risk factors in obese children during weight loss may be enhanced by supplementation with     antioxidants.      The aim of the present study is to investigate the effect of 4-month antioxidant     supplementation on subclinical inflammation, hepcidin, iron status and components of the     metabolic syndrome in overweight children undergoing an outpatient weight-loss program.      Our hypotheses are: 1. During an outpatient weight loss program, antioxidant supplementation     will reduce oxidative and inflammatory stress associated with obesity to a greater extent     than weight loss alone. 2. This will have two effects, compared to weight loss alone: a.It     will reduce circulating hepcidin concentrations, and improve iron status. b.It will improve     metabolic and cardiovascular risk factors.      Subjects The investigators plan to enroll 50 children who are participants in outpatient     weight-loss programs in the German part of Switzerland. Enrollment will be done with the     agreement and assistance of the physician supervising the weight-loss program, and the timing     of the study measurements will be incorporated within the existing program schedule. It is     anticipated that the baseline blood sample for this study will be obtained from the regular     baseline venipuncture for the weight-loss study. Criteria for participation include age     between 10 to 18 years and a BMI over the 85th percentile for age and sex. Exclusion criteria     include major medical illnesses, including gastrointestinal, inflammatory, bleeding and/or     endocrine disorders, a history of nephrolithiasis, unusual dietary habits (e.g.     vegetarianism), major food allergies or intolerances (lactose, gluten), smoking, and use of     chronic medications or vitamin/mineral antioxidant supplements.      Study design The study will be a double-blind, randomized, placebo-controlled intervention     trial. Children will be randomly assigned to one of two groups: antioxidant (AO) or placebo     (P) supplement. If it is necessary to enroll children from different weight-loss programs,     then randomization will be stratified by program. During the 4-month weight loss period, the     AO group will consume oral supplements of ascorbic acid (500mg), alpha tocopherol (400 IU),     and 50 µg selenium (all from Burgerstein Vitamins, Rapperswil-Jona, Switzerland) each evening     with diner, whereas the P group will consume identical-appearing placebo supplements.   "
150347|NCT01316068|"     Current therapies targeting albuminuria in diabetic nephropathy leave residual urinary     albumin secretion, which meanwhile leave residual cardiovascular risk. Previous studies     demonstrated that sulodexide could reduce albuminuria in type 2 diabetic patients. But no     data concerning Chinese population is available. The investigators aim to provide evidence of     effects of sulodexide on diabetic nephropathy in Chinese diabetic patients. Further the     investigators also test the hypothesis that sequential administration of intravenous and oral     replacement of the drug would gain an earlier and greater reduction of albuminuria, compared     with oral use only.   "
150348|NCT01316055|"     The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram)     tablets in healthy adult volunteers and those with mild and moderate renal impairment, and     examine between group comparisons.   "
151072|NCT01306396|"     The aim of the present study is to find out if a dietary intervention mainly focusing on     fructose reduction has a preventive effect on the development and progression of NAFLD and     the metabolic syndrome in overweight children.   "
150349|NCT01316042|"     The primary objective of this study is to determine the safety and efficacy of metformin in     lowering serum DHEAS levels in girls with premature pubarche and secondary, to observe     changes in hormones associated with pubertal development including gonadotropins, sex     steroids, insulin, adipocytokines, and growth factors.   "
150350|NCT01316029|"     The purpose of this study is to determine the symptomatic changes after a single session of     laying-on-of-hands in various settings, and to evaluate optimal conditions for the outcomes.   "
150351|NCT01316016|"     The purpose of this study is to determine whether daily intake of a drink containing rose hip     powder reduces risk markers of type diabetes and cardiovascular disease.   "
150352|NCT01316003|"     The aim of this study is to investigate the incidence and possible causes of obscured or     disrupted cone outer segment tips line at fovea in spectral-domain optical coherence     tomography images of normal eyes.   "
150437|NCT01314885|"     A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it     has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute     inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an     internal control for the study.   "
150353|NCT01315990|"     The purpose of this interventional study is to assess the progression free survival (one     year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal     prophylaxis.      Further Objectives:        1. Development of acneiforme follicular exanthema >= grade 2        2. Duration until development of acneiforme follicular exanthema >= grade 2        3. Development of paronychia        4. Development skin fissure (hand and foot)        5. Objective remission according RECIST 1.1        6. Rate of secondary resections of liver metastasis with a curative approach        7. Assessment of safety and tolerability        8. Overall survival        9. Progression free survival   "
150354|NCT01315977|"     Aging is associated with increased risk of various diseases, and much attention is given to     the use of natural products (like herbs) and 'functional food', such as teas, for healthy     aging.      The body is continuously exposed to potentially damaging agents (known as free radicals). The     imbalance between the amount of free radicals and that of antioxidants in the body is known     as oxidative stress. It is known that Type 2 DM is a state of increased oxidative stress,     which is thought to lead to many long term complications of Type 2 DM, such as heart disease,     vision problems and kidney failure. Antioxidant therapy, including increased consumption of     antioxidant rich foods and beverages such as green tea, has been suggested as possibly     beneficial in lowering the risk of these complications.      The purpose of this study is to examine the effects of regular intake of green tea on indices     of oxidative stress and antioxidant defense within cells, plasma and urine so as to     investigate if regular intake of green tea can be recommended for health promotion.   "
150355|NCT01315964|"     Plant stanol esters as part of daily diet can decrease serum level of LDL-cholesterol up to     10%. This decrease diminishes the risk of development of premature atherosclerosis and it´s     complications (e.g., acute myocardial infarction) in adult human subjects.      The purpose of the present study is to evaluate among healthy human subjects (N=100) effects     of plant stanol esters (3 grams/day for 6 months) as part of daily diet in margarine on     arterial endothelial cells, arterial stiffness, autonomic innervation of the arteries,     arterial blood flow and serum fats. The non-invasive arterial measurements (VaSera®, EndoPat®     and WinCRPS®) are performed and blood samples are taken at the beginning and at the end of     the 6-month-long study period. Also questionnaires concerning healthy, and life and dietary     habits are fulfilled. Dietary records (twice for a 3-day-period) are done.      Hypothesis of the study is that a dietary serum cholesterol lowering intervention has     beneficial influence on the early prognostic markers of premature atherosclerosis.   "
150356|NCT01315951|"     The goal of this research is to demonstrate the use of petroleum jelly in prevention of     nonscalp seborrheic dermatitis exacerbations at the first signs of a flare. In doing so, it     will decrease the chronic use of topical steroids. The use of petrolatum should have     favorable outcomes for patients, without the side-effects.   "
150357|NCT01315938|"     The purpose of this study is to investigate the clinical efficacy of abatacept on disease     activity in polymyositis, and dermatomyositis patients.   "
150358|NCT01315925|"     SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze     risk factors for developing an invasive fungal infection in patients with newly diagnosed     Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those     related to normal activities of daily life, such as occupation, location and type of     residence, consume of tobacco, alcohol and others).   "
150359|NCT01315912|"     In a prospective interventional study, 44 Clomiphene resistant infertile patients were     selected from Abolfazl Infertility Clinic of Bushehr University of Medical Sciences.     Letrozole was given orally in a dose of 2.5mg, 5mg and 7.5mg, respectively. If the patient     displayed no response, the dosage was increased. The size of follicle, endometrial thickness,     estradiol, complications and clinical pregnancy rate were evaluated as the final outcome.   "
150360|NCT01315899|"     Raynaud's phenomenon (RP) is a disorder of the digital blood vessels resulting in episodic     impairment of blood flow. During an attack of RP which commonly affects the hands and feet     these arteries contract briefly which limits the blood flow (this is called a vasospasm) and     deprived of blood the skin turns white then blue. The aim of this study is to prove the     concept that ORM-12741 can prevent these blood vessel spasms.   "
150361|NCT01315886|"     The purpose of this study is to evaluate safety and efficacy when using a novel dose     conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl     (Abstral) for treatment of breakthrough cancer pain (BTcP).   "
150362|NCT01315873|"     Patients with myeloma that has either not responded to previous treatment or has returned     after previous treatment will be given a combination of the drugs bendamustine and     bortezomib.      The bortezomib and bendamustine will be given using an intravenous line (IV) on days 1 and 4     of each cycle, with bortezomib being given first, before each dose of bendamustine. Each     cycle will be 28 days long, so patients will be treated the first week of each cycle and then     have 3 weeks 'off' (without any treatment). Disease assessments will be performed on day 22     of each cycle. Patients will receive the study drugs until their disease progresses or they     are withdrawn from the study.      In other studies, bendamustine seems to work well with other drugs. Thus, this study hopes to     show that the combination of bortezomib and bendamustine will have activity in     relapsed/refractory myeloma.   "
151171|NCT01305109|"     The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary     objective of evaluating the efficacy of three doses of ORV 116E, 10^5.0 FFU, against severe     rotavirus gastroenteritis, in comparison with a placebo in India.   "
150386|NCT01315548|"     The aim of the study is to assess the accuracy of real-time perfusion imaging pattern of     pancreatic focal lesions visualized by contrast-enhanced harmonic endoscopic ultrasound     (CEH-EUS) for the differential diagnosis between chronic pseudotumoral pancreatitis and     pancreatic cancer in a prospective multicenter design.      The study will include patients with focal pancreatic masses evaluated by CEH-EUS and     EUS-FNA. The diagnosis is usually unknown in the moment of the initial evaluation, the     patients being included based on a suspicion of focal pancreatic masses after transabdominal     ultrasound, CT or MR examinations. However, after a complete evaluation, a final diagnosis     will be reached based on the combination of EUS-FNA cytology/pathology, surgical pathology     and minimum 12 months follow-up.   "
151540|NCT01300260|"     The purpose of this study is to measure the effect of LY2189265 to increase insulin levels in     response to glucose intake.   "
150363|NCT01315860|"     Low back and posterior pelvic pain are common in pregnant females. Previous studies have     demonstrated disability and it is estimated that all women experience some degree of     musculoskeletal discomfort during pregnancy. Borg-Stein et. al. found 25% of pregnant females     have temporarily disabling symptoms.      There is demonstrated controversy over the mechanism of low back pain in pregnancy. The     biomechanical theory implies that the enlarging uterus causes the maternal center of gravity     to move anteriorly causing stress on the low back. Jensen et. al. demonstrated that weight     gain correlated with biomechanical changes. The changes were measured by weight gain in     segmental regions of the body and in principal moments of inertia from the sit to stand     movement. Literature does not demonstrate a specific correlation between weight gain and the     biomechanical changes of sway rate, lumbosacral angle and center of gravity. These three     measurements may have a correlating effect on the underlying cause of low back pain in     pregnant women.      This study aims to determine the correlation between weight gain of pregnant females and the     biomechanical changes of sway rate, lumbosacral angle and center of gravity. The change in     weight over the last two trimesters will be correlated with the sway rate, lumbosacral angle     and center of gravity. The degree of symptomatic low back pain as measured by the Oswestry     Low Back Pain Scale will also be correlated with the sway rate, lumbosacral angle and center     of gravity.   "
150364|NCT01315847|"     The purpose of this study is to determine the receptor occupancy (RO) associated with     telcagepant (MK-0974) administration based on displacement of [11C]MK-4232 from the CGRP     receptors in the brain using PET. The study enrolled healthy participants (Part I) and     migraine patients (Part III). Due to a protocol amendment, study Part II was not conducted.   "
150365|NCT01315834|"     The main purpose of this study is to examine the contribution of personality traits to     marital satisfaction and well -being among couples coping with Coronary Heart Disease (CHD)     and couples from the general population, and to health promoting behaviors and physical     recovery among the ill partners.   "
150366|NCT01315821|"     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal     system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in     newborn infants whose birth weights are < 1500 gr. Although bifidobacterium and lactobacilli     sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii     has not been used in the prevention of NEC in very low birth weight infants yet. The     objective of this study is to evaluate the efficacy of orally administered S boulardii in     reducing the incidence and severity of NEC in very low birth weight infants.   "
150367|NCT01315808|"     The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal     population with risk factors of developing type 2 DM. There is no known diabetes model for     predicting incident diabetes in an individual which takes into account the rate of change of     HbA1c (dx/dt). In such cases, the rate of change of HbA1c may give the physicians lead time     needed to implement the Diabetes Prevention Program measures.   "
150368|NCT01315795|"     An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide     autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease,     including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.   "
150369|NCT01315782|"     This is an observational study to understand the changes in alveolar dead space in medical     critically ill patients with severe infection (severe sepsis) requiring mechanical     ventilation and the possibility to predict multi-organ failure.      The measurement of alveolar dead space used to require sophisticated equipment and time. New     ventilators have microprocessors that allow rapid mathematical calculation with minimal     intervention.   "
150370|NCT01315769|"     This study aimed to compare the pelvic floor muscle (PFM) strength in nulliparous and     primiparous women. Subjective evaluation of PFM strength was performed vaginal digital     palpation (TDP). The objective evaluation of PFM strength was assessed using a portable     perineometer. All parameters were performed at one moment in G1, and in G2, during the 20th     and 36th weeks of pregnancy, and 45 days after the delivery. Pregnancy and vaginal delivery     may cause weakness of PFM.   "
150371|NCT01315756|"     It is hypothesized that the use of the mobile phone-based self-help system FTA, and with the     patients as active players, will improve diabetes self-management reflected by improved     glycemic control and lipids, self-care behaviours and lifestyle changes such as improved     dietary habits and increased physical activity, compared with usual care. Following this; it     is also hypothesized that this will also lead to a reduction in overall risk for diabetes     complications (expressed by reduction in e.g., 5 year absolute risk for coronary artery     disease as calculated using the Swedish National Diabetes Register's risk calculator) and in     the prevalence of the metabolic syndrome (e.g., as defined by the International Diabetes     Federation). It also hypothesized that health counselling based on TTM and CBT by a diabetes     nurse, and with individualized feedback via sms from the diabetes nurse, may have an     important function as a supplement to the self-help system (FTA). In addition, it is     hypothesized that the patients' health status and diabetes-related quality of life (HRQL)     will improve. The results of this study may show that a commonly used tool like the mobile     phone, and also mobile phone together with health counselling, fitted into the patients'     daily life, is more effective and cost-effective than standard care.   "
150372|NCT01315743|"     The goal of this exploratory pilot study was to develop and test the acceptability and     feasibility of an innovative alternative high school-based intervention to prevent further     weight gain and/or promote weight loss among a sample of ethnically and economically diverse     adolescents.   "
150373|NCT01315730|"     The purpose of this research project is to test the effects of exposure of different forms of     tactile speech feedback on overt stuttering frequency.   "
150374|NCT01315717|"     The purpose of this study is to examine and to compare gait characteristics under single- and     dual-task conditions among healthy subjects together with AD patients at different stages of     disease (i.e., pre-dementia, mild and moderate dementia stages).   "
150375|NCT01315704|"     The purpose of this study is to compare characteristics of gait and balance measured among     patients with Alzheimer's disease or related disorders separated into 3 groups according to     the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine     the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to     establish a database at Angers University Memory Centre.   "
150376|NCT01315691|"     A major factor in the respiratory health of Cystic Fibrosis (CF) subjects is the prevalence     of chronic Pseudomonas aeruginosa infections. The Pseudomonas aeruginosa infection rate in CF     patients increases with age and by age 18 years approximately 85% of CF patients in the US     are infected. Liposomal amikacin for inhalation (Arikace™) was developed as a possible     treatment for chronic infection due to Pseudomonas aeruginosa in CF patients.      The purpose of this double-blind, placebo controlled study is to determine whether Arikace™     is effective in treating chronic lung infections caused by Pseudomonas aeruginosa in Cystic     Fibrosis subjects. The study will enroll approximately 300 subjects in clinics in the US,     Canada, Europe, Australia and New Zealand. Subjects will be randomized to 590 mg Arikace™ or     placebo and will receive treatment for 28 days followed by a 56 day safety follow-up period.     The subjects will be required to visit the clinic 8 times (including the Screening visit)     over a period of approximately 3 months. No overnight stays at the clinic will be required.     At the completion of the TR02-109 protocol, subjects who have consented and meet study safety     criteria may enroll in the long-term, open-label, multi-cycle extension study of 590 mg of     Arikace™ (under a separate protocol TR02-110).   "
150377|NCT01315678|"     A major factor in the respiratory health of Cystic Fibrosis (CF) subjects is the prevalence     of chronic Pseudomonas aeruginosa infections. The Pseudomonas aeruginosa infection rate in CF     patients increases with age and by age 18 years approximately 85% of CF patients in the US     are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible     treatment for chronic infection due to Pseudomonas aeruginosa in CF patients.      The purpose of this European Registration study is to determine whether Arikayce™ is     effective in treating chronic lung infections caused by Pseudomonas aeruginosa in Cystic     Fibrosis subjects. The effectiveness, safety and tolerability of Arikayce™ will be compared     to TOBI, an inhalation antibiotic already available for use. The study will enroll     approximately 300 subjects in clinics in Europe and Canada. Subjects will be required to     visit the clinic 9 times (including the Screening visit) over a period of approximately 6     months. No overnight stays at the clinic will be required.   "
150378|NCT01315665|"     The purpose of this study to investigate the effect of sulforaphane from macerated broccoli     sprouts in humans and to evaluate less invasive methods of assessing potential     anti-inflammatory drugs in CF.   "
150379|NCT01315652|"     The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse     checking the preventive modalities and/or the presence of comorbidities such as infections (     e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin,     antiaggregant,anti-hypertensive treatment…), cancers (e.g.mammography,…), osteoporosis (e.g.     bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the     impact of an educational program aimed at permitting rheumatoid arthritis patients to     auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).   "
150380|NCT01315639|"     The aim of this study is to examine the relationship between plasma putative biomarkers for     Alzheimer's disease (i.e. Ab40 amyloid and total Ab42 amyloid, free, bound, free/bound,     truncated, sAPPα) and :        -  the risk of conversion of individuals with Mild Cognitive Impairment (MCI) into          Alzheimer's disease (AD),        -  the Alzheimer's disease progression rate.   "
150381|NCT01315626|"     A study of an educational intervention of primary care practice physicians to assist in the     identification of patients who have Bronchiectasis and to assess the effectiveness of the     specific didactic educational intervention targeting primary care physicians in the     recognition of Bronchiectasis.   "
150382|NCT01315613|"     Acute pancreatitis is characterized by an inflammatory storm which regulatory pathways are     not well known. The IL-1 cytokine family is activated early during acute pancreatitis and     secretion of alarmins is speculated during pancreatic necrosis. IL-33 is a member of the IL-1     family, it can act as an alarmin and its receptor, ST2, is known to sequester MyD88 which     might regulate the acute pancreatitis inflammatory storm. The aim of this study is to     investigate ST2 pathway in human acute pancreatitis and in murine experimental models of     acute pancreatitis.   "
150383|NCT01315587|"     The pilot studies have showed that theta burst stimulation (TBS) can have the more rapid and     durable effects to the apply traditional rTMS protocols. The aim of this study is to     investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms     and remission of cognitive functioning in patients with schizophrenia. In a randomized,     double blind clinical trials, 30 patients with schizophrenia in Razi psychiatric hospital     will be assigned to receive repetitive TMS; theta burst, or sham TMS, daily; for 20 sessions.     The negative symptoms and cognitive functioning will be assessed before the treatment (pre     test) during the treatment (session 10), and after the treatment (post test).QEEG and LORETA     apply before and after rTMS in all subjects.   "
150384|NCT01315574|"     The purpose of the study is to compare the efficacy of FDA-approved Travoprost (Travatan Z)     and Latanoprost (Xalatan)as anti-glaucoma treatment. Several studies indicate that glaucoma     medications may be associated with decreased tear production and tear film break-up time     (TBUT), and increased inflammatory cells in the conjunctiva (membrane lining of the eye lids     and the covering of the eye) leading to dry eye. Normal tear film (coating of the eye) is     continuous and blinking maintains the tear film continuity. If you keep your eyes open long     enough without blinking, the tear film will start breaking up. Your eye will feel     uncomfortable forcing you to blink. In patients with dry eyes, the tear film is unstable, and     breaks up faster. Therefore the tear break up time in patients who have dry eyes is shorter.      In this study, the investigators will be comparing the two previously mentioned FDA-approved     eye drops Latanoprost and Travoprost. The difference between the two medications is a     preservative called benzalkonium chloride (BAK). Latanoprost contains BAK while Travoprost     does not. The investigators will be comparing the efficacy of each medication in lowering IOP     as well as trying to track the density of immune cells across the corneal surface by taking     photos of your eye. The investigators will also be assessing whether either drop leads to     symptoms of dry eye by comparing results from ocular surface exam tests such as TBUT.   "
150385|NCT01315561|"     Motion style acupuncture treatment(MSAT) is a treatment method in which the patient is     exposed to active or passive movement and exercise during acupuncture, as opposed to     conventional acupuncture. The purpose of this study is to investigate the effect of MSAT in     the treating pain and severe functional disability in acute LBP patients.   "
150387|NCT01315535|"     The literature does not discuss if the fast oral appliance titration (30 days period) in     Obstructive Sleep Apnea Syndrome (OSAS) treatment, may improve subjects quality of life in     such brief period. Temporomandibular dysfunction-related (TMD) is one of the most important     side effects observed in OSAS treatment with oral appliance. Since the effectiveness of     mandibular exercises in the control of TMD pain has already been verified, it may play a     fundamental role in the support of the fast oral appliance titration.   "
150388|NCT01315522|"     Endoscopic retrograde biliary drainage (ERBD) is now widely accepted as the standard     intervention for the relief of obstructive jaundice in patients with unresectable malignant     biliary obstruction. Although plastic stents (PSs) were developed earlier, self-expandable     metal stents (SEMSs) are now used widely as the initial choice for ERBD in this setting, as     SEMSs offer longer patency.However, SEMSs do become occluded in some patients. There are a     limited number of reports on the management of occluded SEMS with various results. The aim of     this study is to compare the efficacy of ComVi stents SEMSs with uncovered SEMS in subsequent     ERBD after the occlusion of initial SEMSs.   "
150389|NCT01315509|"     The investigators aim to assess the dental status of psychiatric patients suffering from     severe mental illness (schizophrenia, bipolar disorder, ptsd, resistant depression).   "
150390|NCT01315496|"     This study is to determine whether the intravenous application of 'Ⅳ-Globulin S inj. (Human     Immunoglobulin G)' can reduce mortality in patients with severe sepsis or septic shock.   "
150391|NCT01315483|"     In the United States, overweight (BMI > 25 but < 30 Kg/m2) and obesity (BMI > 30Kg/m2) are     increasing at epidemic rates. A significant association exists between being overweight or     obese and breast cancer recurrence and survival. However, evidence continues to accumulate     indicating that achieving or maintaining a healthy weight for height (Body Mass Index, BMI,     18.5-25Kg/m2) is associated with a reduced risk for breast cancer and with a decrease in     breast cancer associated mortality. Despite this, there is a lack of randomized controlled     trials exploring this association and how the process of fat loss or being successful in     actually reaching a healthy weight for height differentially affects biomarkers for cancer     recurrence.      Many dietary approaches for weight loss are currently available to the public, and each     purports to offer advantages. However, there is little scientific evidence to indicate how     these dietary approaches, some of which vary markedly in the foods that they limit or     exclude, affect biomarkers for breast cancer risk. In particular, it is not know whether the     critical factor in relation to weight and breast cancer is simply weight loss (negative     energy balance), irrespective of the manner in which it is achieved, or if certain dietary     approaches affect breast cancer risk biomarkers more favorably than others. Published data     from our laboratory suggest that dietary pattern does matter, and therefore the goal of this     study is to investigate the effects of two popular weight loss dietary approaches that differ     in the extent to which they limit carbohydrate or fat consumption (with effects on dietary     glycemic load) compared to a usual care group on prognostic markers for cancer recurrence in     postmenopausal breast cancer survivors. The investigators hypothesize that in addition to the     anticipated effects of fat loss on circulating levels of bioavailable sex steroid hormones,     that the effects of excess fat on breast cancer prognosis can be attributed to three     interrelated metabolic processes that affect cancer progression: altered glucose metabolism,     chronic inflammation and excessive cellular oxidation.   "
150392|NCT01315470|"     The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of     recurrent implantation failure in IVF patient with cause unknown or due to thin endometrium.     Several studies showed that GCSF improves embryo development and implantation and increase     pregnancy rate.   "
150393|NCT01315457|"     The aim of this study is to propose infection prophylaxis from Asian multinational     retrospective analysis of infectious complications in patients who were treated with     alemtuzumab   "
150394|NCT01315444|"     Gastro esophageal reflux disease and ulcer related or non-ulcer dyspepsia, attacks 20% of the     Western population. These millions of patients are treated continuously with PPI for     different periods, many for many years. Recently, rebound acid hypersecretion was recognized     as a major clinical event after cessation of PPI therapy. Sustained hypergastrinemia due to     daily PPI therapy causes increased acid-secretory capacity that appears when the drug is     stopped. The transient increase in blood and urinary pH following gastric secretion has been     termed the alkaline tide phenomenon. Carbonic acid, formed in the presence of the enzyme     carbonic anhydrase, neutralizes intracellular hydroxyl ions produced as a result of luminal     acid secretion. The bicarbonate generated is removed from the cell via the baso-lateral     chloride bicarbonate exchanger. The investigators have shown in several studies that this     phenomenon parallels acid secretion. Thus, stimulation of acid secretion with test meal     increased base excess maximally after 45 minutes and these changes parallel peak acid output     measured in gastric aspirate. The investigators hypothesize that gradual step down cessation     of PPI will prevent this clinical relevant event. By measuring alkaline tide after PPI     cessation the investigators may prove this hypothesis.   "
150395|NCT01315431|"     This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in     combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through     14) in a 21-day cycle.   "
150396|NCT01315418|"     This multicentric, randomized, double-blind and controlled study aims to examine the effect     of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001     (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common     infectious diseases (cumulated number of infections during the intervention period: primary     criteria), and on the Quality of Life in adults submitted to multi-stressor situation.     Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for     7-weeks.   "
150432|NCT01314950|"     The purpose of this study is to conduct a two-year randomized, controlled clinical trial to     improve functioning among older adults with Alzheimer's disease by comparing a control group     receiving best practices primary care with an intervention group receiving best practice     primary care plus a home-based occupational therapy intervention.   "
150819|NCT01309828|"     The purpose of this study is to evaluate long term safety and tolerability of azilsartan     medoxomil and chlorthalidone, once daily (QD), compared with olmesartan medoxomil and     hydrochlorothiazide in hypertensive participants with moderate renal impairment.   "
150411|NCT01315223|"     Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure     (AHF) several times a year. Currently, we have no method for prediction of future     developments of AHF. In our center we have investigated the monitoring of lung impedence as a     predictor for future deterioration. It was found that a decrease in lung impedence of more     than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we     try to prove the hypothesis that preventive treatment according to lung impedence value may     prevent future hospitalizations for AHF and improve clinical outcome.      Patients recruited by year:      2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5   "
150397|NCT01315405|"     After few years of evolution, patients with Parkinson's disease may develop apathy, with     different degrees of severity. Apathy is characterized by a loss of interest for the others     and for activities. The lack of social interactions in these patients may be due to an     impairment in decoding emotional facial expression. Indeed, facial expression recognition,     which is necessary to understand other's emotional state, requires a subclinical facial     mimicking of the expression observed. Yet, one of the clinical signs of PD is amimia.      This study aims to determinate if there is a facial mimicry disorder in PD ( Parkinson's     disease )patients with emotional facial expression (EFE) recognition impairment, compared to     healthy control subjects. We also want to know if this facial mimicry disorder is primary     (subtended by facial mobility impairment, that is to say amimia) or secondary (related to the     mirror neuron systems that allows us to activate similar neural networks when observing and     feeling a specific emotion)   "
150398|NCT01315392|"     Delayed wound closure is considered by many to be the standard of care for the treatment of     an open fracture. This study was conducted to determine the feasibility of a large     multi-center prospective randomized clinical trial and collect the pilot data needed to     compete for the funding for such a trial. The study was designed to compare immediate and     delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes     were the infection rates and fracture related complications in patients treated with     immediate or delayed wound closure strategies.   "
150399|NCT01315379|"     The purpose of this study is to determine whether Prolonged Exposure Therapy (PE)is effective     in the treatment of post-traumatic stress symptoms in children and adolescents with mild     traumatic brain injury (m-TBI) due to motor vehicle accident.   "
150400|NCT01315366|"     The optimal dose of vitamin D needed to optimize beneficial effects on musculoskeletal     outcomes remains to be defined. Equally unclear is the impact of vitamin D on fuel metabolism     and insulin sensitivity in human subjects. Thus, the overall objective of this proposal is to     test the hypothesis that in ambulatory overweight elderly individuals, vitamin D     administration at doses higher than currently recommended will:        1. Have a salutary effect on parameters of glucose and fuel metabolism. It will thus          decrease indices of insulin resistance, improve lipid profile, and decrease markers of          cardiovascular disease including adipokines, inflammatory cytokines, and markers of cell          adhesion.        2. Have a superior effect on indices of mineral and musculoskeletal metabolism, including          bone remodeling markers, lean mass, and bone mineral density.      We will investigate whether this effect is modulated by entry status of vitaminD and PTH as     detailed below   "
150401|NCT01315353|"     Women sometimes develop cancer in an area called the cervix, which is the opening to the     uterus, or womb. Women who have HIV are more likely to get this kind of cancer than women who     do not have HIV. Nearly all of these cancers are caused by another virus, called human     papilloma virus (or HPV). Other times, the cause of this cancer is not known.      The investigators are looking for a better way to prevent cervical cancer. This study is     comparing two different methods to prevent cancer of the cervix in women who have HIV. This     study will also see if these methods are safe and tolerable in women who have HIV.   "
150402|NCT01315340|"     Ocular rigidity characterizes the relationship between pressure and volume changes in the     human eye and is expressed as a macroscopic coefficient. Outflow facility is a measure of the     resistance of the conventional outflow pathway and represents a parameter that is of interest     in glaucoma.      Difficulties in the measurement of ocular rigidity in the living human eye have limited our     knowledge on this parameter. However, ocular biomechanics have been implicated in the     pathogenesis of this disease. The aim of this study is to characterize the pressure volume     relation and quantify ocular rigidity and outflow facility in glaucomatous and normal eyes.     For this purpose, the investigators have recently developed a manometric method for the     measurement of ocular rigidity and outflow facility.   "
150403|NCT01315327|"     This study examines the safety and efficacy of omega-3 fatty acids (fish oil) for the     treatment of Tourette's Disorder.   "
150404|NCT01315314|"     The purpose of this study is to evaluate the effects of neutral pH and low glucose     degradation product (GDP)-containing peritoneal dialysis fluid (PDF) on systemic inflammation     and endothelial dysfunction markers in incident PD patients.   "
150405|NCT01315301|"     Aim of the study is to determine optimal time to initiate anti-retroviral therapy in HIV/TB     co-infected patients who recently started treatment for Tuberculosis by comparing immediate     versus deferred initiation of HAART.      The study will address the following questions;        -  Is it possible to reduce mortality rate and increase survival by early initiation of          HAART during TB treatment with out compromising for adverse drug reaction, toxicity and          immune reconstitution syndrome?        -  What is the risk/ benefit ratio between immediate versus deferred initiation of HAART          during TB treatment with respect to safety/efficacy of TB and HIV co-treatment?        -  When is the most appropriate time to start HAART during TB treatment?   "
150406|NCT01315288|"     The purpose of this study is to determine patient variables, physician presenter variables,     and information variables that might affect clinical decision making in asymptomatic carotid     stenosis. The hypothesis is that information variables are the most significant determinant     of clinical decision making.   "
150407|NCT01315275|"     The purpose of this study is to evaluate the proportion of patients with a 10 letters gain on     Best Corrected Visual Acuity (BCVA) at 6 months in current medical practice.   "
150408|NCT01315262|"     Viagra (Sildenafil citrate) is an orally active selective inhibitor of cyclic guanosine     monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) which is used for the treatment     of erectile dysfunction (ED). Objectives:        -  To test the efficacy of Viagra 100mg on demand vs. Viagra 100mg daily (taken either at          bedtime or 1 hour prior to sexual intercourse) in restoring erectile function following          radical prostatectomy.        -  To test the safety and tolerability of Viagra 100 mg on demand vs. Viagra 100 mg daily          after radical prostatectomy.   "
150409|NCT01315249|"     The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol     and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a     26-week period in patients with moderate to severe COPD.   "
150410|NCT01315236|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of     daily dosing of 590 mg of LAI versus placebo in patients with recalcitrant NTM lung disease.   "
150412|NCT01315210|"     To evaluate the safety and to determine the efficacy of D-ribose for the amelioration of     fatigue in subjects with fibromyalgia. This is a phase IIa, randomized, double-blind,     placebo-controlled, multi-center, multiple dose study of D-ribose versus placebo administered     at doses of 5 g three times a day (TID) over a 12-week period to subjects who are     experiencing fatigue associated with a diagnosis of fibromyalgia.   "
150413|NCT01315197|"     Objectives: Semi experimental Clinical Trial aimed at verifying the effectiveness of massage     for lower back pain occupational as well as to assess the influence of technique in     performing work activities and life in the team nursing.   "
150414|NCT01315184|"     The purpose of this study is to evaluate the whether an automated telephone-based system is     useful and helpful for opioid dependent patients receiving buprenorphine in primary care. The     Recovery Line support system is a Therapeutic Interactive Voice Response system based on     cognitive behavioral therapy (CBT). The Recovery Line support system includes a variety of     modules presenting the basic principles and strategies of CBT. Each module includes learning     sections and activities sections to provide direct guidance in using skills. The Recovery     Line support system is interactive and also includes a questionnaire to help patients     identify problems and recommend modules for use, as well as an inspiration section, an     introduction, and an immediate assistance menu. Following development of an initial system     the current trial will recruit 40 patients receiving buprenorphine maintenance from a     physician provider in the local community. Patients will be randomly (flip of a coin) to     receive the Recover Line Support system or to treatment as usual with their physician.     Patients assigned to TIVR will be trained on the system and provided 24-hr access to the TIVR     system for a four week period. Primary outcome variables will be how long patients remain in     treatment, self-reported abstinence from opioids and other drugs, and abstinence as measured     by weekly drug screens. It is expected that patients assigned to TIVR will better treatment     outcomes than patients assigned to TAU.   "
150415|NCT01315171|"     Insulin treatment often causes the blood glucose levels to fall too low (hypoglycemia).     Hypoglycemia can be associated with confusion and disorientation as well as other symptoms     such as palpitations, sweating and tremors. Medium chain triglycerides (MCT) can be used as a     fuel in the brain during low blood sugar levels and therefore may prevent or reduce some of     the confusion and disorientation seen during hypoglycemia. We would like to determine if a     diet supplemented with medium chain triglycerides can improve cognitive function during     hypoglycemia, diabetes control and also look at brain activity.   "
150416|NCT01315158|"     This will be a randomized controlled trial that compares the rates of sedation related     complications in high risk patients (ASA greater or equal to 3, BMI greater or equal to 30,     those at risk for OSA) undergoing advanced endoscopy procedures with propofol alone compared     to propofol in combination with benzodiazepines and opioids.   "
150417|NCT01315145|"     This is a multi-center, prospective, observational clinical study to compare patient outcomes     following treatment with either the mild® procedure or epidural steroid injection in patients     with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.   "
150418|NCT01315132|"     This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in     matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to     increase overall survival.   "
150419|NCT01315119|"     The investigators hope to learn the value of the SPY ELITE® intra-operative angiography in     reducing post-operative complications associated with low breast skin blood flow after breast     reconstruction using implants.   "
150420|NCT01315106|"     The purpose of this study is to determine how well a new MRI technique called High     resolution 3D diffusion-weighted breast MRI detects breast cancer.   "
150421|NCT01315093|"     The addition of heparin increases pregnancy outcome parameters in poor responders undergoing     In Vitro Fertilisation (IVF)   "
150422|NCT01315080|"     The investigators recently proposed a new hypothesis on the pathogenesis of mammillary     fistulae (MF) suggesting that occlusion of hair follicles by keratinous plugging may     relevantly contribute to the development of MF. The investigators believe that the     pathogenesis of MF mimics the behaviour of hidradenitis suppurative, as both clinical     entities manifest themselves as a chronic, suppurative and recurrent inflammatory process.     This new proposal has led to the present suggestion of a therapeutic alternative for MF.   "
150433|NCT01314937|"     Worldwide, over 2 billion people suffer from worm infections in developing countries. These     infections are especially damaging to the health of children, resulting in both short-term     and lifelong disability. Older children with worm infections are more likely to be stunted,     underweight, vulnerable to other illnesses and perform poorly in school compared to     non-infected children. Large-scale deworming programs in school-age children are therefore     recommended by the World Health Organization (WHO). WHO also recommends deworming of     preschool-age children (as of 12 months of age) in these areas; however, the benefits of     deworming, especially in the 12-24 month age group, have been inadequately studied. This     knowledge is urgently needed as studies show that all children have a similar potential for     healthy growth and development, provided that appropriate nutrition and health interventions     are given in the critical window of opportunity before the age of two.      Therefore, the investigators are proposing to undertake a randomized controlled trial to     determine the effect of deworming program for improving growth and development in children     between 12 and 24 months of age. Our results will provide solid rigorous evidence on if,     when, and how often, deworming should be integrated into routine child health care packages     provided by Ministries of Health in the 130 countries in the world where worm infections are     endemic.   "
150434|NCT01314924|"     We aimed to identify clinical and vascular parameters of treated hypertensive patients who     present beneficial effects of dark chocolate for one-week period on vascular function.   "
150435|NCT01314911|"     People who are infected with the influenza virus may develop respiratory illnesses, such as     pneumonia, or other life-threatening complications. Currently, there are four antiviral     medications that are used to treat influenza. This study will examine one of these     medications, oseltamivir, to examine how it affects the shedding of influenza virus in     infected people.   "
150436|NCT01314898|"     24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid     activity. The dose-response relationship of the antimineralocorticoid activity of PF-03882845     can be established following single oral doses.   "
150423|NCT01315067|"     Reliable and timely detection of acute rejections in renal transplant patients is important     to preserve the graft function and to prevent premature graft failure. The current gold     standard for the rejection diagnosis is a renal biopsy which is usually performed upon an     unexplained decline in the graft function (determined by serum creatinine or clearance).     Because of the insensitivity of creatinine determinations and the invasiveness of renal     biopsies, non-invasive tests have been suggested to diagnose acute rejection including mass     spectrometry (MS) analysis of urine samples.      The ability of MS analysis to detect acute rejection has been demonstrated in small studies     on selected patients but evidence is lacking that this test is efficacious in the routine     setting of the post-transplant patient care. Based on our previous work that established     urine peptide sets for acute rejection by MS, a prospective, multicentre diagnostic phase III     study will be executed.      The aim of the study is to prove that this test is as equally effective as the allograft     biopsy to detect acute rejection in patients that undergo a biopsy for unexplained renal     dysfunction. The perspective of this approach is that the test could be used either in place     of the biopsy or as decision guidance whether a biopsy is necessary to confirm the presence     of rejection. Another perspective is that the MS test (respectively, a simplified test system     derived from this method) could be used in the regular post-transplant surveillance for acute     rejection, in place of the relatively insensitive procedure with periodic monitoring of the     graft function by creatinine determinations.   "
150424|NCT01315054|"     Methadone treatment has became one of main actions taken in China to control the spread of     HIV among drug users. However，the average methadone dose used is relatively low. An intensive     methadone maintenance treatment (MMT) provider training on methadone dosage may be effective     in increasing the methadone dose levels prescribed to new patients. The study will evaluate     the effectiveness of a tailored education program for MMT service providers using subsequent     methadone dose prescribed to new patients. The effects of methadone dose, with and without     the inclusion of additional psychosocial services, will then be measured through MMT     retention and illicit opioid use.   "
150425|NCT01315041|"     Hot flushes are common symptoms in women after menopause, and are important causes of     discomfort and lead to high number of medical consultations. Hormone replacement therapy is     an effective treatment, however it can bring undesirable consequences and may be     contraindicated for some women. Options are inhibitors of serotonin or     serotonin-norepinephrine reuptake, gabapentin, herbal medicines and homeopathy. None of these     therapies is widely accepted of effective. Therefore, the search for new therapeutic options     is highly desirable. Ingestion of malagueta pepper fruits (Capsicum frutescens L. var.     malagueta) causes sensations similar to those experienced by menopausal women during hot     flushes. By the principle of homeopathy, the like cures the like, the objectives of this     study are: (a) to determinate whether pathogenesis of a homeopathic medicine made from C.     frutescens fruits include symptoms like hot flushes, and (b) whether this medicine is     effective on hot flushes relief in women after menopause. There will be 2 distinct phases.     Phase 1 is the determination of the medicine's pathogenesis in healthy volunteers, in a     randomized placebo-controlled, double-blind design. Phase 2 is the investigation of the     medicine's effects on hot flushes of women after menopause, in a randomized     placebo-controlled, double-blind design. The investigators expect a significant reduction on     symptoms perception, assessed by internationally validated tools. The study is expected to     last for 18 months, with 36 patients included in each phase.   "
150426|NCT01315028|"     There is a need to develop a better understanding of the early phase of bipolar disorder, and     to develop and evaluate effective psychosocial interventions that assist people in this     phase. The purpose of this study is to determine whether or not it is feasible to conduct a     larger study of the effectiveness of cognitive interpersonal therapy (a psychological     therapy) with individuals who have experienced their first or second treated episode of mania     or hypomania (symptoms common in early development of bipolar disorders).   "
150427|NCT01315015|"     The purpose of this study is to determine the cost-effectiveness of biennial screening with     mammography and MRI compared to mammography alone in women aged 50-75 years and who show >     75% mammographic density.   "
150428|NCT01315002|"     The purpose of this study is to test the effects of nicotine on cognition with the following     schizophrenia endophenotypes: prepulse inhibition, antisaccades, the continuous performance     test, spatial working memory and a verbal memory task. Schizophrenia patients, unaffected     first-degree relatives of schizophrenia patients and healthy controls receive transdermal     nicotine in a double-blind, placebo-controlled, crossover study.   "
150429|NCT01314989|"     Cyproheptadine is currently clinically used as an appetite stimulant for children with     failure to thrive without underlying organic disease. Otherwise, no randomised control trial     demonstrates the efficacy of Cyproheptadine on those patients. This is precisely what the     investigators intend to demonstrate on this randomised placebo control cross-over trial. Our     hypothesis is that Cyproheptadine is more efficient than placebo to improve weight gain and     feeding behaviour on 2 to 4 years old children with failure to thrive.   "
150430|NCT01314976|"     Introduction: Dientamoeba fragilis (DF) is a commonly occurring intestinal protozoan that is     considered a possible cause of infectious gastrointestinal disease in adults and children. DF     has a particular high prevalence in children, and it is suspected that children present more     symptoms in infection than adults. However, evidence of causality is lacking, treatment     regimens are largely untested in controlled trials, and the most commonly used antibiotic     against DF in Denmark, metronidazole, has never been tested against placebo.      Main objective: To determine the clinical effect of metronidazole in DF-infected children     with gastrointestinal complaints, where no other aetiology is known and no other     gastrointestinal pathogens could be shown.   "
150431|NCT01314963|"     Lymphoscintigraphy is an accepted and commonly performed procedure used for staging of     certain cancers, especially melanoma and breast cancer. It involves injecting a small amount     of radioactivity under the skin in order to identify lymph nodes which should be biopsied     (i.e., the sentinel node) to determine if cancer has spread. Our objective is to evaluate     the potential benefit of a new, camera-based technology which allows actual images to be     obtained intraoperatively in the identification of sentinel nodes.   "
150586|NCT01312857|"     The purpose of this study is to see if Panitumumab plus the other treatments will increase     the time of remission. Remission means that there is no sign of the cancer.   "
150438|NCT01314872|"     This is a 2-part study to assess if vibegron (MK-4618) reduces the number of daily urinations     more effectively than placebo in participants with overactive bladder (OAB). The primary     hypothesis of the base study is that administration of vibegron demonstrates a dose-related     reduction, compared with placebo, in average number of daily micturitions in participants     with OAB after 8 weeks of treatment.   "
150439|NCT01314859|"     This is a study for pregnant women who have been diagnosed with Threatened Preterm Labor. The     principal aim of this study is to compare the efficacy and safety of Nifedipine treatment     versus Atosiban treatment over these patients' newborn babies.   "
150440|NCT01314846|"     Fertilization and embryo development in vivo occurs in appropriate conditions in the     mammalian reproductive tract. However in assisted reproductive technology (ART) embryos and     oocytes are exposed to certain factors such as temperature, O2 pressure and pH fluctuations     that may affect embryo development and viability in vitro. In Preimplantation Genetic     Screening program (PGS) the investigators need to culture the embryos until day 5 so the     requirement of culture techniques must be optimal to produce acceptable blastocyst rates. As     it has been shown before, embryo culture conditions have the potential to impact biopsied     embryos and hence PGS success rates.      Nowadays the coculture system with endometrial cells could be an alternative option to     improve the blastocyst rates since some publications have indicated that endometrial cells     may provide trace elements and growth factors that are not present in defined culture media     and reproduce physiologic conditions. Although the role of coculture in vitro fertilization     (IVF) has been controversial, a recent meta-analysis has established the potential benefits     of coculture system.      The aim of this study was to compare embryologic and clinical outcomes in terms of     blastocyst, implantation and pregnancy rates to evaluate endometrial epithelial cell (EEC)     coculture versus sequential culture system in advanced maternal age ( ≥39 years) in the PGS     program.   "
150441|NCT01314833|"     In recent years, the increasing number of breast cancer patients shows the fact breast cancer     is one of the most common cancers in women in China. However, the mortality rate has seen a     dramatic decline mainly due to early detection of breast cancer and the use of effective     multimodel treatment. Recent studies suggest breast cancers are heterogeneous and recognized     by biological subtypes, which lead to markedly different clinical outcome.      Adjuvant chemotherapy is widely used in the treatment for primary breast cancer patients.     Different types of breast cancer cells are sensitive to different types of drugs.There is no     data to support the information about the adjuvant chemotherapy regimens for different     subtypes breast cancer patients， especially for Chinese women.      The investigators hypothesized to confirm the possibility of finding the adjuvant     chemotherapy aimed to different subtypes of breast cancer.   "
150442|NCT01314820|"     The present study investigated whether the presence of fluid in the joint affected peak     torque and the root mean square (RMS) values of surface electromyography (EMG) in patients     symptomatic for osteoarthritis (OA).   "
150443|NCT01314807|"     The aim of this prospective case-control study is to investigate the prevalence, severity and     incidence of systemic consequences in newly detected patients with mild and moderate Chronic     obstructive pulmonary disease (COPD). Special attention will be paid to skeletal muscle     dysfunction and physical inactivity as these factors are, together with smoking, potentially     modifiable.   "
150444|NCT01314781|"     The aim of the present study is to investigate in patients with overactive bladder syndrome     (OABS) whether a combination treatment of solifenacin with pelvic floor muscle training and     whole body vibration training achieves a better treatment outcome than a treatment with     solifenacin alone.   "
150445|NCT01314768|"     The investigators will perform a cluster randomised controlled study of Brief intervention     (BI) for medication-overuse headache (MOH) versus business as usual. GPs will be trained to     perform a structured brief intervention after identifying patients with probable MOH using     the severity of dependence scale. The control arm will include patients of GPs who have not     been trained in BI. Patients will be recruited by prior short postal screening of patients     listed on the GPs patient lists.      The hypothesis is that BI will lead to improvement of medication-overuse and chronic headache     as compared to no BI.      Main outcomes are:        -  number of medication days per month        -  number of headache days per month        -  headache index   "
150446|NCT01314755|"     Study Hypothesis: The peri-operative enteral administration of a proprietary immune-enhancing     feed (IMPACT) will not reduce post-operative infective complications in patients undergoing     major surgery for squamous cell carcinoma of the Head and neck (SCCHN).      Patients who present with SCCHN for whom surgery is the recommended treatment will, assuming     they fulfill the eligibility criteria, be block randomised into a two-group, double-blind     randomised controlled trial. One group will receive IMPACT, the other an iso-caloric,     iso-nitrogenous control feed for 5 days pre and 7 days post-operatively. In both groups     patients will be fed enterally. The feeds will be prepared in identical bottles to facilitate     blinding. Primary outcome measures include major systemic infection, whilst secondary outcome     measures include local infection and length of hospital stay. Follow-up will be for 30 days     postsurgery.   "
150447|NCT01314742|"     The goal of this pilot study is to test the hypothesis that mechanically ventilated infants     receiving Biotene OralBalance® gel for oral care would have a reduced intubation time     compared to infants receiving oral care placebo. This study is also performed to test the     feasibility as well the safety of Biotene OralBalance® gel.   "
150448|NCT01314729|"     Different types of retainers have been used to assure the stability of orthodontic treatment.     The aim of this study is clinical and radiographic comparison and evaluation of two common     types of lingual fixed retainers on the health of periodontium.      The participants in this study will be examined both clinically and radiographically just     after the completion of orthodontic treatment and after a 6-month-period.      The results of the study will be analyzed with Mann-whitney and independent t-test.   "
150449|NCT01314716|"     The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and     gram-negative airway infection. Participants received two 28-day courses of either Aztreonam     for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a     28-day off-drug period. Following the two blinded courses, all participants received a 28-day     course of open-label AZLI then were followed for an additional 56 days.   "
150450|NCT01314703|"     The primary objective of this study is to measure the antimicrobial effectiveness of     ChloraPrep one-Step.   "
150451|NCT01314690|"     The objectives of this study are: 1-To qualify the relationship between the gut microbiota     and the host nutritional and metabolic status during dietary transition.2-To define the     impact of nutritional transition on the intestinal microbiota and identify metagenomics     signatures of nutritional transition.   "
150452|NCT01314677|"     This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography     (PET)/computed tomography (CT) in predicting chemoradiation therapy (CRT) failure in patients     with stage IIIA non-small cell lung cancer (NSCLC). Diagnostic procedures, such as FDG     PET/CT, may help predict CRT failure. Comparing diagnostic results during CRT may help     doctors predict a patient's response to treatment and help plan the best treatment   "
150453|NCT01314664|"     The purpose of this study is to observe and describe the effectiveness and local tolerability     of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a     cohort of subjects treated under routine practice conditions.   "
150454|NCT01314651|"     The purpose of this study is to test the efficacy of a brief behavioral insomnia intervention     in reducing headache frequency and severity among patients with chronic migraine and     insomnia. It is hypothesized that this intervention will produce greater changes in headache     frequency and severity than will a comparison treatment involving non-sleep-specific general     lifestyle modifications.   "
150455|NCT01314638|"     The purpose of this study is to measure the adherence to Siel bleu balance exercises in     patients with Alzheimer's disease, while taking into account the disease stages.   "
150456|NCT01314625|"     The purpose of this study is to determine whether the orthostatic hypotension reported among     subjects during bortezomib-containing regimen is caused by a dysfunction of the autonomic     nervous system (ANS).   "
150457|NCT01314612|"     Many combat Veterans suffer from posttraumatic stress disorder (PTSD), an anxiety disorder     that develops after an extremely stressful event or events. PTSD is associated with problems     falling asleep or staying asleep. Veterans with PTSD also commonly have nightmares from     stressful experiences. These symptoms can cause problems in daily life. Behavioral treatments     that do not involve taking medication have been shown to help improve problems related to     sleep and nightmares. However, very few of these treatments address both sleep problems and     nightmares at the same time, even though many people suffer from both problems. The purpose     of this study is to examine the effectiveness of a combined treatment for sleep problems and     nightmares in Veterans suffering from combat-related PTSD that is presented in a group     format. The investigators hypothesize that the completion of this treatment will lead to     increases in sleep quality and decreases in the frequency and severity of nightmares as     measured by standard questionnaires.   "
150458|NCT01314599|"     Phase I Study of PM01183 in Patients with Advanced Acute Leukemia to determine the maximum     tolerated dose (MTD) and the recommended dose (RD) of PM01183.   "
150459|NCT01314586|"     Purpose: To demonstrate the efficacy of Beneflax™ flaxseed lignan (SDG) concentrate to lower     serum cholesterol levels.      Background: Flaxseed has been studied for various health benefits in humans, including     prostate health, glucose control, and cardiovascular health. Cholesterol levels and high     blood pressure are known to be risk factors for cardiovascular disease. Whole flaxseed has     had variable effects on serum lipid levels, perhaps a consequence of variations in the     amounts of secoisolariciresinol diglucoside (SDG) found in different flax cultivars, making     the study of this bioactive compound difficult.      Hypothesis: Flaxseed lignan (SDG) extract (Beneflax) significantly lowers total and LDL     cholesterol. Flaxseed lignans also lower blood pressure and fasting glucose levels.   "
150460|NCT01314573|"     The purpose of the study is to examine the effects of different exercise intensity training     programs upon blood vessel function and circulating blood cells involved in blood vessel     repair in young women. The long term effects of exercise may be beneficial to cardiovascular     health and it is important to understand the training methods that are the most beneficial.     In particular we aim to determine if brief maximal exercise improves the function and     stiffness of blood vessels and enhance blood vessel repair. Two methods of exercising are     being compared, exercise bouts involving intermittent exercise and exercise completed all at     once, but at a very high intensity.   "
150461|NCT01314560|"     Lowe syndrome is associated with mutations in the OCRL1 gene, which encodes OCRL1, a     phosphatidylinositol-4, 5-bisphosphate (PtdIns(4, 5)P (2))5-phosphatase. PtdIns(4, 5)P2, a     substrate of OCRL1, is an important signaling molecule within the cell. An abnormal rate of     hemorrhagic events was found in a retrospective clinical survey, suggesting platelet     dysfunction.      The main objective of the study is to confirm the presence of platelet dysfunction in Lowe     syndrome and to characterize this abnormality.   "
150462|NCT01314547|"     Susceptibility to SPA has been shown to be largely genetically determined. The objective of     this study was to prospectively investigate the impact of several environmental factors on     disease activity.   "
150463|NCT01314534|"     Create a census for the duration of the search for French patients with SK        -  determining epidemiological and morphological parameters,        -  determine the true frequency of clinical symptoms and identify new ones,        -  identify complications of the disease to improve the care of patients in the hope of a          better prognosis of the disease and        -  performing a radiological study by Voxel based morphometry MRI type (N. BODDAERT,          HOPITAL Necker-Enfants Malades, Paris)      Perform genetic research to identify the genetic bases of SK using CGH-array (Comparative     Genomic Hybridization )   "
150464|NCT01314521|"     The purpose of this study is to examine clinical characteristics of Korean adolescents with     depression who have suicidal ideation and behavior. We formulate those hypotheses.        1. Being bullied in peer relationships, excessive use of internet, excessive          extra-curricular tutoring, sexual abuse in childhood, physical abuse and emotional          neglect are risk factors of suicide in adolescents.        2. Depression of parents and negative child-rearing attitude are risk factors of suicidal          ideation and behavior in adolescents.        3. Emotional quotient (EQ) and resilience of adolescent are protective factors of suicide.   "
150591|NCT01312792|"     The investigators Study Hypothesis is introduction of modified IMCI guideline for managing     severe pneumonia in first level health facilities will result in 40% increase in the     appropriate management (appropriate case management at the first level facility and referral     compliance by the caregivers) of severe pneumonia cases in the intervention arm compared to     the comparison arm.   "
150465|NCT01314508|"     A major consequence of chronic liver disease in childhood is growth failure. This is because     a chemical essential for growth called growth factor is created in the liver. Lack of     response to growth hormone in people with chronic liver disease is characterized by high     levels of growth hormone and low levels of growth factors. This growth hormone resistance is     reflected in a variety of factors including insulin resistance and low nutritional intake.     Unfortunately, growth hormone therapy has no effect for children with liver disease. In     addition, failure of normal growth or malnutrition makes liver disease even worse in     children, and growth hormone therapy is not likely to reverse this. A lack of proper     nutrition is associated with hospitalizations and frequent complications. Poor growth is a     predictor of poor outcomes after liver transplantation. Thus the management of children with     liver disease remains a challenge. Children who have successful orthotopic liver transplants     (OLT) show much improvement in some aspects of growth, including skin fold thickness, mid-arm     circumference, and normalization of growth factor levels. However, some studies have recently     reported that the growth of 15-20% of children remains poor even after a liver transplant.     This can be explained by persistent abnormalities in growth factors after transplant.      Growth factor was found to be a good tool for prognosis in patients with chronic liver     disease. Studies showed that patients with liver cirrhosis and growth factor levels below     normal values showed lower long-term survival rates compared with patients who had above     normal values. This suggests that growth factor can be a good predictor of survival and early     marker of poor liver function. In this case, aggressive feeding may modestly improve growth     factor levels leading to improved growth but it is unlikely that effects will be optimal. The     investigators propose that growth factor administration may have a positive effect that leads     to better growth which is a major predictor of good outcome. To date, no reports study the     use of growth factor in children with chronic liver disease. This study proposes to examine     the effect of growth factor therapy in childhood chronic liver disease.   "
150466|NCT01314495|"     Will Abatacept reduce priming of the hair follicle specific T cells and thereby reduce hair     follicle associated infiltration and improve hair growth.      This is a double blind placebo controlled study to test the safety and efficacy of Abatacept     in the treatment of 64 subjects diagnosed with alopecia totalis or alopecia universalis.     Subjects will be randomized 1:1 to the placebo or treatment arm and will receive 6 months of     treatment with the study medication or placebo, followed by a 6 month observational period.   "
150467|NCT01314482|"     In about half the patients who have an open chest surgery there is persistent severe pain in     the chest. The investigators are examining whether minocycline, a commonly used antibiotic,     will prevent pain. Minocycline blocks the activity of immune cells which the investigators     believe are responsible for prolonging the pain.   "
150468|NCT01314469|"     The aim of this study is to determine if macular edema is associated with less visual     function and quality of live in patients with intermediate uveitis   "
150469|NCT01314456|"     Prostate biopsy is performed by multiple consecutive biopsy needle insertion into the     prostate gland under a trans-rectal ultrasound probe guidance.      Today, the performing physician navigates the needle using a momentary 2D ultrasound image     (longitudinal and transverse B mode) without any record of the full prostate boundaries or     previous biopsies' location.      This study's Objectives are to record the trans-rectal biopsy procedure including the initial     scan and the needle biopsy location and to modulate a 3D model of the prostate with accurate     display the locations of the various biopsies taken during the procedure.   "
150470|NCT01314443|"     Cigarette smoking is a significant risk factor for cardiovascular disease (CVD) and is the     leading cause of premature mortality in the US. The detrimental effects of smoking on     vascular dysfunction are attributed to the effects of smoke itself and the inflammatory     responses it induces. Smoking cessation restores vascular function by alleviating these     stress responses. However, smoking cessation with nicotine replacement therapy (NRT), the     prevailing approach to mitigate tobacco dependence, fails to allow full restoration of     vascular function. Thus, a critical public health problem exists to understand how NRT     prevents restoration of vascular function and how these NRT-mediated impairments can be     overcome by using gamma-tocopherol (g-T) as an innovative co-therapy. The objective of this     study is to conduct a clinical intervention trial that aims to reduce CVD risk by defining     how smoking cessation and g-T restore vascular function. The hypothesis is that smoking     cessation and dietary g-T supplementation will synergistically restore smoking-induced     impairments in vascular function by ameliorating oxidative/nitrosative stress responses, and     that g-T will facilitate full restoration of vascular function otherwise precluded by NRT. A     placebo-controlled, g-T intervention study will be conducted in cigarette smokers undergoing     nicotine-free or NRT smoking cessation. Prior to and after 24 h and 7 days of placebo or g-T     administration, vascular function will be evaluated using a non-invasive ultrasound technique     and an array of antioxidants and biomarkers for vascular inflammation and     oxidative/nitrosative stress responses will be assessed. Collectively, these studies will     help identify how vascular function is regulated in individuals undergoing smoking cessation,     and whether g-T can be used as a strategy to better improve vascular function during smoking     cessation.   "
150471|NCT01314417|"     BACKGROUND:      Uveitis comprises of a group of diseases associated with inflammation of the eye that can     lead to vision loss. Some people with uveitis also have macular edema (swelling of the retina     at the back of the eye). Uveitis and macular edema are treated with medications and sometimes     surgery, but treatment does not always prevent vision loss. Previous research has shown that     injections of methotrexate into the eye of people with eye disease other than uveitis can     help relieve the inflammation, or swelling, that causes macular edema and can slow visual     loss. However, it has not yet been approved as a treatment for macular edema associated with     uveitis.      OBJECTIVES:      To evaluate the safety and effectiveness of methotrexate injections as a treatment for     macular edema associated with uveitis.      ELIGIBILITY:      Individuals at least 18 years of age who have been diagnosed with uveitis and macular edema     in at least one eye.      DESIGN:        -  This study requires at least nine visits to the National Eye Institute study clinic over          a period of 6 months (24 weeks).        -  Participants will be screened with a physical and ophthalmic examination, medical          history, blood and urine tests, and additional eye and other tests as needed.        -  Participants will receive a methotrexate injection in a selected treatment eye. After          the injection, participants will receive antibiotic eye drops to place in the eye three          times a day for the 3 days following the injection, leucovorin (folic acid) drops to          place in the eye four times a day for 1 week following the injection, and a dose of          folic acid to be taken by mouth the day after the injection.        -  Participants who tolerate the initial injection may continue to receive injections in          their study eye every month for 6 months. After 6 months, participants who show          improvement from the injections may be evaluated to receive additional injections every          4 to 8 weeks until researchers end the study.   "
150472|NCT01314404|"     The Global Alliance to Immunize Against AIDS Vaccine Foundation (GAIA Vaccine Foundation or     GAIA VF) proposes to carry out a Knowledge, Attitudes, and Practices (KAP) study in     conjunction with a Willingness To Participate (WTP) evaluation to establish the prevalence of     cervical dysplasia, to and perform Human Papillomavirus (HPV) subtyping studies in Bamako and     in Sikoro-Mekin, a village within the perimeter of Bamako, the capital of Mali, West Africa.     Working with experienced collaborators, we propose to carry out an HPV prevalence study     (among women diagnosed with cervical cancer at Hôpital Touré), coupled with a study of     Knowledge, Attitudes and Practices (KAP) and Willingness To Participate (WTP) in an HPV     vaccine study among individuals living in Sikoro-Mekin. These studies will lay the groundwork     for a phase IV study of Gardasil® at the same site, which would be an important step forward     for West Africa.   "
151167|NCT01305161|"     To assess diagnostic accuracy of flow cytometry applied to the diagnosis of allergy to     neuro-muscular blockers and to the determination of the neuro-muscular blocker (NMB) which     may be used for an ulterior anaesthesia in case of allergy to one given NMB.   "
150473|NCT01314391|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This research study is studying biomarkers in blood and tumor tissue samples from     patients with Wilms tumor.   "
150592|NCT01312779|"     The purpose of this clinical study is to obtain human clinical data that demonstrates that     the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is     a safe and effective replacement heart valve.   "
150474|NCT01314378|"     Dependence on tobacco derived nicotine is a major public health problem. Substance users who     complete training in mindfulness subjectively report increased patience and improved motor     control over their impulses. Yet, no studies have tested this perceived benefit with     behavioral measures of impulse control. The investigators are conducting a randomized     controlled clinical trial, which compares Cognitive-Behavioral Therapy and Mindfulness     Training for tobacco smokers, using behavioral measures to investigate the effects of     mindfulness training on impulsivity and inhibitory control.   "
150475|NCT01314365|"     The purpose of the protocol is to determine typical patient response to Dysport in the     treatment of adult cervical dystonia (CD).   "
150476|NCT01314352|"     The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's     Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fed     conditions.   "
150477|NCT01314339|"     The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's     Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fasting     conditions.   "
150478|NCT01314326|"     The specific aims of the clinical studies are to:        1. Predict the development of glaucomatous visual field (VF) abnormality in glaucoma          suspects and pre-perimetric glaucoma patients based on anatomic abnormalities detected          by advanced imaging.        2. Predict the development of glaucomatous VF abnormality in glaucoma suspects and          pre-perimetric glaucoma patients based on anatomic changes detected between successive          advanced imaging tests.        3. Determine the sensitivity and specificity of glaucoma diagnosis based on advanced          imaging tests.   "
150479|NCT01314313|"     The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN     XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended     for use in patients with symptomatic, calcific, severe aortic stenosis.   "
150480|NCT01314300|"     Lidocaine 5% plaster (VERSATIS® 5%) showed its efficacy and safety in the post-herpetic     zoster adult pains. This treatment is recommended in first intention in adult neuropathic     pains with allodynia.      The purpose of this study is to assess efficacy and safety of lidocaine 5% plaster (VERSATIS®     5%) in the pediatric neuropathic pains and vasoocclusive sickle cell crises pains.   "
150481|NCT01314287|"     General anaesthesia causes small areas of lung to collapse (referred to as atelectasis) and     many strategies are used to prevent or reverse this, but these strategies only temporarily     improve lung function and do not persist into the post anaesthesia care unit (PACU) where     atelectasis may still be present. One possible explanation for this is that coughing     occurring at the end of the anaesthesic may cause atelectasis to occur. Over 70% of patients     cough when their breathing tube is removed as they emerge from the anaesthetic, and our     hypothesis is that the presence of the breathing tube prevents a normal cough from occurring     and may worsen atelectasis. This study will use alveolar-arterial oxygen difference (AaDO2)as     a measure of how well the lungs are oxygenating the blood. This will be measured 30 minutes     before the end of the anaesthetic as a control measure of the patient's lung function, and     again 60 minutes after the patient has woken up, and the change compared with the amount of     coughing observed as the patient emerges from the anaesthetic.   "
150482|NCT01314274|"     In a case series intranasal submucosal bevacizumab has been shown to reduce epistaxis in     patients suffering from Hereditary Haemorrhagic Telangiectasia together with KTP Laser     therapy. The aim of this study is to evaluate the effectiveness of submucosal intranasal     bevacizumab compared to placebo in a randomized double blind trial setting.   "
150483|NCT01314261|"     The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid     virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in     combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone     (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected     participants.   "
150484|NCT01314248|"     The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway     maintenance during routine anesthesia and as a conduit for tracheal intubation for patients     with a difficult airway. The investigators goal for this study is to compare the performance     of the ILA with the current standard of care the standard LMA during routine anesthesia.   "
150485|NCT01314235|"     Clonidin works as a presynaptic agonist of alpha-sympathomimetic receptors of the brain but     also in many other tissues. It is part of balanced anesthesia in general anesthesiology as     well as a sedastive agent in intensive care units, but also serves as a third-line agent in     many psychiatric diseases including ADHD, schizophrenia and PTSD.      The investigators want to show whether clonidin has an procoagulatoric effect on thrombozytes     of patients under double anticoagulaotirc treatment with ASS and clopidogrel. The     investigators will use a flowcytometric assay to determine activation of thrombozytes when     they come into contact with clonidine in vitro as well as Multiplate analyses to determine     activation of thrombozytes, either thrombin.induced aggregation, ADP-induced aggregation or     arachidonic acid-induced aggregation of thrombozytes.   "
150486|NCT01314222|"     The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared     to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).   "
150487|NCT01314209|"     The purpose of this study is to determine dexmedetomidine pharmacokinetics during continuous     renal replacement therapy on critically ill patients.   "
150587|NCT01312844|"     The primary purpose of this study is to assess the ability of scopolamine to improve the     antidepressant effects of ECT and to determine whether scopolamine will shorten the time to     response and remission for patients receiving ECT.      The hypothesis are:        1. Patients receiving ECT plus scopolamine will have greater improvement in depression          symptoms than those receiving ECT plus placebo.        2. Patients receiving scopolamine in addition to ECT will require fewer ECT treatments to          obtain response/remission compared to the group receiving ECT plus placebo.        3. Time to response and to remission in the scopolamine group will be significantly shorter          compared to ECT alone.   "
150593|NCT01312766|"     The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety     of two different subcutaneous hMG preparations when administered to patients undergoing     controlled ovarian stimulation for IVF.   "
152922|NCT01282138|"     The purpose of this study was to evaluate ocular responses with different allergen     provocation methods.   "
150488|NCT01314196|"     The aim of this study was to evaluate the influence of progressive resistance training of the     biceps in shoulder rehabilitation in patients with subacromial impingement syndrome (SIS).      Method: a randomized controlled clinical trial, with analysis intention-to-treat, approved by     the Ethics and Research (1019/08), containing sixty patients of both sexes, SIS, evaluated at     the initial time (T0), with 45 days (T45) and 90 days of treatment (T90). We analyzed the     pain at rest (VAS), range of shoulder movement, strength, function by The Disabilities of     Arm, Shoulder and Hand (DASH) and quality of life by Short Form-36 (SF-36) and Western     Ontario Rotator Cuff Index (WORC). They recommended the use of NSAIDs and analgesics in the     presence of pain exacerbated, every eight hours. Study groups will perform therapeutic     exercises for the shoulder and scapula stabilizers. In the experimental group associate     progressive resistance training of the biceps.   "
150489|NCT01314183|"     The overall aim of the project is to examine the clinical and cost-effectiveness of utilizing     booster sessions(periodic face-to-face follow-up appointments that take place several weeks     or months following discharge from the supervised therapy program designed to review the     patient's current rehabilitation program, troubleshoot any problems with the program, and     make recommendations for program progression or modification) in the delivery of exercise     therapy, and supplementing exercise therapy with manual therapy techniques(manually applied     treatment techniques such as joint mobilization/manipulation, manual traction, soft tissue     manipulations, passive stretching and range of motion). The investigators will do this in a     randomized, multi-center, clinical trial. The investigators hypothesize that adding manual     therapy techniques will be more clinically effective than exercise alone and that using     booster sessions will maintain longer term clinical effects and be more cost-effective than     not using booster sessions.   "
150490|NCT01314170|"     Study clinical multicenter, phase III, open-label, prospective character to evaluate the     efficacy and safety Susanna Implant in patients with refractory glaucoma.   "
150491|NCT01314157|"     Isostretching is effective in treating chronic back pain to improve pain, quality of life and     functional capacity.   "
150492|NCT01314144|"     Axillary clearance forms part of the surgical armamentarium for the treatment of breast     cancer. Although the introduction of sentinel lymph node mapping and dissection has allowed     for the decreased use of axillary clearance, it remains a frequently performed operation.     Axillary clearance is associated with moderate postoperative pain.      We hypothesize that a continuous wound infusion of 0.2% Bupivacaine at 4ml/hr would provide     superior analgesia, when compared to standard opioid-based analgesia, in patients undergoing     axillary lymph node clearance surgery.   "
150493|NCT01314131|"     The purpose is to evaluate patients' interests (patients in nursing home). Moreover the study     aims to evaluate whether an activity for which the patient is interested in, allows a better     involvement and stimulation.   "
150494|NCT01314118|"     The purpose of this study is to show that abiraterone acetate plus prednisone added to the     current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific     antigen (PSA) and prolongs the time until it is evident that the cancer has grown.     Additionally, safety information about abiraterone acetate in combination with prednisone     will be collected. This will include looking at what side effects occur, how often they     occur, and for how long they last.   "
150495|NCT01314105|"     This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to     treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in     patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma     or primary peritoneal cancer.   "
150496|NCT01314092|"     Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into     myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal     fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown     efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the     investigators would apply autologous adipose stem cells on complex perianal fistula to     evaluate their efficacy and safety.   "
150497|NCT01314079|"     This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of     Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical     trial.   "
150498|NCT01314066|"     This study aims to test the effectiveness of a single intravenous (IV, through the vein) dose     of the study drug, bevacizumab (Avastin), in preventing/reducing the development of Acute     Respiratory Distress Syndrome (ARDS), in patients with severe sepsis, who are at high risk     for developing ARDS. ARDS is a lung disease caused by a lung injury that leads to lung     function impairment. The condition the patient has,severe sepsis, is a medical condition     associated with an infection characterized as an immune system inflammatory response     throughout your whole body that can lead to organ dysfunction, low blood pressure or     insufficient blood flow to one or more of your organs.   "
150499|NCT01314053|"     Daptomycin was approved since 2005 in Taiwan and have been studied and published in west     countries. After review the published papers, the few data were described in the Asian     countries or Taiwan. The objectives of this study are to evaluate the efficacy and safety of     daptomycin for the treatment of Gram-positive infections under actual conditions of use, and     to understand other information concerned with daptomycin prescription. This study represents     an opportunity for acquiring real world data on daptomycin usage, and may provide physicians     in Taiwan with the information of characteristic of the patients receiving daptomycin and to     evaluate outcomes. It also provides a means to identify safety signals that emerge with     clinical usage.   "
150500|NCT01314040|"     Results from observational studies suggest a small beneficial association between protein and     blood pressure that may be mainly attributable to the intake of protein from plant sources.     In epidemiological studies biomarkers of dietary intake are useful to estimate intake more     reliably. Dietary studies using biomarkers of protein intake generally show stronger     associations with health outcomes. However, data on biomarkers for specific types of protein     (e.g. from dairy, meat, grain and legumes) are scarce. Therefore the purpose of this study is     to identify new biomarkers for the intake of protein from meat, dairy and grain. In addition     the secondary purpose is to investigate whether intake of protein from these sources     influences kidney filtration rate and urinary acid excretion differentially.   "
155800|NCT01244529|"     The purpose of this study is to evaluate the comparability of lens fit and lens power of a     new contact lens to the lens fit and lens power of two marketed lenses.   "
150501|NCT01314027|"     The outcome of patients with resected pancreatic cancer has significantly been improved by     adjuvant chemotherapy. However, a large proportion of patients cannot receive adjuvant     chemotherapy due to surgical complications. Neoadjuvant chemotherapy has been shown to be     safe and effective and can be applied to all patients. This study should test neoadjuvant     chemotherapy in a randomized manner.      Patients with resectable cytologically proven adenocarinoma of the pancreatic head are     randomized to arm A or B.      Patients randomized to arm A receive an 8-week neoadjuvant chemotherapy with     gemcitabine/oxaliplatin followed by surgery. Thereafter, all patients receive adjuvant     gemcitabine for six months.      Patients randomized to arm B undergo surgery and receive the same adjuvant treatment as in     arm A.      The primary study-endpoint is the recurrence-free survival. Tumor recurrence are determined     by computed tomography in a defined protocol.        -  Trial with medicinal product   "
150502|NCT01314014|"     The purpose of this study is to determine whether Amplimexon (imexon for injection) is     effective in the treatment of indolent and aggressive lymphomas that have progressed after     treatment with standard therapies.   "
150503|NCT01314001|"     The purpose of this research program is to understand how a biomarker called the nicotine     metabolite ratio (also referred to as NMR) may influence a smoker's ability to quit smoking.   "
150504|NCT01313988|"     Plant sterols and fish fatty acids are known to affect the blood lipid profile. This     randomized, double-blind, placebo-controlled, parallel efficacy study is designed to     investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of     plant sterols and different doses of fish fatty acids when combined in a spread format.   "
150505|NCT01313975|"     During the course of their acute illness patients with subarachnoid hemorrhage and severe     traumatic brain injury often develop disturbances in their fluid balance and electrolyte     homeostasis. These shifts are associated with worse outcome and increased morbidity.      The aim of this observational study is to systematically analyze the incidence,     characteristics, potential diagnostic markers and predisposing factors of such disturbances.     The investigators hypothesize that many disturbances cannot be classified with a standard     diagnostic approach and that variable fluid management contributes to their pathophysiology.      Patients will be closely monitored clinically and the exact fluid and electrolyte balances     will be recorded. Treatment decisions are within the bedside physicians responsibility.     Baseline fluid management is standardised. No interventions are planned. The observation     period equal the duration of ICU stay.   "
150506|NCT01313962|"     The purpose of this study is to evaluate the safety and pharmacokinetic profile of     flufirvitide-3 nasal spray in healthy subjects.   "
150507|NCT01313949|"     The investigators hypothesize that a training course to people with diabetes on peer support     and empowerment will improve their glycemic parameters, knowledge on diabetes and level of     self efficacy. This group of trained patients (peer leaders) should be competent to teach and     help other patients with diabetes through peer support and empowerment on better self     management of their diabetes.   "
150508|NCT01313936|"     This is a pilot study to determine whether doses of 15 mCi/kg and 18 mCi/kg of 131I-MIBG are     tolerable when given with irinotecan/vincristine on a one week schedule to children and young     adults with high-risk refractory/relapsed neuroblastoma.   "
150509|NCT01313923|"     The purpose of this research is to study alternative treatments for the skin disease     pemphigus (a rare autoimmune blistering disorder of the skin) by using sirolimus, an     immunosuppressive drug. Immunosuppressive drugs inhibit or prevent the activity of the immune     system and are commonly used to treat autoimmune diseases, inflammatory diseases, and organ     transplantation rejection.   "
150510|NCT01313910|"     The purpose of the study is to see if ImmunoLin® will reduce the frequency of bowel movements     and gastrointestinal (GI) symptoms in HIV volunteers with persistent GI symptoms. The study     will also examine the effect of ImmunoLin® on the bacteria in the gut and the immune system     in gut tissue as well as in the blood.   "
150511|NCT01313897|"     The purpose of this study is to determine the therapeutic efficacy of the exp-NK cell therapy     in research participants with relapsed high risk MM [defined as gene expression profile (GEP)     70 gene score ≥0.66 and/or metaphase chromosomal abnormalities and/or high LDH ≥ 360U/L] by     establishing the (near) complete response rate. Response rate will be compared to case     matched historical controls (patients who relapsed on Total Therapy 2 or 3 with high-risk MM     defined as above). Disease-free survival and overall survival will be captured but are not     primary or secondary endpoints.   "
150512|NCT01313884|"     The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care     chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature     we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma     using Irinotecan and Temozolomide in addition to standard chemotherapy.   "
150513|NCT01313871|"     The study will assess the disease severity and treatment patterns of rheumatoid arthritis in     Eastern European, Middle Eastern, and North African countries.   "
150514|NCT01313858|"     This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid     arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to     evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice     conditions as assessed by the incidence and type of (serious) adverse events and changes in     clinical status of participants as assessed by clinical parameters.   "
150515|NCT01313845|"     A double-blinded randomized placebo-controlled trial of intravenous amantadine on gait     freezing refractory to oral anti-parkinsonian medications in patients with Parkinson's     disease.        -  administration of IV amantadine or normal saline for 5 days, 2 times a day while keeping          current oral anti-parkinsonian medications unchanged        -  follow-up after administration of IV amantadine for 4 weeks        -  allocation ratio of amantadine:normal saline is 2:1   "
150588|NCT01312831|"     The purpose of this study is to compare the efficacy and safety profile of a new oral vitamin     B12 formulation (Eligen® B12) with intramuscular B12 in restoring normal B12 (cobalamin)     concentrations in subjects with low cobalamin levels (<350 pg/mL).   "
150820|NCT01309815|"     The purpose is to describe, interpret and provide a detailed understanding of what it means     to be elderly people with cancer who receive treatment in specialized health care. Focus is     especially put on the content and expression of existential issues and the importance of     spirituality for the patient´s life story and medical story.   "
150516|NCT01313832|"     Intraoperative myocardial and pulmonary protection is important for better outcome after     cardiac surgery. Ischemic preconditioning is one of organ protective strategies against     ischemia-reperfusion injury by applying brief ischemia to the target organ before a     subsequent critical ischemia, and its effect has been confirmed. However, its clinical     application is not easy because ischemic insult may aggravate the function of vulnerable     organ.      On the other hand, remote ischemic preconditioning (RIPC) is another protective approach by     applying ischemia to other less vulnerable organ such as skeletal muscle before critical     ischemia-reperfusion injury to heart. The effect of RIPC has been well demonstrated in adults     and children. However, Little is known about the effect of remote ischemic precondition on     the pediatric myocardium to ischemia and reperfusion injury. The effect of RIPC on the     children remains to be further evaluated because the degree of ischemia-reperfusion injury is     different according to age, cardiac pathology and cyanosis. In addition, the previous report     on children dealt with a diverse range of congenital heart defects with a wide age range. The     purpose of this study was to evaluate the effect of RIPC on myocardial and pulmonary     protection in infants with pulmonary hypertension who need repair of simple ventricular     septal defect.   "
150517|NCT01313819|"     Tp determine the effect of IV amantadine on dopaminergic-drug-resistant freezing of     gait(FOG)in patients with Parkinson`s disease   "
150518|NCT01313806|"     To determine if low level magnetic fields can help to improve memory in patients diagnosed     with Alzheimer's disease.   "
150519|NCT01313793|"     The study will determine if bioequivalence can be claimed between the proposed     commericializable formulation and the current clinical formulation. Specifically, if the 90%     confidence intervals of the ratio for Area under the curve (AUC) and maximum concentration     (CMax) are within the 80%-125% guidance limits.   "
150520|NCT01313780|"     Objectives:      To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity        1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours          obtained each evening) within 4 weeks        2. Secondary objectives: Bowel Habit (worsening/no change/improving), Total dose and          frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need          of laxative use and Adverse events   "
150521|NCT01313767|"     This study is a randomized, double blind, multi-center, active drug controlled, phase III     clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of     post stroke upper limb(wrist, finger, thumb) spasticity      Approximately 196 subjects(1:1 group ratio)will be enrolled. Subjects will receive a single     treatment of intramuscular Investigational product up to 360U. The subjects will be observed     every 4 weeks until 12 weeks post injection. Outcome measures include Modified Ashworth Scale     (MAS), Disability Assessment Scale (DAS), Global Assessment Scale(patient or     caregiver/investigator) and Carer burden scale. The primary efficacy endpoint is the change     from baseline at week 4 for wrist flexor muscle tone as measured on the Modified Ashworth     Scale. Safety parameters will also be measured including adverse events, vital signs and     clinical laboratory tests (haematology, serum chemistry and urinanalysis).   "
150522|NCT01313754|"     The purpose of this study is to compare different skin closure materials for the     transobturator suburethral sling procedure. Currently the investigators are using monocryl     suture material as the standard for skin closure. This material has anecdotally show to be     very irritating to patients who have had this type of surgery. Our study will compare the     monocryl suture material with vicryl (polyglactin 910) and dermabond (2-octyl cyanoacrylate)     skin glue. The investigators believe that vicryl suture material will be superior in comfort     when compared to monocryl and dermabond for this type of procedure.   "
150523|NCT01313741|"     Two hundred patients will be analyzed both clinically (via validated outcomes measures) and     radiographically (via 2 sets of standard radiographs) to determine the survival and degree of     bone in growth of a novel all polyethelene glenoid component used in a standard FDA approved     shoulder arthroplasty system.   "
150524|NCT01313728|"     This study is to see if there's any difference in the amount of facial irritation when two     acne products are used together on one side of the face, compared to one acne treatment     product used alone on the other side of the face. All people participating in this trial will     be required to return to the same study center every weekday for two weeks for the     investigator to check for irritation on the face and to have the products applied - on     weekends they will have to put them on at home. If one side of the face is more irritated     than the other side, a picture will be taken as well.   "
150525|NCT01313715|"     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused     by viruses that belong to the enterovirus genus of the picornavirus family. Although most     HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71     (EV71) can present with a high rate of neurological complications, including     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by     EV71 has become a major emerging infectious disease in Asia and the highly pathogenic     potential of EV71 clearly requires the attention of world medical community.      Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China,     this clinical trial phase Ib is armed to evaluate safety in Chinese healthy children (from 13     to 60 months old) and infants (from 6 to 12 months old) and also provide the evidences for     the EV71 vaccine immunogenicity and the probable immunizing dose.   "
150526|NCT01313702|"     The purpose of this study is to determine whether a polipill improved the compliance with     treatment compared to usual care that use two or more drugs,in patients at high     cardiovascular risk or previous cardiovascular disease.   "
150527|NCT01313689|"     The purpose of this study is to confirm the clinical benefit observed in the pivotal     registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP)     required that a randomized study be conducted in CLL patients with bulky     fludarabine-refractory disease as a specific obligation for grant of conditional approval for     ARZERRA™ in the European Union (EU). This study will compare ofatumumab with the physicians'     choice of therapy.   "
150528|NCT01313676|"     The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival     in patients with chronic obstructive pulmonary disease with a history of or increased risk of     heart disease.   "
151196|NCT01304784|"     This study is an open-label, dose-escalation study of MM-111 with five different combination     treatments with the main goal of determining the safety of MM-111 with each combination.   "
150529|NCT01313663|"     This is a Phase II, randomized, open-label, multi-center study in advanced (Stage IVA and IVB     subjects per the International Association for the Study of Lung Cancer (IASLC) 2009 Lung     cancer staging schema) non-squamous NSCLC subjects comparing pazopanib relative to pemetrexed     in the maintenance setting. Subjects should have completed 4-6 cycles of induction therapy     with carboplatin + pemetrexed or cisplatin + pemetrexed and have had Stable Disease (SD),     Partial Response (PR) or Complete Response (CR) as the best response to be enrolled into the     study. The primary objective is to estimate the hazard ratio of progression free survival     (PFS) in advanced NSCLC subjects given maintenance therapy of pazopanib (Arm A) relative to     pemetrexed (Arm B). The secondary objectives are: overall survival, response rates, safety     and tolerability. A total of approximately 200 subjects will be enrolled and randomized in a     1:1 ratio. Safety and efficacy assessments will be regularly performed on all subjects.   "
150530|NCT01313650|"     This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group     study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719     Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a     Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who     meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period     followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a     total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will     be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal).     The total duration of subject participation in the study will be approximately 27 weeks. A     subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter     monitoring during the study and provide serial blood samples for pharmacokinetic analysis.     Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from     non-subset subjects. The primary measure of efficacy is clinic visit trough     (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by     adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter     monitoring (subset only).   "
150531|NCT01313637|"     This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group     study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719     Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a     Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who     meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period     followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a     total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will     be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal).     The total duration of subject participation in the study will be approximately 27 weeks. A     subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter     monitoring during the study and provide serial blood samples for pharmacokinetic analysis.     Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from     non-subset subjects. The primary measure of efficacy is clinic visit trough     (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by     adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter     monitoring (subset only).   "
150532|NCT01313624|"     The AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and     gram-negative airway infection. Participants received two 28-day courses of either Aztreonam     for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a     28-day off-drug period. Following the two blinded courses, all participants received a 28-day     course of open-label AZLI then were followed for an additional 56 days.   "
150533|NCT01313611|"     The objective of this study is to evaluate the complete response rate after a short induction     treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60 years old)     patients with untreated Follicular lymphoma, with an intermediate or high FLIPI score and     without high tumor burden.      This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction     schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8,     Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30     Maintenance schedule: 12 infusions of rituximab, each 8 weeks   "
150534|NCT01313598|"     The purpose of the study is to determine the safety and tolerability of GLPG0187 administered     through continuous intravenous infusion and to explore its preliminary clinical efficacy in     patients with solid tumors.   "
150535|NCT01313585|"     This study will compare the absolute and relative effectiveness of asthma management in     patients on inhaled corticosteroid (ICS) maintenance therapy as Easi-breathe® (EB) -     beclometasone dipropionate (BDP) breath-actuated inhaler (BAI) - and as-needed (prn) reliever     medication (short-acting beta2-agonist [SABA] therapy) via either a BAI (i.e. Easi-breathe®     [EB] salbutamol) or via a pressurised metered dose inhaler (MDI) (e.g. MDI salbutamol).   "
150536|NCT01313572|"     The purpose of this study is to see whether apadenoson is as effective as adenosine when used     as a pharmacological stress agent in myocardial SPECT-imaging (SPECT-MPI)to detect defects in     the supply of blood to the heart muscle (myocardial perfusion defects). The study will also     look at whether apadenoson is better tolerated than adenosine when used in SPECT-MPI.   "
150537|NCT01313559|"     This is an open label randomized phase II study for prostate cancer patients who have disease     progression after hormonal therapy. SOM230 LAR (Pasireotide) binds to its receptor of     prostate cancer cells and can prevent them from growing. Everolimus works by targeting a cell     survival factor in prostate cancer. The combination of these drugs may work better for the     treatment of prostate cancer without toxic chemotherapy. Patients will receive either SOM230     LAR (group A) or SOM230 LAR in combination with Everolimus (group B).   "
150589|NCT01312818|"     Both of bortezomib and vorinostat have identified Phase II doses for pediatric and adult     patients of which no grade 4 dose limiting toxicities have been observed in prior studies.     The pre-clinical synergy of these 2 agents when used in combination along with the lack of     over-riding toxicities and different mechanisms of action provide strong rationale for a     clinical trial investigating bortezomib and vorinostat in combination. This trial will use     the identified Phase II dose which is at or below the maximum tolerated dose for both agents     which have very acceptable toxicity profiles and such should prove feasible and tolerable in     this relapsed/refractory ALL population.   "
150538|NCT01313546|"     Objective: Continuous nerve block (freezing the nerve) is needed for knee replacement surgery     to reduce pain, increase rehabilitation and discharge patients home fast. A lot of time,     money and hospital resources are invested in inserting these catheters. The aim of this study     is to compare two end points used for insertion of continuous femoral nerve block and to see     which one results in fewer failures on the surgical ward.      Methodology: Patients having total knee replacement surgery will be recruited in this study.     Patients will be randomized into two groups. The continuous femoral nerve block catheter will     be inserted using ultrasound and nerve stimulation with two different end points (certain     muscle contraction).      Patients will be followed on day 1 and 2 after surgery to observe which catheter fails, how     much pain the patient suffers and how much painkiller the patients used.   "
150539|NCT01313533|"     The purpose of this study is to study the effects of polyarginine treated vein grafts on     graft patency for patients undergoing coronary artery bypass surgery.   "
150540|NCT01313520|"     This is a study to compare the effect of infliximab versus placebo on synovial inflammation     as measured by dynamic contrast enhanced (DCE)-MRI of one wrist. The primary hypothesis is     that over 14 weeks of therapy, the change from baseline in the volume transfer rate in     enhancing synovium is larger due to treatment with infliximab than with placebo.   "
150541|NCT01313507|"     This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III     study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks,     continuing the patient's infusion interval in the main study NCT01012323 [NGAM-01]) for 3     months. The primary objective of the study was to assess the safety and tolerability of high     infusion rates of NewGam.   "
150542|NCT01313494|"     The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg     Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.   "
150543|NCT01313481|"     The study aims to assess the effect on functional balance of Otago exercise performed as home     exercise versus group exercise. The investigators hypothesize that Otago exercise is more     effective performed as group exercise than home exercise.   "
150544|NCT01313468|"     It has been reported that obese individuals are seated 2 ½ hour more than lean individuals     and that non exercise thermo genesis (NEAT) may vary with as much as 2000 Kcal/day between     equal size people due to different occupational and leisure time activities. The primary aim     of the study is to investigate if 10 weeks of exercise training increase NEAT in sedentary     men.      Subject will be randomized to three different training intervention, with 3 exercise session     each week for 10 weeks. NEAT will be measured using an activity sensor and recorded over a 7     day period both before and after training.   "
150545|NCT01313455|"     Background:      - Polycystic ovarian syndrome (PCOS) is a group of disorders related to problems with the     secretion of certain hormones, which can lead to reproductive and other issues in women.     Frequent complications of PCOS include irregular menstruation, development of ovarian cysts,     and insulin resistance. The adrenal glands, which sit on top of the kidney, are involved in     the production of certain hormones and the regulation of steroid levels in the blood, and may     be affected in women with PCOS. Researchers are interested in studying possible connections     between the adrenal glands and PCOS in young women who have been diagnosed with PCOS and     healthy volunteers with normal menstrual function.      Objectives:      - To investigate possible connections between adrenal gland steroid hormone secretion and     polycystic ovarian syndrome.      Eligibility:        -  Women between 16 and 29 years of age who have been diagnosed with PCOS, or who are          healthy volunteers with normal menstrual function.        -  Participants must be willing to discontinue the use of oral contraceptives or any other          medications that alter steroid hormone production for at least 1 month before the start          of the study.      Design:        -  Participants will be screened with a physical examination, medical history, and blood          and urine tests. All participants will also have a pelvic (ovarian) ultrasound.        -  All participants will be admitted to the hospital for a 1-week testing period, which          will involve the following tests:        -  Regular blood draws for two 2-hour periods (late evening and early morning) to measure          hormone levels        -  Fasting blood draws with a dose of corticotropin to test the body's adrenal function        -  Hormone level measurement following regular doses of dexamethasone (a drug that controls          the function of the adrenal gland)        -  Daily urine collection for 6 days.        -  Other studies, such as imaging studies of the adrenal glands, may be conducted as          required by the study researchers.   "
150546|NCT01313442|"     Background:      - Gastrointestinal cancers can occur in the throat, stomach, gallbladder, liver, pancreas,     and colon. Researchers are interested in evaluating how active the immune system is in trying     to fight the cancer by studying blood and tumor tissue donated from individuals who have been     diagnosed with gastrointestinal cancers.      Objectives:      - To collect blood and tumor samples from individuals who have been diagnosed with     gastrointestinal cancers in order to study the immune system s response to the cancer.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with throat, stomach,     gallbladder, liver, pancreatic, or colon cancer, and are scheduled to be treated at the     National Institutes of Health.      Design:        -  The study will require at least one but no more than four visits to the National          Institutes of Health Clinical Center.        -  Participants will be screened with a physical examination and medical history, and will          provide a baseline blood sample for study.        -  Participants will provide additional blood samples 2 and 4 months after the baseline          sample, as well as a final sample at the completion of the treatment protocol.        -  Participants will provide tumor tissue samples only if they undergo a surgical procedure          related to the treatment for their gastrointestinal cancer.        -  No treatment will be provided as part of this protocol.   "
150547|NCT01313429|"     Background:      - Certain types of cancers, including sarcoma and melanoma, have specific antigens (protein     molecules) on their surfaces. Research has shown that producing an immune reaction to these     antigens may be able to keep tumors from growing by encouraging the immune system to destroy     the tumor cells. By creating a vaccine that contains antigens similar to those found on the     cancer cells, researchers hope to cause an immune reaction that targets the cancer cells.     However, more research is needed to determine the safety and effectiveness of this type of     vaccine treatment.      Objectives:      - To determine whether a tumor cell vaccine, given to individuals who have had surgery to     remove malignant tumors from the chest, can cause an immune reaction that will prevent the     tumors from coming back.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with cancer that has spread to     the lungs, pleura, or mediastinum, and have recently had surgery to remove tumors in the     chest.      Design:        -  Participants will be screened with a physical examination and medical history, as well          as blood tests and imaging studies.        -  Participants will have the option to have leukapheresis to collect white blood cells for          studies on how the body is responding to the vaccine. Participants who agree to have          this procedure will have it before the start of treatment and after the sixth and eighth          vaccines.        -  Seven days before the first vaccine, participants will receive the chemotherapy drugs          celecoxib and cyclophosphamide to take twice a day at home.        -  Participants will receive the experimental vaccine as an injection in the thigh or arm,          and may receive it in two shots depending on how many cells are in each vaccine.          Participants will receive a diary to monitor medication doses and side effects, as well          as additional cyclophosphamide and celecoxib to take at home as directed by the study.        -  Participants will have one vaccine every month for 6 months, and will have regular blood          tests and imaging studies. After the sixth vaccine, participants who have successfully          responded to the treatment will have two additional vaccines given 3 months apart.        -  After the eighth vaccine, participants will have followup visits every 3 months for 1          year and then every 6 months for up to 4 years....   "
151754|NCT01297413|"     The purpose of this study is to assess the safety and tolerability of allogeneic adult     mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.   "
150548|NCT01313416|"     Background:        -  In 2009, 49,096 patients were diagnosed with pancreatic cancer. Pancreatic cancer          carries a poor prognosis with an overall 5-year relative survival rate of 5.6%.        -  Many doctors believe that individuals who have had surgery to remove pancreatic cancer          should receive additional treatment, known as adjuvant therapy or adjuvant treatment, to          prevent the cancer from returning. One chemotherapy drug that has been found to be          effective in some patients with pancreatic cancer is called gemcitabine; it has been          shown to improve patient survival by 6 months. Researchers are searching for new drugs          or drug combinations to improve on these results.        -  One of the leading causes for immune suppression in cancer patients was suggested to be          associated with the elevated expression of programmed cell death ligand 1 (PD-L1) human          B7 homolog 1 (B7-H1) at tumor-involved sites, either by the tumor itself or by          surrounding cells like regulatory immune cells, resulting in the local suppression and          apoptosis of tumor infiltrating effector lymphocytes.        -  Some chemotherapy drugs kill cancer cells directly, but appear to prevent the immune          system from helping in that fight. The experimental drug CT-011 is designed to help the          immune system remain active to fight cancer cells. CT-011 has been tested in          laboratories and studied for use with a number of other cancers, but it has not been          given in combination with gemcitabine as a treatment for pancreatic cancer.      Objective:      - To test the safety and effectiveness of chemotherapy drugs gemcitabine and CT-011 as a     follow-up treatment for pancreatic cancer that has been surgically removed.      Eligibility:      - Individuals at least 18 years of age who have had surgery to remove pancreatic cancer and     have not had other types of follow-up treatments.      Design:        -  Participants will receive gemcitabine and CT-011 in 28-day cycles of treatment, and will          be monitored throughout their treatment.        -  Participants who do not have serious side effects and remain cancer-free may receive          this drug combination every 28 days for a total of 6 cycles.        -  Participants will have follow-up visits with additional blood tests every 2 months after          stopping treatment for up to 2 years.   "
150549|NCT01313403|"     Background:      - Medications to treat major depression act on a brain chemical called serotonin, which binds     to receptors on brain cells. More research is needed on how serotonin receptors work in the     brain, and imaging studies such as magnetic resonance imaging (MRI) can provide information     on how these receptors function in the brains of individuals with depression and healthy     volunteers. The experimental radioactive chemical [11C]CUMI has been designed to react with     serotonin receptors, and researchers are interested in studying its effectiveness using     positron emission tomography (PET) scanning to see how well it gets into the brain.      Objectives:      - To evaluate the effectiveness of the radiotracer [11C]CUMI in brain imaging studies of     serotonin receptors.      Eligibility:      - Individuals between 18 and 55 years of age who either have been diagnosed with major     depressive disorder or are healthy volunteers.      Design:        -  Participants will be screened with a full medical history, physical and psychiatric          examination, blood and urine tests, and questionnaires about mood. Participants will          also have an electrocardiogram at this visit.        -  At the first study visit, participants will have a MRI scan of the brain to provide          baseline data on brain function.        -  At the second study visit, participants will have a PET scan with the [11C]CUMI contrast          agent.        -  No treatment will be provided as part of this protocol....   "
150550|NCT01313390|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as docetaxel, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. It is not yet known whether giving     everolimus together with docetaxel is more effective than giving docetaxel alone in treating     patients with head and neck cancer.      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus given     together with docetaxel in treating patients with recurrent, locally advanced, or metastatic     head and neck cancer.   "
150551|NCT01313377|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Observation is watching a patient's condition but not giving     treatment until symptoms appear. It is not yet known whether giving gemcitabine hydrochloride     together with oxaliplatin is more effective than observation in treating patients with     biliary tract cancer that has been removed by surgery.      PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride     together with oxaliplatin to see how well it works compared with observation in treating     patients with biliary tract cancer that has been removed by surgery.   "
150552|NCT01313364|"     This is a single-arm, single-center study in healthy volunteers. This study is designed to     evaluate the safety of IM injections using single-use autoinjectors with a 25G × 1 needle.     The purpose of this study is not to evaluate study treatment; therefore, all injections will     be performed with Avonex placebo only; no active IFNβ-1a will be administered.   "
150553|NCT01313338|"     The purpose of this study is to examine the predictability of cognitive representation,     emotional responses, and hospitalization experience toward the decision to receive treatment     of the acute coronary syndrome patients.   "
150554|NCT01313325|"     The purpose of this study is to determine if adding hippotherapy treatment will improve     balance for children ages 5-17 who have disabilities such as cerebral palsy and down     syndrome. We also want to find out if by improving their balance the children increase their     participation in age appropriate activities.   "
150555|NCT01313312|"     The purpose of this research study is to assess the long term safety of Dysport® in     hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over     repeated treatment cycles.   "
150556|NCT01313299|"     The purpose of this research study is to assess the efficacy of Dysport compared to placebo     in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or     traumatic brain injury.   "
150557|NCT01313286|"     The purpose of this study is to compare 2 formulations of the study drug (LY2608204) in terms     of how much gets into the blood stream and how long it takes the body to get rid of it.     Information about any side effects that may occur will also be collected.   "
150558|NCT01313273|"     The aim of the study is to compare in an exploratory fashion the efficacy on progression-free     survival of lanreotide in addition to non steroidal anti androgens and LHRH-a in non     metastatic castrate resistant prostate cancer patients.   "
150590|NCT01312805|"     This study seeks to improve physician adherence to four recommendations of the NHLBI asthma     treatment guidelines:        1. Improve case detection of asthma among patients with pulmonary symptoms,        2. Grade all asthma patients asthma, identifying those with persistent versus intermittent          asthma,        3. Improve rates of use of controller medications - particularly inhaled steroids - among          patients with persistent asthma,        4. Provide an asthma treatment plan for all asthma patients.   "
150859|NCT01309295|"     This prospective observational study will assess the efficacy and safety of Mircera (methoxy     polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney     disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each     patient will be collected over 12 months of treatment.   "
150559|NCT01313260|"     Surgery may be an effective therapy for refractory focal epilepsies with a clear delineated     focus but surgical benefits are less clear for patients with a poorly defined focus such as     non lesional refractory partial epilepsies.      SEEG is considered the criterion standard to localize the epileptogenic zone (EZ) but the     procedure is risky with a limited spatial sampling. The development of non-invasive     neuroimaging alternatives is thus an important goal to improve EZ delineation and optimize     SEEG procedures.      The main hypothesis of this research project is the existence of a network organization     specific for each patient which allows the generation and propagation of epileptic     activities. The investigators wish to explore this network using diffusion tensor MRI to     study structural connectivity and MEG/FMRI to study functional connectivity. The     investigators will apply tools from the theories of complex networks and dynamical systems to     characterize the network organization of epileptic process.      The investigators aimed to identify and localize differences in connectivity parameters     between individual patients and a control group of healthy volunteers.   "
150560|NCT01313247|"     Randomised, double-blind placebo controlled cross-over trial      Main goal:      Optimize the medical pain treatment for patients with advanced cancer disease      Study goal:      Measure paracetamol's additional analgesic effect in a situation where the patient is     concomitantly treated with oral opioids eqv. morphine > 100 mg/d.   "
150561|NCT01313234|"     The purpose of this study is to investigate whether an intervention consisting of the     implementation of guidelines about daily systematic pain assessment following a theory based     education, targeting cancer-related pain and pain treatment, lead to a significantly positive     improvement in RNs knowledge of, and attitudes towards their pain management. Furthermore     will the interventions targeting the RNs influence the admitted patient's perception of their     cancer-related pain?   "
150562|NCT01313221|"     To estimate the difference in effectiveness between treatment with etanercept 50 mg twice     weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN)     topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.   "
150563|NCT01313208|"     This study is designed to evaluate the effectiveness of adding etanercept to disease     modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid     Arthritis (RA).   "
150564|NCT01313182|"     We hypothesize the application of mupirocin or povidone-iodine to the nares is equally     effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is     to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary     hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery     requiring implantation of prosthetic material, when the patient receives either nasal     mupirocin or nasal povidone-iodine prior to surgery.      Secondary study objectives include:        1. Measure hospital length of stay and re-admission rates in the mupirocin and          povidone-iodine groups.        2. Measure adverse events related to mupirocin and povidone-iodine.        3. Measure rate of SA resistance to mupirocin.   "
150565|NCT01313169|"     The investigators conducted a controlled trial to assess the effectiveness of electronic     medical record (EMR) reminders, with or without a panel manager, on completion of health care     proxy, osteoporosis screening, and influenza and pneumococcal vaccinations for patients age     65 or older. The investigators hypothesized that EMR reminders would improve adherence to     practice guidelines and that benefits would be enhanced with the support of a panel manager.   "
150566|NCT01313156|"     Prospective, non-randomized cohort study to analyse genetic variations, dietary patterns,     perceived stress and anxiety and early changes in lipid metabolism leading to the metabolic     syndrome and type 2 diabetes   "
150567|NCT01313143|"     Pharmacokinetics, pharmacodynamics and tolerability of AOP200704 infusion is compared to that     of Esmolol by measurement of plasma concentrations of AOP200704, esmolol and their     metabolites, by assessing the effect of both drugs on dobutamine-induced tachycardia, and by     monitoring vital signs, ECG and adverse events.   "
150568|NCT01313130|"     Traumatic brain injury can cause permanent problems with thinking, memory, control of     emotions, organization and planning. Thousands of soldiers, marines, and other military     personnel have had injuries to the brain due the wars in Iraq and Afghanistan. Very large     numbers of civilians, up to perhaps 1.5 million people per year, in the United States also     have traumatic brain injuries caused by car accidents, falls, sports-related injuries or     assault.      We don't know very much about traumatic brain injuries right now, but there are some     important new advances in technology that may help us learn a lot more about these injuries.     One such advance involves new types of MRI scans that we think will be able to show what has     happened to the brain after trauma more clearly that regular scans can. The first new scan is     called diffusion tensor imaging, which shows injury to the axons (the wiring of the brain).     The second new scan is called resting-state functional MRI correlation analysis, which shows     how well various parts of the brain are connected to each other. Importantly, the new types     of scans can be done using regular scanners that we already have in every major hospital. The     innovation is entirely in how the scanners are used and how the resulting pictures are     analyzed on a computer after they have been taken. We have already tested these scans on some     military and civilian patients with brain injury and found them to be very helpful so far.     Our overall goal is to see whether these new MRI scans will be useful for active duty     military personnel who have had recent traumatic brain injuries. The most important goal will     be to see if the amount of injury shown on the scans be used to predict how well the patients     will do overall over the next 6-12 months. A related goal will be to see whether injuries to     specific parts of the brain seen by these new scans can be used to predict whether patients     will be likely to have specific problems like memory loss, attention deficit, depression, or     post-traumatic stress disorder. We would also like to see whether the scans could be even     more useful when combined with information about genetic factors (inherited from the parents)     that can be tested in the blood. Another important goal is to compare the effects of     traumatic brain injuries caused by blasts or explosions with injuries from other causes, to     find out what is unique about blast injury. A final goal will be to repeat the scans 6-12     months later to see whether the new MRI scans can show whether the injuries to the brain have     healed, gotten worse, or stayed the same. These new scans could help with decisions about     whether military personnel can return to duty, what sort of rehabilitation and treatment     would benefit them most, and what family members should watch for and expect.   "
150569|NCT01313117|"     This study is being done because peripheral neuropathy, a condition that interrupts sensation     in your limbs, is a common side effect of paclitaxel. There is some evidence that alpha     lipoic acid (ALA), an antioxidant compound, protects neurons after exposure to paclitaxel.     The purpose of this study is to assess the safety and tolerability of ALA and to find the     best dose of ALA in patients that receive chemotherapy.   "
150570|NCT01313104|"     This clinical trial studies colposcopy and high resolution anoscopy in screening for anal     dysplasia in patients with cervical, vaginal, or vulvar dysplasia or cancer. Screening may     help doctors find cancer cells early and plan better treatment for cancer   "
150618|NCT01312428|"     The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL)     instrument in achieving desired acetabular position, desired leg length and offset after     Total Hip Replacement (THR) reconstruction.   "
150571|NCT01313078|"     Background:      - The best treatment for ovarian and related female reproductive tract cancers is not yet     known for patients whose disease has not responded to or has recurred after standard     treatment. The cancer treatment drug pegaspargase (ONCASPAR (Trademark)), which works     differently from standard chemotherapy, has been approved to treat leukemia and has been     given to a small number of patient with ovarian and other types of cancer. Because     pegaspargase may reduce the development of cancer cells and blood vessel cells that     contribute to cancer growth and ability to spread, treatment with pegaspargase could shrink     ovarian cancer tumors and help ovarian cancer patients live longer and with fewer symptoms     from their disease.      Objectives:      - To evaluate the safety and effectiveness of pegaspargase in patients with recurrent or     refractory ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer.      Eligibility:      - Women at least 18 years of age who have been diagnosed with epithelial ovarian cancer,     fallopian tube cancer, or primary peritoneal cancer that has not responded to at least one     operation, chemotherapy, and/or radiotherapy.      Design:        -  Before the start of the study, participants will be screened with a medical history,          blood tests, imaging scans of the affected areas, tumor biopsies, and other tests as          directed by the study doctors.        -  Participants will receive an infusion of pegaspargase on Day 1 and Day 15 of each 28-day          cycle.        -  Participants will have dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at          the start of the study, before beginning pegaspargase, and again 6 weeks into the          treatment. This test will determine if pegaspargase is affecting blood flow to the          cancer site.        -  Participants will have a computed tomography scan or other imaging every other cycle          (approximately every 8 weeks) to determine whether the therapy is affecting the cancer          site.        -  The treatment will be repeated as long as the participant tolerates the medication and          his or her cancer is either steady or improving.   "
150572|NCT01313065|"     The purpose of this study is to evaluate the safety and tolerability of IV administration of     VX15/2503 in patients with advanced solid tumors. The escalation part of the study will     determine the maximum tolerated dose (MTD).   "
150573|NCT01313052|"     The FACT model (ACT + legal leverage in the form of judicial monitoring) will be compared to     enhanced outpatient treatment (close outpatient follow-up without judicial monitoring).     Seventy adults with psychotic disorders in Monroe County who are convicted of a misdemeanor     will be randomly assigned to each treatment group and followed for 12 months. Primary     outcomes will include criminal justice and mental health service utilization rates, treatment     adherence, psychiatric symptoms, substance abuse, homelessness, perceived coercion, and     consumer satisfaction. Service utilization outcomes will be tracked using established mental     health and criminal justice databases.      Hypotheses are:        1. FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in          promoting treatment adherence among high-risk adults with psychotic disorders.        2. FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in          preventing arrest, incarceration, emergency department and inpatient hospital use among          high-risk adults with psychotic disorders.   "
150574|NCT01313039|"     If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be     possible to effectively use hormonal therapy in these patients resulting in improved     outcomes. The investigators propose a single-arm Simon two-step study to examine whether     treatment with AZD6244 will result in increased ER expression in ER-negative/low primary     breast tumors.   "
150575|NCT01313026|"     A randomised trial testing the effect of percutaneous nerve evaluation and transanal     irrigation on bowel function in patients after low anterior resection for rectal cancer.   "
150576|NCT01313013|"     question prompt sheet for outpatients suffering from depression. effects on     patient-doctor-communication during the consultation.   "
150577|NCT01313000|"     The objective of this pilot study is to observe the utility of autologous transfer of fat     collected using ultrasonic assisted liposuction into the upper arms with ultrasonic     visualization.   "
150578|NCT01312987|"     The purpose of this research study is to assess what impact an integrated educational and     feeding intervention delivered to infants and children has on growth (weight and height),     development (cognitive and gross motor), nutrition (dietary behaviors, food insecurity, and     micronutrient status - folate, iron, zinc, vitamin A, vitamin D), and morbidity (respiratory     and diarrheal) outcomes. A randomized community trial was used to implement a nutrition     intervention program consisting of monthly education sessions, a lipid-based nutrition     supplement, and food vouchers for local staples.   "
150579|NCT01312961|"     Primary Objective:      To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC)     once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma     exacerbation in participants with persistent moderate to severe eosinophilic asthma.      Secondary Objectives:        -  To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in          participants with persistent moderate to severe eosinophilic asthma.        -  To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in          participants with persistent moderate to severe eosinophilic asthma.   "
150580|NCT01312948|"     This study will evaluate a newly developed pediatric mask (known as Pixi) on children aged     2-7 using continuous positive airway pressure (CPAP), or Non-invasive ventilation (NIV)     treatment. The participants will undergo a monitored sleep study, followed by a 7 night trial     of the Pixi mask in the home environment. During the study usability will be measured through     questionnaires filled in by the parent and clinician.      The study hypothesis is that the usability of the mask will be superior to the patient's     usual mask.   "
150581|NCT01312935|"     The study investigates the safety and efficacy of PMX-60056 for the Reversal of Heparin in     Patients Undergoing Percutaneous Coronary Intervention (PCI)   "
150582|NCT01312922|"     The overall objective of this trial is to demonstrate clinically relevant superior     antidepressant efficacy of the fixed dose combination PNB01 (low dose pipamperone and     citalopram) over reference antidepressant treatment with citalopram alone, and a low dose of     psychoactive pipamperone alone in patients with moderate to severe Major Depressive Disorder.      This study was specifically designed to assess patient related outcome (PRO) parameters using     an Interactive Voice Response System (IVRS) via telephone.   "
150583|NCT01312909|"     The study is designed to see if varenicline combined with age appropriate (adolescent)     smoking cessation counseling will help teens quit smoking.   "
150584|NCT01312883|"     Postpartum depressive symptoms are a major health problem that affects hundreds of women     annually. The investgators propose to test an intervention to reduce postpartum depressive     symptoms and prevent elevated levels of depressive symptoms in postpartum mothers by     preparing and educating women about specific situational triggers of depressive symptoms, by     bolstering personal and social resources, by enhancing self-management skills to buffer     postpartum demands, and by increasing access to existing healthcare and community resources     available to postpartum mothers.   "
150585|NCT01312870|"     The purpose of this study is to determine whether postoperative nutritional support improves     postoperative outcomes in cardiac patients with malnutrition .   "
150594|NCT01312740|"     The investigators evaluated whether an energy-restricted protein diet with low glycaemic     index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional     diet (LC-CONV) on weight-loss and related metabolic variables.   "
150595|NCT01312727|"     The aim of this study is to identify families with hereditary chronic tubulointerstitial     renal diseases , characterize the phenotype and screen for mutations in known genesis (UMOD,     REN, TCF2, NPHP1). Genome wide analysis will be performed in families without mutations     identified.   "
150596|NCT01312714|"     Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated     with cardiovascular risk factors such as increased aortic pulse wave velocity, blood     pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect of     26 weeks of vitamin D3 supplementation in patients with end stage renal disease.   "
150597|NCT01312701|"     Tumors have a systemic immune modifying effect. They affect the immune system similarly to     states of chronic inflammation and these effects can:        -  be monitored through analysis of nk t and myeloid cells mainly through studies of the          zeta chain but also through other means        -  may be decreased following effective anticancer therapy - may even be used to study the          effectiveness of anticancer therapy        -  are important to monitor if the investigators plan on formulation of systemic immune          therapy Thus immumonitoring of systemic blood cells may turn out to be an important          prognostic and predictive factor in many cancer types   "
150598|NCT01312688|"     The cardiovascular system plays a central role in the pathophysiology and prognosis of     sepsis, yet the correct hemodynamic management of septic patients is still vigorously     debated. Despite guidelines, the use of CVP and PAOP is seriously criticized for inaccurate     prediction of fluid requirement. Recently studies showed that early goal-directed therapy     (EGDT) aimed at achieving a ScvO2 of ≥70% significantly improved survival of septic shock     patients, yet EGDT has not been adopted by all intensivists. The investigators have recently     found using 2D echocardiography in 262 patients with severe sepsis or septic shock and     treated by the conventional guidelines (without ScvO2) that diastolic dysfunction and reduced     stroke volume index are strong independent predictors of mortality. In the present study the     investigators intend to test the effect of EGDT on resuscitation, on long term myocardial     function and left ventricular volumes and on survival in ICU patients with severe sepsis and     septic shock. Patients will be randomized to EGDT (resuscitation directed by ScvO2) or     standard of therapy for the first six hours after diagnosis of severe sepsis or septic shock     and admission to the ICU. After six hours patients in septic shock will be further monitored     with non invasive cardiac output (PiCCO, Pulsion Technologies). All patients will be followed     daily by 2D & 3D transthoracic echocardiography with detailed measurements of systolic and     diastolic left and right ventricular volumes and functions. Patients in the EGDT group will     be compared to the control group for parameters of initial resuscitation (fluid volumes,     ScvO2 achieved, inotrope use), initial values from non invasive cardiac output at six hours,     interventions required from institution of non invasive cardiac output, early and long term     effects on cardiac function and volumes from echo measurements, and mortality. The     effectiveness of EGDT will thus be examined in the short and long terms.   "
150599|NCT01312675|"     The purpose of this study is to determine if Selective Adsorption System for Removal of     Bacterial Toxins (S.A.F.E.BT) therapy is effective in the treatment of severe sepsis.   "
150600|NCT01312662|"     Purpose of this study is to investigate the agreement, the test-retest reliability of three     established and widely used visual acuity tests, to develop a mathematical transformation     routine between the results from these three tests, to assess the examinees´ and examiners´     acceptance and to compare the test durations.   "
150601|NCT01312649|"     The investigators aim is to understand the cognitive mechanisms that contribute to the     emergence of delusions of control (the belief that one's own actions or thoughts are     controlled by an external force). These symptoms are mainly encountered in patients with     schizophrenia, and the investigators will distinguish patients with schizophrenia with or     without this symptom together with patients with bipolar disorder. Based on the investigators     previous studies, this project will help to determine the role of two elementary mechanisms     in the ability to feel in control of voluntary actions: (1) the processing of the sensory     consequences of action, and (2) the ability to build mental representations for sequenced     actions.   "
150602|NCT01312636|"     This study is conducted in Japan. The aim of this observational study is to evaluate the     long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in     subjects with congenital FVII deficiency.   "
150603|NCT01312623|"     Cardiac surgery is associated with risk of perioperative inflammation and ischemia leading to     cerebral and myocardial morbidity and mortality. Ischemic preconditioning by repetitive     ischemic episodes at an organ can reduce damage resulting from consecutive prolonged ischemia     in that organ. Remote ischemic preconditioning is defined as ischemic preconditioning by     repetitive ischemic episodes of an organ remote from the organ to be protected, e.g. ischemic     episodes of a limb can reduce ischemic damage of the heart. Animal studies as well as human     studies have shown that ischemic preconditioning can protect the heart from intraoperative     ischemia. Remote preconditioning by repetitive limb ischemia has been applied in humans in     some studies.12-14 However, the published data is not yet sufficient to support evidence     based recommendations for clinical practice. In particular, available data regarding the     influence of remote preconditioning on inflammatory and ischemic damage of brain and heart in     children following surgery of congenital heart disease are limited. Hence, this prospective,     controlled and randomized study was designed to perform remote ischemic preconditioning in     children after induction of anesthesia for pediatric heart surgery and to investigate the     effect on postoperative organ function in comparison to a control group.   "
150724|NCT01310036|"     This open-label, single arm study will evaluate the safety and efficacy of Tarceva     (erlotinib) as first-line therapy in patients with stage IV or recurrent non-small cell lung     cancer who harbour epidermal growth factor receptor (EGFR) mutations. All patients will     receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity     occurs. At the investigator's discretion, patients may receive Tarceva beyond disease     progression.   "
150604|NCT01312610|"     This study is investigating the effect of 8 weeks of orange juice supplementation on     executive function in healthy older adults. The study is a controled, double-blind, crossover     trial and involves a 8 week supplementation with a high flavonone orange juice and a     carbohydrate-matched control. Volunteers consume 500ml of either the test juice or the     control juice per day for an 8 week period. There is then an 8 week washout period before     subjects proceed to the other arm of the study. Subjects are randomly assigned to either arm     at the beginning of the study. Measures of cognitive function will be administered pre and     post both test and control interventions. Blood pressure will also be measured and blood and     urine samples will be collected to assess absorption of from the juice. A sub-sample of     volunteers will undergo MRI imaging pre- and post intervention to acquire cerebral blow flow     information.   "
150605|NCT01312597|"     The purpose of this study is to investigate changes in cerebral blood flow, blood flavonoid     levels, brain-derived neurotrophic factor, vascular reactivity and cognitive performance in     young adults as a result of acute administration of a fruit-derived flavonoid-rich or     flavonoid-poor drink.   "
150606|NCT01312584|"     The primary propose of this study is to determine how processing, in particular alkalisation,     alters the vascular effects of high-flavanols foods such as cocoa   "
150607|NCT01312571|"     Forty-eight people diagnosed with social phobia in an experimental study that randomized into     two treatment groups: 1) Internet-based Cognitive Behavioural Therapy (iCBT) (n = 24) or 2)     computerized attention training (n = 24). After nine weeks we change the condition of the two     groups of research participants, which should therefore be given both treatments. Pre-and     post measurement of functional magnetic resonance imaging (fMRI) will take place in the first     round of treatment. Genotyping based on saliva samples takes place before the start of     treatment, at the first fMRI measurement, for those who voluntarily leave the sample.      Study hypothesis      How is the brain activity of emotional processing and anxiety affected after completing an     Internet-based CBT compared with computerized attention training? Does the treatment response     of an Internet based treatment affects by variations in serotonin-transporter-linked promoter     region (5-HTTLPR) and tryptophan hydroxylase-3 (TPH3) genes?      How is the genetic variations related to symptoms in social phobia (pre treatment)?   "
150608|NCT01312558|"     This study aims to investigate the role of the Mediterranean diet in obese patients with     Obstructive sleep apnoea-hypopnoea syndrome.   "
150609|NCT01312545|"     This study wants to compare between two types of implants in enucleation. Both of them are     made from porous polyethylene but have different fabricating techniques. The investigators     chose an exposure rate as a main outcome because the investigators think it is the most     important outcome for the surgeons. The study hypothesis is: Is the exposure rate of a     local-made polyethylene orbital implant the same as an imported one?   "
150610|NCT01312532|"     The purpose of this study is to determine which prosthesis is better in total knee     arthroplasty   "
150611|NCT01312519|"     This is a randomized study evaluating use of a powered bone marrow biopsy and aspiration     system (OnControl by Vidacare) compared to traditional manual devices. The hypothesis is that     the powered system will reduce the level of patient pain during the aspiration and core     biopsy procedures and the amount of time needed to perform the procedures.   "
150612|NCT01312506|"     This study has two ultimate goals:        1. Understand how the original melanoma from the skin spreads to the CNS. In order to study          this we need to collect (and compare) the original skin melanoma, the CNS melanoma, as          well as any other melanoma that has not metastasized to the CNS.        2. Develop a diagnostic blood test that will early identify subjects at high risk for          developing CNS metastasis or patients who may already have CNS metastasis but the MRI or          the CAT scan cannot yet detect it. Thus, the investigators plan to collect CSF from          subjects like you who have melanoma CNS metastases in order to confirm the presence of          this biomarker.   "
150613|NCT01312493|"     This is a non-randomized phase II study of targeted radiotherapy (RT) administered     concurrently with panitumumab in patients with locally advanced squamous carcinoma of the     head and neck.   "
150614|NCT01312480|"     This is a study of the effectiveness of adolescent smoking cessation interventions in     pediatric primary care settings. Our specific aims are to:        1. Demonstrate providers' fidelity to guidelines for tobacco counseling and delivery of          cessation interventions using practice system changes over time, (including systematic          screening using charting tools and linkages to adjunct materials, including self-help          handouts and Internet resources); and        2. Assess the impact of primary care provider counseling interventions on adolescent          smoking cessation.      We hypothesize that adolescents who receive guidelines-based clinician-delivered smoking     cessation counseling at primary care visits will be more likely to make quit attempts and     more likely to remain abstinent (with better long term cessation rates) at 6 and 12 months     after intervention, compared to those who do not receive interventions. In addition, we     hypothesize that successful referral to stage-based self-help adjuncts, and more adjunct use     will be associated with more quit attempts and better long-term cessation rates.      We will evaluate provider interventions in up to 120 pediatric practices, recruited from the     American Academy of Pediatric's Pediatric Research in Office Settings (PROS) practice-based     research network. Adolescents presenting for care will complete a short baseline survey prior     to their doctor-visit, and a percentage of participants will be surveyed by phone 4‐6 weeks     after their visits to assess quit attempts and short-term cessation, and again at 6 and 12     months to evaluate long-term cessation outcomes. We will describe the patterns of smoking     among youth, and explore how much receiving interventions affects motivation, quitting,     abstinence/relapse attitudes, attitudes and use of adjunct strategies, and other smoking     behaviors for adolescent smokers.   "
150615|NCT01312467|"     The purpose of this study is to find out whether METFORMIN decreases protein markers in     colorectal tissue. This is a phase IIA study of the pharmacodynamics, safety and tolerability     of Metformin in decreasing colorectal mucosa in patients with a history of colorectal     adenomas in the past 3 years and a BMI >= 30, with decimals rounded to the nearest whole     integer. Metformin as a potential chemopreventive agent for inhibition of the relevant     molecular pathways involved in human colorectal carcinogenesis.   "
150616|NCT01312454|"     The purpose of this study was to assess the safety and efficacy of AL-59412C injected     intravitreally relative to Vehicle.   "
150617|NCT01312441|"     The prevalence of vitamin D deficiency increases as kidney function declines. As a result,     many hemodialysis patients often have low levels of vitamin D. Recent evidence has shown that     vitamin D supplementation may improve many aspects of poor health such as heart disease and     inflammatory markers. The objectives of this study are to determine how supplementing     dialysis patients with ergocalciferol increases vitamin D levels, how long vitamin D levels     can be maintained after a 6 month treatment course, and to examine the effect of     ergocalciferol on biomarkers of inflammation and vascular health.   "
150619|NCT01312415|"     Total knee replacement (TKR) is associated postoperatively with considerable pain and     analgesic requirement. Total knee replacement is routinely performed under spinal anaesthesia     with intrathecal bupivacaine plus preservative free morphine. We hypothesize that     infiltration of the surgical site with peri- and intraarticular levobupivacaine local     anaesthetic would be an efficacious pain management technique and would not be inferior to     intrathecal morphine for postoperative pain management.      We further hypothesize that the use of this surgical site infiltration technique would     decrease post-operative systemic opioid requirements as well as the side effects associated     with intrathecal and systemic opioids.   "
150705|NCT01311258|"     This study is being performed to develop assays to determine the impact of the therapy     patients receive for treatment of AML or MDS and to determine if these tests can identify     those patients who are at a greater risk for having their disease relapse.   "
150620|NCT01312402|"     This study is a prospective, single crossover, double-masked, controlled clinical trial that     will use topical brinzolamide (Azopt)ophthalmic medication to try to improve the nystagmus     and visual consequences of nystagmus in patients with infantile nystagmus syndrome (INS).     Subjects will undergo a clinical exam, questionnaire and eye movement recordings on day 1 and     then receive either topical Azopt or placebo three times a day in both eyes for days 2,3 and     4 followed on the morning of day 5 by a repeat clinical exam, questionnaire and eye movement     recordings. After at least one week, this protocol is repeated with the crossover regimen     being taken by the subject. One week after all medications are discontinued, another clinical     exam is done before study discharge. The hypothesis is that nystagmus and associated visual     symptoms will be improved while on the Azopt compared to the placebo. There will be a total     of 5 visits over a 1-2 month period.   "
150621|NCT01312389|"     This is a Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or     primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity     of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L)     administered by intradermal/subcutaneous injection in combination with Ampligen     (poly-l:poly-C12U), a Toll-like receptor 3 agonist. Study duration is 24 months.   "
150622|NCT01312376|"     This is a phase-I clinical trial to determine the feasibility and safety of     Cyclophosphamide/Fludarabine Lymphodepletion and an immunomodulatory combination of     Interferon-alpha Bevacizumab and Aspirin followed by adoptive transfer of vaccine-primed ex     vivo CD3/CD28-costimulated peripheral blood autologous T cells and vaccination with whole     tumor vaccine administered intradermally in combination with Bevacizumab in patients with     recurrent ovarian cancer fallopian tube or primary peritoneal cancer. (Funding Source - FDA     OOPD)   "
150623|NCT01312363|"     The investigators plan to see what factors can influence the durability of Exelon patch     treatment in Korean patients with Alzheimer's disease.      Based on these results, the investigators will find the ways to maximize the effect and     durability of Exelon patch on Korean patients with Alzheimer's disease.      After finishing this study, the investigators are going to present the study results at the     international and national academic meetings or conferences.      Also the investigators expect that they can publish the result in a journal of in the field     of neurology or dementia till the winter of 2010.   "
150624|NCT01312350|"     The investigators will examine whether 2-cycles of DFP chemotherapy before definitive     concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally     advanced (Stage III & IVM0) hypopharyngeal and base of tongue carcinoma compared to     definitive CCRT alone.   "
150625|NCT01312337|"     The investigators will examine efficacy and toxicity of gefitinib in Korean patients with     EGFR wild tumors diagnosed with direct sequence test.   "
150626|NCT01312324|"     We try to evaluate whether neoadjuvant docetaxel plus cisplatin can increase the complete     resection rate in advanced thymic carcinoma.   "
150627|NCT01312311|"     The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the     first-line therapy for recurrent of metastatic nasophayngeal cancer   "
150628|NCT01312298|"     Hypothesis: General anesthesia as compared to intrathecal (i.e. spinal anesthesia) anesthesia     will result in shorter length of hospital stay for patients undergoing total knee     arthroplasty.      Primary endpoint: time from end of surgery until the patient is street ready      Secondary endpoints: will general anesthesia produce less postoperative pain as compared to     intrathecal anesthesia? Is there any difference in post operative dizziness between the     groups.   "
150629|NCT01312285|"     The purpose of this study is to see if using a device called the Resonator, that puts out     very low level electromagnetic fields will help symptoms of painful hip(s)   "
150630|NCT01312272|"     Individuals with schizophrenia have been found to have deficits in social cognition, which is     defined as the functions that are engaged during social interactions. Social cognition has     been found to be critical in predicting multiple aspects of community functioning. There are     no currently available medications that have been consistently found to improve social     cognition in individuals with schizophrenia. Oxytocin functions as a neurotransmitter that is     thought to be involved in multiple aspects of social behavior and related emotions. In this     study, we test the hypothesis that acute administration of intranasal oxytocin will improve     social cognition in individuals with schizophrenia.   "
150631|NCT01312259|"     Purpose:        1. To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral          neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome          (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a          frequency of 14 hertz (standard).        2. The evaluate the efficacy of the two frequency settings on the other associated          conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction          (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of          the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).   "
150670|NCT01311739|"     The purpose of this study is to assess and compare the pharmacokinetics (PK) of     cyanocobalamin after the oral administration of Eligen® B12 (cyanocobalamin/SNAC), oral     cyanocobalamin alone (commercially-available formulation) and cyanocobalamin administered     intravenously (IV) (also a commercially-available formulation) to healthy male subjects under     fasting conditions. The safety and tolerability of oral Eligen® B12 (cyanocobalamin/SNAC)     versus oral cyanocobalamin alone and versus IV cyanocobalamin are also assessed.   "
150725|NCT01310023|"     SMARTT will estimate the incidence of conditions and diagnoses potentially related to in     utero exposure to antiretroviral therapy and/or exposure in the first two months of life     among children born of HIV-infected mothers.   "
150692|NCT01311427|"     Data from two recent Tai chi studies have found that Tai Chi yields symptomatic benefit in     patients with fibromyalgia (FM). The purpose of this study is to confirm those findings in a     larger randomized, controlled clinical trial in a community-based setting. We also sought to     extend this line of inquiry by closely examining Tai chi's effect on physical function,     specifically postural stability. Towards these ends, we conducted a single-blind, randomized     controlled clinical trial of an FM modified 8-form Yang-style Tai chi program compared to     standard education. Subjects in both conditions meet in small groups two times weekly for 60     minutes over 12 weeks.   "
150632|NCT01312246|"     In this study the investigators will include adult patients who are not part of a vulnerable     patient population. Inclusion criteria include patients who will be undergoing resection of     part of their colon that will require dividing the IMA. The investigators will use the     resected surgical specimens for our project. The investigators will use the EnSeal on all     major vessels in our procedure. The investigators will use the EnSeal 5 mm round head model.     Due to the nature of the project, we will apply for IRB approval prior to beginning our     research. The investigators plan to include 60 total patients in the study, 30 at the     University of Illinois and 30 at Lutheran General Hospital.      Prior to resection, the investigators will use a sterile caliper to take an in-vivo     measurement of the IMA and IMV. Immediately after resection, the investigators will remove     the sealed proximal end of the IMA and the 3 cm distal to it from the surgical specimen. The     investigators will similarly prepare the IMV. The investigators will inspect our vessels for     any iatrogenic traumatic tears. If the vessels are suitable, the investigators will then     gentle apply manual traction to remove any blood or clots within the lumen. The investigators     will measure the outer diameter of the vessels using a digital caliper. If there are small     branches, the investigators will tie them off with suture. The unsealed end will then be     attached to the burst pressure tester with suture and it will be tested for the bursting     pressure. The device measures pressure continuously as it infuses the segment with normal     saline at a steady rate (50 ml/hr). A leak will be determined by a decrease in intra-luminal     pressure of 100 mm Hg or a visible leak. A failure to seal the vessels will be determined by     a bursting pressure of less than 100 mm Hg. It should be noted that each section would only     be pressure-tested once. All of our data will be collected on the enclosed data sheet we have     created for use in this protocol. The investigators will then place the vessels with the     original surgical specimen where it will be submitted for routine pathological examination of     surgical specimens. Twenty five specimens at each site will undergo the testing, whereas 5     specimens will be sent to pathology without testing.      Our pathologist will analyze the submitted specimen for extent of seal, disruption of vessel     smooth muscle, gas bubbles, and will stain for elastin to analyze the disruption in the     vessel wall. In addition, the seal will be measured and we will obtain digital images. The     specimens submitted for pathology will be 5 burst specimens as well as 5 un-burst specimens     taken from the pool of 25 patients at UIC.      For our human component, the investigators have estimated the standard deviation and width of     the confidence interval to be 100 mm Hg each. With a 95% confidence level, the investigators     expect to require 16 measurements for human specimens from 16 patients although the     investigators will use 50 patients to allow for errors in obtaining pressures.      Our timeline for the completion of the projects is 6 months. The investigators plan on being     able to complete the human burst pressure testing within 6 months.   "
150633|NCT01312233|"     The purpose of the Collaborative Care for Older Adults with Back Pain (COCOA) Clinical Trial     is to evaluate the clinical effectiveness and feasibility of a collaborative care model     (medical and chiropractic care) through a pragmatic, prospective pilot trial conducted with     120 older adults over the age of 65 with low back pain of at least 1 month duration.   "
150634|NCT01312220|"     To study the correlation of serological growth factors and the hepatic progenitor cells     involved in liver regeneration of liver failure.   "
150635|NCT01312207|"     Objective: To evaluate the clinical manifestations and surgical prognosis of macular     tractional retinoschisis in proliferative diabetic retinopathy.      Design: Retrospective case series. Participants: Cases with macular tractional retinoschisis     with or without combined traction detachment (TRD) in proliferative diabetic retinopathy     confirmed by optical coherence tomography (OCT) at a single institution between January 2007     and August 2010.      Methods: Cases were divided into two groups. Group A had tractional retinoschisis only while     Group B had TRD with retinoschisis of the elevated retina. Clinical data including OCT     findings were recorded and analyzed.      Main Outcome Measures: Demographic data, clinical pictures, surgical results, and OCT     findings will be compared between two the groups.   "
150636|NCT01312194|"     The main objective of this study is the prevention and repair of apical periodontitis in     lower molars with pulp necrosis after the execution of endodontic treatment in one or two     visits in adolescent patients. Moreover, it is also observed the frequency of postoperative     pain in endodontic treatment.   "
150637|NCT01312181|"     Among HIV-infected individuals, non-injection drug use (NIDU) is associated with poor HIV     medication adherence, greater HIV/AIDS risk behaviors, and increasing non-AIDS mortality.     Thus reducing NIDU among HIV infected individuals is critical to their survival and to     limiting the spread of HIV. We propose to study the efficacy of a technologically enhanced     brief intervention (HealthCall) to reduce NIDU in HIV primary care patients that demands     little from busy medical staff and is well accepted by patients. In a 3-arm randomized     clinical trial will test the efficacy of (a) Motivational Interviewing (MI)+HealthCall; (b)     MI-only; and (c) a control condition (advice + DVD HIV health education) in reducing NIDU.   "
150638|NCT01312168|"     This purpose of this study is to        1. Determine the change in endothelial dependent vascular reactivity and vascular          properties        2. Determine the changes in monocytes activation        3. Determine the change in pro-inflammatory status        4. Investigate the effect of six-month CPAP therapy on the above changes in patients with          OSA   "
150639|NCT01312155|"     The study investigates assisted intubation using a videolaryngoscope in anesthesia.   "
150640|NCT01312142|"     Weaning from mechanical ventilator is an essential element in the care of critically ill     intubated patients receiving mechanical ventilation. It covers the entire process of     liberating the patient from mechanical support and from endotracheal tube.      The process of weaning involves two-step strategies: 1. Assessment of readiness for weaning,     including physiological measurement, such as maximum inspiratory pressure, tidal volume,     respiratory rate and etc. 2. Spontaneous breathing trial.      Tracheostomy has become an increasingly common intervention in ICUs, especially for patients     with prolonged mechanical ventilator support.      Tracheostomy may reduce work of breathing by improving some aspects of pulmonary mechanics,     such as reducing dead space and decreasing airway resistance, but to date, there is no     evidence that this is linked to reduction in weaning time or length of stay.      The investigators believe such improvement in pulmonary mechanic, which may reflect in the     weaning parameter that respiratory therapist measured before weaning program, may be     different from that measured before tracheostomy creation.      The investigators therefore hypothesized that the improvement in pulmonary mechanic for     patients with weaning failure after tracheostomy may reflect on weaning parameters, and that     this improvement may be able to predict the subsequent successful weaning from mechanical     ventilator support.      Hereby the investigators perform a prospective single-center study to investigate the changes     of weaning parameters in difficult weaning patients after tracheostomy as a predictor of     subsequent successful weaning.   "
150671|NCT01311713|"     CEP-9722 is an inhibitor of poly-adenosine diphosphate (ADP) ribose polymerase -1 and -2     (PARP). The primary purpose of this study is to (Part 1) determine the maximum tolerated dose     (MTD) of CEP-9722 administered daily to patients with advanced or metastatic solid tumors,     (Part 2) to evaluate the safety and tolerability of that dose, and to investigate whether     CEP-9722 has antitumor activity as a single agent.   "
150672|NCT01311700|"     The purpose of this study is to test whether early pre-reperfusion metoprolol administration     in patients suffering and acute myocardial infarction might reduce the size of myocardial     necrosis.   "
150673|NCT01311687|"     The purpose of this study is to compare efficacy and safety of pomalidomide in combination     with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or     relapsed and refractory multiple myeloma.   "
150641|NCT01312129|"     The overarching objective of this pilot study is to apply both neuroimaging and     pharmacogenetic tools to the study of alcohol dependence. This proposed research will provide     a mechanistic test of the function of the genetic variation. The specific aims and hypotheses     are to test whether Sulfasalazine, as compared to placebo, diminishes blood-oxygen-level     dependent (BOLD) response to alcohol cues in the striatum and prefrontal cortex (PFC). To     test the hypothesis, we will compare Sulfasalazine treatment with placebo treatment on BOLD     difference maps for the contrast alcohol minus control. We will also explore whether specific     genetic variations influence this effect. A double-blind, placebo-controlled 2 (Medication:     Sulfasalazine 1500 mg vs. placebo control) x 2 (Cue: Alcohol Cue vs. Control cue)     within-subjects, crossover design will be used to test the hypothesis that Sulfasalazine     reduces the BOLD response in the striatum and prefrontal cortex after exposure to alcohol     cues. Twenty alcohol-dependent participants will complete two rounds of the study medication     followed by an functional magnetic resonance imaging (fMRI) scan, during which they will     complete an alcohol cue-exposure task. The order of the medication condition will be     counterbalanced such that subjects will be randomly assigned to receive either Sulfasalazine     (1500 mg) in the first session and placebo in the second session one week later (or vice     versa). This pilot study will help to determine whether NMDA receptors play a role in     cue-elicited activation of key areas of the brain implicated in the development and     maintenance of substance use disorders. Furthermore, if Sulfasalazine reduces cue-elicited     activation of these brain regions, as hypothesized; this study will lay the groundwork for a     larger trial on the efficacy of Sulfasalazine as a treatment for substance use disorders.   "
150642|NCT01312116|"     The objective is to test if Internet-delivered cognitive behavior therapy (iCBT) or     Internet-delivered psychodynamic therapy (iPDT) performs better for a population with     generalized anxiety disorder (GAD), compared to a wait-list control condition.   "
150643|NCT01312103|"     The purpose for this trial is to test the effectiveness of the first interactive     internet-based safety decision aid on abused women's exposure to repeat intimate partner     violence (IPV) and mental health outcomes. An improved safety decision-making process (e.g.,     knowing the advantages and disadvantages of the relationship, having enough information to     make a decision) will increase safety-seeking behaviors which in turn will decrease exposure     to repeat IPV and improve mental health outcomes. Findings from the development and initial     test of our computerized safety decision aid suggests that it offered abused women privacy to     consider personalized safety options, informed them about danger in their relationship and     would be used again if they had access to it through a safe internet site.      The investigators are conducting a five year experimental trial in four states (Oregon,     Maryland, Missouri, and Arizona) to address the following aims:        1. Test the effectiveness of an interactive internet-based safety decision aid on abused          women's safety seeking behaviors and exposure to violence compared to women assigned to          control websites. The investigators hypothesize that at three, six, and 12 months          post-baseline the intervention group will have increased safety seeking behaviors and          reduced IPV exposure in comparison to the control group.        2. Test the effectiveness of an interactive internet-based safety decision aid on abused          women's mental health compared to women assigned to control websites. The investigators          hypothesize that at three, six, and 12 months post-baseline the intervention group will          have improved mental health in comparison to the control group.        3. Test if the effect of an interactive internet-based safety decision aid on abused          women's mental health and exposure to violence is mediated by the safety decision making          process and safety-seeking behaviors. The investigators hypothesize that the          intervention group will have a better decision making process and have greater safety          seeking behavior over the year in comparison to the control group, and that this better          decision process and increased safety seeking behavior will mediate improvement in          mental health and exposure to violence at 12 months post baseline.      This study will provide much needed new information about safety planning's impact on making     difficult safety decisions, exposure to violence, and mental health effects.   "
150644|NCT01312090|"     1. To test whether chronic intermittent cold exposure is more effective in programmed body          weight loss when compared to conventional programmed weight loss.        2. To measure the metabolic responses (e.g. in the white and brown adipose tissue, muscle          and circulating markers) of treatment with chronic intermittent cold exposure and          conventional treatment        3. To measure tissue specific changes of weight loss and the treatment with chronic          intermittent cold exposure in glucose uptake rate in adipose organ (white and brown          adipose tissue), liver, myocardium, skeletal muscle and brain        4. To measure tissue specific biochemical indicators before and after treatment with          chronic intermittent cold exposure from white adipose tissue and skeletal muscle.        5. To compare changes in body composition and fat distribution after weight loss using          chronic cold exposure or using conventional method   "
150645|NCT01312077|"     Total hip replacement is a major surgical procedure usually associated with significant pain     in the early postoperative period. In our hospital, total hip replacement is routinely     performed under spinal anaesthesia with intrathecal bupivacaine local anaesthetic plus opioid     in the form of preservative free morphine. The use of 'local infiltration analgesia' as an     alternative postoperative analgesic technique has been investigated.In this technique the     surgeon infiltrates the surgical site with a long-acting local anaesthetic and places a     catheter under direct vision which remains in situ and is used to administer local     anaesthetic in the postoperative period until such time as it is removed (when no longer     deemed necessary for pain relief or at a pre-set time in the postoperative period e.g. 48     hours). We hypothesize that infiltration of the surgical site with peri- and intraarticular     levobupivacaine local anaesthetic would be an efficacious pain management technique and would     not be inferior to intrathecal morphine for postoperative pain management.   "
150646|NCT01312064|"     The investigators hypothesized that everolimus-based immunosuppressive therapy combined with     rituximab induction could provide comparable safety profiles for renal transplant patients,     as compared to standard immunosuppressive therapy using thymoglobulin induction, tacrolimus,     mycophenolate mofetil and steroids, in terms of acute rejection rate and renal function.      Rituximab was reported to reverse refractory acute kidney transplant rejection. Combined with     immunoadsorption with or without IVIG, rituximab could successfully prevent antibody-mediated     rejection in ABO-incompatible renal transplantation. This study is to assess whether a     CNI-free regimen including B-cell depleting antibody induction, everolimus and MMF results in     comparable long-term function without a negative impact on safety or efficacy of     immunosuppression. This study will be open-label and two-arm randomized (2:1).   "
150647|NCT01312051|"     Blacks are at increased risk for obesity, type 2 diabetes mellitus and cardiovascular     disease. A common pathogenetic link among these entities is insulin     resistance/hyperinsulinemia.      The specific aims of this project are: 1) to compare skeletal muscle lipid content (SMLC) in     black vs white children by computed tomography (CT) scan of the mid-thigh, and assess the     relationship to in vivo insulin sensitivity; 2) to test the hypothesis that free fatty acid     (FFA) - induced insulin resistance is associated with larger increases in intramyocellular     lipid (IMCL) in black vs white adolescents; 3) to examine if β-cell insulin secretion in     prepubertal black children is more sensitive to the stimulatory effect of FFA than in whites;     and 4) to test if the β-cell in black obese adolescents is more susceptible to the lipotoxic     effect of FFA compared with whites. The methods to be used are: the well- established CT     method as well as Magnetic Resonance Spectroscopy (1H-MRS) to assess SMLC and IMCL;     intralipid infusion to elevate circulating FFA levels; the hyperinsulinemic-euglycemic clamp     with stable isotopes and indirect calorimetry to measure insulin sensitivity and substrate     turnover; the hyperglycemic clamp to assess insulin secretion; DEXA and whole body MRI for     body composition assessments.   "
150674|NCT01311674|"     The purpose of this study is to vaccinate plasmapheresis donors for collection of high titer     plasma to be used in the manufacture of Hepatitis B Immune Globulin (HBIG).   "
150726|NCT01310010|"     Study hypothesis:      Treatment with dasatinib 100 mg QD is safe and efficacious when given to patients with Ph+     ALL in the post SCT setting.   "
150648|NCT01312038|"     This study is designed to measure the effects of a chewable Simethicone tablet taken by mouth     on middle-ear pressure in adults with a common cold and evidence of abnormal middle-ear     pressure. In children and adults, middle-ear diseases such as otitis media (the buildup of     fluid within the middle ear) and a form of temporary hearing loss occur if the Eustachian     tube does not open, does not open often enough or is always open. Simethicone, available     over-the-counter under several brand names including Gas-X, may help break up the bubbles     that may block the opening of the Eustachian tube in the back of the nose during a cold,     allowing air to pass between the nose and middle ear. This study requires a single visit to     the Middle Ear Physiology Laboratory in the Oakland section of Pittsburgh. If eligible for     the study, Eustachian tube function testing will be done; the Simethicone tablet or placebo     (a tablet that looks and tastes like the Simethicone tablet but has no active ingredient)     will be given and Eustachian tube function testing repeated.   "
150649|NCT01312025|"     In conventional laparoscopic cholecystectomy, the cystic duct and artery are clipped by metal     clips. we propose a new method in which the cystic duct is ligated and the cystic artery is     cauterized. the investigators compare both methods.   "
150650|NCT01312012|"     Since the implementation of universal vaccination in 1984, the chronic HBV carier rate in our     general population reduced from 15-20%, down to < 1% in the post-vaccination population.     However, children born to HBeAg positive mothers still may be infected with HBV despite     immunization. To further reducing the HBV infection in our people, strategies in reducing     infection rate in this high risk group are mandatory. Previous small scale studies using     lamivudine treatment in pregnant woman in the third trimester has proved effective in     reducing children infection rate. The aims of the present study are to conduct a clinical     trial in using Tenofovir (category B) to reduce mother-to-infant transmission, and to monitor     the hepaitits B viral status and mother hepatitis occurrence. The clinical trials will screen     cases of HBsAg positive pregnant women aged 20 to 40 years at gestational at 20-32 weeks.     They will be tested for HBsAg and HBeAg. In whom both markers are positive, HBV viral load     will be tested. An estimated 180 pregnant women with high HBV viral load (>10^8 copies/mL)     will be recruited in the study; including 80-100 subjects treated with Tenofovir 300 mg daily     starting from 30-32 weeks of gestation (3rd trimester) and continued to 1 month after     delivery; and 80-100 pregnant women are enrolled as controls with no drug given to the     mother. The newborn babies are given with HBIG within 24 hours after delivery, and HBV     vaccines at 0, 1 and 6 months. Maternal complete blood count (CBC) data tested in the first     prenatal examination will be recorded. Plasma AST、ALT levels and HBV DNA are tested before     Tenofovir treatment, 1 month after treatment, at the time of delivery, and at 1, 2, 4 and 6     months after delivery. HBsAg、HBeAg、anti-HBs and AST、ALT are tested in the children at day 1,     6 moths and 1 year after birth. The primary outcome is reduction of the HBsAg carrier rate of     the children at 6 months of age. The secondary outcome is HBsAg carrier rate of the children     at 12 months of age, the change of liver function, HBeAg, and viral load in pregnant mother     after treatment.      A follow-up study for investigating safety of mothers and children that has been exposed to     maternal tenofovir disoproxil fumarate (TDF) during pregnancy in reducing mother-to-infant     hepatitis B virus (HBV) transmissions is conducted. The follow-up study included     mother-children pairs 2-4 years after delivery of the children.   "
150651|NCT01311999|"     To follow-up the latent tuberculosis infection and the risk of developing active tuberculosis     in patients receiving long-term dialysis   "
150652|NCT01311986|"     The aim of this study is to measure the serum levels of CCL17, CCL18, CCL22 and CXCL10 and     their expression levels in epidermis in AD and ND patients.   "
150653|NCT01311973|"     The specific purpose of this study is to describe the relationship between salivary     phosphorus and kidney function, specifically as it relates to serum phosphorus, FGF23, PTH,     vitamin D status and urinary excretion of phosphorus.   "
150654|NCT01311960|"     The purpose of this study is to determine whether bevacizumab eye drop is effective in the     treatment of recurrent pterygium.   "
150655|NCT01311947|"     In order to clarify the association between HBV mutations appearing before and during     interferon therapy and the therapeutic effects, serial serum samples from 100 HBeAg-positive     CHB patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the     mutations of preS/S gene and BCP-preC/C region, particularly for the deletion mutations.     Furthermore, Real-Time PCR will be performed to measure the ratios of wild-type HBV and     deletion mutant HBV before and at the end of peginterferon alfa-2a therapy. Finally,     statistical analysis will be done to elucidate whether the mutations of preS/S gene and     BCP-preC/C region have any relation with the therapeutic effect of peginterferon alfa-2a.   "
150656|NCT01311934|"     The acoustic radiation force impulse (ARFI) technology provides real-time measurements of     tissue stiffness.      Aim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation     and validity studies between visceral ARFI quantification and the referenced Metavir fibrosis     scoring and to conduct subsequent innovative studies on liver diseases.   "
150657|NCT01311921|"     EV71 has caused large epidemics with lots of fatal cases and cases with sequelae. However,     the clinical syndromes and severity of the same EV71 strain are very diverse, ranging from     asymptomatic (71%) to fatal (0.05%) disease, and the pathogenesis remains unknown. In     addition, the severe or fatal case incidence varies significantly differently in different     areas of Taiwan. Although some viral virulence studies were performed, no clear viral     virulence factor has been found. Therefore, host factors may be important to the clinical     outcomes of EV71 infections. In addition, there were significantly different incidences of     severe or fatal cases in different areas of Taiwan, for example, significantly more fatal or     severe cases occurred in the central or southern Taiwan in comparison with in northern     Taiwan. Whether this is related to host factors, social, behavioral or environmental factors     remains unanswered. To find the most important factors associated with EV71 susceptibility, a     thorough study involving genetics, social, behavioral or environmental factors among     different areas of Taiwan is warranted and the findings will provide future prevention of     EV71 and give help on early precaution and treatment of EV71.   "
150658|NCT01311908|"     Reflux esophagitis is a common complication following distal gastrectomy. According to the     investigators preliminary data, an Roux-en--Y gastrointestinal reconstruction in     pancreaticoduodenectomy is associated with higher rates of reflux esophagitis. In this study,     the investigators will investigate the incidence of reflux esophagitis after above procedure     by the 24-h pH monitoring of esophagogastric junction.   "
150659|NCT01311895|"     The purpose of this study is to compare two opioid protocols (H2O and 1+1) for the     treatment of acute severe pain in the emergency department. The investigators primary     hypothesis is that the H2O protocol will be more efficacious than the 1+1 protocol in     Emergency Department patients aged 21-64 years. The primary outcome is the proportion of     patients in each arm who choose to forgo additional pain medication at 60 minutes.   "
150660|NCT01311882|"     This is a study to evaluate next-day residual effects of MK-4305 on highway driving     performance in healthy, non-elderly participants.   "
157699|NCT01219504|"     To assess the impact of embryo biopsy on the reproductive potential of human embryos.   "
150661|NCT01311869|"     Uterine Leiomyomata, also known as uterine fibroids, are non-cancer tumors found in the wall     of the uterus or womb. Uterine fibroids are the common cause of surgery (removal of the     uterus). African American women are 3-4 times more likely to have uterine fibroids. Currently     there is no effective long-term medical treatment for fibroids. Hormones have been used for     short-term therapy, but they are not used long-term because of the risk of side effects. When     women stop receiving the hormone therapy often fibroids return. Surgery is the common     treatment for women who are suffering from abnormal symptoms caused by fibroids. Hysterectomy     is an effective treatment, however women cannot have children after removal of the uterus.      Epigallocatechin Gallate (EGCG) is one of the main natural chemicals found in green tea..     Research the investigators have done in the laboratory and in animals leads them to believe     EGCG may decrease the growth of fibroids.      This study is intended to determine whether EGCG will cause fibroid tumors to shrink and     reduce fibroid related symptoms such as abnormal vaginal bleeding and pelvic discomfort.   "
150662|NCT01311856|"     The goal of this behavioral research study is to learn if an internet or phone based exercise     and weight management program can help cancer survivors to lose weight and change their     eating and exercise behavior.   "
150663|NCT01311830|"     This study will develop an intervention for adults who want to support a smoker. The goal of     the intervention is for the support person to motivate & encourage their smoker to call the     state Quitline funded by Minnesota ClearWay. The study will examine the efficacy of a     telephone based intervention for support persons compared to a self-help intervention     (written materials only).   "
150664|NCT01311817|"     This project is a pilot safety and immunogenicity study of transcutaneous vaccination with     live attenuated Listeria monocytogenes BMB72 bacteria (actA/plcB-deleted, expressing     influenza A nucleoprotein) and a cutaneous adjuvant, native purified cholera toxin.     Transcutaneous vaccination is needle-less application of materials directly to the skin.     Healthy adult volunteers (4 per group) will receive either:        -  Saline (placebo)        -  Cholera toxin adjuvant alone        -  L. monocytogenes BMB72 bacteria alone        -  L. monocytogenes BMB72 bacteria plus Cholera toxin adjuvant      Vaccine solutions will be applied to the upper deltoid area under a standard Tegaderm     dressing. Key primary endpoints include: safety as measured primarily by clinical findings     (VS, cutaneous exams, and systemic reactions), and immune responses as measured by     serological responses to L. monocytogenes, influenza A nucleoprotein, CT, and IFN gamma     ELISPOT responses to listeriolysin and nucleoprotein peptides. Local skin immune responses     will be evaluated by skin biopsy in subjects who agree to that (optional). The study will     begin with 2 roll-in subjects receiving both L. monocytogenes and CT.   "
150665|NCT01311804|"     Primary Research Objective:      The primary objective of this study is to determine efficacy of periarticular parecoxib     sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management     in total knee arthroplasty      Secondary Research Objective:        -  To determine if perioperative use of parecoxib sodium was associated with improved          clinical outcomes        -  To evaluate the safety, in terms of adverse events; serious adverse events and          tolerability of parecoxib sodium in periarticular injections in a multimodal cocktail   "
150666|NCT01311791|"     This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The     purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular     augmentation and restoration in patients with dilated cardiomyopathy. Algisyl-LVR™ will be     injected into the myocardium under direct visualization during the surgical procedure.      This study will evaluate the concept that direct mid left ventricular (LV) intramyocardial     injections of Alginate hydrogel implants into the free wall of the failing LV will reduce LV     size, restore LV shape, lower LV wall stress and improve global LV function.      The Primary Efficacy Endpoint of the study is the change in Peak VO2 (maximum oxygen uptake)     from baseline to 6 months of follow-up. The Primary Safety Endpoint of the study is to     estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device      The hypothesis of the study is that there is a statistically significant difference in change     in Peak VO2 from baseline to 6 month follow-up when the medically managed arm is compared to     the Algisyl-LVR arm, i.e. the Algisyl LVR arm is superior to medical management.   "
150667|NCT01311778|"     Despite the current available therapies for opioid-dependent patients, most patients relapse.     This research project focuses on the development of a novel compound, cannabidiol, to     modulate opioid craving in humans based on animal models showing its selective effectiveness     to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse     would be of tremendous medical and public health value.   "
150668|NCT01311765|"     The investigators purpose is to demonstrate that a short antibiotic therapy (8 days) for     postoperative peritonitis brings an increased number of antibiotic-free days over a 28 days     period when compared to conventional (15 days) treatment.   "
150669|NCT01311752|"     This study is a Multicentre cohort study with inclusion throughout the full duration of the     study.      The primary objective is the study of human papillomavirus related genital pathology in HIV     positive women.      The secondary objective are:        1. To study the characteristics of HPV infection and related disease in the context of long          term HAART and HIV infection ;        2. To study the characteristics of atypical cells of uncertain significance detected in Pap          smears, whose prevalence has dramatically increased in the last years;        3. To describe cervical cancers observed in the cohort        4. To study the evolution of recurrent high-grade lesions after surgery        5. To describe the evolution of vaginal lesions developed after hysterectomy for high-grade          lesions ;        6. To describe the specific aspects of surgery for the treatment of cervical lesions          according to the specific localization in the endocervix in HIV-positive women ;        7. To study the in situ T cell HPV specific response in cervical lesions and the          relationship between virological and clinical parameters, host immune status and natural          history of lesions ;        8. To initiate a prospective study on anal HPV infection and related disease among women          infected with HIV.        9. To initiate a study on therapeutic and/or prophylactic HPV vaccines in the context of          immunosuppression and a high rate of HPV infection ;   "
150675|NCT01311661|"     This study will compare efficacy and safety of different regimens of olodaterol     administration in asthma (once daily, twice daily) with placebo in a complete cross-over     design each within one of the two daily dose groups (medium or high daily dose).   "
150680|NCT01311596|"     This cohort observation, randomized controlled trial is intended to provide data that icons     and non-verbal communication improve communication and cooperation with children with     Autism/communication delay and aid in the transition to an unfamiliar environment. It would     lay the foundation for future studies and practices of using icons and pictures for the whole     office visit to enhance communication between the patient and physician/nurse/medical staff     and cooperation of the patient.        1. Use icons during triage/check in process to decrease time and increase patient          compliance. Compare typical children to those with Autism/communication delay.        2. Use icons during blood draw to improve communication with patients, to help with patient          understanding, and increase patient cooperation and decrease noise and length of          procedure.   "
150681|NCT01311583|"     Patient education using Teach Back has the potential to increase self-care behaviour in heart     failure (HF) patients and reduce adverse clinical outcomes. Teach back is an interactive     teaching method that uses plain language, focuses on key points, and asks the patient to     verbally recall information just discussed. Questions are asked to confirm patient     understanding of the information delivered.      This pilot study will be conducted to evaluate the effectiveness of teach back on self-care     (as measured by the European Heart Failure Self-Care Behaviour Scale- EHFScBS) and determine     if teach back affects the number of ER visits and re-admissions post discharge. The study     will also assess if teach back technique is a feasible, acceptable and sustainable method of     discharge teaching for hospitalized HF patients at St Michael's.   "
150682|NCT01311570|"     The primary objective of this study is to assess the therapeutic effect of Buprenorphine in     MDD population.      The secondary objectives of this study are to assess the therapeutic effect, the feasibility     and safety of buprenorphine in a MDD population.   "
150683|NCT01311557|"     The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced     Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10     years of age.      Primary Objectives:        -  To compare pertussis antibody responses induced by Adacel® in persons 10 to <11 years of          age to those induced by Adacel in persons 11 to <12 years of age.        -  To compare the booster responses against pertussis antigens induced by Adacel in persons          10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.        -  To compare booster responses against tetanus and diphtheria induced by Adacel in persons          10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.      Secondary Objective:        -  To compare seroprotection rates against tetanus and diphtheria induced by Adacel in          persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of          age.   "
150684|NCT01311544|"     The Magnetic Resonance angiography (MRA) of supraaortic vessels is essential for the     etiologic of stroke. However, the techniques usually used provide only static evaluation     (degree of stenosis, occlusion) but not dynamic. An ultra-fast 3D MRA originally developed     for the cardiac imaging, k-t blast (Broad-use Linear Acquisition Speed-up Technique) could be     used to review the supraaortic vessels. This MRA offers the following advantages: short     acquisition time, wide spatial coverage (of the thoracic aorta to the distal encephalic     arteries), 3D spatial resolution and high temporal resolution. These qualities are even more     optimal with a high magnetic field (3T). The high temporal resolution is interesting because     it provides to repeat a volume every eight seconds and thus to have a dynamic evaluation of     vascular filling and to assess the vascular supply of the infarcted territory. This sequence     is classified as a 4D MRA.   "
150685|NCT01311531|"     The treatment of unstable, non-reducible distal radial fractures is still controversial. The     aim of the present study is to compare the subjective, clinical and radiographic outcome of     the TriMed fragment-specific system with a volar locking plate in patients with unstable,     non-reducible and also redislocated distal radial fractures.   "
150686|NCT01311518|"     The objective of this study is to evaluate the safety and tolerability of two active doses of     RGN-352 (thymosin beta 4, Tβ4, Injectable Solution) in patients with acute myocardial     infarction receiving percutaneous coronary intervention angioplasty with or without stent     placement. Approximately 75 subjects will be randomized to receive one of two RGN-352 doses     of 1200 mg, or 450 mg, or placebo, administered iv by iv push daily for the first 3     consecutive days and weekly for 4 more weeks.   "
150687|NCT01311505|"     This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2     Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer     Inc) with equivalent dose of the reference Rimactane® capsule (each contains 300 mg     rifampicin, Novartis Sandoz) in healthy Filipino male subjects. This study also aims to     determine the safety and tolerability of Myrin© 2 tablets and Rimactane® capsules in these     subjects.   "
150688|NCT01311492|"     Exercise Trial for Alzheimer's Disease(EXTRA) is a pilot randomized clinical trial involving     a physcial activity program versus a healthy lifestyle program, with one year follow-up in 30     non-disabled, community-dwelling persons, age 65 and older.   "
150689|NCT01311479|"     The proposed study will evaluate the effectiveness of Osteopathic manipulation of the     sacro-iliac joint (SIJ) and the lumbar spine in symptomatic female interstitial cystitis (IC)     patients with sacro-iliac joint dysfunction.      It is predicted that Osteopathic manipulation for a period of 12 weeks will result in     subjective indices of increased comfort and objective indices of lower O'Leary-Sant     Questionnaire, Pelvic Floor Impact Questionnaire (PIFQ-7), Female Sexual Function Index     (FSFI) and SF-12 scores, lower visual analog scores for pain and urgency, decreased frequency     on voiding diary and greater variation in resting/contraction perineometry scores.   "
150690|NCT01311466|"     Patients with uveal malignatnt melanoma with liver metastases have a dismal prognosis with a     median survival of less than 12 months. There is noe established treatment showing increased     overall survival. In this study we will determin if liver transplantation will result in long     term survival in patients with liver only metastases from uveal malignant melanoma.   "
150691|NCT01311440|"     In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat     children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a     treatment option for children up to 18 years.      We now initiate an open, prospective, randomized and controlled study with the aim to test     the efficacy of treatment with modified Atkins diet in adults with focal and generalized     epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients     on a permanent basis.   "
150693|NCT01311414|"     During clamping of one internal carotid artery for endarterectomy, blood flow through this     vessel has to be compensated by collateral arteries including the contralateral internal     artery and vertebral arteries. In 7 % of all patients undergoing carotid endarterectomy this     collateral flow is not sufficient to maintain adequate cerebral perfusion during clamping and     ischemic brain damage is likely to emerge. To maximize cerebral blood flow during clamping,     increase of blood pressure is a common procedure and routine at our institution. Increasing     blood pressure can be enabled by tapering a mixture of Cafedrine und Theodrenalin (Akrinor®)     until the designated blood pressure is reached. After declamping, the blood pressure has to     be reduced to normal values to avoid postoperative hyperperfusion syndrome. This is enabled     by tapering urapidil until normal blood pressure is achieved.      It has been shown that cerebral oxygenation measured by near infrared spectroscopy is reduced     by intravenous application of norepinephrine. Otherwise, intravenous nitroglycerine increases     cerebral oxygenation during cardiopulmonary bypass. Hence, cafedrine/theodrenalin and     urapidil may also have an effect on cerebral perfusion. In this prospective randomized study     the effect of cafedrine/theodrenalin and urapidil on cerebral oxygenation measured by near     infrared spectroscopy is investigated.   "
150694|NCT01311401|"     The aim      The aim of the present study is:        1. The metabolic risk factors that can predict diabetes after 10 years in a Circassians          population-based sample of people who were aged 35 years or older and living in Israel.        2. To define the incidence of type 2 diabetes mellitus in Circassians minority in Israel.      The hypothesis of the study:      High fasting glucose has the most powerful predictive value for type 2 diabetes mellitus in     the future.      The claimed importance of the study:      Finding a powerful risk factor for future diabetes mellitus can contribute to intensifying     the preventive measures in a small part of the population, by that to reduce the incidence of     new diabetes without increasing the health cost.   "
150695|NCT01311388|"     The investigators want to achieve the goal of diagnosis in early phase, accurate treatment     and existence for a long period in order to screen in early phase, diagnose in clinical     trial, choose treatment and evaluate prognosis of cancers by establishing molecular pathology     tools.   "
150696|NCT01311375|"     The objective of this study is to evaluate the effect of omega 3 fatty acid on neurological     recovery, lipid profile and Antioxidant system in patients with spinal cord injury. One     hundred spinal cord injured patients who come to clinic of spinal injury repair research     center selected. Then the patients will receive two supplements capsules of omega 3 (600 mg)     in the intervention group and placebo in the control group. Primary outcome measures are     professionals evaluation of neurological function by using :        -  ASIA scale for sensory and motor function        -  FIM scale for Functional potential        -  FAM        -  SF_36 for quality of life      Lipid profile and Antioxidant profile evaluation by using:        -  FBS        -  2hpp        -  Insulin        -  LDL        -  Total cHOL        -  TG        -  HDL        -  Leptin Adiponectin -Calcium-        -  25OHD        -  PTH,LH, FSH, Prolactin,Testosterone in males Bone markers by serum levels of          :Osteocalcin-Osteoprotegrin_Bone Specified ALP- CTX - RANKL        -  BMD   "
150697|NCT01311362|"     The aim of the present study is to assess the impact of CYP3A4-induction by SJW on steady     state ambrisentan and the impact of the cytochrome P450 2C19 (CYP2C19) genotype (*2 and *3     allele vs. wild type; ~2-5% poor metabolisers in Caucasian population) on the     pharmacokinetics of ambrisentan in healthy volunteers.   "
150698|NCT01311349|"     Various bacterial organisms will be tested in order to compile information regarding the     effectiveness of tigecycline against certain bacteria seen in local communities.   "
150699|NCT01311336|"     The purpose of this study is to determine the incidence of pegfilgrastim-induced back and leg     pain and to determine whether the antihistamine loratadine can prevent pegfilgrastim-induced     back and leg pain.   "
150700|NCT01311323|"     MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary     artery disease and/or with left main narrowing who present symptoms of acute ischemia. For     such kind of patients according to current ACC/AHA guidelines CABG (surgical     revascularization) is recommended as a treatment method. In comparison with CABG, recent     studies have shown that PCI (percutaneous coronary intervention) is associated with a lower     rate of periprocedural adverse events and similar long term event-free survival in patients     with left main disease. Our latest non randomized registry and randomized LEMANS study,     comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings.     LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA     (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward     lower one year mortality after PCI when compared with CABG. It should be stressed, that acute     ischemia substantially increase the risk of CABG. In fact, there are limited data on the     outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS).      Similarly, all randomized studies comparing PCI vs CABG in multivessel disease included     mainly patients with stable angina, small cohort of patients with unstable angina and they     excluded patients with non ST elevation Myocardial infarction.      In the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low     perioperative risk (logistic EUROSCORE <5) and ACS patients routinely excluded. High     perioperative risk patients were included only in PCI registry.   "
150701|NCT01311310|"     This study is conducted in order to evaluate the effect of remote ischemic preconditioning on     children undergoing cardiac surgery, especially focusing on possible differences according to     preoperative cyanosis.   "
150702|NCT01311297|"     A single- center prospective observational study. This study evaluates different aspects of     endothelial function. It investigates the endothelial leakage with the venous occlusion     plethysmography and the flow-mediated vasodilatation by ischaemia reperfusion testing.   "
150703|NCT01311284|"     Nasotracheal intubation is usually required in oral surgery to allow an unrestricted surgical     approach. The standard method is generally performed using the Macintosh laryngoscope     supported by Magill forceps. However, it is recommended to perform awake tracheal intubation     in situations where a difficult airway is predicted, a scenario where this technique may be     poorly tolerated by the patient. Although fibreoptic intubation is considered the gold     standard, sometimes it is difficult to perform and,therefore, alternatives are necessary.     The hypothesis is that optical laryngoscopes as the Airtraq nasotracheal and Mcgrath can     improve the time and/or success of nasotracheal intubation in a manikin.   "
150706|NCT01311245|"     The aim of the randomized controlled trial was to test two behavioral interventions among     job-seekers with risky drinking. The interventions differed in their theoretical background:     Intervention A was tailored to the stage of change, and Intervention B was     non-stage-tailored. Over 12 months, job-seekers were pro-actively screened for risky drinking     at three job-agencies. Job-seekers with risky drinking were asked to participate in the     study. All three groups were assessed at baseline, and 3, 6 and 15 months later. The baseline     assessment was self-administered using handheld computers. The follow-up assessments by     interviews on the phone, primarily. Both intervention groups received individualized computer     generated feedback letters at baseline and 3 months later.   "
150707|NCT01311232|"     This study is a retrospective analysis to identify factors influencing hepatitis B virus     reactivation in patients treated with rituximab containing chemotherapy. Rituximab monoclonal     antibody targeting CD20 induces B-cell depletion resulting in prolonged immune suppression.     This leads to frequent reactivation of patients with a previous history of exposure to HBV or     HBV carrier.      We collect the clinical features and laboratory findings of patients satisfied the inclusion     criteria as follows.        1. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or \ follicular B-cell          lymphoma (FL).        2. Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a          primary treatment        3. Patients with a history of previous exposure to HBV             -  HBV surface antigen (HBs Ag) positive Or             -  HBV core antibody (IgG anti-HBc antibody) positive      Then, we compare the HBV reactivation group with the control group (HBV reactivation does not     happen) to find factors influencing HBV reactivation.   "
150708|NCT01311219|"     Patients with acute, displaced fractures of the middle third of the clavicle will be randomly     assigned into either the non-operative treatment group or the operative treatment group. The     operative treatment group will be randomly assigned to repair with either an intramedullary     device or a plate and screws.   "
150709|NCT01311206|"     The objective of the proposed research is to assess the efficacy of an eight-week, efficient     and tolerable, low-intensity resistance-training program with concurrent application of     partial blood flow restriction (PBFR) for improving quadriceps strength and volume in women     with risk factors for incident symptomatic or progressive knee OA. This specific aim will be     achieved through a randomized, controlled trial, comparing low intensity training with and     without PBFR. There have been numerous reports of exercise interventions in people with knee     osteoarthritis. However, this research is novel in that it will be the first to use a low     intensity regimen that will minimize forces on the knee while still having the potential to     lead to clinically meaningful strength gains in older adults with risk factors for incident     symptomatic or progressive knee OA.   "
150710|NCT01311193|"     Individuals with borderline personality disorder (BPD) frequently suffer from emotional     instability, daytime fatigue and sleep disturbances. The investigators examined circadian     rhythms, sleep and well-being in women with BPD under their habitual life conditions with and     without light treatment.      Treated women diagnosed with BPD were investigated during 3 weeks without and 3 weeks with     morning LT. Rest-activity cycles were continuously measured using wrist actigraphy, together     with proximal skin temperature. Saliva samples were collected weekly to determine the diurnal     melatonin rhythm. A range of self-ratings and questionnaires were used to assess depression     and clinical state throughout the 6-week protocol. Ten matched healthy women followed the     same 6-week protocol without light treatment.   "
150711|NCT01311180|"     Sensoril - Extracts of Withania somnifera (Ashwagandha in Ayurvedic Medicine) have shown     potent anti-stress, cortisol lowering, GABAergic, serotonergic and antioxidant properties in     animal and human studies. Furthermore, controlled, single site human studies have shown the     anxiolytic potential of WS extracts.The present study is a Phase II Double-Blind, Parallel     Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients with     Generalized Anxiety Disorder. The primary objectives of this study are to assess the efficacy     and safety of Sensoril® for patients with moderate or greater severity of symptoms associated     with Generalized Anxiety Disorder.      The Primary Efficacy endpoint in this study will be determined by a statistically     significantly greater improvement from baseline to endpoint in total Hamilton Anxiety Scale     scores in the Sensoril® treated group versus those receiving placebo.      The secondary endpoints in this study will assess if Sensoril® treatment rather than placebo     results in:        1. Greater response rates (≥ 50% improvement in HAM-A total scores from baseline to last          value)        2. Greater remission rates (HAM-A total scores ≤ 7) at week 8        3. Greater improvement from baseline to week 8 in HAM -A psychic and somatic anxiety          cluster scores.        4. Greater improvements on CGI - severity scores from baseline to last value.        5. A higher percentage of subjects rated as much improved or very much improved on the          CGI - Improvement subscale at the last value.        6. Serum cortisol and DHEA-S levels will be assessed between the two treatment groups.          These biomarkers are indices of stress and it is hypothesized that improvement in levels          of these stress indices will favor the Sensoril® treated group.      Exploratory Endpoint      1. Patient reported outcomes for sleep and calmness will be assessed between the two     treatments.      Safety Endpoint      The safety endpoints will be determined by assessments of adverse and serious adverse events,     physical examination, vital signs, EKG, and clinical laboratory measures. Clinical measures     with laboratory defined reference ranges and vital signs will be assessed.   "
150712|NCT01311167|"     Accumulation of salt and water in patients with liver disease (so called liver cirrhosis) is     possibly related to the increased effect of steroid hormones on salt reabsorption in the     kidney. By reducing overall steroid production with the dexamethasone the accumulation of     salt and water could be prevented.   "
150727|NCT01309997|"     This randomized phase II trial is evaluating how well imatinib mesylate works compared to     rituximab in treating cutaneous sclerosis in patients with chronic graft- versus-host disease     (GVHD). Both imatinib and rituximab have been reported to decrease skin thickening and     improve skin and joint flexibility in people with cutaneous sclerosis due to chronic GVHD.   "
150732|NCT01309932|"     The purpose of this study is to determine if combination therapy with Pegylated Interferon     Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or     BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC)     compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48     weeks.   "
150733|NCT01309919|"     The purpose of the study is to determine the feasibility of placing the     levonorgestrel-releasing intrauterine system (LNG - IUS, Mirena®) post-delivery. The     investigators will gain information about complications at the time of placement; the     investigators will also examine the expulsion rate, side effects, bleeding patterns and     subject satisfaction at various time periods after insertion.   "
150734|NCT01309074|"     The aim of the study is to compare the safety & efficacy of sertraline (up to a dose of     200mg/day) & pregabalin (up to a dose of 300mg/day)for the treatment of symptoms of anxiety     in patients with epilepsy.   "
151713|NCT01297972|"     Mesenchymal stem cells have been tested in many autoimmune disorders with encouraging results     and may be an alternative to the treatment of immune-mediated severe acquired aplastic     anemia.   "
150713|NCT01311154|"     The proposed study is distinctive in studying known carriers of resistant Enterobacteriaceae.     It examines both phenotypic and genotypic expansion in the AMR bacterial population as a     function of antibiotic treatment, and examines the effect of antibiotics on the dissemination     of resistance genes from species to species. It will examine CRE, important emerging     pathogens, which are a significant threat to public health, but yet not well studied. The     proposed study will use an interdisciplinary approach, combining PK/PD, phenotypic, and     genetic data to understand the effect of antibiotics on the likelihood of spread of AMR. Most     previous studies have focused on the effect of antibiotic agents on clinical detection,     infection or acquisition of AMR among non-carriers67,68. Other studies have looked at the     effects on colonisation-resistance mostly among healthy volunteers69. Very few studies have     examined the effects of various antibiotic agents on carriers of ARB and those focused     primarily on vancomycin resistant enterococci (VRE)70. No similar studies have been conducted     with regard to ESBL or to CRE. Correlation with clinical factors and environmental     contamination has not been determined in previously published studies. The proposed study     also extends the analysis to the effect of antibiotic treatment on dissemination of     resistance genes which may be of great importance as these events may lead to emergence of     new AMR strains and species. The proposed study not only examines the effects of various     antibiotic agents and classes, but also the effects of duration of treatment and PK/PD     indices on amplification of ARB. The study will also examine the effect of antibiotics on the     epidemicity and fitness of colonising strains   "
150714|NCT01311141|"     In the present study we will measure and compare the unbound, i.e. microbiologically active     concentrations of doripenem after a single dose of 500mg in plasma, subcutaneous adipose     tissue and muscle tissue and saliva of healthy volunteers. We will use the microdialysis     technique, which allows for the continuous measurement of unbound drug concentrations in the     interstitial space fluid. The findings of the present study will help to assess whether     currently employed therapy regimens with doripenem provide effective antimicrobial     concentrations in different compartments in man   "
150715|NCT01311128|"     This protocol will test a new non-invasive device, the T-line, in continuously determining     heart rate and blood pressure in operative and critically ill patients. The accuracy of the     device will be compared to the standard radial artery catheter, as well as to the     non-invasive blood pressure cuff. The T-line will also be compared to the right heart     catheter determining cardiac output in at least 20 patients.      Hypothesis: the T-line device will determine blood pressure and heart rate as accurately as a     standard radial arterial catheter and a blood pressure cuff in perioperative patients.   "
150716|NCT01311115|"     This study proposes a novel behavioral intervention to help smokers in Thailand to achieve     their goals of quitting. Smoking treatment programs are rare throughout most of Asia and     unlikely to meet the impending demand for quitting that tobacco control regulations is     stimulating. New approaches are needed.      The present study is a randomized controlled trial to test the effectiveness of a novel,     scalable approach to smoking cessation that is targeted toward rural Southeast Asian     communities. Thailand is used as a test case to explore if pairs of smokers quit successfully     after making financially-backed commitments and receiving cash incentives to quit. The     control group receives education and counseling about quitting. In addition to education and     counseling about quitting, the intervention includes two key components:        1. Each participant is encouraged to deposit his cigarette money on a weekly basis, to be          returned only if the smoker quits successfully within three months. Such commitment          contracts, based on theory from behavioral economics, are designed to help a person to          maintain self-control and motivation in the face of temptation.        2. Each participant is paired with another study participant. If both quit, each receives a          cash bonus. The joint incentives are designed to lead partners to support each other          throughout the quit attempt.      Thus, group commitment contracts marshal a robust blend of elements: financial commitment,     social support, peer pressure, and monetary rewards. A larger, follow-up evaluation will     clarify the relative importance of each of these elements.   "
150717|NCT01311102|"     The study hypothesis is that infusion of 2% lidocaine at the time of IUD placement will     reduce pain scores related to that procedure. In a double blinded randomized trial of 60     women receiving either normal saline or lidocaine infused through an endometrial aspirator,     pain scores will be obtained for each step of the IUD placement procedure and for the total     experience.   "
150718|NCT01311089|"     Most patients with thyroid tumors are effectively treated surgically by practitioners     experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing     thyroid surgery are concerned about the postoperative cosmetic appearance of the neck.     Robotic thyroidectomy which can hide the operative scar was associated with a higher degree     of patient cosmetic satisfaction.   "
150719|NCT01311076|"     The purpose of this study is to compare the safety, tolerability, pharmacokinetic and     pharmacodynamic properties of single doses of TAK-329 with a single dose of a     subcutaneously-injected rapid-acting insulin analog in participants with type 1 diabetes     mellitus.   "
150720|NCT01311050|"     A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with     Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer   "
150721|NCT01311037|"     The Combination of GnRh Analogue and Aromatase Inhibitor in Receptor Positive Premenopausal     Women with Advanced Breast Cancer A Prospective Trial.   "
150722|NCT01311024|"     The purpose of this study is to assess the indirect effects of a pneumococcal conjugate     vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7     years.   "
150723|NCT01310049|"     The purpose of this first-in-man trial is to determine the safety and tolerability of     ascending single and multiple doses of LEO 32731 in healthy male subjects. The trial will be     performed in three parts. In Part 1, single doses of LEO 32731 will be administered to     healthy male subjects. In Part 2, the effect of food on the single oral dose pharmacokinetic     will be investigated. In Part 3, multiple doses of LEO 32731 will be administered to healthy     male subjects.   "
150728|NCT01309984|"     The purpose of this study is to assess the transfer of fospropofol and its active metabolite,     propofol, to breast milk following administration of LUSEDRA® to lactating women undergoing a     needed procedure.   "
151755|NCT01297400|"     The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment     of subjects with partial thickness burns.   "
150735|NCT01309061|"     The purpose of this study is to investigate the efficacy and safety of autologous     transplantation of adipose tissue derived mesenchymal stem cells (MSCs) in patient with     progressive hemifacial atrophy.   "
150736|NCT01309048|"     This study is to confirm the safety and technical of MRI guided High Intensity Focused     Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases.      MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate     tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue.     The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be     performed in patients who pass inclusion/exclusion criteria.   "
150737|NCT01309035|"     Introduction:      Approximately 7000 total knee replacements (TKAs) are done every year. More than 90% of these     knee replacements are performed with the use of bone cement. Traditionally, a tourniquet has     been, used to reduce the bleeding during surgery, enabling surgeons to perform delicate     dissections in a bloodless operative field.      A tourniquet can be defined as a constricting or compressing device used to control     temporarily venous and arterial circulation to an extremity. Pressure is applied     circumferentially on the skin and underlying tissues of a limb. This pressure is transferred     to the walls of vessels, causing them to become occluded.      It is well known that applying a tourniquet for more than 1 to 2 hours is associated with a     number of disadvantages, for instance, severe pain and muscle effects during the first     postoperative day, thereby slowing rehabilitation.      Other side effects related to tourniquet use, include pulmonary embolus caused by venous     thrombosis and arterial thrombosis as a result of the dislodgement of an arterial plaque.     Furthermore, tourniquet-induced hypertension with general anaesthesia, muscle injury, a wide     spectrum of neurologic injuries, and tissue changes (Oedema compartment syndrome,     post-tourniquet syndrome) have been reported. An important fact is that bleeding affects the     quality of binding between bone and cement and thereby fixation of the knee prosthesis? Since     the introduction of modern cementing techniques, no previous clinical studies have     investigated the advantages or disadvantages of tourniquet use in knee replacement surgery.      Aims/hypothesis of the study:        1. To investigate the advantages and disadvantages of tourniquet use, including whether not          using a tourniquet reduces pain, facilitates mobilisation and recovery, and shortens          length of stay.        2. To study whether use of a tourniquet affects leg muscles during and after surgery, as          measured by with use of microdialysis to quantify level of ischemia .        3. To determine whether prosthesis fixation, measured by RSA, is affected by tourniquet          use. Because third generation cements secure prosthesis fixation, the investigators do          not expect to find any clinically significant migration (less than 2 mm) 2 years after          surgery.      Perspectives:      The investigators hope that the results of our study will improve rehabilitation regimes so     that patients will experience less pain after surgery and thus achieve more rapid     mobilisation and return to their daily lives.   "
150738|NCT01309022|"     The purpose of this protocol is to provide continued acess to immunosuppressive medications     to subjects from the completed/closed trial ITN005CT (NIS01,NCT00014911). THIS PROTOCOL DOES     NOT PROVIDE MEDICINES TO DIABETES PATIENTS WHO DID NOT PARTICIPATE IN ITN005CT.   "
150739|NCT01309009|"     This phase IIa study is designed as a multi-centre, single country, randomised, double-blind,     placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and     safety of Nepadutant given at two oral doses once daily for seven days in comparison to     placebo in the treatment of infantile colic.   "
150740|NCT01308996|"     The purpose of this study is to evaluate the INFUSE® Bone Graft as an alternative to     autograft for bone formation in the back of the mandible (lower jaw) prior to placing dental     implants.   "
150741|NCT01311011|"     Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with     Critical Limb Ischemia   "
150742|NCT01310998|"     The purpose of this study is to study the acute psychological effects in patients with     schizophrenia after one session of high intensity exercise.   "
150743|NCT01310985|"     A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam     Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized     (Non-Metastatic) Rectal Cancer   "
150744|NCT01310972|"     Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX   "
150745|NCT01310959|"     Establishing a Data Base for Aplastic Anemia and Other Marrow Failure Syndrome   "
150746|NCT01310946|"     Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology   "
150747|NCT01310933|"     The purpose of this study is to differentiate Kikuchi's disease and malignant lymphoma by     soft tissue ultrasound.   "
150748|NCT01310920|"     Evidence has been documented for the close relationship between the arrhythmia pathogenesis     and the gene expression in renin-angiotensin system. However, it remains unclear for     involvement of RAS in the pathogenesis of non-familial sick sinus syndrome. The researchers     thus investigated the possible relationship between non-familial sick sinus syndrome and the     polymorphism and haplotype of the AGT promoter.   "
150749|NCT01310907|"     Bradyarrhythmia, including sinus node dysfunction and atrioventricular block, is a major     cause necessitating pacemaker implantation. In contrast to familial bradyarrhythmia known as     by mutations at particular ion channels, limited information is available for the mechanistic     study in non-familial bradyarrhythmia.      Possible gene polymorphisms related to non-familial bradyarrhythmia were studied. Comparison     of multi-locus analysis and single-locus analysis will be analyzed between the cases and     controls. Functional studies will perform to clarify the results of association study.   "
150750|NCT01310894|"     The aims of this study are:        -  to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on          the rate of absence of definite cancer using patients on active surveillance as a          comparison (co-primary objective A) and        -  to determine the difference in rate of treatment failure associated with observed          progression of disease from low risk prostate cancer to moderate or higher risk prostate          cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance          (co-primary objective B).   "
155801|NCT01244516|"     The purpose of this study is to compare the clinical performance of three silicone hydrogel     contact lenses over a 2 week period.   "
150752|NCT01310868|"     RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     radiation therapy and temozolomide after surgery and Gliadel wafer may kill any tumor cells     that remain after surgery.      PURPOSE: This phase II trial is studying the side effects of fluorescence-guided surgery with     5-ALA given together with Gliadel wafer, followed by radiation therapy and temozolomide, in     treating patients with primary glioblastoma.   "
150790|NCT01310374|"     An observational clinical study will be performed in subjects aged 12-60 years old to     describe the dynamic changes of humoral immune/cellular immunity after vaccination of     influenza vaccine, and to discuss the role of different antibodies against influenza virus     infection, and to look for possible factors related to side effects with the vaccine.   "
150753|NCT01310855|"     RATIONALE: Cediranib Maleate and gefitinib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not     yet known whether cediranib maleate given together with gefitinib is more effective than     cediranib maleate given alone in treating patients with recurrent or progressive     glioblastoma.      PURPOSE: This randomized phase II trial is studying the side effects of giving cediranib     maleate together with gefitinib and to see how well it works compared with giving cediranib     maleate together with a placebo in treating patients with recurrent or progressive     glioblastoma.   "
150754|NCT01310842|"     The goal of this study is to learn about the influence of the social and physical environment     on smoking cessation (quitting smoking) among smokers.   "
150755|NCT01310829|"     The goal of this study is to evaluate a virtual reality-based intervention for training     health care providers who are not genetics specialists to effectively communicate with and     counsel patients regarding cancer genetics.   "
150756|NCT01310816|"     IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in     patients with Chondrosarcoma.   "
150757|NCT01310803|"     This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the     efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with     valrubicin following induction with valrubicin as compared to induction with valrubicin only     in subjects with CIS of the bladder. The randomization will be 1:1 and subjects will be     stratified by tumor type (CIS plus papillary disease vs. CIS only) and time from last     bacillus Calmette-Guerin (BCG) failure (>1 year vs. <1 year).   "
150758|NCT01310790|"     The impact of lactate guided therapy on septic shock has not been extensively investigated,     however the goal directed therapy has been used for years. The investigators aim was to test     the hypothesis that lactate directed hemodynamic therapy is associated with improving the     outcome of patients with septic shock by comparing different goal directed strategies which     have been commonly recommended clinically.      In this multicenter, randomized trial, the investigators assigned patients with septic shock     to three groups: Patients were treated with hemodynamic therapy directed either by     conventional parameters treatment (control group), or central venous oxygen saturation     (ScvO2), or blood lactate respectively in each group. The primary outcome was the rate of     death at 28 days after randomization and in-hospital mortality; secondary end points include     hemodynamic states, time to goal-achievement.   "
150759|NCT01310777|"     The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine     in lowering intraocular pressure (IOP) relative to each of its individual active components     in patients with open-angle glaucoma or ocular hypertension.   "
150760|NCT01310764|"     The purpose of this study is to investigate the safety and efficacy of bevacizumab as an     adjunctive treatment to trabeculectomy in open angle glaucoma patients and to compare this     new drug to the most commonly used anti-scarring agent, mitomycin C.   "
150761|NCT01310751|"     The aim of this study is to determine whether inhaled iloprost can be used to prevent and     treat PH and PHC while in children after operation of CHD   "
150762|NCT01310738|"     This study is aimed to compare the efficacy and safety of medications currently used in     Brazil for treatment of visceral leishmaniasis. The investigators will compare the effects of     meglumine antimoniate, two formulations of amphotericin B: deoxycholate and liposomal, and a     combination of meglumine plus the liposomal amphotericin B formulation. The study is designed     to demonstrate the difference in efficacy measured as cure rate at six months after treatment     and the safety profile based on the adverse event rate observed with each intervention.   "
150763|NCT01310725|"     The aim of the study is to evaluate the patency in different kinds of vessels used as graft     material in coronary artery bypass grafting.      The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the     same, or better, patency compared to radial grafts and that skeletonisation of the left     internal mammary artery does not effect the patency for this graft.   "
150764|NCT01310712|"     Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and     axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of     Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.   "
150765|NCT01310699|"     We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high     definition white light colonoscopy will detect an increased number of nonpolypoid (flat and     depressed) colorectal neoplasm.   "
150766|NCT01310686|"     To obtain a genotypic analysis of patients with chronic exudative age-related macular     degeneration noted to have subretinal or intraretinal edema despite continuous monthly     Anti-VEGF therapy.   "
150767|NCT01310673|"     Medical teaching suggests allopurinol should not be initiated in the setting of an acute     attack of gout, as rapid lowering of serum urate may exacerbate the attack. This study tests     the hypothesis that there is no difference in patient reported daily pain or flair     occurrences with early versus delayed institution of allopurinol during an acute gout attack.   "
150786|NCT01310426|"     Vaginal delivery may cause various levels of damage to the anal sphincter. According to the     literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal     delivery suffer from fecal incontinence. This has an adverse effect on the quality of life.     Different risk factors such as: first births, instrumental delivery, high birth weight,     prolonged second stage, epidural anesthesia etc. were assessed and found to be associated     with anal sphincter disruption. The purpose of this study is to assess risk factors for anal     sphincter disruption by new methods such as three-Dimensional transperineal ultrasound (3D     transperineal US).   "
150787|NCT01310413|"     This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate     vaccine GSK1557484A in children 6 months to < 18 years of age.   "
150791|NCT01310361|"     In some studies once daily amoxicillin therapy might be treatment of choice for Group A     β-hemolytic Streptococcus pharyngitis in comparison with three to four times daily treatment     with oral penicillin V.   "
151173|NCT01305083|"     This randomized, double blind, placebo controlled, multicentric, clinical study will assess     the efficacy and safety of Udenafil (100 mg) tablets in patients suffering from erectile     dysfunction(ED).   "
153756|NCT01271257|"     The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral     misoprostol.   "
150768|NCT01310660|"     Prospective studies to date have identified that the levator ani muscle injuries occur in     14-19% of women after vaginal delivery.      In none of studies a vaginal examination was performed at the time of delivery. It has     previously been shown that sonographic injuries of the anal sphincter that were believed to     be occult were in fact clinically apparent but not recognised at the time of delivery. It is     therefore important to correlate clinical findings to ultrasound images.      3D endovaginal endosonography has not previously been used to identify levator injuries. This     should potentially provide a better view of the pelvic floor muscles.      The relationship between levator injury and symptoms of pelvic floor dysfunction has not been     previously established using validated questionnaires. In this study, we include validated     questionnaires to evaluate urinary incontinence, faecal incontinence and vaginal symptoms. As     symptoms may become apparent only in the long term it is prudent that the women are followed     up in the long term.      The principle objective is to establish the incidence of levator muscle defects during     pregnancy and after childbirth. The levator muscle forms a major part of the pelvic floor and     damage to this muscle can potentially cause urinary, bowel and sexual problems and pelvic     organ prolapse.   "
150769|NCT01310647|"     The aim of this study is to compare the effectiveness of testosterone,estradiol and a     combined treatment with estrogens/progestagens prior to IVF-ICSI in previously diagnosed low     responder patients.   "
150770|NCT01310634|"     The overall goal of this project is to elucidate the epidemiology of anxiety and depression     in parents of hospitalized neonates and test a comprehensive intervention program to prevent     anxiety and depression in parents in this setting.   "
150771|NCT01310621|"     The purpose of this study is to evaluate the role of surfactant lung lavage in the treatment     of meconium aspiration syndrome. Aspiration of meconium into the tracheo-bronchial tree with     the onset of respiration results in meconium aspiration syndrome (MAS). Aspirated meconium     inhibits surfactant function directly and also decreases its synthesis by its toxic effects     on type 2 pneumocytes. There is no specific treatment recommended for meconium aspiration     syndrome. Numerous studies have shown that exogenous surfactant improves outcome in babies     with meconium aspiration. Surfactant replacement alone does not remove meconium from airways     and multiple doses may be required .Therefore an effective therapy to improve outcome is     crucial in treating infants with meconium aspiration. Surfactant Lung lavage has been shown     to be alternative to bolus therapy in treating neonates with meconium aspiration as shown by     many pilot studies. So the investigators have decided to study the role surfactant lung     lavage in the treatment of meconium aspiration syndrome.   "
150772|NCT01310608|"     Patients undergoing cardiac surgery frequently develop neurologic complications, ranging from     subtle cognitive changes to evident confusion, delirium, and stroke. This continuum of     complications is commonly caused by embolization in the brain due to manipulation of     atherosclerotic parts of the aorta ascendens (AA) during surgery. Timely detection of AA     atherosclerosis before surgery enables the surgeon to consider changes of the surgical plan,     to reduce the risk of embolization and thus subsequent neurologic complications.      Various methods exist to visualize the AA to detect atherosclerosis. Epiaortic ultrasound     scanning has become the gold standard, but is seldom used as it interferes often with     surgical plan and can only be used after sternotomy. Transesophageal echocardiography (TEE)     is a widely used imaging method permitting evaluation of the aorta preoperatively, but     assessment of distal AA is hampered by interposition of air-filled trachea between esophagus     and AA. The A-View® (Aortic-view) method, a modification of conventional TEE using a     fluidfilled balloon, overcomes this limitation. The safety and diagnostic accuracy of the     A-View® have successfully been shown in previous studies. The hypothesis of this study is     that the use of A-View will reduce cerebral embolization secondary to a change of surgical     technique.   "
150773|NCT01310595|"     To investigate the effect of cervical manual mobilization on head repositioning accuracy and     postural balance in patients with chronic mechanical neck pain in a randomized controlled     trial. Hypothesis: There is no difference between the intervention group (manual     mobilization) and control group head repositioning accuracy and postural balance.   "
150774|NCT01310582|"     Numerous studies demonstrate that patients have improved immediate recovery characteristics     following desflurane anesthesia compared to other volatile agents, including sevoflurane.     There is limited evidence in the literature to suggest that patients undergoing sevoflurane,     compared to desflurane anesthesia, may suffer from limitation in function and cognitive     ability for an undetermined, but prolonged period of time following surgery. These     differences are not explained pharmacokinetically and may be a result of a direct neurotoxic     effect of sevoflurane. An unresolved question is the time required for the ability to return     to complex tasks, such as driving, following anesthesia. Commonly, patients are advised not     to drive or make important decisions for 24 hours following anesthesia, but this is not     well-studied and proscribed on an empiric, rather than scientific, basis with very limited     data available.This study will better define recovery characteristics and characterize the     severity and duration of cognitive impairment following sevoflurane or desflurane anesthesia     after brief outpatient urologic surgery in elderly females using tests of cognitive ability     coupled with performance on a driving simulator and cognitive task tests to objectively     measure not only testing performance, but also cognitive effort in performing these tests.   "
150775|NCT01310569|"     This study aimed to search whether whole body and subcutaneous adipose tissues increase in     PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels.   "
150776|NCT01310556|"     This study aimed to examine the prevalence of glucose metabolism disorders (GMD)in the     patients with coronary artery disease and the relationship between different GMDs and     coronary artery disease (CAD).   "
150788|NCT01310400|"     A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal     V is as immunogenic as a locally sourced competitor vaccine in young children.   "
150789|NCT01310387|"     This study is:        -  A single-center, randomized, prospective controlled trial.        -  To prove superiority of active pain management group compared to control group by the          percent of pain intensity difference of outpatients with lung cancer pain.        -  204 patients will be recruited.   "
151168|NCT01305148|"     The WARFARIN Study is a clinical trial designed to determine if the use of genetic     information related to warfarin sensitivity can help create a dose of warfarin that will     result in less hospitalizations and deaths related to warfarin.   "
150777|NCT01310543|"     Teens and Toddlers is an intervention that enables young people at risk of teenage pregnancy     to spend time mentoring a toddler as well as participating in counselling and classroom work     focused on youth development. This trial aims to test primary hypotheses that girls age 13/14     who are randomly allocated to participate in the T&T intervention are more likely to report     use of contraception at last sex, less likely to report frequent sex without contraception     over the previous 3 months, less likely to expect to become teenage parents and more likely     to report high scores for youth development indicators one year after the intervention than     are similar girls who are randomised not to participate. The trial involves a total of 180     girls per arm and is being conducted across England funded by the Department for Education     and conducted by the London School of Hygiene and the National Centre for Social Research.   "
150778|NCT01310530|"     The purpose of this is to determine the efficacy and toxicity of proton therapy when used to     deliver partial breast radiotherapy in patients with early stage breast cancer with low or     intermediate risk factors.   "
150779|NCT01310517|"     The purpose of the study is to directly compare two methods of evaluating heart function at     the time of your angiogram. In both methods contrast dye is injected into the main heart     chamber during the angiogram while x-ray images are taken. One method uses an automatic power     injector to deliver the normal volume of contrast; the other method uses hand injection of     very low volume of contrast into the main heart chamber. It is hypothesized that hand     injection will prove to be an accurate method to estimate ejection fraction (EF) at the time     of radial coronary angiography when compared directly to Power LV.   "
150780|NCT01310504|"     Initially a group of paramedics will be trained to perform FAST (Focused Abdominal Scan for     Trauma) scans. The paramedics will then enter a simulated mass causality incident and triage     patients. Volunteers in the study will include peritoneal dialysis patients (non stable)     and non-peritoneal dialysis patients (stable). They will use the ultrasound to perform FAST     scans on the patients to determine which subjects are stable and which are unstable     patients. They will record which patients they consider need transport first. This data will     be used to evaluate accuracy and speed of the FAST scan. When the paramedic identifies free     fluid within the volunteer, they will be able to make the decision to upgrade these patients     and ultimately transport them more quickly. The paramedics will be evaluated for time and     accuracy with the FAST scan.   "
150781|NCT01310491|"     The purpose of this trial is to determine if by structured telephone based health coaching     programme supported by remote monitoring system among type 2 diabetes, coronary artery     disease and heart failure patients the investigators are able to improve their quality of     life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among     those type 2 diabetes patients who had elevated value of HbA1c when recruited.   "
150782|NCT01310478|"     To investigate safety and tolerance of dose-escalation of infusional recombinant human     endostatin in combination with mFOLFOX6 as initial therapy for patients with metastatic     colorectal cancer.   "
150783|NCT01310465|"     Many patients who have lumbar degenerative disease suffer from osteoporosis or reduced bone     mass or low bone mineral density. Among patients with lumbar degenerative disease, some need     fusion surgery. But conditions of osteoporosis or low bone mineral density slow down the rate     of bone fusion, reduce the success of bone fusion, and ultimately affect the overall     effectiveness of surgery. Zoledronic acid is an effective anti-osteoporotic. Many researchers     dispute if zoledronic acid can promote the healing of long bone fractures. But few     researchers focus on the effect of zoledronic acid to lumbar fusion. In this study, we select     patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. Three     days postoperatively, the patients were randomized to either one infusion of zoledronic acid     or sodium chloride intravenously. We follow all these patients for 6 months. During this     time, we detect bone metabolism and bone fusion of these patients. At last, we can tell if     zoledronic acid can modify bone metabolism and promote bone fusion.   "
150784|NCT01310452|"     Primary objective:      To compare the change in liver fat content and visceral fat mass (cm2) assessed by MRS     (Magnetic Resonance Spectroscopy) and MRI (Magnetic Resonance Image), after 26 weeks of     treatment with insulin detemir once daily or insulin NPH once daily both with metformin in     overweight and obese type 2 diabetic subjects.      Secondary objectives:      To compare the two treatments with respect to:        1. Efficacy:             -  MRI: abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous Adipose               Tissue Ratio.             -  Change in HbA1c from baseline at 12 and 26 weeks of treatment.             -  Change in Fasting plasma glucose from baseline at 12 and 26 weeks of treatment.             -  Weight             -  Waist and hip circumference        2. Safety:             -  Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus               NPH             -  Lipid profile at the start and after 26 weeks of treatment             -  Incidence of Adverse events during the trial             -  Safety profile as measured by laboratory safety parameters (haematology,               biochemistry) and physical examination/vital signs before and at the end of               treatment   "
150785|NCT01310439|"     The purpose of this study is to examine the neural basis of response inhibition, working     memory, and sustained attention in adolescents and adults with     Attention-Deficit/Hyperactivity Disorder (ADHD), with particular emphasis on quantifying the     effects of methylphenidate (i.e., treatment with psychostimulants) on neural function.     Participants will undergo electrophysiological measurement of brain function during     laboratory cognitive tasks. This research is aimed to develop a better understanding of how     ADHD neural dysfunction relates to clinical presentation and medication response during the     transition from adolescence to adulthood. The specific aims and hypotheses are:      Specific Aim: To characterize the effect of Ritalin (methylphenidate) on neural activity     underlying performance on the response inhibition task in ADHD adolescents and adults.     Hypothesis 1) Methylphendiate will increase N2 and P3 amplitude in ADHD persons during     medicated EEG sessions; Hypothesis 2) There will be a significant age × medication     interaction such that ADHD teens will show increased amplitude of N2 while medicated,     particularly at frontal sites, whereas ADHD adults will show differentially greater effect of     medication on P3 amplitude and latency at central sites. Hypothesis 3) Brain activity     assessed by fMRI will differ between unmedicated and medicated states.   "
152016|NCT01293981|"     The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor     Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.   "
150792|NCT01310348|"     The aim of this study is to investigate whether there is a relation between bone mineral     density of lower limbs exposed to vibration and the muscle strength gain in the knee     extensors and flexors, and a relation serum sclerostin level and the muscle strength gain in     the knee extensors and flexors in healthy young adult women.      Forty healthy young adult women are planned to include in this study. The participants     meeting the criteria were randomized into two groups: the training group (20 cases) and the     Control group (20 cases).      The whole-body vibration (WBV) training group will be trained on a WBV platform (Power Plate)     5 times a week for 4 weeks period. Participants will be asked to stand upright on WBV     platform. Training volume and training intensity will be low at the beginning but progressed     slowly according to the overload principle. The training volume will be increased     systematically over the 4-week training period. The training intensity will be increased by     increasing the amplitude (2-4 mm) and the frequency (40 Hz) of the vibration. The subjects     will be asked to report negative side effects or adverse reactions in their training diary.     In the Control group, sham stimulus will be performed by WBV platform 5 times a week for a 4     weeks period.      Plasma sclerostin level and, the right and left knee flexor and extensor muscles strength     will be measured before and after training period. Isokinetic torque will be measured with     the Biodex (Biodex System 3 PRO Multijoint System Biodex Medical Inc. Shirley/NY     USA)extremity-testing system. The right and left lower limbs bone mineral density (BMD) and     muscle strength will be measured before training period. The BMD will be evaluated by bone     densitometer (Norland XR-46 DXA, USA). Sclerostin levels will be measured by human sclerostin     ELISA kit.      The rest muscle electrical activity of right and left knee flexor and extensor muscles will     be evaluated at pre-vibration, post- vibration and, during vibration. The rest muscle     electrical activity will be measured by Powerlab (data acquisition system, ADInstruments,     Australia) device.   "
150793|NCT01310335|"     The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin     level in healthy young adult women.      Fifteen healthy young adult women are planned to include in this study. All cases will be     trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week     period. Training duration will be short at the beginning but progressed slowly.      The amplitude of vibration will be 2 mm and the frequency of the vibration will be 40 Hz. The     subjects will be asked to report negative side effects or adverse reactions in their training     diary.      Previbration and postvibration (just after, 10.minute and 30.minute) levels of plasma     sclerostin will be measured on first, second and fifth day of experiment. Sclerostin levels     will be measured by human sclerostin ELISA kit.   "
150794|NCT01310322|"     A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423     when administered in different ways.   "
150795|NCT01310309|"     The purpose of this two part study is the assessment of the performance of the XIENCE V®     Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific     setting of patients with Multi-Vessel Coronary Artery Disease (MVD).   "
150796|NCT01310296|"     The purpose of this study is to determine the mass balance and absolute bioavailability of a     single oral dose of 14C-labeled lofexidine compared to a single intravenous dose of     lofexidine.   "
150797|NCT01310283|"     The goal of this study is to address the effectiveness of a modified cavity prevention     protocol for 5-9 year-old children which emphasizes better diet modification, more frequent     professional fluoride applications, and xylitol product usage based on individual risk status     in a 1-year randomized controlled clinical trial in the University of California, San     Francisco (UCSF) Tenderloin Community Pediatric Dental Clinic. The investigators hypothesize     that the regimen will help to reduce new cavities in children who are at risk for dental     cavities.   "
150798|NCT01310270|"     The hypothesis being tested is that in patients with stable claudication and documented PAD,     omega-3 supplementation for 1 month will lead to improvement in endothelial function as     measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the     vascular inflammatory profile as measured by a panel of established circulating inflammatory     biomarkers.   "
150799|NCT01310257|"     The aim is to improve understanding of the assessment of pain experience in patients with     osteoarthritis (OA) of the knee. The current study will be divided into two parts. In Study     1, the investigators will analyse existing questionnaires relevant to the mechanisms and     therapeutic targets of knee OA to establish discrete dimensions that discriminate between the     different mechanisms of pain. On the basis of this analysis, the investigators will refine     the questionnaires to maximise their sensitivity to knee OA. In Study 2, the investigators     will seek to confirm the factor structure identified in the questionnaires in Study 1 and     explore potential mediator and moderator variables between pain and quality of life using the     refined measures. The investigators will also evaluate Quantitative Sensory Testing as a     predictor of OA knee pain.   "
150800|NCT01310244|"     To define Phase 1/2 Maximum Tolerated Dose Study of Belinostat (PXD-101) in Combination with     Paclitaxel plus Carboplatin in Chemotherapy-Naive Patients with Stage IV Non-Small-Cell Lung     Cancer (NSCLC).   "
150801|NCT01310231|"     The purpose of this study is to determine if the addition of metformin to standard     chemotherapy improves progression free survival in women with metastatic breast cancer.   "
150802|NCT01310218|"     The purpose of the study is to prospectively compare the functional, satisfaction, and wound     outcomes of patients treated with one of two accepted methods of postoperative dressing     following carpal tunnel release. Hypothesis: There will be no difference between the short     term (approximately 2 - 3 days)and longer term (9 to 14 days)bulky dressing groups in terms     of outcomes.   "
150803|NCT01310205|"     This is an extension of ongoing study SCI-SCV-HCV-P2-001 in which subjects will be invited to     participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001     and are eligible for retreatment with peg-IFN and RBV.   "
150804|NCT01310192|"     The purpose of this project is to develop and evaluate fluorine-18 (F-18) fluorocholine (FCH)     positron emission tomography (PET) as an imaging technique that can be used to delineate     malignant tumors in the prostate gland. The proposed technique works by measuring the tissue     metabolism of FCH, a substrate that is preferentially metabolized by cancer cells due to     malignant over-expression of the choline transporter and choline kinase enzyme. The project     scope covers a clinical study to recruit men with prostate cancer who have elected treatment     by radical prostatectomy surgery. These men will undergo pre-operative PET scanning to     measure F-18 FCH uptake in anatomical sextants of the prostate gland. Imaging results will be     compared to histopathologic analyses of the prostatectomy specimen to determine the accuracy     of F-18 FCH PET for detecting cancerous prostate sextants.   "
150862|NCT01309256|"     Minimally invasive surgery revolutionized the field of gastric cancer surgery. The surgical     robot was introduced to alleviate the difficulty of laparoscopic surgery. Although many     studies have reported successful outcomes for robotic surgery, there is no multicenter     prospective analysis regarding the advantage of the robotic gastrectomy. The aim of this     study is to analyze the surgical outcomes of the robotic gastrectomy focusing on the learning     curve, cost-effectiveness, quality of life, and acute-inflammatory reaction in comparison     with laparoscopic gastrectomy.   "
150805|NCT01310179|"     This study will test whether it is possible to introduce new genetic material into a small     portion of a tumor and have the product of the new gene not only kill those tumor cells that     were infected initially, but also the surrounding tumor cells as well with limited or no harm     to the patient. The desired effects of this approach are achieved by focusing potent     chemotherapies directly within the tumor itself and, as a result, avoiding injury to the     remainder of the body. In this study, we will use two components, the first of which is a     virus, known as an adenovirus, that has been crippled (i.e., it cannot make more of itself)     and loaded with a bacterial gene called E. coli purine nucleoside phosphorylase (PNP).     Adenoviruses are considered to be relatively safe vehicles for gene delivery and are     presently being used in numerous human trials and therapies worldwide, including a head and     neck cancer therapy approved for use outside the United States. The loaded adenovirus will be     used to deliver the PNP gene directly into a tumor in patients. This gene is not expected to     have an effect itself. However, the gene produces PNP inside the tumor and this protein will     activate the second component of the therapy, a drug called fludarabine phosphate, which is     approved by the FDA for certain types of blood-cell cancers, but has not been shown to be     effective against most solid tumors. The proposed therapy gives the patient several infusions     of fludarabine following the injection of the virus carrying the PNP gene and, as the     fludarabine enters the tumor, it will be converted by PNP into a second compound,     fluoroadenine. Numerous studies in mice and rats have shown that fluoroadenine is a very     potent anti-cancer agent and that it will kill the tumor cells where it is made as well as     those in the immediately surrounding area.   "
150806|NCT01310166|"     The purpose of this study is to investigate which changes in immunological biomarkers under     treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be     detected.   "
150807|NCT01310153|"     Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective     Caesarean birth. There has been no study comparing the efficacy of immediately positioning a     newly born infant prone vs. supine for the first 30 60 seconds of life after delivery by     Caesarean birth.      The investigators hypothesize that when the infant is prone they will have postural drainage,     better dorsal lung expansion, less vagal response from suctioning and less agitation     secondary to the righting reflex.      The investigators will compare 1033 term babies divided by randomization into two groups     prone and supine. The investigators will check for incidence and severity of Respiratory     Distress, Use of FiO2 or respiratory support, admissions to NICU.   "
150808|NCT01310140|"     Studies have shown that people with certain disorders have an increased risk of developing a     condition called Metabolic Syndrome (MS). In this study, the investigators want to learn more     about MS among people staying in the hospital for treatment of Major Depressive Disorder     (MDD) and also Major Depressive Disorder with Psychotic Features (MDpsy). The investigators     also want to learn more about a stress hormone called cortisol that is made in the body.     Those who take part in this study will answer some questionnaires, be given some psychiatric     interviews, and have some blood taken along with a urine sample.      The investigators believe that patients in the hospital with MDpsy will have higher baseline     rates of MS factors, cortisol levels, dexamethasone non-suppression, and insulin resistance,     compared with MDD alone.   "
150809|NCT01310127|"     This is a single-center, randomized, investigator-masked, parallel group, and     active-comparator controlled study investigating the clinical outcomes for visual acuity and     macular thickness after treatment with Bromday (bromfenac ophthalmic solution) 0.09% QD or     Nevanac (nepafenac ophthalmic suspension) 0.1% TID in subjects who have undergone cataract     extraction with posterior chamber intraocular lens implantation.   "
150810|NCT01310114|"     The primary objective of the study is to assess the safety and tolerability of Human     Placenta-Derived Cells (PDA001) at 3 different dose levels versus placebo (vehicle control)     administered intravenously in subjects following ischemic stroke. The secondary objective of     the study is to assess the effect of PDA001 on improvement in clinical function following     ischemic stroke.   "
150811|NCT01310101|"     The rationale of the study is to explore the safety and efficacy of ofatumumab in combination     with dexamethasone (O-dex regimen) in patients with refractory/relapsed CLL. Moreover, the     hypothesis is that this approach will be able to achieve at least the same response rates     compared with R-dex regimens (historical controls; manuscript submitted to Leukemia), while     maintaining lower toxicity profile.   "
150812|NCT01310088|"     The global epidemic of obesity in childhood continues to evolve and threaten future health     and life expectancy primarily due to the increased incidence of cardiovascular disease.     Obesity is strongly related to high blood pressure (hypertension) and both conditions pose a     risk for target organ damage, which can follow a subject from childhood into adult life. The     AORTA study will investigate central hemodynamics and organ damage in 100 obese children and     adolescents in order to gain insight to the complex interplay of hypertension, obesity and     subclinical damage in order to intensify more precise prevention, thereby reducing the future     development of cardiovascular disease.   "
150813|NCT01310075|"     The goal of this clinical research study is to learn if the complication rate and     post-surgical appearance differ based on what type of mesh is used for breast reconstruction     surgery.   "
150814|NCT01310062|"     More recent studies have shown that the HBV-infected population has a greater risk of     development of hepatocellular carcinoma. Nevertheless, there are still a significant number     of people chronically infected by HBV who do not develop the complication. Hence, there exist     biological markers that could be indicator for the disease-inducing and carcinogenic     potential of the virus.   "
150815|NCT01309893|"     The objective of this study is to determine the clinical feasibility and to evaluate the     product performance of investigational contact lenses.   "
150816|NCT01309880|"     The objective of this study is to determine the clinical feasibility and to evaluate the     product performance of investigational contact lenses developed by Bausch + Lomb.   "
150817|NCT01309854|"     The purpose of this study is to investigate the drug interaction between fostamatinib and     pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone     when administered alone and with fostamatinib in healthy subjects.   "
150818|NCT01309841|"     The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of     opioid-induced constipation in patients with non-cancer-related pain, including those     patients that have inadequate response to laxative therapy (LIR).   "
150821|NCT01309802|"     Treating patients with Raynaud's phenomenon who have chronic pain and ulcerations is     extremely challenging. Published reports and our previous work support our hypothesis that     symptomatic patients experience relief of pain and healing of ulcerations with minimal     adverse effects when treated with botulinum toxin type A (Btx-A) injections for Raynaud's     phenomenon. The proposed study is the first clinical trial and prospective study designed to     document whether or not 1) Btx-A injection relieves pain in a patient's hand affected with     Raynaud's disease better than a placebo within 28 days of injection, and 2) Btx-A injection     relieves pain associated with Raynaud's disease for longer than 28 days, improving patients'     quality of life. Through this study we intend to further determine the effect of injected     Btx-A on relieving chronic pain and ulcerations to the ischemic hand while characterizing the     patients for whom this treatment is most effective.   "
150822|NCT01309789|"     The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially     and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive     mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is     a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK,     immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination     with multi-agent front-line chemotherapy.   "
150823|NCT01309776|"     The primary object of this study is to confirm the superiority of tianeptine compared to     escitalopram on effects that improves subjective and objective cognitive impairments in     patients suffering from major depressive disorder.   "
150824|NCT01309763|"     This is a randomized, controlled, parallel group, patient-blinded, single-center, phase I     pilot study to assess tolerability and safety of repeated subcutaneous administration of a     single-dose of AFFITOPE AD03 applied with or without adjuvant to patients with mild to     moderate Alzheimer's disease.   "
150825|NCT01309750|"     Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in     patients after recent antibiotic use. The current standard of care treatment for severe C.     diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is     unsuccessful, it can lead to need for removal of the entire colon or even death. In fact,     mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted     mortality rate is 14% for severe infection. It is believed that the failure of treatment may     stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral     vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin     functions by direct contact with the colon. It is presumed that this paralysis of the small     intestine is present but has never been proven. The objective of the study is to prove that     there is an adynamic ileus present in c. diff colitis and therefore lead to investigations     into improved treatment.   "
150826|NCT01309737|"     The main objective of this study is to compare the effects of CP-690,550 with the effects of     placebo in patients being treated for moderate to severe chronic plaque psoriasis. This     one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.   "
150827|NCT01309724|"     Inadequate identification of and subsequent delayed therapy for patients with hypoperfusion     (including hypovolemia, congestive heart failure and sepsis) is a common problem faced by     physicians and intensivists caring for critically ill patients. Bedside clinical assessment     is notoriously inaccurate in diagnosing complex etiologies of hemodynamic disturbances and in     deciding on the appropriate therapy. Invasive techniques which are often required to guide     diagnosis and therapy have significant risks associated with them, are costly, and are time     consuming. New technology has been developed that allows for instantaneous, noninvasive     monitoring of key hemodynamic parameters, like stroke volume, peak velocity and cardiac     output. This new technology has the potential to improve recognition of the etiology of     hemodynamic disturbances and assist the clinician in optimizing therapy based on changes in     hemodynamic parameters. There is significant potential for this to be translated into     improved outcomes in critically ill patients, but this has never been studied.   "
150828|NCT01309711|"     N-acetylaspartate (NAA) is a surrogate neuronal marker and its proton magnetic resonance     spectroscopy (1H MRS) signal decreases with increasing neuronal mortality associated with     cerebral hypoxia-ischaemia. The MRS lactate (Lac)/NAA peak-area ratio increases during and     after severe cerebral hypoxia-ischaemia reflecting mitochondrial injury and impaired     oxidative phosphorylation.      Aims: (1) To establish normative ranges for thalamic 1H MRS NAA concentration and Lac/NAA in     healthy newborn infants (2) To examine the accuracies of thalamic 1H MRS NAA concentration     and Lac/NAA for predicting adverse neurodevelopmental outcome in neonatal encephalopathy (NE)      Design: Prospective observational study Methods: Year 1: Following 1H MRS methodology     optimisation 40 healthy control infants will be recruited to collect normative data. Year 2     to 3: 115 infants with NE, undergoing therapeutic hypothermia will be recruited. MRS will be     performed aged less than 4 days and 7 to 14 days and thalamic NAA levels and Lac/NAA will be     quantified; Qualitative interviews to evaluate parental understanding of this biomarker. Year     4, 5: Outcome assessment by BSID III at 18 months.      Outcomes: Mean thalamic NAA levels and Lac/NAA and appropriate confidence intervals in normal     infants, and thalamic NAA levels and Lac/NAA in infants with NE according to     neurodevelopmental outcome. Areas under curves for thalamic NAA and Lac/NAA will be examined     separately for early & late MRS. Accuracy of early MRS will inform utility of this     investigation in decisions about withdrawal of life support; late MRS will inform about     efficacy as a surrogate end point in clinical trials. Qualitative interviews will be     thematically analysed and reported.   "
150829|NCT01309698|"     This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics     of vildagliptin in Japanese patients with type 2 diabetes.   "
150860|NCT01309282|"     This observational study will assess the long-term efficacy and safety of MabThera/Rituxan in     routine clinical practice in patients with sero-positive rheumatoid arthritis who are     non-responders or intolerant to a single tumour necrosis factor (TNF) inhibitor. Data will be     collected from each patient over 2 years.   "
150861|NCT01309269|"     This observational study will assess the effect of long-term treatment with Mircera (methoxy     polyethylene glycol-epoetin beta) in chronic kidney disease patients with renal anemia. Data     will be collected from each patient for at least 24 months.   "
152017|NCT01293968|"     The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and     Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)   "
150830|NCT01309685|"     Background:      - Varenicline (Chantix ) is a drug that is approved by the Food and Drug Administration (FDA)     to help people stop smoking. Varenicline is very effective in helping some people quit     smoking, but is less effective for others. Researchers are interested in conducting more     in-depth studies into how varenicline works, including its effect on smokers' responses to     items that may trigger cigarette cravings, in order to develop better smoking cessation     medications.      Objectives:      - To examine the effectiveness of varenicline as an effective medication for tobacco     addiction by studying its effect on nicotine reinforcement, nicotine-seeking behavior,     cue-elicited craving, and performance impairment and craving after overnight tobacco     deprivation.      Eligibility:      - Individuals between 18 and 50 years of age who have been smoking at least 10 cigarettes per     day for at least 2 years.      Design:        -  This study will require 12 study visits. Some visits will be brief and other visits that          involve test sessions will last up to 8 hours. If no sessions are repeated, the study          will take 26 days. Participants will not be required to attempt to quit smoking during          this study.        -  Participants will be screened with a full physical examination and medical history,          blood and urine tests, and other tests as required by the study researchers.        -  Participants will take two sets of pills during the study: the first set during the          first 12 days of the study, followed by a 2-day break, then the second set during the          last 12 days. Some of the pills will contain varenicline, and others will be placebos.        -  On Day 1 of the study, participants will come to the National Institute on Drug Abuse to          receive the first set of pills. Participants will take the first pill before leaving.        -  On Day 8, participants will have a training session that will measure the amount of          carbon monoxide in the breath. Participants will also complete several questionnaires          about smoking habits and current mood, and will have a chance to practice the procedures          they will do in the study.        -  On Days 9 and 10, participants will have behavioral test sessions that will last 7 to 8          hours. Day 9 will involve tests of cue response to items that may trigger cigarette          cravings, and tests of general nicotine cravings over several hours. Day 10 will involve          tests of general nicotine cravings over several hours, and then tests of          nicotine-seeking behavior. Participants will be provided with lunch during these all-day          sessions.        -  On Day 11, participants will have memory and attention tests, and will provide a blood          sample. Participants will not be allowed to smoke for 12 hours before the start of the          next test on Day 12.        -  On Day 12, participants will provide a breath sample, and will have two sets of memory          and attention tests before they will be permitted to start smoking again. There will be          no tests on Days 13 and 14.        -  Starting on Day 15, participants will repeat the schedule of tests from Days 1 through          12 with the second set of pills.   "
150831|NCT01309672|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such     as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth.      PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate     works in treating patients with prostate cancer who have undergone initial hormone therapy.   "
150832|NCT01309659|"     The purpose of this study is to determine whether treatment of unexplained anemia in older     adults with a short course of weekly intravenous iron infusions can improve physical activity     and therefore quality of life.   "
150833|NCT01309646|"     This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine     when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6     months of age.   "
150834|NCT01309633|"     Aims:      Primary objectives        -  To determine the pathological complete response (CR)* rate of intermittent sunitinib          administered with combination cisplatin and gemcitabine as systemic therapy for locally          advanced or systemic NPC.        -  To determine the safety and tolerability of intermittent sunitinib administered with          combination cisplatin and gemcitabine as systemic therapy for locally advanced or          systemic NPC.      Secondary objectives        -  To determine the clinical response rate (RR; complete and partial response)+ of          intermittent sunitinib administered with combination cisplatin and gemcitabine as          systemic therapy for locally advanced or systemic NPC.        -  To evaluate the pharmacodynamic effects (imaging, circulating and tissue) of          intermittent sunitinib administered with combination cisplatin and gemcitabine as          systemic therapy for locally advanced or systemic NPC.        -  To compare the early pharmacodynamic effects (imaging, circulating and tissue) of a          loading dose of 12.5mg or 25mg sunitinib for 7 prior to administration of systemic          cisplatin and gemcitabine chemotherapy.   "
150835|NCT01309620|"     Zinc supplementation reduces the extent of oxidative damage and improves vascular indices in     type 2 diabetics   "
150836|NCT01309607|"     The purpose of this study is to evaluate the efficacy and safety of weekly paclitaxel and     carboplatin, in combination with lapatinib, in the neoadjuvant treatment of non-metastatic     erbB2-positive breast cancer.      Secondary objectives include:        -  To determine the safety and tolerability of weekly paclitaxel and carboplatin, combined          with lapatinib, in an Asian population        -  To determine breast conservation rates following neoadjuvant paclitaxel/ carboplatin/          lapatinib        -  To determine clinical response rates and relapse-free survival of patients treated with          neoadjuvant paclitaxel/ carboplatin/ lapatinib        -  To identify predictive tumour biomarkers for pathologic complete response      The investigators hypothesize that pathologic complete response rates will be improved from     15% to 35% with the neoadjuvant regimen of carboplatin/ paclitaxel/ lapatinib compared to     standard chemotherapy alone in HER2 positive early stage breast cancers.   "
150837|NCT01309594|"     An international investigation to evaluate if, and if so how long, autologous bone marrow     hematopoietic stem cell transplantation can safely restore liver functions for HIV infected     patients who have decompensated liver cirrhosis.   "
150838|NCT01309581|"     The primary objectives of this study are to investigate the potential for ketamine anesthesia     to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to decrease     acute ECT-induced adverse cognitive effects.   "
150839|NCT01309568|"     The objective of this study is to demonstrate the clinical performance of the Quidel Reader     Influenza A+B test and Quidel Reader with the following sample types: nasal swab,     nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on     comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or     Alternative Laboratory.   "
150840|NCT01309555|"     This is an Australian, Multicentre, Observational Registry to study Adherence and Long Term     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.   "
150841|NCT01309542|"     The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR)     during open-label treatment in adult outpatients who had a primary diagnosis of major     depressive disorder (MDD). The study also evaluated the long-term response of subjects     receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and     absence of depressive symptoms (remission).   "
150842|NCT01309529|"     Current standard of practice in study institution dictates day of surgery urinary catheter     removal in general thoracic surgery patients receiving thoracic epidural analgesia. The     investigators hypothesize that this practice results in low recatheterization rates secondary     to urinary retention and low urinary tract infection rates.   "
151657|NCT01298726|"     The purpose of this study is to examine the effect of a pharmaceutical care program on the     level of glycated hemoglobin for hyperglycemic users of brazilian public health care system     in drug treatment for type 2 diabetes.   "
150843|NCT01309516|"     The study aims to:        1. Develop a culturally appropriate psychosocial intervention        2. Test feasibility and acceptability of psychosocial intervention in women suffering from          postnatal depression.      Primary Hypothesis:      Depressed mothers who will receive the group intervention will show significant improvements     in terms of symptoms of depression.      Design:      Randomised controlled trial.      Setting:      Outpatient department of Civil hospital Karachi.      Participants:      A total of 84 depressed mothers will be randomised equally to an intervention group and a     Treatment as usual control group.      Interventions:      The 12 session multimodal psychosocial intervention will be delivered to mothers in the     intervention group over a three months period. Each session would take up to 45 minutes.     Control group will receive standard postnatal follow-up.      Outcome measures:      Primary outcome measures would be mothers' scores on Edinburgh Postnatal Depression Scale     (EPDS)and Hamilton Depression Rating Scale (HDRS).   "
150844|NCT01309503|"     The main purpose of the study is to estimate speech intelligibility in noise. A Norwegian     Hearing in Noise Test (HINT) for children will be implemented, and test results for normal     hearing (NH) children and adults will be collected. Test results for groups of hearing aid     (HA) users and test results for cochlea implant (CI) users will be collected and compared to     the NH group and between groups of HA users and CI users. A group of single sided hearing     loss patients will also be included. Binaural benefits of two ears, two HAs and two CIs will     be estimated.   "
150845|NCT01309490|"     The purpose of this study is to learn whether oral Ribavirin is safe and effective in     treating patients with solid tumour cancers, that have high levels of the protein eIF4E.   "
150846|NCT01309477|"     It is a pilot study to explore the efficacy and safety of Tacrolimus Sustained-release     Capsules (ADVAGRAF) on 6-month induction therapy of Refractory Nephrotic Syndrome (RNS).   "
150847|NCT01309451|"     The investigators hypothesize that a combination treatment with Avastin and Ozurdex will     result in a more rapid improvement of visual acuity compared to the use of Avastin alone.   "
150848|NCT01309438|"     The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of     rivaroxaban when administered with erythromycin to study participants with mild or moderate     renal impairment compared to the pharmacokinetics and pharmacodynamics of rivaroxaban     administered to study participants with normal renal function.   "
150849|NCT01309425|"     The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of     tapentadol (CG5503) in healthy Japanese and Korean adult male participants.   "
150850|NCT01309412|"     The purpose of this study is to assess the safety and the tolerability of siltuximab up to     11.0 mg/kg in combination with bortezomib and dexamethasone for patients with relapsed or     refractory multiple myeloma.   "
150851|NCT01309399|"     Teriparatide is a potent osteoporosis medication that helps prevent fractures, however, the     investigators know little about its effect on the hip. The investigators will evaluate hip     bone samples from patients treated with teriparatide before undergoing hip replacement. The     information will help us understand how teriparatide might help reduce hip fracture risk.   "
150852|NCT01309386|"     The purpose of this study is to evaluate the conversion rate based on the number of     participants achieving pain control and safety within 1 week after switching the opioid     (morphine-like medications) analgesics (drug used to control pain), when tapentadol     extended-release (ER) (JNS024ER) is orally administered to participants treated with     around-the-clock opioid analgesics, for their moderate to severe (very serious, life     threatening) chronic (lasting a long time) malignant (cancerous) tumor-related (a mass in a     specific area) cancer (abnormal tissue that grows and spreads in the body) pain.   "
150853|NCT01309373|"     The purpose of this study is to estimate the level of symptomatic and psychosocial remission     of patients with schizophrenia and schizoaffective disorder in standard clinical practice as     a function of the degree of adherence to antipsychotic treatment. The secondary objectives     are to study the level of community integration of the patients included in the study, and     its influencing factors, to analyze the role of various sociodemographic factors, factors     related to the course of disease and the psychopathological status of the patient in     community integration and remission, to analyze the potential predictors of a favorable     course (symptomatic and psychosocial remission) and a poor course (no symptomatic or     psychosocial remission), to assess the impact of treatment adherence on the change in the     functional and community integration status of patients (based on the occupation,     independence level, and degree of disability variables), to assess the significance of     premorbid (academic and social) adjustment in the symptomatic and functional remission and     the community integration status of patients and to correlate the level of insight to the     remission and integration status of patients.   "
150854|NCT01309360|"     Clinical aim: Does reducing the dose of local anesthetic in ultrasound-guided axillary plexus     anesthesia have any effect on the success rate and additional parameters of block quality?     Methodology: In this prospective cohort study three groups of 40 outpatients each were     administered dosages of 1% prilocaine of either 40mL, 30mL or 20mL for axillary plexus     anesthesia. Met-Hb was measured prior to administration of the block and then hourly until     the Met-Hb concentration fell. Parameters of block quality and any adverse effects were     recorded. The level of significance was defined with α ≤ 0.05.   "
150855|NCT01309347|"     The purpose of this study is obtain prosthetist's feedback on the novel conformable socket     material developed by Infoscitex, and determine if it is a viable alternative to current     prosthetic socket liners. During this task, the research team will travel to the prosthetists     locations to have them evaluate the socket system by examining the material and providing     their professional opinions and feedback with regard to comfort and fit for the amputee, its     ease of use, and breathability.   "
150856|NCT01309334|"     Multicenter open-label prospective comparative study of PET-scan and MRI at the time of     diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy.   "
150857|NCT01309321|"     The purpose of this study is to determine if an intensive handwashing intervention     administered to primiparous women during their pregnancy can increase maternal handwashing     with soap at critical times.   "
150858|NCT01309308|"     Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to     delivery.   "
192534|NCT00367328|"     A research study to determine the efficacy of a 1320 nm laser device for the treatment of     hidradenitis suppurativa.   "
150863|NCT01309243|"     The purpose of the study was to evaluate the safety and efficacy of the emtricitabine     (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR)     compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously     received treatment with antiretroviral medications.      Participants were randomized in a 1:1 ratio to receive one of the study treatments.     Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL)     at screening. A treatment duration of 96 weeks was planned, with the option for subjects in     FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is     commercially available or until Gilead Sciences elects to terminate development in that     country.   "
150864|NCT01309230|"     This is a Phase II open-label trial of maintenance Vigil™ autologous tumor cell vaccine.     Tumor will be harvested at the time of surgical debulking (standard of medical care).     Subsequently, patients achieving clinical CR following primary surgical debulking and doublet     chemotherapy will be stratified for i) surgical stage (Stage IV or suboptimal debulking (>1     cm residual) Stage III disease versus Stage III patients with optimal debulking (<1 cm     residual)) and ii) post-op chemotherapy, pre-vaccine CA-125 >10 ≤ 20 U/mL versus 0≤10 U/ml.     (Note: patients with Stage IIIc ovarian cancer will be additionally evaluated as a subset     using descriptive statistics only). Patients will receive 1.0 x 10^7 cells / intradermal     injection of gene transfected autologous tumor cells, Vigil™ once a month for up to 12 doses     as long as sufficient material is available. Enough harvested tissue to provide a minimum of     4 monthly injections will be required for entry into the study. Hematologic function, liver     enzymes, renal function and electrolytes will be monitored monthly. Immune function analysis     including ELISPOT analysis of cytotoxic T cell function to autologous tumor antigens will be     monitored at (≤24 hours before) tissue harvest, ≤24 hours before the first cycle of     chemotherapy (post debulking), ≤24 hours before the third cycle of chemotherapy (post     debulking), baseline (screening), prior to Vigil™ injection Months 2, 4, 6 and at EOT. The     dates of the last dose of chemotherapy and the administration of Vigil™ vaccine #1 will be     recorded. Treatment will be continued until disease recurrence or exhaustion of the patient's     vaccine supply. If ≥ Grade 2 toxicity by NCI Common Toxicity Criteria (excluding Grade 2     fever ≤ 24 hours and Grade 2 and 3 injection site reactions) develops related to study     treatment the vaccine dose will be reduced by 50% and continued on a monthly basis. If a     single patient develops ≥ Grade 3 toxicity (other than injection site reaction) related to     study treatment the trial will be placed on hold for reevaluation of design in discussion     with FDA. During this hold, no new subjects will initiate dosing, but subjects already being     dosed may continue dosing as scheduled if deemed clinically appropriate by the PI.   "
150865|NCT01309217|"     Nurse-administered smoking cessation interventions have been shown to be efficacious, but are     seldom implemented due to lack of training and time. This project aims to disseminate and     test the nurse-administered Tobacco Tactics intervention in 6 hospitals.   "
150866|NCT01309204|"     The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine     fixed combination in lowering intraocular pressure (IOP) relative to each of its individual     active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with     open-angle glaucoma or ocular hypertension.   "
150867|NCT01309191|"     The purpose of this study is to determine whether Minoxidil treatment affects hair growth in     patients with male pattern baldness or androgenetic alopecia.   "
150868|NCT01309178|"     Cystic fibrosis patients suffer from a chronic destruction of the lung, frequent and finally     chronic pneumonia and a reduced life expectancy. Unfortunately, no curative treatment for     cystic fibrosis is available, neither are treatments established that prevent the disease.     Our data identify ceramide as a potential novel target to treat cystic fibrosis.      Two smaller trials support the notion that inhibition of the acid sphingomyelinase by     amitriptyline improves the lung function of CF-patients even at a dose that is low enough to     avoid adverse effects.      In the present proposal the investigators, therefore, aim to test in a larger cystic fibrosis     patient population whether an inhibition of ceramide release in the lung caused by the lack     of functional CFTR improves the lung function of cystic fibrosis patients. Inhibition of     ceramide-release in the lung will be achieved by treatment with amitriptyline, which is used     as an anti-depressant drug for almost 50 years. Although it is not absolutely specific, it     seems to be relatively specific for the degradation of acid sphingomyelinase (typically     60-80% of cellular acid sphingomyelinase are degraded), which releases ceramide from     sphingomyelin.      If the data confirm the beneficial effect of amitriptyline already observed in our     preliminary studies, the present clinical study may establish a novel treatment to improve     clinical symptoms of cystic fibrosis and, moreover, to prevent or at least delay the onset of     cystic fibrosis.      Hypothesis        -  Amitriptyline reduces ceramide concentrations in respiratory epithelial cells (measured          in nasal epithelial cells obtained by brushing nasal mucosa).        -  Amitriptyline treatment reduces cell death in bronchi and deposition of DNA on the          respiratory epithelium, which permits elimination of P. aeruginosa from the lung          (measured as P. aeruginosa counts in tracheal fluid).        -  Amitriptyline treatment results in normalization of the function of leukocytes (number          determined in serum and tracheal fluid)        -  Amitriptyline reduces systemic and local inflammation (measured as cytokines in plasma          and tracheal fluid).      Based on these effects amitriptyline increases the lung function of cystic fibrosis patients     (measured by FEV1).   "
150869|NCT01309165|"     Novel stroke rehabilitation approaches, such as task-specific training (TST), have shown     promise in improving stroke recovery components such as basic mobility and activities of     daily living; however, evidence suggests these improvements are not generalized and     transferred to home, community, or work settings, and usually do not impact overall     participation outcomes. Further, these treatments are very intense, with total treatment     times as high as 30 to 60 hours, making them clinically or economically unfeasible in many     settings. In contrast, approaches incorporating cognitive strategy training have shown great     promise to not only improve functional activity performance in people living with stroke, but     also to facilitate generalization and transfer beyond the clinical setting, and to do so in     10 to 15 treatment hours. Cognitive Orientation to daily Occupational Performance (CO-OP) is     an established treatment approach that uses cognitive strategies in combination with TST.     Evidence from other research groups and findings from our own participant interview data     indicate that the approach may be even more effective if introduced much earlier in the     rehabilitation process, however, CO-OP has not yet been tested in this sub-acute population.     Therefore, the specific project goals are: 1. To refine the CO-OP treatment approach for use     with people less than three months post stroke; 2. To evaluate, in a Phase II clinical trial,     the preliminary efficacy of the refined protocol compared to standard occupational therapy on     immediate and longer-term skill performance and participation; 3. To determine effect sizes     for power calculations for a future Phase III clinical trial to test the new protocol versus     contemporary treatment. The research approach consists of Part 1, Protocol Refinement, and     Part 2, Exploratory Phase II Clinical Trial.   "
150870|NCT01309152|"     The investigators hypothesize that cefazolin perfusion to subcutaneous adipose tissue is     reduced in morbidly obese patients. The primary objective of this exploratory pilot study is     therefore to investigate target site (subcutaneous adipose tissue) penetration of cefazolin     in morbidly obese patients and non-obese patients. The investigators aim to examine whether     and how cefazolin plasma concentrations are predictive of subcutaneous (target) cefazolin     concentrations. Possible factors of influence on the distribution of cefazolin (tissue     perfusion, body weight, distribution of adipose tissue, other) will be identified.   "
150901|NCT01308658|"     In this study participants will be given 800 mg darunavir, either as one 800-mg tablet     formulation (G002), or as two commercially available 400-mg tablets formulation (F030), to     evaluate the effect between both, in the presence of low-dose ritonavir under fasted and fed     conditions.   "
150962|NCT01307852|"     The goal of this clinical research study is to learn if a rectal balloon with attached     radiation detectors can be used to help researchers monitor the dose of external beam     radiation that is delivered to the prostate during treatment. This may help researchers     better understand the side effects of radiation therapy, such as rectal bleeding, and may     lead to changes in treatment planning or treatment delivery.   "
152206|NCT01291511|"     The purpose of this study is to determine whether Iloperidone is effective in the prevention     of relapse in patients with schizophrenia   "
150871|NCT01309139|"     The primary objective is to compare the systemic exposure to tiotropium and CD 1857 after     treatment with the fixed dose combination (fixed dose combination (FDC), Treatment A) of     tiotropium plus BI 54903 (ethanolic solution for inhalation (EIS), Respimat (RMT) B) with the     systemic exposure following inhalation of the free combination (Treatment B) of tiotropium     (aqueous solution for inhalation (AIS), RMT A) plus BI 54903 (EIS, RMT B), when administered     once-daily over 21 days via Respimat(R) (RMT).      The secondary objectives are:      to compare the systemic exposure to tiotropium and CD 1857 after single dose administration     of FDC and of the free combination of tiotropium/BI 54903 to compare the systemic exposure to     BI 54903 after a single dose and at steady state after multiple doses of the FDC and of the     free combination of tiotropium/BI 54903 to compare the safety and tolerability of tiotropium     and BI 54903 when administered as FDC and as free dose combination, respectively   "
150872|NCT01309126|"     Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified     subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to     treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed     until progression or discontinuation for some other reason. Efficacy will be assessed via     Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans     will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and     biomarker parameters will also be assessed.   "
150873|NCT01309113|"     Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180     patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to     achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150 are     expected to complete the study per protocol.      Study objectives:      Identification of the optimal dosage of VAC BNO 1095 (product name) film coated tablets for     treatment of cyclic mastodynia and premenstrual syndrome.      To prove the efficacy of VAC BNO 1095 film coated tablets in the treatment of cyclic     mastodynia.      Dose regimen:      Group 1: VAC BNO 1095 1x10 mg:      1 tablet of verum in the morning, 1 placebo tablet in the evening      Group 2: VAC BNO 1095 2x10 mg:      1 tablet of verum in the morning, 1 tablet of verum in the evening      Group 3: Placebo:      1 tablet placebo in the morning, 1 tablet placebo in the evening      The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first     screening further visits are scheduled after the end of each of the first and second run-in     cycle, and after the first, second and third treatment cycle, respectively.      Visits will be performed during the menses at day 3 (-1+3 days), i.e. 2 days after day 1 of     menstruation number n, with exception of the first screening visit which can be performed at     any time prior to the first run-in cycle. Subsequently the time between the first study visit     and the onset of the first run-in cycle menses T shall be added to the overall study     duration.      In case that the next menstruation does not commence as expected, the patient should contact     her investigator immediately in order to schedule a new appointment, approximately on the     actual day 3 of the menses.   "
150874|NCT01309100|"     The objective of this study is to determine the clinical feasibility and to evaluate the     product performance of investigational contact lens.   "
150875|NCT01309087|"     The primary objective of this study is to substantiate prediction accuracy(with a tighter 95%     confidence interval compared to current diagnostic modalities), of a lung cancer biomarker     for risk stratification of patients into high and low risk categories to aid in clinical     evaluation of the patient.   "
150876|NCT01308983|"     Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of     young adults with prehypertension.   "
150877|NCT01308970|"     The purpose of this study is to determine if participation in one of three different health     management groups will elicit genomic and biochemical changes and decrease perceived stress     levels and symptoms in healthy, stressed adults. The investigators expect that changes in     self-reported psychological stress and symptoms will be directly linked to changes in     biological indicators (genomic expression profiles and neuroendocrine and pro-inflammatory     biomarkers).   "
150878|NCT01308957|"     The purpose of this study is to examine the effect of omega-3 fatty acid supplementation on     changes in muscle mass, muscular strength and physical function.   "
150879|NCT01308944|"     This research is looking at the effect of biobehavioral factors such as stress and whether     these factors alter how the body responds to chemotherapy, one of the purposes of this study     is to determine if the addition of a beta-blocker such as Propranolol (Inderal) is tolerable     when given with chemotherapy in the treatment of newly diagnosed ovarian, fallopian tube, or     primary peritoneal cancer. An additional purpose of the study is to understand if behavioral     factors such as depression and anxiety can alter different blood markers that affect tumor     vascularity. The Investigator wishes to determine whether the use of beta-blocker drugs such     as Inderal, might alter these behavioral factors by drawing blood prior to and after the     administration of Inderal as well as giving behavioral questionaires at different time     points. Beta-blockers are commonly used for the treatment of hypertension, protection of the     heart after a heart attack, and irregularities in heartbeats. Altering these factors might     boost the immune system and affect other areas of cancer biology, thereby allowing the     chemotherapy to be more effective. The significance of this research is that it may help     improve our treatments of this disease in the future.   "
150880|NCT01308931|"     Anti-mullerian hormone (AMH) has been shown to be a reliable marker of ovarian reserve. In     prior studies, tubal ligation has been shown to have an adverse effect on ovarian reserve.     One theory postulated for this effect is that the ovarian circulation is disrupted by the     procedure, leading to altered hormone production. In this prospective cohort study, the     investigators plan to analyze the rates of AMH decline by comparing the following     contraceptive methods: tubal ligation, Essure placement, and levonorgestrel intrauterine     devices (IUDs).   "
150902|NCT01308645|"     The purpose of this study is to determine efficacy of SB injection in Hepatocellular     Carcinoma (HCC).   "
150930|NCT01308268|"     The general purpose of the project is to analyse soil-transmitted helminthiases (STH) in a     highly endemic area in northern Argentina with a multidisciplinary approach. The specific     objectives are to evaluate the local epidemiology of STH, validate a new diagnostic serology     method for S. stercoralis and evaluate the efficacy and safety of a mass drug administration     regimen with albendazole and ivermectin.   "
150881|NCT01308918|"     Thoracic surgeries usually require lung isolation techniques. Double-lumen tube (DLT), either     right or left sided, is the most frequent tool used to realize this technique. In front of     difficult airways, the use of videolaryngoscopy (GllideScope®) (GS) may advantageous.     Hypothesis: We will test the hypothesis that under GS, the use of a specific semi-rigid     stylet is efficacious to insert a DLT, and also safe. The increased rigidity of the GlideRite     DLT Stylet for double-lumen tubes will enable the DLT to keep its form while it is railroaded     into superior airways. This new stylet combined to Glidescope® utilization will increase the     rate of successful intubation, especially in patients with difficult airways. This technique     will allow us to directly intubate with a DLT using the GlideScope®, avoiding a beforehand     SLT intubation and airway exchange catheter use. Consequently, its use could reduce risks     associated to blind insertion of DLT with airway exchange catheter (airway traumatism and     pulmonary aspiration). Primary objective: To determine the GlideRite DLT Stylet efficiency     for double-lumen tubes orotracheal intubation under videolaryngoscopy (GllideScope®).     Secondary objectives: to time successful intubation, to count the number of intubation     attempt, to verify the influence of difficult intubation score (DIS) on successful     intubation, and to log complications associated to its use. Exclusion criterion are: previous     history of difficult intubation, anticipated difficult mask ventilation, and anticipated     difficult intubation. Conclusion: The aim of using the GlideRite DLT Stylet for an     orotracheal intubation under videolaryngoscopy is to allow the primary intubation with a DLT     in patients with abnormal superior airways. These anomalies are more and more frequent.     Alternative airway management implies more manipulations, leading to an increased risk of     oxygen desaturation, lung aspiration, and airway lesions. Moreover, these alternatives take     more time than using a Glidescope, which can be compare to direct laryngoscopy. The     development of a semi-rigid stylet, such as the GlideRite DLT Stylet, is a great advancement     in the management of primary intubation with DLT, mainly in face of difficult airways.   "
150882|NCT01308905|"     The purpose of this study is to gain knowledge about how to best diagnose and treat tumors,     how tumors affect normal tissue and how treatment of tumors with radiation therapy and     chemotherapy affect tumors.   "
150883|NCT01308892|"     In the CHOC study the investigators will examine the effect of chocolate flavanols on     vascular function, inflammation, oxidative stress and markers of endothelial function. The     effects of both acute consumption and prolonged consumption will be studied. The secondary     objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve     the response to a high fat/high energy challenge.   "
150884|NCT01308879|"     The purpose of this clinical trial was to test the hypothesis that clients of clinicians who     were scheduled to receive weekly feedback on their clients' progress would improve faster     than clients of clinicians who were not scheduled to receive weekly feedback.   "
150885|NCT01308866|"     BACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging     lifestyles might change the trend. The aim of this study is to assess if hypercholesterolemic     patient involvement in the preventive decision with the help of a decision aid has an impact     on cardiovascular (CV) risk reduction superior to usual care.      METHOD: The design is a cluster randomised clinical trial. Participants are     hypercholesterolemic patients (>200 mg/dl or c-LDL>130) from four primary care teams of     Barcelona. Patients with previous CV events, age over 75 years or cognitive impairment are     excluded. It is expected to create two cohorts of 139 patients each one. The randomisation is     by doctor. Intervention group will receive information about their CV risk and the risk and     benefits of different preventive measures. They will have access to a decission aid that will     help them in the choice of the preventive measures.The material (printed and software) is     adapted to the Catalan Population using local CV risk tables and will meet the CREDIBLE and     DISCERN criteria. STUDY VARIABLES: Sociodemographic variables, CV risk factors, subjective     health (SF 12), decisional conflict, anxiety/depression, analytic controls, treatment,     treatment adherence, compliance and resources use. Basal evaluation and 3, 6, 12 month     assessment. The study, financed by FIS, will begin the 01-07-2007.      RESULTS: The expected results are a higher reduction on the CV risk factors in the     intervention group versus regular care.      CONCLUSIONS Study will provide a tool to be used in Spanish and Catalan population.   "
150886|NCT01308853|"     The study evaluates treatment procedure, efficacy and safety of NASHA BE for female breast     enhancement.   "
150887|NCT01308840|"     The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in     KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have     previously not received chemotherapy. This study will also examine the potential toxicities,     progression-free and overall survival in this population.   "
150888|NCT01308827|"     Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia and pneumococcal     meningitis among infants and children worldwide. Knowledge of the epidemiology of     pneumococcal disease is essential to assess the potential usefulness of pneumococcal disease     usefulness of pneumococcal conjugate immunization. There is a paucity of information     regarding pneumococcal disease burden in children in Latin America. Most studies are based on     passive microbiology laboratory surveillance that does not capture all invasive disease, thus     underestimating the true disease burden. Data from an active surveillance is available from     an specific region in Costa Rica, before introduction of universal vaccination with PCV-7. On     January 2009, PCV-7 was introduce into the universal vaccination program for all children     born after or on September 2008 using a 3+1 regimen therefore there is a possibility to     analyze the benefits of the introduction of this vaccine into the universal immunization     program. The only effectiveness data from Latin America have been published from Uruguay     where a significant decline in the incidence of pneumonias and meningitis was observed     following the introduction of PCV-7. This was associated with an increment of serotypes 19A,     1,5 and 7F. Uruguay modify PCV-7 to PCV-13. In Costa Rica on August 2011, PCV-7 was changed     for PCV 13. This study will provide information regarding the impact of PCV-7 and PCV-13.   "
150898|NCT01308697|"     Flail chest refers to a section of the rib cage that has broken away from the surrounding     ribs. Usually, more than one rib is involved, and they are broken in at least two places.     Flail chest typically is the result of blunt chest trauma. As a result of flail chest, the     chest wall becomes unstable and dangers of life threatening respiratory failure and hypoxemia     (lack of oxygen to circulating blood which will lead to organ damage or failure)occur.      Currently, these injuries are treated non operatively. However, small case series have     demonstrated that operative management can improve Intensive Care Unit (ICU) length of stay,     improved pulmonary function and decreased pain leading to decreased duration of mechanical     ventilation, and the incidence of complications related to this injury.      This study hopes to provide information on whether a prospective randomized trial is feasible     by first undertaking a small pilot study to determine rate of recruitment, data collection     methods, and integrity of study protocol.      Null Hypothesis 1: Enrollment of subjects with flail chest rib fractures into a prospective     multi-centre RCT is not feasible and a larger clinical trial is unlikely to be completed.   "
152343|NCT01289730|"     The study has the aim to investigate the efficacy and safety of etanercept in patients with     active undifferentiated spondyloarthritis (uSpA) over the period of 520 weeks.   "
150889|NCT01308814|"     Study Background and Objectives: In the U.S. the majority of heart disease deaths are in     women, not men. Much of the gender disparity in CVD rates relate to the burden of CV risk in     women after the menopause. Depression has been associated with an increased risk for CVD     morbidity and mortality. Even histories of recurrent depression in euthymic individuals are     associated with elevated CV risk. Understanding the depression-CVD link may have particular     relevance for women since women experience depression at a rate twice that of men.     Substantial convergent evidence indicates that ovarian failure (estrogen deprivation) is one     likely mechanism contributing to both CVD and depression in women. The perimenopause, a time     associated with a two-fold increase in rates of depression, may provide an ideal opportunity     for studying the pathophysiology of CV risk and depression in women.      The primary objective of this study is to examine the prophylactic role of estradiol in the     development of depressive symptoms and the progression of cardiovascular risk in     perimenopausal women with or without histories of depression. The investigators predict that     women susceptible to depression will be particularly vulnerable to the acceleration of CVD in     the context of the perimenopause and, consequently, will show differentially greater benefit     of estradiol treatment during the menopause transition for both indices of CV risk (e.g.     inflammation, endothelial function, stress reactivity), as well as depressive symptoms.   "
150890|NCT01308801|"     The purpose of this study is to determine the analgesic effectiveness of Repetitive     Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation     exercises in patient suffering from fibromyalgia.      A double blind clinical trial with two randomized parallel groups:        -  Placebo rTMS and rehabilitation exercise        -  Active rTMS and rehabilitation exercise   "
150891|NCT01308788|"     The purpose of this study will be to compare the aqueous production suppressant to aqueous     outflow drugs in terms of the response to known vascular parameters. Specifically; systemic     perfusion pressure, retrobulbar blood flow and retinal microcirculation.   "
150892|NCT01308775|"     This is a pilot study that will compare two systems of breast cancer follow up care and will     evaluate a number of parameters indicating quality and efficiency of care delivery as well as     patient satisfaction with care. Approximately 100 breast cancer patients who have completed     the acute phase of treatment will be randomized to one of two follow up care plans.   "
150893|NCT01308762|"     To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed     Mycobacterium obuense) in melanoma cancer patients.   "
150894|NCT01308749|"     The investigators propose to conduct this pilot study to evaluate oxytocin as a supplemental     treatment for improving social difficulties in individuals with autism.   "
150895|NCT01308736|"     The investigators will randomize smokers to receive 1) Varenicline + smoking     cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling.     Neither the participants nor the research therapists/evaluators will know to which condition     (active or placebo pill) the participants have been assigned i.e., a double-blind study). The     medication and weekly counseling will occur for 28 days. Participants will complete     assessment measures just before the start of treatment (baseline), at the end-of-treatment,     at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use     between treatment groups.   "
150896|NCT01308723|"     This open-label study will assess the safety, efficacy and pharmacokinetics of RO5323441 in     combination with sorafenib in patients with advanced or metastatic hepatocellular carcinoma     previously untreated with systemic therapy. In the dose-finding Part I, cohorts of patients     will receive escalating doses of RO5323441 intravenously (iv) every 2 weeks in combination     with sorafenib 400 mg orally twice daily. In the exploratory Part II, patients will be     randomized to receive either the previously established dose of RO5323441 iv every 2 weeks     plus continuous oral sorafenib or sorafenib alone. Anticipated time on study treatment is     until disease progression or unacceptable toxicity occurs. For patients in the sorafenib arm     with disease progression crossover to combination treatment with RO5323441 will be allowed.   "
150897|NCT01308710|"     Children with high cholesterol levels are especially vulnerable and are at high risk for     early onset coronary heart disease (CHD). Endothelial dysfunction, the earliest phase of CHD,     is present in children with elevated cholesterol levels as early as 8 years of age. The long     term objective of this study is to develop dietary interventions for the prevention and     treatment of endothelial dysfunction in children with common lipid disorders including     familial hypercholesterolemia (FH) and familial combined hyperlipidemia (FCH). Increasing     evidence suggests that the Mediterranean diet and ω-3 fatty acids found in fish have     cardioprotective effects. The specific aims of the study are to: determine whether a     Mediterranean diet alone or combined with ω-3 fatty acid (eicosapentaenoic acid)improves     endothelial function; evaluate the effects of the dietary interventions on lipids and     lipoprotein subclasses; evaluate the effects of the dietary interventions on biomarkers for     oxidative stress and inflammation. This study is a randomized, double-blind,     placebo-controlled clinical trial that includes 34 children (ages 8-17) treated with the     Mediterranean diet and ω-3 fatty acid supplements. A dietary educational behavioral     intervention will be conducted over 6 months with individual counseling and group sessions.     Endothelial function will be measured noninvasively by high resolution ultrasound of the     brachial artery at baseline, 6, 12, 18 and 24 weeks. This study is unique because it is a new     intervention designed for children at high risk for early CHD with a dietary component and     supplementation with ω-3 fatty acids. If effective, this intervention would be broadly     applicable in the community and lend valuable insight about dietary therapy to prevent the     progression of CHD in hyperlipidemic children.   "
150899|NCT01308684|"     This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in     combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the     dose-finding part, patients will receive intravenous escalating doses of RO5323441 in     combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part,     patients will be randomized to receive the established dose (from the dose-finding part) of     RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue     treatment with RO5323441 and Avastin on the study until evidence of progressive disease or     unacceptable adverse events happen. In the efficacy-finding part, patients will receive study     treatment until disease progression or death.   "
156665|NCT01233388|"     The aim of this proposal is to pioneer the implementation and evaluation of a novel patient     centered text messaging vaccine adverse event surveillance network.   "
150903|NCT01308632|"     Indication:      Subjects with glioblastoma at first relapse after surgery, radiotherapy and first-line     temozolomide (TMZ).      Objectives:        1. Phase I endpoint:           - To determine the maximum tolerated dose (MTD) of CPT-11 administered on days 8 and 22          in combination with a fixed, continuous, and metronomic regimen of TMZ, given in 28-day          cycles.        2. Phase II endpoints:      Primary endpoint: Progression-free survival at 6 months. Secondary endpoints: Response rate,     toxicity profile, overall survival.      Complementary studies:      To assess the effect of treatment on plasma concentration of thrombospondin-1 (TSP1), soluble     VEGF receptor 1 (sVEGF-1) and VEGF-A, and their correlation with clinical outcome.        -  To assess the correlation between immunohistochemical expression of PTEN and MGMT          proteins, and clinical outcomes.   "
150904|NCT01308619|"     The objective of this study is to determine the clinical effects of doxycycline 40 mg (30 mg     immediate release and 10 mg delayed release beads) capsules (Oracea®) as compared to placebo     in the skin of adults with papulopustular rosacea and to identify a correlation, if any, with     rosacea-related inflammatory markers.   "
150905|NCT01308606|"     The purpose of this study is to compare absorption of TMC435 formulated as 2 different types     of capsules. After that, the absorption of one chosen TMC435 capsule will be compared when     taken under fasting conditions or together with a standard or a high-fat meal. This will be     done in healthy volunteers.   "
150906|NCT01308593|"     Investigation into brow aesthetics using Botox in Conjunction with Juvederm XC as evaluated     by patient satisfaction   "
150907|NCT01308580|"     Primary Objective:      - To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m²     (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants     with metastatic castration resistant prostate cancer (mCRPC) previously treated with a     docetaxel-containing regimen.      Secondary Objectives:        -  To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was          better tolerated than Cabazitaxel 25 mg/m².        -  To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:             -  Progression Free Survival (PFS) defined as the first occurrence of any of the               following events: tumor progression per Response Evaluation Criteria In Solid               Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or               death due to any cause;             -  PSA Progression;             -  Pain progression;             -  Tumor response in participants with measurable disease (RECIST 1.1);             -  PSA response;             -  Pain response in participants with stable pain at baseline.        -  To compare Health-related Quality of Life (HRQoL).        -  To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.   "
150908|NCT01308567|"     Primary Objective:        -  To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20          mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS)          in participants with metastatic castration resistant prostate cancer (mCRPC) and not          previously treated with chemotherapy.      Secondary Objectives:        -  To evaluate safety in the 3 treatment arms.        -  To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for:             -  Progression Free Survival (PFS) (RECIST 1.1)             -  Tumor progression free survival (RECIST 1.1)             -  Tumor response in participants with measurable disease (RECIST 1.1),             -  PSA response             -  PSA-Progression free survival (PSA-PFS).             -  Pain response in participants with stable pain at baseline             -  Pain progression free survival             -  Time to occurrence of any skeletal related events (SRE)        -  To compare Health-Related Quality of Life (HRQL).        -  To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.   "
150909|NCT01308554|"     The purpose of this study is to determine whether injection of bupivacaine into the TAP is     effective in the treatment of post operative pain after laparoscopic gastric bypass   "
150910|NCT01308541|"     The purpose of this study is to explore the pharmacokinetics (PK) and pharmacodynamics (PD)     of LUSEDRA® administered as a continuous infusion or bolus compared with continuous infusion     of propofol injectable emulsion.   "
150911|NCT01308528|"     The purpose of this study is to compare the safety and security and efficacy of sodium     enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane     (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop     Thromboembolic Disease Undergoing Geral Abdominal Surgery.   "
150912|NCT01308515|"     The purpose of this study is to compare the performance of two FDA-cleared tibial bearings     (replacement for cartilage in the knee) by collecting data on patients through 3 years of     follow-up.   "
150913|NCT01308502|"     The purpose of this study is to evaluate the utility of a minimally invasive nasopharyngeal     pH probe for the diagnosis of laryngopharyngeal reflux (LPR) in children with airway     compromise; to determine whether it is comparable to the gold standard esophageal pH probe in     identifying LPR in this population; and to correlate results of pH testing with validated     questionnaires. Our hypothesis is that a nasopharyngeal pH probe is equivalent to an     esophageal probe in identifying laryngopharyngeal reflux.   "
150914|NCT01308489|"     This randomized clinical trial studies minimally invasive surgery in treating patients with     spinal tumors. Posterior spinal tumor resection and anterior and posterior spinal tumor     resection are less invasive types of surgery for spinal tumors and may have fewer side     effects and improve recovery   "
150915|NCT01308476|"     6 months open label non-interventional observational study acc to § 4, section 23 and § 67,     section 6 German Medicines Act with two parallel groups        1. the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram        2. the control group not receiving a daily SMS reminder   "
150916|NCT01308463|"     The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented     at the two year or next scheduled follow-up period for the early-enrolled patients.   "
150917|NCT01308450|"     This study is being conducted to enhance and extend the clinical utility of the Quotient®     ADHD System Adolescent and Adult Version Test by adding large numbers of well-screened     controls to the existing Quotient® ADHD System database of adolescents and adults (ages     15-55).   "
151283|NCT01303653|"     Gastrointestinal leaks or perforations are currently treated through either open or     laparoscopic surgical procedures. The purpose of this research is to determine whether new     endoscopic tools are safe and effective in the treatment of such conditions and can overcome     the need of invasive surgical procedures.   "
150918|NCT01308437|"     This is an open label, randomized, parallel group comparison of the immunogenicity safety of     Wockhardt's human insulin and isophane insulin compared with the Novo Nordisk's yeast based     human insulin products (marketed in USA) in type 1 diabetics.      There are two phases of the study, which are as follows:        1. Phase 1 is a comparative phase in which there will be 2 arms (which are described in the          section below).        2. Phase 2 is a follow up phase only applicable to Wosulin Arm.      The study will last for 54 weeks for the patients enrolled in Wosulin arm and approximately     28 weeks for the patients enrolled in the comparator arm.      Two hundred and forty two patients will be enrolled considering an estimated dropout rate of     15% for a sample size of approximately 105 evaluable patients per arm. The total planned     enrollment period for this study is approximately 3 months (90 days).   "
150919|NCT01308424|"     The purpose of this study is to determine if a new treatment is effective for the treatment     of recurrent symptomatic oral herpes virus infections.   "
150920|NCT01308411|"     Asthma affects 6% of the UK population and costs the NHS 1 billion pounds per year. £473     million alone is spent on inhaled steroid treatment which is designed to reduce inflammation     in the breathing tubes.      Unfortunately knowing whether a patient is on just the right amount of steroid treatment is     difficult, as asthma is a variable disease and the measures currently used to decide on     increasing or decreasing steroid treatment bare little resemblance to the actual amount of     inflammation present. Doctors may not reduce treatment as swiftly as necessary if a patient's     asthma is well controlled because of concern over asthma attacks; this can result in     potential over treatment with inhaled steroids. Although steroid treatment is safe, side     effects can occur, and costs are large, so a strategy helping avoid over treatment would be     beneficial both to patients and to the NHS.      As the investigators can more accurately measure airway inflammation present in the breathing     tubes, using a chemical called nitric oxide present in a patient's breath, the investigators     might be able to more accurately predict which patients could safely reduce their steroid     treatment. Measuring nitric oxide is simple, and involves breathing into a special machine     (similar to a roadside breathalyser). In this study the investigators will measure nitric     oxide in patients with well controlled asthma, and reduce their asthma treatment by 50%. The     investigators will then follow up the patients and remeasure their nitric oxide. At the end     of the study the investigators will see if measurements of nitric oxide predicted which     patients could safely step down their treatment. If successful this could help reduce the     overall cost to the NHS of inhaled steroids and reduce steroid associated side effects.   "
150921|NCT01308385|"     Despite enormous progress insufficient postoperative pain management remains a frequent     problem in the early postoperative phase after surgery. Furthermore, the pain that persists     after healing of the surgical wound is a large, but often unrecognized, clinical problem and     it is estimated that 5-10% of those undergoing surgery will develop severe persistent pain     leading to chronic disability and psychosocial distress.      Conditioned Pain Modulation (CPM), also known as the phenomenon pain-inhibits-pain, is a     reduction in pain somewhere on the body in response to the application of a second painful     stimulus outside the painful area. In recent years, the CPM has been identified as a     psycho-physical measure with clinical relevance in characterizing the individual's ability to     modulate pain and consequently the individual's disposition to acquire painful conditions.      The purpose of this study is primarily to assess the relationship between CPM efficacy and     clinical postoperative pain (postoperative pain intensity, use of analgesics, the intensity     of secondary hyperalgesia and allodynia, and the incidence of persistent postoperative pain)     associated with minimally invasive repair of pectus excavatum. In addition, the study aims at     identifying other patient- and/or surgery-related factors affecting the course of     postoperative pain.      Hypothesis:      - The greater the positive difference between the experimental pressure pain threshold (kPa)     measured before and after application of a second painful stimulus (Cold Pressor Test), the     lower the risk of developing persistent postoperative pain.      Secondary hypotheses        -  The greater the positive difference between the experimental pressure pain threshold          (kPa) measured before and after application of a different experimental painful stimulus          (Cold Pressor Test) lower the pain intensity in the early postoperative period.        -  The greater the positive difference between the experimental pressure pain threshold          (kPa) measured before and after application of a different experimental painful stimulus          (Cold Pressor Test), the shorter duration of early postoperative pain.        -  The greater the positive difference between the experimental pressure pain threshold          (kPa) measured before and after application of a different experimental painful stimulus          (Cold Pressor Test), the lower the usage of epidural analgesia (mg / ml).        -  The larger the positive difference between the experimental pressure pain threshold          (kPa) measured before and after application of a different experimental painful stimulus          (Cold Pressor Test) the lower consumption of oral analgesics (mg / day).        -  Severe acute pain in the early postoperative period (postoperative days 0-3) is          positively associated with the development of persistent postoperative pain (6 months          postoperatively).        -  Presence of preoperative pain and / or high postoperative use of analgesics and / or          high pain intensity during the first 6-8 weeks postoperatively predicts pain 6 months          postoperatively.        -  The higher pain intensity and discomfort associated with brush-evoked allodynia and / or          pinprick (Von Frey) secondary hyperalgesia the greater the risk for developing          persistent postoperative pain (6 months postoperatively).        -  High levels of preoperative catastrophizing (assessed on the day of admission) is          related to the severity of acute pain (rated third postoperative day) and chronic pain          (assessed 6 months postoperatively), even if controlled for depression and anxiety.        -  The degree of preoperative positive and negative emotions (as assessed on the day of          admission) is related to the degree of acute pain (rated third postoperative day) and          chronic pain (assessed 6 months postoperatively) so that negative emotions are          associated with high levels of pain, while positive feelings are related to low levels          of pain.        -  The study population does not differ significantly from the normal population in terms          of personality traits (emotional reactions, extraversion, openness to experience,          friendliness, conscientiousness).        -  The study population does not experience a significant change in personality traits          during the first 6 months after surgery.        -  The quality of life and self-esteem is lower among patients who develop persistent          postoperative pain compared with pain patients.        -  Quality of life and self-esteem improve as a result of minimally invasive repair of          pectus excavatum.   "
150922|NCT01308372|"     The purpose of this study is to evaluate the proportion of patients which present a high     cardiovascular risk estimated by the SCORE scale, in general practice consultations of the 7     French regions (Paris area, North-East, Paris basin, West, South-West, South- East,     Mediterranean area)   "
150923|NCT01308359|"     The purpose of this study is to investigate the hypothesis that glucose administration     increases fetal movement perception by the pregnant woman.   "
150924|NCT01308346|"     The target enrollment goal for the trial was to enroll 36 subjects. However due to a     challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the     trial was initiated in June 2011.      To evaluate the following in participants undergoing coronary artery scaffolding/stenting for     significant coronary artery disease:        -  The acute (post-implantation) effect of an implanted bioresorbable vascular scaffold          (BVS) or metallic drug eluting stent (mDES) on coronary blood flow and physiological          responsiveness of the target coronary artery        -  The long-term (2 years) effect of an implanted BVS or mDES on coronary blood flow and          physiological responsiveness of the target coronary artery   "
150925|NCT01308333|"     X-linked hypohidrotic ectodermal dysplasia (XLHED) is a complex genetic disorder     characterized by lack of sweat, sebaceous, submucous, Meibomian and mammary glands, sparse     hair and eyebrows, and oligodontia. Insufficient function of the respective glands may lead     to chronic inflammatory processes in airways and eyes of the affected individuals. The     investigators will quantify sweat glands of XLHED patients, assess chronic conjunctivitis and     blepharitis in conjunction with quantitative and/or qualitative alterations of lacrimal fluid     in these subjects, evaluate lung function and assess chronic inflammatory processes in the     airways by NO measurements. The data should provide a basis for genotype-phenotype     correlations.   "
150926|NCT01308320|"     Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general     anaesthesia through binding to its receptors in the brainstem. However, it has not been     proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during     emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the     relationship between fentanyl doses and cough suppression during emergence from sevoflurane     anaesthesia.   "
150927|NCT01308307|"     Purpose: : This study was performed to compare the accuracy of non-cycloplegic     photorefraction with cycloplegic refraction in detection of refractive amblyopia risk factors     and determine some corresponding beneficial cut points.      Method: In this diagnostic accuracy study, right eyes of 185 children (1 to 14 years)     underwent first non-cycloplegic photorefraction (with PlusOptix SO4 photoscreener) and then     cycloplegic refraction from October 2009 to August 2010. Based on the cycloplegic refraction     results, hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D)     were set as criteria based on AAPOS guidelines. The difference in detection of refractive     amblyopia risk factors between the two methods was the main outcome measure.   "
150928|NCT01308294|"     The purpose of this study is to determine whether vaccination with tumor antigenic peptides     and both IMP321/LAG-3 and Montanide adjuvants can induce an immune response in melanoma     patients and to assess the safety and tolerability of this vaccination. Tumor responses     following this vaccination will also be documented.   "
150929|NCT01308281|"     This study is designed as a prospective, randomized, multi-center trial to demonstrate an     inequality between IVUS-guided versus angiography-guided implantation of everolimus-eluting     stents(EES) at long lesions(> 28 mm) in clinical outcomes at 12 months as a primary objective     and safety of 6- month dual antiplatelet therapy following EES implantation in comparison     with a 12-month dual antiplatelet therapy.   "
151300|NCT01303432|"     The purpose of this study is to determine whether the daily eating of a yogurt supplemented     with Mobile is effective in improving joint function and quality of life of individuals with     low intensity gonalgia.   "
150931|NCT01308255|"     This is a placebo controlled randomised clinical trial.Patients attending Yorkshire Early     Arthritis Clinics and diagnosed with rheumatoid arthritis with symptom duration of 3−12     months will be recruited. They will be randomised to blinded therapy with either methotrexate     and intravenous corticosteroid at baseline, or methotrexate and intravenous infliximab     according to the standard treatment regime. Patients will be followed regularly, and at each     visit, if the patients are not in remission, they will be given an intramuscular injection of     corticosteroid. After 26 weeks, all patients will be unblinded and those with an inadequate     treatment response will be treated according to a dose escalation algorithm until they     achieve remission. Those in remission will continue on blinded therapy and if 6 months of     remission is achieved the intravenous agent (infliximab or placebo) will be withdrawn.   "
150932|NCT01308242|"     Fibroblast Growth Factor 23 (FGF23) is a molecule that has been implicated in the homeostasis     of phosphorus. Elevated FGF23 levels are well-documented in patients with CKD and are     inversely correlated with Glomerular Filtration Rate (GFR). FGF23 levels are also predictive     of progression of CKD and predict mortality in CKD. Although studies in normal individuals     suggest that phosphorus intake is related to FGF23 levels, the effect of dietary and     pharmacologic phosphate restriction on FGF23 levels in patients with CKD has never been     reported. Our objectives are to determine if phosphate reduction through the use of     non-calcium based phosphate binder will decrease serum FGF23 levels. The investigators will     also be investigating associations of elevation in FGF 23 levels with commonly encountered     co-morbidities in CKD patients such as Coronary Artery Disease, Diabetes Mellitus, and     Hypertension.   "
150933|NCT01308229|"     The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting     Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in     native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side     branch reference vessel diameter of 2.0-3.0 mm.   "
150934|NCT01308216|"     The aim of this study is to determine the efficacy of transcranial laser therapy applied in     automatic noncontact scanning mode for improving functional disability in patients with     hemiplegia from ischemic stroke undergoing a rehabilitation program.   "
150935|NCT01308203|"     -  Clinical studies with statins have shown that patients that suffered a cardiovascular          event have a high residual risk. Residual risk decreases with the attaining of          progressive lower LDL-C levels.        -  In patients treated with statins, HDL-C level is an independent inverse predictor of          subsequent CV and coronary plaque progression, even when LDL-C levels are less than 70          mg/dL.        -  Therefore the purpose on this study is to assess the lipid efficacy on lipid profile and          effects on HDL-C metabolism and function of the extended release niacin/laropiprant          combination added to usual therapy in very high risk patients with cardiovascular          disease and low HDL-C that did not achieve the optional very low LDL-C or non-HDL-C          goals   "
150936|NCT01308190|"     The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME). The     technique involves a low anterior rectal or colo-anal resection, very often associated with a     protective stoma or abdominal-perineal resection with permanent colostomy. Transanal     endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal margin, with     minimal postoperative morbidity and mortality. Recent studies of T1 rectal adenocarcinomas     consider TEM to be the technique of choice. However the treatment of T2 rectal cancers     remains controversial. Chemotherapy and radiotherapy (CT/RT) has achieved a concomitant     reduction in local recurrence and an increase in survival.      Hypothesis: Patients with rectal adenocarcinoma less than 10 cm from the anal margin and up     to 4 cm in size, staged after endorectal ultrasound and MRI as T2 or superficial T3     N0-M0-N0-M0, who underwent surgery after preoperative local chemoradiotherapy (TEM), achieve     effective results in terms of local recurrence similar to radical surgery (TME).      OBJECTIVES:      Primary: To compare the results of local recurrence at 2 years in patients treated with     preoperative chemoradiotherapy and TEM and in patients treated with conventional radical     surgery (TME).      Secondary: To analyse the 3-year survival results in patients treated with CT/RT.      Methodology: Multicenter clinical trial in a calculated sample of 173 patients.   "
150937|NCT01308177|"     -  Endoscopic submucosal dissection (ESD) is widely indicated to treat gastric adenomas and          early gastric cancer (EGC).ESD is able to obtain en bloc resection of larger specimens.          However, ESD has more frequent complications (delayed bleeding, ulcer healing, ulcer          pain, and etc) due to a more complex procedure. To prevent delayed bleeding, to induce          rapid ulcer healing, and to control the ulcer pain acid-suppressing agents (PPI, H2RA)          are generally administered. although PPIs are widely indicated as first-line drugs for          peptic ulcers, PPI drugs are not fully superior to H2RAs or other combination drugs for          treatment of iatrogenic ulcer healing and delayed bleeding.        -  Ecabet sodium (ES)is a widely used mucoprotective agent for the treatment of gastric          ulcers. Recently, one study showed the additional benefits of using ES in combination          with the PPI after ESD. however, this study did not show the difference of delayed          bleeding and the benefit of ulcer pain control. thus, our study prospectively evaluated          the difference of delayed bleeding and the benefit of ulcer pain control after ESD.   "
150938|NCT01308164|"     The objective of this feasibility study is to evaluate the efficacy and safety of automated     determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration     and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1     diabetes.      Study design:      Prospective study with two segments: (i) Pilot study, 30 days trial evaluating the MD-Logic     pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing MD-Logic     pump advisor to the standard of care of patients with type 1 diabetes. The RCT will be     initiated after the pilot segment (including data analysis). The pilot segment will include     15-30 pediatric patients. In the RCT, up to 105 (50 minors under this protocol and 55 adults     under a separate protocol)eligible subjects will be enrolled to allow for 92 valuable     subjects at the end of the study. The subject population will be randomly assigned 1:1 to     either the intervention group or control group. At this pediatric sub study approximately 50     patients will participate and at the separate Adults study additional 55 adult patients will     participate.   "
151773|NCT01297166|"     The purpose of this study is to evaluate the anti-psoriatic effect of LEO 27989 ointment and     calcipotriol plus LEO 27989 ointment, using the psoriasis plaque test modified from the     method developed by KJ Dumas and JR Scholtz.   "
150939|NCT01308151|"     Aim:      To adapt and develop a culturally appropriate psychological intervention and test its     feasibility, and acceptability for the patients presenting to general hospital following     self-harm in Karachi Pakistan.      Primary hypothesis:      Patients who receive cognitive behavioral therapy will show significant decrease in suicidal     ideation as compared to patients with treatment as usual.      Design:      Randomized Control Trial      Setting:      Medical Departments of General Hospitals in Karachi.      Participants:      A total of 200 self harm patients will be randomized to psychological intervention and     treatment as usual arm.      Intervention:      Culturally Adapted Cognitive Behavioral Therapy (CBT)      Outcome measure:      Beck Suicidal Ideation Scale   "
150940|NCT01308138|"     The main focus of the project is to determine to what degree myocardial energy metabolism is     linked to impaired function in human cardiomyocytes, whether exercise training and remote     ischemic preconditioning can restore cardiomyocyte function and whether this is linked to     improved mitochondrial and cell function.   "
150941|NCT01308125|"     Pressure intermittent coronary sinus occlusion (PICSO) in patients with coronary artery     disease improves collateral flow index to higher than 30%. PICSO used in this patient     population is safe, feasible and effective. Safety, feasibility and effectiveness will be     tested by periprocedural and logistic data.   "
150942|NCT01308112|"     The purpose of this study is to compare the presence of Plasmodium infection in parturient     women who antenatally received a combination of iron-fortified foods with iron supplements     versus iron-fortified foods only.   "
150943|NCT01308099|"     The purpose of this study is to see if people with Postural Tachycardia Syndrome (POTS) have     different levels of certain chemicals in their blood than people who don't have POTS. This     study will test whether the blood vessels of people with POTS will react differently to     certain tests than people without POTS.      The hypothesis of the study is:      Patients with POTS will have vascular endothelial dysfunction compared with control subjects.   "
150944|NCT01308086|"     The purpose of this study is to compare whether a 3-month treatment is at least not inferior     to a 6-month treatment (FOLFOX-4 6 vs. 12 cycles or XELOX 4 cycles vs. 8 cycles) in terms of     RFS in patients with high risk stage II or stage III radically resected colon cancer.   "
150945|NCT01308073|"     The investigators aim to show, whether all middle molecules are included in the clearance and     whether this clearance is stable until 72 hours.   "
150946|NCT01308060|"     This double-blind study has two parts for each subject (same population):      Part A: initial treatment in CL (placebo-controlled):        -  To assess the efficacy, safety and duration of effect of Azzalure® compared to placebo          in the improvement of moderate to severe Lateral Canthal Lines.        -  To assess the subjects' level of satisfaction with the appearance their Lateral Canthal          Lines compared to placebo.      Part B: repeated treatment in CL with or without GL (active treatment, up to 1 year):        -  To assess safety of Azzalure® following repeated administration in the improvement of          moderate to severe Lateral Canthal Lines.        -  To assess the safety of Azzalure® when used concomitantly for improvement of moderate to          severe Lateral Canthal Lines and Glabellar Lines.        -  To assess the subjects' level of satisfaction with the appearance their Lateral Canthal          Lines.   "
150947|NCT01308047|"     The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine     with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for     Orthopedic Procedures in the Lower Limbs.   "
150948|NCT01308034|"     The purpose of this study is to determine the safety of continuous dosing of sunitinib in     association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor)     sarcomas who cannot be treated by surgery.      The primary objective of the study is to determine the maximum tolerated dose (MTD) of     continuous dosing of sunitinib in association with radiotherapy in patients with non GIST     sarcomas who cannot be treated by surgery.      This study is a multicentre, open-label phase I with dose escalation : 3 dose levels.      3-6 patients will be included at each dose level.3-18 patients will be included in the study.   "
150949|NCT01308021|"     The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived     peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.   "
150950|NCT01308008|"     The goal of the proposed research is to test whether a long-term exercise program in     sedentary Veterans with diabetes will produce sustained improvement in mobility performance     and physical activity. In this proposed research, 240 sedentary older adult diabetics (aged     60 and over) will be randomly allocated into a customized, primarily home-based,     functionally-oriented exercise program with nurse support intervention (I) group versus a     flexibility and toning, health education control (C) group, and test outcomes in functional     mobility and physical activity at 4 weeks, 6 months and one year. This research can lead to     an exercise/PA enhancement program that can coordinate with VA outreach programs, targeting     older Veterans who are not in the immediate vicinity of a major VA site. Ultimately, this     should create a model to which physicians and other providers could refer comorbid diabetes     patients.   "
150951|NCT01307995|"     The aim of this study is to evaluate the reduced incretin effect observed in patients with     T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and     iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post     partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in     patients with other forms of DM. The investigators estimate that approximately 90 % of the     patients with GDM re-establish a NGT 2-3 months post partum. This particular group of     patients provides a unique possibility for demonstrating the reversibility of the reduced     incretin effect in relation to optimal glycaemic control.   "
150952|NCT01307982|"     This trial is a randomized controlled trial of two standard anti-reflux procedures, Nissen     fundoplication versus gastrojejunal feeding tubes (GJ tubes), in children and adolescents     with functional and intellectual impairment who have gastrostomy feeding tubes and medically     refractory or severe gastroesophageal reflux disease (GERD). This is a pilot study to     establish feasibility before initiating a multi-centered study.   "
150953|NCT01307969|"     This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated     ropivacaine formulation for dental anesthesia.   "
151774|NCT01297153|"     The purpose of this study is to document the safety and efficacy of primary IOL implantation     in children below 2 years of age undergoing congenital cataract surgery.   "
150954|NCT01307956|"     RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high energy x-rays to kill tumor cells. Giving monoclonal antibody     therapy together with chemotherapy and radiation therapy before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving panitumumab, combination     chemotherapy, and radiation therapy together before surgery works in treating patients with     advanced esophageal or gastroesophageal (GE) junction cancer   "
150955|NCT01307943|"     Mindfulness-based stress reduction (MBSR) is a group program in which participants are taught     to be mindful or present-focused. MBSR programs consist of instruction in a variety of     mindfulness meditations including body scan, sitting meditation, mindful yoga, and discussion     of these practices. Our study purpose is to develop and conduct a pilot mixed-methods     randomized controlled trial (RCT), combining clinical outcomes, qualitative interviews, and     brain imaging to assess the impact of the intervention on children with mental health     challenges.   "
150956|NCT01307930|"     This study will find how weight affects the dosing of a drug called anidulafungin. Currently,     the amount of anidulafungin a patient receives is the same regardless of the patient's     weight. BMI groups were for enrollment purposes only and not used for ordinal data analysis.   "
150957|NCT01307917|"     Diabetes is the most common metabolic disease of childhood. Vascular disease is a leading     complication of diabetes, and attempts to maintain close glycemic control do not prevent the     sequelae that claim the lives and quality of life of millions of diabetics each year. Up to     forty percent of patients with diabetes mellitus ultimately develop diabetic nephropathy, the     most common cause of end-stage renal disease requiring dialysis in the US. Flavonoid-rich     diets are a promising intervention to prevent the endothelial dysfunction that apparently     leads to this deadly complication. The mechanisms are still unclear but probably involve     nitric oxide synthesis. The investigators hypothesize that early maintenance of the integrity     of renal vasculature will significantly improve the lifelong prognosis for patients with     diabetes. Flavonoids with anti-inflammatory and antioxidant activities could be used to     protect endothelial function, and together with good glycemic control, prevent the     development and progression of nephropathy. The investigators aims are to:        1. compare endothelial function by studying reactive hyperemia, nitric oxide, and          proinflammatory factors in adolescents (12-21 years old) with diabetes versus healthy          sex- and age-matched control subjects.        2. identify early markers in urine for vascular endothelial injury.        3. examine the effects of flavonoids on vascular function, urine nitric oxide, and          proinflammatory factors in patients with diabetes mellitus.   "
150958|NCT01307904|"     The main objectives of this study is to measure the composition of five common types of dates     (Fara'd, Lulu, Abu ouma'n, Dabbas and Khalas) and to calculate their Glycemic Indices (GI) of     these dates tested in healthy and diabetic subjects. Thirteen healthy volunteers and ten     subjects with type 2 diabetes mellitus were enrolled in the study.      The dates' flesh composition analysis showed that the dates contain a high percentage of     carbohydrate (total sugars, 65-68%).      The measured mean glycemic indices of the dates among healthy individuals were 54.0, 53.5,     46.3, 49.1 and 55.1 for Fara'd, Lulu, Abu Ouma'n, Dabbas and Khalas, respectively.     Corresponding mean glycemic indices among individuals with type 2 diabetes were very similar     46.1, 43.8, 51.8, 50.2, and 53.0. Thus the tested five varieties of the dates are classified     as low glycemic index food items.   "
150959|NCT01307891|"     Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer     deaths in American women. Metastatic disease including metastatic breast cancer unfortunately     remains incurable. One reason is due to the inability to develop specific therapies for     specific cancer subsets.      The use of modern genomic techniques has significantly enhanced our recent understanding of     breast cancer biology. Five distinct breast cancer subsets have been recognized, one of which     is basal-like breast cancer. Basal-like breast cancer is typically estrogen receptor (ER)     negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2     (HER-2-Neu) negative. This is referred to as triple negative breast cancer or TBNC. TBNC     represents a significant proportion of breast cancer patients (10-20%) and has a poor     prognosis with no targeted approach to therapy as of yet.      Tigatuzumab is a humanized monoclonal antibody targeting a death receptor on the breast     cancer cells. Previous studies have shown that combining antibodies with selected     chemotherapy agents have induced tumor cell death. The hypothesis of this study is to use     tigatuzumab and combine it with Abraxane to serve as a targeting agent in metastatic TBNC     patients.   "
150960|NCT01307878|"     Evaluation of new adjuvant chemotherapy for unresectable liver metastasis of colorectal     cancer without bleeding, obstruction, etc.   "
150961|NCT01307865|"     The purpose of this study is to examine the effect of Sculptra Aesthetic on the cosmetic     rejuvenation of the midface complex. The investigators plan to both qualitatively determine     the restoration of midface architecture as well as quantitatively document the change in     midface volume by employing three-dimensional (3D) surface imaging which critically analyzes     volumetric tissue changes. Our hypothesis is that patients who receive Sculptra Aesthetic     injections will experience significant improvement in facial midface volume restoration.        -  Measure the midfacial volumetric correction from Sculptra Aesthetic treatment, using          three-dimensional digital surface imaging        -  Determine the mean change from baseline in facial contour via quantitative volumetric          measurements        -  Correlate volumetric correction with clinical improvement as measured by the Facial          Lipoatrophy Panel grading system        -  Correlate the mean volumetric change in midfacial treatment area with the amount of          product used        -  Obtain photographs pre- and post-treatment for the purpose of providing a subject visual          aid during the course of treatment        -  Collect safety data   "
151009|NCT01307215|"     Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP     block is a procedure used to reach the nerve endings in the abdominal wall so that there is a     reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will be     injected after surgery. The aim of this study is to determine the effect of changes in the     volume of the injection.   "
150963|NCT01307839|"     Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural     placement in laboring parturients1. Skin infiltration, although brief, can be very stressful     and painful for patients.2 This initial discomfort may cause patient anxiety, thus increasing     the pain and decreasing the satisfaction with the procedure. To reduce this discomfort,     various topical alternatives have been investigated with varying degrees of success.1-4 Now     that a topical mixture of lidocaine that is safe and effective is available, the     investigators would like to determine if it can reduce the pain of skin infiltration in     particular and epidural placement as a whole.   "
150964|NCT01307826|"     The purpose of this study is to compare classical massage and massage based on the tensegrity     rule in treating people with painful shoulder.   "
150965|NCT01307813|"     The Overstitch (Apollo Endosurgery, Austin, Texas) is an FDA cleared product which attaches     to a standard double channel endoscope. The Overstitch can place sutures under endoscopic     guidance, with the goal of reproducing standard surgical techniques. These would include     hemostasis, tissue approximation, anastomosis formation, fixation of intraluminal devices, or     repair/closure of mucosal or full thickness defects such as perforations or endoscopic     mucosal resection (EMR) sites. Knot tying of the endoscopically placed sutures is provided by     an endoscopic cinching device that passes through the channel of the endoscope.      This feasibility trial will evaluate the ability of the Apollo suturing device (Overstitch)     to endoscopically place sutures into normal mucosa, and then tie the sutures with the     cinching device. These devices have been utilized effectively in explant, live porcine, and     human cadaver colon and stomach models. In this treat and resect model, sutures would be     placed in a segment of colon or stomach that is being surgically removed via open or     laparoscopic technique for the treatment of benign or malignant disease. The sutures would be     placed in a segment of normal mucosa remote to the pathology being surgically treated. In     addition, the sutures will be placed under direct observation via laparoscopic or open     visualization. After resection of the segment of colon, it will be evaluated grossly for     level of suture placement, evidence of perforation, and quality of suture approximation with     the cinching device.   "
150966|NCT01307800|"     The purpose of this study is to determine whether at least 1 dose level of LY2140023 given to     acutely ill patients with schizophrenia will demonstrate significantly greater efficacy as     compared to placebo.   "
150967|NCT01307787|"     The purpose of this study is to evaluate the effects of a group-based exercise and     educational program for people with Rheumatoid Arthritis (RA) on physical performance and     disease-self-management.   "
150968|NCT01307774|"     To conduct a quantitative survey to measure knowledge about Human papillomavirus (HPV) and     cervical cancer, and HPV vaccine acceptability among parents of rural adolescent girls in     Mysore District, India.      Hypothesis: General knowledge and attitudes about the severity and treat ability of cancer     will predict acceptability of HPV vaccination among parents of rural adolescent girls in     Mysore, India.   "
150969|NCT01307761|"     The purpose of the investigators study is to retrospectively evaluate the predictors of     malignant thyroid nodules and established an useful scoring system based on sonographic     findings and demographic data.   "
150970|NCT01307748|"     The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how     aromatherapy works.   "
150971|NCT01307735|"     Myocarditis is an inflammatory heart disease primarily of viral origin that can lead to heart     failure and death. Despite an unfavorable long-term outcome and mortality rate as high as     50%, classification, diagnosis, and treatment of myocarditis remains controversial. The gold     standard for clinical diagnosis is direct sampling of the heart muscle, which often misses     the infected area and thus reliability of the test is questionable. While the cause and     clinical presentation of myocarditis are often unclear, inflammation of the heart muscle can     be clearly imaged by Cardiovascular Magnetic Resonance Imaging (CMR).      Due to recent international consensus on CMR protocol for myocarditis and the unique ability     of CMR to visualize cardiac structure, function, and characterize tissue, CMR has become the     primary tool for clinical assessment. This study aims to test the accuracy of CMR in the     diagnosis of myocarditis and to validate whether CMR acquired in an early stage of     myocarditis can provide incremental prognostic information. In order to effectively gather     relevant clinical data, an online, multi-centre international registry will be established     across twenty different medical institutions.      Hypotheses:        1. CMR accurately detects active myocardial inflammation in patients with myocarditis        2. CMR acquired in an early clinical stage of myocarditis provides incremental prognostic          information superior to standard clinical diagnostic tools.   "
150972|NCT01307722|"     Background and Purpose- According to our prior studies, left atrial (LA) distensibility was     associated significantly with left ventricular filling pressure in patients with acute     myocardial infarction (AMI), chronic stable angina, and severe mitral regurgitation. LA     distensibility can be used as noninvasive Swan-Ganz catheter. Additionally, it could predict     in-hospital mortality in AMI patients. In the current study, left atrial distensibility     guiding management in advanced chronic heart failure will be performed to assess whether     those management could influence long-term prognosis including mortality rate,     rehospitalization rate and the duration of rehospitalization.      Materials and Methods- Advanced chronic heart failure (HF) is defined as left ventricular     ejection fraction less than 35%, creatinine less than 2 mg/dL, and CHF NY functional class     III-IV for more than 3 months. Enrolled patients should be admitted to hospital due to heart     failure requiring adjustment of inotropic agents or diuretics within recent 6 months. Three     hundred HF cases will be recruited - 100 with sinus rhythm, and 100 with atrial fibrillation     served as LA distensibility guided treatment group (guide group) and another 100 patients,     either sinus rhythm or atrial fibrillation, served as control group. The management of guide     group will be adjusted by LA distensibility, including the dose of inotropic agents,     diuretics, beta-blocker, ACEI, and AIIB. Initially, the guide group will be followed 1 time     per 2 week at first 3 months, then 1 time per month later. The control group will be treated     by conventional management and traditional echocardiography can be performed as in-charge     doctor request. The necessity of hospitalization for heart failure will be adjusted by 2     cardiovascular specialists and all patients admitted for heart failure will be managed by the     same one cardiovascular specialist (Shih-Hung Hsiao). The total duration of follow-up will be     2 years. For life-threatening heart failure, intravenous nitroprusside drip under continuous     A-line monitor, percutaneous coronary intervention, Swan-Ganz catheter insertion,     intra-aortic balloon pump, and ECMO can be done according to the order of in-charge doctor.     The primary end-point will be all-cause mortality. The second end-points will be heart     failure with hospitalization and the duration of each hospitalization. Additionally, the     ratios of medication changes in 2-year follow-up, including diuretics, inotropic agents, beta     blockers, ACEI, and AIIB, will be assessed. Analysis will also be performed to estimate the     trends of heart function (either systolic or diastolic) and renal function during 2-year     follow-up according to whether guiding by LA distensibility is done or not.   "
151172|NCT01305096|"     The purpose of this study is to determine whether inversions (specific yoga postures in which     the heart is higher than the head) and other dynamic and static yoga postures affect heart     rate variability, oxygen uptake, blood pressure, blood parameters and other objective     measures of health, and a variety of subjective and objective measures of health in female     and male individuals in Sweden.   "
150973|NCT01307696|"     Meshes-devices using dual-sided mesh technology have been developed for the specific     indication of small ventral hernias. The design of these meshes allows introduction of a mesh     of appropriate size to cover the hernia defect, through a small incision. This technique is     very attractive for the surgeon and the patients because the mesh usually can be introduced     through a nearly invisible scar in the umbilicus. The avoidance of fixation sutures omits the     pain related to these sutures. Short-term results and patient satisfaction are very     favorable, encouraging the surgeons to continue with the technique, although long-term     results of these meshes in good quality studies are lacking.   "
150974|NCT01307683|"     The MAMAS study is built on the premise that simple recommendations for diet and exercise may     not be enough to encourage healthy weight gain during pregnancy. Psychological skills     training may be necessary to help women deal with stress and cravings; learn to regulate     difficult emotions; increase awareness; and encourage healthy eating and physical activity.     The goal of this study is to find out whether a behavioral stress reduction intervention can     help women achieve healthy weight gain during pregnancy and reduce stress.   "
150975|NCT01307657|"     The purpose of this study is to determine whether a high-fat meal affects the ability of     platelet function tests to measure platelet inhibition by clopidogrel.   "
150976|NCT01307644|"     This project will evaluate an Internet delivery strategy to address weight loss and     maintenance among rural midlife and older women.   "
150977|NCT01307631|"     This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with     recurrent or advanced endometrial cancer. Akt inhibitor MK2206 may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
150978|NCT01307618|"     This randomized phase II trial is studying how well giving vaccine therapy together with or     without recombinant interleukin-12 followed by daclizumab works in treating patients with     melanoma that has spread to other places in the body. Vaccines made from peptides or antigens     may help the body build an effective immune response to kill tumor cells. Recombinant     interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating     white blood cells to kill melanoma cells. Monoclonal antibodies, such as daclizumab, may     decrease the number of regulatory T cells (T cells that suppress the activation of the     immmune system) and may lead to a better immune response against melanoma. It is not yet     known whether vaccine therapy is more effective with interleukin-12 and daclizumab in     treating melanoma.   "
150979|NCT01307605|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Lenalidomide may stop     the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. It is not yet known     whether rituximab is more effective when given alone or together with lenalidomide in     treating patients with follicular lymphoma.      PURPOSE: This randomized phase II trial is studying rituximab to see how well it works     compared with giving rituximab together with lenalidomide in treating patients with     previously untreated follicular lymphoma.   "
150980|NCT01307592|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, oxaliplatin, and ,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell     growth in different ways. Some block the ability of cancer cells to grow and spread. Others     find cancer cells and help kill them or carry cancer-killing substances to them. Lenalidomide     may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving     rituximab and chemotherapy together with lenalidomide may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab, gemcitabine     hydrochloride, and oxaliplatin together with lenalidomide works in treating patients with     relapsed or refractory, aggressive non-Hodgkin lymphoma.   "
150981|NCT01307579|"     This randomized phase III trial studies caspofungin acetate to see how it works compared to     fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia     who are undergoing chemotherapy. Caspofungin acetate or fluconazole may help prevent fungal     infections caused by chemotherapy. It is not yet known whether fluconazole is more effective     than caspofungin acetate in preventing fungal infections in patients with acute myeloid     leukemia who are undergoing chemotherapy.   "
150982|NCT01307566|"     The main purpose of this study is to measure the evolution of hemoglobin A1c level after     treatment with CPAP in a cohort of type 2 diabetes mellitus patients with poor glycemic     control and associated moderate or severe obstructive sleep apnea.   "
150983|NCT01307553|"     The purpose of this study is to track the clinical safety and effectiveness of the     Pericardium Covered Stent in real world use.   "
150984|NCT01307540|"     Study hypothesis: light therapy may prevent oral ulcers in bone marrow recipients.      Methods: patients will be treated with either active light-emitting device or inactive     light-emitting device. Daily treatment with light therapy will start at the beginning of the     conditioning regimen and will last until day 21 post-transplant. Each daily treatment last     about 5 minutes. Patients will be evaluated for oral mucositis and oral pain level on a     weekly basis.   "
150985|NCT01307527|"     Brittle Cornea Syndrome and Ehlers-Danlos Syndrome (EDS) type VI are rare collagen-connective     tissue disorders that predispose affected individuals to the development of perforated     corneas from the mildest of eye trauma or even spontaneously. Clinical studies evaluating     riboflavin-corneal crosslinking have found that it dramatically increases corneal rigidity.     Given the success and safety of riboflavin crosslinking, the investigators believe that it     can increase the corneal stability in patients affected these disseases, preventing     perforation. It is furthermore possible, that riboflavin crosslinking will allow corneal     transplants to successfully be performed on blind eyes that have already perforated and     opacified. The purpose of the study is to determine whether corneal crosslinking can be     safely performed on individuals with Brittle Cornea Syndrome or Ehlers-Danlos Syndrome type     VI.   "
151033|NCT01306903|"     The standard heart-lung machine is a major trigger of systemic inflammatory reactions,     hemodilution, coagulopathy or organ failure. The strict reduction of blood-artificial surface     and blood-air contact might represent meaningful improvements of the extracorporeal     technology with respect to organ preservation.      The aim of this study is the evaluation of potential differences between a minimal     extracorporeal circuit (MECC) and a conventional cardiopulmonary bypass (MOPS) system.   "
150986|NCT01307514|"     The aim of this experiment is to test the pharmacodynamics and pharmacokinetics of insulin     analogs and their dependence on external and physiological alterations. The investigators     plan compare the pharmacodynamics of insulin analog delivery in regular conditions and in the     presence of increased perfusion of the delivery site, achieved by way of local warming,     movement and topical application of Capsaicin cream. The investigators will also test the     effect of local heating and topical application of Capsaicin cream on the post prandial     glucose levels following a bolus.   "
150987|NCT01307501|"     ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors     less than or equal to 3.5 cm in patients with pulmonary metastatic disease.   "
150988|NCT01307488|"     A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected     subjects in their first antiretroviral regimen and who are virologically suppressed on a     regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to     ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.   "
150989|NCT01307475|"     Freeman-Sheldon syndrome (FSS) is a rare human neuromusculoskeletal disorder present before     birth, involving primarily limb and craniofacial deformities.      The hypotheses in the present study of FSS and related conditions are: (1) FSS and related     conditions are associated with higher rates of posttraumatic stress symptoms (PTSS),     depression, and reduced quality of life than is observed in the general population; (2)     persons close to an individual with FSS or related condition suffer similarly; and (3)     current measures, which are single-disease specific (i.e., PTSS, depression, craniofacial     deformities, or limb deformities), do not capture the unique picture of FSS and related     conditions, which involve both limb and craniofacial deformities in an intellectually capable     individual.      There have been no studies looking at quality of life associated with FSS. Some authors have     looked at quality of life in persons with facial differences; other authors have looked at     bone and joint problems. Many other authors have looked at PTSS and depression caused by     health problems and bad medical experiences. No authors have looked at these problems when     they happen together, as they do in FSS. Because of the above, there may be differences in     patients that have FSS versus patients in previous quality of life studies. The study will     also develop and validate an outcomes-based quality of life survey for FSS and related     conditions.   "
150990|NCT01307462|"     This phase II trial studies how well giving fluticasone propionate, azithromycin, and     montelukast sodium (FAM) together works in treating patients with bronchiolitis obliterans     who previously underwent stem cell transplant. FAM may be an effective treatment for     bronchiolitis obliterans   "
150991|NCT01307449|"     Vaccination is the most effective way of preventing infectious diseases. Despite the success     of vaccines in general, vaccines induce diminished antibody responses and lower protection in     the elderly in particular. This could be explained by a defect in the early responses of an     ageing immune system. A better understanding of the basic immunological mechanisms that     mediate vaccine efficacy is incomplete. Such information is critical and could greatly     decrease both the cost and the time to new vaccine development particularly for the geriatric     population.      In this trial, the investigators will study the immunologic differences of two FDA approved     licensed pneumococcal vaccines between a younger and an older group. Twenty two healthy     volunteers between the age of 25-40 and sixty six healthy volunteers between the ages of     60-89 will be enrolled in the study. Each participant in the study will be given one     pneumococcal shot. Blood work will be obtained prior to vaccination, one day, three days,     seven days, fourteen days, as well as one month and six months after vaccination. Throughout     the duration of the study, the participants will be monitored for safety.   "
150992|NCT01307436|"     The primary purpose of this study was to assess whether the protection afforded by Epaxal     vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus     influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and     (measles mumps and rubella) MMR vaccines against hepatitis A was not inferior to the     protection afforded by Epaxal administered alone. The aim of the follow-up phase is to obtain     information on the long term protection afforded by Epaxal, and to compare this with an     alternative hepatitis A vaccine (Havrix).   "
150993|NCT01307423|"     The purpose of this study is to determine whether apremilast is safe and effective in the     treatment of patients with psoriatic arthritis who have not been previously treated with     DMARDs.      Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and     swollen joints, pain, physical function) in treated patients.   "
150994|NCT01307410|"     In 2010, the sponsor conducted an observational study, entitled as Nationwide Assessment of     Cardiovascular Risk Factors: Blood Pressure, Blood Lipid, and Blood Glucose, in Chinese     Patients with Type 2 Diabetes - 3B Study  which was to evaluate the level of cardiovascular     diseases (CVD) risk factor control and its regional difference in China. As a continuation,     this extension of the 3B Study is designed to assess the incidence of cardiovascular events,     cardio-renal events, and other microvascular complications, in 1, 2 and 3 years in patients     with type 2 diabetes and with high risk of (CVD) with or without existing or history of     coronary artery diseases.   "
150995|NCT01307397|"     This open-label, multicenter study will evaluate the safety and efficacy of RO5185426 in     patients with BRAF V600 mutation-positive, surgically incurable and unresectable stage IIIC     or IV metastatic melanoma. Eligible patients will receive RO5185426 (960 mg twice daily     orally) until disease progression or unacceptable toxicity occurs, with a safety follow-up of     24 months after discontinuation of the study drug.   "
150996|NCT01307384|"     This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain     survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used     in primary total hip arthroplasty.   "
150997|NCT01307371|"     The purpose of this study is to investigate the efficacy and mechanism of bone marrow     mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with     ST-segment elevation myocardial infarction (STEMI)who have undergone percutaneous coronary     intervention (PCI).   "
150998|NCT01307358|"     The purpose of this research study is to compare the interproximal plaque removal ability of     Philips Sonicare Interproximal Cleaning Device to floss (Crest Glide) and Waterpik     Waterflosser. In addition, we seek to learn more about the results of using this device on     plaque accumulation and what biological processes influence the makeup of plaque and     reduction of gingivitis.   "
150999|NCT01307345|"     This pilot project proposes to monitor real-world alcohol use using a novel technology—cell     phone videorecordings in conjunction with breathalyzer recordings—and to conduct a small     randomized study of this technology for reinforcing alcohol abstinence. Individuals with     frequent alcohol use (N = 30) will be asked to carry a study cell phone plus a handheld     breathalyzer for one month. Participants will be randomized to one of two conditions: alcohol     monitoring or alcohol monitoring plus contingency management. In both conditions, research     assistants will telephone participants on their cell phone an average of 10 times per week to     request submission of a breathalyzer sample using the video monitoring function on the cell     phone. Samples will be time and date stamped, and the video containing the breathalyzer     result will be sent to study staff via the cell phone. Participants will be compensated for     each video recorded within one hour of receiving the prompt. Participants randomized to the     contingency management condition will receive the same alcohol monitoring described above,     and they will also receive reinforcement for each alcohol negative breath sample submitted     within one hour of the prompt. Data from this pilot project will be useful for (1)     determining the feasibility of assessing alcohol use in the natural environment via     breathalyzers and cell phone technology, and (2) estimating effect sizes of a CM intervention     that reinforces alcohol abstinence using breathalyzers and cell phone technology. In an     exploratory manner, we will also evaluate the reliability and validity of the video     monitoring procedure and trends toward changes in psychosocial functioning.   "
151000|NCT01307332|"     There are two parts to this investigator sponsored trial (IST):        1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.        2. To provide serum samples for the University of Southern California (USC) ICAM125          lymphocyte recovery study.   "
151001|NCT01307319|"     The purpose of this study is to assess the safety and efficacy of an investigational nasal     aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal     allergic rhinitis in children (6-11 years of age).   "
151002|NCT01307306|"     The central aim of this application is to determine whether improved outcomes with tight     euglycemic control are due to insulin-specific responses. The investigators hypothesize that     improving insulin resistance will lead to decreased inflammatory and hypermetabolic     responses, as well as restored glucose metabolism, and so result in improved clinical outcome     of severely burned patients.   "
151003|NCT01307293|"     The purpose of the study includes:        1. To develop a treatment manual and pilot test this treatment intervention which is          designed to prevent and reduce psychological distress in parents who have infants          hospitalized in the neonatal intensive care unit (NICU).        2. To conduct a treatment intervention study in which parents of NICU infants will receive          a 6-12 session treatment designed to reduce psychological distress, and to compare          outcomes with parents who do not receive the intervention.      We hope to learn whether or not a simple psychotherapeutic and psychoeducational intervention     offered to parents of NICU infants can prevent or minimize the development of symptoms of     psychological distress in parents, including symptoms of anxiety and depression and     posttraumatic stress disorder (PTSD).   "
151004|NCT01307280|"     The study investigated the effectiveness and cost-effectiveness of a cognitive and behavioral     weight management program, complemented by an interactive Web site and brief telephone     coaching, implemented among TRICARE non-active-duty beneficiaries.      A total of 1,755 participants from four Midwestern states were randomized to one of three     randomized controlled trial groups with increasing intervention intensity: mailed material     and basic Web access (RCT1), plus an interactive Web site (RCT2), plus brief phone- and     Web-based coaching support from health lifestyle coaches (RCT3). The study assessed changes     in participants' weight, blood pressure, diet, and physical activity from baseline to 6, 12,     and 15 to 18 months. Analyses estimated overall cost savings and calculated the     cost-effectiveness ratio of each randomized controlled trial compared with a do-nothing     alternative as the cost per quality-adjusted life year.   "
151005|NCT01307267|"     A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid     tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive     Non-Hodgkin's Lymphoma (NHL).   "
151006|NCT01307254|"     The investigators hypothesize that low iron storages protects from and down-grades     non-alcoholic fatty liver disease.      The aim of the study is to show the association between the severity of Non-alcoholic fatty     liver disease to low iron status.   "
151007|NCT01307241|"     Results of actual treatment in ALL are not optimal. New prognostic factors, which may     determine clinical & molecular response are required. Hyper-CVAD is an internationally     accepted schema for such patients. The objective of this pilot study is to evaluate     polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the     function of these proteins, and therefore the intracellular bioavailability of methotrexate.     Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for     citarabine intracellular transport and activation, respectively. Clinical characteristics     will be tabulated and analyzed for responders & non-responders patients. Uni- & multivariate     analysis will be done to evaluate factors influencing on response and survival.   "
151008|NCT01307228|"     The investigators have developed an online database called 'Health Systems Evidence,' which     contains synthesized research evidence and additional details about this evidence that can     make it easier for health system policymakers to use the included research evidence. The     investigators have also developed an e-mail alerting service that brings to the attention of     health system policymakers any new additions to Health Systems Evidence. This study will     evaluate whether a full-serve version of Health Systems Evidence increases the use of     research evidence by policy analysts and advisors in the Ontario government as compared to a     self-serve version. The full-serve version comprises: 1) access to Health Systems     Evidence; 2) monthly e-mail alerts about new additions to Health Systems Evidence; and 3)     access to full-text articles that are cited in Health Systems Evidence. The self-serve     version only provides access to Health Systems Evidence. The investigators will also     interview study participants to obtain feedback about Health Systems Evidence, including how     helpful it was in their work, why it was helpful (or not helpful), what aspects were most and     least helpful and why, and recommendations for improving it.   "
151034|NCT01306890|"     The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs)     following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.   "
151010|NCT01307202|"     Total knee arthroplasty is amongst the most painful procedures postoperatively, and pain     management can be a challenge. Different measures have been introduced to manage severe     postoperative pain int hese patients. Previous studies have investigated gabapentin in acute     postoperative pain and demonstrated reducted pain, postoperative morphine consumption,     morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct     has yet to be investigated in total joint arthroplasty patients.   "
151011|NCT01307189|"     This study was designed to test the following hypothesis:      A) The acute and long-term (3 weeks) bronchodilator-induced changes in exercise tolerance and     in the physiological response during the endurance shuttle walk will be greater with     tiotropium compared to placebo in COPD patients.      B) Three weeks of bronchodilation will be associated with increase activity of daily living     as evaluated using the London Chest Activity Daily Living scale.   "
151012|NCT01307176|"     The purpose of this study is to determine whether a person's ability to adapt (i.e. short     term motor learning) predicts their ability to benefit from physical therapy exercises.   "
151013|NCT01307163|"     Saliva is used nowadays as a significant diagnostic tool due to the latest technological     developments. The research compares two experimental groups; children after liver     transplantation and a control group.      Our objective is to identify from all the parameters that are evaluated, the ones that differ     between the two groups. If such parameters will be found and differ statistically, it will be     possible to create a non invasive medical examination protocol, which will probably be much     more complaint, and being so would help locate individuals in risk groups with the tendency     to develop an end-organ liver disease.   "
151014|NCT01307150|"     The purpose of this study is to evaluate the improvement in severity of Atopic Dermatitis and     quality of life after 4 weeks of treatment in the Dead Sea.   "
151015|NCT01307137|"     The prevalence of obesity and diabetes in older adults is increasing. Because older adults     are often portrayed as less likely to change long-standing health behaviors, health promotion     in this age group has lagged behind others. In fact, little attention has been given to the     importance of diabetes prevention in community-dwelling older adults through the     implementation of programs that promote healthy nutrition, increase physical activity and     improve self-management. The Diabetes Prevention Program (DPP), which demonstrated the     benefit of modest weight loss on the reduction of diabetes risk (58% overall reduction with a     71% reduction in the older population), has yet to be translated into widespread public     health practice.      The overall objective of this protocol is to implement evidence-informed, innovative     interventions to increase adoption of findings from comparative effectiveness research (CER)     for diabetes management and prevention in South Florida older veterans. Specifically, the     proposed study will test the hypothesis that Peer-led Care alone (PC), or activated by     technology (TechnAlert-Peer or TAP), is superior to traditional methods of information     dissemination (Usual Care or UC) for adoption of CER on prevention and management of     diabetes, leading to better self-efficacy and clinical outcomes.      The investigators will conduct a 12-month randomized controlled trial in older veterans with     prediabetes and diabetes participating in one of the Healthy Aging Regional Collaborative     programs. Primary outcomes include changes in self-efficacy, weight, and hemoglobin A1c.     Secondary outcomes include changes in blood pressure, lipids, physical function, quality of     life, and health care utilization and the evaluation of potential racial/ethnic disparities     in the process of adoption of CER for prevention and management of diabetes.      This study is expected to accelerate the implementation of CER evidence for diabetes     prevention, addressing health and economic challenges in the care of overweight and obese     veterans.   "
151016|NCT01307124|"     To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir     containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48     week   "
151017|NCT01307111|"     The purpose of this study is to see if using misoprostol makes the intrauterine device     insertion easier and less painful in women who have never had a baby.   "
151018|NCT01307098|"     This is the first clinical study of SBC-102 (sebelipase alfa) for the treatment of LAL     Deficiency. It is an open label dose escalation study in adult patients with liver     dysfunction due to Lysosomal Acid Lipase (LAL) Deficiency and will examine three doses of     SBC-102 (sebelipase alfa). The targeted number for this study is 9 evaluable subjects.   "
151019|NCT01307085|"     The purpose of this study is to determine whether ischemic preconditioning reduces lung     injury in patients undergoing pulmonary resection.   "
151020|NCT01307072|"     The relationship between the surgical outcome of vitreous surgery for proliferative diabetic     retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.   "
151021|NCT01307059|"     This is a Swedish, Multicentre, Observational Registry to study Adherence and Long Term     Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via Easypod™.   "
151022|NCT01307046|"     This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension     participants who are not adequately controlled with losartan.   "
151023|NCT01307033|"     This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential     hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).   "
151024|NCT01307020|"     The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol     and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single     component in comparison to placebo on moderate to severe pain following impacted third     mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate     the pain model.   "
151025|NCT01307007|"     The primary objective of this study is to assess the safety of an investigational intravenous     iron (ferric carboxymaltose [FCM]) or an equal dose of iron dextran and explore the mechanism     of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran     when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).   "
151026|NCT01306994|"     The hypotheses of the present study of Freeman-Sheldon syndrome (FSS) and related conditions     are: (1) that exercise capacity is lower in FSS patients versus normal controls, and the     lower exercise capacity is due to changes in the muscles' normal structure and an inability     of sufficient quantity of the energy molecule to bind to muscle; (2) this muscle problem     reduces amount of air that can get in the lung and amount of oxygen carried in the blood,     which then has the effect of increasing heart and respiration rates, blood pressure, and deep     body temperature, and produces muscle rigidity; (3) the events noted above, when they occur     during cardiac stress testing, are related to a problem similar to malignant hyperthermia     (MH) reported in some muscle disorders without use of drugs known to cause MH. MH (a     life-threatening metabolic reaction that classically is triggered when susceptible persons     receive certain drugs used in anaesthesia.   "
194189|NCT00387725|"     Study to evaluate the safety of an investigational meningitis vaccine and the immune response     to it in adolescents   "
151027|NCT01306981|"     This study will evaluate the effect of ranibizumab on patients undergoing vitrectomy surgery     for the complications of diabetic retinopathy.      Vitrectomy surgery can be difficult and bleeding after the operation can reduce vision for     patients. Our hypothesis is that injection into the eye of ranibizumab one week before     surgery will make the surgery easier, reduce complications and improve outcome.      In this trial, patients will be randomly allocated to receive either ranibizumab injection or     a placebo injection of saline. Neither the patient, their surgeon, nor the study     investigators will know which they have received so that a fair comparison can be made.   "
151028|NCT01306968|"     This is a Phase II randomized trial designed to describe the magnitude of change between     baseline and follow-up outcomes for symptom surveys and a battery of neuropsychological tests     administered at time points corresponding before and after 10 weeks over observation in four     groups:        -  A military population with post-concussion syndrome (mTBI) receiving local standard care        -  A military population with post-concussion syndrome (mTBI) receiving local standard care          and sham hyperbaric oxygen sessions        -  A military population with post-concussion syndrome (mTBI) receiving local standard care          and hyperbaric oxygen at 1.5 atmospheres sessions        -  A otherwise similar group with PTSD but no history of TBI receiving local standard care          Differences and variability of the tests will be used for determining the optimum          primary endpoint(s) for future trial, as well as for refinement of sample size and power          calculations for these studies. The groups undergoing hyperbaric sessions will be          assigned to receive HBO2 or sham using a randomized, double blind design.      Active duty military (Army, Marine, Navy, Air Force) men and non-pregnant women residing in     the United States and who will remain in the military for the entire study period, aged 18-65     years who have been deployed one or more times to the US Central Command since the initiation     of Operation Enduring Freedom (October 7, 2001) who either:        -  have been diagnosed with Post Traumatic Stress Disorder (PTSD) as a result of traumatic          events that occurred during the qualifying CENTCOM deployment, but have no diagnosed or          suspected lifetime brain injuries resulting in loss or alteration of consciousness; OR        -  have been diagnosed with at least one mild brain injury (mTBI) with persistent (> 4          months) symptoms sustained during one or more of those deployments   "
151029|NCT01306955|"     The goal of this study is to examine the efficacy of 1gram/day intravenous pulses of     methylprednisolone on 3 consecutive days in Behcet's patients with ocular involvement. A     total of 34 Behcet's patients referring to Behcet's clinic in Shariati hospital whose problem     was confirmed with new international criteria of Behcet's disease (ICBD) will be randomly     assigned into one of the two equal groups of intervention or control. Behcet's patients are     those with ocular involvement who were under the same cytotoxic treatment with     cyclophosphamide and azathioprine. For the patients in the intervention group, intravenous     infusion of 1000 mg methylprednisolone in 100cc D/w 5% or 100cc D/w5% on 3 consecutive days     will be added to treatment diet. Then treatment will begin with oral prednisolone, 0.5 mg/kg.     After that, all the patients were followed up with no other therapeutic intervention by study     group. The patients will be visited every 2 months by an ophthalmologist and study group for     6 months in 3 settings. To estimate the ocular inflammation of patients, we use visual     acuity, retinal and ocular posterior chamber inflammation index.   "
151030|NCT01306942|"     This is a single-arm, open-label, phase I/II study. In the phase I, patients with     HER2-positive MBC will be treated with paclitaxel, trastuzumab and increasing doses of     dasatinib to determine the MTD (Maximum Tolerated Dose), DLT (Dose Limiting Toxicity) and RPD     (Recommended Phase II Dose) of the combination. Once the RPD has been identified, 48     additional patients will be treated at that dose to evaluate the efficacy and safety of the     combination in the phase II.      Primary Objective:        -  To determine the maximum tolerated dose (MTD) and recommended phase II dose (RPD) of          dasatinib in combination with fixed doses of trastuzumab and paclitaxel in HER2-positive          MBC patients (Phase I).        -  To determine the efficacy, measured by objective response rate (ORR) in HER2-positive          MBC patients with measurable disease (Phase II).      Primary Endpoint:        -  To determine the incidence rate of dose limiting toxicity (DLT) within the first cycle          of dasatinib in combination with trastuzumab and paclitaxel at each dose level in          HER2-positive MBC patients (Phase I).        -  To assess the ORR (defined in the RECIST 1.1 as complete response rate + partial          response rate) measured by the appropriate radiological test in HER2-positive MBC          patients with measurable disease (Phase II).      Sample Size:      Phase I: following the 3+3 rule, a minimum of 6 and a maximum of 12 patients will be     recruited.      Phase II:Assuming 10% drop-out rate, 48 patients are required to enter the study.      The duration of the study, from first patient visit to last patient visit will be     approximately 42 months.   "
151031|NCT01306929|"     Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in     movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized     by chorea (involuntary movements) and a progressive loss of voluntary movement causing a     substantial functional impairment over time. The study will assess the long-term safety of     pridopidine and the treatment effects during long-term, open-label treatment.   "
151032|NCT01306916|"     Purpose: Prospective studies of patients with hyperparathyroidism are warranted to determine     the prevalence of concurrent thyroid disease applying the current standard of pre-operative     radioscintigraphic and sonographic imaging of the neck. Timely diagnosis and treatment of     co-existing thyroid disease is advantageous given the well-established increased morbidity     associated with a second neck exploration. The purpose of this study is to determine the     prevalence and specific type of thyroid disease in patients with hyperparathyroidism, and to     determine the frequency with which the presence of thyroid disease alters the treatment plan     for patients with hyperparathyroidism.      Research Design: This will be a prospective single arm observational study of up to 200     military health care beneficiaries over the age of 18 years with primary and secondary     hyperparathyroidism scheduled to undergo parathyroid resection.      Methodology: Patients will undergo standard pre-operative imaging of the neck including     ultrasonography and 99mTc-sestamibi scintigraphy. An operative plan will be developed based     on the information obtained from history, physical examination, laboratory studies, and     imaging studies. The number and type of thyroid disease in these patients will be determined     based on these non-invasive studies (Objective A). A change in the otherwise standard     treatment will include those patients having partial or complete resections of their thyroid     glands because: a) the patients would have undergone minimally invasive surgery if not for     the results of the imaging studies, and, b) the patients who would have undergone 3 ½ gland     parathyroidectomy if not for the results of the imaging studies (Objective B).   "
151035|NCT01306877|"     The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse     Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based     on the primary endpoint.   "
151796|NCT01296867|"     To study the postoperative results in myopic and hyperopic eyes treated with two different     laser ablation algorithms (STD and F-CAT), both FDA approved.   "
151037|NCT01306851|"     The anastomotic leak is one of the most feared complications in abdominal surgery. Certain     control methods have been described but the incidence of that complication remains high and     is the first cause of mortality in operations where gut anastomosis are performed.      With the aim to prove that the use of fibrin glue in the gut anastomosis can improve gut     cicatrization, the investigators started the recruitment of patients to that clinical trial     in 2007 with the study hypothesis that patients with a gut anastomosis where fibrin glue was     used, had less anastomotic leaks than that where the fibrin glue was not used.      The investigators have calculated the number of patients necessaries to have statistical     significant differences in 200 patients with a rate anastomotic leak expected to be higher     than 10%.      The study include all the patients that usually arrive to our surgery department and that are     expected to have a high risk gut anastomosis: rectal anastomosis, GI anastomosis in the obese     patient, small bowel anastomosis in the obstructed one and esophageal anastomosis.      The study is randomized, simple blind where the patient does not know if they are in the     fibrin glue group or not, and prospectively analyzed. All the clinical and laboratory or     radiographic finds relative to the occurrence of an anastomotic leak are recorded.   "
151038|NCT01306838|"     Necrotizing enterocolitis (NEC) and intestinal perforation are common in premature infants.     Often surgery is needed to remove the dead bowel and create an ostomy (a temporary intestinal     opening on the infant's abdomen). Infants with ostomies cannot digest and absorb food well,     and must receive nutrition through the blood stream, i.e. parental nutrition (PN). However,     prolonged dependence on PN can severely damage the liver and gut. Therefore, giving nutrition     through the gut, i.e. enteral nutrition, is the primary treatment for infants with ostomies.      Enteral fats, especially polyunsaturated fatty acids (PUFA), are most beneficial in     stimulating gut mucosal adaptation, which begins 24 to 48 hours following bowel resection. In     addition, the premature intestine has a rapid growth rate. It is likely that the current     clinical practice of giving a relatively low-fat diet to infants with ostomies may not meet     their high metabolic needs.      The investigators hypothesize that increasing dietary fat content by early supplementation     with MicroLipid® (ML, n-6 PUFA) and fish oil (FO, n-3 PUFA) to preserve the proper balance of     n-6 and n-3 PUFA, may (i) improve bowel adaptation and infant growth; (ii) reduce the use of     PN; and (iii) prevent liver damage and/or cholestasis (jaundice) in infants with ostomies.   "
151039|NCT01306825|"     Bone and joint infections are commonly due to Gram-positive bacteria. Treatment of these     infections is difficult because of the need of prolonged duration of antimicrobial agents in     combination with surgical procedure. Moreover, in recent years, a growing resistance pattern     to various antimicrobial agents has been observed for Gram-positive bacteria. Consequently,     there is an urgent need for new drugs with high bone penetration for the treatment of those     infections. The investigators hypothesized that daptomycin allow to achieve high     concentrations in bone compartments.   "
151040|NCT01306812|"     The interaction of MAO-A genotype and psychosocial risk, in relation to male adolescent     criminality The interaction of 5-HTTLPR genotype and psychosocial risk in relation to     excessive adolescent alcohol consumption The interaction of 5-HTTLPR genotype and     psychosocial risk in relation to depressive symptoms among adolescents The interaction of     MAO-A genotype and psychosocial risk, in relation to female adolescent criminality   "
151041|NCT01306799|"     Patients with severe acid reflux and/or Barrett's esophagus are recommended to take Proton     pump inhibitors (PPIs)indefinitely to prevent complications such as strictures or the     development of a type of esophageal cancer. Recently, some studies suggested that taking     these medications on a long-term basis may affect the bone. Therefore, it is important to     learn whether these medications may lead to accelerated bone loss so that effective     preventive measures can be developed for patients who require these medications for     acid-related conditions. Several studies reported that patients receiving PPIs for many years     may have increased risk of hip fractures. However, it is unclear whether this is because the     PPIs cause reduced bone density or whether the increased risk of fractures has nothing to do     with PPIs and is because patients who require PPIs have other illnesses that cause the     increased fractures. The purpose of the study is to learn how bone structure and bone mass     change after long-term PPI use.   "
151042|NCT01306786|"     The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori     eradication with a 5-day quadruple therapy versus a clarithromycin-containing triple therapy.   "
151043|NCT01306773|"     Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.   "
151044|NCT01306760|"     The main aim of this research is to ascertain whether Ketamine would be a more effective     anaesthetic for Electroconvulsive Therapy (ECT) than the standard anaesthetic. In doing so     the investigators aim to examine the effect of ketamine on ratings of depressive symptoms,     the number of required ECT treatments, and the effect of this anaesthetic on memory.   "
151045|NCT01306747|"     The effect of the Stanford Chronic Pain Self-Management Programme (CPSMP) is tested in a     randomized controlled trial with enrollment of Danish chronic pain patients. A total of 500     chronic pain patients is randomized into either an CPSMP intervention group or a control     group.      The CPSMP is brief patient education program consisting of 6 weekly sessions. Two trained     instructors teach a group of 8-16 chronic pain patients about managing pain. The instructors     are not health professionals but chronic pain patient themselves. The program is highly     structured and manualized.      Previous studies have shown beneficial effects of the CPSMP on pain, self-efficacy and     well-being. Hence we expect the CPSMP to have an effect on various domains.        1. Symptom reduction - lower self-reported pain in the CPSMP group compared to controls        2. Illness perception - the cpsmp group will differ from controls in illness perception and          have higher disease related self-efficacy        3. Sickness behavior - the cpsmp group will have fewer sick days and lower health care          utilization (estimated by registerbased data)than controls        4. Quality of life - the cpsmp group will report higher life satisfaction and less social          isolation than controls   "
151170|NCT01305122|"     This is a multicenter prospective study:2 independant cohorts of patients with OMS grade II     glioma will be followed during 5 years.        -  cohort A: patients in first-line treatment (surgery, radiotherapy or chemotherapy)        -  cohort B: patients with disease simple monitoring.      The primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive     functions and quality of life, using validate and standard tests.   "
151046|NCT01306734|"     PURPOSE: To compare crash cooling versus gradient cooling methods for patients undergoing     planned surgery on the ascending aorta in deep hypothermic circulatory arrest. To investigate     the impact of hypothermia and circulatory arrest on the coagulation, stress-response, and     cerebral outcome.      BACKGROUND: Cooling to 18 °C using extracorporeal circulation allows for circulatory arrest     during surgery on the ascending aorta. Two different methods are used either lowering the     temperature of the blood by 10 °C at a time, gradient cooling, or as cold as possible, crash     cooling. The distribution of hypothermia is expected to be different for the two methods, the     latter predominantly cooling the body core. The influence on the physiological response is     expected to vary with the two methods. The surgical procedure and the cooling greatly elicit     a stress response and the coagulation is profoundly influenced. There can be adverse effects     on the neurological outcome due to the procedure. The two methods are considered equal, but     have never been subjected to comparison. The surgery and circulatory changes can have a     negative influence on the cerebral outcome .      METHODS: Twenty patients between 18 and 80 yrs randomized either to crash cooling or gradient     cooling, ten patients in each group.. Patients with severe comorbidities or known     coagulopathy are excluded. Anesthesia and operation as performed routinely in the department.     The primary endpoint is duration of cooling, secondary endpoints include coagulation     parameters (thromboelastography, clot stability), stress response parameters (adhesion     molecule expression on endothelial cells, oxidative stress analysis, inflammatory markers),     neuropsychological tests, MRI of the cerebrum, markers of cerebral ischemia, and ultrasound     imaging of the great vessels for detection of air bubbles. Baseline values are obtained for     all parameters.   "
151047|NCT01306721|"     Primary Objective:      - To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg -     pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg -     pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60)     in patients with seasonal allergic rhinitis (SAR).      Secondary Objectives:        -  To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on          nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily          activity impairment.        -  To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.   "
151048|NCT01306708|"     The adhesive capsulitis is a disease of the shoulder characterized by pain and limitation of     movement amplitude. It is defined as for etiology, having discordant theories that related it     to an inflammatory condition or to an algoneurodystrophy process. There is not yet a     consensus about the best option of treatment. The non-steroidal anti-inflammatories have     analgesic and anti-inflammatory activity, where the mechanism of action is the inhibition of     prostaglandin synthesis. The antidepressants have been increasingly used in the control of     chronic pain and the major action mechanism to have the analgesic effect seems to be based on     inhibition of neurotransmitters reuptake noradrenaline and/or serotonin) in nerve cell     endings. Literature studies associate the practice of the nerve suprascapular blockade with     anaesthetics to good results of clinical improvement of the pain, however, so far, no     clinical studies comparing the efficacy of the non-steroidal antiinflammatories or tricyclic     antidepressants to nervous blockage were registered in the acute treatment of adhesive     capsulitis.   "
151049|NCT01306695|"     Elderly Hispanics have a higher burden of dementia compared to Non-Hispanic Whites.     Furthermore, Hispanic caregivers tend to have a higher burden of care for their relatives     with dementia. The objective of this project is to conduct a randomized trial in 160 Hispanic     relative caregivers of persons with dementia comparing the effectiveness of New York     University Caregiver Intervention to a case management intervention lead by community health     workers(CHW). This trial will last 6 months. The main outcomes in the trial will be changes     in depressive symptoms measured with the Geriatric Depression Scale and caregiver burden     measured with the Zarit Caregiver Burden Scale. This research project will be conducted by     the Northern Manhattan Center of Excellence in Comparative Effectiveness Research for     Eliminating Disparities (NOCERED) funded by the National Institute on Minority Health and     Health Disparities.   "
151050|NCT01306682|"     This randomized, placebo controlled trial will evaluate the safety and immunogenicity of     Trivalent Influenza Vaccine (TIV) in HIV-infected pregnant women, dynamics of transplacental     anti-influenza antibody transfer to their newborns and kinetics thereof during early infancy.   "
151051|NCT01306669|"     Randomised, double blind, placebo controlled trial to assess safety, immunogenicity and     efficacy of Trivalent Influenza vaccine in HIV uninfected pregnant women   "
151052|NCT01306656|"     This study will look at the effect of 2 treatment regimens that contain vitamin D in a     six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will be     assigned randomly to one of 2 regimens, and will be followed with tests of their blood, urine     and bones. This study should provide important information on the effect of vitamin D therapy     in patients with PHPT. In addition, data from this study will guide physicians as to how best     to treat their patients who have PHPT and vitamin D deficiency.   "
151053|NCT01306643|"     The primary objectives of this study is to evaluate the safety and efficacy of idelalisib     (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma     (iNHL).      Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg     twice per day. Treatment with idelalisib can continue in compliant participants for up to     twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment     at the completion of 12 cycles of treatment with idelalisib may be eligible for participation     in a long-term safety extension study of idelalisib.   "
151054|NCT01306630|"     This is an open-label, multi-center, dose-finding study of tivozanib administered in     combination with capecitabine. During the dose-escalation portion, sequential cohorts of     subjects with advanced solid tumors will be enrolled in order to establish the maximum     tolerated dose (MTD). If the MTD is not reached, the recommended Phase 2 dose (RP2D) will be     determined. In the expansion cohort, subjects with locally advanced or metastatic breast or     colon cancer will be enrolled at MTD (or RP2D) to further evaluate safety and activity of     this combination in these tumor types.   "
151055|NCT01306617|"     The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics     of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as     dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with     genotype 1 chronic hepatitis C virus (HCV) infection.   "
151169|NCT01305135|"     Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the     FDA/EMEA approved Schedule and dosing.      For the Phase I study :      Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine     in patients with INT-2 or higher risk MDS.      For the phase II study:      Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000     criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher     risk MDS   "
151056|NCT01306604|"     Niemann Pick Syndrome Type C is a lysosomal storage disorder, caused by a pathological     overload of cells with unesterified cholesterol as a result of impaired lipid transport into     the cell, has still the problem of the difficulties of a simple and reliable analysis for the     primary diagnosis but also for the follow-up of the disease. Therefore the primary aim of our     project called BioNPC is the development of a new plasma biomarker for the early and     sensitive diagnosis of the disease. The secondary aim is the testing for clinical robustness,     specificity and long-term stability of the biomarker.      Within the scope of the study the investigators would like to collect in the next 12 months     from about 80 patient's plasma and parallel a simple documentation of the clinical data.   "
151057|NCT01306591|"     Age-related macular degeneration (AMD) is one of primary blinding eye disease among people     over 65 years in China. The anti-VEGF antibody treatment is proved useful for Neovascular     Age-related Macular Degeneration (nAMD) by many studies. Bevacizumab is the only available     low-cost type of anti-VEGF drug currently in China. This study is a multi-center, randomized     trial of Bevacizumab effective dose and safety for nAMD. This study is to explore the     effective therapeutic approach that the majority of patients in China can bear establishing a     suitable treatment for China.   "
151058|NCT01306578|"     Comparing whether intravenous immune globulin or plasma exchange is superior in treating     mechanically ventilated children with Guillain Barre syndrome.   "
151059|NCT01306565|"     The aim of this study is to compare the effect of high dose and low dose of Atorvastatin in     reduction level of C-reactive protein (CRP) in patients with unstable angina and NSTEMI (Non     ST Elevation MI) attending Shahid Mohammadi hospital in Bandar Abbas.   "
151060|NCT01306552|"     The purpose of this study is to evaluate the effectiveness of a combined parent-student     program for smoking prevention in 7th graders in Berlin schools.   "
151061|NCT01306539|"     Stimulation of the subthalamic nucleus will have effects on various aspects of     neuropsychiatric function.   "
151062|NCT01306526|"     Obstructive sleep apnea (OSA) is a respiratory disorder of sleep characterized by recurrent     episodes of complete or partial upper airway obstruction, leading to intermittent oxygen     deprivation. This results in sympathetic activation and surges in blood pressure, production     of vasoactive substances, as well as activation of the inflammatory and procoagulant     pathways. Epidemiological evidence indicates the prevalence of OSA is higher in patients with     coronary artery disease than in the general population. The investigators recently showed     that 65.7% and 41.9% of the Singapore patients admitted with myocardial infarction were found     to have previously undiagnosed OSA and severe OSA, respectively. In a 10-year follow-up     epidemiological study, OSA was independently associated with a higher prevalence of fatal and     non-fatal cardiovascular events among the otherwise healthy general population. The     investigators further showed that in patients who have undergone primary percutaneous     coronary intervention for acute myocardial infarction, OSA was an independent predictor of     future adverse event rates. Despite the observed association between OSA and adverse     cardiovascular outcomes, the underlying pathophysiological mechanisms remain unclear. In this     proposal, the investigators aim to elucidate the relationship between OSA and composition of     coronary atherosclerotic plaques.   "
151063|NCT01306513|"     The purpose of this study is to show safety and feasibility to administer patients own     mesenchymal stem cells to show signs of repair of emphysematous lung tissue   "
151064|NCT01306500|"     The purpose of the study is to evaluate the role of gastric lavage in preventing feeding     problems in babies born through meconium stained amniotic fluid. It is a routine practice in     many hospitals to perform gastric lavage in all babies born with meconium stained amniotic     fluid after stabilisation without any supporting evidence. It is believed that meconium is an     irritant and its presence in stomach causes gastritis and vomiting and hence the basis for     this practice. Orogastric tube insertion and subsequent gastric lavage is not without     complications. Potential complications will be prevented and health resources will be saved     if this procedure is not proven to be beneficial. Therefore the investigators decided to     study if gastric lavage reduces incidence of vomiting and other feeding difficulties as well     as incidence of respiratory difficulties in babies born with MSAF.   "
151065|NCT01306487|"     The objective is to determine whether a recovery of the microstructures of the foveal     photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual     acuity (BCVA) is determined.   "
151066|NCT01306474|"     AIM: To study the expression of CD4+CD25+ high regulatory T cells in peripheral blood of     patients with uveitis and to explore its role in the development of uveitis.   "
151067|NCT01306461|"     The purpose of this study is to compare the efficacy and safety of the preservative-free     fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of     tafluprost and timolol.      This study will enroll patients who have ocular hypertension or glaucoma.      The study schedule includes seven visits to the study site and three stages:        -  washout of 5 days to 4 weeks depending on current glaucoma medication (if any)        -  6-month study treatment period        -  1-3 weeks post-study period   "
151068|NCT01306448|"     The study will assess the safety of the vibrating capsule in healthy volunteers first and     than for constipation relief constipated individuals.   "
151069|NCT01306435|"     Indroduction: Knee osteoarthritis (OA) is a painful condition causing disability, weakness     and poor quality of live. The results are very consistent about the benefits of laser and     exercises to improve pain and function in subjects with knee osteoarthritis Objectives: To     investigate the effects of Low Power Laser (LBP) associated with exercise in pain, function,     range of motion, muscle strength and quality of life of patients with knee osteoarthritis.      Methods: Forty patients of both sexes aged between 50 and 75 years with knee osteoarthritis     (grade 2-4) were randomized into two groups: Laser-LBP-active dose of 3J more exercises and     Group Placebo-LBP- placebo and exercise. Were evaluated for pain, function, range of motion,     muscle strength and quality of life on three occasions: before starting treatment (evaluation     1), 3 weeks after laser application (evaluation 2) and 8 weeks after completion of exercise     (evaluation 3). There were 33 physical therapy sessions three times a week, on March 1 and     the laser was applied in the other, only the exercises.   "
151070|NCT01306422|"     The objective of this clinical study was to assess the safety, tolerability, efficacy     (effects on appetite scores, food intake) and plasma kinetics of Hoodia gordonii purified     extract (H.g.PE), when consumed twice-daily for 2 or 15-days.   "
151073|NCT01306383|"     SODISWATER was a health impact assessment study investigating the effect of sunlight to     inactivate microbial pathogens in drinking water. This study was carried out by observing     whether children younger than 5 years old who drink solar disinfected water were healthier     than those who did not. Health was measured by how often the children had diarrhoea or     dysentery.      Caregivers for the participants were given plastic bottles to place in the sun, water samples     were then collected from these plastic bottles to be analyzed. They were also requested to     fill in diarrhea diaries.      TESTABLE RESEARCH HYPOTHESES:      Health Impact Assessment: Children who use solar disinfected water will have:      (a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth     rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden     (g) increased school attendance   "
151074|NCT01306370|"     Objectives:      a) Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the     blood losses with respect to the habitual haemostasia in patients with arthroplasty total of     knee.      Secondaries: To assess the treatment safety. To perform a cost- analyses.      Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups:     Tissucol® (fibrin glue), fibrin glue manufactured by the Cryoseal® system (Banc de Sang i     Teixits de Catalunya), tranexamic acid and habitual haemostasia.      Nº of participant centres: 1. Random allocation will be centralised.      Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain     system.      Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery     wound, pre and post-operative haemoglobin, units of blood transfused, post-operative     mortality, days of hospital stay, safety of interventions assessed.      Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate a     20% difference in the post-operative blood losses between the treatments assessed and the     habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20%     of withdrawals.      Statistical analysis: The investigators will perform a comparison of outcomes through the t     test, the Mann-Whitney test of chi square, depending of the evaluated outcomes, quantitative     or ordinals or qualitative, respectively. The software used will be Statistical Package for     the Social Sciences (SPSS) version 17.   "
151075|NCT01306357|"     The purpose of this strictly observational, prospective, longitudinal study is to evaluate     with sufficient precision the rate of overall treatment compliance from one year to 3 years     of follow-up of the patients.      Somatotropin is indicated in the long-term treatment of children with growth retardation     related to a deficiency in secretion of growth hormone and in the long-term treatment of     growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are     the two indications of Zomacton® 4 mg and 10 mg injection solution.      The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the     administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for     the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous     transjection (needle-free) and can be used by the child directly or by the family after an     initial training.      In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a     follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the     compliance and duration of use of the device.      The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device     is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90     patients will be treated. In the cohort studied the patients will be followed-up for 1 year     at least and for 3 years at the maximum.      The rate of treatment compliance will be evaluated according to the ratio of the actual     duration of administration over the total duration recommended by the physician during the     observation period.   "
151076|NCT01306344|"     1. A qualitative descriptive design.        2. A phenomenologic approach to investigate the meaning of the ward round.        3. Interviews of patients, nurses and physicians.        4. A Master thesis.   "
151077|NCT01306331|"     This is a research study of a new experimental vaginal gel known as a spermicide, a birth     control method that kills sperm. This spermicide, called Amphora™, is being compared to a     commercially available spermicide called Conceptrol®, which contains nonoxynol 9; commonly     abbreviated as N-9. Conceptrol® can help prevent pregnancy. This study will determine if this     product prevents pregnancy when inserted into the vagina before intercourse.   "
151078|NCT01306318|"     The primary objective of this study is to compare the bioavailabilities of a single fixed     dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the bioavailabilities     of eperisone 50 mg tablets and diclofenac 50 mg tablets in healthy human adult male subjects     under fasting conditions.   "
151079|NCT01306305|"     A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal     V fulfills the EMEA requirements for re-registration of influenza vaccines   "
151080|NCT01306292|"     This is an intra-subject crossover comparative safety study to evaluate the effect of     intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.   "
151081|NCT01306279|"     Given the treatment burden and excess morbidity and mortality associated with acute infective     exacerbations in cystic fibrosis, a clear understanding of the mechanisms involved in the     origins of an infective exacerbation and the response to antibiotics is vital to improving     long-term outcomes in CF.      This study will examine 3 areas of interest in CF exacerbations.        1. Bacterial biodiversity and its clinical significance        2. The role of bacteria which are able to rapidly mutate (hypermutators)        3. Inter-bacterial communication and its role in infective exacerbations      Study Hypothesis 1      Increased microbiological diversity represents a balanced community of bacteria. The presence     of a diverse population of bacteria in CF infections therefore predicts a better outcome for     treatment than when a population consists of a small number of more virulent organisms.      Study Hypothesis 2      Pseudomonas aeruginosa hypermutators can mutate much more often than ordinary Pseudomonas     aeruginosa bacteria. Hypermutators are likely to grow better when the bacteria are under     stress, such as during antibiotic treatment or during an infection. They are, however, weaker     organisms because of the multiple mutations they have undergone. Their presence does not     relate to clinical outcome but may be associated with the emergence of antibiotic resistance.      Study Hypothesis 3      Some Pseudomonas aeruginosa bacteria communicate with each other by secreting and responding     to chemicals known as quorum sensing (QS)molecules. As well as affecting the behaviour of     bacteria, these QS molecules can cause inflammation in the lung of CF patients. Selective     growth of QS-producing organisms can trigger lung exacerbations in CF. If antibiotics kill     this population of bacteria and QS molecule levels drop in the lung, patients recover from     infection quickly. Failure to kill these bacteria with antibiotics allow QS molecule levels     to remain elevated and patients to have prolonged infections.   "
151082|NCT01306266|"     The purpose of the study is to determine the effectiveness of rizatriptan for treating     attacks of chronic post-traumatic headache.   "
151083|NCT01306253|"     This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine     Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines.   "
151084|NCT01306240|"     Term and near term newborns can present acute respiratory distress syndrome (RDS). Surfactant     treatment has been shown effective in reducing mechanical ventilation and oxygen treatment     durations in the preterm newborn. Whether surfactant treatment is beneficial for term and     near term newborns is unknown. The purpose of this study is to compare surfactant treatment     vs. nasal continuous positive airways pressure in the newborn between 35 and 41 weeks of     gestation with RDS within the first 24 hours of life. The study's primary endpoint is     survival with no oxygen treatment at 72 hours of life. The secondary endpoints are: death,     surfactant treatment, pneumothorax, secondary infections, pulmonary hypertension, inhaled     nitric oxide treatment, fluid loading treatment, vasopressive amines treatment, mechanical     ventilation duration, nCPAP treatment duration, Oxygen treatment duration, Oxygen treatment     at 28 days of life, hospitalization duration and treatment strategy cost.   "
151085|NCT01306227|"     Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental     impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether     L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial.      The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less     than 32 WG with THOP.      The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the     Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen     therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus, shock     requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular hemorrhage,     retinopathy of prematurity, deafness.   "
151086|NCT01306214|"     This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin     in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of     insulin in this population would provide significant new information for the BI 10773 use and     would offer a potential new therapeutic option in this population.   "
151087|NCT01306201|"     Data collected from this study will be used to evaluate the performance of a monitoring     algorithm.   "
151088|NCT01306188|"     The T and B cells repertoire diversity represent one of the immune defence level which     controls the integrity of the organism and determines its ability to recognize and control     infectious attacks and development of tumours. The study of the lymphocytes TCR and BCR     diversity could permit to better understand how lymphopenia act on overall survival and to     improve detection of high risk patients who could benefit of adapted therapies for better     care.   "
151089|NCT01306175|"     The objective of the study is to investigate the relative bioavailability of digoxin after     concomitant multiple oral administration of BI 10773 and a single dose of digoxin in     comparison to digoxin given alone to healthy male and female subjects.   "
151090|NCT01306162|"     The objective of the study is to assess the relative bioavailability of a single dose of     dabigatran after concomitant multiple oral administration of dronedarone with the aim to     investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic     parameters of dabigatran when administered to healthy subjects   "
151091|NCT01306149|"     The aims of this study are        1. To evaluate the natural history of plasma concentrations and renal and peritoneal          clearances of small water-soluble uremic retention molecules (URM), 'middle molecules',          and protein bound URM in incident peritoneal dialysis (PD) patients.        2. To evaluate the natural history and determinants of the generation rate of URM          originating from bacterial protein fermentation in PD patients.        3. To evaluate the natural history of biochemical parameters of mineral metabolism in          incident PD patients.   "
151092|NCT01306136|"     The purpose of this project is to examine the feasibility of a culturally adapted, manual     based Prolonged Exposure therapy intervention for the treatment of Spanish-speaking Puerto     Ricans with posttraumatic stress disorder   "
151093|NCT01306123|"     The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal     Spray as compared to an IM injection of cyanocobalamin (European reference product).   "
151094|NCT01306110|"     The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers     in patients with diabetes.   "
151095|NCT01306097|"     Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and     recurrent diarrhea in 6 to 36 months age children in Bandarabbaas   "
151096|NCT01306084|"     Background:      - Viral infections are an important cause of illness and death in hospitalized patients as     well as outpatients. New strains of viruses may appear and infect both healthy people and     those with weak immune systems. A better understanding of these new virus strains may help to     control and prevent these infections. In particular, some viral infections that are less     problematic in healthy persons can be life threatening in persons with weak immune systems,     and viruses may be able to evolve more rapidly in persons with weak immune systems and     therefore develop resistance to existing treatments. Researchers are interested in collecting     samples and information from otherwise healthy persons or persons with weak immune systems to     study the effects of viruses and their development.      Objectives:      - To collect samples and data from individuals who have been exposed to or have contracted     viral infections.      Eligibility:        -  Individuals of all ages who have been diagnosed with a viral infection are suspected to          have a viral infection, or have been in close contact with someone with a suspected or          actual viral infection that is of interest to investigators in the Laboratory of          Infectious Diseases.        -  Healthy persons and persons with weak immune systems (immunocompromised individuals) are          eligible to participate.      Design:        -  Participants will be initially screened with a review of the medical records and if          eligible a history and physical will be performed.        -  Study procedures may include blood, stool, urine, saliva, or nasal fluid samples, and          throat and genital swabs. For participants who have a specialized sample collection          procedure as part of their medical care (e.g., spinal tap, bronchoscopy, liver biopsy),          researchers may collect leftover samples from the clinical laboratory for testing.        -  Samples may be collected up to four times per week during the first 2 weeks after          enrollment in the study, and then as many as two times per week for up to 1 year. The          number of study visits will be determined by the study researchers, and will depend on          the virus being studied. Some participants may be asked to continue providing samples          for longer than 1 year if there is concern for recurrence or relapse of the infection or          if the study researchers feel that there are other reasons where it would be important          to follow the viral infection.        -  For otherwise healthy persons who have been exposed to a viral infection, an initial          specimen will be collected and then up to three additional specimens may be collected          over 1 year.        -  Treatment will not be offered under this study....   "
151152|NCT01305356|"     STUDY OBJECTIVES:      To demonstrate equivalent clinical and radiologic outcomes as gold standard (Autologous     Bone Graft) in a representative clinical model (hindfoot fusions)      STUDY HYPOTHESIS:      Augment™ Injectable is an equivalent bone grafting substitute to autologous bone graft in     applications as shown by superiority analysis for safety and non-inferiority analysis for     effectiveness      STUDY RATIONALE:      To evaluate a fully synthetic bone graft material to facilitate fusion in conditions or     injuries requiring bone graft in a representative clinical fusion model and thus the     opportunity to provide equivalent union rates as Autologous Bone Graft without necessitating     an additional invasive procedure to harvest the graft   "
151097|NCT01306071|"     Background:      - Chronic hepatitis B virus infection is a leading cause of morbidity and mortality from end     stage liver disease and liver cancer. Although significant progress has been made recently in     hepatitis B therapy, current knowledge about how to manage the infection is limited because     most treatment trials involve 1 to 2 years of therapy at most, even though most patients     require treatment of much longer duration for optimal long-term outcome. To improve current     knowledge on the disease and long-term disease progression, the Hepatitis B Research Network     is collecting health and disease information from individuals who have been diagnosed with     hepatitis B.      Objectives:      - To study individuals with hepatitis B and identify factors that affect the way the disease     progresses.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with hepatitis B.      Design:        -  Participants will be screened with a physical examination and medical history. Health          information will be collected through questionnaires and surveys on health behaviors,          and family history of liver disease. Participants will also provide blood samples, and          those who have had a liver biopsy within the past 2 years or have one during the course          of the study will provide biopsy material for further study.        -  Information will be collected during a series of study visits. Each visit will take          approximately 1 hour. During the first year, participants will have study visits 12          weeks, 24 weeks, and 48 weeks after entering the study. In subsequent years,          participants will have a study visit approximately every 24 weeks (6 months) until the          end of the study.        -  Additional visits will be required of women who are pregnant when enrolled in the study          or become pregnant during the course of the study.        -  Participants whose hepatitis B status changes during the course of the study (for          example, a flare of disease activity) may be asked to return for more frequent visits.   "
151098|NCT01306058|"     Background:      Sorafenib is a drug that has been approved to treat kidney and liver cancer (hepatocellular     carcinoma, or HCC) and has been shown to prolong survival in patients with HCC. It works by     slowing the spread of cancer cells, but it does not fully prevent the cancer from growing     again. Researchers are interested in combining sorafenib with the experimental drug TRC105,     which has been designed to block the growth of blood vessels that lead to tumor growth, in     order to determine whether this drug combination stops tumor growth and reduces tumor size     better than sorafenib alone.      Objectives:      To determine the safety and effectiveness of the combination of sorafenib and TRC105 as a     treatment for hepatocellular cancer that has not responded to other treatments.      Eligibility:      Individuals at least 18 years of age who have been diagnosed with hepatocellular cancer that     has not responded to other treatments, and who are not considered to be candidates for liver     transplantation. Patients cannot be receiving anticoagulant therapy with the exception of low     dose aspirin. No history of bleeding problems or peptic ulcer disease.      Design:      Participants will be screened with a full medical history and physical examination, blood and     urine tests, and tumor imaging studies. Participants will have a tumor biopsy or provide     previously collected tumor tissue for study. An examination of the esophagus to look for     problems with blood vessels will be completed in patients with a history of cirrhosis.      Participants will receive sorafenib tablets twice every day, in the morning and at night,     with a full glass of water.      Participants will receive TRC 105 infusions once every two weeks on days 1 and 15 of a 28 day     cycle.      At each visit during the first cycle, participants will have a physical examination and blood     tests. Participants will continue to have blood tests and a urine test every cycle to monitor     the effects of treatment, including tests of kidney function. Participants will have imaging     studies after every two cycles to evaluate the results of treatment, and may also provide     tumor samples for study.      Treatment will continue as long as the tumor does not grow and side effects remain tolerable.   "
151099|NCT01306045|"     Background:      - The current standard of care for advanced lung cancer and cancers of the thymus consists     primarily of chemotherapy treatment. The drugs used for chemotherapy depend on the     classification of the cancer in different categories that are based on the appearance of the     cancer in the microscope. Though this approach has been proved to be useful in some ways, the     survival rates of individuals with lung cancer and cancers of the thymus are still very poor.     Recent research has shown that several genetic abnormalities play an important role in the     development and growth of lung cancer and cancers of the thymus, and that it is possible to     improve treatment success rates with drugs that specifically target some of the abnormal     genes. Researchers are interested in determining whether it is possible to analyze the genes     of patients with lung cancer and cancers of the thymus in order to provide personalized     treatment with drugs that target the specific gene abnormalities.      Objectives:      - To evaluate the effectiveness of genetic analysis in determining targeted therapy for     individuals with advanced non-small cell lung cancer, small cell lung cancer, and thymic     cancer.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with either lung cancer or a     cancer of the thymus that is not considered to be curable with the use of surgery or     radiation therapy.      Design:        -  Participants will be screened with a full medical history and physical examination,          blood and urine tests, and tumor imaging studies. Participants will have a tumor biopsy          or provide previously collected tumor tissue for study.        -  Based on the results of the tumor biopsy study, participants will be separated into          different treatment groups:        -  Participants with EGFR gene mutation will receive a drug called erlotinib, which          inhibits a protein called EGFR that is thought to be a key factor in the development and          progression of some cancers.        -  Participants with KRAS, BRAF, HRAS, or NRAF gene mutations will receive a drug called          AZD6244, which inhibits a protein called MEK that is thought to be a key factor in the          development and progression of some cancers.        -  Participants with PIK3CA, AKT, or PTEN gene mutations will receive a drug called          MK-2206, which inhibits a protein called AKT that is thought to be a key factor in the          development and progression of some cancers.        -  Participants with KIT or PDGFRA gene mutations will receive a drug called sunitinib,          which inhibits some proteins that are thought to be key factors in the development and          progression of some cancers, including kidney cancer.        -  Participants who have ERBB2 gene mutation or amplification will receive a drug called          lapatinib, which inhibits some proteins that are thought to be key factors in the          development and progression of some cancers, including breast cancer.        -  Participants who do not have any of the genetic abnormalities described above will be          offered different options for treatment, including standard of care chemotherapy or          treatment with investigational agents in a different research protocol.        -  After 6 weeks of treatment, participants will have imaging studies to evaluate the          status of their cancer. Treatment will continue as long as participants tolerate the          drugs and the disease does not progress.        -  Participants who benefit from the first treatment but eventually develop resistance and          progression of their cancer will be offered the chance to have a second tumor biopsy and          undergo a different treatment for their cancer.   "
151100|NCT01306032|"     Background:      - The experimental cancer treatment drug ABT-888 (Veliparib) works by preventing     deoxyribonucleic acid (DNA) repair in tumor cells. Cyclophosphamide is a cancer treatment     drug that works by causing DNA damage in cells, including cancer cells, resulting in cell     death. However, because cyclophosphamide has strong and unpleasant side effects, researchers     are interested in finding drugs that can be given in combination with cyclophosphamide that     will allow a lower dose of cyclophosphamide to be given with similar effects. The combination     of ABT-88 and cyclophosphamide may be an effective treatment for some types of cancer, such     as certain kinds of breast or ovarian cancer and non-Hodgkin's lymphoma that often do not     respond to standard therapies.      Objectives:      - To evaluate the safety and effectiveness of ABT-888 and cyclophosphamide in ovarian and     breast cancer and in non-Hodgkin's lymphoma that have not responded to standard treatments.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with (1) (Breast cancer 1/2)     BRCA1/2 ovarian cancer, primary peritoneal or ovarian high-grade carcinoma, or fallopian tube     cancer; (2) triple-negative breast cancer (not responsive to hormone-related therapy); or (3)     low grade non-Hodgkin's lymphoma.      Design:        -  Participants will be screened with a full medical history and physical examination,          blood and urine tests, and tumor imaging studies. Participants will be divided into two          groups with different treatment subgroups.        -  Group 1: Participants who have BRCA-positive ovarian cancer, primary peritoneal or          ovarian high-grade serous carcinoma, or fallopian tube cancer        -  Participants will receive either the combination of ABT-888 and cyclophosphamide, or          cyclophosphamide alone.        -  Participants will take the study drug by mouth once a day for 21-day cycles of          treatment, and will keep a diary to record drug doses and any side effects.        -  Participants will have clinic visits with blood and urine tests, imaging studies, and          other examinations on days 1, 2, 7, and 14 of cycle 1, and on the first day of all other          cycles.        -  Group 2: Participants who have triple-negative breast cancer or non-Hodgkin's lymphoma        -  Participants will receive either the combination of ABT-888 and cyclophosphamide, or          cyclophosphamide alone.        -  Participants will take the study drug by mouth once a day for 21-day cycles of          treatment, and will keep a diary to record drug doses and any side effects.        -  Participants will have clinic visits with blood and urine tests, imaging studies, and          other examinations on days 1, 2, 7, and 14 of cycle 1, and on the first day of all other          cycles.        -  Participants receiving only cyclophosphamide who show signs of disease progression after          tumor imaging studies can receive the combination of ABT-888 with cyclophosphamide.        -  Treatment will continue as long as participants tolerate the drugs and the disease does          not progress.   "
151101|NCT01306019|"     Background:        -  X-linked severe combined immunodeficiency (XSCID) is caused by a genetic abnormality in          the IL2RG gene that affects the growth and development of immune cells such as white          blood cells. Individuals with XSCID have difficulty fighting infections, which may lead          to chronic or severe illness and death. The primary treatment for XSCID is replacement          of the patient s immune system with a normal immune system through a bone marrow          transplant. The best outcomes in transplant patients are achieved when the bone marrow          comes from a sibling, but parents and matching unrelated donors can provide bone marrow          for transplant as well. However, because these transplant procedures are not always          effective, researchers are studying gene transfer treatment as an approach to treating          XSCID.        -  Lentiviral gene transfer treatment uses good genes to replace defective genes. A          lentivirus is a virus that has been modified to carry corrected genes into the blood          through corrected stem cells. By collecting an individual s stem cells and modifying          them with a lentivirus, the gene-corrected cells can be returned into the blood to help          produce normal healthy immune cells. Gene transfer treatment with lentivirus vector has          been used in humans but has never been studied in patients with XSCID.      Objectives:      - To determine the safety and effectiveness of lentiviral gene transfer as a treatment for     children and adolescents with X-linked severe combined immunodeficiency.      Eligibility:      - Children and adolescents between 2 and 20 years of age who have XSCID related to a defect     in the IL2RG gene and who are not currently under treatment with strong immune-modulating or     chemotherapy drugs.      Design:        -  Participants will be screened with a medical history, physical examination, blood and          urine tests, and bone marrow samples to collect stem cells for the procedure.        -  Participants will be admitted to the National Institutes of Health Clinical Center 11 to          12 days before receiving gene-corrected blood stem cells.        -  Participants will receive palifermin for 3 days, followed by busulfan for 2 days.          Palifermin will help prevent side effects from busulfan, and busulfan will help suppress          the immune system in preparation for the gene transfer. Participants will have regular          blood tests during this preparation period.        -  Participants will receive a transfer of their corrected blood stem cells about 36 to 48          hours after the second dose of busulfan. The cells will be injected over 5 to 10 minutes          under close monitoring.        -  The day after the transfer, participants will have 3 more days of palifermin.        -  Participants will remain in the hospital for several weeks, possibly as long as 6 weeks,          while the response to treatment is monitored.        -  Participants will continue to be monitored for immune function and possible side effects          after leaving the hospital, and will be followed for up to 15 years after the procedure          to evaluate the long-term effects of gene transfer therapy. The monitoring will involve          regular physical exams and blood samples.   "
151102|NCT01306006|"     The national Expanded Programme on Immunization (EPI) in Guinea-Bissau focuses its efforts     exclusively on children below 12 months of age; children who have reached 12 months of age     are no longer entitled to vaccines through the EPI program. This has affected the measles     vaccination coverage, approx. 30% of the children in the rural area do not receive measles     vaccine (MV).      Studies from the Bandim Health Project (BHP) have shown that MV has a profound impact on     survival, reducing mortality by approximately 50% - far more than can be explained by     prevention of measles deaths. Hence, MV seems to have non-specific beneficial effects on     survival, and the current policy may have important consequences for overall child mortality.      To test the implications of the current policy of only vaccinating children below 12 months     of age, the investigators will conduct a cluster randomized trial, in which children will     receive their vaccines according to the current national EPI policy (National policy) or     receive MV regardless of age and whether some doses of MV may be lost (MV-for-all policy).      The investigators hypothesise that among children enrolled after 12 months of age, mortality     is 50% lower in children randomised to receive MV compared with children randomised to follow     the national policy and not receive MV.   "
151103|NCT01305993|"     The purpose of this study is to determine efficacy of SB injection in Gastric Cancer.   "
151104|NCT01305980|"     The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.   "
151105|NCT01305967|"     The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung     Cancer.   "
151106|NCT01305954|"     The primary purpose of this study is to measure the association between baseline expression     of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in     patients with breast cancer. Patients with Stage I-IV breast cancer will be included and     myelosuppression will be assessed after the first cycle of chemotherapy via measurement of an     absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study     subjects will also be asked to complete a brief health behaviors questionnaire to gather     information on other relevant variables.   "
151107|NCT01305941|"     Purpose: This study is a single-arm, open-label phase II clinical trial testing the     hypothesis that daily everolimus plus weekly vinorelbine and trastuzumab will be effective,     safe, and tolerable among patients with HER2-positive breast cancer brain metastases. Once     enrolled, patients will receive everolimus PO daily in combination with weekly intravenous     (IV) vinorelbine and trastuzumab. Cycles will be repeated every 3 weeks (21 days). At the     time of progression, patients will come off study.      Participants: Up to 35 adults over 21 with HER-2 positive breast cancer that has metastasized     to the brain.   "
151108|NCT01305928|"     Post-discharge support is a key component of effective treatment for hospitalized smokers,     but very few hospitals provide it. Linking hospitalized smokers with free, proactive tobacco     quitlines is an ideal way to provide supportive contact at discharge, because quitlines are     effective and cost effective for smoking cessation. Many hospitals are beginning to fax-refer     smokers to quitlines at discharge. Fax referral is convenient and is part of the current     culture of medical communication channels. However, less than half of fax-referred smokers     are successfully contacted and enrolled in quitline services. Warm hand-off is a novel     approach to care transitions in which health care providers directly link patients that have     substance abuse and mental health problems with specialists, using face-to-face or phone     transfer. Warm hand-off achieves very high rates of treatment enrollment for these highly     vulnerable groups.   "
151109|NCT01305915|"     As the number of women who survive breast cancer continues to grow, more attention is being     paid to their quality of life and the disease's long-term effects. The transition from     patient to survivor, also termed the re-entry transition, can be a very difficult and     stressful time. A brief psychosocial intervention delivered at this important transition time     may address the challenges that women face at re-entry, facilitating greater adaptation and     more optimal recovery. The purpose of the proposed RCT is to test the acceptability and     effectiveness of a single-session group psychoeducational intervention led by a     multi-disciplinary team on adjustment to survivorship. A randomized controlled trial design     (RCT) will be used to recruit 440 women attending the breast clinic at Princess Margaret     Hospital in Toronto. Participants will be recruited while completing their adjuvant     radiotherapy and those who agree to participate will complete the baseline questionnaire     package (T0). They then will be randomized to receive either: (1) standard print material     (CRL group n=220); or (2) standard print material and a single session group     psychoeducational intervention (INT group n=220). Two weeks following randomization,     participants in the CRL group will be given the Getting Back on Track: Life after Treatment     booklet (current standard care), which includes information on the new health care team,     physical side-effects, diet and exercise, emotional and social needs and returning to     everyday life. Participants in the INT group will receive the same booklet and will also     attend a 2- hour psychoeducational group session facilitated by a multidisciplinary team.     Participants in both groups will be asked to complete the questionnaire package again at 3     months (post-1) and 6 -months (post-2) following the completion of cancer treatment.     Participants in the INV group will also be asked to rate their satisfaction with the class     and provide feedback on the content. The proposed intervention will be one of the few     clinical interventions designed to address the service gap in helping women to make the     transition from patients to survivors by using a single-session psychoeducational group     intervention.   "
151110|NCT01305902|"     The purpose of this pilot study is to estimate the effect size of a contingency management     procedure that reinforces walking at rates consistent with the American College of Sports     Medicine recommendations of 10,000 or more steps per day in older adults. We expect that     participants randomized to the contingency management intervention will increase walking to a     greater degree than those assigned to a standard care condition.   "
151111|NCT01305889|"     The focus of this study is to gather preliminary data regarding the effects of a     psychological therapy—Problem Solving Therapy—and an antidepressant medication—sertraline—on     1) cerebral perfusion (CP), 2) brain derived neurotrophic factor (BDNF), and 3) measures of     cognitive function in subjects with late life major depression (LLMD). This research goal     will be achieved by recruiting 38 individuals over the age of 65 with LLMD. The primary     outcomes will be change in CP, change in BDNF, and change in cognitive measures from baseline     to the end of 12 weeks of either therapy. We will also examine predictors of treatment     outcome including severity of executive dysfunction, baseline BDNF concentrations, and     baseline CP measures. The baseline neuropsychological testing, brain imaging, and depression     assessment will be obtained in a companion study (PI S. Mackin; CHR #H42689-32681-01) that is     IRB approved and is already in progress. In the current study a baseline serum BDNF level     will be added to Dr. Mackin's protocol. Patients will then receive either 12 weeks of Problem     Solving Therapy or antidepressant treatment with sertraline. Both treatments are evidence     based and commonly administered in our clinic. Outcome variables will be measures of     depression severity, the BDNF serum concentration, cerebral perfusion using a MRI arterial     spin labeling (ASL) technique and cognitive changes in memory and executive dysfunction. This     is a preliminary or pilot study. The primary objectives are to determine if the methods     appear feasible and to determine if change in BDNF or CP occur after treatment and     secondarily to determine if there are changes in cognitive functioning. The study is not     powered to show differences between treatments. The hypotheses are 1) PST will result in     increased perfusion in frontal regions of the brain but that frontal perfusion will not     change with sertraline; 2)sertraline will result in an increase in BDNF but PST will not.     Change in cognitive measures of memory, learning, and executive dysfunction will be examined     on an exploratory basis.   "
151112|NCT01305876|"     Yoga is becoming a part of therapies for children with emotional behavioral disorders. The     goal is to examine the feasibility and efficacy of yoga sessions for children with emotional     behavioral disorders at an urban elementary school.   "
151113|NCT01305863|"     Researchers are actively seeking a way to coat the inside of a synthetic graft so that it     more closely resembles native vessels and therefore has low thrombogenicity and low incidence     of stenosis. Using a biological coating comprised of autologous stromal cells derived from     the patient's own adipose tissue is a logical solution. Considerable experimental evidence     exists that such a coating is relatively non-thrombogenic and improves long-term graft     patency.      The Company's TGI Cell Isolation System (CIS) for isolating and concentrating adipose-derived     stromal cells (ASC) can be used to fill the pressing medical need for small-diameter     synthetic vascular grafts. The TGI CIS enables the user to prepare a stem cell-based     biological coating from adipose tissue liposuctioned from the patient. The cells derived from     the adipose tissue are then sodded onto the internal lumen of the vascular graft to improve     long term patency.   "
151114|NCT01305850|"     This is a prospective, randomized, placebo controlled, multi-center clinical trial to     determine whether aliskiren or aliskiren plus losartan or enalapril plus losartan effects on     peritoneal membrane transportation.   "
151115|NCT01305837|"     The purpose of this study is to determine whether cyclic oral methylprednisolone once every     month has an effect on the intrathecal inflammation in patients suffering from progressive     multiple sclerosis.   "
151116|NCT01305824|"     The purpose of this study is to determine if PRT-201 when applied to a limited segment of     your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous     fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been     shown to help keep vessels open (patent) when applied to the outside surface of the blood     vessels (arteries and veins) in AVF patients in a previous study.   "
151117|NCT01305811|"     This unblinded Phase II clinical trial tested the effects of individualized acupuncture     treatments offered in extant acupuncture practices in the community; practitioners had at     least 5 years of experience plus additional training provided by the study. Veterans with     diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly     acupuncture treatments (group 1, n=52) or 2 months of waitlist followed by weekly acupuncture     treatments (group 2, n=52). Measurements were taken at baseline, 2, 4 and 6 months. The     primary outcome is the SF-36 physical component scale score (SF-36P).   "
151118|NCT01305798|"     The goal of this project is to see if behavioral nudges will increase an individual's     likelihood of participating in a biometric screening. The behavioral nudges under     consideration are assigning preselected time-slots, encouraging subjects to make an active     choice, and sending reminders.   "
151119|NCT01305785|"     The AMIS Plus national registry collects and analyzes data on patients with acute myocardial     infarction in Switzerland in the pre-admission, hospital and follow-up phases. Emphasis is     placed on the evaluation of risk factors, diagnostics, urgent therapy strategies and     treatment of acute coronary syndrome. The AMIS Plus data gathered are important for assessing     guidelines, improving compliance with guidelines in clinical practice, investigating patient     groups not extensively studied in large randomized trials, quality assurance as well as the     continuous improvement of therapeutic strategies based on a large database.   "
151120|NCT01305772|"     The purpose of this study was to identify which cancer-related genes are turned on or turned     off in order to determine how well a patient will respond to the study drug, panitumumab.     Panitumumab was added to standard adjuvant or primary radiation therapy. There were subjects     that receive surgery followed by therapy and subjects that receive radiation therapy without     surgery.      Subjects entering this study had locally advanced disease that can be treated with surgery     and/or radiation therapy. Fresh frozen tumor tissue were available for genomics analysis     prior to initiating panitumumab therapy. If fresh frozen tissue was not available at time of     consent, a biopsy was required to participate in this trial.   "
151121|NCT01305759|"     The project runs as a Ph.d. project at the Faculty of Health Sciences- University of     Copenhagen.      In Denmark the investigators operate around 16.000 artificial hips and knees yearly, mainly     due to osteoarthritis. The numbers has increased with 13,9% for hips and 50,7% for knees in     the period 2004 to 2007. In 10% of the cases, or approximately 1.600 patients, the patient is     younger than 50 years - mid-life, working, socially active and sexually active. The     investigators have a tendency within in the orthopedic society to mainly focus on the     technological aspects of the procedure and tend to forget that this is a key event for the     patient with widespread consequences for the patient and his future life.      Hip- and knee arthroplasties is without no doubt two of the most important and successfully     surgical procedures ever introduced. The economical cost for osteoarthritis treatment has     exploded in the developed world over the last decade, with a yearly growth on 8%.      Because of the limited lifetime for an artificial hip or knee, this treatment can be     unfortunate for the young patient. This has over the last years led to an increased interest     for joint preserving surgery. Over the last twenty years it has been tried to delay the time     for total hip arthroplasties for patients with hip dysplasia with the aid of Ganz osteotomy.     Since this technique was introduced back in 1988, the research on the topic has had its main     focus on optimizing the operation technique. So as with surgery with artificial hip or knee     the investigators have a lack of knowledge regarding the social, work related, psychological     and sexual aspects of this treatment.      Purpose The consequences of an artificial hip or knee joint regarding patients' social-life,     work, psychological and sexual aspects gain very little attention international. The     investigators apply most of our research funds exclusively to research and development of the     surgical track and procedure, new prosthesis designs or coatings. The investigators find this     study highly relevant because this kind of studies has been preformed for several chronic     diseases but not osteoarthritis and its treatment.      With this study the investigators wish to examine the social, work related, psychological and     sexual aspects of end stage osteoarthritis. This will lead the way for improved information     to the patient and improve the surgeons' possibilities for chosen the correct time for     surgery.   "
151122|NCT01305746|"     The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.   "
151123|NCT01305733|"     The primary objective is to evaluate whether local infiltration analgesia (LIA) will reduce     oxycodone consumption during the first 48 postoperative hours in patients undergoing total     knee arthroplasty (TKA).   "
151124|NCT01305720|"     Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside     investigation of cerebral and mesenteric oxygenation in newborn infants. Using this technique     the investigators investigated the effect of mydriatic eye drops on cerebral and mesenteric     oxygenation in preterm infants   "
151163|NCT01305213|"     This randomized phase II trial studies how well bevacizumab with or without fosbretabulin     tromethamine works in treating patients with ovarian epithelial, fallopian tube, or     peritoneal cavity cancer that has come back or is persistent. Monoclonal antibodies, such as     bevacizumab, find tumor cells and help kill them. Bevacizumab and fosbretabulin tromethamine     may stop the growth of ovarian cancer by blocking blood flow to the tumor. It is not yet     known whether bevacizumab is more effective with or without fosbretabulin tromethamine in     treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.   "
194798|NCT00397826|"     To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients     with hypercholesterolemia.   "
151125|NCT01305707|"     OBJECTIVES:      To evaluate the comparative efficacy and security of Continuation Electroconvulsive Therapy     associated with pharmacotherapy versus pharmacotherapy alone in the prevention of depressive     relapse.      METHODS:      Demographic and clinical variables will be collected and side effects scales and     neurocognitive battery will be performed. Variables of efficacy: relapse percentage in both     groups in one year (primary variable); time without relapse. Main variable of security:     occurrence of side effects and neurocognitive performance.      DESIGN: Randomized controlled clinical trial.      SAMPLE:      104 outpatients diagnosed with unipolar depression (DSM-IV-R criteria) who had remitted with     a course of bilateral ECT. They will be randomized to two groups of treatment.      SETTING: Psychiatry Department at Bellvitge University Hospital.      ANALYSIS: Descriptive analysis of clinical variables; survive analysis and Cox model of     regression.   "
151126|NCT01305694|"     The study is a phase I/II trial designed to establish the safety and efficacy of intravenous     administration of bone marrow derived mesenchymal stem cells from related donor to patients     with relapsed/refractory aplastic anemia.   "
151127|NCT01305681|"     The primary objective of our study is to examine characteristics of bacteria that are     discovered in urine from pediatric patients that utilize either LoFric® or non-LoFric®     catheters for self intermittent catheterization. The investigators hypothesize that the     hydrophilic nature of the LoFric® catheter will alter the microbial environment and reduce     clinically significant urinary tract infections in patients with neurogenic bladder compared     to a similar population using standard catheters.      Secondary outcomes will be comparing the incidence of clinical urinary tract infections     between patients that use standard catheters and those that use LoFric catheters.      Lastly, patient satisfaction using LoFric catheters compared to standard catheters will be     assessed.   "
151128|NCT01305668|"     Chronic Obstructive Pulmonary Disease has two heterogeneous conditions (chronic bronchitis     and pulmonary emphysema phenotypes) with a different clinical presentation.      The phenotype evaluation in COPD patient (trough clinical, functional and radiographic     parameters) could influence final results in pharmacologic and non-pharmacologic management     of the disease.      The aim of our study is to investigate whether COPD patients with different disease phenotype     (chronic bronchitis versus pulmonary emphysema) have a different response to PR.   "
151129|NCT01305655|"     Early intervention in children and adolescents who experience delayed MTX-clearance and renal     dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses MTX to     non-toxic metabolites to avoid life threatening complications.   "
151130|NCT01305642|"     To analyze the weight gain of very low birth weight infants during a minimum period of three     weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been     individually fortified.   "
151131|NCT01305629|"     The proposed study uses a randomized controlled experimental design to evaluate the efficacy     of a brief intervention using spiritual self schema (3S+) counseling to simultaneously target     HIV health outcomes, and substance use among alcohol and/or drug dependent HIV positive older     adults (age 50+), relative to an attention control condition. Participants will be randomly     assigned to receive either: (1) 12 sessions of 3S+ counseling, adapted for the present study     to target both non-injection drug use, drinking, and HIV health; or (2) 12 sessions of     education about HIV health and the associated with alcohol and drug use that will serve as an     attention-control.   "
151132|NCT01305616|"     To investigate the effect of yellow-tinted IOLs on the Short Wave-length Automated Perimetry     (SWAP) and Standard Automated Perimetry (SAP) in patients with and without glaucoma.   "
151133|NCT01305603|"     Using Magnetic resonance (MR) scanning and ultrasonography the investigators wish to     investigate, in what way a known volume of local anesthetic injectate will be distributed in     the transverse abdominis plane (TAP) in young healthy male volunteers. The investigators     compare the anatomical distribution of the local anesthetic injectate in the TAP when     performing an ultrasound-guided classical TAP block and a Dual TAP block. The investigators     also want to compare the spread of anesthetized frontal dermatomes when performing an     ultrasound-guided classical TAP block and a Dual TAP block.   "
151134|NCT01305590|"     In anticipation of a pilot study incorporating behavioral economics into the treatment of     infectious diseases, we will conduct a survey with HIV/AIDS patients at the Ponce Clinic     (Infectious Disease Program of Grady Memorial Hospital, Emory University School of Medicine,     Atlanta, GA).   "
151135|NCT01305577|"     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of     submental fat (fat below the chin).   "
151136|NCT01305564|"     The Bard® Denali™ Retrievable Inferior Vena Cava (IVC) study is a prospective, multi-center     study which is intended to provide evidence of safety of the placement and retrieval of the     Bard® Denali™ Retrievable Inferior Vena Cava Filter in subjects requiring IVC interruption to     protect against pulmonary embolism (PE).   "
151137|NCT01305551|"     The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and     Metformin from a 5 mg Saxagliptin/500 mg Metformin extended release (XR) fixed dose     combination (FDC) tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil     by Merck S.A.) tablets administered together in both the fasted and fed states.   "
151138|NCT01305538|"     The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared     to placebo in the treatment of patients with post-herpetic neuralgia (PHN).   "
151139|NCT01305525|"     This is a prospective non-interventional 24 month post implant registry. Any patient that     receives a St. Jude Medical FDA approved implantable neuromodulation system is eligible for     enrollment. A minimum of 600 patients will be enrolled from a minimum of 30 sites.      Patients will be enrolled post-implant and followed for 24 months. Data are collected at     enrollment (within 30 days of device implant), and routine care follow-up visits at 3 months,     6 months, 12 months, 18 months and 24 months.   "
151140|NCT01305512|"     Evaluation of pharmacokinetic profile of SPARC1028   "
151164|NCT01305200|"     This randomized phase III trial is studying how well Caphosol rinse works in preventing     mucositis in young patients undergoing autologous or donor stem cell transplant.     Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth     sores, in patients undergoing stem cell transplant.   "
151165|NCT01305187|"     This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3     in the treatment of nasolabial folds   "
151141|NCT01305499|"     This research is being done to help us learn how to best use new drugs which may be active     against acute myeloid leukemia (AML). Two study drugs will be tested: 5AC (5-azacitidine) and     entinostat. 5AC improves blood counts in 50 - 60% of patients with MDS and has also shown     promise in AML. Entinostat has undergone early testing in patients with MDS and AML. It has     decreased the blast count in some patients' blood and bone marrow and has improved the blood     counts in some patients. The combinations of these two classes of drugs are well tolerated     and appear to work well together in laboratory tests.      A recent study at Johns Hopkins University administered 5AC and entinostat in an overlapping     schedule to patients with myelodysplastic syndrome (MDS), Chronic myelomonocytic leukemia     (CMMoL), and AML. The impressive results from this study have led to another phase II trial     to further examine this drug combination versus 5AC alone in these patients. In this study,     we want to see how the timing of when 5AC and entinostat are given affects the magnitude of     the disease response.   "
151142|NCT01305486|"     This will be an observational study designed to collect early, short- and long-term clinical     outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair. Subjects will be     expected to attend follow up visits at 1, 6, 12, 18 and 24 months following surgery.   "
151143|NCT01305473|"     This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing     Sepramesh at least 12 months before starting in this study.      The consented subjects' medical records will be reviewed for evidence of any risk factors of     hernia recurrence, procedure time, complications and any documented recurrences. The subjects     will be asked to undergo a physical exam to rule out any recurrences that were not documented     in the medical records.   "
151144|NCT01305460|"     A phase I/II study of the efficacy and safety of an intensified schedule of Azacitidine     (Vidaza®) in intermediate-2 and high risk MDS patients.   "
151145|NCT01305447|"     Adult female smokers will participate in an exercise-aided smoking cessation program, and     will then be randomized into one of four cessation maintenance conditions: (a) Exercise     Maintenance only (b) Exercise Maintenance + Relapse Prevention Booklets(c) Relapse Prevention     Booklets + Contact and (d) Contact Control. Primary follow-up outcome is smoking behaviour.     Secondary outcomes include exercise behaviour, Physiological measures (body composition     (Dual-emission X-ray absorptiometry; DXA), vascular health (stiffness, endothelial function,     carotid plaque volume), physical fitness), and Psychological measures (self-regulatory     cognitions related to exercise adherence [exercise, scheduling, barrier, relapse, and     concurrent self-regulatory self-efficacy]).      The hypotheses detailed below are specific to the randomization of participants into the     following 4 groups:        1. Exercise Maintenance only        2. Exercise Maintenance + Relapse Prevention Booklets        3. Relapse Prevention Booklets + Contact        4. Contact Control      Hypothesis 1: Compared to quitters in the contact control condition, quitters exposed to a     home-based lifestyle exercise maintenance intervention (Exercise Maintenance only and     Exercise Maintenance + Relapse Prevention Booklets) will demonstrate significantly greater     exercise adherence and fitness levels, as well as significantly less weight gain and smoking     relapse rates following exercise-aided smoking cessation program termination.      Hypothesis 2: Compared to quitters in the contact control condition, quitters exposed to     relapse information only (Relapse Prevention Booklets + Contact) will experience     significantly less smoking relapse following exercise-aided smoking cessation program     termination.      Due to the novelty and exploratory nature of the respective prevention programs, no     hypotheses are specified with respect to which prevention program (exercise maintenance or     relapse prevention information) will be superior to the other, or whether the additive     benefits (i.e., exercise maintenance plus relapse prevention information) will be superior to     one prevention program alone.   "
151146|NCT01305434|"     Mulberry leaf teas or extracts are used as a natural remedy for diabetes in some countries.     Animal studies have shown some effect of mulberry leaf extract on blood glucose. The purpose     of this trial is to assess the effect of mulberry leaf extract on type 2 diabetics, by     measuring blood glucose two hours after eating a meal and taking a capsule containing either     mulberry leaf extract or a placebo.   "
151147|NCT01305421|"     ICU patients do experience extubation failure. Guidelines rarely include muscle strength     criteria. Prior work indicates that grip strength is a reliable surrogate for muscle     strength. The purpose of the study is to assess the success rate of mechanical ventilation     weaning based on the grip test.   "
151148|NCT01305408|"     The primary objective of the study is to determine whether armodafinil treatment, at a dosage     of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood     stabilizers for treatment of adults with major depression associated with bipolar I disorder.   "
151149|NCT01305395|"     1. Early initiation of sirolimus will prevent or delay the development of intimal          thickening and subsequent graft failure.        2. Treatment guided by the development of cardiac allograft vasculopathy (CAV) on          intravascular ultrasound (IVUS) will be more effective in delaying progression of CAV          compared to treatment guided by angiography.        3. Prevention of the development and progression of intimal thickness on IVUS will prevent          the development of heart failure, graft dysfunction, and cardiovascular death related to          CAV.        4. Small artery elasticity predicts progression of cardiac allograft vasculopathy and is          modified by sirolimus        5. Patients who have no progression of CAV will have favorable improvement in biomarkers          and endothelial cells compared to patients who have progression of CAV   "
151150|NCT01305382|"     Abnormal peripheral endothelial function and alterations in circulating biomarkers that are     associated with endothelial activation and inflammation correlate with angiographic evidence     of cardiac allograft vasculopathy, defined as greater than 25% stenosis in a major coronary     artery.   "
151151|NCT01305369|"     Cysteinyl leukotrienes (cys-LTs) are lipid inflammatory mediators that abound in mucosal     inflammation and play a validated role in the pathogenesis of human asthma. It has recently     been demonstrated that the platelet adenosine diphosphate (ADP) receptor, P2Y12, is required     for LT4-mediated pulmonary inflammation and could be a novel potential therapeutic target for     asthma. Thienopyridines (such as ticlopidine and clopidogrel) are pro-drugs, with proven     antithrombotic efficacy, whose active metabolites selectively inhibit the platelet P2Y12     receptors. One of the drawbacks of thienopyridines is the high inter-individual variability     in pharmacological response, mostly due to the high inter-individual variability in the     capacity of transforming the pro-drug in its active metabolite. Prasugrel is a new member of     the class of thienopyridines, with faster onset of action and a more uniform inhibition of     platelet function compared to the other thienopyridines. Primary objective of our study will     be to test whether or not the inhibition of the platelet P2Y12 receptor by prasugrel reduces     the bronchial hyper-reactivity in patients with chronic asthma. The investigators designed a     randomized, double blind (Subject, Caregiver, Investigator, Outcomes Assessor), crossover,     placebo-controlled, prospective study, which will enroll 26 patients. Randomization will be     performed in sequential blocks. Patients will be blindly and randomly allocated to treatment     A (prasugrel 10 mg daily) or B (placebo) for 15 days. After a 15-day wash-out period,     patients who had initially been allocated to treatment A will be allocated to treatment     B, and vice versa. Measurements will be done at baseline and on day 15 after each     treatment, at the same time (+/- 1 h) of the day. Primary efficacy measure will be changes in     airway hyper-responsiveness, recorded as reduction of FEV1 using the mannitol test induction.     Secondary efficacy measures will be changes in markers of airway inflammation in sputum,     changes in measurement of nitric oxide expiration (as surrogate marker of airway lung     inflammation), count of eosinophil granulocytes in peripheral blood smear, changes in asthma     exacerbation rates and symptom scores. Changes in phosphorylation of platelet VASP     (Vasodilator-stimulated phosphoprotein) by ADP, measured with a flow cytometric technique,     will be used as markers of the degree of inhibition of platelet P2Y12 receptors attained in     each subjects by treatment with prasugrel.   "
154458|NCT01262105|"     The objective of this study is to determine whether the Air Barrier System device reduces     airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal     procedures.   "
151153|NCT01305343|"     240 subjects with high risk adult spinal deformity requiring surgical correction will be     enrolled in a prospective multi-center international study. High risk patients are defined     by either their diagnoses and/or the type of surgical intervention as listed in the inclusion     criteria. Neurologic complications in the form of new motor and sensory deficits will be     monitored prospectively in all patients at hospital discharge, and at 6 weeks (± 2 weeks) six     months (± 2 months) and 24 months(± 2 months) after the surgery. All new deficits will be     adjudicated for relationship to the surgical intervention.      Regression analyses will be used to evaluate the association between patient demographics, co     morbidities, treatment history, spinal deformity characteristics, surgical characteristics,     non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit     after surgery.   "
151154|NCT01305330|"     There is a rising incidence of incidentally detected small renal tumours due to improved     imaging techniques. Traditionally, patients diagnosed with these small renal masses undergo     surgery and therefore there is limited data about the natural history of these tumours.     Several small series have reported that most of these small masses grow slowly and might not     require early intervention and that only some masses grow rapidly requiring immediate     surgery. Presently, the investigators have not been able to identify prospectively which     masses are going to grow slowly. The investigators plan to use computed tomography (CT) and     Magnetic Resonance Imaging (MRI) parameters, microsatellite analysis and tissue analysis to     determine which masses will behave more aggressively. Additionally, the observations on the     natural history of small renal masses need to be validated with a multicentric and     systematically followed cohort.   "
151155|NCT01305317|"     This is double blind randomized controlled trial on the statins effects on serum IgG, IgA and     IgM level in chronic hemodialysis patients in Bandarabbas   "
151156|NCT01305304|"     Until now it has been assumed that regular endurance training has a positive influence on     cardiac function and that the positive effect increases with increasing intensity. However,     little is known about the effects of intense endurance stress on the heart. According to     current knowledge repeated exposure to strenuous endurance activity may lead to minor but     possibly irreversible damage to the heart with resultant scarring of the heart's muscle.      Within this study the investigators attempt to find out by different analytical methods - in     particular magnetic resonance imaging (MRI) and ultrasound of the heart - to what extent the     heart muscle is affected by long term intense endurance exercise and which changes in cardiac     function and morphology can possibly be found. Therefore the investigators compare former     national competitive endurance athletes with sedentary controls.   "
151157|NCT01305291|"     Emerging research suggests fiber, particularly digestion-resistant maltodextrins such as     Fibersol-2, may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing     satiety signals from the gut. This research aims to determine whether or not Fibersol-2 may     impact satiety, by decreasing hunger, prolonging satiation, and/or increasing satiety signals     from the gut.   "
151158|NCT01305278|"     Patients with a unilateral vestibular loss often complain of dizziness and imbalance.     Movement usually increases these symptoms often resulting in patients avoiding these     movements, causing further limitations in their activities of daily living. Vestibular     Rehabilitation (VR) involves a series of adaptation and balance exercises to improve symptoms     of postural stability. There is evidence that stroke patients gain benefit in their     rehabilitation from using gaming consoles (Nintendo Wii Balance) and we believe that similar     advantages can be shown for balance patients. We plan a 3 arm study. As there is a     considerable wait list for VR, the first arm will receive a Wii console and instructions to     use it on the wait list and during VR. The second arm will receive a Wii console and     instructions at the end of the waiting list and will use it during VR only and the control     group will receive no Wii. All will spend the same time on the wait list and will receive     identical assessments and VR   "
151159|NCT01305265|"     The purpose of this study is to test whether the incidence of sore throat and other tracheal     co-morbidities such as dysphagia and hoarseness can be lessened by use of a cuff manometer at     the beginning of surgery to inflate to the proper pressure compared to the standard     technique.      The investigators hypothesis is that inflation of the endotracheal balloon using a cuff     manometer immediately after intubation will reduce the incidence of sore throat and other     tracheal co-morbidities.   "
151160|NCT01305252|"     The Study Hypothesis:      Aggressive, upfront, dual therapy for treatment-naïve NYHA I/II/III PAH is superior to a     traditional step-up approach.      The study will evaluate:        1. Impact of dual, upfront, therapy on cardiovascular parameters in PAH as gauged by          cardiac magnetic resonance imaging (cMRI) at 24 weeks and event free survival at outcome          at 48 weeks.        2. Value of novel biomarkers (NT-pro BNP, Mts1/S100A4, and insulin resistance) and          cutting-edge imaging technologies (cardiac MRI) as newer endpoints for clinical trials          in PAH.        3. Utility of longer clinical trial design with the use of combined clinical events as time          to clinical worsening surrogate   "
151161|NCT01305239|"     Observational survey aiming to evaluate the tolerability of Aromasin and the ways in which it     is used in clinical practice in France (as adjuvant endocrine therapy).   "
151162|NCT01305226|"     This novel fibrinolytic agent is a 136 amino acid single chain protein secreted by some     strains of Staphylococcus aureus and readily produced by recombinant DNA technology. Two     natural variants of recombinant staphylokinase, THR-100 and SakSTAR, have been developed for     investigational use in preliminary trials. Like SK, it forms an equimolar complex with     plasmin which in turn activates plasminogen to plasmin. Unlike SK, the complexed, activated     molecule (which undergoes proteolytic cleavage of the first ten amino acids to generate     active staphylokinase) has a high degree of fibrin-selectivity in a human plasma milieu. This     fibrin-selectivity is due in large measure to potent activation at the clot surface by trace     amounts of plasmin, and rapid inactivation of the circulating complex by antiplasmin. Hence,     it provides an interesting and promising alternative therapy.   "
151166|NCT01305174|"     The objective of this prospective, randomized,controlled and multicenter trial is, to compare     recurrent-restenosis rates in the balloon expandable VISIO-PRO stent arm and the     selfexpandable PROTEGE GPS stent arm 12 month after treatment of stenosis or occlusions of     common and external iliac artery disease.   "
156666|NCT01233375|"     The purpose of this study is to determine whether CO-1.01 is safe and effective for treating     metastatic pancreatic cancer that did not respond to gemcitabine.   "
151174|NCT01305070|"     Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or     in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon     (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral, Invatec).   "
151175|NCT01305057|"     The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates     filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined.     Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated     with P-IP formulation on one side of the face and with a placebo formulation on the other     side twice daily (morning and evening) for 28 days. All subjects gave written informed     consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were     evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S.     ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.   "
151176|NCT01305044|"     Persons over age 65 years constitute a large and growing population of cancer survivors.     Available data indicate that both short- and long-term female breast cancer survivors report     more limitations related to strength and mobility than women with cancers of other sites and     women without a personal history of cancer. Further, better mental health among breast cancer     survivors has been shown to protect against physical decline and overall quality of life. The     combination of mental and physical interventions may result in substantial improvements in     quality of life. Tai Chi Chih (TCC), a form of mind-body exercise, is one such intervention.     TCC may be particularly suited toward elderly breast cancer survivors with impaired physical     and/or mental functioning, yet despite its increasing popularity and benefits in healthy and     diseased populations, its benefits have never been scientifically evaluated in this     population. The overarching goal of this study is to conduct preparatory work regarding the     effects of TCC on quality of life and physical function that will underpin future definitive     trials of TCC in elderly cancer survivors. As part of this 12-week trial, participants will     be randomized to a TCC or a health education control group (HEC). Establishment of meaningful     interventions that facilitate a more positive cancer survival experience in old age is an     important issue; there are substantial public health and clinical benefits should a TC     intervention be successful in this patient population.   "
151177|NCT01305031|"     In this randomized control trial, the investigators hypothesize that late-preterm infants     resuscitated with a low oxygen delivery strategy (initiation of resuscitation with room     air) will result in a significant reduction in oxidant stress without any harmful clinical     effects.   "
151178|NCT01305018|"     This study aims to evaluate the effects of branched-chain amino acids (BCAA) supplementation     on resistance exercise-induced muscle damage and inflammation.   "
151179|NCT01305005|"     -  To investigate ocular haemodynamics after phacoemulsification surgery        -  To evaluate the influence in people with different autoregulation of ocular blood flow   "
151180|NCT01304992|"     The objective of the study is to determine the efficacy of lupin protein drinks (Lupinus     angustifolius Boregine) in humans. Parameters concerning cardiovascular risk factors and the     metabolism of proteins, lipids and cholesterol will be evaluated.   "
151181|NCT01304979|"     Acupuncture has been studied in the perioperative setting and shown to reduce pain, anxiety,     nausea and vomiting. Studies have been conducted in orthopedic surgery patients, but not     spine patients. The investigators study will look at a combination of acupuncture therapies     for patients having low back spine fusions to assess pain levels and return to function.      114 subjects will be randomized into a direct acupuncture therapy group (38), an indirect     acupuncture therapy group (38), or usual care alone (38). All subjects will receive usual     care for spine fusion patients.      Direct acupuncture therapy subjects will have pre-op auricular seeds in four distinct ear     points bilaterally, an acupuncture treatment on the day after surgery and an acupuncture     treatment with gua sha on the 2nd day after surgery (typically day of discharge).      The indirect acupuncture therapy group will have treatment timed exactly as the direct     intervention group but consist of 'indirect' treatment: tape placed at ear points at pre-op,     ear seeds placed on several body points on the first and second day after surgery.      BPI, VAS, SPF36-2, and ODI measures will be taken at enrollment and at the 4-6 week follow-up     appointment with subjects' spine surgeon. BPI and VAS will also be taken at day 3 and day     7-10 additionally.   "
151182|NCT01304966|"     The purpose of the present study was to identify risk factors for more severe juvenile     Recurrent Respiratory Papillomatosis (RRP) through prospective evaluation of a pediatric     population in Thailand by the employing a protocol that includes staging of disease severity     using above mentioned staging system at the time of each endoscopic debridement, as well as     human papilloma virus (HPV) genotyping.   "
151183|NCT01304953|"     The role of 5-HT3A receptors in nociceptive processing has been demonstrated in several     animal models. However, studies in human volunteers have not been reported except for one     recent study suggesting that ondansetron could alleviate propofol-induced nociception.     Previous studies demonstrated that patients anaesthetized with sevoflurane have more pain     than those anaesthetized with propofol. And we further posit that the difference is due to     the nociceptive processing induced by the action of 5-HT3A receptors.      In this prospective, randomized, double-blind, placebo-controlled study, we assessed the     analgesic action of a 5-HT3A receptor antagonist (tropisetron) in women after gynaecological     laparoscopy under general anaesthesia maintained with either sevoflurane or propofol.   "
151867|NCT01295918|"     The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus     reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile infections     in children and adolescents.   "
151212|NCT01304576|"     The area of the brain responsible of visuospatial processing data and more specifically the     orientation of an object or image is located in parietal lobe, especially on the right side.     A dysfunction of this region would result in a disorder of recognition of the orientation of     objects and images that the investigators call orientation agnosia. Several isolated cases     are reported in the literature but to the investigators knowledge deficit has never been     systematically searched, or put into perspective compared to other neuropsychological     deficits. Moreover, the precise location of the lesion responsible for such a disorder     remains uncertain. The objectives of this study are (1) detect the existence of orientation     agnosia in case of right parietal lesion, and (2) to improve the understanding of such a     deficit allowing better management of this disorder.   "
151185|NCT01304927|"     Today, it is evident that vitamin D (VD) has more widespread effects than the classical     actions related to bone mineralization and calcium homeostasis1. VD deficiency results in     impaired reproductive performance in various species of animals, and recently the     investigators have shown that the VD receptor (VDR), activating (CYP2R1, CYP27A1, CYP27B1)     and inactivating (CYP24A1) enzymes are expressed in the human testis, epididymis, seminal     vesicle, prostate and spermatozoa. Our following functional studies showed that VD increases     intracellular calcium in mature spermatozoa, and hence may be important not only for     spermatogenesis but also for sperm maturation. A new, and yet unpublished cross sectional     study of 300 young healthy Danish men showed that men with lower levels of serum VD have     significantly lower number of normally developed and motile spermatozoa. Hitherto, most cases     of male infertility have been classified as idiopathic, and infertile couples have been     referred to symptomatic treatment at infertility clinics. These fertility treatments are     often physically demanding for the female partner as well as expensive for the health care     system. Any treatment that might improve semen quality of involuntary infertile men would be     beneficial both for the infertile couples and the society in general. Our findings that VD     may play a role for human semen quality have not yet been tested clinically. However, if VD     supplementation proves efficient this opens for the first time for a causal, safe and cheap     treatment of at least some cases of idiopathic impaired semen quality. The investigators     believe our new human data supported by the results from the VD deficient and VDR KO animal     studies and the high proportion of VD deficient Danish men provide sufficient evidence to     initiate a randomized clinical trial of VD supplementation to infertile men. Infertile men     have also have unfavorable altered levels of sex hormones and higher mortality than fertile     men. Since VD deficiency is associated with increased mortality, regulation of aromatase,     immune system, bone metabolism, glucose metabolism, cardiovascular system etc. our suggested     clinical trial may also be able to evaluate several secondary endpoints in addition to the     potential effect on semen quality.   "
151186|NCT01304914|"     In this study, the investigator will be approaching pregnant women to undertake 2 years of     weekly respiratory and nappy specimen collection from their healthy new born infant. These     specimens will be mailed to the Queensland Paediatric Infectious Diseases (Qpid) Laboratory     where they will be stored and batched tested for viruses and bacteria. As well as this,     parents will keep a simple daily symptom diary for their child, allowing us to match     detection of viruses and bacteria to periods when the study child did or did not have     symptoms. This will help our understanding of what finding these viruses and bacteria in     specimens from children really means.   "
151187|NCT01304901|"     The purpose of this study is to determine if adding single dose of oral montelukast to the     standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment     of acute wheezing provide additional clinical benefit in the emergency room.   "
151188|NCT01304888|"     The Programa de Apoyo Alimentaria (PAL) started in 2003 and is targeted to communities in     Mexico that do not receive benefits from other federal food aid programs, have less than     2,500 inhabitants and a high level of marginalization. Marginalization is a term used in     Mexico for the multidimensional assessment of poverty in a community.      When the program started in 2003 it provided beneficiary households either a cash transfer of     150 Mexican pesos (equivalent to approximately 14 USD at the time) per month or a monthly     food basket with a cost to the program of 150 pesos. The size of the cash transfer and the     amount of food was the same for all households, i.e. no adjustments for family size or     composition were made. The basket contained a number of staple and basic food products and     powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate (Table     1). The composition of the food basket conformed to the Mexican norm for food aid programs     (NOM-169-SSA1-1998), which states that food transfers need to provide at least 20% of the     recommended daily energy and protein requirements. Beneficiary households were required to     attend nutrition and health education sessions and had to participate in program related     logistic activities in order to receive the benefits. These program conditionalities,     however, were not strictly enforced.      A community randomized controlled intervention trial was used to evaluate the impact of the     intervention. A random sample of 208 rural communities was drawn from the pool of eligible     communities in 8 of the poorest states in the South/Eastern region of Mexico (Chiapas,     Guerrero, Oaxaca, Quintana Roo, Tabasco, Campeche, Yucatan and Veracruz). Within each     community a random sample of 33 households was selected. The baseline survey was conducted     from October 2003 to April 2004. After baseline data collection, the 208 selected communities     (6,687 households) randomly assigned to one of four study groups: food basket without     education (52 communities, 1657 households), food basket with education (52 communities, 1680     households), cash transfer with education (53 communities, 1687 communities) or control (51     communities, 1663 households). Treatment allocation was carried out by the Ministry of Social     Development.   "
151189|NCT01304875|"     When to start children with Fabry disease on therapy is controversial because of its expense     and inconvenience. Many Fabry children complain of exercise intolerance. In adults, the     investigators have found decreased lung function and ability to exercise on a treadmill.     Whether or not lung function and exercise capacity is abnormal in children is unknown. While     lung function and exercise tests are commonly part of routine evaluations for adults with     Fabry, they are not yet for children.      The objective of the proposed study is to more accurately define the lung and exercise     abnormalities in a group of 20 boys from 8-18 years of age with Fabry disease who have not     been treated with enzyme replacement therapy (Fabrazyme).   "
151190|NCT01304862|"     The purpose of this study is to determine whether mental health treatment disengagement may     be mitigated by reducing barriers to self-management and enhancing self-management skills.   "
151191|NCT01304849|"     The current standard treatment for advanced Hodgkin's lymphoma 6-8 cycles of ABVD     chemotherapy-this cures 70-80% patients. Those not cured after 8 cycles of ABVD have a poor     outcome (<10% survival). More intensive chemotherapy like Escalated BEACOPP (EB) achieve     higher cure rates have more side effects. Hence the investigators propose to use Interim PET     CT scan (done after 2 cycles of ABVD) for early identification of poor responders (it is     known that those with interim PET positive disease have a cure rate of less than 10-15% if     continued with ABVD alone) and to use EB selectively in this population in an attempt to     improve treatment outcomes - at the same time to limit side effects of therapy.      Thus, this study is an attempt to improve the outcome in the small subset of poor responders     to ABVD chemotherapy by the early use of Escalated BEACOPP chemotherapy   "
151193|NCT01304823|"     The purpose of this study is to determine the functional significance of sweet taste     receptors in the secretion of GI satiation peptides by using a specific sweet taste receptor     antagonist to block sweet taste perception in the gastrointestinal tract.   "
151194|NCT01304810|"     The purpose of the study is to obtain two year follow up data for subjects that received six     vaccinations of NicVAX in prior phase III studies. No treatment will be administered.     Anti-nicotine antibody levels and safety data will be collected.   "
151195|NCT01304797|"     This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a 3+3     design. Successive cohorts of three or more patients will be treated at escalating doses     until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified,     an Expansion Cohort will be enrolled at that dose to further characterize safety and     pharmacologic endpoints. Additional arms will be enrolled to explore the combination of     MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2     positive breast cancer.   "
151213|NCT01304563|"     Intradermal influenza vaccination may result in better efficacy when compare to intramuscular     vaccination.   "
183932|NCT00250341|"     This is a Phase 4, single center study conducted in mild-to moderate asthmatics.   "
151197|NCT01304771|"     Probiotics are viable commensal microorganisms that promote the establishment of beneficial     microflora. Animal and human studies demonstrate that probiotics can enhance body's immune     response to stimuli. Mayo Clinic in conjunction with Agri-King Corporation has developed a     novel synbiotic called AKSB (Agri-King Synbiotic) that contains a probiotic bacterium     (Enterococcus faecium, microencapsulated SF68 or Ventrux ME 30), a probiotic yeast     (Saccharomyces cerevisiae, Lynside® Pro-Lay 1), and a prebiotic (fructo-oligosaccharide     [FOS], NutraFlora®). This phase I placebo-controlled trial of AKSB in normal human     volunteers, over 65 years of age, is designed to study the safety of this probiotic when     patients are also receiving an influenza vaccine. If this study shows that AKSB is safe then     our aim is to do a larger study to see if we can improve influenza vaccine immune response     while taking the probiotic compared to placebo.   "
151198|NCT01304758|"     The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided     focused ultrasound thermal ablation of a designated area in the brain of patients suffering     from medication-refractory Essential Tremor, using the ExAblate transcranial system.      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the     targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion     created in the ventralis intermedius nucleus of the thalamus.      The treatment begins with a series of standard diagnostic MR images to identify the location     and shape of tumor to be treated. The ExAblate computer uses the physician's designation of     the target volume to plan the best way to cover the target volume with small spots called     sonications. These treatment spots are cylinder shaped. Their size depends on sonication     power and duration. During the treatment, a specific MR scan, which can be processed to     identify changes in tissue temperature, provides a thermal map of the treatment volume to     confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress,     and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing     1000-element phased array transducer) positioned above the subject head. The ExAblate     transcranial system also includes means to immobilize the subject head, cool the interface     water, and software for CT analysis and phase correction computation.      The ExAblate transcranial system is an experimental device and is being investigated in this     study.   "
151199|NCT01304745|"     The purpose of the study is to evaluate and compare the effect of: 1 Educational and     counselling in groups, 2) Physical training in group with 3) Control group, on global- and     health related quality of life and coping in patients finished treatment for gynaecological     cancer.   "
151200|NCT01304732|"     This is a retrospective analysis of infection on catheters of pediatric oncology patients.   "
151201|NCT01304719|"     The current protocol aims to examine the effects of a computer-based intervention used in     conjunction with existing Healthy Families America (HFA) home visitation programs on the     challenges related to participant enrollment, retention, and motivation as well as parent and     child outcomes.   "
151202|NCT01304706|"     This study will assess the safety and utility of the new inserter for the administration of     ILUVIEN in subjects with diabetic macular edema.   "
151203|NCT01304693|"     The purpose of this study was to assess the safety, tolerability, and the effects of     treatment on ocular outcomes following a single intravitreal administration of ESBA1008     compared with LUCENTIS® in patients with exudative age-related macular degeneration (AMD).   "
151204|NCT01304680|"     Retrospective study to evaluate the characteristics of patients and of fluid resuscitation     during intensive care unit hospitalization of patients under septic chock.   "
151205|NCT01304667|"     This retrospective, multicenter study is designed to collect tumor characteristics as well as     treatment data from patients diagnosed with primary or recurrent squamous cell cancer of the     vulva with emphasis on indication and application of radio- and chemotherapy. Application of     chemotherapy in primary treatment of vulvar cancer is rare; the study collective is therefore     extended to relapsed disease.   "
151206|NCT01304654|"     Identify pediatric oncologic patients with ALI/ARDS at GRAACC/IOP's Pediatric Intensive Care     Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.   "
151207|NCT01304641|"     The purpose of this study is to compare rates and risk of primary cardiovascular events among     elderly patients newly initiating therapy with atorvastatin or simvastatin. The specific     objectives for this project are to: 1) examine the demographic and clinical characteristics     of the elderly patients in whom atorvastatin or simvastatin was newly initiated; and 2)     compare cardiovascular event rates in elderly patients in whom atorvastatin or simvastatin     was newly initiated.   "
151208|NCT01304628|"     The objective of this study is to evaluate if single subcutaneous (SC) doses of PL-3994,     administered to patients with asthma can achieve a clinically meaningful increase in     pulmonary function (Forced Expiratory Volume in one second: FEV1) while maintaining an     acceptable safety profile. The study will characterize the bronchodilator effect, dose and     safety of PL-3994 in a population of moderately severe, stable asthmatics following overnight     withdrawal of beta-2 agonists.   "
151209|NCT01304615|"     Foundations for Health is a 12-week behavioral weight loss interventions primarily conducted     via the internet aimed at helping overweight and obese young adults (ages 18-30) lose weight     by increasing physical activity, decreasing the energy density of the diet, and increasing     consumption of low energy dense self-made meals by providing culinary training skills.   "
151210|NCT01304602|"     This phase I trial will use the combination of irinotecan and BKM120 in patients with     advanced colorectal cancer who have failed on or have become intolerant of at least one line     of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy.   "
151211|NCT01304589|"     The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in     women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to     fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The     investigators will also determine whether associated symptoms in PVD, including psychological     distress, impairment of sexual function, physical function, and quality of life, are     correlated with a reduction in vulvar pain.   "
151868|NCT01295905|"     The purpose of this study is to evaluate the performance of an investigational daily     disposable contact lens.   "
151215|NCT01304537|"     Alpha-1 Antitrypsin (AAT), trade name (Glassia ®), is being explored in this phase I/II trial     as a potential disease modifying agent in Type 1 Diabetes Mellitus (T1DM) based on its     anti-inflammatory properties. AAT is an acute stress reactant protein that increases during     inflammation. In T1DM inflammation serves a major role in disease progression.   "
151216|NCT01304524|"     This is randomized, placebo controlled study to determine safety and efficacy of VGX-3100 DNA     Vaccine delivered by Electroporation to adult women with biopsy-proven HPV 16 or 18     associated Cervical intraepithelial neoplasia grade 2/3 or 3.   "
151217|NCT01304511|"     The purpose of this post-marketing surveillance is to identify problems and questions     regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of     premature luteinizing hormone (LH) surges in women undergoing controlled ovarian     hyperstimulation (COH) for assisted reproduction techniques (ART).   "
151218|NCT01304498|"     Primary objective:      • To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers     (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.      Secondary objectives:        -  To evaluate the tolerability of V503 in 9-15 year-old girls.        -  To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or          GARDASIL.   "
151219|NCT01304485|"     Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer     to select patients who may benefit from directed therapy   "
151220|NCT01304472|"     Clopidogrel administration is considered standard of care in patients with stable coronary     artery disease post PCI. However , a significant proportion of patients is considered     clopidogrel resistant and this is shown to be accompanied by future adverse events. The     hypothesis of the study is to define among consecutive outpatient clinics individuals with     stable coronary artery disease being on chronic clopidogrel treatment, those that are     clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel     resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or     clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment     crossover will be performed without a washout period. At Day 28 platelet reactivity will be     assessed as well.   "
151221|NCT01304459|"     Observational protocol to analyse routine vancomycin serum levels of patients under intensive     care and to obtain percentage of patients that achieve therapeutic values.   "
151222|NCT01304446|"     CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status     of cancer patients, leading to nutritional support. The aim was to study enteral nutrition     indications, as well as its compliance and the impact on nutritional status.      DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM.      METHODS: Patients older than 1 year followed during anticancer therapy were included from     January 2002 to January 2004. They received industrialized oral supplementation - Nutren 1.0     or Jr (IOS) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at     these times, if inadequate outcome was observed, tube feeding with the same supplement (TFR)     was indicated.   "
151223|NCT01304433|"     The study is primarily aimed to collect further data on the safety of the investigational     product in a large patient population when used in routine clinical practice in the     Asian-Pacific region.   "
151224|NCT01304420|"     The purpose of this study is to analyse the usability of ultrasonography together with     biomarkers in the investigation of patients diagnosed with juvenile idiopathic arthritis. The     investigators hypothesize that serum and urine markers of cartilage and bone synthesis and     degradation, together with ultrasound measurements of joint cartilage thickness, are useful     tools in the early evaluation of JIA patients, - as diagnostic, prognostic and monitoring     methods.   "
151225|NCT01304407|"     Osteosarcoma is the most common malignant bone tumor in children and adolescents. Because     cure rates for osteosarcoma have remained stagnant for the past several decades despite     numerous trials of chemotherapy agents, novel therapies based on the understanding of the     molecular pathogenesis of osteosarcoma are needed. Rothmund-Thomson Syndrome (RTS) is a     genetic disorder affecting many parts of the body and resulting in major skeletal     abnormalities. This disease also has the propensity to increase the risk of developing     cancer, particularly osteosarcoma. Two-thirds of RTS patients have a high risk of developing     osteosarcoma. Therefore, it is important to understand the impact of RTS on the skeletal     phenotype (as measured by calcium absorption and bone mineralization) in order to develop     effective therapies to battle osteosarcoma.   "
151226|NCT01304394|"     The primary objective of this study was to provide daily information on the performance     safety of the Ped3CB in practical therapeutic use in pediatric patients.   "
151241|NCT01304199|"     The purpose of this study is to assess the various aspects of life in the cancer survivors in     India. Cancer survivor is defined as an individual diagnosed with cancer and who has     survived the disease and treatment, and for the rest of his/her life.      Cancer survivors are at increased risk of developing various physical and psychosocial     conditions, which require to be identified and attended within the cancer care system.      Survivorship research is seen as addressing the medical, functional, and health related     issues of individuals diagnosed with cancer, as well as that of their families.   "
155311|NCT01250977|"     The objective of this proof-of-concept pilot study is to evaluate Donepezil HCL (Aricept),     for adherence, side effects and effects on smoking behavior in a population of dependent     smokers.   "
151242|NCT01304186|"     The purpose of this study is to evaluate the acceptability and efficacy of a computer-based     tailored information application designed to promote health literacy in persons treated for     HIV infection. The study hypothesis is that the application will be acceptable and usable for     persons treated for HIV infection, and will improve their levels of adherence to     antiretroviral medication treatment.   "
151243|NCT01304173|"     This is an observational study involving a retrospective review of medical records of adult     patients who have been treated with intravesical valrubicin for bladder carcinoma in situ     (CIS) since October 2009.   "
151244|NCT01304160|"     The purpose of this study is to evaluate the efficacy and safety of stereotactic radiation     therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients     with locally advanced pancreatic cancer.   "
151245|NCT01304147|"     The objective of the current study is to investigate the safety and efficacy of a single dose     of intranasal (IN) ketamine in treatment-resistant depression (TRD).   "
151227|NCT01304381|"     Patients with severe heart failure have as many symptoms as many patients with cancer but yet     do not have equal access to supportive and palliative care. They have an unpredictable course     of illness, which makes difficult to judge when the palliative stage has been reached. The     Heart failure and Palliative care Programme is a three-year project in Sweden financed by the     Swedish Association of Local Authorities and Regions (SALAR). The overall aim is to develop,     implement and evaluate a model that integrates cardiac care and palliative advanced home care     for patients with severe chronic heart failure. The primary aim is to study the effects on     patients' symptom burden, quality of life and activities of daily living. A randomized     controlled clinical study is planned.      Patients (n=62) with a confirmed diagnosis in accordance with the criteria proposed by the     European Society of Cardiology and with NYHA III-IV symptoms and at least one of following     criteria will be included;        1. At least one episode of worsening heart failure that resolved with injection / infusion          of diuretics or the addition of other heart failure treatment in the last 6 months and          regarded optimally treated according to the responsible physician.        2. Need for infusions-treatment.        3. Chronic poor quality of life (VAS < 50)        4. Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body          weight within the last 6-12 months)        5. less than one year life expectancy The participants will be randomized to intervention          or control group. The intervention consist of a multidisciplinary approach and          collaboration between specialist palliative and heart failure (HF) caregivers, in a          shared structured person-centred and identity-promoting care at home during six months.          Usual care is performed for the control group.   "
151228|NCT01304368|"     Chronic neck pain is a common worldwide problem. In the majority of cases, patients are     treated by medication, referral to a physiotherapist or thermotherapy. Thermotherapy - the     therapeutic application of topical heat - provides an easy to apply self-help strategy in     patients with chronic neck pain. However, despite the frequent use in clinical practice,     there is no research regarding this topic yet.      The aim of this study was to evaluate whether thermotherapy self-treatment for chronic neck     pain induces changes in perceived pain intensity and in sensory processing.   "
151229|NCT01304355|"     Irritable bowel syndrome (IBS) is a common disorder affecting up to 20% of the general     population. Despite the prevalence of the disorder, it remains poorly understood. This is     reflected in a symptom based diagnostic scheme, the lack of a suitable biological marker and     inadequate treatment options. Current knowledge suggests the disorder is as a result of a     dysregulated brain-gut axis, a complex construct describing the bidirectional communication     systems underpinning normal gastrointestinal functioning.      The investigators hypothesize here that the disruption of this brain-gut axis is facilitated     by an increased degradation of tryptophan along the kynurenine pathway. This metabolic     abnormality has the potential to impact on both GI and CNS signaling through its effects on     serotonergic signaling and the impact of metabolites like kynurenic acid and quinolinic acid     on cognitive processes respectively.      Previous data from our laboratory indicated increased tryptophan degradation in IBS patients     and suggested the metabolites produced as putative biological markers of the condition. In     this study the investigators aim to reconcile cognitive impairment in IBS with GI and CNS     symptom severity and kynurenine pathway metabolites.      The investigators will establish these baseline measures in IBS compared to control subjects.     A battery of cognitive assessments will be carried out using a computerized testing system.     Standardized rating scales will be used to assess GI and CNS symptom severity. GC-MS/MS, a     recently acquired technology platform in our laboratory, will be used to quantify plasma     quinolinic acid levels.   "
151230|NCT01304342|"     Addition of fentanyl or remifentanil to the propofol produced sedation for scheduled ERCP     will decrease the propofol requirements for predetermined sedation levels (as shown by     Bispectral Index Monitor (BIS) monitor), will be associated with faster recovery monitored by     Ramsay's and Observer's Assessment of Alertness/Sedation (OAAS) scores and BIS, less     postoperative pain (assessed by Visual Analogue Scale=VAS) and less early cognitive     impairment after sedation (as assessed by the MiniMental test).   "
151231|NCT01304329|"     The objective of the study is to investigate the drug-drug interaction potential between BI     10773 and simvastatin.   "
151232|NCT01304316|"     The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of     a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline   "
151233|NCT01304303|"     Phase I study of SPARC1023 alone and in combination with carboplatin   "
151234|NCT01304290|"     Our objective in this study will be to determine if implementing the glucose/insulin clamp     (GICT) on cadaveric organ donors can:        -  Prevent hyperglycaemia        -  Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours          therapy with the GICT prior to organ procurement.        -  Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant        -  Assess graft function by evaluating:             -  Liver: post-transplant liver function score (PTLF)             -  Kidney: graft function as defined by UNOS (immediate graft function IGF, slow graft               function SGF and delayed graft function DGF and             -  Pancreas: 7 day post-transplant insulin requirement, C-peptide and C-RP levels at               day one and seven post-transplantation   "
151235|NCT01304277|"     This study is designed to evaluate safety and PK/PD in Canadian Fabry patients.   "
151236|NCT01304264|"     To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is     statistically superior to twice a day (bid) timolol with regard to increasing ocular blood     flow   "
151237|NCT01304251|"     The purpose of this study is to determine the effect of short-term fasting on tolerance to     adjuvant chemotherapy in breast cancer patients   "
151238|NCT01304238|"     The purpose of this retrospective registry is to collect data about patients with acute HIT     II (Heparin-induced Thrombocytopenia type II) which were treated with Lepirudin, Danaparoid,     Argatroban or Fondaparinux. It is a main objective of this registry to mirror the daily     routine in this indication in Germany.   "
151239|NCT01304225|"     This study will investigate the clinical efficacy and safety of the PASCAL laser (PAttern     SCAn Laser) for diabetic retinopathy. Patients with proliferative or severe nonproliferative     retinopathy will be treated with panretinal photocoagulation utilizing different treatment     strategies. The investigators believe that using lower laser parameters, the clinical     response may be equivalent with less adverse effects.   "
151240|NCT01304212|"     The purpose of this study is to compare the analgesic effectiveness of three techniques: the     femoral nerve block, intraarticular infiltration or a combination of both in the control of     pain in total knee arthroplasty (KA). The hypothesis to be tested in this study is that the     performance multimodal postoperative pain KA combining two analgesic techniques to obtain     better analgesia than when applied separately.   "
151246|NCT01304134|"     To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in     the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v.     PCA.   "
151247|NCT01304121|"     This is a randomized clinical trial that will be carried out to examine the use of bioactive     glass granules (S53P4) as bone graft substitute in filling small and large bone defects as     compared with autogenous and allogeneic bone grafting, respectively.   "
151248|NCT01304108|"     Preventing the formation of blood clots in the veins so they do not injure leg veins or     travel to the lungs, also called venous thromboembolism prophylaxis (VTE-P) is an essential     component of safe in-patient care, yet it is deployed sub-optimally in many hospitals,     including The investigators own. Two prior VTE-P improvement projects were completed at Mayo     Clinic hospitals, one in the Department of Medicine, and the other in selected divisions of     the Department of Surgery. Both projects resulted in marked improvement in the percentage of     patients receiving appropriate VTE-P. This project seeks to utilize the lessons learned from     these two pilots along with known best practices for &quot;spreading&quot; to deploy methods     that enhance VTE-P to the entire hospitalized population. The investigators seek appropriate     VTE-P rates exceeding 95%.   "
151249|NCT01304095|"     The purpose of this study is to measure the effect of ranolazine on ETT (exercise treadmill     test) exercise duration in four ethnic subgroups with established coronary artery disease and     risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and     East Indian.   "
151250|NCT01304082|"     When one receives a local anesthetic, such as novocaine for a dental procedure, there is a     burning painful sensation experienced upon injection of the local anesthetic. We are trying     to understand the role of pH (how acidic a solution is) in the production of pain during     local anesthetic administration. We hypothesize that less acidic solutions produce less     burning. We also want to determine whether or not the pH of the solution affects the rate of     onset of the local anesthesia. We will recruit subjects from patients who have a clinical     indication for lumbar medial branch (LMB) nerve blocks, procedures frequently performed at     the Massachusetts General Hospital Center for Pain Medicine. For each patient, three nerve     blocks are administered at adjacent spinal levels, typically using either lidocaine or     bicarbonate-buffered lidocaine as the local anesthetic. We will add a saline control as part     of the research procedure and then provide lidocaine at the control location before     continuing with the nerve blocks. This clinical procedure offers an ideal opportunity to     compare the effects of the three solutions. There will be almost no deviation from the     standard clinical procedure. After the injection of each solution, the pain score on     administration of the medication will be recorded immediately. We will also provide a     continuous stimulation (pin taps) after the local anesthetic injection and record when the     patient experiences hypoesthesia (reduced sensation) and anesthesia (absent sensation).     Finally, we will record the pain score upon reinsertion of a needle to mark the precise     location (part of the clinical procedure) one minute after the local anesthetic injection.     All data will be collected during the a single clinical visit.      The study will conclude when 60 subjects have successfully been tested. Data will be reviewed     annually.   "
151251|NCT01304069|"     Tramadol is an opioid analgesic, which is widely used in the treatment of acute and     neuropathic pain. After oral administration, tramadol is rapidly and almost completely     absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed     by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation     is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral     tramadol with selecoxib and etoricoxib. Selecoxib is known to inhibit CYP2D6. Twelve healthy     male or female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of     the ideal weight for height are taken into the study. Primary endpoints of the study are     plasma concentrations of tramadol and its metabolites.   "
151252|NCT01304056|"     Respiratory muscles seem to be activating differently in critically ill patients than in     healthy persons. Needle electrodes would provide artefact-free signal information about     muscle activation. However, needle recordings are an invasive technique which limits its     feasibility in clinical setting. Intention of this study is to investigate if surface     electromyography could be used to measure recruitment patterns of ventilatory muscles.   "
151253|NCT01304043|"     To take charge of the treatment in rare adult ovarian tumors with an homogenous manner     (germinal and sexual cords tumors), at different stages of the disease.   "
151254|NCT01304030|"     Our research hypothesis is that residents who participate in the empathy and relational     skills training modules will significantly improve in these skills as compared to a control     group of residents who receive residency training as usual that includes the current standard     training in the doctor-patient relationship. To evaluate this hypothesis, we will use a     two-pronged approach to assessment. The first prong is the residents' self assessment of     empathy and the second is from the patients' perspective.   "
151255|NCT01304017|"     In Israel approximately 16,000 people have a stroke each year. Most of these people suffer     from weakness or paralysis of half of their body which leads to difficulties performing basic     activities of daily life (BADL) such as dressing and walking. Due to the stroke, these     individuals need to undergo intensive rehabilitation. After rehabilitation, physical activity     has been strongly recommended to maintain their functional level which was achieved during     rehabilitation. In addition regular physical activity can prevent secondary condition     However, recent findings suggest that people with stroke do not perform enough physical     activity with their upper and lower extremities.      The use of Virtual Reality (VR) for rehabilitation has been found to have potential for     encouraging active purposeful movement. Many researchers have assessed the feasibility &     usability of different VR systems and environments for individuals with stroke. Costly VR     systems in addition to off-the-shelf video game consoles (e.g. Sony PlayStation EyeToy,     Nintendo Wii) have been found to have great potential to encourage active purposeful     movement. However, to date, only a limited number of studies have investigated the     effectiveness of VR therapy post-stroke.      Since physical activity is important after stroke and the fact that individuals with stroke     are not participating sufficiently in physical activity, I suggest to carry out this study.      The overall aim of this study is to assess the effectiveness of using novel technology of VR     therapy to promote the participation in daily physical activity of individuals with stroke. A     'Community based' VR program will be compared to a traditional therapy program in promoting     daily physical activity of the lower and upper extremities.      It is hypothesized that the VR intervention will be more efficient than the traditional     therapy in promoting physical activity (walking and use of the weak upper extremity).   "
151256|NCT01304004|"     Worldwide, obesity rate has increased so much in the latest years, that we call it obesity     epidemic. Overweight could result of an unbalanced energetic balance for years. The person     who regularly consumes more calories than she expends will find herself with a positive     energetic balance, which results in a weight gain. A daily overconsumption of only 10     calories comes with a weight gain throughout one year. A way to avoid this overconsumption is     to eat food that increases satiety. Satiety can be defined as the time interval after food     ingestion, during which hunger and desire to eat are suppressed.      The general objective of the study is to investigate in a pilot study the impact of a     drinkable yogurt enriched in proteins and fibres on satiety.   "
151257|NCT01303991|"     The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate     based photodynamic therapy in patients with intermediate or high-risk transitional cell     carcinoma of the bladder.   "
151258|NCT01303978|"     Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin   "
151259|NCT01303965|"     One of the complications that can occur after a stem cell transplant is called graft versus     host disease (GVHD). Another complication is that multiple myeloma may come back (relapse).     In this study, a drug called lenalidomide will be started 1-2 months after a transplant, or     possibly later depending on recovery of your side effects. Lenalidomide and sirolimus have     been shown to work together against multiple myeloma. Therefore, lenalidomide will be     combined with sirolimus with the hope that this will help prolong the amount of time the     disease is in remission. Researchers hope these steps will help prolong the amount of time     the multiple myeloma is in remission and will decrease the chance of GvHD.   "
151260|NCT01303952|"     Evaluation of the efficacy and safety of eculizumab in symptomatic or transfusion-dependent     patients with untreated or refractory hemolytic cold agglutinin disease(CAD)   "
151261|NCT01303939|"     The purpose of the study is to determine if glaucoma is associated with neurodegenerative     changes in areas of the brain other than the occipital lobe. This will help guide the     direction of further research in the use of neuroprotective agents in preventing or     controlling such changes. The final goal is to improve the quality of life for patients with     glaucoma.   "
151262|NCT01303926|"     Cisplatin and pemetrexed combination or carboplatin, paclitaxel and bevacizumab are now     considered as standard treatment in non-squamous cell lung carcinoma (NSCLC). Both main     registrative trials are considered positive because they reached their objectives, but within     them, the Quality of Life (QoL) of patients was not detailed neither has represented as     primary objective of the studies. It is considered that, together with enhancements that are     added to the knowledge of the biology of NSCLC, QoL may influence the therapeutic choice if     one of the associations show to be better tolerated by the patient and favours an     amelioration of his QoL.   "
151263|NCT01303913|"     Oxygen desaturation (SO2 < 88-90%) during walking is a common clinical feature of Chronic     Obstructive Pulmonary Disease (COPD) patients. By a predicted analysis our study is aimed to     evaluate anthropometric and functional characteristics of COPD patients correlated with     oxygen desaturation during Six-minute walking test (6MWT).   "
151264|NCT01303900|"     Life expectancy of hemophilia patients has improved considerably during the past decades and     is approaching that of the general population. Hemophilia patients are therefore likely to be     confronted with age-related disorders in addition to their primary illness and related     diseases. Little is known about the occurrence of age-related co-morbidity, especially     cardiovascular disease (CVD), in these patients. Low clotting factor levels are hypothesized     to protect against both atherosclerosis and thrombus formation, resulting in a reduced risk     of ischemic CVD. CVD mortality has been reported to be lower in haemophilia patients than in     the general population, but data on non-fatal CVD are lacking, and no adjustment for CVD risk     factors has been made so far.      The aim of our study is to assess the occurrence of CVD and its risk factors in a large     cohort of haemophilia patients.      In this prospective multicenter cohort study in a group of 700-800 male patients with     haemophilia A or B aged 30 years or older from The Netherlands and the UK, data on CVD     history and CVD risk factors will be collected at baseline and compared with the general     age-matched male population. Overall QRISK2 cardiovascular risk scores will be calculated and     also compared with the general population. During a follow-up period of 5 and 10 years the     occurrence of CVD events will be recorded and compared with the expected occurrence based on     the QRISK2 scores and with data from the general population.   "
151265|NCT01303887|"     The purpose of this study is to determine whether R-FC is more beneficial that R-CVP in the     treatment of older patients (aged 60 or over) with Follicular Lymphoma (FL).   "
151266|NCT01303874|"     TRIAL DESIGN        1. Description This is a 18-month, double-blind, randomized, multicentre, outpatient study.          The approximate duration of subject participation will be 18 months and the approximate          total duration of the study will be 42 months. The duration of subject enrollment will          be approximately 24 months.        2. Discussion of Trial Design The study is designed to directly compare the effectiveness          of combination therapy with MTX + ETN versus        3. Principal research question/objective To determine the number of patients in clinical          remission at 12 months of follow−up, as defined as the absence of symptoms and signs of          inflammatory arthritis.   "
151267|NCT01303861|"     This study focuses on the first step in developing an algorithm for maximizing quit-smoking     success based on an adaptive approach, which changes treatment from the initial nicotine     replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT     non-responders are switched (in double-blind fashion) before the quit date to receive     either varenicline alone or varenicline paired with bupropion. Some participants who would     otherwise have failed at their quit smoking attempt could be rescued by switching to     alternative pharmacotherapies. The proposed study will evaluate the combination treatment     against varenicline alone in an adaptive trial design   "
151268|NCT01303848|"     To elucidate whether blood lactate, lipid transfer proteins and PPARs/CLOCK/Bal1 have a     circadian rhythm   "
151269|NCT01303835|"     To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in high     grade glioma patients undergoing standard chemoradiation   "
151869|NCT01295892|"     This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory     biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese     women after three months of follow-up intervention.   "
151270|NCT01303822|"     Emotional and mental symptoms are common consequences of cancer diagnosis and treatment.     Coping with these symptoms seems to be influenced by interpretation of illness, locus of     health control and spiritual attitudes in dealing with illness.      Mindfulness-based stress reduction has been shown to reduce physical and mental symptoms in     cancer patients.      The aim of this study is to investigate the effect of a mindfulness-based day-care clinic     group program on quality of life, anxiety and depression in cancer patients and to evaluate     the association with coping styles, spiritual attitudes in dealing with illness, mindfulness     and interpretation of illness.   "
151271|NCT01303809|"     The investigators wish to standardise and optimise perioperative care for consecutive     patients undergoing laparoscopic sleeve gastrectomy for weight loss. The investigators will     compare patients under a standardised perioperative care program to patients who undergo     routine perioperative in our hospital and determine whether patients who had optimised     perioperative care went home earlier and had fewer complications.   "
151272|NCT01303796|"     This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at     least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the     doctor does not recommend the use of standard intensive treatment or the patient has decided     not to receive standard intensive treatment after being fully informed about its benefits and     risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating     cycles with decitabine, or decitabine alone. The purpose of the study is to learn which drug     regimen is more likely to keep AML in check as long as possible.   "
151273|NCT01303783|"     The purpose of this study is to determine the blood pressure lowering responses of various     dose combinations of nifedipine GITS and candesartan as compared to treatment with each     component on their own (monotherapy) and placebo (a look-alike tablet without active     ingredient). The drugs - nifedipine GITS and candesartan - which are being investigated are     currently approved for use in patients with essential hypertension alone or together with     other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS     and candesartan used together in the treatment of essential hypertension has not been     established yet. In this study patients will be treated with various doses of nifedipine GITS     and/or candesartan or placebo. These different regimens will be administered once a day and     will be assessed based on their blood pressure lowering effects (mean sitting diastolic blood     pressure) in subjects with mild to moderate essential hypertension.   "
151274|NCT01303770|"     Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million     people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive     impairment as a result of the disease including disturbances in memory, attention,     concentration, information processing, and executive functions such as problem solving, and     self-monitoring. MS-related cognitive impairments negatively affect many aspects of     functioning and independent participation in everyday life. Thus, PwMS who experience     cognitive impairments face a wide array of recurring barriers that pose grave challenges to     carrying out everyday activities while trying to maintain multiple life roles and as they     age.      Management of cognitive symptoms can be addressed through rehabilitation which has the     potential to reduce disability, prevent complications of the disease, and enhance     participation, independence, and quality of life. Considering the high frequency of cognitive     impairments in MS and their significant, complex impact on functioning and independence, it     is critical that cognitive interventions be an essential component of MS rehabilitation.      The overarching goal of this study is to develop and test a self-management, group-based     cognitive rehabilitation program designed specifically for PwMS.   "
151275|NCT01303757|"     The primary aim of the study is to examine insulin secretion as an effect modifier of the     efficacy of a low-fat vs. low-glycemic load diet for weight loss among overweight/obese young     adults in an 18-month, prospectively stratified, multi-center randomized controlled trial.   "
151276|NCT01303744|"     To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once     per day for up to 12 weeks to patients with mild cognitive impairment.   "
151277|NCT01303731|"     The objectives of this study is to test a combination of low dose local anesthetic     Bupivacaine diluted in patient's CSF with lipophilic opiate Fentanyl for optimal spinal     anesthesia during Cesarean Section. The dilution of Bupivacaine with CSF in our study would     result in effective spinal anesthesia with relatively limited motor block, quick recovery of     motor function and relatively long lasting analgesia. We expect lower incidence of side     effects with this combination than with convenient dose of Bupivacaine.   "
151278|NCT01303718|"     The purpose of the INOVATE-HF study is to demonstrate the long-term safety and efficacy of     vagus nerve stimulation with the CardioFit® system for the treatment of subjects with Heart     Failure.   "
151279|NCT01303705|"     This clinical trial will examine a novel combination of anti-OX40 to induce proliferation of     memory and effector T cells in conjunction with cyclophosphamide (CTX) and radiation to     induce tumor antigen release with the overall goal of promoting an immune response against     prostate cancer.   "
151280|NCT01303692|"     Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and     -plus anti-androgen agent   "
151281|NCT01303679|"     In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is     currently the standard treatment. In patients expressing hormone receptors, it was shown that     hormone therapy administered in maintenance after induction chemotherapy, could have a     benefit regarding the progression-free survival. The investigators make the hypothesis that     there would be interest to discontinue treatment with taxane after 4 months, and to begin     hormone therapy while continuing maintenance bevacizumab.      Exemestane was chosen because it has been shown potentially active in patients who progressed     after letrozole, anastrozole or tamoxifen.   "
151282|NCT01303666|"     Previous studies have indicated that patient expectations, beliefs and preferences may have     an impact on treatment outcomes. The KIVIS study was primarily designed to compare two     effective treatments for knee osteoarthritis (tidal irrigation (medical washout of the knee)     or intra-articular corticosteroid injection). At study entry any preference expressed by the     patient for each of the treatment interventions was recorded. This study assessed the effects     of two treatments given at a single time-point and hence the effects of patient preference     could be assessed independently of any compliance issues.   "
151284|NCT01303640|"     The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is     not inferior to the everolimus-eluting stent in terms of the rate of target-lesion     revascularization at 1-year and death or myocardial infarction at 3-year after stent     implantation in the real world clinical practice.   "
151285|NCT01303627|"     The effect of maintenance remifentanil infusion with target controlled infusion during     laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be     investigated.   "
151286|NCT01303614|"     The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain     during hysterosalpingography diagnostic practice.   "
151287|NCT01303601|"     Olanzapine may have some antidepressant properties and olanzapine monotherapy has been shown     efficacy in bipolar depressive episodes in retrospective studies. However, there has been no     prospective study about the monotherapy of olanzapine. The investigators conducted a     randomized, placebo-controlled study to test the efficacy of olanzapine monotherapy for     treatment of the depressed phase of bipolar disorder.   "
151288|NCT01303588|"     The objective of this study is to evaluate whether yoga or qigong therapy is effective in     treating low back pain in elderly patients compared to no therapy (waiting list control). The     secondary aim is to compare yoga and qigong.   "
151289|NCT01303575|"     This study will evaluate the effect of an American Indian/Alaska Native (AI/AN) adaptation of     the It's Your Game…Keep It Real (IYG) intervention, relative to a comparison condition on     sexual behavior outcomes and psychosocial variables for middle school aged youth (12 - 14     years old). The original IYG program was designed for students in Houston middle schools to     help students delay sexual initiation and if sexually active, use condoms and contraception.     The present study will adapt the existing IYG program for an AI/AN youth cohort; the original     IYG curriculum will be transferred into a web-based format and modified to incorporate     additional culturally-relevant components. The primary hypothesis to be tested is: (1)     students who receive the web-based curriculum will delay sexual activity relative to those     who receive standard care. The major dependent variable is the proportion of students     initiating sexual activity. Secondary hypotheses will examine the effect of the web-based     curriculum on specific types of sex and psychosocial variables related to sexual risk-taking     behavior. This project will also examine the effect of the intervention on the proportion of     students who are sexually active, number of times students engage in unprotected sexual     intercourse, and students' number of sexual partners.   "
151290|NCT01303562|"     The goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h)     bioavailability and pharmacokinetics of the major phytochemicals found whole barley and oats,     as well as their effects on selected measures of antioxidation, inflammation, insulin     sensitivity/glucose regulation, and vascular remodeling following challenge by an oral     glucose tolerance test (OGTT).   "
151291|NCT01303549|"     The study is a randomized, open-label safety study comparing the use of anidulafungin (200 mg     i.v. as initial dose and 100 mg/d i.v. in subsequent doses) vs liposomal amphotericin B (3     mg/kg/d i.v.) in hepatic transplant recipients who have high risk of fungal infection.   "
151292|NCT01303536|"     The aim of this study is to evaluate whether ondansetron augmentation to SSRI will improve     and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms     among obsessive compulsive disorder resistant patients.   "
151293|NCT01303523|"     The purpose of this study is to evaluate the impact of thromboembolic diseases and heparin     complications in patients with a lower limb trauma supported by physicians of mountain.   "
151294|NCT01303510|"     A study to assess whether the Northern Hemisphere 2008/2009 season influenza vaccine Inflexal     V fulfills the EMEA requirements for re-registration of influenza vaccines   "
151295|NCT01303497|"     Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma   "
151296|NCT01303484|"     The purpose of this study is to determine the effects of prebiotic B-GOS on the immune     function, metabolism and gut microbiota of elderly people   "
151297|NCT01303471|"     During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid     treatment is used for pain assessment.      The change in haemodynamic variables and clinical sign are evaluated during anesthesia for     pain assessment but these changes are not specific every time.      The main of this study is to investigate the relationship between calculated compartment     concentration of remifentanil (opioid) and the parameters from HRV (Heart Rate Variability)     and APV (Arterial Pressure Variability) before a standard noxious stimulation during general     anesthesia at calibrated hypnosis level.      Our hypothesis is that nociceptive stimulation would have reproductible effects on HRV, and     that these effects would be blunted or abolished by by adequate analgesia. The current study     is thus designed to analyse HRV and APV in patients with stable hypnosis, before and during     nociceptive surgical stimulation, at different levels of analgesia.   "
151298|NCT01303458|"     This research project is aimed to address low-income families' basic social needs (housing,     food, employment, education, childcare, utilities) within the context of pediatric primary     care. This project builds upon the PI's prior study at Hopkins which demonstrated a positive     impact of a similar intervention on pediatric residents' screening and referral to community     agencies. This study will specifically test whether a further strengthened     intervention--Basic Needs Surveillance (BNS) protocol-- can lead to greater maternal     enrollment in community resources and receipt of eligible benefits. In addition, we will     measure the intervention's impact on maternal well-being, and compliance with well-child care     (WCC) visits.      The project will take place at eight community health centers in the Greater Boston Area. The     centers will be randomized to either an intervention or control site. Mothers who bring their     infant in for a WCC visit from birth to 6 months will be eligible. They will be followed     until their child is one year of age. Study subjects will complete two self-administered     surveys (baseline, follow-up), and one brief telephone interview (when their infant is 9     months old). Pediatric providers will also be subjects; and will fill out a demographic     questionnaire at the time of enrollment.      The BNS intervention will consist of 4 components: 1) WE CARE survey which mothers will fill     out in the waiting room prior to their child's WCC visits; 2) Family Resource book containing     1-page information sheets on resources, that providers will have access to in exam rooms; 3)     a Community Resource Coordinator who will assist families link to available resources, and     update providers; 4) Training Session which will provide a 1 hr overview of the intervention     to providers.      Families attending the control health centers will receive standard of care. Enrolled mothers     will be offered the intervention at the end of the 12-month follow-up interview. When     follow-up data collection is complete, the PI will offer the control sites the opportunity to     implement the BNS protocol.   "
151299|NCT01303445|"     The objective of the current study is to investigate if a drug-drug interaction occurs with     the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of     dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition     (components of Aggrenox®) when administered every 12 hours at steady state.   "
151301|NCT01303419|"     Enrolled women will undergo a bilateral 2-view DE-CEDM examination after administration of an     iodinated contrast agent. Separate readers on-site will evaluate DE-CEDM+MX (standard     mammography) and CE-BMRI+MX to determine the extent of disease. An integrated reading of both     sets of images will be performed either by one or the two readers. DE-CEDM will not be used     to change the diagnosis. Lesions that are confirmed as suspicious by MX, CE-BMRI, or     follow-up breast ultrasound (US) will undergo biopsy. Truth about extent of disease will be     based on histologic analysis of surgical specimens along with follow-up MX 10-15 months after     the study exam. A randomized, blinded image evaluation will be done with 11 to 15 radiologist     readers to compare DE-CEDM+MX and CE-BMRI+MX for assessment of disease extent.   "
151355|NCT01302717|"     In this study, the investigators will examine whether left ventricular pacing is superior to     right ventricular apical pacing in preventing deterioration of left ventricular systolic     function and cardiac remodeling in patients with bradycardia with high risk for development     of pacing-induced heart failure.   "
151302|NCT01303406|"     This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to     further investigate the effects of idebenone in patients with Friedreich's ataxia.      The objective of the PROTI study is to establish whether patients can correctly determine     which treatment assignment (placebo or idebenone) they received during the randomised phase     of the trial, and identify any potential changes on symptoms or activities.   "
151303|NCT01303393|"     Aim The overall aim was to investigate information needs after surgery for colorectal cancer     and factors explaining information needs, both from the patients' perspective and the next of     kin's.   "
151304|NCT01303380|"     This pilot study is designed to evaluate the efficacy, the safety, and the pharmacokinetics     (PK) / pharmacodynamics (PD) of canakinumab treatment in patients with HIDS.   "
151305|NCT01303367|"     U.S. Food and Drug Administration (FDA) and other countries issue warnings on the off-label     use of antipsychotics in demented patients with behavioral and psychological symptoms of     dementia (BPSD) (FDA warning, 2003; 2005; 2008). There is a significant increase in mortality     rate by 1.6 fold due to cardiovascular events and aspiration pneumonia in the demented     patients received antipsychotics comparing to placebo group. However, the prescription rates     of antipsychotics in demented patients are still increased by 20% after several alerts in     Canada (Valiyeva et al., 2008).   "
151306|NCT01303354|"     The aim of this study is to assess the effectiveness and safety of dexamethasone for     transforaminal epidural steroid injection. A secondary aim of this study is to obtain data on     the lowest most effective dose of dexamethasone for this treatment and the effective duration     of effect.   "
151307|NCT01303341|"     This phase I trial studies the side effects and best dose of sorafenib tosylate when given     together with riluzole in treating patients with solid tumors or melanoma that has spread to     other places in the body and usually cannot be cured or controlled with treatment. Riluzole     may stop or slow the growth of tumor cells. Sorafenib tosylate may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving riluzole together with     sorafenib tosylate may kill more tumor cells.   "
151308|NCT01303328|"     The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel     containing an antiviral, administered directly on cervix exhibiting high grade squamous or     glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.   "
151309|NCT01303315|"     To assess the TANTALUS therapy in type 2 diabetic patients who can not tolerate GLP-1 agonist     due to unacceptable side effects; and to assess the TANTALUS therapy in type 2 diabetic     patients who do not sufficiently benefit from GLP-1 receptor agonist therapy   "
151310|NCT01303302|"     Evaluation of the safety and efficacy of gastric contractility modulation (GCM) stimulation     using the TANTALUS System in the improvement of glycemic control measured by changes in     HbA1c. Effects of GCM on weight loss and associated co-morbid conditions will also be     evaluated   "
151311|NCT01303289|"     The main objective of this trial is the clinical evaluation of a normoproteic diet, when this     diet is used for total enteral nutrition in geriatric people.      For 3 months,all the participants in the study will receive only tube feeding: The     experimental group will receive the commercial preparation to evaluate (T-Diet Plus ®,     Vegenat SA) and the control group will receive a standard diet (Jevity ®, Abbott     Laboratories).   "
151312|NCT01303276|"     Ranibizumab (Lucentis, Genentech) is an off-label drug used for the clinical treatment of     central retinal vein occlusion, which is one of the most common retinal vascular disorders.     Despite its clinical effectiveness, concerns remain regarding the systemic effects of the     drug and previous studies have noted retinal arteriolar vasoconstriction following a     ranibizumab injection. We aim to provide a physiological basis to these observations by     assessing retinal blood flow before and after the ranibizumab injections. Specifically, we     will assess the blood flow parameters (i.e. retinal vessel diameter, velocity & flow)     immediately before the first injection and post-injection over a follow-up continued     treatment period.   "
151313|NCT01303263|"     OBJECTIVE: To test a brief intervention designed to improve the cost-effectiveness of care     provided by medicine housestaff for hospitalized patients.      HYPOTHESIS: A brief intervention in which medicine residents receive itemized bills for     recent patients cared for by them, followed by a discussion on approaches to reducing     unnecessary inpatient costs, can result in significant cost reductions without adversely     affecting patient outcomes.   "
151314|NCT01303250|"     The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl     starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid     management will be given to optimize the stroke volume variation <= 12%.      The investigators hypothesize that patients in the intervention group will need less fluid     administration be optimal hemodynamic stabilized.   "
151315|NCT01303237|"     This prospective, observational, multicentre, post marketing surveillance study will collect     safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of     the Head and Neck (LA SCCHN) treated with Cetuximab and Radiotherapy (RT) based on the     locally approved label.   "
151316|NCT01303224|"     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial     aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor     antagonist Ibodutant in improving IBS-D symptoms.   "
151351|NCT01302769|"     The purpose of this study is to compare ear acupuncture plus standard of care versus standard     therapy (anti-inflammatory medications) in the reduction of pain, reduction in oral anti     inflammatory medication use, hours lost from work in acute sore throat.   "
151332|NCT01303016|"     The purpose of this research study is to better understand how to prevent malnutrition in     children under age 5 years in Intibuca, Honduras. A randomized community trial design was     used to implement a nutrition program, including a complementary nutrition supplement,     educational sessions, and growth and health monitoring integrated into the basic primary care     package, to participants living in communities in the intervention group. Participants living     in the control group communities will receive the nutrition supplement for one year following     the study.   "
151356|NCT01302704|"     The purpose of this study is to demonstrate if Proton Pump Inhibitors (PPI's) decrease blood     levels of 25-Hydroxyvitamin D (25-OH Vitamin D).   "
151317|NCT01303211|"     Major epidemics of meningococcal meningitis occur in countries of the African Sahel and     sub-Sahel every few years. Most of these epidemics are caused by meningococci belonging to     serogroup A. Until recently there has been no serogroup A conjugate vaccine available to     prevent epidemics in Africa because none of the major pharmaceutical companies wanted to     develop such a vaccine for commercial reasons. For this reason a public private partnership     was established in 2001, the Meningitis Vaccine Project (MVP), with support from the Bill and     Melinda Gates Foundation, to develop an affordable new serogroup A meningococcal conjugate     vaccine for Africa. The new vaccine, MenAfriVac™, received WHO pre-qualification in 2010 and     mass campaigns started in Burkina Faso, Mali and Niger in 2010. It is expected that full     coverage through mass vaccination campaigns will be achieved by the end of 2011 in these     three countries. A case-control study will be conducted in Mali and Niger during the epidemic     seasons of 2012 and 2013 to assess the efficacy of MenAfriVac™.   "
151318|NCT01303198|"     Part 1.Comparison of manual pressure titration in laboratory of sleep disorders with Autoset     T APAP device from Resmed. Hypothesis: There is no difference in efficiency between manual     and automatical titration.      Part 2. Comparison of CPAP and APAP therapy in the home while 3 month by Questionaire and     device data.      Hypothesis: There is a difference in compliance and efficiency between CPAP and APAP mode.   "
151319|NCT01303185|"     The treatment options for nail psoriasis have been limited, and the management of nail     psoriasis has been challenging for physicians.To evaluate the effect of pulsed dye laser     (PDL) in the treatment of nail psoriasis.   "
151320|NCT01303172|"     To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in     combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL),     clinical signs and symptoms of disease, selected markers of tumour burden and immunological     status, and disease outcome.   "
151321|NCT01303159|"     The purpose of this study is to assess safety and ability of the endoscopic bipolar     radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of     cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat     the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes     coagulated and this may delay tumour growth and the time before the stent lumen becomes     blocked. Thereby, allowing increased periods between the need for intervention and further     stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open     longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.   "
151322|NCT01303146|"     There is currently no effective treatment for late infantile MLD once clinical symptoms are     evident. METAZYM is a recombinant human arylsulfatase A developed for an intravenous ERT for     the treatment of late infantile MLD. The overall objective of this study is to evaluate the     efficacy and safety of intravenous rhASA treatment in a patient with late infantile MLD who     had previously received hematopoietic stem cell transplantation (HCT).   "
151323|NCT01303133|"     The primary objective of this study is to assess the presence of amyloid in     non-demented/functionally stable adults with DS as a function of age, dividing the sample     into amyloid-positive and amyloid-negative groups. We will also obtain baseline cognitive     measures across a range of areas that are often affected by AD.   "
151324|NCT01303120|"     The aim of this study is to compare the efficacy of the analgesic effect of the preoperative     femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral     cutaneous nerve blocks in patients after TKA in the immediate postoperative period.   "
151325|NCT01303107|"     The purpose of this study is to determine if the mixture of enantiomers of bupivacaine     (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the     racemic mixture of enantiomers of bupivacaine (bupivacaine S50:R50).   "
151326|NCT01303094|"     This randomization discontinuation trial will allow for concomitant evaluation of the     following:        -  Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle        -  Side effects and benefits of a drug holiday   "
151327|NCT01303081|"     Financial incentives may be more effective than other approaches to smoking cessation, but     research is needed to identify the optimal structures of incentives. The investigators will     conduct a pilot randomized trial comparing different incentive structures for smoking     cessation. Collaborating with Walgreens leadership, the investigators will enroll their     employees in this RCT using the investigators new web-based research infrastructure (called     the Way to Health platform, and approved as a Prime protocol by the IRB as reference #     811860).      Hypothesis: providing patients with financial incentives can promote healthier behaviors     (e.g.: quit smoking).   "
151328|NCT01303068|"     The purpose of this study is to determine if inhaled urea can be used to detect the presence     of Pseudomonas Aeruginosa in the lungs   "
151329|NCT01303055|"     It is reported that pancreatic beta cell function is already declined at pre-diabetic stage,     impaired glucose tolerance (IGT). It has not been clarified whether inhibitors of the     dipeptidyl peptidase IV enzyme (DPP-IV inhibitors) improve beta cell function on human     pancreas, however, if efficacy is ensured, they may become the first medicine to be chosen     for treatments of type 2 diabetes and IGT.      In this trial, a DPP-IV inhibitor, Alogliptin, or Metformin are given to diabetic patients     whose HbA1c level is below 7.9%. Oral glucose tolerance test (OGTT) will be conducted before,     a year after, and two years after the beginning of the trial and beta cell function will be     evaluated.   "
151330|NCT01303042|"     Insulin therapy with lispro mix 50/50 t.i.d. is a treatment with a single insulin device. The     management is comparatively simple and easy, but the curative effect is promising. It is also     reported that noninferiority has been observed between basal/bolus therapy (BBT) and prandial     premixed therapy (PPT, lispro mix 50/50 t.i.d.).      The purpose of this study is to evaluate whether change of insulin therapy from BBT     (long-acting insulin at bedtime plus mealtime rapid-acting insulin) or analog insulin therapy     t.i.d. (including therapies with aspart mix 70/30 and lispro mix 75/25) to lispro mix 50/50     t.i.d. improves glycemic control of patients with type 2 diabetes mellitus.   "
151331|NCT01303029|"     The purpose of the study is to evaluate the efficacy of the combination of     gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in patients with metastatic     pancreatic cancer.   "
151919|NCT01295242|"     The purpose of this study is to determine rates of oral and genital human papillomavirus     (HPV) infections, and look at risk factors for HPV infection in healthy mid-adult women.   "
151333|NCT01303003|"     Transversus abdominis plane (TAP) blocks are increasingly being performed after abdominal     surgery to provide post operative analgesia. Dexamethasone has demonstrated an ability to     prolong the effective duration of analgesia in several different peripheral nerve blocks. The     study will examine, in a blinded, prospective and randomized fashion, whether the addition of     dexamethasone to TAP blocks similarly prolongs blockade and pain relief. The study will     compare local anesthetic with and without the addition of dexamethasone in the TAP block.   "
151334|NCT01302990|"     This is a Phase 1, randomized, double-blind, active- and placebo-controlled, multicenter,     dose-ranging study to evaluate the safety, tolerability and Immunogenicity of a single     non-adjuvanted dose of the H1 VLP Influenza vaccine in healthy adults 18-49 years of age.   "
151335|NCT01302977|"     The neonatal mortality rate in cases with severe isolated congenital diaphragmatic hernia is     higher than 90% due to severe pulmonary hypoplasia. Many studies have suggested that fetal     tracheal occlusion may increase lung volumes and therefore reducing the risk for severe     pulmonary hypoplasia and by consequence the risk for neonatal death.      The main objective of the present study is to evaluate if fetal tracheal occlusion improves     survival rate in those cases that are followed in our hospital, by conducing a randomized     trial.   "
151336|NCT01302964|"     This study will determine the effectiveness of mirtazapine in reducing anxiety in children     with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.   "
151337|NCT01302951|"     The aim of the study is to provide data on the pharmacokinetics (PK) of moxifloxacin (MXF) in     serum and liver tissue of patients undergoing liver resection due to primary or secondary     tumor of the liver.   "
151338|NCT01302938|"     To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in     subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative     web-based trial design   "
151339|NCT01302925|"     The purpose of this phase 1 trial is to investigate the local tolerability on the finger     following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3     consecutive days.   "
151340|NCT01302912|"     Imaging techniques have considerably improved over the last decades and ocular adnexal     lymphomas (OALs) nowadays can be detected. As major advances in immunophenotyping and     molecular diagnostics in histology have been achieved offering an accurate diagnosis, the     investigators would like to introduce that surgical biopsy of an orbital lymphoma becomes     crucial for the possibility of a correct diagnosis and proper treatment. As radiotherapy     accomplished great preciseness as well and OALs respond excellently to radiation, this     therapy should be the treatment of choice in local defined lymphomas instead of blind     treatment with steroids. Radiation results in great local control rates of 85% to 100%        -  Trial with surgical intervention   "
151341|NCT01302899|"     The study is designed to primarily assess the effect of aliskiren on albuminuria in patients     with non-diabetic nephropathy when treated with ramipril and volume intervention.   "
151342|NCT01302886|"     This study will assess the antimyeloma effects of BHQ880A in patients with smoldering     multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be     administered every 28 days in previously untreated patients. Disease assessments will be     performed monthly and effects on bone metabolism will be assessed by measurement of serum and     urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of     BHQ880 as a single agent and following multiple doses will be obtained.   "
151343|NCT01302873|"     This study will assess the efficacy of a two week treatment with BGG492 in patients with     chronic subjective Tinnitus.   "
151344|NCT01302860|"     This trial will assess the safety, efficacy and tolerability of ACZ885 in patients aged 4     years and younger with cryopyrin associated periodic syndromes (CAPS)   "
151345|NCT01302847|"     Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study will test     the safety of and immune response to DTG in HIV-1 infected infants, children, and     adolescents.   "
151346|NCT01302834|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.     Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. It is not yet known whether radiation therapy is more     effective with cisplatin or cetuximab in treating oropharyngeal cancer.      PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to     see how well it works in treating patients with oropharyngeal cancer.   "
151347|NCT01302821|"     The purpose of this research project is to create images of where and how the amino acid (the     building blocks of proteins)Tryptophan is processed in normal and abnormal tissue in the     patient's body. Tryptophan is a normal building block of proteins in the body. Sometimes in     the case of cancer and other diseases, Tryptophan is processed abnormally, and possible     treatments for this abnormality are of great interest because of the potential to improve     cancer care.   "
151348|NCT01302808|"     RATIONALE: Romidepsin and erlotinib hydrochloride may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.      PURPOSE: This phase I/II trial is studying the side effects and best dose of romidepsin when     given together with erlotinib hydrochloride and to see how well they work in treating     patients with stage III or stage IV non-small cell lung cancer.   "
151349|NCT01302795|"     This study is a prospective open label evaluation of Canakinumab (Ilaris) for treatment of     subjects with pyoderma gangrenosum.   "
151350|NCT01302782|"     The purpose of this research study is to observe whether there is a change in blood glucose     levels in response to a 2 hour oral glucose tolerance tests (OGTT) during acute normobaric     hypoxia (short term low oxygen levels at normal ambient air pressure).   "
151352|NCT01302756|"     The purpose of this study is to determine if higher-than usual doses of daily folic acid has     an effect on the rate of gestational diabetes mellitus (GDM) or gestational hypertension in     pregnant women while determining status of folic acid, vitamin B12, homocysteine and vitamin     D in pregnancy.   "
151353|NCT01302743|"     The purpose of this study is to assess whether Cinnamon bark or water-soluble cinnamon is an     effective nutraceutical for the initial treatment of diabetes when compared to standard     therapy of Metformin.   "
151357|NCT01302691|"     This study is being done to evaluate the efficacy, safety, and tolerability of losartan     potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5)     (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean     trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5     in Japanese participants with essential hypertension who are not adequately controlled     following an 8-week treatment with filter period study drug (L50+A5).   "
151358|NCT01302652|"     The purpose of this research study is to study the effects of growth hormone (GH) replacement     on the heart. The investigators will study these effects in people who have been cured of     acromegaly and then have developed growth hormone deficiency (GHD, not enough growth     hormone).   "
151359|NCT01302639|"     There are strong indications that (combinations of) polyphenols may be attractive candidates     in the prevention of the metabolic syndrome and diabetes through modulation of pathways of     fatty acid metabolism and mitochondrial function. We hypothesize that the combination of     specific polyphenols, with partly distinct mechanisms of action, may have physiologically     significant effects on fat oxidation through additive or synergistic effects, thereby     improving body composition, insulin sensitivity and preventing type 2 diabetes. The following     objective will be addressed in the current study:      (1) to test short term (3 day) effects of combinations of polyphenols (supplements of EGCG     either in combination with resveratrol or with resveratrol and genistein) to affect systemic     lipolysis and fat oxidation during overnight fasted conditions and after ingestion of a high     fat meal in overweight subjects   "
151360|NCT01302626|"     Aim of the study: The main aim is to collect data of patients with lung cancer, and to     perform different analyses on this data. The data contains information on patient and tumor     characteristics, imaging, and treatment characteristics. With this data it is possible to     improve and validate the predictive model for survival and long term toxicity in lung cancer     by multicentric prospective data collection. The long term aim, beyond this specific study,     is to build a Decision Support System based on the predictive models validated in this study.      Hypothesis: The general hypothesis is that we get a better prediction in terms of AUC (area     under the curve) of survival and long term toxicity when we combine multifactorial variables.     These variables consist of information from clinical data, imaging data, data related to     treatment type and treatment quality.   "
151361|NCT01302613|"     The primary objective of the pilot portion of this study is to establish the safety and     tolerability of an extended treatment break period in patients who have undergone neoadjuvant     chemoradiotherapy as well as use of systemic therapy during this break.   "
151362|NCT01302600|"     Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant patients     aged 3-25 years   "
151363|NCT01302587|"     This study is evaluating the effectiveness of a dose counter for an inhaler device used to     deliver medication to people diagnosed with asthma or COPD.   "
151364|NCT01302574|"     The purpose of this study is to determine the functional significance of sweet taste     receptors in the secretion of gastrointestinal (GI) satiation peptides by using a specific     sweet taste receptor antagonist to block sweet taste perception in the gastrointestinal     tract.   "
151365|NCT01302561|"     The purpose of this research study is to determine whether a functional fiber,     galactooligosaccharide, can help maintain immune strength and digestive health in free-living     older adults. It is hypothesized that older adults consuming the fiber daily for 24 weeks     over cold and flu season will have more healthy days due to a proliferation of beneficial     bacteria within the colon which alters cytokine production and enhances natural killer cell     function. Immune and gastrointestinal health will be evaluated via daily questionnaires     obtained from 80 participants and from the collection of blood and fecal samples.   "
151366|NCT01302548|"     The purpose of this study is to determine if wound cleansing and irrigation using the     IRRISEPT Chlorhexidine Gluconate(CHG)solution, applying a given volume with a pressurized     stream, will improve the outcome for infected abscesses in patients that present in the     emergency department.   "
151367|NCT01302535|"     The purpose of this study is to determine the effects of yoga on blood pressure and quality     of life in patients in primary health care diagnosed with hypertension within the last year.     Another purpose is to examine whether the possible effect on blood pressure differs if     patients practice yoga in a group lead by a yoga-trainer or receive a few yoga-exercises from     their doctor to be practiced individually at home.   "
151386|NCT01302288|"     Achalasia is a primary esophageal motility disorder where the lower esophageal sphincter     fails to relax in response to swallowing with no well understood underlying cause. Surgical     myotomy represents an appropriate therapeutic option. The purpose of this study is to     evaluate flexible endoscopic myotomy, a novel therapeutic approach to overcome the need for     invasive surgery.   "
151387|NCT01302275|"     The purpose of this trial is to determine if the effect of oxcarbazepine on chronic     peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine     mainly relieve pain in patients with irritable nerves.   "
151933|NCT01295060|"     This is a long term study to evaluate the safety, tolerability and efficacy of an Octreotide     Implant in patients that were previously treated with an Octreotide implant.   "
151368|NCT01302522|"     Spinal cord injury (SCI) is a disabling condition that impairs fundamental abilities, such as     ambulation, respiration, and toileting. Compromised ambulation is a common, devastating     impairment following SCI. Yet, despite the fundamental desire to walk, no conventional     rehabilitation regimen reliably improves ambulation after SCI, and many SCI patients do not     have reliable transportation access, decreasing community integration and access to needed     services, including rehabilitation. Little is also known about the subtle neural events that     may predict motor recovery in incomplete SCI patients. This study will test a novel, safe,     easy to implement technique that has shown promise in improving gait in incomplete SCI     patients. The investigators expect that this study will confirm the efficacy of this     technique, by showing that it increases the speed and efficiency of walking. This outcome is     expected to produce a therapy that improves outcomes and health, and reduces care costs, for     community dwelling patients with incomplete SCI.   "
151660|NCT01298687|"     The purpose of this study is to compare the incremental dosing of travoprost ophthalmic     solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in     patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).   "
151369|NCT01302509|"     CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status     of cancer patients, leading to nutritional support. The aim was to study enteral nutrition     indications, as well as its compliance and the impact on nutritional status.      DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year     followed during anticancer therapy were included from January 2002 to January 2004. They     received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a     weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was     observed, tube feeding with the same supplement (TFR) was indicated.   "
151370|NCT01302496|"     The CTLA-4 blocking monoclonal antibody ipilimumab (MDX-010, BMS-734016), has demonstrated     anti-tumor activity in a subgroup of patients with Stage III (unresectable) or Stage IV     melanoma (measurable per modified WHO criteria), who have received prior treatment with any     regimen (non-experimental or experimental), except a CD-137 agonist or a CTLA4 inhibitor or     agonist and relapsed, failed to respond (CR or PR) or did not tolerate that regimen (Wolchok,     Neyns et al. 2009; O'Day, Maio et al. 2010). Ipilimumab exerts its therapeutic effect     presumably by activating T-lymphocytes that infiltrate the tumor mass to destroy the     malignant cells by mechanisms of cytotoxic cellular interaction. Autologous TriMix-DC vaccine     can induce a T-cell repertoire that recognizes in a HLA-restricted way the melanoma     associated antigens MAGE-A3, MAGE-C2, tyrosinase and gp100. Administration of ipilimumab     together with TriMix-DC vaccine therapy may be a more effective treatment for patients with     advanced melanoma as compared to either modality alone.   "
151371|NCT01302483|"     The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3%     tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental     procedures.   "
151372|NCT01302470|"     The primary goal of this study is to evaluate the use of robotically -assisted device leads     as a primary strategy for heart resynchronization.This trials aims to compare transvenous     lead placement with robotic lead placement for cardiac resynchronization therapy.   "
151373|NCT01302457|"     There have been multiple articles done regarding oral hygiene on patients in burn and     intensive care patients. All articles agree the need for good oral hygiene in these special     needs patients. They also note that more research needs to be done on this subject, yet have     no direction of how to proceed in this research. Currently, no research has been done on the     burn/intensive care patient to see if there is a difference form the non-hospitalized patient     which oral hygiene protocol is based on.   "
151374|NCT01302444|"     Objectives: To test whether the combined administration of the medications treprostinil(a     prostacycline therapy), and tadalafil(a PDE-5 [ phosphodiesterase type 5]Inhibitor therapy)     is better than the administration of treprostinil alone. This treatment would be offered to     newly diagnosed patients with pulmonary arterial hypertension who are on no treatment for     this disease and are deemed candidates for the medication treprostinil by their physician.     The combination therapy will be compared to single therapy with only treprostinil in a     double-blind manner.      Current therapy is to begin one treatment, either a PDE5 inhibitor or a prostacycline,     depending on the severity of the patient's PAH (pulmonary arterial hypertension) disease and     add additional therapies as deterioration occurs. This treatment could add two agents     initially.      Secondary objectives are: To improve pulmonary arterial pressures as measured through a     cardiac echocardiogram, improve the subject's 6minute walk distance, delaying the time to     clinical worsening, and lowering plasma BNP levels.      Research Procedures: To begin the administration of both treatments at the same time.      Time period is 16 weeks with a one- year follow-up. Cardiac Echocardiograms, clinic physician     exams, and lab work will be followed. Subjects will be between the ages of 18 - 75.   "
151375|NCT01302431|"     The primary aim of this study is to determine if a manual based telephone intervention     support service for people who support people with Multiple Sclerosis (PwMS), initiated by     nurse specialists who provide care to PwMS, has a positive impact on the lives of PwMS and     their support persons. For support persons this impact is determined by measurable support     person/carer self-efficacy and preparedness to care, burden, quality of life, service     utilization and satisfaction with the support service. For PwMS this is determined by their     qualitative experience of the type of care they receive from their carer. A secondary aim is     to determine the possible economic benefits of the introduction of such an intervention     nationally. A support person is the person nominated by the PwMS as the person who provides     the most support or physical assistance to a person with MS who is not a paid service     provider.   "
151388|NCT01302262|"     This study will evaluate effects of smoking on the dopaminergic system by using PET     tomography with new radioligand, [11C]-(+)-PHNO. Our primary hypothesis is that smoking a     cigarette will produce dopamine release and this release can be measured using PET imaging     and the [11C]-(+)-PHNO radiotracer. The secondary hypothesis is that this smoking induced     dopamine release will be correlated with subjective craving and anxiety ratings.   "
151389|NCT01302249|"     This is a double-masked, randomized, multi-center, active-controlled, crossover comparison of     the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular     pressure (IOP).   "
151390|NCT01302236|"     The purpose of this study is to determine whether eplerenone is effective in the treatment of     blood pressure, heart function, renal function in elderly hypertensive stage1     (eGFR>=90ml/min/1.73m2) and stage2 (eGFR 60-89ml/min/1.73m2) chronic kidney disease (CKD)     patients.   "
151431|NCT01301703|"     Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent     B. pertussis infection between 8%--26% have been reported among adults with cough illness of     at least 5 days duration who sought medical care. The CDC recommends vaccinating patients     aged 15 to 64 years old, once in 10 years. Although acellular vaccines such as BOOSTRIX have     been evaluated in healthy population, the safety and efficacy of this vaccine in patients     suffering from rheumatic diseases have not been established.      Study population : 50 Rheumatoid Arthritis (RA) patients and 5 healthy controls      Evaluation : the evaluation will be performed on week 0 and 4-6 weeks later. In terms of     safety, the patients will be evaluated according to the Disease Activity Index (DAS). Blood     will be drawn at each visit at tested for humoral response to tetanus and pertussis.   "
151661|NCT01298674|"     This is an epidemiological study to assess the the prevalence of Age-Related Macular (ARM)     Degeneration in Portugal.   "
151376|NCT01302418|"     The study will be conducted using nasopharyngeal swab specimens collected prospectively from     individuals suspected of having the signs and symptoms of an acute respiratory tract     infection caused by a respiratory virus. A series of standard viral culture tests validated     for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed     Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the     performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II     Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot     will be tested in real-time using the assigned viral culture reference methods; (b) one     aliquot will be used to extract nucleic acid in real-time for investigational testing; (c)     one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference     laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent     follow-up by the reference laboratory (e.g., bi-directional sequencing of positive     specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The     extracted nucleic acid generated from the second aliquot (i.e., b above) will be split and     subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced     Panel test.   "
151377|NCT01302405|"     PRI-724 is a new investigational drug being studied to treat subjects with cancer who have     advanced solid tumors. PRI-724 is thought to work by blocking the Wnt signaling pathway that     cancer cells need to grow and spread(metastasize).      Phase Ia: Patient cohorts with solid tumor malignancies will be treated with escalating doses     (per cohort) of PRI-724 in order to identify the MTD of this single-agent regimen. PRI-724     dosing is to start at 40 mg/m2/day, CIV infusion over 24 hours × 7 days.      Phase Ib: This phase is to begin upon identification of the MTD in Phase 1a. Patient cohorts     with CRC will be treated with escalating doses (per cohort) of PRI-724 administered in     combination with a modified regimen of FOLFOX6 (mFOLFOX 6, standardized doses and schedule)     in order to identify the MTD of this combined regimen. Up to 2 dose levels of PRI-724 are to     be examined (640 and 905 mg/m2/day, CIV infusion over 24 hours × 7 days), with potential to     evaluate a previously unexamined intermediate dose, if indicated, to more fully characterize     tolerability. The MTD cohort (or maximum dose to be studied) will be expanded up to 12     patients.   "
151378|NCT01302392|"     This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens     for subjects with multiple myeloma who have received all available approved treatment options     and may therefore be considered candidates for palliative care.   "
151379|NCT01302379|"     This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle     intervention and metformin (a drug used to treat diabetes) to investigate how these     treatments, alone or in combination, affect biomarkers associated with breast cancer     survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast     cancer survivors. After completing the screening process and baseline measures, participants     will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle     intervention and placebo, or (4) lifestyle intervention and metformin. The interventions will     last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and     6 months.   "
151380|NCT01302366|"     This study proposes to determine the clinical activity of this agent in patients with     asymptomatic multiple myeloma. It is believed that TBL12 will help delay the onset of active     multiple myeloma, with very few-if any- side effects.   "
151381|NCT01302353|"     In this trial, our primary goal is to investigate the safety of intravenous infusion of     emulsified isoflurane. In order to protect volunteers, the investigators adopt the modified     Fibonacci dose-escalation, starting from a very low dose which is derived from the 1/600 of     acute LD50 in pre-clinic study. The trial will be terminated if half of volunteers develop     severe adverse event in any dose group or any volunteer develop fatal adverse event in any     group.   "
151382|NCT01302340|"     Dementia is a common chronic condition, with predicted increasing prevalence. Nearly all     patients with dementia will experience neuropsychiatric symptoms (NPS). This causes     significant burden for the individual patients and their caregivers. Current treatment has     only modest efficacy and important side-effects. Formulations with Δ9-tetrahydrocannabinol     (THC), the psycho-active compound of cannabis, are currently being registered for spasms in     multiple sclerosis and other diseases, and may have beneficial effects on NPS.   "
151383|NCT01302327|"     Wolfram syndrome, also referred to as DIDMOAD (diabetes insipidus, diabetes mellitus, optic     atrophy and deafness) is a genetic syndrome characterized by beta-cell dysfunction and     apoptosis leading to diabetes, neurodegeneration and psychiatric illness. Accumulating     evidence indicates that beta-cell failure and neuronal cell dysfunction in Wolfram's syndrome     results from a high level of ER stress in affected cells. The current treatment of Wolfram     syndrome is insulin, which fails to prevent the progression of beta-cell failure.      Several studies showed that GLP-1 analogs are very effective in protecting beta-cells from ER     stress. Herein, the investigators suggest studying the impact of GLP-1 analogs in the     treatment of patients with Wolfram syndrome.      The investigators will Study the effects of GLP-1 analog (Exanatide) on beta-cell function     and glycemic control of patients with Wolfram syndrome. Evaluation of beta cell function will     be done by performing meal test and IVGTT test before starting GLP-1 therapy, and after 3     month of treatment.   "
151384|NCT01302314|"     This study will examine the effects of a theoretically grounded and manualized cognitive     rehabilitation program on patients with Spina Bifida (SB). SB is often associated with     deficit in higher order control over cognition, emotion and behaviour; which is typically     referred to as executive functions. The present study will examine the efficacy of Goal     Management Training (GMT) in patients with SB that experience executive difficulties. It is     expected that GMT will have a favourable effect on cognitive executive functioning,     psychological and health related factors.   "
151385|NCT01302301|"     Achalasia and esophageal spasm are primary esophageal motility disorders where the lower     esophageal sphincter fails to relax in response to swallowing with no well understood     underlying cause. Surgical myotomy represents an appropriate therapeutic option. The purpose     of this study is to evaluate flexible endoscopic myotomy a novel therapeutic approach to     overcome the need for invasive surgery.   "
151428|NCT01301742|"     To investigate the relative bioavailability of BI 10773 following coadministration with 600     mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.   "
151391|NCT01302223|"     KERATINOCYTE GROWTH FACTOR AND CYTOKINES IN SKIN BURNS.      INTRODUCTION: Intense inflammatory responses are activated by burns that affect a large total     body surface area. Changes in plasma levels of cytokines after burns occur before metabolic     abnormalities unsettle the patient. So it may be possible to develop therapeutic     interventions that may attenuate the acute inflammatory response by decreasing the expression     of these cytokines. The importance of growth factors in the healing process was demonstrated     in cultured keratinocytes and fibroblasts. The keratinocyte growth factor (KGF) is a growth     factor active in the repair of wounds, being the most potent stimulator of mitotic cells.      PURPOSE: To assess the level of keratinocyte growth factor (KGF) and IL-1ß, IL-6, IL-8,     IL-10, IL-12 and TNF-alfa of patients with burns produced by cultured primary dermal     fibroblasts and the gene expression.      METHODS: 10 patients will be include (05 patients in the study group and 05 patients in the     control group) admitted to the Burns Care Unit of the Discipline of Plastic Surgery, Federal     University of São Paulo (UNIFESP) between 25% and 50% of total body surface area (TBSA), deep     second-degree or third degree, with need to perform surgical debridement. The control group     will be constituted by patients with less than 5% of TBSA, deep second-degree or third     degree, with need to perform surgical debridement. The authors will evaluate the levels of     IL-1ß, IL-6, IL-8, IL-10, IL-12p70 and tumor necrosis factor alpha (TNF-alfa) in samples of     the culture media of primary dermal fibroblasts of patients selected using flow cytometry.     The level of keratinocyte growth factor (KGF), in the same samples will be evaluated by     ELISA. The keratinocyte growth factor (KGF) and TNF-alfa gene expression will be evaluated in     the culture of primary dermal fibroblasts from the same patients. The gene expression of KGF     and cytokines will be done by qRT-PCR and RT-PCR array. The experiments will be done in     duplicate.   "
151392|NCT01302210|"     Our hypothesis for the DERAIL MRSA program is that one can safely remove the colonization     risk from nearly all residents (patients) in a way that does not interfere with the desired     life-style for persons in these facilities and thereby reduce the risk of infection and lower     the cost of care by avoiding preventable disease.   "
151393|NCT01302197|"     Stroke, a leading cause of disability in the aging population, increases the risk for     diabetes, subsequent stroke recurrence, and cardiovascular disease complications. The     downsizing of private and federal health care resources, along with the anticipated increase     in stroke rates as our population ages, mandate that alternative strategies be developed to     reduce the public health burden of stroke. This pilot study may facilitate our knowledge of     the timing of paretic leg muscle atrophy, fiber type shift, and the progression of worsening     of glucose tolerance after stroke. Knowledge of the skeletal muscle changes occurring in the     sub-acute stroke period is essential to create new guidelines incorporating exercise     rehabilitation, much like cardiac rehabilitation, in order to facilitate and improve the     health care of veteran stroke survivors.   "
151394|NCT01302184|"     Gait rehabilitation with treadmill has been reported to be useful in patients with     Parkinson's disease. In the last years, interest in robotic devices for gait training has     grew up for patients with different neurological disorders, since they minimize demands on     physical therapists and may provide a more reliable and constant treatment.      The aim of this study is to evaluate if robotic gait training with Lokomat® can improve     walking more than conventional gait training with treadmill in patients affected by     Parkinson's disease.   "
151395|NCT01302171|"     A randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary     injection of progenitor cells compared to placebo injection in patients with Dilated     Cardiomyopathy who have been pre-treated with G-CSF (Granocyte™) injections for 5 days, and     patients treated with a 5 day course of G-CSF (Granocyte™) injection only compared to placebo     injection   "
151396|NCT01302158|"     A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of     glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics,     safety and pharmacodynamics of ASP1941 (Part B).   "
151397|NCT01302145|"     A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when     ASP1941 is administered as add-on therapy to metformin.   "
151398|NCT01302132|"     This study investigates the pharmacokinetics, in particular the routes and extent of     metabolism and excretion, of ASP1941 after a single oral dose.   "
151399|NCT01302119|"     The purpose of this study is to determine whether AN2690 topical solution is a safe and     effective treatment for onychomycosis of the toenail.   "
151400|NCT01302106|"     This is an interventional, multicenter, open label, phase II study designed to evaluate the     safety and efficacy of Clofarabine in combination with low dose Cytarabine in untreated     patients with poor risk of Myelodisplastic Syndromes.   "
151401|NCT01302093|"     This study is designed to assess bioequivalence between two products used for treatment of     acute diarrhea.   "
151402|NCT01302080|"     To evaluate the long-term impact of treatment with sertraline on aspects of cognitive,     emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16     years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive     compulsive disorder.   "
151403|NCT01302067|"     This study is designed to confirm if 8mg of fesoterodine is more effective in reducing     overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to     assess if the higher dose reduces the overall effect of overactive bladder on the subject's     daily life more than the lower dose. The study also assesses the side effects and safety of     the two doses.   "
151404|NCT01302054|"     Patients with overactive bladder are often treated with tolterodine, a medication that helps     relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes     patients do not have a satisfactory response, and may benefit from trying an alternative oral     medicine. Fesoterodine is related to tolterodine by producing the same active substance that     acts on the bladder, but potentially at higher and more effective levels. So, a patient who     has a poor response to tolterodine may still obtain a good response to fesoterodine. This     study will help find out if this is what happens.   "
151405|NCT01302041|"     To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with     prostate cancer.   "
151406|NCT01302028|"     A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes     Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients     with normal renal function and healthy volunteers.   "
151407|NCT01302015|"     The purpose of this study is to investigate the efficacy and safety of autologous     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with     Buerger's disease.   "
151408|NCT01302002|"     The study will test metformin in patients with early breast cancer. Blood and tissue will be     collected before and after the use of metformin.   "
151618|NCT01299233|"     To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real     Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg     Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle     scan-measurements.        -  Trial with medical device   "
151409|NCT01301989|"     Inadequate sleep is a major health problem of childhood that often fails to receive attention     until significant neurobehavioral and other health problems are noted. Although adequate     sleep is essential for normal growth and brain development, studies show that children from     minority and economically disadvantaged families are more likely to experience shorter sleep     times and more sleep fragmentation compared to their Caucasian and economically advantaged     counterparts. As a result, they are disproportionately affected by the adverse health and     quality of life consequences of poor sleep. There are currently no intervention studies to     the investigators knowledge aimed at addressing sleep disparities by improving sleep duration     and sleep hygiene in early school-aged children from minority populations. This study seeks     to close the 'sleep gap' that exists between the sleep duration of minority school-aged     children and that of their non-minority peers. An interdisciplinary team of researchers and     clinicians from Columbia University's Pediatric Lung and Sleep Disorders Center, School of     Public Health, Psychiatry Department, and two outpatient clinic systems affiliated with     Columbia are collaborating to reduce sleep disparities by improving sleep duration in a group     of 5-6 year old minority children. The primary goal of this study is to evaluate the efficacy     of a tailored, interactive, educational and behavioral intervention that utilizes trained     sleep counselors to assist parents in improving their children's sleep hygiene and reducing     risk factors for poor sleep, thereby increasing sleep duration over a 12-month period in a     randomized controlled trial of children identified with sleep problems (Aim 1). The     investigators will screen 375 parents of 5-6 year old children from 5 primary care clinics to     identify children with and without sleep problems and enroll 90 of the 375 children screened     who have sleep problems in a randomized controlled trial of an in-home sleep intervention.     Using an initial home assessment, baseline actigraphy data, sleep logs recorded by parents,     and information regarding risk factors for poor sleep collected from each family during     screening, the investigators will work with intervention parents to develop a personalized     sleep plan for their children. The investigators will evaluate the effect of the intervention     on: a) nightly sleep duration; b) neurocognitive function; and c) behavioral disorders.   "
151410|NCT01301976|"     The purpose of this study is to determine the reason patients are deficient in nutrients     intake such as antioxidants vitamins.   "
151411|NCT01301963|"     This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating     patients with multiple myeloma (MM) previously treated with lenalidomide. Giving     colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the     patient's bone marrow to the blood so they can be collected and stored   "
151412|NCT01301950|"     This study is designed to compare the surgical efficiency of TruMatch® Personalized Solutions     surgical technique compared to conventional surgical technique. Specifically, the purpose of     this study is to collect time data to enhance the existing economic model.   "
151413|NCT01301937|"     Phase III clinical trial for mucosal or mucocutaneous leishmaniasis. Equivalence between the     standard and alternative schemes with meglumine antimoniate has begun in October 2008 at the     Laboratory of Leishmaniasis Surveillance at Evandro Chagas Clinical Research Institute     (IPEC), FIOCRUZ, aiming to compare efficacy and safety of the standard recommended schedule     with an alternative regimen of meglumine antimoniate (MA) in the treatment of mucosal or     mucocutaneous leishmaniasis (ML or MCL)). It is a study with blind evaluation by the doctors     and the responsible for statistical analysis. Patients diagnosed with Ml or MCL, eligible for     the trial, are randomly allocated into one of the schemes with meglumine antimoniate and     monitored before, during and after it. There is no single regimen applicable to all forms of     leishmaniasis around the world. Therapeutic regimens applied to treat people living in other     geographic areas result in mixed outcomes. Ideally, the most appropriate regimens should be     established for each endemic area, based on its efficacy, toxicity, difficulties of     administration and cost. Given the problems and limitations of the use of pentavalent     antimonials at 20 mg / kg / day, a less toxic alternative regimen with 5mg/kg/day, continuous     up to the cure deserves to be better evaluated. Treatment must lead to the healing of mucosal     lesions and prevent late scarring tissues and disabilities development. The indication of     high doses of MA is based on the evidence that there could be induction of resistance with     use of subdoses. However, clinical studies with extended follow-up in Rio de Janeiro have     suggested that regular low MA doses (5mg / kg / day) in a systemic way may constitute an     effective scheme, achieving cure rates similar to higher dose, with lower toxicity, ease of     implementation and lower cost. Published studies on efficacy and safety of alternative     schemes with meglumine antimoniate failed to provide conclusive results, for various     methodological biases. The need to compare the effectiveness and safety between treatment     schemes with meglumine antimoniate currently recommended in Brazil for the treatment of ML or     MCL and an alternative scheme with low dose of antimony is the motive for this study in Rio     de Janeiro.   "
151414|NCT01301924|"     Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and     Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis  has begun     in October 2008 at the Laboratory of Leishmaniasis Surveillance at Evandro Chagas Clinical     Research Institute (IPEC), FIOCRUZ, aiming to compare efficacy and safety of the standard     recommended schedule with an alternative dosage scheme of meglumine antimoniate in the     treatment of American tegumentary leishmaniasis (ATL). It is a study with blind evaluation by     the doctors and the responsible for statistical analysis. Patients diagnosed with ATL,     eligible for the trial are randomly allocated into one of the schemes with meglumine     antimoniate and monitored before, during and after it. There is no single regimen applicable     to all forms of leishmaniasis around the world. Therapeutic regimens applied to treat people     living in other geographic areas result in mixed outcomes. Ideally, the most appropriate     regimens should be established for each endemic area, based on its efficacy, toxicity,     difficulties of administration and cost. Given the problems and limitations of the use of     pentavalent antimonials (Sb5+) at 20 mg Sb5+ / kg / day, less toxic alternative regimens,     i.e. 5mg Sb5+/kg/day, deserve to be better evaluated. The treatment of ATL must heal skin     lesions and prevent late mucosal lesion development. The indication of high doses of Sb5+ is     based on the evidence that there could be induction of resistance with use of subdoses.     However, clinical studies with extended follow-up in Rio de Janeiro have suggested that     regular low doses (5mg Sb5+ / kg / day) may constitute an effective scheme, achieving cure     rates similar to higher doses, with lower toxicity, ease of implementation and lower cost.     Published studies on efficacy and safety of alternative dosage schemes with meglumine     antimoniate failed to provide conclusive results so far, for various methodological biases.     The need to compare the effectiveness and safety between the standard treatment scheme with     meglumine antimoniate currently recommended in Brazil for the treatment of ATL and an     alternative scheme with low doses of antimony is the motive for this study in Rio de Janeiro.   "
151415|NCT01301911|"     Cipatinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This     study is designed to evaluate the safety and tolerability of cipatinib in patients with HER2     positive or uncertain advanced breast cancer:        1. To evaluate the safety and tolerability of cipatinib, and the maximum tolerated dose          (MTD) and dose-limiting toxicity (DLT)        2. To determine the pharmacokinetic profile of cipatinib and its metabolites        3. To assess preliminary antitumor activity        4. To determine preliminary regimen for phase II study        5. To determine the relation of expression of HER-1 and HER-2 to the antitumor activity.   "
151416|NCT01301898|"     The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant human     iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) patients   "
151429|NCT01301729|"     This single arm, open-label study will evaluate the efficacy and safety of Herceptin     (trastuzumab) in combination with a taxane as first line therapy in participants with     HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment.     Participants will receive Herceptin (loading dose of 4 mg/kg intravenously [iv], 2 mg/kg iv     weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or     paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease     progression or unacceptable toxicity occurs.   "
151430|NCT01301716|"     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,     tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and     carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with     locally advanced or metastatic solid tumors.   "
151619|NCT01299220|"     This study will look at if a low-dose regimen of acitretin is helpful in treating a skin rash     caused by the chemotherapy drug, erlotinib.   "
151417|NCT01301885|"     Endometriosis is a chronic disease characterized by the presence of functional endometrial     glands and stroma in ectopic locations outside the uterine cavity. The ectopic endometrial     tissue responds to estradiol and other hormones similarly to the normal endometrium.     Endometriosis is one of the most common benign gynecological conditions, as many as 5-10% of     women in the reproductive age may be affected. In addition to pain which may be severe,     subfertility is one of the typical problems associated with endometriosis and may be present     in up to 40% of those affected. There is lack of a clear correlation between severity of pain     and degree of compromised fertility. Different modes of treatment exist. Hormonal treatments     are based on the suppression of estrogenic action on endometriosis as well as the     endometrium. Unfortunately, discontinuation of the hormonal treatment typically results in a     rapid recurrence of the disease. Surgery may alleviate the symptom for different lengths of     time, however, curative treatment frequently involves hysterectomy with bilateral     oophorectomy. In order to escape this radical treatment, new targeted therapy in the form of     novel pharmacological agents would be of crucial importance. Presently, endometriosis can be     reliably diagnosed only by laparoscopy. Since this is an invasive surgical procedure, new     diagnostic tools would be warmly welcomed. Furthermore, as the progression of the disease is     presently impossible to predict, new markers for the malignancy of each case are     desperately needed.      The aim of the investigators research is to identify expression of endometriosis specific     RNAs/proteins. Evaluation of expression profiles in samples of endometriosis and endometrium     of patients with careful clinical and surgical classification of endometriosis as well as     healthy control women should initially enable to identify novel targets for new therapies and     biomarkers. Furthermore, combined with an adequate follow up, the study should enable for     example to identify markers for endometriosis associated infertility as well as cases where     the disease progresses very rapidly. Different forms of effective treatment may thereafter be     designed following the identification of such factors.   "
151418|NCT01301872|"     During the past two decades, there current concept has evolved significantly that     ventilator-induced lung injury (VILI) may not only impose a direct mechanical stress and     subsequent injury to the lungs, but may also induce local as well as systemic inflammation     responses, generally referred as biotrauma.1 Patients with ARDS often die of severe systemic     inflammatory response syndrome (SIRS) and multiorgan dysfunction2 rather than refractory     hypoxemia. Ranieri et al found that patients with less severe ARDS, i.e., a lung injury score     of 2.5 or less, receiving ventilation with lung protective strategy involving low tidal     volume (7.5 mL/kg PBW) and high PEEP could attenuate the pulmonary and systemic cytokine     response compared with conventional ventilation with high tidal volume.3 Stuber et al found     an increase in pro-inflammatory cytokines in the lung and plasma of patients with ARDS within     1 hour after switching the patients from a protective to non-protective ventilator strategy.4     The receptor for advanced glycation end-products (RAGE) was recently identified as a marker     of injury to the alveolar type I epithelial cells5. Clinical studies showed that the plasma     level of RAGE was associated with severity of lung injury and clinical outcome, and low tidal     volume strategy ventilation accelerated the decline in plasma RAGE levels. These results     suggest plasma RAGE level might be a reliable biomarker of alveolar epithelial injury in     acute lung injury and may associated with ventilator induced lung injury6. Although, current     approach to mechanical ventilation of a patient with ARDS emphasizes the use of lower tidal     volumes with lower plateau pressures to avoid causing lung overdistension and ventilator     associated lung injury (VILI)7; however, in the real world, some studies showed that strictly     reduction of tidal volume to 6ml/kg PBW was modest in modern time, and was noticed only in     patients with greater lung injury scores8. The benefit of VT strictly reduction to 6ml/kgPBW     and its effect on VILI in patients with less severe ARDS whose Pplat are already below 30     cmH2O are controversy9. One of the possible solutions is to look at the biomarkers of injury     to alveolar epithelial cells. Of these potentially promising markers, the receptor for     advanced glycation end-product (RAGE) is of great interest.      We hypothesize that a strategy with strict low tidal volume in less severe ARDS and ALI     patients with good compliance may be beneficial to this patient population. Therefore, we     wish to propose a prospective single-center study to investigate the effect of mechanical     ventilation strategy on the plasma level of RAGE in patients with less severe ARDS and acute     lung injury.   "
151419|NCT01301859|"     The study is a randomized controlled trial to test the usefulness of a brief intervention to     improve adherence to antidepressant medication prescribed to older adults in a primary care     setting. Study will be conducted at Weill Cornell and University of Michigan.   "
151420|NCT01301846|"     To explore the relationship between ability to do different wheelchair skills and the     participation and quality of life of wheelchair users in and around their home and community.     The investigators study hypothesis:        1. Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is          strongly related to self-reported participation.        2. Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is related          to the average daily distance traveled in their wheelchair.   "
151421|NCT01301833|"     The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as     monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2     Diabetes for 52 weeks administration.   "
151422|NCT01301820|"     Phase II Multicentric Trial Open Label, Multicenter, randomized to evaluate the efficacy of a     Maintenance Therapy in First Complete Remission After Induction for Elderly (≥ 60) Fit     Patients With Poor Prognosis Acute Myeloid Leukemia (AML).      The disease-free survival (DFS) of the patients included in this study will be compared to     the ones of the two previously reported groups of patients treated with the same LIA     induction therapy   "
151423|NCT01301807|"     The goal of this clinical research study is to find the highest tolerable dose levels of     carfilzomib and LBH589 (panobinostat) that can be given in combination to patients with     myeloma. The safety of this drug combination will also be studied.   "
151424|NCT01301794|"     High levels of triglycerides is a common abnormality found in patients with diabetes and also     cardiovascular disease, and may contribute to the risk for both. Omega 3 fatty acids, as     found enriched in fish and also in the commercial agent called Lovaza lower triglyceride     levels. Prior work from the investigators group demonstrated that an enzyme responsible for     the break down of triglycerides - lipoprotein lipase - generates molecules that can activate     a specific nuclear receptor known as PPAR-alpha. This study investigates the hypothesis that     taking Lovaza shifts the specific fatty acid content of triglyceride containing lipoproteins     and increases the ability of those lipoproteins to activate PPAR-alpha.   "
151425|NCT01301781|"     A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated     adults.   "
151426|NCT01301768|"     The purpose of this study is to assess the effectiveness of individual education versus group     education about dietary habits and iodine supplementation to decrease iodine deficiency in     pregnant women   "
151427|NCT01301755|"     Invasive aspergillosis is a serious and often fatal infection in patients who are neutropenic     or have undergone solid organ or stem cell transplantation. However, early diagnosis of     invasive aspergillosis is a challenge. Reiss and Lehmann first described the value of serum     Galactomanna (GM) for diagnosis of invasive pulmonary aspergillosis in 1979. The availability     of the Platelia Aspergillus, a sandwich ELISA that has been approved by FDA in 2003 for     managing patients at risk of invasive aspergillosis because of the early detection of the GM     antigen. In several studies so far the specificity of the serum galactomannan assay was     greater than 85%; however, variable sensitivity from 29~100% was noted over years. In     addition, low values and false-negative results are seen more often in nonneutropenic and     solid organ transplantation patients as opposed to severely granulocytopenic patients .There     are several factors that might explain the reported difference in the performance of antigen     detection, including the biological factors and epidemiological factors.      In recent years, specimens of other body fluids are increasingly used for detection of     Aspergillus galactomannan antigen, including urine, bronchoalveolar lavage(BAL) fluid,     cerebrospinal fluid and even the tissue specimen. However, the sensitivity and specificity of     the GM detection in various specimens still have considerably variation. Ultrasound-guided     transthoracic aspirate is a safe and useful method for collecting specimens for accurate     bacteriologic diagnosis of lung abscess and obstructive pneumonitis10. We also reported a     study of diagnosis of pulmonary Cryptococosis by ultrasound guided percutaneous aspiration.     We plan to perform a prospective single-center study to investigate the role of GM in the     target organ (lung tissue/fluid) by using ultrasound-guided fine needle aspirate for early     diagnosis invasive aspergillosis compared with the serum galactomannan.   "
151432|NCT01301690|"     3,6-bis(1-methyl-4-vinylpyridinium) carbazole diiodide (BMVC) is an inorganic chemical     compound (Figure1). The uptake of BMVC in cancer cells and normal cells are different.     Recently, a simple handheld device (Figure1) based on the fluorescence analysis of stained     cells was established to instantly differentiate cancer cells from normal cells. The     investigators want to quantitatively measure the fluorescence expression of BMVC in normal     and cancer cells and explore the usefulness of this staining in head and neck lumps.   "
151433|NCT01301677|"     Double blinded (subject and observer), randomised, active (hydrocortisone (HC)) controlled     study of the effect of strontium chloride hexahydrate on ultraviolet B radiation (UVR)     induced signs of inflammation (erythema and pain) in healthy volunteers.   "
151434|NCT01301664|"     In this study, the investigators explored the hypothesis that osteoarthritic cartilage     fragments can promote chondrogenesis of MSCs. Non-wearing parts of cartilage tissues were     harvested from one osteoarthritic patient during the total knee arthroplasty surgery.     Cartilage fragments and MSCs were wrapped into fibrin glue; and the constructs were implanted     subcutaneously into nude mice.      Moreover, the investigators will collect the discard cartilage to develop an acellular     cartilage ECM-derived scaffold in the joint replacement surgery. In addition, the     investigators will harvest the redundant bone marrow from drilling or useless synovium during     the surgery to separate the mesenchymal stem cells. Furthermore, these mesenchymal stem cells     will be transfected with hTERT for rejuvenation and then will be labeled with fluorescent dye     PKH26 for application of animal study. To sum up, the investigators plan to use human,     natural, and discard materials from the joint replacement surgery to develop appropriate     allograft for cartilage repair and hope that one day this ideal would be apply in clinical.   "
151435|NCT01301651|"     Background and Objective: Postural instability is common in patient with Parkinson's disease     (PD). The purpose of this study was to investigate the effects of virtual reality (VR)     balance training on sensory and cognitive domains of postural control.      Setting: Balance Performance Laboratory. Participants: A total of 42 patients (Hoehn and Yahr     stage II-III) were recruited and assigned into three groups randomly.      Intervention: Participants in the virtual reality (VR) group and conventional balance     training (CB) group received a 6 weeks balance training program. The control group (CG) did     not receive any training.      Outcome Measures: The sensory organization tests (SOT) of computerized dynamic posturography     with single and dual tasks (i.e. with backward subtraction of number) were examined pre-,     post-training and follow-up. The equilibrium score (ES) and sensory ratio were measured. The     verbal reaction time (VRT) was recorded.      Results: (1) Only VR significantly increased ES of SOT-6 (i.e., vestibular function at visual     and somatosensory conflicting condition) post-training more than CG post-training in either     single or dual task. (2) Only CB training significantly increased SOT-5 (i.e., vestibular     function without visual conflict) and vestibular sensory ratio (i.e., SOT-5/SOT-1) more than     CG post-training in either single or dual task. (3) (3) Neither VR nor CB training reduced     VRT significantly under six sensory conditions at post-training and follow-up.      Conclusion: Both VR training and CB training can improve sensory organization for postural     control by enhancing utilization of vestibular information, but VR could enhance vestibular     function with conflicting proprioceptive and visual information under single and dual tasks     in patients with mild to moderate PD.   "
151436|NCT01301638|"     Before Daptomycin (Cubicin ®) approved by the U.S. FDA in 2003, There were large-scale     clinical trials conducted that included more than 1,000 subjects and than Daptomycin got     complicated skin and soft tissue infections (CSSSI) indication. After 2004, Daptomycin got     new indications about bacteremia and endocarditis due to success outcomes in the clinical     trial which included infected in blood flow and endocardial infected patients.      All subjects in Daptomycin clinical trials are European and American race. It is necessary     that collecting safety and efficacy data of Daptomycin in Taiwan race. I will intent to     evaluate the safety and efficacy of Daptomycin which were used in patients with serious     gram-positive infections retrospectively. And the outcome could be a reference for Daptomycin     future using.   "
151437|NCT01301625|"     The primary objective of the MitraClip System ANZ Clinical Trial is to gather real-world     clinical and health-economic outcome data to support the long-term safety, efficacy and     economic value of the MitraClip System in the continuum of therapies for treating MR.     Specifically, the following clinical and economic data will be collected: New York Heart     Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life     (QOL) information, echocardiographic measures of left ventricular size and function, and data     associated with the index hospitalization, rehospitalizations, concomitant medications and     discharge facility to support the MitraClip System economic analysis.   "
151438|NCT01301612|"     The primary study objective will be to assess the efficacy of the combination of radiation     therapy with nimotuzumab and cisplatin, as compared to the combination of radiation therapy     plus cisplatin in the treatment of Uterine Cervical Carcinoma (UCC).      The secondary study objectives will be safety and tolerability evaluations, to determine     treatment feasibility and the interim efficacy evaluation according to other parameters     routinely used in oncology.   "
151439|NCT01301599|"     This study is designed to investigate the comparison between alpha blocker monotherapy and     5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic     hyperplasia.   "
151440|NCT01301586|"     The purpose of this study is to evaluate a novel, combination product for the treatment of     acne vulgaris in females   "
156376|NCT01236911|"     Will have bad prognosis the patients with low calcium (less of 24 hrs of te admission in     hospital)after moderate - severe TBI that the patients that do not developed this condition?   "
151441|NCT01301573|"     The purpose of this observational study is the long term follow-up of Parkinson's patients     who participated in a clinical trial in which they received AAV-GAD gene transfer into the     subthalamic nucleus (STN) region of the brain. Patients will be followed once a year for up     to five (5) years. The study will monitor and evaluate the long term effects of AAV-GAD and     provide long term safety information.   "
151442|NCT01301560|"     The need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non     small cell lung cancer (NSCLC).      Therefore, the investigators do a randomized study comparing overall survival between two     groups with or without radiosurgery for asymptomatic oligo brain metastasis before palliative     chemotherapy for NSCLC.   "
151443|NCT01301534|"     Standard of care dictates that eligible patients should receive an abdominal aortic aneurysm     (AAA) screening ultrasound. At present, different military primary care physicians utilize     different methods at their discretion to ensure their patients get screened—telephone     contact; mail-out reminders; referring patients for ultrasound directly from an office visit;     as well as other methods—which we will refer to as usual care. The purpose of this study is     to improve screening rates for AAA and determine what notification methods are best at     improving screening rates.   "
151444|NCT01301521|"     The purpose of this study is to assess whether water-soluble cinnamon extract plus aggressive     lifestyle intervention is effective in lowering blood glucose in pre-diabetic patients when     compared to aggressive lifestyle therapy plus placebo.   "
151445|NCT01301508|"     The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and     effective treatments for mild-to-moderate atopic dermatitis (AD).   "
151446|NCT01301495|"     In this study, a newly designed and FDA approved fully covered metal stents will be used to     palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be assessed     before and after treatment to confirm efficacy   "
151447|NCT01301482|"     The purpose of this study is to assess the effect of ear acupuncture alone in subjects with a     contraindication to anti-inflammatory medications in the reduction of pain and hours lost     from work in acute sore throat.   "
151448|NCT01301469|"     The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte     infusion in comparison to HES 130/0.4 in a sodium chloride infusion.   "
151449|NCT01301456|"     The primary objective of this study is to evaluate the safety and tolerability of PF-04856883     (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.   "
151450|NCT01301443|"     The purpose of this first in man study is to examine the safety of an experimental gene     transfer agent, RetinoStat, designed to treat neovascular age-related macular degeneration.   "
151451|NCT01301430|"     Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects     suffering from glioblastoma multiforme.   "
151452|NCT01301417|"     The proposed study is a post marketing, observational, retrospective data collection intended     to gather and record data on patients treated with the ColonRing™ device in routine clinical     practice at a single center. The data will assist in further evaluating the performance of     the ColonRing™ device in regards to the creation of a colorectal anastomosis.      Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will     be within the acceptable range reported in the literature for alternative treatment     modalities.   "
151453|NCT01301404|"     PONV after intrathecal morphine, occurs up to 30-40 percent. The patients having TKR normally     are female, obese and non-smoker which are risk factors for PONV. Recently, a multimodal     approach, combining several means to minimize PONV, has found wide acceptance as a standard     of care. In our hospital, most of the patients are supposed to fast after midnight The oral     rehydration therapy reduce patients thirst and increase his satisfaction, but whether or not     this method can reduce the incidence of PONV after low dose (0.2 mg) intrathecal morphine is     not investigated yet. The aim of this study is to investigate the effect of preoperative oral     rehydration therapy on the incidence of PONV.   "
151454|NCT01301391|"     The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with     recurrent or metastatic, unresectable malignant thymoma previously treated with multiple     lines of chemotherapy.   "
151455|NCT01301378|"     The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the     Molteno 3 glaucoma drainage device during surgery   "
151456|NCT01301365|"     The aim of this study is to check whether patients with cystoscopic findings supporting the     diagnosis of Interstitial Cystitis (IC) have a higher autonomic response (change in blood     pressure / pulse)than patients without cystoscopic findings.   "
151457|NCT01301352|"     The investigators are studying whether it is safe and effective to provide enteral nutrition     to critically ill children via the nasogastric route, as opposed to the nasojejunal route,     while they are receiving noninvasive positive pressure ventilation.   "
151458|NCT01301339|"     The purpose of this study is to evaluate the prevalence of pre-diabetes and diabetes among     those Air Force personnel who have not passed the Air Force physical fitness test (AFPT) and     to evaluate the usefulness of the AFPT as a prescreening tool for these disease processes.   "
151459|NCT01301326|"     Best treatment option of retinal arterial macroaneurysm is still controversial. A recent     publication has shown that subthreshold laser treatment can be beneficial in improving visual     acuity in eyes with symptomatic retinal arterial macroaneurysm. Aim of the study is to     compare the effects of subthreshold laser treatment and threshold laser treatment in patients     affected by symptomatic retinal arterial macroaneurysm.   "
151460|NCT01301313|"     To evaluate the efficacy and safety of levosimendan versus conventional intensified inotropic     treatment, in critical children with severe acute heart failure which persists despite of     having received conventional inotropic treatment.   "
151557|NCT01300026|"     This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with     relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose     exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid     malignancies and uses a practical continuous reassessment model [CRM] to guide dose     escalation and to define the MTD. The dose expansion in part 2 will enroll 20 subjects with     CLL at a dose no higher than the MTD and further explore the safety, PK, and clinical     activity of AMG 319 in this patient population.   "
151538|NCT01300286|"     The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL     Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving     hemostasis thereby reducing overall blood product transfusion after separation from     cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size     this is a pilot study and in effect will determine the fibrinogen level response to     fibrinogen concentrate administered during aortic reconstructive surgery. It will be     underpowered to detect reduction in bleeding but comparison to historical controls will be     included as a secondary outcome.   "
151539|NCT01300273|"     The investigators hypothesize that, LPD supplemented with ketoanalogs will reduce urine     podocyte loss and lower the angiotensinogen level in the urine.   "
151461|NCT01301300|"     Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™     provides passive disinfection of valve top and threads without activating the luer access     valve. This product promotes technique standardization and compliance in cleansing of the     luer access valve prior to access. It acts as a physical barrier from touch and airborne     contamination for up to 96 hours. This product has been endorsed and will be adopted for use     at NorthShore University HealthSystem as a quality improvement initiative. This research     study protocol is designed to confirm the anticipated benefit of this change in practice at     NorthShore during the planned implementation and use.      If the product performs as it has been designed to, the baseline rate of hub and subsequently     intraluminal contamination will be diminished, thereby protecting patients with central lines     from bloodstream infections due to contaminated hubs.   "
151462|NCT01301287|"     Chlorella, a type of unicellular fresh water algae, has been a popular foodstuff in Asia,     especially in Taiwan. Recent studies have shown the hypoglycemic effects of Chlorella through     increasing glucose uptake in the liver and muscle, lowering serum free fatty acid levels, or     activation of PPAR gamma receptor. However, the hypoglycemic effect in diabetic patients have     not been studied. In order to clarify the hypoglycemic effects and mechanism of Chlorella in     diabetic patients, the investigators conducted a 12-week randomized, double-blind,     placebo-control trial on diabetic patients.   "
151463|NCT01301274|"     The primary objective of this study is to compare the mean serum sodium after 48 hours of     therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill     children requiring IV maintenance fluid administration.   "
151464|NCT01301261|"     Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular     blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to     the reversal of the neuromuscular block. The aim of the study was to investigate the pure     effects of sugammadex in the absence of the agonist.   "
151465|NCT01301248|"     To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further     addition of cetuximab experimental treatment   "
151466|NCT01301235|"     This is a developmental protocol to determine the MRI based 31P-MRS changes seen in subjects     with mitochondrial myopathy using our dynamic exercise protocol and to identify the ideal     variable(s) to represent mitochondrial function.   "
151467|NCT01301222|"     This randomized controlled trial (RCT) aims at assessing the influence of octreotide on     pancreatic fistula or complications following pancreatoduodenectomy in patients with soft     pancreas. Previously reported trials have included all types of pancreatic resections and     have include all types of pancreas and have shown no clearcut benefit of octreotide after     pancreaticoduodenectomy (PD). Soft pancreas and normal sized duct are the risk factors for     fistula following PD. This study's focus is on this select group of patients and aims to     assess the role of octreotide in patients with soft pancreas.   "
151468|NCT01301209|"     Prospective observational study to evaluate the impact of Recto-Anal-Repair (a technique of     ultrasound guided haemorrhoidal ligation) in the treatment of stage III/IV haemorrhoidal     disease.   "
151469|NCT01301196|"     Excessive periods of time spent sitting may be a risk factor for diabetes. Current lifestyles     encourage large amounts of sitting (sedentary behaviour) through increasing car use,     computers, and appealing screen-based home entertainment systems. Methods to help change such     behaviours are now needed, particularly for those with a high risk of developing a chronic     disease, such as diabetes. The investigators propose to decrease sedentary behaviour in a     multi-ethnic group of young adults at risk of diabetes through an educational intervention     (attending a workshop and having prompts). If successful, this could have significant public     health benefits given the widespread nature of sedentary behaviour.   "
151470|NCT01301183|"     Teenage girls with anorexia nervosa (AN) are at risk for low bone density and low rates of     bone accrual, raising concerns regarding acquisition of peak bone mass, an important     determinant of future bone health and fracture risk. Important factors contributing to low     bone density in AN include low levels of estrogen and insulin like growth factor-1 (IGF-1).     While estrogen is important for preventing bone loss, IGF-1 is important for optimizing bone     formation. We have shown in a previous study that replacement of estrogen is effective in     increasing bone density in teenage girls with AN; however, this increase in bone density     remains lower than that seen in normal-weight controls over the same duration, and residual     deficits persist. Importantly, the impact of administering replacement doses of IGF-1 with     estrogen replacement has not been studied in teenagers with AN.      This study will examine the impact of administering recombinant human (rh) insulin like     growth factor-1 (rhIGF-1) with estrogen (to mimic pubertal levels of these hormones) versus     administration of estrogen alone on bone metabolism in adolescent girls with anorexia nervosa     (AN).      One aim of this proposal is to investigate whether co-administration of insulin like growth     factor-1 (rhIGF-1) with physiologic estradiol replacement to adolescent girls with AN will     increase BMD (bone mineral density) more than estrogen monotherapy, and whether bone mass     will approach that seen in healthy adolescent girls. An additional aim is to determine     whether co-administration of rhIGF-1 with estradiol to mimic the normal pubertal milieu     stimulates bone formation through an IGF-1 mediated anabolic effect, increases bone density     to a greater extent than estrogen monotherapy, and improves bone mass accrual to approach     that in healthy controls. The impact of rhIGF-1 +estradiol versus estradiol alone on bone     microarchitecture will also be assessed.   "
151471|NCT01301170|"     The purpose of this study is to determine whether individuals with neck pain will respond     favorably to a program of manual therapy, directed at the cervical and thoracic spine     (including thrust manipulation), and exercise, in combination with dry needling, as compared     to manual therapy, directed to the cervical and thoracic spine (including thrust     manipulation), and an exercise program alone.   "
151472|NCT01301157|"     This study is to evaluate the efficacy and safety of M518101 and the dose relationship among     two doses of M518101 and placebo in male and female plaque psoriasis patients.   "
151492|NCT01300897|"     Biofeedback therapy improves bowel symptoms and anorectal function in patients with     dyssynergic defecation, however its mechanism of action is not known. The investigators     hypothesize that biofeedback therapy enhances gut-brain-gut communication by altering     cortical processing of information and improving cortically mediated neuromuscular function     of the gut. However, in order to better understand these mechanisms in patients, the     investigators need to examine and establish normative data and compare findings with healthy     subjects. The investigators specific aims are to examine and evaluate the following 40 normal     subjects; (1) To evaluate the afferent cortical evoked potentials in response to the     electrical stimulation of the anorectum and (2) To evaluate the corticofugal tracts     (efferent) by recording the anal and rectal electromyographic responses following noninvasive     lumbosacral and transcranial magnetic stimulation.   "
151708|NCT01298037|"     This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort     Study NCT01263587. This study will examine the balance between immune regulatory and effector     responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).   "
151473|NCT01301144|"     Background:        -  Tuberculosis is a disease of the lungs caused by the bacteria Mycobacterium tuberculosis          (M. tuberculosis). The most popular and least expensive tool used to detect the presence          of the tuberculosis bacteria is called sputum smears, which is a lab test used to look          for bacteria in the sputum via a microscope. However, the test s results are not always          accurate, and the test cannot determine if the bacteria will be resistant to standard          tuberculosis treatments. The most sensitive test currently available is called sputum          culture, in which a sputum sample is used to check for the growth of tuberculosis          bacteria. However, this test takes at least a month to produce accurate results, and          requires expensive equipment that is not available in many countries where M.          tuberculosis is found.        -  The urea breath test (UBT) has been used to detect infection with Helicobacter pylori, a          bacteria associated with stomach ulcers, by testing individual breath samples.          Researchers are interested in determining whether breath samples can also be used to          detect the presence of M. tuberculosis in the lungs of subjects with tuberculosis, and          to see if tuberculosis treatments are successful.      Objectives:      - To assess the sensitivity and specificity of urea breath testing in the diagnosis and     treatment response of pulmonary tuberculosis.      Eligibility:        -  Individuals at least 18 years of age who either have been diagnosed with tuberculosis or          are healthy volunteers with no past history of tuberculosis.        -  The study will be conducted in Bamako, Mali.      Design:        -  This study will involve three groups: two pilot groups of individuals who have already          been diagnosed with tuberculosis, and a primary study group of both healthy volunteers          and individuals who have been diagnosed with tuberculosis.        -  Participants will be screened with a physical examination and medical history, as well          as blood, sputum, stool, and urine samples.        -  First pilot group (one visit):        -  Participants should not eat, drink, or smoke for at least 1 hour prior to the UBT test.        -  Participants will provide a baseline exhaled air sample, and then will receive the UBT          test, which involves a dose of Pranactin -Citric dissolved in water. Additional exhaled          air samples will be collected at eight time points (10, 20, 45, 60, 90, 120, 180, and          240 minutes after the dose).        -  Second pilot group (one or two visits):        -  Participants should not eat, drink, or smoke for at least 1 hour prior to the UBT test.        -  Participants will provide a baseline exhaled air sample, and then will receive the UBT          test. Half of the participants will receive a dose of bismuth (Pepto-Bismol) prior to          collection of air samples to see how this affects the results of the UBT test.          Additional exhaled air samples will be collected at three time points specified by the          study researchers.        -  On the following day, participants will return for a second visit to provide three more          exhaled air samples.        -  Primary study group (five visits for participants with tuberculosis, two visits for          healthy volunteers):        -  All participants will have two visits, following the procedures given for the second          pilot group. Half will receive a dose of bismuth prior to collection of air samples.        -  Participants with tuberculosis will have three additional visits (days 6, 10, and 16          following the first study visit) to provide additional sputum and exhaled air samples to          monitor the progress of tuberculosis treatment.   "
151474|NCT01301131|"     Hospitalized patients with ventilator are randomized to receive fermented dairy product     containing L. casei shirota or nothing. The main outcome is development of     ventilator-associated pneumonia (VAP)   "
151475|NCT01301118|"     SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS      INTRODUCTION: Infection is cause of increased morbidity and mortality in burn patients, and     its control is a major challenge also for skin graft integration. Wound and soft tissue     infection rates are higher than microbiological diagnosis rates.      PURPOSE: To evaluate partial skin graft integration in relation to microbiological analysis     of wounds in burn patients.      METHODS: This project will be a transversal, prospective, analytical, controlled study in     humans, conducted in a single center, at Burn Care Unit of Department of Plastic Surgery at     Federal University of São Paulo from October, 2010 to October, 2011. Data will be collected     to characterize demographic and clinical aspects. Data analysis will be performed using     Student's t-test and Friedman analysis of variance.   "
151476|NCT01301105|"     The project's objective is to explore the impact of Mindfulness-Based-Stress-Reduction (MBSR)     on pain regulation, social stress, basic affective and attention functions, and on the brain,     immune, and endocrine mechanisms that subserve these processes. Specifically, the     investigators hypothesize that participants undergoing MBSR training will show decreased     emotional distress on self-report measures, increased sustained attention on a behavioral     task, decreased stress levels on a social stress test, decreased general psychosocial stress     as indexed by diurnal salivary cortisol profile, changes in inflammatory response, modulation     of cellular aging, and different neural patterns in response to thermal pain and aversive     visual stimuli as indexed by functional Magnetic Resonance Imaging (fMRI).      To test these hypotheses, the study will recruit 50 participants through the UW-Madison     Integrative Medicine Program. All participants will be randomly assigned either to an 8-week     MBSR program or to an 8-week training program in health-enhancement. At the conclusion of the     study, participants will be invited to participate to the second class should they be     interested. Participants will complete self-report questionnaires, behavioral tasks, fMRI     scanning, cortisol sampling, and blood sampling before training begins, after the first     program ends, and again four months after the first program ends and prior to the second     program.      If hypotheses are supported, the study may benefit participants by reducing their     psychological distress, increasing their well-being, and helping them better manage pain and     aversive stimuli. There are no other direct benefits to participants. Potential risks     associated with fMRI include ferromagnetic collision, neurostimulation effects, and     psychological discomfort. Potential risks to subjects include slight potential discomfort in     providing saliva samples, discomfort of painful thermal stimulation, stress associated with     the Trier Social Stress Test, some psychological discomfort from viewing disturbing     photographs as part of the compassion fMRI study, and breach of confidentiality.      Consent for the present study will entail both written and verbal descriptions of the     protocol. Subjects will be informed that their participation is completely voluntary, and     that they can withdraw at any time.   "
151477|NCT01301092|"     LY2189265 is an investigational drug being developed for the treatment of type 2 diabetes     mellitus. This study will compare the concentrations of LY2189265 using different methods of     administration: subcutaneous (or SC- an injection just under the skin), intravenous (or IV -     into a vein in the arm) and intramuscular (IM - into the muscle of the left thigh). The     purpose of this study is to look at how much of the drug gets into the blood stream and how     long it takes the body to get rid of it when given by the methods above. The study is divided     into three parts, Part A, B and C. Volunteers will only be able to participate in one part.     All Participants in Part A will receive a single IV dose of up to 0.1 milligram (mg).     Participants in Part B will be given drug twice by IV and an SC injection (1.5 mg). Part B of     the study will occur after Part A because the dose of IV drug will depend on the results of     Part A. Part B of the study may not occur if the volunteers in Part A do not tolerate the     drug. Participants in Part C will also be given drug twice by an SC injection and an IM     injection, both doses will be 0.75 mg.   "
151478|NCT01301079|"     The aim of this study was to determine if the addition of ketamine reduces     remifentanil-induced hyperalgesia, improves its analgesic effect, inhibits IL(interleukin)-6     and IL-8 (inflammatory cytokines), and stimulates IL-10 (an anti-inflammatory cytokine).   "
151479|NCT01301066|"     A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.   "
151480|NCT01301053|"     The investigators believe that there remains a gap in implementing insulin infusions in     critically ill patients to maximize the benefit and minimize adverse events like episodes of     hypoglycemia. Based on the published experience with Continuous Glucose Monitor (CGM), the     investigators believe that it is safe to use in critically ill patients. Furthermore, the     investigators believe that in combination with a protocol with low risk for hypoglycemia at     baseline, that CGM can eliminate this risk fully.      In this study the investigators will:        1. Study the safety and feasibility of the continuous glucose monitor use in 20 critically          ill patients for 7 days (the current maximum recommendation for sensor use). Safety data          will include the rate of significant bleeding (hematoma) or infection (cellulitis) from          sensor use. Feasibility data will evaluate the amount of missing glucose data over the          7-day sensor life.        2. Randomize patients treated with the current UVA intensive care insulin protocol for          insulin management to the addition of brakes that reduce insulin administration based          on continuous glucose monitoring data between hourly reference glucose data to prevent          episodes of hypoglycemia (blood glucose <70 mg/dl) and severe hypoglycemia (blood          glucose <50 mg/dl). This will serve as pilot data to power a larger study in the future.   "
151481|NCT01301040|"     The primary objective is to evaluate the difference in cardiac strain rate evolution in     elderly early BC patients treated with (neo) adjuvant anthracycline-based chemotherapy     compared with a non-anthracycline regimen (Taxotere-cyclophosphamide) CT.      This study also will compare the serum biomarkers profile during and after the (neo) adjuvant     CT in both treatment arms, assess whether MRI allows detecting earlier than standard     echocardiography the signs of cardiotoxicity, during and after adjuvant (neo) CT, assess     whether brain PET-CT allows detecting regional functional impairment in patients receiving     CT, evaluate cognitive function before and after (neo) adjuvant CT in both treatment arms,     evaluate distress and functional autonomy before and after (neo) adjuvant CT in both     treatment arms, evaluate psychological state and burden of primary caregivers before and     after (neo) adjuvant CT in both treatment arms, evaluate primary caregivers abilities to     detect patients' distress and functional autonomy before and after (neo) adjuvant CT in both     treatment arms, evaluate the short and long-term toxicity profile of the regimens, estimate     the 10-year risk of relapse and/or death using the Adjuvant!Online tool, and estimate the     Framingham risk score for Hard Coronary Heart Disease (10-year risk).   "
151482|NCT01301027|"     This is a double blinded randomized clinical trial of pioglitazone vs. placebo in overweight     or obese, diabetic and non-diabetic hemodialysis patients. This study will examine whether     pioglitazone modulates adipokine production by adipose tissue in hemodialysis patients and     whether these changes result in reduction of inflammation, insulin resistance and oxidative     stress and increase in muscle mass.      In addition, this study will also examine the associations of adiposity with adipokines and     the metabolic milieu in hemodialysis patients to better understand the biology of adipocytes     in uremic milieu.   "
151483|NCT01301014|"     This study is investigating the reliability and diagnostic accuracy of a Lachman's test     conducted in a prone position to detect the presence of a torn anterior cruciate ligament.   "
151484|NCT01301001|"     The Specific aims of this project are to (1) test the prediction that pain from tampon     insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin     compared to when treated with placebo. Secondary outcome measures include intercourse pain     and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and     to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more     specific treatment options.   "
151485|NCT01300988|"     The investigators' in vitro data suggest that Neurokinin-1 receptor antagonists like     aprepitant will decrease the expression of CCR5, an essential co-receptor in the life cycle     of HIV, in the surface of macrophages and lymphocytes to levels at least similar to those     observed in patients heterozygous for the CCR5 32 mutation. Together with a direct potential     antiviral effect this could alter disease progression in patients with HIV infection.      The investigators' hypothesis is that aprepitant is safe, tolerable and has antiviral     activity in HIV infected individuals.      This is randomized, placebo controlled, double blind study to determine the safety and     antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks     of aprepitant monotherapy.      18 HIV infected males and females ≥ 18 years old who have early infection with CD4 cell     counts ≥ 350 cells/mm3. Subjects will be randomized 1:1 to receive 375 mg of aprepitant     (Emend®) or placebo.   "
151486|NCT01300975|"     Intralesional injection of antimony has been used for L major from Iran with a modest cure     rate [56%: Asilian 2004]. However, this therapeutic approach has been used for L braziliensis     from Brazil, with an attractive cure rate after 3 months of 80% [Oliveira-Neto 1997]. Because     intralesional Sb injections is the local therapy with the best reported cure rate for South     American L braziliensis disease, the species that causes disease in Bolivia, this pilot study     of local therapy for bolivian L braziliensis disease will evaluate intralesional Sb therapy.   "
151487|NCT01300962|"     This phase I study has been designed to establish the safety, tolerability and maximum     tolerated dose (MTD) of four separate regimens for patients with metastatic breast cancer:     dose- escalating BKM120 when combined with capecitabine (Arm A), with capecitabine and     trastuzumab (Arm C), or with capecitabine and lapatinib (Arm D) and dose- escalating BEZ235     when combined with capecitabine (Arm B).   "
151488|NCT01300949|"     The Spaeth-Richman Contrast Sensitivity (SPARCS) test is a new method of assessing contrast     sensitivity. The test is performed on any standard computer with internet access. Patients     will be tested with SPARCS and with the standard Pelli-Robson contrast test.   "
151489|NCT01300936|"     The purpose of this study is to measure abdominal wall strength both preoperatively and     postoperatively in patients undergoing ventral/incisional hernia repairs. The investigators     hypothesize that abdominal wall strength is improved in hernia repairs that reapproximate the     rectus musculature to the midline. Abdominal wall strength measurements would be obtained     utilizing various abdominal strength testing.   "
151490|NCT01300923|"     Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS     is inherited from the carrier parent, most often the mothers. FXS is associated with severe     interfering behavioral symptoms which include anxiety related symptoms, attention deficit     hyperactivity, and aggressive behaviors. Approximately 25-33% of individuals with FXS also     meet criteria for autistic disorder. The hypothesis of this study is that treatment with     acamprosate will reduce inattention/hyperactivity, language impairment, irritability, social     deficits, and cognitive delay in youth with FXS. The purpose of this study is to investigate     the effectiveness and tolerability of acamprosate in youth with Fragile X Syndrome and to     assess the potential psychophysiological differences between FXS and autism spectrum     disorders.   "
151491|NCT01300910|"     This is a randomized control trial of 400 adult male circumcision procedures with a one to     one ratio between Shang Ring and the in-country standard surgical technique (forceps guided     in Kenya and dorsal slit in Zambia).   "
151535|NCT01300325|"     Acute bronchiolitis is the main cause for respiratory illness that requires hospitalization     in children younger than 2 years. In the United States it has been shown that the burden of     the disease is considerable, having an annual cost of more than $ 500 million and being     responsible for the 17% of all infant hospitalizations . Aim of the present study was to     verify the effects of nebulized 3% saline solution in comparison to normal saline in     addiction to epinephrine in a large population of RSV positive cases of bronchiolitis; all     patients presented a disease as much as severe to require hospitalization.The main study     endpoints were the length of stay in hospital and the clinical response.   "
151493|NCT01300884|"     Hypotheses: High definition manometry (HDM) is safe and feasible in humans; HDM accurately     characterizes anorectal anatomy and function in healthy humans; HDM provides comparable     information regarding the structure and function of the anorectal region, to that obtained     from ano-rectal manometry and anal ultrasonography (AUS), in patients with fecal incontinence     or constipation.      Methods: 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with     constipation will be recruited. Because anorectal disorders are more common in women, the     investigators will recruit approximately 8 men and 12 women in each group. Each subject will     undergo anorectal manometry, anal ultrasound and high definition manometry.      Data Analysis: Spearman correlational analysis will be performed to compare the parameters     listed above. Also, the diagnostic yield of anal ultrasonography vs HDM in identifying     anatomic sphincter defects will be assessed.   "
151494|NCT01300871|"     This is a study to determine the prevalence and severity of alopecia (hair loss) experienced     by postmenopausal breast cancer patients receiving endocrine therapy including Tamoxifen,     Letrozole (Femara), Exemestane (Aromasin), or Anastrozole (Arimidex).   "
151495|NCT01300858|"     Colorectal cancer may be caused by a build-up of genetic defects, or damaged genes within the     body's cells. When genes are damaged, the body may be unable to produce a group of proteins,     called cytokines, used by the immune system to fight cancer and some infections. The     investigational gene transfer agent EGEN-001 contains the human gene for the cytokine     interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the     body to produce cytokines.Therefore Therefore, the purpose of the EGEN-001 therapy is to     attempt to enhance the body's natural ability to recognize and fight cancer cells.   "
151496|NCT01300845|"     In France, the most used humidifying system during oxygen therapy is a non heated device with     weak efficiency and non-proven clinical benefits. This study aims to assess the lack of     benefits of non-heated humidification compared to no humidification, as regards to the     comfort of the patient receiving oxygen therapy.   "
151497|NCT01300832|"     The study's hypothesis is that there are some patients who come for surgery who have     asymptomatic clots in their lower extremities upon their arrival to the hospital for their     surgical admission. We will be performing duplex studies of the subjects' legs before their     surgery to determine how often clots are present. We will also perform duplex scans of the     legs after the subjects' surgeries to determine what factors (surgical, anesthetic,     co-morbidities)are correlated with the development of DVTs.   "
151498|NCT01300819|"     The primary objective of this study was to demonstrate that Rotigotine improves non-motor     symptoms compared to Placebo in subjects with Parkinson's Disease.   "
151499|NCT01300806|"     The goal of this research is to assess the impact of the screening, brief intervention, and     referral to treatment (SBIRT) intervention strategy for harmful substance use among     HIV-positive people.   "
151500|NCT01300793|"     Primary objective of the study is to determine the maximum tolerated dose (MTD) of bortezomib     (Velcade) in combination with rituximab, ifosfamide, carboplatin and etoposide for adult     patients with relapsed or refractory aggressive B-cell lymphoma. The secondary objectives are     to assess the tolerability and safety, the response rate, rate of autologous stem cell     transplant and CD34+ progenitor cell collection and engraftment after treatment with this     regimen.   "
151501|NCT01300780|"     Perhaps the use of a more selective anti-inflammatory drug, capable of inhibiting enzyme     specific for pain may be more effective in preventing the tooth sensitivity caused by the     inflammatory response produced by in-office bleaching. To the extent of the authors´     knowledge, no study has so far addressed the use of a selective anti-inflammatory drug     specific for pain enzyme on tooth sensitivity, being this the aim of the present     investigation.   "
151502|NCT01300767|"     The purpose of this study is to compare the performance of two commercially marketed contact     lenses when worn for up to 4 weeks in a daily wear modality.   "
151503|NCT01300754|"     Objective: To examine the potential of dextrose injection versus lidocaine injection versus     supervised usual care to change pain/function/activity levels in adolescent athletes with     Osgood-Schlatter Disease (OSD).   "
151504|NCT01300741|"     The purpose of this study is to compare the performance of two commercially marketed contact     lenses when worn for up to one month in a daily wear modality.   "
151505|NCT01300728|"     Patients with mild cognitive impairment (MCI) are a group recognized at being at high risk of     progressing to Alzheimer disease. Treatment of MCI with immunotherapy with intravenous     immunoglobulins (IVIG) could potentially reduce the risk of progression to Alzheimer disease.      This study will evaluate the efficacy of intravenous immunoglobulin in patients with MCI over     24 months after the first infusion. This study will also document conversion from MCI to     Alzheimer's Disease.   "
151506|NCT01300715|"     In spite that variable techniques for lumbar MBRF exists, the tunnel vision technique is     widely recommended for exact radiofrequency needle placement. However, this method uses the     concept of a steep caudocephalad axial tilt of the fluoroscopy beam, which result in unusual     appearance of vertebral structures and a long distance from skin to the target site. In our     institution, therefore, the investigators have used a modified method that is easy and safe     to place RF needle parallel to the lumbar medial branch in oblique fluoroscopic view.      Accordingly, our objectives were to evaluate our modified technique for lumbar MBRF,     comparing with the tunnel vision technique, and additionally to assess complications with     respect to these two techniques.   "
151507|NCT01300702|"     Investigation of thermal thresholds and sensory mapping to thermal stimuli   "
151508|NCT01300689|"     This is a observational study aims to assess anal and genital human papillomavirus (HPV)     infection status among men who have sex with men (MSM) in China, and their knowledge and     attitude about HPV vaccine.   "
151509|NCT01300676|"     Despite evidence supporting the benefits of hormone replacement therapy (HRT), only 15% of     postmenopausal women currently use HRT (1). The leading reasons why women refuse or     discontinue HRT are fear of malignancy, side effects such as vaginal bleeding, weight gain,     depressed mood, and breast tenderness, and social reasons such as regarding menopause as a     natural transition, not as a disease that requires treatment. Millions of women expressed     their concern on the safety of hormone replacement therapy since the data from the Women's     Health Initiative (WHI) study was released, which reported an increased risk of     cardiovascular disease, breast cancer, stroke and thromboembolic disease with conjugated     equine estrogen plus medroxyprogesterone acetate compared with placebo (2). The study has     also demonstrated that quality of life (3) and cognition (4) were no better in the HRT group     than the placebo group. In view of these problems, women are increasingly turning to     alternative therapies in an effort to manage their menopausal symptoms (1).      Menopause is associated with decreasing sex steroid levels. The effect of menopause on     circulating androgen levels has been studied by several investigators with variable findings.     The levels of testosterone and androstenedione appear to show a small but significant     decrease just before or within the first 2 years after menopause, with a decrease in     testosterone amounting to approximately 15% (5,6). Unlike the abrupt decrease in estradiol     levels associated with menopause, circulating testosterone, DHEA, and DHEAS levels decrease     more gradually, beginning in the years before menopause and continuing thereafter (6,7). As a     consequence, some women may experience symptoms of androgen decrease in the period before     cessation of menses. By giving Tualang Honey to these postmenopausal women, it is postulated     that the symptoms of androgen deficiency or menopausal symptoms should be reduced.      The investigators have also reported that tualang honey given to ovariectomised rats, an     animal model for postmenopausal states for two weeks significantly increased the free     testosterone and progesterone plasma levels, but no significant effect was seen in the     beta-estradiol level. There were significant increased in the thickness of vaginal epithelium     and vaginal epithelial-muscular layers. Proliferation of the squamous epithelium with     vacuolation of some of the squamous cells were noted in the honey treated animals implying     that there were increased in mucopolysacharide content. Uterine weight, endometrial and     circular muscle thickness were significantly increased in honey treated animal with cystic     changes noted over the glands (8).      To date, there are no clinical studies looking at the effects of Tualang Honey on     perimenopausal women. In view of the initial evidence that it is a phytoestrogen from animal     studies and has androgenic properties as well, it should have a beneficial effect to these     women in terms of improvement in their menopausal symptoms, changes in their endogenous     hormonal profile and increase in bone mineral density.   "
151536|NCT01300312|"     The purpose of this study is to investigate the effects of a fixed dose combination of     diclofenac and eperisone hydrochloride compared with plain eperisone hydrochloride in     patients with low back pain.   "
151537|NCT01300299|"     This trial will test the feasibility of adjuvant chemotherapy after stereotactic body     radiation therapy for early stage non-small cell lung cancer (NSCLC).   "
151709|NCT01298024|"     The purpose is to study the effect of early NEuroMuscular EXercise (NEMEX) versus     conventional treatment (late exercise) in patients with acute non-operative achilles tendon     rupture (ATR).   "
151510|NCT01300663|"     Post-surgery complications in women with vulvar neoplasms (vulvar intraepithelial neoplasia     and vulvar cancer) are still high and an instrument assessing patients self-reported     post-vulval surgery symptom experiences is missing. The study aims to develop and validate a     postoperative instrument to assess symptom experiences in women with vulvar neoplasms. In     this mixed-method project 20 patients were interviewed, a WOMAN-PRO instrument was developed     and content validity was tested by 6 experts and 10 patients. The instrument's psychometric     properties and the prevalence of symptoms will be examined in a cross-sectional study in the     University Hospitals Munich, Freiburg, Berlin, Düsseldorf, Zurich, Basel, Berne, and the     Cantonal Hospital St. Gallen (N=150). The goal of this project is that symptom assessment     becomes a standard component of clinical practice (to promote the early detection and     treatment of symptoms) and research.   "
151511|NCT01300650|"     This is an open-label, non-randomized, pilot-study to evaluate the effect of Interleukin-1     blockade on exercise capacity in patients with heart failure. Subjects will undergo     cardiopulmonary exercise testing at baseline and after 2-weeks treatment with anakinra     (recombinant human Interleukin-1 receptor antagonist).   "
151512|NCT01300637|"     Background: Several studies have suggested that clozapine has the greatest propensity of all     available atypical antipsychotics to induce weight gain and metabolic dysregulation. So it is     necessary to conduct some interventions to prevent or treat metabolic dysregulation induced     by clozapine.      Metformin has been reported to achieve weight loss in several groups of patients     characterized by insulin resistance. Several studies evaluated the effects of metformin on     antipsychotics-induced weight gain and study period lasted from 8 to 16 weeks. Long-term     metformin use had more robust effect on metabolic dysregulation and body weight in     non-psychiatric field.      Goals: The study goals are two-fold. The first goal is to estimate the prevalence of     metabolic dysregulation among clozapine-treated schizophrenic patients in Taiwan. The second     goal is to assess the reversal effect of metformin on metabolic disturbance among     clozapine-treated schizophrenic patients in a 24-week double-blind, placebo-control trial.     The investigators will use metformin 1500 mg/d or placebo in the second phase trial.      Methods: This study will be divided into two phases. The first phase is to estimate the     prevalence of metabolic disturbances among clozapine-treated patients. The second will be a     randomized, double-blind, and placebo-controlled study of adjunctive metformin for non-DM     clozapine-treated patients.      The clozapine dosage was maintained unchanged during the study period. The eligible patients     will be randomly assigned to either metformin or identical placebo pills. Metformin will be     titrated to 1500 mg/day in 4 weeks. Patients' blood pressure (BP), waist circumference, body     weight, fasting plasma glucose (FPG), triglyceride (TG), high-density lipoprotein cholesterol     (HDL), insulin, and leptin will be measured at 2, 4, 8, 16, and 24 weeks after the start of     metformin.      In a 3-year period, the investigators estimate to recruit 150 clozapine-treated patients in     the first phase and 75 fulfill the second phase criteria. The investigators estimate 60     patients complete the second phase intervention (staying in second phase at least 4 weeks).      From this study, the investigators would like to know the prevalence of metabolic     dysregulation among clozapine-treated schizophrenic patients and to know the effect of     metformin on metabolic profile among non-DM clozapine treated patients.   "
151513|NCT01300624|"     The purpose of this study is to evaluate the effect of Verb Network Strengthening Treatment     (VNeST) on the ability to produce sentences and connected speech in persons with aphasia.   "
151514|NCT01300611|"     The purpose of this study is to evaluate the effect of TXA127 on neutrophil and platelet     counts in adult patients who have undergone a double cord blood transplant. The study will     also evaluate the effect of TXA127 on chemotherapy-induced mucositis, an inflammation of the     mucous membranes in the digestive tract (mouth to anus) and immune reconstitution which helps     patients fight infections. For patients undergoing CBT, both neutrophil and platelet     normalization and immune reconstitution can be delayed. TXA127 has shown to be well tolerated     by patients and appears to induce a rapid production of neutrophils and platelets in the     bloodstream as well as increase the immune system components. It has also been shown to     reduce the severity of chemotherapy-induced mucositis.   "
151515|NCT01300598|"     The purpose of this study is to investigate the efficacy and safety of autologous     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with     degenerative arthritis.   "
151516|NCT01300585|"     The purpose of this study is to test a new method of defining patterns of how breast glands     are or are not attached to the overlying skin. All patients will have markers placed on both     breasts and will undergo an MRI. MRI results will be examined to identify the pattern of     breast gland attachment to the overlying skin. This will help identify patients which may     benefit from areolar sparing and/or nipple sparing technique and which patients should be     treated by standard mastectomy.   "
151517|NCT01300572|"     This phase I trial studies the side effects and maximum tolerated dose of yttrium Y 90     anti-cluster of differentiation 45 (CD45) monoclonal antibody BC8 (90Y-BC8) followed by donor     stem cell transplant in treating patients with acute myeloid leukemia (AML), acute     lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) that is likely to come back     or spread. Giving chemotherapy drugs, such as fludarabine phosphate (FLU), and total-body     irradiation (TBI) before a donor peripheral blood stem cell (PBSC) or bone marrow transplant     helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system     from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies, such as 90Y-BC8,     can find cancer cells and carry cancer-killing substances to them without harming normal     cells. When the healthy stem cells from a donor are infused into the patient they may help     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Sometimes the transplanted cells from a donor can make an immune response against the body's     normal cells. Giving FLU, 90Y-BC8, and TBI before the transplant together with cyclosporine     and mycophenolate mofetil after the transplant may stop this from happening.   "
151518|NCT01300559|"     The overall objective of the investigators research is to test the clinical efficacy of the     TissueLink™ (Salient Surgical Technologies, Inc.) coagulation system in minimizing hemoglobin     loss intraoperatively. This is a prospective, randomized investigation that will be performed     at Duke University Medical Center (DUMC). The overall goal of this study is to evaluate the     efficacy of Tissue Link HemoSealing system in minimizing hemoglobin loss preoperatively,     intraoperatively and postoperatively for patients undergoing multilevel elective spinal     surgery. Not greater than eighty patients scheduled for elective, multi-level decompression     and fusion spinal surgery with Dr. William Richardson will be randomized into two groups.     Unipolar electrocautery will be used for intraoperative coagulation in one group and the     Tissuelink device plus Unipolar electrocautery in the other. These are frequently performed     cases with significant blood loss but otherwise low morbidity/mortality that would benefit     from more effective intraoperative coagulation.   "
151519|NCT01300546|"     This study is being conducted to evaluate the hypothesis that use of pharmacological and     non-pharmacological interventions may allow subjects at high risk for chronic migraine to     avoid or reverse the transformation of episodic migraine to chronic migraine.   "
151520|NCT01300533|"     The goal of this Phase 1 clinical research study is to find the highest safe dose of BIND-014     that can be given in the treatment of patients with advanced or metastatic cancer.   "
151521|NCT01300520|"     The current method of incision localization in many surgical procedures requires a doctor to     reference a medical image, such as an X-ray, to judge where on the body an incision should be     made. However, the precise information of the scan is not shown on the patient's skin.     Surgeons commonly use palpation to locate the point of incision. They may feel for the area     directly or find landmarks under the skin and estimate the location from there. The following     factors further complicate palpation: overweight patients, foreign bodies that are difficult     to feel for under the skin, fractures with little displacement, or locations under dense     muscles. These difficulties are compounded for new surgeons, since palpation is a skill     derived through experience.      In many circumstances the surgeon only needs to know where to insert the tool or place the     incision - they do not necessarily need to know the depth of the area of interest. If     palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the     fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer     to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and the     patient to radiation. Many fluoroscopic images may be required in a single procedure.      By identifying the efficacy of this new medical device, Target Tape, there is the potential     outcome of making smaller incisions, faster localization, a reduction in fluoroscopy use and     a reduced chance in surgical error and the associated costs.      Target Tape is a non invasive device that is in a grid or ruler format that is placed against     the subject's skin. The grid/ruler pattern will then appear on the medical imaging scan.     Standard surgical skin ink is then used to place these markings in a defined pattern on the     skin. This pattern mimics the Target Tape grid or ruler pattern. The medical practitioner can     correlate these skin markings to the medical scan image to make their incisions in more     accurate locations.   "
151522|NCT01300507|"     The PRESTIGE-registry is a joint effort at 9 European heart centers to collect data regarding     patients presenting with stent thrombosis in a dedicated database. There will be extensive     clinical and procedural characterization, furthermore blood platelet function testing,     intracoronary imaging, DNA-sampling and analysis of thrombus aspiration will be performed.   "
151523|NCT01300494|"     An optimal angiographic viewing angle is critical for correct diagnosis and intervention in     coronary bifurcation lesion percutaneous coronary interventions (PCI). The current study aims     at validating a dedicated software tool (MEDIS, Leiden, The Netherlands) that will improve     the selection of the best viewing angle.   "
151524|NCT01300468|"     The purpose of this open-label, multi center, Phase I study was to determine the safety     profile of the oral compound PHA-848125AC administered according to two different schedules     of administrations to advanced/metastatic solid tumor patients. Objectives of the study were     to determine the maximum tolerated dose and the dose that can be recommended for Phase II     investigations.   "
151525|NCT01300455|"     This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant     (MK-4305) on respiratory function in participants with mild to moderate obstructive sleep     apnea (OSA) compared to administration of placebo. The primary hypothesis of this study is     that multiple doses of MK-4305 do not produce a clinically significant increase in     Apnea-Hypopnea Index (AHI) in participants with mild to moderate OSA, as compared to placebo.   "
151526|NCT01300442|"     Transcutaneous electrical diaphragmatic stimulation (TEDS) has been used to improve     respiratory muscle strength in patients with respiratory muscles weakness. However, this     physiotherapeutic resource has not been studied in chronic obstructive pulmonary disease     (COPD) yet. The objective of this study is to evaluate the respiratory pattern during the     session of TEDS besides its effect in respiratory muscle strength and in spirometric     variables as much healthy patients as in COPD patients. Methods: healthy and COPD patients     are selected and submitted to TEDS treatment. The plethysmographic analysis (LifeShirt System     - VivoMetric), respiratory muscle strength and spirometry will be made. The hypothesis is     that the TEDS can helps COPD patients that shows respiratory muscle weakness.   "
151527|NCT01300429|"     The purpose of this study is to try to learn more about how small molecule kinase inhibitor     medications work in treating lung cancer. Crizotinib (PF-02341066) is a drug that has been     shown to shrink tumors in some patients with lung cancer. While the investigators know how     this drug works to stop the growth of tumors that depend on change in the gene named ALK     (also called EML4-ALK), the investigators do not know why the drug stops working. The     investigators would like to examine the tumor to help us better understand why crizotinib has     stopped working as well as it once did. The tumor will be examined with multiple tests to     look for the reason that crizotinib stopped working.   "
151528|NCT01300416|"     This study will access the GI complaints on patients reported outcomes and to determine the     improvement in quality of life in patients.   "
151529|NCT01300403|"     This study aimed to evaluate the acute physiological effects of expiration with the glottis     open in lateral posture (ELTGOL) and Flutter valve in dynamic and static lung volumes in     patients with bronchiectasis and, secondarily, to study the effect of these techniques in     sputum production.   "
151530|NCT01300390|"     The overall hypothesis is that endothelial function, apolipoprotein levels and adiponectin     levels are accurate predictors of underlying cardiovascular disease in patients with     end-stage liver disease, in whom standard tools for the diagnosis of and screening for     cardiovascular disease are of limited utility.   "
151531|NCT01300377|"     The goal of the proposed study is to investigate the relationship between two standard     treatments, lidocaine or a mixture of lidocaine and bupivacaine, and 1) postoperative pain,     and; 2) narcotic use following pacemaker or defibrillator insertion in subjects who undergo     arrhythmia surgery at Baylor Heart and Vascular Institute while adjusting for pertinent     clinical and/or demographic factors. No control group is necessary.   "
151532|NCT01300364|"     Main objective: To assess the efficacy of two antidepressants of different pharmacological     families: citalopram (Selective serotonin reuptake inhibitors, SSRI) and reboxetine     (Norepinephrine Reuptake inhibitor, NRI) as adjunct treatments to risperidone and olanzapine     for the treatment of negative symptoms of schizophrenia.      Secondary objectives: To assess the efficacy of citalopram and reboxetine as adjunct     treatments to risperidone and olanzapine for the treatment of cognitive symptoms of     schizophrenia. To compare the efficacy of reboxetine and citalopram as adjunct treatments for     the treatment of negative and cognitive symptoms of schizophrenia.      Method: Multicentric, randomized double-blind clinical trial compared to placebo with a six     months follow-up. A total of 249 patients with a diagnosis of schizophrenia (DSM-IV criteria)     and significant negative symptoms, will be recruited in the 9 participating centres.     Variables: sociodemographic and clinical variables (PANSS, SANS, CGI global, GAF,LSP,     Hamilton scale, BACS)   "
151533|NCT01300351|"     The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with     the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive     advanced breast cancer who have failed a prior endocrine treatment.   "
151534|NCT01300338|"     Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a     primary care practice?   "
151541|NCT01300247|"     This open-label, 2-arm, nonrandomized, multicenter, Phase Ib study will investigate the     safety and efficacy of obinutuzumab (RO5072759; GA101) administered in combination with     chemotherapy (bendamustine or fludarabine + cyclophosphamide [FC] regimens) in participants     with previously untreated cluster of differentiation 20 (CD20)-positive B-CLL. Participants     will be enrolled to receive a maximum of 6 cycles of obinutuzumab (1000 milligrams [mg]     intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 - 6) plus     bendamustine (90 milligrams per meter square [mg/m^2] IV, on Days 2 and 3 of Cycle 1 and Days     1 and 2 of Cycles 2 - 6) on 28 day cycles or a maximum of 6 cycles of obinutuzumab (1000 mg     IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 - 6) plus FC (fludarabine     25 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2 - 6;     cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2     - 6) on 28 day cycles.   "
151542|NCT01300234|"     This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate     the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This     study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating     Chinese subjects with CHB (hepatitis B e antigen [HBeAg] positive subjects and HBeAg negative     subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF     300 mg administered once daily.   "
151543|NCT01300221|"     The propose of this study is to generate normative data of the tree-dimensional     echocardiographic(3-DE) measurements for cardiac structure and function in a large cohort of     normal infants, children,and adolescents. The investigators also sought to investigate the     utility of 3-DE in evaluating infants, children and adolescents with congenital and acquired     heart diseases.   "
151544|NCT01300208|"     This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety,     tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.   "
151545|NCT01300195|"     Prospective cohort study of factors predisposing to persistent post surgical pain after     video-assisted thoracic surgery   "
151546|NCT01300182|"     To investigate the effect of early WBVT on neuromuscular control after ACLR.   "
151547|NCT01300169|"     This is a randomized controlled trial comparing the use of new clinical intervention (the     Collaborative Assessment and Management of Suicidality--CAMS) versus enhanced care as usual     for suicidal Soldiers who are seen at outpatient mental health clinics at Ft. Stewart GA.   "
151548|NCT01300156|"     The purpose of this study is to evaluate the efficacy and safety of combination chemotherapy     with etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin (ESHAOx) for     patients with refractory or relapsed Hodgkin's lymphoma (HL).   "
151549|NCT01300143|"     Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose     total tumor mass can technically be irradiated, non-resectable, and not a candidate for     percutaneous therapy with recommended treatment via hyperselective transarterial     chemoembolisation (TACE).   "
151550|NCT01300130|"     The investigators examined the effect of different levels of docosahexaenoic aicd (a long     chain polyunsaturated fatty acid) intake on the fatty acid composition of plasma and     erythrocyte phospholipids and on the maturity of visually evoked potentials in preterm     infants. As a secondary outcome the conversion of linoleic acid and alpha linolenic acid into     their corresponding long chain polyunsaturated fatty acids was studied.      Preterm infants were randomized in a double-blind fashion to one of three formulas containing     different amounts of docosahexaenoic acid during the first two weeks of postnatal life. A     control group received human milk. Blood samples were collected at study entry and 14 and 28     days thereafter. Uniformly 13C-labeled linoleic acid and alpha linolenic acid were applied     orally before blood sampling at day 28. At postconceptional ages 48 weeks and 56 weeks     visually evoked potentials were recorded.   "
151551|NCT01300117|"     The purpose of this study is to determine whether extracorporeal circulation during cardiac     surgery has an influence on ADAMTS13-Activity.   "
151552|NCT01300104|"     PURPOSE:      To evaluate the feasibility of a future Nordic intervention trial, including vigorous     activity and a high intake of whole grain rye, among prostate cancer patients on active     surveillance.      Additionally, to investigate effects of the lifestyle intervention according to cancer     progression, the metabolic profile, inflammation and quality of life among prostate cancer     patients on active surveillance.   "
151553|NCT01300091|"     Consumption of medical care and outcome of shoulder pain and disability in primary care.   "
151554|NCT01300078|"     This Phase 1, open label, randomized clinical trial will enroll 40 generally healthy,     postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses     of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United     States.   "
151555|NCT01300052|"     The purpose of this study is to determine whether AN2728 topical ointment is a safe and     effective treatment for mild-to-moderate plaque-type psoriasis.   "
151556|NCT01300039|"     The investigators are finding out if giving antibiotics for Helicobacter pylori will     eliminate colonization of the colon by Oxalobacter formigenes.   "
151710|NCT01298011|"     The main purpose of this research study is to evaluate whether Abraxane and gemcitabine are     effective in treating patients with operable pancreatic cancer.   "
157210|NCT01225965|"     To investigate the physical inflammation inhibition effects of EIL (Ectoin-Hydro-Complex) in     subjects of the established SALIA-cohort and the preventive effects on lung function decline.   "
151558|NCT01300013|"     The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV)     omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular     systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized,     double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of     ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to     omecamtiv mecarbil or placebo.   "
151559|NCT01300000|"     The primary objective of the study is to compare the growth of infants fed standard infant     formula with infants fed a reduced calorie and protein formula.   "
151672|NCT01298531|"     This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of     etanercept with that of placebo in adult subjects with axial Spondyloarthritis.   "
151560|NCT01299987|"     This prospective, multicentric single arm phase II study is based on the protocol of the     international TARGIT-A study. The purpose is to investigate the efficacy of a single     intraoperative radiotherapy treatment within elderly low risk patients (≥ 70 years, cT1, cN0,     cM0, invasive-ductal) which is followed by WBRT only when risk factors are present. In     presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic     treatment according to international guidelines.   "
151561|NCT01299974|"     The study seeks to implement and test a novel approach to teach pediatric residents about     patient and family-centered care (PFCC). The approach calls for a supervised meeting between     a family member of a previously hospitalized child and a resident in the context of a     pediatric residency rotation.   "
151562|NCT01299961|"     Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing     pain and swelling) associated with significant health problems. It is a difficult disease to     manage as the disease is often unpredictable. RA causes inflammation (swelling) of the joints     that can cause joint damage, deformity, and progressive disability and impairment. It is     estimated that 1% of the world's population suffers from this disease.      The purpose of this research study is to determine if a change in inflammation seen on the     ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to     treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months.   "
151563|NCT01299948|"     There has been reports that low dose prednisolone stabilizes CD4-counts in HIV infected     individuals. However, until now, there are no prospective randomized studies on the use of     corticosteroids in latent HIV disease. Furthermore, low dose prednisolone (5 mg/d) is not     sufficient tested for the risks and benefit for HIV patients especially for those living in     poor settings with a higher risk of infections. This study will assess the benefit and the     safety profile for low dose prednisolone therapy for patients in a region with limited     resources and high prevalence of infections.   "
151564|NCT01299935|"     This randomized controlled clinical trial tests the hypothesis that a selected stress     reduction approach, the Transcendental Meditation program will reduce all-cause mortality,     myocardial infarction and stroke in African American patients with coronary heart disease.     Secondary hypotheses include effects on other cardiovascular clinical events, blood pressure     and psychosocial stress.   "
151565|NCT01299922|"     The treatment of lupus nephritis with cyclophosphamide and steroids changed the prognosis of     lupus nephritis in the early '80s. In recent years, alternative regimens have appeared in     both the induction and maintenance with similar results at least to those offered by the     classic pattern and possibly with fewer side effects, especially for long term. The     association of prednison and mycophenolate has created large expectations to that effect, and     is part of first-line therapeutic arsenal of lupus nephritis type III, IV and V.      Despite the significant advances that have led to these treatments, the likelihood of     complete remission after six months remains, according to the series of 8-13% and partial     remission do not exceed 60% in papers published. In the last year, two articles have been     published supporting the use of triple therapy (prednisone, mycophenolate, cyclosporine) in     poor prognosis of lupus nephritis with hopefully better results than those obtained     previously. In this study we try to compare the effectiveness of triple therapy, the therapy     is now considered standard (prednisone, mycophenolate) in patients with lupus nephritis type     III-IV-V   "
151566|NCT01299909|"     The MTS2 study enrollment goal is N=240 adult smokers randomized to study treatments. The     study design includes two randomized arms to compare matched intensive interventions and a     third non-randomized option for participants who prefer not to enter an intensive     intervention. It is expected that roughly 50% (120) will choose to be in the randomized     intensive interventions and 50% (120) will choose to be in the non-intensive intervention.     Participants who choose to be in an intensive intervention will be randomized to either     Mindfulness Training for Smokers(MTS) (n = 60) or Integrated Training for Smokers     (ITS)(n=60). Both MTS and ITS are smoking cessation interventions that provide 8 classes over     a 6-week period and 2 weeks of nicotine patches. MTS provides and training in mindfulness     whereas ITS provides training in quit smoking strategies and access to the Freedom From     Smoking Online Premium Program. Participants who choose to be in a non-intensive intervention     (estimated from prior recruitment data at n=120) will receive a phone-based intervention     through the Wisconsin Tobacco Quit Line and 2 weeks of nicotine patches.   "
151567|NCT01299896|"     The purpose of this research study is to examine the effectiveness of an intervention     designed to reduce smoking in low income veterans within a regional United States Veterans     Administration(VA) health care system. A proactive, personalized, coordinated system of care     Connect to Quit (CTQ) is rooted in the Chronic Care Model. CTQ treats smoking as a chronic     condition, like hypertension or diabetes, that requires long term treatment with appropriate     combinations of behavioral therapy and pharmacotherapy. CTQ will be evaluated in the context     of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.   "
151597|NCT01299506|"     This is an observational, non-randomized, open label, multicenter, phase IV study, which aims     to reflect a real-life practice routinely used for the management of advanced soft tissue     sarcoma after failure of anthracyclines and/or ifosfamide or patients unsuited to receive     these drugs in the Netherlands. This study pretends to reflect the use and schedule of     chemotherapy regimen with trabectedin and/or other conventional care regimens such as other     palliative chemotherapy/biological therapies or best supportive care (BSC) in the management     of advanced soft tissue sarcoma patients in the clinic based at the discretion of the     Investigator.      There are no pre-defined limits of administered cycles of trabectedin treatments or chemo-     and/or biological therapy; thus, those treatments may continue as long as deemed necessary by     the Investigator   "
151604|NCT01299415|"     This trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an     inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The     purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and     ASA404. The purpose of the Extension Phase is to provide continued treatment for those     patients that have not progressed during the Core Phase and to collect safety data on ASA404     when given in combination with paclitaxel, docetaxel or the paclitaxel plus carboplatin     chemotherapy regimen.   "
151605|NCT01299402|"     The purpose of the study was designed to evaluate the efficacy and safety of Soulera herbal     mix in powder form and its effects on anxiety and the biomarkers for chronic stress.   "
151568|NCT01299883|"     The investigators will evaluate the effects of an integrated risk counseling program on     behavioral and psychological outcomes in African American men and women in a randomized trial     that is implemented and evaluated collaboratively through the West Philadelphia Consortium to     Address Disparities. The specific aims of this research are as follows:        1. To evaluate the effects of integrated versus disease specific counseling on risk          exposure behaviors. The investigators predict that compared to individuals who receive          disease specific counseling, those who receive integrated counseling will report greater          intake of fruits and vegetables and increased rates of physical activity.        2. To evaluate effects of integrated versus disease specific counseling on psychological          outcomes. The investigators predict that compared to individuals who receive disease          specific counseling, those who receive integrated counseling will report greater risk          comprehension related to cancer and cardiovascular disease and will be more motivated to          make behavioral changes.        3. To identify the mechanisms through which integrated risk counseling leads to behavioral          change. The investigators predict that changes in risk exposure behaviors (e.g., diet          and physical activity) will be mediated by increased risk comprehension and          self-efficacy for diet and physical activity.   "
151569|NCT01299870|"     Epilepsy is a disorder in the brain. The brain is full of nerve cells. Nerve cells have     normal electrical activity to control the many functions of the body. Sometimes nerve cells     do not function normally due to many different reasons such as disease, an injury or because     the brain didn't develop normally at birth. When nerve cells do not function normally the     electrical activity that controls things like muscles and body movement can get mixed up and     cause seizures. When a seizure occurs, sometimes a person loses control of body movement,     and/or bodily functions. When a seizure occurs, a person may become unconscious, and/or     senses may be affected. Seizures can occur at any time, without warning, and can lead to many     health problems.      Catamenial epilepsy is specific form of epilepsy in women. It is closely related to the     menstrual cycle. In this form of epilepsy seizures increase around the menstrual period.      By doing this study, researchers hope to learn whether Keishibukuryogan add-on therapy with     antiepileptic drugs is safe for women with epilepsy.   "
151570|NCT01299857|"     The purpose of this study is to study the midterm clinical evaluation, biological parameters     and immune reconstitution after Rituximab treatment for Pemphigus.   "
151571|NCT01299844|"     The objectives of this study are:        -  To develop a comprehensive culturally tailored model of diabetes management that          integrates the work of community-based peer counselors and clinical specialists into a          multi-disciplinary health care team serving the Latino community.        -  To implement an intervention that provides education and support to Latino adults          diagnosed with Type 2 diabetes in both clinical and home settings.        -  To evaluate this intervention for its impact on program adherence, and improved outcomes          sustained over time as reflected by metabolic, clinical, cognitive and behavioral          measures.   "
151572|NCT01299831|"     The purpose of this study is to investigate signaling pathways in fat and muscle, as well as     turnover of protein, sugar and fat after stimulation with growth hormone and during fasting     in lean and obese subjects. This will help clarify differences in the human metabolism     between lean and obese subject and provide us with a better understanding of the molecular     mechanisms regulating the basic metabolism during prolonged fasting.   "
151573|NCT01299818|"     -  Pain is one of the most common concerns for which patients seek medical attention.        -  Pain is usually understood as symptom that reflects peripheral organic damage. Many          patients experience pain, often chronically, independently of any underlying cause such          as chronic regional pain syndromes (irritable bowel syndrome, temporo-mandibular pain          syndrome, chronic headache or chronic low back pain)or diffuse like in fibromyalgia. In          all those functional syndromes, accumulated evidence supports involvement of central          pain processing systems, hypothalamic pituitary adrenal axes and autonomic nervous          system, and are now referred as central pain conditions.        -  Other patients suffers from chronic pain caused by damage or inflammation in peripheral          tissues, but also experienced more diffuse pain, not directly explained by peripheral          damage, that further aggravates pain and function. This is illustrated by the high          prevalence of fibromyalgia observed in patients with rheumatoid arthritis,          osteoarthritis or ankylosing spondylitis for example.      These pain conditions are now understood as combinations of peripheral, neuropathic and     central pain.      The investigators aimed to focus in this study in patients that are candidates to spinal     surgery and suffer from low back pain and/or radiculopathy. Pain in these patients may arise     from damage to nerves - neuropathic pain- , to musculoskeletal structures - peripheral pain-,     and may also reflects alteration in central pain processes.      In these patients, spine surgery is usually performed to improve quality of life, decrease     pain and avoid neurological deficits. Evaluation of surgical outcome includes objective     measures such as neurological findings and radiographic evaluation, and subjective measures     including patient self-assessments for pain and quality of life and psychological changes.      The aim of this study is to evaluate patients who undergo spinal surgery for presence of     central pain and central sensitization symptoms and evaluate their influence on these     surgical outcomes   "
151574|NCT01299805|"     The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the     body), the pharmacokinetics (the body's handling of the drug), and the safety and     tolerability of vortioxetine, once daily (QD) in healthy men.   "
151575|NCT01299792|"     Video-urodynamic investigations are regarded as the current standard diagnostics for     neurogenic bladder dysfunction in patients with spinal cord injury. This examination is     exact, but time consuming, costly and associated with the risk of urinary tract infection.      In patients with lower urinary tract symptoms due to benign prostate hyperplasia, sonographic     measurement of bladder wall thickness has been demonstrated to be able to replace urodynamic     testing for the diagnosis of infravesical obstruction.      Hypothesis: measurement of bladder wall thickness in patients with neurogenic bladder     dysfunction due to spinal cord injury is closely related to the known risk factors for upper     urinary tract deterioration (bladder compliance, detrusor leak point pressure) in this group     of patients and can therefore replace urodynamic examination in selected cases.   "
151576|NCT01299779|"     Objective: To compare the incidence of peri-colonoscopy hyponatremia associated with PEG 3350     + sports drink (PEG-SD) versus PEG 3350-electrolyte solution + sodium sulfate + sodium     ascorbate and ascorbic acid (PEG-ELS).      Hypothesis: As compared to PEG-SD, hyponatremia occurs significantly less often with PEG-ELS.   "
151598|NCT01299493|"     Colorectal cancer is the second leading cause of cancer death and one of the most commonly     diagnosed malignancies. Screening is effective at reducing incidence and mortality from     colorectal cancer. This study will evaluate the effectiveness of implementing systems-changes     in community health centers that facilitate screening.   "
151711|NCT01297998|"     To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus     cisplatin combination therapy in patients with biliary tract cancer undergoing resection     without major hepatectomy.   "
151577|NCT01299766|"     The goal of this study is to determine whether increasing participation in cognitive,     physical, and/or social activities prevents cognitive decline in older African Americans     (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for     Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent     cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this     hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and     older) will be randomized to Behavior Activation (BA) (a behavioral intervention that     increases participation in daily activities) or Supportive Therapy (ST) (a person-centered     psychotherapy that involves active listening and offering support focusing on participants'     problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in     cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and     better quality of life than ST-treated subjects at 24 months.   "
151578|NCT01299753|"     Severe burn is associated with a wide array of stress, metabolic, and physiologic processes     in an attempt to restore homeostasis. The catecholamine induced stress response following     severe burns is particularly exaggerated and manifests detrimentally as inflammation, insulin     resistance, hypermetabolism, and associated profound protein catabolism. The investigators     hypothesize that catecholamine blockade will lead to restored IR signaling and result in     improved post-burn morbidity. The investigators will further determine the molecular     mechanisms mediating these effects.   "
151579|NCT01299740|"     Dialectical Behavioral Therapy (DBT) based skill groups for emotionally dysregulated children     and their parents      The investigators propose implementing a Dialectical Behavioral Therapy (DBT) skills group     format for emotionally dysregulated children between the ages of 8 and 12 and their parents.      Introduction Treatments available for children with emotional dysregulation and behavioral     problems were shown to be only partially effective.      DBT combines the western principles of changing behavior with the eastern principles of     acceptance and mindfulness.      Efficacy of DBT has been shown across a number of behavioral problems in adults and has been     successfully adapted for adolescents. The next logical step is modification for younger     children.      The investigators chose DBT because of the observed similarities between adults and     adolescents diagnosed with borderline personality disorder and the children who are referred     to the investigators clinic with emotional dysregulation.      Aims: To assess the ability to regulate emotions and problem behaviors before and after the     proposed intervention      Method:      Population: Between 6-10 children between the ages 8-12 will be recruited from The child and     adolescent psychiatric outpatient clinic at Soroka University Medical Center.      Inclusion criteria Children suffering from emotional dysregulation All children and at least     one parent speak Hebrew Exclusion criteria        1. Schizophrenia        2. Bipolar disorder        3. Psychosis i.e an overt thought disorder        4. Mental retardation        5. Severe learning disorders        6. Pervasive developmental disorders.        7. Children who have suffered brain injury.      Comparison group: Between 6 and 10 children matched for sex, parents age and education,     socioeconomic status that fulfill the same clinical criteria for inclusion in the study as     the study group. The comparison group will receive treatment as usual.      Procedure The children will participate in a group skills group over 20 sessions, each     session an hour and a half. The parents will participate in a group skills group over 15     sessions, each session an hour and a half. Each group will be lead by two therapists. All the     children will be evaluated by board certified child and adolescent psychiatrist and will be     diagnosed according to the DSM IV-TR. The parents' the child and a teacher who is familiar     with the child will fill in questionnaires before the beginning of the group, at the end of     the group process and 6 months after the group ends.      The treatment protocol will be based on Linehan's Skills training manual for treating     borderline personality disorder and on modifications made by Miller for adolescents. The     groups will be conducted according to a treatment manual which will be written accordingly     and modified in order to apply the skills to a younger population. Ancillary treatment ( e.g.     pharmacotherapy) will be provided on an as needed basis.      The control group the data will be collected at similar intervals to those in the study     group.      Written informed consent will be obtained from the child and a legal guardian.        -  ‬        -  ‬   "
151580|NCT01299727|"     Sanfilippo syndrome, or Mucopolysaccharidosis (MPS) III, is a rare lysosomal storage disease     (LSD) caused by loss in activity of 1 of 9 enzymes necessary for degradation of the     glycosaminoglycan (GAG) heparan sulfate (HS) in lysosomes. MPS IIIA results from deficiency     of the enzyme heparan N-sulfatase (sulfamidase). In the absence of this enzyme, intermediates     of the HS degradation process accumulate in the lysosomes of neurons and glial cells, with     lesser accumulation outside the brain. MPS IIIA symptoms arise on average at 7 months of age,     with the average age of diagnosis at 4.5 years for the majority of patients. Patients present     a wide spectrum and severity of clinical symptoms. The central nervous system (CNS) is the     most severely affected organ system in patients with MPS IIIA, evidenced by deficits in     language development, motor skills, and intellectual development. In addition, there are     abnormal behaviors including but not limited to aggression and excess motor     activity/hyperactivity that contribute to disturbances in sleep.Overall, individuals with MPS     IIIA have a marked developmental delay and significantly reduced lifespan to 15 years of age     on average.      The purpose of this study is to collect long term safety and tolerability data in patients     with MPS IIIA who previously received rhHNS in study HGT-SAN-055 (NCT01155778).   "
151581|NCT01299714|"     Researchers at The Ohio State University and the University of Michigan are working together     to understand cancer of the cervix. One of the areas they are studying is how stress you may     experience in your life effects the way you respond to GARDASIL®. GARDASIL® is a vaccine     approved by the Food and Drug Administration (FDA) to prevent some types of Human     Papillomavirus (HPV) infection which can cause cancer of the cervix. Participants are being     recruited from the Appalachian region of Ohio.   "
151582|NCT01299701|"     This study is designed to characterize the absorption, distribution, metabolism and excretion     (ADME) of ASA404 following a single intravenous administration of 3000 mg (approximately 1800     mg/m2) ASA404 containing 60 µCi of 14C over a period of 20 minutes in patients with advanced     solid tumors. Metabolic pathways, route (s) of elimination, distribution characteristics in     plasma and blood, and exposure characterization in plasma and blood, and exposure     characterization of the parent drug and metabolites will be obtained from the study.   "
151583|NCT01299688|"     The investigators propose to survey the frequency of HER2 (+) CTC in order to lay groundwork     for future clinical trials incorporating Her-2 targeted agents in gastric cancer.   "
151584|NCT01299675|"     The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of     the SureScan pacing system when used in an MRI environment according to product labeling.     This study is required by the Food and Drug Administration (FDA) as a condition of product     approval.   "
151599|NCT01299480|"     This study is to look at a new vaccine that might prevent meningococcal disease, and to look     at the safety of the new vaccine as well as how well it is tolerated. This study will also     look at this vaccine being given 2 or 3 times. This study will be done in healthy     adolescents.   "
151600|NCT01299467|"     The purpose of this study is to find out how long the effect of PF-03526299 last after it is     inhaled by assessing the lung function of mild asthma patients after they have been exposed     to allergen   "
151601|NCT01299454|"     The purpose of this study is to evaluate how much of the investigational product gets into     the blood stream and how long the body takes to get rid of it when given to subjects with a     range of liver impairment compared to subjects with normal liver function.   "
151585|NCT01299662|"     Vaccines induce protective immunity against numerous infectious diseases. However, current     vaccines have limited efficacy against challenging infections like tuberculosis, malaria, and     HIV. Protein vaccines are safe but, typically they induce weak T cell immunity when     administered alone. Therefore, special attention is being given to adjuvants, which are     enhancers of immunity, that cab mature antigen presenting immunostimulatory dendritic cells.     Our goal is to study in humans the mechanism whereby a synthetic adjuvant, poly ICLC, which     acts on defined pattern recognition receptors, enhances T an B cell immunity. In preclinical     studies, our lab has found in mice that poly IC and its analog poly ICLC are superior     adjuvants for T cell mediated immunity relative to other agonists for PRR. Poly ICLC has been     extensively studied in humans with a favorable safety profile. In a recently completed Phase     I study, poly ICLC was found to be safe and well tolerated when administered as a single dose     of 1.6 mg subcutaneously and intranasally to healthy volunteers. In additional, preliminary     data shows marked upregulation of gene expression in whole PBMSc following s.c. injection of     poly ICLC as well as activation of various blood cell type, including dendritic cells and     monocytes. In this study the investigators propose to extend the evaluation of innate immune     responses following s.d. injection of poly ICLC to healthy volunteers. The investigators     propose to characterize poly ICLC effects on specific blood cell types, focusing on three     different subsets of DC's, by analyzing gene transcriptional changes at baseline and at one     day following its administration. In order to study the early local effects of poly ICLC,     which are important for the recruitment and activation of antigen presenting cells, the     investigators also propose to perform skin biopsies at a skin site contralateral to the     injection site and at the injection site after poly ICLC injections.   "
151586|NCT01299649|"     Retrospective analysis to observe changes in short term mortality   "
151587|NCT01299636|"     The purpose of the study is to determine the maximum tolerated dose and the recommended dose     and to evaluate the safety and tolerability of PM060184.   "
151588|NCT01299623|"     We will develop and evaluate a community-based approach for disseminating comparative     effective reviews (CERs) about breast cancer prevention to African American women. The     specific aims of our research, as shown below, will target this population because of     persistent disparities in breast cancer morbidity and mortality among this population. Our     primary aims are:        1. To evaluate uptake of a community-based strategy for disseminating CERs about breast          cancer prevention to African American women based on sociodemographic characteristics,          beliefs about medical research, and medical history. We predict that participation in a          community forum will be higher among women with greater socioeconomic resources, those          who have a family history of breast cancer, and women who have more positive beliefs          about research.        2. To evaluate the impact of evidential versus non-evidential content about breast cancer          prevention on psychological and behavioral outcomes that include: knowledge of breast          cancer risk factors and prevention strategies, communication with individuals in their          social and medical network, and distrust of medical research. We predict that women who          receive evidential content that is specific for African American women will report          greater knowledge about breast cancer risk factors and prevention strategies, will be          more likely to discuss breast cancer prevention strategies with individuals in their          social and medical network, and will report greater reductions in distrust of medical          research compared to those who receive non-evidential content.   "
151589|NCT01299610|"     This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of     GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. Subjects     will be assigned to take 3 out of the 4 possible treatments for 21 ±2 days: GW870086X 0.2%     cream, GW870086X 2% cream, FP 0.05% cream (as a positive control) and placebo cream. All     subjects will be randomised to receive placebo cream. Three index lesions located on the arms     and/or legs (one on each) will be identified per subject and each treatment will be applied     to the same lesion.   "
151590|NCT01299597|"     The present study will investigate in humans the enzyme inhibition effects of SB-649868 on     CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as single     doses: alone, and on two different occasions after repeat doses of SB-649868, at the same     time as SB-649868 and 2h before SB-649868.   "
151591|NCT01299584|"     This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil     during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not     described as precautions or warnings and to identify prognostic factors that have an effect     on the AEs and to assess effectiveness of remifentanil in real clinical practices after     marketing.      The subjects are patients prescribed for remifentanil by the investigators at the sites based     on prescription information in normal clinical practices.   "
151592|NCT01299571|"     An open label, multi-centre, non-interventional post-marketing surveillance to monitor the     safety and/or efficacy of AVODART administered in Korean BPH patients according to the     prescribing information   "
151593|NCT01299558|"     This study is being done to look at the absolute bioavailability of fluticasone furoate and     GW642444 inhalation powder when administered in healthy subjects. Bioavailability is     determined by measuring the amount of the dose of inhaled medication that reaches the     circulation; the amount of inhaled fluticasone furoate and GW642444 powder will be compared     to the medication administered intravenously (where bioavailability is 100%).   "
151594|NCT01299545|"     Study Design & Objectives:      Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with     a clinical follow-up between 12 and 14 weeks.      To determine the performances of the RA-INF-Dx blood test intended to aid in the     identification of patients with rheumatoid arthritis who are unlikely to show an initial     response to infliximab and methotrexate combination therapy evaluated according to EULAR     response criteria.      Ancillary study objective:      To constitute a biocollection of samples associated with all clinical and biological data     collected at inclusion and at the evaluation visit.   "
151595|NCT01299532|"     This is an open, multi-center, non comparative study to evaluate the safety and efficacy of     Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a     maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection     (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed     for 24 months after last treatment.   "
151596|NCT01299519|"     This study will evaluate the potential beneficial cardiometabolic effect of moderate (5%)     weight loss and progressive (5%, 10%, and 15%) weight loss in obese adults without diabetes.     Participants will be randomly assigned to one of 2 groups. Group 1: supervised weight loss     group (low-calorie diet). Group 2: supervised weight maintenance group (normal diet). Of     those assigned to group 1, half of the participants will lose 5% of their body weight and the     other half will lose 5%, 10%, and 15% of their weight over time under the guidance of a     dietitian. Research testing will be repeated at each time point (5%, 10%, and 15% weight     loss). In group 2, research testing will be repeated after six months.   "
151606|NCT01299389|"     The purpose of this study is to evaluate the efficacy and safety of paliperidone palmitate as     compared with placebo in the treatment of participants with schizophrenia (psychiatric     disorder with symptoms of emotional instability, detachment from reality, often with     delusions [a false belief held in the face of strong differing evidence, especially as a     symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into     the self).   "
151607|NCT01299376|"     This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan     potassium 50 mg [L50] (+) hydrochlorothiazide 12.5 mg [H12.5] (+) amlodipine besylate 5mg     [A5]) will be evaluated and compared to the efficacy and safety of MK-0954H (L50/H12.5) in     Japanese participants. In the second part, the safety and tolerability of long-term use of     open-label MK-0954E in participants with hypertension will be evaluated. The primary     hypothesis is that MK-0954E is more effective in lowering mean trough sitting diastolic blood     pressure (SiDBP) after 8 weeks of treatment compared to MK-954H (L50/H12.5 mg) in Japanese     participants with essential hypertension who are not adequately controlled following a 8-week     treatment with filter period study drug of MK-954H.   "
151608|NCT01299363|"     This is a randomized clinical trial comparing rates of de novo dyspareunia in women with and     without vaginal dilator use following surgery for pelvic organ prolapse with traditional     posterior repair. Our hypothesis is daily use of vaginal dilators from post-op week 4 through     week 8 after posterior repair will reduce the rate of de novo dyspareunia.   "
151609|NCT01299350|"     Our objective is to compare a policy of hospital discharge guided by NT-proBNP levels versus     discharge guided by conventional clinical criteria, in patients admitted with acute heart     failure. The hypothesis is that the Nt-proBNP guided discharge will shorten hospital stay     without worsening the outcome   "
151610|NCT01299337|"     The purpose of this study is:        -  To evaluate liothyronine (Cytomel) as an accelerating agent (i.e. faster rate to          clinical remission) to electroconvulsive therapy.        -  To evaluate whether thyroid supplement acceleration can reduce the neurocognitive side          effect of ECT treatment.        -  To evaluate whether thyroid status at the time of remission is associated with          subsequent relapse rate.        -  To evaluate genetic polymorphisms in enzymes responsible for thyroid metabolism and the          serotonin transporter promoter gene in depression (5-HTTLRP).   "
151611|NCT01299324|"     The primary objective of this feasibility study is to provide clinical data to demonstrate     the safety and activity of a concentrate of nucleated cells from bone marrow aspirate (BMAC)     produced with the Harvest Bone Marrow Aspirate Concentrate System for treating patients     diagnosed with congestive heart failure (CHF).   "
151612|NCT01299311|"     The effect of Non-Exercise Activity Thermogenesis (NEAT) or inactivity on insulin sensitivity     and lipid metabolism is unclear. Research recently published shows that activities associated     with everyday activities, summarized as NEAT, such as walking and standing, have a much     greater role in energy expenditure than exercise. Therefore, the objective of the present     study is to evaluate the effect of 4 days of inactivity (mainly sitting), 4 days of everyday     activities (sitting, walking and standing), and 4 days of inactivity and exercise (sitting     and biking) on glucose metabolism and insulin sensitivity using an oral glucose tolerance     test, and on lipid metabolism in sedentary, overweight people. The investigators hypothesize     that:        1. 4 days of everyday activities (NEAT) will cause an increased glucose tolerance and          increased insulin sensitivity compared to 4 days of inactivity in sedentary, overweight          people.        2. 4 days of exercise will improve glucose tolerance and insulin sensitivity more than 4          days of NEAT with equal energy expenditure, in sedentary, overweight people.        3. Fasting triglyceride will have the same course as glucose, mentioned in 1. and 2.   "
151613|NCT01299298|"     This Phase 1 study is being conducted to evaluate 3 increasing subcutaneous (SC) doses (50,     mg, 100 mg or 200mg) of mipomersen in Japanese healthy volunteers. Eligible subjects will     receive a single study injection of either mipomersen or placebo. Subjects will be enrolled     into 1 of 3 treatment cohorts (Cohorts A, B, and C) in a dose-escalation design.     Dose-escalation will proceed only if there is an acceptable safety profile from the previous     dosing level.   "
151614|NCT01299285|"     This is a single dose study of radiolabeled [14C]-LY3009104 in healthy male volunteers to     study the absorption, distribution, metabolism, and elimination of LY3009104. This study     requires minimum of 7 days and maximum of 22 days stay. This study is for research purposes     only and is not intended to treat any medical condition.   "
151615|NCT01299272|"     The primary purpose of this study is to assess whether LY2216684 (12 mg to 18 mg once daily)     is superior to placebo as adjunctive therapy to selective serotonin reuptake inhibitor (SSRI)     in patients with major depressive disorder (MDD) who were initially partial responders to a     SSRI in the prevention of re-emergence of depression symptoms in patients with MDD who met     remission criterion during open label treatment and randomization criteria during a     stabilization period. This trial consists of two distinct periods; an open label treatment     period, which consists of two parts, 8 weeks open label with movement to 10-12 weeks open     label stabilization IF patients are in remission at end of 8 weeks (open label for 18 to 20     weeks total) followed by a randomized blinded period for 24 to 26 weeks.   "
151616|NCT01299259|"     The investigators hypothesize that text message reminders to girls diagnosed with pelvic     inflammatory disease (PID) in the emergency department (ED) will improve follow-up to their     primary care provider (PCP) after being discharged from the ED.   "
151617|NCT01299246|"     Objectives:      Preventing diabetic foot problems (DFP) and associated consequences, such as amputation, is a     critical in rural regions. The objective is to present on the association of non-invasive DFP     assessment tools and physiological indicators for the early detection of DFP among rural     cases of diabetes in Taiwan.   "
151658|NCT01298713|"     Tamoxifen is a classical treatment for breast metastatic cancer after 3rd generation     anti-aromatase hormonotherapy in adjuvant or in metastatic line. The Tamoxifen efficacy is     lowered by the hormonoresistance mechanisms due to the primary use of the anti-aromatases.     The Pi3K-AKT-mTor pathway is frequently associated to the hormonoresistance mechanisms. This     study is aimed to check if the inhibition of this signal transduction pathway by a synthetic     mTor inhibitor (Everolimus) could improve the efficacy of the Tamoxifen.   "
151659|NCT01298700|"     This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution     compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular     hypertension.   "
151620|NCT01299207|"     Stents are devices utilized to treat cholesterol blockages of the coronary (heart) arteries.     The introduction of drug-eluting (coated) stents into clinical practice is regarded as a     revolutionary breaktrhough, as it has reduced the incidence of re-narrowing of the arteries     after percutaneous coronary interventions are performed. There has been, however, concerns of     increased risk for clot formation in the heart arteries of patients treated with drug-eluting     stents. Therefore, in order to lower the risk of clot formation, it is recommended that     patients receiving these types of stents, be treated with dual antiplatelet therapy (blood     thinning medication) for one year. The effect of this strategy, however, on clot formation     and bleeding complications when utilizing newer generation stents, such as the Xience:     Everolimus-eluting Stent, have not been well described.      Therefore, the aim of this registry study is to evaluate the risk of adverse cardiovascular     events, including mortality, non-fatal myocardial infarction, stent thrombosis, hemorrhagic     stroke, and severe bleeding in relation to the timing and discontinuation of dual     antiplatelet therapy in patients treated with Xience drug-eluting stents, and compare it to     patients that do not discontinue dual antiplatelet therapy.   "
151621|NCT01299194|"     Statins are a class of drug used to prevent heart attacks and strokes by lowering blood     cholesterol levels. They have also been found to have a beneficial side effect of lowering     the level of inflammation in the body. This is thought to be one of the reasons they are     effective in treating heart attacks and strokes. Laboratory experiments have shown that     statins reduce lung inflammation in response to bacteria and this is a promising development     for the treatment of chest infections.      Bronchiectasis is a chronic disabling lung disease characterised by chronic sputum production     and recurrent chest infections. 2/3 of patients are chronically colonised with bacteria     (normally the lungs are sterile) and this leads inflammation in the lung and in the rest of     the body.      There are no effective treatments for bronchiectasis other than antibiotics for chest     infections. With increasing antibiotic use, there is increasing antibiotic resistance and new     treatments for this disease are needed.      The investigators intend to study Atorvastatin in patients with bronchiectasis with     colonization with pseudomonas aeruginosa. The investigators will give Atorvastatin to 16     patients with this disease while 16 patients will receive placebo. This will be a crossover     study where patients will receive atorvastatin or placebo for 3 months, followed by a statin     wash out period of 6 weeks. Thereafter the groups will cross over and the group receiving     atorvastatin will now receive placebo and those receiving placebo will receive atorvastatin     for 3 months. The investigators will measure inflammation in their lungs and in the rest of     their body before and after treatment with atorvastatin. The investigators will also assess     their quality of life and number of chest infections over a 7.5 month period.      This pilot study will determine if there is any role for statins are an anti-inflammatory     agent in patients with bronchiectasis.   "
151622|NCT01299181|"     The investigators hypothesise that long term statin treatment will improve patients' symptoms     through its anti-inflammatory effect. The beneficial effects on patient symptoms (cough,     sputum volume, bacterial load, airway function, exercise tolerance, exacerbation frequency     and health related quality of life) will be consequent on reduced neutrophilic airways     inflammation.   "
151623|NCT01299168|"     The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the     Banff Classification which represents arbitrary international consensus. Recent data-driven     approaches using molecular and conventional technologies indicate that mere consensus     produces frequently incorrect diagnoses with potential harm to patients due to inappropriate     treatment. To address this unmet need and improve diagnostics in the area of organ     transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new     diagnostic system that combines the molecular and histopathological features of transplant     biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic     System. The present study will validate and refine this system in 500 prospectively     unselected biopsies for clinical indications from American, Canadian and European centres in     addition to 300 biopsies already collected. Due to a considerable interest and support from     participating Centers, the study is further extended to 1200 prospective biopsies. Thus this     is the extension of the INTERCOM study (INTERCOMEX). In addition to demonstrating the     feasibility and value of this System in routine patient care and clinical trials, the study     will develop and optimize a transparent and user-friendly reporting format to communicate     this information to clinicians and obtain detailed feedback on how this system can best     improve patient care.   "
151624|NCT01299155|"     To prospectively evaluate postoperative visual and refractive parameters in a series of     subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with     LENTIS MPlus Intraocular Lens (IOL).   "
151625|NCT01299142|"     The purpose of this study is to determine the safety and tolerability of the anti-TSG101     human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy volunteers.   "
151626|NCT01299129|"     Purpose:      To evaluate the effect of intravitreal triamcinolone acetonide (IVTA) on uveitis-associated     cystoid macular edema (CME) using high resolution optical coherence tomography (SDOCT) in     conjunction with thorough visual function testing.      Methods:      28 patients with uveitis-associated CME were examined before intravitreal triamcinolone     injection (IVTA) (v1) and at day 1 (v2), week 1 (v3) and month 1 (v4) after injection.     Retinal anatomy was evaluated using Cirrus HD-OCT (Carl Zeiss Meditec). Visual function     testing consisted of assessing ETDRS distance visual acuity (VA), reading acuity and reading     speed using a standardized German-language test (Radner Reading charts), contrast sensitivity     using Pelli-Robson Contrast Sensitivity charts and fundus-controlled microperimetry using the     MP-1 Microperimeter (Nidek). Here we utilized a cartesian grid consisting of a central locus     and three concentric box-shaped stimulation areas. The changes of retinal anatomy over time     were compared to the respective outcome of visual function.   "
151627|NCT01299116|"     In the proposed study, women aged 18-29 seeking oral or injectable contraception will be     offered an opportunity to try LARC instead; the FDA-approved options include two types of     intrauterine products and one type of subdermal contraceptive implant. Over a 24 month     period, the experiences of LARC users will be compared to the experiences of those opting for     their initial short-acting method.   "
151628|NCT01299103|"     The study will enroll and treat a patients to assess improvement in the appearance of facial     wrinkles.   "
151629|NCT01299090|"     Use of RF device to treat wrinkles of the neck   "
151630|NCT01299077|"     The purpose of this study is to observe the overall satisfaction of patients with     degenerative disc disease after receiving triple therapy.   "
151652|NCT01298791|"     Patient satisfaction is affected by physician communication styles and communication at the     bedside. The investigators are conducting a randomized controlled trial involving both     providers and families to determine if providers sitting down while talking with families,     will improve one aspect of quality care delivered during an inpatient stay as measured by     patient/family satisfaction. The investigators will additionally study the affects of the     intervention on the following outcomes: family assessment of provider communication,     readmission rates, and length of stay.   "
151631|NCT01299064|"     Preliminary evidence attests to the effectiveness of mindfulness-based interventions in     reducing symptoms associated with a variety of medical and psychological conditions. However,     research progress has been hampered by discrepancies in how mindfulness has been     operationalized, assessed, and practiced. Existing contemporary assessments of mindfulness     were developed exclusively by Western scientists and have exhibited questionable validity,     particularly among diverse cultural groups. Operational definitions of mindfulness are     essential for the development of valid measures, which in turn are necessary for     investigating the mechanisms of change in mindfulness-based interventions. Therefore, the     overall goal of this study is to create a mindfulness measure that is informed by the     experience of mindfulness experts - Theravāda, Tibetan, and Zen Buddhist clergy and lay     practitioners. To do so, this study will employ the preliminary phases of the sequential     exploratory mixed methods for instrument design model. The first phase will involve     conducting open-ended interviews with Theravāda, Tibetan, and Zen Buddhist clergy and lay     practitioners to ascertain expert information on mindfulness and closely related Buddhist     concepts. This qualitative process allows the experts to define the phenomena of interest     (i.e., addresses issues of validity). In the second phase, the investigators will use the     themes and specific phrases evoked during the qualitative interviews to develop items for a     draft closed-ended self-report measure of mindfulness. Following completion of the research     outlined in this proposal, the investigators will submit a subsequent proposal to thoroughly     evaluate the psychometric properties of our draft mindfulness questionnaire in a variety of     different cultures and contexts. This measure can be beneficial in clinical research by     helping to elucidate the mechanisms of change in mindfulness-based psychotherapies in the     United States and equally so in other cultures such as Thailand, where mindfulness and other     Buddhist practices have already been integrated into mainstream mental health treatment.     Therefore, our aim is to create a measure that can help improve the assessment and clinical     use of mindfulness.   "
151632|NCT01299051|"     The proposal of this study is to compare the effectiveness of two worksite weight management     programs at Duke: Steps to Health (STH) ('usual standard of care') and the more extensive     Steps to Health Plus! (STH+). We have added an additional follow-up, by invitation only, for     participants in the study who agreed to be contacted for future research.   "
151633|NCT01299038|"     Research studies have shown a strong association between cancer and blood clots in the veins     (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary     embolism) which in severe cases may be life threatening. Studies have demonstrated that     increases in microparticles may contribute to the development of deep vein thrombosis in     cancer patients. The purpose of this research study is to see if rosuvastatin lowers the     number of tissue factor bearing microparticles in the blood (TFMP). TFMP are small particles     that are generated from different types of blood cells in the body. In people who have     cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor     for deep vein thrombosis.   "
151634|NCT01299025|"     The aim is to evaluate balance training using Nintendo Wii Fit. The hypothesis is that a     period of training will increase balance capacity och self-efficacy.      People with diagnosed multiple sclerosis are invited to participate. Estimation of study     power gave that 29 people in each group was necessary to detect a difference in the primary     outcome measure, Timed Up and Go test.      Other measures used are the Four square step test, Dynamic Gait Index, Timed stands test, 25     foot walking test, 12-item Walking scale and the ABC scale.      Participants were randomised to either training or control. The training consisted of 6 weeks     training with Nintendo Wii Fit 30 minutes 2 times a week.   "
151635|NCT01299012|"     Evaluating the use of Liraglutide in patients with Type 1 Diabetes.   "
151636|NCT01298999|"     The purpose of this study is to determine whether treatment with an experimental drug called     YF476 in patients with Barrett's esophagus reduces the expression of tissue markers that are     associated with an increased risk of developing esophageal cancer.   "
151637|NCT01298986|"     Rationale: To determine the most beneficial ablation methodology for individual patients with     paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as     surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place     the epicardial and endocardial ablation lines.      Objectives: Catheter and surgical ablation are being offered today to patients with drug     refractory and symptomatic atrial fibrillation. This study is designed to assess the most     efficient ablation approach in patients with paroxysmal and persistent atrial fibrillation.     In patients with left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein     isolation performed surgically will be combined with right and left atrial flutter lines     performed using a transcatheter approach) will be compared to percutaneous catheter ablation     to isolate the pulmonary veins and apply the left and right atrial flutter lines with removal     of LA appendage. In the group of patients with left atrial size 5.0-6.0 cm the Hybrid     approach is going to be compared to the minimally invasive Cox-Maze III procedure.      Our hypotheses with regard to the rate of return to sinus rhythm off antiarrhythmic drugs at     6 months will demonstrate that the Hybrid approach is going to be a: superior to percutaneous     catheter ablation in the less than 5 cm left atrial group and b: non-inferior when compared     to the Cox-Maze III procedure in the 5-6 cm left atrial cm group.      We hypothesize that the safety of all procedures will show no differences and that there will     be no differences in clinical complications between groups.   "
151638|NCT01298973|"     The purpose of this study is to look at the ability of Viscoat to ensure proper wound     closure.   "
151639|NCT01298960|"     Experimental study to evaluate if rGH addition to a standard controlled ovarian stimulation     treatment improves ovarian response in women with previous poor ovarian response.   "
151640|NCT01298947|"     The objective of this study is to evaluate the safety and efficacy of preparing a vessel with     photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local     Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation   "
151641|NCT01298934|"     LBH589 is an oral drug that targets the myelofibrosis cells in the bone marrow and induces     cell death by allowing for the expression of certain suppressed genes that are important in     regulating cell survival. Based on laboratory studies, the hypothesis is that this drug will     selectively kill the stem cells responsible for causing myelofibrosis and result in reduction     in spleen size and ultimately restoration of normal bone marrow function.   "
151653|NCT01298778|"     In previous studies the investigators have seen that the severity of pain one day after     cesarean delivery can predict the presence of pain and depression 2 months later. The     investigators believe those at risk for severe acute post-partum pain can be identified, and     medical interventions can be tailored to manage postoperative pain more effectively.   "
151654|NCT01298765|"     The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment     of chronic pain.   "
151655|NCT01298752|"     The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic     Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following     cataract surgery.   "
151656|NCT01298739|"     Asthma control study 2011   "
151642|NCT01298921|"     Cluster headache is a disorder marked by frequent attacks of short-lasting, severe,     unilateral head pain with associated autonomic symptoms. It is the most severe head pain     syndrome known. Currently, the two most common treatments for cluster headaches are inhaled     oxygen and injectable sumatriptan. These treatments do not work for all cluster headache     patients, and patients who smoke may eventually develop contraindication to triptans. New     treatment options are needed.      An alternative method of oxygen delivery (as opposed to continuous flow) uses a demand valve     that is controlled by respiration rate, allowing increased oxygen flow in response to     increased demand. This system may be more efficacious at stopping a cluster headache attack     than the currently prescribed oxygen delivery system.      This study will compare the effectiveness of oxygen delivered via demand valve versus     continuous high flow oxygen via non-rebreather face mask in the acute treatment of a cluster     headache attack. All patients will treat one cluster headache with each of the 2 treatment     methods.   "
151643|NCT01298908|"     Randomized controlled trial, a method used to implement the random allocation sequence is     numbered containers.      The aim of the study is to compare operative treatment, ultrasound guided laser ablation and     ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great     saphenous trunks. On the grounds of the available data, the study hypothesis is that using     laser or operative treatment more than 20 percent better outcome can be achieved compared to     foam sclerotherapy.   "
151644|NCT01298895|"     The purpose of the study was to evaluate optical ocular components in patients with     pseudoexfoliation syndrome using optical low coherence reflectometry. A prospective cohort     study of 224 eyes of patients planned for cataract surgery was conducted from January 2009     until July 2009. Patients were divided in two groups: the first group of 47 eyes with     cataract complicated with pseudoexfoliation syndrome and the control group of 177 eyes with     uncomplicated cataract. Each group was further divided into two subgroups based on its     refractive state: emmetropes and hypermetropes. The optical low coherence reflectometry     biometer LENSTAR® LS 900® was used to define ocular optical components.   "
151645|NCT01298882|"     Aim. To assess the effect of interleukin 1β (IL-1β) and tumor necrosis factor α (TNFα)     inhibition with diacerein administration on insulin secretion and metabolic control of     drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.      Hypothesis. Diacerein administration improves insulin secretion and metabolic control of     drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.      Materials and methods. Design: Randomized, double-blind, placebo-controlled clinical trial.     Population: 40 drug-naïve adult patients with T2DM and overweight or obesity. Measurements: A     metabolic profile including IL-1β, TNFα, interleukin 6, and fasting insulin levels, as well     as, hyperglycemic-hyperinsulinemic clamp technique; to assess the phases of insulin secretion     and insulin sensitivity. Intervention for 2 mo: diacerein (50 mg once daily) for the first 15     days and twice daily for 45 additional days or placebo. Statistical analyses: Wilcoxon signed     rank and Mann-Whitney U test.   "
151646|NCT01298869|"     Clinical trials have demonstrated the efficacy of HPV-6/11/16/18 vaccination (Gardasil.     Merck) 3 doses at day 1, month 2, and month 6 to lower the occurrence of high-grade cervical     intraepithelial neoplasia than did those in the placebo group. The immunogenicity and     efficacy of the HPV vaccine has not been proven in late stage chronic kidney disease (CKD)     population. The cellular and humoral immune responsiveness of CKD population are impaired by     the retention of uremic toxin due to glomerular filtration rate (GFR) reduction, the     vaccination efficacy can be altered and the effective dose/schedule of the vaccine may need     to be adjusted, mostly increase in CKD patients.      This study aims to investigate the immunogenicity of quadrivalent HPV-6/11/16/18 vaccination     (Gardasil. Merck) by current recommended dose/schedule in CKD stage IV-V patients and compare     to non-CKD patients. Although a minimal peak anti-HPV response associated with protective     efficacy has not been determined, the equivalent immune response in CKD and non-CKD patients     if can be demonstrated by this study should be extrapolated to the CKD population. If less     immune response results, the more intense dose/schedule of the vaccine should be further     studied.   "
151647|NCT01298856|"     There will be a difference in ankle functional ability between athletes with chronic ankle     instability in the intervention group and in the control group.   "
151648|NCT01298843|"     The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.   "
151649|NCT01298830|"     The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with     space-occupying intracerebral hemorrhage.   "
151650|NCT01298817|"     The main objectives of this study are to collect pilot data to assess feasibility (accrual,     retention, compliance), to estimate the variability of outcome measures, and to obtain     preliminary estimates of treatment efficacy based on group differences in body composition     (decreases in ectopic fat stores while maintaining lean mass), cardio-metabolic risk factors     including glucoregulatory function (glucose, insulin), inflammation (C-reactive protein,     IL-6), blood pressure and lipids (HDL, LDL, TC, TG), and measures of physical function and     muscle strength. While this is just a pilot study, randomization will be used so that the     investigators can obtain a realistic estimate of accrual (which is often less in a randomized     trial) and an unbiased estimate of treatment efficacy.      The investigators will accomplish these objectives by conducting a 2-arm, 3-month randomized,     clinical trial in 24 older (60-79), abdominally obese (BMI ≥30 kg/m2 and waist circumference     ≥ 102 cm and ≥ 88 cm in men and women, respectively) men and women. Participants will be     randomized to a soy-based or animal-based, 3-month, hypocaloric dietary intervention to     achieve our specific aims:      Primary Aim: To determine our ability to recruit and retain older, obese adults to a 3 month     soy-based meal replacement weight loss intervention and assess the study participant's     ability to adhere to the intervention protocol (weight, compliance logs, serum isoflavones).      Secondary Aims:        1. To estimate the variability of and obtain preliminary estimates of the effect of the          soy-based meal replacement on measures of body composition, including abdominal (total,          subcutaneous and visceral fat), liver, and pericardial fat; anthropometrics (body          weight, waist/hip circumference); and whole body fat and lean mass.        2. To estimate the variability of and obtain preliminary estimates of the effect of the          soy-based meal replacement on biomarkers of cardiometabolic risk including          glucoregulatory function (glucose, insulin), inflammation (C-reactive protein, IL-6),          blood pressure and lipids (HDL, LDL, TC, TG).        3. To estimate the variability of and obtain preliminary estimates of the effect of the          soy-based meal replacement on physical function (short physical performance battery,          400-m walk) and muscle strength (grip and knee extensor strength) and size (CT thigh          muscle).        4. To document any adverse events associated with the soy-based meal replacement.   "
151651|NCT01298804|"     Maternal depression disproportionately affects low-income and minority women, and has     profound negative impacts on their children. The investigators are conducting a randomized     trial of a systems approach to identify mothers at risk for depression in Head Start - a     federally funded early learning program for children of low-income families - and to provide     an on-site intervention to prevent or alleviate depressive symptoms; improve functioning;     and, where appropriate, proactively link mothers to more definitive mental health services.   "
157265|NCT01225224|"     A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of     ASP015K in healthy nonelderly men.   "
151662|NCT01298661|"     Chronic Obstructive Pulmonary Disease (COPD) leads to a reduction in exercise capacity that     affects the quality of life and increases mortality of these patients. So, exercise tests are     considered as an essential component of the clinical evaluation of the patients with COPD.     The objective of this study is to evaluate the reproducibility sensitivity and validity of     the Six Minute Step Test (6MST) in patients with COPD and in health volunteers, and verify     its relation with the Body-Mass Index, Airways Obstruction, Dyspnea and Exercise Capacity     Index (BODE). This Observational, Transversal, Prospective study will be conducted in the     Special Unit of Respiratory Physiotherapy, of the Federal University of São Carlos. To     participate in this study, 120 subjects, both gender, will be invited and will be allocated     in five groups: Group I (30 healthy young subjects of 17 to 27 years old), Group II (30     healthy elderly individuals of 60 to 75 years old), and patients COPD, 60 to 80 years old,     with mild, moderate, severe and very severe obstruction determined by the forced expiratory     volume in one second (FEV1) by forced vital capacity (FVC) relation FEV1/FVC <70% and FEV1     in predict percentage < 80% composing the Group III (20 COPD patients in GOLD stage I), Group     IV (20 COPD patients in GOLD stage II) and Group V (20 patients COPD stages III and IV). All     subjects will be submitted to body composition and anthropometric assessment, pulmonary     function test, three 6-minutes walk test (6MWT) and three 6MST. Furthermore, the patients of     the groups III, IV and V will answer the Modified Medical Research Council (mMRC) scale, and     BODE index will be calculated to each of them.   "
151663|NCT01298648|"     This study will be conducted to assess adverse drug reactions, incidence of adverse events,     and factors that may affect the safety and effectiveness of Humira for the treatment of     Crohn's disease.   "
151664|NCT01298635|"     Primary angle closure glaucoma (PACG) is caused by contact between the iris and trabecular     meshwork, which in turn obstructs outflow of the aqueous humor from the eye. This contact     between iris and trabecular meshwork (TM) may gradually damage the function of the meshwork     until it fails to keep pace with aqueous production, and the pressure rises, and at last the     optic nerve is damaged, the vision may be lost in some severe cases. Therefore, ocular     pressure reduction is the key to treat the disease and prevent blindness. Trabeculectomy is     the most common conventional surgery performed for glaucoma. This allows fluid to flow out of     the eye through this opening, resulting in lowered intraocular pressure(IOP) and the     formation of a bleb or fluid bubble on the surface of the eye.      Cataract surgery is common in the elderly. Cataract surgery is the removal of the natural     lens of the eye (also called crystalline lens) that has developed an opacification, which     is referred to as a cataract. Cataract extraction includes intracapsular cataract extraction,     extra capsular cataract extraction & phacoemulsification, and phacoemulsification is the     preferred method. It has been reported that IOP reduction could occur in cataract patients     with PACG after the cataract surgery. For some cases with PACG, such IOP reduction may be     insufficient for neuronal protection, and many patients still require glaucoma medication and     incisional surgery such as trabeculectomy to control IOP. In such cases, a combined     cataract-glaucoma procedure (phacotrabeculectomy) is a reasonable option. In keeping with     this concept, previous studies have shown that phacotrabeculectomy could effectively and     simultaneously reduce IOP and improve vision in patients with a coexistence of PACG and     vision-threatening cataract. However, phacotrabeculectomy may heighten inflammatory response,     result in a higher frequency of postoperative complications such as hyphema and fibrin in the     anterior chamber, endophthalmitis, and increased scarring of the filtering bleb. Thus, it is     unclear whether phacotrabeculectomy is as effective and safe as trabeculectomy in lowering     IOP for PACG patients.      In the present study, the investigators compared the efficacy and safety of     phacotrabeculectomy and trabeculectomy in patients with coexisting PACG and cataract.   "
151665|NCT01298622|"     To investigate the structural/functional abnormalities and the possible genetic     endophenotypes of Obsessive-compulsive disorder (OCD) patients and their core families.   "
151666|NCT01298609|"     The study is designed as a prospective, randomized, double-blind, single center study with a     6 month duration post permanent system implantation. Forty patients will be implanted.      During trial stimulation, patients will be randomized into one of two study arms for two     weeks. Crossover will occur at the 2 week study visit to the opposite group. After completion     of these two arms, every patient will subsequently complete participation in the third study     arm.      After completion of the third arm, patients will be evaluated to determine if they are a     positive responder responder. If so, the patient will have the option of obtaining the     permanent implant.   "
151667|NCT01298596|"     The purpose of this study is to compare the rate of recurrence of cervical intraepithelial     neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of     follow-up and to compare the shedding of HIV-1 from the cervix between HIV-positive women     receiving cryotherapy versus LEEP over 3 weeks of follow-up.   "
151668|NCT01298583|"     The purpose of this study is to compare the improvement in ankle control and brain activation     in subjects with stroke resulting from two different forms of telerehabilitation: tracking     training, emphasizing accurate movements, versus movement training, involving simple     movements.      Hypotheses:        1. The Track group will show greater improvement in ankle range of motion compared to the          Move group.        2. The Track group will show greater improvement in ankle tracking accuracy and greater          changes in fMRI (increase in relative volume of activation for ipsilesional sensorimotor          cortex, increase in laterality index, and decrease in blood-oxygen-level-dependent          (BOLD) signal intensity index) compared to Move group.        3. The Track group will show greater improvement in tracking accuracy at an untrained joint          (knee) compared to the Move group.        4. The Track group will show greater improvement in standing balance.        5. The Track group will show greater improvement in walking speed and ankle dorsiflexion          during gait compared to the Move group.   "
151669|NCT01298570|"     This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed     to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI     (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.   "
151670|NCT01298557|"     The overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic     brain injury (TBI) are due to selective disruption of the long association white matter     tracts of the cerebral hemispheres, with resulting functional impairment of the network of     cortical regions that are interconnected by these long-range association pathways. We propose     that traumatic white matter injury can be measured with diffusion tensor imaging (DTI) and     that the impaired cortical activation can be detected with magnetoencephalography (MEG), and     that the results of these imaging examinations will correlate with neurocognitive status and     functional recovery after TBI.   "
151671|NCT01298544|"     In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received     either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular     Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3     years after the last vaccination) will assess the antibody concentrations in children who     previously completed Wyeth study 0887X-101518.   "
151673|NCT01298518|"     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The     primary purpose of this trial is to evaluate the safety and tolerability, and     pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.   "
151674|NCT01298505|"     The purpose of this study in healthy people is to investigate the safety, toleration and time     course of PF-03654764 in the blood, following multiple doses given by mouth together with     fexofenadine.   "
151675|NCT01298492|"     This study provides open-label drug to eligible patients who have completed a prior study of     PF-00547659. The primary endpoint for this study is long-term safety.   "
151676|NCT01298479|"     The purpose of this study is to determine the volumetric delivery of the Uniject.   "
151677|NCT01298466|"     A0081256 is a prospective, open-label, multi-centre European study designed to raise     awareness and enhance the diagnosis of patients with chronic low back pain with a neuropathic     pain component in primary care who are refractory to standard analgesic therapy and/or one     treatment for neuropathic pain and evaluate the effectiveness and tolerability of pregabalin     in this population. The impact of pregabalin on analgesia, patient satisfaction with     treatment, patient anxiety and depression, sleep interference, physical functioning and work     productivity will be assessed.   "
151678|NCT01298440|"     Retinal blood flow velocity is affected by Bevacizump intravitreal injection. This effect is     correlated to treatment success.   "
151679|NCT01298414|"     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may     help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research study is looking at biomarkers in bone marrow samples from young     patients with acute myeloid leukemia.   "
151680|NCT01298401|"     RATIONALE: Monoclonal antibodies, such as ganitumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Specialized     radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a     high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage     to normal tissue.      PURPOSE: This phase I trial is studying the side effects and best dose of ganitumab when     given together with gemcitabine hydrochloride followed by radiation therapy, ganitumab,     capecitabine, and maintenance therapy in treating patients with locally advanced cancer of     the pancreas.   "
151681|NCT01298388|"     RATIONALE: Studying medical records and collecting questionnaires from patients who were     enrolled as children in clinical trials for acute lymphoblastic leukemia may help doctors     learn about long-term effects of treatment and plan the best treatment.      PURPOSE: This clinical trial is studying the long-term outcomes of patients with acute     lymphoblastic leukemia who were enrolled as children on clinical trials EORTC-58741,     EORTC-58831, EORTC-58832, or EORTC-58881 between 1971 and 1998.   "
151682|NCT01298375|"     Type 2 diabetes (T2D) is a global burden disease affecting almost 200 million people and is     expected to nearly double by 2030 (1). It is imperative that this disease is kept under     control, and that we begin to reverse the direction of its incidence. We propose to start by     identifying the physiological and molecular aspects of the problem in all spectrums of the     disease (ie from insulin sensitive athletes to sedentary lean and obese individuals and     further to overt type 2 diabetics), and focus our efforts on examining the differences and     identifying the stages of progression for possible targets of future intervention. The     proposed study Metabolic Phenotyping is novel in its target populations and innovative in     its use of state-of-the-art techniques. We hypothesize that the in vivo differences in     metabolic flexibility and mitochondrial function between endurance athletes and type 2     diabetics and their lean and obese controls are retained in vitro and will offer a new model     in which to study the underlying mechanisms of the progression of T2D.   "
151683|NCT01298362|"     The purpose of this study is to identify the combined impact on bone loss as well as the     incidence of bone fractures in women with estrogen receptor (ER)-positive, early breast     cancer treated with an aromatase inhibitor (AI) either as first line therapy or as     maintenance therapy after initial treatment with chemotherapy, in real life clinical settings     in Greece.   "
151725|NCT01297816|"     This process appears as a incredible and progressive event that will not stop till     reattachment of RPE and neurosensory retina happened .      Process of degeneration begins from first hours of RD (Retinal Detachment) establishment     Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered     in recent years .      How to stop this phenomena and neuroprotective agent role in this issue are a new interest of     researcher.      In the study the investigators are planning to perform a clinical trial to demonstrate the     minocycline neuroprotective effect in a double blind design as this impact has been     implicated previously in a animal study   "
151798|NCT01296841|"     The investigators hypothesize that outpatient clinical care of Inflammatory Bowel Disease     patients may be provided using a new computerized system over standard network - called     Collaborative Imaging - with similar patient experience compared to a conventional clinic     visit.   "
151684|NCT01298349|"     The present study aimed to examine face and object perception processes in schizophrenic     patients. Schizophrenia is associated with deficits in visual processing that represent a key     feature in the disorder. Previous studies have shown that schizophrenics exhibit deficits in     a variety of facial-processing tasks (e.g., face recognition, recognition of facial     expressions), that may severely hinder the patients' interpersonal and social skills. Some     investigators have attributed these deficits to impairments in configural processing in     schizophrenia. That is, an impairment in the ability to process the spatial relations between     the constituent parts of a configuration (e.g., the spacing between the eyes of a given     face). To date, studies aimed to investigate this possibility (e.g., Schwartz et al., 2002;     Yong-Wook et al., 2008) yielded conflicting results. Additionally, it is not yet clear     whether the hypothesized impairment in configural processing is restricted to faces, or     whether it is more general in nature and applies to objects as well.   "
151685|NCT01298336|"     The purpose of this study is to determine the 6-months sputum conversion rate with a     clarithromycin or moxifloxacin containing regimen in patients with a M. xenopi pulmonary     infection.   "
151686|NCT01298323|"     The purpose of this study is to evaluate the effect of patient outreach program on the     proportion of time patients with MTC experience moderate or severe AEs during first 12 months     of treatment with vandetanib   "
151687|NCT01298310|"     To characterize the phenotype in patients with Morton's neuroma and to explore the effect of     local administration of Xylocaine (lidocaine)   "
151688|NCT01298297|"     The purpose of this study is to determine whether sublingual buprenorphine is effective in     the treatment of acute pain in adult patients with extremity bone fractures   "
151689|NCT01298284|"     New strategy to improve the outcomes in patients with HCC and acute variceal bleeding. NSBB     added to endoscopic ligation may further reduce rebleeding in cirrhotic patients.   "
151690|NCT01298271|"     Design a randomized trial to compare the effect of endoscopic cyanoacrylate injection     obliteration versus non-selective beta-blocker in the primary prevention of gastric variceal     bleeding.   "
151691|NCT01298258|"     The investigators hypothesize that the different components of arterial load are coupled with     different components of LV function. The regional ventriculo-arterial couplings may be     important in the pathogenesis of heart failure and ventricular remodeling, and in the     prediction of future cardiovascular events.   "
151692|NCT01298245|"     The primary purpose of the study is to investigate allele frequencies of candidate genes in     Chinese diabetic patients with or without known diabetic retinopathy. Two hundred Chinese     diabetic patients, aged between 20 - 75 years old, who have received ophthalmic fundus     examination (either by an ophthalmoscope or fundus camera) within 6 months before the study     will be recruited for the study. Each subject will receive anthropometric and blood pressure     measurements. Then, fasting blood samples will be taken for the measurements of glucose,     HbA1c, lipid profile, and biochemistry. An additional 10 ml blood sample will be taken for     DNA extraction from buffy coat. Meanwhile, the participant will receive structural     questionnaires for demography, personal history, medical history and concomitant medication.     Single nucleotide polymorphisms (SNPs) in candidate genes and in targeted chromosome regions     will be genotyped by using the ABI TaqMan assays. The differences in the distribution of     genotypes and alleles between the study groups will be analyzed using appropriate statistical     methods. Through the study, the investigators hope to build up a platform for future     large-scale genetic studies of diabetic retinopathy. The investigators also hope to set up     priority of candidate loci for future studies.   "
151693|NCT01298232|"     Left ventricular systolic time intervals, including pre-ejection period (PEP), ejection time     (ET), and their ratio (PEP/ET), is determined by the systolic and diastolic function and     ventriculo-arterial coupling. The investigators have shown the usefulness of the     electromechanical activation time (EMAT, equals PEP minus isovolumic contraction time) in the     prediction of cardiac mortality or re-hospitalization for heart failure in patients with the     acute heart failure syndrome (AHFS). Therefore, the objective of the present proposal is to     compare 12-month outcomes of EMAT-guided vs symptom-guided heart failure therapy in patients     with AHFS.   "
151694|NCT01298219|"     The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone     administration in subjects with      OBD.   "
151695|NCT01298206|"     The pandemic A/H1N1 virus was named swine flu when the current outbreak started. Although     it is not yet confirmed that the index case acquired the virus from pigs, the nomenclature     swine flu was due to the fact that the virus is triple-reassortant with genes from swine,     avian, and human influenza origins. A total of 57,809 cases were reported in the WHO EMRO     region, 693 of whom have died (1.2% case fatality). Lebanon had 1,838 confirmed cases with 5     deaths, it is estimated that 4% of these cases required hospitalization. Most cases of     pandemic influenza presented with fever, cough, and sore throat. Other common symptoms     included myalgia, headache, and rhinorrhea. The pandemic A/H1N1 virus appears to be very     successful at human-to-human transmission. It is also causing infections beyond the     traditional seasonal variation of previous human influenza viruses. Unlike seasonal influenza     viruses that usually cause severe infections requiring hospitalization among the elderly and     children under 5 years old, the pandemic A/H1N1 viruses are causing more severe illness among     young adults. Several reports have associated certain underlying conditions with severe     illness. Such conditions were pregnancy, asthma, diabetes, obesity, and heart disease.   "
151726|NCT01297803|"     Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results     and better control of intraocular pressure complications such as corneal endothelial cell     loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap     dissection. Mitomycin_c application after sclera flap dissection probably increases corneal     endothelial cell loss. This study compares Mitomycin_c application two methods: before and     after sclera flap dissection with regard to success rate and complication. patients on base     of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups(     before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism,     polymegathism and intraocular pressure before and one month, three months, six months after     surgery will measured.   "
151934|NCT01295047|"     The investigators are looking at the different impacts of atenolol, verapamil and perindopril     on large artery and lv function in marfan syndrome. It is a double-blind, randomised     cross-over trial.   "
151696|NCT01298193|"     This is a prospective, multicenter, open label, non-comparative trial in Spain.      The primary objective of this study is to determine the complete response, defined as no     vomiting and no use of rescue treatment, in women with early-stage breast cancer treated with     one cycle of Docetaxel-Cyclophosphamide and active therapy for the prevention of     CINV(Chemotherapy-induced nausea and vomiting) day 1, 5-HT3 antagonist plus 3 days of     dexamethasone. A second step (efficacy phase) is designed to examine the efficacy and     tolerability of aprepitant in the second cycle among patients who failed to the previous CINV     prevention treatment.      The study will focus on early-stage chemonaïve breast cancer patients receiving     docetaxel-cyclophosphamide and a 5-HT3 antagonist plus dexamethasone for the CINV prevention.     The CINV incidence in those patients will be evaluated on the first cycle. All refractory     patients, will be asked to participate in the second phase, where aprepitant on days 1, 2 and     3 will be added to their antiemetic regimen.      Assuming a drop out of 5%, 212 patients will be included in the study. It is anticipated that     around 48 patients will enter the efficacy phase.      The duration of the study, from first patient visit to last patient visit will be     approximately 21 months.   "
151697|NCT01298180|"     The purpose of this study is to estimate the sensibility at the growth hormone in vivo at the     children presenting a Prader-Willi syndrome (SPW) in comparison with children presenting a     deficit in growth hormone (GHD).   "
151698|NCT01298167|"     The purpose of the study is to look at which nonpermanent superficial closure method,     cyanoacrylate tissue glue or fast absorbing gut suture, leads to a better cosmetic and     functional outcome in repairs of facial wounds after Mohs surgery.   "
151699|NCT01298154|"     The purpose of this protocol is to study the effects of intact and hydrolyzed yellow pea     protein, compared to intact and hydrolyzed whey protein, on satiety, food intake, and glucose     metabolism in healthy young men. The specific objective is to investigate the effects of 20 g     available protein for 4 different protein types (intact and hydrolyzed pea and whey proteins)     and water (control) on satiety, food intake and blood glucose before and after a meal. The     specified amount of protein was chosen based on our previous studies on intact pea protein     suggesting that 20 g may reduce food intake and pre-meal blood glucose 30 minutes before a     test meal. Whey protein has been chosen as a reference protein because it has been     extensively studied and its effects on blood glucose and food intake are being elucidated     within our laboratory.   "
151700|NCT01298141|"     The purpose of this study is to observe the safety of agalsidase alfa in Canadian patients     with Fabry disease.   "
151701|NCT01298128|"     The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and     medications are delivered locally. It has been proven to be as safe and effective as the     combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to     minimal systemic absorption. Following a single vaginal insertion, steroid concentrations     remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to     better compliance, tolerability and acceptance by patients requiring ovarian suppression     prior to COH for IVF.   "
151702|NCT01298115|"     This prospective observational study is designed to find out what treatment options new     patients with chronic kidney disease learn about from their renal unit.      Aims: To determine the proportion of new CKD patients who receive information about treatment     options prior to commencing dialysis, pre−emptive transplantation or conservative management.     To determine the timing (i.e. patient's stage of disease) when information is given. To find     out whether patients have a friend or family member with them when information is given.      Research Design and methods: This study is an assessment of CKD education practices.     Nephrologists and pre−dialysis coordinators from each renal unit will complete questionnaires     about information that was given to each new dialysis, pre−emptive transplant or     conservatively managed patient that started treatment during a 3 month period.      Study hypothesis: Approximately one third of CKD patients will receive information after     starting treatment. There will be a positive association between in−centre haemodialysis and     later referral, non−English speaking background, and advancing age. Significance: The results     from this national audit will provide Australian nephrologists and renal nurses with evidence     about CKD education practices and compliance with clinical practice guidelines. The results     may highlight opportunities for improvement in practice.   "
151703|NCT01298102|"     In 2009, the pandemic influenza A/H1N1 accounted for worldwide recommendations about     vaccination. There is no data concerning the immunogenicity nor the security of the     adjuvanted-A/H1N1 vaccine in renal disease patients. The aim of this study is to observe the     effects of this vaccine on transplanted and hemodialyzed patients.   "
151704|NCT01298089|"     A study of flap thickness predictability in patients submitted to Laser in Situ     Keratomileusis (LASIK) with the Carriazo-Pendular microkeratome (130 micrometers head size).   "
151705|NCT01298076|"     The specific aims of the study are to test the following hypotheses:        -  That there is a difference in change in visual acuity resulting from treatment with          intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced          macular oedema        -  That there is a difference in degree of resolution of macular oedema resulting from          treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes with          advanced macular oedema        -  That both intravitreal bevacizumab and dexamethasone implants have a manageable and          acceptable safety profile in eyes with diabetic macular oedema   "
151706|NCT01298063|"     Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at     highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose     or two lower doses) and 8 healthy matched controls to each of this two groups.   "
151707|NCT01298050|"     Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the survival     rate in patients with refractory cardiac arrest (CA). Recent studies have also highlighted     the potential early application of this method in improving the prognosis of prolonged     cardiac arrest both for in hospital CA (INHCA) and out of hospital CA (OHCA). The rationale     for use of ECMO in these patients is to optimize early perfusion of vital organs, curing the     cause of CA and waiting for the recovery of the injured myocardium. The investigators have     created a flow-chart to decide which patients are eligible. The aims of this study are to     evaluate if, with this flow-chart, the investigators are able to detect which patients have     more probability of survival.   "
151712|NCT01297985|"     This randomized controlled trial tests the efficacy of a mental health peer-led educational     intervention called BRIDGES (Building Recovery of Individual Dreams and Goals through     Education and Support). The BRIDGES program is a 10-week, manualized education course     designed to provide basic information about the etiology and treatment of mental illness,     self-help skills, and recovery principles in order to empower participants to return to     valued social roles within their communities. BRIDGES is a peer-led program and all     instructors are adults with mental illnesses.      Hypothesis #1: Compared to wait-list controls, intervention participants will report     increased feelings of psychological empowerment.      Hypothesis #2: Compared to wait-list controls, intervention participants will report     increased feelings of hopefulness.      Hypothesis #3: Compared to wait-list controls, intervention participants will report enhanced     coping ability.      Hypothesis #4: Compared to wait-list controls, intervention participants will report enhanced     recovery.      Hypothesis #5: Compared to wait-list controls, intervention participants will report greater     ability to advocate for themselves with health care providers.      Hypothesis #6: Compared to wait-list controls, those in the BRIDGES education course will     report increased knowledge of the causes and treatment of mental illness and recovery     principles.   "
151714|NCT01297959|"     This study is intended to determine the efficacy of topical application of E-101 Solution     directly into the surgical incisional wound in the prevention of infection of superficial and     deep surgical incisional wounds. E-101 Solution is an enzyme-based antiseptic that is being     developed for direct application to a surgical incision.   "
151715|NCT01297946|"     Recent developments of continuous glucose sensors and insulin infusion pumps have motivated     the research toward closed-loop strategies to regulate glucose levels in patients with type 1     diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a     computer-generated recommendation that relies on continuous glucose sensor readings. In this     study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop     strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII)     therapy in regulating glucose levels during an evening exercise and on a night following an     exercise in adults with type 1 diabetes.   "
151716|NCT01297933|"     A compassionate use protocol to provide Omegaven to pediatric patients with parenteral     nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).   "
151717|NCT01297920|"     The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic     suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual     active components in subjects with open-angle glaucoma and/or ocular hypertension.   "
151718|NCT01297907|"     Background: Latent pulmonary involvement is described in Crohn Disease(CD). Bronchial     hyperreactivity measured by the Methacholine Challenge Test (MCT) has been evaluated in two     studies involving mainly adults.Our aim was to determine the frequency of bronchial     hyperreactivity in pediatric patients followed and treated for Crohn disease.      Methods: Twenty-three children with Crohn disease completed a questionnaire, followed by     spirometry, Methacholine Challenge Test (MCT) and determination of Fractional Exhaled NO     (FENO). The control group included patients evaluated for functional cough who had negative     Methacholine Challenge Test (MCT).   "
151719|NCT01297894|"     In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to     mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative     bacterial including MDR A. baumannii In this study, we compare the clinical and     microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A.     baumannii infected patients   "
151720|NCT01297881|"     Pulmonary function tests including spirometry, lung volumes, measurements of resistance and     diffusing capacity are essential in the diagnosis of several pulmonary diseases. These tests     are an integral part of the diagnosis and treatment of lung diseases, but until now there is     no clear evidence for the use of many of the pulmonary function tests because of a lack of     adequate studies. The obscurity largely pertains to the conditions under which combinations     of the various tests are indicated. Therefore the Belgian Thoracic Society, assembling all     pulmonologists and the pneumology LOK/GLEM‟s, will investigate this matter.   "
151721|NCT01297868|"     Objective The investigators assessed the acute impact of physical exercise on retinal vessel     regulation. This might be of clinical importance if retinal vessel regulation is examined     with the very sensitive method of the dynamic vessel analyzer Design Forty middle aged (age     range 18 to 31 years, mean age 24 years) healthy subjects (26 female / 14 male) had retinal     examinations with static and dynamic vessel analysis prior and after (0.5h, 1.5h, 2.5h)     intense exercise of 20 minutes.   "
151722|NCT01297855|"     In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa     contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin.      In this study, patients with documented MDR. P.aeruginosa or A.baumanii will be allocated to     receive Colistin alone and another group will receive Colistin plus Rifampicin.   "
151723|NCT01297842|"     Adult patients with ESBL-producing Gram negative infections are randomized to receive     ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups     are compared.   "
151724|NCT01297829|"     Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic,     anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV     antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate     route for administration of ibuprofen when the oral route is not preferable. Recent studies     have reported that Caldolor® decreases morphine use and pain at rest and with movement     compared to patients not receiving this drug.      The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30     minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical     hernia repair will result in a >20% decrease in postoperative narcotic use within the first     24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days     after surgery. The use of less postoperative narcotics has been associated with a faster     return of normal bowel function and resumption of normal ambulatory status thus resulting in     improved general well being for the patient.   "
151727|NCT01297790|"     The sensitivity of a persons cough reflex can be measured by getting them to breath in     (inhale) irritant chemicals. The purpose of this clinical research study is to test the     sensitivity of the cough reflex to a variety of chemicals that can be inhaled to see if     coughing responses are different between healthy people and people with respiratory problems     that make them cough.   "
151728|NCT01297777|"     The aim of this study is to evaluate the efficacy in terms of clinical and biological     response rates of Imatinib Mesylate therapy in patients with systemic mastocytosis lacking     KIT mutations.   "
151729|NCT01297764|"     This study will evaluate the feasibility of combining four of the most active agents     available for the treatment of multiple myeloma. Further the investigators will attempt to     assess the activity of this combination.   "
151744|NCT01297556|"     The purpose of this study is to determine if any specific patient characteristics lead to     improved outcome of IBS treatment, when conventional treatment as well as Cognitive     Behavioral Therapy is used in combination.   "
151802|NCT01296789|"     The Surviving Sepsis Campaign (SSC) published 2008 revised guidelines to improve survival of     septic shock patients. For hemodynamic stabilization the SSC recommends distinct treatment     goals. The study hypothesis is that a tissue perfusion guided protocol could reduce the     duration on vasopressor treatment compared to a conventional protocol.   "
153757|NCT01271244|"     The study looked at relationship between escitalopram and heart rate variability and QT     variability in veterans with PTSD.   "
151730|NCT01297738|"     Obesity and insulin resistance may be in part explained by an altered reward system with     changes in the serotonin/dopamine system. These changes might be caused by changes in dietary     habits, especially by an increased intake of liquid sugar and an increase in meal frequency.     The investigators hypothesize that increasing meal frequency compared to increasing meal size     and when consuming a hypercaloric high-sugar diet (HS) compared to a hypercaloric     high-fat-high-sugar diet (HFHS) will result in a reduction in cerebral serotonin and dopamine     transporters and in a more prominent increase in insulin resistance. In addition, the     investigators hypothesize that the changes in insulin sensitivity will be independent of     changes in abdominal (visceral) and liver fat and that changes in insulin sensitivity due to     the dietary manipulation will co-occur with changes in insulin signaling pathways in     peripheral fat and muscle tissue.   "
151731|NCT01297725|"     The purpose of this study is to compare sharp and blunt fascial entry during caesarean     section on the same patient. The study is performed on woman having cesarean section for the     first time and who have not previously had lower abdominal surgery done. The following     parameters are registered:        1. The preferred side evaluated by the patient 3 months postoperatively.        2. The patient evaluated difference in pain on the right vs. left side 1, 3 and 7 days and          1 and 3 months postoperatively.        3. The rate and side of infection.   "
151732|NCT01297712|"     Polyps found during screening colonoscopy have to be removed or at least biopsied. Attempts     to save costs include endoscopic assessment of polyps with regards to differential diagnoses     between adenomas (which have to be removed) and hyperplastic polyps (could be left in place     or removed and not examined histologically). Such a concept would only be feasible if     endoscopy can make the differential diagnosis with high accuracy. Such high accuracy rates -     between 80% and 95% - have been reported from reference centers with specific scientific     interest. The investigators want to test whether these results a) can be reproduced in the     private practice setting performing large-volume screening colonoscopies and b) whether     latest generation endoscopes provide benefit in terms of better accuracy.   "
151733|NCT01297699|"     The purpose is to investigate tocilizumab administration in patients with moderately to     severely or sight-threatening GO (Graves' ophthalmopathy) without response to treatment with     corticoid intravenous pulses. Currently, these patients only have surgery as therapeutic     alternative.      The principal aim of this study is to evaluate efficacy and safety of tocilizumab treatment     in order to provide a better alternative to surgery for this patients.   "
151734|NCT01297686|"     Chronic plantar fasciopathy is a painful condition common in the workplace, particularly for     those workers required to stand for long periods of time, and is typically associated with     point tenderness at heel and arch of the foot. This clinical trial will investigate the     effectiveness of an innovative multi-element exercise program versus the standard of care for     plantar fasciopathy. The observation period will be 12-weeks. Outcomes are determined through     questionnaire and ultrasound imaging. Workers with long-standing plantar fasciopathy who must     stand for prolonged periods of time (i.e. > 6 hours) during their workday will be invited to     participate in this study. After ensuring eligibility, each subject will be randomly assigned     to either the intervention group who will receive a multi-element exercise program, or the     control group who will receive a cortisone injection followed by a stretching program for     their calf-muscles (standard of care). The treatment length for both groups will be 12-weeks.   "
151735|NCT01297673|"     The purpose of this study is to investigate the incidence of reflux in patients with spinal     cord injury in relation to the lesion level, duration of injury and bladder management   "
151736|NCT01297660|"     Most patients with spinal cord injury suffer from bladder dysfunction which may - especially     in the long-term - impair renal function. Improved treatment during the last decades improved     life expectancy and quality of life. This study evaluates the bladder function in the     long-term after spinal cord injury.   "
151737|NCT01297647|"     The purpose of this study is to evaluate the incidence of urinary tract infection after     urodynamic investigation and to identify the involved germs.   "
151738|NCT01297634|"     This study evaluates the diffusion area (cephalic, lateral, medial and caudal points) of the     botulinum toxin type A in the frontal muscle for usual concentrations and dilutions of the     drug. A basal line control and After the application control will be made, and the     investigators will evaluate the drug effects, based on clinical aspects, photographic     registers and through electromyography exam (EMG).      Considering the results of our investigation, the investigators may propose a pattern of     application of BOTULINUM TOXIN TYPE-A Botox® in the frontal area.   "
151739|NCT01297621|"     This prospective controlled trial was designed to determine whether breast reduction may     influence physical activity and sexuality of breast hypertrophy women.   "
151740|NCT01297608|"     This is a double blinded cross over study. Approximately 20 spinal cord injury patients will     be participating in this 4 weeks study.The primary outcome is difference in fecal     incontinence as recorded in diaries, between the treatment period and the treatment period.   "
151741|NCT01297595|"     This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over     single-dose study employing administration of two oral formulations of crizotinib (OLF and     FC) in the fasted state to healthy adult subjects. Twenty-two (22) subjects will be enrolled     to obtain at least 20 evaluable subjects who complete the study. Each subject will receive     two treatments (A and B) with a washout period of at least 14 days between each treatment.   "
157525|NCT01221779|"     The purpose of this study is to determine if non-invasive electrical brain stimulation can     enhance the out of intensive language therapy in chronic aphasia   "
151742|NCT01297582|"     The primary objective of this study is to evaluate the safety and tolerability of ONO-6950     across ascending single doses in healthy adult male and female subjects. The secondary     objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950     by measuring plasma concentrations of ONO-6950, pulmonary function, and potential     cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a     meal upon the pharmacokinetic profile of ONO-6950.   "
151743|NCT01297569|"     This study is designed to explore a more individualized treatment regime based on achievement     of disease stability to define a personal optimal treatment interval with ranibizumab in     patients with visual impairment due to diabetic macular edema.   "
151745|NCT01297543|"     Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to     accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in     patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid     leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this     study, the safety, tolerability and activity of CLT-008 administered after standard of care     cytarabine-based consolidation or induction/re-induction chemotherapy will be determined by     monitoring for adverse reactions, infusion reactions, graft-versus host disease (GVHD),     neutrophil and platelet recovery, hMPC persistence, infections and complications.   "
151746|NCT01297530|"     This is the first study of this drug in human beings. Every patient will receive the drug,     there is no placebo group. Patients with advanced tumors will be treated. Different groups of     patients will receive different dosages to determine the safety and maximum tolerated dose     (MTD) of BAY87-2243. The study will also assess how the drug is metabolized by the body, its     biologic effects in the body, and changes in tumor size.      BAY87-2243 will be given as a tablet which dissolves in the gut. Based on findings from this     study it may be later given as a tablet which dissolves in the stomach.      BAY87-2243 will be given per mouth, once a day, every day. Treatment will stop if the tumor     continues to grow, if side effects occur which the patient can not tolerate or if the     patients decides to exit treatment.      The study will be conducted in 3 - 4 centers in 3 countries (Norway, United Kingdom and     Germany). The study will have a part where doses are escalated in different groups of     patients. Each dose level will be evaluated in a new group of 3 - 6 subjects. This will be     followed by an extension part where patients are treated at the highest tolerable dose in     groups of up to 25 patients. The extension part will be described in an amendment to the     study protocol later. The number of subjects estimated for this study will depend on the     number of groups enrolled. The starting dose will be 5 mg given orally as a tablet     formulation.   "
151747|NCT01297517|"     The purpose of this study was to evaluate the efficacy and safety of a fixed combination of     Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its     individual active components in patients with open-angle glaucoma and/or ocular hypertension.   "
151748|NCT01297504|"     The study was designed to gather information regarding the use of palivizumab for the     prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected     countries within Latin America.   "
151749|NCT01297491|"     The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured     by determining the progression free survival (PFS), in patients with pretreated metastatic     Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be     investigated in two groups of NSCLC patients according to the histology of the cancer:     squamous and non-squamous.   "
151750|NCT01297465|"     This is a multicenter, multi-national, randomized, open-label comparative trial. After     screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle.     Down-regulation treatment will start within 2 months following the screening visit. The     routine long luteal phase protocol for gonadotropin-releasing hormone (GnRH) agonist     treatment will be followed. Once down-regulation has been confirmed, a pregnancy test will be     performed just before randomization and start of recombinant human follicle-stimulating     hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative,     the subject will be randomly assigned to one of the two treatment arms of the trial:        -  GONAL-f®: (Liquid Pen; 300 international unit [IU] of per day) stimulation Day 1-5          followed by Pergoveris® (vial/powder, 300 IU per day) from stimulation Day 6 and until          required recombinant human chorionic hormone (r-hCG) criterion is met. The dose can be          adjusted from stimulation Day 6 (increased or decreased) based upon the subject's          ovarian response and according to the center's standard practice.        -  Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required          r-hCG criterion is met. The dose can be adjusted from stimulation Day 6 (increased or          decreased) based upon the subject's ovarian response and according to the center's          standard practice.      Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular     development will be monitored according to the center's standard practice by ultrasound (US)     and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least one     follicle greater than or equal to [>=] 18 millimeter [mm] and two follicles >=16 mm). After     this, a single injection of r-hCG will be administered in order to induce final oocyte     maturation.      At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally     under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days     after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), embryo transfer (ET)     and luteal support will be performed as per center's standard practice.      A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant     and non- pregnant) on Day 15-20 post-hCG. For subjects who have withdrawn from treatment     (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take     place 20-30 days after their first Pergoveris® or Gonal-f® treatment injection (excluding     pregnancy testing).   "
151751|NCT01297452|"     The purpose of this study is to find out the good and bad effects that occur when BKM120 is     added to standard chemotherapy with carboplatin and paclitaxel.   "
151752|NCT01297439|"     Shoulder dystocia is a major obstetric emergency defined as a delivery requiring maneuver in     addition to downward traction on the fetal head for delivery of the shoulders. Shoulder     dystocia is a major obstetrical complication, occurring in approximately 0.2 to 3% of     deliveries, principally due to fetal macrosomia. The obstetrical and neonatal complications     associated with shoulder dystocia include newborn mortality occurring in 21 to 290 per 1000     deliveries, generalized asphyxia, fractures, neurological damages (brachial plexus injury)     and hematoma. The objective of this study was to evaluate the pushing maneuver, that is     performed gently on the fetal head since the crowning of the head (appearance of the fetal     scalp at the introitus between pushes), aiming to facilitate the anterior shoulder to slip     off behind the symphysis pubis, reducing thus the risk of shoulder dystocia. This preventive     maneuver may reduce the power (energy/time unit) exerted on the perineal tissues and give the     shoulders time to enter the pelvic cavity. The pushing maneuver will be evaluated in     comparison with either an expectative attitude or a suctioning of fetal nose and mouth.   "
159961|NCT01189773|"     Prospective study to evaluate the additive value of codeine on ibuprofen in the management of     pediatric patient with a trauma of a limb.   "
151756|NCT01297387|"     This observational prospective study will evaluate, according o usual local clinical     practice, feasibility of endoluminal revascularization in diabetic patients with type C and D     lesions, according to TASC II Criteria.      About 300 patients will be treated with usual revascularization procedure. Each patient will     be followed at least 12 months to evaluate clinical outcome and limb salvage interventions.   "
151757|NCT01297374|"     The purpose of this study is to compare the effect of three different non-pharmacological     interventions (usually practiced in ambulatory care of Childhood Obesity (AmO), physical     activity program (IFSP) and diet therapy adjusted estimate by indirect calorimetry) on the     percentage of body fat and basal metabolism of children and Overweight and obesity in the     metropolitan region of Porto Alegre (RS).   "
152295|NCT01290354|"     The purpose of this study is to find out how much lapatinib can enter both normal brains and     brains in which tumours secondary to breast cancer have developed.   "
151758|NCT01297361|"     Vitamin B12 deficiency is more widespread in the population than has been assumed so far.     Since a deficiency in this vitamin can lead to irreversible neurological damage, early     diagnosis is essential. Vitamin B12 is synthesized exclusively in micro-organisms, and in     humans it is an essential component in methyl group transfer and cell division. The vitamin     is crucially involved in the proliferation, maturation, and regeneration of neural cells. In     combination with folic acid, as an enzymatic essential cofactor in the metabolism of     homocysteine, vitamin B12 maintains low homocysteine levels. The aim of the present study is     to investigate the relationship between religious origin and age, and Vitamin B12 and Folic     acid plasma levels in non Jewish population in Western Galilee. The investigators assumption     is that the results of the study will contribute to early detection and treatment of Vitamin     B12 and Folic acid deficiencies in order to prevent long term complications.   "
151759|NCT01297348|"     Lybrel® is an oral contraceptive that delivers low doses of levonorgestrel and ethinyl     estradiol (90 μg/20 μg). Lybrel is taken on a continuous basis without a placebo or pill-free     interval to inhibit menstrual cycle bleeding by delivering a steady level of the 2 hormones     for as long as the drug is used. Lybrel was marketed in the US in July of 2007. The objective     of this database case-control study is to estimate the risk of idiopathic VTE (deep vein     thrombosis and pulmonary embolism) in current users of Lybrel (ethinyl estradiol     20ug/levonorgestrel 90ug) compared to current users of other oral contraceptives containing     20μg of ethinyl estradiol.   "
151760|NCT01297335|"     The purpose of this study is to determine the acute efficacy of intrathecal clonidine to     reduce blood pressure in hypertensive subjects with poor blood pressure control and describe     its effects on cardiovascular function.   "
151761|NCT01297322|"     The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva     VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis:     The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA)     results that are less than manual compression by a clinically meaningful and statistically     significant margin. The rate of major access site-related complications with the Cardiva     VASCADE™ VCS is non-inferior to the major complication rates of manual compression for     sealing femoral arterial access sites.   "
151762|NCT01297309|"     This study is a long-term, open-label study using NPSP558 for the treatment of adult patients     with Hypoparathyroidism.   "
151763|NCT01297296|"     The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant     and Delivery System in the partitioning of the left ventricle in patients with heart failure     due to ischemic heart disease.   "
151764|NCT01297283|"     The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta     CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from     the device programmer (PECG) or an external ECG machine.      The purpose of the study is to obtain more data on leadless ECG to determine whether LECG     during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it     can be used during remote follow-up evaluations.   "
151765|NCT01297270|"     The objective of this trial is to evaluate the efficacy and safety of two different treatment     regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care     (SOC) with PegIFN/RBV alone.   "
151766|NCT01297257|"     The primary objective of the DELIVER Study is to assess the deliverability of the Resolute     Integrity Stent as primary stent or as a secondary cross-over stent following delivery     failure of another stent type in real world patients.   "
151767|NCT01297244|"     This is an open-label, single arm, multicenter study. Subjects will be stratified by     histology (clear cell vs. non-clear cell). Enrollment of non-clear cell subjects will be     limited to ≤ 30% of the entire study population.   "
151768|NCT01297231|"     Tamoxifen is a hormonal treatment for breast cancer. It prevents recurrent disease and     decreases death. Tamoxifen is given to women with and at high risk for breast cancer. These     women also commonly have breast MRI to monitor for breast cancer. Some features of normal     breast tissue visible on breast MRI change depending on patient hormonal status. It has been     questioned if hormonal changes due to tamoxifen are seen on breast MRI. Pilot data suggests     this is true. If tamoxifen causes changes in normal breast tissue on MRI, more study could be     done looking at whether breast MRI could tell us anything about whether tamoxifen is working.      This study is being done to see if tamoxifen changes normal breast tissue on MRI. It will     also look at if other factors like taking anti-depressants or gene type have any effect.   "
151769|NCT01297218|"     The primary purpose of this study is to evaluate the safety and the tolerability of     NEUROSTEM®-AD (Human Umbilical Cord Blood Derived Mesenchymal Stem Cells) and to assess the     maximum tolerated dose (MTD). This study is also to investigate the efficacy of this study     drug in patients with dementia of Alzheimer's type.   "
151770|NCT01297205|"     PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended     to treat premature infants with bronchopulmonary dysplasia. This study is to assess the     safety and the efficacy of this study drug.   "
151771|NCT01297192|"     This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of     solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.   "
151772|NCT01297179|"     The objective of this study is to determine the effect of multiple doses of mirabegron on the     pharmacokinetics of an oral contraceptive.   "
152014|NCT01294007|"     The purpose of this study is to evaluate the rate and quality of fusion of PureGen     Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral     fusion (PLF) procedures.   "
151799|NCT01296828|"     Purpose: to characterize the posture, tone and mobility of lips and tongue of mouth breathing     children.      Methods: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and     10 years old, were involved in this research realized in São Paulo, SP, Brazil . It was used     the MBGR protocol to evaluate the posture, tone and mobility of lips and tongue of mouth     breathing children.   "
151800|NCT01296815|"     Kaposi sarcoma remains the most common malignancy among persons with HIV.      Lesions localized to the airway may cause bleeding, pain and dyspnea.      New therapeutic approaches for local disease are needed.      The purpose of this study is to compare the effectiveness of intralesional bevacizumab +     HAART vs HAART alone in treating localized Kaposi´s sarcoma of the airway in patients with     AIDS.   "
151775|NCT01297140|"     Alzheimer's disease is characterised by a loss of cognitive functions and behavioural     problems as set out under the term Behavioural and psychological symptoms of dementia     (BPSD). The impact of BPSD in everyday life has heavy consequences for the patient and their     family. The precocity of incidence, the frequency and the intensity of the BPSD are     associated with a rapid decline in cognitive functions, an alteration in the activities of     daily living, and a decrease in the quality of life for both the patient and the helper, an     increased risk of hospitalisation and of institutionalisation as well as an increase in the     cost to the health system. A greater understanding of the risk factors for the occurence of     the BPSD would better allow the detection of patients who are particularly at risk for BPSD,     to anticipate the crisis situations by proposing early and adapted care, and to better target     the medicinal therapies. Certain observational arguments or results of retrospective studies     speak in favour of the role of the basic personality in the occurence of BPSD in Alzheimer's     disease. The investigators propose to clarify this role through a prospective study.   "
151776|NCT01297127|"     This prospective observational study will evaluate predictors of response to Invirase     (saquinavir) treatment in treatment-naïve patients with HIV infection. Data will be collected     during 48 weeks of treatment.   "
151777|NCT01297114|"     This investigation is designed to study how the brain functions when it is performing     explicit memory tasks, and furthermore how the brain systems supporting performance on these     tests change as a function of aging. Implicit memory tasks may be distinguished from explicit     memory tests in that explicit memory characterizes the directed or intentional recollection     of previously learned information or events. In contrast, implicit (or nonconscious) memory     is expressed in the facilitation of performance on some task or judgment on a stimulus owing     to a prior presentation of that stimulus, without any necessary conscious awareness of the     prior presentation. The investigators propose to use functional Magnetic resonance Imaging     (fMRI) to measure brain activity during the performance of carefully designed explicit memory     tasks. Comparison of brain activity during the different test conditions will provide     information about the brain areas that are involved in mediating specific aspects of     performance. Both older and younger individuals will be tested in order to understand age     related changes in the brain activity. In order to examine the interactions between     participants' differential levels of amyloid burden and their performance on cognitive tasks     and fMRI neural activation, the investigators also propose PET imaging of older participants.   "
151778|NCT01297101|"     The aim of this study is to investigate the efficacy and safety of Tarceva versus combination     of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage IIIA-N1,N2     NSCLC with EGFR activating mutation in exon 19 or 21.   "
151779|NCT01297088|"     The study will be conducted as an open label, single-center, single dose and biodistribution     study in patients with cancer or inflammation. 56 patients will be selected among the     patients undergoing the screening examination conducted within 3 weeks before drug     administration. Single dose of the study drug will be administrated in a dose of 300 MBq to     these patients. The follow-up period contains the end-of-study telephone interview 5-8 days     following the treatment. Key measurements are the PET/CT image acquisitions within a time     frame of about 2 hours after the single injection of BAY86-9596.   "
151780|NCT01297075|"     The aim of this project is to motivate and support general practice clinics in implementing     the visions and recommendations presented in two of the disease specific programmes for     chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These     programmes describe evidence based treatment and division of tasks between the     municipalities, the hospitals and general practice.      The Facilitator Project is funded by The Danish Ministry of Interior and Health.   "
151781|NCT01297062|"     Compare the effect of exenatide (therapeutic and supratherapeutic concentrations),     moxifloxacin and placebo on the QT interval.   "
151782|NCT01297049|"     The overall objective of this pilot study is to develop a cost-effective treatment     methodology delivered outside of traditional clinical setting, and based on modern technology     for patients with diabetes type 2 also suffering from obesity. This study will investigate     the feasibility of web based counselling and situational feedback through mobile supervising.     The intention is to treat 10-15 patients. All participants will receive standard treatment     delivered by their general practitioners. In addition the participants will fill in and send     diaries to the supervisors each evening for 4 weeks reduced to a weekly frequency for the     next two months period. The diary's schedule will be an evaluation of the day activities     related to meals and food, medication management as well as the performed physical     activities. The diary's schedule will also include blood glucose sample, and plans for the     next day especially regarding physical activity. The participants will be able to view their     own registrations on a web page. Daily/weekly situational feedback will be given to the     participants within a cognitive behavioural framework to stimulate self-management. The     primary outcome will be the HbA1c levels. Secondary outcomes will include evaluation of     lifestyle outcomes such as physical activity levels and eating behaviour, and skills such as     self-management of medication. In addition, the interventions effectiveness will examine     mental health outcomes such as emotional distress and health-related quality of life.   "
151783|NCT01297036|"     To compare the relative bioavailability and pharmacokinetic characteristics of a newly     developed donepezil formulation with a conventional formulation in healthy subjects with a     single dose, randomized, open-label, 2-sequence -2period crossover study.   "
151784|NCT01297023|"     The study was conducted to investigate the effect of vitamin d3 alone and in combination with     calcium phosphate on bone metabolism and further physiological parameters in healthy     subjects. It is postulated that calcium phosphate beneficially influences the bone specific     action of vitamin d3.   "
151797|NCT01296854|"     The primary objective of this study is to measure and compare the number of exacerbations     (moderate or severe) between the two groups of randomized patients with and without thermal     treatment). An exacerbation is defined by an increase in symptoms which justifies a     unscheduled medical action: increased daily treatment and / or use of corticosteroids, and /     or antibiotic therapy. Exacerbations are documented via prescriptions, hospitalisation     reports or unscheduled visits.   "
153100|NCT01279785|"     This is a single arm, open label study of up to 20 patients with prostate cancer scheduled     for prostatectomy at the NIH Clinical Center. 123I-MIP-1072 image data will be evaluated for     visible uptake and compared with histopathology.   "
151785|NCT01297010|"     The majority of pediatric surgery takes place in an outpatient basis. The occurrence of     postoperative vomiting can lead to a delay in hospital discharge. However, the use of     postoperative vomiting prophylaxis exposes patients unnecessarily to the drugs side effects     and also raises the final costs of the surgical procedure. The Objective our study is Compare     the incidence of postoperative vomiting between children who received dexamethasone,     dexamethasone plus ondansetron or placebo for anti-emetic prophylaxis during outpatient     surgery. This is a randomized, double blind, placebo-controlled study to comparing the use of     dexamethasone, dexamethasone plus ondansetron and placebo for postoperative vomiting     prophylaxis in children submitted to general anesthesia. Data analysis will be used is     Fisher's exact test for the categorical variables and the Anova test for numerical variables     as they presented Gaussian variation. The study used a significance level of 5%.   "
151786|NCT01296997|"     The study was conducted to investigate the effect of a calcium phosphate supplementation on     the secretion of incretins.   "
151787|NCT01296984|"     The aim of the project is to evaluate the oncological and functional outcome of the more     extensive perineal dissection - i.e the extra levator resection - in abdominoperineal     resections in patients with rectal cancer.      Hypothesis: Extra levator perineal resection reduces local recurrence three year     postoperatively compared to traditional abdominoperineal resection and improves QoL 2-4 years     postoperatively.   "
151788|NCT01296971|"     This open-label, non-comparative study will assess the safety and tolerability of     individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon     alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype     1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For     patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48     weeks. Patients who had previously received standard or pegylated interferons but were     non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for     up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given     to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week     follow-up.   "
151789|NCT01296958|"     The purpose of this study is to determine whether screening and treatment of tapeworm     carriers can decrease community transmission of Taenia solium parasitic infection.   "
151790|NCT01296945|"     Providing child nutrition information is a major goal of every pediatric well-child visit.     Unfortunately, due to a wide array of issues, doing this effectively during clinic visits is     challenging and insufficient. It is because of this that some have looked for innovative ways     to enhance the delivery of this information. One such way is the use of touch screen computer     programs containing nutritional information. Several studies have documented the value of     patients receiving health information in such a manner.      Nonetheless, the use of this medium has not been well studied in Spanish-speaking care     providers of young children. The investigators recently conducted a study that evaluated     user's perception of the usability of such technology, finding that most users thought that     the touchscreen was easy to use, despite their low computer confidence levels. The     investigators also evaluated the impact of using nutrition modules on user's nutrition     knowledge, finding that immediately after use; participant's nutrition knowledge was     improved. I now propose to evaluate this technology further through a 4 armed randomized     controlled trial. The goal here is to evaluate the longer term impact of the educational     modules on nutrition knowledge and the impact, if any, of additional web access to the     modules, on longer term knowledge. A secondary goal is to better understand nutritional     habits in this population and perceptions of weight.   "
151791|NCT01296932|"     Adult patients with chronic lymphocytic leukaemia who experience a relapse after at least two     prior treatment regimens may be enrolled in this trial. The trial will examine whether     monotherapy with BI 836826 is safe and tolerable at escalating dose levels.   "
151792|NCT01296919|"     Given that the uncinate process is the gatekeeper of the sinuses, we hypothesize that     inflammation of the uncinate process is associated with decreased ventilation and drainage of     the paranasal sinuses and consequently with the inflammatory process occuring in the sinuses.   "
151793|NCT01296906|"     One of the nation's major health priorities, as outlined in Healthy People 2010, is to     increase the proportion of children aged 19 to 35 months who have received all universally     recommended vaccines. This study will compare two interventions for increasing immunization     rates in this age group, one using well-studied primary care practice-based methods and the     other using innovative technologies to increase immunization rates at the population-level.     Results of this study will provide data that will be relevant nationally in guiding future     investment of resources to increase up-to-date rates in young children prior to school entry.      Hypothesis: Population-based approaches will be more effective than practice-based     interventions at increasing immunizations among 19-35 month olds.   "
151794|NCT01296893|"     Following chemotherapy, some breast cancer survivors report alterations in their ability to     remember, concentrate, or think, which can have significant emotional, psychological, and     economic impact on their lives. Survivors have also reported feeling frustrated by the     response of the medical community, who either may not acknowledge their symptoms or have no     treatment options to suggest. Exercise may be a promising treatment, as improvements in     cognitive function with exercise have been demonstrated in older adults and other clinical     populations.      The investigators will recruit women who have completed chemotherapy for breast cancer     (within the past 2 years) and report cognitive changes. Women will be randomly assigned to     either a 24-week aerobic exercise intervention or delayed exercise control (offered the same     exercise program following the study). At the start and end of the study the investigators     will measure: i) performance on four standard neuropsychological tests that measure working     memory, learning, and problem solving; ii) a questionnaire on cognitive function and its     impact on quality of life; iii) functional magnetic resonance imaging (fMRI) during two of     the standard neuropsychological tests which provides information on how the brain is working     during the tests.      To knowledge of the investigators this is the first study to examine the effect of an     exercise intervention on cognitive function in breast cancer survivors. In addition, the use     of fMRI imaging is a new way to approach this research question, and may be more sensitive to     change than traditional measures of cognitive function.   "
151795|NCT01296880|"     The purpose of this study is to determine the effect of lacosamide on mood and quality of     life in people with epilepsy.   "
151803|NCT01296776|"     Although there is some evidence that whole body electromyostimulation(WB-EMS) affect bone via     its acute and longitudinal effects on muscle mass and strength, the corresponding impact on     bone density and falls in older adults has not been assessed yet. The investigators     hypothesize that WB-EMS significantly affects bone parameters as assessed by DXA, and     significantly reduce fall rate and ratio in a cohort of frail elderly women.   "
151804|NCT01296763|"     Patients whose pancreatic cancers have defects in the BRCA/Fanconi DNA repair pathway or     other defects in homologous repair will have cancers that respond to olaparib when given in     combination with the DNA damaging agents, irinotecan, cisplatin, mitomycin C (ICM).   "
151805|NCT01296750|"     A knee dislocation is an unusual and extremely serious injury and is defined as complete     displacement of the tibia with respect to the femur, usually with disruption of 3 or more of     the stabilizing ligaments. When the knee dislocates, there is often significant damage to the     soft-tissues envelope surrounding the joint, including adjacent neurovascular structures. Not     surprisingly, this injury is a profoundly debilitating, life-altering event, with the     potential to necessitate career change in athletes and laborers alike. Current evidence     indicates that operative management for these injuries is more effective at returning     patients to pre-morbid range of motion (ROM) and activity than conservative management. Post     operative rehabilitation programs for these patients must balance the need for stability of     their surgical repair and knee ROM and functionality. Experimental data suggests that     post-operative immobilization offers greater protection of the surgical reconstruction,     whereas immediate, aggressive physiotherapy may be more effective at preventing     arthrofibrosis stiffness. The investigators are proposing a randomized clinical trial     comparing early physiotherapy (day one post op) versus immobilization for three weeks then     initiation of physiotherapy. The physiotherapy progams will be identicalbe in all aspects     except for progam initiation.   "
151806|NCT01296737|"     The purpose of this study is to validate the use of DSPECT camera for the performance of     quantitative spect ventricular function imaging by comparison to a validated procedure     performed on standard nuclear cameras.   "
151807|NCT01296724|"     Abdominal Compartment Syndrome (ASC) is defined by an Intra Abdominal Hypertension (IAH)     associated with a new organ failure. The occurrence of this syndrome is not well known in     infants. Preterm birth is frequently associated with gastrointestinal complications,     particularly Necrotizing Enterocolitis. In this pathology it is likely that the intra     abdominal pressure (IAP) increases and can participate in the occurrence of organ failures.     Newborn, in particular with digestive malformation as diaphragmatic hernias, gastroschisis,     could themselves be suffering from this syndrome. It would be interesting to make early     diagnosis in order to optimize the management of these children. This requires reliable     measurements methods and standards. Intravesical Pressure (IVP) is the most reliable     validated indirect method to measure intra-abdominal pressure. In order to measure the IVP,     the bladder must contain a minimum of liquid. However, using inappropriate volumes could give     erroneous IAP readings. The optimal amount of saline to inject in older children, determined     from pressure-volume curves study is 1 ml/kg. In preterm and term infants, this volume appear     extremely low (e.g. 0 8cc if taking a child to 800 g). The question that arises is whether     this quantity is sufficient to obtain reliable and reproducible measurements of IVP in     preterm and term.   "
151808|NCT01296711|"     The purpose of this study is to evaluate the long term safety and tolerability of CDP6038     treatment in adult subjects with active rheumatoid arthritis (RA) who completed RA0056.   "
151809|NCT01296698|"     This study is to see if a new nicotine replacement therapy safely helps people to quit     smoking if it is used the way it would be if it were sold at the pharmacy and used at home.     Approximately 1500 subjects will be enrolled into the study. The study will require     participants to use the treatment for 12 weeks and there will be a 14-week follow-up period.     The study will be conducted in approximately 20 pharmacies across the United States.      At the first visit to the pharmacy, participants will be asked some questions to see if they     are eligible to participate. Participants will be asked to sign a consent form if they agree     to participate. Participants will answer some more questions, and blow into a machine to     measure their carbon monoxide (CO) levels to make sure they qualify for the trial.     Participants will be asked to go to a nearby dentist who will look at their mouths.     Participants will go back to the pharmacy and if they qualify, they will be given a supply of     their assigned treatment. They will have an equal chance of receiving a treatment that has a     drug in it or one that has no drug in it. They will be given a diary to keep track of how     much of the treatment they use.      Subjects will go to the pharmacy four more times to hand in their diaries and blow into a     machine that will measure their CO levels. At the last visit, subjects will have their mouths     examined by a dentist again to have their mouth checked.      Subjects will receive four telephone calls during the study where they will be asked some     questions.      After the 12 week treatment period, subjects will receive two to three more telephone calls,     where they will be asked to answer some questions. Participants may be asked to come back to     the pharmacy two more times to blow into the carbon monoxide machine again.   "
153583|NCT01273506|"     The purpose of this study is to evaluate the bioequivalence of a 50-mg tapentadol (CG5503)     dose administered as two 25-mg ER, TRF tablets relative to one 50-mg ER TRF tablet in healthy     Japanese male participants.   "
151810|NCT01296685|"     The goal of the study is the evaluation of the air handling of a new type of oxygenator     versus the standard model. The new type has an integrated arterial filter. The standard model     has a non integrated arterial line filter. If the air handling is as effective/ better than     in the standard model this can lead to reduction of cardiopulmonary bypass circuits with     their initiation of systemic inflammatory response and improve cardiopulmonary bypass safety.   "
151811|NCT01296672|"     The investigators will propose a novel method to improve prostate cancer screening with PSA,     using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia     (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will     also examine three additional promising tests that may further improve diagnosis of prostate     cancer.   "
151812|NCT01296659|"     Ridaforolimus has been tested in almost 2 dozen studies; however, it has not previously been     tested in combination with the standard of care chemotherapy for sarcoma as this study will.     We will be looking to see if Ridaforolimus given with SOC chemo (AIM or TG) is well tolerated     and to determine a Phase 2 dose.   "
151813|NCT01296646|"     Purpose: The proposed 2-year investigation will be the first double-blind, placebo-controlled     trial examining the hedonic response to sweet taste (HRST) as a phenotypic predictor of     naltrexone (NTX) response in alcohol dependence. HRST yields two primary phenotypes—Sweet     Likers (SL) and Sweet Dislikers (SDL). Based on preliminary findings, HRST will be examined     in conjunction with craving for alcohol to assess whether the two factors together provide a     more robust predictor of NTX response. The identification of methods to predict naltrexone     response in alcohol dependence is an important goal for alcohol treatment research. Currently     naltrexone is not being used nearly as much as it should be, in part because clinicians do     not believe it is very effective. The development of tools that would identify which patients     are more likely to have a robust response to naltrexone should lead to increased use of the     medication. This could help many patients who are not now having the opportunity of trying     naltrexone.      There are two principal Specific Aims for the study:      Specific Aim 1. To test the hypothesis that a combination of SL/SDL status and initial     alcohol craving will predict % abstinent days (%ABST) during treatment with naltrexone.      Specific Aim 2. To test whether a combination of SL/SDL status and initial alcohol craving     predict % heavy drinking days (%HDD) during treatment with naltrexone.   "
151814|NCT01296633|"     The broad goal of this project is to improve knowledge of and adherence to medication     regimens and health outcomes among adults with type 2 diabetes or other metabolic disorders.     These patients have complex self-care needs, but limited literacy and cognitive skills to     meet these needs. Medication error is widespread and costly, and often associated with     inadequate patient knowledge about medication, especially among chronically ill adults with     limited health literacy. Inadequate knowledge is often traced to limited communication with     providers, in part because of barriers such as limited patient contact time and communication     training, and lack of system-level support for consistent use of patient-centered strategies.     There is a need to leverage information technology (IT) to provide system-based support for     patient-centered communication. The investigators will evaluate an Electronic Medical Record     (EMR)-based tool (the Medtable) to support provider/patient communication and improve     medication knowledge, adherence, and health outcomes among chronically ill adults with     complex medication regimens. A paper-based Medtable has been found to help older adults     create accurate medication schedules in a simulated patient/provider communication task     (Morrow et al., 2008). Benefits for patients should be enhanced if the Medtable is integrated     with an EMR, giving providers ready access to relevant background information and current     medication lists that patients can update, so providers can generate and tailor the Medtable     for a diverse set of patients. This system provides an integrated approach to patient     education about medications, from prescribing to counseling during office visits. As a     result, patients would not only understand how to take their medications, but develop     concrete plans for doing so. Specific aims of the project are: 1) Refine the Medtable     prototype for use in an EMR environment. This includes developing protocols for generating     patient-specific Medtables and educating providers to use them in medical encounters. 2)     Evaluate the Medtable's impact on patient care processes and outcomes. The investigators will     test the following hypothesis about communication processes: H1) Patients in the intervention     condition will be more satisfied with communication about medication than patients in the     usual care condition. The investigators will also test the following hypotheses about patient     outcomes: Compared to usual care patients, patients receiving the Medtable intervention will:     H2) know more about their medications; H3) adhere more accurately to their medication     regimens; H4) more likely have blood glucose (glycosylated hemoglobin, HbA1c) levels in the     target range. Aim 1 will be accomplished by interviewing physicians and their patients as the     system is refined to ensure ease of using the system, and by collecting preliminary evidence     that the Medtable improves patient/provider communication. After establishing initial     feasibility and ensuring provider acceptance of the system, Aim 2 is addressed by a     randomized trial at the general internal medicine clinics in Chicago and Peoria (IL),     comparing patients who use the Medtable with their providers to those receiving usual care.   "
151815|NCT01296620|"     Post-operative administration of ulimorelin is expected to reduce time to recovery of     Gastrointestinal (GI) function in patients who have undergone partial large bowel resection   "
151816|NCT01296607|"     Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem     with a poor prognosis and the search for novel treatments remains an important area of     research.      Urocortins are proteins that appear to increase blood flow and heart pumping activity. There     has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in     heart failure.      In this study, we will examine the pharmacokinetics and pharmacodynamics (in particular the     onset-offset of action and reproducibility of vasodilator effects) of Urocortins 2 & 3 on     forearm arterial blood flow healthy volunteers.      Utilising the well-established technique of 'forearm venous occlusion plethysmography', we     will be able to focus on the local effects of urocortins on arterial blood flow in forearm     vessels, without affecting this system in the body as a whole.   "
151817|NCT01296594|"     Poor adherence to antihypertensive medications is associated with morbidity, and data suggest     that substance abuse may contribute to poor adherence. Contingency management (CM), an     intervention highly efficacious for improving outcomes of substance abusers, shows promise in     improving medication adherence in a handful of small trials. CM involves providing tangible     reinforcement each time the behavior (medication ingestion) is exhibited. Thus far, studies     evaluating CM for increasing medication adherence have utilized MEMS caps, but reinforcement     of adherence via MEMS caps is done relatively infrequently and with delay, hindering its     efficacy. A widely utilized technology that may be more appropriate for reinforcing     medication adherence is cell phones, which can record the process of pill ingestion through     video functions. As regular monitoring and feedback is important in the efficacy of CM,     patients can be provided with daily messages regarding adherence and CM earnings. In this     pilot study, we propose to randomize 40 hypertensive substance abusing patients with     suboptimal adherence to antihypertensive medications to one of two 12-week treatment     conditions: (1) usual care, or (2) usual care with cell phone monitoring and CM. In the CM     condition, patients will carry a cell phone and record and send in time- and date-stamped     self videos of medication ingestion. These patients will receive congratulatory messages or     reminders about adherence, and they will earn vouchers each time medication ingestion occurs     at the appropriate time, along with bonuses for sustained adherence. We hypothesize that the     CM condition will improve self report and pill count measurements of medication adherence and     that it will result in decreased blood pressure. Results from this study may have widespread     implications for the use of cell phones as a novel technology to improve medication     adherence.   "
151818|NCT01296581|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of X-82 as a     single agent.   "
151819|NCT01296568|"     This is an open-label study being conducted to determine the metabolism and physiological     disposition of radiolabeled LY2603618 after a single dose in patients with advanced and/or     metastatic solid tumors.      After a minimum 7-day washout period following the [14C]LY2603618 dose, patients will be     allowed to continue to receive continued access to LY2603618 in combination with pemetrexed     or gemcitabine as outpatients.   "
151820|NCT01296555|"     This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and     pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During     Stage 1, GDC-0032 will be administered every day orally and at escalating doses in     participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will     be administered alone or as combination therapy within indication-specific cohorts. In Phase     II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be     evaluated in post-menopausal female participants with locally advanced or metastatic human     epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.   "
151821|NCT01296542|"     To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the     conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3     days of treatment.   "
151831|NCT01296412|"     This study is being done to compare the effectiveness and safety of two treatment paradigms     (oral sitagliptin with or without glimepiride versus liraglutide with or without increased     dosing) for the treatment of participants with Type 2 Diabetes that is not adequately     controlled with metformin alone. The primary hypothesis postulated that the mean change from     baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment     is non-inferior to that of participants treated with a liraglutide-based      treatment.   "
151847|NCT01296204|"     The first step of this protocol called step pre-treatment study the biodistribution and     pharmacokinetics of a tracer dose of radiolabeled antibody. The second step called step     therapy study the toxicity and antitumor effects of antibody B-B4 coupled with increasing     doses of iodine 131. At least 17 patients will be included for an estimated duration of 2     years to determine the maximum tolerated dose and dose limiting toxicity. The immediate side     effects, medium and long terms will be analyzed. After determining the toxic dose limit,     patients will be treated at the maximum tolerated dose, for a total of 15 patients at this     level, which will measure the objective tumor response to treatment. These patients will be     followed for 1 year after injection therapy.      ÉcouterLire phonétiquement   "
151848|NCT01296191|"     The purpose of this study is to compare drug concentrations in aqueous humor following ocular     instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.   "
151854|NCT01296113|"     This is a phase II, multicenter, non-randomized, open-label study evaluating the combination     of pemetrexed plus carboplatin in HIV-positive patients with lung cancer.   "
151822|NCT01296529|"     Liver-related death is the leading cause of mortality in HIV-infected individuals with CD4+     cell counts over 200, and hepatitis C virus (HCV) infection is the greatest risk for     liver-related mortality in HIV-positive patients. Compared to HCV monoinfected individuals,     patients with HIV and HCV coinfection experience accelerated progression of liver fibrosis,     which can lead to higher incidence of cirrhosis, end stage liver disease (ESLD), and death.     Changes in CD8+ T-cell activation, inflammatory cytokines, and serum markers of tissue injury     may offer an immunologic platform to determine factors associated with progressive liver     fibrosis in coinfected patients. In this cross-sectional study we will evaluate whether HIV     and HCV coinfection patients with well-controlled HIV infection who have an undetectable     viral load exhibit abnormal levels of inflammation and immune activation, potentially     contributing to advanced liver fibrosis. Comparative groups include coinfected patients     successfully treated for hepatitis C, or who have absence of hepatitis C viremia through     spontaneous clearance, hepatitis C monoinfected patients, and HIV-positive patients with     well-controlled HIV infection without hepatitis C. Liver fibrosis will be measured by     non-invasive methods.      The primary objectives of this study are:        1. To determine if there are differences in markers of inflammation and immune activation          in subsets of patients with HIV, hepatitis C, and HIV and hepatitis C coinfection.        2. To assess the stage of liver fibrosis using non-invasive methods in subsets of patients          with hepatitis C and HIV and hepatitis C coinfection and compare the degree of liver          fibrosis with levels of inflammation and immune activation.   "
151823|NCT01296516|"     The overall objective of this pilot project is to test in 50 women with a history of     gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month     intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year     after delivery.   "
151824|NCT01296503|"     This multicenter, prospective, randomized trial was designed to evaluate the role of     thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma     patients after a single autologous stem cell transplantation.   "
151825|NCT01296490|"     Physical exercise has many benefits, although it might also have negative impact on the body,     which changes in accordance with training level, length of workout, age of subject and their     fitness level. These outcomes are governed by complex biological processes, from which     Reactive Oxygen Substances (ROS) are considered the most prominent ones during exercise     activity. These substances harm muscle activity, and might cause other health related damage     by influencing other pathways that engage with free radicals. Excess of ROS, is expressed as     Oxidative Stress (OS), pathogenic process activation and aging. With this in mind, it is     important to remember that ROS are essential to the investigators bodies as well, especially     in gene regulation. Thus they influence proteins that are important for proper muscle     function and the immune system.      Physical exercise induces changes in low molecular weight antioxidants, and in antioxidant     enzymes. According to results that were published in the literature, no universal conclusion     can be made regarding physical exercise effect on antioxidants activity. These contradictions     might be attributed to the difference between the methods that were used, and their quality.      Paradoxically, physical exercise has the same effect on ROS inducement in skeletal muscle     fibers as does not using the muscles for a long period of time (especially as a result of     handicap). It is well known that physical exercise effect oxidative stress and antioxidant.     Due to the doubts that rise from the literature, the investigators think that it is important     to test physical fitness effect on oxidative stress biological markers, using various high     quality methods, on the same population.      The investigators will test healthy men, 20-35 years of age, none smokers with 6-24% fat, who     do not take vitamins or supplements. The men will run on a treadmill for 10 minutes to     exhaustion, and blood will be taken before the test, 5 minutes after the test, and an hour     after the test (checking recovery).   "
151826|NCT01296477|"     There is a mounting body of evidence suggesting that there is a large disparity between the     development and the actual implementation of guideline-driven asthma care in primary and     specialty care practices. To address this disparity, the American Academy of Allergy, Asthma     & Immunology (AAAAI) developed a unique, comprehensive and easy-to-use Web-based tool for     clinicians who treat asthma patients called Asthma Specialist Tool to Help Manage Asthma and     Improve Quality (Asthma-IQ). This study will examine whether the use of the Asthma IQ     primary care tool will improve asthma care and asthma outcomes using a randomized trial of     the Asthma IQ system versus usual asthma care in the primary care setting over 1 year. At the     end of 1 year, all patients will be managed using the Asthma-IQ tool for an additional year     to determine if the patients managed by usual care in the first year improve when managed in     conjunction with Asthma-IQ. The primary endpoint to determine if the use of the Asthma IQ     tool will improve asthma patient outcomes is quarterly assessments of Asthma Control Test     (ACT) scores via automated / electronic patient survey. The secondary endpoint is asthma     exacerbations and there are a number of exploratory endpoints to further define the clinical     utility of the primary care version of Asthma-IQ. This study will involve recruiting     approximately 20 family medicine offices with approximately 20 patients each, to conduct this     randomized, multiple time point intervention trial. The necessary total recruited patient     sample size is 200 per group. The results of this study will help determine the utility of     Web-based tools to help manage chronic diseases such as asthma.   "
151827|NCT01296464|"     The primary objective is to assess the effect of a single dose of two experimental     levodopa/carbidopa/entacapone (L/C/E) treatment regimens versus standard L/C/E treatment     regimen in Parkinson's disease (PD) patients with end-of-dose motor fluctuations in terms of     duration of motor response after the first morning dose of levodopa. The secondary objective     is to evaluate the safety of the L/C/E treatment regimens in patients with PD.   "
151828|NCT01296451|"     The study is aimed at assessing the safety of AdCh3NSmut and the new candidate vaccine     MVA-NSmut when administered sequentially, or alone, to healthy volunteers and patients with     hepatitis C virus infection The study also aims at assessing the cellular immune response     generated by AdCh3NSmut and MVA-NSmut administered as mentioned above.   "
151829|NCT01296438|"     This trial is conducted in Europe. The aim of this trial is to investigate the     pharmacokinetic (the rate at which the body eliminates the trial drug) and pharmacodynamic     (the effect of the trial drug on the body) profiles of NN1218 in comparison with insulin     aspart.   "
151830|NCT01296425|"     This is a National, Multicentre, Observational Registry to study adherence and long term     outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth     hormone treatment from hospitals in Austria and to assess the level of adherence of subjects     receiving SAIZEN® via Easypod™.   "
151845|NCT01296230|"     The purpose of this study is to determine if the pre-operative levels of sex-hormones can be     used to identify the varicocele patients who can expect improvements in their semen     parameters following varicocelectomy.   "
151846|NCT01296217|"     In this study the investigators want to determine if the detection of lymph node is     applicable in prostatectomy by laparoscopy.   "
151832|NCT01296399|"     Intra-coronary stents deployment reduces the rate of angiographic restenosis as compared to     Balloon angioplasty. in-stent restenosis, usually defined as ≥50 percent diameter stenosis     within previously deployed stent, is most often becoming clinically evident within the first     6 to 12 months after the stent was deployed. Several risk factors are predictors for the     development of in-stent restenosis. These can be generally calcified as either clinical,     angiographic or procedural related factors. However it is difficult to estimate to what     extent In stent re-stenosis is influenced by these various components.      Drug eluting stent, as compared to bare metal stents, markedly reduced the incidence of     angiographic in-stent restenosis. However this benefit must be weighed against a suggested     increased risk of late and very late stent thrombosis, a catastrophic event often leading to     myocardial infarction and death. Often in patients with existing risk factors for in-stent     restenosis, drug eluting stents will be deployed even in cases where patency of a previously     deployed bare metal stent have been demonstrated.      Therefore the researchers sought to investigate whether in patients with previously deployed     bare metal stent and no evidence of in-stent re-stenosis there will be a significant     difference in the rates of in-stent between drug eluting stents and bare metal stents     deployed within de-novo stenotic lesions.   "
151833|NCT01296386|"     An open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84, A     new vaccine against Clostridium Difficile (C. difficile), In healthy subjects   "
151834|NCT01296373|"     RESTORE study:Thailand is a prospective observational study of HIV-1-infected patients who     are either treatment naïve or who have been off anti-retroviral therapy for a ≥12 months, who     have a CD4+ T cell count less than or equal to 350 cells/µL and who have been deemed by their     treating physician that commencement of combination antiretroviral therapy (cART), which is     expected to reduce plasma HIV RNA by ≥1log10 copies/mL, is necessary.      The primary intent of this protocol is to prospectively establish a cohort of patients from     whom clinical data and peripheral blood samples (serum, plasma and peripheral blood     mononuclear cells) can be stored for substudies examining reconstitution of the immune system     and its relationship to disease outcomes.   "
151835|NCT01296360|"     This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years     and 7 months who have been vaccinated with IXIARO in study IC51-323.   "
151836|NCT01296347|"     This study will test the null hypothesis that low-dose ketamine given peri-operatively will     have no effect on the development of chronic post-surgical pain, in patients undergoing     thoracotomy or video assisted thoracic surgery (VATS) procedures      A double-blind, randomised placebo-controlled trial will be used to test the null hypothesis.     Potential participants due to undergo either thoracotomy or video assisted thoracic surgery     (VATS) will be identified by the collaborating thoracic surgeons in the out-patient     department. Patients will be sent information about the study by post, prior to admission for     surgery. If they are willing to participate, written consent will be sought on the ward     preoperatively, where they will complete baseline measures of pain.      Patients will be randomised to receive an intravenous infusion of placebo (saline) or     ketamine running at 0.1mg/kg/hour, starting 10 minutes prior to the surgical incision and     continuing for the first three postoperative days (96 hours in total). Prior to starting the     infusion a loading dose of ketamine (0.1 mg per kg) will be administered.   "
151837|NCT01296334|"     Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain     from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the     present study we investigate primary and secondary hyperalgesia in healthy volunteers     following an experimental first degree burn injury.      The objectives are:        -  to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and          buprenorphine).        -  to investigate if these effects are related to the volunteers individual pain          sensitivity   "
151838|NCT01296321|"     The purpose of this study is to determine whether tailored internet-administrated CBT is a     feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive     symptoms.   "
151839|NCT01296308|"     Despite the long tradition of complementary and alternative medicine (CAM) therapies there     are hardly any interventional trials on type 2 diabetes mellitus. Hence this pilot study aims     to investigate the influence of a two weeks integrative inpatient therapy on the quality of     life in 50 patients suffering from diabetic neuropathy. Integrative treatment includes     aspects of conventional and traditional European and Chinese medicine, mind-body medicine,     physical therapy and lifestyle modification (nutrition advices, stress management and     exercise training). The observational design intends four measurement points: tree months     before (T0), directly before (T1), directly after treatment (T2) and three months follow-up     (T3). The subjective evaluation of the neuropathy-related quality of life was combined with     neurophysiologic instruments (QST), to measure neuropathic symptoms. Also pain intensity,     locus of control, interpretation of illness, coping style, anxiety/depression, life     satisfaction and several biomarkers (HbA1c, ABI, WHR and BMI) are measured. In addition a     qualitative interview should give a view to patient perspective of therapy process.   "
151840|NCT01296295|"     The purpose of this study is to evaluate the effectiveness of regular reporting of     spirometric results combined with smoking cessation advice on smoking quit rate in adult     smokers in primary care.      Hypothesis: In adult smokers, regular reporting of spirometric test results in addition with     smoking cessation advice will increase smoking quit rate.      Expected outcome: increase of smoking cessation rate .   "
151841|NCT01296282|"     To compare two methods of chest impedance: the Medtronics Optivol Measurement via CRT     pacemakers for patients with heart failure and external non-invasive measurement   "
151842|NCT01296269|"     The purpose of this study is to investigate the role of a one-time intranasal administration     of the oxytocin, vasopressin, or placebo on prosocial decision making such as cooperation and     altruism in a healthy population of student controls.   "
151843|NCT01296256|"     The purpose of this study is to determine whether Bendamustine in combination with Etoposide,     Cytarabine and Melphalan (BeEAM) are effective as conditioning followed by ASCT in patients     with aggressive lymphoma.   "
151844|NCT01296243|"     Given the activity of docetaxel in patients with progressive, metastatic castration-resistant     prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an     orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients.   "
151849|NCT01296178|"     Advances in the biological characterization of AML can now make a proper estimate of the risk     of recurrence and likelihood of survival of different groups of patients according to the     expression of different disease parameters. Karyotype, the molecular alterations affecting     genes FLT3, NPM1 and CEBPA, minimal residual disease by flow cytometry and response to first     induction cycle are variables that must be taken into consideration when planning the     treatment of first line from a patient with AML.      This breakthrough in the field of biology has not resulted yet in the development of new     drugs really effective in the treatment of AML. Therefore, the core of the treatment continue     to rely on the use of traditional chemotherapy combined or not with allogeneic hematopoietic     stem cell. Both treatments differ in their antileukemic efficacy, higher in aloTPH, as well     as their toxicity and procedure-related mortality, increased also in the aloTPH. These     aspects should be added that most candidates aloTPH patients lack an HLA identical sibling     donor forcing the search for alternative sources and hematopoietic stem cell donors. These     transplants alternative, but are not committed to their antileukemic efficacy, it does have     implied a greater toxicity. Therefore, the ultimate effectiveness of these procedures depends     largely on the proper selection of candidates for the same.      While there is broad agreement in terms of induction chemotherapy using a combination of     cytarabine with anthracycline, the choice of chemotherapy regimen is controversial     postremisión today. In the poor prognosis of itself involve the LMA, patients classified as     favorable group are acceptable disease-free survival with consolidation schemes involving     high-dose cytarabine. For other patients appear to be inappropriate to combine cytarabine     with an anthracycline, at least one cycle of consolidation, and raise the option of     allogeneic different depending on prognostic markers   "
151850|NCT01296165|"     It is not clear why multi-resistant E. coli (also known as ESBL-producing) have recently     became such important causes of infections in patients living and residing in the community.     A risk factor analysis study performed during 2004 and 2005 in Calgary had shown that the     consumption of the same types of food or well water sources were not significant risk factors     for community-associated infections due to these E. coli. However, a significant and     unexpected risk factor among these Calgary patients was recent visits to certain high-risk     areas such as the Indian subcontinent (India, Pakistan), Africa and the Middle East.     Therefore it is possible that international travel to certain high-risk destinations might     play, in part, a role in the spread of multi-resistant E. coli across different continents.     This would happen via the acquisition of these bacteria in the rectums of returning travelers     and the same organism would later cause an infection. However, the evidence that the spread     and infections due to ESBL-producing E. coli are associated with international travel is     circumstantial at best and the investigators would like to prove that this is indeed true.      The basic idea of the study is to culture the stool of travelers for ESBL-producing E. coli     before they leave for India, within seven days after their return to Canada and again after     six months. The investigators can then establish which travelers are rectally colonized when     visiting India and if these bacteria are still present six months after their return. A     detailed questionnaire regarding the traveler's itinerary and behaviours in India will be     completed on their return to Canada. The investigators will then compare the itinerary and     behaviours of colonized travelers with those of non-colonized travelers and identify certain     high-risk behaviours and places for acquiring ESBL-producing E. coli in India. The     investigators will also determine if colonized travelers will later develop infections with     the same ESBL-producing E. coli they acquired while visiting India.   "
151851|NCT01296152|"     This study was done to look at the level of Depo-Provera, an injectable birth control, in the     blood to see whether it is affected by the anti-HIV drug Kaletra (lopinavir/ritonavir     [LPV/r]). It is not known whether taking Depo-Provera together with Kaletra changes the     amount of Kaletra in blood. Therefore, this study also looked at the levels of HIV and     Kaletra before and after receiving a shot of Depo-Provera. This study evaluated the safety of     Depo-Provera and Kaletra when they are used together. In addition to what is stated above,     this study also explored any effect of Depo-Provera on the immune system.   "
151852|NCT01296139|"     Background:      - Ferumoxytol is an approved iron replacement therapy agent that has some potential for use     as a contrast agent in imaging studies of the lymph system, especially involving lymph nodes     that have been affected by cancer. Ferumoxytol is taken up by normal lymph nodes, but     excluded from cancerous lymph node tissue. Because Ferumoxytol has not yet been approved for     use as an imaging agent, researchers are interested in testing its effectiveness as a     contrast agent for studies of normal lymph tissue and cancer tissue in lymph nodes of     individuals with prostate cancer.      Objectives:      - To evaluate the safety and effectiveness of Ferumoxytol as a contrast agent in individuals     who are scheduled to have prostate removal surgery to treat prostate cancer.      Eligibility:      - Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled     to have surgery to remove the prostate and surrounding lymph nodes.      Design:        -  Participants will be screened with a full medical history and physical examination,          blood and urine tests, and tumor imaging studies.        -  Participants will have a magnetic resonance imaging (MRI) scan to provide baseline          images for the study.        -  Participants will receive an injection of Ferumoxytol and will return for another MRI          scan on the following day (around 24 hours later).        -  Some participants may have a third MRI scan 48 hours after the initial injection of          Ferumoxytol. This third MRI scan is optional and not required by the study.        -  Although the scanning and followup portion of the study will last only a few days,          participants will be considered to be enrolled on the study until after the prostate          removal surgery.   "
151864|NCT01295957|"     The effectiveness of reminiscence for dementia has been claimed as an effective tool, but     scientific validation and systematic assessment of this method is needed. Materials and     Methods: A randomized controlled trial (RCT) was conducted to search whether a reminiscence     program is associated with improvement of quality of life of demented long term care     residents. The trial had three arms: interventional, comparison and control. The reminiscence     program was modeled within a life-story approach, while comparison group received informal     counseling to control for changes in quality of life resulting from social contacts. The     Social Engagement Scale (SES) and Self-rated Quality of Life Index (SRQoL) were the outcome     measures. The results were examined at baseline (T0), twelve weeks (T1), and 6 months (T2)     after intervention. The sample had 135 subjects [intervention group (N=45), comparison group     (N=45) and control group (N=45)].   "
151853|NCT01296126|"     Background:      - Studies have shown that some people develop post-traumatic stress disorder (PTSD) after     being exposed to the trauma of military combat. They may have repeated thoughts, images, and     dreams of the trauma; feel detached from others; have difficulty sleeping and concentrating;     or be easily startled. Some studies have also shown that after having a blow or blast to the     head, some people may develop post-concussive syndrome (PCS), which may include symptoms such     as headaches, difficulty concentrating, and feeling moody or irritable. Researchers are     interested in using magnetic resonance imaging (MRI) to study combat veterans from Operation     Iraqi Freedom or Operation Enduring Freedom in order to evaluate possible changes in the     brain that may be attributed to PTSD or PCS.      Objectives:      - To evaluate changes in brain function in recent combat veterans that may be related to     post-traumatic stress disorder or post-concussive syndrome.      Eligibility:      - Combat veterans of Operation Iraqi Freedom/Operation Enduring Freedom who are enrolled in     Walter Reed Army Medical Center protocol 351030, have returned within the last 6 weeks from a     deployment in Iraq or Afghanistan that lasted at least 3 months, and are able to have     magnetic resonance imaging scans.      Design:        -  This study involves between 1 and 4 outpatient visits to the NIH Clinical Center over          the course of 1 year. The second, third, and fourth visits will occur 3, 6, and 12          months after the first visit.        -  At the first visit, participants will have a baseline MRI scan, followed by a functional          MRI (fMRI) scan to see what parts of the brain are used while performing simple tasks          and responding to images. Participants will complete questionnaires after the scan to          report on their experiences during the MRI scan.        -  For the remaining three study visits, participants will have further MRI and fMRI scans          and will complete additional questionnaires. Participation is complete after the          12-month study visit, or following a diagnosis of PTSD, major depression, or PCS at any          time during the study.        -  No treatment will be provided as part of this protocol.   "
151855|NCT01296100|"     The main aim of this study is to investigate to what extent it is possible to reach normal     glucose metabolism and optimal cardiovascular disease (CVD) risk factor levels with early     lifestyle interventions in people at high risk of type 2 diabetes compared with those who     receive standard therapy (usual care) only.      The project will show the effect of these interventions for the first time in people of low     socio-economic levels living in a Caribbean environment.   "
151856|NCT01296087|"     This study is designed to determine whether TC-6987 improves respiratory function in subjects     with asthma by reducing airway hyper-responsiveness and inflammation.   "
151857|NCT01296074|"     To observe the effect of glucocorticoid on the dynamic changes of monocyte subsets in the     peripheral blood of valve disease patients undergoing cardiopulmonary bypass perioperatively.   "
151858|NCT01296061|"     Primary Hypotheses:        1. Among patients who retain the failed kidney transplant, those who continue          immunosuppressant medication will have more deaths than patients who discontinue these          drugs        2. Among patients who retain the failed kidney transplant, those who continue          immunosuppressant medication will have more hospitalizations for sepsis than patients          who discontinue these drugs        3. Among patients who retain the failed kidney transplant, those who continue          immunosuppressant medication will have fewer rejection events than patients who          discontinue these drugs      Secondary Hypotheses:        1. Patients who undergo elective nephrectomy (to remove the failed kidney transplant) will          have fewer deaths than those who retain the failed kidney transplant        2. Patients who undergo elective nephrectomy (to remove the failed kidney transplant) will          have fewer hospitalizations for sepsis than those who retain the failed kidney          transplant        3. Among patients who retain the failed kidney transplant, those who continue          immunosuppressant medication will have lower levels of allosensitization (anti-HLA          antibodies) than those who discontinue these drugs        4. Patients who undergo elective nephrectomy will have higher levels of allosensitization          (anti-HLA antibodies) than patients who retain the failed kidney transplant   "
151859|NCT01296048|"     The clinical protocol of the clinical testing of this device:        1. Objective of the test: To verify the functions and efficiency of devices.        2. Test methods and procedures: Comparison Test.        3. DUT: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15.        4. Comparison device: Scaleman Body Fat Scales, FS-148BW1 (Predicate Device).        5. Study endpoints: Transtek devices and the predicate device are substantial equivalence.        6. Statistical methodology used: Description of statistical methods.        7. Result: Efficiencies of Transtek devices and predicate device are in the same level.   "
151860|NCT01296035|"     This is a study to find out if the study drug, panitumumab, when given with gemcitabine works     in treating ovarian cancer and to find out what side effects occur when they are given     together.   "
151861|NCT01296022|"     This randomized controlled trial will outline the advantages and disadvantages of the     subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.   "
151862|NCT01296009|"     To investigate the impact of traditional Chinese medicines (TCM) on embryonic implantation in     the patients who have underwent in vitro fertilization and embryo transfer, the investigators     compare the pregnancy rate in traditional Chinese medicine group and control group. The     hypothesis is that pregnancy rate in traditional Chinese medicine group is higher than the     control group.   "
151863|NCT01295970|"     Usually the treatment of a single brain metastasis is surgery or Stereotactic Radiosurgery     (SRS). Surgery involves resection of the brain tumor by means of an operation, whereas SRS is     treatment consisting of highly focused radiation doses to the tumor. These two treatment     modalities are both widely used, well established, and proven to improve survival, but so     far, no study has been done to directly compare the efficacy of one over the other. Neither     treatment in itself is considered to be experimental and both have been shown to provide     benefits to patients with metastatic brain tumors. The aim of this study is to determine     which two modalities are better for local control and improving quality of life.      Patients who consent to this study will be randomized to either receive surgery or     Radiosurgery in the treatment of single brain metastases. The study seeks to recruit 12     patient to each group. Patients will be in this study for up to five years from the time of     the treatment finished. This will include follow-up visits at 4 weeks after the procedure and     then every 3 months after the procedure up to 5 years.   "
151866|NCT01295931|"     Objectives:        1. To determine the feasibility of using microdose amounts of near-infrared (NIR)          fluorescent contrast agent to image tumor-draining and contralateral lymphatics in          melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion          lymph node dissection (axillary or inguinofemoral)        2. To determine the feasibility of using nonradioactive optical imaging techniques with          indocyanine green (ICG) as a fluorescent contrast agent to characterize lymphatic          architecture and function by correlating the observed lymphatic structure and function          with tumor and nodal status as determined from standard-of-care immunohistochemical          evaluation.   "
151870|NCT01295879|"     Vitamin D plays a critical role in maintaining bone health, as well as preventing     cardiovascular disease, cancer, and various autoimmune diseases, such as diabetes. Vitamin D     deficiency is very common in the United States and worldwide, and is now being increasingly     recognized and treated. One group in which vitamin D deficiency may be particularly important     is patients who have had kidney stones. These patients frequently have elevated levels of     calcium in their urine, which is a common and important risk factor for calcium containing     kidney stones. Because vitamin D increases absorption of calcium into the blood by the     intestines, physicians may be reluctant to prescribe vitamin D therapy to patients with     vitamin D deficiency if they also have kidney stones and high amounts of calcium in the     urine. They are concerned about the possible risk of increasing the amount of calcium in the     urine (and thereby increasing the risk of calcium stones occurring again). However, studies     in patients without kidney stones, as well as studies in patients with high calcium levels in     the urine, have demonstrated that giving vitamin D is effective and safe and does not     increase calcium in the urine. Therefore, the investigators will study the effects of giving     vitamin D on the amount of calcium in the urine in patients with a history of kidney stones     and elevated calcium in the urine. The investigators will evaluate the safety of giving     vitamin D to this particular group of patients.   "
151871|NCT01295866|"     Nitric oxide (NO) was considered as a mediator of nasal inflammation and the measurement of     nasal nitric oxide (nNO) may assist in the diagnosis of nasal inflammation. Few data exists     comparing nNO with established, larger accepted reference standard for chronic rhinosinusitis     (CRS) diagnosis. Moreover, the role of atopic status on nNO in nasal inflammatory diseases     has not been reported. The aim of our study was to determine the value of nNO in patients     with chronic nasal inflammation, and to assess the relationship between nNO and atopic status     in these patients. A total of 131 randomized patients suffering form chronic nonallergic     nasal inflammation and 20 healthy volunteers were finally recruited. nNO was measured by NIOX     devices. Sinus computed tomography (CT) scan, nasal endoscope and nasal symptoms evaluation     were used in the different diagnosis of chronic rhinitis (CR), CRS without nasal polyps     (CRSsNP) and CRS with nasal polyps (CRSwNP). Atopic status was confirmed by skin prick test     and serum IgE levels. Blood eosinophils were evaluated simultaneously. Relationships among     nNO, various atopic characteristics and chronic nasal inflammation were evaluated.   "
151872|NCT01295853|"     T3 versus T4 as a primary treatment for palmer hyperhydrosis and effect on postoperative     compensatory hyperhydrosis   "
151873|NCT01295840|"     The purpose of this Clinical Trial is to determine the percentage of patients whose     hemodynamic response improves with the different configurations offered by the new Quartet®     left ventricular lead, as a result of its four electrodes, with respect to the configurations     offered by a standard bipolar lead.      Furthermore, the optimal stimulation configuration will be determined from a comparison with     traditional configurations.   "
151874|NCT01295827|"     This study will be done in 6 parts. In Part A the dose of intravenous (IV) pembrolizumab     (MK-3475) will be escalated to find the maximum tolerated dose (MTD) and recommended Phase 2     dose (RP2D) for participants with a histologically or cytologically confirmed diagnosis of     any type of carcinoma or melanoma (MEL). Part B of the study will explore the safety,     tolerability, and efficacy of the drug in participants with advanced or metastatic MEL and     compare every 2 week to every 3 week dosing. Part C of the study will explore the safety,     tolerability, and efficacy of the drug in participants with non-small cell lung carcinoma     (NSCLC) that is locally advanced or metastatic. Part D of the study will explore the low and     high doses of study drug identified in Parts A and B in participants with advanced or     metastatic MEL. Part E (closed with Amendment 7) will explore low, medium, and high doses of     study drug in combination with standard chemotherapy in participants with locally advanced or     metastatic NSCLC. Part F will explore low and high doses of study drug in treatment-naive and     previously-treated participants with NSCLC with programmed cell death 1 ligand (PD-L1) gene     expression. In Parts D and F and some of Part B participants will be randomized to one dose     level. The primary hypotheses are the following: that pembrolizumab has acceptable safety and     tolerability; and that pembrolizumab shows a clinically meaningful response rate (RR) or     disease-control rate (DCR) in participants with melanoma (ipilimumab-refractory or not), and     a clinically meaningful RR in participants with NSCLC, especially a clinically meaningful RR     in those participants with either cancer, whose tumors express PD-L1.   "
151875|NCT01295814|"     The purpose of this study is to evaluate an investigational treatment for interstitial     cystitis. Interstitial cystitis is a chronic bladder disease that includes the following     symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and     bladder discomfort relieved by voiding.      Presently, there is no cure for interstitial cystitis. The response to current treatments is     poor. Patients with interstitial cystitis have a poorer quality of life. The cause of     interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for     improving the symptoms of patients with interstitial cystitis. Humira® is an injectable     anti-inflammatory medication that has been available for use since December 31, 2002. Humira®     has been FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing     spondylitis, and Crohn's disease. These diseases have similar characteristics to interstitial     cystitis. This study will evaluate an investigational use of Humira® for the treatment of     interstitial cystitis.   "
151876|NCT01295801|"     Linezolid is the first approved synthetic oxazolidinone that is active against     multidrug-resistant Gram-positive pathogens. Because of its significant efficacy, linezolid     is widely used in clinical treatment. However, the side effects of linezolid commonly lead to     anemia and thrombocytopenia. This hematological toxic effects limit its prolonged used. The     investigators have found that Vitamin B6 application, as a preventive, auxiliary therapy, can     relieve anemia and thrombocytopenia. The present study was designed to verify the effects of     Vitamin B6 in the prevention of linezolid-associated cytopenias and investigate its     mechanism.   "
151877|NCT01295788|"     The investigators hypothesize that REAL-Time Continuous Glucose Monitoring (RT-CGM) will be     more effective if introduced in children and adolescents with established diabetes at the     same time as they are starting pump therapy. This randomized controlled trial will compare     the effectiveness of simultaneous vs delayed introduction of RT-CGM in children and     adolescents with type 1 diabetes who are starting insulin pump therapy.   "
151878|NCT01295775|"     The aim of this phase 2 controlled placebo study is to assess the effectiveness of Sulodexide     in the treatment of non proliferative (background) retinopathy in patients with Type 1 and     Type 2 Diabetes Mellitus.      This is a multicentre, double-blind, randomised study involving patients affected by non     proliferative (background) diabetic mild to moderate retinopathy.      This study will involve 130 patients (65 for each group). At baseline visit (T0), the     Investigator will grade the ocular lesions due to diabetic retinopathy according to color     fundus photographs and the fluorescein angiography examination. He will subsequently send the     negatives of photographs and the images -or negatives when available- of fluorescein     angiography to an off-site Assessor -unaware of the Investigator assessment- nominated to     confirm the quality of the images and the grade of the lesions. After positive assessment of     the Investigator, at T0 the eligible patient will be blindly allocated to one of the 2     treatment groups according to a computer-generated randomisation list provided by the     Sponsor.      The following treatments will be administered for 360 days:      A (SULODEXIDE GROUP): 50 mg a day by oral route;      B (PLACEBO GROUP): Sulodexide placebo at the same schedule and for the same lengths of time     as group A.      Before breaking the randomisation code at the end of the study, an independent off site     assessor will evaluate the photographs according to the Airlie House Classification and     following modification by Early treatment Diabetic Retinopathy Study (ETDRS) and fluorescein     angiography according to ETDRS.   "
151879|NCT01295762|"     Apart from brain tumors, Neuroblastoma is the most common solid tumor during childhood. About     50% of the cases present at diagnosis with factors of bad prognosis. During the last two     decades, despite increased therapeutic intensity during induction and consolidation of     high-risk neuroblastomas, the 5 year overall survival of high risk neuroblastoma remains in     between 30 to 40% depending on studies.      Besides strategies of high-dose chemotherapy followed by autologous transplantation of     hematopoietic stem cells, and differentiating molecules (retinoids), immunotherapy will     become one of the leading anti-neuroblastoma targeted therapy. No therapeutic strategies or     molecules obtained such gains of survival ever before.      Studying the immune system of children with neuroblastoma at diagnosis and during their     treatment will help us to determine when we should test active or passive immunotherapy     strategies. Moreover, this study would allow us to specify the cause of tumor immune     tolerance in neuroblastoma, on which we have few data in comparison to adult tumors.      This will be a multicentric, pilot, prospective, open, study that will not require unusual     diagnostic interventions. This study will be transversal (all neuroblastoma stages included)     in order to determine comparative criteria between low and high risk neuroblastoma. It will     also be longitudinal (from diagnosis to post-treatment follow-up) in order to specify     evolutionary aspects of immunity under radio-chemotherapy and retinoic acid therapy.      Immunological analyses will be done on blood, bone marrow and tumor samples, at diagnosis,     and during the treatment of children diagnosed for neuroblastoma (up to 3 time points). These     types of samples are routinely done during conventional neuroblastoma treatment.   "
151880|NCT01295749|"     International recommendations stress on the importance of no flow time reduction in cardiac     arrest management. In fact, no flow time is an independent factor of morbidity and mortality.      In France, cardiac arrests are treated by first responders (including emergency nurses)     before the arrival of a mobile intensive care unit. Those first responders use bag-valve-mask     for ventilation and therefore practice conventional CPR (30 chest compression / 2 ventilation     rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest ventilation. The     purpose of our study is to compare the no flow time between two strategies of out of hospital     cardiac arrest management by first responders: conventional CPR with bag-valve-mask     ventilation vs. compression only CPR with Laryngeal Tube ventilation.   "
151881|NCT01295736|"     Digital ulcers (DUs) are an expression of the microangiopathy in patients with scleroderma     (SSc). DUs lead to pain and impaired hand use. DUs remain a severe complication for many     patients and effective therapy remains elusive. In the present study, the investigators     propose to evaluate the efficacy of Sildenafil in DUs healing in a randomized double blind     control study in SSc patients.   "
151882|NCT01295723|"     The purpose of this research study is to find out the effects (good and bad) of adding a dose     of radiation to the area of the cancer during surgery to whole breast radiation therapy     (WBRT) after surgery. IOERT is the application of electron radiation directly to the residual     tumor or tumor bed during cancer surgery. WBRT is a type of radiation therapy used to treat     patients who have cancer in the breast covering the entire breast tissue. Both immediate and     long-term effects will be measured.      For patients with certain types of breast cancer, one standard treatment is removal of the     area of cancer and a small amount of normal tissue around it followed by breast radiation.     The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks of WBRT followed by     5-8 daily radiation treatments at the site where the lump was removed called a boost.     During this study, the single dose of electron irradiation (IOERT) given at the surgical site     during the operation will replace the usual 5-8 days of localized radiation and the whole     breast radiation will last 3 weeks.   "
151883|NCT01295710|"     The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to     standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe     chronic GVHD-free survival.   "
151884|NCT01295697|"     The goal of this clinical research study is to find the highest tolerable dose of EZN-2208     that can be given to pediatric patients with Relapsed or Refractory Solid Tumors. The safety     of the study drug and its effect on the disease will also be studied.   "
151885|NCT01295684|"     Previous studies have shown that consumption of a low calorie cranberry beverage imparts a     favorable impact on HDL cholesterol, LDL oxidation, and cell adhesion molecules in men.     However, these studies were not well controlled. Thus, it is important to confirm these     effects in a blinded, placebo-controlled feeding study. The investigators goal is to verify     the cardioprotective effects of cranberries by conducting a dietary intervention trial with     healthy subjects in a controlled environment.   "
151886|NCT01295671|"     The overall aim of the study is to compare the effects of three types of beverages -     sugar-sweetened (SSB), artificially sweetened (ASB), and unsweetened (USB) - on     cardiovascular disease (CVD) risk factors and body weight among young adults.   "
153584|NCT01273493|"     The purpose of this study is to characterize the pharmacokinetics (blood levels) of     trabectedin after administration to patients with advanced malignancies and hepatic (liver)     dysfunction.   "
151887|NCT01295658|"     The Cancer Support Community's (CSC) Research and Training Institute has created the Cancer     Experience Registry: An Online Initiative to Change the Future of Cancer Care to identify and     understand the emotional and social needs of cancer survivors. Armed with this knowledge, the     investigators will raise awareness about and help develop programs to address the needs of     cancer survivors. Anyone who has ever received a cancer diagnosis, whether recently     diagnosed, in treatment, or years post-treatment can participate. Interested cancer survivors     can register at www.cancerexperienceregistry.org   "
151888|NCT01295645|"     The goal of this clinical research study is to learn if adding cidofovir to the standard of     care can improve symptoms of hemorrhagic cystitis caused by the BK virus as compared to     standard of care alone. The safety of cidofovir will also be studied.   "
151935|NCT01295034|"     The ability of vitamin D to modulate the immune system and strengthen bones may mitigate the     adverse medication consequences of HIV/AIDS, but little is known about either the health     benefits of vitamin D supplements, or about the optimal dosing regimen for patients on highly     active antiretroviral therapy (HAART). This trial is a comparison of two regimens for     administering vitamin D and calcium to HIV-positive individuals taking antiviral medications.     This study will help physicians make evidence-based decisions about the most effective way to     use vitamin D in their patients and enable the design of large multi-center trials in the     future.   "
151889|NCT01295632|"     This is a two part study of the drug MK-8669 (ridaforolimus) given with MK-2206 or MK-0752.     In Part A of the study, the preliminary maximum tolerated dose (MTD) of the drug combinations     will be found by giving sequentially higher doses of the study drugs. An expansion cohort of     participants may be enrolled to confirm the MTD. New cohorts at other dose levels may be     enrolled, depending on the rate of dose limiting toxicities (DLTs) in the planned cohorts. In     Part B, an assessment of the efficacy of the drug combinations against selected advanced     cancers will be made so that a recommended dose to be used in Phase 2 studies (RPTD) can be     found. As of 19 July 2012 the MK-0752 arms of the study were fully enrolled and closed to     further recruitment. As of 30 November 2012, no additional participants with prostate cancer     will be enrolled.   "
151890|NCT01295619|"     This is a prospective study to evaluate the performance and safety of a new medical device     used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.   "
151891|NCT01295606|"     To document cefazolin disposition (concentration/time profile, protein binding, metabolism,     renal elimination characteristics) and its covariates in neonates following intravenous     administration of the drug at induction of anesthesia, prior to an invasive procedure      To evaluate if optimalisation of cefazolin dose regimen during neonatal life is needed   "
151892|NCT01295593|"     Rationale New chemotherapeutic agents are needed in relapsing B-Cell Chronic Lymphocytic     Leukemia (B-CLL) to overcome resistance of CLL cells. Valproic acid (VPA) is an inhibitor of     histone deacetylase (HDAC) used as an anticonvulsant and mood-stabilizing drug for decades.     VPA mediates apoptosis in CLL cells through caspase activation. VPA shows toxicity toward CLL     cells displaying alterations in the p53 pathway. The combination of VPA with fludarabine or     2-Chlorodeoxyadenosine (CdA, Cladribine) results in synergistic loss of B-CLL cell viability,     and significant increase in apoptosis. The highest index of synergism is observed between VPA     and CdA, a purine nucleoside analog active in B-CLL.      Study design Overall, the study will be proposed to previously treated patients with advanced     B-CLL, who are not eligible for aggressive approaches, and who exhibit progressive disease. A     total of 33 patients will be included. Estimated enrolment time is 2 years.        -  First part: It is planned to start therapy with single VPA during 2 months, targeting          plasma levels that have been reported to be active in vitro toward CLL cells (but that          do not exceed therapeutic levels in seizure prevention), and in parallel, to verify          whether cellular targets of VPA have been actually inhibited in leukemic B-lymphocytes.        -  Second part: After the VPA preloading period (2 months), patients will be evaluated to          receive CdA. CdA will be given at 5.6 mg/m²/day intravenously during 3 days, a          reduced-dose schedule which is less toxic - at no obvious cost of loss of efficacy - as          compared to the standard dosage of 5 days. CdA was chosen because it displays the          highest level of in vitro synergism with VPA. Four monthly courses of CdA will be given.          Patients will then be evaluated. VPA will be stopped at the time of response evaluation          (scheduled 28 days after the last course of CdA).   "
151893|NCT01295580|"     The purpose of this study is to determine the comparative safety and efficacy of knee     intra-articular injection of hyaluronic acid obtained from two different sources in the     treatment of knee osteoarthritis.   "
151894|NCT01295567|"     Rationale:      Due to western lifestyle human coronary arteries are prone to develop atherosclerotic     plaques. Hence the heart is an important target organ for atherothrombotic complications:     myocardial ischemia, arrhythmias, myocardial infarction and heart failure. To alleviate     symptoms and decrease mortality in these patients, myocardial revascularisation is     recommended. Coronary artery bypass grafting (CABG) is indicated in patients with severe     atherosclerotic disease of all three coronary arteries or the left main stem coronary artery.     Cardiac ischemia and reperfusion injury during CABG is inevitable and jointly accountable for     complications that occur after CABG (e.g. death, myocardial infarction, arrhythmias, stroke,     or renal complications). Dipyridamole has been shown to reduce ischemia reperfusion injury in     healthy volunteers using an intermediate endpoint and may prevent cardiovascular death or     event in secondary prevention after cerebrovascular disease. The investigators hypothesise     that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against     ischemia and reperfusion injury due to CABG. The investigators expect lower troponin-I     release in patients who were pretreated with dipyridamole.      Objective: To study the effect of oral pretreatment with dipyridamole on high sensitivity     (HS)-troponin-I release after CABG. Secondary objectives are whether oral pretreatment with     dipyridamole reduces postoperative CABG arrhythmias, prolonged inotropic support, and     duration of Intensive Care-stay. Further secondary endpoints are the effects of dipyridamole     pretreatment on renal injury and post-ischemic recovery of contractile function (measured     ex-vivo).      Hypothesis:      The investigators hypothesize that oral pre-treatment with dipyridamole can increase cardiac     tissue tolerance against ischemia and reperfusion injury. The investigators expect lower     HS-troponin-I release in patients who were pretreated with dipyridamole. Additionally the     investigators expect the incidence of arrhythmias, need for prolonged inotropic support     (longer than 24 hours postoperative) to be decreased in pretreated patients.   "
151895|NCT01295554|"     Magnetic Resonance Angiography (MRA) of the peripheral arteries has become essential in the     diagnosis and follow-up of peripheral arterial disease.      In clinical routine, the acquisition uses intravenous injection of a Gadolinium based     contrast agent (gadolinium chelates).      Initially, contrast enhanced MR angiography (CE-MRA) was recommended for diabetic patients,     elderly patients and\or patients with chronic renal insufficiency presenting a     contraindication to CT angiography using iodized contrast agent injection.      However, the increase in nephrogenic systematic fibrosis clinical cases, which would be     secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has     restricted the use of CE-MRA. More than 500 cases were described to date in the world.      Its occurrence is currently estimated around 4 % for patients in terminal chronic renal     insufficiency and its mortality around 30 %.      According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast agents     (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate Dimeglumine-MAGNEVIST     *, Bayer HealthCare) are contraindicated if the glomerular filtration rate is lower than 30     ml/mn.      Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide     complete and non-invasive investigation of the peripheral vasculature, from the abdominal     aorta to the calf, thus offering patients with chronic renal insufficiency a surrogate with     no side effects.      Moreover, the use of high field (3T) MR imaging and phased array coils offers high quality     images and good signal to noise ratio for peripheral vasculature analysis.      Besides, the acquisition can be repeated if required as it does not require any contrast     injection.      The main objective is to evaluate the quality of the NCE images obtained for every     investigated station from the abdominal aorta to the calf.      The secondary objective is to compare the diagnostic performances of NCE images with those of     CE MRA.      The third objective is to estimate the contribution of automated and dedicated     post-processing tools in optimizing the diagnostic quality of the images.   "
151896|NCT01295541|"     The current study is proposed to assess the frequency and type of progressive mobility     procedures currently performed in the CVICU The study will evaluate the type and frequency of     progressive mobility orders, whether or not progressive mobility steps are being taken by the     nursing teams, define what steps patients are receiving, and record time to first weight     bearing. Other outcome measures will be the days of required mechanical ventilation, and     current ICU length of stay and cost to treat.   "
160759|NCT00000196|"     The purpose of this study is to determine the effect of acute naltrexone pretreatment on the     response to yohimbine in healthy volunteers.   "
151897|NCT01295528|"     The clinical protocol of the clinical testing of this device:        1. Objective of the test: To verify the function of device.        2. Test methods and procedures: Performance test in two positions: Seated and Supine.        3. DUT: Transtek Blood Pressure Monitor, Model: TMB-986. Cuff size: 22-32cm and 22-42cm.        4. Comparison device: Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg.        5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.        6. Statistical methodology used: Description of statistical methods.        7. Result: Meet the requirements of SP10.   "
151936|NCT01295021|"     The purpose of this NIS is to assess the prevalence of sympathetic overactivity in patients     with newly diagnosed essential hypertension.   "
187134|NCT00294957|"     Assessing the psychological and physiological status of Israeli former prisoners of war     (POW).   "
151898|NCT01295515|"     Background:        -  Antiretroviral therapy (ART) has been able to improve the lifespan of individuals          infected with human immunodeficiency virus type 1 (HIV-1), but ART requires continuous          treatment that has substantial consequences on quality of life. ART suppresses HIV-1          virus levels below the limits of detection in current tests, but does not completely          eradicate the virus from the blood. Recent research is attempting to determine whether          this persistent infection stems from a low-level infection where new cells are          continually infected with HIV, or from cells that live for a long time after infection.          ART is very active against the virus in new cells, but has no effect on long-lived cells          that are already infected with HIV-1 at the start of ART. As a result, new strategies          may be necessary to reduce or eradicate these 'reservoir' cells.        -  Interferon is a natural substance made by the body to combat virus infections, but can          also be made as an injectable drug known as PEGINTRON. PEGINTRON injections have been          approved to treat hepatitis C infection, including in patients with HIV infection.          Earlier studies of HIV-infected individuals who were not on any ART showed that          interferon reduced the level of HIV in the blood. Researchers are interested in          determining whether PEGINTRON therapy will also reduce the residual low levels of HIV in          patients who are already taking ART.      Objectives:      - To evaluate the effectiveness of PEGINTRON injections on HIV levels in participants     currently undergoing antiretroviral therapy.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with HIV, are currently     undergoing antiretroviral therapy, and have maintained HIV virus blood counts that are not     detectable by current commercial tests for at least 12 months before the start of the study.      Design:        -  This study will involve separate screening and treatment processes.        -  Participants will be screened with a physical examination and medical history, including          blood and urine samples. The screening analysis to determine study eligibility will take          several weeks. Participants will have apheresis to provide sufficient numbers of blood          cells for evaluation by the study researchers.        -  Eligible participants will begin a 4-week course of PEGINTRON injections using the          standard dose of PEGINTRON that is approved for treatment of chronic hepatitis C.          Participants will have weekly injections and have frequent blood tests to measure HIV          virus levels.        -  Participants who experience problems in maintaining safe numbers of white blood cells          during the study may receive injections of filgrastim to increase their white blood cell          count.        -  After the 4 weeks of treatment, participants will return for additional blood tests on          study days 28, 35, 42, 49, 56, and 84, and Weeks 16, 24, 36, and 48 (i.e., through the          end of 1 year after the start of the study).   "
151899|NCT01295502|"     This phase I trial studies the side effects and the best dose of paclitaxel and carboplatin     after cisplatin and radiation therapy in treating patients with stage IB-IVA cervical cancer.     Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to     kill tumor cells. Giving paclitaxel and carboplatin after cisplatin and radiation therapy may     kill more tumor cells.   "
151900|NCT01295489|"     This research trial studies biomarkers in patients with previously untreated invasive ovarian     epithelial, fallopian tube, or primary peritoneal cancer. Studying samples of tumor tissue,     peritoneal cavity fluid, and blood from patients receiving chemotherapy directly into the     abdominal cavity (intraperitoneal) may help doctors learn more about the effects of     intraperitoneal chemotherapy on cells. It may also help doctors identify and learn more about     biomarkers related to cancer.   "
151901|NCT01295476|"     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is studying biomarkers in bone marrow samples from patients with     T-cell acute lymphoblastic leukemia.   "
151902|NCT01295463|"     RATIONALE: Learning about the amount of information on fertility and infertility by patients     before they received treatment for cancer in a comprehensive cancer center may help doctors     plan the best treatment.      PURPOSE: This clinical trial is studying the amount of information on fertility and     infertility received by patients before treatment of cancer in patients who have finished     treatment.   "
151903|NCT01295450|"     The purpose of this study is to evaluate the efficacy and tolerability of Apevinat BC     compared to vitamin complex, in the treatment of lack of appetite and prevention of     deficiency of B and C vitamins.   "
151904|NCT01295437|"     Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of     this study was to compare long-term results of hernioplasty using three different meshes     (partly absorbable, lightweight polypropylene and thick polypropylene mesh).   "
151905|NCT01295424|"     Observational study of all out-of-hospital cardiac arrest during 6 months in regional areas     of Helsinki University Hospital and Kuopio University Hospital from activation of EMS system     until follow up to 6 months of survival.Simultaneous observation of out-of-hospital cardiac     arrest primary survivors admitted to all Finnish ICUs.   "
151906|NCT01295411|"     The aim of the investigators analysis is to identify the neural correlates of quality of life     scores in schizophrenia. For this, the investigators will constitute group of patients     according to their quality of life scores and the investigators will analyze their     differences in patterns of brain structures and activations.   "
151907|NCT01295398|"     The aim of the investigators study is to compare in children aged less than 18 months and     hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile     ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm),     or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a     mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).   "
151908|NCT01295385|"     Diagnosis of diabetic cardiomyopathy is then retained, supposing a change in the coronary     microcirculation linked to an endothelial dysfunction. Abnormalities of the myocardial     metabolism is frequently associated. It is regrettably about a hypothesis difficult to verify     with current medical techniques.This deficiency being not only harmful to the diagnosis, but     also to the assessment of the efficiency of the medical treatment on the myocardial     metabolism and the endothelial function. Techniques of nuclear magnetic resonance offer     interesting perspectives.   "
151909|NCT01295372|"     To assess the effect of zicronapine versus risperidone on metabolic parameters comprising     body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and     glucose during 6 months of treatment.   "
152015|NCT01293994|"     The investigators will be collecting saliva DNA samples from chronic back pain patients. The     investigators hope to find candidate genes associated with response to opioid medication by     correlating molecular genetics data with pain measurement and opioid responsiveness data     including opioid hyperalgesia and opioid analgesic tolerance.   "
151937|NCT01295008|"     The purpose of this study is to assess whether patients with the classic form of Fabry     disease have significantly less androgenic alopecia (male pattern baldness).   "
151948|NCT01294865|"     The purpose of the study is to investigate the plasma levels of Soluble Urokinase Plasminogen     Activator Receptor (suPAR) at the diagnosis and after treatment of sepsis, and to determine     whether it has a diagnostic and prognostic value in late-onset neonatal sepsis.   "
151910|NCT01295359|"     The Chronic Obstructive Pulmonary Disease is a leading global cause of morbidity and     mortality, so it's important to find actions that could improve quality of life and decrease     the mortality. The objective of this study is to verify if a ground walking program applied     to hospitalized exacerbated COPD patients has effects in quality of life, exercise capacity,     airways obstruction, body composition, heart rate variability, quadriceps isometric force and     in the Body-mass index, Airway Obstruction, Dyspnea, Exercise Capacity index (BODE index).     An evaluators-blinded randomized controlled study will be conducted in Hospital Escola     Municipal de São Carlos where forty patients will be recruited to participate. The     volunteers will be randomized in two groups with twenty patients, the usual care group, that     will receive only the usual care of the hospital; and the trained group that will receive the     same care, but will also participate in a ground walking program associated with respiratory     exercises. It will be evaluated, in the start and at the end of the program, the health     related and general quality of life and the Barthel index. Daily, the patient will be     submitted to the Six Minute Walk Test, to a body composition analysis, to a hand grip test     and to a dyspnea assessment, and will be calculated its BODE index. All patients will be     invited to a follow up in the 12th and 24th weeks after hospital discharge, when they would     receive the same evaluation of the last day in the hospital. All the collected data will be     expressed in means and standard deviations or medians and range when appropriated. It will be     chosen appropriated tests to compare and correlate them.   "
151911|NCT01295346|"     The purpose of this study is to assess if putative brain injury biomarkers have utility as     blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be     accomplished by examining the relationships between potential serum-based TBI biomarkers and     clinical measures of injury severity, occurrence of complications, and outcome, in subjects     with mild or moderate TBI. The assay will be evaluated in a sample population of subjects     over the age of 18 who have been referred to the health care provider for closed head injury     evaluation.   "
151912|NCT01295333|"     The aim of our study is to compare in a randomized multicentric study the early prophylactic     introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation (experimental arm)     compared to a conventional approach based on the initiation of LT4 as soon as the first     biological signs of hypothyroidism. Two hundred patients with Graves' disease with no or     minimal (eyelid retraction or oculopalpebral asynergy) and non inflammatory ophthalmopathy     (clinical activity score to 0) will be included in this study. The administrated iodine-131     activity will be adjusted to the weight of the thyroid gland (20 MBq/g thyroid tissue).     Patients will be evaluated at 6 weeks, 3 months, 6 months and 12 months post-ablation. The     primary objective will assess differences in terms of quality of life at 3 months using a     specific questionnaire (ThyPRO). Secondary objectives will compare quality of life outcomes     at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck),     autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy     and medico-economic data.   "
151913|NCT01295320|"     The subjects included in this study are subjects that participated in study NCT00434577.     These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and     Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for     safety and immunogenicity.      This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and     safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.      The study visits will be scheduled at approximately one year intervals after the first visit     in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be     taken from all subjects at each visit. Information on safety and the occurrence of HZ will     also be collected during these visits.   "
151914|NCT01295307|"     In relapsed or refractory AML allogeneic HCT is considered to be the only treatment by which     long-term disease-free survival can be achieved. Despite this favorable prospect, even in     younger patients with relapsed AML only about 40% of the patients reach allogeneic HCT. A     number of factors contribute to this low rate of transplantation, among them moderate     activity of the salvage regimens and accumulating toxicities which prevent from     transplantation; Prospective clinical trials in this indication usually focus either on the     rate of CR achieved after a defined number of cycles of salvage therapy or on transplantation     modalities. The consequent integration of salvage therapy into a transplant strategy     accounting for the time-dependent process of donor search has not been studied so far.      The objective of this study is to evaluate the safety and efficacy of clofarabine salvage     therapy prior to allogeneic HCT.   "
151915|NCT01295294|"     The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic     acid) can control irregular bleeding during the first 3 months of using Mirena. The study     drugs tested are tested against placebo (dummy medication not containing any active drug).     Treatment period is followed by a one-month period when study drugs are not taken but Mirena     use is continued.   "
151916|NCT01295281|"     The hypothesis to be investigated is if the tolerability of intermittent catheterization with     Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e.     clinically non-inferior when using POBE 2.0 compared to PVC.      Secondary objectives are to evaluate the safety and the subject's perception associated with     the use of the catheters, assessed by the recording of adverse events and the ease of     handling by means of a subjective assessment scale.   "
151917|NCT01295268|"     The goal of this study is to determine if vulvar (external female genitalia) pain is     decreased with emu oil over a similar placebo oil (no active ingredient) by using measurement     devices, examinations, and questionnaires. Topical emu oil has not been scientifically     studied for this condition yet, but related reports show no significant side effects or     potential benefits.      A total of 30 women will participate in the study at William Beaumont Hospital, Royal Oak.   "
151918|NCT01295255|"     Allergic rhinitis (AR) and asthma are considered as one airway, one disease. Although there     is increasing evidence for an association between allergy and depression, it remains unknown     if the relationship between AR and asthma has extra influence on the psychological status of     the patients. The aim of our study was to investigate the influence pattern of asthma on the     psychological status in AR patients. The Symptom Checklist-90 (SCL-90) was employed to     analyze the psychological status of 524 individuals with AR. Independent sample T-tests,     one-way ANOVA and multivariate ANOVA were used for data analyses.   "
151920|NCT01295229|"     The escalating pandemics of obesity and type 2 diabetes mellitus (T2DM) are among the most     significant contributors to morbidity and mortality worldwide. Roux-en-Y gastric bypass     (RYGB) surgery causes profound weight loss and dramatically ameliorates T2DM through     mechanisms beyond just weight loss, but its role in diabetes management and the nature of its     weight-independent anti-diabetes effects are not well established because of a paucity of     appropriate randomized trials, the execution of which is hindered by numerous obstacles. The     investigators therefore propose a feasibility study to demonstrate our capacity to identify,     recruit, randomize, and track outcomes for 40 adult Group Health members identified as having     T2DM and a BMI between 30-40 kg/m2.   "
151921|NCT01295216|"     Nearly half of the adult population in Latin American urban settings has abnormally high     blood pressure. Although half of these subjects with high blood pressure are still in the     pre-hypertensive stage (systolic blood pressure values in the 120-139 mmHg range or diastolic     blood pressure in the 80-89 mmHg range), the rate of progression to hypertension is high     (10-20% per year), according to studies done in other settings. The main objective of this     proposal is to evaluate the effectiveness of an affordable and sustainable primary health     care intervention to reduce blood pressure and prevent progression from pre-hypertensive     status to hypertension in individuals at poor urban clinics in Argentina, Guatemala, and     Peru. Our primary hypotheses are that pre-hypertensive subjects who receive mHealth (mobile     health) support for 12 months (intervention group) will have lower blood pressure compared to     individuals who receive the usual primary health care (control group); and that     pre-hypertensive subjects will maintain lower blood pressure six months after receiving     mHealth support. The investigators will determine the effects of an intervention using     mHealth technology, including short message services (SMS) and one-to-one telephone calls, to     promote lifestyle modification focused on reducing blood pressure among participants. The     intervention also aims to help participants become better informed, motivated, and encouraged     to practice self-management of their own health; to improve patient satisfaction levels;     provide tailored targeted interventions; and to improve patient-provider relationships. The     proposal is designed as a proof-of-concept intervention in three Latin American countries     that encompass a wide range of environments and health care settings. A total of 212 subjects     (30-60 years old) per country will be recruited in primary health clinics and randomized to     study groups. Blood pressure, anthropometry, and behavioral risk factors (physical activity,     diet, stress, alcohol and tobacco use) will be measured at baseline and at months 6 and 12     during the intervention, and six months after the end of the intervention. The investigators     will also evaluate feasibility, acceptability, cost-effectiveness, and process implementation     of the intervention.   "
151922|NCT01295203|"     The purpose of this study is to determine whether access to a website with personalized     feedback on physical activity level and suggestions to increase physical activity results in     improvements in self-reported physical activity, anthropometrics and physiological     measurements   "
151923|NCT01295190|"     Propofol has been routinely used for general anesthesia during pediatric cardiopulmonary     bypass at our institution without complications. However, propofol may cause propofol     infusion syndrome (PRIS), a rare, but often fatal complication mainly defined by bradycardia     with progress to asystolia. Metabolic acidosis is regarded as an early warning sign of PRIS.     Due to the preconditioning effects of sevoflurane and its availability for cardiopulmonary     bypass, propofol has recently been substituted by sevoflurane during pediatric     cardiopulmonary bypass at our institution. In this study the effect of substituting propofol     by sevoflurane on metabolic acidosis and outcome are examined.   "
151924|NCT01295177|"     The purpose of this study is to determine whether topic insulin is effective to accelerates     wound healing in diabetes patients   "
151925|NCT01295164|"     The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual     simulator (AOVIS-I). The system provides an objective characterization of the optical quality     of the patient's eye by application of wave-front sensing technology. The optical condition     of every eye is represented by its wave aberration. This characterization overcomes the     current description based only in refractive errors. This provides an accurate description of     the optics of the eye based on the assessment of the whole set of ocular aberrations. The     particular wave-front sensor is of a Hartmann-Shack type. One characteristics of this     wave-front sensor is its high dynamic range allowing measuring highly aberrated eyes, such as     patients with keratoconus.   "
151926|NCT01295151|"     The principal aim of this study is to fill a clear knowledge gap and provide guidance for     rheumatologists and reassurance to the patient group on a management challenge faced daily in     rheumatology practice. Specifically, it aims to provide robust evidence on the optimal     management of patients with established RA that have failed an anti-TNF therapy (the first of     the biological therapies to be introduced); in particular, the investigators wish to address     whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or     abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is     to broaden treatment options and target these specific therapies to disease sub-groups.   "
151927|NCT01295138|"     Constipation following elective Caesarean sections (CS) is a common problem experienced by up     to 50% of patients (1). The causes for this are multifactorial and include manipulation of     the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic     techniques. To try to alleviate the problem of postoperative constipation, some anaesthetists     prescribe postoperative lactulose in addition to postoperative analgesia, although no data     exists that shows whether this has any beneficial effect on postoperative constipation.      1. Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4): 190-4).   "
151928|NCT01295125|"     The purpose of this study is to compare open abdominal incisional hernia repair using     XenMATRIX biologic mesh versus repair with their own tissue. This study will provide     information in determining if a biological mesh is necessary to provide a sturdy repair for a     ventral hernia.   "
151929|NCT01295112|"     This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®)     eye injections reduces the need for repeat bevacizumab eye injections in patients with     nonischemic central retina vein occlusion.   "
151930|NCT01295099|"     To clarify the mechanisms of Keloid scar formation.      Elucidate the action and therapeutic value of 5-FU in Keloid scar treatment      Identify the genetic link with Keloid scar formation.      Quantify the psychological/social impact in keloid scarring patients   "
151931|NCT01295086|"     The primary aim of this dose-finding study is to determine the maximum tolerated dose of     taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third     week as first-line treatment in patients with HER2-positive advanced gastro-esophageal     cancer. Secondary end points are to evaluate progression-free survival and overall survival.   "
151932|NCT01295073|"     The primary purpose of the protocol is to evaluate whether Trientine Hydrochloride, a copper     chelator which is an agent that binds with and removes copper, will be effective in     minimizing macular edema after cataract surgery in individuals with type 2 diabetes. It is     our hypothesis that there will be a reduction in copper-attributed inflammation after surgery     resulting a decrease in edema.   "
151938|NCT01294995|"     Human studies of Chinese liquor are sparse. The investigators hypothesize that short-term     Chinese Tea-flavor liquor (TFL) consumption may be beneficial to inflammation biomarkers and     CVD risk factors. Guizhou Meijiao Liquor (GML) is a traditional Chinese liquor, fermented     from sorghum, corn, sticky rice, wheat and rice, while TFL is a novel Chinese liquor     fermented from above 5 grains plus green tea.      Forty-five volunteers(23 males, 22 females) were selected to participate a paralleled     randomized trial drinking 30 mL two kinds of Chinese liquors: TFL and GML respectively with     meal every day for 28 days. Serums of volunteers were collected for analyzing serum lipids,     inflammation biomarkers and CVD risk factors.      TFL could significantly decrease systolic blood pressure of males, but increase diastolic     blood pressure of females. TFL could also decreased blood lipid of volunteers, especially for     females. Both liquor significantly decrease serum uric acid and glucose in males and females.     The effect of the two liquors on inflammation biomarkers were complicated and needs further     research work.      TFL may possess more beneficial effect on CVD risk factors than GML probably because of the     special fermentation products of green tea with other grains.   "
151939|NCT01294982|"     The purpose of this study is to evaluate the safety, tolerability, and effectiveness of the     study product, AOBO-001, when taken by adults with symptoms of overactive bladder. AOBO-001,     is experimental, which means that the U. S. Food and Drug Administration (FDA) has not yet     approved it for use. AOBO-001 has been approved in China as a prescription drug product to     treat bedwetting in children. AOBO-001 is also approved in Hong Kong as a dietary supplement     to improve quality of life for people with urinary incontinence. AOBO-001 is a botanical     (from a plant) product. It is prepared from the seeds of Xanthoceras sorbifolia bunge plant,     which is a flowering tree grown in Northern China. Approximately 60 subjects who are 18 years     of age and older are expected to participate in this study at up to 8 investigational sites.     Each subject will complete 6 visits to the study site over a 14-week period. Subjects will     consume 8 capsules of the assigned test product twice daily (that is, 16 capsules daily).     Capsules will be taken with at least 6 ounces of water approximately 30 minutes before     breakfast and 30 minutes before dinner. If a subject qualifies, he/she will be randomly (by     chance) assigned to one of three study treatment groups. Subjects in one group will consume     capsules containing a daily dose of 3.2 grams of AOBO-001; a second group will consume     capsules containing a daily dose of 6.4 grams of AOBO-001; and a third group will consume     capsules containing a placebo (no active ingredients). Subjects will have a 2 in 3 chance of     being assigned to an active study treatment group. Neither the subject nor the study doctor     will know to which study treatment group the subject has been assigned, but this information     is available in case of a medical emergency. There will be a time during the study dosing     schedule when all subjects will consume capsules containing a placebo (no active     ingredients). Subjects will not be told when they are receiving the placebo.   "
151940|NCT01294969|"     To evaluate patient perceptions of Al-4943 in subjects with allergic conjunctivitis     previously treated with a topical ocular anti-allergy leukotriene-release inhibitor     medication.   "
151941|NCT01294956|"     The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign     of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.   "
151942|NCT01294943|"     The concern with oral infection and its systemic repercussions is old, many studies have been     undertaken to establish this relationship more precisely. One of the areas mouth still little     studied in this regard is the colonization of language within this universe of the oral     microbiota colonization and how this may affect the general state of health care-dependent     individuals.      This research aims to evaluate the efficiency of a tongue cleaning device and its potential     impacts on infectious patients fully or partially dependent care hospital.      Patients admitted to intensive care units and inpatient units will be evaluated, divided into     two groups: Study Group (SG) - Patients who receive oral hygiene using the tongue cleaning     device, and Control Group (CG) - Patients who are cared for according to the routine of     hospital nursing.   "
151943|NCT01294930|"     Patients operated for hip fractures are older and have several conditions that have negative     influences on the perioperative and postoperative prognosis.      Hip fractures can also be painful, which is stressful for the physiology of the patient. Many     old patients have received to little fluid intake. They often have diuretic therapy, which     even worsens dehydration/hypovolemia.      Some patients have to wait several days for surgery. Several studies have shown a high degree     of complications and an increased mortality in this patient group.      Early preoperative optimization can improve the outcome. The available methods for     optimization of the patient are complicated and time consuming.      The investigators wish with this study to try new approaches to find which patients still are     dehydrated when they come to the operation ward.      The aim is to measure the color and density of the urine as well as to register the the     variability in the plethysmographic curve before spinal anaesthesia.      These results will be compared to circulatory instability during and after surgery as well as     to postoperative complications.   "
151944|NCT01294917|"     Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue     Oasys lenses.   "
151945|NCT01294904|"     Patients with chronic kidney disease (both men and women), especially those with terminal     renal failure, manifest infertility. There has been demonstrated several hormonal changes in     patients on dialysis. Increased levels of luteinizing hormone (LH) has been seen in men (12).     In women the opposite has been reported. The number of spermatocytes is reduced and a     disturbance in maturation has been observed.      This project is aimed to study the influence of uremic milieu on fertility in men and women.     The hypopituitary/hypothalamus gland axis and hormonal levels will be studied.   "
151962|NCT01294683|"     This study is being done to find out if tablets containing extended release (ER) niacin,     laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin     and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol     and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g/40 mg is     equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing low-density     lipoprotein cholesterol (LDL-C).   "
151946|NCT01294891|"     The purpose of this study is to examine how abnormal blood flow in the small vessels     (microvessels) of the heart, muscle and kidney in paroxysmal nocturnal hemoglobinuria (PNH)     or sickle cell disease leads to poor functioning of the heart and kidney. To test this     question, the investigators will perform imaging tests (contrast ultrasound perfusion     imaging) to look at the flow and function of these microvessels and compare this information     to heart and kidney function. To further look at this question, patients who have PNH will be     studied before and after starting a new drug (Soliris) that decreases damage to blood cells.     In patients with sickle cell disease, patients will be studied at baseline (not during a pain     crisis) and also during a pain crisis if one develops.   "
151947|NCT01294878|"     By hypothesising that Interstitial Cystitis is an allergic disorder of the urogenital system     that is linked to mast-cells, current therapy with omalizumab may represent a potential non     symptomatic strategy for the treatment of IC/BPS   "
151949|NCT01294852|"     The purpose of this study is to determine whether the immediate bolus strategy combined with     early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation     compared to the administration of surfactant prophylaxis at 15 minutes after birth with early     nCPAP in premature infants.   "
151950|NCT01294839|"     This is a prospective, randomized, double blinded, multi-center, controlled study to evaluate     the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and     RVA) and the different conduction path (RVOTs and AV node) on cardiac dysfunction prevention.   "
151951|NCT01294826|"     The study will determine the maximum tolerated dose (MTD) of AUY922 given in combination with     cetuximab in previously treated patients with KRAS wild-type metastatic colorectal cancer.   "
151952|NCT01294813|"     Electrical Impedance Tomography (EIT)is a technique based on the injection of small currents     and voltage measurements using electrodes on the skin surface generating cross-sectional     images representing impedance change in a slice of the thorax. It is a radiation free,     non-invasive and portable lung imaging technique. Impedance changes in lung ventilation are     investigated in mechanically ventilated patients who routinely undergo bronchoscopy in     intensive care medicine. Bronchoscopy is performed to suction secretions as well as to     analyze the secretions to recognize inflammations and diseases. It is an essential     intervention which causes changes in ventilation which remain for 1-2 hours. It is not     completely investigated why these changes in ventilation remain for so long time and how they     are distributed regionally. Therefore the purpose of this study is to investigate the change     in pulmonary regional ventilation in patients who routinely undergo bronchoscopy to possibly     generate ideas how to optimize the ventilation after bronchoscopy to optimize the patient´s     treatment.   "
151953|NCT01294800|"     This study is to evaluate the efficacy of a range of preladenant doses compared with placebo     in participants with moderate to severe Parkinson's disease (PD) experiencing motor     fluctuations and receiving a stable dose of levodopa (L-dopa), as measured by off time.     Participants will continue to receive their stable regimen of L-dopa plus any adjunct     medications during the study as prescribed by their physician. Several classes of adjunct     medications may be used, including Amantadine, anticholinergics, dopa decarboxylase     inhibitors, and dopamine agonists.      Primary Hypothesis: At least the 10 mg twice daily dose of preladenant is superior to placebo     as measured by the change from Baseline to Week 12 in the mean off time.   "
151954|NCT01294787|"     This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149)     on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary     Disease (COPD).   "
151955|NCT01294774|"     This study will assess the safety and efficacy of KRP203 in clinically active subacute     cutaneous lupus erythematosus patients, who have demonstrated inadequate response to standard     treatment, such as antimalarials.   "
151956|NCT01294761|"     The main objective of this clinical trial in randomizing HIV infected patients under good HIV     control with tenofovir (TDF), emtricitabine (or lamivudine) plus lopinavir/ritonavir (LPV/r)     into switching the regimen to raltegravir (RAL) with darunavir/ritonavir (DRV/r) or     continuing the ongoing regimen to compare these two groups' estimated glomerular filtration     rate (eGFR) is to investigate whether anti-HIV treatment that does not contain TDF or other     reverse-transcriptase inhibitors (NTRI sparing regimen) can be protective of patients' renal     functions and has the same virological efficacy in comparison with a standard treatment with     TDF, or not.   "
151957|NCT01294748|"     The DESSOLVE II clinical trial is to assess the safety and performance of the     sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in     patients with symptomatic ischemic heart disease due to discrete de novo lesions in the     native coronary arteries.   "
151958|NCT01294735|"     This is a non-randomized two-part study of MK-4827 given with temozolomide in participants     with advanced cancer. In Part A of the study, the dose-limiting toxicities (DLTs) and the     maximum tolerated dose (MTD) of MK-4827 when combined with temozolomide will be found by     increasing the MK-4827 dose level in successive cohorts. In Part B of the study, participants     with advanced glioblastoma multiforme and advanced melanoma will be enrolled to further     evaluate the tolerability and efficacy of the MK-4827 + temozolomide combination.   "
151959|NCT01294722|"     This is an observational study to estimate the proportion of patients diagnosed with RA     visiting a medical internist in a general hospital in Korea who are candidates for anti‐TNF α     therapy.   "
151960|NCT01294709|"     This study will assess the safety of telcagepant in coronary artery disease (CAD)     participants with stable angina during exercise treadmill testing and evaluate whether     calcitonin gene-related peptide (CGRP) receptor antagonism by telcagepant reduces exercise     tolerance in these participants. Primary hypothesis is that telcagepant does not     significantly decrease exercise duration compared to placebo, as measured by a treadmill     exercise test; that is, the true treatment difference in exercise duration (MK-0974 -     Placebo) >= -60 seconds.   "
151961|NCT01294696|"     This was a study to estimate the proportion of participants with osteoarthritis of the     knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did     not report adequate pain relief at Baseline and to characterize their pain level over a     12-month follow-up period.   "
151963|NCT01294670|"     The purpose of this study is to find out how safe and effective treatment with a new     combination of drugs, vorinostat and etoposide, is in treating cancer. The medication     etoposide is a standard medication used in the treatment of cancer in children. Vorinostat is     an experimental drug which targets a protein(s) that control the way cancer cells grow and     divide. Vorinostat is approved by the FDA in adults with certain cancers but not approved yet     in children.      There are two parts to this study. In the first part of this study, the phase I portion, a     safe dose of the combination, vorinostat and etoposide. The goal of second part of this     study, the phase II portion, is to see how effective the combination of vorinostat and     etoposide is in treating cancer.   "
151964|NCT01294657|"     The goal of this research study is to learn if a motivation and problem solving (MAPS)     program can help improve diet and levels of physical activity in African Americans who are     overweight.   "
151965|NCT01294644|"     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of     submental fat (fat below the chin).   "
159880|NCT01190826|"     The purpose of this study is to evaluate the safety, tolerability and clinical activity of     ASM-024 in stable moderate asthma.   "
151966|NCT01294631|"     The purpose of the study is to evaluate the effects of multiple doses of hydrochlorothiazide     and canagliflozin on the concentrations of each drug in the blood and the concentration of     glucose in the blood and urine in healthy adult volunteers.   "
151967|NCT01294618|"     The aim of this study is to demonstrate the safety and the efficacy of a combination of 2     treatments shown to have some efficacy in Chronic Phase Chronic Myelogenous Leukemia (CP CML)     separately, but that have never been combined to date, and this combination is expected to     substantially increase the molecular response rates.   "
151968|NCT01294605|"     This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™     (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by     two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of     licensed Td vaccines in adults.   "
151969|NCT01294592|"     Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the     efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful     waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic     benign prostate hyperplasia (BPH).      Once consented, each subject will undergo screening procedures to ensure the prostate volume     and post void residual are within eligible range. If all entry criteria are met, subjects     will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or     watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation     will be initiated when no improvement from baseline is scored using the International     Prostate Symptom Score (version 2) (IPSS) questionnaire.      After randomisation, the subjects return to site at one month, then every 13 weeks until two     years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events     (AE's) and concomitant medication monitoring and completion of the quality of life     questionnaires are performed at each visit and the data recorded.   "
151970|NCT01294579|"     The purpose of this phase II open label study is to evaluate the safety and efficacy of     ofatumumab and bendamustine followed by maintenance ofatumumab in subjects with indolent     B-NHL who have relapsed after Rituximab treatment. A maximum of 53 subjects at least 18 years     old with Small lymphocytic, lymphoplasmacytic, marginal zone lymphoma, or follicular     lymphoma; Grades 1, 2 and 3a, will be enrolled (34 in Stage 1 and 19 in Stage 2). Subjects     should have Rituximab-sensitive disease, defined as a Partial Remission (PR) or Complete     Remission (CR) to the last rituximab-containing therapy lasting at least 6 months following     completion of therapy or subjects should have relapse or disease progression following     response to prior rituximab-based therapy and with a Eastern Cooperative Oncology Group     (ECOG) Performance status of 0 1 or 2. During the induction phase, ofatumumab 1000 mg IV on     day 1 of each cycle (cycles 1-6) will be followed by Bendamustine 90 mg/m2 IV on days 1, 2 of     each cycle (cycles 1-6).During the maintenance phase, subjects with a PR or CR after the     induction phase will receive ofatumumab 1000 mg IV every 2 months for 2 years.   "
151971|NCT01294566|"     This study is the First Time In Human study for the motilin receptor agonist, GSK1322888.     GSK1322888 is a potent and selective small molecule motilin receptor agonist, distinct from     the motilide compound structures. The aims of this study are to assess the safety, tolerance,     and pharmacokinetics of single oral doses of GSK1322888 and to identify a well-tolerated and     safe dose that will accelerate gastric emptying of a 13C stable isotope-labeled test meal in     healthy volunteers.      The study will include assessment of ECGs, vital signs, safety laboratory sampling, adverse     events, pharmacokinetics, and the 13C-Octanoic Acid Breath Test to measure gastric emptying.   "
151972|NCT01294553|"     An open label, multi-centre, non-interventional post-marketing surveillance to monitor the     safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients     according to the prescribing information   "
151973|NCT01294540|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and     healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy     adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a     single dose of 50 mg in healthy elderly volunteers.   "
151974|NCT01294527|"     The WiCS-LV system is an alternative means to providing left ventricular stimulation for     Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety     and performance of the WiCS-LV System in patients with indications for CRT.   "
151975|NCT01294514|"     The purpose of this study is to study Non-Invasive Performance evaluation of monitoring     algorithm.   "
151976|NCT01294501|"     Giving medications to children can be confusing; studies have shown that caregivers make     dosing administration errors up to 50% of the time. There are many reasons that there are so     many errors, including the fact that dosing for children is based on their weight, liquid     medications come in many different forms, and caregivers often give medicines using kitchen     teaspoons and tablespoons. Caregivers who have difficulty reading have even more difficulty     understanding medication instructions. We are developing and testing a web-based educational     module to teach caregivers how to give medications. We are focusing on the pediatric     emergency department because we know that this population has low literacy levels, and that     many antibiotics are prescribed in this setting. We anticipate that those caregivers that     view the interactive module will have increased knowledge on how to give medications once     they get home.   "
151977|NCT01294488|"     The overarching aim of the proposed study is to test the implementation effectiveness of two     implementation approaches—Remote Real-Time (RRT) using the internet telemedicine technology     and traditional Phone Consultation (PC) for training practitioners in PCIT. The study will     add to emerging knowledge about how technology can facilitate the transport of evidence-based     intervention models into field settings.   "
151978|NCT01294475|"     The goal of this project is to examine the effects of the use of cellular-phone technology in     conjunction with a parenting program entitled Planned Activities Training (PAT) on     participant enrollment, engagement, and motivation for the PAT intervention, as well as on     parent and child outcomes.   "
151979|NCT01294462|"     The purpose of the study is to assess the efficacy (prevention of vascular events) and safety     (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top     of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned     percutaneous coronary intervention (PCI).   "
151980|NCT01294449|"     MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the     MADIT-CRT IDE study examining long-term mortality.      (MADIT-CRT IDE: NCT00180271)   "
151981|NCT01294436|"     This is a long term, single arm, open label study to evaluate the safety and efficacy of     dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in     Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on     diet and exercise or on other anti-diabetic treatment will be included in this study.   "
151982|NCT01294423|"     This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and     safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who     have inadequate glycemic control with diet and exercise.   "
151983|NCT01294410|"     The purpose of this study is to determine whether BMS-936557 is effective in the treatment of     moderate to severely active ulcerative colitis in patients who have had insufficient response     and/or intolerance to other medical therapy for ulcerative colitis   "
151984|NCT01294397|"     The primary objective of the study was to characterize the effects of a single dose of     denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone     mineral density (BMD) and rheumatoid arthritis based on area under the serum     concentration-time curve (AUC) and maximum observed serum concentration (Cmax).   "
151985|NCT01294384|"     This study will investigate the safety, efficacy and acceptability of two new eye drop     formulations compared with Refresh Tears® in patients with dry eye disease.   "
151986|NCT01294371|"     The purpose of this study is to assess rates of administration of add-back therapy in     patients with endometriosis in the Russian Federation, during a 6-month course of     gonadoliberin agonist leuprorelin 3.75 mg.   "
151987|NCT01294358|"     Background:      - Pancreatic cancer is difficult to treat because by the time most cases are diagnosed, the     tumors are too large to be removed surgically. Standard intravenous chemotherapy may shrink     some of the tumor, but even with chemotherapy only about 25 percent of patients will live for     1 year following diagnosis. Several preliminary studies have shown that it is safe to give     chemotherapy directly into the pancreas in the area of the tumor, and that giving gemcitabine     over a longer period increases the amount of drug that is available to the tumor. Researchers     are interested in studying whether giving the approved pancreatic cancer chemotherapy drug     gemcitabine directly into the pancreas in the area of the cancer and at a slow rate of     infusion is a safe and effective treatment.      Objectives:      - To test the safety and effectiveness of administering gemcitabine directly to a pancreatic     tumor at a slow rate of infusion.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with pancreatic cancer that is     currently too large to be removed surgically but has not yet spread to other organs.      Design:        -  Participants will be screened with a full medical history and physical examination,          blood and urine tests, and imaging studies.        -  Participants will undergo pancreatic angiography and embolization, during which a          catheter will be threaded into the blood vessels near the pancreas and a contrast dye          will be used to show the blood vessels supplying the tumor. These blood vessels will          then be surgically closed off.        -  After the embolization, gemcitabine will be given as an infusion into the area around          the tumor over 24 hours.        -  Participants will return to the clinical center every 2 weeks after the first infusion          for additional infusions of gemcitabine, using the same procedures as above.          Participants will be monitored with frequent blood tests and imaging studies.        -  Two weeks after the fourth treatment (course 1), participants will have more imaging          studies, a physical examination, and blood tests. If the tumor is shrinking,          participants will have two more courses of treatment (eight more infusions of          gemcitabine).        -  Participants will have followup visits every 3 months for 2 years following the last          treatment and then every 6 months.   "
151988|NCT01294345|"     Background:      - Congenital malformations, sometimes called birth defects, occur because of a difference in     early human development. There are many different types of congenital malformations, and some     of these can be caused by changes in genetic material. Researchers are interested in studying     individuals with these congenital malformations to better understand the causes and the     effects of certain congenital malformations.      Objectives:        -  To understand more about what causes congenital malformations that arise in early human          development.        -  To learn if genetic causes can be found to explain why a person has a congenital          malformation.      Eligibility:      - Individuals who have been diagnosed with a congenital malformation.      Design:        -  Participants will be seen at the National Institutes of Health for a series of visits          over 3 to 4 days. Participants will be asked to provide copies of past medical records          and test results for review, and will be asked questions about pregnancy/prenatal          history, birth, newborn, medical, developmental, and family history.        -  Parents or siblings of participants may also be asked to provide information for          research purposes.        -  Participants may have additional medical evaluations as part of this study, including          any of the following tests:        -  Physical examinations        -  Other consultations as clinically indicated        -  Blood samples for genetic testing        -  Tissue biopsy for genetic testing        -  Photographs of affected areas, such as front and side views of the face and other body          parts that may be involved in a congenital malformation, like the hands and feet.        -  Other tests as indicated by a specific malformation, such as organ ultrasounds.        -  No additional invasive testing, testing requiring sedation, or testing involving          radiation is planned for this protocol. These tests, if performed, would involve a          separate consent.   "
151989|NCT01294332|"     Background:      - Many people who have traumatic brain injury (TBI) have low levels of physical fitness. Low     physical fitness causes severe fatigue that reduces the ability to perform routine daily     activities, and may also cause increased depression, anxiety, or sadness. Aerobic exercise,     such as treadmill walking or running, improves physical fitness in most people and may also     decrease fatigue and improve mood. However, more information is needed to determine if     exercise improves these conditions in people who have TBI.      Objectives:      - To examine the effect of an aerobic treadmill walking exercise program on physical fitness,     fatigue, and mood in people with TBI.      Eligibility:      - Individuals between 21 and 45 years of age who had a nonpenetrating traumatic brain injury     at least 6 months before participating; able to understand oral and written English language,     give informed consent and sign a consent form; are physically inactive (including activities     related to both job and recreation); and are able to stand and walk on a treadmill safely     without help.      Design:        -  This study requires 4 testing visits and 36 exercise visits over 14 weeks.        -  The first and third testing visits will last about 4 hours and the second and final          testing visits will take about 2 hours.        -  Testing visits will consist of a medical history and physical examination, completion of          questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall          quality of life), tests of thinking and a treadmill exercise test.        -  Participants will have treadmill exercise training 3 days per week for 12 weeks. Each          session includes a check-in, warm-up, treadmill walking at the training heart rate, and          cool-down. Thirty-two of the sessions will last for about 1 hour, and four of the          sessions will include questionnaires to fill out and will last about one-and-a-half          hours.        -  After completing the exercise training program, participants will have a final testing          visit to complete the questionnaires (about fatigue, daily physical activity, sleep          quality, mood, and overall quality of life), tests of thinking and a treadmill exercise          test.   "
152003|NCT01294150|"     The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System     when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will     be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and     safety will be reviewed based on pertinent adverse events.   "
152004|NCT01294137|"     Sleep apnea syndrome is common and increases with age. In the elderly, symptoms might be     different than in the youngest people, and its consequences might be severe and atypical     (falls, functional and cognitive decline).      Today, there is no specific tool to detect sleep apnea in the elderly. The goal of this study     is to evaluate the accuracy of oximetry for detection of respiratory disturbances in sleep     apnea in the hospitalized elderly.   "
152038|NCT01293695|"     This study is designed to determine the effect of a Hypnosis Intervention on reducing hot     flash frequency (perceived impact vs. physiologically measured impact), severity and daily     interference in post-menopausal women. It is felt that the Hypnosis Intervention will result     in significantly lower hot flash frequency, severity and daily interference scores (perceived     impact vs. physiologically measured impact) versus Structured-Attention Control.   "
152845|NCT01283139|"     To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with     moderately to severely active Systemic Lupus Erythematosus (SLE).   "
151990|NCT01294319|"     Background:        -  The adrenal glands, located above the kidneys, produce hormones called glucocorticoids          and mineralocorticoids. Glucocorticoids, especially the hormone cortisol, act on nearly          all cells in the body with effects that are especially important to the body's stress          response. They maintain heart function, blood pressure, and proper blood sugar levels,          and help regulate the body's responses to infections and injury. Mineralocorticoids help          to regulate salt and water levels in the body.        -  Blood levels of cortisol have a natural day-to-night pattern: the highest levels occur          in the morning and the lowest levels occur at night. This pattern is regulated by the          hormone ACTH, which is made by the pituitary gland, and causes increased or decreased          cortisol levels in response to the levels in the blood. Research has shown that older          men have higher ACTH and cortisol levels than younger men, and that endurance-trained          athletes have different cortisol levels than more sedentary individuals. Researchers are          interested in studying these differences in cortisol levels and their potential effects          on health.      Objectives:      - To compare cortisol levels and responses in sedentary young men and endurance-trained male     athletes and elderly men.      Eligibility:        -  Healthy men between 18 and 30 years of age who have exercised less than 1 hour each week          for the past 3 years.        -  Healthy men between 18 and 30 years of age who have regularly run more than 45 km (28          miles) per week for at least 3 months.        -  Healthy men between 65 and 80 years of age who have exercised less than 1 hour each week          for the past 3 years.      Design:        -  Participants will be screened with a full medical history and physical examination, as          well as blood and urine samples.        -  Participants will collect saliva and urine samples at home, both for cortisol          measurements. Saliva samples should be collected in the evening on 2 separate days, and          urine samples should be collected continuously for 12-hour intervals (7 AM to 7 PM and 7          PM to 7 AM) over a single 24-hour period. Participants will provide baseline blood          samples at the National Institutes of Health when they drop off the saliva and urine          samples.        -  Participants will have four separate evening/overnight tests at the National Institutes          of Health. At these tests, participants will take study drugs or a look-alike capsule to          block the effects of only glucocorticoid, only mineralocorticoid, both glucocorticoid          and mineralocorticoid, or neither. Blood, saliva, and urine samples will be collected          regularly from 7 PM to 7 AM the next morning.        -  Participants will have a final clinic test in which they will take dexamethasone late in          the evening (11 PM to midnight) and visit the National Institutes of Health by 8 AM the          next morning to provide a blood sample.   "
151991|NCT01294306|"     This phase II trial studies the side effects and how well Akt inhibitor MK2206 (MK2206) and     erlotinib hydrochloride works in treating patients with advanced non-small cell lung cancer     who have progressed after previous response to erlotinib hydrochloride therapy. MK2206 and     erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.   "
151992|NCT01294293|"     This phase I trial is studying the side effects and best dose of TLR8 agonist VTX-2337 and     pegylated liposomal doxorubicin hydrochloride in treating patients with recurrent or     persistent ovarian epithelial, fallopian tube, or peritoneal cavity cancer. Biological     therapies, such as TLR8 agonist VTX-2337, may stimulate the immune system in different ways     and stop tumor cells from growing. Drugs used in chemotherapy, such as pegylated liposomal     doxorubicin hydrochloride and paclitaxel, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving TLR8 agonist     VTX-2337 together with pegylated liposomal doxorubicin hydrochloride or paclitaxel may kill     more tumor cells.   "
151993|NCT01294280|"     This research trial studies prognostic and predictive markers in patients with early stage     non-small cell lung cancer receiving chemotherapy. Prognostic markers are patient or tumor     factors that predict patient survival independent of treatment. Predictive markers are     factors that may influence and predict the outcome of treatment in terms of either response     or survival benefit. Collecting and storing samples of tissue from patients with cancer to     study in the laboratory may help doctors learn more about cancer and identify biomarkers     related to cancer.   "
151994|NCT01294267|"     The purpose of this research study is to evaluate the safety and feasibility of the Impella     2.5 Circulatory Support System for use during mapping and ablation of ventricular tachycardia     in the setting of Ventricular dysfunction.   "
151995|NCT01294254|"     In this study the wound reepithelialization of that part of the skin graft donor site, which     is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist     wound healing dressing alone will be investigated.   "
151996|NCT01294241|"     The purpose of this study is to compare intra-individually the efficacy and tolerance of     Sericare® versus standard treatment in accelerating the epithelialization of skin lesions of     patients with Epidermolysis bullosa hereditaria.   "
151997|NCT01294228|"     This is a multi-center, prospective, observational study of patients that are admitted to the     intensive care unit (ICU). This study does not include any treatment or intervention and it     is considered Nonsignificant Risk.   "
151998|NCT01294215|"     This is a clinical study evaluating the safety and efficacy of long term administration of     oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in     patients with essential hypertension who are not at target blood pressure by the combination     of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.   "
151999|NCT01294202|"     The purpose of this study is to investigate if an investigational drug called AT13387 is     active against Gastrointestinal Stromal Tumor (GIST) that is resistant to other treatments,     and to understand more about the safety of AT13387.      Most subjects in the study will receive AT13387 along with another drug called imatinib     (Gleevec). Imatinib is a standard (approved) drug for treating patients with GIST. Some     patients may receive AT13387 on its own. As a result, we shall begin to understand the     effects of AT13387 given on its own and when combined with imatinib.We shall also find out     more about the side-effects of AT13387, and more about how the body breaks down (metabolizes)     AT13387.   "
152000|NCT01294189|"     Description of the decision making process as well as the practices of end of life care in an     ICU of a German university hospital during the period when changes of German legislation     occurred.   "
152001|NCT01294176|"     The purpose of this study is to determine if oral lipoic acid can safely help relieve     permanent optic nerve injury in patients diagnosed with acute optic neuritis. It will also     explore how the body absorbs and breaks down the study drug, and what effects it has on the     immune system.   "
152002|NCT01294163|"     Xenon is a gaseous anaesthetic agent registered in several European countries. It has been     administered safely during cardiac surgery in pilot studies. In animal studies, xenon     decreases the size of experimental myocardial infarction.      This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous     anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery     conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before     and after extracorporeal circulation. Propofol will be administered during extracorporeal     circulation in the three groups of patients.      The study will compare the postoperative myocardial damage observed 24 hours after surgery     from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The     main hypothesis is that the myocardial damage observed after xenon administration will not be     superior to the damage observed after sevoflurane administration (non-inferiority). The     second hypothesis is that the myocardial damage observed after xenon administration will be     inferior to the damage observed after total intravenous anaesthesia.   "
152005|NCT01294124|"     The investigators hypothesize that individual differences exist in resting-state cortical     attention, control, sensory, and emotion networks prior to noise exposure and these     differences predispose some to the development of bothersome tinnitus. Furthermore, the     investigators hypothesize that these changes in functional connectivity of these vulnerable     systems after noise exposure are responsible for tinnitus. The proposed study will use a     case-control cohort study design. Cases will be those soldiers who develop tinnitus and     controls will be those who do not. This will be the first prospective study of tinnitus and     will provide important information about the neurobiology of tinnitus.      If a cortical neural network etiology for bothersome tinnitus is confirmed, it will be an     astounding, powerful, paradigm shifting model for the diagnosis, prevention and, most     importantly, treatment of tinnitus. Furthermore, if a battery of neurocognitive tests can     identify soldiers at risk for the development of tinnitus then appropriate primary prevention     strategies can be introduced.      There are three Specific Aims to this project.      Specific Aim 1. To determine if soldiers who develop tinnitus display pre-deployment     differences in a set of physical, functional, cognitive, vulnerability, perpetuating factors,     pre-deployment neurocognitive scores, or neuroimaging features compared to soldiers who do     not develop tinnitus (control group).      Specific Aim 2. To determine if particular scores on neurocognitive tests or neuroimaging     features of functional/structural connectivity networks are associated with the development     of tinnitus.      Specific Aim 3. To identify a set of pre-deployment physical, functional, cognitive,     vulnerability, and perpetuating factors, neurocognitive responses, and neuroimaging features     that are associated with the development of tinnitus.      The investigators plan to recruit 200 soldiers, between the ages of 18 and 30 years who do     not have hearing loss or tinnitus and have never been deployed to military theater. The     soldier participants will undergo a variety of tests before and after deployment, which will     include a hearing test, neurocognitive tests (i.e., brain function tests), and a variety of     novel radiologic imaging studies of the brain. One of these novel radiologic imaging studies     is functional connectivity Magnetic Resonance Imaging, a proven methodology that monitors     changes in brain activity and connections based on blood flow between different brain areas     and levels of consumption of oxygen. This information is used to describe the condition of     important neural networks responsible for such things as attention, mood, sensation, vision,     hearing, and introspection or self-contemplation.   "
152006|NCT01294111|"     Physical activity is recommended in the treatment of heart failure. Elderly people demand     various forms of physical activity. Tai chi has shown to be an appreciated form of physical     activity among elderly, although there is a lack of studies focusing people aged 70 years and     older.      The overall goal with the project is to find a form of physical activity that is safe and     free from side effects, suitable for elderly people with chronic heart failure. The     hypothesis is that for patients participating in tai chi training during three months the     degree of self rated fatigue will be reduced and health-related quality of life will     increase, compared with a control group receiving ordinary care. The primary aim is to study     the effect of tai chi training on fatigue and health-related quality of life. A second aim is     to study effects on physical function and levels of brain natriuretic peptide (BNP) in blood     plasma. A tertiary aim is to describe the experience of participating in tai chi training.      A randomized controlled clinical study is planned. Ninety patients with a verified diagnosis     of heart failure in the age of 70 years or older, who experience fatigue according to the     Multi Fatigue Inventory (MFI-20), will be randomized to intervention or control group. Three     groups with 15 participants each will complete a tai chi training programme twice-weekly for     16 weeks. Data will be collected at baseline, directly after the 16 weeks of training, and 6     and 12 months thereafter. The programme is worked out by an expert in Chinese traditional     medicine to suit elderly people with chronic heart failure, and the classes are led by     experienced leaders. Before the start of the study a small pilot study was conducted to test     the feasibility of the programme. A group of seven patients completed the programme for eight     weeks without any problems.      If tai chi has a good effect on fatigue, health-related quality of life and physical     function, this form of physical activity can be a valuable complement to other medical     treatment. Tai chi has a potential to be offered to many patients to a relatively low cost.     It can be practiced in groups or in private, and also through internet connection.   "
152007|NCT01294098|"     The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve     blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a     pediatric population.   "
152008|NCT01294085|"     To assess the difference of prognosis between unresectable and recurrent biliary tract cancer     and evaluate prognostic factors.   "
152009|NCT01294072|"     This clinical trial will investigate the ability of plant exosomes to more effectively     deliver curcumin to normal colon tissue and colon tumors. Curcumin is the yellow pigment of     turmeric, a natural product with diverse biological activities. Exosomes are small     endosome-derived vesicles (50-100 nanometers [nm] in size). Previous clinical trials     conducted with oral curcumin have demonstrated only limited bioavailability even at very high     doses of 8-12 grams per day. This trial plans to address this problem of curcumin delivery by     using plant exosomes to deliver the drug to colon tumors and normal colon tissue.   "
152010|NCT01294059|"     Fibromyalgia syndrome (FM) shares many symptoms common to chronic neuropathic pain, including     the characteristic hyperalgesia of the skin (thermal, mechanical) and muscles (mechanical)     found in almost all FM patients. Milnacipran, a balance norepinephrine-serotonin re-uptake     inhibitor, has been found to reduce pain and improve physical function of FM patients.     However, little is known about the pain mechanisms that are affected by this medication.     Therefore, the investigator wants to determine the efficacy of milnacipran in reducing pain     as well as mechanical and thermal hyperalgesia of FM patients during a randomized,     double-blind, placebo controlled trial. Because the investigator expects anti-hyperalgesic     effects to coincide or precede with effects on clinical FM pain the proposed duration for     this trial is 6 weeks.   "
152011|NCT01294046|"     This investigation will gather information about a procedure called sphenopalatine ganglion     (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those who     suffer migraine headaches which may result in chronic severe disability. The SPG is a small     collection of nerve cells in the head, and is located near the base of the nose on either     side. Participation involves the surgical implantation of an electrode (small electrical     conductor) over the sphenopalatine ganglion. The electrode is connected to a stimulator which     will enable treatment for migraine headaches. Tiny electrical current is delivered to the     stimulator device by an internal pulse generator implanted in the area at the top of the     chest, to stop the migraine headaches. The implant system will be controlled with a wireless     remote provided after the implant procedure.      Participation will record headache diaries throughout the study, which will last     approximately 8½ months, and a yearly visit annually for five years.   "
152012|NCT01294033|"     Maximal consumption of oxygen (VO2max) during exercise is used in patients with chronic     obstructive pulmonary disease (COPD) to stratify perioperative risk. However, the impact of     supplemental oxygen to prevent hypoxemia during exercise on maximal oxygen consumption and     other ventilatory parameters during maximal exercise in the resting normoxic Chronic     Obstructive Pulmonary Disease population is poorly defined. The investigators performed a     randomized controlled trial in patients with COPD who underwent cardiopulmonary exercise     tests on room air and supplemental oxygen. The investigators compared maximal oxygen     consumption and other ventilatory parameters in each individual subject under the two     conditions.   "
152013|NCT01294020|"     Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to     Advagraf® immunosuppression to compare exposure and follow for safety and efficacy over one     year.   "
152018|NCT01293955|"     -  A Pilot study        -  Randomized and Double-blinded        -  Placebo controlled        -  In 2 parallel group (JOINS 200mg:Placebo = 1:1)        -  Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional          follow-up assessment up to 24 months)        -  Provide rescue medicine throughout whole clinical trial period.   "
153562|NCT01273779|"     Study will evaluate the safety and potential benefit of talactoferrin (recombinant human     lactoferrin) as an addition to the standard care for severe sepsis.   "
152019|NCT01293942|"     The percentage of patients with defined unresectable metastatic disease who will benefit from     a first-line treatment enabling secondary complete metastasectomy is unknown but limited.     Definition of optimized treatment algorithms is difficult due to very inhomogeneous patient     populations.      This open label, multicentre Phase II study primarily aims to assess the resection rate     achievable in a selected patient population with initially unresectable metastatic disease     limited to the liver only in order to evaluate feasibility, safety and efficacy with regards     to secondary resection of hepatic lesions in these patients.      The trial aims to enrol only patients meeting defined criteria of unresectability with     regards to their hepatic lesions and will exclude patients with extrahepatic lesions in order     to examine the most appropriate, highly active treatment regimen for this group of     unresectable patients with the highest probability of a successful secondary metastasectomy     with curative intent. The trial will be conducted in highly specialized centres with a track     record of successful interdisciplinary treatment approaches in the field of metastatic     colorectal cancer to allow the precise assessment of the peri-operative safety parameters as     well as an evaluation of the surgical treatment approaches.      The IXO regimen selected for this study has shown in a phase I/II study promising efficacy     and a favourable safety profile. Bevacizumab has demonstrated a significant survival benefit     in combination with chemotherapy in metastatic colorectal cancer. Therefore the study will     allow evaluation of its potential benefit in combination with the two most active current     chemotherapy regimens in the first-line and post-operative treatment setting.   "
152020|NCT01293929|"     Chemerin is a novel adipokine that might provide a link between chronic inflammation and     obesity. Pulse wave velocity(PWV) is a useful method for examining arterial stiffness,     meaning early-stage atherosclerosis. Therefore, in the present study, the investigators     examined the relationship between circulating chemerin and arterial stiffness measured using     PWV in obese persons.   "
152021|NCT01293916|"     Prospective randomized controlled trial comparing use of single leg spica with double leg     spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years     old.   "
152022|NCT01293903|"     The pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely     associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin     capsule, a Chinese medicine, could enhance heart function in chronic heart failure and     regulate the balance of TNF-a and IL-10 in myocardial infarction. In this study, to explore     the effects of Qiliqiangxin capsule on the improving heart function and immunoregulation in     patients with DCM, patients were recruited, anti-heart autoantibodies and some representative     cytokines were assayed by enzyme-linked immuno sorbent assay (ELISA), and the efficacy of     heart function improvement was compared between Qiliqiangxin capsule and placebo under the     standard treatment of DCM.   "
152023|NCT01293890|"     Chronic Obstructive Pulmonary Disease (COPD) represents one of the most challenging chronic     diseases of the 21st century: it is expected to be the fourth leading cause of death by 2030.     COPD is characterized by pulmonary and extra-pulmonary systemic manifestations caused by     partly irreversible expiratory airflow obstruction. The cornerstone of COPD management is the     prescription of single or combined inhalation therapy, such as short- and long-acting     bronchodilators, inhaled corticosteroids to possibly prevent disease progression, preserve     lung function, relieve respiratory symptoms and prevent or treat exacerbations. Given the     complex and lifelong treatment, one can expect that adherence to the prescribed inhalation     therapy is not self-evident. Adherence can be defined as the the extent to which a person's     behaviour (taking medications, following a recommended diet and/or executing life-style     changes) corresponds with the agreed recommendations of a health care provider. Inhaled     medications have an additional complexity in that patients who intend to be adherent may be     take the inhaled medication incorrectly, prohibiting proper therapeutic action. Taking less     than the prescribed amount of medication, missing doses or stopping treatment for brief or     extended periods will put the patient at risk for suboptimal disease control. Hence, the     effectiveness will largely depend on the patient's ability to manage their disease adequately     in daily life.      Using electronic monitoring, 3 studies in COPD found a prevalence of medication non-adherence     of 51% which was worse than the average prevalence of 29% (range 3-66%) found across diseases     such as hypertension, cancer, epilepsia, infections and HIV.      The existing evidence on risk factors for nonadherence in COPD is mostly anecdotic and not     guided by behavioral models. According to the integrated model of behavioral prediction     (IMBP), barriers, skills and ability and intention are the most important drivers of     adherence (i.e. medication adherence).      The aims of the study are the following:        -  To prospectively investigate the impact of medication nonadherence on time to          exacerbation (primary end-point) and exacerbation rate, FEV1, hospitalization rate and          duration, and quality of life (secondary end-points) at 1 year follow-up using          electronic monitoring        -  To investigate risk factors for medication nonadherence, using the Integrated Model of          Behavioral Prediction as a theoretical framework        -  To determine the diagnostic accuracy of different measures of medication nonadherence          (i.e. pill count, self-report and physician rating) relative to electronic monitoring.        -  To investigate the prevalence of nonadherence to other aspects of the therapeutic          regimen, i.e. the use of concomitant medications, smoking cessation, alcohol use,          physical activity, attendance to rehabilitation sessions and dietary adherence, their          interrelations, and impact (alone and in combination) on time to first exacerbation.        -  To investigate the interrelations in adherence to the various components of the          therapeutic regimen.        -  To investigate the impact of nonadherence to the other components of the therapeutic          regimen (alone and in combination) on clinical outcomes (i.e. time to exacerbation,          exacerbation rate/PPY, FEV1, hospitalization rate and duration, and quality of life at 1          year follow-up.   "
152024|NCT01293877|"     The study must be performed in 100 patients suffering from morbid obesity, the procedure will     be performed under general anesthesia doing two or three layers of suture to achieves gastric     imbrication until transform the stomach to a sleeve. The patients will be followed during the     time for 6 month, 1 year, two years and 5 years.   "
152025|NCT01293864|"     The object of this study is to analyze fresh human skin samples using several up-to-date     technologies to get parameters on the mechanical, biochemical and structural distribution of     the main components of the capillary-tissue unit.      Our working hypothesis is that both structural components of the dermis are not evenly     distributed along parallel planes. The investigators further hypothesize the the distribution     patterns determine functional and mechanical differences along dermal layers.   "
152026|NCT01293851|"     Background:      - Docetaxel, the most commonly used drug for the treatment of invasive breast cancer, has     been shown to prolong the lives of women with breast cancer and prevent the cancer from     spreading or returning. However, docetaxel is known to cause nerve damage, including     numbness, tingling, and pain, in 50 to 90 percent of breast cancer patients. This nerve     damage is called peripheral neuropathy, and can be so severe that treatment with docetaxel     may need to be stopped. Researchers are interested in studying docetaxel-related nerve damage     to determine whether certain genetic factors may predispose women to developing this     condition, and to more closely investigate the specific effects of docetaxel on the nervous     system      Objectives:      - To examine nerve damage in women with breast cancer who are being treated with docetaxel.      Eligibility:      - Women at least 18 years of age who have been diagnosed with invasive breast cancer and are     scheduled to have docetaxel treatment.      Design:        -  Participants will be screened with a full medical history and physical examination, as          well as blood and urine tests and imaging studies.        -  This study requires seven visits, one before the start of chemotherapy and six after the          scheduled treatment visits. Study procedures at each visit will take 30 to 45 minutes          and will be done in parallel with scheduled chemotherapy visits.        -  At the first visit, participants will provide blood samples; complete questionnaires to          rate and describe any existing pain, numbness, or tingling in hands and feet before the          start of chemotherapy; have nerve conduction tests; and have a skin biopsy.        -  At each visit following docetaxel treatment, participants will complete questionnaires          to rate and describe any pain, numbness, or tingling during the course of chemotherapy.          Participants will provide blood samples at every visit and have nerve conduction tests          during the second, fourth, and sixth visits. Participants will also have a second skin          biopsy, either from a site that appears to be experiencing nerve damage or (for those          who are not developing nerve damage symptoms) from a site near the first biopsy          location.   "
152027|NCT01293838|"     The primary objective is to examine whether Cipralex® is effective and safe in the treatment     of anxiety disorders in youth. The secondary objective is to identify changes in arousal and     stress response from pre- to post-treatment with Cipralex® in youth with anxiety disorders.   "
152028|NCT01293825|"     Psychotropic-related weight gain is a common concern among patients with bipolar disorder     (BD). This concern affects an individual's satisfaction with treatment and may lead to     reduced adherence and illness relapse. Patient-focused care is attentive to patient concerns     while at the same time utilizing evidence-based treatments. Ziprasidone is currently FDA     approved for the maintenance treatment of BD. Ziprasidone may be associated with less weight     gain compared to some alternative BD maintenance treatments. The proposed project will     evaluate how switching to ziprasidone may affect patient adherence, drug attitudes,     satisfaction with care and clinical outcomes (psychiatric symptoms, functional status,     weight) among BD patients concerned with weight gain.   "
152176|NCT01291901|"     The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain     scores and pain medication usage in subjects with intractable pain due to malignant disease.     A second purpose is to confirm safety and secondary efficacy measurements.   "
152037|NCT01293708|"     The purpose of this study is to understand the realities, expectations and attitudes of     patients 80+ and their families about the use of life-sustaining technology, and to document     the patient outcomes and family experiences associated with surviving and not surviving     critical illness. Specifically in this project the investigators will determine the real     outcomes of critical illness experienced by octogenarians.   "
152029|NCT01293812|"     Background : Previous studies suggest that early recognition and treatment of pain among     children is important for their cognitive development and their future response to pain     throughout their life. Oral sweet solutions have been accepted as effective pain reducing     agents for procedures in the neonatal population. To date, there have been a limited number     of published clinical trials in an emergency setting studying this type of intervention among     infants and these studies have shown conflicting results.      Objective : To compare the efficacy of an oral sucrose solution versus placebo in reducing     pain in children 1 to 3 months of age during venipuncture in the Emergency Department (ED).      Methods : A single-center, randomized, double-blind, placebo controlled clinical trial will     be conducted in an urban tertiary care pediatric university-affiliated hospital ED. The study     population is all infants from 1 to 3 months of age requiring venipuncture as part of their     planned ED management. Study participants will be randomly allocated to receive 2 ml of a 88%     sucrose solution or 2 ml of a placebo solution. The primary outcome measure is the difference     in pain levels during the venipuncture in the study population as assessed by the Face, Legs,     Activity, Cry and Consolability Pain Scale (FLACC). Secondary outcome measures will evaluate     differences of pain levels using the Neonatal Infant Pain Scale (NIPS). Crying time and     changes in heart rate during the procedure will be recorded. Side effects and adverse events     will also be noted. The investigators will also measure the number of successful     venipunctures at the first attempt. Based on previously reported data, using an alpha value     of 0,05, a power of 90% and using a 2-point difference in mean FLACC scores as clinically     significant difference, approximately 41 patients per group will be needed considering a     drop-off value of 25%. Patients' characteristics and outcomes will be compared using the     Pearson Chi-square test for categorical variables and the Student's T test for continuous     variables. A intention to treat analysis will be performed.   "
152030|NCT01293799|"     BACKGROUND: Peritonitis remains a significant problem in peritoneal dialysis. It is the     leading cause of technique failure, and contributes to mortality. The incidence is highest     during the first year of treatment. Non-compliance with the Peritoneal Dialysis (PD) protocol     is shown to be an important risk factor for peritonitis. Reinforcement of knowledge and     ability to perform PD therefore appears to be a possible way to reduce the incidence of     peritonitis. This will be studied in The PEritonitis Prevention Study (PEPS).      METHODS: The objective of this randomized, multi-centre investigation,which will include 750     new PD patients who can perform (PD) without assistance, is to evaluate if regular retraining     can reduce the incidence of peritonitis, the technique-failure rate, and the hospitalisation     days due to peritonitis compared with regular follow-up regimen. Patients in the intervention     group will tested by a PD-technique test and a questionnaire at regular intervals after     PD-start and after every peritonitis episode with focus on infection prophylaxis. If needed,     they will be retrained. The control group will be treated according to the routine of the     center.      The study is ongoing in Denmark, Norway, Sweden, Finland, Estonia, Latvia, the Netherlands,     and the UK. The study will go on for 6 years.   "
152031|NCT01293786|"     Both Kidney transplantation (KT) and Chronic Kidney Disease (CKD) patients have reduced     kidney function. Low serum magnesium is more prevalent in KT recipients. The present study     examines the difference in vascular calcification between KT and CKD and its association with     serum magnesium.   "
152032|NCT01293773|"     Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the     prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578-     versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with de     novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12.      Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary     End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death,     myocardial infarction and repeated lesion revascularization within 12 months.      Secondary End-Points: 1) impact of glucose level during the first three months following the     procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization;     2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (> 12     months) of dual antiplatelet therapy   "
152033|NCT01293760|"     The purpose of this study is to determine, in a pilot setting, if this study is feasible in     terms of recruitment, willingness to be randomized, provision of contraceptive methods, and     follow-up. The investigators hypothesize that this pilot study will be feasible in terms of     recruitment, provision of care, and follow-up.      The study will be a pilot randomized controlled trial comparing outcomes of immediate     post-placental insertion of the Copper T 380A (Group 1) to outcomes of interval insertion of     the Copper T 380A performed 6 weeks after delivery (Group 2) for patients undergoing     scheduled cesarean delivery at Mulago Hospital in Kampala, Uganda. This study will not be     powered to detect a difference, but rather the investigators will enroll all eligible and     interested women during the three-month enrollment period. Potential participants who do not     choose an IUD or who choose not to participate will be offered an anonymous opt-out survey.   "
152034|NCT01293747|"     Phase I pharmacokinetic study      Main objective:      To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone     on each of the formulations studied, after multiple-dose administration      Study design:      Randomized, controlled, open-label, parallel, pharmacokinetic study      Sites: 1      Subjects: 30 postmenopausal women   "
152035|NCT01293734|"     Bronchial asthma is a common disease and frequently encountered disease of respiratory     apparatus. It has very complex mechanism and multiple inducing factors. This study will focus     on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal     and external use, based on Traditional Chinese Medicine (TCM) theory and clinical practice.     The study will also investigate the efficacy of the Chinese drugs and treatments on Bronchial     asthma, and provide an effective therapy for this disease.   "
152036|NCT01293721|"     Osteoporotic hip fracture is common in elderly. As a result of aging population in Hong Kong,     the total number of hip fracture cases is anticipated to increase substantially in the     future, and therefore draw more resources in hospitals and healthcare cost. Osteoporotic hip     fracture usually causes severe pain and takes long time (4-8months) to recover due to     impaired healing capability in osteoporotic bones and limited mobility. Consequently, the     patients will recover very slowly as a result of low physical activities to provide     inadequate mechanical stimulation. It is also known that mechanical, vascular and biological     factors are the keys for fracture healing.      Low-magnitude, high-frequency vibration (LMHFV) treatment is a biophysical intervention to     provide whole-body vibration signals for mechanical stimulation, which has been proven to be     good in enhancing bone and muscle performance, as well as blood circulation. Our previous     study of LMHFV on femoral fracture in rats showed acceleration of fracture healing, resulted     from enhanced callus formation and maturation. Application of LMHFV on osteoporotic fractures     could shorten the period of complete callus bridging by 30%. Our clinical trial on normal     elderly also demonstrated improved muscle performance with good compliance, which is also a     critical factor for fracture healing.      In this study, the investigators therefore hypothesize that LMHFV can enhance hip fracture     healing by enhancing fracture impaction, maintaining bone mineral density, enhancing muscle     recovery, thus improving implant mechanical stability and rehabilitation in elderly patients.     The hip fracture elderly patient will be recruited and randomized into control or treatment     group. They will be assessed on the fracture healing at fixed time point. The findings of     this study will provide very useful scientific data to support the application of LMHFV for     hip fracture patients.The ultimate goal is to enhance the fracture healing and rehabilitation     in elderly patients.   "
152039|NCT01293682|"     This research will examine the effectiveness of calcitriol in treating bone loss in women who     are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected to     take part in this study. The investigators don't know if bone loss in breast cancer survivors     should be treated differently than bone loss in other women.   "
152040|NCT01293669|"     TC-6987 is a selective nicotinic α-7 receptor ligand (open channel stabilizer) that has     demonstrated potent anti-inflammatory/antioxidant properties in animal models. Following the     oral administration of a 1mg/kg dose of TC-6987 to diabetic mice (db/db mouse) for 7 weeks,     numerous metabolic improvements were observed. Specifically, plasma glucose and triglyceride     concentrations declined by approximately 30%; Hb1Ac was reduced by nearly 50%; and TNF-α     declined more than 60% relative to control db/db mice Therefore, it appears that TC-6987     could prove beneficial in reducing elevated glucose concentrations in diabetic patients as     well as in ameliorating organ damage associated with inflammation, oxidative stress and     hyperglycemia.   "
152041|NCT01293656|"     This study is being done to assess the clinical course and treatment options for Crohn's     Disease (CD) and ulcerative colitis (UC) in the populations of Eastern Europe, Middle East,     and North Africa.   "
152042|NCT01293643|"     This is a study to compare the safety and efficacy of the use of a intravaginal ovule     containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream     containing a combination Tetracycline and Amphotericin B for the treatment of bacterial     vaginosis and/or mixed or isolated vaginal candidiasis.   "
152043|NCT01293630|"     The primary objective of the study is to determine the maximum tolerated dose (MTD) based on     the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of     ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients     with advanced solid tumors.      Secondary Objectives:        -  To assess the overall safety profiles of the combination therapy        -  To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR          258063, paclitaxel, and carboplatin when used in combination        -  To document the objective tumor response   "
152044|NCT01293617|"     Berry components have been shown to influence cancer processes in cell culture studies. The     investigators will conduct a study to investigate if blackberries influence the same cancer     processes in a human feeding study.   "
152045|NCT01293604|"     The objectives of this study are the following: 1) to determine the effect of daily     consumption of whole grain barley for six week on risk factors of cardiovascular disease     compared to a diet low in whole grains, and 2) to compare the effects of daily consumption of     whole grain barley to those of whole grain oats for six weeks to determine if the response to     these two grains is different.   "
152046|NCT01293591|"     This study is being done to study the healthful benefits of eating garlic. Previous studies     suggest that garlic may help prevent cancer. The investigators are recruiting healthy     volunteers to participate in a study to determine the ways in which eating garlic may reduce     cancer risk.   "
152047|NCT01293578|"     The goal of this study is to test the relative merits of a decision aid for diabetes     medications that we have developed - Diabetes Medication Choice Cards- versus usual care in     translating comparative effectiveness research (CER) into real world clinics. This study will     involve about 20 primary care practice sites affiliated with Mayo Health System, Park     Nicollet, or Hennepin County Medical Center. There will be no recruiting done at the Mayo     Clinic.   "
152048|NCT01293565|"     The overall purpose of this study is to learn more about Hypohidrotic Ectodermal Dysplasia     (HED) and to help in identifying treatment opportunities. Several evaluations will be     conducted in this study: 1) the number of skin sweat glands you have and their ability to     produce sweat; 2) your ability to grow hair; 3) the structure of your face compared to faces     of people affected by HED; 4) molds of your teeth to see if and how they are different than     people affected by HED.   "
152049|NCT01293552|"     The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of     ANT-1207 in the treatment of acne.   "
152050|NCT01293539|"     The purpose of this study is to show that chemotherapy delivered directly through the artery     supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective     treatment alternative to conventional systemic chemotherapy, external beam radiation, and     surgical removal of the eye.   "
152051|NCT01293526|"     The purpose of this study is to correlate the three lead placement (wires that go to the     heart) possibilities and the responses from the patient's heart. This will be done with the     help of an echocardiography and SonR signals, which is an external device that is capable of     detecting sounds created by the heart.   "
152066|NCT01293331|"     The purpose of this study is to detect acute febrile episodes and dengue infection in five     Latin American countries to assess dengue seroprevalence.      Primary objectives:        -  To identify acute febrile episodes among the cohort in order to detect the presence of          dengue infection.        -  To describe the dengue seroprevalence among the cohort at baseline and at the end of the          study.   "
152067|NCT01293318|"     The purpose of this study is to investigate if there is an association between copeptin level     in serum and the severity of pancreatitis and if copeptin can be used as a predictor for     organ failure and pancreatic necrosis with or without superinfection.   "
152068|NCT01293305|"     The use of chondroitin sulfate and glucosamine sulfate has been recognized since the 70     decade in the treatment of osteoarthritis. Numerous clinical trials have demonstrated the     therapeutic properties of this association in control of osteoarthritis, especially in     reducing pain and improving movement. The combination of chondroitin sulfate with glucosamine     sulfate offers a significantly higher tolerance than most drug treatments and, moreover, has     long lasting effects even after stopping treatment.   "
152089|NCT01293032|"     This randomized pilot clinical trial studied whether the Oncotype DX gene expression     Recurrence Score (RS) would be useful for helping make a decision about which type of     pre-operative treatment, hormone therapy or chemotherapy would be a better for patients with     hormone responsive cancers that were not suitable for breast conserving surgery. The RS is     currently used to predict the risk of distant recurrence and the benefit of the addition of     chemotherapy to hormonal therapy in the adjuvant setting.   "
152090|NCT01293019|"     To study the contribution of osteopathy on the reduction of pain in adult patients with     cystic fibrosis   "
152052|NCT01293513|"     Although the introduction of Highly Active Anti-Retroviral Therapy - HAART - has dramatically     altered the course of HIV/AIDS, true cure is still unattainable and patients are required to     take these medications for the rest of their lives. As is well known, the prolonged use of     such agents is associated with serious, sometimes life-threatening side effects, metabolic     disturbances such as diabetes and an increased incidence of myocardial infarction.      In 1999, a patient with acute HIV infection was treated soon after diagnosis (Berlin     patient). However because of intercurrent conditions, treatment was interrupted on two     occasions. After the third introduction of therapy, treatment was terminated (arbitrarily)     and the patient was found to have undetectable virus throughout a follow up of approximately     18 months. The possible explanation of this phenomenon was autovaccination. Other workers     have tried Structured Treatment Interruption (STI) in Acute/Primary HIV Infection with     controversial results, possibly because there were too few cycles of treatment interruption.      In a patient treated in our center for Acute HIV infection, after initial HAART therapy, he     underwent gradually increasing interruptions of treatment from 1 to 7 weeks. After complete     cessation of treatment, the patient was followed for 3 years, where CD4 levels were normal,     CD4/CD8 ratio remained above 1 and the viral load was undetectable.      Our plan is to study patients with Acute/Primary HIV Infection, who have been treated with     HAART for at least one year. Once they have been shown to have undetectable virus (less than     40 copies HIV RNA per milliliter) and CD4 above 500 per microliter with a CD4/CD8 above 1,     they can be enrolled in the STI study.      The study will comprise 6 groups of 4 cycles of treatment/interruption with an increasing     duration treatment interruptions alternating with treatment intervals over a 33 month period.     Altogether there will be 24 treatment interruptions, lasting from 1 week to 6 weeks. During     this time the patients will be regularly monitored for clinical events and laboratory     parameters.      The purpose of the study is to determine whether patients with acute/primary HIV infection     undergoing graded STI can achieve a normal immune status and undetectable viral load on a     long-term basis.   "
152053|NCT01293500|"     Recent advances in critical care medicine have dramatically improved morbidity and mortality     of critical illness. Goal-directed therapy protocols have been instrumental in this change.     Goal-directed therapy standardizes the rapid delivery of definitive care in illnesses such as     SIRS (Systemic Inflammatory Response Syndrome) and head trauma. Although this treatment     approach has been shown to improve clinical outcomes, it has not been widely adopted outside     academic medical centers. Further improvement in outcomes of critical illness is likely if     goal-directed therapy is utilized early in the course of care. To facilitate this early     adoption, goal-directed therapeutic protocols should be developed and implemented by     specialized pediatric transport teams. The investigators hypothesize that the institution of     goal-directed therapy during pediatric interfacility transport will improve the outcomes of     critically ill children.      The GRIPIT Trial (Goal-directed Resuscitative Interventions during Pediatric Inter-facility     Transport) will compare outcomes of pediatric SIRS patients before and after the     implementation of a goal-directed therapeutic protocol during transport. This will be the     first test of goal-directed therapy in the transport environment. Data will be collected on     pediatric SIRS patients transported by the Angel One Transport Team at Arkansas Children's     Hospital before and after protocol implementation. Outcome measures will include length of     hospital stay, length of intensive care unit (ICU) stay, incidence of multiple organ     dysfunction syndrome (MODS), and required therapeutic interventions during ICU stay (TISS-28     scores). In addition, NIRS (Near-Infrared Spectroscopy) monitoring will be used as a cerebral     and somatic oxygenation trend monitor, to determine its effectiveness as a resuscitation     guide for pediatric SIRS during transport. NIRS trends are useful as a surrogate marker for     systemic venous saturations, known to decrease with severe SIRS.   "
152054|NCT01293487|"     The purpose of this study is to determine the safety and tolerability of RN564 in women with     osteopenia and healthy men.   "
152055|NCT01293474|"     With the new software tool (EDI, enhanced depth imaging) of the Spectralis® spectral-domain     optical coherence tomography (SD-OCT) it is possible to visualize and measure the choroidal     thickness. In glaucoma a vascular component is known. Therefore a difference of choroidal     thickness in glaucoma patients and healthy controls is proposed.        -  Trial with medical device   "
152056|NCT01293461|"     The purpose of this study is to assess safety and tolerability and determine the     pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of     CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.   "
152057|NCT01293448|"     The purpose of this study is to evaluate a cryoablation technique used to ablate human     esophageal mucosa.   "
152058|NCT01293435|"     This study will collect real-life data from patients with community acquired pneumonia (CAP)     OR complicated skin and skin structure infections (cSSSI) to assess the burden of the     disease, review the treatment pathways, evaluate how health resources are used and identify     any areas of unmet medical needs. The aim of the study is to compare how patients who are     admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by     collecting data to understand the patient and disease characteristics, current practice of     treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10     European countries.   "
152059|NCT01293422|"     This clinical trial is designed to study the effects of pregnane X receptor activator     rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main     hypothesis is that rifampicin raises postprandial glucose studied with oral glucose tolerance     test. The study is a non-randomized, one-phase, open-label trial. Twelve subjects will be     given 600 mg of rifampicin a day for a week. The main outcome measures are the changes in the     glucose and insulin levels during oral glucose tolerance test.   "
152060|NCT01293409|"     Bright light therapy (BLT) is widely accepted as first-line treatment of seasonal affective     disorder (SAD). However, the mechanism of action of BLT is still widely unknown. On the other     hand, in mammals, light penetrates the skull bone and reaches the brain, and extra ocular     transcranial phototransduction has physiological influences such as changed reproductive     cycles and increased brain serotonin levels. Therefore, the investigators run a randomized,     placebo controlled, double blind, dose finding study on the putative effect of transcranial     bright light in the treatment of SAD.   "
152061|NCT01293396|"     The aim of the study is to investigate meal-related treatment with either premixed Insulin     Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free     fatty acids excursions after a standard breakfast and lunch.   "
152062|NCT01293383|"     The purpose of this trial is to to investigate the safety of LEO 90105 compared with its     vehicle after multiple administration (twice daily, 5 days) in healthy Japanese male     subjects.   "
152063|NCT01293370|"     The purpose of this study is to explore, through a qualitative approach, how a group of     people with serious mental illness experienced the integration of a vocational rehabilitation     intervention during their admittance in hospital.   "
152064|NCT01293357|"     The objective of the trial is to investigate skin irritation, phototoxicity and safety of LEO     90105 and its components by patchtest (48 hours closed patch test and photo patch test) in     healthy Japanese male subjects.   "
152065|NCT01293344|"     The purpose of this study is to document differences between men and women in changes in     metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric     controlled nutritional intervention based on the Mediterranean diet in which all foods and     drinks are provided to subjects. The investigators hypothesize that the decrease in     LDL-cholesterol will be more important in men than in women.   "
160760|NCT00000197|"     The purpose of this study is to evaluate the safety and efficacy of propanolol in the early     treatment of cocaine dependence.   "
152069|NCT01293292|"     Previously the approach to treatment of osteoporosis has been to use medications which     prevent excessive resorption of bone. More recently medications that build up new bone, i.e.     anabolic treatments, have been, and are being, developed. The investigators would like to     develop a strategy for evaluating the effectiveness of anabolic therapies by studying a     currently available therapy (teriparatide). This strategy could then be used to assess new     anabolic treatments as they are developed for use in humans.      The aims of this study are 1) to fully describe the changes in bone turnover in response to     teriparatide by biochemical marker type and by time; 2) to fully describe the changes in bone     mineral density (BMD) in response to teriparatide by site, bone compartment and time.      If this study is able to identify an early response to treatment, then this will help speed     up drug development in this area, by allowing the identification of promising new anabolic     drugs and enabling us to understand their mechanism of action. This will benefit the     investigators patients as the investigators will have a better understanding of how these     drugs work.   "
152070|NCT01293279|"     The primary objective of this study is to estimate the distributions of HCV viral/human     genotypes (including IL28B and inosine triphosphatase, ITPA), and HCV RNA level among ITPA     gene among 1000 Han ethnic Chinese patients with HCV who are antiviral treatment naive at the     time the study is conducted.   "
152071|NCT01293266|"     Propofol is routinely used for general anesthesia during pediatric heart catheterisation.     Propofol infusion syndrome (PRIS) is a rare, but often fatal complication mainly defined by     bradycardia with progress to asystolia during propofol infusion. Metabolic acidosis is     regarded as an early warning sign of PRIS. In this study the effect of propofol and     sevoflurane on serum base excess, pH and lactate are examined during pediatric heart     catheterisation.   "
152072|NCT01293253|"     Many adults find it difficult to perform physical exercise during leisure. The workplace may     provide an optimal setting to encourage a healthier lifestyle. This study investigates the     effect of daily stair walking at the workplace on cardiovascular health.      The main hypothesis is that daily stair walking for 10 weeks compared with a control group     results in increased aerobic fitness.   "
152073|NCT01293240|"     The purpose of this study is to compare the overall performance of a monthly replacement     contact lens when worn for one month and when worn for two weeks.   "
152074|NCT01293227|"     This research project is a multi-year proposal, with the goals of answering and evaluating     the following:        1. Does an intramedullary locking device applied in an extra-articular distal radius          fracture improve post operative pain, diminish hospitalization, improve early return to          activity and function compared to a volar locked plate?        2. Does an intramedullary locking device applied in an extra-articular distal radius          fracture improve patient related outcome measures compared to a volar locked plate?   "
152075|NCT01293214|"     Limb transplantation surgery is the transfer of one or more limbs from a deceased human donor     to a patient with single or multiple limb amputation. Hand transplantation is an innovative     reconstructive procedure that has the potential to significantly improve the lives of hand     amputees. The purpose of this study is to develop the best practices for multiple limb     transplantation that will improve the outcomes of future limb transplant recipients.   "
152076|NCT01293201|"     The overall development plan is to show that the combination of tried-and-proven     decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine     maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a     comprehensive, safe and effective B.I.D. drug treatment regimen, indicated for the relief of     symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age     and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose,     itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or     chronic), mucus in the back of the throat, sore throat, and hoarseness]. Considering the     favorable safety and efficacy results of Phase 1 and Phase 2, the purpose of Phase 3 is to     assess and compare the safety and efficacy of the study drug in a larger group comparatively     with a placebo control group. Objectives: A) To report and compare total symptom scores (TSS)     by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal congestion,     rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study period. B)     Report any side effects or adverse drug reactions and rate the severity of any incident. C)     Compare and report each symptom score, total nasal symptom scores (TNSS), and post-nasal drip     symptom scores (PND-S) between the two study arms.   "
152077|NCT01293188|"     The bioprosthetic aortic valve replacement is a frequent intervention because of the     predominance of calcified aortic stenosis, which is the most common valvular disease, and     aging of the population.      International guidelines recommend anticoagulant therapy during the 3 postoperative months,     but the risk-benefit ratio of anticoagulation post-operatively is questioned because of the     low level of evidence available studies and their sometimes conflicting conclusions.      Questionnaires sent to practitioners have highlighted discrepancies between common practices     and recommendations.      However, there is no analysis of actual patterns of postoperative anticoagulation after     aortic valve replacement with bioprosthesis.      The aim of the ARVA observatory is to establish a cohort of 600 patients enrolled in 3 months     and had a bioprosthetic aortic valve replacement in one of the 22 surgical centers French.   "
152078|NCT01293175|"     Whole grains (WG) contain numerous physiologically bioactive compounds, a key group being     polyphenolic compounds such as ferulic acid (FA). These whole grain polyphenolic compounds     have been shown to have potent antioxidant activity. This study will evaluate bioavailability     of WG bioactive compounds and their physiological impact on health outcomes, mainly related     to inflammatory, oxidative and hormonal status, in overweight subjects.   "
152204|NCT01291537|"     The goal of this multicentric prospective randomized controlled clinical and economic study     is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal     infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe     form of Parkinson's disease.   "
152207|NCT01291498|"     This study aims to determine whether HIFU treatment is a safe and effective alternative to an     operation to remove all or part of the affected gland. The objective is to achieve     biochemical cure (assessed by normal calcium level in the blood at six weeks, six months and     one year after therapy) without affecting the patient's voice or ability to swallow.   "
152079|NCT01293162|"     Cardiovascular risk has been shown to increase with increasing blood pressure values. As a     consequence, it results mandatory to achieve lower blood pressure goals in all hypertensive     patients, taking into account that all drugs always have some side effects that can be very     dangerous and/or uncomfortable for the patients leading to a reduced compliance. Thus,     pharmacological treatment should be delayed until it results really necessary.      The availability of natural substances with a therapeutic action has modified this scenario     because of their reduced potential to cause undesirable effects (compared with drugs). In     order to choose among various nutraceuticals (natural foods compounds with health benefits,     including the prevention and/or treatment of diseases), preference should be given to those        -  produced according to the same Good Manufacturing Practice used for drugs, to be sure          that the finished product has a standard, reproducible composition        -  for which efficacy and safety in the recommended indications are supported by clinical          trials.      An example of a product with these characteristics is Armolipid Plus, a combination of     nutraceuticals with a demonstrated anti-dyslipidaemic effect. Recently, a large clinical     intervention study showed evidence that treatment with Armolipid Plus leads to a significant     decrease in the overall cardiovascular risk, measured using the Framingham Risk Score.      Progress in Research and Development in this field has led to a new patented and registered     combination of nutraceuticals: Armolipid Prev, containing orthosiphon and CoQ10, with     antihypertensive activity, berberine, red yeast, policosanol and orthosiphon with     antidyslipidaemic effect and folic acid, reducing plasma homocysteine levels.      In addition to the established anti-dyslipidaemic activity of Armolipid plus, Armolipid Prev     has a significant antihypertensive effect, which is beneficial in all those patients with     high blood pressure values without a defined indication to begin a pharmacological treatment     according to the current guidelines. The antihypertensive effect of Armolipid Prev,     documented by ambulatory blood pressure monitoring, in addition to the lowering effect on     dyslipidaemia and even on abdominal girth, represents a new opportunity for complete and     early, effective and safe cardiovascular disease prevention.   "
152080|NCT01293149|"     Knee arthroscopy is a common surgical procedure in pediatrics in which the knee joint is     visualized through a small camera to help diagnose and treat knee problems. This procedure is     commonly accomplished with the use of general anesthesia. Regional anesthesia is commonly     completed with a single injection of local anesthetic around the femoral nerve to provide     pain relief for several hours following knee arthroscopy. The intent of this study is to     examine the effects of clonidine in addition to local anesthetics for femoral nerve blockade     in providing children and adolescents post-operative analgesia. The investigators hypothesize     the addition of low dose clonidine (1 mcg/kg) provides an additional 4 hours of post     operative analgesia following arthroscopic knee surgery and reduces post-operative opiate     requirement.   "
152081|NCT01293136|"     This is a retrospective review to evaluate the efficacy of femoral nerve block in providing     analgesia following reconstructive surgery of the knee and to compare the postoperative     course of patients who received femoral nerve block with a retrospective cohort who were     cared for prior to the institution of a regional anesthesia program. The investigators     hypothesize that femoral nerve blockade limits postoperative opioid needs, improves analgesia     and facilitates discharge home when compared to intravenous opioid use following     reconstructive knee surgery.   "
152082|NCT01293123|"     The primary aim of this study is to determine the effects of the HIV integrase inhibitor,     raltegravir, in cerebrospinal fluid (CSF). This will be accomplished by collecting CSF before     and after initiation of either raltegravir or another antiretroviral, efavirenz, each in     combination with two other antiretrovirals. Assessments will include HIV RNA levels (viral     load), neuropsychological testing, mood assessments, and quality of life assessments.   "
152083|NCT01293110|"     Patients with neurological disease/injury often suffer from lower urinary tract symptoms,     which frequently have a negative impact on the patients' health related quality of life. The     prevalence of lower urinary tract dysfunction is high and the treatment is a challenge     because available treatments may fail. In this study data of patients with lower urinary     tract dysfunction treated at the University of Zürich, are prospectively and systematically     collected in a database.   "
152084|NCT01293097|"     This randomized, open label, controlled, parallel group study is designed to test whether     2-day high dose atorvastatin administration before PCI and 30-day continuous intensive     atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events,     as well as 6-month prognosis. The goal is to set up an optimized protocol for peri-PCI statin     treatment in Chinese CHD patients. Safety will also be observed.   "
152085|NCT01293084|"     Previously, the investigators and others have shown that mucociliary clearance (MCC) is     defective in patients with cystic fibrosis (CF) and it is now thought that alterations in     airway mucus rheology figure prominently in the impairment. Mucociliary clearance works by     trapping toxic particles, bacteria and viruses in the lung mucus and then quickly removing     the mucus out of the lungs. Defects in MCC typically lead to the accumulation of mucus in the     airways, and this in turn is associated with acute infections, chronic bacterial colonization     and chronic inflammation. One treatment strategy that is gaining acceptance as an important     therapy for improving MCC in adults with CF is the inhalation of the osmotic stimulus,     hypertonic saline (HS). A number of studies have shown that acute inhalation of HS (7%     saline) significantly improves MCC in adults with CF and results from a recent study indicate     that two weeks of inhaling HS leads to a significant increase in MCC that is sustained for 8     hours post inhalation and is associated with significant improvements in FEV1, FVC and     FEF25-75 values. Since MCC in patients with CF appears to be impaired by adulthood, any drug     that disrupts or slows the impairment in childhood could prove enormously beneficial in the     long-term prognosis of the disease. Nevertheless, no studies have been conducted to determine     if HS treatment improves MCC in children with CF. This is most problematic for physicians who     care for children with CF who have normal FEV1 and FVC values, since it is unclear if they     should treat these children with HS or not. This research study is designed to begin to     answer this question. The investigators hypothesize that acute inhalation of hypertonic     saline (7%) will improve MCC in CF children with normal pulmonary function. Our hypothesis     will be tested in a one-year clinical trial that will be randomized and placebo-controlled.     Twelve children with CF who are 7-12 years old and have normal FEV1 and FVC values will     participate. Our goal will be to compare MCC in these children on two study visits after     acute inhalations of placebo (0.12% saline) or hypertonic saline (HS) (7% saline) aerosol.     The investigators predict that MCC values after acute inhalation of 7% HS aerosol will be     statistically significantly greater than after placebo inhalation.   "
152086|NCT01293071|"     The SATURN ICU-trial studies the effect of antibiotic rotation on the prevalence of     antibiotic resistant Gram-negative colonisation.   "
152087|NCT01293058|"     The purpose of this study is to determine which route of administration is better for     treatment of opioid overdosed patients   "
152088|NCT01293045|"     -  Preliminary scientific studies, in both animals and humans suggest that oral consumption          of hydrolyzed collagen acts on the bone remodeling process by stimulating the activity          of osteoblasts responsible for bone formation while improving the bone mineral density          and biomechanical resistance of long bones.        -  The objective of this clinical research is to measure changes in biomarkers of bone          turnover in postmenopausal healthy women, not osteoporotic, in response to consumption          of hydrolyzed collagen for three months.        -  For this, we propose to measure blood and urinary markers of formation and bone          resorption before consumption, then 45 and 90 days after daily consumption of 10 g of          hydrolyzed collagen.   "
152446|NCT01288391|"     This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety     and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses     of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.   "
152091|NCT01293006|"     This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant     (MK-4305) on respiratory function in participants with chronic obstructive pulmonary disease     (COPD). This is a crossover study, so all participants will receive both suvorexant and     placebo while on study. The primary hypothesis of this study is that multiple doses of     suvorexant do not produce a clinically significant reduction of mean oxygen saturation (SaO2)     during total sleep time in participants with COPD, as compared to placebo.   "
152092|NCT01292993|"     The purpose of this study is to determine the effects of LX4211 and metformin on each other     when given at the same time as single doses to healthy human subjects.   "
152093|NCT01292980|"     Patients with a suspected Deep Tissue Injury (or a purple reddened area over a bony     prominence of their body, which is expected to break down into a pressure ulcer) will be     place on the Clinitron® Rite HiteTM bed to see if the air fluidized mattress decreases the     amount of tissue breakdown from their bruise.   "
152094|NCT01292967|"     The primary propose of this study is to determine the impact of ingredients and matrices on     flavanol absorption and metabolism.   "
152095|NCT01292954|"     Scientific question to be addressed: To determine the effects of acute blueberry ingestion on     vascular function and blood pressure in humans      Hypothesis: Acute consumption of blueberry induces an improvement in blood pressure and     vascular function through the impact of blueberry flavonoids on the vascular system.      Study objectives: To determine the dose-dependency of a blueberry drink on blood pressure and     vascular function in healthy subjects and to determine pharmacokinetics of blueberry     polyphenols   "
152096|NCT01292941|"     To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)   "
152097|NCT01292928|"     The primary objective of this clinical study is to determine whether the Innova Stent System     shows acceptable performance in long-term (12-month) safety rates and vessel patency when     treating femoropopliteal lesions.   "
152098|NCT01292915|"     The main aim of the study is to describes the outcomes of patients with Upper     Gastrointestinal Bleed (UGIB) in a real-life setting. Additionally analyse assessed     predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic     therapies.   "
152099|NCT01292902|"     Inspiratory muscle dysfunction is a reduction in the ability to generate pressure and force     by the inspiratory muscles. This decrease in the strength of these muscles can be attributed     to biochemical and histological changes. Some patients with CHF showed a reduction of maximal     inspiratory pressure (MIP) and inspiratory muscle endurance, and such factors known to     exercise limitation and deterioration in quality of life and worsens the prognosis of these     patients. This study aims to evaluate the Regional pulmonary distribution volume and the     influence of enclosures system thoracoabdominal in CHF patients with cardiomegaly associated     with diaphragmatic weakness during quiet breathing and during exercise for inspiratory muscle     and its correlation with functional data. The investigators evaluated a total of 31     individuals divided into two groups: CHF and control. In the control group, twelve volunteers     participated with similar age, gender and body mass index in relation to the group of     patients with CHF. The control group participants had an ejection fraction of left ventricle     (EF)> 50% without cardiac abnormalities of the cameras and MIP over 80% of predicted. To     conduct the exercise to the inspiratory muscles (EMI) was used for IMT Threshold ® device     (Threshold Inspiratory Muscle Trainer, HealthScan Products Inc., Cedar Grove, New Jersey) is     one of the most used for training of inspiratory muscles in patients with several pathologies     such as CHF. The exercise time was 3 minutes. During this period, participants were     encouraged to only breathe through the mouth and maintain a respiratory rate between 12 and     16ipm. Opto-electronic plethysmography measures the volume changes of thoracoabdominal system     by placing 89 markers formed by hemiesferas covered with retro-reflective paper, taking the     place of each of these hemiesferas determined by anatomical landmarks on the anterior and     posterior regions of the chest and abdomen. According to our study, a lower ventilation on     diaphragmatic region would lead to an increased perception of dyspnea during submaximal     exercise in this population. Moreover, the observed changes in the pattern of regional     distribution of ventilation in CHF patients compared to healthy individuals can serve as a     basis for prospective cohort studies using IMT.   "
152100|NCT01292889|"     The investigators are looking for volunteers who have a history of Major Depressive Disorder,     the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not have a     history of these disorders for a research study on genetics.   "
152101|NCT01292876|"     The objective of the study is to assess mechanical strength and function in subjects     undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of     biologic scaffolds for the restoration of both mechanical strength and function in these     subjects. This study formally evaluated healing and return of function after an extracellular     matrix device implantation in 17 male and female subjects participating at the University of     Pittsburgh under the Department of Plastic and Reconstructive Surgery who suffer from injury     with loss of skeletal muscle tissue.   "
152102|NCT01292863|"     The purpose of this study is to evaluate the impact of Delflex neutral pH (a biocompatible     peritoneal dialysis solution) on mesothelial cell viability and peritoneal transport.   "
152103|NCT01292850|"     The aim of this study is to investigate sterility of ethyl-chloride topical anesthetic spray     when used prior to an injection. The hypothesis is that the spray does not change the     sterility of the injection site after skin is prepped.   "
152104|NCT01292837|"     To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or     3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years     with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2     Anti-Epileptic Drugs (AEDs).   "
152105|NCT01292824|"     This is a phase I pilot study to determine the safety and preliminary efficacy of a novel     hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing     liver transplantation.   "
152200|NCT01291589|"     The purpose of this study is to pilot test an innovative program development project in an     open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention     on ten (10) HIV-infected men who have sex with men who report very high levels (>10 episodes)     of sexual transmission risk behavior (unprotected anal intercourse with serodiscordant     partners).   "
164390|NCT00004801|"     OBJECTIVES:      Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with     factor IX deficiency.   "
152205|NCT01291524|"     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a     pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately     following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750     calorie evening meal as compared to a single dose of the pregabalin immediate release     (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin     controlled release tablet administered with various caloric sized dinners and at bedtime as     compared to a single dose of the pregabalin immediate release capsule.   "
152106|NCT01292811|"     The objective of this research program is to conduct a multi-site clinical randomized control     trial that will evaluate the efficacy of functional electrical stimulation based upper limb     intervention for people with tetraplegia. This will involve recruiting 84 persons with     sub-acute tetraplegia across four sites (Montreal,Toronto, Fredericton and Edmonton) and will     serve to evaluate three new Canadian hand function assessments that have been specifically     developed for persons with tetraplegia. Although these assessments have been recently tested     and have shown considerable promise, further evaluation on their clinical utility (in     particular their responsiveness and validity) is required. As well, they need to be compared     with one another to determine whether any of these tests is more appropriate for clinical     applications or whether further test reduction or augmentation may be required. Having     measures that are sensitive and accurate in assessing hand function is key for systematically     evaluating emerging therapeutic interventions.   "
152107|NCT01292798|"     This is an open-label, Phase I/II study of intravitreally administered ranibizumab either     0.5-mg and/or 2.0-mg in subjects with clinical, angiographic, and ocular coherence tomography     (OCT) evidence of diabetic retinopathy with associated diabetic macular edema following     bevacizumab therapy. Thirty patients will be enrolled in this study.      Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5     mg ranibizumab administered every 30 days (±7 days) for 3 injections during the mandatory     treatment phase (Day 0, Month 1, and Month 2).      Subjects with complete resolution of diabetic macular edema after 3 intravitreal injections     of 0.5 mg ranibizumab will be treated as necessary with 0.5 mg ranibizumab to treat recurrent     macular edema for an additional 9 months (12 months from Day 0). The intent is to administer     additional ranibizumab treatment if there is evidence of disease activity documented on OCT     (e.g., intra-retinal fluid, subretinal fluid and/or cystic changes).      Subjects with residual diabetic macular edema following 3 intravitreal injections of 0.5 mg     ranibizumab will be receive 3 intravitreal injections of 2.0 mg ranibizumab administered     every 30 days (±7 days) for 3 injections at the Month 3, Month 4, and Month 5 study visits.      Beginning at the Month 6 study visit, subjects with complete resolution of diabetic macular     edema following 3 intravitreal injections of 2.0 mg ranibizumab will treated as necessary     with 2.0 mg ranibizumab injections only to treat recurrent macular edema for an additional 6     months (12 months from Day 0).      Subjects with residual diabetic macular edema following 3 consecutive intravitreal injections     of 2.0 mg ranibizumab will be treated as necessary with 2.0 mg ranibizumab to treat     persistent or recurrent macular edema for an additional 6 months (12 months from Day 0).     Focal photocoagulation or intravitreal triamcinolone may be administered at the physician's     discretion as an adjunct to ranibizumab injections beginning at Month 6 through Month 12 of     the study.      All subjects will make monthly visits for 12 months for evaluation of safety and efficacy.     All subjects will have their first injection of ranibizumab on Day 0 and undergo a safety     visit one week (±2 days) after the first injection. At subsequent visits, the subject will     have a safety evaluation at the monthly scheduled follow-up visit prior to any intravitreal     injection. Subjects will be contacted by the site personnel 1-2 days after each injection to     elicit reports of decreased vision or pain or unusual new ocular symptoms in the study eye.   "
152108|NCT01292785|"     This ultrahigh-field MRI study gives us the unique opportunity to measure changes in brain     function and structure induced by long-term opposite-sex steroid hormone administration in     transsexual subjects. Our aim is 1. to prove the influence of high-dose, long-term     opposite-sex steroid hormone treatment on functional brain response in transsexuals. 2. to     investigate the influence of hormone treatment on resting state functional connectivity and     brain morphology. 3. to investigate differences between transsexuals and healthy control     subjects in brain function and functional connectivity, brain morphology and structural     connectivity. In this longitudinal study, transsexuals and healthy control subjects will     undergo three 7 Tesla ultrahigh-field MRI scan sessions: 1. baseline (before hormone     treatment), 2. after 4 weeks of treatment and 3. after 4 months of treatment.   "
152109|NCT01292772|"     The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant     radiation therapy on reconstructed breasts.   "
152110|NCT01292759|"     Cardiac output can be monitored using different invasive devices. Nexfin HD is a new,     noninvasive device that uses model flow technology to measure stroke volume and thus computes     cardiac output (CO). To evaluate this new device the investigators compared esophageal     doppler CO to Nexfin HD CO in patients scheduled for elective abdominal surgery.   "
152111|NCT01292746|"     The purpose of this clinical study is to determine if the Erchonia® ML Scanner (MLS) low     level laser light device can help to regrow hair on the scalp of females experiencing hair     loss or thinning.   "
152112|NCT01292733|"     The main purpose of this program is to see whether periodically measuring CA-125 (tumor     marker) levels in the blood and undergoing transvaginal ultrasounds over time will be     effective in the early detection of ovarian cancer.   "
152113|NCT01292720|"     In cross-sectional and prospective cohort studies, vitamin D deficiency is associated with     increased mortality, cardiovascular events including sudden cardiac death and stroke,     diabetes, hypertension and impaired function of the immune and musculoskeletal system. The     action of vitamin D on the cardiovascular system regulates cardiac function, endothelial and     vascular smooth muscle, and, the renin-angiotensin system. Treatment with sufficiently high     doses of vitamin D may represent a promising and inexpensive intervention option. To date,     there are few data on the effect of cholecalciferol treatment in patients with chronic heart     failure. The primary objective of this study is to investigate whether oral vitamin D     supplementation improves chronic heart failure (measured with the surrogate parameter of     NT-proBNP levels at month 0 and 6).   "
152114|NCT01292707|"     Background.      Overdiagnosis of malaria is widespread in health facilities throughout Africa, a situation     that is unsustainable given the relatively high cost of artemisinin combination therapy     (ACTs) compared to older antimalarials. In addition it often denies patients treatment for     their actual illness and generates unreliable data for health planners. For these reasons the     National Malaria Control Programme introduced revised guidelines for malaria diagnosis and     treatment in 2006 restricting the recommendation for antimalarial treatment in patients over     the age of 5 years to those with a positive blood slide or malaria rapid diagnostic tests     (RDTs) result. To support this, RDTs will be introduced into primary care health facilities     in Tanzania starting in 2009.      The high accuracy of current rapid diagnostic tests (RDTs) provides the potential for a     cost-effective solution to the problem of malaria overdiagnosis. However, RDTs with revised     guidelines to restrict malaria diagnoses to RDT-positive patients have been unsuccessful     unless accompanied by unsustainable levels of supervision and training.      Primary objective.      To conduct a trial of interventions directed at prescribers or prescribers and communities     compared to control groups to improve adherence to national guidelines for prescription of     antimalarial treatment when supported by RDTs in primary health care facilities in NE     Tanzania.      Methods      All 60 participating health facilities will receive RDTs and basic training in their use and     a copy of current NMCP/MOH guidelines for each prescribing staff member. A health worker     intervention arm will, in addition, receive workplace-based interactive training and messages     from senior staff A health worker-community arm will receive the same training as the health     worker arm and in addition leaflets will be provided to RDT-tested patients providing     information on the test and the treatment given. All training materials will be approved by     NMCP in Tanzania as being consistent with current national guidelines but with the addition     that prescribers will be asked to follow RDT results in prescribing for patients of any age     This policy is in line with the most recent revision to WHO guidelines and is supported by     NMCP in Tanzania.      Study outcomes will be recorded through a 40% (2 days per week) exit survey of patients.     Anthropological and economics studies will assess the costs and acceptability of     interventions.   "
152201|NCT01291576|"     The purpose of this study is to determine whether performing colorectal resection in deep     endometriosis infiltrating the rectum is responsible for a higher rate of postoperative     digestive and urinary dysfunction when compared to rectal nodules excision (conservation of     the rectum).   "
152202|NCT01291563|"     The purpose of this study is to evaluate the effect of an 800-mg single dose of TMC207 on the     QT/QTc interval in healthy volunteers.   "
152461|NCT01288196|"     The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune     responses of CNTO 6785 after administration to healthy adult volunteers.   "
152115|NCT01292694|"     The purpose of this study is to test the hypothesis that angiotensin II plays a role in the     supine hypertension of primary autonomic failure. To determine the contribution of     angiotensin II to renin and blood pressure regulation in autonomic failure, patients with     multiple system atrophy [MSA] or pure autonomic failure [PAF] and supine hypertension will     undergo medication testing with the angiotensin II receptor blocker losartan. The     investigators will compare the biochemical and hemodynamic effects between MSA and PAF     patients. In a subset of patients, the investigators will also give the ACE inhibitor     captopril. Our primary endpoint will be changes in plasma renin activity, and subsequent     components of the circulating renin-angiotensin system, in response to angiotensin II     blockade. Our secondary outcome will be changes in hemodynamic measures during administration     of these drugs.   "
152116|NCT01292681|"     Because of metastatic liver cancer of the colon or rectum, patients will be treated with     cytotoxic drugs (chemotherapy). In the Radboud University Nijmegen Medical Centre the     investigators investigate whether the imaging techniques at an early stage of treatment can     predict which patients will have benefited from this treatment.      In the study the investigators use two different scanners: a MR (magnetic resonance) scanner     and a PET (Positron Emission Tomography) scanner combined with a CT (Computer Tomography)     scanner. An MR scanner is a large magnet and looks like a CT scanner which also makes     pictures. But instead of using X-rays the recordings are made with magnetic fields. The scan     consists of a table on which the patient will lie with the head in a half-dome with a camera.     The examination with the MR scan is not painful and not harmful.      The PET scan is a type of CT scan that makes (after administration of a radioactive liquid),     a scan of (part of) the body. The amount of radioactivity that is used for the study is so     small that it will not have an adverse impact on the patient. This research is two times     combined with a''normal''CT scan.      Using the MR scan, the investigators can research the oxygensupply, the aggressiveness of the     tumour and the degree of liver metastases that die from the chemotherapy . The investigators     can also, after administration of a MR contrast agent, investigate the blood supply of a     tumor through imaging. If you are treated with the chemotherapeutic drug capecitabine the     investigators can monitor the intake of this agent in the liver metastases. The PET CT scan     tells us more about the metabolism in the liver metastases.   "
152117|NCT01292668|"     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a     certain kind of light. When the drug is active, cancer cells are killed. Photodynamic therapy     using methyl-5-aminolevulinate hydrochloride cream may be effective against skin cancer.     PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic     therapy with methyl-5-aminolevulinate hydrochloride cream in determining pain threshold     patients with skin cancer   "
152118|NCT01292655|"     The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects     with advanced or metastatic solid tumors who no longer respond to or have relapsed from     standard therapies.   "
152119|NCT01292642|"     The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to     develop and refine a Cognitive Behavioral Therapy (CBT) intervention. The investigators aim     to develop a feasible 10-week integrated CBT intervention for the treatment of concurrent     marijuana dependence and nicotine dependence. The investigators hypothesize that the CBT     intervention, in conjunction with Nicotine Replacement Therapy (NRT) in the form of a     transdermal nicotine patch, will reduce the use of marijuana and nicotine.   "
152120|NCT01292629|"     The purpose of this multi-center clinical trail is to determine the safety and efficacy of     the iSert 251 for the correction of aphakia.   "
152121|NCT01292616|"     Atlantoaxial subluxation (AAS) is a complication of rheumatoid arthritis (RA) due to pannus     formation around the odontoid process of C2 of the cervical spine. It occurs frequently in     15-30% of all RA patients. AAS may occur relatively early in the course of disease within the     first years. The diagnosis of AAS identifies a patient population with a poor outcome. There     is evidence that combination treatment with disease-modifying anti-rheumatic drugs (DMARD)     may retard the development of AAS. However, it is not known whether treatment with inhibitors     of tumor necrosis factor alpha (TNF) may lead to regression of cervical pannus and prevention     or reduction of AAS.      Clinical studies analysing the effectiveness of TNF-inhibitors combined with conventional     DMARD therapy, in the treatment of cervical spine involvement leading to AAS, are needed.     This proposal for a pilot study aims at assessing the feasibility of an MRI-based measurement     of pannus volume in patients before and after treatment with a TNF-inhibitor.      Primary objective: To show that measurements of pannus mass with MRI is feasible. Secondary     objective: To assess whether pannus mass decreases measurably in patients treated with     TNF-inhibitors.      This pilot study is prospective, non-randomized. The choice of therapy at any time during the     study is entirely up to the treating rheumatologist.   "
152122|NCT01292603|"     This randomized, parallel-group, multi-center study will compare the pharmacokinetics and     safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in     combination with chemotherapy in previously untreated patients with chronic lymphocytic     leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously     received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in     Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6     cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of     subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and     cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug     is 24 weeks.   "
152123|NCT01292590|"     The purpose of this study is to determine if dietary fat alters insulin requirements in type     1 diabetes.   "
152124|NCT01292577|"     This study will integrate and adapt a cognitive remediation (Cognitive Enhancement Therapy     [CET]) and an affect regulation (Personal Therapy [PT]) intervention for 50 individuals with     schizophrenia that misuse cannabis. Participants will be randomized to CET/PT plus treatment     as usual (TAU) or TAU alone and treated for 18 months.   "
152125|NCT01292564|"     The purpose of this pilot study is to demonstrate the anatomical modulation of subcutaneous     fat across the waist and hips that occurs through application of the Erchonia® ML Scanner     (MLS) Laser manufactured for non-invasive body contouring of the waist and hips.   "
165658|NCT00006406|"     To analyze the relationship of dietary variables to urinary excretion of amino acids and the     relationships of specific urinary amino acids to blood pressure.   "
152126|NCT01292551|"     The purpose of this study is to determine whether Bosentan is an effective and safe treatment     to adolescent and adult (15 years and older) patients, born with one ventricle of the heart     instead of two (single ventricle physiology) and who have undergone TCPC as a palliative     surgical treatment. The aim of the TCPC operation is to use the one functioning ventricle to     pump the blood flow to the body, while the blood to the lungs is received directly from the     caval veins, and is thus a passive flow, without the aid of a ventricle to actively pump the     blood through the pulmonary circulation. The resistance in the pulmonary circulation is     therefore critical to these patients. These patients have markedly lower work capacity in     bicycle test than the general public. Furthermore they have a high risk of developing     complications e.g. loss of protein from the intestines.      Bosentan is a medication that lowers the resistance in the pulmonary circulation. It is     routinely used for patients with pulmonary hypertension. Some studies have shown that drugs     that lower the pulmonary resistance can increase exercise capacity significantly in patients     with single ventricle physiology.      In this study 80 patients will receive either placebo or Bosentan for 14 weeks. Before and     after the treatment, bicycle test along with blood samples, stool samples and quality of life     interviews will be performed. Every four weeks during the study blood samples, physical exam     and interviews will be performed to ensure the safety of the treatment.      The investigators expect to find a significant increase in work capacity after 14 weeks in     the treatment group compared with the placebo group.      Moreover the investigators hope to find a decrease in intestinal protein loss and an improved     quality of life.   "
152127|NCT01292538|"     The purpose of this study is to determine if 532nm green diode laser light is effective in     body contouring of the waist, hips and thighs.   "
152128|NCT01292525|"     The main objective of this study is to demonstrate the benefit of the withdrawal of     Tacrolimus (Prograf®) on renal function in patients one year after the end of the weaning     period. The secondary objectives will focus on assessing the risks and consequences of     withdrawal of Tacrolimus (Prograf®).   "
152129|NCT01292512|"     This study aims to develop a risk assessment tool to identify bereaved in risk of complicated     grief reactions and to implement a bereavement management programme in primary health care     based on the Dual Process Model of coping with bereavement. Furthermore to enhance     bereavement care in general practice and to enhance patients' self-management in bereavement     care.   "
152130|NCT01292499|"     The RIMAT‐De study (Rete Italiana per il Miglioramento dell'Adesione al Trattamento nella     Depressione) is a multicentric Randomized Controlled Clinical Trial aiming at identifying the     best strategies available to reduce the poor compliance of patients with antidepressant     drugs. Patients' compliance will be measured within six months of pharmacological treatment,     comparing the specific contributions of brief psychotherapy and psychoeducational     interventions: the psychoeducational intervention will encompass the monitoring of drugs'     side effects and patients' satisfaction. In the rest of the document, for the sake of brevity     the two treatments previously described will be indicated as psychotherapy and     psychoeducation. These treatments will be compared with the treatment usually carried on by     the mental health centers involved (i.e. treatment as usual, TAU). The factorial design of     the study will take into consideration the combination of the two treatments (i.e.     psychotherapy and psychoeducation) as well.   "
152131|NCT01292486|"     The purpose of this investigation is to establish that hematopoetic stem cells collected on a     new centrifugal blood separator, CaridianBCT's Spectra Optia Apheresis System, are able to     reconstitute the hematopoetic systems of patients treated with myeloablative therapy,     equivalent to hematopoetic cells harvested on the predicate COBE® Spectra platform.   "
152132|NCT01292473|"     The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled,     parallel-group study to evaluate the efficacy and safety of omalizumab administered     subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged     12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite     standard-dosed H1 antihistamine treatment.   "
152133|NCT01292460|"     The purpose of this study is to compare the efficacy and safety of the preservative-free     fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study     will enroll patients who have ocular hypertension or glaucoma and who are using timolol or     prostaglandin.      The study medication period is 6 months, but the primary evaluation of efficacy is done at 3     months.   "
152134|NCT01292447|"     The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive     that may be underutilized due to fear of pain during insertion. Although providers frequently     prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no     evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled     trials have been shown to be effective in reducing pain during IUD insertion. While many     women tolerate IUD insertion well, others have moderate to severe pain. This double-blind     randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2%     lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is     that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced     pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a     15 mm difference on the VAS with our sample size. Other data to be collected include     information regarding age, BMI, obstetric history, lactation status, time since pregnancy or     delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated     pain levels, insertion characteristics (time, difficulty, complications), side effects, and     satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily     administered option for pain control will be available to providers and patients.   "
152143|NCT01292330|"     Objective:to Study the clinical outcomes of hepatectomy with Nutritional risk After     Preoperative Nutritional Support.      Study design:      1.Prospective，randomized, controlled clinical study;2.Patients: The subjects were from Peking     Union Medical College Hospital (PUMCH).      Study arrangement:        1. The collection of patients with selected standard        2. Preoperative evaluation included nutritional status,liver function and tumor          characteristics        3. The experimental group received Preoperative Nutritional Support for 4 days,the control          group got nothing        4. Both groups received conventional therapy after operation        5. The comparation of the clinical outcomes in both groups   "
188174|NCT00308308|"     To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes   "
152135|NCT01292434|"     Lunch is in the Bag is an intervention designed to increase fruits, vegetables, and whole     grains in sack lunches prepared for preschool children. Lunch is in the Bag includes 5 weeks     of parent handouts, classroom activities related to topics in the handouts, parent and child     activities to reinforce behavioral constructs, and a one week booster 22 weeks later.      The primary study hypothesis is that Lunch is in the Bag will increase fruit, vegetables, and     whole grains in sack lunches. Additional hypotheses are that lunches at child care centers     where the program is used will have higher dietary quality than centers without the program     and that children at the centers where the program is used will have a smaller increase in     body mass index than children at centers with the program.      The study will also look at the child's home environment and the childcare center. Hypotheses     for this research question include        1. Children at centers with Lunch is in the Bag will have greater frequency of eating          fruits, vegetables, and whole grains at home than those at centers without the program.        2. Compared to parents at centers without the program, parents of children at centers with          Lunch is in the Bag will have             1. Greater knowledge, expected benefits, support, intentions, and belief in their               ability for packing fruit, vegetables, and whole grain in their child's sack lunch               daily.             2. Availability of fruit, vegetable, and whole grain in the home pantry.             3. Number of lunches with temperature in the safe range at time of service.   "
152136|NCT01292421|"     RATIONALE: Hepatitis B antigen peptide (HBsAg) vaccine may help the body build an immune     response and help prevent hepatitis B. PURPOSE: This clinical trial studies edible HBsAg     vaccine therapy in healthy participants who have undergone previous vaccination.   "
152137|NCT01292408|"     Hydroxychloroquine is a drug that has been used to treat malaria and rheumatism. It is     recently discovered that Hydroxychloroquine increases 'autophagy'. Autophagy is a process     whereby cells eat a part themselves giving them extra energy. Cancer cells use autophagy to     survive chemotherapy or hormonal therapy. Also, cancer cells use autophagy to survive in     areas of a tumor where there is a low oxygen level.      The purpose of this study is to determine whether treatment with the drug Hydroxychloroquine     leads to a decrease of autophagy in breast cancer tissue.   "
152138|NCT01292395|"     Military personnel face many physiological challenges, including sustained physical activity     and prolonged periods of negative energy balance. Chronic energy deficiency often results in     a loss of skeletal muscle mass and can reduce overall bone health. Recent evidence suggests     that dietary interventions that provide protein in excess of the current national dietary     recommendation may confer protection against the negative effects of energy deficiency on the     musculoskeletal system. The primary objective of this randomized, controlled study is to     assess the effects dietary protein intake spanning the current acceptable macronutrient     distribution range on musculoskeletal health following prolonged energy deficiency. Findings     from this investigation will improve current understanding of dietary conditions necessary to     reduce the damaging effects of caloric deficiency on musculoskeletal health in warfighters.     Furthermore, given the rise in obesity in military populations, findings may aid in the     development of nutritional weight management strategies that promote healthy weight loss     without compromising musculoskeletal health.   "
152139|NCT01292382|"     Memory is constituted by a set of mental abilities of information processing that will be     available at a later time. Flawless performance depends on several brain systems and other     cognitive domains. Normal aging is characterized by cognitive deficits that may worsen the     production capacity and quality of life. Such deficits represent variations of normal , and     may stabilize,or even better progress. Include multiple cognitive domains, such as working     and episodic memory, and attention. Despite the heterogeneity of the nature and severity of     these deficits, common characteristics were observed in neuropsychological assessment of that     population, for example, reduction in processing speed. There is an important gap in the     therapeutic approach of these individuals.      Transcranial magnetic stimulation (TMS) is a noninvasive and promising intervention, with     potential to improve memory and cognition activating networks that operate on memory or other     networks that interfere with cognitive performance. The technique relies on generating a     variable magnetic field originated from an alternating electric current applied to the human     skull reaching focal cortical regions.      This study is a sham-controlled clinical trial, randomized, double-blind study. It will be     evaluated the effects of repetitive transcranial magnetic stimulation (rTMS) on global     cognition (memory, attention, language, executive functions, planning, logical reasoning,     calculation and visual-spatial perception), especially memory, of elderly individuals with     mild cognitive impairment, included in the domain of cognitive impairment no dementia (CIND).   "
152140|NCT01292369|"     The concept of breath testing for various diseases has been around since ancient greece. It     has been hypothesized that cancer is generating a unique pattern of compounds in patients'     breath. This study is trying to characterize a novel system, based on nanoparticles     technology, for cancer diagnosis through breath samples.   "
152141|NCT01292356|"     Colon cancer is one of the most common cancers in France with more than 36,000 new cases per     year. Despite significant advances in therapeutic care, the prognosis of colon cancers with     metastases remains bad. The treatment of metastatic disease is based on chemotherapy coupled     with therapeutic antibodies. The most commonly used are anti-EGFR (Epidermal Growth Factor     Receptor), which allowed a significant increase in patient survival. They are responsible for     skin toxicity in the form of an acneiform rash which can be debilitating for patients and     require discontinuation of treatment. However, this toxicity is strongly correlated with     treatment efficacy. Understanding the mechanisms of cutaneous side effects of anti-EGFR is     therefore a major challenge to treat and better understand the association with treatment     efficacy.      The objective of this study is to investigate a link between cutaneous inflammatory response     in patients treated with anti-EGFR, serum level of anti-EGFR and treatment efficacy. It will     be conducted systematic consultations dermatology, skin biopsies and blood samples in     patients treated with anti-EGFR. From biopsies, it will be searched by an infiltration of     inflammatory cells and expression of genes involved in skin inflammation.   "
152142|NCT01292343|"     Triclosan containing dentifrices are effective in the prevention of inflammatory     complications following third molar surgery through reducing preoperative oral bacteria load.   "
165900|NCT00005716|"     To evaluate the efficacy of a community-based intervention to improve asthma management for     parents, children and health care providers.   "
152144|NCT01292317|"     Introduction:      Patients with pre-existing impaired renal function are prone to develop acute contrast media     induced nephropathy (CIN). Neutrophil gelatinase-associated Lipocalin (NGAL), a new biomarker     predictive for acute renal injury has been shown to be capable for earlier diagnosis of acute     contrast media induced nephropathy (CIN) in patients undergoing cardiac surgery.      Intravenous volume load is a widely accepted prophylaxis.      In this randomized and controlled study, only patients with the need for an intra-arterial     contrast media (CM) application will be included and receive a standardized, weight-based,     intravenous hydration before investigation.      It is the aim of this study:        1. to evaluate the magnitude of a risk for contrast media induced nephropathy (CIN)          following intra-arterial angiography in a well defined group of high-risk patients.        2. to use urinary Neutrophil gelatinase-associated Lipocalin (NGAL) as an early predictor          of contrast media induced nephropathy (CIN) after contrast media (CM) application.        3. to evaluate the clinical benefit of an early post-procedural i.v. hydration as compared          to only pre-procedural volume expansion.      Patients with markedly increased urinary Neutrophil gelatinase-associated Lipocalin (NGAL)     after investigation will be randomized into one of two study groups:      Patients of Group A will undergo standard treatment consisting of unrestricted oral fluid     intake.      Patients of Group B will additionally receive 3-4 ml/kg BW/h 0.9 % saline intravenously for 6     hours.      Endpoints:      Primary endpoint: contrast media induced nephropathy (CIN) defined by an increase greater     than 25% of baseline serum creatinine.      Secondary endpoint: NGAL, Cystatin C, and creatinine values, need for renal replacement     therapy, death.   "
152145|NCT01292304|"     Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites     in liver cirrhosis. Tolvaptan will be administered in combination with current ascites     management.   "
152146|NCT01292291|"     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find     prostate cancer and learn the extent of disease.      PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in     diagnosing prostate cancer.   "
152147|NCT01292278|"     Neuropeptide Y (NPY) may play a major role in the pathophysiology of aneurysmal subarachnoid     hemorrhage (aSAH). To investigate the correlation of NPY in cerebrospinal fluid (CSF) and     blood (serum) and the neurological outcome in the acute stage of aSAH.   "
152148|NCT01292265|"     To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment     period measured by Power/Color Doppler and Gray scale Ultrasound.   "
152149|NCT01292252|"     The purpose of this study is to determine the effects of 12 weeks of daily treatment with     teriparatide on spine fusion in adult patients who are undergoing multi-level posterolateral     spine fusion surgery for degenerative conditions of the lumbar spine.   "
152150|NCT01292239|"     The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with     placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in     treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection in Japan.   "
152151|NCT01292226|"     This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic     parameters of CellCept in patients undergoing primary kidney transplantation, in order to     assess the impact on clinical outcome and the risks of acute rejection. All patients will     receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters     will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24     weeks.   "
152152|NCT01292213|"     The purpose of this study is to investigate the role of Haemophilus influenzae and other     bacteria in causing chronic cough, through a direct comparison of chronic cough cases and     healthy controls recruited from paediatric respiratory clinics in the United Kingdom.   "
152153|NCT01292200|"     This four-and-a-half-year study will test the efficacy of viewing a theoretically based and     culturally sensitive video followed by group discussion (vs. single viewing) in increasing     mammography use. The results of this study will lead cancer control efforts to effectively     decrease breast cancer screening disparities experienced by Chinese-America women.   "
152154|NCT01292187|"     The primary purpose of this study was to evaluate the efficacy of oral calcitonin     (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral     density at increased risk of fracture. The secondary purpose of this study was to determine     if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets     administered at dinner or at bedtime.   "
152155|NCT01292174|"     The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially     increasing dose-groups of at-risk, HIV-negative, healthy volunteers. The study involves the     administration of four total injections of ibalizumab or matching placebo in each volunteer,     given once every week, at one of three dose levels. Drug administration begins at the lowest     dose. After 4 of 8 volunteers in the first group have received all study drug injections and     have completed 6 additional weeks of follow-up, an independent safety monitoring group will     review available data before approving initiation of the next higher dose-group. This process     will be repeated prior to initiation of the 3rd and highest dose-group.      All volunteers will participate in 2 separate intensive blood sampling periods of 7 days each     to test drug levels.   "
152156|NCT01292161|"     The purpose of this study is to determine the effects of silymarin on outcomes of patients     with hepatitis C.   "
152157|NCT01292148|"     The purpose of this study is to determine that the measurements of rectal and bladder     temperature are correctly consistent with core temperature by using the pulmonary artery     catheter during therapeutic hypothermia; rapid cooling, maintenance, and slow rewarming     phase.   "
152158|NCT01292135|"     The purpose of this study is to establish the safety of orally administered PCI-32765 in     combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR)     in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).   "
152159|NCT01292122|"     The purpose of this study is to evaluate the safety of VCT-01 in split-thickness skin graft     (STSG) donor site wounds and assess selected parameters of healing at the VCT-01-treated     donor site.   "
152160|NCT01292109|"     The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical     practice.   "
153585|NCT01273480|"     The purpose of this study is to evaluate the potential effects of rifampin on blood levels of     trabectedin after administration to patients with advanced malignancies.   "
152161|NCT01292096|"     Patients with frequent hospital admissions account for a disproportionate share of visits and     costs. An intervention that can bridge the gap between hospital and community based care for     a population of patients with frequent hospital admissions may offer both improved care and     cost savings if hospital admissions can be appropriately reduced. We are now using data from     our previous research to inform the development and implementation of an intervention at     Bellevue Hospital, which will bridge the gap between hospital and community based care for a     population of patients with frequent hospital admissions.      We hypothesize that such an intervention can offer both improved care and cost savings if     hospital admissions can be appropriately reduced.      In this protocol we outline a strategy to pilot a small-scale intervention on a small subset     of patients admitted to an urban public tertiary care safety net hospital who are defined by     our study criteria as at high risk for future readmission. By piloting components of the     intervention, we aim to assure the intervention functions as planned, and can deliver the     needed services to high risk patients in a seamless and patient-centered manner. The purpose     of this feasibility study is to ensure that when our intervention is implemented on a     larger scale, it appropriately serves enrolled patients needs, and that we are able to     effectively follow patients during the intervention period.   "
152162|NCT01292083|"     This clinical trial studies azacitidine in treating patients with triple negative stage I-IV     invasive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as     azacitidine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.   "
152163|NCT01292070|"     The purpose of this trial is to show that Intradermal Human Fcγ1-Fel d1 fusion protein (GFD)     is able to block the skin reaction to cat allergen in cat allergic subjects compared to the     skin reaction to cat allergen alone. This research project is also testing the safety and     tolerability of this new, experimental treatment, compared to the current treatment of cat     allergen alone.   "
152164|NCT01292057|"     The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer)     is effective in reducing of alcohol craving and drinking compared to placebo depending on     participant's baseline level of impulsivity.   "
152165|NCT01292044|"     The primary objective of this study is to evaluate the role of elastography (along with     echographic and cytological data) as a diagnostic tool for thyroid cancer   "
152166|NCT01292031|"     1. To demonstrate that colistin iv. is not inferior to meropenem in empiric treatment of          VAP regarding the final point of primary efficacy: mortality in the 28 subsequent days          and clinical healing in patients clinically evaluated.        2. To compare the safety of treatment with colistin vs meropenem in VAP.        3. To compare microbiological efficacy of treatment with colistin vs meropenem in VAP   "
152167|NCT01292018|"     The purpose of study to assess the control of dyslipidemia in the Indian diabetic population     treated with any hypolipidemic agent.   "
152168|NCT01292005|"     The purpose of this study is to determine the effects (good and bad) of giving a drug called     pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests     associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and     Drug Administration (FDA) for treatment of circulation problems, but its use in this study is     investigational, which means that the FDA has not approved it for the treatment of     pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.   "
152169|NCT01291992|"     The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac     surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.   "
152170|NCT01291979|"     This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine     injection on the relief of pain in patients undergoing tonsillectomy.      A total of 62 patients will be randomized into one of two groups (group C or group I) based     on Excel number generation.      Patients in group C will receive received normal saline intravenous injection, and patients     in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a     continuous lidocaine infusion of 2 mg/kg/hr.      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12,     24, 48 hours postoperatively.   "
152171|NCT01291966|"     The purpose of this study is to demonstrate that an intervention based on the motivational     interview directed to patients with polypharmacy to improve the Therapeutic Adherence and to     reduce the errors of Medication in major measure that the habitual intervention.   "
152172|NCT01291953|"     To verify if the screening opportunistic of Atrial Fibrillation (AF) by means of the     measurement of the arterial peripheral pulse is more effective than the habitual practice for     the early detection of AF in 65-year-old who come to Primary care   "
152173|NCT01291940|"     The goal of this study is to better understand what effect emollients (moisturizers) have on     the skin in young children and adults.      Subjects will be recruited from PI and Sub-I clinics and Oregon Health & Science University     (OHSU) research opportunities website.        1. Adult and Adolescent Study:           Moisturizer Intervention - There will be 2-3 visits for this study: a screening visit, a          baseline visit, and a final visit. Adults with a history of eczema will be asked to          apply one of four possible moisturizers to one arm and nothing to the other arm for four          weeks. The moisturizers, which will be assigned to the subjects, include either Cetaphil          Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Vaseline          100% Petroleum Jelly. Subjects can use other skin treatments as needed for their skin          condition, but may not treat the arms during the study. Non-invasive tests of the skin          will be made at Visit 1 and after four weeks (Visit 2). The skin measurements that will          be performed are:             -  Transepidermal loss (TEWL)- measures how much water is lost across the skin barrier             -  Skin Cohesion and TEWL - TEWL after 5, 10, 15, and 20 tape strips will measure skin               barrier function after tape-stripping             -  Skin electrical capacitance - measures the moisture in the top layer of skin             -  Skin pH - measures the acidity of the skin             -  Stratum corneum cohesion assay - tape-stripping to measure the protein removed from               the top layer of skin             -  Lipidomic analysis - measures the lipids, or oils, in the top layer of skin Control               - There will be 1-2 visits for this group: a screening visit and baseline visit,               which can be combined. Non-invasive tests of the skin will be taken and include the               skin measurements that will be performed are the same as the Moisturizer               Intervention group.        2. Pediatric Study: There will be 2-3 visits for this study: a screening visit, a baseline          visit, and a final visit. Infants and toddlers between 3 months and 3 years of age          without a history of skin barrier diseases will be assigned to a moisturizer, which          include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe          Moisturizing Cream, or Aveeno Skin Relief Moisture Repair Cream. Non-invasive tests of          the skin will be made at Visit 1 and after four weeks (Visit 2).             -  TEWL- measures how much water is lost across the skin barrier             -  Skin electrical capacitance - measures the moisture in the top layer of skin             -  Skin pH - measures the acidity of the skin   "
152174|NCT01291927|"     The purpose of this study is to investigate the feasibility, safety, and long-term prognosis     of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of     early-stage (pTis/pT1/pT2) periampullary carcinoma with or without lymph node metastasis   "
152175|NCT01291914|"     The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005     for the treatment of pain in patients with osteoarthritis of the knee.   "
152177|NCT01291888|"     The investigators postulate that nebivolol will be more effective than an equivalent dose of     a comparative BB, specifically sustained release metoprolol succinate, in improving the     availability of NO, lowering blood pressure, and reducing albuminuria with implications for     slowing progression of CKD and cardiovascular protection in this high risk population.      The objective of this proposal is to conduct a randomized pilot clinical trial to determine     the relative efficacy and tolerability of nebivolol versus sustained release metoprolol     succinate in improving blood pressure in patients with CKD and albuminuria. The primary     endpoint would be a decrease in asymmetric dimethyl arginine (ADMA). Secondary endpoints     would include a reduction in blood pressure, urinary F2-isoprostanes and albuminuria.   "
152178|NCT01291875|"     The studies that correlate periodontal disease (PD) and diabetes mellitus (DM) suggest that     individuals with poor glycemic control are at increased risk for developing infections.     Despite being controlled for other important risk factors, diabetic patients are three times     more likely to develop PD, and therefore, periodontitis has been proposed as the sixth     complication of DM.      Besides the effect of diabetes on DP, the reverse has also been studied over the past 15     years, through the idea that chronic and acute infections can directly affect the tissue     resistance to insulin. Recent studies have provided evidence that controlling periodontal     infection has an impact on improvement of glycemic control in diabetes mellitus patients. The     vascularity of the inflamed periodontal tissue serves as a gateway to inflammatory mediators,     pathogenic bacteria and their products into the bloodstream. Some researchers have suggested     that periodontal treatment in type 2 diabetes mellitus (DMT2) patients, results in beneficial     effect on the level of glycemic control. However, there is no conclusive evidence to support     this hypothesis.      This research project aims to determinate the impact of periodontal therapy on metabolic     control in DMT2 individuals, and determinate the possible association between periodontal     disease and DMT2. For the HbA1c outcome this clinical trial had a sample size calculation     estimated at 120 patients. For the inflammatory serum markers this study had a sample size     estimated at 22 individuals. Blood samples will be collected for evaluation of Hba1c and     inflammatory serum markers. This data will highlight the possible role of periodontal therapy     on DMT2 metabolic control.   "
152179|NCT01291862|"     Obstructive sleep apnea is a common disorder linked to serious long-term adverse health     consequences; such as hypertension, metabolic dysfunction, cardiovascular disease. Retinal     vascular occlusion is related to many systemic illnesses especially hypertension. Obstructive     sleep apnea is also related to vascular endothelial dysfunction and vascular endothelial     growth factor elevation which causes vision threatening complications of retinal vascular     occlusion. Therefore the relationship between obstructive sleep apnea and retinal vascular     occlusion should be studied.   "
152180|NCT01291849|"     After nasal surgery, emergence cough or straining will produce venous engorgement and     increase bleeding from the surgical site, so the necessity for smooth extubation without     severe cough during emergence provides a challenge for the anesthetists. Recently,     remifentanil is commonly used short-acting opioid, and several studies have demonstrated the     antitussive effect of remifentanil via effect-site target-controlled infusion during     emergence. However, there may be gender difference in response to opioid, and the previous     studies about antitussive effect of remifentanil are targeted at female patients and there is     no investigation of effect site concentration of remifentanil for male patients undergoing     nasal surgery. The purpose of this study is to evaluate the effect-site concentration of     remifentanil via target-controlled infusion for preventing cough in man after sevofluorane     balanced anesthesia.   "
152181|NCT01291836|"     AKINESIS is a clinical study to assess the utility of blood and urine NGAL tests in     predicting worsening kidney function in patients who present with acute heart failure (AHF)     and who are treated with diuretics. It is believed that rising NGAL levels in the blood     and/or urine can predict acute kidney injury. It is also believed that patients who are     admitted to the hospital with high NGAL levels in the blood/urine will have poorer outcomes.   "
152182|NCT01291823|"     Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over     30 fractions, and concurrent with Gefitinib.   "
152183|NCT01291810|"     The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II     clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of     clinical efficacy are promising.      The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in     subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to     anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune     responses and the safety elicited by TNF-K will also be evaluated.   "
152184|NCT01291797|"     This study aims to examine performance on a neurological screening test, the Dubowitz, and     sleep wake cycles on amplitude integrated electroencephalogram (AEEG) in neonates with     congenital heart disease (CHD) as a way to potentially predict longterm motor outcome. It     will compare the results of these studies to neonates without CHD.   "
152185|NCT01291784|"     TGF-β is a cytokine that is found to be upregulated in the bone marrow of patients with     myelofibrosis. This cytokine likely plays a dual role in promoting myelofibrosis and     myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. The     investigators propose that inhibiting the TGF-β signaling pathway in MF will decrease the     fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation.     This is a novel approach to the treatment of patients with myelofibrosis.   "
152203|NCT01291550|"     The diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical     symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The     purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify     neurodegenerative conditions and ADHD based on breath testing.      Alveolar breath will be collected from healthy volunteers, patients with extrapyramidal     conditions, patients diagnosed with dementia and from ADHD subjects. The discriminative power     of a tailor-made Nanoscale Artificial Nose (™NA-NOSE) containing an array of six     nanomaterial-based sensors will be tested. Discriminant factor analysis will be applied to     the NA-NOSE signals in order to detect statistically significant differences between the     sub-populations, and classification success will be estimated using leave-one-out     cross-validation. The identification of NA-NOSE patterns will be supported by analyzing the     chemical composition of the breath using gas-chromatography in conjunction with     mass-spectrometry (GC-MS).   "
152186|NCT01291771|"     Cardiovascular diseases are the leading cause of mortality in patients with end stage renal     disease (ESRD). They often have myocardial ischemia (a major predictor of mortality) on non     invasive testing (Stress echocardiography and/or myocardial perfusion scintigraphy) but the     incidence of significant coronary stenosis (>70%) is low. The goal of this observational     study is to evaluate the incidence and clinical outcomes of proven myocardial microvascular     disease in patients with end stage renal disease scheduled or not for kidney transplantation.     These patients routinely undergo non invasive detection of myocardial ischemia. Patient     included in the study will be followed up for 2 years for major cardiovascular events.     Patients with detected myocardial ischemia during non invasive testing are being explored by     coronary angiography. During coronary angiography additional detection of myocardial     microvascular disease is being performed by simultaneous measurement of Fractional Flow     Reserve (FFR) and Coronary Flow Reserve (CFR) followed by calculation of the index of     microcirculatory resistance (IMR).      Comparison of cardiovascular outcomes between patients with and without myocardial ischemia     and patients with and without myocardial microvascular disease will be performed.   "
152187|NCT01291758|"     The purpose of this study is to determine if submaximal exercise by bicycle stress tests with     pulmonary measurement of VO2MAX plus maximal isometric hand grips on 2 consecutive days     causes a higher level of exertional exhaustion in GWI compared to healthy veterans (HVets).   "
152188|NCT01291745|"     The present study is designed to determine the mutational status of markers (TET2 and PLCb2,     cytogenetic aberrations) together with methylation status of the above genes using bone     marrow and matched buccal cell samples from MDS patients who necessitate to start a treatment     (i.e. EPO, Lenalidomide, Azacytidine). All patients included in the study will be followed     for at least 2 years.   "
152189|NCT01291732|"     The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and     pharmacodynamics in Asian healthy males administered a single dose of BI 135585.   "
152190|NCT01291719|"     The purpose of this study is to study the use of a counterbalancing system of glucose and     insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can     produce tight glycemic control without hypoglycemia; study to develop a closed loop for use     in intensive care units and surgery   "
152191|NCT01291706|"     Patients with mild to moderate traumatic brain injury (TBI) are at risk for secondary     neurological deterioration. Their outcome within the first week after injury could be     predicted by clinical signs, brain CT scan and transcranial doppler (TCD) on admission to the     emergency room. The investigators aim to evaluate the diagnostic performance of TCD to screen     patients presented with mild to moderate TBI and mild lesions on CT scan, i.e., Trauma Coma     Data Bank, TCDB classification II. The principal outcome measure is the negative predictive     value of TCD.   "
152192|NCT01291693|"     The aim of this study is to investigate whether motivation-tailored alcohol interventions are     more effective when delivered by person or by computer-generated feedback letters. A sample     of 920 general hospital inpatients with risky drinking will be recruited through a     computerized screening procedure. Patients with more severe alcohol problems will be excluded     from the study. Participants will be allocated by time frame randomization to one of three     study arms: (1) personal counseling based on Motivational Interviewing, (2) computer-expert     system intervention that generates individualized feedback-letters, and (3) control group     (treatment-as-usual). The interventions differ in their channel of delivery, but not     regarding their content. Both intervention groups receive interventions at three time points:     directly after the baseline-assessment at the general hospital, and 1 and 3 months later by     mail and phone, respectively. Outcome will be assessed six, 12, 18 and 24 months after     baseline.   "
152193|NCT01291680|"     Chronic pain is common. Up to 10% of the Population has been estimated to suffer from chronic     pain and up to 5% of the female population has been estimated to suffer from widespread,     chronic pain and tenderness, thus fulfilling American College of Rheumatology (ACR) criteria     for classification of fibromyalgia syndrome (FMS). FMS is characterized by the presence of     both allodynia and hyperalgesia. FMS is also characterized by disturbances of the autonomic     nervous system such as orthostatic intolerance, postural tachycardia etc. The effect of these     conditions during gestation and post partum periods is not well known.      Parturition is a complex process which involves multiple endocrine and physiological changes     within a short period of time. Severe pain is an important attribute of this natural process.     The purpose of the current study is to evaluate the impact of chronic central pain on the     process of parturition. Our hypothesis is, that women demonstrating signs, symptoms and a     history of central pain, before the onset of active labor, will differ from women not     demonstrating such traits; these women may require earlier higher does of analgesia, and may     demonstrate increased hemodynamic lability during labor and delivery.   "
152194|NCT01291667|"     Breast cancer is the most common malignant disease and the most frequent causes of cancer     mortality in females worldwide. The situation is same as the world in China. Trastuzumab has     been proved valuable treatment for HER2-positive breast cancer patients. Cipterbin® is     developing by Shanghai CP Guojian Pharmaceutical Co.Ltd.Now we carried on the phase III trial     in order to prove Cipterbin® 's efficacy and safety.   "
152195|NCT01291654|"     The investigators propose that paracetamol will be similarly effective to ibuprofen in     treating PDA in the premature neonate, with fewer side effects.   "
152196|NCT01291641|"     The purpose of this study is to evaluate the additional effect of probucol or concomitant     administration of cilostazol and probucol on mean carotid artery intima-media thickness (mean     IMT) at year 1, 2, and 3.   "
152197|NCT01291628|"     Capecitabine is a common anti cancer drug. One of the most common side effects is a syndrome     called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness     and painful sores. Quite often the drug dose is reduced to suboptimal level due to this side     effect. There is no way to prevent or an effective way to treat this side effect. The     investigators aim is to investigate whether wearing socks which contain copper fibers may     prevent or alleviate the patient symptoms.   "
152198|NCT01291615|"     To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant     therapy after hemihepatectomy   "
152462|NCT01288183|"     The aim of this study is to determine whether a powerful technique of noninvasive brain     stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking     and constitute a treatment of tobacco addiction.   "
152208|NCT01291485|"     The purpose of this study is to develop and examine the feasibility and initial efficacy of a     computer-based intervention to improve medication adherence among people living with HIV.   "
152209|NCT01291472|"     The purpose of this study is:        -  to document ketorolac disposition (concentration/time profile, protein binding,          metabolism) and its covariates following intravenous (iv) administration of ketorolac          right after caesarean section and to compare those observations (n=32) with non-pregnant          state (n=8) (intra-subject PK comparison)        -  to document biochemical tolerance of ketorolac        -  to evaluate if optimalisation of ketorolac dose regimen during pregnancy and labor are          appropriated and needed        -  to quantify the neonatal exposure to ketorolac through excretion in the breast milk   "
152210|NCT01291459|"     Background and Rationale      Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have     demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared     well tolerated with low metabolic toxicity. No data are currently available concerning the     combination of these 2 drugs.      Hypothesis      Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive     patients infected by CCR5 HIV-1 previously treated for 6 months with a     Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.   "
152211|NCT01291446|"     Background Some patients complain of excessive evacuation, which may become socially     disabling (Azpiroz F & Malagelada J-R, 2005). However, there no systematic investigation on     the range of gas evacuation in healthy subjects and in subjects complaining of flatulence     under basal conditions and in response to a high-flatulogenic diet (Azpiroz F & Levitt DG,     2009).      Hypothesis Patients complaining of excessive passage of gas per anus have more intestinal gas     production and more anal gas evacuation during basal conditions and in response to a high     flatulogenic diet than healthy subjects. This abnormality is related to the differences in     colonic microflora.      Objectives        -  To determine the normal range of intestinal gas evacuation under basal conditions and in          response to a high flatulogenic diet.        -  In patients complaining of flatulence, to determine whether intestinal gas evacuation          under basal conditions and in response to a high flatulogenic diet is increased.        -  To identify differences in the microbiota pattern in subjects with normal and excessive          anal gas evacuation.        -  In patients complaining of flatulence, to determine the segmental distribution of          intestinal gas after a diet challenge.      Methods Healthy subjects (n=20) and patients complaining of flatulence (n=30) will undergo a     3-day basal phase on their current diet and a 3-day challenge phase on a high-flatulogenic     diet; patients will be followed-up for 7 days on a low-flatulogenic diet. The following g     measurements will be performed: daily measurement of the number of anal gas passages with an     event marker, continuous recording of anal gas evacuation in the laboratory using an     electronic leakage-free gas collection system, colonic flora analysis by fecal sampling, and     segmental gas distribution in the gut by abdominal computer tomography (CT) imaging.      Relevance These studies will allow to develop the normal range of anal gas evacuation during     basal conditions. Furthermore, a provocative test will be developed for the diagnosis of     excessive gas production in patients complaining of flatulence. This data will allow a proper     diagnosis of these patients and will pave the path for a rational management and for the     development of evidence-based treatment strategies. This pilot study will allow a proper     design with adequate sample size calculation in future interventional studies.   "
152212|NCT01291433|"     Radiation-induced brachial plexopathy (RIP) is a rare and severe delayed peripheral nerve     complication of radiotherapy, that is spontaneously irreversible with no medical treatment to     limit or reduce symptoms. The investigators planed in RIP a randomized double blind clinical     trial, using a pentoxifylline (P)- tocopherol (E)- clodronate combination versus placebo, to     assess a possible symptomatic regression by a sensory-motor neurological quantifiable and     reproducible score (modified Subjective Objective Medical management Analytic, SOMA).      The investigators previously developed a successful PE treatment in symptomatic RI injuries     via the antioxidant pathway, in clinical phase II and III trails and experiments obtaining a     major significant radiation-induced fibrosis regression, then the PE clodronate combination     (PENTOCLO), obtaining a rapid and significant healing of mandible osteoradionecrosis and     significant neurological signs regression (- 35% modified SOMA score at 18 months) in 50     partial RIP.      The aim of this phase III randomized clinical trial is to show PENTOCLO efficiency and its     tolerance in long survival patients irradiated before for cancer and presenting with partial     RIP of upper or lower legs.      The investigators calculated to include 60 patients to show a significant clinical difference     between the two groups after 18 months of treatment: PENTOCLO[Pentoxifylline 400 (2x/d) +     vitamine E 500 (2x/d) + intermittent Clodronate 800 (2/d, 5d/7)] versus triple placebo, with     prednisone 20 (2d/7) for all patients.      RIP is assessed before treatment and every 6 months by a standardized sensory-motor     neurological (SOMA 95 modified by NCI-CTC 99) score used for main criteria at M18, and     various neurological scales of assessment (Visual Analog Scale for pain / VAS for     paresthesia, Neuropathic Pain Symptom Inventory [NPSI], Overall Disability Sum Score [ODSS],     muscle testing, Nine hole peg test / Timed 25-Foot Walk), quality of life (SF36, Patient     Global Impression of Change and Clinical Global impression of Change [PGIC/ CGIC]) and     electrophysiology.   "
152213|NCT01291420|"     The aim of this study is to evaluate the immunogenicity and clinical efficacy of intradermal     vaccination with autologous RNA-modified dendritic cells (DCs) - engineered to express the     WT1 protein - in patients with limited spread metastatic solid tumors, i.e. breast cancers,     glioblastoma grade IV, sarcomas, malignant mesothelioma and colorectal tumors. Based on the     results of our previously performed phase I study with autologous WT1 mRNA-transfected DC,     the investigators hypothesize that the vaccination with DC will be well-tolerated and will     result in an increase in WT1-specific CD8+ T cell responses.   "
152214|NCT01291407|"     The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting     toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined with     radiation therapy for locally advanced or recurrent gastric cancer.   "
152215|NCT01291394|"     This is a National, Multicentre, Observational Registry to study adherence and long term     outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth     hormone treatment from hospitals in France and to assess the level of adherence of subjects     receiving SAIZEN® via Easypod™.   "
152344|NCT01289717|"     There is a need to develop blood and/or urine tests that will help to detect early signs of     rejection in people who have had kidney transplant. Researchers will examine blood, urine,     and tissue samples and try to identify genetic markers for certain conditions like rejection,     response to therapy, and scarring of the kidney. By studying gene patterns, researchers hope     to be able to diagnose these conditions earlier and improve kidney survival.   "
152216|NCT01291381|"     While allergen specific immunotherapy (SIT) is highly effective for allergic diseases in     children, the underlying immunological mechanisms are unclear. Regulatory T (Treg) cells may     be crucial in induction of tolerance.      Our aim was to investigate the role of CD4+CD25+Foxp3+ T cells and IL-10-secreting type I T     regulatory (Tr1) cells in the response to one year of cluster SIT to Dermatophagoides     pteronyssinus for allergic rhinitis in children.      CD4+CD25+Foxp3+regulatory T cells and IL-10-secreting type I T regulatory (Tr1) cells were     analyzed in children allergic to Dermatophagoides pteronyssinus during one year cluster     specific immunotherapy (SIT) in a prospective and randomized study. Peripheral blood     mononuclear cells (PBMCs) were collected from 25 children receiving SIT and 21 receiving     pharmacotherapy. The frequencies of CD4+CD25+Foxp3+ T cells and allergen-specific     IL-10+IL-4-, IFN-γ+IL-4-, IL-4+IFN-γ-CD4+ T cells were measured by flow cytometry. Production     of IL-4, IFN-r, and IL-10 in supernatants from allergen-stimulated PBMC culture was measured     by ELISA. Finally, the suppressive effect of CD4+CD25highTreg cells from both groups was     estimated.   "
162506|NCT00002352|"     The purpose of this study is to see if lobucavir is a safe and effective treatment for     cytomegalovirus in patients with AIDS.   "
152217|NCT01291368|"     The aim of this study is to investigate if sedation of Intensive Care Unit (ICU) patients     influences the development of delirium during their ICU stay and if incidences of delirium     have an impact on the development of Post-traumatic Stress-Disorder (PTSD).      Hypothesis 1:      Patients who are minimally sedated, remember staying in ICU and experiences fewer episodes of     delirium than patients that are heavily sedated      Hypothesis 2:      Former delirious patients are more likely to develop PTSD      Hypothesis 3:      Delirium decreases health-related quality (HRQoL) of life after discharge   "
152218|NCT01291355|"     The aim of the study is to evaluate the efficacy of a specific maternal position to correct     fetal position in occipito-posterior during the labor.      The investigators hypothesize that the maternal position described by the Dr de Gasquet     facilitate the rotation in occipito-anterior during the labor.      The calculated sample size is 438 participants (219 in each group)   "
152219|NCT01291342|"     Preeclampsia is a form of hypertension that is unique to human pregnancy. The incidence of     the disease ranges between 2 and 7 percent in healthy nulliparous women. The etiology of     preeclampsia is unknown.      Women with preeclampsia may exhibit a symptom complex ranging from minimal BP elevation to     derangements of multiple organ systems. The renal, hematologic, and hepatic systems are most     likely to be involved.      More than 100 clinical, biophysical, and biochemical tests have been recommended to predict     or identify the patient at risk for the future development of the disease.      The results of the pooled data for the various tests and the lack of agreement between serial     tests suggest that none of these clinical tests is sufficiently reliable for use as a     screening test in clinical practice. As a result there is obviously a great need to develop a     novel technology for the early detection of this pregnancy complication before its clinical     manifestations appear. An early detection can help in early treatment to prevent or at least     minimize the sequel of this disease.      The aim of this project is the early detection of Preeclampsia and other pregnancy     complications using volatile biomarkers appearing in exhaled breath and/or blood samples,     using a simple and inexpensive toll termed NA-NOSE.      Phase-I: The primary phase of this project is the comparison between volatile biomarkers'     patterns of pregnant women suffering from Preeclampsia, pregnant women that are considered     to have Normal Pregnancy, and healthy Non-Pregnant women.      Phase-II: The secondary phase of this project is the ability to predict Preeclampsia, as     compared, head-to-head, with other potential predictors used in the current clinical     practice.   "
152220|NCT01291329|"     The purpose of this study is to investigate the safety and efficacy of intracoronary human     umbilical Wharton's jelly-derived mesenchymal stem cell (WJ-MSC) transfer in patients with     ST-segment elevation acute myocardial infarction.   "
152221|NCT01291316|"     In animal, the GABAergic system modulates central sensitisation, which is a key phenomenon in     pain processing. The development of GABAA agonists targeting the subunits of the GABAA     receptor implicated in nociception, but not the subunit implicated in sedation is attractive     as it opens new perspectives of testing the role of GABAergic modulation of pain processing     in human volunteers. The purpose of this subproject is to test the effect of the specific α2     and α3 agonist but sparing α1 effect TPA023 on a human model of peripheral and central     sensitisation and to correlate its pharmacodynamic effect with the pharmacokinetic of the     compound.      The results would contribute to clarify the potential role of these α2/α3 agonist but sparing     α1drugs in clinical pain conditions.   "
152222|NCT01291303|"     The analysis of flow and pressure curves generated by ventilators can be useful in the     individuation of patient-ventilator asynchrony, notably in COPD patients. To date, however, a     real clinical benefit of this approach to optimize ventilator setting has not been proven.     The aim of the present study was to compare: optimized ventilation, driven by the analysis of     flow and pressure curves, and standard setting (same initial setting, same time at the     bedside, same physician, while the ventilator screen was obscured with numerical data always     available). The primary aim was the normalization of pH at two hours, whilst secondary aims     were change in PaCO2, respiratory rate, patient's tolerance to ventilation (all parameter     evaluated at baseline, 30, 120, 360 minutes and 24 hours after the beginning of ventilation).     70 patients (26 females, aged 78±9 years, PaCO2 74±15 mmHg, pH 7.28±0.05, mean±SD) have been     enrolled, with no basal difference between the two groups.   "
152223|NCT01291290|"     The purpose of this study is to investigate the effect of platelet infusion prior to transfer     to a vascular surgical department in patients with a ruptured abdominal aortic aneurism.   "
152224|NCT01291277|"     Patients with liver disease frequently present to the hospital with bleeding from dilated     veins in their foodpipe (called esophageal varices). The current standard of care is to     perform endoscopic variceal ligation (placing rubber bands around the varices through an     endoscope)in patients presenting with bleeding varices. Patients generally receive ligation     at the time they come in with bleeding and then return at regular intervals to have repeat     ligation in order to eradicate the varices. However there have been no studies to determine     the appropriate intervals for esophageal variceal ligation until eradication. We will conduct     a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in patients     that have presented with bleeding varices. Our hypothesis is that one-week ligation will     achieve more rapid eradication than the two-week interval with a greater proportion of     patients achieving variceal eradication at 4 weeks after the index bleeding episode.   "
152225|NCT01291264|"     Julius Schachter, PhD, (Department of Laboratory Medicine, University of California, San     Francisco) and Susan S. Philip, MD MPH (Department of Medicine, University of California, San     Francisco) are conducting a study to evaluate the Abbott RealTime CT/NG polymerase chain     reaction [PCR] assay (which is a nucleic acid amplification test [NAAT]) for detecting two     sexually transmitted bacteria, Chlamydia trachomatis [CT] and Neisseria gonorrhoeae [NG],     using urine samples and swabs from the throat and rectum of men who have sex with men [MSM].     Using this test on these swabs is experimental because it has not been approved by the Food &     Drug Administration.   "
152226|NCT01291251|"     The guidelines of The Norwegian authorities concerning the use of antibiotics in general     practice state that for several common diseases such as pneumonia and tonsillitis,     antibiotics should be given four times daily instead of three times daily. The study´s aim is     to see whether the patient compliance is significantly reduced in antibiotic regimes of 3 or     4 daily doses as compared to 1 or 2 daily doses.   "
194145|NCT00387153|"     Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.   "
152227|NCT01291238|"     A whole of school intervention with daily physical activity and healthy food for students     with intellectual disabilities. The aim is to provide plenty of concrete examples of healthy     life style choices and using school personnel and peers as role models. This will presumably     result in healthier weight, better fitness and not least in new familiar healthy habits.   "
152228|NCT01291225|"     Specific Aim 1 - In collaboration with partners in Ross County, renovate and develop     playgrounds in Chillicothe.      Specific Aim 2 - In collaboration with partners in Ross County, promote safe play and play     areas for children on farms.   "
152229|NCT01291212|"     The investigators have previously demonstrated the utility of transdermal testosterone in in     vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the     efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating     hormone (FSHr) during ovarian stimulation in these patients.   "
152230|NCT01291199|"     The purpose of this study is to determine whether vardenafil is effective in improving     clinical symptoms and peripheral blood flow in patients with primary and secondary Raynaud     phenomenon.   "
152231|NCT01291186|"     The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal     anesthesia has not been well established. The investigators tried to quantify the effect of     BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine     between two different BMI groups.   "
152232|NCT01291173|"     To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe     binge eating disorder as measured by the number of binge days per week   "
152233|NCT01291160|"     This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12     weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of     Diabetic Foot Ulcer. The primary objectives of this study are: 1) to evaluate the     effectiveness of EPIFLO in combination with standard wound therapy on wound healing as     compared to standard wound therapy alone; and 2) Screening for potential safety issues.      Diabetic subjects with a Diabetic Foot Ulcer present for a minimum of 30 days will be     enrolled. All subjects enrolled in the study will receive a standard wound therapy regimen     consisting of, wound cleansing, moist wound care, off-loading and as appropriate, aggressive     debridement. Subjects will be randomized to either the Treatment arm or the Control arm.     Subjects will be assessed weekly for signs of wound healing during the 12-week Treatment     Period, once two weeks after wound closure and once at the end of 12-week durability Period.   "
152234|NCT01291147|"     More hysterectomies are performed laparoscopically either as a total laparoscopic     hysterectomy or as a laparoscopically assisted vaginal hysterectomy. The advantages of     laparoscopic surgery include quicker hospital discharge, a shorter convalescence and cost     effectiveness when compared to open procedures. Laparoscopic hysterectomies (both total and     vaginally assisted) can lead to discomfort which may lead to a delay in discharge from     hospital. Continuous infusions of local anaesthetic agents given post operatively to the site     of operation have the been subject of trials for several operative procedures. To date     however there have not been any properly controlled studies evaluating whether there are     benefits of giving a local anaesthetic infusion for 48 hours into the pelvis following a     total or vaginally assisted laparoscopic hysterectomy. The investigators therefore propose to     investigate whether giving a local anaesthetic infusion in this fashion decreases the amount     of rescue and patient controlled analgesia needed, and length of hospital stay. In order to     do this the investigators wish to conduct a randomised placebo controlled double blind trial.   "
152235|NCT01291134|"     The purpose of this study is to evaluate the rate and quality of spinal fusion utilizing     PureGen Osteoprogenitor Cell Allograft in Anterior Cervical Discectomy and Fusion (ACDF).   "
152236|NCT01291121|"     The main objective is to determine the efficacy of intravitreal administration of Ranibizumab     combined with intravitreous injection of expansile gas and induction of posterior vitreous     detachment on best-corrected visual acuity and ocular coherence tomography (OCT) macular     thickness in subjects with neovascular age-related macular degeneration (AMD) with posterior     vitreomacular adhesion (VMA).      Secondary objectives are to assess the safety and tolerability of the intravitreal     administration of Ranibizumab combined with intravitreous injection of expansile gas.   "
152237|NCT01291108|"     This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared     with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in     patients with primary open-angle glaucoma or ocular hypertension.   "
152238|NCT01291095|"     The aim of this trial is to compare the accelerated fractionation radiotherapy and concurrent     chemo-radiotherapy in locally advanced head and neck squamous cell carcinoma patients in     terms of loco-regional control, toxicities and quality of life.   "
152239|NCT01291082|"     Prospective MR-imaging study : role of magnetic resonance (MR) and Diffusion weighted imaging     (DWI) MR in staging and therapy assessment in breast cancer patients with bone metastases.   "
152240|NCT01291069|"     This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic     response to exercise and exercise capacity in patients with Fontan circulation. Data     regarding effect size and drug tolerability will be used in the design of a randomized     multicenter trial. The long-term goal of this investigation is to systematically evaluate the     effect of tadalafil therapy on exercise performance, quality of life, and delay of functional     deterioration in patients with single ventricle physiology.   "
152255|NCT01290874|"     We are doing this study to learn how genes affect the way that people, specifically Black     people, respond to treatment for asthma. Recent studies suggest that people respond     differently to some asthma medications (eg Serevent, Foradil). Some people feel better when     they use these inhalers, but others may not, and some people get worse. It seems that this     difference shows up more often in Blacks than in Whites, which is why we are looking for     Black subjects for this study. In all people, this difference seems to depend on their genes     or DNA. This study is comparing the use of long acting asthma medications (Serevent, Foradil)     to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat chronic     obstructive pulmonary disease (COPD). This study will help to see if this medication is also     useful for treating asthma and whether it works better for some people than the current     asthma medications.   "
153935|NCT01268930|"     In this study, impacts of hemostatic matrix and bipolar electrocoagulation on ovarian reserve     in women undergoing ovarian endometrioma excision are compared.   "
152241|NCT01291056|"     Clomiphene citrate is commonly used for ovulation induction in women with anovulation,     correction of luteal phase deficiency or for superovulation as empiric therapy for     unexplained infertility. Superovulation using clomiphene, usually with intrauterine     insemination, is usually regarded as first line therapy for unexplained infertility,     infertility due to mild endometriosis, or infertility with mild or moderate compromise of the     male factor. The side effect profile reported by some women using clomiphene citrate is     similar to symptoms of premenstrual dysphoric disorder (PMDD), including tension,     irritability, depressed mood, affective lability, lack of energy, difficulty concentrating,     and physical symptoms such as breast tenderness, bloating, headache joint and muscle pain.     Few studies have been performed to examine the relationship between clomiphene citrate and     mood symptoms; however, these studies have been limited by their small sample size, potential     for recall bias and lack of randomization. Moreover, the experience of infertility is     dysphoric in and of itself. Therefore, a rigorous evaluation of whether, when in the cycle,     and how often clomiphene is associated with mood changes is needed. Such a study would add to     the body of literature on this topic in three important ways: 1) use of prospective data     collection to more accurately identify commonly reported symptoms, 2) characterize the timing     of symptom occurrence relative to treatment cycle, and 3) provide information relevant to     planning of future studies involving targeted treatment of clomiphene citrate induced     symptoms. If clomiphene use is shown to affect mood, the results would point to an important     avenue for psychopharmacologic insight into relationships between mood and sex steroids.      OBJECTIVES:      Specific Aim #1: To identify psychological and physical symptoms experienced by women taking     clomiphene citrate for superovulation in a prospective, placebo controlled trial setting.      Specific Aim #2: To determine whether measures of the emotional and physical state prior to     the administration of clomiphene, predict the occurrence of mood changes during the five days     of clomiphene administration and in the late follicular and luteal phases of the cycle in     which clomiphene was administered.   "
152242|NCT01291043|"     Fibromyalgia is a syndrome characterized by chronic and generalized musculoskeletal pain and     tenderness in tender points. Its etiology and physiopathology are not well known; therefore     its treatment is not satisfactory. Having this in view, a search for alternative and     complementary medicine has been going on. This kind of practice is under pressure to present     evidences of efficacy. A randomized clinical trial will be carried out with the aim of     verifying the efficacy of a massage technique called Shiatsu in the improvement of pain,     flexibility, quality of sleep, anxiety and quality of life of individuals with fibromyalgia.     A sample of 34 subjects will be divided in Shiatsu Group and Control Group. All subjects will     be evaluated in the beginning, in the middle and at the end of the treatment. Pain will be     evaluated by the following instruments: visual analogue scale (VAS) and dolorimetry. The     V-sit and reach test (VSRT) will be used to assess the flexibility of the hamstring muscles     and lower back. The sleep will be evaluated with the Pittsburgh Sleep Quality Index (PSQI).     The State-Trait Anxiety Inventory (STAI) will be used to evaluate anxiety. The evaluation of     quality of life will be made with two instruments: fibromyalgia impact questionnaire (FIQ)     and Activities-specific Balance Confidence (ABC) scale. In each treatment session, the     subjects will be globally evaluated in the 14 main meridians and their respective points by     touch, identifying points of excessive energy and their severity. The Control Group will wait     for treatment and remain only with conventional pharmacological treatment, while the Shiatsu     Group will receive a treatment with Shiatsu during eight weeks. The results will be expressed     in mean and standard deviation. The normality of the data will be verified by the     Shapiro-Wilk test. In the intragroup analysis, the T-test for the parametric data and the     Wilcoxon test for the nonparametric data. In the comparison between groups, the analysis of     variance (ANOVA) test will be used. The level of significance adopted will be α < 0.05.   "
152243|NCT01291030|"     Hypomagnesemia is common in renal transplant recipients and is mainly because of enhanced     renal magnesium wasting, caused by immunosuppressive drugs (calcineurin inhibitors). Glucose     metabolism disorders, including insulin resistance and decreased insulin secretion, are also     prevalent post-transplantation and often precede the development of diabetes. As magnesium     supplementation has been demonstrated to increase insulin sensitivity in both diabetic and     non-diabetic patients, its potential therapeutic supplementation (post-transplantation)     deserves further examination. The hypothesis is that magnesium supplementation in renal     transplant recipients exerts a beneficial effect on insulin resistance and/or secretion.   "
152244|NCT01291017|"     The purpose of this study is to determine the efficacy and the toxicities of the study drug     PD0332991 in the treatment of patients with Stage IV non-small cell lung cancer with wildtype     retinoblastoma protein (RB) and inactivated cyclin dependent kinase (CDK) N2A in the tumor.   "
152245|NCT01291004|"     This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared     to two 28-day oral contraceptive regimens containing different synthetic progestins on     ovarian follicular activity and hormone levels in healthy women.   "
152246|NCT01290991|"     Is Augment Bone Graft plus Allograft safe to use for the treatment of osteochondral defects     of the knee?   "
152247|NCT01290978|"     The purpose of this study is to find out if presurgical antiseptic preparations affect how     well surgical drapes adhere to skin.   "
152248|NCT01290965|"     This study will examine the effectiveness of 15 days of therapy with SCY-635 in reducing     hepatitis C virus (HCV) RNA levels.   "
152249|NCT01290952|"     Compare completeness and modality of revascularization, operative and postoperative results     and 1 year clinical outcomes in unselected high risk patients referred for primary coronary     artery bypass surgery. Patients will be randomized to undergo off-pump coronary artery bypass     graft (OPCAB) or coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB).   "
152250|NCT01290939|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     lomustine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. It is not yet known which regimen of bevacizumab     given together with lomustine is most effective in treating patients with glioblastoma     multiforme in first recurrence.      PURPOSE: The primary objective of this study is to investigate whether the addition of     bevacizumab to lomustine improves overall survival (OS) in patients with recurrent     glioblastoma compared to treatment with lomustine alone.   "
152251|NCT01290926|"     Prospective non-randomized phase II study assessing the activity of the     Capecitabine-Sorafenib combination by estimating overall survival of the study population at     a fixed time point (6 months) and, as an exploratory analysis the overall survival of     metabolic responders versus non-responders.   "
152252|NCT01290913|"     This is a pilot feasibility study, using Xolair pretreatment for oral peanut desensitization.   "
152254|NCT01290887|"     The primary objective of the study is to evaluate the long-term safety of reslizumab at a     dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients     with eosinophilic asthma as assessed by adverse events, physical examination findings, vital     sign measurements, and concomitant medication usage throughout the study (every 4 weeks),     clinical laboratory test results, and measurement of antidrug antibodies.   "
157357|NCT01222416|"     The purpose of this study is to develop Positron Emission Tomography (PET) - Computed     Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast     cancer.   "
152399|NCT01289002|"     The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix     Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.   "
152256|NCT01290861|"     The overall objective of this study is to identify a 60 minute cognitive battery, for     subsequent use in clinical trials, that detects cognitive deficits in early HD and late     pre-manifest HD compared to controls, and that has a potential to show drug induced     improvements.   "
152257|NCT01290848|"     This project will evaluate the effectiveness of the Take TIME health promotion campaign. The     Take TIME (Tobacco free, Injury free, Moving daily, Eating healthy) campaign will target     parents and caregivers of children up to 8 years of age.      The study will help answer the following research questions        1. Are community organizations able and willing to deliver a health-promotion campaign          targeting young children?        2. What impact does the Take TIME campaign have on the readiness of the community to          support healthy childhoods?        3. What impact does the Take TIME campaign have on awareness and achievement of healthier          lifestyles for young children?        4. Can health promotion initiatives be institutionalized within the Municipality and          community organizations so that the campaign will continue beyond the study period?        5. Are changes in awareness and/or behaviour related to exposure to the Take TIME campaign?   "
152258|NCT01290835|"     The purpose of this study is to determine if it is feasible, safe, and effective to use     Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients     meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be     delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total     of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control     and site of failure (if any).   "
152259|NCT01290822|"     This study tests optimization of biventricular pacing (BiVP) in patients with dilated     cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in     patients with advanced cardiac failure. It examines the effects of atrioventricular delay     (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on     cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an     identical heart rate.   "
152260|NCT01290809|"     Stage III non-small cell lung cancer (NSCLC) patients constitute a significant proportion of     the lung cancer population. The prognosis of these patients has improved over the years due     the introduction of combined modality treatment, including high-dose chemo-radiotherapy. The     brain, however, remains one of the major sites of failure. Patients with brain metastasis     suffer from a variety of neurological, cognitive and emotional difficulties that are known to     adversely affect the health-related quality of life. Prophylactic Cranial Irradiation (PCI)     can prevent or delay the development of brain metastasis, and as such can improve     neurological disease-free survival and consequently health-related quality of life. But     survival is short, and toxicities are real, as PCI in itself can also induce adverse effects.     The cognitive adverse effects of PCI are not sufficiently illuminated and documented, due to     the lack of formal and systematic evaluation in patient populations expected to have short     survival. Also, recent attempts to reduce cognitive side effects of PCI by the application of     hippocampal-avoidance PCI in order to prevent memory deficits have not been fully evaluated     yet.      Before PCI can be offered routinely to stage III NSCLC patients in daily practice, the costs     and benefits of this therapy should be investigated properly, to allow for well-informed     treatment choices.   "
152261|NCT01290796|"     The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable     Single-Incision Sling in the surgical treatment of female stress urinary incontinence.   "
152262|NCT01290783|"     Trial design:        -  Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with Hyaluronic          acid-Irinotecan or HA-Irinotecan) regimen.        -  Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve.        -  Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria,          Poland, Serbia, Russia, Ukraine and the United Kingdom).        -  Dosing regimen:             -  Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in               patients > 75 years of age, the irinotecan and HA-Irinotecan dose in must be               reduced to 150 mg/m2).             -  Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with               irinotecan.             -  5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days               (total 2400 mg/m2 over 46-48 hours) continuous infusion.             -  Repeat every 2 weeks for 8 months.        -  Patient accrual over approximately 12-14 months.        -  Monitoring to 18 months post-randomization.        -  390 patients.        -  Progression Free Survival (PFS) primary endpoint.        -  Safety analysis on the initial 20 patients.   "
152275|NCT01290614|"     The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality     improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2)     adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based     quality improvement program for patients with CKD and assess potential mechanisms for the     intervention's effect.      Hypothesis: Implementing a CCM based quality improvement program including system level     support in the form of collaborative care, a CKD registry, and provider education will 1)     reduce systolic BP in patients with poorly controlled hypertension, 2) increase the     percentage of patients appropriately monitored for metabolic complications, and 3) decrease     the rate of catheter use in patients initiating dialysis.   "
152276|NCT01290601|"     This Phase II study is designed to determine whether a single 600 mg dose or 400mg/day for 3     days of tafenoquine is efficacious, and well tolerated for clearing P. vivax malaria     infection (blood schizontocidal and gametocytocidal activity) and preventing P. vivax relapse     (hypnozoite eradication). It will also further establish the safety and tolerability of these     doses of tafenoquine.   "
152279|NCT01290562|"     Patients with new or recurrent spine metastases are currently treated with low doses of     radiation delivered in up to ten treatments (wide-field radiation therapy). Stererotactic     body radiotherapy (SBRT) is a technique in which high doses of radiation targeted precisely     to the metastases to be treated are administered in a small number of sessions, thus reducing     the radiation damage to the surrounding tissue and areas of the spine.      The purpose of this study is to evaluate the efficacy of spine SBRT as an alternative to     conventional radiation for patients with no prior radiation, prior radiation, and in the     post-operative patient   "
152296|NCT01290341|"     This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group     Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the     treatment of tinea pedis.   "
152263|NCT01290770|"     Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries.     Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is     influenced by cardiovascular risk factors which obesity (Body Mass Index>30). Obesity is     associated with an increase risk of cardiovascular complications.      Lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular     disease. Lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein     molecule: apolipoprotein(a). Plasma levels are determinated to more than 90% by genetic     factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). Two     study with few patients have found that aspirin lowers serum Lp(a) levels. Elevated Lp(a) is     a risk factor for recurrent coronary events in obese patient.      Atherosclerosis is associated with imbalance of coagulation. TFPI (tissue factor pathway     inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct     inhibitor of tissue factor. In-vitro, TFPI activity is inhibited by high Lp(a) .      The aim of this study is to research reverse association between Lp(a) and TFPI activity in     obese patient with chest pain like stable angina suggesting atherosclerotic heart disease and     effect of aspirin.   "
152264|NCT01290757|"     The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of     dabigatran etexilate made from two different drug product batches.      The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved     capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using     a new capsule shell (Capsugel). The test batch is the drug product intended for future     commercial use.   "
152265|NCT01290744|"     This study is a double-blind, randomized controlled trial examining the effect on ENL     reactions of giving an additional year of clofazimine after completion of MDT in leprosy.   "
152266|NCT01290731|"     The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination     with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus     (HCV)-infected participants who relapsed after previous interferon (IFN)-based therapy in     Japan.   "
152267|NCT01290718|"     This single arm. open-label study will assess the efficacy and safety of Herceptin     (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or     recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with     Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14     of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle     followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease     progression or unacceptable toxicity occurs.   "
152268|NCT01290705|"     With this study two different therapeutic exercise regimens will be compared in patients with     anterior knee pain (patellofemoral pain syndrome, PFPS).   "
152269|NCT01290692|"     TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can     produce immune cells, called 'killer' white blood cells that have the ability to kill large     numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to     generate large numbers of those 'killer' white blood cells and to deliver those cells into     your body so that they can kill your cancer cells.   "
152270|NCT01290679|"     The purpose of this study is to investigate the effectiveness and safety of TMC435 compared     with placebo in participants who are infected with genotype 1 hepatitis C virus who have     never received treatment before. Participants will also receive peginterferon alfa-2a or     peginterferon alfa-2b and ribavirin as part of their treatment.   "
152271|NCT01290666|"     Primary outcome variable is healing at the final follow up visit.   "
152272|NCT01290653|"     This study investigates the effect of two different techniques (dry needling and     Strain-counterstrain manual technique) on the upper trapezius myofascial trigger point (MTP).     Subjects with active or latent MTP in this location of the muscle will be identified and will     be randomly assigned to one out of three groups: dry needling, strain-counterstrain or     placebo manual technique. Pain pressure threshold, provoked pain, pain at rest, neck     disability and electromyography (EMG) activity of the upper trapezius will be registered     before and after six sessions of treatment.   "
152273|NCT01290640|"     The objectives of this study are four-fold:        1. To determine the three-dimensional, in vivo kinematics for subjects having either a          fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis,          comparing the in vivo kinematics to determine if one implant type leads to a benefit for          the patient.        2. To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar          III Prosthesis under in vivo, weight-bearing conditions during multiple activities          (gait, stair descent, deep knee bend and chair rise).        3. To determine if there is a correlation between in vivo kinematic data obtained using          fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine          if variability occurs between these two TKA types.        4. To determine if a clinical benefit is either visibly detected (video camera) or          quantifiably determined (questionnaire) for either TKA type.   "
152274|NCT01290627|"     This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces)     of participants having a normal knee or a total knee arthroplasty (TKA) using one or two     different (TKA) devices Low Contract Stress (LCS) Posterior Stabilizing (PS) Rotating     Platform (RP) Total Knee Arthroplasty (TKA). All knees will be analyzed using an image     matching technique that will convert a two-dimensional (2D) fluoroscopic image into a     three-dimensional (3D) image. In conjunction with the fluoroscopic analysis, electromyography     (EMG) data, and ground reaction force (GRF) data will all be allow for a complete analysis of     the knee joints. These results will help the orthopaedic community better understand knee     motion so they can improve testing on existing implants and develop future implants that will     further enhance patients' lives.   "
152277|NCT01290588|"     The purpose of this study is to determine the effect of age and ethnic background on ocular     aqueous humor dynamics and biometric parameters. Data of normal healthy children and adults     will be used as controls for future study of juvenile glaucoma, and diabetes and potentially     for any other condition that affects intraocular pressure in children.   "
152278|NCT01290575|"     BMS-820132 is an investigational new drug being developed by BMS for treating Type 2     diabetes. The purpose of this study is to test the safety/tolerability (potential side     effects) of multiple doses of the investigational new drug, as well as the amount of study     drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.   "
152280|NCT01290549|"     This is a Phase I, multicenter, open-label, dose-escalation study of polatuzumab vedotin     administered as a single agent by intravenous (IV) infusion to participants with relapsed or     refractory hematologic malignancies. In Phase Ib, participants will receive polatuzumab     vedotin in combination with rituximab.   "
152281|NCT01290536|"     This is a prospective pilot study designed to document safety and efficacy of liver-directed     therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer     metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).   "
152282|NCT01290523|"     This is a prospective pilot study that will document the clinical experience of 30 patients     with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90     glass microspheres (TheraSphere®).   "
152283|NCT01290510|"     The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2%     hyaluronan) in the treatment of painful tendinopathy.   "
152284|NCT01290497|"     The main objective is the comparison of three different dosage regimens of hyaluronic acid in     the treatment of osteoarthritis of the knee.   "
152285|NCT01290484|"     There is an unsatisfied medical need for a first-line treatment of lymphatic malformations     with a good benefit/risk profile. Based on a patient experience in the institution, the     investigators plan to verify whether or not the medication sildenafil has a beneficial effect     on lymphatic malformations. The investigators plan to do this by treating patients with     lymphatic malformations with the medication sildenafil for a 20 week period. This is an     investigator initiated study funded by an Innovations in Patient Care grant and a SPARK     grant.   "
152286|NCT01290471|"     This is a Phase 1, open label study to assess the safety and tolerability of U3 1565,     determine maximum tolerated dose (MTD) or establish maximum administered dose (MAD) safety     and tolerability.   "
152287|NCT01290458|"     Consumption of vitamin supplements is a common practice among athletes or people     participating in health promoting exercise programs. The reason for this interest in vitamin     supplements is primarily because of the observation that enhanced production of reactive     oxygen and nitrogen species (RONS) influence fundamental biological processes, such as gene     expression, signal transduction and enzyme activity. In a muscle and exercise physiology     context, a low level of RONS is required for normal force production, whereas marked     increases in RONS can cause contractile dysfunction, resulting in muscle weakness and     fatigue. On the other hand RONS are involved in signaling pathways and serve to up-regulate     the expression of a number of genes and can exert favorable effects such as training     adaptations.      The present study will employ a valid eccentric exercise model to examine the influence of     combined vitamin C and E supplementation after acute and chronic eccentric exercise on muscle     damage and performance, redox status, hemolysis and lipid and lipoprotein profile.   "
152288|NCT01290445|"     A prospective population-based cohort study to examine whether varenicline use during     pregnancy is associated with an increased risk of major congenital malformations in infants     above that associated with smoking during pregnancy.   "
152289|NCT01290432|"     Dr. Roseff and his colleagues are conducting a study to evaluate the effectiveness of a novel     substance (Inofolic Plus®) in improving oocyte (egg) parameters in subfertile female     patients, as measured through Anti-Mullerian Hormone (AMH) blood levels.   "
152290|NCT01290419|"     A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to     Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in     healthy adults (18 to 49 years of age).      Study Objectives:      Primary:        -  To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein          particle vaccine formulations.      Secondary:        -  To assess and compare the immunogenicity (neutralizing antibody and total anti-F          antibody) of the 6 RSV-F protein particle vaccine formulations        -  To confirm the dose sparing and value added effects of the aluminum phosphate          adjuvant   "
152291|NCT01290406|"     This is an open label and single arm study to investigate the safety and efficacy of BEZ235     in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or     after first-line antineoplastic treatment for advanced endometrial carcinoma.   "
152292|NCT01290393|"     This study will assess the risk of spontaneous abortion during weeks 1-19 of gestation, and     other pregnancy outcomes, in an Exposed vaccinated cohort, i.e. women with last menstrual     period between 30 days before and 90 days after any dose of CERVARIX, when compared to a     Non-exposed vaccinated cohort, i.e. women with last menstrual period between 120 days and 18     months after the last CERVARIX or GARDASIL dose.   "
152293|NCT01290380|"     The purpose of this study is to evaluate the potential inhibitory effects of ASA404 on     CYP1A2, CYP2C9, CYP3A4 and CYP2C19 mediated metabolism on the respective probe drugs     caffeine, diclofenac, simvastatin, and omeprazole, respectively. This will be accomplished by     the simultaneous administration of four substrates as part of a cocktail in order to     characterize the potential for in-vivo drug-drug interactions. This cocktail approach has     been proposed per FDA guidance as a screening tool for potential in-vivo drug-drug     interactions Compared to the individual administration of specific probes in multiple     studies, simultaneous administration of multiple in-vivo probes of drug-metabolizing enzymes     offer several distinct advantages such as minimizing the confounding influence of     inter-individual and intra-individual variability over time. Substrates for the CYP enzymes     were chosen based on the FDA guidance recommendations taking into account that 1. The     substrates are specific for the individual CYP enzymes, 2. There are no interactions among     these substrates; and 3. The study will be conducted in a sufficient number of subjects.   "
152335|NCT01289834|"     The purpose of this scientific study is to compare early migration of hip prostheses in     respect to the bone in order to determine whether there is a clinical difference between the     two investigated bone cements (which one is best suited for cementation of hip prostheses).   "
152294|NCT01290367|"     The purpose of this study is to compare two doses of immunoselected, culture-expanded,     nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control     intradiscal injections in subjects with chronic low back pain due to moderate Degenerative     Disc Disease (DDD) at one lumbar level from L1 to S1.      All investigational subjects in this study will undergo injection of either 6 million (M) or     18M cells in a hyaluronic acid carrier into the degenerated lumbar disc's nucleus pulposus.     All control subjects will undergo an intradiscal control injection with either saline or     hyaluronic acid only   "
152297|NCT01290328|"     The primary purpose of this study is to determine the effect of Epoetin Alfa (Procrit) on the     change in hemoglobin (red blood cell count) in anemic kidney transplant recipients. The     investigators hypothesize that epoetin alfa will raise hemoglobin.   "
152298|NCT01290315|"     The purpose of this study is to compare safety and the oxidative stress potential of two     doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single     dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA)     in female subjects.   "
152299|NCT01290302|"     The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and     subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of     subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.   "
152300|NCT01290289|"     To compare combined spinal epidural, epidural and IV pethidine analgesia and their effects on     the mother, fetus, newborn and the course of labor.   "
152301|NCT01290276|"     The goals of this open-label Phase Ia study are to evaluate the Pharmacokinetics (PK)     profiles of new novel single-dose Ondansetron Pulsatile Release (Ond-PR) formulations in     normal healthy volunteers. After this initial phase, the investigators will follow with the     Phase Ib study to determine Pharmacokinetic/Pharmacodynamic (PK/PD), safety, and tolerability     interactions following simultaneous administration of these ondansetron formulations with a     10 mg Methylphenidate Immediate Release (MPh-IR) tablet in normal healthy volunteers.   "
152302|NCT01290263|"     Primary Objectives      Cohort A ‐‐ monotherapy:      To determine the efficacy of AMG 386 in participants with recurrent glioblastoma (GBM) as     measured by 6‐month progression‐free survival (PFS6)      Cohort B - combination therapy:      Phase I To determine the maximum tolerated dose of AMG 386 in combination with bevacizumab     given at 10mg/kg every 2 weeks in participants with recurrent glioblastoma.      Phase II To determine the efficacy of AMG 386 plus bevacizumab in participants with recurrent     glioblastoma (GBM) as measured by 6‐month progression‐free survival (PFS6).      Secondary Objectives:      To evaluate radiographic response in both cohort populations. To evaluate overall survival in     both cohort populations. To assess time‐to‐progression in both cohort populations. To     investigate the safety profile in both cohort populations.      Exploratory Objectives:      To evaluate expression of factors associated with tumor angiogenesis using a multiples     cytokine assay among participants undergoing therapy with AMG 386 with response to therapy     and development of resistance.      This is an open‐label Phase I/II study of AMG 386 monotherapy and AMG 386 in combination with     bevacizumab. Two cohorts will accrue and will be assessed sequentially. Each cohort will     enroll participants with recurrent GBM. Cohort A will assess recurrent GBM participants who     receive AMG 386 monotherapy at 30 g/kg every week. (Cohort A initially accrued at a dose of     15mg/kg, but this was increased to 30 mg/kg every week following an amendment). Cohort B will     assess recurrent GBM participants who receive weekly AMG 386 plus bi‐weekly bevacizumab     (10mg/kg). Cohort B will start with a Phase I component to determine the MTD of AMG 386 that     is safe when used in combination with bevacizumab. AMG 386 is administered intravenously,     and, when used in combination with intravenous bevacizumab, will be administered first.      Patients will be required to come to the clinic weekly for study drug administration.      For study purposes, a cycle of therapy will be 4 weeks. Treatment will continue until either     evidence of progressive disease, unacceptable toxicity, non‐compliance with study follow‐up,     or withdrawal of consent.      The estimated rate of accrual is 60 participants per year. The estimated date of accrual     completion is 1.5 years from study initiation. The estimated date of study completion will be     approximately 12 months from enrollment of the last study participant.   "
152303|NCT01290250|"     The purpose of this study is to evaluate the effects of a new orange juice-based beverage     enriched in fiber and selected phenolic compounds (mainly flavanones) on features of     metabolic syndrome and cardiovascular disease risk factors related to inflammation and     antioxidant defense system in overweight and obese adult humans. This study hypothesizes that     consumption of an orange juice-based beverage enriched in fiber and selected phenolic     compounds (mainly flavanones)would improve lipid levels and lipid metabolism,blood pressure     and the Homeostatic Model Assessment (HOMA) index.   "
152304|NCT01290237|"     Vancomycin is an antibiotic administered to children or adults for many types of infections.     While it has been used to treat infections of children for more than 50 years we are still     not completely certain about the best dose to use when starting treatment with this     medication.      This study is intended to evaluate whether giving a new higher dose of vancomycin for the     first dose will help us get to the desired amount in the body more quickly then the usual     first dose. Half of the patients would get the new higher dose and the other half of patients     will get the typical first dose. Only the first dose is changed and all doses that follow are     the same in both groups and are doses typically used for children.   "
152305|NCT01290224|"     RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by     chemotherapy.      PURPOSE: This phase II trial is studying how well MC5-A scrambler therapy works in reducing     peripheral neuropathy caused by chemotherapy   "
152306|NCT01290211|"     This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of     14 healthy male and/or female subjects, to estimate the effect of maraviroc on the     pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the     pharmacokinetics of maraviroc.   "
152307|NCT01290198|"     The objective of this proof of concept study is to assess the involvement of     epoxy-eicosatrienoic acids (EETs) in post-occlusive hyperemic and thermal hyperemia     responses, and the interaction between nitric oxide (NO) and EETs, using the latest methods     for the study of functional microcirculation.   "
152336|NCT01289821|"     This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when     given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with     metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an     oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets     certain key proteins that are essential for the survival of the cancer cell. By specifically     targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be     decreased by preventing these specific proteins from functioning.      The primary endpoint (the most meaningful result to be tracked) of this study is based on the     rate of response, i.e. the disease getting smaller. The aim is to show that the therapy of     colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response rate     observed for the standard therapy only.   "
152380|NCT01289249|"     The object of the study is to investigate whether all included patients receive treatment     that is effective against all bacteria that are defined as sensitive to meropenem with the     current treatment regimen. Will the investigators findings motivate routine monitoring of     plasma concentrations in children receiving meropenem? Up to 50 patients will be included in     the study, and all participants are children.   "
152381|NCT01289236|"     The purpose of this study is to compare the safety and efficacy of multiple doses of     Milnacipran to a placebo dose in subjects with Chronic Shoulder Pain.   "
152382|NCT01289223|"     To compare the efficacy of bendamustine against treatment of physician's choice on     progression-free survival in subjects with indolent B-cell NHL.   "
152400|NCT01288989|"     A dose escalation study to determine the safety and maximum tolerated dose (MTD) of IMC-3C5     in subjects with advanced solid tumors that are refractory to standard therapy or for which     no standard therapy is available.   "
152308|NCT01290185|"     Major orthopaedic surgery is painful and requires safe and effective postoperative analgesic     therapy. The successful use of continuous peripheral nerve blocks provides sustained     analgesia while minimizing the need for opioid analgesics throughout the postoperative period     and avoiding the side effects associated with central neuraxial techniques. Excellent     analgesia can be maintained and opioid-related side effects avoided allowing improved     rehabilitation. However using existing methods a failure rate of >20% significantly limits     the analgesic benefits in a substantial proportion leading to uncontrolled pain and side     effects of opioid analgesics.      A major concern with the use of continuous peripheral nerve blocks is difficulty in placement     of the catheters close enough to the nerve to allow for effective local anaesthetic spread     and therefore analgesia. The benefit of ultrasound to precisely place needles adjacent to     nerves and increase efficacy of block success is undisputed. However ultrasound is of less     help in accurately placing catheters. Indeed the final position of the catheter tip is not     predictable and can be inadequate in 10%-50% of cases. The explanation for that is the     material in currently used catheters is stiff and designed to avoid kinking. Unfortunately     this same stiffness often leads to inadequate placement of the catheter tip. We have     developed a catheter which coils up as soon as it is advanced beyond the needle tip, thus     allowing the catheter tip to remain close to the initial needle tip position and therefore     the nerve. The aim of this prospective randomized double blind controlled study is to     determine the effectiveness of this new catheter in comparison with standard of care methods     for continuous femoral nerve block commonly used after total knee arthroplasty. The primary     outcome measure will be the incidence of catheter related block failure 24 hours after     surgery. Our hypothesis is that the coiled catheter will significantly improve the efficacy     of continuous femoral nerve block as compared to existing techniques.   "
152309|NCT01290172|"     This study is a 5 day, single-center, randomized, double blind, placebo-controlled study to     evaluate the efficacy and safety of Somatostatin used as inflow modulator in liver     transplantation. Patient systemic and hepatic dynamics will be collected and recorded at     predefined time-points. To evaluate the ischemia-reperfusion injury, it is planned to perform     liver biopsies at two different time-points to compare the liver structure and proteomic     variations.   "
152310|NCT01290159|"     Today, the level of tolerance to heat is based on physiological strain indices, with no     correlates to any relevant biomarker. We hypothesize that oxidative stress (OS) and the     formation of reactive oxygen and nitrogen species (ROS, RNS), which are part of the underling     pathophysiology related to hyperthermia, can be used to identify tolerance/intolerance to     heat. The aim of the present project is to develop a simple assay, based on specific designed     sensitive biomarkers of OS that can be detected in a small blood sample, and to possibly     correlate each individual's state of tolerance to heat to the level of OS. These biomarkers     specially designed and synthesized to form a novel probe (not present as such in biological     organs). The method will be based on the incubation of the suggested biomarkers with the     patient's blood sample and the measurement of the level and type of oxidative alteration of     the markers. For this goal, post heat stroke patients, with different levels of tolerance to     heat and subjects during a process of acclimation to heat will be studied. Such a method will     add to our ability to better determine the level of tolerance to heat and not rely only on     the measurements of temperature and heart rate during an exercise-heat stress.   "
152311|NCT01290146|"     The purpose of this study is to compare in patients with Advanced Chronic Heart Failure the     effects of Levosimendan versus diuretic (single 24-hour infusion) applied at the early     detection of impending destabilization on hospitalization-free survival during 12 months.      Patients with advanced chronic heart failure (ACHF) have a short term reduced life expectancy     with recurrent hospital admissions for clinical exacerbations. Levosimendan improves     contractility by calcium-dependent binding to troponin C, determines vasodilation of the     coronary arteries and systemic resistance vessels, thus decreasing preload and afterload,     while exerting a protective effect on the myocardium against ischemia-reperfusion damage. In     randomized clinical trials of acute heart failure patients, levosimendan improved     hemodynamics and patients' quality of life and decreased natriuretic peptide plasma levels,     with no excess mortality The study will assess whether the administration of levosimendan     (single 24-hour infusion) at the early detection of deterioration may reduce frequency and     duration of hospital admissions, improve functional status and quality of life in ACHF     patients, with respect to diuretic infusion.   "
152312|NCT01290133|"     The purpose of this study is to describe the safety and tolerability and pharmacokinetics of     a single intravenous administration of the new, Sulfobutyl Ether-7-Beta-Cyclodextrin     (Captisol™) based, formulation in Healthy Adult Subjects.   "
152313|NCT01290120|"     The study was set up to assess the efficacy and tolerability of a chemotherapy-immunotherapy     combination programme originally introduced by GMALL (the German cooperative group for adult     acute lymphoblastic leukemia)in 2002, to improve remission rate, overall and disease-free     survival rates of adult patients with Burkitt's leukemia and lymphoma.      The therapy includes a maximum of six chemotherapy courses (two with high doses of     methotrexate and cytarabine) plus anti-CD20 antibody (Rituximab, up to 8 total doses),     supplemented by local radiation therapy in the case of initial mediastinal or central nervous     system (CNS) involvement or a residual tumor after chemotherapy.   "
152314|NCT01290107|"     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is looking at bone marrow samples from patients with acute     myeloid leukemia.   "
152315|NCT01290094|"     This single arm, open label study will assess the efficacy and safety of and compliance to     treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with     post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg     intravenously every three months. Anticipated time on study treatment is 12 months with a     follow-up of 12 months.   "
152316|NCT01290081|"     The purpose of this study was to determine the prevalence of latent tuberculosis infection     among injecting drug users and to conduct randomized controlled trial to evaluate a case     management intervention aimed at increasing TB screening and treatment entry among injecting     drug users referred from a methadone drug treatment program in Estonia.   "
152317|NCT01290068|"     The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR®     +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.   "
152337|NCT01289808|"     Glucose has analgesic and calming effects in newborns. To date, it is not known whether the     beneficial effects extend to care giving procedures that are performed after painful     procedures. The investigators objective is to determine the effect of glucose 25% analgesia     for procedural pain on infant pain responses during a subsequent care giving procedure.   "
152338|NCT01289795|"     The purpose of this study is to determine whether levels of circulating endothelial     progenitor cells (cEPC) are increased in the acute phase of ischemic stroke.   "
152318|NCT01290055|"     The yellow fever vaccine is a live, attenuated virus that results in a robust immune     response, especially in the T cell compartment. We have been studying immune responses to     live viral infections using the yellow fever vaccine as a model for a live viral infection.     In this study, we are interested in looking at the processing and lifespan of yellow fever     specific CD8 T cells.      We plan to accomplish this by measuring DNA replication and cell proliferation in humans     using a naturally occurring stable isotope called deuterium (D20). This technique has been     used to track the turnover of a number of human cell types in vivo. We plan to use D20     labeling to track YFV specific CD8+ T cells in human vaccinees who are positive for a     specific HLA type, HLA A202.      Deuterium labeled water (D2O), also known as heavy water is physically and chemically very     similar to ordinary drinking water. In water, two hydrogen atoms bond to an oxygen and create     H20. However in deuterated water, deuterium atoms replace the hydrogen atoms. Deuterium is a     form of hydrogen that has an extra neutron. This neutron gives the atom extra weight, hence     the name heavy water. This extra weight can be detected in the lab with very sensitive     instruments. Scientists have been using heavy water as a tracer to gain a better     understanding of animal and human metabolic rates. Deuterium is in fact already in the water     we drink daily. It is not radioactive, and it occurs naturally at a concentration of about 1     part per 5,000. Researchers have used heavy water since 1934 as a safe and effective tool in     clinical trials.   "
152319|NCT01290042|"     To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy     subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's     disease.   "
152320|NCT01290029|"     The primary objective of the study was to evaluate the safety and tolerability of cinacalcet     after a single oral dose in children aged 28 days to less than 6 years with chronic kidney     disease receiving dialysis.   "
152321|NCT01290016|"     Children who are overweight or obese can develop many health complications including     diabetes, high blood pressure, high cholesterol and they break their bones more often than     children who are of healthy body weights. Recent short-term studies in children suggest that     increasing milk intake for 16 weeks begins to improve body composition and also reduces risk     of developing diabetes. However, no study has been long enough to truly test for the benefits     of high milk consumption on these conditions including bone. Both dietary and activity     approaches to reducing obesity in children are suggested by health professionals and when     combined are called lifestyle interventions. Therefore, McGill University has designed a     1-year intervention study focused on lifestyle improvements to reduce obesity in children 6     to 12 years of age. A control group will be monitored for the year, while two other groups     will receive lifestyle interventions with standard recommended (2 servings a day) and high (4     servings a day) intakes of milk. The intervention will include 6 planning sessions to     increase intakes of vegetables, fruits and milks along with more activity and less time     watching television or using computerized games. Children will have muscle and fat measured     using an x-ray device that also measures bone at the beginning, middle and end of the study.     They will also have a small blood sample taken every 3 months to measure blood sugar,     cholesterol and some nutrients. Changes over the study will demonstrate the benefits of     lifestyle and milk interventions.   "
152322|NCT01290003|"     The purpose of the study is to evaluate the role of antibiotics in preventing infection in     babies born through meconium stained amniotic fluid. Normally babies do not pass meconium     while in utero. In response to hypoxic stress babies may pass meconium before birth and are     likely to be candidates for problems related to meconium passage and its inhalation. It is     believed that these babies are more prone to infections as meconium enhances bacterial growth     and may predispose such babies to secondary bacterial infections. In addition, meconium     passage has been incriminated as a pointer of in-utero infection. Whether use of antibiotics     in babies born through meconium stained amniotic fluid will reduce the infectious episodes     and complications thereof or not is not clear. Moreover, there is not much published     literature to prove or refute the same. Most clinicians have a low threshold for using     antibiotics in such babies. In view of the uncertainty regarding antibiotic usage in these     babies, the investigators decided to investigate the role of prophylactic antibiotics in     prevention of neonatal sepsis in babies born through meconium stained amniotic fluid.   "
152323|NCT01289990|"     This study will investigate the efficacy and long term safety and tolerability of BI 10773 in     type 2 diabetic patients.   "
152324|NCT01289977|"     Sand flies can carry the infection leishmaniasis (a parasite). The purpose of this study is     to evaluate the human immune response to uninfected laboratory raised sand fly bites and     select from the immune response to sand fly saliva, possible substances to use for a future     vaccine to protect against the parasite leishmaniasis.   "
152325|NCT01289964|"     The study aims to investigate the influence of 5 dry cupping treatments on chronic non     specific neck pain. 50 patients with neck pain are randomised into cupping treatment and     waiting list control group at T0 (Day 0). At T1 (Day 7)the investigators evaluate the neck     pain (VAS), the neck related disability (NDI), pain related to movement (PRTM) and the     quality of life (SF36). To investigate neurophysiological effects of cupping we also measure     mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain     threshold (PPT) at pain related and control areas. The treatment group then receives 5     cupping treatments over a period of two weeks. After the cupping series resp. a waiting     period for the waiting list control group (T2, Day 25) all measurements from T1 are repeated     (VAS, NDI, PRTM, SF36, MDT, PPT, VDT). At last, a pain and medication diary is filled in by     the patients from T0(Day 0) until T2 (Day 25). The investigators hypothesize, that cupping     treatment is effective against neck pain (diary, VAS, NDI, PRTM, SF36) and that it leads to     changes on perceptual level (MDT, VDT, PPT), when compared to the waiting list control group.   "
152339|NCT01289782|"     The purpose of this study is to investigate the effectiveness and safety of TMC435 compared     with placebo in participants who are infected with genotype 1 hepatitis C virus who have     never received treatment before. Participants will also receive peginterferon alpha-2a and     ribavirin as part of their treatment.   "
152340|NCT01289769|"     The purpose of this study is to evaluate the effect of dexmedetomidine on hemodynamic     responses during laryngoscopy and double lumen endotracheal intubation and assess the adverse     effect related to complications of dexmedetomidine.   "
195438|NCT00405613|"     The purpose of this study is to determine if aspirin is associated with bleeding     complications following a single tooth extraction   "
152326|NCT01289951|"     Raltegravir is the first integrase inhibitor used in humans. It has been shown to be highly     efficacious and well tolerated in phase III clinical trials in multidrug experienced human     immunodeficiency virus(HIV)-infected patients, as well as initial therapy in untreated     patients. Pharmacokinetic studies in healthy adult subjects indicate that the major mechanism     of clearance of the drug is glucuronidation mediated by UGT1A1, with a minor contribution of     renal excretion of unchanged parent compound. Unlike CYP-based metabolism, glucuronidation is     generally found to be relatively unaffected by hepatic disease. A single dose pharmacokinetic     study of raltegravir in patients with mild to moderate hepatic insufficiency (Steigbigel et     al. 2008) found no clinically important effect on the drug pharmacokinetic profile, with no     dosage adjustment being necessary. The liver safety and tolerability of boosted atazanavir     (ATV/r) has been evaluated in human immunodeficiency virus and hepatitis C virus (HIV/HCV)     coinfected patients with advanced liver disease (decompensated cirrhosis) (Hermida JM et al.     4th IAS: Sidney, 2007). Similar to Raltegravir, ATV is also mainly metabolized by conjugation     through UGT1A1. There is an urgent need for potent and efficacious ARV drugs with a clean     safety liver profile even in patients with severe liver disease. The investigators     hypothesized that pharmacokinetics will not be altered in HIV/HCV patients with advanced     (Child-Pugh grade C) cirrhosis or in those with no histologic liver damage.   "
152327|NCT01289938|"     Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and     Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to     polymorphisms of CYP2D6   "
152328|NCT01289925|"     Serum levels of inflammatory mediators increase with age and are strongly associated with the     most common and the most devastating health conditions found in older adults including     frailty, chronic disease, disability and increased mortality. Even though the processes that     contribute to increased inflammatory mediators are likely not completely reversible in older     adults, the development of a safe and effective intervention that modulates inappropriate     inflammatory responses could be a very important component of prevention against frailty and     other adverse health outcomes. As part of an ongoing effort to identify molecular and     physiologic triggers of inflammation in older adults, the investigators recently identified a     highly significant inverse relationship between the anti-oxidant micronutrient selenium and     the inflammatory mediator IL-6, as well as a significant relationship between selenium and     all cause mortality in a population of community dwelling older women with selenium levels     well below the mean for the overall American population. Based on our findings in older     adults and on data from other studies that suggest that selenium interventions are effective     in targeted populations with inflammatory conditions, the investigators hypothesize that     selenium supplementation targeted to a population of older adults with increased inflammatory     markers and low normal selenium levels will in the short term reduce inflammation as measured     by serum IL-6, and in the long term will reduce the incidence and prevalence of inflammation     associated poor health outcomes of frailty, disability, and mortality in vulnerable older     adults.   "
152329|NCT01289912|"     Tuberous Sclerosis Complex (TSC) is a multi-system disease, usually presenting with seizures,     mental retardation and autism, and exhibiting a high variability in clinical findings both     among and within families. Investigators are doing research in order to identify possible     neurocognitive benefits from treatment with RAD001 or placebo for a six month period. There     may also be potential for improvements in seizure frequency, sleep and autistic behaviors. We     hope this trial will lead to a better understanding of TSC and to new forms of treatment, to     benefit children and adults with TSC in the future.      Individuals diagnosed with TSC will be asked to participate in this study if they are between     the ages of 6 and 21 years of age and have an IQ of greater than or equal to 60. Both males     and females will be asked to participate. Additionally, to be eligible for study     participation, individuals must have been on the same seizure medication(s), if applicable,     for at least 6 months. Individuals must also be able to participate in neuropsychological     testing and meet certain medical criteria. They will need to sign an informed consent. If     enrolled in the study, participants will have a number of screening tests to help determine     if they are eligible for participation in the clinical trial. If eligible for the treatment     phase of the trial, they will be asked to take either the study drug or a placebo (pill with     no medicine), which is determined by chance.      The study involves about 9 visits, 3 of which can be done locally, over a six month period,     as well as follow-up calls with our research nurse. Study visits will vary in length.     Screening, three month and six month visits may last up to 8 hours, while all other visits     will be less than 2 hours. The study visits include blood draws, laboratory tests and     neuropsychological assessments. There is no fee to participate in this study. Some     compensation may be available for travel costs of out-of-state participants based on fund     availability. The study drug will be provided at no charge during the study.      After all study data has been analyzed, families will be informed of the overall results.     Treatment on this study may or may not improve a child's learning skills (neurocognition).     Future patients may benefit from what is learned.   "
152330|NCT01289899|"     The objective of this study is to determine the safety and tolerability and to determine the     Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in     healthy male subjects.   "
152331|NCT01289886|"     The objective of this study is to determine the safety and tolerability and to determine the     Pharmacokinetic and Pharmacodynamic (PK/PD) of ascending single oral dose of BR-A-657 in     healthy male subjects.   "
152332|NCT01289873|"     The purpose of this study is to determine how common oral HPV infections are in college     women. The investigators also will find out what risk factors are associated with having oral     HPV infections. The investigators hypothesize that approximately 3% of women will have oral     HPV, and that HPV will be associated with oral sexual behaviors and with smoking behaviors.     Finally, for those women with oral HPV- the investigators will determine whether the     infections are persistent (still present) at 3-, 6-, and 12-months after the initial     diagnosis.   "
152333|NCT01289860|"     This study was a controlled, cross-over, acute flavonoid intervention trial with younger and     older adults. Subjects consumed a blueberry beverage during one visit and a control beverage     on another. Cognitive function pre drink was assessed, blood and urine samples were taken as     well as blood pressure and a measure of vascular reactivity. These outcome measures were     taken at 2 and 5 hours post drink.      It was predicted that the flavonoids in the blueberry drink would lead to improved     performance on the cognitive tests and vascular reactivity measure compared to following the     control drink. It was thought this could be due to increased vaso-dilation and improving     blood flow to the brain which was investigated in an extension to the project where a sample     of individuals underwent brain imaging in an MRI scanner pre and post a blueberry and a     control drink.   "
152334|NCT01289847|"     The main objective is to determine the efficacy of Gammaplex by measuring the number of     serious acute bacterial infections during treatment with Gammaplex over a 12 month period.     The secondary objectives are to assess the safety and tolerability of Gammaplex and to     compare the data collected from adult subjects with PID from the GMX01 study   "
152345|NCT01289704|"     Charcot−Marie−Tooth neuropathy type 1A (CMT1A) is one of the most common inherited     neurological disorders. The study will evaluate the efficacy and safety of an innovative     rehabilitation protocol constituted by exercises at the treadmill and by a stretching and     proprioceptive approach. A total of 92 patients will be enrolled in the study and treated in     a controlled, randomized, single blind, way. To recruit a high number of patients with CMT1A     the study will be multicentric and will comprehend four of the most active clinical centers     in the field of CMT, in Italy. People with CMT1A are very motivated in entering     rehabilitation protocols because to date there is no effective therapy for this disease.     Therefore, the investigators expect a high compliance by the patients. With the present     project the investigators plan to clarify several unanswered questions: 1) the efficacy and     safety of treadmill over a more conventional protocol; 2) the duration and frequency of any     rehabilitation treatment; 3) the most sensitive outcome measures to evaluate the efficacy of     rehabilitation approach in patients with CMT.   "
152346|NCT01289691|"     Patients scheduled for lung lobe resection using video assisted thoracic surgery will be     randomly assigned to be ventilated with either only oxygen or a mixture of air and oxygen.      The primary purpose of this study is to determine if the incidence of postoperative collapse     (in the non-surgical lung) is decreased when using a mixture of air and oxygen compared to     using only oxygen (which is our control measurement) during one-lung ventilation.   "
152347|NCT01289678|"     Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment     during lymphocyte recovery.   "
152348|NCT01289665|"     The purpose of this study is to determine if lubricating gel affects patients' perception of     discomfort during speculum insertion, as compared to water.   "
152349|NCT01289652|"     The aim of the study is to investigate the epidemiology, natural history and treatment     outcomes of acute hepatitis C (HCV) infection. Given the current pattern of case reporting,     the cohort will be largely made up of human immunodeficiency virus (HIV)-positive patients,     but HIV-negative patients with acute hepatitis C (AHC) will also be enrolled to enable     comparisons to be made as appropriate and possible.   "
152350|NCT01289639|"     The study is designed to investigate the relationship between insulin resistance and     non-alcoholic fatty liver disease (NAFLD) and to investigate potential mechanisms underlying     insulin resistance in NAFLD by determining associations between hepatic and peripheral     insulin sensitivity, hepatic steatosis, dyslipidemia, inflammatory cytokines, glucose     metabolism, beta-cell function and body fat distribution.   "
152351|NCT01289626|"     The research question and primary aim is to determine if lanthanum carbonate is effective in     treating calciphylaxis by measurement of complete or partial remission of skin lesions.     Secondary endpoints will be measured to determine if lanthanum carbonate can lower     calcium-phosphorus product levels, intact PTH and mortality. Albumin levels will be measured     as a marker of nutritional status and inflammation.   "
152352|NCT01289613|"     BIS for monitoring depth of anesthesia is usually obtained unilaterally. Obtaining BIS     bilaterally revealed side differences in previous studies. This study investigates the     incidence of clinically relevant side differences of BIS during maintenance and emergence     from anesthesia for ENT surgery in both adults and children.   "
152353|NCT01289600|"     The purpose of this study is to demonstrate that mechanical ventilation guided by the     diaphragm EMG signal (also know as neurally adjusted ventilatory assist [NAVA]) is superior     compared to pressure support and pressure control ventilation.   "
152354|NCT01289587|"     The aim of this study is to evaluate the effects of a physical activity intervention in     patients with type 2 diabetes in a community setting.   "
152355|NCT01289574|"     To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice     daily for facial acne compared to vehicle control.   "
152356|NCT01289561|"     The purpose of this study is to investigate the effects of caffeine on the     self-administration of alcohol. The study will also examine the combined effects of alcohol     and caffeine on behavioral performance, participant ratings of behavioral performance, and     self-reported subjective effects.   "
152357|NCT01289548|"     The purpose of this study was to investigate whether lower limb ischaemic preconditioning can     improve renal function in patients undergoing living donor kidney transplantation   "
152358|NCT01289535|"     This study is the first step in a clinical research program that aims to study the immune     response to influenza vaccine in the elderly and then to propose a new method of     administering the vaccine.      Influenza can cause severe complications in patients at risk (elderly and subjects vulnerable     because of a chronic underlying disease). Over 90% of deaths related to influenza occur in     people aged over 65 years.      Vaccination is the most effective way to prevent infection. The World Health Organization     recommends annual immunization for people at risk, including all persons aged over 65 years,     to reduce the risk of morbidity and mortality related to influenza.      However, the immune response to influenza vaccine appears to be lower in elderly than in     young people.   "
152359|NCT01289522|"     PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line     treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas.     Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck     cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination     named TPEx as first-line treatment in this setting.   "
152360|NCT01289509|"     The purpose of this study is to evaluate the relative bioavailability (BA) of two lots of     E5501 40 mg tablets administered twice as single oral doses to healthy subjects.   "
152361|NCT01289496|"     Patients for whom treatment with peginterferon plus ribavirin was unsuccessful represent a     category of patients for whom there is currently no worthwhile therapeutic alternative.      Several studies have shown that there is a relation between plasma ribavirin concentrations     and treatment response. Adequate ribavirin plasma concentrations, especially during the first     12 weeks of treatment, should be associated with a better chance of response to the     treatment.      The strategy for this study will be to use a loading dose of ribavirin before beginning the     treatment with peg-interferon, thereby allowing for optimal ribavirin concentrations to be     reached, and possibly improving the effectiveness of the treatment.   "
157358|NCT01224145|"     This study will assess pain intensity for the first 72 hrs after aggravated movement (cough)     following Laparoscopic Inguinal or Umbilical Herniorrhaphy.   "
152362|NCT01289483|"     Patients scheduled for awake fiberoptic intubation (AFI) because of potential difficult     airway will be consented prior to intubation ASA Physical Status classification and history     of difficult intubation will be recorded at screening. The investigators will also record the     results of airway examination including Mallampati classification, thyromental distance,     mouth opening, neck circumference, neck range of motion, presence or absence of beard and     overbite, history of neck radiation, and mandibular protrusion test Informed consent will be     obtained prior to the procedure from those patients who meet the inclusion and exclusion     criteria.      Standard hemodynamic monitoring will be used in all patients including EKG, blood pressure,     heart rate, respiratory rate and oxygen saturation. Modified Observer's Assessment of     Alertness/Sedation (MOAA/S) scale will be used to assess the level of alertness/sedation. Two     consecutive MOAA/S scores of 4 will be considered as the desired effect of moderate sedation.      For AFI procedure, IV will be started and oxygen will be administered. 4 L of oxygen will be     delivered through nasal canula until the completion of the AFI procedure. Patient head will     be positioned in the sniffing position, Topical anesthesia would be achieved using the     topical administration of 4 percent lidocaine using atomized and MaDgic nebulizer, and 2%     xylocaine Jel applied to the surface of Williams airway in a total dose of lidocaine not     exceeding 10 mg/kg. Patients will be randomized to one of the four fospropofol treatment     arms: 2, 3.5, 5, or 6.5 mg/kg   "
152363|NCT01289470|"     An observational study designed to evaluate the performance of a new Near Infrared     Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral     sensor and peripheral sensor. Fifty patients who are undergoing open-heart surgery will be     enrolled and tissue oximetry measurement will be collected throughout the surgical procedure     and for up to 24 hours following surgery. Tissue oximeter measurement of the brain and     skeletal tissue will be added to the standard intra-operative patient monitoring. Measures of     delirium will be collected using a standardized questionnaire. The relationship between     cerebral oximetry measures and delirium scores will be explored.   "
152364|NCT01289457|"     The goal of this clinical research study is to learn if the combination of clofarabine,     idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can     help control AML and MDS. The safety of these study drug combinations will also be studied.   "
152366|NCT01289431|"     The objective of this study is to evaluate the dose response, and efficacy of Mapracorat     ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs     associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.   "
152367|NCT01289418|"     Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or     drifts, and its safety profile may vary. While generally considered safe, influenza vaccines     have been associated in the past with increases in cases of Guillain-Barré syndrome (1976) or     with oculorespiratory syndrome (2001). The emergence of a novel strain of H1N1 influenza     virus (pH1N1) has prompted health departments worldwide to prepare for mass vaccination     campaigns with a new H1N1 pandemic vaccine. Following recommendations of the World Health     Organization (WHO), Canada immunized its population with a dose-sparing adjuvanted vaccine.     While the adjuvant developed by GlaxoSmithKline (GSK) has been administered to over 39 000     people, only a few hundred will have been vaccinated with the H1N1 formulation in clinical     trials before the mass campaign was launched. With this small number, adverse events     occurring at a rate < 1% will not be detected by these clinical trials.      Considering that most cases of pH1N1 to date have been relatively mild, it will be imperative     to rapidly detect adverse events serious enough to reconsider the use of the vaccine. Passive     surveillance is collecting notifications of adverse events but the sensitivity of this system     is not high and its timeliness is not necessarily optimal.      In Canada, healthcare workers (HCW) are among those who were offered the new pandemic vaccine     in priority. Because they were offered the vaccine early in the campaign and because they     constitute a well-defined group in good general health, this group of people may be well     suited for monitoring the safety of the pH1N1 vaccine.      The main objective of this project was to estimate in HCW vaccinated against pH1N1 the     frequency of adverse events of sufficient severity to cause work absenteeism or medical     consultation.      The active surveillance was done in HCW from 3 sites (Canadian hospitals) participating in     the Pandemic Influenza Research Network (PCIRN): (1) Halifax (Nova Scotia), (2) Quebec City     (Quebec): 3 hospitals, (3) Toronto   "
152378|NCT01289275|"     When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of     them, however, go back to smoking soon after discharge. This study will test an innovative     approach which includes dispensing nicotine patches at discharge, providing proactive     telephone counseling post discharge, or giving a combination of the two. The interventions     are aimed at increasing the long term quit rate of these patients.      The specific aims of the study are to demonstrate the effects of two interventions,     dispensing nicotine patches at discharge and providing proactive telephone counseling soon     after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.   "
152379|NCT01289262|"     Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology     Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S     (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in     subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies,     ...) are very important issues. Classically Kerr incision is repaired with continuous locked     suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in     turn may reduce short and long term complications. For this reason, the investigators aimed     to compare two closure techniques.   "
195439|NCT00405626|"     To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis     Perenis and Arnica montana   "
152383|NCT01289210|"     This study is to determine the safety and effectiveness of VTX-2337 (an investigational drug     that stimulates the immune system) in combination with radiation therapy in treating patients     with low-grade B-cell lymphoma. Patients will receive 2 low doses of radiotherapy, and 9     intratumoral injections of VTX-2337 over the course of 3 months.   "
152396|NCT01289041|"     This is a prospective multi-center, open-label, single arm, Phase II study to investigate the     safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease     progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120     orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a     fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase     (PI3K) pathway activation status.   "
152397|NCT01289028|"     This study will evaluate the preliminary efficacy of nilotinib in pretreated patients     (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.   "
152398|NCT01289015|"     The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once     daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with     tinea pedis.   "
152368|NCT01289405|"     Objective: to evaluate the effects of a speech therapy exercises program in the treatment of     Obstructive Sleep Apna Syndrome (OSAS) patients based on the clinical and polysomnography     (PSG) parameters.      Methods: 80 patients with OSAS will be evaluated: men, 25-65 years old, body mass index < 35     kg/m2 and scores of Epworth Sleepiness Scale > 9. Patients will be divided into four groups:     I: 20 patients with OSAS underwent speech therapy; II: 20 patients with OSAS underwent     placebo therapy of Speech Therapy; III: 20 patients starting treatment with CPAP underwent     speech therapy; IV: 20 patients starting treatment with CPAP without speech therapy or     placebo. The speech therapy include isometric and isotonic exercises to improve posture,     mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of     tongue, cheeks and lips. Placebo therapy includes relaxation exercises and stretching neck,     without therapeutic purpose. Both therapies are applied for three months, three times a day,     lasting 20 minutes each session. During the treatment, the subjects will be monitored in     weekly meetings, for orientation and description of the exercises and return of the fulfilled     exercises diary. The subjects will also be followed at the CPAP clinic in returns after one     week, a month and at the end of the study. Conduct assessments before and after treatment and     after twenty one days washout, including: assessing the upper airway, anthropometric     investigation of the facial skeleton and speech of Orofacial, questionnaires (Epworth     Sleepiness Scale, FOSQ, General Segment and use of CPAP, WHOQOL-BREF, snoring), Psychomotor     Vigilance Test and PSG.   "
152369|NCT01289392|"     Introduction: It is unclear whether exercise training with or without Continuous Positive     Airway Pressure (CPAP) and Oral Appliance (OA) is more effective in reducing symptoms of     Obstructive Sleep Apnea (OSA) than treatment solely with CPAP or OA.      Objective: In patients with moderate OSA, the investigators will evaluate the effect on the     subjective and objective measures of sleep, quality of life and mood of different forms of     treatment: exercise training of 4 months; exercise training of 4 months associated with CPAP     and OA; treatment with CPAP and treatment with OA.      Material and Methods: Sixty male patients (25-65 years, sedentary lifestyle, Body Mass Index     (BMI) < 35kg/m2, Apnea-Hypopnea Index (AHI) between 15-30/h, Epworth sleepiness scale > 9)     will be divided into three groups: CPAP+exercise group (CE; n=20), OA+exercise group (AE;     n=20), and Exercise training group (E; n=20). The patients in groups CE and AE will complete     two months of treatment with CPAP or OA to examine the separate effects of these devices. As     the patients of the E group did not use the CPAP but will undergo four months of exercise     training. After this initial step, patients in CE and AE groups will undergo four months of     exercise training associated with CPAP or OA. The investigators will evaluate the subjective     sleep parameters (sleep disorders questionnaire, the Epworth Sleepiness Scale, sleep diaries)     and objective (polysomnography), Short Form Health Survey (SF-36), Questionnaire Profile of     Mood States (POMS) and anthropometric measurements (neck circumference and body composition),     the incremental exercise test (ergospirometry) and the one Repetition Maximum test (1RM).   "
152370|NCT01289379|"     Investigators conducted a randomised perspective study to determine whether the use of HFJV     instead of conventional mechanical ventilation will reduce the adverse cardiovascular effects     of pneumoperitoneum during laparoscopic surgery.   "
152371|NCT01289366|"     Precise activity assessment of inflammatory bowel disease (IBD) is essential to determine the     extent and severity of the disease for further specific therapy. Nevertheless, despite     ongoing developments in the field of gastrointestinal endoscopy, the final diagnosis still     relies on the interpretation of histopathological features of intestinal biopsies taken     during the endoscopic examination. Recently, endocytoscopy (EC) was introduced as a new     endoscopic imaging modality, enabling microscopic imaging within the mucosal layer of the gut     at a magnification level of up to 1400-fold.   "
152372|NCT01289353|"     The purpose of this study is to determine the safety and effectiveness of a combination of     chemotherapy and radiotherapy in breast cancer patients after breast surgery.   "
152373|NCT01289340|"     the aim of the study is to compare between two advanced wound dressing and conventional     dressing for the primary ER treatment of superficial partial thickness burns   "
152374|NCT01289327|"     Although propofol is a popular agent for sedation during flexible bronchoscopy, some     clinicians have raised concerns that it may cause greater respiratory drive reduction than     more common drugs. However, this factor is difficult to accurately examine with pulse     oximetry. The introduction of a novel device that noninvasively measures carbon dioxide (CO2)     levels can help to resolve this controversy. The aim of this study is to evaluate the safety     of conscious sedation with midazolam+alfentanil compared to propofol.   "
152375|NCT01289314|"     Objective: To compare the occurrence and intensity of pelvic pain as well as patient     satisfaction and quality of life after total laparoscopic and laparoscopic supracervical     hysterectomy.      Design: Prospective randomised trial.      Null hypothesis 1: There is no significant difference in occurrence and intensity of pelvic     pain following TLH compared with following LSH.      Null hypothesis 2: There is no significant difference in patient satisfaction and quality of     life following TLH compared with following LSH.   "
152376|NCT01289301|"     Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to     graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study     the best way to manage viral invasion by changing the immunosuppressive treatment comparing     two treatment schemes. The investigators hypothesis is that switching to an mTOR-based scheme     is superior to a general decrease of a calcineurin inhibitor (CNI)-based scheme. The study     will be performed as a prospective, randomized, parallel group comparison.   "
152377|NCT01289288|"     The objective of this study is to test whether a culturally-tailored in-office based     intervention have impact on increasing Chinese physician's recommendation of colorectal     cancer (CRC) screening to their nonadherent Chinese patients.      Special aims are to:        1. Evaluate the efficacy of a culturally-tailored physician intervention on increasing          non-adherent Chinese American's patients' CRC screening rate.        2. Identify factors that mediate or moderate the intervention effects. For example,          patients who hold an eastern cultural view or are less acculturated will be more likely          to benefit from the intervention than patients who hold a western view or who are more          acculturated.   "
153586|NCT01273467|"     The purpose of this study is to evaluate the safety and tolerability of 42037788 (CNTO 0007)     in patients who have suffered a stroke. The study is not designed to establish efficacy,     although preliminary explorations will be conducted.   "
152384|NCT01289197|"     The primary goal of this project is to examine the short and long-term effects of an     intervention focusing on three interrelated dimensions of health: improving sleep, increasing     physical activity, and improving skills in emotion regulation. This intervention targets     high-risk youth at a key neuromaturational period—early adolescence—when many individuals are     experiencing new challenges to regulatory systems involved in sleep, activity, and emotion     regulation. This maturational period is also a crucial time in the normal development of     habits, skills, and proclivities in each of these domains. Thus, early adolescence presents     unique opportunities for intervention targeting these three interrelated regulatory systems.     Participants will include 200 9-13 year-old children who are siblings of children enrolled in     one of three ongoing studies of vulnerability and resilience, whose families were initially     identified on the basis of sociodemographic, child, and/or family risk or are recruited thru     local Family Centers. Children will be selected as having difficulties in at least one of     these domains (sleep, sedentary behavior, or emotion regulation) and then randomly assigned     to either a control or intervention group. All families will receive baseline, one- and     two-year follow-up assessments of child sleep, physical activity, and emotion regulation.     Families in the intervention group will have the opportunity to receive feedback and     intervention services on these three child domains and other parenting and family issues     (e.g., parent involvement, parent self-care, school problems) following the initial     assessment and the one-year follow up. The intervention will involve the parent and target     youth receiving feedback about the child's current status in these areas and family     functioning. If desired, the family will also participate in follow-up meetings with the     parent and/or target youth to improve the youth's sleep, physical activity, and/or emotion     regulation skills, as well as aspects of the family environment. The investigators     hypothesize that the intervention will be associated with improvements in sleep, physical     activity, and emotion regulation among those in the intervention group, as well as     improvements in measures of social, behavioral, and affective function. Finally, the     investigators will explore the possibility that increases in parental involvement mediate     some of the changes found in child sleep, physical activity, and emotion regulation.   "
152385|NCT01289184|"     To monitor air quality in selected photocopier units and to assess the health status of     workers who are exposed to emissions from photocopiers.   "
152386|NCT01289171|"     Many human immunodeficiency virus (HIV)-positive children are afflicted with diffuse flat     warts that have been recalcitrant to multiple treatments.The aim of this prospective study     was to evaluate the efficacy, safety and tolerability of 15% glycolic acid lotion (NeoStrata)     for treatment of flat warts in HIV-positive children in Botswana. Additionally, the     investigators characterized the flat warts in this population, including Human Papillomavirus     (HPV) type(s) and degree of immunosuppression within the patients.   "
152387|NCT01289158|"     The investigators are interested in learning more about the changes found in the condition     called Combined elevation of Malonic and MethylMalonic Acid, or CMAMMA.  Malonic, or MA and     MethylMalonic, or MMA, are acids formed from the breakdown of protein under normal     conditions. However, in the condition called CMAMMA there is an increase of these acids in     the blood and urine, which is not normal.      Some people with high MA and MMA in their blood and urine have a serious disease, starting as     a baby or young child that includes heart disease and problems in learning. These people have     changes in a special enzyme called Malonyl CoA Decarboxylase (MCD). Other people who have a     high level of MA and MMA do not have any obvious illness. The investigators are not sure why     they have high levels of MA and MMA and why they are not sick.      The goal of this study is to learn more about why some people have a high level of MA and MMA     and to make sure there are no medical problems as a result of these high levels. The     investigators also want to find out which gene and enzyme cause the high levels of MA and     MMA.   "
152388|NCT01289145|"     The purpose of this study is to increase regular physical activity among students by     fostering self-management competencies. The intervention was implemented as paper-pencil     intervention. The aim of this research project is to evaluate a motivational and volitional     intervention in comparison to a control intervention.      Study participants will be recruited in lectures at Freie Universitaet Berlin and followed up     twice (two and ten weeks after baseline).      The motivational intervention is expected to increase unmotivated participants' intention to     be physically active. The volitional intervention is expected to promote physical activity     among motivated but inactive participants. Both interventions are hypothesized to improve     self-management competencies over time.   "
152389|NCT01289132|"     The purpose of this study was to evaluate the dose-response relationships of azilsartan, once     daily (QD) in participants with mild to moderate uncomplicated essential hypertension.   "
152390|NCT01289119|"     The purpose of the study is to determine the efficacy of alogliptin compared to placebo when     given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without     metformin).   "
152391|NCT01289106|"     The purposes of this study include 1) to compare the seroconversion rate of an intensive     standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months),     and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2     and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in     HIV-infected adult patients.   "
152392|NCT01289093|"     LIFE-IN. Quality of life after operation for hernias are not well investigated and lack a     good and easy-to-understand-tool to measure it. Carolina Comfort Scale (CCS) is a     disease-specific quality of life questionnaire, designed by an American group, to monitor     quality of life in patients undergoing operation for hernias.      The investigators wish to test this questionnaire against Visual Analogue Scale (VAS) scores     for core-hernia symptoms, to see if the CCS is a good way to monitor the changes in quality     of life and other well-known core-symptoms before and after herniotomies.   "
152393|NCT01289080|"     This trial is an open-label, multi-center, parallel-arm, single-dose trial in 2 groups: 1     group of subjects with normal renal function and 1 group of severely renally impaired     subjects.   "
154389|NCT01263002|"     An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and     Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B     Associated Hepatocellular Carcinoma   "
152394|NCT01289067|"     The purpose of the study is to test genes for BRCAness(BRCA[BReast CAncer] gene) Studying     these genes could help predict which patients would benefit from treatment with satraplatin,     a medication being used for subjects who have failed prior chemotherapy. All subjects will     have a biopsy of metastatic lesions to measure BRCAness (a gene signature). This gene     signature may be able to predict response to satraplatin and a tool will be developed to be     able to screen patients likely to benefit from satraplatin. Subjects will all receive     Satraplatin days 1-5 and Prednisone 5 mg twice daily every 35 days. Response rates will be     evaluated every 2 cycles or approximately every 9 weeks. Patients will be considered     responders if they have measurable disease meeting criteria for partial or complete response.     PSA will be measured day one of each treatment cycle. Each treatment cycle is 35 days.   "
152395|NCT01289054|"     This is a voluntary, international, primarily prospective, observational, exposure-registry     and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six     months prior to pregnancy.   "
152401|NCT01288976|"     The MitraClip System enables the European physicians an alternative therapeutic option for     patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac     surgery, and palliative medical therapy with or without device therapy. The study will     observe the outcomes of patients treated with the MitraClip System throughout 12-months as     compared to the outcomes of patients treated by alternative therapies.   "
152402|NCT01288963|"     The purpose of this study is to determine which participants with melanoma have a better     response to IL-2 and to identify markers that may predict response to IL-2 by collecting     participant information (for example; cancer diagnosis and history, prior treatments for     cancer, etc.) blood and tumor samples prior to treatment and tumor measurements after     treatment.   "
152403|NCT01288950|"     The purpose of this study is to determine whether a single oral dose of vitamin D given to     infants prior to Bacille-Calmette-Guerin (BCG) vaccination will enhance the immune response     to BCG vaccination.   "
152404|NCT01288937|"     Milnacipran helps serotonin and noradrenaline work more effectively on the central nervous     system. Serotonin and noradrenaline are molecules made by the brain that affect how your body     responds to pain. Milnacipran, a dual norepinephrine and serotonin reuptake inhibitor has     been a safe and beneficial treatment for patients with fibromyalgia and may be useful to     treat patients with painful peripheral neuropathy. Many clinical trials for neuropathy pain     are done in patients with diabetic neuropathy. Idiopathic neuropathy however, is a common     cause of neuropathy and accounts for 25% of all neuropathies, and over 50% of small fiber     neuropathies. The information in this study will provide information on whether milnacipran     also provide benefit as a medication for neuropathic pain.   "
152405|NCT01288924|"     The purpose of this study is to compare the efficacy of parecoxib with placebo on the     incidence and severity of postthoracotomy shoulder pain, the amount of analgesic requirement     for relieving severity of postthoracotomy shoulder pain and adverse events associated with     treatment.   "
152406|NCT01288911|"     The purpose of this study is to determine the efficacy and safety of oral enzalutamide     compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed     while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a     bilateral orchiectomy.   "
152407|NCT01288898|"     This study determined the safety of ASP1941 after a single and multiple once-daily doses for     10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD)     of ASP1941 were assessed.   "
152408|NCT01288885|"     This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics     (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether     the intake of food had an effect on the PK of ASP1941 (Part B).   "
152409|NCT01288872|"     The purpose of the study is to understand whether the drug praziquantel (PZQ) is metabolized     or broken down differently when women are pregnant versus not pregnant. PZQ is used to treat     schistosomiasis (worm infection). Researchers will study how PZQ is broken down among 15     women who are 12-16 weeks pregnant, 15 women who are 30-36 weeks pregnant, and 15 women     nonpregnant women who are producing breast milk. All women will be 18 or older and otherwise     healthy. The usual practice is to wait until after mothers have finished pregnancy and breast     feeding before giving PZQ. Participants will receive 2 doses of PZQ separated by 3 hours.     Study procedures will include a 24 hour hospital stay following administration of PZQ, blood,     stool and urine samples, ultrasound if pregnant, and physical exams of mother and baby.     Patient participation for mother/infant pair is about 9 months.   "
152410|NCT01288859|"     Polyphenolic compounds exert several health benefits depending on bioavailability.     Encapsulation may improve bioavailability of these compounds.This study will evaluate     bioavailability of some polyphenols (curcumin and cocoa polyphenols) from new enriched-foods.     In particular bread and nut based creams will be used as food matrices to include free or     encapsulated polyphenols.   "
158110|NCT01214421|"     To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from     baseline (from trial 156-04-251) in total kidney volume (TKV) and renal function.   "
152411|NCT01288846|"     30 patients acute hospitalized to medical ward and their medication records are examined. It     is to be recorded how the investigators find information about medicine use by the reception     when they do not follow the patient. The record of the changes made during hospital stay is     examined, whether they are justified in the discharge summaries and whether they are     described in the medical list. After a month is to find out if the GP has recorded or     possibly rejected changes to medication made in hospital.   "
152412|NCT01288833|"     The investigators hypothesize that high definition colonoscopy with close focus narrow band     imaging features has a high diagnostic accuracy for colorectal polyp histology, and can     replace formal pathologic assessment in cases of high diagnostic confidence.   "
152413|NCT01288820|"     This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium     vivax malaria during November 2010 to March 2012. The aim of the study is to compare the     efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and     dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria. The     significance of the study is to find alternative drug for treating patients with vivax     malaria in case the standard treatment is not available or become resistance. This study will     give thorough information about the efficacy and safety of 2 artemisinin-based combination     therapies (ACTs) in combination with primaquine. It will also inform the Indonesian Ministry     of Health on their suggested policies for radical cure of vivax malaria, and provides     evidence based treatment options for chloroquine resistant vivax malaria. This study will     also provide information about prevalence of glucose-6-phosphate dehydrogenase (G6PD)     deficiency and G6PD variants in North Sumatera population.   "
152414|NCT01288807|"     The investigators want to study the effects of milnacipran treatment on neurotransmitter     release in fibromyalgia.   "
152450|NCT01288339|"     To estimate the progression free survival for subjects treated with panitumumab in     combination with a chemotherapy regimen of oxaliplatin, 5-Fluorouracil (5-FU) and leucovorin     (FOLFOX) as first-line chemotherapy regimen for subjects with metastatic colorectal cancer     with WT (wild type) KRAS according to the IGFRp (protein receptor insulin growth factor) and     MMP-7 (Matrilysin) expression.   "
153972|NCT01268449|"     The purpose of this study is to determine wether low dose laser is effective on idiopathic     subjective tinnitus.   "
152415|NCT01288794|"     Ascites is the most frequent complication of liver cirrhosis and carries a significant     worsening of the prognosis. Approximately 10% of patients per year develop refractory ascites     because of either the lack of response to medical treatment or the onset of diuretic-induced     complications that preclude the use of an effective dosage. Refractory ascites is associated     with an increased incidence of severe complications of cirrhosis. Thus, the overall     probability of survival of patients with refractory ascites is very poor, being approximately     30% at 2 years. Repeated large-volume paracentesis, transjugular intrahepatic portosystemic     shunt (TIPS), and liver transplantation represent the therapeutic alternatives for refractory     ascites. As renal sodium retention and ascites formation are the consequence of portal     hypertension and effective hypovolemia, the preservation of the central blood volume     represents a major purpose in the management of patients with advanced cirrhosis. Although     albumin is responsible for about 70% of the plasma oncotic pressure, the absence of large     multicenter randomized studies together with its high cost explains why albumin infusion is     not usually included among the therapeutic options for difficult-to-treat ascites.      The objective of the present study is to define the effectiveness of the prolonged     administration of human albumin in the treatment of liver cirrhosis with ascitic     decompensation. This goal will be reached by performing a multicenter, prospective,     randomized clinical trial comparing the efficacy of chronic albumin administration on top of     standard medical treatment versus standard medical treatment alone in patients with cirrhosis     and ascites.      The study will be conducted in 44 Italian clinical centers and will enrol 440 in- or     out-patients affected by liver cirrhosis with uncomplicated ascites who will be randomized     with a ratio of 1:1. The duration of the study for each patient is 18 months from     randomization. The enrolment of patients will last 18 months and will be competitive between     centers. Treatment will be interrupted if one of the following condition occur: orthotopic     liver transplantation, TIPS, need of 3 paracentesis/month (indication to TIPS), patient     refusal to continue, and medical judgement.      An ancillary optional study will be performed in a subset of patients to analyze the     non-oncotic properties of albumin.   "
152416|NCT01288781|"     The purpose of this study is to determine whether increased pressure in the head is elevated     in people who suffer from High Altitude Headache. We hypothesise that head pressure will be     elevated in people with High Altitude Headache.   "
152417|NCT01288768|"     The purpose of this study is to determine whether a knee arthroscopy is effective in the     treatment of middleaged patients with meniscal symptoms also receiving a standardised     exercise program.   "
152418|NCT01288755|"     The purpose of this study is to investigate the effect of steady-state concentrations of     raltegravir (administered as 400 mg, twice daily) on the steady-state pharmacokinetics of     TMC278 (25 mg, once daily), and vice versa. Steady state is a term that means that the drug     has been given long enough so that the plasma levels will remain at about the same level with     each subsequent dose. TMC278 is being investigated for the treatment of human     immunodeficiency virus (HIV) infection. Raltegravir is a commercially available     antiretroviral drug for treatment of HIV infection. Pharmacokinetics (PK) means how the drug     is absorbed into the bloodstream, distributed in the body and eliminated from the body.   "
152419|NCT01288742|"     The purpose of this study is to investigate the effect of steady-state concentrations of     TMC435 on the single-dose pharmacokinetics of digoxin or rosuvastatin , and the effect of a     single dose of digoxin or rosuvastatin on the steady-state pharmacokinetics of TMC435. Steady     state is a term that means that the drug has been given long enough so that the plasma     concentrations will remain the same with each subsequent dose. TMC435 is being investigated     for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means     how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from     the body.   "
152420|NCT01288729|"     This is an open-label cross over study looking to compare the length of infusion set wear     between a teflon catheter (Quick-Set) or a steel (Sure-T) catheter.   "
152421|NCT01288716|"     To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the     treatment of social withdrawal in subjects with autism spectrum disorders   "
152422|NCT01288703|"     The objective of this pilot-study is to evaluate the feasibility and acceptability of PROMIS     computerized-adaptive testing in women with urinary incontinence.   "
152423|NCT01288690|"     This interventional, randomized controlled study tests the effects of a a brief psychological     intervention (Narrative Exposure Therapy) against a wait list control group among refugees     who have experienced trauma and have some symptoms of PTSD.   "
152424|NCT01288677|"     The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of     single oral doses of TMC649128 in healthy volunteers. Pharmacokinetics (PK) means how the     drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.   "
152425|NCT01288664|"     This is a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release     Capsules (ADVAGRAF) for the induction therapy of Lupus Nephritis (LN) (V, III +V, IV+V).   "
152426|NCT01288651|"     Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency were     previously shown to have a decreased six-minute walking distance. Therefore the investigators     hypothesized that intravenous iron administration would improve exercise capacity in iron     deficient IPAH patients.      30 patients will be recruited for iron infusions. At baseline and after 12 weeks     (endpoint)exercise test will be performed.   "
152427|NCT01288638|"     The purpose of our study is to evaluate the effectiveness of a lifestyle program for women     with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the effect of a     pulse-based diet (i.e. a diet that contains lentils, chick-peas, peas, and beans) and aerobic     exercise for improving PCOS disease features and risk factors for metabolic syndrome. We     would like to determine the therapeutic effects of a lifestyle program that combines a     pulse-based diet and exercise on the multiple disease measures of PCOS and metabolic     syndrome.   "
152428|NCT01288625|"     The purpose of this study is to compare the incidence of stomatitis when treating with     amifostine before radiation treatment.   "
152429|NCT01288612|"     The hypothesis of this study was that the comparative effectiveness of unsedated transnasal     endoscopy (uTNE) will be greater than sedated endoscopy (sEGD) in population screening for     BE.   "
152447|NCT01288378|"     RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients     with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their     cancer. It is not yet known whether caspofungin acetate is more effective when treatment     starts after development of a fever or after the infection is shown in laboratory test, chest     x-ray, or CT scan.      PURPOSE: This randomized phase III trial is studying the best time to start caspofungin     acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome     that is newly diagnosed or in first relapse.   "
152448|NCT01288365|"     The purpose of this study is to determine whether exercise training will improve functional     capacity in patients with heart failure and preserved ejection fraction.   "
155446|NCT01249196|"     The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients     with mild to moderate Alzheimer's disease.   "
152430|NCT01288599|"     Keyhole surgery for adnexal disease has traditionally been performed using three or four     small incisions. The last years a new operating method has been introduced. This method makes     use of only one incision of 2 cm in the umbilicus. This method is less invasive, and it might     benefit the patient through less postoperative pain and a higher satisfaction with the     cosmetic result. So far, many studies have shown that this new method is feasible for adnexal     disease, but its superiority compared to conventional laparoscopy is to be proven. This study     aims to show this difference.      The investigators aim to compare experienced postoperative pain and use of analgesics in     patients undergoing single port laparoscopy for benign adnexal disease with conventional     laparoscopy. The investigators hypothesize that the patients will experience less     postoperative pain and use less analgesic in the single port laparoscopy group.      Further, the investigators aim to compare the satisfaction with the cosmetic results in the     two groups. In addition, blood loss, operating time, complications and conversion to     conventional laparoscopy will be registered in the two groups.   "
152431|NCT01288586|"     The purpose of this study is to examine the long term survivorship of the Scandinavian Total     Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal     rate of any component of the STAR ankle.   "
152432|NCT01288573|"     This is a multi-site study with plerixafor in pediatric cancer patients. The study will be     conducted in 2 stages:        -  Stage 1 is a dose-escalation study.        -  Stage 2 is an open-label, randomized, comparative study using the appropriate dosing          regimen identified in the Stage 1 dose-escalation study.      All participating patients will receive a standard mobilization regimen as per study site     practice guidelines (either chemotherapy plus once daily granulocyte-colony stimulating     factor (G-CSF) or once daily G-CSF alone). The only change to the standard mobilization     regimen is the addition of plerixafor treatment prior to apheresis for all patients in Stage     1 (dose escalation), and for those patients randomized to the plerixafor plus standard     mobilization treatment arm in Stage 2 (randomized, comparative).      Stage 1 will enroll at least 27 patients. Stage 2 will enroll at least 40 patients.   "
152433|NCT01288560|"     Medical imaging is one of the fastest growing sectors in health care and increases in     utilization underscore the need to ensure imaging technology is developed and used     effectively. Evaluation of the clinical and economic impact of such imaging lags behind the     technology development. Heart failure (HF)represents the final common pathway for most forms     of heart disease and morbidity and mortality remain high. There is a need to identify imaging     approaches that have a positive impact on therapy decisions, patient outcomes and costs. As     well as standard methods to evaluate new and emerging techniques to better test their     potential in a clinical management setting. The OVERALL OBJECTIVES of the IMAGE-HF trial are     1) to determine the impact of emerging imaging strategies, on relevant clinical outcomes and     decision making in patients with HF; 2) to establish standardization quality assurance (QA)     measures and central databases in order to achieve reliable outcome driven research; 3) to     apply this as a platform for evaluation of new and emerging imaging biomarkers in HF.      Project I-A: The PRIMARY OBJECTIVE OF AIMI-HF is to compare the effect of HF imaging     strategies on the composite clinical endpoint of cardiac death, MI, resuscitated cardiac     arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia). Patients with an ischemic heart     disease (IHD) etiology will follow HF imaging strategy algorithms according to the     question(s) asked by the physicians (is there ischemia and/or viability), in agreement with     their local practices for standard and alternative imaging.      Secondary objectives of AIMI-HF To compare the effect of HF imaging strategies on        1. The incidence of revascularization procedures (PCI, CABG)        2. LV remodeling: LV volumes, LVEF        3. HF symptoms, NYHA class        4. QOL (MLHFQ, the EQ5D)        5. The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP)        6. Health economics: Costs estimated through regression analysis and cost effectiveness          assessed through decision modeling.        7. The safety of imaging tests measured by cumulative radiation, adverse reactions to          imaging contrast agents and stress testing agents will also be determined.        8. The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g.          PIIINP, OPN).   "
152434|NCT01288547|"     The purpose of this study was to measure potential mood, cognition and blood pressure effects     of theobromine and caffeine in healthy women   "
152435|NCT01288534|"     The purpose of this study is to evaluate the safety and tolerability of using radiation     therapy with 5 fractions of radiation to treat prostate cancer with guidance of radiation     using the Calypso 4D Treatment System (Calypso).A number of recent studies have used 5     radiation fraction to treat prostate cancer over 2-3 weeks as compared to the typical     treatment which would involve 40-42 smaller radiation fractions over 8-9 weeks. This type of     radiation using a smaller number of treatments has been called hypofractionated radiation     therapy.      The Calypso is a new technique which uses beacons implanted into the prostate which using     radio signals are able to localize and track the position of the prostate continuously during     radiation therapy. The Calypso system has been approved by the United States Food and Drug     Administration (FDA) for guidance of radiation therapy during the treatment of prostate     cancer and is being utilized all across the United States. However, it has not been tested     for hypofractionated radiation therapy.   "
152442|NCT01288443|"     Primary Objective:        -  To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein          cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in          participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin          therapy.      Secondary Objectives:        -  To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment          in comparison with placebo        -  To evaluate the safety and tolerability of alirocumab        -  To evaluate the development of anti-alirocumab antibodies        -  To evaluate the pharmacokinetics of alirocumab   "
152443|NCT01288430|"     This phase 1 clinical trial is intended to understand the safety and tolerability of a new     anticancer drug in subjects with advanced solid tumors. The patients who qualify for the     study will receive a once daily dose of the drug taken by mouth and will undergo several     tests to measure the drug in the blood and to understand the safety, tolerability and any     effect of the drug on the tumor. The antitumor effect of the drug is not known in human.   "
152449|NCT01288352|"     EAST prospectively tests the hypothesis that an early, structured rhythm control therapy     based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF)     related complications in patients with AF when compared to usual care.      Patients will be randomized to early therapy or usual care. In the early therapy group,     patients will receive either catheter ablation (usually by pulmonary vein isolation), or     adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be     selected by the local investigator. Upon AF recurrence, both modalities will be combined.      Usual care will be conducted following the 2010European Society of Cardiology ( ESC     )guidelines for AF treatment. Early rhythm control therapy will be guided by     Electrocardiogram (ECG) monitoring.   "
168445|NCT00033059|"     The purpose of this study is to assess the potential interactions between intravenous (IV)     cocaine and tolcapone.   "
152436|NCT01288521|"     Solid organ transplant recipients would greatly benefit from pharmacogenetic evaluation since     immunosuppressive drug regimens consist of multiple medications with narrow therapeutic     ranges and toxic adverse event profiles. Tacrolimus is a potent immunosuppressive agent     utilized for rejection prophylaxis. Intensive pharmacokinetic monitoring must be performed     following organ transplantation to ensure therapeutic drug concentrations due to its highly     variable pharmacokinetics profile and narrow therapeutic index. Tacrolimus is a substrate for     CYP450 3A and for the membrane transporter p-glycoprotein (Pgp). Polymorphisms in the gene     encoding for CYP3A5 have been extensively studied and have been found to influence the dosing     of tacrolimus. The effect of ABCB1 gene polymorphisms (which encodes for Pgp) upon tacrolimus     pharmacokinetics has been more difficult to establish.      This study will determine if haplotypes derived from three frequent polymorphisms in the     ABCB1 gene (C1236T, G2677T, C3435T) can predict the degree of drug interaction between     tacrolimus (CYP3A5/Pgp substrate) and ketoconazole (CYP3A5/Pgp inhibitor) in patients who are     CYP3A5 nonexpressors.      This prospective pharmacokinetic and pharmacogenomic study will enroll 20 stable renal     transplant recipients with the CYP3A5 *3/*3 genotype and grouped by ABCB1 haplotype (CGC vs     TTT). Pharmacokinetics of tacrolimus will be assessed on 2 occasions with and without     ketoconazole coadministration separated by 1 week. The order of study occasions will be     randomized in a crossover design.      The results of this study may identify a genomic marker for predicting drug-drug     interactions. Knowing this information a priori will aid clinicians in modifying drug dosing     and alleviate patients of the burden of significant drug toxicities.   "
152437|NCT01288508|"     Background: Whether Supra-Fiber, a plum-derived fiber supplement is useful in the treatment     of constipation is not known. Supra Fiber is the first fiber supplement that has a blend of     whole food fruit as its main ingredient. It contains prunes, pomegranates, blueberries, and     Acai berries. Unlike psyllium, which is mostly (90%) insoluble fiber, Supra Fiber is a     balanced (50%) blend of insoluble and soluble fiber. This may provide the beneficial effects     of fiber, and eliminate potential adverse symptoms of fiber such as bloating, distention,     hard bulky stools and excess gas. In this study, we expect to not only evaluate the efficacy     but also the palatability and tolerability of Supra Fiber in the treatment of chronic     constipation.      Aims:        1. To investigate and compare the effects of Supra Fiber (5 grams BID) or psyllium (5 grams          BID) on the number of complete spontaneous bowel movements per week, and bowel symptoms.        2. To examine the effects of fiber supplements on taste and quality of life in adults with          functional chronic constipation in a randomized, double-blind, parallel group controlled          trial.      Methods: We propose to enroll 90 subjects with functional constipation in a single blinded,     randomized, cross-over study comparing 4 weeks of Supra Fiber with 4 weeks of treatment with     Psyllium      Data analysis: The primary outcome measure will be the global relief of constipation symptoms     as rated by the subject at the end of each phase of the study. Additionally, we will assess     several secondary outcome measures that will include the number of Complete Spontaneous Bowel     Movements (CSBM) per week, Quality of Life , psychological profile, patient rating of taste     on a VAS scale, patient rating of bloating, distension, satiety and fullness and patient     rating of constipation-related symptoms.      Expected results: We anticipate that treatment with Supra Fiber will improve symptoms of     constipation compared to the baseline. This improvement will be comparable or superior to     that achieved with psyllium treatment. Additionally, Supra Fiber will offer a natural, food     based, convenient and more tasty alternative to over-the-counter laxatives and fiber     supplements.   "
152438|NCT01288495|"     Data suggest that alanine may facilitate the intestinal absorption of fructose in patients     with DFI and thereby may decrease GI symptoms.      We hypothesize that the ingestion of supplemental L-alanine along with mixed meals or snacks     that contain foods with free fructose or high fructose content will decrease GI symptoms in     subjects with dietary fructose intolerance by facilitating intestinal absorption of fructose.      Aim: To investigate the effects of co- administration of equi-molar doses of L-alanine or     placebo on the occurrence of GI symptoms in subjects with dietary fructose intolerance, in a     randomized, double blind, cross over study.      Methods: We propose to investigate the effects of co-administration of equi-molar doses of     L-alanine or placebo on the occurrence of GI symptoms in 70 subjects with dietary fructose     intolerance, in a randomized, double blind, cross over study.      Data Analysis: The primary outcome measure will be a comparison of baseline breath sample     values and study visit breath sample values. Additionally, we will assess subject-reported     occurence and severity of nine gastrointestinal symptoms during the test on a visual analog     scale (VAS).      Expected Results: We anticipate that dietary fructose intolerance (DFI) symptoms will improve     with ingestion of supplemental L-alanine (along with foods containing free fructose or high     fructose content). We additionally expect treatment of DFI with administration of L-alanine     powder to be more practical than co-ingestion of alanine-rich foods, and more convenient for     patients.   "
152439|NCT01288482|"     Traditional, continuous-mode nebulizers such as the English-Wright nebulizer are designed to     operate continuously with tidal breathing. As inhalation accounts for only about one-third of     the respiratory cycle, two-thirds of the continuously produced aerosol is lost to the     environment possibly posing a hazard any fellow-patients, family members, or health-care     workers in the vicinity. The English-Wright has been the only American Thoracic Society     (ATS)recommended device available on the market. Recently Roxon Medi-Tech has announced the     discontinuation of the English-Wright nebulizer. For these reasons it is necessary to review     the use of other nebulizers such as the AeroEclipse II breath-actuated nebulizer and further     validate their performance.      The investigators expect to show equivalence between the AeroEclipse II and the     English-Wright nebulizers.   "
152440|NCT01288469|"     Primary Objective:      To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein     cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of     atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L)     on atorvastatin 10 mg.      Secondary Objectives:        -  To evaluate the effects of alirocumab on other lipid levels in comparison with placebo,          when co-administered with 80 mg of atorvastatin after 8 weeks of treatment.        -  To evaluate the efficacy of alirocumab when co-administered with a high dose of          atorvastatin (80 mg) versus atorvastatin 10 mg.        -  To evaluate the safety and tolerability of alirocumab when co-administered with 2          different doses of atorvastatin.        -  To evaluate the development of anti-alirocumab antibodies.        -  To evaluate the pharmacokinetics of alirocumab.   "
152441|NCT01288456|"     This will be an observational, prospective, non-randomized, pilot study to gain initial     device experience on a novel space-occupying device in persons who are overweight or obese.     No formal hypothesis testing will be conducted.   "
152444|NCT01288417|"     The objective of this study is to evaluate the effect of boceprevir (steady state) on the     pharmacokinetics of a single dose of raltegravir. The effect on the boceprevir     pharmacokinetics of a single dose raltegravir will also be evaluated (compared to historical     controls). Furthermore, the safety profile of the combination is studied.   "
152451|NCT01288326|"     The study is conducted in Europe. The aim of this observational study is to assess glycaemic     control while using liraglutide under normal clinical practice conditions in Belgium.   "
152452|NCT01288313|"     We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic     acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating     women   "
152453|NCT01288300|"     Main objective: To improve diabetes outcomes among Mexican-Americans with diabetes through     church-based, culturally tailored, diabetes self-management interventions linked to the local     healthcare system.      Specific Aim: To pilot test a church-based, culturally tailored diabetes self-management     intervention to improve diabetes outcomes among low-income Mexican-American with diabetes      H1 A church-based diabetes self-care management curriculum partnered with the local     healthcare system will improve glycosylated hemoglobin.      H2 A church-based diabetes self-care management curriculum partnered with the local     healthcare system will improve systolic blood pressure and low-density lipids.      H3 A church-based diabetes self-care management curriculum partnered with the local     healthcare system will improve diabetes related self-efficacy, self-empowerment and self-care     management.   "
152454|NCT01288287|"     To determine if early clinical response at 12 weeks to Certolizumab Pegol (CZP, Cimzia ®)     therapy in adult Rheumatoid Arthritis (RA) patients is a predictor of better long term     clinical response at 18 months compared with a lack of clinical response at 12 weeks.   "
152455|NCT01288274|"     The purpose of this study was to demonstrate that with appropriate training, the provision of     injectable contraceptives by community based reproductive health agents (CBRHAs) does not     significantly differ from low-level clinic-based providers, or health extension workers     (HEWs).   "
152456|NCT01288261|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bavituximab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Giving paclitaxel together with bavituximab     may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects of giving paclitaxel and bavituximab     together in treating patients with Human Epidermal growth factor Receptor 2 (HER2 )-negative     metastatic breast cancer   "
152457|NCT01288248|"     The purpose of this study is to determine whether the use of laryngeal mask classic as method     for securing the airway in the population of 2 years to 14 years is associated with risk of     laryngospasm as compared with the use of endotracheal tube.   "
152458|NCT01288235|"     Some patients with brain tumors receive standard radiation to help prevent tumor growth.     Although standard radiation kills tumor cells, it can also damage normal tissue in the     process and lead to more side effects. This research study is looking at a different form of     radiation called proton radiotherapy which helps spare normal tissues while delivering     radiation to the tumor or tumor bed. Proton techniques irradiate 2-3 times less normal tissue     then standard radiation. This therapy has been used in treatment of other cancers and     information from those other research studies suggests that this therapy may help better     target brain tumors then standard radiation.   "
152459|NCT01288222|"     Donors with favorable KIR B haplotype gene content have yielded reduced relapse risk and     improved leukemia free survival (LFS) in retrospective analyses of unrelated donor (URD)     hematopoietic cell transplantation (HCT) for acute myelogenous leukemia (AML). Specifically,     donors with more KIR B gene content and those who are homozygous for the centromeric (Cen) B     haplotype genes (as opposed to the telomeric (Tel) genes confer the most protective effect.     This study proposes to prospectively test and validate the utility and effectiveness of     further informing URD identification and selection by KIR genotyping as a supplement to HLA     matching and the other variables known or suspected to indicate the best URD for a patient.      Hypotheses:        1. Favorable KIR donors will improve protection against relapse and improve leukemia free          survival (LFS) after URD HCT for AML.        2. Directed study procedures for rapid KIR genotyping and reporting to searching Transplant          Centers (TC) can inform donor search and selection without delay in donor availability          for HCT.   "
152460|NCT01288209|"     The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination     with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus     (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy     in Japan.   "
152463|NCT01288170|"     Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis     Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the     respiratory affection which appears early in neonates.      The constant improvement in symptomatic treatments and care strategies allowed CF patients'     life expectancy to be increased over the last decades.      Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years     old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.      Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is     obtained by inhaled administration of tobramycin and is active against in vitro resistant     Pseudomonas aeruginosa.      Study hypotheses :      Regarding literature data and in vitro studies, the administration of Nebcinal® 150mg/3ml     administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of     antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus®     in children and adult patients with CF.      Primary objective :      To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by     Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®   "
152464|NCT01288157|"     The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male     participants.   "
152476|NCT01287988|"     The primary objective of this study is to assess visual function in up to 44 patients who     have previously participated in either of the placebo controlled, ocriplasmin Phase III     studies (TG-MV-006 or TG-MV-007).   "
152494|NCT01287754|"     This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib)     in patients with locally advanced or metastatic non-small cell lung cancer with epidermal     growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg     daily orally until disease progression or unacceptable toxicity occurs.   "
152465|NCT01288144|"     The investigators hypothesize that computer-assisted decision support will increase the     percentage of women with a history of gestational diabetes who receive appropriate follow-up     screening.      Specific Aim 1: Develop an algorithm to identify cases of gestational diabetes among patients     in the Partners Health Care system using administrative and laboratory data.      Specific Aim 2: Assess primary care provider knowledge, attitudes, beliefs, and barriers to     compliance regarding screening guidelines for women with a history of gestational diabetes.      Specific Aim 3: Test whether a computer-assisted decision support tool to identify patients     with a GDM history and prompt screening will increase compliance with guidelines. The     investigators hypothesize that decision support will significantly increase in the percentage     of women screened.   "
152466|NCT01288131|"     Recombinant human erythropoietin (r-HuEpo) has been used to treat renal anemia and improve     morbidity and mortality in chronic kidney disease. Subcutaneous use of r-HuEpo causes     immunogenicity and develops anti-r-HuEpo associated pure red cell aplasia (PRCA). The     treatment of anti-r-HuEpo associated pure red cell aplasia is controversial. The     investigators aim to evaluate the treatment for anti-r-HuEpo associated pure red cell aplasia     in this study.   "
152467|NCT01288105|"     The specific aim of this proposal is to examine the impact of OCT and IVUS-guided management     of patients with prior DES implantation who need major non-cardiac surgery and     discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery     until 30 days post surgery) incidence of major adverse cardiac events.   "
152468|NCT01288092|"     This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage     design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in     patients with progressive metastatic HR+ HER2- breast cancer who have received at least one     prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic     disease. Patients will be stratified into 3 groups according to their PI3K     (phosphatidylinositol 3-Kinase) pathway activation status.   "
152469|NCT01288079|"     The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy     in patients with major depressive disorder who exhibit inadequate response to     antidepressants.   "
152470|NCT01288066|"     The clinical question on whether or not to replace the glenoid component in patients with a     degenerative shoulder disease, has not been answered yet in a randomized study with enough     statistical power. In this study, patients are randomly allocated to a treatment with a hemi-     or total shoulder arthroplasty using implants of the Epoca system. The primary objective is     the comparison of pain and function between the treatment groups after 5 years using the     Constant score.   "
152471|NCT01288053|"     Allogeneic transplantation has been a high-risk procedure, although non-myeloablative     conditioning regimens (mini-transplantation) minimizes regimen related toxicity. The     investigators, therefore, propose a phase I study of matched sibling allogeneic hematopoietic     stem cell transplantation with non-myeloablative conditioning. In addition, graft versus host     disease (GVHD) will be virtually eliminated by CAMPATH that removes donor T cells from the     graft.      The goal is to assess the toxicity/efficacy (phase I) of allogeneic non-myeloablative     hematopoietic stem cell transplantation for high-risk Crohn's disease. In simplistic terms,     this protocol is designed to ablate an aberrant immune system and then, similar to the use of     marrow transplants for immunodeficient patients, reconstitute a new immune system with     lymphocyte depleted marrow.   "
152472|NCT01288040|"     The purpose of this study is to determine whether split belt training can be used to treat     walking pattern deficits from stroke and to determine whether different schedules and types     of long term training on a custom split belt treadmill are likely to change/improve walking     symmetry.   "
152473|NCT01288027|"     This is an open-label, multicenter study of participants with late-onset Pompe disease naive     to treatment with enzyme replacement therapy (ERT). The primary objective of this study is to     evaluate glycogen clearance in muscle tissue samples collected pre and post alglucosidase     alfa treatment in participants with Late-Onset Pompe disease.      The secondary objectives are to characterize the disease burden in participants with     late-onset Pompe disease and explore imaging, histologic, and functional assessments in these     participants and to explore potential plasma or urine biomarkers relative to late-onset Pompe     disease and participant's response to treatment with alglucosidase alfa     (Myozyme®/Lumizyme®/GZ419829).   "
152488|NCT01287832|"     There is an increased failure rate for the treatment of Staphylococcus Aureus Bacteremia     (SAB) with traditional doses of vancomycin, the standard of care for patients with MRSA     bacteremia over the last 40 years. This has been largely attributed to isolates with     increased resistance to vancomycin (increased MIC). Daptomycin is an antibiotic that was     approved several years ago for the treatment of SAB and is being increasingly used for MRSA     bacteremia due to isolates with increased MIC. Increased doses have been recommended for both     of these drugs in the treatment of this infection without a trial demonstrating their     relative efficacy or safety at higher doses. This study will randomize patients with SAB due     to MRSA with an increased MIC to determine the relative efficacy and safety of vancomycin and     daptomycin used at higher than traditional doses.   "
152474|NCT01288014|"     After immunization, particularly in older persons, some people are protected from disease by     a vaccine and others are not. The investigators believe that this variable response may be     due to overproduction of molecules that suppress development of immunity (antibodies and cell     mediated immunity). Normally, these molecules are produced to make sure that immunity is     regulated in just the right way for the body as a whole, and to prevent autoimmune disease.      However, with aging, the immune system may have difficulty in proper immune regulation. Over     production of immunosuppressive molecules after vaccination may interfere with the effects of     a vaccine. For example when elderly individuals are immunized against zoster with a licensed     vaccine, Zostavax, the vaccine is effective in only about 50 to 60%. The investigators will     compare blood levels of antibodies, cellular immunity, and immunosuppressive molecules in     recipients of Zostavax to see if there is a correlation between development low immunity and     high levels of immunosuppressive molecules.   "
152475|NCT01288001|"     A pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of     one intra articular injection of sodium hyaluronate 2.0% in patients with painful     osteoarthritis of the knee   "
168446|NCT00033072|"     The purpose of this study is to assess the potential interactions between intravenous     methamphetamine and oral selegiline.   "
152477|NCT01287975|"     This study is carried out to find out if Brain Computer Interface (BCI) technology or BCI     technology coupled with robotic technology using a Haptic Knob will benefit patients with arm     paralysis after stroke. BCI uses EEG-based motor imagery to detect user's thinking abilities     which control motor movement. Haptic Knob is a novel robotic device, which specifically     trains the wrist and hand with intensive repetitions in a supported environment.   "
152478|NCT01287962|"     Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase     inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II     clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated     toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present     phase III trial, the investigators will further evaluate the efficacy and toxicities of     apatinib in the treatment of advanced non-squamous non-small cell lung cancer.   "
152479|NCT01287949|"     Primary objective:        -  To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0,          1 and 6-month schedule induce an acceptable immune response in terms of seroprotection          rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40          years of age or older with no diphtheria- and tetanus-containing booster within the last          20 years        -  To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of          the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these          subjects      Secondary objectives:        -  If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine          containing Td-IPV valences induce an acceptable response in terms of seroprotection          rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40          years of age or older with no diphtheria- and tetanus-containing booster within the last          20 years        -  To describe the immune responses to REPEVAX in these subjects        -  To describe the immune responses to REVAXIS administered 1 and 6 months after the          administration of REPEVAX in these subjects   "
152480|NCT01287936|"     The primary purpose of the clinical study is to determine the safety of a modified stem cell     SB623 when administered to chronic, stable ischemic stroke patients. A second purpose is to     determine whether SB623 might improve stroke symptoms. Chronic, stable ischemic stroke     patients must be between 6 and 60 months after their stroke, and with only this one prior     stroke, and and with no further improvement from physical therapy.   "
152481|NCT01287923|"     Diffuse Large B-cell Lymphoma (DLBCL) is the most frequent high grade lymphoma in adults.     Although immunotherapy has improved its prognosis, DLBCL is a heterogeneous disease with     patients exhibiting a wide range of outcomes with a 5-year overall survival ranging between     55 to 94% depending of the International Prognostic Index factor. Diagnostic and prognostic     biomarkers are mandatory to optimize treatment. Transcriptomics has been used to detect such     new biomarkers using microarrays analyses applied to RNA collected from total tumor tissues     or cell extracts. Molecular prognostic factors have been thoroughly studied in DLBCL tumor     tissues. However, it is a big challenge to obtain transcriptomic-qualified tumor samples in a     multicentric and prospective clinical trial. We hypothesized that blood may be a deep source     of native and secreted analytes and therefore carries transcriptomic signatures related to     DLBCL and its prognosis. Our project is organized in the extension of the GOELAMS-075     clinical trial which concerns aggressive DLBCL.      Two complementary approaches will be followed, one at the transcriptomic level for     confirmation of diagnostic biomarkers and to assess for predictive biomarkers. The other one     concern biologic studies to validate our biomarkers at the tissue level. Our project will be     organized around 4 workpackages (WP), each of them includes tasks with a specific schedule &     predefined deliverables. The first one concerns the general management, data warehouse,     collections and different administrative and preanalytic issues. The 3 other WPs are     scientific. We are first going to validate a 30-gene list, candidate diagnostic biomarkers,     by qRT-PCR on: *) an independent set of DLBCLs compared to matched healthy blood donors     (sensitivity assessment) and, **) on a series of low tumor burden DLBCLs, mantle cell     lymphomas and non-malignant inflammatory disease constituted by patients with a septic shock     (specificity assessment). All this latter collections are already available and ready to use.     Secondly, we will complete our series of 89 hybridized patients on AFFY WholeExon microarrays     by 60 supplementary and available samples in order to assess for molecular predictor of     patient outcome. This question will be address based on the 3-year and 5-year as well, EFS     (Event Free Survivor). All the clinical data are available through the GOELAMS eCRF. Since we     dispose of a 31 probesets, 30 single genes, signature for the DLBCL diagnosis that involves 9     genes related to the myeloid compartment including 6 genes involved directly or not to the     Myeloid-Derived Cell Suppression (MDSC) process, 20 genes described in the context of the     cancer and, 11 genes connected to endothelial cells, we decided to explore by flow cytometry     blood circulating cells. We will look for myeloid populations & subpopulations, endothelial     cells and microparticles. The goal is the identification of specific MDSC perturbations,     angiogenic abnormalities and functional impacts on the immune response in the context of the     cancer.      We expect by our work to drive both basic science and clinical implications. On the     scientific level, blood carries molecular and cellular components involved in tumor-host     interactions. Our project should bring a deeper understanding in the immunological response     that takes place in the blood compartment. This immunological response will be characterized     on a molecular, cellular and functional level. On a clinical point of view, it may bring a     new prognostic model in DLBCL. As blood is easily accessible, we expect it to be easily     implemented in clinical practice and to allow the design of new clinical trials stratified on     tumor biology features. It may also become a new way to monitor DLBCL's response to     treatment. Furthermore, this project will provide a large amount of molecular data that can     be easily connected with other ongoing GOELAMS studies. Valorisation of our findings will     also be serious issue since our project is highly original and valuable.   "
152482|NCT01287910|"     The primary goal of this study is to better understand how Transmyocardial Laser     Revascularization (TMR) affects the functioning of the heart and, in turn, relieves angina in     individuals with coronary heart disease using Magnetic Resonance (MR) images and Computed     Tomography (CT) images in some patients.   "
152483|NCT01287897|"     This is a proof of concept study to determine the efficacy and safety of a monoclonal     antibody with three doses versus placebo. Subjects will be randomized to a treatment and the     dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate     to severe refractory Crohn's Disease.   "
152484|NCT01287884|"     The primary objective of this study is to identify a correlation between the pH and pCO2 in     arterial and venous blood. The secondary objectives include a correlation of pulse oximetry     and arterial pO2 along with subgroup analyses of specific patient populations such as     congestive heart failure, chronic obstructive pulmonary disease, diabetic ketoacidosis,     pneumonia, overdose, and trauma.   "
152485|NCT01287871|"     This study aims to 1) implement a culturally and contextually rooted innovative multifoci,     social marketing intervention involving societal focused media campaign elements to break     down the barriers and facilitate timely and appropriate screening practices for cervical     cancer; 2) measure cervical cancer stigma from a culturally relevant theoretical and     conceptual framework; and 3) assess the influence of stigma on hindering seeking the PAP     test. Further, this is an international study that will bring together a multi-disciplinary     investigatory team, community advocates and State health agencies to deliver a social     marketing intervention in Southern California (the Inland Empire region specifically) and     Trinidad and Tobago.   "
152486|NCT01287858|"     AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2     hours after dosing) with approximately 240 mL of water either once daily or twice daily. It     is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple     oral doses of AC430.   "
152487|NCT01287845|"     PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of     BAY1075553 in patients with prostate cancer and in healthy volunteers   "
152489|NCT01287819|"     1. Apolipoprotein E gene (ApoE) is the most important genetic factor for Alzheimer disease          (AD) and an important genetic factor for outcome of brain injury situations.        2. Function magnetic resonance imaging (fMRI) is a powerful tool for study of both brain          regional functions and brain network.        3. Study about genetic contribution on fMRI is an emerging concept, which will help on          understanding about how the genetics affecting the brain function.   "
152492|NCT01287780|"     The majority of elderly patients with a displaced fracture of the proximal femur are now     treated with a hemiarthroplasty. Prosthetic joint infection is a devastating complication,     and the infection rate is high in this group of elderly patients. Local application of     gentamicin produces high antibiotic concentrations in the wound. The aim of this study is to     determine whether locally administered collagen-gentamicin in the joint perioperatively in     addition to routine IV prophylaxis with beta-lactam antibiotics can reduce the early     postoperative infection rate (< 4 weeks postoperative)after hemiarthroplasty in proximal     femoral fractures.   "
152493|NCT01287767|"     Dementia is one of the most common and devastating diseases in the elderly, it leads to     helplessness, no cure exists and therefore care is necessary to provide. The care is     associated with a great burden for the family carers and expensive for the society when     residential care is required. The purpose of this study is to improve knowledge on how to     provide better care for both the patients and their family carers, the investigators want to     carry out a controlled trial using a rather cheap form of intervention, a multidimensional     support program - an 18 months randomized controlled intervention study.   "
152708|NCT01284920|"     This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after     oral administration to patients with castration-resistant prostate cancer.   "
152495|NCT01287741|"     This open-label, randomized, parallel group study will evaluate the efficacy and safety of     obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone     or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously     untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large     B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000     milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter     (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV     every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two     doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.   "
152496|NCT01287728|"     Abnormal vaginal flora is currently diagnosed among women (20-40%). It is associated with     symptoms (bad smell, vaginal discharge) and adverse out-comes in pregnant and not pregnant     women. The high recurrence rate raises the long-term effectiveness of therapy. The hypothesis     is the persistence of bacteria associated with vaginal flora imbalance as Atopobium vaginae     and Gardnerella vaginalis. At the present time there is a lack of an accurate marker for the     risk of recurrence.   "
152497|NCT01287715|"     The purpose of this study is to determine whether etanercept can be withdrawn successfully     (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom     disease remission is reached.      Goals:        1. to investigate in a randomized controlled trial:             -  which proportion of JIA patients in remission can successfully discontinue               etanercept compared to JIA patients in remission who continue etanercept;             -  if time in remission on etanercept is an important factor in retaining remission               after discontinuation of etanercept.        2. to investigate in alle JIA patients who discontinue etanercept (including the control          group):             -  predicting factors (patient or disease characteristics, including time in               remission, and MRP8/MRP14) for successfully discontinuation of etanercept;             -  the disease course after discontinuation of etanercept (time to flare) and the               effect of restarting etanercept after flaring.   "
152498|NCT01287702|"     The impact of feeding after endoscopic treatment of gastroesophageal varices has never been     investigated. It is still unknown whether early feeding may increase early rebleeding in     patients with acute esophageal variceal bleeding treated with EVL. It is customary for     clinicians to institute fasting for 2 or 3 days after emergency EVL. This may be a safe     approach to watch against early rebleeding. However, many patients would be fasting for a     longer time and nutrition may be impaired, possibly resulting in aggravation of ascites.     Thus, the investigators conduct a controlled study to evaluate whether early feeding have a     bad impact on patients receiving emergency EVL or histoacryl injection for bleeding gastric     varices.   "
152499|NCT01287689|"     This non-interventional, epidemiological study assesses long-term outcomes in subjects     receiving immunoglobulins (IgG) for any treatment purpose, irrespective of the regimen     prescribed by the treating physician, under routine clinical conditions in Germany.      Long-term outcome data are collected on patient characteristics in the various indications,     drug utilization of intravenous and subcutaneous IgG (e.g. treatment and dosing patterns),     effectiveness (i.e. number of infections), tolerability, health related quality of life, and     economic variables (number of hospitalizations, sick-leave days etc.) with the possibility to     estimate direct costs.   "
152500|NCT01287663|"     Homelessness, also name the fourth world, is a growing public health problem worldwide.     Previous studies showed that up to 30% of the homeless people reported pruritus that often     results in itchy lesions, which expose them to bacterial skin infections.      The investigators therefore conducted a randomized, double-blind, placebo-controlled trial to     test the hypothesis that a single oral dose of ivermectin was effective in significantly     reducing the prevalence of pruritus in a sheltered homeless population.   "
152501|NCT01287637|"     The study is being conducted as a prospective randomized controlled multicenter study of     patients with a temporary ileostomy due to rectal cancer. The study will be conducted in     hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes     Group (www.ssorg.net).      The study investigates the effect of reversing a temporary ileostomy after 8-13 days instead     of later reversal more than 12 weeks after surgery.   "
152502|NCT01287624|"     This is a prospective, multi-center, open-labeled, randomized phase III clinical trial     comparing overall response rate (ORR), progression free survival (PFS), overall survival (OS)     and toxicity obtained with gemcitabine cisplatin combination (GP) versus gemcitabine     paclitaxel combination (GT).   "
152523|NCT01287351|"     This study will compare the absolute and relative effectiveness and cost-effectiveness of     asthma management in patients in the USA on inhaled corticosteroid (ICS) maintenance therapy     as HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone     propionate (FP) pMDI. .   "
152503|NCT01287611|"     Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology     Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S     (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in     subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies,     ...) are very important issues. Classically Kerr incision is repaired with continuous locked     suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in     turn may reduce short and long term complications. For this reason, the investigators aimed     to compare two closure techniques.   "
152504|NCT01287598|"     -  To evaluate the effect of BAY73-4506 on the pharmacokinetics of probe substrates of CYP          2C9 (warfarin), 2C19 (omeprazole) and 3A4 (midazolam) administered in a cocktail          approach and on the pharmacokinetics of a probe substrate of CYP 2C8 (rosiglitazone)        -  To evaluate safety, anti-tumor activity, pharmacokinetics, and pharmacodynamics of          BAY73-4506 in patients with advanced solid tumors   "
152505|NCT01287585|"     This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme     versus placebo in patients with hepatocellular carcinoma who have failed prior systemic     treatment (chemotherapy). Hepatocellular carcinomas have been found to require arginine, an     amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the     hepatocellular carcinoma cells will starve and die.   "
152709|NCT01284907|"     The purpose of this study is to determine whether vitamin D supplements can improve asthma     control in children with moderate to severe asthma   "
152506|NCT01287572|"     Pediatric patients admitted to the intensive care unit and requiring conscious sedation for     minor surgical procedures are at risk to hypoventilate and retain CO2.      The rise in CO2 levels is not well described and unpredicted. In this study the investigators     will monitor CO2 levels transcutaneously using SDMS (SenTec digital Monitoring System) a     device recently approved for clinical use. The hypothesis is ventilation of patients     undergoing conscious sedation is compromised and CO2 levels might rise significantly to     levels that potentially can effect hemodynamics.      In order to avoid hemodynamic changes proper and routine monitoring is recommended.   "
152507|NCT01287559|"     The investigators are studying a disease called necrotizing enterocolitis (or NEC for     short), which affects premature infants. It is the most common surgical emergency involving     neonates admitted to Newborn Intensive Care Units. Currently, clinicians are unable to     identify which infants will go on to develop NEC before they become ill. Clinical signs of     illness occur relatively late in the course of the condition, making NEC more difficult to     treat. The investigators will test a new probe that uses safe levels of visible and infrared     light, with and without ultrasound imaging, to see if the investigators can identify infants     before they get sick using a simple, noninvasive test, This test will be repeated through at     least one feeding (which stresses the gut) each day. If successful, the health benefit will     be large, as it is estimated that treating NEC alone (not including treating its later     complications) adds $650 million to the annual health bill.   "
152508|NCT01287546|"     The objective of this study is to determine a recommended Phase 2 dose range of LY2875358     that may be safely administered to participants with advanced cancer. In Part A and Part A2     of this study, escalating doses of LY2875358 as monotherapy and in combination with erlotinib     will be evaluated for safety and tolerability, respectively. Part B is a dose-confirmation     segment for LY2875358 therapy in 5 different types of cancer: nonsquamous non-small cell lung     cancer (NSCLC), castrate resistant prostate cancer (CRPC) with bone metastases, renal cell     carcinoma (RCC), hepatocellular carcinoma (HCC), or uveal melanoma with liver metastases, and     for LY2875358 in combination with trametinib in participants with uveal melanoma with liver     metastases.   "
152509|NCT01287533|"     This study was to investigate the efficacy of oral monthly ibandronate in the management of     glucocorticoid induced osteoporosis in women with rheumatoid arthritis.   "
152510|NCT01287520|"     The purpose of this study is to determine a recommended Phase 2 dose and dosing regimen of     LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic     cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B     will consist of an expanded cohort to confirm the dose provided from Part A.   "
152511|NCT01287507|"     The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin     (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis     and the effect of LF on regulatory T cells.   "
152512|NCT01287494|"     Using a randomized controlled design, the investigators will examine whether the DCM is an     effective treatment for patients with late life depression in urban China. Our specific aims     are: (1) to determine whether the DCM intervention results in improved outcomes compared with     CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels     (e.g., greater reduction in depressive symptoms); and (2) to compare DCM with CAU with regard     to a range of outcomes in other pertinent domains, both at the provider (e.g., improvements     in knowledge/attitudes) and patient (e.g., functioning, satisfaction) levels. The study will     take place in 16 primary care clinics (PCCs) randomly assigned to deliver either DCM or CAU     (8 clinics each) to 320 patients (aged≥60 years) with major depression (20/clinic; n=160 in     each treatment condition). In the DCM arm, PCPs will prescribe 16 weeks of antidepressant     medication according to the TG protocol. CMs monitor the progress of treatment and side     effects, educate patients/family, and facilitate communication between providers;     psychiatrists will provide weekly group psychiatric consultation and CM supervision. Patients     in both DCM and CAU arms will be assessed by clinical research coordinators at baseline, 4,     8, 12, 18, and 24 months. HDRS, MMSE, CAS, SF-12, Treatment Stigma and the Client     Satisfaction Questionnaire will be used to assess patients' outcomes; and clinic practices,     attitudes/knowledge, and satisfaction will be providers' outcomes.   "
152513|NCT01287481|"     This interventional, randomized controlled study seeks to test the effects of an innovative     emotional exposure and processing treatment that targets stress resolution, by comparing it     with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The     investigators also will test proposed mediators of the intervention, including improved     autonomic regulation, and explore which subgroups of patients benefit the most from each     approach.   "
152524|NCT01287338|"     The purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms     (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model.   "
152525|NCT01287325|"     This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients     with COPD and cough.   "
152514|NCT01287468|"     Over the past five years, a spectrum of studies has shown that the stromal cell populations     surrounding or embedding cancer cells in a variety of different tumor types are intrinsically     involved in the mechanisms affecting tumor growth and metastasis. Among these cells,     fibroblasts and myeloid derived suppressor cells (MDSCs) have been shown to play key roles in     the regulation of tumor cell behaviors, via differential gene expression, regulation and     secretion of specific chemokines (e.g., RANTES, CXCL12 and CXCL14), cytokines (e.g., TNF-α,     IL-1β, NF-κB) and control by inflammatory and immunomodulatory cells, molecules or potent     growth factors. Of particular interest is that the various stromal immune cells (dendritic     cells and T cells) and inflammatory MDSCs found in primary and metastatic tumors behave very     differently from those present in normal or non-cancerous counterpart tissues. In light of     these new understandings in cancer biology, the investigators believe that systematic and     innovative approaches to further research are very much needed in Taiwan and at our Academy.     Here the investigators propose to investigate the tumor suppressive effect of     anti-inflammatory phytomedicines on regulation of stromal immune cells and fibroblasts in     breast cancers. The investigators will employ the TS/A and 4T1 mouse mammary carcinoma system     to conduct an in vivo study of several specific candidate phytomedicines (cytopiloyne,     Wedelia chinensis, shikonin, emodin and others that the investigators have already identified     as conferring anti-inflammation related activities) for inhibition of TS/A and 4T1 tumor     growth and specific effects on inflammation-associated, cellular and molecular functions of     stromal immune cells, fibroblasts and MDSCs. When potent and specific anti-tumor effects are     detected, the investigators will extend our study to a three-dimensional collagen/Matrigel     culture system for ex-vivo study focusing on the stromal cell-mediated or -associated     anti-tumor effects of TS/A or 4T1 cells, using the organoid tissue culture systems the     investigators have previously developed in our laboratory (JNCI, 1979; Cancer Res., 1981).     The investigators will establish reconstituted TS/A or 4T1 tumor cells with the stromal     immune cells in a co-cultivation system. When the investigators have achieved demonstrable     success, the investigators will extend the mouse system to human breast cancers (including     primary and metastatic tumors) by a close collaboration (which the investigators have already     established) with Drs.   "
152515|NCT01287455|"     Research Title: The effect of vitamin D replacement on airway reactivity, allergy and     inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic     children.      Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions as an     immunomodulator. Asthma disease involves inflammatory process in the lower respiratory tract     and airway hyperreactivity.      Aim: To assess the effect of Vitamin D replacement on airway reactivity, and allergy and     inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic     children.      Design: Double blind placebo control prospective study comparing the effect of Vitamin D     replacement and placebo on airway reactivity, allergy and inflammatory mediators in exhaled     breath condensate in asthmatic pediatric population with vitamin D deficiency.      Participant selection: The study group will consist of pediatric patients (age 6-18 years)     followed and treated at the Pediatric Pulmonary Unit at the investigators hospital.      Patients with mild-moderate asthma with low or insufficient vitamin D levels that are     currently not receiving anti-inflammatory treatment will be recruited.      Sample size: 60 participants in the two groups (30 receiving Vitamin D and 30 receiving     placebo).      Intervention: Vitamin D (14000 units) or placebo will be provided in a similar appearance     preparation once weekly for 6 weeks between visit two and three.      Three visits will be conducted. Each subject will undergo evaluation including a respiratory     questionnaire (visit 1), methacholine challenge test with determination of PC20 (visit 1 or 2     and visit 3), exhaled nitric oxide (eNO) (visit 2, 3), and exhaled breath condensate (EBC)     (visit 2,3). Venous blood will be analyzed for complete blood count + eosinophils (visit 1,     3), IGE levels (visit 1, 3), and Vitamin D levels (visit 1, 3). Prick skin test for inhaled     allergens will be performed (visit 2, 3).      Primary end point: Airway reactivity as assessed by methacholine challenge test.      Secondary outcome parameters: All other parameters are the secondary end points.   "
152516|NCT01287442|"     It is well established to assess the functionality of a filtering bleb by intraocular     pressure (IOP), either as an absolute value or as a percent reduction, and by the need of     additional antiglaucoma drugs. It is also possible to evaluate the appearance of a bleb by a     clinical score, e.g. the Wuerzburg bleb classification score (WBCS). The purpose of this     study was to find out whether there is a correlation between clinical findings, in particular     IOP and the WBCS.      100 eyes within two years after trabeculectomy were included into the study. Using colour     photographs the filtering bleb was evaluated according to the WBCS from two different     examiners, both on different levels of clinical experience. WBCS = 1 indicates poor bleb     appearance, WBCS = 15 indicates optimal bleb appearance. At the same time, clinical findings     like intraocular pressure, best corrected visual acuity, slit lamp biomicroscopy and medical     history were taken by another examiner.        -  Trial with surgical intervention   "
152517|NCT01287429|"     Dyspnea is a frequent symptom in patients admitted to the Emergency Department (ED);     discriminating between cardiogenic and non-cardiogenic dyspnea is a common clinical dilemma.     The initial diagnostic work-out is often not very accurate in defining the etiology and the     underlying pathophysiology. In the last years, lung ultrasound (US) has emerged as a useful     real-time bedside diagnostic tool in the critical patient. The aim of this study was to     evaluate the accuracy, reproducibility, and diagnostic impact of pleural and lung US,     performed by emergency physicians at the time of patient first presentation to the ED, in     identifying cardiac causes of acute dyspnea.   "
152518|NCT01287416|"     Primary Hypothesis: Participants in the Applied Suicide Intervention Skills Training (ASIST)     gatekeeper training will be significantly more likely to have increased knowledge and     preparedness to help people with suicidal ideation than participants who receive the     resilience retreat.      Secondary Hypotheses:        1. Participants in ASIST gatekeeper training will not have higher levels of          post-intervention distress or suicidal ideation compared to the resilience retreat.        2. High levels of distress, grief, and alcohol abuse will significantly impact on the          learning and retention of suicide intervention skills.   "
152519|NCT01287403|"     Cereal grains contain a wide variety of different phytochemicals which may play different     roles in physiology. Their response in plasma and urine after a meal is poorly defined for     most cereals. This study will investigate the plasma response and urinary excretion of cereal     compounds after eating 6 different types of cereal preparation, with a focus on     alkylresorcinols.   "
152520|NCT01287390|"     Severe acute and late dysphagia is now considered as a dose-limiting toxicity of     radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of     life. We propose to preserve swallowing function by:        -  adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to          per-treatment changes occurring in the tumor and surrounding organs and tissues;        -  reducing the volumes of elective neck, that may result in significant decrease of severe          acute and late dysphagia.   "
152521|NCT01287377|"     The primary purpose of this study is to test the feasibility of sending pre-cessation     nicotine patches and to examine the effects associated with the pre-cessation treatment     phase. Specifically, this study aims to:        1. See if subjects will use pre-cessation nicotine patches.        2. See if subjects in the pre-cessation nicotine patches go on to get more nicotine          patches.        3. See if pre-cessation treatment with nicotine patches leads to a decrease in number of          cigarettes smoked per day.        4. See if sending 2-weeks' worth of patches is helpful to the quitting process.   "
152522|NCT01287364|"     This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or     older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a     novel-patient administered assessment of treatment satisfaction with and preference of an     Internasal Corticosteroid (INCS)   "
158278|NCT01211951|"     The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to     placebo in patients with dry eye syndromes.   "
152526|NCT01287312|"     Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure.     Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported     with a good results ( 4 cases). There were no serious advers effects.      The investigators want to use also TCA 50% for endoscopic repair in children with recurrent     TEF.   "
152527|NCT01287299|"     The purpose of the study is to determine if a low glycemic load diet reduces the gain of body     fat and insulin resistance during the last half of pregnancy in obese women.   "
152528|NCT01287286|"     The purpose of this study is to investigate if food supplements,Antrodia cinnamomea, could     minimize the gastrointestinal symptom of cancer patients with chemotherapy.   "
152529|NCT01287273|"     Frozen- thawed embryos obtained by IVF treatments are transferred to the uterus immediately     following thawing or after incubation for additional 24-72 hours. The two methods are routine     in IVF laboratories. In this study the investigators would like to compare between these two     methods in terms of implantation rate, pregnancy rate and delivery.   "
152530|NCT01287260|"     This is a clinical study evaluating the superiority in efficacy and assess safety and     tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with     BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who     are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.   "
152531|NCT01287247|"     This is a prospective, observational trial evaluating the real world use of     Xeomin®(incobotulinumtoxinA). Physicians may enroll patients who are eligible to be treated     with a botulinum toxin for cervical dystonia or blepharospasm based upon their clinical     experience. The physician must have chosen to treat the patient with Xeomin®     (incobotulinumtoxinA) prior to and independent of enrollment in this study. Physicians may     choose to treat their subjects with up to 2 treatment cycles (approximately 6 months/subject)     of Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her     clinical experience with botulinum toxin. According and dependent on clinical practice, the     investigators expect that subjects will be seen by the investigator for an average of 3     visits (two treatment cycles).   "
152532|NCT01287234|"     The purpose of this study is to evaluate an external device (SonR sensor) that is capable of     detecting sounds created by the heart (SonR signal). Based on the sounds created by the heart     and recorded by the SonR sensor, optimal timing settings for the cardiac resynchronization     therapy defibrillator (CRT-D) device may be determined. The investigators will then compare     the timing settings suggested by SonR to the settings suggested from the echocardiogram. The     objective of this study is to determine if differences exist between these different methods     of timing the contractions of the top and bottom chambers of the heart and if the SonR signal     is able to produce results similar to those of an echocardiogram.   "
152533|NCT01287221|"     The purpose of this study was to determine whether Rifampicin was effective in slowing or     reversing the progression of multiple system atrophy (MSA). Research studies indicate that     there is an abnormality in protein synthesis and structure in parts of the brain responsible     for MSA (protein misfolding) and the drug Rifampicin could potentially prevent or reverse     this protein alteration. The study was done on participants with early MSA. The study     consisted of taking the drug 2 times a day for 12 months. Participants underwent an     evaluation of symptoms and function and will underwent a neurologic examination at the     beginning of the study, at 6 months and at 12 months. They were also be contacted at 3 and 9     months by telephone. Studies were done at 10 participating sites.   "
152534|NCT01287208|"     The main objective of this study is to test an intervention to increase the physical activity     of medical residents, an employee population with little time for exercise. Specifically, the     aims of this study are:        1. To determine if providing medical residents with an activity device that measures steps,          distance, and calories burned and tracks this information over time on a website          increases residents' physical activity levels as measured by number of steps per day          compared to a control group using a blinded activity device (no feedback).        2. To determine if an unblinded team competition using the activity device directly          following the randomized phase increases residents' activity level compared to baseline.        3. To determine if activity level is associated with change in weight during the residency          year.        4. To determine if the average hours of sleep per week is associated with changes in weight          and with activity level.   "
152535|NCT01287195|"     This study will assess the safety and efficacy of orally delivered short-term OKT3 in     participants with active ulcerative colitis.   "
152536|NCT01287182|"     This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness     in Assessing the Risk Factors of Atherosclerosis.   "
152537|NCT01287169|"     We intend to conduct a pilot study designed to measure BPA levels before and after     occupational exposure to thermal paper used in cash registers. We will recruit cashiers from     a local commercial store that is currently still using BPA-laden thermal paper and plans to     switch to BPA-free paper in the near future. The study uses a within-subject comparison     design, using serum and urine samples to determine whether BPA is detectable in the study     population at sufficient levels to measure differences in paired samples. Two phases of     sample collection are proposed: Phase I - collecting paired samples on two separate occasions     before the implementation of BPA-free thermal paper use in cash registers; and Phase II -     collecting paired samples on two separate occasions after the implementation of this change     in thermal paper.   "
152564|NCT01286818|"     The primary objective of this study is to investigate the safety and tolerability of the     anti-vascular endothelial growth factor receptor-2 (anti-VEGFR-2) monoclonal antibody     Ramucirumab (IMC-1121B) in combination with irinotecan, levofolinate, and 5-fluorouracil     (FOLFIRI) in Japanese participants with advanced colorectal carcinoma (CRC).   "
152565|NCT01286805|"     The purpose of this study is to determine whether the use of a lumbar plexus block for     arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in     treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the     total amount of pain medication needed, and therefore reduce the side effects of these     medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar     plexus block will significantly reduce patients' postoperative pain.   "
159962|NCT01189760|"     This study will evaluate the safety and efficacy of botulinum toxin Type A compared to     placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)   "
152568|NCT01286753|"     This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib     (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC)     positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants     will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or     unacceptable toxicity occurs.   "
152569|NCT01286740|"     The purpose of this Phase 2b study was to evaluate the efficacy and safety of the     emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching     from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA < 50 copies/mL at     Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months     prior to study start, were experiencing safety or tolerability concerns (in particular,     EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.   "
152570|NCT01286727|"     The objective of the study is to evaluate the safety and activity of a investigational drug     in improving renal function in patients who have undergone renal transplantation and have     signs and symptoms of significant renal injury and are at risk for dialysis.   "
152745|NCT01284439|"     To study effect of hydroxypropylmethylcellulose 0.3% and sodium hyaluronate 0.18% in the     treatment of ocular surface disease in glaucoma patients.   "
152538|NCT01287156|"     Background:      - The Center for Neuroscience and Regenerative Medicine is working to improve physicians'     understanding of brain injury. More information is needed on traumatic brain injury (TBI),     especially how well a person recovers from TBI and how the brain changes over time in people     with TBI. To conduct this research, the center is sponsoring a number of research studies on     TBI and is interested in evaluating individuals with TBI or post-concussive syndrome to     determine if they might be eligible for future studies.      Objectives:      - To develop a pool of individuals with traumatic brain injury and post-concussive syndrome     for future research studies.      Eligibility:      - Individuals at least 18 years of age who have symptoms of or have been diagnosed with     traumatic brain injury or post-concussive syndrome and are willing to participate in future     studies.      Design:        -  Participants will be screened with an initial telephone interview, and will be asked to          come to the National Institutes of Health for an in-person screening visit.        -  At the screening visit, participants will provide a medical history, have a physical          examination and complete a study questionnaire on their TBI and its symptoms, including          how the injury occurred, when it occurred, and any previous brain-related injuries.        -  Subjects may also return for a second visit at the NIH CC if eligible.        -  Each visit may involve blood samples, an MRI scan, and a series of tests to evaluate          brain function.        -  Participants will also provide contact information to enable researchers to contact them          for future studies.   "
152539|NCT01287143|"     Background:      - Fever is a common symptom of illness, but it can involve many signs (a signal that     something is not right in the body that can be seen by others, such as vomiting) and symptoms     (a signal that something is not right in the body that are felt only by the person, such as     pain) that may differ depending on the type of illness involved. Researchers are interested     in studying individuals who have a fever to examine how often these signs and symptoms are     experienced by patients.      Objectives:      - To identify and evaluate the signs and symptoms of fever and examine their frequency in     individuals who have fever.      Eligibility:      - Individuals at least 8 years of age who are admitted to the NIH Clinical Center and have a     fever (body temperature of at least 38 degrees Celsius/100.4 degrees Fahrenheit).      Design:        -  Participants will be screened upon admission to the NIH Clinical Center.        -  Researchers will review the Clinical Center admission records.        -  Participants will complete a 15- to 20-minute survey with questions about how they are          feeling and what symptoms they have experienced before, during and after an episode of          fever.   "
152540|NCT01287130|"     Background:      - The experimental cancer treatment drug AZD6244 has been shown to block signals that tell     cancer cells to grow. Cetuximab, a drug approved to treat cancer of the head, neck, colon,     and rectum, also blocks signals that tell cancer cells to grow. Researchers are investigating     the highest safe dose of AZD6244 to give with cetuximab, and will also investigate the     effectiveness of this drug combination in individuals who have colorectal cancer that     involves a particular protein known as the K-RAS protein. Cetuximab is not used to treat     colorectal cancer with K-RAS tumors because it has not been shown to be effective, but     researchers believe that adding AZD6244 to cetuximab may improve how well cetuximab works,     even in people with K-RAS tumors.      Objectives:        -  To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for          solid tumors that have not responded to standard treatment.        -  To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for          colorectal cancer that involves the K-RAS protein and has not responded to standard          treatment.      Eligibility:        -  Individuals at least 18 years of age who have been diagnosed with solid tumors that have          not responded to standard treatment.        -  Individuals at least 18 years of age who have been diagnosed with colorectal cancer that          has not responded to standard treatment.      Design:        -  This protocol will involve two separate studies: an initial study to establish the          highest safe and effective dose of AZD6244 and cetuximab in individuals with solid          tumors, and an expansion study of AZD6244 and cetuximab in individuals with colorectal          cancer involving the K-RAS protein.        -  Participants will be screened with a full medical history and physical examination,          blood samples, imaging studies, and other tests as required by the researchers.        -  AZD6244 is a capsule to be swallowed once or twice a day, every day, with water on an          empty stomach. Cetuximab will be given intravenously once a week, over 2 hours for the          first dose and over an hour for every following dose. This combination of daily AZD6244          and weekly cetuximab will be repeated in 28-day cycles of treatment. Participants will          keep a diary to record the time of taking AZD6244 each day, as well as any side effects.        -  Participants will have frequent blood tests and other exams during the first cycle of          treatment, up to five visits to the National Institutes of Health (NIH) and other visits          to their local doctor to in the first 28-day cycle.        -  During subsequent cycles, participants will have four visits to NIH and four visits to          your local doctor for examinations, blood tests, and imaging studies.        -  Participants may continue to receive the AZD6244 with cetuximab for up to 6 cycles,          until the tumor grows, unacceptable side effects development, or the participant or          participant's doctor decides to stop participation. There will be a final study visit          that repeats the procedures performed during the screening visit....   "
152541|NCT01287117|"     The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled,     parallel-group study to evaluate the efficacy and safety of omalizumab administered     subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged     12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite     standard-dose H1 antihistamine treatment.   "
152542|NCT01287104|"     Background:        -  Bone marrow stem cells, which are found in the bone marrow and blood stream, can be          collected and transplanted to treat a variety of types of cancer in a process known as          hematopoietic stem cell transplantation (HSCT). When stem cells are taken from one          person, most commonly a sibling or a family member, and then given to another person,          this is referred to as allogeneic HSCT. Allogeneic HSCT has proven to be an especially          effective treatment for patients with some types of cancers of the blood (leukemia) and          certain solid tumors. The transplanted stem cells travel to the patient's bone marrow          and begin producing normal blood cells, and also attack patient s cancer cells.        -  Because allogenic HSCT does not always prevent the cancer from returning, researchers          are interested in determining whether another type of immune cell taken from the stem          cell donor s white blood cells, called a natural killer (NK) cell, can be given in          addition to the HSCT to help fight the tumor. In the laboratory, NK cells have been          shown to kill tumor cells, but it is not yet know if this will occur when given to          patients after HSCT.      Objectives:        -  To determine the safety, effectiveness, and immune system response of giving NK white          blood cells to individuals who have received allogeneic HSCT.        -  To identify possible side effects from the treatment.      Eligibility:        -  Donors: Stem cell donors whose blood matches one of the recipients on six out of six HLA          (blood immune marker) types. The donor may not be the identical twin of a recipient.        -  Recipients: Individuals between 4 and 35 years of age who have been diagnosed with          pediatric solid tumors that have not responded to standard treatment, or individuals          between 4 and 18 years of age who have been diagnosed with leukemia that has not          responded to standard treatment.        -  Other eligibility requirements which include a physical exam and blood laboratory          evaluation are included to make sure it is safe for both the donor to donate and the          recipient to undergo the transplant procedure.      Design:        -  Donors and recipients will be screened with a full medical history and physical          examination, and will provide blood and urine samples; recipients will have tumor          imaging studies and other tests as required by the researchers.        -  Donors:        -  Participants will receive filgrastim injections (to stimulate the bone marrow) for 1          week to make stem cells travel from bone marrow to blood.        -  Participants will provide stem cells and NK cells through apheresis.        -  Recipients:        -  Participants will have three cycles of chemotherapy to treat the underlying cancer and          weaken the immune system so that it will accept the donor cells.        -  Participants will then receive preparative chemotherapy for the transplant and two days          after the last dose of chemotherapy, participants will have allogenic HSCT using the          donated stem cells.        -  Participants will receive an infusion of NK cells on days 7 and 35 after the HSCT. -          Participants will remain in the hospital for monitoring after the HSCT and NK cell          treatments, and will be followed closely as outpatients for the first 6 months after the          transplant and then less frequently for at least 5 years.   "
152543|NCT01287091|"     This will be a single-center, open-label, 3 part study. The study is designed to determine     the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting     conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980     tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the     presence or absence of a high-fat meal.   "
152734|NCT01284582|"     Phase 1 Study :Safety, Immunogenicity and Dose response of ATH03, a new vaccine against the     cholesterol ester transfer protein (CETP), in healthy male subjects with high density     lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl.   "
152544|NCT01287078|"     Background:      - Bronchiolitis obliterans or bronchiolitis obliterans syndrome is a lung disorder that     occurs as a complication of either lung transplantation or bone marrow/blood stem cell     transplantation. In bronchiolitis obliterans, the body s white blood cells or white blood     cells from the transplant attack the lungs, which leads to the destruction of lung tissue,     and ultimately, scarring or fibrosis of the lung tissues. When a patient develops fibrosis of     the lungs or bronchioles, the lungs no longer work properly, which causes difficulties with     breathing that lead to a diminished quality of life and an increased risk of death. Treatment     typically involves immunosuppressive therapy such as oral cyclosporine or steroid therapy,     but these treatments are only marginally effective and can cause significant toxicities and     increase the risk of infections. Inhaled cyclosporine (CIS) achieves higher concentrations of     cyclosporine in the lungs and lower concentrations of cyclosporine in the blood than oral     cyclosporine. Therefore, it could have advantages over conventional oral immunosuppressive     therapies used to treat this disorder. Researchers are interested in testing whether inhaled     cyclosporine therapy could be used as a safe and effective treatment for bronchiolitis     obliterans or bronchiolitis obliterans syndrome occurring after bone marrow/blood stem cell     or lung transplants.      Objectives:      - To evaluate whether inhaled cyclosporine (CIS) can improve or stabilize lung function and     quality of life in individuals with bronchiolitis obliterans.      Eligibility:      - Individuals between 10 and 80 years of age who have been diagnosed with bronchiolitis     obliterans or bronchiolitis obliterans syndrome after blood or lung transplants.      Design:        -  Participants will be screened with a full medical history and physical examination, as          well as blood and urine tests, lung function tests, imaging studies, and quality of life          questionnaires.        -  Participants will take cyclosporine inhalation solution through a nebulizer. The          nebulizer generates a mist of cyclosporine inhalation solution (CIS), which is then          breathed in through a mouthpiece. The process takes approximately 20 minutes. The          solution will be provided in single-use vials.        -  Participants will continue to take all medications for post-transplant care as required          by their doctor and the study researchers. Attempts will be made to reduce the doses and          types of immunosuppressants given to participants on the study, as long as the treatment          continues to produce improved or stable lung function.        -  Participants will have study visits every 3 weeks with blood and urine tests, lung          function tests, and imaging studies. Participants will also complete quality of life          questionnaires as directed. Treatment will continue for a minimum of 18 weeks, followed          by a final follow-up visit 2 weeks after the end of the study.        -  Participants who benefit from the inhaled cyclosporine (CIS) may continue to receive          further therapy with inhaled cyclosporine at the end of the study by participation in a          separate study extension.   "
152545|NCT01287065|"     This study will be a repeat-dose, double-blind, randomized, placebo controlled, three-way     crossover study in patients with persistent bronchial asthma to compare the effect of morning     (AM) and evening (PM) dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder     on lung function. Following screening there will be a run-in period of 14 days. There will be     3 treatment periods; drug at AM, drug at PM and placebo, which will last for 14 days each     with a 14-21 day washout period between starting the next. Key assessments include; forced     expiratory volume in one second (FEV1), peak expiratory flow (PEF), vital signs,     electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests.   "
152546|NCT01287052|"     BACKGROUND Migraine headaches account for 8-18% of all headaches seen in pediatric emergency     rooms. Standard treatment includes IV pain medications, anti-emetics, and IV fluids. Nitrous     oxide has analgesic properties similar to those of opioids and is easy to administer. It has     been shown in two small studies to be effective in treating migraine headaches.      RESEARCH QUESTION Does nitrous oxide act as a safe, less invasive, and effective treatment of     acute migraine headaches in children and adolescents presenting to an Emergency Department?      DESIGN This is a prospective non-randomized self-controlled study. Repeated measures will be     taken to examine change in pain scores before and after nitrous oxide treatment.      METHODS Each participant will be given nitrous oxide until he/she reports a pain score of     zero or up to fifteen minutes. Study subjects will be asked to rate their pain on a scale of     0-10 before the treatment and after the treatment at multiple time-points.   "
152547|NCT01287039|"     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group     study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in     patients with eosinophilic asthma.   "
152548|NCT01287026|"     Background:      - Currently, heart catheterization procedures are guided by X-rays. Researchers are     developing new techniques to perform heart catheterization without the use of X-rays by     investigating possible uses of magnetic resonance imaging (MRI) scans. To study these uses,     researchers are interested in performing a part of the standard X-ray catheterization     procedure using MRI on individuals who are scheduled to have heart catheterization.      Objectives:      - To examine the safety and feasibility of right-heart catheterization using MRI-guided     catheters.      Eligibility:      - Individuals at least 21 years of age who are undergoing a medically necessary heart     catheterization procedure.      Design:        -  The research MRI procedure will be performed either before or after standard X-ray          guided heart catheterization.        -  Participants will be transferred from an X-ray table onto an MRI table and advanced into          the scanner. Under MRI guidance, a MRI-compatible catheter will be used to measure blood          pressure and blood oxygen levels in the heart, and MRI scanning will be performed for          approximately 30 minutes.   "
152549|NCT01287013|"     Background:      - Procedures that use medical tools in or near a possible abnormality in the body often use     computed tomography (CT) scans to locate the abnormality and guide the path that a needle     will take to collect a sample of tissue. Xperguide and electromagnetic (EM) tracking are two     new procedures being studied to help guide the needle. Xperguide is software that uses CT     images to help the doctor choose the needle path. EM tracking uses special medical tools with     miniature coils that act like a GPS device to show the location of the needle in the body.     Xperguide and EM tracking have been used in humans and have good results, but they have not     been compared with each other and regular CT to determine whether they are better than the     standard approach.      Objectives:      - To compare the results of Xperguide, electromagnetic tracking, and regular computed     tomography during a guided percutaneous procedure.      Eligibility:      - Individuals at least 18 years of age who are required to have a CT-guided percutaneous     procedure.      Design:        -  Participants will be screened with a physical examination and medical history, and the          results of any previous imaging studies will be examined before study enrollment.        -  After a pilot phase, the study will involve two phases to compare the results of the          different procedures. The first phase will involve comparing Xperguide to CT, and the          second will involve comparing Xperguide to EM tracking.        -  Phase 1 participants will be assigned to one of two procedure groups: Group 1 will have          Xperguide, and Group 2 will have regular CT. Participants who are scheduled to have          repeated procedures (like a biopsy before and after chemotherapy) will be randomized for          the first procedure and the second procedure will be done using the other method.        -  Phase 2 participants will be assigned to one of two procedure groups: Group 1 will have          Xperguide, and Group 2 will have EM tracking. Participants who are scheduled to have          repeated procedures (like a biopsy before and after chemotherapy) will be randomized for          the first procedure and the second procedure will be done using the other method.        -  Standard post-procedure followup care will be given after the study procedure is          completed.   "
152566|NCT01286779|"     The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery     over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of     life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately     severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric     study 251101.   "
152567|NCT01286766|"     Number of patients planned The study adopted two parallel phase II studies, with the same P1     and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of     interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively.     Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26     patients were required per arm to achieve the desired statistical power. Finally, taking a     20% drop-out rate into consideration, the overall number of enrolled patients was 62.   "
152735|NCT01284569|"     The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the     receptor for interleukin 6 (IL6R), is safe and effective after single or multiple     administrations to patients with rheumatoid arthritis (RA). Patients will receive different     single or multiple doses of either placebo or ALX-0061.   "
152550|NCT01287000|"     Background:        -  There has been little research on the long-term health effects from oil spills, even          though at least 10 percent of all oil tanker spills between 1970 and 2009 have affected          coastal populations. The Deepwater Horizon disaster, with its release of approximately 5          million barrels (~680,000 tons) of crude oil into the Gulf of Mexico, is far larger than          any of the individual tanker spills. Given the magnitude of this spill and the scope of          the potential exposures, including the 55,000 workers involved in clean-up efforts and          countless residents of the affected areas, researchers are interested in monitoring Gulf          clean-up workers to understand the adverse consequences of oil spills in general.        -  The Gulf Long-term Follow-up Study will investigate health effects associated with the          clean-up activities following the Deepwater Horizon disaster in the Gulf of Mexico on          April 20, 2010. More than 100,000 persons completed safety training in preparation for          participation in clean-up activities related to the spill. Many of these individuals          participated in active clean-up efforts, but others did not. Exposures among persons          involved in clean-up range from negligible to potentially significant, especially for          workers involved in tasks associated with direct exposure to crude or burning oil, or to          chemical dispersants. However, prediction of adverse health effects is not possible          because the long-term human health consequences of oil spills are largely unknown. In          addition to the oil itself, the widespread economic and lifestyle disruption caused by          the oil spill may contribute to mental health problems among this population.      Objectives:      - To investigate potential short- and long-term health effects associated with clean-up     activities and exposures surrounding the Deepwater Horizon oil spill.      Eligibility:      - English-, Spanish-, and Vietnamese-speaking workers and volunteers at least 21 years of age     engaged or potentially engaged in oil spill clean-up operations in the Gulf of Mexico, or who     lived in affected areas (Louisiana, Mississippi, Alabama, and Florida coastal regions).      Design:        -  Participants will be divided into groups of those who performed oil-spill          clean-up-related work ( exposed ) and those who did not engage in clean-up-related work          ( unexposed controls).        -  Participants will be screened with a full medical history and physical examination, as          well as an interview to determine the nature of their potential exposure.        -  Participants will provide blood, hair, toenail, urine, and saliva (spit) samples.          Participants may also have a lung function exam.        -  Participants will have researchers collect dust from their homes by using wipes and          special vacuum bags.        -  Participants will also provide detailed contact information, including their Social          Security number, to be contacted in the future for long-term health follow-up          appointments. These appointments will include 30-minute telephone interviews every 2          years.   "
152551|NCT01286987|"     This is a single-arm, open-label study to assess the safety, pharmacokinetics,     pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors     with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation     phase in which the maximum tolerated dose will be defined, and a dose expansion phase.   "
152552|NCT01286974|"     A pharmacokinetic study to access how the body absorbs and removes linifanib in male patients     with advanced solid tumors.   "
152553|NCT01286961|"     As the duration of the interval between the time of last preparation-agent dose and the start     of the colonoscopy is increasing, the quality of bowel preparation will be worse.   "
152554|NCT01286948|"     It has been proposed that levonorgestrel (LNG) in a vaginal gel could be used as an 'on     demand' contraceptive when used before coitus. Levonorgestrel was selected as it is a     component of many approved oral contraceptive pills and also it is the active agent in Plan     B, an FDA-approved regimen for emergency contraception (EC). In previous studies it was     demonstrated that an LNG vaginal gel was absorbed and was effective in preventing follicular     rupture. The overall proportion of cycles with lack of follicular rupture within 5 days of     LNG administration or with ovulatory dysfunction (follicle rupture preceded by an inadequate     LH surge) was 96% for LNG gel and 39% in the inert gel cycles (control group).   "
152555|NCT01286935|"     The purpose of this study is to determine the long-term efficacy and safety of two doses of     safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with     idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable     dose of levodopa.   "
152556|NCT01286922|"     The Insulin Sensitivity using Aerobic Interval Conditioning (ISAIC) trial will compare     traditional aerobic training (AER) to interval training (INT) in sedentary, overweight/obese     men at risk for pre-diabetes. The investigators will randomly assign 42 individuals to 3     months of monitored exercise using a randomly assisgned design where participants will     exercise under either AER or INT training conditions. The AER training condition will be     consistent with standard-of-care recommendations. Exercise training will entail one 3-month     blocks of either AER or INT. Training will consist of 1) a 1-month ramp up period, 2) 1-month     of traditional aerobic training and 3) 1-month of either continued AER or INT.   "
152557|NCT01286909|"     A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in     Lowering Triglycerides and Raising High-Density Lipoprotein (HDL).   "
152558|NCT01286896|"     The purpose of this prospective study is to determine the safety and feasibility of     pharmacokinetically (PK) guided dosing of sunitinib in 30 patients.      At day 15 ± 1day, day 29 ± 1day and after 8 weeks ± 1day of sunitinib treatment sunitinib and     SU12662 trough levels will be measured. Depending on the sunitinib and SU12662 trough levels     (and toxicity) dose adjustments will be made.   "
152559|NCT01286883|"     The study will enroll patients with metastatic colorectal cancer receiving chemotherapy. A     total of approximately 22 cc of blood will be drawn during various chemotherapy infusions.     Additional proposed laboratory studies may unravel important biological insights into the     relationship of circulating tumor cell genomic and genetic profiles as they compare to the     primary tumors. Additionally the investigators hope to gain an understanding of potential     subgroups of patients that have very high numbers of circulating tumor cells or those with     early relapse of circulating tumor cells after early reduction of circulating tumor cell     numbers.   "
152560|NCT01286870|"     While Core Becker patient follow-up is being completed this Continued Access Study is     designed to enroll patients at a limited rate per month to allow for continued physician and     patient experience with the device.      Up to 12 patients per month at sites across the United States will be enrolled in this     research study. These patients will be implanted with the Becker 25 or Becker 50     Expander/Breast implant and monitored for 10 years for safety.   "
152561|NCT01286857|"     The aim of the investigation is to evaluate the function of two new device parts to be used     in a NPWT system; an on-top suction device intended to transport exudate from the wound and a     silicon cover film intended to fixate the wound filler and seal tight to the skin in order to     keep a moist environment.   "
152562|NCT01286844|"     GSK2190915 is under development as an oral controller for the treatment of adult and     pediatric asthma. This study is an open label, single and repeat dose escalation study, in     children with asthma. It will investigate the pharmacokinetics of GSK2190915 in children,     aged from 1 to 12 years old inclusive, to determine how the dosage regimen for GSK2190915 in     a pediatric population should be adjusted to achieve approximately the same level of systemic     exposure that is safe and effective in adults.   "
152563|NCT01286831|"     The purpose of this study is to characterise the metabolic disposition of radiolabelled     GW642444 when administered orally.   "
152571|NCT01286714|"     Anastomotic fistula following bariatric surgery are lifethreatening complication with a 37.5%     mortality rate. All the modalities for bariatric surgery are involved in this type of     complication, but Sleeve gastrectomy is the main surgery responsible for the frequency and     the severity of the fistula. The management of this complication is still controversial and     potentially lethal. The average number of endoscopic sessions was 4 (range 2-11). The closure     could be obtained within a mean time of 88 days (range 6-216 days). Therefore endoscopic     management has to be improved to reduce the duration of the treatment and the number of     endoscopic sessions. OTSC clips could help to improve the endoscopic management because of a     more prehensive, deeper and larger suture area.   "
152572|NCT01286701|"     The purpose of this study is to compare the rate and extent of absorption of terbinafine     hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet     under fed conditions.   "
152573|NCT01286688|"     The purpose of this study is to compare the rate and extent of absorption of terbinafine     hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet     under fasting conditions.   "
152574|NCT01286675|"     Eltrombopag may improve the cell collection available for Autologous Stem Cell     Transplant(ASCT). The overall goal is to determine if adding Eltrombopag to the standard ASCT     will increase the number of blood cells collected and reduce the number of times blood needs     to be collected. This study will also determine the highest dose of Eltrombopag that can be     used without causing serious side effects.   "
152575|NCT01286662|"     The purpose of this study is to assess the long-term outcome in a cohort of Gardner-Syndrome     patients receiving prophylaxis and treatment for intestinal and non-intestinal tumors.   "
152576|NCT01286649|"     The primary purpose of this study is to assess the safety of performing injections of human     autologous hair follicle cells. The study will also measure the impact these injections will     have on hair growth.      20 patients will be selected for participation in this study (10 males and 10 females) based     on their health status, current/past medications, and ability to adhere to protocol-related     requirements. All patients will have evidence of mild to moderate androgenetic alopecia (AGA)     involving the vertex area of the scalp as defined by the Ludwig (female) or Norwood (male)     scales.      At the first visit and after completing informed consent, patients provide a blood sample     that will be tested for human immunodeficiency virus (HIV), hepatitis, and syphilis one week     before having a biopsy from the back of their scalp. The provided scalp biopsy is then     processed to isolate hair follicle cells which are then replicated. Patients return to the     clinic for injections of their own replicated cells (autologous cells) in medium (verum) and     medium alone (control) into two pre-selected treatment areas in their scalp. Assessments of     the safety/tolerability of these injections will take place over the next 60 months both at     in-clinic visits and telephone follow-up visits. At these visits patients will have their     overall health assessed as subjective and objective assessments of the areas that were     injected either with verum or control. During the first 24 months of follow-up, digital     images will be taken of the scalp and of the two treatment areas injected with either verum     or control. Furthermore at 6, 12, and 24 months post-injection, four patients (2 male and 2     female) at each time point will provide biopsies of the injection sites for histopathological     analysis. At the 60 month time point, any patients not previously providing biopsies for     histopathological analysis will provide biopsies. Total duration of patient participation is     approximately 63 months.   "
152577|NCT01286636|"     The investigators have developed a simple, accurate, and a point-of-care, computer-based     clinical decision support system (CDSS) not only to detect the presence of sleep apnea but     also to predict its severity. The CDSS is based on deploying an artificial neural network     (ANN) derived from anthropomorphic and clinical characteristics.      The investigators hypothesize that patients with severe OSA defined as AHI≥30 can be     diagnosed with the use of ANN without undergoing a sleep study, and that empiric management     with auto-CPAP has similar outcomes to those who undergo a formal sleep study.   "
152578|NCT01286623|"     The treatment of HIV and the tests performed for HIV care have changed over the last 20     years. However, improvement of management of HIV-infected subjects is still warranted,     especially as the HIV-infected population is aging. Therefore, this study will involve the     collection and analysis of clinical information obtained from subjects who are over 50 years     of age. For example, patients' risk of heart disease will be measured and monitored by     looking at blood tests and clinical data (such as blood pressure). This will allow     researchers to understand if the current way of assessing the risk of future heart disease is     the best one available for HIV-infected individuals. No genetic research will be done.   "
152587|NCT01286506|"     Dialysis is used to control the fluid balance and metabolic state of patients with kidney     disease. Control of the metabolic state, via electrolytes, can be monitored using labs that     are routinely drawn from patients undergoing continuous hemodialysis. Control of fluid     removal is much more difficult. This study aims to determine whether changes in the blood     pressure associated with breathing correlate with or predict intolerance to fluid     responsiveness with continuous dialysis.      We hypothesize that a measurement of changes in blood pressure with breathing called arterial     pulse pressure variation may be able to predict the ability to remove fluid during continuous     renal replacement therapy.   "
152588|NCT01286493|"     Booster rabies vaccination in HIV - infected patients who have ever received rabies primary     vaccination could improve their immune response to this kind of vaccine.   "
152736|NCT01284556|"     Primary:      - to evaluate the efficacy of phenobarbital in reducing seizure frequency.      Secondary:        -  to confirm dose response relationship,        -  to assess the effects on Type I seizures,        -  to assess the safety of phenobarbital        -  to assess the drug tolerability.   "
197445|NCT00432198|"     To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized     double blind-controlled trial   "
152589|NCT01286480|"     The objective of this study is to evaluate the potential role of a cardiology clinic-based     educational intervention for 15 to 17 year olds with congenital heart disease (CHD) and their     parents, and to determine whether this intervention results in improved self-management     skills (e.g., renewing medication prescriptions), teens having greater knowledge of their     heart condition, and more teen and parent satisfaction with services. The results of this     study will form the basis for a website that in turn may serve as an additional means of     providing transition interventions. The results of this study may also be applicable to youth     with other special health care needs.   "
152590|NCT01286467|"     This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on     select solid tumors.   "
152591|NCT01286454|"     This Is A Study Of Bioavailability And Food Effect For Fesoterodine.   "
152746|NCT01284426|"     The purpose of this study is to examine the natural history of chronic urticaria in children     and to identify the predictors for chronic urticaria remission.   "
152579|NCT01286610|"     Vibration therapy is used for different indications in rehabilitation and sports medicine. So     far, vibration therapy has not been investigated within the ICU setting. The investigators     created this setting to show safety and applicability of vibration therapy in ICU patients.     30 patients will be stimulated by vibration therapy on two separate days during their ICU     stay. Three collectives of equal size will be observed: One with patients on mechanical     ventilation without signs of infection or suspected intracranial pressure problems, a second     one with patients on mechanical ventilation in addition to signs of systemic inflammation but     absence of suspected intracranial pressure problems, and a third one with patients on     mechanical ventilation, signs of systemic inflammation in addition to presence of controlled     intracranial pressure problems. Typical parameters of hemodynamic status, intracranial     pressure and energy metabolism will be recorded for a defined period of time before, during     and after vibration therapy itself. Vibration therapy will be combined with protocol based     physiotherapy.      Our aim is to show the effects of vibration therapy in ICU patients and its safe     applicability.      ADDITION 06th of May 2011: Additionally we will perform euglycaemic hyperinsulinemic clamp     and intervention on one day of ICU stay in 20 patients. Under clamp conditions we will     perform a vibration therapy (ProMedVi Vibrosphere™) on patients' legs. On top we will perform     electrical muscle stimulation (schwa-medico, MUSKELaktiv™) on one ventral upper leg,     randomized chosen. Measuring the local skeletal muscle metabolism will be done by     microdialysis in Vastus lateralis on both sides - comparing vibration therapy and vibration     therapy combined with electrical muscle stimulation.   "
152580|NCT01286597|"     Lactose is a carbohydrate found in milk,and Lactase Deficiency (LD) is a condition in which     the small intestine cannot digest this carbohydrate due to absent or insufficient amounts of     lactase.Individuals with LD may be intolerant of lactose in the diet and experience abdominal     cramps, bloating and diarrhea; however the response is variable.Some tolerate moderate     amounts of lactose without adverse effect,whereas others experience severe symptoms in     response to even small doses. These problems may be representative of wider issues regarding     individual tolerance to diet containing ubiquitous poorly absorbed, fermentable carbohydrates     (such as: fructose, fructans)and be relevant to symptom generated in patients with diarrhea     predominant irritable bowel syndrome (D-IBS).      This project will investigate the effects of diet,lifestyle stress and psychiatric dietary on     the development of functional gastrointestinal symptoms. Lactose will be used to assess     tolerance to dietary challenge, a test that is particularly relevant in a Chinese population     with a high prevalence of lactase deficiency.   "
152581|NCT01286584|"     The aim of this study is to assess the efficacy of varenicline compared to placebo in tobacco     dependent individuals who are undergoing concurrent treatment for alcohol dependence. As they     will be inpatients and under 24 hour medical care for the first 21 days of treatment, or     receiving outpatient treatment through the Alcohol Research and Treatment Clinic, this will     allow for a comprehensive assessment of the safety of varenicline in this population with     minimal risk of adverse consequences. The patients will continue their cessation treatment     for an additional 10 weeks as outpatients through the Nicotine Dependence Clinic at CAMH.     They will also be contacted at 6 months for follow-up.   "
152582|NCT01286571|"     The objective of this study is to investigate the effect of food on the relative     bioavailability of a 50 mg BI 135585 XX tablet.   "
152583|NCT01286558|"     Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug     alone, often a combination of two or more drugs is essential to achieve a sufficient     antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination     therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low     dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the     Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination     (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure     (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with     T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.      In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood     pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination     was shown (U07-3503-02). But the sponsor has no data that verifies this difference in     Japanese patients.      Thus, this clinical trial is being conducted to investigate the antihypertensive effect and     safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients     with essential hypertension. In this trial, a multi-centre, randomised, double-blind,     double-dummy, active-controlled, parallel group comparison method is employed.   "
152584|NCT01286545|"     Long term data on efficacy and safety of anti-TNF treatment with infliximab in patients with     ankylosing spondylitis (AS) beyond 5 years is lacking. These data are important because     patients with AS usually are younger and withdrawal of anti-TNF therapy in these patients     almost always leads to a disease relapse. Furthermore it is still unclear whether long term     anti-TNF treatment in AS patients can inhibit radiographic progression. Patients who     participated in the EASIC and the DIKAS trial respectively who were treated with infliximab     within these studies for 7 and 10 years respectively are followed up by using clinical     outcome parameters every 6 months assessing efficacy and safety of long term treatment.     Furthermore radiographs of the spine, if done for clinical indication, are analyzed. It is     hypothesized that anti-TNF treatment with infliximab is effective and safe over a time period     of 9 and 12 years respectively and that long term anti-TNF therapy may inhibit radiographic     progression of the spine.   "
152585|NCT01286532|"     This is a six-month non-interventional prospective study of various controller therapies in     children with asthma in outpatient clinical practice.   "
152586|NCT01286519|"     The purpose of this study is to measure the level of medicines found in body fluids such as     blood, urine, spinal fluid of children.   "
152658|NCT01285583|"     The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to     riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the     preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.   "
152659|NCT01285570|"     Post-operative administration of ulimorelin is expected to reduce time to recovery of     Gastrointestinal (GI) function in patients who have undergone partial large bowel resection.   "
202619|NCT00502073|"     The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in     the treatment of dry eye syndrome.   "
152592|NCT01286441|"     Nonclinical studies have shown sandalwood oil to have anti-inflammatory, anti-fungal,     antiviral, and anti-bacterial activities. Previous clinical studies have shown East Indian     Sandalwood oil to be promising as a treatment for common warts in adults and children.      The primary objective of this study is to evaluate the efficacy and safety of 10%, 20%, and     30% East Indian Sandalwood Oil (EISO) ointment compared with the ointment placebo     administered twice daily (bid) for 12 weeks for the treatment of common warts (Verruca     vulgaris).   "
152593|NCT01286428|"     This study was designed in two phases: Phase I is designed to confirm that the surgeon is     able to perform accurate liver surface registration including standard liver features used as     landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of     comfort with the procedure.      The surface of the liver will be manually swabbed with the study tracked laparoscopic probe     with landmarks noted during data collection. After registration of the liver is obtained, the     registration points obtained during this procedure will be evaluated by the surgeon by moving     the tracked laparoscopic probe over the liver surface and evaluating the location of the     tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The     surgeon will accept or reject the registration accuracy.      The hypothesis is that the surgeon will be able to successfully acquire liver surface     registrations with a small learning curve for technique and will be able to proceed to Phase     II of the study.      Phase II contains the registration process included above but adds the additional process of     tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder     Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked     and displayed on the Pathfinder three dimensional (3D) image.      The surgeon will use ultrasound (US) guidance to locate tumor location during the     laparoscopic procedure. The images collected during this process will be recorded by     Pathfinder.   "
152594|NCT01286415|"     The purpose of this study is to compare group-administered Cognitive Processing     Therapy-Cognitive-only version (CPT-C), an evidence based treatment for posttraumatic stress     disorder (PTSD), to Present Centered Therapy (PCT) in order to determine whether the results     of CPT exceed those of receiving a therapy that focuses on current problems rather than past     trauma in a group format.   "
152595|NCT01286402|"     This study is designed to gather preliminary effectiveness and safety data on the use of     bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This     study will provide critical preliminary data in preparation for a larger, Phase III clinical     trial.   "
152596|NCT01286389|"     Obesity has been associated with cognitive impairments, lower blood flow, metabolic activity     and brain volume. Obesity in adulthood is a risk factor for Alzheimer's disease in the     elderly. The mild cognitive impairment (MCI) is a condition that may precede dementia. We     hypothesized that promotion of weight loss in obese people with MCI, through caloric     restriction could lead to improvement in cognitive performance or reduction in the rate of     decline and decreased risk of dementia. A sample of 80 patients aged ≥ 60 years, obese, with     MCI, will be randomized to two groups that will be followed for 12 months. The control group     will receive conventional medical care. The intervention group will receive nutritional     counseling individually and in groups, aiming to promote weight loss through caloric     restriction, and medical monitoring. Before and after intervention patients will be evaluated     for anthropometry, body composition, physical performance, control of comorbidities,     laboratory tests (glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor     necrosis factor alpha, CRP), Genotyping apolipoprotein E, neuropsychological battery,     questionnaires about activities of daily living, physical activity and diet.   "
152597|NCT01286376|"     Determine the effectiveness of symbiotic LACTOFOS containing FOS and probiotics against     placebo in patients with a diagnosis of constipation, comparing the average number of weekly     evacuations in 2 (two) groups for 30 days.   "
152598|NCT01286363|"     The purpose of this study is to evaluate chewing side preference, and lateral asymmetry of     occlusal contact area and bite force of individuals with different craniofacial patterns   "
152599|NCT01286350|"     The purpose of this study is to see if a behavioral intervention for adolescents with type 1     diabetes will improve adherence to T1D self-management activities and improve diabetes     outcomes. We expect the intervention to improve diabetes outcomes when compared to usual     care.   "
152600|NCT01286337|"     lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we     hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph collection     compared to the traditional surgical technique   "
152601|NCT01286324|"     The purpose of this study is to determine if an herb called chamomile can help to treat     insomnia (difficulty in going to sleep or getting enough sleep) by increasing the amount of     time that you sleep and/or improving the quality of your sleep. The study will also be     looking at the effect of chamomile on day time fatigue and functioning.   "
152602|NCT01286311|"     The primary goal of the trial is to test the feasibility and efficacy of a cardiovascular     disease quality improvement system that couples EMR-based patient identification with     individually tailored patient messages. The study will test the hypothesis that that a     tailored patient-directed approach to cardiovascular risk reduction integrated into patients'     primary care delivery site will improve control of elevated low-density lipoprotein     cholesterol and other card iac risk factors more than routine care alone for patients at     intermediate or high risk for cardiovascular disease.   "
152706|NCT01284946|"     While clinical phlebotomy is current standard practice for alleviating non-transfusion iron     overload in patients with PCT, it may not be suitable for all patients. For example, some     patients are unwilling to be adequately phlebotomized because of inconvenience, as phlebotomy     can be cumbersome, especially during the induction treatment phase requiring frequent clinic     visits (twice a month, for at least 6 months) or because of venous access difficulties. Other     patients are unable to undergo phlebotomy due to medical reasons such as anemia or     cardiopulmonary disorders. It is postulated such patients with PCT who have non-transfusion     iron overload could benefit from treatment with deferasirox (Exjade®), a once daily oral iron     chelator licensed in several countries, including the EU, for treating transfusion iron     overload in adult and pediatric patients. Although there is some data on the efficacy and     safety of deferasirox in patients with HH, who, like those with PCT, have non-transfusional     iron overload, there is a need to evaluate the safety and efficacy of deferasirox treatment     of non-transfusion iron overload in patients with PCT.   "
152603|NCT01286298|"     Gingival enlargement is one of the most common soft tissue problems associated with fixed     orthodontic treatment. The presence of orthodontic appliances impedes oral hygiene measures     and alters the oral microbial ecosystem to a more pathogenic oral biofilm. Subsequent     accumulation of plaque can contribute to development of chronic periodontal inflammation and     can progress to gingival enlargement. Gingival enlargement inhibits hygiene measures, slows     down orthodontic tooth movement and cause aesthetic and functional problems. Management of     gingival enlargement by non-surgical periodontal treatment is considered to be most important     and effective. Optimal plaque control can be maintained by meticulous brushing, flossing and     professional scaling. However, motivation of maintaining oral hygiene can be disappointing in     some patients. In cases that the enlarged gingivae became fibrous, surgical treatment can be     considered.      Traditionally, gingivectomy was performed using scalpel under local infiltration. Since the     first laser designed for dental use was introduced in 1989. Laser technology has continuously     developed over the years and there are now many different types of dental lasers using a     variety of wavelengths, e.g. Diode, Er:YAG, CO2 and Er,Cr:YSGG lasers. In orthodontics,     various intraoral soft tissues surgical procedures may be required frequently, e.g.     gingivectomy, gingivoplasty, fraenectomy, exposure of unerupted/ impacted/ partially erupted     teeth. The use of laser has becoming more popular because the advantages of laser therapy are     good haemostasis, excellent visualization of the operating field, fewer intra- and     post-operative complications, bactericidal effect, no suture required, less scars, and better     pain control with effects of reduced use of local anaesthesia and analgesic. Diode laser unit     has the merits of compact size and relatively low price. Gingivectomy by diode laser may     become an effective adjunctive treatment in orthodontic practice.      The aim of this study was to evaluate the clinical effectiveness of diode laser in the     management of gingival enlargement related to orthodontic treatment.   "
152604|NCT01286285|"     The purpose of the study is to assess the number of severe, laboratory-confirmed influenza in     children hospitalized to paediatric intensive care units. Furthermore, the proportion of     these children from all children hospitalized to paediatric intensive care units with acute     respiratory infections will be established.   "
152605|NCT01286272|"     This randomized phase II trial studies how well ofatumumab and bendamustine hydrochloride     with or without bortezomib works in treating patients with untreated follicular non-Hodgkin     lymphoma. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different     ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. It     is not yet known whether ofatumumab and bendamustine hydrochloride are more effective with     bortezomib in treating patients with follicular non-Hodgkin lymphoma.   "
152606|NCT01286259|"     The purpose of this study is to determine whether a two-week course of disulfiram will reduce     the HIV-1 latent reservoir in patients on highly active antiretroviral therapy (HAART).   "
152607|NCT01286246|"     Prematurity remains the most important single factor in perinatal morbidity and mortality.     Unfortunately, the rate of premature delivery is increasing in Canada and is especially high     in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Despite years of     research into the causes of spontaneous preterm labor, few effective treatments have been     identified. Progesterone is one candidate treatment. The purpose of this study is to     investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm     labor.      Pregnant women who have symptoms of premature labor will be invited to take part in the study     if they are between 22 to 24 weeks pregnant. If they agree to join the study, they will be     randomly allocated to either take progesterone 200mg each day via the vagina until 36 weeks,     or to take a placebo preparation. Neither the women nor their clinician will know which group     they are in.      Women and their babies will be followed until 28 days after the birth, to find out about the     length of the pregnancy, any adverse events that might occur (none have been reported in     previous trials), and to look at whether women have taken the treatment.      When the study is complete, the results for the progesterone group will be compared to the     placebo group. If progesterone is found to be useful in helping to prolong pregnancy, then     this will be a possible treatment to help mothers in the future.   "
152608|NCT01286233|"     RATIONALE: Studying samples of blood in the laboratory from patients with breast cancer may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     fatigue.      PURPOSE: This research study is studying biomarkers associated with fatigue in patients with     early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32.   "
152609|NCT01286220|"     The purpose of this study is to determine if twice weekly 10 minute dilute bleach baths     decreases disease severity in patients with moderate to severe atopic dermatitis.   "
152610|NCT01286207|"     This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949);     MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the     long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and     migraine recurrence.   "
152611|NCT01286194|"     This is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where     the principal investigator will be a pharmacist.   "
152612|NCT01286181|"     Although drug therapies and pulmonary rehabilitation have greatly improved COPD symptoms, as     many as 50% of patients with severe COPD have inadequately controlled dyspnea. Device-guided     breathing is a behavioral intervention that guides respiratory rates into a therapeutic     range; prolongation of the expiratory phase improves hyperinflation, the most significant     driver of dyspnea in this population. Device-guided breathing, has no known side-effects, and     may represent a cost effective adjunctive treatment for dyspnea in severe COPD.   "
152613|NCT01286168|"     Surgical site infection (SSI) after breast and axillary surgery occurs more often than for     other clean surgical procedures. Infection in the setting of a tissue expander can be     devastating and can lead to early implant loss and failed reconstruction. Surgical drains     have been noted as a potential source for surgical site infections. Hypothesis: Bacteria     present in surgical drains after tissue expander reconstruction may be decreased by simple     and inexpensive local antiseptic interventions.   "
152614|NCT01286155|"     To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's     esophagus (BE) in the community.      To develop a population based clinical risk factor prediction model for the diagnosis of BE     and identify novel risk factors for BE which would make population based screening more     efficient. This will be an important first step in identifying the target population for BE     screening, another crucial component of making screening feasible and efficient   "
159963|NCT01189747|"     This study will evaluate the safety and efficacy of botulinum toxin Type A compared to     placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides).   "
152615|NCT01286142|"     In June 2009, the World Health Organization (WHO) declared a global pandemic of influenza A     (H1N1). Although little is known about the pandemic influenza strain in children, during     previous pandemics and influenza seasons children less than one year of age were shown to be     at higher risk of influenza complications than older children. In light of the 2009 H1N1     pandemic situation, the U.S. Food and Drug Administration (FDA), European Medicines Agency     (EMA), and Health Canada issued emergency authorizations for oseltamivir to be used to treat     and prevent influenza in infants under 1 year of age. It is anticipated that oseltamivir use     in infants will dramatically increase due to the new authorizations for use in this     population and high prevalence of H1N1 influenza circulating in the population. Ongoing     safety surveillance is critical and this study will provide further data for evaluating the     risk/benefit ratio of prescribing oseltamivir to this population in the current milieu of     both seasonal and pandemic influenza viruses circulating in the population. The study will     also provide useful information on the dose and duration of treatment used in clinical     practice and their relationship to adverse events.   "
152616|NCT01286129|"     Background: Nasal allergen challenge (NAC) is useful to study the pathophysiology of     rhinitis, and multiple challenges may more adequately approximate natural exposure.      Objective: To determine the effect of 4 consecutive daily NAC, on clinical and inflammatory     parameters in rhinitics with or without asthma.   "
152617|NCT01286116|"     The primary objective is to assess the safety of the CardioKinetix Parachute Implant and     Delivery System in the partitioning of the left ventricle in patients with heart failure due     to ischemic heart disease.   "
152618|NCT01286103|"     The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in     the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen     in healthy adult volunteers   "
152619|NCT01286090|"     The purpose of this study is to assess the effectiveness of cisapride at improving symptoms     associated with gastroparesis (a stomach disorder) in patients with diabetes mellitus.   "
152620|NCT01286077|"     The purpose of this study is to assess the effect of bortezomib on myeloma-related bone     disease, analyzing bone mineral density (BMD) in patients with Multiple Myeloma (MMY) who     have received high dose chemotherapy and autologous stem cell transplantation for primary     treatment of MMY (single- or double-transplant). Eligible patients will be randomized (study     treatment assigned by chance like flipping a coin) to either bortezomib or observation alone.     Patients in the bortezomib arm will receive treatment of bortezomib for a total of 4 cycles.     All subjects will be followed for a total of 24 months after randomization.   "
152621|NCT01286064|"     The aim of the present prospective study was to investigate the fluorescence emission of     human blood plasma of patients with colorectal cancer.      For years, serum tumor markers have been studied for the diagnosis and follow-up of     colorectal cancer, among which carcinoembryonic antigen (CEA) has achieved promising results.     However, the sensitivity of CEA for colorectal cancer is less than 25% and elevated CEA     levels also occur in patients with benign disease, as well as in patients with other     carcinomas. Nevertheless, surveillance programs are often based on the CEA test and     combination with other markers is at present a matter of research. Alternative methods based     on optical fluoroscopy have been introduced in experimental stages for clinical diagnosis of     cancer. Few studies have been reported on the application of native fluorescence spectroscopy     of biofluids in the diagnosis of tumoral diseases. The above reported findings prompted us to     investigate the fluorescence emission of human blood plasma of patients with colorectal     cancer. For this purpose, the blood of patients was collected and the fluorescence     Preliminary measurements on plasma of patients bearing colon cancer showed that the     fluorescence spectra were mainly characterized by the presence of an emission peaking at     620-630 nm, whose excitation spectrum peaked at 405 nm. Hence, an excitation wavelength of     405 nm was selected for the study. The fluorescence emission spectra were recorded in the     range of 430-700 nm.   "
152622|NCT01286051|"     Ovulation induction (OI) using gonadotropins is one of the most widely prescribed treatments     of infertility. One common problem encountered while attempting OI using gonadotropins is     premature ovulation. The purpose of this study is to examine the effect of a single injection     of a medication, called ganirelix, to prevent premature ovulation. Patients will be divided     into two groups. In the first group, gonadotropins will be used to stimulate the ovaries. In     the second group gonadotropins will be used in addition to a single injection of ganirelix, a     gonadotropin releasing hormone (GnRH) antagonist. Pregnancy rates will be compared between     groups.   "
152623|NCT01286038|"     The purpose of this study is to evaluate the safety and efficacy of eltrombopag in people who     have myelodysplastic syndrome (MDS) with thrombocytopenia who have progressed or are     resistant to decitabine or azacitidine. (These are the only 2 drugs approved by the U.S. Food     and Drug Administration [FDA] which can improve platelet counts). The investigators (the     study doctor, study staff, and sponsor) want to find out what effects, good or bad,     eltrombopag (study drug) may have on people with low platelet counts due to MDS. The     investigators will also be testing how well eltrombopag may work at different doses in these     diseases.   "
152624|NCT01286025|"     This study is designed to examine how the type of learning case affects the thinking of     medical students in tutorial   "
152625|NCT01286012|"     The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing     the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb)     levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who     receive conventional dialysate without iron.   "
152626|NCT01285999|"     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™ Element™     Everolimus-Eluting Coronary Stent System for the treatment of subjects in China with a single     de novo atherosclerotic coronary artery lesion.   "
152627|NCT01285986|"     Randomized study to evaluate the effect of adding a vein collar at the distal anastomosis to     PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia     with respect to primary patency, secondary patency, and limb salvage   "
152628|NCT01285973|"     The aim of this prospective study is to assess the utility of treatment of leg ulcers using a     skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous     oxygen pressure in the distal region of the wound.      This is a multi-centre study on 60 patients who have a lower limb ulcer.   "
152629|NCT01285960|"     The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF     V2 System when treating symptomatic uterine fibroids.      The ExAblate System is a medical device that involves a focused ultrasound system and an MRI     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the     targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each     sonication is used to heat small spots in the fibroid much like a magnifying glass can be     used to focus light to heat a spot. The heat created kills a portion of the fibroid with the     goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are     performed until the entire fibroid is treated or the treated volume is determined to be     appropriate.      The ExAblate system is commercially approved in the United States to treat symptomatic     uterine fibroids.      The ExAblate UF V2 System is an experimental device and is being investigated in this study.     While similar to the commercial system, the ExAblate UF V2 device includes the following     major changes, among others, which are intended to improve device performance and safety:        -  Up and down movement of the ultrasound transducer, in an attempt to improve fibroid          treatment by moving the ultrasound focal point within the targeted fibroid.        -  Ultrasound energy can be turned off for a specific area in an attempt to minimize amount          of energy passing through sensitive areas of the body.   "
152630|NCT01285947|"     The purpose of this study is to compare the pain experience of patients who have not had     dermatologic procedures (previously unexposed) using energy devices (lasers,     radiofrequency, ultrasound, etc.) with patients who have previously had procedures     (previously exposed) using energy devices. Based on previous clinical encounters,     individuals with no prior experience with cosmetic procedures appear to experience more pain.     However, no study to date has thoroughly examined this observation. As a result, this study     has been designed to find a possible difference in pain perception between previously exposed     and unexposed patients undergoing cosmetic procedures using energy devices.   "
152631|NCT01285934|"     Type 1 diabetes mellitus (T1D) results from immune-mediated destruction of insulin-producing     islet cells. The loss of islet cells is traditionally treated with insulin therapy and in     some cases pancreas or islet cell transplantation. Another approach would be to preserve     islet cell mass before it is irreversibly lost. Previous trials using immune suppression     within 6 weeks of T1D onset have demonstrated diminished exogenous insulin requirements     compared to untreated controls. In our prior phase I non-randomized study, by extending     immune suppression to the point of immune ablation / immune reset with autologous HSC     support, several patients with new onset T1D have maintained an insulin-free, drug free     remissions for more than 4 years. Although these results appear highly promising, it may be     argued that our results are mitigated by the documented honeymoon effect following T1D, that     is by a normal transient insulin free interval occurring after disease onset in some     patients. The goal of this trial is to extend this phase I study of new onset T1D to clarify     whether our post transplant insulin free interval is due to treatment intervention     (transplant) or a result of a normally occurring insulin free honeymoon period. Both groups     will receive identical change of life style (i.e. diet, exercise) education.   "
152632|NCT01285921|"     Vestibular signals deeply influence hippocampal spatial representations and may contribute to     the navigational deficits of humans with vestibular dysfunction. The reciprocal influence of     hippocampal signals on the vestibular system are more putative. The investigators wish to     investigate in this pilot study the consequences on vestibular system of the removal of the     hippocampal formation to treat drug resistant temporal lobe epilepsy.   "
152633|NCT01285908|"     Background:      - Orthostatic hypotension is a fall in blood pressure when standing up. Normally, a reflex     action of the automatic nervous system makes blood vessels tighten when people stand up. The     nervous system releases the chemical norepinephrine, which tightens blood vessels and keeps     blood pressure in check. In orthostatic hypotension, the nervous system does not release     enough norepinephrine when a person stands up, which can cause fainting or falling.     Researchers are interested in determining whether norepinephrine given as a drug by vein can     help maintain blood pressure during changes in body position.      Objectives:      - To determine whether intravenous norepinephrine can maintain blood pressure in people with     orthostatic hypotension.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with orthostatic hypotension     related to Parkinson's disease or pure autonomic failure.      Design:        -  This study will require a 2-day inpatient admission to the NIH Clinical Center. The          first day will involve laboratory evaluation and the second day will involve testing          with norepinephrine. The second day requires an overnight stay.        -  Participants will be screened with a medical history and physical examination, blood          samples, and an electrocardiogram or echocardiogram.        -  Participants who are on medications may be asked to taper or discontinue one or more          medications for the purposes of this study. Participants may not take aspirin or any          drugs that slow blood clotting for 7 days before study participation.        -  Day 1: Participants will have a clear liquid breakfast, and will have a 1-hour baseline          tilt table test to monitor blood flow, skin temperature, sweating, and blood pressure.          Body temperature and breathing will also be monitored.        -  Day 2: Participants will have a clear liquid breakfast, and will have a 2-hour tilt          table test. Initial blood pressure readings will be taken, and an intravenous line will          be placed. Participants will then receive norepinephrine or saline, followed by          additional position changes of the tilt table to measure blood pressure differences          before returning to the starting position. After about 10 minutes, the tilt table          testing and infusion will be repeated with the other drug (saline or norepinephrine).        -  Participants will be discharged 24 hours after the testing is complete.   "
152634|NCT01285895|"     Main objective : This project aims to assess the educational needs of patients who received a     lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis.      Specific objectives : Evaluate the specific needs dependent on seniority transplantation : 3     to 6 months, 6 months to 2 years, more than 2 years after transplantation      Secondary objectives :        -  Assess the state of health        -  Assess the knowledge        -  Assess gestural know-how        -  Assess the cognitive know-how        -  Assess the behaviour adopted in reality by the patient        -  Assess motivation psychosocial factors of :             -  self-efficacy and inefficiency             -  representation of obstacles, disadvantages of treatment             -  sense of control over their health             -  feeling of being supported by health professionals, by his close             -  representation of his responsibility to take care of his health, to follow his               treatment, to be active about his treatment   "
152660|NCT01285557|"     The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin     compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and     esophagogastric junction cancer previously untreated with chemotherapy.   "
152661|NCT01285544|"     There will be no significant differences in the efficacy and tolerability between the test     and reference formulations of atorvastatin 20 mg in these Korean adults with primary     hypercholesterolemia.   "
152737|NCT01284543|"     The Tan EndoGlide device results in less endothelial cell trauma during insertion of the     donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared     to the Busin glide.   "
152635|NCT01285882|"     Main objective : This project aims to have a better understanding of the influence of     representations of patients with mucoviscidosis, their assistants and their medical persons     in the choice of patients to accept or not lung transplantation.      Specific objectives :        1. Identify the knowledge, representations, or feelings of patients which could constitute          bridles or factors of motivation to use for transplantation.        2. Identify the knowledge, representations, or feelings of medical persons which could          constitute bridles or factors of motivation to the encouraging proposal to patients of          lung transplant.        3. Identify the knowledge, representations, or feelings of assistants which could          constitute bridles or factors of motivation to the encouragement of lung          transplantation at its close.        4. Identify the needs of patients, assistants and medical persons to successfully reduce          these bridles to transplantation and increase the factors of motivation.        5. Compare the representations of patients, assistants and medical persons        6. Search representations associated with patients who refuse the transplantation and those          who accept the transplantation   "
152636|NCT01285869|"     The hypothesis of this study is that long-term outcome in elderly patients admitted with the     diagnosis of community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP)     would improve with a multidimensional intervention including assessment of co-morbidities,     nutritional, functional and cognitive status and immunization.   "
152637|NCT01285856|"     Justification and aims of the study: The principal aim of use of opiate substitutes such as     methadone or high-dose buprenorphine (HDB) is to reduce the need or the desire to consume the     opiate to which the patient is addicted. Adjustment of the initial dose and regular     re-evaluation of the efficacy of treatment are key elements in the success of such     management. While too high a dose can be responsible for side effects leading to abandonment     of treatment, too low a dose can induce the reappearance or even the reinforcing of parallel     consumption of other psychoactive substances, in particular cocaine, alcohol and cannabis.     The principal aim of this project is to determine the course of parallel consumption in     patients who have been receiving a maintenance dose of methadone or HDB for at least two     months, by analysis of a sample of hair, a biological matrix which is innovative for this     type of study. Hair testing establishes a retrospective profile of consumption. The secondary     aims of this project are (i) to validate the French versions of Handelsman's subjective and     objective opiate withdrawal scales and to seek a possible correlation between high scores on     these scales and the presence of parallel consumption, and (ii) to seek an association     between polyconsumption and common functional polymorphisms of metabolic enzymes of methadone     and HDB.      Expected results: Hair testing, which has the particular advantage of a long detection window     so that samples need only be taken at intervals, could improve the biological monitoring of     patients on substitutive treatment.      Validation of the French version of Handelsman's scales of objective and subjective signs of     opiate withdrawal and search for any correlation with parallel consumption will enable these     scales to be used in daily practice for clinical surveillance of patients on substitutive     treatment.      If a polymorphism of a metabolic enzyme of one or other of these molecules is detected, rapid     genotyping of a simple saliva sample will be valuable in guiding the choice of medication     when deciding on a treatment strategy   "
152638|NCT01285843|"     This is a monocentric, prospective, randomized clinical survey to verify if the     periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component     is equivalent.   "
152639|NCT01285830|"     An altered microbial exposure may be partly responsible for the increase of allergic diseases     in populations with a western lifestyle. Activation of the immune system by microbes early in     life is probably required for an accurate maturation of the immune system. Probiotics, live     bacteria which are considered to confer health when ingested, have been suggested to prevent     eczema and sensitisation infants.      The aim of this study is to assess the effect of oral supplementation with the probiotic     bacterium Lactobacillus reuteri in infancy on the development of allergic disease and     sensitisation during the first 2 years of life and to examine mechanisms possibly underlying     eventual effects on allergic manifestations.      A follow up was performed at 7 years of age.   "
152640|NCT01285817|"     To establish the anti-tumour effect of this metronomic combination regimen defined by     progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of     treatment, as well as response rate after any number of cycles of treatment (best     response).      To define the safety profile of the combination. To characterize pharmacodynamics of the drug     combination with the use of angiogenic markers (CEP, CEC, microparticles).   "
152641|NCT01285804|"     The purpose of this study is to evaluate the impact of using a cuffed endotracheal tube (ETT)     on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or     adenotonsillectomy. The study hypothesis is that inflation of the cuff on the ETT will     eliminate contamination of the oropharynx with the inspired anesthetic gases and decrease the     oxygen concentration in the oropharynx.   "
152642|NCT01285791|"     Excess visceral fat is a key factor in the development of metabolic syndrome associated with     obesity. After bariatric surgery, patients experience weight loss accompanied by a decrease     in the amount of total body fat. It is unclear how the different surgical procedures vary in     their effect on the visceral and subcutaneous fat change. Ultrasonography (US) is an     effective, efficient method in assessing this metabolically active layer of fat even when     compared with gold standard techniques such as computed tomography and magnetic resonance     imaging. Only a few studies managed to show the actual decrease in the visceral fat layer     after these kinds of surgeries. The aim is to compare by ultrasound evaluation the extent of     fat layers reduction after laparoscopic adjustable gastric banding (LAGB), laparoscopic     sleeve gastrectomy (LSG) and laparoscopic roux-en-y gastric bypass (LRYGB). The hypothesis is     that the sleeve gastrectomy and gastric bypass being not only a restrictive procedure but     also a malabsorptive procedure will have the best results in decreasing the amount of     visceral fat.   "
152643|NCT01285778|"     Chemoradiation with 5-FU and Mitomycin C is the standard treatment in anal canal SCC.     Panitumumab has shown efficacy in other tumors and anti-EGFR treatment has shown clinical     activity in a single report of a refractory anal canal SCC patient. Based on this background,     we propose to conduct a phase II study to investigate the efficacy and toxicity of     radiotherapy with the association:        -  5-FU 1000mg/m2 on days 1-4 and 29-32        -  Mitomycin C 10mg/m2 on days 1 and 29        -  Panitumumab 6 mg/m2 on day 1, then every 2 weeks for 8 weeks   "
152697|NCT01285063|"     The goal of the this study is to create an interdisciplinary program which includes     intervention in the fields of nutrition, physical activity and behavior in order to treat     obesity and overweight among kindergarten children and to examine the influence of such     program on the BMI,BMI%, physical fitness, knowledge and preferences in the said fields among     the participants.   "
152738|NCT01284530|"     Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM     XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with     epilepsy.   "
152644|NCT01285765|"     In this study, the investigators purpose is to evaluate the adaptation of treatment with     early response based on PET scan results after 2 cycles of chemotherapy, for patient aged     from 18 to 80 years, with low IPI DLBCL.      This is an open randomized study.      The primary endpoint is to evaluate the 3 years PFS with the aim to demonstrate the non     inferiority of the experimental arm in comparison to standard arm:      In standard arm, the patients will receive 6 cycles of R-CHOP 21 without taking into account     of PET scan results after 2 cycles.      In experimental arm, early good responder patients (defined as having a negative PET scan     after 2 cycles, confirmed after 4 cycles) will receive only 4 cycles of R-CHOP 21.      In both arms, if the PET scan remains positive after 4 cycles of chemotherapy, a biopsy exam     is needed to confirm the failure and an intensive chemotherapy is then recommended.      All of the patients, in both arms, will have an early evaluation with PET scan. All PET scan     will be reviewed by a group of expert according to Deauville criteria defined by Meignan et     al to adapt the decision after the 2nd cycle in experimental arm and after the 4th cycle for     all patients. The final evaluation of response will be made according to 2007 Cheson's     criteria.   "
152645|NCT01285752|"     To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.   "
152646|NCT01285739|"     The purpose of this study was to determine occurrence of ventilator associated pneumonia     (VAP) in tracheostomized patients with COPD discharged in invasive mechanical ventilation     (IMV) compared to patients with CPOPD discharged with tracheostomy but in non invasive     mechanical ventilation (NIMV).   "
152647|NCT01285726|"     The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD)     patients and its evolution over a period of four years, independent of the PD treatment     modality (APD or CAPD) and the PD solution type.   "
152648|NCT01285713|"     To determine whether the addition of dextrose to IV fluids in the treatment of     gastroenteritis leads to a decrease in serum ketones. Secondarily, the clinical benefits of     dextrose containing fluids in the treatment of gastroenteritis will be assessed.   "
152649|NCT01285700|"     This is a single-center, open-label, multiple-dose study of the efficacy and long-term safety     of Lamazym for the treatment of patients with alpha-mannosidosis.   "
152650|NCT01285687|"     A randomized, controlled, single-blinded study comparing conventional postoperative analgesia     with paracetamol-on-demand with the same regime plus acupuncture.      The hypothesis is that postoperative treatment of children undergoing tonsillectomy with     acupuncture will reduce pain with minimal unwanted effects.   "
152651|NCT01285674|"     In this study we will aim to determine if cisplatin ototoxicity can be prevented by     intratympanic administration of corticosteroids.   "
152652|NCT01285661|"     Prospective cohort study aimed at optimizing the duration of anticoagulant treatment in     patients at their first episode of proximal deep venous thrombosis (DVT) of the lower     extremities, whose pathogenesis is either unknown (idiopathic DVT) or associated with minimal     risk factors for thrombosis, with the help of an algorithm which incorporates both     ultrasonography and D-dimer information. All patients will be followed-up until 1) the     achievement of a major end-point; 2) the date of lost to to followup; 3) the date of death;     4) the date of study stop. The purpose of this study is to demonstrate the safety of     withholding anticoagulation from a subgroup of patients with proximal DVT whose veins have     recanalized and present with a repeatedly negative D-dimer (at baseline, after 1 and 3     months). The approach will be deemed to be safe if the annual rate of recurrent VTE in     patients who will have their anticoagulation discontinued is lower than 5%.   "
152653|NCT01285648|"     The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and     evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two     groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive     Airway Pressure (CPAP) patients.   "
152654|NCT01285635|"     This study will examine the effects of an investigational drug called AT-101 in combination     with an FDA approved cancer drug called Docetaxel. It is hoped that AT-101 will help the     Docetaxel to have a better effect in slowing or stopping cancer cell growth. This study will     help the researchers learn what effects, if any, the combination of AT-101 and Docetaxel has     on your cancer. For instance, will the combination cause your tumor(s) to shrink or stop     growing? The researchers will also learn about the safety of the combination of AT-101 and     Docetaxel. For instance, are there any side effects? If so, what kind of side effects does     the combination cause? How severe are the side effects, and how often do they occur?   "
152655|NCT01285622|"     The investigators propose a prospective observational trial. The investigators plan to enroll     40 female subjects scheduled for elective robotic gynecological surgery under general     anesthesia. Hemodynamic data will be recorded at the following intervals: after induction of     anesthesia (Baseline), after initiation of pneumoperitoneum, after positioning the patient in     Trendelenburg position, and every 15 minutes thereafter. At the end of surgery measurements     will be recorded after reversal of Trendelenburg position and after deflation of the     peritoneum.      Forearm - fingertip temperature gradients will be measured by Mon-a-thermometer (Mallinckrodt     Medical, Inc. St. Louis, MO) and disposable Mon-a-therm thermocouples. Vasoconstriction will     be identified when forearm - fingertip temperature gradient is ≥ 00C and PI <1.      Intra-abdominal pressures will be recorded during each measurement of hemodynamic parameters.     Trendelenburg position will be measured with an angle ruler.      The aim of our study is to test the hypothesis that stroke volume will drop significantly     after initiation of pneumoperitoneum and that it will increase after placement in     Trendelenburg position in patients undergoing robotic gynecological procedures. Secondly, the     investigators will test the hypothesis that PVI changes correlate with changes in stroke     volume and pulse pressure variation (PPV) and can predict an increase in stroke volume after     a fluid bolus. The third hypothesis is that delta PVI is independent of the vaso-status of     precapillaries at the measured site.   "
152656|NCT01285609|"     The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin     will extend the lives of patients with squamous only non small cell lung cancer more than     placebo plus Paclitaxel and Carboplatin.   "
152657|NCT01285596|"     Young and elderly, male and female subjects are each given 2 different doses of mirabegron     for 7 days each. Levels of mirabegron in the blood are assessed.   "
152747|NCT01284413|"     The objective of this study is to evaluate the safety of GCS therapy for phase I and efficacy     of GCS therapy for phase II.   "
152662|NCT01285531|"     Objective: To evaluate pediatric emergency department provider lumbar puncture success with     and without the Compass Lumbar Puncture Enhanced, a new pressure transducer, in order to     determine: the proportion of lumbar punctures where a) any cerebrospinal fluid is obtained on     the first attempt, b) any cerebrospinal fluid is obtained on any attempt, and c) sufficient     cerebrospinal fluid is obtained for standard tests (culture, chemistries, cell count); the     time to provider success in obtaining a) a drop of fluid from the needle, and b) opening     pressure measurement; the proportion of successful lumbar punctures that contain blood; and     provider satisfaction.      Background: Lumbar punctures are necessary to diagnose meningitis, neurological diseases and     some cancers. They are common pediatric emergency department procedures that frequently     require repeated attempts or are only partially successful, with sufficient blood to limit     interpretation. Measuring cerebrospinal fluid pressure during lumbar punctures is recommended     but rarely done, due to limitations of current technology. Liquid column manometry is     cumbersome, time-consuming and frequently impractical. Existing pressure transduction probes     that connect via tubing to external monitors are not designed or recommended for lumbar     punctures. The pressure is displayed on a monitor that is difficult to view during the LP     procedure and they equilibrate too slowly to keep pace of pressure changes during LPs. The     Compass Lumbar Puncture Enhanced is a new, inexpensive, disposable, medical device,     specifically designed for use during LPs, that has the potential to increase lumbar punctures     success and decrease blood contamination. It attaches to the spinal needle and displays both     a numeric pressure value and a pressure waveform, allowing physicians to more readily     identify the cerebrospinal fluid space and measure cerebrospinal fluid pressure. The device     is small, easy to use, and readily incorporated into standard practice.      The Compass Lumbar Puncture Enhanced uniquely provides immediate feedback about pressure that     may allow physicians to more quickly and confidently identify the CSF space, and instantly     determine cerebrospinal fluid pressure when the space is reached. The investigators believe     the Compass Lumbar Puncture Enhanced will increase lumbar punctures success and decrease the     proportion containing blood. It has the potential to become the standard of care and be used     in every lumbar puncture procedure. This study is expected to demonstrate the clinical     utility of the Compass Lumbar Puncture Enhanced to the medical community. Increased awareness     of the Compass Lumbar Puncture Enhanced and a positive demonstration of the viability of the     technology will help attract either the investment capital or the strategic partnership     necessary to fully develop the market.   "
152663|NCT01285518|"     This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability     and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.   "
152664|NCT01285505|"     This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual     formulation is the same as that from an existing sublingual formulation.   "
152665|NCT01285492|"     This is a 52-week treatment, multi-center, randomized, open label, parallel group study to     assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237     ([glycopyrronium bromide]) using tiotropium as an active control in Japanese patients with     moderate to severe chronic obstructive pulmonary disease (COPD).   "
152666|NCT01285479|"     The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis     (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects     in the offspring of women exposed to Gilenya before (up to 8 weeks before last menstrual     period) and during pregnancy in routine clinical practice. The overall aim is to collect and     evaluate data on maternal, fetal, and infant outcomes and compare it with reference     populations.   "
152667|NCT01285466|"     The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and     BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.   "
152668|NCT01285453|"     This study will assess the tolerability of combination therapy with ASA404 and docetaxel in     Japanese patients with advanced or recurrent solid tumors.   "
152669|NCT01285440|"     The purpose of this study is to show that improvements in the molecular breast imaging (MBI)     technology will allow reduction of the administered dose of Tc-99m sestamibi while     maintaining a sensitivity of 90% for tumor detection.   "
152670|NCT01285427|"     The purpose of this study is to compare the Invitrogen SeCore(R) sequencing system and     uTYPE(R) interpretation software to the predicate device Invitrogen SSP UniTray(R) with     UniMatch(R) interpretation software and show 95% concordance with 90% confidence.   "
152671|NCT01285414|"     This, international, multi-center, Phase 2 study of verubulin will be conducted in patients     with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts.     Part A is an open-label dose finding study that will determine the safety and tolerability of     verubulin in combination with standard treatment. Part B is a randomized open-label study     that will investigate progression-free survival and overall survival of patients receiving     verubulin, at the dose determined in Part A, in combination with standard treatment versus     standard treatment alone.   "
152672|NCT01285401|"     The drug being tested is called VigantOL® oil - a very effective form of Vitamin D hormone     supplement (cholecalciferol). Low levels of Vitamin D have been described to be associated     with a higher risk of developing Multiple Sclerosis (MS), and it is known that up to 90% of     patients with Multiple Sclerosis have Vitamin D deficiency.      Rebif® is known to be an effective treatment for slowing down the progression of MS. The     purpose of this research trial is to evaluate if VigantOL® oil on top of Rebif® has any     benefit on the progression of MS compared to Rebif® and placebo.      Disease activity will be assessed by clinical examination and Magnetic Resonance Imaging     (MRI). The planned study treatment duration for each study participant is 48 weeks, and the     study consists of a total of 8 visits. Study participants who are already passed Week 48 at     the time of approval of Protocol Amendment 5 will have a study duration of 96 weeks and a     total of 12 visits.      During the study, the participant will undergo physical examination, neurological     assessments, safety assessments, blood tests and urinalysis (including pregnancy tests).   "
152673|NCT01285388|"     The purpose of this study is to investigate the safety and tolerability of MB12066 after a     single oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a     single oral dose.   "
152674|NCT01285375|"     The safety and preliminary efficacy of the addition of an aqueous curcumin-cyclodextrin     complex (CDC) solution to graft perfusion solution is studied. CDC has proved safe and highly     effective in preventing primary graft non-function, delayed graft function and chronic     dysfunction in pre-clinical kidney transplantation animal models. The hypothesis is that     addition of CDC to the graft perfusion solution will decrease the incidence of delayed graft     function in human kidney transplantation subjects.   "
152698|NCT01285050|"     The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type     specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/     HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications     (antiretroviral therapy).   "
152739|NCT01284517|"     Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression.     This clinical study is designed to test the hypothesis that Lurasidone in combination with     either Lithium or Divalproex is effective among patients with bipolar I depression.   "
152707|NCT01284933|"     The purpose of this study is to determine the frequency, characteristics, and consequences of     vulnerable carotid artery plaques ipsilateral to an acute ischemic stroke or TIA in the     territory of the internal carotid artery.   "
152675|NCT01285362|"     Over the past 30 years, the prevalence of childhood obesity in the United States has tripled     from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes,     cardiovascular disease and nonalcoholic fatty liver disease (NAFLD). The liver pathology     encompasses a range from isolated fatty liver to advanced fibrosis, cirrhosis and end-stage     liver disease. Weight loss, particularly if gradual, may lead to improvement in liver     histology. Unfortunately, few patients in the pediatric population are willing to follow     these recommendations and achieve weight loss. Medical treatment directed specifically at the     liver disease has only recently been investigated and approved in patients with NAFLD. The     beneficial effects of fish oil are attributed to its high concentrations of n - 3 fatty     acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are major regulators     of pathways that participate in decreased production and break down of triglycerides and     fatty acids in the liver. We hypothesize that children with obesity related NAFLD will     normalize elevated liver enzymes, plasma lipid levels, and attenuate insulin resistance with     supplements of n-3 fatty acids. If this hypothesis is proven true, then fish oil could be     used to treat NAFLD and to prevent the deterioration of fatty liver into end-stage liver     disease.   "
152676|NCT01285349|"     This randomized controlled trial is designed to address gaps in couple-based HIV prevention     research by focusing exclusively on HIV negative concordant couples where one or both     partners are drug-involved. Building on prior couple-based HIV research that resulted in an     evidence-based HIV prevention model for couples (Connect), intervention components were     modified to address dyadic drug risk reduction and drug-related unsafe sex and a couple-based     HIV risk reduction intervention (Connect II) was designed specifically for drug-involved, HIV     negative concordant heterosexual couples at risk for HIV/STIs. For this RCT, couples are     recruited primarily through street outreach in drug using locations and randomized into one     of three arms: (1) couple-based HIV Risk Reduction condition; (2) individual-based HIV Risk     Reduction, which delivered the same content as the couple-based condition but was provided to     either the male or female drug-using partner alone; or (3) couple-based Wellness Promotion,     which served as an attentional control arm. This RCT tests two major hypotheses: (1) whether     the HIV risk reduction intervention provided to the couple or an individual partner would be     more efficacious in decreasing number of unprotected acts of intercourse and having a lower     cumulative incidence of biologically confirmed STIs over the 12-month follow-up period     compared to the Wellness promotion control arm and (2) whether the couple-based HIV risk     reduction intervention would be more likely to decrease the number of unprotected acts and     have a lower cumulative STI incidence compared to the Individual HIV Risk reduction Arm.   "
152677|NCT01285336|"     This study is valuable for the understanding the role of DNA repair system plays in the     progression of rheumatoid arthritis and for the development of new therapeutic modality in     the future.   "
152678|NCT01285323|"     The primary objective of this study is to determine whether reslizumab is more effective than     placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with     eosinophilic asthma.   "
152679|NCT01285310|"     The purpose of this study is to determine whether Apremilast is safe and effective in the     treatment of patients with rheumatoid arthritis, specifically in improving signs and symptoms     of rheumatoid arthritis (tender and swollen joints, pain, physical function and structure) in     treated patients who have had an inadequate response to Methotrexate.   "
152680|NCT01285297|"     The purpose of this study is to determine the safety of injecting autologous bone marrow     concentrate with laser transmyocardial revascularization (TMR) for treatment of angina which     cannot be treated by direct coronary intervention.   "
152681|NCT01285284|"     This study will evaluate the efficacy of music (a very well selected list of songs)on     improving the tolerance to the colonoscopy. The patients will be randomly assigned to receive     music or not. The authors hypothesis is that music is able to improve the tolerance to     colonoscopy evaluated as a reduction on the level of anxiety, on the intensity of pain     experimented during the procedure and a reduction of the administered dose of midazolam     during the colonoscopy.   "
152682|NCT01285271|"     The aim of this study is to determine whether xenon - as compared to sevoflurane - can be     applied safely in patients for general anesthesia before and after CABG implantation.   "
152683|NCT01285258|"     The purpose of this study is to determine the effects of peripartum hysterectomy for maternal     hemorrhage.   "
152684|NCT01285245|"     The purpose of this study is to test whether anakinra is able to reduce insulin resistance.      This will be tested in overweighted type I diabetes mellitus patients, which have no residual     beta-cell function. By using this patient group, all positive effects on glycemic control     should be the consequence of improved insulin sensitivity.   "
152685|NCT01285232|"     Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic     approaches that prevent of delay loss of β-cell function are needed in the treatment of type     2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may be involved in the     progressive β-cell dysfunction in type 2 diabetes mellitus.      Objective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra)     improves beta-cell function in subjects with β-cell dysfunction.   "
152686|NCT01285219|"     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor     to limit the dosage and delay the schedule of chemotherapy. Preventive filgrastim     administration has long been established as the standard of care. A pegylated filgrastim was     independently developed by GeneLeuk Biopharmaceutical Co., Ltd, Shandong, China. It composed     of filgrastim and a 20 kd polyethylene glycol molecule covalently bound at the N-terminal     residue. Preclinical studies phase 1 and phase 2 trials have shown that pegylated filgrastim     has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare     with ﬁlgrastim. These characters were similar to those of Neulasta.      The investigators designed a multicenter, randomized, cross-over phase Ⅲ trial to compare the     efficacy and safety of a single injection of pegylated filgrastim and daily injections of     ﬁlgrastim in chemotherapy naive patients receiving commonly used regimens. The hypothesis is     that pegylated filgrastim is similarly effective and safe with regular filgrastim.   "
153163|NCT01278966|"     The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children     and adolescents with drug-resistant epilepsy regarding seizure control, and to create a     protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway.   "
152687|NCT01285206|"     Patients whose temperature drops below 36.0 degrees Centigrade during or after surgery suffer     more complications, such as wound infections and increased blood loss, resulting in more     blood transfusions and longer hospital stays than those who don't.      There is evidence that even a drop below 36.5 degrees Centigrade is sufficient to cause     significant adverse effects. Although there is much evidence regarding the effectiveness of     warming for long operations, there is nothing looking at short procedures such as those     undertaken in the daysurgery setting.      A new carbon polymer blanket (HotDog Augustine Biomedical and Design) has been shown, in     volunteer studies, to be as effective as forced air warming blankets (which are used for long     operations) in preventing hypothermia. In contrast to forced air, the carbon polymer is     reusable and has lower running−costs so is likely to be cheaper in the long term. This is     particularly relevant in the day surgery setting where high numbers of patients are operated     on. Additionally, and unlike the forced air warmers, the blanket can run on a battery so it     can be applied from the moment the patient goes to sleep to the moment they wake up so it     could actually prove more effective at preventing hypothermia in the clinical setting. This     study aims to determine whether the carbon polymer blankets can reduce the incidence of     hypothermia in the day surgery (ie. short operating time) setting.   "
152688|NCT01285193|"     The purpose of this study is to determine if blood pressure can be reduced in hypertensive     subjects by regularising and slowing their breathing. This may be a safe and affordable     complementary treatment for hypertension.   "
152689|NCT01285180|"     Daxas (roflumilast) is the first oral anti-inflammatory phosphodiesterase inhibitor (PDE-4)     for patients with severe chronic obstructive pulmonary disease (COPD) experiencing chronic     cough and sputum and with a history of exacerbations as add-on to bronchodilator treatment.     With its mode of action Daxas can reduce exacerbations rates and improve lung function     parameters which may result in a better health-related quality of life and an improved     long-term management of COPD.      The aim of this non-interventional study is to evaluate data on quality of life in COPD     patients in Germany in a real life medical setting. Evaluation is based on two COPD specific     questionnaires to assess the patient`s health status over six months. During the study,     socio-demographic data and cost-of-illness data will be recorded. Daxas (tablet) will be     administered once daily. The study will provide further data on the safety and tolerability     of Daxas.   "
152690|NCT01285167|"     Chronic obstructive pulmonary disease (COPD) is a progressive and largely irreversible lung     disease characterized by chronic bronchitis and/or emphysema, resulting in breathlessness,     cough and sputum. As COPD progresses, patients experience increasing deterioration of their     health-related quality of life, with greater impairment in their ability to work and     declining participation in social and physical activities.      The aim of this non-interventional study is to evaluate data on quality of life in COPD     patients in Germany in a real life medical setting under therapy with the     phosphodiesterase-inhibitor (PDE-4) roflumilast (Daxas). Evaluation is based on two COPD     specific questionnaires to assess the patient`s health status over six months. During the     study, lung function measurements such as spirometry will be conducted according to common     medical standard. Daxas (tablet) will be administered once daily. The study will provide     further data on the safety and tolerability of Daxas.   "
152691|NCT01285154|"     Steel triple innominate osteotomy was designed for dysplastic hip in adolescents and young     adults with three incisions to increase the coverage; however the amount of correction     remained questionable due to ligamentous attachments that hinder the rotation. The     investigators modified the technique with two anterior incisions and ramus cuts close to     inferior acetabulum. The purpose of this study is to compare these two techniques in femoral     head coverage   "
152692|NCT01285141|"     A vaccine to prevent infection with the Human Immunodeficiency Virus (HIV) is urgently     needed. Worldwide, most HIV infections occur through sex between a man and woman. The vaccine     in this study consists of a protein from HIV that has been synthetically produced and linked     to a protein that boosts immune responses. It has not been tested in humans before, but it is     expected (from animal studies) that direct application into the female genital tract (via the     vagina) as liquid drops, will provoke immune protection at the site of HIV infection. This is     less applicable to men, therefore only healthy, HIV negative women will be recruited. The     investigators will recruit at one site, which is a university vaccine research centre with     experience of running similar trials. The study will last 24 weeks during which subjects will     have blood samples taken on six visits, and three immunisations over 12 weeks in which 1     millilitres of vaccine is placed into the vaginal by inserting a small plastic syringe. The     purpose of this initial small study is to monitor safety of the vaccine and to determine     whether it is appropriate to continue into future, larger studies in which the immune     response to the vaccine is measured.   "
152693|NCT01285115|"     In this randomized, double blinded, Parallel-controlled study, the investigators planned to     give Gamisoyosan extract, Gamisoyosan extract powder or controlled medication on Anxiety of     generalized anxiety disorder according to dosage form.   "
152694|NCT01285102|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different     ways to stop the growth of tumor cells, either by killing the cells or stopping them from     dividing. Chemoembolization kills tumor cells by blocking blood flow to the tumor and keeping     chemotherapy drugs near the tumor.      PURPOSE: This phase II trial is studying how well chemoembolization using irinotecan works in     treating patients with liver metastases from metastatic colon or rectal cancer.   "
152695|NCT01285089|"     This study is conducted in Europe. The aim of this prospective, observational study are to     describe the different clinical practice and detailed haemostatic management of activated     recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France.     The secondary aim is to assess the primary haemostasis disorder associated with the     coagulation disorders, if available.   "
152696|NCT01285076|"     This is a multi-center, observational, retrospective and cross-sectional study to be     conducted in a cohort of consecutively selected participants with Type 2 diabetes mellitus     (DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF)     combination therapy by their cardiologist, nephrologist, neurologist, or family practice     doctor for at least 6 months prior to Study Enrollment.   "
154843|NCT01257633|"     The main objective of this study is to determine the rate of healthy surgical margins after     tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early     stage (T1-T2) laryngeal cancer.   "
152699|NCT01285037|"     Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to     participants with advanced cancer and to determine any side effects that may be associated     with LY2801653 in this participant population. Efficacy measures will be used to assess the     activity of LY2801653.      Part B- The dose determined in Part A will be used along with efficacy measures to assess the     activity of LY2801653 in participants with adenocarcinoma of the colon or rectum, head and     neck squamous cell carcinoma (HNSCC), uveal melanoma with liver metastasis, and     cholangiocarcinoma.      Part C - the objective of Part C is to determine a recommended Phase 2 dose of LY2801653 that     may be safely given to participants with HNSCC when taken with standard doses of cetuximab     Part D - the objective of Part D is to determine a recommended Phase 2 dose of LY2801653 that     may be safely given to participants with cholangiocarcinoma when taken with a standard dose     of cisplatin.      Part E - the objective of Part E is to determine a recommended Phase 2 dose of LY2801653 that     may be safely given to participants with cholangiocarcinoma when taken with gemcitabine plus     cisplatin.      Part F - the objective of Part F is to determine a recommended Phase 2 dose of LY2801653 that     may be safely given to participants with gastric cancer when taken with ramucirumab.   "
152700|NCT01285024|"     This is a prospective, randomized, controlled, single-center study to assess the     effectiveness of Vitagel, a surgical hemostat, in primary unilateral total hip arthroplasty     (THA). This will be an inter-patient controlled study involving one-hundred-ten subjects.     Vitagel will be used in a randomly selected cohort of fifty-five patients undergoing primary     unilateral THA procedures; a control group of fifty-five patients will not receive Vitagel or     any other hemostatic agent except those that are standard during a primary THA. The study     will evaluate the effectiveness of Vitagel in reducing intra- and post-operative bleeding.   "
152701|NCT01285011|"     Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the     most frequently affected, but the other small toes may also be involved. When nonoperative     treatment fails, surgery often is recommended. One surgical option is the arthrodesis of the     Proximal Interphalangeal (PIP) joint. This arthrodesis is technically demanding, its needs:        -  Internal fixation;        -  Interphalangeal Compression;        -  Anatomic PIP joint plantar flexion angle. The implant Ipp-On has been developed for this          specific arthrodesis. The objective of this study is to evaluate the efficacy and safety          of the Proximal Interphalangeal Implant: Ipp-On at short term follow up.      The safety of the Ipp-On will be described in terms of rate of device related complications.      The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months.   "
152702|NCT01284998|"     In case of deformities of the forefoot (Hallux-valgus, Hallux-varus), the basal osteotomy may     be more indicated than the distal osteotomy as it allows to achieve a greater degree of     correction.      However, weight bearing forces on the head of the first metatarsal acting at a distance from     the osteotomy site subject the construct to an important dorsiflexion stress. Fixation     strength being the important consideration led to design the B-BOP® Lock plate, specifically     dedicated to basal osteotomy of the first metatarsal, with the following characteristics:        -  plantar positioning to obtain the best stability and resistance while reducing the          implant bulkiness;        -  anatomical shape adapted to the plantar curve of the first metatarsal. Taking advantages          of the most appropriated anatomical site to implant the B-BOP® Lock plate directly on          tension, it offers an innovative and unique basal osteotomy fixation solution.      The B-BOP® Lock osteosynthesis plate benefits now of the Surfix locking screws technology.      The purpose of this study is to collect and publish data from several centers, several users.   "
152703|NCT01284985|"     The great toe is vital for normal, pain free ambulation. Decreased function associated with     osteoarthritis of the first matatarsal phalangeal joint (MTP I) often called Hallux Rigidis     or Hallux Limitus leading to a painful great toe. Patients experience pain during ambulation     especially during the push-off phase of gait. When surgery is indicated four techniques are     used for hallux rigidis; cheilectomie, resection arthroplasty, arthrodesis and implant     surgery (1). Endoprostetic implants are relatively new. Silicone Implants like the     arthroplasty developed by Swanson (2) resulted in foreign body reactions and periarticular     bone loss. Subsequent implants, in particular the metallic hemi arthroplasty with or without     polyethylene articulations, have been more successful (3). Still, implants are prone to wear     of the material and show higher rates of loosening and infection compared to other techniques     (4;5). In the last decades several new implants are described using two non cemented pressfit     components, of titanium alloy or ceramic (6-9). Between 2001 and 2004 the investigators     developed a new concept with instrumentation for exact alignment to prevent for wear with     loosening of the implant on the long term. The implant has bone-conserving characteristics to     enable arthrodesis as a salvage procedure. It is a completely modular two-component press fit     titanium alloy implant with polyethylene insert that can be used as either for hemi-, total-     or revision arthroplasty.      The purpose of this study is to have an overview of clinical status of the patient implanted     with the METIS® prosthesis at short term (2 years of follow-up). The objective of this study     is to evaluate the safety and efficacy of the Metatarso-Phalangeal prosthesis METIS® at short     term follow up.   "
152704|NCT01284972|"     The Hintegra® Total Ankle Prosthesis is a non constrained, three-component prosthesis that     consists of a flat tibial component, an anatomically-shaped talar component, and a     high-density polyethylene inlay. The Hintegra ankle was specifically developed as an attempt     to address the needs of minimal bone resection, extended bone support, proper ligament     balancing, and minimal contact stressed within and around the prosthesis.      The objective of this study is to evaluate the safety and efficacy of the HINTEGRA® Total     Ankle prosthesis at short and mid term follow up.   "
152705|NCT01284959|"     The main objective of this study was to assess subjective experiences related to secondary     negative symptoms and cognitive performance in healthy volunteers in response to multiple     doses of paliperidone ER and risperidone in a double-blind, placebo-controlled trial. Adverse     events caused by these drugs were also evaluated.   "
152740|NCT01284504|"     The proposed study aims to investigate how the administration of a drug known to reduce     inflammation in humans, Celecoxib, will effect the peri-operative inflammatory response of a     patient undergoing primary tumor resection surgery for colon cancer. The proposed project is     an exploratory study, and will use data from blood samples and tumor samples to attempt to     elucidate the immune and inflammatory response in colon cancer patients undergoing primary     resection of their tumors.   "
152710|NCT01284894|"     Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy,     patients with dysphagia are referred for esophageal motility testing. Esophageal manometry is     the gold standard to evaluate esophageal motility in absence of esophageal obstruction. Two     different techniques are available: the conventional manometry and the high resolution     manometry. The second one may improve the diagnostic yield and the tolerance of examination     in patients with dysphagia.   "
152711|NCT01284881|"     Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a     treatment option for sleep-disordered breathing (SDB).      The purpose of this study is to compare active measurement of MRA compliance with patient's     self-report.   "
152712|NCT01284868|"     To explore what is driving heart-rate increases after dosing with mirabegron. Subjects will     be given a beta-blocker at the same time as mirabegron.   "
152713|NCT01284855|"     This study aims at comparing two doses of antivenom in the treatment of snake bite     envenoming. It will take place in 3 centers in rural Nepal and will involve 250 snake bite     victims presenting with one or more sign of neurotoxic envenoming. The objective of the study     is to generate enough scientific evidence to improve Nepal's current national guidelines for     the management of snake bites.   "
152714|NCT01284842|"     The study aimed to evaluate the effects of 24-Hour-Call-associated acute partial sleep     deprivation on surgical residents` technical and cognitive performance in a virtual reality     (VR) setting. Physiological parameters were used to quantify fatigue in respect to hours of     sleep and subjective degrees of sleepiness. Technical performance and cognitive skills were     assessed through low- and high fidelity tasks usig the VR- simulator LapSim. Objective     alertness was measured by the standardized d2-Paper-Pencil-Test. Cited assessments were     performed on three consecutive mornings- pre- and post-call as after 24 hours resting.   "
152715|NCT01284829|"     This is a prospective study which aims to validate a new diagnostic approach in the tissue     characterization of adrenal tumors indeterminate on conventional imaging. For this purpose,     it is not necessary to have a control group since the diagnostic accuracy in a well defined     subset of patients.      Visit 0 : Enrollment, eligibility. Visit 1 : FDG-PET. Visit 2 : Postoperative visit. Visit 3     : 6 months post-PET. Visit 4 : 12 months post-PET.   "
152716|NCT01284816|"     Growing evidence suggests that bariatric surgery is a relevant treatment for severely obese     patients, especially those with metabolic complications, as it significantly reduces weight,     hypertension and ameliorates glycemic control. Its action on adipose tissue distribution and     in particular on epicardial adipose tissue EAT remains unknown. Whether metabolic improvement     is associated with EAT reduction is also unknown.      The researchers thus investigated the effect of bariatric surgery on EAT in severely obese     patients. The primary endpoint of this study was the change in EAT amount 6 months after     bariatric surgery.   "
152717|NCT01284803|"     Qualitative study based on interviews and questionnaires with patients participating to an     educational intervention to improve the management of depression in primary care.      Objective is to assess feasibility and acceptability of an educational intervention to     improve the management of depression in primary care To elaborate an educational program for     the management of depression in primary care.   "
152718|NCT01284790|"     Cochlear implants (CIs) have restored some sense of hearing to more than 120 000 people     worldwide. While most patients show good scores of speech recognition in quiet, a large     majority of them also struggle in more challenging listening situations, such as speech in     noise or music. This project aims to understand the basic mechanisms of electrical     stimulation of the auditory nerve, in order to identify the important cues that the     electrical signal should convey and to possible improve sound perception by CI users.   "
152728|NCT01284660|"     The purpose of this study is to assess effects of Docosahexaenoic Acid (DHA) as an add-on     novel supplement on quality of life, cognitive function, craving and psychosocial factors in     heavy cigarette smokers. In humans, no previous randomized, double blind controlled study has     been conducted to evaluate these effects. The aim of the study is to 1. Test Docosahexaenoic     Acid (DHA) beneficial effects on objective clinical indicators of cognitive function (choice     reaction time, decision making, impulsivity, facial recognition) in smokers 2. Improvement of     quality of life, cigarette craving, psychosocial factors and self-perceptions in smokers     treated with DHA supplement   "
152729|NCT01284647|"     The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic     erosive gastritis and its therapeutic mechanism   "
152730|NCT01284634|"     The purpose of this study is to assess the effect of cannabidiol (CBD) on liver triglyceride     (liver fat) in subjects with fatty liver disease.   "
152731|NCT01284621|"     Primary objective:To investigate if BI 10773 affects the pharmacokinetics of ramipril and if     ramipril affects the pharmacokinetics of BI 10773.   "
152719|NCT01284777|"     Accurate characterization of malignant cells obtained via thoracocentesis is of paramount     importance in the management of cancer patients. The identification of novel biomarkers may     in that regard considerably improve the diagnostic approach of these pleural effusions, guide     therapeutic decisions, particularly with respect to targeted therapies, and offer helpful     prognostic information. Nuclear anomalies represent the cornerstone of the cytologic and/or     histopathologic diagnosis of malignant cells. The nuclear matrix is a fundamental constituent     of the nuclear architecture via its interaction with the nuclear membrane, but is also     directly involved with DNA and RNA processing. Prior studies have suggested that in some     cancers, the lamins, a major constituent of the nuclear matrix, have different patterns of     expression or nuclear localization that could potentially have prognostic implications. Our     project aims at studying the constituents of the nuclear matrix of malignant cells isolated     for pleural fluid in patients with metastatic disease, both of bronchogenic or     non-bronchogenic origin, which, to our knowledge, has not yet been done. Both proteomic     (localization by immunofluorescence and expression by Western-Blot) and genomic (microarray,     CGH type) analyses will be undertaken to identify microrearrangements in the genes of     interest. The primary aim is to identify specific biomarkers to more accurately characterize     malignant cells in metastatic pleural disease.   "
152720|NCT01284764|"     A low volume of water intake and mosapride will effectively reduce food residue in remnant     stomach for patients who had undergone subtotal gastrectomy due to gastric cancer.   "
169818|NCT00061100|"     The purpose of this study is to evaluate HIV counseling intervention for Methadone-Maintained     Patients.   "
152721|NCT01284751|"     The purpose of this study is to measure depressive symptoms in breast cancer patients before     surgery with Major Depression Inventory (MDI). The investigators hypothesize that this     patient group will not produce scores correlating to having a mild, moderate or severe     depression even though they have just recently experienced a major life crisis by receiving a     malignant diagnosis.   "
152722|NCT01284738|"     The results will allow us to evaluate the role of MP in the thrombo-embolic risk observed in     thalassemic patients and to underline a possible difference between TM and TI. The in vitro     and in vivo study of MP in erythrocytes concentrates is a new approach to explore the     consequence of transfusion in polytransfused patients. Finally, the identification of a     possible relationship between the oxidative stress and the production of MP may lead to the     development of specific therapeutical approaches   "
152723|NCT01284725|"     The investigators wish to evaluate the discontinuation of maintenance immunosuppressive     treatment after 2 years in patients with stable remission after a proliferative lupus     nephritis. The patients will be continuing their treatment with hydroxychloroquine, possibly     associated with low dose corticosteroids.   "
152724|NCT01284712|"     Natural Killer cells (NK) are pivotal cells of innate immunity, that sense defective     expression of HLA class I molecules and are complementary to specific cytotoxic T     lymphocytes. A defect in NK cell cytotoxicity has been described in some hematopoietic     malignancies such as acute myeloid leukemia, multiple myeloma, myelodysplastic syndroms. This     defect is at least partially linked to a decreased or absent expression of some activating NK     cell molecules, more particularly the so-called Natural Cytotoxicity Receptors (NCRs) NKp30,     NKp44 and NKp46. Some old publications have demonstrated defective NK cytotoxicity in     myeloproliferative syndroms (chronic myeloid leukemia, primary thrombocytosis, polycythemia     vera). The investigators more particularly focused their attention on polycythemia vera     (Vaquez's disease), a myeloproliferative disease characterized by the recently describet     mutation V617F of the JAK2 tyrosine kinase. The investigators will precise the mechanisms     leading to this cytotoxicity defect, the investigators also will evaluate the implication of     V617F mutation on NK physiology, and will study the interactions between NK cells and     hematopoietic progenitors.   "
152725|NCT01284699|"     The goal of our trial is to evaluate the tolerance and efficacy of the STN radiosurgery in     Parkinsonian patients presenting with the inclusion criteria for the STN stimulation but     presenting also with clear contraindications to the implantation of the deep brain     electrodes.   "
152726|NCT01284686|"     Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is     abnormally synchronised and rhythmic. The oscillatory activity prevails at 8-30 Hz in     untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels     inversely correlates with motor impairment. Moreover, these different levels in BG-cortical     loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment     following treatment with dopaminergic drugs and is partially suppressed prior to and during     voluntary movements. An unanswered question is how do BG-cortical loops become so prominently     engaged in this oscillatory activity? One possible explanation is that the resonance     frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that     oscillations in this band are transmitted particularly well. This hypothesis was confirmed in     a previous series of experiments.The aim is to determine whether the resonance frequency     within BG-cortical loops is correlated to the BG-cortical coherence frequency (with 20     subjets during 24 months).   "
152727|NCT01284673|"     Neonatal anoxic-ischaemic enkephalopathy is a dramatic perinatal complication due to brain     asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal     damage and loss.      For the moment, only total or partial body hypothermia can partially prevent cell loss.     However, no treatment exists to restore neuronal functions.      Cord blood stem cells are a promising treatment for the near future. However, before     conducting a clinical trial to evaluate the safety and feasibility of autologous cell therapy     in neonatal asphyxia, in vitro characterization of the cord blood stem cell in situation of     neonatal asphyxia, compared to normal situation, is needed.      The primary objective of this study is to characterize cord blood stem cells of neonates with     neonatal asphyxia and to compare them with those from healthy newborn. The quantitative and     qualitative, functional characterization will insist on cell populations which could     potentially participate to neuronal regeneration. Secondary objectives are to assess such     characteristics in conditions of cryo-preservation, compared to fresh cell preparation   "
152732|NCT01284608|"     This is an observational, prospective, non-interventional and multi-centre study, to assess     the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose, body     fat distribution and fracture risk to ten years using FRAX model in patients with prostate     cancer. The patients will be following for 12 months   "
152733|NCT01284595|"     Study to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose     Oral Administration   "
152741|NCT01284491|"     The objective of this clinical study is to evaluate scar quality following incision with the     PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to     compare these results to equivalently-aged scars formed following incision with a standard     scalpel.   "
152742|NCT01284478|"     The purpose of the study is to determine where a sustained steroid delivery system     (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients     after Cataract Surgery   "
152743|NCT01284465|"     The purpose of this study is to assess the extent to which a culturally appropriate,     self-management intervention that combines patient education with a patient outreach liaison     strategy improves outcomes associated with type-2 diabetes among low-income diabetic women.   "
152744|NCT01284452|"     Severe sepsis/septic shock is a serious condition associated with high mortality rate.     Hydrocortisone has been recommended as a useful treatment to decrease mortality in     hemodynamically unstable septic shock patients, not response to fluid and moderate dose of     vasopressor. During the progression of severe sepsis/septic shock, multi-organ dysfunction     can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome     (ARDS) is one of the common organ dysfunction associated with septic shock. Information from     a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients'     outcome. Whether hydrocortisone can effectively prevent disease progression and death in     severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.   "
152748|NCT01284400|"     Although many studies have demonstrated the efficacy of disease management programs on     mortality, morbidity, quality of life (Qol), and medical cost in patients with heart failure     (HF), no study has focused on psychological status as an outcome of disease management in     patients with HF. Disease management could lead to the reduction of psychological distress,     thus improving the self-care ability and adherence of patients with HF. In addition, very     little information is available on the effectiveness of disease management programs in areas     other than the US and Europe.The Japanese Heart Failure Outpatients Disease Management and     Cardiac Evaluation (J-HOMECARE) has designed a randomized controlled trial to evaluate the     efficacy of home-based disease management programs compared with usual care in improving     psychosocial status, mortality, HF hospitalization, and Qol in Japanese HF patients.   "
152749|NCT01284387|"     A Phase II clinical research study to evaluate the efficacy and safety of two different dose     levels of an injectable investigational treatment (ACC-001) in subjects with Mild-to-Moderate     Alzheimer's disease. ACC-001 (vanutide cridificar) is a beta amyloid fragment attached to a     carrier protein. It is intended to help induce an antibody response against beta amyloid and     is administered as an intramuscular injection.   "
152750|NCT01284374|"     The objectives of this study are:        1. To better understand factors associated with acceptance and refusal of HPV vaccine among          parent-son pairs and the process of parent-son decision-making with respect to          vaccination.        2. To evaluate health care providers (HCPs) attitudes, implementation intentions, and          planned communication strategies with respect to HPV vaccination of adolescent boys.      Hypothesis 1: Sons will have a significant role in the process of parent-son decision-making     about HPV vaccination. The relative importance of this role will increase with the son's age.      Hypothesis 2: Pediatric HCPs will be unsure about vaccinating males and will lack knowledge     about issues related to male HPV infection and vaccination.   "
152751|NCT01284361|"     This is an unblinded, multi-center, randomized, controlled, cross-over study assessing     wheel-chair bound, male user preference and catheter characteristics of two intermittent     urinary catheters. Subjects enrolled in the study will be randomized to order of catheter     use. Individual participation will consist of approximately 1 week of product use. The null     hypothesis to be tested is there no difference between catheters.   "
152752|NCT01284348|"     The purpose of this study is to determine an effective and safe dose of ACE-011 for the     treatment of chemotherapy induced anemia (CIA) in patients with metastatic non-small cell     lung cancer who are being treated with first-line platinum based chemotherapy.   "
152753|NCT01284335|"     The purpose of this study is to determine a safe dose of LY573636-sodium when used in 5     separate combinations with an approved cancer medication for treating patients with advanced     cancer. Data from this study will be reviewed for any side effects or anti-tumor activity     that may be associated with the LY573636-sodium combination treatments.   "
152754|NCT01284322|"     The purpose of this study is to determine if fresolimumab is safe in treating people with     systemic sclerosis (scleroderma) and to investigate the effect of fresolimumab in the skin of     these individuals.   "
152755|NCT01284309|"     The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP)     in healthy subjects.   "
152756|NCT01284296|"     This study will further investigate the Masimo SpHb [FDA Approved] continuous non-invasive     hemoglobin monitor in spine surgery patients. (See NCT00792597) We will investigate the     effect of enhanced circulation to the finger (which will be attached to the sensor) following     a local injection (digital block) of lidocaine (an FDA approved local anesthetic), and assess     the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value     (tHb).   "
152782|NCT01283958|"     Identification of the pathophysiology associated with Eisenmenger's syndrome has led to the     evaluation of targeted therapies. Iloprost, a prostacyclin analogue, is one such targeted     therapy used in patients with Eisenmenger's syndrome. The purpose of our study is to assess     the effects of inhaled iloprost on patients with Eisenmenger's syndrome.   "
152783|NCT01283945|"     Co-selective inhibition of VEGFRs and FGFR has the potential benefit of blocking the two most     relevant players in tumor angiogenesis and simultaneously targeting proliferation in     FGF-driven tumors. Lucitanib is a novel dual-targeted small molecule inhibitor of VEGFR1, 2,     3 and FGFR1 showing strong anti-angiogenic and anti-tumor activity in preclinical models at     well-tolerated oral doses, with a favorable pharmacokinetic profile. These properties make it     an attractive candidate for development in humans.      This is an open-label, uncontrolled, non-randomized, PhaseI/IIa study and its primary     objective is to determine the Maximum Tolerated Dose (MTD) of Lucitanib administered orally,     once daily, on a continuous schedule over the initial 28-day cycle.      Secondary objectives are to determine the safety profile, pharmacokinetics, pharmacodynamics     and antitumour activity of Lucitanib, given as a single agent to adult patients with advanced     solid tumours.      The study consists of two phases, a dose escalation phase followed by a dose-expansion phase     at the identified Recommended Dose (RD). Eligible patients have histologically or     cytologically confirmed locally advanced or metastatic solid tumours, relapsed or refractory     to standard therapy. For the dose expansion, patients should have tumours bearing FGFR1 or     11q 12-14 amplification, assessed by FISH or CGH array, or sensitive to antiangiogenic     treatment. These latter are defined as patients who have relapsed after having experienced     stable disease (lasting at least six months) or partial response with prior treatment with an     approved antiangiogenic regimen or patients with tumour types known to be potentially     responsive to antiangiogenic agents but without such pretreatment if no antiangiogenic agents     were approved and/or available for that specific condition (e.g thyroid cancer, thymic     carcinoma).      Serial safety assessments, including evaluation of symptoms, physical examination and blood     and urine laboratory analyses are performed throughout the study. Cardiac functions and blood     pressure are monitored in consultation with a cardiologist. PK parameters are determined on     plasma samples collected during the first 4-week cycle and analyzed using a validated     LC-MS/MS method. Correlative studies include: (i) quantitative assessment of the effects of     E-3810 on tumor vasculature by DCE-MRI and DCE-US imaging; (ii) assay of angiogenesis     biomarkers i.e. soluble VEGFR2, VEGFR1, VEGF, bFGF, Collagen IV, FGF23 and PIGF(by ELISA) and     circulating endothelial and progenitors cells (CEC and CEP). Tumor response is based on     imaging according to RECIST; circulating tumor cells (CTC) are measured by the immunomagnetic     CellSearch method.      In patients with tumours bearing FGFR1 amplifications the efficacy of Lucitanib will be     formally tested according to a phase IIa design (one-stage Flaming design, H0=0.05, H1=0,30,     power 0,80.   "
164603|NCT00004029|"     Phase I trial to study the effectiveness of vaccine therapy in treating patients with     metastatic prostate cancer. Vaccines may make the body build an immune response to kill tumor     cells.   "
152758|NCT01284270|"     The purpose of this study is to evaluate whether some features of plaques in coronary     arteries predispose the heart muscle to injuries during angioplasty in patients with a     narrowing in at least one of the arteries that may need a stent placed during a heart     catheterization. Participants undergo a cardiovascular magnetic resonance imaging (MRI) study     before the heart catheterization to look for scarring in the heart muscle. During the heart     catheterization, participants undergo an intravascular ultrasound (IVUS) exam to look at the     make-up of the plaques before the stent placement and the investigators will measure the     pressures in the arteries to look at how severe the blockage is. Within 30 days after the     heart catheterization, participants will have a second MRI done to look for any new scar in     the heart muscle.   "
152759|NCT01284257|"     The MORE Observational Study follows real-world renal transplant patients with the data     resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing     detailed clinical data, the study describes recent important changes in surveillance testing     and drug therapy and relates these changes to short and long-term outcomes. Also, the study     measures patient compliance over time and details the rationale for modifications of MPA     dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide     information on era changes in transplant practices and their impact on clinical outcome, new     insights on optimizing regimens for discrete patient subsets and new perspectives on the     optimal use of MPA therapy.   "
152770|NCT01284114|"     The purpose of this study is to determine whether aliskiren is effective in the treatment of     blood pressure, hear function, renal function in elderly hypertensive chronic kidney disease     (CKD) patients.   "
152771|NCT01284101|"     The Tan EndoGlide device results in less endothelial cell trauma during insertion of the     donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared     to the Forceps.   "
152811|NCT01283581|"     The purpose of this study is to compare clinical response to the measurement techniques of     several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial     Skin and Skin Structure Infections) clinical trials   "
152760|NCT01284244|"     Stress urinary incontinence (SUI) is defined as the involuntary loss of urine with an     increase in abdominal pressure, caused either by a loss of support under the bladder neck, or     intrinsic urethral sphincter deficiency. It is a common problem in women that can     significantly impact quality of life, with up to 30% developing SUI at some point in their     lifetime.      The most commonly utilized treatments for SUI include either pelvic floor (Kegel) exercises,     or surgery. Many women find Kegel exercises unsatisfactory, but are reluctant to undergo a     surgical procedure. Also, women who are poor candidates for surgery have limited options if     Kegel exercises are unsuccessful. Over the years, there have been numerous attempts to     develop effective non-surgical alternatives for treating SUI, but the results have been     variable and the available data on efficacy limited.      A new intravaginal incontinence pessary (Uresta) has been developed for treating stress     incontinence, and is currently available in Canada via a medical distributor. The     self-positioning device is initially fitted by a healthcare provider, but then can     subsequently placed by the patient as needed. Uresta is designed to be easily inserted into     the vagina and spontaneously fall into position, providing support beneath the urethra. A     single, uncontrolled study of 21 women showed that Uresta significantly reduces urinary     incontinence measures, with no reported complications. Using questionnaires, a 47% reduction     in self-reported SUI symptoms was demonstrated. Pad weight following a pad test, an objective     assessment of urine loss, showed a 50% reduction in leakage.      This trial is intended to be a short-term assessment of the efficacy of the Uresta device,     using a placebo arm in order to remove any of the possible sources of patient biases. The     placebo (sham) group will be obtained by placing a flexible silastic ring (inactivated     Estring) high in the vagina where it will not alter urethral forces. The aim is to     unequivocally determine whether the Uresta device provides the necessary urethral support to     stop urine leakage from stress incontinence.      The hypothesis is that the Uresta device will significantly reduce urinary losses from     baseline, shown as a significant reduction pad weight following a pad test with the device in     place.   "
152761|NCT01284231|"     To determine the maximum tolerated dose and/or optimum biologic dose of MEDI-565 in adult     subjects and evaluate the safety profile in adult subjects with advanced gastrointestinal     adenocarcinomas who have no available standard or curative treatments.   "
152762|NCT01284218|"     To examine the differences in health care utilization and costs between MDD patients on     adjunctive aripiprazole therapy and MDD patients on other augmentation therapies.   "
152763|NCT01284205|"     The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as     first line treatment in patients with non-muscle invasive bladder cancer that are at high     risk for recurrence or progression.   "
152764|NCT01284192|"     This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with     advanced malignancies (solid tumors and B-cell lymphoma).   "
152765|NCT01284179|"     The primary aim is to develop and test the feasibility of a standardized digital audio     home-hypnotherapy (HHT) program for patients with refractory functional chest pain (FCP).      The secondary aims of this study are:        1. To obtain pilot data to assess the magnitude of the treatment effect of self-hypnosis in          refractory FCP for an anticipated future, larger treatment trial;        2. To determine the stability of the treatment effect of HHT in refractory FCP;        3. To assess the relationship between response to HHT and psychological factors; and        4. To assess the relationship between response to HHT and symptomatic dimensions of chest          pain (severity, frequency, and duration).        5. To assess the difference   "
152766|NCT01284166|"     This study will investigate the safety and efficacy of Triple Combination Therapy with     dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with     glaucoma or ocular hypertension who have elevated IOP on dorzolamide hydrochloride/timolol     maleate combination therapy.   "
152767|NCT01284153|"     This study has the purpose to investigate the benefit of treating breast cancer patients in     prone position. This treatment is compared to the standard technique in our center (supine     position with or without respiratory gating). The investigators want to compare the doses on     the organs at risk (heart and lungs) in the different techniques.   "
152768|NCT01284140|"     The goal of this project is to determine whether the sleep and circadian rhythms of     critically ill patients undergoing mechanical ventilation can be improved through practical     strategies that can be employed at the bedside.   "
152784|NCT01283932|"     To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release     tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets     (Wyeth Laboratories, USA) in 52 (+ 6 standby) healthy, adult, human subjects under fasting     conditions.   "
152785|NCT01283919|"     To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release     tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets     (Wyeth Laboratories, USA) in 42 (+ 4 standby) healthy, adult, human subjects under fasting     conditions.   "
152808|NCT01283620|"     The purpose of this study is to examine the effectiveness and feasibility of a modified     constraint induced movement therapy (mCIMT) intervention on upper limb function in two groups     of patients acutely post-stroke; 1) an experimental group that will participate in a 10 week     mCIMT intervention designed to improve upper limb function, in addition to usual care, and 2)     a control group that will participate in a program of usual care consisting of a     rehabilitation intervention for the affected upper limb that is dose-matched to the     experimental group.   "
164838|NCT00005414|"     To compare long-term recall of physical activity up to 15 years in the past with physical     activity reports and physical fitness levels assessed at the baseline examination.   "
152769|NCT01284127|"     Superficial siderosis is a progressive neurological disease caused by iron deposition in the     central nervous system from chronic subarachnoid bleeding. Until 2011, there has been no     effective treatment for this progressive condition that leads to hearing loss, spasticity,     weakness, loss of bowel/bladder function, incoordination, dementia and ultimately death.      Last year, we demonstrated that a lipid soluble iron chelator, deferiprone, can reduce     hemosiderin deposition in patients with superficial siderosis by MRI in as little as 3     months. As the only therapy that can improve this condition, chelation with deferiprone is     the standard of care for treatment of superficial siderosis. Now that the FDA has approved     deferiprone in the United States for thalassemia, we propose documenting the clinical effect     of deferiprone over 2 years in superficial siderosis patients. Our goal is to understand how     the clinical course of this disease is altered using standard of care chelation therapy with     deferiprone.      Patients with superficial siderosis who are taking deferiprone for chelation therapy at doses     consistent with the standard of care will be offered enrollment into this observational     study. Patients will be treated and monitored locally by participating neurologists who have     agreed to help us collect information for this study. We are interested in documenting the     clinical effect of deferiprone on hearing, ataxia and myelopathy using standardized scales     performed and documenting the effect of deferiprone on hemosiderin deposition in the CNS by     MRI, all performed according to standard of care.   "
152772|NCT01284088|"     The World Health Organization and UNAIDS cite that male circumcision can reduce the lifetime     risk of HIV infection by 60% in high risk areas such as Sub Saharan Africa.      Rwanda has a national plan to offer a voluntary circumcision program to 2 million adult men     in 2 years as part of a comprehensive HIV prevention package. To achieve this goal, the     government is continuing to study the PrePex™ device, developed to enable rapid adult male     circumcision in resource limited settings.      The study will enroll one hundred and fifty (150) persons scheduled for voluntary     circumcision. The subjects will be randomly divided into two unbalanced study arms, PrePex™     arm which will include about a hundred and twenty (100) subjects and surgical circumcision     arm which will include about sixty (50) subjects.      Study duration per subject will be 9 weeks.   "
152773|NCT01284075|"     This pilot study will be a prospective, randomized trial which will take place at the     University of Minnesota Medical Center (UMMC). Eligible patients will be identified at the     time of their first clinic visit. If selected to be involved in the study, the patients will     be randomized to one of three different groups: a Guided Imagery and Music therapy group     (GIMT) or one of two control groups.   "
152774|NCT01284062|"     This study represents the first investigation of anrukinzumab in patients with active     ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism     based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and     hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics     (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.   "
152775|NCT01284049|"     The objective of the study is to show that substitution of the usual lipid emulsion     (Intralipid 20%®) at a dose between 0.5 and 1.0 g/kg/infusion of parenteral nutrition     (n-6:n-3 ratio = 7:1) by an equivalent dose of 0.5 to 1 g/kg/infusion of another lipid     emulsion, OMEGAVEN 10%® very rich in omega-3 (n-3) (n-6:n-3 ratio = 1:7) induces regression     of PNALD due to the anti-inflammatory and anti-fibrotic effects of n-3 EFA.      Regression of liver disease will be defined by normalization of the five liver function tests     (LFT): conjugated bilirubin, gamma GT, alkaline phosphatase, AST and ALT transaminases.   "
152776|NCT01284036|"     The purpose of this study is to find the safety and side effects of investigational drug in     healthy volunteers. See how quickly investigational drug enters the bloodstream, is     distributed in the body, broken down and removed in healthy male and female volunteers. See     if your body makes antibodies to this investigational drug (how your immune system responds).   "
152777|NCT01284023|"     Acute compartment syndrome (ACS) is a complication of lower leg trauma that occurs when the     pressure inside the leg due to swelling exceeds the body's ability to provide blood to the     muscle of the leg. This condition cuts off blood flow to the leg. Left untreated, the     condition can result in devastating consequences including complete loss of function of the     lower extremity or amputation. Near-infrared spectroscopy (NIRS)-based tissue perfusion     monitors are a non-invasive means of continuously monitoring the amount of oxygen in the     tissues of an injured extremity. The device utilizes harmless red light to detect the     proportion of hemoglobin saturated with oxygen up to 3 cm below the skin surface. The purpose     of this study will be to launch the first stages of validation of this device as a diagnostic     tool for compartment syndrome, by observing this device in uninjured subjects.   "
152778|NCT01284010|"     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in blood and bone marrow samples from     patients with acute lymphoblastic leukemia.   "
152779|NCT01283997|"     The goal of this clinical research study is to see if Minocin® (minocycline) can help to     control nerve damage that causes numbness and tingling in the hands and feet (neuropathy) in     patients receiving thalidomide and/or bortezomib.   "
152780|NCT01283984|"     AZD2115 Single Ascending Dose Study   "
152781|NCT01283971|"     This randomized, parallel-group study will assess the efficacy and safety of     RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate     (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already     treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8     mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks.     All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly).     The anticipated time on study treatment is 24 weeks.   "
152786|NCT01283906|"     This study is a randomized, double-blind, sham-controlled, two-arm study conducted in     subjects receiving chemoradiation therapy for the treatment of head and neck cancer to assess     the efficacy of MuGard. The study will evaluate the ability of MuGard to reduce the symptoms     of oral mucositis. The study includes a treatment period of approximately 7 weeks depending     on the subject's prescribed radiation plan.      MuGard is a liquid that is classified as a medical device. It is a hydrated polymer system     (oral hydrogel) and is intended for the management of oral mucositis/stomatitis. When gently     distributed within the mouth, the mucoadhesive formulation results in the formation of a     protective coating over the oral mucosa. Subjects undergoing chemotherapy with radiation for     the treatment of head and neck cancer are at high risk of developing oral mucositis as an     adverse side-effect of cancer treatment. MuGard was previously shown to reduce the incidence     and severity of mucositis in head and neck cancer patients undergoing radiation therapy when     compared with data from historical control groups. The purpose of this study is to perform a     direct comparison of the effectiveness of MuGard with a control group.   "
152787|NCT01283893|"     Gastric cancer is one of the most common cancers in Korea. Having achieved excellent     long-term survival for early gastric cancer patients, there is a growing interest in     improving the quality of life of these patients without compromising their prognosis.     Laparoscopic surgery for early gastric cancer have been found to be safe and feasible with     superior short-term outcomes. Although laparoscopic gastrectomy with D2 lymphadenectomy is     being performed for patients with locally advanced gastric cancer; the completeness of the D2     lymphadenectomy during laparoscopic surgery has not been evaluate and no standardized     procedure exists. To conduct a clinical trial comparing laparoscopic D2 lymphadenectomy to     the open approach, quality control of D2 lymphadenectomy procedure is necessary.   "
154847|NCT01257581|"     The purpose of the study is to evaluate the safety and efficacy of high dose creatine and two     dosages of tamoxifen treatment in amyotrophic lateral sclerosis (ALS).   "
152788|NCT01283880|"     Metabolic acidosis is a common complication in incident renal transplant recipients.     Protracted acidosis may be associated with osteoporosis, inflammation, negative protein     balance and malnutrition, and last but not least may cause renal dysfunction. Preliminary     data indicate an increased prevalence of nephrocalcinosis in renal transplant biopsies of     incident patients presenting with metabolic acidosis. The present study aims (1)evaluate the     prevalence and type of renal tubular acidosis (RTA) in incident renal transplant recipients     and to identify clinical correlates and (2) to find associations between RTA, nephrolithiasis     and nephrocalcinosis   "
152789|NCT01283867|"     To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's     test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in     healthy, adult, human male subjects under non-fasting conditions and to assess the     bioequivalence.   "
152790|NCT01283854|"     Gestational diabetes mellitus (GDM) is one of the most common medical complications of     pregnancy and has serious health implications for both the pregnant woman and her child. In     particular, offspring of mothers with GDM have an increased prevalence of obesity, diabetes     and metabolic syndrome, perpetuating serious health consequences in subsequent generations.      Although regular exercise offers numerous benefits for both the mother and her child, its     effectiveness in preventing GDM remains to be established. It has been recently shown that     regular supervised home-based exercise may attenuate the decline in glucose tolerance in     obese pregnant women. This study aims to conduct a single-centred, multi-sited,     single-blinded randomised controlled trial examining the effect of 14 weeks of supervised     home-based exercise (commenced at 14 weeks gestation) on the recurrence and severity of GDM,     along with other aspects of maternal and fetal wellbeing.      Eligible participants (n = 200) will be randomly allocated to an exercise intervention (n =     100) or a control group (n = 100). The exercise intervention will involve three 60-minute     home-based, supervised exercise sessions each week. This type of program overcomes many of     the barriers to exercise in this population including transportation, child care issues and     embarrassment associated with exercising in a public venue. The investigators have already     shown this program to be both feasible and warmly accepted by obese pregnant women.   "
152791|NCT01283841|"     To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's     test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in     healthy, adult, human male subjects under fasting conditions and to assess the     bioequivalence.   "
152792|NCT01283828|"     This primary goals of this study are to: estimate the prevalence of Clostridium sordellii and     Clostridium perfringens carriage in the rectum and/or vagina among women of reproductive age;     estimate duration of carriage of the two clostridium species; and estimate the incidence of     carriage at 2 weeks after a negative test.   "
152793|NCT01283815|"     According to retrospective studies the conservative management of periappendicular abscess is     associated with decreased complication and re-operation rate compared with open appendectomy.     Large abscesses require percutaneous drainage. Sometimes percutaneous drainage is not     possible because of anatomical position of the abscess and surgical treatment is needed. The     purpose of this study is evaluate whether laparoscopic appendectomy is suitable for the     first-line treatment in patients with periappendicular abscess.      The hypothesis of the study is that laparoscopic management of periappendicular abscess is     suitable for the first-line treatment and it does not increase time of hospitalization or     complication rate compared with conservative management.   "
152794|NCT01283802|"     Liver surgery should be considered an echo-guided procedure to guarantee conservative but     radical resections. The investigators describe a further application of intraoperative     ultrasonography (IOUS) for studying the biliary tree during liver surgery with no need for     formal cholangiography.   "
152795|NCT01283789|"     By doing this study, researchers hope to learn the effectiveness of the combination of     Lapatinib and RAD-001 for treating patients who have progressed on previous therapies.   "
152796|NCT01283776|"     A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as     single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in     patients with multiple myeloma or lymphoma and to describe the influence of the modified     immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution     and chimerism.   "
152797|NCT01283763|"     The purpose of this study is to investigate the non-inferiority of a topical Imiquimod     therapy in patients with persistent CIN 2/3 when compared to standard therapy, i.e.     conization A randomized, controlled, non-inferiority AGO-Austria trial   "
152798|NCT01283750|"     Funded by a unique private philanthropy and public coalition through THE ASSOCIATED: Jewish     Community Federation of Baltimore, this project seeks to develop effective ways to deliver     dementia care to older adults with memory disorders who live in the community. MIND at Home     is an 18 month intervention research study whose goals are two-fold: To partner with     community organizations to help proactively identify older adults in the Baltimore community     who may need help related to memory disorders; To find out if providing person-centered,     coordinated care will help older adults with memory disorders remain at home longer, as well     other possible benefits. The investigators hypothesize that individuals with memory disorders     that receive person-centered, coordinated care will have fewer unmet dementia-related needs,     improved quality of life and function, fewer behavioral and depressive symptoms, and will be     able to remain in their homes longer compared to individuals who receive augmented usual     care.   "
152799|NCT01283737|"     This is a 1:1 randomised pilot study in 30 patients in 1 site in Helsinki, Finland.      The investigators hypothesize that function, pain, type and quality of cartilage in adult     patients with osteochondritis dissecans of the knee will be better in the DBX group compared     to the mosaicplasty group.   "
152800|NCT01283724|"     A clinical trial which was designed to demonstrate the safety and efficacy of Visanne     (approved in endometriosis for adults) in the adolescent population.   "
152810|NCT01283594|"     The purpose of this research study is to test the effect of SYN115 compared to placebo (a     sugar pill that looks like SYN115 but does not include active drug) on movement during the     on and off states as well as other symptoms that some patients with Parkinson's disease     experience. This study will also look at whether or not patients with Parkinson's disease     experience side-effects with SYN115.   "
152801|NCT01283711|"     Non-invasive, energy-based, aesthetic treatments are becoming increasingly popular among     female and male patients of all ages. Different technologies are presently available to     rejuvenate skin, including therapeutic ultrasound, lasers and intense pulsed light (IPL),     however radiofrequency has emerged as the most effective and versatile modality for the     broadest range of body and facial treatments, including non-invasive wrinkle treatment.      The apollo™ system is an RF system, based on the TriPollar™ technology. The technology is     based on three or more electrodes designed to deliver RF current focused into the skin, thus     generating heat in the dermal layer. Selective and focused electro-heating of the skin is     intended to stimulate collagen remodeling in the dermal layer resulting in non invasive     wrinkle treatment.      The apollo™ system is intended for use in dermatologic and general surgical procedures for     non invasive treatment of facial wrinkles and rhytides. This study was designed in order to     evaluate the safety and efficacy of the Apollo™ System for facial wrinkles and rhytides     treatments.   "
152802|NCT01283698|"     The aim of the study is to intra-individually compare the dose-related efficacy of LAS41004     in a Psoriasis Plaque Test (PPT)   "
152803|NCT01283685|"     Regular exercise can help patients with the lung disease, chronic obstructive pulmonary     disease (COPD). But COPD patients have a hard time with training because of their breathing.     To improve their program they can train with one leg at a time. Another way is to make their     exercise easier by breathing helium. Putting two methods, one-legged and helium, together may     improve their program even more. This project is planned to assess whether breathing helium     improves their one-legged exercise endurance. If it does, then there may be a reason for     combining one-legged exercise with breathing helium as part of their respiratory     rehabilitation program. The aim of this study is to determine whether breathing     helium-hyperoxia enables a further increase in the constant power endurance time during     one-legged exercise in ventilatory limited subjects with COPD. The null hypothesis is that     patients will have sufficient peripheral muscle limitation that ventilatory unloading using     helium-hyperoxia will be of no additional benefit to exercise tolerance. The investigators     hypothesize that patients with COPD are so ventilatory limited relative to their peripheral     muscles that helium-hyperoxia will improve their exercise endurance.   "
152804|NCT01283672|"     The objectives of this study are the following: 1) to determine the acute effect of whole     grain barley on risk factors of cardiovascular disease compared to a diet low in whole grain,     and 2) to compare the effects of whole grain barley to those of whole grain oats to determine     if the response to these two grains is similar.   "
152805|NCT01283659|"     Background: The prevalence of heart failure (HF) is rapidly rising in industrialized and     developing countries. Though invasive coronary angiography (ICA) remains the gold standard     for anatomical assessment of coronary arteries and luminal stenoses in these patients,     alternatives have been sought. Computed tomographic coronary angiography (CTA) has emerged as     an accurate non-invasive diagnostic tool for CAD and has been demonstrated to have prognostic     value. Whether or not CTA can be used in patients with HF for diagnosis and to guide patient     investigations and management is unknown. Acknowledging the aging population in     industrialized counties, the increasing burden of healthcare and growing prevalence of HF,     there is a need to identify non-invasive diagnostic tests that are cost-effective, readily     available, safe and of sufficient accuracy to risk stratify patients and guide investigations     and management.      Methods: The proposed randomized controlled trial (RCT) will evaluate the clinical utility of     computed tomographic coronary angiography (CTA) and investigate its potential benefit on     resource utilization and health economics in patients with progressive or newly diagnosed     heart failure (HF) of unknown etiology (i.e. ischemic versus non- ischemic) or in whom the     definition of coronary anatomy is required for diagnosis and management. The experimental     algorithm will be compared to invasive coronary angiography (ICA)      Analysis of composite clinical events and major adverse cardiac events will be performed to     determine the impact of these strategies upon patient outcomes. Accuracy of CTA in detection     of coronary anatomy and obstruction will be assessed in patients undergoing ICA. It is     expected that CTA will be a more cost-effective strategy for diagnosis; yielding similar     outcomes with fewer procedural risks and improved resource utilization.   "
152806|NCT01283646|"     Lack of appetite is one of the most common reasons for visits to pediatric clinics.The     symptoms usually manifest after weaning when they are introduced into the diet of infant     foods containing salt.Is normally used to cyproheptadine in conjunction with vitamins C and B     and also vitamins complex.   "
152807|NCT01283633|"     In recent years, robotic devices are becoming more and more common in medical practice. Such     devices provide an effective way to communicate within a clinical setting, but recent studies     have shown far more diverse uses for these robots, ranging from training future surgeons to     diagnoses of patients. In the investigators study, the investigators would like to     investigate whether it is effective to employ robotic devices in the administration of     neurostimulation treatment. It is the investigators hypothesis that the introduction of     robotic devices will only yield minimal if any inaccuracies in a standard neuromodulation     treatment protocol. In addition, the investigators also predict a high satisfaction rating     from all participants involved in conditions involving the robot.   "
152882|NCT01282658|"     Irinotecan (CPT-11) is now widely used as the first-line chemotherapy for mCRC. There were 4     key enzymes for CPT-11 metabolizing, CYP3A4, UDP-glucuronosyltransferase,     carboxylesterase(CES), and ATP-binding cassette (ABC) transporters. Genetic variations of     those enzymes may cause the heterogeneity in safety and efficacy of CPT-11. The aim of this     study is to figure out the correlation between the genetic polymorphism and the drug     response.   "
152809|NCT01283607|"     Yearly, 15,000 Dutch in vitro fertilization (IVF) cycles are performed for subfertility with     a pregnancy rate of 26%. A failed cycle has great emotional impact; 20-25% of the women has     relevant forms of depression/anxiety even after 6 months. For such maladjustment a risk     profile has been identified and translated into a screening tool. Identification of women at     risk enables a timely and tailored (individual's needs) cognitive behavioral therapy (CBT),     which reduces more serious maladjustment and corresponding costs.      Aim: To investigate the effectiveness of an e-health CBT (digital coaching, Digicoach) in     women ongoing IVF and having been screened at risk.      Design: A single-centered randomised controlled trial comparing Digicoach (intervention) with     standard care (control).      Digicoach: an e-health CBT with 4-12 weekly sessions starting before an IVF cycle, following     a woman's IVF course and covering in modules the main problems: depressed mood, anxiety,     strong focus on child wish and acceptance.      Main outcome measures: anxiety and depression occurrence rate 3 weeks after an unsuccessful     IVF cycle. Secondary outcome measures: 1. (para)medical consumption, 2. quality of life, 3.     productivity loss and 4. IVF outcome. Data are collected by questionnaires, diaries, medical     record audit and page view registrations.      Process evaluation: Individual's use (e.g. module progress, completion rate), experiences,     (e.g. satisfaction and usability) and potential barriers for implementation are evaluated.      Economic evaluation: studied during the Digicoach exposures from a societal perspective.     Incremental costs (costs/%avoidance of depression/anxiety) are determined by comparing both     study groups.      Power/data analysis: To detect a 29% difference in the depression/anxiety occurrence rates     (alfa=0.05 and beta=0.80) 58 unpregnant IVF women are evaluated.   "
154850|NCT01257542|"     15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the     number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.   "
152812|NCT01283568|"     GAMALINE is already register for PMS and HIPERICIN as antidepressive drug. Both plant     extracts. The investigators will try the mixture and see if the vasomotor symptoms will     disappear. The investigators expect that together all symptoms will be covered better than     Gamaline alone. The investigators will run for 180 days measuring at T0, T1 and T6 (starting     point, 30 days and 180 days).   "
152813|NCT01283555|"     The primary objective of this study is to compare the effect of two vaginal applicators,     delivering the candidate microbicide Tenofovir, on symptoms and signs of irritation of the     external genitalia, cervix and vagina as seen on colposcopy after seven days of twice daily     use.      The secondary objectives are to:        1. Evaluate and compare the dosing accuracy and precision of the user-filled applicator and          pre-filled applicator with the candidate microbicide, Tenofovir.        2. Compare the acceptability of the user-filled applicator with the pre-filled applicator.   "
152814|NCT01283542|"     This study will assess pasireotide LAR efficacy on patients with non-functioning pituitary     adenomas concerning tumor growth.   "
152815|NCT01283529|"     Pulse induced continuous cardiac output (PiCCO) is an established technology for measurement     of advanced hemodynamic variables in critically ill patients. PiCCO is approved and designed     also for use in children, but there is a lack of documentation of reference values in     children not suffering from a critical illness. The goal of this study is to establish such     values.   "
152816|NCT01283516|"     This study will assess the safety and efficacy of LDK378 in adult patients with genetic     abnormalities in anaplastic lymphoma kinase (ALK)   "
152817|NCT01283503|"     In this study, BKM120 will be administered to adult patients with advanced solid tumors whose     disease has progressed despite standard therapy or for whom no standard therapy exists. The     trial will confirm the safety and tolerability and determine the maximum tolerated dose (MTD)     of BKM120 in Japanese patients.   "
152818|NCT01283490|"     The Dental Anesthesia Sonophoresis Device (DASD) is a novel device that is intended to reduce     the discomfort associated with puncturing the oral mucosa. DASD is a portable,     battery-powered device that simultaneously generates ultrasonic energy and sonic vibration in     a small applicator head that can easily reach and adapt to injection sites in the oral     cavity. The ultrasonic energy provides a sonophoretic effect on the oral mucosa, generating     micro channels through the lipids between the keratinized cells that make up the stratum     corneum. Once the benzocaine has permeated the stratum corneum, it is quickly absorbed into     the soft tissue desensitizing the area and reducing the perception of pain caused by the     trauma of puncturing soft tissue. Methods: A split-mouth model using 50 healthy subjects from     the ages of 18 to 50 will undergo needle puncture of the maxillary mucobuccal fold at the     canine eminence. Prior to the injection there will be randomized application of 20%     Benzocaine with a device which is a modified battery operated tooth brush that in appearance     and sound is similar to the DASD which only produces sonic vibration which will be known as     (SV) or 20% benzocaine with application of the DASD device, that produces ultrasonic as well     as sonic vibration. Subjects will rate their pain according to the Visual Analog Scale     (VAS).The purpose of this study is to evaluate whether sonophoresis applied using the DASD     will eliminate the pain associated with intraoral injections within one minute of     application.      Null Hypothesis (Ho): There is no difference in the perception of pain when the DASD is used     compared to topical anesthetic applied with sonic vibration.      The Alternative Hypothesis (Ha): There is a difference in pain perception when the DASD is     used for application of topical anesthetic compared to topical anesthetic applied with sonic     vibration.   "
152819|NCT01283477|"     Intrathecal morphine is commonly used for pain relief in caesarean delivery. Side effects     such as itch (pruritis) and nausea & vomiting are common and have been shown to be the most     common cause for dissatisfaction. The incidence of pruritis is 74% even with current     available medications. Acupuncture has been shown to be effective for morphine related side     effects but has not been evaluated for prophylaxis of itch in pregnant population.      PRIMARY OBJECTIVE:      Acupuncture at LI 11 reduces the incidence of pruritis after elective caesarean section under     spinal with intrathecal morphine   "
152820|NCT01283464|"     The purpose of this study is to assess the comparative efficacy of retinol 1.0% and tretinoin     0.02% in minimizing wrinkles, discoloration, roughness, and other signs of moderate to severe     photodamage. Our hypothesis is that both products will be of comparable benefit.   "
152839|NCT01283217|"     Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but     it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase     I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for     advanced gastric cancer achieved response rates of 46~56% and a median survival time of     14.0~14.3 months.      Based upon this background, the aim of this study is to detect a significant increase in 3     year DFS of disease for the test group (DS) relative to the Control group (SP).   "
152883|NCT01282645|"     The primary objective of this retrospective study is to evaluate the percentage of patients     with device related adverse events (infection, rejection, dislocation, fracture of the     implant) in the first 24 months after implantation.   "
152821|NCT01283451|"     Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring     tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS).     Placement of these sensor pads on the surface of the skin must be such that light penetrates     the intended compartment without inadvertently obtaining measurements of an adjacent     compartment. The objective of this study is to examine whether the NIRS measurements of each     compartment truly represent the tissue perfusion of the intended compartment, as indicated by     the predictable decrease in muscle oxygenation of a given compartment in response to muscle     fatigue. The investigators hypothesize that the tissue oxygenation values of the stimulated     compartment will significantly decrease following muscle stimulation, indicating that the     intended muscle compartment was successfully isolated. Additionally, the investigators     hypothesize that NIRS values of unstimulated muscle compartments will not change from     baseline.   "
152822|NCT01283438|"     A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction     with limited discectomy, compared to limited discectomy alone, with regard to preventing     reherniation and the recurrence of pain or dysfunction.   "
152823|NCT01283425|"     The study is an open-label, randomized, two-period crossover study. Up to one hundred and     twenty (120) subjects with type 1 diabetes mellitus (T1DM) who use the MiniMed paradigm     insulin pump, who meet the inclusion/exclusion criteria and who provide written Informed     Consent will be enrolled in the study. The aim of the study is to examine the safety of the     InsuPatch device in a home use setting. Mild Hypoglycemia,hyperglycemia and Adverse events     will be compared between two phases of the study : 3 months with the use of the device and 3     months without the use of the device.   "
153594|NCT01273363|"     To assess asthma control in Russian patients according to the new criteria provided in the     international guidelines and identify pharmacological approaches that provide a higher level     of overall asthma control   "
152824|NCT01283412|"     Postoperative agitation (hyperactive delirium) is common following major surgery(incidence     was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate     when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine     is useful on reducing postoperative delirium. The hypothesis of present study: intraoperative     application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than placebo for     reducing of early postoperative delirium and increase postoperative quality of recovery     within 24 postoperative hours.   "
152825|NCT01283399|"     This observational study will assess the efficacy and safety of combination of rituximab     (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA)     who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in     routine clinical practice. Data will be collected from participants for 12 months after the     first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.   "
152826|NCT01283386|"     This multi-center, randomized study will compare the efficacy and safety of MabThera     (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil     in patients with previously untreated B-cell chronic lymphocytic leukemia and unfavourable     somatic status. Patients will be randomized to receive Mabthera (375 mg/m2 intravenously [iv]     Day 1 of Cycle 1, 500 mg/m2 iv Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 iv or 32     mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 iv or orally Days 1-3) or with     chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study     treatment is 24 weeks.   "
152827|NCT01283373|"     This is a Phase I, multicenter, open-label, dose-escalation study of DSTP3086S administered     as a single agent by intravenous (IV) infusion to patients with metastatic     Castration-Resistant Prostate Cancer (CRPC).   "
152828|NCT01283360|"     After completing a screening evaluation, 280 eligible participants, including 40 sex workers,     will be enrolled into Stage 1A of the study during which they will undergo a baseline medical     evaluation for both history and presence of STIs and anorectal health pathologies or     injuries, as well as a detailed Web-based baseline behavioral assessment. The first 140     eligible participants, including 20 sex workers, reporting at least one occasion of     unprotected RAI in the previous 3 months will be invited to enroll into Stage 1B. In Stage 1B     participants will apply the universal placebo gel (HEC) rectally prior to each episode of RAI     over a 3-month period, reporting each use via a phone reporting system; they will complete a     Web-based questionnaire and take part in a video teleconference at the end of the 3 months.     The first 24 eligible participants completing Stage 1B will be invited to enroll in Stage 2.     The subset of sex workers who took part in Stages 1A and 1B will terminate participation at     the end of 1B. Eligible participants will be randomized to receive either tenofovir 1% gel or     HEC placebo gel as part of Stage 2, the Phase 1 safety study. Following a baseline visit,     participants will return to the clinic, where a single dose of the study gel will be     administered. Within approximately 30 minutes, rectal swab and rectal biopsy specimens will     be obtained via anoscopy. After a one-week recovery period participants will return to the     clinic for assessment. If no significant adverse events (AEs) are reported they will begin to     self-administer once-daily outpatient doses of the study gel for 7 days, after which they     will return to the clinic for evaluation and specimen collection.   "
152829|NCT01283347|"     The primary objective of this protocol is to analyze the sensitivity and specificity of     18F-DTBZ PET to the differential diagnosis of Parkinson's Disease (PD) and normality.     Secondary, the investigators will analyze the correlation between the 18F-DTBZ binding and     the severity of disease of PD and the role of 18F-DTBZ PET in the monitoring disease     severity.   "
152830|NCT01283334|"     The purpose of this study is to test the drug RAD001 in combination with other chemotherapy     drugs, Carboplatin and Cetuximab. Because RAD001 has not been used in this combination     before, it is not clear which dose will be best when used in combination.      The investigators will test the safety of RAD001 in combination with Carboplatin and     Cetuximab and see what effects (good and/or bad) it has on your cancer, and find the highest     dose of RAD001 that can be given without causing bad side effects. The doses of Carboplatin     and Cetuximab will not be varied as both these drugs are considered to be part of the current     standard of care for patients with your condition.   "
152840|NCT01283204|"     This study is to evaluate the antitumor activity (i.e. progression free survival, overall     survival, response rate, etc), safety and quality of life in patient with recurrent or     metastatic gastric cancer during 4-regimen (i.e. SP, FL/Tax, FL/Doc, FOLFOX) based     chemotherapy. In addition, it is to evaluate efficacy and adverse events of anticancer agents     according to the results of pharmacogenetic study.   "
152841|NCT01283191|"     While physical activity has been associated with decreased craving and increased abstinence     rates in smokers, few published studies have examined the effects of exercise on recovery     from other drugs such as cocaine. One factor that has impeded such research has been low     levels of patient compliance with exercise protocols. One robust strategy for promoting and     maintaining behavior change is contingency management or Behavioral Incentives (BI). BI     delivers incentives (prizes, vouchers) contingent upon target behaviors such as cocaine     abstinence (Higgins et al., 1994); treatment attendance (Svikis et al., 1997) and other     pro-social behaviors (Kirby et al., 1998). While the literature is replete with studies     demonstrating the benefit of BI compared to control conditions (Stitzer & Petry, 2006), the     translation of BI methods from research to clinical practice has met with some resistance.     Contributing factors include philosophical differences (e.g., counselors feel extrinsic     reinforcement undermines recovery) and practical barriers (e.g., monetary costs of incentives     may be prohibitive). The latter concern was addressed by Petry (2005) who developed the fish     bowl method, which uses escalating variable ratio procedures to reduce per patient costs of     BI with similar effect sizes.      As a Stage 1 behavioral therapies development grant (Rounsaville et al., 2001), the primary     aim of this research is to pilot test a BI intervention designed to promote regular physical     activity in a sample of women receiving inpatient treatment for SUDs. The target behavior,     physical activity, will be objectively defined as 30 minutes of observed treadmill walking at     any intensity 3 days/week at Level 1, and 30 minutes of higher intensity physical activity     that meets ACSM criteria for moderate exercise Level 2. Specifically, a pilot randomized     clinical trial will compare rates of physical activity over a 6 week study period in a sample     of N=50 women with Cocaine Dependence. All participants will complete baseline assessment,     attend a 45-min Health and Fitness (HF) education group, followed by random assignment to     either the experimental (BI) or control (C) groups, with equal daily access to on-site     treadmills. Those randomized to BI, however, will also be eligible 3 days/week, to receive     incentives for completing 30 minutes of treadmill walking.      Incentives will be dispensed using Petry Fish Bowl methods. Women assigned to the BI group     will receive behavioral incentives (in the form of gift cards or prizes) for completing their     scheduled exercise sessions (Level 1), and have the opportunity to earn bonus draws for     meeting moderate intensity exercise criteria, as specified by ACSM (2007, revised) guidelines     (Level 2). In Level 1, the number of tokens participants can draw from the gym bag (present     study equivalent to fishbowl) at each visit will be linked to exercise session attendance,     with consistent attendance resulting in greater number of draws. In Level 2, the number of     tokens a participant can draw from the gym bag will be linked to the intensity of the     participant's exercise. Specifically, beginning in Week 2 of the study, participants will be     re-evaluated for exercise capability. Those who pass the safety screen will be encouraged to     exercise at a higher intensity, and those who do not will be re-evaluated until they obtain     safety clearance. Once cleared, if the participant meets criteria for moderate exercise     during her scheduled session, then she will be allotted a bonus draw (Level 2) for meeting     Level 2 criteria, in addition to the escalating number of draws she would received for     scheduled exercise session completion (Level 1).      Scheduled treadmill walking will be monitored and recorded for both BI and C group women.     Follow-ups will occur at study midpoint and completion (3 and 6 weeks post-randomization,     respectively), and at 4 weeks post-discharge. Assessments will focus on drug craving, mood,     stress, motivation/self-efficacy, and physical health and well being. The investigators     hypothesize that women in the BI group will complete more treadmill sessions and spend more     time treadmill walking than those in the C group. As a Stage 1b therapy development RCT,     study data will be used for effect size estimation in preparation for Stage 2 RCT. This     dissertation proposal will provide benchmark data on the utility of BI for promoting physical     activity. Further, it will promote exercise compliance, allowing scientists to better     evaluate potential benefits of physical activity on treatment outcomes in women with SUDs.   "
152831|NCT01283321|"     Heart surgery involving valve replacement often involves the use of the heart-lung machine     for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet     transfusion has been the primary therapy to treat bleeding after this type of procedure. More     recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring) was     shown to reduce bleeding and blood product use (plasma or platelets) after heart surgery. The     objective of this trial is to demonstrate the clinical equivalency and economic utility of     using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative bleeding in     patients in lieu of platelet transfusion.      Purified fibrinogen concentrate has been approved by FDA, and it has been used for the     treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary causes     (e.g., afibrinogenemia). Compared to the transfusion of platelets which may be associated     with volume overload, bacterial/viral infection, immunological effects and excess blood     clotting, purified fibrinogen has several advantages. First, it contains no liquid plasma     allowing for low volume infusion. Several viral inactivation/reduction steps are used to     prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white blood     cells are contained in the fibrinogen concentrate; therefore transfusion reactions are rare.     Although platelet transfusion is widely used after heart surgery, there has been no     randomized study to endorse this practice. In this study, patients undergoing heart valve     replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen     concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if     there is evidence of significant microvascular bleeding. Fifteen minutes after the initial     treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will be     treated with blood transfusion per institutional standard of care.      The primary endpoints for this study are the hemostatic condition of the surgical field and     24-hour total of blood product transfusion.   "
152844|NCT01283152|"     This study is being done to find out if the laxative polyethylene glycol (also known as     GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver     disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In     this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more     effective than lactulose on neurocognition (memory and thinking skills) and determine if it     decreases the hospital stay.   "
154868|NCT01257308|"     We wants to analyse the EML4-ALK mutation rate in the patients who have non-small cell lung     cancer.   "
152832|NCT01283308|"     People from the Indian subcontinent are more likely to get diabetes, even at younger ages.     The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized trial     if a culturally specific, community-based lifestyle and metformin (for individuals who do not     respond to lifestyle change alone) intervention for men and women living in Chennai, India     can effectively prevent type 2 diabetes in high-risk individuals. Lifestyle interventions are     programs that seek to prevent disease by promoting changes in health behaviors, improved     diet, increased physical activity, and weight loss. The results of this program will be used     to make policy and public health recommendations, which will result in broader diabetes     prevention efforts. The research team hypothesizes that this program will result in     improvements in health (diabetes prevention, weight loss, and improvements in other markers     of chronic disease) for intervention participants compared to participants in the control arm     of the study.   "
152833|NCT01283295|"     The purpose of this study to develop a well-characterized library of blood, biopsy tissue,     and urine samples from transplant patients. Subjects without transplants will also be     enrolled for comparison. Samples will be used to study the characteristics of patients     undergoing transplantation that influence their response to transplant therapies and their     reactions to drugs used in transplantation. This knowledge is important as it helps     physicians design new drugs and tailor transplant therapies to the individual thereby     reducing the side effects. In this study, people will be asked to donate blood, biopsy tissue     and urine. Donation of these samples will not influence patients' treatments. These samples     will be tested using a variety of biological tests to better understand how immunosuppressive     drugs change the various components of the immune system. The tests will be for research     only; no changes in an individual's treatment will be based on the results of tests performed     in this study. If there is extra sample, the sample will be stored for use in other testing     at a later date. The ultimate goal is find the right combination of medications for each     individual patient while keeping their new organ working well. This study is a first step in     that direction by perfecting tests used to characterize a patient's immune system   "
152834|NCT01283282|"     The investigators would like to investigate whether clopidogrel will help lower the level of     harmful markers in patients with coronary artery disease, and at the same time will help     increase the cells that are useful in repairing the damaged blood vessels. The investigators     will give half of the patients clopidogrel and the other half a sugar pill, placebo, and     check the levels of these markers and helpful cells in each group. At the same time the     investigators will check how well these patient's blood vessels work using ultrasound imaging     of the forearm to see how blood vessels relax and tonometry to see how stiff the patient's     blood vessels are. After 6 weeks of drug therapy, the patients will switch to the other drug     and these same tests will be performed after an additional 6 weeks of therapy. The drug taken     by the patient will not be known to the patient or the researchers. The patients will     continue on their prescribed medical therapy during the duration of the 12 week study.   "
152835|NCT01283269|"     Mild Cognitive Impairment (MCI) is often an early manifestation of Alzheimer's disease (AD).     The ability to identify MCI has led to hope that health prevention models might work in AD as     they have in cancer and heart disease. Interventions which help sustain functioning in MCI     may delay progression to a clinical AD diagnosis. To date, interventions aimed at maintaining     functioning in MCI have been pharmacologic in nature. The efficacy of these medications in     MCI is controversial, and those with MCI are also often interested in other activities they     can do to manage their memory loss.      When an individual is noted to have memory difficulties or MCI, a recommendation is often     given for the patient to begin taking notes/using a calendar to help with memory or do     cognitively stimulating activities. However, there is currently little instruction about     how/what specific activities one should do and how effective they may be. The overall goal of     this pilot project is to refine delivery of the Memory Support System (MSS)as a formal     compensatory program for memory loss in MCI. Enrollment and retention data will be carefully     investigated across 6 week and 10 day intervention groups. The investigators will compare     participant adherence to the notebook training in the 6 week and 10 day versions of the     intervention to the computer activity group. The investigators will also collect data on the     clinical efficacy of the notebook and computer training to investigate if these interventions     can sustain/improve functional level. Long term goals for this project also include delaying     relocation for persons with MCI who may progress to dementia, thus not only improving the     lives of these individuals, but also reducing health care expenditures.      The investigators will recruit a total of 60 individuals with MCI and their 60 program     partners across all three sites for this project. At least 16 of these pairs will be     recruited at Emory University (maximum of 20 pairs/40 individuals anticipated). The     investigators will randomly assign participants to the 6 week notebook or computer training     or 10 day notebook or computer training. All participants will also receive patient education     regarding MCI and cognitive health.      Subsequent compliance with the MSS will be examined at 3 months, 6 months, and then annually     following the intervention. Outcome measures will provide a detailed, multi-modal assessment     of participants' functional level, overall cognitive functioning, mood, and self-efficacy, as     well as caregiver burden and mood.   "
152836|NCT01283256|"     The purpose of this study is to evaluate the safety and efficacy of zonisamide in the     treatment of adult patients with partial, generalized or combined seizures.   "
152837|NCT01283243|"     This is a prospective cohort single center study for assessment of normal value of acoustic     radiation force impulse elastography and fibroscan in HIV patients without abnormal liver     function and chronic liver disease.   "
152838|NCT01283230|"     This is a prospective cohort Study for evaluation of liver fibrosis staging with acoustic     radiation force impulse elastography in patients with chronic liver disease and healthy     liver/kidney donors.   "
152856|NCT01282996|"     The purpose of this study is to compare the influence of a lung protective ventilation with     conventional ventilation on postoperative complications following major abdominal surgery.   "
152842|NCT01283178|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans     and treatment-planning systems may help in planning radiation therapy. Drugs used in     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving radiation therapy     together with cisplatin may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of intensity-modulated     image guided adaptive radiation therapy when given together with cisplatin in treating     patients with locally advanced head and neck squamous cell cancer   "
152843|NCT01283165|"     The main objective of the project was to determine the effect of integrated school based     deworming and health education on prevalence and morbidity due to co-infection infection with     schistosomiasis, STHs and malaria among primary school age children living in rural and     farming areas in Zimbabwe      There is need for regular school based de-worming and health education programs for the     helminths-Plasmodium co-infections in primary schoolchildren living in rural and commercial     farming areas in Zimbabwe   "
152846|NCT01283126|"     The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy     individuals and how well changes in (interstitial) tissue glucose levels correlate with     changes in cognitive function as compared to blood glucose levels.   "
152847|NCT01283113|"     The main aim of this study is to compare 2 different measurements of visceral fat that can be     easily used in clinical practice (waist circumference versus bioelectric impedance) in     relation to known risk factors of coronary artery disease in a large cohort of patients with     type 2 diabetes and with a BMI range between 20-45 kg/m2   "
152848|NCT01283100|"     This is a single-center, open-label, three-period, fixed-sequence cross over study in healthy     adult subjects. A total of approximately 16 healthy subjects will be enrolled to provide data     from 12 evaluable subjects. Subjects will have a screening visit within 30 days prior to the     first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the     last dose of study drug. There will be a washout period between Period 1 and Period 2 but no     washout between Period 2 and Period 3. Day 1 of Period 3 will be the day after Day 5 of     Period 2.   "
152849|NCT01283087|"     The purpose of this study is to find out whether patients receiving spinal anesthesia     containing lidocaine and sufentanil get transient neurological symptoms.   "
152850|NCT01283074|"     This observational, multi-center, open-label study will evaluate the prognostic factors of     long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with     HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.   "
152851|NCT01283061|"     The objective of this study was to compare the relative bioavailability of zafirlukast     tablets 20 mg with that of 'ACCOLATE®' tablets 20 mg (zafirlukast tablets 20 mg) in healthy,     adult, human, subjects under fasting conditions and to monitor safety of subjects.   "
152852|NCT01283048|"     BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in     laboratory experiments and information from those research studies suggests that this drug     may help to slow the growth of renal cancer cells. In this research study, the investigators     are testing the safety to BKM-120 at different dose levels. The investigators will also be     studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of     kidney cancer.   "
152853|NCT01283035|"     Akt inhibitor MK2206 is a drug that may stop cancer cells from growing by blocking a protein     called protein kinase B (AKT) inside the cell. AKT interacts with other proteins in the cell     that are part of the P13K/AKT pathway, a pathway that is know to play a role in the growth of     cancer cells. Mutations in P13K or in AKT, or changes in another protein called phosphatase     and tensin homolog (PTEN) in this pathway can lead it to become more active than is normal.     This study investigates how effective MK-2206 is in treating ovarian, fallopian tube, or     primary peritoneal cancer where there are mutations in P13K or AKT or low levels of PTEN.   "
152854|NCT01283022|"     The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for     the MVI 200 in women requiring cervical ripening and induction of labor.   "
152855|NCT01283009|"     The goal of the study is to determine whether providing early treatment with a glucocorticoid     drug, called methylprednisolone, will improve survival in critically ill patients with severe     community-acquired pneumonia (CAP). Pneumonia develops when bacteria and other agents invade     the lungs. The body's immune system creates a response to produce inflammation to kill the     bacteria. A moderate amount of inflammation is beneficial. But, in patients sick enough to be     admitted to the ICU, inflammation is frequently out of control. When the body cannot regulate     inflammation vital organs (brain, heart, lung, kidney, liver) may be damaged, contributing to     death or residual organ damage for those who survive. Glucocorticoids help reduce     inflammation. Recent studies have shown that when the body is unable to produce sufficient     amounts of glucocorticoids, inflammation can get out of control. Under these circumstances,     glucocorticoids given in small doses may help aid the body's ability to reduce inflammation     and improve recovery. In a small preliminary trial, glucocorticoid treatment, in addition to     standard antibiotic treatment, sped up recovery from pneumonia. It also decreased the length     of hospital stay, and increased survival. This Cooperative Studies Program study will be the     first large-scale, prospective, randomized clinical trial evaluating whether or not this     treatment improves recovery.      In this study, at each site, patients with severe CAP will be assigned to one of two     treatment groups. One group will receive methylprednisolone and the other will receive a     placebo (an inert substance that will look like the drug). The investigators have chosen a     total duration of treatment of 20 days (7 days full dose followed by slow reduction over 13     days) to prevent relapse of inflammation and allow the body to recover its own ability to     produce glucocorticoid. All patients will also receive standardized management of CAP in     accordance with current practice guidelines. The study will take into consideration when     assigning the treatment each participating site, and whether or not the patient requires     mechanical ventilation at the time of assignment. Patients will be followed clinically for     180 days. The primary outcome is all cause 60-day mortality. Secondary outcomes are (1)     in-hospital morbidity-mortality, including ventilator-free days, multiorgan dysfunction     syndrome (MODS)-free days, duration of ICU and hospital stay, and hospital discharge; and (2)     posthospital discharge morbidity-mortality, including cardiovascular complications,     functional and general health status in the first 180 days, rehospitalization, and mortality     at 1 year. Serial blood samples will also be collected and stored for future translational     research relating longitudinal inflammation markers to clinical outcomes.      This study will advance knowledge on the relationship between inflammation and long-term     outcome in severe CAP.   "
152857|NCT01282983|"     Dietary fiber (commonly called bulk or roughage) is the edible nondigestible component of     carbohydrate and lignin naturally found in plant food; however, bacteria in the lower gut may     metabolize part of it. Epidemiological studies have found that fiber intake in the population     is below the suggested recommendations. The beneficial effects of the fibers in human health     are recognized. The regular intake of dietary fiber has an important role in the intestinal     function increasing the intestinal fecal and reducing the transit time along the intestine;     collaborates with the LDL-cholesterol plasmatic reduction by increasing fecal excretion of     cholesterol and bile acids, decreases postprandial glucose in healthy, diabetics and insulin     resistant people, reduces the risk for developing certain cancers, promotes satiety, helps     with weight loss, and exerts immunomodulatory effect. However, fiber intake may be associated     with adverse effects such as flatulence, bloating, cramps, and daily consumption of orange     juice to bring digestive problems associated with acidity and heartburn, epigastric burning.     Then it becomes of interest to study the tolerance of a new orange juice product fortified     with mixed fibers (fructooligosaccharides, resistant dextrin, polydextrose and lactulose).   "
152858|NCT01282970|"     The objective of this study is to investigate safety, tolerability, pharmacokinetics and     pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days   "
152871|NCT01282801|"     The objective of this study was to compare the rate and extent of absorption of venlafaxine     hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference)     administered as 1 x 150 mg extended-release capsule under fed conditions.   "
153563|NCT01273766|"     RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions.      PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood     transfusions in patients with hematologic malignancies.   "
152859|NCT01282957|"     The primary objective of the study is to assess the effect of financial incentives on the use     of home health monitoring devices among high-risk patients. In addition, there are three     secondary objectives: (1) obtain preliminary evidence regarding whether the monetary value of     incentives has a differential effect on the use of home health monitoring devices; (2)     identify potential barriers that prohibit regular use of home-based health devices using     qualitative data; and (3) assess the usability of a newly developed web portal and its     feasibility for future randomized clinical trials aimed at changing health-related behaviors.   "
152860|NCT01282944|"     The goal of this pilot randomized controlled trial is to evaluate whether financial     incentives and peer networks delivered through a novel computer platform utilizing a digital     pedometer-internet interface can effectively encourage sustained increases in walking among     older adults.   "
152861|NCT01282931|"     The goal of the study is to understand the meaning of progression-free survival for women     with metastatic breast cancer and to use this understanding to create and distribute a new     questionnaire to assess the effect progression has on a woman's functioning and well-being.   "
152862|NCT01282918|"     The purpose of the NORDIC ICD study is to evaluate whether ICD implantation without     intra-operative DF testing is non-inferior to ICD implantation with intra-operative DF     testing regarding the efficacy of the first ICD shock for the treatment of true spontaneous     ventricular tachyarrhythmias.   "
152863|NCT01282905|"     The purpose of this study is to evaluate the relation between sulphide detoxification and     butyrate metabolism at the level of gene expression and enzyme activity in ulcerative colitis     patients and healthy controls.   "
152864|NCT01282892|"     Visceral fat or peri-omental fat is increasingly associated with metabolic syndrome, a     condition carrying a high risk of coronary artery disease. The independent role of Visceral     Fat in cardiovascular risk remains unclear.      Patients with excess of visceral fat and NAFLD patients will have higher prevalence of     coronary atherosclerosis plaques independently by metabolic syndrome diagnosis. Suggesting     that the presence of visceral fat and/or fatty liver will be considered an important     condition to optimize the cardiovascular risk stratification   "
152865|NCT01282879|"     Antifungal prophylaxis should be used in patients being treated with glucocorticoids for     graft-versus-host disease (GVHD) following allogeneic hematopoietic stem-cell transplantation     (HSCT). Although fluconazole has been widely used as an antifungal prophylactic agent after     allogeneic HSCT, fluconazole prophlaxis only shows a limited protective role against IFIs, is     not effective against invasive aspergillosis. In addition, NCCN guideline of the prevention     and treatment of cancer-related infections recommends antifungal prophylaxis in patients with     significant GVHD until resolution of GVHD using Posaconazole, Voriconazole, Echinocandin, or     Amphotericin B. However, under the National Health Insurance System, none of the drug can be     given prophylactically except itraconazole oral solution against IFIs. Itraconazole oral     solution shows excellent bioavailability and good efficacy against aspergillus and     fluconazole resistant candida infection.Based on these findings, we will perform prospective     multicenter study evaluating the efficacy, safety and long-term outcomes of itraconazole oral     solution prophylaxis against IFIs in patients treated with systemic corticosteroids for GVHD     after allogeneic HSCT.   "
152866|NCT01282866|"     The objective of this clinical study is to verify hair count reduction, associated     comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed     (HS) handpieces for temporary hair removal and permanent hair reduction. It is anticipated     that the larger treatment size of the HS handpiece will result in faster treatment of larger     areas; and that the lower energy levels will result in greater comfort.   "
152867|NCT01282853|"     Rapid urease test (RUT) is the most commonly used biopsy-based method to diagnose     Helicobacter pylori (Hp) infection because of its simple, rapid and accurate characters.     However, its sensitivity was reported to decrease during ulcer bleeding recently. So it is an     important issue to avoid a false negative test in these patients. Siddique et al reported     that the sensitivity of RUT could be increased when the biopsy number increased from 1 to 4.     Other studies demonstrated that additional biopsy from gastric body would increased the     sensitivity of RUT in patients with ulcer bleeding. Therefore, we design this study to see if     increased number of biopsy or different location of biopsy could increase sensitivity of RUT     in patients with gastroduodenal ulcer bleeding.      After receiving explanation and giving consent, these patients with gastric or duodenal ulcer     bleeding diagnosed after endoscopic examination will be enrolled. Those who are unstable,     have received antibiotic or continuous proton pump inhibitor treatment within 4 weeks, or are     contraindicated for endoscopic biopsy will be excluded. We will take 1 piece, 4 pieces of     biopsy samples from prepyloric antrum and 1 piece from gastric body with standard biopsy     forceps from the patients after they agree for RUT test. Then, we put these samples into 3     separate RUT kits respectively. We use 13C-UBT as gold standard for diagnosis of Hp     infection. It is scheduled: (1) if the condition of this patient is not suitable for breath     test just after endoscopic examination, 13C-UBT will be performed within 2 days,(2)     otherwise, it will be performed 1 hour after examination. We plan to enroll 100 patients for     this study. We will apply McNamer's test to examine the difference of RUT sensitivity of     different biopsy number. For the RUT sensitivity from different locations, we use kappa     statistic method to analyze their consistency.   "
152915|NCT01282229|"     The purpose of this study is to compare the Laser Assisted New Attachment Procedure (LANAP     protocol) using the Free-running (FR) Pulsed Neodimium: Yttrium aluminium garnet (Nd:YAG)     laser to Scaling and Root Planing (SRP) alone, Modified Widman Flap (MFF) surgery, and     Coronal Debridement (CD) alone with respect to periodontal clinical attachment level gain.   "
152868|NCT01282840|"     Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the     etiology of OAB is complicated and unclear in many aspects. Bladder wall thickness had been     reported to be strongly associated with OAB, but its use as a screening tool remains     controversial. Besides, few studies reported patterns of sexual dysfunction in female     patients with lower urinary tract symptoms (LUTS). Therefore the aims of our study were to     analyze the bladder wall blood perfusion pattern in female LUTS patients, the association of     between the bladder wall blood perfusion pattern and the efficacy of anti-muscarinic     treatment for female OAB, and the patterns of sexual dysfunction in the female LUTS patients.   "
152869|NCT01282827|"     Non-invasive brain stimulation can increase cortical excitability in the visual system, but     it is not known if this is of clinical value. The investigators now assessed if repetitive,     transcranial alternating current stimulation (rtACS) can improve visual field size in     patients with optic nerve damage. The investigators hypothesized that rtACS would improve     visual functions with the defective visual field sectors of the visual field (primary outcome     measure).   "
152870|NCT01282814|"     The objective of this study was to compare the rate and extent of absorption of venlafaxine     hydrochloride 150 mg capsules (test) versus Effexor® XR (reference) administered as the     content of 1 x 150 mg extended-release capsule mixed with applesauce under fasting     conditions.   "
152872|NCT01282788|"     Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer     from stunting of linear growth by 12 months of age. Stunting presumably results from breast     milk supplementation after 6 months of age with complementary foods (CF) that provide     inadequate protein and micro-nutrients. Although supplementation with selected     micro-nutrients may avoid certain deficiency states, CF with animal source foods may be     necessary to avoid stunting. Meat is not readily available in many Central African countries.     However caterpillars, which are locally available and abundant, are a common staple in adult     diets and may be a suitable substitute for animal source proteins in CF. The investigators     developed a cereal made from dried caterpillars that has a nutrient content that appears to     be ideal for CF and demonstrated maternal and infant acceptability. This study will     investigate the efficacy in prevention of stunting of growth resulting from inadequate     complementary foods.      A sub-study will evaluate the biologic effects of the caterpillar cereal to determine whether     caterpillar cereal prevents iron deficiency anemia, reduces the incidence of     neurodevelopmental impairment or infectious diseases.   "
152873|NCT01282775|"     CDC WAY to Health is a three year, group-randomized weight loss intervention study where     approximately 1020 overweight/obese employees nested within 17 community colleges are     randomly assigned to receive one of three promising, state-of-the-art, theory-linked     interventions: Environment/Usual Care (E); Web-based Weight Loss Program + Environment     (WEB+E) or Web + Environment +Incentives (WEB+E+I). College is the unit of randomization and     intervention; employee is the unit of analysis. Follow-up weigh-in assessments are conducted     at 3, 6, and 12 months.   "
152874|NCT01282762|"     The purpose of this study is to determine the durability of seroprotection of HEPLISAV™ and     Engerix-B® and the number of injections of each vaccine needed to maintain seroprotection in     a cohort of chronic kidney disease (CKD) patients over time.   "
152875|NCT01282749|"     The purpose of the SisterTalk Hartford study was to assess whether a theoretically- and     scientifically-based, culturally acceptable weight loss program could be effectively     translated into a faith-based program and subsequently delivered in the church to help     African-American women lose weight.   "
152876|NCT01282736|"     The proposed study will employ a randomized design to evaluate the efficacy of two     group-based guided self-help treatments: Integrative Response Therapy (IRT) and Cognitive     Behavior Therapy Guided Self-Help, a treatment of known efficacy, in group-format (CBT-GSHg)     in the treatment of Binge Eating Disorder (BED), and explore (1) moderators and mediators of     treatment, (2) the relative cost-effectiveness of the two treatments, and (3) between group     differences on secondary measures (e.g., eating disorder and general psychopathology).   "
152877|NCT01282723|"     This multi-reader multi-case study was designed to evaluate the performance of SureCALL® EMG     Labor Monitor® (SureCALL®)to the predicate Tocodynamometer device (TOCO) using the     performance of an Intrauterine Pressure Catheter device (IUPC) as the gold standard.   "
152878|NCT01282710|"     This measurement study was designed to evaluate the performance of SureCALL® EMG Labor     Monitor® (SureCALL®) to the predicate Tocodynamometer device (TOCO) using the performance of     an Intrauterine Pressure Catheter device (IUPC) as the gold standard.   "
152879|NCT01282697|"     Therapeutic solutions to treat solid tumors that are resistant to conventional treatments are     now limited. Laboratory data in animals (on pediatric tumors such as brain tumors, sarcomas     and neuroblastomas) have shown that the combination of irinotecan (HIF1alpha inhibitor) and     rapamycin (mTOR inhibitor) allowed to block development of blood vessels in the tumor and     could, in some cases, stop its progression. This drug combination has already been tested in     adult patients with refractory tumors and seems to give encouraging results with     stabilization of the tumor. The dose and toxicity of irinotecan and rapamycin are known when     these drugs are administered separately and in a context different from that of refractory     tumors. RAPIRI is a phase I clinical trial whose principal objectives are to determine the     maximum dose at which these two molecules may be administered and to assess the safety of     this new combination of drugs.   "
152880|NCT01282684|"     The purpose of this study is to study the safety and tolerability of a single dose of PLX5622     in healthy, adult human volunteers. This will be the first time PLX5622 has been taken by     humans.   "
152881|NCT01282671|"     Hypothesis: Deep breathing exercises performed during the first two months after cardiac     surgery, will improve pulmonary function and patient-perceived quality of recovery.      Specific aim: To evaluate the effectiveness of breathing exercises performed with a     mechanical device for positive expiratory pressure during the first two months after cardiac     surgery compared to a control group performing no breathing exercises.      Design: A prospective, randomized, controlled two-center study.   "
152884|NCT01282632|"     Atypical neuroleptics may have antidepressant qualities in bipolar depression and in unipolar     depression. Some data support the use of both Risperidone and Olanzapine, but there are no     direct comparisons of their relative efficacy and tolerability in treatment resistant     depression. The current study was designed as a pilot study to examine efficacy and     tolerability of Olanzapine vs. Risperidone add on to a failed serotonin re-uptake inhibitor     (SSRI) in depression.   "
152885|NCT01282619|"     The main purpose of this study is to evaluate the safety and efficacy of Huperzine A     sustained release tablets in patients with mild to moderate Alzheimer's Disease.   "
152886|NCT01282606|"     The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation     patients.   "
152887|NCT01282593|"     Down regulation of CD9 in TEL/AML1-positive ALL is addressed in motility assays to explore     its role in B-ALL pathogenesis and its potential implication in relapses (and prognosis).   "
152896|NCT01282476|"     Panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by     blocking certain enzymes. Panobinostat has shown effects against cancer in laboratory     studies. However, it is not known if it will show the same activity in humans. Panobinostat     has been given to participants with various types of cancers, including DLBCL, in previous     research studies. In this study panobinostat will be given with the the antibody rituximab,     which is FDA approved to be given with chemotherapy in DLBCL.   "
153496|NCT01274637|"     The purpose of this study is to determine if it is feasible to conduct a multi-center     randomized trial to determine whether a blood thinner, low-molecular-weight-heparin (LMWH),     is effective at preventing blood clots, thromboembolism (VTE), in postpartum women at risk.   "
152888|NCT01282580|"     Research studies show that the type of fat in the diet may affect breast cancer risk. Fish     oil and fish contain increased amounts of omega 3 fatty acids which appear to stop or slow     down the growth and development of breast cancer cells in laboratory studies of mice and     breast cancer cells. The use of omega 3 fatty acids to reduce the risk of breast cancer     development in humans has not been adequately studied. Eating fish or taking fish oil may     increase the amount of omega 3 in the breast, which may lower one's risk of breast cancer     development.      Persons in this study with do one of the following: (1) take two capsules daily of omega 3     fatty acid supplements, or (2) eat several servings of canned salmon / tuna per week for a     total of three months. Amounts of omega 3 fatty acids in the body's tissues will be measured     by blood tests and a small sample of breast fat as obtained by a fine needle aspiration.      This study is supported by funding from the National Fisheries Institute, Food Innovation     Center of The Ohio State University, and The Ohio State University Comprehensive Cancer     Center.   "
152889|NCT01282567|"     The Artificial Pancreas Project developed by SUPELEC and the University Hospital of Rennes is     focused on the evaluation of an original control algorithm that computes appropriate     subcutaneous insulin infusion in response to continuous glucose measurements The results     during a 24-hour closed-loop period will be compared with those of the open-loop. The     implementation of this algorithm named Error Dynamics Shaping (EDS) requires as a preliminary     a phase of identification of the parameters of the model (insulin pharmacokinetics and effect     on glucose metabolism) followed by a phase of optimization i.e. a personalized adjustment of     the damping parameters of EDS.      The present study aims to formalize this procedure of identification/optimization of the     parameters of the model and controller EDS. They will be determined in type -1 diabetic     patients using insulin therapy and under conditions free from disturbances such as those     generated by the glucidic meals, i.e. during a period of glucidic fast. Three variables will     determine this procedure: blood glucose, insulin concentration and insulin doses.   "
152890|NCT01282554|"     Sport improves quality of life and health, decreasing cardiovascular risks and increasing     effort tolerance. Chronic renal failure (CRF) induces many clinical and biological     complications leading to less effort tolerance (strength and endurance). Renal failure     patients got also many cardiovascular risks : sedentarily lifestyle, hypertension (HTA),     diabetes, neuropathies, bone disorders, depression and sedentarity due to dialysis sessions.     Moreover, dialysis sessions three times a week induce the spiral of deconditioning. In order     to counteract this, sport should be encourage in this specific hemodialysis population.      The aim of this study is to evaluate electrostimulation program during dialysis sessions for     3 months. Evaluation will be done using the Test of 6-minute walk (6MWT).      Secondary aims will be evaluated:        -  Muscular strength and quadriceps diameter        -  Equilibrium        -  Quality of life.        -  Strength developed during maximal exercise test in a subgroup (patient undergoing          dialysis in Rennes center, about 40% of the total population)        -  Nutritional intakes (quantitative and qualitative evaluation)   "
152891|NCT01282541|"     Epiphora or excessive tearing is a significant disability for many affected patients     diminishing their quality of life. There is a growing consensus that injection of Botulinum     Toxin A (BTX-A) into the lacrimal gland provides relief in patients with hyperlacrimation     secondary to aberrant regeneration of the 7th nerve, and limited evidence that it might help     to reduce normal tear production in patients with epiphora from anatomic or functional     outflow obstructions. BTX-A has been injected both transconjunctivally into the palpebral     lobe of the lacrimal gland and transcutaneously into the orbital lobe. Both delivery routes     have been successful in symptom relief with minimal complications. However, the effectiveness     of transconjunctival versus transcutaneous injections has not been systematically compared.     Also, whether the incidence of side effects is related to the dosage, concentration, or     location of injection is unknown and has also not been systematically studied. The     investigators plan to conduct a randomized clinical trial in patients with functional tearing     comparing the transcutaneous delivery route of BTX-A to the transconjunctival delivery route     (the most common route described in the literature). The investigators will also compare the     side effect profile of each delivery route.   "
152892|NCT01282528|"     To evaluate the predictive value of clinical, functional (HAQ), laboratory and US variables     in relation to disease activity and radiographic outcome in patients with RA who start     treatment with Remicade at 24 weeks.   "
152893|NCT01282515|"     To compare the effect and side effects of photodynamic treatment and traditional topical     steroid treatment in female genital erosive lichen planus   "
152894|NCT01282502|"     This study combines midostaurin (PKC412) with radiation and a standard chemotherapy drug call     5-Fluorouracil (5-FU) for subjects with advanced rectal cancer. Midostaurin is a type of     kinase inhibitor which works by blocking proteins associated with cancer cell growth.     Previous studies also suggest that midostaurin may help increase the effectiveness of     radiation therapy. In this research we are looking for the highest dose of midostaurin that     can be given safely in combination with standard chemoradiation.   "
152916|NCT01282216|"     This research is being done to understand the effects of certain types of bone marrow     transplant (BMT) on the immune system. Your doctors are planning a BMT, using one of your     family members as the bone marrow donor, for your cancer. Part of that BMT involves a     chemotherapy drug, called Cyclophosphamide (Cytoxan), given after the transplant. This     research is being done to understand the effects of Cyclophosphamide on the immune system.   "
152895|NCT01282489|"     A basic requirement for every therapeutic procedure is that there be an objective and     validated method to assess the benefit of the treatment for the patient. Currently, there is     no acceptable procedure to quantify the benefit obtained from visual prostheses.      The goal of the proposed research is to evaluate visual tasks and tests that will be given to     a very large number of volunteers with normal vision who will be using a novel virtual     prosthesis simulator. This device will simulate the realistic visual information that a     visual implant can provide and will be used to measure implants in current clinical trials.   "
152897|NCT01282463|"     This multicenter trial will enroll participants with metastatic transitional cell carcinoma     of the bladder, urethra, ureter, or renal pelvis who have had disease progression on     first-line platinum-based chemotherapy regimens. Participants will be enrolled into 1 of 3     treatment arms: docetaxel; docetaxel and ramucirumab; or docetaxel and IMC-18F1.   "
152898|NCT01282450|"     In recent years, it has become clear, that also in non-small cell lung cancer (NSCLC), a     group of patients with less than 5 distant metastases may experience long-term survival when     treated radically to all macroscopic cancer sites. Thus has mostly been established for     individuals with so-called solitary brain metastases and to a lesser extend in solitary     adrenal gland metastases, but in other metastatic subgroups, the same may be applicable. In a     prospective survey in the region of the Integral Cancercentre (IKL), we could identify on a     yearly base 30 patients with NSCLC who could theoretically be amendable for radical treatment     of all oligo-metastatic locations. We therefore want to perform a prospective study in which     patients with less than 4 oligo-metastatic sites from a primary NSCLC will be treated     radically with the aim to improve long-term survival. As many discussion points remain, even     after thorough discussions with chest physicians, pulmonary surgeons and colleagues from     diagnostic disciplines, we decided to go for a pragmatic approach, implying that all     macroscopic disease sites should be treated radically, being defined as surgery with a R0     resection or in case of an unforeseen R1 resection, followed by radiotherapy, or radiotherapy     to a biological equivalent of at least 60 Gy in 30 daily fractions. In the same patient, one     metastatic site may be treated with surgery and another with radical radiotherapy. Systemic     treatment was not made mandatory, because it was felt that it's role is unclear in patients     with early stage local cancer and with oligo-metastatic disease.   "
152899|NCT01282437|"     For patients with stage III non-small cell lung cancer, which is radically treated, we will     investigate whether prophylactic cranial irradiation (PCI) should become standard of care to     prevent brain metastases.   "
152900|NCT01282424|"     The purpose of this study is to evaluate the efficacy and safety of idelalisib in patients     with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to     rituximab and to alkylating-agent-containing chemotherapy. The primary objective will be to     assess the overall response rate.      Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg     taken twice per day. Treatment with idelalisib can continue in compliant patients as long as     the study is still ongoing and the patients appear to be benefiting from treatment with     acceptable safety.   "
152901|NCT01282411|"     Ozurdex(TM) has recently been FDA approved for use in macular edema secondary to retinal vein     occlusion. It remains unclear how quickly the drug works and for how long as the initial     studies did not have frequent anatomic monitoring. This study will utilize frequent Spectral     domain OCT imaging to better understand the onset of treatment effectiveness and duration of     action on the anatomic thickness of the retina, in addition to distinguishing structural     abnormalities of responders from non-responders.   "
152902|NCT01282398|"     The purpose of this study is to determine whether simvastatin is effective in the prevention     of progression of porta hypertension in compensated cirrhosis patients.   "
152903|NCT01282385|"     In the genesis and maintenance of PH associated with liver cirrhosis are two mechanisms that     act synergistically. The first is an increase in hepatic vascular resistance, due in part to     the disruption of liver structure inherent cirrhosis, and increased hepatic vascular tone is     caused by the contraction of perivascular smooth muscle cells, myofibroblasts and hepatic     stellate cells, which represents about 30% of global intrahepatic resistance and is believed     to be due to the production Defective nitric oxide (NO). The second mechanism, which     maintains and exacerbates HTP, is an increase of splanchnic blood flow caused by increased NO     and other vasodilators at this level      In this regard, we believe that in patients with compensated liver cirrhosis, with portal     pressure gradient> 10 mmHg, both acute responders betablockers test as non-responders, the     association of antifibrotic drugs and / or vasodilators, chronic liver selective May be     beneficial in the control of portal hypertension   "
152904|NCT01282372|"     Treatment with tumor necrosis factor (TNF) inhibitors, especially adalimumab, demonstrated an     improvement in work productivity in participants with rheumatic diseases: rheumatoid     arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Limited data was     available for the effect of adalimumab treatment on sleep in all three diseases (RA, PsA, and     AS) and no data was available for the effect of adalimumab treatment on work productivity in     PsA. This long term Health-Related Quality of Life (HRQL) observational study was conducted     to evaluate the effect of treatment with adalimumab on work productivity and sleep     disturbance in Greek participants with moderate to severe rheumatic diseases (RA, PsA, and     AS).   "
152917|NCT01282203|"     The main objective of this post-marketing observational study is to collect data from the use     of general anesthesia in patients undergoing any surgery to create local recommendations.     These data will be based on the evaluation of volatile induction and maintenance anesthesia     (VIMA) with Sevorane® (sevoflurane) in adult patients requiring general anesthesia for     surgery in terms of quality of anesthesia and its influence on cardiovascular system in     common clinical practice in Kazakhstan.   "
152918|NCT01282190|"     Evaluate the effectiveness of motivational interviewing to improve lipid control and     cardiovascular risk in patients with dyslipidemia.   "
152905|NCT01282359|"     The asthma clinical practice guidelines categorize with the highest evidence level the     effectiveness of educational programs. However, health care professionals not regularly     applied it. This may contribute to inadequate control of the disease. Consequently, their     designs and implementation strategies should be reviewed.      Hypothesis. An asthma educational program based on a limited intervention, managed by     professionals with minimal training in education, could provide a significant decrease in the     morbidity of the disease.      Objective. Determine the effectiveness, in terms of prevention of exacerbations (future risk)     and improved asthma control (current control) of an educational program based on a reduced or     minimal intervention.   "
152906|NCT01282346|"     To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce     intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional     surgical treatments have failed.   "
152920|NCT01282164|"     The purpose of this study is to find out if the Glucagon Stimulation Test (GST) is a reliable     alternative to the Insulin Tolerance Test (ITT) for diagnosis of Growth Hormone Deficiency     (GHD) and adrenal insufficiency. In some patients the accuracy of the GST for evaluation of     adrenal insufficiency is compared to the adrenocorticotropin hormone (ACTH ) stimulation     test.   "
169819|NCT00061113|"     The purpose of this study is to evaluate the impact of treating depression on substance     dependent teens.   "
152907|NCT01282333|"     This phase I clinical trial is studying the side effects and best dose of veliparib and     gemcitabine hydrochloride when given with cisplatin in treating patients with advanced     biliary, pancreatic, urothelial, or non-small cell lung cancer. Veliparib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving more than one drug (combination chemotherapy) may kill more tumor cells. Veliparib may     help cisplatin and gemcitabine hydrochloride work better by making tumor cells more sensitive     to the drugs.   "
152908|NCT01282320|"     More than 60 % of women experience hot-flashes during postmenopausal and 20 % have serious     symptoms. Use of combined estrogen/progesterone therapy reduces hot-flashes effectively. In     2001, results from the randomized controlled WHI-study (Womens Health Initiative) showed     increased risk for breast cancer and hearth-disease among users of combined     estrogen/progesterone therapy. This reduced the use of combined estrogen/progesterone     therapy. Many women seek alternative treatment for hot-flashes. They are often told that     physical activity can reduce intensity and frequency of hot-flashes. The evidence for this     advice is sparse.      The primary hypothesis tested in the WHAT-study will be: Increased physical activity reduce     frequency and intensity of hot-flushes among sedentary postmenopausal women with bothersome     hot-flushes.      The WHAT-study is designed as a pragmatic randomized controlled clinical trial. To answer the     primary hypothesis we will need approximately 500 participants. The logistic in a pragmatic     trial of a complex intervention are complicated and we decided to first run a pilot study     with 50 participants as a feasibility study. The pilot gives us opportunity to gain     experience with possible problems like withdrawals and injuries.   "
152909|NCT01282307|"     Background:      Rehospitalisation and discontinued treatment are common among patients with schizophrenia and     is often associated with lack of insight into the illness. Improving patients' insight has     been attempted through psychoeducation and standard treatment but without any considerable     change. A newly developed method, Guided Self-Determination (GSD), originally developed and     proved effective in difficult diabetes care has been adjusted to patients with schizophrenia.     A qualitative evaluation of GSD has shown a positive influence on patients' insight into the     illness.      Aim and hypotheses: The aim of the study is to evaluate the effects of the method GSD in the     care of patients with schizophrenia compared to treatment as usual. The following hypotheses     will be tested:      The method GSD will improve: Cognitive and clinical insight in patients, various domains of     recovery, patients' self-esteem, psychopathology and social functioning.      Material and method:      The study design is a randomised controlled trial. The participants are diagnosed with     schizophrenia and schizoaffective disorder, receiving treatment in 3 Assertive Outreach Teams     and 3 Psychosis Teams in Region North. Participants complete four self-rating questionnaires,     a demographic data sheet, an interview concerning psychopathology and an assessment of social     functioning at baseline, and after 3, 6, and 12 month. All assessments will be conducted by     the investigator, except for the assessment of social functioning, that will be measures by     community nurses. Intervention with the method GSD will also be conducted by the community     nurses but under supervision from the investigator. Fifty patients are randomly assigned to     immediate receipt of individual training with the method GSD (intervention group) and 50 to a     12-month waiting list for individual training with the method GSD (control group).      Perspectives:      In mental health nursing practice in Denmark there is no tradition for empirical research as     the basis of psychiatric nursing - unverified theories or general empirical consensus of good     clinical practice are often the foundation of psychiatric nursing. If the method GSD proves     effective in the care of patients with schizophrenia, this study contributes to an evidence     based nursing intervention, which is ready for further research on implementation in mental     health nursing practice.   "
152910|NCT01282294|"     This post market clinical follow-up is to confirm the clinical usefulness of the Expert     Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia     fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific     questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse     Events or complications.   "
152911|NCT01282281|"     Background: Most psychotropic medications that are effective in the treatment of Bipolar     Disorder (BD) are associated with endocrine-metabolic changes (EMCs). To date, there is no     long-term study in BD that has examined specifically the association of inflammation with     EMCs in BD. Specific aims: 1) to identify predictors of EMCs among adolescents and adults     with BD who are being started on a medication ; 2) to compare change in EMCs in youth and     adults treated for BD; 3) to measure change in EMCs associated with use of different     medications for BD. Research Design: Participants: 30 adolescents (14-18 years old) with BD     and 30 adults (19-65 years old) with BD. Measures: Blood levels of biomarkers that are     associated with EMCs will be measured.   "
152912|NCT01282268|"     To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the     treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)   "
152913|NCT01282255|"     This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease     activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo     in subjects with active Rheumatoid Arthritis (RA).   "
152914|NCT01282242|"     This study was jointly developed and is jointly led by investigators at Massachusetts General     Hospital and the intramural division of NINDS. We are doing this research study to find out     if Activase ® (also called alteplase or rt-PA) can safely be given to people with an acute     ischemic stroke when their stroke onset was not witnessed making them ineligible for standard     thrombolytic (clot busting) therapy. We also want to find out if rt-PA can help people     recover better from their stroke.      The purpose of this study is to: 1) see if it is safe to give intravenous (IV) rt-PA to     people with unwitnessed stroke but with MRI evidence of early ischemic stroke, 2) see if     rt-PA is effective if given to people who are selected for treatment based on MRI evidence of     an early stroke, and 3) get information about this new MRI diagnostic methods for guiding     stroke treatment.   "
164839|NCT00005415|"     To determine the magnitude of the relationship between physical activity level and subsequent     health care utilization over a seven to ten week period in a general population.   "
152919|NCT01282177|"     The overall objective of this study is to provide ongoing assessment of the safety and     effectiveness of seasonal and pandemic H1N1 vaccines in the prevention of ILI (influenza like     illness), ILI-associated work absenteeism, and laboratory-confirmed influenza in a cohort of     Canadian HCP (Health care providers). Given the uncertainties around the timing of the     provision of seasonal influenza immunization to HCP for the 2009/10 influenza season, this     study will focus on evaluation of safety and effectiveness of pandemic influenza immunization     in Year 1 and evaluation of all recommended influenza vaccines in Years 2 and 3.   "
152921|NCT01282151|"     This study is:        -  A multicenter, prospective, randomized, phase 3 trial.        -  To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a          front line treatment of patients with non-squamous cell lung cancer.        -  276 patients will be recruited.   "
152923|NCT01282125|"     Recent clinical findings of research at Trondheim University Hospital suggest that surgical     correction of the nose septum in addition to volume reduction of the nose cavity may be     beneficial in patients who suffer from both nose obstruction and obstructive sleep apnea     syndrome(data not yet published).      This study aims to compare nose obstruction prevalence in sleep apnea patients and the     general population   "
152924|NCT01282112|"     This is a retrospective chart review study (700 charts from 2002 to 2010)of children from 0     to 18 years of age who have undergone Brainstem Evoked Auditory Response (BEAR)testing using     midazolam and pentobarbital protocol for moderate sedation. The specific aims of this study     are two-fold:        1. to determine the efficacy of intravenous pentobarbital during BEAR testing in the          pediatric population using a standardized protocol; and        2. to evaluate the incidence of adverse events (major and minor), paradoxical reaction and          failed sedation and identify predictors for failure and adverse events if any.   "
152925|NCT01282099|"     While near infrared spectroscopy is an exciting technology, scientific rigor is required in     order to optimize its appropriate use in the clinical arena. This study will explore the     feasibility and clinical applicability of data obtained from the NIRS device. The ability to     noninvasively monitor peripheral perfusion remains an area of intense research. The most     widely used method is pulse oximetry. The international mandate of its use in operating rooms     in the early 1990s after the publication of the Harvard minimum standards for monitoring     speaks to its unquestionable utility. Its pervasive application notwithstanding, pulse     oximetry merely provides a calibrated ratio of arterial and venous hemoglobin saturation.     While this data is valuable, time-tested, and even may hold the promise of accurately     noninvasively trending cardiac output, cellular dysmetabolism -- hallmarks of vulnerable, yet     viable tissue beds -- are beyond the predictive values of currently available devices.   "
152926|NCT01282086|"     The main objective of this post-marketing observational study (PMOS) is to collect data of     using general anesthesia in patients undergoing any surgery to create local recommendations.     These data will be based on the evaluation of volatile induction and maintenance anesthesia     (VIMA) with Sevorane® (sevoflurane) in adult patients requiring general anesthesia for     surgery in terms of quality of anesthesia and its influence on the cardiovascular system in     common clinical practice in Ukraine.   "
152927|NCT01282073|"     Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic     membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The     investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a     reasonable alternative with fewer side effect.   "
152928|NCT01282060|"     The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C     LEVEL) and specific causes of death.   "
152929|NCT01282047|"     Lenakap : This multicenter, non randomized (single arm), open, phase II study aims to     evaluated the efficacy of Lenalidomide in HIV-associated kaposi disease. Patients will be     followed for 48 weeks. Measurement of primary endpoint will be at 24 weeks.   "
152930|NCT01282034|"     INTRODUCTION Marrow stimulation techniques as subchondral drilling or microfractures     represent ones of the most frequently used methods for chondral and osteochodral defects     repair and considered as standard techniques.      MaioRegen® (Fin-Ceramica Faenza S.p.A., Italy) is a bioceramic, multi-layered scaffold, in a     single gradient structure, consisting of deantigenated Type I equine collagen and Magnesium     enriched-Hydroxyapatite, able to mime the entire osteocartilaginous section. MaioRegen® is     able to promote the tissue regeneration in case of severe and large chondral/osteochondral     lesions, otherwise difficult to treat, as previously demonstrated in vitro, in vivo and in a     clinical study.      OBJECTIVES The present study proposes to compare MaioRegen® performances with respect to     reference standard surgical techniques (microfractures and subchondral drilling) for the     treatment of chondral/osteochondral lesions, in order to consolidate MaioRegen®, as     innovative surgical approach.      STUDY DESIGN The clinical trial is multicenter, prospective, randomized, controlled, two-arm,     single-blind and involves eleven European centres and 150 patients. Eligible subjects will be     randomly allocated to one of the two treatment groups: control group, treated with marrow     stimulation techniques, and treatment group, treated with MaioRegen® implant.      Patient defect will be evaluated pre-operatively and each patient enrolled must meet all the     entry criteria for the trial. Before enrolment, each subject should declare his voluntary     participation to the study by informed consent signature.      Arthroscopic control will be carried out immediately before the randomization and thus     surgical treatment, to confirm the characteristics of the lesion to be treated and finalizing     the recruitment.      For each patient 6, 12 and 24 months post-operative follow-up visits will be carried out and     during each follow-up visit the Case Report Form (CRF) will be filled in the specific     section.      Within the CRF, at each follow-up section, commonly used and specific scores will be assigned     for the established end-points (IKDC, KOOS, Tegner Score, VAS, MRI Mocart Scoring System).      Patients selected will be randomized to undergo one of two study groups, as prescribed by the     randomization list.   "
152943|NCT01281865|"     This phase I/II clinical trial is studying the side effects and best dose of everolimus when     given with imatinib mesylate and to see how well they work in treating patients with locally     advanced, locally recurrent or metastatic soft tissue sarcoma. Everolimus and imatinib     mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth.   "
153199|NCT01278498|"     Through this study, the investigators are to demonstrate the superiority of Escitalopram over     placebo for the prevention of poststroke depression in patients with acute stroke      The primary hypothesis of this study is;      This study will prove the superiority of Escitalopram on the prevention of poststroke     depression in patients with acute stroke against placebo   "
152944|NCT01281852|"     This phase I clinical trial studies the side effects and best dose of veliparib when given     together with paclitaxel and cisplatin and to see how well they work in treating patients     with cervical cancer that has spread to other places in the body and usually cannot be cured     or controlled with treatment or that has come back. Drugs used in chemotherapy, such as     paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading.     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving more than one drug (combination chemotherapy) and giving chemotherapy together     with veliparib may kill more tumor cells.   "
152945|NCT01281839|"     The purpose of this study is to investigate the effectiveness and safety of TMC435 compared     with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed     after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and     ribavirin as part of their treatment.   "
153497|NCT01274624|"     This is a Phase 1 dose-escalation study with three dose levels to determine the maximum     tolerated dose of REOLYSIN® combined with FOLFIRI and bevacizumab.   "
172662|NCT00093275|"     The purpose of this study is to determine whether HP184 is effective in the treatment of     chronic spinal cord injury (CSCI).   "
152931|NCT01282021|"     Alloimmunization to blood products in transfused patients is a recognized management     challenge in the clinical setting. In particular the ethnic and racial specificity of RBC     antigens and the limited availability of matched healthy volunteer blood donors have     intensified the dilemma. The presence of low prevalence clinically significant RBC antigens     among minorities account for the higher rate of alloimmunization observed in patients from     this group. This is partly due to the racial and ethnic differences between the blood donor     and recipient populations in the US.      The increasing number of new Ethiopian-American immigrants in the US presenting to the health     care system with blood transfusion requirements makes understanding the unique transfusion     needs of this minority population imperative. Although the majority of African Americans     claim origin to West Africa, Ethiopians, being from East Africa, represent a rapidly growing     population in the United States. Furthermore, identifying genetic similarities and     disparities to their West African counterparts will certainly have clinical implications in     terms of transfusion support and disease modifiers. This additional information would help in     understanding the natural history and transfusion requirements of certain debilitating     diseases, such as Sickle Cell Disease, which are known to occur more commonly in African     Americans. Identifying ethnically and racially similar individuals could assist in recruiting     healthy volunteer donors with similar RBC antigen profiles potentially supplementing the rare     donor pool.      Although extensive archeological and sporadic serologic RBC antigen studies have been     conducted in Ethiopia there are no population wide RBC antigen molecular studies. Our study     population is selected by altitude and migration history. Ethiopia being in close proximity     to Red Sea in the northeast, Indian Ocean in the southeast and the rest of Africa in the     south/west has diverse population.      The study is a population based analysis of genetic variation of blood group antigens in     three distinct and conserved Ethiopian sub-populations. Statistical analysis using Chi-square     tests will be performed for each blood group antigen to detect differences in the     distribution between the three sub-populations. The investigators will travel to Ethiopia to     collect blood samples which will be analyzed in DTM at NIH using the standard serologic     methods and currently available molecular genotyping systems. Samples will also be stored for     future high throughput sequencing analysis and other studies.      The study will be a systematic analysis of the distribution of blood group antigens in     Ethiopian sub-populations. Furthermore, new variants could be detected allowing insight in     correlations of particular genotypes and phenotypes.   "
152932|NCT01282008|"     BACKGROUND:      This document outlines the study design and procedures to be used to evaluate a series of     corrective statements to augment consumer knowledge and beliefs about smoking as related to     past actions of tobacco companies. The statements were ordered by a U.S. Federal Court in     U.S. v. Philip Morris USA, Inc., and are intended to target potential misperceptions     resultant of past marketing and promotion practices undertaken by the tobacco industry.      OBJECTIVES:      The U.S. Department of Justice has asked NCI to take the lead on developing and testing     corrective statements with adult and youth audiences to ensure both message comprehension and     avoidance of unintended consequences of message exposure, such as boomerang effects, smoking     triggers, or knowledge gaps.      The court has identified five areas that the statements shall address:        1. The adverse health effects of smoking;        2. The addictiveness of smoking and nicotine;        3. The lack of any significant health benefit from smoking low tar, light, ultra light,          mild, and natural cigarettes;        4. The tobacco industry s manipulation of cigarette design and composition to ensure          optimum nicotine delivery;        5. The adverse health effects of secondhand smoke.      ELIGIBILITY:      Message testing will be undertaken with the following audiences:        -  Current smokers (with an oversample of low socioeconomic status individuals)        -  General population nonsmokers and former smokers (with an oversample of low          socioeconomic status individuals)        -  Spanish-speaking Hispanics        -  Youth age 14-17      DESIGN:      Both qualitative and quantitative methods (focus groups and post-test comparison group     Web-enabled surveys) will be used to develop and test a range of corrective statements in the     five areas outlined by the court.        -  Focus group participants: 48-64        -  Survey participants: 2500   "
152933|NCT01281995|"     Background:      - Corticosteroids have been used to treat inflammation and immune system diseases for     decades. However, despite their widespread use, there is little information on the specifics     of how corticosteroids affect the immune system in humans. The Center for Human Immunology,     Autoimmunity, and Inflammatory Diseases is interested in studying how the steroid hormone     hydrocortisone affects the immune system in healthy volunteers, and in doing so to understand     how hydrocortisone given at different doses works in treating many immune and inflammatory     conditions.      Objectives:      - To evaluate the effects of hydrocortisone on the immune and inflammatory responses of     healthy volunteers over the short and intermediate term (up to 28 days after administration).      Eligibility:      - Healthy volunteers at least 18 years of age.      Design:        -  Participants will be screened with a full medical history and physical examination, and          blood and urine tests. At this visit, participants will be separated into two groups,          with each group scheduled to receive a different amount of hydrocortisone during the          study visit.        -  One week before the study visit, participants will provide a blood sample for baseline          testing.        -  Participants will be admitted for a 24-hour inpatient stay that will involve frequent          blood draws. Between blood draws, participants will be able to work, watch TV, walk          around, and so on, and will be provided with regular meals.        -  Blood will be drawn 1 hour before the infusion of hydrocortisone. Participants will be          divided into two further sets of groups with different blood draw schedules:        -  Groups 1 (lower dose) and 2 (higher dose) will have blood draws 1, 4, 8, 12, and 24          hours after the hydrocortisone infusion.        -  Groups 3 (lower dose) and 4 (higher dose) will have multiple blood draws over 24 hours,          with timing based on data from the previous groups blood test results.        -  Participants will provide additional blood samples 7 and 28 days after the in-patient          visit.   "
152934|NCT01281982|"     Background:      - The blood-brain barrier helps to protect the central nervous system (brain and spinal cord)     from harmful toxins, but also prevents potentially useful chemotherapy from reaching brain     tumors. The barrier is formed by tight connections between blood vessel cells and molecules     found on the surface of brain blood vessels such as Permeability-glycoprotein (Pgp). Pgp may     influence whether patients with brain tumors known as gliomas respond to chemotherapy and     what side effects they may experience. The compound (11C)N-desmethyl-loperamide ((11C)dLop)     reacts to Pgp molecules, and therefore may be used with positron emission tomography (PET)     imaging to study the blood brain barrier.      Objectives:      - To study the ability of PET imaging with (11C)dLop to evaluate the blood brain barrier in     brain tumor patients.      Eligibility:      - Individuals at least 18 years of age who have a brain tumor with characteristics that may     be imaged with techniques such as magnetic resonance imaging (MRI) andPET.      Design:        -  Participants will be screened with a full physical examination and medical history,          blood and urine tests, and tumor imaging studies (fluorodeoxyglucose PET and MRI scans          with contrast agent).        -  The (11C)dLop scan will take 1 hour to perform. Participants will be asked to return for          blood and urine tests approximately 24 hours after the PET scan.        -  Participants will have followup visits at least every 4 months by repeating a complete          history and physical exam and brain MRI. Participants may have repeat scans with          (11C)dLop at various points in the course of cancer treatment, but will not have these          scans more than twice in a 12-month period.        -  Participants will be followed for as long as possible during treatment to see if imaging          with (11C)dLop correlates with response to the treatments....   "
152935|NCT01281969|"     Background:      - Some children experience a sudden onset of symptoms similar to those found in     obsessive-compulsive disorder that may be caused by the body s reaction to an infection with     streptococcal bacteria, most commonly seen as strep throat or scarlet fever. When the body s     immune system reacts against brain cells following a streptococcal infection, the condition     is known as PANDAS (pediatric autoimmune neuropsychiatric disorders associated with     streptococcal infections). The immune system response can be inactivated by treatment with a     drug known as intravenous immunoglobulin (IVIG). Because there is insufficient research on     IVIG s effects on the immune system of children with PANDAS, including whether IVIG is     helpful in treating obsessive-compulsive symptoms related to PANDAS, researchers are     interested in examining whether IVIG is an appropriate treatment for PANDAS and its     associated symptoms.      Objectives:      - To test the safety and effectiveness of intravenous immunoglobulin for the treatment of     obsessive-compulsive disorder in children with PANDAS (pediatric autoimmune neuropsychiatric     disorder associated with streptococcal infection).      Eligibility:      - Children between 4 and 12 years of age who have obsessive-compulsive disorder (with or     without a tic disorder) with sudden onset of symptoms following Group A streptococcal     bacterial infections.      Design:        -  Participants will be screened by telephone to obtain medical history and other          information, followed by in-person screening at the National Institutes of Health          Clinical Center.        -  Participants will be admitted to the hospital to receive 2 days of infusions of either          IVIG or a placebo. Frequent blood samples, imaging studies, and other tests will be          performed during this visit.        -  Six weeks after the inpatient stay, participants will return for further blood samples          and other tests. Participants who did not receive the study drug, or who received the          drug but did not respond to the initial IVIG infusion, will have the option to receive          IVIG at this time.        -  Followup visits will take place 3 months and 6 months after the first evaluation,          followed by yearly follow-ups for 5 additional years.   "
152982|NCT01281332|"     Hypothesis: A mechanical device when applied to the back of the neck at the onset of a     menopausal hot flash will attenuate the severity and duration of symptoms providing women     with a reassuring non-hormonal intervention to improve quality of life in the menopausal     transition. This pilot study will evaluate the effectiveness of this unit.      The mechanism of action of the device will not be revealed in advance.   "
165068|NCT00005471|"     To evaluate the hypothesis that chronic anxiety and/or anxiety disorders resulted in     hyperkinetic cardiovascular autonomic regulation, often associated with increased coronary     risk.   "
152936|NCT01281956|"     Background:      - The brain chemical serotonin helps nerve cells communicate. Previous research suggests that     serotonin activity may be lower in brain areas where seizures start, and that increasing     activity at the serotonin receptor site on nerve cells may help prevent seizures. Researchers     are interested in determining whether the experimental medication PRX-00023, which increases     the activity of serotonin receptors, can reduce seizure frequency in people whose seizures     are not well-controlled on antiseizure medication. PRX-00023 has not previously been studied     in people with epilepsy and has not previously been given to people taking antiseizure     medication at the same time.      Objectives:      - To evaluate the effectiveness of PRX-00023 in reducing the frequency of epileptic seizures     that start from only one part of the brain.      Eligibility:      - Individuals between 18 and 65 years of age who have frequent epileptic seizures even after     trying at least two different standard anti-seizure medications (either at the same time or     one after the other).      Design:        -  The study requires 9 outpatient visits to the NIH Clinical Center over a 34-week period.          Individuals who choose to participate in additional studies may be an inpatient during          some of these visits.        -  Participants will be screened with a medical history and physical examination, blood and          urine samples, ECG, EEG, neuropsychological studies, imaging studies, including PET and          MRI scans        -  Participants will have a 6-week observation and evaluation period before starting the          study medication. Participants who have at least four seizures during this period will          be eligible for the treatment portion of the study.        -  All participants will receive either PRX-00023 or a placebo pill twice daily for 12          weeks, and will have regular clinic visits with blood samples and imaging studies.        -  After the 12-week period, participants will have a 2- to 3-week washout period without          any study medication.        -  Participants will then have another study medication period, and will receive the          opposite pill (PRX-00023 or placebo) from the one taken in the first treatment phase.          Participants will continue to have regular clinic visits with blood samples, ECG, EEG          and neuropsychologicalstudies.        -  One month after the end of the second study medication phase, participants will have a          followup evaluation with a physical examination, blood tests, ECG, EEG, mood and          neuropsychological tests.      Outcome measures:      The primary outcome measure for drug efficacy will be:      Mean difference in seizure frequency comparing the active and placebo periods.      Secondary outcome measures for efficacy will be:      Proportion of patients with greater than or equal to 50% lower seizure rate on PRX-00023 than     placebo      Hamilton Depression and Anxiety Rating scales      Performance on mood and neuropsychological testing scales   "
152937|NCT01281943|"     This Phase II study will use the MTD from a previous Phase I study at the recommended dose     for the combination regimen from the Phase I trial, Doxil 25mg/m2 IV Q 4 weeks and     temsirolimus 25mg IV Q week.   "
152938|NCT01281930|"     Abscesses or boils are becoming more common every year and are a common reason children     come to the Emergency Department. For the abscess to heal the skin needs to be opened to let     the pus come out. Often doctors put something called packing material or gauze into the     abscess space to help aid in healing. It is not known if the type of packing that is done     is necessary or if a more simple treatment is as good or better. With informed consent we     randomly place a child into one (1) of two (2) groups in this study that will say if the     child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece)     of gauze is placed after the abscess/boil is opened and the fluid is drained. After treatment     in the emergency department the child will be scheduled to follow-up in the Pediatric Acute     Wound Service (PAWS) clinic as all other children with this infection are scheduled. At this     visit the healing of the wound will be checked by the staff in the clinic and will be scored.     With this evaluation of the wound the hypothesis that for a simple superficial (skin)     abscess/boil a gauze wick placement into the abscess/boil is as effective as placement of     traditional gauze packing.   "
152939|NCT01281917|"     The investigators want to find out if the drugs Velcade and temsirolimus given together are     effective in treating cancer. Velcade and temsirolimus are each FDA approved individually for     certain types of cancer (Velcade for multiple myeloma and mantle cell lymphoma, and     temsirolimus for renal cell carcinoma) but are not currently approved in combination for     B-cell non-Hodgkin lymphoma. The investigators are trying to find out if giving these 2 drugs     together will improve the period of time that the patient's cancer is stopped or slowed from     growing and causing symptoms.   "
152940|NCT01281904|"     There are over 2 million breast cancer survivors today. Persistent Cancer-Related fatigue     (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms     experienced by breast cancer (BC) survivors. Rates of significant PCRF in BC survivors range     from 30% to 82% within the first 5-years of diagnosis and there are few treatment options for     PCRF and these treatments require the availability of a trained practitioner, are associated     with significant costs, pose a sizeable burden for the patient, or have unacceptable     side-effects.      Acupressure is a technique derived from acupuncture, a component of Traditional Chinese     Medicine. In acupressure, physical pressure is applied to acupuncture points by the hand,     elbow, or with various devices to treat disease. Pilot studies have demonstrated that     self-administered acupressure can significantly decrease PCRF by as much as 70% in cancer     survivors. Acupressure can also have positive effects on sleep quality in cancer patients and     other chronically ill populations. Self-administered acupressure is a non-toxic and     inexpensive treatment that requires minimal instruction. It also requires little effort and     time on the part of the patient to successfully complete. Thus, acupressure appears to be a     promising treatment for PCRF and associated symptoms.      The investigators are conducting a single-blind, placebo controlled study to examine the     specific effect of two opposing acupressure treatments compared to standard of care. The goal     of this study is to determine the benefit of acupressure on treating persistent fatigue     experience by many patients after completing their cancer treatment. Study patients will be     randomized into one of three groups: two different types of acupressure or a standard of care     arm. For those participants randomized to receive acupressure, the technique will be taught     to them by a study nurse trained by an acupressure specialist. Participants will be asked to     perform the acupressure daily over the next six weeks, during which time they will record     their fatigue and be asked to wear an activity monitor to have their daily activity levels     monitored.   "
152941|NCT01281891|"     Postoperative pain following total hip arthroplasty (THA) (1) is often considered moderate to     severe and can therefore influence the postoperative course of event and result in delayed     postoperative mobilization and prolonged hospitalization. It is therefore necessary to find     the most optimal method for alleviation of pain for these patients. Traditionally, this has     been managed by epidural analgesia, continuous peripheral nerve blocks, parental- or spinal     opioids. Recently, Drs Kerr and Kohan at the Joint Orthopaedic Centre in Sydney, Australia     developed a local infiltration analgesia (LIA) technique. The technique was introduced in     Scandinavia during 2001 and has been shown to be efficacious during knee surgery. The LIA     technique is based on a systemic infiltration of a mixture of a long-acting local anaesthetic     (ropivacaine), a non steroidal anti-inflammatory drug (ketorolac), and epinephrine into the     tissue around the surgical field to achieve satisfactory pain control with little     physiological disturbance. A catheter is left from the skin and into the joint cavity,     allowing repeated injection on the morning after surgery (10). Effective pain relief with     early mobilization and reduced hospital stay has been reported following total knee     arthroplasty and, recently, following unicompartmental knee arthroplasty.      The aim of this study is to assess whether LIA technique is equi-efficacious to intrathecal     morphine, the standard of care in our hospital.   "
152942|NCT01281878|"     In this study the investigators will prospectively analyze the reduction of urinary oxalate     excretion under the treatment with PLP in dosages of 5mg/kg/day up to 20 mg/kg/day and serum     level response relationship with PLP as an i.v. solution used orally in 12 patients with     primary hyperoxaluria type I as an inherited autosomal-recessive-disorder leading to     increased endogenous oxalate production, urolithiasis and end stage renal disease.   "
153000|NCT01281098|"     To evaluate the safety and determine the efficacy of PRP monotherapy or combination therapy     (pegaptanib 0.3 mg plus PRP) in patients with Type I or Type II diabetes mellitus and with     high risk proliferative diabetic retinopathy.   "
152946|NCT01281826|"     The purpose of this study is to        1. Assess bone marrow edema within the VCF by use of a DE CT virtual noncalcium image          compared with MR imaging as standard reference.        2. Evaluate parameters related to the BME of the collapsed vertebral body on DE CT virtual          noncalcium images, such as the morphologic signs, visual qualitative detection, and          quantitative values.   "
152947|NCT01281813|"     The primary objective of this trial is to continue the provision of DRV/rtv to adult patients     who have completed treatment with DRV/rtv in the clinical trials TMC114-C211, TMC114-C214, or     TMC114-TiDP31-C229, sponsored by Tibotec Pharmaceuticals, who continue to benefit from the     use of DRV/rtv, and who live in a country where DRV is not commercially available, is not     reimbursed, or cannot be accessed through another source (eg, access program, government     program).   "
152948|NCT01281800|"     This is a randomised Phase II clinical trial to assess and compare efficacy and safety     profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long     infusion.   "
152949|NCT01281787|"     The aim of this study is to assess whether prophylactic treatment with metoprolol or losartan     is able to reduce the incidence of atrial fibrillation (AF) in patients undergoing thoracic     surgery for lung cancer, showing elevated plasma levels in NT probrain natriuretic peptide     (NT-proBNP), measured in the perioperative period.   "
152950|NCT01281774|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     CSL112 in healthy volunteers after multiple infusions.   "
152951|NCT01281761|"     Based on the results from preclinical study, the investigators suggest that the addition of     simvastatin at a dose of cardiovascular use (40 ~ 80 mg qd daily) may overcome cetuximab     resistance in KRAS mutant colorectal cancer via B-Raf protein degradation and inducing Bim     and Bad. Given the result of a phase II FOLFIRI plus cardiovascular dose of simvastatin (80mg     qd daily) and this study, phase II study of conventional cetuximab treatment with 40 mg     simvastatin is planned in metastatic colorectal cancer patients with KRAS mutation.   "
152952|NCT01281748|"     Clinical practice guidelines for the management of chronic obstructive pulmonary disease     (COPD) recommend treatment with systemic corticosteroids during acute exacerbations. The     results of a Cochrane systematic review show that treatment with systemic corticosteroids     improves lung function over the first 72 hours of an exacerbation of COPD but the effect on     other outcomes, particularly length of hospital stay, is unclear, so further research should     be directed at determining the risk-benefit ratio, particularly those at high risk of     developing adverse drug reactions. In critically ill patients, corticosteroid treatment is a     risk factor of infections, hyperglucemia and critical-illness neuromuscular abnormalities,     and these conditions are associated with an increased morbidity and mortality. The effect of     treatment with systemic corticosteroids in COPD patients with acute exacerbation requiring     mechanical ventilation has not been evaluated investigated so it is unknown if the     corticosteroids could reduce the duration of mechanical ventilation and the length of     intensive care unit (ICU) stay or if, on the contrary, the development of adverse events     could lead to a longer time on mechanical ventilation and ICU stay.      PRIMARY OBJECTIVES: To evaluate the effect of corticosteroids on the duration of mechanical     ventilation, the length of ICU stay, the need for tracheal intubation in patients treated     with non-invasive mechanical ventilation. To evaluate the frequency of adverse events:     secondary infections, pneumonia, arterial hypertension, hyperglucemia, gastrointestinal     bleeding, and critical-illness neuromuscular abnormalities. DESING: Multicenter, prospective,     randomized, double blind, placebo-controlled clinical trial.The treatment group will receive     intravenous methylprednisolone for 10 days and the control group will receive isotonic saline     solution.   "
152953|NCT01281735|"     The purpose of the study is to describe and characterize CML in a large pediatric cohort of     patients.   "
152954|NCT01281722|"     Melanoma is the most aggressive skin cancer, with a propensity to metastasize, and is     resistant to most of the current therapeutic regimens. Incidence rate of melanoma in patients     with MDM (Mal De Maleda, with SLURP-1 mutation) is much higher than normal counterpart.     SLURP-1 (lymphocyte antigen 6/urokinase-type plasminogen activator receptor related     protein-1) is an allosteric agonist to the nicotinic acetylcholine receptor (nAchR) and it     regulates epidermal homeostasis and T-cell function. The preliminary results of comparing     human peripheral blood mononuclear cells (PBMCs) from 4 affected and 15 unaffected members     from the family with MDM revealed that T-cell activation was impaired in PBMCs with the     heterozygous and homozygous SLURP-1 G86R mutation. (2 of affected members developed     melanoma.) Since there is currently no effective treatment for metastatic melanoma,     identifying novel molecular mechanisms may lead to development of new treatments for     metastatic melanomas.      Previous study showed that melanoma stem cells (MSCs) are crucial in melanoma pathogenesis:     1.Melanoma contains ABCB5, CD133 and ABCG2 positive cells had enhanced tumorigenic potential.     2.Higher frequencies of cells capable of initiating melanoma xenografts when using IL2Rγ-/-     NOD SCID mice. These data confirmed the interaction between T cells and MSCs.      In this project, we will investigate the roles of SLURP-1 in melanoma and MSCs. Investigating     and verifying the interaction between T-cells from patients with MDM and melanoma cells to     confirm the SLURP-1 function of tumorigenesis in xenotransplant mice (IL2Rγ-/- NOD SCID)     model. To reveal the role of SLURP-1 silencing in melanoma cell lines by using not only A2058     , A375 and MeWo mwlanima cell lines but also ABCB5+ melanoma cells and ABCB5- melanoma cells     through the tumorigenesis, apoptosis,angiogenesis, proliferation, melanosphere formation     assays.      The aim of this project is to investigate the roles and molecular mechanisms of SLURP-1 in     melanoma carcinogenesis, which may improve the development of novel treatments for melanoma.   "
152955|NCT01281709|"     This questionnaire-based study was focused on understanding primary care physician's wish     toward provision of integrated health care, associated knowledge and attitude, and analysis     of influencing factors affecting their choices.   "
152956|NCT01281696|"     The main purpose of this study is to investigate the efficacy of bevacizumab, etoposide and     cisplatin in treating breast cancer patients with central nervous system metastasis     (including brain parenchymal and leptomeningeal metastasis).   "
152957|NCT01281683|"     Hepatocellular carcinoma (HCC) is a major health problem worldwide. For patients with     intermediate-stage disease, i.e., large or multifocal HCC without vascular invasion or     extrahepatic spread, transarterial chemoembolization (TACE) is recommended as first line     therapy with survival advantages. TACE can be performed repeatedly in patients with recurrent     tumors who have adequate liver function reserves.      Two clinical issues of TACE remain un-resolved. The first issue is the possibility of     TACE-induced liver parenchymal damage, which may influence further treatment options and     outcome of the patients. Conventional ways to evaluate liver functional reserves, including     Child-Pugh score, biochemistry and metabolic tests, and ultrasound elastography, are     relatively non-specific. The second issue is the difficulty in evaluating TACE efficacy,     which cannot be reliably measured by conventional, volumetric response criteria. Both issues     should be resolved to optimize patient care.      Recently dynamic contrast-enhancing magnetic resonance imaging (DCE-MRI) is increasingly used     to analysis perfusion changes of the liver, and can be applied to both liver parenchyma and     tumors. Previous studies have shown clinical applications of perfusion imaging, such as     evaluating the severity of liver fibrosis and cirrhosis, assessing the effectiveness of     anti-angiogenic therapy, and evaluating tumor viability after locoregional therapy. DCE-MRI     can be performed with a hepatobiliary specific contrast agent, Gd-EOB-DTPA (Gadoxetic acid,     Primovist®, Bayer Schering), with dual benefit of dynamic phase and the delayed hepatobiliary     phase imaging. The hepatobiliary phase imaging can provide additional information for hepatic     lesion characterization and the functional status of the hepatocytes. We hypothesize that     imaging parameters of DCE-MRI with Gd-EOB-DTPA could reflect non-tumorous liver parenchymal     changes and can be used to predict and monitor treatment response in patients with HCC after     TACE.      In this prospective cohort study, we will recruit patients referred for TACE with     newly-diagnosed unresectable HCC or tumor recurrence after operation. Patients treated with     radiofrequency ablation (RFA) will be recruited as a control group, since RFA is associated     with minimal damage to the non-tumorous liver parenchyma. Key eligible criteria include     chronic hepatitis B, histological or clinical diagnosis of HCC, tumors that are not amenable     to surgical treatment and referred for TACE or RFA, ECOG performance status 0 or 1,     Child-Pugh class A or B liver function, and measurable tumors (by RECIST 1.1). Eligible     patients will receive the designated treatment (TACE or RFA) according to the current HCC     treatment guidelines. DCE-MRI with Gd-EOB-DTPA will be used to analyze the non-tumorous liver     parenchymal changes and treatment response, and will be performed at baseline, 3 days and 1     month after treatment, and then every 3 months for a maximum of 2 years. The primary endpoint     of this study is progression of liver function reserve. The estimated time for patient     recruitment is about half a year, and 40 patients and 20 patients will be recruited in the     TACE and the RFA treatment group, respectively. The imaging parameters of the non-tumorous     parenchyma and the tumors will be analyzed and correlated with clinical liver function     parameters, and hepatic functional and tumor outcome of the patients.   "
153101|NCT01279772|"     In this study, the investigators propose that the addition of rituximab will lower the risk     of systemic and local relapses in patients with localized PBL. Patients will be treated with     6 cycles of RCHOP-14 or RCHOP-21. The administration of radiotherapy following chemotherapy     is strongly recommended, based on the findings of the retrospective IELSG study, but will be     at the discretion of the treating center.   "
152958|NCT01281670|"     Muscle force, explosive strength and vertical jump height are important parameters     determining the performance of athletes. Traditionally, high intensity resistance training,     explosive strength training and plyometric training are used to improve athletes'     performance. Recently, whole body vibration training is recommended for increasing muscle     force and explosive strength, because vibrating platform could provide high gravitational     acceleration to activate muscle activation and sensory input to spinal reflex. Design:     Prospective and randomized control study. Subjects: Healthy male subjects with regular     training or competition at least 6 hours per week. Methods: H-reflex, V-wave, triceps surae     activation level and rate of force development are measured at pre-training, mid-training     (5th week) and post-training. Subjects will receive 8 weeks, 3 times/week, training programs     including plyometric jumping or static squat on whole body vibration platform. Data analysis:     Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL) and two-way ANOVA     will be used for data analysis.   "
152959|NCT01281657|"     The purpose of this observational study is to collect long-term data on safety and     effectiveness of fingolimod, particularly including clinical disease and patient outcome     related parameters such as relapse and disability, in patients who have participated in prior     trials within the fingolimod clinical development program. Furthermore, this study explores     the incidence of selected safety related outcomes of fingolimod treatment during follow-up     visits within the context of routine medical practice.   "
152960|NCT01281644|"     The investigators hope to establish whether or not the diode laser, a longer-wavelength     laser, is effective in treating keratosis pilaris, and hopefully opening a door into the     discussion and management of this skin condition. The primary outcome of interest is the     difference in the overall blind rater severity scores of the treated versus the untreated     sites. The secondary outcome of interest is the change in the patient's self-rated severity     score of the treated site. To account for potential natural disease progression or     regression, the investigators will also compare patient mean changes to the mean changes in     severity scores of the untreated site.   "
152961|NCT01281631|"     This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in     subjects with ALS.   "
152962|NCT01281618|"     The purpose of this study is to determine the association between acid reflux and cell     changes in Barrett's esophagus.      Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser     degree of stromal activation.      Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive     BE epithelial proliferation.   "
152963|NCT01281605|"     This study compared the effectiveness and safety of two treatment algorithms for insulin     detemir initiation and titration: active titration algorithm (performed by investigator     weekly) versus usual titration algorithm (performed by study subjects weekly) in patients     with type 2 diabetes poorly controlled by OADs.   "
152964|NCT01281592|"     This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or     appropriate target dose if MTD not reached to identify the recommended phase 2 dose of     LOR-253 HCl in patients with advanced or metastatic solid tumours.   "
152965|NCT01281579|"     The purpose of this study is to determine blood and urine concentrations of canagliflozin and     glucose in healthy adult volunteers after administration of single and multiple doses of     canagliflozin.   "
152966|NCT01281566|"     The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding     problems in premature newborn infants.   "
152967|NCT01281553|"     The purpose of this study is to compare the efficacy and tolerability of cisapride with     placebo in infants and children with gastro-oesophageal reflux disease (GORD).   "
152968|NCT01281540|"     The purpose of this study is to assess the effectiveness of cisapride in patients with a     primary diagnosis of chronic gastroparesis (a stomach disorder) of unknown cause.   "
152969|NCT01281527|"     This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of     flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients     previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with     a long duration of action) antipsychotics.   "
152970|NCT01281514|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and pegylated liposomal     doxorubicin hydrochloride (PLD) work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Everolimus may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Giving carboplatin and     PLD together with everolimus may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when     given together with carboplatin and PLD in treating patients with relapsed ovarian     epithelial, fallopian tube, or peritoneal cavity cancer   "
152971|NCT01281501|"     The purpose of this study is to evaluate the immediate synergistic effect on the relief of     severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of     oral antacid and antispasmodic agent (the conventional treatment).   "
152972|NCT01281488|"     RATIONALE: Using fluorescence imaging may determine the extent of kidney tumors and help in     planning surgery.      PURPOSE: This phase I trial is studying the best way to give indocyanine green (ICG)     fluorescence imaging in finding tumors in patients with kidney tumors   "
152973|NCT01281475|"     This study is designed to determine whether levodopa will lead to an improvement in the     development and tremor in children with Angelman syndrome (AS).      It has been suggested that levodopa, a medication that is usually used to treat Parkinson     disease in adults, may help children with AS in their overall development and reduce the     tremor that some of them have.      If levodopa is found to be beneficial for children with AS, this could lead to a new     treatment for AS.      Funding Source - FDA-OOPD   "
152974|NCT01281462|"     This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing     treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus     treatment with IV doripenem.   "
153112|NCT01279629|"     The purpose of this study is:      To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis.      - Population:      50 patients will be selected from both sexes, healthy, between 18 and 65 years with a     clinical diagnosis of chronic plaque psoriasis with PASI <20%, according to the criteria of     inclusion and exclusion.   "
152975|NCT01281436|"     The purpose of this study is to address priority Research Area 3 in PAR-08-270: Health     information technology (HIT) to improve health care decision making through the use of     integrated data and knowledge management. The proposed study will evaluate the use of HIT for     clinician decision support and tailored patient education on the implementation of the     current guidelines for the prevention of obesity-related chronic conditions in health     disparity populations of poor, minority youth who access care through SBHCs. The specific     aims are:        1. To evaluate the effectiveness of web-based training with and without computerized          clinical decision support on provider's process and outcome behaviors related to          implementing the current guidelines for prevention of obesity and related conditions.           a. Process variables include the following: i. Provider knowledge, attitudes, and          barriers to implementing the guidelines. ii. Parent perception of the interpersonal          process of care (i.e., provider communication, collaborative decision making, and          interpersonal style).           iii. Parent perception of provider support for their child's healthy eating and          exercise.           b. Behavior outcomes include the following: i. Provider self-reported behaviors of          identification and assessment of overweight, counseling on nutrition and physical          activity, use of behavioral interventions, referrals, and cultural competency.           ii. Documentation by chart review of body mass index (BMI) percentile for age and sex;          appropriate diagnosis when BMI > 85th percentile; blood pressure (BP) percentile for          age, height, and sex; and ordering appropriate laboratory tests when indicated.        2. To explore the role of HIT in the processes of system change for implementation of the          guidelines for prevention of obesity and related conditions, including the facilitators,          barriers, and impact of the care model on change.   "
152976|NCT01281410|"     The study is a monocentric, controlled randomized trial. Its an interventional method study.     There is a control and an interventional group. The interventional group is receiving a     specific inspiratory muscle training with Respifit (special device for inspiratory muscle     training) during the first 30 days after allogenic stem cell transplantation.      The investigators want to show that the training group gets stronger inspiratory muscles. The     investigators measure the change of PIMAX values and MVV values.   "
152977|NCT01281397|"     Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful     data about platelet function and viscoelastic properties of blood clot in patients undergoing     cardiac surgery.      The purpose of this study is to clarify whether it is possible to predict patients on     excessive risk of perioperative bleeding using whole blood impedance aggregometry and     rotational thromoelastometry.      Antiplatelet therapy is the cornerstone in treatment of patients with coronary artery     disease. Another research goal is to determine the degree of response to antiplatelet therapy     before and after surgery and to investigate whether patients by level of response to     antiplatelet therapy before surgery have a higher risk of perioperative bleeding.   "
152978|NCT01281384|"     Uncovering the underlying cause of heart failure can be quite challenging and doctors often     rely on imaging tests such as echo (heart ultrasound) to provide the answers. Cardiac MRI is     emerging as another promising test because it gives very precise information on heart     function and the amount of scarring in the muscle. Heart failure patients are increasingly     being sent for cardiac MRI but the potential advantage that this test offers over others such     as echo has not been fully explored.      The purpose of this study is to determine if cardiac MRI provides more information on the     cause of heart failure than traditional tests such as echo. In addition, if the information     provided by this test always leads to an overall improvement in a patient's heart condition     over time.      This is a randomized study where subjects referred for clinically indicated heart failure     workup to determine the best clinical management will undergo standard heart failure testing     (including echo) OR standard testing PLUS cardiac MRI.   "
152979|NCT01281371|"     Due to the withdrawal of Thelin (Sitaxentan) in December 2010 all patients with pulmonary     hypertension treated with Sitaxentan need to be switched to an alternative therapy. This     study will observe in which way the change of medication - in the clinical routine, without     exception in charge of the treating physician - affects clinical and laboratory parameters     and patient's quality of life.   "
152980|NCT01281358|"     Infants born very premature have biological risk factors for later developmental coordination     disorder. Parental stereotyping of infants as fragile and other environmental factors, such     as spending long periods laying on their backs, also contribute to motor delay. This study     aims to develop and evaluate a computer-based intervention (Helping Our Premature infants ON     to better motor skills - HOP-ON) for parents of preterm infants. HOP-ON will model evidence     based strategies to develop infants' fine and gross motor skills, and aims to reduce parental     stereotyping. It is hypothesised that infants whose parents receive the HOPON CD-ROM/DVD and     Booklet will have better motor skills at 12 months adjusted age compared to those whose     parents receive a control CD-ROM/DVD and booklet. Parents of infants born at less than 32     weeks gestation (target n = 138) will be recruited prior to discharge from the neonatal unit     and randomised to either HOP-ON or control. The primary outcome is motor score (Bayleys III)     at 12 months adjusted age. Other outcomes are parental confidence and perceptions of infant     capability at 3 months and quality of movement, infant growth, fine and gross motor movement     and parenting stress at 12 months. Data will be analysed blind to study condition and on an     intention to treat basis.   "
152981|NCT01281345|"     Title: A multicenter observational study of candidemia cases among ICU patients in India      Objective: Primary objective:      Determine epidemiological and also clinical parameters of candidemia cases among ICU patients     in India.      Exploratory Objectives:        1. Determine the prevalence of candidemia among ICU patients.        2. Determine the prevalence of candidemia due to C. albicans and each species of          non-albicans Candida species.        3. Determine the demographics and risk factors for candidemia patients and comparison of          relevant variables between the cases with C. albicans and non-albicans Candida species          isolation.        4. Describe physician practice in the management of candidemia cases - clinical and          outcome.        5. Determine the in-vitro antifungal susceptibilities of Candida isolates.      Study description and purpose:      Short description: Observational multicentre study in ICU patients. Study purpose:     Epidemiological determinants of candidemia, management and outcome evaluation.      How the study would help? It would help to evaluate outcomes of current management strategies     and to develop future better management strategies of candidemia cases.      Critical issues & risk: Site & center selection would be important No risk for patients     included in the study as it is only observational study      Study design:      Site selection: A questionnaire will be circulated (annexure I) to all major tertiary care     centers of India. The centers will be selected on the competence of candidemia diagnosis and     availability ICU facilities. Expected number of centers ~ 20.      Study period: October 1, 2010 - March 31, 2012 No of patients/sites: Consecutive all patients     with candidemia detected during ICU stay over the study period will be included in the study     in each site.      Patient selection: Inclusion criteria:        1. Admitted in ICU for > 48 hours (to coincide definitions of nosocomial or ICU-acquired)        2. All age group patients will be included (pediatric & adult)        3. Diagnosed as proven candidemia (isolation of Candida species from blood culture on ≥ 1          occasion during ICU stay)        4. Blood culture positive for Candida spp. , if sample has been drawn within 48 hrs after          discharge from the ICU.      Exclusion criteria:      1. Patient already diagnosed of candidemia before admission in ICU Variables|: types of ICU,     demographic data of patients, underlying illness, risk factors, severity scores, diagnostic     methods, treatment characteristics (Annexure II) and treatment outcomes (Annexure III)      Diagnosis of candidemia: Isolation of Candida species from blood culture (arterial/venous) by     any method (conventional/ lysis-centrifugation/ automated system/ any other method). No     intervention in diagnostic processes at any center. Centers not performing diagnosis of     candidemia will be excluded from the study      Data recording: both manual and online. The form of Annexure II will be filled up within 5     days of diagnosis of candidemia; Annexure III will be filled up within 7 days of discharge     from hospital or 30 days after starting the antifungal therapy or death of the patient (which     over period is early).      Data analysis: appropriate statistical method will be employed for analysis of data.   "
154683|NCT01259167|"     The purpose of this study was to assess whether a training program based on Joba® Core     Trainer is effective in reducing pain and improving physical function and quality of life of     subjects suffering from Chronic Low Back Pain.   "
152983|NCT01281319|"     Subclinical urogenital infections have been implicated in up to 70% of adverse pregnancy     outcome, especially preterm labor and delivery. The most prevalent microorganisms involved in     intrauterine infections are urogenital Mycoplasmas. Diagnosis by culturing or PCR merely     detect the presence of the bacteria, pointing to colonized carriers only. There is no     efficient and reliable diagnostic test to identify those subjects that have developed an     infectious disease and are at risk of developing adverse pregnancy outcome.      In order to identify women at risk for developing pregnancy complications, Promyco     Diagnostics has developed a proprietary, simple and non-invasive serology diagnostic kit for     the detection of urogenital Mycoplasma infection.   "
152984|NCT01281306|"     The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses     of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed     dose of valsartan (320 mg).   "
153531|NCT01274182|"     The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in     patients with severe rheumatoid arthritis.   "
152985|NCT01281293|"     Vagus Nerve Stimulation (VNS) Therapy has been approved marked for the treatment of epilepsy     since 1994. This post-market study is designed to follow the clinical course and outcomes for     patients with refractory seizures treated with adjunctive VNS Therapy. Seizure frequency,     seizure severity, side effects burden, depressive symptoms, global impressions, and health     care utilization will be evaluated. The results of this study will provide data to guide     physicians and their patients in the use of VNS Therapy for patients with refractory seizures     who have failed initial trials of anti-epileptic drug (AED) therapy. The data being collected     is not for the purposes of confirmatory assessment.   "
152986|NCT01281280|"     This is a post-market, open observational long-term effectiveness follow-up study of     participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in     a randomized controlled trial (PuLsE) comparing Best Medical Practice with or without     adjunctive Vagus Nerve Stimulation Therapy.   "
152987|NCT01281267|"     Face transplantation surgery is the transfer of face tissue from a deceased human donor to a     patient with a severe facial deformity. Face transplantation is an innovative reconstructive     procedure that has the potential to significantly improve the lives of patients with severe     facial injuries. The purpose of this study is to develop the best practices for facial     transplantation that will improve the outcomes of future face transplant recipients.   "
152988|NCT01281254|"     To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo     plus PLD as measured by progression-free survival (PFS)      The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo     plus PLD in women with recurrent partially platinum sensitive or resistant epithelial     ovarian, primary peritoneal or fallopian tube cancer.   "
152989|NCT01281241|"     The main objective is to investigate mechanical alternans and MTWA in patients with heart     failure caused by coronary artery disease to demonstrate a possible correlation between these     two phenomena.   "
152990|NCT01281228|"     Glucagon-like peptide 1 (GLP-1) based therapies, such as exenatide, are already successfully     employed in the treatment of Type 2 Diabetes (T2DM). Exenatide improves glycemic control and     is associated with reduced food intake and body weight. The investigators hypothesize that it     affects central reward and satiety circuits and that this may contribute to the weight loss.   "
152991|NCT01281215|"     The purpose of this study is to develop, implement and evaluate an economically viable and     efficient interventions education model for rational drug use, adaptable to different     pathological situations and should be implemented into Brazil Heath Care System.   "
152992|NCT01281202|"     The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent     subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use     of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher     than seen in subjects treated with placebo in addition to counseling.   "
152993|NCT01281189|"     The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe     and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).   "
152994|NCT01281176|"     This randomized pilot clinical trial studies high-dose or low-dose vorinostat in combination     with carboplatin or paclitaxel in treating patients with advanced solid tumors. Vorinostat     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Giving different doses of vorinostat together with     carboplatin or paclitaxel may kill more tumor cells.   "
152995|NCT01281163|"     This phase I trial studies the side effects and the best dose of lapatinib ditosylate and Akt     inhibitor MK2206 in treating women with metastatic breast cancer. Lapatinib ditosylate and     Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.   "
152996|NCT01281150|"     This phase I clinical trial studies the side effects and the best dose of veliparib when     given together with carboplatin and paclitaxel in treating patients with locally advanced or     metastatic solid tumors. Veliparib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by blocking them from dividing. Giving veliparib with carboplatin and paclitaxel may     work better in treating patients with solid tumors.   "
152997|NCT01281137|"     RATIONALE: Studying samples of blood in the laboratory from patients receiving treatment for     cancer may help doctors learn more about changes that may occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This clinical trial is studying changes in estrogen levels and grip strength in     postmenopausal women who have received 4 to 6 years of hormone therapy for breast cancer and     are currently receiving letrozole on clinical trial IBCSG-35-07.   "
152998|NCT01281124|"     This phase II clinical trial is studying how well azacitidine works in treating patients with     previously treated advanced non-small cell lung cancer. Drugs used in chemotherapy, such as     azacitidine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.   "
152999|NCT01281111|"     The purpose of this study is to evaluate the safety, tolerability, and PK of different doses     and dosing regimens of BG00012 administered with and without ASA compared to placebo.   "
153001|NCT01281085|"     Questionnaires are frequently used to evaluate shoulder function in various diseases or after     surgery. However, measurement of shoulder function is presently a controversial issue.     Shoulder movement analysis based on embedded sensors could be a promising alternative to     questionnaires. Some studies already demonstrated the relevance of this approach. It has also     been demonstrated that a simple testing procedure including only two arm movements produces     comparable results to more complicated testing procedures. However, more studies are needed     to extensively establish if this simplified testing procedure provides a trustworthy     evaluation of patient shoulder function and its evolution.      This study is a preliminary study which aims to develop a precise testing procedure which     will be used in a future study aiming to evaluate measurement properties of a simple shoulder     function test based on movement sensors.   "
153002|NCT01281072|"     Open label study to evaluate long term treatment effect of diapep277.   "
153003|NCT01281059|"     The Exalenz clinical investigation is a multicenter, non-randomized, blinded, study of the     ¹³C-Octanaote breath test (OBT). The OBT is a non-invasive test for evaluation of disease     severity in patients with suspected non alcoholic fatty liver disease (NAFLD) The purpose of     the study is to demonstrate that the ¹³C-Octanaote Breath Test (OBT) can be used as an aid,     in conjunction with other clinical information and medical history, for evaluating disease     severity and detecting non alcoholic steatohepatitis(NASH) with a high probability.      Retrospective analysis based on multivariable analysis will determined if and which     demographic, clinical and biochemical or imaging techniques data can assist in addition to     the data derived from OBT in differentiation of NASH, NAFL and possibly normals.   "
153004|NCT01281033|"     To compare rheolytic thrombectomy (RT) with manual thrombus aspiration (MTA) in patients with     acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.      Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the     anatomic substrate of ST-segment elevation myocardial infarction (STEMI). Due to this     substrate, macro- and microembolization during percutaneous coronary intervention (PCI) in     AMI is frequent and may result in obstruction of the microvessel network, and decreased     efficacy of reperfusion and myocardial salvage. Direct stenting without predilation or     postdilation is the most simplistic approach to the problem of embolization, and may decrease     embolization and the incidence of the no-reflow phenomenon. Other approaches to the problem     of microvessel embolization include thrombectomy before stent implantation, and the use of     antiembolic devices (filters and occlusive devices with retrieval of thromboembolic material     after stent implantation). Most concluded studies on removing of thrombus before stenting     used manual aspiration catheters and meta-analyses derived from these studies support the use     of manual thrombus aspiration (MTA) catheters in the setting of primary PCI. MTA is currently     recommended in the setting of primary PCI as a Class II b recommendation; level of evidence     B. Rheolytic thrombectomy (RT) using multiple jets of saline solution and aspiration based on     the Bernoulli effect has been proven to be effective in decreasing major adverse events     during PCI in saphenous vein grafts or native coronary arteries with angiographic evidence of     thrombus, and 2 out of 3 concluded studies have shown a better reperfusion and clinical     outcome in patients randomized to RT as compared to control.   "
153005|NCT01281020|"     A 6-month, parallel, non-interventional trial investigating the level of adherence and the     impact of dosing in open-angle glaucoma patients who receive either unfixed therapy with     latanoprost once in the evening and timolol twice daily, or latanoprost/timolol fixed     combination therapy once in the evening. All patients participating in this observational     study will be monitored for their adherence with the use of Medication Event Monitoring     System (MEMS). At the end of treatment periods treatment satisfaction will be assessed with     selected questions from the Treatment Satisfaction Survey-Intraocular Pressure survey. This     study will monitor objectively, for the first time, adherence and intraocular pressure     control with fixed versus unfixed therapy. Finally it will help us to elucidate the impact of     dosing (once-a-day versus three-times-daily) on the level of adherence in glaucoma.   "
153006|NCT01281007|"     Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by     herpes simplex virus (HSV). There are effective oral prescription antiviral medicines     available to reduce the discomfort of symptoms, such as famciclovir and aciclovir.      This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy     and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with     active recurrent genital herpes.   "
153007|NCT01280994|"     The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas     for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI     contrast will be the investigators focus — 1) imaging of the 129Xe ventilation distribution,     2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC),     and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation. Such     imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting     gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights regarding     the normal resting heterogeneity of pulmonary gas exchange.   "
153008|NCT01280981|"     This was a multicenter, open-label extension study for subjects completing either of 2     pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment     phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g     administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation.     After the last treatment period, a follow-up phone call occurred approximately 30 days (range     25 to 35 days) after the last dose of study drug.   "
153009|NCT01280968|"     The purpose of this study is to find out how vaccine-induced antibodies change the way the     body processes nicotine from cigarettes. These antibodies absorb nicotine and can reduce     nicotine levels in the brain. In this way, the vaccination may help to quit smoking. The     central hypothesis is that anti-nicotine antibodies change kinetics of brain nicotine     accumulation and distribution of nicotine between the brain and other body tissues. This     vaccine is investigational which means that it is still being tested in research studies and     is not approved by the U.S. Food and Drug Administration (FDA) to help people quit smoking.   "
153143|NCT01279226|"     The purpose of this pilot research study is to collect information on the safety and     effectiveness of an experimental device intended to be used to improve the appearance of the     skin by reducing the visibility of wrinkles and by reducing the looseness of skin.   "
153018|NCT01280851|"     Accurate preoperative evaluation of a potential living renal donor's anatomy, vasculature and     function is crucial to ensure optimal outcomes for both kidney donor and recipient in     transplantation.      Currently abdominal ultrasound and spiral CT angiography are used to evaluate renal anatomy     and vascular status, and renal scintigraphy to evaluate renal function. This imaging protocol     exposes this relatively young and healthy population to a high radiation dose and potentially     nephrotoxic contrast agents.      The investigators hypothesize that a single MR-based examination in the preoperative     evaluation of potential kidney donor is a faster, safer, more cost effective and as accurate     as the current multiple imaging work-up protocol.   "
153532|NCT01274169|"     to measure kidney function by measuring blood creatinine and to compare it to the measurment     of GFR by Nanotechnology   "
174448|NCT00117598|"     This is an open-label, randomized trial in relapsed refractory subjects with mantle cell     lymphoma (MCL).   "
153010|NCT01280955|"     This phase I/II clinical trial will test the safety and the efficacy of post transplant     administration of plerixafor in enhancing hematological recovery in humans. Patients who are     appropriate candidates for myeloablative allogeneic stem cell transplantation from an     HLA-matched sibling, matched unrelated donor or umbilical cord blood are eligible for     enrollment. The investigators plan to enroll a total of 50 patients for this study (30     patients with HLA-matched sibling or matched unrelated donor transplant, and 20 patients with     umbilical cord blood transplant). During phase I study, a small number of patients (3-6     patients from each group) will be enrolled to determine the safety of post transplant     administration of plerixafor. Patients will receive plerixafor given at 240 µg/kg     subcutaneously every other day beginning at day +2 after transplant until day +21 or     engraftment. Limiting toxicities are defined as primary or secondary graft failure,     plerixafor-related severe premature ventricular arrhythmia or death. If safety criteria are     met from the investigators phase I study, the investigators will proceed with phase II study     to determine the efficacy of post transplant administration of plerixafor in enhancing     haematological recovery. The experimental aspect of this study is the use of plerixafor and     all other aspects of care will be in line with the standard of care. Both Phase I and Phase     II patients will be combined for efficacy analysis, and data collected from this study will     be compared with the investigators historical control. The results from this study will set     the stage and provide the justification for a larger phase 3 trial.   "
153011|NCT01280942|"     The goal is to develop a two-tiered monitoring system to improve the care of patients at risk     for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH).     The investigators hypothesize that the use of an automated early warning system (EWS) that     identifies patients at risk of clinical deterioration, with notification of nurses on the     GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24     hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse     oximeter to establish feasibility and to develop algorithms for a real-time event detection     system (RDS) in these high-risk patients.   "
153012|NCT01280929|"     The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous     injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of     ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation     alone in the regression of retinal neovascularization in eyes with high-risk proliferative     diabetic retinopathy.   "
153013|NCT01280916|"     The primary purpose of this exploratory and developmental study is to evaluate a mind-body     intervention for relapse prevention for women in addiction treatment. The proposed     intervention, Mindful Awareness in Body-Oriented Therapy (MABT), is a novel mind-body     intervention designed to enhance embodiment and to facilitate mindfulness through the     combination of massage, body awareness exercises and the acquisition of mindfulness skills.     The treatment goals of MABT include reduction of avoidant coping responses, increase of     emotional-regulation, and decrease of trauma symptoms through access to and acceptance (vs.     avoidance) of sensory and emotional experience. These are thought to be important for relapse     prevention given the positive association between stress, negative affect and relapse; and     risk of relapse associated with PTSD symptoms. Mind-body interventions in relapse prevention     are of increased clinical and scientific interest, particularly for the potential to overcome     automatic response patterns that are associated with lapse and relapse in substance use     treatment. This proposal falls within the current NIDA research portfolio focus on the     development of interventions that will help people better cope with stress, negative affect,     and trauma.      Specific Aims:        -  Aim 1: To examine feasibility of recruitment to and retention in MABT as an adjunct to          substance abuse treatment. Specifically, to describe a) study enrollment and barriers to          recruitment, b) sample characteristics, c) response to randomization, d) session          attendance, and e) loss to follow-up.        -  Aim 2: To describe MABT acceptability to study participants and substance abuse          treatment staff.        -  Aim 3: To compare the effect of body-oriented therapy plus treatment-as-usual vs.          treatment-as-usual only on reported days abstinent for overall substance use and primary          drug use among women receiving substance abuse treatment, in order to estimate the          effect size. Secondary analyses will examine for intervention effects on related          outcomes including days abstinence on biochemical screens for substance use, body          connection indicators, avoidant coping, stress reactivity, co-morbid psychological          distress, and physical well-being.   "
153014|NCT01280903|"     The purpose of the Staying Active with Arthritis (STAR) research study is to determine if a     6-month program will improve leg exercise, fitness walking, and clinical outcomes (function,     blood pressure, leg strength, pain, fatigue, and health-related quality of life) in older     adults with osteoarthritis of the knee and high blood pressure.   "
153015|NCT01280890|"     Dementia is a common and devastating disease in the elderly. No cure exist and there is an     increasing need for care. To improve knowledge on how to provide better care for the patients     with dementia in nursing homes, the investigators will carry out a controlled trial using two     forms of education and developmental interventions towards the nursing home care staff: a     structured framework (VIPS) and dementia care mapping (DCM)to develop person-centred care in     a 10 months randomised controlled study. In accordance with the knowledge found in the     literature the investigators hypothesize that both VIPS framework and DCM will be more     effective than a traditional educational program about dementia provided to the staff in     nursing homes. The positive effects will be seen as reduced agitation in patients, less use     of psychotropic drugs and improved quality of life. Using VIPS framework and DCM will also     have a better effect on staffs' well-being than traditional education in dementia. The aim of     the study is to confirm or reject these hypotheses.   "
153016|NCT01280877|"     Aim is to validate that non-invasive brain stimulation can increase cortical excitability in     the visual system. The investigators assess if transcranial alternating current stimulation     (tACS) can improve visual field size in patients with optic nerve damage. Hypothesis: tACS     would improve visual functions within the defective visual field (primary outcome measure).   "
153017|NCT01280864|"     Hypotheses:        1. The bidirectional signaling between the cortex, and the pelvic floor/gut is deranged in          patients with IC and in IBS. Consequently, they will demonstrate hyperexcitability of          the pelvic floor/brain axis as evidenced by shorter latencies and increased amplitudes          for both the afferent anorectal-cortical evoked potentials and efferent          cortically-induced (magnetic) anorectal motor evoked potentials.        2. Unlike patients with IC alone, patients with IBS will also demonstrate anorectal          visceral hypersensitivity and anorectal sensory-motor dysfunction.   "
153043|NCT01280526|"     This study is an open label, multicenter study with two phases:        -  A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without          day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone          (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma.        -  An expansion phase in order to assess the safety and the efficacy of the association of          the recommended dose of Romidepsin associated with CHOP in a population of patients with          T-cell lymphoma.   "
153019|NCT01280838|"     Behavioral interventions designed to reduce risk of HIV and sexually transmitted infections     (STIs) have mostly failed to consider clients of female sex workers (FSWs), who may act as a     bridge to the general population. This study proposes to test a brief, one-hour counseling     intervention with male clients in Tijuana, Mexico, to reduce their rates of unprotected sex     (i.e., sex without a condom) with FSWs as well as their rates of infection with HIV and STIs.     Finding an effective intervention for this population is important given the rising rates of     HIV infection in Tijuana (as documented in earlier studies) and the large numbers of people     crossing the border in both directions, many of them specifically to purchase sex from FSWs     in Tijuana.   "
153020|NCT01280825|"     The purpose of this study is to collect DNA samples from patients undergoing routine care at     the University of Chicago. These samples will be tested for differences in genes that may     suggest greater risk of side effects or chance of increased benefit from certain medications.     The results will be made available to the patient's treating physician and the researchers     will track whether or not this information is used in routine health care.   "
153021|NCT01280812|"     The primary purpose of this study is to assess the efficacy of the mobile phone-based     physical activity intervention on increasing physical activity compared to the control group.   "
153022|NCT01280799|"     This treatment development study seeks to investigate the most effective way to treat an     adolescent's eating disorder and how best to involve the parents or caregivers in this     process.      Typically, parents and their child are seen together in therapy. However, this can sometimes     be difficult for both the parents and the adolescent. Both parents and adolescents have     different concerns and are struggling with different aspects of the eating disorder.     Therefore, the treatment in this study involves the parents in treatment, but the majority of     therapy sessions are conducted with the parent(s) and adolescent separately.      Participants meet with a therapist for 20 sessions over the course of 24 weeks. For the first     16 weeks parents and the adolescent meet individually with the therapist. For the last 8     weeks families meet with the therapist every other week. These last four sessions are     conjoint - that is, adolescents and parents will meet with the therapist together. This is to     help parents and adolescents come together as a family to continue to aid the adolescent in     the treatment of his/her eating disorder.      The investigators hypothesize that adolescents who receive this treatment will demonstrate     improvement in eating disorder symptoms and body-mass index and that caregivers who     participate will demonstrate decreased distress and caregiver burden. Furthermore, the     investigators hypothesize that increases in psychological acceptance will be seen for both     adolescents and caregivers post-treatment, and that treatment will be viewed as both credible     and acceptable to both caregiver and adolescent.   "
153023|NCT01280786|"     This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to     patients with advanced myeloid leukemia.   "
153024|NCT01280773|"     It has been showed that over assist and patient ventilator asynchrony often occur in     mechanical ventilated patients, especially in patients who failed weaning, which are     associated with a prolonged duration of mechanical ventilation. NAVA improves     patient-ventilator synchrony, prevents excessive assist induced diaphragm inactivation. So     the aim of this study was to detect that whether NAVA compared with PSV has the ability to     reduce the duration of weaning in difficult to wean patients.   "
153025|NCT01280760|"     Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory     dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces     the airtightness of the facial mask used to perform non-invasive ventilation and induces air     leaks. The presence of leaks at the patient-mask interface can increase the risk of     patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally     adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is     to record the diaphragmatic electrical activity and to control the ventilator. The     investigators hypothesized driving the ventilator based on a neural signal (diaphragm     electrical activity) would reduce patient-ventilator asynchronies in NIV   "
153026|NCT01280747|"     The investigators hypothesize that fibromyalgia (FM) and painful diabetic peripheral     neuropathy (pDPN) patients with access restrictions on pregabalin will lead to higher     healthcare resource use and cost compared to patients without such restrictions on pregabalin     in a naturalistic setting. The randomization will occur at the physician level and not the     patient level.   "
153027|NCT01280734|"     This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study     investigating the effect on night time awakening body sway of melatonin and zolpidem in     healthy adult subjects aged of 55 to 64 years.   "
153028|NCT01280721|"     ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of     tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).   "
153041|NCT01280552|"     This is a phase 2, multicenter study to determine the safety and efficacy of ICT-107 in     treating a type of brain tumor called Glioblastoma Multiforme (GBM). ICT-107 is an     immunotherapy in which the patient's immune response will be stimulated to kill the tumor     cells. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Some of     the patient's white blood cells (WBC) will be removed and cultured in a laboratory with     purified antigens, similar to those on GBM cells. The patient's own WBC/DC that have been     exposed to the tumor antigens will then be given back to the patient as a vaccine over     several months. The goal is for the ICT-107 vaccine to stimulate the patient's immune     response to kill the remaining GBM tumor cells after surgery and chemotherapy.   "
153042|NCT01280539|"     In this study the researchers want to investigate the effects of long-term transcutaneous     electrical nerve stimulation on the cortical excitability of persons with multiple sclerosis.   "
153145|NCT01279200|"     The purpose of this study is to investigate monitoring methods during ovulation induction     cycles with letrozole and their effect on pregnancy rates. Monitoring ovulation induction     cycles with letrozole can be done with a variety of methods, the two most commonly utilized     are home-based urinary LH kits (or ovulation predictor kits) and office-based midcycle     follicular ultrasound. Letrozole coupled with follicular monitoring by ultrasound may add     extra cost per cycle with no improvement in fecundability (pregnancy rates per cycle).   "
153533|NCT01274156|"     This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on     patients responding to PDE5i therapy in a sham controlled randomized double blind manner.   "
153029|NCT01280708|"     The aim of project DIVAT-URO (Données Informatisées et Validées en Transplantation - Urology)     is to organize a thematic network in urology traced on NetWork DIVAT to supplement the     medical and biological data of DIVAT existing cohort with parameters of surgical     transplantation of kidney and pancreas. These data will concern the transplantation itself     and the events and complications related to surgery occurring throughout the follow-up. The     collection will involve patients in the cohort DIVAT and future patients. This project will     allow us to have the sufficiency of surgical transplantation by increasing the quantity and     quality of information gathered thus avoiding the biases commonly upbraided against the     retrospective studies. Finally, by supplementing it with new parameters, it will strengthen     the medical and scientific interest of the cohort DIVAT and will open new perspectives for     clinical trials in surgery and work in epidemiology.Networking of urologists and the     expansion of the base DIVAT would carry out research in epidemiology and factors that may     play a role in the outcome of renal and pancreatic transplantation. It would also help to     define good practices. The first study from the proposed network DIVAT-Uro is assessing the     impact of vesico-ureteric reflux on the occurrence of urinary tract infections and effects on     survival of the transplant in the recipient adult.   "
153030|NCT01280695|"     The purpose of this study is to assess the safety and tolerability of MSDC-0602 and to     evaluate the reduction in fasting plasma glucose in patients with Type 2 diabetes.   "
153031|NCT01280682|"     Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease     immune-mediated destruction of beta cells and result in preserved beta-cell function in     patients with type 1 diabetes of recent onset.   "
153032|NCT01280669|"     The purpose of this study is to find out about the safety and effectiveness of two different     doses the study drug, sirolimus, administered intravitreally in patients with uveitis. The     potential effectiveness of sirolimus can be utilized to control inflammation in uveitis and     yet avoid the potential complications that are usually associated with the systemic use of     the drug and other immunomodulatory therapies. In this study, the investigators will     administer sirolimus inside the eye (intravitreally) in one of two doses (440mcg/mcL or     880mcg/mcL). Local administration of sirolimus to the eye is not expected to have effects on     the rest of the body. Therefore, it may offer a safer way than the current methods used to     control the inflammation caused by non-infectious uveitis.   "
153033|NCT01280656|"     This retrospective study will assess the sustained virologic response and the safety of two     different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data     will be collected for 24 weeks.   "
153034|NCT01280643|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, oxaliplatin,     capecitabine, and irinotecan hydrochloride, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving more than     one drug (combination chemotherapy) and giving the drugs in different combinations may kill     more tumor cells. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Giving     combination chemotherapy together with bevacizumab or cetuximab may kill more tumor cells.      PURPOSE:To evaluate the use of standard (KRAS) and experimental (thymidine phosphorylase,     ERCC1 and BRAF) tumor testing can aid in selecting chemotherapy regimens   "
153035|NCT01280630|"     TRACE is a Multicentre Retrospective Study planned to gather follow up data for a period of 1     year in order to understand anti-thrombotic management patterns and outcomes of Acute     Coronary Syndrome patients in India.      This retrospective study is designed to provide a rapid and quick analysis of the existing     database of ACS patients. So as to ensure quality check in the study, a pilot study will be     conducted with around 500 patients at 10 centres across India and based on the meaningful     results of the pilot study, full retrospective multi-centric study will be initiated at     various selected centres across India. This study will use available registry data from a     defined time period of Jan 2007-Dec 2009.   "
153036|NCT01280617|"     This is a planned single center prospective randomized study evaluating the safety and     efficacy of low dose thymoglobulin as induction agent in renal transplant recipients.     Inclusion criteria will be adult renal transplant recipients who are not sensitized against     their potential donors. The patients who agree to participate in the study will be randomly     assigned to either thymoglobulin at 1.25mg/kg x 3 doses or 0.75mg/kg x 3 doses. There will be     86 sealed envelopes to perform the randomization process. 43 envelopes with 1.25mg/kg dosing     and the other 43 envelopes with 0.75mg/kg dosing. The investigators will sequentially choose     the sealed envelopes at the time of the patient randomization process. All patients will be     started on our standard immunosupression regimen of prograf/cellcept and a fast steroid     taper. Data will be obtained from every patient for up to one year post-transplant.   "
153037|NCT01280604|"     The primary objective of this randomized trial is to measure the impact of converting     patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who     continue fenofibrate 160mg per day for triglycerides.   "
153038|NCT01280591|"     The objective of the study is to evaluate the efficacy and safety of a single oral dose of     two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that     naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than     either single ingredient alone in subjects with post-surgical dental pain and phase advanced     sleep.   "
153039|NCT01280578|"     A prospective, single arm, multicenter clinical registry evaluating the change in migraine     headaches in migraine with aura patients who undergo patent foramen ovale (PFO) closure with     the Coherex FlatStent™ EF PFO Closure System.   "
153040|NCT01280565|"     Masitinib is a novel TKI that potently inhibits wild type (WT) c-kit and its activated form,     mutated in the juxtamembrane region (JM c-kit) PDGFRs, the intracellular kinase Lyn, and to a     lesser extent fibroblast growth factor receptor 3 (FGFR3).      Pre-clinical data suggest that masitinib is a strong candidate for the treatment of patients     with advanced melanoma carrying a c-kit JM mutation.   "
153044|NCT01280513|"     The purpose of this study is to modulate the protein fermentation and to investigate the     effect on colon toxicity.   "
155119|NCT01253486|"     This study will determine whether the psychological and physical benefits of expressive     writing extend to obese in-patients with Ischemic Heart Disease (IHD)referred to cardiac     rehabilitation   "
153045|NCT01280500|"     The overall goal is to identify best practices for improving health outcomes for patients     with asthma using comparative effectiveness research within an Agency for Healthcare Research     and Quality (AHRQ) Practice-Based Research Network (PBRN). This goal will be achieved by     completing the following aims: (1) Create a centralized database for comparative     effectiveness research on asthma by combining clinical and billing data from one of the     largest healthcare systems in the country (Carolinas Healthcare System) with data from the     school system, Medicaid, and patient and community-level datasets; (2) Deploy a fully     developed integrated approach to asthma management based on the Chronic Care Model; (3)     Develop and implement a shared decision making approach for asthmatic patients from     disadvantaged backgrounds; (4) Implement an electronic data collection system for an existing     CDC funded school-based asthma intervention that will allow program evaluation and link     school nurses with providers; (5) Evaluate and compare the effectiveness of these three     asthma management strategies on: overall healthcare consumption and medical costs; quality of     life, school absenteeism and performance; asthma clinical measures; and medication     utilization; and (6) Disseminate findings across the state via the statewide PBRN and other     network partners. This project has the potential to impact over 30,000 asthma patients across     the Carolinas including many patients from disadvantaged backgrounds.   "
153046|NCT01280487|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and     preliminary efficacy of daily oral doses of ZSTK474, an oral phosphatidylinositol 3-kinase     (PI3K) inhibitor, in subjects with advanced solid malignancies.   "
153047|NCT01280474|"     This study aims at investigating the effects of maternal depressive symptomatology on     pregnancy outcomes and newborn development. How paternal psychopathology is involved in the     association will also be explored.      This is a three-year prospective cohort study. Three versions of questionnaires (the mother,     the father, and the infant) will be developed first. For parents, data on self-reported     symptomatology such as depression, anxiety, and stress will be collected, while for infants,     maternal report on newborn development will be measured. Then, two medical centers and two     regional hospitals will be selected. All pregnant women who undergo a first-trimester     prenatal visit, who plan to carry the baby till term, and whose spouse is also willing to     participate will be invited to join the study. The investigators expect to recruit a total of     194 pairs of depressive mothers and her spouses and 278 pairs of non-depressive mothers and     her spouses in the study.      After the informed consent is obtained, one baseline assessment (i.e., the first trimester)     and four follow-up assessments (i.e., the second trimester, the third trimester, one month     postnatal and six months postnatal) will be implemented. Basically, prenatal investigation     (for both mothers and fathers) will be carried out at the outpatient prenatal visit.     Postnatal investigation (for the mothers, fathers and infants) will be processed at the     pediatric outpatient visit when the infants are schedule for an immunization injection. After     data are collected, descriptive, analytic and longitudinal data analyses will be performed to     investigate the association between parental psychopathology and pregnancy outcomes and     newborn development.      This study will explore the effects of the developmental trajectories of parental     psychopathology on newborn growth during the critical stage of pregnancy. It is hoped that     evidence based data could be obtained, examined, and applied in future     prevention-intervention program to promote parental and newborn health, both physically and     psychologically.   "
153048|NCT01280461|"     This is a phase III, multi-center, open-label, comparative and randomized study in evaluating     the efficacy and safety of cefoperazone/sulbactam versus cefepime for the treatment of     hospital-acquired pneumonia and healthcare-associated pneumonia. The investigator will     determine the total duration of study therapy, as clinically indicated. The minimum duration     of study therapy will be 7 days and the maximum allowable duration of study therapy will be     21 days.   "
153049|NCT01280448|"     Lung cancer is the leading cause of cancer deaths in Taiwan. The carcinogen in the     environment is a key role in the development of lung cancer, and one of its main resource is     tobacco. Activated carcinogens in the organism lead to mutations of crucial oncogenes     resulting in tumor development. Genes such as Cytochrome P-450 family, GST (glutathione     S-transferase) family, UGT (UDP-Glucuronosyltransferase) family, ERCC-1(excision repair     cross-complementing rodent repair deficiency),ERCC-4 and ERCC-5,are encoding antioxidant     enzymes or involving in the DNA repair process and the production of some transcription     factors. In recent years, many studies have shown the correlation between these genes and the     susceptibility of lung cancer. Each gene has a different role in the tumor development     pathway. CYP, UGT, GST, NAT2 (N-acetyltransferase 2) and NQO1(NAD(P)H:quinono oxidoreductase     1) involve in the production of antioxidant enzymes. The antioxidant enzymes can detoxificate     hydrogen peroxide or defense against oxidative stress. However, the genetic polymorphisms may     influence the function of detoxification, which cause the increase in the susceptibility of     lung cancer. P53 and MDM2 genes play important roles in the production of tumor-suppression     proteins and the regulation of transcription factors, which may regulate the growth and the     apoptosis of cell cycle and influence the susceptibility of lug cancer. The polymorphisms in     ERCC genes may cause the damage in the DNA repair process which might also cause increase in     lung cancer susceptibility. The overexpression of epidermal growth factor receptor is highly     correlated with increasing risk of the non-small cell lung cancers. The overexpression may     induce the proliferation of cancer cells and the inhibition of the apatosis. Therefore, in     recent years, EGFR has been widely studied as the new target of the drugs and the     susceptibility of the lung cancer. In addition,the genetic polymorphisms in drug metabolism     channel proteins, like OCT2 (organic cation transporter), ATP7A, ATP7B and ABC (ATP-binding     cassette) transporter may have influence on the metabolism, the efficacy and the toxicity of     the drugs.   "
153050|NCT01280435|"     The trend is changed by a large number of low-cost computers, large-capacity computing power,     and the rapid advent of network bandwidth. From the Internet to the WWW to Web2.0, the     technology in addition brings impact on economic, social, and technological, but also on     medical education about knowledge delivery globally and learning patterns.      Currently, many scholars start to take the affection of social network seriously. In the     medical field, ECGpedia is the typical successful example. There are more than 250,000     members from 188 different countries in the website. On the other hand, the effect of data     computing and transition improve the development of Gigapixel image presentation. For     example, users can zoom in and zoom out on GoogleMap. The research team has being worked on     this kind of search engine on pathology and anatomy slides in past three years. For education     purpose, students can observe slides by using a virtual microscope directly.      This research will target on establishing a Clinical Dermatopathology Online Discourse System     (iSlide). It will combine a virtual microscope platform and a biopsy diagnosis eLearning     System. This survey will be focused on evaluating of this platform. The object is all interns     in dermatopathology department at Wan Fang Hospital this semester. All the new physicians can     learn from experienced experts. Users who have questions can search for help from others via     this website. They can get assistance by thinking procedure learning model -scheme inductive     and pattern recognition. In doing so, clinicians and pathologists can discuss with each other     through this system. It also can improve the education and research development in this     field.   "
153063|NCT01280266|"     The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin     discoloration, is 5-10% in general population. Often conventional measures such as warming up     or minimizing exposure to cold are not enough and many patients require treatment with a     vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil,     a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP.      Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5     inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment     of secondary RP in Korean patients.   "
153051|NCT01280422|"     The doctor's overridden rate for Drug-drug interaction (DDI) alert systems was 85-95% in     foreign and there was more than 90% overridden rate in Taiwan. Why DDI alerts systems which     spent much time and money to establish could not use medicinal information to increase drug     safety? One of the reasons which induced to override was that health care thought there were     too much DDI alerts and high false alerts.      The difference between DDI alert systems from pharmacists to confirm drug-drug interaction     was that pharmacists not only confirmed ordering drug at the same time but also checked the     other drug information such as frequency, rote and refill etc. Therefore, DDI alert systems     which were established by drug code alone would induce a lot of false alerts.      In order to study how much false alert rate in drug-drug interactions, this research selected     most common drug-drug interaction which was antacids and antibiotics. Antacids were most     self-payment so this research needed to analyze ROCDR (Establishing a Multi-Center,     Longitudinal, Research-Oriented Clinical Data Repository for Clinical Research). The aim was     to study how many drug-drug interactions and false alerts from antacids and antibiotics and     analyze the difference in different department. Finally, proposing advice and assessment for     building drug-drug interaction alerts system to strength drug information system and increase     drug safety.   "
153052|NCT01280409|"     The purpose of this study is to determine whether the study drug metformin is helpful in     reducing weight after pregnancy in women with gestational diabetes. This pilot study will     provide information on how well women are able to take metformin postpartum, whether     metformin increases weight loss, and whether there are any increased risks of side effects to     you as a new mother.   "
153053|NCT01280396|"     Second-generation antipsychotics (SGAs), including clozapine, are commonly used nowadays as     treatment for psychosis. There are increasing concerns about their related metabolic     side-effects over weight gain, risks to cause glucose intolerance and hyperlipidemia, and a     specific condition known as metabolic syndrome. All these side-effects might be associated     with the increased risk of cardiovascular diseases and diabetes mellitus.      This study is to analyze the simple physical measurements (weight and height) and venous     blood tests (for fasting blood glucose and lipid) results collected routinely since 2008     (recommended by the local hospital authority as a territory-wide SGAs Monitoring Program)     from those outpatients receiving SGAs (amisulpride, aripiprazole, olanzapine, paliperidone,     quetiapine, risperidone and ziprasidone) and/or clozapine, at a local psychiatric outpatient     clinic in Hong Kong. The investigators hypothesized that there should be differential risks     on metabolic side-effects amongst these SGAs.   "
153054|NCT01280383|"     Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA     delivers assistance to spontaneous breathing based on the detection of the electrical     activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on     respiratory muscle unloading critically ill patients.   "
153055|NCT01280370|"     Nowadays incisional hernia are primarily repaired using prosthetic meshes. In Switzerland     such meshes are mainly implanted via open or laparoscopic approach. The differential impact     of these two types of surgical technique on recurrence rate will be investigated with this     study.      With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia     repair will be investigated prospectively. Hernia recurrence is the main outcome measure.      Hypothesis:      Laparoscopic incisional hernia repair is associated with a lower recurrence rate compared to     open incisional hernia repair.   "
153056|NCT01280357|"     Clinical Investigation Protocol for a study designed to determine the equivalence of the     Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC)     monitoring during labor. The study will be carried out on subjects in the first and second     stages of labor.   "
153057|NCT01280344|"     Post-operative administration of ipamorelin is expected to reduce time to recovery of     Gastrointestinal (GI) function in patients who have undergone partial small and/or large     bowel resection.   "
153058|NCT01280331|"     This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12     mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given     q6hr for the management of acute moderate to severe postoperative pain for 48 hours following     bunionectomy surgery.   "
153059|NCT01280318|"     The obvious hypothesis is that the application of peri-operative targeted biological agents     may counteract the tumor growth effect of these circulating factors and improve patient     outcome   "
153060|NCT01280305|"     The objective of the study is to evaluate the efficacy of raloxifene compared to placebo, as     add-on to anti-psychotics in the treatment of post menopausal patients with schizophrenia.   "
153061|NCT01280292|"     Medical management of central hypothyroidism is controversial due to lack of reference for     evaluation of pituitary negative feedback. Therefore, titration of medical treatment is based     on T4 levels, measured with variable laboratory methods. Patients who have central     hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which     they need replacement therapy such as steroids, testosterone and growth hormone. This     combined hormone deficiency makes clinical and laboratory evaluation challenging among these     patients. Symptomatically, central hypothyroidism is relatively mild and lack non-specific     and it might be overlooked due to other hormonal deficiencies. Replacement therapy for     central hypothyroidism is titrated by arbitrary target free T4 levels of above 50th     percentile of normal. The goal of our study is to compare the standard results from well     known measure methods to a new method for measuring Ft4 using Liquid chromatography - tandem     mass spectrometry.   "
153062|NCT01280279|"     Few studies have reported the efficacy of repetitive education for behavioral modification as     the first-line therapy for patients with nocturnal polyuria (NPU). The aim of this study is     to investigate the efficacy of repetitive education for behavioral modification as the     first-line therapy in the patients with NPU and to show whether a single education for     behavioral modification is sufficient for the patients.   "
153085|NCT01279980|"     The purpose of this study is to find out whether the use of Painbuster® (a local anaesthetic     wound catheter) can be used instead of epidurals for patients having bowel surgery in an     enhanced recovery programme. The investigators want to find out whether or not using this     device means people need to stay in hospital for less time after surgery.   "
153086|NCT01279967|"     To examine whether the arginine depleting drug, ADI-PEG 20, might be effective as a targeted     therapy in patients with ASS-negative malignant pleural mesothelioma.   "
153064|NCT01280253|"     The objective of the study is to identify biochemical predictors of morbidity and mortality     in patients suffering from hip fracture. For this purpose blood samples are collected     prehospitally or in the emergency department in patients with a suspected hip fracture.     During the hospital stay medical history, anesthesiological management recorded. In addition,     american society of anesthesiology physiological score (ASA), revised cardiac risk index     (RCRI), and POSSUM score is calculated. Morbidity and mortality is recorded  in house,     after 30 days, after 4 months and after 1 year. Biochemical predictors of outcome will be     evaluated with logistic regression analysis. Biochemical predictors include pro-brain     natriuretic peptide, lactate, pro-calcitonin, adrenomedullin, copeptin, cystatin c. The     predictive value of the potential markers will be compared to that of ASA, RCRI and POSSUM.   "
153065|NCT01280240|"     The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000     (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced     anemia.   "
153066|NCT01280227|"     Children with Cancer or congenital heart disease (CHD) experience complex, physical,     psychosocial and behavioural symptoms and problems due to the illness, treatment, and medical     procedures. To help children cope with their problems and prevent psychological distress, the     investigators developed SiSom, a support system to help children with cancer or CHD report     their symptoms and problems in an age-adjusted manner on a touch-pad, portable computer.      This quasi-experimental study with 202 children age 7-12 with CHD or cancer will test the     following hypotheses: When children use SiSom to report their symptoms and problems, and this     information is provided to their clinicians in their outpatient consultations:        -  Children and parents will experience less anxiety.        -  Children and parents will be more satisfied with the outpatient visit.        -  There will be greater congruence between children's reported symptoms and problems and          those addressed by their clinicians as evidenced in documented patient care.      To better understand the mechanisms by which these effects may occur, the investigators will     also explore:        -  Differences between control and experimental groups in patient-provider communication in          terms of instrumental and affective behaviour, participation, initiative and person          addressed;        -  The relationships among outcomes of patient-provider communication, congruence between          patients' reported symptoms and those addressed by their clinicians and children's and          parents' anxiety and satisfaction; and how these relationships differ between treatment          and control conditions.      Finally, the investigators will investigate time requirements, ease of use and usefulness of     SiSom by children and clinicians.      For analyses the investigators will use inferential statistics and qualitative analyses of     the video-taped consultation sessions. This study will contribute to improving     patient-centred care for a particularly vulnerable population, and to a better understanding     of the triadic communication and interactions among child-parent and clinician.   "
153067|NCT01280214|"     Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to     systemic Steroid therapy for patients with active thyroid orbitopathy.   "
153068|NCT01280201|"     The incidence of new diagnosed patients with NET of the digestive tract including carcinoid     and pancreatic islet cells tumors ranges from 2 to 10 per 100,000 in the western Countries     (Kulke M, Mayer R. N Engl J Med 340:858-868, 1999). Despite of the low incidence, the     prevalence of these tumors is high because of their relatively long survival estimated in 35%     at 5 years for those patients with well or moderate differentiated tumors (Yao JC, et al. J     Clin Oncol. 2008;26:3063-3072). In fact, digestive NETs are the second most prevalent tumors     derived from the digestive tract after colorectal carcinoma.      NETs are characterized by abundant vasculature, moreover VEGFR and VEGFR are overexpressed in     60-84% of the carcinoids and pancreatic islet cells NETs (Zhang et al. Cancer     2007;109:1478-1486). Other pro-angiogenic factors like the platelet derived growth factor     (PDGFR) have been also involved in NET progression and development (Chaudhry A, et al.Cancer     Res 1992;52:1006-12).      Pazopanib is an oral tyrosine kinase inhibitor of the VEGFR, PDGFR and KIT with a dual     activity both as an antiangiogenic and also and anti-tumoral agent (Kumar et al. Mol Cancer     Ther2007;6:2012-2021, Hurwitz et al. Clin Cancer Res 2009;15:4220-4227). Pazopanib seems to     have a better toxicity profile versus the other antiangiogenic tyrosine kinase inhibitors and     has already shown activity in several tumor types like renal cell carcinoma (Sternberg et al.     J Clin Oncol 2009;27:abst. 5021), soft tissue sarcomas (Sleijfer et al. J Clin Oncol     2009;27:3126-32), hepatocellular carcinoma (Yau et al. J Clin Oncol 2009;27:abst. 3561),     colorectal cancer (Brady et al. J Clin Oncol 2009;27:abst.4133), and thyroid cancers (Bible     et al. J Clin Oncol 2009;27:abst. 3521).      The Spanish Group for Research in Neuroendocrine Tumors (GETNE) group is an active Member     inside of the GENET group and has a large tradition in clinical trials in NETs. The     investigators hypothesize that pazopanib may have at least as good activity and better safety     profile than other VEGFR inhibitors in progressive advanced or metastatic NET tumors derived     from the digestive tract.   "
153069|NCT01280188|"     This is an open-label dose-titration study in Japanese Central Diabetes Insipidus (CDI)     patients designed to demonstrate the efficacy and safety of orally-disintegrating tablet of     desmopressin.   "
153070|NCT01280175|"     The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite     beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol     100/6 µg pMDI combination (CHF1535) using the standard actuator and charcoal block technique     or using a Spacer (AeroChamber Plus, Trudell) in comparison with inhalation using the     standard actuator   "
153071|NCT01280162|"     An observational cohort and malaria treatment study in Cambodia.   "
153072|NCT01280149|"     The purpose of this study is to determine whether a neuropeptide, substance P, when injected     along with an allergen, such as ragweed, can reduce allergic reactivity.   "
153073|NCT01280136|"     The purpose of this study is to evaluate the effectiveness of a web-based HIV, sexually     transmitted infection (STI), and pregnancy prevention curriculum as a stand alone     intervention for 8th grade students in a large urban school district. This web-based     curriculum will be adapted from the computer-based component of an existing successful     prevention program, It's Your Game…Keep it Real, (IYG) but will be enhanced to include     critical elements from the IYG classroom component. The primary hypothesis to be tested is:     (1) students who receive the web-based curriculum will delay sexual activity relative to     those who receive standard care. The major dependent variable is the proportion of students     initiating sexual activity (vaginal, oral, or anal sex). Secondary hypotheses will examine     the effect of the web-based curriculum on specific types of sex (e.g., vaginal, oral, anal)     and psychosocial variables such as students' intentions, knowledge, self-efficacy, attitudes,     and perceived norms related to sexual risk-taking behavior. Secondary hypotheses will also     examine the effect of the intervention on the proportion of students who are sexually active,     number of times students engage in unprotected sexual intercourse, and students' number of     sexual partners.   "
153074|NCT01280123|"     This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of     oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and     futility.      Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8     weeks but no more than 8 months, will be randomized to one of two dosages of oral     pioglitazone (15 mg and 45 mg) or matching placebo.      The study will measure disease progression by the change in total Unified Parkinson's Disease     Rating Scale (UPDRS) score between the baseline visit and 44 weeks.   "
153087|NCT01279954|"     The purpose of this study is to assess the safety and efficacy of abatacept in the treatment     of uveitis.   "
154913|NCT01256164|"     The purpose of this study was to characterize the safety and hemostatic activity of topical     Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical     techniques was ineffective and/or impractical.   "
153075|NCT01280110|"     BAK is one of the most frequent preservatives in eye drops. BAK is a quaternary ammonium salt     with surfactant qualities. It can be bacteriostatic or bactericidal depending on the     concentrations used. It has been shown to be effective against most bacteria with a few     exceptions, such as Pseudomonas aeruginosa, or picornaviruses. It as been widely used in     eyedrops, nose sprays, hand and face washes, mouthwashes, spermicidal creams, and in various     other cleaners, sanitizers, and disinfectants. BAK gained popularity when it was first     introduced because it also enhances corneal penetration of some drugs by causing epithelial     separation.      It is present in several ophthalmic formulations, including most of the antiglaucoma     medications. If used chronically, BAK has been found to cause ocular surface changes, such as     dry eye and punctuate keratitis. BAK has also been suggested to promote a break in the blood     aqueous barrier, which may lead to undesirable consequences, such as uveitis and cystoid     macular edema. However, this information is controversial. The purpose of this study is to     evaluate the consequences of BAK on the blood-retinal and blood-aqueous barriers of     pseudophakic patients receiving BAK-preserved lubricating drops.   "
153076|NCT01280097|"     The investigators will perform a prospective, cohort study of 100 older intensive care unit     (ICU) patients, to investigate the association between sleep disruption and ICU delirium.   "
153077|NCT01280084|"     This study aims to measure movements in babies after they are born using an actigraph, a     wristwatch-sized device worn on the ankle, which works similarly to the device used by     runners to count the number of steps they have taken. We aim to compare the movements of     babies whose mothers have received different types of pain relief in labour.   "
153078|NCT01280071|"     Veno-arteriolar and veno- arteriolar-myogenic reflexes (VAR and VMR, respectively) are of the     most important contributors to local vasoregulation.      In a recent research we showed that VAR is affected in the affected lower limbs of CRPS     (chronic regional pain syndrome) patients. {Dayan, 2008 1 /id} That is, local venous     congestion (40 mmHg) results in a decreased blood flow in the affected, sick limb compared     with its contralateral. The myogenic reflex, however, that is induced by lowering the leg 40     cm below heart level, which causes both venous and arteriolar congestion, was intact in the     sick leg. We concluded that the pathophysiology of CRPS might involve a defect in the neural     reflex between venous and arteriolar vessels. Arteriolar smooth muscle action, on the other     hand, is intact and might compensate for the overwhelmed VAR.      Trying to explain the fact that VAR, but not VMR, was different between the affected and     unaffected limbs, we raise the hypothesis that since VMR is a local vasoregulatory reflex     composed of two components: the venous and myogenic, opposed to the VAR, the myogenoic     component of the reflex might compensate for the inappropriate VAR. Many mechanisms that     might affect vascular muscles may occur, one of them is related to adenosine.      Adenosine is considered a retaliatory autacoid, whose main function is to protect tissues     against ischemia. It is a very potent vasodilator. Adenosine is also considered an important     mediator of ischemic preconditioning, a phenomenon by which an initial brief period of     ischemia protects the tissue from the damage produced by a subsequent more intense ischemic     episode.      Adenosine has a pivotal role in local vasoregulation. In many researches it was shown that     adenosine contributes to exercise hyperaemia in skeletal muscle. The 'adenosine hypothesis'     states that blood flow is regulated by interstitial adenosine, released from cardiac or     skeletal muscle fibers when there is a mismatch between O2 supply and O2 demand. When there     is insufficient O2 to regenerate ATP, ADP and AMP accumulate leading to adenosine generation.     By causing vasodilatation, adenosine helps to restore the O2 delivery, reversing the mismatch     and allowing ATP to be regenerated.      Adenosine is a naturally occurring ligand of 4 subtypes of G-protein-coupled cell membrane     receptors (A1, A2A, A2B, and A3) involved in cellular signaling. Dipyridamole produces     coronary hyperemia by indirectly activating adenosine A2A receptors by inhibiting tissue     uptake of adenosine and thereby increasing levels of endogenous adenosine.      Taking all these considerations into account we hypothesize that local vascular reflexes like     VAR, and eventually VMR are mediated by adenosine. That is, adenosine produced at a constant     rate in vascular bed contributing to constant blood flow under a wide range of local     circumstances. A local increase in venous blood flow (as in lower limbs veins during     prolonged standing) causes adenosine wash out, which leads to local arterial     vasoconstriction to reduce blood flow to the limb, which is, in fact, the purpose of VAR. if     our hypothesis turns to be true, then when we will see exaggeration of the reflexes with     adenosine blockade and vice versa, a decrease its abolishment with adenosine reuptake     inhibition.   "
153079|NCT01280058|"     This phase II trial studies how well carboplatin and paclitaxel with or without viral therapy     works in treating patients with pancreatic cancer that has come back or has spread to other     places in the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Viral therapy may be able to kill     tumor cells without damaging normal cells. It is not yet known whether carboplatin and     paclitaxel are more effective with or without viral therapy in treating pancreatic cancer.   "
153080|NCT01280045|"     The investigators aimed to assess if use of aromatase inhibitors could decrease volume of     uterine leiomyoma and cause same percentage of adverse effects during its use compared to     GnRH analogs.   "
153081|NCT01280032|"     Vertebral column is the most prevalent location of bone metastases. Besides axial pain,     vertebral metastases cause pathological fracture and neurological dysfunction by spinal cord     compression. Although the median overall survival of patients with bone metastases is only     7-9 month, half of them live longer and will require palliative treatment for their symptoms.      Treatment options are radiotherapy and /or surgical treatment such as laminectomy,     vertebroplasty or kyphoplasty. Various studies have shown the superiority of postoperative     external beam radiotherapy after kyphoplasty in spinal metastases compared to surgery or     radiotherapy alone. Nevertheless postoperative radiation schedules last 2-4 weeks. Moreover     many patients present visceral and bone metastases simultaneously and require urgent systemic     therapy. However, due to potentiated toxicity, concurrent therapy with full dose chemotherapy     and radiotherapy is rarely possible.      The investigators have therefore established a novel method for intraoperative radiotherapy     (IORT) during kyphoplasty which enables immediate stability, sterilization of the metastasis     and immediate initiation of chemotherapy.      The kyphoplasty itself is performed according to the standard procedure with some minor     modifications. In short under general anaesthesia, a bipedicular approach into the affected     vertebra is chosen with insertion of specially designed metallic sleeves to guide the     electron drift tube of the miniature X-ray generator (INTRABEAM®). To perform the IORT during     a kyphoplasty with this device a new applicator was designed. This sterile applicator     consists of a plastic head, which is needed to attach it to the X-ray source and a stainless     steel tube. This tube protects the probe from bending. Under fluoroscopic guidance the     applicator including the drift tube is guided through the metallic sleeves in the vertebral     body. A dose of 8 Gy in 5 mm distance is delivered. After IORT the INTRABEAM system is     removed. The kyphoplasty balloon is inflated and PMMA-cement is injected. Afterwards the     sleeves are removed and the wound is closed as usual.      Aim of this study is the definition of the maximum tolerable dose (MTD) for IORT during a     kyphoplasty using specific MTD-criteria and evaluating the effectiveness of this combined     treatment procedure. To determine the MTD 3 levels with increasing doses are planned:      8 Gy in 5 mm distance, 8 Gy in 8 mm distance and 8 Gy in 10 mm distance.   "
153082|NCT01280019|"     In ventilated patients with acute respiratory failure endotracheal suctioning may lead to     alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC)     measurements. Regional distribution of ventilation can be followed at bedside using     electrical impedance tomography. The investigators hypothesize that a FRC guided recruitment     strategy, aimed at restoring a baseline FRC value after open endotracheal suctioning,     improves oxygenation and regional distribution of ventilation. In addition the investigators     research the impact of such a strategy on the inflammatory response to mechanical     ventilation.   "
153083|NCT01280006|"     The study has been designed to assess the effect of cyclooxygenase inhibition on blood     pressure, cerebral blood flow, ventilation and renal hemodynamics following chronic     intermittent hypoxia exposure.   "
153084|NCT01279993|"     Purpose: To detect orthoptic changes in patients undergoing photorefractive keratectomy     (PRK). Method: This interventional case series was performed on 297 eyes of 150 patients who     were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations     were performed before and 3 months after PRK. Results: Before PRK, two (1.3%) patients had     esotropia that remained unchanged postoperatively. However, 3 (2%) patients had distance     exotropia preoperatively which improved after PRK. Of 12 cases (8%) with preoperative     exotropia at near, 3 (2%) cases became orthophoric. Six patients (4%) developed postoperative     near exotropia. A significant reduction in means of convergence and divergence amplitudes     (P<0.001) and a meaningful increase in mean of near point of convergence (NPC) (P<0.006) were     noticed after PRK. A reduction of ≥10 PD in convergence amplitude and ≥5 PD in divergence     amplitude were detected in 10 and 5 patients, respectively. Four patients had an preoperative     NPC>10 cm which was not changed by the surgery. Out of 9 (6%) patients with baseline     stereopsis >60 seconds of arc, 2 (1.33%) cases showed an improvement in stereopsis following     PRK. None of the patients complained of postoperative diplopia. Conclusion: Eye deviation in     patients undergoing PRK may improve or remain unchanged after operation and postoperative     deviations can develop following this surgery. Diminishing of fusional amplitude and     increasing of NPC as well as improving of stereopsis may also happen after PRK. Therefore, a     preoperative orthoptic examination in patients with any concerning histories and/or motility     issues on routine exam is recommended before performing PRK.   "
153099|NCT01279798|"     This is an expanded access protocol designed to make Lucanix® available to subjects with     advanced non-small cell lung cancer (NSCLC) who are not eligible for the Phase III Protocol,     NR001-03. A total of 45 patients will be enrolled into the study.   "
153088|NCT01279941|"     Researchers from Oregon Health & Science University have developed a science-based,     team-centered, scripted peer-taught program for fire fighters improving diet and exercise     behavior while reducing injury rates and costs. Those investigators are partnering with local     law enforcement agencies in Oregon and SW Washington to adapt, apply and assess this     work-based program among a new high risk group to improve the health and safety of law     enforcement officers (LEOs). Fire fighters' work structure is a natural fit for a     team-centered format, and teammates' social support appeared to partially mediate the     intervention's positive outcomes. Although conducive to team formation, LEOs' work lacks the     established team structure of fire fighters. This proposal will apply the team-centered     intervention to LEOs and in the process, learn more about teams as vehicles of health     behavior change, and their relationship with outcomes and other potential mediating variables     in a multilevel ecological analytic framework.   "
153089|NCT01279928|"     This project aimed to explore novel methods of detecting small blood vessel disease in a     paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold     capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory     Blood Pressure Monitoring were used. Each of these techniques investigated different areas of     small blood vessels around the body.      It was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel     investigations would be associated with small blood vessel disease and that widespread     changes to these blood vessels would be detected through associations between the different     novel investigations.   "
153090|NCT01279915|"     A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single     ascending dose of ASP0456 in non-elderly healthy subjects.   "
153091|NCT01279902|"     This study aims; to assess the efficacy of shortened systemic chemotherapy in patients with     completely excised CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) with Ann Arbor Stage I     or II.   "
153092|NCT01279889|"     This study aims to identify women at risk of low blood pressure (hypotension) after the usual     cesarean anesthetic - a spinal anesthetic. Hypotension may be caused by dehydration. We     believe we can predict who will get hypotension by using two anesthesia monitors together     with a passive leg raise (PLR) (legs elevated after a period spent reclining). The PLR will     cause a shift of blood from the legs to the heart, and the monitors will detect the heart's     response to tell if a subject is dehydrated. We want to see if these dehydration tests can     also predict hypotension after a spinal anesthetic.   "
153093|NCT01279876|"     The purpose of this study is to determine whether melatonin is effective in the treatment of     relapsing-remitting multiple sclerosis patients as a supplement to the main disease-modifying     drugs.   "
153094|NCT01279863|"     The VRI technology provides a radiation free dynamic image of the lung, by using a     combination of well-known technologies, i.e. acoustic sensors, and a proprietary algorithm.     The aim of the study is to determine if the VRI examination may contribute to the diagnosis     and follow up of pneumonia in children, and therefore reduce the number of chest radiographs     and the exposure to ionizing radiation. Children referred by ED for chest x-ray,for the     evaluation of pneumonia, will undergo VRI as well. The two modalities will be read     independently and then the findings will be compared, in order to asses the potential role of     the VRI to the management of pneumonia in children.   "
153095|NCT01279850|"     The objective of this investigation is to evaluate the safety and efficacy of long term use     with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions     (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and     whether an additional treatment outcome investigation and/or a post-marketing clinical study     is required in the future will be determined.   "
153096|NCT01279837|"     In this study supported by an American Cancer Society grant, the investigators are evaluating     two levels of swallowing exercise intensity on the maintenance of swallowing muscles and     their function in Head/Neck cancer patients undergoing radiotherapy. Patients in this study     are randomly placed into different exercise groups and provided with exercises to perform     daily during their radiation treatment. Their progress, diet management and swallowing     ability are monitored throughout the treatment period and followed up until 3 months after     radiation treatment. In addition to the daily treatment details, the patients perception of     their swallowing ability and concerns about their health and treatment are also measured.     This clinical trial will help to refine a previously investigated simple exercise package and     provide a program of intervention that can help prevent medically related complications of     swallowing difficulty (e.g. pneumonia, dehydration, prolonged tube feeding), and improve the     ability to eat for patients with head / neck cancer. Ultimately it is hoped that this form of     exercise therapy will help reduce the costs (personal and financial) to the patient,     caregivers and community.   "
153097|NCT01279824|"     Neuromuscular Electrical stimulation (NMES) for swallowing has recently been proposed for the     treatment of dysphagia post stroke and is clinically receiving favor as a treatment modality,     in the absence of strong research support. This study aims to investigate the effect of NMES     therapy for dysphagia upon recovery of swallowing function following stroke. The study will     follow a pilot randomized controlled trial design. Fifty one patients admitted to a sub-acute     rehabilitation facility will be clinically screened for dysphagia, and randomized into one of     three groups, NMES, sham NMES or usual care -behavioral swallowing therapy arm. All patients     will be treated for one hour per day for 3 weeks, and their progress and outcome will be     monitored. The results will add to the preliminary data on the effectiveness of this form of     swallowing treatment for patients following stroke, and has the potential to enable more     efficient allocation of resources to post-acute rehabilitation and thus benefit afforded to     stroke patients, and the community.   "
153098|NCT01279811|"     The purpose of this study is to:        1. Measure the pressure in the spinal fluid surrounding the spinal cord to find out how          well the spinal cord is being supplied with blood.        2. Determine how drugs called vasopressors, which are used to control blood pressure          following SCI (spinal cord injury), influence spinal fluid pressure.        3. Characterize the severity of an SCI using the levels of specific proteins found within          the spinal fluid.        4. Predict how much neurologic recovery may be regained using the levels of specific          proteins within your spinal fluid.        5. Identify proteins within the spinal fluid that will help us learn more about what is          happening after SCI and assist us in developing new treatments for SCI.   "
153102|NCT01279759|"     Background:      An estimated 4000 Anterior Cruciate Ligament Injuries (ACL) occur annually in Norway (Granan     et al., 2004). 1630 primary ACL reconstructions were performed in Norway in 2008 (Norwegian     Arthroplasty Register, 2009). Approximately 120 of these ACL reconstructions were performed     at Haraldsplass Deaconess Hospital.      Physical therapists at our hospital are responsible for postoperative outpatient controls of     patients with a reconstructed anterior cruciate ligament. A clinical observation is that     stair walking (especially downstairs) may be problematic up to 6 months after ACL     reconstruction. One reason may be that the quadriceps muscle is unable to control the knee     when the subject is walking downstairs, and that the knee is perceived to be unstable. Other     contributing factors may be pain and swelling.      It is of interest to know which pre and post operative factors can predict measured and     patient reported function 6 months after ACL reconstruction. Previous research shows that     predictive factors for clinical outcome after ACL reconstruction are anterior knee pain     (Heijne et al., 2009), preoperative electromyography, early postoperative strength (McHugh et     al., 2002), preoperative quadriceps muscle strength deficits, meniscus injury and pain     (Eitzen et al., 2009), obesity, smoking and serious chondrosis (Kowalchuk et al., 2009).      Purpose:        1. To analyse which pre and post operative factors can predict measured and patient          reported function 6 months after Anterior Cruciate Ligament reconstruction.        2. To investigate if there is an asymmetry in step time between the affected and unaffected          leg during down stairs walking, and if degree of asymmetry decreases during a 6 months          period post operatively. Further we want to compare step time asymmetry with other          established outcome measures to investigate sensitivity to change over the observation          period and also compare the patient group in this study with a control group of healthy          subjects to see if asymmetry in the patient group after 6 months is still higher than in          healthy subjects.   "
153103|NCT01279746|"     The purpose of this study is to prove that bedside Ultrasound Compression is a useful     screening tool for the diagnosis of occult deep vein thrombosis in patients presenting to the     emergency room with hypoxia.   "
153104|NCT01279733|"     The main objective of the multi-centered collaborative study is to evaluate the accuracy,     efficacy and clinical advantages of prenatal diagnosis using microarray analysis as compared     with conventional karyotyping.   "
153105|NCT01279720|"     Adenosine deaminase deficiency is an inherited disorder that results in severe abnormalities     of the immune system and leaves children unable to fight infection. This trial aims to treat     adenosine deaminase deficiency patients using gene therapy.   "
153106|NCT01279707|"     The treatment of adult B-cell acute lymphoblastic leukaemia (ALL) has progressed considerably     in the past 3 decades, particularly due to intensification of chemotherapies, improved     supportive care and the incorporation of stem cell transplantation. However, the maximum     tolerability of standard chemotherapeutics has been reached in ALL. Using conventional     chemotherapy, 80-85% of adults with ALL will achieve a complete remission (CR). Unfortunately     treatment at relapse is generally unsuccessful and rarely results, in long-term survival (7%     survival at 5 years). Therefore, the investigators are exploring novel treatment strategies     through the use of monoclonal antibodies (MoAbs) directed at surface antigens on leukaemic     blasts. Using MoAbs directed against surface proteins on B cells has had excellent results in     other B-cell diseases such as low and high grade non-Hodgkin lymphomas, without additional     toxicity. There has also been limited evidence from small studies and case reports of the     efficacy of MoAbs in ALL.      This is a Phase I/II study to determine the safety and tolerability of the combination of     veltuzumab and epratuzumab with intensive chemotherapy in patients with relapsed B-cell ALL.     A maximum of 51 patients will be treated with a combination of UKALL XII induction     chemotherapy and the monoclonal antibodies veltuzumab and epratuzumab. Veltuzumab and     epratuzumab are humanised monoclonal antibodies that target CD20 and CD22 surface proteins,     respectively. Both of these proteins are expressed on ALL tumour B cells.      One group of patients will receive modified UKALL XII chemotherapy + veltuzumab; a second,     modified UKALL XII chemotherapy + epratuzumab and if limited toxicity is found in these first     2 groups, a third group will receive, modified UKALL XII chemotherapy + both veltuzumab and     epratuzumab. Patients will be assessed for safety, tolerability and disease response. Safety     and tolerability will be measured by the number of Dose Limiting Toxicities (DLTs) in each     group. Disease response will be measured by the microscopic appearance of patient bone marrow     samples at day 29, and by molecular tests for tumour cells in bone marrow.   "
153107|NCT01279694|"     Phase I/II trial of Carfilzomib plus melphalan and prednisone in elderly untreated patients     with multiple myeloma. Nine: University Hospital of Nantes, University Hospital of Nancy,     University Hospital of Lille, University Hospital of Tours, department Hospital of La Roche     Sur Yon, University Hospital of Reims, University Hospital of Clermont-Ferrand, University     Hospital of Toulouse, University Hospital of Dijon Newly diagnosed symptomatic Multiple     Myeloma > 65 years. Treatment comprises an initial phase consisting of nine 6-week cycles of     Carfilzomib on Days 1, 2, 8, 9, 22, 23, 29, 30 (carfilzomib is administered at 20 mg/m2 on     Days 1 and 2 of the first cycle and 20, 27, 36 or 45 mg/m2 thereafter) followed by a 12 day     rest period (42-day cycle), in combination with oral Melphalan 9 mg/m² and oral prednisone     60mg/m², both on days 1 to 4.      Phase I: Identification of Maximum Tolerated Dose (MTD)      Carfilzomib will be administered at a dose of 20mg/m² for all doses to the first cohort of 6     patients. If dose-limiting toxicities (DLTs) occurred in fewer than 2 of these patients, the     next cohort of 6 patients (cohort 2) will receive a dose of 20/27 mg/m² where the 20 mg/m²     dose is administered on Day 1 and 2 of Cycle 1 only and then 27 mg/m² for all subsequent     doses. If DLTs occurred in fewer than 2 of the patients in cohort 2, the third cohort of 6     patients will receive a dose of 20/36 mg/m² where the 20 mg/m² dose is administered on Day 1     and 2 of Cycle 1 only and then 36 mg/m² for all subsequent doses. If DLTs occurred in fewer     than 3 of the patients in cohort 3 the fourth cohort of 6 patients will receive a dose of     20/45 mg/m² where the 20 mg/m² dose is administered on Day 1 and 2 of Cycle 1 only and then     45 mg/m² for all subsequent doses. If at any time during cycle 1 of a dose cohort, ≥ 2     subjects experience a drug-related DLT, the MTD will have been exceeded, additional     enrollment within the cohort will cease, and dose escalation will stop. The MTD will be     defined as the dose level below which DLT is observed in ≥ 33% (i.e. ≥ 2 of 6) subjects in a     cohort. The following are defined as DLTs:        -  Any hematologic toxicity of grade 4 intensity or preventing administration of 2 or more          of the 8 carfilzomib doses of the first treatment cycle except a) grade 4          thrombocytopenia without bleeding lasting ≤ 7 days or b) grade 4 neutropenia lasting ≤ 7          days        -  Grade ≥ 3 febrile neutropenia        -  Grade ≥ 3 gastrointestinal toxicities (except for grade ≥ 3 nausea/ vomiting if the          patient had not received adequate antiemetic prophylaxis)        -  Any other grade ≥ 3 nonhematologic toxicity considered related to CMP by the principal          investigator.        -  Grade ≥ 3 peripheral neuropathy persisting for more than 3 weeks after discontinuation          of study drugs.      Adverse events (AEs) will be graded according to National Cancer Institute Common Terminology     Criteria for Adverse Events (NCI CTCAE, version 4.0). MTD determination will be based on     occurrence of DLTs during the first induction treatment cycle only.      Phase II: Expanded Cohort. After identification of the MTD, it is planned for the dose cohort     to be expanded to include up to a total of 20 patients treated at the MTD for the phase II     part of the study. A full treatment course is the same as for phase I: nine 6-week cycles of     CMP.      PRIMARY ENDPOINT Phase I: MTD of combination Phase II: Overall response rate [(ORR),     consisting of complete response (CR), very good partial response (VGPR), and partial response     (PR) SECONDARY ENDPOINTS Safety and tolerability of CMP Clinical benefit response [(CBR = ORR     + minimal response (MR)], Progression-free survival (PFS), Duration of response Overall     survival (OS). Safety data analysis will be conducted on all subjects receiving at least one     dose of study treatment. Analyses will consist of data summaries for reported AEs. The number     and percentage of subjects experiencing one or more AEs will be summarized by dose,     relationship to study drugs, and severity. AEs will be coded using MedDRA terminology.      Disease Response Analyses: Overall response rate (ORR = CR + VGPR + PR) to treatment will be     measured using the International Myeloma Working Group (IMWG) criteria. Clinical benefit     response (CBR = ORR + MR) will be determined using minimal response (at least 6 weeks     duration) as defined by the European Group for Blood and Marrow Transplant (EBMT). The     distribution of subjects by response category will be made overall and by dose cohort.     Time-to-event endpoints will be evaluated with the use of the Kaplan-Meier method and plots     will be provided. Analysis of time-to-event outcomes will be performed for the overall     sample.   "
153108|NCT01279681|"     This randomized phase III trial studies how well combination chemotherapy plus bevacizumab     with or without oxaliplatin works in treating older patients with colorectal cancer that has     spread to other places in the body. Drugs used in chemotherapy work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal     antibodies, such as bevacizumab, may block tumor growth in different ways by targeting     certain cells. Bevacizumab may also stop the growth of cancer by blocking blood flow to the     tumor. It is not yet known whether combination chemotherapy plus bevacizumab is more     effective with or without oxaliplatin in treating colorectal cancer.   "
153109|NCT01279668|"     Persistent cough is a common symptom, accounting for about 20% of referrals to outpatient     chest clinics. Most coughs are caused by self-limiting viral infections such as the common     cold. However, 1 in 4 people with a viral infection develop a persistent cough, which can go     on for several weeks. Whooping cough is a common cause of persistent cough in young people     and adults. Although the whooping cough vaccine gives lifelong protection against severe     infection, it does not appear to give such long-term protection against milder infections,     which can make someone cough for many weeks. There are currently no proven efficacious     treatments for persistent cough following either a viral infection or infection with whooping     cough.      Montelukast is a medication which is already licensed for the treatment of asthma. It works     by blocking the action of chemicals called leukotrienes, which make the airways of people     with asthma inflamed and sensitive. There is strong evidence to suggest that leukotrienes are     also involved in causing persistent cough following viral or whooping cough infection.     Montelukast may therefore also help settle persistent coughs in these settings.      Over 18 months, we will recruit patients aged 16-49 years with a cough lasting 2-8 weeks from     general practices in England. An oral fluid sample will be taken from each participant to be     tested for whooping cough. Participants will be randomly allocated to receive a 28-day course     of montelukast or placebo tablets and asked to complete a daily cough diary for two weeks.     They will be assessed after two weeks by their GP (face-to-face) and after four weeks by     another member of practice clinical staff (telephone). Some participants will be given a     24-hour cough monitor to wear on study entry and at two-week follow-up. This study will be     funded by the National Institute for Health Research's School of Primary Care.   "
153110|NCT01279655|"     In the current study the researchers will firstly investigate whether a bimanual coordination     training protocol (20 min/day, for 8 consecutive weeks) correlates with changes in white     matter architecture and improved upper-limb functionality in patients with multiple     sclerosis. Secondly, the researchers predict that motor learning is more efficient when it is     combined with anodal transcranial direct current (tDCS) stimulation on the left primary motor     cortex.   "
153111|NCT01279642|"     Aimed to compare the success in the peripheral intravenous puncture (PIP), progression and     placement of PICC in children, according to the use of Doppler vascular ultrasound (DVUS) or     traditional method; to identify the influence of the DUVS in the time expended to PICC     placement. Methods: Clinical, randomized and controlled trial conducted after ethical merits     of research endorsement and the obtaining of consent for those responsible for the children.     The sample, calculated in 42 PICC to obtain a power of 0,85, was distributed randomly into     two groups, experimental group (EG) and controlled group (CG). To the statistical analyzes     Pearson Chi-square, Fisher's Exact Tests, Generalization of Fischer's Exact and Mann-Whitney     tests was applied (5%). Of the 42 catheters, 21 (50.0%) were implemented in EG and 21 (50.0%)     in CG. The PIP was obtained in the first attempt in 90.5% of the punctures of the EG and in     47.6% of the GC, (p=0.003). PICC were implanted successfully in 18 (85.7%) children of GE and     11 (61.1%) of CG (p = 0.019). The median of the time spent to the procedure was significantly     higher (p=0.001) in CG (50 minutes) when compared to EG (median 20 minutes).   "
153113|NCT01279616|"     Majority of patients who are eligible for allogeneic HSCT for cure of severe sickle cell     disease lack a matched family donor. This study aims for cure of sickle cell disease by     performing unrelated donor (outside family) allogeneic HSCT. Donors or unrelated cord blood     units will be selected from the NMDP database. It is designed to estimate the safety of a     novel reduced toxicity, yet an immunosuppressive and myeloablative preparative regimen. This     is meant for patients <21 years old who have severe complications from sickle cell and do not     have matched sibling donors in the family to undergo stem cell transplant. Patients will     undergo transplant using unrelated donor stem cells after receiving the protocol therapy.     They will be followed for 1 year to monitor for engraftment of donor cells and complications     like graft versus host disease (GVHD), infections and death.   "
153114|NCT01279603|"     This clinical trial is about testing GO-203-2c, which is a newly discovered compound that     binds to an oncoprotein (a cancer causing protein) called MUC1 (which is over-expressed in     many cancers). By binding to MUC1, GO-203-2c eventually causes tumor cell death in laboratory     studies.      This study is being done to:        -  Test the safety of GO-203-2c and see what effects (good and bad) it has on you and your          cancer        -  Find the highest dose of GO-203-2c that can be given without causing bad side effects        -  Examine how much GO-203-2c is in the blood at certain times after it is given and how          quickly the body gets rid of it        -  Observe whether there is any effect of GO-203-2c on the size and activity of cancer in          your body   "
153115|NCT01279590|"     The purpose of this study is to assess the incidence of statin-associated myalgia (SAM) with     treatment with PPD10558 versus atorvastatin in patients previously intolerant to statins.      To assess the safety and tolerability of PPD10558 compared to atorvastatin in patients     previously intolerant to statins.   "
153116|NCT01279577|"     This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland,     only.      This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO     suspension vs. placebo for the induction of remission in Crohn's disease.   "
153117|NCT01279564|"     Airway management is one of the most important tasks facing the physician, especially the     anesthesiologist. Fast and correct performance of endotracheal intubations done as normal     routine in the operating room, but can save life everywhere.      To make intubation easier, several newly designed tubes and laryngoscopes are developed and     tested every year. Their performance is evaluated subjectively by the acting     anesthesiologist, and by using objective parameters such as speed of intubation, the force     applied during laryngoscopy , or catecholamines secretion during intubation as a stress     parameter . The studies set for testing these parameters lead to establish accepted     indications for the treatment of the airway in cases of anticipated and unanticipated     difficult airway.      In the present study we will compare the performance parameters of intubation using Etview     Tracheoscopic Ventilation Tube - TVT to the standard tube, of which most of daily intubations     are carried with. The Etview TVT is similar to the standard endotracheal tube; its outer     dimensions and material is exactly as the standard tube, the difference is only the inner     fiber of the camera.   "
153118|NCT01279551|"     This study wants demonstrate that the use of 0.4% nitroglycerin ointment can reduce the     postoperative pain related to anorectal spasm (anismus) while performing a stapled     haemorrhoidopexy.   "
153119|NCT01279538|"     The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD),     safety and tolerability of ASKP1240 when administered to subjects who received a de novo     kidney transplant.   "
153120|NCT01279525|"     The purpose of this study is to determine the effectiveness of a multifactorial intervention     program to prevent falls among the elderly as compared to a brief intervention.   "
153121|NCT01279512|"     This study is a prospective randomized clinical trial to compare the endocrine and metabolic     effects of two anti diabetic drugs (metformin vs. acarbose) in infertile overweight women     with PCOS   "
153122|NCT01279499|"     The objective of this prospective randomized clinical study was to compare anesthesia, in     morbidly obese patents (BMI >50) who underwent BPD-RYGBP with either sevoflurane or propofol     with remifentanyl.   "
153123|NCT01279486|"     Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to     the UK trial centre.      Volunteers will be required to use the Clearblue Pregnancy Test according to the product     instructions, and provide a urine sample from the same void.      Trained technicians will conduct a second test from the urine sample.   "
153124|NCT01279473|"     This study will investigate if nilotinib provides an improved safety and efficacy profile     over that seen in patients receiving Imatinib.   "
153125|NCT01279460|"     This study aimed to investigate in a cohort with chronic kidney disease the longitudinal     relationship between aortic stiffness and renal function and mortality.   "
153126|NCT01279447|"     The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve     blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving     long term outcome scores after knee arthroscopy.   "
153127|NCT01279434|"     Nonalcoholic fatty liver disease (NAFLD) is a spectrum of hepatic pathology, ranging from     simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a     more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as     infiltration of inflammatory cells. Since, both vitamin E and PTX has been found to improve     NASH when used alone, a combination of these two should be expected to give better results     because of targeting two different pathogenetic mechanisms (cytokines amplification and     oxidative stress) in NASH patients. This will be open labelled, prospective, randomized     study. The diagnosis of NAFLD will be made on the basis of Ultrasonographic findings     suggestive of fatty liver and presence of insulin resistance or features of metabolic     syndrome. Subsequently histologic confirmation of the diagnosis of NASH will be made in all     cases.   "
153144|NCT01279213|"     augmentation of clozapine with paliperidone in the treatment of resistant schizophrenia has     not been tested until now in randomized controlled trials. This combination is supposed to     have therapeutic efficacy in the treatment of resistant schizophrenia.   "
153327|NCT01276834|"     To compare in a prospective randomised way the effect of two different immunosuppressive     regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery     calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after     transplantation.   "
153128|NCT01279421|"     This project will first increase the accessibility and acceptability of rapid HIV testing in     health clinics located in or near four low-income communities in San Salvador, El Salvador.     The investigators will use crack users' social networks and small incentives, as recommended     by the CDC, in collaboration with the Salvadoran Ministry of Public Health and Social     Assistance (MSPAS) to encourage crack users to receive HIV testing. The second part of the     intervention consists of training 8 Peer Leaders to recruit and lead a Peer Network     Intervention among 400 crack users to change norms supporting HIV protective behaviors. The     intervention will include monthly meetings open to crack using and non-crack using community     residents to reinforce HIV risk reduction skills, and discussion of other topics related to     HIV such as illicit drug use and interpersonal violence and community-wide HIV awareness     events. Our hypothesis is that these two intervention features will singly, and in     combination, reduce HIV risk behaviors among Salvadoran crack users.   "
153129|NCT01279408|"     The aim of the study is to assess current practice within PROP & lung teams, for treating     asymptomatic patients with centrally located non-small cell lung cancer (NSCLC), and to     observe outcomes for those patients receiving immediate or deferred RT. This is a prospective     cohort trial. Patients will be managed by immediate radiotherapy (RT) or a deferred approach     according to physicians' individual current clinical practice. Baseline and follow-up data     collection will be structured to focus on patient-reported measures to describe clinical     outcomes in the two management groups. Indications for prescribing RT and dose fractionation     schedules will also be collected. A new intervention will not be introduced during this     trial. Instead, a follow-up regimen will be offered to both groups of patients, so that RT     can be offered to the deferred group of patients if/when symptoms develop, and we can monitor     symptoms/toxicities and QoL in both groups of patients.   "
153130|NCT01279395|"     We hypothesize that administration of anti-inflammatory medications such as celecoxib,     naprosyn and diclofenac will cause changes in the blood plasma and white blood cells of     patients such that they will be less able to efficiently process cholesterol.   "
153131|NCT01279382|"     In this trial, the effects of two psychological interventions - i.e. hypnotherapy and     relaxation training - are compared with care as usual in IBS treatment. The investigators     hypothesized that hypnotherapy is most effective in reducing complaints in IBS.   "
153132|NCT01279369|"     The purpose of this study is to determine if the presence of fetal fibronectin in the     cervicovaginal secretions of pregnant patients with minor maternal trauma predicts impending     preterm delivery due to abruptio placenta.   "
153133|NCT01279356|"     Liver diseases such as non-alcoholic fatty liver disease (NAFLD), alcoholic liver disease     (ALD) and viral hepatitis have the potential to progress to cirrhosis and finally     hepatocellular carcinoma (HCC). Early diagnosis and treatment of liver diseases is important     since progression is likely and is associated with significant morbidity and mortality.     However, in daily clinical practice no specific and non-invasive biomarkers are used for the     diagnosis and follow-up of patients with liver diseases. It is known that patients with liver     diseases produce compounds that can be excreted in breath as a consequence of metabolic     processes, inflammation and/or oxidative stress. These are called volatile organic compounds     (VOCs). Analysis of VOCs in exhaled air has been reported to provide valuable information in     patients with chronic obstructive lung disease (COPD) and inflammatory bowel disease (IBD).     Also, in patients with liver disease, exhaled VOCs have been detected.      The investigators hypothesize that analysis of VOCs in exhaled air of patients with liver     diseases can be used for diagnosis and follow-up.   "
153134|NCT01279343|"     The purpose of this study is to compare the efficacy of the combination of the supracervical     foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We     hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter     induction to delivery time.   "
153135|NCT01279330|"     The propose of this study is to assess the effect of general practitioner's involvement in     the stimulus invitation letter in colorectal cancer screening compared to sending the patient     home test (stimulus 2 of reference as contained in the specifications).   "
153136|NCT01279317|"     The main objective of this study is to assess the acute effect of co-ingested vinegar on     postprandial plasma glucose levels in type 2 diabetes patients.   "
153137|NCT01279304|"     The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in     cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with > 3 pathologic     axillary nodes on imaging) breast cancer patients, treated with neoadjuvant chemotherapy,     breast surgery, and radiotherapy that is protocolized based on the pathology findings after     chemotherapy and definitive surgery (ypTNM stage).   "
153138|NCT01279291|"     This is a two-part, Phase 1, open-label, multicenter, dose escalation study of KHK2866 as     monotherapy in patients with advanced solid tumors, and in combination with chemotherapy in     subjects platinum-sensitive and platinum-resistant ovarian cancer.   "
153139|NCT01279278|"     The propose of this study is to assess the effect of general practitioner's involvement on     first patients' solicitation in screening for colorectal cancer by testing for faecal occult     blood (FOBT).   "
153140|NCT01279265|"     This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen     A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with     Lactobacillus GG (LGG)) during 3 months of formula feeding. The investigators' aims are to     compare 3 outcomes in these babies: (1) normal baby crying time; (2) the composition of     intestinal microbiota (bacteria in the stool); and (3) a lab test which measures the number     of white blood cells in the large intestine (fecal calprotectin). The investigators predict     that LGG supplementation (Nutramigen-Enflora) will facilitate its establishment as an     important component of the neonatal intestinal microbial community and reduce fecal     calprotectin.   "
153141|NCT01279252|"     The purpose of this study is to evaluate whether patients with previously untreated, early     stage CLL respond to empirical broad spectrum antibiotics and therefore test the hypothesis     that occult bacterial infections are involved in the induction and maintenance of CLL.   "
153142|NCT01279239|"     The aim of this study is to establish plasma metabonomics fingerprinting atlas for severe     multiple trauma patient using 1H nuclear magnetic resonance (NMR) based metabonomics     methodology and advanced mathematics tools.   "
153146|NCT01279187|"     Good bone healing and bone build-up are necessary for the success of dental implants.     Research in animals and humans has shown that a drug, called Forteo, can increase bone     build-up and bone strength over time. Forteo has been approved by the Food and Drug     Administration (FDA) for use in patients with a condition where bone is broken down and     weakened, called osteoporosis. The investigators do not know, however, whether Forteo is     effective for use in humans for improving bone healing after implant placement, and whether     it will have the same bone-building and bone-strengthening effects as for patients with     osteoporosis. This research study is being done to learn what effect 7 weeks of treatment     with Forteo will have on bone build-up and strengthening of bone for patients receiving     implants.   "
153147|NCT01279174|"     Osteoarthritis (OA) is the most common degenerative arthropathy. Load-bearing joints such as     knee and hip are more often affected than spine or hands. The prevalence of gonarthrosis is     generally higher than that of coxarthrosis.      Because no cure for OA exists, the main emphasis of therapy is analgesic treatment through     either mobility or medication. Non-pharmacologic treatment is the first step, followed by the     addition of analgesic medication, and ultimately by surgery.      The goal of non-pharmacologic and non-invasive therapy is to improve neuromuscular function,     which in turn both prevents formation of and delays progression of OA. A modification of     conventional physiotherapy, whole body vibration has been successfully employed for several     years. Since its introduction, this therapy is in wide use at our facility not only for     gonarthrosis, but also coxarthrosis and other diseases leading to muscular imbalance.   "
153148|NCT01279161|"     The project aims at assessment of the effect of the FTO gene polymorphism and the type of     treatment on the development of overweight/obesity and features of metabolic syndrome in     children with type 1 diabetes.      Gene polymorphism including some genetic variants may predispose to the development of     cardiovascular diseases and their complications. The A allele of the FTO gene predisposing to     obesity occurs in approximately 40% of the European population and each copy of this allele     can increase BMI by 0.1 Z-score i.e. by 0.4 kg/m2. Insulin therapy in diabetic patients may     result in excess body weight gain. Therefore we need studies involving large groups of     children and assessing cardiovascular risk factors in type 1 diabetes along with their     genetic associations.      Patients: The study will include 1500 children with type 1 diabetes, aged 6-18 years.     Reference group will be made of 1500 children in whom type 1 diabetes was excluded. The     following variables will be assessed in the treatment group: 1) Anthropometric data and     questionnaire data: age, sex, body height and weight, body mass index (BMI), waist and hip     circumferences, arm and thigh circumferences, family history of overweight/obesity, type 1 or     2 diabetes or cardiovascular disease, 2) Primary disease characteristics: age of the disease     onset, treatment regimen, mean daily insulin consumption per kg body weight, brands of     insulin products, glycated haemoglobin, BMI from the first 3-6 months following diabetes     onset, diet, conversion of these data into actual and ideal calorie intake 3) Laboratory data     - lipid profile and blood pressure (average of three measurements). Methodology: Gene     polymorphism analysis in the extracted DNA will be made with the real-time PCR method using     TaqMan 7900 HT by Applied Biosystems. Correlations between the FTO gene polymorphism and     clinical variables such as BMI (including BMI increase since the disease onset), body weight     and height, waist and hip circumferences, arm and thigh circumferences, and blood pressure     will be assessed by a professional statistician with a specially dedicated software. Moreover     parameters such as diet and metabolic control will be assessed. As regards insulin therapy     the following variables will be analysed: insulin injection device, therapy regimen     (intensive versus functional; brands and types of insulin products: human insulin versus     insulin analogue), consumption of insulin. All of the above listed variables will be     correlated with the genotypes found in the gene polymorphism analysis. The study has been     approved by Bioethics Committee of the Medical University in Białystok.      Results: The authors of the project expect that the effect of the FTO gene polymorphism on     overweight/obesity and features of metabolic syndrome in children with type 1 diabetes will     be shown. Moreover the project will enable assessment of the effect of the therapeutic     regimen, including the type of insulin product, on body weight increase in the course of type     1 diabetes treatment in the context of the FTO gene polymorphism. Confirmation of the above     associations and identification of a group at risk of excess body weight increase in the     course of insulin therapy may help physicians, parents and patients to avoid this     complication. Therefore clinical benefit of this project will include identification - based     on the genetic assays results - of a group of type 1 diabetic children particularly likely to     develop overweight, obesity and other cardiovascular risk factors.   "
153149|NCT01279148|"     This prospective, randomized, controlled, parallel-design trial will compare the use of     electromagnetic tracking and image guidance during biopsy/ablation procedures verses the     typical standard or conventional image guided procedure alone (control). US     ultrasound-guided biopsies/ablations with or without CT computed tomography- imaging will     be used to complete the procedures in either the CT suite or a procedure room, at the     discretion of the physician, and according to normal local practice patterns.   "
153150|NCT01279135|"     The study tests Tomtherapy based Image Guided Radiation against conventional radiation     techniques for it's ability to reduce long term small bowel toxicity.   "
153151|NCT01279122|"     The purpose of this study is to look at how well you see the Nanoflex Intraocular lens placed     in your eye.   "
153152|NCT01279109|"     The purpose of this study is to examine whether we can use social networks to spread health     information and health behaviors during pregnancy to prevent excessive gestational weight     gain.   "
153153|NCT01279096|"     The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited     Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with     etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and     safety of this combination regimen to treat children with high risk relapsed or refractory     acute lymphoblastic leukemia (ALL).   "
153154|NCT01279083|"     To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects     with primary open-angle glaucoma or ocular hypertension.   "
153155|NCT01279070|"     The purpose of this study was to develop an integrative intervention for schizophrenia taking     into account previous efficacious therapies. Thus, our aim was to evaluate the efficacy of     our cognitive remediation group training: Problem Solving and Cognitive Flexibility training     (REPYFLEC), focused to improve neurocognition and functioning in schizophrenia patients. We     hypothesized that training executive function and metacognition would allow us to achieve     improvements in neurocognition, functioning and psychiatric symptoms of patients with     schizophrenia.   "
153156|NCT01279057|"     This study will compare the safety and efficacy of a generic Fluticasone Furoate (Lek     Pharmaceuticals ) Nasal Spray to the reference listed drug in the treatment of seasonal     allergic rhinitis. Additionally both the test and the reference formulations will be tested     for superiority against a placebo nasal spray.   "
153157|NCT01279044|"     The purpose of this study is to determine if persons randomized to receive adapted     Personalized Cognitive Risk-reduction Counseling (PCC) will report greater reductions in     unprotected anal sex behavior compared with persons who do not receive Personalized Cognitive     Risk-reduction Counseling (PCC).   "
153158|NCT01279031|"     The purpose of this study is to look at the outcomes of your vision after your cataract     surgery based on two different types of equipment that will be used during your surgery.   "
153159|NCT01279018|"     Breast cancer treatment is for many patients followed by sequelae, such as persistent pain,     sensory disturbances, lymphedema and reduced physical function. These undesired consequences     of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory     disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients.     Development of persistent pain after breast cancer treatment, involves a complex     pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors     for the development of persistent pain after breast cancer treatment have been identified;     young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is a     well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this     nationwide study is to retrospectively examine a cohort of breast cancer patients treated     with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of     persistent pain and other sequelae.   "
153160|NCT01279005|"     Four focus groups , each of 10-15 males, ages 20-50 years old, MSM will be conducted by a     medical sociologist. Two groups will be HIV negative participants and two groups of HIV     positive MSM. Every group will meet for two hours. The focus group will be recorded and the     collected data will be processed further for evaluation and extraction of the relevant     information.      The volunteers will sign an inform consent prior to entrance to the study.   "
153200|NCT01278485|"     This is a multicenter, observational, retrospective and cross-sectional study to be conducted     in a cohort of consecutively selected participants with type 2 diabetes mellitus (T2DM) who     have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination     therapy by their cardiologist, nephrologist, or family practice doctor for at least 6 months     prior to study enrollment.      The purpose of the study is to assess treatment patterns, goal attainment rates, long-term     diabetes complication rates, and frequency and severity of hypoglycemic episodes among T2DM     participants treated in cardiology, nephrology and family practice settings.   "
153164|NCT01278953|"     The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing     catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be     randomized for treatment with either the TactiCath catheter or another ablation catheter with     no contact force sensing capability. Patients will be followed for 12 months to compare the     incidence of serious adverse events and freedom from recurring, symptomatic AF between the     two study arms. Additional measures of treatment success including quality of life,     recurrence of asymptomatic AF and procedural efficiency will also be studied.      A second phase of the study will treat up to 50 non-randomized subjects with a new version of     the device under the same protocol.   "
153165|NCT01278940|"     PRIMARY OBJECTIVES: Determination of safety and toxicity of vaccination with patients` tumour     mRNA transfected DCs .      SECONDARY OBJECTIVES:Determine immunological response to the vaccine (induction of specific     T-cell response) and assessment of tumour response   "
153166|NCT01278927|"     This is a Phase III, randomized, unblinded, multicenter, prospective comparative study. The     purpose of this study is to test whether exercise or stress management training delivered to     autologous and allogeneic hematopoietic cell transplantation (HCT) patients prior to     transplantation can improve functional status and the transplant experience.   "
153167|NCT01278914|"     PRIMARY OBJECTIVES:      Determination of safety and toxicity of vaccination with mRNA transfected DC (based on blood     samples, and adverse events).      SECONDARY OBJECTIVES:      Determine immunological response to the vaccine (induction of specific T-cell response) and     assessment of tumour response.   "
153168|NCT01278901|"     STUDY PROTOCOL:      The study will include 30 patients ages 18-80y that had a gastroscopy for various reasons.     The patients should not be on PPI therapy . If during the gastroscopy there are some     pathologies that require a second look endoscopy after some weeks of therapy (ulcers or     esophagitis), the investigators will repeat the gastroscopy within a month.      During the first gastroscopy a biopsy will be taken for histological examination and for a     rapid urease test and an urea breath test will be done soon after the procedure.      If one of the tests is positive the investigators postulate that the Helicobacter pylori is     actually present.      After the gastroscopy the patient is given a full dose of PPI (as indicated) and helicobacter     tests are repeated in the next endoscopy (under PPI therapy) . Any positive test that become     negative in the second endoscopy is considered false negative.   "
153169|NCT01278888|"     Is thoracoscopic surgery better than traditional open surgery for lung cancer?      Video assisted thoracoscopic surgery for lung cancer (VATS) is presumed to be less traumatic     than traditional open surgery for lung cancer but this has never been documented in a     randomized trial. Some surgeons hesitate to use VATS because it is technically more     demanding, others question if the two methods are oncologically equal. Regardless, VATS has     been implemented as a routine method for lung cancer surgery several places around the world     including Odense University Hospital. The investigators have launched the first randomized     controlled trial in the world comparing the two surgical methods to investigate any     differences in length of hospitalization, postoperative pain, life quality within the first     year, and health economical aspects.      The investigators include patients with stage I and II lung cancer, and randomize between     VATS and open surgery in a design where both the patient and doctors doing general rounds in     the ward are blinded until discharge because the dressing on the surgical wound is identical,     regardless of the surgical method. The surgeon cannot influence clinical decisions including     time to discharge, which is decided by other specialist surgeons. Pain evaluation is     performed 6 times daily using the VAS-score, life quality is evaluated continuously during     the first 12 months using EQ5D and EORTC QLQC-30 questionnaires, and the consumption of     analgetics in both groups are monitored via the national prescription database.      Parallel to this trial a similar clinical study, which is also the first of its kind in the     world, has been launched for patients with lung cancers not eligible for VATS. They are     randomized between the two traditional open surgical methods (anterolateral and     posterolateral thoracotomy) - this is also blinded to both patient and doctors doing rounds     until discharge from hospital, and endpoint are similar in the two studies.      250 patients will be asked to participate in each study - so far, 91 patients has been     randomized and patient accrual is beginning soon at Skejby University Hospital,Denmark in     collaboration with surgeons from department of thoracic surgery.   "
153170|NCT01278875|"     High density lipoproteins (HDL) have many effects that protect against cardiovascular     diseases. In an acute heart attack (acute coronary syndrome -ACS), HDL change in composition     and structure, reflecting the inflammatory environment that accompanies an ACS. The     investigators will examine the function of HDL during an ACS and again when the patient has     recovered.   "
153171|NCT01278862|"     Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided     Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled     using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand     fabricated porcelain covering.   "
153172|NCT01278849|"     This study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v.     administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying     degrees of hepatic impairment. The study will be carried out in cancer volunteer patients     (utilizing controls with normal hepatic function) who will be assigned to four hepatic     impairment groups according to their pre-dose (Day-1) and total bilirubin level. The study     will consist of two phases, a (Core Phase) that will evaluate the pharmacokinetics of a     single i.v. dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired     hepatic function, and compared to controls with normal hepatic function. The assessments will     be done on the safety and tolerability of that single dose in adult cancer patients with     impaired hepatic function and compared to controls with normal hepatic function. The     Extension Phase will consist of assessing the safety and tolerability of ASA404 at the same     three doses in combination with a sponsor-approved taxane-based regimen in adult cancer     patients with impaired hepatic function and compared to controls with normal hepatic     function.   "
153173|NCT01278836|"     The purpose of this study is to determine the effects of fasciocutaneous flaps for leg     defects.   "
153174|NCT01278823|"     The purpose of this study is to determine the effects of bariatric surgery on blood sugar     control and underlying mechanisms that contribute to type 2 diabetes in men and women with a     BMI between 27 and 42. Sixty subjects will be randomized to either undergo the roux-en-y     gastric bypass operation or intensive medical, dietary and exercise management.   "
153175|NCT01278810|"     To assess safety, tolerance and PK profile of different doses(50mg,100mg,200mg,300mg, 400mg,     500mg,QD)of Icaritin in advanced breast cancer Patients in China   "
153176|NCT01278797|"     This study will be an open-label, randomized, two-treatment, two-period, two-sequence     crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer     Ingelheim Pharma GmbH & Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination     tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).   "
154914|NCT01256151|"     To assess if the sublingual tablet will have similar pharmacokinetics as the conventional     tablet of alprazolam.   "
153177|NCT01278784|"     The dry eye syndrome DES is a highly prevalent ocular disease, in particular in the elderly     population. One mainstay of therapy for patients suffering from DES is the use of topically     administered lubricants. However, despite many efforts, no ideal formulation has yet been     found.      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for     treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with     favourable biological properties such as high biocompatibility and low toxicity.     Additionally, the new formulation comprises N-acetylcysteine, which has been used in     ophthalmology because of its mucolytic properties for several years. Based on theoretical     considerations, one can hypothesize that the new chitosan derivative may show an increased     adhesion to mucins of the ocular surface and may therefore be particularly beneficial in     reducing the symptoms associated with DES. We have recently shown in a phase I trial that     single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young healthy     subjects. However, due to the fact that intraocular pressure has been measured as one of the     main safety variables, topical anesthesia was necessary. Thus, the data about local ocular     discomfort after administration are limited. This trial seeks to investigate whether single     instillation of chitosan-N-acetylcystein leads to ocular discomfort such as burning and     stinging.   "
153178|NCT01278771|"     This is a retrospective study. The investigators shall review the angiography data of 1200     consecutive cardiac catheterizations of children and babies with CHD (Congenital Heart     Disease) since 1998 till now.      Coronary artery origin and course will be evaluated in relation to the morphologic cardiac     anomalies.      Coronary artery anomalies will be described and statistical analysis will be performed.   "
153179|NCT01278758|"     The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in     patients with refractory or relapsed metastatic cancer with impaired renal function and with     normal renal function. It is very possible that patients with renal impairment will show     differences in renal excretion of parent ASA404 and its metabolites, warranting a study that     leads to a better pharmacokinetic assesssment in this population.   "
153180|NCT01278745|"     All people who have a heart transplant are at risk for developing cardiac allograft     vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated     with poor heart transplant function. People who develop antibodies after transplant have a     higher risk of developing CAV. Infections, high cholesterol, and rejection also increase the     risk of developing CAV. People who develop CAV usually have to receive another transplant.   "
153181|NCT01278732|"     The investigators aim to investigate whether central systolic blood pressure, as measured     during regular 24 hour ambulatory blood pressure monitoring (ABPM), is a better predictor of     left ventricular mass than peripheral systolic blood pressure during ABPM.   "
153182|NCT01278719|"     Nasal polyp is a significant health problem with a prevalence of 4%. It is increased in     patients with asthma (7-15%), Cystic fibrosis (39-56%) or aspirin intolerance (36-96%).The     quality of life (QOL) is worse than in patients suffering from hypertension, migraine, angina     pectoris and head & neck cancer as per a previous study by Videler WJM et al.QOL is in     comparison to chronic obstructive pulmonary disease.The reason why it develops in some and     not in others remains unknown despite the disease being present for centuries.A definite     relationship exists in patients with 'Sampter triad': Asthma, non steroidal anti-inflammatory     drug sensitivity and nasal polyps. But not all patients with NSAID sensitivity have nasal     polyps and vice verse.      Etiology is largely unknown despite the disease being present for centuries. Although the     factors like wood stove exposure, smoking, allergic rhinitis, rhino sinusitis have been     strongly implicated in literature from various studies, most data available is on ethmoidal     polyps.The present study is an attempt to study the association of important risk factors     with both antrochoanal(AC) and ethmoidal nasal polyps(EP).One study found that a     significantly smaller proportion of the population with polyps were smokers compared to the     unselected population (15% v/s 35%). But this is not confirmed by other studies.      Seven percent of asthma patients have nasal polyps and in non atopic asthma and late onset     asthma, polyps are diagnosed more frequently (10-15%).Eosinophil numbers are significantly     higher in nasal polyp tissue and further increased in patients with co-morbid asthma and     aspirin sensitivity.      Nasal colonization in increased amounts was found by Staphylococcus aureus and presence of     specific Immunoglobulin E directed against S.aureus enterotoxins was found. Rates of     colonization and IgE presence in nasal polyp tissue were increased in subjects with nasal     polyp associated with co-morbid asthma and aspirin sensitivity.      Nasal polyps are frequently found to run in families, suggesting a hereditary or with shared     environmental factor. In the study by Rugina et al., more than half of 224 nasal polyp     patients (52%) had a positive family history while the study by Greisener et.al, reported 14%     of family history strongly suggesting hereditary factors in the pathogenesis of nasal polyps.      Some studies have found environmental factors like smoking and those using wood stove as a     primary source of heating with the development of nasal polyps. The studies are contrasting.      There is presently a need of understanding the differences in the pathogenesis of     antrochoanal polyp and ethmoidal nasal polyp clearly.There are hardly any concrete research     performed on them to note the differences in the etiology and their pathogenesis. Hence the     study is undertaken to extensively study the etiologies responsible for them and to note the     differences.   "
153183|NCT01278706|"     Endometrial biopsy has been shown to improve IVF pregnancy and live birth rates. The optimal     time of performing the biopsy is yet to be established.      In this study, the investigators will compare different temporal timing of the biopsies with     regards to the menstrual cycle and their affect on the success rates of the treatment.   "
153184|NCT01278693|"     The purpose of this study is to determine Effect of oral L-carnitine supplement on lipid     profile, anemia, and quality of life.   "
153185|NCT01278680|"     Employees of Blue Shield of California (BSC) will be recruited to participate to regularly     use Walkstations. Some participants will be randomly assigned to a hold out control     condition and the remainder will be assigned to one of two experimental treatments: Personal     Incentive vs. Charitable Incentive. In the Personal Incentive condition people will be paid     $3 for every completed Walkstation session, whereas for participants in the Charitable     Incentive condition $3 will be donated to a specific charity. The incentives will operate for     approximately 45 days and then for an additional 45 days participants in the two experimental     conditions will have access to the Walkstations. Participants in the hold out control     condition will begin using the Walkstations after the initial 90 day period.   "
153186|NCT01278667|"     Children with ADHD are in high risk to develope social difficulties. The present study will     examine the emotional processing in those children. The main purpose is to investigate the     connection between memory and recognition of facial expressions, how those abilities     influence social functioning and if Methylphenidate influence the emotional processing.      The study will include 80 children in ages 9-12 years, devided in 2 groups; children with     ADHD treated with Methylphenidate, and healthy children without ADHD. The children will do     computerized tasks that examine recognition and memory of facial expressions. Social function     will be examined by questionnaires filled by parents and teachers.   "
153328|NCT01276821|"     To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity     scores among children aged 6 weeks to 24 months with bronchiolitis.   "
153187|NCT01278654|"     The purpose of the study is to learn more about effective ways to motivate people to increase     their non-exercise energy expenditure exercise. This is an important research question     because obesity and weight-related issues are increasingly becoming a problem in America.     This project will address this research question by testing the effect of two different     incentive schemes in motivating employees who are predominantly sedentary to use Walkstations     at work. The Walkstations are treadmills that move at a very slow rate (maximum 2miles /     hour) and are attached to a work station (i.e. with computer and telephone); they therefore     are designed to increase energy spent not through heavy exercise, but through small changes     in posture and movement associated with routines in daily life (called nonexercise activity     thermogenesis or NEAT).      Subjects will be employees of Blue Cross Blue Shield of Massachusetts (BCBSMA). Subjects will     be the control participants from the previous Walkstation study we ran with BCBSMA. All 120     control participants from this previous study will be told that they can now participate in a     study that involves the Walkstations (up until now, they have not been given access to the     Walkstations). These participants from the previous study will be sent an email informing     them that they are eligible to participate in this new Walkstation pilot. Those who are     interested in participating will then be invited to sign up for an enrollment session. There     will be no incentives for participating in the initial enrollment session. For the 2 month     follow-up session, participants will have a chance to win 1 of 3 prizes (1 * $100, 2 * $50)     for completing the follow-up.   "
153188|NCT01278641|"     A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or     Chronic Widespread Pain (Wolfe 1990) participate in the study.      The main objective of the study is to compare the effect of a graded strength training     program and a low intensive pool exercise program.   "
153189|NCT01278628|"     Physical activity is considered important in prevention and treatment of obesity and     metabolic syndrome. Genotype of genes involved in metabolism is also known to be associated     with the development of metabolic syndrome. However, scarce evidence exists regarding the     influence of physical activity intensity and genotype on metabolic syndrome in people with     obesity. The investigators examine physical activity using an uniaxial accelerometer, as well     as aerobic fitness using an electric bicycle ergometer, several genotypes of genes related to     glucose and lipid metabolisms in middle-aged men with obesity and/or abdominal obesity who     were employees in silicon wafer manufacture and participated in a health checkup.   "
153190|NCT01278615|"     This phase II clinical trial is studying how well selumetinib works in treating patients with     relapsed or refractory diffuse large B-cell lymphoma. Selumetinib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth.   "
153191|NCT01278602|"     The aim of study is to prove R-ESHAP regimen followed by autologous stem cell transplantation     as salvage treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is     effective.   "
153192|NCT01278589|"     The purpose of this study is to evaluate the antioxidant effect of Plantago asiatica L.     extract in subjects with mild hyperlipidemia.   "
153193|NCT01278576|"     The study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between     two different injection sites, namely at the proximal portion of the gastrocnemius(GCM)     versus at the midbelly of the GCM.   "
153194|NCT01278563|"     Epidemiological studies suggest a role for a low glycemic index (GI) diet in the management     of obesity and associated metabolic risks including diabetes. However, evidence from     long-term, randomized controlled trials exploring the relationship between low GI diet,     weight reduction and glycemia, particularly in children and adolescents, is lacking. Modern     food-processing technology has produced many food products with high GI which may contribute     to the burgeoning epidemic of obesity worldwide. Since dietary habits are shaped in early     life, adolescence is a critical period to educate our young people to acquire a healthy     eating habit to prevent obesity.      The investigators hypothesized that, in Chinese adolescents, low GI diet results in greater     reduction in body mass index and body fat percentage, enhanced insulin sensitivity and     favorable changes of cardiometabolic risk factors compared to conventional diet after 12     months of intervention.      This study is a randomized controlled trial of a low GI (<55) versus conventional Chinese     diet (GI>/=70) in adolescents (12-month intervention followed by a 6-month observational     period) to study; 1) the changes in body mass index and obesity associated changes in     cardiometabolic profile; 2) the underlying hormonal factors associated with these changes.   "
153195|NCT01278550|"     Low-dose aspirin is the mainstay of treatment for patients with coronary heart disease and     stroke. However, low-dose aspirin increases the risk of ulcer bleeding. Current evidence     indicates that 80 - 100 mg of aspirin daily provides good protection against vascular events     and the risk of ulcer bleeding is low (about 1% per year). Since the overall risk of bleeding     is low, aspirin users who do not have previous ulcer disease do not require prophylaxis with     anti-ulcer drugs. In contrast, aspirin users with a history of ulcer disease have a 2- to     4-fold increased risk of ulcer bleeding. The best strategy for reducing the risk of bleeding     in high-risk aspirin users remains unclear. Current strategies for high-risk patients include     the use of anti-ulcer drugs, elimination of risk factors (e.g. Helicobacter pylori). Recently     the investigators have shown that among aspirin users who are infected with H. pylori, the     eradication of H. pylori is comparable to omeprazole, a proton pump inhibitor (PPI), in     preventing recurrent ulcer bleeding in 6 months.      The investigators postulated that among patients with H. pylori infection and a history of     ulcer bleeding who continue to use low-dose aspirin, the long-term risk of ulcer     complications after eradication of H. pylori is comparable to that of average-risk aspirin     users.   "
153196|NCT01278537|"     The aims of this study are to investigate whether patient empowerment, including information     and decision-aids adapted to the risk and the need of the elderly patient, can improve     outcome in an evidence-based modular pathway in terms of        -  shortened hospital stay by a reduced postoperative complication rate and        -  quality of life in elderly patients compared to control patients receiving standard of          care.   "
153197|NCT01278524|"     An anonymous international multicenter - clinical survey, one-day observational study.   "
153198|NCT01278511|"     This study is designed to evaluate the safety, level of performance and level of comfort with     the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.   "
153201|NCT01278472|"     Laparoscopic Cholecystectomy (LC) is the treatment of choice for symptomatic gallstone     disease. Single-port access cholecystectomy (SL) has been recently introduced using only one,     trans-umbilical placed port. The method has been denominated as ''scarless.'' However, it is     unknown whether SL significantly improves body and cosmesis images as well as the quality of     life (QoL), reported directly by the patients. Furthermore SL promises to reduce     postoperative pain and to be cost-effective due a faster postoperative recovery.      The aim of this Double Blind Randomized Controlled Trial (RCT) is to demonstrate whether SL     is superior to LC in improving patients', body and cosmesis images as well as QoL and to     analyse cost-efficiency.      Based on the sample size calculations, a total of 110 patients will be randomised to either     LC or SL. The primary endpoint will be the cosmetic score. Costs, pain, time to     convalescence, quality of life and complications and will also be compared as secondary     endpoints.      This study will provide evidence-based patient-oriented information regarding the SL     procedure and its further use.   "
153202|NCT01278459|"     The purpose of the study is to test the hypothesis that a short course of atorvastatin can     improve vascular function in women with a history of preeclampsia, compared to placebo.   "
153203|NCT01278446|"     The primary objective of this clinical trial is to determine whether a new extensively     hydrolyzed infant formula is hypoallergenic.   "
153204|NCT01278433|"     The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in     China.      Objective:      To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at     2, 3, and 4 months of age among infants living in the study cities of China.   "
153205|NCT01278420|"     The purpose of this study is to compare the visual outcomes with bilateral implantation of     Tecnis MF and ReSTOR IOLs Six months post cataract surgery.   "
153206|NCT01278407|"     The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with     Lewy bodies (DLB).   "
153207|NCT01278394|"     The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in     the treatment of distal, subungual onychomycosis of the great target toenail.   "
153208|NCT01278381|"     Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative complications.     No score is currently available to help identify the patient's surgical risk. The purpose of     this study was to develop and validate a prognostic score to predict major postoperative     complications after PD.   "
153209|NCT01278368|"     No comparative trial investigating the effect of preoperative chemotherapy for locally     advanced pancreatic cancer on short-term postoperative outcome has been published so far. The     aim of the present study is to assess the potential impact of preoperative chemotherapy on     short-term postoperative outcome after pancreatic resection in a case-matched series of     cancer patients.   "
153210|NCT01278355|"     The purpose of this study is twofold: 1) to test the feasibility of integrating a simple     bilateral ear acupuncture procedure (Auricular Stimulation Procedure - ASP) into the standard     care delivered in the Aeromedical Evacuation system and 2) to observe and document any     changes in pain scores and in-flight related symptoms and factors (e.g. sinus block/pain, ear     block pain, nausea/air sickness) typically monitored during transportation of wounded     warriors from Ramstein Air Base (RAB) to Andrews Air Force Base (AAFB).   "
153211|NCT01278342|"     This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose     monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone     antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth     factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at     conventional regimen.   "
153212|NCT01278329|"     Auditory stimulation during pregnancy has been found to influence foetal behaviour with a     potential of being carried forward to neonatal period. This study evaluated the effect of     ante-natal music exposure to primigravida healthy mothers on the behaviour of their term     appropriate-for-date newborns. This was a single centre, randomized, open-label controlled     trial. Primigravida mothers aged 19-29 years, free of chronic medical diseases or significant     deafness, with singleton pregnancy, with a gestation of 20 weeks or less were randomized to     listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard     ante-natal care (intervention arm) or standard care only (control arm). Peri-natal factors     with adverse effect on neonatal behaviour were deemed as protocol violations. The infants     born to mothers exposed to music during pregnancy performed significantly better on 5 of the     7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation and     habituation.      Conclusion:      Music exposure to mother during pregnancy significantly influences neonatal behaviour.   "
153213|NCT01278316|"     This study is being conducted to understand whether training in tasks that require perceiving     and thinking about things, or cognition, can improve memory in veterans who have been exposed     to a blast explosion and have TBI and PTSD. A primary goal of the study is to determine     whether it is feasible for veterans who don't live close to a VA to perform this cognitive     training at home.   "
153246|NCT01277887|"     This is a pilot research study examining two types of behavioral counseling along with the     nicotine patch for smoking cessation. The study is designed to find out whether one of these     counseling interventions is more effective for smoking cessation among individuals with sleep     problems. The study has three parts: 1) an intake session; 2) a 10-week treatment phase, and     3) a 1-month follow-up.   "
153272|NCT01277549|"     The purpose of this protocol is to characterize the performance of CaridianBCT's Spectra     Optia Apheresis System, when used to collect mononuclear cells (MNCs) and cluster of     differentiation 34 (CD34) positive cells from healthy nonmobilized blood donors and healthy     G-CSF (granulocyte colony stimulating factor) mobilized blood donors, respectively.   "
153280|NCT01277445|"     Prebiotics are carbohydrate polymers believed to improve health by stimulating beneficial     gastrointestinal microbial populations. Prebiotic health claims are currently not permitted     in Canada due to a lack of validating scientific data. Currently, Health Canada considers     'prebiotic' to imply a health benefit that must be substantiated. Our goal is to conduct a     human clinical trial to define the impacts of fructans on the colonic microbiome as well as     the physiological, psychological and immunological effects on the host.   "
155659|NCT01246414|"     This study aims to compare the inflammatory mediators in exhaled breathe condensates from     allergic and non-allergic asthmatic patients.   "
153214|NCT01278303|"     Coarctation of the aorta (CoA) is a congenital abnormality producing obstruction to blood     flow through the aorta. Coarctation can occur in isolation, in association with bicuspid     aortic valve or with major cardiac malformations. CoA accounts for 5-8% of the 8/1000     (4-6/10,000) children born with congenital heart disease. Most CoA is newly diagnosed in     childhood; < 25% recognized beyond 10 yrs.      CoA is mostly repaired in childhood by surgery or by balloon catheter dilation. Recurrence     rates range from 5-20%. Recurrence is often not recognized until adolescence. Balloon     expandable stents have become the predominant therapy in the USA and Europe for CoA treatment     in this age group. There are no FDA approved stents for this use. Biliary stents are     currently being used off label. Enrollment into a trial of bare metal Cheatham Platinum (CP)     Stents, designed for use in CoA, is completed. The Coarctation of the Aorta Stent Trial     (COAST) aims to confirm safety and efficacy of CP Stent for native and recurrent CoA.      There are CoA patients with clinical situations that place them at high risk of aortic wall     injury during bare metal stenting. Extreme narrowing, genetic aortic wall weakness and     advanced age are examples. Patients may present with aortic wall injury (aneurysm) related to     prior CoA repair. The occurrence after surgical repair is 3-4% and after balloon dilation     10-20%. Repair of these aneurysms is surgically challenging. The use of fabric-covered CP     Stents to prevent or repair aortic wall injury has become the treatment of choice in Europe     and recently in the US through the FDA Compassionate Use process. There are no alternative     devices available in the US. COAST II will test safety and efficacy of Covered CP Stents to     repair or prevent aortic wall injury associated with CoA.      Funding Source-FDA OOPD   "
153215|NCT01278290|"     The aim of the study is to determine the specificity, sensitivity and diagnostic efficiency     of the Triptorelin Test in the assessment of CPP compared to GnRH test as gold standard.      Hypothesis: Aqueous Triptorelin Acetate is so efficient as GnRH to CPP assessment.      Study population are girls with suspicious clinical features of precocious puberty   "
153216|NCT01278277|"     The general area of research in which this project has been designed is that of retinal     degeneration related to mutations in the ABCR gene, responsible of Stargardt disease/fundus     flavimaculatus retinal dystrophy (STD/FF). STG/FF is one of the major causes of vision     impairment in the young age. STG/FF originates typically from the dysfunction and loss of     cone and rod photoreceptors, developing through a photo-oxidative mechanism. The major     disease locus is the central retina, i.e. the macula, whose neurons have the highest density     and underlie critical functions such as visual acuity, color vision and contrast sensitivity.     There is currently no cure for STG/FF. Recent experimental findings indicate that Saffron,     derived from the pistils of Crocus Sativus, may have a role as a retinal neuro-protectant     against oxidative damage. The stigmata of Crocus sativus contain biologically high     concentrations of chemical compounds including crocin, crocetin, whose multiple C=C bonds     provide the antioxidant potential. In addition it is well known that this compound is safe     and free of adverse side effects. The aim of this research is to investigate the influence of     short-term Saffron supplementation on retinal function in STG/FF patients carrying ABCR     mutations. The macular cone-mediated electroretinogram (ERG) in response to high-frequency     flicker (focal flicker ERG) will be employed as the main outcome variable. Secondary outcome     variable will be the psychophysical cone system recovery after bleaching.   "
153217|NCT01278264|"     Comparing morphine consumption and recovery with two different TAP block techniques after     abdominoplasty.   "
153218|NCT01278251|"     This study seeks to test the hypothesis that endobutton repair of the ruptured distal biceps     successfully restores elbow function.   "
153219|NCT01278238|"     The purpose of this study is to determine wether intravenous Phenylephrine, administered as     start bolus and following continuous infusion (specific dosage per weight), or optimal lower     limb bandaging is more effective in preventing hypotension during caesarean section under     spinal anaesthesia in healthy women.      The hypothesis is that the Phenylephrine model is superior to lower limb compression in     preventing hypotension.   "
153220|NCT01278225|"     The goal of this study is to learn if using a non-invasive therapy called neurofeedback     training can help teach patients ways to modify their own brain waves to decrease the     perception of pain and improve quality of life.   "
153221|NCT01278212|"     The goal of this study is to explore the safety, effectiveness, quality of life, and cost     effectiveness of accelerated hypofractionated radiotherapy (AHF-RT) as treatment after     lumpectomy in patients with early stage breast cancer.   "
153222|NCT01278199|"     Severe hemoptysis is a life-threatening condition, with an unpredictable course. The efficacy     of bronchial artery embolization (BAE) is well established for the treatment of severe     hemoptysis, with short and long-term bleeding controls obtained in 70 to 100% and 50 to 90%     of cases, respectively. As complications related to vascular interventional radiology may     occur in 5 to 10% of cases, the benefit-risk balance might be less clear in acute hemoptysis     of mild-to-moderate abundance (volume between 100 and 200 ml) and no criteria of severity     (respiratory failure or hemodynamic instability). There is no available data comparing the     safety and efficacy of BAE combined with medical measures to those of medical measures alone     in the treatment of non-severe acute hemoptysis of mild-to-moderate abundance.   "
153223|NCT01278186|"     This study in bifurcated coronary lesions compares the new technology of the     paclitaxel-eluting balloon with the usual technique until now of provisional stenting with     the paclitaxel-eluting stent in the main branch.   "
153224|NCT01278173|"     The purpose of the study is to evaluate the change in visual fields by means of automated     static perimetry and to evaluate the change in retinal structure by means of spectral domain     optical coherence tomography (SD-OCT) in adult patients with refractory complex partial     seizures (CPS) being treated with vigabatrin (Sabril®)   "
153225|NCT01278160|"     This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic     control of biphasic insulin aspart 30 twice daily with two different dosage split regimens     for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a     glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).   "
153257|NCT01277744|"     The goal of this clinical research study is to learn if heated intra-abdominal cisplatin can     help to control abdominal tumors in patients having surgery to remove the tumors. The safety     of this drug will also be studied.   "
174646|NCT00126373|"     The investigators are testing the hypothesis that Wellbutrin (bupropion) can give a clinical     remission in Crohn's disease.   "
153226|NCT01278147|"     The purpose of the present project is to develop, implement and evaluate a pilot regional     patient education program on the management of one of the main side effects of chemotherapy     in cancer patients, that is fatigue.      A carer (doctor or nurse) trained in educational techniques will be responsible for the     patient. The carer will first identify modes of behavior and competences that the patient     must acquire in order to optimize his/her management of fatigue (educational diagnosis). An     education program, based on a contract of goals will be proposed after this diagnosis phase.     The expected results are, in the short-term, a significant reduction in the mean level of     fatigue in patients receiving chemotherapy who benefited from individual educational     management. In the longer term, the aim is to evaluate the impact of this program on patient     quality of life and use of healthcare structures in comparison with conventional management.   "
153227|NCT01278134|"     This multicenter, randomized, double-blind, parallel group study will evaluate the safety and     efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without     Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B,     interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100     mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200     mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm     patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop     all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week     follow-up.      As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in     conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg     subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a     24-week follow-up.   "
153228|NCT01278121|"     One of today's major health problem in the western world is related to lifestyle. Lifestyle     diseases include obesity, type 2 diabetes, cardiovascular diseases and different types of     cancers. For many years, a low-fat diet has been recommended to reduce obesity and lifestyle     diseases, but replacing fat with carbohydrates has lead to an increase of these diseases.     Overweight is associated with a chronical low-degree inflammation, and later studies have     shown that carbohydrates have an effect on the mechanisms of inflammation. Previous studies     in the investigators group has shown that in healthy, but slightly overweight persons, a     balanced diet of lower carbohydrate content regulates the gene expression in a manner that     leads to less inflammation. In this study the investigators will look at morbid obese women     (BMI>35) to see if the same, balanced diet can improve the inflammatory profile of the women.   "
153229|NCT01278108|"     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)     and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food).      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple     oral administration will be evaluated, and, if applicable, the maximum tolerated dose     determined.   "
153230|NCT01278095|"     The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of     GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of     GLPG0555.   "
153231|NCT01278082|"     This study aims to demonstrate the superiority of budesonide compared to placebo as     maintenance therapy in keeping patients in remission over a one-year period   "
153232|NCT01278069|"     Myeloid Sarcoma (or granulocytic Sarcoma or Chloroma) is well defined by the WHO. However,     there are currently no data about the prevalence, sites of occurence and thr prognostic value     for patients with AML with this finding. Information about this condition is based on     retrospective analyses since there have been no studies trying to define the role of myeloid     sarcoma in AML so far. This observational trial will include adult patients with newly     diagnosed and relapsed AML in order to perform 18FDG-PET-CT imaging prior to induction     chemotherapy. Furthermore, a second 18FDG-PET-CT will be performed after induction     chemotherapy to define the responsiveness of these tumors to chemotherapy. The primary     endpoint of this study is the prevalence of 18FDG-PET-CT positive extramedullary AML     manifestations (myeloid sarcoma) in patients with newly diagnosed or relapsed AML.   "
153233|NCT01278056|"     This is a Phase I/II open-label uncontrolled, prospective study to assess the clinical and     biological effects of Deferasirox (ICL 670, Exjade®) in patients with NASH and increased iron     storage / distribution of iron on liver function and liver histology.      NASH is defined clinically and histologically by elevated liver enzymes, signs of hepatic     steatosis on ultrasound and magnetic resonance imaging, impaired liver function as expressed     by functional breath tests, and significantly altered liver histology.      Patients will be treated in a phase I and phase II part for either 12 or 48 weeks.      Both study parts have different endpoints: in phase I the side effect profile will be     evaluated while in phase II the therapeutic response will be tested. Accordingly, measures     will be different.      Approximately 10 patients in phase I and 50 patients in phase II will be enrolled according     to sample size calculations.      The design is an adaptive Two-stage design, allowing to minimize the number of patients     included into the trial as well as to introduce corrections for the second stage.   "
153244|NCT01277913|"     The aim of the study is to assess the effect of 12 month supplementation with two different     doses of vitamin D ( 500 vs 1000) on bone mineral density, serum 25 hydroxyvitamin D levels     and hand grip strength in preadolescents with diabetes mellitus type 1.      100 children in the of age 8 -11 with diabetes mellitus type 1 lasting for more than 3     months, without history of diabetic ketoacidosis during previous month, without other chronic     disease which may affect calcium-phosphorus metabolism will be randomized in a double blind     controlled trial to supplement them with either 500 IU or 1000 IU vitamin D. Every 3 months,     in spring summer,autumn and winter serum level of calcium,25-hydroxyvitamin D level and HbA1c     will be measured. At the entry and at the end of the study patients will have total body and     lumbar spine bone mineral density assessment. Every six months hand grip strength will be     measured. Additionally at the beginning and after 12 mo of supplementation and at the     beginning serum levels of TNF-alfa, osteoprotegerin and IL-6 will be assessed.   "
153271|NCT01277562|"     The investigators hypothesis is that secondary causes of bone loss are prevalent in patients     with breast and prostate cancer, and those patients with secondary causes of bone loss are at     higher risk for treatment related bone loss. The goals of this pilot study are to estimate     the prevalence of secondary causes of osteoporosis in a cohort of patients with nonmetastatic     breast and prostate cancer with osteopenia and osteoporosis.   "
153234|NCT01278043|"     Subjects in this study have recently had or are scheduled for a percutaneous coronary     intervention (PCI) as part of their normal, routine medical care. This procedure should     restore the blood flow in the vessels of the heart.      One complication that can occur after a PCI procedure is blood clotting and narrowing of the     artery in the area that was treated. This can result in a decrease in the blood flow to the     heart. To avoid this complication, patients are given antiplatelet or blood-thinning drugs     such as aspirin and clopidogrel as part of their routine care after this procedure.      For this research study, the investigators would like to take blood samples from subjects at     3 different time points while they are taking these antiplatelet drugs. The investigators     will study the subjects' blood and medical history to help us further our understanding of     how these drugs respond in individuals and in certain patient populations. Everyone responds     a little differently to medications due to many reasons including our genetic make-up. Genes     are passed down from our parents and determine our physical appearance such as the color of     our hair and eyes. Differences in our genes may also help explain why some drugs work in some     people, but not in others. By studying subjects' blood, medical history, genetic make-up and     by recording how the subjects' blood responds over the course of their treatment, the     investigators hope to learn more about how our bodies respond when taking these drugs.     Additionally, the investigators hope to find better ways to predict who will respond more     effectively to these drugs and better ways to monitor how these drugs are working in     patients' bodies over time after PCI procedures.   "
153235|NCT01278030|"     The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT)     responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead     placement compared to traditional LV lead placement.   "
153236|NCT01278017|"     The purpose of the investigators study is to evaluate if short-course of ceftriaxone therapy     could shorten the clinical courses of severe nontyphoidal Salmonella enterocolitis in     children and the excretion of Salmonella in feces.   "
153237|NCT01278004|"     This study is a drug trial of ethosuximide as a painkiller if you develop pain as a side     effect of chemotherapy. Ethosuximide will be compared against placebo (an inactive substance)     to test whether any response is a true effect of the drug, and not a 'placebo effect'.   "
153238|NCT01277991|"     In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate     occasions using one of two different strength tablets each time. The amount of CP-690,550     available in the blood following administration of each tablet will be measured and compared.     The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed     into the blood following administration of the same dose of each different strength tablet .   "
153239|NCT01277978|"     The purpose of this study is to evaluate the immediate effects of carbetocin and oxytocin on     maternal hemodynamic parameters (heart rate and blood pressure) in a non-invasive setup     (TaskeForce®-Monitor) during primary Caesarean section.   "
153240|NCT01277965|"     Primary aim:      To show that in subjects with type 1 diabetes with a subcutaneous continuous insulin     infusion, adjustment of the recommended basal insulin flow rate in the event of physical     activity allows the subjects to practice sports without any increase in incidence of     hypoglycaemia during physical activity or the ensuing hours.      (NB: hypoglycaemia is defined as blood glucose less than 3 mmol/l or 0,54 g/l in accordance     with the EMEA definition).      The proposed algorithms consist of a temporary reduction in basal flow of 50 percent or 80     percent (temporary basal flow TBR50 or TBR80) depending on the intensity of physical activity     (50 percent of VO2max or 75 percent of VO2max). Switching off the pump will also be studied     as an option to adjust insulin dosage in the event of unprogrammed physical activity     (temporary reduction of basal flow by 100 percent).      Secondary aims:        -  Characterisation of hypoglycaemia during and after physical activity based on CGMS data:          symptomatic or non-symptomatic nature of hypoglycaemia, time to onset of hypoglycaemia          in relation to the start of physical activity, degree and severity of hypoglycaemia.        -  Evaluation of overall variations in blood glucose in the event of physical activity          using CGMS data (area under the curve).        -  Evaluation of glucose restoration methods used in the event of hypoglycaemia.        -  Analysis of subgroups of patients with and without hypoglycaemia.   "
153241|NCT01277952|"     The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe     disability due to Traumatic Brain Injury.   "
153242|NCT01277939|"     This study will evaluate the comparative effectiveness of Therapeutic Education System (TES),     a computer-based, psychosocial treatment program, relative to standard care when offered to     individuals with substance use disorders in prison settings. The study will assess the     comparative effectiveness of these interventions primarily by examining changes in: (1)     substance use (e.g., weeks of abstinence), (2) HIV risk behavior (evaluated as both     sex-related and drug-related HIV risk behavior) and (3) reincarceration rates. The study will     also examine the extent to which these interventions improve psychosocial functioning (e.g.,     employment, health, and psychological status) and quality of life, and promote relevant     skills acquisition (e.g., improve communication skills, reduce criminal thinking). The     investigators predict significantly better outcomes for E vs. C due to TES' research-based     content and use of proven informational technologies.   "
153243|NCT01277926|"     The purpose of this study is to characterize the current patterns of care for patients with     hormone-receptor-positive, advanced breast cancer who have failed one prior endocrine therapy     in Brazil. To investigate patient-related, disease-related and physician-related     characteristics that correlate with the use of either endocrine treatment or chemotherapy in     such patients. And to evaluate patients' understanding of the treatment options and their     participation in the choice.   "
153245|NCT01277900|"     Type 2 diabetes mellitus (T2DM) resolution in morbidly obese patients following bariatric     surgery suggests the efficacy of metabolic surgery in non-morbidly obese patients (body mass     index [BMI]<35 kg/m2). Many researches have shown available evidence about the efficacy and     safety of metabolic surgery for resolution of T2DM in the non-morbidly obese. One of the most     effective metabolic surgeries is laparoscopic Roux-en-Y gastric bypass (LRYGB). The     investigators intend to run a 3 year prospective multicenter study to evaluate the remission     efficacy of laparoscopic Roux-en-Y gastric bypass in Type 2 Diabetes mellitus with low BMI     (BMI:25-35) in Asia area.   "
178942|NCT00183638|"     This study will develop and evaluate the effectiveness of tailored web-based messages in     promoting condom use among young adults.   "
153247|NCT01277874|"     This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP)     respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or     non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if     Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP without     oscillations. This will be measured by need for change to ventilator support, improvement in     pCO2 values, and reduction in respiratory rate and frequency of apnea during the period of     NCPAP treatment. Other respiratory outcomes will also be compared, including time on NCPAP,     time on High-Flow Nasal Cannula support following NCPAP, and time-averaged PiO2 from start of     study to end of respiratory treatment.   "
153248|NCT01277861|"     The investigators plan to test the hypothesis that pretreatment with fentanyl prior to     induction of anesthesia would result in reduce the incidence of movements and airway     responses to desflurane in patients breathing spontaneously through a laryngeal mask airway     (LMA). The primary aim of this study is to assess the effect of fentanyl pretreatment on the     incidence of movement during induction of anesthesia. Secondary aim of the study is to     evaluate the effects of titration of fentanyl according to the respiratory rate on the     incidence of intraoperative respiratory events such as coughing, breath holding and     laryngospasm.   "
153249|NCT01277848|"     The PLAC1 gene is a recently described X-linked gene that maps to a region of the X     chromosome thought to be important for normal fetal and placental development. Elevated     levels of PLAC1 mRNA were detected in preeclampsia and appeared to be directly related to     disease severity. PLAC1 may serve as a useful marker of placental dysfunction or threatened     pregnancy.      The objective of this study is to measure the prevalence of circulating anti-PLAC1 antibodies     in pregnant maternal serum and correlate it with pregnancy outcome. It is likely that women     with these antibodies are at higher risk for adverse pregnancy outcomes. Approximately 5% (50     of 1000) will be expected to have anti-PLAC1 antibodies based on previously reported data.     The prevalence of these antibodies and their clinical impact on pregnancy outcomes will be     determined.      1000 healthy, multiparous and primigravid women will be screened for anti-PLAC1 antibodies at     their routine prenatal clinic visits. Subjects will be enrolled at their first clinic visit     at USF Health, South Tampa Center, Department of Obstetrics. Blood (1.0 ml) will be obtained     as part of the routine blood draw at the time of enrollment. Blood will only be collected     when drawn as part of routine laboratory testing as determined by the primary care provider.      Additional blood samples (1.0 ml) will be collected throughout pregnancy at the same time     blood is obtained for routine or otherwise clinically indicated laboratory testing. A maximum     of 5 samples will be collected through the pregnancy.      Maternal demographic data will be collected and patients will be followed longitudinally to     the completion of pregnancy to ascertain their clinical status during pregnancy, onset of     premature labor, premature rupture of membranes, delivery date, and gestational age at     delivery.   "
153250|NCT01277835|"     The purpose of this study is to determine whether intravenous lidocaine infusion during a     video-assisted chest surgery is effective in reducing the pain involved after the surgery.     The hypothesis is that continuous lidocaine infusion during video-assisted thoracoscopic     surgery (VATS) reduces morphine consumption and postoperative pain.   "
153251|NCT01277822|"     This study will determine whether using losartan and amlodipine together will be non-inferior     in lowering blood pressure than amlodipine alone.   "
153252|NCT01277809|"     The purpose of this study is to assess the effectiveness of a regular walking program (which     inevitably involves human interaction) compared to a usual care condition and to a human     interaction condition (without the extra walking program) in individuals residing in     Long-Term Care (LTC). Outcomes of interest include: balance, strength, mobility, endurance,     walking distance; rate and severity of falls; activities of daily living; mood and behaviour.      It is hypothesized that participants taking part in the walking program will demonstrate     maximal benefits compared to the no treatment control group (usual care) and the participants     who will only receive social interaction. It is expected that benefits of the walking program     will include decreased fall rates, and improved balance, endurance, strength, mood,     behaviour, activities of daily living and quality of life indices. Given research findings     that the addition of pleasant activities improves resident mood (Teri et al, 1997; 2003), it     is expected that participants in the social interaction only group will demonstrate     improvements in mood and other indices of quality of life.   "
153253|NCT01277796|"     Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are     expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable.     Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous     Leishmaniasis in South America. However, current heat-delivery modalities are either too     costly or lack governmental approval required to be made widely available to endemic areas.     The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous     Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the     investigators will enroll 25 patients who have either failed or are not candidates for     pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy     non-statistically inferior to estimates for current South American Pentavalent Antimonial     cure rates (76%) while demonstrating basic safety and tolerability.   "
153254|NCT01277783|"     The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective,     non-randomized, multi-national clinical investigation.      The purpose of this clinical investigation is to evaluate the safety and performance of the     investigational atrial transseptal endocardial LV lead delivery system and the implant     procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a     superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in     the Left Ventricle.   "
153255|NCT01277770|"     The purpose of this study is to improve outcome for kidney transplant recipients. There has     not been commensurate improvement in medium and long-term outcomes. Ongoing clinical research     is necessary to improve transplant outcomes.   "
153256|NCT01277757|"     This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with     breast cancer cancer that has spread to other places in the body and usually cannot be cured     or controlled with treatment. Akt inhibitor MK2206 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
179153|NCT00180050|"     The purpose of this study is to determine whether orale budesonide is effective in the     treatment of lymphocytic colitis   "
153258|NCT01277731|"     Dexamethasone is a potent synthetic member of the corticosteroid. It is given to cancer     patients undergoing chemotherapy to counteract emetic side effect and essential drug for the     chemotherapy-treated patients. Hiccup is common adverse effect of corticosteroid especially     on dexamethasone varying from 3% to 60% of given patients. Discontinuance of dexamethasone     relieves most hiccupping cases, but vomiting/nausea rates increase. It is not clear whether     hiccup side effect is limited to the dexamethasone only or other corticosteroid group.      Methylprednisolone, synthetic corticosteroid as similar as dexamethasone, could be considered     as antiemetic agent for the patients with receiving chemotherapy. The investigators perform     this pilot study under hypothesis that replacing dexamethasone with methylprednisolone could     maintain antiemetic role and prevent hiccup.   "
153259|NCT01277718|"     This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover     study of cobimetinib in healthy participants to evaluate the effect of the proton-pump     inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy     participants when administered in the fed or fasted states.   "
153260|NCT01277705|"     This study will assess the immunogenicity and reactogenicity of the candidate GSK     Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis-     inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in     Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine     administered separately, and with Revaxis®   "
153261|NCT01277692|"     This study is a three Part, Phase 1, randomized, dose-escalation, fusion, placebo-controlled,     double-blind study to determine the safety, tolerability and Pharmacokinetic (PK) profile of     GSK2336805 in healthy subjects and the safety, tolerability, PK, and antiviral profile of     GSK2336805 in subjects chronically infected with HCV: i. Single doses in healthy subjects and     the effect of food on GSK2336805 PK (Part 1). ii. Repeat doses in healthy subjects (Part 2)     iii. Single doses in chronically infected HCV positive subjects (Part 3).   "
153262|NCT01277679|"     The aim of this study is to establish a model for the evaluation of drug targets using     postural measures to induce changes in lung water concentration as assessed by MRI. A     reduction in the magnitude and rate of water transudation with postural changes in patients     with congestive heart failure (CHF) could provide a model for the evaluation of various     classes of molecules for target validation and for dose selection.   "
153263|NCT01277666|"     This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and     safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A as compared to     placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease.     Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease     in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response).     Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary     endpoint. Safety will be assessed by recording of adverse events, clinical laboratory     parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will     evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in     Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and     Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.   "
153264|NCT01277653|"     There is no prospective study on the test intervals of alpha-fetoprotein (AFP) or on the role     of prothrombin induced vitamin K absence or antagonist-II (PIVKA-II) in surveillance program     for early detection of hepatocellular carcinoma(HCC). The goal of this study is to compare if     the testing of AFP + PIVKA-II in intervals of 3 months is more effective in diagnosing early     stages of HCC than the 6 month interval of AFP that is commonly used   "
153265|NCT01277640|"     The purpose of this study is to determine the safety of male genitalia when exposed to     dapivirine gel following seven once daily applications.   "
153266|NCT01277627|"     Nevirapine-based antiretroviral therapy is associated with lower plasma HCV viral load in     HIV/HCV-coinfected individuals.   "
153267|NCT01277614|"     The investigators previously established that there was a high burden of disease among all     categories of staff at the University of the West Indies, St. Augustine and in many ways,     this group is typical of the working class of the Caribbean population. Many had poor     lifestyle behaviors, 23.8% had Metabolic Syndrome (MS) with many having one or more MS     components. Since most time is spent at work, the workplace is understandably the most     logical location to address issues pertaining to health, disease prevention and wellness and     on-site programs have yielded many health and other benefits to employees and employers     alike. Onwards of the 1980s, numerous studies have been done on work-site intervention     programs and these have shown that if a company is able to identify employees at risk for     developing health problems and then intervene, health risks and the resulting medical     problems are reduced. Such a program, if tailored to meet the needs of participants, may     yield similar benefits among the staff of the University of the West Indies.   "
153268|NCT01277601|"     The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil     fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus     standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults     with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen     (HBsAg).      The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks     + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment,     participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and     those meeting TDF retreatment and flare management criteria will be eligible to receive TDF     monotherapy during a retreatment phase, up to Week 120.   "
153269|NCT01277588|"     During labor, fetal scalp sampling is performed if the CTG registration is abnormal. The test     is performed with the woman in the supine position and is generally described as a difficult     and cumbersome procedure.   "
153270|NCT01277575|"     The investigators assess if repetitive, transcranial alternating current stimulation (rtACS)     can improve the speaking quality of the aphasic patient as well as other communication skills     as naming, repeating and understanding spoken words, reading and writing. Further, it will be     assessed if memory and attentiveness deficiencies after 10 days of therapy with brain     stimulation are stabilized and remain stable after a training-free period of 60 days.   "
179154|NCT00180063|"     Characterization of an unexpected venodilative effect of higher L-NMMA-doses in dorsal human     hand veins.   "
153273|NCT01277536|"     Until now, no risk assessment model informing about the need of thromboprophylaxis in     patients admitted for an acute medical event has been validated.      The goal of this project is to indirectly validate a model developed in Geneva by a non     -interventional study involving the collection of patient characteristics during the     hospitalization and a 3-month follow-up. These data will allow for the determination of the     patient's risk, according to the Geneva model, and its validity, according the actual     thrombo-embolic events, corrected for the thromboprophylaxis received.      The project is multicentric in Switzerland (5-10 centers) and should involve about 1000     patients.      First amendment (may 2011) : we have obtained the IRB approval for collecting data from     patients who die during their hospital stay and for whom informed consent is not be possible     to obtain.   "
153274|NCT01277523|"     The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation     solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks,     compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to     17 years old) with severe persistent asthma.      The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and     possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary     function endpoint after 12 weeks of treatment.      Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints,     and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy     on top of usual care in this patient population.   "
153275|NCT01277510|"     The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the     current treatment of secondary hyperparathyroidism in children currently receiving dialysis     compared to a treatment regimen that does not include cinacalcet.   "
153276|NCT01277497|"     Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast     growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart     disease. As kidney function declines, less phosphorus is removed by the kidneys and as a     result phosphorus accumulates in the blood. In response to elevated phosphorus levels, more     FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine. In     addition to effects on FGF-23, increased phosphorus levels can lead to calcification     (hardening) of the blood vessels in the CKD population.      Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus     absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD,     studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering     FGF-23 levels in CKD patients may also lower substances in the blood that cause calcification     of blood vessels in the CKD population.      This study is being done to determine if using phosphate binders, either sevelamer carbonate     or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease     FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood     vessels and heart disease.   "
153277|NCT01277484|"     Brief Scientific Rationale:      Decitabine has been shown to be effective for treatment of MDS and associated with very     limited extramedullary toxicity at the lower doses. Furthermore, the hypomethylating effects     of decitabine require an extended period of therapy and are likely to be more beneficial in     the setting of a minimal residual disease after transplantation. The drug might exert a     cytoreductive effect on the MDS clone, but ex vivo expansion strategy using decitabine and     HDAC inhibitor provides a potential to expand the number of hematopoietic stem cells. There     are lots of evidence which showed the the drug have immunostimulatory effects and can be used     to enhance graft-versus leukemia effects. And also, some investigator suggested that     decitabine could induce FOXP3 expression, promoting the conversion of naïve T cells to Tregs     which are known to suppress GVHD while maintaining GVL effect in allo-SCT setting. As such,     decitabine is an ideal agent to be investigated in the post-transplant setting.      The investigators hypothesized that post-transplant maintenance therapy with decitabine may     reduce relapse rate, which may maximize the beneficial effects from reduced TRM of     ATG-containing FB4 or FB2 conditioning regimen in higher-risk MDS or AML evolving from MDS     patients.   "
153278|NCT01277471|"     Aims and priorities of the project The purpose of this study is to        1. test the effect of frequency of meals (six vs. two meals daily with the same daily          caloric restriction of -500 kcal/day) on insulin sensitivity, insulin secretion, and          hepatic fat content.        2. characterize some of the mechanisms of action of different frequencies of meals (amount          of visceral fat, hepatic fat content, serum concentrations of adipokines, gut hormones,          oxidation stress markers).        3. test the ability of the participants to maintain hypocaloric diet on both regimens when          educated and left to prepare their meals alone in comparison with those for whom all          meals during the study will be provided.      It will be a randomized, crossover study, where 50 individuals with type 2 diabetes will     change in a random order two regimens: six, and two meals a day. Each testing period will     take three months.      Glucose and lipid metabolism and its regulation will be thoroughly tested at start, and after     each 3-months-period (meal test, hyperinsulinemic isoglycemic clamp, indirect calorimetry,     MRI scan of the liver, DXA scan, serum concentration determination of selected adipokines,     gut hormones, and oxidation stress markers).      Hypothesis The investigators hypothesize that low plasma insulin levels (as achieved by     periods of fasting) will reduce insulin resistance and hepatic lipid content. In contrast,     frequent meals (and consequent higher plasma levels of insulin) will predispose to     non-alcoholic fatty liver disease and insulin resistance. The investigators further     hypothesize that the participants will increase their caloric intake with increased meal     frequency (in spite of thorough education) when left to prepare their meals in comparison     with those for whom all meals will be provided.   "
153279|NCT01277458|"     Are there differences between the way that non-White men who have sex with men living in     London with HIV describe their own ethnicity and the way in which their ethnic group is     recorded in NHS clinics? We aim to describe the way in which clinics in London currently     record a patient's ethnic group. Without accurate data for an individual's ethnic group we     are unable to draw meaningful conclusions about their experiences of HIV care. It may be the     case that patients from particular ethnic groups require specific ways of monitoring and     treating their HIV but without knowing if these people are in a particular group any services     directed to them may be wasted or underused.   "
165069|NCT00005472|"     To analyze the association between an objective measure of job strain and risk of stroke,     and change in ambulatory blood pressure.   "
153281|NCT01277432|"     The investigators aim to:        1. Estimate the prevalence of depression in a consecutive cohort of Chinese patients          diagnosed with Type 2 Diabetes (T2D) living in areas of China with different          socioeconomical affluence        2. Examine patients' awareness of the frequent coexistence of these 2 conditions        3. Analyze the associations between depression and T2D, in particularly the role of          metabolic control, socioeconomical status and cognitive-psychological-behavioral factors        4. To document the predisposing, precipitating and perpetuating factors for depression and          their interrelationships in Chinese type 2 diabetic patients   "
153282|NCT01277419|"     The German Spondyloarthritis Inception cohort (GESPIC) was started as a prospective,     longitudinal, multicentre, nationwide study in Germany on patients with early SpA including     ankylosing spondylitis and non-radiographic axial SpA. The objectives of GESPIC are to learn     about the course of AS and other SpA during the very early stage of the disease, to     appropriately assess the outcome including radiographic progression of patients after several     years of follow-up, to identify outcome predictors, to assess quality of life, function, and     costs (direct and indirect costs).   "
153283|NCT01277406|"     The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of 4SC-201     (Resminostat) in combination with FOLFIRI and whether 4SC-201 (Resminostat) is effective and     safe in combination FOLFIRI versus FOLFIRI alone in the treatment of advanced colorectal     carcinoma.   "
153284|NCT01277393|"     This study is to find out care of critically ill patients enteral nutrition guidelines for     the implementation of the effectiveness of the intervention.   "
153285|NCT01277380|"     The first outbreak of a new H1N1 influenza pandemic originated in the North America in April     2009. As of July 1, 2009, a total of 77,201 cases were accumulated in 103 countries around     the world and the mortality rate of was about 0.43%. Alignment and analysis on gene sequences     of the new H1N1 influenza virus found that it contains extremely homologous gene composition     with that of the swine influenza viruses (swine flu) identified in Europe and North America     in last century. Thus the virus strain was later renamed as a novel influenza H1N1. In     general, the symptoms caused by the new influenza H1N1 infection was very similar to those     resulted from seasonal influenza viral infection. Thus, it is difficult to distinguish the     various influenza strains responsible for the infections only by clinical appearance. To     compare the accuracy, specificity and sensitivity and speed in identifying the new influenza     H1N1 in suspected cases, the investigators extracted RNA from influenza A-positive reactive     specimens identified by a Influenza Rapid Test, for a Real-time PCR method to further detect     the presence of swine H1 gene. In addition, the titer of H1N1 virus, the color development on     the test stripe and clinical symptoms in patients were significantly associated. Finally,     Real-time PCR products were subjected to sequence determination to explore potential new     influenza pathogenicity, transmissibility and drug usage.   "
153286|NCT01277367|"     The aim of the study is to prospectively compare the effectiveness of diverse incentives on     physical activity behaviour, in a cohort of newly-enrolled, adult members of the Vitality     health promotion programme based in South Africa.   "
153287|NCT01277354|"     The purpose of this study is to examine the effects of experiencing a previous pregnancy loss     or complication on current physiological and emotional aspects of a current pregnancy.   "
153288|NCT01277341|"     This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.   "
153289|NCT01277328|"     This observational, prospective, open-label, multi-center study will evaluate the     effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in     patients with rheumatoid arthritis. Data will be collected for 11 months.   "
153290|NCT01277315|"     Amyotrophic Lateral Sclerosis (ALS) is an adult neurodegenerative disease that is caused by a     selective degeneration of the motor nerve cells in the cortex and myelon. As a result of     motor neurodegeneration, a progredient paralysis of the extremities and of the speaking,     swallowing, and breathing musculature develops. ALS leads to death by respiratory     insufficiency in a mean course of 3-5 years. So far, Riluzole is the only approved     neuroprotective medication which effects a slight lifespan prolongation of 1.5 - 2.5 months.     Riluzole inhibits the presynaptic glutamate release and lowers the level of glutamate     liberated by activated microglia.      The researchers propose an investigational therapy of ALS with subcutaneous administration of     100 mg of Anakinra. The neuronal inflammation is a crucial pathogenetic factor of the motor     neuron degeneration. Inflammatory processes are detectable in sporadic ALS, in the     autosomal-dominant form of ALS and in transgenic mouse model. The rationale of this clinical     trial is based on the anti-inflammatory effect of Anakinra. One of the key mediators of     inflammatory response is Interleukin-1. Anakinra is a recombinant produced Interleukin-1     receptor antagonist. This gives Anakinra anti-inflammatory attributes that presumably reduce     motor neuron degeneration and disease progression.   "
153291|NCT01277302|"     This was a Phase IV multicenter, randomized, open-label study, with masking of the vision     examiner, of the efficacy and safety of intravitreal ranibizumab 0.5 mg in subjects with     macular edema following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein     Occlusion (CRVO).   "
153292|NCT01277289|"     The aim of this study is the assessment of the efficacy of Ery-Dex (dexamethasone     intra-erythrocyte) versus placebo in maintaining patients with steroid-dependent Crohn's     disease in clinical remission throughout 12 months without oral steroids.   "
153306|NCT01277107|"     This is a multi center, double blind placebo controlled, two-way crossover study in patients     with Insomnia suffering from difficulty in falling asleep and staying asleep. This study     intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to     placebo.   "
153507|NCT01274494|"     The aim of this multi-centre survey is to assess treatment adherence and quality of life in a     Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled     essential hypertension being on antihypertensive treatment for at least 6 months.   "
153308|NCT01277081|"     The aim of this study is to subjectively assess symptoms in subjects suffering from the     common cold following a single dose of paracetamol hot drink compared to paracetamol tablet   "
153535|NCT01274130|"     This is the investigatory study to find out metformin's pharmacokinetics, pharmacodynamics     and drug-drug interactions classifying the group by MATE1 genotype in healthy volunteers. The     investigators will apply ranitidine and verapamil to the drug interaction study of metformin.   "
153293|NCT01277276|"     Currently there is no methodology that can assign a risk of development of chemo brain and     thus, studies to understand how and why only some patients develop chemo brain along with     studies of potential treatments face major hurdles. This study will define     hemodynamic/optical parameters in normal individuals and cancer patients undergoing     chemotherapy potentially identifying optical parameters that are associated with the     development of chemo brain, leading to new insights into the origin of the chemo brain     condition, and importantly potentially identifying parameters that may predict who will     develop chemo brain in order to directing investigations of therapies.   "
153295|NCT01277250|"     This project, Web-based Smoking Cessation Intervention: transition from inpatient to     outpatient, addresses smoking among hospitalized patients, whose rates are higher than among     the general population. Hospitalization offers a unique opportunity to intervene, as it     requires temporary abstinence and patients are focused on health concerns. Hypotheses: A     tailored web-based and e-message smoking cessation program for current smokers that, upon     hospital discharge, transitions the patient to continue a quit attempt when home will be     effective. Further, the investigators hypothesize that this approach will be cost-effective.     Specific Aims: 1. To test the effectiveness of a web-based smoking cessation intervention. 2.     To determine the cost-effectiveness of this approach. Research Design - Methods: A randomized     two-arm follow-up design will be used to test the effectiveness of an evidence- and     theoretically-based smoking cessation program designed for post-hospitalization. Patients     randomized to this arm will be contacted by hospital staff, trained as 'transition coaches,'     to engage in Decide2Quit, an interactive web-based program that offers personalized and     tailored messages, e-group support, and text messages promoting tobacco abstinence. All     hospitalized patients will receive standardized smoking cessation materials. As well,     physicians can order nicotine replacement therapy via the hospital's electronic order system.     The investigators primary outcome is biologically confirmed and self-reported tobacco     abstinence at 6 months follow-up; the investigators will also assess self-reported quit rates     at 3 and 12 months and variables hypothesized to predict quit success. We will measure health     care utilization and quality of life to allow testing the cost-effectiveness of this program     conducted from the perspective of a hospital, health care payers, patients and society.     Significance of results: At study completion the investigators will know whether imbedding     smoking cessation into usual hospital care, with minimal hospital-staff burden, and an     interactive web-based tailored intervention program is an effective way to reduce smoking     rates among hospitalized patients, and if it is cost-effective. This program will be an off     the shelf approach that could be disseminated easily.   "
153296|NCT01277237|"     There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces     the amount of fat stored in the liver and improves liver function. The purpose of this study     is to see whether this observation is correct.   "
153297|NCT01277224|"     The purpose of this study is to evaluate the effectiveness of a recreational physical     activity intervention (RPAI) for reducing the prevalence of overweight/obesity and other     cardiovascular risk factors   "
153298|NCT01277211|"     This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of     pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be     assessed and compared with that of Yasmin.   "
153299|NCT01277198|"     Authors want to investigate the usefulness of flexible cystoscopy in performing laparoscopic     pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's     experience.   "
153300|NCT01277185|"     The purpose of this study is to identify calcium metabolism characteristics in Mexican     American adolescents. The investigators predict that calcium requirements to maximize bone     health in this population will be lower than for white youth but higher than their current     intakes.   "
153301|NCT01277172|"     This is a prospective international, multi-center, randomized, double-blind controlled study     designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of     PBO-326 (Rituximab) and Mabthera (Rituximab) in combination with CHOP in previously untreated     patients with diffuse B cells Non Hodgkin lymphoma.   "
153302|NCT01277159|"     Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve     block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa     nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg     2008;106:1916-20), but unfortunately the patients still often experience moderate to severe     pain after the block wears off. The investigators wish to study two additives that may     prolong the period of analgesia provided by the nerve block. The additives will be studied in     the context of a standardized postoperative multimodal analgesic pathway.      Primary outcome:      Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a     popliteal fossa nerve block?   "
153303|NCT01277146|"     This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously     treated solid tumors for which there is no remaining standard curative therapy and no therapy     with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers.     Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and     efficacy. No formal interim analyses will be performed.      Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon     enrollment, subjects will receive intravenous (IV) infusions of OMP-59R5 at a assigned dosing     schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there     is no evidence of disease progression or if the tumor is smaller, then subjects may continue     to receive IV infusions of OMP-59R5 every week until disease progression.      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose     escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled     in a cohort will not be treated on the same day. The dose may be administered at any time     during the day. Three subjects will be treated at each dose level if no dose-limiting     toxicities (DLTs) are observed. The first 2 subjects in each cohort will not be started on     OMP-59R5 on the same day. If 1 of 3 subjects experiences a DLT, that dose level will be     expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be     dosed at that level and 3 additional subjects will be added to the preceding dose cohort     unless 6 subjects have already been treated at that dose level. Subjects will be assessed for     DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled     subjects, if appropriate, will occur after all subjects in a cohort have completed their Day     28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to     continue to receive weekly doses of OMP-59R5 until disease progression. An additional 14     subjects will be enrolled at the highest dose level that result in <2 of the 6 subjects     experiencing a DLT.   "
153304|NCT01277133|"     This single arm, prospective, observational study will assess the correlation between the     time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with     progression-free survival in patients with previously untreated metastatic breast cancer.     Patients will be followed for up to 12 months after progressive disease occurs.   "
153305|NCT01277120|"     This single arm, prospective, observational study will assess the correlation between the     time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with     progression-free survival in patients with previously untreated metastatic colorectal cancer.     Patients will be followed for up to 12 months after progressive disease occurs.   "
167933|NCT00037687|"     The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all     cause mortality in patients with severe sepsis.   "
153307|NCT01277094|"     This multi-center, double-blind, randomized, placebo-controlled study will evaluate the     change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with     non-alcoholic fatty liver disease. Patients will be randomized to receive either daily oral     doses of RO5093151 or matching placebo. The anticipated time on study treatment is 12 weeks.   "
153309|NCT01277068|"     Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent.     Cardiovascular diseases are the first cause of morbidity and mortality. An excess of TRL     particles is one of the characteristics, represents a major cardiovascular risk factor. The     overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is     recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL     has been shown. In front of this important overmortality, the bariatric surgery quickly     developed. Three main procedures are performed: 2 based exclusively on the gastric     restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating a     malabsorption (the gastric bypass).   "
153310|NCT01277055|"     Coronary artery disease (CAD) has a great significance concerning prevalence and mortality in     the western world. It is usually diagnosed by catheterization and coronary arteries are     visually assessed by the examiner. Thus having a great spectrum of interobserver differences,     especially when it comes to intermediate lesions. The gold standard to assess the     haemodynamic significance is the measurement of the myocardial fractional flow reserve (FFR).     The FAME-study (Tonino, De Bruyne et al. 2009) was able o show that additional FFR-     measurements in patients with intermediate lesions could significantly reduce stent     implementation and consequently mortality. However this method is not used in daily routine     and is available only in a fraction of catheter labs worldwide. Taking this into account     decision finding especially in intermediate lesions remains difficult.      One major step to simplify the invasive approach concerning intermediate lesions would be to     establish a non-invasive procedures which localizes the coronary vessel to intervene ahead     catheterization.      Do to steady technical development cardiac MRI has become a powerful tool which is able to     determine myocardial vitality, perfusion and function. In particular the new generation of 3     Tesla multi transmit MR with its higher field strength and better spatial resolution seems to     be able to show first pass myocardial perfusion more precise. With this new technology     prefixed to cardiac catheterization clinical relevant information can be made accessible and     thus reduce the number of unnecessary implemented stents.   "
153311|NCT01277042|"     This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human     papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects     will receive the HPV vaccine and the other group will receive an active control (GSK     Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with     those from the HPV group included in the NCT00779766 study (aged 18-25 years).   "
153312|NCT01277029|"     To identify the differences in psychopathology, personality traits among different female     LUTS subtypes.   "
153313|NCT01277016|"     In this multi-center phase III trial, untreated patients diagnosed with AL who are not     candidates for stem cell transplant with melphalan 200 mg/m2 are the target population. Stage     I and II patients will be eligible. Stage III patients will be enrolled in an ancillary phase     II study. Eligible patients will be stratified as cardiac stage I or stage II and then     randomized to receive MDex or BMDex.      Primary objective is to compare hematologic(clonal) response i.e. the rate of complete     response (CR) + partial response (PR) defined according to the criteria of the International     Society for Amyloidosis consensus.   "
153314|NCT01277003|"     Carpal tunnel syndrome (CTS) is the most common compressive focal mononeuropathy seen in     clinical practice. Patients commonly experience a constellation of symptom complex brought on     by compression of the median nerve as it traverse through the carpal tunnel. When compression     of the nerve occurs, ischemia and mechanical disruption of nerve function may result.     Pathological analysis shows a constellation of nerve injuries. Until now, no satisfactory     conservative treatment method. Local steroid injections or oral steroids may result in     initial relief, but relapses are frequent and have much side effects, which preclude their     routine use for CTS. Full time wrist splints are claimed effective, but compromise hand     function and daily activities. There are reasonable studies showing relief of pain with     acupuncture on diverse pain conditions. However the therapeutic efficacy of acupuncture in     CTS was less convincing in the past. Until recent decade, some case reports and few     prospective studies reported the therapeutic effect of acupuncture in CTS. Other study also     reported that low-level laser and microamperes transcutaneous electrical nerve stimulation     (TENS) are effective in improvement of clinical outcome of patients with CTS. Another report     suggested that TENS should be considered for the treatment of painful diabetic peripheral     neuropathy. Therefore, the investigators perform this study to evaluate the effect of Aculife     Magnetic Wave Therapist (a battery operated device with a probe electrode which contains     magnetic elements that transform the oscillating current into an electromagnetic wave to     stimulate the acupuncture points, simulate the effect of electroacupuncture ) on CTS and     compared with that of Transcutaneous Electrical Nerve Stimulation(TENS). After at least 4     weeks treatment ( at least 16 treatment sessions) the therapeutic effects will be evaluated     by comparison of symptom severity score, electrophysiological study, sonographic morphology     study or magnetic resonance imaging study, before and after treatment, and between the     different groups.   "
153315|NCT01276990|"     To investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers     following oral administration of repeated doses for 10 days within 8 dosing regimens.   "
153316|NCT01276977|"     The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs.     eletriptan 40 mg tablet in the acute treatment of migraine.      To develop and evaluate a set of importance weights for a predefined set of treatment     attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg     tablet.      To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at     early time points.      To analyze the patterns of self-reported tolerability of migraine sufferers using     zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.   "
153317|NCT01276964|"     Multicenter, observational, cross-over study intended to apply an easy and simple system for     the quantitative determination of menstrual losses in women with apparently normal menses.The     system adopted for the determination of menstrual losses, called QUEM (QUantitative     Evaluation of Menses), is based on the collection of tampons and pads in standard bags which     are readily vacuum sealed with a simple device for the whole of woman's period. The     evaluation will be performed for the whole of one period and the analysis will be performed     in comparison to the classical reference method, the Alkaline - Hematin Method, which is     still considered the golden standard.   "
153337|NCT01276704|"     The investigators would like to see if women at increased risk for breast cancer are likely     to tolerate SDG daily for 12 months without significant side effects or changes in their     menstrual cycles. The investigators would also like to determine if Brevail® can reduce     breast cell proliferation in pre-menopausal women.   "
153547|NCT01273974|"     The purpose of this study is to determine whether half-dose intradermal influenza vaccine is     as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.   "
156677|NCT01233232|"     The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients     with Chronic Obstructive Pulmonary Disease   "
153318|NCT01276951|"     In Colombia, ischemic heart disease and stroke are one of the most important causes of death     in 45 years old people. Care of cases of disease represents high costs for the health system     in particular and society in general, due to the loss of productive years life and costs for     the care of the aftermath. Hypertension (HT) is one of the preventable risk factors for major     cerebrovascular disorders. The pathophysiology of Essential hypertension is complex and     depends of interaction of genetic and environmental factors. Among the determining elements     are the increase in the activity of the sympathetic nervous system, the vasoconstricting and     overproduction of hormones associated with sodium retention, disruption in renin secretion     with increased production of aldosterone and angiotensin II, the deregulation of the kinins     system, the increase in peripheral vascular resistance and activity of Growth factors in     atherogenesis and vascular endothelial dysfunction, increased cardiac output, diabetes     mellitus, obesity, and lower production of vasodilators such as brain natriuretic peptide     (BNP), the prostacyclins and nitric oxide (NO), among others.      Cocoa is a food rich in flavonoids, which stimulate the enzyme activity of endothelial nitric     oxide synthase (e-NOS), responsible of the production of NO in vascular smooth muscle. The     flavonoids modulate the synthesis of inflammatory substances that are derived from     endothelial cells and the immune system.      In a recent study found that with a few grams of cocoa achieves a significant reduction in     blood pressure, so the investigators propose a controlled clinical trial to assess the effect     of different doses of cocoa on blood pressure and endothelial inflammation in men with     essential hypertension, stage I-II without target organ damage, in addition to pharmacologic     monotherapy defined for the management of their disease. The investigators hope to determine     an optimal dose of cocoa, with long-term effects, by their high content of flavonoids,     improves cardiovascular and endothelial parameters with the advantage that it is an     economical and easy introduction into the patient's habits.   "
153319|NCT01276938|"     Aim of the study is to evaluate toxicity in breast cancer patients treated with two different     doses of Intra Operative Radiotherapy   "
153320|NCT01276925|"     Patients undergoing total hip arthroplasty may experience severe postoperative pain. This is     normally treated with opioids, which can cause side effects such as nausea, vomiting,     obstipation and sedation. The hypothesis is that patients receiving peripheral nerve blockade     of three nerves leading pain stimuli from the hip will experience less pain, will consume     less opioid and therefore have less side effects, and will be mobilized more quickly than     patients not receiving the peripheral nerve blockade.   "
153321|NCT01276912|"     -  Pre-diabetes is a significant risk factor for the development of type 2 diabetes, as          well as macrovascular and microvascular complication.        -  Previous studies show that 50% or more loss in islet B-cell function even in          Pre-diabetes phase. The early insulin therapy in pre-diabetes may be a strategy in          preventing metabolic disorders and cardiovascular disease.        -  The objective of this study is to find if an initial insulin glargine intervention in          pre-diabetes (IGT and /or IFG) could be a strategy in preventing type 2 Diabetes.        -  Pre-diabetes subjects will receive a insulin glargine therapy with a dosage adjusted to          get FBG ≤ 5.3mmol / L as the goal. Insulin glargine treatment will be maintained for          three months thereafter to find if it can prevent diabetes.   "
153322|NCT01276899|"     This is a multicenter translational study to understand therapeutic resistance in patients     undergoing standard chemotherapy for triple negative breast cancer.      In the neoadjuvant setting, biopsy tissue samples from primary tumor will be collected and     banked before the start of chemotherapy and after the completion of the treatment     (post-chemotherapy and at the time of surgery). In the metastatic setting, tissue samples     from metastatic lesions will be collected and banked before the start of chemotherapy and at     the time of tumor progression. Additionally, blood samples will be drawn before treatment     initiation (baseline) and at different time points during treatment. All samples will be     stored in the Biological Resource Repository.   "
153323|NCT01276886|"     Patients were recruited over a four year period from 1996 to 1999. Those admitted in the     years 1996 and 1997 were retrospectively accrued from the clinical records, while patients     treated between 1998 and 1999 patients were entered on the database prospectively on     admission.      Inclusion criteria All consecutive patients with left sided acute diverticulitis diagnosed     clinically by the presence of abdominal pain, associated with leukocytosis (>11x109) and/or     fever >38°C, confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema)     either alone or in combination and/or by operative findings, entered the study. The CT     criteria for the diagnosis included a localized thickening (≥4 mm) of the colonic wall and     signs of inflammation of the pericolic fat, with abscess and/or extraluminal air and/or     extraluminal contrast. The criteria for ultrasound included at least two of the following     signs: bowel wall thickening (>4 mm), diverticular inflammation, pericolic fat edema,     intramural or pericolic inflammatory mass, intramural fistula. The diagnostic criteria for     water soluble contrast enema included segmental luminal narrowing and a tethered mucosa with     or without a mass effect or extravasation of contrast and/or the presence of extraluminal     air.      Exclusion criteria Patients with inflammatory bowel disease, irritable bowel syndrome,     colorectal cancer or diseases precluding adequate follow up, were excluded from the study.      Treatment Patients were treated conservatively (antibiotics, I.V. nutrition, CT/US guided     abscess drainage) or surgically according to the local policy of each center.      Follow up Follow up was carried out according to local policy. The following data were     collected: persistence or recurrence of chronic symptoms attributable to complicated     diverticular disease, new episodes of AD, new hospital admissions for AD, type of treatment     and outcome.      Recurrence was defined as a new episode of AD requiring hospitalization that occurred at     least 2 months after complete resolution of the index episode which resulted in inclusion in     the study. If surgery was performed, the timing, type of procedure, Hinchey stage and     complications were recorded.      Data collection A standardized flow sheet was used to collect data on medical history,     diagnostic work up, type of treatment and follow up to create a dedicated database. Gender,     age, date of hospital admission and discharge, diagnosis on admission and discharge,     co-morbidities (diabetes mellitus, cardiovascular disease, atherosclerosis, liver or renal     failure), symptoms experienced before admission and their duration, history of     diverticulosis, previous episodes of AD, laboratory tests, and treatment performed were     recorded. Where surgery was performed, the date and type of procedure, the operative findings     including Hinchey's classification (16) and details of the operation (incision, extension of     resection, type of anastomosis, covering stoma, drains), pathology report, and postoperative     complications occurring within 30 days, were all recorded.      End points The primary endpoint was to assess the rate of recurrence of AD requiring     hospitalization during the follow-up period. Additional endpoints were to assess the risks of     emergency surgery, stoma and disease-related mortality during the follow up.   "
153324|NCT01276873|"     To compare clinical effects identified in infants undergoing intratracheal aspiration with     open and closed systems and verify the presence and intensity of pain in newborns during     intratracheal suction, according to the system applied.Clinical, randomized, controlled, and     crossover study, performed at two neonatal intensive care units after approval by the ethics     committee. The sample consisted of infants from zero to seven days of age, 26 weeks of     gestational age, and the exclusion criteria were use of mechanical ventilation with     high-frequency oscillatory, in use of inhaled nitric oxide, in the acute phase of circulatory     failure, central nervous system disorders, without reactivity to stimulus, severe asphyxia,     Apgar score less than three in the fifth minute, as well as, presence of chromosomal     abnormalities and congenital malformations. After obtaining the informed consent from the     responsible, children were randomly allocated into the experimental (CS) and control (OS)     groups. The dependent variables of this study respiratory rate (RR), peripheral oxygen     saturation (SatpO2), heart rate (HR), blood pressure (BP) and pain, as well as, of the     complementary variables, were collected through observation, the Premature Infant Pain     Profile (PIPP) scale application and medical records consultation. During the data collection     the period of variables observation were: T1 (immediately before suctioning), T2 (during     suctioning), T3 (immediately after) and T4 (10 minutes after). To the statistical analysis     were applied Fisher exact test, McNemar, Binomial, Student t test, Wilcoxon and Mann Whitney,     settling at 0.05 level of significance.   "
153325|NCT01276860|"     Obstructive sleep apnea results in decreased attentiveness and response times in patients.     The objective of this study is to quantify these consequences in pediatric OSA patients using     an already established tool for examining the results of sleep deprivation and fragmentation:     psychomotor vigilance testing. PVT has been used in children, but has not been studied in     pediatric OSA patients. This study aims to employ PVT along the normal course of diagnosis     and treatment of pediatric OSA patients in our clinical practice at Arkansas Children's     Hospital. The investigators hypothesize that pediatric OSA patients will exhibit decreased     PVT scoring when compared to children without OSA, and that PVT can be used to diagnose and     monitor treatment outcomes in these patients.   "
153326|NCT01276847|"     This is a two-part study. The purpose of the pilot study (Part 1) is to optimize the     acquisition, handling and shipping procedure for skin biopsies obtained from participants     with plaque psoriasis. No treatment will be administered. Part 2 will include 2 cohorts. In     Cohort 1, the effects of 16 weeks of treatment with either ustekinumab or etanercept on     biomarkers in lesional skin in participants with moderate to severe psoriasis will be     evaluated. In Cohort 2, biomarkers of lesional skin from participants with moderate to severe     psoriasis who are not treated with biologic therapy will be evaluated over 16 weeks. The     primary hypothesis is that treatment with ustekinumab reduces messenger RNA (mRNA) expression     of genes in the interleukin 12 (IL-12) pathway that are modulated by interferon gamma     (IFN-γ).   "
168545|NCT00034580|"     This is a research study comparing the safety and efficacy of two active study medications     for the treatment of bipolar I disorder.   "
153329|NCT01276808|"     Rationale: Magnetic navigation in complex lesions/vessels may result in reduced contrast and     irradiation for patients undergoing percutaneous coronary intervention. The investigators aim     to compare the use of the 2 techniques.      Objective: To compare the use of contrast and irradiation used in magnetically navigated PCI     (MPCI) with conventional guidewire PCI (CPCI) in patients with complex anatomy (as defined by     a clinical prediction rule).      Study design: Prospective randomised controlled, single-blind trial Study population: Healthy     human volunteers aged 18 to 80 years of age Intervention (if applicable): One group has the     placement of the angioplasty wire with magnetic navigation and the other has the angioplasty     wire placed by conventional technique. All other interventions will be performed as per     routine practice.      Main study parameters/endpoints:      Primary endpoint The primary endpoint is the amount of contrast used.      Secondary endpoints        1. Contrast needed to cross a lesion        2. procedural time        3. radiation exposure        4. Clinical complications at 1 and 12 months        5. procedural success      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      The index procedure is performed as per normal routine and includes history and examination.     A blood test will be taken once vascular access has been obtained. After the procedure a     questionnaire will be filled in. The patient will have a blood test 2 to 3 days after the     procedure, telephone follow-up will occur at 1 and 6 months and a further outpatient visit     with ECG will be planned for a year after the index procedure. No additional significant     physical or psychological discomfort is expected with participation in the study.   "
153330|NCT01276795|"     A prospective, randomized and controlled study is proposed to establish whether an enteral     nutrition support regimen based on pressurized whey protein and glucose improves the     postoperative utilization of amino acid substrates compared to a drink based on glucose     alone. The kinetics of protein metabolism (protein breakdown, protein synthesis and amino     acid oxidation) will be investigated using stable isotope methodology before and after     surgery in patients undergoing colon resection. Stable isotope infusions will be conducted     one week before surgery and on the second postoperative day for two hours in the fasted state     and for four hours while sipping the enteral nutrition support regimen. Patients will consume     one of two enteral nutrition support regimens consisting of a drink containing either     pressurized whey protein and glucose or glucose alone. It is hypothesized that an enteral     nutrition support regimen based on pressurized whey protein and glucose promotes positive     protein balance through increased protein synthesis or reduced protein breakdown compared to     glucose alone.   "
153331|NCT01276782|"     The last two decades have witnessed an explosion of new research documenting the deleterious     impact that thyroid disease has on pregnancy and the postpartum period, in relation to     miscarriage preterm delivery intelligence quotient of the unborn child and health of the     mother postpartum. Both subclinical hypothyroidism and thyroid antibody positivity in     euthyroid women have been associated with miscarriage and preterm delivery. Approximately 5%     of all pregnant women have a thyroid disorder. both spontaneous miscarriage and preterm     delivery.      Systemic lupus erythematosus (SLE), an autoimmune disorder of unknown etiology, has also been     documented to negatively impact pregnancy. Women with Systemic lupus erythematosus (SLE)have     increased rates of miscarriage and preterm delivery. Women with Systemic lupus erythematosus     (SLE) also have increased rates of hypothyroidism and autoimmune thyroid disease (AITD,     defined as the presence of thyroid antibodies with or without thyroid dysfunction). Preterm     delivery (PTD), defined as birth prior to 37 weeks gestation, is the leading cause of     neonatal mortality and morbidity in the United States. Although risk factors for preterm     delivery exist, the majority of women have no known risk factors. Recently, both     hypothyroidism and autoimmune thyroid disease have also been linked to preterm delivery.     Given the increased prevalence of negative outcomes documented in pregnant women with thyroid     disease, and the increased rates of hypothyroidism and Autoimmune thyroid disease in women     with Systemic lupus erythematosus (SLE), the investigators determined that Autoimmune thyroid     disease was associated with both preterm delivery and miscarriage. This has led to this     application to begin a pilot randomized clinical trial of thyroxine in autoimmune thyroid     disease in systemic lupus erythematosus pregnancy.   "
153332|NCT01276769|"     This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel     plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized     that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel     plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and     sensitive to carboplatin.   "
153333|NCT01276756|"     Chronic hepatitis C has become an endemic disease in Egypt with a rising prevalence (genotype     4), worldwide it also poses a significant health burden. To date standard of care treatment     (pegylated interferon and ribavirin) give modest results with a sustained virological     response (SVR) of about 50%. Several pharmaceutical and herbal agents have been used with an     aim to improve current results. Recent reports have suggested an increased SVR with the     addition of Nitazoxanide to standard of care. The results are preliminary and need to be     confirmed. This is a randomized trial to assess the efficacy of nitazoxanide added to     standard of care compared to standard of care alone.   "
153334|NCT01276743|"     The protein tyrosine phosphatase non-receptor type 22 (PTPN22) gene encodes a     lymphoid-specific phosphatase (LYP) which is an important downregulatory factor of T cell     activation. A PTPN22 polymorphism, C1858T, was found associated with T1DM in different     Caucasian populations.      In this observational case-control study, we aimed at confirming the role of PTPN22, C1858T     polymorphism in T1DM predisposition in a Greek population.   "
153335|NCT01276730|"     The study objective:        -  To evaluate the response and survival rates after treating stage III cervical cancer          with retinoic acid and interferon-α combined with radiotherapy in the study group.        -  To evaluate the response and survival rates after treating stage III cervical cancer          patients with concomitant cisplatin and radiotherapy in the control group.        -  To evaluate the safety and tolerability of the combination of retinoic acid,          interferon-α and radiation therapy compared with concomitant chemo-radiation therapy.        -  To determine if there is an immune response to Human Papillomavirus (HPV) by estimating          serum IgG1 and IgG2 antibodies against E7 proteins of HPV types 16 and 18 before and          after treatment.      The study hypothesis:        -  The response rates and survival rates of retinoic acid and interferon-α combination with          radiation will be better than chemo-radiation to treat stage III cervical cancer.        -  Treatment with the retinoic acid, interferon-α and radiation combination therapy will be          less toxic and better tolerated than chemo-radiation therapy.   "
153336|NCT01276717|"     This will be a phase I study of carfilzomib in combination with vorinostat in patients with     relapsed/refractory B-cell lymphomas. Combination therapy with proteosome inhibitor PR-171     and HDAC inhibitors is highly synergistic in primary DLBCL cells, and both classes of drugs     can also synergize powerfully to induce cell death in bortezomib-resistant cells. The purpose     of this study is to see if vorinostat can combine with carfilzomib and to safely find the     recommended phase II dose.   "
179664|NCT00188162|"     The aim is to evaluate whether Minimum Dose CT (MnDCT) is useful in the management of     patients post Lung Biopsy   "
153338|NCT01276691|"     The investigators hypothesize that        1. an acute treatment of low-dose aspirin will lead to a) decreased resting platelet          activation, platelet aggregation, and clotting potential, b) increased fibrinolytic          potential following fire fighting, c) no significant effect on endothelial function or          arterial stiffness versus the placebo condition.        2. chronic treatment with low-dose aspirin will lead to a) decreased resting and fire          fighting induced platelet activation, platelet aggregation, clotting potential, b)          increased fibrinolytic potential, and c) increased endothelial function and decreased          arterial stiffness in response to live fire fighting versus the placebo condition.        3. short-term fire fighting activity will result in: a) a reduction in arterial function          (reduced endothelial function, increased augmentation index and an attenuated arterial          stiffness response); b) a disruption in hemostasis that is characterized by an increase          in platelet number and function, an increased coagulatory potential and altered          fibrinolytic potential; and c) an elevation in procoagulatory cytokines, systemic          inflammation, monokine chemoattractant protein, and matrix metalloproteinases.   "
153339|NCT01276678|"     About 13 million people in the United States have coronary artery disease (CAD). It is the     leading cause of death in both men and women.      Coronary artery disease (CAD) occurs when the blood vessels that supply blood to the heart     muscle (the coronary arteries) become hardened and narrowed. The arteries harden and narrow     due to buildup of fatty and calcified material called plaque on their inner walls. The     buildup of plaque is also called atherosclerosis. This is a process which starts early in     life, but can be influenced by multiple factors.      Several factors increase the risk of developing atherosclerosis. They include high blood     pressure, smoking, diabetes, high cholesterol and being related to someone who had a heart     attack or a stroke. The more risk factors you have, the greater the chance that you have     severe atherosclerosis. Some of the risk factors cannot be modified, like age and family     history of early heart disease. The influenceable factors include high blood pressure, high     blood cholesterol, high blood sugar, cigarette smoking, overweight or obesity, and lack of     physical activity.      Nevertheless, there are patients without any above mentioned risk factors who develop     atherosclerosis. In addition to that, there are also patients with several risk factors who     do not develop severe coronary artery disease.      According to research studies high blood levels of some substances in the blood (biochemical     markers) as well as some genes in the DNA of our cells may be associated with an increased     risk of developing CAD and faster progression of the disease.      The purpose of this study is to find a correlation between certain blood markers and growth     of the plaques, regardless of the presence of the classic risk factors for atherosclerosis.     If we prove our hypothesis we will be one step closer to predicting the extent of     atherosclerosis by performing certain blood tests.   "
153340|NCT01276665|"     Perioperative fluid management in abdominal surgery is a subject of controversy and current     standard fluid therapy is not evidence based. Compensating decreasing blood pressure by     volume substitution is common praxis. Alternatively the fall in blood pressure due to     vasodilatation can be corrected by applying vasoactive agents. A review of the data on the     effect of high volume perioperative fluid therapy suggests that overhydration may have     deleterious effects on cardiopulmonary function as well as on recovery of gastrointestinal     motility, tissue oxygenation and wound healing. Restrictive fluid administration in     fast-track surgery led to no differences in all-over recovery after colonic surgery. Based on     our current knowledge, a low volume regimen combined with a noradrenaline perfusor may be of     benefit during open radical cystectomy. It seems of interest and safe to use a noradrenaline     perfusor combined with a low volume regimen during open radical cystectomy. The low volume     regimen, as described in this study protocol, is well established at our institution, which     has a large experience in cystectomy.      The aim of this study is to compare intraoperative blood loss, quality of the surgical field,     metabolic response, pain relief, fatigue score, gastrointestinal function, cardiovascular,     pulmonary, infectious and surgical complications as well as cognitive function in two groups     of patients undergoing radical cystectomy.      The investigators expect a lower complication rate in the restrictive fluid regimen group and     better surgical conditions. This could significantly affect short- and long-term outcome of     patient undergoing major cancer surgery, have an impact on survival and financial     consequences.   "
153341|NCT01276652|"     This study examines the feasibility of assessing sleep and circadian rhythmicity in     critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the     feasibility of reducing subject exposure to environmental light and noise and of delivering     routine care according to classical day/night routines.   "
153342|NCT01276639|"     The main objective of this study is to compare the effects of CP-690,550 with the effects of     placebo in patients being treated for moderate to severe chronic plaque psoriasis. This     one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.   "
153343|NCT01276626|"     The purpose of this study is to determine whether probiotic bacterium Bifidobacterium longum     (B. longum) can improve mood and bowel symptoms in patients with Irritable bowel syndrome     (IBS). The patients will be treated with probiotic or placebo for 6 weeks. Their mood,     memory, general well-being and bowel symptoms will be assessed before, at the end of the     treatment and 4 weeks later. Brain activation pattern, changes in gut bacteria, metabolic     profile and inflammatory markers will be also measured.   "
153344|NCT01276613|"     The goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer     cells, to measure the amount of it that may enter the cells, and for biomarker testing.     Biomarkers may be related to participant's reaction to the study drug.   "
153345|NCT01276600|"     Describe the dose-proportionality and intra-individual variability of tenofovir diphosphate     (TFV-DP) and emtricitabine triphosphate (FTC-TP) at steady-state in healthy human     participants taking Truvada® (FTC 200mg/TDF 300 mg) under direct observation.   "
153346|NCT01276587|"     This pilot study aims to answer the question whether monthly oral vitamin D3 supplementation,     100,000 IU, will be safe and effective in raising serum 25-hydroxyvitamin D (form of vitamin     D measured in the blood) to levels considered sufficient (30 ng/mL) but well below the     threshold for toxicity (150 ng/mL) in children with sickle cell disease. Information from     this study will be crucial before we perform a larger clinical trial to determine the effects     of vitamin D in reducing respiratory complications in patients with sickle cell disease.   "
153387|NCT01276054|"     Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity     of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or     axillary lymph node biopsy with or without axillary reverse mapping works in reducing     incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer   "
153548|NCT01273961|"     The purpose of this pilot research study is to collect information on the safety and     effectiveness of an experimental device used to treat and improve the appearance of the skin     by reducing the visibility of wrinkles and by reducing the looseness of skin.   "
153347|NCT01276574|"     The purpose of this study is to determine, whether there is clinical benefit of using     fdg-PET/CT (F-18-fluorodeoxyglucose- positron emission tomography/computed     tomography)compared to contrast-enhanced CT in primary treatment of advanced epithelial     ovarian cancer (EOC)        -  Objectives             -  the impact of preoperative PET/CT compared to CT on EOC stage definition             -  to compare the value of preoperative PET/CT, CT and laparoscopy in intra-abdominal               tumour assessment. Laparotomy findings evaluated by surgeon and histopathologic               results serve as the reference standard.             -  to compare serum markers HE4(human epididymis protein 4) and CA125 (cancer antigen               125) with FDG-PET/CT and CT in treatment response evaluation during neoadjuvant               chemotherapy and primary treatment of EOC             -  to compare FDG PET/CT based treatment response evaluation with RECIST and GCIG               criteria        -  Methods             -  All the patients will undergo FDG-PET/CT prior surgery, after possible neoadjuvant               chemotherapy (NACT) and 4 weeks after completion of primary platinum-based               chemotherapy.             -  CA125 and HE4 levels are measured pre-operatively and with every chemotherapy               cycle.   "
153348|NCT01276561|"     This is a prospective trial of single incision versus standard 4-port laparoscopic     splenectomy.      The hypothesis is that there may be a difference in wound infection rates, operative time,     doses of analgesics post-operatively, and patient/parent perception of scars. However, the     technical difficulty is considerable and the primary outcome is operative time which will be     expressed in minutes.   "
153349|NCT01276548|"     The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of     Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment     in Subjects With Ovarian Cancer.   "
153350|NCT01276535|"     The purpose of this study is to determine whether low level laser light therapy is effective     in the treatment of acne blemishes.   "
153351|NCT01276522|"     Schnitzler syndrome is a disabling inflammatory disease, characterized by chronic urticaria,     fever, arthralgia, bone pain and gammopathy, which can so far only be effectively treated     with anakinra, an interleukin-1 receptor antagonist. However, this drug is not registered for     use in Schnitzler syndrome, and it needs to be injected daily, which is uncomfortable and     unpractical. Therefore other treatments targeting IL-1 are needed. Canakinumab is a     long-acting monoclonal antibody against IL-1β that has been registered for bimonthly use in     the rare autoinflammatory disease Cryopyrin-associated periodic syndrome (CAPS). We     hypothesize that it will be effective in Schnitzler syndrome too in view of clinical     similarities to CAPS and the targeting of IL-1B, which is also blocked by anakinra (which     blocks both IL-1B and IL-1A).      This is a 6-month open-label, single treatment arm study of canakinumab 150 or 300 mg (in     case of insufficient response to 150 mg) subcutaneous injection once per month in patients     with active Schnitzler syndrome, in which efficacy and safety will be assessed.   "
153352|NCT01276509|"     Adults with Crohn's disease that is clinically active despite conventional treatment will be     eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental     drug) or placebo (inactive drug). Disease activity will be measured every two weeks.   "
153353|NCT01276496|"     This phase I trial studies the side effects and the best dose of cilengitide when given     together with paclitaxel weekly in treating patients with solid tumors that have spread     nearby or to other areas of the body and cannot be removed by surgery. Cilengitide may stop     the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as paclitaxel, work in different ways to the stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving cilengitide together with     paclitaxel may kill more tumor cells.   "
153354|NCT01276483|"     The purpose of this study is to compare sensitivity, specificity and accuracy of PET, DW MRI     and CT separately and combined for the evaluation of treatment response and progression-free     survival in patients with GIST.   "
153355|NCT01276470|"     Background:        -  Like other complex diseases, autoimmune diseases are the result of numerous causes,          including genetic and environmental factors. Some researchers believe that people who          are susceptible to autoimmune disorders develop them when the body reacts to          environmental or other factors by creating white blood cells that attack the body s own          tissues, which then progresses to autoimmune diseases. These immune-triggered disorders          can overlap with one another to some extent, but most autoimmune diseases have certain          distinct triggers.        -  The autoimmune disorder myositis weakens the muscles and may cause other health          problems. Environmental exposures associated with myositis include ultraviolet          radiation, stressful life events and muscle overexertion, collagen implants, infections          such as retroviruses and streptococci bacteria, and certain drugs and chemicals. Some          individuals with myositis also produce proteins in the blood called autoantibodies that          react with certain parts of the person s own cells, called synthetases, which are          involved in making new proteins. A syndrome called the anti-synthetase syndrome, which          includes myositis and lung disease, is associated with having the anti-synthetase          autoantibodies. Researchers are interested in studying differences in environmental          exposures in individuals with myositis. This study is being conducted to determine if          persons with the anti-synthetase syndrome have had different environmental exposures          before disease onset compared with other patients with myositis who do not have this          syndrome and also compared with healthy volunteers.      Objectives:      - To determine whether selected infectious and noninfectious environmental exposures are more     common in individuals who have myositis with the anti-synthetase syndrome, compared with     healthy volunteers.      Eligibility:      - Individuals who have been diagnosed with myositis (with or without anti-synthetase     autoantibodies), and healthy volunteers without autoimmune disorders.      Design:        -  Participants will be screened with a full medical history and physical examination, and          will provide blood, urine and house dust samples.        -  Participants will complete questionnaires about their medical history and the types of          exposures they have had at work, at home, and elsewhere. Participants who have myositis          will also be asked about certain infections, heavy exercise or physical exertion, sun          exposure, tobacco and alcohol use, and stressful events prior to being diagnosed with          the disease. Healthy volunteers will be asked about the same exposures before the date          of diagnosis of disease of the myositis subject to which they have been matched.        -  Participants will receive a kit that contains instructions and a filter to be put onto          their vacuum cleaner to collect house dust in the bedroom. This dust will be kept for          possible future analyses of infectious or toxic agents based on the other results from          the study.        -  Individuals with myositis will have other tests as clinically indicated, including lung          function tests and imaging studies.   "
153356|NCT01276457|"     The purpose of this study was to allow the continuation of everolimus treatment in patients     who have completed the core study (NCT00170885) and to collect long-term safety,     tolerability, and efficacy data in a group of patients treated with the upper everolimus     target levels plus very low dose cyclosporin in comparison with the standard everolimus     target levels plus low dose cyclosporin in patients with renal transplantation.   "
153370|NCT01276275|"     The purpose of the study is to describe patient characteristics and drug usage among patients     that are prescribed ticagrelor for the first time and to compare them with patients who are     prescribed clopidogrel and prasugrel for the first time.      A further purpose is to ascertain and estimate the crude incidence rate of bleeding,     arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea and gout among     new users in the three cohorts of ticagrelor, clopidogrel and prasugrel.   "
181711|NCT00223132|"     The purpose of this study is to evaluate the effect of different suture material on the     incidence of suture granuloma.   "
153357|NCT01276444|"     Valvular repair and repair surgery is rapidly progressing yet rather challenging aspect of     current cardiosurgical practice.      Several approaches were introduced into the clinical practice to alleviate systemic     inflammatory response induced by cardiopulmonary bypass and organ-specific injury including     meticulous haemodynamic monitoring, pharmacological heart preconditioning, systemic use of     anti-inflammatory agents, prevention of coagulopathy, and induced topical and systemic     hypothermia. An in-depth monitoring of haemodynamics, oxygen transport, and vascular     permeability is of a great clinical value to control the efficacy of these approaches.      Therefore, the aim of this study was to compare two algorithms of goal-directed therapy aimed     to achieve a postoperative haemodynamic optimization in combined valve repair surgery.   "
153358|NCT01276431|"     An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and     safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe     osteoarthritis pain of the hip and/or knee.   "
153359|NCT01276418|"     This study is intended to collect data regarding treatment with a new flexible fiber used to     transmit laser emitted from a Carbon dioxide (CO2) laser to the transoral region. This study     will include a single treatment that is performed transorally (through the mouth) for oral or     laryngeal indications in the field of Ear, Nose and Throate (ENT).   "
153360|NCT01276405|"     This observational study will evaluate Xeloda (capecitabine) monotherapy on the effect of     disease-free survival in patients with colon cancer stage III (Duke C) after surgical     resection. Data will be collected for 3 years.   "
153361|NCT01276392|"     Actual clinical practice predominantly makes use of heparin (systemically) or citrate     regionally as anticoagulation in the extracorporeal circulation for renal replacement     therapy. We aim to find out if different anticoagulation strategies may lead to different     levels of platelet activation and whole blood coagulation. Regarding coagulation activation,     it remains uncertain if there is an advantage for one of these methods. However, it is of     major interest to minimize the risk of any additional clotting activation via extracorporeal     circulation in these usually critically ill patients.   "
153362|NCT01276379|"     Advanced colorectal cancer (ACRC) is a heterogeneous disease and classification of patients     is nowadays inefficient. Roughly twenty per cent of patients present with favorable figures     (less than 4 liver nodules and less than 5 cm) and are suitable for local treatments (surgery     or local-ablative therapies). Additionally, 10-15% of patients have poor performance status     (PS >2) or are severe disabled due to geriatric syndromes or/and co-morbid diseases that     preclude any treatment strategies than best supportive care alone. The rest of patients (fit     patients not suitable for radical treatments) constitute the population of patients treated     with palliative therapies. Despite of it not all these patients have the same prognosis.     Patients with PS 0,1 and levels of LDH <ULN (Intermediate-risk patients) have better PFS and     OS irrespective of therapy in all randomized clinical trials (de Gramont et al, JCO 2000;     Douillard et al, Lancet 2000; Koopman et al, 2007).      CRYSTAL trial shows a benefit in PFS (1.5 months) in RASWT of FOLFIRI plus cetuximab compared     with FOLFIRI alone. Nowadays the selection of patients for cetuximab treatment is based on     mutational status of KRAS, which allow to select those patients who will not respond to     therapy. Other surrogate markers of activity should be also evaluated. Our hypothesis is that     the suggested biomarkers will allow the selection of the patients who will benefit the most     from the biweekly cetuximab treatment.   "
153363|NCT01276366|"     Last thirty years, many research was performed concerning pain in the newborn. These     investigations showed us the negative effects of pain in the neonatal period. Our research     concerns the choice of analgesics for the premature newborn during a heel lance. Newborns     with a gestational age of 32-37 weeks are randomly assigned over three groups. They can     receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or     sucrose.      The primary objective of the Amphia Premature Infant Pain study, is to investigate whether     there is a difference in PIPP-scores in premature newborns who undergo a heel lance,     receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in     newborns receiving breast milk compared to sucrose. And the investigators presume that breast     feeding has the same analgesic effect as giving supplemental breast milk.   "
153364|NCT01276353|"     The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the     currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with     severe Alzheimer's disease.   "
153365|NCT01276340|"     The investigators performed a prospective analysis of 450 women with stress, urge and mixed     incontinence in order to assess the health-related quality of life (Contilife® questionnaire)     and the objective cure rate after two months of electrical stimulation (Keat® stimulator).     Management of urinary incontinence with the Keat® stimulator could given an improvement in     the quality of life and a good rate of satisfaction without side effect.      Objective cure is as good as subjective improvement especially in urinary stress     incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the     bew first-line non surgical treatment for female urinary incontinence.   "
153366|NCT01276327|"     The objective of the current study is to establish the bioequivalence of linagliptin/     pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and     pioglitazone administered together.   "
153367|NCT01276314|"     Severe skin adverse drug reactions can result in death. Toxic epidermal necrolysis (TEN) has     the highest mortality (30-35%); Stevens-Johnson syndrome and transitional forms correspond to     the same syndrome, but with less extensive skin detachment and a lower mortality (5-15%).     Hypersensitivity syndrome, sometimes called Drug Reaction with Eosinophilia and Systemic     Symptoms (DRESS), has a mortality rate evaluated at about 10%. The aims of this project are     (1) to compare the effect of treatment between systemic steroid and anti-TNF α. Including     skin re-epithelization time, internal organ recovery time, mortality rate, and (2) to     investigate the pathogenesis of severe cutaneous adverse reaction.   "
153368|NCT01276301|"     Relative bioavailability of BI 10773 given alone and together with verapamil   "
153369|NCT01276288|"     The primary objective of the study is to investigate the effect of BI 10773,     hydrochlorothiazide and torasemide on changes in serum and urine electrolytes. Furthermore     the pharmacodynamic and pharmacokinetic interactions between BI 10773 and diuretics should be     assessed.   "
189823|NCT00322621|"     To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from     Diabetic Neuropathy.   "
153371|NCT01276262|"     A crossover study to assess the effect of repeated doses of fostamatinib on the levels of     oral contraceptive (Microgynon® 30) in the blood of healthy female subjects. The study will     consist of a screening period of up to 35 days, followed by 2 treatment periods (28 days     each) of an oral contraceptive (Microgynon® 30) in the absence and presence of fostamatinib.     The study will also evaluate the safety and tolerability of fostamatinib in combination with     an oral contraceptive   "
153372|NCT01276249|"     The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the     clinical knowledge base by including 'real world' subjects.   "
153373|NCT01276236|"     The purpose of this study is to determine whether Maraviroc is effective in the treatment of     Kaposi's Sarcoma (KS), when it does not remit with standard antiretroviral drug therapy.   "
153374|NCT01276223|"     The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective     in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog     Scale (VAS) discomfort score.   "
153375|NCT01276210|"     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth or by blocking blood flow to the tumor. Stereotactic     radiosurgery (SRS) may be able to send x-rays directly to the tumor and cause less damage to     normal tissue. Giving sorafenib tosylate together with SRS may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and the best dose of sorafenib     tosylate when given together with SRS in treating patients with brain metastases   "
153376|NCT01276197|"     The purpose of this study is to determine if patients with high blood pressure are better     able to control their blood pressure after watching a DVD about blood pressure.   "
153377|NCT01276184|"     Human papillomavirus (HPV) is the most common sexually transmitted disease among adolescent     females in the United States. Our primary objective is to determine if Short Message Service     (SMS) text message reminders increase adherence to the recommended 3 dose schedule for     Gardasil compared to usual care in an outpatient clinic setting. Secondary objectives of this     study are: 1) to demonstrate the feasibility of using SMS text message reminders to increase     adherence with Gardasil vaccination; and 2) to assess satisfaction and acceptability of text     message reminders compared to telephone reminders among women who receive the text message     arm of the intervention. The investigators hypothesize that receiving SMS text message     reminders will increase adherence to the recommended 3 dose schedule for Gardasil compared to     usual care.   "
153378|NCT01276171|"     Radial arterial cannulation is a common invasive procedure for real-time measurement of     arterial blood pressure. Placement of the arterial catheter using conventional palpation is     often relatively easy and quick, but this is not always true. A relatively new method for     direct visualization of the artery is the use of two-dimensional ultrasound. This technique     allows cannulation of the artery to take place under real-time visualization and may increase     the success rate of first time pass of the needle. Another technique utilizing Doppler has     also proven to be effective in cannulating the radial artery. This technique utilizes changes     in acoustic pitch as the probe passes directly over the artery. The primary objective of this     study is to compare the first attempt success rate for radial artery cannulation among the     palpation, Doppler and U/S guided technique when applied by trainees. Secondary outcomes     include: success rate within 5 minutes, successful, number of attempts required, and     correlation between success rate and operator experience for successful cannulation of the     radial artery.   "
153379|NCT01276158|"     This prospective randomized study was designed to compare ultrasound guided technique with     Doppler assisted technique for radial arterial cannulation in infant and small children.   "
153380|NCT01276145|"     Subjects in this study have recently had or are scheduled for a coronary angiography as part     of their normal, routine medical care. This procedure uses x-ray imaging to see the inside of     the heart's blood vessels.      This research study will evaluate the possible relationship between erectile dysfunction and     vascular disease (diseases of the veins). In order to look at this possible relationship,     subjects will complete a questionnaire which will ask questions regarding their sexual     activity. Additionally, we will gather information from their medical records and take extra     images during the coronary angiography procedure.   "
153381|NCT01276132|"     Subjects in this study have recently had or are scheduled for a (percutaneous coronary     intervention) PCI as part of their normal, routine medical care. This procedure should     restore the blood flow in the vessels of the heart.      Recent studies have shown that stable patients who undergo PCI and are discharged home after     4 hours of observation do not suffer any more complications compared to patients who stay in     the hospital overnight. In addition, studies suggest that patients express increased     satisfaction at being discharged after 4 hours.      The University of Chicago is one of the first US medical centers to institute a formal     program of same-day discharge after PCI. This study will seek, through a analysis of medical     information and satisfaction questionnaires, to assess whether this particular same-day     discharge program can improve patient satisfaction and preserve patient safety.   "
153382|NCT01276119|"     To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by     intravenous infusion (iv) and subcutaneous (sc) injection.   "
153383|NCT01276106|"     This is a 24-week randomized placebo-controlled study to investigate the effect of an oral     IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on     different background diabetes therapies.   "
153384|NCT01276093|"     The purpose of the study is to demonstrate that in patients of 70 years or older with     symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF     ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of     AF.   "
153385|NCT01276080|"     This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose     crossover study was conducted to compare the relative bioavailability of equal doses of the     test and reference products under non-fasted conditions.   "
153386|NCT01276067|"     This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose     crossover study was conducted to compare the relative bioavailability of equal doses of the     test and reference products under fasted conditions.   "
156534|NCT01234844|"     In -patients in a geriatric rehabilitation unit, will participate in structured therapy with     guinea-pigs on the assumption that the therapy will reduce anxiety and improve the outcome of     their rehabilitation.   "
153388|NCT01276041|"     The purpose of this study is to see if a combination of drugs can help to treat this type of     cancer. One drug is a chemotherapy agent called paclitaxel (Taxol®). Paclitaxel will be given     every week through the vein. Although the weekly schedule of paclitaxel is not included in     the label, the schedule and dose of weekly paclitaxel have been studied and have been proven     to be more effective than an old standard schedule. The other two work against HER2. One is     called trastuzumab (Herceptin®) and it is commonly given to women with early HER2 positive     breast cancer or with advanced HER2 positive breast cancer that has spread to other parts of     the body. Trastuzumab will be given through the vein every 3 weeks (or every week at the     doctor's discretion). The third drug, pertuzumab, is an investigational drug. It has not been     approved by the Food and Drug Administration. It has been given in studies to over 800     people. It has been effective in treating HER2 positive breast cancer. Pertuzumab will be     given every 3 weeks through the vein. This study is looking at the effectiveness of these     three drugs together.   "
153389|NCT01276028|"     The primary purpose of this study is to determine the effectiveness of acupuncture for     treating vasomotor and other symptoms associated with menopause as acupuncture is generally     practiced in the real world setting and to obtain a comprehensive assessment of use     patterns and symptom relief over time. This study will allow us to determine treatment     patterns recommended by practicing acupuncturists, adherence to these treatments, and the     effectiveness of different treatment patterns for reducing hot flashes. Results of this study     will provide meaningful information to women in terms of number and frequency of acupuncture     treatments likely to be needed to reduce hot flashes.   "
153390|NCT01276015|"     Objectives. To study the short-term neurophysiological and clinical outcome of botulinum     toxin type A(BoNT-A), injected at standard doses, and assess toxin spread to neighboring     uninjected muscles in children with cerebral palsy.      Subjects and methods. The investigators studied 18 ambulatory children with dynamic equinus     foot deformity (mean age 6.1 years). The gastrocnemius muscle on the affected side was     injected with BoNT-A (Dysport, range from 8.9-19.4 U/kg). As the primary neurophysiological     outcome measure, compound muscle action potential (CMAP) areas were assessed in the lateral     gastrocnemius (LG) and tibialis anterior(TA) muscles on the treated and untreated side before     BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections. Clinical scales     were assessed and video gait was analyzed at all three time points.      Results. In all patients, CMAP areas recorded from the LG and TA muscles on the treated side     decreased significantly from pre-injection values at T10 (p<0.05) and T30 (p<0.002).     Assessment at both time points after injections also showed that ankle spasticity had     diminished (p<0.05), equinus foot excursion increased (p<0.05), and functional gait improved     (p<0.05).      Conclusion. Although BoNT-A injected at standard doses improves gait in children with spastic     equinus foot the toxin spreads to uninjected leg muscles. BoNT-A treatment for cerebral palsy     therefore needs individualizing according to the child's clinical features.   "
153391|NCT01276002|"     The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and     persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized     studies have been conducted on the influence of pancreatic duct stenting for the patients`     benefits and recurrence rates. The aim fo this study is therefore to evaluate prospectively     in a randomized, controlled fashion in patients wit pancreatic pseudocysts, wether pancreatic     duct stenting of a disrupted pancreatic duct is beneficial in terms of quicker clinical     recovery and avoidance of recurrence of pancreatic pseudocysts.   "
153392|NCT01275989|"     Randomized Controlled Trial found that levels of stress and anxiety of students ITIO, Ear and     effective in reducing these levels. The LSS questionnaire and IDATE state were applied     before, two months and two and a half months after the start of the applications, the STAI     trait was applied once prior to the sessions. The sample comprised 56 individuals who had     higher levels of stress above the average LSS 100 students who answered the questionnaires.     Participants were divided randomly into three groups: control group with 15 patients without     care, intervention group with 20 individuals using specific points for treatment and Group     Sham at 21 points using individuals without indication for treatment of anxiety and stress.     The results showed that the sham points decreased anxiety levels of participants.   "
153393|NCT01275976|"     Trauma and major operation are associated with an excessive inflammation reaction due to     tissue injury. This overwhelming immune response is considered to be a major risk factor in     the pathogenesis of late inflammatory complications such as acute respiratory distress     syndrome (ARDS), multiple organ dysfunction syndrome (MODS) and sepsis.      The investigators hypothesize that administration of C1-esterase inhibitor (C1-INH) will     attenuate the humane inflammatory response and, thereby, reduce the risk of inflammatory     complications due to surgical interventions in trauma patients with a femur or pelvic     fracture   "
153394|NCT01275963|"     Assessment of left ventricular systolic function is the most frequent indication for routine     echocardiography. Qualitative eyeball method and biplane modified Simpson's rule, both     measuring radial ventricular function, are the currently recommended methods to meet this     challenge. Due to the complexity of the myocardial architecture, global left ventricular     function also has longitudinal and torsional components.      The aim of this study is to evaluate new echocardiographic parameters for longitudinal left     ventricular function. A special focus is set on strain imaging by speckle tracking, which is     a relatively new technique. Patients with different cardiac pathologies (e. g. dilated     cardiomyopathy, coronary artery disease, diastolic dysfunction) will be included and compared     to healthy individuals.   "
153395|NCT01275950|"     The Project aims at enlisting the outlets selling tobacco in any form and enlisting the     tobacco based advertisements (Direct and Surrogate) directed towards the community, within     100 yards of the selected educational institutes and studying their impact on the students of     that institute. This will further be followed by an intervention program directed at the     outlet owners which entails creating awareness about the harmful effects of tobacco and the     existing bill and thereby assessing any change in Knowledge, Attitude and Practice. The     results thus obtained will facilitate implementation of the existing Bill.   "
153528|NCT01274221|"     The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo     in adolescent subjects (13-17 years of age inclusive) with ADHD in the analog classroom     setting based on the Permanent Product Measure of Performance (PERMP) total score assessed     across 2, 4, 9, 13, 14, and 15 hours post-dose on the last day of each double-blind crossover     period.   "
153396|NCT01275937|"     A bleeding peptic ulcer remains a serious medical problem with significant morbidity and     mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality     in patients with bleeding peptic ulcers and is now recommended as the first hemostatic     modality for these patients.      In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after     endoscopic therapy has been endorsed in some studies. However, low dose of PPI has also been     supported in the management of these patients.      The investigators enroll 130 patients with active bleeding or nonbleeding visible vessels in     this study. They are randomly assigned as 40 mg/day or 160mg/day IV nexium group. All     patients receive successful endoscopic therapy with heater probe or hemoclip placement.      In the low dose group (N=65), 40 mg IV Nexium daily is given for three days. Thereafter, the     patients receive 40 mg nexium orally daily for two months. In the large dose group (N=65),     160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40     mg nexium orally daily for two months.      The primary end point is recurrent bleeding before discharge and within 14 days. At day 14,     volume of blood transfused, number of surgeries performed, and the mortality rates of the two     groups are compared as well.   "
153397|NCT01275924|"     Syndesmotic injuries are common and often associated with unstable ankle fractures. The most     common treatment is with a syndesmotic screw through the fibula and tibia which is later     removed, usually after 10-12 weeks. The Tightrope Syndesmosis Repair Kit (Arthrex; Naples,     Florida). is used for the same indication, it consists of a heavy suture placed across the     syndesmosis which has been looped and tightened through cortical button anchors on either     side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial     compares these two treatment methods for syndesmotic injuries of the ankle.   "
153398|NCT01275911|"     In this randomized observer-blinded trial the analgesic efficacy of intravenous esmolol, as     alternative to intraoperative opioids, is tested in patients undergoing laparoscopic     prostatectomy and upper gastrointestinal surgery (such as Nissen fundoplication). The purpose     of this study is to determine whether intravenous esmolol improves postoperative analgesia     and accelerate the surgical recovery. We hypothesize that patients receiving intravenous     esmolol will consume less analgesic in the postoperative period, will have less     opioid-related side effects and will recover their functional status faster then patients     receiving intravenous esmolol.      Patients will be stratified according to the type of surgical procedure in 2 arms: 40     patients with prostate cancer and undergoing elective laparoscopic prostatectomy, and 40     patients with gastro-esophageal reflux undergoing upper gastrointestinal surgery (Nissen     funduplication) will be enrolled.      Patients will receive total intravenous anesthesia with propofol and esmolol (Esmolol group,     n=20 in each arm) or propofol and remifentanil (Remifentanil Group, n=20 in each arm).   "
153399|NCT01275898|"     Cerebral oxygenation can be monitored using near infrared spectroscopy. Different devices are     available to assess cerebral oxygenation noninvasively. Beach chair position is assumed to     influence cerebral oxygenation. Litte is known about the influence of prone position and head     down position on cerebral oxygenation. The investigators hypothesize that these positions     influence cerebral oxygenation. Further the investigators presume that the two cerebral     oximeters INVOS and ForeSight provide comparable oxygenation data.   "
153400|NCT01275885|"     The aims of the present study are to evaluate the concentrations of vitamin D in the plasma     and of calcium in the plasma and in the urine as well as to evaluate bone mineral density     using peripheral quantitative computed tomography (pQCT), after supplementation of vitamin D     with 30µg (1200 IU) and 40µg (1600 IU), in comparison with currently recommended     supplementation of vitamin D with 10µg (400 IU). In this pilot study supplementation is given     to infants from 2 weeks of age to 3 months of age.   "
153401|NCT01275872|"     The purpose of this study is to determine whether Guided Imagery and Progressive Muscle     Relaxation techniques are effective in the management of pain, fatigue, nausea-vomit, anxiety     and depression in patients with either prostate or breast cancer.      This study includes a total of 200 patients with prostate and breast cancer randomly assigned     to either a control or intervention group.      The intervention group received in total 4 sessions of Guided Imagery (protocol floating on a     cloud) and Progressive Muscle Relaxation (breathing exercises and use of 11 groups of muscle     progressively tensing and relaxing).      Measurements included the assessment of pain, fatigue, nausea-vomit, depression, anxiety and     quality of life. Additionally, saliva samples were collected prior and after the sessions as     to assess saliva cortisol and saliva α-amylase.      The same measurements were received by the patients of the control group as to allow     comparisons.   "
153402|NCT01275859|"     Cross-talk between epidermal growth factors and the ER occurs at multiple levels and seems to     play a crucial role in breast cancer progression and endocrine resistance.Combined     HER1/HER2-targeted therapy with aromatase inhibitors for ER-positive and HER-2 positive     postmenopausal breast cancer might enhance response and block emergence of endocrine     resistant tumor.   "
153403|NCT01275846|"     This purposed of this study is to ascertain if the implementation of remote patient     management systems utilizing American Heart Association (AHA) guideline-based heart failure     protocols and educational content can improve the management of patients with congestive     heart failure.   "
153404|NCT01275833|"     The objective of the trial is to observe the effects of restoring atrioventricular (AV)     synchrony in subjects with prolonged PR intervals. This will be assessed both acutely and     chronically using echocardiographic and functional measurements.   "
153405|NCT01275820|"     The purpose of this study is to evaluate how an investigational food product affects a     healthy person's blood sugar and insulin levels.   "
153406|NCT01275807|"     The purpose of the investigators study is to create the evidence of effectivness on     climacteric syndrome in patients affected by breast cancer, by acupuncture added to the     standard care (self care).   "
153407|NCT01275794|"     The purpose of the study is assessment of glycemic control and physicians satisfaction with     results of DM2 OAD monotherapy   "
153408|NCT01275781|"     The purpose of this study is to assess distribution, metabolism, and excretion of     radio-labelled AZD9742 administered as a 2-hour infusion to healthy male volunteers.   "
154390|NCT01262989|"     It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments,     02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions     receive, in each period, the test formulation or the reference formulation   "
153409|NCT01275768|"     Patients with malignant obstructive jaundice (cancer of head of pancreas and     cholangiocarcinoma) generally have a very poor prognosis with less than 20% patients having     resectable disease at presentation. These patients also have a very poor quality of life with     a life expectancy of 6-8 months. Jaundice associated with pruritus, poor appetite,     malabsorption and loss of weight and cholangitis is the most common and troublesome problem.     Placement of metallic stents has been the standard of care for patients with unresectable     disease. However, about 50% of these stents get blocked in 6-8 months. Use of endoscopic     Radio-frequency Ablation (RFA) prior to placement of metal stents may increase the patency of     these stents   "
153410|NCT01275755|"     Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and     reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI     tract. The most common symptoms associated with the effects of opioids are constipation and     nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of     long-term opioid therapy.      The primary objective of this study was to compare ADL5945 once daily, a MOR antagonist, with     placebo in the treatment of opioid-induced constipation (OIC) in adults taking long-term     opioid therapy for chronic noncancer pain.   "
153411|NCT01275742|"     Heart failure (HF) affects 5 million people in the US and is the most common cause of     hospitalization in elderly adults. One-third of patients who are hospitalized with HF have     major depression. Depressed HF patients have double the rates of morbidity and/or mortality     and worse health-related quality of life than non-depressed HF patients. The investigators     previous pilot research suggests that a brief Cognitive Therapy (CT) intervention may improve     short-term cardiac survival among depressed hospitalized HF patients compared to     non-depressed HF patients who received usual care. Therefore, the investigators will conduct     a larger study to evaluate the effects of the intervention on longer cardiac event-free     survival, symptoms of depression, health-related quality of life, and stress levels in     patients with HF. The investigators hypothesize that patients in the intervention group will     experience longer cardiac event-free survival, lower levels of depressive symptom, better     health-related quality of life, and lower salivary cortisol levels at follow-up than patients     who receive usual care.   "
153412|NCT01275729|"     The primary objective is to safely determine if the investigators can identify the severity     of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled the     investigators will draw blood and urine for novel and standard biomarkers. The investigators     are attempting to determine if these biomarkers can forecast the course of AKI (need for     dialysis, death and renal recovery). The investigators seek to determine how well physicians     caring for those with AKI can predict the clinical course compared to these novel biomarkers     of AKI and if there is an association between clinical course and 3 year patient outcomes.   "
153413|NCT01275716|"     Subjects in this research study have Coronary Artery Disease (CAD). This occurs when there is     a build-up of fatty material in the wall of the heart arteries that causes narrowing of the     arteries. This could lead to chest pain, a heart attack, weakening of the heart and/or     permanent damage to the heart. As part of their normal routine care, subjects had or will     have a Percutaneous Coronary Intervention (PCI) to restore the blood flow in the arteries of     their heart. During a PCI procedure, pictures are taken of the arteries before and after the     treatment of the narrowing in the arteries. These pictures are acquired through angiography     which is a way to produce X-ray pictures of the inside of arteries.      After a PCI procedure, there is a possibility for narrowing of the arteries to return. The     likelihood of this happening can be greatly reduced by lifestyle changes and adhering to     heart medication regimens. It is part of normal, routine care for CAD patients to be given     written and verbal information on how to lead a heart healthy lifestyle and to take heart     medications properly.      In this research study, the investigators will show half of the patients their before and     after images of their heart arteries where the narrowing occurred and was treated. The other     half of the patients will not be shown these images. Both groups will still receive     information about lifestyle and medications as part of their normal, routine care. At the end     of this study, the investigators will compare both groups to see if there are any differences     in making lifestyle changes and taking heart medications properly. Additionally, the     investigators would also like to see if there are any resulting differences in the amount of     hearts attacks or other heart related medical events.   "
153414|NCT01275703|"     Subjects in this study have been diagnosed with pulmonary hypertension and their doctors have     referred them for an exercise test as part of their normal, routine care. The exercise test     will either be a treadmill test or a 6 minute walk test. During a treadmill test, a patient     typically walks on a treadmill while their heart is monitored using an electrocardiogram,     which records the electrical activity of the heart through 10 small electrode patches     attached to the skin of the chest, arms and legs. Additionally, heart rate and blood pressure     are monitored throughout the test. A 6-Minute Walk test requires patients to walk for up to 6     minutes to determine how far they can go in order to measure the heart function related to     exercise.      The purpose of this study is to measure internal heart pressures using a device called     Noninvasive Cardiac Output Monitoring (NICOM) during an exercise test. Normally heart     pressures are measured during invasive (meaning that doctors have to go inside the body using     a needle or surgery) heart procedures. The NICOM device is non-invasive which means the     investigators do not have to go inside the body to obtain the heart pressure measurements. In     this study, the investigators will evaluate the non-invasive measurements provided by the     NICOM device during the exercise test and see how it relates to information from some of     subjects' past heart procedures. This research is being done to devise better, less invasive     ways to assess disease severity, track disease progression and evaluate response to therapy.      The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart     pressures. This device is usually used when a patient can't undergo a right heart     catheterization. In this study, the investigators are using the device to gather heart     pressure measurements for research during the exercise test that is scheduled as part of the     subjects' normal, routine care. The research data is being used to devise better, less     invasive ways to assess disease severity, track disease progression and evaluate response to     therapy. The NICOM device is made by Cheetah Medical.   "
153415|NCT01275690|"     Subjects in this study have been diagnosed with pulmonary hypertension (PH) and their doctors     have referred them for a right heart catheterization (RHC). Heart catheterization involves     inserting an IV (a needle with a small tube) into a vein in the neck. A long, narrow tube,     called a catheter, is guided through the IV into the blood vessel and guided to the heart     (sometimes this procedure can be done through a vein in the groin instead). Once the catheter     is in place, small instruments can be inserted into the catheter to measure the pressures in     different areas of the heart. These measurements can help the doctor diagnose possible     problems with the heart functioning.      The purpose of this study is to evaluate the measurements provided by a device, called     Noninvasive Cardiac Output Monitoring (NICOM). The NICOM device is non-invasive which means     the investigators do not have to go inside the body to obtain the heart pressure     measurements. While the device has been approved for use in any patient, it remains possible     that patients with PH will have differences in the way the device calculates measurements. In     this study, the investigators will compare the in-the-body (right heart catheterization)     measurements to the non-invasive, outside-body measurements provided by the NICOM device to     evaluate any differences.      The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart     pressures. This device is usually used when a patient can't undergo a right heart     catheterization. In this study, the investigators are using the device to gather heart     pressure measurements for research during the right heart catheterization procedure that is     scheduled as part of the patients' normal, routine care. The research data is being used to     devise better, less invasive ways to assess disease severity, track disease progression and     evaluate response to therapy. The NICOM device is made by Cheetah Medical.   "
153417|NCT01275664|"     This clinical trial is studying how well granisetron, aprepitant, and dexamethasone work in     preventing nausea and vomiting in patients receiving chemotherapy for stage II, stage III, or     stage IV ovarian cancer. Granisetron patch, aprepitant and dexamethasone may help lessen or     prevent nausea and vomiting in patients receiving chemotherapy for stage II, stage III, or     stage IV ovarian cancer.   "
153418|NCT01275651|"     This research trial studies biomarkers in bone marrow and blood samples from patients with     prostate cancer treated with ketoconazole. Studying samples of bone marrow and blood from     patients with prostate cancer in the laboratory may help doctors learn more about changes     that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.   "
153419|NCT01275638|"     Despite the new developments in sepsis treatment, mortality rate is still high. Discussions     on steroid treatment in sepsis are going on. In this study, we aimed to investigate the     effects of moderate dosage steroid treatment and endocrinologic changes occurring in sepsis     on prognosis in patients with sepsis.   "
153420|NCT01275625|"     One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and     lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the efficacy     and safety of this combination in a Russian population of patients.   "
153421|NCT01275612|"     This is a pilot, explorative, study to test the feasibility and safety of systemic infusion     of donor ex-vivo expanded Mesenchymal Stem Cells to repair the kidney and improve function in     patients with solid organ cancers who develop acute renal failure after chemotherapy with     cisplatin.   "
153422|NCT01275599|"     The purpose of this study is to investigate the drug-drug interaction potential between     telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will     help to determine whether buprenorphine dose adjustments are necessary for patients who are     concomitantly treated with telaprevir.      Telaprevir, in combination with other antiviral agents, is being investigated for the     treatment of chronic hepatitis C virus infection. Buprenorphine/naloxone is used for     maintainance therapy in patients with opioid dependence.   "
153423|NCT01275586|"     The purpose of this Pilot Study is to determine if NF1 patients with plexiform neurofibromas     treated with Tasgina® respond to therapy.   "
153424|NCT01275573|"     Pain is a frequent symptom in Parkinson's disease. Previous studies have shown that pain     perception was altered in Parkinson's disease patients and could be related to nociceptive     cortical area hyperactivation. Repetitive Transcranial Magnetic Stimulation is an     electrophysiological tool which can modify cortical excitability. Its efficacy was     demonstrated in neuropathic pain. This is a randomized, double blind cross-over study. In     this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be     evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain     free Parkinson's disease patients. Each group will receive a high frequency Repetitive     Transcranial Magnetic Stimulation and placebo stimulation in different order with a gap of     one week.      The investigators supposed that a 20 Hz Repetitive Transcranial Magnetic Stimulation session     with an infraliminary intensity on the primary cortical motor, modulating nociceptive     cortical areas activity, could modify the nociceptive threshold perception in Parkinson's     patients.   "
153425|NCT01275560|"     The objectives of this work are: 1/to estimate the frequency of a positive glucose breath     test in favour of a small intestinal bacterial overgrowth in a population of patients     consulting for gaz incontinence by comparison to a population of control subjects; 2/to     estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case     of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve gaz     incontinence   "
153426|NCT01275547|"     Introduction      Ketamine is an old and generally well accepted analgesic used in the intra- and perioperative     setting. Several studies demonstrated the effectiveness of ketamine in the postoperative     setting.      A new formulation of S-ketamine as an intranasal spray device was tested in our hospital in 8     healthy volunteers (unpublished data, EKBB 351/08). 20 mg of S-ketamine were administered     intranasally and compared with S-ketamine i.v. and i.m.. None of the volunteers had serious     adverse effects or complications. A preliminary data analysis shows a clear analgesic effect     and good absorption of the intranasal S-ketamine.      As a next step we would like to investigate the effect of S-ketamine intranasal spray     combined with midazolam intranasal spray in a group of postoperative spinal surgery patients.     The rational for the combination of intranasal S-ketamine and midazolam is the well known     midazolam antagonising effect of ketamine induced psychomimetic adverse effects. Furthermore     we know from other studies (EKBB 106/06) that midazolam intranasal spray has relaxant and     anxiolytic effects. As far as we know, this is the first study which will examine the     combination of S-ketamine and midazolam intranasal sprays in adult patients.      Study work plan      This prospective, randomized, double-blinded non inferiority study will address pain ratings     and patient satisfaction in a postoperative setting in two treatment scenarios:        1. Alternating S-ketamine intranasal unit-dose spray (6 mg per dose) with midazolam          intranasal spray (0.75 mg per dose) patient controlled application with a lock-out          interval of 20 minutes between two applications and placebo patient controlled analgesia          (PCA) with a lock-out interval of 12 minutes with saline 0.9% i.v. for 72 hours or until          40 unit-dose sprays are delivered        2. PCA with 2 mg morphine with a lock-out interval of 12 minutes i.v. with placebo          intranasal spray (saline 0.9% + chitosan) with a minimum lock-out interval of 20 minutes          for 72 hours or until 40 unit-dose sprays are delivered      Patient number      We will examine 36 patients, 18 patients in each group. The study duration for an individual     patient will be at latest 72 hours, the total study duration is 4 to 5 months.      Study importance      An intranasal spray is an ideal application form for surgery patients, either in- or     outpatients. On the other hand, ketamine and S-ketamine is quite often used in the     perioperative setting as a rescue analgesic. In higher doses it could be used as an emergency     tool in emergency prehospital medicine. In the perioperative setting it is important to     evaluate the efficacy and safety of S-ketamine intranasal spray combined with midazolam     intranasal spray in patients.      If our study shows that S-ketamine intranasal spray is effective as an analgesic and has good     patient acceptance, S-ketamine intranasal spay could be considered as an alternative,     completely non-invasive analgesic procedure in a postoperative outpatient setting. As a     consequence development of a nasal multidose-applicator combining S-ketamine and midazolam     would be of interest.   "
153439|NCT01275378|"     The purpose of this study is to compare the effectiveness of two care models on ADHD     outcomes: one, a model of basic care management and structured communication with     specialists, consistent with conventional descriptions of a patient-centered Medical Home;     and another, which combines the Medical Home with theory-based care management strategies to     address common reasons for ADHD treatment failure.   "
154410|NCT01262729|"     In this clinical trial will be checked, whether 2 hour ventilation with xenon has     neuroprotective effects in patients with out of hospital cardiac arrest and successful     cardiopulmonary resuscitation   "
153427|NCT01275534|"     In the study PROVIVO, a patient reported outcome instrument consisting of items from the     PRO-CTCAE item bank measuring symptom experience of long-term survivors after allogeneic     hematopoietic stem cell transplantation (SCT) will be developed. The instrument development     is based on cognitive patient interviews, a survey of hematology experts and a literature     review. In a subsequent cross-sectional study phase, the instrument will be validated in a     sample of 300 allogeneic stem cell recipients and by the use of additional self report     instruments it will be possible to explore how subjective symptom experience, problems in     self-management and presence of late effects are connected.   "
153428|NCT01275521|"     BPH is very common in elderly men, it is a stromal as well as epithelial invasion of the     prostatic gland. Due to an imbalance between growth and apoptosis cellular mechanisms that     are not fully elucidated. It is the same for symptomatology and urodynamic obstruction     without clear identification of the part which is due to static phenomena (volume increase)     and dynamic reports (α 1-receptor action). That explains the multiplicity of treatments and     the difficulty of therapeutic indications between monitoring, medical treatment, and surgical     operation. Experimental studies of BONT-A intra prostatic injection on animal and human     models, have shown efficacy in BPH cell apoptosis, decrease in cell growth and decline in the     number of adrenergic α1 receptors.      Many studies in humans show therapeutic efficacy leading to a possible use of BONT-A as mini     invasive treatment of symptomatic BPH, as an alternative to medical or surgical treatment.      PROTOX study proposes to evaluate tolerance and effectiveness of the intra-prostatique BONT-A     injection in the treatment of symptomatic BPH.   "
153429|NCT01275508|"     The scientific objective of the project is to evaluate if the topical administration of     Fluoresceinisothiocyanate (FITC)-Adalimumab during the endomicroscopic examination of the gut     in Crohn's disease (CD) patients shows an acceptable safety profile. Another objective is to     explore whether the use of FITC-Adalimumab as a predictive biomarker might reliably predict     patient response to Adalimumab therapy and hence enable optimized utilization of this     treatment option.   "
153430|NCT01275495|"     The purpose of this study is to test the efficacy of the revised Telephone Assessment and     Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR)     intervention in family caregivers of stroke survivors. We will also test if TASK II     intervention effects on primary outcomes (depressive symptoms, caregiving-related negative     life changes, unhealthy days) are mediated through effects on secondary outcomes (task     difficulty, optimism, threat appraisal). Comparative costs and outcomes for the TASK II and     ISR interventions will also be explored.   "
153431|NCT01275482|"     The purpose of this study is to determine whether Transverse Friction Massage (TFM) in Latent     Myofascial Trigger points (MTrP) is more effective making this technique in two different     ways.   "
153432|NCT01275469|"     The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in     improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and     abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of     oral doses of GFT505 during 35 days.   "
153433|NCT01275456|"     This clinical validation study is aimed at testing the efficacy of a new environmental     challenge chamber (ECC) to induce symptoms of allergic rhinitis in patients allergic to house     dust mite. The symptoms will be recorded on a validated symptom score as Total Nasal Symptom     Score (TNSS), allowing for determine whether the challenge is dose dependent and     reproducible.   "
153434|NCT01275443|"     TMC278 (also called rilpivirine) is a new drug being developed to treat HIV. Usually TMC278     is taken as a tablet, by mouth, once a day, but a 'long acting' formulation has been     developed so the drug stays in the bloodstream for a longer time - this allows the drug to be     given by injection and less often. It is hoped that this injectable version of the drug may     be used to help prevent HIV transmission in the future by giving it to people who are at risk     of HIV. This is similar to the way travellers to areas with malaria may take antibiotics to     prevent infection. The investigators aim to investigate the feasibility of using TMC278 as a     preventative medication by performing this study.      The purpose of this study is to investigate the levels of drug which can be measured in the     blood, as well as the tissues and fluids of the rectum (the lowest part of the bowels just     before the opening of the anus) as well as the safety of the drug and how well tolerated it     is when given as a single dose. In this study, the investigators will not be investigating     whether the drug prevents HIV so the investigators will recruit people who are HIV negative,     and whose lifestyle does not put them at risk of becoming infected before or during the     study.      If the study shows the drug is well tolerated and produces appropriate levels of the drug (in     the bloodstream and the rectal compartment) to suggest that it could be effective, it will     help design future studies looking at preventing HIV.   "
153435|NCT01275430|"     Phase I        -  determine the location of the peripherally inserted central catheter (PICC) tip upon          observation of maximum p-wave amplitude      Phase II        -  determine the precision of PICC placement in the Sherlock 3CG group versus the standard          PICC placement   "
153436|NCT01275417|"     We are expecting that there are remarkable differences location at BaiHui(GV20) or     Houding(GV19)showing from same person in our study.   "
153437|NCT01275404|"     The investigators know that treatment for prostate cancer and erectile dysfunction can impact     sexual health and quality of life. They want to learn how the treatment affects one's     emotional and social well-being.      They have developed a new type of counseling. Cancer patients seek counseling for lots of     reasons. It often helps them cope because they can express their feelings with a trained     professional. They hope that this counseling will teach patients skills that they can use to     comply with erectile treatment programs, improve their sexual health and quality of life.     These skills may also improve physical and emotional well-being. As part of this study they     will ask the patient to provide feedback on the proposed counseling.   "
153438|NCT01275391|"     In this project we will conduct a pilot study of a brief intervention to reduce teen tobacco,     alcohol and drug use that primary care dental practitioners can provide in their offices.   "
153440|NCT01275365|"     This will be a randomized, placebo-controlled, parallel group, double blind, clinical trial     in community dwelling, older men, 65 years of age or older, who have mobility limitation and     low protein intake. The study will have a 2 X 2 factorial design, which will allow us to     investigate the effects of dietary protein intake and testosterone separately and together.   "
153495|NCT01274650|"     Patient nutritional needs vary depending on several factors including age, sex, height,     weight, injury and co-morbidities. Since injury affects energy expenditure in patients, this     must be taken into account when assessing nutritional requirements. Indirect calorimetry will     be used to measure energy expenditure of patients with decubitus ulcers of varying degrees.     The primary objective of this study is to determine the effects of wound volume on metabolic     rate and compare this to predictive equations used for estimating energy requirements.   "
190169|NCT00334633|"     We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than     treatment with metronidazole   "
153441|NCT01275352|"     This study will consist of middle-aged Caucasian non-failing subjects with high blood     pressure who are homozygous for a gene that confers increased risk of developing heart     failure, the Glycine 83 variant of the Ka renal chloride channel (ClC-Ka Gly/Gly 83), or     middle-aged Caucasian non-failing hypertensive subjects who lack the heart failure risk gene,     the wild-type Arginine 83 Ka renal chloride channel (ClC-Ka Arg/Arg 83). Subjects on standard     therapy for high blood pressure with an angiotensin converting inhibitor (ACEI) or     angiotensin receptor blocker (ARB) will be randomized to additional treatment with eplerenone     (an aldosterone antagonist) or placebo, and assessed for changes in echocardiographic left     ventricular hypertrophy (LVMI). Secondary endpoints will assess left ventricular remodeling     and other echocardiographic variables. The investigators hypothesize that subjects homozygous     for the CLCNKA risk allele will have a greater response to eplerenone in terms of reductions     in LVMI than those lacking the risk allele.   "
153442|NCT01275339|"     Currently, aortic stenosis (AS) is considered a surgical disease with no medical therapy     available to improve any clinical outcomes, including symptoms, time to surgery, or long-term     survival. Thus far, randomized studies involving statins have not been promising with respect     to slowing progressive valve stenosis. Beyond the valve, two common consequences of aortic     stenosis are hypertrophic remodeling of the left ventricle (LV) and pulmonary venous     hypertension; each of these has been associated with worse heart failure symptoms, increased     operative mortality, and worse long-term outcomes. Whether altering LV structural     abnormalities, improving LV function, and/or reducing pulmonary artery pressures with medical     therapy would improve clinical outcomes in patients with AS has not been tested. Animal     models of pressure overload have demonstrated that phosphodiesterase type 5 (PDE5) inhibition     influences nitric oxide (NO) - cyclic guanosine monophosphate (cGMP) signaling in the LV and     favorably impacts LV structure and function, but this has not been tested in humans with AS.     Studies in humans with left-sided heart failure and pulmonary venous hypertension have shown     that PDE5 inhibition improves functional capacity and quality of life, but patients with AS     were not included in those studies. The investigators hypothesize that PDE5 inhibition with     tadalafil will have a favorable impact on LV structure and function as well as pulmonary     artery pressures. In this pilot study, the investigators anticipate that short-term     administration of tadalafil to patients with AS will be safe and well-tolerated.   "
153443|NCT01275326|"     Outbreaks of emerging and re-remerging infectious diseases are frequently reported     internationally in recent years, mainly due to global climate change, close human-livestock     contact in developing countries, and globalization. Thus prevention, monitoring and control     of infectious diseases are in urgent need to protect public health. High exposure risk to     various infectious agents in health care facilities is of special concern, especially to     airborne and droplet-borne respiratory diseases. To protect the health of public and health     care workers the investigators will conduct a study to monitor indoor air quality and     essential infectious aerosols in hospital(s).      A questionnaire survey will be used to evaluate the relationships between employees' health     and measured indoor environmental factors. The investigators will also examine whether the     current indoor air quality recommendation of their country can reasonably reduce the risk of     hospital infection. In addition, simple infectious aerosol indices will be established for     future environmental management and monitoring in health care facilities.   "
153444|NCT01275313|"     The proposed clinical trial is aimed at demonstrating the important role wheelchairs play in     preventing pressure ulcers (bed sores). Although most pressure ulcers can be prevented, they     are common in nursing home settings because their causes are difficult to identify. This     clinical trial will guide practitioners toward improving preventive care practices by     demonstrating how to effectively apply wheelchair and seat cushion technology.   "
153445|NCT01275300|"     We would like to see if aspirin could block niacin-induced flushing by analyzing blood and     urine after taking aspirin.      Phase I: 5 days of 81 mg aspirin/placebo followed by 600 mg Niacin, 2 week washout and 5 days     taking the alternate. The order in which this is given will be randomized or assigned by     chance.      Phase II: One study week consisting of 5 days of taking 81 mg Aspirin, taken once daily,     followed by a single dose of 600 mg Niacin on day 6.      Phase III: 5 days taking 81 mg Aspirin/placebo, 10 day washout in between.      Phase IV: Use of extended release niacin instead of instant release.      Phase V: A Celebrex study is necessary to explore the contribution of Cox-2 to niacin induced     flushing.   "
153446|NCT01275287|"     The purpose of this research study is to see if Eculizumab (Soliris®) can safely be used in     addition to conventional therapy in patients with active ANCA (Antineutrophil Cytoplasmic     Autoantibodies ) vasculitis and lead to a more rapid decrease in disease activity.      ANCA vasculitis is an inflammation of the small vessels whereby ANCA antibodies     inappropriately activate one's own white blood cells (neutrophils) and cause damage to the     small blood vessels.   "
153447|NCT01275274|"     The purpose of this research study is to learn if adding all-trans retinoic acid (tretinoin)     to conventional treatment of Anti- Neutrophil Cytoplasmic Autoantibodies (ANCA) vasculitis     can decrease the level of disease activity.   "
153448|NCT01275261|"     The purpose of this study is to determine whether bladder catheterization can be safely     avoided in patients admitted to the hospital with stroke using a nursing protocol, and     whether this decreases the incidence of urinary tract infections. The investigators     hypothesize that the protocol will be tolerated by nurses and patients, and that patients     without bladder catheters will have fewer urinary tract infections and better outcomes.   "
153449|NCT01275248|"     This study is to assess the efficacy and safety of two doses of ondansetron (0.5 mg and 0.75     mg) relative to placebo when administered twice daily as adjunctive therapy for adult     patients with Obsessive-Compulsive Disorder (OCD) who have not adequately responded to     treatment with a serotonin reuptake inhibitor (SRI).   "
153479|NCT01274858|"     The study will investigate topography of sensory changes late after lung cancer surgery   "
153480|NCT01274845|"     The aim of the study: to assess the effect of short-term mechanical ventilation with heliox     in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance     and respiratory function parameters.   "
153481|NCT01274832|"     The aim of this study is to investigate the impact of DBS not only no motor outcomes, but     also on neuropsychological and psychiatric aspects and on quality of life in young patients     with a short history of disease.   "
153450|NCT01275235|"     Individuals with a family history of type 2 diabetes mellitus (T2DM) are known to be at     greater risk for the disease, and studies have shown that how the body responds to insulin,     how the muscle creates energy, and the amount of fat stored inside skeletal muscle are often     different in these individuals at a young age compared to people without a family history of     the disease. The tendency to develop T2DM is influenced strongly by genetics; however,     exposure to the surrounding environment may also play a role. The exposure to a diabetic     environment while in the womb represents an altered nutritional exposure (high levels of     circulating sugar, or glucose) that may affect how tissues important in regulating energy     metabolism, such as the pancreas, liver, and skeletal muscle, develop. the purpose of this     study is to measure sensitivity to insulin, energy expenditure, fat content of the abdomen     and skeletal muscle function in young adult sibling pairs who were raised together but who     are discordant for intrauterine exposure to diabetes (i.e., the mother did ot have diabetes     during pregnancy with the older sibling, but did have diabetes during pregnancy with the     younger sibling).   "
153451|NCT01275222|"     This trial was a Phase I/II, non-randomized, open label, multi-center study, following a     sequential 2- part design. The first part, Phase I, was designed to assess whether there is a     pharmacokinetic interaction between Glivec/Gleevec (imatinib) and RAD001(everolimus) as well     as to collect safety data when these two drugs are co-administered. The second part, (Phase     II), was designed to assess the potential efficacy of the combination in imatinib-resistant     GIST patients in two strata of patients:        -  Patients resistant to imatinib as first-line drug therapy and in whom the maximum          tolerated dose was at least 600 mg/d (Stratum 1, first-line resistant/refractory)        -  Patients resistant to imatinib as well as to post-imatinib drug therapy (Stratum 2, post          second-line therapy).   "
153452|NCT01275209|"     This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with     bendamustine in patients with follicular lymphoma.   "
153453|NCT01275196|"     The study will compare the efficacy and safety of Nilotinib versus Imatinib in newly     diagnosed Chinese patients with CML-CP.   "
153454|NCT01275183|"     The proposed study is a first-in-human pilot of a novel anti-cancer strategy: Metnase     inhibition to potentiate DNA damaging chemotherapy. The investigators will conduct serial     tumor biopsies in subjects with HNSCC at three timepoints: baseline, after cisplatin, and     after cisplatin-raltegravir. The investigators will investigate immunohistochemical     expression changes of γH2AX, Chk2, and Annexin V, three biomarkers of DNA damage and     apoptosis. The study is designed to identify an intermediate signal of the potentiation of     cisplatin chemotherapy by raltegravir in HNSCC, which will justify a future phase I/II study.   "
153455|NCT01275170|"     Part I of this study will compare the pharmacokinetics of MK-7655, dosed in combination with     PRIMAXIN® (imipenem + cilastatin), in participants with impaired renal function and matched     control participants. In Part II of the study, the potential for renal insufficiency to     affect non-renal clearance mechanisms will be investigated.   "
153456|NCT01275157|"     This is a single dose study of radiolabeled [14C]-LY2452473 in healthy male volunteers to     study the absorption, distribution, metabolism, and elimination of LY2452473.      This study is for research purposes only and is not intended to treat any medical condition.   "
153457|NCT01275144|"     The purpose of this study is to determine how much lorazepam gets into the blood and how long     it takes the body to get rid of it when given together with LY2216684. Information about any     side effects that may occur will also be collected.   "
153458|NCT01275131|"     The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20)     will change the exposure and action of approved insulin analogs when given by continuous     subcutaneous insulin infusion (CSII) in participants with Type 1 diabetes mellitus (T1DM).      This study is divided into Stage 1, 2, and 3. Stage 3 was started chronologically before     Stage 2 and, prior to performing Stage 2, the Sponsor made the decision to terminate Stage 2.     Stage 2 was not initiated due to a strategic business decision and termination was not based     on safety or efficacy concerns. No participants were enrolled in Stage 2.   "
153459|NCT01275118|"     Comparison of postoperative visual acuity and spectacle independence between the Tecnis     Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL   "
153460|NCT01275105|"     The purpose of this study is to evaluate the safety, efficacy, and dose response of     brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of     allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.      It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more     effective than vehicle in the prevention of conjunctival redness induced by conjunctival     allergen challenge when instilled prior to the allergen challenge.   "
153461|NCT01275092|"     The objective of this study is to evaluate the safety and effectiveness of the clinical and     technical performance of the CorPath® 200 System in the delivery and manipulation of coronary     guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI).   "
153462|NCT01275079|"     The purpose of this study is to analyze the change of nasalance after tonsillectomy in Thai     adults.   "
153463|NCT01275066|"     This Phase 3 study will evaluate the efficacy and safety of 2.0 mg/kg/week BMN 110 and 2.0     mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A     Syndrome).      There is currently no standard accepted treatment for MPS IVA other than supportive care.     Enzyme replacement therapy (ERT) may be a potential new treatment option for MPS IVA     patients. BMN 110 is administered to MPS IVA patients by IV infusion, allowing cellular     uptake by the mannose-6-phosphate receptor and transportation to the lysosomes.      This enzyme uptake into the lysosomes is hypothesized to promote increased catabolism of     keratan sulfate (KS) in tissue macrophages, hyaline cartilage, other connective tissues, and     heart valve, and reduce the progressive accumulation of KS which is responsible for the     clinical manifestations of the disorders.   "
153493|NCT01274676|"     Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The     intra and/or postprocedural cerebral embolization remains the most frequent complication.     Thanks to the systematic use of cerebral protection systems, these complications have     reduced.A debate concerning which cerebral protective device should be more effective is     still ongoing.   "
153494|NCT01274663|"     The primary purpose of this study is to evaluate the safety, tolerability and     pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.   "
153464|NCT01275053|"     The purpose of this research study is to help us to better understand how leptin regulates     blood sugar levels. Leptin is a recently discovered hormone, which is made in fat cells.     Leptin is secreted by fat and acts as a signal to the brain to decrease appetite and     influences how the body regulates blood sugar levels. A synthetic form of leptin (A-100), an     investigational drug and has not yet been approved by the Food and Drug Administration (FDA),     will be administered to participants in this study. The expected duration of your     participation is 3 study visits, which will be spread over 3-4 weeks.      This study involves having fat and muscle biopsies after receiving leptin under local     anesthesia in the General Clinical Research Center (GCRC), surgical unit, and/or     Endocrinology exam room at the Beth Israel Deaconess Medical Center.   "
153465|NCT01275040|"     A pragmatic cluster randomised controlled trial will be done where the intervention will be a     mobile screening team visiting selected PHC facilities in Tshwane district. It will provide     education and screening for diabetic complications (foot, kidney, cardiac and retinal     complications). Six clinics will receive the intervention and six clinics will serve as     controls. Six hundred patients will be recruited (2 x 300).      The screening results will be evaluated by an expert panel at tertiary care level and an     individualised patient management plan will be compiled. This plan will be communicated to     the family physician and integration team at the clinic for further management or referral of     the patients. Laser therapy will be available on the mobile clinic for patients that require     it (as assessed by an Ophthalmologist who will review the retinal photos).      A baseline evaluation (including HbA1c, serum creatinine, lipogram and urine     albumin-creatinine ratio) will be done to determine current disease management at patient and     health facility level, followed by the intervention and a follow-up visit a year later. The     main outcome measures are glucose, lipid and blood pressure control as well as the percentage     of patients screened and referred for diabetes complications.      A cost effectiveness analysis will be done to estimate the added cost per added complication     prevented or referred.      The potential implications for improving diabetes care and preventing long term complications     are extremely important. The study results will be used to help plan future health care     services for people with diabetes mellitus in the region.   "
153466|NCT01275027|"     The purpose of this clinical research study is to evaluate the effects an investigational     food product has on the blood sugar and insulin levels in individuals with diabetes.   "
153467|NCT01275014|"     The aim is to compare the effectiveness of corticosteroid administration (dexamethasone) with     a placebo (saline), following arthrocentesis of for the temporomandibular joint (TMJ).     Twenty-eight participants with TMJ arthralgia, mainly related to osteoarthritis ae randomly     assigned to two arms of a parallel double blind RCT. In both arms an arthrocentesis procedure     is carried out, while a single dose intraarticular dexamethasone was delivered to     participants in one arm. Saline was delivered in the other arm to serve as a control. Follow     up visits were scheduled after 1, 3 and 24 weeks. During each visit TMJ pain (on a 100mm VAS)     and joint stiffness (mouth opening in mm) are scored. Generalized estimating equations (GEE)     are used for statistical analysis.   "
153468|NCT01275001|"     The purpose of this research study is to learn more about the effects a musical intervention     has on typical brain development in preschool-aged children.   "
153469|NCT01274988|"     Nucleus accumbens plays important roles in the process of opiate addiction and initial of     relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its     activity and thus to effectively prevent the relapse of the opiate dependence.   "
153470|NCT01274975|"     This study is designed to assess the safety of intravenous autologous adipose derived     mesenchymal stem cells transplant in spinal cord injury patients.   "
153471|NCT01274962|"     This study is proposed to evaluate whether giving part of the chemotherapy prior to     radiotherapy and surgery (as opposed to standard of care, which involves giving all the     chemotherapy after radiotherapy and surgery) for patients with node positive operable rectal     cancer will result in higher patient compliance to chemotherapy.   "
153472|NCT01274949|"     Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED     patients responding to PDE5i's. This study aimed to determine the capability of LI-ESWT to     affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor     therapy.   "
153473|NCT01274936|"     Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal     distribution. Cervical radiculopathy results from impingement on a nerve root by either     spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation.     Specifically, it should be the goal of the treating physician to relieve pain, improve     function, and prevent recurrence. Various studies have shown that nonoperative management of     cervical radiculopathy leaves a substantial minority of patients with persistently     troublesome symptoms. Pharmacologic agents treat the underlying condition and provide     symptomatic relief. The various classes of medications used to treat radiculopathy include     steroids, nonsteroidal antiinflammatory drugs (NSAIDs), muscle relaxants, narcotics, and     antidepressants. Herbal medicines have been used for centuries in China. In China, many     patients with cervical disc disease are increasingly turning to herbal medicines to alleviate     their symptoms and reduce the side effects of medications. The goal of this study is to     determine the efficacy and efficacy of an herbal medicine, Qishe Pill, to treat cervical     radiculopathy.   "
153474|NCT01274923|"     This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on     patients responding to PDE5i therapy in a sham controlled randomized double blind manner.   "
153475|NCT01274910|"     This is a single-center, prospective, randomized, double blind, placebo control study. The     aim of this study is to assess the effect of fish oil capsules on pain intensity and     postoperative analgesics consumption in patients after knee replacement surgery.      The study population will be adult are referred for knee replacement surgery due to     osteoarthritis of the knee.   "
153476|NCT01274897|"     This study is designed to evaluate the immunogenicity and the safety of a quadrivalent     vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.   "
153477|NCT01274884|"     Several surgical techniques are used for the treatment of acute acromioclavicular joint     dislocations. The investigators investigate a new method using arthroscopic repair using the     Tightrope fixation device.   "
153478|NCT01274871|"     Does chest drains contribute to the post thoracotomy pain syndrome   "
153482|NCT01274819|"     Rationale: Delirium is a frequently encountered problem in ICU patients and leads to     increased morbidity and mortality; Delirium in the ICU is associated with sleep deprivation     which is among others caused by a disrupted circadian rhythm; Dynamic Light application aims     at restoring a proper circadian rhythm by rhythmically alternating light intensity and has     shown beneficial effects in sleep quality. Whether DLA improves sleep quality and reduces     delirium incidence in ICU patients is not known      Goals/endpoints:      To evaluate the feasibility of dynamic light application in the ICU and to study the effects     of dynamic light application on the incidence of delirium, duration of mechanical     ventilation, the number of ICU and hospital days, and mortality in a mixed population of     medical and surgical ICU patients. In a subgroup of patients with a high risk of developing     delirium, markers of circadian rhythm, inflammation and brain damage and post ICU HRQoL will     be assessed Study design: prospective randomized single centre trial Study population: adult     ICU patients > 18 years old with an expected duration of stay of more than 24 hours     Intervention: Patients will be randomized between Standard Care or Standard Care + DLA; When     receiving standard care, normal lighting settings will be used in that patient room, which     can be controlled by the medical personnel; In the rooms of patients randomized to the DLA     group, DL is applied with a changing intensity during the day according to a fixed rhythm,     which is regulated centrally. In addition when necessary, an intervention light can be used     which can be operated in the patient room.      Study parameters/endpoints: incidence of delirium as measured by the CAM-ICU; duration of     mechanical ventilation, ICU and total hospital mortality; ICU and hospital LOS; Serum levels     of inflammatory markers and markers of brain damage, urinary levels of markers of circadian     rhythm, data of HRQoL questionnaires and total light exposure in both groups   "
153483|NCT01274806|"     Effectiveness of a physical therapy program focussed on core stability exercise and massage     as a recovery method in breast cancer survivors after oncology treatment.   "
153484|NCT01274793|"     the objective of this study is to investigate the Dose-Effect Relationship of Acupuncture     with Two-ways Regulation Effect to Treat Functional Enteropathy   "
153485|NCT01274780|"     This is a prospective, open controlled trial in which naïve HIV-1 patients will be randomized     to receive atazanavir / ritonavir or darunavir / ritonavir in combination with tenofovir /     emtricitabine. They will be followed up during 96 weeks to determinate the cholesterol     levels.      Randomization will be stratified according to the values of the ratio of total     cholesterol/HDL cholesterol obtained during the screening visit (as they will be <4.5 or ≥     4.5).   "
153486|NCT01274767|"     Low-dose aspirin is the mainstay of treatment for patients with coronary heart disease and     stroke. However, low-dose aspirin increases the risk of ulcer bleeding. Current evidence     indicates that 80 - 100 mg of aspirin daily provides good protection against vascular events     and the risk of ulcer bleeding is low (about 1% per year). Since the overall risk of bleeding     is low, aspirin users who do not have previous ulcer disease do not require prophylaxis with     anti-ulcer drugs. In contrast, aspirin users with a history of ulcer disease have a 2- to     4-fold increased risk of ulcer bleeding. The best strategy for reducing the risk of bleeding     in high-risk aspirin users remains unclear. Current strategies for high-risk patients include     the use of anti-ulcer drugs, elimination of risk factors (e.g. Helicobacter pylori), or the     use of enteric-coated aspirin.      Although co-therapy of aspirin with an acid suppressant reduces the risk of ulcer bleeding,     drug compliance may limit its clinical usefulness particularly in patients who are already     receiving multiple drugs. The efficacy of enteric-coated aspirin in preventing ulcer     complications showed conflicting results. One study found that enteric-coated aspirin     increases the risk of ulcer bleeding. A recent study showed that enteric-coated aspirin     causes minimal acute gastric injury.      The investigators postulated that among patients without H. pylori infection and a history of     ulcer bleeding who continue to use low-dose aspirin, enteric-coated aspirin reduces the     long-term risk of ulcer complications to a level that is comparable to that of average-risk     aspirin users.   "
153487|NCT01274754|"     Neurological complications occur in open heart surgery with a frequency of 40% and they range     from major neurological deficits (due to a stroke) to neurocognitive and behavioral     disorders. This study aims to determine if erythromycin, a worldwide known antibiotic,     protects the brain from damage when given in high doses before and during open heart surgery.      The investigators consume that high dose of erythromycin will protect the brain with a     pharmacological preconditioning against the global ischemia during the perioperative period     of heart surgery.   "
153488|NCT01274741|"     The purpose of this study is to determine if an integrated, cognitive-behavioral model of     psychotherapy is effective in the treatment of individuals with posttraumatic stress disorder     (PTSD) and substance use disorder (SUD) compared to a known evidence-based model for     PTSD/SUD.   "
153489|NCT01274728|"     This clinical evaluation will study the feasibility and safety of a CE-marked     paclitaxel-eluting balloon in primary PCI in patients with a STEMI. Drug eluting balloons     provide the potential advantage of delivering a anti-proliferative drug, without the     disadvantage of leaving a coronary stent, in STEMI patients treated with primary PCI.   "
153490|NCT01274715|"     The purpose of this study is to determine if behavioral health coaching for rural veterans     with diabetes and depression will improve self-management behaviors and lead to improvement     in diabetes care outcomes (e.g., HA1C) and improvement in reported depressive symptoms.   "
153491|NCT01274702|"     Incomplete remission after an optic neuritis attack is not uncommon. Visual reconstitution     therapy is a software-based approach that has been shown to substantially improve residual     visual field deficits in patients with pre- and postchiasmatic lesions.      The primary hypothesis of this randomized, controlled clinical trial is, that visual     reconstitution therapy is superior to active comparator treatment in improving the visual     field after optic neuritis.   "
153492|NCT01274689|"     The note re-introduces the external lid loading with the help of a lead weight for the     temporary treatment of lagophthalmos. Although simple and effective, the technique is rarely     used.Instead of wearing a monoculus, the patient uses an individually tailored lead weight     (0.8 mm thickness, 1.0 -2.0 g) sticked on the lid, it enables its closure. A spontaneous     ptosis indicates a too heavy weight. With the M. levator palpebrae intact, lid lifting is     possible. The effect is gravity dependent, so that the patient has to wear the monoculus at     night. To minimize the risk of lead intoxication, the surface of the weight is varnished. In     case of a persistent paresis of the M. orbicularis oculi an internal lid loading can follow.     A total of 152 lagophthalmos cases have been treated since 1997.All patients could close the     lid immediately. Almost half of the patients had to re-adjust the weight several times per     day due to hooded eyelids. The compliance was high, and a partial or complete restoration of     the function of the M. orbicularis oculi occurred in 60% of the cases. In some subjects, the     restoration of the M. orbicularis oculi was faster than of the M. orbicularis orbis. The     external lid loading for the temporary treatment of lagophthalmos is simple and effective.     Compared to a monoculus, the vision is unimpaired and the aesthetic is more appropriate for     most patients. The faster restoration of the M. orbicularis oculi hints at a potentially     facilitatory effect of the weight.   "
153498|NCT01274611|"     The purpose of this study is to compare the effectiveness of two methods in the treatment of     excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox injections.     Suction-curettage is a method in which the doctor will insert a suction tool into two small     incisions in order to suction out the sweat-producing glands. It is similar to liposuction,     but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where     the sweat glands are located. This method has been shown in some studies to effectively     reduce underarm sweating for months at a time. Botox is a Food and Drug Administration (FDA)     approved drug that in small doses, paralyses muscles. It is most commonly and famously used     in the treatment of facial wrinkles. However, it has also been approved to treat excessive     sweating. When injected in areas that sweat excessively, sweating can be significantly     reduced in that area for months at a time. This study is a pilot study designed to determine     feasibility of these procedures.   "
153499|NCT01274598|"     This is a phase I, open label clinical trial to evaluate the safety of Lactobacillus     rhamnosus GG (LGG) in elderly subjects. Lactobacilli are part of the normal flora of the     intestine. LGG is one of several strains of Lactobacilli that is used as a probiotic or     microorganism administered to confer health benefits. Our research is focused on studying     the possible therapeutic effects of LGG. The study hypotheses are:        -  LGG administered twice daily will be safe and well tolerated in elderly subjects        -  LGG will colonize the stool of elderly subjects and will modify the diversity and          richness of the microbiota in their nasopharyngeal and stool specimens   "
153500|NCT01274585|"     The primary objective of this study is to determine whether Percutaneous Tibial Nerve     Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of     patients with urinary incontinence, can also be used to treat fecal incontinence.     Specifically, the primary endpoint of this study is to determine, in a randomized controlled     patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in the     patients treated with PTNS when compared to placebo as documented by a 2 week patient bowel     diary after treatment.      The investigators secondary endpoints will consist of measurements of the impact of PTNS on     the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity     Index (FISI) score ), as well as on the patient quality of life factors related to fecal     incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL)     scale).   "
153501|NCT01274572|"     This study is being conducted to assess and monitor immune response in patients with     minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be     receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment     regimen.   "
153502|NCT01274559|"     This is a multicenter, randomized, double-blind, placebo-controlled study in participants     with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density     lipoprotein-cholesterol (LDL-C) to assess the efficacy and safety of extended release (ER)     niacin/laropiprant [ERN/LRPT (MK-0524A)] when added to the following ongoing lipid-modifying     therapy (LMT): simvastatin,      atorvastatin, rosuvastatin monotherapy, ezetimibe/simvastatin fixed dose combination (FDC),     or any statin co-administered with ezetimibe. The study is based on the hypothesis that     ERN/LRPT 2 g daily will be superior to placebo at lowering LDL-C at Week 12 of treatment.   "
153503|NCT01274546|"     The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data     on patients who received the cruciate-retaining Foundation Knee system during or prior to the     year 2000.   "
153504|NCT01274533|"     This is a research study for subjects who have been diagnosed with Adult T cell     Leukemia/Lymphoma, a rare and aggressive peripheral T cell neoplasm caused by the virus     HTLV1. Currently, there is no accepted standard therapy for this disease. The purpose of this     research study is to evaluate the use of the investigational drug lenalidomide in the     treatment of Adult T cell Leukemia/Lymphoma.      Lenalidomide is a drug that alters the immune system and it may also interfere with the     development of tiny blood vessels that help support tumor growth. Therefore, in theory, it     may reduce or prevent the growth of cancer cells.      Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of     specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for     patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM     are cancers of the blood. It is currently being tested in a variety of cancer conditions. In     this case it is considered experimental.   "
153505|NCT01274520|"     This is a study comparing a technique of continuous circulation to the liver as a means of     preventing liver damage during transportation to the transplant hospital. This new technique     of Machine Perfusion (MP) will be compared to the standard technique where the liver is     maintained in a bag of solution on ice without circulation. The investigators will evaluate     and compare the outcomes of the transplants with the new technique to the standard technique.     There will be 24 MP patient's in the study. The investigators have previously used this     technique with success in 20 human liver transplant patients. The investigators think there     will be a benefit in terms of less damage to and better function of the donor liver which     will result in faster recovery for the patients. This protective effect may allow us to     successfully transplant more patients and prevent people from dying while waiting for a liver     transplant.   "
153506|NCT01274507|"     The purpose of this study is to characterize the clinical, physiologic, and molecular     profiles of healthy participants, participants with mild, moderate, and severe asthma; and     participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).   "
153508|NCT01274481|"     This study will examine the hypothesis that iloprost maintains and improves ventilation     perfusion matching in patients with pulmonary hypertension and ARDS/ALI as reflected by 1) an     improved PaO2/FIO2 ratio as calculated from the measured arterial blood gases obtained before     and after iloprost administration, 2) an improvement in lung compliance, and 3) an     improvement in the ventilatory equivalents for oxygen and CO2 measured by expired gas     analysis.   "
153509|NCT01274468|"     The aim of this study is to determine if DCAMLK1 can be measured in the endobronchial biopsy     specimens and bronchial washings from patients with lung cancer.   "
153561|NCT01273792|"     Susac Syndrome is a rare disease and the establishment of the diagnosis is often difficult.     The aim of this investigation is to identify relevant biomarkers and to elucidate the     pathogenesis of Susac syndrome   "
153510|NCT01274455|"     Near 85% of patients with pancreatic adenocarcinoma are diagnosed with a locally advanced     and/or metastatic unresectable tumor. In these patients chemotherapy (such as gemcitabine) is     given as a palliative therapy. Aim of the present study is to evaluate the feasibility,     tolerance and antitumor effect of repeated intratumoral injection of a gene therapy product     (with antitumor and chemo sensitizing effects) combined with gemcitabine in patients with     unresectable pancreatic carcinoma.   "
153511|NCT01274442|"     Patients that may participate in this case-control study underwent dental implant surgery in     the University Hospital in Ghent in 2004-2007.      According to one of our recent papers based on this patient group, 34/461 patients lost one     or more implants. The goal is to invite these 34 patients, to update the anamnesis, to     perform a brief clinical oral examination and to have a blood sample. The latter is necessary     to identify relevant genetic polymorphisms of the patient that are associated with implant     loss. Among the remaining patients that did not lose implants, another 34 'controls' will be     invited for the same examinations.   "
153512|NCT01274429|"     The goal of this study is to produce a new treatment that would benefit adult subjects by     lowering the risk of anaphylactic reactions (desensitization), and changing the     peanut-specific immune response in subjects who have peanut allergy (tolerance). This project     is designed to study the innovative idea that oral immunotherapy (OIT), the ingestion of     small increasing amounts of food allergen, will desensitize subjects with peanut     hypersensitivity by regulating their mucosal and systemic immune reactivity and cause     long-term tolerance.   "
153513|NCT01274416|"     The investigators are trying to learn the most effective way to treat an adolescent's eating     disorder and how best to involve the parents or caregivers in this process.      Typically, parents and their child are seen together in therapy. However, this can sometimes     be difficult for both the parents and the adolescent. Both parents and adolescents have     different concerns and are struggling with different aspects of the eating disorder.     Therefore, the treatment in this study involves the parents in treatment, but does not have     therapy sessions with the parents and child together.      The purpose of this study is to develop this investigational type of treatment (separated     family treatment), and see what works best for adolescents and their families.      Participants meet with a therapist for 20 sessions over the course of 24 weeks. For the first     16 weeks families separate therapy sessions weekly. For the last 8 weeks families meet with     the therapist bi-weekly. These bi-weekly sessions are conjoint - that is, adolescents and     parents will meet with the therapist together. This is to help parents and adolescents come     together as a family to continue to aid the adolescent in the treatment of his/her eating     disorder.      The investigators hypothesize that adolescents who receive ASFT will demonstrate improvement     in eating disorder symptoms and body-mass index, that caregivers who participate in ASFT will     demonstrate decreased distress and caregiver burden, that increases in psychological     acceptance will be seen for both adolescents and caregivers post-treatment, and that     treatment will be viewed as both credible and acceptable to both caregiver and adolescent   "
153514|NCT01274403|"     The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus     meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients     with multiple myeloma but not eligible for high dose treatment with stem cells support.   "
153515|NCT01274390|"     This study is an ancillary (add-on) study to the clinical trial entitled Red Cell Storage     Duration Study (RECESS), which has clinicaltrials.gov identifier NCT00991341. The RECESS     study randomizes cardiac surgery patients to receive either red blood cell units stored for     no more than 10 days, or red blood cell units stored for at least 21 days, if they need any     red blood cell transfusions during their hospital stay for the surgery.      This ancillary study is entitled Impact of Blood Storage Duration on Physiologic Measures:     RECESS Ancillary Physiologic Study (RECAP). The hypothesis of the RECAP study is that there     will be differences between the two randomized treatment groups in how much the following     measurements change, from shortly before a red blood cell transfusion to shortly after a red     blood cell transfusion, and from before surgery to 24 hours after surgery:        -  Oxygen saturation in the hand        -  Oxygen saturation in the brain        -  Blood flow in the small blood vessels under the tongue.      The RECAP study will also investigate whether changes in the measurements listed above are     associated with clinical outcomes, including        -  The Multi-Organ Dysfunction Score        -  Death from any cause        -  Major cardiac events        -  Major pulmonary events   "
153516|NCT01274377|"     Human cytomegalovirus (CMV) is a benign infectious agent in the normal host, but in     immunocompromised individuals, such as recipients of stem cell transplants, this virus is a     major cause of morbidity and mortality. While pharmacologic agents exist to treat CMV     disease, these medications have numerous side effects, the most serious of which is     myelosuppression. The frequency of neutropenia ranges from 41% to 58% in stem cell transplant     (SCT) patients treated with ganciclovir. Withdrawal of anti-CMV therapy due to these     complications may result in recurrent disease. The restoration of cellular immunity to CMV is     necessary in order to prevent viral reactivation, and the generation of cytotoxic T cells     against CMV early antigens is perhaps the most important part of the host immune response to     CMV. At day 40 post-transplant, for example, at least 65% of SCT patients are deficient in     CD8+ T-cell responses to CMV. Previous studies have demonstrated a direct correlation between     CMV infection in these patients and cytotoxic T lymphocyte (CTL) function, with patients who     have defects in cellular immunity being at high risk for invasive CMV disease. The median     time post-transplant for the development of CMV disease is 50 to 60 days, and CMV     re-activation occurs in 70 to 80% of CMV sero-positive SCT recipients. Without anti-viral     therapy as many as 50% of these patients will develop CMV disease.   "
168573|NCT00034957|"     The primary goal of the study is to evaluate an investigational drug's effectiveness as a     treatment for Non small-cell lung cancer (NSCLC)   "
153534|NCT01274143|"     The Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project) is     designed to determine whether a personalized telephone plus mailed print cancer risk     assessment and behavior change counseling intervention is more effective than a targeted     mailed print intervention in promoting risk appropriate screening in individuals with a     family history of the disease. The project targets people residing in both rural and urban     areas, allowing an examination of differential intervention effects with regard to place of     residence.   "
153517|NCT01274364|"     Quality diabetes care requires a team approach and informed decisions of patients and care     providers. Several lines of evidence suggests that a protocol-driven care model delivered by     trained staff with focus on periodic assessments, reinforcement of patient compliance and     attainment of multiple treatment targets reduces risk of cardio-renal complications and early     death in type 2 diabetes.      The investigators hypothesize that the use of state of the art information technology to     record, manage and analyze the large amount of clinical information generated during various     consultation visits will improve the effectiveness and efficiency in implementing these care     protocols through decision support and regular feedback to both patients and care team.   "
153518|NCT01274351|"     This study is designed to investigate the molecular and cytogenetic effects and safety     profile of nilotinib in the treatment of early chronic phase of Ph+ CML among different risk     groups of patients and to compare patients with high Socal risk score with patients having     intermediate and low Socal risk score.   "
153520|NCT01274325|"     The purpose of this study is to test hypothesis if Sereflo (ICS/LABA) could reduce airway     inflammation in asthmatic patients in the same as Seretide.   "
153521|NCT01274312|"     Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder     dysfunction. Recently, the concept of a surgically created somato-sensory reflex arch for     bladder dysfunction in SCI has been introduced. The concept is promising, not just for     bladder but also for bowel dysfunction. However, well designed studies need to be performed     before recommending the procedure to a large number of patients worldwide. In this study the     investigators perform multidisciplinary studies providing necessary information about the     clinical outcome of the somato-sensory reflex arch in adult SCI patients.      The hypothesis is as follows:        1. Somato-sensory reflex arch increases colorectal transport between defecations        2. Somato-sensory reflex arch improves colorectal emptying at defecation   "
153522|NCT01274299|"     Anthropometric data of infants' face will be obtained using special 3D scanners and software.   "
153523|NCT01274286|"     Since the first hospital accreditation was implemented in our country in 1978, we have become     the fifth in the world, the first in Asia that applied the system of hospital accreditation.     While discussing the development of the hospital accreditation history of Taiwan, different     concerns have been raised over time.      The main objective of this study is to scrutinize if there have been any quality improvement     of healthcare that hospitals delivered since the renewal of hospital accreditation standards.     Also, in order to provide suggestions to make the hospital accreditation a better one, this     study firstly endeavors to locate the differences which were brought out by both the old and     the new hospital accreditation.      Second, this study will analyze and survey the impacts of accreditation on hospitals'     performance and healthcare. After finishing the first two steps, this study will then state     updated improvement suggestions.      Documentary analysis and meta analysis will be the two major scientific research methods in     this study. Data will be collected from various resources, such as government agencies,     private research institution and hospitals around the nation. By collecting raw data broadly     and deeply, the accountability, therefore, can be ensured.      Throughout the efforts of identifying differences between the new and old accreditation     standards, comparing hospitals' scores on performance index and finding evidence of     performance improvement, we hope this study would provide the most comprehensive and solid     suggestions to improve our hospital accreditation system.   "
153524|NCT01274273|"     The purpose of this study is to determine whether interleukin-2, interferon-alpha in     combination with bevacizumab are effective in the treatment of metastatic renal cell     carcinoma (mRCC).   "
153525|NCT01274260|"     Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating     disorders associated with lung inflammation, low oxygen levels and respiratory failure in     children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these     estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000     deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in     children. In adult patients, use of steroids early in the course of ARDS appears promising.     There are no published clinical trials examining the use of steroids for the treatment of     ALI/ARDS in children.      Hypothesis:      Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours)     and longer than 7 days will have improved clinical outcomes as compared to placebo control     group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly     increased PaO2/FiO2 ratios.   "
153526|NCT01274247|"     Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg     maternal nipple pain and infant's latching difficulties. The procedure carries minor     discomfort for the infants. It is not known whether the use of topical benzocaine, a very     bitter tasting material' applied to the tongue-tie would decrease the length of cry. We will     measure the duration of crying in infants treated with topical benzocaine to the duration in     those not treated with the mediation.   "
153527|NCT01274234|"     All subjects requiring percutaneous coronary intervention (PCI) and stenting are eligible to     participate in the study. Restudy coronary angiogram with Optical Coherence Tomography (OCT)     would be performed between 1 to 5 months at the time of a staged PCI procedure (for remaining     coronary disease) or as clinically indicated, and then at 9 months. At the time of the     9-month restudy (a proper time window for drug eluting stent to develop into restenosis     should it occur), any new disease detected or restenosis will be treated. The reported     incidence of drug eluting stent restenosis is around 10% in simple lesions and is expected to     be higher in diabetic patients, long lesions and multi-vessel diseases; a restudy at 9 months     actually confers better protection to the patients with advanced disease and any restenosis     can be treated timely. All data on clinical events and progress will be monitored and regular     follow-ups will be carried out.   "
153529|NCT01274208|"     Study objectives:        -  Investigate the anti-HCV response in patients with Gaucher disease(GD)        -  Define the potential role of high levels of Glucocerebroside in the immune system      Study hypothesis:      High levels of Glucocerebroside can be used as a tool in the antiviral treatment of hepatitis     C by potentiating the immune response of natural killer T cells and dendritic cells   "
153530|NCT01274195|"     In this study we plan to improve the outcome of hematopoietic stem cell transplantation by     using optimal busulfan dose through pharmacokinetic study.   "
153536|NCT01274117|"     Arteriovenous fistulas (AVFs) are made by joining a vein to an artery in order to get the     vein dilated with sufficient blood flow in order to puncture the vein and clear the blood     from wastes, in patients whose kidneys are destroyed and cannot provide this function. The     success rate of this procedure varies between 50-80% and depends mainly on the size of the     vein, with success being higher with larger veins. One of the veins used for an AVF is the     basilic vein, located at the upper arm. This vein is however deeply located and necessitates     movement (transposition) during surgery to a less deep and lateral path before it is joined     to the artery, in order to be used. A single study has shown that surgery performed in two     parts (one to enlarge the vein and the second one to relocate the enlarged vein under the     wound, not in a new path) is more successful than doing the procedure altogether.      The aim of this study is to confirm the findings of the single study mentioned above (one     versus two stages of basilic vein AVF), with the difference that the vein will be relocated     outside the main wound, a method that is widely accepted as being better.   "
153537|NCT01274104|"     The purpose of this study is to measure the effect vitamin D has in alleviating muscle pain     or aches that may be caused by taking certain medications for treating high cholesterol.   "
153538|NCT01274091|"     Interactions between genes and environment, i.e. our inherited responses to environmental     changes, may be crucial in the development of the common diseases. The investigators were the     first to identify PPARG gene as risk gene for type 2 diabetes. The role of the Pro12Ala     polymorphism in diabetes risk has also been verified in meta-analysis. However, this effect     on seems to depend on intervention and age. In this study the effects of diets high with     saturated fatty acids (SAFA) and polyunsaturated fatty acids (PUFA) are compared in subjects     carrying either Pro12Pro or Ala12Ala genotype of the PPARG gene.      Aim of the study:      To test if subjects with Pro12Pro and Ala12Ala genotypes respond differentially to a diet     supplemented with high saturated (SAFA) or polyunsaturated fat (PUFA).      Hypotheses:        1. Specific: Subjects with the Ala12Ala genotype will be more sensitive to dietary          modification, and therefore respond more favorably to PUFA diet        2. More general: Dietary instructions individually tailored according to the genotype would          allow better treatment of obesity and diabetes   "
153539|NCT01274078|"     About 32 healthy subjects are subjected to 4 weeks of exercise, 4 weeks of washout and 4     weeks of sedentary life style, randomization decides whether they start with exercise or with     being couch potatoes. All participants are also randomized to also consume 150 g of     blueberries on exercise days or not. The exercise is constituted of 5 km running 5 days a     week during the 4 week period. The exercise period and the couch period are started and     ended with a 5 km run at maximal speed and the fasting blood samples for cardiovascular risk     factors are measured before and after this run, ie 8 times in total.   "
153540|NCT01274065|"     There is no common rule as to how a drug will affect patients. This is due to the effect     specific DNA sequences of genes have on drug response, by the effect they have on how     medications are metabolized. The primary objective of this research is to optimize medication     therapy and to reduce the number of medications used, specifically medications for people     with developmental disabilities and co-occuring psychiatric illnesses.   "
153541|NCT01274052|"     The researchers investigated nineteen pregnant women in third trimester and again postpartum.     At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like     peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and     glucagon.      The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit     decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following     delivery when normal glucose tolerance is reestablished.   "
153542|NCT01274039|"     Local therapy for glaucoma is known to induce a conjunctival inflammation. Because of this,     trabeculectomy is more likely to fail. The investigators exchange the local therapy by     systemic therapy using acetazolamide and measure the eye pressure using local therapy and     systemic therapy using acetazolamide. The investigators suspect an elevated eye pressure     using acetazolamide compared to local therapy. In summary acetazolamide could be a better     choice in reference to conjunctival inflammation, but a worse choice in reference to     controlling eye pressure.   "
153580|NCT01273545|"     This study will use electronic health services databases to describe the usage patterns of     dapoxetine hydrochloride (PRILIGY) in Germany and Italy with a focus on describing the extent     and proportion of patients with characteristics suggestive of the use of PRILIGY within,     versus outside of the intended use population.   "
153543|NCT01274026|"     This study seeks to establish evidence:        1. that physiologic changes, unrelated to effect on the PAH enzyme, occur in PKU patients          who are treated with Kuvan® therapy,        2. that these changes may be caused by enhanced neurotransmitter synthesis in the brain or          an upregulation of gene expression (increasing the ability of genes to produce          functional enzymes),        3. and that beneficial changes in behavior and cognition, especially executive functioning          skills may result.      The objective of this study is to correlate any change in behavior and executive function     skills of PKU patients who are non-responsive to sapropterin effect on the PAH enzyme, as     defined by lowered blood PHE levels, with urine neurotransmitter levels and broad gene     expression prior to and after sapropterin administration.      Expected outcomes would include evidence of sapropterin effects on upregulation of enzymes     other than PAH that control neurotransmitter synthesis, and any resulting correlation with     behavioral and cognitive changes.      The investigators hope this study will inform further detailed investigations into the     biochemical and molecular actions of sapropterin (Kuvan®) that lead to increased     understanding of possible treatment effects beyond a lowered blood PHE response.   "
153544|NCT01274013|"     The objective of this study is to assess the prevalence of vitamin D deficiency in patients     with chronic Hepatitis C compared to a matched control group of healthy individuals in the     Sioux Falls area. It is the hypothesis of this study that vitamin D deficiency is more common     in patients with chronic Hepatitis C compared to the healthy control group.   "
153545|NCT01274000|"     A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with     diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.   "
153546|NCT01273987|"     Objective: to evaluate if the Neobladder posterior wall suspended with round ligament of     uterus could improve neobladder empty after radical cystectomy in female patients with     bladder cancer compared to present standard neobladder   "
153549|NCT01273948|"     This will be a randomized, open-label, active-control Phase II pilot trial of bavituximab     combined with ribavirin for initial treatment of chronic HCV genotype 1 infection. Eligible     patients with normal coagulation, hematological, and renal function will undergo a     screening/washout period of up to 28 days, followed by randomization to receive weekly     bavituximab or PEG-IFN alpha-2a therapy for 12 weeks, both with twice-daily ribavirin.      The primary endpoint of this study is the proportion of patients who show a greater than or     equal to 2-log10 IU reduction in plasma HCV RNA level after 12 weeks of treatment (early     virological response; EVR).      Secondary endpoints include the proportion of patients with an undetectable HCV RNA level     after 12 weeks of treatment; the proportion of patients who show a reduction in HCV RNA level     of greater than or equal to 2 log10 IU after 4 weeks of treatment, viral kinetics for     individual patients over time, and comprehensive evaluation of the safety and tolerability of     bavituximab infusion.   "
153550|NCT01273935|"     The aim of this study is to evaluate the low-response prevalence of early antiplatelet     therapy and to test the influence of different aspirin dosages in patients with acute     ischemic strokes (AIS).   "
153551|NCT01273922|"     This randomized, double-blind, placebo-controlled study is a first-in-human Phase 1 study     using two dose levels of an investigational vaccine directed against S. aureus and Candida.     The study is designed to evaluate the safety, tolerability and immunogenicity of the     investigational vaccine, NDV-3   "
153552|NCT01273909|"     The goal of this prospective, observational study is to investigate the clinical,     psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap     reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for     the treatment of lymphedema.      The investigators hypothesize that (1) perforator flap breast reconstruction will result in     excellent clinical, psychosocial, and patient satisfaction outcomes compared to     non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is     associated with less persistent postsurgical pain than other forms of breast reconstruction,     even after controlling for major cofactors, such as the extent of auxiliary lymph node     dissection and the use of radiation therapy; (3) perforator flap reconstruction for the     treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and     complications of lymphedema.   "
153553|NCT01273896|"     The purpose of this study is to find out what effects, good and/or bad, STA-9090 has on the     patient and their breast cancer.      STA-9090 is an experimental drug that works by breaking down cancer proteins. When the cancer     proteins are destroyed, the cancer cells die. STA-9090 is an experimental drug that is not     yet approved for the treatment of cancer by the United States (FDA) Food and Drug     Administration . STA-9090 has been tested in cancer patients in other trials and a safe dose     for this drug has been found. We are now interested to see how active this drug is against     breast cancer.   "
153554|NCT01273883|"     The purpose of this study was to examine any potential benefit in lessening the severity of     tinnitus (ringing or booming sensation in one or both ears) in subjects supplemented with     magnesium (532 mg daily).   "
153555|NCT01273870|"     The aim of the dialyzer evaluation is to compare performance characteristics and     haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux     dialyzers   "
153581|NCT01273532|"     The purpose of this study is to evaluate the bioequivalence of a 100-mg tapentadol (CG5503)     dose administered as two 50-mg ER, TRF tablets relative to one 100-mg ER TRF tablet in     healthy Japanese male participants.   "
153582|NCT01273519|"     The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain     medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and     ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a     contraindication for adalimumab as stated in the released summary of product characteristics.     Therefore it shall be evaluated if pain medication which is used in these participants is     changed, reduced or stopped due to adalimumab treatment.   "
153556|NCT01273857|"     Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are     characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac     output. Infants with the syndrome generally undergo a staged surgical approach in view of an     ultimate Fontan procedure. Although long-term survival in patients with HLHS and related     single ventricle physiology has improved markedly with advances in medical and surgical     therapies, a growing number of infants will ultimately require heart transplantation for     end-stage heart failure due to several potential disadvantages include a negative effect on     right ventricular function, arrhythmia, additional volume load via regurgitation from the     nonvalved shunt, and impaired growth of the pulmonary artery.      Risk factors for poor outcome of heart transplantation with HLHS and single ventricle     physiology are older age at transplantation and previous Fontan operation. New strategies are     needed to improve the underlying transplant risks proper for the Fontan failure patients.      Emerging evidence suggests that heart-derived stem/progenitor cells can be used to improved     cardiac function in patients with ischemic heart disease. In this trial, the investigators     aimed to test the safety and feasibility of intracoronary injection of autologous cardiac     progenitor cells in patients with HLHS and related single ventricle anomalies and that could     improve ventricular function at 3 months' follow up.   "
153557|NCT01273844|"     To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone)     followed by autologous hematopoietic stem cell transplantation as an initial treatment in     patients with newly diagnosed AL.   "
153558|NCT01273831|"     The purpose of this study is to determine which drug makes lower intraocular pressure   "
153559|NCT01273818|"     Aim of this study is to measure the effectiveness of topical gentamicin to prevent     post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is,     if it is effective as a prophylactic agent, to compare it's effect with intra venous single     dose cefazolin sodium prophylaxis.   "
153560|NCT01273805|"     Hydroxychloroquine is approved for the treatment of non-cancerous illnesses such as     rheumatoid arthritis and systemic lupus erythematous. Researchers in the laboratory have     tested tumors from patients with pancreatic cancer and have discovered that they have certain     pathways inside the cells that promote growth and survival of the tumor. Hydroxychloroquine     may inactivate these pathways and results in the death of pancreatic cancer cells.   "
153564|NCT01273753|"     The purpose of this study is to examine the impact of exercise during dialysis using     objective measures of fluid status determination, specifically bioimpedance analysis (BIA)     and blood volume monitoring (BVM). We hypothesize that exercise during dialysis will be     associated with more stable blood pressures and that this will be reflected in different     output from BIA and BVM monitoring.   "
153565|NCT01273740|"     Randomized study to evaluate the effect of adding external support to PTFE-grafts used for     bypass to below knee arteries in patients with critical limb ischemia with respect to primary     patency, secondary patency, and limb salvage.   "
153566|NCT01273727|"     An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion of     vision and lead to swelling, or macular edema. Despite surgery to remove the scar     tissue(membrane peeling), residual swelling of the retina may continue to interfere with     vision.      In this study the investigators will inject an implantable steroid device into the back,     fluid-filled portion of the eye. Steroids have been found to decrease the swelling in the     retina. Ozurdex™ is an implantable steroid. Once implanted, Ozurdex™ is slowly dissolved by     the vitreous gel that fills the eye, releasing the steroid. The steroid drug delivery system     in this study, known as Ozurdex™ has been FDA-approved by the US Food and Drug Administration     (FDA) for decreasing swelling due to another condition in the eye. This study will help to     find out whether or not this device Ozurdex™ is also effective for reducing the swelling of     the retina in patients who have already had surgery to remove scar tissue on the retina.   "
153567|NCT01273714|"     The extent of thyroid resection in benign goiter is controversial. Potential advantages of TT     over BST may include: one-stage removal of incidental thyroid cancer reported in up to 10% of     operatively treated benign thyroid diseases, and lower risk for goiter recurrence. However,     these potential advantages should outweigh the risk of morbidity associated with more radical     thyroid resection.      The aim of this study was to compare outcomes of bilateral subtotal (BST) vs. total     thyroidectomy (TT) for benign bilateral thyroid disease.   "
153568|NCT01273701|"     The hospital where this study will be conducted is responsible for the one-year contingency     management treatment for methamphetamine drug offenders referred from the Yunlin District     Prosecutors Office. Completing the one-year treatment is prerequisite for offenders to get     slow prosecutions.      It is an open-label, parallel-group trial comparing the combination of psychosocial     intervention and slow prosecutions with psychosocial intervention alone in treating subjects     with methamphetamine dependence      Study Hypothesis        1. Psychosocial interventions in combination with slow prosecutions is more effective than          psychosocial interventions alone to achieve abstinence for subjects with methamphetamine          abuse/dependance.        2. Inclusion of telephone reminding before each visit will enhance the retention rate and          abstinence rate.   "
153569|NCT01273688|"     Lateral epicondylitis is a painful overuse condition also described as lateral elbow     tendinopathy. As at the Achilles tendon or the patella tendon, lateral elbow tendinopathy has     striking clinically and histologically similarities. As such, neovascularisation closely     related to pain-mediating fibers are encountered. Eccentric painful exercise is of clinical     use in Achilles and patella tendinopathy. We sought to evaluate the clinical effect of a     painful eccentric training (supination and pronation) with or without a orthopedic elbow     brace in lateral epicondylitis.   "
153570|NCT01273675|"     It is well understood that hypertension, dyslipidemia, and diabetes mellitus are the major     risks of chronic kidney disease. Current guidelines recommend screening kidney estimated     glomerular filtration function with serum creatinine. But it is not the utmost effective     method and the GFR would be underestimated. Since good correlation was noticed between serum     creatinine and chronic kidney disease, urinary microalbumin levels is better for patients     with risks of chronic kidney diseases. With adequate and early education, or antihypertensive     agents with angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor     blockers (ARB), all could alleviate renal function deterioration and the severity of     proteinuria. As a result, high sensitive methods is urgent and needed for early screening and     diseases following up under medication with ACEi and ARB in chronic kidney disease patients.     In this project, the investigators are going to include the patients with typy II diabetes     mellitus combining with hypertension who are treated with antihypertensive agents. Such     volunteers will be treated with Candesartan 8-16mg/ day and maintain systolic blood pressure     <130 mm/Hg, diastolic blood pressure < 80 mm/ Hg as the goal. Therefore, this project would     make effort on correlation with urinary microalbumin and other biomarkers changes under     Candesartan treatment- one of ARB medication for 12 weeks, and further exploration of new     biomarkers that may be related to renal parenchymal injuries.   "
153571|NCT01273662|"     This is a phase II study of axitinib as the second-line on the treatment of advanced     hepatocellular carcinoma (HCC).      The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor     effect in HCC. The primary endpoint is disease stabilization that lasts for at least 8 weeks     without progression of tumor-related symptoms.   "
153572|NCT01273649|"     Anterior cruciate ligament(ACL) injury is one of the most common sport injuries. The major     problem after ACL reconstruction or rehabilitation program is quadriceps weakness. Previous     studies suggested that cryotherapy and transcutaneous electrical nerve stimulation(TENS) can     effectively reduce the arthrogenic muscle inhibition caused by experimental swelling.      Objective:      To exam the effects of 12 weeks cryotherapy and TENS on arthrogenic muscle inhibition in     subjects with ACL reconstruction.      Design:      Prospective study.      Subjects:      Male subjects with isolated ACL injury, age between 18~40 years old are going to receive an     ACL reconstruction surgery.      Methods:      Quadriceps activation level, quadriceps peak torque during maximal voluntary contraction and     rate of force development are measure at presurgery, 3-month, 6-month after surgery. After     surgery, subjects will receive 12 weeks, 3 days/week, training programs included 20 minutes     cryotherapy and exercise training with TENS.      Data analysis:      Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL). One-way ANOVA will     be used to analysis data.   "
153573|NCT01273636|"     Objective: To examine the risk factors for coexisting endometrial carcinoma in patients with     endometrial hyperplasia.      Method: Seventy-seven patients who received hysterectomy for endometrial hyperplasia were     enrolled and divided into the non-endometrial carcinoma group (57) and the endometrial     carcinoma group (20) depending on the final pathology. Clinical variables were analyzed.   "
153574|NCT01273623|"     To investigate the treatment effects with the Jetstream G3 System in moderate to severely     calcified peripheral artery disease in the common femoral, superficial femoral or popliteal     arteries using intravascular ultrasound (IVUS).   "
153575|NCT01273610|"     This phase II trial studies the side effects and how well lapatinib ditosylate and     trastuzumab work in treating older patients with human epidermal growth factor receptor 2     (HER2)-positive breast cancer that has spread from where it started to nearby tissue or lymph     nodes (locally advanced) or to other parts of the body (metastatic). Lapatinib ditosylate may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some     block the ability of tumor to grow and spread. Others find tumor cells and help kill them or     tumor cancer-killing substances to them. Giving lapatinib ditosylate together with     trastuzumab may kill more tumor cells.   "
153576|NCT01273597|"     This observational study will evaluate the clinical benefit of Zemplar (paricalcitol     injection) in daily routine practice in end-stage renal disease patients with severe     over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will     be collected from participants initiated on Zemplar therapy according to standard of care.     The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the     proportion of participants achieving target parathyroid hormone levels, and prevalence of     elevated serum calcium and phosphate levels will be evaluated.   "
153577|NCT01273584|"     Obesity is on the rise in all developed countries. Of particular concern is that more young     people including children are being recognised as being overweight or obese. We know from a     recent large national enquiry into all maternal and child deaths in the UK, known as CEMACH,     that obesity is a major risk both for the mother and her child. When all deaths in women     during pregnancy are analysed, obesity comes out as the most common risk factor. Babies of     obese mothers are more than 3 times as likely to need admission to the Neonatal Intensive     Care Unit.      Traditionally, obesity is treated by lifestyle measures encouraging healthy eating and     increasing physical activity. Unfortunately these measures are often insufficient to produce     significant improvements in weight. If obese women gain little or even no weight during     pregnancy, the outcome of the pregnancy is known to be improved. This was shown in a very     large study of more than 120, 000 obese women.      The drug metformin has been used for years in the treatment of diabetes and more recently for     polycystic ovary syndrome (PCOS). Studies in pregnant PCOS women and women with diabetes in     pregnancy have shown it to be safe and effective. Fortunately it is relatively cheap and     taken as a tablet with meals.      Metformin has the great advantage of not causing weight gain and often leads to a small     amount of weight loss. It works by improving the body's sensitivity to insulin which is     important as resistance to insulin is common in obesity.      We have a lot of experience using metformin to treat women with diabetes in pregnancy where     it is greatly beneficial. We now wish to examine its potential for obese women who do not     have diabetes. We are hoping to show that it will benefit these women by causing less weight     gain, less high blood pressure, and less diabetes. We anticipate babies will also have better     birth weights, will be easier to deliver naturally, will not need to go to special care baby     units and will be healthier.   "
153578|NCT01273571|"     The purpose of the study is to investigate the potential interaction between multiple oral     doses of canagliflozin and a single oral dose of metformin in healthy adult volunteers.   "
153579|NCT01273558|"     The purpose of this study is to compare the results from two methods used to determine the     renal threshold for glucose excretion (defined as the lowest plasma glucose concentration at     which appreciable amounts of glucose appear in the urine) in untreated patients with type 2     diabetes mellitus and in patients with type 2 diabetes mellitus who are treated with 100 mg     once-daily canigliflozin for 8 days.   "
153587|NCT01273454|"     This study aims to collect clinical information and to examine the usefulness and safety of     ORal Osmotic System Hydromorphone in Korean cancer patients. The decision to treat patients     with drug is as per physician discretion and that doses are determined based upon approved     labeling recommendations and physician discretion.   "
153588|NCT01273441|"     Helicobacter pylori is the main cause of chronic gastritis, peptic ulcer and gastric tumors     (adenocarcinoma and lymphoma). The cure of the H. pylori infection prevents recurrence of     duodenal and gastric ulcer and improves dyspepsia in a significant proportion of cases, so it     is cost-effective.      Eradication therapy has changed over time. The usually recommended pattern in the consensus     conferences has traditionally been triple therapy, composed by the combination of 2     antibiotics (clarithromycin plus amoxicillin or metronidazole) and a proton pump inhibitor     (PPI) for 7-14 days. Recent meta-analyses have that the current global eradication rate after     standard triple therapy is less than 80%. Several European studies have found even lower     eradication rates, with 35-40% of cases resulting in treatment failure. Treatment failure     leads to a second treatment and a new diagnostic test to confirm eradication.   "
153589|NCT01273428|"     Testing a drug and a device for the treatment of pressure ulcers, compared with current     treatments.   "
153590|NCT01273415|"     Gene expression studies have identified at least four molecularly distinct subtypes of breast     cancer including two biologically distinct ER-positive subtypes of breast cancer: luminal A     and luminal B (with luminal B tumors having poorer outcomes than luminal A tumors). Although     some luminal B tumors can be identified by their expression of HER2, the major biological     distinction between luminal A and B is the proliferation signatures, including genes such as     CCNB1, MKI67, and MYBL2, which have higher expression in luminal B tumors than in luminal A     tumors. The high cost of gene expression profiling has limited its incorporation into general     clinical practice. To date, there is no available IHC-based surrogate assay that can     distinguish between luminal A and luminal B tumors. We hypothesized that the IHC     determination of the Ki67 index as well as ER, PgR, and HER2 status is able to distinguish     the luminal B subtype of breast cancers from the luminal A subgroup.   "
153591|NCT01273402|"     This study is being done to select an appropriate TF2 bsMAb dose suitable for pretargeting     the 111In/90Y-labeled hapten-peptide (IMP-288). Eligible patients will receive a fixed dose     of 90Y-IMP-288 4 days after the TF2 antibody injection. Two different dose levels of TF2 will     be studied in the first part.      Once an appropriate TF2 dose is selected based on information learned from the first 2 dose     levels, patients will be enrolled onto several different increasing dose levels of     90Y-IMP-288.   "
153592|NCT01273389|"     The purpose of this study is to evaluate the efficacy and safety of CNTO 136 administered     intravenously in patients with active, International Society of Nephrology/Renal Pathology     Society Class III and IV Lupus Nephritis (LN).   "
153593|NCT01273376|"     The purpose of this study is to determine whether RX-10100 are effective in the treatment of     Major Depressive Disorder (MDD).   "
157700|NCT01219491|"     To identify the characteristics in an egg donor that are important to a recipient and to see     if those characteristics change over time.   "
153595|NCT01273350|"     Prospective, non-randomized, single-center cohort study treating internal carotid artery     stenosis using the Xact Carotid Artery Stent and emboshield distal protection system in     conjunction with bivalirudin as the procedural anticoagulation   "
153596|NCT01273337|"     The purpose of this study is to demonstrate the safety of the delivery of ALD-401 by     intracarotid infusion and to assess efficacy of treatment in subjects who have had     unilateral, predominately cortical, ischemic strokes in the middle cerebral artery (MCA).     ALD-401 is made from the stroke patient's bone marrow and infused 13-19 days after the     stroke.   "
153597|NCT01273324|"     The dual mobility design concept for acetabular liners, as is used in the Restoration ADM     Acetabular System, has been applied in various implants since its introduction by Gilles     Bousquet in France in 1976. Dual mobility cups have shown good clinical results and have been     particularly lauded for low incidence of dislocations. However, the wear performance of this     design concept has not been proven to date. As wear particles are a possible contributing     factor in aseptic loosening, the assessment of wear and fixation is an important step in     proving this implant design.      The proposed study will combine RSA and peri-prosthetic bone mineral density as well as     outcome questionnaires to provide a complete in vivo evaluation of prosthesis fixation,     polyethylene wear, and objective and subjective outcomes for the Restoration ADM Acetabular     System.   "
153598|NCT01273311|"     Background:      - The Coronary Artery Risk Development in Young Adults (CARDIA) study is an investigation of     cardiovascular risk factors among African-American and white young adults between 18 and 30     years of age, first recruited in 1985 86 from Birmingham, AL; Chicago, IL; Minneapolis, MN;     and Oakland, CA. The study has examined a wide variety of risk factors, including insulin     resistance, obesity, and diabetes. Based on 20 years of followup, the data provide evidence     of an increase in the prevalence of many cardiovascular risk factors, as well as other     factors that may lead to brain disease. To further evaluate these changes, the CARDIA Year 25     Exam will include a brain imaging component to study brain structure and function in a subset     of CARDIA participants.      Objectives:      - To conduct brain magnetic resonance imaging as part of a 25-year followup study on     participants in the original CARDIA study of heart disease risk factors in young adults.      Eligibility:      - Existing CARDIA study participants in the Minneapolis, MN, and Oakland, CA regions.      Design:        -  Participants will be screened with a full medical history and physical examination. -          Participants will have an MRI scan at the 25-year followup examination for the CARDIA          study.        -  No additional testing or treatment will be required for this protocol.   "
153643|NCT01272726|"     The goal of this research study is to measure what percentage of women who suspect they have     symptoms of ADHD will go on to be diagnosed with ADHD using accepted practice standards. The     study will also evaluate the influence education on the genetics of ADHD has on a woman in     her deciding to receive behavioral health treatment for ADHD.   "
153879|NCT01269658|"     The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic     solution, 1% versus vehicle over a four-week treatment period in treating the signs and     symptoms of subjects with blepharitis and to evaluate the clinical course of the condition     under study.   "
153599|NCT01273298|"     Patients with chronic obstructive pulmonary disease (COPD) are at greater risk of suffering     from diseases for which beta-blockers may be indicated and effective. Clinicians remain     hesitant to administer beta-blockers to COPD patients for fear of adverse effects on lung     function. However, cardioselective beta-blockers therapy led to a non-significant worsening     of resting expiratory flow limitation measured by the forced expiratory volume in one second     (FEV1) as compared to placebo. But, the FEV1 appears to be a crude estimate bronchial     obstruction in COPD. Importantly, the effects of cardioselective beta-blockers on dynamic     hyperinflation, a subtle marker of bronchial obstruction, remain unknown. Thus, a prospective     placebo-controlled study assessing the effects of short-term cardioselective beta-blocker     therapy on dynamic hyperinflation in patients with moderate-to-severe COPD is needed.   "
153600|NCT01273285|"     To assess the reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer     thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and     to compare these results to conventional Time-Domain-OCT (TD-OCT).        -  Trial with medical device   "
153601|NCT01273272|"     The purpose of this study is to determine whether a comprehensive cognitive-behavioral     therapy-based, multi-component treatment programme is effective in the treatment of     neuropsychiatric symptoms of patients with mild Alzheimer's dementia.   "
153602|NCT01273259|"     DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic     hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in     human. The purpose of this study is to determine if DHEA is effective in the treatment of     respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease     (COPD) on exercise capacity and haemodynamic variables. Patients will receive after     randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation     concerns clinical parameters, echocardiography and right catheterization after and before     treatment. Primary end-point is the six-minute walk test. This is a prospective double blind,     randomised, placebo controlled study which will be realized in four university hospitals in     France : Bordeaux, Strasbourg, Toulouse and Limoges.   "
153603|NCT01273246|"     A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine     in healthy children (3-11y) and infants (6-35m).   "
153604|NCT01273233|"     A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type     71 Vaccines in healthy adults   "
153613|NCT01273116|"     The current organization of hospital care for older patients with complex healthcare needs is     of insufficient quality, safety and efficiency. Frail older patients have a higher risk for     development of complications and consequently a higher length of hospital stay, a higher risk     of functional decline, and higher care needs after discharge. As nearly half of the patients     admitted to Dutch hospitals is over 65 years, it is highly necessary to adapt the     organization of hospital care to their needs. Besides having introduced the medical specialty     geriatrics, hospital management has not started to provide hospital wide healthcare tailored     to frail older patients. Therefore, the purpose of this study is to develop and examine the     effectiveness of an intervention program for frail older patients admitted to hospital aimed     at preventing functional decline and other hospital related negative outcomes.   "
153605|NCT01273220|"     Background:      - Alcohol use disorders are the most prevalent mental disorders in the United States and are     a factor in more than 10 percent of all deaths, including heart disease, stroke, and certain     types of cancer and chronic illness. Research into better treatment methods for alcohol use     disorders and their associated disabilities requires a broad amount of information on the     genetic and environmental factors that predispose certain individuals to alcoholism. To     improve the quality of available information for research, the National Institutes of Health     is conducting a nationwide survey on alcohol use disorders and related physical and mental     disabilities, and will collect genetic information through saliva samples.      Objectives:      - To collect interview data and saliva samples from the U.S. civilian noninstitutionalized     population, 18 years and older, in order to study the extent of and contributing factors to     alcohol use and abuse in the United States.      Eligibility:      - Individuals at least 18 years of age who do not live in institutions (i.e., prisons,     inpatient mental hospitals) and who are willing to be interviewed in English, Spanish, and     the four most commonly spoken Asian languages in the United States (e.g., Chinese, Korean).      Design:        -  The study will involve three main components: an automated computer-assisted interview,          an automated questionnaire, and the collection of a saliva sample.        -  Participants will be recruited through community through publically available U.S.          Census Bureau files.        -  The interview and questionnaire will ask standardized questions related to personal          history; alcohol use and possible disorders; symptoms scales of mood, anxiety, and          eating conditions that frequently co-occur with alcohol and drug use disorders; tobacco,          medicine and drug use and disorders; selected personality traits, including behavior;          alcohol, drug, and mental health treatment utilization; and medical conditions related          to alcohol consumption.        -  Participants will provide a saliva sample for genetic study.      Background:      - Alcohol use disorders are the most prevalent mental disorders in the United States and are     a factor in more than 10 percent of all deaths, including heart disease, stroke, and certain     types of cancer and chronic illness. Research into better treatment methods for alcohol use     disorders and their associated disabilities requires a broad amount of information on the     genetic and environmental factors that predispose certain individuals to alcoholism. To     improve the quality of available information for research, the National Institutes of Health     is conducting a nationwide survey on alcohol use disorders and related physical and mental     disabilities, and will collect genetic information through saliva samples.      Objectives:      - To collect interview data and saliva samples from the U.S. civilian noninstitutionalized     population, 18 years and older, in order to study the extent of and contributing factors to     alcohol use and abuse in the United States.      Eligibility:      - Individuals at least 18 years of age who do not live in institutions (i.e., prisons,     inpatient mental hospitals) and who are willing to be interviewed in English, Spanish, and     the four most commonly spoken Asian languages in the United States (e.g., Chinese, Korean).      Design:        -  The study will involve three main components: an automated computer-assisted interview,          an automated questionnaire, and the collection of a saliva sample.        -  Participants will be recruited through community through publically available U.S.          Census Bureau files.        -  The interview and questionnaire will ask standardized questions related to personal          history; alcohol use and possible disorders; symptoms scales of mood, anxiety, and          eating conditions that frequently co-occur with alcohol and drug use disorders; tobacco,          medicine and drug use and disorders; selected personality traits, including behavior;          alcohol, drug, and mental health treatment utilization; and medical conditions related          to alcohol consumption.        -  Participants will provide a saliva sample for genetic study.   "
153606|NCT01273207|"     Bronchiolitis Obliterans (BO) is an obstructive lung disease that can affect individuals that     have undergone a lung or hematopoietic stem cell transplant. BO has been studied most     extensively in lung transplant recipients, where it is considered to represent chronic lung     rejection. It is the leading cause of death after lung transplant, with mortality rates up to     55 percent. In hematopoietic stem cell transplantation, BO is thought to be a manifestation     of chronic graft-vs-host disease (GVHD). Up to 45 percent of patients undergoing     hematopoietic stem cell transplantation at the NHLBI develop a decline in pulmonary function.     Conventional therapy for patients who develop BO consists of augmentation of systemic     immunosuppressants. Systemic immunosuppression has limited efficacy for BO and is associated     with deleterious consequences including increased risk of infections and decreased     graft-versus tumor/leukemia effects.      Recently, cyclosporine inhalation solution (CIS) in solution with propylene glycol has been     shown to improve overall survival and chronic rejection-free survival in lung transplant     patients. These findings suggest targeted delivery of immunosuppressive therapy to the     diseased organ warrants further investigation as this may minimize the morbidity associated     with systemic immunosuppression. However, there currently exists limited data regarding the     overall efficacy of inhaled cyclosporine to treat established BO following lung     transplantation. Furthermore, inhaled cyclosporine has not been studied in the treatment of     BO following hematopoietic stem cell transplantation.      Here, we propose to evaluate the long-term safety and efficacy, of inhaled CIS for the     treatment of BO. Enrollment will be offered to subjects who have completed the end of study     (week 18 visit) for the initial protocol (Phase II Trial of CIS in lung transplant and     hematopoietic stem cell transplant recipients for treatment of Bronchiolitis Obliterans) and     who have shown evidence of benefit (either an improvement or stabilization) in BO/BOS with     CIS treatment.      Clinical parameters, including pulmonary function tests, will be measured in addition to     laboratory markers of the anti-inflammatory response to CIS. Adverse events associated with     extended treatment with CIS will be recorded.      The primary objective is to provide long-term safety and efficacy data for the use of CIS in     hematopoietic transplant patients and lung transplant patients with established BO.      Secondary objectives include investigation of the inflammatory pathways that lead to chronic     BO and ascertainment of the long term anti-inflammatory effects of this CSA preparation ex     vivo and in vivo.      Primary endpoint is the efficacy of extended use CIS for BO/BOS. Secondary endpoints include     the toxicity profile (adverse events), improvement in high resolution chest CT images,     results of peripheral blood and bronchoalveolar cytokine arrays to assess secondary markers     of inflammation, and functional capacity measurements using a six-minute walk test.   "
153618|NCT01273051|"     In the Netherlands approximately 2300 new patients are diagnosed with rectal cancer each     year. Standard treatment for patients with a T2 or T3 rectal cancer consists of preoperative     short course of radiotherapy followed by surgery. In advanced cases long course of     radiotherapy combined with chemotherapy is used instead of a short cause. In some of these     advanced cases a complete remission is observed after a long course of radio-/chemotherapy.     Patients who respond well to neo-adjuvant treatment carry a better prognosis.      Objective of this research is to evaluate whether neo-adjuvant chemo-/radiotherapy in small     non-advanced rectal cancers can be used to obtain a complete or near complete remission. In     these patients could a complete resection of the rectum as an organ be avoided by treating     them with a local excision with the TEM-technique (Transanal Endoscopic Microsurgery) of the     scar. The advantage for these patients is, that they do not need major abdominal surgery and     in a substantial number of these patients the rectum can be preserved with a better function     of continence.   "
153619|NCT01273038|"     The aim of the current clinical investigation is to evaluate a new filter.   "
153620|NCT01273025|"     The study aims to investigate the pharmacokinetic parameters and its antioxidative effects in     Thai healthy men.   "
153607|NCT01273194|"     Background:      - Palliative care, also known as comfort care, is intended to keep a patient comfortable by     focusing on pain and symptom management to improve quality of life. Although palliative care     has been demonstrated to be beneficial, it is underutilized in children who have been     diagnosed with cancer, because current trends favor palliative care primarily at the end of     life and in only a small number of patients. Children with cancer likely would benefit from     the incorporation of palliative care from the time of diagnosis, but both doctors and     families are often reluctant to include it for a variety of reasons. Researchers are     interested in understanding these reasons to determine better ways to include palliative care     as part of cancer treatment methods in children with cancer.      Objectives:      - To collect information on pediatric oncology patients and their parents attitudes towards     palliative care, along with cancer treatment, from the time of diagnosis.      Eligibility:        -  Children and adolescents between 10 and 17 years of age who have been diagnosed with          cancer in the past year.        -  Parents of eligible children.      Design:        -  Participants will complete a 30-minute survey about experiences with pain, symptom          management, and focus on quality of life in the first month following cancer diagnosis.          Child participants will be asked about their views on the importance of quality of life          in the beginning of their illness, as well as their attitudes toward symptom-oriented          care. Parent participants will be asked questions about their child s illness, which          includes understanding, discussion, and impact of illness.        -  Treatment will not be provided as part of this protocol.   "
153614|NCT01273103|"     This study is a Phase I, open-label, single dose, mass balance study in a cohort of 6 healthy     adult male subjects. The study will consist of: Screening evaluations, a treatment phase, and     follow-up evaluations. In the treatment phase, after an overnight fast of at least 10 hours,     each subject will receive a single oral suspension dose of GSK2248761 200mg containing [14C]     - GSK2248761. Following dosing, serial whole blood, plasma, urine, and fecal samples will be     collected. Subjects will be required to remain in the unit until the radiocarbon excreted     falls to less than or equal to 1% of the administered dose for two consecutive 24-hour     collections in both urine and feces, whichever occurs first. Safety will be assessed by vital     signs, 12-lead electrocardiogram (ECG), clinical laboratory tests, AE monitoring, and     physical examinations as indicated.   "
158655|NCT01207011|"     The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the     treatment of non-small cell lung cancer (NSCLC).   "
153608|NCT01273181|"     Background:      - MAGE-A3/12 is a type of protein commonly found on certain types of cancer cells,     particularly in metastatic cancer. Researchers have developed a process to take lymphocytes     (white blood cells) from cancer patients, modify them in the laboratory to target cancer     cells that contain MAGE-A3/12, and return them to the patient to help attack and kill the     cancer cells. These modified white blood cells are an experimental treatment, but researchers     are interested in determining their safety and effectiveness as a possible treatment for     cancers that involve MAGE-A3/12.      Objectives:      - To evaluate the safety and effectiveness of anti-MAGE-A3/12 lymphocytes as a treatment for     metastatic cancers that have not responded to standard treatment.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma,     renal cell cancer, or another type of metastatic cancer that has not responded to standard     treatment.      Design:        -  Participants will be screened with a full medical history and physical examination, as          well as blood and urine tests, tumor samples, and imaging studies.        -  Participants will have leukapheresis to collect enough white blood cells for          modification in the laboratory.        -  Seven days before the start of anti-MAGE-A3/12 treatment, participants will have          chemotherapy with cyclophosphamide and fludarabine to suppress the immune system in          preparation for the treatment.        -  After the last dose of chemotherapy, participants will receive the anti-MAGE-A3/12 cells          as an infusion for 20 to 30 minutes, followed by a dose of interleukin-2 to keep the          anti-MAGE-A3/12 cells alive and active as long as possible. Participants will also          receive filgrastim to encourage the production of blood cells.        -  Participants will remain in the hospital to be monitored for possible side effects, and          after release from the hospital will have regular followup exams with blood samples and          imaging studies to evaluate the effectiveness of the treatment....   "
153609|NCT01273168|"     Background:        -  Some types of cancer cells that have hormone receptors on their surfaces need the          hormone estrogen to grow. The drug tamoxifen blocks estrogen from binding to the tumor          cells, which helps to slow or stop the growth of cancer. Tamoxifen has been approved for          treatment of certain types of estrogen-linked cancers, such as breast and ovarian          cancer.        -  The experimental drug Z-Endoxifen HCl (endoxifen) is related to tamoxifen, and has been          shown to work against similar estrogen-linked cancers. In many cancer patients,          tamoxifen is turned into endoxifen by enzymes in the liver; however, not all people have          the liver enzymes that can turn tamoxifen into endoxifen, which means that the drug          cannot work properly. Taking certain other drugs at the same time as tamoxifen can also          keep it from turning into endoxifen. Researchers are interested in determining whether          endoxifen tablets are effective in slowing or stopping tumor growth in individuals whose          hormone-linked tumors have not responded to standard treatment.      Objectives:      - To test the safety and effectiveness of daily endoxifen in individuals with hormone     receptor positive solid tumors that have not responded to standard treatment.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with hormone receptor positive     solid tumors (breast or other tumors), desmoid tumors, or gynecologic tumors that have not     responded to standard treatment.      Individuals with breast cancer must have had at least one prior chemotherapy regimen and one     prior hormonal regimen for metastatic disease.      Design:        -  Participants will be screened with a full medical history (including prior hormone use)          and physical examination, as well as blood and urine tests, tumor imaging studies, and          an eye examination.        -  Participants will take endoxifen tablets daily for 28-day cycles of treatment, and will          be asked to keep a medication diary to record any side effects.        -  Participants will have regular clinic visits with blood and urine samples and imaging          studies to evaluate the cancer's response to treatment.        -  Participants will continue to take endoxifen for as long as the cancer responds to the          treatment.   "
153610|NCT01273155|"     Background:      - Belinostat is an experimental cancer treatment drug that works by helping to turn on genes     that limit cell growth and survival of the tumor that are switched off in cancer cells.     Belinostat has been given to patients with different types of cancer to measure its safety     and effectiveness, but it has not been given in a formal trial to cancer patients who have     abnormal liver function. Because belinostat is processed by the liver, its safety and     effectiveness needs to be established in individuals who have abnormal liver function.     Researchers are interested in comparing the effects of belinostat as a cancer treatment drug     in individuals with normal and abnormal liver function.      Objectives:        -  To test the safety and effectiveness of belinostat in individuals who have solid tumors          and lymphomas and who also have abnormal liver function.        -  To compare the results of belinostat treatment in individuals with normal and abnormal          liver function.      Eligibility:        -  Individuals at least 18 years of age who have been diagnosed with solid tumors or          lymphomas that have not responded to standard treatment.        -  Individuals with normal liver function and varying degrees of abnormal liver function          (mild, moderate, severe) are eligible.      Design:        -  Participants will be screened with a full medical history and physical examination, as          well as blood and urine tests, and tumor imaging studies. Participants will then be          divided into study groups based on their liver function.        -  Participants will receive belinostat in cycles of treatment. Except for cycle 1, all          cycles will last 21 days. Cycle 1 will last 28 days. For cycle 1 only, participants will          receive a single dose of belinostat 1 week before the regular 21-day treatment cycle          starts.        -  In each cycle, participants will receive belinostat once a day for 5 days, and will be          asked to keep a medication diary to record any side effects.        -  Participants will have regular clinic visits with blood and urine samples and imaging          studies to evaluate the cancer s response to treatment.        -  Participants may continue to take belinostat for as long as the cancer responds to the          treatment....   "
153611|NCT01273142|"     The purpose of this study is to demonstrate the difference in frequency and level of liver     function disturbance between patients on efavirenz based ART, and patients on nevirapine     based ART in HBV and HCV co-infected patients, (and/or with patients with abnormal liver     function prior to ART), in China. Liver function tests will be measured at baseline and     follow-up.   "
153621|NCT01273012|"     The purpose of this study is to determine whether the probiotic Infloran is cost-effective in     treating acute childhood diarrhea.   "
153622|NCT01272999|"     Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective     against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar.     It is expected that the effectiveness of Prevnar 13 against ear infections in children will     be similar to that observed following Prevnar. Pfizer has committed to conduct a     postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.   "
153623|NCT01272986|"     This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic     myocardial ischemic and acute coronary syndrome patients.   "
153624|NCT01272973|"     This trial is conducted in Europe. The aim of the trial is to investigate safety,     tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and     pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male     subjects   "
154915|NCT01256138|"     Allogene MSCs transplantation will be performed in patients with chronic liver diseases     through portal vein by ultrasound guiding and therapeutic effects including short-term     effects and long-term follow-up will be compared and investigated.   "
153612|NCT01273129|"     Background:      - Medically intractable epilepsy is the term used to describe epilepsy that cannot be     controlled by medication. Many people whose seizures do not respond to medication will     respond to surgical treatment, relieving seizures completely or almost completely in one-half     to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of     this treatment are not experimental, but researchers are interested in training more     neurologists and neurosurgeons in epilepsy surgery and care in order to better understand     epilepsy and its treatment.      Objectives:      - To use surgery as a treatment for medically intractable epilepsy in children and adults.      Eligibility:      - Children and adults at least 8 years of age who have simple or complex partial seizures     (seizures that come from one area of the brain) that have not responded to medication, and     who are willing to have brain surgery to treat their medically intractable epilepsy.      Design:        -  Participants will be screened with a medical history, physical examination, and          neurological examination. Imaging studies, including magnetic resonance imaging and          computer-assisted tomography (CT), may also be conducted as part of the screening.          Participants who do not need surgery or whose epilepsy cannot be treated surgically will          follow up with a primary care physician or neurologist and will not need to return to          the National Institutes of Health for this study.        -  Prior to the surgery, participants will have the following procedures to provide          information on the correct surgical approach.        -  Video electroencephalography monitoring to measure brain activity during normal          activities within a 24-hour period. Three to four 15-minute breaks are allowed within          this period.        -  Wada test to evaluate speech, comprehension, and memory centers of the brain, using a          contrast dye to study the blood vessels of the brain and a short-term anesthetic          administration procedure to test the effects on areas of speech and memory.        -  Depth electrodes and/or brain surface electrodes to measure brain activities and          determine the part of the brain that is responsible for the seizures (seizure focus).        -  Participants will have a surgical procedure at the site of their seizure focus. Brain          lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality          will be either removed or treated in a way that will stop or help prevent the spread of          seizures without affecting irreplaceable brain functions, such as the ability to speak,          understand, move, feel, or see.        -  Participants will return for outpatient visits and brain imaging studies 2 months, 1          year, and 2 years after surgery.   "
158669|NCT01205815|"     The purpose of this research is to identify biological characteristics occurring in the     initiation and progression of melanoma.   "
153615|NCT01273090|"     RATIONALE: Imetelstat sodium may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase I clinical trial is studying the side effects and best dose of imetelstat     sodium in treating young patients with refractory or recurrent solid tumors or lymphoma.   "
153616|NCT01273077|"     Two rotavirus vaccines have been authorized for use in Canada: RotaTeq®, Merck Frost Canada,     Inc. and Rotarix®, Glaxo Smith Kline (GSK). In contrast to the United States, Australia and     several other western countries, neither rotavirus vaccine is offered in a publicly funded     program in Canada. A universal rotavirus immunization program offered to all children has the     potential to prevent moderate to severe forms of the disease associated with rotavirus, with     associated decreased disease burden and health care costs. This demonstration project seeks     to evaluate the effect of the implementation of a universal infant immunization program with     Rotarix employing two different program delivery models (public health delivery or physician     office delivery) in comparison to a jurisdiction where routine immunization is not provided.     Only evaluation of the program will be the subject of this study.   "
153617|NCT01273064|"     Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC)     treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1     chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies).      Null-responders are defined as patients who failed to achieve a greater than 2 log drop in     HCV-RNA (Hepatitis C Ribonucleic acid, also known as viral load) levels after 12 weeks of     treatment (know as an early virologic response, or EVR) during previous SOC therapy.      If, during previous SOC treatment, a patient had a less than 2 log decline in HCV-RNA at Week     12 but greater than 2 log decline in HCV-RNA at any time from Week 12 to Week 24, that     patient is not a null-responder, and is excluded from study participation. If, during     previous SOC treatment, a Week 12 HCV-RNA was not obtained, the post Week 12 response must     have been < 2 log decline (and still HCV-RNA positive) in order for the patient to be defined     as a null-responder.      Patients will be screened and have up to 4 weeks to qualify for study entry. During this     screening period, clinical and laboratory tests will be performed. At Week 0/Day 1, patients     will undergo centralized, stratified (based on ethnicity), randomization to one of four     treatment arms: SOC + one of three doses of CTS-1027 or SOC + placebo. Study treatment will     last 24, 48, or 60 weeks, based on each patient's response to study treatment. SOC + placebo     patients who do not show a virologic response after 12 weeks of therapy will be rolled onto     SOC + 15mg CTS-1027, while maintaining the study blind.   "
153640|NCT01272765|"     This is a pilot study to determine the safety and efficacy of an investigational product     (IHBG-10) on weight change and changes in body composition in subjects who have been taking a     stable dose of certain anti-psychotic medications for longer than three months.   "
153641|NCT01272752|"     This is a pilot study to determine the safety and efficacy of an investigational product     (IHBG-10) on weight change and changes in body composition in subjects who have just started     taking (for less than three months) certain anti-psychotic medications (Risperdal, Seroquel,     and/or Zyprexa).   "
153642|NCT01272739|"     This is a pilot study to determine the safety and efficacy of an investigational product     (IHBG-10) on weight loss, and changes in body composition.   "
165070|NCT00005757|"     To determine whether differences in the activity of the renin-angiotensin and bradykinin     systems are involved in the pathogenesis of blood pressure variation in African Americans.   "
153625|NCT01272960|"     In order to determine the timing of LNG-IUS insertion that results in a greater proportion of     women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial     of interval versus immediate post-placenta insertion. Women will be enrolled at 36-weeks     gestation and greater. At the time of vaginal delivery, women will be randomized to receive     either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8 weeks     post-partum. All patients will return at 4-6 weeks post-insertion and 6 months post-partum to     confirm correct position of the LNG-IUS. The primary outcome of this sub-study is the number     of LNG-IUS in the correct position at 6-months. Secondary outcomes include assessing the     safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms     experienced by participants. This is a sub-study of the Contraceptive Choice Project, a     prospective cohort study that aims to improve the use of long-acting contraception by     removing financial barriers which has already enrolled over 5,000 patients. Association of     this study with CHOICE offers unique advantages including infrastructure to support subject     recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS     devices.      We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS     immediately after placenta delivery will have higher rates of LNG-IUS continuation due to     poor rates of follow up in the interval insertion group. This is likely to be particularly     noticeable in our patient population, which is largely uninsured with poor access to     healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping,     which may be disguised by the post-partum period. Published reports of immediate     post-placenta insertion focus on expulsion rates and do not report on symptoms and     satisfaction rates.   "
153626|NCT01272947|"     The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied     four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs   "
153627|NCT01272934|"     The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied     four times a day in subjects with acute ankle sprains under 'in-use' conditions, in     particular with regard to pain relief.   "
153628|NCT01272921|"     The duration of motor block for infragluteal parabiceps sciatic nerve block following total     knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic     given.   "
153629|NCT01272908|"     This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients     with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or     current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera     1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24     weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on     study treatment is 48 weeks.   "
153630|NCT01272895|"     All patients who have received GENOUS stent implantation at Queen Mary Hospital for treatment     of ischemic heart disease are eligible for this study. Those with clinical indications to     undergo restudy coronary angiogram or staged procedure PCI will be primarily recruited into     this study.      Optical coherence tomography (OCT) will be performed early after stent implantation to     evaluate vascular healing response and neointimal coverage.   "
153683|NCT01272206|"     This trial is conducted in Europe. The aim of this trial is to investigate the safety and     pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011     compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.   "
153631|NCT01272882|"     Electrical impedance tomography (EIT) monitoring has been researched as a method to determine     the spatial impedance distribution in a body cross section, but has yet to become an     established clinical tool. EIT monitoring gives a dynamic, breath-to-breath measurement of     both global and regional ventilation. Recently, there has been evidence that EIT monitoring     has great potential to become a non-invasive bedside tool for assessment of regional lung     ventilation without documented hazards. Potential applications include any adult patients in     acute respiratory failure. Data collected from this research may contribute to improved     patient safety outcomes.      PURPOSE:      The purpose of this pilot study is to examine the feasibility of using the EIT monitor in     intensive care unit (ICU) setting on patients with acute respiratory failure and to compare     the EIT monitor data to standard of care patient assessments. It is hypothesized that the EIT     monitor, when applied to adults in acute respiratory failure, will correlate with     conventional standard of care assessments for these patients.   "
153632|NCT01272869|"     The aim of the current clinical investigation is to evaluate a new filter   "
153633|NCT01272856|"     The purpose of this study is to test the safety of the study drug abatacept and see what     effects (good and bad) it has in patients with relapsing polychondritis.   "
153634|NCT01272843|"     The carotid arteries are blood vessels in the neck that supply blood to the brain. Carotid     stenosis disease is defined as a narrowing of these arteries due to the build up of plaque.     The plaque material can also break off and move into the brain. The resulting blockage of     blood supply to a portion of the brain is what causes 80% of all strokes. One treatment     option is to have surgery on the carotid artery and remove the plaque. This procedure is     called a carotid endarterectomy (CEA). There is evidence that proves CEA reduces the risk of     stroke. The objective of this research project is to determine who is most likely to benefit     from CEA surgery.   "
153635|NCT01272830|"     This research study is being conducted to determine if taking oral (by mouth in pill form)     Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and     improve function of non-infected symptomatic postoperative total joint replacements.   "
153636|NCT01272817|"     Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses     including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative     syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.   "
153637|NCT01272804|"     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK),     and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses     in patients with type 2 diabetes.   "
153638|NCT01272791|"     The primary objective of this study is to compare the overall survival of patients with stage     IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.   "
153639|NCT01272778|"     This placebo-controlled crossover study is intended to measure the effect of four doses of     lorazepam on brain activity measured by magnetoencephalography (MEG) and     electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple     cognition testing on 16 healthy male volunteers. On each of five study days subjects will be     randomized to receive either 0.2, 0.5, 1.0 or 2.0 mg lorazepam or placebo. Brain activity     will be measured by MEG and EEG in each subject a total of 4 times each study day: prior to     medication administration and 2, 4, and 6 hours after medication administration. Blood     samples to determine medication levels and cognition testing will be performed at     pre-medication baseline and immediately after each post-medication scan time. Data will be     analyzed to identify changes in brain activity compared to baseline and placebo     administration using both standard approaches and the Orasi Synchronous Neural Interaction®     (SNI) test. This study will test the hypothesis that dose-response changes in brain     functional activity can be accurately measured by MEG/EEG in healthy volunteer subjects after     single, acute doses of lorazepam.   "
153644|NCT01272713|"     - Aim      The AVOID (Air Verses Oxygen In myocardial infarction) trial is designed to determine if the     withholding of routine oxygen therapy in patients with acute heart attack leads to reduced     heart damage compared to the current practice of routine inhaled oxygen for all patients.      - Background      There is evidence supporting and refuting the current practice of providing oxygen to all     patients with acute heart attack. A recent summary of clinical trials suggested that oxygen     may increase the degree of heart damage during heart attack. It also highlighted that the few     trials into oxygen therapy were performed before the use of modern medications and procedures     to treat heart attack and that further studies were urgently needed, using contemporary     practices.      - Design      A total of 334 patients will participate in this randomized controlled trial. Patients in     this study will receive the best current management and care for their condition. Patients     will be randomized to routine pre-hospital care with oxygen therapy vs pre-hospital care     without oxygen therapy. Patients will then receive standard hospital care, aside from     allocated oxygen or no oxygen therapy. The primary outcome measure of heart damage will be     investigated using routine blood tests. With additional information gathered from other     aspects of routine heart care including coronary angiogram, electrocardiograms and     complications of hospital stay. Patients will be followed up at 6 months to determine any     longer term effects of treatment.   "
153645|NCT01272700|"     Prone position in spinal surgery can increase airway pressure and decrease dynamic lung     compliance by a frame used for postural stabilization. Also, it can increase hemodynamic     instability such as reduced blood pressure by aggravating cardiac index.      Former study shows pressure controlled ventilation on the pulmonary mechanics can improve     alveolar use and oxygenation than volume controlled ventilation. The latter one means     controlling a patient's breathing completely through tidal volume and set breathing rate.     This could be useful for the patients not possible to breath by themselves because it     guarantees the perfect breathing.      The pressure controlled ventilation is used when there is a possibility to change a patient's     environment. The pressure will be maintained steadily, but volume and flux will be changed.     That means through the pressure already set, the whole breathing will be maintained from the     beginning to end. If a patient's resistance is increased, the volume will be decreased even     though the way of blood pressure control is same. However, the tidal volume per minute can be     controlled somewhat and barotrauma can be decreased by controlling respiratory rate. Through     this study, we are expecting the pressure controlled ventilation in prone position can     improve lung mechanics and oxygenation.   "
153646|NCT01272687|"     The genotype-phenotype correlation in patients with Parkinson's disease with specific     mutations in the glucocerebrosidase gene (Gaucher gene) is known from own clinical     experiences as well as from case reports in the literature. The epidemiological study will     determine the frequency of heterozygous mutations in the glucocerebrosidase gene and     correlate to the clinical onset and development by measuring and documenting severity of     symptoms (e.g. cognitive deficits, L-dopa responsiveness, depression) in clinically     well-characterized Parkinson's patients.   "
153647|NCT01272674|"     Adiponectin and exercise training contribute to the maintenance of a normal vascular tone by     influencing vascular NO bioavailability and concentration and function of endothelial     progenitor cells. The molecular mechanisms are only partially understood. Therefore, aim of     the present study is to elucidate the effects of Adiponectin on endothelial progenitor cell     migration and the underlying signaling pathways. Furthermore, the impact of exercise training     on adiponectin-mediated endothelial progenitor cell migration will be investigated.   "
153648|NCT01272661|"     Breast for Success is a new direct service program focused on overcoming barriers to     breastfeeding for low-income inner-city mothers by use of a culturally competent and     home-based educational and support intervention. Key project components include a new     Enhanced Breastfeeding Curriculum with brief engaging health literacy focused modules, and     two innovative support plans, the Breastfeeding Doula and Father Support Programs. The     objective is to increase breastfeeding rates for high-risk inner-city mothers.      Research Questions to evaluate project feasibility and effectiveness are:        1. Were all aspects of the Curriculum and Doula and Father Support Programs implemented?        2. Is there an increase in the rate of any breastfeeding at 1 month postpartum for all          mothers?        3. Is there a difference in the rate of any breastfeeding at 1 month postpartum between          interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?        4. What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?   "
153649|NCT01272648|"     This project will test and evaluate a rehabilitation programme, which will empower the mens     health and give them resources to face at new everyday life.      The project examines if a focused interdisciplinary intervention has influence of the     patients generic and specified quality of life after curative radiotherapy due to prostate     cancer.      The intervention contains nursing consultation with information about late side effects, an     individual plan and counselling in toilet habits, smoking cessation, weight control and     psychological problems after treatment. Furthermore the patients are having physiotherapy     with pelvic floor examinations. The nurse can refer to other collaborators.   "
153650|NCT01272635|"     This protocol is comprised of two separate, but linked, clinical trials for treating     preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL)     will try to prevent wheezing illness from developing using azithromycin. If a wheezing     illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms     using oral corticosteroids.   "
153663|NCT01272466|"     Anti-apoptotic proteins from the Bcl-2 family are known to play a key role in oncogenesis and     are overexpressed in myeloma cells. Studies have shown that dendritic cells exposed to     proteasome inhibition present exogene antigens better than unexposed dendritic cells.     Patients with relapse of multiple myeloma will be offered vaccination with peptides derived     from antiapoptotic proteins from the Bcl-2 family in combination with an immunostimulatory     adjuvant. The vaccination will be given in relation to treatment with the proteasome     inhibitor bortezomib.   "
153664|NCT01272453|"     This is a prospective, controlled observational trial of patients undergoing clinically     indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography     and coronary CT angiography (CCTA).   "
156548|NCT01234662|"     To compare three Types of anesthetic techniques (Spinal anesthesia, Combined spinal epidural     anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain     after elective cesarean section.   "
153651|NCT01272622|"     The present investigation is a prospective, multicenter study evaluating craniopharyngioma     patients' prognoses following the various currently-practiced therapeutic strategies.Primary     goals of the study are to establish quality standards and compare the various therapy     strategies with respect to their effectiveness and impact on the quality of life of treated     patients. A stratified randomization of two treatment arms will be conducted with respect to     timing of postoperative irradiation for the subgroup of patients ≥5 years of age whose tumors     are incompletely resected. The researchers will investigate whether an immediate,     postoperative irradiation is superior to progression-contingent irradiation based on     alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month     post op) to 3 years after randomization. Progression-free survival and overall survival will     be examined as closely-related subgoals.Postoperative data will be evaluated via a     surveillance study for all complete resection patients as well as for those patients under 5     years of age regardless of their resection grade.   "
153652|NCT01272609|"     Pulsed dye laser (PDL)is the gold standard treatment of port wine stains (PWS). However, many     sessions are required and failure or relapses are not uncommon. It has been demonstrated that     a neoangiogenesis occurs after PDL, explaining at least partially those failure. The     objective of this study is to evaluate the use of a topical beta-blocker (timolol 1% gel) as     a combination treatment with PDL for treating PWS.      Methods. Prospective multicenter study comparing PDL alone to PDL + timolol. Sessions of PDL     will be performed once a month for 3 months. One group will be treated with PDL alone and the     other will also applied timolol 1% gel twice a day during treatment. The evaluation will be     done one month after the third session.   "
153653|NCT01272596|"     Impairment of visual deficits, in particular contrast acuity and contrast impairment are     frequent symptoms in MS. However, visual function is not appropriately covered by the     standard tools for clinical assessment, namely, the EDSS and the MSFC.      The primary aim of this study is to investigate, whether in MS patients contrast acuity and     sensitivity change over a period of two years.      Secondary aims are the correlation of visual contrast parameters with structural retinal     changes and quality of life.   "
153684|NCT01272193|"     This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and     safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with     type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects     continued at the same dose and dosing frequency.   "
153654|NCT01272583|"     Hypoglycaemia is a well-known complication of insulin treated diabetes. The counterregulatory     response to hypoglycaemia, with glucagon as the most important mediator, is initially     diminished within a few years of onset of Type 1 diabetes and subsequently lost and thus     increasing the risk of hypoglycaemia. Dipeptidyl Peptidase (DPP)-4 inhibitors augment the     glucagon response to insulin-induced hypoglycaemia in type 2 diabetes. The investigators     hypothesize that treatment with a DPP-4 inhibitor in patients with type 1 diabetes will     recover the alpha cell response to hypoglycaemia.   "
153655|NCT01272570|"     The 3 Specific Aims are (1) To determine the prevalence, incidence and severity of oral     conditions in postmenopausal early stage breast cancer survivors within the first 18 months     of adjuvant Aromatase Inhibitor(AI) therapy, (2) To determine the oral health quality of life     among postmenopausal early stage breast cancer survivors who are receiving AI therapy, (3) To     determine the utilization of dental care among postmenopausal women receiving AIs with a     history of early stage BCa over time. The hypothesis for this pilot study is that AIs     negatively impact oral health and oral health quality of life in the setting of breast cancer     survivors. Further, we hypothesize that dental visits are underutilized in women with BCa     undergoing adjuvant AI therapy.   "
153656|NCT01272557|"     This study is a prospective, randomized, open-label, multicenter phase IIB trial in order to     determine time to progression of the combination therapy sorafenib plus doxorubicin against     standard-of-care sorafenib in advanced HCC not amenable to non-systemic treatment.   "
153657|NCT01272544|"     The aim of this longitudinal study was to assess the oral health of individuals attending a     mother-child dental care program (PPPWB). The mean DMFT and GBI in the second phase and the     control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the     individuals who attended the PPPWB had better oral health status than the control group. When     the two phases of the study were compared, it was noted that the individuals in the second     phase had better oral health, although they had a higher score for gingival bleeding.   "
153658|NCT01272531|"     This is a prospective pharmacogenomics study of mood stabilizer response. The goal of this     work is to identify genes associated with good response of patients with bipolar disorder to     two commonly used mood stabilizing agents, lithium and valproate.   "
153659|NCT01272518|"     The purpose of this study is to characterize the behavior of cardiac patients with Mood     Disorders and its clinical course, interpreting the results from a theoretical framework of     Chaos Theory and Complexity Theory and Systems as well.   "
153660|NCT01272505|"     Single incision laparoscopic cholecystectomy is gaining widespread acceptance. there are some     obstacles making this procedure more complex than conventional laparoscopic cholecystectomy.     The use of harmonic scalpel may aid in solving some of these issues that may allow     simplification of the technique. The investigators will compare the ordinary method of single     incision laparoscopic cholecystectomy versus harmonic scalpel single incision laparoscopic     cholecystectomy.   "
153661|NCT01272492|"     The investigators are recruiting participants for a randomized controlled trial to evaluate     the usability and educational value of a nutrition education touchscreen computer program     targeting Spanish-speaking Latina caregivers of children 2 and under.      Participants will be randomized to the intervention group - use the computer program and the     control group - do not use the program. They will be asked basic demographic questions,     nutrition knowledge questions and computer users will be asked usability questions.      Objectives are        1. Evaluate the subjective and objective usability of the touchscreen computer.        2. Determine whether health knowledge on nutrition topics is enhanced through the use of          the computer modules.   "
153662|NCT01272479|"     The aim of this study is to address questions regarding the link among hepcidin,     hematological iron markers, inflammation and hepatitis C in HD patients. In attempt to     address this issue, we planned to measure serum levels of hepcidin prohormone (pro-hepcidin),     inflammatory and iron parameters.   "
153715|NCT01271790|"     This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug     regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without     Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).   "
153665|NCT01272440|"     Asparaginase is an important drug i the treatment of childhood leukaemia.      The aim of this project is to study the pharmacokinetics, pharmacodynamics and antibody     development and hypersensitivity reactions during prolonged PEG-asparaginase treatment.      Study part 1) Asparaginase pharmacokinetics and pharmacodynamics during prolonged     PEG-asparaginase treatment: A NOPHO ALL-2008 study      Study part 2) Asparagine depletion in cerebrospinal fluid: A NOPHO ALL-2008 study      Study part 3) A characterization of PEG-asparaginase hypersensitivity in children treated     according to the NOPHO ALL 2008 protocol      Perspectives: New knowledge about PEG-asparaginase treatment regarding dosing, dosing     interval, adverse effects and EFS, which may lead to improved future therapy      Patients: Children diagnosed with acute lymphoblastic leukaemia in the Nordic Countries   "
153666|NCT01272427|"     The investigators hypothesize that glucose and whey protein given 30 and 60 min before a     pizza meal will exert different effects on food intake in adolescent children, and will     depend on pubertal stage. Food intake will be measured at 30 and 60 min following a     glucose(0.75 g of glucose/kg body weight), whey protein (0.75 g of glucose/kg body weight) or     sweetened noncaloric beverage. Subjective appetite will be measured as well.   "
153667|NCT01272414|"     Currently there are few therapeutic options for the treatment of lid retraction secondary to     thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable     of creating a ptosis, that in the setting of TO can return the upper lid to a more     physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent     stage lid position. This investigation aims to examine the properties of this relationship.   "
153668|NCT01272401|"     The purpose of this study is to determine how physical activity, other lifestyle factors, and     psychosocial factors are related to quality of life and other health outcomes across the     breast cancer survival spectrum from diagnosis to long term survival in a nationally     representative sample of breast cancer patients and survivors across a 6 month period of     time.   "
153685|NCT01272180|"     This study will evaluate the safety and immunogenicity of combination vaccines as compared to     the reference vaccines   "
191641|NCT00353470|"     This study will determine the relative effectiveness of three psychotherapies in treating     people with a panic disorder.   "
153669|NCT01272388|"     Currently, aortic stenosis (AS) is considered a surgical disease with no medical therapy     available to improve any clinical outcomes, including symptoms, time to surgery, or long-term     survival. Thus far, randomized studies involving statins have not been promising with respect     to slowing progressive valve stenosis. Beyond the valve, two common consequences of aortic     stenosis are hypertrophic remodeling of the left ventricle (LV) and pulmonary venous     hypertension; each of these has been associated with worse heart failure symptoms, increased     operative mortality, and worse long-term outcomes. Whether altering LV structural     abnormalities, improving LV function, and/or reducing pulmonary artery pressures with medical     therapy would improve clinical outcomes in patients with AS has not been tested. Animal     models of pressure overload have demonstrated that PDE5 inhibition influences NO-cGMP     signaling in the LV and favorably impacts LV structure and function, but this has not been     tested in humans with AS. Studies in humans with left-sided heart failure and pulmonary     venous hypertension have shown that PDE5 inhibition improves functional capacity and quality     of life, but patients with AS were not included in those studies. The investigators     hypothesize that PDE5 inhibition with tadalafil will upregulate NO-cGMP signaling, reduce     oxidative stress, and have a favorable impact on LV structure and function as well as     pulmonary artery pressures and quality of life. In this pilot study, the investigators     anticipate that short-term administration of tadalafil to patients with AS will be safe and     well-tolerated.   "
153670|NCT01272375|"     The purpose of this study is to investigate the time course of PF-04764793 concentration in     the blood following dosing by oral inhalation from dry powder inhalers.   "
153671|NCT01272362|"     In this 5-months study, the response of patients to salbutamol at baseline will be compared     with their response to treatment with indacaterol.   "
153672|NCT01272349|"     The goal of the study is to determine whether repeatedly breathing low oxygen levels for     brief periods (termed intermittent hypoxia) will improve limb function after spinal cord     injury. This idea stems from animal studies on respiration, in which investigators have shown     that mild intermittent hypoxia improves breathing in spinally injured rats. These studies     have shown that intermittent hypoxia induces spinal plasticity, strengthening neural     connections and motor neuron function within the spinal cord. Exposure to mild intermittent     hypoxia triggers a cascade of events, including increased production of key proteins and     increased sensitivity of spinal cord circuitry necessary for improved breathing.      The ultimate goal of this research is to assess the potential of mild intermittent hypoxia as     a therapeutic approach to stimulate recovery of limb function in human patients.   "
153673|NCT01272336|"     The goal of the study is to examine the effects of repeated breathing episodes of mild     intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability     following cervical spinal injury, and to determine whether these changes result in improved     hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability of     the nervous system to strengthen neural pathways based on new experiences), which could     result in improvements in hand use for persons with spinal cord injury (SCI).   "
153674|NCT01272323|"     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with     allergic rhinoconjunctivitis and/or asthma.      The purpose of this optional observational follow-on study is to further evaluate     rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who     completed all dosing visits in study CP005 approximately one year after the start of     treatment.   "
153675|NCT01272310|"     The study is aimed to investigate the safety, tolerability and efficacy of a fixed dose     combination therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (PEG-IFN     alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected adult subjects who     failed to respond following a course of PEG-IFN and RBV Therapy.   "
153676|NCT01272297|"     Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED     patients responding to PDE5i's. This study aimed to determine the capability of swt to     convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.   "
153677|NCT01272284|"     An international, multi-center, single arm, prospective clinical study designed to assess the     safety and efficacy of the Coloplast Altis single incision sling system for females with     stress urinary incontinence (SUI).   "
153678|NCT01272271|"     This retrospective chart review study compares the incidence of corneal inflammation due to     infection in children vs. adult patients wearing overnight corneal reshaping lenses.   "
153679|NCT01272258|"     PRO 140 2102 is a phase 2b, national, multicenter, randomized, double-blind,     placebo-controlled study in order to evaluate the safety and efficacy of PRO 140 (anti-CCR5     monoclonal antibody) administered subcutaneously as an adjunct to a new, optimized, oral     antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented     poor adherence to the previous antiretroviral regimen.   "
153680|NCT01272245|"     The goal of this clinical research study is to learn if omacetaxine given with cytarabine can     help to control the disease in patients with AML or high-risk MDS. The safety of the study     drugs will also be studied.   "
153681|NCT01272232|"     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).      The aim of this trial is to investigate the potential of liraglutide to induce and maintain     weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added     onto subject's pre-trial background diabetes treatment of either diet and exercise only or     single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or     glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration     of the trial will be 56 weeks followed by a 12 week observational follow-up period.   "
153682|NCT01272219|"     This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.      The aim of this clinical trial is to evaluate the potential of liraglutide to induce and     maintain weight loss over 56 weeks in obese subjects or overweight subjects with     co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide     to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.      Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either     68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment     period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects     with pre-diabetes status at baseline).   "
153686|NCT01272167|"     Epidemiological studies definitively show that fruit and vegetable consumption is an     important factor for the prevention of age-related diseases such as cardiovascular diseases     (CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently     consumed worldwide, essentially as juices.      Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely     flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively     significant source of a specific flavanone called naringin.   "
153687|NCT01272154|"     Purpose      - Objective : Sensorimotor adaptation allows the modification of the motor command taking     into account the errors detected during execution of prior movements. It involves a large     cortico-subcortical network. Isolated lesions of this network do not systematically alter     sensorimotor adaptation except for cerebellar lesions. The cerebellum is thus a key structure     for sensorimotor adaptation. However, the link between cerebellar and the cortical plasticity     underlying sensorimotor adaptation remain unknown. Alteration of sensorimotor adaptation is     associated with dystonia but it is unclear whether it is a cause or consequence of dystonia.     It has been hypothesized that the abnormal plasticity observed in dystonia could account for     the associated alteration of sensorimotor adaptation.      Classically, basal ganglia dysfunction is considered to be crucial for dystonia pathogenesis.     However, recent studies suggest that the involvement of the cerebellum may also be important     in this setting. In primary dystonia, imaging studies showed abnormal cerebellar activation     during sensorimotor adaptation tasks and neurophysiological studies demonstrated a decrease     of cerebellar output.      The aim of this study is to investigate the role of the cerebellum in the cortical plasticity     underlying sensorimotor adaptation both in healthy subjects (normal plasticity) and in     dystonic patients (abnormal plasticity).      - Methods: Paired associative stimulation PAS consists in repetitive pairing of a peripheral     nerve and a cortical stimulation. This kind of stimulation has been designed to induce     artificial plasticity that can be easily measured. This PAS induced sensorimotor plasticity     is exacerbated and has lost its topographical specificity in dystonic patients.TMS using     trains of TMS pulses (rTMS) can be applied on the cerebellum to modulate its output. We will     test the effect of rTMS induced modulation (cTBS- inhibitory, iTBS-excitatory, sham) of the     cerebellar output on PAS induced plasticity in patients with dystonia and healthy control.      We will also assess the acute effect of the rTMS induced modulation of the cerebellar output     on the dystonic symptoms and on the performance at a validated sensorimotor adaptation task.     This will be done by double blind post-hoc scoring of the dystonia (BFM or TWSTRS) on     standardized videorecording and measurement of the performance at the task after each rTMS     session (cTBS, iTBS, sham).      Finally, we will assess the variation of PAS effect on other parameters reflecting cortical     excitability after each rTMS session (cTBS, iTBS, sham).   "
153688|NCT01272141|"     The patient is being asked to join this clinical research study to find out if lapatinib, an     agent that targets a protein, called epidermal growth factor receptor (EGFR) on the surface     of cancer cells in combination with everolimus, an agent that targets a protein in the cancer     cell, called mammalian target of rapamycin (mTOR) is effective in metastatic triple negative     breast cancers that are no longer controlled by standard chemotherapy.   "
153689|NCT01272128|"     The primary objective is to assess the quality of life of intramuscular (IM) Interferon     Beta-1a in participants with relapsing remitting multiple sclerosis (RRMS) or Clinically     Isolated Syndrome (CIS) in a clinical practice setting.   "
153690|NCT01272115|"     Background: Climacteric stage women experience significant biological, psychological and     social changes. With demographic changes being observed in the growing number of climacteric     stage women in Mexico, it is important to improve their knowledge about the climacteric stage     and its potential associated problems, encourage their participation in screening programs,     and promote the acquisition of healthy lifestyles.      At Mexican health care institutions the predominant health care model for climacteric stage     women has a biomedical perspective. Medical doctors provide mostly curative services and have     limited support from other health professionals. This study aims to design an integrative     health care model (IHCM: bio-psycho-social, multidisciplinary and women-centered) applicable     in primary care services aimed at climacteric stage women.      Methods: A field trial with one intervention and one comparison group, with ex ante and ex     post measurements will be conducted in two IMSS primary care clinics in Mexico City. The     clinics will be selected for convenience; each clinic must have more than 20 family doctors'     offices and available space for the intervention (consulting room and an area for group     counseling) and should have accepted to participate in the study; The intervention will be     conducted in one clinic and the other clinic will serve as a comparison group, where the     usual care for climacteric stage women will be observed.      The study population will consist of women affiliated with IMSS, between 45 and 59 years of     age with a maximum of 5 years after menopause. The women should be users of the clinic, and     should not have mental conditions that would prevent them from understanding the information     or from taking independent decisions (dementia, mental retardation or psychosis), a physical     disability that would impede them from participating (hearing loss, diseases affecting     physical mobility as severe forms of rheumatoid arthritis), medical diagnosis of depression,     diabetes mellitus, hypertension, renal or liver failure, and/or cancer, because patients with     these diseases require specific care provided by several specialists. All women must agree to     participate in the study through written informed consent.      The IHCM consists of collaborative and coordinated provision of services by a health team,     which is involves a family doctor, nurse, psychologist, and the woman herself. The health     team promotes the empowerment of women through individual and group counseling on the     climacteric stage and health related self-care. The intervention lasts three months followed     by a three-month follow-up period to evaluate the effectiveness of the model. The     effectiveness of the model will be evaluated through the following aspects: health-related     quality of life (HR-QoL), empowerment, self-efficacy and knowledge regarding the climacteric     stage and health-related self-care activities, use of screening services, and improvement in     lifestyles (regular leisure time, physical activity and healthy diet).      The sample size for the primary outcome (HR-QoL) was estimated by using the formula to test     change in the mean of two normally distributed samples in longitudinal studies. An average     increase of at least 10 points in one or more domains of WHQ23 in the intervention group     compared with control group women was considered to be clinically relevant. The assumptions     included: a mean HR-QoL score of 64.9 points (standard deviation of 23.4 points) in the     domain of general well-being, a= 0.05 ( for one-sided hypothesis) and ß = 0.20. The number of     women by group, assuming a drop-out rate of 20% will be 107.      We also estimated a sample size for regular leisure time physical activity considering that     this is the outcome variable more difficult to achieve. It was assumed that only 17% of women     in Mexico engaged in some type of regular leisure time physical activity and a positive     increase of at least 10% will be achieved after women participation in the IHCM. For this     calculation, we used the formula to test the difference of proportions between two     populations with a= 0.05 (one side) and the power of 80%. The total number of women by group     to include assuming a drop-out rate of 20% will be 207.      Discussion: Participation in preventive activities should be encouraged among women in     Mexico. Designing and evaluating the effectiveness of an integrative health care model for     women at the climacteric stage, based on the empowerment approach and focus on health-related     self-care to improve their HR-QoL is pertinent for current health conditions of this age     group.   "
153691|NCT01272102|"     To determine the area under the Receiver Operator Characteristic Curve (AUC) for the Ganglion     Cell Analysis (GCA) average thickness.   "
153692|NCT01272089|"     The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed     once-daily, in subjects with allergic conjunctivitis and to record any adverse events as     described by the subjects as a part of this post marketing surveillance study.   "
153693|NCT01272076|"     The objective of this study is to compare Cirrus HD-OCT automated measurements of the     illumination area under the retinal pigment epithelium (RPE) to expert manual measurements of     areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF)     images.   "
153694|NCT01272063|"     The objective of this study is to compare the areas designated as elevated retinal pigment     epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus     photographs (CFPs).   "
153716|NCT01271777|"     The purpose of this study is to demonstrate the efficacy on insulin sensitivity of GFT505 at     80mg/d in male patients with insulin resistance and abdominal obesity. Evaluation will be     made using a glucose clamp technique.   "
153695|NCT01272050|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known     which radiation therapy regimen is more effective in treating patients with relapsed prostate     cancer.      PURPOSE: This randomized phase III trial is studying the side effects of radiation therapy     and comparing two radiation therapy regimens in treating patients with relapsed prostate     cancer after surgery.   "
153697|NCT01272024|"     1.) To integrate discharge planning into an intervention provided by advanced practice nurses     (APRNs)for patients with advanced cancer, 2.) To evaluate the effects of the intervention,     and 3.) To explore the reach, adoption, and implementation of the intervention to facilitate     the transition of patients from surgery/biopsy/chemotherapy to medical oncology in a     comprehensive cancer center.   "
153698|NCT01272011|"     Change to Reflect What Was Done and reason Changes Were Made.      The purpose of this study is to determine (1) if a specific breathing treatment (intermittent     hypoxia) can promote changes in breathing function and (2) if pairing breathing treatments     (hypoxia) with locomotor training can enhance the benefits of walking recovery observed with     locomotor training alone (without breathing treatments).   "
153700|NCT01271985|"     The purpose of this study is to determine the effects of PolyPill tablet (a fixed dose     combination of two anti-hypertensive medications, atorvastatin and aspirin) on primary and     secondary prevention of cardiovascular disease in Iranian adults older than 50.   "
153701|NCT01271972|"     This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/     SAR307746) administered IV every 2 weeks.   "
153702|NCT01271959|"     The purpose of this research study is to collect information from patient's medical records     that had a test called ChemoFx® ordered and to understand how doctors may have used the     results of the ChemoFx® to treat patients with cancer.   "
153703|NCT01271946|"     The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne     Access System in patients undergoing diagnostic angiographic procedures through the femoral     artery.   "
153704|NCT01271933|"     The purpose of this study is to evaluate the efficacy and safety of a controlled release     formulation of pregabalin administered once daily as compared to placebo in the treatment of     fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo     at some point in the study.   "
153740|NCT01271465|"     The purpose of this study is to see if substances measured in a small piece of the donor     organ predicts how well the organ will function in the recipient after transplant. We will be     testing blood, urine, and biopsy tissue samples in this study. The research team will be     looking at different risk factors in the donor organ that predict how well the kidney will do     in the recipient.   "
153705|NCT01271920|"     The phase Ib part of the trial will assess the MTD of AUY922 in combination with Trastuzumab     in patients with Trastuzumab-refractory locally advanced or metastatic HER2+. The MTD is     defined as the highest drug dosage not causing in the first cycle of treatment (28 days)     medically unacceptable dose limiting toxicity (DLT).      The phase II part of the trial will assess any potential effect on efficacy of adding AUY922     to Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+     breast cancer.      Both AUY922 and Trastuzumab will be administered as a weekly IV infusion. Treatment should be     continued as long as the patient does not have disease progression and tolerates the     treatment. The following reasons are examples of acceptable reasons for discontinuing the     study; tumor progression (by RECIST, as assessed by the investigator), unacceptable toxicity,     death, or discontinuation from the study for any other reason, such as patient refusal,     withdrawn consent, lost to follow-up or investigator decision.   "
153706|NCT01271907|"     Background:        -  Recent cancer treatment studies have shown that altering a cancer patient's own white          blood cells may help the immune system fight the cancer. In all of these studies,          participants donate their own white blood cells through a procedure called          leukapheresis, and the cells are altered in the laboratory and given back to the          participants. After the cells are given, the patients receive aldesleukin (IL-2) to help          the tumor fighting cells stay alive longer. For individuals with metastatic melanoma,          pieces of melanoma proteins may be added to the collected white blood cells to help the          immune system recognize and attack the cancer cells.        -  Researchers are interested in testing a new process in which cells from fruit flies          (Drosophila) are used to help the melanoma proteins attach to the white blood cells. The          fruit fly cells die off shortly after the proteins are introduced to the white blood          cells. Researchers are also interested in determining whether IL-2 treatment is          necessary after this new cancer treatment process.      Objectives:        -  To test the safety and effectiveness of modified white blood cells (Drosophila-generated          CTL) as a treatment for metastatic melanoma that has not responded to standard          treatments.        -  To determine whether IL-2 treatment improves the effectiveness of Drosophila-generated          cytolytic T lymphocytes (CTL).      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma that     has not responded to previous IL-2 treatment.      Design:        -  Participants will be screened with a physical examination and medical history, tumor          imaging studies, and heart and lung function tests.        -  Prior to treatment, participants will have an intravenous catheter inserted into the          chest to administer the study drugs.        -  Participants will have leukapheresis to provide white blood cells for laboratory          modification.        -  Seven days before the start of the treatment, participants will be admitted to the          hospital to have chemotherapy with cyclophosphamide and fludarabine. These drugs will          suppress the immune system to improve the effects of the treatment.        -  One to four days after the last dose of chemotherapy, participants will receive the          modified cells. Participants in the group that will receive IL-2 will begin to receive          the treatment 24 hours after the cell infusion, every day for 5 days. All participants          will receive filgrastim injections to help the body produce more white blood cells.        -  Participants will recover in the hospital for about 7 to 12 days after the cell infusion          or the last dose of IL-2. Participants will continue to receive medications and provide          blood and tumor samples for testing.        -  Participants will have regular followup visits to assess the effects of the treatment.   "
153707|NCT01271894|"     Safety and efficacy are key issues in antiretroviral therapy (ART) selection. Efavirenz (EFV)     is an important component of combination ART in treatment naive individuals. Like many drugs,     there are inter-individual differences in the efficacy and tolerability of EFV. The Encore1     study provides an opportunity to examine the pharmacokinetics (PK)(processes by which a drug     is absorbed, distributed, metabolized, and eliminated by the body) of EFV in blood samples     collected over a 24-hour dosing interval in participants receiving either standard 600 mg or     reduced 400 mg dose EFV once daily.   "
157429|NCT01223352|"     The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two     dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial     hypertension (PAH) <12 years of age.   "
153708|NCT01271881|"     Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two     areas of particular problems are the terminal portion of the cephalic vein near the shoulder     and the central veins in the chest. Although angioplasty is standard of care the treated     narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your     dialysis access functional. Recently there has been introduction of a new technology called a     covered stent graft. Initial studies suggest that placing this device across the area of     narrowing leads to dialysis access staying open longer and needing less angioplasty     treatments.      This study is designed to compare angioplasty (standard of care) versus using a covered stent     graft. The investigators will then look at the dialysis records and future fistulograms to     see if there is decreased flow through the fistula at 3, 6 and 12 months after the initial     procedure.   "
153709|NCT01271868|"     The Study's Primary Objective is to evaluate the pharmacokinetics, safety (acute effects     associated with infusions, and inhibitor development) and efficacy (breakthrough bleeding and     control of hemorrhaging during prophylaxis) of IB1001 in previously treated pediatric     subjects with hemophilia B.   "
153710|NCT01271855|"     Hypothesis:      The routine use of belladonna/opium (B&O) suppositories will improve patient's self-reported     pain control in the first 24-hours after delivery.      Commonly employed methods of controlling post-partum pain include opioid analgesics,     non-steroidal anti-inflammatories, acetomenophen, and topical analgesics. Pain medication is     generally administered via oral or IV route. Several studies have investigated suppositories     as an alternative method of improving pain following delivery.      Rectal analgesia provides a means of improving pain control through local effects on the     perineum and uterus while possibly decreasing systemic absorption, which may in turn decrease     systemic side effects and transmission to the newborn infant through breast milk. B&O     suppositories contain two medications that could potentially decrease post-partum pain. This     quality may significantly improve pain from uterine contractions during the post-partum     period.   "
153711|NCT01271842|"     Influenza A (H1N1) v2009 infection was responsible throughout the world of viral pneumonia     and severe pulmonary edema requiring rescue therapeutics such as extracorporeal oxygenation.     To date, no data exist on the outcome of patients having developed acute respiratory distress     syndrome (ARDS) due to influenza A (H1N1) v2009, and in particular in patients with very     severe lung injury requiring extracorporeal oxygenation. Although data exist on long-term     outcome of survivors of ARDS, the patients included in the observational studies were     heterogeneous with various underlying disease. Moreover, no study compared the outcome of     survivors of ARDS according to the need or not of extracorporeal oxygenation. We therefore     conducted this prospective case-control study to compare the long term pulmonary and extra     pulmonary function in 2 groups of patients, one with severe ARDS due to H1N1 requiring     extracorporeal oxygenation (case), and the second with ARDS due to H1N1 but without need for     extracorporeal oxygenation (control). Eighteen case patients with inclusion and without     non-inclusion criteria were selected from our national registry, and 32 controls (with     inclusion and exclusion criteria) were matched on age, sex, and body mass index. All 48     patients will be contacted and asked to participate. Patients will be evaluate at least 9     months after ICU discharge, looking for health-related quality of life, measured by the     Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36), post traumatic     stress disorder, assessed by the Impact of Event Scale Anxiety, and depression, assessed by     the Hospital and Depression Score. Pulmonary function testing, including VO2 max test on a     static bike will be performed. Muscle weakness will be clinically evaluated by the medical     council research (MRC) test, with an additional electromyography if the result of the test     was <48/60. A CT-scan will be performed, looking for lung abnormalities (fibrosis...).     Albumin and prealbumin will be measured to evaluate the nutritional status.      Primary outcome measurement is carbon monoxide diffusion capacity. The primary hypothesis is     that patients with extracorporeal oxygenation will have a carbon monoxide diffusion capacity     lower than patients without extracorporeal oxygenation (15% difference between groups).     Inclusion of 13 patients in the case group and 26 patients in the control group will allow     testing this hypothesis with a statistical power of 80% (standard deviation 15%). Secondary     outcome measures will be the quality of life, the presence or not of post-traumatic stress     disorders, of anxiety and/or depression, the results of pulmonary function testing, of the     CT-scan, and of muscle testing. All results will be compared in patients with and without     extracorporeal oxygenation.   "
153712|NCT01271829|"     The purpose of this study is to examine the effect of incorporating avocados in meals on     post-ingestion glycemic index, insulin response, sensations of satiety and on     appetite-related gastrointestinal peptide and hormone release. Also the effect of consuming     avocado containing meals on the caloric intake of participants in subsequent eating episodes     will be explored.      Each subject will participate in one intervention for one day, wait one or two weeks, come     for another intervention, wait one or two weeks and come for a final intervention- three in     total. Participants will be randomly assigned to one of six treatment sequences. Postprandial     response to the control and two avocado-containing test meals will be assessed and compared     using a 3 x 3 single blind cross-over design. The Subjects will be between 25 and 60 years     old, female or male, with a BMI of 23 to 32, stable weight, no sports involvement,     non-smoking and not dependent on caffeine. Thirty subjects will be recruited.   "
153713|NCT01271816|"     Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited condition     characterized by life threatening heart racing, presenting with palpitations, cardiac arrest     (collapse requiring an ambulance) or sudden death. The disease affects the right ventricle,     the part of the heart that pumps blood to the lungs. ARVC is diagnosed with a wide range of     tests that focus on the pumping function and the electrical signals from the right ventricle.     These factors are summarized in a score that forms the ARVC Task Force Criteria. Genetic     testing has identified 5 different genes that lead to ARVC, which are detected in about 60%     of patients with ARVC. This allows doctors to test family members of the patient with ARVC to     determine if they are at risk of developing the condition. Currently, family members undergo     testing that includes imaging and electrical tests such as a 24-hour monitor to determine if     they have evidence of ARVC. With increasing frequency, family members are found to have the     gene that may lead to ARVC, but little or no evidence that their hearts are affected. This     may be because the family member is too young to develop the condition, or that other factors     that we do not understand have protected them from developing it.      The PREPARE study will study 100 patients that carry a gene that can lead to ARVC, but do not     have anything more than minor evidence that the condition is present. These patients will not     have heart racing on their initial 24-hour monitor. These patients will undergo long term     monitoring with an implanted heart monitor that is inserted with a minor surgical procedure,     which will detect abnormal heart rhythms that may provide a clue that heart racing from ARVC     is present that is not detected with a 24-hour monitor that is performed on an annual basis     (St. Jude Confirm implantable loop recorder). These patients will be enrolled in 10 adult and     pediatric centers across Canada, and followed for 3 years after their heart monitor is     implanted. If heart racing is detected, patients will discuss these results with their doctor     to discuss what it means to them.   "
153714|NCT01271803|"     This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will     evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600     mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E     mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have     progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are     eligible. Participants will be assigned to different cohorts with escalating oral doses of     vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage     [DES] and Cohort Expansion Stage [CES]) and the anticipated time on study treatment is until     disease progression, unacceptable toxicity or any other discontinuation criterion is met.   "
157439|NCT01223222|"     The purpose of this study is to evaluate the safety and tolerability of Lytixar™ applied     topically to uncomplicated skin infections.      Three dose levels of Lytixar™ (1%, 2% and 5%) versus placebo will be tested.   "
153717|NCT01271764|"     Tumor invasion and metastasis are the major causes of cancer-related death. Some studies have     found that histone methyltransferases, such as EZH2, specifically affect metastasis in     breast, gastric and prostate cancer. The functional roles of other members of the HMT family     such as G9a in cancer remain obscure. Therefore, the investigators will investigate whether     G9a have a role in recurrence/metastasis of endometrial cancer.   "
153718|NCT01271751|"     The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum     Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels     compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to     assess the tolerability and safety of once-a-day administrations of oral doses of GFT505     during 28 days.   "
153719|NCT01271738|"     The goal of this study is to compare two different types of breast surgery. In the first     type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and     some of the tissue around the tumor called margins. The amount of breast tissue removed is     similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor     is too close to the margin. The primary goal of this study is to see if the additional     margins can decrease the need to return to the operating room. Both types of surgery are well     accepted, and participating in the study would not give you a better chance to cure the     cancer. At present, most breast surgeons remove the tumor without the additional margins. For     all patients who have this operation, there is a high incidence of return to the operating     room for margins re-excision: as many as 40% as patients can have a re-operation.      At present, we do not know if taking the additional margins prevents the cancer from     returning in the breast or not. If the cancer comes back in your breast, this is a recurrence     and your breast will have to be removed (mastectomy).   "
153720|NCT01271725|"     The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW     2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who     progress on afatinib monotherapy within this trial) as treatment in patients with     HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the     neoadjuvant or adjuvant setting   "
153721|NCT01271712|"     A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best     supportive care versus placebo plus best supportive care for subjects with metastatic and/or     unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite     prior treatment with at least imatinib and sunitinib.      The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival     Follow up Period.      Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of     every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive     best supportive care which excludes any disease specific anti cancer therapy such as any     kinase inhibitor, chemotherapy, radiation therapy, or surgery.      Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3     months (through month 6), and every 8 weeks until the end of treatment, or more frequently if     clinically indicated. Tumor assessments include CT or MRI and will be performed until tumor     progression is seen in a central radiology review.      Subjects receiving placebo who experience disease progression may be offered active     treatment.      Subjects who experience progression during regorafenib treatment may continue open label     treatment.      All subjects will enter the Survival Follow-up Period upon discontinuation of randomized     study treatment.   "
153722|NCT01271699|"     The association of Multiple Sclerosis (MS) and Fabry disease is known from own clinical     experiences as well as from case reports in the literature, where symptoms and suspicious     results in the brain MRI led to the misdiagnosis of Fabry patients as MS. Remarkably, those     patients almost never showed oligoclonal bands or an intrathecally derived IgG-production was     wrongly assumed due to misinterpretation of CSF results. Where oligoclonal bands were     present, concomitant diagnoses had to be discussed. Furthermore, those patients showed no     involvement of the spinal cord, as evidenced by MRI. Beside the possible complications of a     not-effective and not-necessary MS therapy, those patients are at risk of irreparable organ     damage due to the delayed implementation of enzyme replacement therapy for Fabry disease.   "
153723|NCT01271686|"     This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in     patients with glaucoma or ocular hypertension   "
153724|NCT01271673|"     Breast cancer is the most common cancer among women residing in majority of the urban areas     in India. The deaths due to breast cancer are mainly a result of late presentation of the     symptoms due to lack of awareness of the signs and symptoms of the disease and lack of     knowledge of performing BSE. The BSE technique can be a good tool for improving the awareness     about the symptoms of breast cancer. Hence, we propose a pilot study of short duration (3     months follow-up), to assess the level of compliance to BSE and assess the various reasons     for non-compliance. Based on the results of this study a long term cohort study will be     planned with similar objectives.   "
153725|NCT01271660|"     Muscle cramp is defined as a paroxysmal, involuntary, and painful contraction of skeletal     muscle. Cirrhotic patients can encounter with muscle cramp frequently, which might be     associated with poor quality of life. Gabapentin can be prescribed for muscle cramp. However,     patients with liver cirrhosis have limited access to gabapentin which is metabolized     primarily in liver.      Pregabalin with a similar mechanism of action to gabapentin undergoes negligible metabolism     owing to its improved pharmacokinetic properties. Thus, pregabalin might be a promising     therapeutic option for patients with liver cirrhosis who are suffering from muscle cramp and     susceptible to drug-induced hepatotoxicity.      Therefore, the investigators hypothesize that pregabalin could effectively reduce painful     symptoms derived from muscle cramp. In the current study, the investigators are going to     evaluate the efficacy and safety of pregabalin by comparing outcomes between two groups     (treatment group vs. placebo group).   "
153726|NCT01271647|"     The purpose of this study is to evaluate the efficacy and safety of the classic yin and yang     tonic formula for osteopenia and to research the mechanism of efficacy.   "
153727|NCT01271634|"     The pathophysiologic basis of hemifacial spasm is cross-transmission between different     branches of the facial nerve. The hypothesis is that the cross-transmission is mediated by     the sympathetic nerve fibers on the surface of the offending artery. The abnormal potential     from the offending vessel to the facial muscles will be detected on hemifacial spasm     patients, so as to determine if the sympathetic nerve fibers take part in the circuit of     cross-transmission.   "
153728|NCT01271621|"     Tracheal intubation with traditional Macintosh laryngoscope is associated with increase in     intraocular pressure along with tachycardia and hypertension. These effects are not desirable     in ophthalmic patients especially in patients with glaucoma. GlideScope video laryngoscope     system is a new approach for laryngoscopy and tracheal intubation. It does not require a     direct line of sight to the glottis when intubating with the Glidescope and as a result     intubation is much less stimulating to the patient. Therefore GlideScope video laryngoscope     assisted intubation could be a preferable technique for intraocular surgery offering     advantages in terms of intraocular pressure and cardiovascular stability.   "
153729|NCT01271608|"     Comparing the pain intensity on a numeric scale (0-10) with intramuscular and subcutaneous     injection between a retractable fixed syringe needle and the technique involving needle     exchange; Comparing bruise formation following administration of insulin subcutaneous     injections between RFS and the conventional technique.      Method Study site A clinical trial was conducted in two medical-surgical units in a hospital     in the period from June 15th to November 30th, 2009, after approval by the Ethics and     Research Committee.      Intervention In a group of patients the investigators used syringes with retractable fixed     needle to administer subcutaneous and intramuscular injections. In the group of control, the     investigators used the standard technique to administer medications.      Population of study Patients were sequentially enrolled through a lottery system of exposure     using random numbers kept in sealed, opaque envelopes.      Sampling design and sample size Subcutaneous injection The sample size was based on the     expected proportion of bruising following the injection. It was expected that 40% of patients     would show bruising with the conventional technique and 20% with the technique under study     for subcutaneous applications. With an alpha error of 5% (p = 0.05) and power of study of 80%     (beta error of 20% or 0.2) 240 patients were included, 120 in each group.      Intramuscular injection The sample size was based on the proportion of patients with moderate     to severe pain. It was considered normal the incidence of moderate to severe pain in 30% with     a needle exchange, whereas it was considered an increase of up to 40% with the retractable     fixed needle. The investigators included 500 patients in each group.   "
153730|NCT01271595|"     There is inconclusive evidence whether acupuncture treatment is effective in the treatment of     seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture in     SAR are only poorly understood. It was hypothesised that the therapeutic mechanism of     acupuncture is related to changes in autonomic function. AUTO-ACUSAR is a sub-study of the     DFG-funded three-arm randomized controlled trial ACUSAR trial investigating the efficacy of     acupuncture vs. sham acupuncture vs. rescue medication in SAR. The aim of AUTO-ACUSAR was to     investigate short and long-term effects of acupuncture vs. sham acupuncture on autonomic     function in a sub-group of ACUSAR patients. Baseline values were compared to data from     matched healthy controls.   "
153731|NCT01271582|"     The purpose of this study is to investigate the association between UGT1A1 polymorphisms and     neutropenia and diarrhea in Korean patients with advanced colorectal or gastric cancer     treated with FOLFIRI regimen.   "
153732|NCT01271569|"     The aim of this study was to evaluate the pharmacodynamics, safety, and tolerability of     Fospropofol disodium up to a dose producing maximal hypnotic effect as defined by     electroencephalogramderived assessment (Bispectral Index [BIS]) and to compare the dynamic     properties of PropofolF to those of Propofol.   "
153733|NCT01271556|"     The cardiovascular component associated with COPD plays a major role in prognosis of the     disease, being responsible of 25% of the deaths. Experimental and initial clinical data     suggest that beta-adrenergic agonists accelerate clearance of excess fluid from the alveolar     airspace, with potential positive effect on cardiogenic pulmonary edema.      The aim of this study was to investigate the effects of a long-acting beta-2 agonist,     salmeterol, on alveolar fluid clearance in COPD patients by evaluating the diffusive and     mechanical lung properties. Our experimental model to test alveolar fluid clearance was rapid     saline intravenous infusion.      Ten COPD and 10 healthy subjects treated with salmeterol or placebo 4 hours before the begin     of the study were evaluated, in four non consecutive days, just before and after a saline     infusion or a similar period without infusion.      Both in COPD and healthy subjects rapid saline infusion, with placebo or salmeterol     premedication, lead to a significant decrease of DLCO and FEV1. Nonetheless, salmeterol     pretreatment lead to a significant reduction of the impairment of gas exchange due to saline     infusion (-64% of DLCO reduction in comparison with placebo), whilst it did not affect the     changes in FEV1. In the control setting, with no infusion, we did not find any significant     change of both DLCO and mechanical properties of the lung.      In conclusions, in COPD patients salmeterol appears to provide a protective effect against an     acute alveolar fluid clereance challenge secondary to lung fluid overload providing an     intriguing mechanistic explanation for the benefits observed in larger trials.   "
153734|NCT01271543|"     Because of its simplicity of function and reliability, direct laryngoscopy it is routinely     used for endotracheal intubation during general anesthesia. However, direct laryngoscopy is     fraught with concerns for cardiovascular stimulation during induction of general anesthesia.     This can be attributed to the placement of the laryngoscope blade into the vallecula and then     applying force in an upward direction to expose the glottic opening. The average force     necessary for visualization of the glottic opening is approximately 5.4kg. This can lead to     significant pressor responses and tachycardia though stimuli to supraglottic region.      An alternative airway management device is the Shikani optical stylet (SOS). It is an     effective, safe and reusable intubation device that has been shown to be effective in cases     of difficult intubation. It consists of a fiberoptic bundle within a J - shaped malleable     stainless steel sheath. At the proximal end of the sheath is an eyepiece with an attachment     to a light source. An adjustable tube stop firmly affixes the endotracheal tube to the     stylet, and has a port to be able to deliver oxygen. (4) The operator inserts the tip of the     stylet with the loaded endotracheal tube into the patient's oropharynx and under direct     visualization through the eyepiece, is able to visualize the vocal cords. Because the end of     the stylet is at the end of the endotracheal tube, it can be directly visualized to be     entering trachea past the vocal cords.      The investigators hypothesize that endotracheal intubation performed by the aid of SOS by     minimizing oropharyngolaryngeal stimulation will result in fewer hemodynamic changes in     patients with normal airways as compared with the MacIntosh laryngoscope.   "
153735|NCT01271530|"     The aim of this study is to investigate the effect of upper limb cardiovascular training on     fitness, energy cost of walking, fatigue and pain in polio survivors. Polio survivors often     have difficulty accessing aerobic forms of exercise due to limitations in mobility, pain     associated with walking and fatigue. This can result in becoming physically unfit and places     polio survivors at risk of secondary heath problems due to inactivity. A large percentage of     polio survivors have lower limb involvement but have strong arms. The participants in this     study will exercise at home using simple arm cycles for 8 weeks. They will attend for     assessment on two occasions. All exercise will be prescribed by a Physiotherapist and     includes measures to ensure safety while exercising at home.   "
153736|NCT01271517|"     Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve     glycemic control during the first year of treatment of children/adolescents with type 1     diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal     balance of the GH-IGF-axis.      This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age,     newly diagnosed with T1DM. The investigators will investigate whether the use of long-acting     basal insulin analogs Lantus (Glargine) or Levemir (Detemir) during the first year of     treatment results in improved glycemic control (HbA1c) compared with Insulatard (NPH insulin)     when given in a meal insulin therapy regimen with rapid acting Novorapid (insulin aspart).     The investigators will explore possible mechanisms of action by determining remaining     endogenous insulin production and changes in the GH-IGF-axis. The investigators will also     assess changes in body composition and evaluate quality of life in each treatment arm.   "
153737|NCT01271504|"     The purpose of this study is to determine whether patients with hepatocellular carcinoma who     receive either E7050 administered with Sorafenib or Sorafenib alone experience greater     benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.   "
153738|NCT01271491|"     Bronchiolitis is a potentially severe infection of the airway in infants and children, and     among the most frequent diagnoses leading to pediatric intensive care unit admission in     infants. This acute infection is caused by an array of viruses, but respiratory syncytial     virus (RSV) is the most frequently implicated. The majority of infants hospitalized with     bronchiolitis are previously healthy, and half of infants intubated and mechanically     ventilated for respiratory failure due to RSV bronchiolitis have no previously identified     risk factors. It is likely, therefore, that other factors, particularly genetic heterogeneity     of the host, contribute to disease severity. However, no previous study has investigated the     association of genetic variants with respiratory failure in children with bronchiolitis.     Several categories of candidate genes have emerged as potentially important in the     pathogenesis of the disease. Specifically, genetic polymorphisms of surfactants, pattern     recognition receptors, receptor adhesion molecules, and cytokines have been examined. The aim     is to evaluate these polymorphisms to determine their association with respiratory failure in     a cohort of more severely ill children with bronchiolitis.   "
153739|NCT01271478|"     The aim of this study was to compare the dual use of telmisartan and captopril vs the     individual use of such drugs and placebo on the systemic inflammation of patients on     hemodialysis (HD).   "
153741|NCT01271452|"     This study will evaluate the safety and efficacy of two different types of botulinum toxin     type A for the treatment of glabellar frown lines.   "
191642|NCT00353483|"     The main purpose of this study is to compare genetic markers present on tumor cells before     and after chemotherapy.   "
153742|NCT01271439|"     This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate     acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy     in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship     between patient outcome and EGFR gene copy number, expression and mutation.   "
153743|NCT01271426|"     To determine whether complement factor H (CFH) and age-related maculopathy susceptibility 2     (ARMS2) genotypes have a pharmacogenetic effect on the treatment of polypoidal choroidal     vasculopathy (PCV) with ranibizumab.   "
153744|NCT01271413|"     This research is being done to learn if computer tasks that challenge the brain (cognitively     stimulating tasks) can improve memory and other types of thinking. The study will compare the     effects of different versions of the computer tasks. It also will compare the task     performance of different groups of people.   "
153745|NCT01271400|"     The aim of this study is to track the outcome from the patients who had embryo     cryopreservation as part of their Advanced Reproductive Technology (ART) treatment at West     Coast Fertility Centers.   "
153746|NCT01271387|"     The purpose of this research study is to understand whether there is any difference in the     amount of tasimelteon (including its breakdown products) in the blood in individuals with     mild or moderate liver disease compared to individuals who have normal liver function.   "
153747|NCT01271374|"     The purpose of the study is to compare the effects of Azor (a combination of amlodipine and     olmesartan) with Hyzaar ( a combination of losartan and hydrochlorothiazide) on the thin     lining on the inside of blood vessels. These cells help keep blood vessels healthy and blood     pressure normal.   "
153748|NCT01271361|"     The purpose of the study it to evaluate whether primary percutaneous coronary intervention     (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy     increases minimal flow area after stenting for treatment of patients presenting with     ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.   "
153749|NCT01271348|"     Comparison of the effect of etoricoxib to placebo on muscle pain caused by eccentric     contractions   "
153750|NCT01271335|"     A prospective, three-center, phase I safety and tolerability dose escalation study,     evaluating 28 subjects in 4 discrete dose cohorts of acute intracoronary injected collagenase     ranging from 300 - 1200 µg prior to routine standard-of-care percutaneous revascularization     procedures in subjects with chronic total coronary artery occlusions (CTOs).   "
154916|NCT01256125|"     Allogene MSCs transplantation will be performed in patients with chronic liver diseases     through peripheral vein and therapeutic effects including short-term effects and long-term     follow-up will be compared and investigated.   "
153751|NCT01271322|"     Prospective, single-center, nonrandomized, explorative imaging study evaluating the value of     PET as a predictor of histopathological response in metabolic non-responders Patients with     resectable AEG (adenocarcinoma of the esophagogastric junction) type I and II (cT3/4 and/or     cN+ and cM0)      Metabolic non-responders, showing a <35% decrease of SUV (standardized uptake value) two     weeks after the start of neoadjuvant chemotherapy are eligible for the study and are taken to     intensified taxane-based RCT (radiochemotherapy) before surgery. 18FDG-PET scans will be     performed before (=Baseline) and after 14 days of standard neoadjuvant therapy as well after     the first cycle of Taxotere/Cisplatin chemotherapy (=PET1) and at the end of intensified     radiochemotherapy (PET2).      Tracer uptake will be assessed semiquantitatively using standardized uptake values (SUV). The     percentage difference Delta SUV=100(SUVBaseline-SUVPET1)/ SUVBaseline will be calculated and     assessed as an early predictor of histopathological response. In a secondary analysis, the     association between the difference SUVPET1 - SUVPET2 and histopathological response will be     evaluated.   "
153752|NCT01271309|"     The present project aims to determine whether a deficit in migration of stem cells could be     implicated in the failure to mount an adequate collateralization after Myocardial Infarction     (MI) and thereby facilitate the development of post-ischemic heart failure (HF) and to     dissect underlying molecular mechanisms. Furthermore, the investigators wish to determine the     predictive value of stem cell migration assay in patients with MI.   "
153753|NCT01271296|"     Addison's disease is a rare disease, wherein the adrenals can not produce sufficient steroid     hormones (cortisol and aldosterone). Patients with Addison's disease report impaired     subjective health status, and they have increased all-cause mortality. Conventional therapy     is by oral replacement of glucocorticoid and mineralocorticoid hormones, but this strategy     imperfectly mimic the diurnal cortisol variations, and render the patients both over- and     under-treated. Anecdotally, some patients with adrenal insufficiency may benefit from the use     of various nutritional compounds. We hypothesised that liquorice and grapefruit altered the     metabolism and absorption of cortisone acetate.   "
153754|NCT01271283|"     This phase II clinical trial is studying how well lenalidomide works in treating patients     with high-risk chronic lymphocytic leukemia. Biological therapies, such as lenalidomide, may     stimulate the immune system in different ways and stop cancer cells from growing.   "
153755|NCT01271270|"     Background:        -  Wet age-related macular degeneration (AMD) occurs when abnormal blood vessels grow in          the back of the eye, and leak blood and other fluids that damage the eye, produce          scarring, and lead to blindness. People diagnosed with wet AMD have increased production          of a body chemical called vascular endothelial growth factor (VEGF). VEGF is important          in the formation of blood vessels in the body, and decreasing the production of VEGF is          believed to help wet AMD patients by preventing or slowing the growth of the abnormal          blood vessels. Anti-VEGF drugs have been used to decrease the production of VEGF, but          some people do not respond completely to these drugs.        -  A protein in the body called mTOR also plays a critical role in regulating how cells          divide and grow and obtain their blood supply. The experimental chemical Palomid 529          inhibits the production of mTOR. Researchers are interested in determining whether          Palomid 529 is safe and can help individuals with wet AMD who have not completely          responded to anti-VEGF treatments.      Objectives:      - To evaluate the safety and effectiveness of Palomid 529 as a treatment for wet age-related     macular degeneration in individuals who have not responded to standard anti-VEGF treatments.      Eligibility:      - Individuals with wet age-related macular degeneration in at least one eye that has not     responded to standard anti-VEGF treatments.      Design:        -  Prior to the first visit, participants should have been seen at the National Eye          Institute clinic under a screening or teaching protocol, or NIH protocol 08-EI-0103,          High Speed Indocyanine Green Angiography Findings in Induction Regimen of Intravitreal          Ranibizumab Injection for Neovascular Age Related Macular Degeneration. One eye will be          designated as the study eye to receive the Palomid 529 treatment.        -  Participants will have a full physical examination and medical history, a full eye          examination to evaluate eye health and vision, angiography to examine the blood vessels          in the eyes, and blood and urine tests during the study        -  Participants will receive an injection of Palomid 529 into the study eye every 4 weeks          during the study, for a total of three injections. Participants may also receive          anti-VEGF injections such as ranibizumab (Lucentis ) or bevacizumab (Avastin ) in the          study eye 12 days before and 12 days after the Palomid 529 injection.        -  Participants may have standard-of-care treatments for the non-study eye if it has wet          AMD as well, but may not receive experimental treatments in the non-study eye while they          are in this study.        -  Participants will return for long-term follow-up examinations as directed by the study          researchers.   "
153758|NCT01271231|"     Diabetes is a metabolic disorder that affects the uptake of glucose into cells. This causes a     cascade of systemic alterations that may lead to kidney failure, cardiovascular     complications, altered tissue healing, retinopathies and gangrene. Diabetes is also     associated to increased susceptibility to infections and inflammation.      It has been observed that diabetic patients suffer more often from oral infections such as     periodontal disease. Periodontal disease is an infectious-inflammatory disease that leads to     destruction of the surrounding tissues of the tooth. It is proposed that the mechanisms     responsible for systemic complication are implicated in the development of periodontal     disease. This has been evaluated in studies where diabetic patients showed increased levels     of inflammatory cytokines, subgingival bacteria and limited response to treatment. Its has     also been suggested that established periodontitis in the diabetic patient leads to insulin     resistance due to infection and liberation of cytokines from periodontal tissues and thus     worsening the diabetic condition.      This study is aimed to establish the response to periodontal treatment with antibiotics and     the kinetics of glucose levels in diabetic patients.   "
153759|NCT01271218|"     Background: Exercise, weight loss, and dietary supplementation of glucosamine and chondroitin     (GC) have been reported to improve functional capacity in individuals with knee     osteoarthritis (OA). The purpose of this study was 1.) to determine whether women with knee     OA who follow a higher protein diet observe more favorable changes in body composition and/or     markers of health compared to those following a standard higher carbohydrate-based diet; and,     2.) to determine whether dietary supplementation of glucosamine and chondroitin during a     weight loss and fitness program lessens symptoms of pain, improves functional capacity,     and/or promotes greater health benefits in women with knee OA. It was hypothesized that both     groups would experience beneficial changes in body mass, body composition, and markers of     health. However, greater benefits would be observed in those following a higher protein diet     while supplementing the diet with glucosamine and chondroitin.   "
153785|NCT01270880|"     Hsp90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins     needed for cell growth. This phase II trial is studying how well Hsp90 inhibitor STA-9090     works in treating patients with metastatic hormone-resistant prostate cancer previously     treated with docetaxel-based chemotherapy   "
153786|NCT01270867|"     To determine if the Trevo Retriever is as good or better than the Merci Retriever in     restoring blood flow to the brain of a patient experiencing an acute ischemic stroke in a     large vessel.   "
153760|NCT01271205|"     Abstract Pneumonia is a leading cause of severe morbidity and mortality among adults. During     the last two decades, several scores were developed to evaluate the probability of morbidity     and mortality among patients with community acquired pneumonia (CAP), such as the PORT score     and the CURB65. Recently, several studies showed that elevated Red Cell Distribution Width     (RDW) could be used as a prognostic tool for predicting severe morbidity and mortality among     patients with cardiac diseases.      RDW is a quantitative measure for red blood cell (RBC) size variability. Recent studies have     suggested that high levels of RDW are in association with higher mortality among     cardiovascular patients.      RDW has not yet been studied as a prognostic sign in CAP. The goal of this study is to     examine the role of RDW as a prognostic factor for severe morbidity and mortality among     patients who were hospitalized with CAP , independently to Hemoglobin levels, renal function     and inflammatory markers.   "
153761|NCT01271192|"     RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for     resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy     is still unknown.      PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed     by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative     chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect     of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.   "
153762|NCT01271179|"     The study was designed to investigate whether, compared with conventional sole perfusion with     high-viscosity solution of University of Wisconsin (UW), sequential perfusion of liver grafts     with low-viscosity and high-viscosity preservation solutions could further decrease the     incidence of nonanastomotic biliary strictures (NAS) after liver transplantation.   "
153763|NCT01271166|"     This is a Phase I, dose finding, multicentre study evaluating the maximal tolerated dose of     Glivec® in combination with mFOLFOX-Avastin®. Patients will be enrolled into each dose level     in 3 patient cohorts. Additional cohorts will be enrolled, or dose levels opened, subject to     the toxicities observed. Once the MTD has been determined the dose level below will be     re-opened and extra patients, to a total of 15, will be enrolled.   "
153764|NCT01271153|"     The investigators hypothesize that dobutamine is able to revert negative redistribution of     flow by inducing a selective vasodilatory effect on hypoperfused territories, particularly at     the sublingual and gastric mucosa, and at the peripheral tissues.      The investigators designed a randomized, cross-over, placebo-controlled study looking at the     acute physiologic effects of 5 mcg/kg/min fixed-dose of dobutamine on cardiac function,     microcirculation, gastric mucosal, hepatosplanchnic, and peripheral perfusion in septic shock     patients.   "
153775|NCT01271010|"     This multi-center, single-arm study will evaluate the efficacy and safety of rituximab in     combination with fludarabine and cyclophosphamide in participants with B-cell chronic     lymphocytic leukemia (CLL) and favorable somatic status.   "
153776|NCT01270997|"     The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in     combination with Methotrexate in patients with rheumatoid arthritis.   "
153777|NCT01270984|"     The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic     characteristics between the Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T) when     administered a single-dose to healthy volunteers.   "
153778|NCT01270971|"     The purpose of this study is to determine whether AN2690 topical solution is a safe and     effective treatment for onychomycosis of the toenail.   "
153808|NCT01270581|"     The primary objective is to determine whether High Flow Nasal Cannula (HFNC) is a superior     respiratory modality for neonates ≥36 weeks with transient tachypnea of the newborn (TTN)     when compared to the standard of care modality (NCPAP).   "
154216|NCT01265264|"     The purpose of this study is to determine whether ulodesine and allopurinol combined for 12     weeks are effective in treating gout in patients who are not adequately responding to     allopurinol alone.   "
153765|NCT01271140|"     Insulin resistance is one of the key factors in defining a progressive course of chronic     Hepatitis C virus (HCV) infection and hepatic fibrosis. Multiple trials have targeted insulin     resistance as an adjuvant way to manage hepatitis C liver disease with promising results.      Long term therapy using high dose insulin was shown to significantly reduce insulin     resistance in obese patients. In cardiac and critically ill patients, long term insulin was     shown to produce better outcomes mainly by reducing the overt inflammatory response.     Furthermore, initial results of ongoing trials are revealing more benefits of insulin     therapy. Using the (hyperinsulinimic normoglycemic clamp) for eight hours on patients     undergoing major liver resection was able to maximize their liver function post-operatively.     This trial also demonstrated inhibition of the inflammatory response, improvement in liver     glycogen, inhibition of apoptosis and stimulation of liver regeneration.      Putting in mind the potential ability of the liver to regenerate and regain better function.     The anti-inflammatory properties of insulin therapy along with its ability to reduce insulin     resistance over time has led us to see the potential benefits of using insulin therapy on     patients with chronic hepatitis C virus liver cirrhosis. Insulin will target the     pathophysiology of the disease at a cellular and a molecular level.      The investigators theorize that long-term high insulin therapy would be able to promote     better liver function and slow down fibrosis and injury in this population of patients.   "
153766|NCT01271127|"     Survivors of Hodgkin Lymphoma (HL) are known to have an increased risk of developing late     treatment sequelae such as cardiovascular events due to coronary artery disease. At present     no active screening is performed in these patients since it is not known whether screening     and subsequent treatment by means of revascularization is effective in reducing the risk of     cardiovascular events in symptomatic individuals. In the trial the efficacy and therapeutic     consequences of screening for coronary artery diasease by multi-slice CT (MSCT) among     asymptomatic HL survivors will be evaluated.   "
153767|NCT01271114|"     In hypotensive septic patients with controlled source, an hemodynamic management protocol     including hypertonic saline (HS)and terlipressin improves MOD (Multiple Organ Dysfunction)     Score by at least 3 points compared to the use of physiologic saline and norepinephrine.      The appropriate design for this trial would be factorial. For the time being, will consider     de intervention as a whole unit for this pilot study. In the future an appropriately sized     factorial multicentric study shall be necessary.      Other goals of the pilot study:        1. HS restores preload parameters adequately        2. HS associated with terlipressin normalizes blood pressure in septic shock        3. HS associated with terlipressin maintains plasma sodium levels 130-155mEq/L        4. There is an inverse relationship between plasma sodium and procalcitonin levels        5. HS increases plasma levels of vasopressin (AVP)        6. HS rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)   "
153768|NCT01271101|"     The primary objective of the EASY-CHINA Registry is to describe the clinical epidemiology of     Chinese patients with NSTE-ACS, to evaluate their current anticoagulation management in     China, and the resources used for it.   "
153769|NCT01271088|"     Peritonitis is currently one of the leading complications of continuous ambulatory peritoneal     dialysis (CAPD). Aminoglycosides and vancomycin are used in the treatment of CAPD peritonitis     despite their potential risk for ototoxicity. NAC is a molecule used in the treatment and     prophylaxis of many diseases related to oxidative stress. The aim of this study was to     examine whether ototoxicity due to antibiotics used in the treatment of CAPD peritonitis can     be prevented by N-acetylcysteine   "
153787|NCT01270854|"     The purpose of this study is to determine whether an intravenous salt solution called     Plasmalyte causes less abnormality of the body's acid levels than a solution called Normal     Saline.   "
153770|NCT01271075|"     This is a double-blind, triple cross-over, placebo-controlled study to assess the efficacy,     mechanisms, and safety of treatment with the antihistamine bilastine in patients with cold     contact urticaria (CCU).      Efficacy is primarily assessed by a change in critical stimulation time thresholds (CSTT) and     critical temperature thresholds (CTT) after treatment with different dosages of bilastine (20     mg, 40 mg, 80 mg). Following a baseline period of 2-4 weeks, patients are randomized to     either group A or group B. In group A they are given bilastine 20 mg, 40 mg, placebo and     bilastine 80 mg for 7 days each followed by a 14-day washout period at a time. In group B     they are given bilastine 80 mg, placebo, 40 mg and 20 mg for 7 days each followed by a 14-day     washout period at a time. CSTT and CTT testings are performed at each of 6 visits, skin     microdialysis for the assessment of mast cell mediators is performed at V2, V3 and V6. Visits     for investigator's assessments are scheduled at day -14 to -28, day 0, day 7, day 28, day 49,     and day 70. Overall a max. of 20 subjects with cold contact urticaria will be enrolled.   "
153771|NCT01271062|"     Bariatric operations such as the gastric bypass procedure provide a unique in vivo model of     improvement of pathological beta cell function. The presented double-centre study aims to     comprehensively investigate different aspects of beta cell function in patients with type 2     diabetes (T2DM) with a wide range of disease duration after gastric bypass. In parallel, our     project will address the aspects of changes in enteroinsular and adipoinsular axes as well as     the early and late changes of other defined parameters after gastric bypass surgery.   "
153772|NCT01271049|"     The prevalence of intestinal helminths is worldwide. This study will evaluate the     tolerability of a novel food product consumed by adults residing in an area endemic for     helminths.   "
153773|NCT01271036|"     This is a one week study designed to test the safety of a personal lubricant during in-home     use for subjects who perceive themselves as having sensitive skin.   "
153774|NCT01271023|"     The purpose of this study is to test an insulin management system (Control-to-Range (CTR)     system) in an inpatient setting to see if the system is safe and effective enough to test in     a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose     Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines     how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the     insulin.      The study will include two hospital stays consisting of meals and exercise scenarios. Both     hospital stays will be for 24+ hours during the day and night. The study will include about     50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.   "
154278|NCT01264679|"     To evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA)     with ferumoxytol.   "
153779|NCT01270958|"     Allergic rhinitis is an IgE-mediated, inflammatory disorder of the upper airway that occurs     following allergen exposure. Perennial Allergic Rhinitis (PAR) starts in early childhood and     occurs all year around. It's caused by allergy to the aerosolised droppings of house dust     mites and pet skin flakes (dander). Occasionally, indoor mould spores and, in rare cases,     food allergy can be causes.      Intranasal corticosteroids are highly effective medications for controlling the nasal     symptoms that accompany allergic rhinitis.      AVAMYS (TM) (fluticasone furoate aqueous nasal spray 100mcg) has been shown having effects on     nasal symptoms of seasonal and perennial allergic rhinitis and on the ocular symptoms of     allergic rhinitis and has been evaluated as effective and safe for treatment seasonal and     perennial allergic rhinitis by FDA. It is speculated that AVAMYS (TM) is also effective and     safe for Vietnamese patients. However before being used widely for patients across the     country, AVAMYS (TM) should be proved that it is safe for Vietnamese patients.      The objective of this study is to evaluate the safety of fluticasone furoate aqueous nasal     spray 110mcg once daily in adults with PAR.      This is a 6-week, open trial. A study center will be enlisted to recruit a minimum of 50 PAR     subjects.      At the visit 1, subjects who fulfill the inclusion criteria are eligible to be included in     the group to self-administer intranasal treatment of fluticasone furoate aqueous nasal spray     110 mcg once daily for 6 week. The subjects are instructed to administer two sprays from the     device into each nostril once daily every morning. Administration of the dose will be     performed by alternately spraying one spray to each nostril followed by a second spray to     each nostril. Subjects will not be permitted to take any anti-allergy or rhinitis medication     during the screening or treatment period.      Throughout the study, subjects will document their study drug administration/compliance, any     medical conditions experienced, and any concomitant medications taken. All subjects are     outpatients.      The safety assessments include a summary of the frequency and type of clinical adverse events     that occur during the study. In addition, hematology and chemistry analyses of blood samples     are also implemented. A physical examination and nasal examination are also performed and     vital signs collected. Twelve-lead ECGs are performed at all visits.   "
153780|NCT01270945|"     The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or     the time to restenosis in patients undergoing repeat peripheral artery revascularization     versus controls randomized to standard of care.   "
153781|NCT01270932|"     Primary:      • To validate the initial dosing recommendations for newly diagnosed MM (Mutiple Myeloma)     patients with various degrees of renal failure using pharmacokinetic studies      Secondary:        -  To evaluate the safety of lenalidomide and dexamethasone as induction therapy in          newly-diagnosed MM (Multiple Myeloma) patients with renal dysfunction using modified          dosing guidelines        -  To evaluate clinical response of lenalidomide and dexamethasone after 4 cycles using the          modified dosing guidelines        -  To evaluate the ability to collect stem cells after 4 cycles of lenalidomide and          dexamethasone induction therapy in MM (Multiple Myeloma) patients with renal failure   "
153782|NCT01270919|"     To demonstrate repair of the meniscus at 6 months, as evaluated by MRI, will be observed; and     clinical qualitative assessments will improve from preoperative to postoperative time points     with the BioDuct® Meniscal Repair Device.   "
153783|NCT01270906|"     Phase I dose finding study in solid tumors.   "
153784|NCT01270893|"     The goal of this clinical research study is to learn if Tasigna® (nilotinib) can cause tumor     cells to shrink and/or die in patients with GIST who are scheduled for surgery or may be     eligible for surgery. The safety of this drug will be studied. Researchers also want to use     imaging scans to study the changes in tumor size that may be caused by using nilotinib.   "
168675|NCT00036348|"     The purpose of this study is to learn if aripiprazole is effective in the treatment of     patients with a history of bipolar disorder.   "
153788|NCT01270841|"     The Purpose of the study is to determine the effects of Androxal on morning testosterone and     reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less     than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The     effects of Testim versus placebo on reproductive status will also be examined. Study subjects     must not be currently using a topical testosterone.   "
153789|NCT01270828|"     The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin     formulation versus placebo for patients with post herpetic neuralgia (Shingles)   "
153790|NCT01270815|"     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a     pregabalin controlled release tablet following a 400 to 500 calorie, 600 to 750 calorie, or     800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2)     evaluate the safety and tolerability of a single dose of a pregabalin controlled release     tablet following various sized lunches as compared to a single dose of the pregabalin     immediate release capsule.   "
153791|NCT01270802|"     Efavirenz, a commonly used HIV medication, may cause worsening vascular function and bone     problems. The purpose of this study is to determine if switching efavirenz to raltegravir, a     newer HIV medication, will improve vascular function and tests of bone health.   "
153792|NCT01270789|"     Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive     deterioration in the function of the pancreatic beta-cells, which are the cells that produce     and secrete insulin (the hormone primarily responsible for the handling of glucose in the     body). We propose a double-blind, randomized controlled study comparing the effect of     liraglutide (a novel anti-diabetic drug with beta-cell protective potential) versus placebo,     on the preservation of beta-cell function over one year in patients with T2DM. This study may     demonstrate an important beta-cell protective capacity of liraglutide.   "
153793|NCT01270776|"     The purpose of this study is to compare the efficacy of two different antiseptic solutions     (2%chlorhexidine in 70% alcohol with 2% aqueous chlorhexidine)when used in a standardized     controlled manner in cleansing the skin of infants with birth weight less than 1500 grams     prior to a skin breaking procedure (venepuncture).      The investigators hypothesize that the use of limited amount of 2% aqueous chlorhexidine     solution will be as effective as the same amount of 2% chlorhexidine in 70% alcohol for skin     antisepsis and that limited exposure to 2% aqueous CHG may be associated with less adverse     skin reactions.      Literature from adults has shown that both 2% chlorhexidine in 70% alcohol as well as 2%     aqueous chlorhexidine can provide effective skin antisepsis though alcohol containing     solution had more long lasting effect. It is also well known from many case reports that     alcohol containing products when used to clean abdominal skin for neonatal procedures can     cause severe skin damage in preterm infants. This has lead many neonatal units to adopt     aqueous chlorhexidine as the antiseptic agent of choice without robust evidence to support     its use or standardization of method of application.Both these solutions are widely used in     neonatal intensive care units across the globe including Canada.      By conducting this trial, the investigators want to evaluate the efficacy and safety of 2%     aqueous chlorhexidine as an antiseptic agent when used in a controlled manner [limited amount     for short duration].   "
160851|NCT00000291|"     The purpose of this study is to determine the effect of labetalol treatment on the subjective     and physiological effects of cocaine.   "
153794|NCT01270763|"     The interplay of genetic and behavioral factors is critical to understanding obesity.     Behavioral weight loss intervention has emerged as a key strategy in combating obesity.     However, individuals differ in their degree of success in these programs and genetic factors     are known to play a role. In this application, the investigators propose to identify specific     genes that predict individual differences in weight loss and high density lipoprotein     cholesterol in response to behavioral intervention to help identify individuals that struggle     with weight loss and cholesterol despite behavioral efforts.   "
153795|NCT01270750|"     Vasoconstrictive signaling via endothelin receptors is not limited to primary pulmonary     arterial hypertension, but has also been documented in secondary pulmonary hypertension due     to congestive heart failure, including cardiac valve disease. The investigators aim to     examine the clinical and physiologic effects of bosentan therapy in patients with secondary     pulmonary hypertension due to severe, inoperable cardiac valve disease, using a     single-center, prospective, open-label, non-randomized study of oral bosentan in outpatients     with severe mitral stenosis due to childhood rheumatoid fever. Primary end-point will be     exercise capacity at six months determined by six-minute walking distance and cardiopulmonary     exercise testing. Secondary end-points will be symptomatic relief, echocardiographic left     ventricular function and pulmonary pressure, serum pro-brain natriuretic peptide, and adverse     events at six months.   "
153796|NCT01270737|"     The investigators hypothesize that whole soy or purified daidzein alone could reduce blood     pressure and CVD risks in equol-producing menopausal Chinese women.   "
153797|NCT01270724|"     This study will look to see how well patients with relapsed or recurrent intracranial germ     cell tumors respond to the new combination of chemotherapy (in induction)of Gemcitabine,     Paclitaxel and Oxaliplatin (GemPOx) followed by consolidation chemotherapy and autologous     stem cell rescue.   "
153798|NCT01270711|"     The overall goal of this study will be to assess and monitor the adherence to and     effectiveness of the new prescribing guidelines for cabergoline.      Specific objectives will be to assess: 1. The indication for use of cabergoline (Parkinson,     hyperprolactinemia, other) 2. Prior treatment strategies in patients who start cabergoline     treatment for Parkinson's Disease 3. The percentage of cabergoline users who are prescribed     doses above 3 mg per day 4. Whether cabergoline users are monitored by echocardiography prior     and during treatment. 5. The incidence and prevalence of valvular fibrosis   "
153799|NCT01270698|"     This is a Phase I trial to study the safety of IMMU-130. IMMU-130 is composed of a drug     attached to an antibody. The drug is the active ingredient in irinotecan which is a common     chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by the     immune system. They bind to substances that don't belong in the body to prevent harm to the     body. The antibody in this study was designed to bind to a marker located on colorectal     cancer tumors. The antibody was originally made from mouse proteins, but was changed in the     laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts     for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is     safe.   "
153800|NCT01270685|"     The purpose of this study is to evaluate specific approaches used to prevent/reduce influenza     transmission in the SCI/D System of Care in response to the 2009 H1N1 pandemic, including     assessing infection control strategies used by SCI staff and guidance provided by local     infection control units. Due to the rapid spread of and uncertainties about the H1N1 virus,     we will evaluate patient's beliefs, behaviors, and information seeking strategies (e.g.,     social media). These findings will lend to the understanding of ways to handle emergent     issues, such as the H1N1 pandemic, in special populations.   "
153801|NCT01270672|"     The purpose of this study is to determinate the effect of a pre-treatment with carvedilol, a     alpha- and beta-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of     3,4-methylenedioxymethamphetamine (MDMA, Ecstasy). The investigators hypothesize that     carvedilol will attenuate the cardiovascular and subjective response to MDMA.   "
153802|NCT01270659|"     The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia     in comparison to standard analgesia, to determine if the FBT allows for faster achievement of     significant analgesia   "
153803|NCT01270646|"     Impact of intraventricular electrical activation in resynchronization therapy. We seek to     evaluate the impact of Cardiac Resynchronization Therapy (CRT) on electrical activation of     the Left Ventricle (LV). The first goal of the study is to evaluate if CRT is able to     decrease the heterogeneity of LV activation in heart failure patients. A second goal is to     evaluate the electrical determinant of clinical response to CRT using invasive and     non-invasive mapping technology.   "
153804|NCT01270633|"     The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix     and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with     controlled diabetes mellitus and without significantly compromised arterial circulation.   "
153805|NCT01270620|"     You are invited to participate in a research study assessing your mental status in the first     days after your surgery and how you will be doing in the 2 years following the surgery. The     investigators hope to learn more about the incidence of postoperative confusion and a     possible relation with 2 anesthesia techniques that are routinely used. The first one is an     anesthesia technique that uses the inhaled anesthetic gas desflurane and the second one is an     anesthesia technique that uses the anesthetic propofol administered by infusion in a vein.     The investigators are also looking to see if there is a relationship between anesthesia     technique and cardiovascular outcomes. You were selected as a possible participant in this     study because at your age this phenomenon appears to have a greater incidence.   "
153806|NCT01270607|"     The purpose of this study is to test the hypothesis that acupuncture will reduce Fibromyalgia     pain, via alterations in the processing of pain in the central nervous system.   "
153807|NCT01270594|"     Hypothesis: Can a counseling intervention, delivered by a pharmacist, increase inhaler     adherence in veterans with COPD who have demonstrated poor inhaler adherence through pharmacy     refill records?      Veterans who receive who receive daily maintenance inhalers from the William S Middleton     Memorial Veterans Hospital Pharmacy and who have a medication possession ratio less than 80%     over the previous six months will be invited to participate in the study. This study will     randomize 100 participants to a usual care arm or a pharmacist counseling intervention. Final     data collection will be six months after randomization to determine if both self-reported and     refill record adherence has changed.   "
153809|NCT01270568|"     This study is investigating whether a series of psychological exercises, called positive     psychology, provides benefit to patients who have been hospitalized for heart disease (an     'acute coronary syndrome' or heart failure).      In this study, subjects are randomly assigned to complete 8 positive psychology exercises     over 8 weeks, or to complete different exercises in control groups.      We hypothesize that patients who are assigned to the positive psychology tasks will be able     to complete the exercises at a high rate, will feel that the exercises were easy to perform,     and will have greater improvements of optimism, anxiety, mood, and health-related quality of     life than subjects in the control conditions.   "
153810|NCT01270555|"     The investigators propose to conduct an open study to evaluate the efficacy and tolerability     of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or     current substance use disorders. We hypothesize that Bupropion SR will be effective in     treating ADHD in this population.   "
153811|NCT01270542|"     The purpose of this study is to determine the effect of anti-VEGF drug (Avastin)     adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in     patients with Proliferative Diabetic Retinopathy (PDR).   "
153812|NCT01270529|"     Hypothesis #1: Most children with CKD stages 2-4, ESRD and kidney transplantation will report     participation in physical activity that falls short of recommended levels of physical     activity; Children on dialysis will be less active.      Hypothesis #2: Patients will endorse many barriers to physical activity, some of which will     be related to their disease or its treatment; those who are less active will endorse more     barriers.      Hypothesis #3: Patients will increase their participation in physical activity in response to     a pedometer-based 12 week intervention.      Baseline level of physical activity and magnitude of increase in physical activity will be     more closely associated with change in physical functioning and performance than stage of     kidney disease or type of renal replacement therapy.      Exercise capacity of the child will be measured by the six minute walk test whereby the     subject will asked to walk as far as possible in 6 minutes in a straight corridor.      Body fat or body composition will then be measured by Bioelectric Impedance Spectroscopy.      Physical functioning or Health Related Quality of Life will be assessed self reported/ parent     proxy reliable and validated questionnaire specifically designed for child with chronic     kidney disease called Pediatric Quality of Life Inventory (Peds QL 4.0). Subjects (teens) or     parents will also be asked to fill out a questionnaire on barriers to physical activity on     their first visit.      Physical activity will be measured in the form of daily steps. The child will wear the     pedometer for the first week to assess his/her baseline level of activity. Then the child     will continue to wear the pedometer for another 12 weeks during which time he or she will be     asked to gradually increase steps walked per day above baseline physical activity. The     patient will be called once a week in order to monitor progress, set new weekly step goals     (usually 500-1000 steps/day greater than the previous week), and motivate the participant.      After 12 weeks of the pedometer-based intervention to increase physical activity, physical     performance, body composition and physical functioning (as described above) will be measured     once again to assess the effect of increased physical activity on a second visit.   "
153833|NCT01270256|"     The purpose of this study is to see if a nasal steroid drug delivered to the nose with the     NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round     allergy symptoms).   "
157462|NCT01222923|"     The purpose of this study is to determine the pharmacokinetics and bioequivalence of     Risperidone formulations after administration of single doses to normal, healthy subjects     under fed conditions.   "
153813|NCT01270516|"     The investigators will determine if administration of HMB (hydroxymethylbutyrate) or EPA     (eicosapentaenoic acid) will increase diaphragm and limb muscle strength for patients on     breathing machines in an intensive care unit. The investigators will first measure the     strength of the diaphragm and a limb muscle (the quadriceps)using magnetic stimulators to     activate these muscles. Muscle size will be measured by using an ultrasound to measure     diaphragm thickness and quadriceps thickness. The investigators will also perform a vastus     lateralis muscle biopsy. Patients will then be randomized to receive either placebo (saline     30 ml every 12 hours via the GI tract, EPA (1000 mg given every 12 hours via the GI tract),     HMB (1500 mg given every 12 hours via the GI tract), or the combination of EPA (1000 mg given     every 12 hours via the GI tract) and HMB (1500 mg given every 12 hours via the GI tract).     Drugs will be given for 10 days; at the end of this time (on day 11), strength measurements,     ultrasound muscle size measurements, and the vastus lateralis biopsy will be repeated. On day     21 an additional followup set of diaphragm and quadriceps strength and size measurements will     be made (the biopsy will not be repeated for this last set of measurements). Patients will be     followed clinically and patient outcomes (mortality, duration of mechanical ventilation after     study entry) will be recorded.   "
153814|NCT01270503|"     This aim of the study is to assess post-marketing safety of a single dose of Menactra®     vaccine with the intent to support conversion from monitored release to initial registration     of Menactra® vaccine in the Philippines.      Primary Objective:      To describe the serious adverse events occurring within 30 days among participants who have     received one dose of Menactra® vaccine.   "
153815|NCT01270490|"     The purpose of this study is to assess the feasibility and preliminary efficacy of     interferon-gamma in combination with anidulafungin for the treatment of candidemia   "
153816|NCT01270477|"     The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant     treatment for frost damage.      The investigators hope to include at least 20 patients in a randomized manner. Half of the     patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to     have hyperbaric oxygen treatment.      Under hypotheses: The number og surgeries is reduced by hyperbaric oxygen treatment as     adjuvant treatment for frost damage. The functional level of the frost damaged patient is     better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost     damage.   "
153817|NCT01270464|"     The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or     3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than     placebo in improving lung function in patients with eosinophilic asthma as assessed by the     overall change from baseline in forced expiratory volume in 1 second (FEV1).   "
153818|NCT01270451|"     Primary Outcomes:        1. To study cross-sectional associations between diet, physical activity, T2DM and weight          in subjects 2 yrs after surgery.        2. To study if subjects receiving extra guidance in diet and physical activity experience          less weight gain compared to a control group.           Secondary Outcomes:        3. To study the association between vit.D levels and T2DM.        4. To study the association between weight change and QOL.        5. To validate the new guidance strategy by recording food intake, energy expenditure and          physical activity level.        6. To study if subjects receiving extra guidance in diet and physical activity experience          other health effects compared to a control group.        7. To search for biomarkers that can identify people at risk of increasing weight post          surgery   "
154304|NCT01264341|"     The purpose of this study is to determine whether the combination of bevacizumab/temsirolimus     is effective in patients with advanced renal carcinoma progressing after anti-VEGF treatment   "
153819|NCT01270438|"     This phase II clinical trial is studying how well giving combination chemotherapy and     bevacizumab with or without RO4929097 works in treating patients with metastatic colorectal     cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. It is not yet known whether combination chemotherapy and bevacizumab is more     effective with RO4929097 in treating patients with colorectal cancer.   "
153820|NCT01270425|"     Systemic sclerosis (SSc) is a systemic disease that involves various organs such as the skin,     kidneys, gastrointestinal tract and lungs. Dysfunction of the thyroid gland is prevalent in     these patients and may be related to thyroid fibrosis or to thyroid autoimmune disease, i.e.     hashimoto's thyroiditis. Thyroid nodules are prevalent in the general population, although     some reports suggest they might be more frequent in patients with SSc. Hashimoto's     thyroiditis, by itself, carries a higher risk for thyroid nodules and thyroid cancer.      The aim of the study:To characterize sonographycally the thyroid gland of patients with SSc     with and without Hashimoto's disease   "
153821|NCT01270412|"     Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in     osteoarthritis (OA) capsular joints via multiple mechanisms. The aim is to examine the effect     of a platelet-derived preparation rich in growth factors (PRGFs) in OA of the knee.   "
153822|NCT01270399|"     Lung cancer remains the most common cause of cancer-related death in the world. The major     advances in treatment of lung cancer have brought only minor improvements in survival     therefore novel systemic treatment methods are urgently needed.      Protein levels are regulated by the protein homeostasis network that generates and protects     the protein fold (ER and Golgi included).      The heat shock protein 90 (Hsp90) is an essential molecular chaperon involved in the     posttranslational folding and stability of proteins. Hsp90 inhibition leads to accumulation     of unfolded proteins and ER stress. The therapeutic efficacy of such inhibition may be     augmented by co-administering it with other drugs that disrupt ER-Golgi homeostasis like     histone deacetylase (HDAC) or proteasome inhibitors. ER-Golgi homeostasis disruption affects     a wide network of proteins and pathways as such affords a systemic target. Thus, the     investigators aimed to examine the effect of combined treatment of Hsp90 antagonist with     proteasome or HDAC inhibitors on human lung cancer cell lines and primary cells.   "
153901|NCT01269372|"     This pilot, multi center study will establish the effectiveness of Given PillCam® Platform     with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with     polyps, compared to standard colonoscopy.      This study will also use to evaluate the administrative feasibility and data management of     study design.   "
153823|NCT01270386|"     Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor     receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests.     Phase I study has shown that the drug's toxicity is manageable and the maximum tolerable     daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve     progression free survival compared with placebo in patients with advanced non-squamous and     non-small cell lung cancer who failed two lines of chemotherapy.   "
153824|NCT01270373|"     The purpose of this study is to evaluate the usual and the reverse sequence of an     anthracycline followed by a taxane in locally advanced breast cancer.   "
153825|NCT01270360|"     Screening campaigns for colorectal cancer (CRC) involve two steps: the detection of occult     blood in stools using a Hemoccult GAIAC test (FOBT) on three consecutive stool samples,     followed by colonoscopy if the result is positive. The information quality of the Hemoccult     test, however, is poor: in the asymptomatic 50 to 74 year-old population, the detection     sensitivity of polyps more than 1 cm in diameter is of the order of 10 to 30% and is 35 to     50% for detecting colorectal cancers; specificity is 94 to 98% that of a complete     colonoscopy. The I-FOBTs based on immunological detection and quantification of occult blood     in stools are currently being evaluated; based on the threshold it can be more sensitive than     FOBT, but enhances useless colonoscopies. Alternatively, with highest threshold of blood in     stools, it may become highly specific and miss less advanced polyps. Faecal molecular tests     based on the detection of human DNA anomalies (point gene mutations, methylation disorders of     CG islets) appear to be more sensitive than the detection of occult blood in stools with no     loss of specificity, but they are very expensive, thereby limiting their generalisation to     the scale of population screening. A formal methylated DNA test has been validated in stools     as well as in blood in a cohort of symptomatic individuals having undergone colonoscopy. The     aim of the present study is to validate this test by taking advantage of the biotechnical     expertise from renowned academic research teams and mass screening organisation.   "
153826|NCT01270347|"     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which     has been particularly problematic to eradicate and been implicated as the major cause of     morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung     increases the local concentrations of antibiotic at the site of infection resulting in     improved antimicrobial effects compared to systemic administration. Bacterial resistance to     current aerosol antibiotic treatments indicate a need for improved therapies to treat CF     patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and     other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to     have antimicrobial effects on even the most resistant organisms.   "
153827|NCT01270334|"     vaginal PH has an effect on the effectiveness of treatment with misoprostol given vaginally     for missed abortions in the first trimester   "
153839|NCT01270178|"     Persistent replication of HBV (47-55%) is frequently found in patients with HCC, which in     turn leads to deterioration of liver reserve. Moreover, a large proportion of HCC patients     who underwent curative therapy died from progressive liver decompensation rather than     recurrence of cancer. It had been proved that anti-viral therapy for hepatitis C virus     (HCV)-related HCC patients could reduce the rate of tumor recurrence after surgical     resection.      This is a prospective study to evaluate the efficacy of ETV therapy in chronic hepatitis B     patients after receiving RFA therapy for HCC.   "
153828|NCT01270321|"     The purpose of this study is to determine the effectiveness of two anticancer drugs,     everolimus and pasireotide, in patients with thyroid cancer when the cancer is no longer     responding to treatment with radioiodine or where it is deemed unsafe for the patient to     receive additional radioiodine treatment. The investigators also want to establish the best     manner of taking the two medications when used together to treat thyroid cancer. In     particular, the investigators want to know if it is better to give both at the same time or     add a second medication after the first one has stopped working.      This study will also look at specific substances called biomarkers in your blood, and in the     tumor tissue which are involved in the growth of tumor cells, and determine if the levels of     these biomarkers are related to your response to treatment or development of side effects.      Everolimus, also known by the brand name, Afinitor, is a biologic drug approved by the Food     and Drug Administration (FDA) for the treatment of kidney cancer. It works by preventing     cancer cells from multiplying and it also makes them more likely to die from the treatment.      Pasireotide also known by the name, SOM230 is a new medication that is not yet approved by     the FDA for the treatment of cancer. It is a newer form of a drug called octreotide, which is     approved for the treatment of cancer arising from endocrine organs. Pasireotide works by     binding to a protein called somatostatin receptor, which is expressed in many tissues     throughout the body including thyroid cancer cells. Pasireotide prevents the action of     somatostatin by binding to these receptors.   "
153829|NCT01270308|"     The objective of this study was to compare the relative bioavailability of Lansoprazole DR     Capsules 30 mg with Prevacid® Capsules 30 mg under fasting conditions in healthy adult human     subjects.   "
153830|NCT01270295|"     RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar     epithelial type I cell injury. Soluble RAGE (sRAGE) is elevated in the plasma and in the     pulmonary edema fluid from patients with ALI/ARDS, but one should acknowledge that the     RAGE/NF-B axis is also involved in the pathophysiology of various other conditions. Few data     are available about the levels of soluble forms and ligands of RAGE in the setting of     ALI/ARDS. The purpose of this observational prospective study is to describe soluble forms     (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in ICU patients with     ALI/ARDS.   "
153831|NCT01270282|"     The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic     AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear     tinnitus.   "
153832|NCT01270269|"     Intensive care unit (ICU) hospitalization saves lives but often does so at a high personal     cost to ICU survivors who frequently experience significant cognitive impairment and an array     of physical and functional disabilities that limit their recovery and quality of life. While     the problems experienced by these patients are likely amenable to rehabilitation, few ICU     survivors receive focused rehabilitation. Recently, early physical rehabilitation in ICU     patients has shown to improve the chances a patient will regain their pre-hospital functional     status. Early cognitive rehabilitation for these patients has not yet been explored. This     pilot study will determine the feasibility of early cognitive rehabilitation in ICU patients.     The investigators will perform cognitive and physical rehabilitation, beginning in the     earliest phases of critical illness, to determine the effect of these therapies on cognitive     and functional outcomes in ICU survivors. The investigators hypothesize that combined     cognitive and physical rehabilitation, started in the ICU, will improve recovery of cognitive     and physical function as well as improve quality of life of ICU survivors.   "
153834|NCT01270243|"     We, the investigators, propose to look at the bacteria on and in tonsils using gene     microarrays. We expect to find previously reported bacteria but also the possibility of     previously undetected organisms. We think that the bacterial pathogens present on the     tonsillar surface are different from the tonsil core. And we also think that the bacteria of     the tonsil surface will differ between patients undergoing adenotonsillectomy and normal     controls with no adenotonsillar problems.   "
153835|NCT01270230|"     African American men who have sex with men and women (AAMSMW) are at particular risk for     contracting and transmitting HIV, and represent a priority population for developing     effective interventions. Despite the urgent need for effective prevention approaches for     AAMSMW, to our knowledge no evidence-based HIV interventions have been developed and tested     for this population. This study is a randomized controlled trial of the Bruthas Project(BP),     an individual-level HIV prevention intervention, which builds on standardized HIV counseling     and testing. Delivered in a series of four sessions by trained African American male     counselors, the BP focuses on reviewing HIV transmission routes for male and female partners,     strengthening sexual communication skills with both male and female partners, and improving     condom use skills and other safer sex negotiation strategies. A randomized controlled trial     of BP is necessary to determine the efficacy of the intervention and can lead to improved     public health efforts at reducing HIV risk behavior among AAMSMW and in the African American     community more generally. To evaluate the effect of the BP, the investigators will recruit     and enroll a cohort of 400 AAMSMW who will be randomly assigned to either the intervention     condition, in which they will be offered BP, or to the comparison condition, in which they     will receive standardized HIV testing and counseling with referral to case management. The     investigators will follow the cohort over 9 months and will assess participants at three time     points: baseline, 3 months follow-up, and 6 months follow-up.   "
153836|NCT01270217|"     The purpose of this study is to determine whether brief motivational interviews reduce     problematic drinking behavior among individuals arrested for the first time for driving under     the influence of alcohol (DUI).   "
153837|NCT01270204|"     The purpose of this study is to evaluate the effect of taste on swallowing efficiency, to     evaluate the effect of temperature on swallowing efficiency, and to evaluate the effect of     viscosity on swallowing efficiency.   "
153838|NCT01270191|"     Whether GLP-1 and GLP-1 receptor agonists will produce a sustained improvement in beta-cell     function following short-term therapy is currently not known. This randomized, controlled     trial is carried to assess the efficacy of short-term insulin therapy (NPH injection twice     daily) compared with GLP-1 analogue (Exenatide injection twice daily) on glycemic control,     remission rate, ß-cell function, and long-term glycemic control in newly diagnosed type 2     diabetic patients with moderate hyperglycemia.   "
155952|NCT01242527|"     The primary objective of the study is to determine the efficacy of Epanova (omefas) compared     to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.   "
153840|NCT01270165|"     No study has reported on the comparative effect of continuing lamivudine plus adefovir versus     switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory chronic     hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The goal of     this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching     to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic     hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at least 12     months.   "
153841|NCT01270152|"     The hypothesis of the study is to evaluate whether ascorbic acid is able to clear totally     implanted central venous catheter   "
153842|NCT01270139|"     The investigators hypothesize that the nanoburning is very challenging technique to demolish     and reverse the plaque especially in combination with stem cell technologies promising     functional restoration of the vessel wall.      The completed (in July 2012) interventional three arms (n=180) first-in-man trial (the     NANOM-FIM trial) assessed (NCT01270139) the safety and feasibility of two delivery techniques     for nanoparticles (NP), and plasmonic photothermal therapy (PPTT) of atherosclerotic lesions.     Patients were assigned in a 1:1:1 ratio to receive either (1) nano-intervention with delivery     of silica-gold NP in mini-surgery implanted bioengineered on-artery patch (n=60), or (2)     nano-intervention with delivery of silica-gold iron-bearing NP with targeted micro-bubbles or     stem cells in hands of magnetic navigation system (n=60) versus (3) stent implantation     (n=60). The primary outcome was TAV at 12 months.      The observational prospective cohort analysis (an amendment to the protocol of August 29th     2012 with a decision to extend a 1-year study for another 4 years with the assessment of the     5-year clinical outcomes both retro- and prospectively) of the long-term clinical outcomes at     the intention-to-treat population of 180 patients with CAD and angiographic SYNTAX score ≤22     enrolled initially to NANOM-FIM trial will be performed at 5 years after the intervention.     The primary outcome will be a MACE-free survival. The secondary outcomes will be MACE,     cardiac death, TLR (target lesion revascularization) and TVR (target vessel     revascularization). Imaging endpoints will be assessed pre-, post- procedure and at 12-month     follow-up. Clinical endpoints will be analyzed at the baseline and at 12 and 60-month     follow-up (the release of results is expected after October 2016). Parameters of nanotoxicity     will be assessed.      The subset post-hoc analysis will be conducted at 1- and 5-year follow-up (by the Amendment     of August 29th 2012). At the first subset patients underwent stenting with XIENCE V stent     proximal to the site of nano-intervention (n=13). Subjects in the second subset were     undergone drug-coated balloon pre-dilation with further nano-technique (n=20). Lesions in     patients of the third subset were not prepared for the nano-approach (n=147) (neither     stenting nor balloon angioplasty). The analysis will be performed and results will be     released in 2017 with the same clinical outcomes.      This project and related manuscripts were not prepared or funded in any part by a commercial     organization. Nanoparticles and biomedical equipment were supplied free for the study by the     non-profit Agiko and De Haar Foundation (Rotterdam, the Netherlands). All rights of the     authors are reserved. The access of the international academic or governmental organizations     to the essential and primary data of the trial is restricted by the Russian governmental     authorities due to interest of the Russian Federal Security Service (FSB).   "
153843|NCT01270126|"     Non-invasive brain stimulation can increase cortical excitability in the visual system, but     it is not known if this is of clinical value. The investigators now assessed if repetitive,     transcranial alternating current stimulation (rtACS) can improve visual field size in     patients with optic nerve damage. The investigators hypothesized that rtACS would improve     visual functions within the defective visual field sectors of the visual field (primary     outcome measure).   "
153844|NCT01270113|"     China faces the challenge of dual epidemics of drug use and HIV/AIDS. In responding to     concerns of high rates of HIV/AIDS and other medical consequences among heroin users, China     has recently implemented methadone maintenance treatment (MMT) programs nationwide. One     problem noted with this rapid expansion is that the dropout rates from MMT have been high.     The proposed study will adapt a motivational incentives (MI) intervention developed in the     United States for use in Chinese MMT settings and will pilot test its effectiveness in     improving treatment compliance and outcomes. The study's primary aims are: 1. to adapt a     motivational incentives intervention in MMT in China, and 2. to experimentally pilot test the     motivational incentives intervention. A secondary aim is to explore factors that may     influence the outcomes of MMT that incorporates a motivational incentives intervention. It is     hypothesized that the MI intervention can be adapted to Chinese settings and that it will     optimize the positive outcomes of MMT in reducing HIV risks among heroin abusers. The     collaborative team includes researchers in American and Chinese institutes (UCLA/Johns     Hopkins/Washington, Shanghai Mental Health Center, Yunnan Institute for Drug Abuse),     officials from national and local Chinese Centers for Disease Control and Prevention, and     providers in local MMT clinics in Shanghai and Yunnan.   "
153856|NCT01269957|"     Objective: determine whether there is a correlation between halitosis and mouth breathing in     children. Study design: Fifty-five children between three and 14 years of age were divided     into two groups (nasal and mouth breathing) for the assessment of halitosis. Descriptive     analysis was carried out regarding the degree of halitosis in each group. The chi-square test     was used for the comparison between groups, with 5% level of significance.   "
153916|NCT01269177|"     The purpose of this study is to define the current treatment of patients ospitalized with     acute cardiogenic pulmonary edema. Clinical and laboratory data collected in the Emergency     Department will used to investigate the primary outcome (mortality) and risk factors related     to the primary outcome.   "
153845|NCT01270100|"     The purpose of the study is to develop and pilot-test a Recovery Management Intervention     (RMI) program for heroin addicts released from compulsory rehabilitation in China.      The project has the following specific aims:      Primary aims:      Aim 1. To engage key stakeholders in the local communities involved in supporting the     transition of heroin addicts released from compulsory rehabilitation to the community; Aim 2.     To identify potential barriers for participating in MMT in China; Aim 3. To develop and     deliver educational/training materials on HIV risks, relapse prevention, and MMT; Aim 4. To     adapt and develop the Recovery Management Intervention (RMI) program for heroin addicts     released from compulsory rehabilitation in China; Aim 5. To conduct a pilot trial and obtain     preliminary outcome data associated with RMI, relative to enhanced standard care.      Secondary aim:      Aim 6. To explore predictors of relapse and HIV/AIDS risk behaviors.      It is hypothesized that the intervention will reduce drug use relapse and the negative     consequences associated with relapse, including HIV risk behaviors   "
153846|NCT01270087|"     The purpose of this study is to determine whether anti-inflammatory treatment with adalimumab     (Humira) reduces endothelial activation in blood vessels in patients with active rheumatoid     arthritis. Markers of endothelial activation are assessed in muscle tissue before treatment     and after 3 months, and related to other biomarkers and clinical outcomes.   "
153847|NCT01270074|"     The general aim of this project is to conduct a randomized, double-blind, placebo-controlled     clinical trial of azithromycin to determine whether treatment from infancy is safe and will     prevent the onset of bronchiectasis. One hundred and thirty infants will be recruited from CF     clinics in Australia and New Zealand and treated from 3 months to three years of age. The     primary outcome will be the proportion with radiologically-defined bronchiectasis at 3 years     of age. Safety and mechanistic evaluations will also be undertaken.   "
153848|NCT01270061|"     Project Wellness is a new intervention that combines the use of culturally-sensitive,     video-based education, a general health screening approach, and a community pharmacy setting     into one program to improve black African immigrant participation in voluntary HIV testing.     The study is divided into three phases: qualitative research; video production; and a     feasibility trial. In Phase 1, the investigators will conduct in-depth interviews and focus     group discussions with black African participants to obtain insights on overlapping and     resonating themes that will help increase participation in HIV testing among black Africans     in the Bronx. In Phase 2, data obtained through qualitative work will guide the development     of four health education videos. A culturally-tailored educational video on diabetes,     hypertension, and HIV will be developed and produced for each gender and in both English and     French. In phase 3, the investigators will test the feasibility of a pharmacy-based,     culturally-tailored, general health screen that includes rapid HIV testing. The trial will     help determine the feasibility of using a computer-based model; recruitment of black Africans     in the pharmacies; acceptance of testing; and linking individuals diagnosed with health     problems into medical care. A secondary analysis will also determine predictors of refusing     to be tested.   "
153849|NCT01270048|"     The purpose of this research is to examine the effect of Bunsimgi-eum on the chest discomfort     of Hwa-byung's major symptom and develope and establish pattern identification system in     Hwa-byung.   "
153850|NCT01270035|"     In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg     every other week when used in combination with methotrexate (MTX) for patients with     rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients,     especially for those with high disease activity. Therefore, we tried to increase the ADA dose     to 80 mg every other week with concomitant MTX, only if the disease activity did not decrease     below moderate activity defined by DAS28 < 3.2. The primary endpoint was the rate of patients     who achieved disease remission (DAS28 < 2.6) at 30 weeks with this predifined treatment     strategy.   "
153851|NCT01270022|"     The aim of this study is to evaluate the impact of a clinical guideline in cardiovascular     risk, with a local adaptation model of the existing guidelines in clinical practise at     present, of each of the different cardiovascular risk factors, and the implementation     strategy.   "
153852|NCT01270009|"     MM accounts for 10% of hematopoietic malignancies. Despite the use of various drug     combinations in chemotherapy, life expectancy of MM patients does not exceed 7 years. Until     now, lack of specific markers of the disease has not allowed efficient specific molecular     targeting. In view of our preliminary results, the antiapoptotic protein Bcl-B could be a     novel diagnostic and pronostic marker of MM. Therefore, our main objective will be to confirm     that Bcl-B is indeed a novel diagnostic and pronostic marker and a new potential therapeutic     target of MM. Targeting Bcl-2 family member's is a promising strategy for the treatment of     hematopoietic malignancies. In this context, specific targeting of Bcl-B could improve the     treatment of patients suffering MM. Of note, this could be achieved by converting the     antiapoptotic function of Bcl-B to a proapoptotic one thanks to the use of small mimetic     peptides derived from Nur77 one of its interactors.   "
153853|NCT01269996|"     To evaluate the efficacy and safety of a new treatment regimen of metformin plus sitagliptin     (Janumet) followed by a long-acting basal insulin (Lantus) treatment compared to the usual     treatment regimen of metformin followed by sulfonylurea and intermediate-acting basal insulin     in Type 2 Diabetes Mellitus patients.   "
153854|NCT01269983|"     The purpose is to evaluate the effectiveness of a physiotherapy program for chronic low back     pain. We'll randomize more about 35 patients in two groups. Both groups will receive an 8     physioterapy intervention in 4 weeks, in particular the first group (study) will receive 4     Fascial Manipulation treatment combined with 4 session of a standard approach (mobilization     and stretching exercises); whereas the second (control) will receive only the standard     approach.   "
153855|NCT01269970|"     Early metabolic response evaluation may predict clinical and histopathological response after     neoadjuvant chemotherapy. Its value in neoadjuvant chemoradiotherapy (CRT) is unknown. Our     aim was to assess the value of early metabolic response after one cycle of chemotherapy using     18-FDG-PET-CT to predict pathological response and outcome in cT2-4 N0/+ esophageal cancer     treated by neoadjuvant CRT and esophagectomy.   "
153866|NCT01269827|"     The aim of this study was to compare the effect of PTX vs placebo on serum concentrations of     TNF-α, IL-6, and CRP in patients on hemodialysis.   "
168824|NCT00047437|"     The purpose of this study is to determine the long-term safety and effectiveness of exercise     training for individuals with congestive heart failure (CHF).   "
153857|NCT01269944|"     Medial compartment osteoarthritis of the knee is commonly treated by a surgical intervention     called 'high tibial osteotomy' (VTO). Although it has repeatedly been shown that pain     improves following this procedure, it is unknown how cartilage quality is affected by the     procedure. In this study, a recently developed MRI technique is used to evaluate changes in     cartilage quality before and after the surgery. Changes in MRI signals are correlated to     subjective improvements (score lists). 10 patients participate in this study. Approval has     been granted by the Medical Ethical Committee of the University Medical Center Utrecht. All     participants are required to give informed consent before participation.   "
153858|NCT01269931|"     Bronchoscopy is a procedure whereby a small flexible camera is used to inspect and biopsy     abnormalities in the lungs. Linear endobronchial ultrasound with transbronchial needle     aspiration (EBUS-TBNA) is a revolutionary diagnostic pulmonary procedure that allows     visualization and safe, accurate biopsies of structures in and around the lungs during     bronchoscopy. EBUS-TBNA can be challenging to learn.      Historically, bronchoscopy has been taught using an apprenticeship model, whereby trainees     practice on patients. With the introduction of computer bronchoscopy simulators, trainees can     now obtain basic bronchoscopy skills by practicing on the simulator, rather than practicing     on patients.      This study aims to compare trainee EBUS-TBNA performance during actual procedures on     patients, following training with a computer EBUS-TBNA simulator versus conventional clinical     EBUS-TBNA training (trainees taught by practicing on patients). Our hypothesis is that the     skills learned using a computer EBUS-TBNA simulator are transferable to clinical EBUS-TBNA     performance, meaning that using a computer EBUS-TBNA simulator for training is just as good     as learning these skills by practicing on patients.      The use of EBUS-TBNA simulators for training could have the advantage of minimizing the     burden of procedural learning on patients.   "
153859|NCT01269918|"     This will be a randomized blinded clinical trial. Patients will be randomized to receive     either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia team     will know the result of randomization at induction. Data will be gathered by research     personnel who will be blinded to the anesthetic method used. Patients will be blinded to the     anesthetic they receive till they are discharged from the PACU when they will have the option     to be unblinded. The Data Safety and -Toxicity Committee will review all serious adverse     events and toxicity reports as well as annual reviews.   "
153860|NCT01269905|"     The optimal valve substitute for patients between 60-70 years is controversial. We compared     anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve     replacement (MHVR) on INR self-management vs. stentless bioprosthesis, to assess whether the     risk of structural valve deterioration (SVD) is still out-weighted by the benefit of not     requiring permanent anticoagulation.   "
153861|NCT01269892|"     The purpose of this study is to determine which nutritional regime is better for acute     diarrhea in outcomes.   "
153883|NCT01269606|"     This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at     which rate the body eliminates the substance from the body) of insulin aspart with     fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection     in Japanese subjects with type 1 diabetes mellitus.   "
153862|NCT01269879|"     A number of different therapeutic approaches to treat lateral epicondylitis have been tested     partly in randomized trials, such as polidocanol sclerosing injections, botulinom toxin A     injections, braces, surgery and topical NO patches.      One study indicates that patients with lateral epicondylitis (lateral elbow tendinopathy)     have poorer elbow proprioception in contrast to healthy controls (Juul-Kristensen B, et al.,     J Shoulder Elbow Surg 2008;17(1 Suppl):72S-81S.)      Based on a suggested poorer elbow proprioception in lateral elbow tendinopathy, The     investigators hypothesize that a dedicated proprioceptive intervention might be able to     reduce pain and improve function.      As such a RCT is planned with two intervention arms with proprioceptive training using the     Flexi-Bar vibration device (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk)     over twelve weeks.   "
153863|NCT01269866|"     The purpose of this study is to determine whether Duloxetine (cymbalta) can reduce pain     severity in patient with Systemic Lupus Erythematosus.   "
153864|NCT01269853|"     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of     tumors also exhibits the most aggressive behavior, resulting in median overall survival     durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of     either surgical resection, external beam radiation or both. All patients experience a     recurrence after first-line therapy, so improvements in both first-line and salvage therapy     are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently     used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators     have shown in a previous phase I trial that a single Super-selective Intraarterial Cerebral     Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of     recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that     trial in that the investigators seek to test the hypothesis that repeated dosing of     intraarterial Bevacizumab is safe and effective in the treatment of recurrent malignant     glioma. By achieving the aims of this study the investigators will also determine if IV     therapy with Bevacizumab should be combined with repeated selected intraarterial Bevacizumab     to improve progression free and overall survival. The investigators expect that this project     will provide important information regarding the utility of repeated SIACI Bevacizumab     therapy for malignant glioma, and may alter the way these drugs are delivered to the patients     in the near future.   "
153865|NCT01269840|"     In severe injuries of the radial head with multiple, displaced fracture fragments and     concomitant ligament damage, excision of the fragments and replacement of the radial head     with a metallic implant are indicated. Current radial head implants are composed of metal or     a combination of metal and high molecular weight polyethylene. The prostheses are assembled     intra-operatively as a solid unit (monopolar) or as an articulating implant with motion     between the stem and head (bi-polar). The stem of the implant is inserted into the proximal     radius for support and can be classified as either loose-fitting or fixed. According to the     investigators, there are no studies that directly compare the clinical and radiographic     outcomes between different radial head implant designs. The purpose of this retrospective     study is to compare the clinical and radiographic results in patients treated for an     irreparable radial head fracture with either a smooth stem, bipolar radial head implant or a     monopolar, in-growth radial head implant. The study findings may provide useful clinical     information regarding the similarities and differences in these two implant designs.   "
153878|NCT01269671|"     IND application was submitted to FDA on November 17th.   "
153867|NCT01269814|"     The patients who admit to emergency department with upper gastrointestinal system bleeding     will undergo a clinical evaluation with Rockall Risk Scoring System. The patients with     Rockall score of 1 or less will be discharged with medical treatment, and will have an     elective upper gastrointestinal endoscopy in the end of the 30th day. The impact of Rockall     Risk Scoring System on assessing the necessity of emergency endoscopy, length of hospital     stay, morbidity, and mortality in low-risk patients will be evaluated.   "
153868|NCT01269801|"     The purpose of this study is to see how well Juvederm Ultra XC or Juvederm Ultra Plus XC, and     BOTOX Cosmetic, work compared to each other and when used together for the cosmetic treatment     of age-associated wrinkles and folds of the face.   "
153869|NCT01269788|"     Gastro-esophageal reflux disease (GERD) is highly prevalent, affecting up to 20% of the adult     population in North America. Up to 70% of GERD patients have non-erosive reflux disease     (NERD), a term used to describe symptoms suggestive of GERD in patients with no endoscopic     evidence of erosive esophagitis. NERD represents a heterogeneous group of patients whom are     sub classified according to 24 hours-PH monitoring results and also symptom-acid association     analysis(Symptom Index,SI).      Treatment of NERD can be a challenge for clinicians. According to the many studies , the     pooled rate for symptomatic response after a period of proton pomp inhibitor(PPIs)therapy as     the most frequently used drug, in NERD patients is lower than for erosive esophagitis     patients. It is also shown that acid exposure is much lower in NERD patients than those with     erosive esophagitis and NERD patients are less likely to exhibit a strong association between     heartburn symptoms and acid reflux events than patients with erosive oesophagitis.      Furthermore, beside the high economic burden, there are concerns about the adverse effects of     long time administration of PPIs.      Several hypothesis has been proposed to describe low response rate of NERD patients to PPIs.     One of the most acceptable theories is that patients with anxiety or depression and     psychological problems are at an increased risk of developing reflux symptoms. On the other     hand, pain modulators such as sertraline, a selective serotonin reuptake inhibitor(SSRI), and     other antidepressants have been shown to improve symptoms in patients with functional     gastrointestinal disorders like non cardiac chest pain.      According to the above-mentioned tips, the investigators hypothesize that antidepressants     like fluoxetine, as an SSRI, may have beneficial effects in improving symptoms of NERD     patients.      The purpose of this study is to compare the effect of omeprazole with fluoxetine and placebo     for treatment of NERD patients and its subgroups who all experience reflux symptoms and have     normal endoscopic findings.   "
153870|NCT01269775|"     The investigators carried out a randomized controlled trial comparing three methods of     teaching. These three instructional methods consist of face to face lecture, interactive     internet based teaching and computer based teaching (lecture synchronized with presentation).      The hypotheses tested were: a) whether there is a difference between these three methods in     knowledge achievement and b) whether there is a difference between Students satisfaction in     three groups.   "
153882|NCT01269619|"     Lower back pain is one of the most common conditions affecting humans. Lower back supports     are a common device used in order to alleviate the pain. All the available back supports are     wrapped around the lower back and abdomen and act as static support devices. The hug is a     new dynamic back support where the participant actively improves his/her posture and     strengthens the muscle of the lower back. This trial compares both devices and their effect     on reducing lower back pain.   "
153871|NCT01269762|"     Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a     significant cholesterol lowering effect which might be caused by addictive and/or synergistic     effects of lovastatin (monacolin K) with other monacolins and substances in capsules. The     usual dose of red yeast rice capsule(LipoCol Forte)for hypercholesterolemia is one capsule     twice/day.      However, the pharmacokinetic profile of red yeast rice capsule (LipoCol Forte)is still     unknown.      The objective of the study is to evaluate the pharmacokinetic profile of red yeast rice     capsule (LipoCol Forte) after administering single and multiple dose to healthy subjects.   "
153872|NCT01269749|"     The investigators hypothesize that 131I is an effective therapy for children with Graves'     Disease (GD) and will not be associated with long-term cancer risks when used in older     children, but may be associated with excessive levels of whole body radiation in young     children. To address issues of 131I safety and cancer risk in the pediatric population, the     investigators propose to: (1) Perform dosimetry to assess whole body radiation exposure     following 131I therapy in children treated for GD (2) the investigators will assess     chromosome translocation as related to age and dose of 131I.      It is anticipated that these studies will provide new insights into RIA use in children and     provide important information about radiation exposure associated 131I use in children. As     such, these studies are expected to result in new recommendations for 131I use in the     treatment of pediatric GD.      Funding Source - FDA OOPD   "
153873|NCT01269736|"     The purpose of this study is to test the effect of implementing new practice standards for     electrocardiographic (ECG) monitoring on nurses' knowledge and skills, quality of care, and     patient outcomes. The investigators hypothesize that increased knowledge and skills of nurses     will lead to enhanced quality of care, which will result in improved outcomes for patients.   "
153874|NCT01269723|"     Vegetables such as broccoli, cauliflower, kale and cabbage are particularly rich in a plant     chemical called sulforaphane (SFN) which boosts production of certain defense enzymes that     increase the activity of antioxidants. In animals, the chemical protection from SFN helps     prevent diseases associated with inflammation and cancer among others, and this is currently     being studied in humans.      Young broccoli sprouts have a particularly high level of SFN compared to other foods. The     purpose of this research study is to learn about short term responses to live attenuated     influenza virus (LAIV, administered to you via Flumist® vaccine) between smoking and     nonsmoking volunteers treated with broccoli sprout homogenates (shake) or a placebo     homogenate. This will be done by obtaining a series of nasal lavages or rinses of your nose     with salt water, as well as 3 superficial biopsies of the inside lining of your nose both     before and after you receive the vaccine. Using these samples, we will measure the amount of     virus and the amount of inflammation in your nose and compare how smokers and nonsmokers     respond to the vaccine when they are given a broccoli sprout homogenate (high in SFN) or a     placebo alfalfa spout shake which is low in SFN during each of 4 study visits.      Subjects will be seen for a screening visit (inc. HIV test) and then randomly assigned to     receive 1 of 2 homogenates. Broccoli sprout homogenate will be the the active treatment arm     while the placebo arm will be alfalfa sprout homogenate. Two to 4 weeks after screening,     subjects will return for 5 sequential visits (Monday-Friday). Monday-Thursday they will     receive the assigned homogenate. On Tuesday, they will receive the Flumist®vaccine. Subjects     will also be seen at 1 and 3 weeks post vaccine. Nasal lavage (NL), blood samples and nasal     biopsies will performed prior to and after study interventions.   "
153875|NCT01269710|"     The purpose of this study is to get a better understanding of the side effect burden and     identify predictors of psychotic, mood and aggressive disorders in children and adolescents.     The study's primary aim is to identify genetic risk factors for weight gain and metabolic     abnormalities.   "
153876|NCT01269697|"     Age-related macular degeneration (AMD) is a degenerative disease of the centre of the retina     (named macula) and is the leading cause of blindness in industrialized countries. There is     growing interest in the potential preventive role of two carotenoids (lutein and zeaxanthin)     of dietary origin, which specifically accumulate in the macula, where they form the macular     pigment. A first step towards the demonstration of a preventive effect of macular pigment for     AMD consists in the evaluation of the effect of lutein and zeaxanthin supplementation on     their plasma and retinal concentrations.   "
153877|NCT01269684|"     The purpose of this study is to investigate safety and tolerability of an immediate     conversion from Tacrolimus to everolimus in stable renal allograft recipients.      Interest in developing CNI-free regimens using other agents such as the proliferation signal     inhibitor everolimus.   "
153880|NCT01269645|"     The primary objective of this project is to examine the impact of providing cancer patients     with audiovisual information about clinical trials on attitudes towards clinical trial     participation. It is hypothesized that patients provided these materials will have more     favorable attitudes toward clinical trial participation compared to patients not provided     these materials.      Participants will be randomized to either: (1) an intervention condition in which they will     be asked to view a short video and read an accompanying brochure about clinical trials     developed by the investigative team; or (2) a control condition in which they will be asked     to read the National Cancer Institute's brochure entitled Taking Part in Cancer Treatment     Research Studies. Self-report data will be collected at two timepoints: 1) in person     following study enrollment, but before receipt of material related to intervention assignment     (baseline/Time 1), and 2) by telephone interview between 7 and 28 days following study     enrollment (follow-up/Time 2). In addition, data will also be collected from medical records     six weeks after study enrollment.   "
153881|NCT01269632|"     Background: With the improvement of the prognosis for HIV-infected infants, thanks to the     availability of antiretroviral therapies, young adults infected with HIV since birth are     becoming an emerging group among the HIV-infected population. Morbidity, mortality and     immunovirological evolution in these young adults need to be studied in a large population     and compared to patients infected with HIV later in adulthood or to the general population in     terms of mortality. Moreover, the study of accelerated or premature ageing, linked to HIV     and/or antiretroviral therapy, is particularly interesting in this population.      Objectives: To study the transition to adulthood and the further evolution of HIV-1 or -2     perinatally infected young adults: 1) To study the teenager to adult transition in terms of     clinical and immunovirological status, schooling and professional integration, sexuality and     reproductive life, transition from paediatrics to adult departments; 2) To study prognosis,     morbidity and mortality according to age, infection stage at the time of antiretroviral     initiation and therapeutic history; 3) To study the incidence and expression of adverse     events and the potential link to antiretroviral therapies; 4) To study the markers of a     potential premature ageing, from the metabolic, cardiovascular and immunological points of     view.   "
154883|NCT01257113|"     The purpose of this study is to determine whether there are any difference between supervised     exercise therapy and homebased exercise when looking at pain and function for patients with     shoulder pain.   "
153884|NCT01269593|"     The purpose of this study is to see how a new drug, named PUH71, accumulates in the different     parts of the body & inside tumors and how long PUH71 lasts in the blood, when given to study     participants in tiny amounts. The results of this study will help researchers (1) plan how     they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of     cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting     tumors with scanner machines.   "
153885|NCT01269580|"     Type of Study: Pilot Study monocenter Study Duration: 18 months Subject Participation     Duration: The patients are enrolled for the time of the blood withdrawl.      Follow up visit will be after 12 months from the enrollement.      Objectives:      The project will have two major objectives:      A)To validate the prognostic value of vascular progenitor cells, identified by flow     cytometric analysis of antigenic phenotype, in a cohort of 109 patients with type-2 diabetes     complicated by ischemic foot ulcers. Events are: cardiovascular mortality, major amputation,     post-angioplasty restenosis , and development of new atherosclerotic plaques in treated limb     B)To determine the mechanisms responsible for vascular progenitor cell dysfunction in the     perspective of new therapies for the cure of the diabetic foot.   "
153886|NCT01269567|"     After rectal excision, the rate of anastomotic leak and abscess is higher than after colic     surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a     prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness     of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice     had never been evaluated in patients with rectal excision and low anastomosis (patients with     a high risk of pelvic sepsis)   "
153887|NCT01269554|"     Diarrhoea is the leading cause of death in the world with 2.2 million deaths every year. The     majority of deaths are among children in developing countries, but the travellers encounter     the disease as well. The studies on the aetiology have suffered from serious methodological     deficiencies and the results are even controversial. At the same time, the current diagnostic     methods are inadequate. The investigators have recently developed novel multiplex RT-PCR     methods to cover the majority of diarrhoeal pathogens. The present study is a collaboration     between Finland and Sweden/Guinea-Bissau. The aim is to characterize the causative agents of     diarrhoea (a) in Finnish volunteers before and after a travel to tropical areas and, (b) in     inhabitants of endemic areas in Guinea-Bissau. For these purposes stool samples will be     collected from volunteers of different age groups and from healthy volunteers as well as     those with diarrhea both in Guinea-Bissau and in Finland. In addition to pathogens, other     intestinal microbes and antimicrobial resistance will be investigated   "
153888|NCT01269541|"     The purpose of this study is to determine whether systemic antibiotic treatment with     rifampicin and clindamycine or trimethoprim-sulfa in addition to topical treatment with     mupirocin is more effective than only topical treatment to eradicate MRSA in throatcarriers   "
153917|NCT01269164|"     The purpose of this study is to apply human facial allograft transplant to the subjects with     severe facial deformities or disfigurements in order to provide adequate coverage, aesthetic     appearance and functional outcome.   "
154057|NCT01267331|"     This prospective, randomized, placebo-controlled study was designed to assess the safety,     feasibility and efficacy of intramyocardial injection of autologous bone marrow mononuclear     cells in patients with severe, chronic ischemic disease scheduled to coronary artery bypass     surgery.   "
154058|NCT01267318|"     Development of a new diagnostic detection tool for gastrointestinal bleeding.   "
153889|NCT01269528|"     Protocol Synopsis: There is a link between early RSV infection and chronic respiratory     morbidity.      Hypothesis: Palivizumab administration may result in decreased AHR and lower respiratory     morbidity.      Primary objective: to evaluate prospectively the effect of palivizumab on airway reactivity     (AHR) in children born at 29-32 weeks.      Secondary objective: to assess prospectively the effect of palivizumab on respiratory     morbidity airway inflammation and allergy in children born at 29-32 weeks.      Inclusion criteria: premature babies 29-32 weeks of gestation born during 2007 and 2010.      Exclusion criteria: Any mechanical ventilation or chronic diseases, e.g., bronchopulmonary     dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies, known     immunodeficiency, or receipt of other RSV investigative vaccines or therapies.      Primary end points: Airway reactivity as assessed by methacholine challenge test with     determination of PC20.      Secondary end points: Respiratory morbidity as assessed by questionnaire and telephone     interviews. Additionally, IGE, eosinophil count, and exhaled NO will be evaluated.      Sample size: 74 participants; Group I - 37 premature babies at 29-32 weeks of gestation born     during 2007-2008 (before approval of Synagis for this group in Israel). Group II - 37     premature babies 29-32 weeks of gestation born during 2009-2010 (after approval of Synagis     for this group in Israel).      Statistics: A sample size of 37 patients was calculated as necessary to detect a difference     of 0.5 SD in AHR for a 2-sided tail, with a power of 80%. Demographics and baseline     characteristics will be compared using 1-way analysis of variance for quantitative variables     and Fisher's exact test for categorical variables.   "
153890|NCT01269515|"     Chronic immune activation is a central feature of HIV-infection, and the degree of activated     T-cells is a better predictor of disease progression and mortality than plasma viral load.     The study hypothesis is that the anti-inflammatory substance etoricoxib will dampen chronic     immune activation and improve the effect of T-cell dependent vaccines in HIV-1 infected     patients.      The aim of the present study is to explore the efficacy of the study drug on markers of     immune activation and vaccine responses, as well as safety of the study drug, in HIV-infected     patients not receiving antiretroviral therapy and in patients on long-term effective ART who     had CD4 counts < 500.   "
153891|NCT01269502|"     A randomised controlled pilot study on the feasibility of introducing a skin temperature     device (Temp Touch) in secondary prevention of foot ulcers in people with diabetes who have     had a foot ulcer in Norway.   "
153892|NCT01269489|"     The purpose of the study is to obtain reference data on health-related quality of life for     the functional and symptom scales and single items of the European Organisation for Research     and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ C30) in a     representative sample of Slovenian general population.   "
153934|NCT01268943|"     The purpose of this study is to seek the proper dose of capecitabine in post-operative     concurrent chemotherapy for stage II/III elderly rectal cancer patients receiving radical     surgery, and evaluate the toleration of this modality in such patients.   "
153893|NCT01269476|"     This is a randomised, double-blind, group-sequential, placebo-controlled, safety and     pharmacokinetic study in healthy, aged volunteers.      Objectives:        1. to confirm the previously reported safety profile of oral SNX-001 after single and          multiple doses of 3.6, 7.2 or 10.8 mg compared to placebo        2. to establish SNX-001 pharmacokinetic profile.   "
153894|NCT01269463|"     The time course of response following one dose of a new methylphenidate hydrochloride     extended release capsule is studied in children 6-12 years in a simulated laboratory     classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been     formulated for daily dosing to provide treatment of a child with ADHD for the substantial     day.   "
153895|NCT01269450|"     Working hypothesis and aims:      To investigate whether progesterone treatment affects the incidence of preterm labor compared     to placebo, among women with 2nd trimester bleeding.      The participants will be allocated through randomization to a study or control group. Women     in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an     intra-vaginal tablet once daily while the control group will receive placebo. Both women and     medical staff will be blinded to group allocation. Treatment will commence on the day of     inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation.     Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal     outcome.   "
153896|NCT01269437|"     This is an open-label, randomized, parallel Group, multicenter study to evaluate the efficacy     and safety of budesonide novolizer dry powder inhaler compared with budesonide turbuhaler dry     powder inhaler in Chinese mild to moderate asthma patients.   "
153897|NCT01269424|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     O6-benzylguanine may help temozolomide work better by making tumor cells more sensitive to     the drug. Giving genetically modified peripheral blood stem cells during or after treatment     may prevent side effects caused by chemotherapy.      PURPOSE: This clinical trial studies O6-benzylguanine and temozolomide in combination with     genetically modified peripheral blood stem cells in treating patients with newly diagnosed     glioblastoma multiforme.   "
153898|NCT01269411|"     This phase I trial is studying the side effects and best dose of RO4929097 in treating     patients with recurrent invasive gliomas. RO4929097 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth   "
153899|NCT01269398|"     Utilization of trans-pedicular trans-discal implants for stabilization of a single lumbar     motion segment, in conjunction with posterior facets fusion. The trajectories are planned and     achieved by means of the SpineAssist® system - a computerized, image-based guidance system     that assists surgeons in precisely guiding spinal surgical tools and implants in line with a     CT-based pre-operative plan. GO-LIF and SpineAssist are CE marked products.      Thy study's objective is to to collect data regarding the ability to achieve solide fusion,     comibing the GO-LIF procedure for spinal fixation and stabilization with percutaneous     posterior facets fusion.   "
153900|NCT01269385|"     RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can kill chronic     lymphocytic leukemia (CLL) cells and are effective therapies for this disease. Biological     therapies, such as Imprime PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose), may     stimulate the immune system in different ways and help monoclonal antibodies kill CLL cells.     Giving PGG beta-glucan together with alemtuzumab and rituximab could make therapy with     monoclonal antibodies, such as alemtuzumab and rituximab, more effective.      PURPOSE: This phase I/II trial is studying the side effects and best dose of PGG beta-glucan     when given together with alemtuzumab and rituximab and to see how well it works in treating     patients with earlier stage high-risk chronic lymphocytic leukemia.   "
153902|NCT01269359|"     Modern orthopedic and spine surgeons strive towards minimizing surgical exposure and towards     increased precision in the placement of implants. This trend requires an increased use of     fluoroscopic guidance, which leads to increased exposure of the patient, surgeon and the     operating room staff to radiation.      Robotic assisted spine surgery is routinely performed in the authors' institution for a     variety of indications such as degenerative conditions, trauma, tumors , infections and     deformity correction11. The objective of this study is to compare the radiation exposure time     during robotic guided vertebral body augmentation to the published results for similar     surgeries.   "
153903|NCT01269346|"     This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin     mesylate in combination with trastuzumab as first line treatment in female subjects with     locally recurrent or metastatic human epidermal growth factor receptor (HER2) positive breast     cancer.   "
153904|NCT01269333|"     Clopidogrel is a platelets inhibitor that is widely used particularly during and after acute     coronary events and coronary interventions. Several studies have shown that some patients are     resistant to clopidogrel. The resistance mechanism is not entirely clear yet, but at least in     part it is related to interactions between medications.      Omeprazole is a member in the family of gastric proton pump inhibitor (PPI) that are widely     used in patients who receive combination of aspirin and clopidogrel in order to protect the     stomach lining and prevent GI bleeding. Data from studies on platelet aggregation indicate     that treatment with omeprazole may cause partial resistance to clopidogrel and increase risk     for recurrent cardiovascular events in patients after coronary interventions. Recently the     FDA published struck to avoid cross clopidogrel and omeprazole treatment for fear of     reduction efficiency. Nevertheless there are several studies that do not support increased     risk of cardiovascular events among patients taking omeprazole and clopidogrel, as the COGENT     trial which is the single prospective controlled study that assessed the clinical implication     of this drugs interaction.      The accepted Mechanism of interaction between omeprazole and clopidogrel is disturbance to     create clopidogrel active metabolite through CYP2C19 inhibition by omeprazole. fluvoxamine -     is a member in SSRIs family and a potent inhibitor of the CYP2C19. In vivo studies compared     the degree of decomposition proguanil (a CYP2C19 indicator) by fluvoxamine and omeprazole     found constant inhibition- Ki = 10 Micromol / L for of Omeprazole versus constant inhibition-     Ki = 0.69 Micromol / L for fluvoxamine. This indicates a more potent inhibition of CYP2C19 in     vivo of fluvoxamine compared to omeprazole. It is important to note that so far there is no     date in literature studies demonstrates that there is any interaction between fluvoxamine and     other CYP2C19 inhibitors and Clopidogrel.      Research goals:        -  To assess the impact of fluvoxamine and omeprazole on platelet reactivity in healthy          individuals treated with clopidogrel.        -  To verify weather the mechanism of omeprazole-clopidogrel interaction is related to          CYP2C19 inhibition.      Study design:      Randomized blinded placebo-controlled crossover trial on healthy volunteers. The response to     clopidogrel will be assessed using two methods in subjects receiving clopidogrel and one of     the study drugs: fluvoxamine, omeprazole or placebo.   "
153905|NCT01269320|"     This is a Single -arm, open-label, before-and after exploratory trial of 90 days of Femarelle     ® to improve NAFLD and the metabolic syndrome.      Ingestion of Femarelle will improve non alcoholic steatohepatitis and the metabolic syndrome     in patients suffering from these conditions.      Subjects will receive treatment with Femarele 530 mg (1 capsule twice a day) for 90 days and     will then be monitored off study treatment for an additional 4 weeks.   "
153906|NCT01269307|"     The purpose of this study is to determine if procedural sedation utilizing a 1:1 mixture of     propofol and ketamine is equivalent in complications, patient and physician satisfaction,     post-procedure pain level, and procedural outcome to propofol sedation alone.   "
153907|NCT01269294|"     The purpose of this study is to evaluate the effect of TMC435 on the results of     electrocardiograms (ECGs) in healthy volunteers. An electrocardiogram is an electric     recording of the heart. TMC435 is being investigated for the treatment of chronic hepatitis C     virus infection.   "
153908|NCT01269281|"     The objective of this study was to compare the relative bioavailability of Sumatriptan     Succinate Tablets 100 mg with Imitrex Tablets 100 mg under fed conditions in healthy adult     human subjects.   "
153909|NCT01269268|"     There was no sensitive and specific biomarker for tuberculosis infection, disease progression     and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate     and evaluate the newer biomarker for the diagnosis of TB infection. To investigate the new     biomarker for TB infection, the investigators will recruit the participants including active     TB patients, healthy household contacts, healthy community control.   "
153910|NCT01269255|"     A Phase I trial of Induction chemotherapy and Chemoradiotherapy with TS-1 and Cisplatin (SP)     as first-line treatment in patients with high risk advanced gastric cancer. Drugs used in     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed. Radiation therapy was effectively used in     esophageal cancer, laryngeal cancer and rectal cancer, but gastric cancer are rarely studied     in Korea. There is an increasing interest in preoperative radiotherapy in effort to improve     survival and increase pathologic complete response in patients with gastric cancer.     Chemoradiotherapy may be the best modality in the neoadjuvant setting for high-risk advanced     tumors, such as type IV or large type III, N3/bulky N2 metastasis, or locally advanced     tumors.   "
153911|NCT01269242|"     The main study objective is to assess the efficacy and safety of different bindarit dosages     compared to placebo in preventing restenosis, in patients submitted to coronary stenting and     using a bare metal stent (Vision BMS, by Abbott).   "
153912|NCT01269229|"     The purpose of this study is the increase of resection rate of primary cancer in rectal after     short course radiotherapy without interrupt chemotherapy schedule during the period of     chemotherapy. The subject should have the pathologically confirmed for unresectable     (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.      This trial contributes to save the time for decreasing primary tumor in rectal and metastasis     cancer to whole body after short course radiotherapy.   "
153913|NCT01269216|"     This is an open-label, randomized phase II study. Patients will be randomly assigned to     either FL or TS-1/irinotecan preoperative chemotherapy regimens by stratification. Patients     in FL group will be treated with bolus injections of 5-FU 400 mg/m2/day and LV 20 mg/m2/day     for 3 consecutive days every 4 weeks for 2 cycles, and patients in TS-1/irinotecan will be     treated with irinotecan 40 mg/m2/day on days 1, 8, 15, 22, 29. TS-1 at a dose of 35mg/m2 was     administered orally twice a day after a meal on the day of irradiation (Monday-Friday)     concurrent with radiotherapy.   "
153914|NCT01269203|"     The goal of this clinical research study is to learn if curcumin can reduce the symptoms     reported by patients with multiple myeloma (MM) who receive treatment with lenalidomide.   "
153915|NCT01269190|"     The goal of this clinical research study is to learn if new imaging devices can help doctors     decide if a lesion in the mouth is pre-cancerous or cancerous. The new imaging devices use     different colors of light in mouth imaging.   "
153918|NCT01269151|"     Multifocal-electroretinoram (ERG) and microperimetry are objective criteria to asses retinal     function. No information besides visual acuity exist for the development of retinal function     during the course of wet AMD during therapy with Lucentis. The aim of our study is to     evaluate the value of multifocal-ERG and microperimetry as an sensitive tool and early     predictor of recurrence of the disease. The second goal will be to evaluate the     neuroprotective effects of an adequate therapy on retinal function using microperimetry and     multifocal-ERG during the course of wet AMD.   "
153919|NCT01269138|"     FVII deficiency is a rare coagulation disorder. A limited number of patients are found in     most treatment centres and countries. Treatment demands vary considerably amongst FVII     deficient patients. Therefore, regular clinical studies will meet with recruitment problems     in this particular patient population. The present study intends to elucidate the bleeding     patterns in a well-defined collective of FVII deficiency patients who are carefully     characterised, to document the actual use of different treatment modalities in different     subgroups and to evaluate the efficacy and safety of current available treatment modalities     in bleedings, surgery and prophylaxis. The purpose is to gain some evidence based knowledge     of treatment of patients with FVII deficiency - an area where treatment decisions are made     more on personal clinical experience than on consolidated clinical evidence.      This study intends to register treatment practices as they are actually performed - in a     structured and documented way.   "
153920|NCT01269125|"     The investigators attempted to establish a rationale for the Gonadotropin Releasing     Hormone-agonist (GnRH-a) administration, post-laparoscopically, in women with mild     endometriosis (until stage II, according to AFS) who underwent IVF-ET procedure. Since GnRH-a     reduces cytokine's concentration in serum (Iwabe et al., 1998; Iwabe et al., 2003) and     peritoneal fluid of women with endometriosis (Taketani et al., 1992) the investigators     hypothesized that GnRH-a can reduces also cytokine's concentration in the follicular fluid     and this action may improve the oocyte quality and the fertility of these women.   "
153931|NCT01268982|"     In this study, the investigators will evaluate the dimensional changes of alveolar bone in     the preserved sites in comparison with extraction only conventional healed sockets, as well.        1. Dimensional changes of the alveolar ridge contour after socket preservation in          comparison to conventional tooth extraction.        2. Evaluation the stability of implants placed at the preserved sockets.        3. Histological evaluation of newly formed bone at the socket preserved sites in comparison          with extracted only healed sites.   "
153932|NCT01268969|"     Comparison between limberg flap and Karydakis flap for treatment of pilonidal disease.   "
153933|NCT01268956|"     Correlation of circulating lymphatic endothelial progenitor cells with lymph node metastasis   "
153921|NCT01269112|"     Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on     account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive     procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit     (regional anticoagulation) has been advocated as the method of choice.However, citrate     anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to     citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis     and hypocalcemia may occur.Implementation of citrate-based regional anticoagulation with     frequent monitoring of acid-base and electolytes is also more challenging for the nurses and     does not eliminate the need of a low-dose systemic anticoagulation for thromboses prophylaxis     in most of the patients. Citrate-based regional anticoagulation is therefore mainly advocated     only for patients at high-risk of bleeding.      The investigators plan to implement an open-label randomized control trial assessing the     effectiveness of citrate-based regional anticoagulation in critically ill patients with AKI     and with a special emphasis on the safety profile of this treatment in patients with severe     liver failure.   "
153922|NCT01269099|"     The increase in stress hormone level and hyperventilation caused by the postoperative pain     may contribute to the development of hypokalemia during postoperative period. Therefore, if     the postoperative pain is well controlled by the IV-PCA,the plasma potassium level during the     postoperative period may be not affected by stress response. The researchers tried to     investigate the effect of IV-PCA on potassium regulation during the postoperative period.   "
153923|NCT01269086|"     The purpose of this study is to determine whether a systematic family assessment in adult     preventive health visits increases the detection of risk factors in the spouse or adolescent     child of the screened person.   "
153924|NCT01269073|"     This trial is enrolling patients who are already being seen at OHSU sleep disorder center or     have been referred for clinical reasons by their physician to the OHSU sleep disorder center     and are going to have a sleep study that would be paid for by their insurance company for     clinical reasons.      The purpose of this study is to determine whether the Portland sleep apnea quiz has a higher     specificity and negative predictive value then the Berlin Sleep Questionnaire in a patient     population with a high predisposition to sleep apnea presenting to a sleep center.   "
153925|NCT01269060|"     Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single     incision (Embryonic NOTES) colon surgery has been attempted.      However, there are not sufficient evidences for single incision colon surgery in colon     cancer.      The investigators are researching the efficacy and safety of single incision laparoscopic     sigmoidectomy in sigmoid colon cancer.   "
153926|NCT01269047|"     The main purpose of the study is to determine the effects of 16 weeks of adjunctive     pramlintide or exenatide use on glycemic control in Type 1 Diabetes.   "
153927|NCT01269034|"     There are many recent advances in insulin treatment of type 1 diabetes, however after a meal     sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to     treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals.     This study is going to test whether this drug can improve the after meal sugars in people     with new onset type 1 diabetes. To test this you will be given a dose of exenatide (1.25 mcg)     and long acting insulin or inulin alone before the boost. There is also a placebo group     (healthy subjects) who do not get any medication before the boost. Insulin levels and other     hormones that affect blood glucose as well as your sugar will be measured by a series of     blood tests. The role exenatide as compared to insulin alone will be examined to prevent low     blood sugars which might occur because of food staying longer in the stomach than usual or     due to the suppression of a hormone called glucagon which increases blood sugar. If you     qualify you will be given exenatide (Byetta 1.25 mcg) along with insulin or insulin alone.     You and the researchers will not know which dose you are taking at any single visit. A total     of 20 people in which some will be children aged 12- 18 years will participate, being     diagnosed within 3 months of having been found to have type 1 diabetes.   "
153928|NCT01269021|"     In order to treat proliferative IgA Nephropathy(IgAN), The investigators designed an open,     prospective, randomized parallel study to access the efficacy and safety of MMF compared to     corticosteroid .      Patients who fulfill the inclusion criteria will be randomized in a 1:1 ratio to either the     MMF group or corticosteroid group.   "
153929|NCT01269008|"     Post-prandial hyperglycemia occurs despite meticulous carbohydrate counting and rapid acting     insulin therapy. Furthermore, this occurs even in the setting of the closed loop system.     Currently the algorithm used for calculating the glucose-responsive insulin delivery cannot     respond in a timely fashion to the glucose absorption resulting from a meal. In diabetes,     there is paradoxical immediate post-prandial hyperglucagonemia that results in immediate     post-prandial hyperglycemia. Amylin deficiency and/or dysregulated GLP-1 seems to be the     etiology. Pharmacologic replacement of these hormones alleviates immediate post-prandial     hyperglycemia in diabetes. With this protocol, the investigators would like to optimize     treatment of T1DM by physiologic replacement of hormones in addition to insulin and in the     process also optimize the insulin algorithm.      This is a paired, randomized, and controlled comparison of pramlintide and insulin versus     exenatide and insulin Vs insulin monotherapy using the ePID closed-loop system for insulin     delivery.      The investigators will stratify the study subjects into the following sub-groups of 5     subjects of 22-30 years old, 4 subjects of 18-21 years old, 4 subjects of 16-18 years old.     The investigators would also begin the study with the 21-25 year patient sub-group and then     transition to the other sub-groups after evaluating all the safety issues. 22-30 year old     ones would be considered as an adult subset, 18-21 year olds would be considered pediatric     subset according to the guidelines of FDA's Center for Devices and Radiological Health (CDRH)     and 16-18 year olds are considered typical pediatric population. At this time,     Spanish-speaking subjects will not be recruited because Medtronic Minimed as yet does not     have any literature in Spanish that may used in explaining the study to this group of     patients. When in the future Medtronic is able to provide us with the appropriate Spanish     literature, the investigators will at that time amend the protocol to include this group of     subjects.   "
153930|NCT01268995|"     New onset diabetes after transplantation (NODAT) is a frequent and feared complication after     kidney transplantation and leads to an increase in cardiovascular complications as well as in     the rate of graft loss. Very little data exist on how patients in which NODAT has been     diagnosed should be treated. It is suspected that Cylosporine A (Sandimmun, TM) is less     diabetogenic than Tacrolimus (Prograf, TM). Furthermore, it has been described that early     initiation of insulin treatment in Diabetes mellitus type 2 can preserve and improve the     function of the insulin secreting cells in the pancreas. Therefore, the investigators test     the effects of conversion from Tacrolimus to Cyclosporine A in patients with newly diagnosed     NODAT who have just started early treatment with insulin. The hypothesis is that patients who     are treated with insulin and who are switched to Cyclosporine A have improved glucose     metabolism compared to patients who are treated with insulin and who remain on Tacrolimus     therapy.   "
153936|NCT01268917|"     Antiplatelet therapy is critical in the management of coronary artery disease.For patients     undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of     preoperative antiplatelet therapy.And there is little study about the effect of continuing     aspirin until the surgery day on graft patency.So we would like to perform this study to     evaluate the effects of preoperative aspirin on graft patency and cardiac events in off-pump     coronary bypass.   "
153937|NCT01268904|"     To evaluate the safety and efficacy of intravenous valproate in pediatric status epilepticus     and acute repetitive seizures as part of seizure treatment protocol in pediatric ER   "
153938|NCT01268891|"     To evaluate the efficacy of a fixed dose of Azilect® (1 mg/day) vs placebo as assessed by the     change from baseline in mean total daily OFF time during 18 weeks of treatment in     levodopa-treated Parkinson's Disease (PD) patients with motor fluctuations in Korea.   "
153939|NCT01268878|"     The ending of this study is to describe the effect of febrile neutropenia on patients who     receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).   "
153940|NCT01268865|"     Background: In patients with chronic liver diseases, liver fibrosis staging is crucial for     hazard evaluation of future disease complication development and thus for the optimal     decision making on treatment selections.In the era of antiviral and antifibrotic treatments,     clinical and research demands are also increasing for non-invasive surveillance of liver     fibrosis to evaluate the progression or regression. However, local baseline data on liver     stiffness measurement (LSM) using ARFI technique is still lacking in Taiwan, where viral     hepatitides are highly endemic. Aim: Using the ARFI elastosonography, we are dedicated to the     aims to recruit patients based on strict but appropriate criteria, to complete the     correlation and validity studies between ARFI quantification and the referenced METAVIR     fibrosis scoring and to conduct subsequent innovative studies on liver diseases. Materials     and Methods: We plan to perform the ARFI quantification for each HBV or HCV-infected patient     immediately followed by priorly scheduled conventional liver biopsy for METAVIR scoring     during the same session of examination. Statistics: The first year's study using ARFI will     focus on the correlation testings and validity studies using receiver operating     characteristics.   "
153941|NCT01268852|"     The hypotheses tested in this study are: There is a statistical significant difference, in     treatment duration and result of treatment in cases treated using traditional Damon Q     brackets or using Insignia.   "
153942|NCT01268839|"     The purpose of this study is to investigate the pharmacokinetics of TMC278 (rilpivirine) 25     mg once daily following a preceding 2-week treatment period with efavirenz 600 mg once daily     in healthy volunteers   "
153943|NCT01268826|"     The aim of the study is to determinate the prevalence of moderate dehydration among children     aged 9 to 11 who are going to school.   "
153992|NCT01268189|"     This is a single-center, prospective, randomized, and controlled study to evaluate the     effectiveness of OxyBand Dressing for the use as a dressing for autogenous skin donor sites     compared to our current standard donor site dressing (Xeroform). Hypothesis is that the mean     healing time for wounds treated with the OxyBand dressing will be less than the mean healing     time for wounds treated with the Xeroform dressing.   "
153944|NCT01268813|"     The metabolic syndrome is a collection of related risk factors that predispose to the     development of type 2 diabetes Mellitus and cardiovascular disease. The investigators will     examine the hypothesis that the metabolic and genomic characteristics of patients with     metabolic syndrome and/or diabetes that are at risk for developing complications differ from     each other and can be detected using specific biomarkers in blood or in the exhaled breath.     Early detection of these individuals will enable personalized treatment to prevent and treat     diabetes and its complications   "
153945|NCT01268800|"     Personalization of AML therapy, require a reliable mechanism for accurate characterization of     patient specific leukemia phenotype and genotype. Patient's specific leukemic phenotype or in     practical clinical term, patient's leukemia sensitivity to induction therapy, should best     investigated in-vivo during induction. Elimination of circulating leukemic blasts from     peripheral blood by day 5 was shown to discriminate between good responders with superior     long term survival and poor responders with poor outcome. However, many AML patients have no     circulating blasts at diagnosis and even in those who have, elimination rate of it from     peripheral blood was never correlated with actual response in bone marrow.      Currently, the only available source for patient's specific leukemia profile, is the bone     marrow sample at diagnosis. Since leukemic blasts are heterogeneous and come from multiple     different clones, on diagnosis marrow consist a spectrum of chemotherapy sensitive and     resistance clones. Clones may vary by their molecular abnormalities and results from on     diagnosis marrow may overlook minor resistant but existing clones. Long term prognosis is     determined by those resistant clones and though our interests should be focused into the     abnormalities of these clones. Residual blasts on day 5 marrow may better represent the     profile of patient's leukemic resistant clones.   "
153946|NCT01268787|"     This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine     at a 0.25ml or 0.5ml dose in health volunteers   "
153947|NCT01268774|"     Patients with multiple myeloma have seen their survival rate strongly improved with the use     of new anti angiogenic agents. Among them, the new chemotherapy with thalidomide or     lenalinomide are frequently successfully suggested in therapeutic protocol such as MPT     however they can strongly increase the risk of venous thrombo embolic disease (DVT and PTE)     up to 20%. In these conditions, a prevention of this risk can be proposed by physician with     either low molecular weight heparin (LMWH) anticoagulants or antiplatelets agents. Pending     the new recommendations on the management of VTED, the purpose of this study is to describe     in real life conditions the management by oncologists of the thrombo embolic risk for such     patients   "
153948|NCT01268761|"     The aim of this study is to analyze the effectiveness of GnRh antagonist in the treatment of     early ovarian hyperstimulation syndrome.   "
153949|NCT01268748|"     This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than     conventional laparoscopic cholecystectomy.   "
153974|NCT01268423|"     The aim of the study is to determine if performing an early tracheostomy (within the first 4     days of endotracheal intubation) in critically ill patients on mechanical ventilation,     reduces the incidence of swallowing dysfunction.   "
153950|NCT01268735|"     Purpose To try to establish whether lid-parallel conjunctival folds (LIPCOF) can be     influenced by increased lubrication with rewetting and lubricating eyedrops containing     hydroxypropyl-guar, which has proven lubricating effect.      Methods During summer and fall of 2009, 16 ophthalmologists from various regions of Croatia     investigated the effect of topical therapy with lubricating eyedrops on the signs and     symptoms of dry eye, with the special emphasis on lid-parallel conjunctival folds (LIPCOF).     229 patients were enrolled in the study.      Results After 14 days of therapy with lubricating eyedrops containing hydroxypropyl-guar,     statistically significant reduction of LIPCOF grade was observed, as well as the reduction of     symptoms and other signs of dysfunctional tear syndrome (TBUT, Schirmer test, conjunctival     hyperemia).      Conclusion Results of this study have shown positive influence of lubricating eyedrops     containing hydroxypropyl-guar on signs and symptoms of dysfunctional tear syndrome even after     only 14 days of treatment. It is of particular interest that LIPCOF grade was statistically     significantly decreased, pointing at increased friction and decreased ocular surface     lubrication as possible causes of its appearance.      Having this in mind, every clinician involved in dysfunctional tear syndrome treatment must     also think about lubrication as integral part of treating this condition.   "
153951|NCT01268722|"     This is a multicenter double-arm randomized trial investigating plain balloon angioplasty     versus primary placement of self-expanding nitinol stents after endovascular recanalization     of femoral CTOs. Study will recruit up to 200 patients to be adequately powered for detection     of a significant difference in vessel patency after 1 year.   "
153952|NCT01268709|"     The objective of this randomized triple blind controlled trial is to compare the effects of     Doxepin and Nortriptyline on diarrhea predominant irritable bowel syndrome. In this stuy, 75     patients with IBS are randomly assigned to receive Doxepin , Nortriptyline or placebo, a     tablet per day, orally, for two months. Abdominal pain, mucus in the stool, incomplete     evacuation, and bloating are measured and compared between groups at the baseline and one and     two month after the intervention.   "
153953|NCT01268696|"     Metabolic syndrome is a combination of medical disorders that increase the risk of developing     cardiovascular disease and diabetes. The exact mechanisms of the complex pathways of     metabolic syndrome are not yet completely known. The pathophysiology is extremely complex and     has been only partially elucidated. Most patients are older, obese, sedentary, and have a     degree of insulin resistance. Stress can also be a contributing factor. The most important     factors are:      weight, genetics, aging, sedentary lifestyle,excess caloric intake. In our study we will     assess the role of some polymorphisms in the pathology of metabolic syndrome.   "
153954|NCT01268683|"     The study objective is to assess the feasibility of enrolling, evaluating, and treating with     RP-1127 (Glyburide for Injection) severe anterior circulation ischemic stroke patients,     whether or not treated with standard of care IV rtPA. Patients must be between 18-80 years of     age, must have a baseline diffusion weighted image (DWI) lesion volume 82 - 210 cm3, and time     from symptom onset to start of study infusion must be ≤10 hr.   "
154008|NCT01267981|"     The best preparation of small bowel is still unknown. The primary aim of this study is to     evaluate the polyethylene glycol (PEG) impact of small bowel preparation for unexplained     gastrointestinal bleeding exploration. Three different preparations are evaluated in this     study.   "
154059|NCT01267305|"     The purpose of this study is to determine whether the use of different dose of LMWH compared     with fondaparinux for thromboprophylaxis is efficacious and safety after thoracic surgery.   "
153955|NCT01268670|"     Background Approximately 30 million children are treated in emergency departments each year     in the United States, of which two to three million are children presenting with lacerations.     Topical numbing medication is the standard of care in children with regard to pain control     during laceration repair. While topical numbing medications are effective, children often     require further pain control during laceration repair in the form of an injected numbing     medication, which in itself is painful. No evidence currently exists regarding the concurrent     use of oral pain medications to combat laceration procedural pain.      Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and     tetracaine (LET) topical anesthetic provide more effective pain control than LET alone during     laceration repair?      Design This is a double-blinded, randomized-controlled study.      Methods Subjects in all three groups will receive topical anesthetic. In addition to topical     anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or     oxycodone, while the third group will receive a placebo.   "
153956|NCT01268657|"     The purpose of this study is to determine whether a brief intervention for disabling anxiety     is practical to conduct and beneficial for older adults injured by falls.   "
153957|NCT01268644|"     This study will add leptin therapy to the current insulin therapy of Type 1 Diabetics with     the aim of lowering the total insulin requirements and suppressing the steep fluctuations     typically associated with Type 1 Diabetes.   "
153958|NCT01268631|"     Hypothesis:      Response to therapy in fibromyalgia can be improved by coupling of specific medications to     the individual patterns of dysfunctional pain modulation. Individuals exhibit wide range of     pain modulating capabilities that can be assessed by dynamic psychophysical testing. Those     that exhibit less efficient endogenous analgesia and/or increased pain summation are known to     be more prone to suffer from pain. Tailoring medications to compensate for the specific     dysfunctioning modulatory mechanism will improve pain control.   "
153959|NCT01268618|"     Primary Objective:      • To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio     (professional label) in the improvement of symptoms in adult patients with     diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia      Secondary Objective:      • To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio     (professional label) in adult patients with IBS-D and functional dyspepsia   "
153973|NCT01268436|"     Toothache is a common source of pain for Emergency Department patients. There are several     common ways to control the pain of toothache. But we do not know if any one of them is more     effective than another. It is also possible that how we take care of your pain in the     Emergency Department will influence the level of pain you experience one or two days from     now. This study seeks to answer these questions.   "
154903|NCT01256294|"     The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to     branded tacrolimus (Prograf) in stable renal transplant patients.   "
153960|NCT01268605|"     Postoperative hypersensitivity (POH) is a problem for many patients as determined by the     recent Practitioners Engaged in Applied Research and Learning (PEARL) study of POH following     occlusal caries restoration. The objectives of this two-armed randomized comparative     effectiveness research trial (RCERT) are to determine whether adding a resin modified glass     ionomer liner (RMGI) reduces POH in dentin bonded Class I resin based composite (RBC)     restorations, and to identify other factors (putative risk factors) that are associated with     increased POH.      The primary outcome of this study is the reduction/elimination of restoration POH as measured     by clinical assessment (air stream) and patient-reports.      Outcomes will be ascertained via the following specific aims:      Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by clinical     measurement (air drying) and by patient-reported outcomes among the two treatment groups at     three points in time: prior to restoration and at one and four weeks postrestoration.      Specific Aim 2: To identify putative risk factors for POH (or factors associated with     differences in POH) including: preoperative caries stage measured by the proposed American     Dental Association (ADA) Caries Classification System (CCS), lesion depth as measured on the     preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation     depth, and patient sleep bruxism status.   "
153961|NCT01268592|"     The purpose of this study is to preserve the fertility potential in females diagnosed with     cancer by vitrifying (rapidly freezing) their oocytes (eggs) before undergoing treatment for     their cancer.   "
153962|NCT01268579|"     Human papillomavirus (HPV-16) is an important factor in the development of many tonsil and/or     base of tongue squamous cell cancers. Although HPV-16 is not thought to cause cancer by     itself, it appears to contribute to the development of tonsil and/or base of tongue cancer in     many patients. It is likely that treatment for many patients with tonsil and/or base of     tongue cancer could be improved if effective therapy to control HPV-16 is developed. The     investigators in this study want to learn if ribavirin shows evidence of activity against     HPV-16.      Ribavirin is a pill therapy that is approved by the Food and Drug Administration (FDA) as     part of the standard treatment for Hepatitis C. Laboratory experiments suggest that ribavirin     might also be useful in the treatment of head and neck cancers. However, ribavirin has not     yet been tested against head and neck cancer in patients. The purpose of this study is to     find out the effects of ribavirin on tonsil and base tongue squamous cell cancer in patients.      The main purpose of this study is to see if ribavirin changes the expression of certain     proteins related to HPV infection in the tumor. The study will also find out if ribavirin     changes how the tumor appears in a PET/CT scan (positron emission tomography/computed     tomography scan).   "
153963|NCT01268566|"     The primary objective of this Phase II study is to evaluate the progression-free survival at     6 months in adult subjects with a first recurrence of Glioblastoma Multiforme who are treated     with MEDI-575.   "
153965|NCT01268540|"     The purpose of this multi-center clinical trial is to determine the safety and efficacy of     the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive     astigmatism.   "
153966|NCT01268527|"     The purpose of this study is to investigate the efficacy, safety, tolerability and the     concentration/response relationship of E6201 in subjects with psoriasis vulgaris.   "
153967|NCT01268514|"     The objective of this prospective study is to evaluate short-term, mid-term, and long-term     clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of     complex abdominal wall defects   "
153968|NCT01268501|"     The purpose of this trial is to evaluate the use of multifocal contact lenses in people who     use reading glasses only.   "
153969|NCT01268488|"     The purpose of this study is to evaluate the performance of an investigational blood glucose     meter with the Contour sensor strip. It was decided that this investigational monitoring     system would not be part of a regulatory submission and it will not proceed to marketed     product.   "
153970|NCT01268475|"     Bronchiectasis can be defined as an abnormal and irreversible dilatation of the bronchial     tree due to repeated cycles of inflammation and infection, resulting in progressive loss of     lung function. The surgical treatment by pulmonary resection or even lung transplantation is     indicated in cases of bronchiectasis primary nonresponsive to appropriate medical treatment,     or when associated with serious complications. There are few literature data on the influence     of bronchiectasis in exercise capacity, quality of life and functional capacity, and the     impact of lung resection in patients with this diagnosis. The primary objective of this study     is to evaluate prospectively the impact of lung resection on exercise capacity in patients     with clinical and radiological diagnosis of bronchiectasis. The secondary objective of this     study is to evaluate the impact of lung resection on quality of life and lung function and to     analyze the the presence of predictors of postoperative functional deterioration and the     occurrence of complications.   "
153971|NCT01268462|"     In patients with obstructive lung disease like asthma aerosol therapy is the most used for     drug administration. A order to make better use of aerosolized drugs in asthmatic patients,     studies focus on ways to optimize this administration. Objective: To evaluate the efficacy of     nebulized bronchodilators carried by heliox associated with positive expiratory pressure     (PEP) in lung deposition of radiation activity in adult asthmatic patients between episodes     and its impact on lung function. Methods: A randomized controlled trial involving 32 with a     mean age of 47.28 ± 9.67 of which 25% of the sample are male, these patients were divided     into four groups: heliox + PEP, + PEP oxygen, heliox and oxygen in Regarding the     anthropometric characteristics, parameters and cardiopulmonary baseline spirometry data were     similar for all groups. For inhalation lung scintigraphy was used a noninvasive delivery     system - orofacial mask with two unidirectional valves nontoxic - inspiratory and expiratory     branch - connected to the nebulizer for radioisotopes associated with PEP of 10 cm H2O. At     the end of inhalation, the images were acquired in a scintillation camera at 0, 15, 30, 45     and 60 min. In order to analyze the aerosol deposition in different lung areas were     delineated regions of interest (ROIs) in the vertical - the upper, middle and bottom - and     horizontal central, intermediate and peripheral. Results: The spirometric data showed an     increase in the values of forced expiratory volume in one second (FEV1) predicted when     compared with the heliox group + PEP (80%, p = 0.030) with PEP + O2 (65%, p = 0.030). As for     CI, there was also an increase in PEP + heliox group (0.05 L, p = 0.012) compared to groups     without oxygen and heliox PEP (0.03 L, 0.03 L, p = 0.012 respectively) for the total number     of counts, no differences were seen between groups with heliox and oxygen with PEP PEP     (482510, 577598, p = 0.262 respectively) for the total number of counts by comparing the     oxygen group + PEP (577,598) with the heliox group (332,951, p = 0.004) and oxygen without     PEP (409,526, p = 0.045), there was a greater number of counts in the O2 + PEP group. By     analyzing the rate of pulmonary deposition (IDP) in the vertical gradient, higher deposition     in the middle third (p = 0.001) when compared to upper and lower in both groups. With regard     to IDPs in the horizontal gradient, there was greater deposition in the intermediate region     when compared to central and peripheral (p = 0.003, 0.001 respectively) in all groups. As the     penetration rate, no significant differences between groups (p = 0.726). When considering the     pulmonary clearance, decreased with the number of counts over time within groups (p <0.05)     but no differences between them: heliox + PEP (20.67%), PEP + oxygen (13.50%), heliox     (16.27%) and oxygen (16%) - (p> 0.05). Conclusion: Although no differences in the rate of     penetration and clearance of pulmonary radiation activity between groups, we noted a higher     number of counts in patients who underwent nebulization with oxygen associated with PEP and a     functional improvement in patients who underwent nebulization with PEP as spirometric values     and CI.   "
153975|NCT01268410|"     Acute respiratory failure is a common entity in intensive care units nowadays and is     associated with significant morbidity and mortality, thus representing a major health     problem. Most of the published epidemiological studies on this condition were performed when     modern ventilatory strategies and non-invasive ventilation were not available. Therefore, an     actual evaluation on the incidence and outcomes of this syndrome is mandatory. We will     perform an observational prospective study of patients admitted with acute respiratory     insufficiency in several ICUs in Brazil.   "
153976|NCT01268397|"     The purpose of this study is to examine whether operation and fixation with a metal plate     gives better result from the patient's perspective than plaster treatment in elderly patients     with a displaced wrist fracture.   "
153977|NCT01268384|"     The rationale for phase II trial of neoadjuvant fixed dose rate gemcitabine plus capecitabine     for patients with LAPC includes the following: First, obtaining a sufficient tumor     down-staging to procure R0/R1 resection, reported to be one of the most significant     prognostic factors for survival; second, providing an observation period to exclude from     surgery those patients with rapidly progressive disease there by to help select patients for     surgery who have the greatest likelihood of a favorable postoperative outcome; third,     eliminating micrometastatic disease, that is likely present in most patients, earlier than     adjuvant setting and preventing post-surgical growth spurts; fourth, adjuvant therapy given     in the neoadjuvant setting is better tolerated, as the patient has not recently undergone a     major operation; and the last, the lack of widely accepted optimal preoperative or palliative     approach in patients with LAPC, the majority of whom may not be operated on.      The primary goal is to determine the R0 resection rate of the neoadjuvant fixed dose rate     (FDR) gemcitabine-capecitabine combination chemotherapy in patients with borderline     resectable or unresectable locally advanced pancreatic adenocarcinoma.      The secondary goals are to assess progression-free survival (PFS) and OS (overall survival)     in these patients and to assess adverse events of these neoadjuvant treatments.   "
153978|NCT01268371|"     To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus     Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)   "
153979|NCT01268358|"     This is a single-center, open-label, dose escalation study of patients with     alpha-mannosidosis. 10 patients will be enrolled in this study receiving intravenous     infusions of Lamazym. In order to avoid development of delayed hypersensitivity all patients     will continue weekly treatment at the designated dose until the Safety Committee approves     transfer to the rhLAMAN-03 protocol.      It is the hypothesis that Lamazym is safe to use.   "
153980|NCT01268345|"     Blood glucose monitoring system are tested in the alternative site to validate the accuracy     of the blood glucose.   "
153981|NCT01268332|"     The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR     in HIV uninfected women over 12 weeks of use.   "
154917|NCT01256112|"     The purpose of this study is to determine whether a nutrition and physical activity education     program for families of overweight or obese adolescents with Down syndrome is more effective     when behavioral lifestyle change strategies are added.   "
153982|NCT01268319|"     The CANARY (Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow)     Study is a pivotal trial to evaluate criteria for defining a Lipid Core Plaque (LCP) that is     at high risk of rupturing during standard of care therapy and causing intra-procedural     complications. If plaques that require treatment are at higher than normal risk of causing     intra-procedural complications, some life threatening, the treating physician is better     informed and may opt to take precautionary measures to mitigate the risk or result of a     complication. The CANARY Study is also designed to evaluate the feasibility of using a distal     embolization protection device (EPD) as a means to prevent heart attacks triggered by the     embolization of plaque during standard care therapy. It is thought that the EPD will prevent     plaque from going downstream during treatment and obstructing other heart vessels. These     obstructions could cause heart attacks by preventing blood from reaching heart muscle tissue.   "
153983|NCT01268306|"     Corneal epithelial disruption, commonly termed corneal staining has been frequently     associated with contact lens wear. Previous research has demonstrated higher levels of     observed corneal staining when certain combinations of contact lenses and lens care products     are used, particularly under daily wear regimens. B+L lenses made from Balafilcon     (PureVision) have been associated with the highest rates of observed staining. Additionally,     polyhexamethylene biguanide (PHMB) based lens care products, specifically B+L ReNu MultiPlus     have been implicated in higher rates of staining. In general, many lenses constructed from     newer, silicone hydrogel (SiHy) materials appear more susceptible to increased rates and     amounts of corneal staining.      Although the clinical significance of staining is debated, most clinicians agree that less     staining is preferable to greater amounts of staining. Advances in understanding as well as     the specifics of lens care product formulation ideally will have resulted in design of newer     products that minimize corneal staining and maximize product performance. This study will     examine rates of corneal staining using B+L's recently introduced lens care product: BioTrue     with the B+L PureVision lens which has previously been associated with the highest levels of     staining.   "
153984|NCT01268293|"     The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg     when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1     cycle) in subjects with solid tumors   "
153985|NCT01268280|"     The primary objective of this early-stage clinical study is to demonstrate an effect of     single doses of CK-2017357 on measures of skeletal muscle function and fatigability in     patients with generalized myasthenia gravis (MG).   "
153986|NCT01268267|"     The purpose of this study is to evaluate the performance and acceptability of an     investigational blood glucose monitoring system, which includes meter and sensor strip.   "
154013|NCT01267916|"     It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive     end-expiratory pressure (PEEP) is present in grossly obese subjects especially in the supine     position. The investigators tried to investigate the effect of low respiratory rate and high     tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general     anesthesia.   "
154305|NCT01264328|"     The clinical hypothesis of this study is that the first-line treatment with the combination     of panitumumab and paclitaxel will provide benefit for patients with metastatic or current     Squamous Cell Carcinoma of the Head and Neck (SCCHN)   "
153987|NCT01268254|"     The investigators will evaluate 100 regular red wine consumer men and 100 abstainers men from     50 years-old to 70 years-old by coronary risk prevalence, mood status, anthropometric     measures, daily caloric ingest, lipid profile, carotid intimal media thickness, brachial flow     mediate dilatation, coronary tomographic angiography and leucocyte telomere length.      The sample size has been calculated expecting that regular red wine ingestion would lead to a     five year old younger vascular ageing indexes measured by carotid intimal media thickness,     coronary artery calcium scores and leucocyte telomere length longer than those abstainers     subjects at same age.      The investigators hypothesized that regular wine consumers present less coronary lesion and     coronary calcium score on coronary tomographic angiography, lower carotid intimal media     thickness and higher mean telomere length due the benefice of wine.   "
153988|NCT01268241|"     The current approved treatment for Fabry disease is enzyme replacement therapy (ERT). There     are actually 2 products in this therapeutic class available: Replagal® (agalsidase alfa) and     Fabrazyme® (agalsidase beta). Both are indicated for long-term treatment in patients with a     confirmed diagnosis of Fabry disease (alfa-galactosidase A deficiency). Both have been     commercially available in Europe for almost 10 years, yet little information is available     about the clinical and safety profile of patients who switch from one therapy to the other.     An extended shortage of Fabrazyme® that began in June 2009 has necessitated that a large     number of patients switch from Fabrazyme® to Replagal®. This offers the possibility to study     the clinical status and adverse events in patients who switch from Fabrazyme® to Replagal® on     a large-scale basis. In addition, as a result of the increasing Fabrazyme® shortage, many of     these patients received a reduced dosage of Fabrazyme® for an extended period before     transitioning to treatment with Replagal®.   "
153989|NCT01268228|"     The coronary bifurcation lesions pose a therapeutic problem with high rates of periprocedural     complications, higher rates of in-stent restenosis and stent thrombosis. These are lesions     where stenting is not superior in comparison to balloon angioplasty in regard to side branch.     It was demonstrated many times, in literature and in daily practice, that angiographically     high grade ostial side branch stenosis is not flow limiting and do not cause ischemia,     therefore do not require treatment. From the other side, our own data with MRI before and     after bifurcation PCI demonstrated that occurrence of angiographic stenosis more than 70% in     diameter is associated with periprocedural myonecrosis in the region of side branch. This     fact puts a very important question about the mechanisms of this myonecrosis. If the jailed     side branch has no significant flow limiting stenosis, but there is some degree of residual     ischemia, which after some period of persistence could lead to myonecrosis, will mean that     more aggressive treatment of ostial stenosis is needed. It is interesting that the strategy     of treatment is very important, because techniques with second stent implantation (with     primary purpose to limit SB ischemia) are associated with higher grade of troponin increase.     Of course this is association and not causality, despite that in randomized study (NORDIC I)     it was confirmed also.      It is without explanation the fact of rare occurrence of significant (flow limiting, FFR     <.75) stenosis appearance (less than 40% in side branches with ostial stenosis more than 75%)     and almost 50% periprocedural myonecrosis detected in the side branch areas. One working     hypothesis is that stent implantation and related episode of ischemia induces prolonged     vasospasm, resulting in prolonged ischemia. Thus, the ostial stenosis could be     non-significant as estimated and registered by FFR, but on microcirculatory lever ischemia     could persist is small areas for which available flow is not sufficient despite that global     regional flow is deemed sufficient. It is also possible that those patients have not enough     recruitable collaterals. It is also possible that both factors act together.      Although FFR is useful for assessing the degree of ischemia caused by a coronary lesion, it     cannot give information as to whether this ischemia may be clinically significant or not,     i.e. whether the ischemia affects a large territory. Therefore, it can be implicated that FFR     may not be useful in predicting clinically meaningful ischemia in a specific side branch     vessel.      The intracoronary electrocardiography (i.c. ECG) is a very sensitive method for ischemia     detection. The i.c. ECG reacts earlier on ischemia; the changes are much more prominent and     easy to register. The wire tip could be positioned directly in different regions and thus to     map regional ischemia. In most of the studies and from our own observations became evident     that when surface ECG do not react the i.c. ECG demonstrates significant changes in     ST-segment and QRS complex. Moreover, the registration of i.c. ECG is very cheap and needs     only an adapter connecting coronary wire end and ECG. An i.c. ECG also can differentiate     residual ischemic changes in distal main vessel and side branch as sources of prolonged     ischemia, respectively - source of periprocedural myonecrosis.      The objective of this study is to evaluate the clinical significance of side branch vessel by     occluding the blood flow with a 1-minute balloon occlusion. We will also assess whether there     is any change in ECG (i.c. and 12-lead surface records) on balloon occlusion and relation     with periprocedural myonecrosis.   "
153990|NCT01268215|"     A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of     pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic     treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low     birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the     tracheal aspirate before and after instillation of the study drugs.   "
153991|NCT01268202|"     Molecular mechanisms involved in radio-induced fibrosis are assessed in UPRES EA 27-10 since     10 years. Besides the canonical TGFbeta/ Smad pathway involved in radio-induced fibrosis     (RIF), the Rho/ROCK/CTGF cascade has been shown to be also implicated in molecular mechanisms     of RIF. Curative administration of Pravastatin or ROCK specific inhibitors inhibits the     chronically activated Rho/ROCK/CTGF pathway in vitro in human cells lines and ex vivo in     human samples. In addition, the curative administration of Pravastatin improves established     RIF in vivo. The investigators data suggest that the pravastatin-based strategy is an     efficient and safe antifibrotic therapy, easily transferable into the clinic to improve the     quality of life of long-term cancer survivors without interfering with prior anticancer     treatment.      This clinical trial evaluates the curative efficacy of Pravastatine in patients who presented     a cutaneous and/ or subcutaneous fibrosis (grade >= 2 according to NCI-CTCAE v4 toxicities     scale) and who were treated by radiotherapy for a head and neck cancer. Patients will be     treated by Pravastatin during 12 months. An intermediate evaluation of efficacy by ultrasound     will be assessed at 6 months and at last, at the end of the treatment. Patients assessment     will be performed at 6 and 12 months after the end of the treatment to look at a potential     rebound effect.      Objective(s) of the clinical study      Main objective: To assess Pravastatin efficacy in established cutaneous and subcutaneous     radio-induced fibrosis revealed from 6 to 24 months after head and neck radiotherapy.      Second objective: To evaluate radio-induced fibrosis regression during the year following     treatment stop.   "
153993|NCT01268176|"     This study seeks to determine if vitamin D3 absorption in healthy adults will be enhanced in     the presence of a meal and if the enhancement will be greater when the meal is low as opposed     to high in fat content. The enhancement will result from increased vitamin D absorption. The     investigators will test this hypothesis by pursuing the following aims in a 3-mo trial in     which up to 70 healthy men and women will be randomized to one of the following meal     conditions under which they will take a monthly oral dose of 50,000 IU of vitamin D3: no meal     (fasting), a low fat meal, or a high fat meal. The Primary Aim is to identify the meal     condition (fasting, low-fat, or high-fat meal) under which the 25OHD3 response to     supplemental vitamin D3 is greatest and most consistent. The Secondary Aim is to determine     whether vitamin D3 absorption is affected by the meal condition and to determine whether the     absorption of vitamin D3 predicts the longer-term 25OHD3 response to supplementation.   "
153994|NCT01268163|"     The purpose of this study is to compare the pharmacokinetic and safety characteristics of     European Taxotere® and American Taxotere® with Hospira Docetaxel injection in patients with     cancer.   "
153995|NCT01268150|"     The purpose of this study is to assess the efficacy and safety of single-agent eribulin     mesylate for first-line treatment of subjects with locally recurrent or metastatic breast     cancer.   "
153996|NCT01268137|"     This study aims at assessing efficacy and safety of DBS for treatment of patients suffering     from resistant major depression, by means of a random, controlled and crossed study.   "
153997|NCT01268124|"     This is a phase 1, randomized (a process that is used to decide whether you will take study     drug or a placebo during the study), inpatient study which will assess the safety and     tolerability of HTC-867 in healthy male Japanese subjects.   "
153998|NCT01268111|"     Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D     replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before     and after the intervention, and the changes will be compared between the two groups. This     will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol     Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are     mediated by RBP4.   "
153999|NCT01268098|"     Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults     with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and     vitamin D supplements.   "
154109|NCT01266655|"     There is first evidence from preclinical and clinical studies for the efficacy of the     selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of     this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen     for relapse prevention in alcohol-dependent patients.   "
154000|NCT01268085|"     In recent years, multiple articles have highlighted the increased risk of developing cancer     from ionizing radiation. The risk increases with higher radiation doses, and accumulates with     repeated scans.      Hospitals with computerized physician order entry systems (CPOE) have the unique opportunity     to use decision support on radiation safety to influence a physician's ordering practice in     real-time. An ideal decision support tool for radiation safety will educate the physician     about the dangers of cumulative ionizing radiation, present the patient's image history, and     guide the provider to the best modality that meets the patient's diagnostic needs with as     little radiation exposure as possible. The design challenge is to create a decision support     tool that appropriately protects the investigators patients from overutilization of CAT     scans, without inadvertently leading to underutilization of CAT scans or inappropriate     utilization of alternative tests.      This research protocol proposes to study one such design at a large, academic medical center.   "
154001|NCT01268072|"     The primary objective of this study is to identify biomarkers that can be used for evaluation     of efficacy in subjects presenting with AECOPD   "
154002|NCT01268059|"     The purpose of this study is to evaluate the dose, antitumor activity, safety and     pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with     previously untreated, advanced non-small cell lung cancer (NSCLC).   "
154003|NCT01268046|"     This study will focus on how aging affects changes in the way the brain works when affected     by estrogen in areas of the brain associated with memory.   "
154004|NCT01268033|"     Background      Idiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with     immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine).      Renal function of patients suffering from severe, steroid-dependent nephrotic syndrome with     failure or toxic side effects of other immunosuppressant treatments is a major matter of     concern.      Cyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this     treatment for years. At the same time, low doses of cyclosporine allow proteinuria to     reappear, which provokes degradation of renal function by focal segmental glomerulosclerosis.     Some recent data lead to the conclusion that Rituximab may be effective in such a disease,     with a cyclosporin sparing effect.      Purpose      The aim of the study is to evaluate the efficacy of Rituximab versus placebo in the treatment     of pediatric patients suffering from severe cyclosporine-dependent nephrotic syndrome.      Abstract Patients will be included in the study in a period of remission of proteinuria. Two     infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one     week of interval. Other immunosuppressant treatments will be gradually tapered off with the     same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding     code will be broken. Rituximab will then be infused to patients having received placebo.   "
154005|NCT01268020|"     The underlying goal of this study is to assess [18F]-FMH3 PET imaging as a tool to evaluate     the activity of the H3 receptor in the brain of Alzheimer Disease (AD) research participants   "
154006|NCT01268007|"     This is an observational, un-blinded, non-significant risk, non-interventional study designed     to collect ECG data on at least one subject out of a pool of up to three (3) healthy male     subjects at one clinical site (Clinical Trials of Texas). Cyberonics will be collecting ECG     recordings collected by an investigational device for comparison with conventional ECG     recordings. This data will be used to validate a new device under development.   "
154007|NCT01267994|"     The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist)     can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED)     that did not respond to oral steroid therapy for a sudden decline in hearing. The patients to     be enrolled will have recently completed a course of oral steroids and demonstrated no change     in their audiometric thresholds following corticosteroid therapy.   "
154980|NCT01255293|"     The purpose of this study is to assess the retinal redetachment rates with 1000 centistoke     versus 5000 centistoke silicone oil tamponade for repair of complex retinal detachments.   "
154009|NCT01267968|"     GSK2251052 is a member of a novel mechanistic and structural class of antibiotics that     inhibits the bacterial enzyme leucyl tRNA synthetase (LeuRS) by forming a boron adduct with     tRNA and is currently in development for the treatment of hospital acquired Gram-negative     infections (including E. coli, K. pneumoniae, and Enterobacter spp.).      This is an open-label, randomized, single period, parallel-cohort pharmacokinetic study to     evaluate serum and pulmonary pharmacokinetics following single dose and multiple dose     administration of intravenous GSK2251052. In Cohort 1, approximately 15 healthy adult     subjects will be randomized to receive a single IV dose of GSK2251052 1500 mg in the fasted     state. Following the dose, bronchoalveolar lavage (BAL) fluid and serial plasma samples will     be collected for determination of GSK2251052 parent and metabolite concentrations. In Cohort     2, approximately 15 healthy adult subjects will receive GSK2251052 1500 mg IV BID x 5 doses     (Cohort 2). Following the last dose in the fasted state, bronchoalveolar lavage (BAL) fluid     and serial plasma samples will be collected for determination of GSK2251052 parent and     metabolite concentrations. Vital signs, ECGs, and adverse events will be monitored throughout     the study. A follow up visit will occur 10 to 14 days after the last dose of study drug.   "
154010|NCT01267955|"     This phase II trial studies how well vismodegib works in treating patients with     chondrosarcomas that have spread to other places in the body and usually cannot be cured or     controlled with treatment. Drugs used in chemotherapy, such as vismodegib, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading.   "
154011|NCT01267942|"     Null hypothesis; The efficacy of Enhancin]Co-Amoxiclav given as a single intravenous dose at     induction is not better than a five days oral course of the same given postoperatively in     reducing postoperative morbidity after adenotonsillectomy.   "
154012|NCT01267929|"     This study aimed to develop Video Compact Disc (VCD) program that applying the concept of     imitative learning with mirror neurons stimulation on standard rehabilitation technique in     children with cerebral palsy. The author will also examine effectiveness of the program by     compare the motor function measured by the gross motor function measure (GMFM-66) between     conventional physical therapy and the mirror neurons stimulation based VCD program for six     months.   "
154306|NCT01264315|"     Rationale: We recently reported a study where overall and event free survivals in newly     diagnosed myeloma patients receiving an autologous transplant followed by an allograft from     an HLA-identical sibling were superior as compared to those undergoing a double autologous     transplant. A larger multicenter study by the Gruppo Italiano Trapianti di Midollo (GITMO),     co-ordinated by our group and recently closed, employing a tandem auto-allo approach in newly     diagnosed patients confirmed the achievement of prolonged event free and overall survival.     Importantly, the achievement of at least very good partial remission at the time of     allografting conferred a significant advantage in both event-free-survival (HR 0,23, CI     0,11-0,48; p=0,0001) and overall survival (HR 0,26; CI 0,09-0,79; p=0,02). Moreover, recent     advances in the understanding of the pathogenesis of multiple myeloma have identified     specific signalling pathways that have become targets for biologically-based drugs such as     thalidomide, bortezomib and lenalidomide and employed in several trials, including after     allograft. The aim of the current proposal is to combine the post-transplant efficacy of     graft-vs.-myeloma with the anti-myeloma effect of lenalidomide in newly diagnosed myeloma     patients with an HLA-identical sibling treated with a tandem autograft-allograft approach.     Maintenance/consolidation of the response may be a key factor to further improve rate of     clinical and molecular (as a prelude to cure) remissions and prolong overall and event free     survivals after allografting. We would like to investigate the safety and efficacy of     lenalidomide as consolidation/maintenance therapy in patient undergoing tandem     autologous-allogeneic transplant.      Objectives of study: To evaluate 1) toxicity and tolerability of lenalidomide after     allografting; 2)To evaluate efficacy of lenalidomide in inducing complete remission, defined     as negative immunofixation, 12 months after allografting; 3) overall-survival; 4) event-free     survival; 5) molecular remission rate. Furthermore we plan to compare molecular remission     rate in patients treated with lenalidomide after tandem auto-allo transplant and after double     autologous transplant and to monitor minimal residual disease in patients achieving clinical     CR with lenalidomide.      Patient Selection: Patients with newly diagnosed multiple myeloma with an HLA identical     sibling suitable for PBSC donation will be included. Complete cytogenetic analysis at     diagnosis will be required. The patient must have the capacity to give informed consent. Age     >18 and < 65. Negative pregnancy test and willing to use contraceptive techniques during and     for 12 months following treatment is required. Only very unfitted patients will be excluded.      Treatment plan: Lenalidomide will be started at 6 months post-allotransplant at the dose of     10 mg/day continuously in all patients (unless in molecular CR), if the following conditions     are present:        -  absolute neutrophil count > 1 x 109/L without the use of growth factors;        -  platelet count > 75 x 109/L without transfusion support;        -  calculated or measured creatinine clearance: ≥ 20 mL/minute;        -  total bilirubin < 2 x the upper limit of normal,        -  AST and ALT < 2.5 x upper limit of normal        -  less than 1 mg/kg/day of prednisone, and no more than 2 immunosuppressive drugs other          than steroid to control GVHD (if more immunosuppression is required to control GVHD, the          maintenance therapy with lenalidomide will be held until this criteria will be          satisfied) Treatment will be continued without interruption, unless not tolerated, until          unacceptable adverse events are experienced or progressive disease occurs. Moreover,          lenalidomide will be discontinued in patients who achieve and maintain molecular          remission for 2 consecutive controls at least 6 weeks apart.      Safety section - dose modification plan: During the study patients will be monitored for the     occurrence of side effects. Toxicity events will be graded according to the NCI toxicity     criteria. In case of severe toxicity, the lenalidomide dose will be reduced or withheld as     outlined in the protocols.      Statistical section: - Total patient sample size: 53. This is a phase 2 study designed     according to a Simon's two-stage Minimax Design. An early stopping rule will be established     to interrupt the study in case of futility (a non satisfactory response rate). In stage I 27     patients will be enrolled; if < 14 complete remissions will be observed, the trial will be     stopped. In stage II 26 more patients will be enrolled. If ≥ 32 responses will be observed,     it will be concluded that the lenalidomide maintenance is active in increasing the complete     remission rate after auto-allograft.      Analysis plan: Toxicity monitoring will be incorporated into the study design by requiring     that the trial be terminated after an initial stage if the number of observed toxicities     (treatment related deaths) is excessive.   "
154014|NCT01267903|"     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused     by viruses that belong to the enterovirus genus of the picornavirus family. Although most     HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71     (EV71) can present with a high rate of neurological complications, including     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by     EV71 has become a major emerging infectious disease in Asia and the highly pathogenic     potential of EV71 clearly requires the attention of world medical community.      The development of vaccine against EV71 is active and ongoing in Asian countries now. Several     studies have examined the effectiveness of inactivated viral vaccines against EV71 in animal     model. A wide range of experimental EV71 vaccine approaches have been studied including     heat-inactivated or formaldehyde-inactivated virion, EV71 virus-like particles (VLP) , VP1     recombinant protein ,VP1 DNA vaccine , VP1 peptide-based vaccine targeting the neutralizing     domain, bacterial or viral vector expressing VP1, and a Vero cell-adapted live attenuated     virus. Furthermore, neutralizing antibodies against EV71 have been suggested as one of the     most important factors in prevention of the severe EV71 infection. Recently, an inactivated     vaccine(vero cell) against EV71 has been licensed by SFDA in China, this clinical trial phase     Ia is armed to evaluate safety and tolerance in Chinese healthy adults and children.   "
154015|NCT01267890|"     This study is a prospective cross-sectional survey study. The investigators developed     self-administrated questionnaire and recruit 120 physicians in two hospitals and 60 lawyers     from some law firms to this study.      To realize and compare the opinions of physicians and lawyers about controversial     decision-making of surrogate.   "
154016|NCT01267877|"     The purpose of this study was to determine attitudes regarding the 2009 USPSTF Guidelines for     breast cancer screening for women in their 40's and assess the effect of one of two newspaper     articles on their attitudes. The population studied was women seeing their private     gynecologist for annual exams in the 39-49 year old age group.   "
154017|NCT01267864|"     This randomized study is testing 3 different intravenous medications to see which one is best     for acute migraine. The three medications are metoclopramide, valproate, and ketorolac.   "
154018|NCT01267851|"     The database and biobank establishment started in 1997 in our institute. However, the sample     size was too small with respect to our clinical and fundamental scientific research's     requirement. Thus the Chinese gynecological oncology study (GOS) group was established to     create a large multicentre database and biobank of patients with gynecologic diseases.   "
154028|NCT01267721|"     It has been repeatedly demonstrated that cardiac surgery with the use of extracorporeal     circulation elicits a systemic inflammatory response and provokes ischemia-reperfusion     related oxidative stress which could further lead to the development of organ failure in     critically ill patients. Perioperative levels of macrophage migration inhibitory factor (MIF)     and other inflammatory mediators could be involved in adverse outcomes in cardiac surgery.   "
154029|NCT01267708|"     The purpose of this study is to examine PLT function in PCI patients.   "
154030|NCT01267695|"     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Perioperative imatinib mesylate may shrink the tumor and may reduce the     chance of relapse after surgery. This phase II trial is studying the effectiveness of     perioperative imatinib mesylate in treating patients with locally advanced gastrointestinal     stromal tumor.   "
154031|NCT01267682|"     The purpose of this study is to test the effectiveness of cognitively stimulating activities     for resolving delirium in people with dementia.   "
154996|NCT01255085|"     It is hypothesized that yellow pea protein and fiber will reduce short-term food intake,     subjective appetite and glycemic response.   "
154019|NCT01267838|"     BBK- 2 - study:      STUDY-SUMMARY      Background:      The need for stenting of the main and side branch (double stenting) in the treatment of     coronary bifurcation lesion primarily depends on the complexity of the bifurcation lesion. If     the bifurcation lesion is very complex (Medina classification 111, severe stenosis of both     branches, severe calcified lesion, long lesions etc.) double stenting may be the treatment of     choice. When double stenting is required, the most frequently used stenting techniques are     T-stenting and Culotte-stenting. It is still unclear, however, which double stent technique     yields the best long-term outcome.      Aim:      This randomized study will compare the long-term safety and efficacy of T-stenting versus     Culotte-stenting in the treatment of de-novo coronary bifurcation lesions with drug-eluting     stents.      Methods:      Three-hundred patients in whom a double-stenting technique is intended for the treatment of a     de-novo coronary bifurcation lesion will be randomly assigned to T-stenting or     Culotte-stenting with an approved drug-eluting stent. Patients will undergo 9-month     angiographic follow-up with quantitative coronary angiography. Clinical follow-up is planed     at 30 days, 6 months, 1 year, 2 years, 3 years and 5 years. The primary study endpoint is the     maximal percent diameter stenosis in the bifurcation lesion at 9 months. Secondary endpoints     include binary restenosis (estimated by Quantitative Coronary Angiography (QCA) analysis),     Target Lesion Revascularisation (TLR), Freedom from Major Adverse Cardiac Events (MACE) and     the rate of stent thrombosis according to the definition of the Academic Research Consortium     (ARC definition). The study will have 90% power to detect a 25% reduction in the primary     endpoint at p < 0.05.   "
154020|NCT01267825|"     Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe     that it is functionally disabling. The purpose of this randomized clinical trial is to     determine if corticosteroid medication, delivered directly to the area near the herniated     disc, can improve the pain and functional disability associated with a herniated disc.   "
154021|NCT01267812|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Giving bortezomib     together with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib and rituximab together     works in treating patients with mantle cell lymphoma who have previously undergone stem cell     transplantation   "
154904|NCT01256281|"     The hypothesis of this study is:      Femoral nerve blocks can feasibly be performed on patients with Sickle Cell Disease and     painful crisis in the Emergency Department.   "
154022|NCT01267799|"     Photocopiers are indispensable in today's working environment. However, photocopiers emit a     number of harmful chemicals during their operation. Photocopier toners also contain a number     of potentially toxic substances. Chronic exposure to these substances may compromise the     health of photocopier operators. This study is aimed to understand if chronic exposure to     photocopier emissions is harmful to human health.   "
154023|NCT01267786|"     The aim of the study is to investigate the effect of sevoflurane and desflurane on hepatic     function after ischemic/reperfusion injury and the sequence influence on renal and     cardiovascular systems.   "
154024|NCT01267773|"     Having both depression and conduct problems at the same time has been found to be associated     with increased risk for the other and increased risk of negative outcomes. This study will     develop an family based cognitive behavioral treatment protocol for youths with both conduct     problems and depression, that will take be administered over the course of six months. Youth     with comorbid conduct problems and depression will be assigned to the experimental condition     or treatment as usual in a community care setting. The treatment manual will be revised as     needed. Youth will be assessed before and after treatment to examine program potential. The     goal of this research is to develop a more comprehensive outpatient treatment for youth with     both conduct problems and depression.   "
154025|NCT01267760|"     The purpose of this study is to investigate whether recycled dialysis fluid can supply enough     clearance for hemodiaysis patients.   "
154026|NCT01267747|"     Primary objective of the PAPPHY Study is to establish the prevalence of primary aldosteronism     (PA) in consecutive hypertensive patients hospitalized for lone (non valvular), paroxysmal,     persistent or permanent atrial flutter or fibrillation (AFF).      Secondary objectives are to identify:        1. the clinical, echocardiographic and biochemical predictors of AFF in the hypertensive          patients with/without PA;        2. if AFF, by increasing ANP and/o BNP thereby conceivably blunting aldosterone secretion,          can lower the ARR and impede PA detection.        3. the usefulness of the aldosterone-to-renin ratio (ARR) based on plasma renin activity          (PRA) and the direct measurement of renin (DRA) for diagnosing PA in patients with AFF.        4. the rate of recurrence or new onset AFF during follow-up in a cohort of hypertensive          patients with/without PA as a function of specific treatment for the latter.      Design: cohort multicenter prospective study. Sample size: 1000 consecutive patients.      Procedure At baseline cardiac function, arterial stiffness, and plasma renin activity (PRA),     direct renin assay (DRA), plasma aldosterone (PAC) will be measured. Pharmacologic or direct     current cardioversion (DCC) will be performed if indicated according to 2010 ESC guidelines.      PRA and PAC will be measured again 2 weeks after cardioversion to answer secondary aim b.      If ARR is > 26 and PAC > 15 ng/dL, adrenal vein sampling (AVS) will be performed in patients     willing to undergo adrenalectomy to identify a lateralized PAC excess.      Follow-up will be aimed at assessing damage organ, occurrence of cardiovascular events and     recurrence of AFF in patients with or without PA.      Demonstration of a higher prevalence of PA in the patients with AFF as compared to the     general population of the hypertensive subjects will provide evidence for 1) a role of     aldosterone excess in causing AFF and cardiac electric remodeling; 2) the usefulness of case     detection of PA in hypertensive patients with AFF; 3) the predictors of AFF; 4) the outcome     of specific treatment for PA on risk of incident and recurrent AFF.   "
154027|NCT01267734|"     Objectives        1. To compare the safety and long-term effectiveness of coronary stenting with the new          platform Everolimus-Eluting coronary stenting system (EECSS, Promus Element) compared          with the Zotarolimus-Eluting coronary stenting system (ZECSS, Endeavor Resolute) in          patients with coronary heart disease (CHD)        2. To determine the short-term efficacy and safety of triple anti-platelet therapy (TAT,          Aspirin 100mg qd, Clopidogrel 75mg qd and Cilostazol 100mg bid) compared with          double-dose clopidogrel dual anti-platelet therapy (DDAT, Aspirin 100mg qd and          Clopidogrel 150mg qd) in patients undergoing percutaneous coronary intervention (PCI)          with drug-eluting stents (DES)      Study design Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to     test the following in CHD patients        1. Non-inferiority of Promus Element stent compared with Endeavor Resolute stent in          reducing target lesion failure (TLF)        2. Non-inferiority of TAT compared with DDAT in reducing net clinical outcome Patients will          be randomized in a 2-by-2 factorial manner according to the type of drug eluting stent          (EECSS vs. ZECSS) and the type anti-platelet regimen (TAT vs. DDAT). Randomization will          also be stratified per presence of DM.      Patient enrollment 3750 patients enrolled at 50 centers in Republic of Korea      Patient follow-up Clinical follow-up will occur at 1, 3, 12, 24, 36 months after the     procedure. Angiographical follow-up will be recommended to all participants at 13 months     after the procedure. Investigator or designee may conduct follow-up as telephone contacts or     office visits.      Primary endpoint        1. Target lesion failure (TLF), defined as a composite of cardiac death, target          vessel-related myocardial infarction (MI) and ischemia-driven target lesion          revascularization (TLR) up to 12 months for the stent arm        2. Net clinical outcome, defined as a composite of cardiac death, nonfatal MI, CVA and          major bleeding by PLATO criteria at 1 month for the anti-platelet arm   "
157465|NCT01222884|"     The purpose of this study is to compare the efficacy and safety of intravenous iron     isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic     Kidney Disease on Dialysis Therapy (CKD-5D).   "
154032|NCT01267669|"     Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of     acute variceal bleeding and five-day haemostasis has been shown to significantly improve when     vasoactive drug is added. However, there is limited data whether addition of somatostatin, to     endoscopic variceal ligation (EVL) improves the efficacy of EVL.      Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal     bleeding.      Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from     esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized     to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was     treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour     after start of therapy or death.   "
154033|NCT01267643|"     Aplastic Anemia (AA) is an autoimmune hematologic stem cell disease mediated by activated     T-lymphocytes that leads to pancytopenia. The disease related morbidity and mortality if left     untreated can approach 90%. For over 30 years, anti-thymocyte globulin (ATG) in combination     with cyclosporine (CsA) remains the standard therapy. However, the treatment response with     ATG is at best between 50-60% with a sizeable number of partial responses. Treatment with ATG     is also associated with significant toxicity and high relapse rate that can be as high as     45%. Since the prognosis in refractory and relapsed AA remains poor, there is a need for less     toxic novel immunosuppressive agents that can improve response rates and remission duration     in refractory and relapsed AA.      Alefacept is a human recombinant dimeric fusion protein composed of the terminal portion of     leukocyte functioning antigen-3 (LFA3/CD58) and the Fc portion of human IgG1. It prevents     co-stimulatory signals between antigen presenting cells and memory T cells by competitive     inhibition of CD2 in T cells, induces selective apoptosis of CD4+ and CD8+ memory effector T     cells by interaction between the Fc portion of IgG1 and the FcyIII in NK cells, and possibly     direct ligation of CD2 molecules on T cells that subsequently result in the alteration in T     cell agonist signaling. It has been used successfully in the treatment of other T cell     mediated disorders particularly psoriasis and steroid refractory graft versus host disease     (GVHD) with minimal side effects. In a case of liver transplant associated AA (similar to     transfusion associated AA) which is fatal in most patients, Alefacept induced remission after     patient did not respond to ATG and other immunosuppressants. The investigators hypothesize     that the LFA3-CD2 co-stimulatory pathway play an important role in the immune pathogenesis of     AA and treatment with Alefacept can help treat refractory/relapsed cases of AA.   "
154034|NCT01267630|"     The purpose of this study is to determine the validity and reliability of the Thai version of     the Confusion Assessment Method for the intensive care (CAM-ICU) in the elderly and the     prevalence of delirium in elderly.   "
154035|NCT01267617|"     To determine if proprietary software that uses pulse-wave analysis to interpret the output of     a conventional pulse-oximeter, can predict the onset of circulatory stress, before changes in     blood pressure and pulse occur, in patients undergoing outpatient hemodialysis.   "
154036|NCT01267604|"     An efficient protocol of ovarian stimulation is a key part of assisted reproductive     technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous     studies have evaluated the efficiency of the clinical approaches currently available.      Recent studies have shown that two natural compounds, such as inositol and melatonin, play an     important role in oocyte maturation and quality. Therefore, the present study aims at     investigating whether inositol and melatonin are able to improve the number of oocytes     obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH).      To this purpose, a randomized double-blind trial will be established where 150 healthy women     in reproductive age undergoing to assistant reproductive technology (ART) because of male     infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone,     group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin.      As primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical     pregnancy rate and live birth rate will be evaluated in group A vs. group B.   "
154037|NCT01267591|"     Background: The reactive hyperemia-peripheral artery tonometry (RH-PAT) is a newly developed     method for noninvasive endothelial function assessment.      Objective: The goal of this study is to determine whether a significant difference in RH-PAT     score is present between adolescents with type 1 diabetes (T1D) in comparison with controls.     We will also compare RH-PAT scores in obese adolescents versus controls.   "
154038|NCT01267578|"     The purpose of this study is to evaluate overall survival and immunological monitoring for     peptide vaccination therapy using novel cancer testis antigens (STF-II) for locally advanced,     recurrent, or metastatic esophageal squamous cell carcinoma   "
154039|NCT01267565|"     Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff     contribute to the constitution of VAP. The pepsin has been recently proved effective as a     surrogate of gastric content and was assessed in tracheal secretions. However, the pepsin     dosage is fastidious, expensive and only characterizes aspirations from gastric origin. The     aim of our study is to asses whether the value of amylase, which is mostly secreted by     salivary glands, may turn out to be a new and simpler surrogate for microaspirations in     ventilated ICU patients. Thirty patients ventilated for an anticipated length > 48h whose     endotracheal tube includes a subglottic secretion device and producing sufficient     endotracheal aspirations will be included. From H48, 4 sets of 3 aspirations each (oral,     subglottic, tracheal) will be performed during one ventilation day for amylase dosage     purpose. In ten of these patients, a comparison between pepsin and amylase will be assessed.     In addition, 10 non intubated patients with an indication to bronchoscopy and necessitating a     tracheal aspiration during the procedure will be included as a control group. The primary     assessment criteria will be the oral/tracheal amylase ratio.   "
154040|NCT01267552|"     To study the safety of not draining the axilla, after breast conserving surgery and full     axillary lymphadenectomy.   "
154041|NCT01267539|"     A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City     Hospital.Climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice     daily for four weeks.   "
154042|NCT01267526|"     This is a Canadian, Multicentre, Observational Registry to study Adherence and Long Term     Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth     hormone treatment from hospital and to assess the level of adherence of subject receiving     SAIZEN® via Easypod™ .   "
154056|NCT01267344|"     The primary objective is to investigate the objective response rate in patients receiving     GEMOX (gemcitabine plus oxaliplatin) plus cetuximab as first line treatment in advanced or     metastatic unresectable BTC biliary tract cancer compared to patients receiving the same     chemotherapy without cetuximab. The secondary objectives include the exploration of the     effect of the multimodality strategy on progression-free and overall survival, biomarker     prediction, and toxicity.   "
170540|NCT00069706|"     The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma     therapy in patients with open-angle glaucoma or ocular hypertension.   "
154043|NCT01267513|"     Ambulatory monitoring of physiological variables is important in following the health status     of individuals in non-hospital controlled situations. The investigators are developing a     non-invasive sensor based on dynamic light scattering that is able to measure pulse, blood     flow and coagulability. Oxygen saturation can also be detected with minor modification of the     apparatus. The investigators plan to validate the investigators sensor by applying it to     patients in the intensive care unit, or to patients undergoing cardiac stress tests. The     results of the investigators sensor will not be utilized for any therapeutic decisions, but     will be collected for later comparison with conventional monitoring of pulse and oxygenation     with standard monitors. The monitor is worn like a wrist watch, and will collect data into a     small data storage disc for later analysis.   "
154044|NCT01267500|"     Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help     in increasing control of strabismus   "
154045|NCT01267487|"     There are currently several schemes described for anticoagulation with heparin and its     reversal with protamine during cardiac surgery with CPB. The oldest, and most used in our     routine environment, is the scheme of fixed doses, in which a bolus dose of heparin at the     start of CPB is established in IU/kg of body weight and the dose of protamine at the end of     CPB is calculated based on the initial dose of heparin administered.      These schemes do not take into account the variability inter-patients and can result in     overdose or sub-doses of one or both drugs.      The titration schedule of doses of heparin and protamine through the principle of     dose-response curve of Bull promotes individualization of dosage according to the response of     each patient. This scheme has been associated with an effective reversal of the effect of     heparin after CPB and with reduction of post-operatory bleeding and transfusion.      The restoration of a state of anticoagulation by heparin after its reversal by protamine is     called rebound effect. It is a phenomenon explained by the recirculation of heparin stored     in the reticulum-endothelial system and connective tissue, or by free residual concentration     of heparin after clearance of protamine. This effect may be present for more than 6 hours of     post-operatory and may contribute to increase post-operatory bleeding.   "
154046|NCT01267474|"     The main objective was to evaluate the effect of a nutritional education program for school     lunch cooks, aiming to reduce added sugar in schools meals and in their sugar intake.   "
154047|NCT01267461|"     Recently the general medical literature has become aware that the use of certain long-acting     insulin analogues could potentially increase cancer risk.During the last few years the     investigators group generated information of both scientific and clinical relevance on the     proliferative and anti-apoptotic actions of insulin analogues. The goal of this project is to     evaluate the hypothesis that the proliferative and signalling activities elicited by insulin     analogues may have a impact on tumor behavior. In this study the investigators will asses the     biological actions of insulin analogs in primary tumor cells of endometrial and colon cancer.   "
154048|NCT01267448|"     Saxagliptin + Metformin XR (S+M) will be effective in stabilizing blood glucose (BG) levels     in patients with newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia (BG levels     300 to 450 mg/dl) and glucose toxicity and with no criteria for inpatient admission or     occurrence of severe hypoglycemia compared to glipizide XL.      The study may provide preliminary evidence to support the role of S+M as a bridging,     stabilizing and safe therapy in patients with severe hyperglycemia   "
154049|NCT01267435|"     The purpose of this study is to evaluate the accuracy of tunnel positions in anterior     cruciate ligament reconstruction   "
154050|NCT01267422|"     This study is meant to assess the safety and efficacy of rAAV2-ND4 treatment of Leber     hereditary optic neuropathy with 11778 LHON mutation.   "
154051|NCT01267409|"     Depressive symptoms of Parkinson's disease (PD) patients are major predictors of their     prognosis and quality of life. Using subthalamic nucleus (STN) deep brain stimulation (DBS)     as an antidepressant could be a promising new direction. Existing methods of adjustment of     DBS parameters aim at amelioration of the motor signs and therefore with inactivation of the     STN motor territory only. Although the DBS parameter setting is believed to influence the     mental state, there is no data that correlates stimulation parameters with mental state. The     investigators hypothesize that the emotional territories of the STN have distinct     electrophysiological properties and that specific stimulation of these emotional territories     can influence the mental state and thus treatment with emotionally-adjusted DBS can improve     the psychiatric symptoms of PD. In this project, the investigators intend to map the     emotional territories of the STN using neuronal (single units) responses to emotional voices     and to identify the emotional spectral signature of the STN single unit activity using     spectral analysis and neuronal responses to emotional voices. The investigators also intend     to investigate the emotional processing of PD patients by manipulating the stimulation of the     subthalamic area. The proposed study will combine neural recording, stimulation and     psychological tests to shed new light on emotional processing in the basal ganglia, as well     as to provide better treatment for PD emotional disorders,   "
154052|NCT01267396|"     The objective of this study was to compare and evaluate the single-dose oral bioavailability     of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr. Reddy's Laboratories     Limited) with the reference formulation ZOLOFT® 100 mg Tablet (Pfizer)under fasting     conditions in healthy adult human subjects.   "
154053|NCT01267383|"     The objective of this study was to compare and evaluate the single-dose oral bioavailability     of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr. Reddy's Laboratories     Limited) with the reference formulation ZOLOFT® 100 mg Tablet (Pfizer)under fed conditions in     healthy adult human subjects.   "
154054|NCT01267370|"     The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of     chronic constipation.   "
154055|NCT01267357|"     P16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma.     Evidence from previous trials indicates that it may be used as a diagnostic biomarker     distinguishing this disease from endometrioid endometrial cancer. Additional evidence points     to its prognostic value.      The current study will evaluate p16 both as a diagnostic tool for serous papillary     endometrial cancer and as a prognostic biomarker.      following anonymization, histology blocks will be microtomed and stained for P16 and P53     proteins.      Blocks from endometrioid endometrial cancer will be used as a control group.   "
154060|NCT01267292|"     Chronic cocaine use may produce disruption of neurotransmitter functions (including     dopamine). This may in turn contribute to measurable dysfunction in important cognitive and     behavioral processes. Stimulants that enhance dopamine (DA) function may help in treating     cocaine dependence and improving behavioral function -- supporting the notion that these     processes are related. An important step is to understand the subjective, physiological, and     behavioral effects of potential medications for cocaine dependence.      DA-modulating drugs may be targets for pharmacotherapy for substance dependence, and     particularly for stimulant drugs like cocaine, which disrupt normal DA function. Buspirone is     currently the only available dopamine subtype 3 (DA3) approved for human administration, and     is thus a viable investigational compound.      This project proposes to evaluate the DA-modulating effects of buspirone on behavioral     deficiencies related to DA depletion. Accordingly, the project aims to characterize the     effects of buspirone in individuals with cocaine dependence. Employing a daily dosing designs     within an acute stimulant challenge (methylphenidate), the experiment will characterize the     subjective effects, cardiovascular effects, and behavioral effects (attentional bias to drug     cues and risky decision making). The primary hypotheses are that buspirone will attenuate the     increases in subjective drug effects (stimulated, like drug) and behavioral effects     (increases in attentional bias and risky decision making) that are produced by acute     methylphenidate administration.   "
154061|NCT01267279|"     In a randomized, double-blind trial, BMD of the operated proximal femur after total hip     replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two     years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n =     24) at two weeks and one year after surgery.   "
154062|NCT01267266|"     This randomized phase II clinical trial is studying how well saracatinib works in treating     patients with prostate cancer. Saracatinib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
154063|NCT01267253|"     This phase II trial studies how well brivanib alaninate works in treating patients with     cervical cancer that has come back. Brivanib alaninate may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.   "
155062|NCT01254227|"     This study will evaluate the efficacy and safety of deferasirox in combination with     deferoxamine followed be deferasirox monotherapy in patients with severe iron overload due to     chronic blood transfusions.   "
154064|NCT01267240|"     This partially randomized phase II trial studies giving capecitabine and vorinostat in     treating patients with head and neck cancer that has come back after previous treatment or     that has spread to other areas in the body. Drugs used in chemotherapy, such as capecitabine,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth. It is not yet known whether giving capecitabine     together with vorinostat is more effective than capecitabine alone in treating patients with     cancer of the head and neck cancer.   "
154065|NCT01267227|"     Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries,     that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative     stress. The purpose of this study is to evaluate whether pterostilbene will help control     cholesterol and blood pressure, as well as improve markers for oxidative stress in patients     with dyslipidemia meeting inclusion criteria. The investigators also want to look at the     safety of pterostilbene in these patients.   "
154066|NCT01267214|"     The purpose of this study is to assess the efficacy and safety of Hyalgan after proximal     tibial osteotomy in treatment of knee osteoarthritis patients. Normally, OA patients who were     treated with osteotomy will not be treated with any SYSADOA after operation, even though     their cartilage's not completely loss, so osteotomy plus HA injection should provide more     benefit to patients than osteotomy alone.   "
154067|NCT01267201|"     A new formulation of methylprednisolone is being developed. A study is needed to determine     the drug availability using the new formulation, a powder for reconstitution into a     suspension, versus the current commercially available tablet formulation in healthy     volunteers.   "
154068|NCT01267188|"     The purpose of this study is to assess the safety and efficacy of three doses (12.5, 25, and     50 mg) of NBI-98854 for the treatment of the symptoms of tardive dyskinesia (TD) in subjects     with schizophrenia or schizoaffective disorder.   "
154069|NCT01267175|"     The user evaluation is to assess user acceptance and the quality of training materials for     the MiniMed Paradigm® X54 System (X54 System) in preparation for commercial distribution of     the new system.   "
154070|NCT01267162|"     This is a Phase IV, open-label, single-arm, 96 week community-based observational study     evaluating the antiviral efficacy, safety, and tolerability of TDF in HBV mono-infected     Asian-American adults who had completed 48 week treatment with Tenofovir in Gilead 174-0123     study. The primary objective of this study is to evaluate the long-term antiviral efficacy of     tenofovir DF 300 mg once daily in these patients. The secondary objectives are to evaluate     the safety and tolerability of TDF including the biochemical and virological responses to     TDF, the incidence of drug resistance mutations in these patients The duration of treatment     in this study is total of three Years (144 weeks) on TDF.   "
154071|NCT01267149|"     Statistical Hypotheses The Null Hypothesis: There is no difference in the reduction of lines     in the treated areas as compared to baseline.      Alternative Hypothesis: There is a difference in the reduction of lines in the treated areas     as compared to baseline.   "
154089|NCT01266915|"     Approximately 1.4 million individuals in the United States have systemic lupus erythematosus,     and about 85% of these individuals develop skin lesions at some point of their disease.     Cutaneous lupus erythematosus represents the skin manifestations of systemic lupus     erythematosus, and can appear in people with or without systemic lupus. It is a mentally,     physically, and emotionally debilitating disease that affects both the quality of life and     social well-being of those affected.      The cause of cutaneous lupus is not completely understood, but likely includes multiple     factors from our genes and the environment. Multiple genetic studies with small numbers of     cutaneous lupus patients have been performed to determine which genes are associated with     cutaneous lupus. This study aims to accumulate even larger numbers of patients to confidently     identify genes and the proteins they encode that could contribute greatly to the formation of     cutaneous lupus. The discovery of these genes and proteins would help not only uncover how     cutaneous lupus forms, but also improve our abilities to diagnose this disease and predict     its course, and stimulate new drug development.   "
154072|NCT01267136|"     Tonsillectomy is the most common pediatric surgical procedure performed in the US. The     postoperative period can be particularly painful. Codeine (usually in mixed formulation with     acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data     questions its ability to provide optimal pain relief, while avoiding side effects, especially     in the postoperative setting. Tramadol may be a better option for children in the     postoperative setting due to its well-documented analgesic properties, low potential for side     effects, and excellent safety profile. Seventy-two children scheduled to undergo     tonsillectomy (with or without adenoidectomy) at Children's will be invited to participate in     a randomized, prospective, double-blinded study to evaluate the efficacy and side effects of     codeine with acetaminophen versus tramadol. Using a 10-day take-home diary, caregivers will     be asked to record daily information about their child's postoperative pain and other core     outcomes and domains as recommended in the recent consensus statement put forth by the     Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials     (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the     efficacy and side effects associated with tramadol as compared with codeine/acetaminophen     (the current practice standard) in a pediatric population.      Hypotheses      H1: Children who receive scheduled tramadol following tonsillectomy will report better pain     control than children who receive scheduled codeine/acetaminophen.      H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side     effects than children who receive scheduled codeine/acetaminophen.   "
154073|NCT01267123|"     Colonoscopy is a procedure commonly performed to screen for colon cancer and to look for and     remove colon polyps. It involves inserting a flexible tube, equipped with a video-camera at     the tip, through the colon. The insertion process can be difficult in some patients,     resulting in an uncomfortable and lengthy procedure.We postulate that raising the foot of the     bed so that the stretcher forms a 15 degrees angle with the floor (Trendelenburg position)     may make the colonoscopy easier and more comfortable to the patient.   "
154110|NCT01266642|"     The goal of this clinical research study is to compare how 4 weeks of radiation treatment     affects the breast to how 6 weeks of radiation treatment affects the breast. Researchers also     want to know about other side effects of radiation.   "
154074|NCT01267110|"     Breast cancer is the second most common cause of cancer death in the U.S.1 in spite of being     preventable, easily detectable, and curable.2-11 Breast screening continues to be     underutilized by the general population and especially by traditionally underserved minority     populations. Two of the least screened minority groups are American Indians/Alaska Natives     (AI/AN) and Latinas. American Indian/Alaska Native women have the poorest recorded 5-year     cancer survival rates of any ethnic group and the lowest (or near-lowest) screening rates for     major cancers.12 Furthermore, breast cancer is the number one cause of cancer mortality among     Latina women.13 While breast cancer screening rates have increased nationally, there has been     an increase in the gap in breast cancer screening utilization between individuals from     minority versus majority racial/ethnic groups.   "
154075|NCT01267097|"     The Canadian pediatric obesity epidemic has led to great interest in evaluating weight     management care for obese children and families. Investigation is warranted since obesity is     linked to risk factors for chronic diseases including type 2 diabetes mellitus (T2DM) and     cardiovascular disease (CVD). Over the past 25 years, many interventions have studied the     role of healthy lifestyle behaviours to help obese children achieve and maintain a healthy     weight. A contemporary view of pediatric weight management interventions includes parents as     a fundamental recipient of treatment. These interventions recognize the influence parents     have on the lifestyle behaviours of their children. While such parent-based interventions     have helped establish the role of education and behavioural theory in facilitating lifestyle     changes, we believe an equally important intervention element is a focus on the role of     cognitions in helping to interpret behaviour change and change maintenance. Our study     incorporates cognitive behaviour theory (CBT) into an intervention for parents of obese     children and compares it to a more traditional modality based on psycho-education (PEP).      Hypothesis: Obese 8 - 12 year old children (n=45) whose parents complete a 16-session,     group-based, CBT intervention will achieve greater reductions in adiposity as well as     improvements in physiological risk factors for T2D, lifestyle behaviours, and psychosocial     outcomes at post-intervention as well as 6- and 12-months follow-up versus children (n=45)     whose parents complete a 16-session, group-based, psycho-education intervention .      Primary Objective: To compare the impact of two weight management interventions (CBT versus     PEP) for parents of obese children on child BMI z-score.      Secondary Objective: To measure a comprehensive set of physiological, behavioural and     psychosocial outcomes in obese children and parents pre- and post-intervention.      We expect obese children whose parents complete the CBT intervention will experience greater     reductions in BMI z-score vs. children whose parents complete the PEP intervention. We     anticipate that improvements in parenting style, family stress, and lifestyle behaviours will     be important to improve adiposity, lifestyle behaviours, and risk factors for T2DM and CVD in     obese children.   "
154076|NCT01267084|"     The purpose of this study is to evaluate the potential effects of ketoconazole on blood     levels of trabectedin after administration to patients with advanced malignancies.   "
154077|NCT01267071|"     The purpose of this study is to determine the absolute oral bioavailability and intravenous     pharmacokinetics of GSK962040. The oral dose of 50 mg has been selected because it was well     tolerated following single oral administration and it is considered to be within therapeutic     dose range. The need to characterize the intravenous disposition of GSK962040 is in     anticipation of drug use in special populations such as critically.   "
154078|NCT01267058|"     The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline     Biologicals' (formerly known as SmithKline Beecham Biologicals) combined     diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18 onwards,     in Australia.   "
154079|NCT01267045|"     This pilot study is a two arm randomized, controlled clinical trial that evaluated whether a     standardized Mindfulness-Based Stress Reduction (MBSR) intervention reduces symptoms     associated with Gulf War Syndrome (GWS) more effectively than treatment as usual. Fifty-five     veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to treatment as     usual (TAU) or TAU plus an 8-week course of course of MBSR. Study measures were collected at     baseline, immediate post-MBSR, and 6 months post intervention. Measures were obtained at     equivalent time points for veterans randomized to TAU only. Following completion of all study     activities, veterans randomized to TAU only had the opportunity to enroll in MBSR.   "
154080|NCT01267032|"     This project is designed to determine whether an efficacious behavioral intervention for     insomnia can improve the quit rates achieved by an efficacious smoking cessation program     aimed at PTSD patients (Integrated Care). A second aim is to deepen our understanding of     the mechanisms relating sleep and smoking in PTSD.   "
154090|NCT01266902|"     The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients     who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.   "
154091|NCT01266889|"     The aim of the study was investigated the cerebral tissue oxygenation index (c-TOI) measured     by near infrared spectroscopy (NIRS)in the preterm infants with intracranial haemorrhagia.   "
154092|NCT01266876|"     The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in     participants diagnosed with heterozygous familial hypercholesterolemia (heFH)   "
154081|NCT01267019|"     Veterans with schizophrenia and schizoaffective disorder experience high levels of disability     and poor community outcome, and these poor functional outcomes constitute a major public     health concern. The treatment of schizophrenia spectrum disorders has shifted fundamentally     from a focus on symptom reduction to a focus on recovery and improving aspects of     functioning. Needed improvements in community outcome for patients with these disorders will     not occur simply through better control of clinical symptoms. Instead, it is necessary to     find new treatments that address the key determinants of poor functional outcome, including     social cognition. Both basic (non-social) cognition and social cognition are considered key     determinants of functional outcome for schizophrenia and schizoaffective disorder. Basic     cognition includes the domains of: learning and memory, vigilance / attention, speed of     processing, reasoning and problem solving, and working memory. Social cognition generally     refers to mental operations that underlie social interactions, including perceiving,     interpreting, managing, and generating responses to socially relevant stimuli, including the     intentions and behaviors of others. As part of the investigators' previous Merit grant, they     have developed a training program for social cognition and are in the process of validating     it. Initial results suggest that the program improves performance on measures of social     cognition and functional capacity.      In this study, the investigators will evaluate whether adding an in vivo component (training     activities that occur in the community) to the current social cognition intervention     facilitates generalization of training effects to community outcome and subjective     satisfaction. Outcome measures of social cognition and functional capacity will be examined     during the 12 week training program, and durability of benefits will be assessed at a 3-month     follow up. Generalization to community functioning and subjective satisfaction will be     assessed at the end of training and at the 3-month follow up. The investigators will enroll     105 patients across the 5 years of the study with random assignment to training group (social     cognition intervention with in vivo exercises, social cognition intervention without in vivo     exercises and control). Subjects will receive assessments at baseline, 6 weeks (mid-point),     completion of training (12 weeks), and the 3-month follow up.   "
154082|NCT01267006|"     This study will invite two groups of volunteers to participate.      The data from one group of volunteers will be used to find out how much study drug, known as     GSK1325756, is in the blood after taking the drug twice in one day. Data will also collected     to find out if the level of cetain blood cells, known as neutrophils, change significantly     after taking the study drug twice in one day. This group of volunteers will be aged 40 to 64     years of age.      The data from the other group of volunteers will be used to find out if taking the study     drug, GSK1325756, twice in one day with or without food, makes a difference to the level of     study drug in the blood. This group of volunteers will also provide data to find out if any     study drug metabolites are present in the bile, a fluid secreted by the liver. This group of     volunteers will be aged 65 to 80 years of age.   "
154083|NCT01266993|"     The purpose of the study is to evaluate the persistence of the immune response of GSK134612     vaccine up to 68 months after vaccination in the primary vaccination study (NCT number =     NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and     immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary     vaccination study with either GSK134612 vaccine or Menjugate®.      This protocol posting deals with objectives & outcome measures of the persistence and booster     epochs. The objectives & outcome measures of the primary epoch are presented in a separate     protocol posting (NCT number = NCT00674583)   "
154084|NCT01266980|"     This study will assess the saftey of giving fluticasone furoate 200mcg/GW642444M 25mcg once     daily for 7 days to patients with severe renal imparement. The results of this study will aid     in deciding whether a FF/GW642444M doseadjustment is justified in subjects with severe renal     impairment and in estimating any such adjustments.   "
154085|NCT01266967|"     This study is designed to assess the efficacy, pharmacokinetics, safety, and tolerability of     an oral, twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or     V600K mutation-positive metastatic melanoma to the brain. Subjects in Cohort A will not have     received any local brain therapy, and subjects in Cohort B will have received prior local     therapy for brain metastases. Subjects will continue on treatment until disease progression,     death, or unacceptable adverse event.   "
154086|NCT01266954|"     The purpose of this study is to explore the potential dose response relationship between the     pharmacokinetics of GSK2141795 and [18F] FDG PET pharmacodynamic markers of glucose     metabolism in tumor tissue. Three to six subjects will be enrolled in each cohort and dosed     with repeat escalating doses of GSK2141795. [18F] FDG PET imaging and optional tumor biopsies     will be done prior to initiation of dosing and sequentially at select time points during the     first five weeks of dosing. The maximal dose of a given schedule evaluated in this study will     not exceed the maximal tolerated dose established in the first-time-in-human trial PCS112689     for the same schedule.   "
154087|NCT01266941|"     In relation to their severity, hepatic diseases can significantly modify drug absorption and     disposition and consequently can interfere with drug efficacy and/or produce toxicity. The     purpose of this study will be to aid in deciding whether a dose adjustment is required in     subjects with hepatic impairment and in estimating any such adjustments.   "
154088|NCT01266928|"     Preterm premature rupture of membranes (PPROM) is a complication affecting 3-4.5% of all     pregnancies. PPROM is the main known cause of preterm delivery and is associated worldwide     with increased rates of neonatal and maternal morbidity and mortality. Despite its frequency,     very little is known about its pathophysiologic mechanisms. Mechanical strength is provided     to fetal membranes by an extracellular collagen matrix. Types I, II, III and IV are the main     collagen types in these membranes. Studies have shown that total collagen content is reduced     in the amnion of women with preterm PROM.      Vitamin C is involved in the metabolism of collagen and has been proposed to play an     important role in the maintenance of the integrity of the chorioamniotic membranes. Vitamin E     may play a synergic role with vitamin C, increasing the antioxidant capacity against reactive     oxygen. Woods et al hypothesized that an increase in dietary consumption or supplementation     of vitamin C and E during pregnancy might reduce the risk of that portion of preterm PROM     that may be mediated by oxidative injury to fetal membranes. Plessinger et al report that     pretreatment of human amnion-chorion with vitamins C and E prevents hypochlorous acid-induced     membrane damage.      Borna et al. reported a randomized, double-blind controlled study of vitamin C and E     supplementation, in which women with preterm rupture of membranes and singleton gestations at     26 to 34 weeks were randomized to vitamin C and E supplementation or placebo. Supplementation     with vitamin C and E were associated with longer latency before delivery. However, the sample     size in this study was very small.      The aim of this study was to evaluate the effect of supplementation with vitamins C and E     after preterm premature rupture of membranes. We hypothesised that supplementation vitamins C     and E may be effective in decreasing oxidative stress and increasing the latency period.   "
154093|NCT01266863|"     To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram     analysis is required. E test strips have successfully provided an antibiogram 24 h after     having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective     cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with     the aim of validating a new method increasing the rapidity of antibiogram analysis compared     to standard methods of culture. This antibiogram will be provided by E test strips directly     applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour     after its completion. The occurrence of major errors (S with E test method, I or R with     standard method) and minor errors (I or R with E test method and S with standard method)will     be observed and a comparison of H6, H10 and H24 results performed.   "
157926|NCT01216774|"     The purpose of this study is to compare the impact of different levels of mechanical stress     and muscle fatigue in strength training conditions on muscle strength, muscle mass and     inflammatory processes.   "
154094|NCT01266850|"     Rotavirus, sometimes called the stomach flu, is the most common cause of severe diarrhea in     children. Vaccines can prevent many types of infections and work by causing the body to make     proteins called antibodies that fight infection. For some vaccines, more than one vaccination     is needed so that the body will make enough antibodies to fight infection. The vaccines     (RotaTeq® or Rotarix® oral vaccines) given in this study are recommended for infants by the     Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices     (ACIP). These vaccines require either 2 or 3 vaccinations to be effective. Healthy infants     between 6 weeks and 14 weeks, 6 days of age at Visit 1 will participate for about 10-12     months. Study procedures include reaction assessment and blood sample.   "
154095|NCT01266837|"     A single arm, open-label, multi-center phase IV clinical trial for patients with metastatic     renal cell carcinoma, who have progressed on or after the first VEGF-targeted therapy.   "
154096|NCT01266824|"     In this study, we will be evaluating whether premedication with an anesthetic eye drops leads     to a decreased sensation of pain when given dilating eye drops prior to eye examinations to     evaluate for retinopathy of prematurity in neonatal intensive care unit (NICU) infants.   "
154097|NCT01266811|"     The purpose of this study is to determine if there is an improvement in progression-free     survival (length of time during and after treatment in which a patient is living with a     disease that does not get worse) when siltuximab is added to VELCADE and dexamethasone in     subjects with relapsed or refractory multiple myeloma.   "
154111|NCT01266629|"     Capsule endoscopy (CE) is considered as a gold standard examination for small bowel Crohn's     disease. However, it is time-consuming, expensive and results are largely influenced by the     operator's skills. We, therefore, want to assess the predictive value of fecal calprotectin     and lactoferrin in patients undergoing CE.   "
155953|NCT01242514|"     The purpose of this study is to evaluate the long term safety and tolerability of     fostamatinib in patients with rheumatoid arthritis (RA).   "
154098|NCT01266798|"     Access to the best available evidence, and the ability to obtain and understand such     information is seen as necessary to protect the public's interests and critical to     empowerment, but is also a precondition for participation in the decision making.      A web portal serving as a generic (non disease- specific) tailored tool was developed in the     conceptual framework of shared decision making and evidence based practice to improve the     lay- public's critical and social literacy skills and activation. A randomized controlled     parallel trial using a simple randomization procedure will be conducted, including 200     parents of children <4 with internet access. Parents will be allocated to receive either the     portal or no intervention. Primary and secondary outcomes include: the ability to find     research based information, critical appraisal skills, perceived behavioural control,     attitudes and perceived pressure associated with searching for information, and     participation.   "
154099|NCT01266785|"     Crohn's disease is an inflammatory (swelling and soreness) disorder of the digestive tract.     Affected patients suffer from abdominal pains, diarrhea (sometimes bloody), weight loss. It     is a lifelong disease with frequent flares during the course of the disease. Crohn's disease     is mostly treated with medications, sometimes surgery is needed. Infliximab is a medication     for treating severe Crohn's disease. This medicine is effective by blocking special substance     (tumor necrosis factor) released from certain white blood cells in the body. Infliximab is     given via a vessel at week 0, 2, 6 initially, then every 2 monthly for maintenance. However,     some of patients with Crohn's disease do not respond infliximab. Currently there is no test     to reveal which patients will respond to treatment. This study aims to analyze and compare     particular subgroup of white cells and its products during and after infliximab treatment     which may determine the responsiveness to infliximab treatment.   "
154100|NCT01266772|"     This is 9 month, placebo-controlled, double blind, randomised trial using the oral     leucotrienes receptor antagonist montelukast (5 mg) in 160 children with mild and moderate     asthma age 6-14 year old, sensitive to house dust mite. There are two study groups:     montelukast group 80 patients and placebo group 80 patients. All patients will receive     budesonide in dose sufficient to control asthma symptoms and short-acting beta agonist as     needed. Medication used in the study: montelukast 5mg, budesonide. There are 7 doctor's     visits - one initial visit (June) and 6 follow-up visits. First visit is on the first day of     asthma symptom and each follow-up visit is every 6 weeks. Children with full asthma control     (as measured by exhaled NO) had administered 100 mcg lower dose of budesonide and children     with not fully control asthma had administered 100 mcg higher dose of budesonide.   "
154101|NCT01266759|"     To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral     Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age   "
154102|NCT01266746|"     The aim of this study is to determine the condition to detect the status of a macular hole by     spectral domain optical coherence tomography (SD-OCT) in gas-filled eyes. The macular area is     scanned by SD-OCT (OCT-4000, Carl Zeiss Meditec) in the patients who underwent vitreous     surgery for macular hole to detect macular jole closure on postoperative days 1, 3, 7, and     30.   "
154103|NCT01266733|"     The purpose of this study is to assess improvement in health related quality of life of     fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual     treatment.   "
154104|NCT01266720|"     The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with     gemcitabine in treating HLA-A*0201 restricted patient with non-resectable pancreatic cancer.   "
154105|NCT01266707|"     The purpose of this study is to assess toxicities of angiogenic peptide vaccine therapy in     treating HLA-A*2402 restricted patients with advanced hepatocellular carcinoma.   "
154106|NCT01266694|"     Background: The incidence of asymptomatic pericardial effusion is high after cardiac surgery.      Objective: To assess whether colchicine is effective in reducing post operative pericardial     effusion volume.      Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention :     colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac     rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate     to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by     echocardiography) more than 7 days after cardiac surgery.      Measurements: The main end point will be change in effusion grade after 14 days of treatment.     Secondary endpoints include frequency of late cardiac tamponade.   "
154157|NCT01266031|"     The goal of this Phase I portion of this clinical research study is to find the highest     tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with     malignant gliomas. The safety of these drug combinations will also be studied.      The goal of this Phase II part of this clinical research study is to learn if bevacizumab     when given with or without vorinostat can help to control malignant gliomas. The safety of     these drug combinations will also be studied.   "
154107|NCT01266681|"     Persistent Atrial Fibrillation (AF) is a common and distressing cardiac arrhythmia and     accounts for 1% of the healthcare budget in the UK and it's prevalence is rising. Symptoms of     atrial fibrillation include palpitations, chest pain , shortness of breath and fatigue, with     quality of life measures reduced for patients with persistent AF, increased stroke risk and     increased all cause mortality rates. DC Cardioversion is used to restore normal sinus rhythm     in patients with persistent AF. It has a high success rate but reoccurence of AF is common.     The use of anti arrhythmic drugs (AADs) can augment the number of patients remaining in sinus     rhythm at one year, with amiodarone currently the most superior. Unfortunately it can have     serious side affects. Dronedarone is a related drug designed specifically to minimise the     most serious side affects and is no approved and used prominently in the management of non     permanent AF. However it has not yet been studied in a post DC Cardioversion population.      Patients in persistent AF who are referred for elective DC Cardioversionwill be randomised to     receive either Amiodarone or Dronedarone to compare the ability to help maintain sinu rhythm     post cardioverion in one NHS hospital. Patients will be followed up for a year post     cardioversion to see if they stay in sinus rhythm.      Ho: there will be no difference in maintenance of sinus rhythm with the use of amiodarone or     dronedarone   "
154108|NCT01266668|"     The purpose of this study is to investigate the impact of rituximab in primary breast DLBCL     using a matched pair analysis following strict matching criteria in patients with primary     breast and nodal DLBCL treated with rituximab plus cyclophosphamide, doxorubicin,     vincristine, and prednisone (R-CHOP) regimen.   "
154112|NCT01266616|"     Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's natural     immune response. There are currently no FDA-approved therapeutic HIV vaccines. This study     will test whether giving an HIV-1 vaccine together with or without interleukin 12 (IL-12) is     safe and effective. This study will also test a new way of giving the vaccine called     electroporation (EP).   "
154113|NCT01266603|"     The goal of this clinical research study is to learn if high-dose interleukin-2 (HDIL-2),     when given in combination with recMAGE-A3 + AS15 ASCI (Antigen-Specific Cancer     Immunotherapeutic), can help to control unresectable or metastatic melanoma in patients whose     tumor tissue has the MAGE-A3 protein. The safety of this drug combination will also be     studied. Researchers will also use samples of the original tumor or metastatic tissue (for     example, lymph nodes or liver or lung) that are collected during screening to study if     response to the study drug is related to the genes in the tissue.   "
154114|NCT01266590|"     The purpose of this study is to determine how much digoxin gets into the blood stream and how     long it takes the body to get rid of it when given with LY2216684. Information about any side     effects that may occur will also be collected.   "
154115|NCT01266577|"     Background:      - Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of     the human body and evaluate activity in the brain. A particular MRI method called magnetic     resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help     researchers who are studying new treatments for psychiatric illnesses. Researchers are     interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS     techniques to view and measure brain chemicals and brain activity.      Objectives:      - To implement, develop, and optimize brain chemistry imaging techniques using magnetic     resonance imaging and magnetic resonance spectroscopy.      Eligibility:      - Healthy individuals between 18 and 65 years of age.      Design:        -  This study will involve a screening visit and a scanning visit at the National          Institutes of Health Clinical Center.        -  Participants will be screened with a full medical and physical examination, blood and          urine tests, and neurological testing.        -  During the second visit, participants will have an MRI scan of the brain. (Participants          who have received an MRI within the past year will not need to have a second one; the          images of the previous scan will be used for this study.) All participants will then          have an MRS scan using the same scanning equipment.   "
154116|NCT01266564|"     This observational study will assess the progression-free survival, overall response and     safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in     patients with metastatic colorectal cancer. Data will be collected from patients for     approximately 2 years.   "
154117|NCT01266551|"     What's known? Prone position is no longer a treatment option for GERD because of the     association with SIDS. Originally, positioning in an infant seat was recommended for infants     with GERD. However, Orenstein proved this position has a detrimental effect on GER, compared     to prone positioning.      What's new? Positioning in an infant seat caused no increase in GER, compared with the supine     15 degrees anti-Trendelenburg position. Except for the number of long reflux episodes, which     was significantly higher in the car safety seat. Larger trials are needed for decisive     conclusions.   "
154118|NCT01266538|"     This will be a comprehensive epidemiological, clinical, endoscopic and histological database     for inflammatory bowel diseases patients in our medical center that will further provide     clinical and basic investigations.   "
154227|NCT01265121|"     Sleep apnea is a common situation that affects up to 80% of acromegalic patients. This     disease is linked to disturbance on the carbohydrate metabolism increasing the rates of     diabetes. The objective of this trial is to assess (with the euglycemic hyperinsulinemic     clamp) the impact of the treatment of sleep apnea, with a continuous positive air pressure     device (CPAP), on the insulin resistance.   "
170541|NCT00069719|"     To determine the safety and IOP-lowering ability of a test compound in patients with     open-angle glaucoma or ocular hypertension.   "
154119|NCT01266525|"     Primary Objective:      - To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in     comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's     disease (AD) while on stable donepezil therapy      Secondary Objectives:        -  To explore the effect of SAR110894 on functional impairment, global clinical status and          behavioral disturbances;        -  To assess the safety/tolerability of SAR110894;        -  To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;        -  To explore caregiver time consumption and distress changes.   "
154120|NCT01266512|"     Primary Objective:        -  Response rate (by contrast CT scan)      Secondary Objectives:        -  Progression-free survival (PFS)        -  Overall survival (OS)   "
154121|NCT01266499|"     Klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen.     It is currently the fourth most common cause of pneumonia and fifth most common cause of     bacteremia in intensive care patients (1-3).      The aim of the present randomized controlled trial is to assess the efficacy of     non-absorbable oral antibiotics in the eradication of the KPC carrier state.   "
154135|NCT01266317|"     This is an open-label Phase I/II trial to assess the feasibility and safety of combined     plasma exchange (PEX), rituximab, and conventional corticosteroid administration on the     outcome of hospitalized patients with acute IPF exacerbations. The specific aims of this     study are:        1. To assess the feasibility and safety of combined PEX, rituximab, and conventional          corticosteroid administrations for the treatment of hospitalized patients with acute IPF          exacerbations by monitoring indices of respiratory (PaO2) and cardiovascular function          during the treatment interval.        2. To assess the efficacy of combined PEX, rituximab, and conventional corticosteroid          administrations for the treatment of hospitalized patients with acute IPF exacerbations          on patient survival in comparison to historical controls. Patient survival for this          investigation will be defined using the composite outcome of 60 day survival and/or          survival to lung transplantation.      Subjects between 18 and 80 years of age who have a confirmed diagnosis of IPF, and meet all     the study requirements will be enrolled in this study. A total of 10 subjects of both genders     and all ethnic backgrounds with acute IPF exacerbations hospitalized at UPMC will be enrolled     in this study.   "
155954|NCT01242501|"     This is a Phase IIB randomized trial to test a brief single session risk reduction counseling     intervention on HIV and STI behavioral outcomes in Cape Town South Africa.   "
154122|NCT01266486|"     Metformin, a drug that has been used since the 1950's in the treatment of diabetes, has     recently generated great interest in its anticancer effects based on in vitro, in vivo and     clinical studies. This study assesses the pharmacodynamic effects of metformin on breast     cancer metabolism.      The trial design is based on a 2 centre study 'Early Antiangiogenic Response to Bevacizumab     in Primary Breast Cancer' that is about to successfully complete recruitment in Oxford and     Mount Vernon hospitals. The study takes advantage of the 2 week window between the first     clinic visit and commencement of neoadjuvant chemotherapy. Metformin will be given to     patients for at least 2 weeks prior to neoadjuvant chemotherapy with a set of 3 breast core     biopsies, a PET-CT scan and blood tests carried out before and after this 2 week period of     treatment. Patients will also receive a drink of heavy (deuterated) water, a safe and stable     isotope commonly used in clinical lipid metabolism studies, the evening prior to both sets of     core biopsies. Having completed the first 2 weeks of metformin patients will have the option     of continuing metformin until completion of chemotherapy, at the discretion of the trial     physician.      The core biopsies will then be used to assess for changes in:        -  immunohistochemical staining;        -  gene profiles;        -  uptake of heavy water into tumour fatty acids using mass spectrometry techniques.      The aim is to identify potential biomarkers of response to metformin (and other future cancer     metabolism drugs).   "
154123|NCT01266473|"     The purpose of this study is to investigate individual efficacy in Physiotherapy for Airway     Clearance, and to investigate user experience, i.e.utility value and preference.   "
154124|NCT01266460|"     This phase II trial studies the side effects and how well vaccine therapy works in treating     patients with cervical cancer that does not go to remission despite treatment (persistent) or     has come back (recurrent). Vaccines therapy may help the body build an effective immune     response to kill tumor cells.   "
154125|NCT01266447|"     This phase II clinical trial is studying the how well veliparib, topotecan hydrochloride, and     filgrastim or pegfilgrastim work in treating patients with persistent or recurrent cervical     cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in     different ways to stop the growth of tumor cells, either by killing the cells or by blocking     them from dividing. Giving veliparib with chemotherapy may kill more tumor cells. Filgrastim     or pegfilgrastim may cause the body to make more blood cells and help it recover from the     side effects of chemotherapy.   "
154126|NCT01266434|"     To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a     signaling molecule for inflammation in inhaled steroid-treated asthmatics.   "
154127|NCT01266421|"     The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis     therapy and of other hormonal treatments for endometriosis.   "
154128|NCT01266408|"     The study compares the risks of short- and long-term use of contraceptives containing     drospirenone (DRSP) or dienogest (DNG)/ethinylestradiol (EE) plus levomefolate calcium     (metafolin) with the risks of short- and long-term use of other established oral     contraceptives (OCs).   "
154129|NCT01266395|"     Observational study to know the Impact of morning symptoms in clinical control of COPD     patients. 1200 patients will be included by General practitioners (GPs) and pneumologists.     Objective: establish if there are differences in the impact of COPD on daily activities and     morning symptoms measured through questionnaires of daily life activity (Capacity of Daily     Living during the Morning (CDLM), Global Chest Symptoms Questionnaire (GCSQ))   "
154130|NCT01266382|"     The purpose of the study is to examine the effect of a new biomechanical device and treatment     methodology (AposTherapy) on gait patterns, pain, function and quality of life of patients     with musculoskeletal and neurological disorders. Based on previous reports the investigators     hypothesis that this therapy will have a positive effect on these measurements.   "
154131|NCT01266369|"     The objective is to compare efficacy and safety of AB1010 at 3 or 6 mg/kg/day in treatment of     patients with mastocytosis with handicap and bearing activating point mutations in the     phosphotransferase domain of c-Kit such as the main mutation Asp-816-Val (D816V).   "
154132|NCT01266356|"     This integrated research project is cooperated by an fully-experienced team of Taipei Medical     University and National Institutes of Health. We hope that we can find out the disease of     balance, anxiety and sick headaches through the translation of basic research to clinical     diagnosis and treatment of Mild Traumatic Brain Injury (mTBI).   "
154133|NCT01266343|"     The investigators wanted to reported the results of immediate anterior chamber paracentesis     (ACP), compared to Mannitol infusion, in patients with acute primary angle-closure glaucoma     (PACG). In this study, the investigators first divided patients into three sub-groups     according to their initial intraocular pressure (IOP) for analyzing the differences of IOP     control, severity of corneal edema, waiting time for laser peripheral iridotomy (LPI), and     visual outcome between ACP and Mannitol infusion.   "
154246|NCT01263899|"     This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with     advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent     Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small     lymphocytic lymphoma).   "
154134|NCT01266330|"     Forty overweight and obese subjects (BMI 25-39.9) with metabolic syndrome will be randomized     to inadequate dairy (<0.5 serving/day) and adequate dairy (3.5 servings/day) weight     maintenance (eucaloric) diets for 12 weeks. Body weight will be measured weekly and body     composition (via dual X-ray absorptiometry), insulin sensitivity index, plasma lipids and     calcitrophic hormones will be measured at weeks 0, 4 and 12 of the dietary intervention.     Oxidative burden will be assessed by measurement of plasma malonaldehyde, 8-isoprostane F2α     and oxidized LDL and inflammatory stress will be assessed by measurement of IL-6, IL-15, MCP,     C-reactive protein, adiponectin and TNF-α levels in plasma at 0, 1, 4 and 12 weeks). An     additional global evaluation of diet-induced changes in cytokines will be conducted using     cytokine protein arrays to profile relative changes in 36 additional potentially relevant     cytokines. All data will be analyzed via two-factor (diet X obesity status) multivariate     analysis of variance (MANOVA)   "
154147|NCT01266161|"     The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide     analgesic efficacy superior to placebo over 12-hour dosing intervals.   "
154136|NCT01266304|"     The overall objective of this study is to develop and test an efficient self-report     instrument to measure Complementary and Alternative Medicine(CAM)-relevant contextual factors     important in healing.      The initial phase of the study involves developing and refining an item bank. During the     initial 'item bank development' phase, the investigators will run focus groups and cognitive     interviews with individuals who participate in CAM and conventional medicine interventions.      The current protocol in ClinicalTrials.gov pertains only to the initial phase of the study     involving focus groups and cognitive interviews.      The next step of instrument development is called Calibration, and will involve administering     the revised item bank to an internet sample and to persons who receive services in a CAM     clinic and a conventional primary care setting. The items will be calibrated using item     response theory and classical test theory. This will result in a computerized adaptive     testing version of the instrument, as well as a static short form of the instrument.      The final phase of the project will involve conducting initial validation studies of the     instrument. The instrument will be called the Healing Encounters and Attitudes List (HEAL).     The investigators will evaluate the convergent, discriminant, and predictive validity of the     HEAL in a sample of 200 persons with chronic low back pain who are receiving physical     therapy, chiropractic care, or mindfulness-based stress reduction. For convergent validity,     the HEAL is expected to display moderate to large correlations with measures of similar     constructs. The HEAL is expected to correlate modestly with self-report measures of general     psychosocial functioning, in support of discriminant validity. Finally, HEAL score should     account for a significant proportion of the variance in treatment outcome, supporting     predictive validity.   "
154137|NCT01266291|"     This is an open-label, phase 4 study to examine the safety and efficacy of vigabatrin     (Sabril) in Tuberous Sclerosis patients, a subset of the larger refractory complex partial     epilepsy population for which the drug is approved. While enrolled on this trial, subjects     will continue to take all of their normally prescribed medications, including their other     antiepileptic drugs (AEDs).      Alternatively, there is a prospective observational arm that subjects who are about to take     Sabril as treatment for seizures associated with Tuberous Sclerosis may join. Subjects who     join this arm will not have any study visits and will not be asked to do anything     specifically for the study. The study team will collect all study data from subjects' medical     records only.   "
154138|NCT01266278|"     Shoulder complaints are very common in overhead athletes.The application of kinesiotape that     keeps the shoulder in a correct position is used to avoid this.      This could enlarge the dynamic size of the subacromial space and thus contribute to     prevention of shoulder injuries.      30 young elite handball players will participate in this study.Researchers will perform a     number of measurements before and after applying kinesiotape to correct shoulder position:        -  measurement of subacromial space        -  measurement of 3D kinematics of shoulder        -  assessment of shoulder posture      Hypothesis of this study is that tape can influence the position of the scapula and is     therefore able to change the size of the subacromial space.This results in a more efficient     use of shoulder muscles with higher maximal strength as a result and maximizes shoulder     mobility.   "
154139|NCT01266265|"     A surveillance of respiratory tract related adverse events in patients treated with     Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies   "
154140|NCT01266252|"     Clinical experience with dexmedetomidine in the paediatric population is limited. Critical     illness can affect drug pharmacokinetics and -dynamics; the investigators cannot simply     extrapolate adult data for use in children but the investigators are in need of data on     pharmacokinetics and pharmacodynamics in every paediatric subpopulation.   "
154141|NCT01266239|"     In study-1, the purpose of this study is to compare the long-term outcome of provisional     stenting between EES and SES deployment. In study-2, it is to prove the following hypothesis      Asymmetrical expansion in the bifurcation lesion leads to frequent inhomogeneous intimal     growth on the strut and thrombus attachment.   "
154142|NCT01266226|"     The purpose of this study is to determine if autologous plasma (ACP) is beneficial for better     and faster healing following an arthroscopic repair of the rotator cuff.   "
154158|NCT01266018|"     This was a 2-arm, open-label, phase 2 study of pegylated arginine deiminase (ADI-PEG) 20 in     subjects with relapsed sensitive or refractory small cell lung cancer (SCLC). ADI-PEG 20 was     administered intramuscularly (IM) at a fixed dose of 320 IU/m^2 once weekly for a 4-week     cycle. The primary objective was to assess clinical efficacy with a primary endpoint of tumor     response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after 4 weeks.     Secondary objectives were to assess the safety, pharmacodynamics, and immunogenicity of     ADI-PEG 20, as well as clinical efficacy with a secondary endpoint of overall survival.   "
154159|NCT01266005|"     This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy     for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA     negative and ALT normal) will have follow-up period for additional 48 weeks.   "
154143|NCT01266213|"     Fulvestrant is an ER antagonist with no agonist effects, which binds, blocks and degrades the     ER. Fulvestrant is comparable to third-generation aromatase inhibitors in terms of efficacy     and tolerability for patients who have progressed on prior tamoxifen therapy and past studies     have found all three-third-generation AIs to be at least as good as tamoxifen in first-line     metastatic therapy in postmenopausal women. Fulvestrant has been studied little in     premenopausal women despite of its attractive mechanism of actions. The clinical     effectiveness of fulvestrant as a treatment for advanced breast cancer has previously been     demonstrated at the standard dose (AD; 250 mg/mo) in several phase III clinical trials in     postmenopausal women. However, there is evidence to suggest that doses of fulvestrant higher     than 250 mg may have greater pharmacodynamic activity against the ER pathway. Moreover,     dose-dependent clinical activity has been observed for fulvestrant. The activity of a     fulvestrant high-dose (HD; 500 mg/mo) regimen has been investigated in two recent studies. A     pilot Japanese study showed fulvestrant HD to have clinical activity in the treatment of     advanced or recurrent breast cancer, to be well tolerated, and to result in plasma levels     approximately double those seen with fulvestrant low-dose. Subsequently, a neoadjuvant study     comparing fulvestrant low-dose and high-dose reported that significantly greater Ki67 and ER     downregulation was achieved with the high-dose compared with the low-dose regimen and that     both doses were well tolerated. A recent randomized trial also showed superior outcome of     high-dose fulvestrant than AI.      Based on this rationale, we introduced high-dose fulvestrant with LHRH agonist as a     randomized trial comparing with AI plus LHRH agonist and LHRH alone in premenopausal     metastatic breast cancer patients who failed to tamoxifen treatment.   "
154144|NCT01266200|"     In this project, with unstable vertebral fractures, the microcirculation of the skin and     muscle (O2C,Laser-Doppler/White-light -Spectroscopy and contrast-enhanced sonography) will be     evaluated in both conventional and in percutaneous minimally invasive technique (XIA versus     Mantis) at the thoracolumbar junction.   "
154145|NCT01266187|"     Is a perioperative chemotherapy based on FOLFOX and Cetuximab (K-RAS wild-type) associated     with a higher rate of postoperative complications in patients with resectable colorectal     liver metastases as compared to only adjuvant FOLFOX and chemotherapy? Are there any     differences for disease free survival between periand postoperative treatment in patients     with >3 liver metastases or at least one metastasis > or = 5 cm in diameter?   "
154146|NCT01266174|"     The purpose of this study is to determine if eltoprazine (as an adjunct to anti-psychotic     medication) improves one or more aspects of cognitive impairment in adult schizophrenic     patients.   "
154148|NCT01266148|"     A controlled, randomized, open-label, multicenter study evaluating if early initiation of     everolimus and early elimination of cyclosporine in de novo heart transplant recipients can     improve long-term renal function and slow down the progression of chronic allograft     vasculopathy   "
154149|NCT01266135|"     This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of     QAX576 in patients with idiopathic pulmonary fibrosis.   "
154150|NCT01266122|"     This study will develop and pilot test a combined individual and group-level behavioral HIV     prevention intervention for men who have sex with men (MSM) in Chennai, India, addressing HIV     risk within the context of broader psychosocial issues, including self-acceptance, substance     use and social support.   "
154151|NCT01266109|"     Juvenile drug courts were developed in response to a perceived need to intervene more     effectively with youth with substance abuse problems. Close collaboration between the court     and substance abuse treatment provider is a defining component of the drug court model and is     critical to helping youth achieve positive outcomes. Despite the proliferation of juvenile     drug courts in recent years, however, evaluation of their capacity to reduce offender     substance use and criminal activity has lagged. Moreover, the Institute of Medicine (IOM,     1998) and leading experts (McLellan, Carise, & Kleber, 2003) have presented a bleak picture     of the nation's capacity to meet the treatment needs of substance abusing individuals.     Although community-based programs provide the backbone of substance abuse treatment in the     nation, their capabilities have not kept up with major scientific advances in the development     and validation of evidence-based substance abuse interventions.      Building on our research findings and experience regarding juvenile drug court outcomes as     well as the transport of evidence-based practices to community treatment settings, the     purpose of this study is to develop and test a relatively flexible and low cost strategy for     enhancing the outcomes of juvenile drug courts by integrating components of evidence-based     treatments into existing substance abuse services.      Specifically, this project aims to:      Aim 1: Adapt existing intervention and training protocols from evidence-based practices     (i.e., Contingency Management for adolescent substance abuse; family engagement strategies     from evidence-based treatments of juvenile offenders) for integration into juvenile drug     court sites.      Aim 2: Conduct a study to examine youth (e.g., substance use and criminal behavior) and     system level (e.g., intervention adherence, feasibility, retention and completion rates,     consumer satisfaction, cost estimates) effects of implementing the intervention protocols in     juvenile drug courts.      Aim 3: Revise the intervention and training protocols in preparation for a Stage II study if     findings are supportive.   "
154152|NCT01266096|"     Current tests to detect cancer, including CAT scans and MRI scans, are limited. PET scans use     special dyes that are injected into a vein and can better localize possible cancer. The     investigators have developed a new particle that can carry a radioactive dye to a very     specific area of the tumor. When using a PET scan the radioactive dye can be viewed in areas     of possible disease. This particle has been studied in mice and was safe.      The particles will not treat the cancer and any images or information found during this study     will not be used for your treatment. The information collected may be used to guide the     design of future studies to detect and/or treat tumors.   "
154153|NCT01266083|"     The purpose of this study is to determine whether the WT1 vaccine causes an immune response     which is safe and able to keep the leukemia from coming back. While vaccines have been used     in infectious diseases like smallpox and measles,the idea about using vaccines in a cancer     like AML/ALL is really a new use of the idea of vaccines.The WT-1 vaccine is made up of     protein pieces that the immune system can recognize as abnormal. The doctor thinks that the     WT-1 protein is important in AML/ALL and using some lab tests they are still able to find     some of it in the bone marrow. By attacking this small amount of the protein they hope to get     rid of any small amount of AML that is still in the body.   "
154154|NCT01266070|"     The goal of this clinical research study is to learn if dovitinib can safely be given to     patients who have VHL with a measurable hemangioblastoma (tumor of the central nervous     system). The effects of this drug on the disease will also be studied.   "
154155|NCT01266057|"     The goal of this clinical research study is to find the highest tolerable dose of sirolimus     or vorinostat that can be given in combination with hydroxychloroquine to patients with     advanced cancer. The safety of these drug combinations will also be studied.   "
154156|NCT01266044|"     The goal of this clinical research study is to learn if acupuncture can help to prevent     xerostomia (dry mouth) and improve the quality of life in patients who receive radiation     treatment to the head and neck. This study will determine if one acupuncture treatment     approach is more effective than another. Dry mouth is a common problem among cancer patients     who have received radiation treatment to the head and neck.   "
168005|NCT00038649|"     The goal of this clinical research study is to see if higher doses of imatinib mesylate     (Gleevec, STI571) can improve chronic myelogenous leukemia (CML) in chronic phase.   "
154160|NCT01265992|"     Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for     the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 & 4     Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the     effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in     Sweden.      This observational study is designed to collect data to evaluate safety and effectiveness     during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD Stages     3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs     associated with patient care.   "
154161|NCT01265979|"     The purpose of this study is to evaluate WB DWI as early predictor of response to treatment     with regorafenib or placebo in patients with advanced metastatic GIST.   "
154162|NCT01265966|"     Currently, it is unknown whether sedation itself induces a rise in serum cortisol levels or     if cortisol levels rise under only the most invasive of procedures, regardless of the type of     anesthetic agent used. Animal data shows significant alterations in steroid intermediates     under anesthesia regardless of the procedure performed. Prior studies in children show     general anesthesia and even epidural anesthesia can cause a rise in serum cortisol, but the     effects of moderate and deep sedation on cortisol levels during different types of procedures     are unknown. General medical practice varies considerably among providers; some provide     stress dosing (extra and sometimes high doses of steroids) for sedation for both non-invasive     and invasive procedures for patients with known adrenal insufficiency, but the doses given     vary considerably. Others provide stress dosing only for the most invasive procedures in this     population of patients. Currently there is no published normative data on changes in cortisol     levels under moderate and deep sedation in adrenally sufficient children, so the normal     response we are trying to mimic is unknown.      We propose to measure salivary cortisol levels prospectively in adrenally sufficient children     undergoing moderate and deep sedation to determine the normal cortisol response to the stress     of sedation for both invasive and non-invasive procedures.      Up to 300 adrenally sufficient children will be prospectively recruited to measure salivary     cortisol levels during moderate and deep sedation for non-invasive procedures (e.g. MRI,     echocardiogram, or other imaging studies), and invasive procedures (e.g. surgery, endoscopy)     to determine what the normal cortisol response is to the stress of sedation during these     procedures using various anesthetic agents.      The primary outcome variable will be to determine peak salivary cortisol measurements during     non-invasive and invasive procedures under different levels of sedation using various     anesthetic agents, and correlate these with known norms in children to determine if the     patient's hypothalamic-pituitary-adrenal axis is under stress.   "
154163|NCT01265953|"     The objective of the study is to identify mechanisms by which compounds found in cruciferous     vegetables alter gene expression via epigenetic modifications (changes in gene expression)     and may prevent prostate cancer development.      The investigators have found that sulforaphane (SFN), an isothiocyanate found in cruciferous     vegetables, inhibits histone deacetylase (HDAC) activity in human colorectal and prostate     cancer cells.   "
154164|NCT01265940|"     Urothelial carcinoma of the bladder mostly is chemically induced and represents the second     prevalent urooncological disease. About 20% of newly diagnosed urothelial carcinoma cases of     the bladder are already advanced or metastasized. Before 2008 2009 no second line therapy     after failure of primary systemic therapy of advanced / metastatic disease was established     outside of clinical trials. The actual standard for this situation was a supportive,     symptomatic therapy. Vinflunine has demonstrated improved survival from 4.3 to 6.9 months     (p=0.04), with an adequate disease control, good symptom control and with acceptable     toxicity. Based on these results, this compound became standard se¬cond line treatment for     refractory metastatic bladder cancer disease after failure of platinum-containing therapy. As     the prognosis still remains poor, new treatment opportunities have to be explored.      The target-specific therapy with Pazopanib suggests a positive influence of both inductive     and perioperative treatment of solid tumors. Pazopanib has been approved by the FDA and the     EMA for the treatment of advance renal cell carcinoma. Results for advanced urothelial     carcinoma are missing so far as well as data on tolerability of the combination of both     vinflunine and pazopanib. As the pharmacodynamic properties as well as the safety profile of     both drugs are different, assumption is justified that there might occur additive efficacy     effects without addition of adverse outcomes. Aim of the study thus is        1. To define the maximum tolerated dose (MTD) of Pazopanib in combination with Vinflunine          in a phase-I-setting and        2. To further assess efficacy and safety of the combination at the MTD level in phase II.      During the pase-I-part of the study different doses of pazopanib will be added to the     standard vinflunine scheme in groups of 6 patients maximum. Dose escalation will only be     performed in the next patient group if not more than one out of six patients shows     dose-limiting toxicity. Each patient will be treated with the drug combination for a duration     of two vinflunine cycles, that is six weeks.      During the phase-II study new patients will be treated with the drug combination at     maximum-tolerated dose until disease progression (assessed by RECIST 1.1 procedures).   "
154165|NCT01265927|"     A study to evaluate safety and biologic effects of giving GRN163L in combination with     trastuzumab in patients diagnosed with HER2+ metastatic breast cancer that is resistant to     therapy with trastuzumab.   "
154166|NCT01265914|"     The purpose of this study is to investigate the safety, tolerability and immunogenicity of     ascending doses of a novel, universal flu vaccine, in healthy volunteers.   "
154167|NCT01265901|"     The primary objective of the phase III study is to investigate whether IMA901 can prolong     overall survival in patients with metastatic and/or locally advanced renal cell carcinoma     (RCC) when added to standard first-line therapy with sunitinib.      Secondary objectives include a subgroup analysis of overall survival in patients defined by a     certain biomarker signature, the investigation of progression-free survival, best tumor     response, safety, and immunological parameters.   "
154168|NCT01265888|"     A Phase 2 open label, dose escalation study to find the minimally and maximum effective dose     (dose beyond which no further effect on PVR is seen) of inhaled nitric oxide generated by the     GeNOsyl® System compared to placebo.   "
154169|NCT01265875|"     -  To determine if intravenous secretin administration in escalating doses three times          daily for three days will improve the pain from CP at the time of infusion, after each          infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.        -  To validate the safety of intravenous secretin administration at the dosage indicated in          this study.   "
154170|NCT01265862|"     The investigators aim to compare two different types of supraglottic devices for tracheal     intubation in patients undergoing elective surgery under general anesthesia.      The investigators hypothesis is that the use of the I-gel® supraglottic airway device     associated with a GlideRite® endotracheal tube will result in an equal success rate of     fiberoptic tracheal intubation when compared to the LMA-Fastrach® associated with a     GlideRite® endotracheal tube. Time to intubate with the I-gel® device should also be shorter.   "
154171|NCT01265849|"     The purpose of this study is to determine whether LI administered in combination with     cyclophosphamide, indomethacin and zinc (CIZ) in a multivitamin combination prior to standard     of care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy) is safe     and will increase the overall survival of subjects with previously untreated squamous cell     carcinoma of the oral cavity or soft palate at a median of 3 years   "
154172|NCT01265836|"     The purpose of this study is to establish the proportion of patients on lipid-lowering     pharmacological treatment (statin or combination) reaching the LDL-C goals according to the     updated 2004 National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III)     guidelines.   "
154173|NCT01265823|"     W11-050 is a Mexican open label multicenter study that has been designed to further assess     the safety and efficacy of adalimumab in the treatment of patients with active plaque     psoriasis who have failed prior conventional systemic psoriasis treatment or who are     candidates for systemic therapy.   "
154174|NCT01265810|"     Targeted therapies such as multi-targeted tyrosine kinase inhibitors (TKI) and mammalian     target of rapamycin inhibitors (mTORI) in renal cell carcinoma (RCC), demonstrate a high     level of efficacy with acceptable tolerability. Currently, there are five approved targeted     therapies available for RCC: sunitinib (Sutent®), sorafenib (Nexavar®), pazopanib     (Votrient®), temsirolimus (Torisel®), and everolimus (Afinitor®). Hepatocellular carcinoma     treated with sorafenib and gastro intestinal stromal tumors patients treated with sunitinib     will be included, too.      Since this agents have dermatological adverse events in common, with oral mucositis (OM),     hand-foot skin reaction (HFSR) and papulopustular eruption (PPE) as an disabling side effect,     we require evidence based management options to prevent and treat these adverse events. The     incidence of OM of any grade is for sunitinib 38%, sorafenib 28%, pazopanib 4%, temsirolimus     41%, and everolimus 44%. Recent data suggest that TKI and mTORI associated OM is distinct     from conventional mucositis and more closely resembles aphthous OM.      Recently, supersaturated calcium-phosphate rinse (Caphosol®), a Ca2+/PO43- mouth rinse,     became available to prevent or treat OM.      The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes     which include oral intake, swallowing function and pain associated with incidence of grade ≥     1 oral side effects and the anticancer therapy cessation in patients treated with selected     targeted anticancer therapy.      Patients with OM > grade 0 on targeted therapy will be randomly allocated to receive either     Caphosol® or NaCl 0.9% rinse for two weeks. After the first rinse period all patients will     switch to the opposite treatment arm (NaCl 0.9% or Caphosol®) for another two weeks. Duration     of oral side effects, severity, pain, dose of analgesics and tolerability will be assessed     weekly with the VHNSS oral-specific questionnaire. Patients will be stratified by targeted     anticancer agent and per tumor type (pre-defined cohorts). Objective severity of oral side     effects will be assessed using the NCI-CTCAE v4.0. Correlation of subjective VHNSS scores     with the objective NCI-CTCAE grade, sex, age, targeted therapy type, and cancer type will be     conducted.   "
154175|NCT01265797|"     Cranial electrotherapy stimulation (CES) may be a safe adjunct to medical treatment for pain     relief in migraine patients. However, despite the number of CES studies done, many have been     open label, single blinded, or have utilized a small group of patients.   "
154176|NCT01265784|"     This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to     assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared     with ertapenem in the treatment of adult community-acquired complicated intra-abdominal     infections (cIAIs).   "
154177|NCT01265771|"     The purpose of this study is to assess efficacy of prolonged Full Disclosure     electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology     to diagnose arrhythmia in comparison with standard diagnostic procedure.   "
154178|NCT01265758|"     The purpose of this study is to assess efficacy of prolonged Full Disclosure     electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology     in comparison with a standard Holter ECG recording and an Event Holter recording to diagnose     cardiac arrhythmia.   "
154179|NCT01265745|"     Valortim is the name of the experimental drug that volunteers will receive in this study.     Valortim may also be called MDX-1303. Experimental means that the drug is not yet approved by     the Food and Drug Administration (FDA). Valortim is a monoclonal antibody (laboratory-made     immune system molecule) for the treatment of inhalation anthrax (when the infection starts in     the lungs). Valortim works by attaching itself to part of the anthrax toxin preventing the     toxin from doing damage to cells. This study is being conducted to see if Valortim given over     120 minutes is safe and tolerable. This study will take place in five parts: Screening Phase,     Check-in Phase (the day you arrive at Quintiles to start the study), Treatment Phase (the     time when you receive the study medication), Follow-up Phase (the time after you receive the     study medication) and Final Visit.   "
154180|NCT01265732|"     This study investigates the safety, tolerability and pharmacokinetics of PF-04191834 when     respectively given orally as a single dispersion dose and a single dose of a suspension. The     suspension is the test formulation and the dispersion is the formulation with which the novel     preparation will be compared.   "
154181|NCT01265719|"     This is a non-interventional, prospective, longitudinal cohort study. A total of 150     pediatric subjects with glaucoma or elevated intraocular pressure, including 75     latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will     be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a     non-interventional study, the study subjects' continued use of latanoprost and assessments of     ocular events will be obtained through the routine medical follow-up with treating     ophthalmologists or other designated members of the medical care team.   "
154182|NCT01265706|"     This study is performed to observe the incidence of major cardiovascular events in Korean     patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year.   "
154183|NCT01265693|"     The aim of the study is to assess the effect of antiviral therapy with pegylated interferon     alpha for hepatitis C and B on auditory disability as there are reports in the English     literature on auditory disability caused by interferon alpha.   "
154184|NCT01265680|"     All patients operated on at the European Hospital Heart surgery Division will be randomized     to either single dose 80.000 UI of Human Recombinant Erythropoietin and intravenous iron or     control.      Primary end point is the amount of transfused blood. Secondary end point is the Hemoglobin     level in the patient on postoperative day four.      Ancillary analysis regarding safety at 45 days and cost effectiveness are planned as well   "
154185|NCT01265667|"     Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16     weeks. All subjects will receive open-lable CF101 in weeks 17-32.   "
154186|NCT01265654|"     Breast cancer is the leading type of cancer in women. Although big advance in diagnostics and     treatment of early and breast cancer has been made in recent years breast cancer still has a     significant mortality rate. A number of treatment modalities exist for postmenopausal women     with advanced breast cancer. The treatment modality is chosen based on patient and tumour     characteristics. Hormonal treatment is preferred and recommended in women with hormone     sensitive breast cancer (ESMO, CECOG and NCCN guidelines). Tumor markers are an established     method of monitoring systemic therapies in various cancers. Tumor markers CA 15-3 and CEA are     used in clinical practice to monitor treatment efficacy of metastatic breast cancer. Blood     levels of tumor markers are widely used to assess response/progression to treatment and guide     therapy change. Treatment efficacy is assessed by imaging methods in clinical studies. Change     of therapy in clinical study is usually done when progression based on RECIST criteria is     found. Hormonal treatment has slower onset of effect compared with chemotherapy that can last     several weeks. Also when a new therapy is started spurious early rises may occur. Therefore     rising levels of tumor markers during the first weeks of new hormonal therapy are not     necessarily sign of progression and should not be the only guidance for treatment change.     Evidence of treatment efficacy form clinical studies and treatment change is based on imaging     techniques.   "
154187|NCT01265641|"     The purpose of this research study is to evaluate the effect of AZD1981 on the electrical     activity of the heart, in particular when the heart muscle is relaxed during a heart beat     cycle. The effect of AZD1981 will be compared to a licensed antibiotic (moxifloxacin) which     is well known to affect the electrical activity of the heart, but this effect is known to be     at levels that are safe at the dose used in this study. The investigators will also compare     the effects of AZD1981 with a dummy drug (placebo). The investigators will also be     evaluating how safe and well tolerated AZD1981 is and how much AZD1981 enters the blood     circulation by collecting blood during the study.   "
154188|NCT01265628|"     Comparison of the differential luminance sensitivity (DLS) values at each test point   "
154189|NCT01265615|"     We hypothesize that paricalcitol and calcitriol in dose-dependent manner are effective for     the management of chronic allograft dysfunction (CAD), protection and repair of kidney and     heart, management of chronic renocardiac syndrome (CRS). We assume that paricalcitol can have     some advantages if compare with calcitriol or cholecalciferol due to absence of calcemic and     phosphatemic complications alongside with great beneficial potential.   "
154190|NCT01265602|"     The aim of this study is to determine the efficacy, safety and tolerability of LAS41007     compared to a marketed reference product as well as to vehicle (topical application, twice     daily, indication mild to moderate AK).   "
154191|NCT01265589|"     To research the effect of vitamin A to newborn respiratory distress syndrome by intratracheal     administration with surfactant.   "
154192|NCT01265576|"     The purpose of this study is to determine if VT-122 provides a clinical benefit when added to     Sorafenib in patients with advanced hepatocellular carcinoma (HCC).   "
154193|NCT01265563|"     The study is done to find out whether the combined use of the nutritional supplements     N-acetylcysteine and Siliphos (milk thistle extract) corrects the shedding of urine protein     and oxidative damage (damage to cells and organs often compared to fast aging) in patients     with Type 2 Diabetes Mellitus (T2DM) and diabetic kidney disease.   "
154194|NCT01265550|"     Background: Gastroesophageal reflux disease (GERD), which affects at least 20% of adult     Americans, may be especially common and severe in Veteran patients. Proton pump inhibitors     (PPIs), which block gastric acid production, are the most effective medications for GERD, and     the VA spends more than $177 million each year on outpatient PPI prescriptions. PPIs do not     prevent the reflux of non-acidic material and do not completely eliminate esophageal acid     exposure, however, and bothersome GERD symptoms persist in approximately 40% of patients     treated with PPIs. Recent studies using the new technique of esophageal pH/ impedance     monitoring, which detects the reflux of both acidic and non-acidic materials, have shown that     PPI-resistant GERD symptoms correlate with episodes of reflux (acidic and/or non-acidic) in     approximately one-half of patients. For those patients, an antireflux operation might relieve     symptoms and obviate the expense of ineffective PPI therapy, but the efficacy of modern,     laparoscopic fundoplication in this regard is not clear. For patients with PPI-resistant GERD     symptoms, furthermore, the efficacy of medications that that can prevent gastroesophageal     reflux (e.g. baclofen) or diminish pain of esophageal origin (e.g. neurotropic agents like     desipramine) also is not clear. Study Hypothesis: Laparoscopic antireflux surgery (Nissen     fundoplication) is superior to medical therapy (PPIs plus baclofen and desipramine) for GERD     patients who, while on PPIs, have persistent episodes of heartburn that are associated with     reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance     monitoring.      Study Goals: The primary goal is to compare the efficacy of laparoscopic Nissen     fundoplication and medical therapy (PPIs plus baclofen and desipramine) for GERD patients     who, while on PPIs, have persistent episodes of heartburn that are associated with reflux     episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring, and     to compare the efficacy of each therapy with placebo. Secondary goals are: 1) To determine     the frequency with which non-GERD disorders underlie PPI failure, 2) To determine the     frequency of functional gastrointestinal symptoms, anxiety and depression in patients who     have persistent heartburn while on PPIs, 3) To determine whether functional gastrointestinal     symptoms, anxiety and depression is associated with the outcomes of medical and surgical     therapies, and 4) To determine whether the outcome of Nissen fundoplication is associated     with adherence to technical aspects of the operation.      Study Design: At 15 VA medical centers, there will be a 30-month recruitment period to enroll     393 patients with heartburn that is refractory to PPI therapy. Patients will have their     baseline GERD symptoms scored using the GERD Health-Related Quality of Life (GERD-HRQL)     index, and will have endoscopy, esophageal manometry and esophageal pH/impedance monitoring     while on PPI therapy. Patients who have episodes of heartburn that are associated with reflux     episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring will     be randomized to one of three treatment groups: Surgical Treatment (laparoscopic Nissen     fundoplication), Active Medical Treatment (omeprazole and baclofen initially; desipramine for     baclofen failures) or Placebo Medical Treatment (omeprazole, placebo baclofen, placebo     desipramine). All patients will have quarterly clinic visits for symptom scoring and     laboratory testing. At one year, patients will have a final symptom scoring and repeat     endoscopy, esophageal manometry and esophageal pH/impedance monitoring. Treatment success     will be defined as 50% improvement in the GERD-HRQL score at 12 months. Patients also will     complete the Hospital Anxiety and Depression Scale (HADS), Rome III Functional GI Disorders     Questionnaire and the Short-Form Health Survey (SF-36) at baseline and one year. The results     will be correlated with treatment outcomes.   "
154195|NCT01265537|"     While the incidence of acute rejection and early graft loss have improved dramatically with     the advent of newer immunosuppressant medications, improvements in long-term patient and     allograft survival after kidney transplantation have not been achieved. The specific drug     combination that provides the best outcomes with the least amount of side effects is not     known. Each kidney transplant center uses the combination of drugs that they believe is     optimal. This study is about identifying whether drugs that are currently approved for use in     kidney transplantation can be used in a new combination safely and with potentially fewer     side effects than the drug combinations that are currently used at St. Paul's Hospital and     other transplant centres.   "
154196|NCT01265524|"     The purpose of this study is to determine the effects of CLP on serum potassium and signs and     symptoms of fluid overload in heart failure patients with chronic kidney disease.   "
154197|NCT01265511|"     This study will examine the effectiveness of 28 days of triple combination therapy including     SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An     additional 20 weeks of treatment with the currently approved standard of care will be offered     to all participants. The Week 24 visit will be the last on-study visit. After the Week 24     visit, all subjects with undetectable HCV RNA will be given the option to continue treatment     with standard of care for an additional 24 weeks (out to Week 48) under the care of their     Principal Investigator.   "
154198|NCT01265498|"     Administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks     to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in     improvement in their liver disease as measured by changes in the nonalcoholic fatty liver     disease (NAFLD) activity score (NAS).   "
154199|NCT01265485|"     This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be     participating in this study. This study is composed of 2 parts:      Part 1 is a dose finding study. Part 2 is a pharmacodynamic and pharmacokinetic study of an     elected dose. A screening will be used to determine patients' suitability for inclusion in     the trial. Within one week after the screening visit, subjects who meet all inclusion     criteria and none of the exclusion criteria will enter part 1 of the study, one day of dose     escalation. During this part, patients will undergo rectal manometry to determine anal     pressure at baseline. Afterwards coated suppositories at various drug concentrations will be     inserted and follow up manometries will be performed to determine response.      Patients that presented with an increase in rectal resting pressure without adverse events     will enter the second part of the study. In this part, patients will be administered with a     coated suppository, at a dose found at part 1 of the study to cause significant anal     contraction. Manometry studies will be performed before insertion (baseline) and at 1, 3 and     5 hours after insertion.      Blood levels for drug concentrations will be taken at times 0, 30, 60, 120, 180, 300 minutes     after administration and rectal manometries will be done at times 0, 1, 3 and 5 hours after     administration.   "
154200|NCT01265472|"     Translocator protein (TSPO) is a intracellular protein that is found primarily in the outer     membrane of the mitochondria that is encoded by the TSPO gene. It has been found that TSPO     expression in the skin correlates with cell proliferation and differentiation. Many studies     have shown that TSPO overexpression in solid malignancies such as in ovarian cancer, colon     cancer, and others, was also found to correlate with more aggressive cancer behavior. Working     Hypothesis and Aims: Previous studies described an aberrant expression of TSPO levels in     solid malignancies as compared to normal tissues. It is assumed that this aberration can be     found in cuntaneous malignancies as well. The occurrence of this aberration may lead to the     understanding of the mechanism of TSPO involment in the cutaneous malignancy, and in     malignancies in general. Methods: The study will be carried out on surgically resected skin     lesions suspected to SCC or BCC, which will be removed as part of the surgical routine     treatment. The excision will be made in elliptic shape including the lesion and a part of     normal skin surrounding it. A sample will be taken from the central part of the lesion and     from the external extremity of the normal tissue. Western Blot will be conducted to detect     the expression of TSPO. Binding activity with the TSPO specific ligandwill also be     determined. Expected Results: We expect to observe either (a) a higher level of TSPO     expression and a lower binding activity in malignant tissue compared with healthy control     tissue or (b) a higher level of TSPO expression and a lower binding activity in malignant     tissue compared with healthy control tissue. Importance: Until today, only a very small     number of studies have examined TSPO in cutaneous malignancies, and these only examined TSPO     expression. Our study will also measure the binding activity of TSPO in cutaneous malignant     tissues compared to normal tissues   "
154201|NCT01265459|"     The purpose of the study is to assess the safety and efficacy profiles of new     single-injection volumes of Durolane in patients with knee OA.   "
154202|NCT01265446|"     This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg +     cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg     lozenge in the treatment of sore throat due to a common cold.   "
154203|NCT01265433|"     The doctors are testing a Wilms Tumor-1 (WT1) vaccine to see if it delays or prevents the     mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates     gene expression and causes cell growth. Mesothelioma tumors generally have high levels of     WT1.This study was originally designed to have two treatment groups. One group received     non-specific immunotherapy with medications called Montanide and Sargramostim (Granulocyte     Macrophage Colony Stimulating Factor, GM-CSF). Enrollment to this group has stopped The other     group, which continues receives more specific immunotherapy with the WT1 vaccine plus     Montanide and GM-CSF. Both Montanide and GM-CSF are commonly given along with vaccines     because they have a general effect in boosting the immune response. Some researchers believe     that this general increase in the immune system may have some effect in treating cancer. Some     studies using GM-CSF with melanoma vaccines have suggested that it could lessen the effects     of the vaccine. The addition of the WT1 proteins makes this therapy more directed to     mesothelioma. The combination of WT1 vaccine with Montanide and GM-CSF has been tested in a     prior trial including 9 patients with advanced mesothelioma. In that trial, the vaccine was     safe and caused an immune response.   "
154204|NCT01265420|"     This study will evaluate the efficacy and safety of clostridial collagenase injections for     treatment of Dupuytren's contracture of the thumb and first web space. The investigators     hypothesis is that clostridial collagenase will have safety not significantly different to     that demonstrated in Phase III clinical trials, and will be effective in significantly     reducing the degree of thumb contracture.   "
154214|NCT01265290|"     The purpose of this study is to assess efficacy of prolonged Full Disclosure     electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology     to diagnose syncope in comparison with standard diagnostic procedure   "
154215|NCT01265277|"     When babies start day care, they experience many changes, some of which may affect their risk     for sudden infant death syndrome (SIDS). The investigators want to find out if stress or     change in the baby's sleep patterns can be a reason for this increased risk for SIDS.   "
154205|NCT01265407|"     Background:      - Malaria is a leading cause of morbidity and mortality in Uganda, accounting for more than a     quarter of all outpatient visits at health facilities, 20 percent of hospital admissions, and     about 10 percent of inpatient deaths. Children under 10 years of age, pregnant women, and     HIV-infected individuals bear the greatest burden of disease. To provide baseline information     for future malaria vaccine research, development, and testing, researchers are interested in     collecting malaria infection data from the Rakai district in southern Uganda.      Objectives:      - To assess the epidemiology of malaria infection among children aged 6 months to less than     10 years and adults living in same households with children in Rakai district, Uganda.      Eligibility:      - Children between 6 months and 10 years of age, as well as their primary caregiver and an     additional randomly selected adolescent or adult resident of the household, from the Rakai     district of Uganda.      Design:        -  Participants will have monthly household visits for a 1-year surveillance period.        -  Each visit will include a structured interview/questionnaire of the primary caregiver or          legal guardian of the child and clinical and laboratory assessments of each child, the          primary caregiver, and the additional adolescent or adult resident of the household. The          questionnaire will ask about malaria treatment and prevention measures.        -  Children will provide a blood sample for testing. Individuals (children or adults) who          are diagnosed with malaria or anemia during the course of the study will be recommended          for treatment.        -  Researchers will also track usage of the district health clinic and hospital services to          link medical records for study participants.   "
154206|NCT01265394|"     Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD).     The study drug helps produce pictures of amyloid in the brain. The purpose of this study is     to determine how well the study drug performs in young healthy subjects.   "
154207|NCT01265381|"     Background:      - The Ukrainian Research Center for Radiation Medicine and the U.S. National Institutes of     Health have been studying cancer risks and outcomes in individuals who participated in the     decontamination clean-up process following the Chornobyl nuclear accident. Some of these     individuals were exposed to external radiation at various levels, as well as radioactive     iodine that may have affected the thyroid and increased the risk of developing thyroid     cancer. Because more individual and comparative data are needed on the affected populations     and clean-up workers associated with the Chornobyl accident, researchers are interested in     collecting personal information and saliva samples from Chornobyl clean-up workers who have     been diagnosed with thyroid cancer.      Objectives:      - To assess the radiation-related risk of thyroid cancer among male Chornobyl clean-up     workers and collect saliva samples for an initial study.      Eligibility:      - Male Chornobyl clean-up workers from Kyiv and Donetsk oblasts who have been diagnosed with     thyroid cancer.      Design:        -  Participants will complete a standardized questionnaire during a personal interview. The          questionnaire will ask for detailed information on the following areas of study:        -  Work history, conditions, and activities inside the 70-km clean-up and radiation          calculation zone.        -  Residence history inside and outside the 30-km exclusion zone.        -  Milk consumption between April 26 and June 30, 1986 (to assess radioactivity from          radioiodine fallout).        -  Potential non-radiation risk factors for thyroid cancer (e.g., smoking, alcohol          consumption, family cancer history).        -  Participants will provide a saliva sample for pilot study testing.   "
154208|NCT01265368|"     This is a Phase 1/2, proof-of-principle clinical study to assess safety and efficacy of a     intradermally administered tumor vaccine (MGN1601). The study will be conducted in patients     with advanced renal cell carcinoma.   "
154209|NCT01265355|"     Rotavirus is the commonest cause of severe gastroenteritis in young children worldwide. The     investigators hypothesize that use of a food based prophylactic will decrease incidence of     rotavirus infection in young children in south India, prevent intestinal damage and overall     result in lower infection rates and better gut function. This trial will evaluate the     efficacy of prevention of rotavirus gastroenteritis when an anti-rotavirus protein or     antibody fragments expressed in yeast or placebo are given daily as a food supplement to     children between the ages of 6 and 12 months. The children will followed for one year and     rates of rotavirus diarrhoea, antibody responses and gut function will be compared between     children receiving antibody fragments or placebo.   "
154210|NCT01265342|"     Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as symptomatic     treatment of upper respiratory infections without evidence of efficacy.      The purpose of this study is to evaluate the efficacy of beclomethasone (administered by     nebuliser twice a day) in preventing viral wheezing in pre-school children who had had     episodes in the preceding 12 months.   "
154997|NCT01255072|"     This double-blind, controlled and randomized study intents to investigate the antidepressive     response of rTMS on the elderly population.This is the first neuronavegated pulse intensity     corrected study of rTMS in elderly depressed patients.   "
154211|NCT01265329|"     In spite of the achievements and developement of the assisted reproduction techniques in the     last years, there is still an elevated percentage of unsuccessful treatments, needing     sometimes repeated attempts to reach pregnancy.      The molecular physiology of sperm is being better characterized, and some reports have     demonstrated the implication of different molecular processes in the pathophysiology of male     infertility.      Recently, different sperm selection methods have been based on these molecular differences,     showing a better quality of the sperm population after selection.      The main objective of this research project is to clinically apply these techniques in order     to increase the pregnancy rates per cycle in infertile couples attending assisted     reproduction treatments.   "
154212|NCT01265316|"     Outcomes for pediatric cardiopulmonary resuscitation (CPR) are suboptimal. CPR quality is     directly related to resuscitation outcome, yet numerous deficiencies in CPR quality have been     documented in adult studies. While similar deficiencies can be expected in pediatric     resuscitation attempts, there is little to no data evaluating the existing quality of CPR     performed during resuscitation attempts. Therefore, the objective of this study is to     quantitatively evaluate existing CPR quality using a Q-CPR compression sensor manufactured by     Philips Medical Systems with technology from Laerdal Medical.   "
154213|NCT01265303|"     The purpose of this study is to assess efficacy of prolonged Full Disclosure ECG monitoring     and signal analysis using advanced GSM telemetric technology to prescribe the most     appropriate treatment of arrhythmia.   "
154217|NCT01265251|"     A computerised neuropsychological test battery to be used as a standardised tool assessing     the cognitive domains affected by idiopathic normal pressure hydrocephalus INPH was     developed. The aim of this study is to investigate the reliability, validity and feasibility     of the battery.   "
154218|NCT01265238|"     Spastic equinovarus foot (SEF) is a major cause of disability in stroke patients. Treatments     may include physical therapy, orthosis, botulinum toxin (BTX) injections, selective tibial     neurotomy and tendon lengthening and/or transfer.      Until now, no study has been conducted to assess the result of neuro-orthopaedic surgery in     the treatment of SEF.      The aim of this study is to evaluate the benefit of neuro-orthopaedic surgery (selective     neurotomy and/or Achilles tendon lengthening and/or tibialis anterior transfer) in case of     SEF according to the 3 domains of the International Classification of Functioning, Disability     and Health (ICF)of the World Health organisation (WHO)   "
154219|NCT01265225|"     The goal of the investigators study is to identify a prognostic marker that will evaluate the     probability of recurrence in patients with stage 0-II breast cancer following surgery to     remove the tumor.   "
154220|NCT01265212|"     HPV infection is associated with cervical and other anogenital cancers. HPV may also be     associated with the development of prostate cancer. The purpose of the study is to determine     the prevalence of HPV infection in men living in South Dakota.   "
154221|NCT01265199|"     The main purpose of this study are to determine the maximum dose of AT-406 that can be safely     given in combination with cytarabine and daunorubicin to humans. Other purposes are to     determine how the drug is broken down in the body, and to see if there are any molecular     interactions that can help determine how AT-406 works. Side effects will also be studied in     an effort to make sure that this drug is safe to take.   "
154222|NCT01265186|"     Neonates treated on Neonatal Intensive Care Units are often critically ill, subject to     numerous painful procedures and often dependent on mechanical ventilation. Mechanical     ventilation as well as painful conditions require a sufficient analgesia and or an accurately     regulated sedation. Newborns incapable of self-report are therefore dependent on the     assessment of the infants level of pain and sedation by the treating team.      The aim of this prospective, controlled, observer-blinded clinical trial is to compare the     performance of two EEG based methods and a clinical sedation scale to measure the level of     sedation in neonates. The Bispectral-Index (BIS) and the amplitude-integrated EEG (aEEG) are     compared with the Neonatal Pain and Sedation Scale (N-PASS). We hypothesize a correlation     between the clinical sedation score (N-PASS), the bispectral index (BIS) and the     amplitude-integrated EEG (aEEG). Fifty-two mechanically ventilated term neonates and fifteen     control patients are enrolled and observed for up to 72h.   "
154223|NCT01265173|"     Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver     cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several     antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear     which drug is most effective. Our aim of study is to compare the efficacy of the three     current antibiotics for the treatment of SBP in patients with liver cirrhosis.      The primary hypothesis is that the efficacy of all the antibiotics will not significantly     different. This is non-inferiority trial.   "
154224|NCT01265160|"     Jiangzhuo prescription ,fenofibrate and placebo in the treatment of hyperlipidemia(syndrome     of phlegm obstruction), randomized, parallel-controlled, multi-center clinical study   "
154225|NCT01265147|"     This phase II trial is studying cisplatin or nedaplatin combine with IMRT to evaluate which     one is better efficacy and security in nasopharyngeal carcinoma.   "
154226|NCT01265134|"     The purpose of this study is to measure the ability of balance controlling and test the     evaluation of clinical trials with different arch insoles. The investigators want to find out     the difference and efficacy of arch insoles in the dynamic postural control for the elderly.   "
154273|NCT01264744|"     The purpose of the study is the identification of chromosomal aberrations in urine samples.      The imaging system is intended for diagnostic use as an aid to the pathologist in the     detection, counting and classification of UroVysion FISH stained Urine samples.   "
154228|NCT01265108|"     During alveolar hypoxia, for example at high altitude or in patients with respiratory     disease, there is evidence to suggest that hypoxia-induced pulmonary hypertension might limit     exercise performance. Intravenous iron supplementation has recently been shown to reverse     pulmonary hypertension in healthy humans at high altitude, and to prevent pulmonary     hypertension in volunteers exposed to hypoxia at sea level. The investigators hypothesized     that intravenous iron supplementation would enhance exercise capacity during alveolar     hypoxia.   "
154229|NCT01265095|"     The investigators hypothesized that quantitative PCR can be used in VRE bacteremia outcome     monitoring. Vancomycin-resistant enterococci (VRE) was first found in 1988 and has become an     important healthcare-associated pathogen due to rapid spread, limited options for therapy and     the possibility of transferring vancomycin resistance to more virulent pathogens. VRE     infections not only contribute to more hospital cost and longer length of hospital stay, but     also higher attributable mortality compared to those caused by vancomycin susceptible     enterococci. Two different meta-analyses have shown that vancomycin resistance is an     independent predictor of death among patients with enterococcal bloodstrem infections (BSIs).     Despite this, few effective antibiotics are approved by the US Food and Drug Administration     for the treatment of serious VRE infections. Though several studies have conducted to find     the possible mortality predictors, but none has used bacterial load as a marker.      Schonheyder et al. have used semiquantitative culture, and demonstrate the relationship     between high bacterial load and mortality. However, it may take more than two days before     culture result available, and the sensitivity of culture is greatly affected by antimicrobial     treatment. Real-time PCR has been demonstrate good performance in early detection of     bacteremia, and theoretically is less affected by antimicrobial usage. However, using     quantitative real-time PCR to quantify VRE in blood has not been explored, yet.      The objective of this study is to establish a quantitative method to measure the amounts of     VRE in blood using the VRE specific van gene. And test the hypothesis that higher VRE load in     blood results in higher mortality among patients with VRE BSIs.      Primers and probe of VRE Real-time PCR will be constructed first. The investigators will     prospective enroll patient with VRE bacteremia. Clinical data and outcome will be monitored.     Bacteria load of VRE bacteremia will be measured via established real-time PCR. The outcome     and the association of bacteria load of VRE bacteremia will be analyzed.   "
154230|NCT01265082|"     The following is the investigators hypothesis regarding the pruritus of BP patients during     remission. Anti-BP 180 IgE binds to dermal mast cells, inducing their activation and     secretion of mediators after being cross-linked by antigens. Among mediators, histamine     directly induces itching and vessel changes, whereas tryptase potentiates itching and vessel     changes in an indirect way through the actions of neuropeptides. Tryptase stimulates neurons     which in turn secrete neuropeptides.   "
160852|NCT00000292|"     The purpose of this study is to develop an experimental paradigm to examine acute withdrawal     symptoms from cocaine.   "
154231|NCT01265069|"     Currently, a 10-day concomitant therapy has been reported to be equally effective and safe to     the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy. To     our knowledge, there has been no report concerning the efficacy of this regimen used as a     rescue therapy.      The aims of this study are:        1. to compare the efficacy of high dose dual therapy and concomitant therapy as rescue          regimen in H. pylori eradication;        2. to compare the patient adherence and adverse effects of these treatment regimens;        3. to investigate factors that may influence H. pylori eradication by these treatment          regimens.   "
154232|NCT01265056|"     Burn patients have extreme pain. Opioids are the main agents used for analgesia. Opioids can     have several adverse outcomes and have been only partially effective in controlling the pain     assoicated with burn injury. Agents directed at neuropathic pain are rarely used acutely in     thermal injury. However, there is mounting evidence from small randomized clinical studies     that the administration of the anticonvulsant Gabapentin decreases acute burn pain and has an     opioid sparing effect. We therefore propose a single center study to fruther assess the     efficacy of neuropathic agents in controlling the pain associated with acute thermal injury.   "
154233|NCT01265043|"     The main aim of this oral health intervention project is to compare the effect of providing     1) professional oral hygiene instruction alone versus 2) professional oral hygiene     instruction plus adjunctive Chlorhexidine mouth rinse versus 3) professional oral hygiene     instruction plus adjunctive assisted tooth brushing and Chlorhexidine mouth rinse, on the     oral health condition, the general health condition and health-related quality of life     (HRQoL) of patients with stroke who are receiving hospital-based rehabilitation. An     additional aim is to assess potential longer term oral intervention-related health and HRQoL     outcomes.   "
154234|NCT01265030|"     Desmoid-type fibromatosis (or desmoid tumor) represents an intermediate grade neoplasm with a     striking predilection for locally invasive growth and recurrence following resection. It     occurs in children as well as young adults. As a typically localized disease, the historical     standard of care for treatment has been surgical resection, with or without ionizing     radiation. In some cases where surgical resection or radiation is not feasible, chemotherapy     has been used. Two clinical trials conducted in the Pediatric Oncology Group (POG) and the     Children's Oncology Group (COG) evaluated the role for either low intensity or non-cytotoxic     chemotherapy for children with desmoid tumor that is not amenable to standard therapy. These     were largely empirical treatment strategies or based on somewhat anecdotal observations. By     better understanding desmoid tumor biology, even more effective therapy targeting a     particular protein that is central to the disease can be developed.      Desmoid tumor is well-known to be associated with deregulation of the Adenomatous Polyposis     Cell/beta-catenin (APC/β-catenin pathway). This is true of familial cases associated with     Gardner's Syndrome and also in sporadic desmoid tumor, nearly all of which display     histological or molecular evidence of Adenomatous Polyposis Cell/beta-catenin (APC β-catenin)     pathway activation (Alman et al., 1997; Lips et al., 2009). Several new pieces of evidence     support the concept that deregulation of the mammalian target of rapamycin (mTOR) cell     proliferation/survival pathway may play an important role in tumor biology when the     APC/β-catenin pathway is disrupted. Sirolimus, a drug that inhibits mammalian target of     rapamycin (mTOR), is currently being evaluated as an anti-cancer agent in a variety of tumor     types, but it has not been previously studied in desmoid tumor.      The investigators are conducting this pilot study to begin to explore whether mTOR inhibition     may be beneficial for children and young adults with desmoid tumor.   "
154235|NCT01265017|"     This is a randomized, double-masked, placebo-controlled, single-center study to evaluate     stimulated C-peptide secretion after exogenous administration of mild immunosuppression and     growth-promoting factors to women with preexisting T1DM who had a decline in insulin     requirement or had detectable C-peptide during a previous pregnancy. Fifteen subjects will be     enrolled and randomly assigned in a 2:1 ratio to either active treatment or placebo in a     parallel group design.      Participation for individual subjects will consist of an initial Screening Visit, a 2-week     baseline period, a Baseline Visit, visits at week 2 and 4 of the treatment period, a visit at     the end of the treatment period (week 6), and a follow-up visit 2 weeks after study treatment     discontinuation.      Subjects will receive either active treatment or matching placebo of estradiol 1 mg every 8     hours; medroxyprogesterone 2.5 mg every 24 hours; hydrocortisone 2.5 mg every morning, 1.25     mg every afternoon, and 1.25 mg at bedtime each night; and growth hormone 2 mg once a day).   "
154236|NCT01265004|"     This project investigates microcirculation in skin and tendon after a rupture of the Achilles     tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the     combination of both.   "
154998|NCT01255059|"     To study the association of Genetic Polymorphisms with Lung Cancer Risk in Tianjin     Population.   "
154237|NCT01264991|"     BACKGROUND Osteoarthritis (OA) is the most common form of arthritis and the knee is one of     the most affected joints. The meniscus plays an important role in the development of knee OA.     It is unclear whether a degenerative meniscus tear is a risk factor in developing knee OA or     a sign of the disease. The standard treatment for a degenerative meniscus tear is an     arthroscopic partial meniscectomy (APM). There is strong evidence that this puts the knee at     high risk of later developing OA. Earlier studies have shown a significant placebo effect     from surgical procedures, in general, and an arthroscopic knee procedure, in particular.      PURPOSE The overall purpose of this study is to gather information that might lead to a     reduction in the development of OA in middle-aged patients. The investigators hypothesise     that the benefit from an arthroscopic partial meniscectomy is due to the placebo effect     measured on self-reported outcomes, and that the meniscectomy contributes to the development     of knee OA as seen on radiography.      METHODS The investigators will include 100 patients aged from 35 to 55 years with an     MRI-confirmed medial meniscus tear and without knee OA (excluding patients with Grade 3 or 4     knee OA on the Kellgren-Lawrence classification). Participants will be randomised to either a     standard APM procedure or a sham procedure and both groups will receive standard     post-operative care. The primary outcomes will be a self-reported questionnaire, the KOOS     score, and a functionality test after 3 and 24 months.   "
154238|NCT01264978|"     The aims of this study are:1.To evaluate the utility of quadriceps RMNMS (repetitive magnetic     neuromuscular stimulation) in the evolution of COPD patients after hospital admission for     acute exacerbation.2 To evaluate the time schedule of recovery changes in muscle parameters     ,exercise capacity and quality of life after acute exacerbation. 3.To test the use of this     new method of training in acute clinical situations. Patients: COPD patients admitted to the     Hospital with acute exacerbation. Group 1: RMNMS Treatment .Group 2 : sham RMNMS treatment.     Randomized assignment by minimization method. PROTOCOL Training Group: 10 days after     discharge and during 8 weeks, 2-3 days/week.      Measures: Spirometry, Plethysmography ,Diffusion Test. Main outcomes: Exercise test (Six     minutes walking distance). Muscle function: MVC. Health related quality of life.   "
154239|NCT01264965|"     To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older     persons with no and mild to moderate cognitive impairment and persistent moderate or higher     intensity non-cancer lower extremity arthritis pain; and Describe the association of change     in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and     brief physical performance measure) and to determine if cognitive status modifies this     relationship.   "
154240|NCT01264952|"     The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with     bleomycin in treatment of liver metastases of colorectal cancer in clinical study phase I and     II.      The study will include 10-15 patients with colorectal cancer with synchronous or metachronous     liver metastases, but electrochemotherapy will be performed on metastasis not more than 3 cm     in the largest diameter.      Treatment effectiveness will be evaluated by magnetic resonance imaging (MRI) and     ultrasonography (US) in a monthly interval. Two or three month after the first operation the     treated and untreated metastases will be resected and through histological analyses     performed.      The secondary objectives of the trial are to quantify the impact of the treatment on the     patient's quality of life, tolerance to the therapy and suitability for larger study to be     conducted.   "
154241|NCT01264939|"     The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled,     parallel-group study to evaluate the safety and efficacy of omalizumab administered     subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged     12-75 who have been diagnosed with chronic idiopathic urticaria (CIU) who remain symptomatic     despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the     approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).   "
154242|NCT01263951|"     The goal of this study is to determine the effect of combining everolimus and sorafenib in     patients with metastatic differentiated thyroid cancer who progressed on sorafenib alone.   "
154243|NCT01263938|"     Activated monocytes play a key role in the pathogenesis of HIV-associated neurocognitive     disorders (HAND). Individuals with HAND have expanded populations of activated monocytes.     These monocytes are thought to emigrate into the CNS, where they produce neurotoxic     proinflammatory factors, and also carry virus into the CNS. Statins are cholesterol lowering     drugs with pleiotropic immunomodulatory / anti-inflammatory properties that are currently     being explored for immunomodulation of T cell activation in several diseases, in addition to     their established role to treat hyperlipidemia and atherosclerosis. The investigators in     vitro data suggests that these drugs can downregulate monocyte activation patterns seen in     HIV infection. No in vivo studies have yet been carried out to assess the effects of statins     on the pro-inflammatory monocyte population in chronic HIV disease. This will be a pilot     study of whether statin treatment will reduce the inflammatory monocyte phenotype and     downregulate the inflammatory cytokines that have been linked to neuropathogenesis in HIV     infection. If so, they may have potential as adjunctive therapy in HIV-associated     neurological disease. The investigators propose to:        -  Determine the effect of Atorvastatin on peripheral blood monocyte populations in a          12-week pilot study in chronically HIV-infected people on HAART therapy.        -  Determine the relationship between changes in monocyte phenotype following Atorvastatin          treatment, and soluble markers of activation/inflammation linked to neuropathogenesis,          as well as activation status of T cells.   "
154244|NCT01263925|"     Investigate, under outpatient conditions, both the effect of 4 weeks of daily treatment with     Prostaglandin E1 and that of 4 weeks of interval treatment (two infusions per week) on the     pain-free walking distance in patients with Intermittent Claudication.   "
154245|NCT01263912|"     This is a prospective longitudinal study that will involve 200 infants enrolled at 12-13     months of age. The study will use a classic nutrition design to assess if infants' feeding     practices in Canada place infants 1-2 years of age at risk for low long chain polyunsaturated     fatty acid (LCPUFA), nutrients known to influence growth, and brain and immune system     development. On enrollment, infants will be assigned at random to a nutrition supplement     providing omega 6 and omega 3 LCPUFA or a PUFA placebo.   "
154999|NCT01255046|"     The objective of this study is to evaluate the efficacy and safety of STA-1 vs placebo as an     add-on treatment to donepezil in patients with mild to moderate Alzheimer's Disease (AD).   "
154247|NCT01263886|"     Primary Objective:        -  To demonstrate progression free survival (PFS) improvement for ombrabulin compared to          placebo, in combination with taxane and platinum, as first line treatment for patients          with metastatic non-small cell lung cancer (NSCLC).      Secondary Objective:        -  To determine overall survival (OS), overall response rate (ORR) according to Response          Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential          biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite,          RPR258063, using a population approach.   "
154248|NCT01263873|"     The purpose of the study is to determine if there are differences related to ease of     intubation reported by clinicians who use the Parker Flex-Tip® endotracheal     tubes(ETT)compared to the standard Mallinckrodt® (ETT). The problem is two (ETTs), the Parker     Flex-Tip® and the Mallinckrodt®, are currently available for use in operative suites for     intubation, but few studies have compared these devices with each other. Two research     questions to be answered in the study are 1. Is there a difference in the ease of intubation     when the Parker Flex-Tip® (ETT) is used when compared to the standard Mallinckrodt® (ETT)?     and 2. Are there differences in the number of successful intubations when comparing the     Parker Flex-Tip® (ETT) and the standard Mallinckrodt® (ETT)? The hypotheses are the use of     the Parker Flex-Tip® (ETT) will demonstrate: 1. Fewer seconds to intubate the trachea. 2.     Higher self-reported ease of placement scores and 3. Fewer redirections to intubate the     trachea. The number of successful intubations is expected to be the same in both arms of the     study.   "
154249|NCT01263860|"     Patients with HCV genotype 6 infection who have a rapid virological response to treatment are     randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no     important difference in effect between the two treatment effect.   "
154250|NCT01263847|"     The purpose of this study is to determine the effects of galactooligosaccharide (GOS)     supplementation on calcium absorption and and gut microbe profiles.   "
154251|NCT01263834|"     The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on     the result of trabeculectomy in primary term of intraocular pressure (IOP).   "
154252|NCT01263821|"     RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor     definition, thus may lead to better tumor targeting and avoid damaging critical parts of     normal brain.      PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating     patients with newly diagnosed intracranial glioma.   "
154253|NCT01263808|"     This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral     moxifloxacin.   "
154254|NCT01263782|"     The goal of this clinical research study is to learn if knowing biomarker status can help     researchers find better treatment combinations for patients with advanced NSCLC.      Researchers want to use biomarker status to decide what drug (bevacizumab, or cixutumumab) to     give in combination with carboplatin and pemetrexed. The safety of these drug combinations     will also be studied.   "
154255|NCT01263769|"     The goal of this clinical research study is to learn if axitinib can help to control kidney     cancer. The safety of this drug will also be studied.   "
154256|NCT01263756|"     The proposed pilot study will begin to assess whether driving impairments are included in the     functional deficits associated with Autism Spectrum Disorders (ASDs). This will be completed     by obtaining data on velocity, collision risk, and visual attention of subjects with ASDs who     drive in a simulator. The study includes 2-3 visits for the screening period (approximately 6     hours of assessments) and one driving simulation visit (approximately 2.5 hours). The     investigators expect to enroll 20 adolescents and adults (ages 16-50, inclusive) who have     been identified as having an ASD from a prior diagnosis or participation in community     conferences for individuals with ASDs.   "
154257|NCT01263743|"     Interventions such as Relaxation Response appear to have widespread effects on physiology.     Endothelial function, changes in genomic expression, several biomarkers have been associated     with chronic stress and cardiovascular dysfunction, and there is some suggestion that     elicitation of the Relaxation Response may lead to improvement in-or normalization of-these     factors. By studying the impact of the Relaxation Response on endothelial function, genomic     expression and biomarkers among subjects with hypertension, it may be possible to better     understand the biologic underpinnings of Relaxation Response-type interventions. Furthermore,     with a greater understanding of the physiologic mechanisms by which the Relaxation Response     works, it may be possible to better target other symptoms and conditions that can be     effectively treated by such an intervention.   "
154258|NCT01263730|"     The goal of this research is to evaluate whether Tai Chi merits further investigation as a     non-pharmacological therapy in the treatment of Major Depressive Disorder (MDD).     Specifically, this waitlist-controlled study will gather preliminary data evaluating the     effectiveness of Tai Chi training as treatment for patients with MDD or a history of MDD,     including patients who continue to be depressed despite taking antidepressants and patients     who choose not to take antidepressants due to fear of side effects and/or for personal     reasons. To test this hypothesis the investigators will compare physical and psychological     parameters of a control group and an intervention group, at baseline (Week 0), at the     midpoint (Week 6), and at the end of 12 weeks of Tai Chi training.   "
154259|NCT01264926|"     The Objective is to evaluation the difference between the upper end of the Humerus head and     the bottom end of the Acromion in sitting and lying, and to examine this difference to     shoulder pain.   "
154260|NCT01264913|"     The overall goal of the present application is to test the hypothesis that shift workers, who     are chronically exposed to circadian misalignment and sleep loss, have a higher     cardio-metabolic risk than day workers, and that the accumulated sleep debt and the degree of     circadian misalignment both predict their elevated cardio-metabolic risk.   "
154274|NCT01264731|"     The purpose of the study is to determine 1) the safety of administration of topical 5%     imiquimod cream with or without administration of a peptide-based vaccine in patients with     cutaneous metastases of melanoma and 2) evaluate whether topical imiquimod at sites of     melanoma metastasis, with or without vaccine, increases a) endothelial expression of     E-selectin and b) T cell infiltration.   "
155122|NCT01253447|"     This phase II trial is studying how well AKT inhibitor MK-2206 works in treating patients     with relapsed or refractory acute myeloid leukemia (AML). AKT inhibitor MK-2206 may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
154261|NCT01264900|"     Aggressive behavior is a leading worldwide public health problem. Despite this, relatively     little is known about how to best treat individuals who are highly angry and aggressive. A     rich literature suggests that aggression is associated with a tendency to interpret     situations as threatening or hostile even when they are not. This process is governed by a     prefrontal-limbic circuit in the brain. A goal of cognitive behavioral therapy is to reduce     these kinds of hostile biases. Preliminary data by the PI suggests a 12- session cognitive     behavioral aggression treatment (CBAT) may help reduce aggressive behavior and underlying     hostile biases associated with affective aggression. To assess the efficacy of this     treatment, 120 adults with high levels of anger and aggression will receive 12 sessions of     either CBAT or supportive psychotherapy. All subjects will monitor their anger and aggressive     behavior throughout the treatment electronic diaries. Subjects will also complete     questionnaires and computer tasks to assess anger, hostile biases and related processes     1-week before treatment begins, and again 1-week, 6-months and 1-year after treatment ends.     In addition, to understand the effects of CBAT on the brain, subjects will have their brains     scanned (functional Magnetic Resonance Imaging) while they look at emotional pictures and     complete computer tasks. The brain scans will occur once before treatment starts and once     after treatment ends.      Our hypotheses are:        1. CBAT will reduce anger, aggression and hostile biases more than supportive therapy.        2. CBAT will decrease limbic activation and increase prefrontal activation to emotional          pictures more than supportive therapy.   "
154262|NCT01264887|"     The purpose of this trial is the characterization of the long term safety profile and     long-term dose requirements of tapentadol PR (prolonged release) in patients with malignant     tumor-related pain. In the United States the prolonged-release formulation is also referred     to as the extended-release formulation.   "
154263|NCT01264874|"     The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence     in resected stage II melanoma patients.   "
158722|NCT01206361|"     The hypothesis is that there is no difference in persistency between Xalacom and the     alternative fixed dose combination products (Duotrav and Ganfort) over a 12 month period.   "
154264|NCT01264861|"     This is a study of safinamide, an investigational drug for Parkinson disease (PD). Safinamide     is being developed as add-on therapy for the treatment of Parkinson disease. It is theorized     that safinamide acts by increasing the available dopamine in those areas of the brain where     dopamine is decreased as a result of Parkinson;s Disease. . Dopamine in the brain is involved     in controlling body movements. Safinamide has been extensively studied in animals, and has     been shown to increase the level of dopamine in these animals. Safinamide has also been     tested in patients with Parkinson disease. The goal of this research trial is to see if     safinamide is safe and well tolerated and to better understand how it affects the dopamine     system in the brain in individuals with Parkinson disease. Data from this trial may provide     essential information about the effectiveness and safety of these doses of safinamide in     patients with early Parkinson disease, who are already receiving a stable dose of their     normal Parkinson disease treatment.   "
154265|NCT01264848|"     The aim of this study is to assess the efficacy of endovascular treatment (balloon     angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis     patients.   "
154266|NCT01264835|"     This trial is designed to assess intra-operative procedure outcomes (e.g.,procedure duration)     and post-operative patient outcomes (e.g., pain)following a modified Ferguson     hemorrhoidectomy procedure using the Slotted Anoscope with Harmonic or monopolar energy.   "
154267|NCT01264822|"     To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori   "
154268|NCT01264809|"     The prevalence of type 2 diabetes is high and expected to increase dramatically in worldwide,     in France and especially in the French West Indies.This chronic disease is associated with     premature mortality and various debilitating complications which can be prevented by optimal     control of glycaemia, blood pressure and lipids. Diabetes management includes lifestyle     modification and medication. Despite numerous studies supporting the benefits of frequent     physical activity for people with Type 2 diabetes, an estimated 60±80% of this population     remain sedentary. Promotion of physical activity in current diabetes care seems to be     inadequate.      The aim of this randomized controlled trial is to evaluate the medium-term effectiveness     (after 3 and 6months) of exercise consultation in promoting physical activity in outpatients     with Type 2 diabetes.   "
154269|NCT01264796|"     The primary aims are to test the effectiveness of the self-help DM intervention (SHIP-DM), a     comprehensive, culturally tailored DM management intervention, in improving glucose outcomes;     To determine the effectiveness of the SHIP-DM in KAI with type 2 DM in improving self-care     skills and psycho-behavioral outcomes related to DM control, to develop tangible     infrastructures for the dissemination of valid and effective education materials to a wider     population of KAI with type 2 DM in the US (e.g., audio-visual education materials, web-based     intervention materials, mobile telephone-based intervention materials) and to explore the     feasibility and acceptability of each dissemination module, utilizing the delayed     intervention group participants. The secondary aims are to obtain preliminary     cost-effectiveness data related to the proposed intervention, including cost estimates for     this type of DM intervention, and to establish a systematic, long-term dissemination plan,     including documenting effective methodologies, to facilitate faster translation of research     findings and products to direct consumers in non-research settings.   "
154270|NCT01264783|"     The objective of this study is to evaluate the safety and tolerability of RNS60 administered     intravenously to healthy subjects. 12 subjects will receive RNS60 or placebo at three     escalating rates for 48 hours for each rate.   "
154271|NCT01264770|"     The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid     arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are     Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an     inadequate response to DMARDs. The study will last for approximately six months   "
154272|NCT01264757|"     This feasibility study specifically addresses the issue of adapting US dietary guidelines     physical activity recommendations to the population of the Lower Mississippi Delta. The     hypothesis is that including a pedometer as a self-monitoring tool as part of adapted     physical activity guidelines will result in greater immediate increases in physical activity     (as monitored by an accelerometer) than an education program alone.   "
154370|NCT01263249|"     To determine if the way local anesthetic, or numbing medication, is delivered through a tiny     tube next to the nerves that go to the thigh affects the strength and sensation in the thigh.   "
154275|NCT01264718|"     9.6 million US Children (13%) have no health insurance, Latino and African-American children     account for 57% of uninsured children, although comprising only 37% of all US Children.     Studies show that being uninsured has a negative impact on children's health, healthcare, and     mortality, however, insuring children results in improved health and healthcare. About 70% of     uninsured US children (6 million) are eligible for but not enrolled in Medicaid or the     Children's Health Insurance Program (CHIP), innovative strategies are needed to insure more     children and eliminate disparities. This is the first randomized controlled trial comparing     the effectiveness of parent mentors (PMs) to traditional Medicaid/CHIP outreach and     enrollment in insuring uninsured minority children. The primary study aims are to evaluate     whether PMs are more effective and more cost-effective than traditional Medicaid/CHIP     outreach and enrollment in uninsured children. The secondary aim is to determine whether     children who obtain health insurance experience improvements in healthcare access, health     status, use of services, and other health outcomes.      Subjects will be 300 Dallas County uninsured and Medicaid/CHIP eligible Latino and     African-American children (90% of insured children) and their parent/guardian. Subjects will     be randomized to PMs or a control group receiving traditional Medicaid/CHIP outreach. PMs are     experienced parents who have a child currently covered by Medicaid/CHIP. PMs will undergo     intensive training, and will be paired with intervention subjects and their families, for     whom they will provide information on Medicaid/CHIP eligibility, help complete/submit     insurance applications, act as a liaison, and assist in maintaining coverage. Primary     outcomes will include obtaining health insurance, coverage continuity, time interval to     obtain coverage, parental satisfaction with the process of obtaining insurance and costs;     secondary outcomes will include access to care, health status, use of services, quality of     life, Parental satisfaction, financial burden, and missed school/parental work days. Subjects     will be contacted monthly for 1 year to monitor outcomes by a blinded assessor. Achievement     of study aims has the potential to contribute to reducing racial/ethnic disparities, and     advancing knowledge and practice of child health policy. This intervention could serve as a     national model for insuring uninsured children and reducing racial/ethnic disparities in     insurance coverage.   "
154276|NCT01264705|"     This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of     bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This     study will be activated at the UT Southwestern Medical Center, comprised of The Harold C.     Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland Memorial     Hospital System. Advanced HCC is defined as disease that is not amenable to surgical     resection or orthotopic liver transplantation or is metastatic in nature.   "
154277|NCT01264692|"     The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral     administration of ACT 280778 on DBP compared to placebo after 28 days.   "
154279|NCT01264666|"     Background: human studies of Chinese liquor are sparse. we hypothesis that Chinese Tea Flavor     liquor may be beneficial to CVD risk factors postprandially.      Design: three-way crossover design with one week wash time.16 young men were included to     consume 60mL Chinese tea flavor liquor(45% alcohol content), Chinese Meijiao liquor 45%     alcohol content) or water control.Blood samples were collected fasted, 0.5,1,2,4 hours     postprandially.      Tested serum indices: lipids, glucose, insulin, hs-CRP, uric acid, liver function parameters.   "
154280|NCT01264653|"     The purpose of this study is to study the safety and efficacy of intracameral adrenaline for     pupil dilation without topical mydriatics in refractive cataract surgery.   "
154281|NCT01264640|"     The impact of anti-platelet drugs on the concentrations of Brain-derived neurotrophic factor     (BDNF) in human plasma and serum is unknown. It is the aim of this study to investigate the     impact of a single dose of Aspirin (500 mg) or Clopdigrel (600 mg) on the concentrations of     Brain-derived neurotrophic factor (BDNF) in plasma and serum of healthy volunteers.   "
154282|NCT01264627|"     A recent National Health Interview Survey reported that breathing exercises were the second     most common complementary and alternative medicine practice in the United States, following     only the use of natural products. With such widespread interest in breathing exercises,     alone or as a component of practices such as meditation, a need exists for research that     examines not only its efficacy, but also investigates potential mechanisms of action. Indeed,     a recent National Center for Complementary and Alternative Medicine (NCCAM) Meditation     Workshop recommended research to clarify biological pathways by which meditation practices,     including breathing exercises, can impact health. To explore mechanisms underlying the health     effects of breathing exercises, new translational tools are needed that can measure breathing     patterns in both the clinic and natural environment. The primary objective of the present     proposal is the application of a new technology to the investigation of pathways by which     breathing exercises can affect health. For this project, the health-related outcome measure     to be studied is a major cardiovascular risk factor, blood pressure.   "
154283|NCT01264614|"     This study will evaluate the effects of low-intensity strengthening exercise on the brain     (thinking and processing speed) for patients with early dementia, compared with normative     older adults. Participants will engage in 3 months of exercise 3-5 times per week using a     chair and small weights. It is hypothesized that there will be a significant improvement in     brain function.   "
154284|NCT01264601|"     Historically, providing influenza vaccination of egg allergic children and young adults (EAC)     with a history of anaphylaxis to egg, or other severe symptoms of an allergic reaction to egg     (e.g., severe hives, swelling, or asthma), has been contra-indicated, though vaccination of     children with less severe egg allergy has been shown to be safe. Though many children with     severe egg allergy, including anaphylaxis, have received past influenza vaccination     anecdotally, very few data exist to show this procedure is safe. The investigators propose a     double blind, placebo-controlled randomized, prospective multi-centered study to a)     demonstrate seasonal trivalent influenza vaccine (TIV) can be safely given in a single dose     (as opposed to through 2-step graded dosing of 10% then 90% of the vaccine dose) to EAC     despite history of anaphylaxis or previous severe allergic reaction to egg; and b) provide     further evidence that adverse outcomes are not related to ovalbumin (egg) content in TIV.      Study participants must have a documented history of a severe egg allergy, substantiated by     both a history of clinical reactivity AND either a positive skin test or ImmunoCAP/RAST test     greater than 0.7 kUA/L. Participants will be randomized to receive either a 2-step graded     challenge or a single dose given after a small placebo dose of saline (to mimic the graded     challenge). If required, all participants will receive a booster vaccination as a single     dose.   "
154285|NCT01264588|"     The purpose of this study is to determine whether topical application of calcium     glycerophosphate will result in superior wound appearance and scar minimization.   "
154286|NCT01264575|"     This prospective randomized double-blind dose-response study is aimed to investigate the ED50     and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee     replacement arthroplasty.   "
154371|NCT01263236|"     The purpose of this study is to investigate the safety and tolerability of ascending single     and multiple oral doses of LY2940094 in healthy male subjects.   "
154287|NCT01264562|"     The study will investigate the impact of cancer-related stress and its consequences (acute     and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in     breast cancer patients. The hypothesis that stress associated with the cancer diagnosis and     the cancer treatment is a major cause of cognitive dysfunction in breast cancer patients     shall be evaluated.   "
154288|NCT01264549|"     Development of stroke associated pneumonia (SAP) has a detrimental effect on stroke outcome.     Biomarker-guided antibiotic treatment of patients at high risk for pneumonia may help to     improve stroke outcome. Therefore, the investigators will evaluate whether intensified     infection monitoring via Procalcitonin guiding an early standardized antibiotic treatment     improves functional outcome after stroke compared with standard therapy based on current     guidelines.   "
154289|NCT01264536|"     We will test the hypothesis that bovine lactoferrin supplementation prevents serious     infections in preterm infants. We will conduct a randomized placebo-controlled double blind     study in 190 premature infants <2500 gm in 5 Neonatal Intermediate and Intensive Care Units     in Lima, Peru to determine whether bovine lactoferrin prevents the first episode of     late-onset sepsis.   "
154290|NCT01264523|"     The main objective of this study is to evaluate the effects on anthropometric, glucose     metabolism and lipid profile biomarkers of exchanging with high-protein, low-glycemic index     products (40-30-30) the habitual breakfast, mid-morning and afternoon snacks on type-2     diabetes patients following a chronologically scheduled pattern.   "
154307|NCT01264302|"     The objective of this study was to evaluate the relative bioavailability of the test     formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference     formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.)under fed conditions in healthy adult     male subjects.   "
154308|NCT01264289|"     The objective of this study was to evaluate the relative bioavailability of the test     formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference     formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.)under fasting conditions in healthy adult     male subjects.   "
154291|NCT01264510|"     A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid, and     a sound processor connected with the implant. The sound processor delivers bone conducted     stimuli to the cochlea, bypassing the outer and middle ear.      Some patients who are unable to wear or do not benefit from a conventional air-conduction     hearing aid, are candidate for a Baha. Typically, these patients suffer from a conductive or     a mixed hearing loss. Recently however, Baha's are also being recommended in patients with     unilateral deafness. Sound coming from the deaf side is captured and transmitted through bone     conduction to the normal inner ear. The overall benefit of a Baha is more difficult to assess     in those patients.      Therefore, the goal of the current study is to examine the benefit of a Baha in patients with     different audiological profiles (unilateral or bilateral conductive or mixed hearing loss,     and unilateral deafness). Special attention will be given to predictive determinants of the     benefit with a Baha, and to the improvement of pre-operative criteria and counseling of     patients.   "
154292|NCT01264497|"     The purpose of this study was to determine whether TH9507, a stabilized analogue of growth     hormone-releasing factor (GRF), would have an effect on insulin sensitivity or control of     diabetes in patients with type 2 diabetes.   "
154293|NCT01264484|"     The objective of this study is to assess long term safety and durability of the Advantage     prosthetic heart valve.   "
154294|NCT01264471|"     The purpose of the study is to investigate possible causes for Gulf War Syndrome. Gulf War     Syndrome is associated with increased incidences of amyotrophic lateral sclerosis (Lou     Gehrig's Disease), pain syndromes, muscle complaints that include fatigue and myalgias     (muscle pain), as well as other neurological symptoms. Abnormalities in the part of the cell     known as mitochondria have been delineated in Gulf War Syndrome. Mitochondria are the power     plants of the body. Mitochondria take the food you eat and break the food down into a form     of energy that the body can use. The investigators propose that Gulf War Syndrome is     determined by a complex interaction of factors that interfere with mitochondrial function.     This study will be the first investigation of mitochondrial function in Gulf War Syndrome.     The investigators objective is to establish the cause for symptoms in affected veterans,     develop testing that can more easily identify Gulf War Syndrome, and ultimately develop     treatment protocols for Gulf War Syndrome.   "
154295|NCT01264458|"     The purpose of this research study is to look at how trauma affects the ability of blood to     clot. The blood of people who suffer a traumatic injury can under-clot or over-clot, and this     research study will look at blood drawn from people after they suffer a traumatic injury to     see how well their blood clots.   "
154296|NCT01264445|"     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an     adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months 1,     2, 3, and 4.   "
154297|NCT01264432|"     This phase I trial studies the side effects and best dose of veliparib when given together     with radiation therapy in treating patients with advanced solid malignancies (abnormal cells     divide without control and can invade nearby tissues) with peritoneal carcinomatosis,     epithelial ovarian, fallopian, or primary peritoneal cancer. Veliparib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses     high energy x rays to kill tumor cells. Giving veliparib with radiation therapy may kill more     tumor cells.   "
154298|NCT01264419|"     The purpose of this study is to demonstrate the safety and feasibility of the Silk Road     Medical Embolic Protection System for use in subjects who are candidates for Carotid Artery     Stenting (CAS). Safety is a composite of any major stroke, myocardial infarction and death     during the 30-day post procedural period.   "
154299|NCT01264406|"     This study will compare the effect of two doses of exercise on energy intake and body weight.     The comparison will be between three groups; two exercise groups and a control group. The     exercise groups will not be provided with a dietary intervention and the study design also     includes a non-exercise control group. E-Mechanic trial can make important contributions to     understanding of the role of exercise dose in weight management. While it is accepted that     regular exercise plays an important role in general health, the exact role of exercise in     prevention of weight gain, weight loss and prevention of weight regain remains poorly     understood despite exercise being widely prescribed for these purposes. The idea that current     weight management exercise recommendations may produce increased energy intake (or other     forms on compensation) resulting in disappointing weight loss is an important public health     issue. The finding of this study could help shape future exercise and weight loss     recommendations and treatment plans.   "
154386|NCT01263041|"     effects of enteral l-arginine to decrease feeding intolerance and risk of NEC in neonates via     its role as a NO precursor. Also, enteral glutamine which may play a role as an     immunomodulator on preterm neonates. all these had never been studied in developing countries     where sepsis and nec act as a major participant in mortality rates.   "
154300|NCT01264393|"     Behavioral weight loss programs can successfully reduce body weight, but these programs are     available to limited numbers of overweight and obese individuals. This project evaluates a     unique weight loss approach that combines a self-sustaining weight loss campaign (for     outreach) with training in behavioral weight loss strategies and strategies to increase     accountability (to improve weight loss success). This innovative combination has the     potential to be a cost-effective model for disseminating weight control interventions.   "
154301|NCT01264380|"     This randomized, open-label, two period crossover study will evaluate the effect of food on     the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous     administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients     will be randomized to receive in a crossover design single oral doses of RO5185426 with or     without food, with a 10-day washout period between doses. Following the crossover periods,     patients will receive RO5185426 orally twice daily on a continuous basis until disease     progression or unacceptable toxicity occurs.   "
154302|NCT01264367|"     A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence     compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine     and peg-interferon sequential treatment in patients with chronic Hepatitis B who have     HBeAg(+)   "
154303|NCT01264354|"     This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir     and clevudine combination in patients with chronic hepatitis B.   "
154309|NCT01264276|"     The primary objective of this multi-center clinical study is to evaluate the validity,     reliability, feasibility, safety and relative cost-effectiveness of a retinopathy of     prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies who meet     referral warranted ROP (RW-ROP) criteria and therefore need a diagnostic evaluation by an     ophthalmologist experienced in ROP.      We shall:        1. Calculate the accuracy, using sensitivity and specificity, of the system to provide          remote evaluations when compared with the findings of a gold standard indirect          ophthalmoscopic examination performed by a Study-certified ophthalmologist, rigorously          trained in ROP diagnostic examinations (validity);        2. Determine intra-reader and inter-reader agreement for deciding whether digital images          indicate that the eyes of a baby are in need of diagnostic indirect ophthalmoscopy by an          ophthalmologist experienced in ROP (reliability);        3. Determine whether imaging evaluation can be achieved for each baby (feasibility);        4. Examine ocular and systemic complications associated with digital imaging and compared          with those associated with diagnostic examinations performed by an ophthalmologist          (safety);        5. Compare the costs and benefits of adopting a telemedicine retinal imaging system          compared to the current cost of indirect ophthalmoscopic examinations          (cost-effectiveness).   "
154310|NCT01264263|"     This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and     several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean diabetic     patients with atherosclerosis. Total 360 patients will be enrolled through 6 sites.   "
154311|NCT01264250|"     In this early phase study, healthy male volunteers will be randomly assigned to one dose of     either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and     Pharmacokinetics of AZD2927.   "
154312|NCT01264237|"     The present study will aim to determine the safety, efficacy, and tolerability of etoricoxib,     an NSAID pain reliever, in patients with Neuropathic pain. Neuropathic pain, or pain caused     by abnormal activity of sensory neurons, remains undertreated. Post herpetic neuralgia (PHN),     which is commonly referred to as post-shingles pain, is the most useful disease to study when     investigating the efficacy of pain relievers for Neuropathic pain. Therefore, this study will     primarily involve patients with PHN.      The hypothesis in this study is that etoricoxib efficacy is superior to that of placebo.   "
154313|NCT01264224|"     1. Primary Objective:             -  To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028               in healthy male volunteers.        2. Secondary Objective:             -  To evaluate pharmacokinetics and pharmacodynamics of single and multiple oral               dosing of PAC-14028 in healthy male volunteers.   "
154314|NCT01264211|"     To evaluate the efficacy of Diacerein 100 mg daily versus placebo in reducing rheumatoid     arthritis symptoms, when added to stable oral MTX therapy in patients with active early RA.      To evaluate the safety of Diacerein 100 mg daily when administrated in combination with oral     MTX therapy in those patients for up to 24 weeks      To investigate a potential persistent effect, 4 weeks after Diacerein treatment is stopped     (carry-over effect)   "
154315|NCT01264198|"     The aim of the study is to evaluate the effect of RT on clinical and metabolic parameters in     patients with NAFLD.   "
154316|NCT01264185|"     The purpose of this study is to conduct preparatory research needed to design a behavioral     intervention to decrease sexual transmission risk behaviors in HIV-infected individuals in     care and to determine whether a similar intervention structure can be used across various     sexual risk groups and cultural settings.   "
154317|NCT01264172|"     This project investigate any difference in inflammatory response,wound heeling rate,     functional outcome and level of pain in patience with different surgical treatment (PCCT vs.     DHS vs. Osteosynthesis with nails) after a fracture of the proximal femur.   "
154318|NCT01264159|"     It is well known that 20-25% of patients hospitalized for acute myocardial infarction will     develop acute heart failure during their hospitalization. Currently, the investigators have     no reliable parameter for prediction of evolving acute heart failure in such a group of     patients. As a result, the investigators have no way of preventing acute heart failure.     Treatment of these patients only begins after appearance of clinical signs of acute heart     failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of     evolving acute heart failure. This study will attempt to address whether preemptive lung     impedence-guided therapy may prevent the development of overt acute heart failure and improve     their clinical outcome.   "
154319|NCT01264146|"     This study aims to test the hypothesis that postoperative daily hyperbaric oxygen therapy     (HBOT) decreases soft-tissue complication rate during the operative handling of     intra-articular calcaneal fractures. Minor motivations: 1. To evaluate microcirculatory     criteria of cutaneous tissue predicting emerging wound healing defects, 2. To identify     patients at risk for soft-tissue complication after calcaneal plate osteosynthesis and to     determine the optimal time point for operative intervention using these microcirculatory     criteria preoperatively, 3. To evaluate the effect of HBOT on postoperative microcirculation,     4. To collect preliminary data to evaluate the economical impact of wound complications, with     and without HBOT, 5. To identify a correlation between HBOT with expected limited soft-tissue     complication rate and the clinical and radiographic outcome two years after surgery.   "
154320|NCT01264133|"     An open study to Evaluate the Efficacy, Safety and Sustained effect of Clevudine monotherapy     or Adefovir and Clevudine combination in proportion to Roadmap concept in Patients with     chronic hepatitis B.   "
154358|NCT01263405|"     The purpose of this study is to determine the ability of a specific imaging method, termed     Diffuse Optical Spectroscopic Imaging, to provide metabolic and functional information which     can be used to predict overall response to preoperative (neoadjuvant) chemotherapy in     patients with sarcomas. Sarcoma patients face comparatively poor response rates to     chemotherapy and early, non-invasive indications of response could provide physicians with     the information necessary to make evidence-based changes in treatment strategies. Patients     who do not demonstrate early signs of response would be spared the unnecessary side-effects     of an ineffective chemotherapy regimen, and could either be switched to a different regimen     or undergo surgery   "
154500|NCT01261559|"     The primary hypothesis of this study is that breast displacement out of the direct plane of     imaging during computed tomography (CT) of the abdomen will reduce effective radiation dose     to the female breast. Secondary hypotheses are that image noise and artifacts will also be     decreased.   "
154321|NCT01264120|"     Obesity is a major health problem that is affecting more and more people's lives. One of the     most successful treatments for obesity is weight loss surgery. Not all patients, however,     lose the desired amount of weight, some regain weight and some have the surgery reversed.     Interviews with patients and discussions with patient support groups indicate that many of     the 'unsuccessful' patients feel unprepared for the operation and describe how although the     surgery fixes their body it neglects their mind. They would therefore like to have more     psychological support.      The present study aims to set up and evaluate a health psychology led bariatric     rehabilitation service (BRS) and determine the impact of such a service on patient outcomes     following surgery. The BRS would offer information, support and mentoring pre and post     surgery and address psychological issues such as dietary control, self esteem, coping and     emotional eating. It is predicted that a bariatric rehabilitation service would primarily     improve weight loss following surgery but would also aid changes in other aspects of the     patient's well being.      Obesity is a risk factor for a multitude of illnesses such as heart disease, diabetes and     cancer. If effective, obesity surgery improves a patient's health and reduces their need for     NHS care. If unsuccessful then the costs include not only subsequent NHS costs due to these     other illnesses but also the costs of the unsuccessful operation and the emotional cost to     the patient. The bariatric rehabilitation service should help to improve the effectiveness of     surgery which in the longer term is likely to be cost effective.      This research is a direct response to the needs identified by patients and by offering a more     comprehensive bariatric service the success and subsequent health and well being of obese     patients should be improved.   "
154322|NCT01264107|"     An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With     Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.   "
154323|NCT01264094|"     The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic     Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.   "
154324|NCT01264081|"     Background:      - Studies of melanoma tumor samples have shown that tumor cells from approximately 20 percent     of melanoma patients contain a specific mutation of a gene involved in making a protein     called ERBB4, and that changes in this gene have been associated with cancer. Lapatinib, a     drug that is currently approved for the treatment of breast cancer, has been shown in the     laboratory to significantly slow the growth of melanoma cells that contain this specific     ERBB4 gene mutation. Researchers are interested in determining whether lapatinib can be     effective against melanoma in individuals who have the ERBB4 mutation.      Objectives:      - To evaluate the safety and effectiveness of lapatinib as a treatment for melanoma with     ERBB4 mutation that has not responded to standard therapy.      Eligibility:      - Individuals at least 18 years of age who have stage 4 melanoma that has not responded to     standard therapy.      Design:        -  Participants will be screened with a full physical examination and medical history, as          well as tests of tumor tissue taken from previous surgeries or biopsies or from a new          biopsy that will be conducted before the start of the study. Test results to determine          eligibility will be available within about 2 weeks.        -  Participants will take four lapatinib tablets daily (two in the morning, 1 hour before          or after breakfast and two in the evening, 1 hour before or after dinner) during every          28-day cycle of treatment. Participants will keep a medication diary to record tablets          taken and any side effects from the medication.        -  After the first 2 weeks, and every 2 to 4 weeks afterward for the first 12 weeks,          participants will have clinic visits with blood samples and other tests to determine if          lapatinib is causing their disease to shrink or be controlled. If the disease has not          progressed, participants will continue to receive a new lapatinib supply every 28 days          for up to 2 years (27 cycles), and will continue to have regular clinic visits to          monitor the progress of treatment.        -  When tumor tissue is easily accessible and can be easily biopsied, researchers will          collect two additional biopsies, one after 2 weeks of treatment and one after 12 weeks          of treatment....   "
154325|NCT01264068|"     Traditional Chinese herbal medicine, no matter mono-therapy or poly-pharmacy, is composed of     complicated chemical constituents. Many confounding factors influence activity of Chinese     herbs, including the origin of the herbs, safety of the products and consistency between     batches. Study of the effectiveness and mechanism of Chinese herbs in vivo is much more     challengeable due to unresolved problems of product quality control, screen of effective     principles, monitor of the marker constituents and the targets for site of action. In this     project, we will introduce the concept of metabolomics to detect total metabolites spectra as     the biomarkers of Chinese herbs intervention. Correlation will be analyzed between changes in     total metabolites and clinical improvements when menopausal women receive Suan Tsao Jen Tang     or Jia Wey Shiau Yau San, and postpartum women receive生化湯.   "
154326|NCT01264055|"     Background:      - Bronchiectasis is a type of lung condition in which the lungs airways are abnormally     stretched and widened. This stretching and widening makes it difficult for mucus and other     substances to move out of the lungs, encouraging the growth of bacteria and leading to     breathing problems or infection. Bronchiectasis can be caused by genetic disorders or     diseases such as tuberculosis or rheumatoid arthritis. Researchers are interested in     developing better ways to diagnose and treat a lung problem called idiopathic or unexplained     bronchiectasis.      Objectives:      - To better describe the physical characteristics, radiographic patterns, and airway     microbiology of unexplained bronchiectasis and to look for possible genetic links or risk     factors.      Eligibility:        -  Individuals at least 18 years of age who have a chronic cough and who have had a CT scan          that has revealed signs of bronchiectasis.        -  Current smokers or those who have smoked for at least 10 years, as well as individuals          who have known causes of bronchiectasis or who have had organ transplants, are not          eligible to participate.      Design:        -  Participants will have one outpatient clinic visit for evaluation with a physical          examination including detailed body size measurements and medical history and for          collection of blood samples for routine lab tests and genetic analyses and a chest x-ray          if no recent one is available.        -  Participants will also have tests of lung function, and measurement of a gas called          nitric oxide in the nose. Participants whose initial tests show abnormal results may          also be asked to have a nasal scrape to collect cell samples and/or a skin sweat test to          measure salt concentrations.        -  Participants will also have a sputum specimen collected during the visit and will be          asked to collect two additional early morning sputum samples and a mouth rinse at home          within 2 weeks of the clinic visit, and mail the sample collection materials to the          research team....   "
155123|NCT01253434|"     The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in     healthy Japanese male volunteers.   "
154327|NCT01264042|"     Although the essential role of iron during pregnancy is well established, concerns have been     raised that current iron supplements given routinely during pregnancy may also have harmful     consequences, such as increased oxidative stress and enhanced risks of infection,     pre-eclampsia and impaired glucose regulation. A potential mechanism for the production of     adverse effects is the appearance of non-transferrin-bound iron after oral administration of     iron supplements. Non-transferrin-bound iron is more readily available to pathogens and could     promote injurious free radical reactions that might add to the oxidative stress of pregnancy.      The present study will determine if oral administration of 60 mg of iron as ferrous sulfate     during the second trimester of pregnancy is followed by the appearance of     non-transferrin-bound iron two hours later. The investigators will examine the influence of a     variety of factors, including iron status and previous use of iron supplements. Detection of     non-transferrin-bound iron after administration of an iron supplement to pregnant women would     be an important new observation that could lead to re-evaluation of current methods of iron     supplementation.   "
154373|NCT01263210|"     Acute otitis media (AOM) is a common childhood disease, which becomes recurrent in 15-20% of     the cases. Streptococcus pneumoniae is one of the leading causative agents, and a small     reduction in the number of AOM episodes has been noted in unselected child cohorts after     vaccination with conjugate heptavalent pneumococcal vaccine. This study was performed in     order to investigate whether vaccination could reduce the number of AOM episodes in very     young, otitis-prone children.   "
154501|NCT01261546|"     STUDY JUSTIFICATION        1. Scientific evidence of the usefulness of corticosteroid use for infectious diseases:          Corticosteroids along with antibiotic use improve survival in some infectious processes          provide long term benefits and improve symptoms in many others.        2. Clinical Observation: the investigators observed that patients with parapneumonic          pleural effusion and associated bronchospasm who were treated with corticosteroids for          their bronchospasm, evolved to healing before patients who were not treated with          corticosteroids (average admission days 10 vs. 17).        3. Rationale: the anti-inflammatory effect has been the rationale for the use of          dexamethasone as an inhibitor of the inflammatory response observed after the first dose          of parenteral antibiotic in bacterial meningitis. A similar effect is likely to occur in          pneumonia with pleural effusion. It can be therefore hypothesized that Dexamethasone          could inhibit an excessive inflammatory response by mesothelial and inflammatory cells          during the early phases of parapneumonic empyema, reducing its severity and hence its          complications.      OBJECTIVES        1. Principal: to investigate if dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic          therapy reduces time to resolution of parapneumonic pleural effusion.        2. Secondary:      2.1. Evaluate the effect of dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic     therapy on the development of complications during pleural effusion episode.      2.2. Evaluate the incidence of severe and non severe adverse events associated with the new     treatment versus standard therapy.      METHODS        1. Study design: exploratory (pilot), randomized, double blinded, placebo controlled,          parallel stratified design, multicentric.        2. Participating Hospitals (n=56, 7 patients per center):             -  Hospital Infanta Sofía (S. Sebastián de los Reyes, Madrid).             -  Hospital Universitario de Getafe             -  Hospital Universitario Ramón y Cajal, Madrid.             -  Hospital Universitario Materno-Infantil Carlos Haya, Málaga.             -  Hospital Infantil La Paz, Madrid.             -  Hospital U. Gregorio Marañón             -  Hospital U. Príncipe de Asturias             -  Hospital Virgen de la Salud, Toledo        3. Endpoints:           3.1. Primary: time to resolution. 3.2. Secondary endpoints:             1. Effectiveness: number of children with complications.             2. Safety (expected number: none). i) Hyperglycemia ii) Signs of gastrointestinal               bleeding iii) Need of transfusion iv) Oropharyngeal Candidiasis v) Allergic               reaction vi) Other adverse reactions described in the Medication Guide.        4. Treatment arms:      3.1. Control (0)        -  Normal saline 0,6 ml/kg, IV, q.i.d. for 2 days.        -  Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present.        -  Ranitidine 5 mg/kg IV, q.d. for 2 days.        -  Amoxicillin- Clavulanic acid 80mg/kg p.o., q.d. during 15 days.      3.2. Study treatment: (1)        -  dexamethasone 0,25mg/kg, IV, q.i.d. for 2 days.        -  Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present        -  Ranitidine 5 mg/kg IV, q.d. for 2 days        -  Amoxicillin/Clavulanic acid orally (80mg/kg/day) during 15 days.           4. INCLUSION CRITERIA        -  Patients between 1 and 14 year old.        -  Presence of pneumonia diagnosed by clinical and radiographic criteria: cough, fever and          radiological consolidation.        -  Evidence of pleural effusion.   "
154328|NCT01264029|"     Background:        -  New weight-loss intervention programs are being studied to determine their effectiveness          in helping overweight and obese individuals reach a healthy weight. However, these          programs often have not been tested against each other, and researchers are interested          in determining which interventions are most effective both immediately and over the long          term in promoting and maintaining weight loss.        -  Mindful Tai Chi is a combined form of the meditative martial art tai chi and the          practice of mindfulness meditation. Tai chi and mindfulness meditation both have common          philosophical underpinnings that address health promotion and well-being by applying the          skill of non-judgmental awareness on a moment-to-moment daily basis. More research is          needed on whether Mindful Tai Chi and mindfulness meditation can help improve various          health factors in overweight and obese individuals.      Objectives:      - To compare the effects of Mindful Tai Chi, mindfulness meditation, walking, or a discussion     group on the weight and well being of overweight and obese participants.      Eligibility:      - Healthy individuals at least 18 years of age who are either overweight or obese (body mass     index between 25 and 40), have a sedentary lifestyle (have not engaged in more than 1 hour of     aerobic exercise per week within the last month), and are willing to commit to a specific     weight-loss intervention program.      Design:        -  This study involves four visits for collecting information and 12 weeks of research          study activities.        -  During the first visit, participants will hear information about the study and may ask          any questions. They will be screened with a medical history and physical examination,          and those eligible will be assigned to one of the four study groups: Mindful Tai Chi          (MTC), Mindfulness Meditation (MM), Mall Walking (MW), or Weekly Discussion (WD) group.        -  For the second visit, participants will give blood and urine samples, receive an          abdominal ultrasound, ride a stationary bicycle for 5 minutes, and fill out          health-related questionnaires.        -  For 12 weeks, participants will be involved in the following activities depending on          their group:        -  MTC: Class for 2 hours per week, emphasizing the meditation aspects of tai chi. Each          session will include at least 20 minutes of meditation. Participants will receive          written instructions and an accompanying DVD in comparable formats specifying a minimum          of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a          workshop for mindfulness skill application in daily activity.        -  MM: Class for 2 hours per week of mindfulness meditation. Participants will receive          written instructions and an accompanying DVD in comparable formats specifying a minimum          of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a          workshop for mindfulness skill application in daily activity.        -  MW: Participants will meet at a designated mall location once a week for 2-hour walk.        -  WD: Participants will meet at the National Institutes of Health for weekly weight-loss          discussion.        -  For the third and fourth visits, participants will receive the same procedures as those          used in the second visit. These visits will occur at the end of the 12-week activity          period and at a 3-month follow up visit.   "
154329|NCT01264016|"     The purpose of this study is to evaluate the performance and acceptability of a new blood     glucose monitoring system, which includes meter and sensor strip.   "
154330|NCT01264003|"     Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when     prosthetic materials are used. This prospective randomized study has been set to observe if     antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.   "
154331|NCT01263990|"     Main hypothesis: there is no difference between stroke volume measurements recorded by a new     noninvasive finger cuff system (NexFin) and invasive hemodynamic monitoring systems as     Picco2-system, FloTrac and transesophageal echocardiography   "
154332|NCT01263977|"     Septic shock and multi-organ failure are among the most frequent causes of death in the ICU.      Patients with septic shock require early implementation of hemodynamic therapy to keep the     duration of shock state and with it microcirculatory disturbances as short as possible. In     the septic shock guidelines by the american association SCCM the diagnosis of volume status     is based on filling pressures, like CVP. Some studies show, that the CVP depends not only on     the intravascular volume, but also on the right ventricular compliance, pulmonary vascular     resistance as well as intrathoracic pressure. The aim of the Study is to evaluate if the     duration of septic shock can be reduced through algorithm driven volume therapy orientated to     thermodilution based volume parameters (GEDI and ELWI)   "
154333|NCT01263964|"     The primary objective of the prospective observational trial TRELAS (TRoponin ELevation in     Acute ischemic Stroke) is to elucidate the underlying pathomechanism of cTnT elevation in     acute ischemic stroke. Consecutive patients with acute ischemic stroke admitted to the     Department of Neurology Campus Benjamin Franklin of the university hospital Charité will be     screened for cTnT elevations suggestive of myocardial infarction (>0,05 µg/l). Patients with     increased troponin will undergo diagnostic coronary angiography within 72 hours. Diagnostic     findings of coronary angiographies taken out in age- and gender-matched patients presenting     with NSTE-ACS (Non-ST-Elevation Acute Coronary Syndrome) to the Division of Cardiology will     serve as a control. The primary endpoint of the study will be the occurrence of culprit     lesions indicating focal cardiac damage on the basis of an acute CAD.   "
154334|NCT01263717|"     HIV-infection and its treatment are often associated with an increase in belly fat, as well     as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and     increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may     contribute independently to increased belly fat and to increased cardiovascular risk through     effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth     hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients     with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat     accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet     known. The current study is designed to determine the effects of tesamorelin treatment on fat     accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers     of cardiovascular health including blood vessel thickness (carotid intima media thickness     [cIMT]) and markers of inflammation in the body. The investigators hypothesize that     tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers     of inflammation, with either neutral or beneficial effects on glucose metabolism.   "
154335|NCT01263704|"     This single arm, open-label study will assess the safety and efficacy of low dose fludarabine     and cyclophosphamide in combination with standard dose MabThera/Rituxan (rituximab) as     primary therapy in elderly patients (>/= 65 years) with chronic lymphocytic leukemia.     Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375 mg/m2     intravenously [iv] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine (12.5     mg/m2/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles 1-6).     Anticipated time on study treatment is 6 months, with a 30-month follow-up period.   "
154336|NCT01263691|"     The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and     immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and     female subjects between 18 and 50 years of age will receive vaccinations via the     intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via     laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant     medications, and local and systemic signs and symptoms of reactogenicity.   "
154374|NCT01263197|"     The purpose of this study is to determine the effect of LY2216684 on heart rate of healthy     people receiving Albuterol and Propranolol. Information about any side effects that may occur     will also be collected.   "
154375|NCT01263184|"     The studies object is to evaluate the degeneration of overhead sports in wheelchair-using     athletes. It is assumed that wheelchair users do have more symptomatic shoulder pain compared     to non disabled athletes.   "
154337|NCT01263678|"     Treatment options for lumbar spinal stenosis include surgical and non-surgical approaches.     For most people, the decision depends on how bothered they are by their symptoms and how they     feel about having surgery. Since individuals with the same clinical presentation may feel     differently about their symptoms and how they view the benefits and harms of their options,     there is no agreed upon besttreatment. It has been shown that, for preference-sensitive     decisions like this one, decision aids (tools that pair balanced, evidence-based information     regarding treatment options with values clarification) improve patients'knowledge and     realistic expectations, lower decisional conflict, increase patient involvement in decision     making, decrease the number of undecided, and increase agreement between values and choice.1     The Spine Center, in collaboration with the Center for Shared Decision Making (CSDM) at     Dartmouth Hitchcock Medical Center (DHMC), has been providing patients with decision aids     (DAs) for several years.      Hypothesis:      Patients identified as having low literacy and/or high decisional conflict after viewing a     video decision aid will show greater resolution of their decisional conflict, higher decision     self-efficacy and less decision regret if a coaching intervention is paired with a video     decision aid.      Decision support in the form of coaching develops patients'skills in preparing for a     consultation and deliberating about their options.2 A study of women with abnormal uterine     bleeding showed that pairing coaching with a DA helped patients clarify their values and     preferences, reduced costs, and increased long term satisfaction.3 The investigators plan to     assess the impact of coaching in patients with lumbar spinal stenosis who are referred to the     CSDM for a video decision aid about their treatment options. The investigators are also     interested to learn whether screening for low literacy and high decisional conflict can     identify a subgroup of patients who are more likely to benefit from coaching.   "
154338|NCT01263665|"     The purpose of this study is to confirm the safety and performance of the 25 cm GORE®     VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral     Artery.   "
154339|NCT01263652|"     The investigators will conduct a randomized double blind study, to determine whether patient     analgesic delivery mode preference affects pain reduction quality in non-surgical spine     patients.      The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo.     During the study period, pain reduction parameters will be collected. At the end of the study     period, the investigators will attempt to find a correlation between pre-study patient     preferences and the quality of the pain reduction achieved.   "
154340|NCT01263639|"     Objectives: Patient satisfaction is a key determinant of the quality of care and an important     component of pay for performance metrics. The purpose of this study was to evaluate the     impact of a simple intervention aimed to increase patients' understanding of their     orthopaedic trauma surgeon and improve patient satisfaction with the overall quality of     inpatient care delivered by the attending surgeon.      Design: Prospective quality improvement initiative using a randomized intervention.      Setting: Level 1 academic trauma center.      Patients/Participants: Two hundred twelve patients were eligible; 100 patients were     randomized to the intervention group, and 112 patients were randomized to the control group.     Overall, 76 patients could be reached for follow-up satisfaction survey, including 34     patients in the intervention group and 42 patients in the control group.      Intervention: Patients randomized to the intervention group received an attending biosketch     card, which included a picture of the attending orthopaedic surgeon with a brief synopsis of     his educational background, specialty, surgical interests, and research interests.      Main Outcome Measures: Our primary outcome measure was a patient satisfaction survey     assessing patients' rating of the overall quality of inpatient care delivered by the     attending surgeon.   "
154341|NCT01263626|"     The aim of the study is to establish the accuracy of a new device designed specifically to     record and detect cough episodes.      Cough is an important defense mechanism of the respiratory tract. The presence of chronic     cough may indicate the presence of underlying diseases, including reflux. Despite the     increased number of patients suffering from cough in the ENT and GI practice, to date, there     has been no method/device to objectively assess the frequency of cough episodes in a given     patient.      PULMOTRACK-CC, manufactured by KarmelSonix (Haifa, Israel), has recently introduced an     innovative device that is able to record cough episodes and then automatically detect and     count them with the help of a specific software program. This study will assess the accuracy     of this novel cough monitoring and counting technology and validate potential clinical use in     patients with chronic cough.   "
154342|NCT01263613|"     The purpose of this study is to determine if the investigators are able to locate and measure     certain characteristics in breast cancer tumors that have been treated with paclitaxel that     may correlate to how well the cancer will respond to the chemotherapy.   "
154343|NCT01263600|"     The purpose of this study is to describe participants 6 months to <18 years of age with     hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and     Canada and identify predictors of disease activation and progression.   "
154344|NCT01263587|"     The primary purpose of this study is to describe participants with hepatitis B virus (HBV)     infection and identify factors that may cause the disease to activate or worsen.   "
154345|NCT01263574|"     This study is designed to determine if the use of 70% ethanol lock solution in central lines     decreases the rate of central line infections in children with short bowel syndrome. While     ethanol locks have been used safely in children, there has been no published research to date     that clearly shows it is of definite benefit in this group of patients.   "
154346|NCT01263561|"     Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome:     IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from     baseline without medication or additional glaucoma surgery and qualified success defined as     IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but     no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual     acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.   "
154387|NCT01263028|"     Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D     deficiency in the Chronic Kidney Disease population requiring recombinant human     erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of     erythropoietin required to maintain a nonanemic state.   "
155288|NCT01251276|"     The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years     following completion of a primary series with a hepatitis B vaccine (Base Study V232-059,     NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B     vaccine.   "
154414|NCT01262677|"     Approximately 30% percent of subjects with partial seizures are refractory to treatment with     single or combination antiepileptic drugs. The present study will compare the efficacy of two     different dosages of pregabalin CR dosed once daily as compared to placebo, when used as     adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using     a randomized, parallel group design.   "
154347|NCT01263548|"     ADHD in the adult population is associated with several measures of harmful dysfunction. For     example, adult ADHD is associated with high rates of separation/divorce and never-married     status, lower educational attainment and occupational achievement, absenteeism, presenteeism,     and job termination, as well as decreased social function. Individuals with adult ADHD are     more likely than controls to have a comorbid diagnosis of bipolar disorder, alcohol and     substance abuse, as well as antisocial personality disorder.      Psychostimulants are the most frequently employed medications in the treatment of adult ADHD.     Several psychostimulants are Health Canada and US FDA-approved for the treatment of ADHD     symptoms in adulthood.      Hitherto, no trial has evaluated the safety and efficacy of a psychostimulant in the     treatment of ADHD symptomatology in adult individuals with bipolar disorder.      Vyvanse is the first prodrug stimulant indicated for the treatment of adult (and pediatric)     ADHD. Vyvanse is a therapeutically inactive molecule (i.e. prodrug). After oral ingestion,     lisdexamfetamine is converted to l-lysine, a naturally occurring essential amino acid, and     active d-amphetamine, which is responsible for the drug's activity. Vyvanse provides a longer     duration of effect consistent throughout the day with reduced potential for risk of abuse.     Vyvanse is generally well tolerated with an adverse event profile similar to other     psychostimulant medications. Available evidence indicates that in most treated subjects,     Vyvanse is weight-neutral and/or is associated with weight loss. Moreover, in some     individuals, it is associated with improvement in both glucose and lipid homeostasis.      The evaluation of safety/tolerability profiles as well as the effectiveness of     lisdexamfetamine in a real-world population has significant translational value.   "
154348|NCT01263535|"     This clinical trial is designed to investigate the performance of SENSIMED Triggerfish®     during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid     recording intervals over the 24-hour period.      The investigation will recruit male and female patients older than 18 years and diagnosed     with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the     study. Patients will be considered enrolled in the study upon signature of informed consent.     A screening visit and one 24-hour IOP fluctuation monitoring session during a 36-hour     hospitalisation, are planned for each patient.   "
154349|NCT01263522|"     Health-promoting effects of physical exercise are well-investigated especially for endurance     activities. However, for different individuals, positive effects have different sizes, even     non-responders are observed. Other forms of training, such as strength training and interval     training, are less well investigated. Therefore, a comparative longitudinal training study is     warranted to examine differences of preventive effects (outcome measures: ergometric     descriptors of physical performance, established risk factors and prognostic factors for     cardiovascular diseases) of continuous endurance training, interval training and strength     endurance training.      In a second stage, the observed non-responders will perform a different type of training     (cross-over). It is expected, that besides a comparative general efficacy evaluation of the     three training types, improved recommendations for optimized individualization of training     parameters can be formulated.   "
154350|NCT01263509|"     The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and     an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40     consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on     study.   "
154351|NCT01263496|"     The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once     daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40     consecutive weeks in participants who completed a phase 2 dose-ranging study.   "
154352|NCT01263483|"     The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily     (QD) combined with an α-glucosidase inhibitor taken three times daily (TID) in type 2     diabetic patients with uncontrolled blood glucose.   "
154353|NCT01263470|"     The purpose of this study was to evaluate the dose-response relationships of alogliptin, once     daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal     clinical dose for type 2 diabetic patients.   "
154354|NCT01263457|"     This is a National, Multicentre, Observational Registry to study Adherence and Long Term     Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth     hormone treatment from hospital in the UK and to assess the level of adherence of subject     receiving SAIZEN® via Easypod™.   "
154355|NCT01263444|"     The purpose of this study was to evaluate the safety and efficacy of adding AZARGA® as a     single agent to prostaglandin monotherapy in patients with either ocular hypertension or     primary open-angle glaucoma.   "
154356|NCT01263431|"     Aim of the study is to compare short term results of 2 surgical treatment for grade 3     hemorrhoidal disease, namely: pain and postoperative morbidity,complications and     effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction   "
154357|NCT01263418|"     This research study will only include two types of non-Hodgkin Lymphoma (NHL), follicular     lymphoma or marginal zone lymphoma and participants will be age 70 or older.      The purpose of this research study is to learn about the safety of the treatment with the     drug ofatumumab to find out what effects, both good and bad this treatment has on lymphoma.     Ofatumumab is a monoclonal antibody. Monoclonal antibodies are being used to treat some types     of cancer. Monoclonal antibodies are a type of protein made in a laboratory that can bind     substances in the body including cancer cells. Ofatumumab binds to the protein called CD20,     which is found on B-cells and lymphoma cells.      The study drug, Ofatumumab, is approved by the United States Food and Drug Administration     (FDA) for treatment of other types of blood cancer and is not approved for use in patients     with non-Hodgkin Lymphoma. The use of ofatumumab in this study is considered investigational.      In addition to learning about ofatumumab, the researchers are interested in learning about     how this cancer treatment affects daily activities. Participants will be asked to complete a     Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional     status, mental health, and level of social support. This assessment will help the health care     team understand a participant's functional age as compared to a participant's actual age.      The researchers also want to collect blood samples to study molecules in follicular lymphoma     cells called 'biomarkers' to learn about how the lymphoma responds to therapy. A biomarker is     a molecule (for example, DNA or protein) found in the blood or tissues that is a marker for     disease. In this study, the investigators will measure the changes of the biomarker called     bcl-2. This biomarker research will only be in subjects with follicular lymphoma.   "
154388|NCT01263015|"     The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50     mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil     fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48     weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1     infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and     development of viral resistance will be evaluated.   "
154359|NCT01263392|"     The primary aim of this study was to determine if using the SpeediCath hydrophilic catheter     would reduce the incidence of symptomatic urinary tract infections (UTI)in children with     spina bifida who perform clean intermittent catheterization for bladder management. The     hypothesis was that the incidence of symptomatic urinary tract infections would be     significantly reduced (by 25%) in users of the SpeediCath hydrophilic catheter when compared     to users of a reused polyvinyl chloride (PVC) catheter. Subjects were randomly assigned to     either starting the study with PVC catheter for 6 months followed by the hydrophilic catheter     for 6 months or visa versa. Each subject kept a weekly diary recording urinary tract     infections symptoms, hematuria determined by urine dipstick, physician visits, days of missed     school and other activities. At the end of each 6 months subjects completed a questionnaire     recording their comfort and satisfaction in using the PVC or hydrophilic coated catheter. 70     subjects were randomized and 46 had complete data. There were no differences in febrile UTI,     antibiotic use, healthcare visits or school days missed. The incidence of self reported UTI     was lower in the PVC group than the hydrophilic group. 40% of subjects indicated that the     hydrophilic coated catheter was slippery and difficult to handle compared to 10% for the PVC     catheter. However overall satisfaction was no different between products. The study results     are consistent with the current Cochrane Review that there is a lack of evidence to state     that the incidence of UTI is affected by multiuse or hydrophilic catheter use.   "
154360|NCT01263379|"     This trial will create a skin graft, which the investigators call LEAES, using the     patient's own skin cells that have been genetically engineered in the lab to express a     missing protein called type VII collagen. The corrected cells will be transplanted back to     the patient.   "
154361|NCT01263366|"     This study, a nonrandomized open-label Phase I safety and exploratory study, will evaluate     the safety of topical norepinephrine in post-surgical breast cancer patients who are     undergoing radiation therapy.      The study will also provide information about whether topical norepinephrine can prevent or     decrease the severity of the radiation dermatitis experienced by these patients.   "
154362|NCT01263353|"     The purpose of this study is to assess the safety and tolerability of pasireotide LAR in     combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary     neuroendocrine Tumors (NET).   "
154363|NCT01263340|"     The investigators will describe the characteristics, prevalence, incidence, severity     co-morbidity and management of patients with chronic obstructive pulmonary disease (COPD) in     the UK. 100 practices will be sampled amounting to a total study population of about 10 000     patients. Information will be collected electronically and, where necessary, by a hand search     of patient records.   "
154364|NCT01263327|"     This phase I clinical study was designed to evaluate the safety of novel recombinant HPV     16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women     18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV     vaccine administered intramuscularly according to a 0-1-6 month schedule.   "
154365|NCT01263314|"     This is a randomized, double-blind, placebo-controlled study. Two panels, each consisting of     eight participants (8 elderly males with mild to moderate hypertension in Panel A and 8     elderly females with mild to moderate hypertension in Panel B) will be randomized to receive     either MK-8266 or matching placebo in a 3:1 ratio. Participants will receive single doses of     MK-8266 or matching placebo in three treatment periods (Periods 1 through 3). In both Panel A     and Panel B, doses will escalate in a rising, fixed sequence. In Period 1 (0.3 mg), Period 2     (0.6 mg), and Period 3 (1.0 mg) once daily doses of MK-8266 or matching placebo will be     administered. Blood samples will be obtained pre-dose and at selected time points up to 48     hours post-dose for determination of MK-8266 plasma concentrations.   "
154366|NCT01263301|"     Subclavian steal phenomenon is normally observed in patients with stenosis of subclavian     artery proximal to orifice of vertebral artery(V0). However, uremic patients undergoing     hemodialysis using vascular access in the arm or forearm may also develop dialysis associated     steal syndrome(DASS).For patients with symptomatic subclavian steal phenomenon, the treatment     for these two groups is different. The investigators want to see if the investigators can use     noninvasive duplex examination instead of invasive conventional angiography to do the     differential diagnosis.   "
154367|NCT01263288|"     The primary aim of the present trial is to study the effect of daily vitamin D     supplementation on muscular power and force among non-western immigrants living in Oslo,     Norway, and secondarily to study the effect of musculoskeletal pain and headache.      The investigators have also prespecified a number of additional research questions about     anemia, metabolism and bone turnover, inflammation, diabetes, lipids, itching and kidney     function, which because of multiple comparisons should be interpreted with caution unless the     statistical evidence for an effect is very strong.   "
154368|NCT01263275|"     Among antidepressant treatments, ECT stands as the most effective in treating acute     depression. However, patient concerns with the cognitive side effects of ECT have encouraged     the development of new and more focal forms of brain stimulation such as transcranial Direct     Current Stimulation (tDCS). However, not all patients may respond to this treatment in the     way that it is currently administered and this has raised interest in finding alternative,     possibly more optimal ways of administering tDCS. This study will investigate whether tDCS     stimulation using an alternative electrode montage has antidepressant effects.   "
154369|NCT01263262|"     Does the use of chlorhexidine scrub prior to cutaneous surgery on the face increase the     chances of toxicity to the eyes or ears? In addition, does the us eof chlorhexidine scrub on     the face prior to cutaneous surgery decrease the chances of a post-operative wound infection?   "
154372|NCT01263223|"     The purpose of this study is to determine the effect of LY2216684 on heart rate and blood     pressure in research participants with MDD who are being treated with an SSRI (selective     serotonin reuptake inhibitors). Information about any side effects that may occur will also     be collected. The duration of participation in this study is approximately 24 days not     including the screening visit. This study requires 1 clinic confinement of 17 days/16 nights     and 1 Follow-up Outpatient Visit. A screening visit is required within 30 days prior to the     start of the study. In both periods 1 and 2, the study involves 4 single daily doses of 18 mg     LY2216684 or placebo taken as 2 tablets by mouth. In period 3, the study involves four single     daily doses of 36 mg LY2216684 or placebo taken as 4 tablets by mouth.   "
154376|NCT01263171|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells     that remain after surgery.      PURPOSE: This phase II trial is studying giving oxaliplatin, leucovorin, and fluorouracil     together, before and after radiation therapy and surgery in treating patients with rectal     cancer that can be removed by surgery.   "
154377|NCT01263158|"     Slow labour progress is common in nulliparous women and is associated with childbirth     complications and negative birth experiences. Oxytocin augmentation is widely used to treat     slow labour despite associated risks for the fetus. An ongoing debate concerns whether     oxytocin should be administered directly or postponed after arrested labour. The overall aim     is to study labour progress in healthy nulliparous women and to compare childbirth outcomes     and experiences in women randomised to expectant versus early oxytocin augmentation for slow     labour progress.      The hypothesis is that it is to early to start oxytocin treatment when labour progress has     been slow for 2 to 3 hours in healthy women having their first baby and therefore beneficial     for childbirth outcomes to postpone oxytocin for another 3 hours. In this randomised     controlled trial nulliparous women with a normal pregnancy, spontaneous onset of active labor     at term, and a cervical dilatation of 4 - 9 centimetres on admission to the delivery ward     were included (n=2,072). All women whose labour did not progress after amniotomy (n=630) were     randomly allocated either to labour augmentation by oxytocin infusion (Early oxytocin, n=314)     or to postponement of oxytocin augmentation for another three hours (Expectant, n=316). One     month postpartum the women received a postal questionnaire concerning their experiences of     labour and birth. All participating women gave their informed consent. Maternal and neonatal     outcomes like mode of delivery, postpartum haemorrhage, perinatal lacerations, low Apgar     score, need of neonatal intensive care and maternal experiences of childbirth were compared     between the randomised groups.   "
154378|NCT01263145|"     This phase I trial studies the side effects and best dose of Akt inhibitor MK2206 (MK2206)     when given together with paclitaxel and to see how well they work in treating patients with     solid tumors that have spread to other places in the body and usually cannot be cured or     controlled with treatment or breast cancer that has spread to other places in the body. Akt     inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Giving Akt inhibitor MK2206 and paclitaxel may be a     better treatment for solid tumors or breast cancer.   "
154379|NCT01263132|"     This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3     clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined     with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with     chronic distal diabetic polyneuropathy.   "
154380|NCT01263119|"     The purpose of this study is to determine how warfarin might affect LY2216684 and how giving     LY2216684 might affect warfarin in the body. Information about any side effects that may     occur will also be collected.   "
154381|NCT01263106|"     The primary aim of this study is to confirm that LY2216684 is not an inhibitor of CYP1A2 in     vivo using theophylline as a probe substrate for the enzyme. Since LY2216684 has been     observed to increase heart rate in some healthy subjects, this study will also assess heart     rate when co-administered with theophylline.   "
154382|NCT01263093|"     The purpose of this study is to measure how much of the study drugs reach the blood stream     and how long it takes the body to get rid of them, and determine how clopidogrel and     LY2216684 might affect each other in the body. Information about any side effects that may     occur will also be collected.   "
154383|NCT01263080|"     Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the     effects of adding mirtazapine and folic acid to existing therapy for patients with     schizophrenia   "
154384|NCT01263067|"     The purpose of this study is to evaluate if lifespan integration (LI) therapy reduces     posttraumatic stress symptoms following a motor vehicle accident (MVA) trauma   "
154385|NCT01263054|"     The primary objective of this randomized controlled trial is to evaluate the safety and     efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine     using a modified disc biacuplasty procedure. The primary efficacy measure will be the Visual     Analog Scale (VAS) at 6 months post treatment/randomization and the TransDiscal System will     be compared against medical management (standard of care).   "
154391|NCT01262976|"     The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline     (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human     Immunodeficiency Virus (HIV)-positive adults aged 18 to 59 years, living in a tuberculosis     endemic region.      Subjects will be followed-up for 3 years.      Subjects will be enrolled in 3 cohorts:        -  HIV-positive adults on highly active antiretroviral therapy        -  HIV-positive adults not on highly active antiretroviral therapy        -  HIV-negative adults      Each cohort will have 2 groups.   "
154392|NCT01262963|"     The study is a Phase 1, open-label study designed to characterize the absorption,     distribution, metabolism and excretion of GSK2118436 following administration of a single     oral 14C labeled dose of GSK2118436 as a suspension in subjects with BRAF mutation positive     tumors.   "
154415|NCT01262664|"     The goal of this clinical research study is to find the highest tolerable dose of     PROHIBITIN-TP01 that can be given to patients with advanced prostate cancer for which there     are no standard therapy options. The safety of this drug will also be studied.   "
154416|NCT01262651|"     This 9-week study will aim to determine the efficacy, safety and tolerability of Sativex®     (Nabiximols) as an adjunctive treatment, compared with placebo in relieving uncontrolled     persistent chronic pain in patients with advanced cancer.      Eligible patients will not be required to stop any of their current treatments or     medications.   "
154417|NCT01262638|"     This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of     ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.   "
154393|NCT01262950|"     The investigators plan to conduct a first-stage experiment by recruiting ten subjects,     including five PD patients and five non-PD patients. In the beginning, the information     collected by the portable motion detector is used to compare the difference in the activities     performed by PD and non-PD patients. Besides, the algorithm will be developed to identify the     gait patterns of PD patients. Once the system detects the abnormal gaits, such as shuffling     and festinating steps or freezing of gait, auditory cues will be given to the PD patients and     caregivers by their sides. It can help the patient to maintain normal gait and improve the     effectiveness of rehabilitation, as well as preventing falls in daily activities. Moreover,     in case of accident falls, the real-time fall detection mechanism alerts the nearest     caregiver for instant support and delivers this information to the remote family members and     medical personnel.      After that, a second-stage experiment will be carried out by recruiting another five PD     patients. By comparing the gait patterns identified by the system against those identified     manually by the staff, the performance of the proposed system on fall prevention will be     examined. For the patients and their family members, the developed system enhances the     patients' safety in their daily activities. As for the medical personnel, it serves as an     affordable tool that benefits the rehabilitation of PD patients in an easy manner.   "
154394|NCT01262937|"     The goal of the project is to determine whether confocal endomicroscopy can be used to     identify and discriminate among dysplastic, neoplastic, and nonneoplastic tissue, as compared     with histologic specimens as a reference. The project will evaluate those at risk for or with     known Barrett's esophagus, and those with known or suspected biliary strictures. It is our     hypothesis that we will be able to identify between neoplastic and nonneoplastic tissue.   "
154395|NCT01262924|"     The purpose of this study is to assess the immunogenicity and reactogenicity of     GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals)     reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content     diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™   "
154396|NCT01262911|"     SRT2379 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic     inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The     objective of this study is to test if SRT2379 may be a novel compound for the treatment of     inflammatory disorders in man.   "
154397|NCT01262898|"     GSK962040 is a novel small molecule motilin agonist. The Phase I studies (MOT107043 and     MOT109681) demonstrated that single doses of GSK962040 up to 150 mg and repeat dosing of up     to 125 mg/day for 14 days were well tolerated with adverse events not occurring in greater     prevalence than placebo, and no significant abnormal vital sign, ECG, or clinical laboratory     findings. Pharmacokinetic parameters were linear and approximately dose proportional over the     range of doses administered. Single doses of 50 mg - 150 mg GSK962040 significantly increased     the rate of gastric emptying up to 40% as measured by the 13C octanoic acid stable isotope     breath test. A similar effect of 50 mg and 125 mg on gastric emptying was observed throughout     repeated dosing to healthy volunteers for 14-days.      The aims of the present investigation (MOT114479) are to assess the pharmacodynamic effects     (gastric emptying and symptoms), safety, tolerability, and pharmacokinetics of GSK962040     after 28 days of once-daily dosing in Type I and Type II diabetic subjects with     gastroparesis. An additional aim is to characterize the dose/exposure - pharmacodynamic     effect relationship.   "
154398|NCT01262885|"     GSK2251052 ((S)-3-(aminomethyl)-7-(3-hydroxypropoxy)-1-hydroxy-1,3-dihydro-2,1-benzoxaborole     hydrochloride) is a Gram negative antibacterial compound currently in development for the     treatment of hospital acquired Gram negative infection (including E. coli, K. pneumoniae, and     Enterobacter spp.) This study will be conducted in two (2) parts, with single oral doses     being explored in Part A (500, 1000, and 2000 mg) and repeat oral doses (1000 and 2000 mg,     b.i.d.) being explored in Part B. Parts A and B will be single-blind, randomized,     placebo-controlled, dose-rising studies in healthy subjects to evaluate the safety,     tolerability and pharmacokinetics of oral GSK2251052.   "
154399|NCT01262872|"     This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of     GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and     co-administered with other routine paediatric vaccines in infants in The Gambia. Two     formulations containing different doses of pneumococcal antigen and two different schedules     will be tested in infants.   "
154411|NCT01262716|"     This study will assess safety and ergonomics/engineering design of a novel cancer treatment,     Continuous Low Irradiance Photodynamic therapy (CLIPT). We will assess the effects on primary     and metastatic tumors involving the skin, in particular to improve the functionality,     efficiency and wearability of the light delivery device (LDD) as well as the overall     treatment in subjects with chest wall recurrences of breast cancer. An ongoing study (IRB#     8227), sponsored by a Susan G. Komen Breast Cancer Foundation grant, using a 1st generation     LDD device has evaluated and determined a dose-limiting toxicity of CLIPT for subjects with     chest wall recurrences of breast cancer.      A Diomed laser will be the device used in this study. The Diomed laser will deliver 630 nm     (red spectrum) light through a Fiber Optic Patch. The Fiber Optic patch will be compatible     with the laser, delivering light to a designated region on the patient's skin.   "
154412|NCT01262703|"     To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native     coronary arteries.   "
154413|NCT01262690|"     This study will examine whether a single dose of PF-05230901 is safe and well tolerated when     given to healthy volunteers by injection under the skin. An additional objective is to     measure the blood concentrations of PF-05230901. Each dose will be tested in a different     group of subjects starting from the lowest dose.   "
154418|NCT01262625|"     This randomized, controlled, diagnostic, multicenter trial will compare two diagnostic     imaging pathways--coronary computed tomography angiography (CCTA) and single photon emission     tomography (SPECT) myocardial perfusion imaging (MPI)--to determine the incidence of major     adverse coronary events (MACE), defined as myocardial infarction (MI) or cardiac-related     death, and cross-over to revascularization. CCTA may be used to direct patients with symptoms     of stable angina or angina equivalent to optimal medical therapy (OMT). The use of CCTA as a     diagnostic tool for angina symptoms will be associated with no increase in MACE or     revascularization, decreased cost, reduced risks (e.g., less radiation exposure), additional     insights into alternate explanations of chest pain, and increased cost-effectiveness in     comparison with use of SPECT MPI/invasive coronary angiography (ICA).   "
154400|NCT01262859|"     Induction chemotherapy is gaining momentum in the management of locally advanced squamous     cell carcinoma of the head and neck (SCCHN). The combination of docetaxel, cisplatin, and     5-FU (TPF) was superior compared with PF in a Phase III clinical trials73,74. We have     completed a Phase II clinical trial that showed that docetaxel, cisplatin, and cetuximab     (TPE) is highly active and well tolerated as induction chemotherapy in SCCHN (Argiris et al.     ASCO 2008; A6002). Preliminary survival results are very encouraging. 39 patients were     enrolled and with median follow up 26 months the 2-year PFS was 70% and the 2-year OS 84%.The     combination of chemotherapy plus cetuximab is already a standard treatment in recurrent or     metastatic SCCHN47. Therefore, TPE can be used as the platform for the addition of novel     agents.      EGFR and VEGF are among the most important and validated molecular targets in cancer therapy.     The incorporation of novel targeted therapies to chemotherapy and radiotherapy is of     particular interest in head and neck cancer, and may improve efficacy without significantly     increasing toxicity. A Phase III trial of carboplatin/paclitaxel/bevacizumab with or without     cetuximab in advanced NSCLC has been proposed by SWOG. Bevacizumab is currently being     investigated in SCCHN with promising results. A Phase II study investigating the combination     of pemetrexed and bevacizumab (UPCI 05-002) as well as a Phase II trial of cetuximab and     bevacizumab (UPCI 05-087) in recurrent or metastatic SCCHN are ongoing at the University of     Pittsburgh with encouraging results (ASCO 2008 and ASCO 2009). In this study, 32 have been     already enrolled. There was only 1 patient with grade 3 hemorrhage. The objective response     rate is 20%, the median PFS 2.8 months and the median OS 8.1 months.      In order to further improve the efficacy of TPE and the rate of complete responses we propose     to add bevacizumab to the TPE followed by XPE regimen we developed at the University of     Pittsburgh. Due to non-overlapping toxicities and based on our prior experience we anticipate     that the regimen will be well tolerated. Moreover, we plan to obtain tumor biopsies and blood     samples in the first cycle and evaluate the modulation of biomarkers post combination     therapy. Data from induction with TPE (presented at ASCO 2009) indicate the potential     significance of cytokine levels in patient outcome. Also, we will evaluate the feasibility of     subsequent concurrent radiation, cisplatin, cetuximab and bevacizumab. Patients with stable     disease in the primary could be considered candidates to surgical resection at the discretion     of their physician, if the tumor is resectable.   "
154401|NCT01262846|"     The overall goal of this study is to compare the safety and immunogenicity of trivalent     Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals. Our     hypothesis is that Fluzone® HD will be safe and more immunogenic than the currently used     vaccine   "
154402|NCT01262833|"     The study will address the role of internal pudendal artery disease in erectile dysfunction     (ED), and whether it might eventually be amenable to intervention with stenting. There is     currently a small trial investigating the potential benefit of stenting for erectile     dysfunction, but the relationship between pelvic arterial stenoses and erectile dysfunction     is not yet proven. The investigators intend to perform angiography on patients both with and     without erectile dysfunction, to see whether internal pudendal artery disease is more common     in the population with erectile dysfunction. In addition to angiography, stenoses will be     examined using fractional flow reserve. The degree of internal pudendal artery disease will     then be correlated with the degree of erectile dysfunction using a validated questionnaire,     the International Index of Erectile Function (IIEF). Patients will then complete IIEF     questionnaires for 5 years to assess the relationship between internal pudendal artery     disease and progression of erectile dysfunction.   "
154403|NCT01262820|"     This is an open label Phase II Trial that using the investigational anti-cancer agent,     Pazopanib to see whether non-squamous non-small cell lung cancer will respond to its use by     decreasing the size of the tumor or stopping its growth.   "
154404|NCT01262807|"     This a randomized controlled study to test the hypothesis that patients who perform in-cast     exercises will have superior range of motion immediately post-cast removal, without a     concomitant increase in complication rate when compared with a control group who receives     standard post cast care which does not include the intervention exercises.   "
154405|NCT01262794|"     To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc)     administration of CDP6038 to Japanese subjects.      To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of     CDP6038 to Japanese subjects   "
154406|NCT01262781|"     The obesity epidemic has reached down into the infant and toddler age group. Dietary     indiscretion during pregnancy, particularly in our current food environment, is a major risk     factor for both gestational diabetes and neonatal macrosomia (>4kg newborns), which is itself     a risk factor for obesity and metabolic syndrome in the offspring, possibly even during     childhood. Temporal increases in fructose consumption in the last two decades coincide with     temporal increases weight gain during pregnancy and with increased birth weight, including a     higher prevalence of macrosomic newborns. Our central hypothesis is that higher fructose     consumption during pregnancy is a risk factor for infant obesity and metabolic syndrome.   "
154407|NCT01262768|"     Portion size measurement aids (PSMAs) are tools that facilitate the estimation of food     servings. The objectives of this study are to determine (a) if food portion size estimation     accuracy differs when using a two dimensional (2D) PSMA (actual-size photos called Portion     Size Cards) compared to a 3D PSMA (Portion Size Kit) and (b) whether differences exist in the     short-term usefulness of and satisfaction with these PSMAs in a sample of parents of     overweight children and youth. We hypothesize that the group that receives the 3D PSMAs will     be more accurate in food portion size estimation and will be more satisfied with the tool     compared to the group that receives the 2D PSMAs.   "
154408|NCT01262755|"     DESCRIPTION: Minimal data exists on the prevalence of gastroesophageal reflux disease in     minority populations. Specific objectives of this K24 research project are to: (1) Provide an     estimate of the prevalence of gastroesophageal reflux disease in an urban, African American     population; (2) Determine whether specific risk factors including diet, tobacco use, physical     activity, and psychosocial stress are important in the targeted population. We will also     measure height, weight, and waist/hip circumference to determine the impact of central     obesity on reflux. PUBLIC HEALTH RELEVANCE: This research will help doctors to understand the     frequency and risks for esophageal reflux disease (heartburn) in African Americans.   "
154409|NCT01262742|"     Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the     most commonly uterotonic drug used to prevent and treat PPH in North America, however, there     are some limitations to its use. Oxytocin has a very short duration of action, which requires     a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians     and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of     carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post     partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts     4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater     efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin     has not yet been published.      We hypothesize that a dose-response study will establish the minimum dose of carbetocin     required to produce appropriate contractility in 95% of the women (ED95) undergoing elective     cesarean delivery.   "
154419|NCT01262612|"     In some patients with cancer there are also cancer cells in the abdominal cavity or between     the lung membranes. These cancer cells create too much moisture in the abdominal cavity or     between the lung membranes. If there is fluid in the abdominal cavity (ascites fluid) this     can bring on abdominal distension, abdominal pain, loss of appetite, fatigue, bloating and     sometimes wheezing. Too much fluid between the lung membranes (we call this pleural fluid)     gives breathlessness, chest pain and coughing. The use of diuretics may offer a small group     of patients symptom reduction. Additionally, the fluid can be drained through a needle     puncture or fluid collection (through a biopsy). But usually, the moisture quickly returns.      Previous research done in this hospital with cediranib showed that with some patients with     cancer who suffered from fluid in the abdominal cavity or between the lung membranes, this     moisture reduces while using this drug. It also reduced the symptoms caused by this excessive     moisture.      The current study is conducted to see whether patients with cancer and fluid in the abdominal     cavity or fluid between the lung blades benefit from using cediranib. This involves not only     whether the amount moisture reduces, but also if the complains decrease. In addition, we will     carefully consider the possible side effects of cediranib.   "
154420|NCT01262599|"     Pedicled transverse rectus abdominus myocutaneous (TRAM) flaps are the most common     post-mastectomy breast reconstructive surgeries that utilize the patient's tissue. The     pedicled TRAM flap involves harvesting skin, fat, and muscle from the abdomen to create a new     breast. TRAM flap complications include fat necrosis of the reconstructed breast, delayed     wound healing, and abdominal bulge or hernia. Pain at the abdominal donor site is a major     contributor to the need for four to five days of post-operative hospital stay. Pulsed     electromagnetic field (PEMF) technologies have been useful as adjunctive therapy for the     treatment of delayed union fractures, chronic wounds and post-operative pain. PEMF devices     are economical and disposable, and can be incorporated unobtrusively in standard     post-operative dressings. The investigators have recently reported, in a double-blind,     placebo-controlled study on breast reduction, that post-op PEMF therapy produced a     significant decrease in pain and pain medication use, along with a concomitant decrease in     IL1-beta in the wound bed.      The proposed study seeks to determine whether similar results will be obtained after a     significantly more extensive surgical procedure, like the TRAM flap. Patients scheduled for     pedicled TRAM flap breast reconstruction of a single breast immediately following mastectomy     will be enrolled in this double-blind, placebo-controlled, randomized study. Subjects will be     assigned to one of two groups: a treatment group with active PEMF devices and a placebo group     with sham devices that deliver no PEMF. PEMF and sham devices will be taped over both the     breast reconstruction and abdominal donor sites. Patients will keep the devices in place for     their hospital stay and for a total of two weeks. The investigators hypothesize that subjects     in the PEMF treatment group compared to placebo will have a faster reduction in pain, take     less pain and nausea medications, have lower levels of IL1-beta in wound exudate, have a     shorter hospital stay, and have less wound-healing complications.   "
154421|NCT01262586|"     This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles     between vildagliptin and glimepiride.   "
154422|NCT01262573|"     This study compares outcomes among patients having a total laparoscopic hysterectomy. This     involves removing the uterus and cervix using a laparoscopic or keyhole technique. The top of     the vagina is routinely sutured closed after this procedure and this study is comparing two     different suture materials for this purpose. One suture material is a barbed suture that has     the advantage of maintaining good tension and closure on the wound. The other is a standard     smooth suture that is commonly used for this procedure. The investigators are comparing the     time it takes to close the vaginal cuff, as well as bleeding after surgery and the healing of     the top of the vagina.   "
154424|NCT01262547|"     This study evaluates micrografting using a harvesting and grafting process that has been     designed by Momelan Technologies. The overall concept is to harvest several small pieces of     skin, each measuring about 1.75 mm in diameter from a normal pigmented area using a     commercially available suction blister device, adhere them to a sterile elastomeric substrate     and is then place it on a recipient area prepared by epidermal dermabrasion (removal of the     epidermis).   "
154443|NCT01262300|"     This is an ancillary study to a randomized controlled trial of high dose vitamin D in older     long-term care residents (NCT01102374). In this study, a subset of trial subjects will     receive the zoster vaccine and we will determine the immunological response to the vaccine in     this older, frail population, as well as the association between vitamin D and immunological     outcomes.   "
154425|NCT01262534|"     The purpose of this study is to assess the clinical profile of patients with moderate to     severe psoriasis in Spain. The primary objective is to analyze the clinical profile of     patients with moderate to severe psoriasis, as defined by a set of conditions (obesity,     hypertension, diabetes, abnormal amounts of lipids in the blood, cardiovascular disease,     etc.) and its correlation to the patients' quality of life. The secondary objectives are to     describe the demographic characteristics and habits of the patient, to evaluate the clinical     characteristics of the disease, and to describe the diagnostic and therapeutic procedures     being used in standard clinical practice and the patients' expectations for these therapies.   "
154426|NCT01262521|"     An expanding number of studies suggest a therapeutic role for nitrate and nitrite, most     notably in treatment and prevention of cardiovascular disease including ischemia-reperfusion     (IR) injury and hypertension. The nutritional aspects of these cardioprotective effects are     particularly intriguing since nitrate and nitrite are abundant in our everyday diet.      Whether increasing the circulating pool of nitric oxide and nitrite by dietary nitrate offers     a novel mechanistic approach to regulate mobilization of circulating angiogenic cells and     thus regenerative processes in cardiovascular medicine is not known. Thus, in the present     study, we tested whether oral application of nitrate leads to an enhanced number of     circulating angiogenic cells and whether this is associated with an improvement in     endothelial function.   "
154427|NCT01262508|"     Hemodynamic monitoring in hospitalized patients is crucial since in clinical practice     unexpected deterioration of cardiovascular function remains a serious problem and an     important cause of death. Novel perspectives in reflex testing of the autonomic nervous     system might be useful to protect some patients from cardiovascular events by detecting     cardiovascular deteriorations. In addition, standard pulse oximetry in low acuity settings is     nowadays predominately used to monitor peripheral oxygen saturation. Of note, there is     evidence that additional analyses of pulse wave characteristics might be a valuable source of     information to generate additional insights into the cardiorespiratory status of the patient.     Herein, we aim to develop novel algorithms in order to protect in-hospital patients from     cardiovascular events in consequence of hemodynamic instability in the future.   "
154428|NCT01262495|"     we will use testicular tissue from patient who underwent orchidectomy due to medical reasons     and test the viability of the tissue after cryopreservation and de-freezing.   "
154429|NCT01262482|"     In Spain, the gastric carcinoma is the 5th most frequent malignant tumor in women and the 6th     in men, and represents the 3rd cause of cancer-related deaths amongst women and the 4th     amongst men. The average of 5-year survival rate in Spain is under 30%. The main reason of it     is that, despite carrying out an adjuvant treatment, more than the 50% will present relapsed     disease.      Sorafenib has been the first RAF inhibitor, both of RAF-1 and B-rRAF and its b-RAF variant     V600E. Moreover, it has shown its ability to inhibit other tyrosin-quinase receptors as VEGFR     2 and 3, c-kit, Flt-3 or PDGFR. Its activity has been clearly proven in clear cell renal     carcinoma.      The mechanism by which Sorafenib seems to act is not because of the existence of a mutation     of RAS or RAF, but because as there is a VHL shortage the HIP produces a VEGF, bFGF or TGF     overexpression that produces in turn a hyper-stimulation on the RAF/ERK/MEK pathway.      The RAF/MEK/ERK pathway and angiogenesis seem to be clearly involved in the gastric carcinoma     tumorigenesis and progression. Because of that, it seems interesting to associate Sorafenib     to an oxaliplatin-based chemotherapy, which has shown its effectiveness in relapsed patients     after receiving cisplatin-based schemes. Moreover, there is a phase 1 trial confirming the     tolerance of the oxaliplatin and Sorafenib association, describing partial responses amongst     gastric cancer patients previously treated with cisplatin.   "
154430|NCT01262469|"     GERICO 09/0907 is a Phase II multicentric trial evaluating the toxicity and activity of the     combination of lapatinib and capecitabine in locally advanced or metastatic breast cancer     over expressing HER2 for patients aged ≥ 70 who have failed after one line of chemotherapy in     combination with trastuzumab.      Due to the minimal participation of older people in clinical trials, there is a lack of data     to make evidence-based decisions regarding chemotherapy in this indication.      The study is designed to investigate whether elderly patients with locally advanced or     metastatic breast cancer over-expressing HER2 could take advantage of the combination     lapatinib and capecitabine in term of clinical benefit, and with no adverse effects and no     detrimental impact on functional status (part of geriatric assessment).      The main objective is to assess clinical benefit (defined at 4 months as complete response,     partial response or stable disease), safety and preserved geriatric independence (main     objective is a bi-criteria or composite criteria).   "
154431|NCT01262456|"     The purpose of this trial was to confirm/establish long-term safety and efficacy of     desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further     evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.   "
154432|NCT01262443|"     The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial     flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual     success of the procedure.   "
154444|NCT01262287|"     The purpose of this study is to evaluate whether dutasteride is safe and effective for     reducing alcohol use in male drinkers who want to stop or reduce their drinking. The     investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and     that, compared to placebo treatment, dutasteride will result in a greater reduction in the     amount of alcohol consumed per week. The study sample size is of a pilot scale and is     designed to provide additional support for the study hypothesis and provide an estimate of     likely effect sizes in order to design a more definitive study.   "
154445|NCT01262274|"     The Aim of this study is to validate a treatment of anastrozole in combination with     tegafur-uracil as pre-operative therapy for postmenopausal primary breast cancer. Although     pre-operative hormone therapy is a novel therapeutic approach, only hormone therapy has     limitation in terms of efficacy. Metronomic chemotherapy, which is the frequent     administration of low-dose cytotoxic agents, is not only target tumor cells but also     inhibiting angiogenesis. Because there was a report that efficacy of hormone therapy add to     metronomic chemotherapy as pre-operative therapy, a randomized phase II trial of anastrozole     (ANA) in combination with/without metronomic tegafur-uracil (UFT) as neo-adjuvant for     postmenopausal breast cancer will be conducted.   "
154433|NCT01262430|"     The OtisMed Custom-fit system for total knee replacements replaces conventional surgical     techniques for templating and intra-operative instrumentation with a preoperative virtual     surgery process that utilizes 3D models of the affected knee from a pre-operative MRI or CT     image. The 3D model of the affected knee is processed with a proprietary algorithm that     virtually alters it to its pre-arthritic state by filling articular defects, removing     osteophytes, and approximating the joint surface. The software then shape matches the knee     replacement femoral and tibial components to the preathritic knee model and aligns the     femoral component to the functional flexion-extension axis of the femur. The final     preoperative step is the machining of custom biocompatible plastic cutting blocks that fit     the arthritic knee. These cutting blocks are used during the knee replacement surgery to     guide the bone cuts so that the replacement components are aligned for the individual     patient.      In this study we propose to compare patients who have received total knee replacement     components with the OtisMed Custom-fit procedure to those who have had the same components     implanted in the conventional manner with Computer Assisted Surgery (CAS). The primary     outcome will be micromotion of tibial and femoral implants at 1 and 2 years after surgery.     Secondary outcomes will include subjective outcomes, accelerometric gait analysis, bone     mineral density, full leg alignment, change in intra-operative frontal plane alignment,     intra-operative deviations from the surgical plan, surgery duration, OR turnover time, number     of instrument pans used, and length of hospital stay.   "
154434|NCT01262417|"     The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for     the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer     requiring two-stage surgery for the resection of hepatic metastases.      Eligible patients will be randomly assigned to one of 2 arms:        -  Seprafilm group (receiving resorbable barrier membrane during the first surgery)        -  No-treatment control group (without seprafilm barrier during the first surgery)      The primary objective is to establish, in patients with colorectal cancer requiring two-stage     surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier     membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the second     operation.      This study is a prospective multicentric phase II, controlled, randomized and non comparative     trial.      A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be     assigned to the no-treatment control group. The inclusion period should be approximately 18     months. The follow up period after the second surgery will be 3 years.   "
154435|NCT01262404|"     Three groups of subjects are trained to practice mindfulness meditation, compassion     meditation, or attend a health training control class. Individuals from each group will     undergo structural and functional brain imaging before and after training. The hypothesis is     that the compassion meditation group will show the largest changes in brain structure and     function. In a second series of experiments, the subjects practicing a Tibetan meditation     practice will be undergo MRI thermometry imaging to construct detailed three dimensional     temperature maps of their bodies before, during, and after they perform this practice.   "
154436|NCT01262391|"     This single-dose study will investigate how well solifenacin suspension is taken up, how long     it stays in the body and how well it will be tolerated in children and adolescents aged 5-17     years with symptoms of overactive bladder.   "
154437|NCT01262378|"     Prospective, non-randomized, controlled study to investigate the clinical outcome of surgery     using the Harmonic knife vs the HF knife in patients requiring abdominoplastic surgery or     body lift (Lockwood)   "
154438|NCT01262365|"     The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the     treatment of subjects with Systemic Lupus Erythematosus (SLE)   "
154439|NCT01262352|"     The purpose of this study is to evaluate the effect of ivacaftor (VX-770) on lung clearance     index (LCI) in subjects aged 6 years and older with cystic fibrosis (CF) who have the     G551D-CFTR mutation on at least 1 allele.   "
154440|NCT01262339|"     Primary focal hyperhidrosis (excessive sweating) is a debilitating condition affecting     approximately 3% of the population in the United States. Not only that it is a major social     embarrassment to affected individuals, it also has significant negative impacts on career,     school, and relationship. Botulinum toxin A (BTX-A), a sterile neurotoxin purified from     Clostridium bacteria, was approved by the U.S. Food & Drug Administration in 2004 for the     treatment of severe focal axillary hyperhidrosis that does not respond to topical     antiperspirants. It is becoming a promising treatment for many patients suffering this     condition. Over the past decade, the medication has also been used effectively for many other     forms of focal hyperhidrosis such as the hands, feet, forehead, scalp and groin.     Unfortunately, BTX-A injection for primary focal hyperhidrosis of the palms and soles are     often limited by pain and post treatment muscle weakness associated with the procedure.     Recent studies have demonstrated that BTX-A can be delivered across the skin via electric     current using a medical device, called iontophoresis (FDA 510(k) clearance # K042590 or     Phoresor IIPM700). Studies with limited number of patients have demonstrated promising     results with this new treatment.   "
154441|NCT01262326|"     All subjects will be evaluated by the Research Nurse at the Clinical Translational Research     Center (CTRC) Outpatient Clinic to obtain informed consent, a brief medical history, weight,     body mass index, waist/hip circumference and vital signs. Additionally, blood will be drawn     at this visit to screen for renal dysfunction (Chem 10), liver disease (liver function tests     (LFT's)), thyroid dysfunction (TSH), diabetes mellitus (HbA1C), and chronic inflammatory     states (erythrocyte sedimentation rate). Subjects recruited to the study will be placed on a     low-carbohydrate diet (<20 g/d without caloric restriction) designed either to promote weight     loss or maintain weight stability for fourteen days prior to the protocol or they will     consume a typical Western diet designed either to promote weight loss (restricted by 1300     kcal/d in the final fourteen days) or maintain weight stability for twenty-one days. Subjects     recruited to the study will be lean, overweight, or obese and also may carry a diagnosis of     NAFLD. Target accrual for total enrollment for this project will be set to 80 subjects to     accommodate attrition and screen failures. The details of the low-carbohydrate diet have been     discussed in consultation with Linda Brinkley, nutrition staff of the CTRC. Subjects chosen     to undergo carbohydrate-restriction will have a teaching session with a CTRC dietician.     Subjects will then initiate dietary carbohydrate-restriction on their own and keep a daily     dietary record for seven days. At the end of seven days, the dietary record will be analyzed.     The CTRC will then prepare all meals for the final seven days of the diet in accordance with     daily caloric intake calculated from the dietary record. Calorie-restricted participants will     keep a dietary record for one week while eating a typical Western diet. The dietician will     analyze this record and meals restricted by 1300 kcal/d will be prepared by the CTRC for the     final fourteen days of the diet. Alternatively, some subjects eating a typical Western diet     may consume prepared meals with a fixed content of carbohydrate, fat, and protein that is     unrelated to their pre-study dietary intake. In this scenario, the dietary carbohydrate     content may be varied between 30 and 60% to provide information on differences in hepatic     metabolism under conditions of differing, but clinically sustainable, carbohydrate intake.     All participants will be admitted to the CTRC the night prior to the study and begin an     overnight fast after dinner. Between 18:00 and 09:00, subjects will receive two stable     isotope tracers orally: [U-13C]propionate at 08:00 (three 400 mg doses given over 1 hour) and     70% 2H2O at 22:00, 02:00, and 06:00. During the study subjects will also be given 0.5% 2H2O     ad libitum. Two 500 mg acetaminophen tablets will also be given at 08:00. Between 08:00 and     09:00 subjects will undergo measurement of their respiratory quotient (RQ) using the CTRC     indirect calorimeter (Delta Trac II).. Subjects will then have an intravenous catheter placed     and an infusion of tracer amounts of [3,4-13C2]glucose, [1,2-13C]β-hydroxybutyrate and     [3,4-13C]acetoacetate will be initiated. At 1 ½ and 2 hours after initiation of the infusion,     a 50 cc blood draw will be performed. Voided urine will be collected every hour after     ingestion of acetaminophen until the protocol concludes. The subject will then be given a     meal and discharged from the CTRC, marking the completion of the protocol. The collected     blood and urine will be transported by the research coordinator to the Advanced Imaging     Research Center lab for analysis by MRS. Another blood draw (approximately 10 cc) will be     done in conjunction with the final MRI in order to measure changes in the lipid profile after     the diet intervention. The visits in their entirety will be as follows:      1 screening visit: 20 minutes        1. dietician visit: 20 minutes        2. MRS visits: 45 minutes each      1 (optional) overnight visit: 20 hours   "
154442|NCT01262313|"     There remain important barriers to the translation of the programs like the Diabetes     Prevention Program to public health. There is a lack of established lifestyle intervention     programs as they are resource and time intensive, exceeding both the resources and the     training of most primary care providers. A solution may be the implementation of lifestyle     intervention programs in the community setting that are unrelated to primary medical care. A     community based program at a public facility may extend the reach of lifestyle intervention     to those unable to obtain these services from an established medical facility. Community     lifestyle intervention to modify dietary, physical activity, and behavioral factors may be a     promising strategy for weight management and the reduction of risk for metabolic disease. In     this validation study we will assess pre and post intervention to identify whether measurable     changes can be detected in body weight, body composition, markers of metabolic disease and     quality of life after participation in the Healthy Creations, a community based lifestyle     intervention program presented by Center Court Fitness Center of the Grand Forks Park     District and Altru Health System.   "
154456|NCT01262131|"     The purpose of this study is to see if a device called the Resonator can help to reduce pain     and improve aspects of health and quality of life for people with fibromyalgia.   "
154446|NCT01262261|"     Probuphine (buprenorphine implant) is an investigational implant placed just below the skin     containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a     6-month, open-label, re-treatment study that will confirm the safety and efficacy of     Probuphine in patients who have previously completed the 6-month PRO-806 study with either     Probuphine, placebo or sublingual buprenorphine.   "
154447|NCT01262248|"     Recent studies have shown that narrow-band imaging (NBI) is a powerful diagnostic tool for     the differentiation between neoplastic and non-neoplastic colorectal polyps. The aim of the     present study is to develop and evaluate a computer-based method for automated classification     of small colorectal polyps on the basis of vascularization features.In a prospective study     207 polyps with a size of 10mm or smaller should be detected by a zoom NBI colonoscopy. These     polyps were imaged and subsequently removed for histological analysis. the polyp images were     analyzed by a computer algorithm. The proposed computer-based method consists of several     steps: preprocessing, vessel segmentation, feature extraction and classification. The results     of the automatic classification (sensitivity, specificity, negative predictive value,     positive predictive value and accuracy)were compared to those of human observers, who were     blinded to the histological gold standard.   "
154448|NCT01262235|"     This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at     multiple clinical centers. The study is designed to determine the safety, tolerability and PK     of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to     standard therapy or for whom there is no standard therapy. After the determination of the     maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with     refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.   "
154449|NCT01262222|"     The purpose of this study is to look at a new method for finding out if patients have a risk     of heart complications from surgery. At the present, to find out if patients have a risk of     heart complications from surgery, look at whether the patient has heart disease, diabetes,     kidney problems, and stroke. The investigators hope that this study will confirm a new, safe     test to help us predict the risk of surgery.   "
154502|NCT01261533|"     The purpose of this study is to determine the feasibility, primary safety and efficacy of     foldable capsular vitreous body (FCVB) in the treatment of retinal detachment, based on the     multi-center clinical trial.   "
158723|NCT01206348|"     To determine if a combination of three currently approved acne products are safe and     effective for the treatment of moderate to severe acne   "
154450|NCT01262209|"     Our team is interested in what can be done to improve the functioning of patients who suffer     from glaucoma, a chronic and irreversible eye disease. Patients with vision loss as a result     of this disease may feel like they have been 'given up on', or lost to our medical system     when no further interventions can be offered to treat their eye disease. It is our intent to     investigate what alternatives we can provide our patients, instead of simply saying, 'nothing     more can be done'. We have learned from studies done on other chronic eye diseases, like age     related macular degeneration, that low vision rehabilitation can improve visual function.      What exactly is low vision? It can involve a loss of visual acuity, making activities such as     reading or writing a challenge; it can involve loss of contrast sensitivity, making shapes     and edges hard to discern, like those of a stair edge, or person's face. It could also     involve a loss of peripheral, or side vision which is a symptom common to most glaucoma     patients. Whatever the cause of low vision, doing day-to-day activities can become     increasingly difficult, and many suffer from a loss of their independence and may even become     depressed. Low vision rehabilitation involves helping patients to use their remaining vision     in optimal, and sometimes even new, ways. This involves an assessment of a person's baseline     vision, and an idea of what their needs are. Patients are then given low vision aids (such as     magnifiers, telescopes, video screens which magnify images, and other tools) as well as     instructions and support for adapting to living and functioning with altered vision.      Although there currently exists no cure for glaucoma, and we are certainly not promising a     reversal of the damage done to the eyes from this chronic disease, we do believe that these     types of rehabilitation services may offer some hope and potential visual benefit to patients     living with vision loss. Our hypothesis is that the use of state-of-the-art low vision aids     in patients with advanced glaucomatous visual loss will provide an improvement in visual     tasks and thereby an improvement in quality of life.   "
154451|NCT01262196|"     MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to     enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a     pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation     characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will     evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic     acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse the     lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby     prevent and reduce the duration of organ failure and improve outcome in these patients.   "
154452|NCT01262183|"     For esophageal cancer that can not be removed by surgery, the choice of treatment is a     combination of chemotherapy and radiotherapy. We call this combination- (or concurrent)     chemoradiotherapy. Chemotherapy is treatment with drugs that kill cancer cells. Both     chemotherapy and radiotherapy make the tumour smaller and enhance each other's effect. The     goal of treatment with chemotherapy and radiation therapy is to cure the cancer.     Unfortunately only a small proportion of patients are cured with this treatment.      Improvements in the outcome of treatment may be expected by using the so-called targeted     treatments. With esophageal cancer, a protein (the epidermal growth factor receptor (this is     a kind of trap), the EGFR), is present in many tumours. This protein causes the tumor to     grow. Panitumumab is a drug that blocks the functioning of this receptor (catcher), so that     possibly the growth and spread of esophageal cancer is prevented.      The main objective of this trial is to see if survival of patients with inoperable esophageal     cancer improves as panitumumab is added to standard treatment with chemoradiotherapy.      It will also investigate whether patients tolerate the addition of panitumumab to the     standard treatment. Also, the biological characteristics of the tumor will be examined. In a     proportion of patients it will be determined how the enhancement of the cancer is visible on     an FDG-PET scan before the start of treatment and how this changes during the treatment. It     will be also be evaluated how this treatment affects the survival.   "
154453|NCT01262170|"     A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety     and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily     reducing the desire to smoke   "
154454|NCT01262157|"     Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of     new blood vessels. The investigators hypothesized that LISW therapy could improve the     symptoms of patients with erectile dysfunction resulting from a problem of blood supply that     do not respond to oral therapy (PDE-5 inhibitors).   "
154455|NCT01262144|"     Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease     is identified are not usually eligible for surgery. PET-CT is used to support staging.     However, some patients received surgery after staging and subsequently require     radio/chemotherapy due to findings on operation.      This study will attempt to find a correlation between SUV-Max on PET-CT and subsequent     outcomes i.e. need for adjuvant therapy.   "
154459|NCT01262092|"     This study involves inducting treatment seeking opioid dependent participants onto     buprenorphine. Once the participant reaches a stable dose they will receive either placebo or     gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant     undergoes a 10-day buprenorphine detoxification.   "
154460|NCT01262079|"     This is a specimen collection protocol designed with the purpose of understanding the immune     responses to influenza in children and adult subjects through collection of blood specimens     and influenza medical history data. This protocol will allow the investigators to evaluate     influenza-specific immune responses to a variety of influenza strains in a broad age range of     the U.S. population early and late in the 2010-2011 influenza season. Immune responses will     be evaluated using blood samples. The underlying hypothesis for this protocol is that the     detailed characterization of immune responses to influenza in subjects from different age     groups will further the understanding of immune responses cross-reactivity and advance     development of influenza vaccines that are cross-reactive against old, new and re-emerging     influenza strains.   "
154497|NCT01261598|"     The poor prognosis in the early-stage of lung cancer is due to potential worsening of the     disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual     treatments.      FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose     consumption. Then, this exam is used for pathology staging, target volume definition for RT,     and treatment efficiency few months after RT or CRT. Our assumption is that an FDG-PET exam     during the course of the RT or CRT might be predictive of the treatment efficiency few months     later.      In this study, the investigators propose to perform 4 FDG-PET: first PET1 before     radiotherapy, second PET2 during the radiotherapy (see RTEP1), third and fourth PET3     PET4 3month and 12 month after the therapy.      The investigators will investigate the performances of FDG-PET performed during the RT or CRT     for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is     confirmed, the investigators would be able to optimize the planning treatment during the     course of the therapy.   "
160853|NCT00000293|"     The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use     in depressed and non-depressed females with cocaine abuse/dependence.   "
154461|NCT01262066|"     A number of psychosocial risk factors have been strongly related to a range of health     problems (chief among them CVD). Clinical research has shown that behavioral interventions     have enormous promise to ameliorate the psychosocial distress, the health-damaging effects     and the costs associated with these risk factors. However, few such programs have been     implemented in a large-scale way. Corporations are increasingly interested in providing such     services for their employees, but they have encountered difficulties in knowing which     programs are most effective. Until these programs are developed as products that can be     tested and shown to produce consistent benefits, dissemination of these beneficial programs     will be hindered. Taken together, these findings make a strong case that the development of a     standardized, protocol-driven behavioral intervention package that can be delivered in a wide     range of corporate settings presents a remarkable commercial opportunity. The overall goal of     this SBIR Fast-Track-funded project is to gain empirical evidence in a RCT that documents the     effectiveness of the Williams LifeSkills Workshop (a protocol driven 6-session workshop) in     reducing BP, psychosocial risk factors, and promoting positive health outcomes in a cost     effective manner in a corporate setting. This empirical support, tested in a setting     independent of the program developers and by an experienced research team, will then be used     to help market the product in the corporate wellness marketplace. It is hypothesized that     participants (employees in an urban medical center) in the LifeSkills intervention will     experience greater reductions in blood pressure and improvements in measures of psychosocial     well-being than those receiving usual medical care and given educational materials on     reducing BP.   "
154462|NCT01262053|"     With the increased adoption of CPOE systems, it is important to recognize that design flaws     have resulted in the creation of new types of iatrogenic medical errors. An example of a new     type of iatrogenic medical error introduced by CPOE systems has been named juxtaposition     errors. Juxtaposition errors, as defined by Ash, et al. are errors that can result when     something is close to something else on the screen, and the wrong option is too easily     clicked in error. Juxtaposition errors can lead to a patient receiving a medication, a test,     or a treatment intended for another patient, sometimes with dire consequences. Juxtaposition     errors are likely a subclass of a broader group of wrong-patient CPOE errors that have     multiple etiologies.      The primary objectives of this research proposal is to investigate the prevalence of     wrong-patient near miss CPOE errors, to investigate the root cause of these errors, and to     investigate and compare the efficacy and workflow impact of two distinct interventions to     prevent these errors.   "
154463|NCT01262040|"     The purpose of this study is to determine whether narrowband imaging (NBI) makes it easier     for a surgeon to see cancer.      NBI is a kind of light. Normally, white light is used during surgery. White light uses many     wavelengths of light. NBI only uses two wavelengths which highlight the blood vessels. This     makes it easier for the surgeon to see blood vessels. Tumors often have more blood vessels     than normal tissue. As a result, NBI may make it easier for the surgeon to see small tumors.      In this study the surgeon will look with both normal white light and NBI. This way a     comparison can be made to determine which is superior.      Improved identification of tumors allows doctors and patients to make informed decisions     about whether treatment is needed after surgery. It also provides additional information to     determine which treatments may be best.   "
154464|NCT01262027|"     The goal of this clinical research study is to learn if dovitinib can help to control     inflammatory breast cancer. The safety of this drug will also be studied.   "
154465|NCT01262014|"     Given the low Responses Rates and short survival times achieved with conventional cytotoxic     agents in resistant ovarian cancer patients, new treatment options are needed in this patient     population.Antiangiogenic therapy has an important role in this group of patients and     Pazopanib in particular. We are going to study if Pazopanib is able to control     disease-related symptoms minimizing the side effects of treatment. This aspect is very     important in the treatment of resistant ovarian cancer patient since our treatment is     palliative without any impact in overall survival. So our goal is to study the Clinical     Benefit Rate (objective responses plus stable disease rates) achieved with Pazopanib and its     toxicity profile in this subgroup of patients   "
154466|NCT01262001|"     To evaluate the safety and tolerability of FG-3019 in subjects with Idiopathic Pulmonary     Fibrosis (IPF) and the efficacy of FG-3019 for attenuating fibrosis in these subjects.   "
154467|NCT01261988|"     The primary objective of the study is to assess the safety and adhesive performance of the     VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by     healthy volunteers.   "
154468|NCT01261975|"     The objective of this study is to test the hypothesis that the time to reach a stable     refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision     compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision     Enhancement System.   "
154488|NCT01261715|"     Two of the more frequently used options for skin closure following a cesarean delivery     include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin     adhesive. This method of closure is used less frequently than either staples or sutures.      Few studies have been done regarding whether Dermabond is preferable or affect the outcome of     a cesarean section surgery. The aim of our study is to find weather Dermabond haas better     result for the closure of cesarean section wounds.   "
154498|NCT01261585|"     Study of the modification of the fixation(binding) of Fluoro-2-deoxy-D-glucose (FDG),     fluoro-misonidazole (FMISO) and 3'deoxy-3-fluoro-thymidine deoxy-3-fluoro-thymidine (FLT)     measured in tomography by broadcast(emission,issue) of positrons (PET) at patients before and     in the course of exclusive radiotherapy or concomitant radiochemotherapy for primitive     bronchial cancer.      This protocle allows to study the simultaneous variations of the metabolism, the hypoxie and     the cellular proliferation by PET SCAN at 5 patients reached(affected) by a primitive     bronchial cancer in the course of exclusive radiotherapy for primitive bronchial cancer not     small cell lung.      The investigators are also going to study several scenarii of optimization of the     radiotherapy according to the variations of the tumoral metabolism, the hypoxie and the     cellular proliferation measured in the course of radiotherapy (theoretical study on console     using the scanner and the various examinations).   "
154499|NCT01261572|"     To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in     patients with prostate cancer.   "
154469|NCT01261962|"     In leukocytes of patients undergoing adjuvant chemotherapy for colon cancer treatment:     a)identify genes modulated by oral supplementation of zinc; b) evaluate the effects of oral     zinc supplementation on humoral immunity and neutrophil function. The study will be conducted     on 30 adult patients aged grater than 18 years, of both genders who have undergone surgical     resection of colonic neoplastic lesions without metastatic lesion. Patients will be     randomized into two groups, with the first (Group QT Zn, n = 15) receive 70 mg/d of zinc for     16 weeks and the second will receive placebo (QT Placebo Group, n = 15). The study will also     include 30 healthy volunteers who receive supplementation of 70 mg/d of Zn (C Zn group, n =     15) or placebo (Group C Placebo, n = 15). Zinc supplementation or placebo for all study     groups will start two days before the volunteers received the pneumococcal vaccine,     polyvalent 23. Fifteen days after vaccination, patients begin chemotherapy as pre-established     criteria by the Oncology Service. Will be monitored the parameters of nutritional status     (anthropometry, bioelectrical impedance, food intake, and laboratory tests) adverse effects,     according to rules of the CTCAE. In the evaluation of humoral immunity, antibodies     opsonization and in the pneumococcal polysaccharide will be measured. Will be evaluated the     function of neutrophils by measuring DNA NETs and quantified calprotectin and elastase     released in the culture supernatants of activated neutrophils. RT-qPCR will be done of genes     differentially expressed(DEGS) on activated leukocytes. In six volunteers from each group     will be analyzed global gene expression from RNA extracted from leukocytes by microarray;     will be detected and correlated the molecular pathways modulated by zinc by MetaCore software     (GeneGo). The DEGS will be validated by RT-qPCR.   "
154470|NCT01261949|"     Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by     hearing loss and leading to the phantom auditory perception of sound in the absence of an     external or internal acoustic stimulus.   "
154471|NCT01261936|"     Menorrhagia is the term used to define excessive menstrual blood losses, as often based on a     subjective judgment of women. Many arbitrary values, expressed in milliliters of blood, have     been proposed to define this symptom: 60 on each cycle has also been confirmed in our     preliminary study on 87 healthy women. The quantitative determination of menstrual blood     losses is nevertheless rarely performed, only in research settings. Although menorrhagia is a     quite frequent symptom in healthy women apparently haemostatically competent in the fertile     age (20-30%), its incidence becomes very high in women affected by congenital coagulation     factors deficiency and (50-62.9%) inherited platelet defects, e.g. Glanzmann's     Thromboasthenia (GT); also in von Willebrand Disease the bleeding symptom menorrhagia has     an high prevalence (60-75%)(8); for GT an incidence of 90% has been reported.      This explains the need for a study focused on the evaluation of menorrhagia in CBDs,     addressed to answer to the following, still unsolved questions:        1. Definition of the entity of menstrual blood losses in women affected by CBDs        2. Elaboration of specific treatment schedules for each type of CBD        3. Impact of different specific treatment schedules on kinetic and entity of menstrual          losses (how does treatment modify losses?).   "
154472|NCT01261923|"     This study aims to investigate whether liver patients may tolerate alitretinoin by comparing     metabolism in 8 such patients with the metabolism in 8 healthy controls   "
154473|NCT01261910|"     The primary purpose of this study is to test different methods by which kidney transplant     centers can educate potential transplant candidates about living donor kidney transplant     (LDKT).      The most effective ways to educate kidney transplant candidates about LDKT remain unclear.     The goal is to determine, among a diverse cohort of potential kidney transplant candidates,     whether a transplant center-based intervention will increase understanding of the     opportunities for and process, risks, and benefits of living kidney donation and LDKT. The     investigators hypothesize that kidney transplant candidates' understanding of living kidney     donation and LDKT will be increased by interventions implemented at the transplant center on     the day of transplant evaluation.      The investigators propose a single-center, 2-arm, cluster-randomized, controlled trial to     compare the effects of two educational strategies upon transplant candidates' understanding     of living kidney donation and LDKT:        1. Usual transplant education implemented by the transplant center, on the day of the          transplant evaluation (standard care); and        2. Intensive initial transplant education implemented on the day of the transplant          evaluation.      Intensive initial transplant education will utilize videos of living donors' experiences as     well as a session with a trained Transplant Educator, who will focus upon living donation     education. One week after the transplant evaluation day and 3 months later, the investigators     will assess transplant candidates' knowledge of LDKT (using questionnaires), identify     correlates of increased understanding of LDKT, and assess racial/ethnic differences in the     understanding of LDKT.   "
154474|NCT01261897|"     The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and     morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor     -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total     knee arthroplasty.   "
154475|NCT01261884|"     Preeclampsia and other high blood pressure disorders of pregnancy are a significant cause of     both maternal and fetal complications of pregnancy. To date, there is no known cure for     preeclampsia, but studies have shown that exercise may lower the risk of preeclampsia and     high blood pressure disorders in pregnancy. Resistance training also lowers blood pressure,     and may be easier to perform in a pregnant population, leading to higher compliance. The     investigators propose to perform a novel prospective study of a resistance training regimen     on blood pressure in pregnant patients at high risk for developing preeclampsia or high blood     pressure.   "
154476|NCT01261871|"     The purpose of this study is to measure pressures within the eye (during surgery to remove     the prostate or abdominopelvic masses) as the body position required for these laparoscopic     procedures has been associated with increases in pressure within the eye.   "
154496|NCT01261611|"     The purpose of this study is to evaluate how well a new drug called Dysport RU works and how     safe it is, when it is used for the treatment of cervical dystonia. Dysport RU will be     compared to an approved drug called Dysport.   "
154511|NCT01261416|"     The primary objective of this study is to determine the pharmacokinetic profile of a loading     dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm     infants with seizures. Secondary objectives are to evaluate the safety and efficacy of     levetiracetam in term and preterm infants with seizures.   "
154477|NCT01261858|"     Median sternotomy has been the standard incision for coronary artery bypass grafting (CABG)     in patients undergoing surgery for coronary artery disease. Given the increasing risk profile     of contemporary cardiac surgery patients, sternal complications are subject to increase     concomitantly. Despite advances in many areas of cardiac surgical procedures, innovation in     sternal closure technique has been lacking and postoperative complications remain. In this     study, the investigators aim to assess the effectiveness of using a novel osteoconductive     biologic bone cement (KryptoniteTM, Doctors Research Group Inc.) as an adjunct to     conventional sternal closure in post CABG patients having median sternotomy.      The outcomes of interest for this study will include: pain, discomfort, lung function, wound     healing and analgesic use. The investigators assume that the use of KryptoniteTM will     decrease postoperative pain leading to improvement in postoperative lung function. This may     also lead to improvement in patient recovery and decrease in postoperative complications.      The investigators will undertake a single-blinded randomized, controlled study consisting of     patients undergoing elective coronary artery bypass grafting (CABG) randomly assigned to     either Group A (usual closure with stainless steel wires) or Group B (usual closure with     stainless steel wires plus application of bone cement). Each group will consist of 64     patients in a total of 128 patients. Lung function data using a spirometer will be collected     preoperatively and 3rd and 5th postoperative days as well as in outpatient clinic. Pain data     will be collected on the 1st to 5th postoperative days.   "
154478|NCT01261845|"     BACKGROUND: A proper understanding of the attitudes towards its own health status and concise     estimates concerning the health seeking behavior of the different subgroups of a population     are highly desirable. The structure of the Austrian population with regard to its age     distribution and the proportion of people with immigrant backgrounds have been rapidly     changing in recent years. Questions of allocating limited resources and meeting the needs of     under-served populations have become increasingly important. However, data that could     illuminate these issues are sparse and therefore obtaining them will be important for making     sensible policy decisions.      METHODS: A telephone survey of the Austrian population for the assessment of the occurrence     of any health complaint and the subsequent help seeking behavior with special emphasize on     under-served minority groups - migrant population, elder people, and female gender.      AIMS: Our analysis of the data obtained should help to clarify some hitherto undocumented     aspects and should provide the evidence for building a better health care infrastructure with     equality of access and efficient coordination. We also hope that this information can help to     allocate resources strategically according to needs and cost-efficiency in health care.   "
154479|NCT01261832|"     Current antiplatelet therapy in acute coronary syndrome have a focus on the dual antiplatelet     therapy including aspirin and clopidogrel. However, the patient's drug resistance of aspirin     and clopidogrel is the important cause of poor clinical prognosis. Therefore, recently,     clinical research about the triple antiplatelet therapy including cilostazol is actively     conducted. But, clinical research about triple antiplatelet therapy for acute myocardial     infarction is inadequate situation, and the ideal duration of triple antiplatelet therapy has     been actively discussed. Therefore, we try to evaluate the clinical outcomes of triple     antiplatelet therapy in acute myocardial infarction patients undergoing percutaneous     intervention with drug eluting stent compared with dual antiplatelet therapy and investigate     ideal duration of triple antiplatelet therapy through this research.   "
154480|NCT01261819|"     The study aimed to compare the use of a transurethral laparoscope to the use of a traditional     cystoscope for evaluation of the bladder and ureters at the time of laparoscopic     hysterectomy. The hypothesis was that visual inspection of the bladder and ureters can be     done safely using a transurethral laparoscope, takes less time than traditional cystoscopy,     and is more cost effective than traditional cystoscopy.   "
154481|NCT01261806|"     Toddlers (2- to 3-year-old children) in foster care often have difficulty regulating behavior     and biology, and are at risk for a host of mental health problems. Critical issues for     toddlers straddle the challenges of infancy and preschool years. In particular, toddlers in     foster care face significant challenges in forming new attachment relationships and     developing behavioral and biological regulatory capabilities. This project will assess the     effectiveness of an intervention that targets these issues. Attachment and Biobehavioral     Catch-up for Toddlers in Foster Care (ABC-T) was developed to help parents: provide nurturing     care so that children develop secure, trusting relationships; and supporting children when     they become overwhelmed that enhance children's ability to regulate behavior and biology.     This intervention's effectiveness will be assessed in a randomized clinical trial.   "
154482|NCT01261793|"     The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the     treatment of subjects with Systemic Lupus Erythematosus (SLE).   "
154483|NCT01261780|"     Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer     therapy with few treatment options. CIPN is a complex side effect that varies between     individuals and can be difficult to describe, difficult to treat and can significantly effect     quality of life for patients.      The purpose of this study is to determine if patients with painful CIPN will have a decrease     in pain scores after treatment with the MC-5A device.   "
154484|NCT01261767|"     This trial is conducted in the United States of America (USA). The aim of this clinical trial     is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to     determine the preliminary efficacy in an expansion phase of this trial.      This trial consists of 3 parts: A single dose (SD) dose-escalation phase for 16 weeks, a     multiple dose (MD) dose-escalation phase for 22 weeks, and a MD expansion phase for 22 weeks.      Initiation of the MD expansion phase will depend on results from the SD and MD     dose-escalation phases and only if an acceptable safety profile is present. Subjects     participating in the expansion phase are not allowed to have participated in the previous     phases (SD and MD dose-escalation phases) of the trial.   "
154485|NCT01261754|"     This is a single-blind, randomized, cross-over design. Patients with metastatic prostate     adenocarcinoma; newly diagnosed, high-risk patients with prostate adenocarcinoma; and healthy     subjects will be administered a single intravenous dose of each of the study drugs 99mTc MIP     1404 and 99mTc MIP 1405 administered approximately 14 to 21 days apart.   "
154486|NCT01261741|"     In this study, memantine will be tested in a new indication: in the treatment of subjective     memory, concentration, or attention problems (subjective cognitive impairment) in the absence     of dementia.   "
154489|NCT01261702|"     All patients were premedicated with oral midazolam 5-15 mg. one hour before surgery. General     anesthesia with double lumen endobronchial tube was given. Patient was induced by propofol     and fentanyl. Cisatracurium was given to facilitate intubation. Patient was ventilated with     50% oxygen in air. Anesthesia was maintained with propofol and fentanyl in order to keep     blood pressure and heart rate within 20% of the baseline. Cisatracurium was given every 30     minutes in order to control ventilation. At the end of surgery, neuromuscular blockade was     reversed.In PACU, the I.V. PCA machine was connected to the patient. The setting of PCA was     basal infusion of morphine 1 mg/hr bolus of morphine 1 mg with lockout interval 5 minutes and     4-hour limit 30 mg.The patient's mean arterial blood pressure, heart rate were recorded     before induction, before intubation, at 15, 15, 30, 60, 90 and 120 minutes after intubation,     and at 4, 8,16 and 24 h after surgery. The total amounts of fentanyl, propofol and magnesium     sulphate were recorded. The time between the cessation of magnesium sulphate and extubation     was recorded. The amounts of morphine usage at 4, 8, 16 and 24 hours after surgery were     recorded. Pain score was evaluated at rest and deep breath and sedation score at 1, 2, 3, 4,     8, 16 and 24 hours after surgery using numeric rating scale (NRS). Sedation score was graded     as 0 = fully awake, 1 = somnolence, responds to call, 2 = somnolence, responds to tactile     stimulation, 3 = asleep, responds to painful stimulation. The times that the patient first     sipping, taking food, sitting at the edge of bed and walk with help were also recorded. The     side effects such as nausea, vomiting, pruritus and respiratory depression were recorded.     Cost effective analysis was also evaluated.   "
154490|NCT01261689|"     * The objective of the study: to assess the impact of a proactive policy of offering EA at     the start of labour as compared to a restrictive policy or care as usual.      * Study design: It concerns a multicentre randomised open label trial.      * Study population: Term nulliparous and multiparous women with a child in cephalic     presentation, and without contraindications for vaginal labour or EA.      * Intervention: Women will be allocated to the EA group or the care-as-usual group. In the EA     group, women are given an EA as soon as they are in labour. In the care-as-usual     (restrictive) group, women receive pain relief only on their explicit request.   "
154491|NCT01261676|"     Caesarean (CS) delivery rates in the Netherlands increased from 5 to 15% the last 20 years.     CSs have no clear benefit for overall neonatal outcome and are associated with higher     maternal complications and high costs. Dutch guidelines offer clear recommendations on     factors that have a direct effect on the decision to perform a CS.      Hypothesis: there is incomplete adherence to the recommendations from the guidelines on CS     among Dutch gynaecologists.      This study consists of four phases:        1. Development of quality indicators: A set of quality indicators regarding the process,          structure and outcome of care will be developed according to the RAND-modified Delphi          method. A representative, national expert panel consisting of 12 to 15 obstetricians and          midwives will participate.        2. Current care study: The current Dutch care will be studied in 20 hospitals (N=80          gynaecologists). 1000 files on performed CSs are analyzed regarding the adherence to the          developed quality indicators. To get insight into Dutch practices compared to          international data, basic obstetrical data will be extracted from the delivery database.        3. Barrier analysis: A barrier analysis will be carried out based on the results of the          current care study. Two groups of hospitals will be identified in the upper and lower          extremes of the 'adherence distribution': 5 hospitals with the lowest and 5 hospitals          with the highest adherence scores. Factors that determine the decision to perform a CS          or not (barriers and facilitators) will be analyzed in both groups using semi-structured          interviews among 15-20 professionals and 15-20 patients. A questionnaire will be used to          study the 'prevalence' of these factors among all obstetric gynaecologists in the          Netherlands and among 200 patients.        4. Controlled before- and-after (CBA) study: Based on the outcomes of the current care          study and the barrier analysis, a tailor made implementation strategy will be developed          in order to increase adherence to the CS quality indicators. Target groups will be          selected with focus on women with both a high incidence of the indicator and low          indicator adherence. The strategy will be executed and evaluated in a CBA-study in 12          hospitals (6 intervention, 6 control) in terms of effectiveness, experiences and costs.          The sample size will be dependent on the target group and adherence to the quality          indicators regarding this target group. These data will be available after performing          the current care and the barrier study.   "
154492|NCT01261663|"     Malnutrition is a severe comorbidity in hospitalised patients, especially in elderly. The     consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting     against malnutrition. Their use is easy, and framed by recent French recommendations     suggesting to propose NOS at end of meals or as snacking . Nevertheless, there is no     scientific data to affirm which is the best of these two hypothesis in elderly hospitalised     in Long Term Care Unit(LTCU) . Moreover, a preliminary survey of NOS consumption in LTCU in     Limoges university hospital showed some problems about the mode of supplying NOS, partially     linked with an insufficiency for paramedical staff in realizing importance of NOS. However,     the effect of time of supplying NOS on total food consumption had not been evaluated in this     first study. The new one will include 48 malnourished elderly patients in two LTCU and having     a prescription of NOS. They will receive them at the same quantity during the whole study     either firstly at end of meals (10 days) and secondly as snackings (10 days), or conversely.     Order of choice will be randomised. Total daily alimentary intakes will be noted by     paramedical staff of the two units, and translated by dieticians in daily energy, protein,     carbohydrates and lipids intakes. The time of supplying NOS will be confronted with these     intakes, in order to precise the best one.   "
154493|NCT01261650|"     Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic     widespread pain present at a similar level for at least 3 months. The aim of this study is to     examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce     chronic pain.   "
154494|NCT01261637|"     This study has been designed to determine if women undergoing cesarean delivery with spinal     anesthesia and routine pain management who also have an additional ultrasound guided     transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better     quality of recovery than women who don't have the additional TAP block. Maximizing pain     relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and     acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially     reduce chronic pain.   "
154495|NCT01261624|"     The present study has been designed in order to evaluate the efficacy and safety of two doses     of Givinostat in subjects with polyarticular course JIA      Givinostat ready-to-use suspension especially intended for paediatric administration, will be     administered orally at different daily doses.      Patients with an established diagnosis of one of the following JIA forms (Polyarticular JIA     rheumatoid factor positive or negative, Oligoarticular extended JIA, Systemic JIA without     active systemic features) will be enrolled.      The treatment regimen will remain unchanged for 12 weeks and the clinical response will by     assessed by applying the ACR Pediatric response criteria. Patients achieving at least an ACR     Pediatric 30 response will continue receiving the assigned dose for 12 further weeks.      After the end of study (week 24) responder patients will be allowed to extend the treatment     until they maintain a clinical benefit.   "
160854|NCT00000294|"     The purpose of this study is to examine carvedilol effects in response to cocaine.   "
154503|NCT01261520|"     This study examined whether a culturally-tailored video has a greater impact on increasing     mammography use in Chinese American women and improving barriers to mammography screening     compared to a generic, non-tailored video and a printed fact sheet (control group).   "
154504|NCT01261507|"     A new software product takes two chest radiographs, aligns them, and then subtracts one image     from the other. The resulting image represents an image showing any differences between them.     The study is to determine whether radiologists using this new software perform better with it     than when they do not use it.   "
154505|NCT01261494|"     This study is expected to demonstrate the anti-diabetic efficacy of 3-months treatment with     GFT505 (80 mg/d) on Glycosylated Haemoglobin A1c (HbA1C) and fasting plasma glucose.      And to assess the tolerability and safety of once-a-day administrations of oral doses of     GFT505 for 12 weeks in patients with type 2 diabetes mellitus.   "
154506|NCT01261481|"     The purpose of the study is to compare the relative bioavailability and pharmacokinetics of     tolvaptan 15 mg tablets administered orally versus tolvaptan via nasogastric (NG) tube in     healthy male and female subjects.      This study is an open 2-treatment, 2-period, 2-sequence crossover study to compare the     relative bioavailability of tolvaptan tablets to tolvaptan given via nasogastric tube in 28     healthy adults. Subjects will be randomized to one of the two treatment sequences; either     tolvaptan oral tablets swallowed intact followed by a tablet crushed and administered via     nasogastric tube, or the reverse sequence. Serial pharmacokinetic samples will be collected     following each tolvaptan administration and safety assessments will be performed. The     relative bioavailability of tolvaptan administered via nasogastric tube will be compared to     tolvaptan tablets swallowed intact.   "
154507|NCT01261468|"     The primary purpose is to study the effect of spinal cord stimulation (SCS) on sensory     parameters, using quantitative sensory testing (QST).      Patients with established SCS treatment will be examined with QST. Subjects will be     randomized to have their SCS device turned off or kept active (1:1) for a 12-hour period,     then be reexamined using the same QST protocol.      After the 2nd examination all patients cross over (ie. inactive devices are activated, active     devices are deactivated) and are reexamined after a new 12-hour period.      The investigators expect to demonstrate that SCS treatment has a significant effect on     sensory parameters associated with pain hypersensitivity but no significant effect on sensory     parameters associated with detection of non-painful stimuli.   "
154508|NCT01261455|"     The purpose of this study is to determine if there is any difference in the surgical time     when the surgery is performed with a graft taken from under the upper lid versus lower lid.     The investigators will also be recording the level of pain felt by patients after surgery,     any difficulties during or after surgery, and if the pterygium grows back.   "
154509|NCT01261442|"     The cross sectional area of posterior tibial nerve (PTN) is increased in diabetic patients     with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN.     This study aims to evaluate whether the cross sectional area of the Posterior Tibial Nerve     (PTN) as measured by ultrasound is increased in patients with distal symmetric polyneuropathy     (DSPN) as compared to diabetic patients without DSPN.   "
154510|NCT01261429|"     The purpose of this study is to explore the efficacy of nilotinib as a treatment of patients     with progressive or relapsing pigmented villo-nodular synovitis / tenosynovial giant cell     tumour (PVNS/TGCT) who cannot be treated by surgery.      The primary objective of the study will be to determine the efficacy of 12 weeks (3 months)     of nilotinib treatment as measured by the non progression rate (Complete response + Partial     Response + Stable disease according to Response Evaluation Criteria In Solid Tumours - RECIST     version 1.1) in patients with progressive or relapsing PVNS/TGCT who cannot be treated by     surgery.      this study is an international, multicentre, non-randomized, open-label phase II clinical     trial with a Bayesian design.      A maximum sample size of 50 patients will be included in the study   "
154512|NCT01261403|"     The primary objective of the study is to assess the safety and efficacy of 2 dose groups     (PDA001 versus vehicle control) in subjects with active rheumatoid Arthritis. The secondary     objectives of the study are to determine the clinical response at defined visit intervals,     determine the time to flare of RA symptoms and to quantify changes in inflammatory markers     including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A     (SAA), and IL-6.   "
154513|NCT01261390|"     Moderate to severe sleep apnea (a high number of breathing pauses on a sleep study) is a     common health problem that is often associated with loud snoring and sleepiness.The medical     term for this problem is obstructive sleep apnea (OSA). People with OSA often have an     increased risk for developing heart disease or may already have a diagnosis of heart disease.      A clinical research study is being conducted at Brigham and Women's Hospital (BWH) and Beth     Israel Deaconess Medical Center (BIDMC) to compare the effects of continuous positive airway     pressure (CPAP) to conservative medical therapy with participation in one of four groups:        1. Active-PAP Therapy Group (Active-Beh or Active+Beh): Will receive standard medical          treatment for sleep apnea with active-PAP. Participants will be randomized to either:             1. Active-Pap with respiratory therapist visits only             2. Active-Pap with respiratory therapist visits and cognitive behavioral therapist               visits.        2. Alternative PAP Group (Sham): Will receive lower air delivery level than active-PAP          therapy group. Will also have meetings with respiratory therapist.        3. Conservative Medical Therapy Group (CMT)*: Will receive a free supply of nasal strips          for the duration of their treatment period (either 6 months or 12 months) and follow          healthy sleep hygiene guidelines for how to change sleep habits to minimize incidences          of apneas (breathing disturbances during sleep). Frequent follow-up support with          research coordinator.      A sleep doctor or cardiologist will have indicated that a potential participant is an     appropriate candidate to receive PAP or CMT as acceptable approaches to treat his/her sleep     apnea. Participants will be recruited between the ages of 45-75 years who have diagnosed     heart disease or between 55-75 years for those who have risk factors for developing heart     disease.      This is a 6-12 month study** to evaluate alternative ways to address the potential for OSA     treatment to reduce heart disease and to identify those features that would strengthen a     later, large-scale randomized controlled trial.      We will test the hypothesis that active treatment for OSA with CPAP reduces CVD morbidity and     mortality.      *All randomized participants will be given conservative medical therapy (CMT).      **For those randomized after December 31, 2012, follow-up assessment will only be 6 months     long   "
154514|NCT01261377|"     Patients with both sleep apnea and COPD have overlap syndrome, but their optimal management     is not known. We plan to conduct a randomized trial of of bi-level PAP vs. night time oxygen     to asses the impact of intervention on cardiac MRI and biomarkers.   "
154515|NCT01261364|"     Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive     report improves outcomes when compared with standard treatment without the availability of     genetic information.   "
154516|NCT01261351|"     The primary purpose of the trial is to evaluate coagulation activator markers in patients     with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with     the severity of the pathology.   "
154517|NCT01261338|"     Because of industrial pollution, a large number of people in Annison, Alabama, have elevated     body burdens of the class of compounds known as polychlorinated biphenyls (PCBs). There is     evidence that these compounds are associated with risks to health including diabetes. There     is also evidence that the consumption of a non-absorbable dietary fat can reduce the level of     compounds like PCBs. This clinical trial will test the hypothesis that a non-absorbable     dietary fat can reduce the levels of PCBs in subjects in Anniston.   "
154518|NCT01261325|"     This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and     200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with     partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant     antiepileptic drugs.   "
154519|NCT01261312|"     Phase 1-2 dose escalation randomized study in patients with intermediate or high risk     myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML). The Dose Escalation     Segment will evaluate the biological activity, preliminary safety and efficacy of SGI-110     with two dosing schedules in MDS and AML patients while the Dose Expansion Segment will     further evaluate safety and efficacy at the biological effective dose (BED) or maximum     tolerated dose (MTD)as defined in the Dose Escalation Segment.   "
154520|NCT01261299|"     Carboplatin kills cancer cells mainly through induction of DNA damage (drug-DNA adducts). The     goal of this clinical trial is to determine if chemoresistance to carboplatin can be     identified by measuring carboplatin-induced DNA monoadducts, the precursor of Pt-DNA     diadducts or crosslinks, from subtherapeutic drug doses given prior to the initiation of     chemotherapy. We hypothesize that low levels of carboplatin-DNA monoadducts and rapid     drug-DNA adduct repair correlate with chemoresistance. A highly sensitive technology, called     accelerator mass spectrometry (AMS), will be used to measure carboplatin-DNA monoadducts from     patient samples. AMS can measure C-14 at the attomole level in specimens of milligram size.     In this study, patients will receive one non-toxic microdose (defined as 1/100th the     therapeutic dose) of C-14-labeled carboplatin. Blood specimens will be drawn for     determination of carboplatin-DNA monoadduct formation and repair in peripheral blood     mononuclear cells (PBMC), and pharmacokinetics (PK) will be determined from serum     ultrafiltrate. In patients microdosed prior to providing tumor samples, a few milligrams of     leftover tumor biopsy/resection specimens will be analyzed for formation of carboplatin-DNA     monoadducts. Patients will subsequently receive carboplatin-based chemotherapy. The levels of     microdose-induced carboplatin-DNA monoadducts will be correlated with response to     chemotherapy. Some blood and biopsy samples will be assayed by RT-PCR for several putative     resistance markers at the mRNA level. Side effects will also be monitored and compared to the     AMS data. This trial will also utilize PK, DNA repair and pharmacogenomics data in order to     determine some of the underlying chemoresistance mechanisms.   "
154521|NCT01261286|"     Objective: To determine the effect of C-reactive protein (CRP) status, and infliximab     treatment on the pharmacodynamics and pharmacokinetics of verapamil, a model drug for L-type     calcium channel blocking, in Crohn's disease (CD) patients compared to healthy patients.      Hypotheses:CD patients will have elevated plasma verapamil concentrations, but diminished     dromotropic response to verapamil; the concentration of circulating norepinephrine, used as a     surrogate marker of sympathetic nervous activity, will be similar between the healthy     patients and the CD patients; the sympathetic nervous system of the heart will be similar to     healthy patients; Crohn's disease patients with normal CRP will have higher drug response     compared to high CRP (>3 mg/l) patients; and that infliximab-treated patients will have     higher verapamil response than those with similar symptom profiles who are not infliximab     treated.   "
154544|NCT01260987|"     Nodular Basal Cell Carcinomas:      Compare the efficacy and safety of conventional versus fractional laser assisted PDT for     difficult to treat nodular cell carcinomas in the face.      Actinic keratosis:      Compare the efficacy and safety of conventional versus fractional laser assisted PDT for     moderate to severe actinic keratoses located in the face and on the hands.   "
154522|NCT01261273|"     Title Prospective, single-arm, multi-centre, observational registry to further validate     safety and efficacy of the Nobori® DES in real-world patients.      Objective Primary objective The primary objective of e-NOBORI registry is to further validate     the safety and efficacy of Nobori® DES system in unselected patients representing everyday     clinical practice.      Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac     death, target vessel related myocardial infarction (MI) and clinically driven target lesion     revascularization (TLR) at 1 year   "
154523|NCT01261260|"     On the dual basis of findings indicating GABA increases following acute and eight week     SSRI/dopamine agonist administration and those indicating GABA-ergic effects following 14 day     pyrimidine administration, the purpose of this study is to assess our following hypotheses:        1. Relative to placebo, an oral dose of 1g of uridine BID for seven days will increase          brain GABA levels in a sample of healthy, unmedicated adult males;        2. Relative to placebo, an oral dose of 1g of uridine BID for seven days will increase NTP          levels in a sample of healthy, unmedicated adult males; and        3. Brain GABA levels will be directly correlated to high energy phosphate levels in this          sample of healthy, unmedicated adult males.   "
154524|NCT01261247|"     Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. This phase II trial is studying how well panobinostat works in treating patients     with relapsed or refractory non-Hodgkin lymphoma   "
154525|NCT01261234|"     CAS-CARE study was conducted to evaluate the inhibitory effect of cilostazol, compared to     that of other antiplatelet drugs, on in-stent restenosis following carotid artery stenting     (CAS) in patients scheduled to undergo CAS. Study design is Multicenter Prospective     Ranodomized Controlled Study, rondomized by cilostazol/non-cilostazol group prior to CAS. 900     patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after     CAS, evaluated by carotid ultrasound and angiography.   "
154526|NCT01261221|"     Kaohsiung Medical University Chung-Ho Memorial Hospital will provide a long-term free medical     service in Indian Tibetans since July 2010. The investigators plan to investigate metabolic     syndromes and HIV infection in Indian Tibetan community. The investigators will survey the     prevalence and risk factors by means of HIV quick test and questionnaires. Since there is     lacking of prevalence survey for metabolic syndrome and HIV infection in Tibetan colony of     India, the investigiators will carry out this survey under the support and assistance of     Department of Health of Central Tibetan Government.   "
154527|NCT01261208|"     The purpose of the Study is to investigate the prevalence of Helicobacter Pylori infection     among the HIV/AIDS group. The study will screen the patients who were confirmed HIV/AIDS in     Kaohsiung Medical University Hospital and collect the cases who were suspicious of     Helicobacter Pylori infection.   "
154528|NCT01261195|"     HUVEC primary cells for researches about the relation between plasma leakage and infections.   "
154529|NCT01261182|"     School feeding programs provide students meals conditional on school attendance, which can     have impacts on school participation, cognition and learning, and nutritional outcomes.     Although the literature on impacts of school feeding programs is substantial, high quality     studies with evaluation designs that provide causal impact estimates are relatively few. Thus     program impacts on educational, cognitive and nutritional outcomes are not well-understood,     particularly in a field setting. Nutritional impacts in particular are questionable, which     may be a result program design. Most studies provide only small transfers to children and     examine average macro-nutrient effects of the transfer on the treated children, thus it is     not surprising that detection of nutritional gains has been minimal.      This study is a cluster-randomized evaluation of a school feeding program administered by the     World Food Programme in the Northern Ugandan Districts of Lira and Pader. The program     provides substantially larger food rations than most programs (representing 1/3 of children's     daily caloric needs and 99% of iron intake requirements).      The key research objectives are:        1. Impact on the treated: Assess the effectiveness of the program at improving nutritional          status, education and cognitive and learning outcomes for school-age children, with          particular attention to the anemia status of older school-age girls .        2. Impact on untreated but nutritionally vulnerable sub-groups: Assess the effectiveness of          the program at reducing anemia prevalence in mothers and younger siblings.        3. Optimal program design: Assess the differential impacts of a program in which children          are fed at school compared with one in which they are given dry rations to bring home.   "
154530|NCT01261169|"     This study is designed to explore the use of Myfortic® in patients with steroid-refractory     uveitis. The aim of the study will be to show the therapeutic effect of Myfortic® in managing     uveitis patients.   "
154531|NCT01261156|"     The purpose of this study is to evaluate the effects of diltiazem on the pharmacokinetics     (PK) and pharmacodynamics (PD) of E5555 and its metabolites in healthy subjects.   "
154532|NCT01261143|"     The purpose of this study is to determine the:      Primary end point        -  change of Total symptom score      Secondary end point        -  neurological test   "
154533|NCT01261130|"     This two part study will evaluate the safety and immunogenicity of two formulations of     Na-GST-1, first in hookworm-naïve individuals using an open-label design, and then in adults     living in an area of endemic hookworm infection using a randomized, double-blind design. The     two formulations to be evaluated are Na-GST-1 adsorbed to an adjuvant, Alhydrogel®, and     Na-GST-1 adsorbed to Alhydrogel® and administered with GLA-AF.   "
154534|NCT01261117|"     To determine whether oral or intravenous ibuprofen has a better or same efficacy and     tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm     infants.   "
154543|NCT01261000|"     Acromegaly is a disease of the pituitary gland that involves overproduction of growth     hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout     the body. Human studies have evaluated pegvisomant action by measuring reduction of IGF-I     levels in the blood. However, no studies have evaluated the effects of blocking GH receptors     in tissues. In this study, we will study tissue biomarkers for pegvisomant action in GH and     IGF-I dependent signaling pathways in colon tissue of patients with acromegaly treated with     pegvisomant.   "
154599|NCT01260272|"     This trial compared the effects of raisin intake on cardiovascular risk factors compared to     common, commercially available, alternative snacks. These cardiovascular risk factors include     glucose, blood pressure, lipid levels, body weight, and waist circumference.   "
154535|NCT01261104|"     Purpose: to investigate the relationship between time for treatment seeking and audiometric     data and self-assessment of handicap for patients in a public hearing healthcare service.     Methods: Retrospective study. Records of 152 elderly and 48 adults with hearing impairment     were analyzed. The ISO audiometric thresholds average (500 to 4000Hz) and high frequencies     average (2000 to 6000Hz), the speech recognition thresholds and the total, social and     emotional scores from the Hearing Handicap Inventory for the Adults (HHIA) and Elderly (HHIE)     were compared with the time between the onset of hearing complaints and the first treatment     seeking. Results: The average time for treatment seeking was 7,6 years. No statistical     difference was found between ISO and high frequency audiometric average, HHIA/E scores and     time for treatment seeking between adults and the elderly. Weak but significant negative     correlations were observed between the audiometric data and time for treatment seeking. There     was no relationship between the time for treatment seeking and educational, socioeconomic     levels and perception of handicap. Conclusions: The search for treatment seems to be     multifactorial. Despite technological advances and changes in access to information and     treatment time for treatment seeking was similar to that reported 30 years ago.   "
154536|NCT01261091|"     Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation,     have a particularly bad prognosis. If they require long-term ventilation, their orotracheal     tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal     tube below the larynx. This so called tracheostomy might be associated with advantages such     as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth     hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for     tracheostomy in stroke, however, is not known. This study investigates the potential benefits     of early tracheostomy in ventilated critically ill patients with ischemic or hemorrhagic     stroke.   "
154537|NCT01261078|"     Intrathecal epinephrine has been known to increase the duration of spinal anesthesia, or     increase the quality of anesthesia. However, there is still a controversy, and the mechanism     of epinephrine is recently suggested as a modulator of pain information in the spinal cord.     Therefore, the investigators try to investigate the dose sparing effect of intrathecal     epinephrine for spinal anesthesia with bupivacaine.   "
154538|NCT01261065|"     The overall hypothesis of this application is that the improvement in LV ejection performance     following treatment with betablockers is due, at least in part, to improvement in intrinsic     myocardial contractility.   "
154539|NCT01261052|"     The purpose of this research study is to test an automated blood glucose control system that     includes a new component designed to adapt to stress. The importance of this component is     that when Type 1 Diabetics are stressed (for example, from illness or infection), their body     is resistant to the effects of insulin. The investigators will be adjusting their blood     glucose using insulin and glucagon and making their body less sensitive to insulin with a     steroid, hydrocortisone. Insulin is a hormone that lowers blood glucose. Glucagon raises     blood glucose when it is low. Both are natural hormones made by people without diabetes.     Hydrocortisone is a steroid that will increase their blood glucose temporarily and will be     given every 4 hours. All subjects will participate in two 33 hour experiments. One experiment     will use the adaptive version of the sensor-based glucose control system. The other study     will use the original version of the control system, without the adaptive component, for the     first 13 hours. Then, the adaptive component will be added to the glucose control system for     the remaining 20 hours of the study. Our primary goal is to assess the effectiveness of the     adaptive component to control glucose levels in the presence of steroid-induced insulin     resistance in persons with Type 1 Diabetes Mellitus.   "
154540|NCT01261039|"     Background:      Some patients do not readily absorb vitamin D from intestine. These patients may be helped by     ultraviolet rays, which can come from sunlight or solar beds. When the skin is exposed to     ultraviolet B rays (UVB) vitamin D is produced. This usually happens when the skin is exposed     to sunlight. Vitamin D can also be ingested trough some foods, mainly fatty fish or     supplements.      Vitamin D is important for bone, and long-term vitamin D deficiency can lead to osteoporosis.     Vitamin D may also be important for the immune system—including autoimmune diseases—and the     cardiovascular system.      Purpose:      The main purpose of the study is to learn more about the production of vitamin D3 in the     skin, by ultraviolet radiation.      Study Course:      Day 0: Randomization. Subjects are randomized to two groups. Subjects in both groups will be     exposed to light in a solar bed for approximately 10 minutes on the first day, but only one     of the solar beds wields ultraviolet rays. The other has a filter, which filters out the     ultraviolet rays.      Blood samples are drawn on the first day at following times: Before solar bed, after at 15     minutes, 1, 2, 4 and 6 hours.      Day 1,2,3 and 7 after solar bed exposure:      Blood samples are drawn and adverse events are registered.   "
154541|NCT01261026|"     OBJECTIVE: This study evaluated serum vascular endothelial growth factor (VEGF)     concentrations in women with ectopic pregnancy (EP), abnormal intrauterine pregnancy (aIUP)     and normal intrauterine pregnancy (nIUP).      METHODS: This was a prospective, case-control study comparing serum VEGF concentrations among     72 women with ectopic pregnancy (n=35), abnormal IUP (n=15) and normal IUP (n=22) matched for     gestational age. For the determination of serum VEGF concentration a solid phase sandwich     ELISA was used. Patients were stratified according to serum VEGF above or below 200pg/mL.      RESULTS: The serum level of VEGF was significantly higher in women with ectopic pregnancy     (median 211.1 pg/mL; range 5 - 1017.0 pg/mL) than in women with normal IUP (median 5 pg/mL;     range 5- 310.6 pg/mL) P < 0.0001. Serum VEGF concentrations did not show any statistically     significant difference between women with aIUP (median 231.9 pg/mL range 5 - 813.7 pg /mL )     and EP (median 211.1 pg/mL range 5 - 1017.0 pg/mL). When cut-off concentrations of 200 pg/mL     for VEGF were used, a nIUP could be distinguished from an unviable (EP and aIUP) with a     sensitive of 53%, specificity of 90.9%, a positive predictive value of 92.9% and a negative     predictive value of 46.5%..      CONCLUSIONS: Serum VEGF could not distinguish between an EP and an aIUP. However, serum VEGF     concentrations above 200 pg/mL could discriminate a nIUP from an unviable pregnancy (EP or     aIUP) with a PPV of 92.9%.   "
154542|NCT01261013|"     The purpose of this study is to properly analyse the visual and refractive outcomes of     implantation of KeraRing intrastromal corneal ring segment (ICRS) at the different stages of     keratoconus.   "
154545|NCT01260974|"     The aim of the study is to determine viable use of caspofungin in post-OLTx patients, and to     demonstrate in particular the effectiveness, understood as the ability to reduce the     incidence of invasive fungal infections, and to assess the ability to reduce the risk and     incidence of side effects (toxicity) which may arise in transplant patients treated with     other drugs, especially in individuals recognized as high risk (e.g. renal failure).   "
154546|NCT01260961|"     Dr. Sherie Novotny of the Department of Psychiatry at UMDNJ-RWJMS and collaborators are     starting a treatment trial to determine whether Docosa Hexanoic Acid(DHA), the major omega-3     fatty acid found in the brain and a component of fish oil, has any effects on the symptoms of     autism.      We propose to carry out a trial to test the effect of DHA compared to a placebo (a pill with     no drug in it) on several aspects of autism in children and adolescents, in a 12-week     clinical study with children or adolescents in the age group of 5-17 with a diagnosis of     Autism Spectrum Disorder. Additionally this trial will study genes related to the therapeutic     agent, DHA, and biomarkers related to DHA in the urine.   "
154547|NCT01260948|"     This study investigated the relative bioavailability (rate and extend of absorption) of     Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA     with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc.,     following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult     subjects administered under non-fasting conditions.   "
154548|NCT01260935|"     The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill     anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see     whether one is better than the other.   "
154549|NCT01260922|"     This study investigated the relative bioavailability (rate and extent of absorption) of     Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA     with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc.,     following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult     subjects administered under fasting conditions.   "
154550|NCT01260909|"     In current radiation therapy, imaging (typically, cone beam CT imaging or two orthogonal     X-ray projection imaging) is done for patient setup before radiation dose delivery. Dose     delivery typically takes 2 to 5 minutes depending on the delivery technique used for     treatment. A tumor target may change its position during the dose delivery process. The goal     of this project is develop a real-time imaging strategy to monitor the tumor position during     dose delivery and evaluate its potential clinical impact.   "
154551|NCT01260896|"     The objective of this study was to compare the rate and extent of absorption of venlafaxine     hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference)     administered as 1 x 150 mg extended-release capsule under fasting conditions.   "
154552|NCT01260883|"     Infants handle ketorolac differently than adults. Study of handling of this pain medication     given to infants following surgery. Detailed analysis of how the drug is eliminated from age     2 months to 18 months. Compared morphine use in infants who received the drug to the group     getting placebo. Safety testing for kidney and liver function, breathing measured by     continuous oximetry, and any bleeding issues.   "
154553|NCT01260870|"     To evaluate the procedural safety and to identify and characterize therapeutic and functional     endpoint assessments in subjects with documented critical limb ischemia who received     treatment with the Cotavance Paclitaxel-Coated Balloon vs. those who received POBA only.   "
154554|NCT01260857|"     Aldazide 25 mg OD will be given to Filipino hypertensive patients, and there will be 2     follow-up visits on week 4 and week 8 to monitor for safety and efficacy as primary and     secondary outcomes, respectively.   "
154555|NCT01260844|"     Phase 1, drug-drug interaction study to evaluate the effects of Briakinumab on hte     pharmacokinetics of single doses of CYP substrate in subjects with moderate to severe     psoriasis.   "
154556|NCT01260831|"     The purpose of this study is to evaluate the impact of Bedside Paediatric Early Warning     System (Bedside-PEWS) on early identification of children at risk for near and actual     cardiopulmonary arrest, hospital mortality, processes of care and PICU resource utilization.   "
154557|NCT01260818|"     Tranexamic acid has been shown to reduce postoperative blood losses and transfusion     requirements in a number of types of surgery. Most trials in orthopedic surgery have been     conducted intravenously in arthroplasty, hip fracture and spine surgeries. This study would     aim to see the effect of topical use of tranexamic acid in reduction of blood loss and     transfusions for total hip arthroplasty   "
154558|NCT01260805|"     A Phase I, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine the     Bioequivalence of Ethinylestradiol + Gestodene - The objective of the study is to verify     through a single dose study, if the two formulations of Ethinylestradiol 0,02mg + Gestodene     0,075mg sugar coated tablets are bioequivalent when administered at the same dose and under     fasting conditions.   "
154559|NCT01260792|"     Almost all rating scales for Attention-Deficit/Hyperactivity Disorder (ADHD) are not     validated in France. This clearly hampers the development of the diagnosis and the monitoring     of patients but also research in this domain. This study is conceived to collect data in the     general population of children aged from 4 to 18 years in public schools in the city of Nice.      Children are pseudo-randomly selected from classes of randomly selected schools in the city     of Nice (France). Teachers fill out questionnaires using a dedicated secured website, and ask     parents to fill out a similar set of questionnaires regarding their child's behaviour at     home. Since ADHD has a strong genetic components, parents are also asked to fill out     questionnaires regarding their own behaviour at adulthood and in childhood retrospectively.      Additionally, known factors related to ADHD and other disorders as well as other putative     factors are tested in the epidemiologic study.   "
154560|NCT01260779|"     This compassionate use protocol provides expanded access for investigational use of PV-10 in     cancer patients who are not eligible for an existing PV-10 clinical trial, for whom there is     no comparable or satisfactory approved alternative therapy and whom, in the opinion of the     investigator, may benefit from PV-10 administration.   "
154561|NCT01260766|"     The purpose of this study was to demonstrate the effect of short treatment with active OPLON     patches on Acne.   "
154562|NCT01260753|"     The purpose of this study is to explore the activity of UR-63325 in a model of allergic     rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise     healthy.   "
154563|NCT01260740|"     Background:      - Two areas on the surface of the brain, the dorsolateral prefrontal cortex (DLPFC) and motor     cortex (MC), play a key role during learning. Researchers are interested in determining the     effect that transcranial magnetic stimulation (TMS) on the DLPFC and MC has on participants'     performance of learning tasks. By studying the effect of TMS on reaction time, learning, and     memory, researchers hope to better understand how to treat conditions such as Parkinson's     disease and traumatic brain injury that affect these parts of the brain.      Objectives:        -  To study the effects of transcranial magnetic stimulation on the dorsolateral prefrontal          cortex and motor cortex.        -  To learn which areas of the brain are used to perform certain learning and memory tasks.      Eligibility:      - Healthy, right-handed individuals between 18 and 70 years of age.      Design:        -  Participants will be screened with a physical and neurological examination and a medical          and psychiatric history.        -  Participants will be asked to take part in one of five different parts of this study.          Most participants will have four 2-hour visits to the National Institutes of Health          Clinical Center. Some participants (those involved in Part 5) will have only one 2-hour          visit.        -  Parts 1 and 2 (four visits): Participants will have TMS, and then do a learning task          that may provide a small monetary reward. On the first visit, before the TMS,          participants will take an intelligence test based on reading aloud the words given on a          card. Participants who have not had a routine magnetic resonance imaging (MRI) scan of          the brain within the past year will also have a scan.        -  Parts 3 and 4 (four visits): Participants will have a functional MRI scan while doing a          learning task that may provide a small monetary reward. On the first visit, before the          functional MRI, participants will take an intelligence test based on reading aloud the          words given on a card. Participants who have not had a routine magnetic resonance          imaging (MRI) scan of the brain within the past year will also have a scan.        -  Part 5 (one visit): Participants will take an intelligence test based on reading aloud          the words given on a card. Then, participants will have TMS followed by a functional MRI          scan. During the functional MRI, participants will do a button-pressing task that may          provide a small monetary reward.        -  Participants will also be asked to provide a small blood sample for genetic analysis.   "
154564|NCT01260727|"     The purpose of this study is to evaluate the safety of and immune response to an HIV vaccine,     administered using two different devices, followed by a vaccine boost, in healthy,     HIV-uninfected adults.   "
154565|NCT01260714|"     This phase I trial studies the best dose of azacitidine and to see how well it works with     mitoxantrone hydrochloride and etoposide in treating older patients with acute myeloid     leukemia that has a lower chance of responding to treatment or higher risk of returning (poor     prognosis). Drugs used in chemotherapy, such as azacitidine, mitoxantrone hydrochloride, and     etoposide, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more cancer cells.   "
154566|NCT01260701|"     This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients     with advanced gastric or gastroesophageal junction cancer. Akt inhibitor MK2206 may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
154577|NCT01260558|"     The objective of this pilot study is to compare the PFS-eluting stent (ISAR Rapa G1) with the     PPS-eluting stent (Cypher®) regarding uncovered stent strut segments at 5 years.   "
154578|NCT01260545|"     The purpose of this study is to examine the safety and tolerability of CA-18C3 in subjects     with hematologic malignancies, as well as look at the preliminary efficacy of IL-1alpha     blockade.   "
154567|NCT01260688|"     This randomized phase II trial is studying the side effects and how well giving cediranib     maleate together with or without dasatinib works in treating patients with hormone-resistant     prostate cancer resistant to treatment with docetaxel. Cediranib maleate and dasatinib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by     blocking blood flow to the tumor. It is not yet known whether giving cediranib maleate     together with dasatinib or alone is an effective treatment for prostate cancer.   "
154568|NCT01260675|"     Phase 1 study to determine the pharmacokinetic profile of NanoBUP Capsules to Suboxone.   "
154569|NCT01260662|"     This will be a randomized trial of propofol versus the combination of propofol and ketamine     for procedural sedation for procedures in the Emergency Department (ED). Propofol produces     sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County     Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is     also frequently used in the ED in children and sometimes in adults. It has been proposed that     by combining the two agents, the negative side effects of respiratory depression and     hypotension associated with propofol, and the negative effects of dysphoria and vomiting     associated with ketamine, can be avoided.      In the proposed study, patients seen in the ED who will require procedural sedation for a     painful procedure will be randomized to receive either propofol or propofol and ketamine.     During the procedure, patients will be monitored per the standard of care, including use of a     cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample     end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully     completed and the patient has returned to his/her baseline mental status, the patient will be     asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure,     memory of the procedure, and overall satisfaction with the procedure.   "
154570|NCT01260649|"     Electroconvulsive therapy (ECT), is considered the most effective treatment for severe     treatment resistant major depressive disorder (MDD), but it requires about 3 weeks of     treatments and can cause considerable acute deficits in memory. It would be a major advance     in treatment if ECT could work faster with fewer treatments and result in decrease incidence     of memory problems. Ketamine is an excellent candidate for augmentation of ECT because of its     acute effects on depression, its short half-life, and its safety profile when given at low     doses. Ketamine is given as an infusion and could easily be incorporated into the routine     management of patients undergoing ECT, but has never been evaluated prospectively in this     context.      The investigators propose to assess the efficacy, feasibility, tolerability and safety of     N-methyl-D-aspartate antagonist augmentation of ECT using ketamine.   "
154571|NCT01260636|"     To compare two gadolinium contrast agents in terms of global paired diagnostic preference     (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid,     renal/abdominal and peripheral arteries   "
154572|NCT01260623|"     The objective of the investigators pilot study is to assess the pharmacokinetic profile of     two corticosteroid drugs, prednisone and prednisolone, in children who present to the     pediatric emergency department with an asthma exacerbation. The investigators hypothesis is     that the pharmacokinetic profile in this population will be similar to healthy children and     adults.   "
154573|NCT01260610|"     Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although     it may not be sustained for long. Also it remains unknown if combination of more potent     analogues is more beneficial than individual drugs. Thus this study is carried out to     determine the efficacy and safety of combination of tenofovir plus telbivudine (two most     potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week     open labelled, prospective, randomized, multicentric study. The patient will receive either     tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the     non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will     continue receiving tenofovir plus telbivudine for 104 weeks.   "
154784|NCT01258348|"     The purpose of this study is to determine a safe dose of LY573636-sodium to be given in     combination with sunitinib to patients with metastatic Renal Cell Carcinoma (RCC) and to     determine any side effects that may be associated with LY573636-sodium and sunitinib     combination in this patient population. The tumor response rate will also be assessed.   "
154574|NCT01260597|"     The purpose of this proposed study is to develop, refine and test the use of Interactive     Voice Response (IVR) technology as a means of increasing re-engagement of low income smokers     in telephone support for tobacco cessation (quit lines). If this strategy proves to be     acceptable and feasible, it may offer a technological solution to increase access to and     utilization of a widely available evidence-based form of behavioral treatment for low income     smokers.      The primary aims of this research are to:        1. Develop an IVR system that delivers tailored audio messages to increase low income          smokers' re-engagement in treatment offered by two state quit lines (Washington and          Indiana). The investigators will develop: a) a menu of audio messages that can be          delivered by an IVR system; b) an IVR algorithm (i.e., a set of decision rules) to make          proactive automated calls to deliver brief, tailored messages for re-engaging low income          smokers who previously used the quit line.        2. Evaluate the feasibility and efficacy of an IVR system as a tool to re-engage low income          smokers into quit line treatment measured by number of IVR calls answered, number of          smokers who re-engage in treatment and satisfaction with IVR calls. Hypothesis 2.1 - It          is hypothesized that the rates of re-engagement into treatment among those receiving the          IVR intervention will be higher than smokers not proactively invited to re-engage in          quit line services.   "
154575|NCT01260584|"     This study is being conducted to determine if smoking will influence the platelet aggregation     inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any     effect on the plasma concentrations of the active metabolite of prasugrel and the active and     inactive metabolites of clopidogrel.      The primary hypothesis is that smoking status will influence the antiplatelet effects and     active metabolite concentrations of clopidogrel but will have no impact on prasugrel's     antiplatelet effects or active metabolite concentrations.   "
154576|NCT01260571|"     Sixty two subjects will take part in this study. The study is unic arm. The subjects used the     product once and will be evaluated in the regression of pimples in the times 0,4,6,8 and 24     hours after application.      A follow-up visit will be made 24 hours after initiation of treatment.   "
154579|NCT01260532|"     Autoimmune thyroid disease is the most common organ-specific autoimmune disease. AITD include     Graves' disease and Hashimoto's thyroiditis. Although the pathogenesis of AITD remains     unclear, it is generally thought that the mechanisms of the disease is a complex disease in     which susceptibility genes and environmental triggers act in concert to initiate the     autoimmune response to the thyroid.      The initial step of thyroid autoimmunity is the activation of T cells. The activation of T     cell requires two signals: firstly, thyroid follicular cells or antigen presenting cells     binds to T cell receptor through antigenic HLA complex. Secondly, the activation of T cells     is also required the interaction of costimulatory molecules between thyroid follicular cells     and immune cells, including CTLA-4, CD 40, CD28, ICOS. PPAR- is a kind of intranuclear     transcription factor, associated with adipogenesis and inflammation. Some reports showed that     PPAR- polymorphism may have a protective effect from Graves' ophthalmopathy.      The goal of the study is to investigate the relationship among SNP and mRNA of costimulatory     molecules and PPAR- , serum cytokine including TNF- and sIL-2R, and clinical characteristics     in AITD patients. From the study, we hope to clarify the role of costimulatory molecules and     PPAR- polymorphism in AITD.   "
154580|NCT01260519|"     The project tests the incidence of femoral arterial sheath thrombus formation during     diagnostic coronary angiography and effect of intravenous (iv) heparin bolus administration     in reducing this risk in comparison to placebo.   "
154581|NCT01260506|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in     patients with Relapsed Glioblastoma Multiforme.   "
154582|NCT01260493|"     The present study Continuum of care for frail elderly people form part of the research     programme Support for frail elderly persons - from prevention to palliation     (www.vardalinstitutet.net) which comprises research into three interventions. The program     comprises interventions addressing frail elderly people in different phases of the     disablement process, from elderly people who are beginning to develop frailty to very frail     elderly people receiving palliative care.      The intervention Continuum of care for frail elderly people addresses elderly people who     are frail and that have a great risk of high health care consumption. The hypothesis is that     an intervention program for frail elderly people can reduce the number of visits to the     emergency department, increase the life satisfaction and maintain the functional ability. The     intervention, including an early geriatric assessment at the emergency department, early     family support, a case manager in the community with a multi-professional team and active     follow-up by the case manager, contributes to early recognition of the elderly people's need     of information, care and rehabilitation and of informal caregivers' need of information. It     enhances the transfer of information and integrates the care between different caregivers and     different care levels, thereby better recognize frail elderly people's needs. Specifically,     this study is expected to show that the intervention has a positive effect on the frail     elderly person's functional ability, life satisfaction, satisfaction with health and social     care, and health care consumption.   "
154583|NCT01260480|"     The purpose of this study is to determine whether [18F]-ML-10 used in conjunction with PET     imaging is effective as an imaging tool for the early detection of response of oncological     tumors in the lungs,head and neck to chemoradiation therapy.      The study will evaluate the potential of [18F]-ML-10 used in conjunction with PET imaging to     distinguish early during the course of chemoradiation therapy between a tumor that responds     to the therapy, and a tumor that does not respond to the therapy. Currently, this distinction     is available to the physician several weeks or months after completion of therapy, using     anatomical imaging (for example Computed Tomography [CT] or Magnetic Resonance Imaging     [MRI]).   "
154785|NCT01258335|"     Aim: To demonstrate the short-term multi focal electroretinogram (mfERG) effect of oral     omega-3-fatty acids in the triglyceride form on dry age-related macular degeneration (AMD).      Null hypothesis: Omega-3-fatty acids do not affect the mfERGs of patients with dry AMD.   "
154584|NCT01260467|"     The purpose of this study is to determine if a medication called memantine is effective in     treating glioblastoma. Memantine targets a specific receptor, called a glutamate receptor,     which is thought to be involved in the growth of brain tumors. It has previously been studied     for other types of conditions, such as Alzheimer's disease, but it has not yet been evaluated     in the treatment of brain tumors. The investigators will also be determining how common it is     for patients with brain tumors to have side effects to memantine. Memantine will be taken by     mouth twice a day.   "
154585|NCT01260454|"     Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial     hypertension, a life threatening disease of the lung blood vessels. Unfortunately,     treprostinil is irritating to the skin and many patients experience intense pain at the     infusion site for the first 7-10 days after placing a new subcutaneous infusion site.      Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of     post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that     pretreatment of an area of skin with Qutenza would decrease the pain associated with a new     treprostinil infusion site. The investigators hope that Qutenza will decrease both the     intensity of the pain and the duration of the pain after patients place a new treprostinil     infusion site.      In this initial study, the investigators will provide Qutenza in open-label, unblinded     fashion and ask patients to rate their pain using a diary tool with which they are already     comfortable.   "
154586|NCT01260441|"     Each year in the United States, 300,000 people suffer from a Cardiac Arrest (CA), and of     them, there is a 90% mortality rate. Out-of-Hospital arrests, in particular, have a 1-5%     survival to hospital discharge. High quality CPR is crucial to lowering the mortality rate     and increasing survival, yet only 15-30% of out-of-hospital CA victims receive bystander CPR.     Studies have shown that prompt administration of CPR dramatically improves outcomes. In a     recent study from Switzerland, lay bystander CPR doubled the survival rate at one month. Our     study will look to train family members of at-risk cardiac patients in the skills of CPR     through the American Heart Association's (AHA) CPR Anytime Friends and Family Personal     Learning Program (CPR Anytime) to see if these family members are able to learn and perform     quality CPR in the event that their family member should suffer a cardiac arrest.   "
154587|NCT01260428|"     Altitude tolerance correlates with the level of oxygenation achieved. The aim of the present     study is to investigate whether increased expiratory pressure within the thorax is able to     improve oxygenation during hypoxic hypoxia.   "
154588|NCT01260415|"     This is a phase II study to assess whether treatment with chemotherapy drugs FOLFOX     (5-Fluorouracil (5FU), Oxaliplatin (Eloxatin) and Leucovorin (Folinic Acid)) or FOLFIRI     (5-Fluorouracil (5FU), Irinotecan (Camptosar) and Leucovorin (Folinic Acid))and panitumumab     before and after surgery can improve outcome in patients with liver metastases (the cancer     has spread to other parts of the body such as the liver) that are resectable (can be     surgically removed), from colorectal cancer that have a non mutant (wild-type) K-ras gene.      FOLFOX/FOLFIRI is an intravenous (given by vein) chemotherapy combination that is approved     for colorectal cancer while panitumumab is also an intravenous drug and have been approved     for treatment of refractory (not responding treatment) metastatic colorectal cancer whose     cancers have the K-ras gene. These drugs are not approved for the treatment of colorectal     cancer liver metastases (CRCLM) who can have surgery.      Patients will receive FOLFOX/FOLFIRI and panitumumab for four 2-week cycles before surgery.     Surgery will be done no sooner than 4 weeks and no later than 8 weeks, after completion of     the fourth cycle of chemotherapy.      If the liver metastases after the chemotherapy and surgery decreases or stops growing, then     chemotherapy will be given after surgery. Treatments will start no sooner than 4 weeks, and     no later than 12 weeks, after surgery. Patients will receive a maximum of 8 cycles of     treatment with the combination of drugs and then receive panitumumab alone for a maximum of     12 cycles.      On treatment visits, patients will also have tests and procedures done. As part of the study,     patients will provide archival tumor tissue and sample of tissue removed from surgery for     K-ras testing. Patients will also be given the option of allowing the collected tissue for     research (biomarker) studies and banking for future studies.   "
154589|NCT01260402|"     Biventricular pacing is a validated treatment for patients suffering from heart failure     resistant to medical treatment. However, up to 30% of the patients are non responsive to this     strategy using the coronary sinus approach to pace the Left Ventricle (LV).      It has been demonstrated that the magnitude of the improvement was highly dependant on the LV     pacing site. The coronary sinus approach rarely offers more than 1 or 2 potential pacing     sites. Resynchronisation using a transeptal approach to pace the left ventricle on the     cardiology has been shown feasible on small series. We therefore would like to compare these     two approached in a randomised prospective study to confirm the hypotheses that endocardial     LV pacing by offering multiple choices for the pacing sites reduces the number of non     responders and is associated with greater hemodynamic benefit when compared to the     conventional coronary sinus approach.   "
154590|NCT01260389|"     This study would like to test the hypothesis that a pharmaceutical care intervention would     result in an improved drug adherence and inhalation technique in Chronic Obstructive     Pulmonary Disease (COPD) patients over a 3 month-period.   "
154591|NCT01260376|"     This study will investigate free fatty acid and VLDL-TG metabolism before and during exercise     with and without pharmacological antilipolysis by the niacin antagonist Acipimox. Main     focuses will be VLDL-TG and free fatty acid metabolism as well as expression of membrane     proteins in fat- and muscle biopsies.   "
154592|NCT01260363|"     Pain treatment after anterior cruciate ligament reconstruction - Comparison of infiltration     analgesia with femoral nerve block after.   "
154593|NCT01260350|"     This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and     without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in     subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.   "
154594|NCT01260337|"     The purpose of this research study to find out whether a pre-packaged, portion controlled     diet with a group behavior modification program or group diabetes support and education, is a     safe and effective way for people with type 2 diabetes to lose weight and manage their     diabetes.   "
154595|NCT01260324|"     The objectives of this study were to: (1) evaluate the natural history of non-arteritic     anterior ischemic optic neuropathy (NAION); (2) estimate the population incidence of NAION;     and (3) identify potential risk factors for NAION.   "
154596|NCT01260311|"     This is an observational study and will determine the safety profile of fesoterodine in     Filipino patients prescribed the drug. This is in compliance with the requirements of the     Philippine Food and Drug Administration.   "
154597|NCT01260298|"     The objective of this study is to observe body contour changes following treatment using the     MC1 device.   "
154598|NCT01260285|"     The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery     patients.   "
168627|NCT00035685|"     To examine whether or not primary school-aged children with asthma from low-income households     have lower household environmental tobacco smoke (ETS) exposure than matched control     children.   "
154600|NCT01260259|"     Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved     outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to     elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory     and cell survival pathways, and thus protect remote organs against future ischemic injury. We     hypothesize that compared to sham treatment, RIPC will be associated with decreased     post-operative acute kidney, myocardial, and lung injury.   "
154601|NCT01260246|"     This is a randomized, double-blind, placebo-controlled trial evaluating the impact of     sitagliptin therapy in patients with concomitant type 2 diabetes and non-alcoholic     steatohepatitis (NASH) on improving liver disease based on biopsy results. The effect of     sitagliptin on other measures such as hormones modifying insulin release and sensitivity     (termed adipocytokines), fat distribution, and biomarkers of cardiovascular risk will also be     evaluated.   "
154602|NCT01260233|"     The purpose of this study is to determine whether a perioperative smoking cessation program,     implemented at least 3 weeks prior to elective surgery, is effective in increasing rates of     smoking cessation or reduction. Intraoperative and immediate postoperative complications will     also be compared.   "
154603|NCT01260220|"     An isolation-limited segmental antral approach to pulmonary vein isolation is as effective in     achieving long-term freedom from atrial fibrillation as the standard anatomic,     circumferential antral ablation.   "
154604|NCT01260207|"     The purpose of this study is to determine whether interactive voice response (IVR) technology     can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best     practice guidelines (BPGs).      The study hypothesis is that ACS patients who are contacted by IVR technology will be more     likely to receive care as recommended in the BPGs than those followed by usual care.   "
154605|NCT01260194|"     This open-label, multi-center study will evaluate the efficacy and safety of Herceptin     (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients     with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction.     Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin     as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until     disease progression.   "
158943|NCT01203241|"     The aim of the present study is to assess whether left atrial roof ablation adds any benefit     in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.   "
154606|NCT01260181|"     This single arm, open-label study will evaluate the efficacy and safety of erlotinib     (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer     (NSCLC) with epidermal growth factor receptor (EGFR) mutations.   "
154607|NCT01260168|"     The objective of this study is to confirm the sensitivity of a stool DNA test for detection     of colorectal cancer and pre-cancer.      Another objective is to provide anonymous, clinically characterized specimens for a     bio-repository for future colorectal cancer-related test development.   "
154608|NCT01260155|"     This study will be a single-center, open-label, randomized, 3-treatment crossover     bioavailability study of single oral doses of E5501 old tablet formulation under fasted     conditions and a new tablet formulation administered under fed and fasted conditions in     healthy subjects.   "
154609|NCT01260142|"     This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of     fospropofol disodium in comparison to propofol. In addition, the study will compare the     maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.   "
154610|NCT01260129|"     Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical     study is designed to demonstrate that the newly adopted dose is not inferior to the existing     dose in its efficacy and safety.   "
154611|NCT01260116|"     This study is going to determine the efficacy, tolerability and safety of ziprasidone in 120     schizophrenic patients with depressive symptoms. The study will be carried out at 2 mental     centers in China. Subjects will be required to attend the center at screening, baseline,     Weeks 1, 2, 4 ,6 and 8 or early termination visit.      At screening, patients underwent psychiatric and physical examination, standard lab tests,     and an Electrocardiograph.      At baseline, if they continued to be eligible, they began ziprasidone 20 mg twice daily.      Depending on response and tolerability, ziprasidone could be gradually escalated to a maximum     of 80 mg twice daily.   "
154612|NCT01260103|"     Primary Objectives      To compare progression free survival (PFS), the time from randomization to progressive     disease,in children with optic pathway glioma (OPG) age ≥ 6 months to < 18 years, who receive     combination antineoplaston therapy (ANP therapy) vs. temozolomide (TMZ); study subjects will     have 1) received prior treatment with carboplatin or cisplatin, which was terminated     secondary to toxicity or progression of OPG, or 2) developed recurrence of OPG after     completion of carboplatin or cisplatin therapy. PFS data will be censored on the date of the     last tumor assessment documenting absence of progression for study subjects:        -  Who are alive, on study and are progression-free at the time of the analysis;        -  Who discontinue, receive no subsequent therapy and are progression-free at the time of          the analysis;        -  Who are given/change therapy other than the study treatment prior to observing          progression;        -  Who discontinued (due to personal preference or toxicity) with a change in therapy,          withdrew, or was lost to follow-up;        -  For whom documentation of disease progression or death occurs after ≥ 2 consecutive          missed tumor assessments.             -  To describe the toxicity profile for ANP therapy vs. TMZ.      Secondary Objectives:        -  To compare overall survival (OS) for subjects treated with ANP therapy vs. TMZ;        -  To compare disease stabilization rates for subjects treated with ANP therapy vs. TMZ;        -  To compare complete response (CR), partial response (PR), stable disease (SD), and          progressive disease (PD) rates for subjects treated with ANP therapy vs. TMZ.   "
154676|NCT01259258|"     We prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who     received 2 ml intratunical space injection of methylene blue before spermatic vein ligation     with 40 controls in whom no mapping technique was adopted in the period between January 2008     and Feb. 2010, in Mansoura university hospital ward 7.After surgery, the patients were     assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy,     pain or other complications with mean follow up was 15+ 7months.   "
154677|NCT01259245|"     The purpose of this study was to compare the self-efficacy and quality of life parameters of     Chronic Obstructive Pulmonary Disease(COPD)patients who underwent pulmonary rehabilitation     with and without Tai Chi elements incorporated in the exercise component in a General     Out-patient setting.   "
154613|NCT01260090|"     Traumatic brain injury has a high morbidity and mortality in both civilian and military     populations. Blast and other mechanisms of traumatic brain injury damage the brain by causing     neurons to disconnect and atrophy. Such traumatic axonal injury can lead to persistently     vegetative and minimally conscious states, for which extremely limited treatment options     exist, including physical, occupational, speech and cognitive therapies.      More than 50,000 patients have received vagus nerve stimulation for epilepsy and depression.     In addition to decreased seizure frequency and severity, patients report enhanced mood,     reduced daytime sleepiness independent of seizure control, increased slow wave sleep, and     improved cognition, memory, and quality of life.      The purpose of this study is to demonstrate objective improvement in clinical outcome by     placement of a vagus nerve stimulator in patients who are recovering from severe traumatic     brain injury. Our hypothesis is that stimulation of the vagus nerve results in increased     cerebral blood flow and metabolism in the forebrain, thalamus and reticular formation, which     promotes arousal and improved consciousness, thereby improving outcome after traumatic brain     injury resulting in minimally conscious or persistent vegetative states. If this study     demonstrates that vagus nerve stimulation can safely and positively impact outcome, then a     larger randomized prospective crossover trial will be proposed.      The investigators will achieve this objective by evaluating whether vagus nerve stimulation     impacts clinical recovery from minimally conscious or persistent vegetative states caused by     traumatic brain injury as assessed by the FIM™ instrument and Functional Assessment Measure     (FIM+FAM) as well as the JFK Coma Recovery Scale Score. The investigators will also evaluate     whether vagus nerve stimulation alters resting and activational functional MRI.      Twelve patients will be enrolled in this initial crossover pilot study. These patients will     have sustained a severe traumatic brain injury (Disability Rating Scale score of 22 to 29)     more than twelve months from starting the study, and have no other concurrent active severe     medical problems. Baseline EEG and magnetic resonance imaging (MRI) will be performed prior     to left vagus nerve stimulation implantation. Patients will be randomized to alternating     three month periods with the device on or off. Outcomes will be assessed at three month     intervals with the FIM™ instrument and Functional Assessment Measure (FIM+FAM) and JFK Coma     Recovery Scale by a neuropsychologist blinded to the status of the device. Outcomes will also     be assessed using quantitative eye movement tracking and functional magnetic resonance     imaging. Patients will cross over every 3 months and be followed for at least 18 months.   "
154625|NCT01259934|"     The aim of this study is to evaluate the effect of giving adjuvant treatment with     intermediate doses of interferon-alpha2b to patients operated for high risk melanoma.     Patients are randomly assigned to either observation only or interferon treatment for 2     different durations. The outcome with respect to overall survival, relapse-free survival,     side effects and quality of life is analysed.   "
154637|NCT01259778|"     This is a National, Multicentre, Observational Registry to study Adherence and Long Term     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth     hormone treatment from hospital in Korea in order to assess the level of adherence of     subjects receiving SAIZEN® via easypod™.   "
160855|NCT00000295|"     The purpose of this study is to investigate progesterone effects in female smokers   "
154614|NCT01260077|"     Objective: At present, vestibular evoked myogenic potentials are analyzed only in the time     domain. A technique to evaluate this potential in the frequency domain could provide more     information, but has only been applied within the last year. Design and Study Sample: In this     study we recorded vestibular evoked myogenic potential in the time domain, in 156 ears of 78     normal-hearing young adults, at frequencies of 250, 500, 1000 and 2000 Hz, with intensity of     90 dB nHL. Next, the steady state vestibular evoked myogenic potential was recorded at the     same carrying frequencies, modulated at 20, 37, 40, 43, 70, 77 and 80 Hz. Results: The     responses found by modulated frequency, regardless of carrier, recorded a higher presence of     peaks and mean amplitudes between 20 and 70 Hz, especially at 40 Hz. Conclusions: The results     show that the observation technique in the frequency domain is feasible and shows a strong     association with the time domain for recording vestibular evoked myogenic potentials, at     carrying frequencies of 250, 500, 1000 or 2000 Hz.   "
154615|NCT01260064|"     1. Laparoscopic appendectomy may not be a superior procedure when compared with open     appendectomy; 2. Various modifications in laparoscopic appendectomy procedure may reduce the     technical diffuculty and overall costs.   "
154616|NCT01260051|"     Currently, no clear consensus exists regarding the effect of epidural anesthesia upon     breast-feeding. In theory, epidurals may increase breast-feeding failure via inadequate     maternal milk production, deficiencies in neonatal neurobehavior, or both, but most studies     have failed to separate these potential mechanisms. The present study examines whether     epidural duration correlates with 1) likelihood of breast-feeding at hospital discharge and     2) neonatal neurobehavioral deficits in feeding, as measured by the L&A components of the     standardized, validated LATCH scoring system.   "
154617|NCT01260038|"     This is an observational study to evaluate the feasibility of the implementation of a     personalized treatment strategy based on specific tumor marker (f.i. EGFR-mutation) in the     routine clinical care setting in the Antwerp region (Belgium).   "
154618|NCT01260025|"     1. MTD and DLT of M2ES        2. Pharmacokinetics of M2ES   "
154619|NCT01260012|"     Liver fibrosis is the most serious complication of schistosomiasis mansoni. However only     limited proportion of subjects with infection develop this pathology and there is limited     knowledge on risk factors for the differential morbidity patterns observed in endemic     communities. Our preliminary cross-sectional study indicated that serum levels of     antioxidants may be related with the development of fibrosis. The present project is a     randomised double blinded placebo controlled prospective study investigating the role of food     based antioxidant supplements on the outcome of anti-schistosomal chemotherapy with regards     to the extent of fibrosis reversal.   "
154620|NCT01259999|"     Dietary intake in frail elderly is often lower than estimated needs due to the combined     effects of the anorexia of ageing, frailty and the presence of acute and chronic disease. The     objectives of the present study are to assess the effects of an oleic acid rich formula     fortified with micronutrients on energy intake, vitamin- and mineral status, muscle strength     and mobility. The investigators have recently performed a similar study in an acute ward     setting without micronutrients.   "
154621|NCT01259986|"     The purpose of this study is the evaluate the efficacy of using a low-energy 635 nm visible     light laser in the treatment of various recalcitrant forms of vitiligo.   "
154622|NCT01259973|"     The purpose of this study is to determine in healthy volunteers treated with typical or     atypical antipsychotics -AP-, the relationship between genetic polymorphisms in cytochrome     genes CYP2D6 (*3, *4, *5, *6 and Nxn) and CYP3A5 (*3) with antipsychotic pharmacokinetics,     occupancy of striatal dopaminergic receptors and the appearance of extrapyramidal     symptomatology -EPS-.   "
154623|NCT01259960|"     Being confronted more and more with obese as well as older patients, minimally invasive     surgery is said to keep the surgical trauma low. The prospective long-term evaluation is the     continuous monitoring of patients undergoing lumbar minimally invasive fusion surgery and     analyzing the effect of body mass index (BMI) and wound healing.   "
154678|NCT01259232|"     To investigate the brain abnormalities and the association with gene in schizophrenia     patients and their relatives.   "
154679|NCT01259219|"     Open label pharmacokinetic RBT dose-finding study in young (≤ 5 year old) HIV-infected     children receiving a LPV/RTV-based ART regimen and who have a recent history of completing TB     treatment.   "
154680|NCT01259206|"     Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate     from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by     decreased ability of tissue repair and increased reactive ossification. Thus, the     investigators aimed to determine CS incidence in asymptomatic obese subjects with and without     type 2 diabetes mellitus (T2DM).   "
155312|NCT01250964|"     The purpose of this study is to determine if there is any difference in astigmatism (eye     surface curvature) or corneal endothelial cell density (the inner cell lining of the eye     surface) after two different methods for inserting a lens during cataract surgery.   "
154624|NCT01259947|"     Abstract Background: There is no universally accepted and effective prophylaxis of migraine     headache episodes. Thus the investigators aimed to investigate the effects of Lippia alba     (Mill.) N. E. Brown, an herb with many effects on central nervous system, on pain frequency     and intensity of migraine patients.      Methods: Patients were enrolled in a prospective, phase 2, non-controlled cohort study to     orally receive ethanolic extract of L. alba leaves (1-2 drips/kg/day). Headache intensity and     frequency of episodes were recorded before and after 30-60 days of treatment. The     investigators also studied the chemical composition of its essential oil by gas     chromatography-mass spectrometry.      Results: The investigators described for the first time a particular L. alba chemotype with     geranial and carvenone as major compounds. With treatment, both frequency and intensity of     pain episodes significantly decreased from baseline to first reassessment date. More than 80%     of patients experienced a minimum 50% reduction on pain intensity and frequency. No side     effects were reported.      Conclusions: Treatment with a geranial plus carvenone chemotype of L. alba ethanolic extract     is a cheap, widely available, highly effective therapy to reduce both the intensity and the     frequency of headache episodes of migraine patients with no side effects.      Keywords: headache, migraine, medicinal plant, essential oil, phytotherapy   "
154712|NCT01259050|"     The purpose of this study is to determine the safety of Zinc given at 90mg/d in conjunction     with 2mg/d of copper in ALS patients.   "
154626|NCT01259921|"     The purpose of this study is to determine whether neurofeedback (NF) training can     significantly reduce the symptoms of Posttraumatic Stress Disorder (PTSD) in individuals with     significant affect dysregulation and chronic, treatment-resistant PTSD. The primary aims of     this study include:        1. To examine whether NF has the potential to significantly reduce symptoms of PTSD.        2. To examine whether NF training can specifically target the area of affect regulation.        3. To examine the mechanism of NF through elucidating the relationship between affect          regulation and PTSD symptom change.   "
154627|NCT01259908|"     Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally     laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be     followed up and the results will be compared between the two procedures on the basis of the     primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity,     graft thrombosis and all-cause mortality.   "
154628|NCT01259895|"     The purpose of this study is to determine the effect of different time of sleep restriction     on control of food intake and metabolism of obese and normal subjects.   "
154629|NCT01259882|"     This is a two part study. The purpose of the first part is primarily to determine the safety     and toleration and pharmacokinetics of PF-05089771 following single escalating doses.     Secondary objectives will be to investigate the PK of an alternative formulation of     PF-05089771 and the effect of food on the PK of PF-05089771. The second part of the study     will focus on investigation of the exploratory pharmacodynamics of PF-05089771 using novel     biomarkers in healthy volunteers. The doses selected in Part B will have been administered     previously in Part A of the study.   "
154630|NCT01259869|"     The purpose of this study is to find out whether the new drug PX-866 will slow the growth of     your glioblastoma multiforme.   "
154631|NCT01259856|"     This research is looking at two conditions, Essential Thrombocythemia (ET) and Polycythemia     Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes     too many platelets and red blood cells to be made. Platelets are particles which circulate in     the blood stream and normally prevent bleeding and bruising. Having too many platelets in the     blood increases the risk of developing blood clots, which can result in life threatening     events like heart attacks and strokes. When the number of red blood cells is increased in PV     this will slow the speed of blood flow in the body and increases the risk of developing blood     clots.      The purpose of this study is to look at the effectiveness of giving participants who have     been diagnosed with ET or PV one of two different study regimens over time. The study subject     will be followed for their condition for about 5 years. The subject will be randomized into     one of two study regimens, either Pegylated Interferon Alfa-2a (PEGASYS) or Aspirin and     Hydroxyurea (also called Hydroxycarbamide). The subject must be newly diagnosed or already     receiving treatment for either PV or ET. Each of the study drugs used in this study is     already being used to treat subjects with ET or PV currently, but the investigators are     unsure which study drug is better.   "
154632|NCT01259843|"     The study examined the clinical characteristics and conditions of care for patients with     acute aortic syndrome (AAS) that will identify patients at risk for increased morbidity and     mortality and provide a basis for the eventual achievement of specific studies on the optimal     therapeutic management according to different risk profiles. The aim of the Observatory is to     provide a photograph size of practices in France at present, both in the larger centers     than in smaller and optimize diagnostic and therapeutic currently available by the activation     pathways of rational management.   "
154633|NCT01259830|"     Post-operative pain after laparoscopic colon and rectal surgery in fast-track design.      A fast-track program is an evidence-based, multimodal approach for patients undergoing     surgery to reduce perioperative morbidity, hospital stay and cost and to increase patient     centered well-being. Optimized pain relief is a core component of any fast-track regimen.      In this context epidural analgesia has become the standard of care for early postoperative     pain therapy.      However, it is debated whether non-opioid analgesics should be given as adjuncts when     epidural analgesia is already present.      The purpose of this study is to demonstrate that the administration of etoricoxib 120mg     additionally to the clinical routine therapy (epidural catheter) reduces the post-operative     pain level during movement after laparoscopic colon surgery in the fast-track design.   "
154681|NCT01259193|"     Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with     antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.      Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer.     Emerging data suggest that zoledronic acid may also exhibit anticancer properties.      The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic     Acid and to evaluate overall survival and time to progression.   "
168628|NCT00035698|"     To identify genes involved in obesity.   "
154634|NCT01259817|"     The aim of this research is to look at two conditions, Essential Thrombocythemia (ET) and     Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and     PV causes too many platelets and red blood cells to be made. Platelets are particles which     circulate in the blood stream and normally prevent bleeding and bruising. Having too many     platelets in the blood increases the risk of developing blood clots, which can result in life     threatening events like heart attacks and strokes. When the number of red blood cells is     increased in PV this will slow the speed of blood flow in the body and increases the risk of     developing blood clots.      It is important for patients with ET or PV who are at risk of blood clots to receive drugs     which will minimize the risks of developing these blood clots but at the moment the     investigators are not sure which drugs will best control the disorder.      The purpose of this study is to look at the effectiveness of giving patients who have been     diagnosed with ET and PV a study drug regimen using Aspirin and PEGASYS (also known as     Pegylated interferon alfa-2a, instead of the standard treatment drug called Hydroxyurea (or     hydroxycarbamide or Hydroxyurea), for whom this drug may not be suitable. The drug may not be     suitable either because it is not adequately controlling the number of blood cells or some     specific side effects occur.   "
154635|NCT01259804|"     Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy   "
154636|NCT01259791|"     This study consists of a series of prospective, randomized placebo-controlled n of 1 trials     to objectively evaluate the reproducibility of subjective and objective symptoms among     patients with a history of statin-related myopathy.   "
154638|NCT01259765|"     The investigators hypothesize that :      oral administration of VHH batch 203027 will be        -  safe and tolerable for healthy Bangladeshi humans of all age groups (Part I)        -  effective in reducing severity of diarrhoea in children with proven rotavirus infection          (Part II). This entry only covers Part II.   "
154639|NCT01259752|"     This is a multicenter prospective randomized superiority controlled trial comparing leg     stockings and standard care to standard care of ankle sprain and testing the hypothesis that     compression stockings enable to reduce the median of recovery from ankle sprain by at least 6     days.   "
154640|NCT01259739|"     The purpose of this study is to characterize the potential improvement of cocoa flavanols on     exercise capacity in highly trained cyclist. A placebo-controlled double-blinded randomized     control study will be performed in 13 highly trained cyclist (crossover design). Participants     will perform a baseline exercise testing on an ergometer. They will receive either a     flavanol-poor or flavanol rich cocoa drink twice daily for one week before a second and third     exercise testing is performed. The order of drinks is randomized and balanced     (high-flavanol-->low-flavanol drink or low-flavanol drink-->high-flavanol drink)   "
154641|NCT01259726|"     The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621     dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the     frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to     evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a     dose regimen of VP 20621 to be used in future studies.   "
154642|NCT01259713|"     The study aims to investigate whether prophylaxis with liposomal amphotericin B (AmBisome®)     can reduce the incidence of invasive fungal infections (IFIs) in patients with Acute     Lymphoblastic Leukemia (ALL) who are undergoing their first remission induction.   "
154643|NCT01259700|"     Cardiovascular disease is the leading cause of death in China. At the village level,     strategies for the control of cardiovascular disease are mostly absent. National clinical     guidelines for the management of hypertension and cardiovascular disease are rarely     disseminated to, or implemented by, the village primary care providers. Salt reduction has     greater potential in rural China than almost anywhere else in the world. Very high levels of     salt consumption, very little use of processed food and most dietary salt deriving from home     cooking makes the removal of salt from the diet easier, cheaper and more worthwhile than in     almost any other setting. The two large-scale cluster-randomized controlled trials proposed     here will precisely and reliably define the effect of two highly plausible intervention     strategies on important clinical outcomes. The evidence provided by the project will form the     basis for policy setting that has the potential to greatly reduce the occurrence of vascular     disease in rural China and take an important step towards balancing the rural urban divide in     health and healthcare.   "
154644|NCT01259687|"     Pulse transit time (PuTT) - the time between R wave on ECG and initiation of upstroke in the     peripheral arterial waveform - described in the previous studies as value that reflects     changes in both blood pressure and blood volume. The investigators are assuming that PuTT     changes reflect the dynamic of systolic blood pressure but not cardiac output fluctuations.   "
154645|NCT01259674|"     The present clinical trial will examine the use of ABO/MEG-B-09 syrup in children with acute     cough as compared to a placebo syrup.   "
154660|NCT01259479|"     Background:        -  Cisplatin and carboplatin are standard cancer treatment drugs used for various childhood          cancers, including brain tumors. Both drugs frequently have severe side effects that may          reduce their effectiveness, particularly in children, and new treatments are needed that          may be similarly effective but less toxic for cancer patients.        -  Satraplatin is an experimental drug, similar to cisplatin and carboplatin, that has not          yet been approved by the Food and Drug Administration. Satraplatin has been shown to          treat cancer by interfering with genetic material (DNA) in cancer cells. Some adults          with cancer who have received satraplatin had slowing of the growth or shrinkage of          their tumor. Researchers are interested in determining whether satraplatin can be          effective for cancers that occur in children.      Objectives:        -  To evaluate the safety and effectiveness of satraplatin as a treatment for children and          young adults who have solid tumors that have not responded to standard treatment.        -  To study the effects of satraplatin on the body in terms of side effects and blood          chemistry.        -  To examine the effect that genetic variations may have on the effectiveness of          satraplatin.      Eligibility:      - Children, adolescents, and young adults between 3 and 21 years of age who have solid tumors     (including brain tumors) that have not responded to standard treatment.      Design:        -  Participants will be screened with a full physical examination and medical history,          blood tests, and tumor imaging studies.        -  Participants will receive satraplatin pills to be taken every day in the morning for 5          consecutive days, with no food for 2 hours before or 1 hour after the dose. Participants          will then have 23 days without the drug to complete a 28-day cycle of treatment.          Participants will also receive medication to prevent nausea and vomiting 30 minutes          before the first dose of satraplatin. Following the first dose of satraplatin,          medication for nausea will be given if needed.        -  Satraplatin doses will be adjusted based on response to treatment, including potential          side effects. Participants will have frequent blood tests and imaging studies to          evaluate the effectiveness of the treatment and monitor any side effects, as well as          hearing tests and other examinations as required by the study researchers.        -  Participants will receive satraplatin every 4 weeks for up to 2 years until serious side          effects occur or the tumor stops responding to treatment.   "
154646|NCT01259661|"     Hormonal changes associated with menopause, chronological aging, and lifestyle, especially     physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women.     Women exhibiting the metabolic syndrome have multiple coronary artery disease risk factors,     including insulin resistance, hyperlipidemia, and hypertension. This study will be conducted     to test the hypotheses: (1) physical activity and physical fitness levels may have effects on     individual risk factors of the metabolic syndrome in postmenopausal women; (2) endurance     exercise training may have a favorable effect on components of the metabolic risk variables     in these women.      In this study, the associations among physical activity (including daily energy expenditure     and energy expenditure from moderate to vigorous activity), cardiopulmonary fitness level,     and metabolic risk profile of the women will be assessed. The investigators will perform a     randomized trial to compare the effects of moderate-intensity aerobic exercise training     regimens on metabolic risk factors. Postmenopausal women who exhibit at least one risk factor     for metabolic syndrome will be randomized in the exercise group or control groups. Metabolic     risk factors (e.g., body mass index, waist-to-hip ratio, glucose, insulin, blood pressure,     lipid profile and adiponectin level) will be measured at baseline, and 12 weeks of the study.     Differences from baseline to follow-up will be calculated and compared across groups.      Results of this study may help health care providers providing advice to postmenopausal women     for life style changes to reduce risk of insulin resistance, coronary heart disease, and     diabetes.   "
154647|NCT01259648|"     The primary objective is to determine whether, during a rapid sequence intubation by     etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2     different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous     reactional tachycardia.   "
160856|NCT00000296|"     The purpose of this study is to determine the effects of cotinine with or without a     transdermal nicotine replacement on tobacco withdrawal symptoms.   "
154648|NCT01259635|"     The freezing burden will be quantified in subjects with Parkinson's Disease (PD)before and     after 6 weeks of training. Two types of interventions (20 subjects in each group) will be     tested: 1) Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG     training includes walking courses aimed at provoking freezing episodes. The experimenter will     trigger an auditory rhythmic stimulation (RAS) in walking conditions likely to invoke     freezing (e.g., turning) and the subject will learn to synchronize his/her gait with the     auditory cues, i.e., to keep the walking pace and coordination and, as a result, to avoid     freezing. Similar principles will apply for the CLG training; however, the RAS will be     elicited automatically by a device that recognizes an approaching freezing episode.   "
154649|NCT01259622|"     The purpose of this study is to evaluate the effects of a single intravenous infusion of K201     compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of     subject's symptom score, and safety.   "
154650|NCT01259609|"     The purpose of this study is to determine whether ciliary body thickness increased in the     presence of diabetic macular edema and whether it changed after pars plana vitrectomy.   "
154651|NCT01259596|"     The purpose of this study is to determine if cognitive-behavioral therapy (CBT)and supportive     therapy delivered by telephone are effective for reducing worry and anxiety in rural older     adults with Generalized Anxiety Disorder (GAD).   "
154652|NCT01259583|"     Due to the increasing demand for colonoscopy in clinical practice, great interest has     recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm     Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as     compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance     of the above techniques versus AI in unsedated patients.   "
154653|NCT01259570|"     The encapsulation within CM may improve bioavailability (BA) of vitamin D (VD), even in     absence of fat.      As a model the investigators have chosen nonfat yoghurt. The investigators will prepare     yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ;     (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into     skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched     skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr     yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by     CMIA. In vitro simulated digestion will be studied.      Expected results: The BA of VD in CM would not be lower than in fat   "
154654|NCT01259557|"     The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the     treatment of Essential blepharospasm.   "
154655|NCT01259544|"     13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine     function in patients with Chronic Pancreatitis.   "
154656|NCT01259531|"     This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week     treatment of patients with severe urinary disorders associated with benign prostatic     hyperplasia (BPH).   "
154657|NCT01259518|"     This is an open-label, parallel-group, two-center, safety, activity and pharmacokinetic study     of TriN 2755 given at increasing dose levels as intravenous infusions administered over 4     hours. The study is divided into two parts: Part I a dose escalation phase and Part II an     extension phase.   "
154658|NCT01259505|"     The purpose of this study is to evaluate the safety of HLA-A*2402 restricted epitope peptides     CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 emulsified with Montanide ISA 51.   "
154659|NCT01259492|"     This study will evaluate efficacy and safety of methylphenidate hydrochloride extended     release compared to placebo in adult patients with childhood-onset attention     deficit/hyperactivity disorder (ADHD).   "
154674|NCT01259297|"     This study was planned to provide new information regarding the role of aliskiren (with or     without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly     individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing     major cardiovascular (CV) events and on global measures of physical, executive and cognitive     function.   "
154675|NCT01259284|"     The goal of this clinical research study is to learn if Lipitor (atorvastatin) or fish oil     supplements can help to control side effects of the heart that are commonly seen after lung     surgery (such as irregular heartbeat). Researchers also want to learn if one of these drugs     is more effective than the other at controlling side effects.   "
154682|NCT01259180|"     The purpose of ths study is to determine the efficacy of acupuncture on chronic pelvic pain     in women with endometriosis or adenomyosis.   "
154661|NCT01259466|"     This project will be a randomized clinical trial testing the efficacy of an     internet-administered smoking cessation treatment for overweight and obese smokers. Research     on internet-administered behavioral treatments for smoking cessation has found that compared     to control treatments (e.g., self-help materials), cessation rates in internet-administered     treatments are significantly higher. Research testing the applicability of these treatments     to overweight and obese individuals has not yet been conducted. Given that a substantial     portion of smokers are also overweight and at elevated cardiovascular risk, there is a need     for directed treatment efforts for this group. The current trial proposes to be the first to     test the effectiveness of internet-administered smoking cessation treatment for overweight     and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of     internet-administered treatment consisting of either: a) standard smoking cessation treatment     with general health education, or b) standard smoking cessation treatment with cognitive     behavioral therapy (CBT) for weight concerns. Participants in both conditions will receive     open-label treatment with the 21 mg transdermal nicotine patch.   "
154662|NCT01259453|"     The investigators seek to provide immunization for individuals who are at high risk of     contracting hepatitis B virus (HBV) infection because of their illicit drug use. The     investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport,     CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The     primary purpose of the study is to compare the standard schedule of hepatitis B vaccination     at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The     investigators hypothesize that the accelerated scheduling will result in improved completion     rates without significant loss in vaccine efficacy.   "
154663|NCT01259440|"     Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk     factors of male gender, being overweight, and increasing age. OSA is caused by upper airway     obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway     pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is     suboptimal. Because research shows that adherence patterns are established early in     treatment, we seek to use a technology that enables early and frequent productive     interactions between patient and provider.   "
154664|NCT01259427|"     The purpose of this study is to determine if Ending Self-Stigma (ESS), a 9-session group     intervention designed to assist veterans with serious mental illness to develop skills (SMI)     to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and     stereotypes, is more effective in reducing internalized stigma and its associated effects     than an active comparison group.   "
154665|NCT01259414|"     TACE is considered the standard treatment for unresectable HCC and is widely used as a     palliative treatment. However there is no consensus of the protocol of TACE.One of the     variation is does the stability of the suspension by emulsified the lipiodol and the contrast     medium used to dissolve the anticancer agents really effect the survival.Thus the     investigators conduct this prospective,randomized controlled study to find out if the     different method of preparing chemotheraputic drugs can cause a different survival benefit.   "
154666|NCT01259401|"     The Veterans Millennium Health Care and Benefits Act (Millennium Act) of 1999 mandated the     Department of Veterans Affairs (VA) to provide non-institutional long-term care to veterans.     Adult Day Health Care (ADHC) is a key component of that spectrum of long-term care services.     Veterans in ADHC commonly suffer from limited poor functioning, depression, cognitive     problems and low quality of life. These factors can lead to continued deterioration in     functioning, loss of independence, hospitalizations, nursing home placement and death. Sleep     disruption is associated with depression, low quality of life, functional decline, nursing     home placement, and death among older people. Sleep disturbance is common among ADHC     patients, it is not addressed within routine clinical care, and treatment may be limited to     medications. Studies show that untreated insomnia and medications for insomnia can increase     risk of falls and other health events among older persons. On the other hand, non-medication     treatments for sleep do not show these problems. These treatments have been shown to be     effective in other studies. The goal of this study is to test non-medication treatments to     improve sleep among older Veterans with insomnia in a VA ADHC program. The study design will     facilitate translation into routine care and application in other similar VA programs.   "
154667|NCT01259388|"     The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated,     and effective at treating progressive forms of multiple sclerosis.   "
154668|NCT01259375|"     Primary Objectives        1. To evaluate the Response Rate (RR) for amrubicin in patients with metastatic or advanced          sarcoma as first line therapy.        2. To evaluate Progression Free Survival (PFS).      Secondary Objectives        1. To assess the safety and tolerability of amrubicin in this patient population.        2. To evaluate whether certain histologic subtypes of sarcoma demonstrate a differential          response to amrubicin.        3. To investigate quality of response with radiographic evaluation using both Response          Evaluation Criteria In Solid Tumors (RECIST) and Choi criteria.        4. To evaluate overall survival (OS).   "
154669|NCT01259362|"     Cocaine addiction is a serious disease. Nowadays we still have no efficient method reducing     craving and extending the abstinence period of this patients during treatment.      The aim of this study is to evaluate reduction if craving and other parameters related to     addiction within this group of patients through a treatment with transcranial magnetic     stimulation.   "
154670|NCT01259349|"     Coaxial microincision cataract surgery using 1% ultrasound is not inferior to standard     coaxial microincision cataract surgery in patients of grade 0.1-6.0 immature senile cataract     in terms of corneal endothelial safety.   "
154671|NCT01259336|"     The purpose of this study is to determine whether there itraconazole is effective in the     treatment of chronic cavitary pulmonary aspergillosis   "
154672|NCT01259323|"     The purpose of this study is to assess the Safety and Tolerability of REGN668 (how the body     reacts to the drug) compared to placebo (an inert substance) in patients with     moderate-to-severe extrinsic Atopic Dermatitis.   "
154673|NCT01259310|"     This is a three-center prospective case-control study to examine the patterns of fertility     among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy     (WWoE).   "
155313|NCT01250951|"     This study will evaluate the efficacy and safety of deferasirox in patients with MDS,     thalassemia and rare anemia patients with transfusion iron overload.   "
154684|NCT01256996|"     In the last decade, the number of dental implantations continuously increases. However, at     the same time, the prevalence of peri-implantitis increases, too. Although both surgical and     non-surgical interventions are available for the therapy, there is no efficient and     satisfying therapy option resulting in an adequate improvement of this disease.      An innovative, low abrasive powder has been introduced for the therapy of periodontitis.     However, the powder might be suitable for the peri-implantitis therapy, also, and could     improve the effectiveness of the therapy. The usage of this powder in peri-implantitis     patients has not been assessed in a clinical trial although the effectiveness in natural     teeth has been demonstrated.      The aim of this prospective, randomised, multi-centre trial is to assess the effectiveness of     the aforementioned powder in peri-implantitis patients.   "
154713|NCT01259037|"     This study will look at high frequency ultrasound as a medical imaging modality and apply it     to skin lesions. Elastography is an ultrasonic method of looking at the hardness of an area.     We will use this to try and differentiate between benign and cancerous skin lesions.   "
154714|NCT01259024|"     This study involves the combined use of the FDA approved device, LC Bead and the FDA approved     drug, Doxorubicin for the treatment of primary hepatocellular carcinoma (HCC). The current     indication of the LC Bead is for the embolization of hypervascular tumors and arteriovenous     malformations. The study is designed to establish if drug eluting beads are more effective     and less toxic than standard chemoembolization treatment.   "
155078|NCT01254019|"     The purpose of this study is to determine whether GSK2402968 is effective in the treatment of     ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be     corrected by exon 51 skipping.   "
154685|NCT01256983|"     Sleep-wake dysregulation is a disturbance in the roughly 24-hour cycle of the circadian     rhythm. Well known disorders presenting a sleep-wake dysregulation are seasonal affective     disorder, jet lag and shift work. These people experience a serious mood change when the     seasons change. When the day-night rhythm is desynchronized, they have sleep disturbances,     little energy, and often feel depressed. An established intervention to treat this disorder     is bright light therapy. Light therapy is used for affective disorders for shift workers, jet     lag symptomatology and for advancing or delaying desynchronized rhythms.Two proxy measures     for sleep-wake dysregulation are sleep quality and daytime sleepiness. It is known from cross     sectional studies that renal transplant (RTx) recipients have a prevalence between 30% to 62%     of poor sleep quality measured by self report; a prevalence of impaired daytime functioning     of 34% 12 and a prevalence of depressive symptomatology of 20% to 22%. Sleep-wake     dysregulation in other chronically ill population are a risk factor for morbidity and     mortality.      RTx nurses in the follow-up care are in the frontline for recipient's symptoms respectively     problems. The psychosocial variables that should be addressed, having an association with     morbidity and mortality are sleep, daytime functioning, adherence to immunosuppressive     medication, exercise, smoking and depressive symptomatology.      In the following research project we will address the following gaps: the fact that nature of     sleep disturbances in RTx recipients has never been assessed, that there is no prevalence     available on sleep-wake dysregulation and that there is no data on bright light therapy     intervention in RTx recipients.      Hypothesis: Renal transplant recipients having a sleep wake disregulation will have an     improved sleep quality and less daytime sleepiness after 21 days of light therapy.   "
154686|NCT01256970|"     Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive     age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic     criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous     as the syndrome. This first part of study is determine whether genetic polymorphisms     influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and     controls. Furthermore, women with PCOS were reported with high risk of cardiovascular     disease, the investigators planned to calculate the difference of carotid intima-media     thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal     control to determine the premature atherosclerosis of women with PCOS.   "
154687|NCT01256957|"     The purpose of this study is to evaluate the ability of portable high efficiency particle air     (HEPA) filters to reduce exposures to PM2.5 and woodsmoke air pollution indoors and to     improve subclinical indicators of microvascular function, systemic inflammation, and     oxidative stress among healthy adult participants.   "
154688|NCT01256944|"     Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive     age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic     criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous     as the syndrome. Of those diagnosed with PCOS using the 2003 Rotterdam criteria, 61%     fulfilled 1990 NIH criteria for unexplained hyperandrogenic chronic anovulation. The patient     populations with the new phenotypes had less severe ovulatory dysfunction and less androgen     excess than patients diagnosed using the 1990 NIH criteria. These findings might be common     across all female populations with PCOS, whether in Oriental or Occidental countries. Data     for clinical hyperandrogenism indicated that the prevalence of hirsutism in Taiwanese PCOS     women is lower than that for Caucasians/Western women.      The extent of metabolic abnormalities in women with PCOS may vary with phenotype, age and     ethnicity. Obesity represents a major risk factor for metabolic syndrome and insulin     resistance. Approximately 40-50% of all women with PCOS are overweight or obese. Obese     subjects with PCOS had a higher risk of developing oligomenorrhea, amenorrhea and biochemical     hyperandrogenemia than non-obese women with PCOS. Moreover, obese women with PCOS had     significantly more severe insulin resistance, lower serum LH levels, and lower LH-to-FSH     ratios than non-obese women with PCOS. PCOS women in Taiwan presented with higher LH-to-FSH     ratio and lower insulin resistance than PCOS women in Western Countries. However, the average     body mass index (BMI) was significantly lower in Taiwanese PCOS women than Western women,     which might partially explain the difference between these two populations in terms of     clinical and biochemical presentations.      To further document the ethnic variation between women with PCOS in Taiwan and Western, the     effect of obesity on the diagnosis and clinical presentations of PCOS-related syndromes     should not be neglected in future studies. Therefore, the investigators plan to do this     prospective study for evaluation the clinical and biochemical presentation of Taiwanese women     with PCOS.   "
154689|NCT01256931|"     Organ transplant patients who participated in a retrospective study and received 2009     Pandemrix vaccine during autumn 2009 are included in this study.      The main aim is to determine the H1N1 antibody levels one year after Pandemrix in comparison     to healthy controls. The secondary aim is to examine the booster effect of 2010 Fluarix in     patients and controls.Side effects to Fluarix vaccine are registered.   "
154690|NCT01256918|"     There is a correlation between phacodepth required for full thickness nuclear crack and the     various grades of cataract   "
154691|NCT01256905|"     The purpose of this study is to evaluate if a drug commonly used to treat excessive day-time     sleepiness, called armodafinil (Nuvigil), is also effective in improving the impairment in     the attention commonly reported by patients with more advanced Parkinson's disease (PD) and     Lewy body disease (LBD).   "
154692|NCT01256840|"     The purpose of this study is to see whether people who have restricted the number of calories     they eat for a long period of time, compared to normal-eating and obese people, have markers     of cellular aging that look younger.   "
154693|NCT01256827|"     The purpose is to assess long term vision outcomes and disease status in patients with     age-related macular degeneration previously treated with ranibizumab as participants in the     Phase 3 ANCHOR and MARINA Studies and the HORIZON Study.   "
154694|NCT01256814|"     The purpose of this study is to assess a new behavioral intervention to help how people     living with HIV/AIDS practice self-management skills. Specifically, we want to see if a new     educational intervention can improve physical activity, sleep, mental wellness and quality of     life in HIV(Human Immunodeficiency Virus)-infected men and women. We hypothesize that those     who are in the intervention group will practice more self-management skills than those in the     control group.   "
154695|NCT01256801|"     The investigators want to develop a gene expression profile for the prediction of     immunotherapy response of patients with metastatic breast cancer presenting malignant pleural     effusion.   "
154742|NCT01258660|"     The purpose of this study is to examine and compare the uptake of levomefolate calcium     (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of     treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking     contraception. Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) was     co-administered over the entire period of 44 weeks.   "
154696|NCT01256788|"     This study will look at patients with post-operative treatment of a meniscal tear or     degenerative joint disease (degenerative arthritis). They will be randomized into one of     three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are     randomized into the injection group will receive a series of three injections (one a week for     3 weeks), then a booster injection at 6 months post-op. Several questionnaires will be     given after the first set of injections, then again at a one year follow-up.      The hypothesis is that patients receiving hyaluronic acid injections will have better pain     and function scores as compared with placebo and no further treatment at all time points.   "
154770|NCT01256554|"     The goal of this clinical study is to learn the feasibility of using a single session of     radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural     spinal cord compression.   "
154697|NCT01256775|"     Peripheral arterial disease (PAD) is almost invariably associated with a generalized     atherosclerotic involvement of the arterial tree and endothelial dysfunction. Previous short     term studies showed improvement of vascular reactivity and walking capacity in PAD patients     by measures aimed at restoring Nitric Oxide (NO) production. NO is also known to prevent the     progression of atherosclerosis. We wished to assess whether the prolonged administration of a     NO-donating agent (NCX 4016) improves the functional capacity of PAD patients and affects the     progression of atherosclerosis as assessed by carotid intima-media thickness (IMT).      Four hundred forty two patients with stable intermittent claudication were enrolled in a     prospective, double blind, placebo-controlled study and randomized to either NCX 4016 800mg     bid or its placebo for 6 months. The primary study outcome was the absolute claudication     distance (ACD) on a constant treadmill test (10% incline, 3km/hr); main secondary end-point     was the change of the mean far-wall right common carotid artery IMT.   "
154698|NCT01256762|"     The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat     + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab)     alone for patients with locally recurrent or metastatic breast cancer who have not received     chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.   "
154699|NCT01256749|"     The fundamental reason for comparing the ability of the Frontal Sedline TM     Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for     burst suppression detection is to determine if a less expensive, less invasive and possibly     more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced     intraoperative burst suppression therapy (IBST) for cerebral protection.   "
154700|NCT01256736|"     The purpose of this study is to evaluate 1 year extension study of the efficacy and the     safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with     moderate to severe active RA and an inadequate response to current DMARD.   "
154701|NCT01256723|"     The main purpose of this study is to observe the incidence of major adverse cardiac and     cerebrovascular events (MACCE), target vessel failure (TVF), target vessel revascularization     (TVR) and stent thrombosis out to 5 years after the procedure in patients who underwent     percutaneous coronary intervention (PCI) with everolimus-eluting stents for unprotected left     main coronary artery (ULMCA) disease and lesions involving the ULMCA in Japan. The     investigators will also establish a method of adjustment to the Japanese version of the     SYNTAX score by conducting an assessment using the SYNTAX score recently reported in the US     and Europe as well as the EuroSCORE, and by clarifying the differences of PCI procedures and     treatment results in Japan with those reported in the US and Europe.   "
154702|NCT01256710|"     The purpose of the SJM International, Inc. sponsored Trifecta™ Durability Study, is to     evaluate the long-term durability of the Trifecta™ valve.   "
154703|NCT01256697|"     Retinitis pigmentosa is a genetically determined disease consisting of progressive     centripetal retinal degeneration starting in the rods outer segments. Its prevalence is     1:4000 people and is the fourth most common blinding disease in Israel in 2004 [7% of all     blindness]. The investigators tried to treat a non-progressive form of the disease [Fundus     Albipunctatus] by oral therapy of the food supplement made from alga Dunaliella bardawil     composed of approximately 50% 9-cis β-carotene. The alga Dunaliella bardawil accumulates high     concentration of β -carotene when grown under appropriate conditions. The β -carotene of the     alga is composed of approximately 50% of all-trans - β carotene and 50% 9-cis β -carotene.      The 9-cis β -carotene has shown to be a precursor of 9-cis retinoic acid both in-vitro in     human intestinal mucosa and in-vivo in a ferret, perfuse with 9-cis b-carotene. The night     vision, as measured objectively by electroretinography (ERG) more than doubled in six     patients tested. The visual field was also improved significantly.   "
154704|NCT01259154|"     Introduction: The aim of the study was to investigate the effectiveness of combined bipolar     radiofrequency surgery of the tongue base (RFBT) and uvulopalatopharyngoplasty (UPPP) in a     single session for obstructive sleep apnea (OSA) and to determine whether this combination is     safe and well tolerated.   "
154705|NCT01259141|"     Mycoplasma pneumoniae, an important pathogen of community acquired pneumonia,are becoming     more and more resistant to macrolide. The study aim is to optimize anti-infection therapy.   "
154706|NCT01259128|"     The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years     or older nocturic patients.   "
154707|NCT01259115|"     The purpose of this study is to assess the pharmacokinetics of buprenorphine and its     metabolites in the presence and absence of ketoconazole.   "
154708|NCT01259102|"     The purpose of this study is to determine the pharmacokinetics of BTDS following same-site     patch reapplication after rest intervals.   "
154709|NCT01259089|"     Hsp90 inhibitor AUY922 and erlotinib hydrochloride may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the     side effects and best dose of Hsp90 inhibitor AUY922 when given together with erlotinib     hydrochloride and to see how well it works in treating patients with stage IIIB-IV non-small     cell lung cancer.   "
154710|NCT01259076|"     Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss     affects breast density in women who are at increased risk for breast cancer.   "
154754|NCT01258504|"     The aim of the present study is to assess the impact of the cytochrome P450 2C9 (CYP2C9)     genotype (*2 and *3 allele versus wild type; ~3-5% poor metabolisers in Caucasian population)     on the pharmacokinetics of bosentan and the impact of CYP3A4-induction by St. John's wort     (SJW) on steady state bosentan which is a CYP3A4 inducer itself.   "
168629|NCT00035711|"     To evaluate additional cardiovascular risk factors using data from the VA HDL Intervention     Trial (VA-HIT).   "
154711|NCT01259063|"     The purpose of this study is to test the safety of gemcitabine applied to the bladder     directly combined with different oral doses of everolimus and to assess the right doses.     Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be     evaluated. The purpose of the phase II part is to test the combination of gemcitabine applied     to the bladder directly combined with different oral doses of everolimus and to study the     effects of these two drugs together. The investigators want to find out what effects, good     and/or bad, this treatment has on the patient and the cancer.   "
154715|NCT01259011|"     The proposed randomized controlled trial will test the SPIRIT (Sharing the Patient's Illness     Representations to Increase Trust) intervention designed to improve discussions about     end-of-life care between patients and their surrogate decision makers. Subjects will be 200     Caucasian and African-American patients with ESRD (end-stage renal disease) recruited from     outpatient dialysis clinics and their chosen surrogate decision makers. We hypothesize that     (1) SPIRIT will lead to significantly less patient decisional conflict and significantly     greater dyad congruence and surrogate decision making confidence than the standard care     control at 2, 6, and 12 months post-intervention and (2) SPIRIT will reduce surrogate     decisional conflict and psychosocial morbidities at 2 weeks after the patient's     hospitalization requiring surrogate decision making significantly more than the standard care     control.   "
154716|NCT01258998|"     This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients     with relapsed lymphoma. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
154717|NCT01258985|"     We will conduct a large randomized controlled trial comparing the effectiveness and     cost-effectiveness of Tai Chi mind-body exercise and standard-of-care Physical Therapy for     Knee Osteoarthritis.   "
154718|NCT01258972|"     The Tryton Side Branch Stent System has been designed to address the procedural difficulty     surrounding treatment of bifurcation lesions and to ensure patency of the side branch with     similar performance capabilities (e.g., tracking, radiopacity, coverage and radial strength)     that are currently available with conventional coronary stents designed for straight (non     bifurcation) lesions.      The Tryton Side Branch Stent is intended to treat and maintain patency in the side     branch/carina by providing better ostial side branch conformability and is intended for use     in conjunction with currently approved balloon-expandable drug-eluding stents for treatment     of the main branch.   "
154719|NCT01258959|"     Ophthalmic surgery on the posterior section of the eye can either be performed under general     anaesthesia or under local aneasthesia. The local anaesthesia is performed by injecting local     anaesthetics behind the eye. There are two techniques: Either the needle is placed into the     muscle cone formed by the four recti muscles - this is called intraconal or retrobulbar     block, or the needle is placed outside of the muscle cone - this would be called extraconal     or peribulbar. In our hospital the investigators usually perform the peribulbar block since     it is easier to perform and has a smaller risk to injure the eye. The investigators however     realize that the parabulbar block is sometimes very efficient and sometimes not, thus     requiring a second or third injection. Now investigators are able to visualize where the     local anaesthetics spreads with the help of ultrasound imaging. The aim of the study is to     observe and to describe the incidence of intraconal spread of local anaesthetics when a     peribulbar block is performed.   "
154720|NCT01258946|"     The aim of the present study was to search whether epicardial adipose tissue thickness, a     predictor of increased cardiovascular risk, increases in PCOS patients or not and, if it     does, to analyze the relationship of EATT with insulin resistance, adiponectin and     biochemical and anthropometric parameters.   "
154721|NCT01258933|"     The goal of this clinical research study is to find out if ofatumumab can control CLL or SLL     that is left after chemotherapy or chemoimmunotherapy. The safety of the drug will also be     studied.   "
154722|NCT01258920|"     The primary objective of this study is to evaluate the long-term safety and tolerability of     paliperidone palmitate in Japanese patients with schizophrenia. Secondary objectives of this     study are to: explore the efficacy on symptoms of schizophrenia and the maintenance of     treatment effect; explore the pharmacokinetics of paliperidone palmitate through sparse     pharmacokinetic sampling.   "
154723|NCT01258907|"     This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized,     multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care     therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as     quantified by FDG-PET/CT.   "
154724|NCT01258894|"     Studies revealed that patients with hereditary persistence of AFP also had persistent     abnormal AFP. Therefore, this study will recruit the patients and their family with elevated     AFP (>20 ng/mL) and normal AFP patients being control groups. Then, their AFP genes extracted     from the blood will be analyzed.   "
154725|NCT01258881|"     Ovarian cancer, especially epithelial ovarian carcinoma, has the highest mortality rate among     the gynecologic malignancies. The majority of patients with epithelial ovarian carcinoma are     diagnosed at advanced stage which has the overall survival rates of only 19-30%. As the     advance in the managements which prolonged the overall survival, metastatic lesion in rare     location such as brain was noted in few patients of ovarian cancer in recent years. In the     retrospective study, the investigators will review the medical records of the ovarian cancer     patients with brain metastasis in the investigators hospital to investigate the incidence,     clinical courses, optimal managements and possible prognostic factors in the rare condition.   "
154726|NCT01258868|"     Background:      - Recent research has shown that causing an immune response to tumor cells may help slow or     stop the growth of tumors. One treatment that has come from this research involves collecting     and modifying a cancer patient's tumor cells in the laboratory, then returning the cells to     the patient as a vaccine to encourage the immune system to respond to them. Researchers are     interested in testing tumor cell vaccines with an experimental drug called ISCOMATRIX , which     can be added to a vaccine in order to elicit a stronger immune response in the body.     ISCOMATRIX has not been approved for sale and use in any country and its use is still     experimental, though it has been tested and used safely in other clinical studies.     Researchers are also interested in determining whether the anti-inflammatory drug celecoxib     will improve the body's immune reaction if given with the vaccine.      Objectives:      - To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and     celecoxib in the treatment of lung and esophagus cancers.      Eligibility:        -  Individuals at least 18 years of age who have primary small cell or non-small cell lung          cancer, esophageal cancer, or pleural mesothelioma that can be removed by surgery.        -  Only individuals whose tumor cells are able to produce a tumor cell line for vaccine          development will be eligible for treatment.      Design:        -  Participants will be screened with a physical examination and medical history, and will          have tumor tissue collected during their surgery to determine whether the tumor cells          can be used to produce a vaccine.        -  Participants will take celecoxib twice daily for 7 days before having the first tumor          cell vaccination. Participants will also have leukapheresis to collect blood cells for          testing before the first vaccination.        -  Participants will receive one vaccine (which may be given in two shots) monthly for 6          months, and will continue to take celecoxib twice daily. One month after the 6th vaccine          shot, participants will have another leukapheresis and skin test. If these tests show          that a participant is responding to the vaccine, additional vaccines will be given every          3 months for up to 2 years.        -  Participants will have a physical exam and lab tests before each vaccination, blood          samples and imaging studies every 3 months, and a skin test every 6 months.        -  Participants will have regular followup visits with imaging studies and blood samples          for up to 5 years after the first vaccination, or until a new tumor develops....   "
160392|NCT01184144|"     The purpose of this study is to compare the effect of pioglitazone versus no drug on soluble     profinflammatory markers in peritoneal fluid of women with endometriosis.   "
154727|NCT01258855|"     This randomized phase II trial studies how well aldesleukin with or without ziv-aflibercept     works in treating patients with stage III-IV melanoma that cannot be removed by surgery.     Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the     growth of melanoma by blocking blood flow to the tumor. It is not yet known whether     aldesleukin is more effective with or without ziv-aflibercept in treating melanoma.   "
154728|NCT01258842|"     To determine if prophylactic supplementation with B. lactis HN019 reduces the risk of     developing physician- and laboratory-confirmed influenza infection at any time during the     12-week supplementation period.   "
154729|NCT01258829|"     Many patients who have cardiac resynchronisation therapy (a type of pacemaker) implanted for     heart failure do not have the settings of their device optimised. The most widely available     method for optimisation uses flow measured using cardiac ultrasound (echocardiography) to     determine the optimal settings. However, this is not frequently performed because it is time     consuming and requires two skilled operators. In this study the investigators will test a new     non-invasive method for optimisation, which utilises pressure measurements (non-invasive     blood pressure measured from the finger).      Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms     of exercise capacity, to conventional echo optimisation.   "
154730|NCT01258816|"     The purpose of the study is to investigate the pharmacokinetics (PK) and cardiac properties     of elacytarabine in patients with relapsed or refractory Acute Myeloid Leukaemia (AML). The     efficacy and tolerability of elacytarabine will also be assessed.   "
154731|NCT01258803|"     A study to compare the bronchodilatory effect of a single dose of Mometasone     Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and     without an AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer) versus     Placebo MDI (combined with and without spacer) and formoterol fumarate (F) dry powder inhaler     (DPI). Participants were randomly assigned to 1 of 6 treatment sequences and each participant     was to receive a single dose of each of 4 treatments in each period. Each treatment period     was separated by a 5 to 7 day washout period. It assumed that a single dose MF/F MDI 100/10     microgram (mcg) delivered with a spacer would produce bronchodilation, defined as a     significant increase in forced expiratory volume in one second (FEV1) area under the curve     from 0 to 12 hours (AUC[0-12 hr]) when compared to placebo.   "
154732|NCT01258790|"     Specific Aim1: Using a paradigm of Transcranial Magnetic Stimulation called Continuous Theta     Burst Stimulation (cTBS) to reduce tics in Tourette Syndrome subjects      Hypothesis1: cTBS, compared to sham stimulation, will reduce tic severity by at least 25% as     measured by the Yale Global Tic Severity Scale      Specific Aim2: Using cTBS to further understand neural correlates of tic generation      Hypothesis2: Functional MRI BOLD signal activation pattern will change after cTBS and this     change will correlate with clinical improvement in tic severity   "
154733|NCT01258777|"     The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and     Caucasian Males.   "
154734|NCT01258764|"     The purpose of this trial is to evaluate if an objective clinical decision of     anti-hypertensive therapy can be made using an N-of-1 (single patient) trial design.   "
154735|NCT01258751|"     The purpose of this study is to evaluate the relationship between plasma drug levels and     receptor binding in brain using PET; and to evaluate safety and tolerability after a single     administration of PF-05212377 in healthy volunteers   "
154736|NCT01258738|"     This is a two part study. During period one there will be a comparison of Etanercept (ETN)     against a placebo with both arms maintaining the background anti inflammatory drug prescribed     by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as     determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis     (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone     in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory     drug(NSAID).   "
154737|NCT01258725|"     The aim of this study is to compare the uteroplacental and pulmonary circulation of the     fetuses with severe (AFI<5cm) idiopathic oligohydramnios (with unknown origin) to those in     normal controls. Further purpose of the study is to measure the changes of the uteroplacental     and fetal pulmonary circulation in patients presenting with severe idiopathic     oligohydramnios, managed either with single amnioinfusion or with serial amnioinfusions.   "
154738|NCT01258712|"     This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with     Rheumatoid Arthritis.   "
154739|NCT01258699|"     This study is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab     600mg in Healthy Adult Male Subjects.   "
154740|NCT01258686|"     The purpose of this study is to determine the effectiveness of silymarin 700 mg thrice daily     and assess the safety in patients with hepatitis C virus infection compared to a placebo.   "
154741|NCT01258673|"     The purpose of this study is to evaluate the antihypertensive efficacy and safety of     Fimasartan/Hydrochlorothiazide combination 60/12.5mg~120/12.5mg in patients with essential     hypertension who are not controlled by fimasartan 60mg.   "
154743|NCT01258647|"     Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer     from stunting of linear growth by 12 months of age. Stunting presumably results from breast     milk supplementation after 6 months of age with complementary foods (CF) that provide     inadequate protein and micronutrients. Although supplementation with selected micronutrients     may avoid certain deficiency states, CF with animal source foods may be necessary to avoid     stunting. Meat is not readily available in many Central African countries. However     caterpillars, which are locally available and abundant, are a common staple in adult diets     and may be a suitable substitute for animal source proteins in CF. The investigators     developed a cereal made from dried caterpillars that has a nutrient content that appears to     be ideal for CF. Maternal and infant acceptability will be evaluated in 20 mothers and their     8 month old infants. The investigators hypothesize that this cereal will be accepted by both     mothers and infants: acceptability will be based on a priori definitions.   "
154771|NCT01256541|"     To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas     levels in patients requiring bowel evacuation, and also to determine the safety, efficacy,     and patient preference of Kristalose as a bowel evacuant   "
160857|NCT00000297|"     The purpose of this study is to investigate the effects of labetalol in response to     intravenous nicotine   "
154744|NCT01258634|"     This is a pilot study that will allow investigators to collect data related to early and     potentially more accurate response assessments using a chemotherapy protocol that eliminates     methotrexate to maximize the dose intensity of doxorubicin. The pilot data will be used to     seek funding to more fully address the hypotheses in a multi-institutional, Phase II or Phase     III trial. The primary and secondary objectives are as follows:      Primary:        1. To evaluate the feasibility and potential usefulness of measuring early changes in tumor          metabolic activity, assessed by Fludeoxyglucose-Positron Emission Tomography (FDG-PET)          imaging and alkaline phosphatase activity, as early predictors of histological response          rate at 12 weeks in osteosarcoma patients.        2. To explore whether histological response can be assessed by a computer algorithm using          virtual microscopic images of pathology material, and whether quantifying necrosis in          this way correlates with microscope slide-based review.      Secondary:      1. To gather pilot data on the histological response rate, 3-year event-free survival, and     toxicity when children and young adults with resectable osteosarcoma are treated using a     chemotherapy regimen of alternating courses of doxorubicin/cisplatin (DC) and     doxorubicin/ifosfamide/etoposide (IDE).      All patients will receive 4 courses of preoperative chemotherapy courses. With the exception     of high-dose methotrexate, which is given weekly, preoperative and postoperative chemotherapy     courses are planned to begin every 21 days.      Patients with good histological response (those patients with > 90% tumor necrosis at time of     definitive resection) will receive three postoperative chemotherapy courses. The 1st will     consist of doxorubicin, dexrazoxane, cisplatin and Granulocyte-Colony Stimulating Factor     (G-CSF)(or Polyethylene Glycol filgrastim). The 2nd course will consist of doxorubicin,     dexrazoxane, ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastim). The 3rd course will     consist of ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastrim). The total doxorubicin     dose will be 450 mg/m2.      Patients with poor response (those patients with < 90% tumor necrosis found on pathology at     time of definitive resection) will receive five postoperative chemotherapy courses. High     Dose-Methotrexate will be administered during the 1st and 3rd postoperative chemotherapy     courses as 4-weekly and 2-weekly doses, respectively. The 2nd course will consist of     doxorubicin, dexrazoxane, cisplatin and G-CSF (or PEG-filgrastim). The 4th course will     consist of doxorubicin, dexrazoxane, ifosfamide, Mesna, etoposide, G-CSF (or PEG-filgrastim).     The 5th cycle will consist of ifosfamide, Mesna, etoposide, G-CSF (or PEG-filgrastrim). The     total doxorubicin dose will be 450 mg/m2.   "
154745|NCT01258621|"     Laparoscopic distal pancreatectomy (LDP) for benign and borderline pancreatic lesions has     recently becoming the treatment of choice in experienced centres. No data have been published     about learning curve so far. The purpose of this study was to identify the learning curve     period for performing LDP.   "
154746|NCT01258608|"     Mapatumumab is a fully human, agonist monoclonal antibody that activates the cell death     pathway in tumor cells by specifically binding to TRAIL-R1 with high affinity. Sorafenib, a     multikinase inhibitor, is the standard of care for treatment of patients with advanced     hepatocellular carcinoma (HCC). The mechanisms of sorafenib and mapatumumab action suggest     that these agents could interact synergistically. This is a Phase 2, multi-center,     randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of     mapatumumab in combination with sorafenib in subjects with advanced hepatocellular carcinoma.   "
154747|NCT01258595|"     The aim of the study is to generate data on key parameters associated with assessment of     influenza vaccines in individuals 50-64 years of age      Primary Objective:        -  To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine          (TIV) compared to TIV.        -  To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as          assessed by solicited adverse reactions collected for 7 days post-vaccination, and          unsolicited adverse events (including Serious Adverse Events and Adverse Events of          Special Interests) collected between Visit 1 and Visit 2   "
154748|NCT01258582|"     This study was initially designed to compare the effectiveness of two different approaches to     providing routine HIV counseling, testing, and referral services in an urban hospital     emergency department setting. The initial phase was closed in July 2008. The second phase of     this trial consists of establishing the differences in acceptability of HIV testing based on     the method of testing offered (rapid oral fluid vs. fingerstick).   "
154749|NCT01258569|"     Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been     shown to increase postoperative bowel function in patients after open bowel resection     surgery. It has been proven safe and effective for short-term in-house treatment. At the     present there are several Drug Use Utilization Evaluation studies reporting results involving     the use of alvimopan (ENTEREG) in laparoscopic bowel resection patients. However, this study     will be the first randomized, prospective, double-blind, placebo-controlled trial looking at     this population. We propose that Entereg will decrease the length of stay by one day in the     laparoscopic colon resection patient. We wish to perform a voluntary, double-blinded, placebo     controlled study. We plan an enrollment population of 250 patients. Twelve milligrams of     Entereg will be administered 30 minutes to 5 hours pre-op followed by 12 mg BID, up to 7 days     or 15 total doses. The primary endpoint of the study will be length of stay. The time of GI-2     recovery (toleration of solid food and first bowel movement) and time to GI-3 recovery     (toleration of solid food, and flatus or bowel movement) will be secondary endpoints.      Estimated Enrollment = 250, Study Start Date: November 2010, Estimated Study Completion Date:     May 2012, Estimated Primary Completion Date: Nov 2011.   "
154750|NCT01258556|"     Purpose of the proposed research is to determine the impact of probiotic yogurt supplemented     with Lactobacillus rhamnosus (Fiti) compared to regular yogurt on the well-being of women     living with HIV.   "
154751|NCT01258543|"     The purpose of this study is to determine whether two osteopathic evaluators with less than 5     years experience will be able to determine the same location and nature of the primary     lesion(s) or restriction(s)in patients with chronic non-specific back pain using a global     osteopathic evaluation approach.   "
154752|NCT01258530|"     This is a study in healthy adult volunteers to assess the bioequivalence of over-encapsulated     oseltamivir capsules to commercially available oseltamivir capsules. Both formulations will     be administered in the fasting state.   "
154753|NCT01258517|"     The purpose of this study is to assess changes in cerebral oxygenation during two different     types (beractant and poractant) and two different routes (double lumen or single lumen     endotracheal tube) of surfactant administration using near infrared spectroscopy (NIRS).   "
154755|NCT01258491|"     The study will be a double-blind, randomized, placebo-controlled, single-center, 2     treatment,3-way crossover to investigate the pharmacodynamics, i.e. the flush-symptom of a     single oral repeated dose of 500 mg nicotinic acid in healthy subjects. Subjects will be     randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be:        -  Treatment A: 500 mg nicotinic acid        -  Treatment B: Placebo   "
154756|NCT01258478|"     Patients suffering from non small cell lung cancer(NSCLC), depend upon lung removal to     increase their chances of survival. But, this type of surgery cannot be advised to patients     with significant heart disease, limited lung fuction or reduced physical fitness. Intensive     physical training has been shown to increase aerobic fitness in healthy subjects.      The purpose of this study is to determine the effect of a short term rehabilitation prior to     surgery on the post-operative and physiological outcomes for patients undergoing this type of     surgery.   "
154757|NCT01258465|"     The purpose of this research project was to systematically compare two widely used types of     intervention programs for children with autism within a parent training model. In one     condition, randomly assigned children were provided with an intervention that typically     results in acquisition of expressive words in a large percentage of children diagnosed as     having autism, using a well-documented manualized intervention focused on verbal expressive     communication only (Pivotal Response Training, PRT). In the other condi¬tion, randomly     assigned children received a widely used intervention on the same social communication     functions using a well-documented manualized augmentative system of intervention (Picture     Exchange Communica¬tion System, PECS) that has been reported to produce verbal and nonverbal     communication in large percentages of children diagnosed with autism. Children in the two     conditions were compared for development of verbal and nonverbal communication, changes in     disruptive behavior, changes in symptoms of autism, and general adaptive behavior gains. In     addition, parent satisfaction and stress measures were gathered in order to assess the     effects of each intervention on family functioning.   "
154758|NCT01258452|"     To evaluate the effects of a high-calorie high-fat meal on the extent and rate of absorption     of CHF 5074 after single oral administration in young healthy male volunteers.   "
154759|NCT01258439|"     This is a research study into the effects of three drugs used to treat HIV infection. Some     drugs used to treat HIV have been associated with changes in blood fats such as cholesterol     that could be harmful over the long-term, because these blood fat changes have been     associated with a small, increased risk of heart disease and stroke in some studies of adults     with HIV. Now that HIV can be controlled for long periods in most patients, and because heart     disease is one of the biggest causes of illness and death in the general population, it is     important to develop new HIV treatments that control HIV effectively but do not cause     abnormal blood fats.      Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than     ritonavir-boosted darunavir.   "
154760|NCT01256684|"     The purpose of this Phase III trial is to confirm the efficacy of intravaginal     dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.   "
154761|NCT01256671|"     The purpose of this Phase III trial is to assess the long-term safety of intravaginal     dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal     atrophy aged 40 to 75 years.   "
154762|NCT01256658|"     This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and     treatment of asymptomatic carriers of malaria parasites (P. falciparum) with COA566 on a     number of clinical malaria cases in children less than 5 years of age and the improvement of     hemoglobin levels in the overall population.   "
154763|NCT01256645|"     The aim of this study is to determine, whether a liberal transfusion strategy is helpful to     liberate patients from prolonged invasive mechanical ventilation.      Patients who are difficult to wean according to the criteria by Boles et al [1] are limited     by the capacity of their respiratory muscles.      Improved oxygen delivery achieved by blood transfusions however is known to decrease the work     of breathing [2] and thus in theory can improve weaning success [3].      This study is designed as a prospective, randomized, open labeled blinded End-point     evaluation to test the hypothesis that a liberal transfusion strategy decreases the time     needed for weaning.        1. Boles, JM, J Bion, A Connors, M Herridge, B Marsh, C Melot, R Pearl, H Silverman, M          Stanchina, A Vieillard-BaronandT Welte, Weaning from mechanical ventilation. Eur Respir          J, 2007. 29(5): p. 1033.        2. Schonhofer, B, M Wenzel, M GeibelandD Kohler, Blood transfusion and lung function in          chronically anemic patients with severe chronic obstructive pulmonary disease. Crit Care          Med, 1998. 26(11): p. 1824.        3. Schonhofer, B, H BohrerandD Kohler, Blood transfusion facilitating difficult weaning          from the ventilator. Anaesthesia, 1998. 53(2): p. 181.   "
154764|NCT01256632|"     The primary objective:      *To measure the difference in the number of Ranibizumab therapies needed in 12 months in the     Posterior Vitreous Detachment (PVD) positive and Posterior Vitreous Detachment (PVD) negative     group.      Secondary Objective:        -  To measure the mean change in visual acuity from Baseline to Month 12.        -  To measure the mean change in central retinal thickness per OCT from Baseline to Month          12   "
154765|NCT01256619|"     The desogestrel (150 mg) in combination with ethinyl estradiol (EE, 30 mg) is known as     Marvelon in European countries. Previous studies revealed that the Marvelon is good and safe     for women. As a study from Thailand showed that the Marvelon to be effective and acceptable     in Thai women. Moreover compared to Caucasian women, the incidences of irregular bleeding and     side effects were apparently lower in these Asian women . Although Marvelon was used in many     countries but it's efficacy didn't reported among Iranian women.   "
154766|NCT01256606|"     The purpose of this study is to develop and evaluate a blood test for pregnant women for     detection of fetal aneuploidy.   "
154767|NCT01256593|"     The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in     medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in     subjects treated with Lyrica will be monitored during the survey period, and whether an     additional treatment outcome investigation and/or a post-marketing clinical study is required     in the future will be determined.   "
155314|NCT01250938|"     The purpose of this study is to test the applicability of a caregiver-implemented autism     intervention protocol to a deliberately recruited low-income, underserved population.   "
154768|NCT01256580|"     Anti-VEGF therapy has been proven efficacious for the wet (neovascular) form of macular     degeneration and may be beneficial for the treatment of choroidal neovascularization (CNV)     due to other causes. The limitation of this type of treatment is the necessity for frequent     intraocular injections. The purpose of this study is to determine if using anti-VEGF therapy     in combination with photodynamic therapy can reduce the number of treatments needed with     monotherapy while achieving similar visual results. There are ongoing multicenter trials     evaluating combination therapy in patients with wet AMD but no similar trial for patients     with CNV due to non-AMD causes. Therefore, in this study the investigators will focus on     patients with CNV not due to AMD.   "
154769|NCT01256567|"     The primary objective of this study is to investigate the safety and tolerability of the     anti-VEGFR-2 monoclonal antibody ramucirumab drug product in combination with docetaxel in     Japanese participants with metastatic, or locally advanced breast cancer, with the aim of     confirming the recommended dose of ramucirumab drug product (DP) in combination with     docetaxel.   "
154772|NCT01256528|"     The goal of this clinical research study is to learn if delayed-delayed breast reconstruction     in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and     result in fewer complications compared to the standard approach (reconstruction that is not     started until radiation treatment is completed).   "
154773|NCT01256515|"     The goal of this study is to assess the immunogenicity of inactivated influenza vaccination     (IIV) in healthy elderly volunteers aged 50 years and older receiving one of two different     health management trainings.   "
154774|NCT01256502|"     The purpose of the study is to obtain clinical experience with the use of SERI® Surgical     Scaffold for tissue support and repair in breast reconstruction.   "
154775|NCT01256489|"     The proposed study is intended to test the idea, based upon current knowledge of the biology     and physiology of corneal ulceration in SJS/TENS patients who receive a keratoprosthesis, and     on the known effects of infliximab on matrix metalloproteinases, that infliximab therapy for     such patients may reduce the likelihood of corneal ulceration, and hence extend the period of     prosthesis retention and vision recovery.   "
154776|NCT01256476|"     Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg     daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed     dyslipidemia.   "
154777|NCT01256463|"     The rapid scale-up of HIV care and treatment in resource-limited settings provides the     opportunity to reach many HIV-positive individuals with prevention messages and interventions     in care and treatment settings. However, HIV prevention is rarely incorporated into the     routine care and treatment of people living with HIV, leaving missed opportunities to reach     patients with critical interventions.      This study will evaluate an HIV prevention intervention package for health care settings in     sub-Saharan Africa. The HIV prevention intervention will be delivered to HIV-seropositive     patients in HIV care and treatment clinics during all routine visits. Health care providers     (HCPs) will deliver HIV prevention messages on correct and consistent condom use, disclosure     of serostatus, partner HIV testing, adherence and alcohol reduction. They will also assess     and treat sexually transmitted infections (STIs) and provide basic contraceptives and safer     pregnancy counseling.      Trained lay counselors (LCs) will deliver HIV prevention interventions in the clinics. LCs     will be persons without medical training, many of whom will be PLHIV, who will be trained to     provide HIV prevention counseling, promote HIV testing of partners and children (and provide     HIV testing where allowed by national guidelines), and counsel HIV-positive patients on     medication adherence and alcohol use.      The prevention intervention package will be evaluated in HIV clinics in three sub-Saharan     African countries: Kenya, Namibia, and Tanzania. This project will be a longitudinal     group-randomized trial with 9 intervention clinics (3 per country) and 9 comparison clinics     (3 per country). Two hundred patients per clinic (total N = 3600) will be followed for 12     months. This evaluation will examine the effectiveness of the HIV prevention interventions     delivered by HCPs and LCs on patient-level outcomes such as risky sexual behavior, disclosure     of HIV status, partner HIV testing, alcohol use, HIV antiretroviral (ARV) medication     adherence, STI treatment, pregnancies, and contraceptive use.      In addition to the patient outcomes, the acceptability of the interventions and materials, as     well as the feasibility of integrating the interventions into HIV care and treatment     settings, will be assessed.      Data will be collected via patient interviews, HCP and LC questionnaires, observations of HCP     and LC patient visits, patient medical chart review, and review of clinic service data.   "
154778|NCT01256450|"     The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal     film is effective and safe in the treatment of chronic low back pain (CLBP).   "
154779|NCT01258426|"     Recently, seslenium(Se) has known as important regulator in metabolic status, lipid profile,     atherosclerosis progression. SEPP1(selenoprotein P1)is a secreted protein from mainly liver.     This protein is used as an index of selenium nutritional status. The association between the     concentration of SEPP1(selenoprotein P1) in normal glucose tolerance,impaired glucose     tolerance, type 2 diabetes is still a matter of debate. This cross sectional study will     evaluate whether glucose status is matter in SEPP1 level.   "
154780|NCT01258413|"     The purpose of this study is to determine whether laparoscopic radical hysterectomy for early     cervical cancer will has decreased postoperative pain intensity compared to abdominal radical     hysterectomy with similar postoperative complications and survival rates.   "
154781|NCT01258387|"     Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single     intravenous administrations of GGF2 in patients with heart failure.   "
154782|NCT01258374|"     While 3-drug regimens remain standard of care, concerns exist regarding the safety of     multi-drug regimens taken for a lifetime. Problems with nucleoside analogue therapy prompted     successful trials with ritonavir (RTV) boosted PI monotherapy, however long term safety and     efficacy of such regimens remains unknown. Clinical trials have shown Raltegravir (RAL) to     have potent activity when patients have few active background drugs; it has a superior lipid     profile compared with EFV and LPV/RTV. Darunavir/r (DRV) is a potent, well tolerated PI with     few GI side effects and lipid disturbances and with a high genetic barrier. The investigators     hypothesized that RAL/DRV would be a well tolerated and effective regimen for those patients     who are failing nucleoside reverse transcriptase inhibitors based regimens, due to poor     tolerability or resistance. The investigators also would like to explore the plasma     pharmacokinetics of Raltegravir combined with Darunavir in a sub-group of 12 HIV-infected     patients.   "
154783|NCT01258361|"     The primary objective of this study is to demonstrate that preoperative fasting does not     increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg     lift) in patients undergoing surgery.   "
154786|NCT01258322|"     1. Background:Cardiovascular disease (CVD) is the major cause of mortality in peritoneal          dialysis (PD) patients, in whom it is partly attributable to a higher prevalence of          dysmetabolism. Currently, few treatments are available with a proven effect on          dyslipidemia, insulin resistance and inflammation in this patient group.        2. Study design: Randomized, cross-over trial.        3. Settings and Participants: Prevalent PD patients (＞20 years old, s-triglycerides ＞1.8          mmol/L) who had never received glitazones were enrolled.        4. Interventions: Participants were randomized to receive either oral pioglitazone (PIO; 15          mg once daily) and no pioglitazone, both for 12 weeks and in random order, with a          four-week wash out in between.        5. Outcomes and measurements: The primary endpoint was change of serum triglyceride (TG)          level during the PIO as compared to no PIO. Secondary endpoints included changes in          other lipid levels, HOMA-IR, adipocytokines and CRP. Outcome effects were assessed using          a GLM.   "
154787|NCT01258309|"     This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac     tromethamine fixed dose combination ophthalmic solution compared with olopatadine     hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.   "
154801|NCT01258127|"     The main purpose of this randomized phase II trial is to evaluate the clinical feasibility     and activity of administering adjuvant chemotherapy of pemetrexed/carboplatin compared with     vinorelbine/carboplatin in patients with completely resected non-small cell lung cancer     (NSCLC).   "
160885|NCT00000325|"     To determine if acute assessments of profasi and factrel affect plasma cocaine levels and     cocaine-induced behavioral changes in men.   "
154788|NCT01258296|"     The aim of this randomized, double-blind controlled trial is to determine the efficacy of     transdermal fentanyl for the management of early postoperative pain in women undergoing     mastectomy followed by immediate TRAM or DIEP flap reconstruction. We will examine whether     the use of the fentanyl patch as a bridge between epidural and oral analgesia will improve     overall pain relief compared to placebo patch. We further propose to study whether the     fentanyl patch is associated with improved ability to sleep, patient satisfaction, and     functional capacity at one week, and whether it is associated with different side effects     than standard therapy without the patch. Following informed consent, patients will undergo     mastectomy and reconstruction, and receive epidural fentanyl for initial postoperative     analgesia. Patients will be randomized to active (25 mcg/hr Duragesic) or placebo patches on     postoperative day three, and the epidural will be weaned over the next 12 hours. Pain     intensity scores and relief from pain will be assessed every day while in the hospital and     oral and IV opioid use recorded. Patients will be discharged to home with a supply of 2     patches and oral medication, and will be asked to fill out a daily pain and medication log.   "
154789|NCT01258283|"     The main objective of this study is to determine among the patients included a subpopulation     that does not need a defibrillator.      This will be done by comparing the number of discordant segments (mismatch) between patients     who have a severe arrhythmia (ventricular tachycardia or ventricular fibrillation) with     appropriate electrical therapy within 3 years of monitoring and others. Mismatch in the     definition of this objective is the usual definition: score 3.4 in I123-MIBG (Iodine 123     metaiodobenzylguanidine) and PET at 0,1,2.   "
154790|NCT01258270|"     The objective of this study is to determine the safety and effectiveness of the AQUACEL® Ag     Surgical Dressing (treatment group) as compared to prepackaged island wound dressings     consisting of traditional tape and gauze (control group) for total hip and total knee     arthroplasty.   "
154791|NCT01258257|"     The intention of the study is to investigate whether drainage of cerebral spinal fluid via a     lumbar route (Tuohy-drain) will improve outcome after intracranial aneurysmal subarachnoid     hemorrhage (SAH).   "
154792|NCT01258244|"     The quality of cardiopulmonary resuscitation (CPR) provided to patients with out-of-hospital     cardiac arrest (OHCA) is often suboptimal. There now exist monitors/defibrillators that allow     for the measurement and real time feedback of the quality of chest compressions and     ventilations. In addition to giving the prehospital provider the benefit of real time CPR     quality feedback via voice and visual cues, the CPR quality data acquired using these devices     can be utilized as part of an on-going quality assurance/quality improvement program.      The first objective of the proposed project is to quantify the quality of chest compressions     and ventilations provided in the state of Arizona to patients with OHCA and to determine     whether the quality of CPR is related to patient outcome from OHCA.      A second objective of this project is to determine whether use of audiovisual feedback     improves both CPR quality and patient outcome in the pre-hospital setting.   "
154793|NCT01258231|"     This study aims to identify genetic causes of adverse events after cardiac surgery, such as     atrial fibrillation, myocardial infarction, renal dysfunction and heart failure.      Patients undergoing heart surgery at Brigham and Women's Hospital and Texas Heart Institute     are eligible to participate.   "
154794|NCT01258218|"     The intent of this study is to evaluate the performance of the implanted Accent MRI TM system     in a clinical setting and optionally in the MRI environment. This system includes the St.     Jude Medical Tendril MRI™ lead and SJM Accent MRITM DR pacemaker. Also the MRI Activator™     will be evaluated in this study. The MRI Activator is a handheld device that allows the user     to enable and disable MRI Settings as well as check the status of MRI Settings in the     pacemaker. The patient population under study includes patients with a standard bradycardia     pacing indication.   "
154795|NCT01258205|"     The purpose of this study is to assess the safety and tolerability of AMG 139 following     multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in     subjects with mild to severe Crohn's disease (CD).   "
154796|NCT01258192|"     The purpose of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy     with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.   "
154797|NCT01258179|"     The purpose of this study is to analyze the peri-operative expression of pancreatic stone     protein and pancreatitis-associated protein in surgical patients following major abdominal     surgery by blood samples.   "
154798|NCT01258166|"     Ulnar translocation of the carpus is a form of wrist instability where the small bones of the     wrist shift out of position. It is well recognized in patients with rheumatoid arthritis, but     can also occur after a traumatic event, such as a violent football tackle or a fall from a     height. The treatment options vary considerably, and there is no consensus of how to best     address this injury pattern.      Because traumatic ulnar translocation is relatively rare, the diagnosis may be missed or     delayed, causing problems for the patient such as persistent pain and loss of function. The     investigators present 11 cases of this injury, discuss how to recognize it, and report our     results after different treatment methods.   "
154799|NCT01258153|"     This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind,     placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and     safety of Nepadutant given at two oral doses once daily for seven days in comparison to     placebo in the treatment of infantile colic.   "
154800|NCT01258140|"     Computed tomography pulmonary angiography (CTPA) is the imaging method of choice to rule out     acute pulmonary embolism based on its high sensitivity and specificity. Unfortunately, CTPA     uses iodinated contrast media and can provoke contrast induced nephropathy. On the other     hand, Computed tomography uses ionising radiation and is responsible for the half of the     radiation exposure coming from medical sources.      Recent studies have proven that low-dose CTPA protocols using Computed tomography tube energy     of 80 kVp and reduced volume of iodinated contrast media provide an increased vessel signal     and good image quality at a significantly reduced patient exposure. However, there are no     data on the sensitivity of low-kVp protocols.      The aim of this prospective randomized trial is to detect any difference between a     normal-dose and a low-dose CTPA protocol in the diagnostic accuracy in the detection of acute     pulmonary embolism (PE).   "
160917|NCT00000357|"     The purpose of this study is to determine the efficacy of buprenorphine as a substitution     pharmacotherapy for opiate dependence.   "
154802|NCT01258114|"     Public health campaigns and industry-supported changes in our food supply have obviously     failed to control the epidemic to date. However, customized life style modification programs     (LSMP) comprising diet, physical activity and behavioral therapy (a set of principles     designed to help patients achieve their goals) induce weight loss of 10% of baseline body     weight after 16 to 26 weeks of intervention . Long-term weight control is then facilitated by     an appropriate weight-loss maintenance strategy such as continued patient-therapist contact     (whether provided in person or by telephone or e-mail). This strategy allows patients to     stabilize at an average of 5% and 3% loss of baseline body weight after 1 and 2 years,     respectively. Numerous reports have concluded that this modest weight loss contributes to     important health benefits.      However, the high dropout rate during weight-management strategies presumably means that     treatment is mainly effective in highly motivated patients, as the highest success rates are     likely to be reported among study completers. Many individuals appear to conclude that the     benefits of weight-management strategies are not worth the cost (i.e. time, money, and     continued unrewarding efforts). This underlines the critical need to implement new, practical     and affordable strategies to induce and maintain weight loss that can be achieved by most     patients.      The main objective of this study is to test the hypothesis that a 3 week intensive course of     spa therapy can reduce the weight (and/or BMI) of overweight or obese patient at 14 months     (BMI from 27 to 35).   "
154803|NCT01258101|"     This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys     (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with     chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups     receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two     doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment     is 16 or 24 weeks with a 24-week follow-up.   "
154804|NCT01258088|"     The purpose of this study is to determine how much drug is absorbed throughout the body after     being applied to the skin.   "
154805|NCT01258075|"     Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM)     to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have     been treated with Metformin or have had no antidiabetic drug treatment in the previous three     months.      Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well     tolerated, and shows improved blood sugar control (as evidenced by a significant change from     baseline in hemoglobin A1C [HbA1c]).   "
154806|NCT01258062|"     This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal     powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of     age who are eligible for study participation will be enrolled in the trial. It is expected     that 10 subjects will be screened to obtain 7 subjects who will be eligible for study     participation.      The primary objective is to determine the frequency and severity of local and systemic     adverse events of vaccine.      The secondary objective is to assess the immunogenicity of the vaccine based on geometric     mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.   "
154807|NCT01258049|"     The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is     better than intravenous quinine in reducing parasite counts by >= 90% within 24 hours after     the start of treatment in children with severe malaria, or uncomplicated malaria with     gastrointestinal complications   "
154808|NCT01258036|"     The aim of this study is to analyze the hereditary determinism of bone microarchitecture     measured at the distal radius and distal tibia from a case control-study of mother-daughter     pairs.   "
154809|NCT01258023|"     The trial investigates the efficacy of adjuvanted seasonal influenza including H1N1 Fluad (R)     in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It     is expected that when administered once the vaccine fulfills all serological efficacy     criteria required for the elderly population age 60 years and older.   "
154810|NCT01258010|"     Spinal surgery may be associated with substantial blood loss which often requires erythrocyte     transfusion. Transfusion of red blood cells (RBC) is not free of adverse events and has been     associated with increased risks of infection, and globally higher morbidity and mortality.      Different techniques have been used to reduce perioperative blood losses and related     transfusions. Tranexamic acid has been used successfully in cardiac and hepatic surgery.     However, only a few studies have reported on the use of antifibrinolytic drugs in spinal     surgery.      This study was designed to assess the efficacy and safety of tranexamic acid in spinal     surgery for the reduction of RBC transfusion.      Hypothesis: the infusion of tranexamic acid during spinal surgery will reduce the risk of     receiving a RBC transfusion and, in those patients transfused, reduce the number of blood     products administered.   "
154811|NCT01257997|"     This pilot study is using a novel technology to measure the rate of turnover of new fat     cells. Analysis of volunteer samples is ongoing, however the study is currently not enrolling     new volunteers.   "
154812|NCT01257984|"     The objective of the study is to evaluate the effect of the dispenser's buzzer function on     compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP)     containing oral contraceptive (OC) in a flexible extended regimen when administered for     approximately 12 months to healthy female volunteers who request contraception.   "
154813|NCT01257971|"     This is a multi-centre non-interventional study of patients who are treated with any HMGCoA     reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and     fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in     accordance with SmPCs approved in Croatia. Data collection for each patient will take place     at a single visit. The investigator will complete a Case Report Form with the patient's     demographics, the presence of the factors for high cardiovascular risk, current treatment,     cholesterol values as well as with further treatment decision.   "
154814|NCT01256892|"     To evaluate the impact of induction of labour at 38 weeks with the induction of labour at 40     weeks in women with insulin dependent gestational diabetes mellitus on maternal and fetal     outcome.   "
154848|NCT01257568|"     This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip     replacement (THR) with a cementless application in a consecutive series of patients who meet     the eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years     and clinical outcomes for up to 10 years after surgery.   "
154815|NCT01256879|"     The purpose of this research is to see if non-drug ingredients in capsules and oral solutions     affect how well drugs are absorbed. This is called bioequivalence. Medications taken by     mouth, such as capsules and solutions, need to be absorbed into the body in order to do any     good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are     called excipients or fillers. Excipients in the capsules and solutions can impact how much     drug is absorbed into the body. This is called bioINequivalence. Capsules and solutions in     this research contain the drug cimetidine. This drug is being used since it has high water     solubility (can dissolve in water) and low ability to be absorbed.   "
154816|NCT01256866|"     The aim of this prospective randomized study is to compare the safety and efficacy of two     strategies for sedation of critically ill patients submitted to mechanical ventilation:     continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam. The     two groups will be compared as to the incidence of of delirium, evaluated with the Confusion     Assessment Method for ICU (CAM-ICU) and the percentage of time within the target sedation     using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18 years or     older intubated and mechanically ventilated for less than 48 hours prior to start of study     drug and anticipated ventilation duration of at least 48 hours. Calculated sample size is 146     patients (73 patients in each group)   "
154817|NCT01256853|"     This is a phase I, dose escalation trial of MVA-EBNA1/LMP2 vaccine across a pre-defined range     of doses in patients in remission having had an EBV+ nasopharyngeal carcinoma (NPC).   "
154818|NCT01257958|"     Phase 1 study of 19-nor Vitamin D in relapsing-remitting MS. Primary measure is MRI.   "
154819|NCT01257945|"     This randomized, controlled exercise intervention with three groups compares two exercise     approaches to standard of care. Supervised interventions are administered for four months,     with emphasis on patients adopting exercise habits to continue to exercise for an additional     12 months. Functional outcomes are measured at the completion of the supervised exercise (4     months) as well as 10 and 16 months.   "
154820|NCT01257932|"     The investigators have developed imaging protocols to monitor and predict breast cancer     response to neoadjuvant chemotherapy, both prior to and as early as possible during the     course of treatment.      The efficacy and practicality of conventional imaging approaches in the neoadjuvant     chemotherapy setting varies and identifies the need for alternate functional imaging     strategies. Diffuse optical spectroscopic imaging is an experimental imaging method that     allows patients to be followed from baseline through treatment and surgery with a     cost-effective, bedside, handheld scanning probe. The researcher evaluates a harmonized     diffuse optical spectroscopic imaging technology platform that has been standardized for     neoadjuvant chemotherapy monitoring. Diffuse optical spectroscopic imaging is an academic     research platform that is non-invasive. Studies will be performed in five clinical sites on     approximately 60 neoadjuvant chemotherapy patients.   "
154821|NCT01257919|"     Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in     comparison to Azelaic Acid gel.      Assessment of safety after repeated skin application.   "
154822|NCT01257906|"     ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) gel, marketed by Medicis, The     Dermatology Company®, is a safe and effective topical therapy used for the treatment of acne     vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of clindamycin     phosphate (1.2%) and tretinoin (0.025%) topical gel and the current study is designed to     evaluate the bioequivalence of this formulation to ZIANA®.   "
154823|NCT01257893|"     The purpose of this study is to compare the rates of aspirin resistance (high residual     platelet reactivity) between women with episodic and chronic migraine and women without     migraine.      Emerging evidence suggests that migraineurs, especially women < 45 years who have aura, have     an increased risk of stroke and myocardial infarction (MI, or heart attack). The mechanism     linking migraine, stroke and MI is unclear although increased platelet activation and     aggregation observed during and between migraine attacks may be a plausible theory.      Aspirin is an inexpensive, relatively safe antiplatelet drug that reduces the risk of stroke     and MI. Preliminary data suggest that aspirin's (325mg) therapeutic effect on platelet     inhibition may be reduced in migraineurs (i.e., aspirin resistance), thus limiting aspirin's     effectiveness at preventing stroke and MI risks in persons with migraine. Additional research     is warranted to confirm these findings in migraineurs because daily, low-dose aspirin 81 mg     is the recommended first line therapy for primary and secondary prevention of stroke and MI      The researchers hypothesize that resistance to aspirin 81mg may occur more frequently in     women with episodic and chronic migraine than in women without migraine. The findings may     have important implications for women who have migraine and use aspirin to prevent migraine     symptoms or comorbidities associated with migraine including stroke and MI.   "
154841|NCT01257659|"     The primary objective of this study is to compare the function results between two methods     for surgically repairing rectoceles: vaginal versus endo-anal surgery. Our working hypothesis     is that the relatively new type of endo-anal surgery will result in better voiding function     compared to the traditional vaginal surgery.   "
155315|NCT01250925|"     The purpose of this study is to utilize in-vivo confocal microscopy to describe differences     in corneal epithelial immune status across three lens care regimens in new contact lens     wearers.   "
154832|NCT01257776|"     A prospective, multicenter, open, randomized, parallel-group controlled study for two levels     of dose.      The study population will consist of 30 non-diabetic patients with critical chronic ischemia     in at least one of the lower limbs (CLI) and without possibility of revascularization, from     whom results can clinically be evaluable, of whom, 20 patients will be included in the     experimental group (10 for each dose level) and 10 in the control group.      In each of the two dose levels to be used in the study, 15 patients will be included, who     will be randomized to the experimental group or the control group according to a distribution     2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level,     we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose     tissue) and 5 patients in the control group (conventional treatment)   "
154849|NCT01257555|"     The purpose of the study is to evaluate the safety and efficacy of a photopneumatic therapy     for the treatment of acne and concomitant symptoms associated with the disease, including     erythema.   "
162507|NCT00002353|"     To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered     subcutaneously in HIV-seropositive patients.   "
154824|NCT01257880|"     The purpose of the study is to compare the rate of comorbidities associated with migraine     aura (MA) between persons who have a large circulatory right-to-left shunt (RLS) and those     who do not have RLS.      Approximately 50% of individuals who have MA also have RLS due to patent foramen ovale (PFO).     A PFO is an anatomical opening or flap between the upper chambers of the heart or atria that     permits blood to pass from the right of the heart to the left side of the heart, without     first going to the lungs to be filtered and oxygenated. Many health conditions and clinical     syndromes including stroke, sleep apnea, and migraine have been linked to PFO. Although the     mechanism is undetermined, it is hypothesized that microscopic blood clots and chemicals such     as serotonin can pass through the PFO, travel to the brain, and cause headache and aura.      Persons who have MA are at increased risk for stroke and transient ischemic attacks relative     to people who do not have migraine. Migraine is also associated with the presence of white     matter lesions in the brain and mild deficits in cognitive function associated with the     posterior brain (vision, memory, processing speed). The risk of stroke in migraine is highest     for women under the age of 45 who have aura and a high number of migraine headache days per     month. No convincing evidence has been produced to explain the mechanism for the increased     risk of ischemic stroke in migraine; however, increased platelet activation and aggregation     is a plausible theory.      We hypothesize that migraineurs with aura and large RLS (presumably due to a PFO) will be     more likely to have sleep apnea, increased platelet activation, cognitive deficits,     alterations in cerebral vasomotor function, and white matter lesions than migraineurs with     aura who do not have PFO. The results of this exploratory study will generate hypotheses as     to why subgroups of migraineurs have an increased risk of stroke and the impact of large PFO     on comorbid conditions associated with migraine aura. Early identification of migraine     subgroups with a constellation of clinical syndromes that increase risk of neurovascular     diseases will allow initiation of preventive strategies that may ultimately reduce burden and     improve the productive quality of life for these individuals.   "
154825|NCT01257867|"     This study investigates the effects of daily use of lithia water on blood tests of neuronal     oxidative stress, mood, and well-being. Lithia water is a type of pure spring water     containing trace levels of lithium, which is a naturally occurring mineral. Neuronal     oxidative stress is caused by normal chemical reactions in the human body that sometimes     result in damage to brain cells. Participation in this study will last for 8 weeks and     includes daily use of study water for drinking.      The primary objective of this pilot study is to test the hypothesis that, in healthy male     participants, daily use of lithia water will improve neurogenesis and antioxidant capacity as     measured by serum levels of brain-derived neurotrophic factor (BDNF) and oxidative stress     markers. Secondary objectives will include examining self-reported changes in mood,     cognition, and well-being.   "
154826|NCT01257854|"     Test the correlations between the pharmacogenetic and pharmacokinetic of Busulfan IV in     children receiving hematopoietic stem cell transplantation.   "
154827|NCT01257841|"     The original study executed between 2002-2004 was an interventional trial in which 20,     healthy, normal-weight female subjects were randomized to a four-day fast plus daily     subcutaneous injections of leptin or a four day fast plus daily subcutaneous injections of a     placebo. The primary endpoints were gonadotropin pulsatility, TSH secretion and thyroid     function, and cortisol secretion. The current study is a secondary analysis focussed on the     placebo group which underwent a four-day fast. The study is looking at the effects of fasting     on gut-derived hormones and inflammatory markers in healthy, normal-weight women. The     hypothesis for this secondary analysis was that four days of fasting would augment levels of     orexigenic gut-derived hormones and suppress levels of anorexigenic gut-derived horomones,     while suppressing secretion of inflammatory cytokines.   "
154828|NCT01257828|"     CSM (Cervical spondylotic myelopathy) is the most common cause of spinal cord injury     worldwide. While there is evidence from the recently completed SpineNet prospective study     that surgical decompression is an effective treatment for CSM, it is clear that many patients     have remaining neurological impairment. While surgery is relatively safe, approximately 3% of     patients maintain a neurological problem. Given this background and data from preclinical     models of non-traumatic and traumatic spinal cord injury, there is strong evidence to     consider the potential benefit of adding a neuroprotective drug which aids in the treatment     of patients with CSM whom are undergoing surgical decompression. Riluzole is FDA-approved for     the treatment of amyotrophic lateral sclerosis, which has some similar clinical features to     CSM. Riluzole is currently under investigation for traumatic spinal cord injury. Given this     background, there is a strong basis to consider studying the potential neurological benefits     of Riluzole as a treatment to surgical decompression in patients with CSM.   "
154829|NCT01257815|"     This study evaluates a new investigational treatment regimen of three consecutive monthly     doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for     the first three months then two-monthly follow-up until 18 months in patients with visual     impairment due to diabetic macular oedema.The aim of the study is to determine if this     treatment regimen is effective and safe in these patients.   "
154830|NCT01257802|"     The purpose of this study it to determine whether the use of a gonadotropin releasing hormone     (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in women with     rheumatic diseases will provide greater ovarian protection than placebo.   "
154831|NCT01257789|"     Background: Laparoscopic Roux en Y gastric bypass (LRYGB) is associated with a significant     learning curve. We report the results of a systematic training programme from a high volume     bariatric center measuring the outcome by comparing the results with data from a consecutive     series of 1000 fast track LRYGB.      Method: Using a stepwise training programme the RY gastric bypass operation was divided into     an upper and lower procedure and subdivided into 11 well defined steps. A laparoscopic     surgeon without experience in upper GI surgery was mentored by an experienced bariatric     surgeon. During 6 months full time fellowship 300 operations were performed.      Results: The trainee surgeon performed 61 upper procedures, and 121 lower procedures in which     the mentor surgeon did the other part of the operation. In 110 patients the trainee performed     both procedures. Two percent had peri-operative complications compared to 1% of 1000     patients. All were repaired and had an uneventful recovery. Two percent had postoperative     complications < 30 days compared to 2.8% in the clinic. In the trainees series there were no     leaks compared to 1% in 1000 patients. Operative time was 56/55/70 min for operation     0-100/100-200/200-300 compared with an average of 47 minutes registered in the clinic.     Concerning time to discharge there was no difference between patients operated by the trainee     and the standard of the clinic.      Conclusion: Using a systematic training program in laparoscopic RY gastric bypass surgery     eliminates morbidity of the learning curve without affecting the volume.   "
154842|NCT01257646|"     The main objective of this study is the estimation and comparison of the dephasing between     the switch heel and the inertial placed on the paretic foot compared to the events of the     gait cycle determined by a Gaitrite system (beginning and end of the swing phase) in     conditions without stimulation.   "
170754|NCT00073281|"     This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with     stable renal allografts by islet transplantation.   "
154833|NCT01257763|"     The purpose of this study is to evaluate the safety and tolerability of an experimental     device that introduces microscopic channels into the skin. Creating microscopic channels in     the skin allows for better absorption of various medications applied to the skin, and this     study will determine if the study device offers a tolerable method by which to introduce     these holes. The study population will include 54 individuals, ages 18-74 years old, with a     roughly equal distribution of skin colors. Each subject will have a total of three visits 24     hours apart from one another. The study device will be applied at the Baseline and Day 1     visits. At various timepoints before and after device application, skin assessments for     irritation will be completed using a 7-point Skin Reaction Scale and photographs will be     taken. Subjects will report pain associated with device application using a standardized pain     scale. At the baseline visit, a member of the research staff will administer applications of     the study device on the side of the subject's forehead, temple and the area below and to the     side of the nose on randomly selected sides of the face. The side of the face at each     location not receiving application of the study device will receive applications of a dummy     device. Subjects will not be informed of which device is the study device and which is the     dummy device. At the Day 1 visit, a member of the research staff will administer study     device applications to the center of the subject's forehead. The subject will also self-apply     the study device to the chin, under the instruction of the research staff member. At the Day     2 visit, final skin assessments will be made and the subject will be evaluated and treated     for any persistent skin irritation. Differences in skin irritation between sites of study     device application and dummy device application will be determined, as well as several     other endpoints.   "
154834|NCT01257750|"     The purpose of this study is to determine the safety and efficacy of a drug [Pazopanib     (Votrient)] as a treatment for corneal neovascularization. The cornea is the clear, central     portion of the eye and neovascularization means blood vessel growth. The cornea is typically     avascular, or without blood vessels. Corneal neovascularization in the cornea and can put     vision at risk. Numerous diseases of the cornea such as inflammation, ischemia (restriction     of blood supply), infection, degeneration (or deterioration), trauma, or corneal stem cell     deficiency can lead to corneal neovascularization. This major ocular complication can lead to     corneal scarring, edema (swelling), lipid deposits, and inflammation that may significantly     alter your vision. In addition, it worsens the outcome of potential future treatments, such     as a corneal transplant. A corneal transplant is a treatment that many patients with severe     corneal disease may ultimately need.   "
154835|NCT01257737|"     The present protocol is a treatment protocol to allow continued use of HPN-100 for the     treatment of UCD subjects who complete 12 months of treatment in Study HPN-100-005,     (NCT00947544), HPN-100-007, (NCT00947297), or HPN-100-012, (NCT01347073). Under this     protocol, long-term safety will continue to be assessed.   "
154836|NCT01257724|"     The investigators have developed an online database called 'Synthesized HIV/AIDS Research     Evidence' (SHARE), which is designed to support the use of research evidence by those working     in the HIV/AIDS sector. This study will evaluate whether a full-serve version of SHARE     increases the use of research evidence by community-based organizations as compared to a     self-serve version. The full-serve version of SHARE consists of several components: 1) an     online searchable database of synthesized research evidence relevant to HIV/AIDS , 2)     periodic emailed updates, 3) access to user-friendly summaries and 4) peer-relevance     assessments. The self-serve version consists only of a listing of relevant synthesized     research evidence . The investigators will also interview participants in the study to obtain     feedback about SHARE, how helpful it was in their work, why it was helpful (or not helpful),     what aspects were most and least helpful and why, and recommendations for improving it.   "
154837|NCT01257711|"     Both Billroth II and Roux en Y are acceptable techniques of reconstruction after subtotal     gastrectomy, however the debate one which is better remains unanswered. The aim of this study     is to compare Billroth II and Roux en Y reconstruction techniques after radical distal     subtotal gastrectomy for gastric cancer in terms of postoperative outcomes and quality of     life. The investigators hypothesize that Roux en Y will have lesser gastrointestinal symptoms     and reflux problems when compared to Billroth II reconstruction. Patients with resectable     gastric cancer meeting the inclusion criteria will be consented and enrolled. Data on     demographics, nutrition, gastrointestinal symptoms, and quality of life will be collected.     They will be randomized after completion of distal subtotal gastrectomy to under go either     Roux en Y or Billroth II reconstruction. Surgery data will be collected post-operatively.      At 6 months follow up a repeat nutritional assessment using clinical and biochemical     parameters will be carried out. The biochemical markers are part of routine follow up. The     final assessment will be at the one year post surgery visit when by interview using EORTC 30     questionnaire quality of life data, gastrointestinal symptoms and nutritional assessment and     surgery data for recurrence will be repeated. At one year patients will also have upper     gastrointestinal endoscopy, which is part of routine follow up. At endoscopy stump gastritis     will be graded and esophageal reflux assessed as per Los Angeles classification. It is     postulated that 5% of the patients on Roux en Y reconstruction will experience poor clinical     symptoms compared to 25% of those on Billroth II based on reflux symptoms. To achieve a     statistical significance with 95% power and a 2-sided test of 5% for this 20% clinical     difference, 80 subjects for each arm will be required. Factoring a 10% attrition rate for     mortality and lost to follow up, a total of 160 subjects to be randomized equally will be     recruited.   "
154838|NCT01257698|"     The purpose of this study is to see if glaucoma eye drops (dorzolamide-timolol) have any     effect on the duration of an intraocular gas bubble following pars plana vitrectomy.   "
154839|NCT01257685|"     The pathogenesis of nonalcoholic fatty liver disease has not been fully elucidated. The most     widely supported theory implicates insulin resistance as the key mechanism leading to hepatic     steatosis, and perhaps also to steatohepatitis.      Selenoprotein P(SeP) is a secretory protein primarily produced by the liver. Previous studies     demonstrated that SeP, a liver-derived secretory protein, causes insulin resistance.      Therefore, the purpose of this study is to determine the different Sep levels between healthy     normal group and NAFLD group.   "
154840|NCT01257672|"     Vomiting in children with acute gastroenteritis is a major factor of failure of oral     rehydration therapy. Effective symptomatic treatment of vomiting would lead to an important     reduction in the use of Intravenous Fluid Therapy. Available evidence on symptomatic     treatment of vomiting shows the efficacy of the most recently registered molecule     (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice,     such as domperidone, is lacking.      The aim of this multicentre, double-blind randomized controlled trial is to compare the     efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children     with acute gastroenteritis who have failed Oral Rehydration Therapy.   "
168676|NCT00036361|"     The purpose of this study is to learn if aripiprazole is effective in the treatment of a     large number of persons diagnosed with schizophrenia or schizoaffective disorders   "
154844|NCT01257620|"     This exploratory study has been designed to determine the effect of the probiotic     Bifidobacterium infantis vs. placebo orally administered over a period of 3 weeks on clinical     features, Quality of Life parameters (QoL), intestinal permeability and inflammatory markers     of patients having positive serological evidences of Celiac Disease.   "
154845|NCT01257607|"     The objective of this study is to compare the safety and efficacy of 1% MIM-D3 and 5% MIM-D3     to placebo for the treatment of the signs and symptoms of dry eye.   "
154846|NCT01257594|"     The purpose of this study is to test the effectiveness of a drug called erlotinib in treating     the tumor. This is a multi-center pilot study that explores efficacy and molecular effects of     high dose weekly erlotinib for recurrent EGFR vIII mutant malignant gliomas, and correlate     molecular profile of pre-treatment tissue with outcome.   "
154851|NCT01257529|"     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a     pregabalin controlled release tablet following either a low, medium, or high-fat evening meal     as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the     safety and tolerability of a single dose of a pregabalin controlled release tablet following     a low, medium, or high fat evening meal as compared to a single dose of the pregabalin     immediate release capsule.   "
154852|NCT01257516|"     The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a     pregabalin controlled release tablet as compared to multiple doses of the pregabalin     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin     controlled release tablet as compared to multiple doses of pregabalin immediate release     capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin     controlled release tablet as compared to multiple doses of the pregabalin immediate release     capsule.   "
154853|NCT01257503|"     A randomized controlled trial of a commercially available homeopathic cold remedy will be     conducted. A total of 400 children, 2-5 years old, diagnosed with an upper respiratory tract     infection will be randomized to receive either the homeopathic remedy or placebo. Parents of     study children will administer 5 ml of the study medication up to 6 times per day as needed     to treat cold symptoms. One hour after giving a dose the parent will rate change in symptoms     (for up to the first 10 doses). In addition, parents will rate their child's overall symptom     severity and functional status over the first 3 days of the cold. It is postulated that     children receiving the active homeopathic remedy will have better symptom relief and that     their symptom severity and functional status will improve more rapidly than those receiving     placebo.   "
154854|NCT01257490|"     This study recruited cigarette smokers under supervision in community corrections (e.g.,     probation, parole, drug courts, etc.) in the Birmingham, Alabama area. Smokers received 12     weeks of bupropion treatment and brief physician advice to quit smoking or 12 weeks of     bupropion treatment and 4 sessions of intensive counseling around smoking cessation. The     study was stratified on race such that equal proportions of African Americans and Caucasians     were enrolled in the two study groups. It was hypothesized that smokers receiving intensive     counseling will have higher quit rates compared to smokers receiving brief advice to quit.   "
154855|NCT01257477|"     An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current     clinical practice setting.   "
154856|NCT01257464|"     The purpose of this study is to determine whether the dipeptidyl peptidase IV (DPPIV)     inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes     (CFRD). We hypothesize that sitagliptin will improve meal-stimulated insulin secretion.   "
154857|NCT01257451|"     This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly     patients with Type 2 Diabetes Mellitus (T2DM).   "
154858|NCT01257438|"     The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent     Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of     the Arteriovenous (AV) access circuit of hemodialysis patients with either of the two     predominant vascular access types - those with an AV graft and those with an AV fistula.   "
154859|NCT01257425|"     The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin     pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the     curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.   "
154860|NCT01257412|"     This study intends to compare the efficacy and safety of dapagliflozin versus placebo in     treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet     and exercise alone.   "
154861|NCT01257399|"     To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug,     marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool),     in patients with Ulcerative Colitis in remission, treated for 48 weeks.   "
154862|NCT01257386|"     To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug,     marketed Mesalazine, regarding the primary endpoint (reduction of UC-DAI score)in patients     with active ulcerative colitis (UC) treated for 8 weeks.   "
154863|NCT01257373|"     The goal of this study is to assess the long-term efficacy and safety of Firebird2     Cobalt-Chromium（CoCr）-alloyed sirolimus-eluting stent in treatment of complex lesions in     diabetes.   "
155393|NCT01249885|"     The purpose of this study is to examine pacifier sucking habits among children, and to assess     implications of the oral habit - for example malocclusions and drooling. The effect of     pacifier sucking will be recorded and compared to pacifier type and frequency of use.   "
154864|NCT01257360|"     The objective of this trial is to obtain evidence that, in patients with RAS wildtype tumors,     a chemotherapy-free combined modality treatment with panitumumab is clearly superior to     radiotherapy alone and achieves a pCR rate comparable to that after radiochemotherapy     including two-drug combinations while reducing the toxicity compared to these two-drug     regimens.   "
154865|NCT01257347|"     The purpose of this study is to test whether accurately measuring patients' adherence to     their blood pressure medications with electronic pillbox monitors and then providing     clinicians with this information can improve the clinical management of uncontrolled     hypertension.   "
154866|NCT01257334|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy     to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic     control.      Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled     patients (HbA1c > 10%)   "
154867|NCT01257321|"     Obstructive sleep apnea syndrome (OSAS) is the most common indication for tonsillectomy and     adenoidectomy in young children. According to previous studies, as much as 8 to 20% of     patients will develop post operative respiratory complications requiring medical     intervention. The pre-operative risk factors that could predict respiratory complications     retrospectively analyzed were young age, obesity and high preoperative apnea-hypopnea index.     Despite the removal of obstructing lymphoid tissue, upper airway obstruction occurs on the     first postoperative night in children with OSA. There is a debate regarding the     post-operative duration and monitoring needed in children with OSA.      Hypothesis:      Pre-operative, operative and immediate post-operative parameters could predict post     tonsillectomy respiratory complications.   "
154869|NCT01257295|"     Dietary fibers likely have a role in body weight management. They may increase satiety and,     as a consequence, reduce energy intake during the next meal. There are, however, many     different types of dietary fiber, which have diverse physical properties and can therefore     impact these outcomes differently. It is, however, unclear whether dietary fibers with     different properties lead to differences in energy intake during the next meal. The objective     of this study is to study the effect of pectin in 4 different physicochemical states on ad     libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones,     gastric emptying rate, feelings of satiety and the method of fiber supplementation. We     hypothesize that viscous and gelling fibers will reduce ad libitum energy intake compared to     low viscous and low gelling fibers.   "
154870|NCT01257282|"     This study includes patients with stable coronary artery disease without previously known     myocardial infarction, and investigates the prevalence of clinically unrecognized myocardial     damage and its prognostic implication.   "
154871|NCT01257269|"     Hereditary thrombotic thrombocytopenic purpura (Upshaw-Schulman syndrome) is a rare disorder     characterized by thrombocytopenia as a result of platelet consumption, microangiopathic     hemolytic anemia, occlusion of the microvasculature with von Willebrand     factor-platelet-thrombic and ischemic end organ damage. The underlying patho-mechanism is a     severe congenital ADAMTS13 (a disintegrin and metalloproteinase with thrombospondin type 1     motif, 13) deficiency which is the result of compound heterozygous or homozygous ADAMTS13     gene mutations.      Although considered a monogenic disorder the clinical presentation in Upshaw-Schulman     syndrome patients varies considerably without an apparent genotype-phenotype correlation. In     2006 we have initiated a registry for patients with Upshaw-Schulman syndrome and their family     members to identify possible triggers of acute bouts of TTP, to document individual clinical     courses and treatment requirements as well as possible side effects of long standing plasma     substitution, e.g. alloantibody formation or viral infections.   "
154872|NCT01257256|"     The current study attempted to explore the relationships among stressors (cognitions of     illness, socioeconomic status, social support, marital stressor, social stressor, etc),     perceived stress level, and emotional reactions (anxiety and depression) of infertile     patients and to propose the measurement and structural models of infertile aniexty and     depression.   "
154873|NCT01257243|"     The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine,     guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough     treatment.   "
154874|NCT01257230|"     The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses     of tiotropium bromide compared to placebo in adolescent patients with moderate persistent     asthma. Efficacy and safety will be assessed by measuring lung function parameters and     evaluating the effects on asthma exacerbations, on Quality of life, on health care resource     utilisation an on the number of adverse events.   "
154875|NCT01257217|"     The purpose of this study is to evaluate visual and refractive parameters in a series of     subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during     cataract surgery.   "
154876|NCT01257204|"     To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of     daclatasvir with pegylated interferon alfa-2a and ribavirin.   "
154877|NCT01257191|"     The goal of this study is to see how the type and size of particles found in air pollution     affects inflammation in the nose in people who are skin test positive to at least one     allergen. It has been observed that pollution makes allergies worse. It has also been     suggested that very small particles may affect allergies more than larger particles.   "
154878|NCT01257178|"     The purpose of this study is to evaluate the impact of hepatic dysfunction on the     pharmacokinetics and safety of LY2624803 and its major metabolite, LSN2797276.   "
154879|NCT01257165|"     Zopiclone, a widely used hypnotic drug, is frequently found in blood samples taken from     drivers suspected of driving under the influence. In this study, the investigators aim to     correlate zopiclone serum concentrations with degrees of driving impairment in healthy     volunteers by use of a validated driving simulator. The investigators also aim to compare     their results with the results from a previous study that investigated zopiclone impairment     of cognitive and psychometric tests.   "
155409|NCT01249677|"     Glucose-induced insulin secretion is often diminished in hyperglycaemic patients with type 2     diabetes. The investigators examined, whether chronic basal insulin treatment with insulin     glargine lead to improvements in glucose-induced insulin secretion.   "
154880|NCT01257152|"     A prospective, multicenter study:        -  Primary objective: to assess the diagnostic yield of screening MRI compared to physical          examination, mammography or ultrasonography in the detection of recurrence in patients          treated with breast conserving therapy        -  Secondary objective: to describe the size, type, grade, and nodal status of cancers seen          only on MRI and to estimate the rate of benign biopsies and short interval follow-up          induced only by MRI in this population.   "
154881|NCT01257139|"     This is a phase III randomized multicenter study involving subjects over 70 years of age with     non small-cell lung cancer of IV and a PS of 0, 1 or 2, who have not previously received     chemotherapy. The aim is to validate the use of a simplified geriatric scale (SGS) as a     screening tool. If the SGS results are normal, the patient will be treated with dual-agent     therapy based on platinum (carboplatin + pemetrexed if the histology is non epidermoid,     carboplatin + gemcitabin if the histology is epidermoid), with no further geriatric     assessment. When the SGS reveals abnormalities, a comprehensive geriatric evaluation (CGE)     will be used to define two subpopulations on Balducci's fragility scale, who will receive     either monotherapy (docetaxel) or best supportive care.      The strategy based on the SGS will be compared with a treatment algorithm based on standard     criteria (PS and age), with no specific geriatric assessment. The main endpoint is the time     to treatment failure. The SGS is composed of the Charlson co-morbidity scale, functional     assessment based on PS, Katz' ADL scale, Lawton's simplified IADL scale, simplified cognitive     assessment with the mini-MMSE according to Schultz-Larsen, a geriatric depression scale (GDS     5), and screening for a geriatric syndrome defined by the existence of dementia, repeated     falls, and urinary and fecal incontinence. The SGS will be validated by comparison with the     CGE, that will be administered systematically at enrollment. All the SGS items are included     in the CGE.      Secondary endpoints will be quality of life (measured with the LCSS and EuroQoL     questionnaires), overall survival, the objective response rate, and toxicity. The     investigators will also study the predictive power of nutritional indices such as the PINI     and the Buzby score with respect to survival, the treatment response, and tolerability.   "
154882|NCT01257126|"     This is a local, phase IV, open-label, randomized, head to head study of children aged 3 to 7     years. The objective of the study is to compare the efficacy of a single dose of both     diclofenac potassium and nimesulide in the reduction of fever and pain secondary to upper     respiratory tract infection.   "
154884|NCT01257100|"     Background:      - Nasopharyngeal carcinoma (NPC) a common malignant tumor in southern China and Southeast     Asia. Infection with Epstein-Barr virus is believed to be necessary for the development of     NPC; non-viral environmental factors, such as dietary consumption of nitrosamines, cigarette     smoking, betel nut chewing, wood dust exposure and possibly exposure to formaldehyde, have     been implicated in the disease. Genetic susceptibility may also play an important role in the     development of NPC. However, more information is needed on the connections between genetic     and environmental factors in NPC, particularly in areas where the cancer risk appears to be     greatest.      Objectives:      - To examine the main effects of genetic factors and environmental exposures (e.g., cigarette     smoking, betel nut chewing, formaldehyde, wood dust) on nasopharyngeal carcinoma risk.      Eligibility:        -  Cases: Individuals at least 21 years of age who have been diagnosed with NPC at one of          the participating hospitals and have been residents of northern Taiwan for at least 6          months.        -  Controls: Hospital patients with diseases other than NPC at least 21 years of age,          matched to NPC patients based on hospital, age at diagnosis, gender, and ethnicity.      Design:        -  This study involves a risk factor interview, medical record abstraction and biological          sample collection.        -  Participants will respond to interview questions about their lifestyle and risk factors          thought to be involved in NPC development.        -  All participants will provide blood and saliva samples for study. Participants who have          been diagnosed with NPC will also provide consent to allow researchers to study tissue          samples taken during tumor biopsies or surgeries.        -  Treatment will not be provided as part of this protocol.   "
154885|NCT01257087|"     Obesity surgery is very effective in improving or even curing Type 2 Diabetes in patients     with obesity. Many patients stop or reduce their medication after surgery and this can happen     fairly quickly. The investigators do not know whether strict control of blood glucose/sugar     after the operation makes any difference in the long term. Additionally many patients prefer     their blood sugars to be a bit high because they are afraid of hypos.A number of studies     have described patients whose eye, nerve and kidney disease has deteriorated when high sugars     are controlled very quickly. The investigators want to ensure that surgery provides maximum     benefit and remains safe in patients with diabetes. This study will help us decide if the     investigators should be strict with blood glucose after obesity surgery operations or not and     whether obesity surgery is safe for the eye, nerve and kidney complications of diabetes.   "
154886|NCT01257074|"     Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of     this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as     treatment for Herpes Labialis in comparison to acyclovir 50mg/g.   "
154887|NCT01257061|"     Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and     impaired quality of life due specially pruritus and physical visible skin lesions. The     propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g +     dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.   "
154888|NCT01257048|"     The main purpose of this study is to evaluate the sensitivity of a new oxygen enhanced     magnetic resonance imaging (OE-MRI) method in detecting changes in the lungs of patients with     moderate to severe chronic obstructive pulmonary disease (COPD) following treatment with     either Oxis Turbuhaler or Symbicort Turbuhaler.   "
154889|NCT01257035|"     The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of     response to neoadjuvant chemoradiation of locally advanced rectum cancer.   "
154900|NCT01256333|"     Despite improving in the treatment of acute respiratory distress syndrome (ARDS), this     affection keep an elevate rate of death. The strategy of mechanical ventilation is more and     more under definite protocol, following large strength randomized studies. Although, it     doesn't exist today element allowing to adjust the level of Positive End-Expiratory Pressure     (PEEP) with improvement in patient's survival.      The investigators proposed in this study to determinate the level of PEEP adjust to obtain     the better arterial oxygen transport (TaO2). The investigators going to conduct a     physiologic, observational, none controlled study. All patients hospitalized in intensive     care unit of Pontchaillou hospital with ARDS criteria and without specific exclusion criteria     will be included. Primary objective is to looking for the optimum level of PEEP for TaO2.   "
154890|NCT01257022|"     The main goal of the proposed study is to evaluate the efficacy of Familias Unidas (United     Families), a family-based, ecodevelopmental intervention found to be previously efficacious     in preventing and reducing behavior problems, illicit drug use, and unsafe sexual behavior in     non-delinquent Hispanic adolescents (Pantin et al., 2003; Prado, Pantin, Briones et al.,     2007).      The study hypotheses are as follows:      Hypothesis 1. Familias Unidas will be more efficacious than Treatment as Usual in preventing     drug use among Hispanic first offending adolescents or those who are at risk for committing a     first time offense over time.      Hypothesis 1a. The effect of Familias Unidas on drug use will be partially mediated by     improvements in family functioning.      Hypothesis 2. Familias Unidas will be more efficacious than Treatment as Usual in preventing     unsafe sexual behavior among Hispanic first offending adolescents or those who are at risk     for committing a first time offense over time.      Hypothesis 2a. The effect of Familias Unidas on unsafe sexual behavior will be partially     mediated by improvements in family functioning.      Hypothesis 3. Familias Unidas will be more efficacious than Treatment as Usual in preventing     subsequent criminal offenses among Hispanic first offending adolescents or in preventing a     first time offense for those at risk for committing a first time offense over time.      Hypothesis 3a. The effect of Familias Unidas on subsequent criminal offenses will be mediated     by family functioning.   "
154906|NCT01256255|"     The investigators purpose is to prospectively characterize influenza infections over a 3 year     period in transplant patients using a registry system. The investigators plan to generate     robust data on clinical features of upper and lower respiratory disease, antiviral therapy     and its effects on disease outcome, as well as quantitative virologic data on shedding and     antiviral resistance. The investigators also will study the long term sequelae of influenza     infections and look at development of rejection.   "
155079|NCT01254006|"     In this study the investigators are going to study the retinal nerve fibers layers (RNFL)     modification of two groups of patients, one taking no drugs, the other taking forskolin,     rutin and vitamins B1 and B2.   "
154891|NCT01257009|"     Hypertensive chronic kidney disease (CKD) patients often have sympathetic hyperactivity which     appears to contribute to the pathogenesis of hypertension and cardiovascular organ damage.     Experimental studies and some clinical studies have shown that statin therapy can reduce     central sympathetic activity. Blockade of the renin-angiotensin system (RAS), which is     standard treatment for CKD, is known to lower sympathetic activity.      The investigators hypothesize that adding a statin for 6 weeks to RAS blockade would further     lower sympathetic activity in hypertensive stage 2-4 CKD patients.      Methods: In ten stable CKD patients who are on chronic treatment with renin-angiotenis     blockers, blood pressure and sympathetic activity (quantified by assessment of muscle     sympathetic nerve activity, MSNA) will be assessed at baseline and 6 weeks after atorvastatin     20mg/day added.      Ten other CKD patients will serve as time control and will be studied twice with an interval     of 6 weeks without any change in medication, to quantify within subject reproducibility.   "
154892|NCT01256437|"     The investigators hypothesized that topical anti-inflammatory treatment could counteract the     inflammatory reaction induced by EGFR'Is.   "
154893|NCT01256424|"     An effective and safe medical therapy would be most welcome to reduce the need for surgical     interventions and related adverse events and psychological impact on patients with cervical     cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy     and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to     moderate-grade CIN (grade 1-2).   "
154894|NCT01256411|"     The purpose of this study is to assess the long-term safety, tolerability and efficacy of     LCZ696.   "
154895|NCT01256398|"     This phase II clinical trial studies how well dasatinib followed by stem cell transplant     works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by     stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may     interfere with the ability of cancer cells to grow and spread. Giving more than one drug     (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more     cancer cells.   "
154896|NCT01256385|"     This phase II trial studies how well giving temsirolimus together with cetuximab works     compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and     neck cancer who did not respond to previous therapy. Temsirolimus may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,     such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor     cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. It is not yet known whether giving temsirolimus together with cetuximab     is more effective than giving temsirolimus alone.   "
154897|NCT01256372|"     This study investigates the effect of two dose-levels of AP214 on the prevention of (acute)     kidney injury after cardiac surgery.   "
154898|NCT01256359|"     This is a randomised, double-blind placebo controlled phase 2 trial. Patient will be randomly     assigned 1:1 between 2 treatment arms. They will receive either docetaxel 75mg/m2 IV and     placebo given bd, or AZD6244 75mg bd daily with docetaxel 75mg/m2 IV. Docetaxel will be     administered every 3 weeks for a maximum 6 cycles, but AZD6244/placebo may be continued     beyond this, until disease progression. The objective is to assess whether the combination of     AZD6244 with docetaxel is worthy of evaluation in a definitive randomised study, with the     null hypothesis being that the combination has activity similar to that of docetaxel alone in     this population. After consent has been obtained mutational analysis of tumour BRAF will be     performed on archival tumour tissue, where this information is not already known, to assess     eligibility for the study. If there is no archival tissue a fresh biopsy will be requested     from the patient. A blood sample will also be taken for future genetic analysis. Once taking     part in the trial patients will need to attend their oncology unit regularly for monitoring     and the delivery of treatment. Patients will undergo complete physical examination at     screening, on C1D1, C1D8, C1D15, C2D1, C2D8 and day 1 of every subsequent cycle. Blood for     haematology, biochemistry and clotting will be taken at each of these visits. A 12 lead ECG     will be performed at screening . Disease assessment will be by CT scanning using modified     RECIST criteria after 9 and 18 weeks, then every 3 months until disease progression.   "
154899|NCT01256346|"     The goal of this study is to compare the time required for accurate heart rate measurement of     the preterm newborn when using pulse oximetry versus electrocardiography leads.   "
154901|NCT01256320|"     The current research study has the potential to generate data that would provide solid     clinical endpoints as to the impact of including eggs in a regular diet in individuals with     peripheral arterial disease. Any one of three potential outcomes may be observed as a result     of this study, and they are predicted as follows: 1) Egg consumption does not lead to a     deterioration of indices of cardiovascular health; 2) Egg consumption improves indices of     cardiovascular health; 3) Egg consumption worsens the indices of cardiovascular health.   "
154902|NCT01256307|"     There are two types of treatments depending on the severity of Obstructive Sleep     Apnea/Hypopnea Syndrome (OSAS): - for the treatment of severe (AHI> 30/h), the standard     treatment is Continuous Positive Airway Pressure (CPAP). If it proved effective in reducing     excessive daytime sleepiness and associated cardiovascular risk, compliance of patients 4     years of treatment falls below 70%. - Treatment of moderate (AHI between 15 and 30/h),     lifestyle measures, the bracing of mandibular advancement and / or possibly the head and neck     surgery can be proposed. These treatments include side effects and their effectiveness is     very controversial.Il therefore seemed interesting to test the impact of physical activity     through a standardized training program to re personal effort on the development and     improvement of OSAS patients with a sedentary moderate to severe OSAS (AHI between 15 and 40     / h) The main assumption is that the ESR could eventually delay the initiation of treatment     with CPAP in severe OSAS or an alternative therapeutic relevance in the moderate OSAS and     severe in patients who can not tolerate conventional treatment(CSF). The main objective of     this biomedical research is to evaluate the effects of a program of REE in ambulatory index     of hourly apneas / hypopneas (AHI = marker of severity of OSAS) .- objectives specify 2AIR     effects of REE on the quality of sleep (TxSLP) and daytime symptoms (EDS objective fatigue)     on the one hand and the other on the metabolism (OV, SM, IR) and markers of LCR     (inflammation, oxidative stress , endothelial function).   "
154907|NCT01256242|"     Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary     surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment     Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator     cuff tendon and the humeral head providing further enhanced tendon to bone healing without     adding any additional safety risk to the patient.      Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical     intervention of a torn rotator cuff and to obtain preliminary data to support the rationale     for a subsequent pivotal clinical trial.   "
154908|NCT01256229|"     Children with special needs require complex, individualized therapy to maximize their     long-term quality of life. One subset of children with special needs includes those with both     developmental delays and deafness. Currently, there is little compelling evidence supporting     the idea that cochlear implantation provides benefit to children that don't have the     cognitive potential to develop normal speech and language.      We will perform a prospective, randomized clinical trial to answer the question of which     intervention provides more benefit to this population of children using validated,     norm-referenced tests.      Our long-term goal is to develop guidelines that may help when selecting a treatment for     hearing loss in a child with developmental delays.      This proposal is significant because children with special needs are deserving of evidence     upon which to base treatment decision-making, but remain under-represented in the medical     literature and are often not studied. This research is designed to meet the criteria for the     National Institutes of Health road map because it will generate this type of objective     evidence that can directly improve patient care.   "
154909|NCT01256216|"     The purpose of the data collection is to document the performance and clinical outcomes of     the Vanguard Knee using Signature Custom Cutting Guides and Computer Assisted Surgery.   "
154910|NCT01256203|"     Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a     non heated laser. The activation of the drug is done by illuminating abnormal areas using a     fiber optic device. The fiber optic device is a very fine fiber (like fishing line) that     permits transmission of light. By itself, porfimer sodium is inactive. However it becomes     active when it is put in the presence of a light source such as sunlight, very intense indoor     light, or laser. Therefore, the main risk with this therapy is that the skin will be more     sensitive to light, and this sensibility can last up to 90 days. The skin reaction is similar     to sunburn and is called phototoxicity.      To date, no product on the market has shown protection against visible light, and therefore,     no product has been demonstrated to protect against the skin phototoxicity to visible light.     A sunscreen sold under the brand name Solar Protection Formula® SPF 60 in the United States     contains ingredients that provide maximum ultraviolet (UV) protection, as well as a     formulation that could provide visible light protection. The product could potentially     prevent the skin phototoxicity due to visible light, the most frequently reported side effect     in patients receiving PDT with porfimer sodium. Therefore, this study is designed to assess     the efficacy of topical application of Solar Protection Formula® SPF 60 as skin protector     against visible light-induced skin redness and swelling following injection of porfimer     sodium. It will involve 17 to 20 human subjects in the United States for whom PDT with     porfimer sodium is planned for the treatment of high-grade dysplasia in Barrett's esophagus     (pre-cancerous change in the food pipe tissue), lung cancer, or cancer of the esophagus (food     pipe).   "
154911|NCT01256190|"     A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and     safety trial in subjects undergoing open liver resection surgery. The study will enroll 42     eligible subjects and be conducted at 4 sites in the Netherlands.   "
154912|NCT01256177|"     The primary objective of this study is to evaluate the superior efficacy of quetiapine     extended release(XR) mono-therapy, administered once daily compared to placebo, in the     treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder   "
154918|NCT01256099|"     This study includes two sub-trials.      In trial 1 patients suffering from insomnia but not meeting the criteria for depression are     randomised to either therapist guided Internet-based CBT for insomnia or to a control group     with a non-guided, brief self-help program that acts as a placebo control. The primary     purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment     and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the     costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive     effect on future depressive episodes. Recruitment is done through mass media and includes all     regions of Sweden. Initial assessment based on questionnaires and telephone interviews.      Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done     between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each     respective treatment's effect on both insomnia and depression. The patients need for further     treatment after the initial one will be measured and used as a secondary outcome. Recruitment     is done through mass media but only citizens in the Stockholm area are included since the     initial assessment are based on both questionnaires and telephone interviews as well as a     visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm.      Both trials will include health economic data and analysis. For the longer follow-up periods     (1 and 3 years), registers will be used to analyse consumption of sleep medication and     antidepressants as well as general health care utilization.   "
154919|NCT01256086|"     The purpose of this study is to estimate the relative potency for bronchoprotective effect of     formoterol Novolizer 12 µg (test) compared to formoterol Aerolizer 12 µg (reference).   "
154920|NCT01256073|"     The trial is a multi-centre, open-label, safety and tolerability extension trial to the     IPH2101-101 (previously NN1975-1733) first human dose trial completed with a larger subject     pool at an optimal dose level. The trial is conducted in elderly Acute Myeloid Leukemia (AML)     patients over the age of 60 years, in complete remission, and who are not eligible for     allogeneic stem-cell transplantation. The dose given to the individual patient will be the     same as the patient received in the single dose trial IPH2101-101 and 1 mg/kg or 2 mg/kg for     the 12 patients in an additional cohort.   "
154947|NCT01255722|"     The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol     (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide     (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability     (quality and interpretability of images).   "
154921|NCT01256060|"     Extensive data has been accumulated to suggest that central release of oxytocin is important     for social cognition and function, as well as likely involved in anxiety modulation and     repetitive behaviors. The principal investigators of this study have previously documented:     1) an association between Autism Spectrum Disorder and a single nuclear polymorphism of the     oxytocin receptor gene, 2) ability to measure oxytocin levels in the blood by enzyme     immunoassay and 3) preliminary data to support safety and efficacy of intranasal oxytocin in     the treatment of social deficits and repetitive behaviors in adults with autism. A medication     treatment targeting the core deficits of Autism Spectrum Disorder in childhood is highly     valuable because it could influence the developmental trajectory and make further     psychosocial interventions possible. In this context, we propose a small dose finding study     to confirm that the dose used in the adult study is not more than the maximum tolerated dose     in youth. `   "
154922|NCT01256047|"     The purpose of this study is to determine whether preoperative immunonutrition is effective     on infectious complication and Th1/Th2 differentiation in patients with major hepatectomy.   "
154923|NCT01256034|"     The purpose of this study is to determine whether preoperative immunonutrition is effective     on infectious complication and Th1/Th2 differentiation in patients with     pancreaticoduodenectomy.   "
154924|NCT01256021|"     The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the     treatment of children with cerebral palsy.   "
154925|NCT01256008|"     The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on     depression and anxiety in breast cancer patients.   "
154926|NCT01255995|"     -  The purpose of this study is to determine the natural course of IOL in PXF,        -  To demonstrate use of a clinical grading system for PXF,        -  To strategize a way to prevent IOL dislocation, subluxation post operatively,        -  To demonstrate intraoperative and long-term post-operative complications associated with          phaco and PXF        -  To suggest evidence-based ways to minimize these complications, by using capsular          tension rings (CTR), specific IOL material or size   "
154927|NCT01255982|"     This study aims to study prospectively for 8 months a sample of bipolar patients with acute     depressive episode in order to identify that factors associated with functional impairment,     with especial attention to the presence of subsyndromal symptoms beyond the acute phase.   "
154928|NCT01255969|"     To evaluate if a model of intervention based on a low-grade physical program prescribed in     the dialysis centre and performed at home can modify the functional capacity and quality of     life, reduce the risk of cardiovascular and all-causes mortality, non-fatal cardiovascular     events and vascular access failure in dialysis patients.   "
154929|NCT01255956|"     The aim of the study is to compare rapamycin eluting stent and paclitaxel eluting balloon     catheter in the treatment of restenosis in bare metal stent.   "
154930|NCT01255943|"     The purpose of this study is to implement strategies for improved efficiency and waste     reduction (Toyota Lean) and positive deviance, a social behavioral change process,     utilizing frontline healthcare personnel to reduce infection bloodstream infection and MRSA     infection in outpatient dialysis care. In two outpatient dialysis units, dialysis unit     healthcare staff will be educated in Toyota lean techniques and conduct periodic discovery     and action dialogues to identify and implement care process changes to reduce infection.     Outcomes to be monitored will include incidence of bloodstream infections and MRSA infections     of all types. Data will be assessed at quarterly intervals using interrupted time series     analysis.   "
154931|NCT01255930|"     The aim of this study is to evaluate placenta maturity by the sonographic textures.The     evaluation of placenta maturity by the sonographic textures is related to anticipative     pregnancy and actual pregnancy . By analyzing this theory, the investigators want to bring up     another objective and accurate analysis method in order to provide information for the     evaluation of clinical trials.   "
155000|NCT01255033|"     The purpose of this study is to compare the ability of two peripheral and non invasive     devices to detect hypoxic events during one-lung ventilation and during the early     postoperative period. One device measures regional cerebral oxygenation and the other     muscular oxygenation. These two devices are compared to non invasive arterial saturation     (SpO2), which is the gold standard.   "
154932|NCT01255917|"     This study is to understand the role of nerve growth factor(NGF) and other cytokines in the     pancreatic fluid of patients with chronic pancreatitis.      Hypothesis:        1. Pain does not correlate with changes in the PD morphology suggesting that pain in CP is          not only a mechanical problem        2. Pain in CP correlates better with the levels of NGF in the pancreatic juice. NGF is          variably expressed in different morphological stages of CP and regulates the sensitivity          of the peptidergic nociceptors and is upregulated in pancreatic inflammation.   "
154933|NCT01255904|"     The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal     dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).   "
154934|NCT01255891|"     To evaluate the efficacy of LHRH agonist with adjuvant pelvic radiation therapy in post     radical prostatectomy patients with high risk pathological features for failure. To determine     the freedom from biochemical (maintenance of a PSA less than nadir + 2 ng/ml) and clinical     progression rate at 5 years.   "
154948|NCT01255709|"     This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine     Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (MDI) (E004), using a     stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the     administered drug from the endogenous epinephrine, in healthy male and female adult     volunteers.   "
154949|NCT01255696|"     A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.   "
154950|NCT01255683|"     Despite the common use of oral steroids in the management of chronic rhinosinusitis (CRS),     the natural history and efficacy of this treatment modality has not been fully elucidated.     Specifically, patients who have undergone prior ESS and have recalcitrant CRS, the natural     history of endoscopic improvement and quality of life (QoL) outcomes, following an oral     steroid taper, is poorly defined. The purpose of this non-randomized single-arm clinical     trial is to evaluate the effectiveness of an oral steroid taper in improving endoscopic     grading, QoL, and olfactory function as well as defining the duration of improvement, in     patients with recalcitrant CRS with prior endoscopic sinus surgery (ESS).   "
154935|NCT01255878|"     Sleep bruxism (SB) is defined as a stereotyped movement disorder characterized by grinding     or clenching of the teeth during sleep usually associated with sleep arousal. It might lead     to abrasive tooth wear, hypermobility of teeth, tooth hypersensitivity, hypertrophy of the     masticatory muscles and pain in the masticatory muscles.      Diagnostic procedures include clinical evaluation, ambulatory monitoring sleep laboratory     investigations and others. The clinical approach comprises the patient's history, orofacial     examination, and tooth wear classification.      There is no specific treatment for bruxism. Management of SB comprises psychological,     orodental and pharmacological strategies.Orodental therapies, including soft vinyl mouth     guards or stabilization bite splints, probably function more like protectors of the orofacial     structures rather than actually diminishing bruxism.Drug treatment of sleep bruxism is     controversial since different treatment strategies have resulted in suppression or     exacerbation of this condition.      Based on the current data, central primary efferents are the major drivers of bruxism.     Therefore centrally acting agents such as antiepileptic drugs which also affect the sleep     structure, might be effective on SB.      In a case report of bruxism, anxiety and tremor, the authors suggested that anti-convulsant     Gabapentine may be a useful treatment for patients with antidepressant-induced bruxism.     However in the absence of definitive evidence, the appropiate treatment of SB is still a     matter of debate.      The objective of the present study was to compare the treatment efficacy of occlusal     stabilization splint and Gabapentine on SB, using polysomnographically determined outcome     measures for the quantification of sleep bruxism.   "
154936|NCT01255865|"     The purpose of this trial is the generation of clinical data required for a 510(k) submission     to the FDA. The trial design reflects elements desired by the FDA. The trial is designed to     satisfy the relevant requirements of the FDA Guidance (March 1993) on the content of     premarket notification [510(k)] submissions for clinical electronic thermometers and ISO/IEC     80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements for basic safety     and essential performance of clinical thermometers for body temperature measurement.   "
154937|NCT01255852|"     Severe intracranial atherosclerosis with concomitant stenosis is responsible for     approximately 10% of all strokes. Retrospective studies have indicated that up to 50% of     patients with a recently symptomatic intracranial stenosis experience recurrent ischemic     events. Due to the high stroke risk, patients with high grade 70% symptomatic intracranial     stenosis represent the main target group for endovascular treatment. Atorvastatin is widely     used in the treatment of hyperlipidemia, especially after acute myocardial infarction.     High-dose atorvastatin has been known to stop the progression of atherosclerosis and to     decrease the levels of inflammatory markers. Several recent clinical trials have proved     atorvastatin can reduce restenosis after stent implantation in coronary artery. But the     feasibility of atorvastatin in preventing restenosis in patients with intracranial stenting     has not been evaluated.The purpose of this prospective, randomized, single-blinded trial is     to evaluate the effect of atorvastatin 80 mg daily in preventing restenosis and related     vascular events in patients with intracranial stent implantation.   "
154938|NCT01255839|"     The use of prostaglandin E2 (PGE2) for induction of labour in women with unfavourable     cervices is well-established1. There are, however, potential side effects to prostaglandins,     in particular the risk of uterine hypertonicity which may affect fetal outcome. In theory a     mechanical ripening based on dilatation of the cervix as well as induction of production of     endogenous prostaglandin has potentially less influence on the fetal outcome but a Cochrane     review from 2001 scrutinized studies on mechanical ripening versus placebo/no treatment or     prostaglandin E2. They conclude there is insufficient data to evaluate the effectiveness in     terms of likelihood of vaginal delivery in 24 hours, and emphasise the need for large sample     size studies and substantive outcomes. Two later randomised studies compared mechanical     ripening to PGE2 and found discrepant results regarding time from induction to delivery.      The primary purpose of the present study was in a randomized design to compare the efficacy     of double-balloon catheter versus vaginal PGE2 (minprostin 3 mg) on induction of labour,     duration of birth and fetal outcome. Secondary analyses were to evaluate the results for     various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm     birth and intra uterine growth restriction.   "
154940|NCT01255813|"     The purpose of the proposed clinical study is to evaluate the use of an implanted     Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of     the pain associated with cluster headaches.   "
154941|NCT01255800|"     This study will evaluate the clinical activity of the combination of ipilimumab (IPI) -926 in     combination with cetuximab in patients with advanced head and neck cancer.   "
154942|NCT01255787|"     The purpose of this study is to assess the efficacy and safety of multiple doses of     vortioxetine, once daily (QD), in participants with major depressive disorder.   "
155001|NCT01255020|"     The prospective, double blind randomized, parallel control, and multi-center clinical trial     will evaluate the safety and efficacy of α-keto acid with restricted protein diet on     protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD)     patients.   "
154943|NCT01255774|"     The rationale for evaluating LucentisTM (a recombinant humanized anti-human Vascular     Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular (wet)     Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF levels     in aqueous and vitreous humor and active blood vessel formation. LucentisTM has been shown to     maintain or improve vision in wet AMD. Since the treatments do not halt the loss of visual     acuity in wet AMD, it is important to accurately measure anatomic response to treatments     thereby enhancing the ability to understand patterns of response and predict the necessity     for continued therapy.   "
154944|NCT01255761|"     Phase 4 study to evaluate a routine patient completed assessment (RAPID3) compared to a     physician completed assessment (CDAI) to predict treatment success with subjects with     moderate to severe rheumatoid arthritis   "
154945|NCT01255748|"     The purpose of this research study is to collect and analyze information from patients being     treated with various forms of radiation therapy.   "
154946|NCT01255735|"     The primary objective of this study is to determine the impact of voice therapy on     voice-related quality of life in children age 6-10 years old with apparent vocal fold     nodules, as measured by the validated Pediatric Voice-Related Quality of Life Instrument     (PVRQOL)administered 4 weeks after completion of voice therapy.   "
154951|NCT01255670|"     Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are     required in addition to abscess drainage we perform a prospective, double blind,     placebo-controlled, randomised study on 200 adult patients with peritonsillar abscess. 100     patients are given penicillin and metronidazole and 100 patients get penicillin and placebo.     Recovery and recurrence and analyzed.   "
154952|NCT01255657|"     This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and     evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.   "
154953|NCT01255644|"     Chronic lymphocytic leukemia (CLL) is increasingly believed to be closely related to chronic     stimulation of healthy B-cells. Identification of antigen(s) are relevant for the stimulation     of CLL precursor cells is therefore of high interest. The investigators found recently     evidence that a herpes virus is involved in this process of stimulation. Consequently,     elimination of the antigenic stimulation of leukemic cells by this herpes virus may be     expected to reduce or even inhibit propagation of leukemic cells. The investigators     hypothesize that inhibition of CMV replication by a short course of antiviral treatment may     reduce significantly proliferation rates of leukemic cells. To test this hypothesis, the     investigators will treat 20 CLL patients with an antiviral drug for 3 months in a     proof-of-concept clinical trial and leukemic cell counts measured before and after antiviral     treatment. Antiviral treatment has the potential to treat the disease at its origin and     therefore more efficiently than conventional chemotherapeutic regimens.   "
154954|NCT01255631|"     The most important prognostic indicator for the breast cancer patient is the axillary lymph     node status. With the introduction of the sentinel lymph node biopsy, many women were spared     the morbidity of a full axillary lymph node dissection(ALND) while having the axillary nodes     assessed with a low false negative rate. Approximately 30% of women who undergo ALND     experience shoulder/arm morbidity including numbness, pain, weakness and decreased range of     motion. In addition, the sentinel lymph node dissection (SLND) held the promise that women     with early stage breast cancer would be able to avoid the dreaded morbidity associated with     axillary lymph node dissections including lymphedema, decreased range of motion and pain.     Since the adoption of SLN, numerous papers have documented that SLN is superior to ALND.     However, patients who undergo SLN still have a significant amount of pain with this     procedure. There are few published studies which objectively assess the subjective and     objective symptoms of SLND.      Pulsed electromagnetic fields (PEMF) have been shown to be effective in the treatment of     fractures and spinal fusion, relief of pain in acute sprains and whiplash injuries,     improvement of skin blood flow, healing of venous stasis ulcers, and reduction of     postmastectomy lymphedema. Indeed, radiofrequency PEMF devices are FDA approved for pain and     edema relief. PEMF devices are economical and disposable, and can be incorporated     unobtrusively in standard post-op dressings. We have recently reported, in a double-blind,     placebo-controlled study on breast reduction, that post-op PEMF therapy produced a     significant decrease in pain and pain medication use, along with a concomitant decrease in     IL1-beta in the wound bed.1 The current pilot study will be designed to determine if PEMF     treatment, given in addition to standard of care, can reduce post-operative discomfort and     morbidity after lumpectomy and SLND, or lumpectomy and ALND. Lumpectomy and ALND/SLND     patients enrolled in the double-blind, placebo-controlled study will undergo standard     surgery, but will be randomized to one of two groups: the treatment group with a PEMF coil     placed around the arm and the control group with a coil that delivers no PMF. We expect     postoperative pain to be reduced in the PEMF-treated patients as well as improved arm     mobility and strength. The use of PEMF might reduce the need for narcotic pain medications     and their side effects of sedation, nausea, and vomiting. It may also reduce costs related to     arm morbidity.   "
154955|NCT01255618|"     Near infrared spectrophotometry (NIRS) offers the possibility of noninvasive and continuous     bedside investigation of cerebral , renal, mesenteric and peripheric oxygenation and     hemodynamics, and changes in newborn period.The aim of the present study is to investigate     cerebral oxygenation with NIRS method in polycythaemic infants who underwent partial exchange     transfusion.   "
154956|NCT01255605|"     The purpose of this is to determine the impact of intermittent preventive treatment (IPT)     with sulfadoxine-pyrimethamine (SP) on the morbidities associated with malaria in pregnant     women and newborns in rural peri-urban areas of Bobo-Dioulasso, 5 years after its     implemented.   "
154957|NCT01255592|"     The purpose of this study is to investigate the effect of AZD5069 in patients with     bronchiectasis.   "
154958|NCT01255579|"     New formulations of extrafine particles of long acting beta-2 agonists+inhaled     corticosteroids (LABA+ICS) are able to reach more peripheral regions of the lung.      Objectives.The aim of this study was to assess the effect on small airways obstruction of     long-term treatments with two different LABA+ICS combinations in asthma.      Patients and methods.Ten subjects with moderate persistent asthma were enrolled. After a     4-week washout they were treated in a randomized cross-over design for 24 weeks with     formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d. (FB) or salmeterol 50 mcg and     fluticasone 250 mcg (diskus) b.i.d. (SF). At baseline and at the end of each period subjects     underwent Asthma Control Test (ACT) and Pulmonary Function Testing. The N2 phase III slope     and closing volume (CV) during single breath washout test, and DElta(Heliox-air)MEF50% were     measured to assess changes on peripheral airways function.   "
154959|NCT01255566|"     This investigation is a prospective, multi-institutional cohort study comparing the     differences in health-related quality-of-life (HRQoL) improvements between subjects electing     continued medical management for chronic rhinosinusitis and those electing medical management     plus surgical intervention.      Our hypothesis is 3 fold: 1. That patients electing continued medical management will have     less disease severity as measured by CT and baseline HRQoL scores, 2. Patients undergoing     medical management plus ESS for chronic rhinosinusitis will experience a larger improvement     in health related quality of life (HRQoL)compared to patients electing medical management     alone, and 3. Patients undergoing medical management plus ESS for chronic rhinosinusitis will     use fewer antibiotics, systemic steroids, and miss fewer days of work/school compared to     patients electing medical management alone.   "
154960|NCT01255553|"     This is a pilot study to determine if partial breast irradiation (PBI) limited to the region     of the tumor bed following lumpectomy in patients screened with MRI provides historically     similar rates of local failure, limited acute skin toxicity, late complications and cosmetic     outcome when compared to patients treated with standard 3D-CRT to the whole breast.   "
154961|NCT01255540|"     The rationale of the present clinical trial is to study whether an invasive strategy in     clinical stable patients over 80 years with NSTEMI/UAP may improve rates of death,     reinfarction, stroke, need of urgent revascularisation, myocardial function and quality of     life. The invasive approach involves coronary angiography with immediate evaluation for three     different treatment options; 1. Percutaneous coronary intervention (PCI), 2. Coronary artery     bypass graft (CABG) or 3. medical treatment. Clinical practice shows that older patients are     commonly treated less vigorously than younger patients and the present guidelines are based     on a considerably younger population.   "
154962|NCT01255527|"     Despite the advantages of autologous stem cell transplantation (ASCT) over conventional     chemotherapy,1,2 the results of high-dose chemoradiotherapy in multiple myeloma (MM) are     still unsatisfactory with a 6-year event free survival (EFS) of only 24%.      Based on existing data, bortezomib-containing regimens are currently accepted at many centers     as an induction treatment option for patients with symptomatic MM, particularly if it is     planned to offer subsequent high-dose therapy with ASCT. So we will use bortezomib-containing     regimens as induction prior to this novel conditioning regimen. The objective of the present     study is to compare the toxicity and therapeutic efficacy of a new high-dose regimen using     dose-escalation of BOR, BU and MEL for ASCT in the Korean patients with MM. The patients     should be treated with bortezomib-containing regimens as an induction therapy before ASCT. We     will specifically analyze (i) the efficacy of the conditioning regimen in improving the     pre-ASCT status, response rate (ii) engraftment and transplant-related mortality (TRM) and     (iii) the impact on survival including progression-free survival (PFS) and overall survival     (OS).      Triple combination of conditioning will enhance the response rate after ASCT, and will     improve not only PFS, but also OS. We think that data from this study may further strengthen     feasibility of BOR in conditioning prior to ASCT.   "
154963|NCT01255514|"     Complete Response (CR) plus near CR rate of VAD (Vincristine, Adriamycin, Dexamethasone)     induction chemotherapy followed by ASCT in patients with newly diagnosed MM was about 50% and     CR plus near CR rate of PAD (Bortezomib, Adriamycin, Dexamethasone) induction chemotherapy     followed by ASCT in patients with newly diagnosed MM was about 60%. If the CR with near CR     rate of sequential high-dose dexamethasone and response adopted PAD or VAD induction     chemotherapy followed by ASCT is more than 60%, this combination will be accepted as active     regimen that may be worth for investigating in phase III trial. But, if the CR with near CR     rate of this regimen is lower than 50%, this has not a merit than VAD induction chemotherapy.      Based upon the above assumption, this trial was designed by using Simon's optimal two-stage     testing procedure. Assuming a target level of interest, p1=0.6, and a lower activity level,     p0=0.5. Initially 61 patients will be accrued. If 33 or more CR + near CR rate were observed,     the trial will be continued. Accrual will be planned to a total of 190 patients. If total 106     or more patients were assessed as CR with near CR, sequential high-dose dexamethasone and     response adopted PAD or VAD induction chemotherapy regimen will be accepted as active     regimen. This design provides probability 0.05 of accepting drugs worse than p0 and     probability 0.20 of rejecting drugs better than p1. If we assume that drop-out rate is 10%,     total accrual patient will be 210.      Patient characteristics and toxicity will be evaluated by descriptive methods. Progression     free survival and overall survival (median value, 95% confidence interval) will be calculated     by Kaplan-Meier method.   "
154964|NCT01255501|"     The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic     profiles of a novel therapeutic drug when administered to healthy volunteers.   "
154965|NCT01255488|"     To better understand the extent to which family nurse practitioners (FNPs) might use research     abstracts in shaping their clinical decision-making under simulated conditions. A secondary     point is to examine if and how FNPs might use full-text manuscripts (associated with the     abstracts) if made available to them.   "
154966|NCT01255475|"     Previous studies have demonstrated a direct association between blood pressure level and     cardiovascular risk. However in patients with heart failure this association is considered     controversial. The aim of this study is to evaluate the effect of the reduction of blood     pressure in patients with heart failure. The investigators will examine the effects of this     intervention over mortality, quality of life, and cardiac function.   "
154967|NCT01255462|"     This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal     LFG316 in patients with advanced age-related macular degeneration.   "
154968|NCT01255449|"     The aim of the present study will be to test the hypothesis that changes in within-breath     total respiratory input impedance (Zrs) may provide an early evidence of obliterative     bronchiolitis after allogeneic hematopoietic stem cell transplantation (HSCT). Before and     after HSCT, Zrs will be measured by a modified forced oscillation technique (FOT) during     spontaneous breathing both at baseline and 30 min after albuterol inhalation . Such technique     may be particularly sensitive to small changes in lung mechanics observed in the early stages     of peripheral airflow obstruction.   "
154969|NCT01255436|"     Objective: To test the primary hypothesis that SMS text messages delivered to patients via     mobile phone can improve blood pressure within 12 weeks compared to usual care      Design: Parallel group, randomized, controlled trial; the patient is the unit of     randomization      Setting: General Medicine Outpatient Continuity Clinic of the Philippine General Hospital and     Private Outpatient Clinics near the Philippine General Hospital      Patients: Ambulatory men and women aged 19 years and older (N=700) with a diagnosis of     essential hypertension, on maintenance blood pressure-lowering medications, who have daily     access to a mobile phone in the household and know or live with someone who knows how to     retrieve, read and reply to text messages using a mobile phone      Intervention: SMS text messages delivered twice a week for 12 weeks, which aim to 1) provide     information regarding hypertension; 2) remind patients to take their medications.      Main Outcome Measure: The primary outcomes are the mean change in systolic and diastolic     blood pressures at the end of 12 weeks. The secondary outcomes are improvement in blood     pressure control rate and medication adherence.   "
154970|NCT01255423|"     The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1%     compared with placebo applied four times a day in subjects with acute ankle sprains under     'in-use' conditions, in particular with regard to pain relief.   "
154971|NCT01255410|"     People who are infected with human metapneumovirus (HMPV) may develop upper and lower     respiratory illnesses. Children are particularly sensitive to HMPV infection. This study will     evaluate the safety and immune response of an HMPV vaccine in healthy adults,     HMPV-seropositive children, and HMPV-seronegative infants and children.   "
155087|NCT01253902|"     This study evaluated the ocular surface tolerability of the prostaglandin analogues     bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004%     (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously     treated with Xalatan® who have open-angle glaucoma or ocular hypertension.   "
194887|NCT00399022|"     Testing the efficacy of the SNRI medication Duloxetine for treating OCD patients who did not     respond to SSRI   "
154972|NCT01255397|"     The purpose of this experiment is to test the feasibility of a minimally interventionist     protocol for young couples with male factor infertility, which addresses the cause of     infertility for these couples which is the inability of the sperm to fertilize the     egg.Ultrasound monitoring of natural follicular development utilizing rFSH, GnRH antagonist     and rHCG only for the final maturation. Single follicle aspiration and IUI or IVF/ICSI based     on sperm charcteristics on the day of fertilization. Fertilized eggs transfered to the uterus     on the same day as the aspiration.   "
154973|NCT01255384|"     Pregestational diabetes (PGD) during pregnancy may be associated with an increased rate of     spontaneous abortions, intrauterine death and congenital anomalies among the offspring.     Although the prevalence of congenital anomalies among the offspring of diabetic mothers is     reduced as a result of the improvement of the glycemic control in the early pregnancy, the     rate of congenital anomalies is increased and there seems to be an increased rate of     neurodevelopmental disorders including some fine and gross motor deficits as well as     increased rate of inattention and/or hyperactivity. In gestational diabetes, that develops in     the second half of pregnancy (past the period of major organogenesis), there seems to be no     increase in the rate of major congenital anomalies but there are some developmental disorders     in the offspring.      The exposure of the developing embryo and fetus to diabetic environment (i.e. hyperglycemia,     hyperketonemia ext), is known to cause increased oxidative stress and significant changes in     gene expression as observed in several experimental diabetic models. We hypothesize that     diabetic environment may also cause long lasting epigenetic changes. It is therefore our     purpose to evaluate these possible epigenetic changes and correlate their presence with the     degree and time of onset of diabetes, (i.e. whether from the beginning as in PGD or in the     second half of pregnancy as in GD), the degree of oxidative stress and with the     neurodevelopmental outcome of the offspring. Diabetic pregnancies will be compared to a     similar number of normal pregnancies in all parameters studied.   "
154974|NCT01255371|"     In the well recognized context of HIV infection chronicity, it is now crucial to identify and     evaluate effective, well tolerated and affordable second line regimen in resources limited     countries where patients often change treatment after a long period of viral replication     while on first line regimen.      This multicentre international, randomized, non-blinded phase III trial aim to demonstrate     the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily     intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily     intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level     (between 1000 and 5000 copies/mL versus > 5000 copies/mL) at inclusion, this trial will also     allow to evaluate the optimum moment for instituting the second-line treatment.   "
154975|NCT01255358|"     Multi-centre, single arm, open label, 6 months, phase II study to evaluate the effect of     Ery-Dex in improving Central Nervous System (CNS) symptoms in patients with Ataxia     Teleangiectasia (AT). The study consists of a screening period (max duration of 30 days) and     a treatment period (duration 6 months).   "
154976|NCT01255345|"     The purpose of this study is to investigate the frequency and severity of chronic pelvic pain     (CPP) in adult women living in Copenhagen Country and Zealand Country (total population 2,4     million), Denmark, in relation to selected factors, such as basic demographic and clinical     factors, health related quality of life, physical activity and abnormal muscular findings in     the pelvic area.   "
154977|NCT01255332|"     We designed a study for evaluate the efficacy of Helicobacter pylori eradication for the 1st     line treatment of immune thrombocytopenic purpura (ITP) patients with moderate     thrombocytopenia.      If this eradication treatment is revealed effective on ITP patients with more than 30X109/L     of platelet, it would be valuable treatment especially for young ITP patients with mild to     moderate thrombocytopenia.   "
154978|NCT01255319|"     To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide,     fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell     transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS).   "
154979|NCT01255306|"     The aim of the study is to evaluate the influence of silicone oil on thickness of the retinal     nerve fiber layer by using optical coherence tomography (OCT) in patients following pars     plana vitrectomy.   "
154981|NCT01255280|"     The purpose of this study is to research a new behavioral treatment to reduce sexual     risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal     meth), and are at risk for HIV acquisition. This study proposes using a treatment based on     our original pilot study that incorporates risk reduction and behavioral activation therapy.     In order to help learn what types of treatment programs best help individuals who abuse     crystal meth and engage in sexual risk-taking, we will compare our treatment to a control     group. The treatment group will receive therapy incorporating behavioral risk reduction     counseling with behavioral activation therapy to treat depression, helping individuals     reengage in their life. The control group will receive the risk reduction counseling without     the behavioral activation therapy. The current study hopes to explore the efficacy of this     previous developed treatment in a two-arm pilot randomized controlled trial.   "
154982|NCT01255267|"     In this study, we evaluate the acute coronary syndrome patients to see if there is     correlation between platelet activity, genetic polymorphism (CYP2C19 and ABCB1), serum     adipokines level, and Clopidogrel responsiveness.   "
154983|NCT01255254|"     The aim of the study is to evaluate the effect of non-surgical periodontal therapy,     consisting of oral hygiene instruction, full mouth scaling and an antimicrobial rinse on the     metabolic control of chronic periodontitis patients with type II diabetes mellitus.   "
155028|NCT01254669|"     In the United States, Black women are more likely to die of cervical cancer than White women.     In developing countries and globally, Haitian immigrant women are more likely to die of     cervical cancer than any other women in the world. Studies have shown a disparity in parental     acceptance of the HPV vaccine with parents of Black adolescent girls being less likely to     accept and comply with HPV immunization schedules than Whites. The objective of this study is     to increase HPV immunization rates in Haitian and African American adolescent girls. The     investigator's hypothesis is that a validated behavior change mechanism, brief-negotiating     interviewing (BNI), will effectively increase the proportion of mothers who give consent for     their daughters' HPV vaccine, which will ultimately lead to higher vaccination rates, and     increase knowledge of HPV infection and the vaccine in Haitian immigrant and African American     mothers.   "
154984|NCT01255241|"     Lower Limb Deformities (LLDF) is a rather common infirmity among children. LLDF may result     from various conditions such as trauma, tumors, infection, and dysplasia, congenital and     metabolic abnormalities. It is assumed that correction of deformities by surgical procedure     will improve ambulation and reduce energy expenditure.      This prospective study will document the process of establishing the initial localization and     magnitude of deformity through physical and radiological examination, kinetic and kinematical     parameters, and measuring energy expenditure. The study will also document the type of     surgical intervention undertaken to correct the deformity. Following a recovery from surgery,     children's ambulation will be assessed again, by physical and radiological examination, by     kinetic and kinematical parameters, and by measuring energy expenditure. A third series of     exams will be performed four months later.      It is expected that the surgical intervention will improve ambulation and reduce energy     expenditure. This study aims at establishing a model enabling to assess ambulation and energy     expenditure before and after surgical intervention. The results of the study may have     practical implications on the decision and type of surgical procedures.   "
154985|NCT01255228|"     Excessive body weight and obesity have reached epidemic proportions over the last few     decades, which may cause many chronic diseases. Maintaining a healthy life style could     decrease the risk for obesity, metabolic syndrome and cardiovascular disease. The study aimed     to evaluate long-term low glycemic index (GI) diet intervention on lipid profile, body     composition and the mechanism of obese women. The pilot study will recruit twenty healthy     subjects, and served test food to determine low GI food. In the experiment period, twenty     women age from 20-50 years will be recruited. To be included in the study, subjects should     have a BMI above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline > 80 cm). Before     dietary intervention, participants will receive food choice table and dietary questionnaires     to record their dietary intake.      The study will be a randomized, crossover, controlled clinical trails. The experiment period     have six weeks, each participants will provide low GI diet (lunch and dinner). On the 0, 3, 6     week, subjects will measurement their body composition (body weight, body mass, waist and hip     circumferences) and collect fasting blood samples to analysis the lipid profile, free fatty     acid, blood sugar, insulin, adiponectin, leptin and fatty acid synthesis enzymes. Statistical     analysis will be performed by paired t-test. The study expect that long-term low GI diet     intervention have beneficial effects on regulate body composition of obese women.   "
154986|NCT01255215|"     Despite the use of highly effective anti-malarial medications, 10-30% of African children     with severe malaria will die, underscoring the need for adjunctive therapies that can be     applied in endemic areas. A clinical trial of adjunctive inhaled nitric oxide (iNO) in severe     malaria is warranted on the basis of firm proof of concept from animal studies and a human     study using the NO donor L-arginine, together with evidence of safety from clinical     experience and trials of iNO for other conditions. Our objective is to determine whether     supplemental iNO (80 ppm) in addition to Ugandan Standard of Care treatment reduces levels of     Angiopoietin-2 (Ang-2), a quantitative biomarker of malaria severity, in children with severe     malaria compared to Standard of Care treatment alone. We will conduct a randomized     placebo-controlled trial among children 1-10 years of age admitted to Jinja Hospital (Uganda)     with severe malaria to test the efficacy of inhaled nitric oxide in severe malaria.   "
154987|NCT01255202|"     The purpose of this study is to finout whetere uterinae artery flow , PP13 and endogolin     levels in the serum and kongo red in the urine can predict preeclamsia toxemia in twin     pregnancies.   "
154988|NCT01255189|"     Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside     investigation of cerebral oxygenation in newborn infants. Using this technique we     investigated the effect of positional changes on cerebral oxygenation in preterm infants.   "
154989|NCT01255176|"     It gave a clinical trial which will be included in the 60 infants, aged up to 24 months,     diagnosed with congenital's population will be divided by simple randomization into three     groups: 20 infants in the intervention group, 20 infants in the control group, not receive     the RTA technique and another 20 infants in a placebo group, we just get the support manual     therapist for 5 minutes. Initially the data will be collected cardio heart rate, respiratory     rate and oxygen saturation. Then the researcher will apply three specific rating scales,     based on clinical presentation and behavior of infants. Hypothesis: The RTA improves     cardiorespiratory parameters and reduces signs of discomfort and pain of infants with     congenital heart acyanogenic.   "
155016|NCT01254825|"     The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to     placebo when it comes to analgetic efficacy after Knee-Arthroscopy.   "
155120|NCT01253473|"     The main objective of the study is to see if using anti-inflammatory to patients with airway     disease chronic obstructive pulmonary disease (COPD) phenotype will be more effective than     using these treatments in patients with loss of lung tissue. Symbicort plus     ipratropium/albuterol will be used for 12 weeks in an open-label study in subjects with     airway predominant COPD.   "
154990|NCT01255163|"     Background:      - Exendin-4 (or Exenatide) is a medication currently used to treat diabetes, but it has shown     promising results in tests of its effectiveness in protecting neurons from damaging processes     associated with Alzheimer s disease. It is possible that Exendin-4 may be a treatment for     Alzheimer s disease, which involves the gradual deterioration and death of neurons.     Researchers are interested in studying the safety and comparing the effects of Exendin-4 with     placebo to on congestive performance, overall clinical progression, various chemicals     measured in blood and cerebrospinal fluid, and brain MRI, in individuals with early-stage     Alzheimer's disease or mild cognitive impairment.      Objectives:      - To determine the safety and tolerability, as well as to acquire preliminary evidence for     the effectiveness of twice daily administration of Exendin-4 as a treatment for early-stage     Alzheimer s disease or mild cognitive impairment.      Eligibility:      - Individuals at least 60 years of age who have objective evidence of early-stage Alzheimer's     disease or mild cognitive impairment in screening testing.      Design:        -  Participants will be screened.        -  Following the telephone screening, two in-person screening visits to determine          eligibility.        -  The screening visit will involve a medical history and neurological examination, tests          of memory and cognition, a lumbar puncture, collection of blood and saliva samples, and          brain Magnetic Resonance Imagine (MRI) studies. Participants will be required to appoint          a Durable Power of Attorney for research and medical care during this protocol.        -  Eligible participants will be divided into two groups. One group will receive Exendin-4,          and the other will receive a placebo. Participants will keep a medication diary and will          be scheduled for additional study visits 1 and 2 weeks after the start of the treatment.        -  Participants will have regular followup visits with blood tests, imaging studies, and          other examinations 6, 12, and18 months after the start of the treatment. Another lumbar          puncture may be performed optionally at the 18-month followup visit.   "
155029|NCT01254656|"     This is a study to assess long-term safety and efficacy of lersivirine in patients who have     completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.   "
154991|NCT01255150|"     Background:      - Research has shown that the Epidermal Growth Factor Receptor (EGFR) gene is an important     target for personalized lung cancer treatment. Individuals who have mutations in the EGFR     gene have better responses when treated with certain personalized or targeted therapies     compared with conventional chemotherapy. These mutations are more frequent in females with     lung cancer who have never smoked, and different ethnic groups have different levels of     frequency of the mutations. Researchers are interested in collecting more information on EGFR     genetic mutations in Hispanics/Latinos with lung cancer, comparing the frequency of these     mutations in males and females and smokers and nonsmokers. This study may lead to better,     more personalized care approaches for all individuals with lung cancer.      Objectives:      - To study the frequency of Epidermal Growth Factor Receptor mutations in Hispanic/Latino     individuals who have been diagnosed with non-small cell lung cancer.      Eligibility:      - Hispanic or Latino individuals who have been diagnosed with non-small cell lung cancer and     who have lung tissue from a previous biopsy or surgery available for research purposes.      Design:        -  Participants will provide consent for researchers to examine lung tissue collected from          a previous biopsy or surgery.        -  Treatment will not be provided as part of this protocol....   "
154992|NCT01255137|"     Background:      - Adrenocortical carcinoma is an aggressive cancer that starts in the adrenal gland at the     top of the kidneys. It has a low survival rate if standard treatment options are not     effective. Axitinib is an experimental drug that is being studied to determine if it can stop     tumors from growing or make them smaller. Researchers are interested in investigating     axitinib in individuals with aggressive or otherwise untreatable adrenocortical cancer.      Objectives:      - To evaluate the effectiveness of axitinib in individuals who have adrenocortical cancer     that is inoperable and has not responded to standard treatments.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with adrenocortical cancer     that has not responded to standard treatments.      Design:        -  Participants will be screened with a full physical examination and medical history, as          well as tumor imaging studies.        -  Participants may have a tumor biopsy prior to starting axitinib.        -  All participants will receive axitinib to take twice a day with food for 28 days (1          cycle). Participants should not drink grapefruit juice or smoke cigarettes while          participating in this study.        -  After the first cycle, the dose may be increased and additional cycles will be given if          the treatment has not had serious side effects.        -  Participants will have regular examinations while taking axitinib, including blood          samples and tumor imaging studies to determine if the tumor has stopped growing. Blood          pressure levels will be carefully monitored during treatment to evaluate potential risk          for high blood pressure.        -  Participants may have a second tumor biopsy 20 to 30 days after treatment begins.        -  Treatment will continue as directed by the study researchers.   "
154993|NCT01255124|"     Hand, Foot and Mouth Disease（HFMD）is an infectious disease in infants and young children     caused by enterovirus. There was a great outbreak of HFMD in China, 2008, which brought not     only panic to the people, but also huge economic loss. Since 2008, HFMD has become one of the     category c infectious diseases in China. Studies showed that Human Enterovirus 71 (EV71) and     coxsackievirus A 16 (CVA16) are the most common reasons for this disease. And the     investigators are going to develop the vaccines for this disease. There is an urgent need to     know the dynamic changes of the maternal anti-EV71 and ant-CVA16 level in infants and young     children. In April 2007, the investigators started a clinical trial named 'The Safety and     Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates'     (ClinicalTrials.gov ID: NCT01183611). In that study the investigators already built a cohort     of Health Neonates, followed them and obtained the blood serum on the day 0, 30, 210 and 360     after born. So, based on the cohort and blood serum the investigators got, the investigators     plan this study to retrospectively investigate their HFMD histories from birth and follow-up     for another year to get the information about the incidence of HFMD. The investigators also     plan to assay the maternal anti-EV71 and anti-CVA16 antibodies on the day0 and the dynamic     changes of antibodies on 1st month, 7th month (day 210), 1st year (day 360) and on October,     2010.   "
154994|NCT01255111|"     BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability     and efficacy of this treatment during sleep in patients with chronic respiratory failure.      AIM: To study the variability of patient-ventilator interactions during the first nights     after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the     non-linear dynamics theory.      PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and indicated     to home NIV will be included. All patients will perform three polysomnographies (under     spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All     ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen     saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep     Laboratory of the Department and secondarily related to sleep architecture and quality of     sleep.      EXPECTED RESULTS: This study will identify objective parameters that are associated to a     satisfactory adaptation to nocturnal NIV.   "
154995|NCT01255098|"     This plan is to develop blood culture or to measure diagnostics of Immuno Magnetic Reduction     assay in the first stage.   "
155030|NCT01254643|"     This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese     girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable     immune response to all human papillomavirus (HPV) strains contained in the vaccine. The     success criterion for the primary analysis requires that point estimates for seroconversion     rate be greater than 90% for all 9 HPV types.   "
155031|NCT01254630|"     This is a randomized, double-blind, placebo-controlled study to assess the safety and     tolerability of V212 when administered to adults with solid tumor malignancy (STM) or     hematologic malignancy (HM) and to determine whether V212 reduces the incidence of herpes     zoster (HZ) in adults with STM or HM, as compared to placebo.   "
155088|NCT01253889|"     The purpose of this study is to compare the effect of a 25% glucose solution given via a     soother with or without facilitated tucking with a similarly administered water placebo     (control condition) on infant stress responses during and immediately after a neonatologist     performed ECHO (np-ECHO).   "
155724|NCT01245556|"     The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in     combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when     administered in combination with ipilimumab.   "
155002|NCT01255007|"     1. Primovist-enhanced Magnetic resonance imaging (MRI) and Diffusion Weighted MRI (DW-MRI)          is superior to Multidetector Computed axial Tomography (MDCT) in the detection of          colorectal liver metastases. Fatty changes in the liver after chemotherapy treatment          likely reduces the chances of seeing metastatic lesions on CT especially when the          lesions are small (<10 mm). When compared with CT, Primovist-enhanced MRI and DW-MRI          have the potential to provide higher contrast resolution enabling better detection of          colorectal liver metastases following chemotherapy.        2. Primovist-enhanced MRI and DW-MRI are superior to CT in assessing and predicting          treatment response of patients with colorectal liver metastases to chemotherapy.          Primovist-enhanced MRI by providing superior resolution may provide improved accuracy in          metastatic lesion margin detection thereby providing higher accuracy in estimating tumor          response based on size criteria. DW-MRI provides information indirectly about tumor          composition and therefore is likely to be superior to MD-CT in assessing treatment          response.      Two groups of patients will be analyzed. The second group consists of patients with     colorectal liver metastases who are to go for chemotherapy prior to surgery for metastases     resection. This group will be CT and MRI scanned prior to chemotherapy and after     chemotherapy. The first group of patients will consist of those patients who have already     received chemotherapy and are likely to have surgery to resect liver metastases. This group     will have only one set of scans done 4-6 weeks prior to their operation. The pathology of the     resected metastases and CT and MRI images will be analyzed and compared.   "
155003|NCT01254994|"     To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients     with acute on chronic hepatitis B liver failure (ACHBLF). A total of 108 patients with ACHBLF     were allocated into either a treatment group (ETV group, n=53) or a control group (n=55). The     HBV DNA level, liver function and survival condition of the patients were observed for 48     weeks after enrollment. The factors possibly related to entecavir treatment efficacy were     also identified.   "
155004|NCT01254981|"     To perform a randomized comparison between the Cypher Select+ stent and the Nobori stent in     the treatment of unselected patients with ischaemic heart disease.   "
155005|NCT01254968|"     The aim of the study is evaluation of cerebral blood flow (based on testing the rate of flow     in middle cerebral arteries by transcranial Doppler ultrasound) during different forms of     walking training - walk forwards and backwards, with closed and open eyes.   "
155006|NCT01254955|"     Organ transplant patients and staff members at the Transplant Institute have received     pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by     haemagglutination inhibition according to the clinical guidelines and policy, respectively.     This study retrospectively assessed the immune response after vaccination.   "
155007|NCT01254942|"     This is a parallel Randomized Controlled Trial comparing two different delivery modes of post     hip fracture management—a specialized Fracture Follow-up Clinic versus Usual Care alone. The     Fracture Follow-up Clinic will focus on bone health and fall risk factors. The investigators     will evaluate the effect of the clinic and exercise program on mobility and falls. The     investigators primary hypothesis is that within the first year following a hip fracture,     older adults who are assessed in the B4 Clinic and prescribed an exercise program will have     significantly improved Short Physical Performance Battery (SPPB) scores compared with     participants who receive usual care alone.   "
155008|NCT01254929|"     The purpose of this study is to compare 18F-Fluoride PET bone scans to traditional 99mTc-MDP     bone scan to determine if one is better for diagnosing bone metastases.   "
155009|NCT01254916|"     Introduction: Chronic rhinosinusitis (CRS) is a significant health problem increasing in both     incidence and prevalence. It calls into attention consensus about diagnosing, assessing     symptoms and treatment of patients with CRS. Therefore a validated Danish measure of     health-related quality of life in sinonasal disease is needed.      Method: The Sinonasal Outcome measure 22 (SNOT-22) was translated into Danish and     reproducibility was evaluated by test-retesting 40 patients with CRS. The statistical     analyses used, were Pearson´s correlation coefficient, Cronbach´s alfa, Kappa and     Bland-Altman´s Plot. Reproducibility was also tested looking at subscales within the SNOT-22.      Result: The results show good internal correlation with Cronbach´s alfa at 0.83 in the     initial test and 0.92 in the retest. Pearson was 0.70 (p<0.001) revealing good correlation     between the initial scores and the retests scores. Kappa was calculated for each item with a     mean value of 0.61 showing substantial agreement. Paired t-test revealed no significant     difference in the subscales.      Conclusion: The Danish version of SNOT-22 is recommended for Danish clinicians and researches     as a patient-reported measure of outcome in sino-nasal disorders such as rhinosinusitis and     nasal polyposis.   "
155010|NCT01254903|"     The goal of this clinical study is to learn the feasibility of using a single session of     radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural     spinal cord compression.   "
155011|NCT01254890|"     The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can     control the disease in patients with AML or MDS. The safety of this drug combination will     also be studied.   "
155012|NCT01254877|"     The proposed randomized clinical trial will investigate a novel pharmacotherapy for hazardous     drinking, HIV-infected men and women, using the 5-HT3 antagonist ondansetron. The     investigators predict that participants who are treated with active doses of ondansetron will     reduce their drinking more and show better HIV treatment participation and progress compared     to participants who are treated with placebo. This study will provide important new safety     and efficacy results on drinking and HIV outcomes following alcohol pharmacotherapy in     HIV-infected persons.   "
155013|NCT01254864|"     Objectives:      Primary Objectives:      To compare two two-stage treatment strategies for patients with castrate resistant prostate     cancer that has progressed after treatment with Abiraterone Acetate.   "
155014|NCT01254851|"     This study is a non-blinded randomized controlled trial. Consenting participants will be     randomized to routine post-operative ambulation vs. goal-augmented post-operative care (they     will be given a goal number of steps to take on each post-operative day) following in-patient     gynecologic surgery.   "
155015|NCT01254838|"     The purpose of this study is to evaluate the safety and CTL reaction of novel peptide     vaccination for advanced renal cell carcinoma   "
155017|NCT01254812|"     TAP-block (Transverse Abdominal Plane) block is a method of regional anesthesia used after     abdominal surgery. The method is often applied ultra-sound guided.      In our department, the so-called bilateral dual TAP-block (BD-TAP-block) has been developed.     This includes injection of local anesthetics at four sites on the abdominal wall, aiming at     the best possible spread of the nerve block.      Clinical experience shows satisfying results on pain relieve using the nerve block, i.e the     sensory nerves of the abdominal wall are successfully blocked. However, to our knowledge,     clinical investigations regarding the effect on the muscles of the abdominal wall has never     been executed.      Patients with chronic lung diseases, who are prone to catch pneumonia post surgery, may have     to be able to use accessory muscle groups to prevent pulmonary phlegm stagnation. Therefore     it would be inappropriate if the motor nerves supplying these muscles were too, affected by     the nerve block.      Our clinical experience has so far not given us suspicion or indication that the motor nerves     become blocked, although these nerves are situated in the same muscle layer as the sensory     branches.      Hence the investigators would like to examine on healthy, male subjects, whether application     of a bilateral-dual TAP-block effects their ability to perform peak-flow and inspiratory and     expiratory pressure. Our study hypothesis is:      There is no clinically relevant difference in the spread of results of pulmonary tests (peak     flow et.c.) before and after application of bilateral dual TAP-block.   "
155018|NCT01254799|"     This study aims to test the effect of Doxycycline in treatment of uterine bleeding during the     use of injectable contraception that contains one hormone progesterone only.   "
155019|NCT01254786|"     Video-assisted thoracoscopic surgery (VATS) is usually performed using well-collapsed lung is     essential for optimum surgical visualization and resection. However, one lung ventilation     (OLV) is associated with deleterious impaired oxygenation secondary to the increases in shunt     fraction.1 There are different approaches for the recruitment of the non-dependent lung (NL)     during OLV such as the selective application of continuous positive pressure ventilation     (CPAP) or high frequency positive pressure ventilation (HFPPV) to the non-dependent lung.2-4     These strategies may improve arterial oxygenation and reduce shunt fraction,2-4 However, the     use of high CPAP levels impaired the surgical conditions during thoracotomy.2-3 On contrary,     the application of HFPPV either to both lungs5or to the non-dependent lung permits adequate     surgical conditions during thoracotomy.4 The investigators hypothesize that the application     of volume-controlled HFPPV to the non-dependent lung during OLV for video-assisted     thoracoscopic surgery may provide better surgical field and adequate oxygenation than the use     of CPAP 2 cm H2O.      The investigators will evaluate the effects of the selective application of conventional one     lung ventilation, HFPPV, or CPAP 2 cm H2O to the non-dependent lung on surgical field     conditions, and arterial oxygen and carbon dioxide tensions (PaO2 and PaCO2, respectively)     during OLV in the patients scheduled for video-assisted thoracoscopic surgery.   "
155020|NCT01254773|"     This study in individuals with mild to moderate Alzheimer's Disease is designed to assess:(1)     safety and tolerability (2) the capacity of subcutaneous bapineuzumab to reduce brain amyloid     load as measured by positron emission tomography (PET) scans.   "
155021|NCT01254760|"     The purpose of this trial is to evaluate and compare the clinical performance of two     multifocal contact lenses.   "
155022|NCT01254747|"     The purpose of this 4-week dispensing trial is to evaluate and compare an investigational     soft contact lens worn on a daily disposable basis with three other soft contact lenses also     worn on a daily disposable basis.   "
155023|NCT01254734|"     RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and     neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical     trial studies how transoral robotic surgery works in treating patients with benign or stage     I-IV head and neck cancer.   "
155024|NCT01254721|"     The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy     compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation     of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using     the last observation carried forward method.   "
155025|NCT01254708|"     Lung transplant recipients have the highest rate of Invasive Aspergillus (IA)infection among     solid organ transplant recipients. The most important risk factor for the development of IA     (which is associated with disease and death) is colonization of the organism in the     respiratory tract.      Azoles are used to prevent the development of IA. Puffers containing antifungal medication     can be used to treat the lungs without the need to worry about the medication interactions &     side-effects in the blood. An example of this is the aerosolized amphotericin B. Its use is     limited by the patients' tolerating this medication that may cause cough, nausea &     contraction of the air pathways.      The lipid preparation is better tolerated and has longer dosing interval than inhaled     amphotericin B. The investigators propose a pilot study to determine the long-term safety of     inhaled AmBisome administration of drug and generate the preliminary data on the     effectiveness of this drug to prevent aspergillus colonization.   "
155026|NCT01254695|"     Faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population.     The magnitude of the problem is probably underestimated. Sacral nerve stimulation (SNS), has     over the last decade given hope to patient failing conservative treatment. Some patient do     not have optimal continence after SNS-therapy. This study aims to identify optimal     stimulation parameters - that will improve the functional outcome of SNS-therapy thru a     double blinded randomized cross-over study.   "
155027|NCT01254682|"     The primary objective of this study is to evaluate the efficacy and safety of Ostenil     application (1% hyaluronan) after arthroscopy of the wrist.   "
155058|NCT01254279|"     The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial     (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic     Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or     after docetaxel and to document the overall safety of cabazitaxel in these patients.      Please note that in each country, patient recruitment will end when cabazitaxel becomes     commercially available.   "
155121|NCT01253460|"     The goal of this clinical research study is to learn if sapacitabine given in combination     with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The     safety of this drug combination will also be studied.   "
155032|NCT01254617|"     This phase I trial studies the side effects and the best dose of lenalidomide when given     together with cetuximab in treating patients with colorectal cancer or head and neck cancer     that has spread to other places in the body and usually cannot be cured or controlled with     treatment. Biological therapies, such as lenalidomide, use substances made from living     organisms that may stimulate the immune system in different ways and stop tumor cells from     growing. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways     by targeting certain cells. Giving lenalidomide together with cetuximab may be a better     treatment for colorectal cancer or head and neck cancer.   "
155033|NCT01254604|"     This study will test the hypothesis that preservative-free tafluprost (MK-2452) is     non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular     pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle     glaucoma or ocular hypertension.   "
155034|NCT01254591|"     RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography     (PET/CT) scanning before surgery, may help measure the extent of disease.      PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with     non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and     neck cancer.   "
155035|NCT01254578|"     This phase I clinical trial is studying the side effects and the best dose of lenalidomide     after donor bone marrow transplant in treating patients with high-risk hematologic cancer.     Biological therapies, such as lenalidomide, may stimulate the immune system in different ways     and stop cancer cells from growing.   "
155036|NCT01254565|"     The purpose of this study is to characterize the safety and tolerability and efficacy of     multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of     secondary hyperparathyroidism (HPT).   "
155037|NCT01254552|"     This study is aimed to answer the clinical question of the prevalence of myocardial scar in     asymptomatic patients with type 2 Diabetes Mellitus with a special focus on the diagnostic     efficacy of Xenetix® 350-enhanced 64-rows MDCT for the visualisation of the coronary arterial     tree and secondarily for the assessment of myocardial viability when using Dotarem®     enhanced-cardioMR as the gold standard examination.   "
155038|NCT01254539|"     The purpose of this clinical trial is to assess the feasibility and the security of the     intraspinal and intrathecal infusion of autologous bone marrow stem cells for the treatment     of Amyotrophic Lateral Sclerosis patients.   "
155039|NCT01254526|"     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,     tolerability, and pharmacokinetics of GDC-0980 administered with taxane-based chemotherapy     regimens utilized in patients with locally recurrent or metastatic breast cancer.   "
155040|NCT01254513|"     The objective of this study is to evaluate the feasibility of two different chemotherapy     protocols with adjusted doses for patients aged 75 and over who often have medical problems     other than prostate cancer. Patient will receive Docetaxel either every 3 weeks or weekly. In     both cases, chemotherapy is combined with prednisone. The protocol will be considered     feasible when patient will receive 6 cycles of chemotherapy (1 cycle = 3 weeks).      Additionally to this primary objective, efficacy will also be evaluated for both protocols as     well as tolerance to treatment, quality of life and evolution of geriatric data.   "
155041|NCT01254500|"     Event-related potentials (ERPs）has the advantage of excellent temporal resolution on     measuring real-time neural activities that reflect to higher level cognitive processes. A     research project related to lesion studies in which patients with cognitive function     impairment and communication disorder will be recruited as participants to examine their     impairment as well as residual abilities by using ERPs. Hopefully, expected findings will     provide further analysis based on the patterns of neural activities revealed by both patients     and normal controls should be able to provide important evidence toward building the     cross-linguistic theory. The findings also have applications on diagnostic and evaluation for     patients with brain lesions for clinical application with communication disorder.   "
155042|NCT01254487|"     The purpose of the e-BioMatrix PMS registry is to capture clinical data of the BioMatrix     (Biolimus A9-Eluting) stent system in relation to safety and effectiveness.   "
155072|NCT01254097|"     Antibiotics are lifesaving medicines and generally safe, yet unwanted side effects are     common. While destroying illness-causing 'bad' bacteria, antibiotics can upset the protective     'good' bacteria in the body. This research will test if taking a probiotic with prescribed     antibiotics will decrease the chance of having bothersome antibiotic-associated side effects.   "
155073|NCT01254084|"     The aim of the present study was to investigate the effects of Gynostemma Pentaphyllum tea on     insulin sensitivity in drug-naïve type 2 diabetic patients.   "
155043|NCT01254474|"     Monophasic action potential (MAP) recording plays an important role in a more direct view of     human myocardial electrophysiology under both physiological and pathological conditions. The     MAP method represents a very useful tool for an electrophysiological research in cardiology.     Its crucial importance lies in the fact that it enables the study of the action potential     (AP) of myocardial cell in vivo and, therefore, the study of the dynamic relation of this     potential with all the organism variables what can be particularly helpful in the case of     arrhythmias.      Hundred and fifty patients will be included to explore mapping capabilities in cardiac     chambers in patients suffering from regular or fibrillating tachycardia's with the following     inclusion plan: i) Atrial fibrillation at a total of 50 patients ii) Ventricular fibrillation     or patients at high risk of sudden cardiac death at a total of 50 patients iii) Junctional     tachycardia at a total of 50 patients. We will focus on cardiac activation (depolarization     and repolarization) in this population.   "
155044|NCT01254461|"     The primary purpose of this study is to determine whether the treatment with AZD1981 will     affect the pharmacokinetics of pravastatin.   "
155045|NCT01254448|"     This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619     in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects     with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and     tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to     receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.   "
160704|NCT01180036|"     The primary outcome of this study is to determine whether or not the B cell targeting with     Rituximab is more effective than Cyclosporine in inducing long term remission of proteinuria.   "
155046|NCT01254435|"     Colonoscopy is the gold standard investigation in the screening of colorectal neoplasms. The     investigators hypothesise that visualisation of the colonic mucosa on extubation may be     improved by changing patient position as follows: left lateral position for the right colon,     supine for the transverse colon and right lateral position for the left colon(fixed     positioning). The investigators aim to validate our hypothesis by performing a randomised     control study, comparing mucosal visualisation in patients placed in the 'routine' positions     at the discretion of the endoscopist with visualisation in those placed in the above     described positions. The hypothesis is that fixed positioning confers an advantage.   "
155047|NCT01254422|"     The purpose of this study is to evaluate the safety and immunogenicity of Phase III lots of     the CYD dengue vaccine in a pediatric population in Malaysia.      Primary Objectives:        -  To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD          dengue vaccine in all subjects after each dose.        -  To describe the antibody response to each dengue virus serotype post-Dose 2 and          post-Dose 3   "
155048|NCT01254409|"     The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and     the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.   "
155049|NCT01254396|"     This study will evaluate if an orally disintegrating tablet of sildenafil will have similar     pharmacokinetic properties when given with food and without food.   "
155050|NCT01254383|"     This study will evaluate if an orally disintegrating tablet of sildenafil will have similar     pharmacokinetic properties as the conventional tablet of sildenafil.   "
155051|NCT01254370|"     The purpose of this study is to compare:        -  the effect of Catioprost® and Travatan Z® on the ocular surface disease (OSD) in          subjects with glaucoma or ocular hypertension and ocular surface disease.        -  the intraocular pressure (IOP) lowering effect and safety of Catioprost® and Travatan Z®          in subjects with glaucoma or ocular hypertension and ocular surface disease.   "
155052|NCT01254357|"     As part of Clinical Trials.Gov ID:NCT00253292 a psychometrically sound outcomes instrument     was developed to study the outcomes of burn survivors in the 19-30 year old age group. This     workgroup has come together to re-examine the data collected during the previous study and     determine next steps in understanding the recovery for this population.   "
155053|NCT01254344|"     The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared     with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection     following elective colorectal surgery in Chinese adults. This study is designed to     demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in this     participant population.   "
155054|NCT01254331|"     This open-label, multi-center study in a local environment will evaluate the safety and the     effect on disease activity with regard to reduction in signs and symptoms over 6 months of     treatment in patients with moderate to severe active rheumatoid arthritis who experienced an     inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an     intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in     combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.   "
155055|NCT01254318|"     This will be a retrospective study that includes retrospective chart reviews at major     institutions across Canada. The intent of the study is to generate both regional and national     incidence data for non-Candida invasive fungal infections (IFI) in high risk participants.     The study will include participants receiving stem cell transplant and high dose chemotherapy     treatment for leukemia.   "
155056|NCT01254305|"     The purpose of the study is to evaluate the efficacy, safety and tolerability of     Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder     (MDD).   "
155057|NCT01254292|"     The primary objective of this study is to evaluate user satisfaction and tolerability in     young women (18-29 years of age) using the LCS12 compared with young women using a COC     (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use     of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional,     extension phase. Safety data only will be collected during the extension phase of the study.      Secondary objectives are to observe the tolerability, discontinuation rates, adverse event     profiles, occurrences of unintended pregnancies (including calculation of Pearl Index [PI]),     and bleeding profiles with the two birth-control methods. Additionally, data on missed     tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system     (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician     satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal     threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of     subjects) will be collected. Finally, in the COC group, information will be collected on the     psychosocial impact of missed or delayed pill intake.   "
155059|NCT01254266|"     The major problem in the treatment of morbidly obese children is the long term maintenance of     the reduced weight. Maintenance-focused interventions have not been studied enough in     adolescents with morbid obesity, neither in regard to conservative methods of weight     reduction, nor in regard to bariatric surgeries.      This study will investigate the effectiveness of an integrative, multi-disciplinary inpatient     program for promoting long-term weight maintenance in children with morbid obesity. The     program will be studied in two perspectives: as a conservative treatment, as well as an     'envelope' for bariatric surgeries including a pre-operational preparation phase and a     post-operational follow-up.      The investigators hypothesize that program participants will maintain weight significantly     better than the proportion known in the literature.   "
155060|NCT01254253|"     The purpose of this study is to compare the diagnostic accuracy of hybrid imaging combining     CTCA with low-dose stress-only SPECT vs. coronary angiography for detecting haemodynamic     relevant coronary lesions; and second to determine the effects of PCI on cardiac perfusion,     cardiac function and quality of life in patients with CTO lesion in left anterior descending     (LAD) coronary artery.   "
155061|NCT01254240|"     This is a double-blind prospective randomized monocenter study comparing the efficacy of two     phototherapy ultraviolet spectra on pruritus (itching) of inflammatory skin diseases. 40     patients per treatment, in total 80 study participants.   "
162177|NCT00002047|"     To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in     HIV-infected patients in renal failure receiving maintenance hemodialysis.   "
155063|NCT01254214|"     The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress     Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered     mostly by phone, is an effective program to reduce symptoms (anxiety, depression, sleep) and     improve quality of life for people waiting for a kidney transplant. Participants will be     randomly assigned to tMBSR or to a support group emphasizing communication skills and     selecting resources. Both 8-week programs include an initial in-person meeting, 6 weekly     teleconference calls, and conclude with an in-person meeting. Participants will complete     questionnaires at 3 timepoints over 6 months, and if they receive a transplant, will complete     additional questionnaires. Participants will complete sleep diaries and wear Actiwatches     (similar to a wristwatch) for one week before programs start, and when programs end, to     measure sleep. Participants will provide saliva samples, over 3 days before programs start,     and again when programs end, to measure salivary cortisol, an indicator of stress. tMBSR     participants will record daily home meditation practice.   "
155064|NCT01254201|"     Dry eyes are a very common complaint. In some patients, we can identify the reason for the     dryness; however, in others the dryness has no clear cause. Dryness can lead to eye     irritation, redness, and sometimes changes in vision. Fibromyalgia is a condition of chronic     pain that is poorly understood but seems to have a component of altered sensory processing.     People with fibromyalgia tend to complain of dry and irritated eyes at a higher rate than the     general population. We plan to evaluate patients with dry eye symptoms for abnormalities in     sensory processing and in their autonomic nervous system. We hope to learn about possible     relationships between dry eye symptoms and fibromyalgia in order to better understand and     treat these conditions.   "
155065|NCT01254188|"     This study will further investigate the safety and efficacy of nilotinib in newly diagnosed     chronic myeloid leukemia patients in the chronic phase   "
155066|NCT01254175|"     Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory     diseases in infants and children. This study will evaluate the safety and immune response of     an HPIV3 vaccine in infants and young children.   "
155067|NCT01254162|"     To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum     production on the forehead of healthy male volunteers.   "
155068|NCT01254149|"     The primary purpose of this study is to determine whether topical ophthalmic anesthetics     lower the intraocular pressure in the eye.   "
155069|NCT01254136|"     This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839     in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast     cancer.   "
155070|NCT01254123|"     Myocardial infarction (MI) causes loss of myocytes and may lead to loss of ventricular     function, morbidity and mortality. The most effective therapy is early reperfusion of the     ischemic myocardium by percutaneous coronary intervention (PCI). Reperfusion limits     myocardial ischaemic necrosis, but also induces inflammation, oxidative stress and calcium     overload: a process referred to as reperfusion injury leading to necrosis and apotosis.     Glucagon Like Peptide-1 (GLP-1) is an incretin hormone that has shown to activate     anti-apoptotic enzymes, reducing reperfusion injury. GLP-1 agonists have been demonstrated to     be cardioprotective in several animal studies and in a single small non-randomized clinical     study. In this pilot study we will assess the safety and efficacy of GLP-1 receptor agonist     Exenatide infusion compared to placebo in patients with an acute myocardial infarction     undergoing primary PCI.      A total of 40 patients will be included in this single centre prospective randomised placebo     controlled two-arm pilot study. Patients who are to undergo a primary PCI for a first acute     ST elevation myocardial infarction are randomly assigned to placebo or Exenatide 5ug bolus in     30 minutes, followed by a continuous Exenatide infusion of 20ug/ 24 hours for 72 hours. Blood     samples are obtained for assessment of enzymatic infarct size and Exenatide levels. Side     effects of Exenatide are stringently monitored. Cardiac function will be measured using     Cardiac Magnetic Resonance Imaging (CMRI) and 3D echocardiography at 1 week and 4 months post     MI. Infarct size will be assessed by means of the final infarct size at 4 months post MI as a     percentage of the area at risk at 1 week post MI. Furthermore we will compare the RNA profile     of both groups.   "
155071|NCT01254110|"     Gut protein metabolism that could be influenced by protein supply is involved in the     regulation of several physiological functions such as gut barrier function and represents a     major contribution in the whole-body protein turnover. Intracellular pathways implicated in     the transduction of amino acids effects remained unknown in the human gut. Thus, the aim of     the present project is to evaluate and to understand the effects of amino acids (glutamine,     leucine) on gut protein metabolism (synthesis and degradation) in young healthy humans.   "
168677|NCT00036374|"     The purpose of this study is to evaluate the effectiveness and safety of infliximab     (Remicade) in patients with Juvenile Rheumatoid Arthritis (JRA).   "
155074|NCT01254071|"     This study will be an open-label, randomized, single dose, two-period crossover study to     determine the bioavailability of a fixed dose combination capsule formulation of dutasteride     and tamsulosin hydrochloride (0.5mg/0.2mg) relative to co-administration of dutasteride 0.5mg     capsules and tamsulosin hydrochloride 0.2mg tablets in healthy male subjects of North East     Asian and non-Asian ancestry. Subjects will receive single oral doses of a combination     capsule formulation of dutasteride 0.5 mg/ tamsulosin 0.2 mg in a fed or fasted state or     concomitant dosing of dutasteride 0.5 mg and the Japan-sourced Harnal-D 0.2 mg in a fed or     fasted state. Each dose of study medication will be separated by a 28-day washout period.     Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing.     Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory data,     and review of adverse events. The study will enrol 88 healthy male subjects to ensure that 80     complete the study. At least twenty percent of the study population will be of Japanese     ancestry, approximately 20% will be of Chinese ancestry and approximately 20% of Korean     ancestry while the remainder of the population will be of non-Asian ancestry.   "
155075|NCT01254058|"     The purpose of this study is to determine whether rapid eye movements called saccades are     impaired in glaucoma, a neurodegenerative disease of visual pathways.   "
155076|NCT01254045|"     The purpose of this study is to determine whether the medication oxytocin is an effective and     tolerable treatment in adolescent males with fragile X syndrome (FraX) for improving socially     appropriate behaviors and reducing social anxiety.   "
155077|NCT01254032|"     Chronic Obstructive Pulmonary Disease (COPD) is a major health concern, with a substantial     impact on a patient's life. However, the impact of COPD is currently under-recognised and, as     a result, COPD is under-treated. An exacerbation of COPD is a major element that causes poor     quality of life and loss of productivity. Therefore, minimizing the frequency of     exacerbations is a short term treatment goal in COPD management and could improve Quality of     Life (QoL) significantly in all severity groups of COPD.      Although the use of spirometry for the determination of disease severity in COPD is supported     by guidelines, a lung function test alone does not provide a measurement of the overall     impact of COPD on health status and is not generally available especially in primary care     centre. Therefore, a standardised and effective dialogue between patients and physicians in a     consultation could address the impact of COPD on a patient's QoL in this situation.      The COPD Assessment Test (CAT), recently launched in 2009, is a short and simple,     self-administered questionnaire designed to assess the condition of patients and overall     impact of COPD, and to improve patient-physician communication. It has been proven that the     CAT has good repeatability and discriminative properties which suggest that it is sensitive     to treatment effects at a group level. The CAT score with its better ability to assess the     impact of COPD on patients, suggests potential to predict a significant change in COPD status     such as acute exacerbations of COPD.      Since the CAT is designed to assess the impact of COPD on the patient by measuring overall     impairment, it has better correlations with other instruments, such as the Clinical COPD     Questionnaire (CCQ), MRC (Medical Research Council) dyspnoea scale, St George's Respiratory     Questionnaire (SGRQ),and the 6-minute walk test. However, it does not correlate well with     FEV1 (Forced Expiratory Volume in One Second).      While the CAT shares some similarities with other questionnaires, there are several important     differences. For example, the SGRQ is substantially longer than the CAT, is complex to     administer and requires the use of a computer for scoring. The CAT is designed to provide a     holistic measure of the impact of COPD on the patient, whereas the MRC dyspnoea scale only     measures dyspnoea, and the CCQ only assesses clinical disease control. Thus, the CAT is the     only validated, short and simple assessment test which can provide a holistic measure of the     impact of COPD on patients, ensuring both the physicians and the patients gain the     understanding needed to manage COPD optimally.      QoL is defined as an individual's perception of their position in their life in the context     of the culture and value systems. Therefore, the extent of understanding of the questionnaire     might be influenced by language and ethnicities. Since the validation findings so far have     been based on data from the US and Europe, PACE may provide better quality of data across     ethnic groups given that mainly Asian subjects will participate in this study.      PACE is designed to evaluate whether the CAT has a high predictive value in detecting     subsequent exacerbations of COPD. If so, this result might enable both patients and     physicians to better target and optimise management. The primary objective is to evaluate the     predictability of the CAT to have subsequent exacerbations in COPD patients. Secondary     objectives are to evaluate the predictability of the CAT to have moderate to severe     exacerbations or time to the first exacerbation, to identify risk predictors for COPD     exacerbations, and to evaluate correlations between CAT scores and FEV1 values, or MRC     dyspnea scores. An experimental objective is to evaluate the correlation between the CAT     score between 2 consecutive follow-ups (e.g. Week 8 & baseline, Week 16 & Week 8) and a COPD     exacerbation over the following treatment period adjusting for demographics, MRC scores, lung     function parameters, medical history, and therapy history.      PACE is a multicentre, prospective, observational study designed to evaluate the     predictability of the CAT score to have COPD exacerbations over 24 weeks. During the study,     subjects continue taking their regular prescribed treatment. Investigators are free to make     medication adjustments where required. Eligible subjects will have a clinic visit every 8     weeks, during which they will complete the CAT questionnaire, the Exacerbation Check List     (ECL), MRC dyspnea scale, and spirometry. A regular phone call is placed every 8 weeks in     between clinic visits to collect data for the ECL.There is no follow-up period.      550 male and female outpatient subjects will be recruited for PACE to obtain approximately     300 exacerbation events. This study will capture the winter periods in Australia, China,     Korea and Taiwan, when incidence of exacerbations is at its peak.      Statistical analysis will be performed on subjects' data to derive the PACE end-points.   "
155080|NCT01253993|"     There is clear evidence that aggressive behavior and disruptive behavior disorders (DBD) in     middle childhood are associated with an increased risk for substance abuse in adolescence.     However, the exact underlying mechanism of this increased risk is unknown. It is likely that     a biopsychological vulnerability in some aggressive children and children with DBD makes them     liable to substance use and abuse. The investigators hypothesize that deficient decision     making is such a biopsychological factor. In this study the investigators aim to test the     latter hypothesis by investigating the decision making ability in a group of adolescents with     DBD with and without substance use disorders. Decision-making is assessed with the IOWA     Gambling Task (GT). This task mimics real-life situations in the way it factors uncertainty,     reward and punishment. The GT is specifically designed to assess impaired decision-making in     individuals who are unable to learn from their mistakes and make decisions that repeatedly     lead to negative consequences. This characteristic may be common to individuals with     externalizing disorders such as DBD, psychopathy, and substance use disorders.   "
155081|NCT01253980|"     Paraffin (kerosene) ingestion in the developing world accounts for a large number of visits     to healthcare facilities, especially amongst children. There is no evidence in animals and no     good evidence in humans that the use of early antibiotics improves the clinical outcome of     paraffin-induced pneumonitis. This randomised placebo-controlled trial will investigate     whether the use of early antibiotics affects the clinical course of children with pneumonitis     following paraffin ingestion.   "
155082|NCT01253967|"     The purpose of this hospital based study is to estimate the proportion of rotavirus     gastroenteritis in children < 5 years of age in Romania.   "
155083|NCT01253954|"     The incidence of invasive candida infection (ICI) in critically ill patients is increasing     day by day. The crude mortality of IFI in ICU could be as high as 25%-75% depending on their     age, underlying conditions, and so on. Candida albicans was by far the predominant species in     most countries, causing up to two thirds of all cases of invasive candidiasis. However, a     shift toward non-albicans Candida species has been observed. Although the studies of ICI     cause universal attention recently, there is still no large-scale, multi-center     epidemiological research in China focusing on ICI in critically ill patients, therefore we     conducted a large-scale multi-center observational study of IFI in critically ill patients     named China Scan (CHINA Survey of Candidiasis in ICU) to assess the current incidence,     mortality, pathogen spectrum, management, and risk factors for ICI in China ICUs.   "
155084|NCT01253941|"     Rehabilitation and physical therapy strategies targeting extra pulmonary manifestations of     Chronic Obstructive Pulmonary Disease (COPD)are far from being well defined. Studies,     performed in healthy subjects using threshold breathing device [a simple method to increase     inspiratory muscle load] have shown that ventilatory muscle overactivation during loaded     breathing may prime reactive oxygen species (ROS) production, thus initiating an inflammatory     response that results in elevation of pro-inflammatory cytokines, particularly IL_6. Increase     of cytokine IL_6 in turn, elicits a cascade of systemic responses, involving hormone like     glucoregulatory mechanisms, lipolysis and fat oxidation, as well as control of breathing.      Thermal mud bath therapy has been acknowledged for its antioxidant and anti-inflammatory     effects in several chronic diseases. However, it is not considered among treatment options of     chronic pulmonary disease. Previous experimental studies indicate that trace elements of     thermal treatments, particularly iodide and bromide, may positively intervene in the setup     and maintenance of active state in skeletal muscle. These findings suggest that in COPD     patients these elements may improve the loading and endurance of respiratory muscles and     therefore blunt ventilatory muscle overactivation and the ensuing inflammatory cytokine     response.      In this study the investigators want to test two major hypotheses. First, that mud bath     therapy reduces systemic inflammatory processes in COPD patients, increases respiratory     muscle endurance and normalizes the ventilatory response. Second, that the increase in     systemic inflammation after IRB exercise is blunted by mud bath therapy.   "
155117|NCT01253512|"     This will be a randomized, double-blind, placebo-controlled, multi-center, multi-national,     escalating dose, pilot study comparing two doses of THR-18 to placebo when administered to     patients suffering acute ischemic stroke and treated with Tissue Plasminogen Activator (tPA).      The study hypothesis is that THR-18 will be safe and well tolerated in subjects suffering     acute ischemic stroke and treated with Thrombolysis.   "
168691|NCT00036569|"     Diffuse pontine gliomas are tumors on the pons portion of the brainstem. Their peak incidence     is in children between 5 and 10 years old. Their location makes surgical resection     impossible. Most patients are treated with radiation, which typically delays progression of     the tumor for a median time of only about 6 months; median survival time is less than 1 year.     The addition of chemotherapy has not improved the outcome.      Alpha, beta, and gamma interferons have been used to treat malignant brain tumors, with mixed     results. Different doses and different methods of administration have been studied. Alpha     interferon is usually given in high doses 2 or 3 times a week, but it has serious side     effects at these doses. Recent studies have shown that administering chemotherapy more     frequently at smaller doses (metronomic) may have a better effect against the tumor.      PEG-Intron(Trademark) is a form of interferon alpha combined with monomethoxy polyethylene     glycol (PEG). It has a longer half-life than interferon alone, is administered once a week,     and the long half-life reduces the peaks and troughs in blood levels.      This study will enroll 32 patients under age 21. The primary goals of the study are to     determine if there is a difference in the 2-year survival rate of patients treated with     radiation alone and those treated with radiation followed by PEG-Intron(Trademark) and to     define the toxicities of PEG-Intron(Trademark) in the study doses. Secondary goals are to     evaluate various magnetic resonance imaging (MRI) techniques for noninvasive monitoring of     changes in the brainstem and to evaluate neuropsychological function.      In this study, PEG-Intron(Trademark) will be administered subcutaneously once a week at low     doses (0.3 microgram per kilogram of body weight) for a 4-week cycle. The cycles will be     repeated indefinitely until progression of disease or serious side effects develop. For less     severe effects, the dose will be lowered and the patient may remain in the study. For more     severe effects, the dose will be discontinued. Patients in the study may receive supportive     medication but may not receive other forms of chemotherapy.      Patients or their caregivers will be instructed in how to inject the drug. Patients and/or     caregivers will be asked to maintain a diary documenting the dose, site of administration,     and any side effects. The diary will be reviewed at each National Cancer Institute (NCI)     visit. Patients will return to NCI before cycles 2 and 3. If there are no significant side     effects, patients may then return to NCI before every other cycle, indefinitely (i.e., before     cycles 5, 7, 9, etc.).      Patients will undergo the following tests and procedures:        -  Physical examination, including neurologic exam, monthly        -  Complete blood count, differential, and platelet count weekly during cycle 1 and every 2          weeks thereafter if no severe side effects occur        -  Blood chemistries weekly during cycle 1 and every 2 weeks thereafter if no severe side          effects occur        -  Endocrine function tests before each cycle        -  Urinalysis before each cycle        -  MRI of the brain before cycles 1, 2, 3, 5, 7, and every other month; patients may also          have proton magnetic spectroscopic imaging performed at the time of the MRI   "
155085|NCT01253928|"     Non diabetic patients on renal replacement therapy are prone to changes in body composition     with an increase in visceral fat and muscle wasting all favoured by the insulin resistant     state. Malnutrition is associated with a worst prognosis in these patients. Glitazones are     the most powerful insulin sensitisers available in clinical practice which also have     anti-inflammatory properties. Their use has been associated with significant and favourable     changes in body fat distribution in type 2 diabetic subjects. Experimental studies suggest     that glitazones may attenuate muscle wasting in renal failure.      The goal of this study was to examine in non diabetic ESRD patients the effects of     pioglitazone on inulin sensitivity and protein metabolism as determined by the     hyperinsulinemic euglycemic clamp and on changes in body composition as determined by     anthropometric measurements, dual energy X-ray absorptiometry (DEXA) and CT-scan determined     changes in abdominal visceral and sub-cutaneous fat.   "
155086|NCT01253915|"     This multi-center, double-blind, placebo-controlled, parallel group trial carbon dioxide in     the treatment of moderate to severe migraine. At approximately 8 US sites, approximately 450     patients who meet the eligibility criteria will be randomized to active or placebo in a 1:1     ratio to ensure that 400 patients will treat at least one moderate to severe migraine with     the study drug.      Patients will be randomized to one of two treatment groups and be provided with either an     active or placebo dispenser.      All patients will administer study drug for 10 seconds to each nostril when experiencing a     qualifying headache. Patients will assess their pain and other migraine-related symptoms in a     patient diary. If a patient still has pain and/or any other symptoms after the initial dose     then the patient may opt to take 3 more doses to treat the headache.      Each patient's participation in the study may last up to 56 days or once the patient treats 4     headaches with the study drug, whichever occurs first.      There will be a total of 2 scheduled clinic visits:        -  Visit 1 Screening/Randomization        -  Visit 2 End of Study (within 7 days after the patients treats his/her fourth headache or          after the end of the 56-day treatment period, whichever occurs first)   "
155089|NCT01253876|"     Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats,     inositols might have beneficial effects on weight control and blood pressure management. Most     studies in this regard have been conducted on postmenopausal or premenopausal women and there     are few studies on female youths. Therefore, we are going to determine the effects of soy     consumption on the weight, waist circumference and blood pressure in overweight and obese     female youths. This was a cross-over randomized clinical trial which was conducted in 2010 in     Isfahan on overweight or obese young female youths. After three weeks run-in, females were     randomly assigned to consume a diet containing caw's milk or a diet in which only one glass     of soy milk was substituted; each one for six weeks. Random sequencing generated in SPSS was     used for allocating females in different group randomly. Patients were not blinded because     they had to use soy milk in one period of trial and use caw's milk in another period.   "
155090|NCT01253863|"     The purpose of this study is to determine the accuracy of preoperative clinical examination     in penetrating injuries   "
155091|NCT01253850|"     HIV is increasing among adolescents and young adults in the US. Antiretroviral medications,     when taken correctly (≥90% of prescribed doses taken), can vastly improve life expectancy.     However, adherence among HIV-infected young people is suboptimal, and few interventions are     available to help adolescents adhere to treatment.      The first phase of the study is an intervention development phase, which includes conducting     interviews with 40 HIV-infected youth for input on the adaptation of the approach. The     information obtained from the qualitative interviews is used to adapt the Life-Steps     intervention (designed by our group for HIV-infected adults) to be responsive to the needs of     HIV-infected adolescents, with acceptability of topics and content, and feasibility of     intervention delivery to be tested in an open pilot trial.   "
155092|NCT01253837|"     The recombinant human fusion protein L19TNFα was created with the intention to overcome the     systemic toxicity of TNFα by directly targeting it to tumor tissues. Tumor-targeted L19TNFα     would result in high and sustained intralesional bioactive TNFα concentrations.   "
155093|NCT01253824|"     The purpose of this study is to compare the serum levels of estradiol, progesterone, FSH and     LH in NPC-01 or IKH-01 one treatment cycle with those in before and after administration     cycle.   "
155094|NCT01253811|"     This trial will be conducted in Asia, Europe and the United States of America (USA).      The aim of this clinical trial is to investigate long-term safety of rFXIII when administered     for prevention of bleeding episodes in children aged between 1 and 6 years with congenital     FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760 (mentor™4,     NCT01230021). If applicable the trial will be extended up to maximum 3 years dependent on     when recombinant factor XIII will be commercially available in subject's respective country     for use in children of 1-6 years of age.   "
155095|NCT01253798|"     The purpose of this study is to determine which group exercise one should choose when hip     osteoarthritis patients have undergone hip replacement surgery. To determine this, we want to     answer the following research question:      Are there differences in function and muscle strength in osteoarthritis patients who conduct     group training either on land or in water in the rehabilitation phase following hip     replacement surgery?   "
155096|NCT01253785|"     Validate pulse oximeter sensor SpO2 accuracy from 70-100% during induced hypoxia.   "
155097|NCT01253772|"     Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples     during cardiac surgery.   "
155098|NCT01253759|"     This is a report of 10 years results of combined Transpupillary thermotherapy (TTT) treatment     with Indocyanine green (ICG) in controlling small and medium-sized choroidal melanomas.   "
155099|NCT01253746|"     The Genetics of Neural Tube Defects Study at the University of Miami: The University of Miami     John P. Hussman Institute for Human Genomics is looking for families to participate in     research to identify the genetic and environmental factors that contribute to Neural Tube     Defects (NTD). Our research goal is to better understand the genetic and environmental causes     of both open NTD, like spina bifida and anencephaly, and closed NTD, like lipomeningocele and     tethered cord. This will eventually lead to more accurate genetic counseling and risk     assessment, improved treatments, and better prevention methods. Any individual with a     diagnosis of NTD and his/her selected family members can participate, if willing.     Participation is free. Travel is not required. Participation involves reading and signing a     consent form, providing a blood sample, a family and medical history interview, and granting     the research staff permission to review the medical records of the individual(s) with NTD. We     maintain the highest standards of confidentiality for all families. If interested, please     contact Maria Ciliberti, the study coordinator, at 1-877-686-6444 (toll free) or directly at     305-243-4360, or by email Mciliberti@med.miami.edu . Please visit our web site at     www.hihg.org for more information.   "
155100|NCT01253733|"     UCSD researchers are conducting a study aimed to develop and evaluate a chronic disease self     management web and text message based program on health-related self-efficacy and frequency     of adolescent-conducted healthcare interactions. We hypothesize that users of the program     will demonstrate greater gains between baseline and 8 month measures of health related     self-efficacy and adolescent-conducted healthcare interactions as compared to the usual care     comparison group.   "
155101|NCT01253720|"     UC San Diego researchers conducted a study to develop and evaluate an internet and text     message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors.     We hypothesized that those study participants randomized to the intervention will demonstrate     greater reduction in BMI-z score as compared to the control group.   "
155102|NCT01253707|"     First in human, open-label, sequential dose escalation and expansion study of AMG 337 in     subjects with advanced solid tumors.   "
155103|NCT01253694|"     Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to     Bevacizumab.   "
155104|NCT01253681|"     To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well     tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial     ovarian, primary peritoneal and fallopian tube cancers. The hypothesis is that AMG 386 in     combination with carboplatin and paclitaxel is safe and well tolerated.   "
155529|NCT01248104|"     We hypothesize that tranexamic acid administration will be associated with 25% improvement in     the volume of blood loss and red blood cell (RBC) administration, with no increase or a     decrease in perioperative complications   "
155105|NCT01253668|"     This is a phase II study of an investigational agent, brivanib, in patients with refractory     metastatic renal cell carcinoma. This study will evaluate the safety and effectiveness of     brivanib in renal cell carcinoma, and explore the activity of this drug in this population to     determine whether imaging and molecular features of the tumors can be used to predict     response. Approximately 30 people with advanced kidney cancer will be enrolled on this study     at the University of Pennsylvania.   "
155106|NCT01253655|"     The purpose of this study is to evaluate the relationship between plasma drug levels and     receptor binding in brain using PET; and to evaluate safety and tolerability after a single     administration of PF-05212365 in healthy volunteers   "
155107|NCT01253642|"     This phase II trial studies how well giving phenelzine sulfate together with docetaxel works     in treating patients with prostate cancer that is growing, spreading, or getting worse after     first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work     better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together     with docetaxel may kill more tumor cells.   "
155108|NCT01253629|"     This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective     in treating the behavioral symptoms of Fragile X Syndrome.   "
155109|NCT01253616|"     This is a proof-of-concept study designed to provide feasibility information on the clinical     use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus.     The study is expected to give preliminary efficacy and safety information.   "
155110|NCT01253603|"     This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free     patients with mild to moderate persistent asthma.   "
155111|NCT01253590|"     The purpose of this study is to assess whether it is possible and acceptable to monitor     patients at a distance who experience a condition called atrial fibrillation after their     cancer surgery. Some patients have no other clinical reason for staying in the hospital after     cancer surgery except in order to control their heart rhythm. Being able to send these     patients home earlier and monitor them at a distance from their home can be good for their     quick recovery. Studies have shown greater quality of life and patient satisfaction when     patients are monitored at a distance for conditions like atrial fibrillation, however cancer     patients have not been studied.   "
155112|NCT01253577|"     The purpose of this study is to assess the safety and efficacy of the Propel mometasone     furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients     with Chronic Sinusitis (CS).   "
155113|NCT01253564|"     This open-label study will assess the safety and efficacy of RO5185426 in previously treated     metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose     of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.   "
155114|NCT01253551|"     The purpose of this study is to confirm the absence of a clinically relevant interaction     between telaprevir and raltegravir at steady-state.Telaprevir is being investigated for the     treatment of chronic hepatitis C virus infection, and raltegravir is used to treat HIV     infection.   "
155115|NCT01253538|"     The purpose of this study is to examine effective methods of preventing the transmission of     HIV from mother to child during pregnancy, labor, and delivery. This is one part of the     three-part PROMISE study. This study will be conducted at resource-limited locations in     Africa and other parts of the world where women typically receive a short course of highly     active antiretroviral therapy (HAART) during pregnancy and where formula feeding (FF) is     standard.   "
155116|NCT01253525|"     Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in     combination with paclitaxel.   "
155124|NCT01253421|"     The purpose of this study is to evaluate the effects of a single low dose of the D2/D3     antagonist amisulpride on reward processing. More generally, this study will test the role of     dopamine (a naturally occurring brain chemical) in depression.      Hypotheses:      Administration of a single low dose of the D2/D3 antagonist amisulpride will (1) improve     performance in a behavioral task assessing learning from feedback and (2) boost activation in     reward-related brain regions.   "
155125|NCT01253408|"     Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no     effective and safe medications approved for the treatment of abdominal pain associated with     bowel symptoms in IBS. This study will investigate the effects of an approved medication,     Dronabinol, on the movement of food through the stomach and colon in subjects with a history     of diarrhea-predominant Irritable Bowel Syndrome (D-IBS).      Dronabinol is a synthetic medication (a medication made in a laboratory) related to the     active ingredient of cannabinoid or marijuana. Dronabinol is approved by the Food and Drug     Administration (FDA) for preventing nausea and vomiting in patients with cancers undergoing     chemotherapy. It is also used in AIDS patients with excessive weight loss for improvement in     appetite and weight gain.      The hypothesis in this study is that dronabinol will slow down the movement of food through     the colon, and that this effect is regulated by the genes controlling the body messengers     (receptors) that respond to medicinal marijuana or synthetic medicines that work on the same     messengers that are present in the gastrointestinal tract and pain nerves.   "
155126|NCT01253395|"     Randomized equivalency trial of the effects of strength training compared to aerobic exercise     on pain severity in adults with fibromyalgia.   "
155127|NCT01253382|"     The primary objective of this study is:        -  assess the safety and tolerability of ecallantide in paediatric patients for acute          attacks of HAE      The secondary objectives are:        -  evaluate the pharmacokinetic profile of ecallantide in paediatric patients treated for          acute attacks of HAE        -  assess the efficacy of ecallantide in paediatric patients treated for moderate to severe          acute attacks of HAE   "
155128|NCT01253369|"     Pazopanib is a drug that inhibits proteins thought to be important for new blood vessel     formation. This drug has been used in other cancer research studies and information from     those studies suggests that pazopanib may help block proteins that are important for the     growth, invasion, and spread of cancer cells.   "
164866|NCT00005442|"     To conduct a comprehensive epidemiologic investigation into the relationship between serum     triglyceride (TG) levels and coronary heart disease (CHD).   "
155129|NCT01253356|"     The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing     major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30     days compared with standard care alone, while maintaining acceptable safety with respect to     vascular accesss-related complications.   "
155130|NCT01253343|"     Violence and aggression on pediatric psychiatry units has led to staff and patient injuries     and even deaths around the country. In an effort to improve safety, the investigators have     developed a method (with the Brief Rating of Child and Adolescent Aggression) of identifying     children and adolescents at a higher risk for aggression and violence on the units. In order     to improve this prediction, the investigators plan to study salivary hormones in low risk     children and high risk children. The salivary hormones to be studied include cortisol,     testosterone, and dehydroepiandrosterone sulfate (DHEAS). The investigators expect to improve     the investigators current ability to predict the severity and type of pediatric aggression     and violence on the inpatient units by combining information from the Brief Rating of Child     and Adolescent Aggression (BRACHA), the Predatory-Affective Aggression Scale (Vitiello et     al., 1990), and salivary hormones.   "
155131|NCT01253330|"     The purpose of this randomized crossover study is to determine the efficacy of participant     designed medication reminders on asthma control, asthma related quality of life,and     medication adherence. In addition, this study will provide data regarding the usage,     usability, acceptability of an online system designed for creating text message reminders. It     is hypothesized that the teens receiving text message reminders will report having greater     quality of life related to their asthma, a reported increase in the control of their asthma,     and increased adherence to their medication regimen compared to those teens that are not     receiving the text message reminders.   "
155132|NCT01253317|"     The investigators are recruiting children for a research study using a medication known as     IGF-1 (mecasermin or INCRELEX) to see if it improves the health of children with Rett     syndrome (RTT). To participate in the study your child must be female, between the ages of 2     to 12 and have a genetic diagnosis (MECP2 deletion or mutation) of Rett Syndrome. As you may     know, there is no treatment for this illness. Currently, the standard management of Rett     syndrome is supportive, which means attempting to prevent complications and treatment of     symptoms.      This study involves testing an investigational drug, which means that even though IGF-1 is     approved by the Food and Drug Administration (FDA) for use in children, it has not been used     before to treat Rett syndrome specifically. Information from this research will help     determine whether the drug should be approved by the FDA in the future for the treatment of     Rett Syndrome.      There are five major goals to this study:        1. As one of the features of Rett Syndrome is unstable vital signs, the investigators are          trying to determine if IGF-1 has any effect on normalizing your child's pulse, blood          pressure and breathing pattern.        2. The safety of IGF-1 in children with Rett syndrome. The study personnel will ask you to          complete a medication diary and side effect reporting form on a regular basis. They will          assist you in completing this by telephone interviews. Your child will undergo 2 lumbar          punctures performed at the bedside in the clinical research facility. In addition,          laboratory tests will be performed throughout the study to evaluate the safety of IGF-1.          These will be blood tests similar to those provided in routine clinical care. Your child          will undergo regular non-invasive comprehensive physical examinations including          neurological and eye examination, tonsil evaluation, electrocardiograms (ECG),          measurement of height, weight and head circumference.        3. IGF-1 may improve your child's behavior, communication and speech. In order to measure          this, the investigators will evaluate your child once during each month of treatment          with neurodevelopmental assessments and a neurological exam. Investigators will also ask          you about her behavior and day-to-day functioning through a structured parental          interview and questionnaires.        4. We will examine your child's cortical function through use of electroencephalography          (EEG) in conjunction with presentation of visual and auditory stimuli. EEG is a          non-invasive way of recording the electrical activity of your child's brain.        5. Children with Rett Syndrome sometimes experience flushing in their cheeks or have          exceptionally cold hands or feet and/or abnormal perspiration. The Qsensor® is a          non-invasive device worn on a fabric bracelet that continually measures your child's          perspiration level and body temperature. We would like to use the Qsensor® to determine          whether or not IGF-1 improves these symptoms.   "
155133|NCT01253304|"     The primary purpose of this study is to help answer the following research questions, and not     to provide treatment for any condition:        -  To evaluate how much of the study drug (LY2189265) is in the blood of participants with          varying degrees of liver impairment compared to those with normal liver function.        -  To assess the safety of LY2189265 and any side effects that might be associated with it.   "
155423|NCT01249495|"     The purpose of this study is to investigate the rate of wound healing using sharp debridement     using curette and to compare between such intensive treatment at hospital and treatment in     primary care. A correlation between change in wound size and pro-inflammatory cytokines will     also be made.   "
155134|NCT01253291|"     The objective of this study is to evaluate the safety and tolerability of 48 weeks     subcutaneous dosing with LY2127399 for patients who have participated in a prior LY2127399     clinical study. At the end of the 48 week treatment period, patients will participate in a 24     week follow up period. Additional follow up after week 72 may continue to assess B cell     recovery.   "
155135|NCT01253278|"     The study drug LY2393910 is being evaluated as a possible treatment for diabetes. The primary     purpose of a patient's participation in this study is to help answer the following research     question(s), and not to provide treatment for diabetes:        -  The safety of LY2393910 and any side effects that might be associated with it following          2 weeks of doses        -  How long it takes the body to absorb and remove LY2393910 following dosing over 2 weeks        -  How daily dosing of LY2393910 affects blood levels of sugar (glucose), insulin and other          naturally occurring substances in your body        -  How daily dosing of LY2393910 affects the cells that produce insulin        -  Any differences in the above between LY2393910 taken as daily doses in the morning or in          the evening   "
155136|NCT01253265|"     The purpose of this study is to evaluate the safety and tolerability of multiple doses of     LY2439821 in Japanese patients with rheumatoid arthritis.   "
155137|NCT01253252|"     The purpose of this study is to determine whether Positron Emission Tomography imaging can     help to predict the evolutivity of AAA treated with endovascular prosthesis.   "
155138|NCT01253239|"     The purpose of this study is to evaluate the visual performance of two cohorts of patients     who received multifocal intraocular lenses following cataract and clear lens extraction     surgeries. Comparing visual outcomes of patients who were implanted with TECNIS Multifocal     IOLs in both eyes versus patients implanted with TECNIS Multifocal in one eye and ReZoom     Multifocal IOL in the opposite eye.   "
155139|NCT01253226|"     This study will evaluate the safety and tolerability of multiple doses of LY2127399 in     Japanese patients with rheumatoid arthritis (RA).The study consists of a 20 week treatment     period. All subjects will be followed up for 12 weeks after the last study drug     administration.   "
155955|NCT01242488|"     The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and     immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who     have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.   "
155140|NCT01253213|"     The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2     expression in human prostate by ultrasound molecular imaging.      This will be compared with histopathology analysis (location based on expression of VEGFR2 in     tissue specimens determined by immuno-histochemistry, IHC).   "
155141|NCT01253200|"     The purpose of the BLOCk-CTI study is to evaluate the safety and effectiveness of the Blazer®     Open-Irrigated Ablation Catheter for the treatment of sustained or recurrent type 1 atrial     flutter. This study will compare outcomes in patients treated with the Blazer® Open-Irrigated     Ablation Catheter to outcomes in patients treated with open-irrigated radiofrequency ablation     catheters that have received FDA market approval for the treatment of type 1 atrial flutter.   "
155142|NCT01253187|"     The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive     containing drospirenone and ethinylestradiol) with or without levomefolate calcium     (Metafolin, a registered vitamin supplement) in the body and to examine and compare the     uptake of levomefolate calcium with or without YAZ in the body, in healthy volunteers not     using hormonal contraception   "
155143|NCT01253174|"     The purpose of this study is to examine and compare the uptake of Yasmin (oral contraceptive     containing drospirenone and ethinylestradiol) with or without levomefolate calcium     (Metafolin, a registered vitamin supplement) in the body and to examine and compare the     uptake of levomefolate calcium with or without Yasmin in the body, in healthy volunteers not     using hormonal contraception.   "
155144|NCT01253161|"     The goal of this clinical research study is to learn if the study drug, Pasireotide LAR can     shrink or slow the growth of Metastatic Neuroendocrine Carcinomas. The safety of this drug     will also be studied. The patient's physical state, changes in the size of the tumor, and     laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and     effective.   "
155145|NCT01253148|"     The purpose of this study is to see if Therasphere will be a better way to treat     cholangiocarcinoma. The investigators want to find out what effects, good and/or bad, this     treatment will have on the patient and their cancer.   "
155146|NCT01253135|"     The objective of this study is to evaluate the potential inhibitory effects of HP802-247     Vehicle on wound closure (healing), by comparing mean days to closure of superficial     (partial-thickness) thermal wounds against similar wounds treated with white petrolatum.   "
155147|NCT01253122|"     A randomised four way crossover design in which each subject will receive two dose levels of     TRx-0037 and two doses of TRx-0014 over approximately a four week period in randomised order.   "
155148|NCT01253109|"     This study monitors the intraocular pressure (IOP) over 4 to 6 hours using the SENSIMED     Triggerfish® device and Goldmann Applanation Tonometry (GAT) in pigment dispersion syndrome     and pigmentary glaucoma patients. The aim of the study is to detect SENSIMED Triggerfish®     output signal peak after induced fluctuation by physical exercise or pupil dilation.   "
155149|NCT01253096|"     Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and     safety of intratumorally administered L19IL2 in patients suffering from metastatic melanoma.   "
155150|NCT01253083|"     Background:      - People who have cerebral palsy often have difficulty walking and moving their legs.     Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which     means that early motor skill development can be affected and can have repercussions for later     development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury)     have shown that it is important to start intensive therapy soon after the injury, and it may     be true that starting intensive therapy at a young age will be helpful for children with     cerebral palsy. Researchers are interested in testing the effectiveness of a special body     weight support system for mobility training in young children who have or are at risk for     cerebral palsy.      Objectives:      - To study the effectiveness of a mobility training program on the motor skills of young     children who have or are at risk for cerebral palsy.      Eligibility:      - Children between 12 and 36 months of age who have delayed motor skills and either have been     diagnosed with cerebral palsy or show evidence of spasticity or brain damage.      Design:        -  This study involves two 6-week study phases: a baseline phase and a mobility training          program.        -  Participants will be screened with a physical examination and medical history.        -  During the baseline phase, participants will have mobility testing sessions once every 2          weeks. These tests will measure motor development and ability, including ease and speed          of walking.        -  Participants' parents/guardians will receive a mobility sensor for the child to wear at          home for at least 6 hours (awake time) to measure activity and mobility levels outside          of the testing sessions.        -  After 6 weeks of baseline testing, participants will have 6 weeks of mobility training          for 30 minutes 3 days per week. Training will involve motor tasks with weight support,          conducted by a pediatric physical therapist. Activities may include walking, climbing          inclines or steps, or squatting to reach toys. All sessions will be videotaped.        -  To evaluate the effects of the therapy program, participants will have testing sessions          every 2 weeks.        -  Parents/guardians will also complete questionnaires to provide feedback on the          effectiveness of the therapy program.   "
155151|NCT01253070|"     This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating     older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving sorafenib tosylate and combination chemotherapy may be an effective     treatment for AML.   "
155152|NCT01253057|"     Several epidemiological studies found that exposure to antineoplastic agents were associated     with some reproductive, carcinogenic effects, higher rates of advance micronuclei (MN),     sister-chromatic-exchange (SCE) and spontaneous abortion. Cleaning staff were potentially     exposed to these agents while cleaning ward, ward toilet or other area.      One medical center and one area hospitals in Taipei.Surface wipe samples were collected in     the cleaning staff work area, such as ward environment and ward toilet. Urine and blood     samples of subjects were collected for exposure examinations. Platinum-containing drugs     (Cisplatin, Carboplatin, Oxaliplatin) were used as indicator drugs in environmental (surface     wipe samples) and biological (urine and blood samples) samples.      A self-administered questionnaire was used to collect demographic data, working practices,     medical and contact history, and perceived work-related symptoms of cleaning staff.      The results of this study will be to reduce exposure to cleaning staff.   "
155153|NCT01253044|"     This trial compares two psychotherapies, Acceptance and Commitment Therapy (ACT) and Present     Centered Therapy (PCT), for veterans of the conflicts in Iraq and Afghanistan. We hypothesize     that ACT will be more effective than PCT at reducing emotional distress and improving     functioning. We further hypothesize that both interventions will be highly acceptable to     participants.   "
155238|NCT01251939|"     Patent ductus arterious(PDA)is frequently seen and potentially pathologic in preterm infants.     Near-infrared spectroscopy is a simple bedside tool to analyse the changes in the renal and     splanchnic tissue oxygenation index and fractional tissue oxygen extraction and may be     helpful to measure effects of ibuprofen treatment for PDA in preterm infants.   "
155154|NCT01253031|"     Hearing loss is one of the most common health concerns affecting 1 in 3 Americans over 60     years of age rising to 1 in 2 for those over 85 years old. Contributions to hearing abilities     provided by cognitive and memory processes are universally recognized as essential to     adequate speech communication, but these processes are not well understood. Cognitive     limitations in the ability to rapidly process sequential sounds occur with all listeners but     may have more impact on older Veterans with and without hearing impairment. The purpose of     this study is to examine and more thoroughly characterize the change in auditory working     memory with hearing loss and increasing age. Young and older listeners with and without     hearing loss will listen and report on two target sounds embedded in a stream of rapidly     occurring sound. The investigators expect that older listeners without hearing loss will have     more difficulty than young listeners but that older listeners with hearing impairment will     have the most difficulty with this task even when the sounds they are listening to are     adjusted to compensate for their hearing loss.   "
155155|NCT01253018|"     Robotic devices are capable of providing therapy to the arm of patients with weakness due to     stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of     the weak arm for real life situations often remains limited. The goal of this study is to     determine the best way to use robotic devices and functional task training to improve the use     of the stroke affected arm for real life situations. A secondary goal of this study is to     determine how or if specific areas of the brain are excited before and after training. The     use of a safe and painless magnetic field directed at the brain called transcranial magnetic     stimulation (TMS) will be used at set intervals to gain a better understanding of brain     activity during recovery.   "
155156|NCT01253005|"     This study will investigate the effects of particle size of different triglyceride emulsions     as well as the dynamics of intragastric structure formation and breakdown of the emulsions on     GI function, the kinetics of the endocrine and the satiation response in healthy volunteers.     12 healthy participants will be studied on four occasions on four separate days in a double     blind randomized design   "
155157|NCT01252992|"     Tuberculous paradoxical reactions (PR) are immune reactions occurring during the course of     antituberculous treatment and leading to a worsening of tuberculous symptoms after an initial     improvement. This phenomenon has very extensively studied in HIV infected patients where it     corresponds to the so called IRIS (immune reconstitution syndrome). However, it laso occurs     in non immuno-compromized patients, especially those with extra-pulmonary localization of     tuberculosis. The aim of the study is to look for risk factors of paradoxical reaction in non     immuno-compromized patients with extra-pulmonary tuberculosis. The investigators will     consider clinical, radiological and biological variables, including specific immune and     genetic markers. Our secondary goals are to estimate the incidence of PR, describe their     natural history; characterize the type of immune response they correspond to, and look for     better diagnostic tools.The immunological characterization and the finding of predictive     factors of PR, especially the genetic ones will allow a better understanding of biological     mechanisms that lead to their occurrence during extra-pulmonary tuberculosis treatment. The     establishment of predictive criteria could permit a better surveillance of at risk patients     for a rapid treatment, or even a prevention of PR. The establishment of new diagnostic     criteria at the time of PR could avoid numerous invasive diagnostic procedures, surgery     and/or useless prolongation of antibiotic treatment.   "
155158|NCT01252979|"     The current study is a prospective evaluation of the ability of ketosis to shift     mitochondrial DNA (mtDNA) heteroplasmy in subjects harboring a known mutation in their mtDNA     at position 3243 (A>G). Subjects will be given supplemental medium chain triglycerides (MCTs)     for a period of 6 months. mtDNA heteroplasmy will be measured 3 months prior to treatment, at     treatment initiation, and 6 months after initiation.      The primary objective of the current study is to determine if there is a shift in     heteroplasmy in patients harboring the 3243 A>G mtDNA mutation to a more favorable (higher     wild-type) profile while in a state of ketosis.   "
155159|NCT01252966|"     This randomized clinical trial tested the effects of a computerized (web-based) cognitive     training intervention on smoking cessation.      All participants received 8 weeks of standard nicotine patch therapy, smoking cessation     counseling, and were randomized to 1 of 2 different training programs: cognitive training vs.     control training.   "
155200|NCT01252433|"     The purpose of this research is to investigate children's responses to incorporating     vegetables into selected entrees and snacks over several days. The hypothesis is that     children will increase their vegetable intake by consuming foods that have been reduced in     energy density through the addition of vegetables. Effects on energy intake will also be     examined.   "
155160|NCT01252953|"     The Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification (REVEAL)     trial aims to determine whether lipid modification with anacetrapib 100mg daily reduces the     risk of coronary death, myocardial infarction (MI) or coronary revascularization     (collectively known as major coronary events) in patients with circulatory problems who have     their Low-density Lipoprotein (LDL) cholesterol level treated with a statin.   "
155161|NCT01252940|"     The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is     to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate     (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or     fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor     (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically     suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment     option to patients who wish to simplify dosing by reducing pill burden or to improve the     tolerability of their treatment.      Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which     participants will switch treatment regimens at the start of the study, and the Stay on     Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their     baseline regimen during the first 24 weeks of the study (designed to provide an initial     active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit.      After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF     STR per protocol before switching to a commercially available source.   "
156049|NCT01241240|"     This study will evaluate the safety and efficacy of Triple Combination Therapy compared with     Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary     open-angle glaucoma or ocular hypertension.   "
155162|NCT01252927|"     The main objective of the proposed study is to evaluate the efficacy of a gatekeeper training     suicide intervention program, Applied Suicide Intervention Skills Training (ASIST), in     improving medical students' knowledge about suicide intervention, impact of attitudes on     someone at risk for suicide and competent use of intervention skills to recognize risk and     intervene effectively compared to medical education as usual. This research project will be     undertaken using a randomized-controlled trial design. Questionnaires and objective     structured clinical examinations using simulated patients will be completed at three time     points: 1) before training, 2) after training, and 3) at one year following the training.     Medical students' clinical skills in recognizing risk and intervening with simulated     patients, as well as knowledge about suicide intervention and the impact of attitudes on     someone at risk for suicide will be evaluated.   "
155163|NCT01252914|"     The purpose of this study is to assess the efficacy and safety of one iStent supra stent in     the reduction of intraocular pressure associated with primary open-angle glaucoma.   "
155164|NCT01252901|"     The Wilms' tumor suppressor gene 1 (WT1) encodes for a transcription factor which plays an     important role during urogenital development. Patients carrying a WT1 germline mutation show     symptoms like proteinuria, Wilms tumors, genital malformations and kidney failure. Milder     variants are possible and classification is not always possible. In this registry we are     collecting detailed clinical data of affected individuals to establish genotype-phenotype     correlations with the greater goal to optimize patient care.   "
155165|NCT01252888|"     The purpose of this study is to assess efficacy and safety of two iStents for the reduction     of intraocular pressure associated with primary open-angle glaucoma.   "
155166|NCT01252875|"     The aim of this study is the evaluation of two usual care strategies after stroke or TIA :     achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will     use the statin and titrate the dosage to achieve the target assigned by randomization in     monotherapy or in combination with ezetimibe or other drugs.      The primary end-point is the occurrence of recurrent non fatal stroke, non fatal MI, and     vascular death in each group.      3760 patients will be recruited and followed for eight and a half years maximum.   "
155167|NCT01252862|"     The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of     two iStent devices in eyes of subjects with primary open-angle glaucoma   "
155168|NCT01252849|"     The purpose of this study is to evaluate the safety and efficacy of the iStent medical device     that is implanted into the eye and designed to reduce eye pressure in patients with your     condition.   "
155169|NCT01252836|"     Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.   "
155170|NCT01252823|"     The purpose of this study is to use implantable loop recorder (ILR) in patients under chronic     hemodialysis to record arrhythmias and conduction disorders and correlate them with     hemodialysis parameters.   "
155171|NCT01252810|"     To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when     compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either     chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive     heart failure (CHF) NYHA Class III or greater, who are referred for a coronary     catheterization procedure with or without PCI.   "
155172|NCT01252797|"     This study will investigate the safety, tolerability, and effectiveness of changing the order     of receiving radiation therapy for treating brain cancer. The investigators hope that     changing the sequence of radiation therapy will lower the risk of cancer spreading throughout     your spinal fluid, which covers your brain and spinal cord.   "
155173|NCT01252784|"     The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity     conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with     higher risk MDS.   "
155174|NCT01252771|"     The study aims to investigate the concept of computer based Phosphate Kinetic Modeling (PKM)     in the hemodialysis patient population. This computerized algorithm model was developed as a     tool to aid physicians in controlling a hemodialysis patient's phosphate level. Once a     subject consents to participate in the study, the subject's dietary phosphate intake will be     estimated by the modeling program and the appropriate dose of the phosphate binder calcium     acetate (PhosLo) will be recommended accordingly. If necessary, the Ca++ concentration of the     dialysate will be changed to remove any excess calcium absorbed as the result of an increase     in the PhosLo prescription to control phosphorus.   "
155201|NCT01252420|"     The purpose of this study is to determine whether a limited duration of treatment (two weeks     of low molecular weight treatment) is a safe and effective treatment for distal deep vein     thrombosis of the lower limb.   "
155202|NCT01252407|"     The purpose of this study is to determine acute effect the transctutaneous electrical nerve     stimulation in sympathetic and parassympathetic system in individuals with heart failure.   "
155175|NCT01252758|"     The drug product albuterol sulfate DPI, TBS-7, is a single dose inhalation product of     albuterol sulfate containing 240 ug albuterol sulphate (200 ug of albuterol) and inhalation     grade lactose in a new dry powder delivery system called the Trivair deposition system.      Three different doses of albuterol sulfate DPI, TBS-7, will be administered in this dose     ranging clinical trial: an optimal dose, 80% of the optimal dose and 50% of the optimal dose     and will be compared with placebo and an active comparator.   "
155176|NCT01252745|"     This clinical trial will compare the pharmacokinetic profile of testosterone after repeated     intranasal administration of TBS-1 of different strengths in subjects with hypogonadism   "
155177|NCT01252732|"     The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of     oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic     benefit of oritavancin administered as a single 1200 mg IV dose.   "
155178|NCT01252719|"     The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of     oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic     benefit of oritavancin administered as a single 1200 mg IV dose.   "
155179|NCT01252706|"     The aims is to evaluate the rate of exposure to alcohol, psychoactive substance and nicotine     among pregnant women in periphery hospital (Poria) and in the center of Tel Aviv (Ichilov)     and to evaluate study Brief Intervention impact on reduction exposure, and its effect on     newborn outcomes.   "
155180|NCT01252693|"     The aim of this study is to assess the safety and efficacy of a monthly regimen of ozarelix     administered subcutaneously (SC) versus Goserelin depot administered subcutaneously in men     with Prostate Cancer. This is an international, multi-center, randomized, open label 84 days     study. Men who are at least 18 years of age or older, with histologically proven prostate     cancer of all stages, in whom endocrine treatment is indicated will be eligible for study     entry.   "
155181|NCT01252680|"     This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in     healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A     vaccines were evaluated.   "
155182|NCT01252667|"     This phase II trial studies the side effects and how well clofarabine works when given     together with low-dose total-body irradiation (TBI) in treating patients with acute myeloid     leukemia (AML) undergoing donor peripheral blood stem cell transplant (PBSCT). Giving     chemotherapy and TBI before a donor PBSCT helps stop the growth of cancer cells. It may also     stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem     cells from a donor are infused into the patient they may help the patient's bone marrow make     stem cells, red blood cells, white blood cells, and platelets.   "
155183|NCT01252654|"     Emtosecond lasers are used in cutting the flap in LASIK procedures (laser corrective surgery     for refractive error). Their use has decreased the incidence of serious complications when     compared to the use of microkeratomes(mechanical blades). The commonest femtosecond laser     currently used is 'Intralase'. A newer femtosecond laser 'Visumax' (Zeiss) is now available     and differs from the Intralase in that it does not interfere with the curvature of the cornea     when creating the flap. The Intralase applanates the cornea flat during flap creation which     causes the intraocular pressure to be higher. Both Intralase and Visumax lasers are available     to patients and surgeons to use at SNEC. The aim of the investigators study is to compare the     two lasers in a randomization of left and right eyes in the same patient. The investigators     want to measure any difference that the lower intraocular pressure may have during the     creation of the flap. This will be measured with a questionaire on patient experience during     the procedure and the outcomes of vision, refraction, contrast sensitivity, wave-front     analysis, tear function,corneal sensation and flap thickness measured with anterior segment     OCT during the post-operative follow up period. To date no-one has compared the use of these     two femtosecond lasers. Both lasers are currently used clinically for flap creation at SNEC.   "
155184|NCT01252641|"     This research study is being carried out to study a new way to possibly treat human     immunodeficiency virus (HIV). The agent is called SB-728-T which are CD4+ T-cells obtained     from an individual that are genetically modified at the CCR5 gene by Zinc Finger Nucleases.     The CCR5 gene is required for certain types of HIV to enter into and infect T-cells. T cells     are one of the white blood cells used by the body to fight HIV. The most important of these     are called CD4+ T-cells      Some people are born without the CCR5 gene on their T-Cells. These people remain healthy and     are resistant to infection with HIV. Other people have a low number of CCR5 genes on their     T-cells and their HIV disease is less severe and is slower to cause disease (AIDS).      The purpose of this research study is to find out whether SB-728-T is safe to give to humans     and find out how this affects HIV.   "
155185|NCT01252628|"     The purpose of this Phase 1/2 open-label study is to determine the safety and efficacy of a     cetuximab and PX-866 combination treatment. In the Phase 1 part of the study, the dose of     PX-866 to be given in combination with cetuximab will be determined in patients with     incurable metastatic CRC or incurable progressive, recurrent or metastatic SCCHN. The Phase 2     part of the study is a randomized evaluation of the antitumor activity and safety of PX-866     in combination with cetuximab versus cetuximab alone in patients with either incurable     metastatic CRC who have a history of progression or recurrence following prior irinotecan and     oxaliplatin containing regimens or are intolerant of irinotecan (Group 1) or incurable     progressive, recurrent or metastatic SCCHN (Group 2).   "
155186|NCT01252615|"     The goal of this study is to compare a patient only to a patient+partner intervention on     recovery outcomes of patients and partners after Implantable Cardioverter Defibrillator (ICD)     implantation.   "
155187|NCT01252602|"     The purpose of this prospective cohort study is to search for a relationship between maternal     depression in the third trimester, as indicated by a score of > 12 on the EPDS, and a choice     not to breastfeed at all, defined as no breastfeeding after dismissal from the hospital. The     investigators hypothesize that women who screen positive for prenatal depression will be     significantly less likely to breastfeed their babies after discharge from the hospital     following childbirth.   "
155212|NCT01252277|"     This study is designed to gather information on how the prescription drug Lovaza™ which     contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer.     This drug is currently approved by the FDA for reducing blood levels of triglycerides.   "
155188|NCT01252589|"     Although the impact of disease and treatment related burden on health-related quality of life     (HRQOL) in patients with solid tumours has been well studied, with several clinical trials     that included HRQOL as an endpoint, the general understanding in patients with Chronic     Myeloid Leukaemia (CML) is lacking in comparison.      The literature shows that patients' perspective is unique and should always be measured with     methodologically sound instruments that are devised for this purpose.      The main scope of this project is develop to an international validated questionnaire for the     purpose of HRQOL assessment; such a tool will then be used to provide important data, from     the patients' perspective, to make more informed treatment decisions.   "
155189|NCT01252576|"     300 italian women will be enroll for linguistic and cultural validation in italian of Female     sexual function index (FSFI). This questionnaire is used in most countries to investigate     female sexual function. To date there are not validate questionnaires in italian on female     sexual function. We decided to start the validation process to give a validated tool to     italian investigators.   "
155190|NCT01252563|"     In this survey, to collect the safety and efficacy information in the subjects who have been     treated with amlodipine 5mg at least 4 weeks in daily practice.   "
155191|NCT01252550|"     The purpose of this study is to investigate the association between gut microbiota,     immunology and typical pathophysiological factors in patients with IBS (all subtypes) AND to     assess the effect of Activia consumption on GI symptoms provoked by a lactulose challenge     test in IBS patients.   "
155192|NCT01252537|"     Background: Tuberculosis (TB) and HIV are leading causes of disease and death in Subsaharan     Africa. Antiretroviral therapy (ART) dramatically improves prognosis in HIV infection, but TB     is still a common complication in HIV-infected subjects. Management of TB-HIV co-infection is     complex, both with regard to diagnosis and treatment. Since scaling-up of ART requires     management of most patients in primary health care, it is critical to achieve better     strategies for TB-HIV co-infection at peripheral levels of the health care system in endemic     regions. This includes development of new methods to assess the severity of HIV disease and     the need to start ART during TB treatment in this population.      Aims: To compare a scoring system for clinical signs of immunosuppression with CD4 cell     counts to assess HIV disease severity and indications for ART initiation, and to correlate     immunosuppression status with treatment outcome.      Workplan: CD4 cell levels and results of clinical scoring has been compared in 1100 patients     with TB, using HIV-negative subjects with TB treatment for control. Inclusion was closed in     February 2012, and follow-up of participants completed in August 2012. Plasma levels of     immune activation and inflammatory markers will be correlated with the degree of     immunosuppression.      Significance: TB is the most significant clinical challenge to the successful scaling-up of     ART in Africa. In order to improve management in primary health care it is necessary to find     robust and reliable techniques for determining disease severity and identification of     patients who need to start ART during TB treatment. This study may contribute to increased     knowledge in this field and help to modify guidelines for management of TB-HIV co-infection     in Ethiopia as well as in other resource-limited settings.   "
155193|NCT01252524|"     The purpose of this study is to determine whether a form of fiber if effective in improving     the treatment of type 2 diabetes. Measurements of other possible medical benefits will     include blood pressure, cholesterol, weight, and the number/dosage of medications used for     diabetes, hypertension, and high cholesterol.   "
155194|NCT01252511|"     The purpose of this study is to determine whether or not the length of the biliopancreatic     limb of the Roux-en-Y anastamosis plays a critical role in the development of malabsorption     after gastric bypass for treatment of severe obesity.   "
155195|NCT01252498|"     This study will evaluate the role of cyclooxygenase pathways in radiation-induced and     chemoradiation-induced mucositis.   "
155196|NCT01252485|"     This is a registry study in adult patients with newly diagnosed or refractory/relapsed     myeloid neoplasms      Investigator's sites: 60-70 sites in Germany and Austria      Estimated duration of observation of an individual patient:      10 years maximum      Objectives        -  To register all patients with acute myeloid leukemia and related precursor neoplasms,          acute leukemia of unambiguous lineage, with higher risk myelodysplastic syndromes (MDS          with excess blasts 2), and with myeloid neoplasms with germline predisposition, newly          diagnosed or relapsed/refractory in all participating centers (completeness)        -  To perform timely analyses of disease-related genetic markers (incidences, treatment          recommendations)        -  To assess patient and family history, clinical characteristics and outcome data          (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence          of death [CID], overall survival [OS])        -  To assess biological disease features and correlate with clinical outcome data          (prognostic and predictive markers)        -  To store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue,          e.g., skin biopsy, buccal swap, finger nails, hairs, or sputum)        -  To assess quality of life   "
155197|NCT01252472|"     Some men who have a history of use of Tamsulosin (Flomax) are at risk for a condition called     Intraoperative Floppy Iris Syndrome that can develop during otherwise routine cataract     surgery. It is not fully understood why this condition develops or who is at risk for     developing it. In this study the investigators will take pictures of the iris and iris blood     vessels before cataract surgery. The investigators hope that the results of this study will     provide a better understanding of how Intraoperative Floppy Iris Syndrome develops and give     us a non-surgical way of figuring out who might develop this problem during surgery.   "
155198|NCT01252459|"     This study is designed to evaluate the impact of radiotherapy target volume delineation based     on AA-PET compared to target volume delineation based on contrast enhanced T1 weighted MRI     (T1Gd-MRI) on the clinical outcome of patients with recurrent glioblastoma (GBM) as well as     concerning therapeutic safety of the respective strategy.   "
155199|NCT01252446|"     This article reviews social-demographic variables (SDV) including interpersonal and academic     and social performance in families and comorbid conditions(CC) which are the most associated     with Attention-Deficit/Hyperactivity Disorder (ADHD)in the sample that has been confirmed     diagnosis of ADHD and sample with the same symptoms but not confirmed diagnosis of ADHD.      There are no reports of this kind in the Norwegian population with ADHD.   "
171095|NCT00070876|"     This study will provide psychosocial training to general health care providers to help them     provide better care to children with mental health problems.   "
155203|NCT01252394|"     The study aims to investigate the correspondence between changes in central venous oxygen     saturation (ScO2) and in cardiac output during hemodialysis. In 12 hemodialysis patients with     an A-V fistula, a thoracic bioimpedance cardiograph will be validated for cardiac output     measurements during ongoing hemodialysis. Provided this validation is satisfactory, impedance     cardiography cardiac output and ScO2 will be measured at intervals during hemodialysis in 25     hemodialysis patients with a central vascular access. Absolute values and trends will be     compared.   "
155204|NCT01252381|"     The aim is to investigate the importance of vitamin D levels to achieve the effect of     strength training. If we can show that vitamin D has an effect of training, the ultimate goal     is to find out why and how vitamin D affects muscle.      This would potentially have important implications for public health. Since a large number of     populations, including elderly, are shown to have too little vitamin D and also has low     muscle strength, it will be essential that these people added vitamin D in relation to     training and rehabilitation.   "
155248|NCT01251809|"     This is an assessment of efficacy and safety of three different doses of pegylated     recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults     with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for     determining specific asparaginase doses to yield various durations of L-asparagine (ASN)     depletion which are required within different treatment phases of ALL therapy.   "
155205|NCT01252368|"     Aim of this trial is to investigate the expression and localisation of different amino acid     transporters and their regulatory proteins derived from the regulatory proteins of the local     renin angiotensin system (RAS) in the intestine. This is investigated on one hand in patients     who do not take any drugs interfering with RAS. On the other hand expression analysis is done     in patients taking daily RAS-active drugs, like ACE inhibitors or sartanes.      After obtaining informed consent of patients attending the hospital for clarification of     gastrointestinal symptoms by gastroduodenoscopy or colonoscopy, 2 biopsies (in addition to     biopsies needed for clinical diagnostics) will be taken from each duodenum, jejunum, ileum     and descending colon.      Biopsies are investigated anonymously at the Institute of Physiology of the University of     Zurich. The mRNA content of amino acid transporters and regulatory proteins, respectively, in     the biopsies is analyzed by quantitative PCR. Transport proteins are in addition analyzed     with immunohistochemistry.      Furthermore amino acid concentration in plasma and urine samples are analyzed by HPLC. From     plasma and serum samples RAS parameters like renin, aldosterone, ACE and angiotensin(1-7) are     measured.   "
155206|NCT01252355|"     The primary objective was to demonstrate the effect of teriflunomide, in comparison to     placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of     MS who are treated with Interferon-beta (IFN-beta).      The secondary objectives were:        -  Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on:             -  Disease activity as measured by brain Magnetic Resonance Imaging (MRI)             -  Disability progression             -  Burden of disease and disease progression as measured by brain MRI        -  Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy        -  Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta          therapy        -  Assess associations between variations in genes and clinical outcomes (safety and          efficacy)        -  Assess other measures of efficacy of teriflunomide such as fatigue and health-related          quality of life        -  Assess measures of health economics (hospitalization due to relapse, including the          length of stay and any admission to intensive care unit)   "
155207|NCT01252342|"     Oxytocin use has become routine practice in elective cesarean delivery to promote uterine     contraction and reduce blood loss. However, there is a lack of consensus regarding the best     dose of oxytocin and the most effective route of administration. Most dosage and delivery     systems have been empirically derived.      It is currently our practice at the Royal University Hospital to start an oxytocin infusion     (20U/L) once the baby has been delivered. Some anesthesiologists use bolus intravenous     oxytocin and it is occasionally requested by the obstetrician. A few obstetricians also     choose to inject bolus oxytocin directly into the uterus (intramyometrial).      The primary objectives of the study include:        1. Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to          prevent need for additional uterotonics, including additional oxytocin;        2. Determine if the addition of prophylactic intramyometrial oxytocin improves both the          primary outcome (uterine tone) and secondary outcomes (estimated blood loss,          preoperative to postoperative change in hematocrit, need for additional uterotonics, and          need for blood pressure support); and        3. Act as a dose finding study to determine if the intramyometrial dose is sufficient to          augment uterine contraction.      The working hypothesis is that the use of intramyometrial oxytocin will not improve primary     or secondary outcomes compared to the current practice of an oxytocin infusion alone.   "
155208|NCT01252329|"     This study will evaluate if there is a difference in survival between elective treatment of     draining lymph nodes vs. clinical nodal observation in patients undergoing Mohs surgery for     high risk skin squamous cell carcinoma of the head and neck who have a normal lymph node     exam. Each treatment arm is accepted as a current standard of care, and the objective is to     compare outcomes between the two arms.   "
155209|NCT01252316|"     Each year in the United States, 300,000 people suffer from Cardiac Arrest (CA), and of them     there is a 90% mortality rate. Out-of-Hospital arrests in particular have a 1-5% survival to     hospital discharge. High quality CPR is crucial to lowering the mortality rate and increasing     survival, yet only 15-30% of out-of-hospital CA victims receive bystander CPR. Studies have     shown that prompt administration of CPR dramatically improves outcomes. In a recent study     from Switzerland, lay bystander CPR doubled the survival rate at one month. Our study will     look to train family members of at-risk cardiac patients in the skills of CPR through the     American Heart Associations (AHA) CPR Anytime Friends and Family Personal Learning Program     (CPR Anytime) to see if these family members are able to learn and perform quality CPR in the     event that their family member should suffer a cardiac arrest. The unique feature of the CPR     Anytime training is that it is a low-cost, self-learning, video-based program that can be     completed in under 30 minutes, saving the time and expense of traditional CPR training     courses. While initial work has proven that teaching CPR in hospital using the VSI kit is     feasible, little research has been conducted to make the program sustainable.   "
155210|NCT01252303|"     The study is to determine the effect of a behavioral weight loss program supplemented with     Nutrisystem meal replacements on weight, blood pressure, fasting blood glucose, and blood     lipids levels over 12 weeks.   "
155211|NCT01252290|"     This study is designed to gather information on how the prescription drug Lovaza™ which     contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer.     This drug is currently approved by the FDA for reducing blood levels of triglycerides.   "
155213|NCT01252264|"     The purpose of this study is to find out if there are any genetic differences between people     with and without disorders of the head, face, and eye. We will create a biorepository of     samples from people with and without these types of birth defects. A biorepository is a     collection or bank of human tissue materials (such as blood or saliva) for research     purposes. These samples will then be available to investigators studying these disorders.   "
155214|NCT01252251|"     The purpose of this study is to find out what effects, good and/or bad, the drugs everolimus     and pasireotide have on the patient and on melanoma. Pasireotide is also called SOM-230.     Pasireotide is an experimental drug and is not approved by the Food and Drug Administration.     Everolimus is also called RAD001. Everolimus is approved for use in the U.S. for kidney     cancer. Everolimus is not approved for treatment of melanomas, but early studies show that it     may help some patients with melanoma.   "
195992|NCT00405080|"     This study will examine what the body does while taking GW679769 alone and together with     rifampin in healthy adult subjects.   "
155215|NCT01252238|"     This study is an investigation of the effect of commonly prescribed anti-hypertensive agents     on insulin sensitivity, diastolic function and aortic compliance. The aims of the study are     as follows:      Specific Aim 1: To determine in insulin resistant, hypertensive subjects if renin inhibition     for 12 weeks modifies glucose homeostasis and insulin sensitivity.      To accomplish this specific aim, we will use three approaches: a fasting HOMA Index; and a     three hour glucose tolerance test. Only hypertensive subjects with insulin resistance, as     assessed by HOMA index will be enrolled in the study. Insulin resistance will be assessed     basally and after twelve weeks of treatment with either a calcium channel blocker with     placebo, or calcium channel blocker with a renin inhibitor, or a calcium channel blocker with     a renin inhibitor and an angiotensin receptor antagonist.      Specific Aim 2: To determine in insulin resistant, hypertensive subjects if renin inhibition     for 12 weeks modifies diastolic function and aortic compliance response to dietary sodium     intake.      The same protocol and subjects will be used as defined in Specific Aim 1. Myocardial     relaxation velocity (tissue Doppler imaging at the mitral annulus) and aortic compliance     (characteristic aortic impedance) will be measured at baseline and then after acute and     chronic renin inhibition:        1. Acute effect of renin inhibition: Hemodynamic measurements will be obtained on both high          and low dietary sodium intake conditions (~1 week each) before and after a single dose          of a renin inhibitor.        2. Chronic effect of renin inhibition: Hemodynamic measurements will be obtained at          baseline and after 12 weeks of each of the three drug treatment arms above.      The study lasts 12 weeks and plans to study 45 hypertensive adults over the next two years.   "
155216|NCT01252225|"     People cough in order to clear their airways. Most coughs are caused by viruses and settle     down by themselves, but some people develop persistent coughing which can be anywhere from 8     weeks to several years. This is called chronic cough. People with chronic cough find the     symptom distressing and it can have a major impact on their quality of life. Patients with     chronic cough often report a sensation at the back of their throat which makes them feel an     urge to cough. There is some evidence that Lidocaine (an anaesthetic used during medical     procedures) can suppress a person's cough when given to patients via a nebuliser (a machine     that turns liquid into a fine mist).      It is currently unknown whether using a local anaesthetic, such as Lidocaine, in the form of     a throat spray would successfully suppress a person's cough. A throat spray would be an     easier treatment option in chronic cough patients. Thus, the investigators research aims to     compare cough rates, severity and urge to cough scores between Lidocaine throat spray and     nebulised Lidocaine.   "
155217|NCT01252212|"     In this project, we will work directly with underserved patients in a safety-net setting to     conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel     adherence intervention embedded in an existing PHR that uses cellular phone short message     service (SMS) reminders and patient responses to the reminders. We will compare adherence     rates in both arms as assessed by antiretroviral medication concentrations in hair samples     and self-report; clinical outcomes will also be compared in the two arms. The project will     examine medication adherence for antiretroviral medications and treatments of common     conditions such as depression, hypertension, diabetes and hypercholesterolemia.   "
155218|NCT01252199|"     This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered     concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB)     Infection.   "
155219|NCT01252186|"     This study is being conducted to evaluate the impact of a 91-day extended cycle oral     contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in     healthy women.   "
155220|NCT01252173|"     The purpose of this research is to measure the endotracheal tube cuff pressure in patients     who have been endotracheally intubated emergently in the emergency department or in the field     by prehospital personnel. Overinflation of ETTc pressure is associated with injury, and we     seek to determine if the phenomenon of excessively inflated ETTc can be detected in     endotracheally intubated patients in the ED.      There is no experimental aspect to this study, it is only descriptive. Measurement of ETTc     pressure is already performed by respiratory therapy/respiratory care. We simply seek to     assess these measurements to determine if any patients in fact have high ETTc pressure. If it     is found that patients do have ETTc with high pressures, this might allow emergency     department staff or prehospital personnel such as paramedics or EMTs to use this information     to seek methods by which endotracheal intubation can be improved and patients can be     intubated without excessive ETTc pressure.      This is a pilot study. We have conducted several in vitro studies, which have all     demonstrated that paramedics, EMTs, and emergency department physicians practice endotracheal     intubation in a method that might result in excessively inflated ETTc.   "
155221|NCT01252160|"     In this study all patients will be treated with the same medicine, the QUTENZA patch.     Subjects will receive up to 6 QUTENZA patch applications over 12 months.   "
155222|NCT01252147|"     This study will evaluate the inter-rater and intra-rater reliability of the Global Eyelash     Assessment (GEA) scale with photonumeric guide in Japanese subjects.   "
155223|NCT01252134|"     The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone     hydrogel (SiH) contact lens with three marketed contact lens care solutions.   "
155224|NCT01252121|"     The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared     to Hialid and saline.   "
155247|NCT01251822|"     This study is to compare the efficacy and safety of polyethylene glycol (PEG) 3350 with that     of prucalopride in the treatment of chronic constipation in females. A total of 240 patients     will be randomly allocated to treatment with one or the other agent. The study consists of a     14-day run-in period, with treatment subsequently administered for 28 days on a daily basis.     During the study, patients will fill in a stool diary, samples of faeces will be collected,     and colonic transit time will be measured prior to therapy, and from days 22 to 28 of     treatment. The proportion of patients with normalised bowel movements (three or more     spontaneous movements) during the last week of the study (days 22 to 28 of treatment) will be     compared between treatments.   "
155264|NCT01251601|"     The purpose of this study is to determine whether pregnancy affects the blood concentrations     of raltegravir by comparing the second trimester and third trimester drug concentrations with     post partum.   "
201766|NCT00481988|"     The purpose of this study is to see if transcranial direct current stimulation may improve     the symptoms of depression.   "
155225|NCT01252108|"     Helicobacter pylori infection of the gastric epithelium is the most common bacterial     infection worldwide. Its global prevalence is estimated at 50%, though the burden falls     disproportionately on the developing world, where the prevalence in some areas is 80%. H.     pylori infection is generally acquired during childhood, and without specific antibiotic     treatment can persist for life. The infection is generally clinically asymptomatic during     childhood, and even in adulthood 80-90% of infected individuals will remain asymptomatic     (although they may transmit the bacteria).      SQ109 is a new, small molecule antibiotic with characteristics that make it particularly     attractive to evaluate against H. pylori. In brief, SQ109 is orally bioavailable,     acid-stable, has in vitro activity against H. pylori and achieves high intracellular     concentration (which may be important to effect bacterial eradication).      Based on the antimicrobial activity and clinical safety, SQ109 will be evaluated in this     clinical trial to assess safety and antimicrobial activity in adults infected with H. pylori.     Data from this study will help determine whether larger safety and efficacy studies in     individuals with H. pylori-associated duodenal ulcer disease are warranted.   "
155226|NCT01252095|"     This first-in-human study aims to establish the maximum tolerated dose of PG545 and to     evaluate its safety in subjects with advanced solid tumours. In addition the study will     explore whether PG545 exposure results in changes to chemicals produced by the body that are     associated with cancer growth and spread.   "
155227|NCT01252082|"     The purpose of this study is to determine whether nonsurgical periodontal therapy is     effective in the metabolic control of patients with type II Diabetes mellitus.   "
155228|NCT01252069|"     This is the long-term extension of a phase III, efficacy and safety open-label (protocol     PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the     administration of progestin or placebo tablets after end of PGL4001 treatment.      This extension study consists of three periods of 3 months open-label PGL4001 treatment, each     followed by ten days of double-blind treatment with progestin or placebo and then a period     without treatment.   "
155229|NCT01252056|"     The efficacy and safety of Cilostazol and Probucol in combination on patients with diabetic     nephropathy is better than the single use.   "
155230|NCT01252043|"     The investigators will try to predict the risk of esophageal varices (EVs) in long-term BA     survivors using noninvasive computed tomography (CT) or magnetic resonance (MR) indices and     the measurement of transverse diameters of paraesophageal and gastroesophageal veins.   "
155231|NCT01252030|"     In this study, 80 coronary artery disease patients with successful coronary revascularisation     (by CABG or PCI) will be included. Patients are excluded in case of: congestive heart     failure, ICD or pacemaker, any disability limiting exercise participation.      These patients are attending phase 2-3 cardiac rehabilitation, and have completed 6 weeks of     rehabilitation. Next, subjects are randomly assigned to a control group or an intervention     group.      Outcome parameters: physical activity, exercise capacity, blood glucose, insulin level and     lipid profile, body weight and waist circumference, cardiovascular morbidity and mortality.      Hypothesis: telemonitoring of physical activity will increase physical activity, and improve     cardiovascular disease risk factors, in CAD patients attending phase 2-3 cardiac     rehabilitation.   "
155232|NCT01252017|"     The purpose of this study is to determine whether nilotinib is effective in the prophylaxis     and treatment of CMV reactivation in allo-HSCT patients.   "
155233|NCT01252004|"     Tako Tsubo syndrome (TTS) is characterized by the occurrence in the context of mental or     physical stress, a clinical and ECG of acute myocardial infarction without significant     coronary artery stenosis, accompanied by a disorder Acute, reversible left ventricular who     takes on a characteristic apical ballonnisation evoking the image of a Japanese octopus trap     called Tako (octopus) tsubo (jar). Pathophysiology of unknown changes immediate     life-threatening prognosis is often good in the longer term.   "
155234|NCT01251991|"     Despite improved treatment, cardiovascular disease remains one of the most common diseases     and causes of death in the Western world. Hypercholesterolemia is a well known risk factor     for developing cardiovascular disease. Prevention and treatment are based in part on lowering     LDL cholesterol. Dietary and lifestyle changes always play an important part of the treatment     and preventive effort, and conversion to a heart-healthy diet reduces LDL cholesterol by a     mean 10%. Further lowering of LDL cholesterol by means of food supplements have been     demonstrated in numerous studies. Cholesterol lowering food supplements include isolated soy     protein and water soluble dietary fibre such as psyllium husks. Postulated mechanisms of     action responsible for the cholesterol lowering in these two food supplements are different,     so there is a reason to expect an additive cholesterol lowering effect during concomitant     treatment with both substances. The investigators want to investigate whether concomitant     treatment with psyllium husks and isolated soy protein in addition to a heart-healthy diet     results in a significantly greater reduction of LDL cholesterol in hypercholesterolemia, than     single treatment with each of the substances.   "
155235|NCT01251978|"     Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients     with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help     reduce the number of laser treatments that might be needed to control the tumor.   "
155236|NCT01251965|"     The goal of this clinical research study is to find the highest tolerable dose of ruxolitinib     that can be given to patients with acute leukemia and to learn if the study drug can help     control the disease. The safety of the drug will also be studied.   "
155237|NCT01251952|"     The primary goal of this study is to determine the feasibility and safety of giving two doses     of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a     dose escalation fashion. Secondary goals include evaluating the the effect of DD on the     number and percentage of T-regs in the peripheral blood post transplant at each dose level,     the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and     determining the time to engraftment: absolute neutrophil count (>0.5 x 10^9/L for 3     consecutive days), and platelet (>20X 10^9/L for 3 consecutive days).      The hypothesis for the study is based on the ability of DD to deplete T-regs and subsequently     enhance the immune reconstitution and reverse post transplant lymphopenia. This may     indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.   "
169123|NCT00051766|"     The purpose of this study is to evaluate the effectiveness of a computer-assisted,     self-administered adherence program for patients on complicated anti-HIV drug regimens.   "
155239|NCT01251926|"     Background:      - The anticancer drug bevacizumab works by reducing the formation of new blood vessels in     tumors, which can slow or stop the growth of cancer cells and supporting blood vessels. The     experimental drug EZN-2208 works by limiting how well cancer cells can divide. Drugs similar     to EZN-2208 also work by turning off the production of the HIF protein, which otherwise can     help cancer cells to grow even when blood supply is limited. Researchers are interested in     determining if EZN-2208 turns off HIF in patient tumors, and whether combining it with     bevacizumab is an effective treatment for cancers that have not responded to standard     treatment.      Objectives:      - To assess the safety and effectiveness of the combination of EZN-2208 and bevacizumab for     solid tumors that have not responded to standard treatment.      Eligibility:      - Individuals at least 18 years of age who have solid tumors that have not responded to     standard treatment.      Design:        -  Participants will be screened with a full physical examination and medical history,          blood and urine samples, and tumor imaging studies.        -  Participants will receive EZN-2208 and bevacizumab intravenously on an outpatient basis          in 4-week cycles (with the exception of the first cycle, which will be 5 weeks).        -  Cycle 1: Participants will receive EZN-2208 once a week for 3 weeks in a row (days 1, 8,          and 15), followed by 1 week without the drug. Participants will receive bevacizumab 1          week before EZN-2208 (day - 7) and then 3 weeks later (day 15).        -  Subsequent cycles: Participants will receive EZN-2208 once a week for 3 weeks in a row          (days 1, 8, and 15), followed by 1 week without the drug. Participants will receive          bevacizumab every 2 weeks (days 1 and 15).        -  Participants will have clinic visits with physical examinations and blood tests in the          first 3 weeks of each cycle. Clinic visits may also include tumor imaging studies and          tumor biopsies as directed by the study researchers.        -  Participants will continue to take the study drugs for as long as the tumor shrinks or          does not grow, and as long as they do not experience intolerable or unsafe side effects          from the drugs....   "
155240|NCT01251913|"     Background:      - An important new area of brain tumor research is the development of tumor and brain stem     cell lines. Successful growth of these cell lines requires obtaining large volumes of fresh     tumor and brain tissue, which is best accomplished by harvesting whole brains from recently     deceased patients. These cell lines will help researchers understand how these tumors develop     and will also help identify new targets for treatment. Researchers are interested in     conducting a pilot study of planned inpatient hospice care with timely brain tumor tissue     harvest at the time of death.      Objectives:        -  To provide high-quality end of life inpatient hospice care for patients with untreatable          brain tumors.        -  To procure brain and tumor tissue shortly after time of death in order to derive viable          tumor and neural stem cell lines for research purposes.      Eligibility:        -  Individuals at least 18 years of age who have an untreatable primary brain or central          nervous system tumor, are able to give informed consent (either their own or through a          designated power of attorney), and have agreed to a Do Not Resuscitate order and Consent          for Autopsy as part of the end-of-life care plan.        -  HIV-positive individuals or those suspected of having infectious cerebritis are not          eligible because of the potential for contamination of brain tissue.      Design:        -  Participants will be enrolled in inpatient hospice admission to the National Institutes          of Health Clinical Center either from home or from an outside hospital once a study          investigator estimates an expected survival of less than 2 weeks.        -  Participants will receive palliative care at the Clinical Center. Care will be tailored          to each participant depending on the information provided in the individual's          end-of-life care plan.        -  Supportive medications such as antiseizure medications and pain relievers will be          administered as appropriate.        -  At the time of death, researchers will follow standard procedures for notifying next of          kin and will collect brain tissue and tumor samples from the deceased.        -  Following tissue collection, the deceased will be released for autopsy and funeral          procedures.   "
155241|NCT01251900|"     Background:      - BRCA1 and BRCA2 gene mutations have been linked to a higher risk of developing breast     cancer and other cancers, and may be associated with types of breast cancer that are more     difficult to treat and more likely to recur. New cancer treatments are being developed     specifically to treat individuals who have these gene mutations. However, more information is     needed about the prevalence of these mutations in minority populations, including     Hispanic/Latino populations. To study these populations, researchers are interested in     collecting genetic material (DNA) and medical history information from Hispanic/Latino women     who have been diagnosed with breast cancer.      Objectives:      - To collect saliva samples and medical and family history information from Hispanic/Latino     women with breast cancer.      Eligibility:      - Hispanic/Latino women at least 18 years of age who have been diagnosed with breast cancer.      Design:        -  Participants will complete a questionnaire with information about place of birth,          languages spoken by parents and grandparents, and information about their breast cancer          diagnosis.        -  Participants will provide a saliva sample (2 to 3 tablespoons) for analysis.        -  No treatment will be provided as part of this protocol.   "
155242|NCT01251887|"     Background:      - Rates of obesity have increased dramatically in recent decades, and researchers are     investigating how changes in diets and physical activity have contributed to this increase.     To understand how weight might be controlled, it is important to learn what kinds of dietary     changes can affect hunger and might lower body weight. Essential fatty acids, for instance,     are an important part of a healthy diet, but researchers have not yet determined the ideal     amount of essential fatty acids that people should eat. By studying how different diets     affect body chemistry and hormone levels in women who are overweight or obese, researchers     hope to be able to determine better diets or treatments to help people reach and maintain an     optimum healthy weight.      Objectives:      - To examine how certain fats in the diet affect body metabolism, hormones, and weight     regulation.      Eligibility:      - Healthy women between 18 and 50 years of age who are overweight or obese (body mass index     between 25 and 35).      Design:        -  This study has an initial screening visit and three phases. All participants will be          involved in the first two phases of the study, and some participants will be involved in          the third phase.        -  Participants will be screened with a physical examination and medical history, in          addition to blood and urine tests and questionnaires about eating habits and other diet          factors.        -  Phase 1: Participants will have three visits to the National Institutes of Health over a          4-week period. At the visits, participants will have blood and urine tests, complete          questionnaires, and have other tests including brain and body imaging studies.          Participants will then be assigned to one of three study diets.        -  Phase 2: Participants will have a 12-week diet phase, with all foods supplied by the          study researchers. Participants will keep a daily log of food and beverage intake, and          will have three testing sessions with procedures similar to those performed in Phase 1.        -  Phase 3: Participants assigned to a particular study diet (one-third of all          participants) will be given the option of continuing the diet for an additional 36 weeks          (9 months), with food consumption, monitoring, and testing procedures similar to those          performed in Phase 2....   "
155243|NCT01251874|"     This phase I trial studies the side effects and best dose of veliparib when given together     with carboplatin and to see how well they work in treating patients with human epidermal     growth factor 2 (HER2)-negative breast cancer that has spread to other parts of the body.     Carboplatin kills cancer cells by damaging the deoxyribonucleic acid (DNA) that lets the     cancer cell survive and reproduce. The body has proteins that try to repair the damaged DNA.     Veliparib may prevent these proteins from repairing the DNA so that carboplatin may be able     to kill more tumor cells. Giving veliparib with carboplatin may kill more tumor cells than     carboplatin alone.   "
155244|NCT01251861|"     This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206     works in treating patients with previously treated prostate cancer. Androgens can cause the     growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the     amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. It is not yet known whether     bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate     cancer.   "
155245|NCT01251848|"     The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each     other when coadministered.   "
155246|NCT01251835|"     This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of     sitaxsentan given alone and with rifampin will also be assessed.   "
155265|NCT01251588|"     To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic     microfracture, in participants who received study treatment in the SUMMIT study for treatment     of symptomatic articular cartilage defects of the knee.   "
155249|NCT01251796|"     This is a phase I study to determine the safety, tolerability and recommended phase II dose     of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor     metabolizer patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic     profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib     will also be determined as secondary endpoints.   "
155250|NCT01251783|"     Objectives: To evaluate the safety; efficacy; bone mineral metabolism & immunity changes of     the use of Metlin & Metlos added to the Infant Formula Study Design: Randomized, double     blind, clinical, controlled trial, in 600 full-term infants of 15 ± 7 days randomized to     recive formula with probiotics + Metlin + Metlos; formula with probiotics + Metlin; Formula     with probiotics + Metlos; formula only with probiotics or formula without probiotics and     prebiotics; having a totally breast feed group as control.). Outcomes variables were     frequency of stools; bowel intolerance manifestations (abdominal distension, flatulency,     regurgitations, vomiting); report of dermatological problems like eczema; changes on the     intestinal microbiota; lipids profile (cholesterol, triglycerides, lipoproteins associated to     cholesterol); anthropomorphic profile and somatic growth ( weight gain, stature, arm mean     circumference, skin folds); bone mineral metabolism (high-speed bone ultrasonography); and     changes in the immunity (changes in the concentrations of salivary IgA and the frequency of     respiratory events suggestive of infection)]. Statistical analysis was made with STATA Ver.     11.0 for Mac. Safety and efficacy variables, were compared by Chi squared in the case of     categorical variables or by ANOVA or Kruskall Wallis for the numeric variables. When     convenient, a covariates adjustment was done by ANOVA or by multiple lineal regressions for     continuous numerical outcomes or logistic regression for categoric outcomes. In all the     hypothesis tests the p significant value of <0.05 were used.   "
155251|NCT01251770|"     The primary objective of this study is to compare the blood sodium level after 12 hours     following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose     5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.   "
155252|NCT01251757|"     The purpose of this randomized clinical trial is to determine whether two low-intensity,     technology based interventions, when compared to each other and to usual care, improve     adherence to selected medications that are used to treat people with cardiovascular disease     (CVD) and diabetes.   "
155253|NCT01251744|"     This study is designed to evaluate maternal virological and immunological parameters to     determine their ability to predict congenital cytomegalovirus (CMV) infection. When a     pregnant woman is infected with CMV, her immune system (which protects her from infection) is     activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine,     vaginal secretions). The aim of this study is to find out if there is a link between either     the pregnant woman's immune response or the presence of the virus in these bodily fluids and     the child/foetus being infected with the virus.   "
155254|NCT01251731|"     The purpose of this study is to evaluate the single-dose (SD) pharmacokinetics (PK),     pharmacodynamics (PD), safety and tolerability of 10, 40, and 80 mg E5501 followed by a     selected dose for multiple dosing (MD) in healthy Japanese, Chinese, and Caucasian subjects.   "
155255|NCT01251718|"     To investigate the clinical safety and effectiveness of donepezil hydrochloride     administration in patients with mild or moderate Alzheimer's Disease   "
155256|NCT01251705|"     Comparison of different methods for measuring peoples corneal thickness   "
155257|NCT01251692|"     To determine the ten-year visual results and outcome of excimer laser phototherapeutic     keratectomy (PTK) for recurrent corneal erosions.   "
155258|NCT01251679|"     The purpose of this study is to determine whether nonpharmaceutical interventions (i.e.,     handwashing and masks) reduce secondary transmission of influenza in households.   "
155259|NCT01251666|"     Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health     priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while     the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless     automated quantitative I-FOBTs have not been compared, and the optimal number of samples and     threshold is not yet fixed. The aim of this study is to compare the performances of the 2     more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by     Eiken) for different positivity thresholds and numbers of samples in general average risk     population. Patients will performed a two samples Magstream, a two samples OC Sensor and     Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and     specificity for detection of cancer and advanced neoplasias will be compared between tests     using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of     samples and positivity threshold.   "
155260|NCT01251653|"     To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in     combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors.      To assess the safety of the combination. To investigate the PK characteristics of docetaxel     or gemcitabine and of oral afatinib (BIBW2992) in the tested treatment schedule. To assess     antitumor activity.   "
155286|NCT01251302|"     To investigate whether the use of a gene expression score blood assay changes the diagnostic     testing pattern in patients referred to a cardiologist for the evaluation of chest pain or     anginal equivalent symptoms.   "
155261|NCT01251640|"     Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus     gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.      Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine     (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.      Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints:     response duration, disease control rate, time to progression, progression-free survival,     overall survival, safety and tolerability.      Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and     weekly throughout the study; Safety follow-up visit 30 days after the last dose of study     treatment; Survival follow up monthly for up to 8 month after LPFV.   "
155262|NCT01251627|"     The study aims to assess the activity of decitabine in the treatment of CMML.   "
155263|NCT01251614|"     This study will compare how well adalimumab works versus methotrexate (MTX) in children with     moderate to severe psoriasis in the short term. It will also study how safe and how well     adalimumab works in the long term and how long disease response can be maintained after     stopping therapy.   "
155266|NCT01251575|"     This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works     in preventing graft-vs-host disease (GVHD) in patients with hematologic malignancies     undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and     total-body irradiation before a donor peripheral blood stem cell transplant helps stop the     growth of cancer cells. It may also stop the patient's immune system from rejecting the     donor's stem cells. When the healthy stem cells from a donor are infused into the patient     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,     and platelets. Sometimes the transplanted cells from a donor can make an immune response     against the body's normal cells. Giving total-body irradiation together with sirolimus,     cyclosporine, and mycophenolate mofetil before and after transplant may stop this from     happening.   "
155267|NCT01251562|"     The primary objective of this clinical study is as follows:      • To determine the MTD and to assess the safety and tolerability of C31510 administered as a     single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors      The secondary objective of this study is as follows:      • To evaluate plasma PK and estimate renal elimination of C31510 administered as a single     4-hour IV infusion (up to nine different dosages) in subjects with solid tumors      The exploratory objectives of this study are as follows:        -  To evaluate the pharmacodynamic correlates of C31510 activity in plasma and peripheral          blood cells        -  To radiographically evaluate the effects of C31510 on tumors. In selected subjects, the          effects on vascular permeability will be assessed by digital contrast enhanced          (DCE)-magnetic resonance imaging (MRI)        -  To evaluate tumor response (preliminary antitumor activity) after repeat administration          of C31510        -  Long-term safety and tolerability of C31510 after repeat administration   "
155268|NCT01251549|"     ReWalk suit developed by Argo Medical Technologies is designed to enable people with lower     limb disabilities to carry out routine ambulatory functions (stand, walk etc.); it can be     used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple     sclerosis, cerebral palsy and other pathologies that produce severe walking impairments.   "
155269|NCT01251536|"     The purposes of this study are to determine whether administering escalating doses of     cetuximab in patients with no early skin toxicity could delay the progression of disease in a     significant proportion of patients and to study the molecular signatures of response.   "
155270|NCT01251523|"     The proposed randomized clinical trial will compare two educational interventions: Physicians     Asthma Care Education (PACE) and PACE Plus with 90 physicians in Atlanta and the Bronx and     their 1192 patients.   "
155271|NCT01251510|"     PURPOSE      The goal of the present project is to unravel the importance of bile acid-induced GLP-1     secretion (via the G protein-coupled receptor TGR5) in human physiology.      In the present study the investigators examine the GLP-1 secretion in healthy subjects and     cholecystectomised patients. Thereby the investigators aim to show, that cholecystectomised     patients have reduced bileflow after a meal, and as a consequence exhibit a diminished GLP-1     response as compared to healthy subjects.   "
155272|NCT01251497|"     The purpose of the study is to evaluate the effectiveness of the íSi, Yo Puedo Controlar Mi     Diabetes! (Yo Puedo) diabetes self-management education program.   "
155273|NCT01251484|"     VEGF inhibition by BEV may induce a change in tumor invasiveness and treatment failure is     often associated with remote metastases. BEV may stop the growth of tumor cells by blocking     blood flow to the tumor. Cediranib, a pan-VEGF inhibitor has shown promising results in     recurrent GBM.      VEGF-blocking with small molecules may overcome the mechanism of resistance, and response to     BIBF-1120 in such circumstances may open a new treatment option in GBM. In additional,     recurrent glioblastomas have an extremely poor prognosis, so innovative therapies are needed.   "
155274|NCT01251471|"     The aim of this pharmaco-MRI study is to investigate neural correlates of variable     antidepressant treatment response driven by genetic variation in multiple genes involved in     depression.      Thirty Major Depressive Disorder (MDD) patients with a concurrent major depressive episode     will undergo three MRI scanning sessions after escitalopram treatment initiation.     Furthermore, extensive behavioral assessments and measures of potential peripheral markers     such lymphocyte mRNA or pharmacological parameters on platelets or lymphocytes will be     performed.      Imaging measures have been suggested to be superior for drug response assessment as compared     to psychometric scales, which hardly correlate with biological parameters. Since imaging     techniques are too expensive and sophisticated for a broad clinical use, this study will     provide pilot data on potential peripheral biomarkers of neural activation being related to     drug response.   "
155275|NCT01251458|"     This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel   "
155276|NCT01251432|"     This research study measures how well the Eustachian tube works and looks directly at the     anatomy of the Eustachian tube in adults who have had tympanostomy tubes surgically inserted     into their eardrums because they have been diagnosed as having either otitis media or poor     Eustachian tube function. The Eustachian tube is a biologic tube that connects the back of     the nose to the middle ear (the airspace located behind your eardrum). That tube is usually     closed, but can be opened by swallowing and other activities. Periodic openings of the     Eustachian tube allow air to flow between the nose and middle ear which keeps the pressure of     gas in the middle ear at the same level as that of the atmosphere, a condition required for     good hearing. In children and adults, middle-ear diseases such as otitis media with effusion     (the buildup of fluid within the middle ear) and a form of temporary hearing loss (conductive     hearing loss) occur if the Eustachian tube does not open, does not open frequently enough or     is always open (called a patulous Eustachian tube). A diagnosis of these different conditions     can be made using standard, clinical tests of Eustachian tube function and the Eustachian     tube can be visualized where it enters the back of the nose using a specialized telescope     called an endoscope. Some scientific reports suggest that the cause of poor Eustachian tube     function in an individual can be determined by studying the anatomy of the Eustachian tube at     the back of the nose and the movements of the Eustachian tube in that area during swallowing,     talking and other activities using an endoscope.      In this study, the investigators plan to explore the relationship between the results of the     standard Eustachian tube function tests and those for the anatomy and function of the     Eustachian tube in adults with a disease condition likely to be caused by poor Eustachian     tube function. Also, there are a number other disease conditions (examples: nasal allergy,     acid reflux disease) that are related to poor Eustachian tube function and it is possible     that these conditions and their effect on Eustachian tube function can be treated with     medicines. Therefore, the investigators also plan to evaluate enrolled persons for those     conditions. It is expected that if the results of the standard Eustachian tube function tests     can be explained by the anatomy of the back of the nose and Eustachian tube, the functional     anatomy (movements during swallowing etc) of the Eustachian tube or the presence of allergy     and or/acid reflux disease, new medical and/or surgical treatments can be developed to     improve Eustachian tube function and cure or treat the associated middle-ear diseases.   "
155277|NCT01251419|"     The goal of this project is to understand the effects of receiving peer information on     individuals' conversion rates from brand name prescription medication to generic prescription     medication.   "
157200|NCT01226095|"     This is a prospective, multi-center, post-marketing observational study to evaluate the     effectiveness and compliance of ibuprofen in a sustained release form in the treatment of     Egyptian osteoarthritic patients.   "
155278|NCT01251406|"     The mortality of chronic heart failure patients remains high. Recombinant human Neuregulin-1     (rhNRG-1, also called Neucardin) is a 61 amino acid peptide that acts directly on damaged     heart muscle cells to restore their structure and function. This study will investigate the     safety and efficacy of rhNRG-1 to treat stable chronic heart failure.   "
155279|NCT01251393|"     Cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15     and 64 years old. The drug dependence has been described by many authors as a dysfunction of     the brain reward system. Considering the effects of the cholinergic system on the drug reward     and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine     dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic     antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. To     accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be     study. This is a double-blind controlled and randomized placebo study. All the patients will     be treated with brief intervention therapy (BIT), and half of them will receive biperiden     (6mg/day) while the other half will receive placebo. The treatment efficacy will be evaluated     through the comparison between the values obtained on the following measures before and after     the treatment: Craving scale of Minnesota and Cocaine/crack consumption questionnaire, and     the presence of the cocaine metabolite (benzoylecgonine) on urine.   "
155280|NCT01251380|"     The purpose of this research study was to determine the long term safety and efficacy of     repeated treatments with Dysport® used in the treatment of lower limb spasticity in children     with dynamic equinus foot deformity due to cerebral palsy.   "
155281|NCT01251367|"     The purpose of this research study is to assess the long term safety of Dysport in     hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over     repeated treatment cycles.   "
155282|NCT01251354|"     The purpose of the protocol is to determine the effect of BN83495 on the progression of     endometrial cancer with estrogen receptor in post menopausal women who had previously     received chemotherapy.   "
155283|NCT01251341|"     The increasingly widespread use of meditation for stress-related emotional and medical     conditions highlights the urgent need to rigorously evaluate mechanisms through which the     benefits of practice might be conferred. Primary challenges in this regard include evaluating     dose response relationships between practice time and outcomes; clarifying whether     physiological and behavioral effects of meditation derive primarily from non-specific aspects     of training or result from specific meditation practices; and identifying molecular     mechanisms by which meditation might affect physiological responses relevant to     stress-related illness. Recent findings from a cross-sectional study by our group indicate     that young adults who are randomized to, and practice, compassion meditation demonstrate     reduced inflammatory responses, less emotional distress, and reduced autonomic responses to a     standardized laboratory psychosocial stressor (Trier Social Stress Test [TSST]) when compared     to subjects randomized to an active control condition. However, as a result of the     cross-sectional study design and lack of a meditation comparator arm, these results provide     only partial insight into key issues outlined above regarding the role played by specific     meditation procedures and/or practice time in observed physiological and behavioral outcomes.     The primary hypothesis of the proposed work is that practicing a meditation procedure     specifically designed to enhance empathic concern for others (i.e. compassion meditation)     will optimize autonomic reactivity to psychosocial stress in a manner that results in     diminished activation of peripheral inflammatory signaling pathways and reduced behavioral     distress.   "
155284|NCT01251328|"     Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are     considered to be too sick for conventional aortic valve replacement. There is no conclusive     opinion about the best anesthesiologic management of these patients. Sedation and general     anaesthesia are both adequate and the current literature shows no benefit towards one of     these methods.      This study wants to investigate the influence of these two anesthesiologic managements on the     cerebral oxygen saturation during the rapid pacing-period during valvuloplasty. The     patients are randomised allocated to one of these two anaesthesiological managements. The     investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen     saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral     hypoxia.   "
155285|NCT01251315|"     Glutathione is a powerful protective substance found within every cell in the body. It has     been shown that glutathione levels go down as a person gets older, which makes a person more     likely to get heart disease, high blood sugar problems and different kind of cancers.     N-Acetyl Cysteine is used as a dietary supplement. It has been reported to increase     glutathione levels in the body. The diet supplement called ProImmune is also changed by the     body into glutathione. Therefore, the purpose of this study is to find out the effect of     ProImmune in healthy people. This study will also help to prove whether or not the ProImmune     is able to improve the blood levels of glutathione in healthy people.   "
155289|NCT01251263|"     This study will examine the combined effects of a continuous oral contraceptive (OC) regimen     with supplemental estradiol therapy on headache severity and occurrence in subjects with     documented Menstrually Associated Migraines (MAMs). The subjects enrolling in the study will     have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal     contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen     following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs,     the subject will institute a 4-day hormone-free interval (HFI). In an attempt to     prevent/lessen the severity of headache during the HFI, subjects will be randomized to oral     estradiol or placebo during this period. If no BTB/BTS occurs after 80 days of continuous     pills, the subject will institute a 4-day HFI during which they will be randomized into     estradiol or placebo groups.      The purpose of this research study is to examine the effects of continuous oral contraceptive     pills and oral estradiol on headaches that occur around the time of your period. Many woman     take continuous oral contraceptive pills (OC) and when OCs are stopped they may get     headaches. This study will examine if taking estradiol around the time of the period will     affect the headache, and how it will be affected.      This study is a prospective trial. A subject's participation will last approximately 32     weeks.   "
155290|NCT01251250|"     RATIONALE: Azadirachta indica may be an effective treatment for chronic lymphocytic leukemia.     PURPOSE: This phase I trial is studying the side effects and best dose of Azadirachta indica     in treating patients with chronic lymphocytic leukemia.   "
155291|NCT01251237|"     It is particularly important that thorough gut cleansing is achieved prior to the colonoscopy     for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E) solutions     are well established as safe and effective agents for gut cleansing and Norgine has     successfully developed a low volume (2 litre) PEG+E gut lavage solution. The efficacy and     safety of this solution is similar to the standard 4 litre PEG+E, but with improved patient     acceptance.      Tolerance, acceptability and satisfaction with the cleansing agent plays an important role in     subjects' compliance with gut preparation procedure. The study medication NRL0706 is     identical to the PEG+E-containing gut lavage solution commonly used in clinical practice,     with the exception that the flavour has been modified from lemon to orange. This study is to     investigate the tolerability, acceptability, safety and efficacy of a single dose of NRL0706     (MOVIPREP Orange) in subjects without gastrointestinal symptoms undergoing colonoscopy for     colon cancer screening.   "
155292|NCT01251224|"     The MAAIT is a randomized, controlled trial of a home intervention to reduce mouse allergen     exposure in mouse allergic children with asthma and mouse allergen exposure. Participants     will be randomized to either the Integrated Pest Management (IPM) Group or the Education     Group. The IPM Group will receive professional mouse abatement, education, two HEPA filters,     allergen-proof mattress and pillow encasements, and targeted cleaning. The Education Group     will receive education about IPM at the beginning of the trial and then after completion of     the trial, will receive the IPM intervention. Participants will be followed for 12 months.   "
155293|NCT01251211|"     Pain due to peripheral nerve lesion remains extremely difficult to treat and current     treatments have onl moderate efficacy and/or side effects. The investigators have previously     demonstrated the long term efficacy of Botulinum toxin type A (BTX-A) in a small group of     patients with post-traumatic/postherpetic neuralgia and allodynia. The present study aims to     a/ confirm the efficacy of repeated applications of BTX-A in a larger group of patients with     peripheral neuropathic pain with or without allodynia(primary outcome) ; b/ evaluate its     mechanisms of action ; c/analyse the predictors of response ;d/analyse whether the second     injection is associated with a therapeutic gain. This will be a randomized placebo controlled     study. A total of 30 patients will be randomized to receive either BTX-A (subcutaneous     injection in the painful area) or placebo. Each injection will be repeated within at least 3     months depending on the duration of efficacy. Skin punch biopsies will be performed before     and 1 month after BTX-A administration. The investigators postulate that this study will     confirm the clinical efficacy and good safety of repeated administrations of BTX-A in the     treatment of peripheral neuropathic pain.   "
155294|NCT01251198|"     Observatory multicenter, prospective, to support the acute phase of acute coronary syndromes     with ST segment elevation ST (myocardial infarction).   "
155295|NCT01251185|"     Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves     for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.   "
155296|NCT01251172|"     This phase II clinical trial is studying how well gamma-secretase/Notch signalling pathway     inhibitor RO4929097 (RO4929097) after autologous stem cell transplant works in treating     patients with multiple myeloma. Giving chemotherapy, such as melphalan, before autologous     stem cell transplant stops the growth of cancer cells by stopping them from dividing or     killing them. Before treatment, stem cells are collected from the patient's blood and stored.     After chemotherapy, the stem cells are returned to the patient to replace the blood-forming     cells that were destroyed by the chemotherapy. RO4929097 may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth. Giving RO4929097 after autologous     stem cell transplant may kill more cancer cells.   "
155297|NCT01251159|"     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This laboratory study is studying bone marrow samples from patients with acute     myeloid leukemia.   "
155298|NCT01251146|"     This is a Phase 4, prospective, multi-centric and randomized controlled study to compare the     effects of bisoprolol and atenolol on resting heart rate (RHR) and sympathetic nervous     system's (SNS) activity in subjects with essential hypertension.   "
155299|NCT01251133|"     This is a multi-center, comparative, two-arm, parallel-group, single-blind, phase III study     to assess immunogenicity and safety of 4th LBVH0101 (Haemophilus influenzae type b tetanus     toxoid conjugate vaccine) vaccination compared with 4th Hiberix™ vaccination after the same     vaccination with primary one in healthy toddlers who completed the primary vaccination with     LBVH0101 or Hiberix™ in LG-VHCL002 study.   "
155310|NCT01250990|"     This study looks at whether niacin improves reverse cholesterol transport (RCT) in healthy     volunteers. 3H-Cholesterol will be used to measure RCT by analyzing changes in the tracer     activity in total plasma, lipoproteins, red blood cells (RBCs) and stool. The hypothesis is     that niacin augments reverse cholesterol transport.   "
155300|NCT01251120|"     This randomized, open-label, parallel-group study will assess the effect on disease remission     of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs     (DMARDs) versus current best practice non-biologic DMARD therapy in patients with     moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the     RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every     4 weeks. The anticipated time on study treatment is 12 months.   "
155301|NCT01251107|"     The choice of a preferred first-line treatment requires balancing the desire for optimal     disease control with the occurrence of early and late treatment-related effects. To fully     assess this balance, the treatment decision process should ideally take into account the     outcome following a consistent second-line therapy, in particular when tolerated, widely     applicable and highly effective salvage regimens exist, like in Hodgkin lymphoma failing     initial chemotherapy.   "
155410|NCT01249664|"     VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to     choroidal neovascularization secondary to pathologic myopia. This will be a     placebo-controlled trial. 3 out of 4 patients will receive an injection of VEGF Trap-Eye into     the affected eye (and repeated injections if required), and 1 out of 4 patients will receive     a sham injection requiring no needle stick, but making the patient unaware of whether or not     he received active treatment.      Outcome of the two treatment groups will be compared after 24 weeks. From week 24, sham     patients may receive active treatment.      Total duration of the study will be 48 weeks.   "
155302|NCT01251094|"     Background      Cognitive impairment in Parkinson's disease (PD) is common, even in the early stage of this     disease.The cumulative prevalence of dementia associated with Parkinson's disease (PDD) is as     high as 80% in a recent 8-year prospective study. However, some kinds of cognitive impairment     are not apparent and the value of self-report cognitive decline became limited. In other     words, some cognitive impairment may be detected by cognitive tests rather than self-report     of the symptoms.The early intervention of the cognitive impairment may be helpful for these     patients. Neuropsychiatric symptoms(NPSs) are also common in PD and PDD patients. The     severity of NPSs contributes to reduced quality of life and distress for caregivers. Previous     studies showed some different clinical phenotypes of NPSs in PD or PDD patients. Among the     NPSs, hallucination was considered a critical factor of cognitive dysfunction in PD and PDD     patients. The co-occurrence of NPSs in PD and PDD patients has limited evidence now.      Purpose      To establish the screening tools for early detecting the PD patient with cognitive     impairment; exam the diagnostic value of MoCA and other cognitive tests in PD with mild     cognitive impairment, possible PDD, and probable PDD; understand neuropsychiatric symptoms     (NPSs) in these different patient groups; exam the relationship between each NPS and each     domain of cognitive dysfunction.      Methods      In order to exam the cognitive dysfunction in PDD (attention, executive function,     visuo-spatial function, and memory), several tests are performed. A 32-item cognitive decline     questionnaire will be used to screen the cognitive impairment in subjects. Mini-Mental state     examination (MMSE) and Montreal cognitive assessment (MoCA)are used for cognitive evaluation.     The detail evaluation of each domain is specified asfollowing: (1) Attention (WAIS-R digit     span), (2) Memory (12-item word recall test),(3) Executive function (category verbal     fluency), (4) Visuospatial function (cube copying and clock drawing). The motor symptoms     severity of the PD will be evaluated by the Hoehn & Yahr stage and motor portion of the     Unified Parkinson's Disease Rating Scale (UPDRS). The neuropsychiatric symptoms will be     recorded by Neuropsychiatric Inventory Questionnaire (NPI-Q). The daily living activity will     beevaluated by modified Lawton's instrumental activities of daily living scale (IADL)and pill     questionnaire. Subjects also receive 15-item Geriatric Depression Scale(GDS-S) to evaluate     the mood status. The clinician's diagnosis of dementia will be based on the diagnostic     criteria of DSM-IV, which will be compared with the PDDdiagnostic criteria proposed by MDS in     2007. The investigators will also try to develop a PDDscreening questionnaire.      Expected results      Cognitive impairment and dementia of PD patients will be ascertained by the cognitive test     battery. The screening questionnaire will be established. The heterogeneity of NPSs in PD and     PDD will be evaluated. The PDD screening questionnaire will help the clinician to diagnose     the patients.   "
155303|NCT01251081|"     In patients with sepsis and AKI, increasing the intensity of renal replacement therapy from     50 mL/kg/h (HVHF) to 85 mL/kg/h (EHVHF)will increase the survival at 28 days and 90 days.   "
155304|NCT01251068|"     Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside     investigation of cerebral oxygenation in newborn infants. Using this technique we     investigated the relationship between changes in cerebral oxygenation and hemodynamics, and     changes in some physiological variables during blood transfusion in anaemic preterm infants.   "
155305|NCT01251055|"     The etiology of schizophrenia remains unclear In recent one decade, hypofunction of     N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of     schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for     schizophrenia treatment.      To date, refractory schizophrenia (particularly clozapine-resistant) is still a difficult     clinical issue. However, the effect of NMDA treatment in refractory schizophrenia is still     unknown. Therefore, the primary goal of this study is to investigate the efficacy and safety     of NMDA adjuvant therapy in refractory schizophrenia, and to identify the predictors for     treatment response to NMDA enhancers.   "
155306|NCT01251042|"     The study is an open, randomized, controlled, single-centre study including a total of 42     evaluable subjects scheduled for spinal surgery with an approximate expected bleeding of     800-1500 ml. The Sangvia® Blood Salvage System will be set up for all subjects to collect     blood intra-operatively. When the transfusion bag is filled, i.e. when around 500 ml of blood     has been collected, the subject will be randomized to either be retransfused with the blood     collected (investigational group) or not (control group). The primary objective for this     study is to investigate the blood quality and isolate the systemic effects in     intra-operatively collected blood. The systemic p-Hb concentration has been chosen as the     primary outcome variable based on previous experience and literature and is considered as the     major safety concern for the study subjects.   "
155307|NCT01251029|"     Acute kidney injury (AKI) is one of the most serious and frequent complication of general     anesthesia. Patients suffer from chronic kidney diseases (CKD) predispose to develop AKI. CKD     patients often need some surgical interventions that have been done under general anesthesia;     they therefore have an increased probability to develop AKI.      N-acetylcysteine (NAC), a thiol compound with antioxidant and vasodilatory properties,     reduces oxygen free radical production, decreases pump-related ischemia-reperfusion injury     and the levels of pro-inflammatory cytokines. NAC has been reported to protect the kidney     from injury induced by contrast media, ischemia, and toxins.      Present study aimed to explore the efficacy of NAC treatment to prevent deterioration in     renal functioning in CKD patients undergoing major surgery under general anesthesia.      Study will include about 200 CKD (eGFR (estimated glomerular filtration rate) less than 40)     patients that should undergo surgical interventions under general anesthesia and will divide     to 3 groups as follows: group 1- about 40 patients which should undergo major vascular     surgery; group 2 - about 60 patients that suppose to undergo major orthopedic surgery     (revision of total hip, revision of knee); group 3 - about 100 patients undergoing major     abdominal surgery. Patients from each group will randomly divide in two sub-groups (A and B).     Subgroup A will receive NAC twice (14-16h and 2h) before surgery and 12h after surgery.     Subgroup B will receive placebo (saline).      Markers for kidney function such as eGFR, creatinin, urea, electrolytes, cystatin C, NGAL     (Neutrophil Gelatinase-Associated Lipocalin), urine albumin will measure before and after     surgery in all patients. An additional blood samples for assessment of nitric oxide and     cytokine levels will be taken from each patient before and after surgery.   "
155308|NCT01251016|"     Type 2 diabetes mellitus (T2DM) is a relevant public health problem and obesity has been     associated as the major risk factor. Roux-en-Y gastric bypass is an effective method to treat     severe obesity, and its metabolic benefits can lead to early and complete remission of T2DM,     even before a considerable weight loss. We have hypothesized that intestinal anatomic changes     may change intestinal genes expression related to glycemic control. The knowledge of     mechanisms mediating the glycemic control after Roux-en-Y gastric bypass and it site of     action in bowel may eventually help to develop alternative, less invasive and safer surgery     for the treatment of T2DM, as well as drug development for the newly targets identified.   "
155309|NCT01251003|"     The purpose of this study is to determine if it is safe to use stored autologous Human     Umbilical Cord Blood (hUCB) to treat pediatric patients that sustain a severe or moderate     Traumatic Brain Injury (TBI), and have not fully recovered as measured by the Glasgow Outcome     Score-Expanded (GOS-EC)/Child at 6 to 18 months post-injury.   "
155316|NCT01250912|"     Some patients are at risk for life-threatening fast heart rates. These can frequently be     treated by using a catheter inside the heart to burn away the cells that create the fast     heart rates. The purpose of this study is to image the nerves inside the heart of those     patients. The investigators want to find out if abnormalities in the nervous system in the     heart can help the physician to find the area that needs to be burnt away.   "
155411|NCT01249651|"     Administration of esomeprazole 40 mg to subjects who still had heartburn after receiving     rabeprazole 20 mg once daily for 4 to 8 weeks will result in statistically significant     improvement of heartburn after 8-week treatment.   "
156050|NCT01241227|"     The aim of this prospective study was to compare the 5-year prognostic value of transient     elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting     survival and complications of cirrhosis in patients with chronic liver diseases.   "
155317|NCT01250899|"     This is a research study to look at vitamin D deficiency (low levels) in men and women with     HIV. As part of your regular medical care, you will be screened for vitamin D deficiency. If     your levels are low, and you choose to start using vitamin D supplements, the investigators     would like to take some blood before and after you start using vitamin D to see how this     affects your levels of HIV, T cells, cholesterol, and other blood levels. The investigators     will provide you with vitamin D supplements for the first 24 weeks (6 months) of the study.     If you and your physician decide that you should continue taking vitamin D supplements after     that time, you will be responsible for purchasing your own vitamin D supplements.   "
155318|NCT01250886|"     The purpose of this study is to determine whether fluid administration in patients undergoing     colonoscopy should affect acid-base disorder in term of the strong ion differences.   "
155319|NCT01250873|"     LY2216684 is being studied as adjunctive treatment for MDD in patients who are partial     responders to SSRIs. Sertraline is a medication that is widely used to treat MDD and it is a     known substrate of CYP450s, including CYP2D6, CYP2C19 and CYP3A4, and a modest inhibitor of     CYP2D6. Based on the diversity of hepatic metabolic clearance pathways for LY2216684 and its     elimination by the kidney, it is expected that CYP2D6 inhibition by sertraline will not     result in a substantial change in the PK profile of LY2216684. LY2216684 is only known to be     a moderate inhibitor of CYP2C19 so it is unlikely that coadministration of sertraline with     LY2216684 will result in a clinically meaningful change in the PK of sertraline. This study     is being conducted to test these hypotheses.   "
155320|NCT01250860|"     The assessment of influence joint physiotherapy (DoboMed and OMT Kaltenborn - Evjenth) on the     function of the respiratory system and the morphology of the ribcage in short-term intensive     physiotherapy.   "
155321|NCT01250847|"     The primary objective of this study is to assess the effects of 'Seroquel-XR' on the verbal     learning ability in people with at-risk mental state (ARMS) over a 12 week period. The verbal     learning ability will be indexed by delayed free recall score of CVLT(California Verbal     learning Test), a standard neuropsychological verbal memory tests.      The secondary objective is to assess the effects of 'Seroquel-XR' on other cognitive function     and psychiatric symptoms including psychotic, anhedonic symptoms, and impulsivity. The     cognitive function abilities will be measured by standard neuropsychological tests as     follows;        -  Working memory: verbal & spatial 2-back test        -  Attention: Digit Span, 3-7 CPT(Continuous Performance Test)        -  Executive function: WCST (Wisconsin Card Sorting Test)        -  Visuo-spatial ability: Rey Complex Figure Task copy        -  Visuomotor speed and planning: Trail making test A & B        -  Verbal fluency: Controlled Oral Word Association Test(COWAT) The scales of psychiatric          symptoms which will be used are as follows;        -  Psychotic symptoms: Scales of Prodromal scales (SOPS), Positive and negative syndrome          scale (PANSS)        -  Anhedonia: Social Anhedonia Scale (SAS), Physical Anhedonia Scale (PAS)        -  Social cognition: Ambiguous Intention Hostility Questionnaire (AIHQ)        -  Impulsivity: Barrett Impulsivity Scale (BIS)   "
155322|NCT01250834|"     This study will assess if giving LY2189265 at the same time as atorvastatin affects how the     body absorbs atorvastatin.   "
155323|NCT01250821|"     Ovulation disorders are a common cause of infertility in women. Most of these women can be     classified as World Health Organization (WHO) Group II anovulatory patients as they have     irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation     hormone (FSH) and estradiol.      The purpose of this study is to optimize the low-dose-step-up protocol traditionally used for     ovulation induction with follicle-stimulating hormone (FSH) in women with anovulatory     infertility WHO Group II.      Previous studies have established that menstrual cycle history, mean ovarian volume and BMI     are significant predictors of FSH threshold dose in women with anovulatory infertility WHO     Group II undergoing ovulation induction (Nyboe Andersen et al., 2008). A FSH dosage nomogram     has been constructed based on these variables.      The aim of this study is to evaluate the clinical use of the nomogram in order to test the     use of the variables to determine whether an individualized starting dose of FSH can be used     for ovulation induction in anovulatory patients.      It is the hypothesis that an individualized starting dose of gonadotrophin will minimize the     disadvantages of the treatment and that the stimulation period of the individualized     nomogram-based treatment will be 25% shorter than observed in the standard protocol.      The primary endpoint is the proportion of patients who reach the criteria for     hCG-administration within 14 days of Menopur stimulation. The results of the study will be     compared with the data obtained in the Menopur Ovulation Induction Trial (Platteau et al.,     2006).   "
155324|NCT01250808|"     Multiple Myeloma (MM) is the second diagnosed malignancy of hematological malignancies. The     previous study pointed out that the dosage and course of Bortezomib including the dose of     concomitant drugs used to treatment MM patients did not get the preferred treatment program,     so we are going to determine the optimal doses and course of Bortezomib through the     prospective, multicenter clinical trial and evaluate the efficiency and safety of different     program.   "
155325|NCT01250795|"     The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1     Vaccine in healthy adults.   "
155326|NCT01250782|"     Recent reports suggest that most beneficial results of glutamine have been obtained with the     parenteral administration of high doses of glutamine (0.35 g/Kg/d) and in some special group     of patients, such as traumatic patients. Nevertheless total parenteral nutrition is not often     used in critically ill patients.      The endovenous administration of the the dipeptide N(2)-L-alanyl-L-glutamine in trauma ICU     patients can reduce the number of infections, ICU length of stay and mortality.      This benefit can be achieved independently the type of nutrition (enteral or parenteral     nutrition), being a pharmaconutrient.   "
155327|NCT01250769|"     This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning     modalities on oral health.   "
172038|NCT00092391|"     The purpose of this study is to determine the mumps virus strength at the end of shelf-life     (expiration date) of an approved vaccine.   "
155609|NCT01247064|"     The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS)     improves respiratory distress in children 2-23 months presenting to the emergency department     (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with     a trial of nebulized albuterol.   "
155328|NCT01250756|"     Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group     1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular     pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up     doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to     demonstrate that the immune responses as measured by serum antibody responses to diphtheria     toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by     DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP     given alone. In addition, the study aims to evaluate the side effects (safety profile) after     vaccination of 7vPnC when given with DTaP in healthy Japanese infants.   "
155329|NCT01250743|"     The purpose of this pilot study is to learn whether high doses of ascorbic acid (vitamin c),     given intravenously to patients with chronic hepatitis due to infection with the genotype 1     version of the hepatitis C virus, are safe, well-tolerated and able to reduce the amount of     virus circulating in the patients' blood.   "
155330|NCT01250730|"     The purpose of this study is to investigate the pharmacokinetics of single doses of     PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male     volunteers.   "
155331|NCT01250717|"     The purpose of this research study is to determine if the combination of chemotherapy and     hormone therapy is safe and helpful for patients who plan to have their high-risk prostate     cancer surgically removed. Some physicians believe that patients with high risk cancer that     is located in one area, may have an early but small spread of the cancer outside of the     prostate, and perhaps even to distant organs. Therefore, better treatments for the entire     body are needed to improve the ability of surgery or other local therapies to cure prostate     cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced     prostate cancer patients, it is possible that using chemotherapy combined with hormonal     therapy earlier in the course of localized but high risk patients might improve the outcomes     for these patients.   "
155332|NCT01250704|"     Neuromyotonia (NMT), so called Isaac's syndrome, is a rare disorder in which     hyperexcitability of peripheral motor nerves leads to intermittent muscle contractions. It is     characterized by muscle twitching at rest (visible myokymia), cramps, hyperhidrosis,     paraesthesiae, mild muscle weakness. and impaired muscle relaxation, or pseudomyotonia.     Electromyographic recording is a key diagnostic tool in detecting myokymia and neuromyotonia.     Pathophysiology of neuromyotonia is claimed to be related immune disorder, autoimmune     anti-voltage-gated potassium-channel antibodies and genetic mutation in potassium channel.     KCNA1 (Kv1.1) mutation was mostly reported in a autosomal dominant trait. In the present     study, we report a family affected with myokymia，worsening with elevated body temperature,     febrile illness or spicy food. How the change in temperature influence clinical features of     channelopathies is an interesting topic. Variant clinical severity of family members are     recorded. The index patient has possible autoimmune mechanism involvement because of his     clinical feature of myasthenia gravis with thymoma and hyperthyroidism. Further analyzing the     genetic mutation in potassium channelopathy may provide researchers some pathophysiological     insight into the Isaac's syndrome.   "
155333|NCT01250691|"     This study will carry out in the ICU. Objectives of the study are to determine the frequency     of HAP and the effect of isolated rooms on the frequency of pneumonia in the ICU.   "
155334|NCT01250678|"     Cognitive impairment is seen in about half of patients with relapsing remitting MS. Our     knowledge about long term development of cognitive performance under natalizumab therapy is     limited. We want to demonstrate with this study that patients treated with ntz improve in     neurocognitive tests over the long term.   "
155335|NCT01250665|"     This study is a cross sectional study of patients diagnosed with clinically isolated syndrome     (CIS) and RRMS, who will undergo a series of tests to assess cognitive impairment, fatigue     severity and depressive symptoms. Cognitive impairment will be assessed with Multiple     Sclerosis Inventory Cognition (MUSIC) and symbol digit modalities test (SDMT), fatigue     severity will be measured with the Fatigue Scale for Motor and Cognitive Functions (FSMC) and     depressive symptoms with the Beck Depression Inventory (BDI). All tests mentioned above are     validated for MS patients. In the second step we will use our large longitudinal database of     serial MRI examinations from which a linear measurement of CCI will be retrospectively     calculated.   "
155336|NCT01250652|"     Allen Kaplan is a prominent American allergist with the reputation of leader in the field of     chronic urticaria. He advocates treatment with first generation hydroxyzine, which he     considers at least as effective as modern second generation H1-blockers in suppressing the     symptoms of difficult-to-treat / systemic-steroid-dependant cases of chronic urticaria. He     further speculates that hydroxyzine may have the advantage to better suppress itch and     improve nighttime sleep. This has prompted many practitioners around the world to believe     that adding hydroxyzine to the treatment regimen at bed time at night may be beneficial to     patients. At the same time European guidelines indicate modern second generation H1-blockers     in higher than conventional doses as drugs of choice for such cases. However, there is no     evidence from clinical trials addressing this controversy. The investigators' previous     studies suggest that levocetirizine at quadruple doses may be beneficial in difficult to     treat urticaria by reducing lesions and itch, improving quality of life and night time sleep,     while not causing day time somnolence. First generation H1-receptor antagonists and     hydroxyzine among them are known to penetrate the blood / brain barrier and to cause     sedation. The question stays whether this sedation is beneficial to the subjects with chronic     urticaria at night, whether it has any hang-over unwanted effects the following day and     whether this has any influence on the overall urticaria-specific quality of life.   "
155337|NCT01250639|"     This study is a cooperative project and aims to identify genetic components associated with     type 2 diabetes mellitus (T2DM), which is significant for the population of non-aboriginal     Taiwanese.   "
155338|NCT01250626|"     Inulin's usefulness as a diagnostic agent is based on the method of its elimination from the     body. Inulin is biologically inert, unbound by plasma proteins, freely filtered at the     glomerulus, and is neither reabsorbed, metabolized nor secreted by the kidneys. It is     excreted almost entirely by glomerular filtration. Inulin clearance is considered to be     identical to glomerular filtration rate (GFR).   "
155339|NCT01250613|"     Genomic aberrations in patients diagnosed as congenital malformation with unknown etiology     will be identified using high-density oligonucleotide array.   "
155340|NCT01250600|"     Although a lot of evidence and guidelines recommend that patients have cardiac     rehabilitation, in reality, the actual rate cardiac patients entering cardiac rehabilitation     program is low, usually less than one third. One of the main hindrances of patients     participating cardiac rehabilitation program is insufficient number of medical institutions     that can provide rehabilitation services. Patients usually cannot perform exercise program     under medical professionals monitoring without having to go far. This spatial and temporal     difficulty led to the low rate of patients taking cardiac rehabilitation program. The risk of     patients to do exercise is higher than healthy adult.      This project will develop the intelligent portable remote care system for cardiopulmonary     exercise to provide an instant ECG monitoring service through the integration of front-end     wireless ECG measuring devices, expert system, and back-end tele-care platform. Many patients     are inconvenient to go to large hospital regularly for cardiac rehabilitation training. This     project will help them to exercise at home after once or twice rehabilitation training in     clinic for each month and the medical professional will supervise remotely to see how much     exercise they did. For that reason the project can help to break through spatial and temporal     difficulty of having cardiac rehabilitation, so that cardiac rehabilitation can be help more     patients. Patients have this tele-care system while they are doing exercise at home, the     built-in heart rate and cardiac rhythm warning function will remind them to take a break,     even to take medical treatment. More importantly, the ECG signal can be almost immediately     (real time) uploaded by network to the chest pain unit of hospital. The cardiology expert     will be aware of the warning at the first moment. This is an important protection to     patients' safety of doing rehabilitation sports at home.      This randomized control trial will recruit 80 patients who had myocardial infarction within 6     weeks, and are not able to attend a hospital based cardiac rehabilitation program regularly.     All patient will undergo a three-month home exercise program under the instruction provided     by the physiatrists and physiotherapists. Forty of them (the remote-care group) will use the     intelligent portable remote care system for cardiopulmonary exercise to monitor their     exercise intensity and cardiac rhythm during exercise. The other 40 patients (the control     group) undertake the exercise program at home without using the remote care system. The     efficacy and safety of exercise program will be compared between the two groups.   "
155341|NCT01250587|"     The purpose of this study is to determine a safe and effective dose range for intravenous     administration (infusion) of PDC31 by determining the maximum tolerated dose of PDC31 in     patients with primary dysmenorrhea.   "
155342|NCT01250574|"     Postoperative complications, especially bacterial infections, are relatively common and cause     increased morbidity and mortality. Effective and timely antimicrobial treatment is important     for prognosis, and delayed diagnosis and treatment substantially increase mortality. The     early diagnosis of infection and sepsis are today based on diagnostic tests that have been     available for years, like WBC count, SR and CRP. These markers suffer from several drawbacks;     their sensitivity and specificity for infection and sepsis are not good enough and their     kinetics are rather slow in terms of both increase and decrease. A major disadvantage of CRP     is that after surgery and trauma this marker generally increases for several days, reaching a     plateau typically on day 2-4 following the event, and therefore, in most cases do not offer     the needed guidance for early treatment of bacterial infection. More recently, other     biomarkers for infection and sepsis have become available, some of which appear acceptable     for diagnostic use. Procalcitonin (PCT) and neutrophil CD64 are both promising new markers     for the early detection of infection. They do both have their pros and cons compared to each     other and compared to the traditional markers, such as CRP and WBC count. It is a general     view that further research is needed before these markers will be accepted as part of the     routine protocol for the diagnosis of infections, especially in relation to postoperative     complications. The aim of the present study is to investigate the clinical utility of     procalcitonin (PCT) and neutrophil CD64 as markers for infection and inflammation:        -  to evaluate if it is possible to detect early phase postoperative infections by using          these tests versus traditional markers such as CRP, SR and WBC count (with          differential).        -  to differentiate between systemic bacterial infection and systemic inflammation due to          the surgical trauma.      The hypothesis is that PCT and neutrophil CD64 are more sensitive and specific analysis for     the early detection of infection after abdominal surgery than CRP (and other widely used     tests for inflammation and infection), and that neutrophil CD64 is more specific than PCT.     Patients admitted to the Department of Gastroenterological Surgery, Akershus University     Hospital for elective abdominal surgery will be included in the study after informed consent.     Initially consecutive series of 150 patients will be included, but this number may be     increased depending on the number of observed infections during the course of the study. All     patients will be monitored and treated by the formal protocol related to clinical signs of     infection, such as abcess, peritonitis, pneumonia, sepsis and septic shock. In addition to     the analytical parameters routinely used today in order to discover infections (CRP, WBC     count etc), blood samples for PCT and neutrophil CD64 will be analyzed before surgery and     daily during the stay at the hospital. In the case of signs of infection, locally or     systemic, the frequencies of analysing PCT and CD64 will be increased according to the     severity of the changes in the clinical condition. The expression of CD64 will be measured by     flow-cytometry and PCT will be measured by an immunochemical method.   "
155343|NCT01250561|"     The addition of gabapentin therapy to standard antiviral treatment with valacyclovir in acute     herpes zoster patients will decrease the incidence of post-herpetic neuralgia.   "
155344|NCT01250548|"     The purpose of this study is to compare the effects of apremilast with a placebo (an inactive     substance that looks like apremilast) on you and other people with rheumatoid arthritis.      The investigators will be collecting information in this study to help us determine -        -  the safety of apremilast in patients with active rheumatoid arthritis        -  how long it takes for patients with active rheumatoid arthritis to respond to apremilast        -  how long the effects of apremilast last after the treatment has ended.   "
155345|NCT01250535|"     Drug-drug interactions play an important role in clinical adverse events due to the     prevalence of multi-drug therapy. Co-administration of warfarin and a statin has expanded     substantially in the US over the last decades. The purpose of this study is to develop a     mechanistic understanding of the role of a drug-metabolizing enzyme, CYP4F2, in the     interaction between warfarin and statins. This study will test the hypothesis that lovastatin     potentiates the anticoagulant effect of warfarin by inducing vitamin K-metabolizing enzyme     CYP4F2 in humans, thus increasing warfarin's anticoagulant effect.   "
155346|NCT01250509|"     The purpose of this study is to determine whether a mindfulness-based stress reduction and     mindful eating program will lead to reductions in abdominal fat and total weight and improve     cell aging in overweight and obese women compared to a waitlist control group.   "
155347|NCT01250496|"     The routine administration of 75 mg of intravenous aminophylline following regadenoson     (Lexiscan®), a commonly used medication for nuclear stress testing of the heart, can reduce     the gastrointestinal (diarrhea and stomach upset) and other side effects related to     regadenoson.   "
155348|NCT01250483|"     The correlation between the change of serum prostate-specific antigen (PSA) or PSA velocity     (PSAV) and severity of lower urinary tract symptoms (LUTS) has been poorly understood.     Previous studies usually focused on the treatment efficacy or preventive role of alpha     blockers (AB) for clinical progression of benign prostatic hyperplasia (BPH) and AB therapy     in real-life practice improved BPH/LUTS and reduced the risk of overall clinical progression.     We hypothesized that the change of PSA and PSA velocity would be correlated to LUTS severity     in the groups of BPH and prostate cancer.   "
155349|NCT01250470|"     This phase I trial studies the side effects of vaccine therapy when given together with     sargramostim in treating patients with malignant glioma. Vaccines made from survivin peptide     may help the body build an effective immune response to kill tumor cells. Colony-stimulating     factors, such as sargramostim, may increase the number of white blood cells and platelets     found in bone marrow or peripheral blood. Giving vaccine therapy and sargramostim may be a     better treatment for malignant glioma.   "
155350|NCT01250457|"     The purpose of this research is to find out if the use of topical timolol 0.5% solution     applied twice daily will help to shrink rosacea lesions around the eye.   "
155351|NCT01250444|"     The purpose of this study is to determine inspiratory muscle training effects on blood     pressure, functional capacity and quality of life in hypertensive patients.   "
169724|NCT00050947|"     This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as     monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of     age.   "
155352|NCT01250431|"     The purpose of the study is to measure the change in psychological symptoms and gene     expression in war veterans after a series of 10 EFT coaching sessions. Outcome studies have     shown statistically significant reductions in depression, anxiety, and PTSD in veterans after     EFT, and this study extends earlier research using biological sampling. EFT is a form of     Energy Psychology (EP) that is sometimes referred to as emotional acupuncture. It involves     self-stimulation of 14 acupuncture points at the end of meridians with the fingertips, while     recalling an emotional event such as a combat trauma. It is typically effective in 6 to 15     coaching sessions, making it an efficient clinical technique for reducing affect.   "
155353|NCT01250418|"     The study question: Does the SNAP-Index (SI) correlates better with the OASS than the BIS     Monitor during sedation with ketamine?      The study hypothesis: Since the SNAP II monitor seems to be more responsive during emergence     of anesthesia, it will have a better correlation with the OASS than the BIS monitor with the     use of ketamine.   "
155354|NCT01250405|"     The primary objective is to determine whether reduction of serum calcium concentration by     cinacalcet leads to reduction of mean blood pressure adjusted c-fPWV. The secondary     objectives are to study the effects of calcium reduction on 1) carotid-radial PWV (c-rPWV),     2) common carotid artery (CCA) biomechanics, 3) pulse wave profile and cardiac function.   "
155355|NCT01250392|"     The goal of this project is to see if behavioral nudges will increase an individual's     likelihood of participating in a nurse visit. The behavioral nudges under consideration are     encouraging subjects to make an active choice and sending reminders.   "
155356|NCT01250379|"     This randomized, open-label, parallel-group study will assess the efficacy and s afety of     Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second-     and third-line therapy in patients with locally recurrent o r metastatic breast cancer     progressing after first-line therapy with Avastin and chemotherapy. Patients will be     randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks     intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study     treatment is until third-line disease progression or unacceptable toxicity occurs.   "
155357|NCT01250366|"     The purpose of this study is to determine the Safety and Pharmacokinetics of Multiple     Ascending Oral Doses of INX-08189 in Chronically-infected Genotype 1 HCV, Treatment-naïve     Subjects.   "
155358|NCT01250353|"     The main problem of ocular surface reconstruction is the lack of viable conjunctival tissue.     The use of a biocompatible latex biomembrane in ocular surface healing, like post pterygium     surgery, could be an alternative therapeutic resource to this process.   "
155359|NCT01250340|"     In individuals with Type 2 Diabetes (T2D) it has been obtained an outstanding improvement in     the management of hyperglycemia, but it has not been achieved a similar result in the     reduction of the atherosclerotic syndrome. The comprehension of the mechanisms that link over     nutrition to inflammation and innate immune response can be important to understand the     relationship between insulin resistance, diabetes mellitus and endothelial dysfunction. It     will be investigated: 1) the role of Toll Like Receptors (TLR)s in the pathophysiology of T2D     and associated atherosclerosis; 2) the role of aspirin and nicotinamide adenine dinucleotide     phosphate (NADPH) oxidase inhibitor/s in the production of TxA2 and F2-isoprostanes in T2D     patients; 3)new biomarkers associated to Diabetes and atherosclerosis including markers of     endothelial dysfunction and cytokines.      It will be analyzed in isolated platelets from normal controls and/or diabetic patients the     production of TxA2, isoprostanes and pro-inflammatory/thrombotic cytokines using aspirin and     NADPHoxidase inhibitors.   "
155360|NCT01250327|"     This prospective interventional study is designed to evaluate the cost/advantage ratio in the     treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary     valved stent (Melody).   "
155361|NCT01250314|"     Rational: Osteoporosis in men is responsible for one third of fragility fractures. However     the definition and especially the determinants of fracture in humans are less well known than     in women.      Primary Objective: To search radiologic, biochemical, genetic and micro-architecture bone     factors associated to fractures in men with low bone density.      Study design: case/control study (fracture vs. no fracture) with men selected according to     low bone density (Z-score<-2).      Eligibility criteria: Included subjects will be men whose age is ³ 40 and £ 70 years with a     Z-score< -2 at least at one of the 3 measured sites (wrist, lumbar spine, femoral neck).     Subjects with secondary osteoporosis will be excluded (corticosteroid treatment,     hypogonadism, …) Progress of the study: The recruitment will be over two years. The study     will include two periods, an inclusion visit and a period of 3 months to achieve radiological     and biological examinations. The subjects will be recruited in the 3 rheumatology departments     (LARIBOISIERE, COCHIN). Subjects will be investigated at LARIBOISIERE hospital to perform     radiological examinations and biological sampling for laboratory tests within 3 months of     enrollment.      Evaluation criteria: Biochemistry: dosages of sexual steroids, bone remodeling markers and     homocysteine; Genetic: evaluation of polymorphism of candidates genes associated to fragility     fractures (collagen type I, homocysteine, LRP5); Radiology: evaluation of bone     micro-architecture with a scan of lumbar spine and hip and peripheral micro-scan (XTREME     sSCANCO) and bone densitometry at spine, femoral neck and wrist.      Duration of participation: there is no follow up Total duration of the study: 2 years and 3     months. Number of subjects: 100 patients with fracture and 100 controls without fracture   "
155394|NCT01249872|"     Adequate postoperative analgesia can facilitate recovery following gastric bypass surgery for     morbid obesity. The efficacy and safety of intravenous patient - controlled analgesia has     been studied, but up to date no data are available concerning the use of thoracic epidural     patient-controlled analgesia regarding the use of levobupivacaine combined with morphine in     morbidly obese patients. The investigators' aim in this prospective, randomized,     double-blinded study was to compare the analgesic effectiveness, the dose requirements and     side effects of thoracic epidural patient controlled analgesia 0.1% and 0.2% levobupivacaine     combined with a continuous epidural administration of morphine, with or without a loading     dose, after open gastric bypass for morbid obesity.   "
155465|NCT01248949|"     To determine the maximum tolerated dose or optimal biological dose, and the safety profile of     MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in     subjects with advanced solid malignancies resistant to standard therapy.   "
155362|NCT01250301|"     The aim of this study is to determine if using a behavioural replacement for smoking     (de-nicotinised cigarettes; DNCs), in addition to standard treatment during the first two     weeks after the target quit date, can reduce urges to smoke over the first 4-weeks of     abstinence. Two hundred smokers who want to quit will be recruited from the community. They     would all receive standard smoking cessation treatment from the NHS Stop Smoking Service (NHS     SSS), which uses a combination of stop smoking medication (e.g. nicotine replacement therapy,     Champix) and motivational support. On their target quit date, participants would be     randomised to receive behavioural replacement ( i.e. use of de-nicotinised cigarettes) plus     standard treatment for the first two weeks of their quit attempt, or to continue with     standard treatment alone. De-nicotinised cigarettes are similar to standard cigarettes except     that they do not deliver nicotine to the smoker. Participants will rate their urges to smoke     at each week. Standard NHS SSS measures will also be taken in addition to user acceptability     ratings and reactions to smoking cues.      The hypothesis is that complementing current NHS SSS treatments with de-nicotinised     cigarettes, to address the non-nicotine factors associated with smoking and to help     extinguish smoking behaviour, would result in lower urges to smoke than standard treatment     alone.   "
155363|NCT01250288|"     The purpose of this research study is to describe the usage of consumers and providers when     using a novel technology designed to give consumers the ability to manage and access their     health information. This is a quantitative descriptive analysis study.   "
155364|NCT01250275|"     The fatty acid composition of canola oil will have beneficial acute and chronic effects on     vascular function in individuals with peripheral arterial disease.   "
155365|NCT01250262|"     The purpose of this study is to determine if a 4 month resistance exercise program reduces     the severity of low back pain, pain-related fear avoidance and improves mobility compared to     standard care.   "
155366|NCT01250249|"     To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited     India with BCG vaccine of serum institute of India limited (SIIL), India in 120 healthy     children.   "
155367|NCT01250236|"     Brimonidine, an alpha-2 adrenoceptor agonist, is an effective and safe medication which is     widely used in glaucoma treatment. Although it is known that it is quickly taken up by the     cornea following topical administration and that the cornea has alpha-2 adrenoceptors there     are only few studies available on the impact brimonidine has on the cornea. The aim of the     study is to find out        1. whether topical administration of brimonidine results in interaction with corneal          alpha-2 adrenoceptors in terms of an increase in corneal thickness and        2. whether there are any differences between the response corneal epithelium, stroma and          endothelium show to alpha-2 adrenoceptor stimulation.   "
155368|NCT01250223|"     The F2-study is a complement of the previous studies of the Follicular Lymphoma Prognostic     Factors Project which permitted the development of the Follicular Lymphoma International     Prognostic Index (FLIPI).      The F2-study is designed as a prospective collection of information potentially useful to     predict the prognosis of newly diagnosed Follicular Lymphoma patients, and its purposes are     to validate the FLIPI and to verify whether a prognostic collection of data would allow the     development of a more accurate prognostic index.   "
155369|NCT01250210|"     The primary objective was to evaluate the adequacy of ovulation suppression, cycle control,     and safety of three transdermal contraceptive delivery systems (TCDSs) containing 2 different     doses of levonorgestrel (LNG) and 3 different doses of ethinyl estradiol (EE) during 3     consecutive cycles of administration of each treatment.   "
155370|NCT01250197|"     This is a double-masked, single-center, crossover study in which normal volunteers will be     randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8     days. Subjects will undergo a minimum 7-day washout, and then receive the alternate treatment     for 8 days.   "
155371|NCT01250184|"     Background: Myofascial pain syndrome (MPS) of the shoulder girdle and cervical region is a     common musculoskeletal problem that is often chronic or recurrent. It has demonstrated the     effectiveness of different treatments such as exercise, injection but not comparing them with     each other. The objective of this research was to demonstrate whether lidocaine injection     into trigger points combined with a physical therapy program was more effective than each     separatetreatment in improving pain, function and quality of life in a group of patients with     myofascial pain syndrome (MPS) of the shoulder girdle and cervical region.      Design: Single-blind, randomized, controlled clinical trial with three parallel groups in the     departments of physical medicine and rehabilitation of two urban hospitals. There were 127     patients with myofascial pain in the shoulder girdle for more than six weeks in length and     pain greater than 40 mm on the visual analog scale (VAS). There were three intervention     groups: physical therapy (PT), lidocaine injection (LI), or the combination of both (PT +     LI). The primary outcome at one month was the VAS, and the secondary outcomes were measured     using the SF36 pain scaleat one and three months.      Keywords: Myofascial pain, trigger points, lidocaine injection, physical therapy.   "
155372|NCT01250171|"     This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg     or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition, the     pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were     assessed. Blood samples were collected for the analysis of the effect of secukinumab and     canakinumab on select biomarkers.   "
155373|NCT01250158|"     The purpose of this study is to determine whether the PILP-kit can be safely used, within     specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic     drug for the treatment of patients with unresectable liver metastases.   "
155374|NCT01250145|"     This study is a Phase 1, multi-center, 2-part, subject- and investigator-blind, randomized,     placebo-controlled, multiple dose study of transdermal teriparatide (80-µg dose) in healthy     postmenopausal women. Part A will examine the cumulative irritation and adherence of the     transdermal patch, and Part B will examine skin sensitization and adherence. Two separate     groups of subjects will be enrolled for Part A and Part B of the study. All screening     procedures will take place up to 28 days prior to enrollment.   "
155406|NCT01249716|"     To assess the effect on geriatric patients of follow-up home visit including nutrition.      The hypothesis is that this can prevent hospital readmissions, and has a positive impact on     functional abilities and quality of life   "
155375|NCT01250132|"     Annual incidence of severe traumatic brain injuries (TBI) varies from 180 to 300 out of     100.000. Mortality or severe sequelae risk is increased 8 fold after a TBI. Studies in adults     showed an ante-hypophyseal deficit in 28 to 68 % of patients with a TBI. The most common     deficit is Growth Hormone Deficit (GHD); followed by gonadotropic and corticotropic     (AdrenoCorticoTropic Hormone (ACTH)) insufficiencies. Thyrotropic deficits     (Thyroid-Stimulating Hormone (TSH)) are less frequent. From a pathophysiological point of     view, the lesional mechanism responsible for hypopituitarisms would be a damage of     hypophyseal vessels or hypothalamic-pituitary vessels. The frequency of pituitary deficits     and the potential beneficial effects of replacement therapy on quality of life, tiredness,     loss of energy and productivity, justify the systematic detection of the deficits in patients     with moderate to severe TBI.      Study hypotheses :      At the present time, the lack of data in children does not give us the opportunity to affirm     that one part of the symptoms showed by children with post-TBI neuropsychological sequelae,     are linked to pituitary deficiency and that they can be improved with a replacement therapy.      Firstly, it is essential to better understand the natural history of post-TBI pituitary     deficiencies, studying the connexion between observed deficiencies in acute and late phase of     sequelae.   "
155376|NCT01250119|"     This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in     newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer     (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm     study to evaluate progression-free survival and quality of life with first-line Tarceva     (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily.     Anticipated time on study treatment is until progressive disease or unacceptable toxicity     occurs. Patients with negative EGFR mutation results will be offered treatment as per the     centre's standard of care.   "
155377|NCT01250106|"     The investigators aim to test the hypothesis that Lactobacillus Reuteri-enriched microbiota     improves insulin sensitivity and glucose tolerance in obese healthy and obese type 2 diabetes     patients by improving gut hormone secretion and compare these findings to healthy lean     subjects.   "
155378|NCT01250093|"     In order to investigate the therapeutic effect of acupuncture on chronic neck myofacial pain     syndrome, the investigaotrs designed a pilot study of a single-blind randomized controlled     trial. A total of 34 chronic neck myofacial pain syndrome patients were selected from     Department of Neurology of Nantou Hospital, Department of Health. The age ranged from 18 to     85, and all subjects were full informed consent and volunteers. They were divided into two     groups of 17 subjects randomly as follows: acupuncture group, acupuncture stainless needles     were inserted into bilateral Fenhchi, Jianliao and Houxi acupoints, respectively. The     acupuncture needles then were manual twist and de Qi, and remain for 20 min; sham acupuncture     group, the methods were identical the acupuncture group, but acupuncture stainless needles     were inserted into subcutaneous tissue only. All the subjects were treated with acupuncture     two times per week and continuously three weeks, i.e. Six times acupuncture treatment. The     therapeutic effect of acupuncture was assessed before and finishing six times acupuncture     treatment, and four weeks and twelve weeks after stopping acupuncture, respectively. The     index of acupuncture therapeutic effect was according to the range of motion (ROM) of the     cervical spine, the intensity of pain (Short-Form McGill Pain Questionnaire; SF-MPQ) and     quality of life (SF-36). The investigators expect acupuncture apply to bilateral Fenhchi,     Jianliao and Houxi acupoints may relief the pain and motion of chronic neck facial pain     syndrome patient, and also improves the life quality.   "
155379|NCT01250080|"     Glutamine is the most abundant nonessential amino acid in the human body. Besides its role as     a constituent of proteins and its importance in amino acid transamination, glutamine may     modulate immune cells.      The innate immune system is the first line of host defence against pathogens and in most     cases sufficient to eliminate invading microbes. Mammalian Toll-like receptors (TLR) comprise     a family of germ line-encoded trans-membrane receptors which activation leads to the     induction of inflammatory responses, phagocytosis but also to the development of antigen     specific adapative immunity.      It has been postulated though not formally proven yet that glutamine beneficial effect could     be due to a positive effect on the innate immune system. Given the importance of TLRs and     TLRs-dependent signalling in host defence against infections we hypothesized that glutamine     may increase the expression and/or functionality of TLRs which in turn may have beneficial     effects to clear infections.   "
155380|NCT01250067|"     In this proposal, in addition to the conventional MRCP recording, the dipoles and sources of     the different subcomponents of MRCP will also be analyzed with the brain electric source     analysis (BESA) to evaluate the difference in the solutions and source strength underlying     the MRCP between normal controls and patients with ET.   "
155381|NCT01250054|"     The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.   "
155382|NCT01250041|"     Strength of the Quadriceps Muscle is key to recover from Total Knee Arthroplasty. In this     study we compare two techniques for pain control after total knee arthroplasty in terms of     preserving the motor function (the strength of the quadriceps muscles of the thigh) which     will facilitate the rehabilitation and accelerate the hospital discharge. We will use     ultrasound guided technique to block either the femoral nerve in the control group or the     saphenous nerve in the experimental group. The primary outcome is the functional capacity and     the impact of each block on the ability to walk by measuring the distance patients are able     to walk in two minutes in post operative day one in the two groups. The secondary outcome is     the morphine consumption in the two groups.   "
155383|NCT01250015|"     To establish whether provision of numerical data, framed as event rates and illustrated by     pictograms, and including figures for all-cause mortality, affects subjects' attitudes to     colorectal cancer (CRC) screening.      Design and Intervention. Randomised questionnaire and telephone study comparing the responses     of a control group given the standard National Health Service (NHS) CRC screening information     with the responses of an intervention group given the same information but enhanced with     additional numerical and pictorial information.      Setting   "
155407|NCT01249703|"     1. Find the early diagnostic markers of erectile dysfunction;        2. Study the warning role of ED in some diseases.   "
155408|NCT01249690|"     The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen     in newly diagnosed multiple myeloma(MM).   "
155384|NCT01250002|"     Although ambulatory gynecological laparoscopy is considered to be a minimally invasive     surgical procedure, only 60% of patients undergoing this procedure are satisfied with     postoperative pain control. Postoperative pain can lead to physiological, immunological and     psychological derangements in patients.It also has been shown to be the most common cause of     hospital admission after outpatient surgery.      Opioids constitute the most commonly used pain management strategy after surgery, however     they have many undesirable side effects including nausea, vomiting and respiratory     depression. Different strategies have been developed to decrease the amount of opioid     required after surgery. Opioid sparing drugs as well as regional anesthesia have been shown     to be effective. Systemic administration of lidocaine has been shown to decrease opioid     consumption, improve recovery of bowel function and promote a better recovery after inpatient     procedures. Lidocaine has been shown to have analgesic, antihyperalgesic and     anti-inflammatory properties. It also has an excellent safety profile when give by a low-dose     infusion.      The improvement of surgical technique and anesthesia care has made major adverse outcomes     infrequent, especially in the ambulatory setting. Assessing patient's quality of recovery has     become an important outcome in several studies. The patient's capacity to return to his     normal activities is one of the most important sign of a successful outpatient procedure and     it has significant economic implications.      Quality of recovery -40(QoR-40) is a validated 40 item instrument to assess the quality of     post-operative recovery. Myels et al. have concluded that the QoR-40 would be a useful     outcome measure to assess the impact on changes in health care delivery, but anesthesia     studies underutilize this instrument.      The research question for the study is; does the use of systemic perioperative lidocaine     improve quality of recovery after outpatient laparoscopy?   "
155385|NCT01249989|"     The average adult has a poor quality diet and sedentary lifestyle, but the best way to     produce sustained healthy change remains unknown. The MBC2 intervention uses handheld     technology to help individuals monitor and transmit information about their eating and     activity remotely to a behavior coach. The proposed trial tests whether MBC2 intervention     improves diet and activity more than a stress management control condition, and whether     changing multiple health behaviors is best achieved by changing them all at the same time, or     one after another.   "
155386|NCT01249976|"     Removal of a central venous catheter (CVC) is often useful to prove its responsibility in a     bloodstream infection. To avoid unnecessary removal of CVC, some catheter-spearing diagnostic     methods have been recently developed. The aim of the study is to evaluate three     catheter-spearing diagnostic methods in critically ill children: 1) the measurement of the     differential time to positivity between a blood culture drawn from a peripherical vein and     another one drawn through the CVC; 2) the exam of a blood sample drawn for the CVC and     stained by acridine orange leucocyte cytospin test; 3) the semi-quantitative skin culture of     the area around the insertion site of the CVC.   "
155387|NCT01249963|"     The aim of the study is to evaluate the beneficial effects of the administration of enteral     nutrition product with milk proteins, monounsaturated fatty acids and low dextrose equivalent     maltodextrin and enriched in eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and     medium chain triglycerides (MCT) in patients with mild acute pancreatitis. All this against     other specific product.      The main objectives of this project are:        -  Comparing the tolerance of both preparations.        -  Comparing the evolution of nutritional status in both groups.        -  Comparing the evolution of inflammatory parameters in both groups   "
155388|NCT01249950|"     single-center study carried out in order to evaluate in prospective among patients seen or     treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the     potential number of patients eligible for surgery.   "
155389|NCT01249937|"     In the Western World, Age Related Macular Degeneration (ARMD) is a leading cause of     blindness. This disease was once thought to be a natural part of aging, but recent research     has introduced effective treatments. ARMD is related to the body initiating an immune     response in the eye, as if responding to an infection. Vision is impacted as ocular tissue     becomes inflamed and new blood vessels form at the back of the eye, a process called     angiogenesis. In the more severe wet form of ARMD, blood and fluid leak out of the vessels     and impair the eye's structure and function. Many studies have shown that ranibizumab, a drug     that stops the formation of new blood vessels (an anti-angiogenic agent) can delay damage to     the eye and often restore vision. The investigators believe the best drug therapy will also     stop the inflammation. Triamcinolone acetonide, a steroid drug, has shown the potential to     effectively reduce inflammation in this application. The investigators aim to investigate if     patients receiving a combination treatment of ranibizumab and triamcinolone acetonide improve     their visual abilities more than those receiving just ranibizumab treatment alone.     Secondarily, the investigators will also investigate how often patients receiving each drug     therapy regime require re-treatment and how often they experience further vision loss.   "
155390|NCT01249924|"     Objective of the study: To determine whether Perioperative Auto-CPAP treatment prevent     postoperative worsening of OSA and improve nocturnal oxygen saturation in surgical patients     with moderate and severe OSA.   "
155391|NCT01249911|"     Randomized, doble blind, clinical, controlled trial aimed to investigate the role of     Lactobacillus reuteri DSM 17938 in the prevention of gastrointestinal and respiratory tract     infections in mexican children who attend day care centers.      Primary Outcome: The primary outcome will be days with diarrhoea. Secondary Outcomes: a)     Days with respiratory tract infections (RTI); b) Days of absences from day care centre; c)     Days of antibiotic use; d) Days of medical office visits or emergency visits; and e) Direct     and Indirect costs.      Methods: Prospective, randomized, double blind, placebo controlled trial to realize in 260     healthy term infants, born at term (≥36 weeks of gestation), 6 to 36 months old, who will be     recruit from Child Care Centers in Mexico and randomly allocated to receive either 1 x 108     colony-forming units of Lactobacillus reuteri DSM 17938 or placebo, each day for 12 weeks,     follow up for other additionally 12 weeks of observation. Days with respiratory tract     infections (RTI); days of absences from day care centre; days of antibiotic use; days of     medical office visits or emergency visits; and direct and Indirect costs will be compare     between groups using bi-variate, multiple lineal regression analysis and cost-effectiveness     analysis   "
155392|NCT01249898|"     Scaphoid fractures are the most common carpal bone fractures, and second most common wrist     fractures (second to distal radius fractures). Lack of proper immobilization or displacement     of these fractures commonly results in fracture nonunion or malunion followed by the     development of wrist post-traumatic osteoarthritis. In addition, proper reduction and     fixation of these fractures are challenging to the most experienced hand surgeons.      The investigators are going to follow-up the patients population suffering from Scaphoid     fractures(nonunion included) for one year. The investigators will evaluate this follow up     results in two ways:        1. Intra-operative imaging of scaphoid fracture fixation - feasibility evaluation.        2. Treatment of scaphoid fracture non-union.   "
155395|NCT01249859|"     Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the     upper digestive tract in western countries        -  Discordant results in the literature concerning the prognosis value of the presence of          signet ring cells.        -  Preliminary data suggesting (i) an advanced stage at time of diagnosis, (ii) more often          in the form of carcinose, (iii) a more pejorative prognosis, (iv) a recurrence more          frequent, more quickly, and more often in the form of peritoneal carcinose, (v) a chemo          resistance (vi) the need for a specific therapeutic strategy compared to non-signet ring          cell adenocarcinomas.      Primary objective To test the hypothesis that 5-year survival rate is significantly lower in     the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the     upper digestive tract      Secondary objectives        -  Impact of neoadjuvant CT on overall survival        -  Impact and differential diagnostic value of linitis        -  R0 resection rates        -  3 years recurrence free survival        -  Overall 3 years survival        -  Prognostic factors        -  Prognostic value of the presence of a minority quota of signet ring cell        -  Objective response rate after medical treatment (chemotherapy, radiochemotherapy) in          non-resected patients        -  Tolerance of (radio) chemotherapy for ADCI      Methodology Intention to treat retrospective case-control multicentric study A pairing on     demographic criteria (age, sex, ASA score, center) and tumor criteria (TNM stage) will be     done to ensure comparability in case control study groups.      Inclusion criteria All consecutive patients taken care of, for a proven histologically     adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in     surgical or medical oncology investigator centers, will be saved in a given database.      For whom the first consultation took place between January 1997 and January 2010      Exclusion criteria Histological type other than adenocarcinoma Other localization than     esogastric junction, esophagus or stomach      Planned study period The data will be collected over a period from January 1997 to January     2010.      The objective is to complete the data collection for summer 2010.   "
155396|NCT01249846|"     The purpose of this study is to assess the efficacy and the safety of Chlorhexidine Gluconate     Chip (PerioChip®) in frequent treatment versus routine treatment in therapy of adult chronic     periodontitis.   "
155397|NCT01249833|"     This study has been designed to determine if subjects treated with oseltamivir in addition to     standard of care treatment for influenza demonstrate a greater improvement in attention /     working memory / processing speed / mood as compared to subjects receiving standard of care     alone. The cognitive tests employed are objective measures developed and administered online     by HeadMinder Inc.   "
155398|NCT01249820|"     The purpose of this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given     intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem     cell transplant following myeloablative chemotherapy or patients receiving intensive     chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease.   "
155399|NCT01249807|"     Cancer Screening is necessary for promoting cancer prevention in the area of public health.     The Department of Health, Executive Yuan of the Republic of China has expanded and included     colon cancer screening, oral cavity cancer screening, breast cancer screening, and cervical     cancer screening in national-wide preventive healthcare services. However, most of the     Taiwanese do not have the concepts of what cancer screening is and regular participation of     cancer screening. This will easily cause their neglect of quality of personal healthcare and     habits of cancer screening. Recently, in order to reach the national goal of cancer     prevention, the parallel methods, multi-promotion for reinforcing concepts and free cancer     screening, have been utilized to cultivate Taiwanese people's active participation of cancer     screening. Therefore, this study will use health service utilization model to investigate     Taiwanese people's concepts of cancer-related knowledge and the major causes of low     participation of cancer screening.      In order to investigate Taiwanese people's health service utilization model and quality of     health life, this study first review the related regulations and screening rates of cancer     prevention, including cancers of colon, oral cavity, breast, and cervical, in Taiwan. In     addition, the structured questionnaire will be conducted to collect, investigate, and analyze     the relationship between the willingness of participating the aforementioned cancer screening     and personal characteristics, quality of health life, medical history, and concepts of     cancer, etc. It is expected that the results of this study will provide accurate and     effective promotions of cancer screening to medical institutions and medical affairs to     reinforce the concepts of participation for raising the rates of cancer screening;     furthermore, to awaken Taiwanese people's crucial awareness of early treatment improves the     chances of recovery on cancer.   "
155400|NCT01249794|"     Patients with respiratory failure following cardiac surgery are randomized to receive     standard therapy versus non invasive ventilation. The hypothesis is that patients receiving     non invasive ventilation will perform better than those who received standard therapy.   "
155401|NCT01249781|"     The purpose of this study was to explore caregivers stress, family functioning, social     support and family resilience of families whose children had acute lymphoblastic leukemia.     The significantly correlation among caregivers stress, family functioning, social support and     family resilience was also explored.   "
155402|NCT01249768|"     Background:      Parkinson's Disease and the Atypical Parkinsonian Disorder (like Multiple System Atrophy,     Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia) are disease     entities with partly common symptomatology. Especially very early in the course of disease,     the differentiation between both disease entities can be challenging, even for specialists in     the field of movement disorder. However, the establishment of a correct diagnosis is very     important for adequate patientcounseling, treatment and the correct inclusion of patients in     research trials. Ancillary diagnostic investigations are looked upon to aid in this     diagnostic dilemma.      Objective:      To investigate the value of ancillary diagnostic investigations, more specific MRI, analysis     of cerebrospinal fluids and a second opinion in a specialized movement disorder centre, to     differentiate Parkinson's disease and the Atypical Parkisonisonian disorder.   "
155403|NCT01249755|"     Recently our ICU research group developed and validated a delirium prediction model in the     NetherlandsThis. This model has a high predictive value. We want to examine what the     predictive value is in ICUs of other European countries.   "
155404|NCT01249742|"     Background      The treatment of diabetes is multidisciplinary. Alignment of care of the various professional     disciplines is, however, not always optimal. This can lead to confusion about treatment     interventions and behavioral advices. In adolescence, good fine-tuned care is of extreme     importance because of the difficulties in regulation of the disease in this phase of life     (Snoek, 2004). These difficulties are due to biological changes but also to     socio-psychological developmental changes. The adolescents' psychological development demands     more autonomy and responsibility for the diabetes (care) by the adolescent. The social     development can conflict with the treatment regime, because of the adolescents' social needs     (ADA, 2001; Houdijk, 1998; Snoek, 2004). In this study the investigators assess whether an     interactive website, on which adolescents with diabetes and their treatment team can     communicate, leads to better alignment of care and better control over the disease.      Intervention      The diabetes has great impact on the adolescents' everyday life. Finding a balance between     more autonomy, participating in social life with (healthy) peers and control of the disease     is difficult and seems to act as a thread during this phase in life.      This can lead to questions and uncertainty at any given moment. The interactive website     provides the adolescent access to information and to his or her individual treatment plan and     advices fitted to his or her condition and life. The adolescent can pose questions at any     given moment through the online forum and their personal treatment page. Since the treatment     team answers the question within a day, fit between diabetes care and adolescents' everyday     life is optimized.      Research question      Does an online interactive treatment environment, on which adolescents with diabetes can     communicate with their treatment team, lead to better fit of care and to better disease     control?   "
155405|NCT01249729|"     We use the three-dimensional image software reconstruct MRI. The propose of this research     purposes as follows: 1. 3D reconstructed image processing from MRI to realize the short term     nervous system response after dynamic acupuncture stimulation.2. Realizing the corresponding     area in the brain caused by electroacupuncture. 3. Realizing the connection between     electroacupuncture stimulation and brain physics, chemistry, and physiology. The implement     the two-dimentional image into three-dimensional image by Amira software, in order to find     out the difference of the pre-and post- response of the nervous system. In addition, we will     use describe statistics and Paired t-test statistical analysis, compare the statistical     difference of blood oxygen concentration.   "
155412|NCT01249638|"     Patient with multiple metastases, not eligible for surgery, might not profit from intensive     chemotherapy regimens. Therefore less intensive regimens focusing on survival and disease     control may be a better choice for first line treatment. Therefore this study investigates     the combination of capecitabine and bevacizumab versus the combination of capecitabine,     bevacizumab and irinotecan. In case of progressive disease, the therapy in patients treated     with capecitabine and bevacizumab is intensified by adding irinotecan. Primary endpoint is     time-of-failure strategy (TFS) comparing both treatment arms.   "
155413|NCT01249625|"     Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace,     there is very little clinical evidence that respirators prevent healthcare personnel (HCP)     from airborne infectious diseases. Scientific investigation of this issue has been quite     complicated, primarily because the use of respirators has become the standard of care for     protection against airborne diseases in some instances, even without sufficient evidence to     support their use. The key question remains: How well do respirators prevent airborne     infectious diseases? The answer to this important question has important medical, public     health, political and economic implications.   "
155414|NCT01249612|"     With this study the investigators wish to (1) investigate the acute effect of knee joint     icing on knee-extension strength shortly after total knee arthroplasty (TKA); and (2)     investigate the acute effect of knee joint icing on knee pain, knee joint circumference and     functional performance shortly after TKA.   "
155415|NCT01249599|"     The aim of this prospective single-center study is to evaluate endothelial function, arterial     compliance, sympathetic nervous activity at rest and after mental and physical stress,     carotid atherosclerosis, oxidative stress parameters, quality of life and platelet adhesion     in patients with apical ballooning syndrome and age-matched controls.   "
155416|NCT01249586|"     E-learning material increases the student knowledge level before the traditional class of     blindness prevention and help to fix this information a short period (one month) after the     class.   "
155417|NCT01249573|"     This study investigates the immediate effect of fascia therapy and transcutaneous fibrolysis     in the treatment of an acute ankle sprain. These treatments will be compared to a placebo     group.   "
155418|NCT01249560|"     The objective of the antiretroviral treatment is to inhibit the viral replication,     estimated(appreciated) by the measure of the viral plasmatic load(responsibility). In this     inhibition of the viral replication usually joins an immune reconstruction [ 1 ].     Nevertheless, a viro-immunological dissociation, i.e. an undetectable viral     load(responsibility) and an absence of immune reconstruction, is regularly observed. It is     now turned out that an undetectable viral load(responsibility) does not correspond to the     total absence of viral replication and that it is possible to detect of the intracellular     pro-viral DNA . Raltegravir ®, because of its mode of action(share) inhibiting the     integration of the pro-viral DNA in the chromosomes of the infected cells(units) , could     decrease the intracellular reservoir of monocyte-macrophages, improve the homeostasis, so     optimizing the cooperation lymphocytes T - macrophages. Several experimental data suggest     that the regression of the abnormalities of cellular interactions, and the rate of apoptose     abnormally raised(abnormally brought up) by cells(units) T at the patients in     viro-immunological dissociation, could be obtained .      This study aims at measuring the impact of Raltegravir ® on the viral reservoirs lymphocyte     and monocyte, to quantify the expression of the molecules of costimulation, the     source(spring) of intercellular interactions lymphocytes - monocytes, and to measure the rate     of apoptose of the cells(units) T.   "
155419|NCT01249547|"     This is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety     of single-agent axitinib in recurrent or metastatic NPC patients who failed at least one line     of platinum based chemotherapy.   "
155420|NCT01249534|"     Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive     protein (CRP) in the postoperative course. The aim of this study was to evaluate the     diagnostic accuracy of CRP for postoperative inflammatory complications after     gastroesophageal cancer.   "
155421|NCT01249521|"     This is a clinical trial investigating the effectiveness and safety of the combination of the     study drugs bevacizumab and AMG386 in patients with advanced (metastatic) chemotherapy-naive     bowel (colorectal) cancer. Chemotherapy has a significant impact in metastatic bowel cancer     in terms of maintenance of quality of life and extension of survival. However, ultimately     tumours will develop resistance to these agents and further treatment options are urgently     required.      Angiogenesis is a process that results in the formation of new blood vessels. Similar to     normal tissues, solid tumours require new blood vessels for growth and survival. Hence, drugs     targeting angiogenesis may be useful treatment options for patients with bowel cancer.      AMG386 and bevacizumab act on 2 different pathways relevant to angiogenesis. There is     evidence from laboratory and animal studies to suggest that such a combination could be     useful as a cancer treatment. Previous studies in humans have shown that AMG386 and     bevacizumab can be combined safely.. This study aims to evaluate the effectiveness and safety     of the combination of AMG386 and bevacizumab in patients with advanced bowel cancer.      40 patients from approximately four hospitals in Australia will participate in this trial,     with approximately 20 patients being enrolled at Austin Health. All participants will receive     the same treatment.   "
155422|NCT01249508|"     This study aims to evaluate a nutrition labelling program in improving university canteen     customers' dietary pattern and behavioural determinants (e.g. knowledge).   "
155424|NCT01249482|"     Background: Rebound acid hypersecretion and acid-related symptoms after discontinuation of     proton-pump inhibitor has been reported in previous studies. In patients with concurrent     gastro-esophageal reflux disease and Helicobacter pylori infection, whether eradication of     Helicobacter pylori (H. pylori)will aggravate acid-related symptoms after discontinuation of     proton-pump inhibitor remains elusive Objective: This study aims to investigate the incidence     and severity of acid-related symptoms after discontinuation of proton-pump inhibitor in     reflux patients receiving H. pylori eradication.   "
155610|NCT01247051|"     The study is a single-center, randomized, un-blinded treatment study in which patients (>78     years) with the use off a heart-lung machine were provided into two study arms.      Patient wit precoating have a filling of the machine with their own blood. In the     comparator arm, a standard priming is used.   "
201958|NCT00491140|"     The primary objective is to identify molecular features predicting response or resistance to     cetuximab   "
155425|NCT01249469|"     Background: Solar lentigines are a common dermatologic condition that manifest as     circumscribed single or multiple brownish macules usually located on sun-exposed skin such as     face, hands or forearms. An effective, safe, daily-use, homecare whitening product may     alleviate the cosmetic concerns for the general population. The efficacy and safety of the     previous generation BEX-2009 (Blanc Expert Spot Eraser, L'Oreal, France), a whitening     cosmetic product containing ellagic acid, salicylic acid, licorice root extract, etc., has     been established in Caucasian and Asian populations with facial solar lentigines.      Objective: The purpose of this placebo-controlled, single-center study is 1) to evaluate the     efficacy of the new generation whitening cosmetic product BEX-2011 (Ultimate Whitening Spot     Eraser, L'Oreal, France) in the improvement of solar lentigines on the dorsum of hands or     forearms, and 2) to evaluate the efficacy of BEX-2011 by harmonic generation microscopy to     obtain information of the epidermal melanin continuum, compared to other standard tools for     melanin measurement.   "
155426|NCT01249456|"     Title of study: An observational, multicenter study on the safety and efficacy of Femara®     (Letrozole) as an extended adjuvant treatment in breast cancer patients who completed     adjuvant Tamoxifen or Toremifen treatment      Objectives:      The major objective of the study is to assess safety and efficacy of Femara® in women who had     undergone resection of a primary breast cancer and subsequently received prior adjuvant     tamoxifen or toremifen therapy for 5 years in real-life condition.      The study aims at the following objectives:        1. To identify unknown adverse reactions, especially serious adverse reactions        2. To evaluate incidence and descriptions of adverse reactions under the routine drug use        3. To identify factors that may affect the safety of Femara®        4. To identify factors that may affect the efficacy of Femara®      Methodology: This will be an open-label, multi-center, single-arm, observational phase IV     study.      Number of centers & patients: Approximately 610 (planned No. of patients for total study     period) patients from 4 centers will be enrolled in this study.      Population: Postmenopausal early breast cancer patients who have finished adjuvant treatment     with Tamoxifen or Toremifen for 5 years after curative surgery as indications described in     local product labeling.      Investigational drug: Femara® will be administered orally as described in dose &     administration of local product labeling up to 3 years.      Study duration: FPFV May. 2006, LPFV Dec. 2011. Study drug will be administered for up to 3     years with renewal of contract on yearly basis.   "
155427|NCT01249443|"     This phase I clinical trial is studying the side effects and the best dose of vorinostat when     given together with paclitaxel and carboplatin in treating patients with metastatic or     recurrent solid tumors and human immunodeficiency virus (HIV) infection. Vorinostat may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used     in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     vorinostat together with paclitaxel and carboplatin may kill more tumor cells.      NOTE: An administrative decision was made by NCI to halt further study of vorinostat in this     specific patient population as of February 1, 2013. No patients remain on vorinostat. Going     forward this study will determine the safety and tolerability of the paclitaxel and     carboplatin combination in this patient population.   "
155428|NCT01249430|"     This phase I trial studies the side effects and best dose of azacitidine when given together     with mitoxantrone, etoposide phosphate, and cytarabine in treating patients with acute     myeloid leukemia that has returned after a period of improvement or does not respond to     treatment. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone, etoposide     phosphate, and cytarabine, work in different ways to stop the growth of cancer cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Azacitidine may help mitoxantrone, etoposide phosphate, and cytarabine work better by making     cancer cells more sensitive to the drugs.   "
155429|NCT01249417|"     The purpose of this research study is to determine whether Dysport® is effective in the     treatment of increased stiffness of the calf muscles and to evaluate the safety of this     treatment in children with Cerebral Palsy. In addition this study will also check whether     Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.   "
155430|NCT01249404|"     The purpose of this research study is to assess the efficacy of Dysport compared to placebo     in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or     traumatic brain injury.   "
155431|NCT01249391|"     Osteoarthritis (OA) is the most common form of arthritis and the hand is the most frequently     affected site.Interphalangeal (IP) joints (the small joints of the fingers) are often     involved causing pain, progressive loss of hand function and deformity. Deviation, or bending     to the side, of IP joints (IPJs) with significant functional and cosmetic consequences for     the individual is common. There are no drugs which can slow the disease process so there is     reliance on symptomatic treatment such as pain relief and hand therapy. Joint thermoplastic     splinting (moulded plastic splints that are custom-made) is employed by hand therapists in     other settings, but to the investigators knowledge no studies have formally investigated the     effect of splinting in IP OA.      By resting inflamed tissues and correcting joint alignment, a beneficial role for splinting     in IP OA is likely. In this study, the investigators want to test whether thermoplastic     splinting of deviated IP joints due to OA will 1) improve joint alignment 2) ameliorate soft     tissue inflammation, and whether as a consequence 3) pain and overall hand function will be     improved.      Adults with hand OA with 'affected' IP joints (symptoms from OA associated with deviation of     the joint on X-ray)will be recruited from a specialist hand osteoarthritis clinic. Initially     this will be for distal IP (DIP) joints. In the intervention group (30 patients), an     'intervention' joint for splinting will be identified as the most painful deviated DIP joint     in the past week leading up to enrolment. Up to 3 other 'affected' DIP joints on either hand     will not be splinted but will be monitored as 'control' joints. In the control group (15     patients), an affected joint will be monitored but not splinted. Assessment of joint pain,     hand function by a hand therapist, deformity (by X-ray)and joint inflammation will take place     at baseline, during and at the end of splinting period of 3 months, and also at 6 months,to     assess whether any changes are persistent. In this way, the efficacy of splinting of IP     joints in OA will be assessed.   "
155466|NCT01248936|"     This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in     patients who have received prior systemic therapy for metastatic melanoma and who have no     other satisfactory treatment options.   "
155445|NCT01249209|"     This study is a pilot project to investigate any effect on these markers in conjunction with     lifestyle changes / conservative treatment. Useful and significant information in this pilot     project is intended to be used as background for further research on this issue in connection     with a doctorate.      What is the effect of two years of outpatient treatment for lifestyle change for weight     markers, waist, BMI, HbA1c, HDL and LDL cholesterol, triglycerides and uric acid in adults     with morbid obesity?   "
155432|NCT01249378|"     In this study, the investigators are interested in investigating how the emulsification state     and amount of fat in a meal can modify the kinetics of postprandial lipemia and inflammatory     outcomes (including endotoxemia) in obese vs lean subjects.      10 lean and 10 obese volunteers will come 3 times (>3 weeks apart) at the investigation     center to receive a standard breakfast containing milk fat (10 g non emulsified, or 40 g non     emulsified, or 40 g finely emulsified). 13C triglyceride stable isotopes will allow to follow     the metabolic fate of fatty acids and calculate lipid oxidation by breath test. Blood     sampling throughout digestion will allow to measure metabolic, lipid and inflammation     parameters. Stool will be analysed to determine lipid losses in faeces and to phenotype     microbiota.   "
155433|NCT01249365|"     This extension study is designed to assess the safety of GSK Biological's HPV vaccine     GSK580299 in female subjects who took part in the primary study NCT00294047 and received the     control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the     subject's age group (26 years and older). This study is thus conducted to enable all women     who received the control placebo in the primary NCT00294047 study to receive the GSK580299     vaccine.   "
155434|NCT01249352|"     The primary objective of this study is to assess the efficacy of nimotuzumab in combination     with chemotherapy and radiotherapy for the treatment of locally advanced esophageal cancer,     comparing it to that of the conventional treatment with radiation and chemotherapy.      The secondary objective of this study is to assess the health-related quality of life for the     nimotuzumab in combination with chemotherapy and radiotherapy regimen, compared to the     standard chemoradiation regimen in the treatment of inoperable locally advanced esophageal     cancer.   "
155435|NCT01249339|"     In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users     will be given repeated doses of four different types of portion snus: General, Catch,     Catch Mini and Catch Dry Mini. Each portion of used snus will be collected and frozen     (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific     nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation     of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco     specific nitrosamines (TSNAs) respectively, will be done for each type of snus.   "
155436|NCT01249326|"     The main objective of the study is to evaluate the protein requirement associated with     postoperative weight loss caused by by-pass (shunt which leads to a certain degree of     malabsorption) or sleeve gastrectomy (more technically conservative with less malabsorption),     through the study of nitrogen balance. The benefit of protein supply easily absorbed and with     high essential amino acids content (proteins fast soluble milk) on protein metabolism and     muscle function will also be studied. Endotoxemia and intestinal flora variations were     measured before and after bariatric surgery.   "
155437|NCT01249313|"     Candidemia is the fourth leading cause of hospital-acquired infection in USA. In CMUH, it     caused 9% hospital-acquired bloodstream infection in 2008 and 2009. In addition to increased     mortality, candidemia also increased hospital stay and cost. There is a trend of increased     cases of candidemia in recent years in CMUH. Early empirical and target treatment can reduce     mortality and shortened length of hospital stay.      In the past, most prior studies in Taiwan dealt with risk factors for mortality rather than     for candidemia and also focused at in vitro susceptibility to antifungal agents. In this     study, the investigators hope to analyze the candidemic cases from 2003 to 2009, estimated     1000 cases. There were some rare Candida species. Therefore, the investigators hope to do     case study for these diseases to provide the epidemiology of candidemia in CMUH. The result     can help clinician in predicting the disease and its outcome. Besides, it also provides the     epidemiology of candidemia in mid-Taiwan.   "
155438|NCT01249300|"     Introduction Patients with stroke may be silent aspirators or at risk for laryngeal     penetration or aspiration because of abnormal oropharyngeal functioning and thus are at risk     for aspiration pneumonia and its serious effects. By providing identification of the     components of the abnormal swallow, and comparing swallowing across tasks, the investigators     may avoid aspiration and can instruct patients on preventative or compensatory swallowing     techniques.      Materials and methods        1. Oral examination-A neurologist and speech pathologist examine the patient's swallowing          function. The patient is interviewed about difficulties with food intake, chewing and          swallowing during meals.        2. Ultrasound examination-Ultrasound creates image of areas inside the body using sound          waves. With the patient in a sitting position, a 3/4-inch transducer (device for          transmitting and receiving sound waves) is placed under the chin to visualize epiglottis          movements during swallowing.        3. Modified barium swallow-While standing or sitting, the patient swallows 1/2 teaspoon of          flavored barium (a radioactive substance) six times (a total of 3 teaspoons), while the          tongue and pharynx (tube leading from the mouth to the esophagus) are scanned and          videotaped at the same time epiglottis movement will be trace with ultrasound. The          barium is given in three consistencies-thin, medium and thick (pudding-like).      The investigators will study the oral, pharyngeal and upper esophageal phases of swallow     using videofluoroscopy and correlate with ultrasound tracing of epiglottis movement in     patients with stroke conditions. Most of the previous studies of swallowing have utilized     diagnostic imaging technique to provide a complete swallowing assessment, but limited     capabilities for screening large population of patients.      INCLUSION CRITERIA: The Stroke Center inpatients and outpatients with known or suspected     dysphagia can be included for study as well as patients who are admitted specifically for     this protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or     choking when eating, shortness of breath during swallowing, food backing up into the mouth or     nasal passage, fever or voice changes after swallowing, pain when swallowing, unexplained     loss of weight.      EXCLUSION CRITERIA: Patients who are severely demented or severely compromised will be     excluded if they do not have sufficient cognitive ability to follow directions.     Non-ambulatory patients will be excluded if they cannot be braced or supported within the     fluoroscopy unit. Highly agitated individuals will also be excluded if they are unable to     remain confined in the equipment.      Analytic Methods The Student t test will be used to analyze the difference in epiglottis     movements during swallowing amongst different phases. Levene's test for equality of variances     will be applied to examine the variability of epiglottis movements during swallowing between     the groups. All statistical analysis will be performed with SPSS.   "
155439|NCT01249287|"     A growing number of studies highlight the potential of stem cell transplantation as a novel     therapeutic approach for stroke in animal model. But the stem cell therapy for chronic stroke     patients has not been well investigated yet. In this study, the investigators will test the     hypothesis that intracerebral peripheral blood hematopoietic stem cell (CD34+) (PBSC)     transplantation induces neuroplasticity in chronic stroke patients. The remyelination of     corticospinal tract in the lesion side, focal increased perfusion and increased cortical     activity in the peri-infarcted area will be monitored by the functional MRI after stem cell     therapy. The investigators study is aimed to find the potential mechanisms of the functional     recovery after stem cell implantation. The investigators also hope to find image surrogate     markers for prediction of patient outcome. The possible surrogate markers will be helpful in     improving the treatment procedure and patient selection.   "
155440|NCT01249274|"     The investigators propose a placebo-controlled, randomized clinical trial that would enroll     50 postpartum women with a history of cocaine abuse or dependence to assess whether     progesterone (100mgs twice daily) decreases postpartum cocaine use.   "
155441|NCT01249261|"     The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on     BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.   "
155442|NCT01249248|"     This is a double blind observational analysis of changes in heart rate variability using PD2i     analyser in competitive athletes during strenuous exercise and competition.   "
155443|NCT01249235|"     The purpose of this study is to determine if patching the eye or a bandage contact lens along     with Tylenol #3 is more effective for pain control following pterygium surgery.   "
155444|NCT01249222|"     Sepsis is one of the most prevalent and fatal diseases in intensive care units     .unfortunately, therapeutic approach to sepsis has remained unchanged for many years.     Nowadays, the role of cytokines in pathogenesis of sepsis is obvious. Continuous elevated     levels of various cytokines in severe sepsis could result in uncontrolled inflammation     status. Breaking of inflammatory cascade may lead to improvement in survival. It seems that     modulation of inflammation is one of the strategic plans to conquest sepsis. Therefore,     elimination of bacterial toxins and pro-inflammatory cytokines from the systemic circulation     by plasmapheresis supposed to be rational approach.      Researchers have done several attempts to clarify the efficacy of plasmapheresis in sepsis     treatment. However because of inconsistent results, routine use of this procedure in patients     with severe sepsis remains controversial.      The aim of the present survey is to determine the effect of plasmapheresis on plasma levels     of main pro-inflammatory cytokines and evaluate its therapeutic efficacy in improvement of     outcome and treatment of severe sepsis.   "
155447|NCT01249183|"     Primary objectives:      To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of     age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.      Secondary objectives:      •Secondary immunogenicity objectives: To describe the immune responses 28 days after     concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age     and older To describe the immune response of VAXIGRIP according to European Medicines Agency     criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)      •Secondary safety objective: To describe the safety profile after vaccination in each group   "
155448|NCT01249170|"     Study to determine if pulmonary/critical care fellows will demonstrate increased competency     in the behavioral skills necessary to facilitate family meetings focused on discussions of     goals of care in the ICU from pre- to post-communication skills training.   "
155449|NCT01249157|"     Positron Emission Mammography (PEM) is a newly developed imaging examination of the breast     that uses a radioactive glucose based tracer, which is a form of sugar attached to a low     radiation agent, to detect cancer cells. The radioactive glucose based tracer is called     fluorodeoxyglucose (FDG), and it is FDA approved. A PEM scanner is able to better detect     cancer cells within the breast, more than a regular PET scanner. The PEM scanner is also FDA     approved. This type of imaging may be able to see the breast cancer before it could be seen     with mammograms and may be as good as or better than breast MRI.      The purpose of this study is to compare the value of FDG Positron Emission Mammography (PEM)     with contrast enhanced Magnetic Resonance Imaging (MRI) of the breast for patients with     breast cancer. This study will also perform special pathology test to compare the FDG PEM and     contrast enhanced breast MRI images with the results from the standard of care breast     surgery. This may teach us more about the biology of each breast tumor.   "
155450|NCT01249144|"     This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to     replace the natural crystalline lens after cataract extraction. The variables compared     include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity     outcomes three months after implantation.   "
155451|NCT01249131|"     This study will be an open-label, randomized, 3-way, 6-sequence crossover study in healthy     participants for determining the relative bioavailability of the tablet formulation to the     capsule formulation and the effect of food on the relative bioavailability of the tablet     formulation.   "
155452|NCT01249118|"     The primary objective of Part 1 of this study is to evaluate the safety and tolerability of     the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to     evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of     GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this     study is to evaluate the safety of GDC-0973 administered orally and intravenously.   "
155453|NCT01249105|"     MK-2206 is a newly discovered drug that may slow or stop cancer growth. This drug has been     used in other research studies, and information from those other research studies suggests     that MK-2206 may help to slow or stop the growth of malignant gliomas. In addition, MK-2206     has the capacity to cross the blood-brain barrier. The blood-brain barrier (BBB) is a     separation of circulating blood and cerebrospinal fluid (CSF) in the central nervous system     (CNS); and although it serves as a protective barrier, it can often interfere with     potentially beneficial treatments reaching the brain successfully. Therefore, the     investigators hope that because MK-2206 can successfully cross the blood-brain barrier, it     will be more effective in patients. The purpose of this study is to see how well MK-2206     works in patients with malignant gliomas and will be conducted in two parts: Part 1 and Part     2.      Part 1 of the study will investigate the effects of MK-2206 on Akt signaling in tumor tissue.     Ten patients with recurrent GBM who require reoperation will receive a short pre-operative     course of MK-2206. After recovery from surgery, patients will resume MK-2206 until disease     progression or the development of unacceptable toxicities. Part 2 of this trial will be     initiated only AFTER analysis of Part 1 data shows drug penetration into tumor tissue; if     there is no significant drug penetration into the tumor and/or there is no reduction of pAkt     levels, progression to Part 2 of the trial will be halted. The primary goal of Part 2 is to     determine the therapeutic efficacy of MK-2206 as measured by 6-month progression-free     survival (PFS6). In Part 2, 40 participants with GBM and 18 with anaplastic glioma will be     treated with MK-2206 weekly at a dose selected on the basis of an ongoing phase 1 study.     Treatment duration will be measured in 4-week cycles. Participants will remain on treatment     until tumor progression, as long as there are no unacceptable toxicities. Responses will be     assessed by clinical examinations every 4 weeks and MRI scans every 8 weeks.   "
155454|NCT01249092|"     Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive     destruction of small bile ducts within the liver that can lead to end stage liver disease and     all its complications.      Although ursodeoxycholic acid (UDCA) is associated with increased survival in many patients     with PBC, there is absence of an adequate response to UDCA in a significant proportion of PBC     patients.      Tumor necrosis factor alpha (TNF-alpha) is a cytokine that plays an important role in the     pathogenesis of PBC. Other fibrosis biomarkers such as tissue metallo proteinase 1 (TIMP-1)     are associated with progression of liver fibrosis in PBC. Pentoxifylline (PTX) is a     methylxanthine derivative that inhibits pro-inflammatory cytokines and also has shown     anti-fibrotic effects in serum of patients with PBC. Furthermore, PTX has well known clinical     and safety profiles. The main hypothesis of this study is that therapy with pentoxifylline     (PTX) will result in improvement of liver disease in PBC patients who are incomplete     responders to UDCA.      The focus of this proposal is on the effectiveness of PTX in improving laboratory parameters     of liver disease and levels of cytokines involved in the pathogenesis of the disease in     patients with PBC.   "
155518|NCT01248247|"     Different people have different biomarkers (chemical markers in the blood that may be     related to your reaction to study drugs). If researchers know about your biomarkers before     you receive treatment, they may be able to prescribe a treatment that is better suited to     your body's specific needs.      The goal of this clinical research study is to learn if drug or drug combinations based on     your biomarkers can help to control NSCLC. The safety of these drug combinations will also be     studied.   "
155519|NCT01248234|"     This study will attempt to show that a combination of drugs, Etomidate and Propofol, provide     a more stable blood pressure when used to put elderly hypertensive patients to sleep than     either drug used alone.   "
155566|NCT01247623|"     Primary objective: Determination of safety and tolerability of GV1001 administration combined     with Temozolomide (based on blood samples and adverse events).      Feasibility of combining active immunisation with Temozolomide treatment. Determination of     immunological response after administration of GV1001 and Temozolomide as measured by     presence of DTH skin test reaction and specific T-cell responses.      Secondary: Evaluation of objective tumour response      The trial is an exploratory study which main objective is to estimate safety and feasibility     of combining active immunisation with chemotherapy. However, the trial may also indicate the     efficacy of the combination.   "
155455|NCT01249079|"     This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications     that propose to enrich pre-existing resources for schizophrenia in the National Institute of     Mental Health (NIMH) Human Genetics Initiative and to apply genomic methods to further the     investigators understanding of the molecular etiology of the disorder. The overarching aims     of this proposal are to quickly and cost-effectively ascertain a large sample of trio     families affected by schizophrenia, and to discover causal variants for the disorder in the     first family-based genome-wide association study (GWAS) of the disorder. In Taiwan, there is     no such kind of policy to support this kind of GWAS study as it is a very expensive study,     including collecting large family samples and genome-wide single-nucleotide polymorphism     (SNP) scanning. The investigators, thus, collaborate with Professor Ming T, Tsuang and his     entended subcontracted researchers to apply for this project. The investigators, the research     team in Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia. Through     additional ascertainment within this framework, the investigators will collect an aggregate     sample with adequate power for detecting in a GWAS those variants that make even small     contributions to the risk for the disorder.      The investigators will meet the overarching goals of this project by accomplishing several     Specific Aims, as follows: 1) Rapidly ascertain schizophrenia trio families from Taiwanese     clinical ascertainment sites; 2) Supplement NIMH Genetics Initiative collections by sending     all clinical data and biomaterials to the appropriate repositories; 3) Assess the association     of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms (SNPs) and their     constituent haplotypes; 4) Analyze quantitative schizophrenia phenotypes such as age at onset     ; 5) Perform a genome-wide survey for copy-number variations related to schizophrenia; 6)     Test for gene-gene interactions (epistasis); and 7) Test for gene-environment interactions,     such as the well-established effect of season of birth.   "
155456|NCT01249066|"     AMP-activated protein kinase (AMPK) is an evolutionally conserved protein kinase that serves     as an energy guardian to help cells adapt to various metabolic stress including hypoxia.     Because the role of AMPK in cancers has not been fully elucidated, in this study we     investigated the expression and activation of AMPK in lung adenocarcinoma (LADC) cells and     tissue.   "
155457|NCT01249053|"     Optic atrophy type 1(OPA1) is a nuclear dynamin-related GTPase, targeted to the inner     mitochondrial membrane, which plays a role in mitochondrial fusion. Mitochondria fusion is     associated with process of apoptosis. . OPA1 plays an important role in the mitochondrial     bioenergetics and mitochondrial networks. The changes in mitochondrial shape and     mitochondrial bioenergetics may be cause of the disease. In this study, we investigate the     expression of OPA1 in lung adenocarcinoma (LADC) cells and tissue.   "
155458|NCT01249040|"     The purpose of this study is to investigate and compare different treatment programs for     frozen shoulder by evaluating changes in pain scale and shoulder range of motion(ROM) before     and after treatment.      The investigators define frozen shoulder as shoulder pain with ROM limitation,shoulder     arthrography demonstration of at least two of the following criteria:(1)reduced joint volume     under 10ml; (2)irregular capsular margin;(3)diminished or absent axillary recess.      Afer define diagnosis of frozen shoulder ,patients are randomly assigned to different     Subgroups for different treatment programs.Each subgroup consists of ten patients.      Each treatment program performed for 6 consecutive courses with each course consists of 6     days.Total 36 treatment days.      The treatment programs and grouping as follow:      Group 1:Physical modalities + therapeutic exercise Group 2:Physical modalities + therapeutic     exercise+ intra-articular injection of steroid Gouup 3:Therapeutic exercise Before     treatment,after each consecutive course (6days) of treatment,and at the end of treatment     program, the investigators evaluate the range of motion and muscle strength of shoulder     flexion,external rotation,abduction and internal rotation. Severity of shoulder pain also     evaluated by pain scale before and after treatment program.      The ROM before and after treatment program is compared by paired t-test.The ROM change before     and after treatment in different groups compared by analysis of variance(ANOVA). The ROM     change after consecutive treatment courses(6 days) are compared by multivariate ANOVA.Pain     scale before and after treatment is compared by paired t-test.   "
155459|NCT01249027|"     This is a prospective, observational, single-arm, open-label, multicenter, postapproval     registry study in China. The purpose of this study is to:        -  Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of          real-world patients receiving the XIENCE V EECSS during commercial use        -  Evaluate patient compliance to dual antiplatelet therapy (DAPT)   "
155460|NCT01249014|"     During surgery body temperature can decrease which can adversely affect how people recover     from surgery. This is a common problem. We aim to reduce the incidence of this drop in body     temperature during surgery by testing the effectiveness of two active body warming devices.     One method is to warm the intravenous fluids that the patients will receive, as they are     being infused. The other method is to use a forced-air warmer. This is a device that is     similar to a blanket that the patient has laid over their upper body during the surgery which     has warm air blown into it. The control group will not have any active warming methods. Study     group 1 will have the intravenous fluid warmer in the pre- and intraoperative period.      Study group 2 will have a forced-air warmer in the intra-operative period as well as the     fluid warmer in the pre- and intraoperative period. We will also observe the neonates' vital     signs following delivery.   "
155461|NCT01249001|"     The primary objective of this study is to compare the absorption of a prepared aprepitant     oral suspension with that of the aprepitant capsule in children being treated with     chemotherapy agents that are likely to cause vomiting.   "
155462|NCT01248988|"     The purpose of this study is to collect safety information following routine vaccination with     Synflorix™ among infants in Korea.   "
155463|NCT01248975|"     The primary objective of this study is to evaluate the efficacy and safety of adding     GSK2190915 300mg or placebo tablets administered once daily to fluticasone     propionate/salmeterol 250/50mcg inhalation powder administered twice daily in uncontrolled     asthmatic subjects > or = 18 years of age over the course of 6 weeks treatment.      The secondary objectives are to undertake an exploratory analysis of the efficacy and safety     of adding montelukast 10mg administered once daily to fluticasone propionate/salmeterol     250/50mcg inhalation powder administered twice daily and to investigate the pharmacokinetics     and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 18 years of age     over the course of 6 weeks treatment.   "
155464|NCT01248962|"     Patients who have this kind of cancer are often treated with several drugs. Carboplatin is     one that seems to work for many treatment cycles. Even though it may work against the cancer,     the patient can become allergic to it. If that happens, they would have to stop taking the     drug. The standard way to give carboplatin is by vein over 30 minutes. The purpose of this     study is to:      Find out if giving carboplatin over three hours can prevent the allergy. See if medicine     given before the carboplatin can help reduce the risk of allergic reactions.      Some patients have been given carboplatin over 3 hours instead of 30 minutes. They had fewer     allergies than we expected. We do not know if this was because of the way they got     carboplatin or because of something else.   "
155467|NCT01248923|"     This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma     (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and     bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF)     support.      This study has 2 parts. In the first part, patients will receive increasing doses of study     drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF     support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the     highest dose of study drug possible that will not cause unacceptable side effects.     Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting).      In the second part of this study, patients will receive the best dose(s) and schedule(s) of     study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first     part of the study and will be followed to see what side effects the combination causes and     what effectiveness the combination has, if any, in treating the cancer. Approximately 42     patients from the US will be enrolled in Part 2 (Active, not recruiting).   "
155468|NCT01248910|"     Older people tend to live a sedentary lifestyle which causes a loss of cardiorespiratory     fitness, impaired postural stability and a increased risk of falls. Social isolation of older     people leads to depression and other mental diseases. However, numerous studies show that     age-related degradation processes and functional limitations can be counteracted by physical     activity. Various studies show that alpine skiing is a complex sport that places demands on     the cardiorespiratory, neuromuscular and sensorimotor systems. With studies providing     evidence to suggest alpine skiing is an appropriate activity for elderly as a     health-enhancing sport, perhaps Alpine skiing could provide the physical activity needed to     counteract age-related degradation processes and loss of function. To date, there is a lack     of long-term intervention studies devoted to this topic. The aim of this study was to monitor     the long-term effects of skiing on the health of older people, as to age-related muscle     breakdown, cardiorespiratory fitness, body stability, general mobility and the overall     psychological state of the subjects.   "
155469|NCT01248897|"     The purpose of this study is to understand how information of 3 specific biomarkers can     provide guidance to physicians in the treatment of erbB2 positive breast cancer patients.   "
155470|NCT01248884|"     This study is designed to evaluate the safety and immunogenicity of new formulations of GSK     Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination     course to healthy infants at 2, 3 and 4 months of age.   "
155471|NCT01248871|"     To compare the renal protective properties of two currently used anaesthetic techniques - a     sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil     combination for anaesthesia in patients undergoing living donor kidney     donation/transplantation.   "
155472|NCT01248858|"     This is a Phase I, open-label, dose-escalation study to characterize the safety,     tolerability, pharmacokinetic profile, pharmacodynamic profile, and clinical activity of the     oral PI3K inhibitor GSK2126458 and the oral MEK inhibitor GSK1120212 dosed in combination in     subjects with advanced solid tumors. The study will be conducted in 2 parts, a dose     escalation phase and a tumor specific cohort expansion.   "
155473|NCT01248845|"     Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory     pattern of various level of assistance delivered by the ventilator in intubated spontaneously     breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist     (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure,     transesophageal EMG signal and transcutaneous EMG signal will be recorded.   "
155474|NCT01248832|"     The study tested the effects of telephone counseling for smokers from three Asian language     speaking groups: Chinese, Korean, and Vietnamese. The specific aims were to: 1) test the     efficacy of a culturally appropriate counseling protocol for smokers calling the California     Smokers' Helpline on the Chinese, Korean and Vietnamese lines, 2) examine whether     intervention effects varied by cognitive and behavioral predictors of cessation success, 4)     examine whether family involvement plays a role in quitting success, and 5) assess     differences in counseling effect across the three ethnic groups.   "
155475|NCT01248819|"     Studies evaluating intraperitoneal local anesthetic instillation for pain relief after     laparoscopic procedures have provided conflicting results. This randomized, double-blind     study was designed to assess the effects of a novel intraperitoneal local anesthetic     administration technique using nebulization on pain relief after laparoscopic     cholecystectomy.   "
155476|NCT01248806|"     The purpose of this study is to offer annual low-dose spiral CT radiological examination for     5 years to 5000 volunteers from the general population who are considered to be at high risk     of developing lung cancer.   "
155477|NCT01248793|"     The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese     patients with ankylosing spondylitis   "
155478|NCT01248780|"     The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese     patients with rheumatoid arthritis.   "
155479|NCT01248767|"     This research aims to study the future of at risk or pathological gamblers seeking     treatment at the University Hospital of Nantes. The study focuses on socio-demographic and     clinical data. It notably aims to study the evolution of these variables according to the     evolution of the gambling behaviours, the step of care, the modality of care, etc   "
155480|NCT01248754|"     The 18F-FDOPA PET tracer is an amino acid analogue that can be used to visualize high-grade     glioma not clearly identified on diagnostic MRI. Use of 18F-FDOPA PET will permit     neurosurgeons to achieve a complete resection more frequently.   "
155481|NCT01248741|"     High Dose Rate (HDR) temporary prostate brachytherapy offers a precise form of dose     escalation for prostate cancer. Needles are placed, the position is confirmed and treatment     is delivered. Previously High Dose Rate prostate brachytherapy was performed under     TransRectal UltraSound (TRUS) guidance but planned with Computed Tomography (CT) imaging     which introduced a source of error through needle displacement while transporting and     repositioning patient. Recently Varian has introduced a one-step procedure where both implant     and planning are based on UltraSound imaging and performed without patient repositioning.     This planning system is approved by Health Canada and is commercially available.      This study will use High Dose Rate brachytherapy to treat 15 men. Treatment will be planned     with TransRectal UltraSound but validated pre-treatment using Computed Tomography imaging.   "
155482|NCT01248728|"     This is a pilot, randomized, placebo-controlled trial of omega-3 fatty acids in autism.     Autism, originally described by Kanner in 1943, is among the most severe of     neurodevelopmental disorders. It is a Pervasive Developmental Disorder (PDD) affecting social     and communicative functions and is also characterized by repetitive behaviors/restricted     interests. It is also frequently accompanied by significant aggression, self-injury,     irritability and hyperactivity, making care for these individuals an even greater challenge     for families or institutional settings. Autism severely impacts the affected individual and     family members, causing life-long functional impairment. In this protocol the investigators     will use the terms autism and autism spectrum disorder (ASD) interchangeably to refer to     Autistic disorder, Asperger Syndrome and PDD-Not Otherwise Specified (NOS).   "
155483|NCT01248715|"     Current guidelines recommend early initiation of empiric antibiotic therapy to cover typical     and atypical bacteria that may cause community-acquired pneumonia (CAP). Influenza antiviral     therapy in patients with suspected or confirmed influenza. However, many clinicians do not     suspect influenza among patients with CAP or other acute lower respiratory tract illness     (LRTI) and often do not test for influenza. Additionally, results from currently available     diagnostic tests for influenza may be delayed and several tests have low sensitivity and will     give false negative results. Thus, anti-influenza treatment for patients with hospitalized     influenza CAP and LRTI is frequently initiated late if at all. There is an association     between delayed time to administration of empiric antibiotic therapy with increased clinical     failure and mortality. As a result, empiric antibiotic therapy for patients with suspect CAP     is begun within 4 - 6 hours of hospitalization. This has recently been demonstrated for     delayed antiviral treatment as well. We hypothesize that, as happens with early empiric     antibiotics for bacterial CAP, a standardized approach of adding early empiric anti-influenza     therapy during the influenza season to hospitalized patients with suspect CAP and LRTI will     improve clinical outcomes of patients with influenza associated CAP and LRTI.      To test our hypothesis we plan a prospective, randomized, multicenter clinical trial of     hospitalized patients with acute LRTI, including suspect CAP, during . If early     anti-influenza medications were not included on the patients admission orders, patients will     be randomized to standard care, including empiric antibacterial therapy as recommended by     ATS/IDSA guidelines plus standard influenza diagnostics and treatment (Standard of care)     versus early initiation of empiric antiinfluenza therapy plus standard care, e.g. empiric     antibacterial (oseltamivir group). The primary study outcome will be development of clinical     failure and selected clinical outcomes during the 30 days after enrollment. Other clinical     outcomes that will be compared between study groups include time to clinical stability,     duration of hospitalization, development of cardiovascular events, re-hospitalization,     short-term mortality (30 days), and long-term mortality (1 year). The secondary study outcome     will be the cost-effectiveness of the intervention.   "
155484|NCT01248702|"     The purpose of this study is to develop and implement a critical pathway to identify patients     with ischemic cardiomyopathy who are candidates for an implantable cardioverter-defibrillator     (ICD). This study will also determine whether the use of the critical pathway for ICDs is     associated with a change in the ICD referral and implantation rate.   "
155485|NCT01248689|"     One important goal in anesthetic management during ocular surgery is to provide adequate     control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients     with glaucoma or a penetrating open-eye injury. Accurate assessment of IOP is particularly     important in infants and children with definite or suspected glaucoma undergoing examination     under anesthesia.      Anesthetic regimens in this surgical field commonly consist of short-acting anesthetic     agents, such as sevoflurane. Sevoflurane is known to reduce the IOP. During pediatric ocular     surgery, the inspired sevoflurane concentration varies continuously and may have an impact     over the IOP that could affect the conduct of surgery. In this study the investigators wish     to evaluate whether variations in sevoflurane concentration do affect the IOP.   "
155486|NCT01248676|"     The purpose of this study is to determine if multi-language patients will find the     multi-language capabilities of the online modules useful for better understanding of the     general information regarding radiation therapy.   "
155487|NCT01248663|"     Pancreaticoduodenectomy (whipple procedure) is the standard operation for tumors of the     pancreatic head, uncinate process, distal common bile duct as well as the papilla of vater.     For reconstruction, pylorus-preservation (PPPD) has been shown to be technically and     oncologically equivalent to the traditional whipple operation. One issue with this technique     is delayed gastric emptying (DGE), which occurs in 25-70% of patients, usually emerging     between day 4 and 14 after surgery. Patients with severe DGE can not only experience     prolonged length of hospital stay, but are also at increased risk for other complications     like aspiration or other issues related to the inability to ingest nutrition.      There is vast retrospective evidence and one prospective study indicating that antecolic     reconstruction of the duodenojejunostomy can improve the rate and severity of delayed gastric     emptying.      The investigators have conducted a prospective randomized trial in order to test this     hypothesis. Patients were randomized to either undergo antecolic or retrocolic reconstruction     after PPPD. On day 10 after surgery, DGE was assessed by clinical criteria. In addition, a     test meal including 1g paracetamol was administered to check for clinically inapparent DGE.     Of these serum samples, kinetics of intestinal peptides like GLP-1, PYY and glucagon was alos     measured.   "
155488|NCT01248650|"     The purpose of this study is to observe pharmacokinetics and safety of nalfurafine     hydrochloride in patients receiving hemodialysis.   "
155489|NCT01248637|"     This study involves the administration of a hypoxia marker, pimonidazole hydrochloride, taken     orally approximately 24 hours before surgical resection of a pancreatic tumor in order to     identify areas of lower oxygen content on tumor samples.   "
155490|NCT01248624|"     Patients with advanced cancer often have numerous physical and psychological symptoms, which     can negatively affect their quality of life. A palliative care team of different health care     professionals (including doctors, nurses, social workers and therapists) specializes in     treating these symptoms and offers support for patients and their families. However,     palliative care teams are currently involved only in the last two months of a patient's life     or not at all.      The main purpose of this study is to determine whether, compared to conventional cancer care,     early involvement by a specialized symptom control and palliative care team in patients with     advanced cancer will be associated with: better quality of life, greater patient and     caregiver satisfaction with care, better symptom control, improved communication with     healthcare providers and improved caregiver quality of life.   "
155527|NCT01248130|"     The primary aim of this study is to examine the efficacy and tolerability of short-term     omega-3 fatty acids monotherapy in youth with Autism Spectrum Disorders (ASD). The     investigators hypothesize that Omega-3 fatty acids will be efficacious in improving the core     and associated features of ASD in youth, and that Omega-3 fatty acids monotherapy will be     safe and well tolerated by youth with ASD. The secondary aim of this study is to examine the     neuropsychological effect of Omega-3 fatty acids monotherapy in youth with ASD. The     investigators hypothesize that omega-3 fatty acids will be efficacious in improving cognitive     functions in youth with ASD.   "
173535|NCT00115310|"     The purpose of the study is to assess the efficacy and safety of NGX-4010 applied for 60     minutes for the treatment of postherpetic neuralgia (PHN).   "
155491|NCT01248611|"     Traditionally cancer pain is treated with long acting opioids such as morphine around the     clock. However, there is no evidence that all patients have a stable pain requiring around     the clock medication. So far opioids for self-administration with a rapid onset of action     have not been available. Recently a nasal formulation of fentanyl (an opioid similar to     morphine) was released in Europe for treatment of breakthrough pain, i.e. an unpredictable     pain with short duration that breaks through the otherwise stable pain controlled with the     around the clock medication. The basic idea is that this formulation may open for patient     controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of     nasally delivered fentanyl. This means that the patient only takes medication when in pain.     This single center feasibility / safety study is the first part of a study to investigate     this alternative cancer pain treatment approach.   "
155492|NCT01248598|"     The purpose of this study is to study the prevalence of EBV, HCMV, HHV-6 in saliva and on the     toothbrush patient with periodontitis.   "
155493|NCT01248585|"     This research is being done because is is not known if dexamethasone can prevent pain flare     (their pain temporarily gets worse before it gets better) caused by the radiation used to     treat painful bone metastases. Using dexamethasone to prevent pain like this has been studied     in a few people and seems promising, but it is not clear if it can decrease the pain or     prevent the pain flare before it happens.   "
155494|NCT01248572|"     The primary goal of this study is to determine the effective lens position (ELP) - or     location an intraocular lens (IOL) sits in the eye - of the Softec HD IOL. A secondary     study goal is to determine if measures of the eye taken prior to surgery can reliably predict     postoperative ELP.   "
155495|NCT01248546|"     The Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will include     women aged 50 to 69 years invited to the population-based mammography-screening program. All     women attending the screening unit will be asked if they want to attend the trial. If so,     they will be informed about the project, the technique, and the additional compression and     radiation dose. All mammographic examinations of women attending the trial will be     independently interpreted by four radiologists. Since the trial is part of the official     Norwegian Breast Cancer Screening Program (NBCSP), the interpretations will be carried out     on-line into the national screening database of the NBCSP. The study will include independent     reading of conventional digital (2D) mammograms, 2D plus computer-aided detection (CAD), 2D     plus DBT, and synthetic 2D plus DBT. There will be a common consensus meeting for all     examinations having a positive score. Recalls and diagnostic work-up will be according to     daily practice at the Oslo University Hospital Ullevaal and the guidelines of the NBCSP.      Outcome measures will use performance indicators for organized screening programs, including     recall rate, false positive scores, cancer detection rate, positive predictive values, and     cancer characteristics for the individual readers of the trial.   "
155496|NCT01248533|"     Male subjects, 65 years of age, living in Oslo, Norway will be invited to be screened for     abdominal aortic aneurysm.   "
155497|NCT01248520|"     A randomized, controlled clinical trial to assess whether text messaging to an outpatient     obstetric population can improve maternal influenza vaccine uptake.   "
155498|NCT01248507|"     COPD patients frequently suffer intermittent exacerbations of their disease characterised by     acute deterioration of symptoms. Acute exacerbations of COPD (AECOPD) are associated with     significant impairment of health status, use of health care resources, poor prognosis and     increased mortality. The development of simple and practical predictive tools would help to     identify COPD patients at greater risk of suffering exacerbations, which is important since     those patients would need more intense and early treatment.      This one-year prospective cohort non-drug study will evaluate several COPD-specific     questionnaires as predictive tools and the presence of cardiovascular comorbidities as risk     factors, for the composite events in study cohorts. The trial duration consists of a     screening period (4-6 weeks) and a follow-up period (12 months), 4 visits in total along the     study.   "
155499|NCT01248494|"     This is an open-label phase Ib multi-institution trial that evaluates the safety     profile/tolerability and preliminary anti-tumor effect of BKM120 (a PI3K inhibitor) and     endocrine therapy combination and BEZ235 (a PI3K/ mTOR inhibitor) and endocrine therapy     combination in postmenopausal patients with hormone receptor-positive metastatic breast     cancer.   "
155500|NCT01248481|"     To evaluate the effectiveness of Glucobay when combined with a basal insulin under daily-life     treatment conditions in a large sample of Korean patients.   "
155501|NCT01248468|"     The main purpose of this study is to compare the efficacy and safety of aspirin,     acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of     migraine.   "
155502|NCT01248455|"     Background:        -  Recent studies have shown that smoldering multiple myeloma has a high risk of          progressing to multiple myeloma, an aggressive type of bone marrow cancer, within 5          years of diagnosis. People with smoldering multiple myeloma have abnormal blood test          results that show a high level of monoclonal protein (M-protein) in the blood and of          plasma cells in the bone marrow. There are currently no known effective treatments to          prevent smoldering multiple myeloma from developing into multiple myeloma, and there are          no known tests for determining whether an individual with smoldering multiple myeloma          will develop multiple myeloma.        -  Certain cells in the immune system, known as natural killer (NK) cells, are active          against multiple myeloma. The experimental drug anti-killer cell immunoglobulin-like          receptor (anti-KIR) has been shown to help NK cells kill multiple myeloma cells.          Researchers are interested in determining whether anti-KIR can be given to individuals          with smoldering multiple myeloma to improve their abnormal blood test results.      Objectives:      - To evaluate the safety and effectiveness of anti-KIR as a treatment for abnormal blood test     results related to smoldering multiple myeloma.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with smoldering multiple     myeloma.      Design:        -  Participants will be screened with a physical examination and medical history, and will          provide baseline blood, urine, and bone marrow samples before beginning the study drug.        -  Participants will receive anti-KIR intravenously for 1 hour, and will be closely          monitored for 24 hours after receiving the first dose. If there are no serious side          effects, participants will receive five additional anti-KIR doses, one every other          month, for a total of six treatment cycles.        -  Participants will have monthly visits to provide additional blood and urine samples, and          may have additional bone marrow biopsies as directed by the study researchers.        -  Participants will have followup visits every 3 to 6 months for up to 5 years after          receiving anti-KIR treatment.   "
155503|NCT01248442|"     In this placebo controlled study the investigators aim to investigate the effect of a 3 month     vitamin D supplementation on parameters of the immune, endocrine and metabolic system in     healthy women and men. Vitamin D. In a pilot study the investigators showed an increase of     certain immune cells, which regulate immunotolerance, the investigators therefore try to     confirm these results with a placebo group. Furthermore the investigators assess the effect     of vitamin D on the glucose metabolism and hormone levels.   "
155504|NCT01248429|"     This study describes the elevation of CPK in patient treated for solid tumors by TKI   "
155505|NCT01248416|"     When treating very short children in puberty we are time-limited, as sex hormones cause the     growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty,     increase height potential, but leave children sexually infantile at a critical time in     development. Human and animal data show that estrogen, in females and males, is a principal     regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs),     which block testosterone to estrogen conversion, in boys with different growth disorders, we     have shown that AIs may have beneficial effects enhancing height potential in growth-retarded     males, without affecting their puberty. However, no direct comparison of the effect of AIs     alone vs. conventional GH treatment has been done to date. This study will assess the effect     of AIs alone, GH alone and combination treatment in enhancing height potential in adolescent     boys with idiopathic short stature.   "
155506|NCT01248403|"     Adult patients with gastric carcinoma which has progressed after initial treatment with a     fluoropyrimidines-containing regimen will be treated with paclitaxel plus RAD001 or plus     placebo. The hypothesis is that patients with RAD001 have significantly prolonged overall     survival compared to patients who are treated with paclitaxel alone.   "
155507|NCT01248390|"     The purpose of this research is to see whether adding a new therapy helps people with brain     injury focus better and think more clearly. You are being asked to participate in this     research study because you have had a brain injury. If you decide to volunteer, you will be     in the study for about six months.As a participant, you will be randomly assigned to one of 2     treatment plans. Randomization is a process like flipping a coin and means you will have a     chance of being assigned to either of the plans. One group will be given an experimental     therapy using a metronome one hour a day, three times a week. A metronome is a device that     produces a steady beat. You will need to keep time with the metronome doing several different     movements. On each beat, you will be given information both through sound and on a computer     screen about whether you were early or late and how far off beat you were. The tempo of the     beat will be at 54 beats per minute, so you will need to process the feedback information     very quickly to adjust your speed up or down to match the beat. The various movements include     things like clapping hands, tapping toes, or alternating between different similar movements.     It is hoped that the metronome will help subjects to concentrate better.   "
155508|NCT01248377|"     This study aims to compare the results of skin testing and ELISPOT assay in patients with a     history of non-immediate reactions to cephalosporins   "
155509|NCT01248364|"     An open-label, phase II study to assess the acute and chronic effects of empagliflozin (BI     10773)on fasting and postprandial glucose homeostasis in patients with IGT and type 2     diabetes mellitus and assess the acute effects of empagliflozin in healthy subjects.   "
155510|NCT01248351|"     The objective of the study is to test the hypothesis whether or not autologous stored     platelets are able to offset the antiplatelet effect of aspirin and clopidogrel as assessed     by state-of-the-art platelet function assays.   "
155511|NCT01248338|"     An impairment of endothelial function plays the central role in the pathogenesis of     cardiovascular diseases and their complications. Most of cardiovascular risk factors are     known to impair endothelial function and the established disease further aggravates     endothelial dysfunction.      The aim of the present study is to investigate the effects of nebivolol or metoprolol     succinate on endothelial function and large artery stiffness.   "
155512|NCT01248325|"     Sixty subjects will take part in this study. The subjects will be randomly assigned in a 1:1     ratio between the two arms of study. (Group A: Solution of Luffa Nasal Operculate 5mg/mL,     Group B: saline).      The subjects will use the study medication or comparative, according to their randomization,     for a treatment period of 3 to 7 days. A follow-up visit will be made 15 days after     initiation of treatment.   "
155513|NCT01248312|"     Hypercapnea is a condition where there is too much carbon dioxide (CO2) in the blood. Carbon     dioxide is a gaseous product of the body's metabolism and is normally expelled through the     lungs (breathed out). Hypoventilation (or respiratory depression) occurs when the ventilation     is inadequate to perform needed gas exchange; therefore resulting in decreased levels of     oxygen and increased levels of carbon dioxide in the blood. It can cause an increased     concentration of carbon dioxide and respiratory acidosis. Obesity is a multi-system disorder,     particularly involving the respiratory (lungs/breathing) and cardiovascular (heart/vessel)     systems. Obesity increases the risks for surgical and anesthetic complications before, during     and following surgery.      Bariatric (weight loss) surgery is becoming a common procedure among the morbidly obese (100     lbs or more above normal weight), with recent studies highlighting the long-term health     implications of surgical weight reduction, to include a decreased risk of hypertension (high     blood pressure) and diabetes (increased sugar in blood). Obese patients are at increased risk     of sleep apnea (stop breathing while asleep) and hypoventilation even without surgery, and     these risks increase following administration of medications typically given during and after     major surgical procedures. Hypoventilation can lead to hypercapnea, sedation (sleepiness),     and acidosis (blood imbalance), resulting in further respiratory compromise (breathing     problems) and cardiac morbidity (heart problems) as well as the risks inherent in     re-intubating (needing to have a breathing tube place down into the lungs) the     obese.Monitoring for hypoventilation can be difficult. Quantitative capnography (measuring     carbon dioxide) is only appropriate for intubated patients (on a ventilator - breathing     tube), and pulse oximetry (clip on finger that measures oxygen levels) does not adequately     detect hypoventilation in patients receiving supplemental (additional) oxygen. Serial     arterial blood gas (blood taken from an artery to measure oxygen level in blood) measurement     is expensive, time-consuming, and painful. Continuous respiratory rate monitoring is     possible, and has been considered the gold standard of apnea detection (seeing stopped     breathing), yet is seldom used. As a result of these limitations, there is currently no     simple, cost-effective, and reliable means of detecting hypoventilation in this patient     population either in the recovery room or inpatient unit. Transcutaneous (across the skin)     pCO2 (t-pCO2) monitoring has been validated as a reliable and reproducible means of measuring     pCO2 in newborn babies, and recently has also been used in adults, primarily in the ICU     (intensive care unit) setting. When compared to standard end-tidal CO2 measurement, t-pCO2     correlates better with pCO2 in the intraoperative period in both thin and obese patients.     SenTec, is the manufacturer of a device used to measure t-pCO2 for this project. This study     is designed to detect the incidence of hypercapnea in morbidly obese post-surgical bariatric     patients in the postoperative period using the SenTec t-pCO2 monitor.      Objective:To determine the incidence of hypoventilation and hypercapnea as measured by     transcutaneous pCO2 monitoring in post-surgical bariatric patients as compared to thin     controls.   "
155514|NCT01248299|"     Interest of continuing systemic chemotherapy or not , after a short initial treatment (6     weeks) in patients who are in response or stable disease(Discontinuation design )of     patients with metastatic oesophageal cancer of squamous cell type      The secondary aims would be to study : toxicity, the overall survival rate, a study of costs     and quality of life.   "
155515|NCT01248286|"     Food products derived from cereal grains constitute a major part of the daily diet of many     Americans . For example, a typical Chinese American eats rice about 9.5 times a week on an     average. However, most of these foods are derived from refined grain. During the refining     process grains are stripped of their bran and germ which results in depletion of several     biologically active constituents including fiber, anti-oxidants, phytoestrogens and minerals.     From observational studies there is evidence for a protective effect of whole-grain foods     with regard to the development of type 2 diabetes. More recently, higher intake of whole     grains was also associated with decreases in insulin resistance - a risk factor related to     the development of type 2 diabetes.      In this randomized study the investigators plan to replicate this beneficial effect of     improving insulin sensitivity in patients with pre-diabetes and go a step further by     exploring the potential mechanisms by which this benefit may occur. The investigators will     assess the effect of consuming a whole-grain-rich diet on levels of advanced glycation     endproducts (AGE), RAGE (receptor for AGE) and markers of inflammation and oxidative stress -     all of which have been shown to play an important role in the pathogenesis of diabetes     mellitus. The investigators will also look for correlations between the levels of these     markers with insulin sensitivity to identify potential mechanisms of pathogenesis.   "
155516|NCT01248273|"     The purpose of this study is to 1) test the safety of the vaccine to find out what effects,     good and/or bad, it has, and 2) to find out if the vaccine stimulates the immune system. The     vaccine in this study will contain several parts. The first part is called an antigen. These     antigens or fingerprints are found on many cancer cells, especially from the ovaries,     fallopian tubes, or peritoneal cavity (inside lining of the abdomen) The purpose of this     study is to see if investigators can help the immune system to recognize that cancer cells     are not normal and should be removed.   "
155517|NCT01248260|"     The purpose of this study is to find out if folic acid prevents of the reduction of fetal     body and brain size in infants whose mothers smoke.   "
155528|NCT01248117|"     Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal     choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved     anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.   "
155520|NCT01248221|"     The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath     test and scintigraphy in healthy subjects and subjects with dyspepsia.      Subjects will eat a standard meal of 2 scrambled eggs, a slice of wheat toast and 8 ounces of     skim milk. The eggs will be double labeled with Technetium-99m (99mTc) sulfur colloid and     13C-Spirulina platensis.      Scintigraphy is a diagnostic technique in which a two-dimensional picture of internal body     tissue is produced through the detection of radiation emitted by a radioactive substance     administered into the body. The location of a standard meal in the digestive system will be     measured by images of the 99mTc sulfur colloid taken at periodic intervals before and after     the standard meal. The 99mTc Sulfur Colloid is approved by the FDA for use in medical     diagnostic procedures.      Spirulina platensis is blue - green algae, which is very similar to the naturally occurring     spirulina sold in health food stores as a dietary supplement. The spirulina platensis has     been labeled with the 13C stable isotope. 13C stable isotope labeling is inherently safe as     1.1% of all carbon in our bodies and in the food we eat is 13C. The presence of the 13C will     be measured by breath samples at periodic intervals before and after a standard meal. The FDA     considers 13C-Spirulina platensis to be investigational for the purposes of this study.   "
155521|NCT01248208|"     With the growing public health concerns of seasonal influenza and H1N1 in the United States,     the primary means by which this can be addressed is with prevention, namely, vaccination     against the influenza virus. The only individuals not able to receive this vaccination in the     primary care provider's office are those patients with egg allergies and, in rare     circumstances, individuals with allergies to other components of the vaccine. Current     guidelines allow for the administration of the influenza vaccine to patients with egg allergy     using vaccines with low egg protein (ovalbumin) content or by using skin testing followed by     a 5-dose desensitization protocol. Since this is impractical to perform in the primary care     office and cumbersome for allergists, many egg-allergic patients simply do not receive the     influenza vaccine, leaving them more vulnerable to the disease and more likely to become a     source of contagion.      Several studies have suggested that influenza vaccination using a 1-2 dose protocol may be     safe. This fact is due in large part to the low ovalbumin (egg protein) content in modern     influenza vaccines. All studies of influenza vaccination in egg-allergic patients have been     done using intramuscular trivalent inactivated influenza vaccine (TIV). However, the     trivalent live-attenuated, cold-adapted influenza vaccine (LAIV), which is delivered     intranasally, has a lower published ovalbumin content than the injectable vaccines,     suggesting that it may also be well-tolerated by egg-allergic patients. According to several     studies, LAIV may be more efficacious than TIV in children.      It is the goal of the investigators to evaluate the safety of immunizing egg-allergic     individuals with the LAIV.   "
155522|NCT01248195|"     The purpose of the study is optimising current treatments in schizophrenia and explore novel     therapeutic options for schizophrenia. The study intends to both address basic, but so far     unanswered, questions in the treatment of schizophrenia and develop new interventions. It is     expected that the project will lead to evidence that is directly applicable to treatment     guidelines, and will identify potential mechanisms for new drug development.   "
155523|NCT01248182|"     The purpose of this study is to determine the bone to skin depth for groups of lean, obese     and morbidly obese patients. This information will be potentially helpful with implant design     for obese and lean patients.   "
155524|NCT01248169|"     The utilization of external cardiohemodynamic patient assessment, applying non-invasive     stick-on contact patches to the mother's neck on either side and chest wall on either side,     enables the practitioner to have information about the patient's cardiac function and     vascular status beyond simply blood pressure and pulse. This information, once collected,     should open the practitioner's eyes to better assess the patient's disease status and her     response to therapy. We will use this information to compare the effectiveness of the two     standard medications used for treatment of maternal high blood pressure.   "
155525|NCT01248156|"     Atrial fibrillation (AF) is the most prevalent heart rhythm disorder in the United States,     affecting 2.5 million individuals in whom it may cause stroke, palpitations, heart failure,     and even death. Unfortunately, therapy for AF is limited. Anti-arrhythmic or rate-controlling     drugs are poorly tolerated, with frequent side effects and do not reduce stroke risk.     Ablation is an emerging, minimally invasive therapy that has attracted considerable attention     because it may eliminate AF. Unfortunately, AF ablation is technically challenging, with a     success of only 50-70% (versus >90% for other arrhythmias) and serious risks. A major cause     of these limitations is that the mechanisms for human AF are not known and thus ablation     cannot be directed to them. As a result, AF ablation is empiric and results in extensive     destruction of the atrium.      This project will perform research to better understand AF and determine if abnormal activity     in small regions or more widespread regions of the heart cause AF. By performing these     studies in patients during clinical procedures, this project may lead to a paradigm shift in     the understanding and treatment of AF.   "
155526|NCT01248143|"     Type 2 diabetes is common in ethnic and, minority groups in developing and developed     countries such as Africans, African Americans, Asians, Native Americans, Hispano-Latinos and     Alaskan indians. A randomized controlled study to assess the efficacy of fermented papaya     preparation and green tea infusates in latent diabetes (individuals newly diagnosed as     diabetics) is proposed. Glycation products from excess glucose autooxidation can chemically     modify DNA causing mutations and cause complex DNA rearrangements. Advanced glycation     end-products which play a role as proinflammatory mediators in gestational diabetes can     accelerate vascular occlusion by quenching the vasodilating agent nitric oxide. Interaction     with high-affinity receptors located on monocytes and macrophages can enhance the production     of free radicals and reactive oxygen/nitrogen species, the secretion of tumor necrosis     factor-α, interleukin-1 and insulin-like growth factor I which can proliferate endothelial,     mesangial and smooth muscle cells and hence contribute significantly to the pathogenesis of     cardiovascular complications. The clinical markers include C-reactive proteins (inflammation     indicators), protein C (markers of reno vascular injury), uric acid, natriuretic peptides,     and the integrity of isolated adipocytes, glucose levels, lipid indices (triglycerides, total     cholesterol, VLDL, HDL and LDL). Given that decreased functional activity of activated     protein C affects the permeability of the glomerular capillary wall and enhances apoptosis of     glomerular endothelial cells and adipodocytes, this has relevance to the pathophysiology of     diabetic nephropathy. A second phase of the study is expected to commence after the first 16     weeks in order to assess the ability of the dietary factors to modulate atheroma formation     and the integrity of drug therapy (upon commencement of treatment)on the prognosis of     diabetes. This will be expected to last up to 3 years.   "
155564|NCT01247649|"     The present study is aimed to evaluate the feasibility of a new noninvasive method to measure     continuous glucose values using electromagnetic radiation.   "
155530|NCT01248091|"     Increasing accessibility of long-acting reversible contraceptive methods, like intrauterine     devices (IUDs), is an important strategy to reduce the risk of unintended pregnancy.     Unfortunately, fear of IUD insertion in women who have not had children is common among     health care providers and women alike, and this limits IUD use. To increase acceptance of     this highly effective contraceptive, there is need to investigate novel, low cost, easily     applied and accessible techniques to improve the insertion experience. This is a pilot study     to evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an     intervention to improve the IUD insertion experience for both patient and provider.   "
155531|NCT01248078|"     In this prospective, randomized, placebo controlled trial the investigators were able to     demonstrate the usefulness of prophylactic cefazolin in elective caesarean section versus     placebo, irrespective of the timing of administration, ie before skin incision or after     umbilical cord clamping   "
155532|NCT01248065|"     The purpose of the study is to find out if taking vitamin D in addition to an asthma     controller medication helps to prevent worsening of asthma symptoms and asthma attacks.   "
155533|NCT01248052|"     This is a two part study (Parts A and B), the purpose of which is to determine the safety of     LY2979165 in healthy people, and any side effects that might be associated with it, and to     understand how the body handles LY2979165. In addition, Part B, will also look at levels of     LY2979165 in spinal fluid. Doses investigated will be in the range of 20-1000 mg.   "
155534|NCT01248039|"     This study wish to show if the preoperative level of pain, function or activity for hip and     knee arthroplasty patients has any predictive value of the time it takes to fulfill the     well-defined discharge criteria.   "
155535|NCT01248026|"     The role of low-density lipoprotein cholesterol (LDL-C) in the pathogenesis of cardiovascular     disease (CVD) and the clinical benefit of lowering LDL-C in high-risk patients have both been     well established. The key contribution of the intestine to whole body cholesterol homeostasis     and thus to regulating plasma cholesterol concentrations has also been recognized over the     last years. It is now clear that cholesterol homeostasis and hence plasma LDL-C     concentrations are maintained by a fine-tuned balance between intestinal cholesterol     absorption and endogenous cholesterol synthesis.      Cholesterol is a highly hydrophobic molecule and for that reason, its absorption is almost     entirely dependent on its solubilizing capacity in bile acid micelles within the intestine.     Recent in vitro studies from our laboratory have shown that buttermilk, a unique by-product     of butter manufacturing resulting from the churning of cream, has a strong inhibitory effect     on cholesterol micelle solubility. This phenomenon is likely due to the presence of unique     milk fat globule membrane (MFGM) fragments present in buttermilk that are produced during the     manufacturing of dairy cream into butter. Most of the work done so far on the subject has     focused on phospholipids purified from MFGM, while overlooking the complex and entire MFGM     mixture of bioactive proteins and polar lipids found in buttermilk. To the best of our     knowledge, no study has yet documented the impact of whole buttermilk on plasma cholesterol     concentration in human.      The general objective of this research project is to investigate for the first time the     impact of buttermilk on plasma cholesterol and other risk factors for CVD in humans. More     specifically, we propose to investigate the impact of buttermilk consumption on plasma LDL-C     and other CVD risk factors as well as on plasma surrogates of cholesterol absorption and     synthesis.   "
155536|NCT01248013|"     The primary goal of the study was whether gut focused hypnotherapy, in a group format, was     successful in reduction of symptoms in patients with irritable bowel syndrome. The secondary     goal was to see if any outcome predictors could be determined.   "
155537|NCT01248000|"     Positron Emission Tomography (PET) represents a step forward in the definition of response to     therapy in patients with Hodgkin Lymphoma (HL). In particular the use of PET for the early     assessment of response has been described as the most important tool for predicting the risk     of disease progression. As no data are available to support the use of early assessment of     response for adapting and modifying subsequent treatment, the use of PET should be limited     only to patients enrolled in clinical trials. Irrespective of recommendations PET scanning is     included in the current management of patients with HL at baseline, mid treatment, end of     treatment, and follow-up. So far no study has been performed to verify how PET is currently     used in the clinical setting and to assess if and how results of PET scanning are used for     supporting treatment and clinical decisions.   "
155538|NCT01247987|"     The purpose of this study is to determine if cryopreservation at the blastocyst stage     followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear     oocytes followed by post-thaw extended culture (PTEC), and blastocyst transfer. Effectiveness     will be measured by the rate of ongoing pregnancy at 10 weeks gestation.   "
155539|NCT01247974|"     This is a multi-center, prospective, randomized and controlled clinical trial comparing the     safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of     new onset postoperative atrial fibrillation by circumferentially reconstructing the normal     pericardial anatomy following isolated, first-time, CABG procedures compared to subjects that     do not undergo pericardial closure. This trial will be conducted at up to 20 clinical sites     in the U.S.   "
155540|NCT01247961|"     This pilot trial will evaluate the following in patients with acute pancreatitis:        1. Safety profile of early treatment with intravenous dexamethasone        2. Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis        3. Provide preliminary data on potential impact of early treatment with steroids on          clinical outcomes   "
155541|NCT01247948|"     The purpose of this study is to investigate the difference of the accuracy and safety between     traditional spine surgery and computer assisted navigation system spine surgery.   "
155542|NCT01247935|"     To compare the effectiveness of acupuncture and transcutaneous electrical nervous stimulation     (TENS) in reducing patient's discomfort during colonoscopy   "
155543|NCT01247922|"     Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205     and either progressed while on study or discontinued due to unacceptable toxicity related to     etoposide were allowed to participate in this study to assess the safety profile of     single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.   "
155565|NCT01247636|"     The purpose of this randomized controlled trial is to evaluate the effectiveness of an     exercised-based programme developed for older people admitted at a geriatric outpatient     clinic and to see if a home-exercise program enhances the effect. The outcomes considered is     health-related quality of life, balance-self confidence, balance and mobility.   "
173733|NCT00108017|"     This study is comparing 2 medications for glaucoma and how effective they are at controlling     glaucoma over the course of an entire day.   "
155633|NCT01246752|"     Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of age     in intermediate risk, after first complete response in comparison to standard consolidation     chemotherapy   "
155544|NCT01247909|"     This study aims to improve the outcome of infants (<2 months) with severe sepsis and     meningitis at the Queen Elizabeth Central Hospital, Blantyre, Malawi.      Currently WHO recommends the treatment of infant severe sepsis and bacterial meningitis with     14 to 21 day course of penicillin and gentamicin as first line. The second line treatment is     cefotaxime or ceftriaxone.      Severe bacterial infections are common in infants under 2 months of age and the mortality is     very high (~50%). There are several reasons for this; one is that the first line antibiotics     used are no longer as effective as they used to be. Bacterial resistance to the first line     antibiotics has increased and some infections especially of the central nervous system may     only be partly treated and not eradicated by present therapy. First line treatment is cheap     and available but requires 4 injections a day, for at least 14 days, a total of 58     injections. Many mothers find this number too much and abscond. The investigators second line     therapy is ceftriaxone which is also available and cheap and the advantage of being given as     a daily injection. The disadvantage is that it can cause (reversible) jaundice particularly     in premature babies and it must not be given with calcium products. The investigators do not     give calcium to the investigators infants as the investigators cannot routinely check     electrolytes. All the most common causes of bacterial meningitis in this age group in the     investigators setting are sensitive to ceftriaxone.      The investigators wish to undertake an open randomized trial of penicillin and gentamicin v     ceftriaxone as first line treatment for infant meningitis. The investigators are able to     monitor for side effects.      The investigators hypothesise that the ceftriaxone arm will have 20% less deaths that the     penicillin and gentamicin group.   "
155545|NCT01247896|"     PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The     purpose of the study is to evaluate the safety and tolerability of PF-05190457 after     administration of a single dose to healthy volunteers and to evaluate the plasma drug     concentrations after single dose in healthy volunteers.   "
155546|NCT01247883|"     This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when     respectively given orally as a single tablet dose and a single dose of a solution.   "
155547|NCT01247870|"     The purpose of this study is to determine the effect of a tablet medication, called     metformin, in flare-ups (exacerbations) of chronic obstructive pulmonary disease. The     investigators believe that metformin may effectively control the blood sugar level during     COPD exacerbations. This is important because there is evidence that a high blood sugar level     during exacerbations may be linked with a worse prognosis. The investigators also think that     metformin may have other potentially useful effects on inflammation, antioxidant levels, the     effectiveness of steroid treatment, and recovery.   "
155548|NCT01247857|"     Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after     laparoscopy. Preoperative compared with postoperative administration of analgesia remains     controversial. This randomized, double blind, placebo-controlled trial compared the analgesic     efficacy of preoperative with postoperative peritoneal ropivacaine nebulization in patients     undergoing elective laparoscopic cholecystectomy.   "
155549|NCT01247844|"     The objective of this research study is to evaluate the safety and acceptability of the Shang     Ring method of medical male circumcision. The Shang Ring is a new circumcision device with a     potential role in the safe and cost-effective delivery of circumcision services. The device,     developed in China, consists of two concentric plastic rings. Following a ring penile block,     the smaller ring is fitted at the base of the coronal sulcus. The foreskin is everted over     the inner ring and the larger outer ring is secured over the inner ring. The foreskin is     excised and several nicks are made on the incision line to prevent formation of a     constricting, circumferential scab. No suturing is required.      In this study, the investigators will evaluate wound healing of men randomized to removal of     the Shang Ring at one of three different points in time (Days 7, 14 or 21). Leaving the     device on for 14 or 21 days constitutes extended wear of the device.      Sites: Homa Bay District Hospital, Nyanza Province, Kenya   "
155550|NCT01247831|"     The purpose of this study is to examine the influence of selective laser trabeculoplasty     (SLT) on ocular rigidity in glaucoma patients.   "
155551|NCT01247818|"     PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical     administration to the skin, and is being studied for the treatment of cutaneous skin     disorders, specifically psoriasis and atopic dermatitis. This multicenter phase 2 study of     subjects randomized sequentially by center to one of four treatment cohorts will assess     efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque     psoriasis.   "
155552|NCT01247805|"     The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10     Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil     Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet     in Healthy Volunteers.   "
155553|NCT01247792|"     The care of patients with sepsis-related organ failure on the intensive care unit (ICU) often     includes end-of-life decision (EOL-D) and communication of such decisions to relatives. This     increases the psychological burden for caregiver and relatives.      The investigators intend to assess the prevalence and impact of EOL-D on ICU care-givers and     relatives (before) and to use this data to develop and implement standard operating     procedures (SOPs) for improved decision-making and communication of these decisions     (after).      The hypothesis is that an improved communication strategy will reduce symptoms of burnout in     caregivers and symptoms of anxiety and depression in relatives.   "
155554|NCT01247779|"     The purpose of this study is to compare perioperative morbidity of coelioscopy versus     robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.   "
155555|NCT01247766|"     The purpose of this study is to compare the incidence rates of infection, malignancy and     death among patients with rheumatoid arthritis who are treated with abatacept and those who     are treated with other anti-rheumatic medications for rheumatoid arthritis.   "
155721|NCT01245595|"     Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass     (the heart-lung machine). Approximately 35 to 50% of these children will have acute kidney     injury, or damage to the kidneys, after the procedure. We currently have few medications to     prevent this kidney injury. The hypothesis of this study is that giving aminophylline after     heart surgery can decrease the acute kidney injury.   "
155556|NCT01247753|"     The prevalence of Gestational Diabetes Mellitus (GDM) in Australia is approximately 5%-8%,     with up to one third of all parous women who develop type 2 diabetes having a previous     history of GDM. Research to determine strategies to delay or prevent the development of or     progression to diabetes is vital, particularly in population groups that are at higher risk,     such as GDM, and overweight women (BMI>=25). Currently, follow-up or post-partum support for     women who develop GDM is limited to advice to complete a 6 week post-partum oral glucose     tolerance test to exclude overt diabetes, to be repeated annually. A pilot randomized     controlled trial (RCT) conducted at Mater Mothers Hospital suggested that a post-partum     intervention designed to increase physical activity in women with previous GDM may be     feasible. A recent study in the United States recruited women with recent GDM into an RCT     where the control group received usual care and the intervention group received a web based     walking program. Although the results of this study are limited, they did show an increase in     pedometer steps/day between baseline and end of study. Dietary intervention has been proven     to increase probability of weight loss, so a strategy of combining both a pedometer and     nutrition based program may prove to be more successful for long term improvement of a     healthy lifestyle to prevent type 2 diabetes.      Study hypothesis: A pedometer based intervention to encourage physical activity, combined     with nutrition coaching in women with recent GDM and BMI >= 25 will result in increased     weight loss, improved insulin sensitivity and increased physical activity when compared with     standard care.   "
155557|NCT01247740|"     The purpose of the study is to investigate the efficacy and safety of a convenient     3-chamber-bag containing aminoacids, glucose and lipid emulsion (LCT/MCT 20%) compared to a     conventionally compounded monobag for parenteral nutrition.   "
155558|NCT01247727|"     National Taiwan University Hospital is the leading center for care of patients with     extracorporeal membrane oxygenation (ECMO). The predictable factors associated with outcomes     are still lacking in patients with the ECMO support. The aim of this study is to collect the     electrical signals stored in the monitor of intensive care units (ICUs), which are analyzed     by the bio-informatics software. The pre-, peri-, and post-ECMO heart rate variability,     including linear and non-linear analysis is calculated to address the association with     outcomes of patients with ECMO. In addition, we collected the demographics, body temperature,     respiratory rate, and blood pressure to investigate the causes of heart rate variability.   "
155559|NCT01247714|"     The hypothesis of the proposed trials is that the regular intake of a specific diet designed     for enteral nutrition of type 2 diabetic patients results into a better nutritional status.     Thus, the aim of the study is to scientifically evaluate the healthy effects of the     administration of an enteral complete diet for diabetic patients (T-Diet plus Diabet).   "
155560|NCT01247701|"     In this study, the investigators will use busulfan and cyclophosphamide (BuCy) backbone with     the addition of fludarabine as the preparative Stem Cell Transplant (SCT) regimen. As an     attempt to improve engraftment rate and reduce infections, the investigators are going to     incorporate fludarabine in the conditioning regimen. The use of a BuCy backbone has been     widely used and comparable to total body irradiation and cyclophosphamide (Cy/TBI) regimen.      Encouraging data on adding fludarabine to the SCT regimen have been reported. A     fludarabine-based, conditioning regimen, with adequate immunosuppressive activity could     conceivably allow engraftment of stem cells from alternative donors in hematologic     malignancies patients with acceptable engraftment rates and low transplant-related mortality.     Regimen-related toxicity is believed to be a major contributing factor to GVHD. Therefore     this approach may also lead to reduced GVHD, as some investigators have suggested.      In an attempt to decrease the rate of viral infection and reactivation, the investigators     will avoid ATG (Thymoglobulin) / Campath (anti-CD52), and instead administer Mycophenolate     Mofetil (MMF). The addition of fludarabine should compensate any increase risk of graft     failure with the removal of the ATG/Campath. The investigators anticipate that the removal of     ATG/Campath will facilitate immune reconstitution more efficiently after receiving a UCBT.   "
155561|NCT01247688|"     The purpose of this study is to determine the safety and effectiveness of UCBT to treat     patients with lymphoid hematological diseases and to see if this treatment can decrease the     incidence of leukemia relapse, GVHD and infections.      These patients have a type of blood cell disorder that is very hard to cure. This treatment     that is being used in this trial is known as a stem cell transplant. This treatment might     help the patient live longer without the disease. It uses much stronger doses of drugs and     radiation to kill the diseased cells that could be given without the transplant. We also     think that the healthy cells from the donor may help fight any diseased cells left after the     transplant.      For the transplant to take place, we will administer stem cells from a 'donor' whose cells     best 'match' the patient's. In this study umbilical cords will be the source of the stem     cells. Before the transplant, two very strong drugs plus total body irradiation will be given     to as preconditioning. This treatment will kill most of your blood-forming cells in the bone     marrow. The patient will then get then healthy stem cells.      If the patient has the disease in the central nervous system (CNS), they will receive     radiation to the head and spine before starting the conditioning. This is to try to get     disease control in the CNS. Radiation will not be given for children under 2 yrs old.      Currently, many umbilical cord blood units are available in public banks for transplantation     in patients lacking bone marrow donors. UCB transplants (UCBT) may offer several advantages     over adult bone marrow or peripheral blood stem cell transplants, including:        1. rapid availability,        2. absence of donor risk,        3. low risk of transmissible infectious diseases,        4. low risk of acute GvHD (Graft vs. Host Disease)      The three main causes of death after umbilical cord blood transplantation for these kind of     disorders are graft failure, infection and disease relapse.      In this study we are trying to address these three problems:      To help improve engraftment we will add the drug Fludarabine to Cytoxan and total body     irradiation. Fludarabine is a very strong medicine. We will try to decrease infections and     reduce leukemia relapse by using fludarabine instead of antithymocyte globulin (ATG).   "
155562|NCT01247675|"     This study investigates the safety, tolerability, pharmacokinetic profile (PK), and     pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared     to one dose-level of an approved daily human growth hormone product over a period of 4 weeks     (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone     Deficiency.   "
155563|NCT01247662|"     Autism spectrum disorder (ASD) is a pervasive neurodevelopmental disorder with prominent     reciprocal social and communication impairment and restricted repetitive behavior or     interest. ASD is a highly heritable disease with tremendous impact on individuals, families,     and society. In addition to the interview instruments, self-administered rating scales are     commonly used in screening, assessment of symptoms' change, and evaluation of intervention     effects. The Social Responsiveness Scale, the Childhood Asperger's Syndrome Test, and the     Autism Spectrum Quotient are internationally widely used rating scales measuring autistic     traits in both clinical and community samples in western counties. Establishment of     internationally-recognized reliable and valid instruments is not only useful for clinical     screening, but also helpful in future functional outcomes, neurocognitive, genetic and brain     imaging studies.   "
155567|NCT01247610|"     Attention deficit/hyperactivity disorder (ADHD) has been recognized as a common (5-8%),     early-onset, long-term impairing, heterogeneous neuropsychiatric disorder with high     heritability. Due to its lifelong impairments up to adulthood, adult ADHD has drawn much more     attention in Western studies in the past decade; however, there has been no such study in     Asian countries. The ultimate goals of this longitudinal follow-up study are to investigate     the outcomes of a cohort of children with attention-deficit/hyperactivity (ADHD) and their     healthy controls at young adulthood as the primary aim; and to test whether structural and     functional brain connectivity can be endophenotypes of ADHD, to localize the brain area that     are corresponding to methylphenidate treatment effects, and to identify the genetic variants     corresponding to the persistence of ADHD, treatment effect of methylphenidate, neurocognitive     dysfunction, and structural and functional dysconnectivity in the brain as the secondary     aims. With the accomplishment of these goals, this study will provide the first-hand data on     adult ADHD in non-western countries, and will be one of few world-class studies on the topics     of neurocognitive and imaging genomics on adult ADHD.   "
155568|NCT01247597|"     Background:      - Pleuropulmonary blastoma (PPB) is a rare fast-growing lung tumor that is associated with     other, rare tumor types. Most cases of PPB appear in children younger than 6 years of age.     Recently, it has been shown that this condition can be inherited (e.g., mutation of the     DICER1 gene). Researchers are studying both clinical and genetic aspects of this newly     described condition. They are interested in collecting further medical history and genetic     information on individuals and close relatives of individuals who have PPB or other rare     associated tumors.      Objectives:      - To study individuals with a personal or a family history of pleuropulmonary blastoma (PPB)     or other rare tumors that can be associated with PPB (e.g., cystic nephroma, nasal     chondromesenchymal hamartoma, ovarian Sertoli-Leydig cell tumors, ocular medulloepithelioma).      Eligibility:        -  Individuals who have been diagnosed with PPB and/or PPB-related tumors.        -  Close blood relatives (e.g., parents, siblings, grandparents) of individuals who have          been diagnosed with PPB and/or PPB-related tumors.      Design:        -  Interested participants can enroll or inquire about this study by calling          1-800-518-8474.        -  Participants will be asked to complete family history and medical history          questionnaires. They will complete the questionnaire if they are at least 18 years of          age, or another person will complete the questionnaire if the key family member is too          young to do so on his or her own.        -  Participants will be asked to sign a medical record release form to allow researchers to          examine detailed medical history information.        -  Participants may be asked to have a physical examination and imaging studies, provide          blood and saliva samples, or provide tumor tissue from prior biopsies or cancer          surgeries.        -  Annually, participants will update the family history and individual information          questionnaires to document important changes in medical history, and will also update          the medical record release form. Participants may be asked to provide additional cheek          lining cells and/or blood samples, as well as tumor tissue from any new or planned          biopsies or tumor surgeries.        -  Treatment will not be provided as part of this protocol.   "
155569|NCT01247584|"     RATIONALE: Studying bone marrow samples from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in samples from young patients with acute     myeloid leukemia.   "
155570|NCT01247571|"     This phase II trial studies how well pazopanib hydrochloride works in treating patients with     uterine cancer that has come back or has not responded to treatment. Pazopanib hydrochloride     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Pazopanib hydrochloride may also stop the growth of uterine cancer by blocking blood flow to     the tumor.   "
155571|NCT01247558|"     This study will be an observational cohort study utilizing administrative claims data with     100 patients randomly selected taking Metanx® meeting the inclusion and exclusion criteria     and 400 propensity score matched patients meeting the same criteria to serve as a control     cohort for analyses. This data includes medical, and pharmacy claims from the HealthCore     Integrated Research Database for claims submitted during the time period of 01/01/2002     through 06/30/2007.   "
155572|NCT01247545|"     Coronary heart disease (CHD) is the leading cause of death in the UK, accounting for 124,000     deaths (2006) and costing the UK economy over £7.9 billion a year. Patients with severe CHD     are usually treated by coronary artery bypass graft (CABG) surgery, the risks of which are     increasing due to older and sicker patients being operated on. New treatment strategies are     therefore required to improve health outcomes in these high-risk patients undergoing CABG     with or without valve (CABG±valve) surgery.      The hypothesis tested in this research proposal is that remote ischaemic preconditioning     (RIC), a virtually cost-free, non-pharmacological and simple non-invasive strategy for     reducing the damage to the heart muscle at the time of surgery, improves health outcomes in     high-risk patients undergoing CABG±valve surgery.      In this research project, 1610 high-risk patients undergoing CABG±valve surgery will be     recruited via 28 UK hospitals performing heart surgery. Patients will be randomly allocated     to receive either RIC or control. For RIC, a blood pressure cuff will be placed on the upper     arm to temporarily deprive it of oxygen and nutrients, an intervention which has been shown     in the investigators pilot studies to reduce damage to the heart muscle by up to 40% during     CABG±valve surgery. The investigators will determine whether RIC can improve health outcomes     in terms of better patient survival, less heart attacks and strokes, shorter hospital stay;     less damage to the heart, kidney and brain during surgery; better heart function post-surgery     and less chance of developing heart failure; better exercise tolerance and quality of life.   "
155584|NCT01247389|"     Incisional hernia (IH) is a common complication of midline laparotomy. Despite the hope that     laparoscopic colon resection would result in fewer incisional hernias, prospective studies     demonstrate a similar incidence to open surgery. Observational studies suggest that the rate     of incisional hernia after laparoscopic colon resection may be reduced with the use of a     transverse compared to a midline extraction incision. However, no randomized trails are     available, and a midline extraction incision for hemicolectomy remains the standard current     approach. The investigators hypothesize that the use of a lower abdominal transverse muscle     splitting incision for specimen extraction in laparoscopic colon surgery will result in fewer     incisional hernias compared to a midline periumbilical extraction incision.   "
155786|NCT01244711|"     The hypothesis of this study is that symptoms of anxiety, depression and insomnia; and     indices of psychosocial function will all improve, while BZ use will decrease significantly     during a twelve-week trial period of substituting quetiapine for benzodiazepines.   "
155608|NCT01247077|"     Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from     weight loss, increased heart rate and stress intolerance. Some patients have difficulties in     regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin,     suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory     antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in     western Europe. This compound has important function in thyroid hormone metabolism and on the     immune system. It is not known whether addition of selenium affects the well being of     patients with Graves´thyrotoxicosis. The subject of this study is to investigate this   "
155573|NCT01247532|"     The purposes of the proposed study are (1) to collect data on the feasibility of offering     Mindfulness-Based Stress Reduction (MBSR) as an intervention to reduce fatigue and     psychological distress in cancer patients who are not in active treatment for their cancer     and (2) to estimate effect sizes of the intervention for fatigue, depression, anxiety, and     sleep disturbance. The investigators also will obtain preliminary effect sizes of the degree     to which the intervention increases mindfulness, and the investigators will evaluate dosage     effects. Findings will suggest whether a future randomized controlled trial with     cancer-related fatigue (CRF) as the primary outcome is feasible and warranted.      Participants will be randomly assigned to either the MBSR intervention arm or to a wait-list     control arm. The MBSR intervention will consist of a weekly 2-hour class to be held for seven     consecutive weeks in the Indiana University Simon Cancer Center Pavilion; the class on week     six will be extended to a 3-hour retreat. Participants will be invited to engage in daily     home practice of meditation and other mindfulness exercises. All participants will complete a     series of self-report questionnaires prior to the start of the classes, immediately following     the end of classes, and 1 month after the class ends. Those in the intervention arm will     begin the MBSR class the week after enrollment; the control group will be offered the same     7-week program after 1-month post-intervention follow-up assessments are     completed—approximately 13 weeks after enrollment.      Primary Aim 1: Obtain preliminary RCT effect sizes for changes in fatigue of an MBSR     treatment group compared to a wait-list control group.      Hypothesis 1: Immediately post-intervention (T2), improvements in fatigue compared to     pre-intervention (T1) will be greater in the treatment group than the control group.      Hypothesis 2: At 1 month post intervention (T3), improvements in fatigue compared to     pre-intervention (T1) will be greater in the treatment group than improvements in the control     group.   "
155574|NCT01247519|"     The investigators will perform and evaluate a post-hospitalization telecare system for     compensating the discontinuity from the hospitalist care system.   "
155575|NCT01247506|"     The purpose of this study is to identify different genetic features in hepatocellular     carcinoma. It will assist in predicting individual risks of disease progression and would     help to clarify pathophysiological mechanisms of HCC.   "
155576|NCT01247493|"     A phase II clinical trial evaluating the efficacy and tolerability of induction and     consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin     (modified-FLAI) in the elderly patients with acute myeloid leukemia.   "
155577|NCT01247480|"     Major Aims of study:        1. To create a gene expression-based prognostic device that complements or exceeds the          prognostic utility of conventional biomarkers of breast cancer outcome.        2. To identify one or more clinical subgroups of patients for which the prognostic device          outperforms, or substantially adds to, the prognostic performance of conventional          markers that currently determine therapeutic strategies.      Sub-Aims of study:        1. Assess the prognostic value of the multiple gene expression signatures, alone and in          combination, using a large cohort of breast cancer patients for which pathology,          treatment and outcome is available. A training and testing design is proposed.        2. Evaluate the utility of a prognostic device that measures gene expression levels from          formalin-fixed paraffin-embedded specimens (FFPEs) of primary resected tumors. The          investigators will utilize the Affymetrix Quantigene 2.0 Assay and/or the Illumina          BeadXpress VeraCode DASL Gene Expression Assay (FDA-approved IVDMIA.)        3. For specific clinical subgroups of patients/tumors, the investigators will          mathematically identify additive or synergistic prognostic relationships between genes          and gene signatures that, in combination, will yield maximal risk prediction (distant          metastases-free survival) for patients.        4. Compare the prognostic utility of the investigators device to that of the conventional          prognostic variables that are currently used to determine therapeutic strategy.        5. Incorporate the prognostic signatures into a practical prognosis algorithm that seeks to          include conventional measures of outcome such as tumor size, histologic grade, nodal          status, patient age, or Nottingham index, etc.      The investigators hypothesize that adequate quality and quantity of tumor RNA may be     extracted from archival paraffin-embedded tumor specimens for gene expression profiling, and     that archival tumor-derived genomic signatures may be used as prognosticators or predictors     in breast cancer.   "
155578|NCT01247467|"     A number of prognostic and/or predictive genomic signatures for breast cancer have been     developed by Genome Institute of Singapore (GIS). In the past 1 year, GIS has developed     protocols and methods to conduct expression assays from formalin-fixed, paraffin-embedded     (FFPE) tumor specimens. A study on 800 tumor samples is planned to analyze these gene     signatures and compare them with conventional clinical prognosticators and predictors. As the     investigators plan to use archival tumor samples that dates back to the 1990s, the aim of     this pilot study is to first analyze 10 anonymized samples to determine the feasibility of     running these assays on old archival blocks. The information generated will help us determine     whether very old samples (diagnosed before 2000) may be selected for the actual study.   "
155579|NCT01247454|"     There will be no significant decrease in the use of low dose acetylsalicylic acid (ASA)     therapy for primary prevention across the three intervention arms from baseline to completion     of the project.      There will be no significant differences in the percentage of patients with diabetes mellitus     greater than 44 years of age on low dose ASA therapy for primary prevention across the three     arms of the study using repeated measures from baseline to completion of the project.   "
155580|NCT01247441|"     The Breast Cancer Registry aims to collect clinical data of all breast cancer patients     diagnosed and/or treated in the National University Hospital, with the goal of understanding     risk factors, presenting symptoms, diagnosis, treatment, and outcome data of breast cancer in     Singapore. This information will contribute to improving management of breast cancer     patients.   "
155581|NCT01247428|"     The DESSOLVE I clinical trial is to assess the safety and performance of the     sirolimus-eluting MiStent SES.   "
155582|NCT01247415|"     During the 2009-2010 immunization campaign against pandemic H1N1, some people reported having     allergic-like reactions (anaphylaxis(a shock-like reaction), hives, swelling, etc.). A     vaccine allergy may be more or less severe or intense. Patients may have skin reactions (rash     with or without itching), respiratory problems (cough, spasm of the airways), angioedema     (swelling) of various body parts (face, eyelids, throat etc.) and circulatory problems (low     blood pressure or shock). Anaphylaxis is a severe allergic reaction that can sometimes be     fatal. Other people vaccinated against pandemic H1N1 had an oculo-respiratory syndrome.     Oculo-respiratory syndrome (ORS) is also a reaction to the influenza vaccine, which includes     symptoms such as bilateral conjunctivitis (red eyes) with swelling of the face or respiratory     symptoms (chest tightness, coughing, a sensation of throat closure, difficulty swallowing,     hoarseness, wheezing or difficulty breathing). The investigators know that ORS is not a true     allergic reaction. Because many signs and symptoms of ORS are similar to those observed     during an allergic reaction, it is often difficult to distinguish ORS from an allergic     reaction.      This study will compare three groups of patients: those who had allergic-like reactions,     those who had ORS and vaccinated individuals who had no such adverse events. Pregnant women     cannot participate in this study. The study has three goals. First, the investigators want to     determine, among those who had allergic-like reactions after influenza vaccination, what     proportion (percentage) of these people are actually allergic to the vaccine or its     components. Second, among those who are not allergic to the vaccine, which other processes     may have caused these symptoms. Finally, the investigators will try to identify whether there     are features that distinguish patients who have a true allergic reaction from those affected     by ORS, and those that had no adverse events.   "
155583|NCT01247402|"     Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial,     in which consecutive patients candidates for percutaneous intervention of angioplasty to     treat symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will     be assigned to one of two study arms:        1. Treatment Arm: Paclitaxel eluting percutaneous transluminal angioplasty (PePTA)        2. Control Arm: standard percutaneous transluminal angioplasty (sPTA).      Purpose:      To evaluate the morphologic and clinical efficacy of Paclitaxel eluting percutaneous     transluminal angioplasty (PePTA) for the reduction of restenosis in SFA and PA stents     compared to standard percutaneous transluminal angioplasty (sPTA).   "
155621|NCT01246908|"     The purpose of this study is to determine if CX157 is effective and safe in patients with     treatment of treatment resistant depression over six weeks of treatment.   "
155585|NCT01247376|"     Abstract      Background:      Local external cooling of the postoperative field is a treatment paradigm aiming for enhanced     recovery after joint surgery. It is supposed to reduce pain and improve mobilization,     enabling same day surgery.      Hypothesis:      Systematic postoperative cooling and compression after knee arthroscopy will reduce pain and     also be reflected by changes in local levels of metabolic and inflammatory variables in the     synovial membrane.      Study design:      Prospective randomised study; Level of evidence 1.      Methods:      Forty-four otherwise healthy patients were included in the study and randomised to systematic     cooling and compression or NO cooling and compression after knee arthroscopy. Microdialysis     of the synovial membrane was performed postoperatively with measurements of PGE2, glucose,     lactate, glycerol, glutamate and blood flow (ethanol exchange ratio). Local temperature was     monitored as well as postoperative pain (VAS and NRS).      Results:      The application of a cooling and compression device after knee arthroscopy resulted in     significantly lower temperature in the operated knee (skin, joint capsule and     intraarticularly).      The cooling and compression diminished energy requirements in synovial tissue and a 3     temperature sensitive influence on inflammation (PGE2) were shown. No effect on postoperative     pain was detected.      Conclusion:      Local cryotherapy and compression after knee arthroscopy significantly lowered local knee     temperature postoperatively. A correlation with synovial PGE 2 and temperature was shown.      Since PGE2 is a pain and inflammatory marker this implicates a positive anti-inflammatory     effect induced by postoperative local cooling and compression. Hypothermia is proposed to     have a protective effect in ischemic tissue. This is probably due to a decreased metabolic     rate and therefore decreased energy requirements as shown by stable levels of lactate despite     lower blood flow indicated by increasing ethanol ratio.   "
155586|NCT01247363|"     Safety study with multiple oral doses of LY2608204 given to patients with type 2 diabetes.     Study subjects will receive once daily doses of LY2608204 for a total treatment duration of     up to 28 days. In this study, each patient will receive increasing doses of LY2608204 until     reaching the highest dose that they can tolerate.      Continuous glucose monitoring devices will be employed for each patient to monitor for     hypoglycemia during study treatment. Dose titration and dose reduction is determined for each     individual patient based on their safety and glycemic data.   "
155587|NCT01247350|"     To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple     doses in Japanese healthy subjects.   "
155588|NCT01247337|"     A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in     combination with systemic gemcitabine and capecitabine in combination with cetuximab in     patient with non-resectable liver metastases from cholangiocarcinoma.   "
155589|NCT01247324|"     This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy     and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with     relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab     600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the     first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks,     with placebo injections matching interferon beta-1a SC three times per week; or interferon     beta-1a 44 mcg SC injections three times per week (with placebo infusions matching     ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96     weeks. Participants who complete the 96-week double-blind treatment will have an option to     enter a single-group, active-treatment, open-label extension period, providing they fulfill     the eligibility criteria.   "
155590|NCT01247311|"     Individuals with kidney disease have a high risk of heart disease. This is not related to     traditional risk factors, such as high blood pressure, high cholesterol or being overweight.     A lack of vitamin D could be the reason why blood vessels become damaged and could explain     the link between heart disease and kidney disease.   "
155591|NCT01247298|"     This investigational study will evaluate if using a combination of TACE along with high dose     SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.   "
155592|NCT01247285|"     This study compared the relative bioavailability (rate and extent of absorption) of 90 mg     Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC     WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy     adult volunteers under non-fasting conditions.   "
155593|NCT01247272|"     This study compared the relative bioavailability (rate and extent of absorption) of 90 mg     Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC     WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy     adult volunteers under fasting conditions.   "
155594|NCT01247259|"     Recently, interest has increased in sublingual immunotherapy (SLIT) for treating allergic     rhinitis. It is often suggested that polysensitized patients might not benefit from specific     immunotherapy as much as monosensitized patients, although further research on this subject     is needed. This study compared the efficacy of SLIT with standardized house dust mite extract     in mono- and polysensitized allergic rhinitis patients.      Patients who were sensitized to house dust mites and treated with SLIT for house dust mites     for at least 1 year between November 2007 and March 2010 were included. The mono-allergen     sensitized group (Mgr) was defined as the patients who were sensitized to Dermatophagoides     pteronyssinus (Dp) or D. farinae (Df; n = 70). The poly-allergen sensitized group (Pgr) was     defined as the patients who were simultaneously sensitized to house dust mites and other     allergens (n = 64). A standardized extract of house dust mites was used for immunotherapy.     Anti-allergic medication and the total nasal symptom score (TNSS), including rhinorrhea,     sneezing, nasal obstruction, and itchy nose, were evaluated before and 1 year after SLIT.      This study enrolled 134 patients. The TNSS improved significantly after SLIT in both groups,     while the change in the TNSS did not differ significantly between the groups. The     anti-allergic medication scores also decreased significantly in both groups, but there was no     significant difference between the groups.      In polysensitized allergic rhinitis patients, SLIT for Dp/Df gave comparable improvements in     both nasal symptoms and rescue medication scores to those in monosensitized patients,     regardless of other positive allergens. SLIT for Dp/Df might be considered in polysensitized     allergic rhinitis patients.   "
155595|NCT01247246|"     This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially     stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in     subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral     cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of     approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and     Week 4 post RT follow-up visits. It also includes a longer follow-up period of approximately     12 months to determine if there is an effect of SCV 07 on the tumor response to ChemoRT.   "
155671|NCT01246258|"     The purpose of this study is to determine whether patients with primary ciliary dyskinesia     (PCD) have reduced or absent otolith function.The otolith system is a specific part of the     inner ear vestibular (balance) system that detects linear movement.   "
155596|NCT01247233|"     The standard treatment for localized breast cancer is based on conservative surgery (when     possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended     total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to     the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the     difficulty for many patients to reach RT centers to receive standard whole breast irradiation     (WBI) after conservative surgery. APBI offers decreased overall treatment time and several     theoretical advantages over WBI, including a decrease in dose delivered to uninvolved     portions of the breast and adjacent organs. If equivalence between the two treatments can be     shown, then APBI will be considered as a historic evolution in breast cancer management.      In this phase III trial, designed in postmenopausal women > 50 years of age, the objective is     to compare the effectiveness and safety of APBI compared with whole breast irradiation. This     study is also designed to ensure high quality criteria for surgery, pathology and RT     techniques in the 3 arms and will allow to provide data on economics and costs.   "
155597|NCT01247220|"     Branch retinal vein occlusion is a leading cause of vision loss. Treatment with ranibizumab     (vascular endothelial growth factor (VEGF) inhibitor) on a monthly basis has been associated     with improved vision results. There is a subgroup of patients with peripheral nonperfusion on     ultrawidefield angiography that appears to be more dependent on anti-VEGF treatment.      In this trial the investigators compare the gold standard of monthly ranibizumab injections     with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography. Each     group will have monthly injections for the first six months, then as needed by either visual     acuity decrease or increased retinal thickness for the subsequent six months.      The primary outcome is visual acuity. Secondary outcomes are reduction in optical coherence     tomography, and number of ranibizumab injections   "
155598|NCT01247207|"     Duchenne/Becker muscular dystrophy (DBMD) is a genetic disorder that develops in boys. It is     caused by a mutation in the gene for dystrophin, a protein that is important for maintaining     normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads     to weakness and loss of walking ability during childhood and teenage years. A specific type     of mutation, called a nonsense (premature stop codon) mutation, is the cause of DBMD in     approximately 10-15% of boys with the disease. Ataluren is an orally delivered,     investigational drug that has the potential to overcome the effects of the nonsense mutation.     This study is an open-label trial for patients with nonsense mutation dystrophinopathy who     received ataluren in a prior PTC-sponsored study at a US clinical trial site. This trial will     be conducted at sites in the US and will evaluate the long-term safety of ataluren, as     determined by adverse events and laboratory abnormalities.   "
155599|NCT01247194|"     The purpose of the study is to assess the safety, tolerability, antiviral effects, and     pharmacokinetics of PPI-461 in patients with chronic hepatitis C virus genotype 1 infection.   "
155600|NCT01247181|"     The investigators hypothesize that sending weekly motivational text messages to people     infected with HIV will encourage them to take their medication, compared to usual care.   "
155601|NCT01247168|"     This study is being conducted to test study drug AZD2461 to see how it may work to treat     solid tumors. The main purpose of this study is to determine the safety and tolerability of     AZD2461. This is the first time the drug has been given to humans and is classed as a first     time in man study. Its main purpose is to establish a safe dosage of the drug and provide     additional information on any potential side effects this drug may cause. The study will also     assess the blood levels and action of AZD2461 in the body over a period of time and will     indicate whether the drug has a therapeutic effect on solid tumors.   "
155602|NCT01247155|"     The purpose of this randomized trial was to examine the value of the review on the first     postoperative day after uneventful phacoemulsification cataract surgery.   "
155603|NCT01247142|"     The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive     pulmonary aspergillosis in exhaled breath condensate.   "
155604|NCT01247129|"     The purpose of this study is to determine whether delaying the superficial inferior     epigastric artery (SIEA) flap results in widening of diameter and enhancing of blood flow of     its donor artery.   "
155605|NCT01247116|"     The purpose of this study is to evaluate the strategy of initiating double oral combination     therapy with bosentan and sildenafil at the time of diagnosis of pulmonary arterial     hypertension (PAH) in a preliminary way.   "
155606|NCT01247103|"     The purpose of the study is to assess the safety, tolerability and pharmacokinetics of     AZD4316 following oral administration of single and multiple doses to healthy volunteers.   "
155607|NCT01247090|"     The death rate of patients with endstage renal disease (ESRD) on dialysis each year is 20%,     with diseases related to the heart and blood vessels causing about half. About 60% of     patients on hemodialysis have high blood pressure, which is poorly controlled in most. Normal     blood pressure in these patients greatly improves the chance of living. Increased fluid in     the body and bloodstream is a major cause of hypertension in patients with ESRD. Fluid     removal during hemodialysis is often limited by symptoms of low blood pressure during the     procedure. Therefore the increase in fluid and related high blood pressure is ongoing for     many of these patients. Arginine vasopressin (AVP) is a hormone naturally produced by the     body which has little effect on blood pressure in healthy people, but acts as a powerful     vasoconstrictor (narrows the blood vessels) when blood pressure is threatened. Recent studies     have shown when there is too little AVP, patients are more likely to have low blood pressure     during dialysis that limits fluid removal, an effect that can be reversed by giving these     patients low doses of AVP. This phase II trial will find out which of two doses of AVP (.15     or .30 mU kg-1 min-1), in combination with standard therapy, works best to change     interdialytic 44-hour ambulatory systolic blood pressure after 2 weeks. Patients who enroll     in this study will be divided into three groups. One group will be given a 0.15 mU kg-1 min-1     dose of AVP at each dialysis session over a 2-week period; the second group will be given AVP     0.3 mU kg-1 min-1 at the same interval; and a third group will be given normal saline     (placebo) at the same interval. All patients will be closely monitored for side-effects.   "
155672|NCT01246245|"     The incidence of pin site infection is related to the nursing management of external     fixation.   "
155797|NCT01244568|"     Researchers in this study will determine whether providing decision support interventions     (DESIs) to men with low risk prostate cancer improves their decision-specific knowledge and     alters their treatment decisions.   "
155611|NCT01247038|"     The aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal     articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal     articulation using the same cup in regards to the composite clinical success (CCS) rate at 2     years postoperatively (delta = 10% minimum clinically significant difference in rates).   "
155612|NCT01247025|"     The primary research question in this study will ask, among those receiving outpatient mental     health services (MHS) at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans     Affairs Medical Center (VAMC), how many suffer from Prolonged Grief Disorder (PGD)? Here, it     is hypothesized that PGD will occur within the sample. A secondary aim of this study will be     to investigate how often PGD co-occurs with posttraumatic stress disorder (PTSD) and/or     depression. Also, while PGD has been shown to have an effect on self-directed violence (SDV)     among civilians (Prigerson, Bridge et al., 1999), no studies yet have examined the     relationship between PGD and SDV among Veterans. Therefore, it also is hypothesized that as     PGD severity increases among the Veteran sample, risk for SDV will increase as well.     Additional research aims also will be addressed in this study. For one, it will be assessed     which grief symptoms are most often reported among the Veteran sample. Also, no study has yet     to examine if there are neuropsychological differences between PGD and PTSD. Therefore,     another research question here is whether PGD indeed is neuropsychologically different from     PTSD. Here, the exploratory hypothesis is that PGD sufferers will respond to a measure of     multiple components of cognition (e.g., planning, sequencing, concentration, multitasking,     and memory efficiency) in a manner that is significantly different from PTSD sufferers.   "
155613|NCT01247012|"     Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver     disease (PNALD). The purpose of this study is to determine the effect of treatment with a     smaller amount lipid minimization) of our standard soybean oil based intravenous lipid     emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with     severe cholestasis.   "
155614|NCT01246999|"     A total of 88 children between 2 and 9 years of age will be randomized to receive a two dose     schedule of either licensed live attenuated trivalent seasonal influenza vaccine (LAIV) or     licensed inactivated seasonal influenza vaccine (TIV)or TIV followed by LAIV or LAIV followed     by TIV separated by 28 days. Children with a laboratory documented history of prior H1N1     infection will be excluded.   "
155615|NCT01246986|"     The purpose of this study is to estimate the median time to progression in participants with     hepatocellular carcinoma (HCC) when treated with LY2157299 as monotherapy and in combination     with sorafenib or ramucirumab.   "
155616|NCT01246973|"     The purpose of the study is to determine whether curcumin, an ingredient of some foods, can     prevent or reduce the severity of skin reactions (dermatitis) caused by radiation therapy.     Dermatitis is a common side effect of radiation treatment, but few effective treatments have     been developed for it. Curcumin is a natural compound found in both turmeric and curry     powder. It has been used for centuries as a spice (curry), a food coloring and as a food     preservative. Curcumin is non-toxic and has been found to enhance the functions of normal     tissues..   "
155617|NCT01246960|"     The purpose of this study is to determine whether ramucirumab when used in conjunction with     chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal     cancer.   "
155618|NCT01246947|"     The mitral valve is the inflow valve into the main pumping chamber of the heart. It can     become leaky or narrow, and cause blood to back up into the blood vessels of the lungs. When     patients get symptoms from a leaky or narrow mitral valve, surgery is recommended to either     fix or replace the valve. Many patients with mitral valve disease also develop a leaky     tricuspid valve - the tricuspid valve is the inflow valve to the right side of the heart (the     right heart pumps blood across the lungs). The amount of leakiness of the tricuspid valve is     determined by an ultrasound test, and the amount of leakiness is graded as: none, mild,     moderate, or severe. When a heart surgeon operates on a patient with a diseased mitral valve,     he or she will fix the tricuspid valve if the tricuspid leakage is severe. This involves     sewing a cloth-covered ring around the valve and narrowing it. If the tricuspid valve leakage     is only mild (or absent), the surgeon will leave the tricuspid valve alone at the time of     mitral valve surgery. If the tricuspid valve has moderate leakage surgeons are uncertain     about what to do. In a recent review of thousands of patients across the nation having mitral     valve surgery with moderately leaky tricuspid valves, 35 % of patients had tricuspid valve     repair. Since the investigators don't know what the best approach is: to leave the moderately     leaky tricuspid valve alone or to fix it with a cloth-covered ring, the investigators propose     a study to determine which approach is best. Patients having mitral valve surgery with a     moderately leaky tricuspid valve will be randomized to either 1. have a tricuspid valve     repair or 2. to not have a tricuspid valve repair. The investigators will carefully follow     these patients for two years and see if heart function is better among those who got their     valve fixed.   "
155619|NCT01246934|"     In this study the investigators are presenting the advantages as well as the disadvantages of     ACUTE SHORTENING AND RELENGTHENINIG VS SEGMENT TRANSPORT methods.   "
155620|NCT01246921|"     Rationale: Vitiligo vulgaris is a common acquired pigment disorder, which is characterised by     the development of depigmented macules. It develops probably due to immunedestruction of     melanocytes. Most effective therapies are immunsuppresive:        1. local immunesuppressives like corticosteroids and calcineurin inhibitors        2. phototherapy like PUVA and NB-UVB phototherapy. NB-UVB is the first choice A synergistic          effect of UVA and topical corticosteroids (fluticasone proprionate 0.05% cream) has been          described by Westerhof et al. in 1999. To our knowledge to date there are no          publications comparing NB-UVB combined with a topical corticosteroid and NB-UVB alone.      Objective: The objective of this study is to evaluate the clinical effects (onset and degree     of repigmentation) of fluticasone proprionate 0.05% cream (thrice weekly) on NB-UVB     phototherapy twice weekly for a period of 12 months.      Study design: Prospective single blinded randomised controlled study. Study population:     Consecutive patients ≥ 18 years, diagnosed with active vitiligo vulgaris who will receive     NB-UVB phototherapeutic treatment at the Netherlands Institute for Pigment Disorders at the     Academic Medical Centre (AMC), University of Amsterdam.      Methods: The patient will be randomised for either NB-UVB phototherapy and fluticasone     proprionate 0.05% cream or NB-UVB phototherapy alone for 12 consecutive months.      Main study parameters/endpoints: The onset and degree of repigmentation is assessed by     digital image analysis of a target lesion and blinded global physician assessment.     Furthermore, the patients and doctors satisfaction will be assessed and changes of     immunohistochemical parameters will be analysed in skin biopsies.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Subjects participating in the study will be asked to visit the institute 4     times. The time investment will be 20 minutes per visit. Additionally, patients will be asked     for consent to take punch biopsies (3 mm) at the beginning and at the end of the treatment     period. Hence, skin biopsies are not compulsory for participation in this study. Patients may     chose to participate in the clinical non invasive part of the study. Known side effects of     the NB-UVB phototherapy are redness, pruritus, xerosis cutis, burning sensation and     conjunctivitis. These side-effects however, are largely dose-dependent and avoidable.     Corticosteroid associated systemic side-effects (suppression of the adrenocortex) will be     minimized by treating only a limited body surface [a maximum of 30% body surface] and by     using an intermittent application scheme of three days a week in the long term treatment. The     regions which are known to have a higher absorption are excluded (periorbital, axillary,     inguinal and genital area). Both topical corticosteroids and NB-UVB are part of the Dutch and     British guidelines for the treatment of vitiligo. There is no presumptive evidence or     indication that the combination of these therapies may result in a higher risk of side     effects.      All together the burden due to the study is low and the risk for systemic or local side     effects is low.   "
155622|NCT01246895|"     This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured     lesion (investigational) and microfracture alone (control) for up to 5 years from treatment     in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post     approval study for these Protocols, in support of a commercial application. The lesions     treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage,     grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral     condyles of the knee, and were classified as either acute or chronic.   "
155623|NCT01246882|"     The purpose of this study is to determine the effects of daily feedback about physical     activity (number of bouts of walking, duration of bouts, total walking distance, average and     fastest walking speed) and walking average speed compared to feedback about walking speed     only on walking-related outcomes during inpatient rehabilitation for stroke. For the first     time, daily walking and other exercise will be monitored by bilateral triaxial accelerometers     on the ankles. Activity-recognition algorithms will analyze the inpatient sensor data and     return a summary to the participants at each site.   "
156051|NCT01241214|"     This study will assess the efficacy and safety of different doses of ACT-129968 in adult     patients with seasonal allergic rhinitis, due to mountain cedar pollen.   "
155624|NCT01246869|"     Purpose of Study This exploratory clinical study will investigate FMISO (fluoromisonidazole)     in patients with (1) newly diagnosed primary malignant brain tumors (WHO [World Health     Organization] Grade III or IV glial-based tumors) who have not had a complete surgical     resection and by contrast MRI (Magnetic resonance imaging) have residual tumor > 1.0 cm in     diameter and will be receiving radiotherapy or (2) newly diagnosed brain metastasis (> 1.0 cm     in diameter who will be receiving radiotherapy. The ability to accurately assess tumor     hypoxia and accurately determine the amount/degree of tumor hypoxia could potentially change     patient management once validated as tumor hypoxia is known to be associated with a poor     prognosis [Eyler 2008].   "
155625|NCT01246856|"     Many patients with breastcancer in the past, were treated with TAC. These last years, there     is more and more focus on the effects of chemotherapy, particularly in children treated with     this. One of these effects is damage to the heart muscle, which ultimately might affect the     pump-function of the heart . In adults, the effect of treatment with TAC on the heart, has     not been previously investigated. The possibility exists that the adverse reactions in     children are found in adults also could occur. Therefore we have initiated this trial.   "
155626|NCT01246843|"     Patients with advanced kidney cancer or GIST (Gastro Intestinal Stromal Tumor: this is a     tumor of the intestines) may be eligible for treatment with one of the following drugs:     sunitinib (Sutent ®) or sorafenib (Nexavar ®). These drugs inhibit blood vessel formation in     cancer cells. These cancer cells are hampered in their growth. To enlarge the investigators     knowledge on the effects and side effects of these two medicines, in the University Medical     Center St. Radboud lot of research is done. This study is a part of that.      Patients receiving sunitinib or sorafenib tell sometimes that they feel that they are less     able to concentrate, that their memory is not working properly or that they are less able to     imagine a solution to a complex problem . Perhaps you recognize these symptoms as well. In     how many of the patients this occurs, how severe the symptoms are and how it is caused, is     still unknown.      The goal of this research is to examine how memory, concentration and knowledge processing     works in patients using sorafenib or sunitinib. With the research the investigators hope to     get answers to the following questions:        1. How common are problems with memory, concentration and processing of knowledge in          patients receiving the drug sunitinib or sorafenib?        2. What are the problems of memory, concentration and processing of knowledge in the use of          sunitinib or sorafenib?        3. What could be the cause of the problems that patients experience from memory,          concentration and processing of knowledge in the use of sunitinib or sorafenib?        4. Is there a link between problems with memory, concentration and processing of knowledge          and also experiences of fatigue or mood of a patient?   "
155627|NCT01246830|"     Research questions:        1. Will the panoramic images derived from cone beam CT data give better diagnostic ability          than conventional panoramic radiographs?        2. Will 3D cephalometric analysis offer the orthodontists and surgeons better information          for treatment planning?        3. Will the 3D cephalometric analysis give more accurate treatment plan and better          treatment outcome?      General hypothesis and special aims      Overall aims:        -  To compare 2D versus 3D cephalometric analysis: treatment planning and therapeutic          outcome.        -  To determine the accuracy and diagnostic ability and usability of the 3D cephalometric          analysis.        -  To evaluate the diagnostic ability and usability of the panoramic image derived from          cone beam CT data as compared to 2D panoramic images.        -  To evaluate the value of the cone beam CT data in cephalometric analysing process for          orthodontic and maxillofacial surgery treatment.      Hypotheses:        1. The availability of the 3D cephalometric analysis influences the orthodontic and          maxillofacial treatment plan and decision, and might change the treatment outcome.        2. Panoramic images derived from cone beam CT data may provide equal information for          diagnosis as conventional panoramic images.        3. Cone beam CT will be able to replace classic orthodontic imaging being more time and          dose efficient and having a beneficial effect on treatment outcome.   "
155628|NCT01246817|"     This study uses one trialdrug: Temsirolimus (sometimes called Torisel ® ). Temsirolimus is an     mTOR inhibitor. It is an agent that is specifically aimed at disrupting cell division (needed     for cancer cell growth). Temsirolimus has been shown to inhibit the growth of cancer cells.     For patients with metastatic kidney cancer Temsirolimus is now a registered , conventional     therapy. It has been recorded for patients as they get renal cell cancer metastases and which     looks as if the tumor is aggressive.      This is a phase II trial. This means that the investigators look at how effectively     temsirolimus is, after treatment with other drugs against kidney cancer. Effective means that     the investigators see how well the treatment is, the investigators look at how long the     disease is not growing and if it does, that is smaller. The possible side effects will be     carefully watched.   "
155629|NCT01246804|"     The objective of this study is to evaluate the effect of ginkgo biloba (steady state) on the     pharmacokinetics of a single dose of the UGT-substrate raltegravir. Furthermore the safety     profile of the combination is studied.   "
155630|NCT01246791|"     The purpose of this study is to assess the pharmacokinetic profiles of norethisterone and     ethinyl estradiol after single oral administration of NPC-01 in healthy female volunteers.      Pharmacokinetics of norethisterone and ethinyl estradiol will be evaluated on the basis of     AUC, Cmax, tmax, t1/2, MRT, kel and AUC∞.   "
155631|NCT01246778|"     Rationale:      Recently, sunitinib (a tyrosine kinase inhibitor that is used for treatment of metastatic     renal carcinoma and gastrointestinal stroma tumors) has been associated with development of     heart failure, possibly by off-target inhibition of AMP-protein kinase. The investigators     hypothesize that sunitinib reduces the contractile ability of myocardium and the tolerance     against ischemia-reperfusion and that activators of AMP-protein kinase such as atorvastatin     and AICAR reverse this unwanted effect of sunitinib.      Objectives:      The primary objective of the study is to investigate the effect of sunitinib on ex-vivo     atrial contractile force in absence and presence of ischemia-reperfusion.      A secondary objective is to explore if atorvastatin or AICAR prevent sunitinib-induced     deterioration of contractile function of human atrial trabeculas. Study design: Lab   "
155632|NCT01246765|"     The purpose of the National Pregnancy Registry for Atypical Antipsychotics is to determine     the frequency of birth defects among infants exposed to atypical antipsychotics.   "
155634|NCT01246739|"     Incidental findings of adrenal tumours,incidentalomas, occur in 1-5 % in the general     population and 10-25 % of these patients will exhibit biochemical mild hypercortisolism.     Although the patients do not have clinical signs of classical Cushing's syndrome, they have     an increased risk for hypertension, dyslipidemia, diabetes mellitus, osteoporosis and     obesity.      The hypothesis of the study is, that surgery of the adrenal adenoma responsible for the     increased secretion of cortisol, will in part cure or ameliorate the metabolic syndrome.   "
155635|NCT01246726|"     This is a pilot study comparing the appearance and volume of the post surgical region in the     intact breast, as determined by 3 modalities: computed Xray tomography (CT), 3 Dimensional     ultrasound (USS), Magnetic resonance imaging (MRI) after breast conserving surgery and during     whole breast irradiation.   "
155636|NCT01246713|"     The purpose of this study is to determine whether excipients in the liquid formulation of     acetaminophen prevent the formation of the toxic metabolites of acetaminophen.   "
155637|NCT01246700|"     The purpose of this study is 1.) to determine if sensory attention focused exercise is an     effective management strategy for Parkinson's disease, and 2.) to identify if the benefits     are a result of strength gains.   "
155638|NCT01246687|"     Introduction: The Internet holds promise for a wide-scale promotion of dietary and lifestyle     behavioural change. Website-delivered interventions have a potentially broad population reach     as it is available 24 hours, and could be hosted by both government and non-governmental     agencies. To date, there is no published study focused on dietary behaviour change in adults     with Type 2 Diabetes Mellitus (T2DM) via a website-based system.      Objective: To improve nutrition knowledge, attitude and behaviour (KAB) of the patients with     T2DM through a 6-month dietary education programme delivered via a website. The secondary     objectives of this study are to improve the participant's selected anthropometric     measurements, dietary practices and biomarkers.      Hypothesis: A 6-month web-based dietary education programme will improve diabetic patients'     nutrition KAB.      Methods: This is a two-armed matched-design randomized controlled trial (RCT) scheduled for     two years in three public hospitals in Klang Valley. It will be carried out with quantitative     techniques to measure the primary and secondary outcomes. Permission from relevant     authorities has been obtained for this purpose. The targeted sample size is 100 subjects,     with 50 subjects in each arm. The intervention group will be required to participate in a     6-month web-based dietary intervention, while the control group will receive the usual care     given to diabetic patients. The subjects will then be followed up for another 6 months. Data     collection will be held at baseline, 6-month and 12-month.      Expected results: The dietary recommendations are personalised according to the Stages of     Change (SOC) the patient is in. The improvements in knowledge and attitude, and progress in     SOC are expected to be reflected in the patients' dietary behaviour. Adoption of healthy     dietary practices then is expected to be reflected on the anthropometric measurements and     biomarkers. In the long run, the findings are expected to assist promotion of healthy diet     and lifestyle to high-risk groups as well as Malaysian public in line with technology     development. Moreover, the output from this research may serve as recommendation to Ministry     of Health and other related NGOs on effective dietary intervention strategies for prevention     of T2DM and complications which arise from the disease in this country.   "
155639|NCT01246674|"     By this study the investigators wish to (1) quantify hip strength and functional-performance     deficits at discharge after fast-track total hip arthroplasty (THA), and (2) investigate if     changes in thigh circumferences, or hip pain are correlated to changes in hip strength and     functional-performance after fast-track THA.   "
155640|NCT01246661|"     The purpose of this study is to evaluate if the UpSpring Milkscreen Alcohol Test works to     detect alcohol in breast milk that will be donated during this study. This research is being     done because the sponsoring company, UpSpring, wants to determine if this test will work and,     if it does, how well it will work to detect levels of alcohol in breast milk.   "
155641|NCT01246648|"     The etiopathogenesis of periodontal disease results from complex interaction between     infectious agents, mainly including bacteria, and host cellular and humoral immune responses.     However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain     all biological and clinical features of the destructive periodontal disease. The main     hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by     altering epithelial gingival cell biology and consequently may promote the initiation and     progression of periodontitis.   "
155642|NCT01246635|"     The purpose of this clinical study is to demonstrate the effectiveness and safety of the     Trufit CB (Cartilage Bone) implant for the treatment of single, isolated cartilage defects of     the knee compared to Microfracture.   "
155643|NCT01246622|"     This phase I trial is studying the side effects and best dose of lenalidomide when given     together with cytarabine in treating patients with relapsed or refractory acute myeloid     leukemia (AML). Biological therapies, such as lenalidomide, may stimulate the immune system     in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving lenalidomide together with cytarabine may     kill more cancer cells   "
155718|NCT01245634|"     This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety     of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing     elective or urgent coronary artery bypass (CABG) surgery. Patients will be randomized to     receive either RO4905417 20 mg/kg by intravenous infusion or placebo every 4 weeks for 32     weeks.   "
155798|NCT01244555|"     The purpose of this study is to determine the effectiveness of treatments (massage therapy or     ultrasound) directed at skeletal muscle for alleviating pain associated wtih tension     headache.   "
170293|NCT00059332|"     The goal of this study is to evaluate the effectiveness and safety of field-initiated     magnesium sulfate in improving the long-term functional outcome of patients with acute     stroke.   "
155656|NCT01246453|"     1. Objectives:             -  Main objective: To evaluate the efficacy and safety of intrapleural alteplase vs               urokinase in patients with complex complicated parapneumonic pleural effusion and               empyema.             -  To evaluate the pleural and plasmatic levels of the fibrinolytic system markers               after the treatment with alteplase vs urokinase             -  To evaluate the safety of alteplase in the treatment of complex complicated               parapneumonic pleural effusion and empyema        2. Design: Multicentric, randomized, parallel, controlled and double blind        3. Main variable: Percentage of curation        4. Study population and number of patients: 204 patients with complex complicated          parapneumonic pleural effusions and empyema        5. Duration of the treatment: Three days (main variable), and optional three days          (secondary variable)   "
155657|NCT01246440|"     The purpose of this study is to evaluate the efficacy and safety of catumaxomab as     consolidation treatment in patients with epithelial ovarian cancer in second or third     complete remission.   "
155658|NCT01246427|"     The purpose of this study is to evaluate the efficacy of a homeopathic treatment (BRN01) in     reducing hot flash scores after 4 weeks of treatment.   "
155644|NCT01246609|"     Background:      There are several surgical procedures in which irrigation fluids are used to enable vision     and treatment in body cavities, such as hysteroscopy, arthroscopy and cystoscopy. Several     solutions are used for irrigation: normal saline, glycin, mannitol, sorbitol and others.     Post-operative complications, as visual disturbances, confusion and other neurologic symptoms     were attributed to irrigation fluid absorption, water intoxication and hyponatremia, and are     refered to as TURP syndrome when appearing following transurethral prostatectomy (TURP).     Historically, a reduced serum sodium concentration has been used to diagnose absorption of     electrolytes-free irrigating fluid during urologic procedures. However, neurologic symptoms     following transurethral prostatectomy (TURP) do not correlate with blood sodium level,     moreover, Hyponatremia may not be the sole or even the primary cause of the neurological     manifestations of TURP syndrome. Other techniques were suggested for evaluating the volume of     irrigation solution absorption though none is used routinely in the clinical setting.      Percutaneous Lithotripsy (PCNL) is a procedure used to treat patients with nephrolithiasis.     In this procedure irrigation fluid is administered into the kidney and urinary tract     collecting system. The solution used is normal saline. In earlier studies there was no     evidence for absorption of the irrigation fluids, though medical literature on this issue is     limited. However, minute changes in electrolytes and acid-base balance may indicate the     opposite is true. Indeed, the volume of irrigation and duration of the procedure may have an     effect as well. According to the investigators hypothesis, the change in Ph and reduction in     base content in patients undergoing PCNL may be the result of irrigation fluid absorption,     since chloride from the normal saline is known to cause such effect.      Methods This is an observational prospective study of consecutive 200 adult patients     undergoing elective surgery of PCNL in the investigators operating rooms.      The investigators will collect data that is taken from the patient's file and routine     management of these patients: age, gender, weight, pre-operative blood tests including:     electrolytes, creatinine, hematocrit, ph, bicarbonate, base, length of the procedure, volume     and type of irrigation fluids used, volume and type of intravenous fluids used.     Post-operative blood tests will be recorded.      The investigators will compare pre and post-operative blood tests, especially ph,     bicarbonate, base content, sodium. The investigators will analyse statistically the     correlation between the change of each parameter (delta X) and the volume of irrigation     fluids used during the surgery.   "
155645|NCT01246596|"     The etiopathogenesis of periodontal disease results from complex interaction between     infectious agents, mainly including bacteria, and host cellular and humoral immune responses.     However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain     all biological and clinical features of the destructive periodontal disease. The main     hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by     altering epithelial gingival cell biology and consequently may promote the initiation and     progression of periodontitis.   "
155646|NCT01246583|"     The study is being conducted to see whether CP-690,550 ointment has potential as a safe and     effective treatment for adult patients with mild to moderate chronic plaque psoriasis.   "
155647|NCT01246570|"     It is known that organized cardiac rehabilitation is effective in improving exercise capacity     in coronary heart disease patients. Less is known about the long-term results after cardiac     rehabilitation. Earlier studies have shown that many patients quit exercising when no longer     attending formal rehabilitation. The investigators wish to investigate the effect of a     maintenance program after ending a rehabilitation program, and to compare this to usual care.     The investigators hypothesis is that the maintenance program will result in higher exercise     capacity and more physical activity compared to usual care.   "
155648|NCT01246557|"     Despite certain notable progress, treatment of patients with Chronic Lymphatic Leukemia (CLL)     is still disappointing. Although thanks to the use of treatment of (immune) chemotherapy,     mainly based on fludarabine, rituximab and alemtuzumab, the rate of complete response (CR)     has increased from minus 10% observed when clorambucil was the core of the therapy to a     60-70%, with time all patients relapse and most of them die at the end due to the disease or     to involvements related to the treatment. Progress when understanding the CLL biology have     cleared a series of aspects: 1) there is a significant proportion of CLL cells actively     copying themselves, contrary to the opinion that most of CLL cells are in G0 phase of the     cell cycle; 2) Immune regulatory mechanism basically measured by T cells and NK cells have an     important role in the continuous accumulation of CLL cells in the body; 3) Cells of the     stroma are essential to maintain survival of CLL cells through a series of cytokines or     chemokines. Under the light of this evidence, it is worth studying new treatment modes     directed not only to CLL cells but also to the microenvironment and immune functions.      Lenalidomide is being investigated as treatment for several oncologic indications including     myelodysplastic syndromes, multiple myeloma and non-Hodgkin lymphoma. Within the scope of     CLL, it has been proved that lenalidomide is active in patients with relapsing / treatment     resistant CLL patients. Forty five patients with relapsing CLL, 51% resistant to fludarabine,     where included in a phase II study and were treated orally with 25 mg of lenalidomide on days     1 to 21 of a cycle of 28 days. The total response rate was of 47% with up to a 9% of complete     responses.      The combination of lenalidomide with dexamethasone is being investigated in multiple myeloma     and has revealed as a highly efficient treatment in relapsing/ treatment resistant patients     as well as in those newly diagnosed. Bearing in mind that both drugs, lenalidomide and     dexamethasone, are clinically active in CLL the investigators have designed a study with this     combination in relapsing or treatment resistant patients following treatments containing     fludarabine which do not meet the requirements for an intensive rescue treatment.      Given initial doses of 10 and 25 mg of lenalidomide daily may be associated with tumor lysis     cases, it is proposed a low initial dose of lenalidomide in the first cycle 2.5mg., with     further increases to prevent the occurrence of tumor lysis syndrome   "
155649|NCT01246544|"     In cooperation with INABBRA (Innovation Alliance Berlin-Brandenburg, Germany) the     investigators would like to ask medical colleagues in the region to participate in an     anonymous German online survey on patient safety.      The investigators want to investigate the implementation and establishment of measures on     patient safety, that anaesthesiologists utilize to fulfill their obligations.   "
155650|NCT01246531|"     Urinary lithiasis is a common disease on young adults, but not so far on aging people.     Nowadays, the investigators are seeing a gradative growth on men above sixty years old,     mainly in industrialized countries. The purpose of this study is to investigate metabolic     aspects of aging men with renal stones, towards blood tests, 24 hour-urinary samples,     imagenological exams and bone densitometry. The investigators have made a case-control model.   "
155651|NCT01246518|"     Onychomycosis is a fungal infection that affects fingernails and/or toenails.      The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of     patients with fungal infection of the toenails.   "
155652|NCT01246505|"     Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the     lower extremities.   "
155653|NCT01246492|"     The purpose of this study is to determine whether the presece of the artificial sweeteners     aspartame, saccharin and asceulfame-k affect the blood glucose responses to an orally     incested glucose solution.   "
155654|NCT01246479|"     The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a     pediatric population vaccinated in the parent study IC51-322.   "
155655|NCT01246466|"     The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac     surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in     treating AF, and how effective this combined procedure is using the AtriCure System in     treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac     surgery and a standard electrophysiology catheter, currently available, will be used to     perform the catheter ablation procedure. This surgical procedure is considered less invasive     because it is done through tiny surgical punctures on the sides of the chest near the ribs     instead of one large surgical incision of the breast bone to completely open the chest and     access the heart, and it also avoids the need for the heart-lung bypass machine.   "
155660|NCT01246401|"     Specific Aim: To conduct a randomized, placebo-controlled trial of extended     release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners     meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for opioid dependence who are     transitioning from the structure of a correctional setting to the community.      Hypotheses:      i. XR-NTX will result in improved HIV clinical outcomes, including lower changes in HIV-1 RNA     levels, higher CD4 counts and higher rates of retention in care.      ii. XR-NTX will result in improved opioid treatment outcomes, including longer time to opioid     relapse, lower addiction severity and lower craving for opioid.      iii. XR-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the     control group.      iv. XR-NTX will result in decreased rates of reincarceration after 12 months of release to     the community.   "
155661|NCT01246388|"     The purpose of this study is to evaluate non-invasive parameters for staging and grading of     chronic hepatopathy in comparison to liver biopsy.   "
155662|NCT01246375|"     The purpose of this research is to determine whether the prevalence of osteoporosis is     greater in patients who suffer from Chronic obstructive pulmonary disease (COPD) or Asthma     disease and uses inhaled steroids.   "
155663|NCT01246362|"     The purpose of this study is to study the efficacy of pre-emptive etoricoxib in reducing     post-operative pain and improving function outcome after a total knee arthroplasty.   "
155664|NCT01246349|"     The investigators studied the effect of motivational interviewing (MI) on self-efficacy,     health behaviors, and health outcomes in overweight children and adolescents (ages ranging     from 10 to 18 years).   "
155665|NCT01246336|"     Parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis     and differential diagnosis are not yet available. Exhaled breath testing may yield a     breath-print that can be used to distinguish healthy and diseased states.   "
155666|NCT01246323|"     The purpose of this study is to determine whether combined anesthesia will provide better     pain control for the postoperative period following gynecological laparoscopy surgery.   "
155667|NCT01246310|"     Polycystic ovary syndrome (PCOS) is one of the most common reproductive disorders affecting     5-10% of women of reproductive age. Beside impairments on reproductive functions     (oligomenorrhea/amenorrhea), it also affects metabolism (insulin resistance, type 2 diabetes     mellitus and cardiovascular risk) and psychology (increased anxiety, depression and eating     disorders). Recently, several studies have shown that there is an increased risk of mood     disorders in women with PCOS, with major depression and bipolar disorder as the most frequent     diagnosis.      Myo-inositol is classified as a member of the vitamin B complex and it works as a second     messenger system of several neurotransmitter receptors; furthermore, inositol, when     administrated at pharmacological doses, crosses the blood-brain barrier.      Studies from the 90s showed that inositol, alone or in combination with other antidepressant     drugs (mainly serotonin reuptake inhibitors), is able to induce improvement of the Hamilton     depression rating Scale.      Recently, inositol has been proposed as treatment to improve clinical, metabolic and     endocrinal status in PCOS patients. Administration of myo-inositol to PCOs patients resulted     in several beneficial effects, such as decrease of circulating insulin and serum total     testosterone as well as a restored ovulation.      In this proposed study, the investigators aim to evaluate in a double blind randomized trial     whether inositol alone has beneficial effects on mental health disorders associated with     PCOs. In particular, 60 women in reproductive age that will be diagnosed of PCOs, according     to Rotterdam 2003 criteria, will be recruited and randomly assigned to the inositol or     placebo group. Both groups will go through ultrasonic evaluation of the ovaries and serum     hormonal levels (FSH, LH, testosterone, estradiol and insulin) will be evaluated.     Furthermore, with the help of psychiatrics, patients will be interviewed in order to test the     presence of any mental health disorders using validated tests such as: Hamilton Anxiety Scale     (HAM-A), Hamilton Rating Scale for Depression (HAM-D), Health Assessment Questionnaire (HAQ),     Short Form of Mc Gill Pain Questionnaire (SF-MPQ).      Women assigned to the inositol group will receive 12g of inositol during the day in three     different administrations for a period of 4weeks.      At the end of treatment period patients will be interviewed by psychiatrics and will go     through ultrasonic evaluation of the ovaries and hormonal levels will be tested   "
155668|NCT01246297|"     Patients who have surgery to cure lung cancer often have multiple problems at hospital     discharge and later on. This includes poor exercise performance and quality of life,     breathlessness, pain and tiredness. Currently there is little formal physical or     psychological support for such patients. This pilot study aims to investigate whether     outpatient pulmonary rehabilitation (an exercise training and education programme), started     within 2 weeks of hospital discharge, can lead to improvements in exercise performance and     quality of life in patients who have undergone lung cancer surgery. The study will also     assess whether pulmonary rehabilitation is acceptable for patients and will analyze the     safety profile. The hypothesis is that patients; discharged from hospital after undergoing     lung cancer surgery, have improved exercise performance and quality of life following early     outpatient pulmonary rehabilitation compared with usual care.   "
155669|NCT01246284|"     Alopecia areata (AA) is a disease characterized by areas of hair loss. Localized steroid     injections is the standard treatment for limited disease. There are no existing studies that     compare different concentrations of steroids in the treatment of AA. This study will compare     the efficacy and safety of different concentrations of localized steroid injections in the     treatment of AA. Six treatment sessions will be done over 6 to 9 months. The investigators     will compare the following concentrations: 2,5mg/ml, 5mg/ml, 10mg/ml, and normal saline.   "
155670|NCT01246271|"     There is a concern about choosing adequate surgical options for stress urinary incontinence     associated with vaginal prolapsed and still lack of evidence can be observed. In this study     we compared primary and secondary outcomes of single or combine surgery for SUI with pelvic     organ prolapsed.   "
155673|NCT01246232|"     Schizophrenia is a mental health problem usually starting in the late teens/early twenties,     and often lasting many years. The standard medication ('antipsychotics') for this problem is     usually helpful, and if taken continually can keep people well, reducing the likelihood of     further episodes. However, in up to one in three people with schizophrenia, the illness does     not show much improvement with antipsychotic medication. For some of these 'resistant'     illnesses, one particular antipsychotic, clozapine, can work well, but one disadvantage is     the risk of a severe blood side effect which means that regular blood testing is necessary.     If the response to clozapine treatment is disappointing, there is some evidence that adding     another antipsychotic can sometimes produce more improvement. However, it seems that the     added antipsychotic may need to be taken by the person for at least 10 weeks in order to work     well. The investigators plan to test carefully the possible benefits and problems when the     antipsychotic amisulpride or a dummy tablet ('placebo') is added to clozapine for 12 weeks in     people whose schizophrenia illness has not been helped much by any antipsychotic medication     on its own, and who are now taking clozapine, but again with not much improvement. The     investigators have chosen amisulpride because its pharmacological action may be complementary     to that of clozapine, and also it is less likely than some other antipsychotics to compound     some of the characteristic side effects of clozapine, such as sedation, weight gain and other     metabolic problems.      Adjunctive amisulpride or placebo will be randomly assigned. The investigators expect that     adding amisulpride will be more likely to cause an improvement than adding placebo. But the     investigators should learn more about the risks and side effects of combining these two     medications. Also, the investigators should gain a greater understanding of the possible     benefits of adding another antipsychotic to clozapine in relation to particular problem     symptoms, and a person's ability to live and work in the community.   "
162508|NCT00002354|"     The purpose of this study is to see if it is safe and effective to give indinavir sulfate     plus stavudine to HIV-infected patients who have already been treated with zidovudine.   "
155674|NCT01246219|"     The research aims to provide data on gender-related psychological impact of GH (Growth     Hormone)treatment. Implicit measurable psychological metrics of the therapy outcome on males     are to be evaluated in a Prospective Randomized Controlled Trial. As a secondary axis of the     study, the investigators aim to provide descriptive documentation of the unique distress     signal manifestation implicitly shown by ISS (idiopathic short stature)boys and suggest     methods of early detection and measurement of such manifestations that can be used to cement     guidelines for the treatment in GH.   "
155675|NCT01246206|"     The primary goal of the study is to determine the incidence and severity of acute Graft     versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor     Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the     combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will     determine the safety of this combination in the first six months post transplant.      Secondary goals include determining the time to recovery of white blood cells and platelets     (engraftment), determining the occurrence of opportunistic infections, defined as infection     that occurs in people with weakened immune systems and caused by organisms that do not     normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral     infections), estimating the incidence of chronic GVHD at two years and the overall and     disease free survival at two years.      Immune response will be assessed by means of immuno-correlative studies both prior to and at     various points after transplant.   "
155676|NCT01246193|"     The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed     Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.   "
155677|NCT01246180|"     Pressure ulcers are a common and costly problem. Advancing the understanding regarding the     basic pathophysiological mechanisms mediating the development of pressure ulcers will allow     for better delineation of populations at risk.      Healthy skin is protected from pressure-induced ischemic damage because of the presence of     pressure-induced vasodilation (PIV). In contrast, in absence of PIV, such as in diabetic     patients or older subjects with sensory neuropathy, the skin is exposed to severe cutaneous     ischemia, which could lead to pressure ulcer formation.      Since Acid Sensing Ion channels (ASICs) appear to be involved in the cutaneous     mechanosensitivity, the investigators hypothesized that PIV could be altered by treatments     that block ASICs.   "
155678|NCT01246167|"     This trial is designed to compare head-to-head conservative with operative treatment in 2     stratum. Stratum 1: In 2 part fractures the comparison is between conservative treatment and     operative treatment with plate fixation with Philos. Stratum 2: In multi-fragmented fractures     (MFF) meaning 3 and 4 part fractures, the comparison is between conservative treatment,     operative treatment with Philos plate and operative treatment with Epoca prosthesis. Subgroup     analysis will be performed in an effort to obtain limit values for specific treatment of     different age and fracture groups. A cost-effectiveness analysis and comparison between     different treatment modalities will be carried out. The primary outcome measure will be the     DASH score and the secondary outcome measure the EQ-5D value. Recruitment period is 3 years     and follow-up 2 years.   "
155679|NCT01246154|"     To evaluate exercise tolerance.   "
155680|NCT01246141|"     Functional tricuspid regurgitation is common in patients with heart valve disease,     replacement and repair both can correct this anomaly. However, there is no data to address     which one can bring more benefits to these patients with combined heart valve disease. The     investigators retrospectively review patients with two or more heart valve disease and     functional tricuspid regurgitation, and assess its long term outcomes.   "
155681|NCT01246128|"     Background:      - Previous studies have suggested that smoking cigarettes affects the number of receptors in     the brain for nicotine, a chemical present in cigarette smoke. The receptors play a role in     an individual's ability to think and concentrate. Many people with schizophrenia and similar     disorders smoke, and research suggests that smoking may temporarily improve concentration and     focus in individuals with schizophrenia. Researchers are interested in studying both current     smokers and nonsmokers with schizophrenia to determine whether smoking affects the number of     nicotine receptors in the brains of people with schizophrenia.      Objectives:      - To study the distribution and volume of nicotine receptors in the brains of individuals     with schizophrenia who are either nonsmokers or current smokers.      Eligibility:        -  Individuals between 18 and 50 years of age who have been diagnosed with schizophrenia          and are either nonsmokers or current smokers (at least 10 cigarettes per day for the          past year).        -  Current smokers must be able to give up smoking for 48 hours.      Design:        -  This study involves an initial screening visit and up to five study visits.        -  After the screening visit, participants will have two sessions in which they will          complete questionnaires about thoughts, memory, and smoking habits. Smokers will also          have nicotine blood and carbon monoxide breath levels taken during these sessions,          before and after smoking a cigarette.        -  Participants will have sessions with imaging studies (e.g., magnetic resonance imaging)          to provide baseline measurements for later tests, and will also have tests to measure          brain electrical activity.        -  Participants will have a positron emission tomography (PET) scanning session to examine          the nicotine receptors in the brain. Participants will need to stay overnight          (nonsmokers) or for 2 nights (smokers) as an inpatient before the session. The PET scan          session will take up to 6 hours, although participants will only be in the scanner for          up to 3 hours.        -  Participants will have a follow-up phone call with study researchers 1 week after the          PET scanning session.   "
155719|NCT01245621|"     ENABLE III is a randomized clinical trial that evaluates a phone-based palliative care     intervention designed to improve quality of life, mood, and symptom management for patients     with an advanced stage cancer and their caregivers.      The primary aims of this clinical trial are to determine whether a palliative care     intervention (introduced immediately or 12 weeks after diagnosis) can improve survival,     quality of life, mood, symptom intensity and end-of-life care.   "
178940|NCT00183612|"     This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in     children and adolescents with bipolar disorder or psychosis.   "
155694|NCT01245946|"     -  Acne vulgaris is a common inflammatory skin disease that affects more than 85% of teens          and some people may continue throughout adulthood.        -  Topical retinoids related to oral antibiotics are considered first-line treatment of          moderate inflammatory acne.        -  Recently, photodynamic therapy (PDT) with a photosensitizer, 5-aminolevulinic acid (ALA)          or methyl aminolevulinate (MAL), has proven useful in the management of inflammatory          acne. Although progress has been made in the study of photodynamic therapy for acne, to          date, no study has compared PDT with standard and well-validated pharmaceutical          treatments and with the current recommended therapy for most types of acne combination          therapy with a topical retinoid plus one or more antimicrobial agents.      Hypothesis        -  PDT with the photosensitizer ALA will be effective and safe for the treatment of          moderate facial inflammatory acne.        -  The ALA-PDT is more effective than conventional therapy with oral antibiotics and          topical retinoids in the treatment of moderate inflammatory acne with faster action at          12 weeks of follow-up.   "
155682|NCT01246102|"     Background:      - The experimental drug AT13387 has been shown to have some anticancer effects against tumor     cells by blocking a protein that affects other proteins inside certain cancer cells, and     helps to prevent the cancer cells from reproducing and spreading. AT13387 has not been tested     in humans, and researchers are interested in investigating whether it can be used to treat     solid tumors that have not responded to standard treatments.      Objectives:      - To investigate the safety and effectiveness of AT13387 in individuals with solid tumors.      Eligibility:      - Individuals at least 18 years of age who have solid tumors that have not responded to     standard treatments.      Design:        -  Participants will be screened with a physical examination and medical history, as well          as blood tests and tumor imaging studies.        -  AT13387 will be given in 28-day cycles of treatment. Participants will receive AT13387          twice a week (2 days in a row) for the first 3 weeks of the cycle, followed by a fourth          week without the drug.        -  Participants will have regular blood and urine samples, imaging studies, eye          examinations, and tumor biopsies to monitor the effects of the treatment.        -  Participants will continue treatment with AT13387 unless serious side effects develop or          the tumor stops responding to treatment....   "
155683|NCT01246089|"     The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal     injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).   "
155684|NCT01246076|"     The purpose of this study is to determine the proportion of confirmed responses (complete     response, partial response, and hematologic improvement as defined by revised IWG criteria     during the 12 months of treatment.   "
155685|NCT01246063|"     The aim of this phase I/II trial is to determine the maximal tolerated dose (MTD) of     carfilzomib together with pegylated liposomal doxorubicin hydrochloride (PLD) with or without     dexamethasone, and then to establish the efficacy and safety of this novel combination in     patients with relapsed or refractory multiple myeloma   "
155686|NCT01246050|"     The aim of this study is to serve as a pilot showing the feasibility of a Hub and Satellite     Heart Failure (HF) Provider's Network which will aim to provide improved, evidence-based care     to veterans with HF. Primary Care Providers in the VA Community Based Outpatient Clinics will     undergo a brief period of intensive training in HF management and then practice in a network     of primary care providers supported by the Regional HF Center.   "
155687|NCT01246037|"     The main question of this study is: 'Is selective beta-blocker treatment safe and effective     in reducing sympathetic overdrive, thereby improving RV function and remodeling in patients     with iPAH?'.      In addition to the determination of RVEF, the investigators will explore how beta-blocker     therapy affects sympathetic overdrive, remodeling of the RV, single beat elastance, exercise     capacity and mechanical efficiency.      30 iPAH patients will be randomized to either Bisoprolol- or placebo-treatment in a     double-blinded fashion. A cross-over trial design will be used to increase the power of the     study and to assess long-term effects of Bisoprolol-treatment and -withdrawal. The medication     will be given in an escalating dose regimen (as described in the 'farmacotherapeutisch     kompas', www.fk.cvz.nl) and treatment will be monitored along the guidelines of the American     Heart Association.   "
155688|NCT01246024|"     To investigate the influence of induced hypoxia on the ERG.   "
155689|NCT01246011|"     Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just     undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive     antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be     randomized to receive argatroban and warfarin. 30 subjects with a positive antibody result     and no signs or symptoms of HIT will be randomized to receive no treatment. 30 subjects with     a negative antibody result will also be followed in the study. All subjects will have a     cardiac CT scan at about 30 days post surgery to measure the patency of their coronary artery     bypass vein grafts. This study will evaluate if treating patients who have heparin PF4     antibodies post-CABG with argatroban and warfarin has any effect on the short-term patency of     coronary artery bypass vein grafts.   "
155690|NCT01245998|"     The aim of the study is to establish whether treatment of ST with low-molecular-weight     heparin in preventive or therapeutic doses prevents disease progression and thromboembolic     events (deep vein thrombosis and pulmonary embolism), whether efficacy of     low-molecular-weight heparin differs with regard to the dosage used (prevention, treatment),     and to recognize groups of patients in which treatment with heparin is most efficient, as     well as to determine factors that influence the efficacy of ST treatment with heparin.   "
155691|NCT01245985|"     TPF-C-HIT investigates the combination of induction chemotherapy with TPF followed by     radioimmunotherapy with cetuximab and IMRT plus carbon ion boost with regard to efficacy and     toxicity of the combination regimen.   "
155692|NCT01245972|"     This is a research study to find out more about the use of the pulsed dye laser in the     treatment of basal cell carcinoma and early stage squamous cell carcinoma that has not     invaded deep into the skin. The purpose of this study is to determine whether the use of the     pulsed dye laser (PDL) can completely clear or regress basal cell carcinoma or early stage     squamous cell carcinoma.      Pulsed dye laser is a type of laser that is commonly used to treat lesions on the skin that     have a prominent blood vessel component. It has been used to treat broken blood vessels on     the face, hemangiomas in children and adults, leg veins, port wine stains, and other lesions     with a prominent vascular component.   "
155693|NCT01245959|"     The purpose of this study is to compare induction chemotherapy     (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy with concurrent     chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in     order to confirm the value of induction chemotherapy in NPC patients.   "
155720|NCT01245608|"     The primary purpose of this study is to determine the effects of a fixed dose combination of     valsartan, hydrochlorothiazide, atorvastatin and aspirin (PolyPill) on prevention of     cardiovascular events in adults older than 50.      Various liver-related variables will also be recorded which will allow studying the effects     of PolyPill on the liver and the effect of liver diseases such as nonalcoholic     steatohepatitis on cardiovascular events and the protective effect of PolyPill.   "
155802|NCT01244503|"     The purpose of the study is to demonstrate that the ¹³C-Octanoate Breath Test (OBT) can be     used as an aid, in conjunction with other clinical information and medical history, for     evaluating disease severity and detecting NASH with a high probability.   "
155695|NCT01245933|"     The purpose of this study is to determine the prevalence and severity of extrapulmonary     disorders and to quantify the impact of extrapulmonary organ manifestations on morbidity and     mortality of COPD patients.      Furthermore the investigators evaluate the relationship between systemic inflammation and     organ involvement.   "
155696|NCT01245920|"     This randomized clinical trial will involve at least 25 patients who have selected to receive     a dental implant to replace a missing tooth. One group will receive the test treatment of a     bone graft and a dissolvable membrane at the outer surface of the dental, while the control     group will not receive the bone graft and membrane adjacent to the implant.      The following will be measured: bone thickness and height adjacent to implant, inflammation     of gum tissue, recession of gum tissue, bleeding, pocket depth, and implant success. Patients     will be followed for 1 year, including evaluation time points at 2 weeks, 1 month, 3 and 6     months, and 1 year. Statistical analysis of the data will be conducted.      The hypothesis is that there is no difference with regard to bone thickness, bone height,     pocket depth, bleeding, and implant success rate for grafted implant sites compared to     non-grafted implant sites.   "
155697|NCT01245907|"     The aim is to evaluate effects of internet-based applied relaxation (a simplified version of     cognitive behavioral therapy) for women with menopausal symptoms mainly vasomotoric symptom     (VMS), i.e. hot flashes and sweating. Sixty postmenopausal women with VMS will be recruited     and 30 randomized to applied relaxation (AR) via internet and 30 to a control group which is     a non-treated waitlist group.      At baseline, after 10 weeks of therapy and six, 12 and 24 months after end of therapy women     will be asked to fill in diaries about hot flashes and answer questionnaires on Quality of     Life (Women's Health Questionnaire; WHQ, anxiety and depression measured with Hospital     Anxiety and Depression Scale; HADS and one measuring sleep, Insomnia Severity Index; ISI as     well as one about knowledge of the climacteric and hormone therapy).      The waiting list group will be offered internet based AR after 10 weeks with the same     follow-up as the treatment group.   "
155698|NCT01245894|"     The aim of this study was to measure the effect of low- and high-dose lipid-lowering     treatment with rosuvastatin on the coronary physiology parameters.   "
155699|NCT01245881|"     In several observational studies, non-ablative fractional photothermolysis (FP) has been     reported to bridge the gap between efficacy and tolerability in the treatment of melasma.     While some beneficial effects have been attributed to non-ablative FP in treating melasma,     methodological constraints (e.g., a limited number of patients; no control group assignment)     impair efficacy assessment; currently published results neither allow researchers and     clinicians to draw valid conclusions nor warrant recommendations for therapy. In particular,     bias resulting from poorly designed trials may mislead clinicians into making a wrong     decision and generate not only unnecessary treatment (i.e., costs), but also a risk of side     effects for patients. Therefore, the purpose of this trial was to clarify the efficacy and     safety of FP in the treatment of melasma as compared to the lone application of a     sun-blocking lotion (SPF >50).   "
155700|NCT01245868|"     The purpose of the study is to investigate if a small amount of lignocaine added to     bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can     shorten the duration of the sensoric and the motoric blockade.   "
155701|NCT01245855|"     we hypothesized that periprocedural treatment with intravenous lipo-PGE1 may reduce     myocardial injury and improve clinical outcomes in patients undergoing PCI.   "
155702|NCT01245842|"     The purpose of this study is to evaluate the effect of a hand exercise intervention on     function and osteoarthritis symptoms in persons with hand osteoarthritis .   "
155703|NCT01245829|"     Sepsis contributes to nearly 20% of all hospital deaths and is the leading cause of death on     non-coronary intensive care units. Contamination of the patient environment is common with     organisms such as MRSA, VRE and C.difficile remaining viable for days or weeks on a variety     materials and surfaces. Up to 90% of patient notes and charts on critical care may be     contaminated with potential pathogens including MRSA and it has been shown that healthcare     workers may contaminate hospital paperwork with organisms originating from patients. Cellomed     is a triclosan based laminate which has been shown to possess antimicrobial activity against     MRSA, E.Coli, Enterococcus, Stenotrophomonas and Klebsiella. The study presented for     consideration aims to compare levels of contamination between critical care observation     charts coated with either a 'standard' matt or antimicrobial Cellomed laminate. It is     proposed that paperwork laminated with Cellomed may exhibit reduced levels of contamination     and decrease the potential for cross infection on critical care and potentially other areas     of the hospital in which clinical paperwork is handled.   "
155704|NCT01245816|"     The purpose of this phase III study is to evaluate the safety and efficacy of the combination     of eflornithine and sulindac compared to single agent sulindac or eflornithine in reducing     the number of polyps in patients with familial adenomatous polyposis (FAP).   "
155705|NCT01245803|"     Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI   "
155706|NCT01245790|"     A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects     with impaired kidney (renal) function compared with healthy volunteers with normal renal     function. Stage 1 will include healthy subjects and subjects with end stage renal disease,     while Stage, 2 may include subjects with mild, moderate and/or severe renal impairment     dependent on the outcome of Stage 1. The study will also evaluate safety and tolerability in     subjects with renal impairment.   "
155707|NCT01245777|"     In pregnancy Restless Legs Syndrome(RLS) is more common than in the general population.     During pregnancy iron tablets are the only available safe medication but their efficacy is     rather poor. It is the aim of this study to examine the efficacy, practicability and safety     of the drug Ferinject® containing the active agent Ferric carboxymaltose for the therapy of     Restless Legs Syndrome(RLS) during pregnancy in the case of iron deficiency or anaemia.      20 women with RLS and iron deficiency and/ or anaemia in the third trimester of pregnancy     will receive intravenous Ferric carboxymaltose in one or two single doses. Repeated blood     tests, pre-and post-therapy actigraphy as well as repeated answering of questionnaires     concerning Restless Legs Syndrome(RLS)-symptoms and sleep quality will show the effect of     iv-Iron supplementation on Restless Legs Syndrome(RLS)-symptoms during pregnancy.        -  Trial with medicinal product   "
164867|NCT00005443|"     To improve understanding of three important and intertwined social determinants of health:     social class, race/ethnicity, and gender.   "
155708|NCT01245764|"     The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose     regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in     Sub-Saharan Africa. Data from the current study are needed in order to complement existing     extensive safety data from the GARDASIL™ clinical trials program, and confirm that GARDASIL™     may be administered safely and will induce immune responses in populations from and living in     Sub-Saharan Africa, as GARDASIL™ has not previously been studied in this region of the world.   "
155709|NCT01245751|"     This study was conducted to obtain safety and immunogenicity data after a booster dose of     Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was     compared to similar information obtained after Zoster Vaccine, Live administration to     age-matched and younger participants who received their first dose of Zoster Vaccine, Live.     The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in     participants ≥70 years of age induces an antibody response that is noninferior to that of a     first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose     of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus     (VZV) antibodies.   "
155710|NCT01245738|"     The current study is proposed to investigate the pattern of dyslipidemia and of lipid     treatment practices in patients in India experiencing their first acute cardiovascular event     and the extent of residual dyslipidemia after 12 weeks of treatment with statins.     Dyslipidemia definitions are per the National Cholesterol Education Program - Adult Treatment     Panel III (NCEP-ATP III).   "
155711|NCT01245725|"     The purpose of this study is to determine whether the efficacy of tirofiban (a 25mcg/kg i.v.     bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention     (PCI) plus two hours after the procedure) is more effective than placebo in the setting of     standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or     bivalirudin) among patients undergoing PCI, as assessed by the incidence of adverse cardiac     ischemic events defined as death, myocardial infarction (MI), and urgent target vessel     revascularization (uTVR) within 48 hours following study drug initiation.      A secondary objective of this study is to assess whether tirofiban (a 25mcg/kg i.v. bolus     followed by a 0.15mcg/kg/min i.v. infusion during a PCI plus two hours after the procedure)     is safe compared to placebo in the setting of standard therapies (e.g. aspirin, a     thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as     assessed by the incidence of non-CABG-related TIMI major bleeding within 48 hours following     study drug initiation.      Patient enrollment is pending.   "
155712|NCT01245712|"     The goal of this clinical research study is to find out if receiving a 1-week course of     partial breast irradiation (PBI) using proton therapy will cause fewer and/or less severe     side effects (such as changes to the appearance of the breast) than a longer course of     radiation treatment.   "
155713|NCT01245699|"     The investigators will quantify the quality of chest compressions provided in the Emergency     Department and determine whether the quality of chest compressions is related to patient     outcome. The quality of chest compressions and patient outcomes will be assessed both before     and after the introduction of audiovisual feedback in real time.   "
155714|NCT01245686|"     Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of     death in the US. Every year, more than one million Americans have a heart attack, and nearly     800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than     $316 billion in health care and lost productivity.      Both lifestyle changes and medication can reduce the risk of CVD, and this project combines     these approaches in the hopes of identifying a practical intervention for use in primary care     medical offices. The project combines two previously tested interventions and updates them to     meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs     (statins).      The research team is delivering the combined intervention in two formats: web-based and     counselor-based. Each format has the same content, but the web-based advice is accessed     through the Internet by clients at home, a community site, or a primary care office. The     other format involves sessions delivered to clients by a counselor either in person at a     primary care office or over the telephone. The researchers will compare how effective each     format is in reducing participants' risk of coronary heart disease. They will also determine     the interventions' effect on participants' diet, physical activity, smoking status,     medication adherence, and other health indicators. In addition, the team will compare the two     formats' cost-effectiveness and how well the patients, office staff, and clinicians accept     the interventions.      Recruited from five family practices, 600 patients representing the geographic and ethnic     diversity of North Carolina are taking part in this study. Half the participants are randomly     assigned to the web-based intervention; the other half to the counselor-based version. Both     groups will also get information on local resources, such as gyms and farmers markets, that     can help participants maintain a healthy lifestyle.   "
155715|NCT01245673|"     One purpose of this study is to find out if a new combination of immune system treatments     (MAGE-A3 vaccine plus activated T-cells) will allow the body to build up protection     (immunity) against the myeloma cells. A second purpose is to find out how well this     combination of immune system treatments is able to control the myeloma.   "
155716|NCT01245660|"     Modification of the EGF signalling pathway and / or HER 2, by Lapatinib in bladder cancer.   "
155717|NCT01245647|"     The purpose of the study is to find out if a medication,naltrexone is helpful for     HIV-infected women who sometimes drink too much. The study will try to find out whether women     like the medication, whether the medication helps them cut back on their drinking, and     whether it helps improve their overall health. Naltrexone has not been used widely among     people who are engaged in less severe drinking and in primary health care settings.     Therefore, the investigators would like to determine whether it is helpful among women who     sometimes drink 4 or more drinks per occasion or 7 or more drinks per week. The investigators     hypothesize that by taking naltrexone, women with hazardous drinking pattern will reduce     their drinking which in turn will improve their medication adherence, improve their health     and quality of life.   "
155722|NCT01245582|"     Primary Objective:      - To evaluate the efficacy of SECOX regimen by adding oxaliplatin plus capecitabine to     sorafenib versus sorafenib alone as palliative treatment for unresectable HCC patients to     prolong overall survival (OS) for advanced HCC patients.      Secondary Objective:        -  To compare the efficacy of SECOX regimen with Sorafenib alone for progression free          survival (PFS)        -  To compare the efficacy of SECOX regimen with Sorafenib alone for response rate (RR)        -  To assess the overall safety profile of SECOX regimen in comparison of Sorafenib alone   "
155723|NCT01245569|"     The purpose of the present study is to determine the effects on health status and spirometric     values of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.),     over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.   "
155725|NCT01245543|"     AC480IV will be administered as a monotherapy and then in combination with docetaxel in     patients with locally advanced or metastatic solid tumors for whom there are no standard or     curative therapies available. It is designed to evaluate the safety and pharmacokinetic     parameters of AC480IV as monotherapy and also in combination with docetaxel under the     conditions of the study.   "
155726|NCT01245530|"     The purpose of this study is to evaluate the efficacy and safety of two fixed dose     (1200mg/day, 1600mg/day) of INM-176 (a drug of treating dementia) comparing with donepezil     for treatment for patients with Alzheimer type dementia.   "
155727|NCT01245517|"     Aim:      Dietary Phosphorus Education Program can improve patients' knowledge, attitude and behavior     of phosphorus restriction diet to reduce the risk of hyperphosphatemia and malnutrition of     hemodialysis patients.      Inclusion criteria:      The criteria of subjects are undergoing regular hemodialysis for longer than 3 months at     baseline. Subjects' age range is from 20 to 85 years old. Their baseline serum albumin < 4.0     mg/dL, or serum phosphate > 5.0 mg/dL, are eligible for inclusion.      Subjects will be enrolled into this trial after signed informed consent. We expect to recruit     60 subjects. Patients will be excluded if they had liver cirrhosis, malignant tumor, can't     finish all education sessions and/or can't complete dietary records monthly. We will recruit     a control group into this trial, they are eligible for inclusion but don't want to     participant education sessions.      Intervention protocol:      At baseline, the investigators collect demography and pre-test KAP questionnaires among all     subjects. If subjects were illiterate then investigator will conduct face-to-face interview     and record their answers. Dietary Phosphorus Education is a 6-month program and be     implemented by dietitians and investigators, including education, nutritional counseling and     dietary records monthly.      The first month was intensive weekly education sessions, each 20 to 30 minutes. Second and     third month were monthly education sessions, each 20 to 30 minutes. There are total 6     sessions in this trial. The last 3 months will follow-up periods, will collect anthropometry     data monthly, biochemistry measurements and 3-day dietary records among all subjects. If     subjects were illiterate then investigator will conduct face-to-face interview or     phone-interview to complete each dietary record. Investigator collect post-test KAP     questionnaires, diet behavior questionnaires and satisfaction questionnaires from subjects in     the end of the trial,. If subjects are illiterate then investigators interview subjects and     record.      This is a 6-months trial and retrospective study to collect anthropometry, biochemical     measurements and 3-day dietary records from control subjects monthly.   "
155728|NCT01245504|"     Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may     be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may     require more work by prosthetists to redesign the socket. The aim of this research is to     assess the accuracy of prosthetic sockets manufactured by commercial companies. Determination     of how and where manufacturing errors occur will contribute to better quality of socket fit     for the amputee patient and improve the efficiency of prosthetists who fit the manufactured     products to their patients.      Computer manufactured sockets are made for subjects, then their fits assessed by research     practitioners.   "
155729|NCT01245491|"     The purpose of this study is:        1. To study the effect of whole-body vibration on partial pressure of oxygen in arterial          blood (PaO2), under hypobaric hypoxic conditions.        2. To study the effects of whole-body vibration and hypobaric hypoxia on visual contrast          sensitivity.        3. To se if there is an increase in cytokines and other biomarkers under different          hypobaric hypoxic conditions Our main hypothesis is that whole-body vibration may cause          PaO2 to drop to a lower level, at a given altitude; than would be the case if there were          no vibration present.   "
155730|NCT01245478|"     This will be a retrospective chart review of 200 charts of adult patients who have undergone     a revision TKA at New England Baptist Hospital and who received implant component(s)     manufactured by DePuy Orthopedics. The data will be collected retrospectively after patients     are seen clinically for a minimum of five years after surgery to answer:        1. What is the five-year survivorship of revision a knee prosthesis containing components          manufactured by DePuy Orthopedics among adult revision TKA patients?        2. What patient factors are associated with the need for re-operation after revision TKA          among patients receiving DePuy implant components? How do clinical outcomes change from          baseline over the five-year follow-up after revision TKA surgery?      Data collection will include patient-reported and clinician-reported measures.   "
155731|NCT01245465|"     In this study the investigators aim was to investigate the safety and possible efficacy of     Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the     usefulness of a new online daily symptom registration system.   "
155732|NCT01245452|"     To measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in     early RA patients treated with tocilizumab compared to Methotrexate alone.      The secondary endpoints : analyze the clinical efficacy of Tocilizumab in this population and     correlate the CRE response with other marker (CRP, Hb, DAS, HAQ) and evaluate the safety     profile of Tocilizumab.   "
155733|NCT01245439|"     This open-label study will evaluate the safety, tolerability and efficacy of     RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid     arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current     non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous     infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment     is 24 weeks.   "
155734|NCT01245426|"     This is a randomised, double-blind, placebo-controlled, parallel group study to determine the     efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced expiratory     volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg GW870086X     and 4mg GW870086X. After an interim analysis the trial may; continue to completion using the     original doses, be terminated early, or have a fourth arm added of either 1mg GW870086X once     daily or 3mg GW870086X once daily.   "
155803|NCT01244490|"     For children and adolescents, how does SPD503 compare to placebo for the treatment of     Attention-Deficit/Hyperactivity Disorder (ADHD).   "
155746|NCT01245270|"     Dietary strategies for alleviating health complications associated with type 2 diabetes (T2D)     are being pursued as alternatives to pharmaceutical interventions. Berries such as bilberries     that are rich in polyphenols may influence carbohydrate digestion and absorption and thus     postprandial glycaemia. In addition berries have been reported to alter incretins as well as     to have anti-oxidant and anti-inflammatory properties that may also affect postprandial     glycaemia. This study investigated the acute affect of a standardised bilberry extract on     glucose metabolism in T2D.      Eight male volunteers with T2D controlling their diabetes by diet and lifestyle alone were     given a single oral capsule of either 0.47g standardized bilberry extract (36% (w/w)     anthocyanins) which equates to ∼50 g of fresh bilberries or placebo followed by a     polysaccharide drink (equivalent to 75 g glucose) in a double blinded cross over intervention     with a two week washout period.      This study demonstrates that the ingestion of a concentrated bilberry extract reduces     postprandial glycaemia and insulin in volunteers with T2D. The most likely mechanism for the     lower glycaemic response involves reduced rates of carbohydrate digestion and/or absorption.   "
155735|NCT01245413|"     Aim      The aim of the Athena project is to develop an ostomy product that is softer and more     flexible in order to improve the comfort for people with a stoma.      The present investigation aims at testing how well the new Athena base plate adhere to     perspiring skin both with and without mechanical exposure (cycling) since the ability to     adhere under normal daily activity is an important quality for Coloplast products.      Success criteria:      The investigation is an explorative investigation where the adherence of Athena on perspiring     skin is evaluated. Due to the explorative nature of the study it has not been possible to     define specific success criteria up front. However, the adherence qualities of Athena may not     be significantly reduced compared to SenSura.      Design:      Two groups of men, one group with a colostomy and one group without a colostomy, are     included. The men should be cardiovascular fit, be able to cycle for 1 hour at moderate     intensity and with Athena and SenSura base plates applied on the back and stomach. The     adhesion of the base plates are tested before and after the physical activities.      Population:      The population consists of two groups. Group A: Men in the age of 50-70 without a stoma who     have volunteered. Group B: Men with a colostomy who have volunteered. Both groups should be     cardiovascular fit (cardio investigated), and be willing to cycle for 1 hour at moderate     intensity on an exercise bike.      The Athena test products are non-CE marked, non-sterile, 1-piece ostomy products with a flat     custom cut base plate, a closed bag size midi or maxi with the intended use of collecting     faeces from the colostomy. The comparator product is a Coloplast SenSura, 1-piece ostomy     product with a closed bag. SenSura is CE-marked and launched on the market.   "
155736|NCT01245400|"     The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational     Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to     Allograft.   "
155737|NCT01245387|"     Long-term observational study to assess the safety, efficacy and quality of life of patients     with neovascular age-related macular degeneration (AMD) under Macugen treatment.   "
155738|NCT01245374|"     This study is conducted in Europe. The aim of this study is to compare the easiness of use of     Norditropin NordiFlex® device to the device previously used by patients or parents.   "
155739|NCT01245361|"     Patient with undifferentiated arthritis and the presence of anti-citruline (anti-CCP)     antibodies are at high risk to develop RA. The presence of anti-CCP is associated with a     higher rate of erosion and a higher risk of progressive and severe RA.      The investigators have demonstrated in the CIERA study that MTX/IFX combination therapy is     superior to MTX alone to reduce MRI signs of synovitis and bone edema and is clinically more     effective.      The immunopathogenesis of undifferentiated arthritis is poorly understood. However, synovial     studies from patients with early arthritis suggest that UA and RA may share common     immunopathogenic mechanisms. One biopsy study of asymptomatic joints in patients with early     arthritis demonstrates synovitis in more than half of the joints samples with prominent T     cell and macrophage infiltration, similar to Rheumatoid Arthritis (RA).      Thus intensive treatment with anti-TNF antibodies (infliximab) may have an impact on multiple     immune mechanisms driving synovitis in undifferentiated arthritis and may influence the     clinical outcome.      Recently, Methotrexate has been demonstrated to improve the course of undifferentiated     arthritis and prevent the development of RA. Short regimen of more intensive therapy with     Infliximab could alter the radiological, immunopathological and clinical outcome.   "
155740|NCT01245348|"     The purpose of this study is to validate that SULT4A1-1 status stratification improves     responses to atypical antipsychotics in schizophrenia and to extend these findings into     bipolar disorder.   "
155741|NCT01245335|"     Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed     for proper function. This severe lack of blood flow can lead to painful legs while walking or     at rest and can result in foot sores, ulcers, gangrene, and even amputation. The purpose of     this study is to determine if injections of concentrated bone marrow into damaged tissues     will result in improved blood flow. If successful, this treatment could improve blood flow to     the lower limb, reduce pain, and reduce the frequency of limb amputations.   "
155742|NCT01245322|"     The primary objectives of this study were to characterize lactobacilli of human vaginal     origin and to investigate if more extended antibiotic treatment against Bacterial Vaginosis,     together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore,     to investigate factors that could influence relapse.   "
155743|NCT01245309|"     Scratching the linning of the womb before IVF cycle could increase the chances of having a     baby after an IVF cycle.   "
155744|NCT01245296|"     Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by     increasing the infant's iron endowment at birth. Compared with early clamping, a delay of     around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight.      The results of previous intervention studies on delayed clamping are mixed, and few followed     up infants beyond the perinatal period. All longer follow up studies have been performed in     low income countries. The main objectives, therefore, was to assess whether delayed cord     clamping improves hematological and iron status at 4 respective 12 months of age in a large     sample of full-term, Swedish infants.      The investigators also choose to investigate if the timing of clamping the umbilical cord     could affect rate of infections during the first four months of life and to assess the     infants development at 4 and 12 months of age.   "
155745|NCT01245283|"     The purpose of this study is to determine if a 4 month resistance exercise program can reduce     knee osteoarthritis pain functional impairment and cartilage turnover.   "
155759|NCT01245075|"     The main objective of this study is to assess the efficacy of bilateral deep brain     stimulation (DBS) of the Nucleus accumbens (NAc) as a novel treatment in severe opioid     addiction. The included patients have been treated so far with a substitute in form of     methadone.      Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for     heroin and thus enable the patients to decrease their Levomethadone-dosage substantially.   "
155799|NCT01244542|"     The aim of the investigators project is to explore the mechanisms of pain insensitivity in     patients with schizophrenia, in order to prevent its invalidating consequences. The     investigators will couple methods of experimental psychology with EEG and blood samplings, in     order to distinguish the role of non-painful perception, attention, aversive effects, and     pain expression, and the investigators will explore an original neurobiological hypothesis     regarding the activation of opioid receptors.   "
155747|NCT01245257|"     Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with     alcoholic hepatitis. The liver might play an important role in this stress-catabolism by     increasing the production of urea during the inflammatory process.      The purpose of this study is to examine the regulation of urea synthesis in patients with     alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and     pentoxifylline on this regulation.   "
155748|NCT01245244|"     The aim of the current project is to use a model of painful stimulation of skin, muscles and     internal organs, where it is possible to measure activity in the brain centers that process     pain simultaneously. Magnetic resonance imaging and electroencephalography are combined to     optimize the anatomical and physiological description of brain activation. During     administration of morphine we will identify how different brain areas are affected. This     knowledge will be used to:      1. Understand the mechanisms of morphine to a greater extent than is possible today,     including:        1. to investigate the mechanisms of morphine versus placebo on pain signals in the spinal          cord and brain. This is done by a combination of experimental pain models,          neurophysiological and imaging techniques (EEG and fMRI). This can be achieved as both          subjective and objective measures of the analgesic effect.        2. to examine morphines effect on communication between the centers of the brain that are          involved in painprocessing .        3. modeling of morphine pharmacokinetics (the understanding of what the body does to the          drug, such as. concentration in the blood and the brain), since this is central to          understand the pharmacodynamics (the description of what the drug does to the body and          thus the effect it has).        4. to identify biomarkers that can predict whether healthy subjects respond to morphine by          experiencing an analgesic effect.   "
155749|NCT01245231|"     RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients will respond to     treatment.      PURPOSE: This research study is studying prognostic biomarkers in cell samples from young     patients with acute myeloid leukemia.   "
155750|NCT01245205|"     This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206 and     lapatinib ditosylate in treating patients with solid tumors or breast cancer that has spread     to other places in the body. Akt inhibitor MK2206 and lapatinib ditosylate may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
155751|NCT01245179|"     The goal of this clinical research study is to find out about the safety and effects of a     drug called panobinostat when given to adults with sickle cell disease. Panobinostat is a pan     histone deacetylase (HDAC) inhibitor. HDAC inhibitors have been shown to significantly     increase hemoglobin F induction, which is well documented to improve outcomes in sickle cell     disease. HDAC inhibitors are also known to potently inhibit cell-specific inflammation, which     is a primary contributor to the debilitating effects of sickle cell disease. Given the     relevance of these mechanisms of action in SCD, panobinostat may prove to contribute     significantly to the management of SCD patients, a population in critical need of further     effective treatment options.   "
155752|NCT01245166|"     Type 2 diabetes mellitus is a chronic metabolic disorder which is caused by both insulin     secretion deficiency and insulin action defect. In this type of subjects, fasting     hyperglycemia is the result of the elevated rate of basal hepatic glucose production, and it     is coexisting with hyperinsulinemia.After a meal, the impaired control of hepatic glucose     production by insulin and decreased insulin-mediated glucose uptake by muscle contributed     nearly equally to postprandial hyperglycemia(Scheen, 1997). Type 2 diabetic subjects     experience significant morbidity and mortality from microvascular (retinopathy, nephropathy,     and neuropathy) and macrovascular (cardiovascular disease, stroke, and peripheral vascular     disease) complications. The appropriate treatment and good glycemic control of diabetes is     therefore important and necessary (Vaag, 2006). Evidences suggest that combination therapy     using oral antidiabetic agents with different mechanisms of action may be more effective in     achieving and maintaining target blood glucose level (Turner et al., 2005).There are five     classes of oral antihyperglycemic agents (sulfonylureas, biguanides, α- ucosidase inhibitors,     thiazolidinediones and meglitinides) currently available to improve glycemic control in     subjects with type 2 diabetes, each of which works through a different mechanism of action.     Metformin, a biguanide which has insulin-sensitizing properties, can be used alone or in     combination with other classes of agents. Metformin is the currently the first-choice     treatment in subjects with diagnosed type 2 diabetic subjects and obesity, characterized by     insulin-resistance. Metformin also provides reduction of body weight and ameliorates lipid     abnormalities and is thought to be related to a reduction in hepatic gluconeogenesis (Hundal     & Inzucchi, 2003).Acarbose, the α-glucosidase inhibitor, is approved for the treatment of     type 2 diabetes, and first approved for prediabetes treatment (Chiasson et al., 1994; Breuer,     2003; Chiasson et al., 2002). The drug was launched worldwide as a type 2 diabetes     monotherapy and combination therapy in 1990 which has proven efficacious as first-line     therapy (Coniff et al., 1995) and in combination with sulfonylureas or insulin (Kelley et     al., 1998). Acarbose and metformin are both associated with beneficial effects on     hyperglycemia, hyperinsulinemia, body weight, and, in some studies,triglyceride levels     (Krentz et al., 1994). Because these factors are part of a cluster of risk factors for     cardiovascular disease, combining the two drugs may be useful. In long-term clinical studies,     acarbose has shown a favorable safety profile (Hasche et al., 1999).In combination with     metformin, acarbose has been shown to improve long-term glycemic control (Rosenstock et al.,     1998; Halimi et al., 2000). This study was conducted as a further vestigation into the     efficacy and safety of concurrent use of acarbose and metformin in type 2 diabetes mellitus     subjects.Lotus Pharmaceutical Co., Ltd. intends to initiate Phase III program to investigate     assess the efficacy and safety of metformin in combination with acarbose for type 2 diabetes     mellitus subjects considered inadequately blood glucose control. Since combination tablet of     acarbose and metformin has not yet been approved by the Taiwan DOH, this study is conducted     to evaluate the efficacy and safety of combination tablet of acarbose and metformin in the     treatment of type 2 diabetes mellitus subjects in Taiwan. Acarbose is chosen as an     active-comparator.   "
155753|NCT01245153|"     Urinary incontinence (UI) is a common and worldwide problem.Although pelvic floor muscle     training(PFMT) is the standard recommendation for conservative treatment but some patients     had difficulty doing PFMT. They could not locate the pelvic floor muscles, and so could not     perform the PFMT properly or increase intensity of the exercise. The authors hypothesized     that rectal balloon training(RBT) may improve patients' pelvic floor recognition as well as     it is another option of progressive strengthening of pelvic floor muscle. This study's aim is     to combine RBT with PFMT using the water-filled balloons of Foley catheters   "
155754|NCT01245140|"     The main purpose of this study is to demonstrate the improvement in the skin condition rate     of patients receiving alitretinoin compared to patients receiving placebo.   "
155755|NCT01245127|"     Schnitzler syndrome:      Schnitzler syndrome is a rare disabling autoinflammatory syndrome characterized by a chronic     urticarial rash and monoclonal gammopathy, accompanied by intermittent fever, arthralgia or     arthritis or bone pain. Diagnostic criteria have been established. The disease never remits     spontaneously. Although there is no standard of care, there have been promising developments     in therapeutic options, especially anti-interleukin-1 therapy. Anakinra, a synthetic analogue     of the endogenous interleukin-1 receptor antagonist, has caused rapid clinical remission in     24 patients with Schnitzler syndrome. However, to sustain remission, continuous daily     administration (100 mg sc) is required. The level of monoclonal protein does not decrease.     Side effects of anakinra include painful injection site reactions and neutropenia.      Interleukin-1 and the autoinflammatory diseases:      As a key proinflammatory cytokine mediating local and systemic responses to infection and     tissue injury, interleukin-1 can induce a range of responses, including fever, pain     sensitization, bone and cartilage destruction, and the acute-phase inflammatory response. The     so-called autoinflammatory diseases are mediated entirely by interleukin-1; reducing     interleukin-1 activity brings about a rapid and sustained remission. Autoinflammatory     diseases include relatively uncommon disorders such as familial Mediterranean fever, adult     and juvenile Still's disease, the hyper-IG D syndrome, Behçet's syndrome, the     cryoporin-associated periodic syndrome (CAPS), deficiency of the interleukin-1 receptor     antagonist (DIRA) and Schnitzler's syndrome. Some common conditions such as gout and type 2     diabetes, are also likely to be autoinflammatory diseases.      Canakinumab:      Canakinumab (Ilaris, Novartis Pharma) is a fully human anti-interleukin-1-bèta monoclonal     antibody. Treatment with subcutaneous canakinumab (150 mg) once every 8 weeks was associated     with a rapid remission of symptoms in the great majority of children and adults with CAPS.     Serum inflammatory markers quickly returned to normal. In general, the side effects seen in     this small study (35 patients) were not serious, though suspected infections ware     significantly more prevalent in patients receiving canakinumab than in those receiving     placebo. The prolonged duration of action of canakinumab and low incidence of injection-site     reactions may confer certain advantages over other interleukin-1 inhibitors (anakinra and     rilonacept), since both are frequently associated with injection-site reactions, and both     require more frequent administration (daily for anakinra and weekly for rilonacept).      Canakinumab was approved for the treatment of CAPS by the US Food and Drug Administration in     June 2009 and by the European Medicines Agency in October 2009.      Canakinumab is currently being evaluated for its potential in the treatment of systemic-onset     juvenile idiopathic arthritis, diabetes mellitus, and difficult-to-treat gouty arthritis.   "
155756|NCT01245114|"     Tuebingen High Altitude Ophthalmology Study to investigate the effects of high altitude on     retinal structure and function as well as anterior chamber in regard to acute mountain     sickness.   "
155757|NCT01245101|"     This study will examine whether intensification with raltegravir of a suppressive     antiretroviral regimen in HIV infected patients with poor immune restoration has a beneficial     effect on cryptic viral replication and the immune system. Specifically, the investigators     will examine the effect that raltegravir intensification of ART has on episomal cDNA     frequencies, immune activation, CD4+ cell counts and apoptosis, and markers of microbial     translocation.   "
155758|NCT01245088|"     Pilot trial of open-label chondroitin sulfate 400 mg TID for adult patients with mild to     moderate Crohn's disease. Primary endpoint with be evidence of bilogic effect assessed     through serum and tissue cytokine analysis. Secondary endpoints are evidence of clinical     effect, endoscopic healing, and histologic improvment. Trial duration is 8 weeks.   "
155770|NCT01244932|"     The purpose of this study is to determine the minimum effective volume of local anesthetic     for interscalene brachial plexus block using ultrasound guidance and nerve stimulator     guidance.   "
155760|NCT01245062|"     This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212     to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV     malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample.     Subjects who have received up to one prior regimen of chemotherapy in the advanced or     metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or     MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1     randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy     arm). The primary endpoint for the statistical analysis will be a comparison of progression     free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have     progression on chemotherapy will be offered the option to receive GSK1120212.   "
155761|NCT01245049|"     The purpose of the study is to compare the immunogenicity and safety of a booster dose of     BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a     second dose of PriorixTM, in healthy 3 and 4-year-old children.   "
164745|NCT00005321|"     To address the public health importance of sleep disordered breathing and ultimately reduce     morbidity through information gained from longitudinal, population-based, epidemiologic     studies.   "
155762|NCT01245036|"     From the time sarcoidosis has been described, there has always been a belief that the disease     is in some way related to tuberculosis. If indeed tuberculosis is a causal factor in     sarcoidosis, then the hypothesis can be further reinforced, if anti-tubercular therapy (ATT)     is useful in treatment of sarcoidosis. Very few trials have been conducted in the past but     the results of these trials have been discouraging. These trials were generally small studies     and limited by time bias and used older regimens based on isoniazid, amino-salicylic acid and     streptomycin. In our experience nearly one third of patients who are finally diagnosed to     have sarcoidosis, have received ATT for variable length of time, but its impact of final     outcome of sarcoidosis has not been studied. The aim of this prospective randomized     controlled trial (RCT) is to evaluate the efficacy and safety of Rifampicin and Isoniazid     along with prednisolone compared to prednisolone alone in treatment of Sarcoidosis.   "
155763|NCT01245023|"     Laparoscopic adhesiolysis has been used in treatment of chronic abdominal pain. There has     been only one previous controlled study, that stated laparoscopy alone had the same benefits     than laparoscopic adhesiolysis. The aim of this study is to compare laparoscopic adhesiolysis     with a placebo-procedure in chronic abdominal pain.   "
155764|NCT01245010|"     Research Question: Does replacing Sugar Sweetened (SS) beverages with water consumption     promote a decrease in triglycerides blood levels over 9 months in overweight women? The     primary outcome variable is the triglycerides blood level. In addition, the investigators     will consider as secondary outcome variables the following parameters of metabolic syndrome:     weight, fasting insulin and glucose, HOMA, HDL-cholesterol, systolic and diastolic blood     pressure, and waist circumference. The investigators will also consider as an outcome     variable glycosylated (or glycated) hemoglobin (HbA1c).      Design: Two groups randomized controlled trial, with an intervention group (water and     education provision) and control group (education provision only).      The investigators propose to recruit young adult women aged >18-<45 y who are overweight or     obese (BMI >25 and <39), and consume at least 250 calories per day from caloric beverages     (e.g., includes soft drinks, juices, sports drinks, sweetened tea or coffee, and alcoholic     beverages) The intervention group (water and education provision) will be compared with a     control condition (education provision only). The intervention has been proposed to be     carried out for 9 months period with objective measurements of body weight and fat, total     cholesterol, LDL-C, HDL-C, fasting blood glucose, HbA1C, hydration status, blood pressure,     and 24 hrs dietary recalls at baseline, 3,6 and 9 months   "
155765|NCT01244997|"     IRB4729 Study Hypothesis: Is there a significant difference in the hard and soft tissue     response comparing immediate with delayed implant after tooth removal, with immediate     provisionalization, in maxillary anterior sites.      The purpose of this study is to determine and compare the crestal bone levels as the primary     endpoint variable for implants placed and temporized in extraction sites, to implants placed     into extraction sites after the extraction site has been grafted and healed for 4 months, all     immediately restored with an anatomic provisional restoration.   "
155766|NCT01244984|"     The primary purpose of the study is to assess the safety and tolerability of 52-week teatment     with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder     once-daily in Japanese adult subjects with asthma.   "
155767|NCT01244971|"     The purpose of this study is to investigate the impact of exercise training, Acarbose, and     the combination of exercise and Acarbose on glycemic control, body composition, insulin     sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle     biopsies will be obtain to study gene expression. Our hypothesis is that the combination     therapy will be superior to monotherapy with exercise or Acarbose.   "
155768|NCT01244958|"     Combination of rituximab (RTX) with several different chemotherapeutic regimes has proven     synergistic effects in patients with either lymphoma or autoimmune diseases. First data of     uncontrolled trials with the combination of RTX and leflunomide (LEF) are available.   "
155769|NCT01244945|"     The diffusion of gastrointestinal (GI) chronic diseases is significantly increased during the     last century in western countries. In the USA and Northern Europe, constipation is twofold     the prevalence found in the East and Southern Europe. In Italy, constipation affects up to     15-17% of the whole adult population. Of them, more than half (about 10%) treats this     disorder by assuming laxatives, while the remaining does not even assume drugs. A close     relationship between intestinal environment and bacterial flora has been found. As a matter     of fact changes in the intestinal physiology can modify the composition of bacterial flora as     well as modifications in the intestinal microbiota can modify the physiology of the gut. The     probiotic effects on the GI motility can be due to substances released by bacteria and/or     products of their fermentation. Also, probiotic may indirectly act by the release of     neuroendocrine factors and/or substances released by the immune system. Clinically, it has     already been demonstrated that probiotics exert a positive effect on symptoms and intestinal     habit in constipated IBS patients. In this framework, the idea to perform a long lasting     intervention study in patients with functional constipation treated with probiotics sounds     convincing. The present study is a randomized, double blind, placebo controlled, monocentric     study, concerning the evaluation of efficacy of 3 months administration of Lactobacillus     reuteri DSM 17938 in patients with functional constipation, as defined by the Rome criteria.     Clinical, physiological, hematological and immunologic variables will be evaluated.   "
155771|NCT01244906|"     This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus     following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced     intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease     the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune     reconstitution, thereby improving the safety of the procedure. The past experience with     post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism,     which the investigators hope will translate into improved disease control through the well     documented graft-versus-malignancy effects of donor T cells.   "
155773|NCT01244880|"     To evaluate whether PF-02545920 reduces the effects of ketamine on brain activation during     causal learning as measured by fMRI compared to placebo in healthy human subjects, and to     evaluate whether behavioral measures of abnormal causal learning under ketamine are reduced     by treatment with PF 02545920.   "
164868|NCT00005444|"     To investigate familial patterns of hypertension and related cardiovascular (CV) risk factors     in the United States and Nigeria.   "
155774|NCT01244867|"     The primary objective is to assess the immunogenicity and safety and tolerability of two     consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in     part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®,     compared to the placebo, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80).   "
155775|NCT01244854|"     Persons with serious mental illness are at increased risk of cardiovascular disease. The     goals of this study are to test a treatment, Life Goals Collaborative Care to help promote     health behavior change and to get feedback from patients and providers on what is needed to     help better coordinate and physical and mental health care of these patients.   "
155776|NCT01244841|"     In patients with ST elevation myocardial infarction (STEMI)treated with primary percutaneous     coronary intervention (PPCI) a subset with low risk for late complications can be identified.     Early discharge (<72h) of these patients can compromise initiation of prophylaxis,     information and other investigations. The researchers want to investigate prospectively     whether early discharge compared to regular care have comparable patient centered outcomes at     30 days follow-up.   "
155777|NCT01244828|"     This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in     participants with schizophrenia. Participants in this study consist of schizophrenia with     residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory,     or elderly participants with schizophrenia. The treatment period is up to 52 weeks.   "
155778|NCT01244815|"     Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed     episodes) will be evaluated in participants between 10 and 17 years old, who are either     hospitalized or non-hospitalized. In this 3-weeks, double-blind, parallel design trial,     eligible participants will be randomized to receive one out of three fixed dose levels of     asenapine, or placebo. The study primary hypothesis is that at least one asenapine dose is     superior to placebo as measured by the change from baseline to Day 21 in Young Mania Rating     Scale (Y-MRS) total score. Trial medication and placebo are provided as identical-looking     sublingual tablets; concurrent use of psychotropics is prohibited, except use of short-acting     benzodiazepines and psychostimulants approved for the treatment of attention deficit     hyperactivity disorder (ADHD). Main treatment effect is measured using Y-MRS and safety is     evaluated using the recordings of adverse events, routine blood panels, physical examinations     (including vital signs), and electrocardiograms. Participants who complete the double blind     trial may be offered to continue (open-label) treatment with asenapine for an extended period     of time. Follow-up information on safety parameters will be collected in all participants     within 30 days following treatment discontinuation.   "
155779|NCT01244802|"     The objective of this study is to study immune memory generated against the yellow fever     (YFV) vaccine in participants who have previously received the vaccine. Volunteers will not     receive vaccine shots; only immune responses to previous yellow fever vaccination will be     studied. The study involves one or multiple blood draws.   "
155780|NCT01244789|"     Patients with stage 1 & 2 endometrial cancer are treated with surgery. Despite the fact that     disease is confound to uterus, unfortunately some of these patients may relapse and die of     their disease. Postoperative radiotherapy cannot improve survival. Chemotherapy has shown     survival benefit in more advanced stage disease (stage 3 & 4).      This study evaluates if one can improve survival in intermediate and high risk early-stage     patients by offering them postoperative chemotherapy. This is a randomized phase 3 trial     where effect of postoperative chemotherapy is compared with postoperative observation alone     (standard strategy).      Substudy: Translational research   "
155781|NCT01244776|"     This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular     corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.   "
155782|NCT01244763|"     The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the     correction of anemia in non-dialysis chronic kidney disease patients.   "
155783|NCT01244750|"     The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI)     in patients newly diagnosed with CML and their quality of life in a real-world setting.   "
155784|NCT01244737|"     Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is     important in the management of these tumors, but current imaging methods have limitations in     providing the necessary information for optimal treatment of these patients. The goal of this     study is to evaluate the potential utility of positron emission tomography (PET) with     3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in     children. Funding source - FDA Office of Orphan Product Development (OOPD)   "
155785|NCT01244724|"     The primary objective will be to pilot the use of escitalopram for the treatment of major     depression in patients with epilepsy. The secondary objectives will be to determine effect     sizes on scales measuring depressive symptoms, physical symptoms, psychosocial function and     quality of life, and to evaluate safety in the population of patients with epilepsy.      These results will be used to evaluate the possibility of a future double-blind, placebo     controlled RCT of escitalopram for the treatment of major depression in patients with     epilepsy.   "
155804|NCT01244477|"     Traumatic experiences can have a profound negative effect on the lives and well-being of both     the people who experience them and their loved ones. For those who experience post-traumatic     stress disorder (PTSD), their interpersonal difficulties and social support further impact     the success of treatment such that interpersonal difficulties are associated with mistrust     and predict poor treatment outcome. In this proposal, the investigators use functional     neuroimaging to understand the neurobiology of trust and mistrust in people with PTSD and to     learn more about how successful treatment can improve trust and social functioning.   "
155805|NCT01244464|"     This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in     China.      Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™     administered at 2, 3, and 4 months of age in population aged over 2 months old living in the     study city China.   "
155934|NCT01242774|"     This study will be conducted to assess the maximum tolerated dose (MTD) of panobinostat given     3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with     induction chemotherapy (idarubicin and cytarabine) in newly diagnosed patients with a     cytopathologically confirmed diagnosis of high-risk AML, and to investigate the safety of the     combination in this regimen.   "
155787|NCT01244698|"     Antibiotics are used routinely in postoperative tissue expander based breast reconstruction     (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are     also used routinely in immediate breast reconstruction to prevent fluid accumulation and     seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution     since drains can be a source for infection by creating open channels to outside contaminants.     Plastic surgery patients without closed suction drainage devices are usually not placed on     prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is     recommended for up to 24 hours only. These recommendations do not take into account the     increased risk of indwelling closed suction drains. A recent survey of plastic surgeons,     conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to     extended outpatient administration following TE breast reconstruction.      The study plans to prospectively enroll patients who will undergo immediate breast     reconstruction with TE or AF based breast reconstruction. Using the above data and the     current protocol, the investigators will investigate the optimal antibiotic discontinuation     period for these patients. The investigators hypothesize that the use of 24-hour     perioperative antibiotics in TE or AF based immediate breast reconstruction with closed     suction drainage, does not result in an increased infection rate compared to prolonged     postoperative antibiotic administration.   "
155788|NCT01244685|"     The purpose of this study is:        -  To determine if the intraoperative fluid administration with the Deltex CardioQ          esophageal Doppler will reduce the length of stay after elective bowel resection.        -  The probe can be used to dynamically measure stroke volume and cardiac output. This          information will assist us in determining the ideal amount of fluids to be administered.        -  To determine if the fluid administration established by the esophageal probe will result          in a shorter length of stay in elective bowel resection patients.        -  The investigators plan to enroll 100 patients in this study.   "
155789|NCT01244672|"     The purpose of this study is to compare the frequency and severity of postoperative( after     surgery) pain between two surgical techniques for treating severe hemorrhoids. The two     techniques are called: transanal hemorrhoidal dearterialization (THD) and standard surgical     excision (removal) of the hemorrhoids   "
155790|NCT01244659|"     Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS     and Prograf® in post renal transplanted patients.   "
155791|NCT01244646|"     1. A prospective, non-interventional study, 125 patients with Diabetes Mellitus Type2 will          be enrolled, who, while on metformin, have a sub-optimal glycemic control and who thus          will receive additional treatment with a sulfonylurea (SU) derivative. At the start and          at 3 and 6 months, during regular visits to the patient's General Practitioner, the          patients will complete a series of questionnaires (Patient Reported Outcomes, PROs)          directed at diabetes in general, at fear for hypoglycemia, at body weight, at treatment          compliance and at general wellbeing. These PROs are the worry subscale of the          Hypoglycaemic Fear Survey, Impact of Weight on Quality of Life, revised Diabetes Symptom          Checklist, Problem Areas In Diabetes, EuroQol EQ-5D and Medication Adherence Report          Scale. In total 75 questions. The frequency of hypoglycemic symptoms, incidence of          hypoglycemic events and body weight changes will be assessed and the level of adherence          to treatment will be investigated.        2. Diabetic patients, M/F, aged >35, metformin treated, serum HbA1c ≥7.0% (within last          month), informed consent provided, in whom a SU therapy is added. Patients with Type 1          diabetes and with secondary diabetes will be excluded, and patients unable to understand          and complete the questionnaires.        3. Primary outcome variables are outcomes from HFS-w and IWQOL in relation to the frequency          of hypoglycemic symptoms and body weight at 6 months and to weight change from 0 to 6          months. Secondary outcome variables are the other PROs. The frequency of hypoglycemic          symptoms, incidence of hypoglycemic events, changes in body weight and level of          compliance will be addressed.        4. The Intention To Treat analysis will be used, with Last Value Extended Forward from 3 to          6 months in case of withdrawal after 3 months. Changes in outcome variables will be          analysed by modelling time and potential dummy variables in a Generalized Estimating          Equations analysis.        5. Secondary, outcomes in HFS-w and IWQOL are compared with self-reported hypoglycemic          symptoms, incidence of hypoglycemic events, body weight and change in body weight from 0          to 6 months. Changes in all PRO's from 0 to 3 and 6 months, potential relationships          between (changes in) the different questionnaires, such as with hypoglycemia symptoms,          weight (changes) and treatment compliance will be evaluated. A search is done for          baseline characteristics which predict outcomes and changes in PRO's, hypoglycemic          symptoms, hypoglycemic events and weight changes.   "
155792|NCT01244633|"     Tourette's Syndrome is a neurological disease characterized by verbal and motor tics. The     currently available drug treatments are considered to be inadequate. This clinical trial is     designed to test if ecopipam is effective for the treatment of Tourette's Syndrome in adults.   "
155793|NCT01244620|"     Sitaxsentan has a low drug-drug interaction potential and it did not have a clinically     relevant effect on pharmacokinetics of sildenafil (a CYP3A sensitive substrate and PDE5     inhibitor).      Tadalafil did not have clinically relevant effect on pharmacokinetics of bosentan and     ambrisentan. Based on overall clinical drug-drug interaction profiles, and in vitro CYP     enzymes and transporter data, a clinically relevant drug-drug interaction between sitaxsentan     and tadalafil is not expected. Sildenafil is not expected to affect sitaxsentan     pharmacokinetics (PK), as sitaxsentan is a substrate of CYP3A4 and CYP2C9, where sildenafil     did not show clinically relevant effect on PK of substrates of CYP3A4 and CYP2C9.   "
155794|NCT01244607|"     The purpose of the study is to assess the effect of a single dose of NI-0801 on the severity     of nickel-induced allergic contact dermatitis.   "
155795|NCT01244594|"     Background:      People with spinal cord injury (SCI) are at risk for many health conditions, some of which     can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one     way to obtain exercise after SCI. However, cycling with FES has only been done one way, which     involves pedaling more quickly with less force to work against. Pedaling more slowly would     allow the person to work against more force, which may lead to greater improvements in bone     mineral density and muscle size. It may also lead to greater changes in bone make-up, body     fat, and cholesterol levels. All of these improvements may lead to a decrease in bone     fractures and cardiovascular disease, two major medical issues that exist in the SCI     population. Study Aims: This study will compare the outcomes on bone, muscle and     cardiovascular health between the commonly used method of pedaling more quickly to a new     method of pedaling more slowly. Both groups will work against the maximal force possible. It     is expected that the group pedaling more slowly will work against greater force and thus will     have improved outcomes compared to other group pedaling faster. Methods: Twenty people with     SCI, ages 18-65 years, will be randomly assigned to a treatment group and will participate in     three 60-minute sessions per week for 6 months at an outpatient rehabilitation center. All     subjects must have complete paralysis of both legs, but may have sensation preserved. Before     and after 6 months of exercise, subjects will have an MRI scan to assess muscle size and     bone, a dexascan to assess bone, a strength test using electrical stimulation to assess     muscle force, an analysis of fat free body tissue, and lab work to measure cholesterol, bone     factors that provide insight into bone change, and nutritional status. Relevance: If the     protocol of pedaling more slowly results in greater improvements, this technique can be     applied to clinical practice. Some people with SCI have FES cycles in their homes and many     have been cycling for many years. This new technique may allow them to obtain more benefits     than what they currently are receiving from FES cycling. In addition, it is important to     maintain overall bone, muscle and cardiovascular health so that people with SCI are health     and ready when spinal cord regeneration becomes clinically available.   "
155796|NCT01244581|"     The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating     acute otitis media in children. The primary end point is time to disappearance of middle ear     effusion which monitored by daily tympanometry performed by families and study physicians.   "
155806|NCT01244451|"     In the last ten years there have been significant developments in CLL treatment. The advent     of fludarabine, rituximab and the association of chemo-immunotherapy have substantially     increased overall response rate, CR rate, time to progression and may also have an impact on     overall survival.      Even though, CLL remains incurable and all patients eventually relapse and progressively     become resistant to treatment. The development of an effective therapy that is not     cross-resistant with the ones currently available as front-line treatment, is one of the     clinical unmet needs within CLL.      BendOfa is a non comparative phase II trial designed to determine the therapeutic benefit of     bendamustine given together to ofatumumab in relapsed or resistant patients with CLL.      Bendamustine is approved by FDA for CLL treatment, it is an hybrid drug with alkylating     agents and purine analogue properties that may lack of cross resistance with fludarabine. It     was utilized in CLL as a single agent and its association with rituximab is currently under     clinical investigation.      Ofatumumab is a new fully human anti-CD20 monoclonal antibody with high in vitro efficacy on     CD20 low-expressing CLL cells. An early report showed that ofatumumab in single therapy is     effective in highly pre-treated refractory CLL patients.      Both drugs were generally well tolerated without unexpected untoward toxicity. On the basis     of these data, bendamustine and ofatumumab could be a new effective and well tolerated     combination for patients with relapsed and refractory CLL.   "
155807|NCT01244438|"     An open-label, non-randomized, single arm study to assess the safety, tolerability, and     pharmacokinetics of FP-1039 given by weekly intravenous (IV) administrations in advanced     endometrial cancer patients with FGFR2-specific mutations. FP-1039 will be dosed weekly     starting at a dose of up to 16 mg/kg.   "
155808|NCT01244425|"     The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor     Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding     (i.e. oozing) in hepatic resection surgery when standard surgical techniques are     insufficient.   "
155809|NCT01244412|"     This is the proof of concept study to evaluate the performance of an early stage prototype of     a hand-held fundus camera.   "
155810|NCT01244399|"     Neural Tube Defects (NTDs) are multifactorial (genetic/environmental) diseases that arise     from failure of embryonic neural tube closure. Several studies have demonstrated that     periconceptional administration of folic acid can prevent approximately 70% of all NTDs     cases. The finding of several NTDs cases in a single family, despite prophylactic therapy     with folic acid, suggested that a proportion of human NTDs are folate-resistant. So far, no     preventive therapy for folate-resistant NTDs is available. Studies performed on     folate-resistant NTDs animal models have shown that inositol is effective in preventing NTDs     occurrence. Preliminary results in patients with at least two previous pregnancies affected     by NTDs, despite folic acid supplementation, indicate that periconceptional treatment with     500 mg/day of inositol (three months before conception and two months after) is able to     prevent NTDs recurrence in humans.      Recently, caffeine intake (more than 10 mg/day) has been associated with an increased risk of     NTDs, especially for subgroups of people that carry genetic variants for enzymes involved in     caffeine metabolism.      The teratogenic effects of caffeine are known since the 70s. Indeed, gynecologists suggest to     pregnant women to avoid/reduce caffeine intake. It is still unknown, however, whether     pre-conception caffeine intake interferes with prophylactic therapy for NTDs.      In the proposed study, we aim to evaluate the effect of espresso consumption (corresponding     to about 100 mg caffeine) on the pharmacokinetics of oral administered myo-inositol (MI), in     order to highlight any possible negative effects of caffeine on MI adsorption and excretion     before conception.      The study will consist of two phases and will be carried on twelve healthy volunteers. During     phase 1, volunteers will be kept for 15 days under inositol-poor diet; at the end of this     period, 20 g of MI will be administrated in a single dose. Basal levels of serum and urinary     concentration will be evaluated before MI administration (t0); subsequently, sampling will be     performed 2, 4, 6 and 8 hours after MI administration. Phase 2 will consist of 15 additional     days of inositol-poor diet: basal levels of MI will be again measured before MI     administration. In phase 2, MI administration will be concomitant to caffeine exposure     through singleespresso consumption. Samples will be collected at the same time points as in     phase 1.   "
155811|NCT01244386|"     The purpose of this study is to validate the use of a low-dose computed tomography (CT)     protocol and facilitate reduced radiation doses in patients with inflammatory bowel disease     (IBD). This is to be achieved using new computer software (Iterative Reconstruction and     Automatic Tube Modulation) which will enable low-dose CT imaging at doses equivalent to that     of an abdominal radiograph.   "
155812|NCT01244373|"     To describe biocompatibility, postoperative results and complications after implantation of     the Corneal Quatrix Evolutive (Corneal, Croma, Austria) intraocular lens, a hydrophilic     acrylic intraocular lens (IOL) with 4-haptic design and 360° sharp optic edge.   "
155813|NCT01244360|"     The purpose of this study is to examine the effects of resveratrol on health and human     performance. The study will evaluate cognitive function and several indicators of physical     health before and after taking a resveratrol supplement or a placebo for three weeks.   "
155826|NCT01244191|"     This study is to determine if the combination regimen of tivantinib with erlotinib will     improve overall survival relative to erlotinib alone in subjects with locally advanced or     metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic     anti-cancer therapies.   "
155827|NCT01244178|"     Insulin regulates blood sugar and acts to suppress inflammation. Hyperinsulinemic Therapy is     a protocol for Insulin administration that involves the administration of a calculated higher     dose of insulin into the blood stream. This therapy is called dextrose/insulin clamp. It has     been shown to be safe and successful in maintaining normal glucose levels.      The objective of the study is to assess if the clamp can achieve a steady and normal blood     glucose level in patients admitted to the intensive care unit with sepsis. Furthermore, if     the higher insulin dose would lead to a drop in the inflammatory response seen in septic     patients.   "
155828|NCT01244165|"     To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the     treatment of pelvic organ prolapse.   "
179014|NCT00189696|"     This study will examine the efficacy, safety and tolerability of oral dose of YM060, 5-HT3     receptor antagonist, in patients with d-IBS.   "
155829|NCT01244152|"     The primary aim of the study is to design a group-based, culturally appropriate     self-management skills training intervention for disadvantaged African-Americans with both     diabetes and hypertension and to compile an intervention Manual of Operations (MOO). The     investigators are developing an intervention to assist individuals in reducing weight and     hemoglobin A1c.   "
155932|NCT01242800|"     RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative surgery     or radiation therapy may help patients with advanced breast cancer live more comfortably. It     is not yet known whether early surgery is more effective than palliative therapy for advanced     breast cancer.      PURPOSE: This randomized phase III trial is studying early surgery to see how well it works     compared to standard palliative therapy in treating patients with stage IV breast cancer.   "
155814|NCT01244347|"     In 1991 the Medical Research Council Vitamin Study Group and in 1992 the Hungarian randomised     clinical trial have shown conclusively that the risk of neural tube defects can be reduced     substantially by taking folic acid during the peri-conceptional period. At present there is     enough evidence to support the hypothesis that folic acid supplementation can reduce the risk     of all congenital malformations or of a specific and selected group of them, namely: neural     tube defects, oral clefts, cardiac defects, urinary tract anomalies except hypospadias, limb     reduction defects, omphalocele, anal atresia and trisomy 21.      The hypothesis that a higher intake of folic acid is related to an higher risk reduction of     neural tube defects and of other congenital malformations is the main rationale for the     present study.      The present study is a randomized, double-blind, controlled trial evaluating whether     supplementation with folic acid at high dose (4 mg/day) reduces the overall risk of major     congenital malformations in the population more than the standard recommended dose (0.4     mg/day). At the enrolment visit all the eligible women will be interviewed to assess     sociodemographic, life style and health status. After randomization, women will be     interviewed every 4 months to evaluate pregnancy status. Women who have a pregnancy diagnosis     during the study period will be interviewed by telephone at the expected 16, 24 and 40 weeks     of gestation to evaluate the pregnancy outcome. The health status of live births will be     evaluated at the child's age of 1 month, 3 months and 1 year.      The primary aim of this project is conducting a study to assess the effect of folic acid     periconceptional supplementation of 4 mg/day compared to the 0.4 mg/day standard dose on     reducing the occurrence of all congenital malformations. Secondary aims of this study include     comparing severity of CMs in offspring of trial mothers, rates of selected congenital     malformations, rates of twinning, miscarriages, recurrent abortions, small-for-gestational     age, preeclampsia and abruptio placentae. The sample size is not easy to be computed because     lacking robust estimate of the size effect of the treatment. Three hypotheses of a size     effect of 45%, 26% and 13% were considered. A sample size of outcomes (and women)     respectively of 2,006 (5,015), 8,510 (21,275) and 30,126 (75,315) is needed. Since the sample     size needed to evaluate different scenarios is large, the present study is also the pilot     study to promote an international prospective meta-analysis.   "
155815|NCT01244334|"     The purpose of this clinical research study is to investigate the efficacy of predosing     patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic     emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal     thickness.   "
155816|NCT01244321|"     The objective of this controlled, non-randomized, single-center pilot study (CoSeal arm     prospective)study is to evaluate the efficacy of the synthetic surgical hydrogel CoSeal® in     the prevention of cardiac adhesion formation in patients submitted to VAD procedures.   "
155817|NCT01244308|"     It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for     avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.   "
155818|NCT01244295|"     A comparison study of 16 week treatment with either specialized psychotherapy for complicated     grief (CGT) or with standard interpersonal psychotherapy (IPT) in older adults with     complicated grief.   "
155819|NCT01244282|"     This study will identify a dose of ferumoxytol that can reliably detect changes in blood     flow/volume in response to non-drug stimuli. The study will determine whether signal     detection for functional magnetic resonance imaging (fMRI) using ferumoxytol is better than     that for blood oxygen level-dependent (BOLD) fMRI in response to sensory stimulation. The     following procedures will be conducted in each of two study periods: arterial spin labeling     (ASL) imaging study with increasing exposure to carbon dioxide (CO2); BOLD fMRI study with     sensory stimulation; MRI studies with sensory stimulation in the presence of increasing doses     of ferumoxytol; MRI study with increasing exposure to CO2 in the presence of ferumoxytol.     There will be a 3-week interval between the two study periods. The study will enroll 8     subjects, but an additional 4 subjects are permitted to enroll to preserve study power.   "
155820|NCT01244269|"     This project aims to determine if methylphenidate can improve deficits in attention and     symptoms of orthostatic hypotension, two common non-motor symptoms, in patients with     Parkinson's Disease. This project also seeks to evaluate the effect of methylphenidate on     postural control in these patients, a debilitating motor symptom that places patients at an     increased risk of falling. This study will build on existing data to support a new indication     for the use of methylphenidate in Parkinson's Disease. Using standard and objective     evaluations, this study will quantify the effect of methylphenidate at two doses on attention     levels, orthostatic hypotension, and measures of postural control. Phase I of the study will     compare methylphenidate 10mg three times daily to placebo and Phase II of the study, for     those tolerating the lower dose in Phase I, will compare methylphenidate 20mg three times     daily to placebo. By incorporating two different doses, the study also seeks to determine if     any improvements are dose-related. Secondary endpoints will include safety assessments     (adverse event monitoring and vital signs) performed every 30 minutes following supervised     drug administration. Visual analog scales will be presented to each participant before     treatment and following the final dose of each treatment to assess changes in fatigue. A     secondary task will be added to postural tests to assess the influence of cognitive     processes. It is hypothesized that methylphenidate will demonstrate a significant beneficial     effect on all outcomes. It is projected that objective improvements will be observed     following treatment with methylphenidate at both doses (10 and 20mg three time daily) when     compared to placebo. It is further hypothesized that the effects will be dose-related and     therefore more profound with higher doses.   "
155821|NCT01244256|"     The objective of this trial is to evaluate the comparative efficacy of the combination of     Clotrimazole + Gentamicin + Beclomethasone in study subjects with a condition of contaminated     dermatosis showing bilateral symmetrical lesions.   "
155822|NCT01244243|"     The purpose of this study is to develop and assess the effectiveness of robot-assisted     movement therapy in enhancing hand motor function in subjects with chronic hemiparetic     stroke, and to identify predictors of treatment response.   "
155823|NCT01244230|"     Primary Objective:      To evaluate safety (4 weeks)      Secondary Objectives:        -  To evaluate the long-term safety (12 weeks)        -  To evaluate the efficacy        -  To characterize the pharmacokinetic profile   "
155824|NCT01244217|"     Primary Objective:      - To evaluate safety (4 weeks)      Secondary Objectives:        -  To evaluate the long-term safety (12 weeks)        -  To evaluate the efficacy        -  To characterize the pharmacokinetic profile   "
155825|NCT01244204|"     The investigators proposed a pilot study preparatory to developing a randomized trial of     vitamin D for the prevention of TB infection. The specific aims are presented below:        1. To recruit subjects, obtain consent, distribute vitamin D supplements to the children in          the schools, obtain blood samples and transport them to the United States.        2. To test the hypothesis that daily vitamin D supplementation will increase plasma levels          of 25(OH)D, and restore TLR-induced antimicrobial activity in monocytes/macrophages          tested in vitro.   "
155895|NCT01243294|"     The objective of this investigation is to evaluate leakage, handling and comfort of a new     ostomy appliance compared to SenSura.   "
155830|NCT01244139|"     The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic     profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with     MS.      Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups     (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of     BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will     review all safety data from previous groups enrolled, as well as data from another study     where BIIB033 is being administered to healthy volunteers (215HV101).   "
155831|NCT01244126|"     The purpose of this study is to compare the difference in effect of three clinically common     methods of providing pain medication during surgery for ventilating tubes placed for     recurring ear infections.The methods are fentanyl dripped in the nose, morphine injected in a     muscle, and morphine injected in a vein.   "
155832|NCT01244113|"     The children with CP has been shown different drug responses from the normal population of     children and it may related with a various oral medications such as baclofen, tizanidine,     diazepam, dantrolene, or anticonvulsant drugs.      The aim of this study is to establish the optimal induction dose of propofol for deep     sedation to start MRI for < 30 min in children with CP.   "
155833|NCT01244100|"     This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.   "
155834|NCT01244087|"     The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie     (www.thework.com), trains subjects to reduce their perceived level of stress by self-inquiry     of their thoughts and beliefs connected to stressful circumstances or symptoms. This     meditative process, named The Work, enables the participants to identify and question the     stressful thoughts that cause their suffering. The core of IBSR is simply four questions and     a turnaround, which is a way of experiencing the opposite of what the participant believes.     This process is simple, powerful and can be easily implemented in daily life.      Therefore, on the basis of previous data and beneficial observations the investigators     postulate that the clinical utility of IBSR mediation program may improve psychological and     physical symptoms and quality of life among BC patients during the survivorship period. Thus,     we will conduct a pilot/feasibility randomized controlled clinical trial designed to        -  Assess feasibility of a IBSR intervention by examining attendance, drop-out rates, and          program satisfaction.        -  Determine whether IBSR intervention compared with usual care is efficacious in improving          quality of life, psychological and physical status in BC survivors.   "
155835|NCT01244074|"     The Visual Pathfinder (LACE inc.) offers a non- invasive, patient- centered visual     rehabilitation system based on an acoustic biofeedback. The investigators wanted to evaluate     its usefulness in the improvement of visual function in visually impaired patients with high     myopia.   "
155836|NCT01244061|"     The main purpose of this study is to compare the effectiveness and safety of the re-treatment     of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a     12 week course of treatment. The study will also assess whether smokers remain abstinent at     Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of     treatment).   "
155837|NCT01244048|"     The effective dosage of a n3-LC-PUFA intervention (with n3 LC-PUFA-enriched yoghurt) on the     modulation of cardiovascular risk factors and inflammatory biomarkers were determined.   "
155838|NCT01244035|"     This is a two part study comprising sequential double-dummy, placebo controlled 3-period     randomized crossover studies. The study will evaluate the safety, tolerability,     pharmacokinetics, and pharmacodynamics of different doses and dose regimens of MK-8266.   "
155839|NCT01244022|"     Based on our previous research, this study aims to determine reliable surgical stress     response markers in patients undergoing radical resection of colorectal cancer.   "
155840|NCT01244009|"     This study will investigate the efficacy and safety of MK-4827 in participants with relapsed     mantle cell lymphoma (MCL) and in a subset of participants with inactivation of the     Ataxia-Telangiectasia Mutated (ATM) gene.   "
155841|NCT01243996|"     The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher     than those actually recommended might increase the closure rate in preterm infants with     gestational age <29 weeks without increasing the occurrence of associated adverse effects. To     assess this hypothesis the investigators planned a multicenter randomized controlled study to     compare the effectiveness of the current ibuprofen regimen to that of a high-dose regimen in     closing PDA.   "
155842|NCT01243983|"     The primary objective of this study is to assess the safety and efficacy of voclosporin as     therapy in subjects with active noninfectious uveitis involving the intermediate and/or     posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or     pan-uveitis).   "
155843|NCT01243970|"     ECG changes during caesarean section are common. Incidence of ST depression on the ECG is up     to 81% in some studies. Although this may indicate inadequate oxygen supply to the heart     muscle (myocardial ischaemia) many other theories have been suggested including air entering     the circulation from the placental bed, high heart rate, hormone or nervous system influences     and spasm of the coronary blood supply. Perioperative ST depression often reflects an     imbalance between heart muscle oxygen supply and demand. At the time of delivery, high heart     rate is common and there is a further increase in the amount of blood the heart has to pump     every minute due to blood coming back to the circulation from the placental bed. This     increases oxygen demand and most ST changes are seen at the time of delivery or within 30     minutes. The clinical significance of these changes is much debated, and apart from a few     case reports do not appear to be associated with poor heart muscle function or ischaemia     (lack of oxygen supply). Management of the mother's blood pressure during caesarean section     has changed greatly in recent years. Intermittent boluses of ephedrine, given when blood     pressure is low, have been replaced with prevention of low blood pressure and phenylephrine     has become the drug of choice. Ephedrine increases heart rate and contractility of the heart     muscle and is likely to increase oxygen demand. Phenylephrine reduces heart rate while     maintaining blood pressure which may result in a more favorable oxygen supply demand ratio.      The investigators aim to compare the incidence of ECG changes if the mother's blood pressure     is maintained with phenylephrine as compared to ephedrine. To see if these ECG changes are     associated with myocardial ischaemia, the investigators will perform troponin T analysis     after delivery. Troponin T is a molecule released by ischaemic heart muscle.   "
155897|NCT01243268|"     This is a prospective, observational, open-label, multi-center study, which will provide     detailed information about the safety and efficacy of Twynsta tablets in Korean hypertensive     patients requiring combination therapy. This will present a convenient treatment option for     hypertension in Korean patients.   "
155933|NCT01242787|"     The purpose of the study is to investigate the long-term safety and the antiviral activity of     the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic     hepatitis B infection compared to entecavir 0.5 mg.   "
155844|NCT01243957|"     The purpose of this study is to measure if there is any difference in how the body breaks     down or inactivates either fluoxetine or LY2216684 when both of these medicines are given     together. This study will look at how fluoxetine might affect LY2216684 and how giving     LY2216684 might affect fluoxetine in the body.      The duration of study participation in this study is approximately 36 days not including the     screening appointment. This study requires 1 research unit confinement of 29 days/28 nights     followed by 1 outpatient appointment. A screening appointment is required within 30 days     prior to the start of the study.   "
155845|NCT01243944|"     This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of     ruxolitinib (INC424) to Best Available Therapy (BAT) in subjects with polycythemia vera (PV)     who are resistant to or intolerant of hydroxyurea (HU).   "
155846|NCT01243931|"     Optical Coherence Tomography (OCT) machines are non-contact instruments that can measure the     depth of scars and other causes of cloudiness in the front of the cornea. The purpose of this     study is to determine whether OCT-guided settings for the lasers used for removal of corneal     scars and other partial-thickness corneal defects result in improved vision in patients     receiving these procedures.   "
155847|NCT01243918|"     The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery     system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non     invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen     therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will compare the     successive use of systems Optiflow®/Non invasive ventilation.   "
155848|NCT01243905|"     The purpose of this study is to examine the effectiveness of group psychoeducation for the     psychological distress of mothers with the children of high-functioning pervasive     developmental disorder and for their behavior based on disorder traits.   "
155849|NCT01243892|"     This is a Phase IV, open label, case-controlled, observational study to evaluate the     age-adjusted cumulative height velocity in pre-pubertal isolated growth hormone deficient     (IGHD) and idiopathic short stature (ISS) participants receiving daily doses of somatropin     (recombinant human growth hormone [rhGH]; Nutropin) using NuSpin device compared to     historical controls from the national cooperative growth study (NCGS).   "
155850|NCT01243879|"     Calorie restriction extends life span and prevents aging-related diseases in several species.     Odorants from live yeast restrain the beneficial effects of calorie restriction in Drosophila     Melanogaster. The investigators hypothesize that visual and odorous food stimuli impact the     neuroendocrine and metabolic response to starvation in healthy humans.      In this randomized cross-over intervention study 12 healthy, young men will fast twice for     60-hours in the presence or absence of food-related visual and odorous stimuli. At baseline     and on the last morning of each intervention an oral glucose tolerance test (OGTT) will be     performed. During the OGTT blood is sampled and hypothalamic neuronal activity is measured by     functional MRI.   "
155851|NCT01243866|"     Severe dental decay affects children physically, emotionally, socially and thereby impacts on     their quality of life. Evidence from developed countries showed that children with severe     dental decay weighed less than their peers and following dental treatment children's growth     and quality of life improved. This suggests that treatment of severe dental decay may enhance     growth and wellbeing. A study was carried out in Saudi to test that hypothesis.   "
155852|NCT01243853|"     The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in     alleviating the symptoms of irritable bowel syndrome (IBS).   "
155853|NCT01243840|"     Purpose of the study        1. The predictive value of central aortic pressure and aortic pulse wave velocity (PWV) in          a Japanese population is not known. The purpose of this study is to quantify the          predictive value of these indices in the determination of cardiovascular risk.        2. Recently, a non-invasive method to separate the aortic pressure waveform into the          separate ejection pressure wave and reflected pressure wave has become available. With          this decomposition method, it is possible to estimate aortic PWV (named AVI). The second          objective of this study is to determine if AVI can be a substitute for carotid-femoral          PWV (cf-PWV), the current gold standard for aortic PWV measurement.        3. To study vascular aging of the Japanese population by evaluating central blood pressure          and aortic PWV by age, and compare these values to similar studies done in Caucasian and          Chinese patient populations.        4. To study the relationship between the magnitude of the aortic reflected pressure wave          and the degree of left ventricular (LV) hypertrophy and LV diastolic function.   "
155854|NCT01243827|"     The purpose of this study is to compare of carvedilol, a vasodilating beta-blocker and     bisoprolol, a beta1- selective beta-blocker for reducing the central pulse pressure and     thereby left ventricular (LV) mass in never-treated hypertensive patients.   "
155855|NCT01243814|"     To compare the therapeutic effect of single intra-articular injection of hyaluronate with a     single intra-articular injection of normal saline (placebo) for osteoarthritis of the ankle.   "
155856|NCT01243801|"     Postthoracotomy acute pain is followed by persistent postsurgical pain in 20-30% of the     patients, defined as pain that lasts more than 3-6 months after surgery. Acute pain and     hyperalgesia around the surgical wound are some of the risk factors associated to the     development of chronic pain. Ketamine, as a NMDA antagonist mainly at spinal level, might     reduce periincisional hyperalgesia and persistent postsurgical pain after thoracotomy.     Therefore, the investigators hypothesized that continuous ketamine infusion at subanesthetic     dose would potentiate epidural ropivacaine and fentanyl-induced analgesia after thoracotomy,     reduce periincisional hyperalgesia and long-term postoperative pain. To test these     hypothesis, the investigators administered a low dose of intravenous ketamine or epidural     ketamine or placebo to patients who received an epidural infusion of ropivacaine and fentanyl     for postthoracotomy pain.   "
155857|NCT01243788|"     To determine the efficacy and safety of Salmeterol/Fluticasone Propionate 50/500ug BID vs     Ipratropium/Albuterol 36/206ug QID in Chinese patients with moderate-to-severe Chronic     Obstructive Pulmonary Disease (COPD).   "
155898|NCT01243255|"     The purpose of the survey is to evaluate the efficacy of treatment of hypercholesterolemia in     Polish patients who are currently on lipid- lowering pharmacological therapy . Efficient     treatment is defined as achievement of the LDL cholesterol level goals according to the     European Society of Cardiology 2007 guidlines.   "
155858|NCT01243775|"     Lung cancer is the leading cause of cancer death in Korea as well as in other countries.     About 80% of lung cancer is non-small cell lung cancer(NSCLC). The majority of patients with     NSCLC require cytotoxic chemotherapy in the course of their illness. Combination chemotherapy     using third generation anticancer drugs (paclitaxel, docetaxel, gemcitabine) with     platinums(cisplatin or carboplatin) reached a plateau in their efficacy. Oxaliplatin, another     platinum being used for colorectal, gastric and pancreatic cancer has lower adverse effects     such as nausea and nephrotoxicity. In this phase II trial, we will observe efficacy and     safety of docetaxel and oxaliplatin for patients with NSCLC.   "
155859|NCT01243762|"     This is an open-label, two-part study to evaluate the safety and tolerability of combination     treatment with dalotuzumab + MK-2206, dalotuzumab + MK-0752, or dalotuzumab + MK-8669     (ridaforolimus). The study will determine the dose limiting toxicities (DLTs) observed after     administration of each of the combinations at various doses and define the maximum tolerated     dose of each combination. Preliminary anti-tumor activity of these combinations, in two     groups of participants having selected tumor biomarkers, will be assessed: one group with     metastatic or recurrent platinum-resistant ovarian cancer, fallopian tube cancer, or primary     peritoneal cancer and one group with metastatic or recurrent colorectal cancer. The     dalotuzumab + MK-8669 and dalotuzumab + MK-2206 arms will be enriched with female     platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer     participants. The dalotuzumab + MK-0752 arm will be enriched with metastatic or recurrent     wild-type kirsten rat sarcoma (KRAS) colorectal cancer participants.   "
155860|NCT01243749|"     To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting     Coronary Stent System in a real-world patient population requiring stent implantation.   "
155861|NCT01243736|"     The investigators are conducting a study to see if taking a bowel preparation before having a     capsule endoscopy is more helpful than the standard preparation of not eating after 7 PM the     night before a capsule endoscopy in making it easier to see the small bowel in order to find     the source of gastrointestinal bleeding.   "
155862|NCT01243723|"     The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment     of patients with dyschesia.   "
155863|NCT01243710|"     The purpose of this study is to determine whether taurolidine with heparin locking solution     prevents recurrence of central venous catheter related blood stream infections in     haemodialysis patients.   "
155864|NCT01243697|"     The congenital central hypoventilation syndrome (CCHS), also known as the Ondine syndrome, is     a very rare genetic disorder. In contrast with healthy people, patients do not increase     breathing in response to an excess of carbon dioxide (CO2). As a consequence, they do not     breath sufficiently, or even stop breathing, during sleep. Their survival depends only on     mechanical respiratory assistance, all life long.      We have recently published two cases of recovery of a response to CO2 in patients taking     desogestrel as a contraceptive pill. The goal of the study is therefore to assess the     hypothesis that desogestrel will restore a respiratory response to CO2 in CCHS patients and     allow them to breath sufficiently during sleep without mechanical assistance.   "
155865|NCT01243684|"     This study aims at evaluating spinal cord structure using diffusion tensor imaging in     patients with cervical spondylosis.   "
155866|NCT01243671|"     To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for     Japanese subjects with intestinal Behçet's disease who are refractory to conventional     therapies.   "
155867|NCT01243658|"     RCT. Two substudies (clinical and experimental). Main objective of the trial is to examine if     oxytocin, compared to placebo shows any additional effect on the therapy achievements     (outcome) of patients with borderline personality disorder, who receive an in-patient     standard psychotherapy (Dialectical-behavioral-therapy, Marsha Linehan (2006)).      Secondary objectives :      Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in     patients with borderline personality disorder. Comparison of the effects of Oxytocin on     patients with BPD and major depression.   "
155868|NCT01243645|"     Background:      Biofeedback techniques have demonstrated their uselfulness in the treatment of maculopathies.     We wanted to evaluate the efficacy of visual rehabilitation by means of two different types     of biofeedback techniques in patients with age related macular degeneration (AMD).      Methods:      30 patients bilaterally affected by AMD were enrolled with a mean age of 76,38±8,77 yrs.     Patients were randomly divided in two groups: Group A was treated with an acoustic     biofeedback, Group B with luminous biofeedback of a black and white checkerboard flickering     during the examination. All patients underwent a complete ophthalmological examination.     Rehabilitation consisted in 12 training sessions of 10 minutes for each eye performed once a     week for both groups. Statistical analysis was performed using t- test. P values less than     0.05 were considered statistically significant.      Results:      Group A: visual acuity at the end of rehabilitation had improved, but this result was not     statistically significant (p=0.054), reading speed showed a significant statistical     improvement (p=0.031), as well as the fixation stability (p=0.0023) and single point mean     retinal sensitivity value (p=0.044).      Group B: visual acuity improvement at the end of rehabilitation was statistically significant     (p=0.048), reading speed showed a statistically significant improvement (p=0.024), as well as     fixation stability (p=0.0012) and mean single point retinal sensitivity value (p=0.027).     Final results for both groups were compared and patients in group B showed results which were     statistically more significant.      Conclusion:      A contrast rich flickering biofeedback stimulus showed a statistically significant     improvement in training the patients to modify their preferred retinal locus (PRL) in     comparison to acoustic biofeedback. It is possible that increased involvement of the various     retinal cell populations with visual stimuli create more efficient ganglion cell response     that better utilize the residual retinal function.   "
155869|NCT01243632|"     Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in     mesothelioma patients. However, median survival of this patient group was only about 12     months. With intent to find more effective treatment the investigators performed phase II     study with gemcitabine in low dose (130-250 mg/m2) in 6-hours (prolonged) infusion in     combination with cisplatin in advanced non-small cell lung cancer (Zwitter et al. Anticancer     Drugs 2005;16:1129-34). After favourable experience, the investigators decided to explore     such regiment in patients with malignant pleural mesothelioma (MPM) as well.   "
155870|NCT01243619|"     The purpose of this pilot study is to develop a more advanced software program that will     collect, compare and analyze tumor images for evaluation. Another purpose of this study is to     learn if a new radio-tracer for tumor imaging called 3'-deoxy-3'(18) F-fluorothymidine (FLT)     can improve the evaluation of tumors during a PET/CT scan. This new type of image tracking is     meant to improve the visualization of tumor active and size.   "
155899|NCT01243242|"     The purpose of this study is to evaluate efficacy, safety and tolerability of metadoxine     (MG01CI) extended release formulation for the treatment of adults diagnosed with ADHD   "
179015|NCT00189709|"     To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in     treating patients with invasive candidiasis or candidaemia   "
155871|NCT01243606|"     Anxiety disorders are common, chronic, costly, debilitating to quality of life, and are more     prevalent than any other class of disorders in every country in the world where surveys have     been taken. Deepening understanding of the nature of anxiety and related emotional disorders     during the last decade has revealed that commonalities in etiology and latent structure among     these disorders supersedes differences. At the same time, examination of extant single     diagnosis psychological treatment protocols (SDPs) for these disorders underscores     mechanistic similarities. These findings suggested the possibility of distilling a set of     psychological procedures that would comprise an innovative Unified Protocol for     Transdiagnostic Treatment of Emotional Disorders (UP), and this protocol has now been     developed. If efficacious, the UP may represent a more efficient and possibly more effective     strategy which would render treatment implications of comorbidity, not otherwise specified     (NOS) and subdefinitional threshold anxiety disorder conditions moot.      The investigators now propose an evaluation of the efficacy of the UP in a group of patients     with heterogeneous anxiety disorders by way of rigorous comparisons to existing evidence     based SDPs benchmarked against a wait list control condition, using both statistical     equivalence and superiority analyses. Additional aims include determining the durability of     the UP relative to comparison conditions after treatment discontinuation, and ascertaining     the differential impact of treatments on disorder specific symptoms vs. higher-order     temperamental variables. Further analyses will indicate if changes in these higher order     temperamental variables mediate long-term outcome as preliminary data suggests, and if this     mechanism of action differs among treatments.   "
155872|NCT01243593|"     The purpose of this study is to evaluate the effectiveness of transversus abdominis plane     (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty     surgery in children.   "
155873|NCT01243580|"     Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be     evaluated.   "
155874|NCT01243567|"     This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination     (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never     been previously treated and are at high risk for progression.   "
155875|NCT01243554|"     Observational studies demonstrate that overweight in pregnancy is a risk factor for adverse     pregnancy outcomes as fetal macrosomia, prolonged labor, low Apgar score, shoulder dystocia,     nerve plexus injuries, increased proportion of instrumental deliveries and perineal ruptures.     There is a 2.6 fold risk for gestational diabetes mellitus (fourfold in morbidly obese women)     and a recent study has shown that fetuses of obese mothers develop insulin resistance in     uterus.      Main aims of this study are to assess if regular exercise in pregnancy among obese women can     prevent or influence weight gain; impaired cardiac function in mother and fetus/newborn;     impaired vascular function in mother; insulin resistance/sensitivity; body composition in     mother and offspring; lumbopelvic pain; urinary and/or fecal incontinence; prolonged labor   "
155876|NCT01243541|"     RATIONALE: Cryotherapy may help prevent peripheral neuropathy or nail toxicity in patients     receiving chemotherapy. PURPOSE: This clinical trial studies cryotherapy in preventing     peripheral neuropathy and nail toxicity in patients with breast cancer who are receiving     paclitaxel.   "
155877|NCT01243528|"     The purpose of this trial is to determine whether nutritional status has an impact on     nosocomial infections. Study population are patients undergoing early neurological     rehabilitation.   "
155878|NCT01243515|"     The primary objective of this study is to determine whether a correlation exists between the     Mespere Non-Invasive Central Venous Pressure (NICVP) device for measuring central venous     pressure (CVP), and assessment of CVP via physical examination.   "
155879|NCT01243502|"     K-252a is a potent inhibitor of nerve growth factor (NGF) and therefore has the ability to     inhibit keratinocyte proliferation. K-252a is strongly lipophilic and therefore passes freely     into the cell membranes of keratinocytes and accumulates at a systemic level. In order to     reduce the dermal absorption and reduce the possible long-term systemic toxicity this study     will assess a PEGylated derivative of K-252a named CT327. This approach should improve the     safety profile of the K-252a molecule while maintaining its activity. The primary objective     is to assess the safety and tolerability of single and repeat doses of CT327 when applied     topically to the skin of healthy male volunteers.      The secondary objective is to evaluate the eventual systemic absorption (pharmacokinetics;     PK) of CT327 following single and repeat doses in healthy male subjects.   "
155880|NCT01243489|"     This study on patient's compliance in clinical workaday life aims to assess and to improve     CML treatment in Germany by means of adherence supporting measures and to increase adherence     awareness by physicians and patients.   "
155881|NCT01243476|"     Trial Design:      This clinical trial is a phase III multicenter, randomized, double blind and controlled with     placebo trial and with two arms designed to assess the efficiency and toxicity of the scheme     Lenalidomide versus observation in a series of 60 patients with low risk myelodysplastic     syndrome associated to 5q deletion with anemia (Hb≤12g/dL) but without the need of     transfusion. Patients are randomized in the study in a 2:1 ratio. They will receive treatment     for 104 weeks until progression of the disease, which implies that the patient suffering from     anemia due to myelodysplastic syndrome requires transfusion of at least 2 UCH/56 days (2     months) with a minimum follow up of 112 days (4 months), or unacceptable toxicity.      Disease:      Low risk myelodysplastic syndrome associated to the loss of 5q without transfusion     requirements.      Total number of patients:      In total 60 patients will be included, 40 assigned to the treatment branch and 20 to the     placebo branch.      Calendar:      First patient first visit: February 2010, and Last patient last visit expected in February     2016. (Recruitment was initially expected to take place over a period of 24 months and was     expected to be finished in February 2012, but due to low rate of recruitment it was extended     until the population sample is included in the trial).   "
155896|NCT01243281|"     The outcome of treatment of chronic hepatitis B is determined by viral and host interaction,     thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug     (entecavir) should improve the response rate. In addition, the simultaneous assessment of     viral and host genetic factors associated with SVR may help to identify predictors of     treatment outcomes, which will in turn significant reduce the cost/effect of therapy   "
155931|NCT01242813|"     This trial will assess the safety and efficacy of ACZ885 in patients with active recurrent or     chronic TNF-receptor associated periodic syndrome (TRAPS).   "
155882|NCT01243463|"     More often than not, obesity occurs in tandem with Obstructive Sleep Apnea (OSA), and each     disease effectively perpetuates severity of the other. Surgical weight loss (i.e. bariatric     surgery), and nocturnal, positive airway pressure therapy (PAP) are used to treat the two     conditions separately, and these treatment modalities both present a unique set of challenges     in terms of patient-adherence. Furthermore, the combined effects of these therapies on body     weight and OSA severity are unclear, and require longitudinal investigation. The purpose of     the research proposed herein is twofold: A) To prospectively demonstrate the specific     physiologic/psychological improvements in OSA risk factors and disease severity that occur in     a subset of bariatric surgery patients with OSA, who are being effectively treated with PAP     and furthermore; B) To elucidate differences in postoperative outcomes (weight-loss,     dyslipidemia, OSA severity, comorbidity resolution) between patients who are compliant or     non-compliant with prescribed PAP therapy. The investigators anticipate that results will be     used to develop and streamline approaches to improve pulmonary/sleep-related outcomes in     bariatric surgery patients. Furthermore, this line of research has many implications for     strategies to strengthen the coordination of care between bariatric surgery, pulmonology, and     other clinical sub-specialties that are integral to the postoperative health of these     patients.   "
155883|NCT01243450|"     The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear     Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.   "
155884|NCT01243437|"     Plague is a severe, life-threatening disease. Plague occurs in focal locations worldwide, but     over 95% of human cases reported to WHO are by countries in Africa. The most common clinical     manifestations of human infection are bubonic, septicemic, and pneumonic plague. Untreated     pneumonic or septicemic plague is fatal in over 90% of cases; untreated bubonic plague is     fatal in over 50% of cases. Delayed and ineffectual treatment is a main contributor to     elevated case fatality rates, which can be as high as 40%, and to the development of     pneumonic plague and plague outbreaks.      Streptomycin is considered the treatment of choice, and prompt administration can reduce     mortality to 5% or less. However, streptomycin may cause irreversible hearing loss and     vestibular damage, reversible renal damage, and it is contraindicated during pregnancy.     Tetracyclines, including doxycycline, are considered effective alternatives but they are     bacteriostatic and relatively contraindicated for use in children aged < 8 years and pregnant     women.      Ciprofloxacin is a relatively newer antimicrobial that is used extensively in clinical     practice because of its broad-spectrum antimicrobial activity, excellent tissue and     intracellular penetration, suitability for oral administration, and good overall     tolerability. In vitro and animal studies suggest equivalent or greater activity of     ciprofloxacin against Yersinia pestis when compared with streptomycin or tetracyclines.     However, the efficacy of ciprofloxacin for the treatment of human plague has never been     demonstrated, nor is it FDA approved for this indication.      Since 2004, CDC has collaborated with the Uganda Ministry of Health (MoH) and the Uganda     Virus Research Institute (UVRI) to enhance surveillance, diagnosis, and ecological control of     plague in Arua and Nebbi Districts. Through these efforts, we have collected data on over     2,400 cases of clinically diagnosed plague occurring from 1999 through 2009. In 2008, UVRI     and CDC staff investigated 163 suspect plague cases: 57 (35%) had laboratory-confirmed plague     illness, of which 14 patients (25%) died.      Because plague is a relatively rare disease that mainly affects people living in rural,     impoverished areas, it receives limited attention for research and development of affordable     and sustainable diagnostic and treatment options. However, because plague cannot be     eradicated, and because it causes high case fatality and has the potential for widespread     person to person transmission, continued research should not be neglected.      The objective of this clinical trial is to conduct a randomized, open-labeled,     non-inferiority study comparing the safety and efficacy of ciprofloxacin to doxycycline, the     national treatment standard in Uganda for plague, in patients aged > 8 years. The primary     outcome for this trial will be patient outcome 14 days from enrollment and initiation of     treatment. Patient outcome will be evaluated only for those patients with     laboratory-confirmed plague illness.      Information gathered from this proposed study will help optimize management of naturally     occurring plague in humans in many countries of the world, including Uganda and the United     States, by providing clinicians with more choices for optimal antimicrobial treatment. This     is particularly true in resource limited rural regions such as Uganda where intravenous or     intramuscular injections are less available. Ciprofloxacin currently is being used in Uganda     and other plague endemic areas of the world for treatment of other infectious conditions,     including infectious diarrhea and lower respiratory infections. In Uganda, ciprofloxacin is     widely available in health facilities and local drug shops, and is affordable.   "
155885|NCT01243424|"     The aim of the study is to investigate the longterm impact on cardiovascular morbidity and     mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight     and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated     cardiovascular risk receiving usual care, and compare outcome against glimepiride.   "
155886|NCT01243411|"     This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in     subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21     days before the initial injection of study drug in the first treatment cycle.      After up to four treatment cycles, each subject will be followed for additional safety and     efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36).      After the final injection of each treatment cycle, the investigator will model the plaque in     an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to     <15° after the first, second, or third cycle of injections or if the investigator determines     further treatment is not clinically indicated (eg, adverse events; allergic reaction),     subsequent treatment cycles will not be administered.      Approximately 300 subjects will be enrolled.   "
155887|NCT01243398|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether     gefitinib is more effective than a placebo in treating esophageal cancer.      PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works     compared with a placebo in treating patients with esophageal cancer that is progressing after     chemotherapy.   "
155888|NCT01243385|"     RATIONALE: Metformin hydrochloride may make some enzymes active. These enzymes may block     other enzymes needed for cell growth and stop the growth of tumor cells.      PURPOSE: This phase II trial is studying the safety of giving metformin hydrochloride as     first-line therapy in treating patients with locally advanced or metastatic prostate cancer.   "
155889|NCT01243372|"     RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab     may help doctors understand and predict how well patients will respond to treatment.      PURPOSE: This research study is studying biomarkers in predicting response to cetuximab in     patients with advanced colorectal cancer.   "
155890|NCT01243359|"     This phase I trial studies the side effects and the best dose of sunitinib malate when given     together with bevacizumab in treating patients with kidney cancer or advanced solid     malignancies. Sunitinib malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth or by blocking blood flow to the tumor. Monoclonal antibodies,     such as bevacizumab, can block tumor growth in different ways. Some block the ability of     tumor to grow and spread. Others find tumor cells and help kill them or carry cancer-killing     substances to them. Giving sunitinib malate together with bevacizumab may kill more tumor     cells.   "
155891|NCT01243346|"     This Phase II study is designed to evaluate the antitumor efficacy and pharmacokinetics of     crenolanib (CP-868,596) in patients with D842-related mutant metastatic GIST.   "
155892|NCT01243333|"     The treatment of cancer is increasingly aimed at molecular targets derived from studies of     the oncogenes and tumor suppressors known to be involved in the development of human cancers.     The increased specificity obtained from these new targeted treatments has developed over the     past many decades. From the use of general cytotoxic agents such as nitrogen mustard in the     1940s, to the development of natural-product anticancer drugs in the 1960s including the     Vinca alkaloids and anthracyclines there has been improvements in cancer chemotherapy. Early     in the development process drugs were used that were found to be more cytotoxic to cancer     cells than normal cells. Later developments included the use of specific monoclonal     antibodies and immunotoxins targeted to cell surface receptors. In addition, as our knowledge     of molecular biology increased, specific agents that inactivate kinases in growth-promoting     pathways were used to treat cancer. These newer more targeted approaches have improved the     response rate in cancer and reduced side effects of anticancer treatment but have not yet     resulted in cures for the majority of patients with metastatic disease. There are general     broad classifications of chemotherapeutic drug effects. One of the earliest and still most     utilized are the cytotoxic chemotherapeutic agents.   "
155893|NCT01243320|"     Nanotechnology is the controlled generation and manipulation of matter in dimensions less     than 100 nm. Silver has been used for its bactericidal properties. The investigators propose     to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in human     volunteers to determine the toxicity and to quantify cytochrome P450 enzyme effects of this     solution.   "
155894|NCT01243307|"     The primary objective of this study is to compare the effect of CT327 to placebo against     experimental induced superficial, deep and hyperalgesic pain.      The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain     models.   "
155900|NCT01243229|"     The purpose of this study is to understand the genetic causes of congenital diaphragmatic     disorders (CDD), namely congenital diaphragmatic hernia (CDH), eventration and hiatal hernia.      Specifically, the investigators plan to:        1. Ascertain informative families and sporadic cases with congenital diaphragmatic          disorders and obtain appropriate phenotypic data and genetic material (peripheral blood          and/or diaphragm tissue sample).        2. Localize the gene(s) for CDD to specific chromosomal segments using linkage analysis,          and determine the role of somatic mutations in CDD.        3. Isolate and characterize genes involved in the pathogenesis of CDD.        4. Develop molecular markers that will facilitate accurate diagnosis (including prenatal          diagnosis) and permit correlation of phenotypic variation with specific mutations.        5. Compare RNA-sequencing from tissue samples of children without CDH to those children          with CDH.   "
155901|NCT01243216|"     The investigators are interested in determining the utility of ultrasound of the spine for     labor epidurals or spinal anesthesia for women in labor or having a cesarean delivery. The     investigators hypothesized that in women with poor spinal landmarks that the use of     ultrasound of the spine will improve the process of placing labor epidurals or spinal     anesthetics   "
155902|NCT01243203|"     The Objective of this study is to introduce a practically feasible multifaceted intervention     in the preadmission clinic to help reduce smoking in preoperative surgical patients. The     investigators aim to study the effectiveness of such a program in promoting positive change     in smoking behavior among patients before surgery. The forced abstinence enforced on patients     during hospital stay for their surgery can also be used to help smokers remain tobacco free     long term. A significant percentage of surgical patients will be receptive to smoking     cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52     weeks after starting the treatment.   "
155903|NCT01243190|"     The goal of this clinical research study is to learn if ofatumumab can help to control     CLL/SLL that has not yet been treated. The safety of this drug will also be studied.   "
155904|NCT01243177|"     Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR)     as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint     of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance     between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).   "
155905|NCT01243164|"     Background and Rationale: Mobility impairment is one of the main correlates of decreased     levels of participation in daily and social activities. Mobility disability is often     remediable through the use of assistive technology, of which the wheelchair is arguably the     most widely used and recognizable form. Statistics suggest over 250,000 Canadians use     wheelchairs, the majority of whom are older adults.      Mobility impairment often has psychological consequences that may independently restrict     functioning and participation. Confidence is one such consequence, and according to Bandura's     Social Cognitive Theory, is the belief individuals have in their ability to perform     behaviours to achieve desired outcomes. Furthermore, previous findings have accounted for no     more than 40% of the variance of factors influencing wheelchair mobility and participation.     It is likely that confidence in wheelchair use may account for some of that variance. Recent     findings show that approximately 40% of wheelchair users report having low confidence.      Because confidence is client-specific and modifiable, treatment strategies to address low     confidence in using a wheelchair may lead to greater participation among older adults.      Purpose: The overall goal of this research project is to evaluate the efficacy of the     Wheelchair Skills Training Program on confidence with using a manual wheelchair in a group of     non-wheelchair users.      Objectives:        1. Evaluate the efficacy of the Wheelchair Skills Training Program on improving confidence          with using a manual wheelchair.        2. Evaluate the efficacy of the Wheelchair Skills Training Program on improving wheelchair          performance.        3. Explore the immediate effect of exposure to wheelchair skills (an outcome measure) on          confidence using a manual wheelchair.      Hypotheses:        1. Participants who take part in the Wheelchair Skills Training Program will have          significant improvements in confidence with using a manual wheelchair compared with          those in the control group, as measured by the Wheelchair Use Confidence Scale          (WheelCon)        2. Participants who receive the Wheelchair Skills Training Program will have significant          improvements in wheelchair performance compared to the control group, as measured by the          Wheelchair Skills Test (WST).        3. All participants will have significant improvements in confidence using a manual          wheelchair after exposure to wheelchair skills (during baseline assessment).      Research Method: This study will use 2 concurrent Randomized Controlled Trials to evaluate     the efficacy of the Wheelchair Skills Training Program in younger and older adults. Trial 1     and Trial 2 will employ different recruitment approaches for targeting younger versus older     adults and different inclusion criteria with regard to age of the participants. Otherwise the     research design, protocol and procedures will be the same. Upon completion of data     collection, the data will be pooled and stratified by age (younger adult, older adult) for     analyses.   "
155906|NCT01243151|"     The primary objective of this study is to evaluate the safety and tolerability of repeated     doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an     investigational drug that is currently being studied as a lipid lowering agent.   "
155907|NCT01243138|"     This is a cross-sectional, epidemiological study to determine the prevalence of     cardiovascular risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and     hypertension in patients attending General Practice clinics in the Africa and Middle East     region. A total of 4300 patients will be evaluated. In patients who are found to have     previously been diagnosed with cardiovascular (CV) risk factors such as dyslipidemia or     hypertension, the level of control of their respective conditions will also be evaluated.   "
155908|NCT01243125|"     NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which     exhibits the potential to prevent the growth of urinary pathogens, including Proteus and     others.      The use of a catheter irrigation solution that can prevent biofilm formation and encrustation     leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes,     potentially lower incidence of UTIs, and better patient quality of life.      The study population will include male and female spinal cord injury (SCI) and other     neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have     a recent repeated history of urinary catheter encrustation and/or blockage.      Subjects will receive two treatment regimens: one treatment regimen with NVC-422 sterile     irrigation solution and one treatment regimen with sterile saline irrigation solution. Each     treatment regimen will consist of a total of 8 treatments, with a washout period between     treatment regimens.   "
155909|NCT01243112|"     Purpose and Background The purpose of this research study is to investigate the benefits of     mixing lidocaine and bupivacaine for numbing the skin. Lidocaine and bupivacaine are two     commonly used medications to numb the skin for minor procedures. Lidocaine has a faster     onset. Bupivacaine has a longer duration. They are often combined with epinephrine to     increase the length of action. These medications are used to control pain at the time of the     operation and to decrease discomfort immediately afterward. Participating in the study     involves injection of local anesthetic containing lidocaine, bupivacaine, and lidocaine and     bupivacain with epinephrine at 4 sites on the forearm. Your participation will potentially     improve the administration of these medications in persons undergoing a variety of     procedures. You will be one of approximately 25 healthy volunteer subjects in this research     study.   "
155948|NCT01242579|"     The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and     maraviroc gel and determine whether it is safe for daily use by healthy women in the United     Kingdom   "
155910|NCT01243099|"     The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to     treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is     supported by two different observations: first, when a DES is implanted to treat a BMS     restenosis, stent struts are deployed and drugs are eluted on a soft tissue mostly     characterized by extracellular matrix with a regular surface. In this case stent malposition     is less likely to occur compared to atherosclerotic lesion whose surface is often more     irregular and rich in calcium. Second, patients who develop in-stent restenosis after BMS     implantation are likely to show a more pronounced neointima hyperplasia and, when a DES is     implanted to treat restenosis, reendothelialization is likely to occur earlier. If this     hypothesis was verified, duration of dual antiplatelet therapy could be shortened after DES     implantation on BMS restenosis with a clinical advantage in terms of bleeding risk.     Furthermore, a higher bleeding risk is often a reason for choosing a BMS instead of a DES;     thus, patients presenting with BMS restenosis are likely to have a higher bleeding risk and     to benefit from a shorter period of dual antiplatelet therapy.   "
155911|NCT01243086|"     In the Western World, Age Related Macular Degeneration (ARMD) is a leading cause of     blindness. This disease was once thought to be a natural part of aging, but recent research     has introduced effective treatments. ARMD is related to the body initiating an immune     response in the eye, as if responding to an infection. Vision is impacted as ocular tissue     becomes inflamed and new blood vessels form at the back of the eye, a process called     angiogenesis. In the more severe wet form of ARMD, blood and fluid leak out of the vessels     and impair the eye's structure and function. Many studies have shown that ranibizumab, a drug     that stops the formation of new blood vessels (an anti-angiogenic agent) can delay damage to     the eye and often restore vision. The investigators believe the best drug therapy will also     stop the inflammation. OZURDEX, a steroid drug, has shown the potential to effectively reduce     inflammation in this application. The investigators aim to investigate if patients receiving     a combination treatment of ranibizumab and OZURDEX improve their visual abilities more than     those receiving just ranibizumab treatment alone. Secondarily, the investigators will also     investigate how often patients receiving each drug therapy regime require re-treatment and     how often they experience further vision loss.   "
155912|NCT01243073|"     This is a phase II open-label study of single agent imetelstat in patients with essential     thrombocytopenia or with polycythemia vera who have failed or are intolerant to at least one     prior therapy, or who refuse standard therapy.   "
155913|NCT01243060|"     In recent years, there has been increased focus on cognitive side effects of sleep-inducing     medications that may contribute to unusual behavior during unexpected awakenings during the     night. Concerns regarding these side effects have led to a class Food and Drug Administration     (FDA) warning for all sleep-inducing medications. Almorexant is an experimental     sleep-inducing medication in a new class of medications that is being extensively developed     by multiple pharmaceutical companies. Medications in this class block wake/arousal centers in     the brain that function with proteins called hypocretins. The goal of this study is to     evaluate the impact on cognitive performance of almorexant vs. zolpidem (an approved sleep     aid) or placebo.   "
155914|NCT01243047|"     This is a randomized phase II study comprising of two treatment arms in patients who are     previously untreated for metastatic or recurrent colorectal cancer.   "
155915|NCT01243034|"     The prevalence of metabolic syndrome(MS) among pt's with schizophrenia has been reported to     be high, ranging from 24 to 43% in males and 27 to 52% in females. Schizophrenic patients     with MS have an increased incidence of DM, coronary heart disease and increased mortality     from cardiovascular diseases. Central adiposity is highly correlated with the presence of     hypertension, coronary heart disease, type 2 diabetes, and increased mortality risk. Waist     circumference(WC) is a better indicator of abdominal obesity and a better predictor of CVD     than either BMI or waist-to-hip ratio. However, currently there is no standard location for     the measurement of WC.      Objectives: 1. To compare the magnitude of WC measured at 3 sites ( immediately above the     iliac crest, midpoint between the lowest rib and the iliac crest , umbilical level) in males     and females.      2. To examine the correlation of WC with Triglyceride, cholesterol, HDL, LDL and glucose.   "
155916|NCT01243021|"     At Bispebjerg Hospital we have introduced an Early Warning Score based triage system , called     Bispebjerg Early Warning Score (BEWS), in order to identify critically ill patient on arrival     at the emergency department. The purpose of this study is to validate our triage system.   "
155917|NCT01243008|"     IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent     Lyme disease at early stages of infection after tick bite.   "
155918|NCT01242995|"     The purpose of this study is to evaluate the use of a thin scope/anchoring Balloon endoscopy     system for the medical care of pancreatic and/or biliary disorders.   "
155919|NCT01242982|"     The purpose of this study is to find out the best treatment for subcapital and shaft     fractures of the 5. metacarpal.      It is a prospective randomized multicenter study. Comparing only fractures dislocated more     than 30 degrees.      One group will be operated with intramedullary pins and one group will be treated     conservatively with reduction and then Plaster of Paris for 3 weeks.      All patients will be followed up after 3, 6 and 12 months.   "
155920|NCT01242956|"     The study hypothesizes superiority of the video-based training (observation combined with     motor exercise, video) over motor exercise alone (non-video) and standard rehabilitation     (standard).   "
155921|NCT01242943|"     The aim of this Study Protocol is to provide a basis for the clinical development of     131I-L19SIP as an anti-cancer therapeutic agent, following the promising results of a Phase I     study.   "
155922|NCT01242930|"     This is an open label Phase II study to determine the rate of improvement in response of     patients with previously treated multiple myeloma to imetelstat alone or in combination with     lenalidomide maintenance therapy. This study will include multiple myeloma patients who     either have achieved disease stabilization or who have achieved at least a partial response     (PR) but failed to achieve a complete response (CR) after cytoreductive therapy for multiple     myeloma; ie, have detectable but non-progressing disease and will most likely relapse.   "
155923|NCT01242917|"     This is a randomized, double-blind, placebo-controlled, Phase 2 study to evaluate the safety     and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to     methotrexate therapy.   "
155924|NCT01242904|"     Peritoneal dialysis (PD) is the method of renal replacement therapy used by close to 200,000     end stage renal disease patients worldwide to help replace the functions that are no longer     performed by their kidneys. An important advantage of PD is it offers an alternative to     hemodialysis that can be safely performed by patients in their own homes. In PD, the     peritoneal membrane that lines the abdomen acts as a dialyzer that allows the transfer of     solutes and water between the membrane capillaries and a dialysis solution that is infused     into the peritoneal cavity. PD dialysis solutions typically require high concentrations of     glucose to adequately perform these functions. Over time the continued exposure of the     peritoneal membrane to high concentrations of glucose can permanently damage the membrane.     Icodextrin is a polyglucose molecule that has been developed for use in PD solutions that     does not harm the peritoneal membrane. However, its use can lead to inadequate fluid removal.     Recent research has focused on finding a PD solution, or combination of solutions, that will     maximize the removal of toxic substances and metabolites while maintaining regulation of     fluid and electrolyte balance in the body. A bimodal solution that combines glucose and     icodextrin has been shown in observational studies to be effective and safe. The     investigators propose a randomized, controlled, blinded study that will determine the     effectiveness and safety of this bimodal fluid in a Canadian PD population. The investigators     hypothesize that the use of the bimodal solution during the long (day) dwell will lead to an     improvement in 24 hour ultrafiltration efficiency as compared to usual care using icodextrin     for the long dwell.   "
155925|NCT01242891|"     The main purpose of this protocol is to provide a mechanism for continued access for patients     that would have been enrolled into the primary cohorts of the IDE study.   "
155926|NCT01242878|"     Sickle cell disease (SCD) is an inherited disorder of the red blood cell. It is now the     commonest genetic disorder in the UK and of childhood stroke, with up to 40% of children     having a stroke (clinical or picked up on a scan) by school age. Patients are prone to     develop acute crises necessitating hospital admission and resulting in long-term     complications. Such events result in considerable morbidity, disability and mortality with     its consequent burden on patients, families, the health service and society as a whole.     Doctors have very little ability to predict who will get ill and when and so it is very     difficult to known when and how to administer treatments. Furthermore there is very little in     the way of treatments available and the mainstay of prevention is a chronic blood transfusion     programme which is expensive, requires time off work and school and can be fraught with     complications. This, in a population who is frequently educationally and socially     disadvantaged at the outset. Recent evidence in sickle cell disease and other diseases that     have similar underlying processes, points towards the importance of microparticles     (circulating broken pieces of cells) and the coagulation system as being important. By     comparing levels of these particles and molecules in patients with those found in healthy     volunteers and with other measures known to be important, this study hopes to identify their     role so as to improve the management of these patients and potentially to lead the way for     new therapies. Participants will be required to donate a small amount of blood (1 teaspoon in     the very young, two in older children and adults). The investigators aim to take this sample     where possible when people are having a blood test in any case.   "
155927|NCT01242865|"     The present study is designed to test the feasibility and efficacy of a stand alone self help     program for decreasing stress and anxiety and enhancing quality of life. The intervention     will be offered in the form of a self help book and three handouts with no in-person     instructor time.   "
155928|NCT01242852|"     BACKGROUND: Despite the numerous advances in the field of in vitro     fertilisation/intracytoplasmic sperm injection (IVF/ICSI), there still exists a maximum     implantation rate per embryo transferred of about 30%. Next to the physiological and physic     burden that comes with every IVF treatment cycle, implantation failure also adds up to the     considerable costs associated with ART. Studies have shown, that minor intrauterine     abnormalities can be found in 11-40% of the infertile women with a normal transvaginal     sonography. Detection and treatment of these abnormalities by office hysteroscopy have led to     a 9-13% increase in pregnancy rate. Therefore, it is increasingly advocated to screen all     infertile women on intracavitary pathology prior to the start of IVF/ICSI.      OBJECTIVE: The aim of the proposed study is to assess whether diagnosing and treating     unsuspected intrauterine abnormalities by saline infusion sonography and/or routine office     hysteroscopy prior to a first IVF/ICSI treatment cycle improves the cost-effectiveness of the     fertility treatment.      STUDY DESIGN: Multicenter randomized intervention study. POPULATION: Asymptomatic women,     indicated for a first IVF/ICSI treatment cycle and a normal transvaginal ultrasonography.      INTERVENTION: Participants will be randomized for a (SIS and) hysteroscopy with     treatment-on-the spot of predefined intrauterine abnormalities versus no diagnostic work-up.     In both groups standard IVF/ICSI treatment will be initiated.      PRIMARY OUTCOME MEASURE:      Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of     IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos,     as well as in subsequent cryo/thaw cycles)      SECONDARY OUTCOME MEASURE:        -  Cumulative implantation rate achieved within 18 months of IVF/ICSI treatment after          randomization (obtained in both treatment cycles with fresh embryos, as well as in          subsequent cryo/thaw cycles)        -  Cumulative miscarry rate within 18 months of IVF/ICSI treatment after randomization          (obtained in both treatment cycles with fresh embryos, as well as in subsequent          cryo/thaw cycles)        -  Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment        -  Patient preference and tolerance of a SIS and diagnostic/therapeutic hysteroscopy          procedure        -  Prevalence of unexpected intrauterine abnormalities        -  Diagnostic accuracy of SIS in diagnosing intrauterine abnormalities   "
155929|NCT01242839|"     CACICOL20 is a biodegradable nanopolymer engineered to mimic glycosaminoglycans such as     heparan sulfates. Applied to the corneal lesion, it replaces damaged heparan sulfates in the     matrix scaffold. CACICOL20 binds to matrix proteins such as collagen and cytokines or     endogenous growth factors of the cellular microenvironment. CACICOL20 provides a protective     function and restores the matrix architecture. This produces a suitable spatial environment     for cells to respond properly to the cascade of signals needed for tissue regeneration to     resume.      The ophthalmic solution, CACICOL20, used for corneal ulcers is very well tolerated both     locally and generally, as proved by a pilot study which as been conducted at the Hôpital des     XV-XX in Paris (France). It reduces the pain significantly and increases corneal ulcer     healing (all ulcers treated were resistant to all other usual therapies).      Therefore, the accuracy of a Randomized multicentric double blinded study to evaluate the     efficacy of CACICOL20 versus placebo for chronic corneal ulcer healing has been shown and     will begin mid-may 2010. In this study, CACICOL20 will be applied every 2 or 4 days for 3     months.      The aim of the study is a double blinded comparison of complete chronic corneal ulcers     healing rate within 3 months in 3 groups of patient double blinded randomized between     CACICOL20 instillations distribution and physiological salt solution instillations     distribution.      The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete     closure.   "
155930|NCT01242826|"     This trial is conducted in Asia. The aim of this clinical trial is to investigate the     pharmacokinetic properties (the rate at which the trial drug is eliminated from the body)     after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp     50). In addition, the safety and tolerability of BIAsp 50 will be observed   "
155935|NCT01242761|"     After comparing ultrasound study of rotator cuff injuries that have been evaluated both in     the community and in a hospital-based ultrasound service with actual surgical findings, it is     expected that specialist performed imaging and evaluation will be most accurate and that     those performed in the community will be not accurate enough.   "
155936|NCT01242748|"     A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with     the established therapy Zoladex 3 month implant in patients with prostate cancer.   "
155937|NCT01242735|"     The purpose of this study is to test the effect of a moderate-intensity aerobic exercise     intervention for Obsessive Compulsive Disorder (OCD) patients interested in reducing     symptoms. The investigators expect that this project will contribute much needed knowledge     about the role that aerobic exercise can play in managing the effects of OCD. If     moderate-intensity aerobic exercise is efficacious in helping individuals with OCD manage     obsessions and compulsions, this will establish that aerobic exercise may be a valuable     adjunct to other OCD treatments such as medication and therapy.   "
155938|NCT01242722|"     This study will collect data, from an implanted Cardiac Resynchronization     Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart     failure devices.   "
155939|NCT01242696|"     The goal of the TAXUS™ Element™ Paclitaxel-Eluting Coronary Stent System European     Post-Approval Surveillance Study is to evaluate real world clinical outcomes data for the     TAXUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.   "
155940|NCT01242683|"     Physician-based primary care has thus far failed to address the obesity epidemic. In this     randomized clinical trial of 200 obese patients with heart disease risk factors, the     investigators will evaluate the impact of nurse and dietitian case management on weight loss     and weight maintenance, as an adjunct to physician care. In addition, the investigators will     test the incremental benefit of an environmental support strategy using community health     workers to help patients navigate their home and neighborhood environments to achieve weight     loss. The innovative intervention model developed and evaluated in this project has the     potential to provide a blueprint for successful primary care-based obesity services   "
155941|NCT01242670|"     The purpose of the study is to verify the safety and adequacy of the immune response produced     by a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine and to     demonstrate the consistency of manufacture of 3 separate lots of RRV vaccine.   "
155942|NCT01242657|"     The long term goal of the study entitled Quit & Fit was to revise, evaluate, and     disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not     On Tobacco (N—O—T), with an added physical activity module. The physical activity module was     intended to encourage youth to adopt a more physically active lifestyle. Research showed that     physical activity may increase the odds of smoking cessation. The general N—O—T program goals     are to help adolescents quit smoking; reduce cigarette use (for participants who are unable     to completely quit); increase healthy lifestyle behaviors; and improve life skills such as     stress management, decision making, communication, and interpersonal skills. The primary aim     of the current research project was to reduce smoking among West Virginia teens. A two—prong     secondary aim was to (a) increase participants´ physical activity behavior by supplementing     the intervention with a physical activity component and (b) assess the mediating/moderating     impact of physical activity on cessation outcomes. If participants quit smoking, the     likelihood that they will develop smoking—related diseases is diminished. Participating in     this project may aid smoking cessation and therefore improve participants´ health. Research     was conducted among 19 of the 123 West Virginia public high schools. 236 teens were recruited     to participate in the study over 3 years. This study is a clinical behavioral trial using a     3-group design, with subsequent random assignment.   "
155943|NCT01242644|"     Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as     effective as this solution plus ropivacaine administered intra-articularly for twenty-four     hours.      Three groups were assigned random patients, each group provided a different method of pain     medication in order to determine the effectiveness of each treatment.   "
155944|NCT01242631|"     The purpose of this study is to determine whether the drug everolimus is effective in the     treatment of patients with relapsed cancer of the testis. This is a phase II study where all     patients will receive the study drug (everolimus 10 mg daily). The primary endpoint of the     study is the rate of patients that have no progressive disease after 12 weeks of treatment.     Twenty-five evaluable patients will be treated in this study.   "
155945|NCT01242618|"     The purpose of this study is to investigate the safety and feasibility of implanting an     engineered cartilage graft, obtained by culturing expanded autologous nasal chondrocytes     within a collagen type I/III membrane, in the alar lobule of patients after resection of a     non melanoma skin cancer.   "
155946|NCT01242605|"     The objective of this study is to establish the recommended dose of selumetinib, a novel MEK     inhibitor for use in combination with gemcitabine and cisplatin.   "
155947|NCT01242592|"     The purpose of the study is to evaluate the effect of homeopathy as an adjuvant to Anti     tuberculosis treatment on sputum conversion, hematological, clinical sign and symptoms of     relapsed Pulmonary TB.   "
179016|NCT00189722|"     This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.   "
155949|NCT01242566|"     The management of glioblastoma in elderly patients with poor performance status (KPS<70) is     unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and     safety of temozolomide alone in this population   "
155950|NCT01242553|"     To demonstrate clinical substantial equivalence of iVue as comparable to commercially     available RTVue.   "
155951|NCT01242540|"     Blood oxygen level dependant (BOLD) functional magnetic resonance imaging (FMRI)     investigations of pain have provided substantial insight into the workings of the human     brain. To date, however, the vast majority of studies have dealt with short painful     stimulations. This work will expand the investigators knowledge of how longer stimulations     are processed by comparing the activation pattern from a two minute painful stimulation with     that of an 30-second painful stimulus. The investigators hypothesis that accommodation to the     longer stimulation will be evident by either decreases in signal intensity in brain areas     known to process pain, or by increasing activity in brain areas thought to be responsible for     the modulation of painful perception.   "
155956|NCT01242475|"     A new, more specific skin test to detect tuberculosis has been developed by Statens Serum     Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a     positive test result will show as redness and/or swelling at the injection site, while a     negative test will leave no reactions.      The aim of this study is to test the C-Tb skin test in healthy adults previously BCG     vaccinated to determine if healthy non tuberculosis infected individuals has a truly negative     test result (this is called determining the specificity of the skin test). To be able to     compare the new skin test with the current Tuberculin skin test volunteers will be injected     with both the C-Tb and the TST skin test.   "
155957|NCT01242462|"     Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm     infants. Despite improved survival of extremely premature infants with RDS, complications     related to mechanical ventilation still occur. This trial will attempt to maintain adequate     gas exchange at a rapid rate, short inspiratory time, low tidal volume, and low peak     inspiratory pressure in infants with respiratory distress requiring mechanical ventilation. A     cross over design will be used to test the hypothesis whether mid-frequency ventilation in     preterm infants with RDS requiring mechanical ventilation will reduce the peak inspiratory     pressure requirement when compared to conventional mechanical ventilation.   "
155958|NCT01242449|"     This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks     intervals in combination with trastuzumab as 1st and 2nd line treatment of women with     metastatic HER2 positive breast cancer.      Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic     breast cancer, and capsules are generally better tolerated.   "
155959|NCT01242436|"     Ovarian cancer is a gynecological cancer with a high risk of mortality. This is because the     diagnosis is often been made in an advanced cancer stage with metastases throughout the     peritoneum.      An international study led by Prof. Dr. Ignace Vergote (Gynaecological Oncology) showed for     the first time that patients in such an advanced stage of ovarian cancer who received first     three neoadjuvant platinum-based chemotherapy regimens followed by interval debulking     surgery, and in turn followed by at least 3 treatment with platinum-based chemotherapy, had     fewer complications than patients treated with primary debulking surgery followed by     chemotherapy. Moreover, the final survival rate in both groups seemed to be similar. The most     important prognostic marker appeared to be whether patients with primary or interval surgery     no longer had a visible residual tumor after the treatment. Patients who had only small     metastases in the peritoneum, seemed to be better treated with primary surgery (neoadjuvant     Vergote I, et al Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Crystallising, N     Engl J Med 363 (1910): 943 - 953).      Each patient with suspected advanced ovarian cancer should undergo a preoperative evaluation     where they assess which of the two treatments is the best option.      The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI) as a     non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal     metastases. This is to assess which of the two treatments (primary debulking surgery followed     chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval debulking     surgery, followed in turn by chemotherapy) is the best option for a particular type of     patient.   "
155960|NCT01242423|"     The study is to review whether musculoskeletal shockwave therapy (ESWT) can speed up the     healing of second-degree burns as well as skin-graft donor sites.      In both cases, the primary hypothesis is the shortened period leading up to the complete     healing of the wound (reepithelization).      The secondary hypothesis in the course of the study assesses:      the rare manifestation of undesirable local events (e.g. reddening, swelling, hematoma).   "
155961|NCT01242410|"     Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in     pregnant women with twins and a short cervical length at 18-22 weeks scan.   "
155962|NCT01242397|"     The purpose of this study is to show that CRT(Cardiac Resynchronization Therapy) pacing in     patients with severe functional MR (Mitral Regurgitation) who are not currently indicated for     CRT will demonstrate chronic benefit of MR reduction( via echo measured MR/LA area and ERO     per American Society of ECHO guidelines) and to show that CRT pacing is safe in these     patients.   "
155963|NCT01242384|"     Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in     pregnant women with short cervical length after an episode of threatened preterm labour.   "
155964|NCT01242371|"     The investigators intend to explore the hypothesis that symptoms of schizophrenia may be     reduced by the administration of a probiotic supplement when used in addition to standard     antipsychotic medications.   "
155965|NCT01242358|"     In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may     occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an     additional capnographic monitoring is subject of the study.   "
155966|NCT01242345|"     In this randomized controlled trial the utility of capnography and IPI gets evaluated.     Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be     prevented by an additional capnographic monitoring is subject of the study.   "
155967|NCT01242332|"     To prove pregabalin's efficacy and safety in Thai patients scheduled for arthroscopic ACL     reconstruction   "
155968|NCT01242319|"     This quality improvement trial aims to evaluate whether giving patients information about     their coronary heart disease risk via a computer kiosk in the doctors waiting room and     providing primary care doctors with a personal digital device with a decision support tool to     help with cholesterol management will improve cholesterol management compared to usual care.   "
155969|NCT01242306|"     This is a prospective, randomised study to compare the endothelial dysfunction of BMS vs SES,     both implanted in the same patient with multiple de novo coronary artery lesions undergoing     elective PCI. The primary end point will be the evaluation of endothelial dysfunction at 6     months follow-up by measuring the change in vessel diameter in 5 points of the stent and     peri-stent site after infusion of acetylcholine.   "
155970|NCT01242293|"     The purpose of this study is to determine that maternal hydration during labor with fluids     containing glucose at a rate of 125 ml per hour does not affect the duration of labor     compared to Ringer Lactate at a rate of 250 ml per hour.   "
157271|NCT01225146|"     The RAVE 2 trial is a phase I, open label, 12-month trial of intravitreal ranibizumab 2.0 mg     in patients with ischemic CRVO who have been either previously treated with ranibizumab or     treatment naïve.   "
155971|NCT01242280|"     In the last years, important advances have been done in the treatment and prevention of     esophageal variceal bleeding. Experts agree that the combination of pharmacological and     endoscopic therapy should be the first line therapy in the acute bleeding episode; whereas     TIPS (transjugular intrahepatic portosystemic shunt) is considered a rescue therapy.     Nevertheless, some patients would require different therapies to act as a bridge until     definitive therapy can be instituted. Balloon tamponade (using the Sengstaken tube)     represents, up to now, the most widely used temporary bridge to TIPS. However, balloon     tamponade is associated with a high incidence of serious adverse events. Recently, the use of     self-expanding metal stents have been introduced in the treatment of acute variceal bleeding     showing a very high hemostatic efficacy with no adverse events. The present study is directed     to compare the efficacy free of adverse events and mortality of self-expanding metal stents     vs balloon tamponade in patients with variceal bleeding refractory to medical and endoscopic     therapy.   "
155972|NCT01242267|"     The primary objective of this study is to:      • Determine the maximum tolerated dose of thalidomide used in conjunction with dose-intense     melphalan, bortezomib and autologous (syngeneic) HSC support in the salvage therapy of     patients who failed a prior treatment with dose-intense melphalan      The secondary objectives of this study are to:        -  Determine the toxicities resulting from administration of combinations of thalidomide,          bortezomib and melphalan        -  Determine the complete response (CR) and very good partial response (VgPR) rate in          patients undergoing ASCT using thalidomide, bortezomib and melphalan        -  Evaluate the treatment-free interval after treatment with the combination of          thalidomide, bortezomib and melphalan   "
155973|NCT01242254|"     This study is designed to assess the efficacy and safety of multiple intravitreal injection     of KH902 in patients with CNV due to AMD.   "
155974|NCT01242241|"     Obesity in children,as in adults,has rapidly become a public health concern. Studies in     adults have shown that obesity, now considered to be a disease state, is a modifier of the     effect of drugs on the body as well as how the body handles the drug.The anesthetic     management of obese children poses a variety of significant challenges which include     determination of the appropriate dose of anesthetic intravenous agents. Dosing of most drugs     is calculated based on the effective dose in 50% of patients but the more practical and     required information is the effective dose in 95%(ED95%)of patients. The aim of this study is     to determine the effective dose in 95% of patients(children). The hypothesis is the ED95 of     propofol in obese children will be higher than that of non-obese children.   "
155975|NCT01242228|"     This study is to evaluate long-term safety and efficacy after concomitant administration of     ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.   "
155976|NCT01242215|"     This study is to evaluate the efficacy and safety after concomitant administration of ASP1941     and sulfonylurea in patients with diabetes mellitus.   "
155977|NCT01242202|"     This study is to evaluate long-term safety and efficacy after concomitant administration of     ASP1941 and α-glucosidase inhibitor in Japanese patients with type 2 diabetes mellitus.   "
155978|NCT01242176|"     The objective of the study is to investigate the relative bioavailability of the final tablet     formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).   "
155979|NCT01242163|"     Discriminating irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD),     especially with mild disease activity, is common clinical challenge. Most of the patients     with suspected IBS have to go invasive procedures (colonoscopy/gastroscopy). In order to     avoid invasive investigations, there is a search for noninvasive markers with the capacity to     distinguish between IBS and IBD. Dr Hossam Haick (Department of Chemical Engineering,     Technion) developed a system that combines nano-metals produced in his laboratory with     electrical devices (transistors). The combination between a nanomaterial and an electrical     transistor induces a change in its electrical behavior upon exposure to the material being     examined; that is, a change in its electrical properties. The change in its electrical     behavior is translated into a computerized graphic signal.      The electronic nose is composed of an air pump, a filter for filtering external contaminants     and an array of sensors. Each sensor transmits a signal according to the materials it knows     how to identify. Thus, it is possible to characterize most of the substance families     characteristic of a certain disease, and the same system is designed for differential     diagnosis of different diseases.      The purpose of the investigators study is to use the electronic nose to find bio-markers     that will help to diagnose IBD and IBS without using invasive procedures.      The plan is to collect 200 samples (50 IBS' 50 Crohn's disease, 50 ulcerative colitis and 50     controls). The patients included in the study will undergo an evaluation by a     gastroenterologist after signing an informed consent and will answer a questionnaire.      The samples will analyzed in the laboratory of Dr. Haick.   "
155980|NCT01242150|"     In critically ill pediatric patients with Acute Respiratory Failure (ARF), Noninvasive     Continuous Positive Airway Pressure (NCPAP) is applied to avoid intubation and all related     complications such as tracheal injury and predisposition to nosocomial pulmonary infections.     The choice of the interface is one of the crucial issues affecting treatment outcome in     pediatric age and in particular in preschool children in whom intolerance frequently     compromise noninvasive respiratory treatment. NCPAP is applied either through nasal or facial     tight fitting masks and the most important principle in guiding the selection of an interface     is that it should fit comfortably. However, while nasal mask can leak gas when the infant     opens his/her mouth, facial mask can cause significant gastric distension and vomiting, with     risk of aspirating gastric contents. Moreover, complications such as air leaks, skin     irritation on the bridge of the nose, and discomfort reported with nasal or facial masks in     children frequently lead to interruption of the respiratory treatment. Thus, improving the     interface between the patient and the ventilator would be expected to facilitate longer and     more effective application of NCPAP.      A new small helmet specifically designed for young infants has been recently introduced to     administer NCPAP. In a recent short term crossover physiological randomized controlled trial,     the investigators found that NCPAP by helmet was associated with enhanced feasibility, less     need of sedation and prolonged application time (see references below). The purpose of this     prospective randomized multicenter study is to compare the efficacy and feasibility of NCPAP     delivered either by helmet or by facial mask to treat acute respiratory failure in infants     admitted to Pediatric Intensive Care Unit (PICU).   "
155981|NCT01242137|"     Glibenclamide is metabolized by the hepatic enzyme P450 CYP2C9 to less active form.     Polymorphism of this enzyme demonstrated clinical significance when examined on other drugs     from the sulfonylurea drug family, to whom Glibenclamide is included.      The investigators assumption is that patients with less active alleles of the enzyme may show     lower dose requirements of the drug for glycemic control, when compared to patients     homozygotes to wild-type alleles.   "
155982|NCT01242124|"     The purpose of this study is to determine the safety and efficacy of the side-to-side stapled     intrathoracic esophagogastric anastomosis in Ivor-Lewis Oesophagectomy.   "
155983|NCT01242111|"     This multicenter, open-label extension study is designed to assess long-term efficacy and     safety of 2.0 milligrams (mg)/kilogram(kg)/week of BMN 110 in patients diagnosed with     Mucopolysaccharidosis IVA (MPS IVA). Patients with MPS IVA, who enrolled in a prior BioMarin     sponsored clinical study of BMN 110 (NCT00884949; Study Identification Number MOR-002), were     eligible to enroll in this study (except patients who enrolled in NCT01275066; Study     Identification Number MOR-004).   "
155984|NCT01242098|"     The purpose of this study is to evaluate whether beclomethasone dipropionate / formoterol     (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to     fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients     switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared     with patients not switched.   "
155985|NCT01242085|"     The hypothesis of this study is that total knee alignment will be improved by preoperative     planning from CT scans and the production of custom instruments compared to the use of     standard instruments.   "
155986|NCT01242072|"     This an an open-label study to define the safety profile and the maximum tolerated dose and     confirm the clinical effective dose of palifosfamide-tris given intravenously in combination     with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are     normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study     using the 3 agents combined will begin.   "
155987|NCT01242059|"     It is hypothesized that yellow pea protein and fiber will reduce short-term food intake,     subjective appetite and glycemic response.   "
155988|NCT01242046|"     The key research question in this study is whether or not caffeine facilitates genital sexual     arousal in women in the presence of an external erotic stimulus. Caffeine's impact on the     human sexual response cycle has yet to be studied in the field, so the goal is to determine     if this substance will have any impact on genital arousal well as potentially identify the     mechanisms underlying its ability to do so. Considering that this will be a single blind     study, a key goal of the project is to determine how participant expectations regarding what     they ingest will impact their subjective sexual arousal. At present, we hypothesize that, as     caffeine's stimulant properties increase a human's heart rate and blood pressure, caffeine     intake will facilitate genital arousal.   "
155989|NCT01242033|"     Eight healthy adult subjects will be given a meal of one, two or four cups red raspberries,     or two slices white bread with or without 200 mg vitamin C, after an overnight fast and     consumption of a low polyphenol diet for two days. Blood samples will be taken at various     time points over an eight hour period to measure oxidative stress and antioxidant levels in     the blood. Each subject will attend 5 study visits with one week intervals and be given each     meal in a random order. It is hypothesized that raspberry consumption at higher doses will     greater protect against meal-induced oxidative stress compared to bread controls.   "
155990|NCT01242020|"     The purpose of this study is to test a method of imaging (taking a picture) of the abdomen     (belly), neck, thigh and calf (lower leg) areas of the body, using ultrasound along with a     drug which makes the pictures look clearer. Ultrasound is a type of imaging that uses sound     waves to create a picture of the inside of the human body. Two sets of pictures will be taken     on two different days to see if the results are the same each time.      DEFINITY® is a drug given intravenously (through the vein). DEFINITY® is approved by the FDA     to be used as an ultrasound contrast agent (makes the pictures look clearer) while taking     pictures of the heart. In this study, DEFINITY® will be used while taking pictures of blood     vessels in your abdomen (belly), neck, thigh and calf (lower leg). Since this use of     DEFINITY® is different than the use approved by the FDA, this study will be performed under     an FDA Investigational New Drug (IND) application.   "
156002|NCT01241864|"     The purpose of this study is to learn about the safety of islet transplantation when     performed after kidney transplantation, which may provide more normal control of blood sugar     without the need for insulin shots. Islets are special clusters of cells within the pancreas     that produce insulin. These cells will be obtained from cadaver (non-living) donors and given     to subjects by vein.   "
156003|NCT01241851|"     To determine whether acute aerobic exercise versus resistance exercise effects cognitive     function among older adults.   "
155991|NCT01242007|"     Myotonic dystrophy Type 1 (MD1, Steinert's disease), an autosomal dominant multisystem     disease, is of the most common muscular dystrophies in adults, with a European prevalence of     3-15/100 000. The disease course is progressive, associating muscular weakness, wasting and     myotonia. Respiratory dysfunction is common, involving a restrictive ventilatory abnormality     and alveolar hypoventilation, originating from respiratory muscle weakness. Depending on the     degree of impairment of their lung function, the quality of life and the prognosis of MD1     patients may be very variable. However, time course and prevalence of such respiratory     function impairment have not been clearly identified. More importantly, factors able to     predict poor respiratory outcome have not been defined and therefore early prognosis can not     be assessed during the follow-up of these patients. In other neuromuscular disorders,     especially Amyotrophic Lateral Sclerosis (ALS), postural spirometry has been recommended to     improve the detection of diaphragmatic involvement and some authors have suggested that the     supine fall in the forced vital capacity could be used to initiate noninvasive positive     pressure ventilation and predicts some respiratory symptoms.      In a sample of ambulatory patients with MD1, our study was designed to prospectively achieve     two aims: 1) to assess the respective prevalence of a ventilatory restrictive pattern,     respiratory muscle weakness, hypoxemia and hypercapnia and 2) to evaluate whether postural     changes in lung volumes contribute to sensitize the diagnosis of respiratory weakness and     could be used as a predictor of poor respiratory function, including hypoxemia, hypercapnia     and restrictive ventilatory disease.   "
155992|NCT01241994|"     AASD is a new dialysis technique based on the use of a mathematical model of intradialytic     solutes and fluid kinetic, for the automatic elaboration of dialysate sodium and     ultrafiltration rate profile. The aim of dialysate sodium and ultrafiltration rate profile is     to obtain the higher stabilization of intradialytic extra cellular compartment, in     consideration of end session targets: body weight and final patient's natremia. In this     multicenter prospective controlled randomized trial the primary end-point is the clinical     efficiency validation of AASD on intradialytic hypotension but also on thirst, cramps,     headache, nausea, vomiting, hypotensive events observed in basal treatment (HD or HDF).   "
155993|NCT01241981|"     This study will examine a new imaging technique called digital breast tomosynthesis (DBT)     compared to standard mammography in women under 60 presenting with signs of breast cancer.     The reason that we need to do this study is that standard mammography fails to detect the     cancer in approximately 20% of these women because younger women have denser breast tissue.     We hope that DBT will be more sensitive in detecting breast cancer than standard mammography.   "
155994|NCT01241968|"     Low intensity shockwaves have been proven in animal studies to induce local growth of new     blood vessels from existing ones.      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients     with refractory angina not amenable to revascularization with angioplasty or bypass surgery.   "
155995|NCT01241955|"     To compare the decision making of family members of patients admitted to the ICU in regards     to their CPR preferences for their loved ones with and without the use of a video decision     aid.   "
155996|NCT01241942|"     The purpose of this research study is to perfect the technique of EVLP and learn about the     safety of transplanting lungs that have been ventilated (attached to a breathing machine or     ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™,     made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in     a modified cardiopulmonary bypass circuit (the kind of device used routinely during most     heart surgeries). The purpose of performing ex-vivo lung perfusion and ventilation (EVLP) is     to learn how well the lungs work, and whether they are likely safe to transplant.   "
155997|NCT01241929|"     To compare the decision making of subjects with advanced cancer having a verbal advance care     planning discussion compared to subjects using a video.   "
155998|NCT01241916|"     Primary Question: When splinting is used to improve motion in post-traumatic stiff elbows,     is there a significant difference in gains in motion achieved between static progressive or     dynamic splint approaches?      Secondary Question: Is there a significant difference in patient compliance with static     progressive versus dynamic splint use, and does this effect final ulnohumeral motion     outcomes?   "
155999|NCT01241903|"     The central hypothesis for this work is that platelet - leukocyte interactions play a     critical role in the pathogenesis of acute ischemic events. The primary objective of the     study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor     rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention     exerts beneficial vascular effects by reducing platelet - leukocyte interactions.   "
156000|NCT01241890|"     Pulmonary exacerbations of CF are an important cause for the experienced disability of     patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic     therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is     important. The aim of this study was to assess the predictive properties of inflammatory     markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the     reliability of home monitor assessments of symptoms and lungfunction was investigated.   "
156001|NCT01241877|"     Background of the study:      Astaxanthin has been shown to be a powerfull anti-oxidant. Health benefits have been shown in     animals and humans. Exercise enhancing effects have been shown in animals via enhancement of     fat oxidation. We want to examine the effects of 4 weeks of astaxanthin supplementation on     fat oxidation and cycling performance in trained cyclists      Objective of the study:      To test the hypothesis that 4 weeks supplementation with astaxanthin will improve fat     oxidation and improve exercise performance in trained cyclists      Study design:      Double blind, placebo controlled study.      Study population:      Well trained cyclists between 18-30 years old      Intervention (if applicable):      astaxanthin (20 mg/day) or placebo for 4 weeks      Primary study parameters/outcome of the study:      performance on a time trial after 90 min steady state exercise.      Secundary study parameters/outcome of the study (if applicable):      substrate use plasma glucose plasma lactate plasma free fatty acid plasma astaxanthin      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness (if applicable):      The risks involved in participating in this experiment are minimal. Astaxanthin has been     shown to be safe. Insertion of the catheters in a vein is comparable to a normal blood draw     and the only risk is of a small local haematoma.   "
156004|NCT01241838|"     The purpose of this study is to compare the effect of heart rate on cardiac index in patients     with or without left ventricular hypertrophy. The study will be conducted in postoperative     heart surgery patients with a pacemaker.   "
156005|NCT01241825|"     The purpose of this study is to see if chewing sugarless chewing gum alters the time it takes     for a capsule endoscopy to travel through the stomach and small bowel, and to see if     more/less capsule endoscopes reach the large bowel.   "
156006|NCT01241812|"     High joint load during walking has been linked to cartilage degradation. Biomarkers, found in     the blood and urine, are protein fragments released after cartilage degradation     characteristic of OA. They have the potential to enable direct and immediate disease state     monitoring and identification of early cartilage changes. Little is known about the     association of biomarkers with joint load or if exercise aimed at reducing joint load changes     biomarker levels, thus reducing the risk of OA progression. This study will provide novel     information on these relationships and will guide future intervention studies. The     investigators hypothesize that certain biomarkers will be highly correlated with joint     loading during walking and that the levels of these biomarkers in the blood and urine will     decrease following an exercise intervention aimed at cartilage unloading.   "
156007|NCT01241799|"     Purpose:      To compare the diagnostic yield of endoscopic ultrasound guided fine needle aspiration biopsy     (EUS-FNA) in patient with pancreatic masses with and without the use of a stylet in place     within the biopsy needle.      Hypothesis:      In patients undergoing an EUS FNA for pancreatic indications, patients having a fine needle     aspiration biopsy (FNA) without the internal stylet will have a greater diagnostic yield     compared to those with the internal stylet.      Justification:      EUS-FNA is an increasingly important means of obtaining tissue samples from lesions within     the thorax and abdomen. In experienced hands EUS-FNA is a safe alternative to more invasive     procedures such as mediastinoscopy or laparoscopy. EUS-FNA can be used for sampling suspected     cholangiocarcinoma, pancreatic masses or cysts, submucosal gastric lesions, peripancreatic,     perigastric or mediastinal lymph nodes and in some cases adrenal or liver masses. Therefore,     it is a powerful tool for both diagnosis and tumour staging. For example, for the diagnosis     of pancreatic adenocarcinoma, which is a common indication for EUS-FNA, the sensitivity     varies from 75 to >90%, with a specificity of 82-100% and a mean accuracy of 85%. Improving     the diagnostic yield may lead to an earlier diagnosis with a reduced number of investigations     and earlier institution of treatment for the patient.      The FNA needle system consists of a 22 or 19 gauge needle which is manipulated by a handle     piston that attaches to the biopsy channel of the endoscopic ultrasound (EUS) linear scope.     The tip of the needle has grooves to disperse ultrasound waves making the tip of the needle     easily seen. The sample is taken by inserting a specially designed needle into the area of     interest under EUS guidance. Inside the needle is a removable stylet with a rounded or     bevelled tip to facilitate the passage of the needle into the tissue. The usual practice is     for the stylet to be extracted after the needle has been passed into its optimum position     within the tissue and for it to be re-inserted before each pass. However, a recent     prospective trial with 111 patients, published in abstract form, found this approach was     associated with a significant reduction in the proportion of adequate samples compared to     when the stylet was removed before passing the needle. Although there was no significant     difference in the diagnostic yield between the two groups this study raises the issue that     the stylet left in place is to the detriment of the tissue sample and, ultimately, may reduce     the diagnostic yield or increase the number of passes needed to obtain a satisfactory sample.      One limitation to this study includes the heterogenous patient population. Yields of EUS-FNA     vary considerably depending on the type of tissue being biopsied. The second limitation is     that consecutive patients were randomized to having the stylet removed versus having the     stylet not removed at the time of FNA. There is no control group from which to compare the     two groups. An improvement in the study design would be to have each patient to be their own     control group. Successive passes of the FNA needle can increase the bloodiness of the sample,     so randomization of the order in which each group is done will help eliminate potential bias.      It is clear from the current published literature that removing the stylet increases the     cellularity of the sample. However, this increased cellularity may be the result of more     contamination from the GI tract through which the FNA needle needs to pass in order to get an     extra-luminal sample. Blood or a traumatic FNA can also lead to increased cellularity that     can compromise diagnostic accuracy.      Diagnostic yield depends on both adequacy of the sample and enough cells from the lesion to     interpret. A preliminary result based on an air dried slide often can lead to fewer FNA     passes if a diagnosis can be made. If this is not possible, a cell block preparation is made     from all the washings from the EUS-FNA needle. No study has examined the diagnostic accuracy     of these two types of samples using an EUS-FNA needle with and without the stylet within the     same patient.      Objectives:      To determine if the diagnostic yield of EUS-FNA is increased if the stylet is removed from     the FNA needle compared with leaving it in place.   "
156008|NCT01241786|"     To determine the response to the combination of azacitidine + lenalidomide in patients with     relapsed/refractory CLL and SLL      Hypothesize - lenalidomide's activity in combination with azacitidine may further enhance its     activity and the durability of treatment response.   "
156009|NCT01241773|"     The purpose of this study is to investigate the effect of steady-state concentrations of     TMC435 on the steady-state pharmacokinetics of efavirenz or raltegravir , and vice versa.     Steady state is a term which means that the drug has been given long enough so that the     plasma concentrations will remain the same with each subsequent dose. TMC435 is being     investigated for the treatment of chronic hepatitis C virus (HCV) infection. Efavirenz and     raltegravir are two antiretroviral drugs for treatment of human deficiency virus (HIV)     infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream,     distributed in the body and eliminated from the body.   "
156010|NCT01241760|"     The purpose of this study is to evaluate the effectiveness of telaprevir administered twice     daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in     treatment-naïve participants with chronic HCV genotype 1 infection.   "
156011|NCT01241747|"     Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in     exercise performance, peripheral vascular function, and health-related quality of life than     compared to the attention-control group.      Hypothesis #2. The change in peripheral vascular function will be predictive of improved     exercise performance following the supervised exercise program.   "
156012|NCT01241734|"     The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the     patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the     RICE therapy and again after transplant as maintenance. To improve over all outcome and     survival.      Hypothesis is that combining lenalidomide with standard of care (RICE) may increase overall     response rate thus increasing the number of patients able to proceed with autologous stem     cell transplant. This in turn may translate into improved overall survival and progression     free survival.   "
156013|NCT01241721|"     The purpose of the study is to determine the optimal, lowest dose of radioactive tracer     required for Positron Emission Mammography (PEM), and the accuracy and reliability of PEM in     pre-surgical evaluations for patients with newly diagnosed breast cancer anticipating     breast-conserving surgery but identified to have a second unsuspected breast cancer by MRI.   "
156014|NCT01241708|"     High dose chemotherapy with stem cell transplantation is commonplace in the treatment of     multiple myeloma. This treatment uses a chemotherapy drug called Melphalan that has been used     in several thousand bone marrow transplant recipients worldwide for the same or similar     disorders.   "
156015|NCT01241695|"     The purpose of the study is to determine the safety, acceptability and the efficacy of a     12-week intervention with a diabetes-specific oral nutritional supplement on glycaemic     control in type 2 diabetic patients with or at risk of malnutrition   "
156016|NCT01241682|"     Earlier the investigators determined the safety and feasibility of tumor lysate-pulsed     dendritic cells as therapeutic adjuvants in mesothelioma patients. Because pre-clinical data     in mice had shown that better results were obtained when regulatory T cells were depleted     using low-dosis of cyclophosphamide, ten patients who responded on chemotherapy are selected     for DC-treatment in combination with Endoxan.   "
156017|NCT01241669|"     This is a drug-drug interaction study to evaluate the effects of steady-state exposure of     E5555 and its main metabolites on the pharmacokinetics (PK) of metformin, an organic cation     transporter-2 (OCT2) substrate. In addition, the study will also investigate the effects of     E5555 on several renal function parameters.   "
156018|NCT01241656|"     In this study we will compare 3 strategies for systematic delivery of prostate cancer     screening decision support interventions (DESI) to usual care and examine their impact on     screening decisions and subsequent healthcare utilization using a randomized control design.      We hypothesize men who are given the opportunity to review a DESI by one of the 3 strategies     will be less likely to opt for prostate cancer screening, and will have lower subsequent     healthcare utilization than men in the control group.   "
156019|NCT01241643|"     This is a Phase II multicenter, open-labeled, controlled, randomized study assessing weekly     doses of Interleukin-7 (CYT107)   "
156020|NCT01241630|"     Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder     dysfunction. Recently, the concept of a surgically created somat-sensory reflex arch for     bladder dysfunction in SCI has been introduced. The concept is promising, not just for     bladder but also for bowel dysfunction. However, well designed studies need to be performed     before recommending the procedure to a large number of patients worldwide. In this study we     perform multidisciplinary studies providing necessary information about the clinical outcome     of the somato-sensory reflex arch in adult SCI patients.      The hypothesis is as follows:        1. In a western setting the somato-sensory reflex arch can be created in adult SCI          patients with only minor morbidity and complications.        2. Somato-sensory reflex arch reduces bladder and bowel symptoms in SCI patients.   "
156021|NCT01241617|"     The objective of this study is to confirm superiority between a test treatment group using     Endo GIA stapler with Duet Tissue Reinforcement System (TRS) and a current international     standard of care group using a conventional stapler in patients undergoing pulmonary     lobectomy surgery, using a randomized comparative study of the frequency of intraoperative     air leak.   "
156022|NCT01241591|"     To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550     for treatment of moderate to severe chronic plaque psoriasis.   "
156023|NCT01241578|"     Standard behavioral treatment (SBT) for obesity is often effective, but weight losses are     highly variable, and patients sometimes fail to achieve a successful weight loss of 5-10%     of their starting weight. It has been suggested that the one size fits all approach of SBT     may be responsible for many treatment failures because the intervention is not sufficiently     tailored to address the unique needs of each patient. Moreover, treatment is delivered in the     clinic, not in the settings and the times when it is needed most. The primary aim of the     proposed research is to develop and pilot test a behavioral weight loss intervention that     combines in-person sessions with treatment delivered via an electronic handheld device to     provide highly individualized weight loss treatment in patients' natural environment. In a     critical departure from previous research using cell phone technology, the portion of     intervention that is delivered via handheld device will be of equal sophistication and     importance to the portion of the intervention that is delivered in face-to-face treatment     sessions. The proposed study seeks to determine the feasibility and preliminary efficacy of     an individually tailored behavioral weight loss program that integrates clinic-based care and     smartphone technology.   "
156024|NCT01241565|"     The objectives of this clinical trial are to compare the incidence and duration of air leaks     and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic     Surgery) when using the ENDO GIA™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in     a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).   "
156025|NCT01241552|"     This study will investigate whether: 1) treatment with MK-3415A in addition to standard of     care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence     as compared to treatment with MK-6072 or MK-3415, 2) treatment with MK-3415A, MK-6072, or     MK-3415, in addition to SOC antibiotic therapy will decrease CDI recurrence as compared to     placebo, and 3) MK-3415A, MK-6072, and MK-3415 will be generally well tolerated in     participants receiving SOC therapy for CDI as compared to placebo.   "
156026|NCT01241539|"     The current study will allow the assessment of pharmacokinetics, pharmacodynamics,     elimination rate and clearance of dabigatran etexilate during and following haemodialysis in     ESRD patients.   "
156027|NCT01241526|"     The goal of the study is to evaluate a Home-Based Disease Management program specifically     developed for patients with Gold III/IV COPD.      By improving disease knowledge, awareness of significant clinical deterioration and     self-management skills for patients, this Home-Based COPD Management Program is expected to     reduce the severity of exacerbations, the need for emergency hospitalisations, thus     demonstrating the efficacy and the cost effectiveness of this intervention.   "
156028|NCT01241513|"     The main purpose of this study is to determine if a drug (acetyl-cysteine or ACCY) can     increase the amount of oxygen in your body at a high altitude of 11,500 feet. ACCY is     approved by the Food and Drug Administration (FDA) as a treatment or antidote for Tylenol     overdoses. Other forms of ACCY are also sold over-the-counter as nutritional supplements. In     this study, the FDA-approved form of ACCY will be used off-label (meaning in a way not     approved by the FDA).      This study is being conducted by researchers from the United States Army Research Institute     of Environmental Medicine (USARIEM). The study will take place in the Altitude Chamber     located in the basement of USARIEM. A total of approximately 30 volunteers (men and women,     military and civilians) will take part in the study. They can expect to be in the study for a     minimum of a few hours each day for two weeks.      The investigators hypothesize that ACCY will improve ventilation and oxygenation while at     altitude.   "
156029|NCT01241500|"     The primary objective of this study is to compare overall survival (OS) in patients receiving     ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of     patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow     blasts) who have failed azacitidine or decitabine treatment. This patient population has no     available therapy and a short life expectancy (approximately 4 months). The high level of     bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to     delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant     and severe complication, which shortens survival of these MDS patients.   "
156030|NCT01241487|"     This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in     hypertensive patients uncontrolled by monotherapy.   "
156031|NCT01241474|"     The purpose of this study is to determine whether a prolonged (9 month) high (6g/d) of marine     oil improves insulin sensitivity and glucose control in subjects with impaired glucose     regulation.   "
156032|NCT01241461|"     The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese     patients with advanced and/or metastatic solid tumors for which no proven effective therapy     exists.   "
156033|NCT01241448|"     LY2409021 is being evaluated for possible treatment in type 2 diabetes. This study is     designed to compare LY2409021 given alone or given in combination with metformin against     placebo the change in hemoglobin A1c after a 24-week treatment period.   "
156034|NCT01241435|"     The purpose of this study is to evaluate the effect of liver function on how much of the     study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid     of it. Information about any side effects that may occur will also be collected.      The duration of participation in this study is approximately 12 days not including the     screening visit. This study requires 1 clinic confinement of 5 days/4 nights followed by 1     outpatient follow-up visit. A screening visit is required within 30 days prior to the start     of the study. This research study will be an open label study.      The study involves a single oral dose of 18 mg LY2216684 given as 2 tablets.   "
156035|NCT01241422|"     The purpose of this study is to evaluate the allergen-induced late asthmatic response (LAR),     as measured by maximal percent fall in forced expiratory volume in 1 second, in participants     with stable mild atopic asthma after treatment with JNJ 40929837 as compared to placebo.   "
156036|NCT01241409|"     The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2     sprinkle capsule formulations of rabeprazole sodium when administered without food to healthy     volunteers. In addition, the pharmacokinetics of 1 formulation of rabeprazole sodium will be     evaluated when administered with food to healthy volunteers.   "
156037|NCT01241396|"     The primary objective of this observational study is to document and describe current     treatment regimens and disease progression of patients with Multiple Myeloma (MMY). The aim     of this registry is to provide accurate, descriptive information on the way Multiple Myeloma     is treated in routine clinical practice. The registry will collect information related to the     treatment received for Multiple Myeloma. About 3000 patients will take part in the study in     about 28 countries. The registry will only collect information that is already in medical     files regarding treatment. Patients will not be required to actively do anything in addition     to what would be done without participating in this registry, nor will there be any     procedures or interventions that are not already part of the current treatment.   "
156059|NCT01241110|"     Objective: To compare two oral treatments: Ofloxacin + Metronidazole, and Azitromycin     +Metronidazole in outpatients with Pelvic Inflammatory Disease.      Materials and Methods: Two hundred patients divided to two groups( A , B). Group A (treated     by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine     1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy   "
157272|NCT01225133|"     The aim of this study is to evaluate the effectiveness of a complex āyurvedic diagnosis and     treatment compared to conventional standard care in patients with OA of the knee.   "
156038|NCT01241383|"     Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen     deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular     phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of     patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting     enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of     the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic     improvement, SRC remains a severe manifestation of SSc and functional outcome and survival     remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist that     has recently been approved for the treatment of primary pulmonary arterial hypertension and     for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits on     others vascular injuries and particularly in SRC.   "
156039|NCT01241370|"     The purpose of this study is to investigate microvascular endothelial function in the retina     of lean, obese, and type 2 diabetic subjects and to compare microvascular endothelial     function in the retina with several other established markers of endothelial and     microvascular function.   "
156040|NCT01241357|"     The proposed research project will continue the application and development of a new method     (biomagnetic susceptometry) that measures magnetic fields to determine how much iron is in     the liver. The amount of iron in the liver is the best indicator of the amount of iron in the     whole body. Measuring the amount of iron in the body is important because either too much     (iron overload) or too little iron (iron deficiency) can be harmful. At present, the most     reliable way to measure the amount of iron in the liver is to remove a sample of the liver by     biopsy, either by surgery or by using a needle which pierces the skin and liver. Iron stored     in the liver can be magnetized to a small degree when placed in a magnetic field. In patients     with iron overload, the investigators previous studies have shown that magnetic measurements     of liver iron in patients with iron overload are quantitatively equivalent to biochemical     determinations on tissue obtained by biopsy. In the past the investigators have developed a     device to measure the amount of magnetization, which was called a SQUID (Superconducting     QUantum Interference Device) susceptometer. This device was validated and in use for over 20     years. The safety, ease, rapidity and comfort of magnetic measurements make frequent, serial     studies technically feasible and practically acceptable to patients. The investigators have     now developed a new susceptometer, which uses very similar technology to the SQUID, but the     investigators believe is more accurate and precise. This study aims to validate this new     instrument. The investigators will do prospective, serial studies of the diagnosis and     management of patients with iron overload, including thalassemia major (Cooley's anemia),     sickle cell disease, aplastic anemia, myelodysplasia, hereditary hemochromatosis, and other     disorders. Funding Source - FDA OOPD.   "
156041|NCT01241344|"     The primary objective of this study is to evaluate the safety and efficacy of preemptive     treatment with CMX001 versus placebo for the prevention of AdV disease in recipients of HSCT     with asymptomatic AdV viremia.   "
156042|NCT01241331|"     The purpose of this study is to compare the safety and efficacy of formulation BLI1100 to its     vehicle in the treatment of moderate-severe acne vulgaris.   "
156043|NCT01241318|"     This will be a cluster-randomized controlled trial to assess whether washing the umbilical     cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when     compared to the current standard of care, dry cord care.   "
156044|NCT01241305|"     The purpose of this study is to identify genes that increase the risk of developing     vasculitis, a group of severe diseases that feature inflammation of blood vessels. Results of     these studies will provide vasculitis researchers with insight into the causes of these     diseases and generate new ideas for diagnostic tests and therapies, and will be of great     interest to the larger communities of researchers investigating vasculitis and other     autoimmune, inflammatory, and vascular diseases.   "
156045|NCT01241292|"     The purpose of this study is to assess the safety and tolerability of Elotuzumab when given     in combination with Lenalidomide and low-dose Dexamethasone in subjects with relapsed or     refractory multiple myeloma (MM) in Japan.   "
156046|NCT01241279|"     The objective of this study is to demonstrate the correlation of near vision and changes in     higher order aberrations following lens extraction and to characterize the defocus curves of     Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in     adults.   "
156047|NCT01241266|"     This will be a multicenter prospective observational study carried out in China. The     investigators will collect data in a pre-specified Case Report Form. Main data from each     patient will include demographics, endoscopy classification, and both endoscopy and     pharmacological treatments received by patients. Data from each patient will be prospectively     collected from the day the patient is diagnosed as peptic ulcer bleeding by endoscopy and     receives endoscopy treatment if the investigator thinks it is needed and up to 30 days     afterwards. The proportion of peptic ulcer bleeding patients who are at high risk is the     primary outcome variable. High risk is defined as the patients with endoscopy Forrest     classification Ia to IIb. The rate and type of endoscopic treatment, the rate of successful     endoscopy treatment, the re-bleeding rate and the endoscopic re-treatment rate in high risk     peptic ulcer bleeding patients will be collected. The surgery rate and mortality rate in high     risk and overall patient population will be calculated.   "
156085|NCT01240772|"     This multicentre RCT aims to compare two surgical treatments of haemorrhoidal disease:     doppler-guided arterial ligation with mucopexy (DGALM) and stapled haemorrhoidopexy according     to Longo (SH). The hypothesis of the trial is that the DGALM is at a lesser risk and is more     cost-effective than SH. With a large number of patients managed in more than 20 centres, we     aim to demonstrate that DGALM has a lower morbidity than SH when treating haemorrhoidal     disease. At a lower postoperative risk and a lower risk of sequelae, the DGALM would     demonstrate to be cost-effective for health care system and attractive for patients.   "
156048|NCT01241253|"     The study uses a randomized, placebo-controlled experimental design consisting of 4 different     test treatments matched on carbohydrate (CHO) content. The three beans are similar in their     CHO content amount for ½ cup at ~20 grams CHO. Each of the bean varieties will be served in a     ~½ cup serving size with ~ ½ cup of plain steamed white rice (30 grams CHO) for a total of 50     grams of CHO per meal for each of the three test treatments. The 4th placebo or control     treatment consists of ~ 7/8 cup of rice alone, an amount consistent with the CHO content of     the test meals. Most diabetic meal plans recommend no more than 45-60 grams of CHO per meal.     Fifty grams of CHO is a standard amount for glycemic response testing in general.      The investigators hypotheses were:        -  The test meals containing the three bean types in combination with white rice will          decrease the participants' glycemic response when eaten as part of a meal.        -  The reduction in post-prandial glycemia will not differ between bean types in the          elicited responses among individuals with type 2 diabetes.   "
156052|NCT01241201|"     Rationale: Enterotoxigenic Escherichia coli (ETEC) bacteria adhere to the mucosa of the     proximal intestines. There it produces an toxin which presents a local and relevant challenge     to the intestines. This is proposed to give an indication of general resistance and/or the     local resistance of the intestines. The sequel of events of mucosal inflammation will be     characterized in this study. In addition we will evaluate the effects of probiotics by     comparing the infection symptoms and by measuring faecal weight and mucus in faeces.      Objective: The main objective of this study is to investigate the effect of probiotics on the     sequels of ETEC administration as intestinal permeability, inflammation and clinical signs as     total faecal output, relative faecal dry weight and mucin excretion in faeces. In addition,     the sequels of the mucosal inflammation will be characterized and biomarkers will be     searched.   "
156053|NCT01241188|"     Tuberculosis (TB) continues to be the most important bacterial infection worldwide and     therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.      The new skin test is named C-Tb. Like the current Tuberculin Skin Test (TST), the C-Tb test     is injected just under the skin and will when positive show a redness and/or swelling at the     injection site while a negative test will leave no reactions.      The aim of this trial is to test the C-Tb skin test in adults diagnosed with TB to determine     if a TB infected individual has a truly positive test result (this is called to find the     sensitivity of the skin test).   "
156054|NCT01241175|"     The aim of this study is to assess the effect of preoperatively administered intra venous     magnesium sulfate in attenuating pressure response to laryngoscopy and endotracheal     intubation in adult patients scheduled for elective non ocular surgery   "
156055|NCT01241162|"     This treatment study for relapsed high-risk neuroblastoma, Ewings sarcoma, osteogenic     sarcoma, rhabdomyosarcoma or synovial sarcoma involves an autologous cancer testis (CT)     antigen specific dendritic cell (DC) vaccine preceded by decitabine as a demethylating     chemotherapy.   "
156056|NCT01241149|"     Gastroesophageal reflux disease (GERD) is a common ailment affecting a significant portion of     the US population. With the advent and increased use of esophageal impedance monitoring, both     acid and nonacid reflux disease can be better diagnosed and treated. Patients with severe     symptoms or symptoms refractory to medical management may be offered anti-reflux surgery for     optimal treatment. Though there are a handful of studies evaluating the efficacy of     anti-reflux surgery on those patients with acid or non-acid related reflux disease, the     comparison between acid and non-acid reflux disease following surgery is lacking. We propose     a prospective study comparing clinical outcomes from those patients with acid versus non-acid     reflux disease following anti-reflux surgery with the use of validated and disease specific     quality of life surveys.   "
156057|NCT01241136|"     Pilonidal disease, a chronic infection involving the skin and subcutaneous tissues along the     sacrococcygeal area (natal cleft) is a common disease affecting mostly young adult males who     make up the majority of our military workforce. Surgical treatment options for pilonidal     disease vary widely from the invasive (e.g. wide open excisions) to minimally invasive     procedures (e.g. removal of lined sinus tracts using minimal excisions) as well as other     popular treatments involving myocutaneous or skin flaps (Limberg flap and Z-plasty). All of     these surgical procedures are associated with varying degrees of early and late recurrence     rates; however, the current, more popular procedure for the treatment of pilonidal disease     involves wide open excisions.      A recent advancement in the minimally invasive surgical technique for pilonidal disease     involves the use of Keyes trephines (a 2-to-9 mm diameter biopsy instrument) to excise the     individual pits and to drain the cyst cavities. Although this procedure has been proven to be     effective against pilonidal disease with an overall low early recurrence rate, no clinical     trial has been performed to rate this procedure of minimal excisions against the current,     more common procedure of wide open excisions. A recent report has suggested that the     recurrence rate of pilonidal disease for minimal excisions may be comparable to that of wide     excisions. Furthermore, reports have also suggested that this minimally invasive procedure     can be performed with minimal (and possibly local) anesthesia, less post-operative pain     medication, and may involve a shorter convalescence time for patients.      In order to compare the early recurrence rates of pilonidal disease and overall patient     satisfaction between procedures involving minimal and wide open excisions, we propose to     perform a prospective, randomized clinical trial comparing these two surgical procedures.     Randomly assigned patients will undergo either 1) wide excisions of all pilonidal-diseased     tissue (e.g. pits, cavity, sinus tracts), including a surrounding rim of normal tissue and     left open to heal, or 2) minimal excisions of lined sinus tracts using varying sized     trephines. Overall patient satisfaction will be evaluated by the amount of analgesic used for     the procedure, the number of dressing changes, the length of convalescence, and overall     patient tolerance of the procedures, both intra- and post-operatively. In addition, varying     data points will be collected with the use of a quality of life survey and visual analog pain     scale to analyze overall patient satisfaction. Patients will be followed for a period of two     years following surgery to evaluate for early recurrence of their pilonidal disease.   "
156086|NCT01240759|"     The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered     with metformin in subjects with type 2 diabetes mellitus.   "
156105|NCT01240486|"     Your child is able to participate in this study, if your child's doctor is planning to start     your child on HAART (which is a combination of at least 3 anti HIV drugs). When your child is     treated with HAART, the way your child's body is able to fight infection may change. The     immune system is the body's defense against infection. Your child's immune system may respond     in a stronger way to some types of infections that your child may already have. This immune     response may cause your child to become sick and the condition is then called immune     reconstitution inflammatory syndrome or IRIS.   "
156058|NCT01241123|"     Fast-track or enhanced recovery programs, which are the new standardized accelerated     clinical pathways for post-operative care for colorectal surgeries, have three goals: to 1)     quicken the return of bowel function (as evidenced by passage of flatus and stool), 2)     decrease the length of hospital stays, and 3) decrease the rate of overall complications.     Aside from several components, or interventions that can vary from institution to     institution, these programs share three common modalities: early oral feeding, protocol pain     management regimens less dependent on opioid use, and early mobilization (i.e. ambulation).     Evidence-based practice has shown that the modalities individually contribute significantly     to the program goals except for post-operative ambulation, which has not been shown to     increase bowel function although it contributes to decreased pulmonary complications and     early discharge of patients. Still, surgeons continue to advocate for early ambulation to aid     in the return of bowel function despite the lack of clear evidence supporting this notion.      The investigators propose a randomized, prospective clinical trial exploring the impact that     post-operative ambulation has on the outcome of colorectal surgeries, particularly on the     return of bowel function and the length of hospital stay. With the use of pedometers to     measure physical activity, the investigators will subject patients to either the current     traditional post-operative care or one with an aggressive ambulation regimen. Through the use     of radiopaque markers, the investigators hope to correlate increased ambulation with     increased gastrointestinal motility function to prove the impact of early ambulation on     post-operative care.   "
168206|NCT00042666|"     This study will measure the effectiveness and any side effects of LY317615 in patients with     Diffuse large B-cell lymphoma (a sub-type of Non-Hodgkins Lymphoma).   "
156060|NCT01241097|"     -  To test the hypothesis that therapy with high dose statin provides endothelial superior          benefit to the same cholesterol lowering with low-dose statin combined with ezetimibe.        -  To test the hypothesis that therapy with high dose statin provides anti-inflammatory          effect than the same reduction of cholesterol with low dose of statin plus ezetimibe   "
156061|NCT01241084|"     Objective The aim of the trial is to evaluate the beneficial effects of the oral     administration of the probiotic L. Reuteri (Reuterin®) on the airways allergic inflammation     in children with mild to moderate persistent asthma.      Study design This is a randomized, double-blind, placebo controller trial. 50 children will     be enrolled (age range 6-14 years), affected by mild to moderate persistent asthma based on     the GINA Guidelines and allergic to acarus (Dermatophagoides farinae and D. pteronyssinus     ++/+++). At the enrollment period all children have to show asthmatic symptoms and to be     under antileukotrienes treatment (Montelukast 5mg/die) based on the GINA Guidelines. Any     inhaling corticosteroids therapies have to be stopped 8 weeks before the trial beginning.      Patients will be randomly divided into 2 treatment groups:      Group A: 25 patients will take antileukotrienes + L. reuteri drops (108 CFU = 5 drops daily).      Group B: 25 patients will take antileukotrienes + placebo. At the enrollment period (T0),     after the 1st and the 2nd month of supplementation (T1 and T2), and also 1 month after the     supplementation end (T3), all patients will be clinically evaluated through spirometry, FeNO     determination and exhale condensate analysis.      During the entire trial period the number of asthmatic exacerbations and the use of beta-2     antagonists will be monitored by a diary properly examined at T1, T2 and T3.      All children will be enrolled at the Asthma and Infant Respiratory Physiopathology unit     Michele Miraglia del Giudice of the F. Fede Pediatric Department.      The analysis of the inflammatory markers on the exhaled condensate will be performer at T1,     T2 and T3 in the Pharmacology unit of the Experimental Medicine Department.      During the trial it will be possible to administer only salbutamole MDI if it needed. If     patients will be administered with any systemic corticosteroids they will exit from the     trial.      At the enrolment period all patients will receive the completed information on the trial and     the informed consent will be properly signed.   "
156062|NCT01241071|"     The purpose of this study is to determine whether myofascial release techniques are effective     in the improvement of pain, disability and electromyography response of lumbar muscles in     patients with chronic low back pain.   "
156063|NCT01241058|"     A registry of pediatric patients (under 18 yrs of age) diagnosed with Crohn's disease was     created in Belgium. Over a 2 year period 257 patients are included. These patients will be     follow up prospectively during 5 years. Demographic data, family history, disease     presentation and disease course including medication are registered in CRF's.   "
156064|NCT01241045|"     To evaluate the impact of the vaginal Ph and acidification of vaginal misoprostol on its     efficacy in facilitating induction of midtrimester abortion.   "
156065|NCT01241032|"     This study is designed to to investigate the effects of alcohol on the pharmacokinetics of     Udenafil tablet in healthy male volunteers   "
156066|NCT01241019|"     The purpose of this study is to determine whether the administration of topiramate to     newborns with hypoxic-ischemic encephalopathy potentiates the neuroprotective effect of     treatment with hypothermia.   "
156067|NCT01241006|"     This study seeks to compare the effectiveness of a single dose of oral dexamethasone versus 5     days of oral prednisone in the treatment of mild to moderate asthma exacerbations to prevent     relapse with an unscheduled return visit to a health care provider for additional asthma     treatment within 14 days. The investigators hypothesize that the two treatments will be     equally effective in relapse prevention.   "
156068|NCT01240993|"     A formal randomized efficacy trial testing the Mothers and Toddlers' program, an     attachment-based parenting intervention for mothers enrolled in addiction treatment and     caring for young children.   "
156069|NCT01240980|"     The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose     control of BMS-903452 compared to placebo in healthy subjects & relative bioavailability of     the crystalline and amorphous forms of BMS-903452 [Panels 4,6,11 & 12(Part A)] ; and subjects     with type 2 Diabetes Mellitus (Part B). The study will also determine the amount of     BMS-903452 in the blood.   "
156070|NCT01240967|"     The purpose of this study is to compare the absorption and distribution of a single oral dose     of TC-5214 in subjects with renal impairment and with subjects with normal renal function.   "
156071|NCT01240954|"     The purpose of this study is to compare different up-dosing schedules with Osiris.   "
156072|NCT01240941|"     This is a phase II Trial of MK-2206 in combination with Endocrine Therapy in patients with     Hormone Receptor Breast Cancer. After the maximum tolerated dose is determined in the phase     1b trial (under a separate NCT number), efficacy will be evaluated among 17 patients.   "
156073|NCT01240928|"     This is a phase Ib trial that evaluates the safety and tolerability of MK-2206 given in     combination with exemestane +/- goserelin in pre- and post-menopausal patients with hormone     receptor-positive metastatic breast cancer.   "
156074|NCT01240915|"     MultiStem(r) is a new biological product, manufactured from human stem cells obtained from     adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells     are believed to reduce inflammation and regulate immune system function, protect damaged or     injured cells and tissue, promote formation of new blood vessels, and augment tissue repair     and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of     Graft versus Host Disease with almost complete reversal of gastrointestinal pathology     (similar to pathology that would be expected in Ulcerative Colitis). These data, together     with safety data generated in 2 other clinical trials, suggest that MultiStem has the     potential to be a new treatment option for patients with ulcerative colitis. This is the     first study of MultiStem in this patient population and will cautiously explore the     safety/toleration and potential benefit of this new treatment in patients with moderate to     severe disease.   "
156075|NCT01240902|"     The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve®     System in the treatment of symptomatic severe aortic stenosis in subjects who have a     predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.   "
156076|NCT01240889|"     This study will be a randomized, double blind, placebo-controlled, parallel group study and     will include subjects with ragweed-induced seasonal allergic rhinitis.   "
156077|NCT01240876|"     The primary objective of the study is to evaluate the safety and efficacy of CEP-37247     compared with placebo as assessed by the occurrence of adverse events, and the mean change in     average pain intensity (API) in the affected leg.   "
156078|NCT01240863|"     The primary objective of this study is to evaluate efficacy of hydrocodone extended-release     (ER) tablets compared with placebo in alleviating moderate to severe pain in patients with     osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at     week 12.   "
156079|NCT01240850|"     Chronic periaortitis is a clinico-pathological entity encompassing idiopathic retroperitoneal     fibrosis and perianeurysmal retroperitoneal fibrosis. The treatment of this disease is     generally based on the use of glucocorticoids, which are often effective. However, prolonged     steroid treatments are usually needed to achieve a sustained remission; additionally,     patients frequently develop disease relapses following treatment discontinuation, therefore     they may be exposed to high cumulative doses of glucocorticoids.      Preliminary data reported in the literature show that methotrexate may be effective in     combination with prednisone for retroperitoneal fibrosis. In addition, methotrexate is often     used as a steroid-sparing agent in different inflammatory diseases.      The aim of this study is to evaluate whether a treatment with low-dose prednisone plus     methotrexate is non-inferior to conventional dose-prednisone in achieving remission in     retroperitoneal fibrosis patients.   "
156080|NCT01240837|"     The purpose of this study is to determine by how much, the ingestion of palm sugar increases     blood glucose concentrations and what the corresponding glycaemic index is. The investigators     estimate that the glycaemic index will be 68 (equal to that of sucrose).   "
156081|NCT01240824|"     The purpose of this study is to evaluate whether a new potential treatment for non invasive     bladder cancer is safe and if it leads to side effects such as irregular heart rate,     agitation, or burning with urination. Patients who have early stage bladder cancer and will     be receiving BCG, a bladder cancer therapy as recommended by a doctor, will be asked to     participate in a study where they are given the standard BCG followed by the experimental     drug, aminophylline. Although we hope this medicine may one day prove to help bladder cancer     patients, at the current time we do not know if it has any benefits at all. We have data in     mice that suggest that aminophylline slows the growth of tumors when coupled with BCG.   "
156082|NCT01240811|"     This pilot study is being performed to investigate the influence that starting contraception     with an IUD has on the local immune cell populations and features, with a particular focus on     the cells and cell-surface features that are important in HIV transmission (CD4 cells and     CCR5 cell receptors).      Based on results from large epidemiologic studies there seems to be a consistent finding of     slightly increased HIV acquisition in women who use hormonal contraception. It is not clear     if this is due to a biological phenomenon or if it relates to a difference in sexual     behaviors/risks of women on hormonal contraceptives.      The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within     the upper and lower genital tract of women 2 months after placement of progestin-containing     intrauterine devices for contraception as compared with women not using hormonal     contraception.   "
156083|NCT01240798|"     People report feeling sad and low (depression) or worried (anxiety) appear more likely to     subsequently suffer a heart attack, or angina. However it is not known whether depression or     anxiety actually causes heart disease. If these mental health problems and heart disease were     cause and effect this has important implications for world health. Previous research on this     topic has had several limitations. First, most studies have studied heart disease as if it     were one thing. There is a need for studies which distinguish different types of heart     disease (e.g. different types of heart attack, angina) which may be linked to mental health     problems in different ways. Second, it is not clear whether symptoms of heart disease come     before the depression or anxiety or the other way round? Much of the available research     cannot look at this in detail because they rely on data from occasional snapshots of study     populations rather than a continuous record. The investigators propose to use the linkage of     the national registry of coronary events to general practice records in the GPRD, which will     allow us to address these limitations. The investigators research will help us understand     better whether mental health problems cause the onset of different types of coronary disease.   "
156084|NCT01240785|"     Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used     worldwide in the treatment of type 2 diabetes and also in a few studies on patients with     gestational diabetes. The investigators aim is to compare insulin and metformin in the     treatment of gestational diabetes. The investigators hypothesis is that there is no     difference between insulin and metformin treated mothers in the main outcome criteria (birth     weight, neonatal complications).   "
156144|NCT01239979|"     The investigators sought to assess whether plasma myeloperoxidase (MPO) levels differ among     patients with stable and unstable CAD patients and control subjects, and correlate with     inflammatory and clinical risk factors such as ox-LDL, NO,leptin, adiponectin, sPLA2,     Lp-PLA2, homocysteine and 3-nitrotyrosine in the patients.   "
156087|NCT01240746|"     The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the     licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1),     and the investigational TIV containing the alternate B (B2) strain in children.      Primary Objective:      To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011     TIV (containing the primary B strain) and investigational TIV (containing the alternate B     strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains     separately among children aged 6 months to less than 9 years of age      Secondary Objective:      To demonstrate superiority of antibody responses to each B strain in QIV compared with     antibody titers following vaccination with the TIV that does not contain the corresponding B     strain, as assessed by GMT ratios and seroconversion rates.      Observational Objective:      To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, as     assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days     post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and     adverse events of special interest and serious adverse events (SAEs) collected from Visit 1     to Visit 2.   "
156088|NCT01240720|"     The aim of this Study Protocol is to provide a basis for the clinical development of     131I-F16SIP as an anti-cancer therapeutic agent.      The study follows and is greatly motivated by the promising results of a Phase I/II study     with a similar investigational drug developed by our Company, 131I-L19SIP, in several Italian     centers.   "
156120|NCT01240291|"     The purpose of this trial is to investigate if pharmacologically safe dose intravenous     glutamine dipeptide supplementation to multiple trauma patients receiving enteral nutrition     is associated with improved clinical outcomes in terms of decreased organ dysfunction,     infectious complications, and other secondary outcomes   "
168283|NCT00043784|"     Patients experiencing a mild heart attack will receive one of two medications which thin the     blood to discern which is superior.   "
156089|NCT01240707|"     Fire smoke inhalation may contribute to intrabronchial inflammation, airway obstruction and     impaired gas exchange. In this study the investigators will examine if the scope of     inhalation injury can be assessed soon after hospital admission based on clinical markers,     biochemical markers, Peak Expiratory Flow (PEF), spirometry and bronchoscopy. At 6 months a     lung function test and metacholine test will be performed to examine whether patients have     developed increased bronchial hyperreactivity (asthma) or not after the initial fire smoke     exposure.   "
156090|NCT01240694|"     The primary objective of this study is to evaluate the long term safety and tolerability of     repeated administration of subcutaneous (sc) CEP 33457 for injection every 4 weeks over 72     weeks (18 doses) in patients with systemic lupus erythematosus (SLE) who have participated in     a previous Cephalon sponsored clinical study of CEP 33457, and completed at least visit 8     (week 24 of that study).   "
156091|NCT01240681|"     The objective of this pilot study is to determine the effectiveness of Fluorothymidine     Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent Magnetic Resonance     Imaging (BOLD MRI) in assessing tumour response to neoadjuvant chemotherapy (NA CT) in women     with locally advanced breast cancer.   "
156092|NCT01240668|"     The registry is a multi-center, prospective, observational study designed to collect data in     patients with euvolemic and hypervolemic hyponatremia in the hospital setting in the USA and     hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH) in     Europe; patients with hypovolemic hyponatremia will be excluded from the registry. The     registry is observational in design, and the registry will collect data on patients with a     serum sodium ≤130 mmol/L. Data from the patients' chart will be collected throughout the     duration of the hospital, from admission to discharge, and the data will be entered into the     case report form (CRF) or into an electronic data capture (EDC) system. These patients will     be entered into the registry over the duration of 18 months at community, tertiary, and     academic medical centers from diverse multiple regions of the USA and Europe.      A patient's treatment will be determined by their caregiver and not by this protocol. Thus,     the registry will provide a unique opportunity to evaluate how the patients are managed under     real-world management conditions.   "
156093|NCT01240655|"     This is a dose escalation study that will assess the safety and efficacy of LCL161 in     combination with weekly paclitaxel in adult patients with advanced solid tumors.   "
156094|NCT01240642|"     The purpose of this study is to determine the effect of the ASA404 infusion rate and     co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on     the pharamcokinetics (PK) of free and total ASA404.   "
156095|NCT01240629|"     This is a research study for advanced prostate cancer. An experimental drug called AN-152     (also known as AEZS-108) will be used. The purpose of this study is to test the safety,     tolerability and benefits of an experimental drug called AN-152.      The participants tumor will be tested for expression of this receptor (using an old biopsy).     If the participants cancer does not have this receptor, participants will not be eligible to     participant in this study.      AN-152 (AEZS-108) is administered intravenously (IV) over 2 hours and will be given at the     specified dose every 3 weeks. Premedication with dexamethasone 8mg is recommended.      Participants will continue treatment until death, disease progression, unacceptable toxicity,     participants refusal, treatment delay >3 weeks, or the completion of 6 cycles. Continuation     beyond 6 cycles is left at the discretion of the study doctor.      The study is planned to last 2 years. Up to 55 (up to 18 for the Phase I portion, up to 37     for the Phase II portion).   "
156096|NCT01240616|"     Background:      - A brain circuit called the default network is the brain circuit that is active when the     brain is at rest; that is, when individuals are not concentrating on specific tasks. Previous     research has shown that the default network functions differently in people with     schizophrenia and Alzheimer s disease, and may contribute to the problems with memory and     concentration that can affect people who have these conditions. Studies have also shown that     nicotine affects the default network, but more research is needed on the ways in which     nicotinic receptors may change activity in these regions and thereby affect individuals     ability to concentrate on specific tasks.      Objectives:      - To determine whether and how nicotine and mecamylamine, a drug that blocks nicotinic     receptors, affect the default network in nonsmokers in ways that improve thinking and     concentration.      Eligibility:        -  Healthy, right-handed volunteers between 21 and 50 years of age.        -  Volunteers must not have used any kind of tobacco product in the past 2 years.      Design:        -  This study involves an initial screening visit, a training visit, and three testing          visits.        -  Participants will be screened with a medical history and physical examination, as well          as blood and urine samples and questions about smoking history.        -  Participants will have an initial training session to practice the tasks that will be          done during magnetic resonance imaging scans at the testing visits. These tasks will          test participants concentration and memory.        -  Participants will have three test sessions with the following combinations of study          drugs: (1) a nicotine patch and a placebo capsule, (2) a placebo patch and a capsule of          mecamylamine, or (3) a placebo patch and capsule. Different combinations will be given          at each visit, and participants will not know which one they receive.        -  Participants will perform the same concentration and memory tasks at each testing visit,          and will provide a blood sample after each visit to determine levels of nicotine and          mecamylamine.   "
156170|NCT01239641|"     The purpose of this study is to determine whether HIFU has superiority over traditional     surgery on satisfaction and adverse impact.   "
156171|NCT01239628|"     The purpose of the protocol is to evaluate injection intervals and treatment modalities up to     3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb     spasticity after stroke.   "
156097|NCT01240603|"     Plasmodium falciparum parasite clearance rates (PCRs) after oral artesunate treatment of     patients with uncomplicated malaria were recently found to be significantly slower in Pailin     (Western Cambodia) compared to Wang Pha (Eastern Thailand). This difference in PCRs has been     attributed to different histories of artesunate drug pressure in the two areas. In Pailin,     artesunate monotherapy has been used inappropriately for 30 years and is hypothesized to have     selected for artemisinin-resistant parasites (slow PCRs). To investigate the potential     contribution of human factors to the artemisinin resistance phenotype, we have identified a     study site in Eastern Cambodia where artemisinin-resistant parasites are not believed to be     present. The main aims of this study are to 1) determine whether the artemisinin resistance     phenotype (i.e., a half-life longer than the 2-hour half-life observed in Wang Pha) is     present in Eastern Cambodia, 2) determine whether hemoglobin E affects parasite clearance     rates in vivo, 3) determine whether age-associated acquired immunity affects parasite     clearance rates in vivo, and 4) identify parasite-heritable traits that are associated with     slow parasite clearance rates in vivo. To meet these aims, we are conducting a prospective,     longitudinal study to recruit Cambodian residents of Lumphat District in Ratanakiri Province     who complain of fever and/or symptoms of malaria. Patients diagnosed with uncomplicated     malaria will be treated with weight-based doses of artesunate given orally each day for 3     days followed by mefloquine given orally for 2 days. During this time, finger prick blood     smears will be obtained every 6 hours until parasite density is zero. From these data, we     will estimate parasite clearance rates using a half-life parameter. We will also collect     parasitized red blood cell samples from malaria patients prior to antimalarial drug     administration. These parasites will be tested in short-term in vitro culture experiments to     determine their susceptibility to artemisinins and other antimalarial drugs....   "
156098|NCT01240590|"     Background:      Anaplastic thyroid cancer (ATC) is one of the most aggressive of all solid tumors;     chemotherapy and surgery have had no impact on local control or survival of patients, with a     median survival of 3-7 months.      Crolibulin (EPC2407) is a microtubulin inhibitor that has been shown to have direct antitumor     effects in vivo and in vitro, destabilizing spindles and inducing apoptosis, resulting in the     disruption of neovascular endothelial cells with disruption of blood flow to the tumor. Early     clinical studies with combretastatin, from which crolibulin is derived, demonstrated efficacy     in a subset of patients with ATC.      Objectives:      The primary objective in the Phase I portion is to assess the safety and tolerability of     cisplatin and crolibulin given in a 21-day cycle in dose-seeking cohorts.      We will assess the toxicities of crolibulin coadministered with cisplatin, evaluate     dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) for the     combination.      The primary objective in the Phase II portion is to compare the combination crolibulin plus     cisplatin versus cisplatin alone in adults with ATC by assessing the duration of     progression-free survival (PFS); comparison of the response rates as evaluated by Response     Evaluation Criteria in Solid Tumors (RECIST) will be an important secondary objective.      We plan on biochemical and immunohistochemical analysis of several tumor parameters including     mitotic index, expression of several proteins including epidermal growth factor receptor     (EGFR), vascular endothelial growth factor receptor (VEGFR), BRAF, excision repair     cross-complementation group 1 (ERCC1) and tumor protein p53 (TP53). Where sufficient tissue     is available we will also perform gene expression analysis, micro ribonucleic acid (microRNA)     array analysis, and compare these with 3-deoxy-3 -[(18)F] fluorothymidine (FLT)-positron     emission tomography (PET) and tumor growth rate constant.      Eligibility:      Phase I: adults age 18 and older with unresectable, recurrent or metastatic solid tumors.      Phase II: adults age 18 and older with anaplastic thyroid cancer.      In the phase II portion disease must be evaluable by RECIST.      All patients must have adequate hepatic, renal, and bone marrow function.      Design:      The Phase I component consists of dose-escalation cohorts of three to six patients, in which     all patients receive both the study drug crolibulin with cisplatin. The MTD and DLT will be     determined based on toxicities during the first three weeks of combined therapy.      The Phase II component will be a randomization study, to either crolibulin with cisplatin or     cisplatin monotherapy. Patients randomized to cisplatin alone will have the opportunity the     opportunity to cross over to the crolibulin arm in the event of tumor progression.      Drug administration will take place on days 1, 2, and 3 for crolibulin, and on day 1 for     cisplatin, on a 21-day cycle.      Maximum number of patients for planned enrollment is 70. During the Phase I portion of the     study, dose-seeking cohorts of three to six patients will be enrolled until MTD / DLT is     reached for a maximum of three dose cohorts [up to 24 patients if one assumes an expansion     cohort to twelve patients at the recommended phase 2 (RP2) dose]. During the randomized Phase     II trial comparing the activity of the combination of crolibulin plus cisplatin with     cisplatin alone it is estimated that a maximum of 40 patients will be enrolled [1:1     randomization 20 + 20 = 40 patients], and we will allow for 6 extra patients to be enrolled     to compensate for a small number of non-evaluable patients.   "
156133|NCT01240122|"     An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS     at specific time points over the course of four days. The study was conducted with PureVision     lenses.   "
156099|NCT01240577|"     Background:      - The experimental drug IPdR is broken down in the body to IdUrd, which has been given to     patients to find out if it can improve radiation therapy. IdUrd has to be given through a     vein; therefore this new drug (IPdR) has been made which can be taken by mouth. Researchers     are interested in determining whether IPdR should also be studied to find out if it can     improve radiation therapy. The current study is to find out if people absorb the drug given     by mouth.      Objectives:      - To evaluate the levels of drug and its breakdown products in the blood following a single     dose of IPdR by mouth. .      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with cancer (solid tumors or     lymphomas) that have not responded to standard treatment.      Design:        -  This study involves an initial dosing visit, one day of admission to the hospital for          blood work, and a follow-up visit 14 days later.        -  Participants will be screened with a physical examination and medical history, as well          as blood and urine samples.        -  Participants will receive a single dose of IPdR, and will provide multiple blood and          urine samples for 24 hours after administration of the drug.        -  Fourteen days after receiving IPdR, participants will have another physical examination          and additional blood and urine tests to evaluate how IPdR has been broken down by the          body.        -  Cancer treatment will not be provided as part of this protocol.   "
156100|NCT01240551|"     Background:      - Sodium fluoride (NaF) is a common compound that is found in various foods and can be used     to increase bone strength. When this compound is added to a small dose of radiation (F-18),     it collects in the bones, with higher amounts in areas where the bone is rapidly changing,     such as the site of a healing fracture or a tumor. By giving F-18 NaF before a combined     positron emission tomography/ computed tomography (PET/CT) scan, researchers hope to be able     to better measure the changes in the bone that may indicate that a certain type of cancer     (such as prostate cancer) has spread to the bones.      Objectives:        -  To evaluate the effectiveness of F-18 NaF in imaging studies to measure bone tumors and          their change over time and compare with clinical course, in individuals with prostate          cancer.        -  To determine the smallest amount of change in the bone tumors that F-18 NaF can          accurately measure.      Eligibility:      - Men at least 18 years of age who have been diagnosed with prostate cancer and have had     imaging studies to determine whether the cancer has spread to their bones. Both patients with     and without known bone involvement will be enrolled.      Design:        -  Participants will be screened with a physical examination, medical history, and imaging          studies, and will provide baseline blood samples to evaluate kidney function.        -  For the study, participants will have two F-18 NaF PET/CT scans on separate days for          baseline. These repeat scans will be used to determine the amount of change that is due          to the imaging process alone (i.e. not due to the disease getting better or worse.          Participants will receive a dose of F-18 NaF intravenously, and will have PET/CT          scanning over the body (mid ear to upper thighs) over 1 hour, the body followed by a          complete whole-body PET/CT scan at approximately 2 hours after F-18 NaF injection.          Participants will be watched closely for side effects from the F-18 NaF until the scans          are done, and will be asked to drink plenty of water to void the F-18 NaF from the body          after the scans.        -  As a followup study, participants will have two more F-18 NaF PET/CT scans, one 4 to 8          months after the first scans and then one 10 to 14 months after the first scans.          Participants will provide additional blood samples before the followup scans.   "
156101|NCT01240538|"     This phase I trial studies the side effects and the best dose of viral therapy in treating     young patients with solid tumors that have come back or that have not responded to standard     therapy. Some tumors have cells with a genetic weakness that makes them unable to fight off a     virus called wild-type reovirus. The virus causes cells with this weakness to die, and may     therefore be able to kill tumor cells without damaging normal cells. Cyclophosphamide is a     drug used in chemotherapy that stops tumor cells from dividing and causes them to die. Giving     wild-type reovirus together with cyclophosphamide may kill more tumor cells.   "
156102|NCT01240525|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a     donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's     immune system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor     effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) that have been     treated in the laboratory after the transplant may help increase this effect. Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving alemtuzumab before transplant and cyclosporine after transplant, may stop this     from happening.      PURPOSE: This randomized phase II trial is studying donor lymphocyte infusion after stem cell     transplant in preventing cancer relapse or cancer progression in patients with follicular     lymphoma, small lymphocytic non-Hodgkin lymphoma, or chronic lymphocytic leukemia.   "
156103|NCT01240512|"     This is a randomized, double-blind, multicenter, 6-month follow-up trial of low (400 IU/day)     versus high (4000 IU/day) dose vitamin D supplementation in individuals with pre- and early     stage 1 hypertension and vitamin D deficiency. A total of 530 participants (265 participants     per treatment arm) will be randomized between 3 sites. Approximately 2,250 participants will     be screened between the 3 sites. Vital signs, 24-hour ambulatory blood pressure monitoring,     clinical laboratory safety tests and adverse event assessments will be performed to evaluate     the effectiveness of the two doses of vitamin D on blood pressure. Blood samples will be     stored for future biomarker assessments. The total duration of the study is anticipated to be     18 months, assuming a 12 month enrollment period.   "
156104|NCT01240499|"     The purpose of this study is to measure the effects of a Health-At-Every-Size (HAES) approach     on global health status of premenopausal overweight women preoccupied about their weight and     who have been unsuccessful in previous weight loss attempts.   "
179017|NCT00189735|"     A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant     patients   "
156106|NCT01240473|"     Kala azar (KA) or visceral leishmaniasis (VL) is endemic in several districts of Bangladesh     with the highest incidence in Mymensingh, Pabna and Tangail districts. ICDDR,B is involved in     a project for improving the surveillance of KA in Trishal, Mymensingh since 2005. Improvement     of case detection is necessary for both surveillance purposes and better control. The aims of     this pilot study are to assess some newer techniques for diagnosis of KA using blood and     urine samples of suspected cases; and evaluate response to treatment with sodium     stibogluconate to which resistance has been reported in India, considered to be a part of the     same zone harboring the disease agent Leishmania donovani and transmitted by the same vector     Phlebotomas argentipes (sand-fly). No data is currently available on response to sodium     stibogluconate in KA patients in Bangladesh. Although a number of new drugs have been     evaluated in the treatment of KA in India and Kenya, no trial has so far been conducted in     Bangladesh. A team of researchers from GlaxoSmithKline (UK) had recently visited Bangladesh     to evaluate if it would be possible to conduct a Phase-III clinical trial with sitamaquine.     They interacted with scientists of ICDDR,B and expressed their interest to help develop     ICDDR,B's capacity in order to include Bangladesh as one of the sites for the planned,     multi-centre, Phase-III trial of sitamaquine; India and Nepal are two other possible sites     for the trial. The aims of the proposed study are to train physicians and laboratory     personnel in preparation for the future drug trial(s) on KA as well as to compare different     tests for its diagnosis that might improve case detection at the field level and used for     research purposes. The investigators will also examine in greater detail the different     Leishmania species circulating in the area of Mymensingh and whether treatment failure and     occurrence of Post Kala azar Dermal Leishmaniasis (PKDL) is associated with certain species.   "
156107|NCT01240460|"     The purpose of this study is to measure what effect the study drug XL765 (SAR245409) or the     study drug XL147 (SAR245408) has on tumor tissue in subjects with recurrent glioblastoma (GB)     who are candidates for surgical resection. XL765 (SAR245409) and XL147 (SAR245408), the two     investigational agents examined in this study, XL147 (SAR245408) is a potent inhibitor of PI3     Kinase (PI3K) and XL765 (SAR245409) is a dual PI3K and mTOR inhibitor. In preclinical     studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis     (programmed cell death) in tumor cells.   "
156108|NCT01240447|"     This study is designed to evaluate safety and immunogenicity of racotumomab in patients with     advanced Non-small Cell Lung Cancer (NSCLC), in concomitance with chemotherapy (docetaxel)     when a second-line therapy is indicated. The study will also compare survival and progression     free survival on both study arms.   "
156109|NCT01240434|"     The investigators perform a simple-blind randomized trial with two groups, one in which all     the orifices are closed by suturing the external fascia of the abdominal wall (Group A), and     another in which the orifices are left open, closing only the skin (Group B). Monitoring for     trocar site hernia lasted 2 years from the intervention.   "
156110|NCT01240421|"     This expanded access program is an open-label, multi-center study, which will consist of a     PreTreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast     cancer who fulfill the eligibility criteria will be treated. The program will continue in     each country until eribulin is approved, reimbursed and launched in that country, or     termination of the program by the Sponsor.   "
156111|NCT01240408|"     This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy     subjects. The study will consist of two phases: Pre-randomization and Randomization. The     Pre-randomization phase will have two periods: Screening and Baseline. In the Randomization     Phase, subjects will be randomized to one of two possible treatment sequences (fed/fasted and     fasted/fed). In each period, subjects will receive a single capsule containing 10 mg     lenvatinib either with or without a standard breakfast. There will be a 2-week washout     between treatments.   "
156112|NCT01240395|"     The objective of this study is to evaluate the effect of mindfulness-based cognitive therapy     (MBCT) on physical symptoms attributed to chemical exposures, psychological distress, illness     worry, quality of life, and illness perceptions in patients suffering from multiple chemical     sensitivity (MCS). Furthermore, a secondary objective is to evaluate whether a possible     symptom reduction is mediated by an increased level of mindfulness.      The primary hypothesis is that the self-reported severity of MCS symptoms and the degree to     which chemical exposures causes symptoms and the impact on daily life will be significantly     improved in the MBCT treatment group as compared to the control group.   "
156113|NCT01240382|"     To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6     times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate     ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical     administration), is at least non-inferior in the change in fluorescein staining score, and is     superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group     comparison study. Safety profile will likewise be compared.   "
156114|NCT01240369|"     Lung cancer and esophageal cancer remain the leading causes of cancer death worldwide. The     main problem is lack of effective tool in early detection that accounts for the poor outcome     of cancer. Clinically, over 80% of patients with cancer were at late stage when they were     diagnosed. Therefore, it is important for us to find the biomarker that serve as the early     prediction of cancer.      The investigators have published that VEGFC over-expressed in non-small cell lung cancer.     VEGFC plays a critical role in regulating motility of tumor cells, promotes proliferation of     lymphatic endothelial cells and enhances migration and invasion. Investigator found that     VEGFC over-expressed in the serum of esophageal cancer patients. Therefore, it is worthwhile     to investigate the correlation between VEGFC, clinical lung cancer and esophageal cancer.      MicroRNAs (miRNAs) are conserved, endogenous, small, and noncoding RNA molecules of 21~23     nucleotides that function as post-transcriptional gene regulators. Recent studies indicated     that certain microRNAs reduced in cancer patients. Therefore it is important to investigate     whether specific microRNA changed in certain kinds of cancer patients.   "
156115|NCT01240356|"     The purpose of CLOTBUST-HF is to determine the safety of a novel, external Hands-Free     transcranial Doppler (TCD) ultrasound system in healthy volunteers and ischemic stroke     patients. If found to be safe, the widespread use of operator-independent,     ultrasound-enhanced thrombolysis will allow the planning for a large Phase III efficacy     trial.   "
156116|NCT01240343|"     The purpose of this study is to develop a BioBank (a specialized lab) and collect blood,     fluids and/or other tissue samples to study eye diseases.   "
156117|NCT01240330|"     The objective of this clinical study was to demonstrate the performance of the Vasculaire     Compression System to increase femoral venous peak velocity (PFV) in healthy subjects. This     study was a single-arm, open label, prospective, single-center clinical study.   "
171870|NCT00088062|"     The purpose of this study is to determine the safety and tolerability of STA-5326 given once     daily or twice daily to Crohn's Disease patients with moderate disease.   "
156118|NCT01240317|"     In this study, the investigators are testing the expert system called eVENT. eVENT provides     expert advice about the patient's breathing. The investigators have developed and tested a     prototype of eVENT and now want to test how it works in practice. To do this the     investigators plan to use computer based simulations and test it when used by     anesthesiologists in a full size human simulator. If these tests are successful the     investigators will then be ready to evaluate eVENT on real patients.   "
156119|NCT01240304|"     The purpose of this phase II clinical trial study is to assess the resection rate among     subjects who have been initially diagnosed with unresectable or borderline resectable     pancreatic adenocarcinoma. This will be done by providing preoperative treatment that will     include alternating cycles of chemotherapy and radiotherapy treatment. In addition, this     clinical trial will assess the safety of preoperative chemotherapy with radiation therapy for     subjects with unresectable or borderline resectable adenocarcinoma of the pancreatic head,     assess margin-negative resection rates, disease-free survival, assess overall survival rates,     and determine patterns of local and distant recurrence.   "
156121|NCT01240278|"     Increased mammographic density is recognized as an important risk factor for developing     breast cancer, however, the underlying mechanism explaining this relationship is unclear. The     investigators hypothesize that Molecular Breast Imaging (MBI) can more accurately distinguish     dense tissue on mammography which is at high risk from dense tissue at low risk by indicating     cellular activity in dense tissue as radiotracer uptake (functional density) in the breast.     In this pilot study, the investigators want to compare the histological characteristics of     breast tissue in patients with who have similar density on mammography but different levels     of functional density on MBI.   "
156122|NCT01240265|"     Adequate vitamin D is essential for proper infant growth and development. However, human milk     is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is     to assess the feasibility of providing adequate vitamin D to breastfed infants through     maternal vitamin D supplementation. Forty non-pregnant, lactating women at least 18 years of     age with exclusively breastfed infants between the ages of 1 and 6 months will be randomized     to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a single     dose. Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary calcium;     maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28 of the     study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.   "
156123|NCT01240252|"     The study is being conducted to find out why too much fat in your blood stream may cause     insulin resistance in your muscles. Insulin is the hormone, produced normally by your body,     which causes your blood sugar to return to normal after you eat.   "
156124|NCT01240239|"     The purpose of the study is to evaluate different methods of pre-anesthesia consultation,     with the aim of improving the day of surgery experience for the patient. In this study, we     will use a telephone consultation, an in-person consultation, and a telemedicine     consultation, which involves television cameras and monitors that allow live two-way     communication for the pre-anesthesia consultation. The reason for this study is to evaluate     the use of telemedicine for the pre-anesthesia consultation. Patients and anesthesiologists     have been highly satisfied in previous studies using pre-anesthesia telemedicine     consultation. In this study, we will examine a larger group of patients, as previous studies     have studied smaller groups of patients.   "
156125|NCT01240226|"     This will be a single-center, open-label, randomized, 2-part study to determine the relative     bioavailability of GDC-0941 capsule and market-image tablet formulations and the effect of     ketoconazole on the pharmacokinetics of the GDC-0941 market-image tablet formulation.   "
156126|NCT01240213|"     Experimental and human data suggests that vitamin D could protect against breast cancer.     Overweight/obese individuals are at increased risk of low vitamin D levels. Vitamin D may     reduce production of fat tissue, thereby reducing weight gain, which would result in lower     levels of adipose-derived hormones and other breast cancer risk factors.The purpose of this     study is to test the effect of vitamin D supplementation on the response to a weight loss     (diet + exercise) intervention and select breast cancer risk factors in overweight and obese     postmenopausal women with low blood vitamin D levels.   "
156127|NCT01240200|"     Several studies have shown that high blood sugar (glucose) levels are associated with     diseases caused by the diabetes. Controlling the glucose may prevent these complications. As     people age, their bodies become unable to make enough insulin to control the blood sugars.     Pills used to treat diabetes may help for a while, but many times this does not last. When     the blood sugar is too high, insulin is frequently recommended and used to treat diabetes.     Insulin is often started by adding a long-acting insulin to the medicines a patient already     takes. In this study, glargine insulin will be taken together with the diabetes pills     currently being used. Glargine is a long-acting insulin which is given under the skin once a     day. Glargine is approved for use in the treatment of patients with diabetes by the FDA (Food     and Drug Administration).      Currently, insulin delivery is only available as a shot. The purpose of this study is to     compare how satisfied patients are when using two different types of insulin shots.     Specifically, this study aims to determine if people over 65 years old are more satisfied     taking insulin shots by pens or syringes. Everyone who joins in this study will have a chance     to use the insulin syringes and the insulin pens.      The ability of patients to give themselves shots can affect how well the sugar is controlled.     As people age, medical and other problems may develop that affect their ability to do certain     things. Another aim of this study is to determine if the ability to use an insulin pen and     insulin syringe is affected by age or some other problem.      During this 25 week long study, patients will be treated with insulin given by a syringe for     12 weeks and by a pen for 12 weeks. Questionnaires will be given to determine satisfaction     with treatment throughout the study. The investigators hypothesize that among elderly     patients with type 2 diabetes mellitus failing oral agent therapy, treatment with basal     insulin via a pen device results in higher treatment satisfaction scores and more accurate     dosing than treatment with basal insulin via conventional vial/syringe methods.      A total of 56 subjects with type 2 diabetes will be recruited into this study. The site for     the study is Grady Memorial Hospital clinics.   "
156128|NCT01240187|"     The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and     one 12 mg tablet of perampanel in healthy subjects.   "
156172|NCT01239615|"     Aim: To study the stability of brain MR-scanning parameters (blood-flow, microstructure,     volume, metabolism) over 1 week in health volunteers.      Hypothesis: MR-scanning parameters are stable over 1 week in healthy volunteers   "
156174|NCT01239589|"     This study is being carried out to find out how patients suffering from the acute manic phase     of bipolar disease are currently managed with Quetiapine Immediate Release (IR) or Quetiapine     Extended Release (XR) in the hospital setting in real life practice, including length of     stay.   "
156129|NCT01240174|"     Studies show, guidelines state, and performance measures assert that antibiotic prescribing     for uncomplicated acute bronchitis is inappropriate. However, clinicians prescribe     antimicrobials in over 60% of the 22.5 million acute bronchitis visits in the United States     each year. Previous successful interventions have only reduced the antimicrobial prescribing     rate to 40% or 50%. It is unknown if the antimicrobial prescribing rate for acute bronchitis     can be brought to near zero percent in actual practice while maintaining patient safety and     satisfaction. The goal of this study is to develop an Electronic Health Record     (EHR)-integrated algorithm for the diagnosis and treatment of adults with acute bronchitis     with a goal of reducing the antibiotic prescribing rate to near zero percent.   "
156130|NCT01240161|"     The central hypothesis for this proposal is that multimodal (clinical, imaging, tissue)     biomarkers will better predict early brain tumor response to treatments and will be more     reliable prognostic markers in patients with malignant brain tumors.   "
156131|NCT01240148|"     The purpose of this study is to investigate the effect of AZD3161 on mechanical pain     sensitivity and axon reflex flare in normal and ultraviolet C irradiated skin.   "
156132|NCT01240135|"     The purpose of this study is to evaluate the clinical performance of a silicone hydrogel     contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).   "
156134|NCT01240109|"     The objective of this study was to compare the effect of remifentanil on suppression cough     reflex during emergence in patient anesthetized using either propofol or sevoflurane     additionally under infusion of the identical concentration of remifentanil.   "
156135|NCT01240096|"     Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo,     followed by 8 weeks of open-label mirtazapine 15 mg daily   "
156136|NCT01240083|"     Repetitive Transcranial Magnetic Stimulation (rTMS) as well as Theta- Burst Stimulation of     the frontal cortex are used to modulate the neuronal excitability in patients with     depression. In the proposed study we investigate whether high frequent rTMS or Theta-Burst     Stimulation of the DLPFC is more effective in patients with a depressive episode.   "
156137|NCT01240070|"     Despite several clinical trials have clearly demonstrated that the correction of a single     cardiovascular risk factor in patients with type 2 diabetes decreases the incidence of     myocardial infarction and other cardiovascular disease (CVD) events, only the Steno study has     been evaluating the effect of a multifactorial intervention strategy on macrovascular     complications of diabetes. For this reason, the disease management approach currently     endorsed by international guidelines (i.e correction of all major CVD risk factors to target     levels usually lower than lower risk populations) has not been extensively investigated in     terms of prevalence of application in current clinical practice and in terms of real     efficacy.      The Multifactorial INtervention in type 2 Diabetes - ITaly (MIND.IT) is a multicentric     two-phase study involving 9 Diabetes Care Units throughout Italy with the overall aims of:     (1) investigating the degree of application of the international guidelines for CVD     prevention in type 2 diabetic patients and (2) verifying whether the application of an     intensive multi-factorial intervention inspired by these guidelines is feasible and effective     in decreasing the incidence of new CVD events.   "
156138|NCT01240057|"     This trial investigates whether prenatal intervention improves survival rate of fetuses with     isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to     expectant management during pregnancy, both followed by standardized postnatal care.   "
156139|NCT01240044|"     This study intend to assess the pain intensity of newborns in neonatal intensive care unit     (NICU) undergoing different techniques of respiratory therapy and compare these procedures. A     randomized controlled clinical trial and blind trial with newborns admitted to NICU. The     babies were categorized according to gestational age , age, weight, diagnosis, support and     signs of respiratory distress. Then, they were allocated by lot to come from one of 3 groups:     G1 - control, G2 - undergoing physical therapy; G3 - received the thoracoabdominal     rebalancing. Each newborn received just one physical therapy session in that they were     assessed before one of the three procedures (T1), immediately after (T2) and after 15 minutes     (T3). This evaluation found cardiorespiratory parameters (oxygen saturation, heart and     respiratory rate) and three specific scales for pain assessment (NIPS, NFCS and PIPP). The     hypothesis is that newborns hospitalized in intensive care unit did not show pain when     undergoing respiratory therapy.   "
156140|NCT01240031|"     The purpose of this study is to determine whether individualised nutritional therapy     comprised of appetising, energy- and protein-rich foods can have a positive effect on     physiological function and quality of life of undernourished patients as compared to usual     nutrition care.   "
156141|NCT01240018|"     The aim of the ProSat study is to examine the effects of a probiotic capsule containing Lb.     Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone     response in a single meal test and to determine whether the acute effects persist after daily     supplementation of the probiotic capsule.   "
156142|NCT01240005|"     30% of renal cell carcinoma patients have metastases, mostly in lung, liver and bones at the     time of diagnosis. Because of poor response to radiation therapy or chemotherapy, several     studies have been initiated to find alternative therapeutic options.      Cytokine induced killer cells(CIK) are an unique population of cytotoxic T lymphocytes with a     characteristic CD3+ CD56+ phenotype; they can be generated from cytokine cocktail-induced     peripheral blood mononuclear cells (PBMC). CIK cells represent strong anti-tumor cytotoxicity     in vitro and in vivo. Interestingly,the anti-tumor activity of CIK cells can be enhanced by     incubation with dendritic cells (DC), which are the most potent antigen (Ag)-presenting     cells.      The purpose of this study was to evaluate the clinical efficacy of DC-activated CIK cell     treatment following regular therapy and the effects of this therapy on immune responses in     patients with renal cell carcinoma after surgery.   "
156143|NCT01239992|"     The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial     lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and     postprandial biomarkers of endothelial dysfunction and inflammation.   "
171891|NCT00090233|"     This study was designed to evaluate the safety of the investigational rotavirus vaccine and     the efficacy to prevent rotavirus gastroenteritis.   "
156145|NCT01239966|"     In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical     ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold     standard for supportive care. However, despite a relative low tidal volume, approximatively     one third of patients will experienced tidal hyperinflation, a phenomenon known to induce     pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4     ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia     and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra     corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.      Patients with ARDS also frequently develop acute renal failure which may required Renal     Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.      The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of     patients presenting ARDS and acute renal failure will allow the tidal volume to be further     reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased.      For this purpose, the investigators sought to evaluate the safety and efficacy of adding a     membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the     hemofilter.   "
156146|NCT01239953|"     Treatment of patients with bare metal stent restenosis remains a challenge. This study will     assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent)     is superior in the treatment of patients suffering from bare metal stent restenosis.   "
156147|NCT01239940|"     Treatment of patients with drug-eluting stent restenosis remains a challenge. This study will     assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent)     is superior in the treatment of patients suffering from drug-eluting stent restenosis.   "
156148|NCT01239927|"     This prospective randomized trial is to prove the equivalence of primary sigmoid resection     with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis     with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with     peritonitis caused by perforated left-sided colon diverticulitis.   "
156149|NCT01239914|"     COACT registry is a multicenter registry of consecutive patients undergoing coronary stent     implantation at 8 centers in the Catholic University of Korea to evaluate the real world     management of patients with coronary artery disease and to assess their in-hospital, medium     and long-term outcomes.   "
156150|NCT01239901|"     The purpose of this research study is to determine the frequency and severity of iron     overload in patients with Sickle Cell Anemia and its relationship to blood vessel function.     The investigators hypothesize that intermittent transfusions that these patients receive     during hospitalizations produces significant iron overload and impairs blood vessel     relaxation.   "
156151|NCT01239888|"     The purpose of this study is to determine whether an oxytocin ad-on, or oxytocin and tibolone     ad-on can induce a response to antidepressants in patients with treatment resistant     depression.   "
156152|NCT01239875|"     RATIONALE: Vaccines, such as dendritic cell therapy (DC) made from a person's tumor cells and     white blood cells may help the body build an effective immune response to kill tumor cells.     Cryosurgery kills cancer cells by freezing them. Giving vaccine therapy together with     cryosurgery may kill more tumor cells. PURPOSE: This clinical trial studies giving vaccine     therapy together with or without cryosurgery in treating patients with B-cell Non-Hodgkin's     lymphoma.   "
156153|NCT01239862|"     The aim of this study was to analyze the safety, pulmonary function, and quality of life data     of patients with silicosis treated with intrabronchial instillation of bone marrow derived     mononuclear cells (BMDMC, 2x107) through bronchoscopy.   "
156154|NCT01239849|"     Because Diabetes Mellitus is one of the major risk factors for CV disease and lots of related     evidences have been published including CARDS study that showed definite benefit of statin     treatment in DM patients and influenced ADA guideline. & NCEP ATP III update. However, there     are large unmet medical needs for DM patients who don't reach their target LDL-C level     defined NCEPT ATP III update because of physicians usually start with the lowest dose of     statin and then titrate to the goal. Thus, we are curious about changing our prescription     pattern into more tailored way; selecting starting dose based on the individual risk factors     and concomitant status will impact the goal achieving rate for DM patients. Besides that, we     are going to find out preliminary data about other markers change; small dense LDL and     adiponectine;. Small dense LDL-C is more inflammatory and atherogenic LDL-C that may explain     the impact of triglyceride. Adiponectin is another good marker related with obesity and     metabolic syndrome.   "
156155|NCT01239836|"     Urinary incontinence is a common and bothersome condition that remains frequently untreated     among senior women. The aim of this trial is to compare the effectiveness of two     community-based continence promotion interventions aimed at improving rates of self-care     and/or professional health-care seeking in older women with urinary incontinence. The main     hypothesis posits that participation in a constructivist interactive workshop combined with     use of an evidence-based self-management tool will yield rates of improvement in incontinence     frequency and reduce the cost of pad use by 20% compared to either intervention alone, which     individually are expected to yield minimal effect sizes of at least 0.3 compared to a sham     intervention.   "
156156|NCT01239823|"     The purpose of this randomized, controlled trial is to determine whether a vibration platform     exercise program will be more effective than a standard platform exercise program in     improving quadriceps strength in women age 45-60 who have risk factors for knee     osteoarthritis. Each platform exercise program will be conducted 2 times a week for 12 weeks.     The sessions will consist of a series of exercises on a Wave Pro-elite vibration platform     (with 1-3 minute rests between sets) and stretches with the platform vibration either turned     on (intervention group) or off (control group.) Quadriceps strength (primary outcome), leg     press power, and vibration sense will be assessed at baseline and 12 weeks, and changed     scores will be compared between groups.   "
156173|NCT01239602|"     Stem cell theray in old stroke patients is a study to treat stroke patients approved before     in our hospital. We recruit these patients who received stem cell therapy and completed the     study. We adopted movement-related cortical potential,and cortico-cortical inhibition to     assess the stroke patients with or without stem cell therapy. Further analyzing the     correlation of the motor related cortical potential and cortico-cortical inhibition among     them. We wanted to find out if there are changes in cortical excitability in subjects with     chronic stroke after stem cell therapy.   "
156157|NCT01239810|"     Objective:      To assess the impact of intraarticular hyaluronic acid (HA) on clinical outcome and on     volumetric and T2 relaxation based changes of articular cartilage in mild to moderate     osteoarthritis (OA) of the knee joint.      Methods:      Patients with moderate OA of the knee [Kellgren-Lawrence II] were recruited for a 6-months     prospective, randomized clinical trial evaluating the effect of HA on articular cartilage     morphology and composition. Clinical examinations and MRI were performed at baseline, and     after 6, 12 and 24 weeks. Cartilage volume, thickness and surface area were determined in     cartilage plates and subregions were defined using proprietary software. MRI was performed on     a 1.5 Tesla scanner; morphological evaluation was performed using 3D T1-w FLASH     Waterexcitation (WE) sequences and T2 maps were calculated from a multiecho, spin-echo     sequence.   "
156158|NCT01239797|"     The purpose of the study is to determine whether the addition of Elotuzumab to     Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).   "
156159|NCT01239784|"     The purpose of this project is to investigate the feasibility of using a home-based,     parent-delivered model for providing neurodevelopmental rehabilitation programmes to infants     who have had surgery for a complex heart defect.   "
156160|NCT01239771|"     The purpose of the study is to assess safety, tolerability and pharmacokinetics of TC-5214 in     medically stable elderly subjects following multiple oral doses.   "
156161|NCT01239758|"     To evaluate the long-term safety and tolerability of ACE-031 administration in subjects with     Duchenne muscular dystrophy (DMD) who participated in Study A031-03. [Note: This study was     terminated based on preliminary safety data. Pending further analysis of safety data and     discussion with health authorities, a new ACE-031 trial will be planned.]   "
156162|NCT01239745|"     This non-interventional study will be conducted in several Eastern European countries to     assess the safety, tolerability and efficacy of Aromasin® when it is administered in     real-word setting in postmenopausal women with invasive estrogen receptor positive early     breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and     continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal     therapy, to understand how Aromasin® is used in routine clinical practice, to assess     adherence to prescribed Aromasin® treatment and to understand reasons for its early     discontinuation.   "
156163|NCT01239732|"     This open-label, non-comparative, multi-center study will assess the safety profile and     efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in     participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal     carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously     (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the     plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of     8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3 weeks or 80     mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108     weeks or until disease progression or unacceptable toxicity.   "
156164|NCT01239719|"     The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine     fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of     allergic dermatitis.   "
156165|NCT01239706|"     Prospective, Open Label, Cohort Study in Traumatic Brain Injury Patients. The goal of this     study is to assess the safety of NTx®-265. NTx®-265 will be administered over 9 days, and     patients will be followed for an additional 6 months.   "
156166|NCT01239693|"     The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have     been associated with improved growth and development outcomes among infants in Ghana and     Malawi. Modified versions of such supplements have been developed to improve their nutrient     density and quality and to lower their costs. Such modified products have proven acceptable     to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test     the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating     women and their infants from 6 to 18 months of age. In control groups, participants will     receive either iron+folate tables during pregnancy only or multiple micronutrient tablets     during pregnancy and first six months of lactations. The main hypothesis to be tested     suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS     between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and     the first 6 months of lactation is higher than the mean LAZ score of same age infants who     received no dietary supplements and whose mothers received iron-folate supplementation during     pregnancy only.   "
156167|NCT01239680|"     Overall aim of this work is to evaluate new methods of resuscitation that can be applied by     front-line responders on the battlefield, in civilian life, or which can be used during     initial resuscitation in the first fixed facility to which the injured patient is brought.   "
156168|NCT01239667|"     Hypothesis and objectives of the study Systematic preparation of rehabilitation plan for     rehabilitation in Phase III based on identification of self-care behavior patients with heart     failure in NYHA class II and III, leading to patients' self-care behaviors strengthened,     which will result in increased health status and ADL level 6 months after discharge from     hospital with heart failure .      Target        1. To develop evidence-based clinical guidelines for patient rehabilitation phase III        2. To test the effect of individual rehabilitation plans based on clinical guidelines for          patient rehabilitation in Phase III. Efficacy evaluated in relation to changes in          self-care behaviors, health status and ADL function.      Material and Methods:      Controlled longitudinal study. Each intervention patient receives before the end of hospital     rehabilitation designed a specific rehabilitation plan also contacted the patient by     specially trained nurse telephone 4 and 12 weeks after completion of their rehabilitation in     hospital and the patient has the opportunity to contact the department when needed. The     effect of rehabilitation assessed by sending questionnaires SF 36 and EHFScB Scale 9, to     assess patients' ADL functioning, self-care behaviors and self-rated health.      All patients participating in the planned rehabilitation in hospitals, so that the baseline     is the end of Phase II. Intervention based on an analysis of the individual's need for     continued rehabilitation (self care behavior, health status, ADL function) and the patient's     perception of own situation. Draw up a plan and program together with the patient   "
156169|NCT01239654|"     It is an exploratory study evaluating a biological effect (stent strut coverage) using a     novel technology such as OCT without any clinical implication.   "
156175|NCT01239563|"     The purpose of this study is to determine if anti-thymocyte globulin (Thymoglobuline)     administration in the kidney transplant recipient is able to reduce the amount of damage that     kidneys transplanted from deceased donors sustains on reperfusion.   "
156176|NCT01239550|"     The purpose of this study is to evaluate the effects of the medication insulin detemir on     weight, brain function and mood, and on blood vessel and other risk factors for heart     disease. The study will compare how diet and insulin detemir affect areas of the brain that     are involved in food intake and the sense of pleasure people get from eating.      Participants will be randomized into one of 2 groups. Group 1 will follow a low calorie diet     only. Group 2 will follow a low calorie diet and take insulin detemir.      The study is 26 weeks in length and include outpatient visits, inpatient visits, phone and     email contact, questionnaires, diary collection, blood draw and procedures involving MRI and     PET scans. There are 4 inpatient visits at the Vanderbilt Clinical Research Center (CRC). The     inpatient visits require a one night 2 day stay on the CRC at Weeks 2, 6, 16, 26. During the     weekly and bi-weekly outpatient visits participants will meet with the study nurse and     dietitian.   "
156678|NCT01233219|"     Identification of the genetic polymorphisms that could be correlated either with a better     clinical response or with a major predisposition of patients to develop tolerance and/or side     effects to the treatment with morphine.   "
156177|NCT01239537|"     In 2009 the World Health Organization (WHO) declared the Influenza A H1N1 (swine 'flu)     outbreak the first global pandemic of this century. It is thought to have been responsible     for 16,226 deaths globally as of 21st February 2010. The investigators know from previous     influenza outbreaks that the number of cases also tends to increase during the winter season     of the years after a pandemic. There is concern that last year's pandemic influenza strain     will return this winter and it has, therefore, been included in WHO's recommendations for     seasonal influenza vaccine combinations.      This study will assess the duration of the immune response to the H1N1 influenza vaccines     given last year, and how children will respond to this year's seasonal trivalent influenza     vaccine (which includes the H1N1 strain). Participating children would receive one dose of a     licensed seasonal influenza vaccine and blood tests would be taken before and after     vaccination.   "
156178|NCT01239524|"     Breast reconstruction with a pedicled myocutaneous latissimus dorsi (LD) flap is a widely     used reconstruction method. It is controversial if surgical denervation by transecting the     thoracodorsal nerve should be performed or not. It is assumed that after denervation the     latissimus dorsi muscle will significantly atrophy and lose volume. On the other hand     discomforting signs and symptoms from muscle contraction are believed to be prevented if flap     is denervated. The aim of the study was prospectively evaluate the influence of LD-flap     innervation on the functional and aesthetic outcome of delayed breast reconstruction, and to     compare the change in muscle structure in breast MRI and histopathology.   "
156179|NCT01239511|"     The objective of this study is to evaluate the dose-response of three different dose levels     of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in     patients with chronic stable angina.   "
156180|NCT01239498|"     The investigators hypothesize that injection of saline to the upper eyelids prior to     lidocaine/adrenaline injection will reduce pain of the local anesthetic in comparison to     injection of lidocaine alone.   "
156181|NCT01239485|"     The purpose of this study is to determine the maximum tolerable dose of irinotecan in     combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric     patient.   "
156182|NCT01239472|"     Currently, acute kidney injury is diagnosed by increased serum creatinine. However,     creatinine is not a reliable marker for acute changes in renal function.      The biology of the renal graft is influenced by chemokines from reperfusion and throughout     its course with the development of interstitial fibrosis and tubular atrophy ubiquitously     present in grafts of long-term survival. Moreover, the evaluation of changes in urinary     cytokines may predict renal function and acute rejection episodes and their response to     treatment.      Today there are several studies comparing the relative immunosuppression of renal function,     but few noticed its relationship with cytokines and chemokines. Thus, we propose to study the     inflammatory consequences on blood and urine with the early withdrawal of calcineurin     inhibitors (ICN), with renal biopsy in renal transplant patients before the change of     immunosuppression and 9 months after.   "
156183|NCT01239459|"     Primary Objective:      - To determine the effect of severe renal impairment on the pharmacokinetic profile of     teriflunomide administered as a single 14 mg dose as compared to healthy subjects      Secondary Objective:      - To assess the tolerability of teriflunomide administered as a single 14 mg dose in subjects     with severe renal impairment compared to subjects with normal renal function.   "
156184|NCT01239446|"     Mediastinal irradiation for treatment of malignancy increases the risk for coronary artery     disease (CAD), while diabetes mellitus or other known risk factors can be absent at the time     of the first coronary event. Radiation-induced atherosclerosis affects the coronary ostia and     proximal coronary segments, or causes diffuse microvascular damage. Younger patients and     those exposed to high radiation doses (> 35 Gy) have a higher risk for developing premature     CAD and likely may benefit from coronary assessment.      A novel hybrid imaging technique that combines SPECT and CTCA has been shown to overcome the     individual pitfalls and the diagnostic challenges of stand-alone SPECT and CCTA, improve the     lesion detectability and sensitivity in patients with balanced diffuse lesions as well as the     specificity and mainly PPV of CTCA.      The aim of the study is to perform hybrid SPECT/CTCA in asymptomatic patients with HL who     have received radiotherapy to the mediastinum in order to allow an early diagnosis of     hemodynamically significant CAD that will need further therapeutic interventions.   "
156185|NCT01239433|"     Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this     study pressure changes are examined in a mechanical lung model and in a population of ICU     patients on mechanical ventilation.   "
156186|NCT01239420|"     The purpose of this study is to evaluate the use of combined clinical-neurological,     neurophysiologic, neuroradiological and biochemical markers in prognostication after cardio-     and/or respiratory arrest.   "
156187|NCT01239407|"     The purpose of this study is to determine if a culturally focused psychiatric (CFP)     consultation service can improve depressive symptoms and increase diagnosis and treatment of     depression in Asian American and Latino American primary care patients at the Massachusetts     General Hospital.   "
156869|NCT01230450|"     Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study     for comparing the relatively new Single incision sub-urethral tapes with the standard     surgical treatment of female urodynamic stress incontinence (USI).   "
156188|NCT01239394|"     Ofatumumab is a drug that works by attaching to the CD20 molecule found on the surface of     cancerous B cells, and then triggering the death of those cells. It is approved by the FDA     for treatment of another B-cell cancer, chronic lymphocytic leukemia, and also has evidence     of success in people who's B-cell lymphomas have relapsed after initial treatments. In this     research study we are looking to see if ofatumumab is effective and safe in treating     previously untreated B-cell NHL.   "
156189|NCT01239381|"     Stereotactic body radiation therapy (SBRT) is a technique that is used to deliver radiation,     to sites in the body. All participants in this study will be treated with SBRT using proton     beam radiation. Proton beam radiation uses tiny particles to deliver radiation to tumors. The     purpose of this research study is to determine if SBRT with protons will prevent tumor growth     and reduce the treatment side effects for liver metastases.   "
157273|NCT01225120|"     The purpose of this repeated measures design gait training study is to develop and     quantitatively assess the effectiveness of a virtual reality training environment using     real-time feedback for modification of pelvic motion during gait.   "
156190|NCT01239368|"     Background:      - Cancer development is associated with problems in immune system functions, which prevent     the body from attacking and destroying the abnormal cells that lead to tumor growth. Research     has suggested that certain white blood cells, known as Th1 and Th2 T cells, are affected in     individuals with some kinds of cancer -- when the proportion of Th2 cells is greater than Th1     cells, the immune system s ability to fight off the growth of malignant tumors is weakened.     Researchers are interested in determining if an infusion of specially modified Th1 cells, in     addition to stem cell transplant, is a safe and effective treatment for individuals with     forms of multiple myeloma that might not respond well to standard treatments alone.      Objectives:      - To determine the safety and effectiveness of the infusion of modified Th1 white blood     cells, in conjunction with standard treatment, as a treatment for individuals who have been     diagnosed with high-risk forms of multiple myeloma.      Eligibility:      - Individuals age 18 to 75 who have been newly diagnosed with high-risk multiple myeloma and     who have received no or minimal treatment (4 months or less) yet..      Design:        -  Participants will be screened with a medical history, physical examination, blood and          urine tests, and imaging studies. Some participants may also have a bone marrow or other          type biopsy to evaluate the state of their disease.        -  White blood cells will be collected from the participants through an apheresis          procedure, which will collect and separate the white blood cells and return the rest of          the blood to the participant.        -  The collected cells will be grown and expanded under special conditions in the          laboratory and stored frozen until participants receive all the standard of care          treatment for multiple myeloma, including a stem cell transplant.        -  Participants will receive an infusion of the modified Th1 cells a few weeks after the          transplant, and will remain in the hospital for a few days after receiving the cells to          monitor the possible immediate effects of the treatment.        -  Participants will have regular follow-up visits to study the long-term effects of the          modified Th1 cell infusion.   "
156191|NCT01239355|"     This phase II trial is studying how well MK2206 works in treating patients with advanced     liver cancer that did not respond to previous therapy. MK2206 may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
156192|NCT01239342|"     This randomized phase II trial studies the side effects and how well Akt inhibitor MK2206 or     everolimus works in treating patients with kidney cancer that does not respond to treatment.     Akt inhibitor MK2206 and everolimus may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Everolimus may also stop the growth of kidney cancer by     blocking blood flow to the tumor. It is not yet known whether Akt inhibitor MK2206 or     everolimus is more effective in treating kidney cancer.   "
156193|NCT01239329|"     Underweight is more prevalent in people with a mental handicap than in people without a     mental handicap, especially in people with a severe mental handicap. It is unknown if these     people are malnourished. There is no validated screening instrument available to determine     the nutrition status in people with complex multiple disabilities. Research regarding     malnutrition based on body composition and nutrients in stead of anthropometric data is     important.      The aim of the study is to understand the nutritional status of people with complex multiple     disabilitiest through measurement of body composition and nutritients. The primary objective     of the study is: What percentage of people with complex multiple disabilities are     malnourished, based on altered body composition and nutritients? Understanding the     nutritional status of these patients is important in order for them to receive appropriate     and effective treatment. This treatment is of interest for general health and the quality of     daily life.   "
156194|NCT01239316|"     This phase II trial studies how well vismodegib works in treating younger patients with     recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells.   "
156195|NCT01239303|"     During exercise, splanchnic perfusion is compromised, resulting in organ damage in healthy     individuals. Improving the availability of NO might result increase splanchnic perfusion and     prevent organ damage during exercise.   "
156196|NCT01239277|"     Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is     to test whether combined nutrient intake plays an important role in stimulation of the muscle     protein growth in elderly people; and whether it represent effective strategies to overcome     the impaired muscle protein synthesis in elderly when compared with young subjects.   "
156197|NCT01239251|"     The purpose of this study is to test the ease of using a new device, called the GlowCap that     reminds the patient to take their breast cancer hormone pill. The study will collect     information about the experience with this device and what the patient thinks of its role in     the daily pill taking routine.   "
156198|NCT01239238|"     The purpose of the present proposal was to investigate the predictive properties of markers     in exhaled breath to predict an asthma exacerbation. In addition, the reliability of home     monitor assessments to measure asthma control will be examined.   "
156199|NCT01239225|"     Abdominal aortic aneurysms (AAA) are localized, blood-filled dilations (balloon-like bulges)     of the aorta. Approximately 90% of abdominal aortic aneurysms occur infrarenally (1). It is     most commonly asymptomatic and can be detected randomly during screening. Its prevalence rate     in men aged 65 years and more is 5 - 8% (3).      The risk factors for the occurrence of AAA are male gender, advanced age, history of     atherosclerosis, cigarette smoking and 1st degree family history (4).      The prevalence rate is higher in patients with history of atherosclerosis of peripheral blood     vessels and coronary arteries (5 - 7). As the size of an aneurysm increases, there is an     increased risk of rupture, which can result in severe hemorrhage and death. The death rate     due to rupture in the elderly population is 90% (3, 8). Elective surgical repair of the     abdominal aortic aneurysm is associated with a death rate of 8% (9). Therefore, the     importance of the screening of populations at elevated risk is obvious (5 - 7, 10 -14). Among     imaging techniques, ultrasonographic screening for abdominal aortic aneurysm is technically     simple, accurate and devoid of ionizing radiation. Ultrasonographic diagnosis of AAA is     associated with a major reduction in the incidence of abdominal aortic aneurysm-related     mortality (15 - 19). The sensitivity of ultrasonographic screening for abdominal aortic     aneurysm is about 100% (19). The most common clinical indications for ultrasonographic     screening for abdominal aortic aneurysm are a palpable abdominal mass, hemodynamic impairment     of aortic system in lower extremities, pain in the chest, lower back or scrotum, and     abdominal bruits.      Ultrasonography is used to screen for aneurysms when the outer aortic diameter is more than 3     cm (normal diameter of the aorta is around 2 cm (20). There is disagreement regarding the     follow-up of patients after detection of abdominal aortic aneurysm in diameter of 2.6 cm -     2.9 cm (22). Random detection of abdominal aortic aneurysm where the aortic diameter is 2.6     cm, in men aged 65 years and more, have been associated with no risk for its future     significant development (21). Ultrasonographic evaluation of abdominal aorta is a challenge     for clinicians because of the need for the accurate detection of aortic diameter (20).   "
156411|NCT01236456|"     The primary endpoint of this study is to determine what percentage of patients receiving     high-dose Cyclophosphamide may experience a halt in the worsening of their disease or     experience improvement of their disease and for how long the benefit may last.   "
156200|NCT01239212|"     The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg     loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with     seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading     dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady     state drug levels of levetiracetam in neonates.   "
156240|NCT01238692|"     The purpose of the study is to examine both efficacy of LBH589 in treating relapsed and     refractory DLBCL, and added benefit of combining rituximab with LBH589 in this setting.     Tissue samples from accessible lymph nodes will be collected and banked before the start of     the study treatment and after 15 days. Additionally, blood samples will be drawn and stored     in the tissue biobank.   "
156201|NCT01239199|"     Background:      It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide     (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of     family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of     passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators     noticed at the child's a positive relation with the environmental tobacco smoke      Objective: the investigators objective is to bring to light that the rise of the eNO, a non     invasive biomarker of the bronchial inflammation, would be a risk factor expected from     passage of recurrent wheezing of the infant and the young child (of less than 36 months old)     towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing     established, the investigators estimate by questionnaire the severity of the asthma, the     personal and familial atopy, the collection of the environmental data. After allergic     exploration (skin tests and assay of serum total and specific IgE, complete blood count), the     eNO is measured by an off-line tidal breathing method using a chemiluminescence NO analyzer.     Annually, a questionnaire will be send to families to appreciate the persistence or the     remission of the asthma. After a simple descriptive analysis of the population and a     multifactorial descriptive analysis, the investigators shall look for the connections between     the rise of the eNO and the various clinical, biological and environmental parameters known     to influence the variations of this marker. Then the investigators shall select a set of     explanatory variables for a multivariate analysis by a logistic regression step by step.   "
156202|NCT01239186|"     This study will analyse the sperm global methylation status of 62 infertile men before     assisted reproductive techniques. Some of these patients (20%) present hypomethylation of H19     locus. A global methylation analysis may reveal others imprinting defects.   "
156203|NCT01239173|"     Converging lines of evidence have implicated the amygdala in the pathophysiology of     posttraumatic stress disorder.      The primary purpose of our study is to assess the effect of propanolol, a beta adrenergic     antagonism, on amygdala activation during a symptom provocation state in traumatized subjects     with and without posttraumatic stress disorder.   "
156204|NCT01239160|"     The treatment of lymphedema has been a major focus of attention for physicians and scientists     for several decades. At this time, no successful techniques have been developed to prevent     lymphedema, and therefore, a great deal of emphasis is placed on treatment modalities that     can lessen the severity and impede the progression of this debilitating condition.      The treatment on offer usually consists of a maintenance phase using compression garments and     an intensive treatment phase, which includes the use of skin care, compression bandaging,     exercise and manual lymphatic drainage (MLD). The intensive phase is usually described as     complex decongestive therapy (CDT). This is time consuming and requires high resource usage.     Pneumatic compression devices (PCD) offer and alternative to MLD and can be used by the     patient. There are a number of devices on the market that are categorized into 1. without     calibrated gradient compression 2. With calibrated gradient compression.      This trial will compare two PCDs, a simple device without calibrated compression, and an     advanced device with calibrated compression, in the reduction of swelling and maintenance of     reduced limb volume in 262 patients with lower limb lymphoedema. The primary end point will     be limb volume reduction over 12 weeks of treatment, with secondary outcome after 24 weeks.   "
156205|NCT01239147|"     Epidemiological studies suggest that whole grain consumption affects measures of obesity     including BMI, body fat tissue, and body weight. Most cross-sectional studies demonstrate     rather consistently an inverse association between BMI and whole grain consumption.     Furthermore, prospective cohort studies suggest that people with high whole grain consumption     have less risk for body weight gain compared with low whole grain consumption.      The purpose of this study is to assess the effects of inclusion of whole grain in the diet on     anthropometric measures, particularly abdominal fat regain after a weight loss diet.      It is anticipated that the short-term regain of abdominal fat after a weight loss diet is     lower in volunteers consuming whole grain than in volunteers consuming refined grain.   "
156206|NCT01239134|"     TRX518-001 is an open label, non-randomized single group assignment, Phase 1 single dose     escalation study in adults with biopsy proven unresectable Stage III or Stage IV melanoma or     other solid tumor malignancies.      Part A: The study objectives are to determine the safety, tolerability, pharmacokinetic (PK)     and pharmacodynamic (PD) profiles of TRX518 and to define the maximum tolerated dose at which     there are tolerable side effects and/or maximum PK/PD parameter changes.      Subjects will be assigned to a cohort in the order screening is completed. Dose will depend     upon the cohort in which a subject is enrolled and cohorts will be dosed consecutively by     ascending dose. Part A has been completed.      Part B: A Dose-Escalation Study of Multi-dose TRX518 Monotherapy with objectives including     characterization of the safety, tolerability, and pharmacokinetics, as well as, evaluate for     evidence of anti-tumor activity and assess TRX518 immunogenicity.      Part C: An Expansion Cohort of Multi-dose TRX518 Monotherapy at the Maximum Tolerated Dose   "
156207|NCT01239121|"     Medication reconciliation, a process by which a provider obtains and documents a thorough     medication history with specific attention to comparing current and previous medication use,     can prevent medication-related errors and harm. The aims of this study are: 1) To adapt     medication reconciliation to include information from a computerized regional health     information exchange (RHIO) in the Bronx, 2) To conduct a trial of the adapted medication     reconciliation process and examine effects on medication errors, harm, and hospital costs,     and 3) To identify factors that are barriers to adoption of the RHIO tool by James J. Peters     (Bronx) VA providers. Findings from this project will provide an understanding of the effect     of the RHIO tool on reducing harmful VA and non-VA medication use. It will also provide     information on the feasibility of incorporating RHIO tool use into every day work flow for     pharmacists and physicians.   "
156208|NCT01239108|"     Dose escalation study for subjects with Leukemia that has returned or has not responded to     standard treatment.   "
156241|NCT01238679|"     This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a     number of ascending doses administered for 14 days in healthy volunteers.   "
157160|NCT01226615|"     The main purposes of this study are:        -  to determine the effects of chondroitin sulphate on brain response to pain assessed          through fMRI in patients with knee osteoarthritis.        -  to investigate the relationship between treatment response detected by fMRI and the          results of the different parameters of clinical assessment.   "
156209|NCT01239095|"     Colorectal cancer is the third most common form of cancer found in the United States. To date     surgical resection provides the best chance for cure. Unfortunately, despite curative     surgery, tumor recurrences develop in 30-40% of patients from either unforeseen residual     metastases or from viable tumor cells shed into the circulation before or at the time of     surgery. There is evidence from both humans and mice suggesting that tumor growth is     stimulated after surgery for a period of time.      This study calls for the administration of a green tea extract and a milk thistle extract,     two orally ingested supplements, during the week immediately before and weeks after your     surgery. It is not the current standard of care to give anti-cancer drugs during the     perioperative period. The basic idea behind this study is that it should be beneficial to     inhibit cancer growth in the days leading up to and following surgery. Why is this the case?      It makes sense to limit or inhibit tumor growth before surgery with drugs provided it can be     done safely and does not interfere with the surgery. It is also logical to give anti-cancer     drugs after surgery because, unfortunately, about 35 percent of colorectal cancer patients,     after resection, have hidden tumor cells that remain in the body. There is also strong human     evidence that tumor growth is stimulated during the first month after tumor resection as a     result of the surgical injuries and the healing process. Therefore, there is good reason to     give anti-cancer drugs as soon as possible after surgery in order to offset some of surgery's     negative effects.      Although both supplements have been given safely to a wide variety of patients with a number     of different medical problems, the two supplements together have never been given to cancer     patients during the weeks just before and following surgery. We hypothesize that the     administration of these two supplements together will be safe in the period surrounding     colorectal cancer surgery.   "
156210|NCT01239082|"     Colorectal cancer (CRC) is currently the second most common cause of cancer death in the     United States, and one of the most preventable cancers. It has been shown in several     randomized controlled trials that screening using fecal occult blood testing (FOBT) reduces     CRC mortality by 13-33%. While there is strong consensus amongst experts regarding the value     of CRC screening, the best approach to screening is not clear. Of the widely recommended     modalities, FOBT and colonoscopy are the most commonly used within the United States. FOBT is     inexpensive, non-invasive, and its use as a screening tool is supported by the highest     quality evidence (i.e. randomized controlled trials). Moreover, newer FOBT, such as fecal     immunochemical tests or FITs, have advantages over conventional FOBT in terms of both test     characteristics and ease of use that make them quite attractive as a population-based     screening tool.      While colonoscopy is invasive and has higher up-front risks and costs than FOBT, it does     afford the opportunity to directly assess the colonic mucosa and is widely believed to be the     best test to detect colorectal cancer. In addition, colonoscopy allows for the detection and     removal of colorectal adenomas -a well recognized colorectal cancer precursor. There is     indirect evidence that suggests colonoscopy is effective in reducing colorectal cancer     mortality, but to date, no large clinical trials have been completed to support this     assumption. While colonoscopy use is increasing, data is emerging that colonoscopy may not be     as effective as previously believed. Prior support for colonoscopy as a screening test relied     upon effectiveness estimates that now appear to be overly optimistic. Given the invasive     nature of colonoscopy, the associated small, but real risk of complications, and dramatically     higher costs than other screening tests, it is especially important to determine the true     comparative effectiveness of colonoscopy relative to other proven non-invasive options.      The investigators propose to perform a, large, simple, multicenter, randomized, parallel     group trial directly comparing screening colonoscopy with annual FIT screening in average     risk individuals. The hypothesis is that colonoscopy will be superior to FIT in the     prevention of colorectal cancer mortality measured over 10 years. Individuals will be     enrolled if they are currently eligible for CRC screening (e.g. no colonoscopy in the past 10     years and no FOBT in the past 1 year) and are between 50 and 75 years of age. The     investigators will exclude individuals for whom colonoscopy is indicated (e.g. signs or     symptoms of CRC, first degree family member with CRC, personal history of colorectal     neoplasia or inflammatory bowel disease).      All participants will complete baseline demographic, medication, and lifestyle questionnaires     (e.g. diet, non-steroidal anti-inflammatory use, frequency of exercise) prior to     randomization in a 1:1 ratio to either screening colonoscopy or annual FIT screening (Figure     1). Those testing positive by FIT will undergo evaluation to determine appropriateness for     colonoscopy. Screening will be performed in a manner consistent with the currently accepted     standard of care in order to determine the comparative effectiveness of the two screening     strategies. Participants will be surveyed annually to determine if they have undergone     colonoscopy or been diagnosed with CRC.      The primary study endpoint will be CRC mortality within 10 years of enrollment. The secondary     endpoints are (1) the incidence of CRC within 10 years of enrollment and (2) major     complications of colonoscopy. Mortality will be determined through queries of the VA Vital     Status File. Cause of death will be determined primarily using death certificates from the     National Death Index-Plus database, augmented by adjudication of medical records for known     CRC cases where CRC is not listed as a cause of death on the death certificate. The     investigators postulate that screening colonoscopy will result in a 40% reduction in CRC     mortality over 10 years relative to annual FIT screening. Using a log-rank test with a     2-sided test of significance, =0.05, a sample size of 50,000 participants will be required to     test the primary hypothesis with 82% power, assuming a 1% annual rate of crossover from FIT     to colonoscopy and a 0.5% annual rate of loss to follow-up. The planned study duration is     12.5 years with 2.5 years of recruitment and 10 years of follow-up for all enrolled     participants.   "
156211|NCT01239069|"     Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for     the Treatment of Dry Eye Disease   "
156212|NCT01239056|"     The purpose of this study is to study the evaluation of the effectiveness of endoscopic     Pancreatic Pseudocyst drainage using a metal stent.   "
156213|NCT01239043|"     The purpose of this trial is to describe antibody persistence and response to re-vaccination     with either Menactra® or Menomune® vaccine approximately three years following initial     vaccination in adults who participated in trial MTA29 (NCT00874549).      Objectives:        -  To describe the rates of immediate reactions, solicited injection-site and systemic          reactions, all unsolicited adverse events, and serious adverse events following          vaccination.        -  To evaluate persistence of serum bactericidal antibodies in subjects who received          Menactra® or Menomune® vaccine approximately three years ago.        -  To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects          re-vaccinated with either Menactra® or Menomune® vaccine.   "
156214|NCT01239030|"     This multi-center parallel study is designed to study the efficacy and safety of fixed doses     of methylphenidate extended release (ER)capsules of three dose levels compared with a placebo     group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are     between 6 and 18 years old.   "
156215|NCT01239017|"     This is a double-blind, prospective, randomized study in which patients will be randomized to     1 of 5 treatment arms (4 active and 1 placebo).      Each patient will receive one SC injection of REGN475 or placebo and 1 IV infusion of either     REGN475 or placebo, on day 1 (baseline) In order to preserve the blind, patients receiving     REGN475 SC will also receive placebo IV, and patients receiving REGN475 IV will also receive     placebo SC.   "
156216|NCT01239004|"     The present study will assess the low-density lipoprotein cholesterol (LDL-C) lowering effect     of colesevelam as an adjunct to niacin for the improvement of lipids and glycemic control in     dyslipidemic subjects with impaired fasting glucose.   "
156217|NCT01238991|"     The purpose of this long term extension study is to assess safety, tolerability and     immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD     who were randomized in the preceding P2 double blind studies.   "
156218|NCT01238978|"     The study will assess the incidence of Hypoglycemia: Percent of patients presenting no     hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM     patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin   "
156219|NCT01238965|"     Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin calcium, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving panobinostat together with fluorouracil and leucovorin calcium may     kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and the best     dose of giving panobinostat, fluorouracil, and leucovorin calcium together in treating     patients with stage IV colorectal cancer who did not respond to previous fluorouracil-based     chemotherapy.   "
156220|NCT01238952|"     The primary objective is to determine the maximum tolerated dose/recommended phase II dose of     the combination regimen of NK012 and carboplatin in patients with advanced solid tumors.   "
156221|NCT01238939|"     The primary objective is to determine the maximum tolerated dose/recommended phase II dose of     the combination regimen of NK012 and 5-fluorouracil in patients with advanced solid tumors.   "
156222|NCT01238926|"     This experiment seeks to determine whether individuals with PD will benefit from vitamin B6     (pyridoxine hydrochloride), B12 (cyanocobalamin), and Folic Acid supplementation, whether     they will benefit from a 6-week circuit training program, or whether they will benefit from a     combination of the two interventions. The outcome variables will include: plasma     homocysteine, GSH:GSSG ratio, cognitive function, balance, strength, functional activities,     kinematic gait analysis, and a quality of life questionnaire.   "
156223|NCT01238913|"     The evaluation of using metal stents as medically indicated for the treatment of benign     esophageal lesions.   "
156224|NCT01238900|"     The purpose of this study is to study the evaluation of the use of metal stents as part of     the treatment of benign biliary strictures.   "
156239|NCT01238705|"     This randomized,active controlled study aimed to compare the effects on sexual function of     treatment with combined antihypertensive drugs.      The researchers hypothesize that:        1. Both felodipine-irbesartan combination and felodipine-metoprolol combination are          effective in lowing blood pressure in patients with essential hypertension.        2. Felodipine-metoprolol combination induces a worse sexual function and a reduction of sex          hormone,whereas felodipine-irbesartan combination does not impair sexual function and          does not change hormone levels.        3. Oxidative stress decline after both combination regimens. Felodipine-irbesartan          combination has a greater impact on oxidative stress indicators than          felodipine-metoprolol combination.   "
156412|NCT01236443|"     A Study to identify toxicity and optimal photodynamic treatment parameters using the     photosensitizer 2-[1-hydroxyethyl]-2-devinylpyropheophorbide-a (HPPH) in high grade     dysplasia, carcinoma-in-situ, or early adenocarcinoma in Barrett's esophagus.   "
156225|NCT01238887|"     Despite widespread efforts to improve the treatment of obesity, only limited progress has     been made. Calorie restriction (CR) has consistently been shown to produce weight loss, as     well as delay the onset of age-related diseases, in numerous species. Most overweight     individuals, however, are unable to sustain CR induced weight losses, possibly due to     internal feedback systems that signal the body to increase food intake or decrease energy     expenditure in response to weight loss. Novel treatment approaches are thus urgently needed     that can assist overweight individuals in adhering to a CR regimen over the long-term.      Botanicals represent an important and underexplored source of potential new therapies that     may facilitate CR. In particular, one promising botanical that may reduce food intake and     body weight by affecting neuroendocrine pathways related to satiety is Garcinia Cambogia     (Garcinia Cambogia Desr.)-derived (-)-hydroxycitric acid. This compound has been found to     facilitate weight loss in a number of studies. To date, few studies have directly tested the     effect that this botanical on food intake in humans, its mechanism of action, or its effect     on oxidative stress levels; thus rigorous scientific studies on this compounds need to be     conducted. A double-blind, placebo-controlled crossover study will be conducted to explore     the role that two different doses of this botanical compound have on food intake, satiety,     weight loss, and oxidative stress levels. It is hypothesized that compared to placebo, both     doses of Garcinia Cambogia (hydroxycitric acid) will reduce food intake, increase satiety,     decrease weight, and reduce oxidative stress levels.   "
156226|NCT01238874|"     The Latin America CRT Study is a prospective, multicenter, interventional post-market release     study conducted in Latin America. The geography includes Puerto Rico and the Caribbean,     Mexico and Central America, and South America.   "
156227|NCT01238861|"     The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous     administrations of MEDI-563 on adults with uncontrolled asthma.   "
156228|NCT01238848|"     The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline     in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital     stay, oxygen requirements and clinical outcome.   "
156229|NCT01238835|"     A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating     the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; study valve), the next     generation Ascendra™ transapical delivery system, and crimper accessories.   "
156230|NCT01238822|"     Children with Attention Deficit Hyperactivity Disorder (ADHD) have numerous areas of     neuropsychological dysfunction including response inhibition, working memory, and attention.     One neuropsychological outcome measure that consistently reveals between-group differences is     response variability. However, until recently, differences in response variability have been     reported as an ancillary finding or viewed as a nuisance in the analyses. The specific aims     of the present study are to 1) Examine response variability in ADHD patients across     neuropsychological tasks to understand the breadth of this specific deficit and to understand     the relation between response variability and other neuropsychological outcome measures; 2)     Assess whether response variability deficits are specific to either or both of the two most     prevalent ADHD subtypes (i.e., Combined Type [CT] and Predominantly Inattentive Type [PIT]);     3) Determine whether response variability in ADHD patients is affected by either medication     or a variety of environmental manipulations (e.g., reward); and 4) Understand the     relationship between neuropsychological measures of response variability and naturalistic     instances of variable performance. Forty-five children (aged 7-11) with ADHD-CT, 45 children     with ADHD-PIT, and 45 normal controls will be recruited to examine response variability     across a wide range of neuropsychological tests. Task parameters such as event rate, stimulus     saliency, and the presence of operant reward will be modified on each test to determine the     conditions under which response variability is manifested in children with ADHD. In addition,     all children with ADHD will participate in a placebo-controlled, randomized medication trial     with a psychostimulant medication to assess the effects of medication on response     variability. Advanced analytic methods utilizing non-Gaussian distributions and fast Fourier     Transforms of the reaction time data will be used to conduct detailed analyses of RT patterns     across the ADHD and normal control groups. Further, the effects of task parametric     manipulations and medication on response variability will be examined. Finally, relations     between response variability on neuropsychological tests and response variability in a     variety of real-world analog situations will be examined to evaluate the ecological validity     of these deficits.   "
156231|NCT01238809|"     The purpose of this study is to assess in general population low-dose aspirin and     gastroprotective agent compliance and reasons for bad compliance   "
156232|NCT01238796|"     The purpose of this study is to evaluate the effect of renal function on the biological     activity of telavancin using blood samples obtained from subjects with normal renal function,     severe renal impairment, and end stage renal disease.   "
156233|NCT01238783|"     To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for     treatment of bacterial conjunctivitis   "
156234|NCT01238770|"     The current trial shall clarify the potential of the multitarget antiangiogenic tyrosinkinase     inhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as salvage     treatment in patients with recurrent, pretreated ovarian cancer.   "
156235|NCT01238757|"     The purpose of this study is        -  to document the prevalence and type of asynchronies incidence during non-invasive          mechanical ventilation in pediatric patients breathing under pressure support.        -  to observe the impact of adjusting the expiratory trigger setting on asynchronies during          pressure support        -  and compare these incidences with asynchronies measured in pediatric patient breathing          under NAVA system (Neurally Adjusted Ventilatory Assist).   "
156236|NCT01238744|"     The effect of a single dose of flaxseed mucilage incorporated into either drinks or tablets     will be tested in term of their effect on appetite sensation measured using visual analogue     scales over 120 minutes and ad libitum energy intake hereafter in two studies.   "
156237|NCT01238731|"     Background: Persistent severe pulmonary hypertension (PH) after mechanical valve replacement     is a frequent finding in patients with severe valve-diseases. The reasons to develop PH are     multifactorial and the prevalence of severe PH significantly worsens the patients´ outcome.      Aims: (i) To define the prevalence of PH in patients after valve replacement and (ii) to     identify factors predicting persistent PH.      Methods: All patients which underwent valve replacement at our institution between the years     2008 -2010 will be screened retrospectively. Those patients with pre- procedural proven PH by     means of right-heart catheterization will receive prospective follow-up with     echocardiography. Diagnosis of persistent PH will be confirmed with right heart     catheterization.   "
156238|NCT01238718|"     Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation. The     incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be increased     in patients that receive rapid sequence induction and intubation, where opioids are spared     and intravenous anesthetic agents are not titrated step by step. Our hypothesis was that     lidocaine when administered intravenously in patients who undergo rapid sequence induction     may not only blunt the hemodynamic response to intubation, but may also increase the     anesthetic depth (as assessed by BIS), thus further reducing the possibility of hypertension,     arrhythmias and also awareness.   "
156242|NCT01238666|"     This study was designed in two phases: Phase I is designed to confirm that the surgeon is     able to perform accurate liver surface registration including standard liver features used as     landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of     comfort with the procedure.      The surface of the liver will be manually swabbed with the study tracked laparoscopic probe     with landmarks noted during data collection. After registration of the liver is obtained, the     registration points obtained during this procedure will be evaluated by the surgeon by moving     the tracked laparoscopic probe over the liver surface and evaluating the location of the     tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The     surgeon will accept or reject the registration accuracy.      The hypothesis is that the surgeon will be able to successfully acquire liver surface     registrations with a small learning curve for technique and will be able to proceed to Phase     II of the study.      Phase II contains the registration process included above but adds the additional process of     tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder     Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked     and displayed on the Pathfinder three dimensional (3D) image.      The surgeon will use ultrasound (US) guidance to locate tumor location during the     laparoscopic procedure. The images collected during this process will be recorded by     Pathfinder.   "
156243|NCT01238653|"     This study was designed to confirm that the surgeon is able to perform accurate liver surface     registration including standard liver features used as landmarks during a scheduled     laparoscopic liver procedure. The hypothesis is that there will be no clinically relevant     difference between the error measurements obtained during the laparoscopic procedures in this     study when compared with those obtained during previous open liver registration studies.      The surface of the liver will be manually swabbed with the study tracked laparoscopic probe     with landmarks noted during data collection. After registration of the liver is obtained, the     registration points obtained during this procedure will be evaluated by the surgeon by moving     the tracked laparoscopic probe over the liver surface and evaluating the location of the     tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The     surgeon will accept or reject the registration accuracy.   "
156244|NCT01238640|"     The purpose of this study is to assess the bioequivalence between two new oral nicotine     replacement therapy products and Nicorette® microtab.   "
156245|NCT01238627|"     The purpose of this study is to assess the bioequivalence between two oral nicotine     sublingual tablets, 2 mg and 4 mg.   "
156246|NCT01238614|"     The CHICA system is a clinical decision support system that uses adaptive turnaround     documents to provide point-of-care information to clinicians. We will be studying whether it     can help in the diagnosis and referral of mothers with maternal depression.   "
156247|NCT01238601|"     The purpose of this study is to determine how different types of breast implants contour to     the chest wall.   "
156248|NCT01238588|"     The hypothesis is that switching calcium based phosphate binders to sevelamer carbonate will     be associated with less inflammation including less atherosclerotic plaque inflammation     (inflammation of the vessel walls).   "
156249|NCT01238575|"     The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself     or in combination with methylphenidate (also known as Ritalin) is helpful for treating     hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).   "
156250|NCT01238562|"     This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a     single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish     dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).   "
156251|NCT01238549|"     The field of spinal cord injury (SCI) rehabilitation medicine lacks a reliable, patient     reported, health-related quality of life measurement tool. The National Institute of Health     has provided funding to develop a SCI-specific, quality of life (QOL) survey tool in     non-Veterans with SCI called the SCI-QOL. This quality of life survey asks questions     regarding physical/medical, emotional, and social health as it relates to individuals with     spinal cord injury.      The purpose of this study is to include a Veteran population in the making of the quality of     life survey. Each participant will be asked to complete a packet of quality of life     questions. Participants will be given the opportunity to take the survey a second time,     either 7-14 days or 5-7 months after the first survey. Taking the survey twice will allow the     research team to test the reliability of the survey. Comparing the SCI-QOL with other legacy     measures will allow the investigators to test the validity of the survey.      Additionally, the investigators will be testing the SCI-QOL between Veterans and non-Veterans     with SCI to determine if there are differences in their self-reported quality of life.      This study will be recruiting participants at the James J. Peters Veterans Affairs Medical     Center (VAMC) in Bronx, New York and the James A. Haley Veterans Affairs (VA) Hospital in     Tampa, Florida. The James J. Peters VAMC will be recruiting 125 participants and the James A.     Haley VAH will be recruiting 275.   "
156252|NCT01238536|"     The broad, long-term objective of this research protocol is to improve the quality of life     for patients suffering from lumbar spinal stenosis. This objective will be met by examining     the safety and clinical efficacy of epidural steroid injections for treatment of pain     associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled     trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections     (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older     adults with lumbar spinal stenosis.   "
156413|NCT01236430|"     The intent of this study is to demonstrate that single doses of the Final Market Image (FMI)     ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are     bioequivalent to the same doses of ezetimibe (ZETIA®) and atorvastatin (LIPITOR®) that are     coadministered as individual tablets in healthy adults.   "
156292|NCT01238003|"     Laboratory testing of Anti-Neutrophil Cytoplasm Antibody (ANCA) is used to confirm diagnosis     of patients who have a high level of suspicion for ANCA-related vasculitis. In these patients     the specificity and sensitivity to the ANCA test is very high. This study hopes to prove that     when this lab test is performed on blood of patients who do not have a high level of     suspicion for ANCA-related vasculitis, the sensitivity and specificity is reduced and there     are many false positive results. Because of this, it should not be used as a screening test     for a more general patient population.   "
156253|NCT01238523|"     Tibial shaft fracture is one of the most common fractures in children and adolescents. It     encompasses approximately 15 % of all long-bone fractures and is third behind only fractures     of the femur and both bones of the forearm. (2). Although most authorities agree that closed     tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no     clear consensus as to when to allow weight bearing on the injured extremity. While most     recent articles have recommended long-leg casts with the knee bent in flexion of 30-60     degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less     flexion, 0-5 degrees, to encourage early weight bearing.(5).      The purpose of this randomized controlled prospective study is to determine if the position     of immobilization of the knee influences the rate of healing, delayed union, and nonunion As     well, we will assess if the type of immobilization affects the function of the patient during     the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child     self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a     total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the     tibia, with or without fracture of the fibula, will be included in the study   "
156254|NCT01238510|"     In the setting of single stent strategy for treatment of bifurcation, we investigate to     compare simple strategy as provisional final kissing balloon technique(fKBT) to complex one     as routine FKBT, focusing on actual myocardial ischemia assessed by scintigraphy in 7-month     and to examine optimal endpoint of side branch ostium.   "
156255|NCT01238497|"     This registry is to expand upon existing data sets, to identify patient characteristics and     indicators related to complications and clinical benefits for patients with symptomatic     severe calcific degenerative aortic stenosis that are undergoing treatment with the     commercially available Edwards SAPIEN XT™ Valve, and delivery devices.   "
156256|NCT01238484|"     The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is     effective in treating contracture for patients with Ankle Equinus secondary to diabetes     mellitus.   "
156257|NCT01238471|"     In premature infants, propranolol (Prop) treatment might suppress continuing     neo-vascularization (NV) and decelerate the progression of retinopathy of prematurity (ROP)     towards its severe stages (III-V), thus avoiding the need of interventions (CRYO and/or LASER     photo-coagulation of the ischemic retina and preventing severe ocular sequelae. We therefore     plan to prospectively investigate the influence of prop versus placebo in VLBW infants with     ROP stage 1 (zone I), with stage 2 or higher (any zone) or with Plus disease, along with     close follow up regarding safety of prop administration and its effect on ROP.   "
156258|NCT01238458|"     This study will recruit a total of 150 evaluable subjects (30 cognitively normal volunteers,     and 60 MCI(Mild cognitive impairment), and 60 AD(Alzheimer's disease), respectively) Each     evaluable subject involved in this study must fulfill all the inclusion and exclusion     criteria according the subject grouping.      Safety measurement will be evaluated by medical history, vital signs, physical examinations,     laboratory examinations and collecting of adverse events.      This study is expected to be completed in a period of 3 years.   "
156259|NCT01238445|"     Bronchiolitis is a significant cause of morbidity and hospitalizations in children,     accounting for more than 125,000 hospitalized children per year in the United States.     Although treatment is largely supportive, bronchodilator medications such as albuterol are     frequently used due to increased pulmonary resistance in this population.2-4 However, despite     four decades of clinical trials, the efficacy of albuterol in the treatment of bronchiolitis     has yet to be proven. This inconsistency is due in part to the lack of sufficiently sensitive     methods for the evaluation of lung function and thus the response to albuterol in infants.     Because of the difficulties in evaluating the response to therapy, healthcare providers are     forced to rely on their physical examination skills or a clinical scoring system, both of     which are highly subjective in this population. The investigators propose to conduct a     prospective observational study of healthcare providers to determine the accuracy of clinical     assessment as compared to that of pulmonary mechanics in a population of children intubated     and mechanically ventilated for bronchiolitis.   "
156260|NCT01238432|"     Near fatal asthma exacerbations are one of the most common causes of critical illness in     children, accounting for approximately ten thousand intensive care unit (ICU) admissions per     year in the United States. Even children with intermittent or mild baseline asthma can     develop these severe exacerbations; however, there are few studies evaluating the risk     factors associated with the development of near fatal asthma exacerbations in children.     Inhaled β2-adrenergic receptor (ADRβ2) agonist therapy is the foundation of therapy for acute     asthma and genetic variations of this receptor have been shown to affect response to ADRβ2     agonist therapy in this population. The investigators hypothesis is that a child's ADRβ2     genotype is associated with the development of a near fatal asthma exacerbation.   "
156261|NCT01238419|"     The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison     with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg     ulcer.   "
156275|NCT01238237|"     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. Initial     therapy consists of either surgical resection, external beam radiation or both. All patients     experience a recurrence after first-line therapy, so improvements in both first-line and     salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is     unknown if currently used intravenous (IV) therapies even cross the blood brain barrier     (BBB). Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can     effectively increase the concentration of drug delivered to the brain while sparing the body     of systemic side effects. One currently used drug called, Cetuximab (Erbitux) has been shown     to be active in human brain tumors but its actual CNS penetration is unknown. This phase I     clinical research trial will test the hypothesis that Cetuximab can be safely used by direct     intracranial superselective intraarterial infusion up to a dose of 500mg/m2 to ultimately     enhance survival of patients with relapsed/refractory GBM/AA. By achieving the aims of this     study the investigators will determine the the toxicity profile and maximum tolerated dose     (MTD) of SIACI Cetuximab. The investigators expect that this study will provide important     information regarding the utility of SIACI Cetuximab therapy for malignant glioma, and may     alter the way these drugs are delivered to the investigators patients in the near future.   "
156262|NCT01238406|"     Study design: Multicenter,randomized, prospective, open label, cross over, six segments,     pilot trial to evaluate blood glucose control overnight under closed-loop insulin delivery     with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes.      on the first segment 15 eligible subjects will be enrolled from the three participating     centers (5 patients at each center). All 15 patients will participate in the overnight closed     loop session in the hospital settings.      On the second segment, 54 eligible subjects will be enrolled (18 at each center). Each     subject will participate in the two consecutive overnight sessions in diabetes camp settings,     one under closed-loop with MDLAP and one under sensor augmented pump therapy.      In the third segment,9-20 eligible patients will be enrolled at the Israeli center only.Each     subject will participate in up to four consecutive overnight under closed loop with MDLAP and     up to four additional overnight under regular sensor augmented pump therapy at home.      On the fourth segment, 45-60 patients will be enrolled at the Israeli center only. This     segment will be conducted at a diabetes camp and will consist of two main parts. In part 1,     15-20 patients will be randomized to participate in one of the two groups: 2-4 nights under     closed loop control while the MD-Logic learning algorithm is activated or 2-4 nights under     closed loop control without activating the MD-Logic learning algorithm. In part 2 of the     forth segment 30-40 patients will participate in two consecutive24-48 hours sessions,one     under closed loop control and the second under sensor augmented pump therapy.      On the fifth segment 40-80 eligible patients will be enrolled at the Israeli center only.The     first 10 patients will participate in a pilot session and data gathered at this pilot session     will not be used at the final analysis.This segment will consist of two parts. At part 1 each     subject will participate in 4weeks-1.5 months period of over nights either using closed-loop     with MDLAP or using sensor augmented pump (SAP) therapy.At the end of the first 4 weeks-1.5     months of the study, statistical analysis will be performed in order to decide whether to     extend the study with an optional period of extra 4 weeks-1.5 months.In case it will be     decided to extend the study, additional 4 weeks-1.5 months intervention period following     completion of final visit activities will be offered to participants. Subjects that have     participated in the control group (sensor augmented pump therapy) will be offered the     opportunity to continue to 4 weeks-1.5 months of closed-loop control and the study group will     be offered to switch to sensor augmented pump therapy. In segment 5 part 2, up to 40 patients     will be enrolled. Each patient will participate in 3 months study period either using     overnight closed loop under MDLAP or sensor augmented pump therapy.Participants in segment 5     part 2 will be offered to participate in part 2A. At this part, sleep quality assessment will     be made (by using actigraf and sleep questionnaire) At the end of this period an optional 3     months extension period will be offered with the other arm (cross-over)      Segment 6 will be consist of two main parts.In part 1, up to 40 eligible patients will be     enrolled at the Israeli center only. Each subject will participate in up to 72 hours of     closed-loop with MDLAP at home and up to 72 hours under regular sensor augmented pump therapy     . The sequence of the treatment intervention will be randomly assigned. The sequence of the     treatment intervention will be randomly assigned. In part 2 of this segment 40 eligible     patients will enrolled at the Israeli center only. Each subject will participate in up to 2     weeks of closed loop with MDLAP at home and up to 2 weeks under regular sensor augmented pump     therapy. The sequence of the treatment intervention will be randomly assigned      Objectives: The objective of this feasibility study is to evaluate the safety and efficacy of     blood glucose control using the MD-Logic Artificial Pancreas System in individuals with type     1 diabetes in the hospital settings,at a diabetes camp and finally at patient's home.   "
156263|NCT01238393|"     The purpose of this study is to determine whether intraocular injection of ranibizumab     decreases the retinal thickness in patients with epiretinal membranes and reduces associated     symptoms.   "
156264|NCT01238380|"     Monogenic diabetes is an unusual form of diabetes. It usually presents in patients under the     age of 30, so is often misdiagnosed as Type 1 diabetes which is more common. Patients with     monogenic diabetes can often be treated with tablets rather than insulin injections, leading     to better control of their diabetes, and fewer side-effects and complications. Less than 5%     of people with monogenic diabetes in the UK have been identified, meaning up to 20,000     patients may still be misdiagnosed and receiving inappropriate treatment. We want to identify     the best way of ensuring that people diagnosed with diabetes under the age of 30 have all the     necessary tests to ensure they have the correct treatment for their particular type of     diabetes. A small number of people may, as part of this study, be found to have a specific     genetic cause of their diabetes and in these cases we will measure the success and benefits     of changing their treatment, usually from insulin injections to sulphonylurea tablets.   "
156265|NCT01238367|"     This trial is conducted in Japan. The aim of this clinical trial is to investigate the     pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog     alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.   "
156266|NCT01238354|"     This study focuses on the difficulties to maintain a weight loss and behavioural change after     having been in a institutional intermittent weight loss programme.      We explore if including a member of the family or a close friend in the treatment influences     weight loss maintenance after completion of the programme.   "
156267|NCT01238341|"     In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an     endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).   "
156268|NCT01238328|"     The purpose of this study is to evaluate the efficacy and side effects of donor hematopoietic     cells using chemotherapy regimen without total-body irradiation in children undergoing a     hematopoietic stem cell transplant for Mucopolysaccharidosis. The blood stem cells will be     derived from either related donor or unrelated umbilical cord blood or haploidentical donor.   "
156269|NCT01238315|"     The purpose of this Phase Ib study is to determine if Human Central Nervous System Stem     Cells(HuCNS-SC) is safe to be transplanted in subjects with infantile and late infantile     neuronal ceroid lipofuscinosis. The study will also measure post-transplantation disease     progression.   "
156270|NCT01238302|"     -  The purpose of this study is to compare the clinical and anatomical outcomes of rotator          cuff repair with Platelet-Rich Plasma(PRP) and conventional rotator cuff repair in          treatment of large to massive rotator cuff tears.        -  PRP application to arthroscopic rotator cuff repair would accelerate recovery after          arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall          satisfaction, and enhance structural integrity of repaired tendon.   "
156271|NCT01238289|"     The purpose of this study is to evaluate the effect of a culturally sensitive diabetes     self-management program on glucose control and metabolic parameters in low income     Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost,     peer-educator format.   "
156272|NCT01238276|"     This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft     tissue infections. In this study, cefazolin is delivered directly to the target tissues using     subcutaneous injection of antibiotic solution and then dispersed using high-frequency     external ultrasound. Using this system, a much higher concentration of antibiotic can be     achieved than through traditional treatment methods.      Unlike traditional delivery methods, Direct Antibiotic Delivery does not rely on blood supply     and is beneficial for subjects with Diabetes or subjects who have received radiation therapy     and blood supply is limited.   "
156273|NCT01238263|"     Recently, IgE-type autoantibodies against self proteins have been detected in the serum of     the atopic dermatitis patients. The role of this IgE autoantibodies involved in the     pathogenesis of atopic dermatitis is not known, yet. But, there may be a correlation between     the severity of the disease and the serum levels of this autoantibodies. The autologous serum     skin testing is applied to both atopic dermatitis patients and healthy control and the     results are estimated in this study.The investigators detected 70% positive autologous serum     skin testing in atopic dermatitis patients and test positivity was higher in patients with     atopy history, moderately severe disease calculated by SCORAD index and high serum IgE     levels.   "
156274|NCT01238250|"     The Simons Variation in Individuals Project (VIP) is characterizing the medical, behavioral,     and learning features of individuals with specific documented genetic changes associated with     features of autism and developmental delay with the goal of improving clinical care and     treatment for these individuals.   "
156414|NCT01236417|"     This is a pilot study of a specifically designed exercise intervention developed for breast     cancer patients with aromatase-inhibitor related joint pain.   "
156276|NCT01238224|"     An increase of blood flow and capillary permeability decrease the impact of an endothelial     barrier for glucose and insulin allowing them to reach their target cells in peripheral     insulin sensitive organ in the human body. It is well known that insulin-resistant type 2     diabetes patients have an impaired blood flow in skeletal muscle and it is therefore     important to elucidate means to reverse this metabolic defect.      The investigators have in a recently published study in type 2 diabetes patients used a drug     against erectile dysfunction, the PDE-5 inhibitor tadalafil, with known effects on several     vascular territories, to increase muscle blood flow in type 2 diabetes patients who were     studied after fasting overnight.      The aim of this study is to test the hypothesis that tadalafil, compared to placebo,     increases muscle glucose uptake and lowers blood glucose following a mixed meal served to     type 2 diabetes patients.   "
156277|NCT01238211|"     This phase II trial studies the side effects and how well giving combination chemotherapy     together with dasatinib works in treating patients with newly diagnosed acute myeloid     leukemia. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Dasatinib may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth. Giving combination chemotherapy together with     dasatinib may kill more cancer cells.   "
156278|NCT01238185|"     RATIONALE: Aspirin mouthwash may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of aspirin mouthwash     in treating patients with oral leukoplakia.   "
156279|NCT01238172|"     RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients     with prostate cancer.      PURPOSE: This randomized clinical trial is studying how well diet works in altering disease     progression in patients with prostate cancer on active surveillance.   "
156280|NCT01238159|"     The purpose of this study is to evaluate the efficacy of concomitant chemoradiation followed     by MIDLE chemotherapy for stage I/II extranodal NK/T cell lymphoma.   "
156281|NCT01238146|"     This phase I/II trial is studying the side effects and the best dose of obatoclax mesylate     when given together with rituximab and bendamustine hydrochloride to see how well it works     compared with rituximab and bendamustine hydrochloride alone in treating patients with     relapsed or refractory non-Hodgkin lymphoma. Obatoclax mesylate may stop the growth of cancer     cells by blocking some of the proteins needed for cell growth. Monoclonal antibodies, such as     rituximab, can block cancer growth in different ways. Some find cancer cells and help kill     them or carry cancer-killing substances to them. Others interfere with the ability of cancer     cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride,     also work in different ways to stop the growth of cancer cells, either by killing the cells     or by stopping them from dividing. Giving obatoclax mesylate together with rituximab and     bendamustine hydrochloride may kill more cancer cells   "
156282|NCT01238133|"     This phase I trial studies the side effects and the best dose of gamma-secretase inhibitor     RO4929097 when given together with paclitaxel and carboplatin in patients with stage II or     stage III triple-negative breast cancer. Gamma-secretase inhibitor RO4929097 may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs use in     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Giving gamma-secretase inhibitor RO4929097 together with paclitaxel and     carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed.   "
156283|NCT01238120|"     A combination of low-does ibuprofen along with a structured home-based walking and     progressive resistance exercise program, EXCAP, will be effective in reducing cognitive     difficulties among cancer patients receiving chemotherapy.   "
156284|NCT01238107|"     A phase II clinical study to evaluate MT-102 administered over a sixteen week period in     subjects with cachexia related to non-small cell lung cancer and colorectal cancer   "
156285|NCT01238094|"     The purpose of this study is to compare 2nd line XELIRI/FOLFIRI + simvastatin vs     XELIRI/FOLFIRI + placebo.   "
156286|NCT01238081|"     Respiratory viruses, such as those that cause colds and influenza, are very common in the     general population. The average adult will experience between 2 and 4 viral respiratory     illnesses each year. It is known that respiratory viruses can cause flare-ups of chronic lung     diseases such as asthma and chronic obstructive pulmonary disease. In children with CF,     respiratory viral infections have been identified in nearly half of all exacerbations and are     associated with a decline in lung function and increased frequency of hospital admission and     acquisition of new bacterial pathogens.      Currently, little is known about the impact of viral infections on the course of CF lung     disease in adults and no large-scale prospective studies in this area have been performed to     date. It is unknown how often respiratory viruses can be found in patients with CF when they     are well and what consequences they have on the course of exacerbations of CF lung disease.     This study will identify the frequency of common viral infections in adults with CF and     determine the effects they have on lung function, the rate and diversity of bacterial     infection and patients' treatment burden. The information gained from this study will lead to     improved prevention and treatment of respiratory infections in CF.   "
156287|NCT01238068|"     The study hypothesis is the the results of the use of Gamma nail will be superior to the use     of Dynamic hip screw for unstable intertrochantric hip fracture.   "
156288|NCT01238055|"     The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in the     treatment of advanced gastric cancer patients who had prior chemotherapy with     fluoropyrimidine and platinum.   "
156289|NCT01238042|"     Patient's with High Grade Dysplasia, Carcinoma in situ or Early Adenocarcinoma in Barrett's     Esophagus are injected with HPPH and one day later are endoscopically treated with light from     a laser.   "
156290|NCT01238029|"     The purpose of the study is to investigate safety and efficiency of the triple combination of     capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.   "
156291|NCT01238016|"     The trial aims at measuring the safety and performance of the Hyposafe device.   "
179151|NCT00180024|"     The hypothesis is tested that stimulation with angiotensin II after blockade of the     AT1-receptor results in venodilation in human healthy subjects in vivo.   "
156293|NCT01237990|"     This study was designed to confirm that the surgeon is able to perform surface registration     of standard liver features used as landmarks during a scheduled laparoscopic liver procedure.     Additionally, registrations will be obtained with full insufflation pressure and with half     insufflation pressure during the laparoscopic procedure. Under the presence of both     insufflation pressures, the surface of the liver will be manually swabbed with the study     tracked laparoscopic probe with landmarks noted during data collection. After registration of     the liver is obtained, the registration points obtained during this procedure will be     evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and     evaluating the location of the tracked laparoscopic probe displayed on the guidance system 3D     image. The surgeon will accept or reject the registration accuracy. Upon completion of the     scheduled laparoscopic procedure, the subject will then undergo the open procedure scheduled     for the surgical case. An open liver registration will be obtained with manual swabbing of     the liver using the study tracked probe and will be accepted or rejected by the surgeon using     the process described in the laparoscopic procedure.      In the event that the disease is determined to be too great for surgical repair during the     laparoscopic staging procedure, only minimally invasive liver surface data will be acquired     and the patient will not be included in the overall study population.   "
156294|NCT01237977|"     The purpose of this study is to test the hypothesis that the efficacy and safety of     Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.   "
156295|NCT01237964|"     A pilot experiment to test the efficiency of the enzyme Collagenase in treating contractures     which result's from burn's healing process.      So far, treatment of choice in patients with burn's created movement limiting contractures,     concentrated around supportive care. Patients were referred to surgical intervention only if     necessary. Treatment by injecting an external enzyme is avant-garde and hasn't been done     under such conditions.      This study might introduce a new kind of treatment, which can be done in ambulatory     environment .This type of treatment might significantly improve patients' function and     quality of life, with no need for a surgical intervention.   "
156296|NCT01237951|"     The goal of this clinical research study is to learn if the combination of gemcitabine,     busulfan, and melphalan, when given before a stem cell transplant, can help to control     refractory myeloma. The safety of this study treatment will also be studied.   "
156297|NCT01237938|"     This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to     reduce mammographic density in women at high risk for breast cancer.   "
156298|NCT01237925|"     Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema,     itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine     formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus,     including the ones caused by sunburn. The aim of the present study is to demonstrate     non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel)     with the standard preparation (1% cream) for the relief of sunburn related symptoms and to     demonstrate the safety of both preparations.   "
156299|NCT01237912|"     The current study was designed to determine the exposure of adult smokers and non-smokers to     cigarette smoke constituents through evaluation of selected biomarkers of exposure.   "
156300|NCT01237899|"     The purpose of this study is to investigate the safety and tolerability of LY2623091 after     multiple oral dosing in healthy men and women of non-childbearing potential. Two cohorts of     16 subjects will participate in 2 dosing periods. Treatment assignment will be double-blind     for LY2623091 and placebo(negative control), and open label for eplerenone(positive control).   "
156301|NCT01237886|"     Knowing when to liberate patients from mechanical ventilation (i.e. removal of breathing or     endotracheal tube or extubation) is critically important, as both prolonged ventilation and     failed extubation are both associated with harm and risk of death. Our objective is to     improve the safety of extubation by harnessing hidden information contained in the patterns     of variation of heart and respiratory rate measured over intervals-in-time. Currently, to     assess a patient's ability to be extubated, a spontaneous breathing trial (SBT) is routinely     performed, where the level of ventilator support is reduced, and their response is observed     in order to help predict if they will tolerate extubation (i.e. complete removal of     ventilator support). Given that health is associated with a high degree of variation of     physiologic parameters (e.g. heart and respiratory rate), and illness & stress are associated     with a loss of variability, the investigators aim to uncover the loss of variation as a     measure of stress during SBT's. The investigators hypothesize that maintaining stable heart     rate and respiratory rate variability (HRV and RRV) throughout the SBT will predict     subsequent successful extubation, and conversely, a reduction in either HRV or RRV manifest     during a SBT predicts extubation failure. A pilot study has demonstrated feasibility, and     compelling preliminary results. A website, centralized data storage and analysis, and a     trans-disciplinary team of scientists are in place to definitively test this novel     technology. Determination of when to extubate critically ill patients remains a high-stakes     clinical challenge; and improved prediction of extubation failure has potential to save lives     and reduce costs in critically ill patients.   "
156302|NCT01237873|"     The purpose of this study is to evaluate the long-term safety and tolerability of the     combination of aliskiren and amlodipine given to patients with essential hypertension. This     study is being conducted to support registration of the fixed combination of     aliskiren/amlodipine in the treatment for hypertension in Japan.   "
156303|NCT01237860|"     The study is designed to evaluate the safety and efficacy of using the L300 Plus as a     neuroprosthesis device for walking in patients following an UMN injury or disease. The     clinical study is proposed to determine the anticipated adverse event rate and treatment     outcomes at the conclusion of the study.   "
156325|NCT01237574|"     Chronic alcoholic and metabolic liver diseases are the two main liver diseases in France. The     long-term prognosis of these two diseases are not well known because main studies are     retrospective and with only alcoholic patients. The knowledge of the natural history of these     diseases should improve the management of patients with such diseases.      The aim of this prospective cohort is to describe the natural history of patients with     chronic liver disease due to alcohol or metabolic disease and to identify factors associated     with complications of these liver diseases (cirrhosis, hepatocellular carcinoma, ascites.     ..).   "
156304|NCT01237847|"     This project will test if a phone intervention can improve the medicine-taking behavior of     teens with IBD. The investigators will study teens who are taking medicine by mouth. The     investigators will test if two phone calls that help teens solve problems with their IBD     medicine help to increase how often teens take their medicine. The study will also see if     there is any extra benefit of more sessions (four compared to two). The investigators will     ask 90 teens to be in the study. Teens can be in the study if they are 11-18 years old and     speak English. They must also take an IBD medication by mouth and have a parent who also     wants to be in the study. Teens who agree to be in the study will fill out forms at the     beginning (participant week 0), middle (participant week 12), and end of the study     (participant week 20). After assessment 1, they will be randomly assigned to either receive 2     phone calls or a wait list group (participant weeks 6-10). After that, they will complete a     second assessment. After the second assessment, teens who got the 2 phone calls right will be     re-randomized to two more sessions or no more sessions (participant weeks 14-18). Teens who     were in the wait list group will get two phone sessions (participant weeks 14-18). After     that, there will be a final assessment (participant week 20). The investigators expect the     phone intervention sessions to reduce barriers to medicine taking, improve medicine taking,     and improve teen quality of life.   "
156305|NCT01237834|"     This study will analyze a series of biological and behavioral markers in different     populations of smokers. The study groups will differ in their cigarette consumption and level     of nicotine dependence. This analysis will help to identify factors that might be important     for smoking behavior and nicotine addiction. The results from this study will contribute to     improve campaigns for smoking prevention and treatments for smoking cessation.   "
156306|NCT01237821|"     This research is being done to find out the safety and efficacy of two acne creams, Effaclar     and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA     approved for the treatment of acne.   "
156307|NCT01237808|"     This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients     with AML and NPM1 mutation ineligible for intensive chemotherapy.      Sample size: 144 patients      Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are     expected to be included into the trial)      Estimated treatment duration of an individual patient: 8 months (Follow-Up period per patient     will last additional 2 years)   "
156308|NCT01237795|"     This trial aims to evaluate the efficacy of three experimental dentifrices to remove denture     biofilm. Complete denture wearers will be instructed to brush their dentures with a specific     toothbrush and four compositions: (1) A proprietary denture-specific paste (active     comparator); (2) 0.2% chloramine T; (3) 1.0% chloramine T; (4) 0.01% fluorosurfactant. Each     treatment will be used for periods of 7 days, and participants will be randomized to use them     according to one of four sequences.   "
156309|NCT01237782|"     The purpose of this study is to assess if a propolis solution is able to remove plaque and     kill microbes from complete dentures. The investigators will compare the results of the     propolis-based denture cleanser with those obtained with an inactive solution.   "
156310|NCT01237769|"     In recent years emphasis has been given to investigate the role of vitamin D in areas beyond     bone metabolism and maintenance of calcium homeostasis. Thus, vitamin D deficiency has been     associated with risk factors for the occurrence of cardiovascular disease as well as with     overall mortality.In addition, there are indications that a large proportion of the     population (up to 50%) is vitamin D deficient. The measurement of vitamin 25 (OH) D3 levels     is the best way to estimate the vitamin D actual reserves. It is worth mentioning that     elevated levels of parathyroid hormone (PTH) [5] and reduced levels of 1,25 (OH)2 vitamin D3     (calcitriol have also been associated with cardiovascular disease.      The metabolic syndrome is a sum of risk factors for cardiovascular disease and is found in     approximately 25% of the Greek population.There are a lot of data linking low vitamin D     levels with the metabolic syndrome as a whole as well as with its individual characteristics.     Specifically, vitamin D deficiency has been associated with increased incidence of     hypertension, dyslipidemia, obesity, inflammation and dysglycemia.      Many studies have explored the effect of giving vitamin D supplements on the risk factors     associated with the metabolic syndrome and the cardiovascular disease. The results of these     studies are conflicting and this may partially be due to different doses of vitamin D used.     The form of vitamin D most commonly used in these studies is cholecalciferol (vitamin D3.      Aim of the study:      Determination of the effect of cholecalciferol (VitD3) (2200 IU/day) on metabolic parameters     in patients with metabolic syndrome.      Endpoints:      The primary endpoint will be changes in metabolic syndrome parameters 3 months after starting     treatment:        -  Waist circumference        -  Blood pressure        -  Levels of fasting serum triglycerides        -  Levels of high-density lipoprotein cholesterol (HDL-C)        -  Levels of fasting serum glucose.      The secondary endpoints will include changes in:        -  The levels of low-density lipoprotein cholesterol (LDL-C) and non-HDL-C        -  Subfractions of LDL-C [average particle size of LDL-C, levels of small dense (sd) LDL-C]        -  Subfractions of HDL-C (levels of small and large particle HDL-C)        -  The activity and levels of Lp-PLA2 (lipoprotein-associated phospholipase A2)        -  The levels of serum apolipoprotein AI, A-II, AV, B, E, C-II, C-III and lipoprotein (Lp)          (a)        -  The activity of paraoxonase-1 (PON1)        -  The concentration of pre-beta1-HDL        -  The levels of hs-CRP (high sensitivity C-reactive protein)        -  Oxidative stress as measured by levels of 8-isoprostane in the blood and urine and          oxidized LDL (oxLDL)        -  Adipokine levels (leptin, adiponectin, visfatin)        -  Glucose homeostasis (index HOMA: fasting insulin X fasting glucose/405)        -  The levels of glycosylated hemoglobin (HbA1c)        -  The levels of 25 (OH) vitamin D3, of 1,25 (OH)2 vitamin D3 and PTH        -  The levels of serum electrolytes (Ca, PO4) and the activity of alkaline phosphatase          (ALP) in serum.      Study population:      The investigators will study patients with metabolic syndrome (n = 50 adults) attending the     Outpatient Lipid and Obesity clinic at the University Hospital of Ioannina. Diagnosis of the     Metabolic Syndrome will be based on the criteria of National Cholesterol Education Program     Adult Treatment Panel III (NCEP-ATP III).      All patients will be instructed to exercise and lose weight according to the NCEP-ATP III     diet. The participants will be randomized in an open manner into one of the following 2     treatment groups: a) cholecalciferol (VitD3) (2200 IU/day) plus lifestyle measures or b) only     lifestyle measures. Recruitment will be completed within one year. The reassessment of the     patients will be done 3 months after starting of treatment.   "
156311|NCT01237756|"     Endobronchial tube misplacement is serious complication during general anesthesia in     pediatric patients. Correct placement of the endotracheal tube (ETT) in the trachea is     crucial. Several methods have been suggested for determination of correct ETT placement.     However, to date, auscultation of the left and right lung is the standard of care and the     only ubiquitary available method with an error rate of up to 12%. Electrical impedance     tomography (EIT) is a new non-invasive method for evaluation of left and right lung     ventilation. In this study the investigators investigate the potential role of EIT for proper     placement of pediatric endotracheal tubes.   "
156312|NCT01237743|"     Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for     definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate.     By avoiding the effects of cardiopulmonary bypass on cerebral hemodynamics and microembolic     load, TAVI is assumed to be beneficial regarding risk for neurological complications. We     anticipated that the extensive endovascular retrograde manipulation in ascending aorta and     aortic root would generate a detectable cerebral microembolic load, and thus an increase in     serological markers of neuronal injury postoperatively. Our hypothesis is that there is a     positive correlation between the total amount of cerebral microembolic events during the TAVI     procedure and the Area under curve (AUC24hrs) for the release pattern of two markers of     neuronal injury. We also wish to describe the extent and distribution of microembolisms     during the TAVI procedure using Transcranial Doppler (TCD).   "
156313|NCT01237730|"     Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce     the peristomal infection rate   "
156314|NCT01237717|"     One interesting area is the relationship of high salt intake and central aortic blood     pressure. High salt intake is associated development of hypertension and cardiovascular     mortality. Central aortic pressure is better correlated with cardiovascular events and     mortality. With recent advances in technology, it is possible to measure central aortic     pressure noninvasively and easily. Until now there is no study to evaluate the relationship     of high salt intake and aortic blood pressure.      The purpose of the present study is to evaluate the relationship of high salt intake and     aortic blood pressure and aortic stiffness.      Subjects with or without hypertension will be enrolled for investigation. Subjects with     hypertension should be never treated with antihypertensive medications. Subjects with     secondary hypertension, diabetes, heart failure, high grade kidney disease, ischemic heart     disease, and major arrhythmia will be excluded.      Sodium intake is measured by 24 hour urinary sodium excretion, with the measurement of     peripheral and central aortic blood pressure, and aortic pulse wave velocity.      Salt sensitive hypertension related single nucleotide polymorphism will be analyzed to define     the relationship with high salt intake and aortic pressure and pulse wave velocity.   "
156335|NCT01237444|"     The purpose of this study is designed to compare the safety, tolerability, antiviral activity     and immunological effect of lopinavir/ritonavir plus lamivudine (3TC) versus standard therapy     with 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) plus     lopinavir/ritonavir in the treatment of naïve HIV-1 infected subjects.   "
159310|NCT01198405|"     To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined     with guideline-driven standard treatment on patients documented with and/or at high risk of     coronary artery disease.   "
156315|NCT01237704|"     In Hong Kong, every 30 and 12.9 in 100,000 males and females respectively has nasopharyngeal     carcinoma (NPC). With early detection and advances in medical care, the number of NPC     survivors post radiotherapy is rapidly growing in Hong Kong. One of the most distressing     consequences post radiotherapy for NPC patients is swallowing disorder, or dysphagia.     Dysphagia in NPC patients almost certainly cause frequent chest infection, dehydration,     malnutrition and limitations to concurrent treatment such as oral medication. Given the     existing large costs NPC patients incur to the healthcare system, dysphagia only serves to     further inflate the soaring costs.      In an attempt to reduce dysphagia related costs to the healthcare system, swallowing     rehabilitation is offered to NPC patients. Currently, two major swallowing rehabilitation     approaches are commonly adopted. The first is traditional rehabilitation, which involves     patients performing various oropharyngeal exercises aimed at improving swallowing physiology.     The other swallowing rehabilitation approach is transcutaneous electrical stimulation, which     entails using small amount of electric current to increase muscle strength while patients are     engaged in swallowing activities. These two methods are proven as effective in patients with     stroke and head and neck carcinoma patients. Neither of these methods, nevertheless, yields     any efficacy studies in treating NPC patients. Yet, clinicians continue to use either one or     both rehabilitation methods as swallowing rehabilitation.      This study aims to address the gap in efficacy studies on swallowing rehabilitation for NPC     patients post radiotherapy. The research results should provide justification for     rehabilitation time, clinicians' efforts, costs involved and resources used in rehabilitating     the swallowing difficulties of the NPC patients.   "
156316|NCT01237691|"     The phase I evaluation is intended to assess whether or not frequent drug testing and     immediate short-term incarceration for drug use and/or other violations and mandated drug     treatment for multiple violations, reduces the recurrence of drug use and/or other violation     behaviors by California parolees assigned to the study group.   "
156317|NCT01237678|"     The purpose of this study is to test safety and efficacy of this combination treatment     (IMGN901, carboplatin and etoposide) in patients with solid tumors and extensive stage small     cell lung cancer.   "
156318|NCT01237665|"     This is a prospective open label single-arm, single-institution phase II clinical trial to     test the efficacy of neoadjuvant treatment with IXO (Irinotecan, Capecitabine [Xeloda],     Oxaliplatin) followed by chemoradiotherapy and resection in patients with resectable     non-metastatic primary rectal cancer of stage cT3-T4 N0-N2.   "
156319|NCT01237652|"     During or after surgery, patients may suffer heart attacks or other heart complications,     increasing the hospital stay by 11 days on average and costing an estimated US$20 billion in     1990.Many risk factors have been identified but there are no properly conducted studies to     look at Blood pressure (BP) as a risk factor around the time of surgery. The investigators     believe there is a good possibility that systolic BP (SBP) is a risk factor but currently     unrecognized. When measuring BP, two numbers are obtained. The upper number is called SBP and     a lower number called diastolic BP (DBP). If the numbers are high, this means that the     patient has a high BP or hypertension. If the SBP is high while DBP is normal, it is called     isolated systolic hypertension (ISH)> ISH is increasingly recognized as a major risk factor     for heart problems. The relationship between ISH and heart complications around the time of     surgery is poorly understood. Previous studies did not look at such a relationship. Because     of that, there are no guidelines for ISH management at the time of surgery. Generally, these     patients go through surgery as if they have no increased risk. Studies are starting to show     that the bulk of these heart complications happen in patients thought to have low risk     factors not yet identified, including ISH.      The investigators believe that the oxygen supply to the heart can be compromised around the     time of surgery in ISH patients Chemicals known as stress hormones are secreted around the     time of surgery, increasing oxygen needs in the heart and may make the oxygen supply to the     heart muscle critical (know as myocardial ischemia). This in turn may result in a heart     attack and death. Studies have shown that patients with myocardial ischemia stand a 9-fold     increase in odds ratio of suffering a heart attack, worsening of angina, or death.      This study aims to compare the incidence of myocardial ischemia in patients with ISH and     normal BP patients around the time of surgery using a special heart monitor. In addition, the     study aims to determine the prevalence of ISH among surgical patients and to document     complications like heart attacks, heart failure, stroke and death after surgery.      This research project will be conducted at the Ottawa Hospital by a multi-disciplinary     research group (perioperative research group)which includes anesthesiology, cardiology,     general surgery and epidemiology. The research group secured HSFO funding for this study.   "
156320|NCT01237639|"     Transfusion of red blood cells (RBCs) is important for the care of patients undergoing stem     cell transplantation. Stem cell transplants are used to treat blood cancers and bone marrow     disorders. This involves the use of high doses of chemotherapy and/or radiation to kill     cancer cells; but this damages the marrow and blood system. Blood stem cells are transplanted     by infusing into the recipient and blood counts recover over 2-3 weeks. Before bone marrow     recovery, RBCs are needed to support the patient. Higher hemoglobin in these high risk     patients may have benefits such as better energy and organ function. However, research in     other areas of medicine suggests that a higher red cell count may be dangerous. Taken     together, it is unclear whether having a lower or higher red cell count is better for     patients having a blood stem cell transplant. The investigators plan to study this by     randomly assigning patients having a transplant to be transfused with RBCs either at a higher     or lower hemoglobin level. In this way, the investigators will be able to accurately find out     if there are any benefits or harms in having a lower or higher red cell count during the     recovery period after blood stem cell transplantation.   "
156321|NCT01237626|"     The following study is designed in order to effectively collaborate and coordinate     information amongst colleagues to advance knowledge on information related to older drivers.     Candrive is dedicated to improving the safety and quality of life of older drivers. The major     objective is to develop a valid, easy to use in office screening tool that will help     clinicians identify older drivers who need further assessment of their driving. Over the     course of the study, the goal will be to provide enough data to establish findings relating     to knowledge generation, translation of research into action, training and sustainability. It     is our hope that the research process will translate to help increase the knowledge of public     policy makers, clinicians and the general public. A 5 year study will create an opportunity     to document the natural course of an older adult's driving patterns up until driving     cessation. This will not only provide data for road safety but also help understand the     psychosocial factors leading to driving cessation. The data relating to psychosocial factors     may also lead the way in establishing ways of extending the safe driving period for older     adults.      The investigators hypothesize that the knowledge derived from this interdisciplinary research     will be used by transportation policy makers, clinicians, and general public to improve     safety and quality of life for older drivers.   "
156322|NCT01237613|"     The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue     Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with     regard to lower leg and foot function, pain and quality of life.   "
156323|NCT01237600|"     The purpose of this study is to elucidate the appropriate condition of developing cultivated     corneal epithelial graft and evaluate the surgical outcome of transplantation of the     cultivated corneal epithelial stem cell in the patients.   "
156324|NCT01237587|"     The purpose of this study is to determine whether duloxetine is safe and effective in the     treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).      This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and     an open label extension period of 26 weeks.   "
156326|NCT01237561|"     This project will evaluate the translation of the Gold (the Global Strategy for the     Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) COPD     guidelines into primary care practice. During phase I, a needs assessment will evaluate     barriers and facilitators to implementation of COPD guidelines into clinical practice through     focus groups of primary care patients and providers. Using formative evaluation and feedback     from the focus groups, three tools will be developed, refined and pilot tested. The     effectiveness of the materials developed in phase I will be tested in phase II (a randomized     clinical trial conducted with one year of intervention within non-academic primary care     practices) regarding physician performance of COPD guideline implementation and improvement     in the clinically relevant outcomes (appropriate screening, diagnosis and management of COPD)     compared to usual care.   "
156327|NCT01237548|"     Title: The acute effect of narghile smoking on endothelial Function, and exhaled breath     condensate (EBC) and pulmonary function tests in healthy volunteers.      Objectives: To evaluate the acute effect of one cession of narghile smoking on endothelial     Function, airway inflammation as assessed by exhaled breath condensate (EBC) in healthy     volunteers.      Design: Prospective study evaluating these parameters before and after 30 minutes of Narghile     smoking. The changes in inflammatory parameters pre and post smoking will be evaluated     blindly.      Sample size: 50 participants Participant selection: Adults subjects who smoke Narghile .     Intervention: Each subject will undergo evaluation including a respiratory questionnaire,     endothelial Function , pulmonary function tests , exhaled breath condensate (EBC) and     carboxy- hemoglobin levels . All measurements will be evaluated before and after one cession     of 30 minutes narghile smoking.   "
156328|NCT01237535|"     This is a single center, 3 arms, prospective randomized controlled open study to determine     the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles     with recombinant FSH in patients with unexplained infertility and mild male factor.      Patients will be randomized into 3 groups:        1. Luteal support with progesterone only (they will received vaginal P gel (Crinone 8%          vaginal gel; Serono, Israel)        2. Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel)          and Estrofem 4mg].        3. No luteal support   "
156329|NCT01237522|"     The aim of the study is to evaluate the pharmacokinetics of metformin in healthy Caucasians     volunteers with and without the polymorphism A270S in OCT2,thus the study hypothesis is that     renal clearance of metformin is affected in Caucasian with the known single nucleotide     polymorphisms A270S in OCT2.   "
156330|NCT01237509|"     Hypoglycaemia is associated with characteristic changes in the EEG with the appearance of     slow frequency waves. In a recent study the investigators have shown that these changes can     be recorded from subcutaneous electrodes and processed by an automated mathematical algorithm     based on non-linear spectral analysis, and that changes are present before the occurrence of     severe hypoglycaemia in type 1 diabetes patients. An alarm device based on real-time analysis     of continuous EEG-recordings may thus be possible. For many diabetes patients nocturnal     hypoglycaemia is a feared complication which may thus be preventable.   "
156331|NCT01237496|"     This study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis B     treated with Pegasys (peginterferon alfa-2a). Eligible patients will have been randomized in     study ML18253 to receive Pegasys 180 mcg subcutaneously for 48 or 96 weeks. Sample collection     period for each patients will occur in the first 24 weeks.   "
156332|NCT01237483|"     The purpose of this study is to investigate in patients with cancer of the throat and     recurrent inoperable a different modality treatment consisting of radiation continuously for     5 weeks and half associated with a drug directed against a receptor on cell surfaces cancer,     called Erbitux ®.      The investigators hope with this shorter treatment (1.5 weeks less than the usual treatment)     to improve the antitumor efficacy without additional toxic side effects.   "
156333|NCT01237470|"     Contemporary treatment of inguinal hernia is generally based on surgical methods with the use     of synthetic meshes. The implanted meshes however have some disadvantages: they increase the     risk of infection, tend to sustain inflammation process, can generate chronic pain and     fertility disorders, can move from the initial implantation site, increase costs of treatment     etc. The research to find any new hernioplasty without the use of meshes is still going on.      Desarda in 2002 year published his own results over hernia treatment with the use of external     oblique aponeurosis. These results were comparable with the effects of Lichtenstein     technique.      The initial assessment done in our own department revealed good clinical results after hernia     treatment with Desarda's method.      To make appropriate and objective clinical assessment of the Desarda's technique for primary     inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was     projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in     the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation.      Generally no statistically significant differences were found between these groups. The only     difference was higher rate of seroma after Lichtenstein technique and different pain     perception in both groups. To the summary it is clear that Desarda technique is quite     attractive and good proposition for operative hernia treatment without mesh. The RCT was done     with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for     clinical trials.   "
156334|NCT01237457|"     This is a phase II treatment protocol offering 177Lu-DOTATATE therapy for somatostatin     receptor expressing cancers including, but not limited to, those arising from the neural     crest and involving such organs as the lungs, breast, gastrointestinal tract, skin and     endocrine (examples: pheochromocytoma, medullary carcinoma of the thyroid, non radioiodine     avid differentiated thyroid cancer, melanoma, renal cell, Merkel cell, paraganglioma, small     cell lung, Carcinoid and pancreatic islet cell malignancies).   "
156336|NCT01237431|"     In patients with autonomic dysfunction water drinking elicits a pressor response mediated by     sympathetic activation. If any, in healthy subjects there is only a slight increase in blood     pressure. However, the sympathetic activation is observable by resting energy expenditure     increases greater than 20%.      The investigators believe that the response to water may be mediated through sympathetic     activation elicited by osmosensitve spinal afferents in the liver. Therefore, the     investigators want to test water in liver transplant patients who have a denervated liver.     Kidney transplant patients serve as control subjects. The investigators hypothesize that the     increase in norepinephrine after water drinking is blunted in liver transplant recipients.   "
156337|NCT01237418|"     The observatory FAST MI 2010 proposes to establish a cohort of 3500 patients recruited     prospectively over a period of 2 months.      Patients will be followed up at 1 month and then followed annually for 10 years.      Patients should have agreed to participate in the study, participation in the protocol, or     refusal to participate will not affect the therapeutic approach of the physician. The study     of genotypic or phenotypic characteristics will not change the therapeutic approach of health     care teams.   "
156338|NCT01237405|"     The purpose of this study is to evaluate 99mTc - EC20 imaging (FolateScan), a Nuclear     Medicine imaging technology that enables localization of activated macrophages in the joints     of participants with knee osteoarthritis (OA). Twenty five participants with symptomatic     unilateral or bilateral knee OA will undergo a one-time evaluation of the knee as follows:     knee radiography, FolateScan of the knees and whole body, musculoskeletal exam,     questionnaires, sampling of blood, urine and synovial fluid for analysis of inflammatory     markers. Data analysis will be cross-sectional and include a comparison of the location and     intensity of EC20 uptake with the following: radiographic knee OA severity, clinical measures     of disease severity, cytokine expression, and synovial fluid cell count.   "
156339|NCT01237392|"     A single center, randomized, parallel, clinical outcome trial to compare the rate of healing     in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation)     or standard of care sharp debridement.   "
156340|NCT01237379|"     The purpose of this study is to screen for peroxisome defects in child and adolescent     offspring of Bipolar Disorder I (BD-I) parents at different stages of risk for transitioning     to mania and following the onset of mania.      Prediction 1: Youth with an elevated risk for developing BD-I and first-episode manic     patients will exhibit graded deficits in measures of peroxisomal function compared with     healthy controls.      Prediction 2: Indices of peroxisomal function will be correlated with Red Blood Cells     Docosahexaenoic acid (DHA) composition.      Prediction 3: Graded deficits in measures of peroxisomal function will be inversely     correlated with manic and depression symptom severity scores.   "
156341|NCT01237366|"     This Phase Ib pilot RCT will examine the safety, feasibility, and acceptability of a     multi-component intervention to address traumatic stress symptoms among HIV-positive,     methamphetamine-using men who have sex with men (MSM). Following a baseline assessment, 56     participants will be randomized to receive either: 1) a 7-session intervention to address     traumatic stress related to living with HIV/AIDS; or 2) a 7-session, attention-control     condition. Follow-up assessments will be administered at 1 and 3 months post-randomization.   "
156342|NCT01237353|"     In this study the investigators will test a nutritional supplement called betaine     hydrochloride to see if it can temporarily increase the stomach acid in healthy volunteers     who have decreased stomach acid because they take a medicine called rabeprazole.   "
156343|NCT01237340|"     To assess the immunogenicity of Saizen® solution for injection in adult subjects with     documented Growth Hormone Deficiency (GHD).   "
156344|NCT01237327|"     Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women     with natural or induced postmenopausal status with advanced breast cancer whose disease has     progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had     participated on an original study of exemestane vs megestrol : study 971-ONC-0028-080.   "
156345|NCT01237314|"     This study will record the impact of food on blood glucose levels using continuous glucose     monitoring (CGM).      The investigators think the impact will improve as medication doses are adjusted. The     investigators also think that the impact will differ depending on the type of medication     taken.   "
156346|NCT01237301|"     The purpose of this study is to evaluate the use of SMBG and CGM for clinical decisions     related to the management of type 2 diabetes. The secondary objective is to determine the     benefit of using CGM for clinical diabetes management decision-making.   "
156347|NCT01237288|"     The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521)     in subjects with primary hypophosphatemic rickets.   "
156348|NCT01237275|"     First, the investigators examined the functional relevance of serotonin transporter     polymorphisms by quantifying the activity of serotonin transporter in blood platelets of     genotyped healthy volunteers and patients with major depression.      Second, the investigators studied response to SSRIs in relation to 5-HTTLPR genotype and also     to the functional expression of 5-HTT in platelets.   "
156349|NCT01237262|"     The efficacy of TNF alfa inhibitors in the treatment of psoriasis has been documented in many     studies.      Their effect on dendritic cells has been scarcely studied. TNF- α has a central role in     dendritic cell biology, both for their maturity and mobilization of peripheral tissues to     secondary lymphoid organs.      The primary objectives of this study are:        -  To document absolute number, density of immune infiltrate and dendritic cells and          inflammatory cytokines expression pattern (particularly IFN α and IL-32) in psoriasic          lesions vs normal skin of the same patient        -  To describe changes in such cell numbers and expression patterns upon 16 weeks treatment          with TNF alfa inhibitors.   "
156372|NCT01236963|"     It is difficult to obtain patient's compliance with regular interproximal dental hygiene.     Dental floss is recognized as an effective procedure to remove dental plaque and prevent     gingivitis in the space between teeth, but it is difficult to use and most patients do no do     it regularly. Essential oils mouthrinse acts on dental plaque bacteria and helps on     gingivitis prevention. These properties may be of interest to control dental plaque     accumulation and gingivitis in interproximal areas. The study hypothesis states that there     are no differences between the use of an essential oils mouthrinse and dental floss on the     reduction of dental plaque accumulation and gingivitis.   "
156377|NCT01236898|"     The aim of this study is to investigate pharmacokinetics and safety of N-acetylneuraminic     acid in patients with Distal myopathy with rimmed vacuoles (DMRV) - hereditary inclusion body     myopathy (hIBM). Dosages are 800mg single and three times a day and 800mg 3 times a day for 5     consecutive days. N-acetylneuraminic acid and N-glycolylneuraminic acid in serum and urine     are measured before and after oral administration of N-acetylneuraminic acid.   "
156378|NCT01236885|"     This clinical trial studies computer-guided glucose management systems in treating patients     with hyperglycemia who have undergone blood and bone marrow transplant. A computer-guided     glucose management system may help manage glucose levels in patients who have undergone blood     or bone marrow transplant.   "
156350|NCT01237249|"     This is a national, multicenter, open-label, randomized, comparative study designed to     compare, first, the TTP of the two treatment schemes proposed (MPV followed by Rd or MPV     alternating with Rd) in newly diagnosed MM patients older than 65 years. This comparison will     be performing in terms of both efficacy and safety. Up to 120 patients will be included in     each treatment arm and evaluated at scheduled visits in up to 3 study periods: Pre-treatment,     Treatment and Follow-up.      Primary outcome measure:        -  To evaluate the efficacy in terms of time to progression (TTP) at 18 months of MPV and          Rd used as either in a sequential or alternating approach in newly diagnosed MM patients          older than 65 years.        -  To evaluate the toxicity (safety and tolerability) of the sequential versus the          alternating use of MPV and Rd.      Secondary outcome measure:        -  To evaluate the response, duration of response, progression free survival (PFS), time to          next therapy (TNT) and overall survival (OS) in the two different groups of patients.        -  To identify, within the group of patients treated with the alternating scheme, the          biological characteristics (including a comprehensive genomic analysis) of those          patients resistant to one or the other, and patients refractory to both treatments   "
156351|NCT01237236|"     LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6.     CDK4/6 is involved in the process that allows both normal and cancer cells to divide and     multiply. Cancer cells are often driven to divide and multiply by abnormalities that increase     the activity of CDK4. Hence there is hope that blocking the activity of CDK4 may slow the     growth of some cancers. LEE011 has shown anti-cancer activity in several different tumor     models in animals.      Because CDK4 is important in both normal and cancerous cells, LEE011 is expected to decrease     the ability of the bone marrow to make white blood cells, platelets, and red blood cells.     Although these effects are expected to be reversible, they can increase the risk of     infection, bleeding and fatigue.      The primary purpose of this study is to find the highest dose of LEE011 that can be safely     given to adult patients with advanced solid tumors or lymphomas for which no further     effective standard treatment is available. It will provide information about the side effects     that may occur following treatment. The study will also possibly provide early evidence for     LEE011's anti-tumor activity.   "
156352|NCT01237223|"     The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and     safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with     essential hypertension (mean sitting diastolic blood pressure [msDBP] ≥ 95 mmHg and < 110     mmHg and mean sitting systolic blood pressure [msSBP] ≥ 140 mmHg ). This study was conducted     to support registration of the fixed-dose combination of aliskiren and amlodipine for the     treatment of hypertension in Japan.   "
156353|NCT01237210|"     This study is looking for healthy controls and patients with Parkinson's (PD) to perform an     MR scan.        1. The neurochemical profile of the SN of patients with PD as measured by high field MRS          will differ from that of healthy controls, in that glutathione will be lower due to          oxidative stress, lactate will be higher due to mitochondrial dysfunction, the gliosis          markers myo-inositol and glutamine will be higher due to inflammation (glial activation)          and N-acetylaspartate and glutamate will be lower due to neuronal loss/damage.        2. There will be a relationship between neurochemical changes and disease severity.   "
156354|NCT01237197|"     Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated     with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM).     Obesity tracks strongly into adulthood and interventions early in life may reduce risk for     developing cardiovascular disease and type 2 diabetes. Few drug therapies for weight loss     have been evaluated in adolescents. Since exenatide is associated with weight loss and     improves risk factors for cardiovascular disease and type 2 diabetes in adults, it may be     useful in extremely obese youth. Our primary objective in this study is to generate     preliminary data on the ability of exenatide to reduce body mass index (BMI) and improve risk     factors for cardiovascular disease and type 2 diabetes in 26 extremely obese adolescents (age     12-19 years) in a three-month, randomized, double-blind, placebo-controlled pilot clinical     trial. GLP-1 therapy has never been evaluated as a treatment for pediatric obesity and is an     innovative approach to a challenging and significant health care problem.   "
156355|NCT01237184|"     The primary purpose of this study is to        1. determine whether dental implant engaging both the alveolar crest cortical bone and          sinus floor using vertical stopper drill and self-threading concept (bi-cortical          fixation) increases initial implant stability compared to the short implants engaging          only alveolar crest cortical bone (uni-cortical fixation) and/or ones engaging both          crest and sinus floor but with green stick fracture (indirect sinus lift technique),        2. study whether different surgical techniques, residual bone height, bone density, and          length and width of the implants used affect initial implant stability in posterior          maxilla. In addition, this study will continue to        3. compare secondary implant stability of implants fixed bi-cortically, uni-cortically and          with indirect sinus lift technique at 2nd stage surgery/6 month healing and 1 year          follow-up from the restoration and        4. measure amount of endo-sinus bone formation from the 1- year follow up CT (computer          tomogram) scan and evaluate safety and potential post-operative complications of          bi-cortical fixation and indirect sinus lift technique reported throughout the follow up          periods.   "
156356|NCT01237171|"     For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is     usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of     lung may leave too little lung behind for easy breathing. For some of these patients, it may     be possible to perform a smaller-scale surgery (sub-lobar resection) and place a     radioactive implant behind to prevent the cancer from growing back. This study will see how     these patients do in terms of controlling their disease treated with a radioactive implant     called Cesium-131.   "
156373|NCT01236950|"     The use of mouthrinses may be of relevance as a complement to daily dental hygiene     procedures, especially for patients who do not comply with a proper mechanical removal of     dental plaque. Essential oils and delmopinol mouthrinses are effective to reduce dental     plaque accumulation and gingivitis. Also an effect on dental bacteria can be found. The study     hypothesis states that there are no differences between the mouthrinses on the reduction of     gingivitis and dental plaque accumulation as well on the bacterial counts of Streptococcus     mutans, Lactobacillus, aerobic and anaerobic bacteria.   "
156357|NCT01237158|"     Background: The pathophysiological mechanisms of bipolar disorder are not completely     clarified and several hypothesis have already been formulated including the role of     monoamines, gama amino butyric acid (GABA) and glutamate. GABA is the main inhibitory     neurotransmitter while glutamate is the main excitatory neurotransmitter. Genes that play a     role in GABA metabolism and in the activity of GABA neurons are very important to understand     the GABA function, once they affect neurodevelopment and its dysfunctions may predispose to     neuropsychiatric diseases. The two genes that are going to be study in this project are     glutamic acid decarboxylase (GAD1) and reelin (Reln). The enzyme glutamic acid descarboxylase     (GAD67) metabolizes glutamate in GABA in the pre synaptic neuronal regions and is coded by     the gene GAD1. Reelin is secretory serine protease with dual roles in mammalian brain:     embryologically, it guides neurons and radial glial cells to their corrected positions in the     developing brain; in adult brain, Reelin is involved in a signaling pathway which underlies     neurotransmission, memory formation and synaptic plasticity. Magnetic resonance spectroscopy     (MRS) studies on bipolar disorder show a number of alterations in cerebral level of GABA and     glutamate in different cerebral areas when compared to healthy subjects and other mood     disorders. Objective: Investigate in bipolar patients and healthy controls the association of     GAD1 and Reln single nucleotide polymorphisms(SNP) and cerebral levels of GABA/glutamate on     MRS. Methods: 70 symptomatic bipolar I patients medication free and 70 healthy controls are     going to be genotyped for GAD1 and Reln SNPs and GABA/glutamate MRS.      Key words: GAD1, GAD67, bipolar, GABA, Glutamate, Reelin, Rln, Spectroscopy.   "
156358|NCT01237145|"     The purpose of this study is to establish if cells present in lung tissue during extrinsic     allergic alveolitis (EAA) are able to elicit an immune response against specific antigens.     The hypothesis is: cells in BAL lavage fluid from patients with EAA will be responsive to     specific antigens and this response can be measured using ELISPOT.   "
156359|NCT01237132|"     The current treatment guidelines of hepatocellular carcinoma (HCC) of the American and     European Associations for the Study of Liver Disease are based on the     Barcelona-Clinic-Liver-Cancer classification (BCLC), which does not recommend surgery in     patients with large, multinodular and macrovascular invasive disease. The aim of this study     was to investigate the role of hepatic resection in a large retrospective multicentric cohort     of patients resected for HCC regardless of the BCLC indications.   "
156360|NCT01237119|"     The purpose of this study is to investigate whether 48 weeks treatment with once-daily     injections of liraglutide improves liver disease (liver fat, inflammation and scarring) and     related metabolic parameters in overweight patients with nonalcoholic steatohepatitis, enough     to warrant further investigation.   "
156361|NCT01237106|"     This pilot study will be a prospective investigation to study the efficacy and safety of     In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10     subjects total in this Study. There will be no blinding to treatment.      In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting     pregnancy through the use of Assisted Reproductive Technology (ART).   "
156362|NCT01237093|"     Background:      - Researchers who study health and nutrition are interested in developing more accurate     methods of determining what people eat from day to day and how it affects their general     health. In particular, better methods are needed to determine if people are accurately     remembering what they ate. One possible method involves the use of biomarkers, or indicators     in urine, blood, saliva, fat, and hair, which are related to the intake of a particular food     in a consistent way. One set of biomarkers in blood samples and hair may be used to determine     the relative amount of meat, fish, and soda (corn/sugar cane) in a person s diet. However,     more research is needed to study the effectiveness of using these biomarkers to accurately     track dietary intake.      Objectives:      - To validate the use of biomarkers as representative of specific dietary intake patterns     (meat/fish/soda).      Eligibility:      - Healthy, nondiabetic men between 18 and 65 years of age.      Design:        -  This study involves an initial screening visit and a 12-13 week inpatient dietary study          period.        -  Participants will be screened with a medical history and physical examination, as well          as blood and urine samples and a glucose tolerance test to exclude individuals who have          diabetes.        -  After 3 days of a standard weight-maintaining diet, participants will have a glucose          tolerance test and a body fat scan; provide hair, blood, and fat tissue samples; and          complete questionnaires and performance tests.        -  Participants will spend one day in a metabolic chamber to measure their energy          expenditure and general metabolism.        -  Participants will then be randomized into one of eight carefully designed diets for 12          weeks. The diets will differ in the amount of meat, fish, and soda, including one diet          where none of the three biomarker-related foods will be permitted. Blood samples will be          collected throughout the study diet period.        -  At the end of the 12-week study diet period, participants will provide additional hair,          blood, and fat tissue samples, and will have a second metabolism assessment in the          metabolic chamber.   "
156363|NCT01237080|"     The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation     of morbidly obese. Mainly we will try to clarify which of the instruments that produce the     shortest intubationtime and lowest number of intubationattempts.      The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of     attempts, using the GlideScope®.   "
156364|NCT01237067|"     Background:      - Olaparib is an experimental anti-cancer drug that is part of a class of drugs called PARP     inhibitors. PARP is a protein that is involved in repairing DNA damage, but it may also     encourage precancerous cells to develop into cancer cells. Olaparib has been given safely in     combination with carboplatin, a drug used to treat breast, ovarian, uterine, and cervical     cancer, but more research is needed to determine whether the drugs are more effective when     given together or which drug should be given first.      Objectives:      - To determine the safety and effectiveness of combined carboplatin and olaparib as a     treatment for gynecologic (female organ) or breast cancer.      Eligibility:        -  Women at least 18 years of age who have breast, ovarian, uterine, or cervical cancer          that has not responded to standard treatments.        -  Men at least 18 years of age who have metastatic breast cancer and have a BRCA-1/2          mutation.      Design:        -  Participants will be screened with a physical examination and medical history, as well          as blood and tumor samples and imaging studies as required by the researchers. Study          participants will then be divided into two groups.        -  Group 1: Participants will receive olaparib tablets twice a day for 7 days (14 doses)          and will receive carboplatin by vein on day 1 or 2, for a 21-day treatment cycle. Group          1 study is designed to determine the safety of new tablet formulation of olaparib.        -  Group 2: Participants will be divided into two smaller groups, with reversed treatment          schedules. Group 2 study is designed to evaluate which drug should be given first          through endpoint studies in blood samples.        -  Group 2A: Participants will receive olaparib tablets twice a day for 7 days (14 doses)          and then carboplatin on day 8 of the first cycle. Cycle 2 will start with carboplatin on          day 1 and olaparib starting on day 2 for 7 days (14 doses).        -  Group 2B: Participants will receive carboplatin on the first day of the first cycle, and          then olaparib on day 2, twice a day for 7 days (14 doses) of the first cycle. Cycle 2          will start with 7 days of olaparib (14 doses) and carboplatin will be given on day 8.        -  From cycle 3 until completion of therapy, all Group 2 participants will follow the          schedule used for Group 1 (carboplatin on day 1 or 2 of the week of olaparib therapy,          also in 21-day cycles).        -  Additional blood and tissue samples and imaging studies will be conducted throughout the          treatment period.        -  All participants may receive no more than 8 cycles of olaparib and carboplatin therapy,          but may continue to take olaparib if their cancer responds to the treatment.   "
156374|NCT01236937|"     The primary outcome of this study is to investigate the accuracy of respiration gated laser     guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based     breath hold monitoring system. Secondary outcome is the rate of complications using laser     guided CT biopsy in general and with bellows-based breath hold monitoring system. The study     has approval from the The Danish National Committee on Biomedical Research Ethics (ref no:     H-4-2010-fsp 1).   "
172243|NCT00096824|"     The purpose of this study is to determine how often dementia and other neurological problems     occur in people with HIV. Participants of ACTG A5175 will enroll in this study.   "
156365|NCT01237054|"     Background:      - Recent studies have shown that the premalignant conditions monoclonal gammopathy of     undetermined significance (MGUS) and smoldering multiple myeloma (SMM) have a high risk of     progressing to multiple myeloma (MM). There are currently no known effective treatments to     prevent MGUS or SMM from developing into MM, and there are no known tests for determining     whether an individual with MGUS or SMM will develop MM. Researchers are investigating new and     improved imaging techniques that may be able to better detect the progression of MGUS or SMM     into MM.      Objectives:        -  To compare the results of three imaging techniques in individuals with MGUS, SMM, and          MM.        -  To correlate the information from the imaging studies with established clinical markers          of progression from MGUS/SMM to MM.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with monoclonal gammopathy of     undetermined significance, smoldering multiple myeloma, or multiple myeloma.      Design:        -  Participants will be screened with a physical examination and medical history, and will          provide baseline blood, urine, and bone marrow samples before beginning the imaging          studies.        -  Participants will have three imaging studies on separate days: a standard          18-fludeoxyglucose positron emission tomography/computed tomography scan (18-FDG          PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT),          and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).        -  Participants will be closely monitored during each scan, and will provide additional          blood samples before and after the scans.        -  Participants may provide additional blood, urine, tissue, and bone marrow samples for          optional research studies.   "
156366|NCT01237041|"     Background:      - Overweight and obese children and adults often have lower levels of growth hormone in the     blood. Regulation of growth hormone may be tied to weight and free fatty acids in the blood.     Current tests of growth hormone (such as those used when evaluating the heights of children     who are markedly shorter than other children of comparable age) may be affected by other     factors, including obesity. Researchers are interested in evaluating the levels of growth     hormone and free fatty acids in the blood of children between 7 and 14 years of age who weigh     more than children of a comparable age, or who are shorter than other children of a     comparable age and have been recommended for growth hormone testing as part of an evaluation     for their height.      Objectives:      - To determine the effect of changes in free fatty acids in the blood on changes in growth     hormone secretion in overweight or shorter children and young adolescents.      Eligibility:      - Children and adolescents between 7 and 14 years of age who weigh more than or are shorter     than other children of a comparable age and do not have any medical illnesses.      Design:        -  Participants will have two study visits, one of which will be a half day screening visit          in the outpatient clinic and one of which will require 2 nights as an inpatient at the          National Institutes of Health Clinical Center.        -  Participants should not eat or drink anything except water after 10 PM the night before          or on the morning of the screening visit.        -  At the screening visit, participants will have a physical examination and medical          history, provide blood and urine samples, have an oral glucose tolerance test (to check          blood sugar levels), and have an x-ray of the left hand to check bone age.        -  The inpatient study visit will involve a physical examination and medical history, a          full x-ray scan to study body fat and muscle, frequent blood tests throughout the visit,          and various medications to stimulate growth hormone production and lower levels of free          fatty acids in the blood.   "
156367|NCT01237028|"     This study will help to show the efficacy of vitamin D and address the optimal strategy to     minimize renal injury in IgAN patients.   "
156368|NCT01237015|"     Current knowledge suggests that, to be successful, oral feeding in preterm babies should be     initiated as soon as possible, often at an age where immature respiration still requires     ventilatory support in the form of continuous positive airway pressure (CPAP). While some     neonatologist teams claim great success with initiation of oral feeding in immature babies     with CPAP, others strictly wait for CPAP to be no longer necessary before any attempt at oral     feeding. Such controversy is fuelled by ignorance of the effects of CPAP on nutritive sucking     and swallowing, including their coordination with breathing, and the fear to induce     deleterious problems such as pulmonary aspiration of milk and/or respiratory failure. Ensuing     delay in becoming proficient with oral feeding unduly prolongs hospital stays of preterm     babies.      The aim of this study is to evaluate the effects of nasal CPAP on oral feeding in human     neonates. More specifically, CPAP effects on nutritive sucking and swallowing, including on     breathing-swallowing coordination, will be carefully assessed. The investigators hypothesize     that nasal CPAP will lead to no or minimal alterations of breathing-nutritive swallowing     coordination and will not induce deleterious cardiorespiratory events.      Accordingly, each neonate will be evaluated during 2 bottle feedings spaced of 24 h, one with     nasal CPAP 5 cm H2O and the other without any CPAP. Sucking and swallowing activity,     respiration, heart rate and oxygenation will be continuously recorded before, during and     after bottle-feeding.      By filling a gap in knowledge, results from the study will hopefully help neonatologists     afraid of doing more harm than good when initiating bottle-feeding in preterm babies under     CPAP to join the many teams for whom it is no more a problem.   "
156369|NCT01237002|"     Intermittent Pringle's maneuver is widely used to limit blood loss during hepatectomy,     without an established time-limit. However, many authors claims its danger for patients'     outcome. The investigators check the short term outcome of a consecutive cohort of patients     who underwent hepatectomy with intermittent clamping exceeding 120 minutes.   "
156370|NCT01236989|"     Prognostic impact of AR vs NAR   "
156371|NCT01236976|"     The study is a multi-centre, assessor-blind, randomised controlled phase III trial in     patients with with complete or incomplete spinal cord injury between C6 and T12. A total of     188 participants will be randomised into two groups, the experimental group and the control     group. The control group participants will receive an upper body strength and fitness     program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental     group participants will receive a comprehensive full body exercise program, conducted for 2-3     hours, three times per week for 12 weeks.      The main objective of this study is to determine if the experimental exercise program is more     effective than the upper body strength and fitness program in promoting neurological     improvement in participants with spinal cord injury.      Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week     treatment period followed by 6 month and 12 month (from baseline) follow up assessments.      Participants will be assessed by a blinded assessor (the assessor will not know which group     the participants are in) using standard physiotherapy, neurophysiological, fitness and     functional tests, psychological and quality of life questionnaires, as well as tests of     immune function and bone structure.   "
156375|NCT01236924|"     Slipped disc is the rupture of the fibrous ring, with subsequent displacement of the nucleus     pulposus in intervertebral spaces, which may cause compression of nerve structures. It is     estimated that 2-3% of the population have taken with this process, whose prevalence is 4.8%     in men and 2.5% in women over 35 years. Thus, the purpose of this study is to verify the     effectiveness of global postural reeducation in patients diagnosed with chronic symptomatic     lumbar disc herniation with the application of a randomized controlled trial. Will be     measured pain, disability and functional flexibility.   "
156379|NCT01236872|"     Inorganic nitrate can be converted to nitrite and thence nitric oxide in humans. Nitric oxide     is normally produced by the inner lining of blood vessels and helps keep blood vessels open     and therefore blood pressure lower. In subjects with high blood pressure, the inner lining of     the blood vessels does not function adequately. The investigators wish to investigate whether     elevating systemic levels of inorganic nitrate (through provision of dietary nitrate-rich     vegetables) can elevate levels of nitrate/nitrite in hypertensive subjects, and whether this     has a beneficial effect on blood pressure.   "
156380|NCT01236859|"     Intrathecal morphine provides good postoperative analgesia for up to 18-24 hour after     administration. Pruritus is the most common side effect of intrathecal morphine, which the     incidence was reported as 20%-100%2 and 63% in Songklanagarind Hospital. Pathophysiology of     opioid-induced pruritus remain unclear and more than one mechanism may be involved in the     development of opioid-induced pruritus, such as, mediated central µ opioid receptors,     Dopamine (D2) receptors, Serotonin (5-HT3) receptors, prostaglandin system, GABA receptors,     and glycine receptors, so that why opioid-induced pruritus is difficult to manage. Many     medications have been used to treat this side effect included antihistamines, 5-HT3     (serotonin) receptor antagonists, opioid antagonists, opioid agonist-antagonists, propofol,     and nonsteroidal antiinflammatory drugs.      Gabapentin is an anticonvulsant, a structural analog of aminobutyric acid, and currently     approved by the Food and Drug Administration for the treatment of partial seizures and     postherpetic neuralgia. Many studies have shown gabapentin to be effective in the case of     brachioradial pruritus, itch of neuropathic in origin, uremic pruritus, multiple     sclerosis-induced pruritus,cholestatic pruritus, itch produced by burn, and pruritus of     unknown origin. However, there is only one small study in Taiwan shown the effectiveness of     gabapentin 1200 mg in prevention of intrathecal morphine-induced pruritus in orthopedic     surgery, which could reduce incidence of pruritus from 77.5% to 47.5% (38.7% reduction).     Because gabapentin has several side effects especially in high dose such as drowsiness, dry     mouth, headache, unsteadiness, reduced co-ordination or slowed reaction, constipation,     diarrhea, peripheral edema, dizziness, confusion, loss of concentration, weight gain, and     nausea, vomiting, so in our study we decided to reduce the dose of gabapentin. Therefore, we     would like to know if gabapentin in a smaller dose (600 mg) used in the wider range of age     including the elderly can decrease the incidence of intrathecal morphine-induced pruritus in     orthopedic surgery in Songklanagarind Hospital.   "
156381|NCT01236846|"     Study is a 12-week Double blind,controlled experiments designed to examine the possible     effects of vitamin D receptor gene polymorphisms on the metabolic, inflammatory and oxidative     stress markers in type 2 diabetic patients to vitamin D-fortified yogurt drink intake.   "
156382|NCT01236833|"     The objective of this study is determining if enteral administration of Lactated Ringer's     solution (LR) in preterm infants with feeding intolerance enables for faster advancement of     milk feeding than fasting.   "
156383|NCT01236820|"     The purpose of this study is to determine whether L5, one of the Low Density Lipoproteins, is     an effective predicting factor for cardiovascular disease in chronic renal and hemodialytic     patients.   "
156384|NCT01236807|"     The purpose of this study is to determine if MR Perfusion Imaging is non-inferior to coronary     angiography with measurement of Fractional Flow Reserve (FFR) in guiding management of     patients with stable chest pain.        -  All patients will undergo an MR Perfusion Imaging test.        -  Further management will be guided by the result of the cardiac MRI in half of the          patients (chosen by random).        -  The other half will undergo coronary angiography with measurement of FFR. The result of          this test alone will guide their further management. The result of the initial MR          Perfusion test will not be available to the treating doctors of this group.        -  All patients will receive optimal medical therapy (OMT)        -  All patients will undergo follow-up to find out if they have any relevant heart related          events.   "
156385|NCT01236794|"     The purpose of this study is to examine the effects of a lifestyle intervention program on     type 2 diabetes risk factors and quality of life in overweight Latino youth.   "
156386|NCT01236781|"     This multicenter trial using Hologic digital mammography units will evaluate the specificity     of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D     tomosynthesis imaging in breast cancer screening. Specificity, in this study, will be     measured by the participant call-back rate by each modality. Varying combinations of 2-D     mammography and tomosynthesis projections will be evaluated to optimize the screening     paradigm and limit radiation exposure when tomosynthesis is incorporated. Both prospective     and retrospective imaging data will be assessed.      Hypothesis: Digital breast tomography (DBT) will improve the specificity of breast cancer     screening as measured by a reduction in the call-back rate while maintaining the sensitivity     of cancer detection. This improved accuracy will be achieved by the optimization of the     imaging sequence and number of views obtained at a capped radiation dose in the combined DBT     and 2-D screening sequence.   "
156387|NCT01236768|"     The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal     contraceptive delivery system containing ethinyl estradiol and levonorgestrel.   "
156388|NCT01236755|"     This study aims at investigating the efficacy of myopic control using ortho-k in younger and     older children.   "
156389|NCT01236742|"     The primary aim of this study is to compare eyeball elongation in existing ortho-k subjects     who stop the treatment with subjects who continue ortho-k lens wear and control subjects     wearing single-vision glasses.   "
156390|NCT01236729|"     Knee replacement is an effective treatment in late-stage osteoarthritis. It reduces pain and     improves quality of life. There is, however, limited data concerning its results in older     people and on its effect on how patients survive in regular activities of daily living (ADL),     such as bathing and shopping. In this study, the results of knee replacement are evaluated     from the point of view of disability in everyday activities and self-rated health. Moreover,     association with ADL performance and clinical knee scores and severity of osteoarthritis are     assessed.   "
156391|NCT01236716|"     This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in     advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and     some biomarkers is also to be evaluated.   "
156392|NCT01236703|"     CRP and PCT are not valid parameters of early infection in particularly postoperative     patients. (Sanders et al., A&A, June 2006, Vol.102; Katja et al., Shock, February 2001, Vol     15.2) Better detection systems for SIRS and sepsis are urgently required.      ICIS® (Sysmex intensive care infection score) and ICPS® (Sysmex intensive care prognostic     score) are two new score-systems depending on detectable cellular response of the innate     immune system in human peripheral blood.      The purpose of this observational study is to determine if these scores are superior in early     differentiation between non-infectious SIRS and infectious SIRS (sepsis) in postoperative     patients. Furthermore, the applicability of the scores for triggering start and ending of     anti-infective therapy will be examined.   "
156393|NCT01236690|"     Cinobufacini has the effects of anticancer, improving the liver function, elevation of     immunity and little side effects, and is important and significant for the patients with     hepatitis, liver cirrhosis and hepatomas.      Compared with transarterial chemoembolization (TACE) , the clinical effect of cinobufacini is     non-inferior/ equivalent.Compared with TACE, cinobufacini is superior in security .   "
156394|NCT01236677|"     In the 21st century, threats to human health of new respiratory infectious diseases     increased.      The project aim is to establish pneumonia pathogens network in Beijing and understand the     pathogen spectrum distribution.   "
156395|NCT01236664|"     With the aging of the Canadian population, older workers are accounting for more and more of     the working-age population. Despite recent interest in cognitive training, there are     currently no validated programs that specifically target individuals in the work force. The     investigators will conduct a small-scale randomized controlled trial to test the     effectiveness of the previously developed Memory at Work program. The investigators will     recruit 60 individuals and randomly assign them to the active intervention or a control     intervention. The investigators will examine outcomes related to knowledge, behavioral     change, self-efficacy, objective memory, and workplace productivity. The investigators expect     larger improvements on these measures in the active relative to the control group.   "
156396|NCT01236651|"     Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the     First Stage of Labor in Full Term Primigravidae   "
156397|NCT01236638|"     This extension protocol to the core study CCL09101 allows patients who have tolerated the     drug and derived a clinical benefit, to continue to receive treatment beyond the 9 cycles of     the core protocol. Long term safety and efficacy of CYT387 will be evaluated.   "
156398|NCT01236625|"     Official title:      LAPAD - A prospective study on the effect of adhesiolysis during elective laparotomy or     laparoscopy on per- and postoperative complication, quality of life and socioeconomic costs      Background:      With improved surgical technology and ageing of the population the number of reoperations in     the abdomen dramatically increases. The risk for a repeat laparotomy or laparoscopy is a high     as 30% in the first ten years after a laparotomy. In over 95% of reoperations adhesiolysis is     required to gain access to the abdominal cavity and operation area. Adhesiolysis     significantly increases the risk for inadvertent organ damage, such as enterotomies, leading     to higher morbidity, mortality and socioeconomic costs.      Purpose:      To define the impact of adhesiolysis on per- and postoperative complications, quality of life     and socioeconomic costs.      Design:      Prospective observational study.      Primary outcomes:        -  adhesiolysis time        -  inadvertent enterotomy        -  seromuscular injury        -  miscellaneous organ damage        -  Serious adverse events of operation (anastomotic leakage, delayed diagnosed perforation,          wound infection, abdominal infection, haemorrhage, pneumonia, urinary tract infection,          abscess, fistula, sepsis, death)      Secondary outcomes:        -  Hospital stay        -  Intensive care admission        -  Reinterventions        -  In-hospital costs        -  Parenteral feeding        -  Short term readmissions (30 days)        -  Quality of life (Gastro- intestinal tract complaints, Short Form- 36(SF-36), DASI (Duke          Activity Score Index(DASI) )      Estimated enrollment: 800 start study: 1 june 2008 Inclusion completion date: 1 june 2010     Estimated study completion date: 1 february 2011   "
156399|NCT01236612|"     Malaria is one of the major infectious diseases in the world with a tremendous impact on the     quality of life significantly contributing to the ongoing poverty in endemic countries. It     causes almost one million deaths per year, the majority of which are children under the age     of five. The malaria parasite enters the human body through the skin, by the bite of an     infected mosquito. Subsequently, it invades the liver and develops and multiplies inside the     hepatocytes. After a week, the hepatocytes burst open and the parasites are released in the     blood stream, causing the clinical phase of the disease.      As a unique opportunity to study malaria immunology and efficacy of immunisation strategies,     a protocol has been developed in the past to conduct experimental human malaria infections     (EHMIs). EHMIs generally involve small groups of malaria-naïve volunteers infected via the     bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although potentially     serious or even lethal, Plasmodium falciparum (P.falciparum) malaria can be radically cured     at the earliest stages of blood infection where risks of complications are virtually absent.      The investigators have shown previously, that healthy human volunteers can be protected from     a malaria mosquito challenge by immunization with mosquito-bites under chloroquine     prophylaxis (CPS immunization). However, it is unknown whether this protection is based on     immunity directed towards the liver- or the blood stage of the disease. For future     development of vaccines and understanding of protective immunity to malaria, it is important     to investigate at which level protective immunity is generated by CPS immunization.     Therefore, we aim to investigate whether CPS immunization confers protection to a blood-stage     challenge.   "
156400|NCT01236599|"     The purpose of this study is to compare the response of temperature adaptation in preterm     infant using the polyethylene wrap with and without previous drying.   "
156415|NCT01236404|"     Primary objective:      To evaluate the safety and tolerability of single and multiple ascending doses of PB1023     administered as a subcutaneous (SC) injection in adult subjects with T2DM.      Secondary objectives:        1. To characterize the pharmacokinetic profile of PB1023 after single and multiple          ascending doses of PB1023.        2. To assess the pharmacodynamic response of various single and multiple doses of PB1023          (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in          response to a liquid Mixed Meal Tolerance Test (MMTT).   "
156416|NCT01236391|"     The primary objective of this study was to evaluate the efficacy of ibrutinib in participants     with relapsed or refractory MCL.      The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg     daily) of PCI-32765 in this population.   "
156453|NCT01235910|"     The purpose of this study is to evaluate the safety and efficacy of the blood pressure     medication, aliskiren, in heart transplant patients. In terms of safety, the investigators     will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood     levels of the anti-rejection medication, cyclosporine, in these patients. In terms of     efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart     transplant patients.   "
157161|NCT01226602|"     The purpose of this study is to determine if Ticagrelor increases the Adenosin induced     coronary blood flow velocity.   "
156401|NCT01236586|"     Background:      - The anti-cancer drug RO4929097 is being tested for its ability to block blood vessel growth     to tumors and slow or stop the growth of cancer cells. However, it has been used in only a     small number of adults and has not yet been tested in children. Researchers are interested in     determining whether RO4929097 is a safe and effective treatment for tumors or leukemia that     has not responded to standard treatment.      Objectives:      - To determine the safety and effectiveness of RO4929097 as a treatment for children and     adolescents who have been diagnosed with certain kinds of cancer that have not responded to     standard treatment.      Eligibility:      - Children, adolescents, and young adults between 1 and 21 years of age who have been     diagnosed with solid, nervous system, or blood-based cancers that have not responded to     standard treatment.      Design:        -  Participants will be screened with a medical history, physical examination, blood and          urine tests, and imaging studies. Some participants may also have a bone marrow biopsy          to evaluate the state of their disease.        -  Participants will be separated into three groups: One group will receive RO4929097          alone, and the other two will receive RO4929097 in combination with the          immune-suppressing drug dexamethasone.        -  RO4929097 will be given as tablets on one of two schedules: days 1 to 3 of every week          (Schedule A) or days 1 to 5 of every week (Schedule B). The dosing schedule will be          determined randomly. Every 4-week treatment period is one cycle, and participants may          receive RO4929097 for up to 24 cycles.        -  Participants will have frequent blood and urine tests and imaging studies to evaluate          the progress of treatment, and will be asked to keep a diary to monitor any side          effects.   "
156402|NCT01236573|"     Background:      - One experimental treatment for certain types of cancer is cell therapy, which involves     collecting lymphocytes (white blood cells) from a tumor, growing them in the laboratory in     large numbers, and then modifying the cells with a gene (interleukin-12 (IL-12)) that     stimulates the immune system to attack and destroy the cancer cells. Because this treatment     is experimental, researchers are interested in determining the side effects and overall     effectiveness of cell therapy using white blood cells modified with IL-12 as a treatment for     aggressive cancer.      Objectives:      - To determine the safety and effectiveness of cell therapy using IL-12 modified tumor white     blood cells to treat metastatic melanoma.      Eligibility:      - Individuals greater than or equal to 18 years of age and less than or equal to age 66 who     have been diagnosed with metastatic melanoma.      Design:        -  Participants will be screened with a medical history, physical examination, blood and          urine tests, and imaging studies.        -  Cells for treatment will be collected during tumor biopsy or surgery.        -  Prior to the start of cell therapy, participants will have imaging procedures, heart and          lung function tests, and blood and urine tests, as well as leukapheresis to collect          additional white blood cells.        -  For 5 days before the cell infusion, participants will be admitted for inpatient          chemotherapy with cyclophosphamide and fludarabine to suppress the immune system in          preparation for the cell therapy.        -  Participants will receive the modified white blood cells as an infusion 1 to 4 days          after the last dose of chemotherapy. The day after the infusion, participants will          receive filgrastim to stimulate blood cell growth.        -  Participants will remain as inpatients for at least 5 to 10 days to recover from the          treatment, and will be followed regularly after the treatment to study side effects and          general effectiveness.        -  Participants who initially respond to treatment but have a relapse may have one          additional treatment using the same procedure.   "
156403|NCT01236560|"     This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to     see how well they work compared with each other when given together with radiation therapy     followed by bevacizumab and temozolomide in treating young patients with newly diagnosed     high-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses     high-energy x-rays to kill tumor cells. It is not yet known whether giving vorinostat is more     effective then temozolomide or bevacizumab when given together with radiation therapy in     treating glioma.   "
156404|NCT01236547|"     This randomized phase II trial studies the side effects and how well intensity-modulated     radiation therapy (IMRT) and paclitaxel with or without pazopanib hydrochloride works in     treating patients with anaplastic thyroid cancer. Specialized radiation therapy that delivers     a high dose of radiation directly to the tumor may kill more tumor cells and cause less     damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Pazopanib hydrochloride may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known     whether radiation therapy and paclitaxel are more effective when given with pazopanib     hydrochloride in treating thyroid cancer.   "
156405|NCT01236534|"     The purpose of the study is to assess how safe and effective the drug Lubiprostone is in     people with Multiple Sclerosis (MS)and moderate to severe MS-associated constipation.     Lubiprostone is approved by the FDA for the treatment of two common types of constipation in     adults, chronic idiopathic constipation and irritable bowel syndrome.   "
156406|NCT01236521|"     The CAre Management for the Effective use of Opioids (CAMEO) trial is a 2-arm randomized     clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for     chronic lower back pain. The study aims are: 1) to compare the interventions' (PHARM vs. BEH)     effects on pain intensity, function, and other pain relevant outcomes at 6 months (primary     end point) and 12 months (sustained effect); and 2) to compare the cost-effectiveness of the     interventions   "
156407|NCT01236508|"     The investigators hypothesize that inflammation in carotid plaque is predictive of the extent     of ischemic lesion burden on the brain and will add to risk stratification for individuals     with carotid disease.   "
156408|NCT01236495|"     The purpose of the study is to evaluate the amount of total pethidine requirement during the     48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.   "
156409|NCT01236482|"     In this study the investigators hypothesize that infused combinations of oxytocin and     ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion     of oxytocin alone. In order to perform this study the investigators perform the following     steps:        1. The investigators validate a quantitative measure of uterine tone as our primary          endpoint.        2. The investigators use this endpoint measure in order to determine equipotential doses of          different tocotonic drug regimens, based on the ED50 for each.        3. Using equipontial ratios based on the ED50, the investigators compare hemodynamic and          other side effects of these tocotonic drug regimes. Plasma levels of oxytocin will be          measured.   "
156410|NCT01236469|"     The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human     Heart Valve used in pediatric patients as an aortic valve replacement.   "
156417|NCT01236378|"     Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China     for prophylaxis of organ rejection in renal transplantation. A pharmacokinetic (PK) study to     be conducted in renal allograft recipients was requested by State Food and Drug     Administration (SFDA) to provide further guidance for clinical use.      To minimize risk to patients, this study is designed to collect blood PK samples from renal     allograft recipients who are currently under sirolimus (1 mg tablets) treatment with or     without concomitant medication(s). PK samples will be collected from these patients to     characterize the steady state PK of sirolimus during sirolimus maintenance therapy. This     study will not involve any changes to the established treatment regimen for the patients who     enroll in the study   "
156418|NCT01236365|"     Children with type1 diabetes (T1DM) have increased risk for cardiovascular disease (CVD) due     to chronic increase in the blood sugars and inflammation. If there is also increased in     cholesterol, it creates a highly abnormal environment not fully corrected by improved control     of the blood sugars. CVD remains the principal risk of mortality in T1DM, and its prevention     and treatment, compelling in children. This grant proposal encompasses 3 separate, yet     interrelated projects addressing different aspects of CVD risk in children with T1DM. Project     #1: a randomized controlled trial on the safety and efficacy of a class of drugs called     statins, which lower bad cholesterol in the body, in children with diabetes and elevated     bad cholesterol. We will measure changes in concentration of blood inflammatory markers and     for the 1st time, correlate levels of these markers with changes in blood sugar as measured     by continuous glucose sensors, instruments that measure the blood sugar continuously through     a small needle under the skin. Project #2: is a laboratory study to investigate the genetics     and concentration of key molecules that participate in the inflammatory cascade and     atheromatous plaque formation that causes CVD. Expression levels in children with T1DM will     be compared with those in healthy controls for the 1st time. Project #3: examines the use of     abdominal aortic MRI to measure damage to the arteries in children with T1DM and healthy     age-matched controls. The results of these studies will likely provide important new data on     the use of statins in children with diabetes.   "
156419|NCT01236352|"     The purpose of this first in human study is to determine if BMS-911543 is safe and tolerable     in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to     permit clinical testing at the Maximum Tolerated Dose or at a Clinically Active Dose, and to     determine if BMS-911543 will demonstrate efficacy in symptomatic myelofibrosis.   "
156420|NCT01236339|"     The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS     Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have     cirrhosis of the liver with portal hypertension and difficult to treat ascites.   "
156421|NCT01236326|"     Laparoscopic nephrectomy (removal of the kidney) is the most common procedure for people     donating a kidney to be used for living donor kidney transplantation. Laparoscopic donor     nephrectomy (LDN) was a great advance in the field of living donor kidney transplantation due     to the many advantages it offers over open nephrectomy, including significantly shorter     hospitalization and recovery time, and significantly improved cosmetic result related to the     nephrectomy scar(s). More recently, a new procedure has been introduced to the field of     laparoscopic nephrectomy, called laparoendoscopic single site donor nephrectomy (LESS-DN). In     the LESS-DN procedure, a single natural orifice (the umbilicus or belly button) is used as     the single incision site through which the entire donor nephrectomy is performed. The LESS-DN     procedure may further decrease donor morbidity by further decreasing length of stay,     lessening recovery time, and improving satisfaction with the surgical scar. The investigators     propose to evaluate conventional LDN versus a LESS-DN in a randomized, controlled trial in     living kidney donors. The investigators will compare operative times and intra-operative     donor management, intra- and post-operative complications, pain scores, analgesic     requirements, length of stay, recovery parameters, surgical scar satisfaction, and function     and survival of the transplanted kidney for the two groups of subjects: (1) the group that     has the conventional laparoscopic donor nephrectomy; and, (2) the group that has the     laparoendoscopic single site donor nephrectomy.   "
156422|NCT01236313|"     The purpose of this study is to prospectively determine the relationship between the     dimensions of the aorta (the large artery taking off the heart) and blood pressure during     cardiac surgery.   "
156423|NCT01236300|"     Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy     (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous     from non-mucinous cysts)   "
156424|NCT01236287|"     Voclosporin is an investigational medication previously studied to prevent acute rejection in     patients who receive a kidney transplant. This study is a compassionate release program where     subjects previously participating in the study entitled A Phase 2B, Randomized, Multicenter,     Open-Label, Concentration Controlled, Safety Study of ISA247 and Tacrolimus (Prograf®) in     denovo Renal Transplant Patients (ISA05-01) may be eligible to continue to receive     voclosporin despite the Phase 2B study being terminated by the sponsor. Under the     compassionate release program, subjects previously taking voclosporin may continue to receive     the study medication until the drug is FDA-approved and commercially available in the United     States.   "
156450|NCT01235949|"     The aim of the current study is to determine whether ibuprofen, given as immediate or delayed     prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune     response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals'     10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3,     4 and 5 months of age.      In addition, this study will further evaluate the impact of prophylactic administration of     paracetamol following primary vaccination with immediate or delayed administration or when     given in an immediate manner at the time of the booster dose.   "
156451|NCT01235936|"     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of repeat     doses of orally administered AKB-6548 in pre-dialysis subjects with anemia.   "
172244|NCT00096837|"     The purpose of the study is to determine if the drug motexafin gadolinium will be an     effective treatment for patients who have relapsed or refractory multiple myeloma.   "
156454|NCT01235897|"     The purpose of this study is to test the safety and safest highest dose of an investigational     drug called MK-2206 when given in combination with paclitaxel and trastuzumab in patients     with Human Epidermal growth factor Receptor 2 (HER2)-overexpressing solid tumor malignancies.   "
156425|NCT01236274|"     A number of studies have suggested an association between the use of antipsychotic agents and     cardiovascular mortality. However, the relationship between cardiac events and the use of     antipsychotic drugs is not clear. Patients experiencing psychoses and in need for     antipsychotic agents may be at a higher risk of cardiac events regardless of any effect of     antipsychotic medication. Two studies have specifically investigated the association between     the use of antipsychotics and the risk of cardiac events using Myocardial Infarction (MI) as     an outcome measure, reporting no association and a positive association respectively. This     difference in results may be explained by the use of different measures as well as study     designs in both studies and because of different limitations with regard to controlling for     lifestyle and medical risk factors. This study aims to assess the relationship between the     risk of MI and recent exposure to antipsychotic agents by using the self-controlled case     series method with which we are able to control for fixed confounders. The results of the     self-controlled case series method will be compared to the results of a case-control study     using the same data to compare the estimates of both methods.   "
156426|NCT01236261|"     The aim of this study is to describe the epidemiology of fungal blood infections in Spain     (with emphasis on the incidence, fungal species distribution and antifungal susceptibility).     The study is to be performed in five big cities which represent different geographic areas:     Barcelona, Bilbao, Madrid, Sevilla and Valencia.   "
156427|NCT01236248|"     The purpose of this study is to determine a computer- and family-based drug abuse prevention     program is able to reduce drug use among early adolescent girls.   "
156428|NCT01236235|"     The purpose of this study is to describe long term (> 96 weeks) efficacy and safety of     Atazanavir-based regimens in real life setting.   "
156429|NCT01236222|"     The purpose of this study is to determine whether cycling to school is effective in the     prevention of the metabolic syndrome.   "
156430|NCT01236209|"     The overall objective of this randomized controlled study (RCT) financed by the Norwegian     Research Council (grant no. 182012/V50) is to establish the effectiveness of situational     feedback to the self-management of fibromyalgia syndrome (FMS) using innovative means of     patient-provider communication in a randomized controlled study (RCT). Thereby this project     will contribute to the knowledge of treatment of patients with FMS. The effectiveness of the     intervention will be expressed in terms of a) reduced pain, b) psychometric outcomes, c)     quality of life, d) improved engagement in daily activities and e) prevented transition to     chronic disability. We furthermore aim to 1) determine the effectiveness of providing regular     situational feedback in enhancing self-management and, consequently 2) study the     effectiveness of enhancing self-management in reducing pain and physical disability.      Self-management of chronic pain is increasingly seen as an important tool in providing     adequate care to patients with FMS and other types of Chronic Non-malignant Pain. Enhancing     the patient's self-management of her/his condition is thought to be effective in reducing     pain and disability. However, sufficient empirical evidence to support this is yet     unavailable. This may be due to the non-situational nature of many interventions studied so     far: Patients are taught management skills in a clinical setting, and may not be able to     successfully use these skills in daily care. Therefore, enhancing self-management of chronic     pain, by providing immediate feedback that is directly related to patient's daily life     (situational feedback) complementary to care-as usual, is thought to be more effective than     conventional interventions in a clinical setting. This may even be even more effective when     the patient receives quick response feedback using mobile communication technology, i.e. any     place any time.   "
156431|NCT01236196|"     We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior     therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain and     randomizing them into one of two treatment conditions. The study sample was recruited from     primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based     outpatient clinics (CBOCs) in downtown San Francisco, Clearlake, Eureka, San Bruno, Santa     Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved     muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction.     Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a     20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks     (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample     size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study     hypothesis, assessment methodology, and intervention procedures were based on the     cognitive-behavioral model of chronic pain.   "
156432|NCT01236183|"     To determine number of cases need to perform in new anesthesia residents to be proficient in     manual skills.   "
156433|NCT01236170|"     The Department of Veterans Affairs (VA) provides wheelchairs to about 42,000 Veterans with     SCI and more than 40,000 Veterans with amputated limbs (AL). Despite VA's efforts to remove     financial and other barriers to the provision of wheelchairs to all Veterans who need them,     preliminary evidence suggests that disparities exist in the quality of wheelchairs prescribed     to racial minorities and low income Veterans with SCI or AL. The proposed project will     provide important information to the VA about the quality and equity of wheelchairs provided     to Veterans with SCI or AL, and it will identify the patient and provider factors associated     with wheelchair provision. Because Veterans with SCI and AL are considered special disability     populations, identifying and understanding these factors is a critical first step to     developing interventions to increase the quality and equity of wheelchairs provided to all     disabled Veterans.   "
156434|NCT01236157|"     Support pre-hospital chest pain remains a difficult problem in both pre hospital regulation     that when supported by the Mobile Services Emergency and Intensive Care (SMUR).      This ground of appeal underlying various pathologies especially acute coronary syndrome whose     early care diagnostic and treatment significantly improves the prognosis.      The recognition and management of SCA is therefore a public health issue. Myocardial     infarction (MI) is responsible for 10 to 12% of the total annual mortality in adults and     coronary heart disease is the leading cause of death in France.      No studies have assessed the adequacy of regulation and management of chest pain SAMU for the     diagnosis of SCA.      The main objective of the research is to have a descriptive analysis of the population     controlled by the SAMU and the population served by the mobile emergency with chest pain.     Also evaluate the adequacy of the proposed direction by the ambulance SAMU/SMUR and the final     diagnosis and direction after passing emergency, cardiology and at follow-up to a year.   "
156452|NCT01235923|"     Preterm infants are a risk for multiple transfusions, and the administration of human     recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements. Dosing     usually occurs three times a week, but extended dosing schedules have been successful in     adults. The investigators assessed weekly Epo dosing in preterm infants compared to standard     three times weekly dosing.   "
180818|NCT00212043|"     Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation     and be more effective clinically in non-small cell lung cancer   "
156435|NCT01236144|"     The AML18 Pilot Trial will evaluate the feasibility of three interventions that are planned     to be included in the forthcoming NCRI AML18 Trial. One intervention will be to evaluate     combining the Tyrosine Kinase Inhibitor AC220 with three courses of standard DAE     (Daunorubicin, Ara-C, Etoposide). AC220 will be given following each treatment course, daily     by mouth for 7, 14 or 21 days. AC220 will be evaluated at 3 dose levels of 60, 90 and 135 mg     flat dose. A 4th dose level of 40 mg will be introduced should patients not respond well to     60 mg. The second intervention to be tested is the combination of the CXCR4 inhibitor     Plerixafor with up to three courses of the chemotherapy combination of DClo (Daunorubicin,     Clofarabine). Patients/investigators will be able to choose which intervention to enter.     Depending on recruitment requirements, only one intervention might be available at any one     time. The third intervention Patients will receive 3 treatments of 100 mg of ganetespib on     days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The     chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which     will be associated with 3 administrations of ganetespib.   "
156436|NCT01236131|"     The goal of this project is to identify the microorganisms present in the endometrial samples     obtained from women with or without evidence of endometritis using a combination of culture     methods, rRNA sequencing and whole genomic sequencing. The overarching aim of these studies     is to identify the etiology of endometritis. The investigators will define the role of     fastidious anaerobic microorganisms in the etiology of PID, and assess whether antibiotic     treatment regimens used for the treatment of PID have activity against the novel organisms     linked with pelvic infections.   "
156437|NCT01236118|"     The purpose of this study is to evaluate the safety and tolerability of LY2439821     subcutaneously administered for 48 weeks in Japanese participants with rheumatoid arthritis     who have completed Study I1F-JE-RHAL (NCT01253265).   "
156438|NCT01236105|"     The purpose of this study is to determine the effect of activated charcoal and dosing time on     the absorption of LY2624803 in healthy subjects. In this crossover study, there are three     treatments with a washout period of at least 7 days in between treatments. Each subject will     participate in all three treatments with random assignment to the treatment sequence.   "
156439|NCT01236092|"     The most common chronic low back pain conditions are a consequence of disc disease as well as     muscular and bony etiologies. The discs degenerate and weaken, bulge and are pushed into the     space containing the spinal cord or a nerve root resulting in severe pain. A common treatment     is then surgery. Whole-body vibration combined with un-weighting traction and specific manual     mobilization plus active therapeutic exercise seems to treat chronic low back pain by     non-invasively firing muscles of the lumbar spine. The investigators are seeking to show such     therapy reduces the need for surgery and significantly out performs traditional physical as     the preferred conservative treatment.   "
156440|NCT01236079|"     The goal of this patient-randomized effectiveness trial is to demonstrate that an inpatient     technology-supported assisted referral (I-TSAR) and follow-up approach is an effective and     cost-effective method to help hospitalized patients successfully quit smoking. The proposed     study represents a unique opportunity to assess the effectiveness and cost-effectiveness of     linking inpatient and outpatient delivery of smoking cessation services in two large and very     different health care delivery systems. We will enroll 900 participants (600 intervention,     300 controls) over 15-months and collect follow-up survey and health care utilization data     over 12 months to estimate: 1) smoking abstinence at 6 and 12 months for I-TSAR intervention     recipients compared to usual care; 2) the dose effect on smoking abstinence at 6 and 12     months for I-TSAR recipients compared to usual care; 3) total and mean costs per participant     for I-TSAR and usual care recipients, and, if effective, estimate the incremental     cost-effectiveness of the intervention vs. controls at 12 months from health plan/insurer and     societal perspectives; and 4) differences in health care utilization at 12 months for I-TSAR     versus controls.   "
156441|NCT01236066|"     This study aims to monitor the incidence rates and duration of hospitalisations for rotavirus     gastroenteritis (RV GE) and all cause GE, compared to bronchiolitis from 1998 to 2009, in     children < 5 years of age after the introduction of Rotarix in 2006 by year, both inside and     outside rotavirus season in Australia. It further aims to compare the two dose regimen of     Rotarix with the three dose regimen of RotaTeq from 2007 to 2009.   "
156442|NCT01236053|"     High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there     has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by     spontaneous reports in AERS or in the published literature. In a published case-control     screening study of the association of gabapentin with 55 cancers, the only cancer that met     the screening criteria for possibly increased cancer risk with gabapentin exposure was renal     (including renal pelvis) cancer. This association was judged to be likely due to or     substantially accentuated by confounding by cigarette smoking, hypertension, and lifestyle     (Cancer Causes Control 2009;20:1821-1835).      The relationship between gabapentin exposure and pancreatic cancer and renal cancer is     studied in NCT01138124, and supplemental analyses for these cancers are performed in the     current study. The FDA recommended GSK also study the relationship between gabapentin and     all-cancer sites, as well as cancer at the following specific sites: 1) stomach, 2) anus,     anal canal, and anorectum, 3) lung and bronchus, 4) bones and joints, 5) breast, 6) penis, 7)     urinary bladder, and 8) other nervous system.      The primary objective of this study is to determine whether exposure to gabapentin is     associated with an increased risk of developing all-cancer, and these specific cancers in the     United Kingdom (UK) General Practice Research Database (GPRD). Each member of the UK     population is registered with a General Practice, which centralizes the medical information     not only from the general practitioners themselves but also from specialist referrals and     hospital attendances. Over 487 General Practices contribute data to the GPRD.      The study cohort from which cases and controls are drawn is all subjects in the GPRD     1993-2008. Gabapentin was approved in the UK in May 1993. Entry into the study cohort begins     Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of     registration if later than Jan 1, 1993. Subjects are excluded from the GPRD cohort if they     have a cancer diagnosis or a history of cancer prior to the cohort entry date. Patients with     a first diagnosis of the respective cancer 1995-2008 are risk set matched with up to 10     controls within the same General Practice for age at cohort entry (within two years), sex,     and year of entry into the study cohort (within one year). For cases, the index date is the     date of first diagnosis of the respective cancer. The index date for controls is set as the     date at which the follow-up time from cohort entry is the same as the case. The index date is     chosen so as to give the control equal follow-up time to that of the case for ascertainment     of use of gabapentin. Cases and controls will be required to have at least 2 years of     follow-up in the study cohort before their index date. Cases must have no history of any     other cancer diagnosis prior to the index date. Controls are required to be free of cancer     diagnosis in the database up to the control's index date.      Data on gabapentin prescriptions are obtained for cases and controls from study cohort entry     to the index date. Gabapentin exposure will be assessed as ever/never, number of     prescriptions, cumulative dose, and cumulative duration, with a 2 year lag period     incorporated to control for protopathic bias (gabapentin prescription for initial pain     symptoms of undiagnosed cancer) and latency (time between cancer onset and specific GPRD     cancer diagnosis).      Crude and adjusted odds ratios and 95% confidence intervals (CI) will be produced from     conditional logistic regression models, with additional analyses evaluating for     dose-response. Covariates include indications for gabapentin use and risk factors for each     cancer.   "
156443|NCT01236040|"     This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate     vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.   "
156444|NCT01236027|"     Biologic samples are necessary for development and validation of laboratory procedures (e.g.     novel biological and analytical assays, explant tissue models, validation of specimen     collection and transport) to support future infectious disease clinical studies. In this     research study, the investigators will collect blood samples, vaginal swabs, cervical swabs,     mucus/vaginal discharge, cervicovaginal lavages, vaginal and cervical biopsies, as necessary,     to use in the development of laboratory processes. The investigators will obtain the     sample(s) from healthy HIV negative women. Samples will be collected and sent to Magee-Womens     Research Institute as laboratory specimens are needed.   "
156445|NCT01236014|"     An indirect comparison to compare the efficacy of eltrombopag versus romiplostim   "
156446|NCT01236001|"     Observational study at the request of the Belgian Institut National d'Assurance     Maladie-Invalidité / Rijksinstituut voor Ziekte-en Invaliditeits Verzekering INAMI/RIZIV:        -  type of patient treated with VIMPAT®        -  VIMPAT® dose        -  Effect of VIMPAT® on evolution of seizure control        -  Persistence rate at 6 months in terms of treatment duration        -  Discontinuation rate        -  Description of any changes in other epilepsy therapies        -  Safety and tolerability   "
156447|NCT01235988|"     The purpose of the meta-analysis was to explore the efficacy of eltrombopag versus placebo     (standard of care)   "
156448|NCT01235975|"     This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK     134612 given as single dose to healthy adults 56 years or older compared to the meningococcal     polysaccharide vaccine MencevaxACWYTM.   "
156449|NCT01235962|"     This randomized Phase III study is to evaluate whether pazopanib compared with placebo can     prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of     developing recurrence after undergoing kidney cancer surgery   "
156455|NCT01235884|"     Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days of     life can reduce the onset of gaseous colic in neonates and the onset of minor digestive     disorders such as regurgitation and constipation.      Study Design. Double blind, randomized, controlled, multicenter study. 492 neonates of 37-42     gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or     placebo for 28 days.      After the inclusion, at baseline will be performed :        -  Paediatric visit        -  antropometric valutation        -  number of the daily crying minutes, number of regurgitation and number of daily          evacuation      The patients will receive the probiotics/placebo every days for 28 days and the 29th will be     repeated the following analyses:        -  Paediatric visit        -  antropometric valutation        -  number of daily crying minutes        -  numbers of regurgitation        -  numbers of evacuations      Primary outcome :      To define if Lactobacillus reuteri supplementation can reduce the onset of gaseous colic,     regurgitation and of constipation.      Inclusion criteria        -  neonates of 37-42 week gestational age and appropriate birth weight        -  Recruitment age: until 7 days of life        -  Informed consent signed      Exclusion criteria        -  Presence of other gastrointestinal diseases.        -  Use of FANS, aspirin or other drugs        -  Use of antibiotics and/or PPIs e/o anti-H2        -  Participation to other clinical trials   "
156456|NCT01235871|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics of SB1578 in healthy volunteers.   "
156457|NCT01235858|"     There is an increasing trend in the incidence of infection related to epidural anesthesia.     This could be related to methods of aseptic technique as adopted by the anesthesiologist     during the performance of the procedure.      The purpose of this study is to compare two methods of aseptic technique for labor epidural     insertion; a conventional method without wearing a sterile gown (free from living germs or     microorganisms) versus strict aseptic method with wearing of sterile gowns.      It is our belief that there will be an increased contamination of epidural equipment and     colonization of epidural catheter, secondary to bacterial fallout from the operators' bare     hands in the group not wearing the sterile gowns.   "
156458|NCT01235845|"     Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis     carries with it a median survival of approximately 12 months, with 90 - 95% of patients     surviving less than 2 years. The current standard treatment of surgical resection followed by     radiation therapy and chemotherapy has not substantially prolonged survival.      Dendritic cells (DCs) are immune cells that form part of the mammalian immune system. Their     main function is to process antigen material and present it on the surface to other cells of     the immune system, thus functioning as antigen-presenting cells.In the present study, DCs     were used for antigen presentation of glioma antigens to directly induce a cytotoxic T-cell     response. Cytokine-induced killer (CIK)cells are shown to be a heterogeneous population, and     the major population expresses both the T cell marker CD3 and the NK cell marker CD56, and is     termed NKT cells, which has shown significant anti-tumor activity in both clinical trials and     animal studies.      Furthermore, CIK cells are able to expand significantly when they are cultured with DCs, and     the CIK cells activated by DCs stimulation (DCIKs)have a characteristic which cytotoxic     activity enhanced and show increased anti-tumor activity.      This study aimed to evaluate the clinical efficacy of DCIK cells treatment combined with DCs     following tumor resection and radiotherapy in patients with malignant glioma.   "
156459|NCT01235832|"     The investigators propose to evaluate the effects of avocado consumption (by incorporating 1     unit of fruit per day into a healthy diet) on multiple cardiovascular disease (CVD) risk     factors. The investigators will compare chronic consumption of a moderate fat blood     cholesterol-lowering diet incorporating one avocado per day versus a blood     cholesterol-lowering Lower-Fat diet on established CVD risk factors including lipids and     lipoproteins, and blood pressure (BP). The investigators also will evaluate the effects of an     avocado diet on several emerging CVD risk factors. To elucidate the specific benefits of     avocado and its accompanying bioactives on the aforementioned risk factors, the investigators     will compare the avocado diet with a diet that has the same macronutrient profile (but     without the avocado).   "
156460|NCT01235819|"     To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1     diabetes patients.   "
156476|NCT01235598|"     Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic     Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials     (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.   "
156477|NCT01235585|"     This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will     evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally     controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will     be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks,     followed by an optional treatment extension for up to 3 years.   "
156478|NCT01235572|"     This phase II trial studies how well early discharge and outpatient care works in patients     with myelodysplastic syndrome or acute myeloid leukemia previously treated with intensive     chemotherapy. Gathering information about patients with myelodysplastic syndrome or acute     myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital     until blood counts return to normal, may help doctors learn more about the safety of allowing     patients to leave the hospital early, the patient's quality of life, use of medical services,     and the cost of these services associated with such a policy.   "
159311|NCT01198392|"     The purpose of this study is to evaluate the effectiveness and safety of s-1 plus cisplatin     versus 5-FU plus cisplatin as first-line therapy in the treatment of patients with advanced     gastric cancer.   "
156479|NCT01235559|"     This randomized, multi-center double-blind, parallel-group, placebo-controlled study will     evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally     controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will     be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks,     followed by an optional treatment extension for up to 3 years.   "
157563|NCT01221285|"     This trial is a biomarker-based pilot study of the safety of Cockroach Subcutaneous     Immunotherapy in Cockroach-sensitive Adults (SCITCO) who have a history of perennial allergic     rhinitis, asthma, or both.   "
156461|NCT01235806|"     The Alpes Maritimes county administration (France) equipped Nice University Hospital of a     0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the     medical imaging unit.      The aim of our project is to study its interest in diagnosis of scaphoid fractures.      Conventional medical care for patients being suspected to have a scaphoid fracture consists     in performing a clinical examination and a radiographic check-up with at least 4 incidences,     which 2 specific incidences for the scaphoid bone.      Yet, this check up is sometimes defective, causing false positives unnecessary immobilisation     and false negatives delays in patient medical care, increasing the risk of complication.     Those diagnosis mistakes can bring serious consequences, from permanent partial inability, to     professional reclassification.      Alternative imaging exists, but is often irradiating, and never reaches the optimal     specificity and sensitivity.      MRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of     cases. The problem is the lack of accessibility for emergency cases; therefore there is a     great interest in validating the use of a MRI dedicated to distal articulations.      The few studies that study costs of diagnosis strategies including MRI in scaphoid bone     fractures diagnosis show a reduction of medical costs if this technique is used early. Our     project represents an essential initial step in evaluating the impact of a low field MRI     dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will     be a medico-economical study, since scaphoid fractures occur frequently.      Finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.   "
156462|NCT01235793|"     The primary purpose of the study will be testing the dosing of temozolomide to find the     target dose that a person can tolerate. The other part of the study will be determining how     helpful it can be to CNS lymphoma patients by adding temozolomide to the conditioning     regimen prior to stem cell transplantation.      This research study is designed to test the investigational use of temozolomide as part of a     conditioning regimen prior to stem cell transplantation. This drug has not yet been approved     by the U.S. Food and Drug Administration (FDA) to be used in the setting of stem cell     transplantation in lymphomas of the brain (central nervous system or CNS) but it has been     studied and used before in transplantation with reasonable results.   "
156463|NCT01235780|"     The purpose of the study is to investigate the factors affecting corneal hysteresis (CH) in     Taiwanese.   "
156464|NCT01235767|"     The purpose of this study is to determine if a nutrient-rich supplement of animal-source     foods ingested 5d/wk from pre-conception to term improves maternal nutrient status, decreases     infections, and improves birth weight and rates of prematurity compared with supplemental     ingestion during pregnancy ( from mid-gestation to term) or routine prenatal care.   "
156465|NCT01235754|"     The objective of this study is to evaluate the persistence of benefit of LibiGel     (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of     Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.   "
156466|NCT01235741|"     Following screening, eligible subjects will be enrolled into a 6‑week Low Calorie Diet (LCD)     lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week     LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or     placebo) to begin a 16-week treatment period during which the effect on body weight of     treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week     blinded core treatment period, subjects will discontinue study medication for a period of 12     weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate     a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week     off-drug and 12 week open label treatment periods, subjects will continue to participate in a     Lifestyle Intervention (LSI) program.   "
156467|NCT01235728|"     This is a within-participant comparison study to investigate the efficacy of a 28-day regimen     of MK-0873 2% cream twice a day (b.i.d.) compared to MK-0873 vehicle (matching placebo)     b.i.d. as well as to a positive control comparator calcitriol 0.0003% (3 µg/g) in     participants with plaque psoriasis. In order to be enrolled in the study, patients need to     have at least two pairs (lesions AB and CD) of approximately similar plaque lesions in     severity and size of surface area involved and located in approximately symmetric regions     such as the trunk or limbs of the body. Participants will be randomly assigned to apply     either MK-0873 or MK-0873 vehicle to plaque A or B and will be randomly assigned to apply     MK-0873 or calcitriol to plaque C or D. It is hypothesized that MK-0873 cream formulation     administered to participants with psoriasis by the topical route will result in a     statistically greater percent target lesion severity (TLS) reduction in plaque lesion than     will MK-0873 Vehicle on Day 29.   "
156468|NCT01235715|"     Application of Evicel hemostatic matrix during operation for unilateral total knee     replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a     reduction in transfusion requirements, and less reduction of hemoglobin.   "
156469|NCT01235702|"     A 12-week treatment/control trial was implemented to assess the effects of a multi component     lifestyle program on improvements in body mass index, weight, perceived stress and blood     pressure in African American men and women who were at increased risk for cardiovascular     disease. It was hypothesized that treatment group would experience significant improvements     when compared to the control group.   "
156470|NCT01235689|"     Efficacy and Safety of two treatment models in subjects with moderate to severe Crohn's     Disease.   "
156471|NCT01235676|"     0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle     intervention during pregnancy   "
156472|NCT01235663|"     0-hypothesis: advisory support does not        1. prolong the the breast-feeding period        2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers   "
156473|NCT01235650|"     This is a retrospective chart review of patients undergoing spinal fusion surgery to see the     prevalence of hyperventilation.   "
156474|NCT01235637|"     The main objective is to assess the efficacy of Alfentanil for pain in children treated by     tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the     current standard treatment.   "
156475|NCT01235624|"     Identify new genes responsible for autosomal dominant retinitis pigmentosa (ADRP), one of the     most common causes of hereditary diseases of the retina, and thus better understand the     mechanisms involved of the disease.   "
156480|NCT01235546|"     The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic     multi-center randomized clinical trial designed to evaluate the comparative effectiveness and     safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus     standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin     (preferably prior to surgical incision) to prevent post-cesarean infection.      Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if     cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum     prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.   "
156481|NCT01235533|"     To investigate whether fish oil supplementation, compared to placebo (olive oil), could have     better effects on depression course and cognitive function in older people with major     depression.   "
156482|NCT01235520|"     This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will     evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled     symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be     randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks,     followed by an optional treatment extension for up to 3 years.   "
156483|NCT01235507|"     This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra     (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe     rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic     drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800     mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued     at a stable dose. Anticipated time on study treatment is 24 weeks.   "
156484|NCT01235494|"     To develop techniques with MRI of Helium-3 gas to give functional images of the lungs. The     goal is to test a single breath-hold functional 3-He MRI pulse sequence with sensitivity to     multiple functional aspects of the luncg physiology. A group of 20 healthy volunteers willbe     recruited from the local research group and the results compared with existing methods that     require seperate breath-holds of 3He gas   "
156485|NCT01235481|"     The Public Health Agency of Canada estimates that over 3.5 million Canadians live with     chronic respiratory diseases, such as COPD (chronic bronchitis and emphysema), asthma, sleep     apnea, and lung cancer. Nova Scotia has been reported to have one of the highest rates of     chronic lung disease among Canadian provinces, likely a reflection of both the age of the     population and high rates of exposures to occupational dusts and smoking. Pulmonary     rehabilitation is a multidisciplinary intervention, involving exercise and education for     patients with chronic lung disease. Pulmonary rehabilitation has been demonstrated to improve     patient symptoms, exercise capacity, and quality of life while reducing health resource     utilization. Many studies have shown that the benefits of pulmonary rehabilitation tend to     diminish over time after program completion. The best interventions to maintain the benefits     of pulmonary rehabilitation remain unclear.      The purpose of this study is to validate incorporation of an exercise DVD into a maintenance     program after pulmonary rehabilitation. 100 subjects will be recruited over 2-years from     pulmonary rehabilitation programs at Capital Health, with 50 individuals randomized to usual     care following PR and 50 individuals randomized to usual care plus the exercise DVD. Study     subjects will be evaluated at time of enrolment in pulmonary rehabilitation, at completion of     pulmonary rehabilitation and 6-months post- pulmonary rehabilitation. Study outcome measures     will include exercise capacity, exercise compliance, health-related quality of life,     confidence with performing exercise, and satisfaction with the exercise DVD. The primary     outcome measure will be a change in functional exercise capacity as determined by the     distance walked in 6-minutes, a commonly used and validated assessment tool for patients with     chronic lung disease.   "
156486|NCT01235468|"     The aim of this study is to evaluate the safety profile and tolerability of infusion of cord     blood cells expanded in the lab and to evaluated whether through the infusion of expanded     cells it is possible to expedite engraftment time after transplantation.   "
156487|NCT01235455|"     This is an observational survey to assess the factors that influence adherence to Betaferon     therapy in multiple sclerosis patients using elements of the BetaPlus support program,     including the nurse support and auto-injectors. The patients were evaluated under normal     clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping     processes (WCQ) and depression questionnaire CES-D.   "
156488|NCT01235442|"     The primary hypothesis of this trial is that the addition of short courses of clobetasol     propionate foam to etanercept monotherapy in subjects with moderate to severe plaque     psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by     PASI 75 at Week 12.   "
156489|NCT01235429|"     Type 2 diabetes is common among Native Hawaiians and Pacific Peoples. Diabetes related     complications decrease quality of life and can result in early morbidity. The purpose of the     Partners in Care diabetes self-management educational intervention is to teach participants     how to manage their diabetes to avoid or delay diabetes-related complications and how to     better work with their health care team.   "
156490|NCT01235416|"     This study is an open-label, dose-finding study to determine the target or maximum-tolerated     dose and to characterize the safety and pharmacokinetic profile of AMG 706 administered in     combination with erlotinib with or without gemcitabine in subjects with solid tumors.   "
156491|NCT01235403|"     To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of     400 mg/day, or to a clinically effective lower dose for an individual patient, improves the     tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients     with partial onset epilepsy.      Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility   "
156492|NCT01235390|"     The purpose of this study is to determine the effects of the 4-week consumption of California     walnuts on vascular function and immune health in postmenopausal women of ages 50-70.      Primary outcome measures:        -  vascular endothelial function        -  platelet reactivity        -  indoleamine 2, 3-deoxygenase (IDO)      Secondary outcome measures:        -  relationship of walnut intake to lipoprotein, fatty acids and oxylipins   "
156533|NCT01234857|"     This is a two-part study that will determine, if: 1) the combination of ridaforolimus and     dalotuzumab will improve progression-free survival compared to exemestane; and 2) the     combination of ridaforolimus and dalotuzumab will improve progression-free survival compared     to both ridaforolimus and dalotuzumab as single agents, in participants with breast cancer.   "
180819|NCT00212056|"     To evaluate whether ANP as an adjunctive therapy for AMI reduces myocardial infarct size and     improves regional wall motion.   "
156561|NCT01234493|"     The aim of our study was to determine whether transfixation of unstable syndesmosis is     necessary in supination-external rotation type ankle fractures. Our hypothesis was that     syndesmotic ligaments heal at the proper length after malleolar reduction and that     syndesmotic transfixation is not needed in supination-external rotation fracture types.   "
156493|NCT01235377|"     This is a pilot study of a method to compare common, FDA-approved drugs in a clinic. Instead     of putting single patients into one of two drug groups, the investigators will assign the     doctors who prescribe these drugs for high blood pressure into two groups. One group of     doctors has agreed to prescribe mostly (favor) one drug, chlorthalidone, if that drug would     be a good choice for a patient. The other group has agreed to prescribe mostly     hydrochlorothiazide. For both groups, they will try to use the doses that were shown to be     protective in other trials. If the doctors mostly prescribe the drug they agreed to favor,     the investigators will be able to compare outcomes, like heart attacks, in the two groups.   "
156494|NCT01235364|"     The purpose of this study is to assess pain in women randomised to digital or speculum     placement of a Foley catheter. Pain during cervical ripening with the Foley catheter is also     to be evaluated as well as maternal satisfaction with induction of labour.   "
156495|NCT01235351|"     To determine whether higher as compared with lower maintenance doses of clopidogrel can     adequately improve the degree of platelet inhibition in carriers of a reduced-function     CYP2C19 allele.   "
156496|NCT01235338|"     This study will examine the effects of co-administration of SPD489 and the antidepressant     EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In     addition, serial blood pressure and pulse measures will be obtained and examined to ensure     that there are no unexpected changes in vital signs following co administration of SPD489 and     EFFEXOR XR that would impact the further study of this drug combination. The hypothesis is     that a drug drug interaction could possibly exist.   "
156497|NCT01235325|"     To assess the impact of a 12 month vitamin K supplementation intervention on bone health in     adult Crohn's disease patients   "
156498|NCT01235312|"     Currently, dorsal hand rejuvenation is an upcoming issue as patients seek plastic surgeons to     address this highly visible area, although no specific statistics concerning the number of     patients undergoing dorsal hand rejuvenation have been published yet. The solitary use of     fillers, fat, sclerotherapy, skin excision, resurfacing and combinations of the above     mentioned therapies have been reported in the literature, but still there is a lack of     scientific literature about functional microcirculation of the dorsum of the hand.      Furthermore, there is a lack of scientific data about functional microcirculation of the     plantar foot in healthy subjects compared to patients suffering from Diabetes mellitus or     peripheral arterial occlusive disease. Consequently, the aim of this study is the evaluation     of the functional microcirculation of hands and feet in healthy subjects as well as patients     suffering from the above mentioned diseases.   "
156499|NCT01235299|"     In case of free flap failure, time is of utmost importance as salvage rates have been     reported to be inversely related to the time interval between the onset of ischemia and its     clinical recognition. Consecutively, monitoring of free flaps remains of major importance.     Currently, combined Laser-Doppler and Spectrophotometry is available to determine     microcirculation of free flaps in reconstructive surgery as a scientific method of reliable     assessment of flap perfusion. The investigators thought to analyze the correlation of free     flap skin temperature and free frap microcirculation as an accurate tool of postoperative     flap monitoring.   "
156500|NCT01235286|"     Background: In plastic and reconstructive surgery, free flaps are routinely used for     treatment of soft tissue defects. Treatment strategies aim at reducing or preventing flap     necrosis by conditioning tissue tolerance against ischemia. Although previous studies     indicate that remote ischemic preconditioning (RIPC) is a systemic phenomenon, only a few     studies have focused on the elucidation of its mechanisms of action. Therefore, the aim of     this study is to evaluate the microcirculatory effects of remote ischemic preconditioning on     a potential free flap location in a human in-vivo setting for the first time.      Conclusion: Remote ischemic preconditioning improves cutaneous tissue oxygen saturation,     arterial capillary blood flow and postcapillary venous flow in a remote free flap donor     location. To what extent remote preconditioning might ameliorate the reperfusion injury of     free flap transplantation, further clinical trials have to evaluate both in the means of     microcirculatory assessment and partial or total flap loss as end points of these studies.   "
156501|NCT01235273|"     The objective of the study is to determine whether treatment of the low IGF-1 syndrome in     patients with CHF is able to modify some functional parameters, recognized as valid surrogate     end-points of CHF progression.   "
156502|NCT01235260|"     The purpose of this study is to evaluate risk of cancer incidence and mortality associated     with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U.S.     Veterans Health Administration.   "
156503|NCT01235247|"     Computer-generated clinical reminders offered to providers will improve compliance with care     guidelines and impact outcomes in resource-limited clinics.   "
156504|NCT01235234|"     Eligible patients with dry eye will be treated with CF101 or placebo twice daily for 24     weeks. Disease activity will be assessed using evaluations of ocular surface integrity, tear     production, and patient symptoms.   "
156505|NCT01235221|"     The primary objective of the study is to evaluate the long-term safety and tolerability of     BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple     sclerosis (MS) who previously participated in the registrational and extension studies     conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT)     and NCT00649792 (MS-F204EXT).   "
156506|NCT01235208|"     The background for the trial is a number of previous studies indicating that it is especially     important to restrict the intake of carbohydrates when treating overweight and metabolic     diseases in general.      The purpose of the study is to obtain research data on the effects of an established     treatment of overweight/obesity and its related metabolic disorders. The treatment, Dr.     Fedon Lindbergs Vektcoach, is a combination treatment where patients use low carbohydrate     and low energy Eurodiet products in the initial phases. After the initial phases are     completed, low glycemic normal foods are added to the diet until a sustainable and healthy     diet is achieved. The treatment is of 7 month duration.   "
156507|NCT01235195|"     This study is designed to determine differences in drug exposure in subjects after being     administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after     administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.   "
180838|NCT00212537|"     Gene and protein bank to study disease modifying and susceptibility genes and proteins in     urban patients with asthma.   "
156508|NCT01235182|"     Acute heart failure is one of the main causes of acute respiratory distres in prehospital     emergency setting. The early and correct diagnosis is important because the misdiagnosis can     result in deleterious consequeance to patients. Rapid bedside tests (like NT-proBNP) and     point-of-care lung ultrasound could be useful methods in field. This study confirmed that the     combination of ultrasound sign in combination with rapid NT-proBNP test has a hibh diagnostic     accuracy in differentiating between cardiac and pulmonray causes of acute dyspnea in the     field and the tretament possibilities in clinical obscure cases are mainly improved.   "
156509|NCT01235169|"     This is an open multicenter study, evaluating a new operative technique in femur neck     fractures. The treatment consist of augmentated nails in cases of subtrochanteric or inter     fracture due to osteoporosis.There two routine surgical techniques in femoral neck fractures:        1. Insertion an intramedullary nail (without augmentation) to the bone.        2. insertion a nail and metal plateto the bone. The major disadvantage of these methods is          the relative high rate (4-10 precentages) of failure because of the femur head bone          which is very brittle and osteoporotic.      This new approach enables the nail a better grip as a result of the cement augmentation which     consists of PMMA (Polymethyl methacrylate).      The investigators main goal is to evaluate the use of this surgical technique   "
156510|NCT01235156|"     Arrhythmia is a common disease that may be caused by various cardiovascular diseases.     According to statistics, 500,000 people die of severe arrhythmia every year in China, In the     United States, approximately 540,000 patients die each year.This study will evaluate the     effectiveness safety of sulcardine sulfate tablets in the patients with premature ventricular     contractions (and non-sustained VT).   "
156511|NCT01235143|"     Sevoflurane is the volatile anesthetic agent of choice in pediatric surgery. Nevertheless,     sevoflurane anesthesia had the high incidence of emergence delirium compared to halothane and     isoflurane.Bortone L et al.reported isoflurane for maintenance decreased incidence of     emergence agitation compared to sevoflurane in unpremedicated preschool children under     elective subumbilical surgery (32% versus 52% respectively). Desflurane is the new volatile     anesthetic agent which provides faster recovery compared to sevoflurane.Valley et al.reported     no significant differences between sevoflurane or desflurane anesthesia in children in term     of the serious airway complication such as laryngospasm or desaturation excepted the number     of coughing episodes were more frequent in the desflurane compared to sevoflurane (36 versus     18).Mayer J et al. reported sevoflurane had severity of Pediatric Anesthesia Emergence     Delirium (PAED) scale higher than desflurane in ear, nose, throat inpatient surgery in     children (12(2-20) versus 6(0-15) respectively) with no reported of incidence of emergence     agitation between those two. Therefore, the investigators would like to compare the incidence     of emergence agitation, recovery profile and respiratory events between desflurane and     sevoflurane anesthesia in pediatric ambulatory urologic surgery under general anesthesia and     combined with regional anesthesia.   "
156512|NCT01235130|"     The general objective of this study is to demonstrate the effectiveness of n-3 fatty acids,     2.4 grams per day, to prevent recurrence of atrial fibrillation in patients with paroxysmal     or persistent AF in whom a rhythm-control strategy is planned.   "
156513|NCT01235117|"     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying the side effects of azacitidine and to see how well     it works in treating patients with chronic myelomonocytic leukemia.   "
156514|NCT01235104|"     The aim of this study is to investigate the outcomes of total nephrectomy on patients with     kidney stone disease.   "
156515|NCT01235091|"     Women Teaching Women (WTW) is proposed by a team of Washington University investigators who     have focused on HIV prevention efforts among out-of-treatment injecting drug users (IDUs) and     crack cocaine users, since 1988. Our peer-delivered prevention model was successful in     reducing cocaine use among men. The investigators believe no differences were found in drug     and sexual risk behaviors for women because the intervention lacked gender-specificity. Thus,     the investigators propose to tailor our previous intervention to women's needs to determine     the shorter and intermediate term effectiveness of a gender-specific model on reducing drug     use and sexual risks. The urgency for women-focused interventions is highlighted by     increasing HIV/STD rates among women nationwide. The intervention is designed to bring the     HIV prevention message to women in a public health environment. The three-arm intervention,     which targets out-of-treatment drug-using women, will assess the differential impact of a     woman-centered standard intervention alone, the same standard intervention plus a well-woman     exam, and those plus the addition of 4 educational sessions. This proposal responds to two     NIDA PAs: 95-083 (Women's HIV Risk and Protective Behaviors) and 96-018 (Drug Abuse     Prevention Intervention for Women and Minorities). Our risk reduction, epidemiological and     technology transfer aims include:      Risk Reduction Aims:        1. Recruit out-of-treatment female drug injectors, heroin, crack/cocaine and          methamphetamine users to into an intervention aimed at reducing high risk sexual and          drug use behaviors. Street outreach, bars and clubs, shelters, health fairs and daycare          facilities will be used to reach these vulnerable women at risk.        2. Administer a modified theory-based, peer-delivered, gender and culture-specific          intervention that encourages women to reduce their high risk drug and sexual behaviors.          Women will be randomly assigned to one of three peer-delivered interventions: a modified          NIDA Cooperative Agreement Standard Intervention (SI), the SI + Well-Woman Exam          (SI+WWE), or the SI+Well-Woman Exam + 4 Educational Sessions (SI+WWE+4ES). The Standard          Intervention will be delivered by peers; the Well-Woman Examination will be conducted by          a nurse practitioner; the four 2 hour educational sessions will be conducted by peer          facilitators from area drug treatment programs paired with a community mental health or          health professional.        3. Assess the effectiveness of the interventions in reducing drug and sexual risk at 4 and          12 months post-intervention, controlling for baseline characteristics.        4. Evaluate the relative cost-effectiveness of each intervention.           Epidemiologic Aim:        5. Assess: a) incidence of HIV, Hepatitis B and C, syphilis, chlamydia and gonorrhea 12          months post-intervention; b) change in HIV risk and drug and alcohol use at 4 and 12          months post-intervention; c) the effect of psychopathology on behavior change at 12          months post-intervention; d) lifetime history of substance abuse and service utilization          for mental and physical problems at baseline.           Technology Transfer Aim:        6. Disseminate findings to the scientific community, practitioners and community members in          formats that are appropriate, understandable, and usable in order that the best possible          women-centered intervention can be developed for reducing HIV risk behaviors. The          investigators propose to create a WebSite and present findings at local, national and          international symposia. Manuals describing the interventions will be developed and made          available to the field.   "
156516|NCT01235078|"     The purpose of this study is to evaluate the use of powered intraosseous vascular access     (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular     access. Data collected will be compared to historical data on central venous catheter use in     the emergency department. The primary hypothesis is that powered intraosseous vascular access     will decrease the amount of time needed to obtain vascular access.   "
156517|NCT01235065|"     The purpose of this study is to assess if the GlideScope video laryngoscope is superior to     the Macintosh direct laryngoscope for definitive airway management in acutely-injured     patients.   "
156518|NCT01235052|"     Head and neck cancer is the sixth most frequent cancer worldwide, excluding lymphomas and     skin cancer. If 18FDG PET is considered today as a standard tool in patients with head and     neck squamous cell carcinoma (HNSCC) not only for tumoral or nodal staging but also for     assessment of distant metastases and synchronous second primary malignancies, hypoxia is one     of the most important prognostic factors in radiotherapy of this type of tumors. The only     gold standard method for direct determination of oxygen tension is based on using oxygen     electrodes showing a good relation with clinical outcome but complex in its realisation. So,     PET using 18F-FMISO has been described to be useful for the non invasive assessment of     hypoxia in cancer. Especially in France, the use of this radiotracer is very limited and     there is no standardised methodology to acquire and quantify 18F-FMISO signal. So there is a     need for a rigorous evaluation of this PET tracer. In another way, it could be a very useful     tool for evaluation of new therapies and modification of volumes in radiotherapy.   "
156519|NCT01235039|"     The primary objective of this study is to test for bioequivalence of VIAject®7 and VIAject®25     and to compare the pharmacokinetic/Pharmacodynamic/tolerability characteristics of VIAject®7     with those of VIAject®25 and insulin lispro.   "
156520|NCT01235026|"     The purpose of this study is to determine whether the daily administration of a synbiotic     (oligofructose and Bifidobacterium animalis subsp. lactis Bb12) for six weeks contributes to     improve the glucose tolerance and the low grade inflammation (as reflected as the plasmatic     concentrations of ultrasensitive CRP, IL-6, sCD14 and LPS-binding protein) in obese subjects.   "
156532|NCT01234870|"     The purpose of the study is to assess the diagnostic performance of fully automated motion     corrected (MC) first pass myocardial perfusion MRI, compared to the original non-corrected     first pass myocardial perfusion images in a cohort of patients with suspected ischemic heart     disease, using coronary angiography as the reference standard. It is expected that this     improved comprehensive protocol for cardiac MRI be accurate at detecting significant coronary     artery disease and may obviate the need for other more expensive and invasive diagnostic     tests currently used.   "
156521|NCT01235013|"     Maraviroc is an antiretroviral drug that belongs to the family of the CCR5 coreceptor     inhibitors. It has proven to be effective in increasing CD4 lymphocyte counts in both in     treated and naïve patients, irrespective of the viral load.      The investigators hypothesize that adding Maraviroc to the antiretroviral treatment of     discordant patients, defined as those having CD4 lymphocyte counts below 200 cells /mm3     during the last year, could lead to its immunological recovery.      60 patients will be included in this unicentric, prospective, randomized and stratified     clinical trial. They will be randomized to either continue with its usual high activity     antiretroviral therapy (HAART) treatment or to receive 300 mg of Maraviroc every 12 hours     plus its usual treatment. After 24 weeks, lymphocyte counts will be assessed, as well as     safety, clinical progression, immunological profile of the patients and the potential benefit     of Maraviroc for HIV+ cirrhotic patients.   "
156522|NCT01235000|"     Each winter, viruses belonging to two kinds of influenza A (A/H1N1 & A/H3N2) and two     kinds of influenza B (B/Yamagata & B/Victoria) can cause illness. The yearly influenza     vaccine is designed to protect against both kinds of influenza A but only one or the other     kind of influenza B. Current recommendations in Canada are that if an eligible child less     than nine years of age has received two doses of influenza vaccine before, then that child     only requires a single dose of influenza vaccine in subsequent years of immunization. In a     previous study conducted in early 2010 we measured the antibody response to influenza B in     children who had previously received two doses of a B/Yamagata kind of virus contained in the     2008-09 influenza vaccine and just one dose of the B/Victoria kind of virus contained in the     2009-10 recommended vaccine. The purpose of this follow-up study is to see if the protection     (antibodies in the blood) provided against the influenza B/Victoria kind of virus that was in     the 2009-10 vaccine can be improved with another (second) dose of the same B/Victoria kind of     virus included in the 2010-11 vaccine. Since influenza B is an illness especially of     children, understanding how to best protect children against both kinds of influenza B is     important.   "
156523|NCT01234987|"     The purpose of this study is to collect breath samples from healthy and cancer sick patients.     The breath, collected to special bags, will be transferred to laboratories in the Technion     and analyzed using an electronic nose system developed in Hossam Haick's labs (Chemical     Engineering, Technion). The hypothesis is that based on the analysis of the chemical     bio-markers present in the exhaled breath, cancer states can be distinguished from healthy     subjects or before and after treatment, allowing a technique for diagnosis of cancer and/or     cancer treatment.   "
156524|NCT01234974|"     Observe the safety/tolerability and effectiveness in terms of response rate and duration of     response of the combination pasireotide + everolimus in the treatment of patients with     relapsed/refractory multiple melanoma.   "
156525|NCT01234961|"     This project evaluates the outcomes of a work rehabilitation program, Redesigning Daily     Occupations (ReDO), for women with stress-related disorders. The ReDO intervention focuses on     how people compose their everyday lives. The basic idea is that re-structuring of an     individual's lifestyle and pattern of daily occupations will lead to a healthier balance     between the occupations of everyday life, and that this balance will promote wellness and     increased work capacity. The program is group based and comprises 16 weeks.      The aim is to evaluate ReDO for women with stress-related disorders. The project, which     covers the time period from entering the program to a 12-month follow-up, is a     quasi-experimental study. 42 women who entered the program and fitted the selection criteria     were included. A matched comparison group was selected among those clients at the Social     Insurance Office who get care-as-usual (CAU). Both groups are followed prospectively and     are compared regarding return to work, sick leave, and different aspects of health and     well-being. The hypothesis is that the ReDO group will improve more than the CAU group in all     these respects.   "
156526|NCT01234948|"     The primary aim of the current study was to determine the association between halitosis     detection (presence or absence) and periodontal status in non-smoking subjects, and also     assess whether halitosis recordings were related to periodontal clinical parameters, tongue     coating and quantities of two putative periodontal pathogens on the posterior region of the     tongue determined by real-time PCR. Secondary, halitosis recordings were compared among     subjects with chronic periodontitis, chronic generalized gingivitis and periodontal health.   "
156527|NCT01234935|"     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. It is not yet known whether giving dasatinib together with     gemcitabine hydrochloride is more effective than gemcitabine hydrochloride alone in treating     pancreatic cancer. PURPOSE: This randomized phase II trial is studying how well giving     dasatinib together with gemcitabine hydrochloride works compared to giving gemcitabine     hydrochloride alone in treating patients with pancreatic cancer previously treated with     surgery.   "
156528|NCT01234922|"     RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help     lower blood pressure.      PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril,     ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.   "
156529|NCT01234909|"     Atopic dermatitis is a chronic skin disease with pruritus as one of its main features.     Because of the symptomatic nature of their condition, pediatric patients with atopic     dermatitis may preferentially seek care in the subspecialty dermatology clinic while falling     behind in visits to their primary care provider. This cross-sectional study in patients     attending the Dermatology Clinic at Children's Hospital of Wisconsin will screen for common     conditions associated with atopic dermatitis and subsequently treat or refer patients for     appropriate care. The investigators hypothesize that Milwaukee County pediatric patients with     atopic dermatitis will have a high prevalence of asthma needing treatment, missed     immunizations requiring catch-up, and vitamin D deficiency necessitating replacement therapy.   "
156530|NCT01234896|"     Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study     in healthy smokers.   "
156531|NCT01234883|"     The primary objective of this study is to compare the efficacy and safety of the use of a     multiple electrolyte solution to the use of saline for the treatment of moderate to severe     dehydration due to acute gastroenteritis (AGE) in children.   "
156535|NCT01234831|"     Methicillin-resistant Staphylococcus aureus (MRSA) is endemic in hospital settings.     Colonization with MRSA puts patients at increased risk for invasive infections, and MRSA     infections have been associated with high costs and adverse clinic outcomes. Patients can     clear MRSA spontaneously. Improved approaches for identifying patients who are no longer     colonized are needed; we hypothesize that more sensitive nucleic acid amplification can be     used to improve identification of patients who are no longer colonized.   "
156536|NCT01234818|"     A prospective multicenter trial has been started in Korea to investigate the treatment     efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) in endometrial hyperplasia     (EH) patients. The LNG-IUS is known as an alternative of oral progesterone agents without     incurring the disadvantages of oral progestogens. Therefore, it is hypothesized that if the     therapeutic efficacy of LNG-IUS is similar or above oral progesterone, LNG-IUS would be a     standard treatment for the EH patients who don't want hysterectomy. LNG-IUS is inserted into     uterus of which patients are histologically confirmed as endometrial hyperplasia. Office     endometrial aspiration biopsy and transvaginal ultrasound is conducted every 3 months at     outpatients The primary endpoint is response rate. Secondary endpoint is to estimate the     consistency of the results between office endometrial aspiration biopsy and dilatation and     curettage (D&C) procedure.   "
156537|NCT01234805|"     This clinical trial studies yoga therapy in treating patients with malignant brain tumors.     Yoga therapy may improve the quality of life of patients with brain tumors   "
156538|NCT01234792|"     Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.   "
156539|NCT01234779|"     This randomized, double-blind, placebo- and active-controlled, parallel group study will     evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute     exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg     or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients,     with a 4-week follow-up period.   "
156540|NCT01234766|"     The purpose of the study is to learn about the safety and effectiveness of treating     follicular lymphoma with bendamustine and rituximab followed by radioimmunotherapy (RIT)     using 90-yttrium (Y) ibritumomab tiuxetan.      The researchers will also test blood and bone marrow for the BCL2 gene-Jh that is a commonly     found in people with follicular lymphoma (FL) and look at how the BCL2 gene-Jh responds to     the study treatment.      Bendamustine is approved by the United States Food and Drug Administration (FDA) for the     treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma (NHL)     that has progressed during or within six months of treatment with rituximab or a     rituximab-containing treatment regimen. Bendamustine is not approved by the FDA to treat     follicular lymphoma.      Rituximab is approved by the FDA for the treatment of relapsed or refractory, low-grade or     follicular, CD20-positive B-cell non-Hodgkin's lymphoma.      90-yttrium (Y) ibritumomab tiuxetan is approved by the FDA for the treatment of relapsed or     refractory, low-grade or follicular B-cell NHL, including rituximab refractory follicular     NHL. It is also approved for the treatment of follicular NHL that is previously untreated     with radioimmunotherapy and that achieved a partial or complete response to first-line     chemotherapy.      Study participants will will receive bendamustine and rituximab for up to 16 weeks. If     participants' cancer responds well to the treatment with bendamustine and rituximab, they     will receive up to 12 weeks of radioimmunotherapy (RIT). After the RIT is complete,     participants will be asked to return to the clinic every 3 months for a maximum of 10 years     for follow-up visits.   "
156541|NCT01234753|"     The number of adults with congenitally malformed hearts is increasing. According to a     prospective population-based cohort study from Sweden (1992-2001) the prevalence of     cardiovascular defects was 9.1 per 1,000 births, which is comparable to other presented     prevalence data in the world.On the basis of 9 million inhabitants, Sweden should have     approximately 82000 born with CHD and approximately 20000 will, in adult age, need regular     follow up in cardiac care. This is a result of the greater improvements within paediatric     heart surgery and there is an increasing demand for continuous follow up in the healthcare     system.[2] Guidelines from the European Society of Cardiology and the Canadian Cardiovascular     Society recommend follow-up oriented towards both medical and psychosocial problems.      Earlier studies have shown that adults with CHD have poor knowledge about their heart     disease.The results are difficult to summarise because of the use of different instruments,     methods and sample sizes. Most of the adults with CHD did not know their clinical diagnosis     or what endocarditis was. However, we do not know if everyone in these studies was     recommended endocarditis prophylactics or their definition of poor knowledge.      At present different programmes for adults with CHD are established in hospital outpatient     clinics. These studies describe the established programmes. They also address the needs for     development of care e.g. a multicenter approach, transitions from paediatric to adult health     care, delivery care in Europe, programmes for pregnancy, how to provide clinical strategies,     health care resource utilization or outpatient nursing clinic for adults with CHD. But there     is a lack of knowledge regarding how education and psychosocial support should be given to     adults with congenitally malformed hearts and what effects that can be achieved. The aim is     to evaluate the effects of a nurse-led intervention consisting of education by a     computer-based educational programme and psychosocial support to adults with congenitally     malformed hearts.   "
156542|NCT01234740|"     RATIONALE: Bafetinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This clinical trial studies bafetinib in treating patients with recurrent high-grade     glioma or brain metastases.   "
156543|NCT01234727|"     A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system     commercially available in Germany & Holland.   "
156544|NCT01234714|"     The purpose of this study is to objectively quantify liver fat content (LFC) by Magnetic     Resonant Imaging (MRI) prior to major liver surgery, and to investigate its association with     post-operative complications.   "
156545|NCT01234701|"     The purpose of this multicenter study is to evaluate the agreement among expert radiologists     in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in     non-cirrhotic patients.   "
156546|NCT01234688|"     The investigators raised the hypothesis that exercise training would be associated with     improvement in exercise tolerance and VO2 kinetics in hemodialysis patients.   "
156547|NCT01234675|"     Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most     of the patients with fibromyalgia complain of either non-restorative sleep or complaints of     disturbed sleep due to pain. The proposed study is aimed at examining the effects of     milnacipran on sleep disturbance in patients with fibromyalgia. The study is randomized,     double-blind, placebo controlled, two way crossover PSG study to explore the effects of     milnacipran on sleep disturbance. Patients will receive either milnacipran 50 mg BID or     matching placebo.   "
172780|NCT00094939|"     The goal of this project is to develop an early diagnostic test for Alzheimer's disease (AD)     by monitoring loss of neurons and brain size reductions over a period of five years.   "
156549|NCT01234649|"     A diagnosis of gestational diabetes mellitus (GDM)has significant implications for the future     health of the mother. GDM is often the culmination of years of unrecognized and unmodified     diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy.     Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will     develop type 2 diabetes (DM2) at rates much greater than control groups who did not have     glucose intolerance during pregnancy. Liraglutide may potentially delay disease progression     in GDM considering the beta -(ß-)cell function improvement in DM2 and ß-cell mass shown to     increase in animal models. This study will examine if the addition of liraglutide to     metformin therapy is more effective than metformin alone in improving insulin sensitivity and     normalizing insulin secretion in at-risk overweight/obese women with prior GDM.   "
156550|NCT01234636|"     Cardiovascular disease is a major cause of mortality worldwide resulting in one out of three     global deaths. One of the main characteristics of cardiovascular disease is impaired blood     flow and increased formation of clots. Platelets are clot-forming cells responsible for     prevention of bleeding. However, in disease state they may be overly activated and tend to     stick to each other, promoting blood clots and blockage of vessels.      Conjugated linoleic acids (CLA) are unique fatty acids present in dairy food products and     beef which would help to prevent platelets from clotting and thus help to prevent     cardiovascular disease. However, the mechanisms by which those fatty acids affect platelet     function are not yet fully understood. We designed a human intervention study assessing the     mechanisms by which CLA beneficially affect platelet function and markers of haemostasis and     inflammation in humans.   "
156551|NCT01234623|"     Human autologous serum (AS) eye drops have been successfully used in the treatment of severe     ocular surface disorders and the enhancement of corneal wound healing, due to their growth     factor (GF) content. Umbilical cord serum (UCS) contains even higher GF concentrations and     the objective of the study was to prove whether UCS eye drops        1. are effective in the healing of corneal epithelial defects.        2. ameliorate the painful subjective symptoms   "
156552|NCT01234610|"     An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta,     which is a large blood vessel in the abdomen. Large AAAs (>55 mm diameter) carry a high risk     of rupture, a surgical emergency that often leads to death due to severe internal bleeding.     It has been suggested that regular exercise training might limit the rate at which AAAs     develop. However, little is known about the safety and effectiveness of exercise training in     these patients. This pilot study will examine the feasibility of supervised aerobic exercise     training for patients with small AAAs (30 to 49 mm diameter). The investigators hypothesize     that exercise training will be safe and useful for patients with small AAAs.   "
156553|NCT01234597|"     Primary Objective:      To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose     monitoring, on glucose control in type 2 diabetes patients who are not controlled by     treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus     regimen   "
156554|NCT01234584|"     The purpose of this present study is to compare alveolar bone changes and markers of gingival     health around the new Lanes® dental implant which were rehabilitate using the new switch     platform abutment ( SPR ) and the traditional ( CPK ) abutment.   "
156555|NCT01234571|"     Remodulin (Treprostenil sodium) is synthetic prostacyclin analog available as a solution for     administration in the intravenous route. It is approved for treatment of class I - pulmonary     hypertension functional capacity stage III-IV. A key factor for the success of pulmonary     hypertension therapy is maintaining near constant blood level of a given medications along     the day. A sudden decrease in the blood levels might lead to rebound phenomenon; abrupt     increase in the pulmonary artery pressure which might lead to acute right ventricular failure     and even to sudden death. As some PHT patients suffer are on hemo-dialysis therapy due to     end-stage renal disease there is a need to document the variation of the blood level along     the dialysis cycle.   "
156556|NCT01234558|"     The purpose of this study is to determine whether GLYX-13 reduces depression score in     patients with treatment-resistant depression.   "
156557|NCT01234545|"     This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy     of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant     human factor VII) in patients with haemophilia A and B patients with inhibitors.   "
156558|NCT01234532|"     This phase II trial is studying how well giving entinostat and anastrozole together works in     treating postmenopausal women with triple-negative breast cancer that can be removed by     surgery. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using     anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells.     Giving entinostat together with anastrozole may be an effective treatment for breast cancer.   "
156559|NCT01234519|"     The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients     with a tumor of the urinary system.   "
156560|NCT01234506|"     A major means whereby oxidative stress promotes aging-related disease is by activating     inflammatory pathways. Decreasing oxidative stress and inflammation should ameliorate many of     the problems associated with aging, including vascular dementia, Alzheimer's disease,     osteoporosis, muscle wasting, insulin resistance, type 2 diabetes, and metabolic syndrome.     Animal and human studies have demonstrated that consumption of vitamin D and phase 2 protein     inducers decrease oxidative stress and associated inflammation. The flax lignan     secoisolariciresinol diglucoside (SDG) is metabolized to enterolactone, a potent phase 2     protein inducer. Animal and human studies have shown that consumption of flax seed or its     component SDG decreases hypertension, serum cholesterol, atherosclerosis, the growth of     experimentally-induced cancers as well as metastases of human breast tumours implanted into     nude mice, and delays the development of type 2 diabetes. Vitamin D plays a role in     modulating inflammation, enhancing immunity (while suppressing autoimmune injury) and     exerting control over cell differentiation. Adequate levels of vitamin D also appear to     promote better glycemic control. The investigators predict that consumption of SDG in persons     with adequate vitamin D status will decrease oxidative stress and associated inflammation. If     this hypothesis is upheld, this research has the potential to greatly decrease healthcare     costs while allowing healthier aging.   "
180839|NCT00212550|"     Obtain sputum smears within one day to rule out TB   "
156562|NCT01232673|"     A total of 90 patients suffering from end stage-IV Fontaine /CLI and diabetic foot with an     ulcerated limb in whom all previous therapeutic strategies failed (e.g. surgical     revascularization) will be selected and undergo local transplantation of ABMSCs. The     efficacy/safety of this therapy will be assessed by using several endpoints such as (a)     prevention of amputation, (b) wound healing and (c) degree of angiogenesis. In order to     assess the limb ischemia and hypoxia the several tests and measurements will be performed     pre- and post transplantation at a variety of time intervals. The measurements include:     TP-toe pressure measurements (by Periflux 5000 Laser Doppler and Oxymetry system), SPP-skin     perfusion pressure, ABI-ankle brachial index, LDP-laser Doppler baseline and heat perfusion     assessment, TcpO2 without and with O2 provocation inhalation test. In addition, a battery of     biochemical and hematological tests of peripheral venous blood sample will be performed.The     quality form EQ-50 will be completed.      8.1 Primary objective: To evaluate an efficacy-safety profile of autologous bone marrow stem     cells (ABMSCs) transplantated into chronically and critically ischemic limb (CLI) and into     diabetic foot in stage IV Fontaine, Rutherfod 4-6 classification.      8.2 Secondary objectives: 8.2.1 To assess effect of ABMSCs on tissue perfusion of ischemic     limb after transplantation by transcutaneous oximetry and the laser Doppler flowmetry using     Periflux 5000 system under normal and provocation test conditions. In addition, wound healing     of ulcers will be evaluated using a planimetry method from photographs of affected skin taken     pre- and post-transplantation.      8.2.2 Relationship between CD 34 progenitor counts separated on gradient-density separation     centrifuge from Harvest Technologies and overall effectiveness and safety to treat ischemic     limb.      8.3 Priorities: Beside assessment of effectiveness and safety of ABMSCs transplantation     ultimate emphasis will be put on avoiding limb amputation. This has significant socioeconomic     impact. Therefore this project belongs to the priority programs of clinical research in     cardiovascular diseases.   "
156563|NCT01232660|"     The purpose of the study is to examine the effects of adding a drug called     hydroxychloroquine, usually used to treat rheumatoid arthritis, to patients' usual     antiretroviral combination. HIV causes activation of some parts of the immune system and this     immune activation may persist despite effective antiretroviral therapy. Ongoing activation     may be responsible for poor CD4 rise on antiretroviral therapy and for some HIV-related     complications. Drugs like hydroxychloroquine work by inhibiting immune activation.      The study will primarily investigate the effect of adding this medication on immunological     parameters (particularly CD4 count), on other safety parameters (such as cholesterol),     patients' side effects and viral load.      If you decide to take part, the duration of your involvement in the study will be 24 weeks     plus two screening visits up to 84 days prior to the start of the study and a follow up     visit.   "
156564|NCT01232647|"     Vitamin K is thought to be important for bone health because it activates several proteins     involved in bone formation. Poor dietary intake of vitamin K (mainly found in dark green     leafy vegetables) is associated with bone loss and fractures. Giving supplements of the main     dietary form of vitamin K (called K1) or another common form which our bodies make from     K1(called MK4), to improve bone health have given mixed results. This confusion is thought to     have arisen because these studies involved people who already had enough vitamin K or did not     have osteoporosis. We want to test the hypothesis that treatment with bisphosphonates     combined with vitamin K, in vitamin K deplete elderly women with osteoporosis, may offer     additional benefit on skeletal metabolism and reduction of fracture risk. We want to test     this by measuring vitamin K status in post-menopausal women with osteoporosis who are on the     recommended treatment with a bisphosphonate and calcium/vitamin D supplements. Those with low     vitamin K will then be recruited to study the effect of supplementation with either K1 or     MK4.   "
156565|NCT01234467|"     The purpose of this research study is to learn about the safety of the treatment with a     combination of bendamustine and rituximab and to find out what effects, both good and bad     this treatment has on DLBCL. In addition to learning about the combination of bendamustine     and rituximab, the researchers are interested in learning about how this cancer treatment     affects daily activities. Subjects will be asked to complete a Geriatric Assessment (GA). GAs     are designed to gather information on memory, nutritional status, mental health, and level of     social support. GAs are also designed to help the health care team understand how well     subjects can carry out their day to day activities and to briefly describe what other medical     conditions subjects may have. This assessment will help the health care team understand a     subject's functional age (the age a subject functions at) as compared to a subject's actual     age.      The researchers also want to learn how chemotherapy affects the aging process in our bodies.     This is done by measuring the amount of p16 in blood. Researchers want to understand if     chemotherapy changes the levels of p16 in blood.   "
156566|NCT01234454|"     The general aim is to compare the effects of typical and atypical antipsychotic medication on     brain structure and function. A parallel group treatment trial will be utilized to compare     the effects of the typical antipsychotic thiothixene versus the atypical antipsychotics     risperidone (RIS) and olanzapine (OLZ) on brain structure and function in schizophrenia in an     effort to determine the neuroanatomic basis for cognitive pathology in schizophrenia and its     amelioration by atypical antipsychotic drugs.   "
156567|NCT01234441|"     Chronic kidney disease (CKD) patients receiving hemodialysis treatment (CKD stage 5) suffer     from a variety of co-morbid diseases, many of which may be mechanistically linked. Protein     malnutrition, muscle catabolism and wasting are especially common, and these lead to reduced     muscle strength, declines in physical function, and low levels of physical activity. Physical     inactivity exacerbates these functional declines, and also promotes cardiovascular disease     (CVD) and bone disorders. This cycle of disease and disability greatly reduces quality of     life (QOL) and increases mortality rates in dialysis patients.      Many factors contribute to the development of these co-morbidities. Chronic inflammation is     believed to be a cause and a consequence of the protein malnutrition, CVD and bone disorders     in dialysis patients. In addition, abnormalities in mineral metabolism resulting from the     deficit in kidney function promote the loss of mineral from bone and the deposition of     mineral in the vasculature, a process termed vascular calcification (VC). VC is associated     with a variety of CVD-related disorders, including arterial stiffness, increases in arterial     wall intima-media thickness (IMT), left ventricular hypertrophy (LVH), and declines in     cardiac function. As a result of these abnormalities, cardiovascular events are 10 to 30     times greater in dialysis patients than in age- and sex-matched subjects in the general     population.   "
156568|NCT01234428|"     The purpose of this study is to determine whether esophageal dysmotility and dilatation is an     important complication in the long term follow-up following laparoscopic gastric banding for     morbid obesity.   "
156569|NCT01234415|"     The aim of this project is to evaluate the safety and efficacy of the biomaterial made of     HAP/TCP (BCP, Kasios®), in septoplasties of multi traumatized human nose. The use of this     biomaterial will avoid the graft sampling and we expect it to be a good substitute to support     the nasal pyramid while favouring the respiratory epithelium regeneration. Thus, that would     confirm previous in vitro and in vivo studies.   "
156570|NCT01234402|"     An open-label, multicenter, randomized, Phase 2 trial in which patients with unresectable,     locally advanced or metastatic breast cancer who have been previously treated with     anthracycline and taxane therapy receive ramucirumab DP or IMC-18F1 administered on an     every-21-day cycle (in combination with oral capecitabine therapy; capecitabine is     administered twice a day on Days 1-14 of each cycle). Approximately 150 patients will be     randomized in a 1:1:1 ratio to either ramucirumab DP or IMC-18F1 in combination with     capecitabine (Arm A and Arm B, respectively) or capecitabine monotherapy (Arm C).     Randomization will be stratified by triple-negative receptor status (estrogen     receptor-negative, progesterone receptor-negative, and human epidermal growth factor     receptor-2 [HER2/neu]-negative) (yes/no) and receipt of prior antiangiogenic therapy.      Treatment with the study medication(s) will continue until disease progression, the     development of unacceptable toxicity, noncompliance or withdrawal of consent by the patient,     or investigator decision. Capecitabine dose reductions in the setting of significant     myelosuppression, hand-and-foot syndrome, or diarrhea will be required.   "
156571|NCT01234389|"     Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general     population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma and     gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool antigen     tests, histology or the Helicobacter urease test (HUT).      The aim of our study is to access the clinical reliability of a new, electrochemical device     for rapid H. pylori detection.   "
156572|NCT01234376|"     Confocal laser endomicroscopy enables in vivo microscopic imaging within the mucosa layer of     the gut at a subcellular resolution. Various studies have addressed the potential of     endomicroscopy for the in vivo diagnosis of esophageal squamous cell carcinoma, Barrett´s     esophagus and esophageal adenocarcinoma. Currently, there is only one case report from our     group who noted the utility of endomicroscopy for the in vivo diagnosis of eosinophilic     esophagitis.      The purpose of this study is to determine whether endomicroscopy is effective for the in vivo     diagnosis of eosinophilic esophagitis.   "
156573|NCT01234363|"     The purpose of this study is to assess the potential of elastography for noninvasive     assessment of fibrosis in renal allograft.   "
156574|NCT01234350|"     This study is a large observational study set-up to observe how the long-term treatment of     Firmagon (hormone regulator) compared to another treatment will effect specific conditions     such as cardiovascular events, changes in bone density, changes in blood sugar levels or     liver enzyme levels in patients with prostate cancer. Patients will be treated according to     their routine clinical care and this will not be dictated by the study. As the study is     observational in nature, the study will collect specific data relating to the 3 specific     events above. Patients that agree to this study will be followed-up for 5 years. Patient data     will be collected every 3 months for the first 2 years and every 6 months for the last 3 yrs.   "
156575|NCT01234337|"     The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in     combination with capecitabine versus capecitabine in combination with placebo in the     treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are     resistant to or have failed prior taxane and an anthracycline or for whom further     anthracycline therapy is not indicated. After signing consent there can be up to 28 days     before starting the treatment during which time a number of tests will be carried out which     will include tumor evaluations and medical history. The following tests and evaluations will     have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the     end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a     complete physical exam and vital signs. Treatment will be given in 21 day cycles with     sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the     first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every     cycle after the first 2 cycles. During the weekly visits the subjects will be check for any     side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will     be followed for overall survival.   "
156576|NCT01234324|"     That panitumumab in combination with Epirubicin, Cisplatin and Capecitabine (ECX) will safely     decrease the frequency of pT3/T4 below that of ECX alone in subjects with locally advanced     adenocarcinoma of the stomach and gastroesophageal junction.   "
156577|NCT01234311|"     This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in     asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of     tasquinimod on delaying disease progression compared with placebo.      Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1     ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day;     n=800) or Treatment Group B (placebo; n=400).   "
156578|NCT01234298|"     To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to     placebo when given as adjunctive therapy to antipsychotic medication in clinically stable     adults with persistent predominant negative symptoms of schizophrenia.   "
156579|NCT01234285|"     Sepsis is a syndrome comprised of a systemic inflammatory response, signs of tissue     hypoperfusion, and organ in the setting of presumed infection. Heparin, in addition to being     an anticoagulant, is also a well-known antiinflammatory. The investigators believe that     unfractionated heparin has the potential to save the lives of septic patients at a     drastically reduced cost. This is a dose escalation study to determine the safety of     increasing levels of heparin in this patient population; compare markers of anticoagulation     and inflammation between treatment groups; and compare clinical outcomes between groups.   "
156580|NCT01234272|"     The present study was designed to assess analgesic capacity of intrathecal administration of     morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared     to patient controlled epidural analgesia using fentanyl and repivacaine (PCEA) in patients     undergoing gastrectomy. The investigators hypothesized that ITM-PCA would show comparable     analgesic effect to PCEA in gastrectomy.   "
156667|NCT01233362|"     The absence of a boosting response after a 14 day interval with the two-dose regimen of the     modified killed oral cholera vaccine raises the possibility that a longer dosing interval may     be required to observe a boost in the immune response. This study will compare the immune     responses following 14-day and 28-day dosing intervals.   "
164869|NCT00005445|"     To study three possible, but yet unproven, influences on pediatric asthma hospitalization     rates - diagnostic substitution, different systems of medical care, and asthma medication     use.   "
156581|NCT01234259|"     Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis     and hypodermis.      Radio-frequency (RF) devices have been used for many years for a variety of surgical     applications. The energy delivery systems of these established monopolar devices used a     'conductive coupling' delivery system in which energy is concentrated at the periphery of the     electrode.      Venus Concept has developed the Venus Freeze (MP)2 V2 system for wrinkles, rhytides and     temporary cellulite and circumference reduction treatments. While treating wrinkles rhytides     and cellulite, the treatments creates enough thermal effect to induce collagen remodeling     with no ablative thermal damage in the epidermis or dermis.   "
156582|NCT01234246|"     In this project the main focus is on assessing sexual functioning and the quality of sexual     life after the treatment of colorectal cancer in patients and their partners.      Patients and their partners complete questionnaires concerning sexual functioning, quality of     life, body image, fatigue, anxiety, depressive symptoms, personality factors, and demographic     factors. Questionnaires are completed before surgical treatment, 6 weeks, 3 months, 6 months,     and 12 months after diagnosis.      The results of this prospective study will give insight in 1) the incidence of sexual     problems and the extent patients with colorectal cancer and their partners are bothered by     these problems across time, 2) the effect of different treatment modalities on sexual     functioning, 3) the relation between sexual problems and quality of life, 4) the determinants     of sexual problems and the quality of sexual life adopting the biopsychosocial approach of     patients with colorectal cancer who have been treated with surgery, radiation and/or     chemotherapy, and more specifically to the role of personality and patient factors and sexual     functioning/the quality of sexual life.   "
156583|NCT01234233|"     The investigators want to evaluate the effect of prewarming on the rate of postoperative     hypothermia and shivering and to compare sublingual versus tympanic temperature assessment     during the perioperative period in patients.      Patients will be randomly assigned to 4 groups with different duration of prewarming. Body     temperature will be recorded regularly by sublingual and tympanic (by thermocouple)     measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed     postoperatively.   "
156584|NCT01234220|"     The AVIS Study is a retrospective multicenter international study that aims to answer a     series of questions on the use and performance of adrenal venous catheterization (AVS) for     the diagnosis of primary hyperaldosteronism subtype. A questionnaire will be circulated among     the centres that are internationally recognized and have published in the field of AVS and     have agreed to participate in the study.      The first aim of the AVIS study is to collect summary data on how AVS is being performed     throughout the world to answer the following questions:        -  How many AVS studies haw been performed yearly from 2005 to 2010 at each center?        -  How many adrenal vein ruptures occurred during the AVS at each center?Has the rate of          adrenal vein rupture been steady or has it changed over the 5 years?        -  How many centers use bilaterally simultaneous and how many use sequential AVS          catheterization?        -  How many radiologists perform AVS at each center?        -  How many centers use a cosyntropin stimulation during AVS?        -  What is the percentage of PA patients in whom AVS is performed?        -  How many centres calculate the selectivity index? What is the minimum cutoff used?        -  How many centers calculate the lateralization index? What is the minimum cutoff used?        -  Are the AVS studies that are not bilaterally selective used for diagnosis?        -  How many centers calculate the controlateral suppression index and what is the minimum          cutoff used?        -  What is the cost of AVS for the National Health System or Insurance and for patients?          The second aim of the study is to calculate the rate of AVS studies that are selective          and show lateralization of aldosterone excess at each center by applying predefined set          of criteria for defining selectivity and lateralization. Data on the final diagnosis of          the PA subtype will be gathered and used as reference to assess the performance of AVS          using receiver operating characteristic curves analysis and the Youden index to          determine the optimal cutoffs. A worksheet will need to be completed providing          information on the following: Demography; Date of AVS;Baseline blood pressure (BP)          values and serum K+;Dynamic test during the AVS if any; plasma aldosterone and cortisol          concentration in the infra-adrenal inferior vena cava and in the right and left adrenal          vein; diagnosis of PA subtype; treatment (adrenalectomy or pharmacological therapy);          post-treatment BP and serum K+ values; concordance/discordance between imaging (CT or          RM) and AVS.   "
156585|NCT01234207|"     The purpose of this study was to compare objective clinical measures of visual performance     and subjective measures of satisfaction and preference between standard progressive addition     lens (PAL) spectacles and a new type of free-form surfaced, optically customized PAL     spectacle.   "
156586|NCT01234194|"     The purpose of the study is to determine if the new Composite Variability Index (CVI) is     capable of detecting changing effect compartment concentrations of remifentanil. In addition,     it is planed to detect if the change in CVI in response to a standardized painful stimulus is     dose-dependent.   "
156587|NCT01234181|"     The purpose of this study, is to determine the differences of clinical outcomes between     hypoxic pre-treatment group and control group in bone marrow stem cell transplantation     (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both     treatments. Heart failure patients underwent PCI treatment after AMI and with informed     consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic     pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into     patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected;     echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive     myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We     hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be     reversed in heart failure patients.   "
156588|NCT01234168|"     The purpose of the protocol is to to assess subject's overall satisfaction regarding control     of diarrhea. The study aims to supplement results obtained through clinical trials with data     obtained from a population of patients receiving treatment with Somatuline Autogel in routine     practice.   "
156589|NCT01234155|"     The purpose of this study is to assess whether 4-months of interval-walking exercise training     improves glycemic control in individuals with type 2 diabetes mellitus. The effects of     interval-walking training will be compared to continuous-walking exercise in a randomised,     controlled trial design. Changes in glycemic control will be examined using oral glucose     tolerance tests (OGTT) with stable isotope methodology. In addition, insulin sensitivity and     secretion will be examined using glucose clamps combined with glucagon-like peptide 1 (GLP-1)     and glucose-dependent insulinotropic polypeptide (GIP).   "
156590|NCT01234142|"     This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a     varenicline patch applied once daily to the skin for 14 days.   "
156591|NCT01234129|"     Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.   "
156592|NCT01234116|"     Objective: The objective of this study is to determine the safety and tolerability of     Post-exposure Prophylaxis (PEP) with a regimen of Truvada + Kaletra among health care workers     (HCWs) at Henry Ford Hospital.      Hypothesis: Raltegravir is safe and better tolerated compared with Kaletra, each in     combination with Truvada, as assessed by review of completion rates of PEP and also review of     completed safety data.   "
156593|NCT01234103|"     Health damaging (risk) behaviors of young military personnel are reflections of health     problems facing all young people in the U.S. Military life presents opportunities and     challenges that may both protect against and place young troops at risk for health damaging     behaviors. Challenges for maintaining a healthy armed force include high rates of sexually     transmitted infections (STIs), unintended pregnancies (UIPs), misuse of alcohol and other     substances. The common thread through these negative health outcomes is volitional behavior.     Such behaviors do not only result in illness or injury, but also negatively impact     performance of military duties and threaten military readiness. Despite military leadership     in setting standards and policies regarding professional behavior and universal health care     for preventing and eliminating such negative health outcomes, many health problems remain.     Building on our previous military research, we will evaluate the effectiveness a     cognitive-behavioral, skills-building intervention to prevent and reduce young troops' risk     for and acquisition of STIs and UIPs and will seek to reduce a number of their associated     risk factors including, alcohol misuse, other substance use, and victimization due to IPV in     male and female U.S. Army soldiers who are receiving Advance Individual Training (AIT) in     Fort Jackson, SC.   "
156594|NCT01234090|"     This prospective cohort study hypothesizes that an analysis of parallel qualitative and     quantitative data is necessary to examine the full experience of living with aphasia. It is     also hypothesized that there are specific factors that act as barriers or facilitators to     successfully living with aphasia. A unique aspect of the project is the use of the Assessment     for Living with Aphasia (ALA), a new aphasia friendly measure based on the World Health     Organization International Classification of Functioning, Disability and Health (WHO ICF).     Each session will assess written and spoken language, functional communication, mobility,     Activities of Daily Living (ADL) function, burden of stroke, quality of life, and depression.   "
156595|NCT01234077|"     Research study that will test a portable device (CPC M1) that records: body movement; heart     activity (ECG; snoring; and body position during sleep. The Food and Drug Administration     (FDA) has not approved this device for use except in a research setting.      The purposes of this study are to: a) determine if the ECG data collected using the CPC M1     device is at least as good as the ECG data collected during a diagnostic, in-lab     polysomnogram (PSG) (or sleep study) and b) determine if in-home monitoring with the device     will provide similar results compared to an in-lab PSG.   "
156596|NCT01234064|"     This is a pilot substudy to the PeriOperative ISchemic Evaluation-2 Trial (POISE-2), to     assess the feasibility of adding graduated compression stockings (GCS) to POISE-2 as an     intervention.   "
156597|NCT01234051|"     1. Goals             -  The primary goal of this phase II trial is to:           evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in          patients with locally advanced or metastatic BTC as first-line therapy           Secondary goals are to:evaluate the treatment-related toxicities of this combination,          investigate progression-free survival (PFS) and overall survival (OS) in this population        2. Design      The proposed clinical trial is an open label, non-comparative, multicenter phase II trial     according to the two stage testing design by Simon.22   "
156598|NCT01234038|"     The purpose of this study is to examine the overall survival of patients with Stage IV     non-small cell lung cancer (NSCLC) treated with ISIS EIF4E Rx in combination with carboplatin     and paclitaxel.   "
156599|NCT01234025|"     The purpose of this study is to examine the safety, tolerability and progression-free     survival of patients with Castrate-Resistant Prostate Cancer treated with ISIS EIF4E Rx in     combination with docetaxel and prednisone.   "
156600|NCT01234012|"     The purpose of this study is assess the safety of administering repeated doses of IMF-001, a     vaccine, to patients with solid tumors that express NY-ESO-1 antigen. If the vaccine is     therapeutically useful, a second goal is to establish the maximum therapeutic dose to treat     patients with NY-ESO-1 positive cancers.   "
156601|NCT01233999|"     The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is     a painful condition in which cold surroundings or stressful events trigger pain, a cold     sensation, and in severe cases, sores and ulcers on one's fingers. The investigators think     that RP results from problems with some of the components of the blood vessels, surrounding     nerves, and some of the circulating messengers in the bloodstream. Although there are many     different medicines that are currently used to treat RP, the investigators have not yet found     a cure for severe cases of this condition. Furthermore, the investigators have found few     medicines that show consistent healing of the ulcers that may be associated with RP. Some of     the treatments include medicines that are used to treat high blood pressure known as calcium     channel blockers. Medications that thin the blood (anticoagulants) such as aspirin have also     been used to treat RP.      In this study, the investigators will investigate a new treatment for RP known as Botulinum     toxin A. Botulinum toxin is a chemical that is temporarily toxic to nerves, but has been     approved by the government for the treatment of several other conditions including but not     limited to: excessive sweating, neck pain associated with a condition known as cervical     dystonia, uncontrollable forcible closure of the eyelids known as blepharospasm, and a     condition known as strabismus in which the eyes are not in alignment with one another.      This study will aim to greatly improve the quality of life and pain associated with RP.     Previous studies also support the chance that Botulinum toxin will help to heal some of the     ulcers associated with RP. Although there is no current standard of care, many of the     patients in the study will have already failed or are unable to tolerate commonly used     treatments such as lifestyle modifications, calcium channel blockers, nitroglycerin, and     anticoagulants. If the patient chooses to participate in the study, he/she will be randomly     assigned to receive an injection with Botulinum toxin in either the left or right hand. The     other hand will be injected with saline solution. Neither the patient nor the physician or     research personnel seen in follow-up will know which hand is injected with Botulinum toxin.   "
156602|NCT01233986|"     The purpose of this study is to evaluate whether the serum apoB48 level is associated with     atherosclerotic ischemic stroke.   "
156603|NCT01233973|"     To compare the decision making of elderly subjects having a verbal advance care planning     discussion compared to subjects using a video.   "
156604|NCT01233960|"     To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol     603 to evaluate the safety in subjects with active Crohn's disease who are resistant to     standard Crohn's disease therapies.   "
156605|NCT01233947|"     AFP464 is an investigational agent which may be effective in the treatment of cancer. The     purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer     patients.   "
156642|NCT01232426|"     Intra-articular fractures at the dorsal base of the distal phalanx of the hand are usually     referred to as Mallet fractures. Treatment of Mallet fractures remains controversial.     Although no differences in clinical results are reported between conservative treatment and     operative treatment, operative treatment is suggested for fractures involving more than 30%     of articular surface. There are many different operative techniques, all with specific     disadvantages. The investigators hypothesis is that operative treatment of Mallet fractures     with one Meniscus Arrow® has a better outcome than conservative treatment with a Mallet     splint.   "
156606|NCT01233934|"     Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by     mast cells in the skin. Topical anti-histaminics can be used to promote relief of these     symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation     approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the     ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority     of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the     standard preparation (1% cream) for the relief of insect bite related symptoms and to     demonstrate the safety of both preparations.   "
156607|NCT01233921|"     RATIONALE: Growth factors, such as palifermin, may prevent chronic graft-versus-host disease     caused by donor stem cell transplant.      PURPOSE: This randomized clinical trial studies palifermin in preventing chronic     graft-versus-host disease in patients who have undergone donor stem cell transplant for     hematologic cancer   "
156608|NCT01233908|"     To investigate the prevalence of posttraumatic stress disorder (PTSD) in patients that     underwent surgery for primary rhegmatogenous retinal detachment (RRD) and to determine     variables associated with the disorder.      Design: Consecutive prospective observational study.   "
156609|NCT01233895|"     Primary Objectives:      Study Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on     pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth factor     1 [IGF-1] serum level) parameters, and eventual dose limiting toxicities (DLTs) in patients     with recurrent, refractory multiple myeloma (MM).      Study Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the     recommended dose of Velcade®.      Secondary Objectives :      Study Part 1:        -  To assess the safety profile: type, incidence and intensity of drug related adverse          events (AEs)        -  To assess the biological activity of AVE1642 (saturation of the receptors and          down-regulation) on malignant plasma cells and on peripheral blood mononuclear cells          (PBMC) and granulocytes        -  To assess the biological activity of AVE1642 on the signalization pathway of the IGF-1          system (phosphorylated akt [pAkt], phosphorylated erk [pErk]) on malignant plasma cells          when technically possible        -  To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3        -  To assess clinical efficacy (complete response [CR], partial response [PR], minimal          response [MR] and stabilization) based on the European group for Blood and Marrow          Transplantation (EBMT) criteria, when possible        -  To assess potential immunogenicity by detection of human antihumanized antibodies (HAHA)          anti-AVE1642      Study Part 2:        -  To detect any PK or PD interaction between AVE1642 and Velcade®        -  To assess clinical efficacy (CR, PR, MR, no change [NC]) according to EBMT criteria when          appropriate        -  To assess biological activity of AVE1642 in combination with Velcade® on malignant          plasma cells collected from bone marrow aspirates: saturation and down-regulation of the          insulin-like growth factor 1 receptor (IGF-1R) and activity on the signalization pathway          of the IGF-1 system (pAkt, pErk) when feasible        -  To detect immunogenicity reaction (HAHA)        -  To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be          non biologically active   "
156610|NCT01233882|"     This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with     renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe renal     impairment and subjects with normal renal function will be enrolled. Subjects with mild and     moderate renal impairment will be enrolled in Stage 2 if the results from Stage 1 suggest a     substantial difference in PK profiles between subjects with severe renal impairment and     subjects with normal renal function.   "
156611|NCT01233869|"     This purpose of this study is to determine if bosutinib reduces the rate of kidney     enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering     the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or     equal to 60 mL/min/1.73m2.   "
156612|NCT01233856|"     Type of study:      This study is a prospective, randomized, placebo controlled, double blind trial comparing the     response to treatment in children with a diagnosis of ADHD treated with stimulants and     placebo vs. children with a diagnosis of ADHD on stimulants plus Omega-3 fatty acids.      Hypothesis:      The use of Lovaza (prescription Omega-3 fatty acids) as an adjunctive therapy for children     with adequate diagnosis of ADHD on treatment with stimulants will not improve their     functioning and behavior measured by the Parent and Teacher Conner's Rating Scale and an     improvement in their Clinical Global Impression.      Method:      A total of 30-150 patients between ages of 6 and 15 y/o with diagnosis of ADHD according to     the DSM-IV-TR and on current treatment with stimulants recruited from CAOS-Maimonides Medical     Center and the Developmental Center will be evaluated by a child psychiatrist or a resident     under supervision of a child psychiatrist to make sure that the diagnosis is correct. Every     child will have a Conners Rating Scale filled out by the parents and teachers on admission to     the study. The evaluators will also fill out a Clinical Global Impression Scale (CGI).     Patients will be divided in two groups, one will consist of 15 children taking usual dose of     stimulants plus placebo and the other group, 15 children will receive the usual dose of     stimulant plus Lovaza at a dose of 1800mg daily. Both groups will be treated for 8 weeks.     Patients will be re-evaluated by investigators on week 2,4,6 and 8 of the study and on each     evaluation the parents and teachers will fill out a Conner's rating scale. Ratings of the     Conner's scales filled out for each patient will be analyzed and compared to the initial     evaluation after week 8. Evaluators will also obtain a CGI score for each visit. Patients     that improve will be taken off the stimulants and will continue further treatment with the     adjunctive therapy for a total of 4 more weeks, during this period of time, they will be     re-evaluated on weeks 9,10 and 12 and Conner's Scales will also be filled out by parents.      Patients who do not improve will be switched to the opposite treatment modality and will be     evaluated on weeks 9,10 and 12 also having Conner's Scales filled out by their parents. If     any of the patients in this group improve (after the switch) they will be taken off     stimulants and they will be evaluated on weeks 13,14 and 16 of the study arm.      The idea is to conduct the study and obtain information about prescription Omega-3 fatty     acids as an adjunct to stimulants for patients with ADHD, as several publications have been     done in the past suggesting it can be beneficial, but there have not been any conclusions on     whether the treatment is beneficial or not for this population.   "
156613|NCT01233843|"     The purpose of this study is to demonstrate that induction chemotherapy followed by radiation     therapy plus Cetuximab will give better results than the validated treatment     (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.   "
156614|NCT01233830|"     The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423     in young and elderly healthy Japanese volunteers.   "
156615|NCT01233817|"     The proposed feasibility study is necessary to test if children and young adults will     participate in and adhere to a 12-week, home-based, supervised progressive strength training     exercise program and to obtain preliminary data that will subsequently allow us to determine     the safety and impact of strength training in spinal muscular atrophy. Our pilot study will     address 3 aims: (1) Ascertain the feasibility of, and potential barriers to, participation in     and adherence to a 12-week home-based, supervised, progressive strength training exercise     program in children and young adults aged 5-21 years with SMA types II and III; (2) Determine     the safety and tolerability of progressive strength training in a pilot study sample of     children and young adults with SMA types II and III; and (3) Determine candidate outcome     measures.   "
156616|NCT01233804|"     The purpose of this study is to compare methods for consenting (opting in vs opting out) on     influenza vaccine uptake rate in pregnant women. This study is designed to learn about the     impact of influenza vaccination in pregnant women. This study will help gather knowledge     about influenza vaccine side effects (if given) and whether the vaccine reduces the number of     respiratory infection in mothers and their infants.   "
156617|NCT01233791|"     The purpose of this study is to determine whether vaginal diazepam suppositories are an     effective treatment of high tone pelvic floor dysfunction.   "
156618|NCT01233778|"     The objectives of this study are to examine how the consumption of treatment oils (including     canola oil, DHA enriched canola-oil, high oleic acid canola oil, flax oil, and safflower oil)     influence endothelial function, inflammation, oxidation, body composition, and plasma     lipoprotein characterization.   "
156619|NCT01233765|"     Recent scientific evidence suggests that the main defence cell of the body (neutrophil)     behaves in a different manner in patients with gum disease; namely how they interact with     bacteria and their role in defence systems of the body. This study proposes to examine these     responses in periodontitis patients and healthy controls.      The proposed study will include patients undergoing periodontal (gum) treatment who will be     matched to periodontally healthy controls. Blood, gingival crevicular (gum) fluid and     clinical measures will be collected both pre- and post-therapy to measure differences in cell     behaviour both before, and following routine therapy.      Blood samples will be used to isolate peripheral blood neutrophils prior to analysis of their     responses to different bacterial stimuli including oxygen radical, cytokine and extracellular     trap release. Gingival Crevicular Fluid samples will be used to measure different biochemical     markers that result from the production of Neutrophil Extracellular Traps (NETs). Routine     clinical measures will be taken both pre- and post-therapy as a measure of treatment     response.      Patient volunteers undergoing treatment will be asked to donate a total of four small samples     of tissue from the gums whilst they are already anaesthetised for routine treatment. These     will be approximately the size of a needle head (2mm2mm) and used to examine NET formation     within the tissues and related processes. This will provide novel in-vivo data regarding this     recently discovered method of neutrophil defence in innate immunity.      This proposal represents a novel study aimed at improving our current understanding of why     inflammatory periodontitis develops in some patients but not others, as well as providing     pointers to causal/noncausal relationships between periodontitis and important systemic     conditions such as diabetes and rheumatoid arthritis.      Ultimately, novel treatment approaches and primary prevention (for periodontitis) or     secondary prevention (for systemic disease) strategies may emerge.   "
156620|NCT01233752|"     Identification of the genetic polymorphisms that could be correlated either with a better     clinical response or with a major predisposition of patients to develop tolerance and/or side     effects to the treatment with morphine.   "
156621|NCT01233739|"     Patients who present rhizarthrosis diagnostic will be randomized to be treated with     chondroitin sulfate or placebo during 24 weeks to study the effect of the treatment with     objective and subjective indicators of pain and sensibility.   "
156622|NCT01233726|"     The aim of the study is to evaluate the beneficial effects of the administration of a     complete diet rich in monounsaturated fatty acids (MUFA) and slow absorption carbohydrate in     patients with stress hyperglycemia(T-Diet Plus Diabet IR).      The main objective of this project is to evaluate blood glucose metabolic control, insulin     requirements, insulin action resistance, lipid profile and to reduce infectious complications     on mechanical ventilation ICU (intensive care unit) patients after the administration of a     complete diet enriched in MUFA and slow absorption carbohydrates, without fructose.   "
156623|NCT01233713|"     The purpose of this multi-center randomized trial is to identify any differences in the     complication rates of patients undergoing Hartmann's (end colostomy) versus Primary     Anastomosis (with defunctioning ileostomy) for left-sided colonic performation (including the     stoma reversal operation).   "
156624|NCT01233700|"     The purpose of this study is to evaluate the potential effectiveness of a psychosocial     intervention based on the principles of motivational interviewing. The novel intervention     will assist living donor candidates to think through any remaining concerns or questions that     they may have about living donation. If the intervention is effective, it may help to prevent     post-donation problems related to psychological and health outcomes.   "
156625|NCT01233687|"     This is a phase I/II study of erlotinib and AMG 102 in previously treated subjects with     advanced NSCLC. Subjects will be enrolled with recurrent or progressive advanced stage NSCLC     that has been treated with at least one and a maximum of two prior chemotherapy regimens. The     Phase I part of the study will enroll 8-16 subjects with the Phase II part enrolling 21-45     subjects.      The Phase I part of the study is designed to determine how safest the combination of AMG 102     and erlotinib is and the recommended dose for the Phase II part. The Phase II part is to     determine whether the combination of AMG102 and erlotinib works enough to warrant further     interest in this combination.   "
156626|NCT01232634|"     The purpose of this study is to test the external validity of the systemic ultrasound     protocol for data acquisition and interpretation, in order to diagnose soft tissue and     osteochondral abnormalities in hemophilic children.   "
156627|NCT01232621|"     In the Approach Study, the investigators will study the 'process' by which Substitute     Decision Makers (SDMs) are approached for consent for their loved one's participation in     critical care research. The investigators will randomize SDMs of critically ill patients who     are eligible to participate in any research study in operation to either 'physician     introduction' of the research team or 'non-physician approach (non-physician)' in which     research coordinators are introduced by allied health care team members or introduce     themselves directly to SDMs. This study seeks to identify important features of the 'consent     to research' process that can be modified to enhance both SDM satisfaction with the consent     process and recruitment into critical care research studies.   "
156628|NCT01232608|"     Diabetes mellitus (DM) is an important risk factor in the development of cardiovascular     disease, and people with type 2 diabetes have a two- to four-fold increased risk for     cardiovascular morbidity and mortality. Physical activity is a well established therapeutic     modality for type 2 diabetes. In patients with coronary artery disease (CAD), several     clinical trials have shown reduced mortality and reduced progression of atherosclerosis with     lifestyle intervention including physical activity. But few studies have investigated the     effect of physical training in patients suffering from both diseases.      The aim of this study is to investigate the effect of one year of organized physical exercise     in patients with both coronary heart disease and type 2 diabetes on glucometabolic state and     progression of atherosclerosis.      The project is a randomized, controlled, open study on physical exercise. 136 patients will     be randomized at inclusion to a physical exercise group or a control group, the latter with     normal follow-up and not discouraged form physical activity. The intervention period will     be 12 months, and the physical training program will be developed and conducted in     collaboration with Norwegian School of Sport Sciences. The inclusion of patients started     summer 2010, the exercise program begins in September 2010 and the practical issues of the     study is planned to end during spring 2012.      The main hypothesis is that physical exercise improves the glucometabolic state and reduces     progression of atherosclerosis in patients with coronary heart disease and type 2 diabetes,     and secondary that physical exercise induces favourable changes in cardiovascular risk     factors, use of medication, and co-morbidity associated with diabetes.   "
156629|NCT01232595|"     This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in     patients who have moderate Clostridium difficile infections.   "
156643|NCT01232413|"     The objective of this study is to evaluate the effect of repeat oral dosing of ASP1941 on     electrocardiogram (ECG) measurements.   "
156644|NCT01233674|"     This study evaluates images obtained from a standard clinical cardiac MRI for evidence of     fibrosis.   "
156630|NCT01232582|"     Chronic pain affects an estimated 50 to 65 million individuals in the US, and its incidence     and prevalence is steadily on the rise in correspondence with the increasing longevity of the     population. Spinal pain, encompassing lower back, thoracic and neck pain, is a very common     type of chronic pain that can greatly reduce quality of life. Facet joint pain is most often     associated with facet arthropathy or degenerative arthritis of the joint. This condition     develops due to progressive wear and tear caused by the small but repetitive strain of the     joints throughout a lifetime. Strain and inflammation can induce fluid distention of the     joints which in turn can result in compression of the nerve roots of the joint - the origin     of the chronic pain.      Current treatments for facet arthropathy and pain include oral medications, intra-articular     injections of anesthetic or steroid medications, energy ablation (e.g. radiofrequency     ablation) for denervation, and in some severe cases facet rhizotomy (surgical severing of the     nerves).      The ExAblate magnetic resonance guided focused ultrasound system enables noninvasive focal     ablation of tissue. Results from feasibility studies, including those from the FDA approved     feasibility study (IDE # G050177) have shown the palliative effect of the ExAblate for     patients with bone metastases. It is reasonable to assume that this palliative effect of     MRgFUS could also translate to the alleviation of facet pain if focused ultrasound beams are     directed to the facet joints. The highly-target focal ablation could also diminish the risk     of complications that are often associated with other less selective denervation techniques.      The objective of this trial is to evaluate the safety and effectiveness of the ExAblate     system and the treatment of pain resulting from facet joint osteoarthritis.   "
156631|NCT01232569|"     This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the     reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in     combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with     active, moderate to severe rheumatoid arthritis. In the double-blind part of the study,     patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously     every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study,     patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from     Week 24 to Week 96 using a pre-filled syringe or an auto-injector.   "
156632|NCT01232556|"     The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab     in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for     intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of     this combination compared with an active comparator arm (investigator's choice of     rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall     survival.   "
156633|NCT01232543|"     The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are     administered Product 0405 for the treatment of Atopic Dermatitis   "
156634|NCT01232530|"     This is a phase IV open label study assessing the safety and effectiveness of artemisinin     derivatives-based combination therapy (ACT) when used on a large scale and under real life     conditions.   "
156635|NCT01232517|"     The purpose of this research study is to gather information about the NeuroVision System     (which is FDA cleared for this indication) during the placement of pedicle screws.     NeuroVision is a machine that monitors nerve activity during surgery and will alert the     surgeon if there are any nerve-related issues during screw placement. The use of nerve     monitoring is standard of care at most centers during spine surgery. The standard monitoring     for screws placed is performed after the screw is placed, to ensure it is well positioned in     the bone (if it is not, the screw may be removed and/or repositioned). The NeuroVision System     has a novel feature called Dynamic Screw Test that allows for that monitoring to be     performed as the screw is placed, rather than after the fact. This study is being done to     determine if this real-time monitoring of screw placement provides beneficial additional     information to the operating surgeon to prevent misplacement of screws before it happens.   "
156636|NCT01232504|"     We conducted a prospective, multicenter, open-label randomized trial to compare the     antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF),     Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and     rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.   "
156637|NCT01232491|"     This trial is conducted in Europe, and North and South America. The aim of this trial is to     investigate if a dietary intervention has an effect on weight when initiating insulin     treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs     (OADs).   "
156638|NCT01232478|"     The iCARE study, a clustered-randomized controlled trial, is evaluating an adherence     promotion intervention for adolescents that Cystic Fibrosis (CF) care teams will implement.     Half the centers will receive the Comprehensive Adherence Program (CAP) for 2 years. CAP     consists of training in the CF My Way program (a validated problem-solving adherence     promotion intervention). The other half of the centers will receive CAP in year 2 of the     study. Participants are patients age 11-20 years old who are diagnosed with CF and have been     prescribed at least one of the following medications for at least 6 months prior to signing     the informed consent: azithromycin, hypertonic saline, Pulmozyme®, TOBI®, or inhaled     compounded tobramycin. Rate of refilling prescriptions is the primary outcome with lung     function decline rates, exacerbation rates, and patient reported measures including health     related quality of life and CF knowledge and skills, as secondary outcomes.      A central goal of this study is to test the effectiveness of the comprehensive adherence     program (CAP), described above, versus standard care (SC) for adolescents and young adults     seen in outpatient CF clinics.   "
156639|NCT01232465|"     Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients     undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any,     between IVF success and sperm DNA integrity.   "
156640|NCT01232452|"     The primary purpose of this study is to evaluate the hypothesis that cixutumumab given in     combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as     first-line therapy for patients with advanced nonsquamous non-small cell lung carcinoma     (NSCLC).   "
156641|NCT01232439|"     To measure the occupancy of brain kappa opioid receptors after single oral doses of     LY2456302.   "
156645|NCT01233661|"     We intend to examine the effects of temporary elevation of atrial wall stress by shortening     of the atrioventricular delay in patients with dual-chamber pacemakers.   "
156646|NCT01233648|"     This study is being done to find out if controlling rate or controlling rhythm is better for     heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device     and AV node ablation as part of their clinical care will be followed for one year. One group     will have their heart rate controlled by the ICD and AVN ablation alone and the second group     will be treated with the ICD, AVN ablation and standard medical therapies to restore the     heart's normal rhythm. The study doctors will compare the information collected from all of     the subjects in this study to see if treating rate or treating rhythm is better in patients     with heart failure and AF, resulting in a better quality of life.   "
156647|NCT01233635|"     In the present application, we propose to refine and extend current insight into AAF     mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE     genotype, and their interaction in secondary AF prevention. We have 3 specific aims:        1. To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.        2. To test the hypothesis that the incidence of AF recurrence in the absence of RAAS          inhibition therapy is higher among patients with the D allele.        3. To explore the hypothesis that RAAS inhibition therapy is more effective for preventing          AF recurrence in patients with the DD genotype than in those with DI or II genotypes.   "
156648|NCT01233622|"     This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy     to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).   "
156649|NCT01233609|"     The objectives of this study are to evaluate the efficacy of Valproic Acid (VPA) to both slow     the progression of visual function loss and/or to restore visual function in patients with     Autosomal Dominant Retinitis Pigmentosa (RP) and to collect safety and tolerability     information.   "
156650|NCT01233596|"     The aim of the study was to compare the success rate of monocanalicular intubation versus     bicanalicular silicone intubation in congenital nasolacrimal duct obstruction in children     aged between 10 and 36 months.   "
156651|NCT01233583|"     The aim of this study is to understand which therapies will suppress effector cells and     promote regulatory T cells and To test whether patients with a better response to therapy and     longer psoriasis-free periods develop a higher numerical ratio of regulatory to effectors     T-cells and/or regulatory cells more able to suppress the effectors.   "
156652|NCT01233570|"     An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns     disease   "
156653|NCT01233557|"     Biomarkers of bone resorption will be measured in the blood of patients with bone metastases     from prostate cancer during the course of their illness. Changes in these biomarkers will be     correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the     response and/or progression of their cancer. It is hoped that serial measurement of these     biomarkers may allow therapeutic monitoring in the future with successful individualisation     of bisphosphonate therapy for metastatic prostate cancer.   "
156654|NCT01233544|"     This randomized clinical phase III trial is testing the efficacy of radiofrequency ablation     (RFA) and stereotactic body radiotherapy (SBRT) in the treatment of colorectal carcinoma     liver metastases.      Primary end point is local progression free survival.   "
156655|NCT01233531|"     Cash transfers to young women for staying in school and its effect on acquiring HIV   "
156656|NCT01233518|"     This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and     Asian centers designed to determine the diagnostic performance of CT-FLOW (the     investigational technology) by coronary computed tomographic angiography (CCTA) for     non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to     direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a     reference standard.   "
156657|NCT01233505|"     This phase I trial is studying the side effects and the best dose of veliparib when given     together with capecitabine and oxaliplatin in treating patients with advanced solid tumors.     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving veliparib together with capecitabine and oxaliplatin may kill more tumor     cells.   "
156658|NCT01233492|"     RATIONALE: Giving boron phenylalanine in different ways and measuring it in tissue in     patients with glioblastoma multiforme may help in planning better radiation therapy, such as     boron neutron capture therapy, for patients in the future.      PURPOSE: This phase I trial is studying the side effects, best dose boron phenylalanine, and     best way of giving it with or without mannitol in treating patients with glioblastoma     multiforme.   "
156659|NCT01233479|"     RATIONALE: Studying samples of blood in the laboratory from patients receiving radiation     therapy and chemotherapy may help doctors learn more about the effects of this treatment on     cells. It may also help doctors understand how well patients respond to treatment.      PURPOSE: This research study is studying biomarkers in blood samples from young patients with     newly diagnosed brain tumors undergoing standard radiation therapy and chemotherapy.   "
156660|NCT01233453|"     This is a prospective, randomized, multi center study. Approximately 2700 patients will be     entered in the study and will be randomized on a 2:1 basis. Patients who meet the eligibility     criteria will be randomized to the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS®     stent versus the Biolimus A9 eluting NOBORI® stent. Patients will be followed for 5 years.   "
156661|NCT01233440|"     The primary objective of the study is to assess the safety of IV administration of rIX-FP.     Safety will be evaluated by adverse events and laboratory changes over time. The secondary     objective of the study is to evaluate the pharmacokinetics parameters, following a single     intravenous dose of rIX-FP.   "
156662|NCT01233427|"     Characterize a population-based sample of first-time expectant mothers with regards to     maternal metabolic health and their infant feeding experience.   "
156663|NCT01233414|"     The purpose of this 24 week study is to determine whether a new Parent Training program is     effective in reducing disruptive behaviors in young children with pervasive developmental     disorders.   "
156664|NCT01233401|"     This study evaluates whether offering Tetanus, diphteria and acellular pertussis (Tdap)     vaccine to caregivers of newborn infants during pediatric well child visits increase the     caregivers' vaccination rates.   "
156668|NCT01233349|"     Preparations that bind to nutritional fat and inhibit its absorption could be decisively     meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble     fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after     eating. Such effects are supposed to facilitate adherence to energy-restricted diets. The     medical device to be investigated contains a patented formula of fibre complex having a high     ability to bind to dietary fat.      Therefore, the rationale for this study is to confirm that Litramineʼs proven fat binding     capacity to increase fat excretion and modulate the feeling of satiety will translate into     measurable reduction in body weight. A double blind, randomized, placebocontrolled design has     been chosen to assess the efficacy and safety of Litramine in overweight and obese subjects     on a energy-restricted diet.   "
156669|NCT01233336|"     This is the continuation of previous study (registration number: NCT00844987) which revealed     that hepatocyte growth factor (HGF) is a very early, good marker of myocardial injury and     prognostic factor for post myocardial infarction (MI) cardiovascular events presence in     long-term follow-up. Due to potentially very important implication of the results of previous     study it was decided to continue research of HGF in patients with MI. Now, is scheduled to     examine 100 consecutive patients with STEMI. HGF assessments will be performed just after     admission to hospital, 1h and 24h later and before discharge. Two follow-up visits were     planned i.e. at 3 and 6 months after MI. During hospitalization and at 6 month visit the     echocardiography examination will be performed. The composite primary endpoint consists of     cardiovascular events observed during hospital course and in long term-follow-up.   "
156670|NCT01233323|"     The purpose of this study is to collect sensor data from patients with implanted cardiac     resynchronization devices who exhibit phrenic nerve stimulation.   "
156671|NCT01233310|"     Study Hypothesis:      It is estimated that by re-programming some of the PillCam COLON2 system parameters it can     serve as tool for visualizing both small bowel and colon. As such, the system may be utilized     in CD patients for monitoring mucosal healing.      Primary objectives:      To evaluate two different video output methods in the visualization of the SB and colon in CD     patients      Secondary objectives:        -  Evaluate the level of agreement between PillCam system and ileocolonoscopy on the          assessment of CD findings.        -  Evaluate the effectiveness of PillCam regimen in CD patients      Inclusion criteria        -  Patient is 18 years of age and above        -  Patient with a diagnosis of ileocolonic or colonic Crohn's Disease documented by          endoscopical, histopathological and/or radiological parameters        -  Patients' CDAI >150.        -  Patient is clinically indicated to undergo ileocolonoscopy for assessment of Crohn's          disease        -  Proven patency by Agile capsule or another approach deemed clinically acceptable by the          investigator, e.g. CT enterography, performed within the 3 months prior to enrollment        -  Patient is able and agrees to sign the Informed Consent Form      Exclusion criteria        -  Patient has dysphagia        -  Patient has congestive heart failure        -  Patient has renal insufficiency        -  Patient has cirrhosis        -  Patient is known or is suspected to suffer from intestinal obstruction        -  Patient has known previous stricture/obstruction of the SB or colon        -  Patient has taken NSAID medications less than one month before enrollment        -  Patient suffers from hypertension and is taking one or more of the following medications          used for control of hypertension: diuretics, ACE inhibitors, Angiotensin II blockers        -  Chronic use of laxatives        -  Patient has a cardiac pacemakers or other implanted electro medical devices.        -  Women who are either pregnant or nursing at the time of screening, who intend to be          during the study period, or are of child-bearing potential and do not practice medically          acceptable methods of contraception.        -  Patient is expected to undergo MRI examination within 7 days after ingestion of the          capsule.        -  Patient has had prior abdominal surgery of the gastrointestinal tract other than          uncomplicated procedures that would be unlikely to lead to bowel obstruction based on          the clinical judgment of the investigator.        -  Patient has any condition, which precludes compliance with study and/or device          instructions.        -  Patient suffers from life threatening conditions        -  Patient is currently participating in another clinical study        -  Patient has known slow gastric emptying time        -  Patient is allergic or contraindicated to any of the study medications   "
156672|NCT01233297|"     Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to     viral infection. The current study will examine whether treatment of asthmatic exacerbations     with macrolide antibiotics - in the abscence of clear clinical bacterial infection which     would in any case precipitate antibiotic treatment - has an effect on either the particular     episode, or subsequently. Macrolide antibiotics are chosen for ease of administration     ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.   "
156673|NCT01233284|"     Rationale for the current trial is to evaluate the efficacy and safety of three doses (1.25     µg, 2.5 µg and 5.0 µg ex mouthpiece) of tiotropium inhalation solution in patients with     moderate persistent asthma who are still symptomatic despite regular maintenance therapy with     inhaled corticosteroids (ICS).      The data collected in the present trial will provide useful information to health care     providers and patients regarding the efficacy and safety of a once daily inhalation of three     different doses of tiotropium solution delivered by the Respimat® inhaler in addition to     inhaled corticosteroids in the treatment of not fully controlled moderate asthma in     comparison to placebo. The Pharmacokinetics (PK) of tiotropium is well established in COPD     patients. However, there is currently no PK data available for the 3 doses of tiotropium     being tested in this trial in patients with moderate persistent asthma. Tiotropium is a once     daily drug. Hence, the rationale for blood and urine sampling for PK analysis over 24 hours     in a subset of patients is to confirm the PK of the 3 doses in moderate asthma patients.     Rationale for the 24-hour pulmonary function test sub-investigation is to demonstrate that a     once daily dosing of tiotropium inhalation solution is effective and safe in the treatment of     moderate persistent asthma.   "
156674|NCT01233271|"     Hyperglycemia is common in critically ill patients and associated with an adverse outcome.     Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of     the intensive care unit staff difficulties were experienced in achieving efficient and safe     glucose control. A fully automated algorithm may help to overcome some of these limitations     by excluding intuitive interventions and integrating relevant clinical data in the     decision-making process. Space GlucoseControl (TGC system) is a decision support system which     helps to achieve safe and reliable blood glucose control in the desired ranges. Information     on parenteral and enteral nutrition is automatically integrated into the calculations. The     primary objective of the current study is to investigate the performance and usability of the     Space TGC system for glucose control over an extended glucose control range (4.4 to 8.3     mmol/L) in postoperative cardiac surgery patients.   "
156675|NCT01233258|"     The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with     BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe     Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand     treatment.   "
156676|NCT01233245|"     This is an observational survey to assess the factors that influence adherence to Betaferon     therapy in multiple sclerosis patients using elements of the BetaPlus support program,     including the nurse support and auto-injectors. The patients were evaluated under normal     clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping     processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.   "
156679|NCT01233206|"     The use of metformin pre-treatment and co-administration was recently proposed in infertile     women affected by polycystic ovary syndrome (PCOS) treated with gonadotropins.      Data from meta-analyses showed that metformin administration significantly reduced the     stimulation length and the total dose of gonadotropins used in PCOS women undergoing     gonadotropins stimulation for non in-vitro fertilization (IVF) cycles. On the other hand, in     IVF cycles metformin was demonstrated to significantly reduce the ovarian hyperstimulation     syndrome (OHSS) rate in infertile patients with PCOS treated with gonadotropins.      The metformin regulating effect on the ovarian response was also observed in a randomized     controlled trial (RCT) on young non-obese insulin-resistant women with PCOS receiving     gonadotropins for mono-ovulation induction. In particular, metformin increased the     mono-ovulatory cycles, the duration of stimulation and the amount of gonadotropins used,     while it reduced the number of dominant follicles and the estradiol (E2) levels.      The aim of the present study was to evaluate the effect of metformin administration in high     responder PCOS patients undergoing gonadotropins ovarian stimulation for IVF cycles.   "
156680|NCT01233193|"     The purpose of the study is to test if a Pharmacist Intervention Program with home blood     pressure monitoring (HBPM) improves or controls pharmacological adherence and blood pressure     levels in hypertensive patients under pharmacological treatment, compared to those who     receive usual care in a community pharmacy setting.   "
156681|NCT01233180|"     Gua Sha massage is a traditional chinese medical treatment. It is mostly used in the     treatment of the common cold and pain syndromes. Gua Sha involves pressuring the skin by a     round-edged instrument until small petechiae appear. This so called sha, considered as the     removal of blood stasis by traditional practitioners, will fade within a few days. Normally,     this treatment is not considered as painful, but as relaxing and easing tense muscles.      In this study, the investigators will investigate the effectivity of Gua Sha massage in     treating chronic neck pain. The investigators will research effects on subjective pain     intensity, neck pain specific disability and haptic perception.   "
156682|NCT01233167|"     The study aims to assess the effectiveness of dual antiplatelet therapy, aspirin alone versus     steeply discontinued clopidogrel plus aspirin in preventing clinical MACE events.Our subject     is beyond a 12-month period patients receiving sirolimus drug-eluting stent implantation.   "
156683|NCT01233154|"     Various studies in animal and humans have shown a potential beneficial effect of probiotics     consumption on allergy. However few studies exist that document their efficacy for upper     airways allergies such as allergic rhinitis. The objective of this study is to investigate     the effect of short-term oral administration of a L. paracasei or of a blend of 2 probiotics     (L. acidophilus + B. lactis) on a nasal provocation test (NPT) with grass pollen, performed     out of the pollen season. Adult volunteers with allergic rhinitis are enrolled in a     randomized, double-blind study, based on two 4-weeks cross-over periods of product     consumption separated by a washout period of 6-8 weeks. Objective and subjective clinical     parameters of NPT as well as systemic and nasal immunological markers are compared before and     after each treatment.   "
156684|NCT01233141|"     The rationale of this study is to establish a registry to detect and follow patients with CLI     treated in Vienna. The Vienna CLI registry is meant to document the incidence, prevalence,     and actual outcome of CLI patients in a real world setting and should serve as a tool for the     evaluation of medical, endovascular and surgical interventions. It will help determining the     prognosis of individual patients and have impact on economic and political decisions in     Vienna concerning this disease and the related costs.   "
156685|NCT01233128|"     This study is to investigate whether there is an association of the LOC387715/HTRA1 and     vascular endothelial growth factor polymorphism with response to treatment with intravitreal     ranibizumab injections for patients with polypoidal choroidal vasculopathy.   "
156686|NCT01233115|"     This study is to investigate whether there is an association of the LOC387715/HTRA1 variants     with response to treatment with combined photodynamic therapy and intravitreal bevacizumab     for patients with polypoidal choroidal vasculopathy.   "
156687|NCT01233102|"     The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem     cells (MSCs) transfusion in the treatment of liver cirrhosis. Liver function will be     monitored by serum analysis. The levels of serum alanine aminotransferase (ALT), total     bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at     pre-transfusion, and 3 days to 2 years post-transfusion. Child-Pugh scores, Model for     End-Stage Liver Disease scores and clinical symptoms will be assessed simultaneously.   "
156688|NCT01233089|"     The purpose of this three-month study is to compare the quality of life and ease of fit among     children wearing investigational single-vision contact lenses, commercially marketed     single-vision contact lenses, and commercially marketed multifocal contact lenses.   "
156689|NCT01233076|"     The purpose of this study is to evaluate the performance of two commercially marketed daily     disposable contact lenses in a population of daily disposable contact lens wearers.   "
156690|NCT01233063|"     The trial will test whether the Alive email-delivered health behavior program can improve     subjects' physical activity, fruits and vegetables and saturated/trans fats and added sugars.   "
156733|NCT01232231|"     The purpose of this study is to determine the effectiveness of topical and oral antibiotics     in eliminating carriage of methicillin-resistant Staphylococcus aureus (MRSA) among those     living in the community. We hypothesize that a greater proportion of those who receive     intervention will eliminate MRSA carriage compared to those who do not receive any     intervention.   "
156701|NCT01232920|"     The proposed study is a masked trial, with stratified block randomization by site, designed     to determine which treatment, methotrexate or mycophenolate mofetil, is more effective as     first-line steroid-sparing treatment for patients with non-infectious uveitis requiring     corticosteroid-sparing therapy.      One hundred non-infectious uveitis patients in need of corticosteroid-sparing therapy will be     randomized to receive either oral methotrexate or oral mycophenolate mofetil at Aravind Eye     Hospitals (Madurai and Coimbatore, South India). They will be followed monthly for 6 months     after enrollment or until treatment failure. The investigators hypothesize that the     proportion achieving corticosteroid-sparing success at 6 months for patients taking     mycophenolate mofetil will be improved in comparison with patients taking methotrexate.   "
156691|NCT01233050|"     Surgical site infections (SSI) are one of the most common complications in the post-operative     patient, and the second most common health care associated infection overall. It is estimated     that there are between 500 thousand and 1.1 million surgical site infections in the United     States each year. Given the magnitude of the problem, prevention of surgical site infections     is a major goal of peri-operative care. However, skin preparation prior to surgery has not     been as rigorously examined. The primary objective of this study is to compare the efficacy     of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate /     70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol in     the prevention of superficial surgical site infection. Male and female patients, age 18 years     and older undergoing elective colorectal surgical procedures involving a laparotomy will be     enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at     regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI.     Patients will remain enrolled into the study until 35 days postoperatively.   "
156692|NCT01233037|"     This is a non-randomized feasibility study of endothelial function, exercise capacity, and     outcome following pre-left ventricular assist device (LVAD)therapy and cardiac transplant.      The study period will be 5 years, with 20 patients to be enrolled. The investigators     anticipate that 15 patients will survive to complete the one year follow up period.(the     published survival rate of LVAD is 75% in one year). 10 patients are anticipated to undergo     cardiac transplant within 3 years of initial enrollment and they are followed until their 2nd     annual post transplant invasive evaluation.      Markers of endothelial function will be studied to permit comparison with selected clinical     outcomes. The hypothesis is that the endothelial functions will be altered after implantation     of LVAD then before its implantation, both acutely and chronically, and this may affect the     exercise capacity, quality of life and occurrence of cardiac allograft vasculopathy post     cardiac transplantation.   "
156693|NCT01233024|"     Studies have found a relationship between dietary fiber consumption and body weight     regulation. This relationship may stem from enhanced satiety through fermentation of certain     fibers in the large intestine.      The objective of this study is to determine and compare satiety ratings, changes in food     intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble     corn fiber, and resistant starch.   "
156694|NCT01233011|"     The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically     engineered for use both as a standalone laryngeal mask airway (LMA) and as a rescue device or     Plan B device in the event of a difficult airway. As with some other types of LMA, it is     then possible to insert an endotracheal tube (ETT) through the Air-Q® ILA, either blindly or     mounted on a fibreoptic bronchoscope (FOB), to achieve endotracheal intubation. This will be     a prospective observational study of the Air-Q® ILA's performance.   "
156695|NCT01232998|"     The investigators want to survey Emergency Department Patient Satisfaction in the Imam Reza     hospital ,Tabriz ,Iran by questionnaire form . Finally the investigators want to improve the     quality services in the department based on the research result.   "
156696|NCT01232985|"     The purpose of this study is to find out if investigational device, RD047-26, is safe and     useful for the treatment of mild to moderate atopic dermatitis.   "
156697|NCT01232972|"     The purpose of this investigation is to offer the opportunity for young women to cryopreserve     (freeze) their oocytes (eggs) for use with IVF at a later point in time.   "
156698|NCT01232959|"     Today there are three different ways to remove a gallbladder with gallstones. Surgeons can     remove the gallbladder through small incisions in the abdomen. This is called laparoscopic     cholecystectomy. It is the current standard. It has replaced traditional open gallbladder     surgery. Open gallbladder surgery is done with a large incision. A new way of removing the     gallbladder in women is through the vagina. This is called transvaginal cholecystectomy. This     study is being done to see if removing the gallbladder through the vagina will work for     patients at Mayo Clinic Rochester. This is the first step of this research to test the     procedure. In the future, other studies will examine the potential for less scarring and     reduced pain. In this study the investigators will still make small incisions in the abdomen,     they will be smaller than the standard procedure but you will still have some scars on your     abdomen.      Some very early research reports say that some patients may have less pain with the     transvaginal approach; however, the investigators do not know if the transvaginal route will     have any effect on your overall health and quality of life.      This study will evaluate:        -  Effectiveness of the surgery: ability to remove the gallbladder safely        -  Effect of the operation on your body: change in pulse and blood pressure during the          surgery, level of inflammation markers in your blood before and after the surgery        -  Recovery from surgery in the hospital: how much pain you have, how much pain medication          you need, how long you need to stay in the hospital, or nature of any surgical          complications (problems)        -  Overall recovery from surgery: general quality of life, abdominal symptoms      What is the new type of surgery?      The new type of surgery is called transvaginal cholecystectomy:      A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is     inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A     very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps     the surgeons to remove your gallbladder through the vagina. The procedure to separate your     gallbladder from your body will be assisted by instruments placed through your abdomen and     instruments placed in your vagina. The surgeon will remove the gallbladder by passing it     though your vagina.   "
156699|NCT01232946|"     The investigators will test the hypothesis that effects of liraglutide plus insulin detemir     on myocardial fuel selection will be greater than the effects of either agent alone. 27 Type     2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with     oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin     detemir, liraglutide, or liraglutide plus detemir (9 subjects per group). All subjects will     undergo an initial standardization of background treatment to metformin 2000 mg per day,     followed by randomized assignment to 3 months' treatment with liraglutide 1.8 mg/day (once     daily each morning, tapering up according to label instructions) and/or detemir (administered     twice daily, initially at 10 units per day then titrated to achieve fasting morning glucose     readings below 130 mg/dL). PET measurements of myocardial fuel selection will take place at     the end of this treatment period, under fasting conditions in the morning following that     day's treatment injection(s).   "
156700|NCT01232933|"     Subjects meeting study requirements will be consented and have their PICC catheter placed     using navigational technology and the tip placement confirmed with radiographic imaging.   "
156734|NCT01232218|"     The purpose of this study is to determine if a specific stretching and strengthening     protocol, in addition to current standard treatment, is more effective for treating     post-stroke shoulder pain than current standard treatment alone.   "
156735|NCT01232205|"     The purpose of this study is to investigate the benefit of several micro nutrients of     antioxidants (using milk) in a cohort of women with low antioxidant status and the changes in     cell-free mRNA.   "
156736|NCT01232192|"     The purpose of this study is to determine whether antenatal model in vaginosis are effective     in preventing vaginal infection and preterm delivery   "
156702|NCT01232907|"     1. Purpose: To explore the use of L-Carnitine, a pharmaceutical product, for the treatment          of fatigue in persons with spinal cord injury (SCI).        2. Hypothesis: Similar to previous research in disabled and aging populations, the          investigators hypothesize that treatment with L-Carnitine will result in a significant          improvement of clinical fatigue in spinal cord injury clients, effecting a decrease on          the Fatigue Severity Scale (FSS) of 0.5 points or more. The investigators expect to see          an effect after approximately three weeks of treatment.      As secondary outcomes, the investigators expect to see positive changes in the Centre for     Epidemiologic Studies Depression Scale (CES-D)and Visual Analogue Fatigue (VAS-F) and Visual     Analogue Pain (VAS-P) scores, due to a combination of previously demonstrated effects of     L-Carnitine directly on pain and depression, and the effects of the potential decrease in     fatigue.   "
156703|NCT01232894|"     In this 12-week study, patients were randomized to either open-label indacaterol or standard     of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were     assessed.   "
156704|NCT01232881|"     This is a tumor and serum collection study for patients with advanced breast cancer receiving     treatment with lonafarnib.   "
156705|NCT01232868|"     Vaccination is the most effective way of preventing infectious diseases. Despite the success     of vaccines in general, vaccines induce diminished antibody responses and lower protection in     the elderly in particular. This could be explained by a defect in the early responses of an     ageing immune system. A better understanding of the basic immunological mechanisms that     mediate vaccine efficacy is incomplete. Such information is critical and could greatly     decrease both the cost and the time to new vaccine development particularly for the geriatric     population.      In this trial, the investigators will study the immunologic differences of an FDA approved     licensed influenza vaccine between a younger and an older group. Twenty two healthy     volunteers between the age of 25-40 and forty four healthy volunteers above the age of 65     will be enrolled in the study. Each participant in the study will be given one flu shot.     Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen     days, as well as one month and six months after vaccination. Throughout the duration of the     study, the participants will be monitored for safety.   "
156706|NCT01232855|"     RATIONALE: Studying samples fo tissue from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in tissue samples from patients with     acute promyelocytic leukemia.   "
156707|NCT01232842|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in tissue samples from patients with     acute myeloid leukemia.   "
156708|NCT01232829|"     This phase II trial is studying how well RO4929097 (gamma-secretase/Notch signalling pathway     inhibitor RO4929097) works in treating patients with previously treated metastatic pancreatic     cancer. RO4929097 may stop the growth of tumor cells by blocking some enzymes needed for cell     growth.   "
156709|NCT01232816|"     Delayed graft function (DGF) increases risk of acute rejection after kidney transplantation     (KTx). Interleukin-6, which is produced in DGF, is critical in directing naive T helper cells     differentiation towards T helper 17 (Th17) and away from regulatory T (Treg) cells. The     investigators hypothesize there is an increase in Th17 and a decrease in Treg expression in     KTx recipients with DGF compared to those without, leading to immunologic consequences. The     investigators will test their hypothesis by measuring in both groups expression of Th17,     Treg, and related cytokines in blood, urine, kidney biopsy, and kidney preservation fluid,     and correlating these results with immunologic events.   "
156710|NCT01232803|"     MTN-007 is a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study     of vaginally formulated tenofovir 1% gel (a reduced-glycerin formulation), when applied     rectally. The primary objective of this study is to assess the safety of vaginally formulated     tenofovir 1% gel when applied rectally.      After completing screening and baseline evaluation, eligible participants will be randomized     to receive tenofovir 1% gel, 2% nonoxynol-9 gel (N-9) or placebo gel. The study will also     include a no treatment arm. There will be 15 participants in each arm.      Participants will return to the clinic, where they will self-administer a single dose of the     study gel under observation. Within approximately 30 minutes, lavage, stool, and rectal     biopsy specimens will be obtained. After a one-week recovery period, participants will return     to the clinic for assessment. If no significant adverse events (AEs) are reported they will     begin to self-administer once-daily outpatient doses of the study gel for 7 days.     Participants will return to clinic for evaluation and specimen collection after completion of     7 days of daily dosing.   "
156711|NCT01232790|"     The purpose of this study is to evaluate the effects of the amino acid supplement     N-Acetylcysteine versus placebo on working memory and other cognitive functions in persons     with a diagnosis of schizophrenia.   "
156712|NCT01232777|"     The purpose of this study is to determine whether a single intravitreal (into the gel of the     eye) injection of Avastin 0.625mg or 0.75mg is equivalent (non-inferior) to treatment with     standard of care laser in infants with Type I pre-threshold retinopathy of prematurity (ROP)     diagnosed at 30-36 weeks gestational age.   "
156896|NCT01230060|"     The objective of this study is to evaluate the safety and effectiveness of the enVista®     One-Piece Hydrophobic Acrylic intraocular lens (IOL), following primary implantation for the     visual correction of aphakia in adults 18 years of age or older in whom the cataractous lens     has been removed by an extracapsular cataract extraction method (eg, small incision     phacoemulsification).   "
156797|NCT01231399|"     RATIONALE: Everolimus may stop the growth of stomach or esophageal cancer by blocking blood     flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing, or by stopping them from spreading. Giving     everolimus together with combination chemotherapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when     given together with combination chemotherapy in treating patients with metastatic stomach or     esophageal cancer that has spread to other places in the body.   "
168447|NCT00033085|"     The purpose of this study is to assess the efficacy and safety of ondansetron to reduce     cocaine use in subjects with cocaine dependence.   "
156713|NCT01232764|"     The purpose of this study is to evaluate the effectiveness of 'enhanced' multi-disciplinary     wound care teams (MDTs) vs. 'usual' care teams in Long Term Care (LTC) facilities in Ontario     for the treatment of pressure ulcers. LTC facilities with more than 100 beds that are within     a 100 km distance from St. Mikes and have a problem with pressure ulcers will be asked to     participate. A total of 10 LTC facilities will be randomly selected (i.e. selected by chance)     from those that agree to participate.      The 'enhanced' MDT will be an Advance Practice Nurse(APN) with expertise in wound care who     has direct access to the wound care team at St. Mikes. This APN will develop treatment plans     in consultation with facility staff, providing targeted pressure ulcer treatment education on     an ongoing, case by case basis. Care is supported by telemedicine with the use of digital     photography and online communication between members of the care team.      This study is a stepped wedge randomized trial, meaning LTC facilities are assigned to a     start date for this study totally by chance. Changes in healing rates, wound related pain,     cost, number of new pressure ulcers, and number of wounds healed will be measured before, and     after the APN is introduced to facilities. In order to gain more insight into how people felt     about this model of care, interviews will be held with individuals and groups of staff at 5     randomly selected facilities before, during, and after the study has been completed.   "
156714|NCT01232751|"     Alleged benefits experienced by the consumption of soy in Asian countries have been     attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones are     believed to relieve menopausal symptoms and are therefore often consumed in supplement form     in Western countries. These supplements contain relatively high amounts of isoflavones, and     the question is if these concentrations still exert beneficial effects or whether negative     effects become dominant. Therefore, the investigators will study the effect of intake of one     dose of isoflavones, as compared to placebo, for eight weeks on gene-expression in Peripheral     Blood Mononuclear Cells (PBMCs) in post-menopausal, equol-producing women.   "
156715|NCT01232738|"     ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons     in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and     loss of muscle function. While there are drugs to help relieve symptoms of ALS, there is no     cure for ALS.      Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means     that the nervous system may be protected against weakening. It is known that rasagiline has     possible neuroprotective characteristics and it is approved for use for patients with another     disorder, the effectiveness of rasagiline for patients with ALS has not been tested.   "
156716|NCT01232725|"     Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all     infants, optimizes intellect, and provides protection against infectious and atopic diseases     in childhood as well as decreasing risks for obesity, hypertension and other chronic     diseases. Infants with the highest risk of life-long disability, very low birthweight (VLBW)     preterm infants, are breastfed at some of the lowest rates in the US. Maternal milk is not     always available, and pasteurized donor human milk is an alternative that requires     investigation. Whether donor milk conveys health and developmental advantages similar to     those bestowed by maternal milk is unknown. By determining the effects of donor milk on     health and developmental outcomes when compared to preterm infant formula, the investigators     seek to optimize outcomes in this fragile population. The hypothesis of our donor milk     research is that a donor human milk diet in non-maternal milk fed VLBW infants is associated     with better neurodevelopmental outcome scores at 18-22 months adjusted age than a preterm     infant formula diet.   "
156717|NCT01232712|"     The scientific approach behind this study is to develop novel anti-cancer therapeutic vaccine     to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes     populations and can be be applicable to the majority of the target population.   "
156718|NCT01232699|"     Internet-based weight control programs have been shown effective in producing weight loss,     but in-person delivery of behavioral weight control produces significantly greater weight     loss than on-line delivery of the same program. Motivational Interviewing has been shown to     increase weight loss when delivered as an adjunct to in-person weight loss programs but has     not been examined in conjunction with web-based obesity treatment. Therefore, the overall     goal of this project is to determine if the addition of on-line Motivational Interviewing to     a web-based group behavioral obesity treatment program will augment weight loss outcomes.   "
156719|NCT01232686|"     The study investigates whether shared online access to epidemiological data for general     practitioners, disease prevention officers, emergency care services and microbiology     laboratories changes clinical practice with regard to testing, diagnosing and treatment of     communicable diseases. The main hypothesis is that online access for general practitioner to     epidemiological data about communicable diseases changes clinical practice for testing,     diagnosing and treatment of communicable diseases.   "
156720|NCT01232400|"     The purpose of this study is to evaluate the clinical effect of esmolol treatment on cardiac     function and electrophysiology; to assess the effects of esmolol treatment on serum     adrenergic and cardiac biomarkers; to explore the safety of esmolol treatment shortly after     subarachnoid hemorrhage (SAH). Patients will be followed for a maximum of 1 month after the     index SAH. The primary outcome will be change in systolic function - ejection fraction by     Simpson's rule (baseline versus Day 7 +/- 2 after SAH).   "
156737|NCT01232179|"     Proliferative diabetic retinopathy (PDR) is treated with conventional pan retinal     photocoagulation (PRP) which can improve the visual prognosis in this complication     significantly. However , the treatment may also resulting adverse effects such as blurring of     central vision, visual field constriction and disturbance in dark adaptation and contrast     vision. Extended targeted retinal coagulation (TRP) to the ischemic areas may cause     regression of the neovascularization while minimizing some of the risks and complication     associated of treatment of PDR with these two methods.   "
156867|NCT01230476|"     Standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent     cisplatin. Addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma     cells with high EGFR protein expression, may enhance the effectiveness of radiation and     result in better tumour control. This study investigates the addition of 2 cycles of     cisplatin/5FU chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent     with radiation, for treatment of locally advanced nasopharyngeal carcinoma.   "
156721|NCT01232387|"     Objectives: 1) To determine risk factors for fetomaternal hemorrhage. 2) To identify a     cost-effective method to detect fetomaternal hemorrhage prior to significant fetal anemia.      Significance/Background: Fetomaternal hemorrhage (FMH) is a condition in which occurs when     the placenta transfers blood from the fetus to the mother. Normally, nutrition and gasses     pass from mother to baby through the placenta and only waste products pass from baby to     mother through the placenta. Whole blood cells do not normally cross the placenta in     significant amounts. Mild FMH, where a small amount of whole blood passes from fetus to     mother but does not hurt the mother or baby, occurs in about 75% of pregnancies. A pregnant     woman does not know this occurs. It is only discovered if a special blood test that is     labor-intensive to perform and difficult to interpret called the Kleihauer-Betke acid elution     test is done. As mild FMH hurts no one, this test is not part of routine care. In most cases,     testing is done only if a baby is born sick with unexplained anemia. Severe FMH, which can     cause the baby to become sick from anemia (low red blood cell count) is caused by large blood     loss into the mother, occurs in only 1-3 per 1000 births. Severe anemia caused by FMH can     result in death of the baby before or after birth, or significant illness in the newborn     period. Short term problems for the baby include difficulty breathing, difficulty maintaining     blood pressure, and difficulty providing oxygen to all parts of the body. This can cause     multiple problems with the function of internal organs including the liver, kidneys,     intestines, and brain. Babies who become sick from severe FMH can develop long-term problems     including cerebral palsy (a lifelong problem with body movements) and/or mental retardation.      It is not known why some pregnancies are affected by FMH and others are not. It is thought     that FMH may occur more frequently now than in the past, but no one knows why. If identified     early, FMH is readily treatable by blood transfusion of the baby before or after birth and/or     early delivery. Current laboratory testing for FMH is difficult and expensive. There is great     need identify high risk patients early in pregnancy in order to treat the condition before     the baby gets sick.      Approach: Five hundred women will be asked to participate in the study at the time they are     admitted to the Mount Sinai labor floor for delivery at term. After birth, newborns of study     mothers will be tested for anemia. Mothers of anemic babies will donate blood for     confirmation of FMH by established laboratory methods as well as for development of a new     laboratory screening protocol. All mothers will provide medical, social, environmental, and     full pregnancy history. Risk factors for FMH will be identified by statistical analysis of     this information.   "
156722|NCT01232374|"     Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor     (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different     indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck     (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phase I     study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in     patients with local advanced esophageal squamous cell carcinoma (LAFSCC) has shown the safety     and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase II trial     designed to assess the efficacy of the combination of Nimotuzumab administered concurrently     with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect     and toxicity.   "
156723|NCT01232361|"     The main purpose of this study is to find out how stimulant medications (methylphenidate or     amphetamine/ dextroamphetamine) for the treatment of Attention Deficit Hyperactivity Disorder     (ADHD)are processed in HIV-1 infected and HIV-uninfected children and adolescents.   "
156724|NCT01232348|"     The purpose of this study is to confirm the safety (ADR related to beta stimulant drugs,     unexpected ADRs) and efficacy of Symbicort in daily practice and the control status on     bronchial asthma and Patient satisfaction   "
156725|NCT01232335|"     The purpose of this study is to confirm the safety profile for long term treatment and     maximize doses and the control status on bronchial asthma in daily clinical usage   "
156726|NCT01232322|"     The purpose of this study is to investigate the safety and efficacy for long term treatment     of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical     usage.   "
156727|NCT01232309|"     Cardiovascular diseases (CVDs), especially atherosclerotic coronary heart disease and stroke,     are the leading causes of death globally. Important risk factors for CVDs include elevated     serum levels of total cholesterol, low-density lipoprotein(LDL)-cholesterol, triglycerides,     and low high-density lipoprotein (HDL)-cholesterol. Elevated oxidized LDL, a     pro-inflammatory villain, has also emerged as an important risk factor for the development of     CVDs. There is a growing need to identify safe and effective nutritional interventions that     offer a clinical benefit aimed at reducing one more of the risk factors for CVDs. Data from     many studies in humans have shown various health benefits provided by dietary fiber intake,     including an inverse association with the risk of developing cardiovascular disease. The     primary purpose of this study is to determine whether daily consumption for 6 weeks of     chitin-glucan, a fiber purified from a microorganism, is effective at reducing the amount of     oxidized LDL in humans with borderline-to-high LDL-cholesterol. The effects of chitin-glucan     on other cardiovascular risk factors will also be evaluated.   "
156728|NCT01232296|"     The purpose of this open-label, randomized, phase II study is to compare the safety and     efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with     advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the     Asia-Pacific region.   "
156729|NCT01232283|"     This study will evaluate the effects of an experimental (being tested) study drug called     apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and     therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast     and compare its effects to placebo (an inactive substance which contains no medicine but is     in the same form as the drug). This study will test efficacy (improvement of signs and     symptoms) and safety of apremilast in patients with moderate to severe psoriasis.   "
156730|NCT01232270|"     Since intrathecal fentanyl is known to sedation effect, intrathecal fentanyl will result in     lowering propofol requirement for conscious sedation under spinal anesthesia.   "
156731|NCT01232257|"     Cardiovascular morbidity and mortality is high in CKD patients. Nitric oxide (NO) deficiency     plays a crucial role in progression of CKD. This leads to endothelial dysfunction,     hypertension, and inflammation. Hydrogen sulfide (H2S) could serve as a backup mechanism for     NO deficiency in CKD. N-acetylcysteine (NAC) is a derivate of cysteine and this is the main     substrate for H2S production. Therefore, NAC should enable us to stimulate H2S production in     humans. Our objective is to investigate the effect of NAC on plasma H2S levels and on markers     of oxidative stress, inflammation, and endothelial dysfunction in healthy volunteers, CKD     patients, and dialysis patients. We hypothesize that there is an increase in H2S levels after     treatment with NAC.   "
156732|NCT01232244|"     Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in     response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon     are all known to regulate parameters such as appetite, food intake and induce weight loss.      Therefore we want to investigate mechanistic relations between the three hormones.   "
156751|NCT01231997|"     This study is designed to assess the effect of renal impairment on the pharmacokinetics,     safety and tolerability of udenafil in subjects with renal impairment compared to healthy     subjects.   "
156738|NCT01232166|"     Background: Endotracheal intubation has become a well established standard in protecting the     airway during surgical procedures, and in emergency situations. Serious complications can     occur from the incorrect placement of an endotracheal tube in a mainstem bronchus. If     unrecognized it can lead to hypoxemia secondary to atelectasis of the unventilated lung and     hyperinflation of the intubated lung, which can result in barotrauma. As bedside method the     golden standard to verify the correct endotracheal tube placement is bilateral ausculation of     the chest. However this is not always satisfactory, as breath sounds can be transmitted to     the opposite side of the chest in spite of endobronchial intubation. Therefore other clinical     tests to verify the correct endotracheal tube placement have become part of daily clinical     practice, like observation of symmetric chest movements, and use of the cm markings printed     on the endotracheal tube. However so far no study investigated which of these bedside     clinical methods works best in detecting an inadvertently placed endobronchial tube in     adults. We therefore designed a study to compare three different bedside methods to verify     endotracheal or endobronchial tube placement.      Objective: To determine which of four commonly used bedside methods of detecting inadvertent     endobronchial intubation in adults has the highest sensitivity and specificity.      Design: Prospective randomized, blinded study. Setting: Tertiary, academic hospital,     department of anaesthesia. Participants: 160 consecutive ASA I or II patients, aged 19-75     years, scheduled for elective gynaecological or urological surgery.      Interventions: Patients were randomly assigned to eight study groups. In four groups, an     endotracheal tube (ETT) was fiberoptically positioned 2.5-4.0 cm above the carina, whereas in     the other four groups the tube was positioned in the right mainstem bronchus. The four groups     differed in the bedside test used to verify the position of the endotracheal tube. First-year     residents and experienced anaesthesiologists independently performed one of the following     randomly assigned bedside tests in each patient in an effort to determine whether the tube     was properly positioned in the trachea: 1) bilateral auscultation of the chest     (Auscultation); 2) observation and palpation of symmetric chest movements (Observation); 3)     estimating the position of the ETT by the insertion depth (Tube Depth); and, 4) a combination     of all three mentioned tests (All Three).      Main outcome measures: Correct and incorrect judgements of endotracheal tube (ETT) position     as independently assessed by first-year anaesthesia residents and experienced     anaesthesiologists with each of the four bedside tests.   "
156739|NCT01232153|"     Recent studies reports feasibility, effectiveness and even less complications of using NIV     for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has     been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate     same results or even more in that conditions.   "
156740|NCT01232140|"     Rationale: Acute exacerbations are key events in chronic obstructive pulmonary disease     (COPD), resulting in poorer quality of life. Causes include irritants, viruses and bacterial     pathogens. These exacerbations are often treated with a combination of corticosteroids,     bronchodilators and antibiotics, but the benefit of antibiotic therapy remains controversial.     Several trials studying antibiotic treatment in AECOPD showed conflicting data, with several     large studies failing to demonstrate superiority of antibiotic therapy over placebo. Other     trials indicated that antibiotic therapy is effective in patients who have at least two of     the following symptoms: increased dyspnoea, increased sputum volume and increased sputum     purulence. Ever since sputum purulence has been used as a predictive marker in AECOPD, a     strategy that has been integrated in the GOLD guideline for treatment of AECOPD. However, the     color of sputum reported by patients is not always reliable and inspection of sputum is not     always possible. Several serum biomarkers such as C-reactive protein (CRP) and procalcitonin     (PCT) are now available. In a recent trial of doxycycline in addition to systemic     corticosteroids for patients hospitalized with AECOPD we found that CRP might be valuable as     a marker predictive of response to antibiotic treatment in AECOPD.   "
156741|NCT01232127|"     The purpose of this study is to assess the effects of famotidine, given twice daily, on     atazanavir administered with ritonavir and tenofovir in HIV-infected participants.   "
156742|NCT01232114|"     Functional dyspepsia (FD) is a common functional gastrointestinal disorder and is steadily     becoming a public health problem.Simotang is a classical formula that has been used to treat     gastrointestinal disorders for hundreds of years [9] and was approved as an oral liquid drug     by the Chinese National Food and Drug Administration in the 1980s.In this study,patients with     functional dyspepsia were divided according to the inclusive criteria into treatment group     and control group randomly, who were given Simo decoction or Domperidone tablets for 14     days。And then the gastric emptying, Symptoms in plasma were observed before and after     treatment in mult-center.   "
156743|NCT01232101|"     The study is investigator initiated. Tumors that gives the narrowing of the bile ducts     prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk     of bacterial growth in bile with severe infections as a result. Unresectable bile duct     strictures have routinely been treated them with plastic stents. The plastic stents have been     replaced by self expandable metallic stents.      These stents remain open longer for reasons that they have a larger diameter so that the bile     flows through more easily. One problem with these stents, however, is that the tumor growing     through the wire mesh which forms the wall of the stent. This has led to the development of     so-called covered stents. Whether covered stents have longer patency is unclear as well as     whether they are as safe. There is reason to believe that covered stents remain open longer,     but there may be an increased risk of migration and other complications.      The purpose is to prospectively and randomized compare the two stent types. The study     endpoint is the clogging of the stent or the patient's death. We also monitor complications,     regress time of the jaundice and success rate of stent placement   "
156744|NCT01232088|"     Medication errors are common in intensive care (Valentin A et al., BMJ. 2009;338).     Standardized color coded labels for user applied syringes enjoy strong support from many     health professionals, thinking that this might increase patient safety. Whether this is true     or not warrants further research.   "
156745|NCT01232075|"     The aim of this randomized controlled trial is to compare the efficacy of extended letrozole     regimen (2.5mg/day from cycle day 1 to 9) with clomiphene citrate (100 mg/day from cycle day     3 to 7) in women with unexplained infertility undergoing superovulation and intrauterine     insemination .   "
156746|NCT01232062|"     To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with     adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative     metastatic breast cancer patients   "
156747|NCT01232049|"     This study is designed to evaluate a pharmacokinetic drug interaction and safety between     Pitavastatin and Valsartan in healthy male subjects   "
156748|NCT01232036|"     This study is designed to to compare the pharmacokinetic and pharmacodynamic characteristics     and safety after oral administration of Glucophage with those after oral administration of     HL-018 in healthy male volunteers   "
156749|NCT01232023|"     This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of     indobufen in healthy subjects.   "
156750|NCT01232010|"     This study is designed to investigate the effect of renal impairment on the safety and     pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.   "
156752|NCT01231984|"     Anxiety about needles is a concern commonly expressed by diabetics when beginning insulin     therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy     profile of longer pen needles may appeal to many diabetic patients as the shorter needle may     be perceived as less intimidating and more comfortable. While pen needles of 4 to 8 mm in     length are generally used for insulin injection in patients considered thin or normal weight,     longer (12.7 mm) needles are still often prescribed for overweight or obese patients with     diabetes. Since skin thickness is nearly constant across a range of body mass index (BMI), a     clear rationale exists for the use of shorter needles in obese patients. (Gibney et al., CMRO     2010)      The primary purpose of this study is to evaluate whether the BD Ultra-Fine™ Nano 4mm x 32     Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent     glucose control (as measured by hemoglobin A1c levels) as the BD Ultra-Fine™ 8mm x 31G and     the BD Ultra-Fine™ 12.7mm x 29G pen needles in obese subjects with diabetes.   "
156753|NCT01231971|"     The purpose of this study is to build upon the information obtained in the original     Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study     funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how     brain imaging technology can be used with other tests to measure the progression of mild     cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the     neuroscience of AD. This information will aid in the early detection of AD, and in measuring     the effectiveness of treatments in future clinical trials.   "
156754|NCT01231958|"     The investigators long-term goal is to understand the complex interactions of diet and other     behavioral and environmental factors, genetics, and psychosocial stress on the high and     apparently increasing prevalence of cardiovascular disease (CVD) risk factors in Puerto Rican     adults.   "
156755|NCT01231945|"     Background:      - Low-cost molecular human papillomavirus (HPV) testing may offer a more robust alternative     to Pap smears and visual inspection for cervical cancer screening of underserved women. Two     low-cost molecular tests for human HPV, the HPV E6 Test and the careHPV test, have been     developed to detect cervical cancer by testing for HPV DNA. These tests take between 2 and 3     hours to run and may provide point-of-care (diagnostic testing at or near the site of patient     care) testing for HPV. Researchers are interested in evaluating both tests to determine the     best strategy for HPV testing of women who live in rural or underserved areas that have a     high prevalence of cervical cancer diagnoses.      Objectives:        -  To evaluate the clinical performance of the HPV E6 Test and careHPV in detecting          cervical cancer and precancerous lesions.        -  To evaluate the best low-cost test or combination of tests for women who have been          referred for cervical cancer screening or treatment.        -  To compare the clinical performance of self-collected specimens versus          clinician-collected specimens in detecting cervical cancer and precancerous lesions.      Eligibility:      - Women between 25 and 65 years of age who live in rural China.      Design:        -  This study involves an initial testing visit and a 1-year followup visit for a high-risk          subgroup.        -  Participants will have the HPV E6 test, careHPV, and a visual inspection test for          cervical cancer. For comparison, participants will also have the standard HPV test          approved by the U.S. Food and Drug Administration.        -  Participants who test positive for HPV on any of the above tests will also have          colposcopy to collect samples of cervical tissue for further study.        -  A random sample of women who test negative for HPV will also have colposcopy.          Participants may also have biopsies if there is visual evidence of cervical          abnormalities.        -  At the 1-year followup visit, participants in the high-risk subgroup will have the same          tests as in the previous visit..   "
156756|NCT01231932|"     Background:      - Fatigue, a common side effect of cancer and its treatment, is found in up to 96% of cancer     patients. Fatigue is difficult to treat because its cause is poorly understood. Research has     indicated that cancer-related fatigue may be caused by a number of factors, including immune     system responses to cancer treatment. Researchers are interested in studying individuals who     are receiving cancer treatment in order to better understand the causes of fatigue.      Objectives:      - To study fatigue in individuals who are receiving cancer treatment.      Eligibility:      - Individuals at least 18 years of age who have localized cancer that has not spread and are     scheduled to start cancer treatment at the National Institutes of Health.      Design:        -  This study involves an initial screening visit and a minimum of three outpatient visits.        -  Participants will be screened with a medical history, and blood tests.        -  Participants who are scheduled to have cycles of cancer treatment will be seen once          before the start of each cycle, once at the midpoint of each cycle, and once at the end          of each cycle. Participants whose treatment does not follow a cycle will be seen before          the start of treatment; 2 weeks after starting treatment; and 1 month, 3 months, 6          months, and 1 year after starting treatment, for a total of six outpatient visits.        -  At each study visit, participants will complete the following tasks:        -  Questionnaires about physical activity, fatigue, depression, and quality of life.        -  Computerized cognitive tests of memory, attention, and ability to follow directions. The          tests are timed to determine whether these brain functions are affected by cancer          treatment and whether they occur with fatigue symptoms.        -  Blood samples to monitor immune system and other responses to treatment.        -  Hand grip strength test to evaluate physical strength.        -  Physical activity monitor and journals to study how fatigue affects physical activity.        -  Participants who need additional cycles of cancer treatment will continue to have visits          until the end of the third cycle, for a maximum of nine outpatient visits.        -  Treatment will not be provided under this study.   "
156757|NCT01231919|"     This phase I trial is studying the side effects, best way to give, and best dose of Akt     inhibitor MK2206 (MK2206) in treating patients with recurrent or refractory solid tumors or     leukemia. MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth.   "
156758|NCT01231906|"     This randomized phase III trial studies combination chemotherapy to see how well it works     compared to combination chemotherapy with topotecan hydrochloride in treating patients with     non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine     sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving more than one drug (combination     chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy     is more effective with topotecan hydrochloride in treating Ewing sarcoma.   "
156759|NCT01231893|"     The purpose of this experimental therapy is an assessment of the safety and feasibility of     transplantation of autologous olfactory ensheathing glia and olfactory fibroblasts obtained     from the olfactory mucosa in patients with complete spinal cord injury.   "
156760|NCT01231880|"     The investigators hypothesize that schoolchildren treated with IPT using DP over one year of     follow-up will have a different risk of clinical malaria compared to those treated with     placebo.   "
156784|NCT01231568|"     The study is designed to evaluate the effects of a high fat meal on the pharmacokinetics of     150 mg of GSK2118436, as well as the effects of particle size on the relative bioavailability     of GSK2118436.   "
156785|NCT01231555|"     This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects     consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg     once daily with a control arm of open-label efavirenz (EFV) 600 mg once daily. The background     ART for all 3 arms will be chosen by the Investigators and will be either abacavir/lamivudine     [ABC/3TC] or tenofovir/emtricitabine [TDF/FTC] fixed dose combination (FDC) tablets.     Antiviral activity, safety, PK, and development of viral resistance will be evaluated.   "
156868|NCT01230463|"     The primary aim of this study is to show the non-inferiority of 15 mg intraoperative dose of     ketorolac as compared to the standard 30 mg ketorolac by looking at the VAS scores 4 hours     after an adult spine surgery.   "
156761|NCT01231867|"     Patients who have experienced and survived non-ST segment elevation acute coronary syndromes     are often prescribed a combination of aspirin and clopidogrel to thin the blood and prevent     further acute coronary episodes. Both clopidogrel and aspirin may cause stomach bleeds and so     a prophylactic proton pump inhibitor is frequently co-prescribed in order to prevent such     bleeds. Recent mechanistic and observational studies suggest proton pump inhibitors may     reduce the effectiveness of clopidogrel and so patients may not benefit as much as expected     from combined aspirin and clopidogrel. The investigators propose a cohort study of patients     prescribed clopidogrel + aspirin. Amongst these patients the investigators will measure the     relative rate of acute coronary syndrome and death comparing patients with and without proton     pump inhibitor treatment. To provide a more complete picture of the risks and benefits of     treatment the investigators will also measure the relative rate of stomach bleeds in the same     groups of patients. In addition, whether the inhibitory effect of proton pump inhibitors on     the protective effect of clopidogrel is due to their inhibition of drug metabolising enzymes     will be explored by assessing the effects of other drugs that inhibit the same enzymes.   "
156762|NCT01231854|"     The purpose of this study is to investigate the comparative efficacy, safety and efficiency     of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis.   "
156763|NCT01231841|"     RATIONALE: Immunosuppressive therapies, such as anti-thymocyte globulin and cyclosporine, may     improve bone marrow function and increase blood cell counts. PURPOSE: This phase II trial is     studying how well giving anti-thymocyte globulin together with cyclosporine as first-line     therapy works in treating patients with severe aplastic anemia.   "
156764|NCT01231828|"     The project will improve scientific knowledge regarding a recent law applying potentially to     every french driver. It will give for the first time an indication on the impact of alerting     treatments on driving risks. It will reinforce the links between different research     environments (sleep physiopathology, clinical research, cognitive neurosciences, drivers     supervision, virtual reality, pharmacology) among the Réseau Eveil Sommeil Attention et     Transports (RESAT) network.   "
156765|NCT01231815|"     Heart transplantation is the ultimate therapeutic option in patients with end-stage heart     failure. Since advances in the treatment of acute rejection has increased early transplant     survival, cardiac allograft vasculopathy (CAV) is the main factor limiting long-term     survival. The prevalence of angiographically proven CAV is high, documented in 40-50% of     transplant recipients 5 years after transplantation. Therefore, annual coronary angiography     remains widely used to monitor transplanted patients, although pathologic studies and     intravascular ultrasonography have demonstrated that coronary angiography underestimates the     severity of CAV. Perfusion SPECT may underestimate allograft vasculopathy in case of diffuse     coronary lesions. In this setting, the assessment of coronary reserve by means of Positron     Emission Tomography (PET) and perfusion cardiac magnetic resonance imaging (CMR) have not     been investigated.   "
156766|NCT01231802|"     The purpose of the study is to determine if eniluracil/5-FU/leucovorin in metastatic breast     cancer (MBC) may have efficacy and tolerability advantages over capecitabine monotherapy.   "
156767|NCT01231789|"     The current study is designed to clarify the neuroprotective effect of remote ischemic     preconditioning on the patients underwent open-heart cardiac surgery.   "
156768|NCT01231776|"     Due to various causes, such as brain impairment, environment changes, anxious,et al.     patients, who undergo cardiopulmonary bypass, often suffer from poor quality of sleep. In     chinese traditional medicine, acupuncture can improve the quality of sleep in patients with     sleeping disorder. But it remains acupuncture could improve the quality of sleep in patients     with heart operations.   "
156769|NCT01231763|"     This study is being done to find out what women would want in a film vaginal product for     human immunodeficiency virus (HIV) prevention, especially what it should look like and how to     apply it.      The investigators hypothesize that women will prefer a smooth, clear, and rectangular     quick-dissolve vaginal film for HIV prevention over a textured, opaque, square quick-dissolve     vaginal film.   "
156770|NCT01231750|"     The purpose of this study is to test the hypothesis that application of topical capsaicin in     patients with stable angina will result in improved exercise tolerance and reduced cardiac     ischemia.   "
156771|NCT01231737|"     Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract     infections risked recurrent infection. Urinary tract infection causes marked discomfort for     the patient, has a negative impact upon quality of life, and is associated with high social     and health costs in terms of specialist appointments, laboratory and instrumental tests and     prescriptions . Although diverse cycles of antibiotic therapy and prophylaxis have been     proposed, doubts persist about the most efficacious pharmacological agents, duration of     prophylaxis , the incidence of adverse effects and relapse when antibiotic therapy is     suspended.      Aims of the study:        1. To compare the efficacy of two prophylactic schedules (Prulifloxacin vs Phosphomycin):             -  in reducing the number of urinary tract infection episodes during prophylaxis             -  in reducing the number of urinary tract infection episodes after prophylaxis             -  in improving the patient's quality of life .        2. To assess :             -  Tolerability of antibiotic prophylaxis             -  The incidence of resistance to antibiotic therapy   "
156772|NCT01231724|"     The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is     safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).   "
156786|NCT01231542|"     This study will be a phase I, open label, two arm, fixed sequence crossover study to     investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of     GSK1349572 and the safety and tolerability of GSK1349572 and rifamycin co-administration.     Subjects enrolled in Arm 1 will receive GSK1349572 50 mg once daily for 7 days, GSK1348572 50     mg twice daily for 7 days, and GSK1349572 50 mg twice daily in combination with rifampin 600     mg once daily for 14 days. Subjects in Arm 2 will receive GSK1349572 50 mg once daily for 7     days and GSK1349572 50 mg once daily in combination with rifabutin 300 mg once daily for 14     days. Serial PK sampling will be completed following the last dose of each treatment. Safety     and tolerability will be assessed throughout the study through assessment of adverse events     (AEs), and clinical laboratory tests.      This study will be conducted at one center in the US with healthy adult male and female     subjects.   "
156773|NCT01231711|"     Background: Current military involvement in Afghanistan (Operation Enduring Freedom - OEF)     and Iraq (Operation Iraqi Freedom - OIF) has created unforeseen burdens on the mental health     and well-being of US service women and men. Although OEF/OIF service members and veterans are     at high risk of developing sub-threshold combat stress and depressive symptoms or full     disorders in the post-deployment period, only a small fraction ever receive care. The VETS     PREVAIL Intervention, which combines Cognitive-Behavioral-Therapy-based (CBT-based) coping     skills training with peer-to-peer support and counseling, was specifically designed to offer     the returning OEF/OIF service member or veteran an accessible and confidential first step to     care.      Evaluation Study: RISE Consulting, lead by Dr. Benjamin W. Van Voorhees, MD, MPH, was     contracted to supervise a pilot study of potential benefit, feasibility and safety of the     VETS PREVAIL Intervention. The study would consist of a single group pre/post comparison     study of N=50 recent OEF/OIF veterans in the frame work of a phase 1 clinical trial (phase     1). Feasibility (adherence and satisfaction), evidence of clinical benefit would be evaluated     through changes in the following clinical self-report measures: i) symptoms of depressed mood     (Center for Epidemiologic Studies Depression Scale, CES-D), ii) post traumatic stress     disorder (Post Traumatic Stress Disorder Checklist-Military, PCL-M), and iii) functional     status (Short Form 12, SF-12), as well as changes in key attitudes toward mental health care     seeking (intent to seek treatment, mental health self-efficacy and stigma).   "
156774|NCT01231698|"     The purpose of this study is investigate the effects on systemic hemodynamics and organ     function of esmolol when used to maintain heart rate below a predefined threshold in patients     with septic shock.   "
156775|NCT01231685|"     HIV infection exerts a negative impact on the course of HCV infection. Co-infected     individuals progress more rapidly to liver fibrosis, cirrhosis and ESLD compared to those     infected with HCV alone. Some of the this accelerated fibrosis may be related to longterm     chronic toxicity from protease inhibitor based ART.      Hypothesis: Switching from ritonavir boosted-PI based ART regimen to a Raltegravir-based     regimen will reduce the rate of hepatic fibrosis progression in HIV-HCV co-infected patients     as measured by transient elastography (Fibroscan®) and the AST-to-platelet ratio index     (APRI).   "
156776|NCT01231672|"     A prognostic score was proposed by the investigative team to predict death at 1 month. This     score is based on certain biological markers, scored under emergency conditions in the first     24 hours of routine clinical practice management for septic shock.      The main objective of this multicenter study is to validate the performance of the score in     terms of area under the ROC curve and negative predictive value.   "
156777|NCT01231659|"     This is a multi-center, Israeli phase II open label study evaluating treatment with RAD001     (10 mg daily) combined with letrozole (2.5 mg daily) in postmenopausal women after recurrence     or progression on Tamoxifen, Anastrozole or Examestane.      There are no treatments specifically approved after recurrence or progression on AIs.     Available options, based on common clinical practice and several treatment guidelines (e.g.     NCCN treatment guidelines 2008), include fulvestrant.      Combining RAD001 with letrazole is a rational approach to the treatment of advanced Brest     Cancer, offering the potential for inhibition of tumor cell growth\ proliferation and anti     angiogenesis while at the same time potentially preventing the development of letrazole     resistance.   "
156778|NCT01231646|"     Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth     to infant with certain birth defects. However, some medications may affect the action of     folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how     folate works in our body.   "
156779|NCT01231633|"     The purpose of this study is to compare visual improvement and total number of intraocular     injections in eyes with macular edema following central retinal vein occlusion (CRVO)after     initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).   "
156780|NCT01231620|"     The purpose of this study is to test the safety and efficacy of zanamivir given intravenously     and how well it works at two different doses in hospitalized adolescents and adults with flu.     Zanamivir will be compared with oseltamivir, which is used for treating flu.   "
156781|NCT01231607|"     The purpose of this six month study is to show that dutasteride is safe and more effective     than placebo, and at least as safe and effective as finasteride in treating hair loss in men     with androgenetic alopecia. Three doses of dutasteride will be investigated.   "
156782|NCT01231594|"     This rollover study is designed to provide continued access to GSK2118436 for eligible     subjects with BRAF mutation-positive tumors who have previously participated in a     GlaxoSmithKline (GSK)-sponsored GSK2118436 study (parent study), who have no evidence of     progressive disease and who have tolerated GSK2118436 in the parent study without significant     toxicities. Subjects will be enrolled into the appropriate cohort based upon the treatment     received in their parent study. Safety assessments (physical examinations, vital signs,     12-lead electrocardiograms, echocardiograms, clinical laboratory assessments, and monitoring     of adverse events) will be made throughout the study. Clinical activity will be assessed     using local standard of care imaging practices and the appropriate response criteria as     determined by the investigator.   "
156783|NCT01231581|"     GSK1120212 is a potent and highly selective inhibitor of MEK phosphorylation and kinase     activity and has demonstrated potent anti-proliferative activity against human pancreatic     cancer cell lines. This study is a Phase II, randomized placebo-controlled trial of the MEK     inhibitor GSK1120212 plus gemcitabine vs. placebo plus gemcitabine in subjects with     metastatic pancreatic cancer. Eligible subjects will receive intravenous gemcitabine with     oral GSK1120212 or placebo. Therapy will continue until treatment discontinuation criteria     are met. The primary objective will be to compare the overall survival of subjects in the     GSK1120212 plus gemcitabine arm vs. subjects in the placebo plus gemcitabine arm. Secondary     objectives include comparison of progression free survival, overall response rate, and     duration of response between the two arms. Exploratory research objectives include the     evaluation of population pharmacokinetics as well as blood and tissue based biomarkers.     Safety will also be monitored throughout dosing.      Once the determined number of survival events has occurred, if subjects are eligible, they     will have the option to enter MEK114375, an open-label, Phase Ib rollover study of GSK1120212     monotherapy or GSK1120212 in combination with other anti-cancer treatments.   "
181612|NCT00221793|"     The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and     to study its link with an energetic balance change.   "
156787|NCT01231529|"     GSK1349572 is an integrase inhibitor that is currently in clinical development for the     treatment of human immunodeficiency virus (HIV) infection. GSK1349572 is metabolized     primarily by uridine diphosphate glucuronosyltransferase (UGT)1A1 with a minor role of     Cytochrome P450 (CYP)3A. Hepatic impairment could potentially alter the clearance and plasma     protein binding of GSK1349572. This study will evaluate the single dose pharmacokinetics and     safety of GSK1349572 in healthy subjects and in subjects with mild or moderate hepatic     impairment based on Child-Pugh category.      This is a single-dose, open-label, parallel group, two-part, adaptive study in adult males     and females with mild or moderate hepatic impairment and matched, healthy control subjects     with normal hepatic function. Healthy control subjects (16) will be matched for gender, age,     and BMI to the subjects in the mild (8) or moderate (8) hepatic impairment category. In Part     1, approximately 8 subjects with moderate hepatic impairment (cohort 1) and 8 matched,     control subjects (cohort 2) will each receive GSK1349572 50 mg as a single dose in the fasted     state followed by pharmacokinetic sampling for total concentrations of GSK1349572 in plasma.     Free (unbound) plasma concentrations of GSK1349572 will also be evaluated at sparse, selected     time points. If the geometric mean total plasma area under the concentration curve (AUC) of     GSK1349572 is increased by > 2-fold in moderately impaired subjects compared to matched     controls, Part 2 will be conducted to evaluate GSK1349572 pharmacokinetics in another group     of subjects with mild impairment (8, cohort 3) and matched, control subjects (8, cohort 4).     Vital signs, electrocardiograms (ECGs), and adverse events will be monitored throughout the     study. A follow-up visit will occur 7-10 days after the dose of study drug.   "
156788|NCT01231516|"     ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel     group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected     antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to     receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an     investigator selected background regimen consisting of at least one fully active agent plus     no more than one second single agent which may or may not be active. Antiviral activity,     safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.   "
156789|NCT01231503|"     The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an     efficacious malaria vaccine that is deliverable through the existing system, the Expanded     Program on Immunization (EPI) of WHO. This study has been designed to:        -  Investigate the safety and immunogenicity of 7 infant immunization schedules of the          experimental malaria vaccine integrated with an EPI regimen.        -  Investigate how to maximize the antibody response to the experimental malaria vaccine.   "
156790|NCT01231490|"     This is a methodological study designed to investigate a new model for testing pain agents in     the treatment of patients with osteoarthritis (OA). This will be a double-blind, randomised,     placebo controlled three-way cross-over study in patients with OA of the knee.   "
156791|NCT01231477|"     The aim of the present study was to evaluate the effects of anaesthesia with sevoflurane and     surgery on cytokines response.   "
156792|NCT01231464|"     The objective of this study is to compare the efficacy and safety of Fluticasone Furoate     Nasal Spray (FFNS), that is FFNS with placebo in Chinese adult and adolescent subjects with     Allergic Rhinitis as AR. There are 3 phases, 2 to14 day run in, 2 week treatment, and 3 to 5     day follow up. After run in period, at least 360 subjects with AR ( ages of 12yrs and 65yrs,     inclusive) will be randomised to receive FFNS 110ug once daily or placebo for 2 weeks. The     primary endpoint is the change from baseline of reflective total nasal symptom score (rTNSS)     during treatment period, and the secondary endpoints include mean change from baseline in     nasal finding scores by rhinoscopy at completion of study treatment, and severity of overall     inference in activities of daily living. Safety measures include AE (Adverse Event) reports,     ECGs (Electrocardiograph), physical exams, vital signs, and nasal exam. In addition,     reflective total ocular symptom score (rTOSS) will be measured as an explorative endpoint,     only in the specific AR (Allergic Rhinitis) patients with severe ocular symptoms.   "
156793|NCT01231451|"     DMPA (depot medroxyprogesterone acetate or the 'depot' injection) is a widely used     contraception. It is popular in woman with HIV as it probably still works when you take HIV     drugs. HIV drugs can increase or decrease the level of other drugs (e.g. contraceptives) in     your bloodstream which may make them work less well or increase side effects. It is assumed     that DMPA can be given with HIV drugs there are no studies proving this.      The purpose of the study is to investigate whether an HIV drug combination containing     lopinavir/ritonavir affects DMPA when they are taken at the same time.   "
156794|NCT01231438|"     Patients with reduced renal function normally develop hyperparathyroidism, which in turn is     associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may     be enhanced by an increased level of FGF23 which is often seen in the early stage of renal     failure. This pilot study will investigate the FGF23-lowering effect of early initiation of     treatment with a phosphate binder versus active vitamin D in an open crossover design.   "
156795|NCT01231425|"     The purpose of this study is to evaluate prospectively the effectiveness of acupuncture as     adjunctive therapy in the treatment of spinal pain is the three backbone areas: cervical,     thoracic and lumbar pain, under conditions of usual clinical practice as the medical     acupuncturist performed acupuncture, with and without supplementary pharmacological treatment     during the first 4 weeks of follow up.   "
156796|NCT01231412|"     This randomized phase III trial studies how well graft-vs-host disease (GVHD) prophylaxis     works in treating patients with hematologic malignancies undergoing unrelated donor     peripheral blood stem cell transplant. Giving chemotherapy and total-body irradiation before     a donor peripheral blood stem cell transplant (PBSCT) helps stop the growth of cancer cells.     It may also stop the patient's immune system from rejecting the donor's stem cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving total-body irradiation (TBI) together with fludarabine phosphate (FLU), cyclosporine     (CSP), mycophenolate mofetil (MMF), or sirolimus before transplant may stop this from     happening.   "
159398|NCT01197235|"     The purpose of this study is to determine whether the drug that produce red blood cells is     effective in the prevention of kidney dysfunction after coronary angiography in patients with     chronic kidney disease.   "
156798|NCT01231386|"     MicroRNAs (MiRNAs) regulate the translation of RNAs and are implicated in cell proliferation     and renewal both under physiologically normal as well as in malignant conditions.     Dysregulation of specific miRNAs may be associated with either gaining oncogenic or loosing     tumor suppressing functions. MiRNA dysregulation has been implicated in breast cancer     tumorigenic (stem cell) and non-tumorigenic development. Therefore, miRNA profiling of     treatment naïve and treatment-exposed breast tumors and sequential samples of blood/serum     will allow for identification of miRNA markers of prognosis and as indicators and potential     targets for personalized therapies. In this proposal, specimens from patients treated in the     clinical breast cancer program on already existing protocols (IRB 05091 and 05015) will be     characterized by Dr. Rossi's laboratory and collaborators, and the information gained will be     applied to develop specific therapies.   "
156799|NCT01231373|"     Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and     may cause discomfort. In this study, patients with varicose veins in the legs will be     participating. The purpose of this research study is to evaluate the safety and effectiveness     of three different concentrations of an investigational drug, Polidocanol Endovenous     Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and     appearance of varicose veins.   "
156800|NCT01231360|"     Specific Aim 1: To test the hypothesis that subjects with PAD and intermittent claudication     have altered expression of genes that regulate skeletal muscle metabolism.      Specific Aim 2: To test the hypothesis that exercise training improves calf skeletal muscle     insulin resistance and genes that regulate skeletal muscle metabolic function in PAD patients     with intermittent claudication.   "
156801|NCT01231347|"     AMG 479 is an investigational fully human monoclonal antibody that targets type 1     insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important     role in the regulation of cell growth and survival.      Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is     administered on days 1 and 15 of the 28 day cycle, both are administered intravenously.      The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall     survival as compared to placebo and gemcitabine.   "
156802|NCT01231334|"     A study comparing the topical application of Aczone® plus Differin® versus Duac® plus     Differin® in patients with severe facial acne (facial acne vulgaris).   "
156803|NCT01231321|"     A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5     sites in Russia. Adalimumab was administered by subcutaneous injection every other week, with     dose escalation to weekly dosing available for participants not receiving concomitant     disease-modifying antirheumatic drugs (DMARDs) who did not achieve American College of     Rheumatology 20 (ACR20) criteria after 12 weeks of treatment. Efficacy and safety     measurements were performed throughout the study.   "
156804|NCT01231308|"     The study is aimed to compare: Laparoscopic Roux-en-Y-Gastric Bypass (RYGB) + optimal medical     therapy versus Intensive lifestyle modification and optimal medical therapy in the treatment     of type 2 diabetes in overweight-to-moderately obese patients (BMI: 28-34kg/m2; the lower BMI     cut-off will be 26kg/m2 in patients of Asian descent).      This is a single center, prospective randomized study. The study at the Weill College Medical     College Diabetes Surgery Center. This study is intended to be a pilot investigation whose     results can inform clinicians and researchers for future larger or multi-site trials of     diabetes surgery. This study will also be used for the definition of a core protocol for     independent randomized clinical trials to be carried out at various centers participating in     a multinational consortium.   "
156805|NCT01231295|"     The primary objective of this study is to characterize cerebral metabolism modifications     using 18F-FDG PET technology and perfusion with 99MTC-ECD SPECT in patients with prodromal     Alzheimer's Disease drawn from a high risk population. We also compare PET and SPECT imaging     within this framework, and search for optimal diagnostic thresholds.   "
156806|NCT01231282|"     Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique     that characterizes tissue by probing changes in water diffusion secondary to differences in     the tissue microstructure. These changes in water diffusion result in differences in signal     intensity on diffusion-weighted images that are quantified with the apparent diffusion     coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be     diminished, due to the increased number of cells. This will restrict water diffusion,     identified by increased signal intensity (SI) on native diffusion-weighted images and low     ADC. Contrary, in tissue with low cellularity, like benign lesions and treatment induced     necrosis, the EES will be enlarged due to the lower density of cells, or in case of necrosis,     the complete absence of cellular organization. This will facilitate water diffusion, leading     to absent SI on native diffusion-weighted images and high ADC.      The purpose of this study is to image anatomy and lymph nodes in healthy volunteers with     whole body diffusion-weighted imaging. This way maps of normal anatomy can be created on the     whole body diffusion-weighted images which can be used as a reference in further studies with     patients scanned with the same whole body diffusion-weighted imaging scan protocol.      A group of 30 healthy volunteers will receive a whole body diffusion-weighted imaging scan on     a 3 Tesla T-MRI system.      A total scan session will take about 30 minutes. Contrast administration is not required and     patients will not be exposed to radiation.   "
156849|NCT01230710|"     This open-label, single-arm study will evaluate the safety and efficacy of Tarceva     (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who     have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients     will receive Tarceva at a dose of 150 mg orally daily until disease progression or     unacceptable toxicity occurs.   "
181637|NCT00222118|"     Breastfeeding initiation and duration in adolescent mothers.   "
156852|NCT01230671|"     Breast Cancer is the most common cancer amongst Canadian women. Studies report that breast     cancer patients are the most likely to use complementary medicine within the oncologic     population. Yoga has become especially popular with this group as it promises to improve the     mind, body and soul holistically. The investigators yoga program specifically focuses on     rebuilding physical strength, increasing flexibility and reducing the pain and stress     associated with the post-operative period. This study will examine how yoga can help improve     the overall quality of life and its effects on the physical well-being of women with breast     cancer. With positive statistical results, the investigators hope to implement yoga as part     of their rehabilitation services at the Cedars Breast Clinic.   "
156807|NCT01231269|"     Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique     that characterizes tissue by probing changes in water diffusion secondary to differences in     the tissue microstructure. These changes in water diffusion result in differences in signal     intensity on diffusion-weighted-images that are quantified with the apparent diffusion     coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be     diminished, due to the increased number of cells. This will restrict water diffusion,     identified by increased signal intensity (SI) on native DWI images and low ADC. Several     studies indicate the value of DWI for differentiation of benign and malignant lymph nodes,     detection of tumor recurrence and for ADC-based prediction of treatment outcome in various     solid tumours (Koh DM et al, Am J Roentgenol 2007).      Patients with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cell     lymphoma, follicular lymphoma, mantle cell lymphoma and PTLD) will be included in the study.     These patients will receive a WB-DWI scan before treatment, once or twice during treatment     (depending on the type of lymphoma) and after the completion of the treatment. The MRI scan     will be performed on a 3 Tesla-MRI system without contrast administration and without     exposing the patient to radiation.      Whole body diffusion-weighted images will be prospectively interpreted by two experienced     radiologists, blinded to all clinical and imaging data. Findings will be correlated to     FDG-18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose , biopsies performed in clinical     routine (bone marrow always - soft tissue lesions if indicated) and imaging follow-up.      The purpose of this study is:        -  to evaluate Whole body diffusion-weighted imaging for staging of lymphoma        -  to evaluate Whole body diffusion-weighted imaging as an early predictive biomarker for          treatment outcome        -  to evaluate Whole body diffusion-weighted imaging for differentiating residual tumor          from post therapy changes   "
156808|NCT01231256|"     A new working method, i.e. a questionnaire completed at home followed by a patient-centred     preventive health consultation with follow-up, can be used by all general practitioners (GPs)     as a preventive offer to their patients with multiple problems in lifestyle, well-being or     health behaviour, if this project is shown to be effective.      The investigators use a broad preventive offer in a structured way to young adults with     multiple psychosocial problems (a certain risk profile) found by a screening questionnaire     when arriving to the clinic.      The main hypothesis of the project is:      By using the questionnaire and subsequent patient-centred health consultation the GP is able     to support the participants to improve their resources, their well-being and self-estimated     health. Subsequently, relevant changes in health habits and life situation might be initiated     in order to prevent or reduce future problems or illness.   "
156809|NCT01231243|"     There is a controversy in the dentistry literature about how the use of associated light to     activate 35% hydrogen peroxide gel during in-office tooth bleaching may increase the     bleaching effectiveness. The studies that demonstrated an increased level of bleaching using     light activation employed lower hydrogen peroxide gels while the ones reporting no     statistical difference employed higher hydrogen peroxide gels.      The hypothesis of this study is that the effectiveness of light activation tooth bleaching in     dependent on the hydrogen peroxide concentration employed.   "
156810|NCT01231230|"     The addition of an inhaled long-acting beta-adrenergic agonist to an inhaled     glucocorticosteroid improves disease control in persistent asthma. This observation has     supported the use of long-acting beta-adrenergic agonist/glucocorticosteroid combination     preparations for the management of asthma. Currently, salmeterol/fluticasone and     formoterol/budesonide are available for clinical use. The long-term beneficial clinical     effects of the two drug classes seem to be synergistic, and several mechanisms of     glucocorticoid-beta-adrenergic agonist interactions involving gene transcription have been     invoked to explain this phenomenon.This study, wish to address the question whether     glucocorticoids can acutely potentiate the bronchodilator response to a long-acting     beta-adrenergic agonist.We expect that in patients with asthma, the short-term bronchodilator     effect of salmeterol is enhanced by the addition of fluticasone, which by itself has no     short-term bronchodilator effect. To test this premise, we will assess the respective     short-term effects of salmeterol (50 µg), fluticasone (250 µg), salmeterol/fluticasone     (50/250 µg), and placebo/placebo on spirometric parameters. Airway Blood flow will also be     measured to ensure that vasoconstriction does not occur.   "
156811|NCT01231217|"     The purpose of this study is to assess whether green tea or coffee influence the course and     life quality of patients with mild to moderately active Crohn's disease.   "
156812|NCT01231204|"     Research study to determine if putting local anesthetic—or numbing medication—through a tiny     tube placed next to the nerves that go to a breast prior to and following a mastectomy will     decrease subsequent pain.   "
156813|NCT01231191|"     This is a research study to determine if giving acetaminophen intravenously in hte operating     room will decrease the number of patients who require additional pain medicine, such as     morphine, after surgery in the recovery room.   "
156814|NCT01231178|"     The project aims to examine the efficacy of a 12-week intake of alginate based ready to drink     supplement on development in body weight and body composition, and risk markers for type-2     diabetes and cardiovascular disease in obese subjects.   "
156815|NCT01231165|"     Treatment of coronary artery disease is a major health care problem across the entire word,     and the United States. Unfortunately, despite a number of medical advances, diagnostic     procedure, or epidemiological studies, the treatment of these patients remain complex, and     and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United     States and Canada documented that drug treatment, coronary interventions or both were not     effective solution in coronary artery diseases.      A novel approach has recently been developed, based on the critical role of the potassium (K)     content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by hemoglobin     (red-blood-cell) occurs simultaneously in blood passing through the lungs, whereas in the     organs as the heart, the hemoglobin release both Oxygen and K ions.      This apparently simple mechanisms occurs in human blood in all individuals but could be     altered in subjects with acquired or hereditable defect in red-blood-cell K content. The     purpose of this trial, thus, will be to evaluate the pharmacological effects of Amiloride on     RBC K-uptake and transport and its impact on reversion of angina, electrocardiographic     changes of myocardial ischemia and electrical regeneration of the heart in subjects with     coronary artery diseases.   "
156816|NCT01231152|"     The aim of the study is to investigate the association of obesity with arterial blood     pressure, atherosclerosis, target organ damage (heart, arteries, kidney) and insulin     resistance in children and young adolescents.   "
156817|NCT01231139|"     This primary aim is to investigate the effect of paracetamol in reducing body temperature in     patients who have sustained traumatic brain injury. This study is also investigating the     safety of paracetamol in this patient population.   "
156818|NCT01231126|"     The purpose of this study is to evaluate the blood loss in induced vaginal delivery by     misoprostol and caesarians section with induction attempt.   "
156819|NCT01231113|"     Malaria in pregnancy poses enormous public health challenges, contributing to significant     maternal and infant deaths yearly. Adverse outcomes include maternal anaemia and low     birthweight. Down regulation of cellular immunity increases pregnant women's susceptibility     to malaria and mediate these adverse outcomes.      The World Health Organization recommends treatment with artemisinin-combination therapy.     Ghana uses quinine for malaria in first trimester pregnancies while artesunate-amodiaquine     (AS-AQ) and quinine again are used in later trimesters. Recent amendments added     artesunate-lumefantrine and dihydroartemisinin-piperaquine (DHA-PPQ) to the antimalarials     used in the country. A high degree of safety and efficacy of DHA-PPQ is documented in several     studies. DHA-PPQ, though not specified for use in pregnancy as of now, is accessible and     available following its inclusion in the national malaria guidelines and may inadvertently be     used to treat malaria in pregnancy. Paucity of data on DHA-PPQ use in pregnancy makes it     pertinent to study its safety, tolerability and efficacy in pregnancy.      We propose an open label, randomized controlled non-inferiority comparison of DHA-PPQ and     AS-AQ for treatment of uncomplicated malaria in pregnancy in second and third trimesters to     assess safety, tolerability and efficacy of DHA-PPQ. Outcomes of interest include     PCR-corrected cure rates at days 28 and 42, maternal haemoglobin levels at days 14 and 42,     prevalence of congenital abnormalities and pregnancy wastage. Proportions and percentages     will be described at 95% Confidence Intervals and compared using chi-square tests. Parametric     and non-parametric tests of significance will be applied as appropriate to determine     significance of differences in outcomes between the treatment groups.   "
156820|NCT01231100|"     The purpose of this study is to investigate whether or not care guided by hospitalists     equipped with hand-carried ultrasound echocardiography reduces the length of stay of general     medicine inpatients who were referred for standard echocardiography.   "
156821|NCT01231087|"     Obese patients are going to be submitted to indirect calorimetry pre-operatively and we are     going to repeat the same exam 6 months after bariatric surgery (post Roux-en-Y gastric Bypass     surgery). They are going to do also body composition analysis in both moments.      The investigators are going to compare the results to see if the bariatric surgery increases     their energy expenditure.   "
156822|NCT01231074|"     Recent but limited short term studies have shown that Metformin can slow down weight gain in     obese children and in children with psychotropic-induced weight gain, two distinct pediatric     populations that are at risk for obesity related co-morbid conditions. The purpose of this     study is to conduct a long term prospective pilot cohort study to investigate the use of     Metformin to prevent or decrease weight gain in two cohorts of children: 1) children with     psychotropic induced weight gain on Metformin and 2) children with BMI above the 95th     percentile on Metformin. Both study populations will be enrolled in a lifestyle weight     management program   "
156823|NCT01231061|"     Demonstrate the technical feasibility of treating spine metastases with image-guided     radiosurgery/SBRT   "
156824|NCT01231035|"     The main objective of the project is to assess the long-term prognostic impact of residual     platelet reactivity after optimal antiplatelet therapy in a large cohort of patients with     acute coronary syndrome undergoing invasive strategy.      Follow-up length will be at least 24 months. The primary end-point of the study will be a     composite of death, myocardial infarction, urgent target vessel revascularization, stent     thrombosis or stroke.   "
156825|NCT01231022|"     The investigators want to know the role of Peripheral hematopoietic stem cell infusion in     avoiding Drug Induced Liver Injury,and also try to research SNPs genotyping associated with     Drug Induced Liver Injury.   "
156826|NCT01231009|"     Aim of present study is to determine whether corticosteroids and vestibular exercises are     equal effective in the recovery of balance in patients with acute vestibular neuritis.   "
156828|NCT01230983|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Dexrazoxane     may lessen the side effects of chemotherapy.      PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without     dexrazoxane and with or without high-dose methotrexate in patients with acute lymphoblastic     leukemia or advanced lymphoblastic non-Hodgkin's lymphoma.   "
156829|NCT01230970|"     This trial will assess the intratumoural pharmacological activity of BN83495 by changes in     intratumoural levels of sex hormones and associated inhibition of steroid sulphatase (STS)     activity.   "
156830|NCT01230957|"     This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to     elderly individuals at risk of exposure to Clostridium difficile because of impending     hospitalization or residence in a care facility.      Primary Objectives:        -  To describe the safety profile of subjects in each of the study groups.        -  To describe the immune responses elicited by toxoid A and toxoid B of subjects in each          of the study groups.      Observational Objective:        -  To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.   "
156831|NCT01230944|"     This is a long-term follow-up of a prospective randomized trial comparing open and     laparoscopic Nissen fundoplication.   "
156832|NCT01230931|"     Fractures of the acetabulum are considered rare in the general community, but are quite     common in major metropolitan areas and tertiary care centers. These fractures are some of the     most complex and challenging injuries to successfully treat in the orthopaedic field.     Extensile surgical exposures are required to access this unique structure that comprises the     cup of the hip joint. Large skin incisions, significant soft tissue dissection, and elevation     of periosteum and muscle from the intact and fractured fragments are often required for     anatomic reductions of the acetabulum and good outcomes. Thus, there are many sources of     intra-operative bleeding that can sum up to require strategies aimed at preventing bleeding     or replacing blood loss.      Cell-saver and transfusion of allogeneic blood products can replenish blood loss. The use of     cell-saver is a good solution, but it is quite expensive. Trained perfusionists are required     and cost over $400 per hour. Disposable products are also required for each patient. While     blood loss can be great, often not enough blood is captured, processed, and available for     return transfusion. Allogeneic blood transfusion is often routine. Appropriate blood is often     on short supply. The cost of processing, testing, and transfusion is also high: minimum of     $260 per standard unit of packed red blood cells. While risks of disease transmission are     rare, they exist and can have serious consequences to patients. Transmission can include CMV     (common), Hepatitis C (1:1,600,000), HIV (1:1,800,000), and bacteria (1:500,000). Transfusion     reactions are more common and include febrile reactions (1:100), allergic reactions (1:100),     hemolytic reactions (less common), and transfusion-related acute lung injury (1:5000).      Decreased operative times, aggressive electrocautery, ligation of identifiable vessels,     minimal soft tissue dissection or stripping, topical agents such as gel foams, and thrombins     are possible and available. But still, significant blood losses persist. Over the past     decade, platelet gel products and fibrin sealants have been developed and provide another     possible solution. There are some retrospective studies in the arthroplasty literature     indicating these are good hemostatic agents. There is also some literature from the general,     oral and maxillofacial, and spine surgical fields indicated these topical agents decrease     intra-operative blood loss. But there are no large prospective, randomized studies in     orthopedics, particularly traumatology, supporting the use of surgical hemostats.      This study protocol will use one surgical hemostat (Vitagel, Stryker). The study is a     prospective, randomized controlled trial to evaluate this type of topical agent's role as a     hemostatic agent in certain acetabular fracture types that require a non-extensile, posterior     approach. Three fellowship-trained traumatologists will be involved: Drs. Milan Sen, Tim     Achor, Josh Gary, Mark Prasarn, John Munz, and Andrew Burgess. Dr. Ambrose will assist in     analyzing the data and statistical outcomes.      Purpose of Project. The purpose of our study is to determine whether surgical hemostats can     minimize blood loss, need for allogeneic blood transfusions and their associated risks, and     costs in patients with certain acetabular fractures requiring operative fixation via a     non-extensile Kocher-Langenbeck surgical approach. Since surgical hemostats and other topical     agents like platelet gel products have also been linked with improved wound healing, a     secondary endpoint will be incidence of wound dehiscence and/or infections.      The investigators primary hypothesis is the topical hemostat will result in lower blood     losses intraoperatively and fewer units of perioperative blood product transfused.   "
156850|NCT01230697|"     The study includes the recruitment of patients with advanced renal cells carcinoma and     hepatocarcinoma in treatment with sorafenib. Multicenter cohort study. It is a prospective     observational study.   "
156851|NCT01230684|"     The purpose of the study is to compare two different types of imaging techniques to identify     endoleaks. Following the endovascular procedure, subjects are seen at one month to have     computed tomographic angiography (CTA) to confirm the graft is not leaking (endoleak). CTA is     the standard imaging technique used to identify endoleaks. This study will investigate if the     image technique color duplex ultrasound with contrast enhanced ultrasound (CEUS) is a good     tool to identify endoleaks too.   "
156853|NCT01230658|"     The purpose of this study is to assess anti-factor Xa concentrations in patients given     prophylactic enoxaparin after bariatric surgery.   "
156854|NCT01230645|"     RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic     rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 is     effective in reducing the inflammation caused by viral infections such as RSV (respiratory     syncytial virus).   "
156833|NCT01230918|"     The objective is to determine whether 99Technetium-NC100692 uptake in patients with ACS (MI)     can serve as a marker for scar formation as detected by contrast-enhanced MRI during the     process of myocardial remodelling after the ischemic insult.      Comparison of ACS and HCM Populations:      The primary objective is to determine whether TcNC100692 imaging is able to quantify the     extent to which myocardial fibrogenesis occurring early post myocardial infarction differs     from that in patients with hypertrophic cardiomyopathy.      The primary hypothesis is that since fibrogenesis is known to occur most intensely in the     first days to weeks post myocardial infarction, while it is a more protracted, less     predictable process in HCM, there will be significantly more TcNC100692 uptake in the early     post-ACS population than in the HCM population.      Control Population:      Normal control images will allow for differentiation of uptake in the myocardium.   "
156834|NCT01230905|"     Suppression of effects of androgens with male sex hormones, androgen suppression treatment     (AST), has been known to reduce deaths and prolong life in advanced prostate cancer. There     have, however, been concerns raised in previous studies that androgen suppression may be     associated with increased rate of heart attacks, particularly in older men. This study looks     at prostate cancer patients in The Ottawa Hospital Cancer Clinic to see if treating these     patients with androgen suppression is associated with a decrease in blood flow to the heart     muscles by using Positron Emission Tomography (PET) and brachial artery ultrasound.   "
156835|NCT01230892|"     Nebivolol is a novel blood pressure lowering drug with an additional effect on the inner     lining of blood vessels to release a compound called nitric oxide that can relax blood     vessels. Atenolol is a blood pressure reducing agent without the ability to release nitric     oxide and effect additional blood vessel relaxation.      The goal of this proposal is to compare Nebivolol and Atenolol with respect to the following     parameters:        -  Plaque within arteries supplying the heart in terms of its volume and composition as          assessed by ultrasound within these arteries.        -  Ability of small arteries in the heart to open up and deliver an enhanced blood supply          in response to drug called Adenosine (routinely used in the cardiac catheterization          laboratory) as assessed by pressure and flow detecting catheters within these arteries.        -  Ability of the inner lining of arteries that supply the heart to release a relaxing          compound called nitric oxide in response to injection of Acetylcholine (also used in the          cardiac catheterization laboratory) as assessed by squirting dye into these arteries        -  Local forces that affect blood flow in the arteries supplying the heart as assessed by          superimposing the above data into complex maps created offline at Georgia Institute of          Technology.      It is likely that Nebivolol causes the plaque within arteries supplying the heart to change     from the 'vulnerable' type to the 'stable' type plaque. There are several features of     vulnerable plaques that can be detected in arteries of the heart using intravascular     ultrasound (a small ultrasound camera that goes in the arteries of the heart). The     investigators hypothesis is that Nebivolol will prove superior to Atenolol in reducing     'vulnerable plaques', improve blood flow within the small arteries and the health of inner     lining of these arteries at the 1 year time point. The investigators plan to enroll 20     patients into the study (26 patient including dropouts) who will be randomized in a 1:1     manner to Nebivolol Vs Atenolol for 1 year and repeat evaluation at that time point.   "
156836|NCT01230879|"     The aim of the study is to investigate the relationship between aging and morphological     changes in the lung. 120 consecutive healthy volunteers over 60 years will be enrolled for     this trial.   "
156837|NCT01230866|"     The purpose of this study is to compare the effects (good and bad) on patients with prostate     cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks)     with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of     the treatments are similar or better.   "
156838|NCT01230853|"     The purpose of this study will be to evaluate the safety and tolerability of BAN2401 at     sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD).   "
156839|NCT01230840|"     To compare calcium and magnesium absorption within subjects with and without chronic     consumption of wheat dextrin.   "
156840|NCT01230827|"     The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in     patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with     active arthritis that have poor response to methotrexate.   "
156841|NCT01230814|"     This research study is about vaginal infections such as bacterial vaginosis, yeast     infections, and trichomoniasis. Usually, these infections can be treated with medication, but     sometimes they come back after treatment. Researchers want to know if using vaginal     suppositories can decrease the risk of vaginal infections. Participants will include 234     women who are sexually active (greater than or equal to 4 episodes of sex with men during the     past month), HIV-negative, 18 to 45 years old, with bacterial infection [vaginosis and/or     vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis] detected by laboratory testing     at a screening visit. Women will receive vaginal suppositories containing drug or inactive     ingredients (placebo). Participation in the study will be about 12 months. Study procedures     include: urine and blood tests, physical exams, and questionnaires.   "
156842|NCT01230801|"     A Phase 1/2, open-label, multicenter, multiple dose escalation study of BMN 701 administered     by intravenous infusion every 2 weeks over a 24-week treatment period to patients with     late-onset Pompe disease.   "
156843|NCT01230788|"     This is a pilot study of a drug called rituximab used together with other drugs—prednisone,     etoposide, and ifosfamide. Prednisone, etoposide, and ifosfamide have been used as part of     standard chemotherapy for relapsed Acute Lymphoblastic Leukemia (ALL). Rituximab was approved     by the Food and Drug Administration in 1997. However, the use of rituximab with prednisone,     etoposide, and ifosfamide in pediatric patients with relapsed or refractory ALL is considered     experimental.      This study is for patients who have ALL in second or greater relapse, or in first relapse and     not responding to treatment.      The goals of this study are:        -  To see if using rituximab with prednisone, etoposide, and ifosfamide is beneficial to          leukemia treatment        -  To find out what side effects this combination of drugs can cause      A total of 15 participants (30 years old or younger) will be enrolled, over a period of 2     years.   "
156844|NCT01230775|"     This is a multicenter, phase III, randomized, subject and sponsor-blinded, placebo-controlled     study to determine the treatment effect of Anagrelide retard in subjects with Essential     Thrombocythaemia (ET) at defined risk (definition of risk criteria: see Inclusion Criteria     Section 5.1) The study is planned as a 2-stage procedure according to Bauer and Köhne: After     recruitment of 140 subjects an interim analysis with re-assessment of sample size is planned     in an adaptive manner.      As the confirmatory analysis will be based on a time-to-event evaluation (i.e. time to 1st     clinically significant ET related event), there is no stipulated observation time identically     applying for all subjects. Yet, with an interim analysis being performed after having     recruited 140 subjects - which is expected to be reached after 1 year - the estimated     observation time for a subject in stage I will also be about 1 year. (Details are explained     in the section Statistical Considerations).      Subjects will be randomized in a 1:1 ratio to one of the following two arms:      Group A: Anagrelide retard Group B: Placebo      An a priori stratification is planned for the JAK-2 mutational status. For exploratory     purposes a post hoc stratification is used for obtaining covariate adjusted results, for the     following other potentially predictive factors: sex, age, Factor V Leiden, and BMI.      Dosing will be started with 1 tablet per day for week 1 and will be titrated up according to     response (platelet reduction) to 2 tablets in week 2. Dosing may be further increased or     decreased according to platelet response in week 3 and 4. However, the maximum dose is 4     tablets (=8mg) per day. After week 4, the maximum dose to achieve optimal platelet counts     (<450 G/L) should be maintained (for visit schedule see study flow chart section IV).      To verify a treatment response, platelet counts must be evaluated at every visit. The     platelet count values will be withheld from the subjects for the duration of stage I or stage     II respectively. The subjects have to agree explicitly to this procedure by signing the     Informed Consent form.      This is a patient and sponsor-blinded clinical study. The trial medical is packaged in the     blinded fashion to keep the patient unaware (blinded) towards the actual treatment group they     were randomized to. The sponsor functions (including medical monitor, pharmacovigilance     manager, clinical project manager, trial data manager and trial statistician) with stay     blinded in the course of the study until the database lock. Randomization scheme will be     prepared by an independent statistician (not otherwise involved in the study), and will be     stored securely with no access to it by the sponsor functions mentioned above. The process of     randomization (provision of the individual drug-allocation information to the subjects) will     be carried out by a trained staff by Harrison, in adherence to the procedures to keep the     other blinded functions unaware of this information (blinded). Unblinding envelopes, which     contain the treatment code per patient number for identification of treatment in case when a     safety-relevant unblinding needed, will be stored at the sponsor's site. At the end of the     study, verification of the extent of maintaining the blind by checking if the envelopes have     been broken, will take place and will be properly documented. If the sealed envelope will     broken to provide treatment identification, the date of breaking the code, the initials of     the person who broke the code and the reason will be stated on the envelope.      The operational details on the blinding procedures are outlined in the relevant working     guidelines (ARETA Study Working Guideline for idv staff and ARETA Study Working Guideline for     Harrison, each in its current version).      Investigator will not be blinded in this study, i.e. in case of a medical need individual     patient management will be driven by the full knowledge of the trial related interventions.     For the case, the sponsor will need to unblind a patient (e.g. due to safety reasons), the     above mentioned (in this section) envelopes will be used.      Only treatment naïve subjects, in respect to cytoreductive drugs with confirmed diagnosis of     ET (centralized re-evaluation according to WHO, 2008; see Section 6.2.1) and assessment of     JAK-2 status (centralized re-evaluation of JAK-2 status; see Section 6.2.2) will be enrolled.      As described above, stage I of the study will be considered as closed as soon as 140 subjects     have been recruited. The duration of stage II depends on the result of the re-assessment of     sample size.      Once stage I is finished, stage I subjects will enter into an extension period for a maximum     of three years.   "
156845|NCT01230762|"     The purpose of this study is to evaluate the long-term safety of dapoxetine in men with rapid     ejaculation.   "
156846|NCT01230749|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the     body does to the medication) and pharmacodynamics (what the medication does to the body) of     treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes mellitus     participants.   "
156847|NCT01230736|"     The purpose of this study to assess the safety and efficacy of changing to DuoTrav® from     prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination)     pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.   "
156848|NCT01230723|"     The objective of the study is to assess the superiority of the everolimus-eluting stent     (Endeavor Resolute®) compared with the everolimus-eluting stent (XIENCE V®) regarding     uncovered stent strut segments.   "
156855|NCT01230632|"     This study is to compare the effects of high fat overfeeding on metabolic risk factors in     children born though assisted reproduction technologies (ART) versus children conceived     naturally (controls). The investigators will utilize state of the ART measures to     characterize the physiological, endocrine and molecular responses to high fat overfeeding.      The investigators hypothesize that children conceived following ART will have greater     responses to high fat dietary challenge and that this will be associated with DNA     hypermethylation of genes that are involved in lipid metabolism.   "
156856|NCT01230619|"     RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic     rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568     ameliorates the nasal symptoms to low doses of grass pollen in healthy subjects with seasonal     allergic rhinitis.   "
156857|NCT01230606|"     This is a multi-center trial that will evaluate the safety, feasibility, and cost     effectiveness of discharging patients, who have had successful percutaneous coronary     intervention (PCI) and deployment of the AngiomaxTM closure device, 6 hours after against 24     hours after the procedure. Patients will be randomized in a 3 (test): 1 (control) fashion and     will have a study population of 600 patients over 6 investigational sites all within the     United States. Patients <65 years old will be chosen in order to stay within the low risk     group and will be followed up after 24 hours, 7 days, and 30 days via phone or office visit.     The primary endpoint will be a composite of major adverse cardiac and cerebral events, and     the incidence of major bleeding or vascular complications. Data acquired from the study, such     as blinded financial information and patient satisfaction surveys, will be used in order to     evaluate cost analysis and safety of the procedure.   "
156858|NCT01230593|"     An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the     blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to a     typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. The     chalazion may cause tearing, pressure on the cornea, and irritation, all of which contribute     to its morbidity. There are many anecdotal first line treatments for this condition,     including warm compresses to the eyelid, topical antibiotics, topical steroids, topical     combination antibiotic/steroid, and oral antibiotics. There have been no clinical trials to     compare the efficacy of any of these conservative treatments. We wish to determine the most     effective conservative medical treatment for chalazia.   "
156859|NCT01230580|"     The PIVOT trial aims to determine whether a strategy of switching to PI monotherapy is     non-inferior to continuing triple-therapy, in terms of the proportion of patients who     maintain all the drug treatment options that were available to them at baseline after at     least 3 years of follow-up, and to compare clinical events, safety, toxicity and health     economic parameters between the two strategies.   "
156860|NCT01230567|"     50 patients with non healing wounds will undergo biopsy to conclude wether there is an occult     etiology for the wound.   "
156861|NCT01230554|"     The objective of this one week, single group, bilateral, open-label study is to evaluate the     product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test)     when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted     soft contact lens.   "
156862|NCT01230541|"     Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects     on semen characteristics.   "
156863|NCT01230528|"     Reactive thrombocytosis (RT) in pediatric patients is common, but usually without symptoms.     The incidence of RT is different depending on age. Mostly, we reasoned that RT is a     phenomenon, nevertheless the diagnostic value of RT is little known. Therefore, the aim of     this study was to determine the association of RT and clinical or laboratory characteristics     in pediatric diseases.   "
156864|NCT01230515|"     The purpose of this study is to modify the opioid titration order sheet to meet the needs of     the outpatient hospice population and to conduct a pilot trial to assess feasibility,     utility, and derive preliminary efficacy data.   "
156865|NCT01230502|"     To determine whether long-term maintenance therapy with a single drug (Myfortic) applied     using advanced immunologic monitoring tools in selected patients can lead to superior native     kidney function at 2 years without resulting in increased acute rejection episodes or     deterioration of liver allograft function.   "
156866|NCT01230489|"     To evaluate the efficacy of honey as a post surgical exit site care process to promote     healing and prevent infectious bacterial colonization of newly created exit sites. It has     been shown in the medical literature that honey has properties that are conducive to healing     and the prevention of infection. In one study it was demonstrated that in urethral injury in     the rat treated with honey the injury healed with none of the usual formation of fibrous     tissue seen in such healing processes, that there was no reduction in the luminal diameter     usually seen, and that the cells lining the urethra were uncompromised in any way, i.e.     totally normal and healthy. We feel that if an exit site can be healed quickly with good     normal tissue being developed that the patient will have a much better chance to keep that     exit healthy reducing time, cost, and disruption of lifestyle. Other positive aspects of     honey are it has the low pH required for good healthy tissue healing, it works in the     presence of wound fluids, and it has never been shown to produce a resistant bacterial     strain.   "
156870|NCT01230437|"     The airways of the lung are lined by specialised cells called airway epithelial cells. As     well as being at the interface between the lungs and the air we breathe; airway epithelial     cell (AEC) function is altered in people with respiratory diseases such as asthma. AEC     secrete many mediators that contribute to asthma symptoms and these also contribute to     asthmatic inflammation in the lungs. The study of such cells is difficult because of their     location deep in the lungs. Nasal airway epithelial cells provide a useful and easily     accessible model of model of lower airway cells. This study will examine whether the asthma     medication Singulair (montelukast) can inhibit the inflammatory secretions of nasal AEC of     asthmatic patents who also have allergic rhinitis compared with patients who have asthma     alone. We will also examine if montelukast has differential modulating effects in these two     patient groups.   "
157303|NCT01224730|"     This is a Phase I study which will analyze any food-drug effects as well as QTc effects of     perifosine. Safety and efficacy will also be evaluated.      Patients who complete the first 24 days on single agent perifosine may have the opportunity     to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine +     perifosine; or 3) switch to the combination of sorafenib + perifosine.   "
156871|NCT01230424|"     A steroid (triamcinolone) 40 mg will be compared to placebo in a randomized     placebo-controlled clinical trial testing the effect of this steroid versus placebo given     into the study knee joint that has osteoarthritis (OA). The knee injection will be given once     every 12 weeks over two years for a total of eight knee injections. How well each participant     tolerates each injection and all the injections over time will be assessed. The safety of     getting a knee injection every 12 weeks will be assessed by collecting reported adverse     effects, knee examinations, and clinical laboratory tests. Participants will complete     questionnaires, X-ray, MRIs, and bone density tests as part of this study.   "
156872|NCT01230411|"     This is a pilot trial to collect data on the use of intravenous ibuprofen (IVIb) in the     treatment of an acute migraine attack. Data will be collected on the efficacy of IVIb in     subjects who are treated with study medication between 2 and 72 hours from time of onset of     headache.      Periodic safety and efficacy assessments will be performed prior to and after study drug     administration.      Null hypothesis: There is no difference in the proportion of subjects in the 2 treatment     groups (active treatment and placebo) who have pain relief at 2 hours after the completion of     the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain     level from severe or moderate decreased to mild or headache-free, respectively.   "
156873|NCT01230385|"     Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate     the safety and toleration of 2 different doses of lersivirine administered either fed or     fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD     (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be     evaluated.   "
156874|NCT01230359|"     Nutritional supplements like vitamin B6 and magnesium have demonstrated to have beneficial     effects in patients with autism spectrum disorders (ASD). The underlying theory for these     effects is that specific metabolic pathways in neuronal cells, e.g. the methionine cycle,     will be more balanced. Most studies have been focused on the clinical outcome with this     treatment. The present proposal will examine the effects on the different intermediates of     the methionine cycle (methylation and transulfuration capacity), suggested to play an     important role for the pathogenesis of ASD. The design is a prospective pilot study,     including 40 patients, aged 2-6 yrs, with newly diagnosed ASD. All participants will receive     the supplement (vitamin B6, magnesium; Kirkman formula) and placebo in a cross over design.     Metabolites in blood and urine will be measured prior to and at the end of the treatments in     the different groups. The results will then provide us with information, which will link     clinical outcomes with biological markers. Furthermore, the study has also the potential to     shed light on the pathogenesis of ASD.   "
156875|NCT01230346|"     This pilot clinical trial studies a culturally-informed counseling intervention in Latinas at     high risk for hereditary breast or ovarian cancer. A culturally-informed counseling     intervention may be an effective method to help people learn more about their cancer risk.   "
156876|NCT01230320|"     BACKGROUND: The fabrication of complete dentures traditionally involves a series of complex     technical procedures. Those procedures include two impressions for each jaw, the registration     of the relationship between the upper teeth and the patient's head and usually two     appointments for tooth try-in. However, recent studies have questioned the real need for such     complex procedures. Simplified methods could have similar results if compared with     conventional ones, and dentures would be delivered faster and with lower costs.      OBJECTIVES: This study aims to compare the effectiveness complete dentures fabricated with a     simplified or conventional method.      METHODS: Eighty edentulous patients who requested treatment by maxillary and mandibular     complete denture in a public dental clinic inside the University of Sao Paulo - Ribeirão     Preto Dental School will be randomly divided into two groups. Group S will receive new     dentures fabricated by a simplified method, whereas Group C will received new dentures     according to a conventional method. Participants will complete a questionnaire for denture     satisfaction and the oral health-related quality of life, 3 and 6 months after treatment. At     the same time, a specialist in dental prostheses will evaluate the quality of new dentures.   "
156877|NCT01230307|"     The central objective of this proposal is to establish that vitamin D supplementation in     heart failure patients with low vitamin D levels will have improved outcomes compared to     placebo. In addition the investigators will also evaluate the role of genetics in regard to     vitamin D and heart failure. The investigators will be evaluating what is currently a novel     approach of identifying patients with low vitamin D and treating this low vitamin D level.     The investigators will be able to evaluate the importance of vitamin D supplementation in     these patients and the role of genetics on our defined outcomes.   "
156878|NCT01230294|"     Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and     strain-echocardiography) for measurement of the right ventricular (RV) function .   "
156879|NCT01230281|"     This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after     administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma     concentration of C3G and the antioxidative markers such as total antioxidative capacity and     attack of free oxygen radical will be measured.      Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg     black bean seed coat extract.      This study, as an exploratory trial, does not required statistical hypothesis   "
156942|NCT01229462|"     This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed     combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in     patients with glaucoma or ocular hypertension who do not respond well to topical beta     blockers.   "
156880|NCT01230268|"     This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after     administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma     concentration of C3G and the antioxidative markers such as total antioxidative capacity and     attack of free oxygen radical will be measured.      Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg     Mulberry fruit extract.      This study, as an exploratory trial, does not required statistical hypothesis.   "
157065|NCT01227863|"     The primary objective of this study is to evaluate, through clinical parameters, the     effectiveness of your medicine topic Maxinom ® (dexamethasone, neomycin and polymyxin B -     Union Chemicals), comparing it to the topical medication Maxitrol ® (dexamethasone, neomycin     and polymyxin B - Alcon ) by the percentage of improvement (sustained response rate) at the     end of treatment, among the products studied.   "
156881|NCT01230255|"     Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) have     traditionally been treated surgically through emergent laparotomy. Intensivist-performed     bedside drainage of free intra-peritoneal fluid or blood [percutaneous catheter decompression     (PCD)] has been suggested as a less-invasive alternative to traditional open abdominal     decompression (OAD). This study assesses the relative efficacy of PCD vs. OAD in reducing     elevated intra-abdominal pressure (IAP).   "
156882|NCT01230242|"     This study aims to demonstrate that the expulsion rate is increased but acceptable when     inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'. The     investigators will compare the postplacental insertion expulsion rate estimate with rates     reported in the literature for 6 week postpartum insertion, which is currently the American     standard for IUD insertion postpartum. Secondary outcomes will also be examined;     endometritis, uterine perforation, continuation and pregnancy among others.   "
156883|NCT01230229|"     The aim of this study is to evaluate whether primary stenting with self expanding stent in     patients with peripheral arterial disease suffering from stable claudication due to     superficial femoral artery disease results in improved patient outcomes, compared to     conservative treatment alone as measured by improvement in Quality of Life scores at 12     months after treatment using established surveys. Patients will be followed up 24 months     after treatment. Planned recruitment and randomization of 100 patients was completed June     2015.   "
156884|NCT01230216|"     The purpose of this study is to evaluate the effect of intensive blood pressure control     compared to standard blood pressure control on progression of coronary atherosclerosis by     intravascular ultrasound in hypertensive patients with coronary artery disease.   "
156885|NCT01230203|"     Cumulative radiation dose, cost, contrast induced nephrotoxicity and increased demand for     computed tomography aortography (CTA) suggest that duplex ultrasonoraphy (DU) may be an     alternative to CTA-based surveillance. The investigators compared CTA with DU during     endovascular aneurysm repair (EVAR) follow-up.      Patients undergoing EVAR have radiological follow-up data entered in a prospectively     multicenter database. The gold standard test for endoleak detection was CTA. DU     interpretation was performed independently of CTA and vice versa.   "
156886|NCT01230190|"     To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD     in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting and     has proven IL-10 stimulating effects. Therefore it is thought to decrease AD severity in     young children (beyond the conventional treatment).   "
156887|NCT01230177|"     This survey is conducted to investigate safety and efficacy under the post marketed drug     utilization on the patient with rheumatoid arthritis (only for patients with an inadequate     response to prior conventional therapy) at the time of switching regimen from 10 mg twice a     week administration to 25 mg once a week administration.   "
156888|NCT01230164|"     An aberrometer measures visual aberrations by mapping how light rays travel through the eye     and by providing maps using colored gradients to represent the magnitude of refractive errors     of the eye.      The purpose of this study is to compare 4 different aberrometers -Wavescan (Visx Technology),     Zywave (Bausch & Lomb), Ladarwave aberrometer (Alcon Inc.) and Allegro Analyzer (Alcon Inc).     In particular, the investigators propose to focus on the ability of these devices to display     the higher order visual aberrations and to compare the quality of outputs from these 4     devices in normal healthy subjects.   "
156889|NCT01230151|"     The purpose of this study is to assess the cognitive performance in patients with advanced     Parkinson's disease receiving Deep Brain Stimulation (DBS) with settings predetermined     clinically to settings derived from a patient-specific computational model.   "
156890|NCT01230138|"     The purpose of this trial is to investigate the efficacy and safety of different doses and     dose administrations of FP187 compared to a placebo treatment in patients with moderate to     severe plaque psoriasis.   "
156891|NCT01230125|"     The objective of this clinical study is to compare the safety and efficacy of Mapracorat     Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain     following cataract surgery.   "
156892|NCT01230112|"     Study to examine the role of ITGAM molecule in normal control subjects with known genetic     variation in the ITGAM gene.   "
156893|NCT01230099|"     The purpose of this study is to test a communication intervention to support family     decision-making for patients with chronic critical illness.   "
156894|NCT01230086|"     Implantation of a cardioverter defibrillator (ICD) is the treatment of choice for primary and     secondary prevention of sudden cardiac death. Traditionally, intraoperative testing for     sensing and defibrillation capabilities of the ICD system is performed. Modern implantation     strategies suggest a non-testing approach because net-benefit of a testing versus a     non-testing strategy is questionable and because arrhythmia induction and defibrillation may     cause micro damage to the heart.      The study aims to investigate the contribution of different steps in the ICD implantation     procedure (implantation of the lead, shock delivery and induced ventricular fibrillation)     with respect to their potential damage to the heart measured by high sensitivity (HS)     TroponinT.   "
156895|NCT01230073|"     Remote monitoring of implantable cardioverter defibrillators (ICD) is a promising new     development in ICD therapy and has been shown to be technically feasible and safe.While data     on safety and feasibility of remote monitoring are in favour of this technology, patients´     treatment satisfaction has not been sufficiently investigated. To date, there is only one     small, non-randomised study investigating patients´ treatment satisfaction in highly selected     and highly motivated patients at the time of implantation and 12 months thereafter7.     Therefore, the aim of the San Remo Trial is to investigate factors that are associated with     patients´ willingness to accept the new method of follow-up on a broad basis of ICD     recipients and to determine their treatment satisfaction with ICD therapy in a randomised,     prospective trial.   "
156897|NCT01230047|"     This is a quasi-experimental evaluation of psychoeducational course focusing on mindfulness     and lifestyle changes for depression and anxiety; clients in active treatment group are     compared to those in a treatment-as-usual wait-list control group. The primary hypothesis is     that the psychoeducational course will result in lower levels of depression and anxiety as     compared to the wait-listed treatment-as-usual comparison group.   "
156898|NCT01230034|"     Numerous clinical and experimental data show that the elective treatment of diabetic     nephropathy should be based on drugs that inhibit the renin-angiotensin system (RAS).     Albuminuria is a marker of risk not only renal but also cardiovascular and diabetic patients     with concomitant non-diabetic nephropathy, on the other hand, drugs blocking the     renin-angiotensin system available so far, namely ACE inhibitors and angiotensin antagonists     II have proven effective in reducing proteinuria in power even if different therapeutic drug     to drug. ACE inhibitors are one of the most known and used treatment options for blocking the     renin-angiotensin system in patients with microalbuminuria. Drugs such as enalapril,     lisinopril and ramipril are standard therapy in diabetic patients with micro or     macroalbuminuria. However, it is still unclear whether their efficacy is, from this point of     view, the same or varies from drug to drug. This is particularly true in the diabetic     microalbuminuria, a condition in which there is sufficient documentation to prove that     ramipril is effective. The main objective of this study was to assess the magnitude and trend     of the time and to the antiproteinuric effect of antihypertensive 10-20mg/die imidapril     versus ramipril 5-10 mg / day in hypertensive patients with type 2 diabetes and     microalbuminuria.   "
156899|NCT01230021|"     This trial is conducted in Europe and United States of America (USA). The aim of this     clinical trial is to investigate the pharmacokinetics (at which rate the substance is     distributed and eliminated from the body) and the safety profile of catridecacog (recombinant     factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children     (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.   "
156900|NCT01230008|"     The use of Rituximab has been proposed to be useful and avoid the use of radiotherapy in     diffuse large B-cell lymphoma with bulky disease.We assess efficacy of adjuvant radiotherapy     in patients treated with R-CHOP   "
156901|NCT01229995|"     CAD/CAM technology has been introduced to the field of implant dentistry in the beginning of     1990's (Priest 2005). Since their introduction, the use of CAD/CAM technology in the     production of dental implant restorations has been rapidly expanding. However, little     evidence is currently present supporting its clinical viability (Henriksson 2003, Canullo     2007).      Therefore, the suggested prospective randomized study includes bone level placed Straumann     implants restored with transmucosal elements and crowns fabricated using either CAD/CAM     Etkon technology (Zirconia abutment and ceramic crown) or a conventional technique     (Crossfit titanium abutment and a ceramometal crown).      The aim of this randomized controlled clinical trial is to examine single-tooth implant     restorations in the esthetic zone. An esthetic area is defined as any area that is visible in     the patient's full smile. [3rd ITI consensus conference 2004] The rehabilitations will be     fabricated using two different techniques. Zirconia CAD/CAM (ZCC) implant restorations     (tests) will be compared to Titanium conventionally-fabricated (TCF) implant restorations     (controls) using, reproducible esthetic (objective/subjective) and biologic parameters.      This in vivo study is a randomized study with two groups of 15 patients with one implant each     for a total of 30 patients and 30 implants. The implants will be examined for successful     tissue integration according to the criteria of success (Buser et al. 1990) at every recall     visit.      In addition, the following parameters will be evaluated for each restoration:        -  Esthetic: A. Objective: PES/WES Score (Belser et al. 2009) from 1:1 digital photograph,          study casts, and spectrophotometric measurements, and B. Subjective: VAS questionnaire          for patients and VAS questionnaire from experts.        -  Biologic (mPI, mB, simplified GI, microbial sample, periapical radiograph for DIB, and          width of keratinized facial mucosa)      Finally, an evaluation of the mechanical, biologic and technical complications will be     performed at every recall visit. Mechanical complications would be defined as those     complications that involve the prosthesis such as abutment screw loosening, fracture of the     veneer material, fracture of the crown framework, abutment screw fractures, and implant     fractures. The category of biologic complications will include those complications that     involve the soft tissues (e.g., fistula, suppuration, bleeding, gingival inflammation, and     soft tissue dehiscence). Technical complications are defined as those related to restorative     components and crowns (e.g. crown emergence profile, abutment and crown fit, screw loosening,     ceramic fracture).   "
156902|NCT01229982|"     The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in     subjects with ocular hypertension or open-angle glaucoma.   "
156903|NCT01229969|"     Accidental falls in older adults are highly prevalent and a major source of morbidity. Over     30% of people aged 65 or older fall each year with about half of these cases being recurrent.     Falls may result in head trauma, bone fractures, and even death and are leading cause of both     nonfatal and fatal injuries in older adults. The Nintendo Wii Fit is a suite of exercise and     fitness video games using a balance board periphery developed for the Wii console. The     purpose of this study is to determine the feasibility and validity of the Nintendo Wii Fit,     in detecting balance problems in older community dwelling adults.20 ambulatory older adults     will be recruited to participate in this study.Subject will be asked to complete 1 study     visit. In this visit information will be gathered about the subjects overall health including     fall assessments. Qualified subjects will be randomized into two study groups where one group     will begin the study with Wii Fit testing followed by NeuroCom EquiTest evaluation and the     other group in reversed order.   "
156904|NCT01229956|"     RATIONALE: Studying samples of tissue from patients with cancer the in laboratory may help     doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in tissue samples from young patients     with acute myeloid leukemia.   "
156905|NCT01229943|"     This randomized phase II trial studies how well everolimus and octreotide acetate with or     without bevacizumab works in treating patients with pancreatic neuroendocrine tumors that     cannot be removed by surgery and have spread nearby or to other places in the body.     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Octreotide acetate may interfere with and slow the growth of tumor cells. Monoclonal     antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and     spread. Bevacizumab and everolimus also may stop the growth of pancreatic neuroendocrine     tumors by blocking blood flow to the tumor. It is not yet known whether giving everolimus and     octreotide acetate together is more effective with or without bevacizumab in treating     pancreatic neuroendocrine tumors.   "
156943|NCT01229449|"     The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen     plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg, acetaminophen compared with a     combination of 400 mg ibuprofen plus 25.6 mg codeine (Nurofen Plus®) and a combination of     1000 mg acetaminophen plus 30 mg codeine (Panadeine® Extra) in terms of total analgesic     effect, peak analgesic effect, onset and duration of action and the subject's overall     assessment of the study medication.   "
181638|NCT00222131|"     Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in     NUD patients   "
157098|NCT01227434|"     This study will determine the efficacy of the small molecule CDK4/6 inhibitor PD 0332991 (as     measured by progression free survival at 6 months) in patients with recurrent glioblastoma     multiforme or gliosarcoma who are Rb positive. A total of 30 patients will be treated; 15     will undergo a planned surgical resection and receive drug for 7 days prior to surgery,     followed by drug after recovery from surgery, and the other 15 patients will receive drug     without a planned surgical procedure.   "
156906|NCT01229930|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Cediranib maleate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known     whether carboplatin and paclitaxel are more effective when given with or without cediranib     maleate in treating patients with cervical cancer that cannot be removed by surgery.      PURPOSE: This randomized phase II trial is studying giving carboplatin and paclitaxel     together with cediranib maleate to see how well it works compared with giving carboplatin and     paclitaxel together with a placebo in treating patients with metastatic or recurrent cervical     cancer that cannot be removed by surgery.   "
156907|NCT01229917|"     The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus     rhamnosus GG during rhinovirus infection.   "
156908|NCT01229904|"     Post traumatic Stress disorder (PTSD) is a common condition for persons who have served in     the Armed services during combat or deployment. Treatments include medications, cognitive     behavioral therapy, and other social support mechanisms.      Our aim in this project is to critically evaluate the effects of a novel music therapy     intervention on the symptoms of PTSD. Estimates developed by the Global Burden of Disease     Study reveal that mental illness accounts for over 15% of the burden of disease on health and     productivity in established market economies--more than the disease burden caused by all     cancers combined.[1] Perhaps no industry has had the burden of mental disorders affect its     labor force as severely and pervasively as the Armed Forces.      Post-Traumatic Stress Disorder (PTSD) is a common sequelae of severe emotional trauma that is     often associated with combat exposure. The condition has been well documented in returning     soldiers and is characterized by recurrent and distressing thoughts and feelings related to     the trauma, persistent avoidance of reminders of the trauma, and increased arousal that     disturbs sleep, concentration, and the ability to modulate anger. Persons suffering from PTSD     often have difficulty relating to others, leading to loneliness and isolation, which further     intensifies their psychiatric symptoms. Current treatment options for PTSD include     psychotherapy, medication management, or a combination of those. Although these treatments     have been shown to be effective, returning soldiers are often hesitant to seek and adhere to     mental health therapies. PTSD-related avoidance, including difficulty trusting, may serve as     a barrier to seeking or completing treatments. Furthermore, some PTSD medications have     unacceptable side-effects in some individuals. The need is great, therefore, to identify and     promote safe, effective strategies for self-management of PTSD among Veterans.   "
156909|NCT01229891|"     The aim of this study is to evaluate the possible effects of daily intake of yogurt drink     fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic,     metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM).   "
156910|NCT01229878|"     This is a double-blind placebo controlled pilot study to determine if vitamin D     supplementation in hemodialysis (HD) patients will improve physical function and cognition.     HD patients have a high prevalence of vitamin D deficiency, cognitive impairment, and     physical impairment. Despite standard clinical care with active IV vitamin D during dialysis,     HD patients still have markedly low levels of nutritional or dietary vitamin D. IV treatment     with vitamin D during dialysis is aimed at treating HD related bone disease. Recent     literature shows that oral or nutritional vitamin D has multiple extra-skeletal effects     including improvement in cognition and physical function. In this study, the investigators     plan to administer oral vitamin D to vitamin D deficient HD patients already receiving     standard care with IV vitamin D therapy. Patients will be randomized to receive either     placebo or 50,000 IU of vitamin D (cholecalciferol) weekly for 6 months. The investigators'     specific aims are to 1) Assess the benefits of correcting nutritional vitamin D deficiency on     cognitive and physical function in HD patients receiving routine standard of care, 2) Assess     the feasibility of recruiting HD patients for this study, and 3) Evaluate the proposed     regimen for safely and effectively increasing nutritional vitamin D levels with oral     supplementation. The investigators anticipate that correction of nutritional vitamin D     deficiency to optimal levels will improve the high prevalence of cognitive impairment and     physical impairment in this population. These results will be used as evidence to support a     larger study aimed at treating nutritional vitamin D deficiency in all patients receiving HD.     These results may also contribute to a change in current guidelines which place little     emphasis on the monitoring and treatment of nutritional vitamin D levels in HD patients.     These results are important for the Veteran dialysis population since many of them are     required to perform high-level cognitive tasks such as management of complex medical regimens     and physical tasks such as orchestrating independent transportation to and from HD sessions     and multiple physician appointments.   "
156911|NCT01229865|"     The purpose of this study is to examine the safety and evaluate the response of VB-111 on     DTC.   "
156912|NCT01229852|"     Deep shaped-field transcranial magnetic stimulation is a new type of transcranial magnetic     stimulation technology which may provide a drug-free method for treating fibromyalgia.      The purpose of this study is to determine the effectiveness and the durability of effect of     Deep shaped-field repetitive transcranial magnetic stimulation (rTMS) in men and women     diagnosed with fibromyalgia.   "
156913|NCT01229839|"     TACE is considered the standard treatment for unresectable HCC on the basis of the fact that     there are no alternative to curative procedures.But the optimal combined regimen is still     unclear. One of the controversy is do the protocol should contain lipiodo and how to     executer. The investigators hypothesize that TACE without mixing the chemotherapy with     lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.   "
156914|NCT01229826|"     The purpose of this study is to gain additional information regarding use of Magnetic     Resonance Elastography (MRE) for uterine fibroid characterization. In this study, the     investigators will use a new noninvasive technology, MRE, to further characterize the elastic     properties of the uterine fibroids. To date, very little is known concerning how the tissue     composition of the uterine fibroid may affect its treatment with Magnetic Resonance Guided     Focused Ultrasound (MRgFUS).      In this study, the investigators will use a new noninvasive technology, magnetic resonance     elastography (MRE), to further characterize the elastic properties of the uterine fibroids.     This information will be gathered during routine magnetic resonance imaging for symptomatic     uterine fibroids. It is known that some fibroids with increased T2-signal on Magnetic     Resonance Imaging(MRI) can be more difficult to treat.      This information will be gathered during routine magnetic resonance imaging for symptomatic     uterine fibroids.   "
156915|NCT01229813|"     Patients with metastatic colorectal cancer will be treated with chemotherapy according to     investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will     be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients     KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment,     patients who has responded (complete response/partial response versus stable disease) will be     randomized to maintenance treatment. Patients with KRAS WT will be randomized to either     bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be     randomized to either bevacizumab, or metronomic capecitabine. Translational research is     performed, with purpose to find predictive factors in blood and tumor tissue.   "
156947|NCT01229397|"     The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL     2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline     for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as     reference.   "
156916|NCT01229800|"     : In several studies comparing of sodium phosphate solutions versus PEG, both regimen had     similar efficacy of bowel cleansing and sodium phosphate solutions are more acceptable to     patients because patient are required to consume smaller volume. But sodium phosphate     solutions are associated with fluid and electrolyte disturbances, so use of sodium phosphate     solution in routine medical check-up of outpatients is problematic. PEG can provide a rapid     peroral approach to colon lavage without causing fluid and electrolyte disturbance. However,     the need to ingest a large volume of fluid reduces patient compliance, and results in     suboptimal bowel preparation. In order to overcome this disadvantage, several studies proved     that split dose of PEG regimens were better quality preparation and more acceptable than     single dose regimens. In Korea, need for outpatient or screening colonoscopy without     laboratory test is increasing and split dose of PEG is used more frequently than other     country in bowel preparation because of safety. But, superiority of split dose of PEG to     sodium phosphate solution has not been demonstrated. The study was not yet existed about     comparison of split dose PEG solution with sodium phosphate solution for bowel cleansing and     tolerability in colonoscopy preparation. To use split dose of PEG in bowel preparation with     medical evidence, we want to demonstrate split dose bowel preparation with PEG compared to     sodium phosphate solutions provide a better colon cleansing efficacy and similar     tolerability.   "
156917|NCT01229787|"     Obesity has been recognized as a risk factors for developing asthma. In a cohort of 5384     children aged 15-17, we aim to:        1. To investigate the association of asthma prevalence at age 15-17 with body mass index          (BMI) at age 15-17 and BMI at age 11-12 years Part II        2. To investigate the association of BMI in adolescence and BMI at age 11-12 years with:             1. Prevalence of allergic sensitization             2. Lung function             3. Levels of airway inflammation at age 16-18 years             4. Severity of asthma      Secondly, to assess diet and physical activity involvement as effect modifiers in these     possible associations.   "
156918|NCT01229774|"     The primary aim of this study is to test if etoricoxib decreases the perioperative blood loss     compared to diclofenac.      Secondary questions to be explored are:        -  Does etoricoxib prevent Heterotopic ossification after Total Hip Arthroplasty as well as          diclofenac ?        -  Do diclofenac and etoricoxib both reduce pain at rest and on movements?        -  Does etoricoxib compared to diclofenac reduce the amount of rescue medication          (Oxycodon)?        -  Does etoricoxib improve gastrointestinal tolerability compared to diclofenac?   "
156919|NCT01229761|"     The purpose of this study is to find ways to improve infant health and survival among infants     whose mothers are HIV-infected but who do not themselves have HIV.   "
156920|NCT01229748|"     The investigators propose a randomized controlled trial with five aims: 1. To investigate the     engagement potential and effectiveness of a family-centered intervention (MDFT) and Family     Motivational Interviewing Intervention (FMII)/group for teens with alcohol-related crises; 2.     To explore differential treatment effects with comorbid adolescents; 3. To examine the role     of motivation and family factors as treatment mediators; 4. To examine long-term abstinence,     patterns and predictors of relapse up to 18 months follow-up; and 5. To compare the total and     net monetary benefits to society of MDFT, FMII/group, and standard care.   "
156921|NCT01229735|"     To assess the long-term effects of levetiracetam on retention rate in subjects with     refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant     antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.   "
156922|NCT01229722|"     The main aim of this phase II proposal is to continue and complete development of a cellular     phone-based system that assists patients with their medication adherence. Adherence reports     will be developed with feedback from patients and providers. Software for patients to report     their four day recall adherence through text messaging or short message service (SMS) or     interactive voice response (IVR) will be built. An initial qualitative study will evaluate     the adherence reports, 4-day adherence recalls, and inform the development of content for     reminder text messages that could be resistant to user fatigue. A redesigned system will be     tested through a 3-week longitudinal study of 15 patients with human immunodeficiency     virus/acquired immunodeficiency syndrome (HIV/AIDS). An intervention module will have an     analytics engine to track adherence levels and personalize delivery of reminder messages. A     clinic appointment module will perform patient appointment reminders. The final system with     these modules will be tested through a 24-week efficacy study. A total of 115 patients and     providers will be involved in the three user studies.   "
156923|NCT01229709|"     This study is a randomized, controlled trial of Mindfulness Based Tinnitus Reduction (MBTR)     vs. Treatment As Usual (TAU). This study aims to determine patient's benefit from     participating in an 8-week MBTR program as measured by a reduction in clinical symptoms, if     present, and a tinnitus symptom perception shift. Sixty-four tinnitus patients who have     previously received Tinnitus Counseling (TAU) at the UCSF Audiology Clinic under the     direction of Robert Sweetow, PhD will be invited to participate in the MBTR study. Subjects     will be randomly assigned to the experimental and control groups of 32 each. All subjects     will have received Tinnitus Counseling at least 6-months prior to entry into the study.     Tinnitus symptom activity and discomfort as well as psychological outcomes will be assessed     by self-report questionnaires. The primary outcome measure is the Tinnitus Handicap Inventory     (THI) measuring tinnitus symptom severity. The secondary outcome measures include the     Tinnitus Visual Analogue Scale (TVAS), the Symptom Checklist-90-Revised (SCL-90-R), Hamilton     Anxiety and Depression Scale (HADS), and the Five Factor Mindfulness Questionnaire (FFMQ). In     addition to tinnitus symptom severity, secondary outcome measures are used to measure change     in mindfulness and other clinical symptoms such as anxiety and depression, if they exist. The     experimental group will complete measures at pre-, post-, at 3-months and 12-months     follow-up. A 12-month follow-up assessment will be conducted with the experimental group to     identify any enduring effects of the treatment. The control group will fill out measures at     pre-, post-, and 3-month time periods. The 12-month follow-up will be conducted with the     experimental group only and will be the uncontrolled portion of the study.      The purpose of this study is to 1) Design and execute an MBTR program for patients with     tinnitus within the UCSF Department of Audiology. 2) Determine patient's benefit from     participating in an 8-week MBTR program as measured by a decrease in tinnitus distress, and a     reduction in clinical symptoms (i.e., depression, anxiety), if present. 3) Compare the     responses on study measures to those of the control group. 4) Collect follow-up data at 6-     and 12-months post intervention to assess enduring effects, if any, in the experimental     group. 5) Use the data and patient feedback to modify UCSF's Audiology program and guide     future programming in regards to the treatment and care of patients with tinnitus.   "
156924|NCT01229696|"     Research study to determine the relationship between perineural catheter tip location     relative to the sciatic nerve bifurcation and postoperative analgesia for continuous     popliteal nerve blocks.   "
156925|NCT01229683|"     Research study to determine the proportion of cases in which an interscalene brachial plexus     nerve block produces hand and forearm anesthesia.   "
157027|NCT01228357|"     The purpose of this study is to determine whether genetic information associated with     individual depressive symptoms.   "
173019|NCT00098163|"     The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine,     ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.   "
156926|NCT01229670|"     Heart failure (HF) is a major and increasingly common cardiovascular syndrome, and is the end     result of many cardiovascular disorders. It has been reported that HF patients with     pharmacological therapy often remain burdened by dyspnea and fatigue, diminished exercise     tolerance, reduced quality of life, recurrent hospitalizations, and early mortality. HF is     associated with neurohumoral changes as the body attempts to reverse the effect of reduced     cardiac output and organ perfusion. Persistent neurohumoral excitation, however, actually     results in deterioration of myocardial function with inflammatory response, end-organ damage,     and skeletal muscle derangement, which lead to worsened exercise capacity.      Physical training can have beneficial effects on neurohumoral, inflammatory, metabolic and     central hemodynamic responses, as well as on endothelial, skeletal muscle and cardiovascular     function, leading to improvement in functional capacity and quality of life. All these     training-induced changes can effectively counteract the progression of deleterious     compensatory mechanisms of HF.      Several lines of evidence suggest greater aerobic and cardiovascular adaptations after     high-intensity exercise than with moderate levels in patients with coronary artery disease or     left ventricular dysfunction function and in healthy subjects. Aerobic interval training     (AIT) involving periods at 90% of VO2peak has been shown to rescue impaired cardiomyocyte     contractility, attenuate myocardial hypertrophy, and reduce myocardial expression of atrial     natriuretic peptide in animal model of post-infarction heart failure. However, underlying     mechanisms of AIT-improved regulations remain unclear.      The different effects of AIT and moderate continuous training (MCT) on hemorheology,     atherothrombosis or angiogenesis modulated by erythrocyte, monocyte or EPC in patients with     CHF have been not investigated yet. Accordingly, the investigators will conduct this     three-year study to clarify how the two exercise trainings affect cardiovascular     hemorheological characteristics and atherothrombosis/ angiogenesis-related variables in     patients with chronic heart failure. The investigators expect that these results obtained     from this study can aid in determining appropriate exercise intervention to improve aerobic     fitness as well as simultaneously improve hemodynamic control and minimize the risk of     thrombogenesis in patients with CHF.   "
156927|NCT01229657|"     To evaluate the anatomic and visual outcomes in patients with initially closed macular holes     after vitreoretinal surgery and with one to seven years of follow-up.   "
156928|NCT01229644|"     The purpose of this study is to evaluate the antitumor efficacy of crenolanib (CP-868,596) in     patients with recurrent high grade glioma and in patients with low grade glioma.   "
156929|NCT01229631|"     The objective of this study is to determine whether enhanced micronutrient intake in the form     of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in     chronic periodontitis patients prior to standard non-surgical treatment.   "
156930|NCT01229618|"     Current imaging options do not assess prostate cancer well. This study will combine two     magnetic resonance imaging modalities, MRI and MRSI, in order to determine the utility to     physicians and patients with prostate cancer in making treatment decisions and seeing how     well various types of treatment work. Hyperpolarized pyruvate (13C) is an investigational     product that may enhance the imaging capability of MRI and MRSI. Hyperpolarized pyruvate will     be injected into the body to determine how it is metabolized and how it's metabolism can be     assessed using MR imaging.      The purpose of this study is to determine the safety and metabolism of hyperpolarized     pyruvate in humans, and how this can be used to increase the effectiveness of MR imaging with     regards to patient care.   "
156931|NCT01229605|"     The standard therapy for patients who have locally advanced breast cancer is to receive     chemotherapy before surgical removal of tumor. This is called neoadjuvant chemotherapy (NAC).     Chemotherapy is used to shrink the tumor before surgery, which sometimes may allow for a     smaller portion of the breast to be removed. Receiving chemotherapy before surgery may     sometimes also allow for smaller portions of the breast to be removed. Getting chemotherapy     prior to surgery may also control any hidden metastatic disease and thereby decrease the risk     of cancer relapse. Pre-surgery chemotherapy is a standard management approach for locally     advanced breast cancer.      Different combinations of drugs can be used as part of the pre-surgery chemotherapy. The     purpose of this study is to determine if using a chemotherapy regimen of TC is effective way     to manage locally advanced breast cancer (Stage IIA- IIIB) when the TC is given before     surgery. The investigators also hope this study will help us to better understand how the     tumor tissue is affected by this combination of chemotherapy drugs.      The TC drug combination is FDA approved for use in treating breast cancer, and it has been     shown to be equally effective as other commonly used chemotherapy regimens when used after     surgery; but, the TC drug combination has not yet been studied in conjunction with NAC for     use before surgery. The investigators will be studying the combination of TC used before     surgery as a means of possibly shrinking the tumor.   "
156932|NCT01229592|"     In recent years, several new methods for treatment of catheter-related bloodstream infections     (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable     success [1-10].      Long-term tunnelled central venous catheters provide a reliable access for administration of     chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of     complications such as bacteremia. The need to preserve these intra-vascular devices as long     as is possible in patients in whom conventional treatment was failed makes emerge antibiotic     lock-technique.      Ethanol lock-therapy was demonstrate her utility in this cases. But no study has yet been     published using the ethanol lock-therapy as a prophylactic therapy in catheter related     infections, neither her application in short-term CVCs.      Objectives: To investigate the value of a ethanol-lock solution in the prophylaxis of     non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit     (HPSICU).      Methods: An academic, prospective, randomized and controlled clinical trial is proposed.     Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms (ethanol-lock     or control group with conventional measurements such as anticoagulants). In the follow-up     period, we will register all necessary data to evaluate the end-points of study (CBRSI rate,     catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to     ethanol).   "
156944|NCT01229436|"     This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the     affected fingers and the patient and physician reported treatment satisfaction and disease     severity and their relation to ROM. Recovery to normal activities, recovery time (How long     overall, time to use hand, time to return to work or daily activities, amount of work or     daily activity time missed or reduced and affects on productivity and daily activities) will     be assessed via patient diary. Use of concomitant analgesic medications will be recorded and     total healthcare resource utilization (HCRU).   "
156945|NCT01229423|"     This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the     augmentation of eyelashes in Korean women.   "
156946|NCT01229410|"     This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal     administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery     System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.   "
156933|NCT01229579|"     Pakistan is one of the 4 developing countries where cases of poliomyelitis are still being     identified. Despite the incessant efforts by WHO and UNICEF, this disease is far from     control. There is a need to develop new and innovative strategies to contain the disease and     eradicate it from the countries where new cases continue to be identified.      Zinc is an essential component of scores of enzymes in the human body. Recent reports have     indicated that this trace element along with other micronutrients enhances the protective     functions of immune cells. Moreover, zinc deficiency leads to dysregulation of balanced host     responses to infection resulting into decreased antibody production and suppressed immunity.     Zinc is also an essential cofactor for thymulin which is known to modulate cytokine release     and induce immune cell proliferation. Zinc deficiency is also found to impair an individual's     epithelial barrier function, which may further depress the vaccine entry into the mucosal     cells.      Role of zinc in the prevention of diarrheal diseases and other infections in children is well     documented. However, there are very few reports about its contribution to enhanced immunity     by supporting body's natural defense system.      Zinc insufficiency is widespread in socioeconomically deprived children in South Asia and the     recent most national nutrition survey (2003) . Moreover, diarrhea is also very common in     infants in Pakistan. Such diarrheal episodes can limit entry of attenuated polio virus into     the mucosal cells, thereby, leading to inadequate immune response. Association between recent     diarrheal history and increased vaccine failure in infants has been shown in a study from     Brazil. The recent Lancet Nutrition series has also recommended regular zinc supplementation     to address child undernutrition and stunting and underscored the need to treat diarrheal     episodes with zinc to expedite recovery. Other recent studies of zinc supplementation in low     birth weight infants in South Asia have also shown significant improvement in diarrheal     disease burden and mortality.      On the basis of these lines of evidence, it is possible that some of the cases of vaccine     failure in this region could be a consequence of compromised immunity and, hence, diminished     response to OPV. This could potentially be reversed by addressing such gross undernutrition     and micronutrient deficiencies. It can thus be hypothesized that zinc supplementation at     community scale would enhance the immune response in infants to OPV.      In order to test this research question, the investigators propose to undertake 12-month     randomized controlled trial among a cohort of Pakistani infants of 0-14 days of age. Such a     trial would enable us to understand the synergistic role of zinc (if any) with OPV in     enhancing immune response against polio and sero-conversion rates.   "
156934|NCT01229566|"     The primary objective is to determine the efficacy of AKR963 compared to placebo and active     comparator in lowering fasting triglyceride levels in patients with very high fasting     triglyceride levels ≥ 500 and ≤ 1500 mg/dL.   "
156935|NCT01229553|"     The primary objective of this study is to measure efficacy of our new protocol by monitoring     the results of our routine respiratory cultures at the end of the new standard treatment, and     during routine visits for 1 year from initiation of therapy for Staphylococcus aureus. The     secondary objective will include determining the clinical course (pulmonary exacerbations,     antibiotic use, hospitalizations, pulmonary function tests) of patients who underwent the     protocol.   "
156936|NCT01229540|"     Retinal neovascularization of diabetic retinopathy might be associated with genetic risk     factors and environmental risk factors.   "
156937|NCT01229527|"     The purpose of this randomized double-blind trial is to define the correct dosage of     Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to     analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and     Analgesia) is a good method during colonoscopy, evaluating pain control, discharge time and     side effects.      90 patients undergoing colonoscopy will be enrolled.   "
156938|NCT01229514|"     General anesthetic medications have been shown to cause neuronal cell death in the brains of     infant rodents. Ethanol and general anesthetics both act on NMDA and GABA receptors,and     appear to have similar mechanisms of toxicity in the immature rodent brain. Functional MRI     (fMRI) is a technique developed for mapping brain activation and has been utilized to examine     how the brains of children with a history of early exposure to ethanol function differently     from children without such a history. This study will utilize fMRI to look for specific     changes in brain activation patterns in children with a history of early exposure to general     anesthesia, as compared to children without such exposure.   "
156939|NCT01229501|"     Endothelial dysfunction, or abnormal functioning of the lining of blood vessels, appears to     be a key process in the development of cardiovascular disease. Endothelial dysfunction     appears to be caused by both sleep disordered breathing and obesity. As endothelial     dysfunction is among the first clinical marker that predicts future cardiovascular events,     understanding molecular mechanisms leading to impairment of endothelial function is very     important. Endothelial function requires the proper functioning of endothelial nitric oxide     synthase (eNOS). eNOS activity is tightly regulated by caveolin-1, a protein important in the     formation of cellular structures called caveolae. Low levels of caveolin-1 facilitate optimal     nitric oxide synthesis in endothelial cells as caveolin-1 helps to spatially organize eNOS in     close proximity to signaling proteins that are important for eNOS activation. In certain     diseases however, the balance of caveolin-1 and eNOS can be disrupted resulting in impaired     nitric oxide synthesis and leading to endothelial dysfunction.      The investigators therefore seek to characterize levels of caveolin-1, and correlate this     with the presence or absence of sleep disordered breathing, obesity, and cardiovascular     disease. The current IRB protocol covers the performance of fat biopsies on subjects who have     recently completed a sleep study either in the Center for Sleep Medicine or in our sleep     laboratory and were found to have sleep disordered breathing or no sleep disordered     breathing, subject with sleep disordered breathing who have been treated successfully with     continuous positive airway pressure for 3-6 months, and subjects undergoing other studies in     our lab who are obese or non-obese and subjects who have known cardiovascular disease and     subjects without known cardiovascular disease.   "
156940|NCT01229488|"     The purpose of this study is to demonstrate the ability of the OcuMetrics system to measure     oxygen on the surface of the eye. Oxygen is important to the health of the cornea. The     proposed instrument will take advantage of phosphorescent dyes that are sensitive to oxygen     concentrations to monitor oxygen concentrations on the surface of the eye. This will have     obvious applications in eye research and contact lens testing.   "
156941|NCT01229475|"     Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure.     Even in experienced centres, repeat interventions are necessary in up to 70 of patients to     achieve sinus rhythm at a long-term follow-up.      While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for the     ablation of paroxysmal and persistent AF ablation, different additional ablation strategies     are used to achieve a modification of the substrate that perpetuates the arrhythmia: linear     lesions (anterior and roof lines) or ablation of complex fractionated atrial electrograms     (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are combined according to the     presenting arrhythmia during procedure.      The aim of the study is to determine whether there is a difference in terms of freedom from     arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient     with recurrence of persistent atrial fibrillation.   "
156948|NCT01229384|"     Hypothesis: That administration of nebulized therapy for bronchiolitis when using positive     airway pressure is superior to standard mask ventilation in reducing hospital admissions.      Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by a variety of     different viruses. It is the most common LRTI in children under 24 months old. Multiple     studies have documented variation in treatment, hospitalization rates, and length of hospital     stay for bronchiolitis, suggesting a lack of consensus and an opportunity to improve care for     this common disorder.      Research to determine optimal delivery methods of respiratory medications that may augment     oxygenation by decreasing atelectasis (Lung cell collapse) and increasing oxygen saturation     have not been done. Currently bronchodilators are delivered through a passive process,     inhaled as they are nebulized (made from liquid into gas) into a face mask. This study will     evaluate whether using a newly developed positive pressure nebulization device that uses     pressure to expand lung cells and, hypothetically, deliver the medication better, improves     oxygenation by reducing atelectasis (lung cell collapse) to decrease hospitalization in     infants with moderate to severe bronchiolitis.      Positive pressure nebulization is a relatively new adaptation of a previously existing     modality, and is already currently in use here at PCH.   "
156949|NCT01229371|"     The purpose of this study is to assess the humoral immune response and safety of the     parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V     using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly     adults, using the EMA (European Medicines Agency) regulation as a guideline.   "
156950|NCT01229358|"     This prospective, multi-institutional randomized clinical trial of a silver ion eluting     dressing material compared to standard dry gauze for closed skin incisions after open     surgical revascularizations for peripheral vascular occlusive disease. Based on the ability     of the silver to lower the bacterial contamination of these vulnerable surgical skin     incisions, the investigators hypothesize that immediate application of Acticoat Absorbent® as     a post-operative dressing will reduce closed incisional wound complications in patients     undergoing lower extremity revascularizations involving infrainguinal skin incisions compared     to standard non-silver eluting dressing material.   "
156951|NCT01229345|"     The purpose of this study is to assess the effect of eating breakfast in combination with     exercise on fat usage, appetite and brain performance later in the day.   "
156952|NCT01229332|"     A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage     forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the     potential clinical effect of ND0611 will be explored in subjects with PD and motor     fluctuations.   "
156953|NCT01229319|"     Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet     radiation exposure. While most authorities consider AK as a pre-malignant lesion, some     consider it as an incipient squamous cell carcinoma (SCC). In addition, the skin around     clinically obvious AK lesions has been subject to the same chronic ultraviolet exposure,     resulting in genetic damage and mutations, resulting in field cancerization. Subclinical     AKs may progress to clinical AKs, or even de novo invasive SCCs.      Among the current therapies for the treatment of AK are excisional surgery, cryosurgery,     electrodessication and curettage, topical chemotherapy and light therapies. With cryotherapy,     treated lesion clearance rates at 3 months post-treatment after double-freeze thaw     cryotherapy has been reported to be around 76-88%; Overall lesion clearance rate at     approximately 5 months post-cryosurgery has been reported to be 35-51%.      Imiquimod is a topical immune response modifier and a 5% formulation has been approved for     the treatment of AKs in the US as a 2x/week for 16 week regimen and in Europe as a 3x/week     for 4 week regimen for 1 or 2 courses of therapy. Topical imiquimod treatment may also reduce     subclinical lesions in the treatment area, resulting in fewer new AK lesions developing     over the same period of time when compared to focal treatment. In a comparison of cryosurgery     versus imiquimod for the treatment of AKs, Krawtchenko et al reported initial complete     clearance rates of 68 and 85% by clinical assessment, respectively. However, the treatment     field sustained clearance rate was 4% versus 73%, respectively. Tan et al reported that while     application of imiquimod or vehicle following cryosurgery resulted in comparable target AK     clearance rates at 12 weeks of 79% versus 76%, respectively, the imiquimod group had fewer     total AKs and fewer subclinical AKs.      Imiquimod cream at a concentration of 3.75% has been found in Phase 3 studies to be superior     to placebo cream with respect to clearance of AKs using a regimen of up to 2 packets (250 mg     of cream per packet, 500 mg total) applied daily to the entire face (approximately 200 cm2)     for two 2-week treatment cycles separated by a 2-week no-treatment period. This study aims to     examine the benefit of cryotherapy in combination with imiquimod 3.75% compared to     cryotherapy alone.   "
156954|NCT01229306|"     Catheter ablation with isolation of the pulmonary veins has proven to be an effective     treatment option in patients with paroxysmal atrial fibrillation. In patients who have a     relapse of paroxysmal atrial fibrillation after one ablation procedure the investigators     compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial     line.   "
156955|NCT01229293|"     This study is conducted at Odense University Hospital(OUH) in collaboration with Institute of     Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical     Institute, University of Southern Denmark      Aim: To evaluate the effect of implant design on postoperative total leg muscle function     recovery and gait in hip replacement patients.      Design: A prospective randomized controlled clinical trial where patients are randomized into     (A) total hip arthroplasty surgery (THA) or (B) resurfacing total hip replacement surgery     (RTHA). Pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks     post-surgery.   "
156956|NCT01229280|"     The proposed study was designed as a randomized two-sequence, two period crossover trial to     assess the bioequivalence, pharmacokinetic profiling and safety of a brand generic     formulation of darifenacin [Darisec(R) 7.5 mg] vs. the innovator [Enablex(R)7.5 mg]in healthy     volunteers in postprandial state.   "
156957|NCT01229267|"     This is a study to determine whether investigational V212 reduces the incidence of herpes     zoster (HZ) compared to placebo when administered to recipients of autologous hematopoietic     cell transplants (HCT).   "
156958|NCT01229254|"     The primary purpose of this study is to optimize drug exposure in the target population.   "
156959|NCT01229241|"     The aim of the study is the assessment of the systemic absorption of local anesthetics during     continuous epidural infusion for postoperative pain control.   "
156960|NCT01229228|"     The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe     and effective for the treatment of dental pain.   "
156961|NCT01229215|"     This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled     study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections     administered monthly or every other month in patients with geographic atrophy.   "
157172|NCT01226459|"     This is a six month clinical trial to evaluate the effectiveness and safety in women with     Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation     applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.   "
156962|NCT01229202|"     Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound     healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the     treatment of eye diseases associated with neovascularization. The purpose of this randomized     study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on     the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and     assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery,     where a small drainage canal is created at the front of the eye, is the most common glaucoma     surgery performed worldwide. The goal of the surgery is to control intraocular pressure.     Failure of this procedure is most commonly caused by excessive scarring of the surgical site.     If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of     surgery, wound healing may be slowed and surgical failure prevented.      The results of this study will be helpful in the future development of new more effective and     safe surgical techniques for treatment of glaucoma.      Patients who have given informed consent are randomized into two groups. One group receives     standard of care for trabeculectomy surgery and the other group receives standard of care     plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection     of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are     seen by their study doctor six times in the following year. At these visits measurements are     taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical     exam and at months six and twelve photographs of the patients' eye are taken.   "
156963|NCT01229189|"     Vitamin D deficiency is wide spread in South Asian population and is contributing to burden     of disease in this region including Pakistan. The relative importance of vitamin D     deficiency, mutation in its receptor and maternal and child health has not been established     in Pakistan and population based studies are required to explore and avert the maternal and     Neonatal complications and consequences of Vitamin D deficiency      The trial will evaluate the effectiveness of Vitamin D supplementation to pregnant women and     their Infants. It will be a double blind placebo controlled trial, which will be conducted in     a rural district of Pakistan.   "
156964|NCT01229176|"     This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the     Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is     highly endemic and an efficacious vaccine against this disease is very much needed.   "
156965|NCT01229163|"     Background:      - Treatment outcomes for substance abuse are improved by regular attendance at counseling     sessions, and attending at counseling sessions can be futher improved by prize-based     incentives. However, a system of prize-based incentives can be difficult to administer     without computerization for accurate recordkeeping and rapid calculation of earnings. NIDA     researchers have developed the eXtensible Platform for Motivational Incentives (XPMI), a     computer program that for reinforcement of weekly counseling attendance. Users are eligible     to win prizes through automated draws. The researchers are interested in testing the     effectiveness and ease of use of the XPMI software so it can ultimately be run by staff in     community treatment programs.      Objectives:        -  To test the XPMI program in a clinic setting, with emphasis on its functionality,          usability, and acceptability for counselors.        -  To test and validate XPMI s accuracy in calculating incentives to reinforce drug          abstinence.      Eligibility:      - Individuals at least 18 years of age who are participating in clinical trials for treatment     of heroin dependence in an outpatient treatment-research program, and have at least 14 weeks     remaining in the program.      Design:        -  Participants will meet with their counselors as regularly scheduled. Twelve of the          visits will count toward this study, with 2 extra weeks in case of counselor absence or          clinic closure.        -  Participants will receive an incentive in the form of a prize draw for arriving to          counseling appointments on time, on the scheduled day. (Participants may reschedule one          appointment per week without losing the chance for a prize draw.) For each consecutive          appointment attended on time, participants will receive extra prize draws; attending          three counseling appointments in a row can earn four bonus prize draws.        -  To draw for prizes, participants will push a button on a computer. Each prize draw could          result in a small prize worth $1 to $2, a large prize worth $20, a jumbo prize worth          $100, or no prize at all. The average prize total per person is expected to be about          $378.        -  Participants will also be asked to fill out questionnaires about the computer program.   "
156966|NCT01229150|"     Background:      AZD6244 (ARRY-142886) is an investigational anticancer drug that is designed to block a     critical component (MEK (methyl ethyl ketone)) of a pathway (MAP (mitogen-activated protein)     kinase pathway) that causes some lung cancer cells to grow. The MAP kinase pathway could be     overactive in a proportion of lung cancers, including some which also have another mutation     in a protein known as KRAS (Kirsten rat sarcoma viral oncogene homolog). Approximately 20% of     lung cancers have KRAS mutations which can make some cancer treatments including erlotinib, a     standard anticancer treatment drug less effective. Researchers are interested in determining     whether AZD6244 is effective in treating advanced NSCLC (non small cell lung cancer),     including KRAS mutated lung cancer that has not responded to standard therapy.      Objectives:      To determine the effectiveness of AZD6244, either alone or in combination with erlotinib, in     preventing tumor growth in individuals with NSCLC.      Eligibility:      Individuals at least 18 years of age who have been diagnosed with advanced NSCLC that has not     responded to standard therapy.      Design:        -  Participants will be screened with a medical history, physical examination, blood tests,          imaging studies, and potentially, tumor biopsy tests to determine whether a          participant's NSCLC contains mutations in the KRAS protein.        -  Participants will be divided into two groups based on the status of the KRAS protein in          their NSCLC tumor cells:        -  Individuals with normal KRAS protein: Half will receive AZD6244 and erlotinib, and half          will receive only erlotinib.        -  Individuals with mutated KRAS protein: Half will receive AZD6244 and erlotinib, and half          will receive only AZD6244.        -  Participants will take their assigned medications daily (on an empty stomach in the          morning and/or evening, depending on the treatment) for 28-day cycles of treatment.          Participants will also keep a medication diary to record any side effects.        -  Participants will have frequent blood tests during the first cycle of treatment, and          will have imaging studies or other tests as required by the study researchers.          Participants may also have an additional tumor biopsy after the end of the first          treatment cycle.        -  Treatment will continue until the disease progresses, significant side effects develop,          the participant chooses to leave the study, or the researchers end the study....   "
156967|NCT01229137|"     Assessment of sensor parameter in patients with heart failure.   "
156968|NCT01229124|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in RNA and identify biomarkers related to cancer.      PURPOSE: This research study is studying RNA biomarkers in tissue samples from infants with     acute myeloid leukemia.   "
156969|NCT01229111|"     This phase II trial is studying how well giving cediranib maleate together with combination     chemotherapy works in treating patients with advanced biliary cancers. Cediranib maleate may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by     blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, leucovorin     calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving cediranib maleate together     with combination chemotherapy may kill more tumor cells.   "
156970|NCT01229098|"     The purpose of this study is to evaluate the effect of once daily use of LEO 80185 gel on the     hypothalamic-pituitary-adrenal (HPA) axis and calcium metabolism in subjects with extensive     psoriasis vulgaris.   "
156971|NCT01229085|"     To evaluate the efficacy of the combination of mometasone furoate 0.1% and Salicylic Acid 5%     in patients of both sexes who presented clinical symptoms of psoriasis of mild to moderate.   "
157466|NCT01222871|"     The purpose of this study is to compare the effectiveness of intranasal Triamcinolone     delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked     dressing, in the treatment and prevention of early nasal polyposis.   "
156972|NCT01229072|"     The Heparin form a complex with a plasma protein, antithrombin III (ATIII), which is an     endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its     destruction. Moreover, heparin and other proteases ATIII inactivate the clotting cascade,     especially the anti-activated factor X. The end result of these actions is the inhibition of     biochemical training and synthesis of certain clotting factors that activators of critical     functions in the genesis of a blood clot. Patients with chronic renal failure (CRF) who use     the treatment of hemodialysis need a system of anticoagulation with the direct thrombin     inhibitor and / or heparinóides to prevent thrombosis.      Based on clinical studies, to control the level of plasma heparin in patients with CRF is     essential. Evidence of clotting as APTT, TP, ACT and proof of the activity of anti-factor Xa     should be used as a substrate of protection for those patients on hemodialysis.   "
156973|NCT01229059|"     This study aims to explore time-dependent effects of lipid infusion an intramyocellular lipid     metabolites and the induction of impaired insulin signaling.   "
156974|NCT01229046|"     This study will evaluate the safety, tolerability and PK of ticarcillin-clavulanate in     infants <91 days of age with suspected systemic infection.   "
156975|NCT01229033|"     Catheter ablation has proven to be an effective treatment option in patients suffering from     symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major     steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and (2)     modification of left atrial and eventually right atrial substrate by ablation of complex     fractionated atrial electrograms (CFAE). CFAE are mainly found at the ostia of the pulmonary     veins, around the left atrial appendage, at the mitral annulus and the septum.      When ablating CFAE 40-65% of the patients show a regularization of AF to an atrial     tachycardia (AT) that can be macro- or micro-reentrant (localized re-entry). Until now the     significance of the AT is unclear.      In the following study we examine the hypothesis that an ablation of AT occuring during CFAE     ablation (group 1) significantly improves outcome defined as freedom of atrial arrhythmia (AF     or AT) compared to patients that are cardioverted when AF has regularized to AT (group 2).   "
156976|NCT01229020|"     Assessment of regional contribution of different areas of the lung to its integrated function     is often required, such as prior to lung resection in the presence of tumor or emphysema.     This assessment is derived from the proportion of zonal radionuclear perfusion or     ventilation. The investigators hypothesized that lung VRI may provide an alternative approach     to assess regional lung function.   "
156977|NCT01229007|"     The objective of this study is to assess the efficacy and safety of a Von Willebrand     Factor/Factor VIII (VWF/FVIII), Biostate, and to investigate the pharmacokinetics of Biostate     in children with haemophilia A.   "
156978|NCT01228994|"     The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers,     baclofen will be superior to placebo for smoking abstinence measures.      The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher     rates of medication compliance (i.e. take the medication as directed for the trial period)     than those in the placebo group.      The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco     withdrawal and craving ratings as compared to placebo.   "
156979|NCT01228981|"     The purpose of this study is to characterize type 2 diabetic patients with initial     alterations of diabetic retinopathy (DR) based on 3 different phenotypes previously     identified and different patterns of progression in order to correlate this data with genetic     information.   "
156980|NCT01228968|"     Subjects will undergo a brief magnetic resonance (MRI) scan. The resulting images will be     used to compare two abdominal fat segmentation techniques. The first technique is already     validated and in use. The second technique was recently developed and has not been validated.     The hypothesis is that the second technique will be the faster and more reliable of the two.   "
156981|NCT01228955|"     Impaired health related quality of life (HRQOL) including fatigue, problems with sleep and     psychosocial well being (physical, emotional, and spiritual) have been noted in adult cancer     survivors. Physical domain is one of the most common measured indicators of HRQOL. Despite     the tremendous implications of having an impaired QOL, few studies have staged interventions     aimed at improving HRQOL in a heterogeneous group of cancer survivors. There is little     literature examining whether a yoga intervention is feasible in a heterogeneous group of     cancer survivors.      The proposed research will utilize Vanderbilt Ingram Cancer Center (VICC), Nashville General     Hospital (NGH) and REACH for Survivorship program for a pilot study. The investigators will     see if a study using a broad range of diagnoses is feasible for a Yoga Intervention.   "
156982|NCT01228942|"     The purpose of this study is to determine if the COXEN algorithm, using the diagnostic device     Affymetrix GeneChip, is able to predict which chemotherapies will be best for treatment of     recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.   "
156983|NCT01228929|"     Objectively evaluate the ocular surface (pre-corneal tear film) of individuals prior to and     after an intervention (such as a dry eye treatment, environmental change, artificial tear     use, or contact lens wear) in a controlled-environmental chamber, over time using non-contact     instruments.   "
156984|NCT01228916|"     Tobacco use and tobacco-caused illnesses and death are increasing in developing countries     globally, so it is critical to study these countries in order to effectively address the     tobacco epidemic. The proposed project will test the effectiveness of community-based     interventions for secondhand smoke and quitting smoking in eight underserved communities in     the Dominican Republic. The project will also partner with communities and national and     international groups to determine whether the methods and interventions from this study in     the Dominican Republic can also be used to help other countries in the region and underserved     groups in the United States.   "
156985|NCT01228903|"     This study will test the hypothesis that uric acid impairs the function of vessels in     patients with kidney disease   "
157028|NCT01228344|"     The purpose of this study is to describe the pediatric and adult patients (U.S. and foreign     residents) diagnosed with malaria and treated with artemether-lumefantrine with regard to     their demographics, including evaluation of their malaria immune status, treatment     effectiveness, prior and concomitant medication use, and the occurrence of adverse events in     association with artemether-lumefantrine treatment, based on the information collected in the     CDC Malaria Case Surveillance Report Form.   "
156986|NCT01228890|"     In this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the     CATCH-IT primary care/Internet based depression prevention intervention against Attention     Monitoring Psychoeducation (AMPE) in preventing the onset of depressive episodes in an     intermediate to high risk group of adolescents aged 13-17. We plan to (a) identify high risk     adolescents based on elevated scores on the PHQ-A, a screening measure of depressive     symptoms; (b) recruit 400 (200 per site) of these at-risk adolescents to be randomized into     either the CATCH-IT or the AMPE group; (c) assess outcomes at 2, 8, 12, 18, and 24 months     post intake on measures of depressive symptoms, depressive diagnoses, other mental disorders,     and on measures of role impairment in education, quality of life, attainment of educational     milestones, and family functioning; and (d) conduct exploratory analyses to examine the     effectiveness of this intervention program, moderators of protection, and potential ethnic     and cultural differences in intervention response.   "
156987|NCT01228877|"     Performing adduction and abduction resistance exercise will increase hip bone density and     strength to a greater extent than doing squat and deadlift exercise.      Aim #1: To determine if doing hip adduction and abduction resistance exercise training for 16     weeks improves spine bone mineral density and hip bone mineral density and strength as     determined by finite element modeling.      Aim #2: To compare the effects of hip adduction and abduction exercise to squat and deadlift     exercise with respect to potential changes in hip bone mineral density and strength.      Aim #3: To determine if the addition of adduction and abduction exercise to squat and     deadlift exercise promotes an additive effect with respect to changes in spine bone mineral     density and hip bone mineral density and bone strength.   "
156988|NCT01228864|"     The Brody belt may help improve quality of life in patients using urinary drainage bags.     PURPOSE: This clinical trial studies the Brody belt in improving the quality of life in     patients using urinary drainage bags.   "
156989|NCT01228851|"     The purpose of this study is to assess the facilitation of balance in Parkinson's disease     (PD) patients using the Nintendo Wii fit, with the ultimate goal of developing a program for     function and fitness in this patient population. In this study, PD patients will participate     in group exercise classes using the Wii Fit and the effects on balance, postural sway, and     quality of life assessed.   "
156990|NCT01228838|"     The purpose of this study is to assess the efficacy, safety and tolerability of NGX-1998     applied for 5 minutes for the treatment of postherpetic neuralgia (PHN).   "
156991|NCT01228825|"     Infection, especially mediastinitis, is major complication in cardiac surgery. Considering     that cardiopulmonary bypass (CPB) can alter kinetics of drugs, including antibiotics, the aim     of this study was to evaluate the influence of cardiopulmonary bypass ( CPB) on plasma     concentrations and pharmacokinetics of cefuroxime, administered prophylactically, in a 1.5g     dose, followed by three bolus of 750mg every 6 hours, for 24 hours, in 19 patients undergoing     coronary artery bypass graft (CABG) with CPB (CPB Group, n = 10), or without CPB (Off-Pump     Group, n = 9); and assess whether the proposed dosing regimen is adequate to maintain plasma     concentrations above 16 g/L (4 times the MIC) for the first 24 hours after the beginning of     surgery.   "
156992|NCT01228812|"     The purpose of the study is to compare physical activity behaviour of rheumatoid arthritis     patients with healthy matched controls.   "
156993|NCT01228799|"     Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one     operation is superior to the other. Both procedures are performed in patients with medically     uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure,     which showed encouraging results without antimetabolite usage intra- and postoperatively.     Purpose of the study is to compare both surgeries concerning success rate, intraocular     pressure, medication and complications. So far there is no comparison of the standard     procedure trabeculectomy and the new approach, canaloplasty available.   "
156994|NCT01228786|"     The present study is designed to examine the expression of VDR, CaSR, PTH, Cyclin D1, Ki67     and PCNA and to find out its relationship with clinical parameters in parathyroid adenomas.     Examination of the contribution of genes expression can elucidate the critical link between     proliferation and functional abnormalities in parathyroid adenomas. Alternative to DNA and     RNA, protein expression can provide a better understanding of this disease.   "
156995|NCT01228773|"     The objective of this study is        1. to develop a web-based, tailored program for Cancer-related fatigue in cancer survivors,          which is comprehensive and evidence-based,        2. to evaluate the efficacy for cancer-related fatigue as a result of participating in the          Web based, tailored program(Health Navigation®) for 12 weeks        3. to evaluate the efficacy for quality of life, fatigue-related behavior, satisfaction          with the treatment as a result of participating in the Web based, tailored          program(health navigation®) for 12 weeks        4. to assess the efficacy of such intervention compared with usual care in cancer survivors   "
156996|NCT01228760|"     The purpose of this dose escalation study is to determine the Maximum Tolerated Dose (MTD)     and the recommended Phase 2 dose of ASG-5ME in subjects with castration-resistant prostate     cancer (CRPC).   "
156997|NCT01228747|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of     levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients     aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with     1 or 2 anti-epileptic drugs.   "
156998|NCT01228734|"     The purpose of this study is to assess whether the progression free survival (PFS) time with     FOLFOX-4 plus cetuximab is longer than that with FOLFOX-4 alone as first-line treatment for     mCRC in Chinese subjects with RAS wild-type tumors.   "
156999|NCT01228721|"     PURPOSE. To evaluate the impact of self-acting eyetracking and retest software on the     reproducibility of retinal nerve fiber layer (RNFL) thickness measurements in glaucoma     patients and healthy control subjects using Spectralis® SD-OCT.      METHODS. RNFL thickness was measured in 56 normal and 47 glaucomatous eyes by one operator     within one session with a brief rest between measurements. Three measurements were taken with     the eye-tracker and retest function, and three were taken without this function, alternating     between measurement methods.        -  Trial with medical device   "
157266|NCT01225211|"     The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and     pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with     ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the     F508del-CFTR mutation.   "
157000|NCT01228708|"     Aims:      To design a proactive implementation strategy for a chronic-disease-management-programme.      To describe effects of the active implementation of a programme for COPD-patients measured on     patient-related goals and use of health resources.      To describe stakeholders' evaluation of the implementation.      Materials and method:      An intervention study with 3000 COPD-patients cluster-randomized after a bloc-randomization     of their GP-practice. 18 GP-practices in Ringkøbing-Skjern-Municipality are randomized to     receive an active implementation or to an as usual group. A neighboring municipality acts     as sleeping control. With data from registers and a questionnaire-survey the effect on     COPD-patients self reported-health, evaluation of health system and changes in distribution     of health resources is analyzed. How health professionals perceive the implementation and how     it influences their conception, interactions and culture is illustrated by interviews with     stakeholders.      We expect to see improved health related quality of life, enhanced evaluation of the health     system and a more appropriate distribution of health resources in the intervention group.   "
157001|NCT01228695|"     Weight gain is both a significant risk factor for obstructive sleep apnea and a side-effect     of long-term systemic steroids therapy.      This study aimed to investigate the impact of long-term systemic steroid treatment on sleep     apnea.   "
157002|NCT01228682|"     A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns     of Samsca in routine medical practice.      A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca     when used in a real-life setting.   "
157003|NCT01228669|"     This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate     the safety, pharmacokinetics (how the trial drug is distributed in the body) and     pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021     administered intravenously and subcutaneously to healthy male subjects and subjects with     haemophilia A or B   "
157004|NCT01228656|"     The aims is to evaluate the efficacy and comparative isolation of the association Mometasone     furoate + Salicylic Acid and the substance isolated Mometasone furoate produced by the     Laboratory Glenmark Pharmaceuticals Ltd. in patients of both sexes, patients with plaque     psoriasis grade mild to moderate.   "
157005|NCT01228643|"     Prove the efficacy of pancreatic enzyme Norzyme ® imported by Pharmaceutical Chemistry     Laboratory Bergamo Ltda. verified by activity lipase contained in the formulation in     controlling steatorrhea in 16 patients of both sexes aged 14 to 65 years, patients with     pancreatic insufficiency Exogenous any cause. It's effectiveness will be found in a study     randomized, crossover, comparative biosimilar product produced by Creon ® Laboratory Solvay     Farma Ltda.   "
157006|NCT01228630|"     The loratadine-pseudoephedrine combination has proven to be more effective than the use of     these individual components. This prospective, randomized, double-blind and paralel study, in     which patients with perennial allergic rhinitis receive one of loratadine + pseudoephedrine     association drug for treatment of signs and symptoms during 4 weeks.   "
157007|NCT01228617|"     This is an explorative study comparing new prototypes of Nicotine Replacement Products with     Nicorette® gum.   "
157008|NCT01228604|"     This study is an open-label, 6 month trial, of immediate release methylphenidate (MPH-IR) for     children with ADHD aimed at assessing whether the observable behavioral changes seen during     treatment are associated with potentially more stable underlying modifications in brain     functioning (resting-state functional connectivity). Additionally, we will also be looking at     treatment effects on neuropsychological processes and reading skills. This information will     contribute to the first Brazilian study assessing the cost-effectiveness of the treatment of     ADHD. Children with ADHD will be compared to a sample of sex and age-matched sample of     typically developing children.   "
157009|NCT01228591|"     The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses     against ACUVUE® ADVANCE® lenses in the plus power parameters.   "
157010|NCT01228578|"     The investigators are conducting a double-blind, placebo controlled,randomized trial of     multivitamin supplements(containing B-vitamins, C, and E) to determine their efficacy in     slowing disease progression, indicated by increased CD4 count, weight gain, and improved     quality of life, and decreased morbidity, mortality, and drug-related adverse events (i.e.     peripheral neuropathy, anemia, and diarrhea).      The investigators hypothesize that daily multivitamin supplementation will: (1) improve     immune reconstitution; (2) improve weight gain, and (3) improve quality of life.   "
157011|NCT01228565|"     The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC     V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving     radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.   "
157012|NCT01228552|"     The purpose of this study is to evaluate the efficacy and safety of intra-oral topical     ketoprofen for the treatment of acute migraine.   "
157013|NCT01228539|"     The study will compare the efficacy of Trauma Affect Regulation: Guide for Education and     Therapy (TARGET) vs. the best validated psychotherapy for adults with posttraumatic stress     disorder (PTSD), Prolonged Exposure (PE). Male military personnel and veterans suffering with     PTSD and problems with anger after returning from military service in Afghanistan (Operation     Emerging Freedom, OEF) and/or Iraq (Operation Iraqi Freedom, OIF) will be participants. The     goal is to determine if a present-centered psychotherapy that teaches skills for emotion     regulation and does not require re-telling of traumatic memories is as efficacious as the     trauma memory-focused PE psychotherapy.   "
157014|NCT01228526|"     To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without     significantly compromised arterial circulation.   "
157015|NCT01228513|"     The purpose of this study is to evaluate the efficacy and safety of three concentrations of a     development drug compared to placebo in the treatment of atopic dermatitis.   "
157016|NCT01228500|"     The primary aim of this study proposal is to test an innovative form of fetal bovine dermis     bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound     healing in diabetic foot ulcers.   "
157173|NCT01226446|"     Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The     investigators hypothesize that the correction of hypovitaminosis D before the initiation of     anti-HCV combination therapy and the maintenance of an optimal vitamin D status during     antiviral therapy could improve the antiviral efficacy   "
157017|NCT01228487|"     The important role of mechanical joint stress for the insert and progress of osteoarthritis     (OA) is supported by recent studies. The degeneration of joint cartilage is caused either by     unphysiological load of a healthy joint or physiological load of a damaged joint. The exact     mechanisms leading from increased weight bearing and overuse to cartilage degeneration are     mostly unknown.      The hypothesis of the study is that parameters of oxidative stress in the joint synovial     space reflect damages possibly leading to OA. These parameters correlate with parameters of     oxidative stress in the peripheral blood. Aim of the study is the identification of such non-     invasive obtainable biomarkers which represent the degenerative and regenerative changes in     joint.   "
157018|NCT01228474|"     Experimental study to assess the efficacy of single embryo transfer (SET) with respect to     double embryo transfer (DET) in an oocyte donation programme, 160 recipients will be     randomized in two groups   "
157019|NCT01228461|"     Fatigue is one of the most prevalent symptoms endorsed by cancer survivors, particularly     those treated for breast cancer or Hodgkin lymphoma. Despite the tremendous implications such     work has for effective interventions, little is known about the underlying pathophysiology of     fatigue, association with medical co-morbidities and factors that may help predict those to     be at highest risk.      The proposed research will utilize Vanderbilt-Ingram Cancer Center REACH for Survivorship     Program together with the investigators Hematologic Malignancies Program. In adolescent and     young adults (AYA), ages 18 - 39 the investigators will address the following:      Primary Aims Aim 1: Assess the prevalence and severity of fatigue and its impact on     functional outcomes Aim 2: Determine host, disease and treatment-related risk factors for     fatigue      Secondary Aims Aim 1: Evaluate the association between levels of proinflammatory cytokine     activity and fatigue Aim 2: Evaluate the association between fatigue and self reported     fatigue in AYA Hodgkin lymphoma (HL) survivors.      Hypotheses:        1. Fatigue is more prevalent and severe among AYA HL patients and survivors, compared to          general population and will be associated with impaired functional outcome.        2. Risk factors for fatigue include higher disease stage, B symptoms and elevated          erythrocyte sedimentation rate at diagnosis, dose density of chemotherapy and higher          doses and more expanded fields of radiotherapy.        3. Risk of fatigue is associated with long-term cardiopulmonary and endocrine          complications.        4. Levels of specified proinflammatory cytokines are associated with increased fatigue.   "
157020|NCT01228448|"     The investigational part of this study is using a mobile PET/CT scanner to take images of the     participants tumor immediately after they are treated with proton radiation. This allows the     participant to be treated and imaged on the same bed. The information obtained may improve     the accuracy of treatment and may help to minimize the dose delivered unnecessarily to     healthy tissue.   "
157021|NCT01228435|"     IPI-504 blocks a protein that is in cancer cells and is also in normal cells. This protein is     called Heat Shock Protein-90 (Hsp90). Hsp90 helps protect certain other proteins from being     destroyed by cells. These proteins can mutate to give off signals that allow cancer cells to     keep growing. By blocking the function of Hsp90, we hope that the cancer cell will block the     mutated protein and cause the cancer cells to die. This drug have been used in other research     studies and in the laboratory and information from those other research studies suggests that     thsi drug may help to treat lung cancer with ALK mutations. In this research study, we are     looking to see what effects IPI-504 has in patients with lung cancer who have an ALK     mutation.   "
157022|NCT01228422|"     The aim was to verify the Pharmacokinetics and Pharmacodynamics of alpha interferon     product-2A - Blausiegel, taking as the comparator drug product Roferon ® A (interferon     alpha-2A - Roche Laboratory).   "
157023|NCT01228409|"     Psoriasis is a chronic skin disorder with a prevalence of approximately 1-3% worldwide. At     present, there is no curative therapy available and the clinical course is unpredictable, but     in the majority of cases psoriasis is a chronically remitting and relapsing disease. Several     clinical subtypes of psoriasis exist with differences in manifestations and skin areas     involved.      Chronic stable plaque psoriasis (Psoriasis Vulgaris) is the commonest form of the disease,     accounting for 85-90% of cases. The circumscribed infiltrated skin lesions are scaly and     erythematous and often symmetrically distributed over the body. Several types of palliative     therapies exist. The therapies are either topical or systemic. The severity of chronic plaque     psoriasis is often determined by the percentage of body surface area (BSA) involved. For     mild, moderate and severe chronic plaque psoriasis with BSA involvement of up to 20%, initial     therapy is topical. Phototherapy and numerous systemic therapies are usually indicated when     more than 20% of skin is affected.      Severe plaque-type psoriasis requires systemic and long-term therapy in order to induce and     maintain remission. Acitretin 25mg/day combined with a phototherapy regimen is a standard     treatment that provides clinically significant efficacy, however many patients experience     tolerability issues due to retinoid-related adverse events. Retinoid-related adverse events     include but are not limited to: alopecia, dry mucus membranes, pruritus, photosensitivity,     elevation of liver enzymes, elevation of serum triglycerides, cholesterol and decrease of     HDL, arthralgias, myalgias, eye irritation, blepharitis, photophobia, conjunctivitis,     headaches, nausea, anemia and leukemia. Reducing the acitretin dose from 25mg/day to     17.5mg/day may provide improved tolerability without compromising efficacy.      The purpose of this study is to ascertain if reducing the acitretin dose from 25mg/day to     17.5mg/day will provide improved tolerability without compromising efficacy.   "
157024|NCT01228396|"     Patients with marked bladder dysfunction as a result of secondary progressive multiple     sclerosis are being recruited to receive AIMSPRO or placebo by subcutaneous injection, in     this double-blind crossover study.   "
157025|NCT01228383|"     Study design:      Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184     + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs.     placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center     study      Study objectives:      Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects.      Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate     the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To     evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or     placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo     in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the     monoclonal antibodies (mAbs).   "
157026|NCT01228370|"     Because the bladder neck and proximal urethra contain abundant α1-adrenergic receptors,     α-blockers or α1-blockers are well-known to reduce bladder neck obstruction in patients with     or without neurogenic bladder.      α1-blockers seem to have a potential to reduce bladder outlet resistance during voiding in     patients with neurogenic bladder.      Based on these turnouts, we designed this clinical study to evaluate the clinical effect and     safety of silodosin on voiding dysfunction associated with neurogenic bladder.   "
157029|NCT01228331|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than once     drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses     high-energy x-rays to kill cancer cells. It is not yet known whether giving clofarabine or     high-dose cytarabine, pegaspargase, and combination chemotherapy followed by daunorubicin     hydrochloride or doxorubicin hydrochloride is more effective in treating young patients with     acute lymphoblastic leukemia.      PURPOSE: This randomized phase II/III trial is studying the side effects of giving     clofarabine compared with giving high-dose cytarabine, pegaspargase, and combination     chemotherapy followed by daunorubicin hydrochloride or doxorubicin hydrochloride and to see     how well it works in treating young patients with T-cell acute lymphoblastic leukemia or     precursor B-cell acute lymphoblastic leukemia.   "
157030|NCT01228318|"     With the increasing age of people living with HIV/AIDS, age-induced osteoporosis is likely to     be compounded by HIV/AIDS and HAART-associated bone loss. Mechanistically, osteoclasts the     cells responsible for bone resorption form under the influence of the key osteoclastogenic     cytokine Receptor- Activator of NF-KB (RANKL). The osteoclastogenic and proresorptive     activities of RANKL are moderated by its physiological decoy receptor osteoprotegerin (OPG).     Imbalance in the ratio of RANKL to OPG alters osteoclastic bone resorption and lead to     osteoporosis. Activated T- and B-cells are a major source of RANKL, while normal     physiological B-cells are a major source of OPG. T-cells regulate the production of OPG by     B-cells. Thus changes in the immune system induced by HIV/AIDS and/or by HAART could affect     B-cell and T-cells RANKL and OPG production. Indeed, data from our group shows that in an     animal model of HIV/AIDS, the HIV-1 Transgenic rat, the development of osteoporosis is     recapitulated as observed in HIV-infected patients, and B-cell OPG and RANKL production are     concurrently down regulated and upregulated respectively. Furthermore, preliminary data in     HIV-infected subjects suggests dramatic acute upswing in bone resorption following HAART     initiation that peaks at 12 weeks and then declines. Based on these findings, the     investigators hypothesize HAART associated bone loss is driven by immune reconstitution.     Because this effect of HAART is dramatic in magnitude but short in duration, the     investigators propose to apply antiresorptive agent (zoledronic acid, reclast®) to     specifically spare patients from this dramatic but acute bone damage.   "
157031|NCT01228305|"     The current proposal tests the central hypothesis that acetaminophen will attenuate the     oxidative stress response associated with cardiopulmonary bypass (CPB)-induced hemolysis in     children undergoing cardiac surgery.   "
157032|NCT01228292|"     The purpose of this study is to compare the feasibility, safety and efficacy of hemodialysis     with unfractionated heparin compared to hemodialysis with Citrasate in Critically Ill     Patients.   "
157033|NCT01228279|"     Hypothesis:      Patients starting peritoneal dialysis with a glucose-based regimen have high sympathetic     activity in response to an increase in leptin and insulin. Converting patients from a regimen     of only glucose containing dialysate to a regimen with non-glucose-based solution,     icodextrin, will reduce the insulin and leptin levels and will reverse dialysis-induced     increases in sympathetic activity.   "
157034|NCT01228266|"     The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate     the safety and tolerability of autologous mesenchymal stem cell transplantation in patients     with active multiple sclerosis   "
157035|NCT01228253|"     This preliminary study will examine the differential effects of rTMS on the recall of     extinction of conditioned fear in patients suffering from PTSD (post-traumatic stress     disorder ) compared with subjects without PTSD but with high risk of relapse.   "
157036|NCT01228240|"     Background: Metformin is usually using for glycemic control in type 2 diabetes mellitus.     Different pharmaceutical types of metformin are available. As a clinical trial, we compared     the efficacy and complications of metformin produced by Pars Mino pharmaceutical company,     Iran with Apotex pharmaceutical company, Canada, in type 2 diabetic patients.      Method: 18 eligible women with type 2 diabetes were given metformin Pars Mino or Apotex     (500 mg twice a day) each for 6 weeks period in a randomized, double blind, crossover study.     After 2 weeks washout period another 6 weeks period with another Brand of metformin was     prescribed. FBS, HbA1C, lipid profile (Cholesterol, TG, HDL, and LDL), weight, and BMI were     assessed before and after each treatment phase. The results were compared with each other by     paired sample T-test, Independent sample T-test.   "
157037|NCT01228227|"     An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after     otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch     occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after     PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing     obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent     studies have suggested that pretreatment with Atorvastatin may be associated with a reduction     in infarct size after elective PCI. (5-7 ). Actually the standard pretreatment in patients     undergoing elective coronary-PCI and already treated with aspirin is clopidogrel loading dose     administration before procedure.(8,9)The investigators compared a high (80mg) re-loading dose     of Atorvastatin with a high loading dose of Rosuvastatin (40 mg) both administered within 24h     before the procedure in reducing the rate of periprocedural MI. Therefore, the investigators     will conduct a single center, prospective randomized study to assess whether a single, high     (80mg) loading (within 24h)dose of Atorvastatin compared with a single loading dose of     Rosuvastatin (20 mg) is effective in preventing elevation of biomarkers of MI after elective     coronary stent implantation. We evaluate the incidence of MACCE(occurring of cardiac death,     myocardial infarction (including periprocedural myonecrosis) and stroke at 30 days 6 and 12     month follow-up.   "
157052|NCT01228032|"     There is an urgent need to develop practical, sustainable approaches to improving medical     care for persons treated in community mental health settings. This study will test a novel     approach for improving mental health consumers based on a partnership model between a     Community Mental Health Center and a Community Health Center. When this study is completed,     it will provide a model for a medical home for persons with severe mental illness that is     clinically robust, and organizationally and financially sustainable   "
157053|NCT01228019|"     This survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant     (TREDAPTIVE) in usual practice in Korea according to the new product re-examination     regulations of the Korean Food and Drug Administration.   "
157038|NCT01228214|"     Treatment of coronary artery disease is a major health care problem across the entire word,     and the United States. Unfortunately, despite a number of medical advances, diagnostic     procedure, or epidemiological studies, the treatment of these patients remain complex, and     and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United     States and Canada documented that drug treatment, coronary interventions or both were not     effective solution in coronary artery diseases.      A novel approach has recently been developed, based on the critical role of the potassium (K)     content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by hemoglobin     (red-blood-cell) occurs simultaneously in blood passing through the lungs, whereas in the     organs as the heart, the hemoglobin release both Oxygen and K ions.      This apparently simple mechanisms occurs in human blood in all individuals but could be     altered in subjects with acquired or hereditable defect in red-blood-cell K content, as in     hypertensives or CAD patients.   "
157039|NCT01228201|"     The purpose of this study is to examine the effect of two different physical exercise     protocols on changes in coronary artery plaque composition and development of in-stent     restenosis in patients treated with percutaneous coronary intervention with stent     implantation. The investigators will compare aerobic interval training and moderate     continuous training. Both exercise protocols have a duration of 12 weeks. The investigators     hypothesize that aerobic interval training is superior to moderate continuous training     regarding effects on the composition of coronary artery plaques and a reduction in the     development of in-stent restenosis.   "
157040|NCT01228188|"     The purpose of this study is to evaluate the efficacy and safety of surgical treatment of     FTMH using an inverted ILM repositioning to improve anatomical and functional outcomes in     patients with a macular hole.   "
157041|NCT01228175|"     The study will test genetic factors that may predict the effectiveness of varenicline.   "
157042|NCT01228162|"     The researchers want to investigate the effects of muscle relaxation with rocuronium bromide     during general anaesthesia on muscle trauma (serum CK, CRP) and postoperative analgesic     consumption in patients with total hip prosthesis replacement (general vs. spinal     anaesthesia).   "
157043|NCT01228149|"     The most common cause of post-trabeculectomy filtration failure is postoperative scarring.     Long-term preoperative treatment with local antiglaucoma agents containing preservatives has     an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons     prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs,     controlling IOP with oral acetazolamide, and treating the eye with local steroids.      Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP     preoperatively with the aim of avoiding postoperative excessive scarring and the known     adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term     outcomes.      This study will investigate comparability (non-inferiority) of medical benefits of two     different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing     COSOPT-S® bid to oral acetazolamide plus dexamethasone.   "
157044|NCT01228136|"     The purpose of this study is to determine if the use of tranexamic acid prior     adenotonsillectomy in children can reduce surgical and postoperative bleeding.   "
157045|NCT01228123|"     The mortality of acute renal failure (ARF) remains to be high (around 60-70%) despite     manifold improvements in ICU care. At present, it is not clear if the method chosen for renal     replacement therapy, i.e. intermittent haemodialysis (IHD) or continuous haemofiltration     (CVVH), might impact on the outcome of these patients. For this purpose, a prospective     randomised clinical study of the effect of continuous versus intermittent renal replacement     therapy on the mortality and outcome of acute renal failure will be performed.   "
157046|NCT01228110|"     Low dose hydrocortisone IV in patients with CAP fastens recovery of pneumonia and prevents     the development of sepsis related complications with a significant reduction in duration of     mechanical ventilation   "
157047|NCT01228097|"     This study will compare brain and hormone responses to food images (and food) in women who     undergo: (1) gastric bypass surgery; (2) principally restrictive surgery (laparoscopic     adjustable gastric banding or laparoscopic sleeve gastrectomy); or (3) no weight loss     surgery, with the intent of remaining relatively weight stable (within 10-15 lb of your     present weight). The investigators will use magnetic resonance imaging (MRI) to see how the     brain responds to pictures of food and to consuming a liquid meal replacement. The     investigators wish to determine whether the two surgeries have different effects on appetite,     as observable in the brain, and whether the possible effects on appetite differ from those in     participants who have a similar body weight but remain relatively weight stable. The     investigators also will draw blood to determine how hunger and fullness hormones change     after eating and to see if there are any differences among the three groups. The study is     being sponsored by the National Institutes of Health (NIH).   "
157048|NCT01228084|"     This phase II trial studies how well sulforaphane works in treating patients with recurrent     prostate cancer. Sulforaphane may prevent or slow the growth of certain cancers.   "
157049|NCT01228071|"     This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal     testosterone range after initial testosterone gel 2% application, time to steady state after     after initiation of testosterone gel 2%, and drying time after application of testosterone     gel 2%.   "
157050|NCT01228058|"     The purpose of this study is to evaluate the clinical utility of thrombelastography (TEG) to     predict and identify trauma patients at increased risk of receiving blood transfusion,     develop multiple organ failure and mortality.      TEG has been proposed as a superior tool to rapidly diagnose and help guide resuscitation     with blood products and preclinical data suggest that TEG is both more sensitive and specific     than PT or PTT for coagulation abnormalities. Based on the preclinical work led by Dr.     Holcomb, our hypothesis is that the Rapid TEG will help to identify these coagulopathic     patients earlier, allow for rapid MT protocol activation, and assist in developing data     driven blood product transfusion guidelines.   "
157051|NCT01228045|"     The investigators hypothesis is that the combination of TS-ONE with cisplatin and trastuzumab     is safe and as effective as combination treatment for HER2 positive gastric cancer.   "
157054|NCT01228006|"     It is hoped that the group treated with Panax Ginseng, Vitamins and Minerals obtain     significant reduction in levels of stress and fatigue and that the results are superior to     the placebo group.   "
157055|NCT01227993|"     Background:        -  Central serous chorioretinopathy (CSC) is a disease in which fluid accumulates under the          retina and can cause distorted vision. CSC often resolves on its own without treatment,          but in chronic CSC the fluid persists and can lead to permanent visual loss. Chronic CSC          may be partly caused by hormones called androgens.        -  Finasteride is a drug that can modulate the effects of androgens; currently it is          marketed as a treatment for male pattern baldness and benign prostate enlargement. The          results of a previous brief study suggest that finasteride is safe and may help reduce          the effects of chronic CSC. However, more long-term data are needed to evaluate whether          finasteride is a safe and effective treatment for chronic CSC.      Objectives:      - To collect more data on the safety and effectiveness of finasteride as a treatment for     chronic central serous chorioretinopathy.      Eligibility:      - Individuals who previously participated in NCT00837252 (NIH protocol 09-EI-0075), Pilot     Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous     Chorioretinopathy, and demonstrated clinical improvement on finasteride treatment.      Design:        -  The study requires 11 visits to the NEI outpatient clinic over 5 years, with visits          occurring every 6 months. Participants will be screened with a medical history, physical          examination, eye examination, and blood and urine tests.        -  At each visit, participants will receive a supply of finasteride pills to take every day          and will need to bring any leftover finasteride pills to the following visit.        -  Participants will have eye examinations to test vision, eye pressure, eye movements, and          retinal thickness. Additional eye examinations will evaluate the retina's sensitivity to          light and study the blood vessels and flow of blood in the eyes.        -  Blood and urine samples will be taken throughout the study.        -  After the end of the study, participants may be able to speak to their doctor about          continuing finasteride treatments with a prescription.   "
157056|NCT01227980|"     Background:      - Individuals who are dependent on alcohol often have feelings of anxiety, irritability,     anger, and depression. These feelings, as well as stress, may contribute to the risk of     relapse and continued drinking. Studies have shown that alcohol consumption increases the     activity of certain molecules in the brain known as CRH1 receptors, which are key to     producing the body s response to stress, and whose activation generates feelings of anxiety.     Researchers are interested in learning whether the experimental drug pexacerfont, which     blocks CRH1 receptors and has been studied in individuals with anxiety disorders and     depression, can lessen anxiety and craving for alcohol as part of alcohol-dependence     treatment.      Objectives:      - To determine the safety and effectiveness of pexacerfont as a treatment for anxiety-related     alcohol craving.      Eligibility:      - Individuals between 21 and 65 years of age who are alcohol-dependent and have problems with     anxiety.      Design:        -  This study requires an inpatient admission to the NIH Clinical Center for approximately          1 month, with two additional study visits 1 week and 1 month after discharge from the          hospital.        -  Participants will be screened with a medical history, physical examination, and blood          and urine tests.        -  During the inpatient period, participants will have standard treatment for alcohol          dependence, including support and interventions from institute staff to address          cravings, anxiety, or other psychological problems. Participants will not receive formal          psychological treatment or psychiatric medications for anxiety, but will receive          training in relaxation techniques.        -  Participants will be assigned to take either pexacerfont or placebo for 3 weeks. During          this time, participants will have the following procedures:        -  Frequent blood tests.        -  Rating scales and questionnaires about alcohol cravings and anxiety.        -  Dexamethasone suppression test with frequent blood draws to study hormone response to          stress.        -  Social stress test involving public speaking, followed by blood samples and          questionnaires on alcohol craving.        -  Cue Reactivity (CR) session to study cravings and responses to alcohol-based cues.        -  Functional magnetic resonance imaging scan to evaluate brain activity while taking the          medication or placebo.        -  Participants will have two follow-up visits for additional blood tests and          questionnaires about the effects of the treatment ^.   "
157057|NCT01227967|"     Seasonal influenza is responsible for many hospitalizations and deaths each year, despite     effective antiviral treatments. Some individuals have medical conditions such as heart or     lung diseases that make them particularly at risk of severe influenza infections that may     result in hospitalization or death. Oseltamivir (Tamiflu) is used most often to treat flu,     but there are still many hospitalizations, complications, and deaths even with treatment.     This study evaluated the use of combination antivirals (amantadine, oseltamivir, and     ribavirin) compared to oseltamivir alone in the treatment of influenza in an at-risk     population.   "
157058|NCT01227954|"     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.      PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain     radiation therapy works in treating patients with brain metastases.   "
157059|NCT01227941|"     This study will determine whether MK-4827 can be safely administered in combination with     pegylated liposomal doxorubicin, and if so, will obtain an estimate of the benefit of the     combination in patients with ovarian cancer as compared to historical data with single agent     pegylated liposomal doxorubicin. The first part of the study (Part A) is designed to     determine the maximum tolerated dose (MTD) and evaluate the safety of MK-4827, when     administered in combination with pegylated liposomal doxorubicin. Part B is designed to     assess preliminary clinical activity of MK-4827, when administered in combination with     pegylated liposomal doxorubicin to participants with ovarian cancer. It is hypothesized that     MK-4827 can be administered, in conjunction with pegylated liposomal doxorubicin, with     acceptable tolerability and that MK-4827, administered in conjunction with pegylated     liposomal doxorubicin, will demonstrate a tumor response rate equal or superior to that of     historical data for pegylated liposomal doxorubicin alone.   "
157060|NCT01227928|"     This is a study to determine whether therapy with pazopanib is effective and safe in Asian     women with epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer has     not progressed on first-line chemotherapy.   "
157061|NCT01227915|"     The primary objective of this study is to evaluate, through clinical parameters, the     comparative efficacy between topical Tobracort ® (tobramycin 0.3% dexamethasone + 1% -     Chemistry Lab Union) and TOBRADEX ® (tobramycin 0.3% dexamethasone + 1 % - Alcon Lab), using     the percentage of improvement (sustained response rate) at the end of treatment.   "
157062|NCT01227902|"     The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and     health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the     following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine,     lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures     (POS) using a flexible dosing regimen.   "
157063|NCT01227889|"     BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and     tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced     (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg     of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until     disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will     be allowed to crossover to an optional extension arm of the study to receive GSK2118436.   "
157064|NCT01227876|"     Is the primary objective of this investigation to compare the clinical efficacy of the drug     test - Ster ® (prednisolone 1% ophthalmic suspension - Union Chemicals) in the comparator -     Fort ® Pred (prednisolone 1% ophthalmic suspension - Allergan) in the control of     postoperative inflammation in cataract surgery by phacoemulsification through periodic     measurement of efficiency scores (number of cells in the anterior chamber, the presence of     fibrin in the anterior chamber, conjunctival hyperemia, corneal edema and Descemet folds).   "
157174|NCT01226433|"     This observational study will assess a model for providing family planning through quarterly     events organized by dairy cooperatives supported by Land O'Lakes in Kenya.   "
157066|NCT01227850|"     Background and study hypothesis:      Refeeding syndrome is a dangerous condition which could arise if patients who have had little     or no food for many days, are started on any form of feeding. The metabolic consequences of     this condition could affect the heart, lungs and nervous system of the patient and cause     serious imbalance in the level of salts in the body.      The available guidelines for predicting that refeeding syndrome may occur are very subjective     since they depend mainly on a history which is sometimes difficult to obtain from the     patient.      The main biochemical landmark that refeeding syndrome has occurred is a fall in the phosphate     levels once feeding has been started. There are currently no biochemical markers that can     identify patients at risk of developing refeeding syndrome.      Leptin and IGF1 are hormones which have been observed to go down if someone has had little or     no food for a while. The investigators therefore hypothesized that using a combination of     leptin and IGF1 values in a 'Refeeding Index' would make the latter a useful biochemical     marker to predict that refeeding may occur, hence take the precautionary measures to avoid     its occurrence before starting feeding.      Design: Thirty five consecutive patients referred for commencement of parenteral nutrition     (PN) were included. Serum leptin and IGF1 were measured prior to starting PN. Electrolytes,     liver and renal function tests were measured before and daily for one week after initiating     PN. The primary outcome was a decrease in phosphate on day two or three after initiating PN.     A 'Refeeding Index' (RI) was defined as leptin x IGF1 divided by 2800 to produce a ratio of     1.0 in patients who are well nourished.   "
157067|NCT01227837|"     In this double blinded study patients with resynchronization pacemaker- AICD were assigned to     Omega3 and placebo randomly, results indicated that Omega3 had no more effect than placebo in     mortality, BNP level and 6 minutes walk test.   "
157068|NCT01227824|"     The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50     mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested     at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI     therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult     subjects.   "
157069|NCT01227811|"     The present study was designed to assess the bioequivalence and pharmacokinetic profiling of     a brand generic formulation of darifenacin [Darisec(R)]vs. the innovator [Enablex(R)]in     healthy volunteers after a high fat breakfast.      The bioequivalence will be evaluated using:        -  the Area Under the Curve (AUC) and,        -  the peak plasma concentration (Cmax).      Safety will be evaluated recording:        -  vital signs        -  adverse events,        -  laboratory analysis.        -  EKG and chest XRays.      Bioequivalence will be claimed if the drugs comply with local regulatory requirement, eg.:        -  mean AUCt/AUCr and 90% confidence interval within 0.80-1.25        -  mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25.   "
157070|NCT01227798|"     A Pilot Study to Evaluate the Safety and Efficacy of interferon-Alfacon1 (INFERGEN) in the     treatment of patients hospitalized with Influenza-like illness caused by a novel swine origin     Influenza virus and other circulating Influenza Viruses.      The use of Interferon-alfacon1 as a co-treatment along with the standard of care antiviral is     hypothesized to be safe. Clinical improvement of patients is hypothesized to be quicker.   "
157071|NCT01227785|"     This study has 2 purposes:      The first purpose of the study is to test a new family of Boston Scientific Implantable     Cardioverter Defibrillators (ICDs) and cardiac resynchronization therapy ICDs (CRT-Ds)     and show how well these new devices work in patients. This new family is called the INCEPTA     ICD and the INCEPTA CRT-D.      The second purpose of the study is to collect data from a feature that monitors breathing. It     is called the Respiratory Rate Trend (RRT). These data will help to better understand how     changes in breathing relate to changes in clinical conditions.   "
157072|NCT01227772|"     Active vaccination with tumor specific antigens and VEGFR1 HLA-A24 epitopes can improve     survival of patients with advanced Gastric Cancer.   "
157073|NCT01227759|"     This IIa study with intraindividual comparison of treated versus untreated to assess the     wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an     abrasive wound healing model.   "
157074|NCT01227746|"     Imatinib is the current standard treatment for advanced GIST. Previous studies have shown     that GIST genotype was associated with treatment outcomes with exon 11 having superior     outcome compared with exon 9 or WT.10, 11 In patients with exon 9 kit mutation, the response     rate was higher at when imatinib was given at 800mg daily compared with the standard dose of     400mg daily. Although the data linking tyrosine kinase mutation status and imatinib response     in metastatic GISTs is intriguing, more information is needed before mutation testing is     adopted as part of the routine analysis of high-risk or overtly malignant KIT-expressing     GISTs.25 Despite the fact that exon 9 mutations are associated with a lower response rate,     overall survival does not appear to be better with high-dose therapy. The investigators     propose to conduct a retrospective analysis of mutational analysis on patients with GIST and     determine the relationship between patient response and imatinib dose.   "
157075|NCT01227733|"     Adequate quality and quantity of RNA may be extracted from paraffin-embedded tumor blocks for     gene expression analysis. This has clinical relevance as gene expression signatures may then     be profiled using archival tumor blocks, which are more readily available than frozen     tissues.   "
157076|NCT01227720|"     Comparative pharmacokinetic study of new oral nicotine replacement therapy products.   "
157077|NCT01227707|"     This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus     Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic     region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer.     Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2     weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy.     After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of     the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.   "
157162|NCT01226589|"     Adverse drug events can occur commonly due to medication errors during the transition of care     in a health care facility. Medication reconciliation is the process of comparing medications     and providing an accurate medication list as a resource for prescribers, which is currently     only being done upon inpatient admission at the CCI. The purpose of this study is to see if     pharmacist medication reconciliation at discharge reduces unintentional medication     discrepancies for inpatient discharges.   "
157078|NCT01227694|"     This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15     patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the     study with the primary objective of assessing the feasibility and safety of the knee     articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary     objectives are to assess the efficacy by imaging procedures and clinical questionnaires.      MSC obtained from each patient's bone marrow will be isolated and expanded Ex-Vivo under     GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21     days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC     in the knee by articular injection, and followed up for 12 month. Articular cartilage changes     will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will     measure the pain by the visual analogue scale (VAS), the self-reported functional status by     Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire     (SF-36) at 3, 6 and 12 month.      The working hypothesis proposes that the expected regenerative articular cartilage effect of     the MSC will be produced to a measurable degree by imaging procedures and clinical     questionnaires.   "
157079|NCT01227681|"     The purpose of this study is to evaluate the effectiveness of neuroprotection from     granulocyte colony-stimulating factor on Parkinson disease   "
157080|NCT01227668|"     The purpose of this study is to determine whether pediatric participants with irritability     associated with autistic disorder who have responded to aripiprazole treatment will     experience a relapse significantly later when continuing therapy with aripiprazole than will     participants who receive placebo   "
157081|NCT01227655|"     Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an     estimated incidence of 4.5-16/100,000 persons/year.      BIA 9-1067 is currently being developed by BIAL (Portela & Cª,S.A.) to be used in addition to     L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising     results have been obtained for BIA 9-1067 in previous studies.   "
157082|NCT01227642|"     In standard treatment, the seeds are placed throughout the prostate to treat the entire     prostate. This is done because it was impossible to know where the cancer was located within     the prostate. A new technique has been developed using the same ultrasound imaging that you     probably had when you had your biopsy. Using this technique, areas likely to contain prostate     cancer can be identified.In this early study of 15 subjects, we will test if this method to     plan your prostate seed implant is safe and can be done as part of regular care. Areas     identified as suspicious for cancer will be treated with higher doses of radiation while     those areas not demonstrating cancer will be treated to the standard minimum dose. The higher     dose areas will receive two times the minimum dose the prostate usually receives. Because     this technique is not perfect, those areas not identified as cancerous should be treated in     case there is a cancer area that the technique did not identify. Subjects enrolled in this     study will then be followed with this ultrasound technique over the next two years to monitor     the changes to the cancerous areas and will undergo a biopsy two years after the procedure.     Subjects will, of course, be monitored to assess the success of the technique and its side     effects.   "
157083|NCT01227629|"     The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or     in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and     other adverse events.      A secondary objective of this trial is to evaluate the anticoagulant effect of different     doses of BIBR 1048, based on the reduction of plasma concentrations of D-dimer, a laboratory     marker for activated coagulation in patients with atrial fibrillation (AF), and to correlate     bleeding and other events with pharmacokinetic (PK) and pharmacodynamic (PD) data.   "
157084|NCT01227616|"     The objectives of this study are to compare the efficacy and safety of repeat doses of     intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with     hemodialysis-dependent CKD.   "
157085|NCT01227603|"     Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence     of a new fixed dose combination tablet of nifedipine GITS and candesartan with the     corresponding loose combination and to compare it with the individual drugs   "
157086|NCT01227590|"     The study is being conducted to evaluate whether African potato, an herbal medicine, can be     used together with anti-HIV medicines without affecting the amounts of the anti-HIV medicines     in the blood. African potato is an African herbal medicine widely used in Africa,     particularly sub-Saharan Africa. Although it has not been proven, it is believed to help     boost the immune system. Similar studies have been done on herbal medicines especially those     that are used in developing countries. In some cases, the herbal treatments can affect the     blood levels of other medicines when the medicines are used together. This study will measure     the effect of African potato on lopinavir/ritonavir (Kaletra®), a common anti-HIV medicine.     Lopinavir/ritonavir is approved by the United States Food and Drug Administration (FDA). The     information obtained from this study will tell us if African potato and anti-HIV treatments     can be used together to treat HIV infected patients in Africa and other resource poor     regions.   "
157087|NCT01227577|"     This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in     adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic     myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and     deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate     of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients.   "
157088|NCT01227564|"     This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and     tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as     measured by positron emission tomography (PET) scans.   "
157089|NCT01227551|"     The purpose of this study is to assess the clinical efficacy of Intratumoral (IT) CVA21 in     terms of immune-related Progression-Free Survival (irPFS) at 6 months as monitored via     immune-related Response Criteria [irRECIST 1.1] (revised Response Evaluation Criteria In     Solid Tumors [RECIST] 1.1).   "
157208|NCT01225991|"     The purpose of this study is to examine the effects of milnacipran for the treatment of pain     in rheumatoid arthritis in older adults.   "
157267|NCT01225198|"     The investigators hypothesis is that a new, revised formulation of a vitamin/mineral     supplement will result in:        1. improvement of nutritional status in some children/adults with autism, and        2. reduction of some of the symptoms of autism in some children   "
157090|NCT01227538|"     Type 1 diabetes is condition in which progressive autoimmune destruction of insulin-producing     beta-cells leads to absolute insulin deficiency. At the time of clinical presentation, it is     estimated that 50-80% of beta-cell function has been lost. Good glycaemic control from     diagnosis has been shown to preserve beta-cell function. The recent identification of     immuno-interventions able to reduce autoimmune destruction and preserve beta-cell function     has lead to an increased urgency to develop such tools.      With mixed-meal stimulated serum C-peptide being a gold standard, there are currently no     tests that are suited for use in clinical practice to detect and monitor residual beta cell     function. There is a therefore a need for a test that is sufficiently sensitive to assess     beta cell function reserve in Type 1 diabetes for clinical practice purposes, which will be     simple, reproducible and suitable for use even in the non-observed setting.      Using mixed meal stimulation of plasma C-peptide (stable by-product in insulin secretion that     reliably reflects insulin production) response as a reference, we propose to compare mixed     meal stimulated urinary C-peptide as potential candidate for this application. This is a     pilot investigation in which a sample of 30 participants will be recruited.      It is anticipated that the current project will identify a simple method for analysing beta     cell reserve in Type 1 diabetes. This will then be applied to screening clinic populations of     recently diagnosed patients with type 1 diabetes. The aim will be to identify subjects who     may be suitable for early intensified insulin regimes (e.g. insulin pump therapy) and novel     immuno-intervention strategies designed to preserve residual beta cell function and improve     long-term outcomes. Currently such immunointervention has been reserved for subjects within 3     months of diagnosis only, excluding a significant number of subjects who may potentially     benefit.   "
157091|NCT01227525|"     Behavioral and physiologic observations suggest that the injection of local anesthetic is     among the most feared or anxiety producing procedures during dental intervention. Discomfort     during the injection is currently reduced by pharmacologic or mechanical methods. No     technique has proven to be effective for every patient. The VibraJect LLC (USA) was first     introduced in 1995 and was developed under the hypothesis that a vibrating needle would     stimulate large diameter nerve fibers and thereby close the gate to smaller nerves carrying     the pain signal from the injection site. Studies on adult patients have been promising. The     purpose of this study is to investigate the efficacy of the VibraJect dental syringe     attachment in reducing injection discomfort and procedural anxiety in the pediatric dental     population.   "
157092|NCT01227512|"     The purpose of this study is to determine if hospitalized patients with symptomatic     hyponatremia treated with tolvaptan are in the hospital for less time than patients treated     with fluid restriction. The study will also test if tolvaptan is better than fluid     restriction in treating the symptoms of hyponatremia in hospitalized patients.   "
157093|NCT01227499|"     Aim: Graves's disease and thyroiditis can both characterized with thyrotoxicosis, but their     clinical outcome and therapy is quiet different. Measurement of iodine uptake is the gold     standard to differential diagnosis the thyroiditis or Graves's disease. But the iodine uptake     is limited for its availability in china and easily influenced by medicine or food contained     iodine.The blood pattern of thyroid CFDS is useful for differentiate the cause of     thyrotoxicosis.Most previous studies using the descriptive pattern of thyroid CFDS is easily     varied by operator subjective judgement. This study is focus on the role of peak systolic     velocity of thyroid superior artery in differential diagnosis of thyrotoxicosis. Methods:     Patients with thyrotoxicosis symptoms without recent medicine history were enrolled in two     clinical center. Its thyroid function, iodine uptake , CFDS of thyroid and peak systolic     velocity of thyroid superior artery is detected. Thyrotoxicosis is defined as TSH level below     the low value of normal range. Graves disease is defined as the typical symptoms of graves     disease such as graves ophthalmopathy or increased iodine uptake. Thyroiditis is defined as     lack of typical symptoms of graves disease or decreased iodine uptake.We use receiver     operator curve(ROC) to evaluate its diagnosis value   "
157094|NCT01227486|"     The purpose of this study is to determine whether verification of correct tube placement     after endotracheal intubation in the obese patient can be conducted as fast with ultrasound     as with the conventional method of combined auscultation and capnography.      The investigators hypothesize that ultrasound is a faster method for verifying correct     endotracheal tube placement in the obese patient than combined auscultation and capnography.   "
157095|NCT01227473|"     Pre-diabetes, characterized by glucose levels that are above normal but below the diagnostic     criteria for diabetes, is an increasingly common condition, particularly among African     Americans. Changes in physical activity, changes in diet, and levels of stress influence the     course of the disease. Helping individuals to reduce stress and to increase healthy coping     strategies may enhance conventional diabetes prevention efforts, especially among African     Americans. Mindfulness training is a cost-effective intervention which may be effective in     reducing stress and enhancing the ability to make behavioral changes. This exploratory pilot     study will examine the potential efficacy of a diabetes prevention education program that     includes training in mindfulness-based stress reduction (intervention group) for pre-diabetic     African Americans, comparing it to a conventional diabetes prevention program (control group)     in the ability to improve glucose metabolism as well as other relevant physiological and     psychological secondary outcomes.   "
157096|NCT01227460|"     This is a multi-center, prospective, randomized, double-blind, parallel, placebo controlled     clinical trial evaluating the efficacy of sitagliptin in suppressing glucagon release in     subjects with type 1 diabetes over a 16 week treatment period. The hypothesis of this study     is that sitagliptin (Januvia™) will decrease post-prandial glucagon release and may result in     improved glucose control in adult patients with type 1 diabetes. There is only one small,     pilot study of sitagliptin in patients with type 1 diabetes which significantly reduced total     daily insulin dose and A1c values while improving mean blood glucose (MBG) and time spent in     euglycemic range (1). In the pilot study, GLP-1 and glucagon levels were not assessed. The     purpose of this trial is to determine if sitagliptin can suppress the paradoxical rise of     glucagon, and thus can decrease A1c.      This study will enroll a maximum of 140 patients (with an expected 10% dropout rate) with A1c     values between 7.5-10% who will be randomized in a 1:1 fashion to either the study drug or     placebo. 100 of these patients will wear a continuous glucose monitor. Subjects may be using     insulin via continuous subcutaneous insulin infusion (CSII) or multiple daily injections     (MDI). The clinic visits will be conducted at screening, -1 week, baseline/randomization, 4     weeks, 12 weeks, and 16 weeks in addition to telephone visits (Appendix 1 and 2). At home,     starting at week 0 (randomization/baseline), subjects will take 100 mg/day of sitagliptin or     placebo and continue for the study duration. Laboratory analysis will be performed at various     time points assessing glucagon, A1c, C-peptide, glucagon-like-peptide-1 (GLP-1),     glucose-dependent insulinotropic peptide (GIP), and insulin levels.   "
157097|NCT01227447|"     The aim is to find out if adreno-muscarinic synergy is present also in human tissues of the     urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. To further     characterise morphology and function of the suburothelial myofibroblast network in the human     bladder outlet.   "
157099|NCT01227421|"     This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing     regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated     influenza in adults and adolescents. The investigators hypothesize that treatment with     Nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza     infection. Secondarily, the investigators hypothesize that treatment with nitazoxanide will     reduce the complications of influenza, severity of symptoms, time lost from work, time to     return to normal daily activities.   "
157100|NCT01227408|"     The investigators propose to conduct a clinical trial of neoadjuvant treatment utilizing     chemotherapy formulations with favorable toxicity profiles: weekly doxorubicin, PPX and     capecitabine. It is expected this combination will at least maintain the efficacy of a     traditional chemotherapy regimen but will be associated with less toxicity, particularly     nausea, vomiting and alopecia. In order to accomplish this the investigators have designed a     chemotherapy regimen whose components (or administration schedule) are associated with     minimal or no alopecia and are also considered to have low emetogenic potential.      In an attempt to improve the efficacy of the regimen the investigators plan to study an     alternate schedule of cyclophosphamide and methotrexate administration (metronomic     chemotherapy) which appears to inhibit angiogenesis and therefore enhance the activity of     conventional cytotoxic chemotherapy administered concurrently.      In this trial the investigators aim to determine the clinical and pathologic response rate of     12 weeks of doxorubicin followed by 4 cycles of PPX and capecitabine. Metronomic chemotherapy     with cyclophosphamide and methotrexate will be administered during the 24 weeks of     chemotherapy.   "
157101|NCT01227395|"     The investigation will be conducted for the purpose of determining the condition of     occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet,     verifying the therapeutic effects, detecting unknown Adverse Drug Reactions and drug     interactions and determining the factors affecting safety and efficacy.   "
157102|NCT01227382|"     The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis     when compared to standard biopsy techniques.   "
157103|NCT01227369|"     Quality of Life (QoL) in Korean postmenopausal osteoporosis patients with bisphosphonate     treatment   "
157104|NCT01227356|"     Patients with chronic myeloid leukemia in imatinib induced CHR are randomized between     imatinib 400 mg daily and imatinib 400 mg daily + PegIntron 30 ug weekly.      Primary endpoint: To compare at 12 months between the treatment arms the rate of Major     Molecular Response (=99,9% tumour reduction) at 12 months   "
157105|NCT01227343|"     The aim of this study is to assess the impact of smoking on cortical GABA levels in males and     females. Using magnetic resonance spectroscopy (MRS), we will examine the impact of sex and     menstrual cycle phase on brain neurochemistry in healthy smokers and non-smokers. We     hypothesize that female, but not male, smokers will have reduced cortical GABA levels     compared to their non-smoking, sex-matched counterparts.   "
157106|NCT01227330|"     The purpose of this study is to pilot test a behavioral medication adherence (MA)     intervention compared to control condition in older adults with low adherence to medication     for hypercholesterolemia.   "
157107|NCT01227317|"     The purpose of this study is to evaluate the capacity of some novels biomarkers Procalcitonin     (PCT), Midregional Proadrenomedullin (MR pro ADM), Midregional pro-atrial natriuretic peptide     (MR pro ANP), Copeptin (CT pro arginine vasopressin), Pro endothelin to stratify the risk in     severe dyspnea.   "
157108|NCT01227304|"     -  test for volume responsiveness        -  PiCCO-guided infusion over a pre-defined period of time   "
157109|NCT01227291|"     The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with     elevated IOP.   "
157110|NCT01227278|"     To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary     Disease (COPD) in Adults.   "
157111|NCT01227265|"     This is a study of the efficacy and safety of preladenant in adult participants with moderate     to severe Parkinson's Disease (PD). While on this study, participants will continue to take     their usual, prescribed, stable regimen of levodopa (L-dopa) or L-dopa plus adjunct PD     medications and will be randomized to receive 2 mg preladenant, 5 mg preladenant, or placebo,     twice daily, for 12 weeks. After that, participants may choose to receive additional     treatment with preladenant. The primary hypothesis is that at least the 5 mg twice daily dose     of preladenant is superior to placebo as measured by the change from Baseline to Week 12 in     the mean off time.   "
157112|NCT01227252|"     This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of     LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.   "
157113|NCT01227239|"     The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin     combined with radiation by Phase I/II study.      The purpose of this study is as follows,        -  In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated          dose (MTD).        -  In phase II, to evaluate the antitumor effect (pCR rate) and the safety .   "
157114|NCT01227226|"     The effect of artificial tears on tear osmolarity   "
157157|NCT01226654|"     The primary purpose of this study is to detect changes in the brain that may be associated     with multiple sclerosis. Results will be compared to age matched controls. Investigators will     assess lesions by measuring T2 and T1 enhanced lesion volumes and magnetization transfer     ratio histogram parameters (MTRHP) in patients with relapsing-remitting and     secondary-progressive disease. This data will be correlated to total brain parenchymal volume     as well as identifying the effect of MS lesions on the gray and white matter, volumetric     disability, including Kurtzke Expanded Disability Status Scale (EDSS) and a specific battery     of neuropsychological tests. Quantitative analysis of whole brain N-acetylaspartate (WBNAA),     a reproducible measure of viable neuron number, using 1H MRS and compare the results to     age-matched controls over duration of 5 years.   "
157159|NCT01226628|"     The main purpose of this study to evaluate the safety and tolerability of CNTO 2476     administered subretinally (beneath the retina) using the iTrack Model 275 micro catheter in     patients with visual acuity (acuteness or clearness of vision) impairment associated with the     geographic atrophy (GA: partial or complete wasting away of retinal layer below the retina)     manifestation of age-related macular degeneration (AMD: medical condition which usually     affects older adults and results in a loss of vision in the center of the visual field [the     macula] because of damage to the retina).   "
157115|NCT01227213|"     Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has     improved the outcome of patients with several types of cancer remarkably. However, their     application is hampered by side effects, such as development of hypertension with     consequences for renal and cardiac function. Moreover patients treated with angiogenesis     inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to     change. The treatment with angiogenesis inhibitors, will improve life expectancy of patients     with various cancer diagnoses and therefore the clinical relevance of both short term and     long lasting adverse events will translate into reduced quality of life. In addition,     premature withdrawal of angiogenesis inhibitors due to side effects may result in lower     response, shorter duration of response and possibly a shorter survival. Therefore, adequate     treatment of above mentioned side effects in patients treated with angiogenesis inhibitors is     of relevance for the response rate, the duration of progression free survival and overall     survival and for quality of life.      Mechanistic insight in the pathogenesis of these side effects will help optimizing treatment.      Objective: The primary objective of the study is to investigate the effect of sunitinib on     endothelial function, insulin sensitivity, renal function and renal blood flow.      Study design: Single-centre non randomized observational study Study population: 30 Patients     (>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.   "
157116|NCT01227200|"     The purpose of this study is to find if adding oral pain relievers as DYPIRON and TRAMADOL in     addition to the local anesthesia injection, can help reducing the pain intensity in patients     who diagnosed as Suffering from peritonsillar abscess (PTA)and treated by incision and     drainage .   "
157117|NCT01227187|"     The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an     anticoagulant at different dose levels during dialysis treatment in patients with End Stage     Renal Disease (ESRD).   "
157118|NCT01227174|"     The purpose of this study is to determine if the use of propofol only to achieve procedural     sedation for the removal of third molars is both safe and effective.   "
157119|NCT01227161|"     Choosing the adequate size of endotracheal tube(ETT) in pediatric patients is important in     all anesthesiologists, pediatricians, and critical care specialists. Inadequate ETT size will     results in soft tissue injury to trachea by means of the pressure, insufficient ventilation,     and aspiration, therefore choosing the adequate ETT size has very important clinical aspect.   "
157120|NCT01227148|"     To compare the differences of urinary nitrogen excretion, nitrogen balance and clinical     outcomes between tightly insulin therapy and conventional insulin therapy in the ICU.   "
157121|NCT01227135|"     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Biological therapies, such as hydroxychloroquine, may     stimulate the immune system in different ways and stop cancer cells from growing. It is not     yet known whether imatinib mesylate is more effective when given with or without     hydroxychloroquine in treating patients with chronic myeloid leukemia.      PURPOSE: This randomized phase II trial is studying the side effects of giving imatinib     mesylate with or without hydroxychloroquine and to see how well it works in treating patients     with chronic myeloid leukemia.   "
157122|NCT01227122|"     Primary endpoint: To evaluate predictive value of plasmatic levels of Neutrophil Gelatinase     Associated Lipocalin (NGAL) to reveal acute kidney failure after cardiac surgery in patients     with preoperative chronic kidney failure Secondary endpoint is to obtain threshold values of     NGAL.   "
157123|NCT01227109|"     Infections pose a serious threat to cancer patients in chemotherapy. Prompt diagnosis and     treatment is of paramount importance as infections may be life-threatening in     immune-compromised individuals. Traditionally, the C-reactive protein (CRP) has been used as     a marker of infection. However, the CRP is also often elevated in cancer patients and as a     marker CRP may be unreliable in cancer patients. Other markers for infection includes     procalcitonin which has been showed to be of some value for the diagnose of bacterial     infections.      This study examines procalcitonin as a potential marker of bacterial infection in cancer     patients.   "
157124|NCT01227096|"     The purpose of this study is to determine whether electroacupuncture preconditioning would     provide protection against myocardial Ischemic-Reperfusion injury and systemic inflammation     in children undergoing CPB for repair of congenital heart defects.   "
157125|NCT01227083|"     Comparison of the responsiveness of two different asthma-specific QOL measures (AQLQ and     cAQOL) in Korean patients with persistent asthma   "
157126|NCT01227070|"     This study is a longitudinal single-center pilot study designed to describe changes in lung     function and levels of noninvasive biomarkers of airway inflammation in children ages 6-18     years over two months following hospitalization for an acute exacerbation of asthma. Forty     children ages 6-18 years with asthma who are admitted to Children's Hospital and Regional     Medical Center (GCRC) for an asthma exacerbation will be enrolled and complete an initial     study visit prior to hospital discharge. Children with asthma will be recruited from the     inpatient medical unit. During their initial visit subjects will undergo a clinical     assessment and perform spirometry to measure lung function. In addition, exhaled nitric oxide     (eNO) concentration will be measured and a sample of exhaled breath condensate (eBC) will be     collected during 20 minutes of tidal breathing. Breath condensate will be analyzed to     determine the concentration of cysteinyl leukotrienes (CysLT), an important mediator of     airway inflammation in asthma. Subjects with asthma will return to the GCRC pediatric     satellite at Seattle Children's Hospital for follow-up study visits at 1 week, 2 weeks, and 4     weeks following hospital discharge. During follow-up visits subjects will complete a     questionnaire regarding symptoms and medication use since the most recent study visit, will     perform spirometry, and have eNO concentration measured and breath condensate collected for     CysLT analysis.      The aims of this observational study are to:        1. Assess the association of levels of exhaled nitric oxide and cysteinyl leukotrienes in          breath condensate with measures of airflow obstruction (FEV1) and asthma symptoms          during, and at one, two, and four weeks following hospital discharge for asthma          exacerbation.        2. Compare levels of exhaled nitric oxide and cysteinyl leukotrienes in breath condensate          from children ages 6-18 years hospitalized for status asthmaticus to levels from          age-matched healthy control subjects without asthma.   "
157127|NCT01227057|"     The purpose of this investigation is to examine treatment outcome of a new intervention for     hoarding in older adults compared to standard case management for hoarding. The new     intervention combines exposure therapy and cognitive remediation.   "
157128|NCT01227044|"     This is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX)     and counseling on highly active antiretroviral treatment (HAART) medication adherence in a     cohort of HIV-infected patients who report heavy drinking, or meet criteria for alcohol abuse     and/or dependence, and inadequate (< 95%) HAART adherence. All patients will receive a     behavioral intervention, termed Medical Management/Medication Coaching or MM/MC. MM/MC     incorporates the behavioral platform Medical Management (MM) from the National Institute on     Alcohol Abuse and Alcoholism (NIAAA)-funded COMBINE Study to reduce heavy alcohol use with     Medication Coaching (MC), a manualized treatment designed to improve HAART medication     adherence in HIV-infected patients with substance use disorders.   "
157129|NCT01227031|"     Androgenic alopecia, the common form of hair loss is a highly heritable disorder of     considerable social significance affecting around 40% of adult men and women. A variety of     genetic and environmental factors are likely to play a role in androgenetic alopecia. Genetic     variants in the human androgen receptor gene (AR) have been reported to be associated with     AGA in Caucasians. Other genes involved with hair loss also have been found. One of them     being a gene on chromosome 3 (3q26). A recent genome-wide association study in 296     individuals with male-pattern baldness and 347 controls had carried out and five SNPs on     chromosome 20p11 were found to be highly significant association for AGA (rs2180439 combined     P = 2.7 x 10(-15)). No interaction was detected with the X-chromosomal androgen receptor     locus, suggesting that the 20p11 locus has a role in a yet-to-be-identified     androgen-independent pathway.      The total number of evaluated patients with androgenic alopecia will be at least 300. All     patients will be further grouped as good responders or poor responders to conventional     medications, such as topical minoxidil and systemic finasteride. Candidate genes potentially     involved in gout and its treatment response will be selected from the published literatures;     specifically, two resources of candidate genes will be selected: (i) genes which are known to     directly link with androgenic alopecia, and (ii) genes are potentially implicated in     particular pathways of androgen/estrogen receptors, metabolism and downstream signals, and     genes involved in anti-oxidants or hair growth. The SNP genotyping will be performed by     MALDI-TOF Mass Spectrometry. Data analysis will be performed by comparing SNPs allele     frequency between good responder and poor responder to conventional medications of patients     with androgenic alopecia and further comparing to the allele frequency of SNPs in healthy     controls. A functional study will also be done to prove the genetic association.   "
157130|NCT01227018|"     RATIONALE: Heat shock protein (HSP)90 inhibitor STA-9090 may stop the growth of tumor cells     by blocking some of the proteins needed for cell growth. PURPOSE: This phase II trial is     studying how well hsp90 inhibitor STA-9090 works as second- or third-line therapy for the     treatment of patients with metastatic pancreatic cancer.   "
157131|NCT01227005|"     The proposal will assess if patients who require massive transfusion can be accurately     predicted early after emergency department arrival and assess if the use of stored whole     blood during initial resuscitation will reduce transfusion needs compared to transfusion with     component therapy and thus improve outcome.   "
157132|NCT01226992|"     Recurrent CDI is a growing problem with few treatment options that provide lasting effect.     Fecal transplantation has been shown in several case series to be successful in controlling     recurrent CDI. The current study is a non-blinded, randomized controlled trial comparing     fecal transplantation with a 6 week taper of oral vancomycin for the treatment of refractory     CDI. Approximately 146 patients will be enrolled over one year. Participants in the study     will be followed for 120 days, and will be given the opportunity to cross over to the     alternative intervention arm if a relapse in symptoms occurs. The primary outcome measure     will be recurrence of toxin-confirmed CDI within 120 days of starting the intervention.     Secondary outcomes include: early recurrence of symptoms within 14 days, relapse within 120     days (same strain of C. difficile), attributable mortality, hospitalization and serious     adverse events.   "
157133|NCT01226979|"     This research is being done to see how effective high-dose rate endorectal brachytherapy     (HDRBT) is in treating cancer of the lowest part of the bowel (rectum). In this study we want     to try to decrease side effects and shorten the course of radiation treatment for patients     with cancer of their rectum by using a high-dose rate endorectal brachytherapy (HDRBT). This     is a different form of radiation than what is normally given. With HDRBT, the radiation is     given through an applicator placed into the bowel next to the tumor. The radiation is     directed at the tumor and a small area around it.   "
157134|NCT01226966|"     This observational study is conducted in Europe. The aim of this non-interventional     (observational) study is to evaluate the efficacy of liraglutide (Victoza®) and to assess the     conditions of use of Victoza® in daily medical practice in France.   "
157135|NCT01226953|"     This study will evaluate the safety and immunogenicity of booster dose of two commercially     available vaccines used to prevent Haemophilus influenzae type b infections in children     365-569 days of age   "
157136|NCT01226927|"     The optimal infusion technique (continuous rate vs. intermittent bolus) for peripheral nerve     blocks has not been established. To our knowledge, this is the first study to compare the     efficacy of an automated intermittent bolus technique to a continuous rate of infusion of     local anesthetic in femoral nerve catheters. We hypothesized that the intermittent bolus     technique would provide enhanced analgesia compared to a continuous infusion rate as assessed     by intravenous patient-controlled analgesia (IV-PCA) hydromorphone consumption and visual     analog scale (VAS) pain scores.   "
157137|NCT01226914|"     Primary Objectives        -  To compare the amount of post-operative wound drainage between the group of patients in          which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™          placebo is utilized (Arm B).        -  To compare the length of time to drain removal between Arm A and Arm B. Secondary          objectives        -  To compare the incident or rates of seroma, hematoma, and post-operative edema between          the two groups.        -  To compare the reported pain experienced in each group at selected time points using a          standard numerical rating scale (NRS).        -  To compare the length of hospital stay between the two groups of patients.   "
157138|NCT01226901|"     This study will evaluate whether oral administration of MK-4827 to participants with advanced     solid tumors is generally safe and well tolerated.   "
157139|NCT01226888|"     Androgen deprivation therapy (ADT) is considered standard of care for prostate cancer.     However, changes in the patients metabolism are usually seen as a result of hormone therapy.     These changes include increased fat mass, decreased lean mass, weight gain, high blood     cholesterol, increased incidence of diabetes, and possibly increased incidence of cardiac     events such as heart attack. The researchers of this trial would like to learn if these     change in body mass are affected by the presence of brown fat in the body. Brown fat is made     up of fat cells that are stored in the body and generate heat to control body temperature.     Levels of brown fat are at the highest in newborn babies and decrease over time into     adulthood. The researchers of this trial would like to learn more about these changes in     metabolism during prostate cancer treatment by studying the changes in brown fat during the     first 12 months of hormone therapy.   "
157140|NCT01226875|"     Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL     energy is focused on in order to break kidney stones and this energy can be varied in size     from a narrow (or small) focal zone to a wide (or large) focal zone. This is a     multi-centered, randomized study comparing the single treatment success rates of narrow and     wide focal zones during SWL.   "
157141|NCT01226862|"     This study will promote the development and economic sustainability of telemedicine for acute     stroke treatment.   "
157142|NCT01226849|"     Incorporation of rituximab to conventional chemotherapy (R-CHOP) has revolutionalized the     frontline treatment of diffuse large B-cell lymphoma (DLBCL), one of the commonest subtype of     lymphoma. Although the majority of patients are cured, there still remains a substantial     number patients (20-30%) who will relapse despite upfront R-CHOP therapy. Recent studies have     informed that in the rituximab era, the ability to salvage patients with relapsed DLBCL with     the conventional salvage regimens like R-ICE or R-DHAP is significantly poorer than expected.     For a patients who has been exposed to rituximab in the frontline, the response rate of     conventional salvage chemotherapy is now a mere 51% (Coral Study). This suggests that     relapses after rituximab exposure are more severe, strongly implying the presence of     rituximab-resistant disease in additional to the selection of more aggressive subtypes of     DLBCL which R-CHOP may not have a significant impact on. As R-CHOP is currently the frontline     standard of care, more has to be done to augment the current available salvage regimens as a     response rate of 51% is unacceptable.      Incorporation of agents targeting rituximab-resistance and also the more aggressive subtype     of DLBCL ( ABC subtype) is prudent in the salvage regimen. Bortezomib, a targeted novel agent     has potent anti-tumor effects on its own. It has also been show clinically to be able to     overcome the adverse risk conferred by the ABC subtype of DLBCL. In addition, preclinical     studies have also demonstrated that bortezomib may enhance the biologic activity of rituximab     through upregulation of CD20, the target of rituximab.      The investigators hypothesize that adding bortezomib to salvage regimen of DLBCL will be more     efficacious. Increasing the response rate will then allow more eligible patients to go on to     autologous stem cell transplantation. The investigators intend to test the tolerability and     efficacy of the combination of bortezomib with the R-ICE regimen, and attempt to correlate     responses with histopathological and gene expression studies of tumor specimens.   "
157143|NCT01226836|"     The purpose of this study is to assess the feasibility and acceptability of the revised     Living Well With COPD programme (LWWCOPD for Pulmonary Rehabilitation) when used to deliver     the education component of pulmonary rehabilitation.   "
157144|NCT01226823|"     The study is a multicenter randomized double blind placebo controlled trial. The study will     be conducted on pregnant women with a diagnosis of intrahepatic cholestasis of pregnancy     (ICP) in third level hospitals (that are also Academic Hospitals).      Pregnant women at the time of ICP diagnosis will be randomized in two groups:      Group 1 - will receive placebo and obstetrical monitoring until delivery Group 2 - will     receive UDCA at the dose of 20 mg/Kg/day and obstetrical monitoring until delivery.      The hypotheses are that UDCA treatment will be superior to placebo and effective in:      reducing the rate of prematurity; improving maternal biochemical parameters and symptoms.   "
157145|NCT01226810|"     Purpose of this study is to compare the image quality and diagnostic accuracy obtained with     ultrafast solid state short SPECT in comparison with the routine SPECT protocol.   "
157146|NCT01226797|"     This study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C virus     infection and abnormal liver enzymes.   "
157147|NCT01226784|"     Effects of physical training and relaxation exercise on pathophysiological mechanisms and     symptoms in finbromyalgia patients.   "
157148|NCT01226771|"     This is a randomized, open-label, parallel group, multicenter pilot study evaluating the     efficacy and safety of alternative dosing of ribavirin vs. standard of care dosing in     combination with peginterferon alpha-2a in interferon naïve patients with chronic hepatitis c     genotype 1 infection.   "
157149|NCT01226758|"     The purpose of this research is to study the safety, tolerability and effectiveness of the     investigational influenza vaccine in healthy volunteers infected with an attenuated influenza     A virus.   "
157150|NCT01226745|"     The objective of this active-drug Extension Study is to evaluate the continuing safety and     efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis     (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 [NCT01081782]).   "
157151|NCT01226732|"     The investigators propose this Phase I trial of the combination of AUY922 and capecitabine to     determine the maximum tolerated dose (MTD) in patients with advanced solid tumors. This     combination treatment has potential applicability in tumor types where capecitabine or     fluorouracil is a treatment option, including colorectal and breast cancer.   "
157152|NCT01226719|"     In this Phase II study the investigators plan to determine the overall response rate (ORR) of     the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with     liver-only metastatic KRAS wild-type colorectal cancer.   "
157153|NCT01226706|"     Non-neurogenic urinary urge incontinence (UUI) is a common quality of life disorder that     causes people to feel an urgent need to urinate. Standard treatment for UUI includes     behavior modification, pelvic floor exercises, anticholinergic medication, and less commonly,     sacral neuromodulation. Unfortunately anticholinergic therapy is only moderately effective.      Botulinum toxin A (BTA or Botox©) may be a useful treatment in patients that do not respond     to standard therapy. Botulinum toxin A has been used in other studies to improve symptoms in     neurogenic urinary incontinence, and a variety of lower urinary tract disorders. BTA has been     used in other studies to improve the symptoms in urinary incontinence, migraines, spinal cord     injuries and a variety of lower urinary tract disorders. However, the treatment of     non-neurogenic urinary urge incontinence has not been examined in a well-controlled study.      The primary purpose of this study is to determine the efficacy of botulinum toxin A (BTA) in     the treatment of non-neurogenic urinary urge incontinence (UUI). The secondary objectives are     to examine the side effects associated with BTA treatment and the impact this treatment has     on patients' quality of life.   "
157154|NCT01226693|"     There is no difference in the rate and extent of absorption of the material sparing tablet     (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3     formulation without SLS.   "
157155|NCT01226680|"     This is a phase 2 study to further evaluate the safety and efficacy of tasocitinib     (CP-690,550) in the subjects with moderate to severe dry eye disease. Both subjective and     objective clinical endpoints will be measured for a duration of 12-week treatment.   "
157156|NCT01226667|"     A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week     baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for     one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID     (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4     weeks.It is proposed that use of flexible dosing combined with nightly dosing would have     similar pain relief to fixed dosing, would improve adherence, would have less side effects     and would be more likely to improve sleep.   "
157158|NCT01226641|"     The aim of this study is to determine the usefulness of a telemedicine system for the     follow-up of OSA patients with a high cardiovascular risk. Our hypothesis is that the     telemedicine system will enhance compliance and thus reduce self-measured blood pressure.   "
173020|NCT00098189|"     This extension study is being conducted to collect post-treatment safety information on     patients who previously participated in the core clinical trial.   "
157163|NCT01226576|"     The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has the     potential to be a safe and effective non-invasive treatment for low to intermediate risk,     organ-confined prostate cancer involving low incidence of morbidity. The study hypothesis     will be tested by measuring treatment-related safety and initial effectiveness parameters in     the ExAblate MRgFUS treated patients, as described above.      Based on the result of this study, InSightec will initiate a larger study in an effort to     approve low risk, organ-confined prostate cancer as an indication for its ExAblate MRgFUS     device.   "
157164|NCT01226563|"     The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for     the prevention of ventricular remodeling and congestive heart failure when administered to     subjects who had successful percutaneous coronary intervention with stent placement after ST     segment elevation MI (STEMI).   "
157165|NCT01226550|"     This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of     optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy (HIPEC)     with mitomycin C (MMC) and irinotecan. The latter drug will be administered in escalating     doses to patients with gastric, colorectal, appendicular, or primary peritoneal carcinosis     (PC).   "
157166|NCT01226537|"     Diabetes mellitus (DM) and its vascular complications are the one of the most prevalent     diseases in the state of Qatar. It is a multifactorial disease associated with the     development of retinopathy, nephropathy, neuropathy, cardiomyopathy, and severe vascular     dysfunction. The complications of diabetes are caused by either insulin deficiency (type 1     DM) or insulin resistance (type II DM).Unfortunately, effective and sustainable prevention     programs of diabetes are limited, and treatment options for type II DM are restricted.     Current therapy is based upon control of blood glucose, cholesterol and triglycerides,     primarily through insulin replacement in type I diabetes or oral hypoglycemic agents and/or     insulin replacement in type II diabetes. New therapies able to prevent vascular complications     of diabetes are needed to decrease the occurrence of end organ damage and improve the quality     of life of the people. Safe and effective nutritional supplements that could be given along     with the regular treatment of the patients that might reduce the need for insulin replacement     therapy provide tighter glucose control and protect against oxidative stress and the vascular     pathology associated with diabetes mellitus are the need of the hour. Our hypothesis is that     supplementation of Taurine in the diets of diabetic patients might reduce the dose or need     for insulin replacement therapy and protect them against oxidative stress that is responsible     for the complications of diabetes mellitus.   "
157167|NCT01226524|"     Immune thrombocytopenia (ITP) is an autoimmune disorder manifested as isolated low platelet     count which results in a tendency for bleeding. Around 10% of childhood ITP does not reach     resolution within 1 year thus becoming chronic ITP. Therapeutic modalities at present are     aimed to achieve symptomatic relief, do not change the natural course of the disorder and are     associated with potential side effects and increase cost. Thus, identifying a new therapy     that would decrease the bleeding symptoms, without causing significant adverse effects, could     be very beneficial. Preliminary reports demonstrate a beneficial role for Traditional Chinese     medicine (TCM) in the treatment of ITP.      Working hypothesis and aims: The use of TCM will improve the status of children with chronic     ITP and thus will reduce the need to use conventional medications. The investigators aim to     study whether in children with chronic ITP, supplementation with TCM, improves the bleeding     symptoms and ITP-related quality of life (QOL) compared to the period prior to the     intervention? Methods: The study includes three periods: 1st observation period (1 month),     TMC period (3 months) and 2nd observation period (2 months). During all study periods the     following data will be collected: bleeding symptoms, bleeding score, platelet count, need for     conventional therapy, side effects of therapy and ITP-related QOL.   "
157168|NCT01226511|"     The purpose of this study is to find out if duloxetine [30-120 milligrams (mg)] given once a     day by mouth for 10 weeks to children and adolescents, is better than placebo when treating     Generalized Anxiety Disorder (GAD).   "
157169|NCT01226498|"     The objective of this study is to assess effects of the storage of PRBC on endothelial     function, inflammation and platelet activation in healthy volunteers   "
157170|NCT01226485|"     The purpose of this study is to find a recommended dose level and schedule of dosing RXDX-109     (formerly LY2940680) that can safely be taken by patients with advanced cancer. The study     will also explore the changes in a cancer marker level in skin, hair follicles, buccal cells,     and tumor cells. Finally, the study will help document any antitumor activity this drug may     have.   "
157171|NCT01226472|"     This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous     T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have     relapsed after achieving a complete response in study, KW-0761-001.   "
157175|NCT01226420|"     Alefacept is a drug tht may reduce the number of T cells in circulation. This drug has been     used in the treatment of psoriasis, which is a skin disorder also caused by T cells, like     chronic GVHD. Information from studies in psoriasis and in other patients with GVHD suggests     that this drug may help to treat chronic GVHD. Chronic GVHD is a medical condition that can     develop after allogeneic stem cell transplantation. It occurs when the donor immune cells     (the graft) attack and damage organs and tissue (the host). It is thought that T cells, a     subtype of immune cells, are responsible for the tissue damage in chronic GVHD. In this     research study we are looking to see how well Alefacept works in treating chronic GVHD that     has not resolved after therapy with corticosteroids.   "
157176|NCT01226407|"     Open label, single dose and phase I study.      The primary objective: To determine the maximum tolerated dose in Single dose      The secondary objective: to evaluate the toxicity in administration to determine desirable     dosing amount for phase II to evaluate tumor response in progressive solid cancer patients to     evaluate pharmacokinetic/ pharmacodynamic profile.   "
157189|NCT01226238|"     Patients with major depression who are on a waiting list for psychotherapy usually suffer     from considerable symptoms. Online self-help is one potential way to alleviate this     suffering. The investigators want to study if patients awaiting psychotherapy benefit from     online-self help. The investigators therefore randomly assign patients to either online     self-help or no intervention and assess their depressive symptoms on a regular basis. The     investigators hypothesize that online self-help will be superior to no intervention in     alleviating depressive symptoms in depressed patients awaiting psychotherapy.   "
157177|NCT01226394|"     Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal     Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent     and will be pre-registered. All patients will receive the current standard adjuvant treatment     : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified     if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of     a recurrence is low but if this occurs, the patient will not be randomised and will be     treated with the best known treatment. If the work-up is negative, patients will be     randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC     (experimental group).   "
157178|NCT01226381|"     This is a Crossover study, double-blind, randomized, controlled versus placebo.   "
157179|NCT01226368|"     Cervical cancer is a public health problem. In term of frequency and mortality, it represents     in Martinique the third localization the most frequently diagnosed and the fifth cause of     death by cancer. Cervical cancer is recognized as viro-inducted. Human papillomavirus (HPV)     is the etiologic agent, as a necessary but not sufficient cause, in the cancer genesis. It is     estimated than about 70 to 80% of women have been or will be infected with an HPV in their     genital life, the risks factors being those of the others sexually transmitted diseases     (STD). Most of HPV infection are transient, by spontaneous clearance in a few months of the     virus under episomal form.      Carcinogen risk is related to viral persistency which inducts the condition of cellular     transformation.      Infection persistency and subsequent carcinogen risk depend of the genotype concerned and of     the host immunitary response.      HIV infection is known to be associated with an higher prevalency of one or several infection     with HPV-HR.      However, no data about HIV/HPV coinfection prevalency are available nowadays in French     overseas department of South America whereas they are the most affected by HIV.   "
157180|NCT01226355|"     A single blind, multi-center, randomized study is preformed to compare NOYA CoCr     biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from     MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr     biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.   "
157181|NCT01226342|"     Transcutaneous electrical muscle stimulation (TCEMS) is well established intervention for     rehabilitation of clinically stable patients with chronic obstructive pulmonary disease.      The investigators have conceived this study to test whether TCEMS is feasible and tolerated     by patients experiencing severe physical and psychical challenge of acutely exacerbated COPD.   "
157182|NCT01226329|"     The Right Question Project-Mental Health (RQP-MH) is a three-session health education     intervention that teaches clients to participate effectively in mental health care. The     methodology teaches clients to identify important issues of their illness or treatment,     formulate questions, and devise plans to communicate and act in effective ways that address     factors impacting their mental health care, with the expectation that this behavior will     increase patient-provider communication and improve the therapeutic alliance between patient     and provider.      The investigators hypothesize that participants receiving the intervention will be more     likely to engage and remain in mental health care, and that they will report higher     activation and self-management scores as compared to control patients.   "
157184|NCT01226303|"     This study is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who     are PCR positive for the PML-RARα transcript or rarer retinoid sensitive subtypes (i.e.     NPM-RAR-alpha, NuMA-RARalpha) and less than 21 years of age (for AIEOP, see appendix A).   "
157185|NCT01226290|"     The primary objective of this study is to establish the effectiveness and confirm the safety     of the VizAblate System in ablating symptomatic uterine fibroids.   "
157186|NCT01226277|"     This is an open-label, multicenter, Phase I dose-escalation study designed to assess the     safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory solid     tumors or lymphoma.   "
157187|NCT01226264|"     Uterine cervical cancer is the second most common female malignancy. Therapy monitoring is     essential to detect early recurrence. Diffusion-weighted magnetic resonance imaging is an     emerging MRI imaging technique which has a potential value for the detection of primary and     recurrent disease and for the assessment of response to therapy. The purpose of this project     is to evaluate the predictive value of DWI during and after therapy in the prediction of     recurrence of cervical uterine cancer. It will be considered whether DWI is able to provide     early information about the response to therapy. This could enable the identification of     less- or non-responsive tumors and in this way therapy can be adapted as soon as possible.     Hence the investigators could offer the patient a more efficient treatment scheme and a     reduction in toxicity related to the treatment could be established.   "
157327|NCT01224418|"     This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid     Arthritis patients who showed unsuccessful response against methotrexate.   "
157188|NCT01226251|"     This study will assess the ability of a first prototype (strip) of a new chair side test to     detect oral malodour. The strip is based on a new enzymatic reaction able to detect amines in     saliva. Previous studies already showed significant correlations between oral malodor and the     levels of amines in saliva. The limitation in their use as markers of oral malodour is the     fact that the detection is usually carried out by complex techniques (High Performance Liquid     Chromatography(HPLC)and Solid-Phase Micro Extraction-Gas Chromatography/Mass Spectrometry     (SPME-GC/MS)). The results of the new enzymatic reaction can be evaluated by means of a     colorimetric scale without necessity of extra apparatus.      The study will be carried out with volunteers recruited at a multidisciplinary consultation     for bad breath, organized at the University Hospital Leuven, Belgium.      The paper strip will be used before the routine evaluation (organoleptic score (OS), the gold     standard method for the diagnosis of halitosis and the level of volatile sulphur compounds     (VSC), the most used adjunct tool to diagnose halitosis).      The results of the new chair side test (strip) will be correlated with the OS and VSC     measurements (OralChroma™, Halimeter®). The sensitivity, specificity and positive and     negative predicted values of the new chair side test will be calculated. The cut-off values     for a yes/no test will be determined. The meaning of color scores will be analyzed to assign     a meaningful outcome to each score with relation to odor intensity.   "
165842|NCT00005650|"     OBJECTIVES:      I. Characterize the clinical presentation of patients with primary ciliary dyskinesia.      II. Identify the genetic mutations associated with this disease.   "
157190|NCT01226225|"     Cardiac rehabilitation, including physical training, has become accepted treatment following     myocardial infarction, coronary stent implantation and coronary bypass operation. Besides     modifying patients' risk profile for future coronary problems, the focus is on improving     exercise capacity. The ability to be able to perform at a higher maximal level is a strong     predictor for outcome (new cardiovascular events and mortality). The main purpose of this     study is to evaluate whether aerobic interval training outweighs more classical moderate     endurance training in improving exercise capacity. During interval training, patients perform     exercise at high intensity, but for only a couple of minutes and then recover at a lower     intensity. Such intervals are repeated. Preliminary evidence from smaller studies suggests     that this type of training leads to a larger increase in exercise capacity, compared to the     more traditional endurance training at moderate intensity.      In addition, mechanisms that might explain how this improvement is achieved, as well as     safety and impact on quality of life will be studied.   "
157191|NCT01226212|"     The objectives of this study are to use a nutritional change in the diet to improve gut     health in older people. Ageing can result in major changes in the composition and activities     of the bacteria in your gut, leading to a higher incidence of gastrointestinal infections,     decreased intestinal motility and impaired bowel function as people get older. This can     result in constipation or diarrhoea, increased levels of inflammation and reduced immune     response to infection. Therefore, individuals aged 65 or over could benefit from safe and     effective interventions that maintain a healthy balance of gut bacteria as well as restoring     the immune response. Bacteria in the gut are known to promote health. Eating foods containing     beneficial bacteria for example (probiotics) or food which contain substrates for the     bacteria to grow on (prebiotics) can improve the balance of gut bacteria. The investigators     will use a synbiotic with known anti-inflammatory properties, comprising a probiotic     Bifidobacterium longum strain and inulin (Synergy 1), The synbiotic has been previously shown     to be beneficial in reducing inflammation and to increase levels of beneficial bacteria in     the gut in two studies in patients with inflammatory bowel disease. The investigators would     now for these reasons, like to determine the effects of our Synbiotic on the gut bacteria and     immune function of older individuals in a double-blinded, crossover, placebo controlled,     randomised investigation involving 40 volunteers for three months. The trial is designed so     that participants will be assigned to receive the Synbiotic preparation or the placebo for     the first four weeks, this will be followed by four weeks without treatment, and then they     will switch to the opposite preparation for another four weeks.   "
157192|NCT01226199|"     Smoking is the most important risk factor of COPD, but only a fourth of smokers had COPD in     their life. There are also healthy smokers without evidence of COPD. Investigators     hypothesize that innate immunity may affect this difference between COPD patients and healthy     smokers, because TLR4 is the receptor of LPS, which is the one of important substance in     cigarette. Investigators will measure TLR2 and TLR4 expression in lung tissue of patients     whose lung will be resected. Investigators will compare the level of expression between COPD     patients and healthy smokers.   "
157193|NCT01226186|"     The study aims to compare two post operative pain management strategy's, traditional nurse     dispensed pain control versus patient self medication. The investigators aim to establish if     patients who self medicate have differing pain levels than those who take nurse dispensed     oral morphine.   "
157194|NCT01226173|"     The purpose of the study is to screen blood donors for the presence of NS1 antigen of the     dengue virus at the American Red Cross in Puerto Rico region (and Monroe County, Florida)     using the Platelia Dengue NS1 Ag enzyme immunoassay.   "
157195|NCT01226160|"     This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative     face-down positioning on the outcome of macular hole surgery.   "
157196|NCT01226147|"     An open-label study to evaluate the efficacy and safety of orally administered Tamibarotene     to patients of Lupus Nephritis   "
157209|NCT01225978|"     The clinical use of genetic testing is expanding and, as a result, the number of variants     identified in patients is growing. Knowledge of the clinical impact of these variants     improves over time. However, the combination of more testing and the rapid evolution of     genetic knowledge make it impossible for clinicians to fully account for the latest     implications of their patients' genetic profiles as patient care decisions are made. This     proposed study plans to enhance and evaluate IT infrastructure developed to provide timely     genetic variant updates and patient search functionality to clinicians to assist in     optimizing patient care.   "
157197|NCT01226134|"     Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor     abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal,     hypersensitivity of the afferent nerves of the gut, psychological disturbances and central     nervous system dysfunction have been proposed.      Pharmacological treatments for patients with functional dyspepsia remain unsatisfactory. Only     small benefits relative to placebo have been found with histamine H2 receptor antagonists,     proton pump inhibitor and Helicobacter pylori eradication.      Itopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent is     currently indicated for patients with various upper GI symptoms.      This study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic     acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking     test)and symptoms in FD patients   "
157198|NCT01226121|"     The purpose of this study is to determine if of manipulation of digits following collagenase     injection for treatment of Dupuytren's contracture is effected by the amount of time between     injection and manipulation.   "
157199|NCT01226108|"     OBJECTIVES:      Primary Objective The primary objective will be a decrease of inconvenience with at least 10%     for at least 50% of the subjects.      Secondary Objectives      The secondary objective will be to:      To evaluate if the patch can improve the tinnitus patient's quality of life and sleep     quality.      METHODOLOGY      Study Design:      An open safety and performance clinical investigation of the antinitus patch in patients with     manifested tinnitus.      Treatment Duration:      1 patch per day for 3 weeks      Primary Endpoint:      Tinnitus severity questionnaire (TSQ)      Performance Parameters:      Tinnitus severity questionnaire (TSQ) and numerical rating scale (NRS) measuring tinnitus     annoyance.      Quality of life and sleep quality      Safety Parameters: Adverse Reactions   "
157201|NCT01226082|"     tDCS is a noninvasive brain stimulation technique that utilizes low amplitude direct currents     applied via scalp electrodes to modulate the level of cortical excitability.Several studies     have demonstrated that tDCS applied over the sensory-motor cortex has been able to decrease     pain sensation and to increase pain threshold in healthy subjects and in chronic pain     patients. The aim of this study was to test whether daily sessions of anodal tDCS repeated     for 5 consecutive days may be effective in reducing pain in a large number of chronic pain     patients. The cathode is usually applied over the right forhead above the eye. The aim of the     study is to test whether daily sessions of tDCS repeated for 5 consecutive days will     influence on ophthalmologic parametrs.   "
157202|NCT01226069|"     The aim of the interventional study is to compare the different treatment modalities in     reducing erythema size and rate of resolving phlebitis.   "
157203|NCT01226056|"     Sorafenib is an oral multikinase inhibitor and among its targets are several RTKs involved in     tumor genesis (Raf, Flt-3, c-Kit and RET) and angiogenesis (VEGFR1, 2 and 3 and PDGFRß).     Therefore sorafenib inhibits tumor growth by a dual mechanism, acting either directly on the     tumor (through inhibition of Raf and Kit signaling) and/or on tumor angiogenesis (through     inhibition of VEGFR and PDGFR signaling.      RAD001 is a novel derivative of rapamycin. It selectively inhibits mTOR directly blocking     tumor cells by preventing tumor cell growth and proliferation and indirectly by inhibiting     angiogenesis (via potent inhibition of the HIF-1 and consequently VEGF production).      Targeting mTOR in combination with sorafenib might lead to more profound effects on tumor     cell biology than could be achieved through individual targeting of some proteins.      New drugs have often met only limited success since not always target pathways responsible     for tumor development and growth are targeted. To overcome this problem, the specific     pathways targeted by the investigators two drugs will be analyzed in each single patient     before the inclusion.   "
157204|NCT01226043|"     Primary Objective:      To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the     end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM)      Secondary Objectives:      To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following     parameters:      Randomization/Crossover phase:        -  Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus          vial and syringe      Re-randomization phase:        -  Change in Fasting Plasma Glucose (FPG) from week 4 to week 10        -  Percentage of patients achieving FPG<110 mg/dL at week 10        -  Change in Lantus dose injected per day (U) from week 4 to week 10      Observational phase:        -  Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (<7%) at week 40        -  Time to first observation of HbA1c<7% during the observational phase        -  Percentage of patients who discontinue Investigational Product (IP) during the          observational phase due to dissatisfaction with their current device      All phases:        -  Percentage of patients who discontinue IP during each phase of the study        -  Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events (AE)   "
157205|NCT01226030|"     This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With     Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES     will be selected to perform the pharmacokinetic study profiles.   "
157206|NCT01226017|"     The purpose of this pilot study is to investigate the possible change of Oxytocin level in     human blood after positive interaction with farm animals.   "
157207|NCT01226004|"     To address pertinent questions regarding the utilization of stereotactic Body Radiotherapy     (SBRT) to treat prostate cancer. The Florida Robotic Radiosurgery Association (FRRA) launched     the first registry for prostate cancer patients treated with SBRT. The registry is designed     to track surrogate treatment endpoints including prostate specific antigen (PSA),     international prostate symptom score (IPSS),sexual health in men (SHIM), and visual analogue     scale (VAS) scores, in addition to physical and survival data. Utilizing an independent     vendor (Advertek, Inc.) experienced with the design and implementation of similar electronic     registries, FRRA developed a data collection tool that staff members with a basic medical     background can use to register and upload pertinent patient data, requiring no more than 20     to 30 minutes per patient. Participating patients will be monitored in follow-up for three     years, with analysis and publication of the results semi-annually.   "
157211|NCT01225952|"     The objective of this study is to compare the contrast sensitivity, high and low contrast     visual acuity (VA), glare meter outcomes, and subject satisfaction with three different     FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near     vision following lens extraction in adults at least 40 years of age.   "
157212|NCT01225939|"     A study conducted over 3 periods to look at the drug in the body.   "
157213|NCT01225926|"     The purpose of this study was to evaluate and compare uncorrected distance visual acuity     measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric     Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.   "
157214|NCT01225913|"     The purpose of this study is to evaluate the site and mechanisms responsible for expiratory     airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to     severe persistent expiratory airflow obstruction. Treatment will include inhaled     corticosteroids and long acting beta2agonists. The investigators are interested in     determining whether the large and/or small airways are the predominant site of airflow     limitation. The investigators are also interested in determining whether intrinsic small     airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow     limitation. The investigators are also interested to evaluate the role of varying doses of     inhaled corticosteroids to suppress large and small airway inflammation using exhaled nitric     oxide as surrogate markers of inflammation. For comparison purposes, spirometry and     measurements of exhaled nitric oxide will also be obtained if possible during a naturally     occurring exacerbation of asthma.   "
157215|NCT01225887|"     This phase II trial studies the side effects and how well nintedanib works in treating     patients with endometrial cancer that has come back. Nintedanib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the     tumor.   "
157304|NCT01224717|"     This study is designed to provide information about the bone-anabolic response of PTH134 when     administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the     active ingredient in PTH134.   "
157216|NCT01225874|"     RATIONALE: Studying samples of blood or bone marrow from patients with cancer in the     laboratory may help doctors predict how well patients will respond to treatment. Drugs used     in chemotherapy work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Giving more than one drug (combination     chemotherapy) may kill more cancer cells.      PURPOSE: This trial is studying biomarkers to classify young patients with acute     lymphoblastic leukemia (ALL) and remission induction therapy in young patients with     B-precursor ALL.   "
157217|NCT01225861|"     The primary objective of the study is the descriptive analysis of incidence & severity of     side effects & reasons for discontinuation of the treatment of chronic pain with transdermal     analgesic Buprenorphine patches.   "
157218|NCT01225848|"     This is a randomized Blinded Phase II trial of Maintenance SU011248 Versus Placebo Post     Chemotherapy for Patients With Advanced Urothelial Carcinoma.   "
157219|NCT01225835|"     This study is aimed to demonstrate that highly purified Menotrophin produces significant     lower progesterone serum levels during the follicular phase in comparison to Follitropin     alpha in the treatment of subfertile females undergoing an in vitro fertilisation (IVF) and     to investigate if the progesterone serum levels might be a useful predictor for the success     rate of the ongoing pregnancy rates   "
157220|NCT01225822|"     The primary objective of this study is to establish the dose-response relationship with     regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg     b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients     undergoing primary elective total hip and knee replacement.   "
157221|NCT01225809|"     Patients who were vaccinated with AFFITOPE AD01 during AFFiRiS001 will undergo a long-term     follow-up period to get more information regarding the safety profile of AFFITOPE AD01.   "
157222|NCT01225796|"     The purpose of this study is to compare the effect of sodium bicarbonate versus no sodium     bicarbonate treatment on urinary ammonia levels and urinary transforming growth factor-beta1     (TGF-beta1) excretion in renal transplant patients with low-to-normal serum bicarbonate     levels (20 - 28 mmol/L).   "
157223|NCT01225783|"     Lymphedema is a common, chronic, side effect resulting from the treatment of breast     cancer.Insufficiency in the lymphatic system causes edema in the upper limb. The accepted     conservative treatment is based on the anatomy and physiology of the lymphatic system. The     aim of the treatment is to reduce the volume of the upper limb by, initial, intensive     treatment and then to keep the arm volume at this reduced level.The measurement of limb     volume involves measuring the circumference of the arm at defined points and then with the     use of a formula the volume of the arm can be calculated. After intensive therapy is complete     the responsibility for measuring limb volume moves to the patient. This study will examine     the reliability and validity of self measurement of limb volume. The investigators will     compare the results of self measurement using the accepted plastic tapemeasure against a     paper tape measure adapted for self measurement.Both methods will be compared to the gold     standard volume displacement. In the study there will be two meetings with the subjects where     the patient and physiotherapist will use the three methods.   "
157224|NCT01225770|"     Experimental and clinical studies in adults have reported that green tea catechins prevent     influenza infection. In this clinical randomized study, the investigators aimed to determine     the effects of gargling with green tea on the prophylaxis of influenza infection among high     school teenagers.   "
157225|NCT01225757|"     Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) is performed in     patients with peritoneal tumors. Classically, this procedure is prolonged in duration and     involves significant fluid shifts. Patients receive a large amount of volume replacement     during this procedure (between 10 and 20 liters). The traditional methods to monitor adequacy     of volume replacement are measurement of urine output and central venous pressure. There are     drawbacks of any method of intravascular volume status measurement which may lead to over or     under replacement of fluids. If fluid replacement is underestimated, the patient may suffer     from adverse effects such as hypotension and renal dysfunction. However, the excessive     administration of fluids may lead to other adverse events, including cardiac dysrhythmias and     heart failure. The hypothesis of this study is that patients in whom volume status is     maintained by utilizing a transesophageal echocardiogram will have better maintenance of     fluid status while avoiding intravascular volume overload.   "
157328|NCT01224405|"     The study includes the recruitment of patients with advanced prostate cancer resistant to     chemical castration This is a multicenter prospective trial randomized phase III   "
157226|NCT01225744|"     A Phase II trial to demonstrate the response rate, using the Response evaluation criteria in     solid tumours (RECIST) criteria, of patients with locally advanced / metastatic colorectal     cancer treated with combination of irinotecan, oxaliplatin, UFT and cetuximab.      ENDPOINTS Primary: Objective response rate (RECIST) Secondary: Progression free survival     (PFS), Overall survival (OS) Toxicity (CTCAE), Resectability of liver, lung and pelvic     disease after chemotherapy, Time to progression (TTP).      POPULATION: The trial aims to recruit 50 patients with inoperable, metastatic colorectal     cancer ELIGIBILITY: Histologically confirmed colorectal adenocarcinoma Normal haematology and     adequate renal and liver function Written informed consent and able to attend follow-up for     at least 3 months TREATMENT 4 weekly cycles of chemotherapy with alternating irinotecan (day     1) and oxaliplatin(day 15). Cetuximab every 2 weeks and oral UFT with Leucovorin for 3 weeks     every 4 weeks.      DURATION First patient recruited April 2009. Accrual to take place over 24 months Follow-up     will continue until death or for a minimum of 3 years   "
157227|NCT01225731|"     This is a response-driven study of tildrakuzumab for the treatment of moderate to severe     chronic plaque psoriasis. The primary study hypothesis is that one or more doses of     tildrakizumab will be superior to placebo for the treatment of psoriasis.   "
157228|NCT01225718|"     This is a retrospective chart review of all patients cared for at Monroe Carell Jr.     Children's Hospital at Vanderbilt including the following:        -  patients between 2007-2009 with malignancy, Langerhans cell histiocytosis (LCH) or          hemophagocytic lymphohistiocytosis (HLH) and a central venous catheter who were under 23          years of age at time of diagnosis in order to ascertain the associated symptoms,          management and outcome of all episodes of non-neutropenic fever.        -  to identify a subset of low-risk patients that can be safely managed without use of          empiric antibiotics.   "
157229|NCT01225705|"     Current European AIDS Clinical Society (EACS) guidelines for the treatment of HIV infection     recommend a combination antiretroviral regimen composed of two nucleoside reverse     transcriptase inhibitors plus a ritonavir boosted protease inhibitor or a non-nucleoside     reverse transcriptase inhibitor.      The non-nucleoside reverse transcriptase inhibitors licensed for naïve patients - nevirapine     and efavirenz - have both been asociated with increased rates of hepatotoxicity (nevirapine)     and CNS toxicity (efavirenz) in HIV/HCV co-infected patients. Although PI-based therapy has     dramatically reduced morbidity and mortality, it has been limited by complex dosing regimens     and toxicities, leading to adherence challenges. Varying degree of liver insufficiency may     necessitate pharmacokinetic monitoring of the protease inhibitor and may necessitate dose     adjustments. In HIV/HCV co-infected patients HAART based on another class of antiretrovirals     than NNRTI or PI may thus offer advantages with regard to adverse events and thus long-term     efficacy.      The overall intention of this trial is to examine in a non-inferiority design the safety and     efficacy of a raltegravir based HAART with a standard-of-care HAART in HIV-/HCV co-infected     patients. The standard of care used in this study will be atazanavir/ritonavir. All patients     will in addition receive a fixed combination of tenofovir and emtricitabine.      The primary end-point is the rate of hepatotoxic events, defined by ALT elevations.   "
157230|NCT01225692|"     The goals of this study are to identify outcome indicators of optimal care for brain injury     patients, including pre-hospital care, prompt delivery to neurosurgical care and access to     early rehabilitation services. Nova Scotia's centralized Neurosurgical services and     integrated provincial Emergency Health Services provide a rich opportunity to construct a     cohesive, integrated data management system. This system will allow us to answer important     research questions related to the outcomes, care and prevention of brain trauma.      Retrospective data collection The retrospective arm of the BTO study has created full data     sets and care pathways from multiple sources covering the continuum of brain trauma care.     Investigators continue to analyze this large amount of data and prepare it for publication.      Prospective data Collection Patients with a major head injury (initial GCS 3-12), have been     considered for enrollment in the BTO study.The prospective arm of the BTO study has 52     patients enrolled. Screening and Enrollment was complete on June 30, 2007. These patients are     participating in long term follow up at 6, 12 and 24 months post injury for assessment of     qualitative and quantitative outcomes. Completion of patient follow up will be in June 2009.   "
157231|NCT01225679|"     Congenital central hypoventilation syndrome (CCHS) is a rare disorder of respiratory control     characterized by ventilatory impairment that results in arterial hypoxemia. Although patients     typically present this disease as newborns and rarely in later infancy, there have been     reports of patients presenting with CCHS in adulthood.      The present study reports a unique familial case in which the father (proband) presented     late-onset CCHS with an expansion mutation of the Phox2B gene that was confirmed by genetic     analysis. Surprisingly, the proband did not report any manifestation of the disease during     childhood, and the disease progressed following an insidious course until adulthood. At the     time of diagnosis, he did not present signs of pulmonary hypertension and right-side heart     failure. The patient responded well to nocturnal invasive ventilation. In contrast, his son     presented CCHS as a newborn with the full complement of symptoms while his daughter did not.      The present report shows that CCHS cases characterized by a mutated Phox2 gene can progress     without many symptoms and that the treatment approach used here was efficient for controlling     the course of the disease. Furthermore, this case indicates that incomplete penetrance can     occur. Genetic screening of family members is mandatory to evaluate the reproductive risk of     the disease, especially because asymptomatic mutation carriers may be at high risk to develop     the disease and transmit it to the next generation.   "
157232|NCT01225666|"     This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics     (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an     every-other-week regime administered for a period of 4 weeks in Growth Hormone Deficient     Adult (GHDA) patients who previously were on a stable r-hGH treatment. An additional     extension period of 16 weeks once-weekly administration of MOD-4023 aims to confirm the dose     selection for future trials.   "
157233|NCT01225653|"     Randomized double-blinded two-year intervention study with topical application of latanoprost     or placebo eye drops in patients with diabetic retinopathy.   "
157234|NCT01225640|"     PNU-100480 is being developed for the treatment of both drug resistant and sensitive     tuberculosis. This is an efficacy and safety study to characterize the effect of PNU-100480     when given for 14 days to treatment-naive patients with drug-sensitive pulmonary     tuberculosis.   "
157235|NCT01225627|"     This is a single-centre randomized controlled clinical trial which will enroll COPD patients     in Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV, hospitalized     due to acute exacerbation. Patients will be randomised in a 1:1 fashion to intervention     group, which will have care organized by discharge coordinator, and control group which will     receive care as usual. The primary endpoint of this study is time to hospitalization due to     COPD worsening. Data will be collected at baseline, at the time of hospital discharge, and at     following time-points after the hospital discharge: 48 hours, 7-10 days, 30 days, 90 days,     and 180 days.   "
157236|NCT01225614|"     This is a multicenter randomized controlled open labeled study testing efficacy and tolerance     of early launching of night non invasive ventilation in patients with myotonic dystrophy type     1(DM1). The object of this project is to estimate the effects of the early introduction of     non invasive ventilation on the arisen of complication (non expected hospitalization,     tracheostomy even death) with regard to a simple respiratory follow-up in patients affected     by myotonic dystrophy.   "
157237|NCT01225601|"     Study objectives:        -  To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell          histiocytosis        -  To assess the impact of tobacco discontinuation        -  Study Design Multicentric prospective cohort study        -  Main endpoint: Pulmonary deterioration        -  Sample size : 40 patients   "
157330|NCT01224379|"     Does a new topping-off device lead to a better clinical outcome compared to standard     fusion? Does this device prevent the development of adjacent instability? Does radiological     adjacent instability correlate with clinical outcome?   "
157331|NCT01224366|"     To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients     with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.   "
157238|NCT01225575|"     This is a prospective, randomised, open label, multicentre Phase II clinical trial to     investigate the efficacy and safety of the treatment of large defects with 3 different doses     of the autologous chondrocyte transplantation product co.don chondrosphere® (ACT3D-CS) in     subjects with cartilage defects of the knee.      After screening visit patients were booked for arthroscopy and had their cells harvesting     from healthy cartilage. After the arthroscopy the patients were randomised in one of the     three dose-groups. The cells are cultivated for 8-10 weeks in vitro to develope 3-dimensional     spheroids, that are transplanted in an open knee procedure (treatment surgery)into the     defect. Patients of all dose groups subsequently followed the same rehabilitation program and     had post-surgery visits. The 12-month-visit is defined as final assessment. Then patients     have follow-up assessments up to 60 months.   "
157239|NCT01225562|"     This study is being carried out to see if a new drug called ticagrelor given twice daily in     addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death     from heart disease, heart attack, or stroke).   "
157240|NCT01225549|"     The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma     challenged with an inhaled allergen.   "
157241|NCT01225536|"     This is an open-label, Phase 1, dose escalation study of oral ARQ 736 administered to     subjects with advanced solid tumors harboring the mutation. The study is designed to explore     the safety, tolerability, pharmacokinetics and pharmacodynamics of ARQ 736 and to define a     recommended Phase 2 dose of ARQ 736.   "
157242|NCT01225523|"     To assess whether or not a perioperative therapy with surgery can improve the outcomes among     patients with potentially curable squamous carcinoma of esophagus as compared to a     preoperative chemotherapy followed by surgery   "
157243|NCT01225510|"     Angiopoietin-2 (Ang-2) is a protein in the body which destabilizes blood vessels and is     important in stimulating tumor blood vessels. There is evidence suggesting that Ang-2 may be     important for the growth and progression of Glioblastoma multiforme (GBM). PF- 04856884     (CVX-060) is a compound which binds Ang-2 and prevents its activity. The hypothesis is that     PF-04856884 will be safe and effective in patients with recurrent Glioblastoma multiforme     (GBM).   "
157244|NCT01225497|"     Chronic pain and disability are unfortunately common in Achilles tendon pain. Outcome after     surgery is often poor. Also tendon pain can be resistant to treatment and may lead to     cessation of hobbies or careers.      Recently eccentric exercise (defined as muscle loading where tension develops as physical     lengthening occurs) has become a cornerstone in managing tendon pain due to an increasing     amount of favorable research. Eccentric exercises are considered to be non-invasive, safe,     and appear to be important for a successful outcome.      One exercise program has been extensively adopted in research and clinical practice for     Achilles pain. It recommends individuals perform 180 repetitions a day. However there appears     to be little scientific rationale for this number. Consequently there may be significant     implications for patient compliance, satisfaction, and overall treatment efficacy in a     strategy which is encouraged to be uncomfortable.      Fifty two adults (18-70 years old), with mid-Achilles tendon pain will be randomised to     standard treatment (180 repetitions) or to a group where individuals are allowed to do what     they can. Participants will be recruited from participating physiotherapy departments (health     centres and hospital departments) across NHS Forth Valley. All individuals will be required     to complete the same type of eccentric exercise for six weeks attending an initial assessment     and two follow-up appointments at three and six weeks. Thereafter participants will be     discharged if better, or continue with individual care where appropriate.      It is hoped this pilot study will establish if future larger scale investigation is warranted     examining whether it is necessary to subject individuals to 180 repetitions a day in an     activity recommended to be uncomfortable. Also will participant satisfaction differ between     exercise groups? If further investigation is warranted this pilot may provide population     specific data for future sample size calculations, and may provide a suitable methodology for     such investigations.   "
157245|NCT01225484|"     The purpose of this study is to compare two accepted methods of pain control in knee     arthroplasty surgery.The first method combines the periarticular injection of ropivacaine     with continuous blockade of the femoral nerve.The second method uses periarticular     infiltration of ropivacaine in combination with an bolus of ropivacaine into an     intraarticular catheter placed intraoperatively followed by a continuous intraarticular     infusion of ropivacaine. All patient will also receive a sustained-release oral opioid and     oral rescue opioids determined by pain severity using the Visual Analog Scale (VAS)   "
157246|NCT01225471|"     The purpose of this study is to evaluate the safety and clinical efficacy of novel peptide     vaccination for advanced prostate cancer   "
157247|NCT01225458|"     The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly     patients aged over 75 years with renal insufficiency stage 5 will be included in the study     after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in     the exclusive nephrology follow-up arm will continue their usual follow-up; 250 patients in     the geriatric follow-up arm will have both their usual nephrology follow-up and a geriatric     follow-up.      The aim of the study is to determine if a systematized gerontologist evaluation delay the     occurrence of a composite primary endpoint : death, dementia, depression and severe     dependency. The hypothesis is that the functional and vital prognosis of a patient with renal     insufficiency depends not only on common and classical factors but also on cognitive and     psychological functions and dependence, particularly in elderly patients.   "
157248|NCT01225445|"     Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in     the world. The treatment of IgA nephropathy with normal renal function and minimal     proteinuria is unknown. Since angiotensin-converting enzyme (ACE) inhibitors reduce     proteinuria and retard the rate of decline of renal function in chronic proteinuric     nephropathies, including IgA nephropathy. The investigators conduct a randomized control     study to evaluate the efficacy of ACE inhibitor in the treatment of early IgA nephropathy.     Sixty patients with biopsy-proven IgA nephropathy and minimal proteinuria are recruited. They     will be randomized to ramipril for 5 years or no treatment. Blood pressure, proteinuria and     renal function will be monitored. This study will explore the effects of ACE inhibitor in the     treatment of early IgA nephropathy, which is a major cause of dialysis-dependent renal     failure.   "
157249|NCT01225432|"     To assess the carryover effect of an innovative new gait training program on physiological     and functional gait performance in persons with a traumatic lower extremity amputation. A     second objective is to clarify the relationship between gait biomechanics (joint and sgment     kinematics and energy cost.   "
157250|NCT01225419|"     This is a prospective Phase II, monocentre study.   "
157332|NCT01224353|"     The purpose of the study is to evaluate the efficacy on overall neuropathic sensory symptom     improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in     Chinese diabetic patients with distal symmetric polyneuropathy (DSP).   "
157251|NCT01225406|"     This is an observational cohort study of virologic and immunologic outcome after at least 48     weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be     enrolled. Third line antiretroviral therapy in this study is defined as an antiretroviral     (ARV) regimen in a patient who has failure or intolerance to first line NNRTI-based therapy     and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as     darunavir, tipranavir, etravirine and raltegravir The knowledge gained from this study will     help the Thai government in planning its strategy to provide third line ARV therapy to     children within the national program.   "
157252|NCT01225393|"     This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter     study enrolling patients with active rheumatoid arthritis (RA).   "
157253|NCT01225380|"     This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of     response-guided duration of therapy with GS-9190 and GS-9256 in combination with     Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and     safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and     Ribavirin (Copegus®) will be evaluated.   "
157254|NCT01225367|"     The study is a prospective open evaluating study of Ultrasound/Doppler application to the     chest cavity intended to detect and characterize pathologies of the pulmonary and     cardio-vascular system.      The system is a noninvasive non-imaging device designated to monitor flow and movement     velocity and display the data continuously.   "
157255|NCT01225354|"     The purpose of this study is to determine if Radiesse injections to the cheeks result in an     altered and improved first impression and self esteem.   "
157256|NCT01225341|"     The purpose of this study is to determine the efficacy and safety of Botulinum Toxin Type A     as a preventative measure for Herpes Labialis.   "
157257|NCT01225328|"     This project will develop and preliminarily evaluate an intervention to assist young-middle     adult rural breast cancer survivors to overcome functional impairments related to their     cancer treatment. Younger breast cancer survivors (below age 60) have ongoing family, social     and vocational responsibilities and recreational interests and are at increased risk of     developing long-term difficulties performing these valued activities (participation     restrictions). Rural cancer survivors are medically underserved and due to distance and     geographic isolation face significant barriers to accessing traditional rehabilitation     services. Alternative rehabilitation approaches are sorely needed for this population. Based     on previous research with cancer and other medical populations a working draft of a treatment     manual using a telephone-delivered Behavioral Activation and Problem Solving (BA/PS)     intervention has been designed. Prior to testing the intervention in a randomized clinical     trial, additional work must be completed. The specific aims of this study are to a. refine     the BA/PS treatment manual, b. develop and apply treatment integrity measures for the BA/PS     manual, c. assess participation restrictions and associated outcomes, d. preliminarily assess     the immediate and maintenance effects of BA/PS, and e. examine mediators and moderators of     BA/PS effects based on our Self Regulation model of functional recovery. 188 young-middle     adult breast cancer survivors will be screened for participation restrictions following     cancer treatment and 40 survivors with participation restrictions will receive BA/PS     delivered by phone. BA/PS participants will be assessed for treatment effectiveness and     interviewed regarding their experiences during treatment to provide information for refining     the manual. The long-term objective of this line of research is to develop effective and     feasible treatments for the medical and psychosocial consequences of cancer and its treatment     in medically underserved cancer survivors (e.g., rural populations).   "
157258|NCT01225315|"     This study will assess the efficacy and safety of ACT-129968 in subjects with partly     controlled asthma on reliever therapy only.   "
157259|NCT01225302|"     The primary objective of this study is to assess the safety and pharmacokinetics of     linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin     and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer     (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in     the subjects as first-line treatment.   "
157260|NCT01225289|"     The aim of this study is to study the comparison between the effects of supplementation with     25000 IU preformed vitamin A (retinyl palmitate) or placebo for 6 months on immune system and     Th1/Th2 balance in patients with Multiple Sclerosis.   "
157261|NCT01225276|"     NewGam (current working title for a new IGIV formulation) is a newly developed human normal     immunoglobulin solution ready for intravenous administration (IGIV). This study will evaluate     the safety and efficacy of three different dosages of NewGam 10% in patients with Chronic     Inflammatory Demyelinating Polyradiculoneuropathy.   "
157262|NCT01225263|"     The investigators are studying if taking simvastatin and vitamin D together will help prevent     episodic migraines. Simvastatin is an FDA approved drug that is typically used to treat high     cholesterol and reduce the risk of stroke and heart attack. Vitamin D is a vitamin found in     certain foods like some types of fish, and in nutritional supplements. This study is 9 months     long. Some people who participate will receive simvastatin and vitamin D, and some people     will receive a placebo. A placebo is a sugar pill that looks like medication but does not     have any active ingredients in it.      The investigators hypothesize that taking vitamin D and simvastatin daily may reduce the     number of migraines people who have episodic migraine get.   "
157263|NCT01225250|"     The purpose of this study is to determine efficacy, safety, and ease of cartilaginous     grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as     performed through an endonasal rhinoplasty approach in patients requiring a caudal septal     extension (CSE) graft.   "
157264|NCT01225237|"     A study to verify the superiority of ramosetron hydrochloride (Irribow Tablets) to placebo     for male patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate     its safety.   "
157268|NCT01225185|"     Neurological injury after elective shoulder surgery in the beach chair position is thought to     result from cerebral hypoperfusion and should therefore be preventable by appropriate     hemodynamic monitoring and management. This proposal will use a system to continuously     monitor cerebral blood flow autoregulation to identify safe arterial blood pressure targets     in patients in the beach chair position, compared with a control cohort having orthopedic     surgery in the lateral decubitus supine position. Autoregulation data will be compared     against a new, highly specific and sensitive serum biomarker of neurologic injury, glial     fibrillary acid protein, and postoperative neurocognitive testing results.   "
157269|NCT01225172|"     The purpose of this study is to evaluate oral doses of BMS-754807 in combination with     letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic     hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal     aromatase inhibitor treatment.   "
157270|NCT01225159|"     To determine whether intraoperative tight glycaemic control can reduce postoperative     infection, morbidity and mortality   "
157274|NCT01225107|"     Bacterial infections are a common complication in patients suffering from burns. These     infections can cause significant morbidity and often mortality. Antimicrobial resistance     coupled with the prevalence of burn-related infections warrants the identification of     alternative substances in the treatment of burn-related infections. The cranberry has been     examined as a potential agent in the prevention of other types of infections and it appears     to have anti-adherence effects on bacteria. In addition, the cranberry has demonstrated     general inhibitory effects against some types of bacteria suggesting that it may be a useful     agent in the prevention of bacterial infections in burn patients. The purpose of the present     study is to investigate the effect of cranberry extract on the incidence of infections in     burn patients.   "
157275|NCT01225094|"     The purpose of this program of research is to determine whether curcumin, a natural health     product, can prevent acute kidney injury and other complications after elective AAA repair.     If proven safe and effective, curcumin is an inexpensive intervention which can be readily     applied to almost 50,000 AAA repairs performed worldwide each year. New knowledge about this     intervention may also guide its use in other surgical and medical settings to prevent     complications to the kidneys, heart and other organs.   "
157276|NCT01225081|"     This study is to evaluate the efficacy and safety after concomitant administration of ASP1941     and pioglitazone in patients with diabetes mellitus.   "
157277|NCT01225068|"     Low back pain is a public health problem affecting between 70-85% of adults at some time in     their life. This study is being done to study the safety and effectiveness of the drug     Milnacipran in treating chronic low back pain.   "
157278|NCT01225055|"     Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the     effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on     bone mass.   "
157279|NCT01225042|"     Background:      The incidence of gastrointestinal infections is very high. In European countries 10-25% of     the population suffers from at least one foodborne infection per year. Probiotics may     strengthen human resistance to gut infections as they may beneficially modulate the     intestinal microbiota composition and activity, and the immune function upon intestinal     infection.      Aim:      To study whether probiotics improve the resistance of humans to enterotoxigenic E. coli     (ETEC).      Study design:      The PRETEC study is a parallel, double-blind, placebo-controled 4-weeks intervention with     probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs     placebo on several infection markers in response to an ETEC challenge is investigated.     Participants will be randomly assigned to the probiotic or placebo group (n=21 per group).     Subjects will be instructed to maintain their habitual food intake, but to standardize their     dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally     infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food     research; dose will be 10E10 CFU). This ETEC strain induces mild and short-lived infectious     diarrhea symptoms. Before and after infection, a diary will be kept to write down all food     and drinks consumption (2x2 days) to assess the habitual dietary intake. The diary will also     be used for daily recording of bowel habits and frequency and severity of gastrointestinal     complaints. Blood is sampled for immune response analyses and multiple faecal samples are     collected to quantify several infection- and immune system markers, to determine probiotic     excretion, and to verify dietary calcium intake.      Study population:      Healthy males of 20-55 yrs of age.      Interventions:      Probiotics (freeze-dried powder, dose 10E9 CFU twice daily) or placebo (carrier material     powder of identical appearance).      Primary outcomes:      Total fecal ETEC excretion per day and severity of diarrhea (quantified by faecal output per     day).      Secondary outcomes:      Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal     complaints, relative faecal wet weight, sIgA and calprotectin in faeces, probiotic     persistence and levels of opportunistic pathogens in the endogenous microbiota.   "
157280|NCT01225029|"     Transient tachypnea of the newborn (TTN) is a diagnosis given to infants born between 34 and     42 weeks gestation who develop difficulty breathing during the first days of life when no     specific cause of the breathing difficulty can be identified. Little is known about why some     babies develop TTN, and there have not been many formal studies of the best way to take care     of babies with this disease. Babies with TTN get better on their own within three to five     days after birth, but may require extra oxygen to breath well.      Most physicians believe that the symptoms of TTN are related to poor clearance of fluid from     the newborn's lungs. Babies with TTN have extra fluid visible on chest x-ray. Diuretics,     medicines that can help clear extra lung fluid in adults and in babies with extra lung fluid     for other reasons, do not to help babies with TTN. Babies with TTN need intravenous fluids to     be healthy because they breathe too fast to be able to eat. Breastfed babies only get a very     small amount of fluid in the first few days of life, as it normally takes several days for a     new mother to begin producing breastmilk. No one has yet examined whether giving babies with     TTN an amount of fluid similar to the small amount they would receive if they could     breastfeed would help them recover from TTN faster.      In this study, the investigators compare whether giving newborns standard intravenous fluid     or amounts of intravenous fluid more close to what a breastfed baby would receive speeds     recovery in newborns with TTN.   "
157281|NCT01225016|"     This study will evaluate thyroid nodules using specialized ultrasound imaging methods.   "
157282|NCT01225003|"     In this study, we evaluate the role of diffusion kurtosis imaging (DKI) and MR spectroscopy     (MRS), two advanced imaging techniques in magnetic resonance (MR) in grading and detection of     microscopic infiltrating tumour in gliomas. These parameters are of utmost importance in     optimal choice and planning of treatment.      Patients treated with gliomatous brain tumours are included voluntarily. They undergo one     imaging session on a 3T MR scanner prior to treatment.      DKI data are quantitively analyzed in order to estimate specific parameters in normal     appearing white matter, grey matter, tumor and peritumoral edema. MRS data are analyzed     quantitatively and qualitatively with peak integration, ratio calculation and classification     algorithms. Histological confirmation is obtained at subsequent surgery.      Information from this study can be of significant importance in avoiding brain biopsies.     Furthermore, information on microscopic tumour spread can be used during neurosurgery or in     radiotherapy planning. An important advantage of these advanced MR techniques is the     non-invasivity and the lack of ionizing radiation, two important issues in this relatively     young patient population.   "
157333|NCT01224340|"     The hypothesis was that an active distraction is more effective than a passive distraction in     conjunction with procedural pain in children. The specific aim in this study was to test how     an active distraction, serious gaming and a passive distraction, the use of lollipops     influence pain, distress and anxiety in children during wound care.   "
157334|NCT01224327|"     The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem     cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.   "
157575|NCT01221129|"     The specific aim of this protocol is to examine differential expression of specific mRNAs and     proteins that occur when the dietary intake of zinc is acutely reduced below the dietary     requirement for a period of ten days.   "
157283|NCT01224990|"     The aim of the study is to assess the value of whole body diffusion weighted MR imaging     (WB-DWI) as a non-invasive method. On one hand for pretreatment lesion detection and     post-therapeutic tumor recurrence but also for early therapy monitoring with the intention to     early identify patients with a poor tumor response. Our research group demonstrated that this     technique is accurate in patients with head and neck cancer it could differentiate between     viable tumor tissue and inflammatory or necrotic tissue at variable time points after     completion of radiotherapy. In the literature it is stated that DWI can also predict the     response to chemotherapeutic therapy. This is only true for focal MRI images (eg only in     liver). This study aims to determine whether the whole body technique can efficiently be used     because the distribution of metastases is systemic. The study includes two phases: In a first     phase, a baseline study will be conducted; all possible injury types will be gathered to     determine the variability in signal characteristics to finally determine appropriate     thresholds to differentiate between benign and malignant lesions. This should allow us later     on to perform prospective studies. In a second phase, different applications such as:        -  pretherapeutic staging        -  Detection of post-therapy recurrence        -  Early evaluation of systemic cytotoxic therapy.      The results of the DW-MRI will be compared with those of PET, CT and conventional MRI which     are now routinely performed for the diagnosis of colorectal tumors. The scans will be     performed in a group of patients on a 3 Tesla MR system. This system is fully approved by the     European and American standards and the patients will not be exposed to radiation or contrast     agents. In principle, all patients treated for gastrointestinal cancer were included after     informed consent from the patient. This study is important to investigate whether DWI is     accurate in the pre-therapeutic injury detection and staging of gastrointestinal tumors     compared with PET / CT and DWI. In addition it is important to predict the outcome after     therapy.   "
157284|NCT01224977|"     The main objectives of the study are:      1. To unravel the importance of molecular phenotyping in predicting the response to     antimicrobial therapy with potential anti-inflammatory potency      The investigators have developed a non-invasive technique based on mRNA analysis of induced     sputum that enables us to study airway inflammation in detail. This technique forms the basis     for our current project based on the following hypotheses:        1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as          reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can          be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.        2. Based on our previous research and preliminary data that non-Th2 asthma can be further          divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2,          Th17 or Th1 characteristics also exist.        3. These subgroups have different responses to anti-microbial therapy with potential          anti-inflammatory potency (macrolides).   "
157285|NCT01224964|"     The main objectives of the study are:      1. To unravel the importance of molecular phenotyping in predicting the response to classical     anti-asthma treatment (leukotriene antagonists)      The investigators have developed a non-invasive technique based on mRNA analysis of induced     sputum that enables us to study airway inflammation in detail. This technique forms the basis     for our current project based on the following hypotheses:        1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as          reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can          be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.        2. Based on our previous research and preliminary data that non-Th2 asthma can be further          divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2,          Th17 or Th1 characteristics also exist.        3. These subgroups have different responses to anti-leukotrienes.   "
157286|NCT01224951|"     The main objectives of the study are:      -to unravel the importance of molecular phenotyping in predicting the response to classical     anti-asthma treatment (inhaled corticosteroids)      The investigators have developed a non-invasive technique based on mRNA analysis of induced     sputum that enables us to study airway inflammation in detail. This technique forms the basis     for our current project based on the following hypotheses:        1. different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as          reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can          be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.        2. Based on our previous research and preliminary data that non-Th2 asthma can be further          divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2,          Th17 or Th1 characteristics also exist. The investigators hypothesize that the          epithelial cell cytokine, TSLP, can be increased as an early marker of airway          inflammation in this latter group.        3. these subgroups have different responses to anti-inflammatory treatment.   "
157287|NCT01224938|"     The main objectives of the study are        1. to study the different T cell subtypes (Th1, Th2, Th17 and Treg) in the lower airways of          healthy subjects and clinically different asthma patients, based on a non-invasive          procedure of sputum induction. Patients will be different in function of age, in          relation to the trigger (eg aspirin, without or with association with polyposis),          without or with underlying atopic sensitization or different in the type of underlying          inflammation (eosinophilic vs neutrophilic). This T cell pattern will become the basis          of molecular phenotyping in the patients.        2. to study the usefulness of asthma molecular phenotyping (by following the balance          between the inflammatory markers on the one hand and the regulatory markers on the other          hand) in asthma guidance (longitudinally).      The final goal of this project is then to develop a sputum non-invasive biomarker array that     can be used to distinguish the different inflammatory asthma phenotypes and that can predict     steroid resistance and/or sensitivity to other anti-inflammatory medication, using a     non-invasive technique that can be used also at young age and repetitively.   "
157288|NCT01224925|"     The purpose of this study is to investigate whether MTA is more effective than a conventional     calcium hydroxide liner (Dycal®) as a direct pulp capping material in mature molar teeth with     a carious pulpal exposure.   "
157289|NCT01224912|"     The object of this study is to determine variables associated with therapy-success of a     cognitive behavioral self help intervention for insomnia. In this study all participants     receive an online self-help CBT manual consisting of information (psycho-education) about     sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a     popular scientific website to fill out online questionnaires. Participants will be measured     4, 16, and 40 weeks after intervention with the same questionnaires.   "
157290|NCT01224899|"     The investigators sought to evaluate the feasibility and safety of surgical sympathetic     blockade in systolic heart failure patients and secondary to assess its cardiovascular     consequences.   "
157344|NCT01224197|"     The purpose of this study is to assess the pharmacokinetics, safety and tolerability of     single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics (PK)     means how the drug is absorbed into the bloodstream, distributed in the body and eliminated     from the body.   "
157291|NCT01224886|"     Insulin resistance is a crucial factor for the development of type 2 diabetes and a major     health problem for older adults. It is the principal mechanism by which obesity is considered     to increase the risk for type 2 diabetes and is a key feature of the metabolic syndrome. The     elevated prevalence of obesity and type 2 diabetes in the older population has important     consequences on the morbidity and mortality as well as on the economic burden on society.     Controversy currently exists as to whether or not aging contributes to insulin resistance.     Many potential factors confound the association between aging and insulin resistance,     including obesity and physical inactivity.      Ectopic lipid depositions, defined as an excess accumulation of triglycerides in non adipose     tissues such as in the liver (intrahepatic lipids) and within the muscle fibers     (intramyocellular lipids), are positively associated with obesity and insulin resistance.     Furthermore, the accumulation of intracellular lipids is often cited as being a key     determinant in the underlying mechanisms of insulin resistance. In addition of playing an     important role in obesity and type 2 diabetes, these ectopic fat depositions are also     observed in common conditions such as aging and physical inactivity.      The intervention trial will test in skeletal muscle, liver and heart of sedentary obese     volunteers, normal weight volunteers and masters athletes, the overall hypotheses that     exercise improvement of fat oxidation capacity and/or decrease of damaging fat metabolites is     a primary factor that predicts the improvement in insulin resistance.   "
157292|NCT01224873|"     Breast cancer can metastasize to the bones, which leads to another treatment if bone     metastases are detected. The purpose of the study is to determine, if fluoride PET/CT is     superior to bone scintigraphy with technetium. On the other side, the investigators would     like to see if FDG-PET/CT is a reliable alternative to dedicated bone imaging to detect bone     metastases in patients with breast cancer.   "
157293|NCT01224860|"     In renal transplant recipients, residual renal insufficiency combined to the effects of     immunosuppressive therapy with steroids or calcineurin inhibitors may reduce insulin activity     and may contribute to several of the abnormalities associated with the metabolic syndrome,     such as hypertension, glucose intolerance and hyperlipidemia. In turn, insulin resistance,     hypertension, hyperglycemia and dyslipidemia may importantly contribute to the excess     cardiovascular risk of renal transplant patients (an excess comparable to that of diabetes     subjects with over diabetic nephropathy)and may also accelerate progressive renal function     deterioration and promote graft loss. Thus, amelioration of the insulin activity and of the     related metabolic syndrome is a key component of treatments aimed to improve patient and     graft survival in renal transplant recipients. Recently, drugs such as peroxisome     proliferators-activated receptor-gamma activators, that ameliorate insulin sensitivity and     metabolic syndrome, have become available.These agents, however, can provoke fluid retention,     weight gain, edema and, in some cases, heart failure.      Recent studies showed that telmisartan, an angiotensin II type 1 receptor antagonist, in     addition to block the angiotensin II type 1 - a key surface receptor involved in the     regulation of blood pressure - may also activate peroxisome proliferators-activated     receptor-gamma activators, thus improving some of the features of the metabolic syndrome.     Thus telmisartan may substantially reduce the overall cardiovascular and renal risk of renal     transplant recipients by ameliorating some of the modifiable components of the metabolic     syndrome. On the other hand, telmisartan is devoid of the adverse effects of peroxisome     proliferators-activated receptor-gamma activators such as fluid retention, and has therefore     a remarkably better risk/benefit profile. Thus, whether telmisartan in addition to the     beneficial effects of a reference angiotensin II type 1 receptor antagonist (such as     losartan) may offer adjunctive advantages related to improved insulin sensitivity in renal     transplant patients on chronic therapy with steroids and/or calcineurin inhibitors, is worth     investigating.   "
157294|NCT01224847|"     Patients with neovascular age-related macular degeneration (AMD) scheduled to receive     intravitreal (IVT) Ranibizumab injection will be randomized to receive one of three topical     anesthetics: (1) tetracaine drop (gtt) + lidocaine pledget to the injection site for 10     seconds (2) tetracaine gtt alone and (3) cocaine gtt alone. A questionnaire will be conducted     immediately after and 15 minutes after the injection, to assess for pain.   "
157295|NCT01224834|"     The purpose of this study is to determine the safety and tolerability of several doses of     ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic     rhinitis to ragweed.   "
157296|NCT01224821|"     Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry,     dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients     with low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The primary objective     of this study is to demonstrate that each site could accurately conduct the whole body     dosimetry required for the safe and effective dosing of Iodine-131 Anti-B1 Antibody.     Additional objectives of this study are to evaluate the efficacy, dosimetry, and safety of     Iodine-131 Anti-B1 Antibody.   "
157297|NCT01224808|"     The aim of the Von Willebrand Disease (VWD) therapy is to treat and prevent bleeding episodes     due to abnormal platelet adhesion and abnormal blood coagulation as a result of low or     abnormal Von Willebrand Factor (VWF) and/or Factor VIII (FVIII) levels. The long-term     efficacy and safety of a VWF/FVIII concentrate, Biostate, will be investigated in children,     adolescents, and adults with VWD in whom treatment with a VWF product is required for     prophylactic therapy, haemostatic control during surgery, or control of a non-surgical,     spontaneous, or traumatic bleeding event.   "
157298|NCT01224795|"     This is a study to evaluate the efficacy and safety of a single dose of intravenous peramivir     versus placebo in adolescents and adults with acute uncomplicated influenza.   "
157299|NCT01224782|"     The aims of this post-marketing observational study (PMOS) are to evaluate the time period     needed to achieve > 30% decrease of intact parathyroid hormone (iPTH) compared to the initial     values and to provide data on the tolerability and compliance of treatment with Zemplar     (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (SHPT) in patients     with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical practice.   "
157300|NCT01224769|"     This retrospective study collects and evaluates the clinical experience reached in Italy on     the use of bendamustine alone or combined with rituximab as treatment of patients with     relapsed or refractory chronic lymphoproliferative disorders.   "
157301|NCT01224756|"     The purpose of this study is to confirm the efficacy of tinoridine hydrochloride (HCL), three     times daily (TID), in the treatment of pain and inflammation in patients with acute     tonsillitis and/or acute pharyngitis of nonbacterial origin versus placebo.   "
157302|NCT01224743|"     Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient     supplementation that may offer cardioprotective effects. This study assessed the effects of     encapsulated fruit and vegetable juice powder concentrates on endothelial function and     cardiac risk markers in subjects in a randomized, double blind, placebo controlled crossover     clinical trial with three treatment arms.   "
157345|NCT01224184|"     The purpose of this study is to test the efficacy of a cultural-, age- and gender-focused     Human Immunodeficiency Virus (HIV) prevention intervention in reducing risk behaviors among     African-American young women relative to general health intervention.   "
157305|NCT01224704|"     Background:      - One area in which obese and lean individuals may be different is how their bodies handle     water balance and thirst. Studies done in animals suggest that individuals with greater body     fat may tolerate periods without water better than lean animals. Other research has found a     link between the ability to tolerate periods without water and increased body weight.     Researchers are interested in studying whether the ability to tolerate periods without water     and ability to feel thirst might differ in lean versus obese individuals.      Objectives:      - To evaluate the effects of water deprivation and feelings of thirst in lean and obese     individuals.      Eligibility:      - Healthy individuals at least 18 years of age who are either lean (body mass index less than     26 kg/m(2)) or obese (body mass index at least 35 kg/m(2)).      Design:        -  Participants will be screened with a medical history, physical examination, and blood          and urine tests.        -  Participants will spend the entire study (13 days) as inpatients at the National          Institutes of Health Clinical Center.        -  Participants will have the following tests and procedures:        -  Body composition assessment (using low-level x-rays) to determine the percentage of fat          tissue in the body.        -  Oral glucose tolerance test (similar to that often used to diagnose diabetes).          Individuals who are suspected to have diabetes will not be allowed to continue with the          study.        -  High salt infusion test, in which an infusion of saline (salt water) will be given for 2          hours and participants will respond to questions about how hungry and thirsty they feel          during the procedure.        -  Water deprivation test, in which participants will go for 24 hours without water or food          and respond to questions about how hungry and thirsty they feel.        -  24-hour stay in a metabolic chamber to determine how many calories participants burn in          a day.        -  A series of questionnaires about participants' eating habits, feelings about food, and          personal feelings, as well as computer-based tests involving the performance of various          tasks.        -  Measurement of free-living energy using doubly-labeled water, in which participants will          drink a sample of water with extra-heavy atoms of hydrogen and oxygen to evaluate the          amount of water in the body.        -  24-hour urine collection.        -  Frequent blood samples, urine collection, and fat tissue biopsies during the various          study procedures.        -  After the end of the 13-day study, participants will return after 1 week for a final          urine collection.   "
157306|NCT01224691|"     Background:        -  Human respiratory syncytial virus (RSV) is a virus that causes respiratory tract          infections, and is frequently responsible for hospital visits in infants and children.          It can also trigger severe breathing problems for individuals who have asthma, but these          infections are generally better tolerated in non-asthmatics. Some research suggests that          lack of an efficient immune system response in people with asthma may make it difficult          for the body to fight the effects of RSV.        -  Transforming Growth Factor-beta (TGF-[beta]) is a chemical in the body that is more          prevalent in the lungs of people with asthma and related respiratory disorders. More          information is needed about the effects of TGF-[beta] and whether it makes individuals          with asthma more prone to developing RSV. Researchers hope to use this information to          determine possible treatments and therapies for individuals with asthma who contract          RSV.      Objectives:      - To determine the possible role of TGF-[beta] in increased asthmatic susceptibility to RSV     infection.      Eligibility:      - Individuals between 18 and 60 years of age who are either healthy nonsmokers or mild     asthmatics.      Design:        -  This study involves a screening visit and a study visit.        -  Participants will be screened with a medical history and physical examination, as well          as blood samples and a pulmonary function test.        -  At the study visit, participants will receive mild anesthetic and have a bronchoscopy,          in which researchers insert a bronchoscope through the participant s nose or mouth and          into the lungs to examine the lungs and collect lung cells.        -  Participants will be contacted by a research team member 24 36 hours after the          bronchoscopy to ask about any side effects from the procedure.   "
157307|NCT01224678|"     RATIONALE: Vitamin D may help prevent breast cancer.      PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers in     female patients.   "
157308|NCT01224665|"     RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in     patients with invasive bladder cancer. It is not yet known whether extended pelvic     lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.      PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy to see     how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing     surgery for invasive bladder cancer.   "
157309|NCT01224652|"     The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy     with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients     with recurrent and metastatic gastric cancer who progress following first line therapy.   "
157310|NCT01224639|"     The purpose of this study is to assess the safety of Takeda's Tetravalent Dengue Vaccine     Candidate (TDV) (previously DENVax) in healthy adults when given as either a subcutaneous     (SC) or intradermal (ID) injection at two dose levels (low and high). The vaccine will be     given as two doses 90 days apart. Safety assessments include injection site evaluation and     adverse events. The immune response generated after vaccination will be assessed up to 9     months after the first vaccination.   "
157311|NCT01224626|"     To collect the efficacy and safety information in subjects who have been treated with Zyvox     (linezolid) for vancomycin resistance Enterococcus faecium infection for their appropriate     use in daily practice.   "
157312|NCT01224613|"     The purpose of this study is to compare the immunogenicity and reactogenicity of     self-administered intradermal influenza vaccine (Intanza)to nurse-administered.   "
157313|NCT01224600|"     The purpose of this study is to determine the prevalence and risk factors, at the time of the     diagnosis of PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm.   "
157314|NCT01224587|"     The purpose of this study is to monitor the gastrointestinal transport of eroding gel matrix     placebo tablets in healthy male volunteers under fasting and fed conditions. The method which     is used is an imaging technique.   "
157315|NCT01224574|"     The primary aim of the study was to assess whether D-Dimer level at entry or an increase of     D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular     events in patients with atrial fibrillation.   "
157316|NCT01224561|"     For a given food intake, fat and energy metabolism in adipose tissue and muscle adapt to     nutrient intakes. This adaptation to nutrition may be impaired in susceptible individuals or     in obese patients by promoting weight gain, either in constitutional thinness (MC) by     blocking it. The MC is a little known entity. These patients wish to grow for her and others.     Can they? We have demonstrated abnormalities of hormones regulating appetite (ghrelin, PYY,     GLP1 and leptin) that may participate in thinness. Furthermore, this thinness is associated     with osteoporosis in 25% of true MC who is 25 years old.   "
157317|NCT01224548|"     The purpose of this study is to study the potential benefits of low fat vegan diet in a     randomized, controlled and multi-centered workplace setting, the investigators will enroll     participants from 10 worksites of Government Employee Insurance Company (GEICO). After     randomization, 5 will be the vegan sites and 5 will be the control sites for 10 month study.     The vegan sites will receive low fat vegan diet instructions and weekly group sessions     starting from year 1. no intervention is done to the control sites until the week 18 when the     identical program will be given. At various time points, health measurements will be give to     all participants.   "
157346|NCT01224171|"     This study in patients with moderately to severely active Crohn's disease is designed to     establish the efficacy and safety of vedolizumab for the induction of clinical response and     remission.   "
157347|NCT01222546|"     This is an open-label, multi-center, dose-escalation Phase I study to evaluate safety,     pharmacokinetics and activity of CH5132799 administered orally as a single agent in patients     with advanced solid tumors.   "
157318|NCT01224535|"     Introduction: Iron deficiency anaemia remains a significant public health challenge.     Localized food based approaches may offer a large opportunity to improve lives and address     the widespread micronutrient deficiencies such as iron in affected households. Viable     solutions where iron rich foods are not readily available may come through diversification     approaches using foods such as amaranth grain reported to contain high iron content and good     quality protein in conjunction with the use of in-home fortification.      Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on     improving diet quality, iron intake and status in children 12-59 months in a semiarid area in     Kenya.      Study population: The study population will comprise children aged 12-59 months in Migwani,     within the larger Mwingi district, Kenya. Mothers or principal caretakers will be interviewed     on behalf of the children. In total, 270 children will be enrolled in the study.      Study design:      The study has a randomized controlled trial design conducted over a period of 4 months/16     weeks.      Treatment/hypothesis: All participating children will be required to take the provided     porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments     groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30     maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder     (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant     difference in hemoglobin and iron status between the three groups.      Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after     intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be     assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive     protein (CRP) will be done at the participating laboratories.      Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this     study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are     the secondary outcome. Iron deficiency will be defined as SF concentration <12 µg/L and     tissue iron deficiency will be defined as serum transferrin receptor concentration of     >8.3mg/L. Infection will be assessed by raised CRP (>10mg/L) as an indicator of acute     inflammation and presence of malaria.   "
157319|NCT01224522|"     - Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL     TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION        -  Short Title: Visionaire Alignment        -  Methodology: Monocentric, Single Blinded, Randomized Controlled Trial        -  Study Duration: November 2010 to July 2014        -  Study Centres: Leicester General Hospital, United Kingdom (UK)   "
157320|NCT01224509|"     The purpose of this study is to determine the effect of mifepristone on the expression of     three cervical EP3 receptor isoforms (EP3-2, EP3-3 and EP3-6) in pregnant women ≤63 days     gestational age.   "
157321|NCT01224496|"     The purpose of this study is to study the efficacy of Traditional Chinese Medicine (TCM) on     anaemic and cytopenic haematological disorders including myelodysplastic syndrome (MDS),     aplastic anaemia (AA), myelofibrosis (MF) and thalassemia intermedia who do not have or did     not respond to available treatment options.   "
157322|NCT01224483|"     Paroxysmal nocturnal hemoglobinuria (PNH) is a hematopoietic stem cell disorder in which     unregulated activation of the complement system leads to significant ischemic morbidities     with shortened lifespan. Life-threatening thromboembolism (TE) is the most feared     complication of PNH, accounting for up to 45% of patient deaths. It is estimated that 40% of     PNH patients experience a clinically evident TE and 60% of patients without clinically     diagnosed TE demonstrate TE by high-sensitivity MRI, indicating the ongoing thrombotic risk     in most patients with PNH. Much of these data come from PNH patients from European descent.     To understand the impact of TE in patients with PNH from non-European regions, we performed     this study to evaluate the clinical characteristics of Korean patients with PNH.   "
157323|NCT01224470|"     Dexmedetomidine is a new selective and potent alpha-2 agonist. It has centrally acting     anesthetic properties. It has been known that intrathecal addition of alpha-2 adrenergic     agents result in prolongation of the duration of the sensory and motor blockade induced by     hyperbaric bupivacaine. But the effects of intravenous dexmedetomidine on the spinal block     was not evaluated. The aim of study is to assess the effect of intravenous dexmedetomidine on     the low-dose spinal anesthesia for the transurethral surgery.   "
157324|NCT01224457|"     The pharmacogenomic profiles of drug metabolizing enzymes play an important role in     pharmacokinetics (PK) of drugs. Phenobarbital (PB), worldwidely used for neonatal seizure, is     a drug that requires careful dose adjustments based on therapeutic drug monitoring. It was     reported that phenobarbital (PB) metabolism was affected by CYP2C9 and CYP2C19 polymorphisms     in adults. This study aims to evaluate the effects of the CYP2C9 and CYP2C19 genetic     polymorphisms on PB PK in infants with neonatal seizure for an optimal dosing strategy.   "
157325|NCT01224444|"     Colorectal cancer is the second most common cause of cancer death in the US. Colonoscopy is     considered the best test colorectal cancer screening. It allows resection of adenomatous     polyps (a known cancer precursor) and thus, interrupt the adenoma-carcinoma sequence. Despite     the potential benefit of screening colonoscopy recent studies have reported cases of     colorectal cancers in a short interval after prior screening or surveillance colonoscopies.     One possible cause of such interval cancers may be incomplete resection of adenomatous polyps     and hence ongoing growth and cancer development in such lesions. Complete resection may be     particularly important for polyps of at least 5mm in size as up 10% of such polyps higher     risk lesions as villous adenoma, tubulovillous adenoma, high grade dysplasia, or early     carcinoma.      Although adenoma resection of sessile and flat adenomatous polyps between 5 and 20mm is     believed to be well standardized data on complete resection of adenomatous tissue are sparse.     This may be related to the assumption that using a snare with electro-cautery will     successfully remove the polyp and cauterize remaining marginal adenomatous tissue and hence     completely remove and or destroy the lesion.      The investigators are interested in examining how often sessile adenomatous polyps between 5     and 20mm are completely removed using standard polypectomy snare. The investigation was also     directed at a comparison between complete resection of polyps between 5 and 9mm and 10 and     20mm.   "
157326|NCT01224431|"     Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered     lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing     pain prior to lumbar puncture in infants.      Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3     months of age, presenting to the emergency department meeting clinical criteria for a lumbar     puncture. All patients were administered the J-tip and randomized to either treatment with 1%     lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.   "
157329|NCT01224392|"     The investigators propose a randomized non-inferiority trial that compares preoperative     Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated     boost. In patients with T3-4 rectal cancer, the latter approach is considered preferential     with regard to toxicity and cost. The metabolic response of the tumor, as assessed by     18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be     used as a surrogate marker of cause specific outcome   "
157335|NCT01224314|"     In a study published in 1995 in the American Journal of Kidney Diseases, Dolson et al     demonstrated that a rapid decrease of serum potassium concentrations during haemodialysis     would produce a significant increase in systolic blood pressure at the end of the session,     even though there were no clear effects on intra-dialytic blood pressure. The authors defined     this post-dialysis blood pressure behaviour as rebound hypertension. Paradoxically, in     animal models, other than in the context of end-stage renal disease, potassium is a     vasodilator. Considering that the removal of potassium during the haemodialysis session could     be theoretically modulated in profiles (as with sodium and bicarbonate), it was deemed     suitable to delve deeper into this argument by studying, in detail, the (non invasive)     hemodynamic repercussions of changes in the potassium concentration of the dialysate. Not     being able to linearly modify the concentration, we decided to divide the dialysis session in     3 tertiles, randomising the patients to all possible dialysate sequences containing the usual     concentration of potassium or two cut-off points at +1 and -1 mmol/l. Haemodynamic     measurements were performed using a finger beat-to-beat monitor.   "
157336|NCT01224301|"     Purpose of the study. The purpose of the project is to evaluate the feasibility,     acceptability, and cost effectiveness of providing influenza vaccine in schools to children     in grades Kindergarten through 6th grade.      Hypothesis 1: School based influenza vaccination (SIV) will increase the overall rate of     influenza vaccination in school children.      Hypothesis 2: Higher intensity parent notification about school based influenza vaccination     does not increase immunization rates compared to low intensity.      Hypothesis 3: School based vaccination from the perspective of mass vaccinators is cost     neutral.   "
157337|NCT01224288|"     This is a companion protocol to MD Anderson Cancer Center study 2010-0085 (Sequential Therapy     in Advanced Renal Cell Carcinoma Therapy: The START Trial).      The goal of this clinical research study is to learn if dynamic contrast enhanced computed     tomography (DCE-CT) scans can help researchers learn if the study drug received as part of     study 2010-0085 (either everolimus, bevacizumab, or pazopanib) is working.   "
157338|NCT01224275|"     The Study compares group based care versus individual given care-effects on patient     satisfaction and health. Midwives will be randomized to either traditional antenatal care     (Individual care) or group based antenatal care(intervention).   "
157339|NCT01224262|"     This study is designed to evaluate the safety, tolerability, and immune response of LIQ001     mixed with a commercially available seasonal influenza vaccine (Fluzone) in two populations     of subjects; healthy adult subjects 18 to 49 years of age and healthy elderly subjects 65     years of age or older.   "
157340|NCT01224249|"     The primary aim of this study is to investigate, whether higher intake of selenium rich food     items such as fish and shellfish, is associated with higher selenium blood levels.      The secondary aim is to investigate the uptake of selenium from fish and shellfish and the     incorporation of selenium from those foods into proteins in the human body. Furthermore, the     impact of the natural variation in the genes that are responsible for the accumulation of     selenium in the proteins will be investigated.   "
157341|NCT01224236|"     The purpose of this study is to determine if iron supplementation in addition to routine iron     intake decreases the risk of developing anemia in preterm infants.   "
157342|NCT01224223|"     Myeloid-derived suppressor cells (MDSC) have been studied for their ability to suppress T     cell responses in vivo and in vitro. As a result, MDSC can regulate cellular responses to     chronic inflammatory conditions such as cancer, leading to the induction of tolerance and,     ultimately, tumor escape from immune surveillance.   "
157353|NCT01222468|"     This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on     spasticity in spinal cord injured persons.The study will be a phase 2, randomized,     placebo-controlled crossover study. Each eligible subject will participate for 26     weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the     study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the     first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the     opposite arm for another 11 week treatment period (phase 2).   "
157354|NCT01222455|"     A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic     (liver) function compared with healthy volunteers with normal liver function. The study will     also evaluate safety and tolerability in subjects with hepatic impairment.   "
157355|NCT01222442|"     The purpose of this research study is to evaluate the effect of AZD3199 on the electrical     activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic     (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known.     Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will     also be assessed.   "
157343|NCT01224210|"     This is an Open Label, Multicenter, pilot clinical trial to assess the efficacy and safety of     an oral selective Endothelin Receptor Antagonist (ambrisentan) in patients with     portopulmonary hypertension.      Preliminary evidence suggests that ambrisentan is safe and effective in patients with     portopulmonary hypertension. The goal of therapy for these patients is to improve symptoms of     dyspnea and to improve pulmonary hemodynamics to a mean pulmonary artery pressure <35 mm Hg     in order to make patients eligible for liver transplantation. Therefore, the primary     endpoints for this study will include 6 minute walk distance (6MWD) and pulmonary vascular     resistance (PVR).      Eligible subjects will receive 5 mg ambrisentan once-daily for the first 4 weeks. After the     initial 4-week period, investigators will increase study drug dose to 10 mg once daily (both     5 mg and 10 mg doses are FDA approved). If 10 mg is not tolerated in the opinion of     investigator, then the investigator may decrease the dose back to 5 mg once daily. Primary     outcome is a change in both the 6MWD and in PVR from baseline to Week 24. Subjects will be     monitored with liver function tests (LFT) every 2 weeks for the first 8 weeks, then every 4     weeks thereafter. These safety laboratory tests may be performed at a local phlebotomy     laboratory or at the Investigator clinic. In addition, the Investigator will assess each     subject for safety and efficacy at Week 4, Week 12, and Week 24. Following Week 24, subjects     will be assessed for safety and efficacy every 12 weeks. Patients will be followed for a     total of 1 year. After 1 year, if the Investigator feels that continuing the treatment will     be beneficial to the patients, they will be provided with ambrisentan by Gilead     Pharmaceuticals, free of charge.   "
157348|NCT01222533|"     The purpose of this study is compare the effect of different doses of tiotropium delivered by     the HandiHaler and Respimat device on lung function. Additionally, the study will investigate     the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile     shows what happens to the medication in the body over a period of hours and provides     information on potential effects of the medication.   "
157349|NCT01222520|"     If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an     antihypertensive drug from different class should be started concomitantly.      In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential     hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg,     the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg     monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan     80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her     blood pressure controlled with telmisartan 80 mg.      Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and     safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different     pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with     telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who     fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg     monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy,     active-controlled, parallel group comparison method is employed.   "
157350|NCT01222507|"     The overall purpose of this research is to assess whether both the 60 second Brain Game and     the Brain Speed Test computer-based programs can be used as assessment tools for     objectively defining the severity of the functional impact of tinnitus.   "
157351|NCT01222494|"     The US prevalence of childhood-onset obesity and type 2 diabetes, both predictors of     cardiovascular risk, have increased to epidemic proportions in recent decades. Children with     mental illness, especially those treated with antipsychotic medications, are at additional     risk for obesity (adiposity) and related risk conditions. A variety of noninvasive techniques     to assess cardiometabolic risk have begun to be applied in children, including body     composition measured with dual energy x-ray absorptiometry (DEXA), carotid intima media     thickness (CIMT) measured by ultrasound, and hepatic triglyceride content (HTGC) measured by     1H Magnetic Resonance Spectroscopy (MRS). These measures allow for the early, noninvasive     study of adiposity-related metabolic risk. The overall aim of this two-study research plan is     to characterize the level of measurable risk using these sensitive markers in treated and     untreated children with mental health disorders, and to evaluate the magnitude of change in     risk that can be observed using these biomarkers in children receiving a well established     behavioral weight-loss intervention.   "
157352|NCT01222481|"     Cancer survivorship has dramatically improved within the last four decades and a greater     number of Americans are living after cancer diagnosis. An increase in the number of survivors     has highlighted the need to investigate the quality of life experienced by these survivors.     While Survivorship research has improved our understanding of the challenges faced by some     cancer survivors, there is a paucity of research on the functional and cognitive health     status of head and neck cancer survivors.      The purpose of this study is to evaluate the functional and cognitive changes that occur in     head and neck cancer patients as a result of cancer treatment, in an attempt to increase our     understanding of the complex interactions between cancer treatment, comorbid health ailments     and quality of life.   "
157356|NCT01222429|"     This study aims to test a dietary intervention for diabetes in a medical practice setting,     with the aim of developing a model for diabetes care that can be used widely. The     investigators hypothesize that a low-fat vegan diet will be effective for management of     diabetes and will be feasible in a practice-based setting.   "
157359|NCT01224132|"     This study was designed to evaluate the efficacy of probiotics in the treatment of atopic     dermatitis. Probiotics in AD patients were effective in reducing SCORAD index levels, but not     effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum     total and specific IgE levels.   "
157360|NCT01224119|"     The current research study evaluates an investigational medical device called Amplex B2A(TM)     Peptide Enhanced Ceramic Granules (Amplex) for use in foot and ankle fusion. Amplex is a     synthetic bone graft material. The most frequently used graft material is bone collected from     the patient (autograft). Autograft involves a secondary incision with the risks of infection     and lasting pain.      The purpose of this study is to determine if Amplex is a safe and effective alternative to     autograft.   "
157361|NCT01224106|"     This multi-center, randomized, double-blind, placebo-controlled parallel-group study will     evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety     and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be     randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo.     Participants who consent to be part of the sub study will undergo positron emission     tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is     104 weeks, with an option for an additional 2 years of treatment.   "
157362|NCT01224093|"     This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab)     in combination with chemotherapy in patients with previously untreated or relapsed/refractory     B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for     6-12 months, depending on the prescribed chemotherapy regimen.   "
157363|NCT01224080|"     A condition called hydrosalpinx occurs when one or both of the fallopian tubes is blocked     with fluid. The fluid can leak into the tube and the uterus. The theory is that the fluid can     harm the tubes and uterus making implantation more difficult or harm the embryo.   "
157364|NCT01224067|"     This is a 16-week research study in which participants suffering from Social Anxiety Disorder     (SAD) will receive Sertraline (a medication FDA approved for the treatment of SAD) for the     first 8 weeks. If a participant remains symptomatic, he/she will enter the second phase of     the study in which he/she continues taking Sertraline but also randomly receives either     Seroquel or placebo in conjunction with Sertraline for additional 8 weeks. The purpose of     this study is to determine the efficacy of adjunctive Seroquel in treating SAD.   "
157576|NCT01221116|"     Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics     after cardiac surgery and lead to reduced stay at intensive care unit   "
157365|NCT01224054|"     The worldwide epidemic of overweight and obesity affects about 1.7 billion people around the     world. Since 1991, many international medical societies have established as recommendation     for bariatric surgery the unsuccessful clinical treatment in patients with IMC > 40Kg/m2 or     IMC > 35Kg/m2 in the cases with serious co-morbidities related to the possible reversion of     them with the lose of weight due to the surgery. In front of the new anatomical condition     from the gastrointestinal tract the patients present changes in food preferences and in the     food intake, which include modifications in food choices, perception of hungry and satiety     and in the tolerance to determinate food. These changes in food intake of the patients are     observed mostly in the first year after the surgery an adaptive phase to a new condition.   "
157366|NCT01224041|"     This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid     Arthritis patients who showed unsuccessful response against methotrexate.   "
157367|NCT01224028|"     This study is to evaluate efficacy and safety of tacrolimus in the patients with     non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with     tacrolimus (Prograf) or placebo.   "
157368|NCT01224015|"     This study will evaluate the safety and efficacy of botulinum toxin type A compared to     placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients     who successfully completed Study 191622-099.   "
157369|NCT01224002|"     The prevalence and severity of dental caries in incarcerated people who abuse drugs are     unknown but an inmate reporting to the dental clinic typically presents with myriad findings:     oral signs of uncontrolled decay on the buccal smooth surfaces of the posterior teeth and     interproximal surfaces of the anterior teeth, excessive tooth wear due to grinding and     clenching, and gingival inflammation. The primary risk factors for the development of caries     appear to be the combination of xerostomia, frequent consumption of carbonated soft drinks,     high dental plaque levels and nonexistent or inadequate oral hygiene. Since some of these     findings are seen in the other disease states, specifically in substance abuse cases, the     diagnosis is often not clear. The objective of the project is to design a cross sectional     comparative feasibility study that will estimate the prevalence, pattern, and severity of     untreated dental decay for three types of inmates: methamphetamine abusers, substance abusers     not identified as methamphetamine users, and non-substance abusers, focusing in on     methamphetamine abusers as the highest risk group.      Recruitment will be accomplished using a 2-phased process. Phase I. An invitation letter     explaining the study purpose and its relevance to oral health in a correctional setting will     be mailed to the inmate population at two Federal Bureau of Prisons' institutions who entered     the prison system during the first half of 2009. Dublin, a female FCI located in Northern     California and Butner, a male FCC located in North Carolina were the selected facilities due     to the high incidence of drug abusers among their inmates. The letter, which will invite all     inmates to participate in the study, will inform the inmate should they consent to     participate in the study that they will have their existing dental record confirmed, Central     File reviewed for DSM-IV diagnosis pertinent to the study, and that they will be given a     study questionnaire. Positive responses to the invitation letters will be returned to Dr.     Johnson at head quarters in Washington DC. The psychology division will code the volunteer     inmates into the three study groups.      Phase II. The first 30 chronologically documented volunteers in each study group category     will be scheduled an appointment. A consent form will be read and explained to each inmate,     in either English or Spanish as appropriate and his/her signature obtained as his/her     informed consent.      Each question on the study questionnaire will be read to the inmate volunteer and the     Research Associate will record the answer. A retrospective comparative study will then be     employed utilizing the inmate's initial dental intake exam (routinely administered by the     Federal Bureau of Prisons' dental department). The dental chart will be abstracted for dental     caries. The pattern of surface-specific dental caries (DFS index) will be described and     analyzed. The focus will be on the levels of untreated and treated disease diagnosed in a     4-zone partition of the oral dentition, representing a modification of the zones identified     in the Grainger's caries severity index scoring system as this partition allows focus on     decay patterns of anterior tooth surfaces. The multivariate summary of disease levels within     each zone will be derived and statistically compared across the three study groups using     Hotelling's t2-test (the multivariate extension of the Student-t test). The results of the     study will be used to do a preliminary assessment between methamphetamine drug abuse and oral     health and determine whether a prospective clinical study is warranted.   "
157370|NCT01223989|"     The purpose of this study is to determine the utility of an hypocaloric diet with or without     bread in patients with overweight and obesity   "
157371|NCT01223976|"     The purpose of this study is to determine the level of agreement between QuantiFeron -TB Gold     test (QFT-G)and Tubeculin skin test (TST)for screening of latent tuberculosis in patients     suffering from psoriasis.   "
157372|NCT01223963|"     This is a retrospective, multicenter chart review of medical records on the use of Macrolane     for female breast enhancement.      The primary objective is to evaluate the safety profile of Macrolane Volume Restoration     Factor 20 and Macrolane Volume Restoration Factor 30 when used for female breast enhancement     in clinical practice.   "
157373|NCT01223950|"     To research the prevalence and nature of DRP (Drug Related Problems) associated     hospitalizations (hospitalizations due to problems\adverse effects of the medication     treatment) .      Analyzing the main reasons for DRP associated E.R admissions\hospitalizations. identifying     drug involved and percentage of DRP associated hospitalizations.      Monitoring the length of DRP associated hospitalizations. Evaluating LOS to hospitalized.     Financial and other aspects will be measured.   "
157374|NCT01223937|"     A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to     investigate the safety and efficacy of desmopressin oral melt tablets against placebo during     3 months of treatment in adult females with nocturia.   "
157375|NCT01223924|"     This is a randomized double-blinded placebo-controlled，single-dose escalation trial in     healthy volunteer.   "
157376|NCT01223911|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the     body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).   "
157377|NCT01223898|"     This study will evaluate the effects of multiple doses of nilotinib on the pharmacokinetics     and metabolism of midazolam (as a sensitive CYP3A probe) in CML patients. The following     extension study does evaluate the safety of nilotinib.   "
157378|NCT01223885|"     By performing a challenge with camel's milk in patients who are allergic to cow's milk, the     investigators will examine if camel's milk is a safe alternative for these patients.   "
157379|NCT01223872|"     This two-part research study will compare childhood cancer survivors receiving specialized     follow-up care in the REACH for Survivorship clinic to patients receiving routine follow-up     care.   "
157380|NCT01223859|"     Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in     the treatment of habitual snoring. The decision making process in the management of habitual     snoring would benefit from diagnostic guidelines for oropharyngeal findings. The aim was to     investigate the correlation of systematic clinical pretreatment oropharyngeal examination     scores with the efficacy of interstitial RF surgery of SP in a multi-center study   "
157381|NCT01223833|"     The Logribmet study is a prospective study that evaluate grip strength changes in both hands     of postmenopausal women with breast cancer receiving treatment with tamoxifen or an aromatase     inhibitor. Patients included in the study will undergo a grip strength measurement and     receive a rheumatological questionnaire prior to the start of treatment, then at 3 and 6     months and at year 1 into therapy. Furthermore, BMI will be measured to assess if BMI is a     predictor for the decrease in grip strength.      IGF-I, GH and IGFBP-3 serum levels will also be measured at all time points.   "
157382|NCT01223820|"     The term idiopathic rhinitis (IR) is used in this study to describe a patient group with     following characteristics: patients with complaints of nasal obstruction, sneezing and/or     rhinorrhea for a period of over 1 year, which cannot be attributed to allergy, nasal or     paranasal infection, anatomical disorders, pregnancy or lactation and/or systemic disorders.     These patients are non-smokers and do not use medication affecting nasal function. They have     no beneficial effect of intranasal steroid spray (INS) treatment.      The population incidence of IR is estimated to be as high as 10%. The pathophysiology of IR     is largely unknown. Several hypotheses have been put forward. In general it is assumed that     neurogenic mechanisms play an important role. Neuropeptides like CGRP, SP, NKA/B, NPY, NGF     are released from afferent neurons in the nasal mucosa after activation by unspecific stimuli     and can be responsible for the symptoms of IR.      For this group of IR-patients, there is until now only one treatment option: intranasal     capsaicin application. Capsaicin, the pungent agent in hot pepper, is supposed to exert its'     therapeutic effect via degeneration or desensitization effect on the afferent C-fibers.      The hypothesis is that nasal capsaicin treatment reduces neurogenic inflammation and reduces     in that way nasal symptoms.   "
157404|NCT01222364|"     This study tested the feasibility of conducting a randomized controlled trial to vary the     timing that doctors clamp the umbilical cord after birth in extremely low birthweight     infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding     the newborn approximately 10 inches below the birth canal would result in increased     hematocrit at 4 hours of age.   "
157383|NCT01223807|"     Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients     with chronic obstructive pulmonary disease (COPD). Several studies have described an     impairment in diaphragmatic mobility of COPD patients compared to age matched control     subjects and it has been associated with increase in dyspnea, exercise intolerance and     mortality. COPD patients also experiment a higher activity of the accessory breathing     muscles, which greatly increases the work of breathing and dyspnea sensation.      Breathing strategies have been considered an important component of pulmonary rehabilitation     and refer to a range of techniques, including/which includes the diaphragmatic breathing     (DB). The principal aim of DB is to improve the participation of the abdominal motion while     reducing the accessory muscles activity. The role of DB as an adjunctive treatment modality     in the rehabilitation of COPD patients remains controversial. Despite the conflicting     results, improvement of the abdominal motion and a reduction of thoracic excursion, during     voluntarily DB, has been described as a common finding of several studies. The investigators     hypothesized that a 4-week DBTP could induce higher participation of the diaphragm and this     modification would relieve respiratory symptoms and improve exercise tolerance and the HRQoL.     Therefore, in this randomized controlled trial the investigators aimed to test the effects of     a short-term DBTP on thoracoabdominal motion, pulmonary function, diaphragmatic mobility,     dyspnea, HRQoL and exercise tolerance in patients with mild to severe COPD.   "
157384|NCT01223794|"     Goals and future prospects:        1. To finish the survey of the high risk factor ratios and high incidence rates associated          with falls among inpatient fallers.        2. To investigate the risk factors associated with falls and the consequential analysis          related to falls among inpatient fallers.        3. A good precautionary measure of falls will reduce damages and injuries for the fallers,          especially inpatients welfare. Our accomplishments of this research proposal will          provide sufficient information and reference for the precautionary strategies associated          with fall incidents. More importantly, the experiences and results will be further          explored and shared among all other hospitals.   "
157385|NCT01223781|"     Objective/Rationale:      The investigators objective is to demonstrate that an intervention program based on motor     learning principles can be applied to train subjects with Parkinson's disease (PD) who suffer     from freezing to walk in a way that minimizes the occurrence of freezing. Since sufficient     motor learning capabilities are preserved in PD, the investigators hypothesize that an     intervention program that targets the time periods just prior to an approaching freezing     episode can modify the walking strategies so that the episode will now be averted.      Project Description:      The freezing burden will be quantified in subjects with PD before and after 6 weeks of     training. Two types of interventions (20 subjects in each group) will be tested: 1) Open-loop     group (OLG); 2) Closed-loop group (CLG). Each session of the OLG training includes walking     courses aimed at provoking freezing episodes. The experimenter will trigger an auditory     rhythmic stimulation (RAS) in walking conditions likely to invoke freezing (e.g., turning)     and the subject will learn to synchronize his/her gait with the auditory cues, i.e., to keep     the walking pace and coordination and, as a result, to avoid freezing. Similar principles     will apply for the CLG training; however, the RAS will be elicited automatically by a device     that recognizes an approaching freezing episode.      Relevance to Diagnosis/Treatment of Parkinson's Disease:      If even partially successful, the investigators will show, for the first time that freezing     of gait is amenable to motor learning and that appropriate training with external cueing can     alleviate these motor blockades. While future studies will be needed to further assess     long-term efficacy and other important questions about clinical efficacy and the mechanisms     involved, this study should go a long way towards improving the investigators understanding     of freezing of gait and its amenability to appropriate therapy.      Anticipated Outcome:      The investigators anticipate that after intensive training, the central nervous system (CNS)     of subjects with PD will be able to anticipate impending freezing episodes based on awareness     of the environmental conditions (e.g., an approaching turn) and/or based on sub-conscious     response to a deteriorating gait pattern. As a result, an automated motor response that paces     and coordinates gait will be internally triggered by the CNS and the approaching freezing     episode will be averted. The overall freezing burden will therefore decrease in trained     subjects.   "
157386|NCT01223768|"     To assess the clinical efficacy of ALC in the treatment of severe hepatic encephalopathy     (grade 3 of the West Haven grading scale), we performed a randomised, double blind     placebo-controlled study administering ALC to cirrhotic patients, evaluating the effects on     ammonia levels and performance in cognitive functions.   "
157387|NCT01223755|"     The general aim of this study in adult patients with Autosomal Dominant Polycystic Kidney     Disease (ADPKD) and severe renal insufficiency is to assess the safety and the efficacy of     sirolimus (SRL) in slowing renal function decline as compared to conventional therapy.   "
157388|NCT01223742|"     The aim of this study was to evaluate the effect of exogenous ALC on the both physical and     mental fatigue in mild and moderate encephalopatic patients.   "
157389|NCT01223729|"     Minimal hepatic encephalopathy represents a common complication present in well-compensated     cirrhotic patients that impairs patients daily functioning and health-related quality of     life. Acetyl-L-carnitine has been shown to be useful in improving blood ammonia and cognitive     functions in cirrhotic patients with minimal hepatic encephalopathy. This study evaluated the     effects of acetyl-L-carnitine treatment on health related quality of life and on depression     in patients with minimal hepatic encephalopathy.   "
157390|NCT01223716|"     Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of     vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This     study uses psychophysical measures to study neural plasticity in adults with amblyopia.   "
157391|NCT01223703|"     The purpose of this study is to test the hypothesis that n-3 PUFAs improve left ventricular     systolic function in patients with stable chronic HF secondary to nonischemic dilated     cardiomyopathy (NICM).   "
157392|NCT01223690|"     The herein protocol is based on the results of one former clinical trial conducted by our     study group showing the considerable efficacy of intravenously administered clarithromycin as     an adjuvant to antimicrobial chemotherapy for patients with sepsis, septic shock and     respiratory failure in the field of ventilator-associated pneumonia. The proposed clinical     trial is based on the need to generalize the application of intravenous clarithromycin in the     total of admitted septic patients irrespective of the underlying cause of sepsis.   "
157467|NCT01222858|"     The proposed project addresses the significant problem of obesity and uses innovative     technology to improve adherence to a behavioral weight loss strategies. If the program is     effective, it would provide an outstanding resource for physicians to use with their patients     and thus would have tremendous clinical impact.   "
157468|NCT01222845|"     The purpose of this study is to assess the postprandial glycaemic, insulinaemic and appetite     responses to porridge made with oats processed differently.   "
157469|NCT01222832|"     This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a     sponge soaked in Saline / and the administration of oral antibiotics.   "
157393|NCT01223677|"     Depression and anxiety disorders are highly prevalent and associated with reduced quality of     life for patients and enormous economic costs for society. Although effective treatments are     available, a substantial number of patients fail to respond, and the time between disorder     onset and treatment is typically long. The development of prevention programs therefore     appears promising. The current project aims to prevent depression and anxiety by targeting     excessive levels of worry and rumination, two important risk factors for emotional disorders.     Participants will be selected on the basis of a high score on two validated questionnaires on     worry and rumination. They will be randomly assigned to a rumination-focused     cognitive-behavioral training delivered in a group format, a rumination-focused     cognitive-behavioral training delivered via internet, or a no-training control condition. It     is expected that both versions of the rumination-focused training will reduce symptoms of     depression and anxiety, will reduce the incidence of major depressive episodes and     generalized anxiety disorder, and will reduce symptom levels of other emotional disorders.   "
157394|NCT01223664|"     The objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow     stem cells (BMSCs) transplantation in patients with liver cirrhosis. The evaluation of the     efficacy includes the level of serum alanine aminotransferase (ALT), aspartate     aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB),     prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver     histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores     and clinical symptoms were also observed simultaneously.   "
157395|NCT01223651|"     10 healthy volunteers will undergo the controlled lowering of their blood glucose level at     sea level and a simulated altitude of 8,000 feet, to test the hypothesis that continuous     glucose monitoring system measurement of blood glucose is as accurate at altitude as at sea     level.   "
157396|NCT01223638|"     Congenital hypothyroidism (CH) occurs in 1:4000 live births. Neurological disturbances like     speech delay, motor delay and lower IQ were reported in children with CH. Evidence from     animal experiments indicate that CH is associated with high frequency of deafness.     Morphological changes of the external and internal cholera hairs were reported in mutagenic     mice with CH. Anatomical changes of the internal ear and low hearing threshold were reported     in mice bearing Dual oxidase 2 (Duox2) gene mutations, which is responsible of oxidation of     iodide. Knockout of Pax8 gene in mice resulted in both agenesis of thyroid gland and     deafness. Early L-thyroxin therapy prevented the development of deafness in those mice. The     expression of thyroid receptor α (TRα) in the external and internal cholera hairs in mice     indicates that the thyroid hormones have an important role in the development of the internal     ear.      The etiology of deafness in human is both genetic and environmental. The prevalence of     deafness in live births is 1:1000 and among them 60% is genetic. Connexin 26 gene mutations     are the most common cause of inherited deafness and account for about 40% of the genetic     cases. In two conditions in human the coexistence of hypothyroidism and deafness were     reported; Pendred syndrome and thyroid hormone resistance syndrome.      The prevalence of hearing loss in human with CH was explored in only few studies and the     results are contrary.      The aim of the current study is to study the prevalence of hearing loss among children with     CH and to compare the clinical, biochemical and genetic characteristics between subjects with     hearing loss to those without hearing loss.   "
157397|NCT01223625|"     The aim of this study was to measure the effect of moderate and intensive lipid-lowering     treatment with rosuvastatin on the endothelial function.   "
157398|NCT01223612|"     This exploratory study will compare the effects of ranibizumab treatment with conventional     macular laser therapy for patients with diabetic macular oedema.      The study hypothesises that treatment with ranibizumab may be superior to laser treatment in     terms of improving vision and decreasing retinal thickness.      Patients will be randomised to receive either repeated injections of ranibizumab every 4     weeks for 48 weeks or macular laser therapy every 12 weeks for 48 weeks.      At baseline, and then at 12, 24 and 48 weeks, patients will undergo detailed testing to     provide information on the structure and function of the retina with both of these     treatments.   "
157399|NCT01223599|"     To evaluate and compare between excision with primary closure of wound and excision with     Rhomboid flap reconstruction in the treatment of pilonidal sinus as regard duration of     operation, healing time, hospital stay, complications and recurrence rate.   "
157400|NCT01223586|"     The objective of this study is to verify the relationship between coronary plaque regression     and cardiovascular prevention in long term follow up of the Japan Assessment of Pitavastatin     and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS) study [NCT00242944]. In addition, the     effect of serum lipid levels or different type of statins on cardiovascular prevention will     also be examined.   "
157401|NCT01222403|"     This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women     aged 65 years and older.   "
157402|NCT01222390|"     The purpose of this study is to explore the volume change and location of volume change in     reconstructed breasts using the Contour Profile® tissue expander. Our purpose is also to     investigate the safety of using CPX3® in tissue-expander breast reconstruction via a     comparison between the complication rates that result from this study and the complication     rates with the use of other tissue expander types, as reported in the literature. We also     hope to demonstrate the use of 3-D imaging technology as an objective measure of upper and     lower breast volume change and location of this volume change in the reconstructed breast.     Finally, we intend to provide reconstructive surgeons with a scientific study that quantifies     the patient satisfaction with aesthetic results of CPX3 in tissue expander-implant breast     reconstruction. We hypothesize that the CPX3 tissue expander will provide more lower pole     volume expansion when compared to lower pole volume expansion from round, standard tissue     expanders as reported in the literature. Additionally, we hypothesize that CPX3, in     combination with human acellular dermis, is less prone to complications than standard tissue     expanders (again, as reported in the literature).   "
157403|NCT01222377|"     RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast     cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial     studies endoscopic breast surgery in treating patients with breast cancer.   "
157653|NCT01220115|"     A long term observational study in sickle cell disease will enhance the understanding of the     disease patterns, current transfusion practices, treatments and outcomes in sickle cell     disease.   "
157405|NCT01222351|"     The overall goal of this project is to establish and validate biomarkers associated with the     risk and progression of late onset Alzheimer's disease, mild cognitive impairment and     cognitive decline. The investigators will use baseline and longitudinal measurements of     plasma amyloid beta-40 and amyloid beta-42 to investigate the risk of developing mild     cognitive impairment and late onset Alzheimer's disease, as well as the rates of cognitive     decline and Alzheimer's disease progression. Participants will be selected on the basis of     change in plasma amyloid beta levels over prior assessment intervals. The purpose of the     study is to examine whether brain amyloid plaque load, which will be measured with positron     emission tomography and x-ray computed tomography brain imaging using Florbetaben from Bayer,     varies as a function of change in plasma levels of amyloid beta. The driving hypothesis of     the study is that high plasma levels of amyloid beta are an antecedent indicator of increased     risk of cognitive decline, mild cognitive impairment, and incident late onset Alzheimer's     disease, and that declining plasma levels of amyloid beta are associated with the onset of     cognitive decline. Further, high plasma levels of amyloid beta are related to increased     levels of amyloid beta in the brain as measured by positron emission tomography positivity,     and the specific pattern of positron emission tomography positivity and a decline in plasma     amyloid beta over time are associated with the onset of cognitive decline associated with     late onset Alzheimer's disease.   "
157406|NCT01222338|"     Treatment of multidrug-resistant TB (MDR-TB) is 100 times more expensive than treatment of     drug-susceptible TB, requiring intensive clinical management for prolonged time (18-24     months) and more toxic treatment course. In prior open label study the investigators have     shown that adding V-5 Immunitor (V5), can reduce treatment duration to one month and enhance     by 4-5 fold the efficacy of TB drugs. Furthermore, V5 has been shown to reverse or reduce     liver damage caused by chemotherapy. The cost of V5 will be very modest. The investigators     propose to conduct placebo-controlled clinical trial in patients with treatment refractory TB     so that the clinical benefit of V5 is confirmed.   "
157407|NCT01222325|"     In order to check if a reduction in the frequency and total number of shocks delivered during     extracorporeal shockwave lithotripsy (SWL) results in a great number of stone-free     patients,the investigators compared two different ways of treating urinary stones using SWL.   "
157408|NCT01222312|"     The study compares two combinations of chemotherapy in patients with advanced or metastatic     NSCLC: 50% of the patients are treated with cisplatin and docetaxel, the other 50% with     oxaliplatin and docetaxel. cisplatin is today the standard therapy, but the toxicity profile     is often not tolerable. Especially in elderly patients or patients with comorbidities,     oxaliplatin based chemotherapy may have lower toxicities but comparable or even better     response rates.   "
157409|NCT01222299|"     The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal     product in seasonal allergic rhinitis patients.   "
157410|NCT01222286|"     The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of     two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma.   "
157411|NCT01222273|"     The purpose of this study is to see if giving people with CF and ABPA enough vitamin D to     make their blood levels of the vitamin higher, will reduce the allergic response in their     body and make the symptoms caused by ABPA better.   "
157412|NCT01222260|"     The study is being done to see if the combination of bendamustine and dexamethasone will help     people with amyloidosis that has returned after standard treatment, and to to estimate the     partial hematologic response rate (PHR).   "
157413|NCT01222247|"     Infants born between 34 and 36 weeks of gestation, known as 'late preterm', are more likely     to be admitted to a special care nursery, and more likely to suffer respiratory complications     than infants born at term. The use of antenatal corticosteroids has been shown to improve     lung function in very premature infants, but has not been evaluated in those likely to     deliver in the late preterm period.      This research study will attempt to answer the following primary research question: Do     steroids, compared to no steroids, decrease babies' need for oxygen support when given to     pregnant women at least 12 to 24 hours before they deliver at 34 weeks to 36 weeks gestation?     The research study will also collect information on whether steroids improve the chances that     the baby will not get sick from other causes.   "
157414|NCT01222234|"     This investigation will consist of a prospective study utilizing two separate populations of     patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one     with normal renal function.   "
159537|NCT01195402|"     This randomised-controlled study is undertaken to investigate the effects of a long term low     intensity outpatient training program on physical fitness and quality of life in moderate to     severe COPD patients.   "
157415|NCT01223573|"     Apgar score is a subjective measure to assess prognosis and future outcome of a newborn.     Pulse oximetry taken at 1, 5 and 10 minutes will be correlated to apgar scores in respective     times in an goal to assess the usability of pulse oximetry as an added tool in determining     the newborn prognosis   "
157416|NCT01223560|"     The aim of this clinical study was to obtain type 1 diabetes data to identify models for     glucose prediction and control and to construct a physiological     pharmaco-kinetic/pharmaco-dynamic computer model of a type 1 diabetic person.   "
157417|NCT01223547|"     The investigators hypothesize that non-optimally treated carbohydrate counting-naïve patients     with type 1 diabetes can achieve better metabolic control by counting carbohydrates and that     the metabolic control can be further improved with concurrent use of an integrated glucose     meter and bolus calculator. The investigators want to test the hypothesis in this study.   "
157470|NCT01222819|"     Granulocyte colony stimulating factor (G-CSF) is frequently used among patients with cancer     including those with haematological malignancies.      Filgrastim is a recombinant human CSF whose biological activity is similar to that of     endogenous G-CSF.      In the treatment of chemotherapy-induced neutropenia in patients with various types of cancer     CSFs significantly reduced the time to neutrophil recovery and length of hospitalization.   "
157600|NCT01220804|"     The purpose of this study is to identify alterations of the blood-retinal barrier (BRB) in     diabetic retinas using a novel non-invasive approach based on the Fourier domain     high-definition optical coherence tomograph (OCT).   "
157418|NCT01223534|"     Hypothesis: a combined strategy of tuberculin skin test (TST) followed by QuantiFERON-TB Gold     In-Tube (QFT-IT) to confirm positivity (tuberculosis infection,in contact-tracing study will     allow avoiding unnecessary preventive treatment without increasing rates of tuberculosis     cases among contacts screened.      Aim of the study: to compare a combined strategy of the TST and the QFT-IT with TST alone for     the diagnosis of tuberculosis infection and for therapeutic decision in contact tracing     study.      Design and setting: Prospective, multicentre, comparative study in 12 hospitals in Spain.      Study population: 870 subjects, household contacts of patients with culture positive     pulmonary and/or laryngeal tuberculosis will be randomized to one of two strategies: Arm A     (standard practice), in which treatment decisions will be based on the TST result, and Arm B     (experimental), in which treatment decisions will be based on the QFT result.      Interventions: participants in arm A will undergo TST; participants in arm B will undergo     TST, and, in case of a positive result, QFT-IT as well. Participants with positive TST (arm     A) and positive QFT-IT (arm B) will be diagnosed with tuberculosis infection and will be     treated with isoniazid for 6 months. All participants will be followed for two years.      End-points of evaluation: development of tuberculosis and proportion of subjects for whom     treatment is prescribed in each arm.   "
157419|NCT01223521|"     A randomized prospective study on the effects of immediate provision of intrauterine     contraception after first trimester induced abortion - effects on repeat abortions and     quality of life.   "
157420|NCT01223482|"     Studies have shown that a majority of pregnancies that end in miscarriage are due to a     chromosome abnormality usually involving a duplicated or missing chromosome. Often this     happens by chance and is not likely to occur in future pregnancies. For many women, a     miscarriage can be a traumatic experience and can cause feelings of loss and grief. The     option of genetic testing, such as karyotyping, may offer an explanation for the miscarriage     and may help some women find closure in their loss. However, no literature exists on a     women's experience with genetic testing following a miscarriage. This assumption that the     knowledge that can be gained from karyotyping may be a positive experience for a woman     following a miscarriage should be studied and the results published. This study will address     whether routine karyotyping should be offered following a miscarriage for the purpose of     benefiting the patient's experience.   "
157421|NCT01223469|"     The main objective of this study is to demonstrate the clinical safety of a contact force     sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and     atrial fibrillation. In addition, the study will characterize the use and value of contact     force measurement during ablation, and the long term success (12 months) of the ablation     procedure using this technology.   "
157422|NCT01223456|"     This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA     under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2     and are prescribed ONGLYZA by their physician.   "
157423|NCT01223443|"     Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac     events (death, myocardial infarction, target vessel revascularization) over the duration of     follow-up.      Primary objective: To evaluate the efficacy of stenting moderate SVG lesions with     paclitaxel-eluting stents on reducing the first occurrence of the composite of cardiac death,     myocardial infarction or repeat revascularization related to the target SVG over the duration     of follow-up (minimun of 2-year follow-up.   "
157424|NCT01223430|"     The purpose of this study is to determine whether simultaneously using the traditional     Chinese medicine, Si-Ni-Tang, is more effective in the treatment of septic shock patients.   "
157425|NCT01223404|"     Many disorders where attentional problems are a hallmark, such as Alzheimer's disease and     schizophrenia, display abnormal regulation of the so-called default network of resting brain     function that maintains internally directed thought when the mind is free to wander. These     regions can be overactive or less readily deactivated with attention-demanding tasks, and     excess activity is thought to impair performance. There is indication that nicotine may     improve attention by aiding the deactivation of the default network, and this mechanism may     be of therapeutic benefit for the above disease states. The current project aims at providing     a proof of concept by demonstrating that nicotinic drugs modulate default network function.     The nicotinic agonist nicotine is hypothesized to improve attention by facilitating the     down-regulation of default network activity, and the nicotinic antagonist mecamylamine is     hypothesized to impair attention by impeding the down-regulation of default network activity     during attentional task performance.   "
157426|NCT01223391|"     The purpose of this study is to assess if abdominal binders that use pull strings to adjust     compression (non-elastic) are more effective than standard elastic abdominal binders in     attenuating neurogenic orthostatic hypotension.   "
157427|NCT01223378|"     The objective of this clinical investigation is to determine the most effective drug     concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical     development of an appropriate dose with regard to efficacy, and ocular and systemic safety.   "
157428|NCT01223365|"     The primary objective of this study is to evaluate the safety of hydrocodone extended-release     tablets when used over a 12-month period in patients with chronic pain, as assessed by     adverse events, clinical laboratory results, vital signs measurements, electrocardiogram     results, physical examination findings, pure tone audiometry, and concomitant medication     usage.   "
159538|NCT01195389|"     The purpose of this study is to determine if low level magnetic fields can help to improve     memory in patients diagnosed with Alzheimer's dementia.   "
157430|NCT01223339|"     This study is to characterize the pharmacokinetics, safety, tolerability, and     pharmacodynamics of single and multiple oral doses (SD, MD) of ertugliflozin (PF-04971729,     MK-8835) in Japanese healthy participants. The secondary objective is to investigate the     safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ertugliflozin     in Western healthy participants as compared to Japanese healthy participants.   "
157431|NCT01223326|"     Study hypothesis: N-acetylcysteine (NAC) can reduce ischemia/reperfusion injury in liver     resection performed under ischemic preconditioning and intermittent portal triad clamping.   "
157601|NCT01220791|"     Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently     control late follicular progesterone rise during IVF treatment   "
157432|NCT01223313|"     WHAT IS THE FEMALE CONDOM? The female condom being examined in this study is investigational     (experimental) and is not yet approved by the Food and Drug Administration (FDA). The female     condom is made up of a pouch that adjusts to the shape of the vagina. The female condom that     will be used in this study is not lubricated, but a water-based lubricant will be provided     for you to use with it. Also, the female condoms used in this study will be provided to you     at no cost.      WHY IS THIS STUDY BEING DONE?      The purpose of this study is to find out:        -  How well the female condom works to prevent pregnancy        -  How well the female condom works to prevent transmission of sexually transmitted          diseases        -  How safe the female condom is to use        -  If urinary tract infections and symptomatic vaginal infections occur while using the          female condom        -  How well women like the female condom        -  How well the female condom performs.      WHAT DOES THE STUDY INVOLVE? There will be approximately 10 clinics in the study with about     500 women from all over the United States participating in this study. You are being asked to     participate in a research study because you are a woman between the ages of 18 and 40, are in     general good health, have regular menstrual cycles, do not want to become pregnant for at     least the next 7 months, and are willing to rely on the female condom as your primary method     of contraception during study participation.      HOW LONG DOES THE STUDY LAST? Enrollment for this study is expected to last about 12 months.     You will need to come to the clinic for a screening/admission visit and then 2 or more     visits. You will also be asked to complete a diary every day about your use of the female     condoms. The clinical staff will help set up your planned clinical visits during the study.   "
157433|NCT01223300|"     The aim of this research registry is to collect information on individuals with osteoporosis,     those with risk factors for osteoporosis, and comparative healthy controls. Bone mineral     density measurements will be done on these individuals to determine bone health.   "
157434|NCT01223287|"     This observational study was conducted to design and test a physiologic definition for     bronchopulmonary dysplasia at 36 weeks of life. Infants were studied in a supine position     with the pulse oximeter in position with good signal prior to collecting baseline data.     Feedings and medications were given 30 minutes before the evaluation. Baseline data was     collected on infant's current oxygen. Then, the infants were weaned to room air for 30     minutes. If saturations remain ≥90%, the infant was considered to have passed the oxygen     reduction challenge (to NOT have BPD). The infant should then be placed back in his/her     baseline oxygen. If the infant has saturations <90% for 5 continuous minutes or <80% for 15     seconds, the infant should be immediately placed back in his/her baseline oxygen, and the     infant was considered to have NOT passed the challenge (to have BPD).   "
157435|NCT01223274|"     This pilot study was designed to determine the feasibility of randomizing extremely low birth     weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two     resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway     pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure     (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP     and no PEEP if the infant required PPV (the control group).   "
157436|NCT01223261|"     The purposes of this study were: 1) to compare mortality and postoperative morbidities in     extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for     necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the     ability to distinguish NEC from IP preoperatively and the importance of this distinction on     outcome measures; and 3) to evaluate the association between extent of intestinal disease     determined at operation and outcome measures. All ELBW infants born at participating NRN     centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon     and neonatologist to require surgical intervention. Data were collected enrolled infants,     including: intraoperative findings recorded by the surgeon and specific post-operative     complications. Neurodevelopmental examinations were conducted on surviving infants at 18-22     months corrected age.   "
157437|NCT01223248|"     The purpose of this study is to find out which way of giving high-dose radiation works best     for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. This     study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days)     or 24 Gy in one fraction (1 day) using image-guided intensity-modulated radiotherapy     (IG-IMRT). IG-IMRT is radiation that is given directly to the cancer site and reduces the     exposure to normal tissue. Currently there are no studies that compare the effects of giving     radiation in either hypofractionated doses (higher total doses of radiation spread out over     several treatment days) or a single-fraction dose (entire radiation dose given in one     treatment session).      The patient may be asked to participate in an additional part of this study where we will get     a a (DW/DCE) MRI before treatment start and within one hour after radiation treatment. If the     patient is asked to take part in this portion of the study, all they will need to do is get     up to 3 MRIs with standard contrast injection. The purpose of this is to see if as a result     of the treatment there are changes in the blood flow going to the cancer which could suggest     that the treatment may be successful.      In addition some patients can present new lesions and may be asked if they would like to have     these new lesions treated on the protocol. If they are given this option, this will not     extend their follow up period. The follow up of the new lesions will match with the prior     follow up dates.   "
157438|NCT01223235|"     The immune system of the body has the ability to fight and eliminate infections and cancers.     Immune treatments, such as in this study, seek to teach the immune system to find and destroy     cancer cells. The purpose of this study is to test whether it is safe to treat the cancer     with a vaccine and another drug called bevacizumab (also known as Avastin).   "
181908|NCT00226681|"     To determine if an education and support nursing intervention program helped sudden cardiac     arrest survivors adjust to the event and to getting an ICD   "
157440|NCT01223209|"     This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001).     This will be tested in patients that have had surgery with curative intent for malignant     tumour.      GV1001 is a peptide vaccine in development to treat cancer. An adjuvant, is required to start     the immune response in the body to have effect of GV-1001.      LTX-315, also a peptide, in development for cancer treatment. In this study, the     investigators wish to find out whether LTX-315 can make GV1001 more effective at stimulating     the immune system.   "
157441|NCT01223196|"     Background: Pioglitazone has been shown to have potent anti-inflammatory as well     anti-atherosclerotic effects. However, the mechanisms by which pioglitazone exerts these     effects are not clear. The investigators propose that Tissue Inhibitor of MetalloProteinase-3     (TIMP-3) and TNF-alfa converting enzyme (TACE) play a major role in pioglitazone mediated     improvement in insulin sensitivity and endothelial function. In animal models, low dose     pioglitazone inhibits lesion progression and matrix metalloproteinase expression in advanced     atherosclerotic plaques. The investigators believe that a lower dose of Pioglitazone will     also have anti-inflammatory effects.      Aim: To examine the effect of low dose Pioglitazone (15mg/day) on TIMP and TACE in     Pioglitazone mediated improvements in insulin sensitivity.      Methods: Thirty subjects with T2DM will participate in following studies: (i) oral glucose     tolerance test (OGTT); (ii) Dual energy absorptiometry(DXA) for body fat content, (iv)     skeletal muscle biopsy. Subjects will be randomized to receive either placebo or pioglitazone     for 24 weeks. The investigators will study the effect of Pioglitazone on (1) TIMP and TACE     substrate activity in skeletal muscle, adipose tissue, mononuclear cells, and their     relationship to insulin sensitivity and vascular reactivity, other adipocytokines- resistin,     TNF-α and Visfatin; (2) markers of inflammation and atherosclerosis- C-reactive protein,     VCAM-1 (vascular cell adhesion molecule 1), ICAM-1 (Intercellular Adhesion Molecule 1),     endothelin 1, E-selectin, P-selectin, TNFrecI (Tumor Necrosis Factor Receptor I), TNFrecII     (Tumor Necrosis Factor Receptor II), IL-6 (Interleukin 6) receptor.   "
157442|NCT01223183|"     Blockage of the breathing tubes of the lungs by thick, sticky mucus is a major cause of lung     problems for people with cystic fibrosis (CF). Many researchers now believe that people with     CF absorb too much water from the insides of their lungs, and that the mucus in their lungs     becomes so thick and sticky because there is not enough water in it. The investigators are     trying to develop ways to measure how fast water is absorbed from the breathing tubes in the     lung so that the investigators can more quickly test new medications that are being developed     to fix this problem for CF patients. The investigators have already done studies showing that     people with CF absorb a particular radioactive drug (Indium-111 DTPA or In-DTPA) from their     lungs more quickly than people without CF. Now the investigators are trying to prove that the     absorption of this drug is related to the absorption of water. The investigators measure the     absorption of In-DTPA by delivering it in an aerosol (inhaled mist) along with another     radioactive drug (Technetium 99m sulfur colloid). This other drug helps us measure how much     material is cleared from the lungs in other ways (like coughing) without being absorbed. In     this study, the investigators will measure how the absorption of In-DTPA is affected by     inhaling isotonic saline and hypertonic saline (salt water), both of which the investigators     know affect the absorption of water in the airways.   "
157443|NCT01223170|"     Cardiovascular Diseases (CVD) according to the World Health Organization (WHO) are leading     causes of death and represent 30% of all global deaths and 48% of the deaths in Europe.     Moreover, the current trends predict increase in deaths caused by Cardiovascular Diseases     over the next years. Secondary preventive efforts can decrease mortality risk as well as     improve health among Cardiovascular Disease patients.      This study suggests an innovative approach in supporting the self-management of     Cardiovascular Disease patients after rehabilitation. The implied Randomized Controlled Trial     has two arms and aims to investigate the effectiveness of tailoring in an Information and     Communication Technology (ICT) based intervention. The tailoring will be based on concepts     derived from health psychology theories, and will contribute in their further development.     More specifically:        -  Aim 1: To assess the needs of CVD rehabilitation patients that can potentially be met          through the use of ICT.        -  Aim 2: To assess the effects of a tailored Internet-based intervention on maintenance of          self-management behaviors after a rehabilitation stay. Hypothesis: The intervention          group (tailored) will have higher adherence a) to the Internet-based intervention, and          b) to self-management.        -  Aim 3: To assess the effect of mobile technology with activity sensors on physical          activity. Hypothesis: There will be a relationship between the data collected from          activity sensors and the self-reported physical activity levels.   "
157444|NCT01223157|"     Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive     procedures. The investigators managed in the lab to determine the levels of endocannabinoids     in a small number of subjects. The aim of the study is to confirm that salivary is a useful     tool to evaluate the activity of the ECS both in normal weight and obese subjects that are     characterised by a hyperactivity of the system. Therefore, the first objective of the study     is to compare the fasting level of salivary anandamide between 12 obese patients and 12     normal weight subjects.   "
157445|NCT01223144|"     The present study aims at investigating cognitive functions requiring orbitofrontal control,     namely decision-making and facial emotion recognition. The investigators hypothesize that     decision-making and facial emotion recognition are impaired in patients with essential tremor     (ET) due to frontal lobe dysfunction which may have consequences in daily social life.   "
157463|NCT01222910|"     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover, bioequivalence study comparing valacyclovir     hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX®     caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in healthy,     adult, male, human subjects under fasting condition.   "
157464|NCT01222897|"     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover, bioequivalence study comparing Valacyclovir     hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX®     caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in healthy,     adult, male, human subjects under fed condition.   "
182766|NCT00235001|"     This study will investigate antihypertensive activity and safety profile of Tarka in Russian     hypertension patients by ambulatory blood pressure measurement (ABPM)   "
157489|NCT01222572|"     In this research study the investigators are looking for the highest dose of a stereotactic     radiation boost that can be given safely. Because stereotactic radiation is so precise, the     investigators are testing whether it can be used to increase the dose to the primary tumor     without significantly increasing the side effects the participant experiences; the goal is to     improve the likelihood of killing the tumor.   "
157446|NCT01223131|"     Primary Objective:      6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin     (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM)     aged at least 6 years to less than 18 years.      Secondary Objectives:        -  To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:             -  Percentage of patients reaching International Society of Pediatric and Adolescent               Diabetes (ISPAD) recommended target of HbA1c < 7.5%,             -  Fasting blood glucose (FBG),             -  Nocturnal blood glucose (BG),             -  24-hour blood glucose profile based on 8-point self-monitoring of blood glucose               (SMBG) values,             -  Daily total insulin dose and basal insulin dose,             -  Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal               symptomatic hypoglycemia.        -  To assess the safety and tolerability of insulin glargine versus NPH insulin based on          the occurrence of treatment-emergent adverse events (TEAEs).        -  To assess anti-insulin and anti-glargine antibody development in both groups.        -  To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin          glargine in selected sites with approximately 45% of insulin glargine population to rule          out accumulation tendency of insulin glargine after repeated dosing   "
157447|NCT01223118|"     The purpose of this study is to determine the rate of cryosurvival of mature oocytes     following vitrification, and to then compare the reproductive potential of vitrified oocytes     relative to those which have not been cryopreserved.   "
157448|NCT01223105|"     This study seeks to evaluate whether the vitrification technique, as compared to the more     traditional slow-cooling technique, leads to higher rates of successful thawing,     fertilization, implantation and delivery.   "
157449|NCT01223092|"     The purpose of this this study is to use DNA screening strategies to identify genes and     localize genomic regions that are differentially expressed in patients with infertility to     further understand the genetic basis for reproductive competence.   "
157450|NCT01223079|"     The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the late     follicular phase of young women undergoing controlled ovarian stimulation for oocyte     donation.   "
157451|NCT01223066|"     The study objective is to evaluate the long term safety when Macrolane Volume Restoration     Factor is used in female breasts in clinical practice.   "
157452|NCT01223053|"     Transdel Pharmaceuticals is investigating a topical cream formulation consisting of 10%     ketoprofen for the local treatment of pain associated with mild to moderate acute soft tissue     injury in this confirmatory Phase 3 trial.   "
157453|NCT01223040|"     The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane     Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye     patients.   "
157454|NCT01223027|"     This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients     with metastatic renal cell cancer.   "
157455|NCT01223014|"     Phase I study to evaluate the excretion of radioactivity, the metabolic profile,     pharmacokinetics, safety and tolerability following a single oral administration of     [14C]AZD2423 in healthy male volunteers aged 50 to 65 years (inclusive).The purpose of this     study is to investigate how and how quickly AZD 2423 or its break down products are excreted     by analysing blood, faeces and urine samples collected during the study.   "
157456|NCT01223001|"     The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth     daily with placebo in the prevention of depression associated with mild/moderate traumatic     brain injury and to enhance cognitive function.   "
157457|NCT01222988|"     Obtain a preliminary assessment of the feasibility and acceptability of delivering the     sustained lost weight (SLW) intervention in a real-world clinical setting for patients who     have completed a 21-week very low calorie diet (VLCD).      Hypothesis: Intervention will be feasible to implement as evidenced by the ability to recruit     and retain participants and acceptable to participants as evidenced by self-report of     satisfaction with the program and adoption of weight maintenance behaviors.      Secondary Aim: Obtain a preliminary assessment of the effectiveness of the sustained lost     weight (SLW) intervention for patients who have completed 21 weeks of a very low calorie diet     (VLCD).      Hypothesis: Greater than 75% of participants who receive this novel approach, where     maintenance behaviors are individualized based on resting metabolic rate and a physical     activity factor, will regain greater or equal to 10 kg. at week 52 follow-up.   "
157458|NCT01222975|"     The purpose of this study is to determine the pharmacokinetics and bioequivalence of     Risperidone formulations after administration of single doses to normal, healthy subjects     under fasted conditions.   "
157459|NCT01222962|"     The study was designed to assess the effect of food on the extent and rate of absorption of     Dihydroartemisinin (DHA) and Piperaquine Phosphate (PQP) administered as a fixed dose     combination (Eurartesim™).   "
157460|NCT01222949|"     The Study was designed to evaluate the pharmacokinetics of DHA and PQ in healthy volunteers     and to assess the effect of ethnicity (Asian vs Caucasian), gender and body weight on the     relative bioavailability of DHA and PQ.   "
157461|NCT01222936|"     SCLC is the most aggressive and lethal form of lung cancer, typically very sensitive to     cytotoxic therapy when first diagnosed, but associated with a high incidence of tumour     relapse and a very poor life expectancy. Combination chemotherapy based on cisplatin or     carboplatin and etoposide represents the most widely used regimen. Despite of the high     response rate, approximately 80% of patients with limited disease and nearly all patients     with extended disease develop disease relapse or progression. Topotecan is, at present, the     only approved second line treatment in Europe.      The search of a new therapeutic agent that could alter the natural history of SCLC would be     an important goal to be reached. LBH589 (Panobinostat) is a histone deacetylase (HDAC)     inhibitor available for intravenous and oral administration. LBH589 could be classified as     PAN-DAC inhibitor targeting both histone and non histone proteins and as such it could be     suitable for combination with cytotoxics. Three phase I dose escalation studies with both the     intravenous and the oral formulation of LBH589, examining various dose schedules of     administration have been conducted in advanced solid tumours and haematological malignancies.      Single agent activity was observed in phase I in patients with haematological cancer. In     solid tumours one response (Hormone-refractory Prostatic Cancer) and some prolonged     stabilizations have been observed with intravenous formulation. Phase II studies are now in     progress.   "
157471|NCT01222806|"     Background:      - Cocaine addiction is often difficult to treat, particularly because exposure to others     using cocaine or to pictures of cocaine may evoke cocaine craving and lead a person to resume     cocaine use after having quit. Breaking this link with cocaine craving might improve     treatment for cocaine addiction. Research suggests that repetitive pulses of transcranial     magnetic stimulation (rTMS) applied to the skull can change nerve cell firing in the brain.     rTMS was recently approved as a treatment for depression, and is being studied as a way to     reduce drug craving. However, because only a few small studies have looked at the effects of     rTMS on cocaine craving, more research is needed on whether it is effective in reducing     cocaine craving and use in individuals who currently use cocaine on a regular basis.      Objectives:      - To determine whether transcranial magnetic stimulation can lower craving for cocaine when     given in connection with cocaine-related images.      Eligibility:      - Individuals at least 18 years of age who have used cocaine for at least 2 years and     currently using at least 3 times per week.      Design:        -  This study involves an initial screening visit, two brain imaging sessions, five rTMS          sessions, and two follow-up visits.        -  Participants will be screened with a medical history, physical examination, urine          samples, questions about drug use history and previous efforts to quit, and tests for          breath alcohol and nicotine levels.        -  Participants will have two magnetic resonance imaging (MRI) scan sessions: one baseline          scanning session before starting their rTMS sessions and a second scanning session after          their last rTMS session . Part of each scanning session involves functional MRI (fMRI)          scans. During the fMRI scans, participants will look at pictures related to cocaine use          and pictures that are not related to cocaine use. Participants will also perform a          simple decision task during the scans.        -  Participants will have five rTMS sessions, one per day for 5 days in a row. Each session          will last 1 to 2 hours. Participants will have either real or sham (simulated) rTMS          while looking at pictures that may or may not be related to cocaine use, and will also          perform a simple decision task that is the same as the one given during the MRI scans.          The decision as to whether participants get real or sham rTMS will be made by chance.          Neither the participants nor the investigators will know which type the participants are          getting. - Participants will have two follow-up visits one and two weeks after their          last rTMS session. At each visit they will be checked for cocaine and other substance          use and for possible side-effects from rTMS.   "
157472|NCT01222793|"     Background:      - Although second-generation antipsychotic medications have fewer serious side effects and     complications than first-generation ones, they are strongly associated with weight gain for     reasons that are as yet unknown. Comparing the effects of second-generation antipsychotics     with a high weight-gain liability (HWGL) low weight-gain liability (LWGL) antipsychotics may     provide more information on which medications are best suited for different individuals.     Researchers are interested in studying how people taking various antipsychotics compare with     controls in regard to food craving and eating behavior. This knowledge should help to guide     practitioners when advising patients about the weight-gain effects of these medications.      Objectives:      - To examine eating behavior and food craving in patients with schizophrenia who are taking     HWGL antipsychotics compared with those taking LWGL antipsychotics and with healthy controls     taking no antipsychotics.      Eligibility:        -  Individuals between 18 and 45 years of age who have been diagnosed with schizophrenia or          a related disorder, have a body mass index between 25 and 29.9, and have never had an          eating disorder.        -  Healthy individuals between 18 and 45 years of age who have a body mass index between 25          and 29.9 and have never had an eating disorder.      Design:        -  This study involves an initial screening visit and four study visits.        -  Participants will be screened with a medical history and physical examination, as well          as questionnaires about stress levels, food cravings, smoking, exercise, and eating          habits; a taste test; and saliva collection (to measure stress hormones).        -  Visit 2: Participants will have an optional overnight stay, and will provide blood          samples before having a breakfast beverage and answering questions about tiredness,          anxiety, hunger, and alertness during a 1.5 hour session.      Visit 3: Participants will have an optional overnight stay and a light breakfast, followed by     blood draws and questions about hunger and food cravings.      Visit 4: Participants will have an optional overnight stay, followed by questions about food     preference. Participants will not be allowed to eat until mid-morning of the next day.      Visit 5: Participants will eat normally before arriving at the research site, and will have     tests to measure food craving and questionnaires about mood and feelings.   "
157473|NCT01222780|"     Background:        -  Marqibo(Registered Trademark) is a new anticancer drug. It combines Vincristine sulfate,          which is a widely used anticancer drug, and packages it into a tiny fat bubble known as          a liposome. The goal of this is to improve the drug's ability to destroy cancer cells          and help reduce the potential side effects of treatment.        -  Vincristine sulfate was originally developed from chemicals found in the periwinkle          plant and acts against multiple types of malignant cancer. It is approved for multiple          cancer types including solid tumors and blood cancers.        -  Research has shown that Marqibo(Registered Trademark) is able to slow or stop the growth          of cancer cells in some adults, both alone and in combination with other chemotherapy          drugs, but more research is needed to determine its use in children.        -  There has been one previous small study of Marqibo(Registered Trademark) in children.          Although some anti-cancer activity was seen, side effects and optimal dosing were not          fully determined.        -  As is seen with standard Vincristine suflate, the most common side effect of          Marqibo(Registered Trademark) involves the nervous system. It can cause numbness and          tingling in the hands and feet. Symptoms commonly improve when the drug is discontinued          or the dose is lowered.      Objectives:      - To determine the safety and efficacy of Marqibo as a treatment for children who have been     diagnosed with certain types of malignant cancer that has not responded to standard     treatment.      Eligibility:        -  Children and adolescents between 2 and 21 years of age who have been diagnosed with          certain types of malignant cancer that has not responded to standard treatment.        -  These cancer types include solids tumors, primary brain tumors, leukemias, and          lymphomas....   "
157474|NCT01222767|"     This is a phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis®     (PM00104) in Patients with Unresectable Locally Advanced and/or Metastatic Ewing Family of     Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy to determine the     antitumor activity of Zalypsis.   "
157475|NCT01222754|"     Background:      - Children who are diagnosed with brain tumors known as high grade gliomas or diffuse     intrinsic pontine gliomas are generally treated with radiation therapy and chemotherapy.     However, these tumors are very difficult to cure, and the tumor frequently begins to grow     again even after treatment or surgery. Researchers are interested in determining whether the     anticancer drug lenalidomide, which has been used to treat other aggressive types of cancer,     is a safe and effective additional treatment for children who are scheduled to receive     radiation therapy to treat high grade gliomas or diffuse intrinsic pontine gliomas.      Objectives:      - To determine the safety and effectiveness of lenalidomide, in conjunction with radiation     therapy, as a treatment for children who have been diagnosed with high grade gliomas or     diffuse intrinsic pontine gliomas.      Eligibility:      - Children and adolescents up to 21 years of age who have been diagnosed with high grade     gliomas or diffuse intrinsic pontine gliomas and have not had radiotherapy or chemotherapy.      Design:        -  Participants will be screened with a medical history, physical examination, blood and          urine tests, and imaging studies.        -  Participants will have two phases of treatment: a lenalidomide plus radiation phase and          a lenalidomide-only phase.        -  During the radiation phase, participants will take lenalidomide daily and have 6 weeks          of radiation therapy (five treatments per week). After the radiation therapy,          participants will stop taking lenalidomide for 2 weeks before continuing to the next          phase.        -  During the lenalidomide-only phase, participants will take lenalidomide daily for 21          days, followed by 7 days without lenalidomide (28-day cycle of treatment). Participants          will have up to 24 cycles of lenalidomide.        -  Participants will have frequent blood tests during the first cycle of treatment, and          will have imaging studies or other tests as required by the study researchers.        -  Treatment will continue until the disease progresses, the participant chooses to leave          the study, or the researchers end the study....   "
157519|NCT01221857|"     Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a     UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second,     Unmanipulated CBU in Patients with Hematological Malignancies   "
157523|NCT01221805|"     The purpose of this study is to demonstrate the ability of STA® Liatest® D-Di combined with a     clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous     Thrombosis (DVT) in a 3 month follow-up.   "
157490|NCT01222559|"     This is a prospective, phase III, multicenter, open label, randomised clinical trial of     co.don chondrosphere®, a three-dimensional autologous chondrocyte transplantation product     (ACT3D-CS)compared to the procedure of microfracture (MF)in the treatment of cartilage     defects of knee joints.      After screening visit patients were booked for arthroscopy and at that time they were     randomised to either ACT3D-CS with co.don chondrosphere® (Group A) or to MF(Group B), a     marrow-stimulating method based on the penetration of the subchondral bone plate at the     bottom of the cartilage defect. At the time of arthroscopy Patients of group B had their     procedure of MF (treatment surgery) and patients of group A had their cells harvested from     healthy cartilage. The cells are cultivated for 8-10 weeks in vitro to develope 3-dimensional     spheroids , that are transplanted in an open knee procedure (treatment surgery)into the     defect. Patients subsequently followed the same rehabilitation program and had post-surgery     visits. After the 12-month-visit a interim analyses will be performed and the 24-month-visit     is defined as final assessment. Then patients have follow-up assessments up to 60 months     post-treatment-surgery.   "
157477|NCT01222728|"     Background:        -  Neurofibromatosis type II (NF2) is associated with tumors of the nerves, brain, and          spinal cord. Most people with NF2 develop vestibular schwannomas, or tumors on the          hearing and balance nerves. As they grow, vestibular schwannomas can cause hearing loss          and balance problems. If they grow very large they can cause more serious problems, such          as seizures, loss of eyesight, weakness, speech problems, and problems with the sense of          touch. More research is needed into NF2 because researchers do not completely understand          why these tumors occur or what makes them grow over time.        -  Currently, tumor size is measured with magnetic resonance imaging (MRI) scans. However,          MRI scans cannot predict how fast a tumor will grow. By using positron emission          tomography (PET) scanning, researchers hope to be able to predict sudden growth spurts          of tumors associated with NF2 and develop better treatment methods for this type of          cancer.      Objectives:      - To use magnetic resonance imaging and positron emission tomography to better understand the     growth of brain tumors in people with neurofibromatosis type II.      Eligibility:      - Individuals between 18 and 50 years of age who have been diagnosed with NF2 and have at     least three untreated intracranial tumors.      Design:        -  This study requires an initial set of outpatient visits to the NIH Clinical Center that          will last 7 to 10 days.        -  Participants will have a physical and neurological examination and blood tests at the          first visit. Participants will then have the following imaging studies to examine the          tumors:        -  MRI scans of the brain        -  PET scans of the brain, combined with a computed tomography (CT) scan. The PET scans          will be performed on separate days. Different contrast agents will be used for both          scans, so researchers will inform participants if they need to fast or follow other          procedures before having the scan.        -  After the initial imaging studies, participants will have additional MRI scans every 6          months for 2 years to track tumor growth.   "
157478|NCT01222715|"     This randomized phase II trial studies how well vinorelbine tartrate and cyclophosphamide     work in combination with bevacizumab or temsirolimus in treating patients with recurrent or     refractory rhabdomyosarcoma. Drugs used in chemotherapy, such as vinorelbine tartrate and     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Bevacizumab may also stop the growth of rhabdomyosarcoma by blocking blood flow to the tumor.     Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. It is not yet known whether combination chemotherapy is more effective when     given together with bevacizumab or temsirolimus in treating rhabdomyosarcoma.   "
157479|NCT01222702|"     Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated     diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the     study was to evaluate the efficacy and safety of different doses of cadazolid in order to     find the dose of cadazolid to be used for further clinical development of the compound in     subjects with CDAD.   "
157480|NCT01222689|"     This phase II trial studies how well giving selumetinib and erlotinib hydrochloride together     works in treating patients with locally advanced or metastatic pancreatic cancer that is     refractory to chemotherapy. Selumetinib and erlotinib hydrochloride may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth.   "
157481|NCT01222676|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.     Giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate may kill more     tumor cells. Giving them before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving cisplatin and gemcitabine     hydrochloride together with sorafenib tosylate works in treating patients with node-negative     transitional cell cancer of the bladder.   "
157482|NCT01222663|"     The purpose of this randomized, comparative, open and multi-centre study is to show that two     sessions of hemoperfusion with Toraymyxin performed within maximum 36 hours after the surgery     of a peritonitis by hollow organ perforation reduce the mortality in patients suffering from     septic shock.   "
157483|NCT01222650|"     The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to     placebo for the treatment of LUTS caused by BPH.   "
157484|NCT01222637|"     This is a prospective, open label, multicenter study evaluating the safety, tolerability and     pharmacokinetics of CetuGEX™ after intravenous administration in patients with EGFR positive,     locally advanced and/or metastatic solid cancers. The effect of CetuGEX™ on the development     of anti-drug antibodies and on tumour response will also be evaluated.   "
157485|NCT01222624|"     This is a prospective, open label, dose escalating, multicenter, phase I study measuring the     safety, tolerability, and pharmakokinetics of PankoMab-GEX™ after intravenous administration     in patients with locally advanced or metastatic solid cancers refractory to standard     treatment. The effect of PankoMab-GEX™ on the development of antibodies and tumor response     will also be evaluated.   "
157486|NCT01222611|"     This study examines the impact of fosamprenavir as part of an ART on virological,     immunological and clinical parameters of genotype 1 HCV infection in HIV co-infected     subjects. Fosamprenavir could have a direct or immune-mediated activity against HCV. If this     is shown to be true, changes in HCV viral load or biological characteristics could be     demonstrated.   "
157487|NCT01222598|"     This is a confirmation of safety profile for Minirin Melt in clinical practice.   "
157524|NCT01221792|"     The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac     effect, will reduce symptoms of Post Traumatic Stress Disorder.   "
157488|NCT01222585|"     Yearly in the United States over 500,000 newborns are delivered prematurely. This population     is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants     with necrotizing enterocolitis are at high risk of death, and survivors are at increased risk     of mental retardation. Metronidazole is an antibiotic that is often administered to infants     with suspected or confirmed necrotizing enterocolitis. Unfortunately, the appropriate dose of     metronidazole in premature infants has not been established and it is likely to be different     from older children and adults.      The investigators will investigate the appropriate metronidazole dose in very premature     infants by: 1) determining how premature infants eliminate metronidazole from the body and 2)     determining the safest and most effective dose of metronidazole in premature infants.      The investigators hypothesis are: 1) The rate of removal of metronidazole will increase with     infant maturity and 2) an appropriate metronidazole dosing regimen will result in necessary     drug levels to treat bacteria involved in necrotizing enterocolitis.   "
157530|NCT01221714|"     To evaluate the safety and tolerability of two supplements in healthy subjects taken daily     for six months.   "
157491|NCT01222221|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine     therapy together with temozolomide and radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given     together with temozolomide and radiation therapy in treating patients with newly diagnosed     glioblastoma multiforme.   "
157492|NCT01222208|"     A prospective, randomized controlled study, using stable isotope methodology, is proposed to     determine whether an oral nutrition support regimen, containing pressurized whey protein and     glucose, is more effective at normalizing the metabolic response to surgery than a standard     peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in     colorectal surgical patients studied before and after surgery. The effectiveness of the     nutrition support regimens will be determined by: whole body protein balance, synthesis rates     of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well     as circulating metabolites concentrations.   "
157493|NCT01222195|"     The goal of this clinical research study is to learn if lenalidomide and darbepoetin alfa     given together will help to control the need for transfusions in patients with low to     intermediate risk Myelodysplastic Syndrome (MDS). The safety of this combination will also be     studied.   "
157494|NCT01222182|"     A group of ~ 225 patients were switched from atorvastatin to an equivalent statin either by     their physicians usual management or by an collaborative pharmacist coordinated process. We     will compare the results of pharmacist process to the standard medical practice to find     potentially which process is more effective, safer and efficient. We are surveying a total of     35 physicians, 12 using the pharmacist coordinated process and 23 not, comparing their     satisfaction of the 2 processes.   "
157495|NCT01222169|"     To describe respiratory and laryngeal responses to laryngeal stimulation during propofol     anesthesia in children. To determine whether the co-administration of lidocaine blunts these     reflex responses. The outcome of primary interest is the reflex laryngospasm.      Hypotheses:      I: The severity of laryngospasm evoked by laryngeal stimulation is reduced 2 min. after iv.     administration on 2mg/kg lidocaine in pediatric patients anesthetized with propofol     (3mcg/ml).      II:The incidence of laryngospasm elicited by controlled stimulation 10min. after iv.     administration of lidocaine is equivalent to the response before the administration of     lidocaine.   "
157496|NCT01222156|"     The Magnetecs Catheter Guidance Control and Imaging (CGCI) system is a magnetic remote     navigation system which is comprised of a magnetic chamber of eight electromagnets around the     patient torso. The system can change the magnetic field almost instantaneously and enables     almost real time manipulation of a special magnetic catheter (Maxwell mapping catheter) which     results in accurate, repeatable, rapid and safe target acquisition within the four chambers     of the human heart.      The trial is a prospective, non-randomized, clinical one designed to test the study     hypotheses of (a) technical equivalence of the study device in comparison to other magnetic     remote navigation systems, (b) performance equivalence or non-inferiority of the study device     target acquisition capability compared to presently used catheter navigation techniques, and     (c) safety equivalence or non-inferiority of the study device in comparison to catheter     navigation devices using other navigation techniques.   "
157520|NCT01221844|"     The purpose of this study is to determine whether bovine lactoferrin is effective in     preventing and curing iron deficiency and iron deficiency anemia in Hereditary Thrombophilia     affected women during pregnancy.      The proposed clinical trial is considered as PHASE IV because in Italy bLf is commercialized     by Grunenthal, as Lattoglobina® (capsules with 100 mg of bLf), to prevent and cure iron     deficiency and iron deficiency anemia in pregnant women.   "
157497|NCT01222143|"     This is a phase I/II open-label study that is evaluating the toxicity and efficacy of     nilotinib combined with mitoxantrone, etoposide, and high-dose cytarabine (NOVE-HiDAC)     chemotherapy for patients with poor-risk acute myeloid leukemia (AML). There are two parts to     the study. The first part (Phase I) will determine the maximum dose of nilotinib that can     safely be given when combined with NOVE-HiDAC. This dose will then be used in combination     with the NOVE-HiDAC regimen in the second part of the study (Phase II), which will evaluate     the antileukemic activity of the treatment. The patients who achieve complete remission from     the induction therapy (1 cycle) will then receive consolidation therapy combined with     nilotinib (maximum of 2 cycles).      The patient population for this study will have AML and will fall into a poor risk category.     This means they have persistent leukemia after induction therapy, they relapse within two     years of achieving complete remission with induction therapy, or they have certain poor risk     features at diagnosis. The AML cells will also be positive for c-kit (a stem cell factor     receptor), which is involved in cancer cell growth. Nilotinib is a drug that blocks the     effects of c-kit. Using this drug in combination with chemotherapy may improve ability of the     chemotherapy drugs to kill leukemia cells. This may then increase the chances of the leukemia     going into complete remission.   "
157498|NCT01222130|"     This study is designed to develop and evaluate a set of non-virologic diagnostic algorithms     to monitor HIV-exposed children of unknown infection status for treatment eligibility during     the first year of life. The results of this cross sectional study are expected to be used in     development of a series of non-virologic algorithms to determining treatment eligibility     among HIV-exposed children in settings where polymerase chain reaction (PCR) testing is not     available and to guide the judicious use of PCR testing among HIV-exposed children in     settings where PCR is available. These results will directly inform program implementation in     Zambia.   "
157499|NCT01222117|"     The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing     different delivery regimens in patients with peripheral arterial occlusion. The study     includes a blinded plasminogen activator treatment group and a blinded plasminogen activator     placebo group. The study will also assess safety and tolerability of Plasmin at 150 and 250     mg doses.   "
157500|NCT01222104|"     The purpose of this study is to collect data on the standard of care use of the St. Jude     Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in     diagnostic and/or interventional radiology patient populations.   "
157501|NCT01222091|"     This research study explores whether a beta-blocker can prevent a person from becoming more     sensitive to pain after administration of an opioid. Beta blockers inhibit the sympathetic     (fight or flight) response and are often used to treat angina and high blood pressure. In a     previous study in human volunteers, the investigators demonstrated an increased sensitivity     to pain after a 60-minute infusion of the opioid remifentanil. The goal of this study is to     identify a possible inhibitor of this phenomenon.   "
157502|NCT01222078|"     The purpose of this study to assess the safety and tolerability of re-dosing at 6 months with     otelixizumab (given as an 8-day series of intravenous infusions) in adult subjects with newly     diagnosed type 1 diabetes mellitus   "
157503|NCT01222065|"     The proposed human clinical studies have three main objectives:        1. To determine reproducibility of peripapillary birefringence maps and identify features          that measure the health of the RNFL.        2. To determine the normal variation in the birefringence maps with age.        3. To develop and test a classifier for glaucoma based on the birefringence maps using a          case-control clinical trial.      This study is a case-control study intended to optimize feature selection for a future     multi-center blinded study. The proposed clinical study does not measure conversion from     normal to glaucoma.   "
157504|NCT01222052|"     In low-risk node-negative breast cancer patients adjuvant chemotherapy should be spared. The     identification of this subgroup can be based either on clinical and pathological or on     tumour-biological criteria. Due to their high prognostic impact, the tumour-biological     invasion markers uPA/PAI-1 (urokinase-type plasminogen activator and its inhibitor PAI-1) are     potential candidates to effectively assess the risk of relapse in node-negative breast     cancer. This study is aimed to compare the risk assessment by the traditional     clinico-pathological factors and by tumour-biological factors. The second study question     refers to the comparison between an adjuvant combination treatment with FE100C*6 and a     sequential treatment with FE100C*3 and Docetaxel*3.   "
157505|NCT01222039|"     The main purpose of this trial is to assess the safety and feasibility of treatment with     two-dose infusion of allogeneic mesenchymal stem cells from adipose tissue expanded in vitro     in patients undergoing haematopoietic stem cell transplantation (HSCT, who have developed     chronic and extensive graft versus host disease (GVHD).      Mesenchymal stem cells (MSCs) express low levels of HLA class I molecules, and do not express     class II molecules neither CD40, CD80 and CD86, being unable to induce proliferation of     allogeneic lymphocytes. In addition, MSCs inhibit lymphocyte proliferation by inhibiting cell     division and maintaining these cells in a quiescent state. This supports the hypothesis that     MSCs are universal suppressors.   "
157506|NCT01222026|"     Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are treated     with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful surgical     treatment of pHPT.      Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or     osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD     than placebo treated patients.   "
157507|NCT01222013|"     The purpose of this study is to evaluate the efficacy, through molecular response and     event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM     like Induction in children with ALL Ph+.   "
157521|NCT01221831|"     This is an open-label, multi-centre, comparative study in young, healthy, female volunteers     of reproductive age.      Primary objective:      - To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal     bleeding patterns (cycle control), in comparison with a combined oral contraceptive     containing estradiol valerate and dienogest      Secondary objectives:        -  To investigate ovulation inhibition        -  To investigate the effect on SHBG        -  To assess pregnancy rate        -  To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight        -  To investigate return of menstruation after treatment        -  To evaluate general safety and acceptability   "
157508|NCT01222000|"     Lamellar ichthyosis (IL) is a rare autosomal recessive genodermatosis with a defect of     keratinization of the skin which results in a severe generalized cutaneous xerosis with dark     brown big scales, an ectropion, an eclabion, an alopecia and a palmo-plantar keratodermia.     They are due to mutations of the gene TGM1 coding for the transglutaminase keratinocyte 1     (TG1) in 1/3 of the cases. Other genes were recently identified, ABCA12 coding for the     triphosphate-binding adenosine cassette A12 and FLJ39501 which codes for a protein of the     cytochrome p450 ( CYP4F2).      No etiological treatment is available. Symptomatic treatment consists on twice application of     emollients and keratolytic ointments which decrease the dryness of the skin and reduce     scales. Oral isotretinoin is usually partially effective but is only suspensive and has     numerous side effects.      Recent studies showed that the epigallocatechin-3-gallate (POLYPHENON E®), extracted from     green tea increases the differentiation of the normal human keratinocytes, as showedb by the     increase of the involucrine, TG1 and caspase-14 genes expression.      The main objective of this pilot study is to estimate the action and the tolerance of a daily     application of topical Polyphénon E 10% ® to improve the desquamation and the cutaneous     roughness of patients with lamellar ichthyosis, after 4 weeks of treatment.      The secondary objectives        -  To estimate the duration of remission obtained after the treatment        -  To estimate the action of cutaneous Veregen® to improve the palmar and plantar          involvement.        -  To estimate the action of cutaneous Veregen on the pruritus        -  And to estimate the global level of acceptability by the patient of the Veregen 10 %   "
157509|NCT01221987|"     The current study will elucidate the human papillomavirus type distribution in a population     of women diagnosed with cervical high grade pre-cancerous lesions and invasive cervical     cancer in Sri Lanka.   "
157510|NCT01221974|"     The purpose of this study is to gather safety data related to the use of Essure®     micro-inserts in women with hydrosalpinx prior to in vitro fertilization and during pregnancy     and to collect data with regard to implantation rates, clinical pregnancy rates, and     pregnancy outcomes.   "
157551|NCT01221441|"     The purpose of this study is to see if we can safely regenerate cartilage without invasive     surgery using a biologic product called TissueGene-C.   "
157552|NCT01221428|"     The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of     treatment for ulcerative colitis is safe and effective.   "
168448|NCT00033098|"     The purpose of this study is to examine the safety of two consecutive days of metyrapone     (MRP) in subjects who may use cocaine concurrently.   "
157511|NCT01221961|"     This is a study designed to compare the agreement of hemoglobin (Hb) measurements, documented     at specific time points (the time a blood sample was obtained by the standard clinical care     after physician/nurse orders it and, during that same time, the Hb value recorded by the     Masimo Radical-7 monitor); recorded several times throughout patient's major spine surgery     procedure (depending on how many times the physician/nurse orders the Hb value to be tested),     between the standard clinical practice {intermittent measure of Hb [Cedar Sinai Medical     Center (CSMC) Lab and outside lab) and Masimo radical-7 device (continuous, non-invasive Hb     level measurements)*.   "
157512|NCT01221948|"     The purpose of this study is to document patient outcomes, including effectiveness, safety,     and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS)     Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment     of moderate to severe idiopathic Parkinson's Disease (PD).   "
157513|NCT01221935|"     The goal of this observational study is to learn about how Pristiq is currently being used in     general practice and how psychiatrists and primary care physicians currently perceive Pristiq     in terms of efficacy, tolerability, and adherence compared to other treatments for major     depressive disorder (MDD).   "
157514|NCT01221922|"     The purpose of this study is to evaluate the RevLite Q-Switched Neodymium:     Yttrium-Aluminum-Garnet (Nd:YAG) Laser in the treatment of acne scars in darker skin types     (Fitzpatrick Skin Types III, IV, V and VI).   "
157515|NCT01221909|"     Single dose tranexamic acid (TA) before dacryocystorhinostomy (DCR) operation: a prospective,     double blind, placebo controlled study.      The study hypothesis: TA in DCR might reduce the intraoperative and postoperative bleeding in     DCR surgery, and might reduce the duration of the surgery.   "
157516|NCT01221896|"     The purpose of the study is to determine a possible input of C11-Choline PET/CT in     identification and localization of a parathyroid adenoma (PTA).      Preoperative localization of a PTA has been previously documented in multiple series, and is     usually based on scintigraphy and on US.      Currently, the conventional technique for localization of a PTA is a dual-isotope scan with     Tc99m-MIBI and Tc99m pertechnetate. This study is acquired over at least 3 hours, includes     two i.v. injections and the patient has to stay 15-30 min per acquisition under the camera.      In addition, there is no anatomical imaging and further correlation with US is usually     recommended.      In contrast, PET/CT study with C11-Choline takes as long as 10 min., includes one injection,     and provides data of higher resolution of functional (PET) and anatomical imaging (CT).      Furthermore, dosimetric data shows that the total effective dose from Tc99mMIBI and Tc99m     pertechnetate injection is (without CT): 0.5957 rem; and from C11-Choline injection and CT of     a chest is: 0.3128 - 0.8628rem.   "
157517|NCT01221883|"     PTSD is a pervasive and frequent disorder. Early psychological treatment - but not     pharmacology - effectively prevent PTSD.      Current pharmacological studies did not include treatment given immediately after trauma     exposure.      However, a recent study of opiates suggests that their early administration may reduce the     likelihood of developing PTSD - possibly by mitigating early post-traumatic distress (UCR) -     within an adequate window of time.      Benzodiazepines are often used to reduce anxiety and agitation during stressful situations -     including traumatic event.      These compounds may increase the likelihood of developing PTSD when administered few days     after the traumatic event - but their effect as an immediate intervention has not been     studied - despite their frequent and uninformed use at this stage.      This work will evaluate the effect of diazepam - a BZ compound - on PTSD symptom trajectory     following traumatic event in a randomized controlled design.      Following the studies of opiates it is hoped that diazepam, administered within hours of the     traumatic event, and before the first night sleep (a memory consolidating condition) will     reduce the likelihood of developing PTSD. However, an adverse effect cannot be excluded, and     thus the investigators posit a bidirectional hypothesis.      The importance of this work is that it will provide the necessary evidence to sanction a     frequently practiced use of benzodiazepines.   "
157518|NCT01221870|"     The intravenously administered taxane, paclitaxel, is one of the most commonly employed     agents for the treatment of both localized and advanced breast cancer.      Tesetaxel is an orally administered taxane that is in development as first- and second-line     treatment for patients with advanced cancers. This study is being undertaken to determine the     efficacy and safety of tesetaxel administered as first-line therapy to patients with     metastatic breast cancer.   "
157526|NCT01221766|"     This research study will help us learn more about how chronic graft-versus-host disease     affects the skin, hair and nails. We are interested in knowing if hair and nail problems     predict worse disease. This information may help us treat patients like you in the future.   "
157527|NCT01221753|"     In this research study, the investigators are studying whether a reduced dose of radiation     when given with standard doses of chemotherapy can reduce side effects without compromising     control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck     is initial chemotherapy followed by radiation and chemotherapy together. This treatment is     effective but has many immediate and long-term side effects. People who have squamous cell     carcinoma of the head and neck (SSCHN) that is related to an infection by the human     papillomavirus (HPV) have been shown to have a high response to this treatment along with a     high cure rate. The investigators think that by reducing the intensity of this treatment,     they may be able to reduce immediate and long-term side effects which may lead to long term     improvements in quality of life and function.   "
157528|NCT01221740|"     1. To show that patients with greater pain sensitivity will show greater improvement in          their symptoms (self-reported pain intensity, mood, sleep, and quality of life) than          those with lower pain sensitivity, based on QST, after taking milnacipran.        2. To compare outcome differences (pain intensity, mood, activity interference, sleep, and          side effects) with those patients who are either taking or not taking opioids for their          pain 10 weeks after being prescribed milnacipran.        3. To show that patients who are older, male, with more medical comorbidities, greater          disability, and longer pain duration will report less improvement (pain, mood, sleep,          health-related quality of life) and treatment satisfaction while taking milnacipran          compared with others without such characteristics.   "
157529|NCT01221727|"     This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with     osteoporosis.   "
157531|NCT01221701|"     This study develops and contrasts In-Home Cognitive Behavioral Therapy (IH-CBT), an adapted     evidence-based treatment for depressed mothers participating in home visitation, with typical     home visitation in which treatment may be obtained in the community. Mothers will be     identified using a two step process consisting of administration of a screen and subsequent     diagnosis of Major Depressive Disorder. The will then be randomized into the treatment and     control conditions. A comprehensive assessment of depression and related areas of functioning     will be administered at pre-treatment, post-treatment, and 3 month follow-up. It is     hypothesized that IH-CBT will lead to broad and durable gains in mood and social support     relative to those in typical home visitation.   "
157532|NCT01221688|"     GANEA 2 is a new trial based on patient treated for a large breast tumor with proven axillary     involved nodes. Patients enrolled in this trial will have first an axillary sonography with     fine needle punction in case of suspected nodes before NAC. This primary evaluation allow to     determine two groups of patients : group 1 : patients with proven involved axillary nodes and     group 2, patients without proven axillary involved nodes. Patients of group 1, the study     group, will undergo SLNB and complete level I-II axillary lymphadenectomy. Patients of group     2 will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of     detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last     group will be followed 5 years in order to evaluate the risk of axillary relapse without     lymphadenectomy.   "
157533|NCT01221675|"     Lung cancer is currently the leading cause of cancer death in both men and women in Europe,     with an estimated 250000 new cases diagnosed in 2005. The continued poor outcome of patients     indicates that the current recommended regimens are falling short. In addition, many of the     commonly used chemotherapy agents are associated with severe nonhematologic toxicities that     are often cumulative and nonreversible and impair quality of life in this essentially     palliative setting. Therefore, agents with novel mechanisms of action and superior safety     profiles need to be investigated. More than 50% of lung cancer shows carcinoembryonic antigen     (CEA) expression and anti-CEA radioimmunotherapy (RAIT) could be used. The investigators     group showed that pretargeted RAIT (PRAIT) using bispecific antibody (bsMAb) can deliver a     higher radiation dose to a tumor than a directly radiolabeled anti-CEA antibody, and shows     improved anti-tumor efficacy. This clinical trial is designed to assess PRAIT using an     entirely new recombinant anti-CEA bsMAb and a 177Lu-labeled peptide for the treatment of     CEA-expressing small cell lung cancers (SCLC) or CEA-expressing Non Small Cell Lung Carcinoma     (NSCLC)   "
157534|NCT01221662|"     Brain hypoperfusion patients may cause vascular dementia results from their hypoperfusion     state except that is a risk factor for stroke. The most common clinical symptom of     hypoperfusion syndrome is dizziness.Siwu tang is made of Angelica sinensis (Oliv.) Diels     (當歸), Rehmannia glutinosa (Gaertn) Libosch (熟地黃), Paeonia lactiflora Pall (白芍), Ligusticum     chuanxiong Hort (川芎), and that was used to treat patients with blood deficiency for several     centuries. the purpose of the present study was to investigate the complementary effect of     siwu tang on brain hypoperfusion syndrome patients   "
157535|NCT01221649|"     The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of     measuring the intrathoracic impedance on a daily basis and transmission of impedance trend     data via the Home Monitoring technology. In future, this will allow for automatic early     detection of imminent decompensation at a presymptomatic stage and immediate initialization     of clinical meaningful therapeutic interventions preventing heart failure (HF) related     hospitalizations. The aim of this investigation is to record long-term impedance trends in     heart failure patients with and without heart failure related events (hospitalizations due to     acute decompensation) in order to develop algorithms for device-based early detection and     warning of HF deterioration accompanied by pulmonary congestion.   "
157536|NCT01221636|"     The purpose of this study is to determine whether the blood levels of abatacept drug product     manufactured using High Metals and using Low Metals are comparable in healthy subjects.   "
157642|NCT01220258|"     One objective of this study is to determine the levels of markers of inflammation on the     eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy     volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the     effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and     conjunctivae and on signs and symptoms of blepharoconjunctivitis.   "
157537|NCT01221623|"     This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety and     efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 300 (200 AA4500     and 100 placebo) men will be randomized. Subjects will be screened for study eligibility     within 21 days before the initial injection of study drug in the first treatment cycle.      Before dosing, subjects will be stratified by degree of penile curvature (ie, 30º to 60º or     61º to 90º) and then randomized into two treatment groups to receive in a 2:1 ratio either     AA4500 0.58 mg or placebo.      In this study, qualified subjects may receive up to four treatment cycles; each cycle will be     separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will     receive two injections of study drug with at least 24 hours but not more than 72 hours     between injections. After the final injection of each treatment cycle, the investigator or     qualified designee will model the penile plaque in an attempt to stretch or elongate the     plaque. If the subject's penile curvature is reduced to < 15 degrees after the first, second,     or third cycle of injections or if the investigator determines further treatment is not     clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles     will not be administered.      Following the maximum of four treatment cycles, each subject will be followed for additional     safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365     (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive     open-label AA4500 treatment after completing this study as part of another protocol.   "
157538|NCT01221610|"     A prospective, multi-centre, randomized controlled, First in Man study to assess the safety     and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an     uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal     arteries.   "
157562|NCT01221298|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and     antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072     and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus     (HCV) infection.   "
157539|NCT01221597|"     This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety and     efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 400 (267 AA4500     and 133 placebo) men will be randomized. Subjects will be screened for study eligibility     within 21 days before the initial injection of study drug in the first treatment cycle.      Before dosing, subjects will be stratified by degree of penile curvature deformity (ie, 30º     to 60º or 61º to 90º) and then randomized into two treatment groups to receive in a 2:1 ratio     either AA4500 0.58 mg or placebo.      In this study, qualified subjects may receive up to four treatment cycles; each cycle will be     separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will     receive two injections of study drug with at least 24 hours but not more than 72 hours     between injections. After the final injection of each treatment cycle, the investigator or     qualified designee will model the penile plaque in an attempt to stretch or elongate the     plaque. If the subject's penile curvature is reduced to <15 degrees after the first, second,     or third cycle of injections or if further treatment is not clinically indicated, subsequent     treatment cycles will not be administered.      Following the maximum of four treatment cycles, each subject will be followed for additional     safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365     (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive     open-label AA4500 treatment after completing this study as part of another protocol.   "
157540|NCT01221584|"     The purpose of the study is to establish the proportion of patients on lipid-lowering     pharmacological treatment reaching the LDL-C goals according to the All-Russian Scientific     Cardiology Society guidelines/ the 4th Joint European Task Force guidelines.   "
157541|NCT01221571|"     The aim of this study is to determine the safety, tolerability, pharmacokinetics and activity     of single cycles of AFM13 in patients with CD30 positive refractory and/or relapsed Hodgkin     lymphoma.   "
157542|NCT01221558|"     The hypothesis was that an increase in serum lycopene levels following supplementation with     capsules containing natural lycopene rich tomato extract would reduce oxidative stress and     improve endothelial function in healthy men with low intake of fruits and vegetables. A     randomized double-blind, placebo-controlled study was designed to assess the changes in serum     lycopene levels, oxidative stress and endothelial function in response to an 8-week treatment     with lycopene supplementation.   "
157543|NCT01221545|"     The purpose of this study is to investigate safety and tolerability after high Single     Ascending Oral Doses of AZD1656.   "
157544|NCT01221532|"     The investigators will randomize 700 non-psychiatric, non-obstetric, non-surgical patients     aged 55 years and older at San Francisco General Hospital (SFGH) to usual care (ten days of     prescription medication, discharge summary sent to primary care provider (PCP), and     outpatient appt made for patient, and patient's nurse reviews discharge plan,) or usual care     plus a peridischarge intervention (a visit with specialized in-hospital discharge nurse,     development of personalized discharge plan, two phone calls from a nurse     practitioner(NP)/physician assistant (PA) after discharge and availability of additional     calls back from NP/PA, upon patient request, to help answer questions and assist patient's     transition to outpatient care, and communication with primary care/subspecialty providers).     The usual care and usual care plus intervention groups will be assessed for differences in     mortality and rates of rehospitalization and emergency department use 30, 90 and 180 days     following discharge from the hospital.      The discharge process from the hospital to home is frequently marked by poor quality and high     risk of adverse events and readmissions. It has been hypothesized that better coordinated     care, personalized patient education, and follow-up calls to identify potential sources of     adverse events, such as medical complications and medication errors can reduce     rehospitalization and emergency room visits following discharge from the hospital. Although     these interventions have been shown to reduce combined hospital readmissions and emergency     department visits in English-speaking patients, none has focused on elderly patients in a     diverse urban public hospital setting that includes non-English-speakers, who might benefit     more than other populations from enhanced services during and after discharge from the     hospital. Further, these labor-intensive interventions are costly to implement, and it is     unknown whether opportunity cost of providing additional services in a limited-resource     environment such as San Francisco General Hospital (SFGH) outweighs the unknown clinical     benefits.   "
157545|NCT01221519|"     The purpose of this study is to assess the relative bioavailability by measuring the extent     and rate of absorption of different tablet formulations of AZD1656 in T2DM patients.   "
157546|NCT01221506|"     All patients who participate in this study will receive pazopanib. Pazopanib is an oral drug     (pill) that has been approved by the U.S. Food and Drug Administration (FDA) for the     treatment of advanced kidney cancer. In this study, the investigators plan to learn more     about the way this drug works by using special scans (MRIs and Ultrasounds) to help evaluate     how this drug is working on this disease. Approximately 20 people with advanced kidney cancer     will be enrolled on this study.   "
157547|NCT01221493|"     To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral     lung lesions   "
157548|NCT01221480|"     The aim of this observational study is to utilise the established record linkage data     available in Tayside to investigate hospital admissions, exacerbations and mortality in COPD.   "
157549|NCT01221467|"     Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring     life-long insulin therapy. Children and adolescents with T1D need regular insulin injections     or the continuous insulin delivery using an insulin pump in order to keep blood glucose     levels normal. The investigators know that keeping blood sugars in the normal range will help     prevent long-term diabetes-related complications involving the eyes, kidneys and heart.     However, achieving treatment goals can be very difficult as the tighter the investigators try     to control blood glucose levels, the greater the risk to develop symptoms and signs of low     glucose levels (hypoglycaemia). This is a particular problem at night and one solution is to     develop a system whereby the amount of insulin injected is controlled by a computer and is     very closely matched to the blood sugar levels on a continuous basis. This can be achieved by     what is known as a closed-loop system where a small glucose sensor placed under the skin     communicates with a computer containing an algorithm that drives an insulin pump. The     investigators have been testing such a system in Cambridge over the last three years in     children and have found that this system is effective at preventing nocturnal hypoglycaemia.     The next stage of this research is to test the system for a longer period of time at home. In     the present study the investigators are planning to study 16 adolescents aged 12-18 years on     insulin pump therapy. During 21 nights glucose will be controlled by the computer and during     the other 21 nights the subjects will make their own adjustments to the insulin therapy. The     investigators will then analyze the data to determine the effect of the computer algorithm in     keeping glucose levels between 3.9 and 8 mmol/L (normal levels) and reducing the time they     spent with glucose below 3.9 mmol/L (hypoglycaemia). Subjects' response to the use of the     system in terms of life-style change, daily diabetes management and fear of hypoglycaemia     will be assessed. The investigators will also test for longer term glucose control by     measuring glycated haemoglobin and other blood parameters.   "
157550|NCT01221454|"     The purpose of this study is to evaluate the therapeutic efficacy of allogenic bone marrow     stem cells (BMSCs) transplantation in patients with liver failure caused by hepatitis B     infection. The evaluation of the efficacy includes the level of serum alanine     aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin     time (PT), albumin (ALB), prealbumin(PA), liver histological improvement before and 1 week to     1 year after transplantation. Child-Pugh scores, MELD scores and clinical symptoms were also     observed simultaneously.   "
157553|NCT01221415|"     The primary objective of this study is to compare ultrasound versus nerve stimulator     techniques for nerve localization when performing peripheral nerve blocks. Specifically the     investigators will be performing Popliteal, Femoral, and Interscalene nerve blocks. The     investigators will be looking for differences in 1) time taken to locate the target nerve and     inject local anesthetic 2) time from injection of local anesthetic to adequate surgical     anesthesia 3) effectiveness of block 4) incidence of vascular puncture 5) incidence of     adverse events 6) patient satisfaction.   "
157554|NCT01221402|"     Intermediate saphenous vein graft (SVG) lesions are common, have high rates of progression to     severe lesions or occlusion, and are associated with high incidence of adverse clinical     outcomes.      The ALPINE-SVG trial is a randomized-controlled trial of extended-release niacin vs. placebo     in patients with intermediate saphenous vein graft lesions. The main hypothesis of the study     is that compared to placebo, niacin administration will result in reduction in percent     atheroma volume at 12-month follow-up angiography.   "
157555|NCT01221389|"     Information on the management of casualties from the ongoing conflicts in Afghanistan and     Iraq has brought in to question the traditional approach to blood transfusion in hemorrhaging     patients. Present recommendations for when to transfuse plasma products is when coagulation     tests become abnormal. The proposed trial will investigate whether the more aggressive plasma     transfusion strategies as advocated from researchers based on the Central Asian conflicts is     valid. Since a study to determine the full impact of an altered plasma transfusion practice     would require thousands of patients, a feasibility trial is appropriate and is being     proposed. The hypotheses are thus:      Primary Hypothesis- A multicentre trial that investigates the earlier use of plasma in     patients with hemorrhagic shock going for emergency surgery will be feasible.      Secondary Hypotheses- The early use of a universal donor blood plasma (AB+ plasma) in     patients with shock due to blood loss (i.e. hemorrhagic) going for emergency surgery will     reduce overall exposure to the total number of blood donor products (so-called allogeneic     blood exposure). A reduction in allogeneic blood exposure would then reduce the total number     of blood transfusion-related complications. The early use of this plasma product is safe and     will not increase the incidence of blood clotting or other transfusion-related complications.   "
157556|NCT01221376|"     The purpose of this study is to evaluate the hematological, cytogenetic and molecular     response to continuous-use of Imatinib in children with CML Ph+.   "
157557|NCT01221363|"     Recent studies have suggested that prolonged daily sitting time may in itself have a negative     effect on health, even in people who engage in daily physical activity.      The aim of the present study is to explore whether individually tailored lifestyle     counselling aimed at reducing TV-viewing and other sedentary activities during leisure time     and at work, can reduce sitting time and waist circumference, weight and blood pressure; and     improve serum lipid levels. From a population-based health survey, 150 adult men and women     with more than 3.5 hours of daily leisure time sitting time are recruited and randomly     assigned to 1) an intervention group or 2) a control group. The intervention group will     participate in 4 individually tailored lifestyle intervention sessions focussing on reduction     of daily sitting time. The control group will receive no intervention.   "
157558|NCT01221350|"     The aim of the study is to use the antioxidant and antiinflammatory effects of lipoic acid to     improve the quality of life of patients with asthma.      The investigators will administrate 600 mg lipoic acid orally on a daily basis during two     months concurrent with the patient anti-asthmatic therapy and evaluate the effects on     resulting pulmonary function, inflammatory and oxidative stress biomarkers and health-related     quality of life previous to the initial of the treatment and at 60 days of the supplementary     therapy.   "
157592|NCT01220908|"     The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction     Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a     less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as     an alternative to lung volume reduction surgery, potentially achieving the desired reduction     in lung volume limiting the risks associated with major surgery, such as illness or death.     This device is deployed through a bronchoscope and requires no incision.   "
158035|NCT01215123|"     This observational study will assess the median time of treatment duration and the safety of     Avastin (bevacizumab) as first line treatment in patients with metastatic breast cancer. Data     will be collected for approximately 24 months.   "
157559|NCT01221337|"     The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal     circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy     during a haemodialysis session. In the cases of multiple coagulation defects having high     haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended     to reduce the heparin doses or to do heparin free haemodialysis. Several strategies of low     heparin or heparin free haemodialysis have been proposed till now, without a real success.     The heparin coated polyacrylonitrile haemodialyser (EVODIAL) has been reported to have 90 %     successful heparin-free haemodialysis sessions. On the other hand, the vitamin E coated     polysulphone (VIE) has also been reported to have an anti oxidative and anti-thrombotic     properties and a capacity to improve the haemorrheological factors of human blood, hence     having a promising future to perform a successful haemodialysis session with less or without     heparin. This randomised, multi-centric, cross-over and open study has been designed to     compare non inferiority of the haemodialyzer VIE 2,1 versus EVODIAL2,2 with a risk alfa of 5%     and an absolute accepted difference of 12 %.   "
157560|NCT01221324|"     Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive     protein (CRP) and white blood cell counts (WBC) in the postoperative course. The aim of this     study was to evaluate the diagnostic accuracy of CRP and WBC for postoperative inflammatory     complications after open resection of colorectal cancer.   "
157561|NCT01221311|"     The current standard of care for benign bile duct strictures involves placement of multiple     plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch     it open. This approach necessitates multiple procedures which may extend over one year before     the stricture is adequately dilated. The investigators propose a study comparing the standard     approach of plastic stenting with the use of newer, fully coated metallic stents which are     self-expandable, thereby permitting successful dilation of benign bile duct strictures with     fewer procedures.   "
157564|NCT01221272|"     This study enrolled participants with documented exercise-induced myocardial ischemia in     order to evaluate whether ranolazine, when taken prior to exercise, can improve blood flow to     the heart (myocardial perfusion), as assessed by exercise-induced myocardial perfusion defect     size (PDS) and total perfusion deficit (TPD), using gated single photon emission computed     tomography (SPECT) myocardial perfusion imaging (MPI).      This was a 2-period crossover study. The last dose of each period must have been taken 3-4     hours prior to conduct of the exercise SPECT MPI. After the research exercise SPECT MPI was     performed at the end of Period 1, participants discontinued the treatment they were     randomized to for that period and began the other treatment in Period 2.   "
157565|NCT01221259|"     This study is designed as a single ascending dose study in healthy subjects to evaluate     safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) in plasma and     Cerebrospinal (CSF) following single oral doses of E2212.   "
157566|NCT01221246|"     The purpose of this research study is to determine whether the investigational drug GM602, is     effective and safe in the treatment of ischemic stroke (strokes caused by a blood clot     blocking the flow of blood through one, or more of the blood vessels supplying the brain)     when administered up to 18 hours after symptoms begin.   "
157567|NCT01221233|"     Rehabilitative Ultrasound Imaging (US) is a procedure used to evaluate skeletal muscle size     and function to inform clinical practice. US has been shown to be a reliable and valid tool     for measuring changes in trunk muscle (i.e. abdominal and back muscle) size and activity     during sub-maximal contractions in younger populations. Younger adults with low back pain as     compared with healthy adults without pain demonstrate smaller back muscle size, lower back     muscle activity, and greater back muscle asymmetry (differences in right side compared with     left side).      No trials are published evaluating muscle adaptations using US in response to clinical     treatments for low back pain in the older adult population. Increased muscle size and     improved muscle symmetry have been reported in younger adults with low back pain who     participate in low back stabilization exercises. These exercises use voluntary contractions     of the back muscles with prolonged hold times and low loads. Neuromuscular Electrical     Stimulation (NMES) is a treatment modality that increases muscle activity when voluntary     activity is impaired and increases muscle size. Most studies assessing muscle size and     activity in response to NMES have been conducted in the knee muscles (i.e. the quadriceps),     while the impact of NMES on the back muscles remains relatively unexplored. Given the     potential to evaluate back muscle size and activity with US, this assessment tool may be used     to document muscle adaptations to a clinical intervention in older adults with low back pain.      The purpose of this study is to conduct a 6-week clinical trial to determine if NMES plus     lumbar stabilization exercises is superior to lumbar stabilization exercises for improving     back muscle size, activity, and side-to-side (i.e. right side versus left side) symmetry in     older adults with chronic low back pain (i.e. low back pain of greater than 3 months). Muscle     size, activity, and symmetry will be assessed using US before and after the treatments to     determine if the treatments positively impact muscle. Secondary clinical measures of success     will include improvements in physical, psychological, and social function pre- to     post-treatment.   "
157568|NCT01221220|"     There is a need for effective weight control methods for obese children. Environmental     strategies such as reducing the size of dishware and serving utensils, storing food out of     view and reducing food consumption while watching television may reduce food intake without     requiring conscious, cognitive self-control. The investigators propose to test these methods     when added to a current state-of-the-art behavioral program.   "
157569|NCT01221207|"     Aim 1. To compare the effectiveness of total contact casts (TCC), removable cast walkers     (RCW) and instant total contact casts (ITCC) to heal diabetic foot ulcers in a 20 week     randomized clinical trial of 225 patients in community care in three university medical     center diabetes clinics.      Aim 2. To compare the frequency of complications such as soft tissue and bone infections,     iatrogenic wounds, falls and fall related injuries, and amputations among patients treated     with TCC, ITCC and RCW to heal diabetic foot ulcers.      Aim 3. To compare patient compliance and level of activity among TCC, ITCC, RCW treatment     groups. Using computerized activity monitors which time-stamp each step, we will evaluate     both degree and magnitude of activity between groups.      Aim 4. To evaluate the cost of diabetic foot ulcer-related treatment and complications during     the course of therapy.   "
157570|NCT01221194|"     1. To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings,          PFC) in reducing the incidence of diabetic foot pathology among high-risk patients.        2. To evaluate perceived health-related quality of life as compared to guideline directed          usual care in patients who use the PFC stockings.   "
157571|NCT01221181|"     This is an open label, non-blinded, proof of concept efficacy and safety study of eculizumab     in patients with biopsy proven DDD or C3 nephropathy. The trial will consist of adult     patients with these diseases who have > 1 gram of proteinuria or a decreased glomerular     filtration rate (GFR), both predictors of a poor long-term outcome in many glomerular     diseases. They will be treated with eculizumab for one year. The goals will be to determine     whether treatment leads to an improvement in kidney function, defined by remissions of     proteinuria and improvements in estimated GFR (measured by serum creatinine), and to     improvement in histologic parameters, including percentage of non-affected glomeruli,     interstitial fibrosis, intensity of C3 staining of immunofluorescence, and amount of electron     dense deposits by electron microscopy.      All enrolled subjects will receive eculizumab treatment for one year. There will be 29 study     visits over 53 weeks. The goal is to determine whether this treatment will improve kidney     function, as evidenced by less protein in the urine and improved lab results.      An EXTENSION TREATMENT PHASE has been added. After completing the study, patients are     followed with labs every four weeks as per standard of care. If labs suggest a relapse, they     will be allowed to continue on therapy at the previous dosage until this drug receives FDA     approval for this indication. Treatment intervals and dosage are identical to the original     study.   "
157572|NCT01221168|"     The aims of the study are:        -  to identify genetic and molecular factors (rare mutations, polymorphisms) involved in          the natural history of prostate cancers and their response to treatment,        -  to evaluate and deduce their medical applications for screening and therapeutic          management of these tumors.   "
157573|NCT01221155|"     Manual treatment offers benefit to some patients suffering from back pain but little is known     about which of the many tissue layers are affected. This study will help identify which     tissues may be stimulated sufficiently to be a source for the clinical effects of treatment     and to prioritize future work to understand mechanisms of back pain and to improve care.      Current soft-tissue ultrasound elastography techniques, under static condition, will be     extended to quantify relative displacement and strains(active and passive)across the depth of     tissue strata that arise from small amplitude motions during continuous passive motion     clinical procedures and in weight bearing postures. Relative movement of the stratified     layers of the back, from treatment and task-generated perturbations, will enable the     elastography interrogation of the tissue.   "
157574|NCT01221142|"     In this pilot study the researchers will investigate efficacy of hypothermia in the early     stage of treatment patients with primary intracerebral hemorrhage.   "
157577|NCT01221103|"     The rationale for this study design is based on the fact that the maximum tolerated dose     (MTD) of single-agent ofatumumab and bendamustine have been previously determined. The choice     of the doses for the combination is based on the investigators unpublished clinical     experience, as well as inferred from extensive experimental data on the use of other     monoclonal antibodies in combination chemotherapy in lymphoma patients. The starting dose of     the 2 main component drugs is the MTD of each drug as single agent.   "
157578|NCT01221090|"     To evaluate the effectiveness of two different diabetes self-management approaches (Personal     Digital Assistant-based intervention & Chronic Disease Self-Management Program) to reduce     health disparities in minority, rural residents, and other underserved populations with type     2 diabetes in Central Texas. We hypothesise that: 1) Racial/ethnic minority patients with     T2DM will be found to experience disparities in diabetes self-management treatment protocols     and clinical outcomes, which persist even when controlling for age, gender, obesity, and     insurance status; 2) Patients with T2DM who reside in more rural areas will be found to     experience disparities in diabetes self-management treatment protocols and clinical outcomes     as compared to more urban counterparts, controlling for age, gender, race/ethnicity, obesity,     and insurance status; 3) The introduction of CSDMP and HIT protocols will improve     diabetes-related self management behaviors, reduce HBA1c values, and increase quality of life     in persons with T2DM as compared to controls. A combined intervention approach will result in     the greatest reductions; 4) Health improvements following the introduction of CDSMP, HIT or     CDSMP/HIT protocols in persons with T2DM compared to controls will be more marked in     racial/ethnic minority patients and those patients residing in rural areas; 5) The     introduction of self-management interventions will be cost-effective in reducing HbA1c values     over time, and associated health care utilization including overall reduction in ER and acute     care hospital admissions; 6) Although there is little prior research in this area to guide     specific hypotheses, we hypothesize that, overall, there will be no significant     cost-effective differential in CDSMP as compared to HIT approaches, although the     cost-effective ratio may be stronger in particular subpopulations. The combined approach will     have higher costs, but is also anticipated to have a higher cost-benefit ratio for minority     populations; 7) The majority of clinicians will be willing to let their patients enroll in     the study and will reinforce intervention protocols; and 8) These interventions can be     embedded into existing health care structures. At the end of the study, Scott and White will     institutionalize cost-effective treatment protocols.   "
157579|NCT01221077|"     A multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Erlotinib     (Tarceva®) in combination with OSI-906 in Patients with Advanced non-small cell lung cancer     (NSCLC) with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene who are     Chemonaive.   "
157580|NCT01221064|"     The aim of the study is to assess whether early drainage removal in patients with less than     150ml of lymph in postoperative day 1 can reduce total lymphorrhoea   "
157581|NCT01221051|"     The purpose with this study was to compare blood loss and women's experience of afterpains     during the third stage when handled with active or expectant management of the third stage of     labour.      Hypothesis 1. To detect a 5% difference (15% vs 10%) in blood loss >1000 mL between the two     groups with 80% power (α=0.05), at least 726 subjects were required in each group.      Hypothesis 2. Afterpains are more pronounced in active compared to expectant management     during the third stage of labour   "
157582|NCT01221038|"     Background:      Heat stroke is defined as a condition where the body temperature raises to dangerous level     that may cause harm to body tissues and lead to multi-system clinical and pathological     manifestations that might lead to death. Among heat stroke survivors a defect in     thermoregulation develops as a consequence. In the IDF, every soldier who had a heat stroke,     or is suspected to have had a heat stroke, must pass a heat intolerance test in the Unit of     Military Physiology, after a rest period of 4-6 from the incident, which is the approximate     period for thermoregulation to recuperate from the injury after a heat stroke. Until the heat     intolerance test, the soldier must not train to avoid a repeat incident of heat stroke. The     soldiers' ability to return to active duty is based on the results of the exam. The heat     tolerance test and its criteria have been developed in the Physiology Unit throughout years     of experience, and have been proved and adopted by several labs in Europe and in the United     States. The criteria generally include baseline temperature and heart rate, and are based     upon the physiological response of healthy men (soldiers) in the physical effort involved in     the test.In recent years there is a growing trend in the IDF to integrate female soldiers in     combat divisions. As a result, these females are exposed to physical efforts in various     climate conditions as a part of their training, or a part of their active duty missions in     the division. Therefore, the probability of an incidence of heat injuries increases among     these soldiers.Research results indicate differences in the efficiency of thermoregulation     mechanisms between men and women:      It has been found that in women the threshold for sweating and vasodilatation is higher than     in males. Additionally, although in women the mechanism for sweating is slower, and occurs at     a later period, it is found that the relative part of sweating that evaporates is higher, so     that women evaporate sweat more efficiently (to make up for the lower sweat quantities     compared to men). Reduced efficiency of the thermoregulation mechanisms in women is also     attributed to the differences in mass, body composition (fat and muscle mass), and physical     fitness between the genders. In addition, the physiological changes that occur during the     different phases of the menstrual cycle can affect core temperature at rest and     thermoregulation. Different reports in literature indicate a decreased thermoregulation     capacity in the luteal phase of the menstrual cycle compared to the follicular phase.     Apparently, thermoregulation capabilities in exercise are linked to progesterone blood     levels, which are influenced by contraceptive pills and with the phase of the menstrual     cycle.      There are two factors that can cause incorrect diagnosis of the level of heat tolerance in     females when the specific test is interpreted based on set criteria for men. These criteria     are:        1. The physiological differences between men and women        2. The differences in women based on menstrual cycle and using contraceptive pills.      Thus, there is a need to characterize and establish the normal values in a heat tolerance     test for young females compared to males, and also to correspond to current menstrual cycle     phase and use of contraceptive pills.      Methods:      on the first day of the research, the participants will undergo anthropometric examinations     (measuring height, weight, BMI, fat content, maximum oxygen consumption). In addition, the     participants will undergo a heat tolerance test protocol. The heat tolerance test will be     conducted twice in every participant - once in the follicular phase of the menstrual cycle,     and a second time in the luteal phase of the cycle. During the protocol, the following     information will be collected from each participant: heart rate, core temperature, skin     temperature in three locations (chest, arm, and leg), oxygen consumption and liquid balance.      The results of the examination will be compared to results of male participants who have     previously undergone the heat tolerance test in the Unit of Military Physiology.      Contribution to IDF:      the research will allow administrating heat tolerance tests accurately and reliably to female     soldiers that have been affected by heat injuries or are suspected to be heat intolerant.   "
157593|NCT01220895|"     The purpose of this study is to evaluate the potential clinical benefit of pre-emptive     cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic     hematopoietic stem cell transplantation (HSCT) for reducing recurrent CMV reactivation.   "
157619|NCT01220557|"     This study is a randomized prospective trial with 6-month follow up. A non-inferiority     hypothesis is tested. A new developed treatment and education programme for type 1 diabetic     patients (PRIMAS) will be tested compared to an established treatment and education programme     (German DTTP). Primary outcome variable is glycemic control at 6-month follow up. Secondary     outcome variables are: diabetes knowledge, diabetes related distress, depressive symptoms,     diabetes self-efficacy, self-care behavior, attitudes towards diabetes and insulin treatment,     hypoglycemia awareness.   "
157583|NCT01221025|"     This prospective, double blind, placebo-controlled, parallel group study will be conducted in     three study centers in Guangzhou, China. Patients aged older than 65 (ASA I-III) undergoing     primary elective abdominal surgery with general anesthesia will be involved in this study.     According to previous studies and our pilot trial, the sample size was estimated to be 900     subjects (each center recruiting 300 patients). All eligible patients will be randomly     assigned to one of two groups: study group receiving parecoxib and control group receiving     normal saline. All patients will be managed with by a standard clinical anesthesia protocol     with a sevoflurane-based general anesthesia with continuous intravenous remifentanil,     followed by a postoperative PCA with morphine. The emergence delirium will be evaluated by     two persons blinding to medication and grouping using Riker sedation-agitation scale     immediately since tracheal extubation and at specific time points until patients being     discharged from PACU. Pain intensity assessments and pain relief assessments will also be     conducted by the patients at given time points in 2 days postoperatively. The     morphine-sparing effect, tolerability and safety of parecoxib will be investigated as well.   "
157584|NCT01221012|"     Current protective clothing of any kind, especially the nuclear-biological-chemical (NBC)     protective garments, amplify thermal stress because of the inherent properties of the     clothing material. High insulation coefficient and low water vapor permeability of the     protective cloth limit the ability of sweat to readily evaporate, which consequently result     with a significant elevation of body temperature and with excessive body fluid loss (because     of inefficient sweating) that might result with significant dehydration.      Combat soldiers require to perform intense physical activities under hostile environmental     conditions, including in contaminated areas that need the use of protective garments. The     ability to fulfill a mission derives from the soldier's professionalism and from his     physiological limits. It is well established that wearing protective garments affect     tolerance time (TT) and performance.      To operate in contaminated areas suitable protective garments should be worn. The inherent     characteristics of the current protective garments limit, however, the effective working     periods with such an ensemble, which is further aggravated in hot climate. Thus, in an     attempt to increase TT and enhance work effectiveness, improved protective garments, which     result with a lessened heat-stress, are under different stages of development.      The relative influence of air permeability properties, garment weight and garment     construction on heat stress and physiological strain will be investigated.      The results will be quantified in terms of body temperatures, heart rate, fluid balance,     subjective sensation and the maximum wear time (if necessary extrapolated).   "
157647|NCT01220193|"     The purpose of this study is to evaluate RTVue measurement of the cornea in various ocular     conditions to include normal, pathology, post refractive surgery and cataract.   "
157648|NCT01220180|"     This study collects post-marketing safety and efficacy surveillance data in real world     clinical use of pregabalin for its approved indications in Korea.   "
157585|NCT01220999|"     This is a clinical trial of CS-1008 which is a humanized monoclonal antibody.      This trial explores where CS-1008 distributes in the body, and the activity of CS-1008 in     patients with metastatic colorectal cancer. The purpose of this study is to give patients     with metastatic colorectal cancer a series of different CS-1008 antibody doses in order to:        -  Study how the dose of CS-1008 effects where the CS-1008 distributes in the body          (biodistribution), how long it circulates in blood (pharmacokinetics) and how much          attaches to tumour (tumour uptake). These issues are studied after the initial infusion          of 111In-CS-1008 (CS-1008 tagged with a small amount of radioactive Indium - also called          Indium-111 or 111In), and also during and after a cycle of weekly infusions of CS-1008          antibody.        -  Study changes in the function (metabolism) of tumour cells following CS-1008          administration.        -  Assess whether repeat doses of CS-1008 cause shrinkage of the tumour.        -  Study whether experimental treatment with CS-1008 changes chemicals in the blood that          may indicate tumour cell death (serum apoptosis biomarkers) and/or tumour response to          treatment (serum tumour biomarkers (CEA - carcinoembryonic antigen)).   "
157586|NCT01220986|"     The aim of this study is to characterize Kupffer cell activity and activation of the innate     immune response in the early phase of liver regeneration after right hepatectomy. The     investigators hypothesise that liver regeneration after right hepatectomy in humans is     associated with Kupffer cell activation and initiation of the innate immune response and that     impaired liver regeneration, liver failure and sepsis following liver resection are     associated with Kupffer cell dysfunction and an impaired innate immune response. The     objectives for this study are to characterise Kupffer cell activity and the innate immune     response in human liver before and after right hepatectomy.   "
157587|NCT01220973|"     RATIONALE: Atorvastatin calcium and celecoxib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Giving atorvastatin calcium together with     celecoxib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving atorvastatin calcium together with     celecoxib works in treating patients with rising PSA levels after local therapy for prostate     cancer.   "
157588|NCT01220960|"     As studies continue to debate the effects of quality of life on survival, increased attention     is being focused on investigating complementary alternative therapies to boost overall total     health in cancer patients . Art therapy is an interesting growing field, which has shown     promise to positively influence quality of life in the pediatric and adult oncology     population alike. As there is a paucity of well controlled complete studies in this field,     the investigators propose to study the impact of art therapy sessions in women with breast     cancer with quantitative and qualitative analysis of emotional health and physical symptoms.      The results of the investigators study will have widespread applicability to oncology     programs that wish to offer/implement such sessions to their palliative and non-palliative     outpatients in an effort to address the important concept of whole person care.   "
157589|NCT01220947|"     This randomized, open-label, active-controlled, parallel-group study will evaluate the     sustained virological response of danoprevir boosted with low dose ritonavir in combination     with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in     treatment-naive patients with chronic Hepatitis C.   "
157590|NCT01220934|"     This observational, multicenter study will assess the efficacy and safety of Herceptin     (trastuzumab) in routine clinical practice in patients with HER2-positive advanced     adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be     collected for approximately 12 months.   "
157591|NCT01220921|"     The creation of a multi-center cooperative research group encompassing academic and     community-based spinal practices . . .   "
173319|NCT00110695|"     The purpose of this study is to learn how breast cancer tumors respond to a drug called     Abraxane followed by a combination of 3 chemotherapy drugs commonly used for breast cancer.   "
157594|NCT01220882|"     This study is being done for two reasons: 1) to evaluate growth problems in the hip in     patients with Slipped Capital Femoral Epiphysis (SCFE) as they continue to grow into adults,     and 2) to help doctors determine which patients are at risk for developing a SCFE on their     opposite hip. Studies show that up to 60% of patients with a SCFE will go on to develop a     SCFE on their other side. Being able to better determine which patients are at risk for     developing a SCFE on the other side will help physicians better monitor patients with a     history of a SCFE and perhaps treat them before they develop a SCFE on the opposite side. By     studying the growth centers seen on X-rays of your child's legs and elbow, the investigators     may be able to better predict which children with a SCFE are at risk for developing a SCFE on     their opposite hip and potential growth problems as they continue to grow.   "
157595|NCT01220869|"     A phase III trial investigating the efficacy and safety of degarelix one-month depot in     Taiwanese patients with prostate cancer.   "
157596|NCT01220856|"     Inhibition of CXCL8 activity might represent a relevant therapeutic target to prevent injury     occurring after pancreatic islet transplantation. Reparixin is a novel and specific inhibitor     of CXCL8. This study is designed to explore the efficacy of reparixin in preventing graft     dysfunction after islet transplantation in type 1 diabetes patients (T1D).   "
157597|NCT01220843|"     The purpose of this study is to evaluate in Chronic Kidney Disease (CKD) patients not on     dialysis and who have an Fibroblast growth factor 23 (FGF23) serum levels elevated, the     effect of non calcic phosphate binder: sevelamer carbonate. This treatment could lead to a     diminution of FGF23 serum levels due to the diminution of intestinal absorption of dietary     phosphate. In addition, the investigators will describe the impact of the FGF23 level     monitoring on the main phosphocalcium metabolism markers as phosphatemia, intact parathyroid     hormone (iPTH), serum calcitriol and phosphaturia.   "
157598|NCT01220830|"     The purpose of the study is to evaluate the efficacy of RFQMR therapy in remyelination in     cases of Multiple sclerosis.      The evaluation will be done based on MRI findings, by clinical/ neurological examination and     by assessment of quality of life before and after completion of therapy.   "
157599|NCT01220817|"     When given to men with recurrent prostate cancer, the investigators hypothesize that POMx is     effective in slowing the rise of PSA as measured by PSA doubling time in men following     initial therapy for prostate cancer. Further, the investigators believe that POMx will be     shown to be safe and well tolerated.   "
168449|NCT00033111|"     The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence   "
157602|NCT01220778|"     Background: It is now generally accepted that an active lifestyle is beneficial for     cognition, but can these benefits be transmitted for the active pregnant woman to her unborn     child? This has been demonstrated in rats where the pups born of mothers who exercised during     pregnancy had increased hippocampal neurogenesis and better memory and learning capabilities.     Human studies tend to confirm this by looking at behavioral results, ie. better orientation     and state regulation skills in newborns. The aim of the present study is to verify this on     the electrophysiological level and to determine the effects of an active lifestyle during     pregnancy on the newborn's brain development.      Methods: 60 pregnant women will be included in a randomized controlled trial. The exercise     group will be asked to exercise a minimum of 20 minutes, 3 times per week, at a minimal     intensity of 55% of their maximal aerobic capacity. The control group will not be given     exercise counselling. Newborns' brain activity will be recorded using electroencephalography     (EEG) 10 days post partum. The primary outcome measure will be the amplitude and latency of     the mismatch negativity (MMN), a component of the auditory event-related potential (ERP) that     can be used to investigate the auditory sensory memory.   "
157603|NCT01220765|"     Rationale: The current standard of respiratory monitoring for patients during deep sedation     is continuous pulse oximetry with visual assessment of the patient. Clinical research has     demonstrated that depressed respiratory activity is a principal risk factor for hypoxemia     during sedation. Capnography may provide early detection of alveolar hypoventilation before     hypoxemia has occurred in nonintubated patients and thereby improve patient safety during     sedation.      Objective: At the Centre for Contraception, Sexuality and Abortion Leiden, abortion     procedures are performed under deep sedation using propofol. Patient's monitoring is     performed by nurses qualified in patient sedation management, using pulse oximetry and their     clinical judgement. The aim of this study is to examine the effectiveness of capnography in     early detection of alveolar hypoventilation during deep sedation in comparison to standard     monitoring with pulse oximetry in abortion procedures.      Study design: This protocol describes a prospective, open, randomized controlled trial with     two study arms. All patients receive standard care of monitoring performed by the medical     staff. The study investigates whether capnography prevents patients from having respiratory     events during deep sedation in abortion procedures by early detection and therapy. Patients     randomized to the standard care group receive standard of respiratory monitoring using pulse     oximetry. In the capnography arm, respiratory monitoring is performed with pulse oximetry and     capnography.      Study population: The study population comprises female patients (≥ 18 years) undergoing     abortion procedures during first or second trimester pregnancies. Abortion procedures are     performed until 22 weeks of gestational age.      Capnography: In addition application of capnography during deep sedation with propofol is     performed. Before the trial starts, all nurses qualified in patient sedation management and     abortion doctors will be trained in assessment of capnography. In the capnography arm,     patients' breathing is additionally monitored with capnography. If alveolar hypoventilation     is detected medical staff will intervene by arousing the patient, performing chin lift,     repositioning the head, provision of oxygen, or abandon from giving additional propofol.     These interventions represent the standard of care currently used by the clinical staff to     respond to hypoventilation and hypoxemia.      Main study parameters/endpoints: The primary outcome is the occurrence of oxygen saturations     to ≤90% in the population, as measured by continuous pulse oximetry. Secondary study outcomes     include occurrence of oxygen saturations < 80%, dose of administered propofol, arousal or     movement of the patient during the procedure, airway interventions, early termination of the     procedure due to respiratory problems, episodes of bradycardia, and administration of     atropine.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The risks related to the conduct of this study are negligible and the burden     minimal. Patients in both groups receive the current standard of care. Patients randomized in     the capnography group could get benefit from the addition of capnography to the monitoring by     early detection of alveolar hypoventilation. Capnography is a noninvasive measurement by     means of a cannula under the nose, which before the sedation may tickle, but during sedation     no inconvenience is expected.   "
157604|NCT01220752|"     The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity and     efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and     carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local     control, disease-free survival, overall survival, and toxicity. Planned accrual of the trial     includes 36 patients with histologically proven (≥R1-resected or inoperable) sinonasal     malignancies.   "
157691|NCT01219608|"     This is a double-blinded placebo-controlled block randomized study in intensive care patients     comparing enteral glutamine supplementation to placebo. The hypothesis is an improvement of     clinical and paraclinical outcomes. The primary endpoint is Infection Probability Score (IPS)     and Systemic Inflammatory Response Syndrome (SIRS). Anthropometric measures and serum     inflammatory mediators will be compared.   "
157605|NCT01220739|"     To assess the safety and preliminary efficacy of combining intravenous rt-PA with     transcranial laser therapy (TLT) with the NeuroThera® Laser System (referred to hereafter as     NTS) in subjects treated for acute ischemic stroke. Treatment with IV rt-PA must begin within     3 hours of symptom onset, and the initiation of TLT procedure must be feasible for each     subject within 6 hours of stroke onset. The NeuroThera® Laser System is an investigational     device that provides noninvasive transcranial laser therapy to subjects diagnosed with acute     ischemic stroke. The wavelength of the laser light is in the infrared zone of the     electromagnetic spectrum and is invisible to the naked eye.   "
157606|NCT01220726|"     This is a prospective, randomized, double-blind study comparing intravesical injection of     BOTOX to placebo. Study subjects will be randomized (1:1 ratio) to one of the following     treatment groups:      Group 1 n=20 BOTOX® 200U Group 2 n=20 Placebo BOTOX® (saline) At Visit 2 (Treatment, Day 0),     subjects will receive one injection cycle of BOTOX (200U) or placebo (saline). The study     duration is approximately 284 days and consists of a Screening Visit (Day -7 to -14), a     Treatment/Randomization Visit (Visit 2, Day 0), and Follow-up Visits at 7, 30, 90, 180, and     270 Days. Telephone Follow-ups will be made 3 days following the injection cycle.      Subjects demonstrating an insufficient response to treatment may receive an open-label     injection cycle of BOTOX (200U) at Day 90. Subjects receiving this injection will re-commence     Follow-up Visits and be followed for an additional 270 days.   "
157607|NCT01220713|"     The goal of this research is to serve as a demonstration project to determine the     tolerability of individuals with persistent post-concussive symptoms from combat-related mild     TBI (traumatic brain injury), identify dose-finding for HBO2 (Hyperbaric Oxygen) therapy, and     determine the efficacy of HBO2 therapy.   "
157608|NCT01220700|"     The purpose of this study is to determine if suture material coated by antimicrobial agent     triclosan would decrease the incidence of surgical site infections (SSIs) in paediatric     surgery compared to ordinary sutures.      1500 children (age form 4 weeks to 18 years) coming for general pediatric surgery to the Oulu     University Hospital are randomised to have sutures coated with triclosan (Vicryl Plus,     Monocryl Plus) or ordinary sutures. The occurrence of SSIs is monitored by email     questionnaires to the parents on days 10 and 30. The diagnosis of SSIs are made along CDC     criteria.   "
157609|NCT01220687|"     This study hopes to determine whether nitric oxide along with oxygen during the first 20     minutes of life in infants needing help with breathing will reduce the percentage and total     exposure to oxygen during that time frame. Although the use of oxygen in management of     breathing is an important part of supporting baby immediately after delivery, there is more     evidence that too much exposure to oxygen may lead to potential problems for your baby later.     Oxygen exposure can be harmful to premature babies developing lungs.   "
168450|NCT00033124|"     The purpose of this study is to examine behavioral treatment for methamphetamine dependence.   "
157610|NCT01220674|"     The investigators are developing a computer-based neuropsychological assessment tool to help     primary care physicians detect neurological and psychiatric disorders. To confirm the tool's     efficacy, the investigators will first test the prototype against established tests. The     investigators propose to collect preliminary data on a limited group of subjects and     age-matched controls. Collecting data on a limited group of subjects provides early insight     into how well the tool detects disease, how well patients understand the instructions and     enjoy performing the tasks, and if particular trials or stimuli are too difficult or too easy     for all subjects. With this information, the investigators can make adjustments to the tool     if needed and collect additional data on revised versions of the tool. The data will be used     to establish the validity, reliability and sensitivity of the tool to generate consistent and     accurate scores. The investigators will initially focus on a limited age range (age     fifty-five to seventy-five) and limited set of diseases (early dementias or mild cognitive     impairment) to reduce variability within the patient and control groups and to gain more     statistical power with a smaller group of subjects.   "
157611|NCT01220661|"     In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use     of antibiotics for colorectal surgery is three doses.      It has been reported that the surgical site infection rates of laparoscopic colorectal     surgery are lower than open colorectal surgery. However, the evidence of proper application     of antibiotic for laparoscopic colorectal surgery is still not enough.      The investigators are researching the efficacy and safety of one dose prophylactic antibiotic     in laparoscopic colorectal surgery.   "
157612|NCT01220648|"     This study will assess the maximum tolerated dose of low dose interferon in conjunction with     nilotinib in pretreated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia     patients in chronic phase (CML-CP).   "
157613|NCT01220635|"     This study aims to evaluate the short-term and long-term efficacy of two preventative     intervention approaches designed to support middle school youth.   "
157614|NCT01220622|"     The trial was designed to test the hypothesis that early treatment with nimodipine has a     positive effect on cognition impairment after acute ischemic stroke.   "
157615|NCT01220609|"     This phase II trial is studying the side effects and how well ixabepilone works in treating     patients with recurrent or persistent leiomyosarcoma of the uterus previously treated with     chemotherapy. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.   "
157616|NCT01220596|"     Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with     Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B.        -  Increased HBeAg seroconversion rate        -  Increased HBsAg loss rate        -  To define the best treatment condition for chronic HBV hepatitis patients   "
157617|NCT01220583|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. It is not yet known whether     radiation therapy is more effective when given together with chemotherapy or alone after     surgery in treating salivary gland tumors.      PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without     chemotherapy to see how well it works in treating patients with high-risk malignant salivary     gland tumors that have been removed by surgery.   "
157618|NCT01220570|"     This clinical trial will evaluate whether treatment with ridaforolimus, dalotuzumab, or     ridforolimus/dalotuzumab combination therapy reduces Growth Factor Signature (GFS) Score     among participants with breast cancer.   "
157620|NCT01220544|"     Experimental and clinical data suggest that alloreactive NK cells can reduce the risk of     graft-rejection, GvHD and leukemic relapse after HLA-mismatched transplantation. The     effectiveness of allogeneic NK cells is a function of HLA-differences between donor and     recipient that give rise to NK cell clones which do not express inhibitory receptors matching     for the HLA molecules of the recipient. Aim of the study is to evaluate cellular therapy with     alloreactive, IL-2 activated NK cells after transplantation of T-cell depleted stem cell     grafts from one haplotype mismatched family donors in patients with hematological     malignancies.   "
157621|NCT01220531|"     Complete DiGeorge anomaly (cDGA) is a disorder in which there is no thymus function. With no     thymus function, bone marrow stem cells do not develop into T cells, which fight infection.     Complete DiGeorge anomaly patients cannot fight infection and are immunodeficient. Without     successful treatment, cDGA patients usually die by age 2 years.      Thymus transplantation with and without immunosuppression (drugs given before and after     transplantation) has resulted in the development good T cell function in complete DiGeorge     anomaly subjects.      This Phase I/II study continues thymus transplantation safety and efficacy research for the     treatment of complete DiGeorge anomaly. Eligible participants undergo thymus transplantation     and biopsy. Immune function testing is continued for one year post-transplantation.   "
157622|NCT01220518|"     This study is the trial to demonstrate how our product is similar to remicade by comparing     the results of blood samples in active Ankylosing Spondylitis patients.   "
157623|NCT01220505|"     The purpose of this Post Market Surveillance Validation is to document the performance and     clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity     Correction System.   "
157624|NCT01220492|"     Liver cirrhosis (LC) represents a late stage of progressive hepatic fibrosis characterized by     distortion of the hepatic architecture and formation of regenerative nodules. The liver     transplantation is one of the only effective therapies available to such patients. However,     lack of donors, surgical complications, rejection, and high cost are it`s serious problems.     The potential for stem cells to differentiate into hepatocytes cells was recently confirmed.     Particularly, autologous bone marrow-derived mesenchymal stem cell (BM-MSC) has been     demonstrated to decrease MELD score and increase serum albumin in 4 of patients with     decompensated liver cirrhosis. Therefore, the investigators propose a hypothesis that     umbilical cord-derived MSCs (UC-MSC) can also improve the disease conditions of LC patients,     particularly reducing the decompensated conditions in these patients.   "
157652|NCT01220128|"     The purpose of this study is to evaluate the safety, immunogenicity and clinical activity of     a new WT1 anti-cancer immunotherapy in patients with WT1-positive Stage II or III breast     cancer. The treatment will be given before surgery in combination with standard therapy.   "
157625|NCT01220479|"     Type 1 diabetes mellitus (T1DM) is associated with multiple co-morbidities, such as     hypertension, dyslipidemia, coronary heart disease and osteoporosis. The foundation of these     conditions lays in childhood. Exercise is known to have a positive influence on bone mineral     density (BMD) and some impact on cardiovascular disease risk factors in healthy children, but     little is known about these associations in children with T1DM.      The main purpose of this study is to assess the effects of a 9-month weight-bearing exercise     training program on skeletal development in children with T1DM, compared to healthy subjects.     The second aim is to evaluate whether the program influences also cardiovascular diseases     risk factors.      This is a randomized controlled study incorporating 30 children with T1DM and 30 healthy     children. Both groups are randomly divided (1:1) in an exercise or a control group: 1)     exercise diabetic, 2) controls diabetic, 3) exercise healthy, 4) controls healthy.      Exercise groups participate to an identical weight-bearing exercise training program 2 x 90     minutes per week and controls are relatively inactive.      Main measures include: total body, lumbar spine and hip BMD by DXA, body fat and fat-free     mass, bone biomarkers levels, resting and ambulatory blood pressure and fasting blood lipids.   "
157626|NCT01220466|"     The results of this trial will demonstrate that the iDesign System performs as intended and     is acceptable in a clinical setting.   "
157627|NCT01220453|"     The present trial is aimed to document efficacy (bowel cleanliness), acceptance and     tolerability as well as patient comfort in the use of the new bowel cleansing product     PICOPREP® in every day practice. In particular, it should be evaluated, whether bowel     cleanliness, acceptance, tolerability and patient comfort are affected by specific practice     procedures, changes in dose etc.   "
157628|NCT01220440|"     The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on     neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD     within a double-blind cross-over design over six weeks. The assessment of ADHD followed     formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A     neuropsychological testbattery and four behavioral questionnaires were selected as efficacy     variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory     control, motor activity), Score (auditory attention), Stroop Test (processing speed,     inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on     each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed     by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by     the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed     by a parent and a teacher Monday till Friday through every week), Test Performance     Questionnaire (completed by the child immediately after each of the three test sessions).      Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will     provide better results than a trial including only Met. a)Met and Dex are efficient as     treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to     Met. b)At an individual level some of the participants will show positive response to one     type of stimulants and no response, mixed response or adverse response to the other type of     stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in     agreement but also add unique information in the assessment of the effect of stimulants.     d)Qb-test is sensitive and valid as a measure of the effect of stimulants.   "
157629|NCT01220427|"     The purpose of this study is to determine whether specific Micro-RNA expression profiles are     related to Prostate cancer outcome.   "
157630|NCT01220414|"     The purpose of this study is to examine opioid and endocannabinoid mechanisms of     exercise-induced analgesia in men and women.   "
157631|NCT01220401|"     The purpose of this study is to find out what effects Exposure, Rescripting, and Relaxation     Therapy (ERRT) has on nightmares and associated problems in veterans.   "
157641|NCT01220271|"     The purpose of this trial is to show proof of concept that by blocking the Transforming     Growth Factor-beta signaling pathway in patients with Glioblastoma, there will be clinical     benefit.      Phase 1b: To determine the safe and tolerable dose of LY2157299 in combination with     radiochemotherapy with temozolomide for Phase 2 in patients with glioma eligible to receive     radiochemotherapy with temozolomide (e.g. newly diagnosed malignant glioma World Health     Organization Grade III and IV).      Phase 2a: To confirm the tolerability and evaluate the pharmacodynamic effect of LY2157299 in     combination with standard radiochemotherapy in patients with newly diagnosed glioblastoma.   "
157632|NCT01220388|"     Data from the literature and previous in vitro research conducted in the investigators'     laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid     secretion might be controlled by a paracrine mechanism involving serotonin type IV receptor     (5-HT 4). L-lysine, a common amino-acid has been shown to act as a 5-HT4 agonist in vitro as     well as in vivo. In the present physiology trial, plasma aldosterone and cortisol levels will     be measured under treatment with aprepitant versus placebo, in both basal conditions and     after activation of the adrenocortical function by various stimuli, including upright     posture, metoclopramide, and after a 3 days salt-free diet. All healthy volunteers will be     given two substances (L-lysine and placebo) in a random order during two 13 days periods     separated by a 14 day-wash-out. This study should allow to determine the role of 5-HT4     receptors in the control of corticosteroid production in normal man.   "
157633|NCT01220375|"     High-dose chemotherapy with autologous stem cell support is the current standard procedure in     the first-line treatment in younger patients with myeloma fit for intensive treatment.     Current practice in Switzerland for stem cell mobilization is the combination of chemotherapy     and G-CSF stimulation in myeloma patients fit for high-dose chemotherapy with melphalan and     autologous stem cell transplant. In this trial the intravenous application of Plerixafor is     being investigated in respect of the capability of the mobilization of stem cells from the     bone marrow into the peripheral blood. In contrast to the twice daily application of G-CSF     (eg. Neupogen) for several days, Plerixafor has to be injected just one-time.   "
157649|NCT01220167|"     The purpose of this study is to compare dosing effect of water on the single dose     bioavailability of Ondansetron ODFS 8mg (MonoSol Rx, USA) administered with and without water     to Zofran ODT® 8mg administered without water in healthy male and female adult, human study     participants under fasting conditions.        -  To monitor clinical status, adverse events and laboratory investigations, and to assess          the relative safety and tolerance of the study drug formulations under fasting          conditions.        -  To estimate intra-subject coefficients of variation (CV).   "
157650|NCT01220154|"     Phase I study to evaluate intraperitoneal carboplatin along with weekly intravenous     paclitaxel and bevacizumab in order to establish a tolerable dose and define the toxicity of     this regimen in previously untreated patients with advanced ovarian carcinoma.   "
157651|NCT01220141|"     This study is conducted in Europe and Asia. The aim of this observational study is to monitor     antibody formation towards the room temperature stable formulation of NovoSeven® (activated     recombinant human factor VII).   "
168504|NCT00033891|"     This study will examine whether infliximab (Remicade ) is safe and effective for the     treatment of dermatomyositis and polymyositis. Infliximab blocks the effect of a protein     called tumor necrosis factor (TNF), which is associated with harmful inflammation in many     diseases.      Patients 18 years of age and older with active dermatomyositis or polymyositis that does not     respond adequately to treatment with methotrexate and corticosteroids may be eligible for     this study. Candidates will be screened with a medical history, physical examination, blood     and urine tests, chest x-ray, pulmonary function test, skin test for tuberculosis, HIV test,     electromyography (described below), manual muscle testing, and functional assessments.     Magnetic resonance imaging (described below) will be done to assess the degree and location     of inflammation in the involved limbs. An electrocardiogram and echocardiogram will be done     if recent ones are not available. Patients who qualify for the study will be asked to undergo     two muscle biopsies (surgical removal and analysis of small pieces of muscle tissue), one     before initiation of treatment and another on the 16th week .      Participants will be randomly assigned to receive either 3 mg/kg body weight of infliximab or     a placebo (inactive substance) by infusion through a vein over 2 hours. The infusions will be     given at the beginning of the treatment period (week 0) and at weeks 2, 6 and 14. At week 16,     strength will be assessed by manual muscle testing. Patients who improved with treatment will     continue with the same infusion dose on weeks 18, 22, 30, and 38. Those who do not improve     will be assigned by random allocation to receive either 5 mg/kg body weight or 10/mg/kg body     weight of infliximab on weeks 18, 22, 30 and 38. Those who did not improve who were     previously on the placebo infusion will receive an extra dose of either 5 mg/kg or 10 mg/kg     body weight of infliximab on week 16, while those patients who were previously on 3 mg/kg     body weight of infliximab who failed to meet the improvement criteria will receive an     infusion containing no medication on week 16. Patients will be admitted to the hospital for     infusions at weeks 0, 14 and 38; the rest will be given on an outpatient basis. After the     38th week, all infusions will be stopped and patients will be assessed on the 40th week.      Participants will undergo some or all of the following tests and evaluations during     treatment:        -  Blood tests every week to look for antibodies seen with muscle inflammation. Some of the          blood samples will be stored for later testing, including genetic studies to find          genetic differences related to inflammation.        -  Skin test for tuberculosis        -  Chest x-rays at the beginning of the study (if a recent one is not available) and again          at weeks 16 and 40 to look for active infection, detect signs of past exposure or          infection with diseases such as tuberculosis, and assess the presence of lung disease          that might be related to the myositis.        -  MRI (usually of the legs) at the beginning of the study and again at weeks 16 and 40 to          measure disease activity and extent of muscle involvement. This will also give an idea          of the response to treatment. This test uses a magnetic field and radio waves to produce          images of body tissues. During the procedure the patient lies on a bed surrounded by a          metal cylinder (the scanner).        -  Muscle biopsy at the beginning of the study to diagnose muscle inflammation and again at          week 16 to evaluate the response to treatment.        -  Electromyography if the patient has not had an EMG previously. For this test, small          needles are inserted into the muscle to assess the electrical activity of the muscle        -  HIV test      Patients whose disease worsen with treatment or who develop serious drug-related side effects     will be taken off the study and referred back to their primary care physician for further     therapy. Patients who improve will be referred back to their primary physician at the end of     the study for possible continued treatment. Participants will be asked to return for     follow-up visits every 6 weeks for a total of 30 weeks to monitor long-term effects of the     drug   "
157634|NCT01220362|"     Postoperative urinary retention (POUR) is one of the most common complications after surgery     and neuraxial anesthesia of which the treatment of choice is bladder catheterization 1. It     has been a common practice to place an indwelling catheter in the bladder in patients     receiving epidural analgesia and to leave the catheter as long as the epidural analgesia is     maintained despite a lack of evidence supporting this approach.      Transurethral catheterization is associated with significant morbidity such as patient     discomfort, urethral trauma and urinary tract infections (UTI). Prolonged catheterization is     the primary risk factor for catheter associated UTI (CAUTI), which is one of the most common     nosocomial infections and can prolong hospitalisation 2. For this reason there is a growing     focus on limiting the duration of catheterization and finding methods to avoid unnecessary     catheterization in perioperative medicine 3,4.      Lower urinary tract function depends on coordinated actions between the detrusor muscle and     the external urethral sphincter. Motorneurons of both muscles are located in the sacral     spinal cord between L1 and S4. Most afferent fibers from the bladder enter the sacral cord     through the pelvic nerve at segments L4-S2.      Because epidural analgesia can be performed at various levels of the spinal cord, it is     possible to block only a portion of the spinal cord (segmental blockade). Based on the     innervation of the bladder and sphincter between L1 and S4 it can be assumed that epidural     analgesia within segments T4-6 to T10-12 has no or minimal influence on lower urinary tract     function.      In a previous study, we found, against our expectations that thoracic epidural analgesia     (TEA) significantly inhibits the detrusor muscle during voiding, resulting in clinically     relevant post-void residuals which required monitoring or catheterisation 5. Because the     study adopted a before-after design, we could not definitively identify the mechanisms     responsible for this change in bladder function. In particular, we could not determine     whether TEA per se or surgery was the main cause. Concerning TEA, it remains unclear which     compounds of the solution, the local anesthetic, the opioid or both are responsible for the     observed changes in lower urinary tract function.      The aim of this study is to compare lower urinary tract function before and during TEA with     two different epidural solutions (group 1: bupivacaine 1.25 mg/ml vs group 2: bupivacaine     1.25 mg/ml combined with fentanyl 2 µg/ml) within segments T4-6 to T10-12 for postoperative     pain treatment in patients undergoing lumbotomy for open renal surgery.      We expect that a better understanding of lower urinary tract function during TEA could lead     to a more restrictive use of indwelling transurethral catheters perioperatively.   "
157635|NCT01220349|"     Despite careful monitoring of patients with diabetes, it is so far difficult to predict the     occurrence of cardiac events in the evolution. As shown by various studies conducted in     patients with diabetes, cardiac involvement can be detected by abnormalities of diastolic or     systolic functions using non-invasive investigations such as echocardiography. For 4 years,     the evaluation technique of myocardial deformations by two-dimensional speckle tracking     strain by echocardiography is the subject of high hopes in the earlier detection of still     asymptomatic cardiomyopathies. In the present study, the investigators hypothesized that this     technique would improve the detection of myocardial contraction abnormalities in patients     with insulin-dependent diabetes mellitus (IDDM), and would establish their association with     micro-angiopathy, frequently encountered in these patients.   "
157636|NCT01220336|"     Randomized control trial studying the effect of medical assistant health coaching for     patients with diabetes, hypertension and hyperlipidemia within two San Francisco primary care     community clinics, Mission Neighborhood Health Center and Southeast Health Center   "
157637|NCT01220323|"     In the present study, the investigators intend to investigate whether anodal transcranial     direct current stimulation (tDCS) may be effective in reducing pain in chronic pain patients.   "
157638|NCT01220310|"     Doctors and web-based self-management support pilot study will test whether health     professionals' observation of an online patient workshop on self-management of diabetes and     participation in structured learning sessions on self-management strategies will change the     attitudes and confidence of physicians and other health professionals regarding their     willingness and ability to perform self-management interventions with patients. If this pilot     suggests that attitudes and confidence levels can change, we hope to launch a larger study to     examine this method of learning and its effectiveness in more detail.   "
157639|NCT01220297|"     A continuation study of sirolimus and mycophenolate mofetil (MMF) for graft-vs-host disease     (GvHD) prophylaxis for patients undergoing matched related allogeneic hematopoietic stem cell     transplantation (HSCT) for acute and chronic leukemia, myelodysplastic syndrome (MDS), high     risk non-Hodgkin lymphoma (NHL), or Hodgkin lymphoma (HL)   "
157640|NCT01220284|"     Vinorelbine (NVB) and platinum compounds are anticancer agents with broad spectrum of     efficacy, clinically and preclinically proven synergism and only partially overlapping     toxicities. Combinations with vinorelbine and platinum compounds with limited neurotoxicity     are among the most used palliative regimens in a variety of solid tumors, including NSCLC,     breast and cervical cancer. The oral platinum analogue satraplatin (SATRA) has been brought     into clinical development because of the antitumor activity and toxicity comparable to those     of carboplatin, together with a good acceptability of the oral administration.The recent     availability of oral formulation of anticancer agents of proven efficacy in some indications     is likely to become a valid option which could affect clinical daily management. The oral     administration of vinorelbine and satraplatin might represent a reasonable option of     palliative treatment in patients with advanced breast cancer, NSCL, GU or GY tumors for which     a curative treatment can not be provided.   "
157692|NCT01219595|"     The purpose of the research is to determine if eating sweetened, dried cranberries or     strawberry fruit pieces will increase the types of different E. coli bacteria in the     intestines which may reduce the likelihood of a major, or highly harmful urinary type of     bacteria which cause urinary tract infections in susceptible women.   "
157643|NCT01220245|"     In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be     compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority     principle for the patency. Besides equal patency, an improved quality of life is expected.     Recruitment will take the first two years and patients will be followed during five years.     Patients with an indication for surgical bypass, classified category 3-6 with a >50% stenosis     or occlusion of the SFA over >/=10 cm in length will be included. At least one crural artery     should be patent without significant lesions.   "
157644|NCT01220232|"     This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male     and/or female subjects, to estimate the effect of steady state lersivirine on the steady     state pharmacokinetics of abacavir/lamivudine.   "
157645|NCT01220219|"     The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two     pregabalin controlled release tablets as compared to multiple doses of the pregabalin     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two     pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate     release capsule and 3) evaluate the safety and tolerability of multiple doses of two     pregabalin controlled release tablets as compared to multiple doses of the pregabalin     immediate release capsule.   "
157646|NCT01220206|"     POMx can be used as a treatment for erectile dysfunction.   "
170212|NCT00065429|"     This study was a Phase I/II trial primarily focused on efficacy of BB-10901 in relapsed small     cell lung cancer and other solid tumors.   "
157654|NCT01220102|"     The purpose of this observational study is to assess the efficacy of Epiduo and patient     adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years)     with moderate inflammatory acne using this drug first time in topical monotherapy.   "
157655|NCT01220089|"     The study has two primary aims. The first aim is to assess the efficacy of adding in-person     visits to the use of portion-controlled foods for long-term weight loss. The second aim is to     assess the use of trained lay counselors for the maintenance of weight loss. The primary     endpoint of the study will be changes in weight. Secondary endpoints will include changes in     body mass index (BMI), cardiovascular risk factors, health-related quality of life, and     cost-effectiveness. The addition of in-person visits with the weight loss counselor is     predicted to lead to greater long-term weight loss than the use of portion-controlled foods     alone.   "
157656|NCT01220076|"     The biological response to treatment with tamoxifen in the preoperative situation is studying     in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +.      The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of     TAM will be studied.   "
157657|NCT01220063|"     The purpose of this study is to study stereotactic radiotherapy with a dose of 40 Gy in 4     fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation     session).   "
157658|NCT01220050|"     The risk of fracture for kidney transplant recipients is 4 times higher that of the general     population. The hyperparathyroidism plays a key role in the maintenance or development of     post-transplant alterations of bone remodelling.      Renal transplant patients are at high risk of hyperparathyroidism, largely because of     long-lasting renal insufficiency before transplant, and of progressive deterioration of     kidney function because of chronic allograft nephropathy (a disease of proteinuria and     progressive decline of the glomerular filtration rate).In hemodialysis patients, intravenous     paricalcitol (19-nor-1,25-dihydroxyvitamin D2), a new vitamin D analogue, achieves a faster     and more effective normalization of parathyroid hormone (PTH) levels than calcitriol     (1,25-dihydroxyvitamin D3), an effect that is associated with smaller changes in serum     calcium and phosphorus levels.      Whether oral paricalcitol may help achieving a prompt reduction in serum PTH levels and,     secondarily, in urinary protein excretion in renal transplant recipients with secondary     hyperparathyroidism is worth investigating.   "
157659|NCT01220037|"     In the present study, the effects of age and dietary intake will be assessed on myocellular     characteristics during 72 hours after a resistance type exercise session.   "
157660|NCT01220024|"     This study will assess pain intensity for the first 72 hrs after after aggravated movement     (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the     CollaRx Bupivacaine implant or a plain collagen sponge.   "
157661|NCT01220011|"     The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser     surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an     international randomized controlled trial. This trial will answer an important question and     will help in the management and tailoring of surgical indications in stage 1 TTTS.   "
157662|NCT01219998|"     Urinary NGAL has been shown to be an early marker of acute kidney injury (AKI) following     paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early increase     of urinary NGAL following cardiopulmonary bypass was predictive of AKI. Several studies     included heterogeneous populations of children undergoing cardiac surgery, but NGAL has not     been studied in neonates after open heart surgery, neither has been identified the threshold     for accurate prediction of severe AKI requiring renal replacement therapy.      The aim of this observational cohort study is to describe postoperative kinetics of urinary     NGAL in neonates and to identify the threshold for accurate prediction of severe AKI     requiring renal replacement therapy in neonates and infants undergoing cardiac surgery   "
157663|NCT01219985|"     Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer     imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism.     In case of cancer, metabolism is, classically, increased and some hot spots are visible on     PET images. Because of respiratory motion and because the liver is intrinsically FDG avid,     some tumours (especially the smallest ones) can be occulted and missed by the clinician.      The investigators developed a respiratory-gated PET method in order to reduce the motion     issue. This protocol has been validated on lung pathologies. The investigators designed a     study to investigate its effect on liver cancer (primary or metastasis) to check if it allows     the detection of a higher number of tumour lesions.      To that aim, patients who are planned to undergo a surgical intervention on the liver can be     proposed to participate this study. After the standard PET acquisition (acquired in     free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed     without additional injection. After that, a breath-hold (~10s) CT is performed.   "
157664|NCT01219972|"     This is a prognostic study of the late lung complications arising at the patient's having     received an allograft of hematopoetic stem cells.   "
157665|NCT01219959|"     Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal,     Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous     Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as     measured by the magnitude of change from the baseline value in the HbA1c levels.      Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis     solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to     lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic     events requiring medical intervention, improved metabolic control, nutritional status, and     Quality of Life.   "
157696|NCT01219543|"     This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability     of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in     patients with advanced HCC (Part B) in the escalation phase, EGFR or ROS mutant NSCLC and     non-smokers with lung metastasis and gastric cancer in the expansion phase and to evaluate     daily and BID dosing.   "
157697|NCT01219530|"     To explore the attitudes and reactions of gestational carriers and intended parents though     their medical, pregnancy and postpartum experiences.   "
158120|NCT01214291|"     The purpose of this study is to determine whether Toremifene Citrate is effective in reducing     the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation     Therapy.   "
157666|NCT01219946|"     Chronic obstructive pulmonary disease (COPD) is characterized by a progressive decline in     lung function and increased symptoms such as breathlessness/dyspnoea, cough and     expectoration.      Even though subjective in nature, the symptomatology of COPD and mainly that of     breathlessness/dyspnoea has been studied with the use of objective measurement tools. Taking     into consideration that the symptoms experienced by the patient who suffers from a     progressive disease such as COPD can only be perceived and interpreted by the patient him- or     herself, and thus difficult to be quantified, COPD remains a challenge in clinical research.      Therefore, there is a need to carry out qualitative studies that will provide insight into     the wide spectrum of COPD symptomatology from the patient's perspective. In addition, a     further mapping of the impact that COPD symptoms' perception has on a patient's life is     required, as well as of the different pathways through which symptoms' perception is     interpreted regarding the limitations of daily living activities, and the subsequent impact     on disease management. The more the physician learns on the embodied experience of COPD, the     better he/she may assist the patient in achieving optimal COPD management.      Thus this cross-sectional observational study was designed aiming to obtain these data.     Specifically, the study aims to evaluate the most frequently used words by the patients and     the physicians to express the symptoms of COPD as well as the limitation of activities that     it causes.   "
157667|NCT01219933|"     This open-label, single-arm study will assess the use of glucocorticoids (GC) in daily     clinical practice and will evaluate the dose reduction of glucocorticoids once low disease     activity is achieved in patients with rheumatoid arthritis tre ated with GC and background     RoActemra/Actemra (tocilizumab) 8mg/kg intravenously every 4 weeks. In the non-interventional     phase, the use of GC in daily clinical Belgian practice will be evaluated and described. This     period of maximum 6 mont hs will allow those patients to obtain the inclusion criteria for     the secondary interventional phase. In the interventional phase, a systematic GC dose     reductio n schedule will be evaluated in patients having achieved low disease activity wh ile     receiving the same background therapy with RoActemra/Actemra 8 mg/kg. Methyl prednisolone     will be given from a starting dose of >/= 1 mg to </=20 mg orally d aily and will be tapered     down. The anticipated study duration is up to 13 months   "
157668|NCT01219920|"     The purpose of the study is to evaluate if the exposure to all the three active cytotoxic     agents (FOLFOXIRI regimen) is superior in terms of response rate to conventional chemotherapy     with the FOLFIRI regimen as first-line treatment of metastatic colorectal cancer patients.   "
157669|NCT01219907|"     RATIONALE : Laboratory-treated T cells may stimulate the immune system in different ways and     stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Vaccines made from HER2 peptides may help the body build an effective     immune response to kill tumor cells that express HER2. Giving laboratory-treated T cells and     cyclophosphamide after vaccine therapy may be an effective treatment for breast cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of ex vivo-expanded     HER2-specific T cells when given together with cyclophosphamide after vaccine therapy in     treating patients with HER2-positive stage IV breast cancer.   "
157710|NCT01219361|"     Couples who have created excess embryos while undergoing IVF procedures, and who do not wish     to transfer those embryos or donate them to another couple may donate the extra embryos to     research. The embryos are then used to develop improved laboratory techniques and conditions     as well as testing the proficiency of laboratory staff.   "
157725|NCT01219166|"     Gallbladder management in bariatric surgery is controversially discussed. While some surgeons     advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass (RYGB)     others advocate CCE only in patients with pathological gallbladder findings. The aim of this     study was to evaluate the necessity of prophylactic CCE in patients receiving a laparoscopic     RYGB.   "
157670|NCT01219894|"     Patients who receive drug-coated stents (as opposed to the less frequently used bare metal     stents) are currently recommended aspirin plus a thienopyridine such as Plavix, Effient, or     Ticlid for one year. These guidelines apply to all patients with drug-coated stents,     regardless of the type of stent they received. The purpose of these medications is to prevent     a clot at the stent site when there is poor healing of artery tissues over the stent. A clot     is a serious concern because it can suddenly block blood flow to the heart and cause a heart     attack. These medications have been proven to be helpful in stent patients, but they do have     risks. The common side-effects are related to bleeding which in a few patients can be     serious. A patient may be at risk for forming a clot if they must put these medications on     hold for a surgical procedure to reduce the risk of bleeding. Plavix and Effient are also     expensive for patients who are underinsured or uninsured. There is interest is finding a way     to show that a patient's stent has healed properly before 12 months and that they can safely     stop these medications early.      This study is looking at a way to determine if patients who receive the Endeavor drug-coated     stent and who are prescribed aspirin and Plavix can safely stop Plavix at 3 months instead of     12. Previous studies have shown 99.9% coverage of the body's own tissues on an Endeavor stent     after 3 months.      A device called an Optical Coherence Tomography (OCT) catheter will be used in this study to     look at how much a stent has healed. It allows imaging inside a heart artery and the ability     to see the healing of tissues over the stent.   "
157671|NCT01219881|"     This is a single-center, prospective, randomized, double-blind, double-arm trial including 68     subjects scheduled to undergo urological cystoscope surgeries under general anesthesia (GA)     with intubation through a laryngeal mask airway (LMA) at The Ohio State University Medical     Center (OSUMC). Double blinding will be based on both the subject and the research staff     being unaware of which trial arm the subject is randomized into. Eligible subjects that     provide voluntary and written informed consent will be included in this study.   "
157672|NCT01219868|"     The objective of this study is to explore the impact of a physician-nurse team supervising     patient's flow on ED length of stay   "
157673|NCT01219855|"     This study will investigate how the levels of a repeat dose of CTAP101 changes in the body     over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances     (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency     and secondary hyperparathyroidism (SHPT).   "
158121|NCT01214278|"     The aim of this study is to examine differences in short term bioavailability between four     n-3 FA formulations in healthy males.   "
157674|NCT01219842|"     Peripheral arterial disease (PAD) often causes exertion pain in the legs, intermittent     claudication (CI) affecting> 10% of individuals> 65 years. A recent Swedish Health Technology     Assessment Report identified only limited evidence for the effectiveness of invasive     treatment for IC in patients already on exercise training. The prognosis for the extremity is     usually benign and treatment therefore aims at improving quality of life. Invasive treatment     can also cause serious complications. Coronary artery disease is common in IC patients     increasing the risk with invasive treatment. In spite of these uncertain merits and potential     risks, invasive procedures for IC are increasing and 37% of all invasive procedures for PAD     in Sweden are performed for IC. The aim of this study is to evaluate the additional effects     of modern invasive treatment in patients with intermittent claudication receiving modern best     medical treatment (BMT). The primary hypothesis in the study is that invasive treatment in     addition to BMT improves health related quality of life and walking performance compared to     BMT only.   "
157675|NCT01219829|"     The research purpose of this project is to create a registry, and blood and tissue bank for     individuals at high-risk for pancreatic cancer. We plan to conduct histopathological and     molecular analysis of resected pancreatic tissue prospectively collected from a cohort of     pancreatic cancer patients.   "
157676|NCT01219816|"     Patients with relapsed/refractory adult acute lymphoblastic leukemia (ALL)have a very dismal     prognosis. In this case, allogeneic transplantation is the only curative treatment when     patient have obtained a second complete remission (CR. In France, in patients younger than 60     years old,the HyperCVAD regimen used by the MDAnderson in Houston is generally applied. In     older patients (>=60 years)or young patients <= 60 years no eligible for intense     chemotherapy, a combination of vincristine + Dexamethasone is generally chosen in order to     avoid too much toxicity but the result is worse in term of CR.      More than 90% of ALL with a B phenotype (2/3 of cases in adults)express the surface antigen     CD22 on leukemic blasts which thus represents an interesting target for therapy. Epratuzumab     is a humanized anti-CD22 antibody produced by Immunomedics, Inc, Morris Plain (New Jersey,     USA). Epratuzumab has already shown efficacy in lymphoma patients. Only one study, including     15 children, has been published so far reporting the efficacy and the toxicity of Epratuzumab     in the setting of ALL in monotherapy, one can observe 8 stable disease, 3 progressions and 4     partial responses. When combining chemotherapy and Epratuzumab, 9CR were observed with     acceptable toxicity. Tolerance was acceptable.      The French GRAALL group proposes to test an age-adapted combination of chemotherapy +     Epratuzumab, in refractory/relapses CD22+ B ALL patients in order to improve their prognosis,     in term of CR, survival and of number of patients eligible for allograft.   "
157677|NCT01219803|"     Ge Gen Qin Lian Decoction are one kind of Chinese prescription, and previous study showed     they had antidiabetic effects on the clinical patients and no obvious toxicity was found. The     purpose of this study was to evaluate the efficacy and safety of different dosage of Ge Gen     Qin Lian Decoction in the treatment of type 2 diabetic patients and explore relationship of     the dosage and effect and the safety of 3 dosages of Ge Gen Qin Lian Decoction.   "
157678|NCT01219790|"     This study will determine the delayed neurotoxicity (12 months) of a hypofractionated high     dose irradiation (3 Gy x 9) associated with zoledronic acid.      The administration of zoledronic acid repeat dosages defined under the Authorisation on the     Market.      All patients receive a total dose of 27 Gy divided into 3 fractions of 9 Gy performed at     least 48 hours apart each, for a treatment to J1, J3 and J5.   "
157679|NCT01219777|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous     weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with     epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive     neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo     surgery which will allow an objective measure of response to the above regimen as well as     assessment of surgical outcomes.   "
157680|NCT01219764|"     The proposed study will test the hypothesis that H. pylori can be eradicated successfully     (>85%) using half-or full-dose concomitant non-bismuth quadruple therapy regimen:     rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients     with peptic ulcers and H. pylori related gastritis.      Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be     enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests,     documenting H.pylori infection, will be randomized into one of two groups: Full dose or half     dose the concomitant regimen, with 100 patients in each group. Compliance and side effects     will be assessed, and a urea breath test will be done for all patients after 4 weeks of     therapy completion to evaluate eradication rates. Success of therapy will be evaluated     according to intent-to treat and per-protocol analyses.   "
157681|NCT01219751|"     To evaluate the efficacy and safety of sunitinib in non-clear cell type renal cell carcinoma     with the exception of pure sarcomatoid carcinoma and collecting duct carcinoma   "
157682|NCT01219738|"     Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma     membrane-mediated and do not require gene transcription and translation. One of these     non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular     smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic     receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g.     locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists     (e.g. inhaled beta-adrenergic agonists).   "
157683|NCT01219725|"     The purpose of this study was to examine the effect of 6 months moderate intensity exercise     training completed three times per week upon traditional and emerging cardiovascular disease     risk factors in postmenopausal women both with and without type 2 diabetes. These risk     factors include blood markers associated with increased risk such as cholesterol, insulin,     glucose and markers of inflammation plus measures of body fat, heart and lung fitness,     vascular stiffness and vascular function. The study hypothesised that moderate intensity     exercise training would intervene in the exaggerated risk seen in women following the     menopause, especially in those with type 2 diabetes.   "
157698|NCT01219517|"     The purpose of this study is to validate the ability to assess the genetic differences (DNA     fingerprinting) on polar bodies (excess genetic material given off from the egg) and cells so     that this technique may be used in the future to confirm markers of reproductive competence     and improve the efficiency and safety of clinical human in vitro fertilization.   "
157684|NCT01219712|"     Elderly patients undergoing surgery for proximal hip fracture have a high risk of morbidity     and mortality (M&M) postoperatively. Several studies including some from the investigators     department have shown that there is a high risk of cardiovascular complications in this group     of patients and 3-month mortality is 15-20%. One of the causes of this high M&M is the high     incidence of cardiac failure associated with an increased NT-proBNP in this group of     patients. The aim of the present study is to evaluate whether optimization of preoperative     cardiac function can reduce cardiac M&M postoperatively. Following verbal consent, patients     with an increased NT-proBNP would be randomized to goal-directed preoperative optimization or     standard management according to current hospital routines. Following optimization, the     patients would be transferred to the operating rooms and subsequent management including     perioperative patient management would be left to the discretion of a specialist     anesthesiologist who is directly involved in patient care. Postoperatively, Troponin T and     NT-proBNP would be measured in all patients according to the study protocol. In addition,     major adverse cardiac events would be documented and follow-up would be done by after 30 days     and 3 months postoperatively.   "
157685|NCT01219699|"     This is a first-in-man trial, in which BYL719 will be administered to adult patients with     advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease     has progressed despite standard therapy or for whom no standard therapy exists. A combination     of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally     advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The     single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion     cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type     PIK3CA gene   "
157686|NCT01219686|"     The main purpose of this study is to determine whether the antidepressant response of     escitalopram 30mg/day or escitalopram 20mg/day + pindolol, a beta blocker, is different     (faster) compared to a standard dose of escitalopram 20mg/day.   "
157687|NCT01219673|"     The goal of this clinical research study is to compare armodafinil, bupropion, and     minocycline when given alone or in combination. Researchers want to learn about the safety     and level of effectiveness of these drugs in controlling symptoms, such as the side effects     of chemoradiation, when given to patients with head and neck cancer.   "
157688|NCT01219660|"     To determine if autotitrating positive airway pressure (APAP) naïve patients with OSA can     successfully use APAP following general anesthesia.   "
157689|NCT01219647|"     Many persons with Multiple Sclerosis ( MS) have problems with memory and thinking.Exercise     has been shown to improve memory and thinking in persons with diseases such as Alzheimer's.     This study will investigate whether a program of aerobic exercise can improve memory and     thinking in persons with MS   "
157690|NCT01219621|"     1 Purpose      In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal     high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated     bradycardia, single chamber atrial pacemakers are contraindicated although ventricular     support is only rarely needed. As a result, these patients are usually exposed to an     unnecessary high proportion of ventricular pacing due to the programming of the system to DDD     mode for preventive safety reasons. This drains the pulse generator battery, and more     importantly has long-term adverse effects on ventricular function in a subset of vulnerable     patients, leading to left ventricular (LV) asynchrony, mitral regurgitation and increased     left atrium (LA) size. The deleterious effects of right ventricular (RV) pacing, which     increased heart failure (HF) morbidity/mortality, atrial fibrillation (AF) and related     adverse events have been highlighted in several large clinical studies. Limiting RV pacing in     non-dependant patients is therefore desirable.      The Symphony DR 2550 cardiac pacemakers (SORIN Group, Montrouge, France) offer a new pacing     mode that automatically switches from AAI(R) mode to DDD(R) or DDI(R) in event of severe     atrioventricular conduction disorder, returning spontaneously to AAI(R) mode as soon as the     spontaneous AV conduction has resumed. This particular mode is called the AAIsafeR2(R).      The objective of this study is three-fold: to demonstrate that AAIsafeR2 mode (i) reduces the     percentage of ventricular pacing in patients with a spontaneous AV conduction and (ii)     prevents atrial arrhythmias by improving atrial hemodynamics and (iii) improves the long-term     hemodynamic status of implanted patients in comparison to the standard DDD mode, set with     long AV Delays (DDD Long AVD).      The scientific soundness lying in this study is a proposal of an optimal programming of     dual-chamber pacemakers (PM) with regard to the preservation of spontaneous AV conduction.   "
157759|NCT01218724|"     Objective:      to compare the single dose bioavailability of Torrent's Losartan Potassium and     Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck & Co.,     Inc.      Study Design:      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects   "
157693|NCT01219582|"     An observational and multicenter study to assess the effectiveness and safety of Glucobay®- M     under daily life treatment of type-2 diabetes patients.The study objectives are to     investigate the effectiveness and safety of Glucobay® -M on blood glucose and patients body -     weight. Glucobay®- M is taken 1-3 times daily. All patients with type 2 diabetes mellitus,     where investigator feels that addition of Glucobay®-M would be beneficial to patients will be     included in non- interventional study. The routine investigation suggested by the attending     physician will be done in diabetic patients. No additional investigation will be done for the     study purpose. The uncontrolled diabetic patient on existing treatment and prescribed     Glucobay®-M will be included in study after taking the informed consent. The patient will be     asked to attend 2 follow up visit each after 6 weeks. All patients receiving at least one     tablet will be included in the safety analysis.The study is planned to be carried out in     10000 patients from 320-350 trial sites in India.   "
157694|NCT01219569|"     This is a study to focus on the feasibility of using a monitor which may signal loss of     visual function intraoperatively.   "
157695|NCT01219556|"     This is post-marketing observational study in which data on safety and effectiveness of     Xirtam H will be collected from routine clinical practice. The study objectives are to     investigate the effect of Xirtam-H on blood pressure and achievement of target blood pressure     as well as safety and satisfaction of treatment. All hypertensive patients (Blood pressure >     140/90 mmHg) where investigator feels that addition of Xirtam H would be beneficial to     patients will be included in non interventional study. The routine investigation suggested by     the attending physician will be done in patients of hypertension. No additional investigation     will be done for the study purpose. The patient not controlled on existing treatment and     prescribed Xirtam H will be included in study after taking the informed consent. The patient     will be followed up for 2-follow up visit each after 6 weeks. The physical examination,     routine investigation, blood pressure measures will be done and the data will be entered in     the CRF as mentioned in CRF in each visit. The study is planned to be carried out in 9604     patients from around 300 - 350 trial sites in India.   "
157701|NCT01219478|"     Purpose: To investigate the relationship between retinal thickness (RT) and metabolic risks     (MRs) in patients without retinal lesion.      Methods: Fifty-two patients over 60 y/o were divided into four groups according to their MRs     of hypertension, hyperlipidemia or hyperglyceremia. After complete ophthalmic examination,     optical coherence tomography was performed to measure RT.   "
157702|NCT01219465|"     The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of     treatment for initial type 1 diabetes is safe and effective.   "
157703|NCT01219452|"     The main aim of the study is to determine whether intramuscular injection of umbilical cord     mesenchymal stem cells can improve the ventricular function of children with idiopathic     dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible     mechanism of the improvement of ventricular function in children with IDCM and 2) to evaluate     the safety of intramuscular injection of umbilical cord mesenchymal stem cell.   "
157704|NCT01219439|"     The researchers propose to investigate the causes, incidence, and time-related events of     chromosomal and physiologic abnormalities as they relate to patient diagnosis, fertility     drugs utilized, and in vitro laboratory culture conditions.   "
157705|NCT01219426|"     This study is divided into two stages. In the first stage, students from the University of     Nantes completed the two assessment tools of gambling related cognitions (GABS : Gambling     Attitudes and Beliefs Survey ; GRCS : Gambling Related Cognitions Scale), and a reference     tool for gambling problem severity (SOGS : South Oaks Gambling Screen). In the second stage,     consecutive pathological gamblers seeking treatment at the University Hospital of Nantes     completed the three questionnaires. Only questionnaires from participants who reported     gambling at least one time in the past year were kept for analyses.Responses of students     gamblers and pathological gamblers presenting for treatment have been compiled for     analysis.The main objective of the study is to validate the French adaptations of the GABS     and the GRCS, and to explore their psychometric properties and structures.   "
157706|NCT01219413|"     To evaluate the proteinuria lowering efficacy as well as tolerability and safety of the renin     inhibitor aliskiren compared with that of placebo and angiotensin converting enzyme inhibitor     perindopril in patients with non-diabetic chronic renal disease.   "
157707|NCT01219400|"     The purpose of this study is to explore whether the novel therapy of type 2 diabetes,     vildagliptin, which inhibits dipeptidyl peptidase-4 (DPP-4), affects glucagon     counterregulation during hypoglycemia in insulin-treated patients with type 2 diabetes.     Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter     hypoglycemia is induced under standardized conditions, and the glucagon response is     determined, and compared to that after a month of placebo treatment.   "
157708|NCT01219387|"     The present study is designed to evaluate the basal serum levels of anti-mullerian hormone     (AMH) and inhibin B as early predictors of ovarian response, implantation rate, and pregnancy     rate in women 38 years old or older that are undergoing an IVF cycle.   "
157709|NCT01219374|"     To explore the attitudes and reactions of ovum donors prospectively after ovum donation and     to follow their medical histories.   "
157711|NCT01219348|"     Title: IDO peptid vaccination in combination with immune stimulating agent Aldara and the     adjuvant Montanide, for treatment of patients with locally advanced or metastatic non     small-cell lung cancer. A first-in-man phase I trial.      Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy targeting     the immune inhibiting enzyme, IDO to investigate the potential of vaccination against IDO as     a possible anticancer target.   "
157712|NCT01219335|"     Use of excess materials generally discarded in the process of undergoing IVF treatment to     further develop and validate laboratory techniques.   "
157713|NCT01219322|"     Extravasation is an unintentional injection or leakage of fluids in the perivascular or     subcutaneous space. Extravasation can be associated with tissue injury with various level of     severity and long term consequences. Currently the confirmation of intravenous location of     the Intravenous (IV) catheter requires close observation of the insertion site with     sufficient infiltration in the perivascular area to allow detection of swelling,     discoloration and discomfort. Under Anesthesia direct observation is frequently prohibited.     IV sodium bicarbonate (SB) is used frequently to treat different metabolic conditions and is     known to cause a temporary elevation of exhaled carbon dioxide. This study aim is to evaluate     the safety and efficacy of intravenous SB as a detector of intravenous placement of an IV     line in anesthetized patients.      Patients and Methods: The study has three parts, in part 1, the safety of subcutaneous     injection of sodium bicarbonate was evaluated in 6 rats. In each animal the macroscopic and     microscopic effects were evaluated and a safe dilution was determined. In the second part of     the study the investigators will evaluated the efficacy of IV diluted SB to detect the proper     location of IV catheters. 20 adult patients age 20 to 50 years will be enrolled. Patients all     under general anesthesia with standard controlled ventilation via endotracheal tube. The     correct placement of IV catheter will be confirmed by easy aspiration of blood from newly     placed IV catheter. In each patient a bolus of 50 cc of 0.5 meq/cc SB or volume equivalent of     normal saline will be injected in random order. The data collection will include patient's     demographics, the presence or absence of an increase in the expired end-tidal carbon dioxide,     onset and peak changes of end-tidal carbon dioxide as well as the hemodynamic changes after     each injection.   "
157714|NCT01219309|"     Objective: To assess whether supplementation with Omega 3/6 fatty acids (eye q®) was     effective in the treatment of ADHD and its diagnostic subtypes and comorbid conditions, in     children and adolescents.      Method: Randomized placebo-controlled one-way crossover trial with 75 children and     adolescents aged 8-18 years receiving Omega 3/6 or placebo for three months followed by 3     months with Omega 3/6 for all. ADHD symptoms were measured with the investigator-rated ADHD     Rating Scale-IV-Parent Version and the Clinical Global Impression (CGI) scale of symptom     severity and impairment.   "
157715|NCT01219296|"     Data collection and comparison of relationships between patient demographics, stimulation     protocols and outcomes, retrieval and transfer outcomes, number and quality of oocytes and     embryos retrieved and transferred, pregnancy rates and pregnancy outcomes.   "
157716|NCT01219283|"     The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis     (PGD) increases implantation and delivery rates in couples attempting to conceive through in     vitro fertilization (IVF).   "
157717|NCT01219270|"     Osmolality of contrast media can be resulted in translocational hyponatremia after     percutaneous coronary intervention.   "
157731|NCT01219088|"     Falls are a common problem in elderly patients resulting fractured femur, which require early     operation. Adequate postoperative pain control will provide good recovery. The investigators     will compare the efficacy of postoperative pain control among intrathecal morphine, femoral     nerve block, and periarticular infiltration with bupivacaine in patients undergone     intramedullary hip screw under spinal anesthesia.   "
157718|NCT01219257|"     Patients with spondylarthritis (SpA) (including ankylosing spondylitis, psoriatic arthritis,     arthritis as part of inflammatory bowel disease and reactive arthritis) have axial     involvement (the spine) as well as peripheral inflammation in joints and entheses (where the     tendons and ligaments are anchored to the bone). Patients with high disease activity of SpA     may need biological treatment (anti-TNF alpha), which are very expensive medications. Thus it     is necessary to have a sensitive method for assessing the response to treatment.     Ultrasonography (US) is a validated and reliable method for assessing disease activity in     joints and tendons, and may be used to follow the treatment response.      The present study will include patients with SpA starting on anti-TNF alpha treatment (as     first biologic medication or when switching to a new biologic treatment). The study is an     extension of the ongoing NORDMARD study (Norwegian longitudinal observational study of     arthritic patients starting disease-modifying treatment). The patients will be examined by     use of US of 38 joints and 14 entheses at baseline and after 3, 6 and 12 months.      The objectives are to explore US as a method to assess peripheral inflammatory activity for     evaluation of response to medication as well as to compare the US pathology with clinical and     laboratory findings.   "
157719|NCT01219244|"     The study will investigate whether dietary modification could provide positive effects on     brain functions in elderly people with mild cognitive impairment.   "
157720|NCT01219231|"     The researchers will investigate whether exercise could provide positive effects on general     brain functions in elderly people with impaired glucose tolerance.   "
157721|NCT01219218|"     Low intensity shockwaves have been proven in animal studies to induce local growth of new     blood vessels from existing ones.      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients     with refractory angina not amenable to revascularization with angioplasty or bypass surgery.   "
157722|NCT01219205|"     Although it is important in the clinical management to classify BRVO into subtypes based on     the location of the occlusion (major or macular), few studies have provided such     information[8,9]. The aim of this study was to evaluate the outcome of patients with macular     edema due to Branch retinal vein occlusion who were treated with intravitreal bevacizumab     injection and to determine the concentrations of cytokines in the aqueous humor according to     the site of the occlusion.   "
157723|NCT01219192|"     The purpose of this study is to evaluate the safety and tolerability and determine the     recommended dosing for the treatment in patients with advanced pancreatic cancer after     fist-line Gemcitabine treatment failure.   "
157724|NCT01219179|"     The improved survival rate of extremely low birth weight(ELBW)infants has resulted in new     fluid and electrolyte problems that have not been encountered previously,in particular     electrolyte imbalance. ELBW infants are especially vulnerable to hypernatremia(serum sodium     value >150 mEq/L). Hypernatremia may be due to rapid dehydration or excessive administration     of intravenous fluids(IV)that contain sodium. The current treatment modality for     hypernatremia is to increase IV fluids above daily requirements.Enteral sterile water     feeds(ESWF)are theorized as an endogenous source of fluids that may decrease elevated     electrolytes such as sodium and potassium in premature infants. By giving ESWF to decrease     elevated electrolytes, there would be less need for large volumes of IVF that contribute to     the co-morbidities of prematurity: bronchopulmonary dysplasia (BPD),intraventricular     hemorrhage(IVH)and patent ductus arteriosus(PDA).      The purpose of this proposed study is to determine whether enteral sterile water feedings is     effective in decreasing the incidence, duration and severity of hypernatremia in ELBW     infants.   "
157726|NCT01219153|"     The aim of this randomized controlled trial is to compare the efficacy of extended high dose     letrozole regimen (5 mg /day for the first 5 days of cycle and 2.5 mg/day for the subsequent     3 days ) with short low dose letrozole regimen (2,5 mg/day from cycle day 3 to 7 ) as an     adjuvant to GnRH antagonist protocol in the management of patients with poor ovarian response     undergoing IVF-ET.   "
157727|NCT01219140|"     Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate     extract capsules will produce statistically significant changes in biomarkers for bone     resorption and formation when compared to subjects receiving placebo.   "
157728|NCT01219127|"     Management of chronic diabetic foot skin ulcers require multidisciplinary approaches     including diabetic control, wound care, antibiotic, shoe wear off-loading, and surgery in     selected cases. The results are inconsistent and irregular, and most studies reported     unsatisfactory results. Many adjunctive therapies are implemented in the care of chronic     diabetic foot ulcers including hyperbaric oxygen therapy (HBO), ultrasound, recombinant human     platelet-derived growth factor-BB (rPDGF-BB), vacuum assisted wound closure (VAWC) and     acellular matrix. HBO is the most commonly utilized at the investigators institution. Mixed     results of HBO in chronic diabetic foot ulcers are reported. Several studies reported that     the beneficial effects of HBO, but none showed universal success. Therefore, the development     of a new effective method of treatment for chronic diabetic ulcers is extremely valuable.     Extracorporeal shockwave therapy (ESWT) acts as mechanotransduction that produces the     therapeutic benefits through complex biological pathways including neovascularization and     tissue regeneration. ESWT also showed bacteriostatic effects in experiments. Some studies     reported the effectiveness of ESWT in acute and chronic soft tissue wounds. Others reported     effectiveness of ESWT in chronic ulcers with 50% completely healed with 6 sessions of     treatment. With this background, it appears that ESWT may be effective in the treatment of     chronic diabetic foot ulcers. The purpose of this study is to evaluate the efficacy of ESWT     in chronic foot ulcers, and to compared with that treated with HBO, and to study the     molecular and blood flow perfusion before and after ESWT.   "
157729|NCT01219114|"     The purpose of this study is to monitor the safety and efficacy of CUBICIN under conditions     of actual use in patients who are diagnosed with complicated Skin and Skin Structure     infection (cSSI) or Staphylococcus aureus bacteria including right-sided endocarditis and are     prescribed CUBICIN by their physician.   "
157730|NCT01219101|"     According to the studies CC is successful at inducing ovulation in 50%-75% of cases, but only     30-40% becomes pregnant. The difference has been attributed to a negative action of clomifen     citrate(CC) in the form of prolonged antiestrogenic effects on endometrial receptivity. For     avoiding of these negative effects, giving ethinyl estradiol in sufficient dosages may be     effective. The purpose of this study is comparing pregnancy rates after IUI in women who use     CC alone and those who use CC in combination with ethinyl estradiol   "
157732|NCT01219075|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of soy isoflavones supplements may prevent or treat early stage breast cancer. PURPOSE: This     clinical trial studies soy isoflavones supplementation in treating women at high risk for or     with breast cancer.   "
157733|NCT01219062|"     Falls are a common problem in elderly people which they have to receive the operation.     Hemiarthroplasty is one of the common orthopedics operations. The prompt operation and good     pain control will provide the good recovery and outcome. The investigators compare the     efficacy of postoperative pain control between Intrathecal morphine 0.1 milligrams (mg.) with     the local infiltration of 0.25% Bupivacaine for 20 milliliters (ml.) in patients received hip     hemiarthroplasty under spinal anesthesia.   "
157734|NCT01219049|"     Patients in the study, who have a diagnosis of fibromyalgia, will be randomly assigned to     take the amino acid L-tyrosine or placebo (blank pill) for 3 weeks. They will fill out     questionnaires about their symptoms and see if they have any improvement. The investigators     hypothesis is that taking tyrosine will help alleviate the symptoms of fibromyalgia.   "
157735|NCT01219036|"     Asthma usually responds to standard doses of inhaled steroids with or without additional     therapies to control their symptoms. However, approximately 5-10% do not respond to this     treatment strategy and are referred to as having difficult asthma. Evidence shows that this     poor response is not always related to asthma severity with non-adherence to treatment being     a common underlying problem, in 35% of subjects. Recognising non-adherence in the clinic is     problematic as there is no straightforward objective test to identify it.      Patients attending an asthma clinic whose symptoms are not controlled by standard treatment     will be assessed for airway inflammation using fractional exhaled nitric oxide, and sputum     analysis. These subjects will be observed taking their medication to determine if this     reduces their level of airway inflammation. Prescription records will be used to ascertain if     this test distinguishes those who are non-adherent with their treatment from those adults who     have severe asthma.      Identifying patients who are non-adherent to treatment will allow an appropriate change in     management and enable alternative strategies to be developed to tackle non-adherence in this     population. Distinguishing patients who are adherent to treatment but have therapy resistant     disease would significantly improve treatment effectiveness in this group by allowing these     patients to be suitably targeted with expensive novel therapies such as Omalizumab.   "
157756|NCT01218763|"     This clinical investigation is a prospective, non-randomized, multi-center pivotal trial.      This trial aims to validate the automatic detection features provided by the external     long-duration SpiderFlash-t™ Event recorder coupled with its analyser EventScope™, and to     assess the performances of the Mode Switch function provided by Sorin Group Implantable     Cardioverter-Defibrillators (ICDs).      This trial is being performed first in order to demonstrate the ventricular tachycardia (VT)/     ventricular fibrillation (VF) sensitivity of the automatic VT/VF detection function of the     EventScope™ software.      Patients will be implanted with an ICD from Sorin Group, with PARAD+ arrhythmia detection     enabled and Mode Switch (MS) algorithms activated in all patients.      Arrhythmic events will be documented over a period of 6 to 8 weeks for each patient.   "
157736|NCT01219023|"     Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysethesia (PPE), occurs in a     25%-50% of patients treated with several commonly used anti-cancer drugs including     capecitabine and sunitinib. These drugs are known to improve survival in many cancers,     including cancers of the colon, stomach, liver, breast, kidney, and GI stromal tumors (GIST).     Worldwide, over 400,000 patients per year are treated with one of these agents. HFS involves     skin changes, such as swelling, peeling, and blistering of the palms and soles, which is     often painful and debilitating. As a result, HFS-related symptoms can frequently lead to dose     reduction and/or discontinuation of otherwise effective anti-cancer treatment. There is no     treatment for HFS other than dose reduction or stopping treatment. This proposal could     quickly lead to treatments to prevent and/or treat HFS and help patients avoid debilitating     side effects while continuing otherwise effective treatments for their cancer.   "
157737|NCT01219010|"     The purpose of this study is to determine if siltuximab has an effect on the heart function     measured by ECG recordings and more specifically to determine if siltuximab has an effect on     the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS),     Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM). The study will also     look to see if siltuximab may be useful in treating patients with MGUS, SMM or IMM.   "
157738|NCT01218997|"     This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of     repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to     adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual     of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1     ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of     VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.   "
157739|NCT01218984|"     This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults     to assess the presence, duration, and degree of opiate blockade as well as the safety and     tolerability of Medisorb® naltrexone (VIVITROL®). Subjects were randomized in a 1:1:1 ratio     to receive a single gluteal intramuscular (IM) injection of Medisorb naltrexone 75, 150, or     300 mg.   "
157740|NCT01218971|"     This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base     study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4     weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study     ALK21-003.   "
157741|NCT01218958|"     This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted     in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical     Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive     intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg,     placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg     (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.   "
157742|NCT01218945|"     The repair of large osseous defects remains still unsolved. Aim of this study is to isolate     and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore,     our research idea is to pre-engineer large synthetic bone grafts and study the     vascularization process in vivo.   "
157743|NCT01218932|"     This is a standard pharmacokinetic interaction study. Subjects will be randomized to be     either group A or B. Group A. Subjects will have 3 hospitalizations to complete. Each     hospitalization will be about 12-24 hours depends on each regimen. Subjects in A group who     receive regimen 1 of primaquine (PQ) on the first admission (visit 2) will receive regimen 2     of primaquine and chloroquine combination (PQ and CQ) on second admission (visit 3) after 1     week wash out period and will finish with regimen 3 of Chloroquine (CQ) on the third     admission (visit 4) after 8 weeks wash out period.      Subjects in B group who receive regimen 1 of primaquine (PQ) will receive regimen 2 of     chloroquine (CQ) on second admission (visit 3) after 1 week wash out period and regimen 3 of     primaquine and chloroquine combination (PQ and CQ)on third admission(visit 4) with 8 week     wash out period in between.   "
157744|NCT01218919|"     The objective of this study is to evaluate the effectiveness of a rechargeable Deep Brain     Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced,     levodopa-responsive Parkinson's disease that are not adequately controlled with medication.      This is the first observational study for the use of the BRIO™ rechargeable constant current     device, using a lead with an active electrode tip for deep brain stimulation in Parkinson     subjects. The current study was designed to conform to normal medical practices, taking into     consideration the current day economic constraints, while assessing the best set of     circumstances for the successful sustained reduction of some of the symptoms of advanced,     levodopa-responsive Parkinson's disease that are not adequately controlled with medication.   "
157745|NCT01218906|"     The purpose of this study is to detect acute febrile episodes and dengue infection in five     Asian countries, to assess dengue seroprevalence, and to assess surveillance infrastructure     at investigational sites in anticipation of a Phase 3 efficacy trial of a vaccine to prevent     dengue infection.      The primary objectives are:        -  To identify acute febrile episodes among the cohort in order to detect the presence of          dengue infection.        -  To develop operational infrastructure for potential Phase III dengue efficacy trial          sites.        -  To describe the dengue seroprevalence among the cohort at baseline and at the end of the          study.   "
157757|NCT01218750|"     The purpose of this study is to evaluate the safety end efficacy of combined     phakoemulsification and vitrectomy with retinal endophotocoagulation and intraoperative use     of bevacizumab in patients with diffuse diabetic macular edema (DDME), to determine the     possible preoperative and intraoperative factors that might influence surgical outcomes.   "
157758|NCT01218737|"     The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and     1.0% prednisolone acetate association in eye drops in the prevention of infection and     inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the     efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0%     prednisolone acetate as isolated eye drops formulations. The study treatment is randomized,     double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days     of study treatment administration after the ocular surgery is performed. Candidates for the     study are patients with indication for ocular refractive surgery (Lasik) for correction of     visual acuity.   "
157746|NCT01218893|"     Malaria is one of the major infectious diseases in the world with a tremendous impact on the     quality of life significantly contributing to the ongoing poverty in endemic countries. It     causes almost one million deaths per year, the majority of which are children under the age     of five. The malaria parasite enters the human body through the skin, by the bite of an     infected mosquito. Subsequently, it invades the liver and develops and multiplies inside the     hepatocytes. After a week, the hepatocytes burst open and the parasites are released in the     blood stream, causing the clinical phase of the disease.      As a unique opportunity to study malaria immunology and efficacy of immunisation strategies,     a protocol has been developed in the past to conduct experimental human malaria infections     (EHMIs). EHMIs generally involve small groups of malaria-naïve volunteers infected via the     bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although potentially     serious or even lethal, P. falciparum malaria can be radically cured at the earliest stages     of blood infection where risks of complications are virtually absent.      The investigators have shown previously that healthy human volunteers can be protected from a     malaria mosquito (sporozoite) challenge by immunization with sporozoites (by mosquito bites)     under chloroquine prophylaxis (CPS immunization). However, it is unknown how many mosquito     bites are necessary to confer protection. Moreover, as all volunteers were protected in this     study, no correlates of protection could be established. For future development of vaccines     and understanding of protective immunity to malaria, it is important to investigate the     lowest dose of CPS immunization that confers 100% protection and to find correlates of     protection. Therefore, the present study aims to make the CPS immunization protocol more     sensitive by lowering the number of infected mosquito bites, in order to study the underlying     mechanisms of protection.   "
157747|NCT01218880|"     Phase I trail will be conducted to evaluate the safety of M2ES in combination with     gemcitabine in locally advanced or metastatic pancreatic cancer.   "
157748|NCT01218867|"     Background:      The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for     treating patients metastatic cancer that involves taking white blood cells from the patient,     growing them in the laboratory in large numbers, genetically modifying these specific cells     with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells     back to the patient. This type of therapy is called gene transfer. In this protocol, we are     modifying the patient s white blood cells with a retrovirus that has the gene for     anti-vascular endothelial growth factor receptor (VEGFR2) incorporated in the retrovirus.      Objectives:      - To determine a safe number of these cells to infuse and to see the safety and effectiveness     of cell therapy using anti-VEGFR2 gene modified tumor white blood cells to treat recurrent or     relapsed cancer.      Eligibility:      - Individuals greater than or equal to 18 years of age and less than or equal to 70 years of     age who have been diagnosed with metastatic cancer that has not responded to or has relapsed     after standard treatment.      Design:        -  Work up stage: Patients will be seen as an outpatient at the National Institutes of          Health (NIH) clinical Center and undergo a history and physical examination, scans,          x-rays, lab tests, and other tests as needed        -  Leukapheresis: If the patients meet all of the requirements for the study they will          undergo leukapheresis to obtain white blood cells to make the anti-VEGFR2 cells.          {Leukapheresis is a common procedure which removes only the white blood cells from the          patient.}        -  Treatment: Once their cells have grown the patients will be admitted to the hospital for          the conditioning chemotherapy, the anti-VEGFR2 cells and aldesleukin. They will stay in          the hospital for about4 weeks for the treatment.        -  Follow up: Patients will return to the clinic for a physical exam, review of side          effects, lab tests, and scans about every 1-3 months for the first year, and then every          6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up          to 2 days.   "
157785|NCT01218386|"     The present study is set up to evaluate the efficacy of a programmation by administration of     estrogen valerate during 6 or more consecutive days. In this prospective randomised trial, we     study the impact of administration of Progynova® during 6, 7,8 9 or 10 consecutive days     during the luteo-follicular transition period of the menstrual cycle.   "
157786|NCT01218373|"     The clinical evaluation of the HOMESWEETHOME project sets out to assess the long-term effects     of continuous assistance offered by the HOMESWEETHOME services to older people living     independently. The trial will test the hypothesis that while providing a level of safety     equivalent to or better than that enjoyed in older people‟s homes, there is a significant     positive effect on the quality of life (QoL) and the duration of independently living of     older people.   "
157749|NCT01218854|"     Background:      - Currently, standard procedures for biopsies that are guided by computed tomography (CT)     imaging involve CT scans and a computer program to plan and illustrate where the physician     will place the needle to obtain the required cells or tissue. Inserting the biopsy needle at     the planned angle is not an easy task, because the appropriate angle of insertion must be     estimated based on prior experience. Researchers are studying experimental techniques that     might provide better guidance about the right angle to insert the biopsy needle and thereby     improve the collection of the appropriate biopsy cells or tissue.      Objectives:      - To evaluate the effectiveness of two biopsy needle guidance methods in CT-guided tissue     biopsy.      Eligibility:      - Individuals at least 18 years of age who are scheduled to have CT-guided tissue biopsy.      Design:        -  Participants will have a tissue biopsy guided by CT scans and either a laser system or a          plastic block to illustrate the appropriate angle of insertion. The skin will be numbed          with anesthetic to minimize discomfort during the procedure.        -  Before inserting the biopsy needle, the study physician will hold the needle in place so          that a Food and Drug Administration-approved medical GPS (electromagnetic tracking)          system can measure the needle angle as it enters the tissue.        -  After the needle angle data has been collected, researchers will proceed with the actual          biopsy procedure as it would normally occur, using standard methods.        -  No additional treatment will be provided as part of this protocol.   "
157750|NCT01218841|"     Surgical trauma can lead to an intense inflammation and impairment of the capacity to fight     against infections. Fish oil is composed by substances called omega-3 fatty acids which have     anti-inflammatory effects. When infused through the vein as part of a nutritional treatment     of some surgical patients, fish oil have been shown to preserve some defense capabilities     against infections and to decrease postoperative release of inflammatory substances,     contributing to the shortening of length of hospital and intensive care unity (ICU) stay and     complications, mainly infectious complications. These reported benefits have been encouraging     the vein infusion of fish oil as a kind of medicine to contribute for the treatment of     surgical patients. In current study the investigators evaluated the effect of preoperative     infusion of pure fish oil in patients with gastrointestinal cancer (stomach and colon) on     their clinical outcomes. The hypothesis considered that preoperative infusion of fish oil,     not as part of nutritional therapy but as a medicine agent, can attenuates inflammation and     improves the capacity of surgical patients to fight against infections, improving their     treatment.   "
157751|NCT01218828|"     Using a randomized controlled trial design, two hydration protocols for the prevention of     contrast medium-induced nephropathy will be tested.   "
157752|NCT01218815|"     CORAMI trial is a prospective, international, multicenter randomized study which will be     performed in experienced invasive facility centres with 24/7 PCI (percutaneous coronary     intervention) duty and patient enrollment will continue for 18 months (October 2010 - March     2012).The aim of the study is to compare strategy of complete vs target lesion-only primary     PCI in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.   "
157753|NCT01218802|"     The hypothesis of this study is that 96 weeks of Rosuvastatin will be safe and effective in     decreasing cardiovascular risk and bone loss in the HIV+ population.   "
157754|NCT01218789|"     The purpose of this study is to evaluate the safety of a one year open-label treatment of     tasimelteon in male and female subjects with Non-24-Hour Sleep-Wake Disorder.   "
157755|NCT01218776|"     The International Registry of Acute Coronary Syndromes registry study in Transitional     Countries (ISACS-TC) is both a retrospective and prospective study which was designed in     order to obtain data of patients with acute coronary syndromes in countries with economy in     transition, and herewith control and optimize internationally guideline recommended therapies     in these countries Further study details as provided by the CINECA     http://isacs-ct.cineca.org/   "
157760|NCT01218711|"     Objective:      to compare the single dose bioavailability of Torrent's Losartan Potassium and     Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck & Co.,     Inc.      Study Design:      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects   "
157761|NCT01218698|"     Objective:      compare the single dose bioavailability of Torrent's Losartan Potassium Tablets 1 × 100 mg     and Cozaar® Tablets 1 × 100 mg of Merck & Co., Inc.      Study Design:      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects   "
157762|NCT01218685|"     The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted     vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised     disease, elderly and pregnants. The primary immunological endpoint is to analyze the     proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition     assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21     days after vaccination. Volunteers will be recruited based on inclusion and exclusion     criteria. Vaccine composition is: 15 micrograms of split inactivated virus     (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is     safe and immunogenic in the volunteers recruited.   "
157763|NCT01218672|"     The study will compare procedural and post procedural outcomes for photoselective     vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP). The     study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE     marked monopolar or bipolar loop TURP system for the treatment of benign prostatic     hyperplasia (BPH). The purpose of the study is to demonstrate that PVP is not inferior to     TURP.   "
157764|NCT01218659|"     Study to compare the efficacy and safety of AT1001 and enzyme replacement therapy (ERT) in     male and female patients with Fabry disease who are currently receiving ERT and who have     AT1001-responsive GLA mutations.   "
157787|NCT01218360|"     This is an observational study to determine the prevalence of moderate to severe Crohn's     disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a     standard clinical practice.   "
157788|NCT01218347|"     This study aimed to explore the influence of organic anion transporting polypeptide1B1     (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after     rosuvastatin administration.   "
158182|NCT01213199|"     The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the     treatment of atrophic acne scars.   "
157765|NCT01218646|"     The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the     licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the     investigational TIV containing the alternate B strain in adult subjects.      Primary Objective:        -  To demonstrate non-inferiority of antibody responses to QIV compared with licensed          2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the          alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the          four virus strains separately among subjects 65 years of age and older      Observational Objective:        -  To describe the safety profiles of TIV among subjects 18 years of age and older and QIV          in subjects 65 years and older, as assessed by solicited injection site and systemic          adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events          collected from 21 days post-vaccination, and adverse events of special interest and          serious adverse events (SAEs) collected from Visit 1 to Visit 2.   "
157766|NCT01218633|"     Multiple studies have examined the effect of endogenous GLP-1 secretions by using a     competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However,     the presence of an effect does not necessarily imply that this effect is due to the blockade     of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic     concentrations of Exendin may have effects of its own. To examine the effect of Exendin on     glucose metabolism the investigators propose a dose-response study to determine whether the     compound has effects in a dose-dependent fashion.   "
157767|NCT01218620|"     This randomized phase I trial studies the side effects and best dose of RO4929097 in treating     patients with advanced solid tumors. RO4929097 may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
157768|NCT01218607|"     Volume overload due to left-to-right shunting in patients with atrial septal defect type     secundum causes pulmonary vascular disease over a long period of time. Pulmonary vascular     resistance can be assessed non-invasively using bicycle stress echocardiography. By measuring     cardiac output and pulmonary artery pressures at different stages of exercise, a     pressure-output plot can be obtained. The slope of the pressure-output plot reflects     pulmonary vascular resistance. In patients undergoing ASD repair after the age of 40 years,     pulmonary vascular resistance was higher when compared to age-matched controls, indicating     the presence of mild pulmonary vascular disease. Bosentan has been shown to decrease     pulmonary vascular resistance.      The investigators hypothesize that in patients with an ASD type secundum, who underwent ASD     repair after the age of 40 years, administration of bosentan decreases pulmonary vascular     resistance as assessed by bicycle stress echocardiography.   "
157769|NCT01218594|"     To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy     (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).   "
157770|NCT01218581|"     To date, there is no uniform agreement on the most appropriate therapeutic methods for     managing women with uterine adenomyosis and/or adenomyoma who want to preserve their     fertility. Management with hormonal treatment that aims to reduce the proliferation of     endometrial cells is promising, but there is a paucity of well-designed studies to guide     treatment. There is a strong need to develop pharmacological agents that provide an efficient     outcome. Gonadotripn releasing hormone analogues (GnRHa) have been used in several studies,     to produce a constant hypoestrogenic state in a woman with adenomyosis which cause     amenorrhoea, control of pain and uterine shrinkage . Pure antiestrogens, however, may offer     some advantage in the treatment of adenomyosis and trials are required to assess its     usefulness. Leiomyoma and uterine volumes were successfully reduced by use of aromatase     inhibitors (AIs). Assuming aromatase production activity in the adenomyosis lesion, Kimura et     al, used GnRHa and an AI concomitantly for treatment of uterine adenomyosis. This lack of     information stimulated us to run this trial to compare the efficacy of aromatase inhibitor     vs. GnRHa in treating premenopausal women with uterine adenomyosis.   "
157798|NCT01218217|"     SQ109 was developed with the aim of shortening TB treatment and providing new drugs for     resistant TB. The drug has demonstrated efficacy in toxicology studies and an acceptable     safety profile in first-in-man studies. The objective of this study is to evaluate the     extended early bactericidal activity (EBA), safety, tolerability, and pharmacokinetics of     several doses of SQ109 with or without Rifampicin (RIF) for 14 days in adults with newly     diagnosed, uncomplicated, smear positive, pulmonary TB.   "
157771|NCT01218568|"     The study will be double blind with respect to rifaximin, and randomization will be performed     using tables of computer-generated random numbers. All subjects will be followed up till the     recovery of HE (primary end point) or 10 days whichever is earlier. In the Lactulose group     (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient     passes 2-3 semisoft stools per day along with placebo . In the lactulose plus rifaximin group     (group B) patients will receive cap rifaximin 400mg three times a day along with lactulose.     Primary endpoints will be recovery of overt HE patients who will not recover from HE after 10     days will be continued on the same treatment. Total duration of the study is 1 year.   "
157772|NCT01218555|"     The purpose of this study is to study the combination of two anticancer drugs, everolimus     (RAD001) and lenalidomide in patients whose cancer is no longer responding to standard     treatment or patients who are unable to tolerate the standard treatment for their cancer.   "
157789|NCT01218334|"     The proposed study is a two-arm, randomized, single-blinded, cross-over Phase III clinical     trial in which patients in 3 distinct clinical scenarios will receive the 12LEG, followed by     the standard ECG, or vice-versa. Each participant will then apply the Hand ECG themselves.     The 3 clinical scenarios will be: 1. patients at preoperative assessment for elective cardiac     catheterization or electrophysiology procedures; 2. patients coming for outpatient cardiology     appointments; 3. Inpatients admitted with a cardiac diagnosis.      The electrophysiologists reviewing ECGs will be blinded to the equipment utilized to obtain     the ECG.   "
157790|NCT01218321|"     This study is based on the hypothesis that antiepileptic drugs (other than Valproic acid)     have an effect on the mitochondrial oxidative phosphorylation.      The objective of this study is to evaluate this effect in an accessible tissue—human     peripheral white blood cells.   "
157791|NCT01218308|"     This study is designed to test the efficacy of an investigational influenza vaccine, in     children compared to Havrix®, a licensed Hepatitis A virus vaccine.      This study will also evaluate the immunogenicity and safety of the investigational vaccine.   "
157773|NCT01218542|"     Brain metastases are the most common adult intracranial tumor, occurring in approximately 10%     to 30% of adult cancer patients, and represent an important cause of morbidity and mortality.     The most widely used treatment for patients with multiple brain metastases is whole brain     radiation therapy (WBRT). The use of WBRT after resection or stereotactic radiosurgery (SRS)     has been proven to be effective in terms of improving local control of brain metastases.      RapidArc (RA) (Varian Medical Systems, Palo Alto, CA) is a new method of delivering radiation     that uses arcs to deliver highly conformal intensity modulated three dimensional dose     distributions. The purpose of this investigation is to evaluate an alternative strategy for     giving WBRT with highly focal boost to gross visible lesions in patients with brain     metastasis.      Given the limitations of the SRS boost technique, the purpose of our investigation is to     evaluate an alternative strategy for giving WBRT with highly focal boost to gross visible     lesions in patients with brain metastasis. In this study, we plan to assess the tolerability     of using volumetric modulated arc therapy (RapidArc) on patients with brain metastasis to     simultaneously treat the entire brain with a concomitant focal boost to grossly identified     lesions on MRI scan to try to improve local control and reduce neurocognitive toxicities.      This previous version of this study was a phase I dose escalation trial giving 25 Gy in 10     fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10     fractions to gross brain metastatic disease. Prior to this, patients were enrolled onto one     of two cohorts with whole brain dose of 30 Gy in 10 fractions with SIB to total of 45 Gy in     10 fractions to gross brain metastatic disease or whole brain dose of 37.5 Gy in 15 fractions     with SIB to total of 52.5 Gy in 15 fractions to gross brain metastatic disease. A total of 12     patients have been previously enrolled on this trial. No patients have experienced a dose     limiting toxicity (grade 3 or above) at least possibly due to study therapy. Also, no     patients experienced local brain failure/progression at a site of treated metastatic brain     disease. Based on this, we no longer feel that dose escalation to the gross brain disease is     warranted and would proceed with a single arm pilot study treating patients with 25 Gy in 10     fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10     fractions to gross brain metastatic disease.   "
157774|NCT01218529|"     This phase II open-label study will be performed to evaluate the response rate of brain     metastases from lung and breast tumors under treatment with WBRT and lapatinib.   "
157775|NCT01218516|"     The primary objective of this study is to compare the effect of farletuzumab versus placebo     in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent     (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on     investigator-assessed progression free survival (PFS) as determined by Response Evaluation     Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new     occurrence of positive fluid cytology) in chemotherapynaive participants with folate     receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.   "
157776|NCT01218503|"     This study is designed to determine whether obese, normal weight, and successful weight loss     maintainers differ in their food choice decision-making and/or executive function, and     whether participation in a behavioral weight loss program leads to neural and/or behavioral     changes. The investigators will examine behavioral performance on several tasks involving     decision-making and self-control in conjunction with brain imaging data acquired during a     food-choice decision-making task. Participants enrolled in the behavioral weight loss program     will also be assessed following the treatment.   "
157777|NCT01218490|"     It is a multicenter randomized trial of superior cleaning compared the absence of dissection     in stage III patients with optimal surgical resection without retroperitoneal lymph node     palpable.   "
157778|NCT01218477|"     The purpose of the study is to determine the safety and tolerability of the combination of     BMS-833923 plus dasatinib in patients with chronic myeloid leukemia.   "
157779|NCT01218464|"     Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. and     liver transplantation is the only available therapeutic option for patients suffering with     this condition. However, lack of donors, surgical complications, rejection, and high cost are     serious problems. Previous study showed that bone marrow derived mesenchymal stem cells     (BM-MSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver     failure and contribute to liver regeneration. In this study, the patients with LF will     undergo administration of human umbilical cord mesenchymal stem cells (UC-MSCs) via     peripheral vein transfusion to evaluate the safty and efficacy of UC-MSCs treatment for these     patients.   "
157780|NCT01218451|"     The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C     in infants (at either 4 or 6 months of age), as determined by immune response.   "
157781|NCT01218438|"     The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation     for the treatment of patients with primary immunodeficiency diseases (PIDD).   "
157782|NCT01218425|"     A recent study at our lab showed increased episodic memory consolidation and response     readiness after treatment with methylphenidate in healthy volunteers. The investigators seek     to replicate and extend these findings. Furthermore the pharmacological specificity of these     effects will be studied. Since methylphenidate has an effect on two neurotransmitters,     dopamine and noradrenaline, either could be responsible for the observed effects. In order to     explore the dopaminergic contribution to this effect, the study proposed here includes not     only methylphenidate but also levodopa/carbidopa, which only affects dopamine and not     noradrenaline.      In this study, 20 healthy males and females between 18 and 45 years of age will participate.     They will be recruited via advertisements at Maastricht University and in local newspapers.      Participants will be treated once with methylphenidate, once with levodopa/carbidopa and once     with placebo. All medications will be administered orally with a capsule.      It is hypothesized that methylphenidate and levodopa/carbidopa will both enhance episodic     memory consolidation and improve response readiness   "
157799|NCT01218204|"     This study investigates the safety, pharmacokinetics and effects of GSK1292263 when taken     alone or when co-dosed with atorvastatin to subjects with dyslipidemia.   "
157800|NCT01218191|"     The aim of this study is to describe acute neurocardiogenic injury after subarachnoid     hemorrhage assessed with cardiac 123I-MIBG scintigraphy and 18F-FDG PET/CT during the first     week and the first six months after SAH.      The study hypothesis is that the evolution of the cardiac disturbances follows the clinical     evolution.   "
157783|NCT01218412|"     The specific aims of the proposed study are:        -  1. To determine if web-based Motivational Interviewing (MI) is effective, compared to an          informational web-based comparison group, in enhancing physical activity (PA)          participation; and        -  2. To assess the mechanisms by which web-based MI enhances PA through changes in          targeted cognitive mediators.      The specific hypotheses of the study include that:        -  Hypothesis 1: Web-based MI will increase PA;        -  Hypothesis 2: Web-based MI will lead to stage progression in the direction of increased          readiness to participate in PA;        -  Hypothesis 3: Web-based MI will influence theoretically identified cognitive variables;        -  Hypothesis 4: Cognitive variables will mediate increases in PA participation.   "
157784|NCT01218399|"     This is an investigator-initiated study in which Dr. Nadeau wrote the protocol and received     funding from an Astra Zeneca grant to direct, perform, and monitor the study on her own with     Stanford staff. We hypothesize that the budesonide/formoterol combination improves the     efficacy of budesonide alone.   "
157792|NCT01218295|"     Many studies suggest that inspiratory muscles training by means of normocapnic hyperpnea     improves exercise tolerance in healthy subjects. No information is available about the use of     this training in COPD patients even if other methods (such as threshold loading and resistive     loading) have been shown to be effective in terms of Inspiratory Muscle Function,     Health-Related Quality of Life and Exercise Tolerance.      This study is designed to evaluate the effects of normocapnic hyperventilation by means of     Spirotiger®, an instrument training the respiratory muscles, avoiding hypocapnia (using the     methodology of isocapnic hyperpnoea)in COPD patients.   "
157793|NCT01218282|"     Exercise training is the key component of respiratory rehabilitation.The success of long-term     program resides in the integration between exercise prescription and patients'compliance with     home training. This can be difficult for patients, especially in terms of understanding the     exercise intensity.      This study is designed to evaluate different methods of exercise training at home, to help     understanding and maintaining the walking intensity in COPD patients. Outcome: exercise     performance, daily physical activity and respiratory function.   "
157794|NCT01218269|"     This study will assess the nitinol U-clip as an alternative to conventional microsurgical     suture for arterial anastomoses in free tissue transfer.   "
157795|NCT01218256|"     Skeletal muscle accounts for up to 40% of the total body weight and is responsible for     approximately 75% of the whole body insulin-stimulated glucose uptake. Resistance training     has been shown to improve insulin-stimulated glucose uptake in patients with T2DM. Therefore     the investigators aim to compose the effects of 2 different resistance training protocols in     combination with aerobic endurance training (AET) on muscle strength, muscle mass and     glycemic control in type 2 diabetes mellitus patients (T2DM).      The investigators aim to perform an 8 week randomized controlled training intervention in 32     T2DM patients. Patients will be randomly assigned to AET (cycle ergometer, 60-70% of heart     rate reserve) combined with hypertrophy resistance training (HRT, n=16, 2 sets, 10-12     repetitions, 70% of the one-repetition maximum) or with endurance resistance training (ERT,     n=16, 2 sets, 25-30 repetitions, 40% of the one-repetition maximum). Body composition, blood     analyses, physical work capacity and muscle strength will be measured pre- and     post-intervention.   "
157796|NCT01218243|"     To evaluate efficacy of BL33 for mild and moderate benign prostatic hyperplasia(BPH).There     are trials showing that electroacupuncture on BL33 for mild and moderate BPH is more     effective than terazosin. It could reduce the International Prostate Syndrome Score (IPSS) by     6.68±2.84(39.79%),lower urinary symptoms bother of score(BS) and bladder residual urine, and     increase maximum urinary flow rate.But the efficacy of BL33 has not been studied. The     objective of this study is to evaluate efficacy of BL32 for mild and moderate BPH by     comparison with non-acupoint group.   "
157797|NCT01218230|"     Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic     myopia   "
173630|NCT00116545|"     The purpose of this study is to determine if troglitazone reduces the progression of early     preintrusive carotid atherosclerosis in insulin-requiring diabetes patients.   "
157801|NCT01218178|"     Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and     therapeutic procedures in interventional cardiology, especially in the acute setting of     primary PCI. The investigators will test the efficacy of sodium bicarbonate (NaHCO3) and     N-acetylcysteine (NAC) on the prevention of acute events and CIN in patients with acute     myocardial infarction.   "
157802|NCT01218165|"     Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part     of the aging process, including immunosenescence, is explained by an imbalance between     inflammatory and anti-inflammatory networks, wich results in the low grade chronic     pro-inflammatory status termed inflammaging. It can contribute to a number of age-related     chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis).     Prevention or delay in onset of chronic diseases can potentially benefit a large segment of     the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade     inflammation through improvement of the gut barrier function and gut microbiota composition     in elderly people with low-grade inflammation.   "
157803|NCT01218152|"     Neurofibromatosis type 1 (NF1) is a frequent autosomal dominant disorder, caused by     heterozygous mutations of the NF1 tumor suppressor gene (chr.17q11.2). One of the main     clinical features is the development of benign and malignant tumors. The most common benign     tumors in these patients are tumors of the peripheral nerve, named neurofibromas. Every NF1     patient has a life time risk of 8-13% to develop a malignant peripheral nerve sheath tumor     (MPNST) starting from a pre-existing neurofibroma. MPNSTs lead to a bad prognosis for the     patient, with an overall five-year survival of less than 25%. Complete resection is the     standard treatment, but this is often difficult due to the size of the tumors and the     location on important nerves, moreover the tumor is frequently metastatic at the time of     diagnosis. For MPNSTs, like for other cancers, the extent and the spread of the disease at     time of diagnosis is an important factor in determining treatment outcome. In this regard,     the analysis of tumor derived cell-free circulating DNA in plasma of NF1 patients would open     up the possibility to diagnose and monitor the development and progression of MPNSTs using a     small blood sample. In cooperation with P. Schöffski (UZLeuven), we plan to collect blood     samples from cancer patients to optimize the DNA extraction procedure starting from plasma     samples. It is known that patients with cancer have a higher amount of free circulating DNA     in plasma than individuals without cancer and therefore we want to optimize the DNA     extraction procedure on plasma from patients with cancer. In the meantime, matching MPNST and     plasma samples from NF1 patients will be collected and sent to us from the University of     Eppendorf (Victor Mautner) to optimize the array CGH protocol for the detection of copy     number changes in plasma DNA of NF1 patients with MPNSTs.   "
157864|NCT01217593|"     The purpose of this study is to compare ultrasound and predetermined distance techniques for     finding the paravertebral space to inject the local anesthetic (numbing medicine) when you     are given anesthesia for surgery. The paravertebral space is located on either side of the     spinal cord and contains the nerves that provide sensation to the chest wall. The     predetermined distance technique is a series of measurements taken to determine the location     of the paravertebral space where the local anesthetic is injected. The ultrasound technique     uses direct visualization of the local anesthetic being placed in the paravertebral space.     This type of anesthesia has many benefits including decreasing your pain after breast     surgery.   "
157804|NCT01218139|"     Neurofibromatosis type 1 (NF1) is a frequent, autosomal dominant disorder caused by     heterozygous mutations (intragenic or microdeletion) of the NF1 tumor suppressor gene     (chr.17q11.2). One of the clinical features is the development of benign and malignant     tumors. The most common benign tumors in these patients are tumors of the peripheral nerve     sheath, named neurofibromas (cutaneous, subcutaneous and plexiform). Every NF1 patient has a     life time risk of 8 to 13% of developing a malignant peripheral nerve sheath tumor (MPNST)     out of a pre-existing neurofibroma. In patients with a NF1 microdeletion (5% of NF1     patients), this risk is even twice as high compared to patients with an intragenic mutation.     MPNSTs lead to a bad prognosis for the patient, with an overall five-year survival of less     than 25%. To know more about the development and progression of these tumors, they will be     screened by microarray comparative genome hybridization (Leuven) and full exome sequencing     (Leuven). Further experiments will be done in cooperation (bidirectional) with the foreign     labs of Victor Mautner (Germany), André Bernards (USA), Karen Cichowski (USA) and Yuan Zhu     (USA).      For all these experiments, we will make use of tumoral rest material removed from NF1     patients.   "
157805|NCT01218126|"     Randomised, double-blind, parallel-group, multi-centre study evaluating three doses of     losmapimod (2.5mg, 7.5 mg and 15 mg) twice daily (BID) versus placebo on exercise tolerance.     Eligible subjects will be randomised to treatment after a one-week run-in period. The     duration of the treatment period is 24 weeks. An estimated 1000 subjects will be screened to     reach the target enrolment of approximately 600 randomised subjects.   "
157806|NCT01218113|"     This study is designed to determine whether administration of the GSK Biologicals HIV vaccine     732462 can lead to a reduction in viral load, and impact on the course of human     immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet     started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the     initiation of treatment.   "
157807|NCT01218100|"     This study will evaluate the safety and efficacy of first-line treatment with a free     combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2     diastolic hypertension (DBP>= 100 mmHg).   "
157808|NCT01218087|"     Many hospitalized infants can develop a flattening of the back or sides of their head. This     condition develops gradually when an infant's head rests on a firm or semi-firm surface for a     prolonged period of time. Premature infants are more likely to have a positional head shape     deformity because they may spend longer periods of time in a crib. Infants participating in     this study will be randomly assigned to either standard treatment, which is a moldable     positioner device, or to a cranial cup device and moldable positioner for positioning. The     purpose of this prospective single-blinded randomized clinical trial will be to evaluate the     effectiveness of the cranial cup in preventing positional head shape deformity in the NICU     patient population.   "
157809|NCT01218074|"     Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs.     This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. The     investigators test the hypothesis that routine use of aggregometry could show antiaggregated     patient and lead to normalization of platelet function via administration of Desmopressin     thus limiting bleeding and transfusions.   "
157810|NCT01218061|"     The main objective of the study is to follow prospectively a cohort of patients with     pre-diabetes to understand the pathophysiological mechanisms involved in switching from     pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in     this population.   "
157851|NCT01216540|"     The primary goal of this study is to determine if there is an association between greater     exposure to vancomycin and the development of nephrotoxicity. The secondary goal is to     estimate the costs to the hospital associated with these nephrotoxic events.   "
157811|NCT01218048|"     There are currently no useful tests to identify patients who will respond to cetuximab     therapy, notably because EGFR levels do not correlate with the clinical responses observed.     Thus, the investigators are investigating the role of cellular immunity and immune escape     mechanisms to explain the differential clinical response to cetuximab.   "
157812|NCT01218035|"     This is a randomized, double-blind and placebo-controlled study to evaluate the efficacy of     zoledronic acid on the biologic incorporation of cementless hip prosthesis in postmenopausal     female patients.The study population consists of postmenopausal female patients scheduled for     total hip replacement because of degenerative hip osteoarthritis. The patients will receive     either a single dose of 5 mg zoledronic acid or placebo intravenously after surgery before     hospital discharge. The patients will be followed-up for 1 year. Zoledronic acid therapy has     been shown to promote bone ingrowth into porous implants in pre-clinical models. The     investigators hypothesis is that zoledronic acid, given as a single intravenous infusion     after hip replacement surgery, enhances bone ingrowth into porous surface of cementless hip     prostheses. As a primary outcome, the therapy is expected to reduce periprosthetic bone loss     measured by DXA. Enhancement of bone ingrowth is expected to increase primary stability of     the hip prosthesis and this effect can be detected with high-precision three-dimensional RSA     imaging modality and in a faster functional recovery of the patients.   "
157813|NCT01218022|"     Objective:      The purpose of this study is to compare the single dose bioavailability of Torrent's Losartan     Potassium Tablets 1 × 100 mg and Cozaar® Tablets 1 × 100 mg of Merck & Co., Inc.      Study Design:      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects.   "
157814|NCT01218009|"     This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After     a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol     or a dummy drug at regular times four times a day. Then for the last nine months of the     study, all subjects will be given the albuterol dry powder inhaler and will use it only when     needed to help with breathing problems. Subjects will need to keep a daily diary (both paper     and electronic) throughout the study recording any inhaler use and health problems. There     will be visits to the study doctor about once a month for a year. This study is intended to     show that the albuterol dry powder inhaler works well and is safe for use over a long period     of time.   "
158058|NCT01214811|"     The purpose of this study is to evaluate the change in signs of inflammation/local infection     when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers     (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of     topical antimicrobial treatment according to the physician.   "
157815|NCT01217996|"     Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) show elevated     rates of working memory impairment. Working memory (WM) is the ability to hold and manipulate     information online; for example, when an individual mentally rehearses a phone number in     order to dial it without writing it down. A computer-based working memory intervention has     been successful in children diagnosed with ADHD and stroke survivors. Individuals     participating in the intervention showed improvements on working memory measures as well as     more complex problem solving skills. Neuroimaging (brain scans) conducted before and after     training showed changes in brain activation suggestive of underlying changes in brain systems     that support working memory. This study investigates the effectiveness of this computer-based     working memory intervention for childhood cancer survivors.   "
157816|NCT01217983|"     Evaluation of kidney function is critical in cirrhotic patients as there is a clear     relationship between renal failure and prognosis. The investigators hypothesized that in this     population new biomarkers of renal function could help in early detection of acute renal     failure and in discrimination between renal and pre-renal causes. Finally the investigators     hypothesized that such biomarkers could predict short-term outcome in this population.   "
157817|NCT01217970|"     This study is designed to collect data to determine whether a medication, ibudilast, is safe     for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan     and South Korea, ibudilast has been used safely in humans as a treatment for asthma,     pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in     outpatient settings with people who have methamphetamine dependence. This would be the first     study to collect this information. This study is important because individuals with     methamphetamine dependence often relapse to meth use, even when in treatment; some number of     individuals who participate in an outpatient study will relapse to methamphetamine while     taking ibudilast. It is crucial to know whether there may be interactions between ibudilast     and methamphetamine before planning an outpatient clinical trial.Ibudilast is an exciting     medication candidate for treating methamphetamine dependence. When individuals become     abstinent from methamphetamine during early recovery, the body starts an inflammatory process     in neurons, especially glial cells. Glial cells are important in that they provide support to     the nerve cells that are involved in thought, movement, and other human activities. By     dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells     during early abstinence, which in turn may help individuals feel better and think better     during treatment.      The study specific aims are to determine whether ibudilast alters:        1. blood pressure and heart rate responses to methamphetamine;        2. the ratings of craving or other drug experiences from methamphetamine;        3. the reward/reinforcing effects of methamphetamine; and        4. the metabolism of methamphetamine.      Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not     looking for treatment will complete this study.   "
157818|NCT01217957|"     The purpose of Phase 1 of this study was to determine the safety, tolerability, maximum     tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral ixazomib administered in     combination with lenalidomide and low-dose dexamethasone in participants with newly diagnosed     multiple myeloma (NDMM). The purpose of Phase 2 of this study was to determine the overall     response rate (ORR) and further evaluate the tolerability and toxicity of the combination of     oral ixazomib, lenalidomide, and low-dose dexamethasone in patients with NDMM.   "
157819|NCT01217944|"     This study is designed to evaluate the efficacy and safety of two different dosing regimens     of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in     patients with visual impairment due to choroidal neovascularization (CNV) secondary to     pathologic myopia (PM).   "
157820|NCT01217931|"     The goal of this clinical research study is to compare 6 different 2-drug sequences of     everolimus, bevacizumab, or pazopanib to learn how they may affect metastatic kidney cancer.     For the 2-drug sequence, participants will receive 1 of these drugs and may start taking     another of these drugs after that. Researchers will also study the safety of these 2-drug     sequences.   "
157821|NCT01217918|"     Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when     administered to healthy Japanese subjects once a day (QD) for 10 days.   "
157822|NCT01217905|"     This is a study in Japanese healthy volunteers to determine the safety and tolerability of     the compound AZD7687. It will also assess how the body handles the drug and how it responds     to the drug following single dose followed by multiple dosing over 7 days.   "
157852|NCT01216527|"     The primary objective is to compare neo-adjuvant chemoradiotherapy followed by surgery versus     surgery, in terms of the overall survival time (OS) in patients with Stage IIB or III     squamous cell esophageal carcinoma.   "
157823|NCT01217892|"     This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5     mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is     beneficial in diabetes treatment, and if so, how it compares to treatment with metformin     alone.   "
157824|NCT01217879|"     In the light of ONTARGET and TRANSCEND studies results, it would be interesting to     investigate the real-life telmisartan treatment tolerability. It is well known and accepted     that the Real-life setting is much more adequate to reflect the antihypertensive and safety     properties of the drug in comparison to the organized and scheduled setting of the clinical     trial. Because there are not much data on the cough in relation to telmisartan, therefore it     would we worth to observe the cough frequency and general treatment tolerance in patients     treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.   "
157825|NCT01217866|"     Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic     portion of the case used an EN~SEAL device to Group B - the laparoscopic BSO was done using a     3mm EN-SEAL device through 2 lateral 5mm ports.   "
157826|NCT01217853|"     A study in which intraocular pressure (IOP) will be monitored over 24 hours using the     SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle     glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP     patterns emerging from SENSIMED Triggerfish and GAT.   "
157865|NCT01217580|"     The purpose of this study is to determine if injecting a local anesthetic, or numbing     medication, above each hip will decrease the amount of narcotic pain medicine that is     typically required by a patient after a cesarean delivery. Ultrasound pictures will be used     to guide placement of this injection. Either ropivicaine (a type of numbing medication called     a local anesthetic) or a placebo (saline) will be injected. For 24 hours, you will be given a     button to press when you have pain. When the button is pressed, you will be given a small     amount of pain medication called hydromorphone through your IV. You will also be given a pain     medication called ketorolac through your IV every 8 hours for 24 hours after surgery.   "
158059|NCT01213823|"     The purpose of this study is to estimate the relative risk of severe hepatic injury in     hospitalized patients with invasive candidiasis and candidemia who received anidulafungin,     compared to patients who received caspofungin and/or micafungin.   "
157827|NCT01217840|"     Large studies of children show that over half of the children in the United States of America     do not have enough vitamin D stored in their bodies. In children who are overweight or obese,     the percentage of children who do not have enough vitamin D is even higher.      Vitamin D is essential for the body to maintain normal calcium levels and strong bones.     Recent research shows that through the actions of inflammatory markers, levels in the blood     that measure inflammation in the body, vitamin D plays many other important roles in the body     like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat.      The purpose of this study is to determine the effect of vitamin D supplementation on     inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like     to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin     D stores and inflammatory cytokines.      In an observed, randomized controlled trial over 6 months we will provide observed vitamin D     supplementation or placebo to healthy obese and overweight adolescents and measure changes in     inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that     administration of vitamin D to these patients will improve their inflammatory profile and     cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).   "
157828|NCT01217827|"     Despite being a proven life-saving intervention in appropriately selected individuals,     multiple studies continue to demonstrate low implantation of defibrillators in potential     candidates. Based upon prior research, a major barrier to low utilization is low referral of     potential candidates by healthcare providers. In this study, via brief clinical reminder     placed in the electronic medical record, we ask healthcare providers who have not referred     potential candidates for defibrillator the reasons for this decision and provide them with     the tools for referral if appropriate.   "
157829|NCT01217814|"     Primary Objective:      - Demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate [MTX] is superior in     efficacy to placebo for the relief of signs and symptoms of Rheumatoid Arthritis [RA], in     patients with active RA who have failed up to 2 Tumor Necrosis Factor α [TNF-α] antagonists.      Secondary Objectives:        -  Assess the safety of sarilumab;        -  Document the pharmacokinetic profile of sarilumab.   "
157830|NCT01217801|"     The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg     with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study     participants under fed conditions.      The purpose is to monitor clinical status, adverse events, laboratory investigations and to     assess relative safety and tolerance of ondansetron formulations under fed conditions.   "
157831|NCT01217788|"     The purpose of this study is to determine the efficacy of PH94B, a new class of therapeutic     compound, administered intranasally for the management of acute anxiety in patients diagnosed     with generalized social phobia.   "
157832|NCT01217775|"     The objective of this study is to evaluate the effectiveness and safety in double-blind,     randomized, placebo-controlled clinical trials of self administered PH80 intranasal spray for     the acute management of cycle related symptoms in women who regularly experience premenstrual     dysphoric disorder (PMDD).   "
157833|NCT01217762|"     The purpose of this study is to evaluate the safety and clinical feasibility of the IRay     System for the treatment of wet age-related macular degeneration (AMD).   "
157834|NCT01217749|"     The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily     regimen of orally administered PCI-32765 combined with ofatumumab in subjects with     relapsed/refractory CLL/SLL and related diseases   "
157835|NCT01217736|"     The objective of the study is to determine the magnitude of the effect of direct renin     inhibition by VTP-27999 on renal plasma flow and kidney function.   "
157836|NCT01217723|"     This is a randomized trial for patients undergoing hematopoietic progenitor cell     transplantation (HPCT) from an unrelated donor. Approximately 50% of the patients enrolled     will receive Thymoglobulin® as part of the preparative regimen prior to HPCT. The other 50%     of the patients enrolled will receive a standard preparative regimen. Thymoglobulin is known     to suppress the types of cells that can cause a transplant complication known as chronic     graft versus host disease (cGVHD). The goal of this trial is to find out if adding     Thymoglobulin to the preparative regimen will result in a decrease in cGVHD.   "
157837|NCT01217710|"     The objective of this project is to validate the proposed smartphone-based activity monitor     and to test its use for Motivational Interviewing based counseling for physical activity in     Chronic Obstructive Pulmonary Disease (COPD).   "
157838|NCT01217697|"     The purpose of this study is to collect additional safety information on abiraterone acetate     administered with prednisone to patients with metastatic castration-resistant prostate cancer     (CRPC).   "
158038|NCT01215084|"     The primary objective of the study is to determine the Pharmacokinetic (PK) and safety     profiles of fampridine-PR 10 mg in Chinese and Japanese adult healthy volunteers. The     secondary objective of this study is to compare the PK and safety profiles of fampridine-PR     10 mg among the Chinese, Japanese, and Caucasian adult healthy volunteers.   "
157839|NCT01216696|"     This is an Open-label, single-arm, phase II study of ipilimumab in patients with spontaneous     preexisting immune response to NY-ESO-1.      Preclinical data suggest, that CTLA-4 blockade enhances polyfunctional T cell responses in     patients with melanoma. Thus patients with immunological response to NY-ESO-1 might benefit     from an anti CTLA-4 treatment.      Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction     period, followed by a radiological assessment in week 12. Patients with clinical benefit     (partial response, complete response or stable disease according to the immune-related     response criteria) will continue with an ipilimumab administration every 3 months starting at     week 24 up to week 48 until the end of the study or until disease progression,toxicities     requiring discontinuation   "
157946|NCT01216280|"     This study is to evaluate the efficacy and tolerability of multiple oral doses of     Natura-alpha capsule administered to patients with active ulcerative colitis. This will be a     randomized, double-blind, placebo-controlled, parallel-design study. Up to 75 patients will     complete this study (20 to 25 patients per treatment group) at approximately 10-12 clinical     sites in the Unites States. Patients will be assigned at a 1:1:1 ratio to receive placebo,     Natura-alpha 10 mg or Natura-alpha 20 mg, b.i.d. Replacement patients may be added, pending     Sponsor approval, if it appears that less than 60 patients will complete the study.   "
157840|NCT01216683|"     RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies,     such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells     from growing. It is not yet known whether giving bendamustine hydrochloride and rituximab     together alone is more effective than giving bendamustine hydrochloride and rituximab     together with bortezomib or lenalidomide in treating follicular lymphoma.      PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and     rituximab together with or without bortezomib followed by rituximab with or without     lenalidomide to see how well they work in treating patients with high-risk stage II, stage     III, or stage IV follicular lymphoma.   "
157841|NCT01216670|"     The CARRYING ON for heart failure (HF) study is a national, prospective, post market     interventional, multi-center, open-label, pilot trial.The purpose of the study is to assess a     short term and a long term period, incidence of pre-specified clinical and arrhythmic events     in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac     decompensation.   "
157842|NCT01216657|"     Sunitinib is a novel small molecule receptor tyrosine kinase inhibitor with direct antitumor     effects as well as antiangiogenetic activity. Preclinical and clinical data for Sunitinib and     data about angiogenesis and growth regulation in melanoma suggest the activity of Sunitinib     in melanoma. This study will investigate the efficacy, safety and tolerability of Sunitinib     as palliative treatment in chemo-refractory metastatic melanoma.   "
157843|NCT01216644|"     Patients with locally advanced resectable adenocarcinoma of the stomach or the     esophagogastreal junction without previous therapy will be treated with one of two     chemotherapy combinations before and after surgery. One half of the patients gets     5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Epirubicin,     Cisplatin and 5-FU (ECF). Main objective of the study is median overall survival.   "
157844|NCT01216631|"     The aim of this study is to establish the efficacy and duration of effect of intra-articular     (IA) infliximab vs intravenous infliximab vs current standard care (IA steroid injections) in     seronegative oligoarthritis. All patients will have seronegative arthritis affecting less     than 5 joints but including at least one knee. 10 patients will receive IA infliximab     injections to the affected knee, 10 will receive IA steroid injections to the affected knee     and 10 will receive a course of intravenous infliximab. Patients will not be aware of their     group as this is a placebo-controlled study.   "
157845|NCT01216618|"     The study is a prospective, multi-center, open label, randomized; two-arms cross over study.      This is the test protocol for the InsuPatch device, whose purpose is to improve insulin     delivery into the blood when the insulin is infused using an insulin-infusion pump by     controlled heating of the area surrounding the point of infusion.   "
157846|NCT01216605|"     The present study was designed to investigate the effects of a single dose of synthetic     oxytocin on facial emotion recognition in healthy adult man. Pictures of emotional faces are     presented very briefly for a few milliseconds in a backward-masking paradigm in order to vary     the level of awareness. In a randomized placebo-controlled between-subject design,     recognition performance is compared between a drug (24 IU oxytocin) and a placebo condition.     We hypothesize that oxytocin enhances emotion recognition even for facial stimuli processed     with limited awareness.   "
157847|NCT01216592|"     Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease with high     prevalence worldwide and with relevant impact on patient-related quality of life, morbidity     and mortality. There is evidence that airway inflammation correlates with the severity of the     disease and that airway inflammation is further enhanced during exacerbation. However, it is     unknown whether daily fluctuation of symptoms or changes in lung function is paralleled by     changes in airway inflammation.   "
157848|NCT01216579|"     The investigators hypothesise that titration of asthma medication against mannitol challenge     results will reduce the number of mild asthma exacerbations, in one year, when compared with     titration against BTS guidelines. To test this hypothesis the investigators propose a primary     care, parallel treatment, patient blinded study in which matched groups of asthmatic patients     will be treated in accordance either with BTS guidelines or with our treatment algorithm     dependent on mannitol challenge result.      Purpose of the study is to evaluate the efficacy of a treatment algorithm based on the     measurement of airway hyperresponsiveness to mannitol challenge, a surrogate marker of airway     inflammation, in the long term treatment of asthma in comparison to BTS guidelines.   "
157849|NCT01216566|"     The purpose of this study is to investigate the efficacy and safety of the Occiflex device in     the treatment of neck pain.   "
157850|NCT01216553|"     The aim of the study was to investigate the utility and safety of home management of home     oxygen therapy in acute bronchiolitis. A matched case-control study, of one hundred and     thirty five infants aged less than 12 months diagnosed bronchiolitis with hypoxia attending a     pediatric community clinic will be randomly assigned to receive oxygen with or without     standard nebulized therapy. Nebulized treatment with either 0.1% epinephrine diluted in     bromhexine, or 3% hypertonic saline. Intermittent oxygen treatment will be administered 6     times daily for 7 days. Primary outcome measures will be emergency department     visits/hospitalization secondary outcome measures will be changes in Bronchiolitis Caregiver     Diary Score.   "
157866|NCT01217567|"     The Purpose of this study is to compare two methods for closure of the skin after caesarean     section on the same patient; staples and subcuticular sutures. The study is performed on two     separate groups of patients: 1. Woman having cesarean section for the first time and have not     previously had abdominal surgery through a lower abdominal transverse incision. 2. Woman, who     have previously had a caesarean section done. The following parameters are registered:        1. An objective evaluation of the two ends of the scar 6 months postoperatively.        2. A patient evaluation of the two ends of the scar 6 months postoperatively.        3. The difference in pain in the two ends of the scar 1 day postoperatively (blinded).        4. The difference in pain in the two ends of the scar 7 days, 3 and 6 months          postoperatively.        5. The rate of infection.   "
157853|NCT01216514|"     Factors forecast Chronic Inflammatory Bowel Diseases (IBD) remain at present essentially on     clinical factors (extension of the disease, achievement of the perianal ring, requirement of     surgery, treatment by immunomodulators…). All IBD specific immunological or serological     markers showed only a diagnostic role for indefinite colitis (hemorrhagic Rectocolitis vs     Crohn Disease) but were never able to be considered as predictive elements of adults IBD     evolution. Among the most used, the presence of ANCA's antibody and ASCA allows to separate     hemorrhagic rectocolitis (ANCA + / ASCA-) from Crohn disease (ANCA-/ASCA +) and their     combination present an average sensibility about 85 % and a 85 % specificity. However, 8     other antibody types were recently isolated and estimated individually during IBD in     particular during child Crohn diseases (anti-OmpC, anti-I2, anti-CBir1, anti-glycans (ALCA,     AMCA and ACCA) anti-Goblet cells and albicans Candida's specific anti-mannan). These     complementary assays improve significantly the reliability of the diagnosis. However, if the     use of these new markers has an indisputable diagnostic role, their predictive role in the     evolution of IBD was estimated at the adult's only rarely during Crohn diseases.     Consequently, the investigators suggest realizing an exhaustive analysis of all these new     immunological markers to define, if their association can have an interest in the     differentiation of stable (or little evolutionary) and unstable (or quickly evolutionary)     clinical forms.   "
157854|NCT01216501|"     In children, radiofrequency catheter ablation (RFCA) or cryoablation are highly effective     treatments for supraventricular tachycardia treatment. General anesthesia is often required     to ensure comfort during the prolonged procedure and to assure immobility in order to     facilitate accurate mapping and subsequent ablation of the accessory pathway and/or     arrhythmogenic focus. Successful anesthetic management of this patient population requires     adequate suppression of sympathetic responses during the procedure while electrophysiological     parameters remain unaltered for mapping purposes and subsequent ablation. Although     Sevoflurane (SEVO) and Isoflurane (ISO) are two commonly used and evaluated volatile     anesthetic agents for ablation procedures, comparison of those agents has not been performed     previously not in adults, not in children.      Hypothesis Time required for basic EP intervals, successful induction of SVT and successful     RFCA or cryoablation in children will not be different between patients undergoing     Sevoflurane or Isoflurane-based anesthesia.   "
157855|NCT01216488|"     Hospitalized patients for superior member surgery have different types of anesthesia.Forearm     and/or arm surgery could be done under general anesthesia, but in the most of the cases, this     surgery was done under locoregional anesthesia.Several injections of local anesthesia at the     nerves axilla are used with the used of ultrasonography.      The purpose of this study is to show that the anesthesia efficiency is the same with 40 or 25     ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.   "
157856|NCT01216475|"     Background: Small Incision Lenticule Extraction or SMILE is a novel form of 'flapless'     corneal refractive surgery that was adapted from Refractive Lenticule Extraction (ReLEx).     SMILE uses only one femtosecond laser to complete the refractive surgery, potentially     reducing surgical time, side effects and cost. If successful, SMILE could potentially replace     the current, widely practiced Laser In-situ Keratomileusis or LASIK. The aim of this study is     to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at     3-months post-operatively.      Methods/ Design: Single tertiary center, parallel group, single-blinded, paired-eye design,     non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be     enrolled for study after informed consent. Each participant will be randomized to receive     SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority     trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00D)     at a tertiary eye center in terms of refractive predictability at 3 months post-operatively.     Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE     differs from LASIK in adults (>21 years old) with myopia (> -3.00D) at a tertiary eye center     in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3     months post-operatively. Our primary outcome is refractive predictability, which is one of     several standard refractive outcomes, defined as the proportion of eyes achieving a     postoperative spherical equivalent (SE) within ±0.50 diopter (D) of the intended target.     Randomization will be performed using random allocation sequence generated by a computer with     no blocks or restrictions, and implemented by concealing the number-coded surgery within     sealed envelopes until just before the procedure. In this single-blinded trial, subjects and     their caregivers will be blinded to the assigned treatment in each eye.      Discussion: This novel trial will provide information on whether SMILE has comparable, if not     superior, refractive outcomes compared to the established LASIK for myopia, thus providing     evidence for translation into clinical practice.   "
157857|NCT01217684|"     The purpose of the present study is to evaluate test-retest reliability of a standard     protocol on the Biodex dynamometer in older adults.      In addition, the test-retest reliability and validity of an experimental measure of knee     extension strength will be assessed in older adults.   "
157858|NCT01217671|"     This is a randomised , placebo controlled, double blind , multicentre, Phase II/III study     evaluating the safety and efficacy of Kamada AAT for inhalation in patients with Emphysema     caused by Alpha-1 Antitrypsin (AAT) deficiency.   "
157859|NCT01217658|"     Excessive infant crying (EIC) is likely to increase the risk of child abuse. The     investigators propose a randomized trial using an intervention based on recommendations of     Karp. The investigators will systematically identify 170 term infants with EIC and conduct     assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces     mean infant hours of night-time crying, increases maternal soothing behaviors and improves     parental anxiety and depression.   "
157860|NCT01217645|"     This is a study to assess the distribution, metabolism and excretion of [14C]AZD6765 after a     single-dose intravenous administration.   "
157861|NCT01217632|"     The overall goal of this trial is to evaluate the efficacy of FG-3019 for reversing liver     fibrosis in subjects with chronic hepatitis B infection who are beginning antiviral therapy     with entecavir. This Phase 2 randomized, double-blind, placebo controlled study will enroll     subjects with chronic active hepatitis B infection and liver fibrosis (Ishak score ≥2) who     are eligible for antiviral therapy.   "
157862|NCT01217619|"     This is a single arm, one center, phaseⅡ study evaluating efficacy and safety of erlotinib as     neoadjuvent treatment in patients with EBUS confirmed stage ⅢA N2 NSCLC with activating EGFR     mutation in exon 19 or 21.   "
157863|NCT01217606|"     This study will evaluate the safety and efficacy of Triple Combination Therapy compared with     Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary     open-angle glaucoma or ocular hypertension.   "
157892|NCT01217229|"     PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity.The primary     objective of this study is to evaluate the efficacy, as measured by overall response rate, of     orally administered PLX3397 in patients with relapsed or refractory classical Hodgkin     lymphoma (HL). Secondary objectives include safety, the duration of response, the disease     control rate, progression free survival, and how the drug affects your body.   "
157867|NCT01217554|"     Low back pain (LBP) is considered one of the most common musculoskeletal disorders in modern     society, resulting in substantial costs to society. Factors associated with the development     of low back pain include poor posture, strenuous work with the body, inadequate non ergonomic     work and traumas.      Rotation movement pattern of the lumbar spine in different positions is essential aspect in     understanding the LBP Pathophysiology. Rotation coupled with forward bending (flexion) is a     dominant factor which could increase the risk LBP and disc prolapse. There is also a decline     in range of motion (ROM) of rotation in forward bending (flexion) compared to neutral     position during sitting and standing.      In addition,lumbar rotation movement patterns differ in population with LBP compared to     asymptomatic individuals. Healthy individuals exhibit rotation accompanied by consistent     coupled movement patterns of lateral bending in the opposite direction at thr upper levels,     and by lateral bending in tge same direction at the lower levels . while Chronic LBP patients     exhibit non consistent patterns altered from those of the normal population.   "
157868|NCT01217541|"     Dementia is a serious health problem showing an increasing prevalence rate with increasing     age. In Norway, about 80% of nursing home patients have dementia. The mean age of nursing     home residents in Norway is around 84 years. Disruptive and agitated behaviour affect 30-50%     of all individuals with dementia at some point in the course of the illness. In addition,     they have a combination of physical and psychological diseases which necessitates a close     collaboration between different specialities in medicine and Old Age psychiatry. In     collaboration with the communalities, our Old Age psychiatry services want to provide a new     approach to this challenge and validate it on patient and personnel level.   "
157869|NCT01217528|"     The purpose of this study is to determine efficacy of a dedicated programming concept for     avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient     with primary prevention ICD indication.   "
157870|NCT01217515|"     A Phase III, multicentre, randomised, double blind, placebo-controlled study in subjects     having anal fissure (AF) with AF-related pain. Subjects will undertake a 1-week screening     period to provide baseline data and for assessment of eligibility. At the Baseline visit     (Week 0), eligible subjects (having an average Numerical Rating Scale (NRS) score of >4 for     worst pain associated with or following defaecation) will be randomised on a 1:1:1 basis to     one of the three treatment groups. Subjects will receive diltiazem hydrochloride 2% cream or     diltiazem hydrochloride 4% cream or placebo cream. Study treatment will be applied in and     around the anus, three times daily, for up to 8 weeks. Following the Week 0 Visit, subjects     will be contacted by telephone during Week 1 to ensure adequate compliance with study     treatment, to ensure that study drug is being tolerated and that any concomitant medications     are used at a level consistent with that prior to randomisation. Subjects will return to the     clinic for safety and efficacy assessments at Weeks 2, 4, and 8 and receive a follow-up     telephone call at Week 12, following cessation of therapy.      Concomitant laxatives and stool softeners will be permitted, as needed, during the entire     study period (screening and treatment) to ensure that constipation or passage of hard stools     does not confound evaluation or improvement of the condition. Fibre supplements will be     allowed but should be continued at the baseline level.      Instructions on the use of the Interactive Voice Response System (IVRS) diary will be issued     to subjects to record fissure-related pain (NRS) and bowel symptoms daily during the 1-week     screening period, to confirm eligibility and post-randomisation to record worst anal pain     associated with or following defaecation (NRS) and daily overall AF-related pain (NRS). A     record of the number of times the subject has defaecated, laxative and analgesic usage will     also be made as well as the number of applications of study treatment, any changes to     concurrent medications and any Adverse Events (AEs).      In addition, at some or all study visits, subjects will record the Patient's Global     Impression of Improvement (PGI-I) on a 7 point Likert scale, complete a Short Form 36 (SF-36)     quality of life questionnaire and will undergo examination of their AF. Routine blood samples     will be taken and the Skin Irritation Score (SIS) recorded for safety evaluations.      Subjects may receive permitted medications for pain per Entry Criteria, but these should     remain stable, where possible, up to the Week 8 Visit. Introduction of any new medication for     AF will not be permitted unless the Investigator deems rescue intervention necessary. A     subject will be deemed a treatment failure if rescue intervention is required and will have     to be withdrawn from the study.      Any subject leaving the study following randomisation for any reason will be asked to     complete the Early Withdrawal Visit. This includes subjects who withdraw due to the     development of AEs or intolerance, as well as subjects who require rescue intervention. These     subjects will return for safety follow-up visits at their previously scheduled follow-up     assessment appointments. If complete healing has occurred at the 2 or 4 Week visits, (i.e.     prior to the end of the 8-week treatment period), subjects will be asked to continue applying     the medication for the full 8 week course, up to the final assessment.      Following the Week 8 visit (or Early Withdrawal Visit), subjects will be followed up for a     further 4 weeks (following cessation of study medication) to note any AEs.      All routine blood analyses (haematology and biochemistry) and plasma levels of diltiazem and     of its principal metabolites will be analysed by central laboratories.   "
157871|NCT01217502|"     This study aims to determine the effectiveness of a self-management program for elderly with     an acquired and concurrent hearing and visual impairment due to age-related disease     processes.   "
157872|NCT01217489|"     The Signascan Electrical Impedance Mammography (EIM) Study is a pilot study of a non-invasive     medical device - a novel approach to breast cancer detection using Electrical Impedance     Mammography (passing minute electrical currents through the tissues and detecting the changes     to the currents as a result of the tissues, which can differentiate between normal and     malignant tissue). The trial is a prospective trial of diagnostic capability of the device,     as compared with standard care (diagnosis provided by the concurrent NHS investigation -     imaging, surgery etc) performed for female patients attending the symptomatic breast clinic     for investigation. The aim is to assess the diagnostic efficacy in detecting 100 true     malignancies, and continue to recruit until 300 patients with true malignancies have been     recruited if necessary.   "
157873|NCT01217476|"     Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development     code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken     Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit     consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent     for solution and a spray part to fit the glass bottle after reconstitution of the final     product.      We conduct a multinational, randomized, double-blind, placebo controlled, parallel-group,     multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and     a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior     wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after a maximum of 12     weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition     to best local care (off-loading, dressings). Approximately 210 patients will be randomized     and it is planned that this study will be conducted at approximately 40 investigational sites     in Europe.   "
157893|NCT01217216|"     To test the effectiveness and feasibility of intensive motivational, behavior modifying     intervention aimed at improving physical activity and dietary habits to produce at least 7%     weight loss in women with a history of breast cancer in a community health setting.   "
158039|NCT01215071|"     Study is meant to evaluate the influence of different extension of pelvic lymphadenectomy on     outcome of patients with bladder cancer.   "
157874|NCT01217463|"     Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development     code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken     Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit     consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent     for solution and a spray part to fit the glass bottle after reconstitution of the final     product.      The investigators conduct a multinational, randomized, double-blind, placebo controlled,     parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment     phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to     demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic     origin after 12 weeks topical daily application of trafermin 0.01% spray compared with     placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients     will be randomized and it is planned that this study will be conducted at approximately 30     investigational sites in an estimated 4 countries in Europe (Czech     Republic,France,Hungary,Italy,).   "
157875|NCT01217450|"     This phase I trial is studying the side effects and the best dose of MEK Inhibitor AZD6244     when given together with cetuximab in patients with advanced or refractory solid tumors that     cannot be removed by surgery. MEK inhibitor AZD6244 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances     to them. Giving MEK Inhibitor AZD6244 together with cetuximab may kill more tumor cells.   "
157909|NCT01217008|"     The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single     time-point between 7 and 14 days post injury, inclusive, to patients with neurologically     complete spinal cord injuries (SCI).   "
157910|NCT01216995|"     Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs     delivered via the intracoronary route in the treatment of patients with ST-elevation acute     myocardial infarction (STEMI).   "
157876|NCT01217437|"     This randomized phase II trial studies how well giving temozolomide and irinotecan     hydrochloride together with or without bevacizumab works in treating young patients with     recurrent or refractory medulloblastoma or central nervous system (CNS) primitive     neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. It is not yet known whether temozolomide and     irinotecan hydrochloride are more effective with or without bevacizumab in treating     medulloblastoma or CNS primitive neuroectodermal tumors.   "
157877|NCT01217424|"     RATIONALE: Reflexology and aromatherapy massage may lessen symptoms in patients with cancer.     It is not yet known whether reflexology is more effective than aromatherapy massage in     relieving symptoms in patients with cancer.      PURPOSE: This randomized clinical trial is studying reflexology to see how well it works     compared with aromatherapy massage in relieving symptoms in patients with cancer.   "
157878|NCT01217411|"     This randomized phase I/II trial studies the side effects and the best dose of RO4929097     (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with     whole-brain radiation therapy or stereotactic radiosurgery and to see how well it works     compared to whole-brain radiation therapy or stereotactic radiosurgery alone in treating     patients with breast cancer or other cancers (such as lung cancer or melanoma) that have     spread to the brain. RO4929097 may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Whole-brain radiation therapy uses high energy x-rays deliver     radiation to the entire brain to treat tumors that can and cannot be seen. Stereotactic     radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to     normal tissue. It is not yet known whether giving RO4929097 together with whole-brain     radiation therapy or stereotactic radiosurgery may kill more tumor cells.   "
157879|NCT01217398|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Giving temozolomide together with bevacizumab     may kill more tumor cells.      PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to see     how well they work in treating patients with metastatic melanoma of the eye.   "
157880|NCT01217385|"     RATIONALE: New imaging procedures, such as diffuse optical spectroscopy imaging, may help     measure a patient's response and allow doctors to plan better treatment.      PURPOSE: This clinical trial studies diffuse optical spectroscopy imaging in monitoring and     predicting response in patients with locally advanced breast cancer undergoing chemotherapy     before surgery.   "
157881|NCT01217372|"     Calcium oxalate nephrolithiasis is a relatively common disease. The prevalence in the general     population may range from 10 to 12 percent, and 0.4 to 1 percent of new cases are reported     every year according to different series. Without specific pharmacological therapy, the     recurrence rate in patient with established diagnosis of nephrolithiasis is extremely high     and may range from 15 to 20 percent per year, with a cumulative incidence at five years     ranging from 27 to 50 percent.Although genetic factors play an important role in the     development of nephrolithiasis, environmental factors such as diet also appear to affect     stone formation. Potassium citrate is also effective in preventing stone recurrence in     patients with calcium oxalate nephrolithiasis. Low tolerability, however, may remarkably     limit the use of these medication. Citrus fruits are a natural rich source of citrate and     diet supplementation with juice of citrus fruits may represent a valuable alternative option     to supply citrate without exposing the patients to the adverse effects of citrate containing     medications. Among the most commonly consumed citrus fruits, lemons contain the greatest     concentrations of citric acid (49,2 g/Kg);a half cup of pure lemon juice can provide a daily     amount of citrate comparable to that of a standard daily dose of alkali citrate medications.      A few studies tried to evaluate the effects of lemon juice supplementation in patients with     calcium oxalate nephrolithiasis, but the findings were flawed by the retrospective,     observational design of the study or by the too small sample size that limited the power of     statistical analyses and the reliability of the results. This study will be primarily aimed     at evaluating whether lemon juice added to standard diet recommendations compared to diet     recommendations alone may reduce the risk of new stone formation in patients with recurrent     idiopathic calcium oxalate nephrolithiasis. Secondarily, the study will evaluate the effects     of lemon juice supplementation on complications of nephrolithiasis such as urinary tract     infections, colic symptoms, and hospitalizations for stone disruption or removal, as well as     the effects on urinary factors (such as urinary citrate, oxalate, calcium excretion or pH)     that may favor or limit stone formations and the relationships between these effects and the     risk of stone recurrence.   "
157894|NCT01217203|"     The primary objective of the clinical study is to evaluate, in patients who experience a     first or second relapse of their multiple myeloma, the safety of escalating doses of IPH2101     combined with lenalidomide   "
158040|NCT01215058|"     The purpose of this study is to assess gastroprotective agent compliance in patients at risk     suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer with NSAID.   "
157882|NCT01217359|"     Purpose:      The purpose of this exploratory study is to evaluate phosphoprotein profiling to determine     differences in the intracellular actions of interferon or interferon stimulated genes among     people with different treatment outcomes to interferon based therapy for hepatitis C (HCV).     Participants: Patients with genotype 1 HCV who have had interferon based therapy at the     University of North Carolina (UNC). Procedures: Thirty patients with varied responses to     treatment will be given a single subcutaneous injection of interferon alpha 2b. Prior to the     injection and at 30 minutes, 1,2,4,6,12 and 20 hours after injection, blood will be drawn for     analysis of phosphoprotein profiling and changes in serum cytokines.   "
157883|NCT01217346|"     Cardiac syndrome X consists of a triad of chest pain, abnormal exercise stress testing and     normal coronary angiogram, and is hypothesized to be related to endothelial dysfunction.     Endothelial dysfunction is also reported to be linked to obstructive sleep apnea. While chest     pain can be one of potential presenting symptoms of obstructive sleep apnea, the     investigators hypothesize that obstructive sleep apnea is common in subjects with cardiac     syndrome X.   "
157911|NCT01216982|"     Stress-related disorders are among the most prevalent and expensive medical consequences of     participation in military operations. Omega-3 fatty acids EPA/DHA derived from fish oil are     known to benefit both neuronal development in the young, and cognition and mood in various     populations.      It is possible that soldiers receiving Omega-3 EPA/DHA will exhibit significantly higher     cognitive performance, better affect/mood state, and less combat stress symptomatology     compared to the placebo after 12 weeks of supplementation. A goal would be to reduce the     prevalence of combat stress injuries in military personnel.   "
157884|NCT01217333|"     The investigators community based resource center has implemented visit preparation by     prompting patients to write down their questions. This is a proven approach to increasing the     number of questions and concerns that patients voice during their visits with doctors. The     resource center's usual practice is to provide their visit preparation intervention, called     Consultation Planning, through in-person counseling sessions. This study asks whether     telephone delivery of Consultation Planning would be almost as effective in terms of     increasing patient's decision self-efficacy, or confidence in their ability to navigate     decisions effectively with their physicians. The study also asks about the cost-effectiveness     of telephone delivery compared to in-person delivery. The investigators are answering these     questions through a randomized, controlled, non-inferiority trial with two arms: in-person     versus telephone delivery of Consultation Planning. The investigators are measuring     self-reported psychological outcomes such as decision self-efficacy (primary outcome),     preparation for decision making, anxiety, and distress, along with economic outcomes such as     health resource utilization and willingness to pay. The investigators hypothesize that     Tele-CP can be delivered at a lower patient and resource center cost than in-person CP, and     that it will be as effective in terms of impact on a patient's decisional self-efficacy.   "
157885|NCT01217320|"     Creatine supplementation may improve strength, muscle mass, bone mass and muscle function in     healthy and elderly people. The investigators speculate that creatine supplementation could     have therapeutic effects in pediatric rheumatic (i.e., juvenile systemic lupus erythematosus     and juvenile dermatomyositis) patients who usually present muscle weakness, muscle wasting     and bone mass loss.   "
157886|NCT01217307|"     The investigators will evaluate the effect of metformin therapy during 4 months in     non-diabetic patients following ST-elevation myocardial infarction on left ventricular     ejection fraction as measured with cardiac magnetic resonance imaging, compared to placebo.   "
157887|NCT01217294|"     Pain control after hip replacement surgery is important to ensure patient comfort, allow     mobilisation, and aid recovery. The investigators propose a simple and pragmatic study     comparing two different anaesthetic techniques in the provision of pain relief after hip     surgery. Patients will be randomised to receive either spinal anaesthesia containing morphine     or spinal anaesthesia without morphine and an ultrasound guided fascia iliaca nerve block.     Although morphine is an effective pain killer, its side effects include itch, urinary     retention, nausea and potentially fatal breathing problems. If the nerve block can be shown     to provide comparable pain relief to spinal morphine, then morphine could be removed from the     spinal injection. This could reduce side effects and improve patient safety. The     investigators wish to investigate whether ultrasound guided fascia iliaca plane block     provides analgesia which is comparable to that of intrathecal opioid for primary hip     arthroplasty in the first 24 hours after hip replacement surgery   "
157888|NCT01217281|"     Periodontal disease is a bacterially-induced inflammation. As such, it can become a point of     entry of bacteria, toxins and cytokines into the systemic blood circulation, thus adversely     affecting the function of kidneys. This is turn can aggravate the condition of patients with     CKD.      The study hypothesis is that periodontal therapy can improve renal function in patients with     CKD and lower the blood levels of markers for systemic inflammation.   "
157889|NCT01217268|"     The investigators want to evaluate the use of video-conference in the collaboration between     the investigators psychogeriatric department and nursing homes. The study aim is to give     supervision on a regular basis to the caregivers on a special care unit for patients with     dementia with behavioural disturbances during a period of half a year. The investigators want     to investigate the impact on caregivers and patients by applying certain tests at baseline,     during the intervention and half a year after the intervention.   "
157890|NCT01217255|"     Because of high cost, persons with hemophilia in many developing countries cannot afford     adequate treatment. For example, many persons with hemophilia in India and China are only     rarely treated with factor replacement in response to bleeds, and as a result many have     developed significant arthropathy and disability. A pilot study in China estimated the mean     Hemophilia Joint Health Score (HJHS) at 13.1 (SD 9.03) suggesting that these children had     highly prevalent, severe joint disease. The lack of relationship between the HJHS and     treatment history suggests overall inadequate therapy.      The proposed study will quantify the burden of arthropathy, physical disability, and quality     of life (QoL) in boys with hemophilia in Brazil - where comprehensive treatment is just     beginning to be widely available. This study will also provide an opportunity to compare     these outcomes to those observed in Canada, where the dominant therapy has become life-long     prophylaxis.   "
157891|NCT01217242|"     The investigators would like to understand how the physical activity levels and body size of     a child with cerebral palsy (CP) in a clinical situations versus out in the community relates     to what they want to do in day to day life (participation in life). The investigators believe     that what a child really does out in day to day life will predict life participation to a     greater degree than what they do in a structured clinical situation (i.e. therapy session     with therapist). The investigators think that increased body size with normal growth is     related to less physical activity and participation in day to day life for children with     cerebral palsy (CP) who can walk. This project will use a novel accelerometer to measure     walking activity during day to day life.   "
157895|NCT01217190|"     The purpose of this study was to assess the single dose bioequivalence of Ondansetron OSF 8mg     (Manufactured by MonoSol Rx, USA) with Zofran ODT® (Containing Ondansetron 8 mg)     (Manufactured by Cardinal Heasth Blagrove, Swindon, Wiltshire, UK, SN58RU for Glaxo     SmithKline, Research Triangle Park, NC 27709, Made in England) in healthy, male and female     adult, human study participants under fasting conditions.      • To monitor clinical status, adverse events, laboratory investigations and to assess     relative safety and tolerance of ondansetron formulations under fasting conditions.   "
157896|NCT01217177|"     The cervix cancer is the second malignant neoplasia more common between women. The combined     treatment involving chemotherapy and radiotherapy was defined as the standard. This study     will evaluate the safety, toxicity and maximal tolerated dose (MTD) of everolimus in     association with cisplatin and pelvic radiotherapy, in patients with squamous cells carcinoma     of uterine cervix, in stages IIB and IIIB.   "
157945|NCT01216293|"     The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR),     once daily (QD), on bone homeostasis.   "
157897|NCT01217164|"     Adequate nutrition is important for preventing malnutrition in the postnatal period and thus     optimize growth and development of children born prematurely. To avoid malnutrition is     recommended to provide nutrients necessary for a growth rate similar to the intrauterine     life.      For nearly one decade studying how to minimize in-hospital malnutrition in children born     prematurely, especially with gestational age less than 32 weeks or with birth weight below     1,500 g, called newborn very low birth weight (VLBW).      Embleton et al.demonstrated that with the current nutritional recommendations (protein     between 3.0 and 3.8 g / kg / day), the VLBW had malnutrition caused by protein and calorie     cumulative deficit.      Poor nutrition in the neonatal period can impair growth and neuromotor and cognitive     development after hospital discharge.      The investigators hypothesis is that VLBW subjected to aggressive nutrition with     protein-calorie high from birth until discharge, would present higher weight gain than the     VLBW infants who received routine diet of service, without producing adverse effects.   "
157898|NCT01217151|"     In the last years, there is a growing interest in the improvement of prognosis and shortening     of hospital length of stay in high-risk surgical patients. Several evidence-based protocols     (fast-track surgery) have been developed and implemented in some hospitals for this     purpose. Cardiovascular optimization through the so-called goal-directed therapy (GDT) is a     key element in these protocols. Previous studies in the literature use invasive monitors to     assess hemodynamics. The NICOM ™ is a non-invasive monitor validated in several clinical     scenarios. The aim of the present randomized, international, multi-center, open-label     clinical trial is to use a GDT protocol (including colloid boluses and vasoactive drug     infusion) based on data obtained from the NICOM™ device (cardiac index and mean arterial     pressure) to test the hypothesis that GDT is superior to standard practice in terms of     reduction in the incidence of perioperative complications and length of hospital stay in     high-risk major abdominal surgery patients (requiring ICU surveillance for, at least, 24     hours). As secondary objectives, time to first flatus, wound infection, anastomotic leaks and     mortality will be analysed. All patients will be followed from the day of surgery up to     hospital discharge (determined by a specialist surgeon not involved in the study) or death.   "
157899|NCT01217138|"     Part of the problems related with proper use of epinephrine autoinjector may be related with     the design of the autoinjector itself.The aim of the study is to investigate whether minor     modifications in the design of currently available epinephrine autoinjector ease its use and     abrogate common use errors.   "
157900|NCT01217125|"     The purpose of this study is to determine whether rapamycin is safe and effective in the     treatment of renal angiomyolipomas in patients with tuberousclerosis.   "
157901|NCT01217112|"     This 15-19 week study is being conducted by GW Pharma Ltd as a pilot study in order to     determine the efficacy and safety of two cannabinoids: GWP42004 and GWP42003 alone, or in     combination in patients with Type 2 diabetes. This is the first study to determine whether     the study medications have a positive benefit for subjects on their cholesterol levels, body     weight, liver fat content and other metabolic parameters compared with a placebo medication.   "
157902|NCT01217099|"     The purpose of this study is planned to investigate whether small doses of methylprednisolone     pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy     for refractory mycoplasma pneumoniae pneumonia(MPP) .   "
157903|NCT01217086|"     This is the trial to see how our product is similar to remicade by comparing the results of     blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or     parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving     adequate response to methotrexate alone up to week 30.   "
157904|NCT01217073|"     The purpose of this study is to assess the hypothesis that treatment with study medication     (omarigliptin; MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic     severity) compared with placebo, after 12 weeks of treatment. The study will evaluate 5     different doses of omarigliptin to identify which dose is the most effective in the treatment     of type 2 diabetes.   "
157905|NCT01217060|"     The goal of this clinical research study is to learn if giving chemotherapy and radiation     therapy before surgery for early-stage esophageal cancer can help to control the disease and     if so, for how long. The safety of this treatment will also be studied.   "
157906|NCT01217047|"     This research is being done to study the effect of Functional Electrical Stimulation (FES)     cycling on factors in blood and spinal cord in people with spinal cord injury (SCI).   "
157907|NCT01217034|"     The purpose of this study is to evaluate the safety and efficacy of the combination therapy     with Transcatheter Arterial Chemoembolization (TACE) and sorafenib compared to TACE alone in     patients with unresectable hepatocellular carcinoma (HCC) who are not candidates for surgical     resection or percutaneous ablation therapy.   "
157924|NCT01216800|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more     tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery     may kill any tumor cells that remain after surgery. It is not yet known whether     intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy is more     effective in decreasing hearing loss in patients undergoing radiation therapy for parotid     gland cancer.      PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to     see how well it works compared with 3-dimensional conformal radiation therapy in decreasing     hearing loss in patients who have undergone surgery for parotid tumors.   "
157908|NCT01217021|"     This research will look at how the brain may change in people with Alzheimer disease (AD).      The purpose of this research is to find out whether changes in the brain in people with     Alzheimer disease can be detected using a brain imaging test. Most people with Alzheimer     disease have changes in the brain that result in deposits of a protein called beta-amyloid.     In this study, the investigators will be using a radioactive drug, [18F]MNI-558 that binds to     beta-amyloid. This drug is experimental and has not been approved by the FDA. Brain imaging     using PET (positron emission tomography) will be done to see if the investigators can     evaluate the areas of beta-amyloid in the subjects with Alzheimer disease. The investigators     will compare these scans with those done in healthy normal volunteers. PET is a     brain-scanning test used in medicine and scientific research to see how the brain is working.     The PET imaging test used in this study is not being done for diagnostic purposes.   "
157912|NCT01216956|"     Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia.     Indeed Niacin decreases triglycerides (TG) and low density lipoprotein cholesterol (LDL-c)     but more importantly increases high density lipoprotein cholesterol (HDL-c). Although the     drug has been used for so long, its precise mechanism of action remains elusive. The aim of     this study was to characterise the metabolic changes induced by 8 week treatment with Niacin     in dyslipidemic, overweight patients. The importance of the inhibition of lipolysis on the     overall lipid effects of niacin will be studied. In order to get a very comprehensive view of     all metabolic activities of niacin, this study will investigate the potential effects of     niacin on Glucose metabolism, lipid and lipoprotein turnover, quantitative changes in     lipoproteins and key enzymes involved in lipid metabolism.   "
157913|NCT01216943|"     This study will investigate the safety and efficacy of Triple Combination Therapy     (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients     with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on     brimonidine/timolol ophthalmic solution.   "
157914|NCT01216930|"     A clinically applicably strategy for molecular screening for Lynch Syndrome has been     implemented in the Region of Southern Denmark.      Based on sequential analysis with immunohistochemistry and methylation analysis, patients     with possible hereditary colorectal cancer are identified. These patients are offered genetic     risk assessment and counselling.      The study hypothesis is that molecular screening will identify more patients with Lynch     Syndrome than the family history alone.      Prospective data collection is performed using established clinical databases.   "
157915|NCT01216917|"     The purpose of the present study is to evaluate the influence of the ageing process on muscle     quality. Therefore, muscle mass, muscle density and force-velocity characteristics are     measured after a 5-yr interval in older adults (65+).   "
157916|NCT01216904|"     The specific aims of this study are to examine whether treatment with transdermal nicotine     improves computer-based laboratory and clinical measures of impulsive and compulsive     behaviors in Parkinson's Disease subjects who have recently experienced an impulse control     disorder.   "
157917|NCT01216891|"     This study will assess the effectiveness of an experimental treatment intervention for     adolescents and adults who have experienced their first episode of psychosis during the past     two years.      The DUP sub-study will collect pathways to care information that will be used to inform the     development and pilot testing of strategies that aim to reduce DUP among individuals     experiencing a first episode of psychosis.   "
157918|NCT01216878|"     The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet     under fasted conditions.   "
157919|NCT01216865|"     The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of     treatment for diabetic foot is safe and effective in the management of diabetic foot     ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in     ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and     relieve the Sevier pain of ischemia.   "
157920|NCT01216852|"     The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet     under fasted conditions.   "
157921|NCT01216839|"     The purpose of this study is to determine the Everolimus aim response in children and     adolescents with refractory or relapsed Rhabdomyosarcoma and other soft tissue sarcomas   "
157922|NCT01216826|"     The purpose of this study is to determine the Everolimus aim response in children and     adolescents with refractory or relapsed osteosarcoma.      The aim response is defined as complete or partial response (according to RECIST criteria)     for at least 4 weeks, or stable disease for at least 12 weeks.   "
157923|NCT01216813|"     RATIONALE: Gathering information from patients who have undergone treatment for upper     gastrointestinal cancer or gynecological cancer may help doctors learn more about patients'     physical and psychosocial rehabilitation needs and plan the best treatment.      PURPOSE: This clinical trial is studying the physical and psychosocial rehabilitation needs     of patients after diagnosis and treatment of upper gastrointestinal cancer or gynecological     cancer.   "
157925|NCT01216787|"     This pilot phase II trial is studying how well RO4929097 works in treating patients with     stage III, or stage IV melanoma that can be removed by surgery. RO4929097 may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth   "
183123|NCT00238797|"     The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination     with radiotherapy on patients with glioblastoma multiforme.   "
157927|NCT01216761|"     Background: Contaminated blood cultures result in unnecessary antibiotic use, increased     length of stay, and additional laboratory tests, all of which increase healthcare costs.     While the optimal skin antisepsis agent for reducing blood culture contamination is not     known, the cost of various agents differs substantially.      Objective: To determine the relative rates of blood culture contamination for 3 skin     antisepsis interventions - 10% povidone iodine aqueous solution (PI), 2% iodine tincture (IT)     and 2% chlorhexidine gluconate in 70% isopropyl alcohol (CHG) - when used by dedicated     phlebotomy teams to obtain peripheral blood cultures in adult non-ICU medical and surgical     patients.   "
157928|NCT01216748|"     The purpose of this study was to determine if airway pH has an effect on albuterol-induced     vasodilation in the airway. Methods: Ten healthy volunteers performed the following     respiratory maneuvers: quiet breathing, hypocapnic hyperventilation, hypercapnic     hyperventilation, and eucapnic hyperventilation   "
157929|NCT01216735|"     The hypothesis underlying the proposed study is that the blunted endothelium-dependent     vasodilation seen in the airway of current smokers is also present in the brachial artery,     and that the same inhaled corticosteroid (ICS) treatment regime that reversed endothelial     function in the airway of current smokers will also restore endothelium-dependent relaxation     in the brachial artery. Non-smokers will be used as controls and will not receive any     intervention or treatment.   "
157930|NCT01216722|"     Resistance strengthening exercise will increase strength and functional activity greater than     ambulation in subjects post-liver transplantation.   "
157947|NCT01216267|"     The goal of this study is to compare several methods for measurement of Chromogranin A in     their ability to serve as a marker for disease activity in patients with neuroendocrine     tumors.      Further, in a subgroup, we will determine if taking a proton pump inhibitor affects     Chromogranin A levels.   "
157931|NCT01216709|"     Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with     cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant     foods are recommended for infants. However, the optimal iron dose and mode of delivery have     not yet been established. This is a concern as excessive iron intake may impair growth and     increase morbidity in iron-sufficient infants. Previous studies have suggested that     iron-fortified foods may have different effects than iron supplements. In this study, the     investigators will investigate whether the mode of iron administration (supplementation vs.     fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption,     iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.   "
157932|NCT01216462|"     The NET-SCA Registry has been designed to document and evaluate the clinical epidemiology and     current management of Acute Coronary Syndromes in the Lazio Region of Italy.   "
157933|NCT01216449|"     Antidepressant medications known as selective serotonin reuptake inhibitors (SSRIs) are most     commonly prescribed to treat depression and anxiety. How antidepressants work on the brain to     alter mood and behaviour is not well understood. This study will use a brain scanning     technique (functional magnetic resonance imaging) to examine how aging impacts brain     activation during emotional tasks after the administration of intravenous (IV) citalopram     (this is the only SSRI available in this form, and is well tolerated and safe in young and     old adults). The investigators will further determine what role genetic differences play in     this relationship. The investigators expect to see an increase in brain signal as the     concentration of IV citalopram increases. However, the investigators propose that the brain     signal in older adults will not be as strong as in younger adults. Furthermore, the     investigators expect that participants genetically predisposed to have fewer serotonin     transporters (the site of action of SSRIs) will show greater decreases in brain activation     with citalopram.   "
157934|NCT01216436|"     Our proposed study is designed to test the safety of a new vaccine against melanoma. The     induction of immune activity against cancers such as melanoma is a promising approach to     cancer treatment, but to date, only a few clinically significant immune responses have been     seen following vaccine therapy. This is an important problem, since there are very limited     treatment options for patients with metastatic melanoma (melanoma that has spread to lymph     nodes and organs).      Studies suggest that monoclonal antibodies (mAbs) that block inhibitory receptors on immune     cells can enhance the immune responses against cancer, but the intravenous injection of such     mAbs has caused severe side effects in animals and humans. In our laboratory, we have     developed a method to deliver mAbs and other proteins that block such inhibitory receptors     locally at the site where immune responses against melanoma proteins are stimulated by     vaccination, enhancing anti-melanoma immunity while avoiding the side-effects associated with     intravenous injection of these immune modulators. This is achieved by loading dendritic     cells, a type of immune cell, with RNA that encodes the immune modulator. The RNA-loaded     dendritic cells then make the immune modulatory proteins and release them locally. By mixing     these dendritic cells with additional dendritic cells loaded with melanoma proteins, the     immune modulators are released at the site where anti-melanoma immune cells are stimulated.      In this phase I trial, subjects with metastatic melanoma will undergo the process of     leukapheresis, in which white blood cells are removed from the body. Monocytes, a type of     immune cell, will then be purified from the white blood cells and cultured under conditions     that will change them into dendritic cells. Half of these dendritic cells are then loaded     with melanoma antigen RNA, which will lead to the production of melanoma antigen proteins     within the dendritic cells. The remaining half of the dendritic cells will be either     untreated or loaded with RNA encoding immune modulators so that these dendritic cells will     release immune modulators at the site of vaccination. These dendritic cells will be mixed     with the melanoma antigen-loaded dendritic cells and injected as a vaccine into lymph nodes.     Each subject will receive six weekly injections of their own dendritic cells. Safety and     toxicity will be closely monitored. In addition, immune responses against melanoma, as well     as clinical responses, will be assessed.   "
157935|NCT01216423|"     The cause of ischemic stroke remains frequently unknown. In patients with patent foramen     ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that     the main mechanism is paradoxical embolism and decided to look for clinically apparent and     silent cerebral embolism in patients with a recent pulmonary embolism.   "
157936|NCT01216410|"     The study investigates the incidence of intraoperative nausea and vomiting under spinal     anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.   "
157937|NCT01216397|"     The objective of the current study is to investigate the relative bioavailability of two     different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet     (FDC).   "
157938|NCT01216384|"     The primary objective of the current study is to investigate the safety and tolerability of     BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and     healthy Japanese male volunteers following single oral administration and multiple     administrations.   "
157939|NCT01216371|"     The aim ist to identify biomarkers in the blood, to indicate early response or early     treatment resistance.   "
157981|NCT01215825|"     It is well established that steroid use is a benefit in the treatment of chronic obstructive     pulmonary disease (COPD) with acute exacerbation (AE). But it is still debated about the     regimen and dosage of steroid use. From this retrospective review of medical charts, the     researchers investigated the therapeutic impact of various steroid dosages in COPD with AE.   "
158041|NCT01215045|"     Determine the clinical visual outcomes following bilateral implantation of the AcrySof ReSTOR     Aspheric Intraocular Lens (IOL) and to demonstrate what percentage of the subjects obtain     spectacle freedom.   "
157940|NCT01216358|"     The objectives of this prospective, descriptive study are to:        1. generate estimates of the incidence, prevalence, persistence, clinical impact and          attributable risk of migraine due to hormonal contraception (HC) use; and        2. identify predictive factors for clinically significant changes in headache attributable          to HC use.      The investigators hypothesize that:        1. Most women with pre-existing migraine will have no significant change from baseline          headache frequency or clinical impact attributable to HC at 3 months following          initiation; a minority will report clinically significant worsening or improvement        2. The incidence of headache and migraine in HC users will not be significantly different          from their incidence in NHC users        3. There will be identifiable risk factors for development or worsening of          headache/migraine in the minority of HC users where that occurs.   "
157941|NCT01216345|"     The aim of this prospective single-centre phase II study is to investigate the therapeutic     efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in     the palliative first line treatment of biliary tract cancer (BTC) patients.   "
157942|NCT01216332|"     This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent     inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with     Acute Lymphoblastic Leukemia.   "
157943|NCT01216319|"     Patients with a desire for nipple reconstruction following breast cancer and breast     reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing     the COOK Biodesign® Nipple Reconstruction Cylinder.   "
157944|NCT01216306|"     Obesity has been linked to the development of multiple cancers, and to poorer prognoses and     higher mortality rates for certain pediatric and adult cancers. Preventing obesity is     therefore a major strategy to prevent new cases of cancer and to decrease cancer related     morbidity and mortality. In the US, childhood obesity is on the rise. Since childhood obesity     strongly tracks into adulthood this epidemic among children greatly increases the risk of     obesity and presumably cancer in adulthood. As a result, preventing childhood obesity has     been selected as a major public health goal to reduce the risk and sequelae of obesity and     cancer in the US.      Moreover, television (TV) viewing has been identified as a major risk factor for childhood     obesity and US children spent more time watching TV than any other activity except sleep. TV     viewing contributes to excess weight gain by decreasing physical activity and increasing     caloric intake. The American Academy of Pediatrics (AAP) has issued national guidelines for     parents to limit their children's total entertainment media time to no more than 1 to 2 hours     of quality programming per day for children greater than 2 years of age. Low-income and     minority children were at greater risk for exceeding this recommendation.      Few published interventions have been successful in decreasing TV viewing in children and     only one was successful among preschool children. This intervention, Fit 5 Kids (i.e. fit     by age 5 years), was a preschool curriculum designed to decrease TV viewing via     age-appropriate lessons taught to the children by research staff. The curriculum also     included a take-home component consisting of a newsletter with ideas for parent (for this     grant, defined as the adult most responsible for the child's care, usually the mother) and     child activities that complemented the school lesson plans. Although most behavioral     interventions for preschoolers target parents rather than children, this curriculum was one     of the few successful interventions targeted directly at children. However, Fit 5 Kids was     not designed for or evaluated among Hispanic preschool children, the subpopulation of     preschool children most severely affected by obesity. Moreover, no published intervention has     successfully reduced both TV viewing and excess weight gain in any preschool population. In     order to fill this gap, the investigators propose to evaluate a culturally adapted Fit 5 Kids     TV reduction curriculum among Hispanic preschool children enrolled in the Head Start Program.      Fit 5 Kids is the TV reduction component of the Brocodile the Crocodile health promotion     program. The overall goal of Fit 5 Kids is to teach the preschoolers to decrease their TV     watching and encourage alternative activities such as family meals and active playtime. The     primary goal of this research plan will be to conduct a pilot group randomized controlled     trial evaluating the effectiveness of the adapted curriculum to reduce TV viewing and excess     weight gain in low income, Hispanic preschool children      To achieve the project goals, the investigators Specific Aim includes:      1. To successfully recruit forty-eight 3-5 year old Hispanic children from 4 Head Start     centers each year for 3 years and conduct a group randomized controlled study of the adapted     Fit 5 Kids curriculum to evaluate its effectiveness in reducing TV viewing and excess weight     gain in Hispanic preschool children.      The Primary Hypothesis to be tested includes:      H1. The culturally adapted Fit 5 Kids curriculum will reduce TV viewing and excess weight     gain among Hispanic preschool children.   "
157948|NCT01216254|"     The aim of this study is to assess the outcomes of breast conserving therapy operation     depending on the type of surgical tool used: classic electrocoagulation with higher operative     temperatures and high frequency electrocoagulation with lower operative temperatures. The     investigators would assess the pain levels, length and amount of the lymphatic secretion as     well as quality of life following breast conserving surgery.   "
157949|NCT01216241|"     The purpose of this study is to evaluate the benefits and side effects of daptomycin compared     to placebo for the treatment of neutropenic fever.   "
157950|NCT01216228|"     Health outcome studies should examine food patterns, because foods are consumed together and     nutrients are metabolized jointly. To examine associations between food patterns and markers     of systemic and vascular inflammation at baseline, in a population-based cohort in Malmö,     Sweden, and after 13 years of follow-up food pattern associations with CVD incidence.   "
157951|NCT01216215|"     Research Problem Asthma is one of the most common chronic diseases in the world that affects     approximately 300 million individuals worldwide. It is characterized by airway inflammation     and bronchoconstriction leading to airflow obstruction, however, the triggering factors     behind asthma development remains to be elucidated. Genetic risk factors have been suggested     to play a central role in asthma development. Twin studies supported a strong genetic     component to asthma, especially childhood asthma, with heritability estimates suggesting that     48-70% of asthma risk is attributed to genetic risk factors. Suggestive susceptibility genes     have been identified in European and American populations but not yet in the Middle East     including Saudi Arabia. Identified genes whether they are polymorphic variants of genes     encoding known pathophysiological molecules or novel genes identified by linkage or     genome-wide association studies (GWAS) are inconsistent in different populations thereby     adding to the need to undertake genetic studies on different ethnic populations and in     different countries. Here, the investigators hypothesize that polymorphic variation of novel     susceptibility genes form a major risk factor for asthma development, response to treatment     and progression in the Saudi population with strong diagnostic, prognostic and therapeutic     implications.      Research Significance Since the manifestation of complex inflammatory disorders with strong     heritability is complex involving genetic and environmental interaction, each ethnically     distinct population must be examined to know whether gene-disease association exists in that     population. The objectives of this proposal are to discover novel asthma susceptibility genes     in the Saudi population. A better understanding of the genetic mechanisms of asthma will     enhance our knowledge of its pathophysiology. Asthmatic patients with distinct genotypes     respond differently to asthma medications. Therefore, improvements in diagnostics and     pharmacogenetics may be the first clinical developments of these extensive studies. This     embraces the concept of asthma subphenotypes and stratified medicine where interventions are     targeted at those individuals who will best benefit from them with minimal side effects.     Physicians looking after asthmatic patients will be able to provide better medical service     tailored to those patients, as well as to identify Saudi people at high risk for the     development of asthma, especially the more severe forms of the disease.      Research Objectives The main objective of our proposal is to identify known and novel asthma     susceptibility genes in the Saudi population and to investigate their interaction with     clinical, environmental, and inflammatory factors contributing to asthma pathophysiology.      Research Methodology In this proposal, the investigators will investigate the genetic factors     contributing to asthma susceptibility by determining in Saudi population, the presence of     single nucleotide polymorphisms (SNPs) that have been previously reported from linkage and     GWAS in other populations. Whole genome DNA will also be scanned for novel SNPs of selected     asthma genes using microarrays. This will enable us to identify new SNPs that contribute to     the risk of asthma specifically in the Saudi population. In addition, the investigators will     cross-reference all genetic and immunological parameters with the corresponding clinical data     in order to elucidate the impact of certain genes, or their products (e.g. cytokines), on the     clinical manifestation of asthma.   "
157952|NCT01216202|"     Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal     cancer. For men there are theoretical reasons to believe that the treatment may effect     hormone levels, spermatogenesis, sexual function and wellbeing. To address these questions a     longitudinal observational study was initiated where patients can choose to take part in one,     two or three parts of the study. The three different parts are blood tests, questionnaires     and semen samples.   "
157953|NCT01216189|"     Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal     cancer.For women there are theoretical reasons to believe that the treatment may affect     hormone levels, sexual function and wellbeing. To address these questions a longitudinal     observational study was initiated where patients, before preoperative radiotherapy and one     year after surgery, take blood tests and answer two questionnaires.   "
157954|NCT01216176|"     The investigators propose to conduct a Phase I/randomized Phase II study design in order to     test the tolerability and efficacy of AZD0530 when used together with anastrozole in therapy     for ER+ and/or PR+, postmenopausal breast cancer. The Phase I pharmacokinetic (PK) cohort of     the study (cohort A) in postmenopausal women with metastatic breast cancer 2008-2009 showed     initial safety,tolerability and good bioavailability of both drugs and determined the doses     for use in the ongoing Phase II trial. In the randomized Phase II cohort of the study (cohort     B), postmenopausal women with newly diagnosed, previously untreated ER+, HER2 negative breast     cancer that is at least 2 cm or more in diameter by clinical exam or radiology will be     randomized to either neoadjuvant treatment with anastrozole plus placebo, or anastrozole in     combination with AZD0530. The Phase II cohort will permit extended assays of tolerability,     initial estimates of efficacy, and the investigation of molecular predictors of drug     efficacy.   "
157955|NCT01216163|"     This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen     formulation to placebo and acetaminophen in the treatment of post-surgical dental pain     following wisdom tooth (third molar) removal.   "
157978|NCT01215864|"     This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific inhibitor     of the enzyme choline kinase alpha, in patients with advanced solid tumors. The objectives of     this study are to evaluate the safety of the drug and to determine the maximum tolerated dose     and appropriate dose for phase II studies. Secondary objectives are to measure the efficacy     of TCD-717; and in a substudy to be conducted in the MTD confirmation cohort only, to     evaluate the potential correlation between the levels of tumor choline and tumor response to     the choline kinase alpha inhibitor, TCD-717, using magnetic resonance spectroscopy.     Pharmacokinetics analysis will be performed on patients enrolled in the maximum tolerated     dose confirmation cohort.   "
158081|NCT01214798|"     Traumatic sesamoid displacement of the first metacarpophalangeal joint can affect thumb     function.   "
157956|NCT01216150|"     Aims Aspirin combined with clopidogrel is the treatment of choice for acute coronary     syndromes. Although the maintenance of aspirin until surgery does not affect postoperative     bleeding after coronary artery bypass graft (CABG) surgery, the latter may be dramatically     increased when clopidogrel is continued over a period of 5 days preoperatively. Methods and     results: This prospective observational study will include 136 consecutive patients scheduled     for first-time CABG. Postoperative bleeding and blood transfusion requirements will be     compared (non inferiority)between patients pretreated during a period of 5 days prior surgery     by either aspirin alone or combined with clopidogrel. Tranexamic acid will be systematically     used in all these patients considered as high risk for bleeding.      In concusion, this study has to to test the hypothesis that with tranexamic acid also,     bleeding in the aspirin + clopidogrel group is not 25% more important than in the aspirin     alone group after CABG surgery, according to the previous study using aprotinin.   "
157957|NCT01216137|"     The purpose of this study was to test the feasibility and effectiveness of a novel exercise     intervention for individuals who live with multiple sclerosis (MS).   "
157958|NCT01216124|"     The 10%-15% of breast carcinomas known to be 'triple negative (TN)' (not expressing HRs and     not exhibiting overexpression Her2) constitutes 85% of all basal-like tumors, because it is     based on three standard immunohistochemical biomarkers.      In clinical routine, Docetaxel was widely indicated as first-line therapy for breast cancer     patients in adjuvant or neoadjuvant settings. Oxaliplatin,     trans-1-diaminocyclohexane-platinum, may offer advantages over other platinum agents.     Oxaliplatin promotes formation of DNA adducts, preventing DNA replication and transcription     and ultimately causing apoptosis. Oxaliplatin was more potent than cisplatin and the     Oxaliplatin-based regimen was active for the patients of lung cancer, colorectal cancer and     ect. TNBC patients were more sensitive to platinum-based chemotherapy regimens according to     the results of some retrospective studies. There was no report about Oxaliplatin in the     chemotherapy setting for breast cancer patients.      The investigators hypothesized that using Oxaliplatin adding to docetaxel would be feasible     and active in patients with TNLABC because in vitro findings suggest synergism between the     agents. This study was designed to investigate the efficacy and toxicity of oxaliplatin-based     regimen as a neoadjuvant chemotherapy setting in triple negative local advanced breast cancer     patients   "
158024|NCT01215266|"     The purpose of this study is to evaluate the use of Sorafenib additionally to gemcitabine and     cisplatin in bladder cancer.   "
158073|NCT01213641|"     The purpose of this observational study is to collect additional information regarding     long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical     practice.   "
157959|NCT01216111|"     Previous studies in Western country show that triple-negative breast cancer has aggressive     clinical and pathological features compared with non-triple negative breast cancer, including     onset at a young age, advanced clinical stage, high histologic and nuclear grade and more     distant recurrence.      According to the characteristics of triple negative breast tumor, the TNBC patients can     benefit neither from hormonal therapies nor from target therapies against Her2 receptors. The     only systemic therapy currently available is chemotherapy, and prognosis remains poor. It     becomes more and more important to investigate the sensitive chemotherapy regimen for triple     negative patients.      Cisplatin-based regimen was active for the patients of lung cancer, colorectal cancer and     ect. Triple negative breast cancer patients were more sensitive to platinum-based     chemotherapy regimens according to the results of some retrospective studies.      The investigators hypothesized that paclitaxel combined with cisplatin is more sensitive to     triple negative breast cancer compared with CEF followed by docetaxel.   "
157960|NCT01216098|"     The purpose of this study is to evaluate the impact of doula support on childbirth outcomes     of women who are eligible for and attempting to have a Vaginal Birth After Cesarean (VBAC).     Doulas are paraprofessionals who provide women with continuous physical and emotional support     throughout the course of labour. They also conduct home visits in the prenatal and postpartum     periods in order to provide women with information on childbirth-related topics and     breastfeeding support. They do not perform clinical tasks. Their value lies in the     psycho-social care that they provide. It is hypothesized that women who receive doula support     alongside standard care will have a lower rate of epidural analgesia use and greater cervical     dilation at time of epidural administration, as compared to those who receive standard care     alone.   "
157961|NCT01216085|"     This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of     high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60     months after Glivec administration will be described.   "
157962|NCT01216072|"     The purpose of this study is to evaluate the change in patient-reported outcomes, physician     assessment of a change as well as safety and tolerability in patients with Relapsing Forms of     Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of     two treatment arms: fingolimod vs. standard of care DMT.   "
157963|NCT01216059|"     Atopic dermatitis is a common problem faced by patients of all ages and backgrounds.     Treatment regimens and specific therapies may be time consuming and multiple studies have     documented a parallel decrease in compliance as time after an office visit increases. The     adolescent population is an extremely challenging sub-group of patients in terms of complying     with a treatment regimen. Not only are they striving for independence and thus lacking     supervision of a regimen by a parent, but their complex thinking skills are immature, leading     to forgetful behavior. By introducing a reminder system for these vulnerable patients that is     easily incorporated into their daily lives, the investigators propose that patients will have     better compliance at applying their medication and thus improving their atopic dermatitis.     Text-messaging via cell phones has become very popular among teenagers and adults and     provides a non-obtrusive method of sending a treatment reminder.   "
157964|NCT01216046|"     The purpose of this study is to assess the pharmacokinetics and safety of VX-809 and VX-770     alone and in combination in healthy subjects.   "
157965|NCT01216033|"     The aim is to study if breast cancer metastases accumulate the newly developed HER2 binding     molecule 111-In-ABY025 and if that shows whether the metastases express HER2.   "
157979|NCT01215851|"     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral     administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with     pyrazinamide and PA-824 with moxifloxacin and pyrazinamide, as determined by the rate of     change of log CFU in sputum over the time period Day 0-14 in participants with smear positive     pulmonary tuberculosis (TB). A control group will receive standard treatment.   "
157980|NCT01215838|"     The purpose of this study is to determine if a new magnetic resonance (MR) protocol is better     at diagnosing liver lesions.   "
157966|NCT01216020|"     BACKGROUND:      Concomitant radiotherapy and cisplatin (CDDP) based chemotherapy is the standard treatment     for LA-NHSCC. This combined modality treatment is linked with considerable acute local and     systemic toxicity.EGFR is overexpressed in 90-100% of the HNSCC cases and is considered an     unfavourable prognostic marker. EGFR costitutive activation is linked with HNSCC     pathogenesis.      Cetuximab is a monoclonal anti-EGFR antibody blocking the activation of the receptor and     signal transduction. Cetuximab combined with radiotherapy is superior to radiotherapy only in     the treatment of LA-HNSCC and is characterized by an acceptable toxicity profile.      RATIONALE:      A direct comparison between concomitant chemoradiotherapy with Cisplatin and the concomitant     treatment with radiotherapy associated to cetuximab does not exist.      STUDY DESIGN:      Arm A: Radical radiotherapy (doses and volumes) concomitant with chemotherapy with Cisplatin     (40 mg/mq/week) Arm B: Radical radiotherapy (doses and volumes) concomitant with therapy with     the monoclonal antibody Cetuximab (400 mg/m2 [loading dose] and subsequently 250 mg     /m2/week)   "
157967|NCT01216007|"     The objective of this pilot study is to compare plasma [bupivacaine] between two groups of     paediatric patients under general anaesthesia who will all receive regional caudal     anaesthesia with bupivacaine: group 1 will receive TIVA and group 2 will receive a volatile     anaesthetic.   "
157968|NCT01215994|"     The purpose of the present study is to evaluate bias, precision and accuracy of new cystatin     C and creatinine based equations for GFR estimation compared with 51Cr-EDTA (chromium-51     labeled ethylenediamine tetraacetic acid) measured GFR in patients with diabetes.   "
157969|NCT01215981|"     Study Design:      This is a randomized, single center study to evaluate immune responses to the seasonal     influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who     receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy     adult volunteers will be recruited as controls to confirm immune response to a single     influenza vaccine.   "
158025|NCT01215253|"     The purpose of the study is to see how effective a drug called ranolazine is in reducing the     risk of ventricular arrhythmia and death in people with implantable     cardioverter-defibrillators (ICDs). This drug will be used with standard medications that is     routinely prescribed in enrolled patients.   "
157970|NCT01215968|"     The primary purpose of this Study is to help answer the following research question(s).        -  How does LY2189265 affect gastric emptying (the speed at which food and drink leaves the          stomach) in patients with Type 2 diabetes?        -  How does LY2189265 affect how the body handles metformin (a drug used to treat Type 2          diabetes)?        -  Is LY2189265 safe and are any side effects associated with it?      The study will be participant-blind in Week 1, and participant- and investigator-blind from     Week 2 through Week 5.      Each participant will receive placebo on Week 1 and once-weekly doses of LY2189265 or Placebo     on Weeks 2 to 5. Participants taking metformin for the treatment of Type 2 Diabetes Mellitus     (T2DM) will continue taking metformin as part of the study.   "
157971|NCT01215955|"     Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature.     The purpose of this study is to evaluate the efficacy and safety of two approaches to     escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving     adequate glycemic control on basal insulin.   "
157972|NCT01215942|"     The primary purpose of this study is to help answer if LY2127399 is safe and effective during     long-term treatment in patients with Rheumatoid Arthritis.      This study is comprised of 2 periods:      Period 1 - unblinded treatment for up to 240 weeks for patients who enroll from Study     H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks     for patients who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).      Period 2 - 48 week post treatment follow up   "
157973|NCT01215929|"     Methamphetamine use is very common in the US and is associated with serious medical and     psychiatric problems. There has also been a significant increase in the number of patients     entering treatment for methamphetamine dependence, however, no pharmacologic treatment has     been identified as effective in treating methamphetamine addiction. Given that withdrawal     from methamphetamine is thought to contribute to relapse to methamphetamine use during early     treatment, it is important to examine potential pharmacologic agents for alleviating     withdrawal. Thus, this study is designed to study methamphetamine withdrawal in humans. To     this end, 30 methamphetamine dependent participants (ages 18-65 years) will be entered into a     4-week residential study. Urine samples will be obtained at baseline to ensure recent     methamphetamine use. Intake assessments will include cognitive testing, standardized     assessment of depression and anxiety, profile of mood states, methamphetamine selective     severity assessment, methamphetamine withdrawal assessment, sleep quality and quantity, a     pre-attentional measure and attentional measure. Upon admission to the residential facility,     all study participants will be started on (20-30mg) long acting amphetamine/d-amphetamine and     stabilized over the first 5 days. After stabilization participants will be randomized based     on sex, amphetamine withdrawal questionnaire score, and methamphetamine selective severity     assessment score to either continued treatment with amphetamine/d-amphetamine or placebo for     2 weeks. All subjects will then be placed on placebo for the last 7 days. The investigators     hypothesis is that stopping amphetamine administration in methamphetamine dependent     individuals will negatively impact mood, sleep and cognitive function in a time-limited     fashion that may differ depending upon the measure and that attentional, but not     pre-attentional, measures will be adversely affected in those receiving placebo compared to     those maintained on amphetamine.   "
157974|NCT01215916|"     The primary objective of this study is to determine the MTD regimen for the combination     therapy of LY573636 and pemetrexed that may be safely administered to patients with a solid     tumor that is not amenable to curative therapy.   "
157975|NCT01215903|"     The present study was conducted to test whether a fish gelatin supplement combined with an     omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects     on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure,     lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant men     and women. The investigators hypothesis is that fish gelatin improves insulin sensitivity,     glucose tolerance, lipid profile and reduces inflammation in obese or overweight     insulin-resistant men and women.   "
157976|NCT01215890|"     The occurrence of bone loss in Crohn's disease patients is an important clinical problem for     both patients with and without active disease. While therapy does exist for treatment and     prevention of low BMD, evidence of its efficacy in Crohn's disease patients is lacking. The     current standard of therapy in Canada for the treatment of osteoporosis is etidronate, with     adequate calcium and vitamin D supplementation.      The primary objective of the study is to assess the efficacy of risedronate, compared to     placebo, administered once-weekly, in the treatment of low BMD of the spine and hip in     patients with Crohn's disease at 12 months, based on an intention-to-treat analysis.   "
157977|NCT01215877|"     The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination     with other chemotherapy agents are active in patients with advanced and metastatic bladder     cancer, and agents of this class are a promising treatment option for some patients.      Tesetaxel is an orally administered taxane that is in development as treatment for subjects     with advanced cancers. This study is being conducted to determine the efficacy and safety of     tesetaxel administered to patients previously treated with chemotherapy for progressive     metastatic transitional cell carcinoma of the urothelium.   "
157982|NCT01215812|"     The aim of this study was to analyze victims, assailants, assaults, evidentiary examinations     and treatment characteristics of cases of sexual assault sought emergency care at Far Eastern     Memorial Hospital、National Cheng Kung University Hospital、Taoyuan General Hospital,     Department of Health, Executive Tuan, R.O.C.、National Taiwan University Hospital Yun-Lin     Branch、Hospital and National Taiwan University Hospital.   "
157983|NCT01215799|"     This is a Phase II open-label study evaluating the preliminary efficacy and safety of     bafetinib administered as 240 mg orally twice daily in subjects with Hormone Refractory     Prostate Cancer.   "
157984|NCT01215786|"     This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3     doses of AGN-207281 based on an ongoing review of data during the study period compared with     timolol ophthalmic solution or placebo in patients with ocular hypertension or primary     open-angle glaucoma.   "
157985|NCT01215773|"     The main objectives of the multiple dose study are to investigate the safety, tolerability     pharmacokinetics of BI 671800 HEA in healthy male and female volunteers following multiple     oral administration of BI 671800   "
157986|NCT01215760|"     Objectives: To develop a protocol for early treatment using sensory reeducation through the     mirror after surgical reconstruction of the median nerve and / or ulnar hand, and its     comparison with the evolution of the return of skin sensitivity after a not early     rehabilitation which will be conducted by physiotherapists, with blinding of the evaluators.   "
157987|NCT01215747|"     The primary purpose of this study is to assess the efficacy and safety of treatment with     Kiacta in adult patients with AA Amyloidosis.   "
158054|NCT01214863|"     This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric     Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.   "
157988|NCT01215734|"     Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT)     recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be     significantly different from adult stem cell transplant recipients receiving standard dose     (SD) TIV.        -  Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza          vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic          stem cell transplant recipients.      Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent     influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody     titers to influenza antigens compared to those who receive standard dose trivalent influenza     vaccine.        -  Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell          transplant recipients influenza virus antigens included in trivalent influenza vaccine          after high dose or standard dose trivalent influenza vaccine.   "
157989|NCT01215721|"     Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading     cause of death from cancer in men. Radical prostatectomy is one of the treatment options     available for organ-confined disease. Over 100,000 radical prostatectomies cases (total     removal of the cancerous prostate by surgery) are performed in the United States yearly.     Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life     (QOL) scores due in part due to a postoperative incontinence which may require the use of     multiple urinary pads per day. Many of these men also report debilitating irritative voiding     symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction     scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients     symptoms may persist for longer periods.      Our recent published findings suggest that instability in the bladder muscle is likely an     underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle' instability     results in excess contractions of the urinary bladder ('urgency to urinate'), and can result     in the feeling of needing to urinate more frequently. Consistent with this hypothesis of     detrusor muscle instability, men with postoperative dribbling had more complaints with     urgency, frequency and bother scores when queried with validated questionnaires. We suspect     that a transient bladder muscle contraction may overcome the urinary sphincter valve     resistance and result in the patient's dribbling of urine.      By treating the bladder muscle instability, we expect improved postoperative continence and     improved quality of life in patients after undergoing surgery for total removal of a     cancerous prostate. This pilot study will assess the statistical requirements for the number     of subjects needed for a fully 'powered' randomized prospective study to fully evaluate     whether medications such as solifenacin significantly improve patients' quality of urinary     life and improve postoperative urinary incontinence after surgery.      *This study has been modified from the original protocol with the clinicaltrials.gov ID:     NCT00581061.   "
157990|NCT01215708|"     The investigators objective is to study if some drugs can improve the success rate of     extracorporeal shockwave lithotripsy for renal stones.   "
157991|NCT01215695|"     We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with     general anesthesia including endotracheal intubation. Patients qualify for the trial if they     are considered a difficult airway case as determined by measurement of common predictive     indices for difficult intubation (see inclusion criteria). All patients will be intubated     with a GVL. Patients will be randomly assigned to either having their ETT placed with use of     a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a     flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The     randomization will be stratified as to whether patients are categorized as predicted     difficult airway or have an immobilized cervical spine (C-collar in place).   "
157992|NCT01215682|"     Background: The medical and economic burden of upper respiratory tract infections (URTIs) is     extremely high, while prevention and treatment options are limited. Therefore, there is a     constant need for new methods in order to significantly decrease such morbidity. Extensive     evidence shows that vitamin D is associated with respiratory health, including in the     prevention and treatment of URTIs. Competitive swimmers have a high prevalence of URTIs, and     can serve as a model for research in this field.      The study hypothesis is that vitamin D supplementation to young swimmers with low vitamin D     levels will reduce the frequency, length, and severity of URTIs and their accompanying     functional impairment, while improving cellular immune function and physical function.      Methods: After screening 100 competitive adolescent swimmers to obtain ~60 with low serum     levels of vitamin D, this study group will be randomized to receive either vitamin D     supplementation (2000 IU/d) or placebo, given in a double blinded fashion for three months.     Participants will fill a daily questionnaire regarding frequency, length and severity of     URTIs symptoms and functional impairment. Blood will be drawn to evaluate changes in vitamin     D status (25(OH)D) and immune function among study participants at the beginning of the study     and after supplementation. Physical function on land and in water will also be assessed.      Expected results: Increase in serum 25(OH)D levels following supplementation will     significantly decrease the frequency, length and severity of URTI's and their functional     impairment, while enhancing the cellular immune system function and physical capacity.   "
158093|NCT01214642|"     This study is being conducted to determine the safety of LY2523355 for the treatment of     advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).   "
157993|NCT01215669|"     This study is designed to assess the immunogenicity and safety of the 2010-2011 NH season     formulation of intradermal (ID) influenza vaccine as part of a post registration commitment.      Objectives:        -  For all groups, to evaluate compliance, in terms of immunogenicity, of the corresponding          strength of the intradermal (ID) or intramuscular (IM) influenza vaccine Northern          Hemisphere (NH) 2010 2011 formulation with the requirements of the Committee for Human          Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96        -  For all groups, to describe the safety   "
157994|NCT01215656|"     The objective of the study is to evaluate the effects of a follow on formula containing the     human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old     infants.   "
157995|NCT01215643|"     The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with     either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard     of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and     3. In addition, triple therapy with DEB025 plus standard of care will be applied to     participants not achieving rapid viral response (RVR) in the different arms.   "
157996|NCT01215630|"     The primary aim is to study the relationship between vascular function, cardiovascular     fitness and age in healthy subjects. Individuals with the highest cardiovascular fitness will     have the greatest arterial inflow independent of age.   "
157997|NCT01215617|"     The purpose of this study is to investigate if 3 months of interval training improves     obstructive sleep apnea in obese patients diagnosed with moderate to severe obstructive sleep     apnea. The working hypothesis is that 3 months of 3 weekly aerobic interval training sessions     improve obstructive sleep apnea and sleep quality in obese patients.   "
157998|NCT01215604|"     The investigators propose that the translation initiation factors eIF4E and eIF4GI may be     involved in resolution of acute inflammation (regardless of age). Furthermore, the     investigators suggest that differences in translation initiation factors state of activation     may contribute to inflammation. Finally, the investigators hypothesize that differences in     translation initiation factors state of activation may underlie the immune compromised state     of the very elderly affording additional explanation for the heightened morbidity from     infection in this group.      In the current study the investigators aim to test these hypotheses by measuring the levels     of eIF4E and eIF4G, their regulators, and targets in elderly (65-84yrs) and very elderly     (85yrs<) patients hospitalized at Meir hospital for acute infection and after their recovery     (detailed in study design).   "
157999|NCT01215591|"     To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or     less   "
158000|NCT01215578|"     The purpose of this study is to identify predictive molecular markers of response to     continuous daily sunitinib at dose of 37.5 mg used in patients with poorly-differentiated     Advanced/Inoperable NEURO-Endocrine Tumors.      Hypothesis:        -  To distinguish molecular markers based on their expression at the initial biopsy, their          detection by proteomic analysis and demonstrating that tumor or vascular cells are          straightaway sensitive to sunitinib (markers sensitivity).        -  The presence of these markers at the initial biopsy predict the sensitivity to          sunitinib(Positive predictive value of markers)   "
158001|NCT01215565|"     The purpose of this study is to evaluate the antitumor activity of sunitinib in patients with     advanced/inoperable fibrolamellar hepatocellular carcinoma.      Rationale: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor   "
158002|NCT01215552|"     This Positron Emission Tomography (PET) imaging study is designed to explore the relationship     between HT-0712 dose level and inhibition of brain phosphodiesterase-4 activity, in order to     optimize the dosage regimens utilized in subsequent trials.   "
158003|NCT01215539|"     The purpose of this study is to determine whether panitumumab in combination with     capecitabine/oxaliplatin are effective as first-line treatment in wild-type k-ras, metastatic     colorectal cancer patients.   "
158004|NCT01215526|"     Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed     for a maximum of 3 years to estimate the progression free survival. Data on testosteron     levels, QoL and LUTS will be collected if this information is available. Safety information     (adverse events) will be collected.   "
158005|NCT01215513|"     This is an open-label, multi-centre single arm trial to investigate long-term safety and     tolerability of degarelix in Korean patients with prostate cancer.   "
158006|NCT01215500|"     Patients with metastatic cancer are generally treated with chemotherapy, which has improved     median survival compared to best supportive care. Despite this, patients continue to have     persistent disease at sites that were initially involved with cancer. Radiation therapy is an     effective modality for treating localized cancer but generally has been only used for     palliation of symptoms once a patient develops metastatic disease. Since patients often have     persistent disease after chemotherapy, the goal of this trial is to use increasing doses of     radiation therapy to all sites of involved disease in order to determine the safety and     efficacy of hypofractionated radiation therapy.      The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities,     and recommended phase 2 dose of hypofractionated radiation therapy.   "
158019|NCT01215331|"     Gestational diabetes mellitus takes place in 2 steps. First, it is the consequence of insulin     resistance due to the modifications of the pregnancy hormonal environment, and second, of the     deficiency of the beta cells of the pancreas to respond by a sufficient insulin secretion.     This physiopathology is closely connected to the one of type 2 diabetes. Insulin, indeed, can     remedy these 2 etiologies, but it is logical to think about using oral hypoglycemic agents     which have been created to treat them: they are a natural choice because they improve insulin     sensitivity (metformin, a biguanide) or insulin secretion (glyburide, a sulfonylurea). It     also seems natural to use them in combination, glyburide being added to metformin if needed.      OUR GENERAL RESEARCH HYPOTHESIS IS THAT: in pregnant women with gestational diabetes     mellitus, using both oral hypoglycemic agents (glyburide added to metformin if needed) allows     a glycemic control comparable to the one obtained with insulin, but with a better     acceptability from women and a better health status, diabetes treatment satisfaction and     well-being and a reduced postnatal depression.   "
158094|NCT01214629|"     This study is being conducted to determine the safety of LY2523355 for the treatment of     advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).   "
158007|NCT01215487|"     Imatinib (IM) is first-line treatment for patients with newly diagnosed CML in chronic phase.     The drug is associated with high rates of cytogenetic responses with minimal toxicity in     approximately 80% of patients. In 20% of patients however, the disease is either initially     unresponsive to IM (Imatinib), resistance develops within a few months, or blast crisis     occurs early and unexpectedly following an initial response. An increasing body of clinical     evidence indicates that single agent molecularly targeted therapy (as in Gleevec/Imatinib)     will not cure most patients with CML, as molecular remissions are rare. There is currently no     clinically useful predictive tests to identify AT DIAGNOSIS those patients who are destined     to be IM failures. The authors of this study have recently demonstrated that CML     stem/progenitor cells are biologically insensitive to IM and are also genetically unstable     and rapidly generate IM-resistant mutants in vitro and in vivo. The team recently discovered     that the CD34 stem/progenitor cells of newly diagnosed CML patients who subsequently fail to     respond to IM treatment show a reduced response to IM and a higher frequency of BCR-ABL     mutations by comparison of 14 IM non-responders with 11 IM-responders. If this finding can be     validated in a larger prospective cohort of patients, this predictive test could be used to     more rationally design treatment plans with early addition of alternative therapies ie:     Dasatinib or combination therapies for patients according to their individual risk profiles.      Hypothesis:      The clinical response of newly diagnosed chronic phase CML patients to IM can be predicted by     certain biological properties of their CD34 stem/progenitor cells which are variable among     patients.   "
158055|NCT01214850|"     The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal     vaccines on carriage of Neisseria meningitidis in a young adult population.   "
158008|NCT01215474|"     While current mutational analyses comprise exons 19 and 21 in which the majority of     EGFR-mutations occur, this study aims at investigating the relevance of exon 18 and 20     mutations. Therefore, the investigators analyse 500 routine tumor samples with respect to the     above mentioned exons and correlate the results to the clinical outcome. This approach will     enable us to potentially identify patients that might in the future benefit from targeted     therapy (EGFR-inhibition).   "
158009|NCT01215461|"     The purpose of this study is to better understand the factors associated with mortality and     identify potentially preventable causes of death in neonates who die after receiving health     care. As a result, an improved neonatal mortality classification system may be defined.   "
158010|NCT01215448|"     This study is aimed to study the impact of wheatgrass juice and lifestyle recommendations     (diet, physical activity and breathing exercises) on the well being, fatigue and     hematological parameters of chemotherapy-naive patients with no evidence for symptoms of     active oncological disease.The researchers hypothesize that both wheatgrass juice and     lifestyle recommendations can improve patient's well-being during chemotherapy.   "
158011|NCT01215435|"     This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control     when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified     treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic     drugs) alone.   "
158012|NCT01215422|"     There are two new instruments on the market that anesthesiologists use when putting a     breathing tube into the lungs of patients. The purpose of this study is to see how easily     anesthesiologists can learn to use them in children.   "
158013|NCT01215409|"     In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study,     data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile     dysfunction. The general objectives are to evaluate the product safety (primarily by     recording adverse events), efficacy and patient acceptance.   "
158014|NCT01215396|"     A number of studies have shown that ingestion of crystalline amino acids, in particular     branched chain amino acids (BCAA) can affect endurance performance, markers of muscle damage,     and possibly mental focus. It seems that the longer and lower intensity events are affected     more by consumption of BCAA. This study will test the hypothesis that BCAA availability     limits central fatigue (the feeling of tiredness). While various aspects of performance have     been tested no study to date has tested multiple exercise, muscular, and mental performance     aspects in a single study. Thus, the overall purpose of this study is to determine whether an     amino acid supplement changes the mental and physical response to prolonged exercise versus a     placebo (carbohydrate drink).      This nutritional supplement could be useful on two levels. Improved mental focus and     endurance performance and decreased central fatigue and muscle soreness could be valuable for     enhancing athlete performance. Similarly, decreased central fatigue and muscle soreness may     increase the willingness of the general public to exercise which could translate into     decreased health risks and increased health benefits.   "
158015|NCT01215383|"     Background:      Among individuals with schizophrenia, there is an increased prevalence of obesity,     dyslipidemia ,diabetes mellitus and related conditions such as cardiovascular disease. People     with severe mental illnesses, such as schizophrenia, depression or bipolar disorder, have     worse physical health and reduced life expectancy compared to the general population. Number     of epidemiological studies of patients with schizophrenia have documented a higher incidence     of cardiovascular disease than in the general population, and patients with schizophrenia may     be at an elevated risk for cardiovascular disease even in the absence of antipsychotic     treatment.      Affinity for the H1 receptor is most closely linked to increased weight gain, although     affinity for D2, 5-HT1A, 5-HT2C and a2-receptors may also be involved. Drug affinity for the     H1, M3 and 5-HT2C receptors is correlated with an increased risk of diabetes.      High-density lipoprotein cholesterol (HDL-C) concentration in the blood is independently and     inversely associated with an increased risk of cardiovascular disease(CVD). However many     patients with 'normal' or even 'elevated' plasma HDL experience clinical events. HDL may not     always be atheroprotective and in some conditions, it paradoxically enhances the process of     atherosclerosis. In addition to its role in reverse cholesterol transport, HDL shows many     other protective properties towards atherosclerosis. HDL inhibits the chemotaxis of monocytes     , prevents endothelial dysfunction and apoptosis, prohibit slow-density lipoprotein (LDL )     oxidation, and stimulates the proliferation of endothelial cells and smooth muscle cells.     These anti-inﬂammatory, antioxidative, antiaggregatory, anti-coagulant, and pro-ﬁbrinolytic     activities are exerted by different components of HDL      Aim of the study:      To investigate the functional properties of HDL in psychiatric patients before and during     antipsychotic therapy.      Patients and methods:      The blood will be drawn at baseline before the initiation of antipsychotic drugs and 2 months     under the antipsychotic treatment.      Study procedures:      Full lipid profile including triglycerides, LDL-C, Total cholesterol, HDL-cholesterol, apo     AI, apoAII and apoB100.      Serum Paraoxanase Activity      LDL oxidation and resistance to oxidation (measured by conjugated diens formation during     incubation in the presence of copper).      HDL composition: total and unesterified cholesterol, triglycerides and phospholipids, TBARS     content before and after exposure to AAPH as a major indicator of oxidative stress, PON     activity using phenylacetate as a substrate, apoA1and PAF.      Serum parameters e.g. Diacyl glycerol acyltransferase activity, free ApoA1 and LCAT activity.      3 [H]-Cholesterol efflux will be measured by incubating J744 macrophages with serum.     Radioactivity will measured by β counter in the cell lysate and the medium.      Statistical methods:      One-way AVOVA and Student's t-test for paired samples will be used for comparison of multiple     groups and paired samples, respectively. p<0.05 will be considered significant.   "
158016|NCT01215370|"     The main objective is to investigate the postprandial effect of arginine-rich protein (i.e.     pea-protein) on metabolic control, inflammation and endothelial function after a high-fat     meal in subjects with characteristics of the metabolic syndrome.   "
158017|NCT01215357|"     This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble     in patients diagnosed with Pathological Gambling.   "
158018|NCT01215344|"     The purpose of this study is to study the MRD status after VELCADE based induction therapy     (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in     patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on     MRD status post‐transplant. Our hypothesis is that MRD‐status will continue to increase     significantly at 3 months post‐transplant and will validate that HDC and ASCT needs to be     performed even when patients have achieved major response after induction therapy with novel     agents.   "
158020|NCT01215318|"     The etiology of FDG uptake in vaginal tampons during PET/CT examinations remains unclear and     can potentially impaire image interpretation.      The aim of this study is to determine the etiology of this artefact and devine potential ways     how to prevent it.   "
158036|NCT01215110|"     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral     administration of TMC207 at multiple doses as determined by the rate of change of log10     colony forming units (CFU) per ml sputum over the time period Day 7-14 in participants with     smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.   "
158037|NCT01215097|"     In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of     Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of     treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient     glycaemic control.   "
158021|NCT01215305|"     The present study has been designed to provide current data on GERD prevalence in several     regional areas of Greece outside the two major urban centres (Athens and Thessaloniki), to     measure the treatment response in GERD patients, and to assess the correlations between the     two methods of diagnosing GERD, i.e. reporting of symptoms by the patient to the physician     and completion of the GerdQ questionnaire by the patient. Additionally, this study aims to     provide data on the prevalence of extraesophageal symptoms in GERD patients in Greece. The     XQS questionnaire will be applied for the identification of these patients and the assessment     of the extraesophageal disease burden (frequency and intensity/severity). Finally, an     association between the GerdQ and XQS scores will be attempted.   "
158022|NCT01215292|"     The purpose of this research study is to determine how much male hormone, testosterone, is     necessary to maintain sperm production in the testis. This knowledge will be used to help in     the development of a safe male hormonal contraception.      Specific Aims:        1. to determine if ketoconazole plus acyline will suppress intratesticular          testosterone(ITT) to a greater degree than acyline alone.        2. to determine if dutasteride plus acyline will suppress intratesticular          dihydrotestosterone (IT-DHT) to a greater degree than acyline alone.        3. to determine if anastrazole plus acyline will suppress intratesticular estradiol(IT-E2)          to a greater degree than acyline alone.   "
158023|NCT01215279|"     The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients     with chronic obstructive pulmonary disease.   "
158026|NCT01215240|"     Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart     surgeries before they turn three years of age. The first surgery typically happens in the     first two weeks of life. After this operation, babies come back to the intensive care unit     with their chests open. Babies who have heart surgery retain body water after surgery and     this extra water slows recovery. Surgeons cannot close the chest until the baby gets rid of     the extra water. As a result, babies have to stay in the intensive care unit and on a     breathing machine for longer.      Peritoneal dialysis, also known as PD, involves placing a small catheter into the belly     cavity at the time of surgery. PD helps the kidney to get rid of extra body water. PD     involves putting small amounts of special fluid into the belly through the catheter. This     special fluid attracts water and is drained hourly. By allowing the belly cavity to drain,     this helps both the heart and the lungs. This allows the chest to be closed and the breathing     tube to be removed. The investigators are looking to see how quickly the babies, with and     without PD, get rid of the extra water in turn shortening their stay in the intensive care     unit and in the hospital. PD is not permanent, and only used for the first few days after the     operation.   "
158027|NCT01215227|"     The primary purpose of this extension study is to assess the long-term safety and     tolerability of preladenant in participants from parent studies NCT01155466 [P04938] and     NCT01227265 [P07037] with moderate to severe Parkinson's Disease (PD). The study will also     characterize the long-term efficacy of preladenant in participants with PD.      Participants will continue to receive their stable regimen of levodopa (L-dopa) plus any     adjunct medications during the study as prescribed by their physician. Several classes of     adjunct medications may be used, including Amantadine, anticholinergics, dopa decarboxylase     inhibitors, and dopamine agonists.   "
158028|NCT01215214|"     Identification and evaluation of endogenous markers for the assessment of CYP3A activity     using metabolomics.   "
158029|NCT01215201|"     This study tries to determine whether the additional use of laser with cleaning (known as     scaling and root planning) will result in the reduction of inflammation, reduction of     bleeding upon examination and reduction of pocket depth in patients who are being maintained     on a regular basis but have pocket depths that are ≥5mm with bleeding. When a pocket is     bleeding, it is inflamed. It is usually cleaned with periodontal instruments (root-planed)     to establish health. Some research also advocates using laser therapy to treat a bleeding     pocket. Laser therapy is presently being performed in some dental offices and dental     colleges. This research is trying to see if the additional laser therapy is beneficial.   "
158030|NCT01215188|"     This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of     the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13™ based on immune     responses to the 13 serotypes in common Prevnar 13™   "
158031|NCT01215175|"     This study is being conducted to evaluate the safety, tolerability, and immunogenicity of     15-valent Pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and     toddlers.   "
158032|NCT01215162|"     The study is being done to determine the tolerance to single fraction intra-operative     electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy     for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost     irradiation that is usually given after EBRT. Data from two centers as well as preliminary     data from a randomized trial in Europe suggest that IOERT boost is well tolerated and     efficacious. In our study, patients will undergo standard lumpectomy and sentinel lymph node     sampling or axillary dissection. After the lumpectomy, IOERT of 10 Gy will be delivered in a     single fraction to the tumor bed by a mobile electron machine in the operating room. EBRT to     the whole breast will be administered once the surgical wound has healed adequately. The     primary objective is to determine the feasibility and acute patient tolerance to IOERT and     EBRT after lumpectomy. Secondary objectives include assessment of local control and distant     control of disease, as well as evaluation of long-term side effects and cosmetic outcome of     the treatment.   "
158033|NCT01215149|"     The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and     Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and     homologous prime-boost regimens at different time intervals.   "
158034|NCT01215136|"     The purpose of this trial is to explore the activity and safety of everolimus +/- paclitaxel     as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma.   "
158042|NCT01215032|"     Metformin is a medication that is prescribed for people with diabetes to help the body     respond better to its own insulin and decrease sugar production by the liver. This helps     control the body's blood sugar level and is approved by the Food and Drug Administration     (FDA) for the treatment of diabetes. Participant's in this research study will already be     receiving androgen deprivation therapy (ADT) for prostate cancer. ADT is considered standard     of care for prostate cancer. Changes in the participant's metabolism, including changes in     insulin and blood sugar levels, are often seen as a result of this type of hormone therapy.     Some studies have shown a relationship between insulin and prostate cancer. These studies     have suggested that insulin may signal tumor cells to grow. Other studies suggest that people     receiving metformin treatment for diabetes may enjoy better outcomes from their prostate     cancer then other similar patients who are not treated with metformin.   "
158043|NCT01215019|"     Osmotic therapy is a mainstay in the treatment of intracranial hypertension after traumatic     brain injury.This study proposes to compare two hypertonic saline agents in patients with     traumatic brain injury.   "
158044|NCT01214993|"     The current study is designed to confirm the mechanism behind the increase in serum     creatinine observed during GSK1349572 therapy; specifically, the study will determine whether     GSK1349572 has any effect on glomerular filtration rate (GFR) or effective renal plasma flow.     Absent such effects, one may conclude that the small increases in serum creatinine observed     are due to the inhibition of the tubular secretion of creatinine via organic cation     transporter 2 (OCT2) consistent with in vitro data. .   "
158056|NCT01214837|"     The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant     vaccination schedule including kinetics of immune response in the early phases of the series.   "
158057|NCT01214824|"     To demonstrate that in patients with persistent poorly controlled diabetes,     short/intermittent use of continuous glucose monitoring can driver better longer-term     glycaemic control and HbA1c.   "
158045|NCT01214980|"     Subjects requiring skin grafting due to burns, trauma, or chronic venous ulcers with split     thickness donor sites expected to be between 20 and 200 square cm will be consecutively     screened for study eligibility. This study is a prospective, randomized, controlled trial     evaluating effect of MIST Therapy on the healing of split thickness skin graft donor sites     compared to standard care. Subjects meeting all eligibility criteria and providing     appropriate written informed consent will be enrolled for study participation.   "
158046|NCT01214967|"     Premature infants are born at substantial risk for poor health and developmental outcomes,     which commonly include hearing and vision problems, developmental delays, and poor school     performance. Premature infants of low-income families face additional social risks known to     worsen these outcomes. The Institute of Medicine recognized this important public health     problem in its 2006 report, Preterm Birth, which argued for the need to improve the quality     of follow-up care for preterm infants discharged from the neonatal intensive care unit     (NICU). The underpinning of this proposal is that maternal depression - common among families     of premature infants - interferes with adherence to follow-up services, and (both through     this mechanism and directly) adversely impacts child health and development. Conversely,     alleviating depressive symptoms among these women represents a promising strategy to improve     adherence to NICU follow-up services and to improve the outcomes of this vulnerable     population.      This project aims to mitigate the adverse effects of maternal depression in this specific     high-risk population by testing a theory-based, parent-directed empowerment strategy, called     Problem Solving Education (PSE). In the past, similar strategies have been proven effective     for improving the mood and functioning of depressed adults, and for improving adherence to     medical treatment. However, they have never been tested in the setting of a parent-child     relationship or among families of premature infants.      This project involves a clinical trial of PSE among 50 low-income mothers at risk for     depression, who have premature infants in two Boston NICUs: Boston Medical Center and Tufts     Medical Center. The investigators aim to determine the impact of PSE on maternal depressive     symptoms and functioning, and adherence to child health supervision and immunization     schedules, vision screening, and early intervention evaluation for babies with suspected     developmental delays.      Approximately 100,000 children are born prematurely to low-income families each year.     Parent-directed PSE aims to improve outcomes for these children through the prevention and/or     attenuation of maternal depressive symptoms, as well as through family activation and     promotion of adherence to follow-up care. If successful, PSE could also provide the     cornerstone of a more generalizable empowerment strategy for families of children with     chronic medical conditions.   "
158047|NCT01214954|"     The purpose of this study is to determine whether supervised progressive resistance training     is effective in the early phase after Total Hip Replacement. The investigators hypothesise     that 10 weeks of supervised, progressive resistance training immediately after discharge will     lead to increased functional performance, muscle strength and muscle power compared to     standard rehabilitation consisting of home-based exercise.   "
158048|NCT01214941|"     Tramadol is an opioid analgesic, which is widely used in the treatment of acute and     neuropathic pain. After oral administration, tramadol is rapidly and almost completely     absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed     by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation     is catalysed by CYP2D6. The formation of inactive metabolites is catalysed by CYP3A4 and 2B6.     This study is aimed to investigate the possible interaction of oral tramadol with     itraconazole and ticlopidine, which are inhibitors of CYP3A4 and 2B6. Twelve healthy male or     female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of the     ideal weight for height are taken into the study. Primary endpoints of the study are plasma     concentrations of tramadol and its metabolites.   "
158049|NCT01214928|"     Vitamin D is a prohormone obtained through diet, supplementation, or sun exposure. Once     absorbed, this nutritional vitamin D undergoes a two-step reaction in the liver and in the     kidney to become the active hormone, calcitriol. Besides the kidney, many other body tissues     are capable of local vitamin D activation. This local tissue activity is important for     maintenance of health and relies on adequate levels of nutritional vitamin D. Not only are     dialysis patients deficient in calcitriol due to kidney failure, but they are also deficiency     in nutritional vitamin D. Low levels of vitamin D have been associated with higher rates of     death, heart and blood vessel disease, osteoporosis, falls, cancer, and autoimmune diseases.     Despite this, there is a lack of randomized controlled trials (RCT) examining the effects of     nutritional vitamin D in hemodialysis (HD) patients. The investigators hypothesize that     long-term supplementation with nutritional vitamin D in HD patients improves survival and     cardiovascular outcomes. Before embarking on a large scale RCT, the investigators propose a     small pilot RCT with 20 hemodialysis patients to: i) To determine the effects of     cholecalciferol (vitamin D3) in raising blood vitamin D levels; ii) To determine the     feasibility and barriers to successful randomization and adherence to treatment protocols,     which will inform subsequent studies.   "
158050|NCT01214915|"     The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide     Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's     previously treatment has either not been effective or has caused unacceptable adverse     reactions. The study will aim to show that platelet counts can be safely reduced in treated     patients to below 600 x 10^9/L after a minimum of three months treatment. To demonstrate an     positive effect platelet levels will need to remain below 600 x 10^9/L for at least 4 weeks.   "
158051|NCT01214902|"     The research objectives are to test the efficacy of a Modified CIMT treatment in babies     diagnosed with hemiplegia, treated in a home program, as compared to a control group of     babies receiving a parallel home program but with no CIMT.   "
158052|NCT01214889|"     This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine     versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea.      Primary Objective:      To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus,     Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to     acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's     TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the     three-dose primary vaccination.   "
158053|NCT01214876|"     A longitudinal study on immune responses in relation to protection against clinical malaria     episodes will be conducted in Apac District, Uganda. Three cohorts will be recruited:     children 1 to 5 years of age (n=250), children 6 to 10 years of age (n=125) and adults 25 and     above (n=125). After finger prick sampling (~300µL) and examination at enrolment,     participants will be followed up for one year. Follow-up will include fortnightly active case     detection and three-monthly cross-sectional surveys. Clinical malaria attacks and the     associated clinical and parasitological parameters will be related to immunological profiles     determined utilizing a protein microarray as a capture substratum to profile the humoral     immune response against a vast number of parasite antigens.      For individuals who experience a clinical malaria attack or who are diagnosed with high     density parasitaemia (≥15,000 parasites/µL) during cross-sectional surveys, a 5mL blood     sample is obtained to determine the diversity of parasite antigens in the population in     relation to antigen recognition in the cohort.   "
158060|NCT01213810|"     The goal is to demonstrate the immunogenicity and safety of Zostavax® in HIV positive     individuals. Study participants are stratified into different patient groups according to     their CD4 cell count, viral load and HIV Status.        -  Trial with medicinal product        -  Trial with immunomodulatory product / biological   "
158061|NCT01213797|"     With 11.000 deaths and 150.000 attempts each year in France, the suicide represents an     important public health problem. For each death by suicide, one can count 6 direct bereaved     people and 20 people in more indirect connection with this mourning (Terra 2001). In term of     impact, there is thus 300.000 people (annually) touched by the deaths by suicide and     3.750.000 people (annually) touched by the suicide attempt of a close relative. It seems     indeed important to have Public Health data on this cascade repercussion of the suicide     attempt.      A suicide attempt propagates a suffering cascade on the various circles of the family and     close entourage, which can be measured in term of traumatic stress and medico-economic     impact.      Objective = To measure the medico-economic impact on the entourage, in the 3 months following     the suicide attempt and at 1 year.   "
158062|NCT01213784|"     The investigators wish to investigate wether a more strict diabetic control improves cardiac     function, muscle strength, exercise capacity and decreases symptoms.      The investigators hypothesis is that improving the glycemic control in suboptimized diabetics     with heart failure will improve cardiac performance, muscle strength, exercise capacity and     decrease symptoms.   "
158063|NCT01213771|"     Background Denmark has a record-high incidence of, and mortality rate for, ovarian cancer.     There are 600 new cases of ovarian cancer each year. In 2008 the state issued a guarantee of     early diagnosis and treatment of all cases of suspected cancer, and surgical treatment has     been centralised and standardised in fast track programmes. However, the investigators do not     know how women with ovarian cancer experience the period prior to surgery and how they can     optimally prepare for treatment and care.      Aim The two principal aims of the study are to describe health and coping in Danish women     surgically treated for ovarian cancer; and to examine to what extent it is possible, from     both a patient and professional perspective, to improve the health and everyday life of     patients with ovarian cancer.      Materials and methods The study is conducted within the scientific theoretical framework of     hermeneutics, involving the overall concepts of health promotion and rehabilitation. The     study will be carried out in 4 stages between September 2008 and September 2011. Stage 1: A     health-related characterisation of Danish women with ovarian cancer through a registration     process. Stage 2: Qualitative research interviews with patients, to gain knowledge about     spontaneous preoperative coping strategies and resources.      Stage 3: The preoperative preparation programme will be developed and clinically tested. The     effect of participation will be measured by self-assessed health and coping before and after     surgery. The study period runs from the time the decision is taken to operate until eight     weeks after discharge. The study takes place at the Department of Gynaecology at Aarhus     University Hospital, Skejby in Denmark, which is a regional centre of surgical treatment of     gynaecological cancer.      Results The study provides insight into the preoperative coping strategies and general health     of Danish women suffering from ovarian cancer. The development and testing of the     preoperative preparation programme contributes to knowledge about optimisation of     preoperative preparation. This might have a positive impact on the participants' general     health and level of functioning during their treatment. Furthermore, the project contributes     to knowledge of the preoperative coping strategies and experiences of (female) cancer     patients in general.   "
158064|NCT01213758|"     Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the     galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique     provides volumetric mapping of liver function and it allows quantisation of liver function.     The method may be used for selection of patients for stereotactic radiotherapy of liver     tumors, for determination of radiation induced liver dysfunction and may be included into the     treatment planning process of stereotactic radiotherapy.   "
158065|NCT01213745|"     This study will investigate the effectiveness of using the European Organisation for Research     and Treatment of cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13) to     identify and target therapies in patients with lung cancer. The study will assess whether     using the questionnaire will result in an improvement in QoL.   "
158066|NCT01213732|"     In this study the recombinant human fusion protein L19TNFα will be associated in ILP with the     standard treatment with melphalan 10mg/l limb volume in subjects affected by stage III/IV     limb melanoma.      The recombinant human fusion protein L19TNFα was created with the intention to target TNFα     directly to tumor tissues with the result in high and sustained intralesional bioactive TNFα     concentrations.   "
158067|NCT01213719|"     It has been suggested that betaine supplementation may improve muscle strength by increasing     muscle creatine content. However, there is no data supporting this assumption. The     investigators speculate that betaine supplementation could enhance intramuscular creatine     content, which would result in strength improvements.   "
158068|NCT01213706|"     In the present proposal the investigators wish to assess the effect of a single session with     the device known as Exer-Rest® which applies Whole Body Periodic Acceleration (WBPA) on     baseline airway blood flow (Qaw) and in Qaw variation, in current smokers,     glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers, with the expectation     that the treatment will transiently increase the Qaw, and to a greater extent in the current     smokers and patients with asthma who have endothelial dysfunction.   "
158069|NCT01213693|"     Exacerbations are important events in the natural history of chronic obstructive pulmonary     disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that     exacerbations negatively affect the natural history of the disease; e.g. lung function     decline is accelerated in patients with frequent exacerbations. Bacteria are considered the     most relevant cause of exacerbations, but there is evidence that viral infections are equally     contributing.      Either alone or in combination with viruses, airway bacterial load in stable COPD correlates     with both the frequency of exacerbations and the decline in lung function.      A long-term clinical trial recently showed that the regular treatment with inhaled     corticosteroids (ICS) increases the risk of infectious events such as pneumonia, whereas it     reduces the frequency of acute COPD exacerbations in COPD.      In a recent study it was found that airway bacterial load increases over time (1 yr follow     up) in stable COPD. In this study, virtually all patients (93%) were treated with ICS.      This study is designed to evaluate whether long-term (1 year) ICS treatment increases viral     and/or bacterial load in the sputum of COPD patients.   "
158070|NCT01213680|"     The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg     and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease   "
158071|NCT01213667|"     To assess genetic features and intraocular cytokine profiles of non-responders to anti-VEGF     treatment of exudative age-related macular degeneration. Also to assess necessity and     frequency of pro re nate medical re-treatment.   "
158072|NCT01213654|"     A pilot study to observe satisfaction of analgesia with intercostal catheters after VATS     lobectomy.   "
158074|NCT01213628|"     Eighty adult patients undergoing open colon surgery will be randomized to either:standard     warming measures or to additional insufflation of humidified carbon dioxide in the open wound     cavity during major abdominal surgery.      PRIMARY AIM is to test if core and local temperature can be increased.   "
158075|NCT01213615|"     Since the first implant in September 1982, the Medtronic Hancock® II has provided more than     20 years of excellent hemodynamic performance and durability. Design improvements over the     past generations include: low profile, flexible stent, Supra-X™ supra-annular placement, T6     anti-calcification tissue treatment, modified fixation process, CINCH® advanced implant     system and ULTRA™ minimized sewing ring. Valve sizing is a critical consideration in     obtaining optimal hemodynamic performance. This is particular true in small aortic roots. A     critical issue is the size of the prosthesis in relation to the patient's annulus.      The objective of this clinical study is to evaluate, at six and twelve months, the     hemodynamic performance of the HancockÒ Ultra™ bioprosthesis in the aortic position, to     analyze the incidence of patient prosthesis mismatch, correlation of gradients, and to     ascertain frequency at which a larger valve size is used vs. a patient's debrided annulus     diameter.   "
158076|NCT01213602|"     The principal objective is to notice the relevance of timing performance of femoral block for     knee replacement surgery during general anesthesia and analyze the relationship with     bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia.     Otherwise the investigators try to investigate if the timing of performance of this block     influence in postoperative variables as pain or blood loss.   "
158077|NCT01213589|"     The purpose of this post-market release registry is to collect additional information     concerning safety, performance and health economic data with respect to the Medtronic VALIANT     Thoracic Stent Graft with the Xcelerant Delivery System in the treatment of descending     thoracic aortic dissections.   "
158078|NCT01213576|"     Albendazole and ivermectin are currently used in combination for annual mass treatment of     lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such     programmes is very high and has proven to be a major impediment to the success of programmes     in many countries with limited financial resources.      Data from albendazole treatment of other filarial infections and one study comparing single     to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased     dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae.     It is essential to determine whether such higher doses are indeed beneficial since this could     have far-reaching effects on the conduct and management of the main mass treatment programmes     and also in the management of programmes as they near elimination.   "
158079|NCT01213563|"     Gastric bypass surgery has been proposed as an effective treatment strategy for type 2     diabetes mellitus (T2DM), but thus far algorithms for the management of T2DM immediately     after surgery have not been established. The investigators designed an algorithm to achieve     good glycaemic control in patients with insulin-requiring T2DM upon discharge after gastric     bypass surgery, and evaluated this algorithm for feasibility, efficacy, and safety.   "
158080|NCT01213550|"     The aim of this study is to evaluate the therapeutic effectiveness of chlorhexidine     mouthrinse on gingival inflammation and subgingival microbiota in addition to daily     mechanical plaque control in a population with established gingivitis.   "
158082|NCT01214785|"     The study is a cluster-randomized, controlled trial conducted among 100 villages (including     approximately 3500 households and 20,000 people) in Puri district, State of Orissa, India.     The study aims to assess the impact of the construction and use of latrines in rural settings     on diarrhoeal disease, helminth infections and nutritional status. The study will also report     on the cost and cost-effectiveness of the intervention and its impact on lost days at school     and work as well as on expenditures on drugs and medical treatment. The study will document     how the intervention actually impacts exposure to human excreta along principal transmission     pathways by evaluating the impact on (i) faecal contamination of drinking water, (ii) the     presence of mechanical vectors (flies) in food preparation areas, and (iii) the presence of     faeces in and around participating households and villages. The study will also explore the     extent to which different levels of acquisition and use of on-site sanitation among     householders impact disease throughout the community.   "
158083|NCT01214772|"     Embryo transfer failure is defined as ≥3 IVF-embryo transfer failures without pregnancy . In     spite of transfer of 3 good quality embryos , just 20-30% of women undergoing IVF will     achieve ongoing pregnancy . There are multiple factors that influence IVF-failure.      Autoantibodies may be one of the possible causes of IVF-failure , especially in unexplained     and mechanical infertility .      In some studies , antiphospholipid antibody is considered as causative factor on implantation     and embryo failure. However some investigators showed that combination therapy with     heparin/aspirin in women with positive antiphospholipid antibody is not effective in     improving of IVF-outcome . In prospective studies were not confirmed association between     antiphospholipid antibody abnormalities and IVF-failure.      Recently has been relationship between thrombophilia and IVF and implantation failure.      The effect of unfractionated heparin in assisted reproductive technology (ART) cycles is     prevention of thrombosis in implantation site . Although its effect is not restricted to     anticoagulation and also can modulate apposition , adhesion , and penetration of embryo .     Other advantages are decreasing thrombophilic risk in COH ( controlled ovarian     hyperstimulation) cycles with administration of gonadotrophins . So heparin make better     pregnancy rate in repeated IVF-ET failures.      There are few studies in regard to heparin effects on IVF cycles outcome . The purpose of     this study is evaluation of unfractionated heparin effects on improvement of ART outcome .      This study was a prospective randomized controlled trial to assess whether administration of     heparin would increased pregnancy rates in women with repeated ET-IVF failures.   "
158084|NCT01214759|"     This study will evaluate the safety and tolerability of the combination of truvada and     raltegravir given for 28 days for the prevention of HIV infection.   "
158085|NCT01214746|"     It has been documented that statin reduce mortality and morbidity in patients with     cardiovascular disease. This effect can partly be related to a reduction in cholesterol     levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as     nephropathy, diabetes and hypertension. The purpose of this study is to investigate the     effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular     variables in healthy man.   "
158086|NCT01214733|"     This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra     (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients     with moderate to severe rheumatoid arthritis. Patients who successfully completed studies     WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will     be allowed DMARDs according to the treatment they received in the previous studies. Patients     will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on     study treatment is 104 weeks.   "
158087|NCT01214720|"     This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to     a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated     time of study treatment is until confirmed evidence of disease progression, and the target     sample size is 500+ individuals.   "
158088|NCT01214707|"     Characterization of the cardiac response (ECG) preceding an epileptic seizure.   "
158089|NCT01214694|"     The purpose of this study is to test two on-line interventions for families of young children     who have experienced moderate or severe traumatic brain injury (TBI). This project builds     upon the investigators' previous research by modifying the online intervention content to     address the needs of young children with TBI. The goal of this project is to develop an     intervention that will encourage positive parenting behaviors, improve child behaviors, and     reduce parent distress and burden following TBI. The investigators hypothesize that the     intervention groups will exhibit more effective parenting skills as well as better child     functioning and lower levels of parental distress at follow-up than will the active     comparison group.   "
158090|NCT01214681|"     Colorectal cancer is a common disease worldwide. It is now thought that colorectal cancer     cells arise from stem cells where the genetic material regulating growth and division of the     stem cell has become defective. This leads to unregulated production of cells which in turn     have defective genetic information and cancer formation.      Research into colorectal cancer is hampered by the fact that studies must take a very long     time to produce results and be very large if the development of a cancer is the endpoint.     Therefore alternative methods of quantifying the risk of developing a cancer are required so     trials can be a realistic size and be completed in a realistic time frame. The investigators     have previously identified several candidates for these 'biomarkers'. The next stage in     proving or disproving these as useful biomarkers is to test their response to a dietary agent     that the investigators know reduces the risk of colon cancer.   "
158091|NCT01214668|"     The goal of this study is to determine the dose of LY573636 that can be administered safely     in combination with liposomal doxorubicin in patients with advanced cancer who have failed a     prior treatment.      The study consists of a dose escalation phase to the maximum tolerated dose (MTD)and a dose     confirmation phase in patients with platinum resistant epithelial ovarian, fallopian tube or     primary peritoneal cancer who have never been treated with doxorubicin.   "
158092|NCT01214655|"     This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient     dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355     that can be safely administered to patients with acute leukemia. Part A and Part B are dose     escalation of two schedules in patients with acute leukemia. Parts A and B will enroll     concurrently. Part C is a dose expansion for each schedule in patients with acute     myeloblastic leukemia (AML).   "
158095|NCT01214616|"     -  To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine          i.v. by assessment of Dose Limiting Toxicities (DLT);        -  To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics          of afatinib and vinorelbine i.v.   "
158096|NCT01214603|"     Study JWYB is a multicenter, non-randomized, open-label, Phase 2 study of intravenous     LY2090314 in participants with acute leukemia.   "
158097|NCT01214590|"     The purpose of this study is to assess the safety and the preliminary efficacy of treatment     by the VascuActive device on peripheral diabetic neuropathy, and to correlate this effect     with physiologic changes.      Patients will undergo a 4-week period of home treatment by the VascuActive device, and will     be monitored during this period and during a two-month follow-up period for the efficacy of     the device in reducing neuropathic pain, sensation impairment and other signs and symptoms.   "
158098|NCT01214577|"     This study is primarily designed to evaluate the safety and tolerability of PEP005 Gel,     0.015% when administered for up to three consecutive days to photo-damaged skin on the face.     The secondary endpoint is to determine the efficacy of PEP005 Gel, 0.015% when administered     for up to three consecutive days in patients with photo-damaged skin on the face.   "
158099|NCT01214564|"     This study is primarily designed to investigate whether treatment, once daily for up to three     consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in     patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to     investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive     days to Seborrhoeic Keratosis on non-head locations.   "
158100|NCT01214551|"     The purpose of this study is to increase the knowledge of the possible diagnostic effect of     exercise induced bronchoconstriction performing a repeated exercise challenge test.   "
158101|NCT01214538|"     This clinical study is designed to assess prospectively the sero-responses to various     proteins in cases of pneumococcal Acute Otitis Media.   "
158102|NCT01214525|"     The improvement in uroflow and postvoid residual urine in children after urethral meatotomy     for meatal stenosis. The hypothesis is that there is an improvement in both parameters, thus     justifying the procedure.   "
158103|NCT01214512|"     This study is aimed to evaluate the performance of the Micromedic CD24 assay in identifying     colorectal adenoma using Western blot and ELISA assays. These assays are designed to detect     CD24 protein in peripheral blood leukocytes (PBL). Elevated levels of CD24 may be indicative     of colorectal adenoma (inclusive of optically detectable early adenoma to late adenoma, and     cancer).   "
158118|NCT01214317|"     The purpose of this study is to compare the effect of combinative induction therapy with     mitoxantrone and plasmapheresis versus induction therapy with mitoxantrone alone in cases of     aggressive multiple sclerosis   "
158119|NCT01214304|"     The purpose of this study is to determine whether aromatherapy with lavender oil compared to     placebo lowers anxiety levels in women during colposcopy.   "
158104|NCT01214499|"     Coronary disease is one of the most frequent pathology of the modern world and the leading     cause of death in the investigators country. In Spain more than 50.000 coronary percutaneous     intervention and more than 5.000 coronary artery bypass graft (CABG) procedures are performed     every year. Despite this data about 12% of patients have diffuse coronary disease and are not     candidates to conventional therapies. Also between 15-25% of patients undergoing coronary     bypass grafting receive an incomplete revascularization due to the poor quality of the     coronary vessels.      Transmyocardial revascularization (TMR) is a surgical procedure that uses a laser to create     channels through the myocardial, so this laser stimulates local angiogenesis and provides     blood in the ischemic area. Results of this procedure have shown clear benefits in terms of     reduction of angina and increase of survival of patients, compared to medical treatment.      Cell therapy in heart disease is offering in recent years encouraging results despite the     methodological difficulties that being able to use this technique sometimes involves. The     basis lies in the potential ability of stem cells to differentiate into any type of adult     cell. In the case of cardiac cell therapy, stem cells can differentiate into myocardial cells     or vascular cells capable of developing angiogenesis. Further studies are needed to draw firm     conclusions about the clinical impact that the use of stem cells has on cardiovascular     disease.      Recently a system has been developed to create, at the same time and in a simple and     effective way, the laser channels and the introduction of stem cells on the edges of these     channels. This system called PHOENIX ™ consists of a laser probe capable of creating     transmural channels in the myocardium.      Based on the what has just been explained, it is quite possible that the combination of both     therapies can increase successful results regarding the reduction in angina these patients     need. Initially, and after having some experience with this type of treatment, the results     could be analyzed and compared with the results obtained through laser therapy, with the help     of a controlled clinical trial, such as the one the investigators are proposing.   "
158105|NCT01214486|"     The primary purpose of this study is to analyze and compare plasma and intracellular     concentrations of Raltegravir (RAL) in blood plasma and in peripheral blood mononuclear     cells, using high performance liquid chromatography (HPLC).   "
158106|NCT01214473|"     Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and     mortality in the newborn period around the world. India, with one of the world's largest     populations, continues to struggle with extremely high infant and neonatal mortality rates.     Sepsis accounts for 50% of deaths among community born (and 20% of mortality among     hospital-born) infants. Closely linked with this is a burgeoning problem of antimicrobial     resistance, which is increasingly restricting the therapeutic options for medical care     providers. Friendly bacteria called Probiotics have been used in multiple infectious and     inflammatory disease states in humans. Fructooligosaccharides are sugars found naturally in     many fruits and vegetables and also in human breast milk. These sugars reach the colon     undigested and serve as food for the friendly bacteria. The current study uses a probiotic     preparation containing Lactobacillus plantarum and fructooligosaccharides as an attempt to     prevent neonatal infections. Currently no conclusive data are available on the utility of     probiotics in such conditions. If successful, such inexpensive preventive therapy can be made     available to general public in resource poor countries. Similar preparations can also be used     in the western world to prevent similar infectious conditions of the neonatal period,     especially in preterm infants where sepsis continues to be a major cause of hospital stay and     death.   "
158107|NCT01214460|"     Patients in general wards have abnormal physical values preceding in-hospital cardiac arrest     or a transfer to intensive care unit (ICU). The purpose of Medical Emergency Team (MET) or     EMS is to interfere early enough in deteriorating patient status to prevent adverse outcomes     like cardiac arrest or transfer to intensive care unit. The aims of this study are to record     and analyze the effects of EMS and department of emergency and both afferent and efferent     limbs of MET activity in Finnish tertiary Hospital.   "
158108|NCT01214447|"     This prospective observational study is planned to validate OSND against the prospective     morbidity and mortality in chronic hemodialysis patients and to examine the hypothesis that     OSND risk stratification of chronic HD patients is useful in predicting outcomes and better     than its component alone or in diverse combinations. The investigators specific aim is to     validate OSND in chronic HD patients by comparing it with conventional measures of     nutritional state, including blood tests, anthropometry, MIS, GNRI, bioelectric impedance     analysis and several measures of clinical outcome including prospective mortality and     hospitalization.   "
158111|NCT01214408|"     This prospective, open label, single-center and non-comparative study is designed to generate     data on Digene Total's (buffered pantoprazole) rapid and sustained gastric acid inhibition     effect in patients suffering from acid peptic disorders.   "
158112|NCT01214395|"     This study will compare the use of tea tree oil as a topical nasal antiseptic to prevent     infections in patients that need renal dialysis. A maximum of fifty subjects will be     recruited and will be assessed for signs of infection once per week for the first 6 weeks and     then every 4 weeks until week 26. They will also be checked for nasal carriage of 'Golden     Staph' when they enroll in the trial. The subjects will complete the trial if they have 26     weeks infection-free or if they have an infection during that period   "
158113|NCT01214382|"     This study is being conducted to evaluate how the body absorbs and processes the medication     sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric     bypass surgery. Participants will be asked to take part in this study at three time points:     1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve     months following surgery. This study will enroll approximately 30 participants.   "
158114|NCT01214369|"     -  Hypothesis:             -  X-tip intraosseous is an effective supplementary injection in mandibular hot teeth               as well as Periodontal Ligament (PDL) injection        -  Purposes:             -  Comparing the anesthetic efficacy of X-tip intraosseous and PDL injection in               mandibular hot teeth which had not been anesthetized after 3.6 ml Infra Alveolar               Nerve Block        -  Methods and Materials:             -  forty patients with mandibular hot molar or second premolar which had not been               anesthetized after 3.6 ml inferior alveolar nerve block injection will be selected               for this study   "
158115|NCT01214356|"     This purpose of this project is to evaluate the effectiveness of vitamin D supplementation     over 12 months in vitamin D deficient African American adults with type 2 diabetes.   "
158116|NCT01214343|"     The purpose of this study is to evaluate the efficacy of sorafenib in combination with low     dose cisplatin /fluorouracil hepatic arterial infusion chemotherapy in patients with advanced     hepatocellular carcinoma.   "
158117|NCT01214330|"     The purpose of this study is to see if it is possible to conduct a full study to determine     whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed     Pap test in detecting precancerous cervical lesions in females.      Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.   "
158122|NCT01214265|"     To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior     tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented     overactive bladder.   "
158123|NCT01214252|"     To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in     the treatment of abdominal wall defects.   "
158124|NCT01214239|"     In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of     Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of     treatment in monotherapy in patients with type 2 diabetes and insufficient glycaemic control.   "
158125|NCT01214226|"     The treatment of severe forms of alcoholic hepatitis (AH) constitutes a major challenge for     clinicians involved in the management of severe alcoholic liver disease. In patients with     Maddrey function higher than 32, compelling evidence from data has shown that corticosteroids     improve short-term survival. However, novel strategies or molecules are required in light of     the fact that approximately 40 % of patients continue to die at 6 months. A double-blinded     randomized controlled trial of 101 patients has showed that Pentoxifylline improves survival     of patients with severe AH, as compared to placebo. In terms of mechanisms, the effect of     pentoxifylline is related to prevention of hepatorenal function whereas corticosteroids     induce an early improvement in liver function. When considering these differences of     mechanisms, many clinicians suggest that the addition of pentoxyfilline to corticosteroids is     an attractive option that needs to be tested in patients with severe AH.   "
158126|NCT01214213|"     There is evidence for altered muscle activity patterns in individuals with non-specific     chronic back pain (NSCBP). It is unknown why these alterations in activation pattern occur     and how they may be linked to pain experience and to the development of CNSBP. The main     objective of this study is to investigate the spatial aspects of muscle activation in     relation to fatigue/endurance and CNSBP. A novel approach, utilizing a new multi-channel     surface-EMG (MCsEMG) technique will be applied in this project to get insight in fundamental     mechanisms related to motor control and fatigue/endurance. In this project data from healthy     persons and from patients with NSCBP will be collected and analyzed. NSCBP patients will be     compared to healthy persons. To minimize heterogeneity between groups the subject's age range     will be from 30 - 50 years. The investigators main hypothesis is that motor control     mechanisms of the lumbar muscles are disturbed in NSCBP patients compared to normals,     explaining the reduced tolerance for static postures. There has been little investigation of     the lumbar musculature with MCsEMG recordings. The lumbar musculature has a complex     organization; many, relatively small muscles, in a restricted area. Utilizing two HDsEMG     grids with 252 Ag/AgCl contacts will be the superior non-invasive method to investigate motor     control mechanisms in this region, and further the investigators understanding of     neuromuscular adaptations related to NSCBP. The project may demonstrate changes that will     lead us to new insight and new strategies for the treatment of back pain.   "
158921|NCT01203527|"     The purpose of this study is to determine the pharmacokinetics (PK) of the anti-flu     medication, Tamiflu during pregnancy and to determine to what extent pregnancy may affect the     currently recommended dosage of this medication.   "
158127|NCT01214200|"     The purpose of this pilot study is to evaluate the effect of high intensity non-invasive     positive pressure ventilation (HINPPV) for stable, hypercapnic COPD patients. The     investigators believe that HINPPV, used at least 6 hours nocturnally over three months, will     benefit the stable hypercapnic COPD patient through a reduction in the daytime partial     pressure of carbon dioxide in arterial blood (PaCO2) levels.   "
158128|NCT01214187|"     The purpose of this study is to determine whether low concentration inhaled carbon monoxide     is effective in treating idiopathic pulmonary fibrosis.   "
158129|NCT01214174|"     This study will test the efficacy and safety of IBI-10090 in the treatment of ocular     inflammation after cataract surgery.   "
158130|NCT01214161|"     The intrauterine device (IUD) is a form of birth control that is extremely effective and     safe, even in women who have not yet had children. Women can experience high levels of pain     when the IUD is placed inside the uterus, and fear of this pain could be a reason that women     decide not to use this method.      This study will randomly (like flipping a coin) assign women who have chosen the IUD as their     contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their     cervix prior to having the IUD inserted; the other will have an inert gel placed into their     cervix instead. The level of pain at three different time points on a 10cm scale and the     patient's satisfaction with the procedure will be compared between the two groups to see if     using lidocaine gel helps decrease IUD insertional pain   "
158131|NCT01214148|"     A prospective, single-treatment, multi centre clinical trial enrolling 30 patients in 2     centres in Romania, with a clinical and angiographic follow-up at 4 and 9 months to determine     the primary endpoint of late lumen loss and secondary endpoints. A subgroup of 15 patients     will also undergo post implantation, 4 and 9 months IVUS examinations. Additional clinical     follow-ups take place at 1 month and yearly up to three (3) years.      The objective of this trial is to assess the safety and clinical performance of the ORSIRO     drug eluting stent in patients with single de-novo coronary artery lesions.   "
158132|NCT01214135|"     The primary objective of this non-interventional study is to investigate how Seroquel XR and     Seroquel IR are used in the clinical practice of inpatients with schizophrenia. This will be     done by a retrospective review of medical records to evaluate patients treated with Seroquel     XR or Seroquel IR as primary antipsychotic treatment.   "
158133|NCT01214122|"     The primary purpose of this study is to determine whether the treatment with AZD9668 will     affect the metabolism and effect of Warfarin.   "
158134|NCT01214109|"     To establish bioequivalence at steady state of:      1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg     pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended     release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet     t.i.d. in fasted status      To investigate dose proportionality of pharmacokinetics parameters for:      1)pramipexole extended release dosage of 0.375 to 1.5 mg q.d.   "
158135|NCT01214096|"     Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous     Administration in Patients With Chronic Systolic Heart Failure   "
158136|NCT01214083|"     The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine +     high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in     reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than     low-dose naltrexone (50 mg) alone in reducing alcohol drinking.   "
158137|NCT01214070|"     The objective of this study is to test functional vision outcome measures that reflect the     loss in everyday life tasks that require vision and that are sensitive to changes after a     course of vision rehabilitation in Veterans/participants with TBI.   "
158138|NCT01214057|"     The purpose of this study is to compare total intravenous anesthesia to inhaled anesthesia in     endoscopic sinus surgery for chronic sinusitis. The investigators will compare bleeding     during surgery, duration of surgery, blood flow to the nose and other parameters. The     investigators hypothesize that total intravenous anesthesia decreases bleeding and improves     the view during surgery.   "
158139|NCT01214044|"     The goal of the study is to obtain preliminary data that will test whether the antidepressant     medication escitalopram resets the body clock: a collection of nerve cells in the brain that     control the timing of many body processes. The study will also test whether the improvement     in depression symptoms with escitalopram correlates with the degree to which the timing of     the body clock is properly aligned with the timing of sleep.   "
158140|NCT01214031|"     Chromoendoscopy (that involves spraying of dyes over the colonic mucosa) combined with     magnification has been utilized for polyp histology identification. Pit patterns on the     surface of polyps described by Kudo et al have been shown to have a high diagnostic accuracy     in differentiating the polyp types (18, 19). NBI, that is also referred to as electronic     chromoendoscopy is another technique that has been evaluated for polyp histology     identification by highlighting the superficial mucosal and vascular architecture (15, 20,     21). pCLE is another novel addition to the technologies aiming to accomplish in vivo     histologic diagnosis with a high degree of accuracy. The pCLE system has three major     components (Mauna Kea Technologies, Paris, France). The first is the confocal miniprobe made     of approximately thirty thousand optical fibers bundled together and terminated by a distal     microsystem. The images obtained have a lateral resolution of 1µm, an axial resolution of 10     µm and a maximum field of view of 240 µm. The depth of observation is from 55 to 65 µm. The     miniprobe tip diameter is 2.5 mm and can be passed through the accessory channel of any     standard endoscope. The second is the laser scanning unit (excitation wavelength - 488 nm)     that combines the functions of laser light illumination and rapid laser scanning, enabling a     frame rate up to 12 images per second and signal detection. The third is the control and     acquisition software for real time image reconstruction, immediate sequences display and     post-procedure analysis and editing tools. Once an area of interest (e.g. a polyp) is     identified, 5 ml of 10% fluorescein sodium is injected intravenously; the confocal probe is     passed through the accessory channel of the endoscope and placed against the lesion to obtain     several high-quality images and video sequences. In a study by Buchner et al from the Mayo     Clinic, Jacksonville, (22) this system was used to evaluate confocal images of 37 polyps from     25 patients in a blinded fashion without the knowledge of their histologic diagnosis or     endoscopic appearance. The investigators developed the following criteria that were     suggestive of neoplastic polyps: villiform pattern, nuclear characteristics - oval/irregular     nuclear shape and increased number of nuclei. These features had a sensitivity of 82.6%,     specificity of 92.9% and accuracy of 86.5% for the characterization of neoplastic polyps.     Similarly, Meining et al (23) have also evaluated criteria for differentiating neoplastic     from benign lesions in the colon with encouraging results.      The investigators hypothesize that pCLE will have a high rate for accurate characterization     of polyp histology real time during colonoscopy   "
158141|NCT01214018|"     The goal is to compare post tramautic stress between the nearest relatives of brain-dead     patients who are organ donor to those of brain-dead patients who are not organ donors for     medical, legal or opposition reasons.   "
158142|NCT01214005|"     This project tests two hypotheses concerning the low smoking cessation rates in smokers with     schizophrenia. The first hypothesis is that smokers with schizophrenia experience stronger     and more sustained effects of smoking abstinence on negative mood and smoking urge than     control smokers without psychiatric illness. The second hypothesis is that smokers with     schizophrenia experience stronger reinforcing effects of a smoking lapse (i.e., more     rewarding effects of smoking after a period of abstinence) than control smokers without     psychiatric illness.   "
158143|NCT01213992|"     The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg     and 1000 mg) of Monofer® in patients suffering from Non-dialysis Dependent Chronic Kidney     Disease.   "
158144|NCT01213979|"     The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg     and 1000 mg) of Monofer(R)in patients suffering from non-hematological malignancies with     Chemotherapy induced anaemia.   "
158145|NCT01213966|"     A Phase IIa Exploratory, Open label, Single Dose Regimen, Multiple Dose Testing Clinical     Study to Assess the Preliminary Efficacy, Tolerability and Pharmacokinetics of OZ439 in adult     patients with acute, uncomplicated Plasmodium falciparum or vivax malaria mono-infection.   "
158146|NCT01213953|"     The study is designed for evaluating the presence of mesenchymal stem cells of vertebral     disc. Isolation and authentication of these cells may be applied for the vertebral disc     regeneration and the research tissue engineering.   "
158147|NCT01213940|"     Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies     and in the number of circulating functional replicative competent endothelial progenitor     cells (EPC's) after bariatric surgery.   "
158148|NCT01213927|"     Hepatocellular carcinoma (HCC) is a major public health problem, whose incidence is     increasing in developed countries and is the leading cause of death in patients with     cirrhosis. The diagnosis and the early management are key issues that could improve the     prognosis. In France, alcoholic cirrhosis is the leading cause of HCC, while the aetiology of     underlying chronic liver disease is mainly hepatitis C (HCV) in Southern Europe and Japan,     and hepatitis B (HBV) in Asia and Africa. In the next years, due to the improved results of     anti-viral therapies, this trend should be reinforced with a decreasing proportion of HCC     related to viral cirrhosis and an increasing proportion of HCC related to alcoholic     cirrhosis. However, natural history of alcoholic cirrhosis remains poorly understood, most     studies being retrospective and including a small number of patients. This project is filed     by the consortium CIRRAL including French Academic hospitals centers currently involved and     referees in the field of alcoholic liver disease and HCC (8 at the moment, and more in the     next months). It is a national multicenter prospective study that will include 1200 patients     with alcoholic cirrhosis histologically proven over 3 years. The main goal of this cohort is     to describe the natural history of a large number of patients with alcoholic cirrhosis     prospectively followed, and to identify predictors of the occurrence of HCC.   "
158149|NCT01213914|"     The purpose of this study is determine if High-Volume Hemofiltration in addition to     'contemporary' care will result in an improvement of select clinical outcomes when compared     to 'contemporary' care alone in the treatment of critically ill patients with ARF secondary     to septic shock.   "
158150|NCT01213901|"     To determine which anatomic site offers the most consistent (superior) absorption of insulin.      To determine the injection technique which allows the most consistent subcutaneous injection     of insulin (to pinch or to spread).      Hypothesis:      Based on age-related changes in the amount of subcutaneous fat we anticipate that the     absorption of insulin from various anatomical sites will differ.      Justification:      To date health care professionals have extrapolated data obtained from younger adults and     applied the results to the elderly.      Objectives:      To determine the rate of insulin absorption from different anatomic sites in diabetic     patients over the age of 70.      To determine the best practice for subcutaneous injection in older adults.      Research Method:      Measurement of serial glucose and insulin levels using 360 minute euglycemic clamp studies.      Statistical Analysis:      Paired t test, repeated measures ANOVA   "
158151|NCT01213888|"     To evaluate the effects of Trientine Hydrochloride in prevention of post-laser (pan-retinal     photocoagulation) macular edema in the eyes for subjects with diabetic retinopathy. Trientine     hydrochloride can limit secondary inflammatory damage to retinal vessels following the     administration of pan-retinal photocoagulation therapy for severe non-proliferative diabetic     retinopathy or retinal neovascularization due to diabetic retinopathy, resulting in less     macular edema and improved visual outcomes.   "
158152|NCT01213875|"     The home based intervention is a multidisciplinary approach that has shown benefit in the     follow-up of patients with Heart Failure (HF). It is considered one of the most effective     approaches and humanized by education and care for the patient in his environment of routine.     In this study the monitoring of HF patients in the home after hospital discharge will include     the reinforcement, monitoring and reassessment of previously provided guidance on the disease     and self-care, compliance to prescribed medications and especially the early recognition of     signs and symptoms of decompensation by patients and their caregivers.   "
158153|NCT01213862|"     Home visits (HV) are one of the multidisciplinary approaches that has already shown to     benefit the follow-up of Heart Failure (HF) patients. It is considered to be one of the most     effective and humane approaches as it educates and takes care of the patient in his/her     routine environment. In this study, the follow-up of HF patients in a home setting after     being discharged from hospital will include the reinforcement, monitoring and re-evaluation     of guidelines previously provided about the disease and self-care, compliance to prescribed     medicines and, specially, the early recognition of decompensation signs and symptoms by     patients and their caregivers.   "
158154|NCT01213849|"     The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF)     and equivalence of vilanterol (VI)following single dose administration of FF/VI via the novel     dry powder inhaler in healthy subjects.   "
158155|NCT01213836|"     This will be a phase IV 20 -32 day prospective, double blind, double-dummy, randomised     crossover study that will evaluate the effect of quetiapine XR and quetiapine IR on cognitive     performance in patients with schizophrenia stabilized on a single antipsychotic medication.   "
173751|NCT00108251|"     The primary purpose of this study is to determine whether eplerenone has a beneficial effect     on improving exercise ability in patients with diastolic heart failure.   "
158156|NCT01213537|"     This study aims to investigate the effect of a pacemaker device used in heart failure     patients which is called Cardiac Resynchronisation Therapy (CRT). Specifically the     investigators aim to investigate if the CRT pacemaker has an effect on breathing stability in     these patients and particularly breathing stability at night. Our theory is that the CRT     pacemaker may improve the stability of breathing in patients with heart failure.   "
158157|NCT01213524|"     The objective of this study is to investigate the relative contributions of nicotine     replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on     abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms,     cognitive task performance and smoking behavior in smokers with schizophrenia and     non-psychiatric smokers.   "
158158|NCT01213511|"     The aim of this study is to assess the effect of minimal (MECC) versus conventional (CECC)     extracorporeal circulation on neurocognitive function after elective coronary bypass grafting     (CABG) as well as whether this can be attributed to improved cerebral perfusion     intraoperatively.   "
158159|NCT01213498|"     It has been documented that statin reduce mortality and morbidity in patients with     cardiovascular disease. This effect can partly be related to a reduction in cholesterol     levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as     nephropathy, diabetes and hypertension. The purpose of this study is to investigate the     effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular     variables in patients witk chronic kidney disease.   "
158160|NCT01213485|"     This observational study will evaluate the course of treatment, the efficacy on anemia and     the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic     kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal     dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating     agents (ESA). Data will be collected from each patient for 12 months.   "
158161|NCT01213472|"     The purpose of this study is to investigate the safety, immunogenicity and clinical activity     of GSK2241658A antigen-specific cancer immunotherapeutic (ASCI) for the treatment of patients     with non-operable and progressing metastatic cutaneous melanoma.   "
158162|NCT01213459|"     This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the     HPV type distribution among women >= 15 years of age, attending routine gynaecological     examination in the Kingdom of Saudi Arabia.   "
158163|NCT01213446|"     This is an open-label study to investigate the pharmacokinetics (PK), efficacy, and safety of     a von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, in children with Von Willebrand     disease (VWD) in whom treatment with a VWF product is required for prophylactic therapy,     haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic     bleeding event.   "
158164|NCT01213433|"     This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of     AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.   "
158192|NCT01213069|"     The goal of this study is to evaluate the knowledge of paramedical and medical care personnel     concerning organ and tissue donations, as well as their opinions on this activity.   "
158165|NCT01213420|"     This study is a prospective, randomized controlled, double blinded, study in a multi centre     setting. Three burn centres will include 60 patients in total.      If suited for the study (= two equal donor sites) and after informed consent, patients will     be observed starting the day of skin prelevation.      A coded file will be made for each patient and these files should contain the localization of     both donor sites, their depth as determined by the setting of the dermatome and the     treatment. Treatment for both donor sites will always be equal.      The date of wound healing of each donor site, which may only differ by a maximum of five     days, will be noted. Digital photographs of the healed donor sites will be taken and the     scars will be evaluated by the local researchers using the Adapted Vancouver Scar Scale prior     to the start of hydration.      From that moment on one donor site will be treated with Aruba Aloe formula F-BC-096 while one     of the control products will be applied to the second site. Per group of five patients per     centre a different control product will be applied to the second donor site. The tubes     containing these products will be colour and numerical coded. Nor the treating personnel, nor     the patients will be informed which colour tubes contain the control products and which     contain the Aruba Aloe formula F-BC-096. If it is necessary to apply pressure garments for     one donor site, the garments will be applied for both sites.      Follow-Ups will be performed on one, three and six months after wound closure. Objective     methods will be used during these follow-ups to evaluate elasticity and colour of the scar,     this by using the Dermalab, the Cutometer®, the Derma Spectrometer and the Mexameter®. The     evaporation, permeability and hydration of the scar will be measured by using the Tewameter®     and the Corneometer®. The Reviscometer® will measure the direction of collagen and elastin.     The Adapted Vancouver Scar Scale will be used as a subjective method. Also different scales     for evaluation of donor site pain, patient satisfaction, product comfort, itching etc. have     to be completed by the patient.   "
158166|NCT01213407|"     A randomised, open-label, 2-arm, multi-centre, phase II clinical study with one group     receiving standard therapy with Temozolomide, radiotherapy, and Trivax; and a control group     receiving standard therapy with Temozolomide and radiotherapy only; after tumour resection of     at least 70% in both groups. The hypothesis is based on the assumption that time to     progression will be doubled in the treatment group.   "
158167|NCT01213394|"     The purpose of this research study is to determine if adding or increasing the dose of     CellCept while lowering the dose of tacrolimus (Prograf or Advagraf) or cyclosporine     (Neoral), and/or steroids can reduce the likelihood of developing coronary heart disease in     the next 10 years.      The investigators will calculate the change in risk of developing coronary heart disease     using the Framingham score. The Framingham score is a mathematical equation that includes the     following information: Age, Gender, Diabetes status, Smoking status, Lipids, Blood Pressure.     The Framingham score estimates how likely it is that someone will develop coronary heart     disease over the next 10 years.   "
158168|NCT01213381|"     Primary Objective:      - To determine a dose of SAR240550 to be further studied in combination with chemotherapy     regimens      Secondary Objectives:        -  To determine the dose limiting toxicity (DLT) of SAR240550 and SAR240550 in combination          with chemotherapy regimen (gemcitabine and carboplatin        -  To assess safety profiles: significant laboratory changes and adverse events (AEs)        -  To make a preliminary assessment of antitumor effect in study subjects per Response          Evaluation Criteria in Solid Tumors (RECIST) with measurable disease        -  To characterize SAR240550 and metabolites, 4-iodo-3-amino benzamide (IABM) and          4-iodo-3-amino-benzoic acid (IABA), pharmacokinetics        -  To collect blood samples for glutathione S-transferase (GST) genotypes at baseline)      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
158169|NCT01213368|"     Primary Objective:      - To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in     patients with permanent Atrial Fibrillation (AF).      Secondary Objective:        -  To assess the safety and tolerability of dronedarone after repeated oral doses of 300          mg, 400 mg, or 600 mg twice daily in the selected population.        -  To document SR33589 and SR35021 trough plasma levels at steady state.   "
158170|NCT01213355|"     It is hypothesized that PF-05212377 (SAM-760) will reverse scopolamine induced cognitive     impairments in healthy adults subjects.   "
158171|NCT01213342|"     Omega-3 fatty acids have been associated with a decline in inflammation. As dry eye disease     is associated with inflammation of the ocular surface (DEWS report, Ocular Surface, 2007),     the investigators hypothesize that the omega-3 fatty acid supplements used in this study will     help to improve dry eye signs, such as eye surface irritation (staining) and tear film     osmolarity, which is an overall measure of tear film stability and dry eye status. Further,     the investigators hypothesize that dry eye symptoms, the end result of dry eye disease, such     as discomfort and burning, will also improve with supplementation.   "
158172|NCT01213329|"     The purpose of this study is to check the T and B cells of the immune system in 50 newly     transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100     anticipated participants). This will be done to see how the Standard of Care (SOC)     anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H®     reduces the number of T cells produced by one's body. We will look for these cells using a     number of laboratory tests; It will require the subjects to each give 65mL of blood at each     of the 3 visits that occur during phase 1. Up to 12 subjects will be chosen from phase 1 to     participate in phase 2 depending on lab results.      In phase 2, subjects will be randomized to one of the three following groups:      Group one: Continue normal immunosuppression with tacrolimus and Cellcept® (control group)      Group two: Cellcept® will be tapered down to 70% in three months. Tacrolimus will be     continued at the same dosage.      Group three: Tacrolimus will be reduced to 70% in three months. Cellcept® will be continued     at the same dosage.      There will be an analysis of these cells at different time point, pre and post kidney     transplant. The data collection will allow us to study the stability over time of particular     phenotypes (cell structures) and T cell function. We will also evaluate how the two different     minimizing protocols effect the cell structure. Results from laboratory testing may allow     us to define certain criteria that can be broadly applied in solid organ transplant     recipients. This may allow for safe reduction of the anti-rejection medication that     transplant recipients receive.   "
158225|NCT01212640|"     OBJETIVES:        1. To research the worsening of respiratory status risk factors after transfusion in          spanish critical care units.        2. To determine the incidence of transfusion-related acute lung injury (TRALI) in          critically ill patients.        3. To research the morbi-mortality of TRALI.   "
168440|NCT00032994|"     The purpose of this study is to assess Motivational Interviewing (MI) to improve treatment     engagement and outcome in subjects seeking treatment for substance abuse.   "
158173|NCT01213316|"     This is an observational, non-comparative, multicenter, open-label study. Participants will     be treated with Raltegravir according to standard clinical practice, and monitored over a     total period of 96 weeks. In an extension to the study (Amendment 1), a new cohort of aging     participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks.     Participants who stop taking Raltegravir before the end of the 96-week period or 48-week     period, respectively, will be followed up for 3 months after discontinuing the drug. The     primary objective is to determine the proportion of participants with a human     immunodeficiency virus (HIV)-1 viral load < 50 copies/mL after 48 weeks of treatment with     Raltegravir.   "
158174|NCT01213303|"     Cardiovascular diseases belong to the major causes of mortality in western populations, and     atherosclerosis is the lesion responsible for clinical events, such as acute myocardial     infarction and stroke.      Atherosclerosis remains asymptomatic until a clinical event occurs, and in the pre-clinical     stage it may be difficult to diagnose. As disease surrogate, a large number of risk factors     for atherosclerosis are being recognized. Some of them are responsible for the     epidemiologically very serious metabolic syndrome, which accounts for development of     hyperlipidemia, obesity, diabetes or arterial hypertension.      Health providers in continental diet-based countries suggest to embracing Mediterranean diet     in order to contribute in reducing cardiovascular mortality. However, countries in the     Mediterranean area are experiencing a shift in dietary habit towards continental diet with     potential harmful change in mortality rates. Oxidative stress, including free radical-driven     reactions and antioxidant status are considered important mediators to be considered in the     diet-mediated effect on health. Important metabolic functions are also mediated by certain     fatty acids. A comprehensive study of oxidative stress, including free radical-driven     products and protective antioxidants, and fatty acids metabolism has never been reported in     healthy subjects. In particular, high sensitive mass-spectrometry methods to study oxidative     stress and fatty acids metabolism are rarely applied to epidemiological studies.      The aim of the present grant project is therefore to assess in a large cross-sectional study     the prevalence of oxidative stress markers, and fatty acids and to find any causal relation     between these variables and metabolic syndrome. This population sample will be followed     prospectively not only for time of the present grant project, but we would like to study     metabolic variables with relation to the development of oxidative stress-mediated diseases,     in particular those of cardiovascular system, on a longitudinal basis (prospective     epidemiological study for at least 10 years). At same time we should be able to define the     importance of individual markers of oxidative stress and fatty acids for early detection of     these diseases.   "
158175|NCT01213290|"     Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become an important tool in     the diagnostic evaluation of gastrointestinal tract lesions and other organ sites such as     mediastinal and intra-abdominal lymphadenopathy, pancreatic masses, liver masses, left     adrenal masses and gastrointestinal submucosal lesions. It provides crucial information that     can have tremendous impact on patient management. FNA is typically performed using a 22- or     25-gauge needle with a stylet under EUS guidance. The lesion is punctured with a stylet in     place in the needle. After withdrawal of the stylet, the needle is moved to and fro within     the lesion and this process is repeated for each needle pass. It is currently believed that     the use of a stylet for EUS-FNA improves the quality of specimens by preventing the tip of     the needle being clogged up with tissue and hence enhances the diagnostic yield of specimens     obtained. However, there are no data demonstrating clearly that the use of a stylet improves     the yield of EUS-FNA. The reason why this question is important is because the use of a     stylet during EUS-FNA is cumbersome, time and energy consuming and increases the costs of     EUS-FNA needle systems.      In this prospective randomized controlled trial, patients referred for EUS-FNA of mediastinal     and intra-abdominal lymphadenopathy, pancreatic mass, liver mass, left adrenal mass and     gastrointestinal submucosal tumors will be included. FNA will be performed with a 22-gauge     needle under EUS guidance using suction with a 10 mL syringe by two experienced     endosonographers. The technique to be used for fine needle sampling i.e. with a stylet in     place or without a stylet for each FNA pass will be assigned by using a preprinted     randomization scheme obtained from a sealed envelope and clearly documented. Each lesion will     be sampled for a minimum of four needle passes. The pathologists providing the final     interpretation will be blinded to technique of EUS-FNA (with or without stylet). The degree     of cellularity, contamination, amount of blood, adequacy of sample, frequency with which a     positive diagnosis is made will be compared between the two groups (EUS-FNA with stylet vs.     EUS-FNA without stylet). The sensitivity, specificity, accuracy, positive predictive value     and negative predictive value of each technique when compared to the final diagnosis will be     calculated. Inter-observer agreement among cytopathologists will be assessed for specimens     obtained from EUS-FNA with stylet and for those obtained from EUS-FNA without a stylet.   "
158176|NCT01213277|"     HbA1c is used as a gold standard to see whether patients have optimal glycemic control.     Today, many physicians rely solely on HbA1c to change medication. However, there is a select     group of patients that have low average glucose levels but high HbA1c levels. The     investigators believe that these patients are fast glycators meaning that they incorporate     sugar into their hemoglobin faster than normal. The investigators want to determine whether     these patients are fast glycators.   "
183513|NCT00245921|"     To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a     combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.   "
158177|NCT01213264|"     The intent of this observational study is to collect prospective data regarding neuromuscular     monitoring practices and extubation standards (Train-Of-Four [TOF] value) during surgery, in     countries of Central and Eastern Europe, Middle East and Africa (CEE/EEMEA countries).     Secondarily the study will observe, for which surgical procedures neuromuscular blocking     agents (NMBAs), and reversal agents to such, are used. This study is a non-interventional     clinical trial, and administration of NMBAs, and respective reversal agents, (as well as all     drugs used during anesthesia) will be done in accordance with routine anesthesiology     practice, and labeling guidelines. Neuromuscular transmission will be monitored according to     routine anesthesiology practice by means of acceleromyography. The assignment of the     participant to a particular therapeutic strategy is not decided in advance by a trial     protocol, but falls within current practice and the prescription of the medicine is clearly     separated from the decision to include the patient in the study.   "
158178|NCT01213251|"     The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent     adverse remodeling of the myocardium following an acute myocardial infarction (MI) in     patients at highest risk for adverse myocardial remodeling.   "
158179|NCT01213238|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to     patients with advanced cancer that has spread to the liver. The safety of these drug     combinations will also be studied.   "
158180|NCT01213225|"     Nursing home patients admitted to the hospital poses significant challenge for health care     providers. Geriatric teaching pays particular attention to these admissions and related     problems. However, it yet to be proven, that geriatric training helps to overcome any of them     in better way then non-geriatric education. The study aims to prove that geriatric care     provides advantages over non-geriatric training in caring for nursing home patients admitted     to the hospital.   "
158181|NCT01213212|"     The study investigates whether a caloric restricted dietary regime can prevent onset and/or     progression of chronic kidney disease in type 2 diabetic patients with abdominal obesity,     through the amelioration of concomitant metabolic abnormalities such as insulin resistance,     dyslipidemia, hypertension and inflammation, possible risk factors for the onset of kidney     disease.      The main aim of the study is therefore to evaluate the renoprotective effect of caloric     restriction (CR) on subjects at risk of nephropathy. Secondary aim is to better understand     how dietary implementation can modulate renal disease and its associated metabolic     abnormalities.   "
158183|NCT01213186|"     HIV-1 infection is characterized by progressive depletion of CD4+ T cells that eventually     leads to clinically significant immunodeficiency. A chronic generalized immune activation is     now being recognized to be the main driving force for T cell depletion, loss of anti-HIV-1     immunity and disease progression during chronic HIV-1 infection. However, it is still unknown     whether reducing immune activation will restore CD4 T cell counts and leading to immune     reconstitution in chronic HIV infection. Mesenchymal stem cells (MSC) have been demonstrated     to decrease immune responses of the host, and can suppress inflammation in HIV-infected     non-responders. Here, the investigators propose a hypothesis that MSC can reduce immune     activation which subsequently lead to the restoration of CD4 T-cell counts dependent on dose     of transfused MSCs in HIV-infected patients.   "
158184|NCT01213173|"     The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®)     (95 - 190 mg) on heart rate in the Stable angina patients.   "
158185|NCT01213160|"     The primary purpose of this study is to explore the safety and tolerability of AZD4547 in     Japanese patients with advanced solid malignancies.   "
158186|NCT01213147|"     Despite the progression in assisted reproductive technology (ART), the preferred protocol for     poor responders is still controversial. The management of poor responders consists of 10% of     ART cycles .      The response to controlled ovarian hyperstimulation (COH) is lower regarding estradiol level     , number of obtained oocytes , and fertilization , implantation and pregnancy rates in     patients with low ovarian reserve . Furthermore , bad quality embryos are observed in these     women more than normoresponders and the increase of cancellation rate and doses of     gonadotropin administration are remarkable results in poor responders . Several criteria have     introduced for poor responders , the main defect in the management of them is lack of     specific definition .Several strategies are available to improve ART cycles outcome in poor     responders. These modalities include using : high FSH dose , stop GnRH-agonist protocol ,     addition of growth hormone , transdermal testosterone , aromatase inhibitor , GnRH-antagonist     and recombinant FSH ( r-FSH) ; while the improvement of pregnancy rate has been quite low.      The most common used protocol for ovarian stimulation is microdose GnRH-agonist flare in poor     responders .Some investigators concluded that the use of GnRH-agonist  even in lower doses ,     led to prolonged stimulation and increased the cost without improving IVF outcome.     Furthermore this method increased LH , progesterone and androgen of serum in follicular phase     , which caused deleterious effect on follicular growth and oocyte quality .      Clomiphene citrate co-treatment with gonadotropin and antagonist are one of the recommended     protocol in poor responders . Clomiphene citrate increases endogenous FSH versus agonist in     microdose protocol. Decreasing the doses of used gonadotropin and duration of stimulation are     its beneficial effects in COH cycle .      The aim of this study was comparing CC/gonadotropin/antagonist and GnRH agonist flare     protocols on IVF outcome in poor responders .   "
158187|NCT01213134|"     Portfolios are the records of learning process, providing evidences of experiential learning.     It can be a valuable tool not only for understanding the learning process but also for     evaluating the accomplishment. Portfolios promote learners to reflecting, thinking, improving     in learning as well as achieving learning goals. It has been widely applied in medical     education. The goals of resident training outcomes in Wan-Fang Hospital are the ACGME six     core competences. The Wan-Fang hospital, one of Taipei Medical University affiliated     hospitals and the first implementing portfolio assessment teaching hospitals in Taiwan, will     conduct portfolio assessment to assess residents competences. Facilitating residents bring     reflective learning into practice, personal and professional growth and demonstrating the     outcomes of training program. This study describes initiating and implementing portfolio     assessment procedures. Qualitative and quantitative research methods are applied for     evaluating the portfolio assessment process and the data of validity and reliability.     Qualitative data collection methods of interview, focus groups and meetings will be used     understanding the experiences and viewpoints of residents, mentors and assessors. Then     quantitative data collection method of questionnaire will be subsequently used. The results     of this study will provide experiences and suggestions for the implementation of portfolio     assessment system in medical education.   "
158992|NCT01202591|"     The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination     with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy     (FISH4/5) or gene amplification (FISH 6)   "
158188|NCT01213121|"     -  To examine differences in neurophysiologic parameters between unmedicated patients with          bipolar depression and healthy controls        -  To examine within-subject changes in neurophysiologic parameters in patients with          bipolar depression treated with quetiapine   "
158189|NCT01213108|"     The Örebro prevention program is a brief (6 x 30 minutes)program administered to parents of     13-16 year old youths in regular parental meetings. The program aims to encourage parents to     maintain a restrictive attitude towards youth drinking throughout their children's teenage     years, and thereby postpone and reduce youth drinking. A previous quasi-experimental study by     the program developers showed a sustained alcohol-specific restrictivity among parents     exposed to the program, and also a reduction on drinking measures among the youths of the     exposed parents (Koutakis, Stattin & Kerr, 2008). This study aims to investigate whether     these effects are sustained also when the program has gone into wide dissemination in Sweden.   "
158190|NCT01213095|"     The clinical efficacy of rituximab, a chimeric monoclonal antibody targeted toward the B-cell     specific antigen CD20, was initially demonstrated in cases of follicular lymphoma (FL), but     the use of this antibody has been extended over the last few years to the majority of     subtypes of B-cell CD20 positive non-Hodgkin's lymphomas, with promising results thus far. In     MZL, small numbers of case reports have chronicled the use of rituximab as a single agent or     phase II trial combination with chemotherapeutic regimens.      The results of the rituximab maintenance phase III trial demonstrated that patients with FL     who continued to take rituximab monotherapy as a maintenance therapy after responding to an     initial course of chemotherapy combined with or without rituximab experienced longer     progression-free survival durations than did those who received no rituximab maintenance     therapy. The efficacy of maintenance treatment after first-line induction treatment with     R-chemotherapy was addressed in the international PRIMA (Primary Rituximab and Maintenance)     study, which has enrolled 1,217 patients. The first results are eagerly awaited. Although MZL     has better prognosis in TTP and OS than FL, both of them are classified as the same category     of indolent lymphoma -characterized by frequent relapse and prolonged survival.      According to the results of our survey, advanced stage MZL tends to be an indolent disease -     characterized by prolonged survival with frequent relapses. Rituximab appears to contribute     to better responses, but not in TTP. Thus, we should consider maintenance treatments for MZL     patients, to extend their response duration.   "
158191|NCT01213082|"     The purpose of this study is to test the hypothesis that proton beam irradiation combined     with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal     anti-VEGF therapy alone in eyes with exudative age-related macular degeneration.   "
158193|NCT01213056|"     The literature on the efficacy of Cognitive Behavioral Therapy (CBT) for the treatment of     chronic pain is well established. Support for the efficacy of Mindfulness Based Stress     Reduction (MBSR) and other mindfulness based treatments for chronic pain is building.     Recently, research has demonstrated the efficacy of Mindfulness Based Cognitive Therapy     (MBCT) in simultaneously addressing the outcome variables targeted by both CBT and     mindfulness based treatment modalities. Although the efficacy of MBCT depression and for     other populations has been investigated, there is no extant literature reporting on MBCT for     chronic pain. The current application proposes to investigate the feasibility and efficacy of     an MBCT protocoll adapted for chronic pain in a series of pilot groups with headache pain     patients. We selected headache pain patients for this trial because headache pain is a common     complaint in the general population, is the most frequently reported cause of pain in medical     practice, and is one of the most disabling conditions for both genders combined. To examine     the feasibility of the adapted protocol, the investigators will investigate a number of     treatment related outcomes such as recruitment, completion, and drop out rates. Both primary     and secondary outcome variables will be investigated to determine treatment efficacy.      This study will provide a research base examining the feasibility and efficacy of MBCT for     pain. Results from this study will lay the foundation for future randomized controlled trials     comparing MBCT to attention control, and future comparative effectiveness studies of MBCT and     CBT.   "
158194|NCT01213043|"     This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of     Prolastin-C (alpha1-proteinase inhibitor [alpha1-PI] [Human]), compared to weekly infusions     of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).   "
158195|NCT01213030|"     Positron Emission Tomography (PET) with fluorine-18 fluoromisonidazole (FMISO) has been used     for several years as a non invasive imaging technique to study tumor hypoxia. Several     experimental and clinical studies have indicated that FMISO uptake of tissues is correlated     with tissue oxygen tension and that FMSO PET allows non-invasive differentiation between     hypoxic and normoxic tumors. Currently, FMISO-PET represents the best characterized and     validated noninvasive hypoxia imaging technique. Nevertheless, clinical studies have also     shown the limitations of FMISO PET. Accumulation of FMISO in hypoxic tumors is relatively     low, resulting in a low contrast between hypoxic tumors and surrounding normal tissues. In     addition, imaging needs to be started relatively late after tracer injection (about 3 hours     post-injection), when a significant percentage of the fluorine-18 label has already decayed     and the count statistics of the PET images are relatively low. Because of these limitations,     FMISO PET is still only used at a few research centers, despite high clinical interest in     hypoxia imaging.   "
158196|NCT01213017|"     The purpose of this study is to determine whether Certolizumab pegol can rapidly reduce the     inflammatory changes and inhibit erosions on hand and wrist MRI in patients with active     moderate to severe rheumatoid arthritis.   "
158197|NCT01213004|"     Tumors must be seen clearly on CT scan to be radiated completely and safely. Breathing causes     tumors to move. If the tumor moves during breathing, it can look blurred on the CT scan. This     makes it difficult to see on CT scan. The investigators wish to investigate whether a new     computer method makes tumors less blurry and easier to see on CT scan. Cone-beam CT is a type     of CT scanner attached to the radiation treatment machine that produces 3D images of the     patient. Since your tumor can move because of your normal breathing, it is often blurry and     difficult to see accurately in a standard cone-beam CT scan. The investigators intend to use     a computer method which processes the cone-beam CT data in a way that reduces the blurring     and makes the tumor easier to see.   "
158198|NCT01212991|"     The purpose of this study is to determine the benefit of enzalutamide versus placebo as     assessed by overall survival and progression-free survival in patients with progressive     metastatic prostate cancer who have failed androgen deprivation therapy but not yet received     chemotherapy.   "
158199|NCT01212978|"     The American Heart Association (AHA) and American College of Sports Medicine (ASCM) recommend     older adults (50≤ age ≤ 80) perform at least 30 minutes of moderate-intensity aerobic     exercise on most days ( ≥5 days) of the week. This suggestion arises, in part, from data     supporting that regular physical activity reduces the risk of adverse cardiovascular events A     portion of these benefits may be from reductions in the incidence and severity of     cardiovascular risk factors, including diabetes mellitus, obesity, and hypertension.      While this recommendation for physical activity has been in existence for almost 15 years,     the rates of obesity in the United States continue to rise and prevalence of sedentarism     remains at best unchanged. Researchers have been engaged in investigating novel interventions     to designed increase physical activity to reach the recommended activity targets. One     promising intervention involves use of inexpensive, easy to use pedometers that allow     individuals to objectively track the number of steps taken during a set period of time.     Recent data suggest that an average of 10,000 steps/day as measured by a pedometer accurately     estimates the activity levels recommended by the AHA, ASCM, and US government public health     guidelines.      While the benefits of habitual exercise are well-documented, there are no data that     demonstrate current recommendations for moderate physical activity in older adults by the     ASCM, AHA, and US public health guidelines reduce the risk of adverse cardiovascular events.     Interestingly, prior work indicates that pedometer-centered interventions can increase     physical activity, suggesting that this type of intervention could potentially lead to     cardiovascular benefits. Using validated surrogate markers of cardiovascular risk including     brachial artery endothelial function, tonometric measurements of vascular stiffness, and     measurements derived from transthoracic echocardiography, we will determine whether     increasing the physical activity of sedentary adults to an average of 10,000 steps or     more/day translates into improvements in cardiovascular health. This will be determined in     the context of a randomized control trial employing a control group, a study group that uses     a pedometer alone, and an intervention that couples a pedometer with internet-based     motivational messaging software demonstrated in our preliminary data to encourage older     adults to reach and exceed the 10,000 steps/day goal.   "
158200|NCT01212965|"     The investigators propose a pilot trial to obtain preliminary information regarding the     safety and response rate of patients with symptomatic lymphatic malformations treated with     oral Selenium. Information obtained in this pilot trial will be used to plan future phase 2     clinical trials.      Hypotheses:        -  Selenium will be safe and efficacious in the treatment of adolescents and young adults          with symptomatic lymphatic malformations        -  Disease response will correlate with serum levels of selenium and blood levels of          antioxidants essential to selenium metabolism.   "
158226|NCT01212627|"     The main purpose of this study is to evaluate the best dose, safety and side effects of     ridaforolimus when given with cetuximab for patients with head and neck, lung and colon     cancer that has progressed after initial therapy. A second purpose of this study is to gain     preliminary information on whether the combination of ridaforolimus and cetuximab is helpful     in treating patients with advanced head and neck cancer   "
159264|NCT01199029|"     This study will investigate the effect of a single dose of PF-04308515 or prednisone on     calculated measures of glucose tolerance and insulin resistance by using a modified oral     glucose tolerance test.   "
158201|NCT01212952|"     RATIONALE: Pomalidomide and bortezomib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Bortezomib may also stop the growth of tumor cells by     blocking blood flow to the tumor. Drugs used in chemotherapy, such as dexamethasone, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving pomalidomide and bortezomib together with dexamethasone may kill     more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose     of bortezomib when given together with pomalidomide and dexamethasone and to see how well it     works in treating patients with relapsed or refractory multiple myeloma.   "
158202|NCT01212939|"     When root canals of infected teeth with closed ends are cleaned, disinfected and filled, the     results are predictable with excellent outcomes. However, in a tooth with incomplete root     development, the end of the root(s) must be closed before filling the root canals. One or     two-step artificial barrier using mineral trioxide aggregate (MTA) has been used before     filling the root canals of these teeth. Despite the high success of this treatment, this     procedure does not result in complete root formation and these teeth are susceptible to root     fracture. A number of case reports in scientific journal have shown the possibility for     regeneration of nerve within the root canal space and continued root development in teeth     with dead nerves and open ends. There is very little information regarding the use of stem     cells and growth factors from the blood of patients to regenerate the nerves in these teeth.     Platelet rich plasma (PRP) from whole blood has been mentioned in the literature as a     potential ideal material for regeneration of nerves in these teeth. The purpose of this study     is to investigate the use of PRP to regenerate tooth nerve and close the root ends in teeth     with root canal infection and open root ends.   "
158203|NCT01212926|"     It is now accepted that the anticancer properties of anthracyclines were allowed in many     malignancies improve the prognosis of affected populations.      However, the cardiotoxicity of anthracyclines is responsible for an interruption of this     treatment by alteration of potentially irreversible myocardial contraction and high     mortality.      An earlier detection of adverse myocardial anthracycline chemotherapy would allow the     adaptation of the regimen by reducing the number of interruptions of antitumor and     strengthening monitoring. Optimizing the therapeutic antitumor and generate an increase in     survival of patients treated.   "
158204|NCT01212913|"     Primary Objective:      To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between     the basal plus one and the biphasic insulin regimen.      Secondary Objective:      To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to     comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event     is taken into account.   "
158205|NCT01212900|"     Background:      - Atherosclerosis (thickening of the artery walls caused by cholesterol and other deposits)     commonly occurs in the heart vessels and carotid (neck) arteries of adults. This is often     present in individuals with high cholesterol levels in their blood. These patients are     usually treated with cholesterol lowering medication ( statins ) along with modification of     diet and exercise. Researchers are interested in investigating new approaches including     magnetic resonance imaging (MRI) and computed tomography (CT) imaging studies to detect blood     vessel blockages that would not otherwise be detected by cholesterol levels and risk factors     for heart disease.      Objectives:      - To measure atherosclerosis in the heart vessels and carotid arteries using imaging tests     (computed tomography (CT) and magnetic resonance imaging (MRI)) before and after standard     treatment with cholesterol lowering medication ( statins )      Eligibility:      - Healthy individuals at least 55 years of age who are candidates for therapy to lower their     blood cholesterol levels.      Design:        -  This study will involve one screening visit and seven study visits over a period of 2          years.        -  Participants will be screened with a physical examination and medical history, as well          as blood samples and tests to ensure that it is safe for them to have CT and MRI scans.          Participants will provide information on current medications, dietary habits, smoking          status, alcohol and caffeine intake, and their level of physical activity.        -  Participants will be divided into two groups. One group will receive standard doses of          medication to lower cholesterol according to current treatment guidelines, while the          other group will have MRI scans of the carotid arteries and a CT scan of the heart to          determine the best medication dose levels.        -  Visits 3 to 5 will be scheduled 3, 6, and 9 months after visit 2. During these visits,          researchers will monitor for possible side effects and may change or adjust medications          and doses.        -  At visit 6, participants will have an MRI scan of the carotid arteries, a physical          examination, and blood tests. Medications may be changed or adjusted.        -  At visit 7, participants will have blood tests, and medications may be changed or          adjusted.        -  At the final visit, participants will have MRI and CT scans of the carotid arteries and          heart, respectively, as well as a final physical examination and blood tests.   "
158628|NCT01207362|"     The purpose of this study is to compare current standing balance assessment methods to a new     method that measures weight shift during small movements of a sliding platform. It will also     be used to determine if balance improves with repeated exposure as part of a 4-week training     program.   "
158206|NCT01212887|"     RATIONALE: Placing a gene into T cells may improve the body's ability to recognize cancer     cells and build an immune response to fight cancer. Drugs used in chemotherapy, such as     cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Biological     therapies, such as aldesleukin, may stimulate the immune system in different ways and stop     cancer cells from growing. Giving specially treated T cells together with cyclophosphamide,     fludarabine phosphate, and aldesleukin may kill more tumor cells.      PURPOSE: This phase I clinical trial is studying the side effects and best dose of treated T     cells when given together with cyclophosphamide, fludarabine phosphate, and aldesleukin in     treating patients with cancer.   "
158207|NCT01212874|"     This is an investigator initiated, sponsored, open label, prospective randomized controlled     trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will     be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that     occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary     bypass (CPB).   "
158208|NCT01212861|"     The primary objective of this study is to evaluate the safety, efficacy, and performance of     the Suprachoroidal Dissection Instrument in creating a fistula between Schlemm's canal and     the suprachoroidal space in refractory, open angle glaucoma subjects.   "
158209|NCT01212848|"     The purpose of this study is to determine whether transcranial magnetic stimulation (TMS) is     effective in the treatment of suicidal thinking in individuals with a depressive episode and     either posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (TBI), or     both conditions.   "
158210|NCT01212835|"     Silastic rings have been used around the gastric pouch in order to promote better weight loss     after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown that     some patients developed gastroesophageal reflux disease after RYGBP in a previous study. The     investigators hypothesized that the use of a silastic ring may play a role in promoting GERD     after this operation.   "
170320|NCT00059709|"     This study will evaluate the effectiveness of conflict resolution training for families with     preschool and elementary school-aged children.   "
158211|NCT01212822|"     This pilot phase II trial studies how well giving bevacizumab and combination chemotherapy     together before surgery works in treating patients with locally advanced esophageal or     stomach cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Drugs used in     chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed. Giving these     treatments after surgery may kill any tumor cells that remain after surgery.   "
158212|NCT01212809|"     This study is being done to evaluate the differences in the performance of two well known     injectable dermal fillers commonly used for the cosmetic treatment of age lines above the     lips and on the cheeks when compared to each other in the same patient. The products being     tested are Juvéderm® Ultra and CosmoDerm® 1.   "
158213|NCT01212796|"     The allogeneic hematopoietic stem cell marrow is the only curative treatment for many     hematologic malignancies. However, many patients relapse in these situations to be     therapeutic possibilities scarce and mixed. Chemotherapy in these situations does not show     good results and new drugs have not yet demonstrated the effectiveness desired.      Another therapeutic approach after relapse post allogeneic transplant is to resubmit the     allogeneic transplant patient to patient. In this clinical situation is little known. All     previous studies are retrospective, the data provided are of little statistical value and     heterogeneous patient samples.      The GETH (Grupo Espanol de trasplantes hematopoyeticos y terapia celular) has included in its     database a figure around 350 seconds allogeneic transplants. Comparing this with the studies     published so far, this would be the largest retrospective series published size compared to     second allogeneic transplants.   "
158214|NCT01212783|"     The purpose of this study is to determine the efficacy of In-Home Cognitive Behavioral     Therapy (IH-CBT) in comparison to Present-Centered Therapy (PCT), a supportive therapeutic     approach. IH-CBT is adapted form of CBT that is provided to depressed mothers participating     in ongoing home visitation services. IH-CBT has been adapted to fit the setting, population,     and context associated with home visiting. Mothers are recruited at 4 months postpartum. A     comprehensive assessment battery is administered at pre-treatment, post-treatment, and 6, 12,     and 18 months after the end of treatment. It is hypothesized that IH-CBT will be superior to     PCT in decreasing depression, improving overall functioning, enhancing parenting     effectiveness, and preventing relapse.   "
158215|NCT01212770|"     The purpose of this study is to determine whether apremilast is safe and effective in the     treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.      Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and     swollen joints, pain, physical function) in treated patients.   "
158216|NCT01212757|"     The purpose of this study is to determine whether apremilast is safe and effective in the     treatment of patients with psoriatic arthritis.      Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and     swollen joints, pain, physical function) in treated patients.   "
158217|NCT01212744|"     The purpose of this study is to evaluate the effect of daily administration of rAvPAL-PEG on     the reduction of blood Phe concentrations in subjects with PKU.   "
158218|NCT01212731|"     The purpose of this study is to:        -  estimate the degree of memory loss, if any following radiotherapy to the base of skull          or brain as measured by standard neurocognitive battery testing.        -  describe radiotherapy dose-related changes in vascular perfusion, in spectroscopic          parameters of neuronal injury and changes in the degree and directionality of tissue          water diffusivity (diffusion tensor imaging) as a measure of white axonal injury.        -  to relate these imaging characteristics to the degree of memory loss.   "
158219|NCT01212718|"     The aim of the study was to evaluate the feasibility of TS determination in a multicenter     trial setting using a central facility for measurement and confirm its role as predictive     factor for 5-FU treatment in MCRC.   "
158993|NCT01202578|"     The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube     Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.   "
158220|NCT01212705|"     Sleep disordered breathing is common in patients with chronic heart failure. Adaptive     servoventilation is a novel method of treatment central sleep apnoea, especially associated     with Cheyne-Stokes-respiration. The aim of the study is to investigate effect of adaptive     servoventilation on cardiac function, exercise tolerance and quality of life in patients with     chronic heart failure.   "
158221|NCT01212692|"     The purpose of this study is to learn if activities that challenge the brain (mentally     stimulating activities) can improve memory and other types of thinking in patients with Mild     Cognitive Impairment. The study will compare the effects of different methods of mental     stimulation.   "
158222|NCT01212679|"     Traumatic bain injury(TBI) remains a hidden epidemic involving individuals affected     predominantly at a young age who in the most severe cases remain with permanent     physical,psychological and cognitive deficits.This study will investigate the therapeutic     effects of intranasal Nerve Growth Factor(NGF) in TBI.   "
158223|NCT01212666|"     The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo     when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.   "
158224|NCT01212653|"     1. To determine the effect of Golimumab treatment on the number and function of Endothelial          Progenitor Cells (EPCs) in Ankylosing Spondylitis(AS) patients as a possible mechanism          for the effect of this treatment on endothelial function.        2. To ascertain the effect of Golimumab treatment on , carotid intima-media thickness,          vascular stiffness in Ankylosing Spondylitis(AS) patients as measured by pulse wave          velocity (PWV) and Augmentation index (AIx).        3. To assess the clinical efficacy of Golimumab in Chinese Ankylosing Spondylitis(AS)          patients according to ASAS response criteria at month 3, 6 and 12.        4. To perform cost-effectiveness and cost-utility analyses of the Golimumab in Ankylosing          Spondylitis(AS) patients, using clinic-base data.   "
170321|NCT00059722|"     The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with     NSCLC after Failure of Prior Platinum-based Chemotherapy.   "
158227|NCT01212614|"     This study bases on the successfully completed project SNF 320000-112006 (EK 1152 and     SwissMedic 2005dr2207e) and will document the physiological effects of inhibited gastric     secretion on the volume as well as the acidity of gastric secretion by high dose proton pump     inhibitors in GERD patients and healthy controls. Twelve participants in each group will be     studied in a randomized, double-blind placebo controlled trial. A novel non-invasive MRI     technique developed in Zurich will assess the volume of gastric secretion following the     ingestion of a regular liquid meal. In addition, intragastric / esophageal pH monitoring will     assess the link between volume and intragastric distribution of gastric secretion on reflux     events and symptoms. In addition, the effect of gastric secretion on outcome parameters of a     non-invasive stable isotope breath test for measurement of gastric emptying will be assessed.   "
158228|NCT01212601|"     This is a Multicenter, observational, non-interventional registry designed to collect     clinical data in Chinese patients who have received CUBICIN treatment under condition of     actual usage in clinical practice.   "
158229|NCT01212588|"     Participants will be randomized to either Mifepristone 600mg once daily for seven days or     Placebo tablet once daily for seven days. Rating scales, vital signs, cortisol levels will be     collected for evaluation.   "
158230|NCT01212575|"     The primary objective of this non-interventional study is to investigate how Seroquel XR and     Seroquel IR are used in the clinical practice of outpatients with schizophrenia. This will be     done by a retrospective review of medical records to evaluate patients treated with Seroquel     XR or Seroquel IR as primary antipsychotic treatment.   "
158231|NCT01212562|"     The purpose of this study is to evaluate the efficacy of cryosurgery during continuing     imiquimod application in the treatment of basal cell carcinoma of the skin.   "
158232|NCT01212549|"     To compare the effectiveness of two application schemes of cryosurgery during a 5 week course     of topical imiquimod i.e. cryosurgery at the end of the second week of imiquimod followed by     3 more weeks of imiquimod (immunocryosurgery) versus cryosurgery at day 0 followed by 5 weeks     of topical imiquimod (cryoimmunotherapy)   "
158233|NCT01212536|"     The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope     with conventional direct laryngoscopy for tracheal intubation in a randomised crossover study     during routine anaesthesia. The investigators hypothesise that the Airtraq is as good as     conventional laryngoscopy for tracheal intubation of infants and children. This will be an     equivalence rather than a non-inferiority study.   "
158234|NCT01212523|"     The investigators hypothesize that there is no difference between the effects of isoflurane     and propofol anaesthesia on pulmonary vascular resistance (PVR).   "
158235|NCT01212510|"     The primary purpose of the study is to confirm the results of previous study about the     usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in     patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The     secondary purpose is to evaluate the value of circulating free mutant DNA and circulating     tumor cells (CTC) and their variations during the treatment.   "
158236|NCT01212497|"     Evaluate the effectiveness of using a virtual computer coach to provide mindfulness     meditation training, and the coaching support required to initiate a regular practice.   "
158322|NCT01211379|"     The investigators overall goals are to adapt, implement, evaluate, and disseminate the     FLU-FOBT Program as an integrated nurse-run, primary care-based intervention that can reduce     colorectal cancer screening disparities in resource-poor clinical settings. In this program,     fecal occult blood tests (FOBT) are provided with influenza vaccinations (FLU) to eligible     patients between the ages of 50 and 75 during FLU season. The investigators hypothesis is     that the FLU-FOBT Program can be adapted for primary care settings and lead to higher rates     of colorectal cancer screening (CRCS).   "
158237|NCT01212484|"     This is a pilot clinical trial of carbidopa to treat disabling attacks of nausea and vomiting     in patients with familial dysautonomia (FD, also known as Riley Day syndrome or hereditary     sensory and autonomic neuropathy type III). FD is a rare autosomal recessive disease in which     the growth and development of selective nerves is impaired. Patients with FD suffer recurrent     uncontrollable nausea and vomiting crises accompanied by skin flushing, tachycardia and     arterial hypertension. Current treatments of nausea are ineffective or have intolerable side     sides. Our long-term goal is to treat nausea effectively and without side effects, a     therapeutic intervention that would markedly improve the quality of life of patients with FD.      The investigators have recently found that resting plasma dopamine levels are high in     patients with FD and increase up to 40-fold during nausea and vomiting attacks. This led us     to postulate that stimulation of dopamine receptors in the chemoreceptor trigger zone of the     brainstem is the likely mechanism of vomiting.      Carbidopa is a reversible competitive inhibitor of aromatic L-amino acid decarboxylase (also     known as dopa-decarboxylase) that cannot cross the blood brain barrier. It has been used     successfully for many years to block the extracerebral synthesis of dopamine and avoid nausea     and vomiting in patients with Parkinson's disease taking levodopa. The investigators reasoned     that carbidopa could have a similar antiemetic effect in patients with FD.      The investigators propose to conduct a pilot trial to assess the safety, tolerability and     efficacy of carbidopa for the treatment of nausea in patients with FD. The pilot trial will     recruit 25 patients with FD who complain of severe nausea that affects their quality of life.     The trial will be divided into two consecutive, but independent parts. Part 1, will address     the safety and tolerability of carbidopa in patients with FD using an open-label dose     titration phase followed by 4-weeks of open-label treatment. Part 2, will address the     efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized,     placebo controlled, double blind, 4-week cross over design.      The investigators hope to demonstrate that carbidopa is a safe, well-tolerated drug that     blocks the peripheral formation of dopamine and thus prevents dopamine-induced nausea and     vomiting attacks in patients with FD.   "
158238|NCT01212471|"     A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry     eye disease.   "
158239|NCT01212458|"     Untersuchungen über die Wirkmechanismen von Antiepileptika haben gezeigt, dass durch eine     Blockierung von spannungsabhängigen Natrium-Kanälen im Nervensystem die Schmerzübertragung     moduliert werden kann. Verschiedene Antiepileptika werden in der chronischen Schmerztherapie     schon lange angewendet (z.B. Oxcarbazepinum, Trileptal ® bei Trigeminusneuralgie oder     diabetischer Polyneuropathie).      In unserer Untersuchung wollen wir zwei in der Schweiz zugelassene Antiepileptika bezüglich     ihrer Wirkung auf das Schmerzempfinden untersuchen. Eines dieser Medikamente, Trileptal®     (Wirkstoff: Oxcarbazepinum), wird schon häufig bei chronischen Schmerzzuständen eingesetzt.     Das zweite Medikament, Inovelon® (Wirkstoff: Rufinamid) ist seit mehr als einem Jahr in der     Schweiz zugelassen und wird klinisch vor allem in der Behandlung von besonderen     Epilepsieformen im Kindesalter eingesetzt. Wir erwarten, dass auch nach Gabe von Inovelon®     die Schmerzleitung in den Nervenzellen verändert und die lokalen Schmerzreaktionen in der     Haut vermindert werden.        -  Trial with medicinal product   "
158473|NCT01209416|"     This study will investigate the non-growth-hormone-dependent metabolic effects of the hormone     Ghrelin in growth hormone deficient subjects by examining the insulin tolerance as well as     signal proteins in fat and muscle biopsies.   "
158240|NCT01212445|"     The primary objective of the study was to evaluate the proportion of subjects with a bowel     movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of     treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus     Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses     of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported     BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM     control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.      In addition, the proportion of subjects with a BM (without straining and without hard and/or     lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E     was evaluated for the time to first BM.   "
158241|NCT01212432|"     Daptomycin kinetics in CRRT        -  Trial with medicinal product   "
158242|NCT01212419|"     Objectives: Sleep characteristics have been used for prediction of neuro-developmental     outcome. The aim of our study was to evaluate the influence of morphine and midazolam on the     development of SWC in newborns > 32 weeks' gestational age after major non-cardiac surgery.      Study design: This prospective aEEG study included infants > 32+0 weeks' gestation admitted     to the Neonatal Intensive Care Unit at The Royal Children's Hospital in Melbourne who were     undergoing major non-cardiac surgery. The BrainZ Monitor (BRM2, Version 8.0, BrainZ     Instruments, New Zealand) was applied post-operatively. The time of onset and quality of SWC     and the maximum levels of morphine and midazolam as predictors of time to SWC were then     assessed.      Results: Forty-seven eligible infants were included. Emergence of SWC was observed at a mean     of 13 hours post-surgery. The maximum dose of morphine or midazolam was not predictive of     time to SWC.      Conclusions: Despite high doses of continuous infusions of morphine and midazolam SWC was     observed on aEEG in neonates > 32 weeks' gestational age soon after major non-cardiac     surgery. The main type of aEEG background pattern was not affected by the maximum dose of     either morphine or midazolam. Abnormalities in aEEG in post-surgical patients are not always     drug related.   "
158243|NCT01212406|"     Vitamin D deficiency occurs in around 50% of our transplant population. Preventive treatment     with Vitamin D (D-cure) can reduce the prevalence of Bronchiolitis Obliterans Syndrome after     lung transplantation   "
158244|NCT01212393|"     The appropriate use of thromboprophylaxis in medical patients admitted to hospital can     substantially reduce the overall burden of disease due to venous thromboembolism. However,     the use of thromboprophylaxis in medical setting appears to be generally poor leaving at-risk     patients unprotected.      We aim to analyse the incidence of symptomatic thromboembolic disease following     hospitalisation in medical setting and the efficacy of a multicomponent prevention approach     in emergency department including systematic evaluation of thrombosis risk factors and     remembers of thrombophylaxis indications and modalities for acutely ill medical patients.      Design: cluster randomized interventional study - Observational study at patient level      Setting: 30 French emergency departments      Patients: Patients over 40 years old admitted in participating emergency departments and     hospitalized for acute medical reasons.      Main judgment criteria: the rate of symptomatic thromboembolic events and severe haemorrhage     during a formal 3-months follow-up after hospital admission in patients hospitalized at least     48 hours.   "
158245|NCT01212380|"     RATIONALE:      Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth.      PURPOSE:      This phase I trial is studying the side effects and the best dose of carfilzomib in treating     patients with relapsed or refractory chronic lymphocytic leukemia(CLL),small lymphocytic     lymphoma(SLL), or prolymphocytic leukemia (PLL).   "
158246|NCT01212367|"     This research will study how to activate the immune system by using gene transfer. Gene     transfer involves inserting a specially designed gene into cancer cells. A gene is a part of     the genetic code that instructs the cells of our bodies to produce specific compounds     (proteins) important for the makeup or function of the cell. The study hypothesis is that     repeated doses of SCH 721015 given over a three day interval would result in gene transfer.   "
158247|NCT01212354|"     The major clinical problem and predominant cause of death after radio-oncological treatment     of H+N cancers are loco-regional relapses. This randomized trial tests the hypothesis that     dose escalated Intensity Modulated Radiotherapy (IMRT) selectively applied to the macroscopic     primary tumor and involved neck nodes - which both in 80% - are hypoxic improves     loco-regional control by at least 15% at 2 years. IMRT is combined with concurrent Cis-Platin     chemotherapy. Tumor volume which correlates with number of malignant cells as well as tumor     hypoxia are important biological parameters which increase radio-resistance, failure of local     control and tumor progression. Basing on data of experimental and clinical radiation oncology     we consider hypoxia as a useful parameter for pre-therapeutic strati-fication in future     randomized radio-chemotherapy trials.      In addition, hypoxia imaging by PET can be used for testing the significance of selective     dose escalation on hypoxic tumor sub-volumes (Dose Painting).      As a prerequisite for such innovative studies addressing hypoxia the translational part     investigates the following key issues: correlation between the size of total tumor volume     (primary, lymph nodes) and hypoxic sub-volume, the spatial shift of the hypoxic sub-volume     before start of treatment and the correlation of loco-regional control and hypoxia.      Before starting the main study a pre-study to assess the occurrence of radiation induced     toxicities is mandatory to be performed. In a step-wise dose-escalation in a cohort-design     the safety of dose-escalation should be determined. Step one: 6 patients Step two: 14     patients. In the pre-study the 1st group (6 patients) should be treated with 2.2 Gy up to     77.0 Gy for DEVPT and DEVLK. After evaluation of the toxicity the next 14 patients should be     treated by this scheme.   "
158248|NCT01212341|"     Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who     underwent leukapheresis. These cells were processed based on a novel method for ex vivo     activation and expansion using an irradiated and activated autologous feeder cell system.     MG4101 has anti-tumor activities against various tumors including malignant lymphomas in     vitro as well as in vivo tumor model.   "
158282|NCT01211899|"     Data on 4G/5G polymorphism of plasminogen activator inhibitor-1 (PAI-1) gene are limited in     Asian patients with sepsis. Therefore, the investigators aim to prospectively investigate the     incidence of 4G/5G polymorphism and its relationship with disseminated intravascluar     coagulatin in patients with severe sepsis and septic shock.   "
158249|NCT01212328|"     Background: Cardiovascular diseases (CVD) are currently the leading cause of death globally     and Asian Indians will account for between 40-60% of the global CVD burden within the next     10-15 years. Risk factor control and preventive care are effective in reducing CVD events and     mortality. The greatest gains in CVD prevention have been seen when early and target-driven     interventions address multiple risk factors together. However, achieving control of even     individual risk factors (blood glucose, blood pressure, or blood lipid targets) is poor,     globally. Quality improvement schemes, like the proposed intervention, have shown promise in     high-income countries, but are untested in South Asia; a region with a population at     extraordinarily high CVD risk.      Objective: To test whether a clinic-based case management intervention (consisting of     guidelines based treatment, care coordinator assistance and decision support software) to     reduce cardiovascular disease (CVD) risk among Type 2 diabetes patients in South Asia, is     more effective and sustainable compared to existing care.      Trial subjects and methods: The study will involve a total of 1120 patients attending 8     established out-patient clinics in South Asia (140 patients at each clinic). Patients     enrolled in the trial will be randomly assigned to either the control (existing care) or the     intervention group and will be followed up for an average of 30 months. The total trial     duration is about 3.5 years, from mid-August 2010 to December 31, 2013.   "
158250|NCT01212315|"     The purpose of this study is to assess if triclosan-coated sutures reduces wound infections     after saphenous vein harvesting in CABG patients. Secondary objectives are the effect     triclosan-coated sutures on sternal wound infections and a cost analysis.   "
158251|NCT01212302|"     Dual antiplatelet therapy with acetylsalicylic acid (ASA, aspirin) and clopidogrel is of     great importance for treatment following coronary stenting. Unfortunately the variable     platelet inhibitory effectiveness compromises the antithrombotic benefit of dual antiplatelet     therapy. The aim of this prospective single centre study was to reduce the low response     incidence of dual antiplatelet therapy with ASA and clopidogrel based on a standardized     therapy algorithm.   "
158252|NCT01212289|"     Cardiac surgery requiring use of a heart-lung machine, also known as cardiopulmonary bypass     (CPB) can induce abnormalities in blood coagulation (clotting) that lead to excessive blood     loss during and after operation. While of significant concern in adults, this problem takes     on even greater importance in children due to the simple fact that they have a smaller blood     volume. It is well known that if a child has previously undergone a heart operation, they are     at increased risk of bleeding should more cardiac surgery be required (reoperation). The     processes regulating blood coagulation are extraordinarily complex, and little is known about     the exact mechanisms that contribute to the increased bleeding associated with cardiac     reoperation in children. Rotational thromboelastometry (ROTEM®) is a technology that can     provide, at the bedside, detailed information about coagulation abnormalities. While not     currently approved for general use in the United States, in Europe ROTEM® has been used to     guide administration of the blood products in surgery based upon determination of specific     coagulation abnormalities. Importantly, there is now evidence that guidelines for transfusion     therapy based on ROTEM® reduce transfusion requirements thus decreasing patient exposure to     blood products. Whether the use of ROTEM® has potential benefit for pediatric cardiac     surgical patients has not been studied. Accordingly, the present study was designed to     provide preliminary data comparing coagulation profiles between children undergoing cardiac     reoperation to those having primary procedure.      The investigators hypothesize that ROTEM® analysis will detect a pattern of impaired     coagulation in children undergoing reoperation. The overall objective of the four assays of     ROTEM® analysis therefore, is to provide information that can be used to devise a rational     transfusion protocol for pediatric cardiac surgical subjects.   "
158253|NCT01212276|"     The purpose of this study is to evaluate whether therapy with MORAb-028 is safe, effective,     and to determine the appropriate dose of MORAb-028 in the treatment of metastatic melanoma.   "
158254|NCT01212263|"     To test whether adding small doses of HP urinary FSH to standard regimen of clomiphene     citrate in clomiphene resistant PCOS well yield better results in terms of better ovulation     rate,lower follicle number, less consumption of HP urinary FSH,lower treatment cost , better     pregnancy rate, lower multiple pregnancy rates compared with the exclusive use of HP urinary     FSH in these cases.   "
158255|NCT01212250|"     Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled.     After baseline evaluation, the participants will be randomized to receive either Placebo or     Carvedilol 12.5 mg BD. After randomization they will be followed up for one year.   "
158323|NCT01211366|"     Transfusion of washed intra-operative cell salvage post-operatively in the PCICU can be     performed safely without increased risk of bleeding or release of inflammatory mediators.     This will reduce the need for allogeneic blood products as well as crystalloid and colloid     infusions and thus decrease the length of ventilation and intensive care duration for these     infants.   "
158256|NCT01212237|"     Normal tissue response is critical for brain radiotherapy, especially for dose escalation     which carries with it an increased incidence of radiation-induced brain injury. Although     radiation toxicity and limiting dose for anatomically critical structures of the brain have     been well studied and documented, little is known for functionally critical brain regions and     treatment of cognitive sequelae of cranial radiotherapy is limited. The objective of this     clinical protocol is to accumulate preliminary data for future studies aiming to quantify     dose response for functionally critical brain regions for brain radiotherapy. We plan to     achieve this objective by correlating the radiation-induced complications and radiological     changes with the radiation dose to the selected functionally critical brain regions for 25     patients. Each participating patient will receive brain fMRI to identify brain regions for     processing visual, working memory and language functions. The image co-registration algorithm     developed previously by our group will be used to co-register these regions on the CT scans     for radiotherapy treatment planning for radiation dose calculation. Radiation-induced changes     in cognitive functions will be evaluated using the modified mini mental status exam (3MS) and     fMRI during the routine follow-up. The knowledge derived from this study might significantly     improve the quality of life and allow safer dose escalation for patients receiving brain     radiotherapy.   "
158257|NCT01212224|"     This is a confirmation of safety profile for Minirin Melt in clinical practice.   "
158283|NCT01211886|"     Admission BNP was a useful marker for diagnosing and predicting type IV cardio-renal syndrome     type IV in patients with chronic kidney disease admitted to the ICU for acute heart failure     in a retrospective study. Therefore, we aim to prospectively investigate the utility of serum     BNP in evaluating the treatment adequacy and predicting future cardiac events in patients     with type IV CRS.   "
158284|NCT01211873|"     The purpose of this study is to look at the safety (what are the side effects)and efficacy     (how well does it work) of Dotarem® when used in taking images of the brain / spine. The     results will be compared to the results of MRI taken without Dotarem.   "
158258|NCT01212211|"     Mild hyponatremia is the commonest electrolyte imbalance in the older population. Recently,     association between hyponatremia and bone fractures in the ambulatory elderly has been shown.      Mild chronic hyponatremia is causing falls and lead to hospitalisation because of attention     deficit.      Symptoms related to hyponatremia can be very subtle and difficult to detect clinically.     Twenty elderly patients, retirement homes residents, with serum sodium < 135mEq/L will be     included. They will be randomised. The physician will review the drug treatment of ten     patients in coordination with the opinion of pharmacologists. Drug treatment for ten other     patients wil remained unchanged during the three months of inclusion.      Useful elements of the medical records of patients randomized to the experimental arm will be     forwarded to the Pharmacovigilance Regional Center for opinion pharmacologist. The notice,     subject to the attention of physician of retirement homes, give rise to a therapeutic     approach towards the patient. It will be followed by weekly monitoring of serum sodium for 4     weeks to evaluate the impact of the intervention. Thus, the effectiveness of medical     intervention will be evaluated by an objective biological criteria: serum sodium in the     fourth week. Secondary endpoints will evaluate the duration of normalization of serum sodium     and check the interest of correcting hyponatremia to improve postural capacities and     eventually reduce the number of falls in the medium term (three months).   "
158259|NCT01212198|"     This is an observational study done by creating a cohort of Korean patients with diabetes and     those at high risk of developing diabetes. By the creation of this cohort we aim to establish     efficient preventive, diagnostic, and therapeutic measures based on the characteristics of     Korean patients with diabetes, and by doing so, we hope to ultimately decrease our country's     diabetes-related-mortality and increase the quality of life of patients with type 2 diabetes.   "
158260|NCT01212185|"     Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, is effective     in decreasing alcohol withdrawal symptoms, the number of bouts of withdrawal requiring     standard medication treatment (lorazepam) and the amount of lorazepam required to control     withdrawal bouts in individuals undergoing medical detoxification. Also, determine rates of     subject recruitment and retention in the inpatient setting.      Participants: 80 alcohol dependent patients, 18-65 years of age, admitted for medical     detoxification.      Procedures (methods): Subjects will be inpatients undergoing medical detoxification from     alcohol. Oxytocin or placebo will be administered in a nasal spray twice daily in a     randomized, double blind manner for three days. Withdrawal symptoms will be measured     routinely at q4 hours and prn for length of hospital stay. Lorazepam will be given whenever     withdrawal symptoms increase above specific parameters.   "
158261|NCT01212172|"     The purpose of this research study is to compare two different 810 diode laser systems     (Soprano XL (SHR Mode)and Light Sheer Duet) for laser hair removal. The goal is to determine     if each laser system is effective at reducing the amount of hair on the lower legs or the     axilla (arm pit). Another goal is determine the subject's perspective on the treatment     including tolerability and effectiveness.   "
158262|NCT01212159|"     The purpose of the study is to demonstrate that systematic self measurement of blood lipids     reduces LDL cholesterol more effectively than standard care. The hypothesis is that     cholesterol lowering medication adherence will be improved with self monitoring and reporting     of frequent blood lipids and the percentage of patients achieving LDL goal will be greater     than without home monitoring.   "
158263|NCT01212146|"     The aim of the present randomized double-blind controlled crossover study is to compare the     effects of the 15-day consumption of artichokes enriched with the probiotic Lactobacillus     paracasei LMGP22043 with those of ordinary artichokes on treatment preference, satisfactory     relief of symptoms, bowel habit and the modulation of SCFA production in a group of patients     suffering from functional constipation.   "
158264|NCT01212133|"     This study is conducted in Asia. The aim of this study is to evaluate the safety and     effectiveness of liraglutide in subjects with type 2 diabetes mellitus.   "
158265|NCT01212120|"     The presence of S aureus in the nasal passages of diabetic patients may be a risk factor for     diabetic foot lesion infections. Our aim is to compare the genetic profiles of S aureus     strains found in the noses and on the foot lesions of diabetic patients. The investigators     are also studying the virulence of these strains, the prevalance of S aureus at either site,     and whether or not the quantity of S aureus found in the nose affects the risk for infection     in foot lesions. The investigators also use this study to test the sensitivity and     specificity of the GeneXpert system.   "
158266|NCT01212107|"     The study is to determine the recommended Phase 2 regimen of study drug that may be safely     administered to patients with advanced and or metastatic cancer. The study consists of two     parts: a dose escalation and a dose confirmation.   "
158324|NCT01211353|"     The objective of this research is to better understand how to reduce hazardous drinking among     OEF/OIF veterans by assessing the effectiveness of a low-cost, computer-delivered     preventative program.   "
158267|NCT01212094|"     Background:      - Secondary-progressive multiple sclerosis (SP-MS) is the chronic phase of multiple sclerosis     (MS). The majority of people who have relapsing-remitting MS eventually develop SP-MS. There     are currently no effective treatments for SP-MS. Researchers are interested in determining     whether the drug rituximab, which is used to treat rheumatoid arthritis and some types of     cancer, is able to target certain white blood cells that are thought to play a role in the     progression of SP-MS. To ensure that the rituximab will reach the brain and spinal cord,     participants will receive it by intravenous drip and by intrathecal injection (through a     lumbar puncture into the cerebrospinal fluid).      Objectives:      - To evaluate the safety and effectiveness of combined intravenous and intrathecal rituximab     in individuals with secondary-progressive multiple sclerosis.      Eligibility:      - Individuals between 18 and 65 years of age who have been diagnosed with SP-MS and have been     off any form of immunosuppressive therapy for at least 3 months.      Design:      - The study will involve a 1-year pretreatment baseline series of visits, followed by a     2-year treatment period. Participants will provide blood samples throughout treatment as     directed by the study researchers, and additional studies may be performed during the study     period if participants consent to further investigation.   "
158285|NCT01211860|"     Once a day oral administration with DCCR is the optimal dosing regimen   "
158286|NCT01211847|"     Once a day oral administration with DCCR helps lower triglycerides   "
158268|NCT01212081|"     Background:      - Individuals with schizophrenia or schizoaffective disorders have a high prevalence of     cannabis use. Understanding some of the environmental factors that maintain cannabis use,     such as socially triggered cravings, is a critical step in improving treatment for cannabis     dependence. In recent years, virtual reality has been studied to determine whether it can be     used to induce craving by using life-like cue settings. Researchers are interested in using     virtual reality systems to study cannabis cravings in individuals with schizophrenia.      Objectives:      - To determine if virtual reality cues will elicit cannabis craving in persons with     schizophrenia who have a history of cannabis use.      Eligibility:      - Individuals between 18 and 50 years of age who have been diagnosed with schizophrenia or     schizoaffective disorders, are on a stable antipsychotic medication, and who have a lifetime     history of at least 50 cannabis uses and average cannabis use of once per month.      Design:        -  This study involves an initial screening visit, a study visit, and a followup visit.        -  Participants will be screened with a medical history and physical examination, and will          complete questionnaires about their history of marijuana and other drug use.          Participants will also learn how to use the virtual reality equipment at this visit.        -  During the study visit, participants will respond to marijuana cues using the virtual          reality system while researchers monitor their heart rate, blood pressure, and sweat          levels.        -  At the followup visit, participants will complete questionnaires about their mood and          any cravings for marijuana.   "
158269|NCT01212068|"     Background:        -  People with epilepsy often have auditory processing disorders that affect their ability          to hear clearly and may cause problems with understanding speech and other kinds of          verbal communication. Researchers are interested in developing better ways of studying          what parts of the brain are affected by hearing disorders and epilepsy, and they need          better clinical tests to measure how individuals process sound. These tests will allow          researchers to examine and evaluate the effects of epilepsy and related disorders on          speech and communication.        -  A procedure called a magnetoencephalography (MEG) can be used to measure the electrical          currents involved in brain activity. Researchers are interested in learning whether MEG          can be used to detect differences in the processing of simple sounds in patients with          epilepsy, both with and without hearing impairments.      Objectives:      - To measure brain activity in hearing impaired persons with epilepsy and compare the results     with those from people with normal hearing and epilepsy as well as people with normal hearing     and no epilepsy. This research is performed in collaboration with Johns Hopkins Hospital and     epilepsy patients must be candidates for surgery at Johns Hopkins.      Eligibility:        -  Individuals between 18 to 55 years of age who (1) have epilepsy and have hearing          impairments, (2) have epilepsy but do not have hearing impairments, or (3) are healthy          volunteers who have neither epilepsy nor hearing impairments.        -  Participants with epilepsy must have developed seizures after 10 years of age, and must          be candidates for grid implantation surgery at Johns Hopkins Hospital..      Design:        -  This study will require one visit of approximately 4 to 6 hours.        -  Participants will be screened with a full physical examination and medical history,          along with a basic hearing test.        -  Participants will have a magnetic resonance imaging (MRI) scan of the brain, followed by          a MEG scan to record magnetic field changes produced by brain activity.        -  During MEG recording, participants will be asked to listen to various sounds and make          simple responses (pressing a button, moving your hand or speaking) in response to sounds          heard through earphones. The MEG procedure should take between 1 and 2 hours.        -  Treatment at NIH is not provided as part of this protocol.   "
158270|NCT01212055|"     Background:      - Gene therapy is being investigated as a possible treatment for individuals with     immunodeficiency diseases or other conditions that make it difficult to fight off infection.     Gene therapy avoids problems with donor identification and possible rejection of bone marrow     transplant by using the patient s own modified blood cells to help treat the disease.     Researchers are interested in collecting stem cells from the blood of individuals with     immunodeficiency diseases in order to use the cells to develop potential gene therapy     treatments.      Objectives:      - To collect blood stem cells from patients with immunodeficiency diseases tto test our     ability to correct the defects of these cells in the test tube. .      Eligibility:        -  Individuals between 18 and 40 years of age with immunodeficiency diseases.        -  Individuals with human immunodeficiency virus (HIV) will not be able to participate in          this study.      Design:        -  Participants will provide an initial blood sample for disease screening (such as          hepatitis B and C, syphilis, or viruses like the Epstein-Barr virus, herpes simplex          virus, or toxoplasmosis) and to check kidney and liver function.        -  Starting 5 days before blood donation, participants will receive daily injections of a          drug called G-CSF (granulocyte colony stimulating factor, or filgrastim), which pushes          stem cells out of the bone marrow and into the bloodstream. Participants will receive          the injections at the National Institutes of Health Clinical Center.        -  On day 5, participants will have a single leukapheresis procedure to collect the stem          cells from the blood.        -  No additional treatment will be provided as part of this protocol. The cells that are          collected will be used fore experiments in the lab and will not be used to treat          individuals with these diseases.   "
158271|NCT01212042|"     Respiratory infections have a high associated morbidity and mortality, especially in     immunocompromised patients. To initiate effective treatment of respiratory infections, it is     essential that a rapid and thorough laboratory analysis of respiratory specimens be     performed, given the wide range of pulmonary pathogens that can be detected in this     population. Conventional microbiology is time-consuming and cumbersome, and the capability of     local laboratories to assess specimens for rare or unusual pathogens is often limited. This     study will evaluate if a newer technology can be effectively utilized in the identification     of a broader range of infectious agents relative to conventional procedures.      Resequencing Pathogen Microarray (RPM) technology developed by TessArae , LLC which ceased     operations in July 2014) uses a microarray chip to identify multiple pathogens in a clinical     specimen. The technology has had limited clinical application, but early studies have shown     its effectiveness in accurately identifying a large number of viral and bacterial organisms.     In contrast to conventional microbiological procedures based on phenotypic traits (growth     characteristic and enzymatic activity), this is microarray utilizes DNA sequence analysis to     detect and identify the species, serotype/subtype, or strain of the infectious agent.      Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage,     BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be     analyzed using the customized microarray chip. The specimens will be collected as part of the     patients routine clinical care. The results of the TessArray microarray analysis will not be     available to the clinician and therefore will not have any effect on the clinical care of the     patients.      The results of the microarray analysis from each site will be compared to that site s     clinical laboratory results, and the data will be analyzed by site.   "
158439|NCT01209858|"     The purpose of this study is to investigate the effects of perampanel on the pharmacokinetics     (PK) of a single-dose oral contraceptive (OC)containing ethinylestradiol (EE) and     levonorgestrel (LN) (Microgynon-30) and to investigate the effects of repeated dosing of OC     containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.   "
158279|NCT01211938|"     Patients will be randomised after surgery, provided surgery is macroscopically adequate, that     there is a flap of tissue protecting the vascular axis and that wound healing allows     reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two     arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume : tumour     bed + a safety margin of < 2 cm with immediate protection of bone marrow. This volume should     be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy will be     delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in the     investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of reirradiation     and at 6 months from randomization (first follow-up consultation)   "
158280|NCT01211925|"     Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible     peripheral arterial occlusive disease.   "
158281|NCT01211912|"     This study has two aims:        1. to evaluate placental transfer of acetaminophen from mother to baby transplacentally          given from 30 minutes to 24 hours prior to cesarean delivery (34 patients)        2. to understand the impact of maternal acetaminophen use on fetal movement and breathing          (20 patients)   "
158272|NCT01212029|"     Background:      - Non-invasive functional near infrared (fNIR) imaging techniques use infrared light to     detect changes in blood volume and oxygen levels during brain activity. fNIR is being studied     as a possible way to examine the brain activity of individuals who are unable to undergo     standard brain function imaging techniques (such as functional magnetic resonance imaging, or     fMRI). For instance, war veterans who have iron shrapnel in the body are not able to have     fMRI scans, and very young children or children with autism and related disorders are often     not able or willing to cooperate long enough in the MRI environment to allow full imaging     studies to take place. Researchers are interested in comparing the results of fNIR and fMRI     performed on healthy volunteers to determine if fNIR produces similarly accurate results.      Objectives:      - To examine the capabilities of non-invasive functional near infrared imaging techniques on     healthy volunteers and compare the results with the existing outcomes of functional magnetic     resonance imaging.      Eligibility:      - Healthy volunteers at least 18 years of age.      Design:        -  Participants will have one study visit. Depending on the complexity of the task, the          whole exam will take between 5 minutes and 1 hour to perform.        -  Participants will be asked to sit as still as possible while wearing a headband that          includes light sources and detectors (the fNIR device).        -  Participants will be asked to perform a set of tasks (e.g., reading sentences or          counting numbers in one s head). Data will be collected during these experiments.   "
158273|NCT01212016|"     Background:      - Food allergies are characterized by abnormal immune system responses to certain foods, such     as peanuts, strawberries, and shellfish. Some individuals with these allergies have immediate     allergic reactions on contact with the food in question and need immediate treatment to     prevent severe complications. In contrast, eosinophil-associated gastrointestinal disorders     are related disorders in which white blood cells in the intestinal tract react to certain     foods, causing abdominal pain, nausea, and other digestion problems. Researchers are     interested in studying these conditions to better understand how the immune system responds     to food allergies.      Objectives:        -  To examine how the immune system responds to food allergens.        -  To examine how certain white blood cells contribute to disease in individuals with food          allergies and other inflammatory diseases.      Eligibility:        -  Individuals between 18 and 65 years of age who have a history of (a) severe allergic          reaction to peanuts (and have peanut-specific antibodies), (b) allergy or inflammatory          disease, or (c) eosinophil-associated gastrointestinal disorder (with at least two          documented food allergies).        -  Healthy volunteers between 18 and 65 years of age who have no known allergies or asthma.      Design:        -  All participants will have a screening visit and a procedure visit. The procedure visit          will take place within 30 to 60 days of the screening visit, and will take 3 to 4 hours          depending on the procedure(s) done.        -  Participants will be screened with a physical examination and medical history, and will          provide blood samples for testing. Participants with peanut or other allergies will have          additional tests to determine their levels of sensitivity to certain foods. Participants          with eosinophil-associated gastrointestinal disorder will provide stool samples for          testing.        -  At the procedure visit, participants with peanut allergies and participants with other          allergies will provide blood samples and have leukapherisis to collect white blood cells          for examination.        -  At the procedure visit, healthy volunteers and participants with eosinophil-associated          gastrointestinal disorder will provide blood samples and have leukapherisis to collect          white blood cells for examination. In addition, some but not all of these participants          will have a procedure called esophagogastroduodenoscopy (EGD), which will examine the          esophagus, stomach, and small intestine. Participants who are scheduled to have EGD will          be asked to fast for 6 hours before the procedure.   "
158274|NCT01212003|"     Background:      - Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. However,     most clinical studies of individuals with TB take place at international sites because there     are many fewer cases of TB in the United States than elsewhere in the world. To provide     better training for infectious disease staff members at the National Institutes of Health     Clinical Center in Washington, D.C., researchers are interested in actively recruiting     individuals with TB for research and treatment studies.      Objectives:        -  To provide staff at the National Institutes of Health Clinical Center with increased          experience in hands-on treatment of individuals with tuberculosis, including          drug-sensitive or drug-resistant forms of the disease.        -  To collect blood and other samples to study the natural history of tuberculosis.      Eligibility:      - Individuals 2 years of age and older who have either active or latent tuberculosis.      Design:        -  Latent TB patients: Participants will have a single study visit with a physical          examination and medical history, and will provide blood samples for testing.        -  Active TB patients: Participants will have an initial visit with a physical examination          and medical history, and will provide blood samples for testing. Participants will also          provide sputum samples if required, and may have an optional skin punch biopsy to          collect a sample of skin tissue for study.        -  Treatment for active TB will be provided as part of this protocol.        -  Active TB participants will return for study visits every 2 months while receiving          treatment, and will return every 6 months for 1 year after the end of treatment.          Participants may be asked to return more often if researchers determine that additional          care is needed to treat the infection.   "
158275|NCT01211990|"     Background:      - State-of-the art care for children with cancer or rare diseases is not available in all     countries. Owing to the proximity of Latin America and the growing numbers of Latinos already     in the United States, many international patients receiving specialized medical care in U.S.     hospitals are from Spanish-speaking countries. Although there are benefits associated with     obtaining specialized care in the United States, linguistic barriers and cultural differences     as well as the general stresses of caring for a child with a serious illness may affect     families ability to obtain adequate care for their children. Researchers are interested in     exploring the experiences and needs of international Latino families receiving medical care     for their child in the United States in order to help health care centers provide more     appropriate resources and improve the overall quality of culturally sensitive care.      Objectives:      - To understand the experiences of international Latino families who are receiving treatment     for their child or have enrolled their child in a research study in the United States.      Eligibility:        -  Caregivers of a child between birth and 25 years of ages who are from Latin America          (which includes Mexico, all countries in Central America and South America, and          Spanish-speaking Caribbean countries) and who have traveled to the United States to          enroll their child in a research protocol and/or seek treatment for their child s          medical condition.        -  Caregivers must have a child enrolled on a research protocol at the time of this study.        -  Caregivers must have been away from their country of origin for a minimum of 3 months.      Design:        -  This study requires a single interview that should take approximately 1 hour.        -  Participants will complete the interview with a member of the research team who is          bilingual or fluent in Spanish.        -  Participants will be asked open-ended questions about why they chose to come to the          United States, how they are adjusting to living and getting medical care for their child          in the United States, and what hopes they have for treatment outcomes and future medical          care.        -  Researchers will record the interviews to be reviewed later. The recordings will be used          for this study only.   "
158276|NCT01211977|"     Background:        -  Autoinflammatory diseases are illnesses that produce episodes of inflammation such as          fever, rash, or joint swelling. Some of these diseases can be treated with medications          that block the body's reaction to a protein called IL-1, which may be part of the cause          of the inflammation. IL-1 blocking agents are very helpful in treating autoinflammatory          diseases and have become the standard of care for treatment for some of these diseases.          However, more research is needed on related diseases that may be treated with new and          currently used IL-1 blocking agents.        -  XOMA 052 is an experimental drug that is currently being tested as a possible treatment          for type 2 diabetes. Initial studies have shown that XOMA 052 neutralizes a specific          kind of IL-1, and is also active against certain indicators of inflammation. Researchers          are interested in determining whether XOMA 052 can be used to treat autoinflammatory and          related diseases.      Objectives:      - To determine the effectiveness of XOMA 052 as a treatment for inflammation in adults with     the autoinflammatory diseases Familial Cold Autoinflammatory Syndrome (FCAS)/Muckle-Wells     Syndrome (MWS) and Behcet's Disease.      Eligibility:        -  FCAS/ MWS: Individuals at least 18 years of age who have a known history of the typical          disease.        -  Behcet's Disease: Individuals at least 18 years of age who have evidence of active          disease, such as oral or genital ulcers or eye disease.      Design:      FCAS/MWS Participants        -  Participants will have an overnight evaluation of their disease, including optional          tests (e.g., eye or skin exams). Participants who currently take medications to treat          their symptoms will stop taking the medication and will be monitored by study          researchers. At the first flare of symptoms, participants will begin to receive XOMA          052.        -  Participants will have further tests on days 3, 7, and 10 after the initial dose of XOMA          052. If the disease remains under good control, participants will have a clinical exam          every 5 days for up to 10 weeks until another disease flare occurs (determined either by          symptoms or by inflammation observed in laboratory studies). If the disease is not well          controlled with the initial dose of XOMA 052, participants will have additional doses          starting at day 7 until either the disease is controlled or researchers determine that          the medication is not effective.        -  Participants will have the option to continue XOMA 052 treatments for up to 1 year. XOMA          052 wil...   "
158277|NCT01211964|"     The purpose of this phase 1 study is to determine the relative bioavailability and     pharmacokinetics following single oral dose administration of LEO 22811 solution compared to     LEO 22811 tablet in healthy male subjects as well as to determine the effect of food on the     single oral dose pharmacokinetics of LEO 22811 tablet in healthy male subjects.   "
158287|NCT01211834|"     The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in     combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in     patients with moderate to severe active RA and inadequate response to current DMARD treatment   "
158288|NCT01211821|"     The purpose of the study is to assess the effects of BMS-914392 administration on the     pharmacokinetics of a single-dose of metoprolol in healthy subjects.   "
158289|NCT01211808|"     The purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of     single-dose BMS-914392 in healthy subjects.   "
158290|NCT01211795|"     Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been     shown to prevent migraines when used once daily for 3 months in open label studies. This is a     randomized, double-blind, placebo controlled phase III prevention trial to determine safety     and efficacy.   "
158291|NCT01211782|"     The study will evaluate the safety & efficacy of AC-1204, a ketogenic compound, administered     orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study,     subjects may enroll in an optional 6 month open-label extension phase. Efficacy will be     evaluated by standard tests of memory and cognition, along with other measurements of     activities of daily living and quality of life. Safety will be assessed by frequency of     adverse events and changes in laboratory test results. Subjects will be stratified and     outcomes will be separately analyzed based on apolipoprotein E4 genotype (APOE4).   "
158292|NCT01211769|"     Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some     studies have shown that alcohol alters the environment of the membranes, mainly by modifying     their permeability through the lipid fraction. These lipids are known as essential fatty     acids (EFA) because they are obtained only through the diet, as the human body is unable to     synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3,     are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and     metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery.      Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol     dependent patients.   "
158293|NCT01211756|"     The objective of the study is to compare the efficacy of intranasal oxytocin versus     intranasal placebo to improve depression symptoms in patients with Major Depressive Disorder     (MDD) or Dysthymia Disorder.   "
158294|NCT01211743|"     Study of Oxidative Stress Markers in order to assess whether there are differences between     standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated     cholelithiasis   "
158295|NCT01211730|"     Many but not all studies have shown improvement in morbidity and mortality with intensive     glycemic management postoperatively. In this study, the investigators propose to determine     whether improved glycemic control using intensive insulin treatment immediately     postoperatively will improve outcomes in patients undergoing liver transplant using a     prospective, controlled, randomized, parallel-group study design targeting two different     glucose levels, 140 and 180 mg/dL.   "
158296|NCT01211717|"     The purpose of this study is to determine the effectiveness of the 3 Branched Chained Amino     Acids (isoleucine, leucine, and valine) on treating Delayed Onset Muscle Soreness, a type of     muscle pain which usually develops after exercising.   "
158297|NCT01211704|"     The primary specific aim is to examine the efficacy of Paliperidone extended release     Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) compared to placebo in decreasing manic     symptoms in patients with comorbid DSM-IV bipolar disorder and alcohol dependence. The     investigators hypothesize that the Paliperidone Palmitate Injection (INVEGA® SUSTENNA™)     treated group will have a statistically significant advantage on improvement in manic     symptoms. They will also have higher rate of treatment response and remission.   "
158298|NCT01211691|"     This is a global, multicenter, open-label, repeat-dose, Phase 1/2 study consisting of a Dose     Escalation Phase (Phase 1) and a Cohort Expansion Phase (Phase 2). In both phases, KB004 will     be administered by IV infusion once weekly as part of a 21-day dosing cycle.   "
158299|NCT01211678|"     The primary objective of this study was to validate the ability of an 8-gene biomarker set to     differentiate between participants who met or did not meet European League Against Rheumatism     (EULAR) Disease Activity Score (DAS)-28 Good Response criteria after treatment with     anti-Tumor Necrosis Factor (TNF) therapy for 14 weeks in approximately 200 anti-TNF-naïve     participants. The secondary objectives of this study was (i) to compare the behavior of the     8-gene marker set in participants who were anti-TNF naïve versus those who began their second     anti-TNF treatment , (ii) to develop, maintain, and utilize a biorepository of serum, plasma,     RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses and     (iii) to discover novel genetic (DNA) predictors of response to anti-TNF therapy.   "
158300|NCT01211665|"     The objectives of this study are to explore the effects of administering high-dose     corticosteroids to participants who developed progressive multifocal leukoencephalopathy     (PML) while on natalizumab as measured by time-course change in functional status based on     Karnofsky Performance Status Index through 6 months following the completion of plasma     exchange (PLEX; or equivalent), survival at 6 months following the completion of PLEX (or     equivalent), and incidence and severity of adverse events (AEs) and serious adverse events     (SAEs); to characterize the evolution of immune reconstitution inflammatory syndrome (IRIS)     as measured by time course changes in Global Clinical Impression of Improvement (GCI-I),     Symbol Digit Modalities Test (SDMT), brain magnetic resonance imaging (MRI),     magnetoencephalography (MEG), chemokines, cytokines, C-reactive protein (CRP), John     Cunningham virus (JCV) load and cell count in cerebrospinal fluid (CSF); and to characterize     the time course elimination of serum natalizumab concentrations in the study population     following the last PLEX (or equivalent) procedure.   "
158301|NCT01211652|"     The purpose of this study is to assess in general population NSAID and gastroprotective agent     utilization and compliance in elderly people.   "
158327|NCT01211314|"     Treatment and control of hypertension is still insufficient. About 50% of the patients remain     uncontrolled. Lack of compliance with discontinuation of drug treatment is an important     reason for not achieving blood pressure. Several studies have shown that use of fixed     combinations improve compliance significantly, by reducing the number of pill's intake.      This study will assess the antihypertensive efficacy of Vasodip-Combo 20® [enalapril 20 mg +     lercanidipine 10 mg] as a fixed combination drug in uncontrolled antihypertensive patients.   "
158302|NCT01211639|"     The purpose of this study is to explore host genetic mutations which may render individual     subjects more susceptible (or resistant) to developing Progressive Multifocal     Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid     (DNA) sequence of JC Virus (JCV). Analysis of the JC Virus (JCV) genome may provide     information about viral genotypes that may be associated with higher pathogenicity, and help     to identify individuals who may be at higher risk of developing Progressive Multifocal     Leukoencephalopathy (PML) due to chronic infection with a more pathogenic variant of JC Virus     (JCV).   "
158303|NCT01211626|"     The overall study design includes two parts, Part A and Part B.      Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40     evaluable healthy volunteers were enrolled in Part A of the study.      Part B evaluated ANA773 following oral administration to patients with chronic HCV infection.     A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.   "
158304|NCT01211613|"     The investigators will be comparing the effectiveness of two types of chiropractic     manipulation and standard medical care for patients with a recent onset of low back pain. The     two types of chiropractic treatments being compared will be hands-on (manual) manipulation     and mechanical-assisted (Activator) manipulation. The standard medical care will consist of a     medical examination and prescription for over-the-counter anti-inflammatory medication.   "
158305|NCT01211600|"     To determine whether the rate of wound complications differs based on method of closure of     skin incision (staples vs. suture) after cesarean delivery.   "
158306|NCT01211587|"     The purpose of this research trial is to determine if safinamide (experimental drug) can     improve cognition in cognitively impaired but non-demented Parkinson's disease patients. The     word experimental means the trial drug is not approved by Health Authorities (government     authorities) and is still being tested for safety and effectiveness.      Approximately one hundred (100) patients will participate in this research trial. The     research trial will be conducted in approximately thirty (30) medical centers in the     following countries: Argentina, Canada, Italy, Peru, South Africa, Spain and USA. The     research trial will last until June 2012.   "
158307|NCT01211574|"     Participants will be randomly assigned to 1 of 3 types of health coaches, Peers, Mentors, or     Professionals. The aim of this study is to examine the feasibility and preliminary efficacy     of health coaching for weight loss.   "
158308|NCT01211561|"     Selenium's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years,     but has never been directly studied in humans. The investigators will directly assess     selenium's ability to prevent CRC by measuring alterations in aberrant crypt foci (ACF), an     accepted surrogate marker for CRC.      ACF's are very small (i.e., microscopic) collections of abnormally shaped cells that are a     commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that     allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like     polyps or cancers, but can disappear as a person's risk for developing CRC decreases.      The investigators propose giving patient's with 6 or more ACF's 200 mcg selenized yeast or     placebo, and determining if there is a drug-dependant decrease in ACF number. The primary     objective is to determine whether selenized yeast supplementation, compared to placebo,     causes significant reduction of ACF number from baseline levels. The primary endpoint will be     change in ACF number   "
158309|NCT01211548|"     This proposal is for the pilot study that will inform the conduct of a larger prospective     randomized controlled trial to guide perioperative work up and the cost/utility of CTCA (high     definition CT coronary angiography.)   "
158310|NCT01211535|"     The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact     lens wearers.   "
158325|NCT01211340|"     The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this     project is to implement and test this promising intervention in three hospice programs. The     mixed methods evaluation of this randomized controlled trial (RCT) will provide     evidence-based data for a tested intervention manual that hospice staff members can use to     integrate the intervention into their practices.   "
158344|NCT01211093|"     Whole body vibration has been found to be useful in promoting bone health, balance, and     muscle performance in older adults. The overall aim of the proposed study is to determine     whether whole body vibration (WBV) has immediate beneficial effect in neuromotor performance     in patients with stroke. It is hypothesized that a single session of WBV will induce     significant improvement in leg muscle strength in people with chronic stroke.   "
158311|NCT01211522|"     The long-term objective of the MIND-USA (Modifying the Impact of ICU-Induced Neurological     Dysfunction-USA) Study is to define the role of antipsychotics in the management of delirium     in vulnerable critically ill patients. We and others have shown that delirium is an     independent predictor of more death, longer stay, higher cost, and long-term cognitive     impairment often commensurate with moderate dementia. The rapidly expanding aging ICU     population is especially vulnerable to develop delirium, with 7 of 10 medical and surgical     ICU patients developing this organ dysfunction. Antipsychotics are the first-line     pharmacological agents recommended to treat delirium, and over the past 30 years they gained     widespread use in hospitalized patients globally prior to adequate testing of efficacy and     safety for this indication. Haloperidol, the most commonly chosen antipsychotic, is used by     over 80% of ICU doctors for delirium, while atypical antipsychotics are prescribed by 40%.     Antipsychotics safety concerns include lethal cardiac arrhythmias, extrapyramidal symptoms,     and the highly publicized increased mortality associated with their use in non-ICU geriatric     populations. The overarching hypothesis is that administration of typical and atypical     antipsychotics—haloperidol and ziprasidone, in this case—to critically ill patients with     delirium will improve short- and long-term clinical outcomes, including days alive without     acute brain dysfunction (referred to as delirium/coma-free days or DCFDs) over a 14-day     period; 30-day, 90-day, and 1-year survival; ICU length of stay; incidence, severity, and/or     duration of long-term neuropsychological dysfunction; and quality of life at 90-day and     1-year. To test these hypotheses, the MIND-USA Study will be a multi-center, double-blind,     randomized, placebo-controlled investigation in 561 critically ill, delirious     medical/surgical ICU patients who are (a) on mechanical ventilation or non-invasive positive     pressure ventilation or (b) in shock on vasopressors. In each group (haloperidol,     ziprasidone, and placebo), 187 patients will be enrolled and treated until delirium has     resolved for 48 hours or to 14 days (whichever occurs first) and followed for 1 year.   "
158312|NCT01211509|"     Chronic rejection (or Bronchiolitis Obliterans syndrome-BOS) is a major cause of mortality     and morbidity after lung transplantation. Because montelukast has been shown to be of some     efficacy in a similar disease (Obliterative Bronchiolitis after bone marrow transplantation),     the investigators would like to test if montelukast can indeed slow down the progression of     chronic rejection after lung transplantation.   "
158474|NCT01209403|"     The purpose of this study is to investigate whether the anabolic potentials of insulin may be     used to reverse the catabolic effects of hemodialysis in non-diabetic patients with end-stage     renal failure.   "
158313|NCT01211496|"     We are exploring a unique weight-training program for men and women 65 years or older that     emphasizes high speed training. We believe that the speed at which muscles move may be more     important to the performance of functional tasks than how strong the muscles are. We are     comparing velocity training with traditional strength training to determine which method has     the greatest effects on muscle strength, speed of movement, functional performance and     physical disability. We believe that higher speed training will improve these measures to a     greater extent than simply training for increased muscle strength.      Aging also results in loss of bone mass, which increases the risk for falls and fractures.     Strength training also has been shown to maintain bone mass in the elderly, but no studies     have examined high velocity resistance training and maintenance of bone mass. We believe it     is important to examine this aspect of velocity training before recommendations can be made.   "
158314|NCT01211483|"     This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving.     Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding     U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who     fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they     are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287.      The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve     survival in subjects with advanced non-small cell lung cancer who failed the first treatment.   "
158315|NCT01211470|"     The study investigates the safety and efficacy of PMX-30063 in patients treated for acute     bacterial skin and skin-structure infection (ABSSSI).   "
158316|NCT01211457|"     This is an open label, phase I/II study to evaluate the safety and efficacy of sapacitabine     administered in alternating cycles with decitabine in elderly patients with newly diagnosed     Acute Myeloid Leukemia (AML).   "
158317|NCT01211444|"     The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the     Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help     maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).   "
158318|NCT01211431|"     The goal is to compare the quality of post-cesarean analgesia, the side effects and the     incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or     with a continuous intra-wound solution including both ropivacain and diclofenac (experimental     treatment).   "
158319|NCT01211418|"     Cocaine addiction continues to be a major problem in the U.S. with no FDA-approved     pharmaceutical therapy. Finding effective treatment for cocaine addiction has long been a     challenge to scientists and clinicians. Psychosocial interventions known as behavior     therapies are the cornerstone of cocaine addiction treatment. However, there is an urgent     need to further improve treatment outcomes, especially during early recovery and the     protracted withdrawal phase of the treatment since many patients drop out or relapse during     this phase. Our clinical experience and studies suggest that integrative Meditation (IM)     helps reduce cravings and withdrawal symptoms and increases treatment retention. The benefit     of IM is well supported by tension-reduction theory and attention-networks framework in     addiction treatment. The proposed study will implement a therapy development study to add IM     as a self-care component to the current outpatient treatment of cocaine addiction to improve     treatment outcomes.      The specific aims of the proposed study include: 1) to conduct a 12-week controlled trial     with outpatient cocaine users to assess feasibility of recruiting and retaining cocaine     addicts and to determine effect size of IM-augmented treatment in comparison with     Nondirective Therapy (NT) control, with both groups receiving standard outpatient treatment     as usual (TAU), thereby facilitating future larger scale therapy development study; and 2) to     examine the changes in attention networks and negative mood as possible mediators of     treatment outcomes between the two groups.   "
158320|NCT01211405|"     This study is designed to provide information on whether psychotherapy (talk therapy)     combined with the drug MDMA is safe and helpful for subjects with posttraumatic stress     disorder (PTSD). The study will compare the effects of a low, a medium and a full dose of     MDMA on symptoms of PTSD in 24 veterans, firefighters or police officers. MDMA dose will be     assigned at random, and the investigators and the subject will not know the dose given. The     researchers will also investigate depression symptoms. The researchers believe that the full     dose of MDMA will produce a greater reduction in PTSD symptoms than the two lower doses.   "
158321|NCT01211392|"     Prospective study where magnetic resonance imaging is compared to dual-energy computed     tomography for the detection of bone marrow changes.   "
158440|NCT01209845|"     The investigators hope to see if a commonly used drug such as ketamine could help depressed     ER patients feel better and improve their mood quickly.   "
158326|NCT01211327|"     Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, external ocular inflammatory     disease of unknown cause. It is a fairly common disease in hot, dry environments,     representing as much as 3% of severe ophthalmic diseases and up to 33% of all eye pathology     seen among young patients in eye clinics in Central Africa. Symptoms and signs can persist     for years with an important visual morbidity and social impact. Corneal changes (e.g. corneal     ulcers) can be sight threatening, occurring in up to 10% of VKC children. Topical steroid     therapy remains the current standard treatment, but in developing countries its use often is     chronic and not medically supervised, potentially leading to bacterial infections,     steroid-induced glaucoma and cataract. Chromoglycate drops have less side effects but lack     the power to control a flare-up. Topical cyclosporine has the potential to offer an efficient     but safer alternative to steroid drops in the management of VKC in an African setting. Its     safety and efficiency in the management of vernal keratoconjunctivitis have been described in     several uncontrolled studies and double-blind, placebo-controlled trials, but those studies     were relatively small and involved populations outside Africa with predominantly palpebral     and mixed forms of VKC. Controversy still remains on the efficiency of cyclosporine in severe     forms of allergic conjunctivitis like VKC. We therefore undertake a larger prospective     randomized double-masked, standard treatment controlled clinical trial in Central Africa to     compare the short-term efficiency of cyclosporine A (CsA) 2% eye drops, solved in olive oil     vehicle, with that of steroid drops in predominantly limbal forms of VKC. During 4 weeks the     participants will be randomised to either cyclosporine or dexamethasone as attack treatment     for VKC. The 4 weeks thereafter all participants will receive chromoglycate drops as     maintenance treatment. Additional objectives are to document any difference in rebound     phenomenon while on chromoglycate during the maintenance phase between the 2 treatment groups     and to evaluate safety and tolerance of the test medication.   "
158381|NCT01210612|"     Lateral ankle sprain (LAS) is one of the most common injuries in sports. There is a unique     style of socks that have become popular in Japan among athletes that could also improve     postural control. The purpose of the study is to determine the effectiveness of five-toed     socks on dynamic postural control in individuals with and without chronic ankle instability.   "
158328|NCT01211301|"     The purpose of this study is to compare the effectiveness of the Medifast 5 & 1 Plan to a     food-based, reduced-energy diet plan. The study will be conducted over 52 weeks, including a     26-week weight-loss phase and a 26-week weight-maintenance phase. 120 participants will be     enrolled, with 60 randomized to the Medifast 5 & 1 Plan and 60 randomized to food-based,     reduced-energy diet plan. Multiple measures will be performed at baseline, 26 weeks, and 52     weeks, including anthropometry, body composition, blood pressure, blood assays, and appetite     sensations.   "
158329|NCT01211288|"     The purpose is to place implants in HIV positive and HIV negative patients, follow patients     over 3 years period of time, to evaluate how well dental implants perform in HIV-positive     patients versus HIV-negative patients.   "
158330|NCT01211275|"     The purpose of this study is to investigate the effects of axitinib, a potent angiogenesis     inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients     with mesothelioma   "
158331|NCT01211262|"     IMCgp100 is a new biological therapy designed for the treatment of melanoma skin cancer. The     drug is designed to target melanoma cells and stimulate immune cells to kill them. This trial     is designed to establish the level of drug that can be given to a patient that is tolerable.     It also designed to establish the best dosing schedule for the drug and to look for signals     that the drug is working as intended.   "
158332|NCT01211249|"     Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment     with methotrexate will receive once daily two capsules containing either GLPG0259 (25     mg/capsule) or matching placebo, for 12 weeks. In the course of the study the patients will     be examined for severity of disease, as well as for any adverse effects that may occur. If     needed, dosing may be split to one capsule twice daily, or reduced to one capsule of 25 mg.      Part B: If results of Part A suggest test medication to have a therapeutic advantage over     placebo and to be well-tolerated, more patients will be recruited for Part B, where various     dosages will be assessed. These dosages will be established based on results from Part A.   "
158333|NCT01211236|"     The main objective of the trial was to study the efficacy of bagged larvae on wound     debridement in comparison to classical treatments. The secondary outcome was to assess wound     healing, treatment related pain, microbiological modifications, adverse events, comfort of     the dressing and duration of wound care. We performed a randomized, double-blind,     multicenter, controlled, prospective phase III trial in three referral institutional centers     of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a     non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index     (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´     hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged     larvae twice a week) or classical treatments (mechanical debridement and classical dressings     performed three times a week). At discharge, classical dressings were applied and a follow-up     visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin     percentage on wounds treated with MDT and classical treatments at D15. The percentages of     fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems,     British Columbia, Canada), which enables the quantification of color surface variations in a     wound after manual delimitation (using a mouse) on a series of photographic images.   "
158334|NCT01211223|"     • Background: Peridontitis is a group of diseases with complex bacterial etiology that     affects a large proportion of the Chilean and worldwide population. Its treatment, based on     an anti-infective mechanical therapy including scaling and root planning procedures, has been     highly effective in numerous short and long term clinical trials. The use of adjunctive     systemic antibiotics has shown significant improvements in the initial therapy results of     specific periodontal disease types or patient profiles.      The synergic combination of Metronidazole plus amoxicillin has been widely and successfully     used for the treatment of aggressive and severe chronic periodontitis, demonstrating     additional benefits in clinical and microbiological parameters over scaling and root planning     alone. However, and despite its proven efficacy, there is a lack of evidence that evaluates     the impact of antimicrobials intake at different times of the mechanical treatment,     emphasizing the necessity of a study that compares, simultaneously, the variation of the     adjunctive antibiotic effects when they are administered in different moments through the     periodontal therapy course.   "
158412|NCT01210209|"     RATIONALE: Studying samples of blood in the laboratory from patients with cancer and their     relatives may help doctors learn more about changes that occur in DNA and identify biomarkers     related to cancer.      PURPOSE: This research study is looking at blood samples collected from patients with Ewing     sarcoma and their relatives.   "
158335|NCT01211210|"     RATIONALE: Preoperative 5-Fu based chemoradiation has become standard treatment for stage 2/3     rectal cancer. However whether these patients, especially T3N0-1M0 patients, really need     radiation for local control after total mesentery excision being applied in routine practice     is still unknown. And whether new drugs adding in can achieve better local and distant     control is worth investigating.      PURPOSE: This randomized phase II trial is studying 5Fu based radiation therapy or FOLFOX     based radiation or FOLFOX alone, comparing them to see how well they work when given before     surgery in treating patients with intermediate risk resectable rectal cancer. It is not yet     known whether 5-Fu based or FOLFOX based radiation therapy or even FOLFOX alone is more     effective in treating rectal cancer.   "
158336|NCT01211197|"     The objective of the current study is to determine the relative bioavailability of a BI 10773     / metformin fixed dose combination tablet compared to single tablets of BI 10773 and     metformin when administered together and to assess the effect of food on the bioavailability     the fixed dose combination tablet   "
158337|NCT01211184|"     The purpose of this study is to determine whether fluid or glucose administration before hip     replacement surgery minimizes postoperative muscle breakdown (catabolism), fatigue and     disturbances in carbohydrate metabolism.   "
158430|NCT01209975|"     The purpose of this study is to assess retinal blood flow and vascular reactivity in patients     with newly diagnosed primary open angle glaucoma pre- and post-primary Selective Laser     Trabeculoplasty(SLT). Canon Laser Blood Flowmeter will be used for the assessment of retinal     blood flow.   "
158507|NCT01208961|"     The objectives of this study are to compare the relative bioavailabilities of     eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of     Epanova or Lovaza during periods of high- and low -fat consumption.   "
158338|NCT01211171|"     In the light of ONTARGET and TRANSCEND studies results, it would be interesting to     investigate the real-life telmisartan treatment tolerability. It is well known and accepted     that the Real-life setting is much more adequate to reflect the antihypertensive and safety     properties of the drug in comparison to the organized and scheduled setting of the clinical     trial. Because there are not much data on the cough in relation to telmisartan, therefore it     would we worth to observe the cough frequency and general treatment tolerance in patients     treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.   "
158339|NCT01211158|"     When patients come to the Emergency Department with injuries and infections they often need     to have painful procedures performed that are essential to allowing them to recover. To     accomplish this, doctors often use procedural sedation. This involves giving medications     through an intravenous line in order to relieve the patient's pain and to make them drowsy     while the painful procedure is being performed. This allows the medical staff to perform     necessary procedures to patients without causing pain and anguish.      There are several types of medications and combinations of medications that are used for     procedural sedation. Each medication has its advantages and its disadvantages. Consequently,     research is necessary to determine which medication or combination of medications is the most     effective and the safest. This study will compare the use of one drug (Propofol) versus the     use of a combination of Propofol with another drug (Ketamine). Both of these drugs are     already used for procedural sedations in the emergency department but it is not known which     of them is the best or the safest.      The investigators believe that the combination of ketamine and propofol together will work as     good or better than propofol alone and be a safer option as well. Propofol is a well known     sedative that is used in many emergency departments and the clinical experience with it has     been very good because it acts quickly and wears off quickly. However, propofol is not a good     pain-killer and it can also cause patients to stop breathing. This is why monitoring a     patient's breathing and vital signs is essential for any procedural sedation. It is known     that ketamine is a good pain-killer and helps patients to maintain their breathing. Doctors     sometimes use ketamine alone for procedural sedation but patients take a very long time to     wake up when ketamine only is used.      Thus, the investigators think that by combining ketamine with propofol the investigators can     perform painful procedures using procedural sedation without causing patients to stop     breathing as often as with propofol alone. Also, the ketamine the investigators use will help     treat their pain and make them more comfortable.      The investigators plan to enroll 284 patients over the course of about one year. The primary     outcome of adverse respiratory events, as well as the secondary outcomes will be assessed     during the course of the sedation and recovery period, approximately one hour. Quality of     life score and pain will be assessed by telephone interview 3 days after the procedure.   "
158340|NCT01211145|"     The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age     12-17 years) with migraine headaches feel better. This will be done by comparing 3 different     doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).   "
158341|NCT01211132|"     This simple technique of attaching a transparent cap to the tip of the colonoscope has been     evaluated in Japan for improving the detection of polyps and cecal intubation but has not     been formally evaluated in the US and other western countries. In one study (19), the polyp     detection rate was higher with the transparent cap compared to no cap (49% vs. 39%, p=0.04).     Also, the cecal intubation time was shorter with the cap (11.5 min vs 14 min, p=0.008). In a     recently published study, a variation of the cap called the transparent retractable extension     device was used (21). Overall, the number of adenomas detected were significantly higher with     the device compared to without it (205 vs. 150, p=0.04). In an earlier study by Tada et al     (22), use of a transparent cap improved the detection rate of lesions per patient (0.86 vs.     0.58) but did not increase the cecal intubation time. Finally, Lee et al (20) used cap     assisted colonoscopy in patients with difficult colonoscopy procedure (defined as failure to     pass through sigmoid colon after 20 minutes or failure to reach cecum). Using the cap, cecal     intubation was achieved in 94% of patients and this proved to be an effective rescue method     for failed or difficult colonoscopy. The major appeal of this technique is that it is     inexpensive, very practical, and easy to use. Furthermore it is safe and there are no     reported complications from this. If found to be effective in increasing the polyp yield it     has the potential to being incorporated by busy gastroenterologists in their day to day     clinical practice. These features and the preliminary data from Japan merit the evaluation of     this promising technique in the US.   "
158342|NCT01211119|"     Currently, most knee meniscal tears are treated by partial or complete meniscectomy, or by     suture repair when it is possible. Recently, the investigators have successfully developed     and implanted a novel biomaterial, platelet-rich fibrin (PRF), to treat articular cartilage     defect in pigs. The PRF is autogenesis as a natural fibrin-based biomaterial favorable to the     development of microvascularization and enables local and progressive delivery of growth     factors providing unique properties for tissue remodeling and wound healing. The advantages     of using PRF implantation include no transplant rejection and no need to perform second     operation. Knee meniscal repair using PRF has not been reported before. The aim of this study     is to investigate whether PRF implantation can facilitate regeneration process of     meniscectomized knee and T2-map MRI can monitor the process in those patients with meniscal     tears.      A total of 18 adult patients with torn menisci (outer 1/3, posterior horn, medial meniscus)     will be recruited and randomly divided into three groups: A (n=6), implantation of PRF after     partial menisectomy; B (n=6), implantation of PRF after partial menisectomy and suture; C     (n=6), partial menisectomy only. All studied knee will be scanned on a 1.5-T MRI with surface     coil at baseline before surgery, 3 months and 6 months and 12 months after surgery.      The investigators believe that PRF enables to facilitate regeneration of meniscectomized     knee, and T2-map MRI enables monitoring healing process of meniscal tears.   "
158343|NCT01211106|"     The investigators are examining different treatment strategies of helping patients with PTSD     and addiction.   "
158345|NCT01211080|"     Propranolol use for infancy hemangiomas is of world wide interest due to low cost and     presumed efficacy. The investigators hypothesized that the drug ist highly active against     growing hemangiomas in problematic sites and that there are little side effects.      This observational study was undertaken in an uncontrolled fashion to determine sample size,     design and and tools for a later randomized controlled trial on propranolol versus physical     therapy (i.e.cryotherapy) which is the most prevalent treatment for the condition. During     this initial series side effects and relevant design aspects became evident which warrant     expedited reporting.   "
158346|NCT01211067|"     The histology of the internal inguinal ring in patients with indirect hernia submitted to     elective surgery was studied. In contrast with recently published studies, the investigators     believe that histological findings of the internal inguinal ring would reflect those     associated and expected with normal aging.   "
158347|NCT01211054|"     Aim: To evaluate the spirometric data and the prevalence of chronic airway disease in old     population (> 60 yrs) in Korea.      List to do        1. History taking        2. physical examination        3. Routine blood test        4. All spirometric data        5. In subgroup: further evaluation of allergic airway disease   "
158445|NCT01209780|"     This study will evaluate the safety and immunogenicity in healthy children and adolescents     after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.   "
158348|NCT01211041|"     Candida albicans is the most common and important clinical fungal pathogen. Our previous     surveillance disclosed that fluconazole could induce different morphological changes in     clinical strains. Our current study on C. albicans causing candiuria disclosed that renal     insufficiency , diabetes mellitus, respiratory failure and uremia were risk factors of     treatment failure. However, we also found results of E-test drug susceptible test could not     predict outcome. Hence, retrospective analysis of 31 months period, cases that had C.     albicans inducing candidemia were reviewed and 60 cases were enrolled for morphological study     and potential virulent gene analysis.      This study is designed to clarity the clinical meaning of morphological form and virulent     genes on candidemia. To do this study is probably helpful for treatment of candidiasis.   "
158349|NCT01211028|"     The main purpose of this study is to evaluate the safety and feasibility of regenerative     therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in     patients with critical leg ischemia.   "
158350|NCT01211015|"     Aim: To investigate whether ER stress is implicated in the pathogenesis of various pulmonary     disorders      Measurement:        1. Unfolded protein responses (UPRs) in blood (PBMCs)of patients             1. CHOP             2. GRP 78 and so on        2. Unfolded protein responses (UPRs) in blood (PBMCs)of healthy controls             1. CHOP             2. GRP 78 and so on   "
158351|NCT01211002|"     It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with     recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B)     non-small cell lung cancer.   "
158352|NCT01210989|"     Nonalcoholic fatty liver disease is one of the most common chronic liver diseases worldwide.     Nonalcoholic steatohepatitis (NASH) is the active form of the disease which runs a     progressive course and may result in liver cirrhosis and liver cancer. However, there is yet     proven treatment for this disorder. In cell line and animal studies, we have shown that     Phyllanthus urinaria can ameliorate NASH by reducing oxidative stress and lipid accumulation.     Phyllanthus (Hepaguard) has been used widely by patients with chronic liver diseases, but the     efficacy in NASH has not been confirmed in humans.      This study is divided into two parts. In part 1, 60 patients with histology-confirmed NASH     will be randomized to receive Hepaguard or placebo for 24 weeks to test the efficacy.     Endpoints will be assessed at week 24. The aim of part 2 is to test the durability of     Hepaguard. Forty patients originally on Hepaguard will be randomized again to continue     Hepaguard for another 24 weeks or stop the treatment. The endpoints at week 48 will be     further analyzed.   "
158353|NCT01210976|"     Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass     grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to     describe the haemodynamic effects of levosimendan in comparison to placebo in patients     undergoing elective aortic valve replacement (AVR) together with coronary artery bypass     grafting (CABG) surgery. The study is randomized, double-blinded, placebo-controlled and will     be carried out in Heart Center.      Twenty four patients will be randomized into two groups of 12. The treatment group will     receive 24 hour infusion of levosimendan preoperatively where as the placebo group will     receive an identical infusion of thiamine coloured glucose. The splanchnic perfusion will be     measured by the means of vena hepatica cannulation. CircMon B202 (JR Medical Ltd, Tallinn,     Estonia) is used for the measurement of whole-body impedance cardiography derived heart rate,     cardiac index, left cardiac work index, systemic vascular resistance index (SVRI), and     extracellular water (ECW). Surgical procedure, anaesthesia and cardio protection will be     carried out as in standard care. Echo cardiography will be done pre- and postoperatively.     Haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24     hours.   "
158354|NCT01210963|"     Investigation of the occurrence of possible corneal swelling after continuous Intraocular     pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.   "
158355|NCT01210950|"     Limb-length discrepancy can be due to many causes. These are divided into three groups:     congenital (from birth), developmental (from a childhood disease or injury that slows or     damages the growth plates), and posttraumatic (from a fracture that leads to shortening of     the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe     lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift     greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in),     shortening of the long leg can be considered, especially for tall persons. For growing     children, this can be easily accomplished with a small, minimally invasive, uncomplicated     procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone marrow     derived mesenchymal stem cells can shorten the treatment period by acceleration of bone     regeneration during distraction osteogenesis.   "
158356|NCT01210937|"     Carotid endarterectomy has been proven effective in prevention of cerebral vascular events in     patients with severe carotid artery stenosis (symptomatic,>50%;asymptomatic,60%). But during     the surgery, when the carotid artery is clipping, the patient will have the chance to have     hypoperfusion or stroke. Our study is designed to determine how to use TCD to reduce the risk     of death and nonfatal stroke in patients .   "
158357|NCT01210924|"     This is an observational cohort in pediatric HIV patients in China. Children who receive     antiretroviral drugs will be recruited in this study. The main objectives are as follows: 1.     To establish simpler and smarter pediatric antiretroviral therapy in China including both     first-line and second-line regimens. 2. To study the nature, characteristics and mechanisms     of immunoreconstitution in HIV-infected children using the data and samples from the     pediatric antiretroviral therapy cohort. 3. To establish a basic science and clinical     research network based on the pediatric antiretroviral cohort.   "
158427|NCT01210014|"     Recurrent aphthous stomatitis (RAS) is one of the most common of oral mucosa diseases that     affects approximately 20% of the general population. Despite the fact that clinical,     pathologic and therapeutic feature of the disease has been comprehensively studied, the     pathophysiology of aphthous ulcers remains incompletely understood.      Zinc is a potent catalyst of wound healing and zinc deficiency may be a common cause of     delayed tissue repair. Use of zinc sulfate in promotion wound healing and preservation of     epithelial integrity advocated its possible use in the treatment or prevention of recurrent     oral ulcers.      The purpose of the present study was to determine of systemic zinc sulphate in the treatment     of recurrent aphthous stomatitis.   "
158508|NCT01208948|"     To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular     edema.   "
158358|NCT01210911|"     Pancreatic cancer patients have one of the worst prognoses among all cancer types with a 5     year survival rate of less than 5%. Despite significant changes during the last decade in our     molecular knowledge on this disease, the prognosis and management of pancreatic cancer have     remained unchanged. With the advances in molecular biology, newer biologic agents such as     erlotinib, are adding some benefit to the conventional cytotoxic agents. There is a growing     body of literature suggesting that type 2 diabetes mellitus (DM) may be associated with the     development of pancreatic cancer, but this association is complex. Because various DM     medications can affect directly the key factors mediating the association between DM and     pancreatic cancer, understanding the effect of anti-diabetic therapies on pancreatic cancer     is a critical step in fully characterizing the role of type 2 DM in the development of     pancreatic cancer. Indeed, two epidemiologic studies have found that diabetic patients     treated with metformin were less likely to develop cancer, but those treated with insulin     were more likely to die of various kinds cancer. Not only does metformin ameliorate     hyperglycemia and hyperinsulinemia, both of which are associated with the adverse impact of     DM on cancer, metformin also has direct metabolic effects through activation of adenosine     monophosphate-activated protein kinase (AMPK). AMPK regulates many metabolic enzymes and also     inhibits the mammalian target of rapamycin (mTOR) pathway via phosphorylation and     stabilization of the tumor suppressor gene TSC2. But there is an intensive cross-talk between     various pathways. Inhibition of the phosphoinositide 3-kinase (PI3K)/Akt pathway, of which     mTOR is one of the effector proteins, for instance may result in escape via the     mitogen-activated protein kinase (MAPK) pathway and vice verse. Indeed, epidermal growth     factor receptor (EGFR) activation leads to activation of the MAPK pathway and the PI3K     pathway. Thus, since it is clear that blocking one pathway will not always be sufficient to     produce a response in the presence of other activated pathways, the best change of success     will be realized when using a combination of agents that inhibit separate pathways known to     be critical to the survival of the tumour. In line with these observations, combining a small     molecule against the EGFR and inhibition of the PI3K pathway by metformin might account for     potential candidates of the above combinatorial approach. Therefore, in this study, the     investigators want to determine the activity and safety of concurrent interruption of the     MAPK and PI3K pathways by the EGFR tyrosine kinase inhibitor erlotinib and metformin,     combined with gemcitabine in patients with metastatic pancreatic cancer.   "
158359|NCT01210898|"     This study will evaluate the safety and immunogenicity of children previously primed in the     V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.   "
158360|NCT01210885|"     The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity     of two doses of 4 different investigational MenABCWY combination vaccine when administered to     healthy adolescents aged 11-18 years.   "
158361|NCT01210872|"     RATIONALE: Gathering information over time about patients' quality-of-life and satisfaction     with care may help doctors plan the best treatment and help patients live more comfortably.      PURPOSE: This randomized clinical trial is studying quality-of-life assessment in patients     with head and neck cancer treated with radiation therapy.   "
158362|NCT01210859|"     The purpose of this study is to check whether antimuscarinics that usually broadly used in     the treatment of overactive bladder symptoms are effective in the treatment of those symptoms     after insertion of ureteral stents. In order to study the efficacy of the treatment of OAB     symptoms in stented patients the investigator will use a suitable questionnary.   "
158363|NCT01210846|"     The purpose of this study is to obtain QTc data, to assess the effects of tivozanib on ECG     morphology, and to determine the pharmacokinetic pharmacodynamic (PK-PD) relationship between     any observed changes in cardiac repolarization (defined by QTcF duration) and the serum     concentration of tivozanib.   "
158364|NCT01210833|"     HandTutor is a computerized system designed to evaluate and rehabilitate hand function. It is     composed of a glove with optic sensors detecting the movements of the wrist and the fingers     with a biofeedback software designed to evaluate and then to exercise the hand movements     through supplying a variety of computer graphic patterns.      The HandTutor has been used and tested with a stroke population, and it seems potential to be     used with hand injuried population. As a first step, it is important to investigate the     characteristics of the system and how it is matching the hand injuried population.      The purpose if this study is to characterize the HandTuror system and the focused objectives     are:        1. To examine the test-retest reliability of the system when measuring the range of motion          (ROM) of the the fingers among healthy people (control group).        2. To examine the correlation between the ROM measured by the HandTutor and the ROM          measured by conventional assessment tools (goniometer).        3. To examine the ability of the system to distinguish between healthy people and hand          injured people.        4. To examine the correlation between the performance in the HandTutor (in the games part),          and the performance in functional activities.        5. To examine the participants feedback for using the HandTutor (degree of enjoyment).   "
158365|NCT01210820|"     The results of this trial will demonstrate that ISAK performed with the iFS™ femtosecond     laser is a safe procedure.   "
158366|NCT01210807|"     The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens     (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general     postoperative outcomes of the One-Piece Tecnis Multifocal lens.   "
158367|NCT01210794|"     The influence of different food componente on zinc absorption in young adults consuming zinc     fortified porridge's prepared from maize, beans and sorghum: a series of six similar     randomized, single-blind studies.   "
158368|NCT01210781|"     Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's     disease and other indications. A common target for stimulation is the subthalamic nucleus     (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical     improvement.      The project aims to describe the variability of target coordinates in the patient group and     to relate it to clinical outcome as documented in standardized questionaires.        -  Trial with surgical intervention   "
158369|NCT01210768|"     Primary objective:        -  To evaluate the disease-free survival (DFS) in the two randomized arms after therapy          with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer      Secondary objectives:        -  To assess the overall survival (OS)        -  To establish the safety profile by assessing the toxicities and tolerability        -  To assess the quality of life (QoL)        -  To evaluate survival correlation with biomarkers expression.   "
158413|NCT01210196|"     To detect early signs of cardiac and metabolic alterations as well as to evaluate the     progression of cardiac and metabolic impairments in mildly affected patients with Fabry     Disease using high sensitive diagnostic methods.   "
158370|NCT01210755|"     The purpose of this study is to evaluate whether the effect of the two new anticoagulants,     Dabigatran and Rivaroxaban, can be reversed by non-specific and specific inhibitors. For     Dabigatran the investigators will test the non-specific inhibitors: prothrombin complex     concentrate (PCC), recombinant activated coagulation factor VII, and activated     prothrombin-complex (FEIBA). For Rivaroxaban the investigators will test a specific     Rivaroxaban decoy (FXa-GLAless). This will be done in a laboratory using blood plasma from     healthy male volunteers.   "
158371|NCT01210742|"     Treatment for early osteoarthritis (OA) of the knee is an increasing problem yet much of the     research into OA, to date, concentrates on predisposition, genetic and cellular aspects and     the treatment of late stage disease (arthroplasty). Clinicians reviewing patients with early     OA have great difficulty in recommending an appropriate and efficacious intervention.      The first line of treatment for patients with early OA is exercise, self-management and     weight loss. These tools are suggested to minimize the need for higher risk treatments such     as non-steroidal antiinflammatory drugs (NSAIDs) and surgery. Viscosupplementation using     intra-articular injections of hyaluronan (Synvisc One) is a relatively new treatment. To     date, the ideal patient for viscosupplementation has yet to be defined. It is not known     whether incorporation of viscosupplementation into the overall clinical management will have     beneficial influence for patients with early OA of the knee.      This study will generate rigorous pilot data to assess the need and inform a larger     randomized controlled trial (RCT) assessing the efficacy of viscosupplementation. The study     will be a single blind randomised RCT. 60 patients with documented early OA will be     randomised into one of two groups; Group V will undergo one shot viscosupplementation using     Synvisc One in addition to routine physiotherapy management for knee OA. Group No V (control)     will have no viscosupplementation but will undergo similar routine management including     physiotherapy management for knee OA. Outcome measures will include walking pain (The Western     Ontario and McMaster Universities Arthritis Index-WOMAC), the overall WOMAC score, Oxford     Knee Score (OKS), American Knee Society score (AKS), complications, activity level and     patient satisfaction. Health economics will also be evaluated. Measurements will be recorded     pre-intervention and at six months following treatment.      The risks associated with viscosupplementation are minimal. Considering the limited resources     currently available in health care, if the latter is shown to have higher effectiveness than     physiotherapy alone, in addition to patient benefit, there will be important health economic     implications.   "
158372|NCT01210729|"     The objective of this study is to collect data on the use of the SOLITAIR FR device for     treatment of acute ischemic stroke with large artery occlusion i.e. to investigate, whether     the application of SOLITAIR is a safe and feasible method for interventional recanalization     of large vessels with favorable patient outcome in acute stroke therapy.   "
158373|NCT01210716|"     This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma     Exchange (TPE) is prescribed by their physicians.   "
158374|NCT01210703|"     Acoustic Pharyngometry (AP) is a method of measurement of Transversal Sectional Areas (TSA)     and Volumes of oral cavity and pharynx, based on acoustic waves. The aim of this study is to     describe changes on oropharynx dimensions caused by CPAP (Continuous Positive Air Pressure)     in patients with severe Obstructive Sleep Apnea Syndrome when compared with patients with     Primary Snore, using AP. The exam will be made during the use of CPAP, at various pressures.     The investigators also intend to determine if pressure determined by Polysomnography in OSAS     patients cause some type of different change in AP graphic.   "
158375|NCT01210690|"     The purpose of this observational study is to broaden the knowledge of the known safety and     efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than     12 months when treated according to routine clinical practice. Their data will be collected     until they reach the age of 13 months.   "
158376|NCT01210677|"     There are no published clinical consensus guidelines on the treatment of cardiac sarcoidosis.     Corticosteroid therapy is advocated by some experts, but is based on small observational     studies, with varied clinical response.      Objectives of this trial:        -  to systemically assess the response of patients with cardiac sarcoidosis, to treatment          with corticosteroids        -  to identify the clinical predictors of response to treatment with corticosteroids        -  to assess the utility of imaging with PET and MRI to predict response to treatment with          corticosteroids        -  to determine the prevalence of cardiac sarcoidosis in young patients with unexplained          heart block and in patients with unexplained dilated cardiomyopathy associated with          ventricular tachycardia        -  to use the data from this pilot study to assess the need, feasibility, and sample size          for a larger multicentre trial   "
158377|NCT01210664|"     The investigational therapy under study in this trial, regulatory T cells (Tregs), offers the     hope of stabilizing further destruction of insulin producing beta cells in type 1 diabetes.     Tregs are a specialized subset of T cells that function to control the immune response.     Pre-clinical studies in non-obese diabetic mice have demonstrated that adoptive transfer of     Tregs can slow diabetes progression and, in some cases, reverse new onset diabetes. The     primary purpose of this Phase 1 study is to assess the safety and feasibility of intravenous     infusion of ex vivo selected and expanded autologous polyclonal Tregs in patients with type 1     diabetes (T1DM) to support dose selection for a future efficacy trial. The study also aims to     assess the effect of Tregs on beta cell function as well as on other measures of diabetes     severity and the autoimmune response underlying T1DM.   "
158378|NCT01210651|"     This was a randomized controlled pilot trial to evaluate clinical efficacy and feasibility of     hatha yoga as a mono-therapy for major depression. Investigators recruited 38 adults in San     Francisco meeting criteria for major depression of mild-to-moderate severity, per structured     psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI). At     screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy,     herbal/nutraceutical mood therapies, or mind-body practices were excluded. Twenty     participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8     weeks. Eighteen participants were randomized to 90-minute attention control education groups     twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a     university clinic. Primary outcome was depression severity, measured by BDI scores every 2     weeks from intervention start at 0 weeks until finish at 8 weeks. Secondary outcomes were     self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES)     and Rosenberg Self-Esteem Scale (RSES) at 0 weeks and 8 weeks. Blinded assessors analyzed     whether change in outcome measures would be statistically comparable between the two     intervention groups.   "
158379|NCT01210638|"     The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10     mg Tablets under fasting conditions   "
158414|NCT01210183|"     Dextrose injection in end-stage knee arthritis will cause growth of cartilage cells in a     particular area of complete cartilage loss. Dextrose concentration will be 12.5%. Cartilage     status will be monitored by pre and post treatment arthroscopy views with specialized     (methylene blue) staining for cartilage.   "
158380|NCT01210625|"     The investigators hypothesize that daily oral intake of starch-entrapped alginate     microspheres (called Nutrabiotix fiber) is well tolerated, exhibits no or minimal typical     side effects of fiber (e.g. bloating, loose stool, flatulence), can be used as an ideal     vehicle to deliver anti-oxidants/anti-inflammatory natural and synthetic substances/agents;     and promote gut health by improving bowel habit, by changing the gut microbiota and     increasing production of short chain fatty acids, especially butyrate, in the colon and     decreasing production of protein putrification (prebiotic effects).   "
158382|NCT01210599|"     INTRODUCTION Pamidronate and other bisphosphonates (bisph) have an anti-nociceptive effect in     animals. In humans, IV pamidronate is analgesic in patients affected by numerous painful     conditions, including cancer bone pain, complex regional pain syndrome (CRPS), ankylosing     spondylitis, and rheumatoid arthritis. The investigators have explored the effect of IV     pamidronate in the management of chronic low back pain (CLBP), a worldwide public health     problem in terms of lost workdays, treatment costs, and suffering.      The study was a randomized, double blind, dose-escalation trial of IV pamidronate. Study     participants were divided among four study phases. Each group received IV placebo or     escalating doses of IV pamidronate.      STUDY DESIGN A phase I-II, randomized, double-blind, placebo controlled, dose finding study     for the treatment of patients with CLBP with IV pamidronate. The study was first conducted at     Beth Israel Medical Center, NY for the first two groups, and was completed at Mount Sinai     Medical Center , NY for the remaining groups.      PRIMARY OBJECTIVES The intent of this pilot study was to determine the optimal IV pamidronate     treatment protocol for CLBP in a Phase III trial. Primary study aims were safety and average     daily pain. Subjects used an electronic diary (LOGPAD) to record their daily adverse events     (AEs) and their baseline and post-treatment average pain on the 0-10 numerical rating scale     (NRS).      STATISTICAL ANALYSES All the analysis were performed on an intention-to-treat basis. Primary     outcomes are LOGPAD change in pain severity and whether a patient was a responder (pain score     dropped ≥2 points or ≥30%). Because there was no statistical difference in these two outcomes     among the 4 placebo groups, all placebo patients were combined (Comb PL) in the subsequent     analyses. Primary analytic tool was mixed model for repeated measures (MMRM), assuming     autoregressive covariance structure (LOGPAD pain and Brief Pain Inventory - BPI     interferences), and Generalized Estimating Equation (GEE) model for categorical outcomes     (Response rates and Patient Global Impression of Change - PGIC). The main objective was to     assess whether the changes in outcome from baseline or the response rates were the same     across the study phases, while adjusting for baseline values and time effect. Least square     means were contrasted. Interaction between time and study phases were also tested to see if     the treatment effect is a function of time. Fisher's exact tests or ANOVA (Kruskal-Wallis)     tests were performed for cross-sectional group comparison, including baseline.   "
158383|NCT01210586|"     This study investigated whether being on transdermal hormone replacement therapy (HRT)     influenced smoking cessation variables in postmenopausal women undergoing short-term     abstinence from cigarettes. Women were recruited into two groups according to their     pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT     group had their prior medication replaced with a standard 0.1 mg estradiol transdermal system     and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment, participants     continued smoking as usual for one week, at which time baseline measurements were taken. For     the remaining two weeks, participants were instructed to quit smoking. They were provided     with smoking cessation counseling and monitored for abstinence. Data were collected during     five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal Scale, Beck     Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and Reaction     Time Test.      Part II is identical to Part I, except it randomizes participants to use nicotine patch or     not.   "
158384|NCT01210573|"     To observe and document ventilation parameters in the advanced heart failure population,     through the course of illness, which often includes cardiac resynchronization therapy (CRT),     left ventricular assist device (LVAD), and transplant. Findings from this cohort are     anticipated to be of sufficient interest to the scientific community to merit publication and     are likely to provide preliminary data for future hypothesis generation and subsequent     prospective, randomized controlled trials.      A compact, inexpensive apparatus has recently become commercially available for performing     sub-maximal exercise testing (SHAPE Medical, St Paul, MN), including gas exchange analysis     and will be used in this study. This apparatus is not investigational.   "
158385|NCT01210560|"     To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of     tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals     of this trial are two-fold:        1. To directly compare the immediate release (IR) and MR formulations        2. To determine the dose range and dose regimen for MR (dose finding)   "
158386|NCT01210547|"     The goal of this project is to reduce the radiation exposure in orthodontic patients by the     use of a new imaging protocols based on non-ionizing orthodontic records (e.g. digital dental     models, three-dimensional photograph) The first step in this process is to develop and     validate an orthodontic analysis able to assess craniofacial proportions, dental, skeletal,     and facial soft tissue. The investigators working hypothesis is that data from     three-dimensional facial photographs and from digital dental casts can be registered     accurately and consistently, and the diagnostic information about tooth position and facial     soft-tissue derived from them are comparable to x-ray derived data   "
158387|NCT01210534|"     Enrollment of candidates undergoing a deep brain stimulator (DBS) implant.   "
158388|NCT01210521|"     The purpose of this study is to determine the effects of vitamin D3 on severe asthmatic     patients. Vitamin D3 may alter the response of these patients to conventional steroid     therapy, making them more responsive to the latter form of treatment. Patients will be     treated daily with an oral dose (2,000 IU) of vitamin D3 for one month and their clinical and     serological parameters, and immune function, will be evaluated. Results from pre- and     post-vitaminD3 treatment will be compared.   "
158426|NCT01210027|"     Researchers at the the University of Michigan are conducting a research project to assess how     a course of radiation therapy changes the way blood flows through the liver. To be able to do     this, the researchers will be using MRI (magnetic resonance imaging) scans completed before,     during, and after radiation therapy. MRI's will be done on 4 or 5 occasions. On each     occasion, you will be injected with a fluid called gadolinium (a contrast agent) before     getting an MRI. This contrast agent makes it easier for the Researchers to see your organs in     the scans, and causes any abnormal areas to become very bright on the MRI. This agent will be     injected into a vein in your arm or leg. Each MRI scan will last approximately 45 minutes.   "
184899|NCT00256919|"     This study is designed to compare a range of doses of GW856553 versus placebo on the     biomarkers associated with rheumatoid arthritis   "
158428|NCT01210001|"     This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients     in order to provide these data for approval for BI 10773 by regulatory authorities as an     antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.   "
158429|NCT01209988|"     To date, there is a lack of consensus concerning the optimal timing for removal of the     urethral catheter, its related complications, the effectiveness in prophylactic drug use to     reduce complication, and the patient reported outcomes (quality of life) after robot-assisted     laparoscopic prostatectomy (RALP). The purpose of this study is to determine the impact of     tamsulosin on voiding patterns following early urethral catheter removal after RALP for     prostate cancer.   "
158550|NCT01208389|"     The study is a follow-on to a Phase 1 dose-escalation and safety study.   "
158389|NCT01210508|"     70% of all cancer patients develop some form of visceral (internal organs) or skeletal     metastases (spread of disease). Approximately one third of cancer patients develop metastases     to the spinal column. The prognosis once spinal metastases have been diagnosed and the most     appropriate treatment still remains controversial. To date there is no one good diagnostic     tool to predict survival and/or outcome after radiotherapy or surgical intervention.      Tokuhashi, et al, formulated and presented a preoperative scoring system to evaluate     indications for surgery and predict outcome in patients with metastases to the spinal column.     Six variables are measured to calculate this score: general medical condition, number of     extraspinal metastases, number of vertebral metastases, status of metastases to the major     internal organs, primary tumor type, and presence of a neurologic deficit. This scoring     system has been gaining acceptance in literature. In 1998, Tokuhashi, et al, modified this     scoring system by diversifying the tumor types into six categories. After a retrospective     analysis Tokuhashi reported that patients with scores less than or equal to 8 will die of     their disease within 6 months and those with scores of 12 or greater will survive an average     of 12 months or more.      The purpose of this study is to determine 1) the Tokuhashi score's validity in predicting     survival after developing spinal metastases, 2) the relationship of treatment on survival     after detecting spinal metastases in relation to the Tokuhashi score. Patients will be     enrolled into the study and followed prospectively for as long as possible regardless of     intervention.      There will be three groups based on their Tokuhashi score, each group will require     approximately 163 subjects statistically.   "
158390|NCT01210495|"     The study is designed to demonstrate that axitinib plus best supportive care is superior to     placebo plus best supportive care in prolonging survival in patients with advanced     hepatocellular carcinoma.   "
158391|NCT01210482|"     The objective of this investigation is to determine the following items in all patients     receiving Torisel for a certain period after marketing:        1. Confirmation of efficacy and safety for medical practice use.        2. Investigation of factors that may influence the incidence of adverse events          (Particularly priority investigation items).        3. Investigation of the incidence status and the risk factors for interstitial lung          diseases.   "
158392|NCT01210469|"     The purpose of this study was compare the efficacy of two exercise programs - the first     consisting of balance training and muscle strength and the second consisting of balance     training and muscle stretching exercises - to improve postural control in elderly women with     osteoporosis.   "
158393|NCT01210456|"     Contrast-Induced Acute Kidney Injury(CIAKI) was defined as an absolute increase in serum     creatinine of more than or equal to 0.3mg/dl (≥ 26.4 μmol/l), a percentage increase in serum     creatinine of more than or equal to 50% (1.5-fold from baseline) within 48 hours of     intravascular contrast administration in the absence of any alternative causes, or a     reduction in urine output documented oliguria of less than 0.5 ml/kg per hour for more than     six hours.      It is the common cause of new hospital-acquired renal insufficiency. The occurrence of CIAKI     may be influenced by pre-existing renal insufficiency, diabetic nephropathy, dehydration,     congestive heart failure, concurrent administration of nephrotoxic drugs, or the dose and     type of contrast media used. Previous studies have shown the independent effectiveness of     several agents in preventing CIAKI.      Even now, hydration is crucial for preventing CIAKI. Since CIAKI is presumed to be caused by     free radical generation, N-Acetylcysteine, which is a potent free radical scavenger, is shown     to be effective in preventing nephropathy. At the same time, because free radical formation     is promoted by an acidic environment, bicarbonate, which alkalinizes renal tubular fluid, has     been shown to reduce renal involvement.      These days, some studies have shown that hydration with sodium bicarbonate plus     N-Acetylcysteine was effective and safe in the prevention of CIAKI. In these studies,     bicarbonate was used for both alkalinizing renal tubular fluid and hydration. However, if we     want to do hydration, we can use saline and if we want to alkalinize renal tubular fluid, we     might use bicarbonate by bolus injection.      Actually, bicarbonate for hydration is prepared at sterile preparation room in a hospital,     which is very cumbersome procedure and increase in cost. This is one of the reasons that     bicarbonate for hydration use does not become common with wide clinical application.      In past issues, though it differs depending on the level of the renal dysfunction, the     probability of CIAKI was 8-33% when hydration was administered, 5-15% when hydration and     N-Acetylcysteine were administered, and 1.8-1.9% when bicarbonate and N-Acetylcysteine were     administered.      Thus, we can hypothesize the combination of N-Acetylcysteine and bicarbonate will play a     complementary role in preventing contrast-induced nephropathy.      This is the rational for this study.   "
158394|NCT01210443|"     The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were     demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU,     Canada and Australia. In this study, the long-term safety and efficacy after administrations     of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will     be investigated in Japanese PAH patients.   "
158395|NCT01210430|"     The investigators study will determine how often blood flow regulation abnormalities and     abnormalities of sympathetic regulation produced by nitric oxide, angiotensin-II, and     oxidative stress occur in POTS and the mechanism(s) of POTS in individual patients. Specific     causes for POTS may vary from patient to patient. Patients will be compared to healthy     control subjects. There is a treatment arm with a medication (losartan) that reduces the     binding of angiotensin and increases NO. If the investigators know the specific biochemical     mechanism the investigators may be able to offer further specific treatments to specific     patients.   "
158396|NCT01210417|"     In the prehospital setting it would be helpful to assess primary changes in central blood     volume or preload (venous return, stroke volume, diastolic ventricular volume) that occur     during the stability phase following injury when regulatory mechanisms are still functioning.      Obviously in this setting a non invasive bedside beat-to-beat index would be helpful.      Pulse Transit Time (PTT) is the sum of Pre-Ejection Period (PEP), the time interval between     the onset of ventricular depolarization and the ventricular ejection, and Vascular Transit     Time (VTT), the time it takes for the pulse wave to travel from the aortic valve to the     peripheral arteries (Obrist et al. 1979). PEP variations are known to correlate with     reductions in central blood volume induced by head-up tilt (Chan et al., 2007b, 2008). The     same authors also demonstrated that PTT variations follow closely PEP variations and     therefore central blood volume variations (Chan et al., 2007b). Following central blood     volume reductions induced by head-up tilting ventricular diastolic filling time increases     involving an increase in PEP and PTT. Chan et al. (Chan et al., 2007b) concluded that PTT     could have been used to assess early central hypovolemia and suggested that joint analysis of     PTT and RR intervals could help in predicting the extent of blood volume loss. The     investigators hypothesized that sympathetic drive associated with trauma would act on cardiac     contractility through beta activity thus shortening PTT without reducing RR interval to the     same extent in healthy hearts. We also hypothesized that progressive hypovolemia would lead     to a rising of PTT (augmented diastolic filling time) and a RR interval shortening (relative     tachycardia). In this study the investigators propose and index based on the beat-to-beat     PTT/RR ratio to assess central hypovolemia in traumatic patients enrolled by our Helicopter     Emergency Medical System (HEMS) in a prehospital setting.   "
158397|NCT01210404|"     Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C     infection. Given the likelihood of co administration of filibuvir and methadone, this study     will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.   "
158398|NCT01210391|"     The primary objective of the clinical trial is to compare growth in infants (expressed as     weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants     consuming a commercially available EHF.   "
158399|NCT01210378|"     Nitroglycerin is a nitric oxide donor which is mainly known as a vasodilating agent used in     ischemic heart disease. It has also been shown to increase tumor blood flow in animal and     human tumors.      The addition of nitroglycerin to chemotherapy in non small cell lung cancer has been shown to     generate very favorable response rates with respect to standard treatment schedules[5].     Theoretically nitroglycerin might reduce resistance to chemotherapy via a plethora of     different effects: better tumor perfusion, direct effects of NO on cancer cells, increase in     activated p53 protein and via an increased blood flow in the tumour with as consequence a     higher drug concentration in the tumor [6] .      In mice, nitric oxide donors such as isosorbide dinitrate have been shown to decrease tumor     hypoxia by better tumor perfusion, which could enhance radiotherapy responses [7].      To date these combined effects have not been tested in humans. In this trial we would like to     demonstrate the effect of nitroglycerin on tumor perfusion and hypoxia in non small cell lung     cancer (using DCE and HX4 scanning), providing a rationale for further study and to test the     effect of combining nitroglycerine to standard treatment of NSCLC     (radiotherapy/chemotherapy).   "
158400|NCT01210365|"     The study consists in two treatment groups, one group will receive Diurisa® (furosemide 40 mg     + amiloride chloride 10 mg) and the other one will receive furosemide 40 mg (Lasix®)   "
158401|NCT01210352|"     The purpose of this study is to evaluate the effectiveness, tolerability, and safety of     oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain     in pediatric subjects.   "
158402|NCT01210339|"     The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic     Acid (ASA) 81 mg affect the metabolism of clopidogrel.   "
158403|NCT01210326|"     Azoospermia , as the name suggests , refers to the condition in which there are no sperm in     the semen. This diagnosis can come as a rude shock, because most men with a zero sperm count     have normal libido; normal sexual function; and their semen looks completely normal too. The     diagnosis can only be made by examining the semen under a microscope in the laboratory.Men     with non-obstructive azoospermia have a normal passageway, but abnormal testicular function,     and their testes do not produce sperm normally. Some of these men may have small testes on     clinical examination. The testicular failure may be partial, which means that only a few     areas of the testes produce sperm, but this sperm production is not enough for it to be     ejaculated. Other men may have complete testicular failure, which means there is no sperm     production at all in the entire testes. The only way to differentiate between complete and     partial testicular failure is by doing multiple testicular micro-biopsies to sample different     areas of the testes and send them for pathological examination. This technique is called     TESA, or testicular sperm aspiration ( also known as TESE, or testicular sperm extraction) or     mTESE ( micro-testicular sperm extraction).   "
158404|NCT01210313|"     -  feasibility of physical activity        -  increase of physical conversation        -  Quality of Life (optional)        -  vascular and metabolic effects   "
158405|NCT01210300|"     The incidence of caesarean section (CS) has increased globally. Taiwan's statistics report a     higher incidence of repeat CS compared to vaginal birth after caesarean (VBAC). This is     concerning, as repeat CS are associated with increased maternal morbidity and mortality, and     neonatal respiratory problems. VBAC is an approach which reduces the likelihood of such birth     complications. However, there is limited information about Taiwanese women's decision     regarding VBAC and their participation in decision-making. There is also a gap in literature     about information for women about CS and VBAC.   "
158406|NCT01210287|"     The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in     Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis     B undergoing RCHOP immuno-chemotherapy.   "
158407|NCT01210274|"     Myelodysplastic syndromes (MDS) are frequent diseases in elderly patients (median age: 71     years). IPSS classification defines low risk (Low and Intermediate 1), and high risk     (Intermediate 2 and High) MDS. High-risk MDS (MDS-HR) have a high risk of transformation into     acute leukemia with multilineage dysplasia (AML-DML). The success of Azacitidine has been     mainly achieved through a rigorous empirical and clinical research, but the molecular     mechanisms by which this molecule exerts its effects remain poorly characterized. The primary     mode of action of Azacytidine is through DNA demethylation, and integration in to mRNA that     favor traduction inhibition. The impact of this molecule on various cell death programs     involved in the elimination of leukemic cells : apoptosis and autophagy is currently poorly     known.      The research program and clinical studies we proposed focus on two major aspects:      - Main objective: Molecular mechanism of action and resistance to Azacitidine: Role of     apoptosis versus autophagy.      - Secondary Objective: Reversion of Azacytidine resistance using different drugs targeting     apoptosis and/or autophagy. Our laboratory has identified new molecules to selectively induce     different types of cell death (apoptosis or autophagy).   "
158408|NCT01210261|"     Obstructive sleep apnea (OSA) is a condition of disordered breathing characterised by     intermittent partial and/or complete upper airway obstruction during sleep. The participants,     naive to nasal continuous positive airway pressure (CPAP), recently diagnosed with OSA, will     undergo two automatic CPAP titration studies with collection of polysomnographic (PSG) data.     The data will be analysed to assess effectiveness of Compumedics auto-CPAP device in the     normalisation of sleep disordered breathing in OSA patients, with respect to another     auto-CPAP device.   "
158409|NCT01210248|"     The aim of this study is to check correlation between CYP2C19 genotype level of clopidogrel     metabolite in plasma and platelet inhibition status.   "
158410|NCT01210235|"     The investigators overall goal is to develop, implement, test, and disseminate an     intervention to increase colorectal cancer screening rates at Kaiser Permanente (KP) by     providing home fecal immunochemical test kits (FIT) to eligible patients aged 50 and older     who participate in annual influenza vaccination campaigns. The investigators hypothesis is     that the FLU-FIT Program will be an effective method to increase colorectal cancer screening     rates at Kaiser Permanente.   "
158411|NCT01210222|"     This phase II trial studies the side effects and how well trebananib works in treating     patients with persistent or recurrent endometrial cancer. Trebananib may stop the growth of     endometrial cancer by blocking blood flow to the tumor.   "
173852|NCT00117078|"     The purpose of this study was to evaluate subject preference for Aranesp® administered once     monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).   "
158415|NCT01210170|"     Glucocorticosteroids inhibit the disposal of organic cations by blocking organic cation     transporters expressed by non-neuronal cells, thereby interfering with the inactivation of     the organic cations by intracellular enzymes. Beta2-adrenergic agonists are organic cations,     and the concentration of inhaled beta2-adrenergic agonists at beta2-adrenergic receptor sites     on smooth muscle is likely to be increased by inhaled glucocorticosteroids (ICS) by the ICS'     effect on the glucocorticosteroid-sensitive organic cation transporters. The investigators     have shown in human airway vascular smooth muscle cells that the glucocorticosteroid action     on organic cation uptake occurs within minutes, does not involve gene transcription or     protein synthesis, is not mediated through classical steroid receptors, and is cell     membrane-linked.      In the present proposal, the investigators wish to use different single doses of mometasone,     a clinically effective ICS, administered with or at different times before albuterol     inhalation in subjects with moderate persistent asthma who are obstructed at the time of     study.      With this approach the investigators will test the hypothesis that a single inhalation of     mometasone causes an acute, transient, dose-dependent potentiation of beta2-adrenergic     bronchodilation.      If the hypothesis that a single dose of mometasone acutely potentiates beta2-adrenergic     bronchodilation is correct, the results would have a significant impact on treatment     strategies involving ICSs and beta2-adrenergic agonists in patients with asthma.   "
158416|NCT01210157|"     The purpose of this study is to determine whether galectin-3 binding protein plasma levels     can predict adverse cardiovascular events in patients with coronary artery disease and/or     heart failure.   "
158417|NCT01210144|"     This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the     gene expression profiles and histologic changes of the endometrial tissue before and after     stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic     markers in assisted reproductive technologies (ART) in addition to the clinical predictive     factors already known. Among those predictive factors, the state of the endometrium is     considered as an important implantation determining factor for which pharmacogenomic research     is of great interest.      The direct benefits of this study will be to know whether the endometrial gene expression     profile is modified in response to stimulation treatment and have an impact or not on the     endometrial tissue receptivity. The potential benefits of this study could be to assess the     therapy optimization based on individual treatment response and gene expression profile     compared to group treatment response in infertile women and prediction of response to therapy     based on gene expression profiling before and after Gonal-f® stimulation in infertile women.   "
158418|NCT01210131|"     Since radiation dose escalation to a large volume of tumour inevitably will induce higher     toxicity than is currently the case, efforts must be made to limit the volume of tissue     irradiated. Moreover, the irradiation of larger tumour volumes leads to a lower achievable     tumour dose when keeping the normal tissue doses constant. Central is thus the question     whether it would be possible to limit the volume of tumour to be boosted by selectively     escalating the radiation dose to specific disease sites which are theoretically more prone to     relapse.   "
158419|NCT01210118|"     The aim of this clinical trial is to test whether offering pregnant smokers a high intensity     intervention for smoking cessation increases the rate of smoking cessation at the third     trimester of pregnancy, compared to low intensity intervention for smoking cessation that is     the usual care, control condition.   "
158420|NCT01210105|"     To determine whether video laryngioscopes facilitate intubation in ice-pick position in a     manikin with restricted access to the airway   "
158421|NCT01210092|"     To determine whether different video laryngoscopes facilitate intubation in an manikin with     immobilized cervical spine compared with standard laryngoscopy.   "
158422|NCT01210079|"     Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the     ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced     hyperalgesia complicating the pain states suffered by Methadone-Maintained (MM) patients.     Specifically, in a sample of MM patients, gabapentin, which has proven efficacy in treating     neuropathic pain will be evaluated for its ability to ameliorate or diminish the     opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and     tolerance to both cold-pressor and electrical pain, at peak and through methadone blood     levels. The results of this work will not only provide pharmacologic insight into the     mechanisms underlying poor pain tolerance in this at-risk population, but also direction for     the medical management of pain complicated by opioid-induced hyperalgesia.   "
158423|NCT01210066|"     Providing pain management to the patient who abuses prescription opioids presents a clinical     challenge, not only due to concerns about drug-seeking, but because they have increased     sensitivity to pain, a phenomenon identified as opioid-induced hyperalgesia (OIH). In an     effort to improve pain treatment, the aims of the proposed work are to evaluate the analgesic     and hyperalgesic effects of opioids to acute pain in this vulnerable population, and to     examine the role of opioid-induced proinflammatory changes in these responses.   "
158424|NCT01210053|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether     sunitinib is effective in treating non-small cell lung cancer.      PURPOSE: This phase II trial is studying sunitinib to see how well it works when given as     maintenance therapy in treating patients with stage III or stage IV non-small cell lung     cancer which is previously treated with combination chemotherapy.   "
158425|NCT01210040|"     A randomized double-blind controlled trial will be carried out in which young, nulliparous     (having never given birth) women will be randomly assigned to receive weekly supplementation     with either iron and folic acid or folic acid alone. Women will be followed-up weekly up to     18 months. Women who become pregnant will be followed-up until delivery. Malaria risk in both     groups will be compared by assessing the prevalence of peripheral parasitaemia at the first     antenatal clinic visit for pregnant women and at the end of the first malaria transmission     season for non-pregnant women. The incidence of clinical malaria will be assessed by active     and passive case detection throughout the follow-up period.   "
158441|NCT01209832|"     The purpose of this study is to evaluate whether tasisulam acts as an inducer of CYP3A using     midazolam as a sensitive and specific probe substrate of CYP3A.      The study will also assess the safety and tolerability of tasisulam and midazolam given in     combination and document any antitumor activity with tasisulam.   "
158431|NCT01209962|"     Patients with pancreatic cancer are treated with combinations of surgery, radiation therapy     and chemotherapy, depending on the location of the cancer and other individual patient health     factors. The goals of therapy are to reduce or eliminate the cancer cells, but without     serious damage to normal cells. Investigators at The University of Michigan are conducting a     research project, to see if treatment effects on an individual patient's cancer cells can be     detected early by new imaging tests in patients with resectable pancreatic cancer undergoing     neoadjuvant chemoradiotherapy.   "
158432|NCT01209949|"     The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat     mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and     video diaries.   "
158433|NCT01209936|"     This was a pilot study to validate the BC3 hydration factor which will be important for     determining how well this value represents hydration status compared to assessment of total     body water by D20.   "
158434|NCT01209923|"     The purpose of this study was to validate the Stayhealthy BC1 bioelectrical impedance     analyzer to assess percent body fat in children and adults. The BC1 was compared to     dual-energy x-ray absorptiometry assessment of body fat for adults and to hydrostatic     weighing assessment of body fat for children. We hypothesized that the BC1 would provide     similar measures of body fat between devices with acceptable limits of agreement.   "
158435|NCT01209910|"     Inpatients in the neurology rehabilitation units at Riverview Health Center― people who are     brain-injured and or who have had a stroke ― often have dysphagia as a result of their     condition. They are considered at high risk of aspiration, which can result in pneumonia. To     limit that risk, these patients are only allowed to consume thickened liquids at the     beginning of their rehabilitation. They are restricted from consuming thin liquids, which     means they can't even drink water. Depending on the rate of their rehabilitation, these     restrictions can last from six months to a year.      Patients on a diet of thickened liquids sometimes have difficulty consuming the required     daily intake of fluids and they become dehydrated, which in turn can lead to other health     complications. As well, thickened liquids do not always satisfy a patient's thirst, says     Pooyania.      While Riverview does not allow inpatients with dyspagia to have water at the beginning of     their rehabilitation, many rehab facilities in Canada and the U.S. follow the Frazier Free     Water Protocol, which does allow patients unrestricted water intake prior to and 30 minutes     after meals. The belief that this protocol is safe is based on research done at the Frazier     Rehabilitation Institute, where a study demonstrated no difference in rates of aspiration     pneumonia between an experimental group on a free water protocol and a control group.      The Frazer study was only one randomized controlled trial with a very limited number of     patients. There have been a few case reports as well, but at Riverview centre, the protocol     is not accepted because the investigators don't believe there is enough evidence behind it.     The investigators intend to provide more clinical evidence so that both the risks and     benefits of a free water protocol can be assessed.      The investigators will be screening patients admitted to the neurology rehabilitation units     at RCH, including both the stroke and acquired brain injury programs. The investigators     expect to find at least 30 suitable candidates.      Participants will be educated about dysphagia and the free water protocol, and the treatment     group will be allowed unrestricted water intake prior to and 30 minutes after meals.     Individualized intervention to minimize aspiration will be provided. Daily and weekly     monitoring and testing of all patients will take place. The pilot study will continue for 11     months. A secondary objective of the research is to determine the feasibility of expanding     into a multi-centre clinical trial   "
158436|NCT01209897|"     The topic of this research is cigarette smoking cessation. We designed four smoking cessation     booklets. These booklets are designed for smokers who differ in their motivation to quit     smoking. We will compare different ways of matching booklets to smokers who vary in their     motivation to quit smoking.   "
158437|NCT01209884|"     This research is being done to learn more about healthy aging. We hope to learn which bodily     processes or functions are important for the elderly to maintain good health. Metabolites     (for example, glucose) are small molecules in our bodies that are used in all bodily     reactions. Looking at their levels in healthy elderly people may help researchers find out     which processes lead some people to get to disease and others to not.      Metabolites are the basic building blocks for people. They are used to construct larger     complexes(such as proteins), relay signals from one part of the body to another, and as a     source of energy.      While most people have essentially the same types of metabolites, the relative levels of     these metabolites vary from one individual to another. These levels reflect the body's state     of growth, development, and reproduction. An appropriate balance in metabolites is important     to maintaining general health. Conditions like cancer and diabetes result in disrupted levels     of metabolites that are associated with changes in bodily functions. Deviations from normal     levels of metabolites can be used as a signature for disease. Researchers have discovered     that a disruption in unique metabolite levels is associated with human aging. In this study     we hope to learn which, if any, of these disruptions are associated with the onset of     age-related disease.   "
158438|NCT01209871|"     The goal of this clinical research study is to find the highest tolerable dose of a cancer     vaccine that can be given to patients with asymptomatic lymphoplasmacytic lymphoma (LPL). The     safety of this vaccine is also being studied.   "
159006|NCT01202409|"     The goal of this clinical research study is to learn if panitumumab can help to control     advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be     studied.   "
158442|NCT01209819|"     Hyperphenylalaninemia (HPA) is a rare metabolic disorder caused by a deficiency of the enzyme     phenylalanine hydroxylase (PAH). Elevated plasma levels of phenylalanine (phe) cause mental     retardation, microcephaly, delayed speech, seizures, eczema, and behavior problems. Adequate     control of the plasma levels of phe by a phe-restricted diet can prevent the developmental     and behavioral problems.      The foundation of this diet is a phe-free medical product/formula made from free amino acids.     Based on longitudinal studies, it has been reported that the most benefit is attained by     individuals who maintain a phe-restricted diet throughout life. Despite the obvious benefits     of the diet, it has been suggested that the dietary restrictions may be associated with poor     bone health in these patients. However, data supporting this has been reported in studies     with small sample sizes and/or inadequate sample populations that include children. There is     a paucity of data on bone health in adults with HPA.      The investigators propose an observational study to describe the bone health status among     adults with a diagnosis of HPA and to compare them to established normative age and     gender-specific values among healthy individuals. The investigators hypothesize that adults     with HPA will have lower bone density as measured by a dual x-ray absorptiometry (DXA) scan     compared to the established normative values.   "
158443|NCT01209806|"     The purpose of this study is to determine whether the administration of PEG along with     simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection.   "
158444|NCT01209793|"     This study is being conducted to assess the safety and tolerability of a single ascending     intravenous (IV) dose of REGN846 in healthy volunteers.   "
158446|NCT01209767|"     This study intended to investigate and compare the changes that may occur in response to     cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. The     cryolipolysis cooling device used is FDA approved for skin cooling, but still investigational     in the treatment of cellulite. It has previously been used for fat reduction on love handles     or back fat. During cryolipolysis, the system drew fat tissue into an applicator then exposes     the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die,     with the goal to decrease the raised areas of cellulite. Subcision is a process used to treat     scars left behind by acne or other skin diseases and has been noted to improve moderate to     severe cellulite. Subcision is a simple surgical procedure that is performed by inserting a     specially designed needle under the skin after local numbing medication is injected. The     needle is moved in a repetitive motion parallel to the skin to separate the surface tissue     from the deeper scar tissue with the goal to improve the dimpling caused by these tissues     sticking together. This study was a pilot study designed to determine feasibility of these     procedures.   "
158447|NCT01209754|"     The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of     Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective     observational cohort investigation of exposures to study agents under investigation for HIV     prevention. The study population will consist of female participants who are identified as     becoming pregnant during their participation in a microbicide or PrEP trial, or who have had     planned exposures in pregnancy safety studies as well as their babies resulting from these     pregnancies. This study will only enroll babies who have not yet reached their 1 year birth     date.   "
158448|NCT01209741|"     This study will evaluate the comparative bioavailability of three capsule formulations of     MK-0974.   "
158449|NCT01209728|"     This is a double-blind, parallel design study in elderly primary insomnia patients and     demographically matched controls. The objectives if this study are primarily: 1. To determine     if functional deficits in simulated driving performance can be demonstrated in primary     insomnia patients, and detected in healthy volunteers, impaired by alcohol; and secondarily:     2. To compare simulated driving performance deficits in elderly primary insomnia patients to     those in healthy elderly volunteers impaired by alcohol, for at least one of the following     driving endpoints: standard deviation of lane position (SDLP), standard deviation of speed     (speed deviation), lane excursions, and a driving composite score.   "
158450|NCT01209715|"     In the present study, the investigators wish to address the effect of a     glucocorticoid/long-acting beta-agonist preparation on endothelial function in COPD patients     who do not currently smoke (ex-smokers) by measuring endothelium-dependent (albuterol     response) and endothelium-independent (NTG response) vasodilation in the bronchial artery,     reflecting endothelium-dependent and endothelium-independent vasodilation (drug-induced     increase in Qaw, ΔQaw). With this approach the investigators will test the hypothesis that in     stable ICS-naïve COPD patients, endothelium-dependent vasodilation is restored with a     glucocorticoid/long-acting beta-agonist preparation, presumably resulting from the     glucocorticoid component.   "
158451|NCT01209702|"     This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy     of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have     failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor necrsos     factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized to     receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for 12     weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4     mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be     followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week     208 for all patients. Anticipated time on study treatment is 208 weeks.   "
158452|NCT01209689|"     This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of     tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an     inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were     randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv)     or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by     open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all     patients.      This study and all further clinical development of tocilizumab AS was halted after a review     of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in     TNF antagonist naïve AS patients, failed to demonstrate efficacy.   "
158453|NCT01209676|"     A phase 0, exploratory study of the pharmacodynamics of a single intratumoral dose of     IMCgp100, a monoclonal T cell receptor anti-CD3 scFv fusion protein, in subjects with     advanced unresectable melanoma to assess the safety and pharmacodynamic properties of single     intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma. Six patients     will be enrolled to complete the study over approximately 12-15 months.   "
158454|NCT01209663|"     The objective of this trial is to evaluate postoperative intermediate care versus ward care     in patients who have undergone emergency abdominal surgery with a perioperative Acute     Physiology and Chronic Health Evaluation (APACHE) II score ≥ 10 (high risk patients).      Patients will be enrolled in the trial, if they are ready to be discharged from the recovery     unit or intensive/intermediate care unit to the surgical ward within 24 hours after surgery.     Discharge criteria will be according to the Danish national recommendation.      The intermediate care bed in the trial is defined by a certain minimum requirements to     patient observation and described treatment possibilities which have to be available to the     intermediate bed. If the treatment exceeds these treatment possibilities, the patient will be     classified as an intensive care patient. The intermediate care bed will be placed at an     intensive care unit, recovery unit or a surgical high dependency unit. If there is no     available intermediate care bed, the patients will not be randomized, but only registered as     excluded because of no available intermediate care bed.      Hypothesis: Postoperative intermediate care for 48 hours or more will reduce the 30-day     mortality in emergency abdominal surgery patients with a high risk of postoperative organ     failure.      Interim analysis: An independent Data Monitoring and Safety Committee (DMSC) will conducted     the interim analysis based on the analysis of the primary outcome blinded for intervention     allocation. The DMSC will use P<0.001 (Haybittle-Peto) on two subsequent interim analyses as     the statistical limit to guide its recommendations regarding early termination of the trial     for benefit or harm. The first interim analysis will be conducted when the 30 days follow-up     data of about 50% (i.e., about 200 patients) of the trial participants have been obtained     and/or 75 deaths have been documented during the trial. If P<0,001 in the first interim     analysis a second interim analysis will be conducted when the 30 days follow-up data of about     75% (i.e., about 300 patients) of the trial participants have been obtained and/or 25 deaths     have been documented during the trial.      Trial terminated on the 30th November 2012. The Data Monitor Committee found a very low     overall event rate of the primary outcome at the first interim-analysis as compared to the     pre-trial estimated. This precluding any possibility to detect or reject the anticipated     relative risk reduction of 34 % as used in the sample size estimation.   "
158472|NCT01209429|"     This study will investigate whether growth hormone is modulated by the enzyme SIRT1 and by     that is stimulating lipolysis on expense of IGF-I production. This is done in 10 healthy men     on calorie restriction on 4 study days with fat and skeletal muscle biopsies.   "
158455|NCT01209650|"     The program will provide early access to the investigational drug BIBW 2992 to treat patients     with advanced NSCLC who have failed at least 12 weeks on erlotinib or gefitinib.      The Compassionate Use Programme will also provide additional safety and efficacy information     on BIBW 2992 use.      Named Patient Use (NPU)   "
158456|NCT01209637|"     Exercise training in patients with coronary artery disease is able to correct several risk     factors. Furthermore endothelial function can be improved.      There are some hinds for improved collateral circulation after exercise training,     nevertheless there is no study showing significant improvement/ increase in coronary     collaterals. This might be due to technique of collateral measurement. Therefore we conduct a     study were coronary blod flow before and after 4 weeks of exercise training were measured.   "
158457|NCT01209624|"     The purpose of this study is to assess the long-term efficacy and safety of latanoprost     monotherapy in patients with normal tension glaucoma (NTG) using a prospective, observational     design. Visits were scheduled at 6-month intervals for 24 months. Intraocular pressure (IOP),     optic nerve head findings, visual field status, and adverse events were recorded.   "
158458|NCT01209611|"     The purpose of this study is to evaluating whether autologous bone marrow mononuclear cells     transplantation is safe and/or effective to accelerating skin regeneration and soft tissue     expansion.   "
158459|NCT01209598|"     The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance)     (formerly known as PD0332991) has on the patient and on the liposarcoma.      Palbociclib is an investigational drug. An investigational drug is a medication that has not     been approved for marketing by the Food and Drug Administration (FDA). Palbociclib blocks a     protein called CDK4 which is part of a pathway in liposarcoma cells that is over-active. The     investigators hope that blocking CDK4 will shut down this pathway in the liposarcoma cells     and stop tumors from growing. Palbociclib is an oral medication.   "
158460|NCT01209585|"     The purpose of this study is to study the evaluation of blood samples and blood types to     identify functional protein in the joints.   "
158461|NCT01209572|"     At this time, 24h energy expenditure is rarely assessed under free-living conditions for     specific individuals because of the lack of cheap and accurate software/materials to record     the energy expenditure. Some affordable and convenient tools (Polar heart rate monitor,     Actiheart, SenseWear Armband) are available on the market but the predictive equations     comprised into the software provided with these tools generally miscalculate the energy     expenditure (by about +/-10%). Because of this deficiency, the investigators have a poor     knowledge of the modification of the energy expended during daily life activities and over     24h in subjects belonging to groups of various ages and physiological states. The     investigators hypothesise that it could be possible to improve the energy expenditure     prediction.      The project aims at providing a mathematical model (equations) that predicts energy     expenditure with an error near to 5%. Two groups of 60 sedentary to athletic normal weight     volunteers aged between 18-60 years participate to this study. The first group stay for 26h     in calorimetric chambers. During this stay energy expenditure ,heart rate, accelerometry, and     other parameters are recorded during various activities. These data will serve to construct     the model. The same type of recordings are performed on second group of volunteers in free     living conditions. Their energy expenditure is measured overall by doubly labeled water. The     data of the second group will serve to validate the model. The error percentage of the model     is defined by the ratio of the value of the difference between prediction and reference     measure to the reference measure. Concordance between predictions and measures will be     evaluated by Bland - Altman plots.   "
158462|NCT01209559|"     The objective of this study is to determine if the glottic view obtained with the air-Q     Intubating Laryngeal Airway (air-Q ILA, Cookgas LLC®, Mercury Medical®, Clearwater, FL, USA)     is better than that obtained with the traditionally used intubating laryngeal mask airway     (LMA FastrachTM or ILMA, LMA North America Inc., San Diego, CA). The study will also compare     effectiveness of ventilation.   "
158463|NCT01209546|"     The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.   "
158464|NCT01209533|"     The purpose of the study is to determine if inhaled iloprost given four times daily can     improve symptoms and lung function in adults with mild asthma.   "
158559|NCT01208272|"     Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating     disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but     its long-term impact and time course on other BED-related symptoms remain largely unknown.     This study compares the effects of group CBT and group IPT across BED-related symptoms among     overweight individuals with BED.   "
158465|NCT01209520|"     The trial investigates the feasibility and efficacy of targeting Non-Small Cell Lung Cancer     (NSCLC) driven by epigenetic changes. The investigators study the impact of 5-azacitidine     (Vidaza®, Celgene, Summit, NJ, USA) in combination with conventional cytotoxic chemotherapy     in a sequential fashion. The study population consists of all NSCLC patients who undergo     curative lung cancer resection and whose tumors harbor hypermethylation in any of the     protocol-specific genes (samples will be banked for additional molecular testing including     other 21 loci which have shown to be important in lung carcinogenesis.   "
158466|NCT01209507|"     Gynecologic Oncology patients have several different chemotherapy regimens, and dexamethasone     is now routinely given to prevent allergic reactions to the chemotherapeutic agents. The most     common chemotherapeutic agents used are paclitaxel and carboplatin. This combination regimen     is given every three weeks for a total of 5-6 doses. Each dose is given after administration     of 20 mg dexamethasone twelve hours prior to and the morning of chemotherapy. Dexamethasone     is used for its antiemetic effects, but also to minimize the potentially fatal     hypersensitivity reaction that can occur with paclitaxel. Another commonly used chemotherapy     regimens is weekly cisplatin given with one dose of dexamethasone for cervical cancer.     Chronic steroids are known to cause adrenal suppression, but it is not known if the amount of     dexamethasone given with the gynecologic cancer chemotherapy regimens described above causes     adrenal insufficiency in these patients. The investigators hypothesis is that some women     receiving steroids with their chemotherapy may have adrenal insufficiency, and that they will     have greater than normal chemotherapy-related fatigue.   "
160110|NCT01187823|"     The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto SV     Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep     apnea.   "
158467|NCT01209494|"     The prospective EUTrigTreat multi-center study is an observational, advanced diagnostics and     genetic risk stratification trial in patients with standard indications for ICD treatment,     with and without myocardial infarction in their history.      Its aims are fourfold: 1) To accurately risk stratify a large cohort of implantable     cardioverter-defibrillator (ICD) patients for ICD shock risk and mortality using traditional     risk markers as well as genetic markers 2) To find a link between repolarization biomarkers     and genetic markers of calcium metabolism. 3) To compare invasive and noninvasive     electrophysiologic (EP) testing systematically 4) To assess temporal changes of typical     noninvasive risk stratifiers and their prognostic implication.      In five European academic clinical centers, 700 ICD patients are prospectively enrolled     (optionally the number of enrolled patients may be expanded to 1000 patients). Comprehensive     non-invasive risk stratifying ECG diagnostics including beat-to-beat variability of     repolarization (BVR) are applied, and candidate genes associated with malignant arrhythmias     are analyzed. Programmed electrical stimulation is performed to test for inducibility of     malignant ventricular arrhythmias and BVR. In a subset of patients, electrophysiologic     studies include recording of monophasic action potentials (MAP) from the right ventricle for     assessment of restitution properties. Non-invasive risk stratifying ECG methods are repeated     annually. Outcome (mortality, ICD shocks) will be assessed until September 2014.   "
158468|NCT01209481|"     The right to food and nutrition is established in the Universal Declaration of Human Rights     as they are basic requirements for promoting and protecting good health. They can also be     instruments to evaluate the quality of life of human beings and communities. Awareness of a     healthy diet is the first step in behavioral change, and nutritional education can be an     instrument for avoiding diseases resulting from both intake deficit and excess. Educational     group actions can change food intake. This study will aim at evaluating, planning and     implementing the impact of a nutritional education group action concerning the consumption of     fruit and vegetables in adult and elderly individuals attended to by a Primary Health Care     (PHCU) Unit. It will be a randomized assay involving two groups comprising male and females     individuals distributed in the following fashion: Intervention Group, in which the     educational group action (EGA) will be performed in addition to routine activities; and     Control Group, the individuals from which will only participate in the routine activities in     the PHCA (Teaching Health Care Unit). The total sample will comprise 80 individuals with 40     in each group. In order to determine the consumption of fruit and vegetables, a weekday and a     Sunday 24-hour recalls will be performed 2 (short-term effects) and 6 (medium-term effects)     months after completing the intervention. The educational group activities will consist of     two-hour group dynamics and cooking workshops once a week and for five weeks. Serum     carotenoid dosages will also be performed in the two groups by sub-sampling (n=40) with the     purpose to validate the estimated intake of fruit and vegetables obtained from the recalls.   "
158469|NCT01209468|"     Obstructive sleep apnoea (OSA) is a serious and common disorder affecting one in twenty-five     men and one in fifty women over the age of 30. This breathing abnormality occurs during sleep     and is characterised by snoring and episodes of sleep disturbances. The symptoms of untreated     OSA (e.g. excessive daytime sleepiness), can result in significant reductions in the     patients' quality of life. The key treatment modalities today include Continuous Positive Air     Pressure (CPAP), surgery and the use of oral appliances (OAs). Increasingly, OAs have been     advocated in the treatment of the symptoms of OSA since they offer a non-invasive form of     treatment and also because patients often prefer this treatment to other treatment     modalities. There is increasing evidence to support the effectiveness of OAs in the     management of OSA, at least as a short term measure. What is still unclear is which types of     OA are most effective and whether OAs are effective in the long term management of OSA. This     randomized clinical trial aims to evaluate two differently designed OAs in terms of their     effect on patients' quality of life and on the physiological symptoms of OSA     (apnoea/hypopnoea index AHI). Around 45 patients with OSA will be recruited from a pool of     patients referred to the dental hospital for treatment from the medical faculty. The     treatment with OAs will commence after randomization to two treatment groups; follow-up     examinations will take place over a period of 12 months. The results of this study will help     inform practitioners and patients of the feasibility of using OAs in the long term management     of OSA and help determine the most appropriate type of OAs for the management of OSA and     improvement in quality of life.   "
158560|NCT01208259|"     Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating     disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but     its long-term impact and time course on other BED-related symptoms remain largely unknown.     This study compares the effects of group CBT and group IPT across BED-related symptoms among     overweight individuals with BED.   "
158470|NCT01209455|"     Paracetamol overdose is the leading cause of acute liver failure in the Western World.     N-acetylcysteine (NAC) has been the antidote of choice for over 30 years but its use is     associated with adverse effects in 40% of cases. Patients characteristically experience     nausea, vomiting and an anaphylactoid ('pseudo-allergic') syndrome. This reaction is     clinically similar to true anaphylaxis (allergic reaction) including flushing, rash,     constriction of airways, and a fall in blood pressure, but occurs via a different mechanism.     Although treatable, these reactions lead to patient distress, commonly cause confusion among     treating physicians, and lead to significant delays in antidote administration. The aetiology     of these adverse reactions to NAC remains unclear. We hypothesise: i) these reactions result     from a dose-dependent release of the chemical histamine, causing dilatation of blood vessels     (vasodilatation) and the anaphylactoid syndrome; ii) paracetamol conversely exerts a     protective effect on the reaction, with a less severe reaction observed in the presence of     higher paracetamol concentrations. We will investigate the mechanisms underlying adverse     reactions to NAC in the human forearm model, examining the role of histamine and other     markers involved in the inflammatory process. The wider significance is an improved     understanding of this poorly delineated phenomenon, with implications for other medications     associated with similar reactions, such as non-steroidal anti-inflammatory drugs and opioids     such as morphine.   "
158471|NCT01209442|"     The purpose of this study is to find out whether Hypofractionated Intensity-Modulated     Radiation Therapy (Hypo-IMRT) combining with temozolomide chemotherapy can be safely given     with a targeted agent, bevacizumab, and how effective this study treatment will be in     controlling your brain tumor.   "
158475|NCT01209390|"     The objective of this post-marketing study is to confirm the clinical efficacy and safety     outcome of treatment with ChondroMimetic in a patient population within the proposed     indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up     period.      The primary objective is to collect post-marketing safety data in a real life setting by     means of (S)ADR reporting.      The secondary objectives are:        -  Clinical outcome as assessed by patient reported EuroQoL-5D        -  Structural repair as assessed by MRI        -  The number of treatment failures and the time to treatment failure        -  The ease of use of ChondroMimetic as reported by the surgeon   "
158476|NCT01209377|"     EMDR (Eye Movement Desensitization and Reprocessing) is an exposure-based procedure for the     treatment of patients with post-traumatic stress disorder (PTSD). Although the efficiency of     EMDR-treatment is empirically proven, it remains unclear whether the bilateral stimulation     triggered via eye movements has specific effects on treatment outcome. Hypothesis explaining     the efficacy of the EMDR treatment are: focussing on the moving hand triggers an orientation     reaction, and the duality of alertness focus during trauma exposition causes a distraction of     the traumatic topic.      Within a randomized controlled study 120 patients will be treated during 8 therapeutical     sessions with EMDR with bilateral stimulation or one of two control conditions: EMDR without     bilateral stimulation (eyes on a fixed, unmoving hand) and exposition without any visual     stimuli to focus attention on. Primary outcome are scores on an interview measure for PTSD     symptoms (Clinician Administered PTSD Scale (CAPS))as assessed pre-treatment and after     treatment (max 8 sessions of psychotherapy).      The following hypothesis are investigated in the study:        1. EMDR treatment with bilateral stimulation through eye movements will be followed          significant larger reduction in CAPS compared with EMDR treatment without bilateral          stimulation (specific treatment effect of eye movements)        2. EMDR with eyes fixed will be followed by a significant larger reduction in CAPS compared          with EMDR without external focus (specific treatment effect of distraction)   "
158477|NCT01209364|"     The primary objective is to determine whether Durolane is non-inferior to methylprednisolone,     as assessed by level of pain, when each are given as single intra-articular injections for     the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.   "
158478|NCT01209351|"     The primary objective of this study is to assess the effects of 10 consecutive, daily,     subcutaneous doses of 4 mg of teduglutide as compared with placebo on gastric emptying as     assessed by acetaminophen absorption kinetics in healthy subjects.   "
158479|NCT01209338|"     The overall program goal is to determine the Acceptability and Feasibility of introducing a     population based Human Papilloma Virus (HPV) Vaccination programme and understanding the key     individual and community factors that would determine the potential acceptability of the     vaccine.   "
158480|NCT01209325|"     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective     immune response to prevent viral infection.      PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human     papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.   "
158496|NCT01209104|"     GSK1325756 is a potent, competitive, selective and reversible CXCR2 receptor antagonist that     is being developed as a once-daily oral anti-inflammatory medication for the treatment of     chronic obstructive pulmonary disease (COPD). Selective antagonism of the interaction between     CXCR2 and its various chemokine ligands is a potential strategy for reducing the underlying     inflammation in COPD via the inhibition of neutrophil recruitment and activation. The current     study explores the effects of age, gender and food (high fat meal) on the pharmacokinetics of     GSK1325756.      Because a significant proportion of COPD subjects are prescribed proton pump inhibitors     (PPI's) such as omeprazole in order to alleviate symptoms of gastro-esophageal reflux disease     (GERD), it is important to understand the absorption of the current formulation of GSK1325756     in an environment of raised intra-gastric pH as will be encountered in patients taking PPI's.     Therefore, this study will also evaluate the impact of the proton pump inhibitor omeprazole     on the pharmacokinetics of GSK1325756.   "
158481|NCT01209312|"     The investigators are hoping to figure out how youth with type 1 diabetes can best control     their blood glucose levels after meals, by determining whether accurate carbohydrate dosing     or the timing of the bolus is more important. There is evidence to suggest that each strategy     is important for blood glucose control. Unfortunately, for some people, prebolusing is     difficult, because they may not know how much they are going to eat. To give an exact dose of     insulin 20 minutes before a meal can be difficult. In this study, the investigators would     like to show that taking even just part of the insulin bolus 20 minutes before the meal is     preferable to waiting until mealtime and taking the entire bolus. To do this, the     investigators will have 24 patients in the study, who will each spend 4 mornings at The     investigators clinic. The order of the visits will be selected randomly. The visits will     include: taking full bolus at mealtime, taking full bolus 20 minute before mealtime, taking ½     bolus at mealtime, and taking ½ bolus 20 minutes before mealtime. At each visit, the person     will eat the same meal, but the timing and amount of the bolus will be different. The     investigators will measure the blood glucose levels with a blood glucose meter, and also with     a laboratory test called YSI. The investigators will also be measuring the glucose levels     under the person's skin with a continuous glucose monitor. The investigators will compare the     area under the curve for the different visits, as well as the glucose levels at different     points after the meal.   "
158482|NCT01209299|"     RATIONALE: Studying samples of tissue in the laboratory from patients receiving carboplatin     and paclitaxel with or without sorafenib tosylate may help doctors learn more about the     effects of this treatment on cells. It may also help doctors understand how well patients     respond to treatment.      PURPOSE: This research study is studying biomarkers in predicting response to chemotherapy in     patients with advanced or metastatic melanoma previously treated with carboplatin and     paclitaxel with or without sorafenib tosylate.   "
158483|NCT01209286|"     The purpose of this study is to determine whether the bispecific T-cell engager blinatumomab     is effective, safe and tolerable in the treatment of patients with relapsed/refractory     B-precursor ALL.   "
158484|NCT01209273|"     The objective of this study is to compare Quality of Life (QoL) between Automated Peritoneal     Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis (CAPD).   "
158485|NCT01209260|"     This is a randomized controlled trial examining whether a mechanical needle versus a needle     that uses radiofrequency energy is better at puncturing through a thin wall in the heart     (called transseptal puncture) as measured by procedure time, during an electrical     procedure/study of the heart .   "
158486|NCT01209247|"     The emergence of resistance to fluoroquinolone (FQ) is a major problem worldwide. The     commensal flora is the main reservoir for antibiotic resistance. Understanding the factors     (environmental, patient-related, dosis-related, drug-related…) involved in the emergence of     resistance to fluoroquinolones in the commensal flora of patients treated with a FQ, may help     prevent it and preserve the efficiency of these important antibiotics. Samples of rectal,     nasal and pharyngeal flora will be collected from hospitalized patients before receiving a     FQ, at the end of the treatment and 1 month after the end of treatment. Clinical data will be     collected. The incidence and risk-factors associated with the emergence of resistance to FQ     will be assessed by comparing groups with and without resistance both at the end of treatment     and 1 month later.   "
158487|NCT01209234|"     This randomized controlled trial will compare strategies to reduce the risk of     methicillin-resistant Staphylococcus aureus (MRSA) infection and re-hospitalization in MRSA     carriers. This trial will provide critical answers about the role of decolonization versus     standard-of-care education in preventing MRSA infections in the large group of high risk     MRSA-positive patients being discharged from hospitals. Findings could potentially impact     best practice for the 1.8 million MRSA carriers who are discharged from US hospitals each     year.   "
158488|NCT01209221|"     This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate     the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses     of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a     single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983     or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks     for the SAD part and up to 8 weeks for the MAD part.   "
158489|NCT01209208|"     The purpose of this study is to determine whether budesonide or mesalazine is more active in     the treatment of lymphocytic colitis.   "
158490|NCT01209195|"     This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in     combination with paclitaxel using a 3+3 design.   "
158491|NCT01209169|"     The purpose of this study is to collect blood and urine samples that may help identify and     validate biomarkers for the early detection and risk assessment of acute kidney injury (AKI).   "
158492|NCT01209156|"     The underlying goal of this study is to assess PBR-111 positron emission tomography (PET)     imaging as a tool to detect microglial activation in the brain of Alzheimer disease (AD)     research participants and age- and gender-matched healthy volunteers.   "
158493|NCT01209143|"     This is a single-arm, multicenter, Phase Ib study designed to describe the effect of GDC-0449     on the pharmacokinetics of rosiglitazone and oral contraceptives in patients with advanced     solid tumors who are refractory to treatment or for whom no standard therapy exists.   "
158494|NCT01209130|"     This is a Phase I, multicenter, open-label, dose-escalation study of DCDT2980S administered     by intravenous (IV) infusion to patients with relapsed or refractory hematologic     malignancies. In addition, at selected sites, DCDT2980S will be studied in combination with     rituximab.   "
158495|NCT01209117|"     This is a single-center, randomized, two part, open-label, crossover study in healthy adult     subjects to assess the oral bioavailability of three GSK2248761 Wet Bead Milled (WBM) tablet     formulations manufactured by three different processes relative to the GSK2248761 WBM capsule     formulation (Part A) and the effect of a moderate-fat meal on the bioavailability of the     selected WBM tablet formulation (Part B).   "
158561|NCT01208246|"     The purpose of this study is to understand the effect of the pregnancy on the muscles in the     pelvis. The purpose of this study is to evaluate the pelvic muscle changes related to     pregnancy; to assess if the ability to squeeze and relax these muscles has any effect on     delivery mode and if there are any injuries to the pelvic muscles.   "
158497|NCT01209091|"     Introduction: Many reimbursement authorities use economic evaluation to help guide decisions     regarding the adoption of new treatments in reimbursement systems. Survival and quality of     life are often the main measure of benefit used in an economic evaluation - expressed as a     quality adjusted life year (QALY). In addition though, some decision makers will also     consider the impact of a treatment on a patient's ability to continue working (expressed in     terms of productivity). The aim of the present study is to estimate quality of life weights     (utilities) and productivity loss for women with metastatic breast cancer (Human Epidermal     Growth Factor Receptor 2 positive or HER 2+).      Methods: Separate surveys will be used to assess utilities and productivity in HER2+     metastatic breast cancer (MBC). To capture utilities health state descriptions or vignettes     describing progressive disease, stable disease, and seven grade 3/4 adverse events     (diarrhoea, fatigue, anaemia, leukopenia, anorexia, decreases in left ventricular ejection     fraction (LVEF), and skin rash) will be developed. The vignettes will be developed based on a     literature review and in depth interviews with women with MBC in the Netherlands and Sweden.     Clinical experts in both countries will review the health states for content validity. The     health states will be translated using forward and back translation. Members of the general     public will rate the states (100 men and women in NL; 100 women aged 50+ in Sweden) using the     visual analogue scale and Time Trade Off method to determine utility values. In a separate     survey women who are currently being treated or have recently completed their treatment for     MBC will be surveyed regarding the impact of disease on their ability to work using a     validated work productivity measure (Work Productivity and Activity Impairment) in women in     the Netherlands and Sweden.   "
158498|NCT01209078|"     This study will determine the safety, tolerability and efficacy of GSK1322322 verses     Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).   "
158506|NCT01208974|"     Overall rationale: Prophylactic NAC irradiation after nipple-areola sparing mastectomy and     immediate reconstruction for patient with ductal carcinoma in-situ or invasive breast cancer     will allow better cosmesis and patient's satisfaction.      Study design: Phase I trial assessing the safety, feasibility and toxicity of prophylactic     NAC irradiation after nipple-areola sparing mastectomy and immediate reconstruction in     patients with ductal carcinoma in-situ or invasive breast cancer.      Primary objective: To determine the recommended phase I dose of post-operative prophylactic     NAC irradiation.      Secondary objectives: To provide extensive descriptive data regarding NAC-sparing surgery     with reconstruction, including both surgeon experience and patient evaluation of cosmetic     results. Survival and recurrence will be assessed.      Study size: Between 12 and 18 patients will be enrolled in this phase I study.   "
160778|NCT00000215|"     The purpose of this study is to evaluate the effects of pergolide on cocaine taking and on     the physiological and subjective effects of cocaine, including cocaine craving in non-opiate     dependent cocaine users.   "
158499|NCT01209065|"     GSK1349572 is an integrase inhibitor being developed for the treatment of human     immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV     HealthcareLLC. In HIV-infected patients where combination antiretroviral therapy is the     standard of care, it is likely that it will be dosed with boosted protease inhibitors (PIs)     including fosamprenavir/ritonavir (FPV/RTV or FPV/r). As FPV and RTV are modulators     (induction as well as inhibition) of Uridine diphosphate glucuronosyltransferase (UGT) and     Cytochrome P450 (CYP)3A which are the primary and secondary metabolic pathways of GKS1349572,     it is likely that FPV/RTV will affect the pharmacokinetics (PK) of GSK1349572, therefore a     drug interaction study is warranted and will be evaluated in Part A of this study. Part B     will evaluate the effect of particle size of tablet variants on the PK of GSK1349572.      In Part A, approximately 12 subjects will receive GSK1349572 50mg every 24 hours (q24h) for 5     days (Treatment A). Subjects will then be administered GSK1349572 50mg q24h in combination     with FPV/RTV 700/100 mg every 12 hours (q12h) (Treatment B) for 10 days. There will be no     washout between treatments. In Part B 15 subjects will receive a single 50 mg dose (2 x 25mg     tablet) in 3 different tablet variants of the same formulation, differing only in particle     sizes of GSK1349572, under fasted conditions in a three-way crossover design. Safety     evaluations and serial PK samples will be collected during each treatment period. A follow-up     visit will occur 7-14 days after the last dose of study drug.   "
158500|NCT01209052|"     This study aims to investigate the safety, tolerability, pharmacokinetics and     pharmacodynamics of single, oral ascending doses, and repeat oral doses of GSK1325756     administered to healthy adult male volunteers. This study is the First Time in Human study     for GSK1325756.   "
158501|NCT01209039|"     This study described in the present protocol consists of two parts. Part A is a multiple     ascending dose study to evaluate the safety, tolerability and pharmacokinetics of ascending     doses of GSK1144814. Part B is an open label design in healthy male subjects to assess the     GSK1144814 Neurokinin1 receptor occupancy.   "
158502|NCT01209026|"     A randomised, placebo controlled thorough QTc study to evaluate the effect of repeat dose     FF/GW642444M combination, with moxifloxacin as a positive control, on the QTc interval in     healthy male and female subjects. Key assessments will include 12- lead electrocardiogram     (ECG) and pharmacokinetic (PK) parameters, along with safety being assessed by blood     pressure, heart rate, clinical laboratory safety tests, and collection of adverse events.   "
158503|NCT01209013|"     Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a     non heated laser. The activation of the drug is done by lighting of abnormal areas using a     fiber optic device. The fiber optic device is a very fine fiber (like a fishing line) that     permits transmission of light. The fiber optic device is inserted into a diffusing balloon     device to ensure the good positioning of the fiber optic within the esophagus (food pipe). It     is thought that the size and the flexibility of a new diffusing balloon device could improve     the safety profile of the photodynamic treatment by reducing the risk of narrowing or closure     of the food pipe (esophageal stenosis) sometimes occurring after treatment.      This research study will evaluate the safety and effectiveness of PDT with porfimer sodium     using a new diffusing balloon device for light application in the removal of high-grade     dysplasia (HGD, precancerous change in the food pipe tissue) in Barrett's esophagus (BE).     This study will provide advanced knowledge about phototoxicity (reaction similar to sunburn)     and esophageal stenosis, main risks with this therapy. It will involve 75 patients with HGD     in BE across North America and Europe and will last between 13 and 16 weeks. In addition,     concentrations of porfimer sodium in the esophageal tissue will be analyzed in a subgroup of     patients.   "
158504|NCT01209000|"     Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous     nephropathy (MN), generate an enormous individual and societal financial burden, accounting     for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual     cost in the US of more than $3 billion. However, the clinical classification of these     diseases is widely believed to be inadequate by the scientific community. Given the poor     understanding of MCD/FSGS and MN biology, it is not surprising that the available therapies     are imperfect. The therapies lack a clear biological basis, and as many families have     experienced, they are often not beneficial, and in fact may be significantly toxic. Given     these observations, it is essential that research be conducted that address these serious     obstacles to effectively caring for patients.      In response to a request for applications by the National Institutes of Health, Office of     Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a     number of affiliated universities joined together with The NephCure Foundation the NIDDK, the     ORDR, and the University of Michigan in collaboration towards the establishment of a     Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium.      Through this consortium the investigators hope to understand the fundamental biology of these     rare diseases and aim to bank long-term observational data and corresponding biological     specimens for researchers to access and further enrich.   "
173875|NCT00118378|"     This study will determine whether modafinil (Provigil®), a medication approved for the     treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.   "
158505|NCT01208987|"     The investigators plan to develop a process to create an Enhanced Medication List. The INPC     (Indiana Network for Patient Care) already obtains histories of medications dispensed by     pharmacies from several sources: pharmacy benefit managers, RxHub, insurance companies,     Medicaid, SureScripts, Wishard Health Services. The investigators will collect all the     medication data available through the INPC for an individual patient. The investigators will     enhance this medication list by including medication categories, improving the structure and     appearance, displaying results of relevant laboratory tests, and adding decision support     reminders. The investigators will test the value of such an Enhanced Medication List by     providing it to outpatient physician practices (through the DOCS4DOCS clinical messaging     service, or as a fax), preferably on the day that the patient has an office visit with the     physician. The investigators will determine whether this intervention improves patient care:     whether there are higher rates of recommended laboratory follow-up monitoring as a result;     whether there are lower rates of harmful drug-drug interactions. The investigators will also     seek the opinions of physicians regarding the benefit of this intervention.   "
160779|NCT00000216|"     The purpose of this study is to compare the clinical efficacy of maintenance on low and high     doses of buprenorphine with methadone for cocaine abusing opiate addicts.   "
158509|NCT01208935|"     The purpose of this study is to test the safety, tolerability, compliance and efficacy of two     different forms of nicotine replacement therapy (NRT) (the nicotine transdermal patch and the     nicotine gum) in a nicotine-dependent adolescent population.   "
158510|NCT01208922|"     The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus     Ciprofloxacin for the treatment of adults with traveller's diarrhoea.   "
158511|NCT01208909|"     In the treatment of glioblastoma (GBM) neurosurgical resection of the tumor is usually     considered a a first step of effective therapy. Radical resection of the tumor is highly     beneficial to the patient as measured in progression-free survival and overall survival. At     the same time eloquent areas of the brain have to remain intact to preserve quality of life.      Both 5-ALA fluorescence and intraoperative MRI are used for intraoperative marking of tumor     tissue and thereby to improve precision of GBM-Resection.      We now study whether the combination of 5-ALA fluorescence and intraoperative MRI increases     the number of sites where tumor tissue can be detected.      - Trial with surgical intervention   "
158512|NCT01208896|"     This trial will evaluate the efficacy and the safety of a strategy of allogeneic stem cell     transplantation including Rituximab in the conditioning regimen for the treatment of relapsed     follicular lymphoma. The rationale for using Rituximab relies on a better control of the     disease and a better prophylaxis of the graft versus host disease.   "
158513|NCT01208883|"     Treatment adaptation to biological and anatomical changes occurring during treatment can     increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer     patients. This trial investigates the feasibility of using repetitive per-treatment     [18F]FDG-PET acquired during treatment in adaptive [18F]FDG-PET-voxel intensity-based     intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head     and neck cancer.   "
158514|NCT01208870|"     The purpose of this center grant is to translate basic behavioral science on habituation     theory into clinical intervention using a vertical hierarchical approach from laboratory     studies to field studies to the clinical intervention to improve weight loss outcomes in     pediatric obesity treatment.   "
158515|NCT01208844|"     The purpose of this study is to obtain a better understanding of how stress is related to     health risks.   "
158516|NCT01208831|"     The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase     II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e.,     Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite     standard therapy or for which no standard therapy exists.   "
158517|NCT01208818|"     MYRE is a phase III multicentric controlled national clinical trial conducted in patients     with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims     are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with     cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not     requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to     biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using     either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional     high-flux dialyser, while receiving chemotherapy with BD.   "
158518|NCT01208805|"     The study first aim is to investigate the relationship between different patterns of     electrode stimulation and peripheral sensory stimulation and spinal cord-evoked potentials to     optimize spinal cord stimulation parameters . The second aim of the study is to investigate     the role of the spinal cord in some aspects of cognitive-sensory-motor processing,     specifically the presence of top-down attentional effects on the sensory analysis of an     external stimulus at the spinal cord level.      The study will be performed on patients that will be implanted with a spinal epidural     electrode because of chronic intractable pain. From these electrodes, spinal cord evoked     potentials (SCEPs) will be recorded.   "
158778|NCT01205412|"     The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV     type distribution among women ≥ 20 years of age attending routine cervical screening and     among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.   "
158519|NCT01208792|"     The investigators have recently evidenced the presence of antibodies to endothelial cells and     fibroblasts in patients with idiopathic or SSc-associated PAH. The investigators also have     identified several target antigens of anti-fibroblasts antibodies.      The objective of this study is to further investigate for the presence of antibodies to     endothelial cells and fibroblasts in patients and characterize the antigen specificity of     autoantibodies in patients with different types of non idiopathic and non SSc-associated PAH,     such as PAH associated with HIV infection, porto-pulmonary hypertension, congenital heart     diseases, systemic lupus erythematosus, mixed connective tissue disease and Sjögren's     syndrome   "
158520|NCT01208779|"     This observational study in estrogen receptor positive early breast cancer patients is aimed     to evaluate the patients' compliance to aromatase inhibitor (AI) therapy and to collect     country-specific data in estrogen receptor positive early breast cancer patients including     data on demography, disease characteristics and disease management.   "
158521|NCT01208766|"     Study phase: phase III      Study objective:        -  Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed          autologous stem cell transplantation (ASCT)        -  Comparison of Bortezomib, Lenalidomide, Dexamethasone(VRD) as consolidation versus no          consolidation        -  Comparison of single versus tandem high dose Melphalan with ASCT      Patient population: Patients with symptomatic multiple myeloma,previously untreated, ISS     stages 1-3, age 18-65 years inclusive      Study design: Prospective, multicenter, intergroup, randomized      Duration of treatment: Expected duration of induction, stem cell collection and     intensification is 6 - 9 months. Consolidation with VRD will last 2 months Maintenance     therapy with Lenalidomide will be given until relapse. All patients will be followed until 10     years after registration.   "
158522|NCT01208753|"     The purpose of the study is to evaluate the safety and tolerability of multiple ascending     oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and     to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous     suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and     pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.   "
158523|NCT01208740|"     Metformin should be administered with caution and could be potentially dangerous in infertile     patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based     ovarian stimulation. However, data that address this point are totally lacking.      On the basis of these considerations, the aim of the current clinical trial was to test the     hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who     have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF     cycles.   "
158524|NCT01208727|"     After having shown that postconditioning allowed a significant 36% reduction of infarct size     as assessed by blood levels of myocardial enzymes in acute myocardial patients, the     investigators objective is to assess the effect of postconditioning in acute myocardial     infarction (AMI) patients on microvascular obstruction lesions defined by cardiac MRI images.   "
158525|NCT01208714|"     Renal atherosclerotic stenosis (RAS) is a prevalent cause of secondary hypertension (HT).     Since there are still uncertainties as to whether and in what patients revascularization by     means of percutaneous renal angioplasty (PTRAS) should be pursued, we designed a study     exploiting an optimized patient selection strategy and using hard experimental endpoints to     unravel these uncertainties.      Primary objective: to determine if revascularization by means of PTRAS is superior or     equivalent to optimal medical treatment for preserving glomerular filtration rate in the     ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan.      Secondary objectives: to determine if the two treatments are equivalent in lowering blood     pressure (BP), preserving overall renal function and regressing damage in the target organs     of hypertension.      Design: prospective multicenter randomized, unblinded two-arm study.      Eligible patients will have clinical and/or radiological evidence of unilateral or bilateral     RAS, defined by stenosis of the proximal portion of the renal artery and its main     bifurcations at angioCT. Duplex scan will exclude nephroangiosclerosis as the latter could     bias the assessment of the outcome of revascularization.      Inclusion criteria. RAS affecting the main renal artery or its major branches at angio-CT     either > 70% or, if < 70 with post-stenotic dilatation.      Renal function will be assessed with 99mTc-DTPA renal scintigraphy.      Sample size (30 patients per arm) was calculated to have a 90% power to detect a difference     in means of GFR in the vascularized (or control untreated kidney) of 7.5 ml/min.      Arms        1. Revascularization: digital scan angiography and PTA with stenting of the renal artery at          the ostium or at truncular level, plus optimal medical therapy.        2. Medical therapy: the drug regimen that had been optimized during the run-in period.      Experimental endpoints:      The absolute value of GFR assessed by 99TcDTPA in the ischemic kidney will be used as     quantitative variable and compared between groups at each time point. A categorical     definition of kidney loss, defined as a GFR in the ischemic kidney of < 5 ml/min, will be     also used and the rate of achievement of such endpoint will be compared.      Duration: 5 years.   "
158526|NCT01208701|"     It has been documented that statin reduce mortality and morbidity in patients with     cardiovascular disease. This effect can partly be related to a reduction in cholesterol     levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as     nephropathy, diabetes and hypertension. The purpose of this study is to investigate the     effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular     variables in patients with type 2 diabetes with nephropathy.   "
158527|NCT01208688|"     The main objective of this study is to determine the effectiveness of a new treatment regime     that uses electrical stimulation for the improvement of hand function in persons with spinal     cord injuries (SCI). This treatment has been shown to be useful for stroke patients, and our     preliminary work indicates that this may also be the case with SCI patients. Our approach to     functional electrical stimulation (FES) represents a departure from the established FES     approaches, which involve developing assistive devices for permanent, everyday use. Instead,     we use FES as a therapeutic intervention that will help individuals with quadriplegia recover     voluntary grasping function. Investigators believe that subjects who undergo FES therapy     should be able to grasp objects without stimulation once the treatment program is completed.   "
158555|NCT01208324|"     The aim of this study is to examine the effects of estrogen and serotonin on cognition,     emotional processing, and brain activation. The investigators will study the effects of acute     tryptophan (TRP) depletion on cognition and mood in healthy menopausal women before and after     estrogen replacement treatment (ERT). Using functional magnetic resonance imaging (fMRI), the     investigators will identify differences in brain activation during memory tasks with and     without TRP depletion and before and after estrogen therapy in order to determine which brain     regions and cognitive functions are affected by each manipulation.   "
158556|NCT01208311|"     The purpose of this study is to determine the amount of fibrosis in the liver of hepatitis C     patients with advanced fibrosis, using endoscopic ultrasound.   "
158557|NCT01208298|"     The primary objective of this study was to evaluate the safety and performance of a cold sore     patch for the treatment of herpes labialis.   "
158528|NCT01208675|"     The present study aims at combining biochemical methods with various types of imaging     techniques to identify the pathophysiology of Alzheimer's disease (AD). The main interest is     to find markers associated with the very early steps in the pathology of this disease. The     investigators shall thus screen for i) molecules in cerebrospinal fluid (CSF) and plasma     specific for AD, and ii) brain imaging markers (e.g. MRI and PET) that correlate to detailed     clinical assessments.      Biomarkers of interest would then be useful to:        1. Enable accurate detection of the disease early on. Such biomarkers need to specifically          reflect the very early pathophysiology of AD and distinguish it from disorders with          similar symptomatology, such as other types of dementia and major depression. The          sensitivity and specificity of these biomarkers in combination with clinical assessment          should be of at least 90%.        2. Enable prediction of the course of events of the disease, such as the disease rate in          individual patients. Biomarkers that can predict the pattern of future symptoms will be          extremely valuable.        3. Allow monitoring of early effects of new disease-modifying therapies (so-called          surrogate biomarkers). Currently clinical therapeutic trials for AD require large          patient groups together with long-term treatment. Both size of the groups and treatment          time will be reduced with the help of surrogate biomarkers.        4. Study the pathogenesis of the disease. Biomarkers can be used to investigate in detail          early alterations in AD patients. For instance, changes in the levels of certain          molecules in CSF together with genetic predisposition could then be correlated to          clinical signs and changes detectable by brain imaging. This can lead to identification          of new therapeutic targets that could easily be monitored in future trials.   "
158529|NCT01208662|"     The drugs, lenalidomide, bortezomib, and dexamethasone, are approved by the FDA. They have     not been approved in the combination for multiple myeloma or any other type of cancer.     Bortezomib is currently approved by the FDA for the treatment of multiple myeloma.     Lenalidomide is approved for use with dexamethasone for patients with multiple myeloma who     have received at least one prior therapy and for the treatment of certain types of     myelodysplastic syndrome (another type of cancer affecting the blood). Dexamethasone is     commonly used, either alone, or in combination with other drugs, to treat multiple myeloma.     Please note that Bortezomib and Lenalidomide are provided to patients participating in this     trial at no charge. Melphalan and cyclophosphamide, the drugs used during stem cell     collection and transplant, are also approved by the FDA. Melphalan is an FDA-approved     chemotherapy for multiple myeloma and is used as a high-dose conditioning treatment prior to     stem cell transplantation. Cyclophosphamide is used, either alone, or in combination with     other drugs, to treat multiple myeloma. These drugs have been used in other multiple myeloma     studies and information from those studies suggests that this combination of therapy may help     to treat newly diagnosed multiple myeloma.      In this research study, we are looking to explore the drug combination, lenalidomide,     bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation     to see what side effects it may have and how well it works for treatment of newly diagnosed     multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of     novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple     myeloma in younger patients. In this study, HDT as compared to conventional dose treatment     would be considered superior if it significantly prolongs progression-free survival by at     least 9 months or more, recognizing that particular subgroups may benefit more compared to     others.   "
170322|NCT00059735|"     The purpose of this study is to determine if E7070 is a safe and effective treatment for     cancer of the kidneys.   "
158530|NCT01208649|"     The primary objective is to test the hypothesis that 24 weeks of treatment with exenatide     will improve the histological acitvity of NASH (steatosis,necroinflammation, ballooning),     summarized in the recently introduced NASH-score in patients with normal, impaired or     diabetic glucose tolerance compared to dietary guidance alone.   "
158531|NCT01208636|"     The purpose of this study is to determine the effect of environmental and genetic influences     on Vitamin D status.   "
158532|NCT01208623|"     Patients with chronic lower limb edema commonly suffered from extremities edema, pain,     varicosities, venous stasis changes, and deep venous thrombosis. A common challenge for     primary care physicians is to determine the cause and find an effective treatment for leg     edema of unclear etiology. The aims of this project are to determine the cause of patients     with chronic lower limb edema with conventional digital venography, the clinical value of     role of 3D rotational venography or combined multidetector (MD)CT angiography and iliac     venography using direct iliac venography for contrast administration via bilateral femoral     catheterization (MDCT angiography/venography) with volume-rendering images supplementary to     2D digital venography in evaluation of patients with chronic lower limb edema.      This project is designed as retrospective cross-sectional study. Between April 2008 and Dec     2009, a total of approximately 300 patients with chronic lower limb edema who had had     bilateral iliac digital venography and surgery at our institution will be reviewed. All     patients underwent surgery by one senior vascular surgeon for lower limb conditions within     one month after the venographic examination. Patients who had incomplete clinical and     surgical records or incomplete images will be excluded. The surgical findings of the     presence, anatomical location, and size of the venous narrowing will assessed and described.     Stenosis was defined as luminal narrowing of 50% or more compared to the prestenotic or     poststenotic lumen.With use of surgical findings as a the standard, the investigators     calculated and compared the diagnostic accuracies, sensitivities, specificities, positive     predict values and negative predict values of 2D digital venography images alone, 3D     rotational venography, and combined MDCT angiography/venography with volume-rendering images     supplementary to 2D digital venography.      With this large series study, the investigators believe that the cause of chronic lower leg     edema in our patients' population will be clarified. The value of additional 3D rotational     venography, and combination MDCT angiography/venography with volume-rendering images will     lead to higher diagnostic performance and may provide a helpful tool for planning surgical     and endovascular treatment, which has not been reported before.   "
158533|NCT01208610|"     The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About     Pregnant Women's Service Quality and Satisfaction   "
158534|NCT01208597|"     Owing to its image resolutions and its convenience in diagnosis, both better than abdominal     ultrasound, transvaginal ultrasound is nowadays widely applied in diagnosing practice in     obstetrics and gynecology. As a result, female examinees who undergo these check-up     procedures have to expose their private parts, instead of their abdomens like the old days.     According to the literature, women who receive transvaginal ultrasound check-ups normally     have anxiety reactions, and worry about pain and discomfort. In clinical practice, when     giving advice to the examinees to go through this check-up, more than often the diagnosis     itself is its sole purpose, and little psychological assistance is offered. Traditional     clinical space and disposal process tend to be designed to serve the purposes of conforming     to the customs of medical staff and to the integrity of human resources and facilities in the     hospital managers' minds, and less frequently tend to take the needs of patients into     consideration. Consequently these patients are forced to enter strange medical environments     and accommodate to the existent medical systems, with physical and psychological discomforts,     to suffer from even more uncomfortable and anxiety-causing check-ups. Current medical service     is required to not only provide a clean environment, but also give attention to creating an     artistic space to increase healthy factors to the environment. The literature points out that     a comfortable and artistic space can eliminate environmental strangeness, and help patients     to soothe their pressures caused by their own and by the environment.   "
158535|NCT01208584|"     The purpose of this study is to use functional MRI (fMRI) and magnetic resonance (MR)     diffusion tensor imaging (DTI) to investigate brain activation and white matter changes in     patients with congenital (birth defect of the spinal column), acute and chronic complete     spinal cord lesions. The findings of this study may provide a basis to better understand the     pathomechanisms underlying the dynamic neurofunctional changes following a spinal cord     lesions in man. This understanding is important for the improvement of existing therapies and     for the development of new therapeutic approaches.   "
158536|NCT01208571|"     The effect of alcohol interventions seems to be related to the intensity of the     interventions. In this study the investigators will assess the effect of a interdisciplinary     booster session in primary care, given to patients who were admitted to hospitals with     alcohol related conditions, and who were given Brief Intervention before discharge. The     booster session is based on a motivational interview.   "
158558|NCT01208285|"     The purpose of this study is to investigate the pharmacokinetics and safety of a single dose     of VX-770 in subjects with moderate hepatic impairment.   "
158537|NCT01208558|"     The main purpose of this 2-year lifestyle experiment for waist loss is twofold:        1. to compare whole grains and no grains as part of a healthy diet,        2. to determine if an 8-week exercise program, led by physiotherapists, is more efficient          than brief counseling and follow-up.      People with abdominal overweight (≥84 cm in women and ≥98 cm in men) and at least one     additional cardiovascular risk factor, (typically hypertension, diabetes type 2 or prior     cardiovascular disease) are randomly assigned to receive Diet A or Diet B, with or without a     structured exercise program at the department of physiotherapy, or to a control group     receiving usual care. Diet A and B both include fruit, vegetables, fish, meat, and low-fat     dairy products, and differ only in that Diet A recommends exchange of cereal grains for more     potatoes, root vegetables, fruit and other carbohydrate-rich foods, while Diet B recommends     exchange of regular cereal grains for whole grains. The primary outcome (most important     follow-up variable) is change in waist circumference during 2 years. Secondary outcome     measures include blood pressure, blood lipids, level of physical activity and, in subjects     with diabetes, glycated hemoglobin and fasting blood sugar.   "
158538|NCT01208545|"     The study hypothesis is that changes in serially obtained nerve conduction study data     obtained every 3-4 weeks in cancer patients receiving chemotherapy can be used to predict the     development of a clinically significant / disabling drug induced neuropathy six and twelve     months following the start of treatment. Patients with breast cancer, colon cancer,     gastroesophageal cancer, and non-Hodgkins lymphoma will be enrolled. Six lower extremity     nerves--three in each leg--will be electrically stimulated and their responses recorded at     three to four week intervals coinciding with patient's scheduled chemotherapy.   "
158539|NCT01208532|"     The aim of this study is to evaluate the reliability and validity of the Korean version of     the European Organization for Research and Treatment of Cancer High-dose Chemotherapy module     (EORTC HDC-29).   "
170397|NCT00067626|"     The purpose of this study is to investigate the effects of Chromium on glucose tolerance and     endothelial function in people at risk for type II diabetes.   "
158540|NCT01208519|"     The study is the WP4 of the EU-funded (7th FW) project SATURN (Impact of Specific Antibiotic     Therapies on the prevalence of hUman host ResistaNt bacteria). A total of 6 surgical and 6     medical wards will participate in the study. Sites of the study are located in 3 countries     (Italy, Serbia, Romania). This WP will compare nosocomial acquisition rates of     methicillin-resistant Staphylococcus aureus (MRSA) and extended-spectrum beta-lactamase     (ESBL)-producing gram-negative bacteria (E.coli, Klebsiella spp. and Proteus spp.) among     different treatment groups and define the temporal relationship between the start of     antibiotic therapy, the acquisition of new colonisation in patients previously not colonised,     and the development of a bacterial infection caused by the same strain isolated in a     screening sample. This goal will be achieved by completing the following primary objectives:        -  To determine the rate of acquisition of target antibiotic-resistant bacteria by 1,000          antibiotic-days according to different classes of antibiotics, duration of therapy and          antibiotic combination (monotherapy versus combination therapy);        -  To determine genotypic relation between colonising and infecting strain in the same          patient and patients' and hospital staff colonising strains (to be performed in          collaboration with WP1 of the SATURN project);        -  To study the virulence and fitness of the isolates (i.e. new colonising strains) causing          subsequent nosocomial infections (to be performed in collaboration with WP1 of SATURN          project);        -  To predict the risk for nosocomial infections due to target bacteria after a single          treatment therapy adjusted by length of hospitalisation and ward colonisation pressure.   "
158541|NCT01208506|"     This trial is conducted in Europe. The aim of this trial is to investigate the safety,     tolerability, pharmacokinetic (the effect of the body on the investigated drug),     pharmacodynamic biomarkers (biomarkers related to anti-IL-21 expected mode of action) and     signs of clinical efficacy of increasing single doses, at 9 i.v. (into the vein) dose levels     in Healthy Subjects , at 3 i.v. dose levels in subjects with rheumatoid arthritis (RA) and at     3 s.c. dose levels in Healthy Subjects.   "
158542|NCT01208493|"     In this randomized study The investigators aim to compare the growth of very-low-birth-weight     (VLBW) infants fed either a high protein or a standard protein preterm infant formula.      Babies will be fed the assigned formula between the time they achieve full enteral feeds and     hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and     compared between groups. Feeding tolerance, protein-energy status and body composition     between the study groups will also be analysed.      After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between     hospital discharge and 3 m corrected age.   "
158543|NCT01208480|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving bevacizumab together with     docetaxel and carboplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel     and carboplatin works in treating women with operable Stage II or stage III breast cancer.   "
158544|NCT01208467|"     This research study is studying prognostic biomarkers in tissue samples from patients with     endometrial cancer. Studying samples of tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer.   "
158545|NCT01208454|"     This phase I trial is studying the side effects and the best dose of vorinostat when given     together with isotretinoin to see how well it works in treating patients with high-risk     refractory or recurrent neuroblastoma. Vorinostat may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Isotretinoin may help vorinostat work     better by making tumor cells more sensitive to the drug. Giving vorinostat together with     isotretinoin may be an effective treatment for neuroblastoma.   "
158546|NCT01208441|"     This phase I trial is studying the side effects and best dose of RO4929097 when given     together with letrozole in treating post-menopausal women with stage II or stage III breast     cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving     RO4929097 together with letrozole may be an effective treatment for breast cancer.   "
158547|NCT01208428|"     Duke University Medical Center in collaboration with Glendale Adventist Medical Center     propose a randomized clinical trial of conventional cognitive behavior therapy (CCBT) vs.     religious cognitive behavior therapy (RCBT) for major depression in medical patients with     chronic disabling illness. Therapists will deliver the treatment in real time over the     Internet and/or by telephone to increase treatment access. This planning grant seeks support     for a two-site study (North Carolina and California) that consists of two phases. In Phase I     (Rounsaville 1a) the investigators will conduct an open trial of 30 patients to assess     subject recruitment, refine RCBT and CCBT manuals and protocol, assess compliance with     treatment, acceptability of treatment and delivery system (online vs. telephone), and allow     therapists gain experience with delivery system and RCBT.      In Phase II (Rounsaville 1b) the investigators will conduct a randomized proof of concept     comparison of CCBT vs. RCBT that will demonstrate feasibility and confirm the expected     clinically meaningful difference for a definitive R01 application. In Phase II, 70 religious     patients ages 18-85 with a new episode of major depression (MINI), scores of 16-35 on the     Beck Depression Inventory (BDI), and at least one chronic disabling medical illness will be     randomized to either CCBT or RCBT. The trial will consist of ten 50 min sessions administered     by master's level therapists and delivered over 12 weeks. The primary endpoint will be BDI     score at baseline, 4, 8, 12, and 24-week follow-up. Christian, Jewish, Hindu, Buddhist, and     Muslim versions of the RCBT manual will be developed, and CBT experts in each of these     traditions will supervise therapists delivering the intervention to patients from these faith     traditions.      The purpose of this study is to determine feasibility and effect sizes for a future, fully     powered treatment study. The importance is that results will be relevant to therapists well     beyond those who explicitly practice pastoral counseling, extending to many secular     therapists as well. If 65% of Americans indicate that religion is an important part of daily     life and the vast majority of chronically ill medical patients wish to include it in their     therapy, then all therapists (whether they have explicit training in pastoral counseling or     not) are likely to encounter patients in which this approach would be applicable.   "
158548|NCT01208415|"     The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the     safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in     combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the     treatment of aorto-iliac and iliac aneurysms.   "
158549|NCT01208402|"     The purpose of this study is to find out if Esmolol is a safe and effective alternative     treatment compared to standard treatment using a long acting beta blocker drug, in     controlling abnormal heart rate before, during and immediately after surgery.   "
158551|NCT01208376|"     Little is known about the clinical significance of chronic alanine aminotransferase (ALT)     elevation in HIV-infected patients without hepatitis B and C coinfection. Study aim is first     to evaluate the prevalence of liver fibrosis and cirrhosis in HIV-infected patients with     chronic ALT elevation and no chronic viral hepatitis using non-invasive diagnostic tests and     second to find associated factors with significant fibrosis and cirrhosis. In a second     longitudinal part we intend to assess fibrosis progression within 1 and 3 years.   "
158552|NCT01208363|"     Rationale: Iron deficiency and zinc deficiency, are of public health significance in     sub-Saharan Africa. An estimated 50% of children (5-14 years) in developing countries suffer     from anaemia, half of which is estimated iron deficiency anaemia. Interventions have been     designed and implemented over the years towards solving hunger and anaemia especially among     school age children. One of such interventions is School Feeding Programme (SFP) which is     common in both developing and industrialized countries. SFP has been part of the Ghanaian     educational system for well over 40 years, albeit on small scale. The main stay of the     programme that makes it distinguishable from other past and existing school feeding     programmes is its reliance on locally produced and available foods, such as cowpeas. Legume     staples like cowpea have been identified to be important sources of protein and non-heme iron     to rural populations of developing countries like Ghana. The problem however is the low     bioavailability of these micronutrients from these legumes.      Objective: To assess the efficacy of iron fortified cowpea based meal (Tubani) in improving     iron status of primary school children in rural northern Ghana Study design: A randomized     double blind parallel design will be conducted. One group will receive iron fortified Tubani     with NaFeEDTA and the other group will receive unfortified Tubani.      Study population: Two hundred and forty apparently healthy pupils in lower primary school     will participate. The participating schools have a school feeding programme currently in     operation.      Intervention (if applicable): Children will be fed Tubani containing 10mg of fortification     iron (in the form of NaFeEDTA) three times in a week for six months. Weight, height and blood     samples will be measured at baseline and after six months of intervention. Participants will     be treated against intestinal parasites before start of intervention and halfway through the     intervention.      Main study parameters/endpoints: The main study endpoint is iron-deficiency anaemia (IDA).     IDA will be defined as concurrent anaemia and iron deficiency. Whole blood will be collected     for the analysis of Hb, serum ferritin (SF), serum transferring receptor (sTfR) and     C-reactive protein (CRP). Anemia will be defined as a hemoglobin concentration <115 g/L, and     iron deficiency will be defined as an SF concentration <12 µg/L.      Venipunctures occasionally lead to bruises or small local inflammation which usually     disappear within one week. To minimize this risk, blood collection will be performed by a     trained and experienced phlebotomists. Written informed consent will be obtained from all     subjects.   "
158553|NCT01208350|"     This is a 3-arm pilot randomized controlled trial to evaluate the effectiveness of two novel     ways of structuring financial incentives to motivate and sustain long-term weight loss. The     study will recruit eligible employees at Children's Hospital of Philadelphia (CHOP) to     participate in a 6-month weight loss program and an additional 3-month follow-up period. The     primary outcome measure in this randomized control trial will be pounds of weight lost     between baseline and 6 months. The goal of this study is to evaluate whether a novel     financial incentive program delivered through a workplace can effectively encourage sustained     weight loss among obese employees.      The study hypotheses are 1) mean weight loss will be greater in all the intervention groups     compared to the control group by the end of the 24-week intervention period; and 2)     individuals in the intervention groups will have a lower mean weight at the end of the     12-week follow-up period than individuals in the control group.   "
158554|NCT01208337|"     This open-label clinical trial will evaluate the safety and efficacy of Alemtuzumab (Campath,     Bayer Corp., Pittsburgh) in children (0-17) and adults (18-25) receiving intestinal     transplant. Seventy-five subjects receiving primary or repeat intestine transplantation will     be enrolled. Primary endpoints include the incidence and severity of biopsy-proven acute     cellular rejection, the incidence of freedom from steroids at 5 years, and the incidence of     subjects with steroid-free Tacrolimus at whole blood concentrations < 10 ng/ml. Secondary     endpoints include a) incidence and severity of opportunistic infections (CMV and EBV),     post-transplant lymphoproliferative disorder (PTLD), and chronic rejection b) use of     non-immunosuppressive co-medications, c) time to repopulation of all lymphocyte subsets, d)     longitudinal characterization of donor-specific alloreactivity in mixed lymphocyte responses     (MLR), to identify the time at which it decreases to a level less than third-party-specific     alloreactivity e) longitudinal expression (mRNA) of genes, to identify rejection- and     non-rejection-specific genes and f) characterization of whole genome mutations, which show     differences in parent-to-child transmission between rejectors and non-rejectors. This will     identify rejection- and non-rejection-specific genes bearing genetic variants, which might     impact on gene function, and complement candidate gene identification efforts based on SNP     transmission.   "
158789|NCT01205269|"     The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in     COPD patients.   "
158562|NCT01208233|"     The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following     multiple dose administration to subjects with ischemic stroke. The study will also evaluate     the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following     90 days of therapy. The study will also explore the relationship between PF-03049423     concentration and blood pressure.   "
158563|NCT01208220|"     Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a     device which by themselves are effective for the treatment of wounds.      You are being asked to take part in this study because you have a wound on your body which     has not responded to standard treatments.      The researchers will be studying whether the combination of two treatments will make wounds     heal faster. For those in study, the investigators will treat them with a vacuum device on     their wound. Also, some of the people in the study will receive a special ointment and     researchers will use special tests to determine if the two treatments together are working     better than just one treatment alone.   "
158564|NCT01208207|"     The purpose of the study is to evaluate the efficacy and tolerability of two doses of     etoricoxib compared to naproxen in the treatment of ankylosing spondylitis (AS). The primary     objectives are to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment     with etoricoxib 90 mg or 60 mg compared to naproxen; and to evaluate the improvement in     Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg compared with     etoricoxib 60 mg. Additionally the added benefit of increasing the dose of etoricoxib from 60     mg to 90 mg will be assessed in the second part of the study. The primary hypothesis is that     the improvement in Spinal Pain Intensity visual analog scale (VAS) as measured by the     time-weighted average (TWA) change from baseline over 6 weeks of treatment in Part I for     etoricoxib 90 mg or 60 mg once daily is not inferior to naproxen 1000 mg.   "
158565|NCT01208194|"     This is a phase 2, randomized, double-blind, multi-center clinical study to evaluate efficacy     and safety of a maintenance therapy with the immunomodulator MGN1703 compared to placebo     control. The study will be conducted in patients with advanced colorectal carcinoma (AJCC     Stage IV) with disease control after first-line standard chemotherapy regimens.   "
158566|NCT01208181|"     This is a 2-part (6 weeks duration for each part), randomized, double-blind,     placebo-controlled study in participants with rheumatoid arthritis. The hypothesis is that     etoricoxib (60 mg and 90 mg) administration will demonstrate superior efficacy compared to     placebo after 6 weeks of treatment, as measured by the greater mean improvement from baseline     in the Disease Activity Score C-Reactive Protein (DAS-28 CRP), and by the greater mean     improvement in Patient Global Assessment of Pain (PGAP) from baseline over 6 weeks of     treatment. Additionally, the added benefit of increasing the dose of etoricoxib from 60 mg to     90 mg will be assessed in the second part of the study.   "
158567|NCT01208168|"     The objectives of this study are to assess the safety of NAB001 for topical treatment of mild     to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of     NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.   "
158568|NCT01208155|"     Study in healthy males to assess bioavailability of 4 different fostamatinib tablets   "
158569|NCT01208142|"     The purpose of this study is to examine the change in ankle plantar flexion while walking,     following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as     Toe Walkers.      For twelve weeks, patients will either receive the standard treatment or the same standard     treatment and the Dynaslint worn at night.   "
158570|NCT01208129|"     The objectives of this study are to assess the safety of NAB001 for topical treatment of mild     to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of     NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.   "
158571|NCT01208116|"     The purpose of this study is to determine whether non-invasive atherosclerotic measurements     (baPWV, IMT, FMD, CACS, ABI) are valuable predictors for cardiovascular events in elderly. At     inception, routine physical examination and non-invasive atherosclerotic measurements will     conducted on all participants. Then they will be followed prospectively for at least 2 years.     All cardiovascular and other health events will be recorded.   "
158572|NCT01208103|"     The goal of this clinical research study is to learn if the combination of capecitabine,     oxaliplatin, and bevacizumab can help to control cancer of the small bowel or ampulla of     Vater. The safety of this drug combination will also be studied.   "
158573|NCT01208090|"     This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in     patients with moderate-to-severe chronic plaque psoriasis.   "
158574|NCT01208077|"     This multinational registry (3 USA, 2 European centers) will capture in the ED continuous non     invasive hemodynamic monitoring (using Nexfin finger cuff technology) of patients presenting     with acute heart failure, stroke syndromes and systemic infection. Patients will be observed     after their Emergency Department (ED) disposition to determine clinical outcomes (length of     stay in the hospital, the development of any organ dysfunction, mortality and need for     unscheduled medical care within the ensuing 30 days). It is anticipated that specific ED     hemodynamic profiles will be predictive of better clinical outcomes than others. This     information will provide the outcome data needed to design future therapeutic trials that     will evaluate the effect of ED hemodynamic manipulations on overall patient management and     outcomes.   "
158575|NCT01208064|"     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known     whether pazopanib hydrochloride is more effective than a placebo in treating patients with     non-small cell lung cancer that has not progressed after first-line chemotherapy.      PURPOSE: This randomized phase II/III trial is studying how well giving pazopanib     hydrochloride works and compares it with giving a placebo in treating patients with non-small     cell lung cancer who have received first-line chemotherapy.   "
158576|NCT01208051|"     This partially randomized phase I/II trial studies the side effects and best dose of     cediranib maleate when given together with or without lenalidomide and to see how well they     work in treating patients with thyroid cancer. Cediranib maleate may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the     growth of thyroid cancer by blocking blood flow to the tumor. It is not yet known whether     cediranib maleate is more effective when given together with lenalidomide in treating thyroid     cancer.   "
158577|NCT01208038|"     A woman's ovaries produce the hormone testosterone during her reproductive life but     testosterone levels decline with age or when the ovaries are removed. Testosterone has been     associated with sexual desire in both men and women. Low testosterone is also believed to     cause symptoms of low energy. Thus testosterone is increasingly used in hormone replacement     regimens to restore libido and energy in postmenopausal women.      In the past testosterone has been administered orally or via subcutaneous implants. Recently     testosterone patches have been licensed for treating low libido in postmenopausal women. The     testosterone patches deliver a dose of testosterone equivalent to the levels produced by the     ovary during a woman's early reproductive years.      Oral testosterone can lead to changes to insulin and cholesterol levels which increase the     risk of heart disease. On the contrary, testosterone patches may reduce or avoid this risk.     To date, trials have predominantly focused on safety data in terms of side effects and basic     blood tests. Reviews of the safety of testosterone replacement have emphasised the need for     improved safety data, especially in terms of cardiovascular risk.      The purpose of this study is to examine the effect of the testosterone patch, in addition to     hormone replacement therapy (HRT), on blood vessel walls, insulin levels and sexual desire.      The investigators hypothesis that transdermal testosterone, in addition to HRT, will have no     adverse effects on blood vessel walls and insulin levels and that transdermal testosterone     significantly improves sexuality and psychological well-being in postmenopausal women.      Trial design:      The investigators aim to recruit 20 postmenopausal women to wear the testosterone patch for 3     months in addition to their usual hormone replacement therapy.      There will be 3 study visits - a pre study visit, week 6 and week 12. At each visit the     following procedures will be performed:        -  Medical history and physical examination        -  Blood sample - for hormone levels, lipids and insulin levels        -  Blood vessel stiffness measurements This will be performed using a small ultrasound          device at the wrist with blood pressure measured every 5 minutes.        -  Endothelial function (function of your arterial wall) is measured using a blood pressure          cuff on each arm and finger probes on one finger of each hand. The blood pressure cuff          is inflated for 5 minutes and is then deflated quickly. The finger probes will record          the readings throughout this study.        -  Sexual satisfaction questionnaire   "
158617|NCT01207505|"     Psychoeducation has been the only group treatment developed for bipolar disorder thus far.     Deficits in emotion regulation, a core impairment among patients with bipolar disorder, are     not directly addressed in this treatment. The objective of this study is to develop a group     treatment for bipolar disorder that focuses on emotion regulation strategies (Enhancing     Emotion Regulation; EER). This study will examine the efficacy of this treatment using an     open trial design. It is hypothesized that patients who receive EER will show a reduction in     mood symptoms and improvement in well-being. Reductions in emotion regulation difficulties     will predict improvements.   "
159261|NCT01199068|"     The primary objectives of this study are to evaluate the safety and tolerability of CS-7017     administered orally twice a day in combination with erlotinib, and to assess the     pharmacokinetics of CS-7017 in combination with erlotinib.   "
158578|NCT01208025|"     The possibility of the identification of the risk of rupture of a carotid plaque will have     tremendous impact in clinical decision making. Firstly, in symptomatic patients with a 30-69%     stenosis, who are currently not operated upon according to the current guidelines,     identification of the risk of rupture plaque could identify patients who have a high risk of     recurrent stroke, and would benefit of carotid intervention, such as endarterectomy or stent     placement. This could potentially prevent a substantial number of strokes. Secondly, in all     symptomatic patients with a 70-99% stenosis carotid intervention should be considered,     according to the guidelines. However, only one out of six patients with a 70-99% stenosis     benefits from a carotid intervention. Identification of patients with a high risk of a     recurrent stroke would reduce the number of unnecessary interventions substantially.      The main objective is to show whether imaging characteristics assessed at baseline can     predict clinical events in patients with a 30-69 % symptomatic carotid stenosis.   "
158579|NCT01208012|"     The trial is a phase IV clinical trial investigating the impact of Liraglutide on endothelial     function and microvascular blood flow in 44 patients with type 2 diabetes mellitus aged 30-65     and HbA1c ranging from ≥ 5.5% ≤ 7.0%. The patients will be randomized into two study arms,     one arm will be treated with Metformin monotherapy, the second arm will be treated with     Metformin and Liraglutide at an increasing dose (0.6 mg/day to 1.8 mg/day.)   "
158580|NCT01207999|"     The aim of the study is to assess the distribution of the most frequent types of human     papillomavirus in African women diagnosed with invasive cervical cancer.   "
158581|NCT01207986|"     Early Lung Cancer diagnosis in a HIV-infected population with an important smoking history     with low-dose CT: a pilot study: the HIV-CHEST study Objectives The main objective of this     study is to evaluate the prevalence of lung cancers detected by low-dose computed tomography     (CT) in a HIV-infected population with an important smoking history. Other objectives are (1)     the evaluation of the types of lung cancers in this population, as well as (2) the staging of     non small cell lung cancers, (3) the description of risk factors for all lung cancers, if     they are numerous enough, and (4) the number of complications of diagnosis procedures during     the study.   "
158582|NCT01207973|"     The objective of the study is to investigate the safety and tolerability of BI 113823 in male     and female patients with osteoarthritis, following oral administration of BI 113823 with     repeated rising doses.   "
158583|NCT01207960|"     The purpose of this study is to find out whether Eye Movement Desensitization and     Reprocessing (EMDR) is effective in the treatment of patients with dental phobia.   "
158584|NCT01207947|"     Main object is to investigate the safety profile of Levitra in combination use with     alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.      In the initial combination date and the first and second observation after initial     combination date, number of tablets prescribed, dose of tablets and number of tablets taken     until follow-up visit will be investigated. The efficacy and tolerability will be evaluated     at 2 months after initial combination date.   "
158585|NCT01207934|"     Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not     known whether it improves insulin action in persons who are not leptin deficient. The purpose     of the present study was to determine whether leptin therapy has effects on insulin action in     obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial     was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to     treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.   "
158586|NCT01207921|"     The purpose of this study to evaluate the feasibility of lenalidomide maintenance therapy in     patients with relapsed Hodgkin lymphoma after autologous transplant   "
158587|NCT01207908|"     The purpose of this study is to determine whether IGF-1 therapy improves or preserves muscle     function in Duchenne Muscular Dystrophy (DMD).   "
158588|NCT01207895|"     The purpose of this study is to determine if positron emission tomography (PET) imaging with     an imaging agent called 18F-fluorodeoxythymidine([18F]-FLT) will allow investigators to     measure how well tumor(s) respond to treatment without taking a tissue sample (biopsy).     Additionally, the investigators want to determine if it is possible to predict how well     tumor(s) might respond to treatment with [18F]-FLT PET imaging.   "
158589|NCT01207869|"     Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth     arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely     premature infant with severe BPD to establish whether intratracheal instillation of umbilical     cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe BPD.   "
158590|NCT01207856|"     Despite the need for cognitive rehabilitation, there is a paucity of well-designed research     studies to investigate treatment approaches or their effectiveness in MS. Most of published     studies suffer from significant methodological flaws including small sample size, short     follow-up periods, and lack of specific outcome criteria to determine improvement. O'Brien et     al. (2008) recently reviewed 16 studies of cognitive rehabilitation designed to persons with     MS and found only 4 class I studies and only one class I study of rehabilitation of attention     deficits. Methodologically rigorous research is needed to confirm the preliminary results     reported by these studies and determine the effectiveness and efficacy of cognitive     rehabilitation interventions in attention deficits in MS. O'Brien et al. listed limitations     found in previous studies that must be addressed in future studies. The present study was     designed according to these recommendations. It is a randomized, controlled study, in     parallel groups, evaluator blinded.      Number of participants: 25 RRMS patients in the active group, 25 RRMS patients in the control     group and 25 healthy subjects.      The protocol will be proposed to RRMS patients AFFILIATED TO FRENCH SOCIAL SECURITY referred     to the investigators center by practicing neurologists and fulfilling the inclusion criteria     for screening.      Patients will be randomised between two groups. The active group (25 patients) will be     treated by rehabilitation. Individual rehabilitation procedures will be focused on attention,     executive functions and IPS. The program will be tailored to each patient cognitive status     depending on the impairments identified during the initial assessment while maintaining a     systematic work on attention and executive functions. A total of 50 sessions lasting one hour     at a rate of 3 sessions per week for a total period of 4 months will be proposed. Patients     randomized in the other group will participate to group session every week without specific     cognitive rehabilitation. 25 healthy control subjects (group C), matched to patients for     education, gender and age with patients of groups A/B will have the same evaluation     procedures than patients.      Evaluation will be performed at baseline, after 4 months (end of treatment period) and after     8 months. Evaluation will include clinical testing, cognitive battery (paper/pencil and     computer tests), cognitive ecological evaluation (Computer test of attention in a virtual     reality environment and driving test on a driving simulator), questionnaires about daily life     and MRI (fMRI and MRI). All patients and healthy subjects will undergo the fMRI protocol     using a paradigm previously published by the investigators group (Bonnet et al., 2009):     Go/No-go paradigm with increasing difficulty during four successive conditions (the Tonic     Alertness task, Go/No-go (IG), reversal Go/No-go (RG), and complex Go/No-go (CG). In a     previous study the investigators observed compensatory activation in MS patients as compared     to healthy controls for the three first conditions and a saturation of compensatory processes     for the more complex. In the present study, the investigators hypothesize that a similar     pattern will occur at baseline and that cognitive rehabilitation will improve brain     compensation at the fourth level of complexity.   "
158614|NCT01207544|"     Children with developmental coordination disorder (DCD) often have poor postural control and     motor skills that affect their activities of daily living and participation in school     activities. The aim of this randomized controlled trial is to compare the effects of fitball     training versus task-oriented motor training for children with DCD.   "
158591|NCT01207843|"     Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy     for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans,     but there is no standardized CT protocol for the diagnosis and follow-up of hepatic     candidiasis.      The investigators compared the size of the fungal lesions in the chest and abdomen CT. The     current analysis aimed to increase the value of CT for the diagnosis and the follow-up of     hepatic candidiasis in daily routine.   "
158592|NCT01207830|"     The purpose of this study is to provide initial clinical data to support the feasibility of     use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in     morbidly obese subjects   "
158593|NCT01207817|"     The purpose of this study is to determine the effects of varying luminescent levels on the     pupillary response.   "
158594|NCT01207804|"     The purpose of the study is to provide initial clinical data to support the feasibility of     use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in     morbidly obese patients.   "
158618|NCT01207492|"     Nilotinib is a drug that is used to treat a form of a blood cancer called leukemia. Nilotinib     works by blocking the action of a protein that might be important for the growth of pigmented     villonodular synovitis (PVNS). In this research study the investigators are testing whether     nilotinib can stop the growth of PVNS or improve the symptoms experienced from PVNS.   "
158595|NCT01207791|"     Misuse of drugs and alcohol has a tremendous impact on individual health and on society, in     terms of both human suffering and economic cost. Most substance abusers never seek specialty     addiction treatment, but a large percentage of them receives some form of medical care,     frequently in emergency room settings. There is considerable evidence showing that Screening,     Brief Intervention, Referral, and Treatment (SBIRT) interventions in medical settings result     in decreased drinking and alcohol-related problems among those with alcohol abuse or     dependence. However, there are few studies using these models focusing on drug users.     Although drug users are seen in large numbers in emergency departments, there have been no     randomized controlled trials of SBIRT models for drug users presenting in Emergency     Departments (EDs).      This study is designed to assess the effects of Assessment, Referral, and a Brief     Intervention on substance use of individuals screening positive for drug use during a medical     ED visit. The Southwest Node of the NIDA Clinical Trials Network, located at UNM CASAA, is     taking the lead on this study. Six sites across the country will participate in this study,     including the ED of UNM Hospital. A total of 1285 ED patients who screen positive for current     drug use problems will be randomly assigned to receive 1) minimal screening only, 2)     assessment of substance use and referral to treatment, or 3) assessment and referral combined     with a 30-minute counseling session (Brief Intervention) and two follow-up telephone     counseling sessions. Outcomes will be assessed at 3, 6, and 12 months after the ED visit. We     hypothesize that those who receive the Brief Intervention will have the least drug use at     follow-up, that those who receive minimal screening only (the usual current practice) will     have the most drug use, and that those receiving assessment and referral without the Brief     intervention will have intermediate outcomes.   "
158596|NCT01207778|"     Approximately 60,000 premature infants are born each year who weigh less than 1,500     grams,many of whom sustain brain damage because of their prematurity. This study is designed     to evaluate the long-term developmental effects of one promising neuroprotective     treatment,erythropoietin (Epo), when given in the neonatal period. Using detailed     neurodevelopmental testing and state-of-the-art brain imaging, we hope to determine whether     this is an effective treatment to prevent brain injury associated with prematurity, and to     lay the groundwork for further studies to improve the developmental outcome of infants     delivered prematurely.   "
158597|NCT01207765|"     The study involves the use of a targeted form of radiation, in addition to standard high dose     chemotherapy and stem cell transplant for multiple myeloma. The use of targeted radiation is     designed to kill more multiple myeloma cells while avoiding the side effects of standard     radiation. This type of targeted radiation (also known as radioimmunotherapy) has been     approved by the Food and Drug Administration (FDA) for the treatment of a related disease,     lymphoma under the trade name, Zevalin©. Zevalin© has been added to high dose chemotherapy     and stem cell transplants for patients with lymphoma and is now being studied in this     clinical trial for patients with multiple myeloma. This trial is only available at Tufts     Medical Center.      The proposed clinical trial will test whether CD20-targeted radio-immunotherapy can be safe     and effective when integrated into a standard regimen of myeloablative chemotherapy and     autologous stem cell rescue in patients with measurable disease prior to high dose     chemotherapy and autologous stem cell transplant for multiple myeloma.   "
158598|NCT01207752|"     The aim of this study will be to determine the efficacy of this novel, lipid-containing     artificial tear on the signs and symptoms of meibomian gland disease.   "
158599|NCT01207739|"     The purpose of the study is to establish whether prolonged antibiotic treatment of patients     diagnosed with proven or presumed PLD (as endorsed by the international ILADS guidelines)     leads to better patient outcome than short-term treatment as endorsed by the Dutch CBO     guidelines.   "
158600|NCT01207726|"     This study combines the deoxyribonucleic acid (DNA) methyltransferase inhibitor,     5-azacitidine (5-AZA), with an orally bioavailable histone deacetylase inhibitor, entinostat     (SNDX-275), for the adjuvant treatment of patients with resected stage I non-small cell lung     cancer (NCSLC).   "
158601|NCT01207713|"     To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing     surgical technique in hydroxyapatite orbital implants   "
158602|NCT01207700|"     This is a randomized, open trial comparing post discharge interventions by community health     workers (CHW) to standard care in acute coronary syndrome (ACS) patients.      This trial will be conducted in 10 hospitals in India/different parts(both secondary and     tertiary care). A total of 800 patients will be recruited, with equal allocation to SPREAD     interventions and control groups (usual care)   "
158603|NCT01207687|"     People who have neurofibromatosis type 2 (NF2) can have tumors that grow on the auditory     nerves and cause hearing loss. These tumors are called vestibular schwannomas (VSs), or     acoustic neuromas. People with NF2 can also get schwannomas in other parts of their body, as     well as tumors called meningiomas and ependymomas. Because VSs can cause hearing loss, many     people with NF2 will have treatment to preserve their hearing. This treatment usually     involves surgery. Because surgery has risks and is not able to help everyone with VSs, other     methods of treatment are being explored. One area of exploration is looking to see if there     is a drug that can be taken that might prevent the VSs from growing larger and causing     hearing loss or brainstem compression. This study is exploring whether a drug that is     approved by the FDA and is currently used to treat other tumors might also work to treat VSs.     Based on people who have taken this drug to treat VSs already, there is some reason to think     that it might be helpful to certain people with NF2. People enrolled in this study will     receive the drug one time every three weeks for one year by infusion. This study will follow     subjects over the course of the year that the person is taking the drug and for six months     after the drug is stopped. This study is recruiting people who have NF2 and are currently     having symptoms of tinnitus, dizziness, and/or hearing loss from their VSs. If you have NF2     and are currently having symptoms caused by your VSs, you may be eligible to participate.   "
158604|NCT01207674|"     This study is divided into two stages. The first stage is a transversal study and corresponds     to the recruitment of participants, which will last about two years. Three groups of gamblers     will be constituted : Non-problematic gamblers (NPG), Problematic gamblers Not in Care (PGNC)     and Problematic gamblers in Care (PGC).The second stage is a prospective 5-year follow-up     study of the cohort (only the initial NPG and PGNC groups are concerned by the follow-up     study), that consists on an annual follow-up evaluation. The main objective of the first     stage of the study is to compare the characteristics of the three groups of gamblers on some     socio-demographic and clinical data. These comparisons will allow us to identify, among all     data, those that will be most likely to explain the evolution of the practice of gambling     (appearance or resolution of a gambling problem), and recourse to specific care. These such     isolated data will be tested in the second stage of the study, in order to determine those     that are predictive factors of three steps of the gambling course of some gamblers :     evolution of a controlled gambling practice into a problematic gambling practice, resolution     of the problematic gambling practice without intervention of care, and first recourse to     specific care.   "
158605|NCT01207661|"     Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in     terms of social and economic, are palliative and do not contemplate healing by regenerative     therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded in     vitro and may regenerate several damaged or injured tissues. In addition its has demonstrated     that MSC are able to modulate immune responses and to control inflammation through its action     on T lymphocytes. Preliminary studies in animal models, including one carried out in an     equine by the investigators research group, confirms feasibility, safety and efficacy     evidence proposed treatment protocol.This study is designed to evaluate therapeutic potential     and safety of mesenchymal stem cells in improvement of osteoarthritis clinical     manifestations.This study is designed to evaluate therapeutic potential and safety of     mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.   "
158606|NCT01207648|"     The aim of this retrospective study is to review and describe safety, tolerability and     efficacy of Rebif® (subcutaneous interferon [IFN]-beta-1a) in children and adolescents, using     information already recorded in medical records. The study duration is 13 July 2010 (first     data collected) to 13 July 2011 (last data collected). In this study, Data of the subjects     evaluated between 1997 and 2009 was observed.   "
158607|NCT01207635|"     The goal of this study is to evaluate antiproliferative effects of Arimidex in ductal lavage     fluids of Breast Cancer patients.      Breast cancer is the leading cause of cancer incidence and the second leading cause of cancer     mortality in women. Breast duct fluid provide biomarkers to aid in risk assessment of     developing breast cancer.   "
158608|NCT01207622|"     The primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in     the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder (ADHD)     with comorbid Substance Use Disorder (SUD). The secondary objective of the study is to     determine the efficacy of ATMX in preventing SUD relapse. As previous pre-clinical work has     demonstrated that ATMX has led to significant improvement in ADHD in children and lacks abuse     liability, the investigators hypothesize that ATMX will be efficacious in treating ADHD in     adolescents and young adults with SUD, and that ATMX will also be efficacious in preventing     SUD relapse.   "
158609|NCT01207609|"     The purpose of this study is to collect data prospectively on the safety and efficacy of the     Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity.      The 95% confidence interval for average percentage of weight loss and body mass index will be     computed at 6 months, one year and then annually. Analysis of comorbid conditions changes,     quality of life and adverse events will be performed. With 50 subjects in the study, limited     power is expected and no formal hypothesis testing will be performed.   "
158610|NCT01207596|"     The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with     neuropathic pain.   "
158611|NCT01207583|"     This study is planned to monitor the local and/or systemic reactions and compatibility of     PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with     the observational nature of this protocol, Prevenar will be administered as standard of care.      The aim of this study is to estimate the incidence of febrile reactions more than 38.0     degrees Celsius, specifically (≥38 to < 39 degrees C; > 39 to < 40 degrees C and > 40 degrees     C, and the frequency of other local or systemic reactions following vaccination with Prevenar     (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine     daily use in the Russian Federation.   "
158612|NCT01207570|"     Children with developmental disabilities often sustain decreased range of motion in their     extremities. The decrease in flexibility may be due to neuromuscular disorders such as     spasticity or dystonia. Other causes may be imbalance in muscle strength surrounding a joint,     leading to inappropriate habitual posture. Over time, muscle contracture may result for those     muscle groups that are placed in a shortened position for an extended period of time. The     most common site of muscle contractures among these children are gastrocnemius/soleus (lower     limbs), and latissimus dorsi muscles (upper limbs). Muscle contractures can lead to further     decline in functional abilities. Therefore, it is important to identify effective     intervention strategies to enhance or maintain muscle flexibility in children with     developmental dysfunctions.      Commercially available endermotherapy device has been used to soften scar tissue following     burn injuries. The mechanical stimulation applied may also have beneficial effects on     relaxing the muscle tissue. The overall aim of the proposed study is to determine whether     endermotherapy treatment has immediate effect in improving joint range of motion among     children with developmental disabilities.      The research hypothesis is that children in the endermotherapy group will have significantly     more gain in ankle passive range of motion than those in the control group.   "
158613|NCT01207557|"     The purpose of this study is to determine whether, among healthcare personnel who are     undecided about whether to receive influenza vaccine, does use of the OIDA increase or     decrease their confidence in their decision to be immunized? Furthermore, does the use of the     OIDA affect the intent of the healthcare personnel to be immunized or not immunized?   "
158798|NCT01205152|"     This clinical trial studies the long term safety and efficacy of asfotase alfa in infants and     young children with infantile onset HPP who completed the ENB-002-08 study.      Partial funding for this study was provided by the Office of Orphan Product Development     (OOPD).   "
158615|NCT01207531|"     Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and     treatment directly affect the survival rate. MiRNA is a post-transcriptional small RNA which     regulate mRNA expression. The present study was designed to screen several miRNA by     microarray which evaluate the sepsis prognosis in order to be a new target for the treatment     of sepsis.   "
158616|NCT01207518|"     During the 2010-2011 and the 2011-2012 seasonal influenza immunization campaigns, we will     recruit a minimum of 46 healthcare organizations to either conduct their campaigns as usual     or to use the Successful Influenza Immunization Campaigns for Healthcare Personnel: A Guide     for Campaign Planners and a web-based grab-and-go Tool Kit. At the end of the campaign season     we will evaluate the impact of the Guide and web-based tools and assess whether there were     changes in immunization rates within each organization and/or if there were significant     changes in the management of the campaigns across organizations.      Following completion of the study, we will work with partner organizations to make these     tools available to all Canadian healthcare organizations.   "
158619|NCT01207479|"     This is a non-randomized, open-label, multi-center clinical study to be conducted at     approximately 5 investigative sites in the US that have expertise in the healthcare     management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current     moldable users while the remaining users can be non-moldable users if moldable users can not     be enrolled.   "
158620|NCT01207466|"     The purpose of this trial is to compare the performance of two contact lenses for contact     lens wearers with astigmatism.   "
158621|NCT01207453|"     The purpose of this study is to determine whether milnacipran reduces widespread, non-joint     pain in patients with rheumatoid arthritis (RA). The investigators will conduct a     double-blind randomized crossover trial in subjects with RA to test the hypothesis that     milnacipran improves widespread, non-joint pain. The investigators will also use data from     the trial to determine whether response to milnacipran is associated with pain-modulating     mechanisms from the central nervous system. The investigators hypothesize that response to     milnacipran will be greater among patients with impaired central pain mechanisms than among     patients with intact central pain modulating mechanisms.   "
158622|NCT01207440|"     The purpose of this study is to determine the efficacy of ponatinib in patients with chronic     myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or     with Ph positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or     intolerant to either dasatinib or nilotinib, or have the T315I mutation.   "
158623|NCT01207427|"     Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and     reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI     tract. The most common symptoms associated with the effects of opioids are constipation and     nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of     long-term opioid therapy.      The primary objective of this study was to compare ADL5945, a MOR antagonist, with placebo in     the treatment of opioid-induced constipation (OIC) in adults taking long-term opioid therapy     for chronic noncancer pain.   "
158624|NCT01207414|"     Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult     subjects with schizophrenia who require a change in their current antipsychotic treatment of     risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or     safety/tolerability reasons.   "
158625|NCT01207401|"     The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine     administered prior to IUD insertion reduces insertion pain. The hypothesis is that women     receiving paracervical analgesia will experience less pain during IUD insertion than those     who do not receive such analgesia.   "
158626|NCT01207388|"     The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab     (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal     residual disease.   "
158627|NCT01207375|"     The current study is a double-blind, placebo-control randomized clinical trial examining the     efficacy of memory retraining in Traumatic Brain Injury (TBI). Impairment in higher level     cognitive processing, such as new learning and memory, is one of the most common deficits in     individuals with TBI and such deficits have been shown to exert significant negative impact     on multiple aspects of everyday life, including occupational and social functioning. Despite     these findings, few studies have attempted to treat these cognitive deficits in order to     improve the everyday functioning of individuals with TBI. The current proposal will evaluate     (a)the efficacy of this treatment protocol within a TBI population,(b) the impact of the     treatment on everyday functioning, (c) the long term efficacy of the treatment and (c) the     utility of booster sessions in facilitating long-term treatment effects. The investigators     will randomly assign individuals with TBI, with documented impairment in new learning     abilities, to a memory retraining group or a placebo control group. Both groups will undergo     baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional     neuropsychological battery and (2) an assessment of global functioning examining the impact     of the treatment on daily activities. This design will allow us to evaluate the efficacy of     this particular memory retraining technique in a TBI population through the assessment of     cognitive function via a standard evaluation. In addition, the investigators will be able to     draw conclusions regarding the impact of this particular memory remediation program on     everyday life from questionnaires completed by the participant and a significant other.     Optional enrollment in pre/post neuroimaging will also allow us to look at changes in the     brain.   "
158629|NCT01207349|"     Three hundred and ninety height diabetic patients were educated during a week of     hospitalisation (nutritional and physical-activity advices). After that, they were randomized     in two groups : frequent follow-up (each three month) by educational nurses and dieteticians,     versus no follow-up (control group). All patients were evaluated one year after their     inclusion,by HbA1c (primary outcome), anthropometry, other cardiovascular risk factors,     nutritionnal and physical-activity behaviours.   "
158630|NCT01207336|"     Recent work showed that application of peripheral nerve and cortical stimulation     independently can induce 10-15 % improvement in motor performance in patients with chronic     stroke.      The purpose of this study was to compare in post-stroke hemiplegic patients the effect on     motor recovery of one session of anodal transcranial direct current stimulation to the     ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical     stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the     same peripheral nerve stimulation combined with sham tDCS.      Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for     the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary     outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability     of Ipsilesional M1(TMS) Follow-up: 30 days   "
158651|NCT01207063|"     The investigators group uses an individualised radiation dose approach in which the dose is     escalated up to pre-defined tissue constraints (see below). The target dose to the tumor is     69Gy. However, this dose cannot be reached in approximately 30% of the patients, even with an     IMRT (Intensity Modulated Radiotherapy) technique, because the MLD (Mean Lung Dose)     constraint of 20Gy is reached at a TTD (Total Treatment Dose) below 69Gy. In this study, the     investigators will adapt the treatment by performing a new (PET)-CT at day 12 during     radiotherapy and in case of a decreased Planning Target Volume (PTV), the dose mey be     increased.   "
158631|NCT01207323|"     This is a Phase I, multicenter, open-label study of MEHD7945A in participants with incurable,     locally advanced, or metastatic epithelial malignancies that have progressed despite standard     therapy or for which no standard therapy exists. The study will be conducted in two stages: a     dose escalation stage and an expansion stage. The dose-escalation stage is designed to     evaluate the safety, tolerability, and PK of MEHD7945A administered (at five dose levels from     1 to 30 milligrams per kilogram [mg/kg]) every 2 week (Q2W). An expansion stage will be     initiated after establishment of maximum tolerated dose (MTD) in dose escalation stage.     Participants with refractory or recurrent metastatic colorectal cancer (CRC), non-small cell     lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and pancreatic cancer     will be enrolled in an expansion stage to better characterize the safety, tolerability, PK     and preliminary assessment of the anti-tumor activity of MEHD7945A.   "
158632|NCT01207310|"     The proposed study tests the efficacy of using pager-assisted messages combined with nicotine     patches in facilitating smoking cessation and relapse prevention in a 2-arm randomized     clinical trial. The hypothesis is that the proportion of biochemically-verified quitters at 3     and 12 months in the study arm randomized to receive therapeutic messages on alphanumeric     pagers for 3 months along with individual smoking cessation counseling and nicotine patches     will be greater that the proportion of biochemically-verified quitters who receive only     individual smoking cessation counseling and nicotine patches.   "
158633|NCT01207297|"     In this comparative open-label cohort study, the investigators compared the efficacy and     safety of tacrolimus (TAC)and cyclophosphamide (CYC) in the treatment of diffuse     proliferative and membranous lupus nephritis with severe renal disease. Treatment of lupus     nephritis (LN) with cyclophosphamide is effective, but retain a certain proportion of renal     function exacerbations. Tacrolimus may be a suitable substitute treatment for CYC.      Methods: Forty patients with diffuse proliferative or membranous were recruited for this     trial, 45% of them had lower Ccr (<60mL/min/1.73m2), 10% had increased serum creatinine     (>180µmol/L) and 67.5% had nephritic proteinuria (>3.5g/day). The investigators compared the     efficacy and adverse effects of TAC (0.04-0.08 mg/kg/d) and prednisone for 12 months (TAC     group) with pulse cyclophosphamide (750mg/m2 per month for six months) and prednisone     followed by azathioprine (50mg/day）for 6 months (CYC group).   "
158634|NCT01207284|"     The hypothesis is that a physical therapy intervention for foot and ankle of diabetic     neuropathic individuals would affect positively the way they walk, lowering the harmful     forces that these segments receive, that are associated mainly with lower range of movement,     muscle weakness and loss of sensation. The participants will be randomly assigned into     control group (regular treatment prescribed by their medical group) or into treatment group,     that will receive 12 weeks of physical therapy intervention, twice a week, for 45 minutes     each session. This will aim for increasing foot and ankle range of movement, muscle strength     and improving sensory inputs.   "
158635|NCT01207271|"     The goal of this study is to compare supportive-expressive therapy, a type of psychodynamic     psychotherapy, with cognitive therapy for the treatment of depression in community mental     health consumers.      Hypothesized mediators of treatment will also be examined.   "
158636|NCT01207258|"     This study is a randomized controlled trial of a brief intervention for women Emergency     Department patients with involvement in both Intimate Partner Violence (IPV) and problem     drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The     study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief     motivational intervention, delivered by social workers in the Emergency Department setting,     in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with     resources. Social work graduate students and/or staff will be trained to provide brief     motivational enhancement therapy (MET) intervention for decreasing heavy drinking and     IPV-related injury in women Emergency Department patients.   "
158648|NCT01207102|"     Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane®     (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and     tolerability. When combined with a taxane, platinum agents improve response in metastatic     breast cancer, with carboplatin conferring less toxicity than cisplatin. The investigators     hypothesize that the combination of weekly Abraxane® and carboplatin will lengthen time to     progression without producing intolerable toxicity.   "
158649|NCT01207089|"     The purpose of the study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of AZD8329 following multiple ascending dose administrations in in     overweight to obese but otherwise healthy male subjects.   "
158650|NCT01207076|"     This study is a single institution phase I study for the treatment of patients with relapsed     or refractory leukemia aged 12 years and older using 90Y-AHN-12.   "
158734|NCT01206205|"     The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with     bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This     study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone will     increase the Complete Response (CR)/ very good partial response (VGPR) rate before and after     High Dose Therapy (HDT) with ASCT.   "
158652|NCT01207050|"     This pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among     individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both     objective and subjective measures. It will also show that improvement in sleep/wake patterns     resulting from Rozerem will impact daytime functioning using objective and subjective     measures.   "
158653|NCT01207037|"     Acute splenic sequestration is a frequent and life threatening complication occurring in     approximately 10 % of homozygous children. Maximal incidence is between 6 and 18 months.      The investigators formulate the hypothesis that there are clinical, biological and genetic     markers predictive of severe complications notably acute splenic sequestration in SCD     children. The present research project thus aims at analyzing in a forward-looking way the     profile of severity by analysing clinical, biological and genetic characteristics in a     multicentric cohort of 60 SCD children   "
158654|NCT01207024|"     Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal     of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious     sub-chondral bone) before and one year after bariatric surgery.      Knee MRI is not currently part of the investigations preceding bariatric surgery.   "
158637|NCT01207245|"     Cystic fibrosis is the most common inherited life limiting condition which affects children.     Patients with it develop lung infections which become difficult to clear, and damage the     lungs. These are treated with antibiotics (such as tobramycin) into the vein (termed     intravenous antibiotics). This has without doubt improved survival. However, all treatments     have side effects. Tobramycin can cause kidney damage. The investigators have preliminary     data that suggests that administering tobramycin in the morning may be safer for the kidneys     than administering it in the evening.      The investigators plan to approach children and adults with cystic fibrosis whose doctors     have decided to administer a course of intravenous tobramycin. The investigators will     randomly allocate them to receive it at either 0800h or 2200h. The investigators will measure     the rate at which the body eliminates tobramycin from the bloodstream, by measuring the     amount of tobramycin in the blood stream after administering the antibiotic. For each patient     the study will last for the duration of the course of antibiotics. This is decided by the     doctor looking after the patient (rather than the researcher), and would typically be 14     days. The investigators will also measure substances in the blood and urine (biomarkers)     which are sensitive indicators of low levels of kidney injury. The investigators will monitor     lung function and lung bacteria in both the groups to ensure that the patients in both groups     improve by the same amount.      If the preliminary data are proved correct, this research will allow investigators to improve     the safety profile of tobramycin, one of the most widely prescribed drugs in cystic fibrosis.   "
158638|NCT01207232|"     The investigators conducted a 3-arm randomized controlled trial to test whether a low-cost     planning intervention could increase influence vaccination rates.   "
158639|NCT01207219|"     The current study aims to evaluate the impacts of yoga and aerobic exercise on     neuro-cognitive function, symptoms and brain changes in early psychosis. A total of 120     female subjects who aging from 18-55 years old, and diagnosed with psychotic disorders within     the past 5 years, will be randomized into 3 groups: 1) yoga therapy, 2) aerobic exercise, and     3) waitlist group as the control. All groups will try to be kept consistent with their     medication with no more than 25% change in their entry level dosage for at least six weeks.     The primary outcomes of the present study will be neuro-cognitive changes; the secondary     outcomes will be changes of brain structure and function.   "
158640|NCT01207206|"     In the current research the investigators would like to examine the effect of a well     acquainted drug, Ketamine, which is used by anesthesiologists to induce sleep in operations.     Usually the ketamine is given into the vein and not orally. The investigators want to give it     orally to cancer patients that sufffer from severe pain to find out whether it can prove     their quality of life, lower their pain and reduce the amount of opioids they receive.   "
158641|NCT01207193|"     There are two types of bone cysts, unicameral and aneurismal. These cysts happen to anyone,     but they are most commonly seen in children and young adults while their bones are still     growing. Living with a bone cyst and determining treatment options depend on the type of     cyst.      Non-surgical treatments for unicameral bone cysts involves repeated X-rays in individuals who     do not experience any symptoms.      Surgical removal of a unicameral bone cyst is needed if it becomes especially painful, or the     area of the bone starts to thin out. The investigators aim to assess the clinical efficacy     and side effects of mesenchymal stem cells seeded on bone matrix in repairing bone cyst.   "
158642|NCT01207180|"     The investigators hypothesize that the acquisition and correct utilization of medications as     well as arranging and attending follow-up appointments will improve as a result of a phone     call intervention 1-3 days after elderly patients are discharged from the emergency     department (ED).   "
158643|NCT01207167|"     South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high     rates of cardiovascular disease that is not explained by traditional cardiovascular risk     factors. Though South Asians represent over one-quarter of the world's population, there are     no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a     longitudinal study of South Asians at two United States centers to identify risk factors     linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of     this study is to understand the causes of heart disease and stroke in South Asians and     compare these causes to those in other United States ethnic groups.   "
158644|NCT01207154|"     The purpose of this study is to determine whether or not a device which measures depth of     anaesthesia and sedation can be used to assist in the sedation of patients who must have     breathing tubes positioned in their airways before general anaesthesia   "
158645|NCT01207141|"     This open-label clinical trial will evaluate the pharmacodynamics, pharmacogenomics and early     efficacy and safety of steroid-free Tacrolimus (TAC) monotherapy and its minimization after     induction with rabbit, anti-human thymocyte globulin (rATG, Genzyme, Cambridge, MA) in     children and adults with pediatric liver transplantation. Eighty subjects (0-21 years)     receiving liver transplantation will be enrolled. Incidence and severity of biopsy-proven     acute cellular rejection (ACR) is a primary endpoint as well as time to Tacrolimus whole     blood concentrations <8 ng/ml The expected incidence of ACR is 50% and is derived from a     non-consecutive subject population (n=40) who received an identical regimen in IND 64555.     This incidence is acceptable because the long term sequel of rejection reported with other     allografts have not been observed in liver grafts during IND 64555. These risks are further     negated by the unique regenerative capacity of the liver allograft. An OBSERVATIONAL arm is     being included in this trial. Because the numbers of pediatric liver transplants (LTx) are     small in any single center setting, no information is known about relative outcomes on a     conventional protocol, in children receiving conventional protocol of steroids+Tacrolimus.     The PURPOSE of this additional recruitment is OBSERVATIONAL, only. Therefore, these subjects     will NOT be randomized. Rather, by studying all types of patients, the investigators hope to     utilize maximally, all available subjects, to understand the relative place of     monotherapeutic induction. In turn, this will be the basis for a follow-up comparative,     randomized trial.   "
158646|NCT01207128|"     The purpose of this study is to evaluate the therapeutic effectiveness of combination     antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo     equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological     cancer.   "
158647|NCT01207115|"     To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to     placebo in subjects with osteoarthritis (OA) of the knee.   "
158656|NCT01206998|"     The purpose of this study is to compare how well vaginal progesterone works delaying the time     to delivery in women with preterm labor compared to placebo. The study will also compare the     effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery,     cervical length and biomarkers of preterm delivery in women diagnosed with and treated with     medication to stop preterm labor.   "
158657|NCT01206985|"     Paracetamol is the analgesic most used, indicated in the symptomatic treatment of fever and     pain of mild to moderate. It comes in different dosage forms intended for oral, intravenous     and rectal.      The per-oral mucosal route is not used for the administration of paracetamol. It is a very     interesting way for the rapid absorption of drugs such as nitrates used in angina pectoris,     as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows     very rapid action. In addition, the oral administration-oral mucosa, less restrictive than IV     administration and faster than oral administration, seek a single medical procedure     unattended after dosing, will entail no pain or risk for infections the patient (in contrast     to the IV). The investigators tested a new oral dosage form permucosal (at 250mg/ml) of     paracetamol and compared at pharmacological (pharmacokinetic and pharmacodynamic) with the     only dosage form of reference used by the IV route in the protocol Pilot study Pharmacology     paracetamol administered oral permucosal PMB. It seems interesting now to reduce the dose by     half permucosal to assess how changing the pharmacodynamics of the form permucosal to     125mg/ml. This form will be administered in oral permucosal buccal as well as sublingual     (under the pillar of the language) and compared with paracetamol in IV.   "
158658|NCT01206972|"     The objective of this dose-confirmatory bridging study is to investigate the safety and     efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous     thromboembolism (VTE) in Japanese patients undergoing elective total knee replacement (TKR)     and to confirm the extrapolability of global data to Japanese patients by comparing with data     from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.   "
158659|NCT01205945|"     Abdominal aortic aneurysm(AAA) occurs when the infrarenal aorta expands to a maximal diameter     of 3.0cm or greater. Although AAA may asymptomatic for many years, almost one third     eventually rupture if left untreated.      Several randomized trials showed that ultrasonographic screening for AAA could reduce the     frequency of acute operations and AAA-related mortality.      However, all of randomized trials were performed in Western countries. There was no     randomized trials for AAA screening in Asian countries.      This randomized, controlled trial is to analyze the benefits of screening old population for     AAA in Korea.   "
158660|NCT01205932|"     The objective of this dose-confirmatory bridging study is to investigate the safety and     efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous     thromboembolism (VTE) in Japanese patients undergoing elective total hip replacement (THR)     and to confirm the extrapolability of global data to Japanese patients by comparing with data     from overseas phase II study (ODIXa-OD.HIP - Study 11527).   "
158661|NCT01205919|"     The purpose of this study is to determine the efficacy of a cognitive behavioral guided     self-help training provided via the internet on tinnitus distress in a German sample.   "
158662|NCT01205906|"     The aim of this study is to compare the efficacy of an internet-based guided self-help     training for chronic tinnitus with a well-established outpatient group therapy and a     discussion forum group.   "
158663|NCT01205893|"     The purpose of this study is to determine if the Reducer is safe and effective in treating     the symptoms of refractory angina in patients that suffer from refractory angina who     demonstrate reversible ischemia.   "
158664|NCT01205880|"     This investigator-blinded study is designed to assess whether the order of application     affects the efficacy of the combination treatment Clobex® Spray (clobetasol propionate) and     Vecitcal® (calcitriol) Ointment in plaque psoriasis.   "
158665|NCT01205867|"     The purpose of this study is to investigate the safety and tolerability of AZD8848 in     Butyrylcholinesterase deficient subjects in comparison with sex and age matched control     subjects.   "
158680|NCT01206907|"     The purpose of this study is to evaluate the effectiveness, tolerability, and safety of     oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having     severe to moderate chronic pain.   "
158735|NCT01206192|"     The purpose of this study is to extend the extant work on the typology of intimate partner     violence (IPV) by employing mixed methods to collect quantitative and qualitative data.   "
158666|NCT01205854|"     The ultimate goal of treatment in early rheumatoid arthritis (RA) is remission, i.e. an     absence of signs and symptoms of the disease. However, the optimal way of reaching this goal     is not known.      Ultrasonography (US) is an imaging modality which application is rapidly growing. It has a     number of advantages over other advanced imaging techniques such as magnetic resonance     imaging (MRI), including low cost, good accessibility, and ability to scan many joints in a     short period of time. However, the additional benefit of using this modality in terms of     patient outcomes has not been demonstrated. Thus, clarification is needed if the use of US     leads to better care for RA patients.      This study will assess if the use of a treatment strategy incorporating information from     ultrasonography assessment will allow for better outcomes of patients with RA, than a     strategy based on clinical and laboratory assessments alone.   "
158667|NCT01205841|"     Comparison of the reliability of different examination techniques to detect fractures in     patients with ankle trauma.   "
158668|NCT01205828|"     This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in     abbreviation).      The purpose of this study is to test the efficacy (effectiveness) of a new combination of     drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging     deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888     inhibits an enzyme called PARP which helps to fix damaged DNA. By inhibiting this enzyme,     ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will     hopefully increase the killing of cancer cells, and decrease the tumors in the body.      ABT-888 is an investigational or experimental anti-cancer agent that has not yet been     approved by the Food and Drug Administration (FDA) for use in liver cancer.      This study will help find out what effects (good and bad) the combination of drugs,     temozolomide and ABT-888, has on liver cancer.      This research is being done because it is not known if ABT-888 will increase the     effectiveness of temozolomide in liver cancer.   "
158670|NCT01205802|"     Middle hepatic vein (MHV) reconstruction with an interposition vessel graft has been settled     as a standard procedure for living donor liver transplantation (LDLT) using a right lobe     graft. Increasing demand of vessel graft in the situation of limited resources of allograft     led the investigators to search for new vessel substitutes. Since the use of thin-walled     expanded polytetrafluoroethylene (PTFE) graft showed poor long-term patency, a prospective     study is going to be performed to enhance the clinical usability of expanded PTFE graft. A     clinical study intends to know how to maintain its luminal flow effectively by using ringed     PTFE graft. During 12 months of study period, ringed PTFE graft will be used for     reconstruction of MHV reconstruction. The investigators expect that ringed PTFE graft seems     to be a more useful alternative than usual PTFE graft when adequate autologous or allogenic     vessel graft is not available.   "
158671|NCT01205789|"     The purpose of the Universal Registry is to assess the proportion and reasons for which     subjects with angiographically significant ULMCA disease requiring revascularization during     the time course of this study are not randomized; to compare the baseline characteristics of     subjects; and to assess the variability in randomization eligibility and treatment patterns.   "
158673|NCT01205763|"     In this study, the investigators intend to demonstrate that the hook plate may have adverse     effects on subacromial structures even with a short period of hardware retention. The     investigators also sought to determine if musculoskeletal sonography could be used as a tool     to demonstrate shoulder pathology such as subacromial impingement or rotator cuff tear in     patients receiving hook plate fixation. The clinical results of patients receiving hook plate     fixation, specifically bony union, pain relief, shoulder function and range of motion (ROM),     were also evaluated.   "
158674|NCT01205750|"     Obesity is associated with dyslipidemia, which is a major risk factor for coronary heart     disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins,     and the metabolism of these lipids in plasma is closely interrelated. Evidence suggests that     increased concentration of very low-density lipoprotein triglyceride (VLDL-TG) is a central     pathophysiological feature of the lipid and lipoprotein abnormalities in dyslipidemia.      The primary objective of this study is to investigate VLDL-TG kinetics and hepatic insulin     sensitivity in age-matched obese and lean, healthy men in the postabsorptive state and during     acute hyperinsulinemia using VLDL-TG and glucose tracers.   "
158675|NCT01205737|"     This is a prospective international, multi-center, randomized, double-blind controlled study     designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of     MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse     large B cell lymphoma.   "
158676|NCT01206959|"     The purpose of this study is to monitor the blood pressure level of the patient using a blood     pressure monitor which test the blood pressure level in inflating state . The cuff range in     the study is 22cm-48cm   "
158677|NCT01206946|"     The hypothesis of the study is that administration of antenatal steroid to women at high risk     of preterm birth after 34 weeks of gestation would reduce the risk of respiratory     complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the     Newborn (TTN) in late preterm babies.   "
158678|NCT01206933|"     Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and     Molecular Biology of The George Washington University Medical Center are carrying out a     research study to determine why patients with Human Immunodeficiency Virus (HIV) and     Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of     HCV infection, leading to fatty infiltration of the liver and cirrhosis.   "
158679|NCT01206920|"     The goal of the DC Cohort is to establish a clinic-based city-wide longitudinal cohort that     will describe clinical outcomes, and improve the quality of care for outpatients with Human     Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) in Washington, DC.   "
158681|NCT01206894|"     Non-Small Cell Lung Cancer (75% of lung cancer) is associated with involvement of the     parietal pleura and or chest wall (soft tissue and/or bone) in 5-8% of patients. Invasion of     the chest wall increases the T staging in the Tumor, Node, Mestasis (TNM) classification     system of lung cancer to a T3 and is associated with decreased survival and more extensive     operative procedures. The reported 5-year survival for patients with T2 tumors is 58%     compared to 38% in patients with T3 lesions. The American college of Chest Physician has     still not identified the best tool to assess chest wall invasion by lung cancer, CT-Scan     being used by physicians for this assessment. In some studies, CT scan has been shown to have     a sensitivity ranging from 42 % to 68 % in assessing chest wall invasion, and a specificity     ranging from 66 % to 100 %.      Trans-thoracic Ultrasound (US) has the capacity of allowing for dynamic real-time imaging of     the pulmonary lesion and the chest wall. Therefore, US has the potential to allow for the     appreciation of subtle findings related to the movement of the lesion and lung over the chest     wall. Hence, US might be an accurate tool to assess chest wall invasion by lung cancer; thus     improving pre-operative diagnosis, staging and operative planning of patient with chest wall     invasion.      However US is not currently utilized in the pre-operative assessment of patients with lung     cancer invading the pleura and chest wall, and has not been extensively studied.      In some rare studies evaluating the accuracy of US, results have shown a sensitivity ranging     from 89% to 100% and a specificity ranging from 95% to 98% for US detecting chest wall     invasion by lung cancer. However those studies got criticized. Bandi et al study, got     criticized by the fact that the operators in the study were experienced interventional     pulmonologists who perform hundreds of thoracic and endoscopic ultrasound per year. Nobuo et     al study took place in 1993, since when the device of US has evolved, the investigators can     not apply with certainty the findings of this study.      Consequently, there is a need to conduct a study to evaluate the accuracy of US to assess     chest wall invasion by lung cancer.      In this prospective study the investigators will assess the accuracy of US, and then compare     it to the accuracy of the CT-Scan   "
158682|NCT01206881|"     The purpose of this study is to determine the efficacy of neoadjuvant treatment with     pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by     docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary     tumor > 5 cm.   "
158683|NCT01206868|"     A single centre open randomised parallel-group study to evaluate whether prophylactic     fenestration of the peritoneum at the time of renal transplantation prevents lymphocele     formation.      Adult (>18 years old) recipients of renal transplants from deceased donors were eligible for     inclusion. From March 2007 to May 2009 130 patients were included. The patients were     randomized either to peroperative peritoneal fenestration, or to serve as controls.     Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes     from each group. Patients who previously had undergone extensive abdominal surgery, or were     included in other studies were excluded.   "
158684|NCT01206855|"     A clinical trial to evaluate the effect of MIST Therapy on outcomes after cosmetic     procedures(including facelifts, blepharoplasties, breast augmentations and reductions,     mastopexies, and abdominoplasties) traditionally associated with pain, swelling, bruising,     and scarring. The study will test the hypothesis that MIST Therapy can decrease the incidence     and severity of these surgical sequelae throughout the acute and sub-acute phases of healing.   "
158685|NCT01206842|"     People with schizophrenia show deficits in social cognition, the ability to process     information about other people such as identifying their emotional expressions. Social     cognition is associated with everyday life functioning and could therefore be an important     treatment target. Several social cognitive training programs have been developed during the     last years. Results indicate that social cognitive performance can be ameliorated through     commonly used intervention techniques. However, it is less clear whether this improvement     generalizes to everyday life. The purpose of this study is to investigate if a social     cognitive training program (Training in Affect Recognition) improves performance on social     cognitive and neuropsychological tests and leads to improved everyday life functioning in     persons with schizophrenia. The study also aims at examining if an improvement is present     three months after completion of the training intervention.   "
158686|NCT01206829|"     A randomized controlled study with hearing impaired workers, who have voluntarily signed up     for an 8 session cognitive therapy (CBT) course The CBT intervention will be compared to a     waiting list control group. Participants who are allocated to the intervention group will be     offered to start on the CBT-course immediately, while the control group that will be offered     the same course 12 months later. Main outcome measures are assessments of mental distress and     vocational coping. We will also assess the distress associated with tinnitus, which is a     potential moderator variable.   "
158687|NCT01206816|"     The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD)     in terms of safety and tolerability of the combination of BI 6727 with BIBW 2992, in patients     with advanced or metastatic solid tumours. Dosages of both BI 6727 and BIBW 2992 will be     varied to establish the MTD of the combination. Two combination treatment schedules will be     tested, the MTD of each combination will be determined.      Secondary objectives are the exploration of pharmacokinetics, overall safety and preliminary     efficacy.   "
158688|NCT01206803|"     The aim of the study is to explore ovarian response in terms of oocyte numbers after ovarian     stimulation in a fixed gonadotropin dose GnRH-antagonist protocol by endocrine (AMH, FSH),     demographic (age), sonographic (antral follicle count) and genetic factors (polymorphisms of     gonadotropin receptors and secreted gonadotropins).   "
158689|NCT01206790|"     Posttraumatic stress disorder (PTSD) is associated with poor health, high health care     utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune     diseases. Research, including our own findings, indicates immunological alterations in PTSD     patients. The aim of this study is to investigate whether alterations in the immune system of     PTSD patients are reversible through a trauma-specific short-term therapy (Narrative Exposure     Therapy).   "
158690|NCT01206777|"     The purpose of this study is to assess the feasibility of a 60 minute rapid infusion     rituximab protocol in the institution's outpatient infusion center.   "
158706|NCT01206569|"     Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus     (SLE). Around one-third of the patients, however, do not respond to conventional     immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent     renal failure. Recent studies suggest that immunosuppressive therapy targeted against the     calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the     treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm     study the efficacy and safety of long-acting tacrolimus in the treatment of     treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis     will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for     6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal     function, clinical and serologic lupus activity will be monitored. This study will explore     the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor     prognosis and no effective treatment at the moment.   "
158691|NCT01206764|"     Renal cell carcinoma (RCC) accounts for more than 200,000 new cases of cancer and over     100,000 cancer deaths annually in the World (Ferlay, et al., 2004). It is estimated that     there were about 15,000 new cases of RCC in the region that excludes the Americas, European     Union and Japan. Renal cell carcinomas arise from the proximal tubal epithelium are more     common in males than in females with an overall lifetime risk of 1 in 75 and a median age of     diagnosis of 65 years.      Everolimus (Certican®) has been approved since 2003 in more than 60 countries for the     prevention of organ rejection in patients with renal and cardiac transplantation. Everolimus     (RAD001) is a derivative of rapamycin, which acts as a signal transduction inhibitor. It     targets mTOR, a key protein kinase regulating cell growth, proliferation, and survival. The     mTOR pathway activity is modulated by the phosphatidylinositol-3-kinase (PI3K)/protein kinase     B AKT (AKT) pathway, a pathway known to be deregulated in numerous human cancers. RAD001     (Afinitor®) has been investigated as an anticancer agent based on its potential to act:        -  directly on the tumor cells by inhibiting tumor cell growth and proliferation;        -  indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent          inhibition of tumor cell hypoxia-inducible factor 1 (HIF-1) activity, VEGF production,          and VEGF-induced proliferation of endothelial cells).      Primary: To evaluate the PFS rate over time.      Secondary:        -  To evaluate the disease control rate (stable disease [SD] + partial response [PR] +          complete response [CR]);        -  To evaluate the objective response rate (ORR; where ORR = CR + PR) and duration;        -  To describe the safety profile of RAD001.   "
158692|NCT01206751|"     Multi-detector computer tomography protocol project: Chest imaging technique and case     presentation.   "
158693|NCT01206738|"     1. Do paper-based and web-based intervention modelling experiments (the methodology we are          developing) identify the same predictors of GP behaviour regarding prescribing of          antibiotics for upper respiratory tract infections?        2. Can a web-based IME system provide trialists with richer and more predictive information          upon which to base the development of behavioural change interventions than paper-based          IME systems?   "
158724|NCT01206335|"     The purpose of this study is to determine whether patients with advanced cancers who receive     OHR/AVR118 solution for injection into the skin can achieve improvement in quality of life.     Based on a previous study in patients with AIDS, possible benefits may include improved     appetite and strength; weight gain, improved mood; and decreased fatigue.   "
171269|NCT00079664|"     The purpose of this study is to examine the effects of Tai Chi, in comparison to conventional     exercise, on the quality of sleep among sedentary older adults.   "
158694|NCT01206725|"     The aim of the study is to compare the effects of aerobic interval training and the IDF     recommendations on physical activity on cardiac function and CV risk factors in patients with     diabetes. The hypothesis is that AIT more than MCT, will improve myocardial dysfunction in     patients with subclinical LV disease, improve both endothelial function and VO2max and thus     reducing CV risk factors and CV disease. HbA1c will be more stable.      The aims of this study are to address the exercise prescription recommendations for patients     with (T2DM) who have subclinical heart disease. The prescription recommendations will be     assessed by randomising T2DM patients with subclinical heart disease to one of the following     2 groups for 3 months followed by a 9 month home-based program:      Moderate Intensity Exercise Group (ME). Home exercise equivalent to the present exercise     recommendations of the International Diabetes Federation.      Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved     through high-intensity interval training.   "
158695|NCT01206712|"     The purpose of this phase IV clinical trial is to investigate the effect of Insulin glargine     + metformin treatment vs. sulfonylurea + metformin treatment vs. DPP-4 + metformin treatment     vs. healthy volunteers on ß-cell function after the uptake of a standardized meal.   "
158696|NCT01206699|"     The specific aim of this study is to determine whether, when treated with corticoid     infiltration, certain chronic lumbagos could be explained by the presence of a     neo-articulation.The primary criteria is to determine the difference between the mean pain     during the latest 24 hours preceding the infiltration and the mean pain preceding the visit     S4 (visit 4 weeks after the infiltration)   "
158697|NCT01206686|"     The goal of this project is to see if encouraging an individual to privately choose in     advance a narrow time window in which to obtain a flu vaccination shot affects the likelihood     that he or she will become vaccinated.   "
158698|NCT01206673|"     The aim of this study is to evaluate macrophaging activity and immunologic profile of     patients with Gaucher 's disease. For this, one blood sampling will be performed.   "
158699|NCT01206660|"     The objective of this study is to demonstrate that desoximetasone 0.25% topical spray is     effective for the treatment of patients with moderate to severe plaque psoriasis.   "
158700|NCT01206647|"     The purpose of this study is to investigate the success rate of a switch from insulin therapy     to a metformin & saxagliptin combination in patients with type 2 diabetes mellitus.   "
158701|NCT01206634|"     The objective is to assess the effectiveness of regenerative injection therapy (RIT) to     relieve pain and restore function in patients with knee osteoarthritis.      The study design is a randomized controlled trial with cross-over. 40 patients with chronic     knee osteoarthritis will be randomly assigned to receive exercise therapy for 32 weeks in     combination with RIT on weeks 0, 4, 8, and 12 or exercise therapy for 32 weeks combined to     RIT on weeks 20, 24, 28 and 32. The primary outcome is the WOMAC score.   "
158702|NCT01206621|"     For the patient with acute dyspnea in the ED, early differentiation between CHF and non-CHF     causes is essential for proper management. The capacity to triage patients quickly and     accurately has a beneficial impact upon outcome, disposition, stratification and length of     stay in the ED and required length of hospital admission.      The ability to assess pulmonary status rapidly by quantitative regional vibration technology     offers significant potential advantage for earlier diagnosis. The VRI technique may provide a     quick and accurate method of differentiating between dyspnea due to HF and dyspnea due to     pulmonary causes; thereby improving management and outcomes.   "
158703|NCT01206608|"     The primary objective of this study was to demonstrate the superiority of SKY0402 over     conventional, commercially-available bupivacaine HCl with respect to the duration of the     analgesic effect achieved by a single local administration of the study drug.   "
158704|NCT01206595|"     The primary objective of this study was to determine the appropriate dose of SKY0402     administered as a nerve block for the management of postoperative pain following     bunionectomy.   "
158705|NCT01206582|"     This study is designed to learn if hemin can increase the production of heme oxygenase 1 and     improve gastric (stomach) emptying and symptoms in diabetic patients with slow gastric     emptying (gastroparesis).   "
158731|NCT01206244|"     This study is to determine the diurnal variation of tear meniscus and tear osmolarity in     normal subjects and dry eye patients.   "
158707|NCT01206556|"     This study is being done to evaluate how long the immune response from the Human Papilloma     Virus (HPV) vaccine you / your child received persists. The immune response occurred after     immunization and is what protects you/your child from HPV disease. You / your child received     this vaccine as part of an earlier study (P1047). The vaccine is called Human Papillomavirus     Vaccine (QHPV Vaccine, also known as GARDASIL®). The study will check to see if the     protective effects (called antibodies) produced by the vaccine have lasted, and for how     long these effects will continue to last. You will not be given any medications or vaccines     as part of this follow-up study.   "
158708|NCT01206543|"     Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in     craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal.   "
158709|NCT01206530|"     In this Phase I/II clinical trial, the investigators seek to pilot the addition of     hydroxychloroquine (HCQ) to the standard front-line therapy of colorectal cancer,     FOLFOX/bevacizumab. In toxicity terms, the investigators previous studies lead them to     believe that a full dose (800mg) of HCQ will be well-tolerated in this setting. By starting     at 600 mg, the investigators will ensure that the full dose is approached with an eye to     safety, and if needed, the investigators will use the lower dose. Both doses achieve     autophagy inhibition in our current studies.   "
158710|NCT01206517|"     This study is an open label, sequential-group, two site, multiple dose escalating study of     sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I     disorder; in one study cohort (3a) participants with other conditions treatable with chronic     antipsychotic medication can also be enrolled. Participants will receive a single sublingual     placebo dose on Day -1, followed by multiple sublingual doses of asenapine twice daily     (b.i.d.) for 6 days (Cohorts 1 and 2), 7 days (Cohort 3b-d), or 11 days (Cohort 3a), and a     final once daily administration on Day 7 (Cohorts 1 and 2), Day 8 (Cohort 3b-d) or Day 12     (Cohort 3a).   "
158711|NCT01206504|"     This study will test an experimental drug called MGAWN1 for the treatment of West Nile     infections.   "
158712|NCT01206491|"     Department of Chronic Disease and Health Promotion of World Health Organization listed eight     classes of chronic disease which will be important globally in the future. And the sixth     class is Chronic Rheumatic Condition, which includes rheumatic arthritis, osteoarthritis,     osteoporosis, spinal disorders and severe limb trauma. Obviously the osteoporosis is a     globally important health topic.      Osteoporosis draws more and more attention, because osteoporosis has various influences, for     example, (1) psychologically impact which occurs frequently in many chronic diseases, such as     depression will appear evidently in patients with osteoporosis (2) patients with osteoporosis     often lose their social role (3) osteoporosis might induce pain and limitation of body     function (4) osteoporosis increases greatly the possibility of fracture. Osteoporosis will     induce adverse outcomes, such as the fall of life quality, the increase of morbidity and     mortality, as well as the increased abuse of medical service. In this project, the     investigators will set up the intervention model for prevention of osteoporosis as well as     falls.      In this project, the investigators will recruit patients form outpatient services at WanFang     Hospital. Through the collection of baseline data from questionnaire and bone density     measurement, the investigators can clarify the risk of osteoporosis and falls in studied     patients. By using double-blind randomized design, the patients will be collected to either     one of intervention and control group. After eight weeks of intervention programs, the     investigators will follow on both groups to understand the effect of this program and to     increase the bone density of intervention group. The hospital or the Health center might take     the outcome to be the reference of taking care the Osteoporosis.   "
158713|NCT01206478|"     Gastrojejunal (G-J) feeding tubes are placed in infants and children who refuse to eat or are     unable to eat enough to have normal growth. Although often intended as temporary short-term     solutions to medical complications, feeding tubes can become a permanent method for eating.      While tube feeding routinely saves the lives of children who have long term food refusal,     continuation of tube feeding can be hard for patients, caregivers, and families. At the     current time there are few treatments for helping children move from tube to oral feeding.     Some patients may be treated with the help of inpatient programs such as a combination of     medical and behavioral techniques to train children to eat orally. These programs typically     require hospital stays of 2-4 months.      By doing the current study the investigators hope to learn if the investigational drug     amitriptyline is helpful in moving children from tube to oral feeding, and to look at whether     or not the treatment of pain helps with this transition.   "
158714|NCT01206465|"     RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving pralatrexate together with fluorouracil may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of pralatrexate when     given together with fluorouracil in treating patients with recurrent solid tumors   "
158715|NCT01206452|"     The primary purpose of this study is to assess the efficacy of oral prednisone in improving     the outcomes of pulmonary vein isolation with radiofrequency ablation.   "
158716|NCT01206439|"     The purpose of this study is to determine if Nebivolol has any effect on heart function     determined by changes in echocardiographic data or exercise tolerance.   "
158717|NCT01206426|"     This is observational clinical trial to study adult urothelial cancer patients treated with     cisplatin‐based neoadjuvant chemotherapy.      Hypothesis: Identification of genetic and molecular cisplatin susceptibility biomarkers     will allow identification of urothelial cancer patients most likely to benefit from     cisplatin‐based neoadjuvant chemotherapy.   "
158732|NCT01206231|"     This study is aimed to collect the following Serbia-specific epidemiology data on     hypercholesterolemia: patents characteristics, patients' management/treatment and physicians'     standard practice. In addition, the aim is to determine the proportion of patients on     lipid-lowering pharmacological treatment who have reached the LDL-C and HDL-C treatment     goals.   "
158733|NCT01206218|"     Evaluation of customized treatment according to BRCA1 assessment in patients with advanced     gastric cancer   "
175021|NCT00132665|"     The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in     longer survival than radiotherapy alone in elderly patients with unresectable stage III     NSCLC.   "
158718|NCT01206413|"     The study investigated the effectiveness of home-based exercise combined with a slight     caloric restriction on weight change during 12 months in non-obese women. In addition the     investigators evaluate the effects of baseline insulin resistance on modulation of weight     change.      A randomized clinical trial with a factorial design was conducted from 2003 to 2005. Two     hundred three middle-aged women (Rio de Janeiro/Brazil), 25-45 years, were randomly assigned     to one of two groups: control (CG) and home-based exercise (HB). The HB group received a     booklet on aerobic exercise that could be practiced at home (3 times/week - 40 min/session),     in low-moderate intensity, during 12 months. Both groups received dietary counseling aimed at     a slight energy restriction of 100-300 calories per day.      The HB experienced a greater weight loss in the first 6 months (-1.4 vs. -0.8 kg; p=0.04),     but after 12 months there was no differences between groups (-1.1 vs. -1.0; p=0.20). Of the     serum biochemical markers, HDL-cholesterol showed major change, with an increase at month 12     of 18.3 mg/dl in the HB compared to 9.5 in the CG (p<0.01). At baseline the non-IR group     (n=121) compared to IR (n=64) had similar values of BMI (26.7 vs. 26.3 p=0.21), but     statistically significant lower values of waist, glucose, insulin and HOMA-IR, as expected.     When the group non-IR and IR were further stratified by GI diet, there were no differences     according to diet in both groups. Women classified as IR at baseline had greater weight loss     after 12 months of follow-up (-1.62 kg vs. -1.08 kg; p=0.01), and HB exercise helped to     reduce weight only among NIR women (-1.51 vs. -0.68; p=0.04); no differences were observed     between intervention groups for IR women (-1.54 vs. -1.66; p=0.24). There were no differences     between IR and NIR groups for lipid profile after adjustment for weight changes. During     follow-up, changes were more pronounced among those women in the high GI diet. These     differences were statistically significant for weight and BMI and were greater among the IR     compared to the non-IR. Changes in HOMA-IR after 3 months of follow-up were different     comparing non-IR with IR at baseline. The IR had a reduction in the HOMA-IR, whereas in the     non-IR this value increased (-0.73 vs. +0.37; p=<0.001). Also this reduction was greater     among high compared to low GI diet (p=0.04).   "
158719|NCT01206400|"     To study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with     type 2 diabetes mellitus.   "
158720|NCT01206387|"     efficacy study in patients with moderate to severe plaque psoriasis.   "
158721|NCT01206374|"     Vitiligo vulgaris is an autoimmune disorder that causes loss of pigmentation over the skin,     hair and mucous membranes (e.g. lips, nose, genitals). While genes have been identified that     are thought to be required for development of vitiligo, only 5-10% of relatives develop     disease. The triggers for disease onset have not yet been identified. The intent of this     study is to research trends in laboratory data, social and medical history that may be     contributory to vitiligo onset, location of disease, course of illness and response to     therapy.   "
158725|NCT01206322|"     Our goal is to determine the acute effects of intranasal insulin on regional perfusion and     cognition of older adults. We propose a pilot study to examine the effect of a single dose of     intranasal insulin on regional vasoreactivity and cognitive functions in 30 subjects with     T2DM and 30 healthy controls >50 years old using a double blinded, placebo-controlled,     cross-over design.      Hypothesis 1: Intranasal insulin improves acutely regional perfusion and vasoreactivity in     older patients with T2DM as compared with placebo and compared with the control group.      Hypothesis 2: Intranasal insulin improves cognitive functioning including attention, memory     and executive function in diabetic patients as compared with placebo and compared with     control group.   "
158726|NCT01206309|"     The purpose of this research study is to better understand the onset and course of graft     versus host disease (GVHD)and other immune-mediated disorders after stem cell transplant.   "
158727|NCT01206296|"     This is a phase II study evaluating the use of intraperitoneal gemcitabine given     intraoperatively and as adjuvant therapy for patients with resectable pancreas cancer.      The primary objective of this study is to evaluate the overall safety of intraperitoneal     gemcitabine given intraoperatively and postoperatively for adjuvant treatment of resectable     pancreatic adenocarcinoma.      The secondary objectives are to evaluate the efficacy of this treatment regimen as reflected     in overall survival at 2-years, to study the patterns of disease recurrence following this     treatment, to study the pharmacology of intraperitoneal gemcitabine and to study changes in     peritoneal cytology with pancreatic cancer resection.   "
158728|NCT01206283|"     Secondary brain ischaemia (SBI) usually develops after aneurysmal subarachnoid haemorrhage     (SAH) and severe traumatic brain injury (TBI). The current management strategies are based on     intracranial pressure-targeted therapy (ICP-targeted) with cerebral microdialysis monitoring     (modified Lund concept) or cerebral perfusion pressure-targeted therapy (CPP-targeted). We     present a randomised controlled study to compare the two management strategies.      The hypotheses of the study were:        -  SBI developed after aneurysmal SAH and severe TBI share the same crucial characteristics          and any treatment applied will essentially treat the same underlying pathophysiology.        -  ICP-targeted therapy with cerebral microdialysis monitoring according to the modified          Lund concept is superior to CPP-targeted therapy in managing comatose patients with SBI          after aneurysmal SAH and severe TBI.      Sixty comatose operated patients with SBI following aneurysmal SAH and severe TBI were     randomized into ICP-targeted therapy with cerebral microdialysis monitoring and CPP-targeted     therapy groups. Mortality rates in both groups were calculated and biochemical signs of     cerebral ischaemia were analysed using cerebral microdialysis. Outcome for cerebral     microdialysis was measured as poor outcome (Glasgow Outcome Scale score 1, 2 and 3) or good     outcome (Glasgow Outcome Scale score 4 and 5).   "
158729|NCT01206270|"     Patients with infertility often presents alterations at ultrasonographic examination of the     testis. These alterations include a much higher incidence of small, multiple, non-palpable     hypoechoic micro-nodules that can show internal vascularization. This finding often create     alarm and anxiety, because it has to be placed in a differential diagnosis versus low-stage     malignant germ cell tumors. Nevertheless, explorative surgery reveal that a consistent number     of these lesion are benign, due to Leydig cell hyperplasia or Leydig cell tumours. The     purpose of this study is to evaluate the effects of androgen therapy on the size and number     of non-palpable hypoechoic micro-nodules in patients with elevated gonadotropin levels.   "
158730|NCT01206257|"     This study is to collect the information of Ultravist® in the patients indicated for the     coronary angiography or PCI, like rate of ADR in patients, the dose for different     indications, image quality to prove Ultravist the good safety and effectivity   "
158736|NCT01206179|"     Treatment of nonunion, delayed union and malunion fractures of long bones remains     problematic. The definition of nonunion is a failure of the fracture to heal in six months in     a patient in whom progressive repair had not been observed radiographically between the third     and sixth month after the fracture. First of all good surgical techniques are stable     immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is     required. Numerous techniques have been developed ranging from invasive interventions     (including internal fixation with the use of bone graft or bone graft substitutes) to non     invasive procedures (ultrasound and pulsed electromagnetic fields).      Recently, autologous cell therapy was presented as an interesting approach. The concept of     such therapies is based on the effect of stem cells presented in the bone marrow and able to     be transformed in osteoblast cells. The purpose of this study is to find if mesenchymal stem     cells can stimulate bone regeneration in nonunion and delayed union fractures to reduce later     surgeries required to augment the healing process and to accelerate the time to healing.   "
158737|NCT01206166|"     The specific aim of the proposed study is to conduct a pilot study involving 160     critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of     America, Belgium and France in order to:      Specific Aims        -  Confirm that we can achieve a clinically significant difference in calorie and protein          intake between the two intervention groups.        -  Estimate recruitment rate i.e. number of eligible and enrolled patients per month per          site.        -  Evaluate the safety, tolerance, and logistics around providing supplemental PN in the          study population in the context of a multicenter trial, e.g.             -  To ensure adequate glycemic control in both groups.             -  To ensure that the other metabolic consequences of the feeding strategies are               minimized.             -  To establish adequate compliance with study protocols and completion of case report               forms      A secondary aim of this pilot study will be:      • To explore the effect of differential effects of calorie and protein delivery on muscle and     mass function.   "
158738|NCT01206153|"     Antipsychotics such as risperidone could induce amenorrhea in schizophrenic patients. The     investigators conducted a randomized, placebo-controlled study to test the efficacy of     metformin for antipsychotic induced amenorrhea in schizophrenia patients.   "
158739|NCT01206140|"     This randomized phase II trial is studying how well giving selumetinib together with or     without temsirolimus works in treating patients with metastatic, recurrent, or locally     advanced soft tissue sarcoma that cannot be removed by surgery. Selumetinib and temsirolimus     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It     is not yet known whether giving selumetinib together with temsirolimus is more effective than     giving selumetinib alone.   "
158740|NCT01206127|"     Corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by     donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part     (lamellar keratoplasty). One type of lamellar keratoplasty is DSAEK (Descemet's Stripping     Automated Endothelial Keratoplasty), where only the damaged posterior section of the cornea     is replaced.      The purpose of this study is to investigate how immediate postoperative positioning of the     patient affects the dislocation rate of the corneal graft. Since this is a new surgical     method, little scientific documentation has been published in this area.   "
158741|NCT01206114|"     A cohort of 3000 adults is followed to evaluate the effectiveness of the monovalent 2009 H1N1     vaccines used 2009-2010 and seasonal influenza vaccines used 2010-2011 in preventing the     first laboratory-confirmed 2009 H1N1 influenza during the influenza season 2010-11.   "
158742|NCT01206101|"     This trial is conducted in Europe and North America. The aim of this trial is to investigate     if liraglutide treatment can increase the proportion of insulin-independent subjects one year     after islet cell transplantation who required only one (single-donor) islet cell transplant.   "
158743|NCT01206088|"     The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with     Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete     cytogenetic response rate(CCyR) at 12 months after nilotinib administration.   "
158744|NCT01206075|"     Thalassemia is considered the most common genetic disorder worldwide, occurring with high     frequency in Mediterranean areas, the Middle East, Southeast Asia, and the Pacific Islands.     Currently, the only cure for thalassemia is bone marrow transplantation from a related,     compatible donor. Gene transfer, achieved by transplantation of the patient's own blood stem     cells that have been genetically-modified with the corrected gene, could potentially cure     thalassemia.      The first step in developing gene transfer for treatment of thalassemia is to develop a safe     and effective method to obtain blood stem cells from thalassemia patients. Eventually, high     numbers of genetically modified cells will need to be infused into the patient for clinical     gene transfer to be effective. The blood stem cells are obtained by giving a mobilization     agent to the patients. This causes the stem cells to leave the bone marrow and go into the     blood. The purpose of this study is to test the safety and effectiveness of the new     mobilization agent, Mozobil, in causing mobilization of blood stem cells for patients with     beta-thalassemia major.   "
158745|NCT01206062|"     Elevated blood pressure (BP) is an important public health concern. It is highly prevalent,     the prevalence may be increasing, and it is a risk factor for several adverse health     outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease,     and decline in cognitive function. The Systolic Blood Pressure Intervention Trial (SPRINT) is     a 2-arm, multicenter, randomized clinical trial designed to test whether a treatment program     aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended     will reduce cardiovascular disease (CVD) risk.   "
158746|NCT01206049|"     The purpose of this study is to determine the rate of progression free survival of patients     with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are     treated with combination chemotherapy supplemented by biological agents panitumumab or     bevacizumab.   "
158747|NCT01206036|"     In this Phase I study safety of the combination of Docetaxel and Temsirolimus needs to be     shown before the study can be expanded into a Phase II study to examine the activity of a     safe combination of Temsirolimus and Docetaxel in a comparison with Docetaxel alone.   "
158777|NCT01205425|"     The purpose of the study is to determine whether results of the computed tomography coronary     angiography may be helpful in planning and performing percutaneous angioplasty in patients     with stable angina pectoris.   "
158748|NCT01206023|"     Multiple Sclerosis (MS) is a complex multi-factorial disease, with underlying both genetic     and environmental factors. Different populations have different susceptibility. The disease     is characterized by 2 main phenotypes: relapsing-remitting or progressive course. Clinical     disability is due to distraction of the CNS myelin.      Repair processes are mainly noted after the acute attack - and recovery of function can be     spontaneous. However, in severe attacks sometimes there is need for adding STEROID TREATMENT     (6 days IV) for the acute attack.      For the long term prophylactics - following the increased understanding of the disease, in     the last 10-15 years there are new immunotherapies available (COPAXON / TEVA; Interferon     -beta). However these can attenuate the disease (reduce the number of relapses per year) but     are not cure. Also, they are beneficial in only ~40 % of the Relapsing -Remitting patients.      Currently there are no biomarkers available for MS (other than oligoclonal IgG in the CSF -     which help confirm diagnosis but require invasive procedure and are not correlated with     disease activity nor response to therapy) and - monitoring of MS and its treatment is by MRI     - which is expensive.      Dr Hossam Haick from the Technion developed an electronic nose based nanomaterials for     diagnosis of diseases (e.g., cancer, kidney failure, etc.) via breath samples.The research     hypothesis is that Biomarkers of CNS inflammation and/or neurodegeneration and/or CNS repair     can be detected by electronic nose.   "
158749|NCT01206010|"     Varenicline is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors. It     is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of     cigarettes. The standard varenicline dosing has been formulated to avoid adverse reactions     (primarily nausea) in sensitive clients. The downside of this cautious approach is that a     substantial proportion of clients may be under-dosed. A blanket dose increase would     inevitably increase the incidence of side effects, but it is likely that tailoring     varenicline dosing to clients' needs would be safe and may further increase varenicline's     efficacy.      This study will recruit 200 smokers who report little change to their enjoyment of cigarettes     and no nausea, during the first week of varenicline use. These smokers will be randomised to     receive the standard dose plus placebo or plus individualised varenicline dose up to 5mg,     titrated over the next week prior to their target quit day. Urges to smoke, and other     withdrawal symptoms, experienced during the study period will be compared between groups to     see if the tailored therapy may be useful.   "
158759|NCT01205659|"     Allergy and Asthma study of children (3 - 7 Years of age) who participated in randomized     trials of supplemented infant formula during infancy conducted by The Retina Foundation of     the Southwest .   "
172606|NCT00102440|"     The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily     (QD), versus allopurinol in subjects with gout.   "
158750|NCT01205997|"     Magnesium has been suggested that NMDA (N-methyl D-aspartate)receptor antagonists induce     preemptive analgesia when administrated before tissue injury , thus decreasing the subsequent     sensation of pain.      Following Ethics Committee approval and informed patients consent, Ninety patients 20-60 yr     old ASA physical status I or II, scheduled for femur surgery under spinal anesthesia, were     studied in a prospective, double-blinded, randomized way. The patients were randomly     allocated to one of three groups of 30 each. The magnesium group (groupM) received     bupivacaine 15mg combined with 0.5ml magnesium 10%,the fentanyl group (group F) received     bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and the placebo group (group P)     received bupivacaine 15mg combined with 0.5ml distilled water intrathecally . Time to first     requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset     of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension,     ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen (SpO2)<90],     postoperative analgesic requirements and Adverse events, such as sedation, dizziness ,     Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed     preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum     imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a     supplement analgesic, methadon5 mg intravenously , was to be given for post-operative pain     relief as needed .   "
158751|NCT01205984|"     The place of systemic corticosteroids in the treatment of children with chronic     rhinosinusitis (CRS) remains unclear. We aimed to assess the effectiveness and tolerability     of oral methylprednisolone (MP) as an anti-inflammatory adjunct in the treatment of CRS in     children.Forty-eight children (age 6-17 years) with clinically and radiologically proven CRS     were included. Patients were randomly assigned to either oral amoxicillin/clavulanate (AMX/C)     and MP or AMX/C and placebo (P) twice daily for 30 days. Oral MP was administered for the     first 15 days with a tapering schedule. Primary parameters were mean change in symptom and     sinus computed tomography (CT) scan scores after treatment. Secondary study parameters were     mean changes in individual symptom scores after treatment, relapse rate and tolerability.     Forty-five patients completed the study, 22 received AMX/C and MP, and 23 AMX/C and P. Both     groups demonstrated significant improvements in symptom and sinus CT scores, comparing     baseline to end of the treatment (p<0.001). Methylprednisolone as an adjunct was     significantly more effective than placebo in reducing CT scores (p=0.004), total     rhinosinusitis symptoms (p=0.001) and individual symptoms of nasal obstruction (p=0.001),     postnasal discharge (p=0.007), and cough (p=0.009). At the end of the treatment, 48% of the     children in the P group still had abnormal findings in CT versus 14% in the MP group (p =     0.013). Therapy-related adverse events were not different between groups. Although     insignificant, the incidence of clinical relapses was also less in the MP group (25%)     compared to P group (43%) (p = 0.137). Oral MP is well tolerated and provides added benefit     to treatment with antibiotics for children with CRS.   "
158752|NCT01205971|"     Dental caries is the most common chronic disease of childhood and is increasing in prevalence     in children 2-5 years old. Racial and ethnic minority groups as well as economically     disadvantaged individuals are affected the most by this health outcome. This study will test     if a community-based multimodal intervention will reduce 2-year incidence of early childhood     caries (ECC) in children aged 0-5 living in public housing developments. The intervention     combines the components of motivational interviewing (counseling) delivered by dental health     advocates, fluoride varnish application, oral health assessment and referral. The     investigators hypothesize that the multimodal intervention with motivational interviewing     will reduce ECC behavioral risk factors thereby leading to a reduction of ECC incidence when     compared to fluoride varnish application, written oral health education materials and oral     health assessment and referral.   "
158753|NCT01205958|"     The purpose of this study is to assess the effect of East-West collaborative medicine on     chronic cervical pain.   "
159980|NCT01189513|"     The goal of this clinical research study is to find the highest tolerable dose of SCH 900105     that can be given to patients with glioblastoma before surgery. The safety of this drug will     also be studied.   "
158754|NCT01205724|"     This trial is conducted globally. The aim of this clinical trial is to investigate the safety     and pharmacokinetics (the determination of the concentration of the administered medication     in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe     haemophilia A.   "
158755|NCT01205711|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, and     leucovorin calcium, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Zibotentan may be effective in treating     metastatic colorectal cancer that has not responded to oxaliplatin. It is not yet known     whether combination chemotherapy is more effective when given with or without zibotentan in     treating metastatic colorectal cancer.      PURPOSE: This randomized phase II trial is studying giving irinotecan hydrochloride together     with fluorouracil and leucovorin calcium to see how well it works when given with or without     zibotentan in treating patients with metastatic colorectal cancer.   "
158756|NCT01205698|"     This clinical trial will determine the effect of varying types of carbohydrates contained in     milk-based beverages on the glycemic response and GI values.   "
158757|NCT01205685|"     Erlotinib attacks a part of cancer cells that helps them live and grow. Studies done in human     beings show that this drug can make a difference in the way anti-estrogens work in     hormone-sensitive breast cancers. OSI-906 attacks a different part of the cancer cell that     helps them live and grow. Studies done in the laboratory show that OSI-906 can make a     difference in the way anti-estrogens work in hormone-sensitive breast cancers.   "
158758|NCT01205672|"     The goal of this research study is to learn if metformin can affect endometrial cancer cells     in women who do not have diabetes.      Objectives:      Primary Objectives:      1. To determine the molecular effects of metformin and associated physiologic changes in     insulin/glucose metabolism on the mTOR (mammalian target of rapamycin) signaling pathway in     the endometrium of women with endometrial cancer      Secondary Objectives:        1. To describe the effects of metformin on the histology and proliferation of the          endometrium in women with endometrial cancer.        2. To assess the effect of body mass index on the response to treatment with metformin        3. To assess the effect of insulin resistance on the response to treatment with metformin        4. To determine effects of metformin on the serum, urine and DNA biomarkers of women with          endometrial cancer.   "
158760|NCT01205646|"     The primary goal for this trial is to assess the change in PET scans with the administration     of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It has     been established that zoledronate therapy may play a role in delaying and reducing the     incidence of skeletal events. Researchers propose to evaluate the change in the uptake value     of FMAU PET scan after the zoledronate therapy. It has been demonstrated that FMAU PET scans     can successfully demonstrate and detect bony metastatic sites in prostate cancer.      In addition, investigators would like to evaluate the change in the level of the     prostate-specific antigen (PSA) in the patient as well as outcome of bone scans.   "
158761|NCT01205633|"     Patients suspected of CCSVI (chronic cerebrospinal venous insufficiency) may be tested and if     appropriate treated with catheter venoplasty by an interventional radiologist in their local     community who has been credentialled either by the local hospital's IRB or a national IRB if     the procedure is done in an outpatient facility. Catheter angioplasty is a long-established     and accepted medical procedure, patients' insurance should but may not cover the testing or     treatment.   "
158762|NCT01205620|"     Participants undergoing Off-CABG will be randomized 1:1 to one of the following groups:        -  treatment with CirQlator TM Intrathoracic Pressure Regulator (ITPR)        -  no ITPR .Anesthesia will be standardized for both groups. The groups will be compared          based on the differences in vasopressor use, the number and amount (in milliliters) of          intravenous fluid boluses required and hemodynamic changes noted, including systemic          blood pressure, pulmonary arterial pressure, pulse pressure, heart rate (recorded most          reliably from the arterial line), cardiac output (CO), cardiac index (CI), mixed venous          oxygen saturation (SVO2), SVR, pulmonary vascular resistance (PVR), and stroke volume          (SV).      Specifically, we will compare the groups based on the mean number of intravenous fluid     boluses, mean amount of norepinephrine and epinephrine infusion required, the number of     recorded systolic blood pressures < 90 mmHg, and number of CI < 2.0 L/min/m2. We will also     compare the number of times the surgeon must reposition the heart for treatment of     hypotension, and ascertain whether the ITPR will help patients tolerate the cardiac     displacement better, thus decreasing the time required to complete the bypass graft     anastamosis. ECG will be monitored intraoperatively for signs of ischemia including ST     changes, greater than 1mm depression or elevation. Postoperatively, we will record the need     for and amount of diuretic required.      We hypothesize that in this pilot study, patients undergoing OPCAB who are treated with     CirQlator TM Intrathoracic Pressure Regulator (ITPR) will achieve higher blood pressures and     cardiac output and require less intravenous fluids and vasopressor administration than     patients managed without the ITPR.   "
158763|NCT01205607|"     Patients who have a functioning intracranial pressure-monitoring device (either a     subarachnoid bolt, or an intraventricular catheter) in place, and are either sedated,     intubated, and mechanically ventilated (i.e. in the NNICU), or are scheduled to undergo an     operation or interventional neuroradiological procedure at the University of Virginia.     Patients with a contraindication to TTE will be excluded.      For patients in the NNICU, basic hemodynamic variables (systemic blood pressure, central     venous pressure, etc.) will be collected. In addition, left ventricular performance     (including estimates of LVEDV, LVESV, EF, FAC, and SV) will be assessed using TTE. Once these     baseline data are recorded, the ITPR will be inserted in the ventilator circuit and activated     to provide either -5 mm Hg or -9 mm Hg endotracheal rube pressure (ETP) (based on a     randomization scheme). After the ITPR has been active for at least five minutes, the same     intracranial, hemodynamic, and TTE data obtained above will be gathered. The ITPR will then     be turned off for five minutes, and intracranial, hemodynamic, and TTE data will again be     recorded. The ITPR will be activated a second time (-9 mm Hg or -5 mm Hg ETP, i.e. whichever     value was not used previously), and after five minutes of use data will be recorded again.     The ITPR will then be disconnected, data will be collected after waiting two minutes, and no     further interventions will be made.      ABG's will be obtained before and during the use of the device at each setting.      This is a proof of concept/feasibility study designed to test the primary hypothesis that use     of the ITPR will result in decreased intracranial pressure and increased cerebral perfusion     pressure. The effect of the ITPR on secondary indicators of cardiac performance will also be     examined. These include but are not limited estimates of ventricular end diastolic volume and     pressure (LVEDV/P), ejection fraction (EF), left ventricular end systolic volume and pressure     (LVESV/P), fractional area change (FAC), all of which will be assessed by transthoracic     echocardiography (TTE) or transesophageal echocardiography (TEE).   "
158764|NCT01205594|"     Briefly, after the induction of anesthesia and the placement of TEE, hemodynamic variables     (pulmonary and systemic blood pressure, central and pulmonary venous pressure, cardiac     output, calculated SVR, etc.) will be collected. In addition, left ventricular performance     (including estimates of LVEDV, LVESV, EF, FAC, etc.) will be assessed using TEE. Once these     baseline data are recorded, the ITPR will be inserted in the anesthesia circuit and activated     to provide -9 mmHg ETP. After the ITPR has been active for at least two minutes, the same     hemodynamic and TEE data obtained above will be gathered. After the data is recorded, the     ITPR will be disconnected and no further interventions will be made. In addition to the     hemodynamic and echocardiographic data described above, an arterial blood gas will be     obtained from the pre-existing radial artery catheter during the on- and off- states.      Finally, the TEE examination will be recorded on videotape or DVD. A second     echocardiographer, blinded to patient and ITPR status will review each echocardiogram and     assess left ventricular performance. In addition to the data derived at the time of testing,     the second echocardiographer will assess, if possible, changes in EF using Simpson's method     of disks is used to calculate the LV volume.      This is a proof of concept/feasibility study designed to test the primary hypothesis that use     of the ITPR will result in increased systemic blood pressure and cardiac output in patients     undergoing CABG surgery. The effect of the ITPR on other secondary indicators of cardiac     performance will also be examined. These include but are not limited to left ventricular end     diastolic volume (LVEDV), ejection fraction (EF), left ventricular end systolic volume     (LVESV), and fractional area change (FAC) as assessed by echocardiography, pulmonary artery     pressure, and calculated systemic vascular resistance (SVR).   "
158765|NCT01205581|"     This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated     influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or     HIV will be vaccinated twice with one of the two vaccines and evaluated for development of     immune responses.   "
158766|NCT01205568|"     The primary objective of this study is to evaluate the safety and efficacy of transcatheter     Cutting Balloon therapy for branch pulmonary artery stenosis resistant to low pressure     dilation.   "
158767|NCT01205555|"     Intra-uterine insemination (IUI), generally in combination with ovarian stimulation, is one     of the most commonly used treatments for infertility. Accurate timing of insemination, in     order to coincide with ovulation, has an important impact on the success rate. Optimal timing     of insemination is achieved either by monitoring follicular growth through serial ultrasound     measurements followed by the administration of human chorionic gonadotropin (hCG) or by the     detection of urinary luteinizing hormone (LH). However in cycles where follicular growth is     monitored there is a possibility of premature LH rise before the administration of hCG, which     may affect the outcome of the treatment. The goal of the study is to determine if adding the     testing of urine LH in conjunction with ultrasound monitoring leads to an increase in     pregnancy rates in IUI cycles when compared to ultrasound monitoring alone.   "
159361|NCT01197716|"     The Chest Pain Unit (CPU) register is a nationwide scientific investigation, in which data     concerning the hospital-stay within the Chest Pain Unit are documented. Furthermore, a     Follow-up via telephone is conducted after 3 months.   "
158768|NCT01205542|"     Basic strength training for the neck/shoulder muscles can decrease intensity of neck/shoulder     pain, but it is uncertain whether training should focus directly on the upper trapezius -     which is most often tender - or on the lower compartments and serratus anterior.      We hypothesize that strengthening exercise for the lower and middle trapezius as well as the     serratus anterior will decrease intensity of neck/shoulder pain among office workers   "
158769|NCT01205529|"     The purpose of this study is to look for a similarity in people's genes that may help     understand which people could benefit from certain drugs for the treatment of atrial     fibrillation.   "
158770|NCT01205516|"     INTRODUCTION: There is an important need for inexpensive drugs that treat neuropathic pain.     Early research suggests that methadone may be a good, inexpensive drug to treat neuropathic     pain. Methadone is available in a low cost powder that is easily prepared for different     routes of administration. This study will look at the effect and safety of methadone compared     to the regular treatment of morphine for the treatment of chronic neuropathic pain.      OBJECTIVES: First the investigators want to determine if methadone is effective and safe for     the treatment of neuropathic pain. Since a placebo control group would be unethical, the     proposed comparator will consist of the gold standard conventional treatment, controlled     release morphine. The investigators will compare methadone to controlled-release morphine     with regard to how it affects the level of pain and extent of side effects. Next the     investigators want to examine safety as well as to determine whether methadone leads to     improvements in physical and emotional functioning, and participants' satisfaction with the     treatment.      METHODS: A double blind, randomized trial comparing methadone and controlled release morphine     is proposed. After 1-week, participants will be randomly assigned to either methadone or     controlled release morphine and will gradually build to a dose at which they receive adequate     pain relief without unacceptable levels of side effects. This 5-week phase will be followed     by a 6-week dose phase and then a 4-week tapering off phase.      Study drug: The study drug is methadone supplied in 2.5 mg tablets. The comparator will     consist of controlled release morphine in 10 mg tablets. The dose of each will range from     1-12 tablets taken every 12 hours (dose ranges methadone 5-60 mg/day, controlled release     morphine 20-240 mg/day).      Setting: This is a 3-site study involving pain clinics in Halifax, Nova Scotia; London,     Ontario; and Calgary, Alberta.   "
158771|NCT01205503|"     The purpose of this study is to determine whether the drug mesna is able to block a series of     chemical changes that occur in the blood of patients who receive the chemotherapy medicine     doxorubicin. The researchers believe these blood chemical changes may the cause of cloudy     thinking or chemobrain that are reported by some patients receiving chemotherapy.   "
158772|NCT01205490|"     The investigators are performing a study to determine whether changes in blood flow occur in     the neck and back of the brain following a series of head positions and a manipulation of the     upper neck. Each participant will be asked to undergo a series of MRI's to evaluate whether     there are any changes in blood flow resulting from any of the head positions or manipulation.     The study will be conducted over a period of 1 day and each participant can anticipate the     testing to take approximately 120 minutes.   "
158773|NCT01205477|"     To investigate the safety and efficacy of methylprednisolone infiltration in anserine     bursitis treatment   "
158774|NCT01205464|"     The aim of this randomised, double-blind crossover study was to determine whether Doxycycline     has an impact on the persistent symptoms post-neuroborreliosis, through alterations in the     immune response and whether such an effect could influence the clinical outcome.   "
158775|NCT01205451|"     This trial is a multicenter, open-label study to evaluate the safety and efficacy of     GSK1358820 for treatment in post-stroke subjects with focal wrist, finger and in some cases,     thumb spasticity. Qualified patients who complete GSK double-blind study 112958 will be     enrolled. Subjects will receive a single treatment session of intramuscular GSK1358820 200U     or 240U (if thumb spasticity is present). The subjects will be observed until 12 weeks post     injection. Outcome measures include changes from baseline at every post injection visit as     measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global     Assessment Scale. Safety parameters will be measured including adverse events, vital signs     (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and     urinanalysis).   "
158776|NCT01205438|"     The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two     different doses of LY2127399 administered in addition to standard of care therapy in patients     with active SLE.   "
175022|NCT00132678|"     The purpose of this study is to determine if risperidone is effective and safe in the     prevention of mood episodes in patients with bipolar 1 disorder.   "
158779|NCT01205399|"     This study will enroll subjects who underwent a ventral hernia repair using the AlloMax     Surgical Graft at least 9 months in the past.      All subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least     9 months in the past will be contacted and asked to take part in this clinical study. The     consented subjects' medical records will be reviewed for evidence of any risk factors of     hernia recurrence, procedure time, complications and any documented recurrences. The subjects     will be asked to undergo a physical exam to rule out any recurrences that were not documented     in the medical records.   "
158780|NCT01205386|"     The purpose of this study is to determine if the CROSSER CTO Recanalization System can     facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the     Superficial Femoral Artery (SFA). A Chronic Total Occlusion (CTO) is defined as 100%     narrowing of the artery, with no angiographically detectable antegrade blood flow, and the     assessment that the lesion has been in existence for a minimum of 30 days. This study will     enroll up to 100 patients at up to 8 clinical sites. The CROSSER CTO Recanalization System     was cleared for commercialization by the US Food & Drug Administration. This study also     involves an imaging device called the IVUS (Intravascular Ultrasound Imaging) catheter. This     device has been cleared for commercialization by the US Food and Drug Administration and will     be studied for its cleared intended use. The IVUS catheter is used to generate real-time     images of the artery, which will allow for evaluation of the artery after the occlusion is     crossed. This is a post-market registry.   "
158781|NCT01205373|"     The main objectives of the present study are to investigate the basic pharmacokinetics of BI     671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance, excretion     pathways and metabolism following a single oral dose of 400 mg [14C]BI 671800 HEA to healthy     male volunteers. Secondary objectives are to evaluate the safety and tolerability following a     single oral dose of 400 mg [14C]BI 671800 HEA to healthy male volunteers.   "
158782|NCT01205360|"     The purpose of this study is to determine how manipulation of the programmed intermittent     time interval and volume influences total drug use, quality of analgesia, and patient     satisfaction during maintenance of labor analgesia.   "
160780|NCT00000217|"     The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine     craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric     disorders.   "
158783|NCT01205347|"     Stress hyperglycemia during myocardial infarction (MI) is related to mortality at short and     long term. Recent studies, however, revealed that chronic statin treatment may decrease both     insulin sensitivity and secretion immediately after statin therapy initiation. This study aim     was to investigate the dose-dependent effect of statins on insulin sensitivity in patients in     the acute phase of MI.   "
158784|NCT01205334|"     Patients have a type of brain cancer called glioblastoma multiforme. Because most GBMs come     back after standard therapy, patients are being asked to volunteer to take part in a research     study using special immune cells. They may have already thought about being in this study.      Some patients with GBM show evidence of infection with a virus called Cytomegalovirus before     the time of their diagnosis. CMV is found in the cancer cells of some patients with GBM,     suggesting that it may play a role in causing the disease. The cancer cells infected by CMV     are able to hide from the body's immune system and escape destruction. We want to see if     special white blood cells, called T cells, that have been trained to recognize and kill     special parts of CMV infected cells can survive in the blood and affect the tumor.      We have used this sort of therapy to treat different types of cancer that are positive for     other viruses and have had variable results. Some patients have had responses others did not.     It is not possible for us to predict if this treatment will work for GBM.      The purpose of this study is to find the largest safe dose of CMV-T cells, to learn what the     side effects are, and to see whether this therapy might help patients with GBM.   "
158785|NCT01205321|"     Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography)     images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.   "
158786|NCT01205308|"     In type 1 diabetes (T1D) coronary artery disease (CAD) is an important cause of morbidity and     mortality. Although serum cholesterol concentrations are not always elevated in T1D,     cholesterol metabolism is different from non-diabetics, so that cholesterol absorption is     enhanced. The aim of this study is to investigate the effects of plant stanol esters on serum     lipid and lipoprotein lipid concentrations, plant sterol and cholestanol concentrations as     well as cholesterol metabolism in T1 diabetics on statin use. The study will give new     information about how addition of plant stanol esters on statin use improve hypolipidemic     effects in type 1 diabetes.   "
158787|NCT01205295|"     Background: Previous studies have shown that anxiety and dissatisfaction with patient     progress are predictors for increased postoperative pain and reduced impact and efficacy of     pain treatment. However, it remains to be shown whether patient anxiety and concern are     predictors for the perceived quality of patient progress and the perceived efficacy of     treatment.      The aim of this study is to investigate whether there is a correlation between preoperative     anxiety and concern, and the perceived quality and efficacy of postoperative treatment. The     hypothesis is that anxious and concerned patients are less satisfied with treatment and have     a poorer response of their treatment.      Methods/design: This PhD-project consists of four coherent studies. 1) A methodological study     evaluating the CMD-SQ (Common Mental Disorder - Screening Questionnaire) questionnaire by a     test-retest study. 2) The main study, a prospective follow-up study, has the aim of     investigating the correlation between patient anxiety and concern, their perceived quality of     patient progress and the perceived efficacy of treatment. This correlation will be detected     by means of five questionnaires: CMD-SQ, EQ-5D, SF-12, HVOK, OHS or OSS. 3) A study     consisting of an explicit internal medical audit with the aim to investigate whether the     medical assessment of patient efficacy of treatment is consistent with their own     self-reported efficacy of treatment. 4) An intervention study designed as a randomized     clinical trial. The aim is to investigate whether a targeted effort towards patients with a     high score of CMD-SQ, i.e. patients with anxiety and concern, can increase their     self-reported efficacies of treatment and their perceived quality of progress. A total of 800     hip- and shoulder-patients will be included.      Discussion: If a correlation between patient anxiety and concern, their perceived quality of     progress and the perceived efficacy of treatment is found, it will be relevant to screen all     hip- and shoulder-patients for anxiety and concern preoperatively and deal with this before     their operation. This study will provide a proposition of how these patients can be taken     care of through cognitive behavioural therapy as a targeted effort towards their anxiety and     concern.      Aim and hypothesis: The aim of this study is to investigate whether there is a correlation     between patient anxiety and concern, and their perceived quality and efficacy of treatment.     The overall hypothesis is that patients who are anxious and concerned are less satisfied with     their treatment and have a poorer overall efficacy of their treatment.   "
158788|NCT01205282|"     The investigators propose a pilot, single blind, placebo run-in, dose finding study of     pioglitazone in children with autism with the ultimate goal of identifying appropriate dosing     and outcome measures for a larger follow-up randomized placebo controlled clinical trial. The     specific aims of this study are: 1) To examine the safety of pioglitazone in children with     autism spectrum disorders (ASD) ages 5-12 years; 2) To identify appropriate outcome measures     to be used in a follow-up multisite randomized control trial of pioglitazone in children with     ASD; 3) To determine the maximum tolerated dose to be used in the follow-up multisite     randomized controlled trial; 4) To examine the effect of pioglitazone on markers of     inflammation (cytokine levels) and oxidative stress (superoxide dismutase, malonyl     aldehydes); 5) To explore the relationship between different doses and response to treatment.   "
158790|NCT01205256|"     This is a pilot study to determine the pharmacokinetics of (R,S) methadone in adolescents. A     total of approximately 15 patients will be required. The purpose is to determine the levels     of R, S methadone at various time intervals after drug administration. Patients will receive     methadone 0.25 mg/kg IV at induction and a standardized anesthetic of remifentanil and     propofol. At the conclusion of surgery (45 minutes prior to the completion), the patients     will receive a loading dose of morphine based on respiratory rate. A morphine PCA will be     utilized for postoperative analgesia. Pharmacokinetic data will be collected in addition to     VAS scores, patient and parental satisfaction with analgesia, and a functional pain     assessment.   "
158791|NCT01205243|"     An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor     the safety and efficacy of ZIAGEN® administered in Korean patients according to the     prescribing information.   "
158792|NCT01205230|"     The purpose of this study is to determine how dosing with ketoconazole (Nizoral) or     esomeprazole (Nexium) affects the pharmacokinetics of oral pazopanib. The study will also     test for safety of pazopanib when administered with ketoconazole or esomeprazole.   "
158811|NCT01204970|"     Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive     pulmonary disease (COPD) and lung transplant recipients is described and will be correlated     with clinical findings in order to described small airway remodelling in these patients.   "
158812|NCT01204957|"     Japanese postmenopausal women in Japan have about one ninth the rate of American     postmenopausal women. Rates of breast cancer double even after just ten years among Japanese     women who migrate to the US. Diet is thought to be an important factor, and the investigators     were interested in whether dietary seaweed, with and without soy supplements, could influence     known biomarkers of breast cancer risk in American women.   "
158813|NCT01204944|"     The Swiss Transplant Cohort Study is an observational prospective cohort study enrolling all     patients after solid organ and stem cell transplantation since 5/2008 in Switzerland.     Predefined variables are collected at defined time points. Individual samples (PBMC, plasma,     DNA) will be stored for future projects. Data relevant to transplantation outcome with     emphasis on immunological and infectious complications as well as psychosocial variables will     be gathered.   "
158793|NCT01205217|"     This study will test the safety of a drug called lapatinib and how well it works. Lapatinib     (also called Tyverb or Tykerb) will be compared with another drug trastuzumab (also called     Herceptin).      Trastuzumab is an antibody against the HER2 protein. It binds to part of the HER2 protein to     stop it working. Clinical trials have found that adding trastuzumab to chemotherapy lowers     the rate of cancer recurrence and improves survival in women with HER2 positive breast     cancer.      Lapatinib also stops the HER2 protein working and may slow or stop cancer cells from growing     and may prevent cancer from returning. Lapatinib has been approved in some countries to treat     patients with certain types of breast cancer. However lapatinib has not been approved to     treat early breast cancer. This study is one of many being carried out involving lapatinib in     early breast cancer and these studies are showing that it is a promising treatment.      This study will compare lapatinib and trastuzumab. One group of people will take lapatinib     and another group will take trastuzumab. The effects of the drugs, both good and bad, will be     compared. This study will compare two different durations of HER2 treatment to see if earlier     introduction of HER2 treatment is beneficial. The lapatinib group will receive HER2 treatment     from the very beginning for 24 weeks prior to surgery and the trastuzumab group will only     receive HER2 therapy for 12 weeks prior to surgery.   "
158794|NCT01205204|"     The purpose of this study is to evaluate the safety, quality and duration of block with the     addition of Clonidine in different doses to 0.5% heavy bupivacaine, and to compare it with     addition of Fentanyl to 0.5% heavy bupivacaine in sub- arachnoid block.   "
158795|NCT01205191|"     Definitions      CBT-ubiquitous - Cognitive behavioural therapy (CBT) provided with all-time (ubiquitous)     support by cell phone applications CBT-TAU - Cognitive behavioural Therapy provided 'As     Usual' CBT-placebo - Cognitive behavioural therapy provided with access to a digital audio     player with self-administered materials for stress management and relaxation.      Study objectives        1. to compare the relative effectiveness of a computerized ubiquitous CBT (CBT-ubiquitous)          against anxiety disorders with CBT-treatment as usual (CBT-TAU);        2. to assess the safety and tolerability of the CBT-ubiquitous as compared with CBT-TAU and          CBT provided with access to a placebo technical device (CBT-placebo)..      Study implementation      The investigators hypothesize that all active treatments are superior to placebo given     evidence that face-to-face CBT is effective in the treatment of both anxiety and depression.     The investigators also predict that patients receiving CBT-ubiquitous will show greater     improvement than those given CBT-TAU, and assume that CBT-ubiquitous leads to improved     adherence with treatment compared to CBT-TAU and CBT-placebo.      The investigators will use an intention to treat (ITT) approach to fulfill the study aims, by     which the investigators mean that clients are analysed as randomized rather than by treatment     actually received. The study will be implemented in the central district of Östergötland     County Council (pop 145.000). The research group has in two previous projects (VINNOVA     2005-2007, VINNOVA 2008-2009) established cooperation with the 'Unga Vuxna' (Young Adults)     service provided in this district. The service supplies CBT to the subpopulation experiencing     early stages of mental disorders in the age group 16-25 years (n=20,000) in order to prevent     development of significant psychiatric disease and disability. The service employs six     therapists with at least one year specific CBT training and is co-located with Primary     Healthcare Centres (PHCs) in downtown Linköping, Åtvidaberg and Kisa. Clients staying outside     the urban areas can make appointments with therapists at their closest PHC on a weekly basis.   "
158796|NCT01205178|"     SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed     by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and     Medicines for Malaria Venture (MMV). TQ is currently being developed for the radical cure of     acute P. vivax malaria in combination with standard doses of CQ, which is 1500 mg over 3     days.      The current gold standard for radical cure of P. vivax malaria in many areas of the world is     chloroquine (CQ) for clearance of the acute parasitemia immediately followed by primaquine     (PQ) to clear the liver stages of the parasite and prevent disease relapse. The 8-AQ class of     drugs, including PQ, is hemolytic in subjects with glucose-6-phosphate dehydrogenase (G6PD)     deficiency. The current study will identify a dose of TQ within the target efficacious dose     range that has a hemolytic effect similar to or less than PQ 15 mg OD x 14 days (i.e. ≤     25-30% hemoglobin decline in WHO class III G6PD-deficient subjects).   "
158797|NCT01205165|"     Objective(s) The primary study objective is to assess the antiviral effect of 12 weeks of     adefovir dipivoxil treatment in Korean patients with chronic hepatitis B and compensated     liver disease. The secondary study objectives are to assess the antiviral effect, clinical     benefit and safety of 52 weeks of adefovir dipivoxil treatment.      Endpoint(s) The primary efficacy endpoint is Mean log10 reduction in serum HBV DNA level     from baseline to Week 12.      The secondary efficacy endpoints include (a) the proportion of patients achieving serum ALT     normalization at Week 52, (b) other assessments of antiviral effects (the proportion of     patients achieving HBV DNA no less than 300 copies per mL at Week 52), (c)HBeAg loss, HBeAg     seroconversion, HBsAg loss and HBsAg seroconversion, (d)the proportion of patients achieving     serum ALT normalization at Week 12.      Study Design This is an open label, multi centre phase IV study for Korean patients with     chronic hepatitis B and compensated liver disease, assessing the antiviral effect of 12 weeks     treatment of Adefovir dipivoxil as a primary objective and antiviral effect, clinical benefit     and safety of 52 weeks treatment as secondary objectives.      Patients will be screened for eligibility criteria and the baseline visit for the treatment     initiation should occur no more than 4 weeks after screening. Total treatment period will be     52 weeks and patients will return to the clinic for assessments as scheduled during treatment     period. After the 52 week study period, it is likely that the patient will benefit from     continued treatment with commercial adefovir. If in the investigator's clinical judgement     this is the case, the investigator should ensure that a routine prescription is available in     a timely manner, and that no unnecessary interruption in treatment occurs.      Study Population A minimum of 100 male or female Korean patients more than 18 years of age     with HBeAg positive chronic hepatitis B and compensated liver disease who meet the     eligibility criteria will be enrolled.      Study Assessments and Procedures      Potential patients will be screened prior to study entry and eligible patients who have given     their consent will have further baseline assessments. Following the screening, the first     doses of study medications will be given at baseline and patients will return to the clinic     for assessment as scheduled during treatment period. Patients who discontinue treatment     prematurely will be followed up every 4 weeks for 12 weeks following the withdrawal visit.     The following key assessment and or measurement will be made at one or more visits during the     study. (See section 14.1 Appendix 1. Time and event schedule):        -  Pregnancy test (females of child-bearing potential only)        -  Haematology and serum chemistry profile including prothrombin time(PT) and AFP        -  HBV DNA (Roche COBAS AMPLICOR HBV MONITOR Test, LLOD 300 copies per ml)        -  Hepatitis B markers: HBeAg(Anti HBe will be tested if HBeAg is negative), HBsAg(Anti HBs          will be tested if HBsAg is negative) Investigational Product(s) Adefovir dipivoxil 10mg          tablets will be supplied by GlaxoSmithKline and presented as a white to off white, round          tablets, packaged in the bottle containing 30 tablets   "
158799|NCT01205139|"     The purpose of this study is to investigate the effect of steady-state concentrations of     TMC435 on the steady-state pharmacokinetics of TMC278 or Tenofovir , and vice versa. Steady     state is a term which means that the drug has been given long enough so that the plasma     concentrations will remain the same with each subsequent dose. TMC435 is being investigated     for the treatment of chronic hepatitis C virus (HCV) infection. TMC278 and Tenofovir are two     antiretroviral drugs for treatment of human deficiency virus (HIV) infection.     Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the     body and eliminated from the body.   "
158800|NCT01205126|"     The purpose of this study is to compare the safety and efficacy of Oral Osmotic Therapeutic     System (OROS) hydromorphone hydrochloride (HCl) with controlled-release oxycodone HCl in     participants with cancer-related pain.   "
158824|NCT01204801|"     The purpose of this randomized Phase III study is to determine whether preoperative focused     microwave heat treatment and chemotherapy combined are more effective than preoperative     chemotherapy alone in the treatment of large breast cancer tumors in the intact breast.     Combining heat with chemotherapy before surgery might shrink the tumor so that it can be     removed in a breast conserving surgery (lumpectomy) instead of a mastectomy.   "
158801|NCT01205100|"     Background: Abdominal bloating is a frequent and bothersome complaint in patients with     functional gut disorders without satisfactory treatment to date. Recent data from our     laboratory indicate that abdominal distention in these patients is produced by     abdomino-phrenic dyssynergia: diaphragmatic contraction associated with abdominal wall     relaxation (particularly the internal oblique). In analogy to other clinical situations (e.g.     functional outlet obstruction, rumination or aerophagia) behavioral treatment by means of     biofeedback might be equally effective in these patients. The investigators hypothesized that     abdomino-phrenic coordination and abdominal distention can be controlled by biofeedback     techniques.      Aim: to prove the efficacy of behavioural treatment using biofeedback techniques for     abdominal distension.      Randomization: Patients will be randomized into biofeedback and placebo groups.      Intervention. Biofeedback: patients will be taught to control abdominothoracic muscular     activity by bio-feedback using online electromyography information. Placebo: patients will be     given a pill containing placebo medication. Interventions will be delivered in 3 sessions (20     min each) over 10-day period      . Measurements: Sensation of abdominal distension will be assessed by means of graphic rating     scales graded from 0 (no perception) to 6 (very intense sensation). The activity of the     abdomino-thoracic muscles will be recorded. Abdominal distension will be measured by a metric     tape fixed to a non-stretch belt placed over the umbilicus.      Outcomes: Primary outcome: Change in sensation of abdominal sensation. Secondary outcomes: a)     changes in thoraco-abdominal activity of the muscular walls; activity of thoraco-abdominal     muscles (intercostals, diaphragm, external oblique, internal oblique, upper rectus, lower     rectus) will be measured by electromyography; b) changes in girth; abdominal girth will be     measured using a nonstretch belt (48mm wide) that is placed over the umbilicus. The     overlapping ends of the belt will be adjusted carefully with two elastic bands to adapt     constantly to the abdominal wall.   "
158802|NCT01205087|"     This clinical study is designed to evaluate the safety and immune modulatory effects of oral     administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the     metabolic syndrome.   "
158803|NCT01205074|"     Several factors will be tested to see if they have an influence on the methacetin breath test     results. Each one of the factors has been raised as a possible source of distortion of the     MBT result.      I. Variability between same tests on same subject MBT. Repeatability will be tested in both     healthy individuals and patients with chronic liver disease.      II. COPD - Chronic obstructive pulmonary disease is a leading cause of death worldwide, and     can potentially have an effect on the MBT since the breath test is based on CO2 production     and these subjects may have abnormal CO2 production.      III. Smoking- 13C Methacetin is metabolized by healthy hepatocytes reflecting hepatic     microsomal function of CYP1A2, and smoking may cause induction of CYP1A2. Furthermore,     internal preliminary data has shown signs that there is an influence of smoking on the MBT     ranges.      IV. Age- Empirical data on several hundred subjects with chronic liver disease has shown that     age is a significant factor in determining the probability of disease severity and     preliminary data in normal subjects have shown changes in MBT with age.. Therefore, the     effect of age has to be elucidated in an orderly fashion.      V. CYP450 1A2 Inhibitors- Several drugs and food items inhibit CYP450 1A2 and may affect the     MBT.      VI. Alcohol - Alcohol ingestion leads to induction of hepatic CYP and at a later stage to     inhibition due to liver damage. Acute alcohol ingestion may therefore effect MBT results.      VII. Beta-blockers - beta blocker are affecting portal hypertension and may affect hepatic     blood flow and thereby the outcome of the methacetin breath test.   "
158804|NCT01205061|"     The purpose of the study is to compare the effectiveness and safety of Emervel Deep Lidocaine     versus Juvederm® Ultra Plus in the treatment of moderate to severe facial wrinkles and folds.   "
158805|NCT01205048|"     The purpose of this study is to compare the effectiveness and safety of Emervel Classic     Lidocaine versus Juvederm® Ultra in the treatment of moderate to severe facial wrinkles and     folds.   "
158806|NCT01205035|"     Idiopathic Parafoveal Telangiectasia (IPT) [also known as Idiopathic Perifoveal     Telangiectasia, Idiopathic Juxtafoveal Telangiectasia (IJT, JFT) and Macular Telangiectasia     (MacTel)] is a disorder of unknown etiology. IPT is classified as Group 2A in the Gass     classification of macular telangiectasias (Reference 1,5) - a bilateral, but not always     symmetric disorder. It is characterized in its early stages by dilation and loss of     parafoveal capillaries accompanied by angiographic leakage, right angle venules, central     and parafoveal intraretinal cysts.   "
158807|NCT01205022|"     RATIONALE: Radiolabeled monoclonal antibodies can find tumor cells and either kill them or     carry tumor-killing substances to them without harming normal cells. Giving radioactive     substances together with antibodies may be effective treatment for some advanced cancers.     Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, and leucovorin     calcium (FOLFIRI), work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood     flow to the tumor. Giving radiolabeled monoclonal antibodies together with combination     chemotherapy and bevacizumab may be an effective treatment for colorectal cancer.      PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of     yttrium Y 90 DOTA anti-CEA (Carcinoembryonic antigen) monoclonal antibody M5A when given     together with combination chemotherapy and bevacizumab in treating patients with metastatic     colorectal cancer.   "
158808|NCT01205009|"     In an era of delayed fertility plans, there is increasing need for fertility treatment in     older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to     treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.   "
158809|NCT01204996|"     The purpose of this study is to evaluate the safety and dose regimen of CNTO 888 when     administered to patients with solid tumors in combination with 4 standard of care     chemotherapy regimens.   "
159020|NCT01202227|"     The purpose of this study is to assess the safety of the long-term use of pregabalin at doses     up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain,     post stroke pain, and multiple sclerosis pain).   "
158810|NCT01204983|"     Human milk is associated with substantial benefits to infants' health and development,     especially in premature infants. Some mothers are unable or unwilling to provide breast milk     to their infant. The use of donor human milk as an alternative to cow milk in these infants     has risen dramatically in the past year. However, there have been recent reports of     hyperphosphatemia and hyponatremia associated with the consumption of donor human milk     products. These electrolyte imbalances can lead to concerning symptoms, including headache,     nausea, vomiting, altered mental status, coma, seizures, or heart failure. It is important to     recognize and appropriately treat these electrolyte disturbances associated with donor human     milk to avoid potential nutritional problems.   "
172168|NCT00095810|"     The purpose of this clinical research study is to assess the safety and tolerability of     aripiprazole in patients with psychosis associated with Parkinson's disease.   "
158814|NCT01204931|"     Gastroesophageal reflux disease (GERD) is currently defined as a condition which develops     when the reflux of stomach contents causes troublesome symptoms and/or complications.     Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. In     recent years, the prevalence of partial or non-response to Proton Pump Inhibitors (PPI) has     increased resulting in diagnostic testing with esophagogastroduodenoscopy (EGD) or ambulatory     pH monitoring. Most patients do not have endoscopic evidence for reflux. Thus, in this group     pH monitoring has emerged as an important physiologic test to determine the degree of     esophageal acid exposure and to assess the association between patients' persistent symptoms     and acid reflux events. The aims of this study are to assess the sensitivity and specificity     of symptom associated indices and determine the best parameter for predicting GERD from a     list of conventional pH measurement findings.   "
158815|NCT01204918|"     This study aims to examine the antidepressant efficacy of riluzole, employing a randomized,     double-blind, placebo-controlled, adjunctive trial in treatment-resistant major depressive     disorder (TRD).   "
158816|NCT01204905|"     This is a pilot, open-label study of raltegravir and maraviroc in combination for the     treatment of antiretroviral naïve patients. The study will enroll 10 antiretroviral naïve     patients with CD4 counts ≥ 350 and viral loads > 5,000. The subjects will be followed for 48     weeks. The combination of these two agents has the potential to be a potent regimen with     minimal metabolic complications. However, they have not been studied in combination     previously.      This pilot study proposes to evaluate this combination in antiretroviral naïve patients to     document the safety and efficacy of this combination in order to provide clinicians with a     treatment regimen that minimizes the risk of metabolic complications.   "
158817|NCT01204892|"     The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis     Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of     trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.      Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce     postoperative pain scores when compared to conventional postoperative pain control with local     infiltration of trochar insertion sites.   "
158818|NCT01204879|"     This study will evaluate the efficacy of an exercise-based contingency management (CM)     intervention. A total of 120 substance abusing patients in intensive outpatient treatment     will be randomly assigned to one of two conditions: (a) standard care plus CM for completing     goal-related activities not related to exercising (e.g., improving work, family, or     transportation issues), or (b) standard care plus CM for completing exercise-related     activities. Compared to those receiving goal-related CM activity contracting, it is expected     that those in the exercise CM condition will participate in more physical activities and     develop greater strength and flexibility, decrease drug use, reduce HIV risk behaviors,     lessen depressive symptoms, and improve health indices.   "
158819|NCT01204866|"     The purpose of this study is to determine if Valortim, or one or more of its selected     formulation components, induces a wheal reaction when introduced percutaneously.      Two of 4 subjects dosed in a previous study with a modified formulation of Valortim     experienced treatment related adverse events which were suggestive of allergic or     allergic-like reactions. In order to better characterize these reactions and determine if     they represent allergic or allergic-like reactions to Valortim or one or more of its     components, skin testing of Valortim and selected components on naïve and Valortim-exposed     subjects will be performed in this study   "
158820|NCT01204853|"     The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were     demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU,     Canada and Australia. In this study, the safety and efficacy after administrations of     sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be     investigated in Japanese PAH patients.   "
158821|NCT01204840|"     The purpose of this study is to determine if growth hormone given 4 weeks before as well as     during a cycle of in vitro fertilization will improve outcomes in women who have had previous     failure with IVF treatment cycles using high doses of follicle stimulating medications and     had a poor response (less than 6 follicles).   "
158922|NCT01203514|"     This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in     infants of <1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early     erythropoietin (Epo) and iron therapy would decrease the number of transfusions received. For     infants 1,001-1,250g birth weight, we tested whether early erythropoietin (Epo) and iron     therapy would decrease the percentage of infants who received any transfusions.   "
158822|NCT01204827|"     Patients with HBeAg negative chronic HBV and evidence of hepatic disease (elevated liver     enzymes or evidence of cirrhosis) who have significant viremia are treated with anti HBV     therapy. Currently the key goals of anti HBV therapy are profound and prolonged viral     suppression and treatment efficacy is assessed by monitoring viral load and liver enzymes.     However these do not always reflect the degree of liver impairment or the degree of     improvement in response to therapy. Sebivo has been accepted in Israel as a first line     therapy for HBeAg negative and HBeAg positive chronic HBV with evidence of liver damage.     Viral load should decrease by 1 log every 3 months, otherwise patients should be offered     add-on or alternative therapy. As the majority of patients in Israel are HBeAg negative     chronic HBV and in order to have homogenous population we will select for our study only     patients with HBeAg negative chronic HBV. The 13C Methacetin breath test, assess liver     function and specifically the function of the microsomal CYP4501A2. It has been shown to     correlate with the degree of liver impairment and with clinical outcomes in both acute and     chronic liver disease. The aim of this study is to determine the utility of the 13C     Methacetin Breath Test to follow up patients with HBeAg negative chronic HBV receiving anti     viral therapy.   "
158823|NCT01204814|"     MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the     prevalence of ARV resistance in the population of women who present to study sites to be     pre-screened or screened for participation in an HIV prevention trial. To date, a     comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive     age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV     drug resistance mutations among women who test HIV-positive when presenting to screen for     participation in HIV prevention trials.   "
158825|NCT01204788|"     Patients with leukemia often have low white blood cell counts after chemotherapy, which puts     them at greater risk for infection. The standard of care for preventing infections is to give     these patients antibiotic, antifungal, and antiviral drugs during the time that white blood     cell counts are low. However, many patients still develop infections during chemotherapy.     Radiated white blood cell transfusions are a standard treatment once a patient develops a     severe infection.      The goal of this clinical research study is to learn if giving unirradiated white blood cell     transfusions early in chemotherapy might delay or prevent infections in patients with     leukemia. Researchers also want to learn more about the type and severity of any infections     that do occur.   "
158826|NCT01204775|"     The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin     in pediatric patients with type 2 diabetes.   "
158827|NCT01204762|"     At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious     for the treatment of chronic hepatitis B virus infection (CHB)      Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain preliminary     data on the safety of pegylated interferon Lambda (Lambda) when administered in combination     with Entecavir(ETV) to patients with hepatitis E antigen-positive (HBeAg-positive) chronic     hepatitis B(CHB) infection employing a sequential therapy approach   "
158828|NCT01204749|"     The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is     superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or     resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.      AMG 386 is a man-made medication that is designed to stop the development of blood vessels in     cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called     angiogenesis, to obtain a supply of oxygen and nutrients to grow.   "
158829|NCT01204736|"     Active elbow extension has significant functional benefits for individuals with tetraplegia.     The proposed work will provide information to assess how effectively people are using their     elbow extension tendon transfers, and whether one surgery works more effectively than the     other. This study will provide recommendations to clinicians about the possibility of     improving function after surgery using rehab techniques.   "
158830|NCT01204723|"     The primary objective of this application is to test the neurobehavioral mechanisms and     effects of aprepitant as a new cessation agent for cannabis, tobacco or both.   "
158831|NCT01204710|"     This is a study evaluating the safety and efficacy of the monoclonal antibody IMC-3G3 plus     mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic     castration-refractory prostate cancer following disease progression or intolerance on     docetaxel-based chemotherapy.   "
158832|NCT01204697|"     This randomized parallel group study will assess the efficacy and safety of erlotinib     [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in     former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer.     Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4     cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally,     days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is     until disease progression.   "
158841|NCT01204580|"     Primary Objective:      To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA)     in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M      Secondary Objectives:        1. To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in          type 2 diabetes patients after 8 weeks of therapy        2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks          of therapy with Amaryl-M        3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level          (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))        4. To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of          therapy with Amaryl-M        5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change          after 12 weeks of therapy with Amaryl-M        6. To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M        7. To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level   "
158833|NCT01204684|"     The main purpose of this study is to evaluate the most effective immunotherapy vaccine     components in patients with malignant glioma. Teh investigators previous phase I study (IRB     #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant     brain tumors, and with an indication of extended survival in several patients. However, the     previous trial design did not allow us to test which formulation of the vaccine was the most     effective. This phase II study will attempt to dissect out which components are most     effective together. Dendritic cells (DC) (cells which present or show cell identifiers to     the immune system) isolated from the subject's own blood will be treated with tumor-cell     lysate isolated from tumor tissue taken from the same subject during surgery. This pulsing     (combining) of antigen-presenting and tumor lysate will be done to try to stimulate the     immune system to recognize and destroy the patient's intracranial brain tumor. These pulsed     DCs will then be injected back into the patient intradermally as a vaccine. The investigators     will also utilize adjuvant imiquimod or poly ICLC (interstitial Cajal-like cell) in some     treatment cohorts. It is thought that the host immune system might be taught to recognize     the malignant brain tumor cells as foreign to the body by effectively presenting unique     tumor antigens to the host immune cells (T-cells) in vivo.   "
158834|NCT01204671|"     This study is designed to assess the safety and immunogenicity of a GSK Biologicals'     investigational vaccine GSK2321138A in adults 18 years old and older. This study is also     designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be     double blind for all groups except for the GSK2604409A Group which will be open.   "
158835|NCT01204658|"     This study will assess the safety, reactogenicity and immunogenicity of two formulations of     GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course     during the first 6 months of life followed by a booster dose at 12-15 months of age and     co-administered with DTPa-HBV-IPV/Hib vaccine.   "
158976|NCT01202799|"     It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac     administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject     convenience and compliance with a comparable bioavailability, safety and tolerability profile     to that of the approved PENNSAID solution administered four times a day (QID).   "
158836|NCT01204645|"     Chronic kidney disease (CKD) affects 10-18% of the adult population and is becoming     recognized as one of the most serious disorders causing increased risk for cardiovascular     disease and death. In patients with ischemic heart disease 26% have increased creatinine,     which rises to 40% if patients also have diabetes mellitus. Risk increases as renal function     diminishes, and just slowing the rate of decline in renal function would have a tremendous     impact on health and morbidity. This association is commonly termed the Cardiorenal Syndrome,     though it is caused by a much more complex interplay between major pathogenetic pathways such     as glucose metabolism and diabetes, systemic and tissue inflammation, tissue metabolism,     coagulation, mineral metabolism, sympathetic activation, renin-angiotensin-aldosterone system     activation, endothelial dysfunction, lipid metabolism, fetal programming etc.      Karolinska Institutet recently merged basic and clinical researchers in all these fields,     creating a Karolinska Kardiorenal Theme Centre; ultimately aiming to explore the syndrome and     provide improved care for the individual patient.      The investigators road to success:        -  Creating a Biobank (blood, DNA, plasma) from the majority of all hosptalized patients          with ACS in Stockholm county - Stockholmheartbank.        -  This Theme Center include all teaching hospitals associated with Karolinska Institutet;          Danderyd University Hospital, Karolinska University Hospital and Södersjukhuset          University Hospital. Together theses hospitals serve as emergency hospitals for 1.9          million people. The investigators are aiming at creating a biobank from all patients          admitted for an acute coronary event (about 2.300/yr), which is a unique asset for          molecular and genetic research as well as observational and intervention studies.        -  The investigators have access to the National registry with 100% coverage, that contains          data on all patients admitted to Stockholms coronary care units since 1995.        -  To ensure translation in to clinical practice, most of the researchers are also MD:s,          and several are clinically active.        -  The clinical network facilitates the development of novel therapies and translational          research.        -  Steering groups for Education and a Clinical Practice implementation program.   "
158837|NCT01204632|"     The purpose of this study is to develop and field-test new tools for diagnosis and hazard     assessment of cardiometabolic risk (CMR) in people with chronic spinal cord injury (SCI) and     to advance the evidence base with much needed information on CMR and cardiovascular disease     (CVD) burden in people with SCI. These data can be used to develop screening guidelines for     early identification and prevention of CMR in SCI, as well as targeted approaches to primary     disease management.   "
158838|NCT01204619|"     Since the emergence of home peritoneal dialysis as an alternative to in-center hemodialysis     for chronic renal replacement therapy in the late 1970s, the percentage of dialysis patients     on PD has continued to decrease each year. There have been a growing concern and research on     patient and technique survival of peritoneal dialysis versus hemodialysis to find influential     factors for better clinical outcomes. Meanwhile, technique failure rates were significantly     higher in small centers treating less than twenty five PD patients. And there was a result     for better technique survival after the second year, among the patients trained at the     BREC(Baxter Renal Education Center). Better technique survival in large centers can be     assumed with not only their more experience with patient management but also their     educational infrastructure compared to small-sized centers.      Throughout our experiences in the last 30 years, we have recognized that a major element of     PD program is patient training, however few data are available in terms of the relationship     between PD training and treatment outcome and mostly are retrospective and non-randomized.     Moreover, the technique survival and patient survival were analyzed with no significant     difference.      From the insight, we decided to study prospectively to evaluate the efficacy of     well-structured education program in terms of various patient outcomes in incident patients     on PD.   "
158839|NCT01204606|"     -  The purpose of this study is to compare the efficacy of periarticular injections          consisting of ropivacaine, morphine, epinephrine, cefotetan, and hyaluronic acid with          the efficacy of periarticular injections consisting of the same amount of          placebo(isotonic saline) during arthroscopic rotator cuff repair.        -  Adding of multimodal analgesia(MMA) to conventional rotator cuff repair, it was expected          that could reduce postoperative pain and narcotic consumption.   "
158840|NCT01204593|"     Primary Objective:      To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day,     tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type     1 Diabetes Mellitus (T1DM).      Secondary Objectives:      To evaluate:        -  The change of hemoglobin A1c (HbA1c) from baseline to week 12        -  The percentage of patients with HbA1c < 7% at week 12 and week 24        -  The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and          week 24        -  The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week          24        -  The incidence of symptomatic hypoglycemias        -  Adverse events   "
158923|NCT01203501|"     This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in     extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal     Research Network Generic Database whose mothers were given prenatal MgSO4, data were     prospectively collected on maternal/infant conditions and magnesium exposure (including     indications, timing and duration of exposure).   "
158842|NCT01204567|"     The aim of this study is to evaluate the effect of aerobic fitness training on mental health     (health-related quality of life),cognitive and physical capacity in older people discharge     from hospital and to assess if further aerobic training at home enhances the effect.      Design: Randomized controlled trial conducted at Oslo University Hospital, department of     Medicine in conjunction with Oslo University College. The subjects will be randomized into     one intervention group (training group) or one control group.      Outcome measure:      Health-related quality of life Physical function Cognitive capacity Physical activity Body     composition Physical activity level   "
158843|NCT01204554|"     The aim of the present study is to assess the microcirculatory changes in the distal part of     the perforator flap using ICG fluorescence angiography.   "
158844|NCT01204541|"     This study seeks to evaluate a novel endpoint for future dry AMD clinical trials.   "
158845|NCT01204528|"     To investigate whether treatment with a vitamin-D receptor activator is able to improve     important markers of cardiovascular risk.   "
158846|NCT01204515|"     Children and adults commonly suffer from recurrent abdominal (stomach) pain. One type is     called irritable bowel syndrome (IBS). IBS in adults and children is one of the most common     and costly health care problems in the US. Some children have pain frequently (recurrent     pain) while others rarely have pain. The investigators are conducting this study to help us     answer questions about the causes and treatments, and management of IBS in children.      The purpose of this study is to find out if there is more than one type of IBS in children.     If there is, this will be important in deciding the best treatments. The investigators also     want to learn how children with IBS differ from those who do not have recurrent abdominal     (stomach) pain.   "
158847|NCT01204502|"     Bone marrow or blood stem cell transplantation is used to treat a wide range of     life-threatening conditions. T lymphocytes carried in the graft have powerful beneficial     effects and play a vital role in the eradication of leukaemia and in fighting infection, but     can also damage healthy tissues and cause graft-versus-host disease (GVHD).      To safeguard against GVHD, the investigators propose modifying T cells to encode a 'switch'     so that they can be eliminated if problems arise.      Children receiving half-matched (haploidentical) transplants from a parent are most likely to     benefit from this strategy. At present these patients receive blood stem cells from a parent,     but the T cells are removed because the risk of serious GVHD is unacceptable. This means that     they are much more likely to suffer from life threatening infections or experience a relapse     of leukaemia. The investigators want to use gene therapy to produce safe T cells which can     be used to strengthen the transplant and prevent these serious complications.   "
158848|NCT01204489|"     Study aims to pilot a family-centred tailored nutrition intervention at child welfare     clinics, targeting the previously observed dietary defaults of Finnish children.   "
158849|NCT01204476|"     This phase I trial studies the side effects and best dose of cixutumumab when given together     with everolimus and octreotide acetate in treating patients with advanced low- or     intermediate-grade neuroendocrine cancer. Monoclonal antibodies, such as cixutumumab, may     find tumor cells and help carry tumor-killing substances to them. Everolimus may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide     acetate may interfere with the growth of tumor cells and slow the growth of neuroendocrine     cancer. Giving cixutumumab together with everolimus and octreotide acetate may be a better     treatment for neuroendocrine cancer.   "
158850|NCT01204450|"     RATIONALE: Drugs such as temsirolimus and valproic acid may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Valproic acid may also stop the growth     of solid tumors by blocking blood flow to the tumor.      PURPOSE: This phase I trial is studying the side effects and the best dose of temsirolimus     when given together with valproic acid in treating young patients with relapsed     neuroblastoma, bone sarcoma, or soft tissue sarcoma.   "
158851|NCT01204437|"     Although approximately 50% of new diagnosis breast cancers are in patients above the age of     65, elderly people remain substantially under-represented in clinical trials, and therefore     are under-treated. A recent trial of the CALBG in patient's ≥ 65 years with medium risk of     breast cancer demonstrated an improved disease-free and overall survival for those treated     with AC or CMF compared to those treated with capecitabine alone.      The primary aim of the ICE II trial is to determine the compliance and toxicity of epirubicin     plus cyclophosphamide (EC) or CMF versus nab-paclitaxel plus capecitabine as adjuvant therapy     in non frail elderly patients.   "
158852|NCT01204424|"     The success of dental implants is based on a variety of factors including; surgical     technique, health of the patient, operator skill and, to a significant part, sufficient bone     for the placement and integration of dental implants. To that end, the replacement of the     maxillary posterior teeth have presented a considerable challenge because, after the loss of     maxillary posterior teeth the quality and quantity of the remaining supporting bone may be     insufficient to support implants properly or reliably. To overcome the deficiency of     insufficient vertical bone mass of the maxilla, several surgical techniques have been     developed to increase available bone mass for the replacement of dental implants by bone     augmentation.      The conventional procedure for a sinus lift (Caldwell-Luc procedure) requires preparation of     a mucoperiosteal flap in the buccal molar region and to cut an oval window in the thus     exposed bone, without damage to the subjacent maxillary sinus membrane. The procedure is very     invasive and subjects the patient to great stress as a result of substantial swelling and     discoloration of up to 10 days, and possibly of pain. This surgical procedure is oftentimes     referred to as open or classic sinus lift. This technique is fraught with many risks and     complications because of the limitations of healing potential in the maxillary sinus. In     spite of these risks many patients undergo this procedure because of the strong desire to     replace missing maxillary teeth with dental implants.      An alternative approach to the maxillary sinus from the inferior approach of the alveolar     ridge utilizing solid cylindrical osteotomes was described by Dr. Summers (crestal sinus     lift). It is a more conservative approach and is less invasive. It was developed to eliminate     the risks described above.While this technique is safer, an overzealous use of an osteotome     during the placement of the regenerative material can result in the perforation of the     subantral membrane with disadvantages discussed above.      Dr. Eder has developed an innovative way - the JEDER System - of carrying out a crestal sinus     lift that substantially reduces the risk of perforating the subantral membrane. This minimal-     invasive way uses 2 newly developed and successfully patented instruments, the     Druckkammerknochenfräse DKK and the Sinusvibrationspumpe SVP. Following JEDER Syst. the     mucous membrane of the mouth is opened from the toothless part of the maxillary crest up to     the bone and the bone is scraped by a cylindrical cutter in the shape of a tunnel up to     slightly underneath the maxillary sinus membrane.      The aim of the study is to assess the efficacy and safety of the JEDER Syst., which was     already demonstrated in 50 treatment attempts. The results of this study will be used for the     certification process to enable the declaration of conformity for the market approval.      The main outcome parameter is the perforation rate of the subantral membrane intraoperatively     and within 6 weeks after the operation.      Risk benefit assessment:      In the present study there will be no additional examinations undertaken compared to patients     which undergo the conventional procedure. The conventional procedure is associated with a     risk of membrane perforation and consecutive diseases like infection, swelling and pain. All     these inconveniences should be avoided by using the JEDER Syst. If the worst case scenario -     the perforation of the subantral membrane - happens, the conventional method will be used.     Therefore, the risk-benefit assessment   "
158853|NCT01204411|"     The purpose of the study is to determine whether the artesunate-amodiaquine combination is     effective in treating uncomplicated Plasmodium falciparum malaria in children with severe     acute malnutrition.      Infection with Plasmodium falciparum malaria remains a significant cause of morbidity and     mortality in malnourished children. Malnutrition is known to have a modulating effect on the     incidence of malaria infections, its severity and effectiveness of treatments. However,     little data exists on antimalarial drug efficacy in malnourished children.     Artesunate-amodiaquine combination is the first line treatment used in Médecins Sans     Frontières programmes in Niger. The assumption of current efficacy of artesunate-amodiaquine     is based on non malnourished children. The aim of this study is to measure the clinical and     parasitological efficacy in severely malnourished children.      The study is consistent with the standard WHO protocol for monitoring antimalarial drug     efficacy (WHO: Methods for surveillance of antimalarial drug efficacy. Geneva; 2009), except     for one inclusion criterion. Severe acute malnutrition is an inclusion criteria, instead of     being an exclusion criteria. The study will encompass a pharmacokinetic part that will     provide important information on the absorption of the drug.   "
158854|NCT01204398|"     The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in     the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic     blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan     80mg/Amlodipine 5mg in patients with moderate to severe hypertension   "
158855|NCT01204385|"     The purpose of the study is to identify the bacterial aetiology of acute otitis media     episodes in young children aged ≥ 3 months to < 5 years in Saudi Arabia.   "
159021|NCT01202214|"     The purpose of this study is to describe the safety and tolerability of single and repeat     oral doses of GSK1440115 in healthy volunteers.   "
158856|NCT01204372|"     GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and     tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line     chemotherapy in metastatic pancreatic cancer patients.      The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30     min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks     followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for     three weeks followed by one week of rest.      Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and then     at 2 mg/kg over 30 min. for the subsequent infusions.      Erlotinib will be administered orally at a dose of 100 mg/day from C1D1.      The patients will be subjected to research for the EGFR, HER2 and KRAS status.   "
158895|NCT01203865|"     The prevalence of fibromyalgia syndrome in the Israeli population is of importance fro     planning resource allocation of medical expenditure as well as for identifying demographic     and ethnic differences of this unique population compared with other western samples. In the     current study the investigators aim at estimating the prevalence of fibromyalgia in this     population. For this purpose a two - stage process will be used. First, a population survey     will be conducted by telephone, screening for widespread pain and fatigue in the general     population. This survey will use the London Fibromyalgia Epidemiology Study Screening     Questionnaire. Second, a sample of patients attending the rheumatology clinic will be     surveyed with this tool and will be examined in order to determine the actual proportion of     patients fulfilling ACR criteria for fibromyalgia. This will enable us to calculate the     positive predictive value of the London Fibromyalgia Epidemiology Study Screening     Questionnaire in our population and hence to calculate the prevalence of fibromyalgia in the     population.   "
158857|NCT01204359|"     Iodine 131 (131I） treatment on Graves disease and Graves ophthalmopathy relationship has     always been the focus of debate. Majority view is that the current treatment does not     increase 131I Graves ophthalmopathy, therefore,Graves disease associated with exophthalmos is     not a contraindication of 131I treatment. While treatment with corticosteroids, a timely     corrective measures to be effective in preventing Graves ophthalmopathy adverse effects. But     the merger with severe proptosis in patients with Graves , especially infiltrative     exophthalmos , the application of 131I treatment will induce or aggravate not yet reached     consensus, so, the 131I treatment is still very careful , mainly due to plaque prospective     study and visual assessment is not lack of uniform standards, and a variety of factors     (including smoking, work status, and 131I treatment of thyroid doses, etc.) may also     interfere or influence the ultimate effect of 131I on the Graves ophthalmopathy. In the view     of this situation Graves disease patients with Graves ophthalmopathy could be 131I treatment     or not, how to dose adjustments, and the use of which required treatment with systemic issues     such as research, explore treatment exophthalmos reduction and mitigation of increased     proptosis reasonable treatment of symptoms. To further promote the standardization of 131I     treatment of Graves disease on basis.   "
158858|NCT01204346|"     Mentalisation based treatment (MBT) for young people with co-morbid depression and emerging     personality disorder will be more effective in a day/inpatient setting than treatment as     usual.   "
158859|NCT01204333|"     Background: Endovascular thrombolysis, with or without mechanical clot removal (ET), may be     beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have a     poor prognosis despite treatment with heparin. Published experience with ET is promising, but     only based on case series and not on controlled trials.      Objective: The main objective of the TO-ACT trial is to determine if ET improves the     functional outcome of patients with a severe form of CVT      Study design: The TO-ACT trial will be designed as a multi-centre, prospective, randomized,     open-label, blinded endpoint (PROBE) trial.      Study population: Patients are eligible if they have a radiologically proven CVT, a high     probability of poor outcome (defined by presence of one or more of the following risk     factors: mental status disorder, coma, intracranial hemorrhagic lesion or thrombosis of the     deep cerebral venous system) and the responsible physician is uncertain if ET or standard     anti-coagulant treatment is better.      Intervention: Patients will be randomized to receive either ET or standard therapy     (therapeutic doses of heparin). ET consists of local application of alteplase or urokinase     within the thrombosed sinuses, and/or mechanical thrombectomy. Glasgow coma score, NIH stroke     scale and relevant laboratory parameters will be assessed at baseline.      Endpoints: The primary endpoint is the modified Rankin scale (mRS) at 12 months. The most     important secondary outcomes are the mRS, mortality and recanalization rate at 6 months.     Major intra- and extracranial hemorrhagic complications within one week following the     intervention are the principal safety outcome. Results will be analyzed according to the     intention-to-treat principle. Assessment of study endpoints will be carried out according     to standardized questionnaires by a blinded neurologist or research nurse who is not involved     in the treatment of the patient.      Study size: To detect a 50% relative reduction in mRS≥2 (from 40 to 20%), 164 patients (82 in     each treatment arm) have to be included (two-sided alpha, 80% power).      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Included patients may benefit directly from ET. Complications of ET, most     notably intracranial hemorrhages, constitute the most important risk of the study.   "
158860|NCT01204320|"     This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or     paclitaxel-eluting stent implantation in patients with stable or unstable angina with the     evaluation of restenosis by Quantitative Coronary Analysis.   "
158861|NCT01204307|"     To compare the differential influence of 1st line doublet chemotherapy containing Docetaxel     versus Pemetrexed on clinical efficacy of Erlotinib as a second line therapy in patients with     relapsed or progressed non-squamous NSCLC.   "
158862|NCT01204294|"     The objective of the current study is to investigate the safety and efficacy of linagliptin     (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes     mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one     approved antidiabetic drug.   "
158863|NCT01204281|"     To evaluate the effectiveness of high assistance proportional assist ventilation (PAV+)     (objective 80% gain) as main ventilatory support in early stage of critically ill patients in     comparison with standard volume-assist control ventilation (ACV).   "
158864|NCT01204268|"     The current study is designed to clarify the neuroprotective effect of sevoflurane     preconditioning on the patients underwent intracranial aneurysm surgery.   "
158865|NCT01204255|"     RATIONALE: Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into     the skin, may be an effective treatment for nausea and vomiting.PURPOSE: This clinical trial     studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in healthy volunteers.   "
158866|NCT01204242|"     The purpose of this study is to determine whether a local anesthetic drug (lidocaine) given     during anesthesia intravenously (IV) through a needle in your vein,), can:        1. Help decrease pain after surgery.        2. Have you need less pain medication.        3. Have less side effects like nausea and vomiting following your surgery.        4. Help to prevent chronic pain.        5. Affect recurrence of cancer after surgery.   "
158867|NCT01204229|"     In the proposed project the investigators will develop and test a novel brief intervention     targeting college students who drink heavily to cope with anxiety and depression, a behavior     that increases risk for the development of alcohol dependence.   "
158919|NCT01203553|"     Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such meshes     are mainly implanted via open or laparoscopic approach. The differential impact of these two     types of surgical technique on recurrence rate will be investigated with this study.      With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia     repair will be investigated prospectively. Hernia recurrence is the main outcome measure.   "
159022|NCT01202201|"     The purpose of this study is to evaluate the epidemiology and baseline disease burden of     rotavirus gastroenteritis in children < 6 years of age, in Japan.   "
158896|NCT01203852|"     There are many medications available for the treatment of high blood pressure (hypertension),     but finding the right one for a specific patient can be challenging. In fact, it is estimated     that less than 50% of people with hypertension have their blood pressure under control. The     hypothesis is that genetic differences between individuals influence their response to     antihypertensive medications. This study is aimed at determining the genetic factors that may     influence a person's response to either a beta-blocker or a thiazide diuretic. The hope is     that through this research, the investigators may someday be able to use an individual's     genetic information to guide the selection of their blood pressure medicine, leading to     better control of blood pressure, and less need for the current trial and error process.   "
158868|NCT01204216|"     Prevention of complications in veterans with diabetes depends heavily on assessment of blood     glucose and HbA1c. The HbA1c is a blood test that measures the exposure of hemoglobin (Hb) to     a person's average blood glucose over the lifespan of a red blood cell (RBC). The test is     heavily relied upon as a measure of blood glucose control. It is normally assumed that all     people (those with and without diabetes) have a narrow range of red blood cell survival. It     has been recently shown that this is not a valid assumption.      A more precise test of red blood cell survival, using a biotin label method, demonstrated a     substantial difference of red blood cell survival among otherwise normal people. There is     sufficient difference in red blood cell survival to alter the estimate of glycemic control     from the HbA1c test by as much as 30 per cent. This introduces concern that HbA1c values do     not mean the same thing in a significant number of people.      Although the evidence is clear that there is variation in RBC survival among people,     attributing this variation to differences between individuals depends on answering several     simple questions which surprisingly remain unanswered: whether RBC survival is stable over     time within an individual and whether blood glucose control affects its stability. Therefore,     the goal of the proposed studies is to define these characteristics.   "
158869|NCT01204203|"     The primary objective of this trial is to determine the response rate of single agent     zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria     and the EORTC tumor response criteria for 18F-FDG PET scans.   "
158870|NCT01204190|"     The primary objective of this trial is to examine whether ovulation is suppressed after use     of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD)     for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones     produced by your body) will be measured and transvaginal ultrasound examinations will be     conducted at regular intervals. In addition, the concentrations of the administered hormones     EE and GSD in blood will be determined in regular intervals.      With regard to the tolerability of the hormone patches subjects will be asked regularly how     they feel and blood pressure, pulse and body weight will be determined. In addition, blood     and urine safety examinations will be conducted at defined timepoints.   "
158871|NCT01204177|"     This study investigates the safety and efficacy of the combination therapy with BAY86-9766     and sorafenib in patients with liver cancer. Safety will be determined by laboratory and     other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by     disease control rate, overall survival, time to progression, response rate and duration of     response.   "
158872|NCT01204164|"     This is a multicenter, open-label, dose escalation Phase 1 study.   "
158873|NCT01204151|"     Children with FXS are predisposed to manifesting a particular profile of intellectual     strengths and weaknesses, including specific deficits in math, visual-spatial skills,     executive functioning, and social skills. Until now, intensive behavioral interventions have     not been targeted to syndrome-specific weaknesses. In the present study we will develop and     evaluate behavioral strategies to aid skill acquisition in children with FXS.   "
158874|NCT01204138|"     A Phase II, single institution, double blind, randomized, placebo controlled, cross-over     study exploring the safety and efficacy apremilast in patients with active RA with     concomitant use of TNF inhibition. Following a screening period, patients with active disease     on stable TNF inhibition will be randomized to receive either apremilast or placebo for a     period of 12 weeks. At the end of 12 weeks patients will be assessed for efficacy using the     ACR responder index looking for a 20% improvement, then all patients initially randomized and     treated in a blinded fashion with apremilast will be crossed over to placebo while those     patients initially randomized and treated with placebo will be crossed over to apremilast.     Patients will be followed for an additional 12 weeks on treatment to assess both safety and     efficacy of this combination treatment. Following 24 weeks of active treatment or early     termination, patients will undergo a 28 day safety visit.   "
158875|NCT01204125|"     Primary Objective:      - to assess the pathological Complete Response (pCR) rate in the breast of patients treated     in following combinations: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly+     weekly paclitaxel, and weekly paclitaxel single agent as calibrator.      Secondary objectives are:        -  pCR rate in the breast and axilla,        -  Radiological/clinical objective response rate (ORR), breast conservation rate, disease          free survival (DFS), and overall survival (OS), in each treatment arm,        -  Safety profiles of study combinations and of the single agent reference treatment,        -  Molecular characteristics of the tumor tissue and peripheral blood mononuclear cells          (PBMC) and any correlation between the biological activity of the study treatment and          the disease outcome.      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
158876|NCT01204112|"     The current study is designed to estimate the effect of rifampin (600 mg orally every 24     hours for 7 days) on pharmacokinetics of single 30 mg dose (CP-690,550) in normal healthy     volunteers   "
158877|NCT01204099|"     Phase 1: To determine the maximally tolerated dose (MTD) or recommended dose (RD) and any     potential efficacy of PX-866 in combination with docetaxel in patients with solid tumors.      Phase 2: To determine the antitumor activity and safety of PX-866 in combination with     docetaxel versus docetaxel alone in patients with NSCLC or SCCHN.   "
158878|NCT01204086|"     The purpose of this study is to establish the clinical effectiveness of antidepressants by     pharmacogenomic approach, and to determine the levels of inflammatory factors between the     baseline and the end point of the study in Taiwanese major depressive disorder (MDD)     patients.   "
158879|NCT01204073|"     This is the first study in which TAK-441 is administered to humans. The patient population     will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for     whom standard treatment is no longer effective or does not offer curative or life-prolonging     potential. Following completion of the dose escalation study, patients will be enrolled as     part of 2 expansion cohorts.   "
158880|NCT01204060|"     Asthma is one of the most common diseases affecting about 2.5 million Canadians, and can     result in reduced quality of life and difficulties with work and school. Once the disease has     become established with irreversible changes in the lungs it can be very difficult to treat.     Severe asthma although less common than mild asthma uses more healthcare resources.      The objective of this project is to find out how the changes in the lung develop in severe     asthma. Once this is known then new treatments can be developed to prevent irreversible     damage to the lungs.      Volunteers will have substances sprayed up their nose and then samples collected from their     nose. Levels of proteins and cells can be measured in these samples. This will give an     indication of the type of inflammation that occurs.      The usual method of investigating the changes that occur in asthma is to challenge the lungs.     Samples have to then be collected from the lungs. This can be in the form of sputum which     must be treated to break it down to a liquid or washed out during a camera test. These     methods cause problems with measuring proteins and they are broken down or diluted. Because     the nose is easily accessible samples can be obtained at many time points. Because the     samples can be collected directly from the nose the problems with obtaining samples from the     lung are avoided.   "
158881|NCT01204047|"     The specific aims of this study are: 1) to assess the test-retest reliability of a     modification of an existing wheelchair propulsion assessment and 2) validate the modification     against traditional measures of physical strength, power, and endurance in a group of persons     with spinal cord injury (SCI).   "
158882|NCT01204034|"     The objective of this study is to evaluate the effect of the combination of formoterol and     beclometasone dipropionate on central and peripheral airway dimensions in COPD patients using     Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on     lung function (spirometry, body plethysmography), the BODE index, COPD assessment test (CAT)     and Borg CR10 scale will be assessed and the safety will be evaluated.   "
158883|NCT01204021|"     There has been a dramatic rise from 46% to 59% in the percentage of households with only 1-2     people from 1970 to 2000. A 40% increase in the number of people living alone is projected     for 2010. Social isolation is consistently one of the strongest predictors mortality in older     adults. Recent research is demonstrating that stress plays an important role linking social     isolation with poor health. Socially isolated older adults are more likely to feel     chronically stressed and overwhelmed with everyday life demands. Furthermore, isolated adults     respond to stress differently, both psychologically and physiologically. Socially isolated     and lonely older adults show long-term elevations in inflammatory cytokines, which are     signaling molecules related by immune cells. These Inflammatory cytokines play a role in a     number of age-related diseases including cardiovascular disease, type-2 diabetes and     arthritis. Novel, readily useable interventions aimed at decreasing isolation and     re-calibrating stress responses might be helpful to older adults.      Tai Chi is an ancient Chinese form of calisthenics that promotes relaxation and decreases     feelings of stress and as such, it may be a useful intervention for socially isolated,     stressed older adults. However, its effects on stress responses are unknown. Tai Chi Chih     (TCC) is a simplified, manualized, readily exportable form of Tai Chi particularly     well-suited for older adults. This proposed study will test the effects of a TCC intervention     with socially isolated older adults on loneliness, stress and health outcomes, including     inflammatory assessment. Tai Chi-naïve participants who perceive themselves as socially     isolated, as measured by the UCLA Loneliness Scale will be randomized to receive either Tai     Chi or education control for a 12-week period. Subjects will undergo pre- and     post-intervention stress assessment, including exposure to a psychological stress task, to     assess whether Tai Chi affects how subjects physiologically and psychologically respond to     stress.   "
158884|NCT01204008|"     Summary: This is a prospective randomize study to compare conservative and aggressive     discectomy for treatment of disc herniation with radiculopathy.      Study hypothesis: The investigators believe that conservative discectomy could preserve a     higher disc space and has a better long-term outcomes.   "
158885|NCT01203995|"     The purpose of this study is to provide testing methods of delivering nutrition and physical     activity services for weight loss.   "
158886|NCT01203982|"     The aim of this study was to measure the effect of moderate and intensive lipid-lowering     treatment with rosuvastatin on the carotid intima-media thickness (CIMT) as a surrogate     marker of cardiovascular risk.   "
158887|NCT01203969|"     This randomized trial is designed to identify the safety and efficacy of single port     laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.   "
158888|NCT01203956|"     There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when     using the DeVilbiss AutoAdjust device.   "
158889|NCT01203943|"     The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in     idiopathic pulmonary fibrosis patients.   "
158890|NCT01203930|"     This study is to evaluate the safety and clinical activity of idelalisib alone and in     combination with rituximab in patients with CLL or SLL.      This Phase 2 study will be the first time that idelalisib is administered to previously     untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical     activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity,     which supports its evaluation in previously untreated patients. The study population is     limited to patients over 65 years of age because younger patients are generally appropriate     for standard immunochemotherapy regimens that are highly active. Since the mechanism of     action of idelalisib is distinct from rituximab, it is hypothesized that the combination will     be more active than either agent alone. This study will establish initial safety and clinical     activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of     this study will establish safety and clinical activity of idelalisib alone in subjects with     untreated CLL or SLL.   "
158891|NCT01203917|"     This study is carried out to see how Caucasian patients with lung cancer which has EGFR     mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also     be collected and analysed to confirm that treatment with gefitinib is safe and well     tolerated.   "
158892|NCT01203904|"     The purpose of this study is to confirm the safety profile for long term treatment in     children aged 5 years and <15 years on bronchial asthma in daily clinical usage/Effect on     growth rate. Effect on adrenal function. Development of infection diseases by diseases type.   "
158893|NCT01203891|"     The objective of the study is to acquire a database of Single Photon Emission Computed     Tomographic (SPECT) studies of the brains of normal human subjects in resting and     concentrating states. The database will provide a basis for subsequent investigation of     meaningful brain differences between clinical and normal subject groups   "
158894|NCT01203878|"     The purpose of this study is to explore the effect of treating actinic keratoses of the face     with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with     imiquimod alone   "
158897|NCT01203839|"     Currently the standard of care is to treat early stage invasive breast cancer or ductal     carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as     breast-conserving therapy (BCT). The traditional method of giving radiation therapy after a     lumpectomy is to the whole breast.      However the investigators do not know if the whole breast needs to be receive radiation to     better control your cancer or only a more limited area of the breast surrounding the tumor.     The purpose of this study is to see the side effects of delivering partial breast irradiation     (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the     area of the breast where the cancer was removed. Another purpose of this study is to look     long term at the rate at which cancer comes back in the same breast after PBI.      WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial     breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The     investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a     day, five days a week, for 2 weeks.      In this study the investigators will learn about the good and bad effects of PBI radiation     therapy. In this study, the investigators will also learn about how the breast looks after     surgery and radiation therapy.   "
158898|NCT01203826|"     This clinical trial studies the long term safety and efficacy of asfotase alfa in children     with HPP who completed Study ENB-006-09.   "
158899|NCT01203813|"     Aim 1: To assess whether quality of care for stage 3 chronic kidney disease can be     substantially improved over 18 months by:        -  Point of care electronic alerts to primary care physicians recommending risk-appropriate          care, and        -  Quarterly mailings to patients providing self management support materials, including          tailored recommendations based on personalized data from an electronic disease registry      Aim 2: To assess the relationship between utilization of the intervention components and     primary care physician attitudes towards both chronic kidney disease management and     electronic reminder systems.   "
158900|NCT01203800|"     In this study the investigators intend to explore the long term significance of BBB     disruption on the clinical course and the rate of significant recurrent ischemic events in     patients with a chronic stroke.   "
158901|NCT01203787|"     Open-label study to evaluate the safety and tolerability of Sorafenib dose ramp-up (starting     at a lower dose and then gradually increasing the dose) versus standard Sorafenib dosing in     subjects with unresectable and/or metastatic hepatocellular carcinoma.   "
158902|NCT01203774|"     In this study the investigators would like to test the hypothesis that in diabetic patients     discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected     Glargine in terms of diabetes control, compliance, and patient satisfaction and preference.     The investigators will test this hypothesis in a randomized, crossover trial.   "
158903|NCT01203761|"     The experience of illness and hospitalization exerts a great deal of psychological distress,     one of the most distressful events people might experience throughout their life times.     Surgery and anesthesia with their accompanying loss of control, fear of being unconscious and     invaded, and expectation of postoperative pain adds appreciably to that stress and anxiety.      Current psycho-physiological research has provided evidence on the alarming possibility of     the aversive affects of hospitalization stress on the patients' already deteriorated physical     health and marked interference with their recovery.      As an additional stressor, which may partly be related to the hospital staff, and partly to     the person's illness and expected surgery is loneliness.      Loneliness is a painful experience that is, commonly, not embraced and which has consequences     that are detrimental to one's emotional, physical and spiritual well being.      The present study explores the qualitative aspects of loneliness (via questionnaires) in two     patient populations: (1) patients facing surgery, and (2) patients who have already undergone     surgery. In addition, family members [i.e. those waiting outside of the operating room] will     be given a questionnaire, and these three groups will be compared to the general population.   "
158904|NCT01203748|"     This investigation is designed with the hypothesis that combined PV Antral Isolation and     Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success     rate compared to the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and     to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.   "
158920|NCT01203540|"     Multicentre, Double blind, Randomized, Comparative Study(comparing N-acetyl-aspartyl-glutamic     acid(NAAGA) in Abak preservative free device versus SALINE in Abak preservative free device.      Evaluation of the effects and safety of NAABAK® through inflammation markers and symptoms in     patients with allergic conjunctivitis and dry eye syndrome after 3 months treatment.      The patients will attend 4 visits.   "
158905|NCT01203735|"     This is non-randomized phase 2 study to evaluate toxicity and efficacy of VA with concurrent     chemoradiotherapy (CCRT) containing weekly vinorelbine and cisplatin in patients with locally     advanced inoperable non-small-cell lung cancer (NSCLC).All patients will be planned for     three-dimensional conformal RT (3-DCRT). Concurrent weekly vinorelbine and cisplatin and oral     valproic acid (VA)will be started at the first day of RT. Follow up will be conducted every 3     months after completion of the study treatment. Toxicity will be assessed using CTCAE, based     on clinical examination and laboratory tests during the study treatment and at follow up     visits. Response to treatment will be evaluated using RECIST criteria. Overall and     progression free survival (OS and PFS) will be estimated using the Kaplan-Meier method.   "
158906|NCT01203722|"     If transplantation using mismatched unrelated donors or non-first-degree relatives could be     performed with an acceptable toxicity profile, an important unmet need would be served.     Towards this goal, the current study extends our platform of nonmyeloablative, partially     HLA-mismatched BMT to the use of such donors, investigating up to several postgrafting     immunosuppression regimens that incorporate high-dose Cy. Of central interest is the     incorporation of sirolimus into this postgrafting immunosuppression regimen. The primary goal     is to identify a transplant regimen associated with acceptable rates of severe acute GVHD and     NRM by Day 100.   "
158907|NCT01203709|"     A trial of combination of two drugs for the treatment of refractory lupus nephritis.   "
158942|NCT01203254|"     The purpose of this study is to assess the efficacy of cholestagel to reduce the frequency of     soft and liquid stools per day in patients with CD in clinical remission with symptoms of BAM     and to assess the improvement in stool consistency and quality of life in these patients and     to assess the safety of cholestagel.   "
158908|NCT01203696|"     Clopidogrel can reduce risk of cardiovascular disease by inhibiting platelet aggregation. It     is metabolized to an active drug by a liver enzyme. Its efficacy may be measured by blood     sampling for platelet activity, analyzed by VerifyNow device. Calcium Channel blocker (CCB)     is also commonly used for blood pressure and anginal control in these patients.     Dihydropyridine group of calcium channel blocker (e.g. amlodipine) inhibits this enzyme.     There are observational studies reporting dihydropyridine CCB reducing clopidogrel effect,     but the clinical implication is unclear.      This study test the hypothesis that there is no significant effect of dihydropyridines CCB on     clopidogrel response compared with control. After giving consent, patients with suboptimal     blood pressure or anginal control will be randomized to receive either dihydropyridine CCB or     non-CCB as placebo. These patient will be follow-up in 1 month.   "
158909|NCT01203683|"     The purpose of this study is to determine whether completing a computer-based program alters     changes how the brain processes emotional information and improves symptoms of depression.   "
158910|NCT01203670|"     The aim of the study is to evaluate renal and digestive tolerance of a food supplement,     phytalgic, on elderly volunteers.   "
158911|NCT01203657|"     Although a number of studies have examined the effects of Tai Chi in older adult populations,     few have methodically assessed its effects on vitality, fatigue and physical activity. Some     studies have shown that fatigue relates to negative mood and poor health-related quality of     life in older persons.      Tai Chi is an ancient Chinese form of calisthenics that utilizes the body's internal energy     (chi), mind, and breathing; which may be a useful exercise for older adults in increasing     their activity level. A twenty-four of Yang style of Tai Chi is a simple form of Tai Chi that     is particularly well-suited for older adults. This proposed study to investigate the effects     of a Tai Chi intervention on decreasing fatigue level, and increasing level of activity in     healthy older adults.      The investigators research group has focused on the Tai Chi as a strategy to reduce stress     and improve sleep, and their preliminary evidence suggest it strongly affects energy level     and vitality. The investigators are focused on taking this intervention into the community     testing its efficacy. The investigators preliminary data shows that Tai Chi is of benefit to     older adults; however, this study will test whether their research findings are generalizable     to community settings.      Tai Chi-naïve participants from Culver City Senior Center will receive a 10-week Tai Chi. The     investigators will compare this group to a wait-list control group. All subjects will receive     a packet of questionnaires of pre- and post-intervention vitality, fatigue and health-related     quality of life. Subjects will also be given an activity monitor to wear for 2 days before     they start the Tai Chi class and for 2 days after they complete the class, to determine if     there is a change in general physical activity level.   "
158912|NCT01203644|"     The primary objective of this study was to determine the appropriate dose of SKY0402 for the     management of postoperative pain following inguinal hernia repair. This study evaluated the     safety, efficacy, and pharmacokinetics of SKY0402 compared with a 100 mg dose of bupivacaine     HCl for the treatment of postoperative pain in subjects undergoing inguinal hernia repair.     Study drug was administered by surgical wound infiltration at the end of the hernia repair     procedure.   "
158913|NCT01203631|"     This trial is conducted in Europe and North America. The aim of the trial is to assess     disease activity and safety in subjects with moderately to severely active Crohn's disease     (CD) when treated with NNC 0142-0000-0002.   "
158914|NCT01203618|"     The purpose of this study is to evaluate whether therapy with farletuzumab is effective and     safe in the treatment of resectable, non-functioning pituitary adenomas.   "
158915|NCT01203605|"     The European Surgical Outcomes Study (EuSOS) is a multi-centre, international cohort study of     peri-operative care and clinical outcomes for patients undergoing non-cardiac surgery.      Participating centres throughout Europe will contribute routine clinical data describing all     eligible patients who undergo surgery from 4th April 2011 to 11th April 2011. Patients will     then be followed until hospital discharge (or for a maximum of 60 days) for duration of     hospital stay and hospital mortality. Routine clinical data will also be collected for those     patients admitted to critical care at any stage after surgery but during the same hospital     admission. Specific objectives are to describe clinical outcomes and standards of     peri-operative care for patients undergoing non-cardiac surgery in Europe.   "
158916|NCT01203592|"     The study tests the notion that patients suffering from certain types of congenital     myasthenic syndromes are benefitted by the use of Albuterol at doses used in clinical     practice.   "
158917|NCT01203579|"     The purpose of this study is to assess the value of EarlyCDT-Lung test and CT scan both in     lung cancer detection and potential health economic outcomes.   "
158918|NCT01203566|"     LESS laparoscopic appendectomy is associated with less pain than conventional 3-port     laparoscopic appendectomy.   "
159023|NCT01202188|"     The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in     patients with moderate to severe COPD.   "
158924|NCT01203488|"     This multi-site, randomized trial was conducted to determine the safety and effectiveness of     a higher dose of vitamin A and determine if this would increase the rate of survival without     bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights     from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours     of age were enrolled. Subjects were randomized to either the Vitamin A or a control group.     Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on     Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure     rather than placebo injections.   "
158925|NCT01203475|"     This study was a multicenter, prospective cohort study to define postnatal longitudinal     growth for very low birth weight (VLBW) infants. The objectives were: 1) to develop postnatal     growth curves for VLBW preterm infants that would permit an assessment of growth velocity; 2)     to relate growth velocity and nutritional practices (duration of parenteral nutrition, age at     first enteral feeding, and age at full enteral feeding); 3) to compare growth velocity in     infants who are small-for-gestational age (SGA) with infants who are     appropriate-for-gestational age (AGA); and 4) to relate growth velocity to several common,     major morbidities, including chronic lung disease (CLD), nosocomial infection (or late-onset     infection) and necrotizing enterocolitis (NEC). These growth data may be useful in     identifying preterm infants who are growing slowly despite current nutritional support and in     designing and performing clinical trials of nutritional interventions.   "
158926|NCT01203462|"     The purpose of this study is to determine the effect of probiotic supplemented yogurt in     reducing colonic transit time (CTT) in females between the ages of 18-65 years old. Two     yogurts will be administered, one containing a specific strain of probiotic in the     Bifidobacterium genus and the other without the probiotic supplement. It is hypothesized that     subjects receiving the probiotic supplemented yogurt will experience reduced CTT and improved     gastrointestinal comfort and quality of life compared to those receiving the non-probiotic     supplemented yogurt.   "
158927|NCT01203449|"     The primary purpose of this study was to evaluate the accuracy of gestational age (GA)     estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate     obstetric estimates of GA. Secondary purposes were: (1) to compare the accuracy of GA     estimates derived from the NBS, the original Ballard score, and the physical items of the     original Ballard score and (2) to compare these measures of GA and best obstetric estimates     of GA as predictors of survival, morbidity, and hospital stay among infants <28 weeks'     gestation and among very low birth weight infants in general.   "
158928|NCT01203436|"     The purpose of this trial was to determine the efficacy and safety of supplemental     therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce     the probability of progression to threshold ROP and the need for peripheral retinal ablation.   "
158929|NCT01203423|"     This study was an observational study to estimate the prevalence of Persistent pulmonary     hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory     disease.   "
158930|NCT01203410|"     The objective of this study was to describe total bilirubin production in healthy term     infants as a means of understanding the differences in jaundice pigment production associated     with various common clinical circumstances.   "
158931|NCT01203397|"     Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate in the     treatment of superficial varicose veins   "
158932|NCT01203384|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.   "
158933|NCT01203371|"     The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and     Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of     patients with benign prostatic hyperplasia.   "
158934|NCT01203358|"     The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal     (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal     respiratory distress syndrome.   "
158935|NCT01203345|"     A controlled clinical trial was conducted at eight participating centers between January 1,     1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin     group or a control group. There were two phases to the study (see below). During phase 1 the     control infants received infusions of placebo. During phase 2 the control infants received no     infusion therapy.   "
158936|NCT01203332|"     The proposed research will include adolescent and young adult Hispanic/Latino men who have     sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13     ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial     services to the target group. In 10 of the 13 sites, comparisons will be made between     alternative venue-based testing (AVT) and social and sexual network-based interviewing and     HIV testing (SSNIT) strategies to assess which, among these approaches, is the most effective     means for identifying undiagnosed human immunodeficiency virus (HIV) in young, at-risk     Hispanics/Latinos. Three of the sites will focus solely on use of SSNIT for identifying     undiagnosed HIV in our target group of adolescents and young adults. All study participants     will complete an audio computer-assisted self-interview (ACASI) and undergo HIV screening.     Participants with presumptive HIV positive screening results will be referred to the local     AMTU for confirmatory testing, post-test counseling and referrals for linkage to HIV medical     care. Linkage to care for ATN 096 study participants will be conducted in accordance with the     Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of     Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Program (ATN 093), a     collaboration of the CDC and NICHD/ATN, to ensure that youth who test positive for HIV as     part of this protocol are linked with treatment and care.   "
158937|NCT01203319|"     This study is an expanded Phase 2/Phase 3 clinical trial base on the safety data obtained     from the phase 1 clinical trial. The purpose of this study is to further evaluate the     immunogenicity and safety of 60mcg/30mcg recombinant hepatitis B vaccines in people aged 16     and older who failed to respond to routine administration of 10mcg recombinant hepatitis B     vaccines and to explore the optimizing immunizing dose and immune procedure.   "
159083|NCT01201395|"     The purpose of this study is to assess the quality and expected lifespan of fillings recorded     in the DPBRN Reasons for replacement and repair of dental restorations study, and the     factors affecting how long the fillings last.   "
158938|NCT01203306|"     Well differentiated neuroendocrine (NE) carcinomas have low proliferative activity and     conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent     administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic properties.     Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing     metronomic chemotherapy and antiangiogenetic drugs. This is a national, multicenter, phase II     study.   "
158939|NCT01203293|"     The purpose of this project is to implement culturally adapted Cognitive Behavioral Therapy     (CBT) based interventions in general health settings that are delivered to reduce Generalized     Anxiety Disorder (GAD) symptoms, increase levels of functioning, and improve health-related     quality of life.   "
158940|NCT01203280|"     Most boxing injuries occurs over head and neck which leads to potentially acute or chronic     head and neck injuries. Patients with whiplash injury has been reported, reflected by     increased body sway and reduced ability to overcome challenging balance tasks. The purpose of     this research is to evaluate the fitness and balance outcomes between the boxers and the     control group, and boxers undergoing posterior-neck icing effects.   "
158941|NCT01203267|"     The purpose of this study is to evaluate the pathological complete response (pCR) rate in     breast cancer patients treated with weekly paclitaxel plus carboplatin preoperative regimen.   "
172663|NCT00093288|"     This is a placebo-controlled study evaluating the effectiveness of medication in elderly     subjects with Major Depressive Disorder (MDD).   "
158944|NCT01203228|"     In this trial dose reduced conditioning is compared to standard conditioning followed by     allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or     secondary AML.      Conditioning is the very high dose chemotherapy treatment that is given in the days before     the stem cell transplant.      The hypothesis is that a dose reduced conditioning will reduce the non-relapse mortality from     40% to 20% at one year after allogeneic stem cell transplantation.   "
158945|NCT01203215|"     Print-based interventions, specifically interventions that are theoretically-based have been     shown to be effective for individuals. These types of interventions are of particular     importance for those individuals who, due to transportation, work, family, social, or     financial demands have difficulty participating in face-to-face programs. Therefore, we     decided to test 2 such print based programs for women.   "
158946|NCT01203202|"     The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable     and effective in the treatment of premature ejaculation.   "
158947|NCT01203189|"     The aims of this study are to compare the effectiveness of antifungal foam versus antifungal     shampoo and determine patient compliance and satisfaction with both vehicles among African     American females with dandruff practicing less than once weekly hair washing.   "
158948|NCT01203176|"     The prevalence of endometrial polyp is 24% in the general population but is much higher in     postmenopausal women. The incidence of malignant or pre-malignant findings in endometrial     polyps ranges from 2 to 10% in menopausal women.      Removal of endometrial polyps in postmenopausal symptomatic women is the standard of care,     same goes for asymptomatic women with risk factors for endometrial malignancy, however     treatment of asymptomatic postmenopausal women with endometrial polyp but no risk factors is     disputable.      In light of ambiguity in literature regarding the rate of malignant and pre-malignant     findings in polyps in asymptomatic post-menopausal women, the investigators are asking to     conduct a prospective study in order to evaluate and compare the incidence of malignant and     pre-malignant changes in symptomatic and asymptomatic postmenopausal women with endometrial     polyp   "
158949|NCT01203163|"     Three main adverse reactions, namely photosensitivity (reaction that is similar to sunburn),     oesophageal stenosis (narrowing or closure of the food pipe), perforation of the treated area     (a tear or puncture of the tissue), have been identified in research studies evaluating     photodynamic therapy (PDT) with porfimer sodium. Because of the low incidence of the disease     or the variation in the occurrence of these adverse reactions among different indications, it     is difficult to determine the occurrence and frequency of these safety issues in routine     clinical practice.      This post-marketing safety surveillance registry is set-up to evaluate the safety of PDT     using porfimer sodium. A registry allows the collection of data to evaluate real-world     results in the practice of medicine. The registry will monitor the patient's health and any     events, with a main focus on photosensitivity, oesophageal stenosis, and perforation of the     treated area. This registry will involve 500 patients, across 20 to 36 hospitals in the US     and Europe, scheduled to receive an injection of porfimer sodium with PDT for the treatment     of lung cancer, esophageal [food pipe] cancer, or high-grade dysplasia (HGD) (precancerous     change in the food pipe tissue) in Barrett's esophagus.   "
158950|NCT01203150|"     This hypothesis-driven study will investigate effects of physical activity with or without a     nutrient supplement known to increase body lean mass in adults with chronic paraplegia who     have clusters of obesity and obesity-related secondary complications.   "
158951|NCT01203137|"     Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested     as independent prognosticator for predicting long-term prognosis in patients with isolated     severe TR undergoing corrective surgery We attempted to explore whether early postoperative     echocardiography provides additional prognostic information on top of preoperative clinical     and echocardiographic variables.   "
158952|NCT01203124|"     The study will investigate how the dose of AZD8848 and the dosing frequency will affect the     immunological/inflammatory response by measuring the production of biomarkers in blood and     nasal lavage.   "
158972|NCT01202851|"     The goal of this behavioral research study is to compare two different forms of relaxation     programs that will include stretching and relaxation techniques, in order to learn if and how     well they may help to improve physical and emotional well-being. This will be tested in     patients with breast cancer who are receiving radiation therapy. For comparison purposes,     there will also be a group of participants that does not take part in the relaxation     programs.   "
158953|NCT01203111|"     Primary Objective:      To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin     glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week     24 (visit 10).      Secondary Objectives:        1. Percentage of patients with HbA1c < 7% at week 24.        2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event          at week 24.        3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week          0, week 12 and week 24.        4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose /          kg (U/kg) will be calculated at week 24.        5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at          week 0, week 12 and week 24.        6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal          symptomatic, severe and nocturnal severe) will be evaluated during the treatment period.          7-Adverse events.   "
158954|NCT01203098|"     The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b     15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after     elective total hip arthroplasty.   "
158955|NCT01203085|"     The primary goal of this project is to develop and test a Charcot Marie Tooth disease (CMT)     Pediatric Scale for use in evaluation in natural history CMT study.   "
158956|NCT01203072|"     The objective of this study is to assess the efficacy, safety and dose-response relationship     of DU-176b compared with placebo for the prevention of venous thromboembolism in patients     after elective total knee arthroplasty.   "
158977|NCT01202786|"     The aim of the study is in cancer of unknown primary (CUP) patients, to compare the     cost-effectiveness of miRview™ mets test with conventional work-up in identifying the primary     tumor site.   "
172664|NCT00093301|"     The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine     in patients with unstable hemodynamics (shock).   "
158957|NCT01203046|"     Abdominal penetrating trauma represents a frequent cause of consult into emergency rooms in     Venezuela. Accidents and violence at Hospital Miguel Perez Carreño along april 2009 were     represented by gunshots and stabbing wounds which 8th. and 18th cause for medical attention     respectively within a total of 76 cases. Likewise gunshot wounds reach the first cause of     morbility into general surgery services with 21 cases and the stabbing wounds the 12th cause     with 12 cases within the same period.      Early therapy is defined as the antibiotic dose administrated within the first 12 hours after     the trauma. Abdominal cavity contamination by micro-organism is not synonymous of stablished     infection, the extension of contamination and intensity of reaction should be enough in order     to allow the inflammatory focus developing.      Abdominal cavity needs at least 12 - 24 hours of exposure to the infectious material to allow     the stablishment of such infection. Origin and amount of contaminant material influence the     size of inoculated bacteria and the speed that infection develops.      There is not an absolute criteria to determine when intrabdominal contamination progress to     an established infection. Surgeons decides the must adequated therapy according to clinical     history, radiology tests and findings during surgery.      Selected patients for early antibiotic therapy in penetrating abdominal trauma includes those     with traumatic intestinal wounds with less than 12 hours of evolution and those with     gastroduodenal wounds lesser than 24 hours as well.      There are different antibiotics indicated for intrabdominal infections. Ertapenem is a low     resistance carbapenem with a broad spectrum into microbial flora presenting in penetrating     abdominal trauma. Its media life and blood therapeutic levels allows the use of an unique     dose within the first 24 hours of trauma.      This research protocol has been designed according to established patterns for clinical     investigation and our goal is to achieve criteria in decision making about antibiotic     administration in patients with penetrating abdominal trauma and evaluate the security of an     Early short term antibiotic therapy with Ertapenem 3 days vs 7 days, decreasing hospital     costs related to indiscriminate use of antibiotics.   "
158958|NCT01203033|"     Treatment options and clinical outcomes for acute myeloid leukemia (AML) have not improved     for more than 40 years. AML patients are still suffering from receiving costly, ineffective     chemotherapy treatments with very high chances of bad side effects. The purpose of this study     is to take a look at leukemia cells to see if the investigators can learn what makes them up     and makes them aggressive and hard to treat. We want to use this information to create new     treatments that the investigators hope are more effective and less harmful for AML patients.      Newly diagnosed, relapsed or refractory (post induction therapy) AML patients that are 18     years of age or older will have bone marrow and blood samples taken for their regular AML     treatment. When these tests are done during their treatment the investigators will need to     get some extra blood and bone marrow to do this research. The patients will not be asked to     have an extra needle stick or bone marrow biopsy to get these samples. The patients will have     the same number of blood and bone marrow tests whether they participate in this study or not.     We will only need to get about two teaspoons of blood and two teaspoons of bone marrow each     time the patient has these tests during their regular AML treatment. The research the     investigators do with these sample will not decide or change the care the patients get for     their AML.   "
158959|NCT01203020|"     This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT)     followed reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine     in patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas.   "
158960|NCT01203007|"     The purpose of this study is to assess whether a tailored diet, eliminating antigens to which     IgA nephropathy patients have demonstrated sensitivity, will have an effect on proteinuria,     renal function and other immunological variables.   "
158961|NCT01202994|"     Alzheimer's disease (AD) is the most common cause of progressive cognitive decline in the     United States. AD is characterized by severe impairments in learning, memory and other     cognitive abilities that significantly interfere with daily functioning. The neuropathologic     hallmarks of AD consist of neuritic plaques, neurofibrillary tangles, and selective neuronal     cell loss. Amyloid plaques, which contain Abeta protein, are believed to play an integral     role in the development of AD. Elevated levels of Abeta in the brain are also correlated with     cognitive decline.      Alzheimer's (AD) develops insidiously, making it difficult to identify early, yet treatment     is most effective when begun during the early stages of the disease. Thus, it has become     important for researchers to identify markers of early AD. This project will examine the     relationship between four potential markers that may indicate the early development of AD:        1. Mild cognitive impairment (MCI)or normal cognition        2. Practice effects        3. Amyloid plaque binding on 18F-PIB PET        4. Glucose hypometabolism on FDG PET      This project will recruit 25 subjects from an ongoing community-based study of memory and     practice effects in cognitively normal, community-dwelling individuals who are age 65 and     over (NIA #5K23AG028417-05). Each subject will undergo positron emission tomography (PET)     with both 18F-Flutemetamol and FDG.      The overall objective of this companion project is to study the biodistribution and binding     of 18F-Flutemetamol in these subjects using PET imaging, which will provide biological     evidence to support the overall hypothesis that failure to benefit from practice on a     learning paradigm is an early marker of AD.   "
158973|NCT01202838|"     The purpose of this study is to study composites of bioactive glass and methylmetacrylate     with glass fibre reinforcement in cranial bone defect reconstruction.   "
159098|NCT01201200|"     The purpose of this study is to determine whether patients with obstructive sleep apnea have     any changes in right ventricular function evaluated by three dimensional echocardiography.   "
158962|NCT01202981|"     This study will assess the impact of IOL glistenings on visual quality and function in     patients implanted with a single-piece AcrySof intraocular lens (IOL) that exhibits     glistening formations. The primary objective is to determine if random light scattering     (measured by C-Quant)correlates with severity of glistenings, other objective measures of     visual function (visual acuity, low contrast visual acuity, low contrast visual acuity with     glare), and subjective measures of patients' perceptions of their visual quality after     cataract surgery (quality of life survey, reports of symptomology and satisfaction).   "
158963|NCT01202968|"     It was well known that long term intubation caused a various kind of abnormal presentations     of dysphagia such as the increased aspiration risk, the decreased gag reflex, mucosal     pathology, the airway stenosis and so on. It was thought that the freezing and impaired     proprioception to be developed as a result of dis-use around the pharynx and the larynx while     intubation was one of the reason.      Preemptive swallowing manual stimulation applied on the oral cavity to avoid the vicious     cycle of dis-use was reported to improve dysphagia after extubation.      Neuromuscular electrical stimulation have been utilized for a wide variety of dysphagia of     multiple causes of neuro-muscular disorder.      Supposing that preemptive transcutaneous neuromuscular electrical stimulation to be delivered     to the muscles of being involved in swallowing could decrease the degree of dis-use during     intubation so that it could reduce the occurence and severity of dysphagia developed after     extubation, the investigators plan to perform randomized prospective double blind placebo     controlled clinical interventional study.   "
158964|NCT01202955|"     The goals of this within-subject pilot study are: (1) assess the feasibility and safety of     administering the Catechol-O-Methyl-Transferase (COMT) inhibitor, tolcapone, to smokers, and     (2) explore whether tolcapone may reduce abstinence-induced cognitive and affective symptoms     that promote relapse. A secondary exploratory goal is to assess whether these effects may be     more pronounced in smokers who carry a high risk COMT genotype for smoking relapse: COMT     val/val.   "
158965|NCT01202942|"     The proposed research extends previous research on Quest® cigarette smoking behavior by     testing whether compensatory smoking occurs as cigarette nicotine level decreases, and     whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested in     210 smokers who report smoking at least 15 cigarettes per day and have been smoking for at     least five years and are not currently interested in quitting, but interested in trying a new     cigarette product. Participants will be randomized to one of three conditions: 1) smoke their     own preferred brand (control group); 2) smoke Quest® cigarettes in progressively decreasing     cigarette nicotine level (step-down); or 3) Quest® cigarette non-step-down condition, where     they will smoke Quest® cigarettes in a random order. The study will consist of 4 stages     beginning with a 5-day preferred own brand cigarette smoking phase for all participants,     followed by one of the three cigarette conditions. For those smoking Quest® cigarettes,     cigarette nicotine level will change every 10 days, either in a step-down or random fashion.     The primary behavioral outcome is smoking topography, a quantitative measurement of smoke     exposure. Alveolar carbon monoxide (CO), a validated assessment of smoke exposure, and urine     samples to assess carcinogen exposure, specifically NNAL     (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and 1-HOP (1-hydroxypyrere), and exhaled     breath condensate will also be collected at the laboratory visits. At the initiation of the     study, participants will view the Quest® print advertisement and complete a survey related to     product expectations in order to determine the impact marketing and advertisement has on     beliefs, attitudes and behaviors related to Quest® cigarettes.   "
158966|NCT01202929|"     High Resolution Manometry is a new technology that utilizes 36 solid state sensors on a thin     catheter spaced at 1-cm intervals. One can more effectively measure the pressure of the     esophagus. It includes a sophisticated software to display the pressures data as color     topography plot using time, length of the esophagus and pressure within the entire esophagus.     It is unclear if this technology improvement actually correlates with patient's symptoms.   "
158967|NCT01202916|"     Congenital heart diseases (CHD) are the first cause of congenital malformations with an     incidence of 8 for 1000 births. Within the two past decades prenatal diagnosis has had a     great impact on CHD prevalence. France was the first country to show the impact of prenatal     diagnosis on the lowering prevalence of the most severe CHD, the hypoplastic left heart     syndrome. Since the 90's, great advances in pediatric cardiac surgery, intensive care and     cardiac catheterization have led to lower mortality and morbidity in this population.     Prevalence of  GUCH , grown-ups with congenital heart disease has thus been significantly     increasing. For all these reasons and as the investigators can also see in other many chronic     diseases, new questions about the quality of life of these patients arise among patients,     parents/future parents, doctors, patients associations, and public health organizations. In     2007 French government promoted a national public health plan for improvement of the quality     of life among patients suffering from chronic illnesses. First step of such a program is to     correctly evaluate this quality of life. Indeed the concept of quality of life (QoL)     remains subjective and difficult to appreciate and measure. Its analysis requires the use of     validated questionnaires. Few questionnaires are available in Europe, especially in     pediatrics. Few studies in this population have been led and no comparative study to a     control randomized group has been published. The investigators study aims to analyze in the     investigators tertiary care center in pediatric cardiology the QoL among 8 to 18 year old     French patients with CHD using a validated questionnaire (Kidscreen™) and to compare it to     same aged healthy children. The investigators secondarily intend to :- validate the French     version of one reference pediatric QoL questionnaire used in most publications in the USA     (PedsQL™). - compare the QoL to the severity of the CHD using a published semi-quantitative     score.- compare the QoL to the severity of the CHD using the results of routine exercise     tests (VO2 max) performed routinely in the investigators center. The investigators hypothesis     are that :- Quality of life of most common and not severe CHD is close to that of healthy     children. - QoL of severe CHD is not so well correlated to severity of CHD.- PedsQL™ is a     simple questionnaire which can be used in France in routine follow-up of children with CHD.   "
158968|NCT01202903|"     This study will assess the efficacy, safety and tolerability of omalizumab, compared to     placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic     asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4     therapy.   "
158969|NCT01202890|"     This study will test the feasibility of combining 3 drugs, Revlimid with Doxil and     Bevacizumab,and gather preliminary data on the potential activity of the combination in     patients with platinum resistant/refractory ovarian cancer.   "
158970|NCT01202877|"     The goal of this clinical research study is to learn if the combination of PKC412 (also     called Midostaurin) and 5-azacytidine can help to control refractory or relapsed acute     leukemia and MDS. The safety and best dose of the combination of the drugs will also be     studied.   "
159099|NCT01201187|"     This study will evaluate clinical efficacy and safety of treatment with YY-162 in children     with ADHD   "
158974|NCT01202825|"     The purpose of this study is to assess the safety and tolerability of TMC647055 both after     increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after     multiple oral doses in fed conditions at increasing dose levels administered for 6 days, as     well as to assess the pharmacokinetics of TMC647055 after increasing single oral doses from     100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed     conditions at increasing dose levels administered for 6 days and to assess the effect of food     on a single oral dose of TMC647055 at one dose level, all in healthy participants. In     addition, the safety, tolerability, pharmacokinetics and the antiviral activity of TMC647055     will be determined after 6 days of consecutive dosing and of TMC647055 and TMC435 after 10     days of co-administration in chronic hepatitis C virus infected patients. Pharmacokinetics     means how the drug is absorbed into the bloodstream, distributed in the body and eliminated     from the body. TMC647055 is being investigated for the treatment of chronic hepatitis C     infection.   "
158975|NCT01202812|"     The purpose of the study is to determine the effectiveness of LOVAZA (fish oil capsules) to     decrease inflammation in children and adolescents with Sickle Cell Disease (SCD). It has been     found that besides the damage caused by sickle red blood cells themselves, the inflammatory     response that occurs in SCD patients could potentially play a significant role in the     occurrence of painful episodes or pain crises. The investigators will also study whether the     subject/caregiver feels that there is an improvement in the child's quality of life by taking     the medication. Besides the effect of LOVAZA on inflammation,the investigators are also     testing whether the drug will have a beneficial effect on blood clotting ability (which is     known to be increased in SCD) and on the anemia (low red blood cells) that is part of the     disease entity.   "
158978|NCT01202773|"     The primary purpose of this study is to help answer if LY2127399 is safe and effective in the     treatment of rheumatoid arthritis in patients with an inadequate response to one or more     Tumor necrosis factor-alpha (TNF α) inhibitors.      This study is comprised of 2 periods:      Period 1 - 24 week blinded treatment      Period 2 - 48 week post treatment follow up   "
158979|NCT01202760|"     The primary purpose of this study is to help answer if LY2127399 is safe and effective in the     treatment of rheumatoid arthritis while with or without Background Disease-Modifying     Anti-rheumatic Drug (DMARD) Therapy.      This study is comprised of 2 periods:      Period 1 - 24 week blinded treatment      Period 2 - 48 week post treatment follow up   "
158980|NCT01202747|"     The objective is to evaluate the feasibility of using additional screening methods to     optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure     therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian     gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and     chalazia. The screening methods include diagnostic expression of the meibomian glands and     interferometry assessment of the tear film.   "
158981|NCT01202734|"     The purpose of the study is to evaluate the pharmacokinetics and safety of 3 single doses of     Methylphenidate HCl in healthy Japanese adult male volunteers.   "
158982|NCT01202721|"     The purpose of this study is to determine whether long-term treatment with a beta-blocker     (BB) such as atenolol and/or an angiotensin receptor blocker (ARB) such as telmisartan, given     to adult patients with bicuspid aortic valve (BAV) disease (aortopathy) reduces the widening     (dilatation) of the aorta from its baseline size.   "
158983|NCT01202708|"     This study is designed to assess the safety, efficacy and dialytic capabilities of     hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in     comparison to conventional hemodialysis.   "
158984|NCT01202695|"     Primary:      • To compare the safety profile of a single intravenous administration of AVP-21D9 as     compared with Placebo      Secondary:        -  To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9        -  To evaluate the immunogenicity of AVP-21D9   "
158985|NCT01202682|"     The purpose of this study is to gather ECG data during normal activity, exercise, and sleep     from normal subjects with or without well-controlled epilepsy. This normal subject data will     serve as true negative (i.e., no seizure occurring) challenge data for testing cardiac     based seizure detection algorithms.   "
158986|NCT01202669|"     The purpose of this study is to collect continuous observational data during a clinical     Epilepsy Monitoring Unit evaluation.   "
158987|NCT01202656|"     This a trial designed to test whether granulocyte colony stimulating factor (G-CSF, Neupogen)     can increase the rate of embryo implantation following IVF and embryo transfer. Preliminary     data at the Center for Human Reproduction(CHR) and elsewhere suggest that intrauterine     infusion of G-CSF can improve endometrial development and can increase implantation rates of     embryos.   "
158988|NCT01202643|"     The purpose of this study is to investigate the effect of G-CSF on endometrial thickness in     women who have failed reaching minimal endometrial thickness by standard treatments, to     assess how many reach embryo transfer and what implantation and pregnancy rates are in     comparison to control patients. The study will be conducted in women undergoing transfer of     previously cryopreserved embryos or undergoing transfer of embryos from donor eggs.   "
158989|NCT01202630|"     The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for     prevention of recurrent Clostridium difficile infection.   "
158990|NCT01202617|"     The purpose of the study is to determine whether the Seroquel XR treatment for 6 months     improves the relapse prevention in schizophrenic outpatients   "
158991|NCT01202604|"     The primary objective of the study is to evaluate the efficacy of administered maintenance     treatments in bipolar disorder I and II, defined as the percentage of patients who experience     a relapse episode during the first 9 months after a mood event (manic or depressive).   "
158994|NCT01202565|"     There is clearly a need for further data on the efficacy of biologic agents in the treatment     of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports     can be found, but no published data exists from non-interventional studies, such as     post-marketing observational studies (PMOS) that reflect routine clinical practice.      The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the     treatment of nail and scalp psoriatic lesions in routine dermatologic practice.   "
158995|NCT01202552|"     One-site dose sparing intradermal influenza vaccination in elderly had been studied but     resulted in unsatisfactory outcomes. The investigators evaluate the safety and immunogenicity     of the two-site intradermal injection of influenza vaccine containing all 6 and 12 micrograms     of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram     HA/strain intramuscular vaccine respectively) in elderly over 60 years of age. An influenza     vaccine administered intramuscularly at the standard dose is used as the reference vaccine.   "
158996|NCT01202539|"     The purpose of this study is to assess the ability of a modified thermoplastic mask system in     keeping an individual head stationary for a predefined amount of time. The investigators hope     to know if the modified mask is study enough, and also if the modification on the mask will     allow the investigator see and track the individual's movement underneath the mask by means     of a camera that can detect light reflected from the individual. Participants will lay down     on their backs and their heads will be held in place with the mask system for approximately 1     hour.   "
158997|NCT01202526|"     Gastric bypass surgery induces remission of diabetes within days after surgery, before     significant weight loss. The aim of the study is to examine whether improved insulin     sensitivity of muscle and liver contributes to the immediate diabetes resolution.   "
159062|NCT01201668|"     The purpose of this study is to document by survey the occurence of tooth pain present 3     months and 6 months after root canal therapy in the patients recruited for the DPBRN     Peri-operative tooth pain study. This study will access the feasibility of obtaining 3     month and 6 month follow-up data on the patient enrolled in the DPBRN Peri-operative tooth     pain study.   "
159262|NCT01199055|"     The primary objectives of this study are to evaluate the safety and tolerability of CS-7017     administered orally twice a day in combination with carboplatin and paclitaxel, and to assess     the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.   "
158998|NCT01202513|"     Vitiligo is an acquired depigmentation disorder of great cosmetic importance, affecting 1-4%     of the world's population. Phototherapy and topical agents such as corticosteroids,     calcineurin inhibitors, and vitamin-D derivatives are basic treatment modalities have been     used in vitiligo but there is still no effective and safe treatment for this disease.     Resistance to therapy, treatment complications and recurrence after treatment are the major     problems of the current treatments.      There are no clinical studies of use of Bimatoprost in treatment of vitiligo, as it is     supposed to cause more hyperpigmentation and hypertrichosis as compared to other topical     prostaglandin analogues; hence, the investigators decided to use it in treatment of localized     vitiligo.   "
158999|NCT01202500|"     Toxoplasmosis is a benign disease in healthy adults, but can be serious in the case of     contamination during pregnancy: the parasite can pass through the placental barrier and     infect the foetus. The severity of congenital infection varies, but in France, where maternal     seroconversions during pregnancy are treated, the manifestations of the disease are often     infraclinical at birth and only appear during the first years of life in the form of     retinochoroiditis. In order to prevent long-term sequellae, children with confirmed     congenital toxoplasmosis (TC) are treated with pyrimethamine combined with either     sulfadiazine or sulfadoxine (Fansidar®). The relative efficacy of these two combinations has     not yet been evaluated. Moreover, there is no consensus about the duration of the treatment,     which varies, in France, from 12 to 24 months depending on the centre. Compared with the     duration of parasitaemia in non-treated children, which can persist for up to 4 weeks, these     treatments are very long. They are also far longer than the 3 months of treatment, which is     in accordance with the World Health Organization (WHO) recommendations, given in Denmark to     infants identified as being infected with the parasite during neonatal screening. A one-year     treatment was developed in the United States, but it mainly concerns only symptomatic     children, given the absence of generalised screening in the United States of America (USA).     We have no arguments to justify the use of treatments lasting one year or more in children     with asymptomatic or mildly-symptomatic TC. As these treatments carry certain risks, which     may be severe, notably with regard to haematological or skin conditions, they have to be     supervised closely with biological tests, which adds further constraints for both the     children and their parents and increases the cost to health care systems.   "
159000|NCT01202487|"     Minor lacerations are a commonly treated injury in the paediatric emergency department . Over     the past decade, standard closure of these lacerations has evolved from suture repair to     closure with tissue adhesive (also referred to as skin glue). Local anaesthetic is not     routinely used during application of skin glue as it was with sutures. There are, however,     several potential advantages to pre-treating wounds with topical LET     (Lidocaine-Epinephrine-Tetracaine), a liquid gel with anaesthetic and vasoconstrictive     properties. Some believe LET can improve patient comfort, increase the ease of glue     application, and lead to better healing when used on lacerations being repaired with tissue     adhesive. This study aims to address the question of whether or not pre-treatment with LET     improves outcomes in minor lacerations repaired with skin glue. The primary hypothesis is     that pre-treatment of minor lacerations with LET will decrease pain (as measured on a Visual     Analog Scale) during repair with tissue adhesive.   "
159001|NCT01202474|"     Primary Objective:      Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level < 8% (in     patients of 6-12 years old) and HbA1c level < 7.5% (in patients of 13-17 year old) at 6 and     12 months of treatment      Secondary Objectives:      Change in HbA1c level at 6 and 12 months of treatment Monthly rate of hypoglycaemia/per     patient from the baseline to the end of the study Change in daily dose of glargine and     glulisine at 6 and 12 months of treatment.   "
159002|NCT01202461|"     This study is designed to report 3-year result of triple therapy of vitrectomy, intravitreal     triamcinolone and macular laser photocoagulation for intractable diabetic macular edema.      Previously author reported 1-year result(Am J Ophthalmol. 2007 Dec;144(6):878-885. Epub 2007     Oct 15.).   "
159003|NCT01202448|"     This study is to evaluate the incidence of central nervous system (CNS) relapse or metastasis     in patients with diffuse large B-cell lymphoma.   "
159004|NCT01202435|"     The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a     pregabalin controlled release tablet as compared to multiple doses of the pregabalin     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin     controlled release tablet as compared to multiple doses of pregabalin immediate release     capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin     controlled release tablet as compared to multiple doses of the pregabalin immediate release     capsule.   "
159005|NCT01202422|"     The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two     pregabalin controlled release tablets as compared to multiple doses of the pregabalin     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two     pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate     release capsule and 3) evaluate the safety and tolerability of multiple doses of two     pregabalin controlled release tablets as compared to multiple doses of the pregabalin     immediate release capsule.   "
159007|NCT01202396|"     Pouchitis is a common complication following proctocolectomy with ileal pouch anal     anastomosis (IPAA) in patients with ulcerative colitis (UC). It affects the quality of life     and can become a chronic problem. The aetiology of pouchitis is not completely understood. A     crucial role of the intestinal microbiota has been suggested, but no causative agent has been     identified so far. Furthermore, the defensin expression and the epithelial integrity are     altered in inflammatory bowel diseases and may play an important role in the development of     intestinal inflammation. Therefore, it has been hypothesized that the interaction between an     altered microbiota composition, a defective epithelial integrity and changes in innate     defense parameters such as defensins has a pivotal role in the development of pouchitis in UC     patients.   "
159036|NCT01202019|"     This study is designed to assess the impact of exercise and supplementation on measures of     fitness, function, and cardiovascular disease risk factors/modifiers in individuals with     spinal cord injury (SCI). The primary purpose of this study is to improve fitness and     function, reduce cardiovascular disease risks, and enhance oxidation of dietary and body fats     in persons with chronic tetraplegia through acute exercise, exercise conditioning, and     dietary supplementation. This study will test the hypothesis that timing of supplementation     with regards to exercise bout ('intervention/placebo') affects fitness, function, lipid     profiles, lipid oxidation, and inflammatory markers after acute exercise and chronic     conditioning.   "
159037|NCT01202006|"     The purpose of this study is to determine whether a structured diagnostic-therapeutic     strategy to detect and treat previously unrecognized (or unestablished) heart failure in     primary care will improve the functional capacity, quality of care, the quality of life, and     eventually the prognosis of these patients.   "
159008|NCT01202383|"     The proposed study is a 12-month double-blinded, randomized, placebo-controlled trial to     determine if the impact of treating water with chlorine at the household level is effective     in preventing diarrhea among young children. For more than a century, chlorine has be used to     treat water in municipal systems in developed countries. Lack of infrastructure has prevented     its use in lower-income settings. NaDCC is a tablet form of chlorine that has been used for     more than 30 years in emergencies and has recently been approved for routine treatment of     drinking water by the WHO and US Environmental Protection Agency. The placebo will consist of     the food-grade ingredients in the effective tablet, without the chlorine. Study participants     will be supplied with tablets (intervention or placebo) and instructed to use the same to     treat their water daily. Monthly follow-up visits will assess diarrhoea morbidity and     weight-for-age Z scores in <5s. Chlorine residual and bacteriological quality of water stored     in the home will be measured each month. The study will also assess the impact of the     intervention on absenteeism from school and work and on health care expenditure for     diarrhoea.   "
159009|NCT01202370|"     Camptothecins are a potent class of anticancer drugs that inhibit DNA Topoisomerase I. While     seen strictly as cytotoxic compounds, camptothecins are actually also targeted agents,     inhibiting DNA-Topoisomerase I (Topo I) cleavable complex. First and second generation     cogeners are hampered by a labile α-hydroxy-δ-lactone pharmacophore, which hydrolyzes to     yield the inactive carboxylate form of the drug. AR-67     (7-t-butyldimethylsilyl-10-hydroxycamptothecin) is a third generation analog engineered to be     stable in blood and highly potent. Its enhanced stability results from two factors: (1) AR-67     is highly lipophilic, partitioning into lipid bilayers, thus protecting it from hydrolysis in     the aqueous milieu of the bloodstream, and (2) the 10-hydroxy functionality of the drug     effectively ablates the high affinity interactions of the carboxylate drug form with albumin,     which has been previously shown to diminish the levels of the active lactone species in the     circulation. In a recently completed phase I trial, AR-67 showed over 85% lactone stability     at all time points studied, and was well-tolerated with grade 4 thrombocytopenia, neutropenic     fever and grade 3 fatigue as dose limiting toxicities. The MTD was established at 7.5     mg/m2/day in a daily times five of a 21 day cycle. Preclinical data indicates that AR-67 may     concentrate in tumors for a prolonged period of time, compared to plasma clearance of the     drug, a phenomenon which has the potential to improve efficacy and decrease toxicity of this     compound. What is not known is the optimal dose and schedule of AR-67 needed to produce high     tumor penetration, and modest systemic exposure. This pilot proposal seeks to study AR-67 in     a novel dosing schedule and to evaluate the feasibility of performing tumor biopsies to     determine the tumor half-life of AR-67 in humans. By using multiple tumor biopsies, as a     means to document penetration of tumor tissue by AR-67, and compare that to plasma clearance     of the drug, the investigators will establish direct pharmacokinetic evidence that AR-67     hits the target. The investigators propose that a rigorous evaluation of drug penetration     into the tumor should be considered, in addition to the MTD, when determining dose of new     experimental compounds. Dose-tumor concentration relationships should be established early in     the course of clinical development to provide data for rational selection of the phase-II     dose. This pilot study will provide important preliminary data to establish the feasibility     of this approach for future study. If successful, tumor half life will be used to develop an     optimal biologic dose in a phase I trial using this schedule of AR-67. Optimal biologic     dosing could become a new standard for dose escalation studies with this compound and other     cytotoxic drugs that have specific biologic targets in the future.   "
159010|NCT01202357|"     A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case     management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving an     additional year of case management, or (2) terminating case management for the next 12     months. The current study aims to investigate whether an additional year of case management     in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms,     quality of life and health economics.   "
159011|NCT01202344|"     The purpose of this study is to develop a computer program that might be able to accurately     assess the risk of artery re-narrowing following angioplasty or stenting based on computer     images. After angioplasty (a procedure to re-open narrowed or blocked blood vessels) the     patients will have extra images taken in order to assess the results of the procedure; which     will then be used to see whether or not these images can help predict outcomes such as the     patient having to come back to the hospital to have the procedure done again.   "
159012|NCT01202331|"     Mass antimicrobial administrations have been remarkably successful in reducing the prevalence     of the ocular strains of Chlamydia that cause trachoma. Repeated distributions progressively     lower the prevalence of infection, and in some cases may even result in local elimination.     Mass treatments cannot be continued forever, due to concerns about cost and antibiotic     resistance. The hope has been that other measures such as latrine construction and hygiene     programs would prevent infection from returning. Unfortunately, no non-antibiotic measure has     yet demonstrated an effect on infection.        1. We hypothesize that Chlamydial infection will return to communities when treatment ends.        2. We hypothesize that infection will be completely eliminated in all communities treated          for seven years.        3. We hypothesize that identifying and treating clinically active cases among preschool          aged children will delay or even prevent reemergence at a far lower cost than mass          treatment of all individuals.   "
159013|NCT01202318|"     This study will compare the diagnostic accuracy of Card 28 stroke protocol to Card 28 and     Cincinnati Stroke Scale, when used by emergency medical dispatchers to interrogate a 911 call     suggestive of stroke.      The authors hypothesize that a combination of Card 28 plus the Cincinnati Stroke Scale (CSS)     will improve the diagnostic accuracy of emergency medical dispatchers for stroke.   "
159014|NCT01202305|"     HIV medicines have led to dramatic improvements in health. However, there remains a concern     for potential drug toxicities, cost of drugs, and need for life-long treatment. In addition,     research has found that health is not completely restored in HIV-infected patients, even if     they have been taking effective HIV medicines for a long time. This may be due to direct     drug-toxicity, continued replication of the virus, and/or inflammation of the body in     response to the virus. Therefore, a more complete understanding of how HIV stays in the body     is necessary.      Recent research has shown that one of the places that HIV can stay in the body is in     lymphatic tissues such as lymph nodes (even in patients who have been taking HIV medicines     for a long time). In addition, the amount of damage to the lymphatic tissues can predict how     the immune system (CD4+ T cell count) will respond to therapy.      The investigators therefore propose a study in which lymph nodes from the groin area will be     removed, with the goals of: 1) seeing how much HIV is in lymph nodes and 2) seeing how much     damage has happened to the lymph node architecture.   "
159015|NCT01202292|"     The overall goal of IMOAP study is to assess whether the efficacy of the healthcare     professionals' usual practices, together with a motivational group intervention (delivered by     a nurse trained by an expert psychologist), is more effective than an isolated traditional     intervention on weight loss and its maintenance in overweight and obese patients.     Furthermore, the study will evaluate whether this result has a positive impact on quality of     life, changes in eating habits, and a reduction in the associated cardiovascular risk factors     and overall cardiovascular risk.   "
159016|NCT01202279|"     The purpose of this study is to determine if treatment with Mucinex D lowers the use of     antibiotics in the treatment of upper respiratory infection when compared to placebo   "
159017|NCT01202266|"     The primary purpose of this study is to evaluate the safety, tolerability and     pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers   "
159018|NCT01202253|"     The purpose of this study is to describe the real world effectiveness of anidulafungin in     clinical practice in a large Liver Unit in the United Kingdom.   "
159019|NCT01202240|"     Estimate the effect of oral ketoconazole administration (400 mg once daily over 3 days) on     the pharmacokinetics (process by which the drug is absorbed, distributed, metabolized, and     eliminated by the body) of single 10 mg dose of tasocitinib (CP-690,550) in normal healthy     volunteers.   "
159024|NCT01202175|"     The investigators aim to evaluate subjects at high risk of future development of     hypertension, those with a family history of hypertension and/or that already have high     normal(SBP 120-139 mmHg or DBP 80-89 mmHg) blood pressure. The investigators plan to     investigate whether these subjects have the same markers (such as microscopic protein in the     urine or C-reactive protein in the blood) in the blood and urine that people with high blood     pressure have, and whether they are improved before and after taking the beta-blocker     nebivolol.   "
159038|NCT01201993|"     The investigators hypothesis is that a significant number of patients may remain without     specific cause and have recurrent syncope with its associated physical and mental morbidity.   "
159025|NCT01202162|"     Goals for ambulatory surgery include providing optimal surgical conditions while ensuring a     rapid early recovery without side effect. Dexter et al1 concluded in a meta-analysis that     Desflurane can reduce the extubation time when compared to Sevoflurane. This potential     benefit of Desflurane can be especially attractive in short ambulatory cases performed with     general anesthesia with a laryngeal mask airway.      Although some studies have not shown a difference on perioperative cough and laryngospasm     between Desflurane and Sevoflurane at clinically relevant doses.It has been reported in the     literature that Desflurane causes cough4 and many providers avoid using Desflurane with a LMA     (laryngeal mask airway) in the ambulatory setting. In this study we will also evaluate, as a     secondary outcome, the presence and severity of perioperative cough and laryngospasm.      Previous investigators have demonstrated a more rapid resumption of normal daily activities     after ambulatory surgery in patients anesthetized with Desflurane when compared with     Sevoflurane.these investigators suggested a better quality of recovery when Desflurane is     used probably due to a lower lipid solubility of Desflurane. We will also evaluate quality of     recovery as a secondary outcome using a validated instrument.      Significance:        1. A more rapid awakening, especially, in a fast and high turnover cases that are performed          with LMA can lead to a more cost effective utilization of operating room time        2. It has been reported that Desflurane causes more cough than Sevoflurane and          Anesthesiologists avoid using Desflurane with LMA cases, this study will reinforce that          there is no difference.   "
159026|NCT01202149|"     This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic     dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus) cream     1% and Hylatopic™ Plus Emollient Foam™ in subjects with atopic dermatitis. Subjects will     apply Elidel® (pimecrolimus) cream 1% twice daily for four weeks on a chosen target     eczematous area located on one side of the body and then apply Hylatopic™ Plus Emollient     Foam™ three times daily on a symmetrical target eczematous area on the opposite side of the     body. A randomized list will be created to determine which side the subject applies each     medication.      Subjects will be consented prior to any study evaluations or procedures. After signing the     consent and meeting all inclusion/exclusion criteria, qualified and enrolled subjects will     apply study medication (Elidel® and Hylatopic™ Plus Emollient Foam™) to chosen affected areas     for four weeks. Photography will be used to record the location of target lesions at the     baseline, week two and week four/final visits. Subject's disease status will be assessed by     two methods: 1) Physician's Global Assessment (PGA) and 2) Target Lesion Symptom Score (TLSS)     (see sections V.B.2 and V.B.3). PGA as well as TLSS will be made at baseline (Day 0), week     two (Day 14 +/- 2 days) and week 4/final visit (Day 28 +/- 2days) visits for each of the     target lesions. Half scales (i.e. 0.5, 1.5) will not be used. The presence or absence of skin     atrophy and telangiectasias will be noted at each study visit as well.      Additionally, subjects' self-assessments of their perception of degree of disease and itching     severity control will be collected at each visit for each target lesion. This assessment will     be made using a four point scale and Itch Severity Scale (visual analogue score) respectively     (see section V.B.4). Lastly, subjects will take a Product Preference Survey at week 4/final     visit (Day 28 +/- 2days). Parents (or guardians) will moderate Product Preference Surveys for     subjects that are younger than 12 years of age.   "
159027|NCT01202136|"     The aim is to propose and prospectively validate a diagnostic approach and model for     prediction of mucinous versus non-mucinous, and malignant versus non-malignant pancreatic     cysts using a combination of clinical, radiologic, and biomarker characteristics.   "
159028|NCT01202123|"     The purpose of this study is to evaluate the safety and efficacy of highly purified (HP)     menotrophine to Korean women.   "
159029|NCT01202110|"     The primary objective of this study is to determine in patients with traumatic brain injury     (TBI) the safe dosing of propranolol. Safety will be measured by episodes of bradycardia     (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or     decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) that are refractive     to Brain Trauma Foundation guidelines for treatment. A no-treatment arm will establish the     number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to     treatment that occur without propranolol.   "
159030|NCT01202097|"     The primary objective will be to compare the formulations regarding their impact on the     pulmonary function of persistent asthma patients and the secondary objective will be the     clinical control of the disease's symptoms.   "
159031|NCT01202084|"     The primary objective will be to compare the impact of the study formulations on pulmonary     function in persistent asthma carriers.   "
159032|NCT01202071|"     The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg,     20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5     days to healthy adult male Japanese participants. This was a single-center, open-label,     randomized, four-treatment, four-way crossover study.   "
159033|NCT01202058|"     As a result of the implementation of Protocol Am3.0, the design and objective of the NEVO II     trial were changed to focus on the safety follow-up of the 103 NEVO™ subjects. Although this     trial started interventional, the remainder of the study will be observational.      The objective of this prospective, observational study is to ensure the safety and the     wellbeing of subjects treated with the NEVO™ SES.   "
159034|NCT01202045|"     The purpose of this study is to assess the value in terms of sensitivity, specificity and     likelihood ratio of the stress echocardiography in the screening of pulmonary arterial     hypertension in patients with systemic sclerosis and indirect signs of pulmonary arterial     hypertension.   "
159035|NCT01202032|"     This is an open-label, multicenter dose-escalation phase I study using a 3+3+3 design (i.e.,     3 to 9 patients per dose level) in patients with mRCC or others advanced refractory solid     tumors. Enrolment will be performed to include approximately ½ of patients with mRCC.      The primary endpoint is the occurrence of limiting toxicities leading to definitive     discontinuation of the study drugs during the first 24 weeks in absence of progression of the     disease.      Secondary endpoints included the occurrence of Dose Limiting Toxicities (DLTs) evaluated     during the first two cycles; overall response rate, 6-months progression-free survival rate     and Pharmacokinetic assessments.   "
159100|NCT01201174|"     In the present study the investigators are going to explore the oxidative status of HS-RBC     and its contribution to hemolysis   "
185285|NCT00262054|"     The purpose of this study is to determine whether bivalirudin given during PCI is associated     with better outcomes compared to un-fractionated heparin.   "
159039|NCT01201980|"     This study is aimed to evaluate response rate of the antihypertensive treatment with a     calcium antagonist in real life practice, to evaluate patients' quality of life and to     collect the following Serbia-specific epidemiology data on hypertension: demographic data,     patents characteristics, and patients' management/treatment.   "
172665|NCT00093314|"     The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a     treatment for Chronic Lymphocytic Leukemia.   "
159040|NCT01201967|"     For this trial, the investigators propose a prospective trial of a collaborative care program     to identify and treat depression, generalized anxiety disorder, and panic disorder among     patients admitted to the hospital for an acute cardiac illness (acute coronary syndrome,     congestive heart failure, or arrhythmia). Such assessment and treatment for     depression/generalized anxiety disorder/panic disorder will begin in the hospital, and     ongoing management will continue for six months following discharge.      The investigators hypothesize that this model will lead to increased treatment rates,     improved mood, reduced anxiety, and improved medical outcomes in this vulnerable population.     If this model is effective, it could be implemented clinically to provide better and more     complete care to patients hospitalized with acute cardiac illness, for whom depression and     anxiety may be a risk factor for complications and death.      This will be a two-arm, single-blind randomized controlled trial, with one-half of patients     randomized to collaborative care and one-half randomized to the control condition (usual     care). Psychiatric treatment in the intervention arm will be provided in concert with     patients' primary care physicians—with primary care physicians prescribing all     medications—within a framework supervised by a psychiatrist.      The investigators will enroll patients who have any (or all) of the three included     psychiatric diagnoses to improve the utility of the intervention. The investigators have     chosen to enroll patients with several different cardiac diagnoses. This will allow the     researchers to include patients with heterogeneous diagnoses and illness severity to     determine if our intervention is effective in a broad population of patients with heart     disease. The investigators will study an intervention targeting depression, generalized     anxiety disorder, and panic disorder: all three disorders are disabling and associated with     adverse cardiovascular outcomes, treatments for the conditions are highly similar, the     investigators can treat patients who have more than one disorder, and a prior outpatient     program successfully simultaneously addressed more than one mental health condition.      The project will involve: (1) screening patients for depression, generalized anxiety     disorder, and panic disorder as part of usual clinical care, (2) evaluation of     positive-screen patients by a study social work care manager, (3) a multicomponent     in-hospital intervention (for collaborative care patients) that involves patient education,     specialist-provided treatment recommendations, and a goal of in-hospital treatment     initiation, and (4), after discharge, continued phone-based evaluation and care coordination     with primary care physicians to provide stepwise treatment in the collaborative care arm. The     intervention has been designed to be low-cost, low-burden, and easily generalizable to other     settings.   "
159041|NCT01201954|"     Evaluate the effectiveness of the use of a 24% sucrose solution for pain management of     preterm infants during endotracheal suctioning.   "
159042|NCT01201941|"     The objective of this study is to compare the effects of a web-based laboratory information     system (e-Chasqui) between a network of health establishments with access to e-Chasqui     (intervention group) and a network of health establishments without access to e-Chasqui     (control group).      The specific aims are:        1. To compare the laboratory turn-around-time (from the date a culture or drug          susceptibility test (DST) result is obtained to the date the result is obtained at the          health center) of samples pertaining to health establishments in the intervention versus          the control group.        2. To compare the clinical turn-around-time (from the date the DST result is obtained to          the date the patient is evaluated by a physician in possession of that result) among          multi-drug-resistant tuberculosis (MDR-TB) patients pertaining to health establishments          in the intervention versus control group.        3. To compare the laboratory reporting errors (defined as incorrect smear, culture, or DST          results) between health establishments in the intervention versus control group.        4. To qualitatively assess the acceptability and usability of e-Chasqui among users in          health establishments with access to the system.      The investigators aim to test the following hypotheses:        1. The laboratory turn-around-time for health establishments with e-Chasqui access will be          smaller than that for establishments without e-Chasqui access.        2. The clinical turn-around-time for patients pertaining to health establishments with          e-Chasqui access will be smaller than that for patients in establishments without          e-Chasqui access.        3. Health establishments with e-Chasqui access will have fewer errors compared to those          without e-Chasqui access.        4. Factors associated with acceptability and usability of e-Chasqui by systems users can be          identified.   "
159043|NCT01201928|"     The purpose of this study is to evaluate pulmonary function test (PFT) sub-study in     interested subjects from studies MKC-TI-161, MKC-TI-162 and MKC-TI-166. 100 Type I and 100     Type II diabetics will be enrolled. Each subject will undergo 6 PFT assessments over the     course of the parent study.   "
159044|NCT01201915|"     This was a 3-cohort, open-label study of vismodegib (GDC-0449) in new (non-recurrent)     operable basal cell carcinoma of the nodular subtype.   "
159045|NCT01201902|"     The purpose of this study is to assess the safety and the body's immune response to an     experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will     enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or     vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than     or equal to 65 years of age.   "
159046|NCT01201876|"     The purpose of this study was to document the reasons for replacement or repair of defective     restorations (fillings) and to record the restorative material of the failed restoration     and the material used in the replacement restoration on permanent (adult) teeth.   "
159047|NCT01201863|"     The purpose of this study is to: Address 3 short term objectives; (1) Determine the effects     of physiologic testosterone (T) therapy on neurological function and functional independence     following traumatic brain injury (TBI) in hypogonadal men during inpatient rehabilitation;     (2) Document the natural history of neuroendocrine dysfunction and recovery in men during     inpatient rehabilitation after TBI; (3) Obtain data to validate the NIH toolbox, a novel     assessment of neurological function for use in the TBI population; and two long-term     objectives: (1) Utilize study findings to design a multicenter trial to further assess the     impact of T therapy in hypogonadal men following TBI and (2) Impact TBI practice management     with new information about neuroendocrine dysfunction after TBI and hormone treatments to     improve outcomes.   "
159048|NCT01201850|"     This study is being done to learn about the safety of the study drug bevacizumab(Avastin®),     when used to treat radiation necrosis.      The primary objective of this study is to test the feasibility of treating Central Nervous     System (CNS) tumor patients suffering from radiation necrosis with bevacizumab every 2 weeks.      The secondary objectives of this study are:        -  To evaluate improvement in neurologic symptoms associated with bevacizumab as assessed          by clinical evaluation;        -  To investigate the neuro-imaging changes in radiation necrosis associated edema,          including Mass Resonance (MR) spectroscopy;        -  To evaluate changes in corticosteroid use in patients with radiation necrosis following          treatment with bevacizumab;        -  To evaluate changes in quality of life.   "
159049|NCT01201837|"     Cardiovascular disease remains the most pressing healthcare issue for developed countries and     is becoming so for developing countries. There are a number of chronic therapies available     for long-term management of risk. Short term therapies for subjects with an acute event, such     as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing     thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a     different site. There are no approved therapies that can rapidly reduce the burden of     unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that     could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities     of cholesterol from the vasculature, improvement in endothelial function, protection against     oxidative damage and reduction in inflammation. This study will assess the effects of     CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and     regression as assessed by intravascular ultrasound (IVUS) measurements in patients with     (ACS).   "
159061|NCT01201681|"     The purpose of this study is to identify pre-operative factors that put patients at greater     risk of developing severe tooth pain following root canal therapy, thereby providing evidence     that will allow dentists to act preventively to lessen this risk, improve pain control,     increase their patients' quality of life, and decrease the number of dental emergency     interactions.      A parallel goal of this study is to assess the feasibility of recruiting dentists that     provide root canal therapy and patients using the DPBRN.   "
159050|NCT01201824|"     Pulmonary nodules are one of the most common thoracic radiographic abnormalities. They are     usually found accidentally as discrete well emarginated pulmonary lesions found within the     lung parenchyma during a routine chest x-ray. Pulmonary nodules are usually asymptomatic.     Most solitary lung nodules are benign; however these nodules can represent early stage lung     cancer. The identification of malignant pulmonary nodules is important because they represent     a potential form of curable lung malignancy. Every lung nodule should therefore be     investigated for the possibility of malignancy.      Ultrasound has been beneficial in almost all medical and surgical specialities. The idea of     using ultrasound during VATS has emerged from its use in laparoscopic procedures. Few studies     have investigated the use intracavitary ultrasound for localizing pulmonary nodules. The     sensitivity of ultrasound detecting pulmonary nodules is high (92%). In some studies,     ultrasound could detect all pulmonary nodules detected by high resolution CT. It has also     been shown to be able to locate nodules not visualized on spiral CT.      The use of intracavitary ultrasound has been suggested by many authors as a safe and     effective method for localizing hard to find nodules. It is a real time technique with no     associated complications, low cost, and has the potential to save operative time. Most     importantly, it may be able to prevent conversion of VATS to open operations in cases where     nodules are not visualizable or locatable using VATS techniques.      The use of intracavitary US as a localization method by surgeons intra-operatively could lead     to better identification of nodules. Also, this technique could avoid performing multiple     procedures on patients (CT guided targeting followed by surgery) and therefore is more     cost-efficient. If proven accurate, surgeon-performed intracavitary ultrasound could be used     routinely during VATS procedures, increasing the chances of finding and localizing pulmonary     nodules using minimally invasive techniques.   "
159051|NCT01201811|"     The primary purpose of this study is to determine the effectiveness and safety of azacitidine     in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).   "
159052|NCT01201798|"     The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times     daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of     endogenous anterior uveitis.   "
159053|NCT01201785|"     Since diabetic platelets are characterized by an enhanced turnover rate, it may be     hypothesized that an increase in the frequency, rather than the dose, of drug administration     may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this     may enable COX-1 blockade of newly generated platelets. However, how different dosing     regimens impact the pharmacodynamic effects of aspirin selectively in diabetes mellitus has     been poorly explored. Therefore, the aim of the present pilot investigation was to evaluate     how increasing the frequency of aspirin administration, remaining within the daily     recommended therapeutic doses, affects antiplatelet responsiveness in diabetic patients with     coronary artery disease.   "
159054|NCT01201772|"     A higher degree of platelet inhibition remains the goal of peri-interventional and long-term     anti-thrombotic therapy in patients with coronary artery disease. In clinical practice,     patients undergoing percutaneous coronary intervention with stent implantation who are     already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior     observations showing that higher inhibition of platelet aggregation may be achieved by giving     a loading dose of clopidogrel in patients with coronary artery disease while on chronic     clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet     aggregation can be achieved by adding a prasugrel loading dose in patients on chronic     prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel     re-load strategy in patients on already on chronic prasugrel therapy will be useful.   "
159055|NCT01201759|"     The overall study objectives are to examine whether:        1. Persons with spinal cord injury (SCI) having elevated body mass are at greater          cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and          vascular inflammation than persons with SCI having 'normal' body mass, and        2. An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks          associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.   "
159056|NCT01201746|"     Currently the research issue in establishing the role of periodontal disease (PD) in coronary     heart disease (CHD) risk is to define the pathways that lead to cause-effect relationship     between PD and CHD. There is no consensus on definition of a periodontal disease case or the     threshold level that may give clear indication for this relationship. Periodontal therapy has     been used in different studies with the hope that a change in periodontal disease status may     modify the factors associated with CHD risk. Many of these studies, on role of periodontal     therapy in the reduction of CHD associated risk-factors, were based on small study samples,     and very few studies were randomized controlled trials. So a need for large prospective     studies is warranted in literature.----------- A single-blind parallel-arm randomized     controlled clinical trial was designed to observe the influence of periodontal treatment on     serum inflammatory mediators of hsC-reactive protein, white blood cells and fibrinogen in CHD     patients.      Hypothesis: Periodontal therapy in CHD patients, by reducing periodontal inflammation, may     decrease the host systemic inflammatory burden associated with atherogenic processes.   "
159057|NCT01201733|"     The purpose of this study is to evaluate the immediate effect of traditional Thai massage on     brain electrical activity in the patients with scapulocostal syndrome   "
159058|NCT01201720|"     The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on     albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic     patients with acute-on-chronic liver failure.   "
159081|NCT01201421|"     The purpose of this study was to administer two questionnaires. The first, a Dental     Satisfaction Questionnaire to assess patient satisfaction with a restoration visit using     patients recruited from practices participating in the Dental PBRN Reasons for replacement     or repair of dental restorations study. The second questionnaire (completed by the     practitioner) was a brief single page questionnaire to evaluate the patient visit.   "
159059|NCT01201707|"     The study is being done to determine if venous angioplasty is an effective treatment for     chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or     blockages are present in the internal jugular or azygos veins (veins which drain blood from     the central nervous system) and these blockages may be associated with symptoms classically     attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with     CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the     effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two     groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty     and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in     this study, and the neurologist evaluating patients after the procedure, will not know     whether or not they were treated with angioplasty.   "
159060|NCT01201694|"     The goal of this clinical research study is to find the highest tolerable doses of     surface-controlled water dispersible curcumin (curcumin) that can be given to patients with     advanced cancer. The safety of this drug will also be studied.   "
159063|NCT01201655|"     The purpose of this study is to investigate the impact of splenectomy coupled with     portal-azygous disconnection on hepatocarcinogenesis in patients with post-hepatitic     cirrhosis after hepatitis B or C virus infection by retrospective case-control study,We hope     to find a new idear and method to prevent or cure HCC.   "
159064|NCT01201642|"     The aim of this study is to compare the effects of prednisolone and staging acupuncture in     the recovery of the affected facial nerve, and to verify that whether in combination with     staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large     number of patients.   "
159065|NCT01201629|"     Overall goal of this study is to determine if transcranial direct current stimulation (tDCS)     plus conventional occupational therapy improves functional motor recovery in the affected     arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional     occupational therapy, and to obtain information to plan a large randomized controlled trial.   "
159066|NCT01201616|"     A previous study has found that the consumption of a high fat, low carbohydrate meal results     in increased feelings of calmness, friendliness and an increase in subjective energy levels     in comparison to a low fat, high carbohydrate meal. The purpose of this study is to     investigate whether a high fat, low carbohydrate diet for a longer duration (of 2 weeks) can     enhance or sustain these changes in comparison to a low fat, high carbohydrate meal.   "
159067|NCT01201603|"     The aim of this study is primarily to investigate the ability of antioxidants found in orange     juice (OJ) to increase the body's sensitivity to the hormone insulin. Overweight or mildly     obese women, who are otherwise healthy, will be recruited. The time commitment for subjects     is ~14wks. Subjects will attend the laboratory on 5 occasions after fasting from midnight.     The 1st is a medical screening. Laboratory visits 2 & 5 will take ~5hrs and will be separated     by 3 months, during which time subjects will consume 250ml of an orange drink (either OJ or     an orange flavoured control drink) once a day. During visits 2 & 5, subjects will have a scan     to assess their %body fat using a low-dose x-ray machine, and have their insulin sensitivity     measured using a technique called a 'Glucose Clamp'. During the 3hr glucose clamp, subjects     receive an infusion of the hormone insulin and a glucose solution directly into their blood     stream, with insulin sensitivity determined from the amount of glucose required to maintain     blood glucose at normal levels. In addition, a small sample of fat tissue (about the size of     a haricot bean) will be taken from underneath the skin of the belly. Subjects will record     their food intake for 3-days in weeks 3, 7 and 11 of consuming the drink, and come to the lab     for visits 3&4 during weeks 4&8. Laboratory visits 3&4 repeat measurements taken in the 1st     (screening) visit.   "
159068|NCT01201590|"     The aim of the current study is to investigate the ability of antioxidants found in cocoa     ('flavanols') to increase the body's sensitivity to the hormone insulin. 32 overweight or     mildly obese women, who are otherwise healthy, will be recruited. Subjects will attend the     laboratory on 3 occasions after fasting from midnight. The 1st visit is a medical screening,     with laboratory visits 2 and 3 separated by 4 weeks, during which time subjects will consume     a cocoa drink (containing either high or low amounts of flavanols) twice a day. Subjects will     record their food intake for 3-days before visit 2 and in week 3 of consuming the cocoa. They     will also eat a diet of standard macronutrient composition for 3 days before visits 2 and 3.     During the 5 hour laboratory visits, subjects will have a scan to assess their body     composition using a low-dose x-ray machine (Dual Energy X-ray Absorptiometry; DEXA), and have     their insulin sensitivity measured using a 3 hour hyperinsulinemic, euglycaemic Clamp.   "
159080|NCT01201434|"     Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic     treatment. These factors taken together with high sputum viscosity and slow motility of the     gastrointestinal tract-may change the pathogenicity and consistency of the intestinal     pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A     pilot study performed by the researchers using probiotics in CF patients showed a decrease in     the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled     trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum     inflammatory markers in CF patients.   "
159082|NCT01201408|"     The purpose of this study is to assess the quality and expected lifespan of fillings recorded     in the DPBRN Reasons for placing the first restoration on permanent tooth surfaces study,     and the factors affecting how long the fillings last.   "
159069|NCT01201577|"     It has recently been discovered that bacteria are able to communicate using specialised     molecules known as Quorum Sensing Signalling Molecules (QSSMs). An accumulation of QSSMs in     their surrounding environment allow for the bacteria to quantify the size of colonies. At     specific colony sizes the concentration of QSSMs reaches a critical threshold leading to the     activation of genes that cause an infection. It is by this mechanism that bacteria within a     colony coordinate behaviour to activate infectivity when colony sizes are large enough to     withstand defensive measures from the host's immune system. A disruption of quorum sensing     may reduce the severity of infection and this has led to the development of inhibitors of     quorum sensing as a new strategy in antibacterial therapy.      QSSMs are also thought to facilitate infection by other mechanisms and are able to influence     the number and function of a specific type of immune cell known as an 'antigen presenting     cell'. These cells are pivotal in allowing the immune system to recognise components of     bacteria as foreign and thereby mount the appropriate response. It was found that large     numbers of these types of cells underwent programmed cell death (cell suicide) in the     presence of QSSMs compared to when QSSMs were absent. This mirrors the situation in blood     sampled from patients with severe infections where there is a greater proportion of cell     deaths among antigen presenting cells than other types of immune cell.      This study aims to establish in healthy volunteers, the mechanisms by which QSSMs affect     immune cells and facilitate the spread of infection. Antibiotic administration in humans can     alter the environment of the intestine and can lead to an overgrowth of harmful bacteria to     potentially cause an infection. Probiotics supplements can prevent bacterial overgrowth and     potentially reduce infective complications. The mechanism, which we aim to clarify, may     involve changes in both the production of QSSMs and the function of immune cells.      Hypothesis        1. Antibiotic use alters gut flora, leading to the appearance in the systemic circulation          of bacterial QSSMs and changes in immune function of the host.        2. Probiotics and/or prebiotics have beneficial effects by preserving the normal resident          gut flora, thereby, modulating bacterial QSSMs and preserving the immune function of the          host.      Aims      The aims of our study are 2 fold:        1. Firstly, to study the effect of orally administered antibiotic on QSSMs (in faeces and          blood) and on innate and adaptive immunity in healthy humans.        2. Secondly, to study the effect of orally administered combinations of prebiotic,          probiotic and antibiotic on QSSMs (in faeces and blood) and on innate and adaptive          immunity in healthy humans.   "
159070|NCT01201564|"     This study is designed to compare two techniques for operative care of umbilical hernia in     adults regarding wound complications, wound side fluid collections, recurrence rate,     postoperative pain, duration of hospitalization and quality of life. The IPOM technique     provides mesh positioning directly into the abdominal cavity onto the defect under     laparoscopic control while in sublay position the mesh is placed directly behind the rectus     muscle after small incision close to the belly button.   "
159104|NCT01201122|"     The purpose of this study is to evaluate effectiveness of once daily dosing of Pentasa     compared with twice daily in children with mild to moderate active ulcerative colitis.   "
159071|NCT01201551|"     It is already known that the local treatment with Alphagan eye drops (a drug commonly used by     glaucoma patients) reduces ocular blood flow. In-vitro studies suggest that the     vasoconstrictive effect of Alphagan is more pronounced when this drug is combined with a     prostaglandin analogue (eg. Xalatan eye drops). The investigators also question whether this     effect is more pronounced in subjects suffering from a primary vascular dysregulation (PVD).     To test for the effect of these drugs on PVD and non-PVD subjects the investigators will take     measurements of corneal temperature as surrogate for ocular blood flow.   "
159072|NCT01201538|"     Acoustic Neuromas (otherwise known as Vestibular Schwannoma -VS) are benign tumors which grow     on the hearing nerve and can cause progressive hearing loss and compression of vital brain     structures and even death if it continues. The primary objective of this study is to evaluate     the efficacy of Nilotinib in the treatment of patients with progressing VS. Secondary     objectives of this study is to evaluate the toxicity profile, quality of life and symptom     management of Nilotinib in the treatment of patients with progressing VS.   "
159073|NCT01201525|"     Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser     treatments.      Study design: Prospective single blinded within patient controlled randomised trial. Recent     surgical scars of at least 5cm will be divided into 2 parts and randomized. 1 part will be     treated with 4 595nm Pulsed dye laser treatments on a 4 weeks interval. The other part will     serve as a within patient control. 1 and 6 months after the intervention both parts of the     scar will be evaluated.   "
159074|NCT01201512|"     The purpose of study was to characterize using an online questionnaire the feasibility of     recruiting dentists in primary care dental practices in the practice-based research network     and documenting their current initial care for their TMJD pain patients.   "
159075|NCT01201499|"     Inadequate pain control after abdominal procedures may lead to adverse postoperative outcome.     Epidural analgesia is currently an accepted technique in abdominal surgery, but its use has     been limited in liver resections by postoperative coagulation disturbances and the possible     increased risk of bleeding complications, including spinal hematoma. A range of alternative     analgesic techniques can be used for major liver or pancreatic resections, including     intrathecal morphine (single shot) administered immediately before surgery, and continuous     administration of intravenous (IV) short-acting opioids, such as remifentanil, plus a single     bolus of IV morphine. Postoperatively analgesia may be obtained by patient-controlled     morphine analgesia (IV PCA). Both protocols have been demonstrated to provide satisfactory     postoperative pain relief, and each has its unique advantages. However, to this end there is     no data in the literature to show benefit from one regimen over the other. We therefore wish     to determine whether there is a difference in analgesic efficacy between the two techniques,     as optimizing perioperative pain relief in this rapidly expanding surgical field is of utmost     importance. Our hypothesis is that continuous intraoperative IV analgesia with remifentanil     followed by IV PCA morphine is not inferior to intrathecal morphine with respect to analgesia     and ambulation outcome, and may provide an alternative, non-invasive intraoperative analgesic     technique.   "
159076|NCT01201486|"     To evaluate the percentage of severe heart defect diagnosed with the use of color Doppler at     a routine fetal scan in the second trimester of pregnancy   "
159077|NCT01201473|"     The purpose of this study was to study the use of a Core Questionnaire that included several     questions from each PBRN (DPBRN, PEARL, PRECEDENT - collectively know as CONDOR) that had     been extracted from questionnaires previously administered as part of their initial research     program activities. This protocol was the first administration of this core questionnaire     with the purpose of assessing dental practice changes that may have occured since the earlier     administration of the individual questions with the separate networks.It also collected     baseline data for others.   "
159078|NCT01201460|"     The principal goal of this study was to assess the feasibility of plasma glucose testing in     private dental practice. A second aim was was to assess prevalence of plasma glucose     abnormalities in dental patients seen by (DPBRN) practitioner-investigators.   "
159079|NCT01201447|"     The purpose of this study was to investigate the process involved when making decisions about     the diagnosis and treatment of questionable lesions, as well as determine if there is any     association between lesions progression (or depth, if opened) and clinical characteristics     and baseline risk assessment.   "
160215|NCT01186458|"     The purpose of this study is to determine the effectiveness of fludarabine, Velcade, and     rituximab treatment regimen in patients with relapsed or refractory follicular non-Hodgkin     lymphoma.   "
159084|NCT01201382|"     This study is a randomized controlled trial comparing Interpersonal Psychotherapy-Adolescent     Skills Training (IPT-AST) to group counseling (GC) for the prevention of depression in     adolescents. The project will: (1) identify adolescents with elevated depressive symptoms but     who do not meet criteria for a current mood disorder diagnosis; (2) randomize eligible     adolescents to either IPT-AST (N = 100) or GC (N = 100); (3) assess depressive symptoms,     depressive disorders, global functioning, interpersonal functioning, comorbid conditions and     school related indices at baseline, mid-intervention, post-intervention, and at 6-, 12-, 18-,     and 24-month follow-up; (4) examine the effects of IPT-AST on depression and various domains     of functioning at each time point; and (5) conduct analyses to examine potential mediators     and moderators of the association between IPT-AST and depression outcomes. This study will     yield data on the efficacy of IPT-AST relative to GC for the prevention of depressive     symptoms and depressive disorders. It will also provide information about the mechanisms of     action of IPT-AST and determine for whom IPT-AST is most effective.   "
159105|NCT01201109|"     The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel     release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after     surgery.   "
159106|NCT01201096|"     The purpose of this study is to show the tumor free long term survival of patients with     isolated non-resectable liver metastases of neuroendocrine tumors after neo-adjuvant radio     receptor treatment and following liver transplantation.   "
159151|NCT01200511|"     The purpose of this study is to describe visual outcomes, in particular spherical equivalent     by manifest refraction and visual acuity across a range of distances, 6 months post     implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with     corneal astigmatism. Additionally, patient reported outcomes will be assessed.   "
159085|NCT01201369|"     Despite recent advances in stent technology and clot reducing drug therapy, acute stent     occlusion or thrombosis (ST), still occurs and can be life threatening. It has been shown     that certain features of how the stent relates to the artery wall may predict ST. One such     feature, so-called stent strut malapposition (SSM), can be assessed after implantation but     current imaging techniques are relatively unreliable. Optical Coherence Tomography (OCT) is a     newer technology that can be performed safely and easily after angioplasty and may allow the     stent struts to be assessed more accurately and reliably.      This study will use OCT to examine how two different types of commonly used drug-eluting     stents relate to the artery wall. The Xience V (Abbott Vascular, USA) stent has thinner     struts and a more open frame than the Cypher (Cordis, USA) stent. We hypothesise therefore     that the potentially more pliable structure of the Xience V stent will be associated with     greater contact with the vessel wall. This may have a bearing on the relative rate of SSM,     although large studies have shown the rate to be low in both the Cypher and the Xience V     stent. We believe that OCT imaging of SSM and symmetry of the stent immediately after     angioplasty will compliment conventional visual assessment and may identify those patients in     whom further improvement of stent with a balloon is necessary.      This study will involve the random allocation of forty patients requiring coronary     angioplasty to one of the Cypher or Xience V stent. The procedure will be performed in the     usual manner as indicated clinically and will include imaging of the stented artery segment     with OCT once the operator is satisfied with the visual result by angiography.   "
159086|NCT01201356|"     The purpose of this study is to collect long-term safety and tolerability, long-term     efficacy, and health outcome data in all patients currently ongoing in the fingolimod     multiple sclerosis clinical development program. This study will combine all currently     ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned     studies into one single long-term extension protocol that will provide patients with     continuous treatment and will continue until fingolimod is registered, commercially     available, and reimbursed in the respective countries.   "
159087|NCT01201343|"     This study is planned to evaluate emotional disorders during treatment by interferon (IFN)     beta in relapsing remitting multiple sclerosis (RRMS) subjects. This is an open-label     exploratory study with no change of therapeutic behavior but with standardized     neuropsychologic follow-up.   "
159088|NCT01201330|"     The purpose of this study was to determine the prevalence of ONJ in the patient population of     2 large HMOs and study the risk factors associated with the development of this condition.   "
159089|NCT01201317|"     A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days     treatment in patients with painful diabetic polyneuropathy.   "
159090|NCT01201304|"     This study compares the relative efficacy of three methods of delivering interoceptive     exposure for the reduction of elevated anxiety sensitivity. The interventions vary according     to their intensity and use of coping strategies during exposure. An expressive writing     intervention serves as an expectancy control.   "
159091|NCT01201291|"     Aim of the study is to investigate the impact of two different fractions of inspired oxygen     (FiO2) on outcome in patients with severe traumatic brain injury (TBI).   "
159092|NCT01201278|"     This study is designed to compare the safety and tolerability of two different doses of     intranasally administered regular human insulin with those of a single dose of the     rapid-acting insulin analog lispro Humalog® after subcutaneous injection. In addition to     safety and tolerability, various pharmacokinetic (PK) and pharmacodynamic (PD) parameters     will be evaluated by means of the euglycemic glucose clamp technique.   "
159093|NCT01201265|"     This multicenter study will assess the efficacy and safety of bevacizumab in combination with     gemcitabine and cisplatin as first line treatment in participants with triple negative     metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg     intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an     area under curve [AUC]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study     treatment is until disease progression.   "
159094|NCT01201252|"     The purpose of this study is to estimate the disease burden and epidemiology of rotavirus     gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute     gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book     and stool samples will be collected from all suspected and confirmed acute gastroenteritis     cases.   "
159095|NCT01201239|"     To assess the safety, tolerability and efficacy of Raltegravir (RAL) when combined with other     antiretroviral drugs in treatment-experienced Chinese HIV-infected patients, including those     with multi-drug resistant HIV-1 infection or drug intolerance.   "
159096|NCT01201226|"     The purpose of this study to obtain ovarian cortical fragments from perimenopausal patients,     who undergo pelvic organ surgery and test whether treatment with PTEN inhibitor and PI3K     activating peptide would induce these fragments to produce FSH responsive follicles in the     nude mouse model.   "
159097|NCT01201213|"     A need exists to define the best local anesthetic and technique for pain relief in early     labour. We suggest that calculating the molar Median Effective Dose for bupivacaine,     levobupivacaine and ropivacaine given both by the intrathecal (as a combined spinal epidural     and epidural routes) would provide a valid comparison between the pain relieving properties     of all three drugs, from which a reasoned assessment of side effects can be made.   "
159101|NCT01201161|"     The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative     vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving     its anatomical and functional results in patients with advanced proliferative diabetic     retinopathy and traction retinal detachment.   "
159102|NCT01201148|"     This study will investigate whether using oscillating TES (random noise stimulation) or     intermittent tDCS will have greater antidepressant effects in depressed subjects, compared to     standard tDCS.   "
159103|NCT01201135|"     Patients with thalassemia intermedia, congenital dyserythropoietic anemia type I , and     sideroblastic anemia were found to express very high levels of serum GDF15, and this     contributed to the inappropriate suppression of hepcidin with subsequent secondary iron     overload.The aim of our present study is to asses the levels of GDF15 and hepcidin in     patients with Sickle cell disease and hereditary spherocytosis   "
159107|NCT01201083|"     Specific Aim 1: Identify drug use patterns and partnership dynamics that mediate risk     behaviors over time in a cohort of recently HIV infected men and their partners.      Specific Aim 2: Determine predictors of transmission risk within partnerships of recently HIV     infected men and their partners, using the partnership as the unit of analysis.      Specific Aim 3: Quantify the long-term population-level impacts of voluntary behavior change     by men with recent HIV infection, through the use of dynamic mathematical modeling that     integrates our data on behavior change with current estimates of temporal infectiousness     patterns. The investigators will also determine whether more frequent testing and/or     development of tests with earlier sensitivity may have a significant impact on the epidemic.     Finally, the magnitude of this effect to that obtained by decreasing drug use or risky sexual     behavior prior to or following seroconversion will be compared. This will be conducted as a     statistical analysis by co-investigators at the University of Washington.   "
159108|NCT01201070|"     General and specific objectives of the search: evaluate the effects of the administration of     Antithrombin III (ATIII) on the activation of the coagulation system and of the fibrinolysis,     platelet function, inflammatory response and markers of organ damage in patients undergoing     cardiac surgery by cardiopulmonary bypass (CPB) with low plasma levels of post-operative     Antithrombin (AT).   "
159109|NCT01201057|"     The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of     bacterial vaginosis.   "
159110|NCT01201044|"     The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced     NSCLC.   "
159111|NCT01201031|"     Vancomycin -resistant enterococci(VRE) has emerged as one of the most common nosocomial     pathogen of health-care associated infection since 1988. Although the new antimicrobial     agents such as Tigecycline , Daptomycin, Linezolid have clinically effectiveness for the     treatment of VRE, but there was not appropriate drugs for eradicating the colonization of     VRE. So the active surveillance and strict contact precaution are the best methods for VRE     colonization and transmission.      This is a one year study program, we select a unit as the study site. First month (January)     is the prepare period. Therefore , we collect 3 months (from February to April) baseline     data, then interrupted one month(May) for the health care worker's infection control     education.      Then the intervention period are three months (from June to August), and the last four     months(from September to December) are the analysis and evaluation period. In the baseline     period, we only do the patient's active surveillance and environmental culture. In the     intervention period, beside the patient's active surveillance and environmental culture, we     add contact precaution as the infection control method. If patient has VRE infection, we     prescribe appropriate antibiotic therapy until the culture result proved no growth of VRE.      The aim of this study is to compare and analyze these two period (baseline period and     intervention period) for understanding the transmission, risk factors and carriage rate of     VRE, as the important guidelines for the VRE infection control in the future.   "
159112|NCT01201018|"     The study will be non randomized, open label, dose rising study in cancer patients. Cancer     treatment is consisting of 2 different drugs: Oshadi D and Oshadi R that will be administered     orally.      The study will include two sessions:        -  A single dose period to evaluate acute toxicity of each drug        -  Consecutive multiple increment dose escalation period of both drugs to determine the          long-term safety, and the anticancer activity.   "
159113|NCT01201005|"     Premature birth and low birth weight implies insufficient intrauterine growth and fetal     malnutrition. During the first months of life where the infant is breastfed, the low stores     aquired during fetal life, may cause specific B vitamin deficiencies. In this study infants     with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. At 6 months     infants with biochemical signs of impaired cobalamin status (i.e.: tHcy > 97.5 percentile for     cobalamin treated infants, i.e.: tHcy>6.5 µM/L) will be randomised to cobalamin treatment or     placebo. At 7 months the investigators will evaluate the effect of cobalamin or placebo     treatment according to infant biochemical status and neurodevelopment.      Study hypothesis: Cobalamin treatment given to infants with biochemical cobalamin deficiency     will normalize biochemical status and cause improved motor neurodevelopment.   "
159139|NCT01200667|"     The application scenario is shown in the figure below: the user utilizes an ECG-based     wireless sensor (WiBoC Chipset), and transmit those signals to a mobile-phone device that has     an embedded expert system integrated. With the aid of 3G system, a remote healthcare     monitoring center receives those uploaded signals and stores into the application server.     According to the events from this server, the people on service responses to the emergency     and takes the corresponding process.   "
159935|NCT01190111|"     This study was designed to evaluate the pharmacokinetics of 20µg/kg/week of Interleukin-7     (CYT107), the biological activity and safety of repeated cycles of CYT107, for a maximum of 4     cycles within 21 months and a maximum of 3 cycles within 12 months.   "
159114|NCT01200992|"     This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be     conducted in approximately 120 investigational sites worldwide. Subjects with either     recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will be eligible for     participation in this study.      Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1,     and/or CIS) at least 6 months from the start of a full induction course of BCG with or     without maintenance/re-treatment at 3 months.      Recurrent disease is defined as reappearance of disease after achieving a tumor-free status     by 6 months following a full induction course of BCG with or without maintenance/re-treatment     at 3 months. Subjects with recurrent disease must have recurred within 18 months following     the last dose of BCG.      Approximately 450 subjects will be randomized. The primary objective of this study is to     evaluate the efficacy of intravesical EN3348 as compared with mitomycin C in the treatment of     subjects with recurrent or refractory NMIBC. The secondary objective is to evaluate the     safety of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent     or refractory NMIBC. This study will consist of 4 phases: Screening, Induction, Maintenance     and Follow-Up and will be conducted over 3 years.   "
159152|NCT01200498|"     The goal of this clinical research study is to learn if SB939 can help to control     myelofibrosis. The safety of this drug will also be studied.   "
159153|NCT01200485|"     The goal of this clinical research study is to learn if using Elitek (rasburicase) for 2     cycles can help to control or prevent TLS better than 1 cycle of rasburicase and 1 cycle of     allopurinol. The safety of this treatment will also be studied.   "
159115|NCT01200979|"     Traditionally, it has been suggested that pregnancy causes an immunosuppressive state that     would facilitate fetal tolerance and result in an increased susceptibility to infection.     Although the suppression has been characterized as a global T-cell defect, the observation     that the increase in susceptibility is restricted only to specific intracellular bacteria and     viruses is consistent with a down regulation of only certain components of the innate immune     system. Progress in the treatment and management of infections during pregnancy will require     further understanding of the changes to the immune system that occur during pregnancy. It is     hypothesized that there is a fundamental down-regulation in the innate immune system that     occurs during pregnancy and remains until delivery and that changes in serum cytokines     influence na(SqrRoot) ve CD4 differentiation to different subpopulations. To that end, this     study will evaluate blood samples drawn from pregnant women during early, mid, and late     pregnancy and post-partum for changes in the innate immune system and compare them to those     of healthy, non-pregnant women. Changes in the cytokine profile and in the lymphocyte and     natural killer (NK) cell populations will be identified. A comparison of any observed changes     will be made with those previously reported for in vitro and in vivo studies....   "
159116|NCT01200966|"     Background:      - Essential tremor (ET) is a neurological disorder involving uncontrollable shaking, which     over time can interfere with mobility and affect routine aspects of daily living. Several     medications are used to treat ET, but these medications are often only partially effective     and can have side effects. About two-thirds (66%) of people with ET have some relief from     drinking alcohol, which suggests that alcohol affects the part of the brain causing the     tremor. However, more research is needed to better understand the effects of alcohol or what     areas of the brain might be important in the response.      Objectives:        -  To study to what extent alcohol is reducing tremor in a group of patients with essential          tremor.        -  To use transcranial magnetic stimulation to study the effects of alcohol on essential          tremor.      Eligibility:      - Individuals who are at least 21 years of age, have been diagnosed with essential tremor and     have tremor in both hands, and can tolerate being off all medications for essential tremor     for up to 4 weeks.      Design:        -  This study has one screening visit (1 to 2 hours), followed by one study visit (3 to 5          hours). Participants might be asked to also take part in one additional study visit (3          to 5 hours). The maximum period between the study visits is 3 months.        -  Participants will be screened with a medical history, physical examination, and blood          tests. At this visit, participants will receive information about how to safely taper          off their current ET medications before the start of the study.        -  Participants must be willing to abstain from drinking any alcohol or caffeine (or          consuming foods with caffeine such as chocolate) for at least 2 days before the study          visits. Participants must also fast overnight (for at least 8 hours) before the study          visits.        -  At the first study visit, participants will receive a single drink of alcohol (mixed          with a noncaffeinated drink) and will complete movement tests to determine whether the          alcohol improves the tremor. Alcohol levels will be monitored throughout the visit.        -  At the second study visit, participants will have an electrocardiogram to measure heart          electrical activity and determine if they are able to safely have transcranial magnetic          stimulation. Participants will then receive an intravenous infusion of alcohol and          complete questionnaires during the infusion to provide information about its effects.          Then, transcranial magnetic stimulation will be used to study brain electrical activity,          as well as muscle movements and tremor activity, while under the influence of the          alcohol infusion.        -  After each study visit, participants will remain at the clinical center until the          effects of the alcohol have worn off. Participants will be able to resume taking their          ET medications after the end of the study.   "
159117|NCT01200953|"     Background:      - Increased clinical attention has been paid to the evaluation and management of     bioterrorism-related illness (such as anthrax infection) and emerging infectious diseases     (such as Severe Acute Respiratory Syndrome [SARS] and new strains of influenza). However,     evaluation and treatment data for these illnesses are often limited because human infections     to date have been relatively limited. Further knowledge about diseases of bioterrorism     concern and emerging infectious diseases may lead to more effective forms of therapy to     prevent disease-related illnesses and deaths.      Objectives:      - To apply standardized, documented, and carefully monitored evaluation and treatment methods     for bioterrorism- and biodefense-related illnesses and emerging infectious diseases at the     National Institutes of Health Clinical Center.      Eligibility:        -  Individuals at least 2 years of age who have confirmed or suspected infection by a          biodefense or bioterrorism agent, or an emerging infectious disease agent.        -  Individuals at least 2 years of age who have confirmed or suspected exposure to a          biodefense or bioterrorism agent, an emerging infectious disease agent, or who have          close exposure to an individual who is suspected of being infected with one of these          agents.        -  Health care workers who are involved in medical treatment of the abovementioned infected          or exposed individuals.      Design:        -  All eligible persons will have an initial screening evaluation to determine the          circumstances of possible infectious exposure (e.g., where, when, and how exposed),          current medical condition and medical care given, and any aspects of medical history          that might be relevant to the exposure.        -  Participants may be seen in an outpatient clinic or in the Special Clinical Studies Unit          (SCSU) at the National Institutes of Health (NIH). The NIH SCSU is a hospital ward          specially designed to minimize the risk of spreading infection to others.        -  Upon admission, participants will provide blood and urine samples, have an          electrocardiogram to measure heart activity, and have specific tests or procedures          associated with the particular infectious agent.        -  Participants who develop illnesses will be treated with the standard of care for known          diseases or with experimental measures, depending on the nature of the illness. Separate          consent may be required for these treatments.        -  Participants will remain on this study for at least 1 year following the period of          active evaluation and treatment. Participants may be asked to come to the NIH outpatient          clinic on a periodic basis for medical evaluations and blood tests, and may be asked to          keep a diary card to record any unusual signs or symptoms of possible infection.   "
159118|NCT01200940|"     Background:      - Artificial sweeteners, such as sucralose (brand name Splenda), are very commonly found in     products such as diet soft drinks. Recently, researchers learned that these sweeteners may     affect hormones in the body, especially when they are consumed in combination with real     sugar. Changes in hormone levels may, in turn, result in changes in blood sugar, appetite,     and weight. Researchers are interested in studying the effects of artificial sweeteners on     the metabolism and hormonal levels of healthy volunteers.      Objectives:        -  To study the effects that artificial sweeteners have on hormone levels, blood sugar, and          appetite.        -  To evaluate whether artificial sweeteners change the rate at which food passes out of          the stomach into the gut, or the rate at which the body absorbs sugar from the gut.        -  To evaluate the effects that different amounts of artificial sweeteners have on hormone          levels.      Eligibility:      - Healthy volunteers between 18 and 45 years of age.      Design:        -  This study will require one screening visit and four testing visits, scheduled on          different days.        -  At the screening visit, eligible participants will be screened with a physical          examination, medical history, blood samples, and body measurements (including height,          weight, body circumferences, and skin folds). Participants will also be asked about how          much artificial sweetener they typically consume and will have taste tests, in which a          small amount of flavored liquid is placed on the tongue and participants will name the          flavor and rate its intensity.        -  Participants will have four glucose tolerance tests on four different days. In          preparation for the test, participants will not eat or drink anything but water for 12          hours prior to the test. Blood will be drawn before the test, and participants will          drink one of the following study liquids, selected at random:        -  Plain water        -  Water mixed with sucralose (the amount found in one 12 oz diet soft drink)        -  Water mixed with sucralose (the amount found in 2.5 12 oz diet soft drinks)        -  Water mixed with sucralose (the amount found in 3.7 12 oz diet soft drinks)        -  Ten minutes after drinking the study liquid, participants will have a sugary drink that          will allow researchers to measure sugar absorption and the speed with which food leaves          the stomach.        -  In addition, participants will complete questionnaires about hunger levels before          drinking the sugar solution and at regular intervals for 2 hours afterward. Blood          samples will be taken at regular intervals as well.   "
159119|NCT01200927|"     The overall goal of this research is to understand the mechanisms underlying the development     of postural control in sitting using new methodology, in order to provide a scientific basis     for evaluation and treatment of posture and movement disorders in infants with cerebral     palsy. The development of early posture control remains poorly understood despite     considerable therapeutic effort. Infants with cerebral palsy show their first delays in the     acquisition of sitting, with subsequent problems developing adequate posture and movement     control. Identifying the delay, determining the nature of the problem, and evaluating the     effectiveness of treatment quickly, are vital in the early part of an infant's life, since     this is the time of greatest plasticity. Tools from nonlinear dynamics, which are     increasingly being used to examine other biological rhythms, are used in this study to     analyze postural sway from center of pressure data during the development of sitting postural     control.   "
159165|NCT01200329|"     The goal of this clinical research study is to learn if the combination of gemcitabine,     busulfan, and melphalan, when given before a stem cell transplant, can help to control     refractory Hodgkin's disease. The safety of this study treatment will also be studied.   "
159120|NCT01200914|"     Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two     areas of particular problems are the terminal portion of the cephalic vein near the shoulder     and the central veins in the chest. Although angioplasty is standard of care the treated     narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your     dialysis access functional. Recently there has been introduction of a new technology called a     covered stent graft. Initial studies suggest that placing this device across the area of     narrowing leads to dialysis access staying open longer and needing less angioplasty     treatments.      This study is designed to compare angioplasty (standard of care) versus using a covered stent     graft. The investigators will then look at the dialysis records and future fistulograms to     see if there is decreased flow through the fistula at 3, 6 and 12 months after the initial     procedure.   "
159121|NCT01200901|"     In summary, the investigators propose to integrate fMRI assessments within a clinical trial     of quetiapine XR in patients with melancholic depression in order to test the predictions     that:        1. quetiapine XR treatment will be effective and safe for patients with major depression          with melancholic features        2. successful treatment with quetiapine XR will be associated with normalization of limbic          areas associated with increased salivary cortisol response to a stressful task as well          as normalization on the emotional faces task differences in the melancholic group          compared with healthy volunteers.        3. successful treatment with quetiapine XR will be associated with normalization of the          salivary cortisol response to the stressful math task (i.e. there will be a diminished          post-treatment mean AUC for cortisol secretion after the stress task compared to the          pre-treatment AUC values in the patient group)   "
159122|NCT01200888|"     The objective of the study is to implement a new method of performing chest CT imaging in     young children with cystic fibrosis at Packard Children's Hospital. This technique will be     used to evaluate early lung disease comparing quantitative chest CT air trapping and airway     measurements with lung function measurements in infants, toddlers, and young children with     chronic lung disease.   "
159123|NCT01200875|"     Platelet-Rich Plasma (PRP) has been banned in competitive athletes because some people think     it may enhance athletic performance. However, there is very little published research to     support or undermine this point of view. The purposes of this study are: (1) To assess the     effects of local platelet-rich plasma (PRP) therapy on systemic levels of growth factors with     suspected or known performance-enhancing effects; and (2) To understand whether the effect of     PRP therapy on these growth factors differs between intramuscular and intratendinous PRP     injections.      This research study is looking for 40 people who are receiving platelet-rich plasma therapy     for a tendon or muscle injury. The study involves collecting seven blood samples (2 teaspoons     each) from each patient, before and after the PRP treatment. Blood samples may be donated at     any location of the patient's choosing, and participants will be paid for their time.   "
159124|NCT01200862|"     This study is designed as a 2-part study, with Part 1 being open-label to best determine the     appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo     controlled design. The study aims to assess the safety and tolerability of BGS649, and     determine whether or not BGS649 is able to normalize testosterone levels and improve insulin     sensitivity in obese, hypogonadotropic hypogonadal (OHH) men   "
159125|NCT01200849|"     The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx     container label design to improve Spanish speaking patients' understanding of instructions     for use.   "
159126|NCT01200836|"     Background:      - The drug rosuvastatin (also called Crestor) is used to lower cholesterol levels in people     with elevated cholesterol levels. Recent studies have suggested that rosuvastatin may affect     the immune system and reduce inflammation, but the reason for this effect is unclear.     Researchers are interested in testing the effect of rosuvastatin on the immune systems of     healthy volunteers with good cholesterol levels.      Objectives:      - To evaluate the effect of rosuvastatin on the immune systems of healthy volunteers.      Eligibility:      - Healthy individuals at least 18 years of age who have an acceptable blood level of LDL     cholesterol (below 160).      Design:        -  Participants will be screened with a medical history and physical examination, as well          as blood tests to check general health, cholesterol levels, liver function, and the          C-reactive protein (which responds to inflammation).        -  Participants will not be permitted to take most prescription and over-the-counter          medications that affect the immune system, including antihistamines and certain pain          relievers. For 1 week before the study, participants will have a wash-out period without          any of these medications.        -  Participants will take rosuvastatin daily for 4 weeks, always in the evening (to ensure          consistent blood sample results).        -  Participants will provide blood samples at the following time points: (1) immediately          before the start of the rosuvastatin treatment, (2) after 2 weeks of treatment, (3)          after 4 weeks of treatment, and (4) 2 weeks after the end of treatment.   "
159148|NCT01200550|"     The purpose of this study is to evaluate symptoms control and impact on daily life from     patients perspective using specific GERD Impact Scale(GIS) questionnaire. The another     objective is to obtain local epidemiological data for Bosnia and Herzegovina regarding GERD     treatment in primary care.   "
159539|NCT01195376|"     In this study, BEZ235 will be administered to adult patients with advanced solid tumors whose     disease has progressed despite standard therapy or for whom no standard therapy exists. The     trial will confirmed the safety and tolerability and determine the MTD of BEZ235 in Japanese     patients.   "
159140|NCT01200654|"     Linezolid is the first of a new class of antibacterial drugs, the oxazolidinones. It has a     specific inhibitory activity against Gram positive bacteria, including methicillin-resistant     Staphylococcus aureus (MRSA).      Dosage of 600 mg discontinuous administration twice a day was about studies in safety     volunteers. The intensive care units patients, with mechanical ventilation, and with severe     sepsis, represent highly heterogeneous population responsible of hight variability in     pharmacokinetics parameters (augmentation in total volume of distribution, modification in     glomerular filtration) wich can lead to antibiotic inefficacy.      In a first time, this study describe the pharmacokinetics of Linezolid in intensive care     units patients with severe MRSA infection. The aim of this study is to define and validate a     population pharmacokinetic model including the influence of patients' characteristic on the     pharmacokinetics of Linezolid.   "
159127|NCT01200823|"     Background:      - The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) is     conducting a variety of laboratory research experiments that require blood, bone marrow,     urine, stool, and/or tissue samples from patients with a diagnosis of an immunologic,     autoimmune, or inflammatory disorder, as well as from their healthy relatives. Donated     samples will be sent to the CHI laboratory at the National Institutes of Health to be used in     research that may provide more information on the changes in the immune system caused by     these specific disorders.      Objectives:      - To collect blood, leukapheresis cells, bone marrow, urine, stool, cheek swab, and tissue     samples from patients with immune-mediated and inflammatory diseases, as well as from family     members, for ongoing exploratory research studies.      Eligibility:        -  Individuals at least 2 years of age who have been diagnosed with an immune-mediated or          inflammatory disease, or have signs or symptoms of an immune or inflammatory disease          without a formal diagnosis.        -  Immediate family members (parent, child, sibling, grandchild) of the above mentioned          individuals.      Design:        -  Participants will be screened with a complete medical history, physical examination, and          blood and urine samples.        -  Participants will provide blood, urine, stool, cheek swab, and tissue samples as          required by the study researchers.        -  Participants who have immune or inflammatory diseases will also provide blood and bone          marrow samples collected through biopsies and leukapheresis (to collect specific blood          cells).        -  Adult relatives will provide additional samples through more invasive procedures such as          leukapheresis and bone marrow biopsies. Child relatives (between 2 and 18 years of age)          will not undergo these invasive procedures.        -  No treatment will be provided as part of this protocol.   "
159128|NCT01200810|"     This partially randomized phase II trial is studying how well giving bicalutamide together     with RO4929097 works in treating patients with previously treated prostate cancer. Androgens     can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may     lessen the amount of androgens made by the body. RO4929097 may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Giving bicalutamide together with     RO4929097 may be an effective treatment for prostate cancer   "
159129|NCT01200797|"     This phase II trial is studying how well SJG-126 works in treating patients with epithelial     ovarian, primary peritoneal, or fallopian tube cancer that did not respond to previous     treatment with cisplatin or carboplatin. Drugs used in chemotherapy, such as SJG-136, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing.   "
159130|NCT01200784|"     Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum     phosphate levels of dialysis patients in a dose dependent manner.   "
159131|NCT01200771|"     Fever of unknown origin (FUO) and chronic inflammatory syndrome could be seen in many     affections. The diagnostic process is still a challenge and could not be specified yet after     several clinical studies performed by trained teams using two levels diagnostic procedures.     For this reason, the diagnosis involves many additional and expensive tests such as computed     tomography (CT scan), scintigraphic imaging, endoscopy, biopsy. There is no evidence-based     recommendation for the diagnostic work-up of FUO or chronic inflammatory syndrome. Positron     emission tomography with 2-[18F] fluoro-2-deoxy-D-glucose combined with CT scan (FDG-PET/CT)     is widely used in malignant diseases and seems to be promising for the diagnosis of     inflammatory disorders. Its role has not been yet clearly defined in the investigation of FUO     and chronic inflammatory syndrome.   "
159132|NCT01200758|"     This two-stage, multi-center, randomized, controlled, open-label study will investigate the     pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants     with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized     to receive 375 milligrams per meter square (mg/m^2) rituximab as IV infusion or 1400     milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy.     Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will     receive maintenance treatment for a further maximum number of 12 cycles. Maintenance     treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was     designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum     Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3     weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1.     Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with     rituximab IV. The anticipated time on study treatment is 96 weeks.   "
159133|NCT01200745|"     The purpose of this study is to determine whether topical capsaicin patch can effectively     reduce chronic neck pain.   "
159134|NCT01200732|"     A preliminary observational study by the investigators has shown that tadalafil, a selective     phosphodiesterase-5 inhibitor (PDE-5) decreases pulmonary vascular resistance(PVR) in     patients of eisenmenger syndrome (ES) resulting in increase in pulmonary blood flow (Qp),     systemic oxygen saturation (SaO2), functional class and exercise capacity. The aim of this     placebo controlled trial was to assess the effect of the drug on exercise capacity and     functional class compared to placebo.   "
159135|NCT01200719|"     To investigate the efficacy of using transcranial alternating current stimulation (tACS) to     enhance the regaining of neurological function among post-stroke patients.   "
159136|NCT01200706|"     The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or     three times a day to children with non-severe community-acquired pneumonia.   "
159137|NCT01200693|"     BACKGROUND:      Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI). The     selection of the type of drug-eluting stents (DES) and the technique for stent implantation     have not been clarified. The side-branch (SB) is emerging as critical point, accounting for     more than a third of the significant restenosis in the DES era. A series of data supports the     adoption of a conservative strategy: stenting the main vessel (MV) only and reserving a     conservative approach on the SB. Yet, the clinical relevance in terms of inducible ischemia     of sub-optimal angiographic result has not been clarified.      AIMS OF THE STUDY:      The aims of the present study are:        1. to compare in a prospective study the acute 3D angiographic results and the late          clinical outcome of Sirolimus-eluting (SES) vs Everolimus-eluting (EES) vs Zotarolimus          eluting stent (ZES) obtained using a provisional TAP-stenting technique.        2. to prospectively assess the clinical relevance (inducible ischemia) of suboptimal          angiographic result in the SB after stenting.      METHODS TO BE APPLIED:      75 consecutive patients with bifurcated lesions undergoing PCI with the provisional     T-and-small-protruding (TAP) technique with ZES implantation will be enrolled. Procedural and     post-PCI details will be prospectively recorded. The subgroup of patients in which complete     revascularization has been achieved will enter a systematic assessment of inducible ischemia     by early and late exercise tests.      Off line 3D quantitative coronary angiography (QCA) assessment will be performed and used to     divide the study population in 2 groups according to the SB residual stenosis:        -  Group O (optimal SB angiographic result): post-PCI SB area stenosis<50%        -  Group S (sub-optimal SB angiographic result): post-PCI SB area stenosis>50%.      For the comparison among SES and EES, data will be obtained from the randomized trial     SEA-SIDE (NCT00697372).      PRIMARY STUDY END-POINTS.        1. COMPARISON BETWEEN ZES, SES AND EES:           SB acute angiographic result; SB trouble; target bifurcation failure.        2. SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization:          inducible ischemia at the early exercise test or occurrence of early spontaneous          ischemia related to the SB.   "
159138|NCT01200680|"     Background:      Chordoma is a rare, slow growing, often fatal bone cancer derived from remnants of the     embryonic notochord. It occurs mostly in the axial skeleton (skull base, vertebrae, sacrum     and coccyx), is more frequent in males than females, and has a median age at diagnosis of     58.5 years, with a wide age range. This typically sporadic tumor is often advanced at     presentation, and mortality is high due to local recurrence or distant metastases. The usual     treatment is surgery, followed by adjuvant radiation therapy. Chemotherapy has not had a     significant treatment role. Reports of a small number of families worldwide with two or more     relatives with chordoma support a role for susceptibility genes in chordoma etiology.     Recently we determined that duplications of the T gene co-segregated with disease in four     multiplex chordoma families. The T gene encodes brachyury, a tissue-specific transcription     factor that is expressed in notochord cells and is essential for formation and maintenance of     the notochord. Some of the other chordoma families that we studied did not have T-gene     duplications; the aggregation of chordomas in these families may result from changes in other     susceptibility genes or other types of mutations targeting the T gene. We are continuing gene     identification studies of multiplex chordoma families at the NIH Clinical Center under     protocol 78-C-0039. We also want to determine whether alterations in any identified chordoma     susceptibility genes are associated with sporadic chordoma in the general population.      Objectives:      The major goal of this protocol is to identify sporadic chordoma patients willing to provide     germline and tumor DNA for studies to determine the frequency of alterations in chordoma     susceptibility genes. Our previous protocols with SEER and Massachusetts General Hospital to     identify chordoma patients were limited to residents of specific geographic regions in the     U.S. (2 states and 2 metropolitan areas) or to patients with pediatric skull base tumors.     This protocol will enroll patients who more broadly represent the age, site and gender     distributions of sporadic chordoma in the general U.S. population.      Eligibility:      Eligible patients are males and females in the U.S. with chordoma diagnosed at any age and at     any primary site. Because we want to obtain saliva from all participants, eligibility is     limited to patients who will be greater than or equal to age 6 years at the time of     enrollment.      Design:      The study description and contacting information including an e-mail link to the study     contact person will be posted on web sites of two chordoma support groups. We will mail study     information to be given to patients to colleagues at major medical centers that treat     chordoma.      The components of the study will be carried out in subjects' homes using materials mailed to     them. Up to 100 participants will: 1) complete a self-administered Personal and Family     Medical History Questionnaire, 2) collect saliva using a saliva collection kit, and 3)     provide permission to obtain medical/pathology records, and paraffin blocks or slides on each     primary chordoma. Parents will serve as proxies for minor children.      We will recontact patients who report chordoma in at least one blood relative. If we confirm     the relative's chordoma diagnosis, we will invite the study subject and selected family     members to participate in clinical and gene mapping studies under protocol 78-C-0039. We may     also recontact study participants to tell them about any new studies on chordoma etiology.     They can decide at that time whether they want to participate in them.   "
159540|NCT01195363|"     To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment     with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three     thereof, in a group of patients with an index episode of a mixed state in BD.   "
159141|NCT01200641|"     Principle goals of sedation for eye surgery are to provide patient comfort and to allow the     patient to stay calm during both retrobulbar injection and surgery. Insufficient sedation may     not prevent the patient from moving during retrobulbar injection, whereas very deep sedation     may result in respiratory complications during surgery .The investigators compared the effect     of melatonin and gabapentin on the hemodynamic parameters, sedation ,anxiety, and pain and     satisfaction profile in cataract surgery. After approval by the Hospital Evaluation Committee     of Scientific Studies for ethical purpose and written informed consent, ninety patients     scheduled for cataract surgery by phacoemulsification were randomly allocated to three study     groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or     placebo(GroupP, n=30) 90 minutes before retrobulbar injection. . Hemodynamic parameters     ,anxiety, sedation score , and pain during block and surgery, satisfaction of surgeon were     assessed. . At the preoperative visit verbal pain score (VPS) of 10 (0 = no pain and 10 =     worst pain imaginable) and verbal anxiety score (VAS) ranging from 0 to 10 (0= completely     calm, 10 = the worst possible anxiety) were explained to patients. Then a 20 gauge cannula     was inserted into one of the two hands. Patients were monitored with electrocardiogram,     noninvasive measurement of blood pressure, and pulse oximetry (SPO2). Retrobulbar nerve block     was performed by the same ophthalmic surgeon who was unaware of group allocation with 1.5 ml     of solution that prepared by nurse( lidocaine 2%and 0.5 ml bupivacaine) via the percutaneous     route with a 25 G, 38 mm Atkinson needle (John Weiss & Son Limited, Milton Keynes,England),     at inferotemporal site. No patient received an additional facial nerve block. The     investigators assessed the pain immediately after block and surgery. Anxiety score and pain     score was recorded in each patient before premedication (T1), ninety minutes after     premedication, on arrival in the operating room (T2), one minute after retrobulbar block     placement (T3)during the operation period) (T4) and postoperatively before discharging the     patient from the recovery room (T5) .At the end of surgery, the patients were asked about     average level of their anxiety and pain during the operation period according to the VAS and     VPS explained to them before premedication.`. The surgeon was also asked to verbally rate     their level of satisfaction according to three degree scale as very bad, , moderate, good     after the operation. The sedation level of patients during performance of block was assessed     as Sedation scores were obtained on a 3 point scale with 0 =movements of the head, arms and     trunk ,1 =slightly movement of arms,2=slightly change in face,3=complete calm. If sedation     was inadequate, fentanyl could be given 0.5microgram/kg as needed.   "
159142|NCT01200628|"     Posttraumatic stress disorder (PTSD) is a serious and often chronic response to     overwhelmingly stressful events as Road Traffic Accident. Moreover PTSD is associated with     increased rates of medical morbidity, poor health-related quality of life, and functional     impairment. PTSD is prevalent in primary care settings after road traffic accident, where     approximately 25% of patients meet diagnostic criteria for the disorder. Despite the     development of a number of efficacious behavioral and pharmacological treatments, only a     minority of patients with PTSD receive mental health services. PTSD is frequently     underrecognized and untreated in Emergency Department and Surgical Unit.      Then, early diagnosis and prevention of PTSD might help to identify patients with PTSD high     risk and lead them to benefit of personalized cares. Nevertheless it is not possible (neither     useful) to provide psychological cares for each road traffic accident victim.      This is the reason why we think that nurses can help to screen patients who need treatment     for PTSD Hypothesis : Recognition of specific clinical or biological signs occurring during     road traffic accident victim hospitalization in surgical unit could allow beginning specific     treatment using consultation liaison psychiatry.      Early treatment could allow decreasing incidence of psychotraumatic disorders, increasing     surgical functional efficacy and improve convalescence programs. The use of a specific     questionnaire could help to screen this disorder.      We have created the DEPITAC scale : a short screening questionnaire with 10 items.      This study will be evaluated DEPITAC's 10-item screen for posttraumatic stress disorder     (PTSD) for use in surgical or emergency department.   "
159143|NCT01200615|"     In this study we invetigate the influence of the nocebo effect (as part of obtaining informed     consent) on the prevalence of side-effects. The study is prospective, focusing on the     connection between what the physicians says to the patient about side-effects to the     frequency of these side effects during treatment period. We also inquire whether informing     the patient about the existence of the nocebo effect influences the extent of phenomena.   "
159144|NCT01200602|"     RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by     cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or     anorexia in young patients with malignancies who are undergoing radiation therapy and/or     chemotherapy.   "
159145|NCT01200589|"     This is a multi-center, parallel, active comparator controlled, open-label, randomized (1:1)     phase III study of single agent ofatumumab compared to single agent rituximab in subjects     with rituximab-sensitive indolent B-cell non hodgkin lymphoma that has relapsed at least 6     months after completing treatment with single agent rituximab or a rituximab-containing     regimen. Subjects must have attained a Complete Response or Partial Response to their last     prior rituximab containing therapy lasting at least six months beyond the end of rituximab     therapy. Subjects will receive four weekly doses of single agent ofatumumab (1000 mg) or     rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2     months for four additional doses. Therefore, subjects will receive a total of eight doses of     anti-CD20 antibody over 9 months. Subjects will be evaluated for response after completion of     the first four doses of therapy, after six doses of therapy, and after completion of study     therapy. Subjects will be followed until the end of the designated follow-up period (total     study duration of 200 weeks) or until they meet the withdrawal criteria.   "
159146|NCT01200576|"     This one-year observational study will monitor the contraceptive effectiveness, safety and     acceptability of Zarin during the first year of use after the method has been approved for     public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical     support from Marie Stopes International and FHI. 300 women of reproductive age who selected     Zarin as their primary method of contraception will be enrolled in the study at the MSM     outreach sites and static clinics.   "
159147|NCT01200563|"     The purpose of this study is to evaluate the clinical and economic effectiveness of MIST     Therapy vs NPWT vs MIST Therapy in conjunction with NPWT in the treatment of full thickness     wounds presenting in the LTACH and SNF settings.   "
159149|NCT01200537|"     The purpose of this randomized controlled trial is to compare the efficacy and effect of     luteal estradiol and combined oral contraceptive pills (COPC) on follicle recruitment and     synchrony in a poor responder population. The randomized groups consist of: 1. patients     receiving luteal estradiol prior to ovulation induction; and 2. patients receiving COCPs for     1 month prior to ovulation induction. Follicle characteristics and serum biomarkers will be     followed and compared in each group. Coefficient of variation will be used to evaluate     follicle size discrepancy. Chi square analysis will be used to compare categorical variables     between treatment groups. Both estradiol and COPCs are used clinically in assisted     reproduction, so this study affords no additional risks to the participants.   "
159150|NCT01200524|"     A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days     treatment in patients with posttraumatic neuralgia.   "
159154|NCT01200472|"     STUDY DESIGN:      This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group,     efficacy and safety study in 30 patients with erosive osteoarthritis of interphalangeal     joints. The study is composed of 4 phases: a pre-randomization phase for up to 35 days     followed by a 91-day randomized, double-blind two arm treatment phase, followed by a 77-day     open label treatment phase for all study participants and a 28-day observational follow-up     phase. Efficacy of the double blind and open label phase will be assessed at study day 84 and     168 after treatment start respectively.      STUDY DURATION:      The study length will be approximately 231 days for individual patients. With approximately a     12 month recruitment period the study is planned to last from January 2010 until July 2011     (19 months).      STUDY OBJECTIVES:      The primary objective is to evaluate the 84-day efficacy of apremilast 20 mg twice per day     [BID], subsequent to a 7-day dose titration, compared with placebo, for the treatment of the     symptoms of erosive hand osteoarthritis. Further objectives are to evaluate the effects on     pain, disease activity, structural damage, quality of life, safety and tolerability.   "
159155|NCT01200459|"     The Social/Mobile Approach to Reduce Weight (SMART) study is a 24-month randomized control     trial designed to evaluate the hypothesis that weight status at 24 months will be     significantly better for the SMART intervention recipients than for those who receive the     comparison condition.   "
159156|NCT01200446|"     Docosahexaenoic acid (DHA) is a component of fish oil that is known to support a healthy     cardiovascular system, maintain brain function, reduce depression, and improve inflammatory     diseases. The study hypothesis is that DHA supplementation will diminish exercise-induced     bronchoconstriction and airway inflammation as compared to placebo.   "
159157|NCT01200433|"     The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood     flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the     investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol for     cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by     near-infrared spectroscopy.   "
159158|NCT01200420|"     The main purpose of this study is to determine the safety and tolerability of multiple dosing     of miravirsen in subjects infected with chronic hepatitis C.      Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of     miravirsen's effect on HCV viral titer.   "
159159|NCT01200407|"     The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine     and Olmesartan medoxomil among Hypertensive Filipino patients.   "
159160|NCT01200394|"     PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791     will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure,     improving renal function.   "
159161|NCT01200381|"     It's the aim of this study to analyze the benefit of personal patient / physician contacts in     heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or     ICD with cardiac resynchronization therapy (CRT-D).      The personal follow up (in clinic or phone calls) will be compared to completely automatic     remote follow ups.      All patients will receive remote monitoring for automatic daily alarm checks and will undergo     in clinic follow ups in 12 months intervals   "
159162|NCT01200368|"     Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group     1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular     pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP,     Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar     (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be     open-label. The main purpose of the study is to determine if the immune responses to 13vPnC     are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given     with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to     evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given     with DTaP in healthy Japanese infants.   "
159176|NCT01200186|"     Prospective, non-interventional, multi-center study. Each subject will be followed for up to     twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin     Only Pill). For each subject demographic data and medical history will be documented at Visit     1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and     wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2     (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.   "
159997|NCT01189292|"     The study is to compare the postoperative recovery, as determined by postoperative nausea and     vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in     patients undergoing partial or total thyroidectomy.   "
159163|NCT01200355|"     The purpose of this study is to compare the effects, good and/or bad, of posaconazole and     micafungin in preventing fungal infections after chemotherapy for acute leukemia or     myelodysplastic syndrome. When people take chemotherapy, they are more likely to get     infections. Posaconazole has been approved for the prevention of fungal infections in     patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome.     Posaconazole is available only as an oral suspension and has to be given with food. After     chemotherapy, many patients are not able to tolerate food or oral medication because of     severe mucositis. Patients unable to tolerate food and oral medications cannot take     posaconazole.      Micafungin is an antifungal medication that is given only intravenously. Micafungin is     approved for the treatment of certain fungal infections and for preventing fungal infections     in patients who receive bone marrow transplant. The investigators know that micafungin is     safe. Micafungin has not been tested for the prevention of fungal infections in patients     receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin is     given by vein, it can be given even in patients who cannot take food or medications by mouth     after chemotherapy. In this study the investigators want to compare micafungin to     posaconazole when given for the prevention of fungal infections in leukemia and     myelodysplastic syndrome patients.   "
159164|NCT01200342|"     The goal of this clinical research is to learn if the combination of Genasense (oblimersen),     carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety     of this combination will also be studied.   "
172666|NCT00093327|"     The purpose of this study is to determine whether acupuncture is effective in reducing the     symptoms of irritable bowel syndrome (IBS).   "
159166|NCT01200316|"     After having abdominal surgery, patients often experience a lack of bowel function that can     cause nausea, vomiting, abdominal swelling, pain, and/or discomfort. This is known as     post-operative ileus. Patients are usually not allowed to leave the hospital until their     doctor is sure that their bowel function has returned.      The goal of this clinical research study is to compare using a rocking chair to the standard     of care in improving post-operative ileus after abdominal surgery.   "
159167|NCT01200303|"     The purpose of this study is to evaluate the performance of a non-cathartic,     computer-assisted form of CT Colonography (Virtual Colonoscopy) for detection of     pre-cancerous colon polyps in a group of asymptomatic screening patients.   "
159168|NCT01200290|"     The purpose of this trial is to explore the effect of LY2127399 on those antibodies that are     a barrier to kidney transplant. Transplantation is currently the definitive treatment for     End-Stage Renal Disease (ESRD), providing prolonged survival and improved quality of life.   "
159169|NCT01200277|"     The standard care in patients with a painful osteoporotic vertebral compression fracture     (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), is a new minimally invasive     technique for pain treatment in which bone cement is injected in the fractured vertebra.     Recent RCTs provide conflicting results: two sham-controlled studies show no benefit of PV     while an unmasked but controlled RCT found significantly better pain relief after PV at     acceptable costs.   "
159170|NCT01200264|"     This is a Phase II, open label, investigator-initiated study to be done at Duke University     Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have     failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks. At the time of enrollment,     the patient must have received biologic therapy without achieving a response of almost     clear or clear according to PGA or has not responded with a 75% reduction of PASI score.     Once deemed eligible, subjects will return for a baseline visit and receive Apremilast     therapy and instructions. Subjects will be treated at weeks 0,4,8,12,16,20 and 24; subjects     will be evaluated 28 days after last dose of Apremilast for safety and efficacy.   "
159171|NCT01200251|"     A internally controlled, single-blinded, randomized controlled trial to investigate the use     of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who     suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and     IRB approval have been obtained.   "
159172|NCT01200238|"     STA-9090 is drug which inactivates or blocks the work of a protein called Heat Shock Protein     90 or HSP90. HSP90 is a protein that helps some molecules inside the cells have the right     shape. By stopping it's activity, these molecules never get to have the right structure to be     functional and they are destroyed. We believe that if we stop the activity of HSP90, the     rapidly dividing cells in the tumor(s) will slow down since their proteins will not be     functional without the help of HSP90.   "
159173|NCT01200225|"     This prospective observational study will assess the insulin resistance and its impact on     sustained virological response in patients with hepatitis C treated with Pegasys and Copegus.     Data will be collected from each patient during the up to 72 weeks of treatment and for 24     weeks of treatment-free follow-up.   "
159174|NCT01200212|"     The purpose of this study is to determine whether        -  Paclitaxel and bevacizumab showed improved PFS compared to paclitaxel alone. Recent          results of the AVADO study report a similar result for the combination of docetaxel and          bevacizumab. The AVADO study furthermore confirmed the dose of 15 mg/kg BW of          bevacizumab.        -  As in metastatic breast cancer (MBC) poly-chemotherapies are frequently used, regimens          with bevacizumab and at least 2 cytotoxic agents should be investigated.        -  Docetaxel and capecitabine showed a benefit in PFS and survival. This combi- nation is          therefore a reasonable choice.        -  Dose of capecitabine and docetaxel should be reduced to 1800 mg/m2 and 75 mg/m2 to          improve tolerability without compromising efficacy.        -  Paclitaxel and capecitabine is well tolerated and showed a PFS of 10.3 months.        -  Docetaxel 100 mg/m2 as monotherapy in MBC not very often used b/o toxicity. 75 mg/m2          much more accepted in daily practice. Better comparability with DBX, if both arms have          75mg/m2 docetaxel as assumed.   "
159175|NCT01200199|"     The purpose of this study is to contribute to the validation of an electronic daily diary to     assess symptoms in patients with varicose veins.   "
159467|NCT01196338|"     The primary objective of the investigators randomized controlled trial is to determine if     early protected weightbearing and ankle range of motion after surgical treatment (open     reduction internal fixation - ORIF) for ankle fractures improves the rate of return to work     and functional outcome compared to postoperative ankle immobilization in a non-weightbearing     cast.   "
159177|NCT01200173|"     This multicentric, randomized, double-blind and controlled study aims to examine the effect     of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001     (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common     infectious diseases (cumulated number of infections during the intervention period: primary     criteria) in children aged 3-6 years, attending day care centers.Volunteers received either     200g/day of tested product (N=300) or control product (N=299) for 3-months, followed by a     1-month follow-up.   "
159178|NCT01200160|"     Post-Marketing Observational study of Niaspan® tablet in accordance with each country     regulations. This study will be conducted in a prospective, single-arm, multi-center format.     As this study is observational in nature, the follow-up of subject's is not prescriptive in     nature and is according to the judgment of the physician (investigator in the course of     treatment for each patient), within the period of observation of 12 months. This includes an     enrollment period of 6 months in which each subject will be observed for approximately 6     months. Examinations, diagnostic measures, findings and observations performed as per usual     medical practice during the observation period will be recorded on Case Report Forms (CRFs)     by the investigator or site staffs according to the protocol.   "
159186|NCT01200056|"     While statin treatment may induce plaque regression, the effect of statin on plaque     composition with varying doses is unknown. This study assessed such effects by volumetric     virtual histology intravascular ultrasound (VH-IVUS).      In this prospective, randomized, double-blinded pilot study, statin-naïve patients with     stable angina requiring percutaneous coronary intervention (PCI) were randomized to receive 6     months of either atorvastatin 10mg or 40 mg daily. VH-IVUS was performed in all non-PCI     lesions at baseline and 6 months; all analyses were performed by core laboratory.   "
159179|NCT01200147|"     Dysphagia is a common reason for referal to the investigators Gastoenterology service. As     many as 14% of patients undergoing radiological studies for dysphagia are found to have     schatzki rings. Current recommendations for treatment of patients with symptomatic Schatzki     rings are based on ancedotal experience and uncontrolled studies. The only randomized study     on comparison of techniques the investigators were able to locate was published in 2000 and     included only 26 patients. This study demonstrated that the biopsy techinque was as effective     as and better tolerated than the standard dilation technique. Considering that the cost and     time required for dilatation is greater than the basic biopsy technique, significant cost     savings could be achieved using the biopsy technique. As well, patient satisfaction is an     important factor considering that Schatzki rings can recur and repeated endoscopy is often     required. Therefore, a study that shows a technique to be as or better than the current     standard in effectiveness, cost, time, and patient comfort could lead to shift in current     practice.   "
159180|NCT01200134|"     Background :      In malignant gliomas, hypoxia is associated with tumour angiogenesis and tumour progression.     This multidisciplinary preclinical and clinical project aims to validate the use of 18F-FMISO     as a hypoxic marker for diagnosis, treatment and follow-up of malignant gliomas. Indeed,     non-invasive methods of imagery such as Positron Emission Tomography (PET) and biological     methods (after surgical resection) to detect the endogenous expression of factors induced by     the hypoxia would allow to identify hypoxic areas. Identifying, with accuracy, the hypoxic     areas could allow the clinicians to evaluate the response to the anti-angiogenic agents     (preliminary validation in the preclinical project) and to optimize the combination of the     anti-VEGF treatments with other conventional therapeutic approaches (radiotherapy,     chemotherapy or other molecules).      Research project :      This research project includes 3 steps : first the investigators will establish the 18F-FMISO     production technique for clinical application at CYCERON PET center. The second step consists     in the preclinical validation of 18F-FMISO as a hypoxic marker and as a powerful tool for     evaluating the therapeutical efficiency of anti-angiogenic treatment (sutent) in experimental     rat gliomas. The third step is the clinical trial HypOnco. This research proposal aims to     develop and use non invasive imaging methods (18F-FMISO with PET) and biological methods     (after surgical resection) to detect hypoxic (HIF1 and HIF2) and angiogenic (VEGF and EPO)     regions in different malignant gliomas with different degrees of vascularization (15 patients     with grade III gliomas and 15 patients with grade IV glioblastomas). Within the same patient     18F-FMISO as a hypoxic index will be performed. A magnetic resonance imaging examination     (MRI) including perfusion sequences and MR spectroscopy will also be assessed for each     patient. Following this imaging protocol, surgical resection will be performed allowing us to     study expression of endogenous factors induced by hypoxia and angiogenic factors by real time     RT-PCR and in immunohistochemistry.      The data obtained will enable us to establish :        -  a hypoxic index (18F-FMISO with PET).        -  an index of hypoxic factor expression (HIFs)        -  an angiogenic index (VEGF, EPO, vascular markers)      The investigators will characterize the links between these data and also with the following     parameters:        -  clinical (age, Karnofsky performance status, survival)        -  MR parameters included perfusion and spectroscopy        -  histological (necrosis, cellular proliferation, atypical cell abnormalities,          vascularization).      Expected results and clinical advantages        -  To establish the 18F-FMISO production technique        -  To propose the 18F-FMISO as a non-invasive marker for efficacy of antiangiogenic          treatment in a preclinical study.        -  To define the relationship between the 18F-FMISO uptake and tumour grade, patient          survival, tumour recurrence, expression of hypoxic and angiogenic factors and tumour          vascularisation.        -  To provide a hypoxic index in cerebral tumours from 18F-FMISO PET, allowing diagnosis          and prognosis improvement for optimal treatment orientation and strategy.      In the field of the clinical applications, this tool will allow to :        -  Optimize radiotherapy treatment by identifying with accuracy, using 18F-FMISO PET, the          most hypoxic areas which are also the most radio resistant.        -  Evaluate antiangiogenic therapy efficacy   "
159181|NCT01200121|"     Malignant ascites represents a severe clinical problem for physicians and patients being     confronted with this common symptom of advanced-stage gastrointestinal cancer. Unfortunately,     there is no standardized and evidence-based treatment for malignant ascites and therapies     which are commonly being used are only temporarily effective. Newer modes of therapy, such as     the application of the tri-functional antibody catumaxomab, are associated with significant     side effects and are limited to patients in stages of good overall performance. Therefore,     there is still an urgent need for more effective, longer-lasting, and less toxic modes of     treatment for peritoneal effusions caused by gastrointestinal cancers.      Preclinical data strongly suggest that bevacizumab might be a very effective agent for the     treatment of malignant ascites, which is in large part caused by the     hyperpermeability-promoting factor VEGF. Emerging clinical results from cancer patients with     malignant ascites treated with bevacizumab add further support to this idea. Bevacizumab has     been tested in a variety of large clinical trials, has a good toxicity profile, and is     effective in a number of human cancers underlying malignant ascites.      In the present study, Bevacizumab will be administered as an intraperitoneal infusion at an     absolute standardized dosage of 400 mg. This dosage was chosen because it is comparable to     the approved standard dosage for intravenous administration which was also used in both     studies reporting the successful and safe intraperitoneal administration of Bevacizumab to     patients with malignant ascites. Finally, a standardized dosage seems more practical in the     particular patient population treated in this study.   "
159182|NCT01200108|"     The goal of treatment with AICS is weaning from oral corticosteroids, i.e. a reduction of the     oral corticosteroid dose. An anticipated treatment benefit of AICS is a reduction of oral     corticosteroid dose and stability/improvement of clinical parameters related to asthma in the     targeted subject population. Ultimately, the goal is to free subjects with severe asthma from     the burden of chronic oral steroid therapy.   "
159183|NCT01200095|"     This study presents an arthroscopic-assisted PCL reconstruction using femoral knot/press-fit     technique with a periosteum-enveloping graft in tibial tunnel. The investigators evaluated     the results of patients with PCL ruptures, who undergoing PCL reconstruction using this     unique technique.   "
159184|NCT01200082|"     The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary     elimination can be used as a biomarker to predict the severity and prognosis of hepatobiliary     diseases. The investigators rationale in this project is that the discovery of biomarkers     specific to liver injury would provide the foundation for a specific and non-invasive tool to     evaluate disease prognosis, determine patients with higher risk of developing end-stage liver     diseases, and determine patients with higher risk of recurrence of hepatobiliary     complications after liver transplant. The investigators propose the following specific aims     to test the investigators hypothesis:      Specific Aim #1: Establish a baseline of individual and total urinary BAs and BA-sulfates in     healthy controls and patients with hepatobiliary diseases. A baseline reference of the     average and distribution of the percentage of urinary BA-sulfates will be determined in     healthy subjects and in patients with hepatobiliary diseases including chronic hepatitis C/B,     alcoholic liver disease, hereditary, drug-induced, and autoimmune hepatobiliary diseases. The     investigators working hypothesis is that patients' capability to sulfate total or specific     BAs, as determined by the percentage of total or specific BAs excreted in the sulfate form,     can predict the severity of hepatobiliary diseases, as determined by mayo model for end-stage     liver disease (MELD) score and compensation status(compensated and decompensated). Patients     with higher MELD score are considered to be at higher risk of developing severe hepatobiliary     complications.      Specific Aim #2: Determine the relationship between BA sulfation and the progression of     hepatobiliary diseases. This is an exploratory aim to collect preliminary data on the     relationship between urinary BAs and the progression of hepatobiliary diseases in     liver-transplant and non-liver-transplant patients, as monitored over a1-year period. The     investigators working hypothesis is that patients' capabilities of sulfating BAs determine     the progression of the disease.      Patients on the liver transplant list are continuously monitored during their hospitalization     and are scheduled for follow-up visits for 12 months after their release post-surgery.     Disease progression will be evaluated by monitoring MELD scores, survival, incidence of liver     transplant, and incidence of complications related to hepatobiliary conditions such as fluid     retention, GI bleeding, encephalopathy, and biliary stricture complications.   "
159206|NCT01199783|"     Objective of the study is to test whether Daptomycin (6 mg/kg bodyweight) is non-inferior in     treatment of severe diabetic foot infections (MRSA) in comparison to antibiotic treatment     with Vancomycin (effective blood-plasma concentration of 15 mg/l). In case of     microbiologically confirmed gram-negative co-infection effective antibiotic treatment     according to microbiologic analysis will be administered upon medical decision in both     therapy groups. The study will be carried out as a randomized, open label study.   "
159512|NCT01195727|"     CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in     pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban     in pediatric subjects with a central venous catheter.   "
159185|NCT01200069|"     Post-procedure myalgia (muscle ache) is a well-known and common complication of     Electro-convulsive Treatment (ECT). Myalgias are a serious concern of patients and occur in     approximately 50% of these cases. The pain is usually described as muscle soreness, similar     to that resulting from strenuous exercise. The myalgias typically begin shortly after the     procedure, lasting approximately 2-7 days in total. A recent study reported that 89% of     patients considered prevention significant and would be willing to pay a median of $33 out of     pocket to avoid this side effect. In addition to patient discomfort, myalgias can have a     further financial burden if these patients are unable to return to work or resume previous     daily activities in the days following the procedure. An agent that could treat and possibly     even prevent these myalgias has the potential to be very beneficial to these patients. IV     ibuprofen (trade name Caldolor) is a novel therapeutic modality approved by the US Food and     Drug Administration (FDA) in June 2009 for the treatment of mild to moderate pain, as an     adjunct to opioid analgesics, and for the reduction of fever.   "
159247|NCT01199250|"     This research study is studying biomarkers in samples from patients with endometrial cancer.     Studying samples from patients with cancer in the laboratory may help doctors learn more     about changes that occur in DNA and identify biomarkers related to cancer.   "
159187|NCT01200043|"     The sugar fructose has been implicated not just as a cause of obesity, but as a cause of the     metabolic diseases that go along with obesity, termed metabolic syndrome. Obese children     with metabolic disease will be studied before and after 10 days of a fructose restricted     diet. The question is whether their co-morbidities will improve, even if weight remains     constant.   "
159188|NCT01200030|"     The investigators hypothesize that application of electrical stimulation would augment the     effects of exercises in patients with stroke. Combined electrical stimulation with exercises     for 6 weeks would lead to earlier and greater improvement in motor functions when compared     with placebo-stimulation with exercises.   "
159189|NCT01200017|"     This protocol provides expanded access to bone marrow transplants for children who lack a     histocompatible (tissue matched) stem cell or bone marrow donor when an alternative donor     (unrelated donor or half-matched related donor) is available to donate. In this procedure,     some of the blood forming cells (the stem cells) are collected from the blood of a partially     human leukocyte antigen (HLA) matched (haploidentical) donor and are transplanted into the     patient (the recipient) after administration of a conditioning regimen. A conditioning     regimen consists of chemotherapy and sometimes radiation to the entire body (total body     irradiation, or TBI), which is meant to destroy the cancer cells and suppress the recipient's     immune system to allow the transplanted cells to take (grow). A major problem after a     transplant from an alternative donor is increased risk of Graft-versus-Host Disease (GVHD),     which occurs when donor T cells (white blood cells that are involved with the body's immune     response) attack other tissues or organs like the skin, liver and intestines of the     transplant recipient. In this study, stem cells that are obtained from a partially-matched     donor will be highly purified using the investigational CliniMACS® stem cell selection device     in an effort to achieve specific T cell target values. The primary aim of the study is to     help improve overall survival with haploidentical stem cell transplant in a high risk patient     population by limiting the complication of GVHD.   "
159190|NCT01200004|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of Grifola frondosa extract, azacitidine, and lenalidomide that can be given to     patients with advanced cancer. The safety of this drug combination will also be studied.   "
159191|NCT01199991|"     Dual-energy x-ray absorptiometry (DXA) is currently the most widely used tool for determining     bone density. However, most experts consider DXA an imperfect and intermediate technology.     DXA is subject to artifact from arthritis and body composition, and also cannot account for     geometric or material properties of bone which are also important components of bone     strength.      Xtreme CT (high-resolution peripheral quantitative computed tomography, HR-pQCT) is a new     technology with dramatically improved spatial resolution. It is able to define bones'     cortical and trabecular surfaces in a three-dimensional manner, and therefore provides     information on bone microarchitecture as well as bone density. As such, it may provide new     information about characteristics of bone strength.      The purpose of this study is to compare Xtreme CT to DXA measurements of bone density, and     also to generate a normative database of healthy young adults. This cross-sectional study     involves a single visit where both Xtreme CT and DXA measurements will be obtained for a     single time-point. This normative database will allow us to generate clinically relevant     comparisons between the two imaging technologies.   "
159192|NCT01199978|"     In this research study we are looking at another type of radiation called proton radiation     which is known to spare surrounding normal tissues from radiation. The proton radiation will     be delivered using fractionated stereotactic radiotherapy (FSRT) to improve localization of     the small tumor target. Proton radiation delivers minimal radiation beyond the area of the     tumor. This may reduce side effects that patients would normally experience with conventional     radiation therapy. In this research study, we are looking to determine the effects of     fractionated proton radiotherapy on long-term hearing preservation and controlling tumor     growth.   "
159193|NCT01199965|"     Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation     (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.      Identify whether there are clinically significant differences in the tolerability of MAP0004     between smokers and non-smokers.   "
159227|NCT01199510|"     The purpose of this study is to evaluate the effectiveness of FID 112903 (SYSTANE ULTRA®     Lubricating Drops) plus standard of care to standard of care alone, in subjects with a     history of intermittent eye irritation or dryness related to environmental factors and     scheduled for routine cataract surgery.   "
159578|NCT01194856|"     The purposes of this study are to evaluate if switching an antiretroviral medication from     efavirenz (EFV) to atazanavir/ ritonavir (ARV/r) will, in a 96-week period, change:        1. the amount of fat in HIV patients with lipoatrophy,        2. metabolic lab values such as your lipid (fat) profile, glucose (blood sugar), and          insulin (a hormone that regulates glucose) in HIV patients with lipoatrophy.   "
159194|NCT01199952|"     Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the     treatment group than in the control group.      Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion     in women who choose combined hormonal contraception (CHC) and who receive a three-week     educational phone call as compared to women who do not receive the intervention.      Secondary Aims        -  To describe the most common concerns and logistical problems women experience with          initiating and adhering to CHC after abortion.        -  To describe the concerns that lead to discontinuation or method change. *To assess          feasibility of conducting a follow-up telephone call in this population This is a          randomized, controlled trial to assess the effect of a three-week follow-up phone call          in women who choose combined hormonal contraception on the day of their abortion at the          San Francisco General Hospital Women's Options Center. Subjects randomized to the          treatment group will receive an interventional phone call three weeks after their          abortion; participants randomized to the control group will not receive the call. All          subjects will receive a follow-up call six weeks after their abortion to assess and          compare method use between the two groups. Calls will be made at three- and six-weeks          post abortion in order to give subjects enough time to initiate CHC and to assess          continuation into the second month of the method. Data will be collected at baseline,          during the intervention for the treatment group and during the final follow-up call for          both groups. The primary outcome is use of an effective contraceptive six weeks after          abortion.   "
159195|NCT01199939|"     This study is a Phase II single arm, open-label, multicenter, study of 50 human     immunodeficiency virus-1 (HIV) infected adult patients, all of whom will receive etravirine     (ETR) 400mg and DRV/r 800/100mg each given orally once daily. This trial is designed to     evaluate the efficacy of the aforementioned ARV regimen, as measured by the percentage of     patients with HIV RNA <50 copies/mL at 48 weeks, in early treatment-experienced HIV-infected     patients. In addition to general safety parameter measurements, this trial will also assess     changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will     occur over a 6-week period. The primary endpoint will be assessed at Week 48, and the     treatment period is 48 weeks. The end of study endpoint will be met by either completing the     Week 48 visit, or by early termination from the study for any reason.   "
159196|NCT01199926|"     The study was designed to assess the effects of vitamin D supplementation during exercise     training on body composition, muscle function, and glucose tolerance. The investigators     hypothesis for these studies is that vitamin D supplementation enhances exercise-induced     increases in strength and lean mass, potentially through enhancing insulin sensitivity and     reducing inflammation.   "
159197|NCT01199913|"     The use of desflurane in elderly subjects (>65 years old) undergoing general anesthesia with     endotracheal intubation will result in decreased POCD compared to sevoflurane if the     patient's MAP is within 20% of the patient's baseline and the cerebral suppression state     index stays within the moderately anesthetized range during general anesthesia.   "
159198|NCT01199900|"     This study will investigate the effect of a single dose of PF-04171327 or prednisone on     calculated measures of glucose tolerance and insulin resistance by using a modified oral     glucose tolerance test   "
159199|NCT01199887|"     This is an open label, Phase One, multicenter study, designed to evaluate the safety,     tolerability, to explore the biologic effects, and to explore the clinical effects of the     following doses of IW001: 0.1mg/day, 0.5 mg/day, and 1.0 mg/day, when administered once a day     orally for 24 weeks in patients with IPF.   "
159200|NCT01199874|"     Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all     diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and     Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy     data in low income countries had prevented WHO from making a universal recommendation of     their use until recently. This study will be conducted in Pakistan and will look at two     objectives:        1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of          life and at 6, 10 and 14 weeks of life.        2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of          vaccine administration with infants whose breast feeding is withheld for one hour before          and after vaccine administration.   "
159201|NCT01199861|"     This study will evaluate the effect of treatment with fingolimod on the immune response     following seasonal influenza vaccination and tetanus booster injection in patients with     relapsing MS.   "
159202|NCT01199848|"     The purpose of this study is to test whether compounds found in strawberries (polyphenolics     which are typically found in berry products, tea, coffee, red wine, and chocolate) will help     reduce insulin resistance and inflammation, known factors in your blood associated with     disease risk, when eaten with a standard high fat/carbohydrate meal.   "
159203|NCT01199835|"     The aim of the study is to investigate the long time effects of high and low intake of dairy     products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation     and appetite regulation in moderately overweight men and women over 24 weeks.   "
159204|NCT01199822|"     Participants in this single-center, open-label, dose-escalation, Phase 1 study will initially     receive intravenous (IV) olaratumab once every 2 weeks or on Days 1 and 8 every 3 weeks for 6     weeks (one cycle). After the first cycle, participants experiencing an overall response of     complete response (CR), partial response (PR), or stable disease (SD) will continue to     receive olaratumab at their cohort dose and schedule until there is evidence of progressive     disease (PD), or until other withdrawal criteria are met.   "
159205|NCT01199809|"     This randomized, double-blind. placebo-controlled study will assess the safety, tolerability,     pharmacokinetics and pharmacodynamics of multiple doses of RO5310074 in patients with     psoriatic arthritis who have or have had an inadequate response to oral disease-modifying     antirheumatic drugs (DMARDs) or non-steroidal anti-rheumatic drugs (NSAIDs). Patients will be     randomized in cohorts to receive either 6 intravenous doses of RO5310074 or placebo.     Anticipated time on study treatment is 12 weeks.   "
159621|NCT01194427|"     This research study is designed to look at the effects of the combination of vorinostat     (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The     investigators will do this by comparing tissues from the original breast biopsy to tissues     obtained after taking vorinostat and tamoxifen for 2 weeks.   "
159207|NCT01199770|"     Investigators are interested in learning how appetite responds to pasta containing different     amounts of protein and fiber when provided in two different portion sizes.      In this research study, subjects will be asked to eat an entire pasta serving containing     different amounts of protein and fiber mixtures. Subjects will be asked to do this on six     separate occasions. One time subjects will not receive pasta, only water.      After the pasta serving, there will be a buffet of deli style lunch items and subjects may     eat as much they desire. Thereafter subjects will describe their feelings of hunger, fullness     and desire to eat for 3 hours. In addition, blood will be taken throughout the study period     to determine how eating pasta servings in different portion sizes impacts certain hormones     released from the intestine, and therefore how they influence appetite. All study visits will     take approximately 4 ½ - 5 hours.   "
159208|NCT01199757|"     Previous publications have indicated that Allergic Rhinitis (AR) patients suffering from both     ocular and nasal symptoms have a greater burden of illness and lower quality of life than     patients suffering from nasal symptoms alone. Fluticasone furoate (FF) acts against both     nasal and ocular symptoms. The purpose of this study was to evaluate the differences in     symptom control (both perceptually and objectively) and resource use for patients with     current seasonal AR.   "
159259|NCT01199094|"     The aim of the study is to describe patients with a high bone mass phenotype due to a     mutation in the low density lipoprotein l receptor 5 gene (LRP5) and compare them with age     and sex matched controls. Moreover, bone density and microarchitecture as well as markers of     bone metabolism are evaluated   "
159209|NCT01199744|"     To collect background information of patients receiving a prescription for Relenza® and study     risk factors etc. for adverse drug reactions collected through spontaneous reporting. In     particular, to characterize the types and incidences of adverse events, serious adverse     events, and adverse drug reactions and to investigate risk factors for them in patient     populations that are regarded to be at high risk for novel influenza A (H1N1)and in which the     use experience of Relenza® has not been enough (such as pregnant women, infants, elderly     persons, and those with decreased physical function) in accordance with the PFSB/SD     Notification 0904, No.2 of the Safety Division, Pharmaceutical and Food Safety Bureau, MHLW,     dated 4th September 2009.      To compare the data with the safety data collected in overseas sentinel site monitoring     programs.   "
159210|NCT01199731|"     This 48 week, phase 2b study in 150 HIV-1 infected antiretroviral therapy experienced adult     subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and     200 mg once daily with a control arm of open-label etravirine (ETV) 200 mg twice daily. The     background ART for all three arms will be darunavir/ritonavir (DRV/r) 600 mg/100 mg twice     daily plus raltegravir (RAL) 400 mg twice daily. Antiviral activity, safety, PK, and     development of viral resistance will be evaluated.   "
159211|NCT01199718|"     This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability, and highest     safe dose level of this CK2 inhibitor in patients with relapsed or refractory multiple     myeloma.   "
159212|NCT01199705|"     The objective of this study is to assess the efficacy, safety, tolerability, and     pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary     immunodeficiency (PID). In addition, the study will assess the health-related quality of life     and pharmacoeconomic aspects related to treatment with IgPro20.   "
159213|NCT01199692|"     Traditional dietary, lifestyle, behavioral and pharmacologic treatment strategies have proven     relatively ineffective for treating obesity, and once metabolic abnormalities such as Type 2     Diabetes (T2D) develop, definitive strategies to prevent major cardiovascular events remain     elusive. More positively, the identification of a scientific resolution for obesity and T2D     in the short-term is not outside the bounds of reality. Because the complexity of metabolic     regulation is likely to include already characterized biomarkers, as well as other     unidentified factors, it is logical to sample subjects of various ages, gender, ethnicity,     body mass distribution, dietary habits, exercise habits, medication requirements, and disease     states to discover associations and pathways related to the restoration of normal metabolism.   "
159214|NCT01199679|"     The purpose of this study is to determine the safety and effectiveness of two separate     procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two     therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band     Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using the     Cook® Duette™ Multi-Band Mucosectomy device.   "
159215|NCT01199666|"     Although the investigators have reached the Healthy People 2010 goal of 80% coverage among     U.S. children 19-35 months of age for the primary immunization series, 20% of children still     remain underimmunized. In addition, pockets of low immunization coverage and outbreaks of     vaccine preventable disease persist. Immunization reminder-recalls have been shown to be     successful, but have been limited by the ability to identify and reach large target     populations in a real-time, automated fashion. Reminder-recalls via text message may offer an     innovative opportunity to improve vaccination coverage. Currently, 91% of Americans own a     cell phone. Prior research by our team suggests that text messages reminder recalls may be an     effective tool to remind parents about their children's vaccines. In this study, the     investigators will demonstrate the effectiveness of tailored text message appointment and     immunization reminders linked to a well-established and functional immunization registry to     increase coverage rates and timeliness of the sentinel vaccines of MMR and HepA. The     investigators will target parents of young children from an underserved population that is     primarily Latino, with low socioeconomic status.   "
159216|NCT01199653|"     The purpose of this study is to find whether to operate or treat conservatively dislocated     midshaft clavicle fractures.   "
159217|NCT01199640|"     This was a phase 2a study of MLN1202 to determine safety, tolerability and initial efficacy     in patients with relapsing-remitting multiple sclerosis (RRMS). It was conducted in 2 dose     cohorts enrolling a total of 50 patients. Efficacy was assessed by comparing the numbers of     new gadolinium-enhancing brain lesions during the screening and treatment periods.   "
159228|NCT01199497|"     Multicenter clinical trial, phase III, controlled by active medicine, double-blind,     randomized, enroll 208 subjects, above 12 years old, that suffer acute inflammation upper     airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3     and no more than 5 consecutive days (without systemic/topic use of medication during this     period) followed by nasal congestion, with or without associate other nasal symptoms     (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated     in 2 parallel groups, and will receive the medicines of study, according of the     randomization.   "
159218|NCT01199627|"     The bleeding caused by hip replacement surgery (CRT) is an important source of demand for     blood in the hospital. Tranexamic acid (TXA) is a drug that has proved useful in reducing     bleeding associated with other surgeries and CRT results have been positive, but the variety     of dosages difficult to evaluate the results To determine the efficacy and safety of TXA in     reducing bleeding caused by surgery of total hip replacement.      PATIENTS: Patients ASA(American Society of Anesthesiologists) I-III that they are to perform     hip replacement surgery and cementless unilateral total that have signed the informed     consent.      Group A: 1st dose 15mg/kg of TXA in 100ml saline 0.9% after the completion of regional     anesthesia, and before the start of surgery.      2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after     the first administration.      Group B: 1st dose: 10mg/kg of TXA in 100ml 0.9% saline after the completion of regional     anesthesia, and before the start of surgery.      2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at     three hours after the first administration.      Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the     completion of regional anesthesia, and before the start of surgery.      2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after     the first administration.      STATISTICAL ANALYSIS Comparison of blood loss in groups and comparison of adverse events   "
159219|NCT01199614|"     This is an open-label study of PTH(1-84) treatment that seeks:        1. To determine the actions of PTH(1-84) to provide long term control of serum calcium and          urinary calcium excretion with use of standard amounts of calcium and vitamin D          supplementation.        2. To determine the extent to which PTH(1-84) improves quality-of-life on long-term basis.        3. To establish the safety of PTH(1-84) when administered for up to 12 years.        4. To attempt to quantify improvements in the typical signs/symptoms of hypoparathyroidism          post PTH administration.      There will be one visit conducted every six months in the study offices of the principal     investigator, Dr. John Bilezikian. In addition to these visits, there will be, for new     patients who have not used PTH (1-84) before, a Screening Visit four weeks prior to the     baseline visit for the purpose of performing screening labs as well as a Pre-Baseline Local     Quest Lab performed to ensure stability prior to Baseline.   "
159220|NCT01199601|"     Baseline information indicates there are measurable levels of hepatitis B SAg and low     utilization of postpartum contraception, correct breastfeeding practices, or adherence to     infant vaccination schedules in Kabul, Afghanistan. This intervention will randomize     hospitals to assess the following aims:      Aim 1: To determine whether the re-training and assignment of health care providers dedicated     to intrapartum rapid testing and post-partum counseling will positively impact maternal and     neonatal health indicators as compared to utilization of existing health providers for these     services among women delivering in publish health maternity hospitals in Kabul, Afghanistan.      Aim 2: To assess whether patients randomized to the intervention and their spouses perceive     value in concentrated post-partum counseling.      Aim 3: To investigate whether an intervention providing immediate post-partum provision of a     long-acting family planning method would be feasible and acceptable to both men and women in     Kabul, Afghanistan.   "
159221|NCT01199588|"     This study is for subjects with a venous leg ulcer. The study is being done to determine if     NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.   "
159222|NCT01199575|"     The Chronic Lymphocytic Leukemia (CLL) Research Consortium (CRC) is conducting a two-arm,     multi-center phase II trial of Revlimid® and rituximab for Relapsed or Refractory CLL for     patients under the age of 65 and patients 65 years and older.      Lenalidomide (Revlimid) is an immunomodulatory agent with promising clinical activity in CLL     and is FDA approved for treatment of relapsed multiple myeloma and 5q-myelodysplastic     syndrome. Rituximab (Rituxan) is a monoclonal antibody to CD20 that is approved for the     treatment of CLL.      The primary objective of this study is to determine the overall response rate of the     combination of Revlimid® and rituximab in previously treated CLL patients. All patients will     receive treatment with Revlimid® starting at a low dose that will be dose escalated based on     individual patient tolerability. The combination of Revlimid and Rituximab will be     administered for a maximum of 7 cycles. Patients with residual leukemia following seven     cycles of treatment with the combination may elect to continue on protocol for an additional     6 cycles of single agent Revlimid® consolidation.   "
159223|NCT01199562|"     RATIONALE: Infection prophylaxis and management may help prevent cytomegalovirus (CMV)     infection caused by a stem cell transplant.      PURPOSE:This clinical trial studies infection prophylaxis and management in treating     cytomegalovirus infection in patients with hematologic malignancies previously treated with     donor stem cell transplant.   "
159224|NCT01199549|"     Cardiovascular disease (CVD) continues to rank high among the leading causes of morbidity and     mortality in adults worldwide. While diet and increased physical activity constitute the     primary preventive health approach, the role of plant-based bioactive compounds has attracted     much attention due to their unique cardio-protective benefits. Several epidemiological     studies suggest that dietary patterns characterized by relatively high intake of fruits and     vegetables are significantly associated with reduced risks of coronary heart disease and     stroke.      Dietary bioactive compounds are potent anti-oxidants and anti-inflammatory agents, thereby     counteracting oxidative damage and inflammation, which underlie the pathogenesis of CVD.      However, this area is really lacking of a good set of chemistry, bioavailability and efficacy     data that is vital for nutrition researchers and doctors to emphasize their role in the     prevention and treatment of clinical outcomes at different stage of CVD, and dissemination of     this information to the general public.      Cambridge Theranostics has focused its efforts on developing products that can prevent the     damaging oxidation of lipoproteins that leads to heart attacks and stroke, and on     understanding the cause of that damage.      Extensive literature shows that Lycopene, Resveratrol and Soy Isoflavones are key ingredients     in diets that long been known to reduce the risk of heart attack and stroke. However, they     are normally poorly absorbed (not 'bioavailable'). The investigators unique production     process presents Lycopene, Soy Isoflavones and Resveratrol to the body in a form that it can     easily absorb and use.      The aim of the current study is to perform and compare bioavailability and absorption of     those three different dietary antioxidants and their combinations. The study is funded by     Cambridge Theranostics and will be done on healthy volunteers of various ages with 30 people     in each product group. It will be conducted on the primacies of Cambridge Theranostics in     Babraham Research Campus. And managed by the team of experienced professionals employed by     Cambridge Theranostics. The study will last about 12 months including recruitment process,     screening process, periodical blood samples collection and examination and statistical     analyses at the end.   "
159225|NCT01199536|"     The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to     estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the     end of treatment and 52 weeks from the therapy start   "
159226|NCT01199523|"     The objective of this study is to evaluate the effect of repeat oral dosing of mirabegron on     ECG (electrocardiogram) measurements.   "
159229|NCT01199484|"     Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be a     potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that     SOTI should be started early in order to improve its efficacy and prevent CMPs sensitization     from evolving towards persistent allergy. The aim of this study was to evaluate the safety     and efficacy of SOTI in 2-year-old children with cow's milk allergy, as a treatment     alternative to elimination diet.      Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to CMPs     were included in this multicenter study and were randomly divided into two different groups.     Thirty children (group A: treatment group) began SOTI immediately, whereas the remaining 30     (group B: control group) were kept on a milk-free diet and followed-up on for one year.   "
159260|NCT01199081|"     Primary Objective:      - Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to     different timings of Dronedarone initiation.      Secondary Objective:        -  Explore potential PK interaction between Dronedarone and Amiodarone        -  Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from          randomization up to 60 days after)        -  To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety   "
159230|NCT01199471|"     This registry is primarily aiming to demonstrate the correlation between good practices of     anesthesiologists and patient related outcomes including decreased overall anesthesia cost.     The investigators would also like to demonstrate how the training background, and experience     in inhalational anesthesia of the anesthesiologist influence their daily practice. At the end     of the registry, the investigators would be able to demonstrate the influence of different     practice pattern on patient related outcomes between the sites at which anesthesiologists     follow modern anesthesiology practice based on their training/experience background and at     which anesthesiologists do not follow same type of practice due to lack of their inhalational     anesthesia training/experience.   "
159231|NCT01199458|"     This study evaluates the effects of adding an opioid (alfentanil) during anesthesia induction     with respect to the barrierpressure in the esophagogastric junction.      The secondary aim was to investigate whether the effect of cricoid pressure influences the     barrierpressure.   "
159232|NCT01199445|"     The project aims to evaluate the potential impact triple fortified rice grains, mixed into     natural rice grains, can have on vitamin A status if fed to school children in Southern     Thailand. Within a 60 day intervention study, changes in vitamin A status in young children     fed the fortified rice compared to children consuming non-fortified rice will be assessed.   "
159233|NCT01199432|"     This is a phase IV, prospective, single-center, open-label, randomized, controlled study.     Eligible patients are randomly assigned into three groups. The investigators propose to     evaluate and compare the efficacy and safety of different neoadjuvant chemotherapies in women     with primary breast cancer.   "
159234|NCT01199419|"     The objective of the present study is to analyze the cost-effectiveness of percutaneous     coronary intervention (PCI) using TAXUS stents compared to the costs of coronary artery     bypass surgery (CABG) in patients with multivessel coronary artery disease (CAD) in the first     5 years and then 10 years after intervention. Multivessel PCI or CABG was performed in 114 or     93 patients, respectively. Clinical outcomes, in terms of incidence of acute myocardial     infarction (AMI), all-cause death, target vessel revascularization (TVR) and stroke, resource     use and costs are analyzed prospectively over a 5 and 10-year follow-up (FUP) period. Overall     costs consist of the baseline costs of the index procedure (PCI or CABG), clinical and     angiographic procedure-related treatments during the entire FUP. The primary endpoint is     cost-effectiveness and clinical effectiveness, defined as the reduction of the composite of     major adverse cardiac and cerebrovascular events (MACCE).   "
159235|NCT01199406|"     To determine the effect of combined intracutaneous infiltration and intraperitoneal     instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic     cholecystectomy on abdominal pain up to 24 hours after surgery.   "
159236|NCT01199393|"     The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes     can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.   "
159237|NCT01199380|"     Depression related vulnerabilities are highly comorbid with smoking behavior and dramatically     reduce cessation rates among both community and clinical samples. Previous research has     examined the efficacy of cognitive-behavioral treatment for individuals with a history of     major depressive disorder (MDD) in standard cessation treatment. A broader health impact can     be achieved by targeting individuals with current elevated depressive symptoms to address     their association with cessation failure. Thus the objective of the present proposal is to     conduct a Stage II randomized controlled trial (RCT) comparing the behavioral activation     intervention to standard treatment among a similar community sample of 200 adult smokers with     elevated depressive symptoms. Participants will be followed over 52 weeks post-quit date and     the larger sample size will allow for more complex analysis of cessation outcomes.   "
159238|NCT01199367|"     This study will determine the highest dose of KW-2450 in combination with lapatinib and     letrozole that can be administered safely to subjects with advanced or metastatic breast     cancer and to evaluate its effectiveness.      This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.   "
159239|NCT01199354|"     The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy     and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy     and radiotherapy in invasive breast carcinoma.   "
159240|NCT01199341|"     The primary purpose of this study is to determine whether the treatment with AZD1981 affect     the exposure of Warfarin.   "
159241|NCT01199328|"     The purpose of this study is to assess the interaction between aspirin and Nexium in healthy     volunteers.   "
159242|NCT01199315|"     The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446     in young and elderly healthy Japanese volunteers.   "
159243|NCT01199302|"     This study is an open label extension of study 20090072 with subjects with Crohn's disease.     Subjects will receive 350 mg AMG 827 intraveneously every 4 weeks for approximately 2 and a     half years. The study will be evaluated for safety and efficacy of AMG 827.   "
159244|NCT01199289|"     The purpose of this study is to determine if AMG 827 is effective compared to placebo as     measured by change in Asthma Control Questionnaire (ACQ) composite scores.   "
159245|NCT01199276|"     The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD),     diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip     fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four     days post-surgery.   "
175345|NCT00137371|"     This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated     estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.   "
159246|NCT01199263|"     This randomized phase II trial studies the side effects and how well giving paclitaxel with     or without viral therapy works in treating patients with ovarian epithelial, fallopian tube,     or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them spreading. Viral therapy may be     able to kill tumor cells without damaging normal cells. Giving paclitaxel together with viral     therapy may kill more tumor cells.   "
159263|NCT01199042|"     Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab     polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter     Cheyne Stokes Respiration, or Complex Sleep Apnea.   "
159248|NCT01199237|"     Protective airway reflexes may be impaired in the postoperative period, creating the     potential for aspiration of gastric contents, even after a patient exhibits appropriate     response to command. Because assessment of airway reflex recovery is not possible in an     intubated patient, the clinician must make an empiric decision as to when a patient is safe     to extubate, and choose a combination of techniques least likely to result in pharyngeal     impairment. Adequacy of reversal of neuromuscular block by cholinesterase inhibitors (e.g.,     neostigmine) is unpredictable, especially in the presence of profound paralysis, and tactile     assessment of train-of four and sustained tetanus has shown poor correlation with objective     assessments. Protective airway reflexes may also be impaired during early recovery by the     anesthetics themselves, even when muscle relaxant has been avoided. In the absence of muscle     relaxant the investigators previously demonstrated that patients receiving an anesthetic with     higher tissue solubility, sevoflurane showed significantly greater impairment of swallowing     up to 14 minutes after response to command compared to patients receiving an anesthetic with     lower tissue solubility, desflurane. Therefore, we ask whether the combination of the more     soluble anesthetic and the presence of neuromuscular block antagonized by neostigmine may     create a multiplicative effect that might further prolong pharyngeal recovery. We plan to     randomly assign 100 patients scheduled to undergo surgery with general anesthesia to a     standardized anesthetic that includes 1) sevoflurane, rocuronium with 70 µg/kg neostigmine +     14 µg/kg glycopyrrolate antagonism (group S); or 2) desflurane, rocuronium with 70 µg/kg     neostigmine + 14 µg/kg glycopyrrolate antagonism (group D). Airway reflex recovery will be     judged as adequate by the patient's ability to swallow 20 mL of water without coughing or     drooling 5, 10, 15, 20, 30 and 60 minutes after response to command. Anesthetic (sevoflurane     or desflurane) will be discontinued after administration of reversal agent and recovery to     TOF (train-of-four) ratio of 0.7.   "
159249|NCT01199224|"     Compare the bioavailability of three veliparib formulations in subjects with solid tumors.   "
159250|NCT01199211|"     Prospective study on the structural and functional changes in the heart of adult women     assessed by echocardiogram and in lipid metabolism that occur in response to physical     training. Using echocardiogram we will characterize the early determinants of athletic     remodeling. We will also assess the effect of intense physical training on lipid metabolism,     focus on HDL subspecies and function.   "
159251|NCT01199198|"     The goal of this clinical research study is to learn if tolvaptan can help raise salt     (sodium) levels in the cancer patients' blood by removing extra body water as urine.   "
159252|NCT01199185|"     Obesity represents a chronic disease associated with significant cardiovascular disease (CVD)     morbidity and mortality. Weight gain in young adults adversely impacts the development of CVD     risk factors. Further, there is a clear relationship between weight loss in obese persons and     reduction in these CVD risk factors. Unfortunately, young adults are at high risk for weight     gain. Although the scientific literature contains a number of reports regarding successful     weight loss efficacy studies, young adults are typically underrepresented.      Cigarette smoking is the leading preventable cause of morbidity and mortality, but quitting     smoking frequently results in significant weight gain. Proactive tobacco quit lines using     behavioral smoking cessation interventions combined with nicotine replacement therapy (NRT)     have been shown to help persons quit smoking. However, concerns about post-cessation weight     gain have been reported as a significant barrier to quitting for many smokers particularly     young adults.      If an efficacious behavioral weight loss program could be combined with an efficacious     behavioral smoking cessation program that prevented or significantly attenuated     post-cessation weight gain, then a large public health benefit may result. Such a combined     weight loss/ weight gain prevention / smoking cessation program that used targeted     intervention strategies to young adults, removed barriers to participation, and utilize     interactive technology should be appealing to this age group. To date such a combined program     has not been tested in young adult cigarette smokers. Therefore, the objective of this     clinical trial is to develop and test a behavioral weight loss / weight gain prevention     intervention delivered through interactive technology that can be used in conjunction with an     efficacious tobacco quit line. A total of 330 participants will be necessary to adequately     address the following specific aims.   "
159253|NCT01199172|"     The proposed series addresses the prevention and treatment of voice problems in teachers.     Data in the literature clearly identify voice disorders as teachers' primary occupational     risk not only in the U.S. but also internationally. Moreover, voice problems constitute a     global women's health concern. Until recently, few reports have been available around the     treatment of these problems in teachers, and even fewer have addressed the equally important     question of prevention. The present studies are conducted within the context of a long-range     goal to identify effective intervention methodologies for both the prevention and treatment     of voice problems in teachers taking into consideration multicultural and linguistic factors.     The present studies will report pragmatic data around the effectiveness of two     theoretically-driven approaches to the prevention and treatment of voice problems in     teachers, (a) voice hygiene education (VH) and (b) voice hygiene education + voice production     training in resonant voice (VH+VP, essentially the Lessac-Madsen Resonant Voice Therapy     program). Participants will be student teachers in Pittsburgh and Hong Kong, who will be     followed from student teaching across their second full year of employment as a professional     teacher. The central aims are: [1] to evaluate the effectiveness of VH and VH+VP for the     prevention of future voice problems in student teachers who are vocally healthy at the outset     of the protocol, versus the treatment of voice problems in student teachers who already have     them at some level; [2] to evaluate the generality of the findings across teachers in the     U.S. and China, using appropriate linguistic and cultural adaptations of the interventions;     and [3] to evaluate the feasibility of an internet-based voice exercise and reporting program     as a supplement to face-to-face interventions. Ergonomic and personal factors will also be     evaluated for their differential ability to predict the risk for future voice problems in     teachers. The results should be useful at a practical level, and should also lay the     groundwork for future studies assessing similar issues around the prevention of voice     problems in teachers, in particular as influenced by multicultural factors within the U.S.     The results should also be useful for future studies investigating causal pathways in     interventions around these problems.   "
159254|NCT01199159|"     Total abdominal hysterectomy is known to be associated with operative blood loss, which can     lead to patients' morbidity. Misoprostol, a prostaglandin, has been shown to be effective in     reducing operative blood loss during myomectomy. It is the first study to investigate if     preoperative misoprostol is effective in reducing operative blood loss during total abdominal     hysterectomy.   "
159255|NCT01199146|"     This is a phase II, open label, single center study to evaluate the efficacy of abiraterone     acetate (CB7630) administered to patients with castrate resistant prostate cancer who have     experienced disease progression on ketoconazole.      It is hypothesized that abiraterone will be active in patients who have experienced disease     progression on ketoconazole   "
159256|NCT01199133|"     The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy     (SLIT) administered to children and adolescents as allergen-based tablets once daily over a     period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis     symptoms and rescue medication use.   "
159257|NCT01199120|"     Adequate nutrition is one of the critical biological processes to learning and cognitive     development of children. And is understandable that malnourishment affect these processes.     Moreover, in recent decades it has been investigated the beneficial effects of Omega-3 in     cognitive development and academic performance. However, studies have been limited. Therefore     is of interest to know the effects that has supplement with Omega-3 for children 8-12 years     with malnutrition in a randomized, blind, placebo-controlled.   "
159258|NCT01199107|"     The purpose of this study is to examine the efficacy of exercise in comparison to wellness     education to determine if they can improve the effects of prolonged exposure therapy (PE) in     reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In     addition, the two strategies (i.e., exercise and wellness education) will be compared in     terms of improvements in sleep as well as levels of brain-derived neurotrophic factor (BDNF).     BDNF is a protein that helps to support the survival of existing neurons and stimulate the     growth new neurons and synapses. BDNF is important to learning and memory in general and     therefore may be associated with the learning and memory as it relates to PE and     corresponding symptom PTSD improvement.   "
159265|NCT01199016|"     Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective     against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar.     It is expected that the effectiveness of Prevnar 13 against ear infections in children will     be similar to that observed following Prevnar. Pfizer has committed to conduct a     postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.   "
159266|NCT01198990|"     The goal of this study is to translate basic behavioral and social science discoveries into     effective behavioral interventions that reduce obesity and obesity related morbidity in Black     and Latino communities. This intervention will focus on promoting small changes in eating     behavior and increasing physical activity among Black and Latino participants in Harlem and     the South Bronx. The desired result from these activities is individual weight loss that will     be sustained years after participation in the study.   "
159267|NCT01198977|"     This is a clinical trial examining a brief motivational intervention to improve adherence to     exercise among individuals with MS to improve fatigue.   "
159268|NCT01198964|"     We will observe epileptic patients who already have electrodes implanted on the brain and are     receiving high-level brain stimulation for clinical purposes while testing their motor and     language function. We propose to do a limited, low-level brain stimulation to show that the     signatures of local activity in the target area change as an effect of brain stimulation. The     goal of this study is to understand the feasibility of a novel recurrent brain-computer     interface that could eventually promote targeted functional recovery in subjects who have had     a brain injury.   "
159269|NCT01198938|"     The investigators plan to evaluate the effect of postoperative melatonin administration on     postoperative delirium in patients undergoing vascular and cardiac surgery. A total of 302     patients older than 60, undergoing elective vascular surgery will be randomly divided into 2     groups: treatment and control. During the first 5 postoperative days patients will receive     sublingually either melatonin 5 mg or placebo at 9:00 pm. The patients will be assessed for     the signs of delirium, quality of sleep and severity of pain daily for the first     postoperative week. Screening of delirium will be performed by the specially trained research     assistant and based on the Confusion Assessment Method and the validated chart review.     Diagnosis of delirium will be confirmed by the psychiatrist. Incidence of delirium will be     compared between the groups.   "
159270|NCT01198925|"     Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and     is frequently used in the empirical treatment of hospital-acquired infections because of its     antipseudomonal activity. Similar to other beta-lactam antibiotics, piperacillin-tazobactam     exhibits time-dependent killing and the T > MIC appears to be the best outcome predictor.     Because a majority of infections are treated empirically, it is necessary to achieve a T >     MIC equal to 50% of the dosing interval (50% T > MIC) against the most likely pathogens,     including those with only moderate susceptibility The aim of this study is to compare the     same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous     infusion. A pharmacokinetic study will be performed in patients treated by extended (loading     dose 4 G/30 min followed by 4 X 4 G /3h) and continuous infusion (loading dose 4 G/30 min     followed by 16G /24h).      A population pharmacokinetic analysis with Monte Carlo simulations will be used to determine     95% probability of target attainment (PTA95) versus MIC   "
159271|NCT01198912|"     This is a randomized, double blind, placebo controlled, parallel group, study in patients     with chronic rhinosinusitis with or without nasal polyps. The objective is to test the     clinical efficacy of long-term low dose oral doxycycline on wound healing quality after     endoscopic sinus surgery.   "
159272|NCT01198899|"     The purpose of this study is to determine the prevalence of Fabry mutations in patients with     left ventricular hypertrophy (moderate to severe), as measured by echocardiography.This study     is a screening study   "
175623|NCT00141167|"     The primary purpose of this study is to evaluate the safety and efficacy of varenicline given     for a twelve week treatment period in comparison with placebo for smoking cessation.   "
159273|NCT01198886|"     The primary objective of this study is to evaluate changes in functional status that result     from an Exercise-Nutrition Program (ENP) targeted toward older adults residing at senior     housing facilities.      - The primary hypothesis is that over the 6-month intervention period subjects in the     intervention group will realize significant improvements in lower extremity function compared     to a control group.      Secondary objectives      To evaluate changes in nutritional status that result from the ENP.      - The secondary hypothesis is that subjects in the intervention group will realize     significant increases in circulating insulin-like growth factor-1 (IGF-1) and 25-hydroxy     vitamin D (25(OH)D) and demonstrate improvements in nutritional status compared to a control     group.      To evaluate changes in inflammatory status that result from the ENP.      - Subjects in the ENP group will exhibit reduced concentrations of circulating interleukin-6     (IL-6) compared with the control group.      To evaluate changes in psychosocial factors that result from the ENP        -  The related hypothesis is that over the 6-month intervention period subjects in the          intervention group will increase exercise self-efficacy, intrinsic motivation to          exercise, and satisfaction of psychological needs compared to a control group.        -  Additionally it is hypothesized that subjects in the intervention group will realize          improvements in mood and quality of life compared to a control group.      To assess the feasibility of conducting the Exercise-Nutrition Program in a senior housing     facility setting.   "
159274|NCT01198873|"     Primary Objective:      - Evaluate the effect of dronedarone versus placebo (standard therapy) in slowing the     progression of adverse left atrial remodeling in patients with atrial fibrillation (AF)     following 12 months of treatment.      Secondary Objectives:        -  Evaluate the effects of dronedarone versus placebo on left atrial function;        -  Evaluate the effects of dronedarone versus placebo on left atrial dimension;        -  Evaluate the effects of dronedarone versus placebo on left ventricular function (LVEF,          E, E', A, E/E')        -  Evaluate the safety and tolerability of dronedarone.   "
159359|NCT01197742|"     The Sweetheart register (Risk management of Diabetics with acute myocardial infarction)     documents both the prevalence of pathologic glucose metabolism in consecutive high-risk     patients with STEMI and NSTEMI in daily hospital routine as well as the anti-diabetic acute     and long-term therapy. Furthermore the register will provide data about the implementation of     new guidelines for the interventional and adjuvant medical therapy of STEMI and NSTEMI.   "
159275|NCT01198860|"     Phyllanthus Urinaria - Adenosma Glutinosum - Eclipta Prostrata - Ascorbic Acid combination     plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of drugs     derived from natural and artificial medicaments.      Has stronger effect on immune system, effective good against HBV replication. This is a     substantial new insight into the pathogenesis of disease, with a clear path toward clinical     application, or which would lead to a substantial advance and perfect in management or public     health policy.   "
159276|NCT01198847|"     To study whether a targeted intervention can prevent the development of overweight and     obesity among pre-school children in families with either one obese or two overweight     parents.   "
159277|NCT01198834|"     A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase     III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine     Topical Patch in the Treatment of Ankle Sprains   "
159278|NCT01198821|"     The purpose of this study is to:      Find out the largest dose of sodium bicarbonate that can be given with gemcitabine.      Determine if the combination of sodium bicarbonate and gemcitabine produces better control of     pancreatic cancer than gemcitabine alone.   "
159279|NCT01198808|"     Bladder cancer is generally susceptible to immunotherapeutic measures. The investigators will     characterize 40 patients with muscle-invasive bladder cancer regarding the existence and     frequency of tumorspecific T-cells and regulatory T cells. The found data will be correlated     to clinical data such as the cancer-specific survival and the response to chemotherapy.      It is hypothesized that those patients with a high number of Tregs and no tumor-specific     T-cells have a worse prognosis.   "
159280|NCT01198795|"     This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in     children 7 to 11 years of age with major depressive disorder (MDD).   "
159281|NCT01198782|"     The purpose of this study is to evaluate the safety and efficacy of FID 112903 given as an     immediate treatment replacement in dry eye subjects that discontinue at least 6 months use of     RESTASIS.   "
159282|NCT01198769|"     The purpose of this study is to assess immunogenicity and safety of Rotarix TM when     administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first     vaccination) who received Hepatitis B immunoglobulin after birth.   "
159283|NCT01198756|"     This study is designed to test the immunogenicity and safety of an investigational influenza     vaccine, in children compared to two other influenza vaccines.   "
159284|NCT01198743|"     Cancer is a DNA disease characterized by the presence of genetics alterations in cancer     cells.      The recent studies underline that these recurring alterations must be considered as a good     molecular marker. In fact, they could use for tumor DNA detection in different biological     fluids.      So, the main purpose is to define the presence of circulating tumor DNA in the patients     plasma with colorectal cancer, by the presence of mutation (KRAS, NRAS, BRAF, APC, TP53 and     MIRCOSATELLIE instability).      These molecular analysis will be done both in tumor and plasma samples,      This trial allows to characterize the prognostic value of circulating tumoral DNA presence in     colorectal cancer.   "
159285|NCT01198730|"     To determine the glucose regulation status of patients who were suspected to have CAD in     central Taiwan.   "
159286|NCT01198717|"     The aim of this study is to evaluate the progression of ET in children (aged 6-17years     inclusive) over a period of 5 years maximum. The study will also assess how children are     diagnosed, treatment options for those children with symptoms and events related to their ET     and the outcomes of those treatments.   "
159287|NCT01198704|"     Results of liver transplantation, the best theoretical treatment for HCC, are limited by     tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However,     these criteria are to restrictive and approximately 40% of patients denied by Milan criteria     may be cured by liver transplantation.      The purpose of this study was thus to prospectively evaluate factors predicting tumor     recurrence after liver transplantation for HCC and then to reassessed criteria for liver     transplantation.   "
159288|NCT01198691|"     The purpose of the study is to compare post operative pain, cost effectiveness, speed of     closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples     versus absorbable staples (Insorb) after Cesarean Delivery.   "
175624|NCT00141180|"     To evaluate the suitability of contact allergy as a method for the evaluation of c-chemokine     receptor-1 antagonist.   "
159289|NCT01198678|"     Currently marketed CGM sensors have an approved functional lifetime of up to 1 week.     Pre-clinical studies have demonstrated that GluSense-LTone 2e3 sensors may be used to     accurately monitor glucose levels for 30 days. The purpose of this study is to assess the     safety and functionality of the device in human patients for consecutive 15 days.      GluSense-LTone 2e3 as long term CGM, will require less sensor replacements and calibration,     meaning less patient interventions, and is therefore will be much more user friendly.     Moreover, GluSense-LTone 2e3 shows potentially increased accuracy, especially in the     critically important hypoglycemic range, meaning that better management of patient's     condition may be attained.   "
159290|NCT01198665|"     The urgent need for new effective therapy for T-cell lymphoma patients and promising results     observed so far in trials with RAD001(everolimus, mTOR inhibitor) strongly warrants the     investigation of RAD001 combined with CHOP as a first-line treatment in peripheral T-cell     lymphoma patients.      Thus, we designed a phase I/II study with the combination of RAD001 with CHOP chemotherapy     for newly diagnosed peripheral T-cell lymphoma patients.      Phase I        1. Primary objective           : To define the maximum tolerable dose        2. Secondary objective             -  To evaluate the dose-limiting toxicity             -  To evaluate the pharmacokinetics of RAD001             -  Pharmacogenomic profiling      Phase II        1. Primary objective           : To evaluate the overall response rate        2. Secondary objective             -  To estimate the time to progression             -  To estimate overall survival             -  Pharmacogenomic profiling   "
159291|NCT01198652|"     This is an open, post-marketing surveillance study obtaining data retrospectively on 300     women, of any age, treated with the BD-OTS for postpartum uterine bleeding.   "
159362|NCT01197703|"     The European Cardiac CT Registry has the unique potential to provide important data that will     help to clarify the clinical role of cardiac computed tomography (CT), to create guidelines     and recommendations for its use, and to identify the most important areas that require     specific further research.   "
159292|NCT01198639|"     A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than     45) and death within 1 yr after surgery has previously been reported. In order to confirm or     refute these findings, the investigators have designed a study which compares two methods of     administration for total intravenous anesthesia (propofol and remifentanil):        -  manual administration: the anesthesiologists are instructed to maintain the BIS value          between 40 and 60.        -  closed loop administration: an algorithm is used to maintain the BIS value between 40          and 60.      Based on previous studies, the amount of time that BIS is maintained above 40 is greater when     anesthetics agents are administered using closed loop compared with manual administration.   "
159293|NCT01198626|"     The purpose of this study is to determine the efficacy, safety and tolerability of     JNJ-32729463 compared to moxifloxacin for the treatment of subjects requiring hospitalization     for Community-Acquired Bacterial Pneumonia (CABP).   "
159294|NCT01198613|"     It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with     ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic,     allergen-derived peptide desensitising vaccine, currently being developed for the treatment     of ragweed allergy.      This study will look at the efficacy, safety and tolerability of two doses of ToleroMune     Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.   "
159295|NCT01198600|"     The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear     and how those factors affect contact lens replacement frequency.   "
159296|NCT01198587|"     Diarrheal diseases are the third leading cause of mortality in the world, with nearly 2     million deaths annually among children under age 5 years. Several clinical trials of oral     zinc supplementation performed in developing country populations have confirmed this     nutrient's efficacy in reducing the severity and frequency of diarrhea. The World Health     Organization (WHO) has recommended global use of zinc supplementation in all children with     diarrhea despite little or no data from trials in industrialized/developed settings. In the     United States over 4 million children suffer annually from diarrheal illness. Although     mortality is not a significant factor in U.S. cases, 75% of all cases present to medical care     resulting in over 200,000 hospitalizations annually for diarrhea. This has significant impact     on U.S. healthcare costs, with an average of $391 per outpatient treatment and $2,549 per     inpatient treatment spent on each episode of acute diarrheal illness. The goal of this study     is to evaluate the effectiveness of oral zinc in decreasing the duration of diarrhea in     children treated as outpatients and in decreasing the duration of hospitalization in children     treated as inpatients in an industrialized country. The results of this study promise to have     a substantial impact on the management of a common pediatric health problem, and could     conceivably affect direct and indirect healthcare costs to society.   "
159297|NCT01198574|"     Anemia and vitamin A deficiency (VAD) are major nutritional problems in the world and also in     Myanmar. Both nutrient deficiencies result from interaction of several causal factors, and a     better understanding of the etiology to interpret the prevalence and to formulate appropriate     measures to reduce these deficiencies is necessary. There is a growing concern on the role of     sub-clinical inflammation on the nutritional status indicators during the nutritional status     assessment. However, there is lack of information on the role of inflammation on the iron     supplementation. The adolescent period is a window of opportunity to improve the     preconceptional iron status of the girls and recently gained much attention. The purpose of     the study is to understand the role of inflammation on iron and vitamin A status during iron     and vitamin A supplementation. The findings will show the extent to which iron     supplementation has been hampered by inflammation and to formulate the necessary measures to     overcome the interference.   "
159298|NCT01198561|"     The objective of this study is to investigate the antidepressant efficacy of rTMS, and to     assess cortical metabolism before and after rTMS sessions in patients with major depression.     We also aimed to investigate differences between the responders and nonresponders to rTMS and     what would predict clinical response to rTMS.   "
159309|NCT01198418|"     This is a CCTG sponsored trial in collaboration with UCSD-AVRC investigators to get more     information about the methods that are used on the internet to provide information on how to     reduce the risk of giving or getting infections that are often or usually passed from one     person to another during sexual or intimate contact (sexually transmitted infection (STI)).     STIs include chlamydia, gonorrhea and syphilis. The purpose of this study is to develop     methods that will allow someone who is living with HIV an easy way that they can get     information and learn of ways on their own that can decrease their chances of getting     sexually transmitted infections and ways that they can reduce the chance that they may     transmit HIV to others.   "
159299|NCT01198548|"     This phase II trial is studying how well giving high-dose cholecalciferol works in treating     patients receiving combination chemotherapy and bevacizumab as first-line therapy for     metastatic colorectal cancer. Cholecalciferol during treatment may delay the development of     colorectal cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.     Giving cholecalciferol together with combination chemotherapy and monoclonal antibody therapy     may be an effective treatment for colorectal cancer   "
159300|NCT01198535|"     The purpose of this study is to determine if a new drug, RO4929097, can work with cetuximab,     a drug already approved for colorectal cancer, to help fight the patient's cancer. Cancers     arise as a result of abnormal control of gene expression. One of the pathways that gets     abnormally regulated in some cancers is the Notch pathway. RO4929097 is an investigational     drug that blocks the activation of the Notch pathway. It is hoped that by blocking this     abnormal activation, this drug may be helpful in patients with cancer but the investigators     do not yet know if that is true. Cetuximab is an antibody against epidermal growth factor     receptor and is known to have activity in metastatic colorectal cancer. Recent studies have     shown that people with colorectal cancers that contain a mutation in a gene called K-ras do     not benefit from receiving cetuximab. It is unknown if adding RO4929097 to cetuximab would     benefit patients who have tumors with this mutation.   "
159301|NCT01198522|"     Systemic treatment for advanced, non-resectable pancreatic cancer still having minimal impact     on the survival of patients. Even with the application of more potent gemcitabine-based     regimens, survival of more than 1 year is uncommon for advanced disease. Accordingly, there     is substantial unmet needs for the improvement of treatment options. The combination and     simultaneous application of tumor-targeted L19IL2 with gemcitabine could result in improved     anti-cancer efficacy, based on preliminary clinical and strong preclinical data.      The primary purpose of this Phase I study is to define a safe and potentially more active     treatment regimen of L19IL2 (escalating doses) combined with gemcitabine for advanced     pancreatic cancer patients. Also, early signs of anticancer responses of the     L19IL2/gemcitabine regimen will be assessed and compared to historical controls (gemcitabine     monotherapy).   "
159302|NCT01198509|"     Rheumatoid arthritis (RA) is an inflammatory form of arthritis that causes joint pain and     damage. RA attacks the lining of the joints (synovium), causing swelling that can result in     aching and throbbing, and eventually deformity. Even though there have been many advances in     the treatment of RA, psoriatic arthritis (PsA), and other inflammatory arthritis, doctors     still do not know what causes this inflammation in joints. It is likely that RA occurs as a     result of a complex combination of factors, including a person's genes; lifestyle choices,     such as smoking and diet; and things in a person's environment, including bacteria or     viruses. This study investigates the hypothesis that bacteria living in a person's mouth     and/or intestinal tract are responsible, at least in part, for the development of Rheumatoid     Arthritis. The investigators believe that by killing those bacteria with antibiotics, they     might be able to understand how the immune system works and, maybe, what causes RA.   "
159303|NCT01198496|"     1. Objectives and Hypothesis             1. Objectives:                This study evaluates whether strict BP management is useful for the prevention of               recurrent stroke.                Hypertensive patients with history of stroke are treated with stepwise multi-drug               therapy to achieve stricter BP target <120/80 mmHg in the strict BP control group               and less stricter BP target <140/90 mmHg or <130/80 mmHg for patients with current               DM/CKD/MI in the standard BP control group. The participants under the BP treatment               achieving their respective BP target will be followed for recurrence of stroke. The               study continues until the number of patients with the first recurrent stroke               reaches a total of 330 between the two groups. The occurrence rates of recurrent               stroke will be compared between the two groups.             2. Hypotheses The incidence of recurrent stroke will be lower in a strict BP control               group having lower BP target: <120/80 mmHg* than in a standard BP control group               having BP target <140/90 mmHg or <130/80 mmHg for current DM/CKD/MI in patients               with hypertension.        2. Study design This will be a multicenter, randomized, open-label study. The study          consists of a screening period, a titration period and a follow-up period. The screening          period is a period between the date of consent and the enrollment date. Hypertensive          patients with history of stroke are randomly assigned to either the strict BP control          group having the target of <120/80 mmHg or the standard BP control group having the          target of <140/90 mmHg without current DM, CKD or MI and <130/80 mmHg with current DM,          CKD or MI. The titration period is the period finding a treatment which achieves target          BP, and 24 weeks at maximum. Patients will be treated with stepwise multi-drug therapy          using an angiotensin-receptor antagonist, diuretic, calcium channel blocker and          aldosterone antagonist. The participants will be observed under the BP management for          their respective BP target. The study will be continued until the number of patients          with the first recurrent stroke reaches a total of 330 between two groups. The follow-up          period will be 3 years.      The recurrent rates of stroke in both groups will be compared from various aspects, and     strict BP management will be investigated on the usefulness in prevention of recurrent     stroke.   "
159304|NCT01198483|"     The purpose of this study is to compare refractive outcomes after two different types of     combined cataract surgery, namely microinscision cataract surgery and smallincision cataract     surgery, and sutureless 23-gauge vitrectomy in patients presenting with vitreoretinal     disorders and coexisting cataracts.   "
159305|NCT01198470|"     The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH®     Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc     Disease (DDD) at one level from L1 to S1.   "
159306|NCT01198457|"     Adherence (or compliance with) a medication regimen is generally defined as the extent to     which patients take medication as prescribed by their health care providers. The adherence to     medications has close relation to effectiveness of the therapy. The primary objective of this     study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days     covered, number of days in which clodronate is taken according to treating physician     recommendation) in patients with malignancy. The secondary hypothesis generating objective     is to describe the relation between adherence to treatment with oral clodronate and efficacy     of the therapy (skeletal events, pain).   "
159307|NCT01198444|"     Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives     efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral     treatment. The aim of the study is to evaluate in everyday practice the relation between     dosage errors and indicated factors, potentially influencing the compliance with the dosing     scheme.   "
159308|NCT01198431|"     The main aim of this study is to examine the effects of restricted sleep on energy and     substrate metabolism as well as relevant hormonal systems that might be involved in the     underlying mechanisms.      The investigators hypothesize that short-term sleep curtailment in adolescents is accompanied     by 1) increased hunger and desire to eat; 2) increased spontaneous energy intake; 3) reduced     spontaneous physical activity; and 4) increased fluctuation in hormones in a way that could     favour a positive energy balance and potentially weight gain on the long run.   "
159312|NCT01198379|"     The study is prospectively initiated to: (1) evaluate the alterations in platelet function to     aspirin therapy and the prevalence of aspirin resistance in patients with chronic kidney     disease undergoing hemodialysis, and (2) compare the incidence of vascular events (myocardial     infarction, cardiac death, stroke, vascular access thrombosis, or revascularization     procedure) and the safety profile among placebo-treated, aspirin-resistant and     aspirin-sensitive patients.   "
159313|NCT01198366|"     AERAS-402 will be given to infants of at least 16 weeks of age who have already been     vaccinated with BCG to determine if AERAS-402 will increase protection of infants to     tuberculosis.   "
159314|NCT01198353|"     This study is designed with the aim to evaluate the clinical effect of the overlapped     switching to ziprasidone as well as the efficacy and safe metabolic profile of ziprasidone.   "
159315|NCT01198340|"     To evaluate an analgesic effect without basal administration of local anesthetics for     patient-controlled femoral nerve block (with sciatic nerve block) after total knee     arthroplasty.   "
159316|NCT01198327|"     This study evaluates long-term safety in patients with macular edema due to Retinal Vein     Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials and subsequently followed in     the HORIZON extension trial.   "
159363|NCT01197690|"     The purpose of this study is to determine mean or median of fractional exhaled nitric oxide     (FeNO) in Thai atopic asthmatic patients that divided into subgroups due to level of asthma     control according to the global initiative for asthma guideline.   "
172942|NCT00105495|"     The purpose of this study is to determine whether deferiprone has superior efficacy in     removing excess iron from the heart when compared with deferoxamine.   "
159317|NCT01198314|"     Long-term immunosuppression carries potential adverse effects such as risk of infection,     malignancy, renal insufficiency, diabetes and hypertension. In clinical liver     transplantation, some liver transplant recipients maintain allograft function without     immunosuppressive drugs. This is called as operational tolerance. Many attempts have been     made to identify immunological biomarkers predicting operational tolerant patients.     Therefore, the investigators aimed to identify patients who have the potential to be     operationally tolerant using biomarkers, withdraw immunosuppressant gradually and stop     ultimately with monitoring of biomarkers.   "
159318|NCT01198301|"     The investigators want to develop a gene expression profile the for prediction the     chemotherapeutic response of patients with metastatic breast cancer.   "
159319|NCT01198288|"     This study will investigate if adding a domiciliary respiratory physiotherapy treatment to     standard care in patients with chronic obstructive pulmonary disease (COPD) can improve     physical function (walking test) and quality of life.   "
159320|NCT01198275|"     The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone     and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm     after electrical conversion in patients with persistent Atrial fibrillation (AF).   "
159321|NCT01198262|"     The purpose of this study is to determine whether the Cepheid GeneXpert system accurately     detects Methicillin-Resistant and -Susceptible Staphylococcus aureus in blood cultures and     wound swabs.   "
159322|NCT01198249|"     This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among     anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study     provides useful information to develop a new fixed dose combination drug.   "
159323|NCT01198236|"     Invasive fungal infections (IFI) remain the major cause of death among neutropenic patients     receiving chemotherapy for leukemia, or submitted to stem cell transplantation. Patients with     a history of invasive fungal infection (IFI) are at high risk of developing relapse and fatal     complications.      Prompt intensive antifungal therapy, have improved responses and survival, allowing an     increase of antifungal treatments, including secondary antifungal prophylaxis.      Few studies have addressed the role of previous IFI in the feasibility of stem cell     transplant, or the secondary prophylaxis with antifungal drugs in preventing recurrence of     infection after transplantation. However, given the lack of prospective studies, the role of     secondary antifungal prophylaxis remains unclear.      Itraconazole is a wide-spectrum triazole antifungal agent active against Candida albicans,     non-albicans, Aspergillus spp., Blastomyces dermatitidis, Blastomyces coccidioides,     Cryptococcus neoformans, Sporothrix schenkii, Paracoccidioides brasiliensis, Histoplasma spp.     and various kinds of yeast fungi and mycetes.      The role of itraconazole IFI prophylaxis treatment has been proved by many interventional     studies. In this prospective, multicentric study of secondary prophylaxis, itraconazole will     be given at standard dose to patients undergoing allogeneic stem cell transplantation or     chemotherapy with prior invasive fungal infection, to assess the efficacy and safety of     itraconazole secondary prophylaxis.   "
159324|NCT01198223|"     The aim of the present study was to compare the effect of aqueous extract of garlic with     nystatin mouthwash in denture stomatitis.   "
159325|NCT01198210|"     The immediate postoperative period after tonsillectomy, , is often difficult. These children     frequently have severe pain but postoperative airway edema along with increased sensitivity     to the respiratory-depressant effects of opioids may result in obstructive symptoms and     hypoxemia. Opioid consumption may be reduced by non-steroidal anti-inflammatory drugs, but     these drugs may be associated with increased bleeding after this operation.      Methods: One hundred sixty ASA I-II children 3-12 were randomized four groups of 40 each.     Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2     mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg     dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil     3 min prior to tonsillectomy. Study drugs were marked only with a coded number label. A     computer-generated table of numbers guided randomization. Modified Hannallah pain scale     [observational pain scores (OPS)], nausea, vomiting, bleeding, rescue analgesia, sedation and     Aldrete scores were recorded at first, 15th, 30th and 60th min postoperatively. Patients were     interviewed on the day after surgery to assess the postoperative pain, nightmares,     hallucinations, vomiting and bleeding. All the children were premedicated with midazolam     hydrochloride 0.3 mg/kg) and fentanyl 1micro g/kg intavenously. Anesthesia was induced with     thiopental 5mg/kg and atracurium0.3mg/kg. Anesthesia was maintained with isoflurane 1.5% and     nitrous oxide 30% in oxygen. The two surgeon used the same dissection and snare technique for     all cases and hemostasis done with bipolar cutter. At the end of the surgery neuromuscular     blockade was reversed by neostigmine 0.03 mg/kg) and atropine 0.01 mg/kg intravenously),     anesthesia was discontinued and the tracheal tube removed in the operating room when patients     were deep. After extubation the patients were taken to the postanesthesia care unit (PACU)     where an nurse who were unaware of the study drug observed the patients. The pain scoring     observer nurse in PACU was consistent. Time to awaken (from the end of anesthesia until the     patients opened their eyes on command) and time to the first administration of postoperative     analgesia were recorded. Pethidine in a titrated dose (total 1 mg/kg) was administered     intravenously for rapid pain relief to patients with a OPS score > 4 or who were crying     during two consecutive five minute observation periods until the child was comfortable.     Postoperative pain during the first 24 h was assessed using a four-point scale: 0 no pain, 1     mild pain, 2 moderate pain, 3 severe pain by questioning their parents. In the ward the     standardized postoperative analgesic technique was with acetaminophen supp (40 mg/kg followed     by three doses of 20 mg/kg at 6-hour intervals to be given as needed for pain. Pethidine in a     titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to     patients who had pain scale >3.Any supplementary analgesia , nausea and vomiting, bleeding,     sleep disturbance and nightmares that the child might have had as surgery were assessed     during a telephone follow up 24 h later.   "
159326|NCT01198197|"     Background:      - A small brain protein called nociceptin/orphanin FQ peptide (NOP) receptor may be involved     in several brain diseases such as anxiety, depression, drug abuse, and seizures. Researchers     are interested in testing a new radioactive chemical that will help locate NOP receptors in     the brain during imaging studies such as positron emission tomography (PET) scans. Because     this chemical has not yet been approved by the Food and Drug Administration, it is considered     to be an experimental drug.      Objectives:      - To investigate the effectiveness of the experimental chemical [11C]NOP-1A in imaging     studies of the nociceptin/orphanin FQ peptide (NOP) receptor.      Eligibility:      - Healthy volunteers between 18 and 50 years of age who are able to have imaging studies.      Design:        -  This study will involve three or four outpatient visits to the National Institutes of          Health Clinical Center. All participants will be screened with a full physical          examination, medical history, blood and urine tests, and electrocardiogram.        -  Participants will be involved in one or more parts of this three-part study as directed          by study researchers. Part 1 consists of brain imaging to study how the brain responds          to the chemical. Part 2 is a whole body imaging study to evaluate how the chemical is          distributed throughout the body after being administered. Part 3 is a set of testing and          retesting scans to determine how precise the drug is in locating the NOP receptors in          the brain.        -  Part 1: Participants will have a brain magnetic resonance imaging (MRI) scan. Then the          study drug will be administered and participants will have a brain PET scan. Blood          samples will be taken during the PET scan, and urine samples will be taken after the          scan. These tests will take up to 3 hours to perform.        -  Part 2: Participants will have a whole body PET scan that will last a maximum of 3          hours.        -  Part 3: Participants will receive the study drug and have two additional PET scans.          Blood samples will also be taken during this part.   "
159327|NCT01198184|"     This phase I trial is studying the side effects and best dose of giving gamma-secretase/Notch     signalling pathway inhibitor RO4929097 and temsirolimus together in treating patients with     advanced solid tumors. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 and     temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
159328|NCT01198171|"     This research study is studying racial and genetic biomarkers of response in tissue samples     from patients with endometrial cancer. Studying samples of tissue from patients with cancer     in the laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. DNA analysis of tumor tissue may also help doctors predict how     well patients will respond to treatment.   "
159330|NCT01198145|"     RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing     pelvic radiation therapy.      PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works     in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation     therapy.   "
159331|NCT01198132|"     The aim of this multicentre, randomised, double-blind, placebo-controlled study is to     evaluate the efficacy and safety of supplementary treatment with cholecalciferol (vitamin D3)     in subjects with relapsing multiple sclerosis (R MS) treated with subcutaneous (s.c.)     interferon beta-1a 44 µg (Rebif) 3 times weekly. The subjects will be divided into 2 groups,     one receiving cholecalciferol 100,000 IU twice monthly along with Rebif treatment and the     other group will be on placebo along with Rebif treatment. A total of 200 subjects will be     recruited in 20-30 centres in France.   "
159332|NCT01198119|"     This study evaluates the feasibility of the NBI technique in the detection of early cancer     lesions.   "
159418|NCT01196975|"     This study is designed to test the immunogenicity and safety of an investigational influenza     vaccine, in adults compared to two other influenza vaccines.      This study will also evaluate the lot-to-lot consistency of three vaccine lots.   "
159333|NCT01198106|"     BACKGROUND:flight simulator have become an important component in pilot training. However,     they are known to be associated with motion sickness like symptoms defined as Simulator     Sickness (SS). Prevention countermeasures against motion sickness have been studied     extensively focusing on cholinergic blockers and antihistamines. Most comparataive studies     emphasized the effectiveness of scopolamine over outher agents. Evidence, though, on     prophylaxis against SS is sparse.      OBJECTIVE: to assess the effectiveness of oral scopolamine versus oral cinnarizine or placebo     for SS prevention in helicopter pilots.      DESIGN: a prospective, placebo controlled double-blind.      SETTING: Israel Air Forse (IAF) Helicopter Aircaft vWeapon System Trainer.      PARTICIPANTS: IAF experienced helicopter pilots.      INTERVENTION: 0.6 mg oral scopolamine or 50 mg oral cinnarizine or placebo 1 hour before     beginning of a 3 sortie simulator training   "
159334|NCT01198093|"     The objective of this study is to present evidence-based medicine for development of clinical     practice guideline through prospective study of Alzheimer's disease(AD) and mild cognitive     impairment(MCI) in korea   "
159335|NCT01198080|"     Avascular necrosis is a disease where there is cellular death (necrosis) of bone components     due to interruption of the blood supply. Without blood, the bone tissue dies and the bone     collapses. If avascular necrosis involves the bones of a joint, it often leads to destruction     of the joint articular surfaces. Avascular necrosis is especially common in the hip joint. A     variety of methods are now used to treat avascular necrosis the most common being the total     hip replacement, or THR.A new, more promising treatment is hip resurfacing or metal on metal     (MOM) resurfacing.Another treatment is utilization of bone marrow derived stem cells.these     stem cells can provide angiogenic factors and osteogenic cytokine to improve angiogenesis and     bone formation.   "
159336|NCT01198067|"     The goal of this clinical research study is to find the highest tolerable dose of     pomalidomide that can be given to patients with relapsed or refractory WM. The safety of this     drug will also be studied.   "
159337|NCT01198054|"     The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in     patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5     (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for     those who no obtained response treatment (total resistance) or partial remission.      At the same time, the study evaluate the security of lenalidomide.   "
159338|NCT01198028|"     The goal of this clinical research study is to learn if erlotinib can help to control     squamous cell carcinoma that has either come back or has spread. The safety of this drug will     also be studied.   "
159339|NCT01198015|"     Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good     appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The     pathological mechanism is barely understood. Although feeding difficulties may play a role in     this, other constitutional factors as altered metabolic processes are suspected. Preliminary     research showed elevated plasma creatine concentrations and increased urinary     creatine/creatinine ratios in half of the RTT girls.      The aim of this study is to confirm previous findings and examine the functionality of the     creatine transporter in RTT girls.      The investigators assume that previous findings will be confirmed, and are due to an altered     functionality of the creatine transporter.   "
159340|NCT01198002|"     The primary purpose of this study is to help answer if LY2127399 is safe and effective in the     treatment of rheumatoid arthritis while on a background treatment of methotrexate.      This study is comprised of 3 periods:      Period 1 - 52 week blinded treatment      Period 2 - additional 48 week unblinded treatment      Period 3 - 48 week post treatment follow up   "
159341|NCT01197989|"     The purpose of this study is to evaluate the efficacy of a special sock, manufactured using     TEPSO®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar     pustulosis present for at least one year.   "
159342|NCT01197976|"     The purpose of this study is to evaluate the efficacy of a special sock, manufactured using     TEPSO®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar     psoriasis present for at least one year.   "
159343|NCT01197963|"     The purpose of the study is to determine if by performing surgery we can cure Type II     Diabetes.      The surgical procedures:        1. a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction          of caloric intake and rapid gastric emptying.        2. ileal transposition which involves repositioning a 150cm segment of the ileum into the          jejunum causing improved glucose homeostasis.   "
159344|NCT01197950|"     The purpose of this study is to evaluate the effect of manual acupuncture and     electro-acupuncture on labour pain.   "
159345|NCT01197937|"     The goal of this observational study is to assess the efficacy of Realize My Success (RMS),a     website that allows patients and providers to maintain contact via the website. We will     compare RMS users on a number of different variables with the goal of identifying which     variables are associated with optimal outcomes (larger weight losses) at one year (and     potentially beyond). The study has two primary objectives. The first is to assess changes in     body weight at postoperative year 1 in frequent v. infrequent RMS users. We predict that     frequent users will achieve significantly greater reductions in weight at 6 and 12 months     (and beyond) than infrequent users. The second objective is to assess changes in body weight     at postoperative year 1 in persons who use different features of the RMS site. We hypothesize     that persons who, on a regular basis, record their food intake, track their physical activity     and make specific behavioral goals will experience significantly greater reductions in weight     beginning 6 months after surgery as compared to those who do not use these features of the     RMS site.   "
159360|NCT01197729|"     OPTAMI documents the characteristics of consecutive patients with acute STEMI and NSTEMI in     hospital everyday-life in Germany, their acute and adjuvant medication treatment, events     until discharge (e.g. mortality, stroke, re-MI), and their medication for secondary     prevention at discharge.      In the follow up-period of one year, information is collected concerning events as mortality,     stroke, re-MI, coronary interventions (PCI, CABG) and re-hospitalisation.      The implementation of guideline-adjusted therapy in hospital everyday-life is reviewed. The     usefulness of the European standard for data acquisition in cardiology (CARDS = Cardiology     Audit and Registration Standards) is evaluated.   "
172726|NCT00094198|"     To assess interactions between selected cardiovascular medications and genes in the incidence     of heart attack, stroke, and atrial fibrillation, an irregular heartbeat.   "
159346|NCT01197924|"     The medulloblastome is a tumour of the child relatively frequent usually sitting in the     cerebellum and treated by surgery, radiotherapy and chemotherapy. After the treatment, these     children present cognitive disorders and in particular disorders of the working memory     associated with a fall with the school performances. By studying a troop of 32 children, we     could show that the disorders of the working memory prevail during the handling of     information presented visually and with verbal contents. However, the specific engagement of     the cerebellum in the tasks of working memory according to the sensory method of presentation     (visual or auditive) and the nature (verbal or not verbal) of information to treat vague     remainder. Moreover, the anatomical attacks associated with these disorders remain ignored in     these children. The best comprehension of the bases anatomo-functional calculuses which     underlie their cognitive deficits is essential to develop new strategies of treatment and     rehabilitation.      Objectives:        -  To describe in IRMf of the common and specific networks engaged during the execution of          the tasks of working memory according to the sensory type and the nature of information          to be memorized.        -  To describe in IRMf the cortical reorganizations necessary to the execution of the          mnemic tasks among patients.        -  To describe in anatomical IRM and of the tensor of diffusion lesions cérébelleuses and          cerebral, cortical and subcortical associated with these disorders.        -  To study the correlations radio-private clinics between data IRM and the data          neurological and neuropsychological of the children explored according to protocol          ONCORAP   "
159347|NCT01197911|"     This open-label study will assess the effects of hepatic impairment on the pharmacokinetics     of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment     (Child-Pugh class A or B) and in matched control subjects with normal hepatic function.     Subjects will receive a single oral dose of aleglitazar, with assessment of the     pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled     subject is approximately 6 weeks.   "
159348|NCT01197898|"     The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds     following 14 days of treatment with Santyl or its vehicle base.   "
159349|NCT01197885|"     IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma.     Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect     (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct     mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is to     establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients     suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower     esophagus.   "
159350|NCT01197872|"     Gene Security Network has developed a novel technology called Parental Support (PS) which is     used for Preimplantation Genetic Screening/Diagnosis (PGS/D) during in vitro fertilization     (IVF). This technology allows IVF physicians to identify embryos, prior to transfer to the     uterus, which have the best chance of developing into healthy children.   "
159351|NCT01197846|"     Pilot multicentric, prospective, placebo controlled, randomized double blinded, study of 12     weeks follow-up Adult patients diagnosed of bipolar disorder I or II, in previous treatment     with no more than two concomitant mood stabilizers at stable doses and current subsyndromal     symptoms, defined as YMRS ≤14 and/ or MADRS≥8 and ≤14 would be included Sub-acute phases     would be excluded (at least 8 weeks from last exacerbation would be required for inclusion).   "
159352|NCT01197833|"     Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and     may cause discomfort. In this study, patients with varicose veins in the legs will be     participating. The purpose of this research study is to evaluate the safety and effectiveness     of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM)     compared to vehicle (inactive solution) when used following an approved heat treatment in     subjects with varicose veins.   "
159353|NCT01197820|"     Several technological challenges exist to apply Magnetic Resonance guided High Intensity     Focused Ultrasound (MRgHIFU) for treatment of liver or kidney in particular challenges     related to the motion of these organs. This study tests a new software to improve thermometry     accuracy in mobile organs in patients with liver or kidney tumors. In the same time, the     trajectory of the target in 3D is analyzed.   "
159354|NCT01197807|"     Until recently, bulb or catheter oronasopharyngeal suctioning (ONPS) of all the infants,     including vigorous infants in the delivery room, has been featured as a standard of newborn     care. The 5th edition of the Newborn Resuscitation Program (NRP) has minimized the     recommendation for routine suctioning of infants following delivery, provided they are not     depressed or in need of immediate resuscitation. However, this new alternative recommendation     was based on a small randomized trial and other lower level evidence rather than evidence     from larger trials. The NRP Textbook cautions against vigorous suctioning because of the     resultant apnea or bradycardia. Furthermore, suctioning may delay other more important steps     of resuscitation. Thus, it is necessary to compare the alternative recommended practice, i.e.     simple wiping of the mouth, to determine if it has equivalent efficacy and a favorable side     effect profile compared to suctioning.   "
159355|NCT01197794|"     The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active     compound in asthmatic patients.   "
159356|NCT01197781|"     This Study evaluates the possible drug interaction between FosD and verapamil when taken     together.   "
159357|NCT01197768|"     The purpose of this study is to evaluate the efficacy and feasibility of a multi-level     self-management intervention to improve nutritional intake in a group of homebound older     adults (HOAs) who are at especially high risk for undernutrition. The study will be guided by     the theoretical approaches of the Ecological Model and Social Cognitive Theory and will use a     prospective randomized controlled design to estimate whether individually tailored counseling     focusing on social and behavioral aspects of eating results in increased caloric intake and     improved nutrition-related health outcomes in a sample of 104 HOAs. The investigators     hypothesize that intervention at these levels will improve caloric intake and indirectly     improve health outcomes.   "
159358|NCT01197755|"     The purpose of the study is to evaluate the effectiveness of two dosing regimens of     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking     methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study     will last for approximately six months.   "
159364|NCT01197677|"     1. The main aim of the first specific protocol initiated by the European CMR registry,          suspected CAD, is to demonstrate that patients presenting for work up of suspected          coronary artery disease, which have a completely normal CMR scan will have a low risk          for cardiovascular events.        2. The main aim of the second specific protocol initiated by the European CMR registry,          HCM-SCD, will be to evaluate CMR for risk stratification in hypertrophic          cardiomyopathy(HCM).        3. This registry is sought to collect data on the general use of CMR in the European          clinical practice, its safety and its therapeutic implications in a high number of cases          to 1) substantiate the clinical yield of CMR and 2) to define additional clinical          questions worth to be investigated in detail as additional specific protocols in the          future.   "
159365|NCT01197664|"     This randomized pilot clinical trial studies the side effects of giving paricalcitol together     with fluorouracil and radiation therapy in treating patients with rectal cancer that can be     removed in surgery. Paricalcitol may help rectal cancer cells become more like normal cells,     and to grow and spread more slowly. Drugs used in chemotherapy, such as fluorouracil, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. It not yet     known if chemotherapy and radiation therapy are more effective with or without paricalcitol     in treating rectal cancer   "
159366|NCT01197651|"     The aims of the aorta-stent-Registry are:      • participating hospitals (with audit) document all consecutive patients diagnosed with a     disease of the distal thoracal aorta that receive one of the following therapies:   "
159367|NCT01197638|"     The goal of this register is the documentation of the success as well as of the complications     regarding interventional therapy of cardiac arrhythmia by catheter ablation. This is the     necessary basis for quality management and development of possible improvements of catheter     ablation.   "
159368|NCT01197625|"     In this study the investigators will include patients with high risk of PSA relapse scheduled     to receive curative surgical treatment. This include patients with high Gleason score (9-10)     or micrometastatic disease (tumor cells detected in specimens obtained from bone marrow).     They are scheduled for regular follow-ups with PSA measurements. We have previously published     that some patients with metastatic prostate cancer may respond to DC-vaccination with tumor     mRNA, with a decrease in PSA. PSA response is related to immunological response. Patients     receiving DC-vaccination may have a reduced risk of PSA relapse or increased time to PSA     relapse. Previous experience with different DC-vaccine protocols in our hospital has resulted     in only minor side-effects (grade 1-2 fever, rubor, fatigue, local swelling or pain).   "
159369|NCT01197612|"     That high-dose steroid applied to the nasal cavity immediately post-operatively will improve     olfaction and healing following endoscopic sinus surgery.   "
159370|NCT01197599|"     The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit     training on the upper extremity of persons with spinal cord injury and able-bodied controls.   "
159399|NCT01197222|"     Virtual Ports, Ltd., has developed a lens cleaning device, EndoClear, which is attached to     the internal abdominal wall at the beginning of a surgical case and remains in position until     completion of the surgery, enabling the surgeon to clean the camera lens without removing it     from the abdominal cavity. The purpose of this study is to evaluate the efficacy and safety     of using the EndoClear device as a laparoscopic lens cleaning device.   "
159371|NCT01197586|"     Establishing new biochemical markers in the differential diagnostics and risk stratification     in heterogeneous patient collectives is becoming more and more important. The markers should     be objective, reliable, reproducible, quick and cost effective as well as specific and     sensitive. Concerning the differential diagnostics of dyspnea, NT-pro-BNP plays the most     important role for the evaluation of a cardiac origin. However, a corresponding biochemical     marker for pulmonary stress is lacking. The aim of the study at hand therefore was the     evaluation of surfactant protein B in the differential diagnostics of pulmonary and cardiac     diseases.   "
159372|NCT01197573|"     We hypothesize that delayed graft function and ITBS events may be related to small blood     clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of     the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant     morbidity and mortality, and may ultimately result in a greater number of transplantable     livers and kidneys.   "
159373|NCT01197560|"     The purpose of this study is to compare lenalidomide to a control drug and see which one     delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.   "
159374|NCT01197547|"     This is a clinical registry of an FDA approved device system called the Genesys Hydro     ThermAblatorTM (HTA) system (Boston Scientific). The HTA system's intended use is to be     inserted, by a trained physician, into the uterus, where it will fill and circulate fluid     that is warm enough to change the characteristics of the uterine lining. This is done with     the anticipated result of improving menstrual bleeding symptoms.      The purpose of this FDA-mandated registry is to obtain clinical experience on the use the     Genesys HTA™ system, under normal clinical conditions, and document its safety and technical     reliability.   "
159375|NCT01197534|"     The purpose of the study is to evaluate the effectiveness of two dosing regimens of     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking     disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1     year.   "
159376|NCT01197521|"     The purpose of the study is to evaluate the effectiveness of two dosing regimens of     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking     methotrexate but not responding. The study will last for 1 year.   "
159377|NCT01197508|"     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a     medicine tablet or capsule, but contains no active medicine) is safe and effective when taken     together with another antidepressant.   "
159378|NCT01197495|"     The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra     XC Injectable Gel for lip augmentation   "
159753|NCT01192516|"     The primary objective of this project is to examine effectiveness of a tailored pacing     intervention on fatigue, pain, and physical function compared to general pacing intervention     and usual care groups. A secondary objective is to evaluate the natural history of symptoms     and physical disability over time among people with knee and hip osteoarthritis.   "
159379|NCT01197482|"     Investigational device: AKITA 2 device versus conventional metered-dose inhaler (MDI)      Objectives: To explore if inhalative fluticasone application by means of the AKITA technology     would result in a better symptom control in patients with severe persistent asthma as     compared to inhalative application of fluticasone by a conventional MDI.      Study design: open label, cross-over (one AKITA, one MDI arm)      Patients: 20 Patients with severe persistent asthma   "
159380|NCT01197469|"     The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise     capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary     hypertension.   "
159381|NCT01197456|"     More than two million American women are breast cancer survivors. Approximately one-third of     these women are premenopausal at diagnosis and face issues related to reproduction as they     undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on     breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire     for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian     function in breast cancer survivors could significantly impact physicians and patients in     counseling, medical and surgical treatment choices, and consideration of fertility     preservation options.      The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian     imaging markers that can predict ovarian failure and characterize the course of ovarian     function after chemotherapy. The investigators plan to follow a group of young women from     breast cancer diagnosis to five years after chemotherapy. The investigators will study the     following risk factors: blood hormone levels that reflect ovarian function, genetic mutations     that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI     and ultrasound. The investigators hypothesize that these biomarkers are related to risk of     ovarian insufficiency singly. After examining these individual risk factors for ovarian     failure, the investigators will put them together into an Ovarian Failure Clinical Predictive     Index. This index will be a tool similar to the Gail Model that can be used to determine     individual risk for ovarian failure. This tool would assist young breast cancer patients and     their physicians in making treatment decisions that would impact cancer survival and     reproduction.   "
159382|NCT01197443|"     The overall intent of this study is to explore a promising mode for delivering treatment for     childhood obesity via parent education only, and to evaluate the cost effectiveness compared     to the current gold standard treatment of parent-and-child dual education.   "
159383|NCT01197430|"     Purpose: Optimal eye-hand coordination is important for volleyball players. Neck disorder may     affect neck function and subsequently eye-hand coordination. The purpose of this study is to     explore the vertical stability training effects on coordination of the upper extremities of     female volleyball players.      Methods: This study surveyed 25 players of a volleyball team, randomly assigned into the     group A (training 1st) and group B (training 2nd). The group A includes 13 volleyball players     and the group B includes 12. Eye-hand coordination was tested by a self-developed     hand-stroking table device and stay time and motion time of upper extremities were     determined. There are two testing modes, regular and random. Motion time for the electric     probe moving between target sensor and stay time for the electric probe staying on a target     sensors were collected for each mode, before each session of training and after the end of     the 2nd session. In the 1st session of training, group A started vertical stability training     and group B did control training for six weeks. In the 2nd session of training, the training     programs were shifted between group A and B for another six weeks.   "
159384|NCT01197417|"     The purpose of this study is to determine the safety and efficacy of intravenous magnesium in     shortening the duration of a pain crisis and to determine the health-related quality of life     and short term outcomes of children treated with intravenous magnesium during an acute pain     crisis.   "
159385|NCT01197404|"     Adolescents are at risk for HIV because of sexual and drug use behavior initiated during     early adolescence, and those with mental health problems appear to be particularly     susceptible. Problems with managing emotions may make it difficult for early adolescents to     make good decisions about sexual and substance use behaviors. This project will develop and     evaluate interventions for early adolescents with mental health issues. An intervention     focused on teaching affect management skills will be compared to an intervention addressing a     variety of health topics to determine which intervention best reduces risk behavior among     this at-risk population.   "
159386|NCT01197391|"     This study will test the safety and tolerability (how the body reacts to the drug) of REGN728     compared with placebo (an inactive substance that contains no medicine) in healthy subjects.     The study drug and placebo will be administered by subcutaneous injection (under the skin) at     the clinic visit. There will be 14 clinic visits, which will include 4 overnight stays.     Subjects will be monitored by the study staff for side effects and the body's response to the     study drug. Vital signs (blood pressure, temperature, breathing and heart rate) will be     checked, blood and urine samples will be collected at some or all visits.   "
159387|NCT01197378|"     Cystinosis is an inherited disease that if untreated, results in kidney failure as early as     the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate)     which must be taken every six hours for the rest of the patient's life to prevent     complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being     studied to see if it may be able to be given less frequently, once every 12 hours, and have     similar results to four times a day Cystagon®.   "
159388|NCT01197365|"     The purpose of this study is to determine the safety and efficacy of an infant formula     supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in     improving the gastrointestinal health and immune response in healthy term infants.   "
159389|NCT01197352|"     Young adults are in a critical period where they can be influenced to avoid a trajectory of     high-risk drinking and harmful outcomes in the later adult years. The Emergency Department     might offer a unique opportunity to reach young adults, if an easy to implement screening,     brief intervention and referral to treatment was available. The investigators are     investigating the feasibility and accuracy of ED-initiated and outpatient-continued     assessment of drinking behavior in young adults using a computer-driven text messaging     platform. Based on the subject's response to weekly assessments, the computer platform will     send personalized motivational messages in real-time.   "
159754|NCT01192503|"     The purpose of this study is to find out if rasagiline improves RLS symptoms. We also want to     make sure rasagiline is safe to give people with RLS.   "
159390|NCT01197339|"     The purpose of this study is to generate a technology that will allow clinicians to prescribe     behavioral treatment that should optimize tissue healing for both acute and chronic     phonotrauma. In this study, we propose to (1): establish a non-invasive methodology for     estimating overall mechanical dose during phonation, and component metrics of phonatory     mechanical dose (e.g., distance dose, energy dissipation dose and time dose) from high speed     imaging data and aeromechanical modeling, for a range of vocal fold configurations     (Experiment 1); (2): identify mathematical relations between treatment dose parameters,     inflammatory state of the tissue and time-varying biological consequences in the tissue, up     to 2 wk following acute phonotrauma (Experiment 2); (3): develop a hybrid physical-biological     model of vocal fold inflammation and treatment to identify treatment modalities that should     optimize post-traumatic wound healing at 2 wk, for a range of acute phonotraumatic conditions     (Experiment 3—no human subject involved), and (4): provide a preliminary test of the hybrid     treatment models' ability to predict idealized treatment outcome in human subjects, and     calibrate the model as needed iteratively to achieve a match between predicted and obtained     outcomes (Experiment 4).   "
159391|NCT01197326|"     The purpose of this study is to assess if, compared with standard paper-based systems, an     automated Early Warning System (EWS) resident in a spot check patient monitor, can help to     identify deteriorating patients.   "
159392|NCT01197313|"     Anxiety and depression are often present in patients with chronic heart failure (CHF). This     study aimed to evaluate the influence of anxiety and depression on the physical function,     disability, and quality of life (QOL) in CHF. This study examined the effects of 8-week     home-based exercise on these parameters, and investigated the correlations between these     outcome changes.   "
159393|NCT01197300|"     This 1-year open-label extension to CZOL446H2337 is designed to evaluate the safety and     efficacy of zoledronic acid twice yearly in osteoporotic children treated with     glucocorticoids.   "
159394|NCT01197287|"     There are three elements to this study:        -  Part A: Single dose escalation in healthy subjects. 6 dose levels of QAK423 are planned          in healthy volunteers.        -  Part B: Single dose escalation in patients with mild/moderate COPD. 3 dose levels of          QAK423 are planned in COPD patients.        -  Part C: Titrated repeat dosing for a maximum of 14 days in mild/moderate COPD patients.      Repeat dosing is planned in COPD patients.   "
159395|NCT01197274|"     The purpose of this study is to compare the results skin prick tests using simple blood     lancet (Vitrex®) with DuoTips among mite-sensitized subjects.   "
159396|NCT01197261|"     The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects     suffering from severe pain due to Bladder Pain Syndrome.   "
159397|NCT01197248|"     Up to 50% of patients undergoing pelvic floor repair experience short-term postoperative     voiding dysfunction, increasing the length of hospitalization, cost and anxiety among     patients.      The mechanism behind this problem is the sutures placed in the pubocervical fascia during the     cystocele repair. The cited benefit of bladder plication is greater cure of cystocele. The     existence of pubocervical fascia and the need for placement of plicating sutures over the     bladder have been questioned.      The objective of this study is to determine if avoiding cystocele plication in women     undergoing surgery for cystocele decreases the need of catheterization beyond post operative     day #2.      We will conduct a RCT of patients undergoing transvaginal repair of midline cystocele at the     Mount Sinai Hospital. Patients will be randomized to receiving plicating sutures versus no     plication. This procedure may be conducted with or without concomitant correction of other     sites of prolapse. However, they will not have any procedures for correction of stress     incontinence.      This study will be powered to detect a reduction in voiding dysfunction from 50% to 25% of     patients. Using a χ2 distribution, and an alpha error of 0.05, the required sample size is 58     patients per group.   "
159400|NCT01197209|"     This is a phase I neoadjuvant gene therapy followed by prostatectomy, open-label,     dose-escalation trial for prostate cancer patients with high risk of local recurrence after     radical prostatectomy. Patients entered into this trial will have Prostate Cancer of Clinical     stage T1c, T2 or T3 with a Gleason Score of between 7 (4+3) and 10 at the time of enrollment.     Patients will receive three 1 mL injections (3 mL total volume) of Ad-REIC/Dkk-3 into the     prostate prior to undergoing a radical prostatectomy. Three patients will be treated at each     dose level unless a dose-limiting toxicity (DLT) is observed or MFD (defined as 1 x 10e12     vp/treatment) is achieved with expansion for up to 6 more patients at the MTD or MFD.   "
159401|NCT01197196|"     This study involves a randomized controlled trial to test the efficacy of behavioral weight     loss as a treatment for migraine in obese females aged 18 to 50 years. The primary aim is to     examine whether participants assigned to a behavioral weight loss treatment condition report     greater pre- to post-treatment reductions in migraine headache frequency than participants     assigned to a migraine education condition.   "
159402|NCT01197183|"     This observational survey with prospective and/or retrospective follow-up is designed to     study practices for the initial treatment of hypothyroidism in France without modifying     subject treatment.   "
159403|NCT01197170|"     The goal of this clinical research study to find the highest tolerated dose of anastrozole     alone or in combination with either everolimus (Afinitor), sorafenib (Nexavar), erlotinib     (Tarceva), fulvestrant (Faslodex), or bevacizumab (Avastin) that can be given to patients     with advanced cancer. The safety of these drug combinations will also be studied.   "
159419|NCT01196962|"     There is no randomized controlled trial to compare the rates of complications associated with     internal jugular and subclavian venous catheterization. The aim of this study is to compare     mechanical, infectious, and thrombotic complications of internal jugular and subclavian     venous catheterization. An improved understanding of CVC-related risks might help clinicians     to choose one approach over the other in specific clinical settings.   "
159481|NCT01196156|"     This non-interventional study for prospective follow up of a cohort of 220 subjects born     small for gestational age (SGA) is planned for the purpose of finding out if normalisation of     adult height is associated or not with metabolic alterations and if true, their magnitude and     relevance as well as to detect warnings throughout the treatment period that may be useful     for prevention or therapy. This study would help in answering the question if the SGA and     growth hormone (GH) association results in insulin resistance and if affirmative, who     develops it as well as its impact on other metabolic parameters that precedes type 2     diabetes.   "
159404|NCT01197157|"     The main objective of antiviral therapy of patients with chronic hepatitis C (CHC) is the     sustained elimination of the hepatitis C virus (HCV). The standard of care (SOC) is     peginterferon alfa-2a/-2b with ribavirin for 48 weeks or 24 weeks according to HCV genotype.      However, this approach is not sufficient to substantially improve the sustained virologic     response (SVR) rates. Therefore, new therapies are needed to treat patients with hepatitis C     virus (HCV) infection. Nitazoxanide (NTZ), originally used to treat cryptosporidium parvum     infection, recently was shown to have an unexpected antiviral activity in the HCV replicon     system and in chronically infected patients.      The aim of this work is to study impact of nitazoxanide therapy in addition to     peginterferon/ribavirin combination on virologic responses in patients with chronic hepatitis     C genotype 4.      Patients will be enrolled in this study and will be randomly assigned in a 1:1 ratio into 2     groups:      Group A: comprises 100 CHC patients who will receive the standard of care treatment,     peginterferon-alf 2a plus weight-based ribavirin for 48 weeks.      Group B: comprises 100 CHC patients who will receive nitazoxanide monotherapy at a dose of     500 mg twice daily for 12 weeks as a lead-in phase followed by triple therapy, nitazoxanide     500 mg twice daily plus peginterferon alfa-2a, and weight-based ribavirin for 48 weeks.      Data will be collected and statistical analysis will be done comparing the groups regarding     response to antiviral therapy. Final results will be discussed and compared to similar     studies published in peer reviewed journals and international conferences.   "
159405|NCT01197144|"     The purpose of this study is to obtain increased knowledge concerning central pain and     fatigue processing in rheumatoid arthritis, and how these conditions are influenced by     treatment with Tumor Necrosis Factor (TNF) blockade with adalimumab.   "
159406|NCT01197131|"     Deviation of hormone formation within nerve cells and nerve system provides autism spectrum     disorder and neurodevelopment retardation through interaction of steroids with     neurotransmitter-receptors, calcium-channel receptors and genomic interaction via nuclear     steroid receptors.      Urinary steroid metabolites will be compared between children with autism spectrum disorder     and healthy controls.   "
159407|NCT01197118|"     Gastric cancer is one of the most prevalent malignancies in China; the survival rate remains     poor despite potentially curative resections. Complete surgical resection is the only     potentially curative therapy available to patients with gastric cancer. However, even after a     complete resection with negative margins, many patients will experience recurrence. In recent     years, the radiation therapy in the carcinoma of the stomach represents a new issue that     should be addressed accompanying the development of radial physics and radial biology, the     clinical application of computed tomographic (CT) simulation and digital reconstitution     technique, especially the application of 3-dimensional conformal and intensity modulated     radiation therapy. Radiation therapy plus concurrent chemotherapy has been demonstrated to     cause a significant improvement in overall and disease-free survival according to Intergroup     Trial 0116/SWOG 9008. So the investigators designed the trial to see whether a postoperative     sequence chemoradiotherapy including oxaliplatin fluorouracil-based regimen can improve     survival for advanced gastric cancer.   "
159408|NCT01197105|"     The purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a     natural product (Schinus terebinthifolius) used by children with gingivitis.   "
159409|NCT01197092|"     A treatment with the concept of mitochondrial medication developed by Dr Heinrich Kremer can     demonstrably improve and successfully treat actual parameters of Diabetes Mellitus II as well     as its risk factors.   "
159410|NCT01197079|"     The objectives of this study are:        1. to determine the degree of understanding and perceived risks for human papillomavirus          (HPV) disease, to examine and assess attitudes for personal use of HPV vaccine and          identify potential barriers to HPV vaccine access and utilization in a population of          young men who have sex with men (MSM) (under 26 years of age)and in parents of boys aged          9 to 18 years        2. to determine HPV vaccine acceptance and predictors of acceptance in a population of          young MSM and in patients of boys ages 9 to 18 years        3. to develop strategies to overcome potential barriers to vaccination and improve vaccine          access and utilization via development of targeted educational initiatives.   "
159411|NCT01197066|"     This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and efficacy     of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with     active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.   "
159412|NCT01197053|"     This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and     efficacious for desensitizing children with peanut allergy.   "
160892|NCT00000332|"     The purpose of this study is to determine if nimodipine is more effective than placebo in     reducing stimulated craving for cocaine in cocaine dependent individuals denied access to     cocaine in inpatient unit.   "
159413|NCT01197040|"     A multicenter, randomized, study will be performed to evaluate the efficacy of low dose     steroid combined with mycophenolic acid (MyforticR) versus high dose steroid in inducing     remission in adults with minimal change nephrotic syndrome (MCNS). One hundred and fourteen     patients (CPP decision 2009-04-02-a5) will be included in this study. They will be randomly     assigned to an open label treatment with either prednisone      1 mg/kg/day (arm A) or 0,5 mg/kg/day plus myforticR 1440 mg/day (arm B) for four weeks. The     outcome will be compared during one-year follow up   "
159414|NCT01197027|"     The purpose of this study is to evaluate the acceptability and feasibility of an enhanced,     individual-level counseling intervention for individuals in the acute and early phase of HIV     infection aimed at reducing risk behaviors.   "
159415|NCT01197014|"     Study Design :      - A single center, open, randomized, single dose, two-period, two-treatment, two-sequence,     crossover study   "
159416|NCT01197001|"     Study Design :        -  A single center, open, randomized, single dose, two-period, two-treatment, two-sequence,          crossover study      Primary Objective:        -  To assess the bioequivalence of combination oral formulation of amlodipine/losartan          versus two co-administered products containing amlodipine and losartan   "
159417|NCT01196988|"     This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK)     Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to     describe safety and immunogenicity of the GSK Biologicals' investigational vaccine     GSK2321138A in children aged 6 to 35 months.   "
159420|NCT01196949|"     It is hypothesized that a combination approach would produce increased clinically and     statistically significant outcomes as opposed to standard single intervention, inclusive of     comparatively greater reduction in pain, improvement in range of motion, proprioception and     function with an associated quicker recovery time.      Chronic ankle instability (CAI) is a frequently encountered condition of the musculoskeletal     system. Various individual treatment options have previously been compared to one another in     clinical trials, however there is paucity of literature with regards to combined treatment     choices versus individual therapy. The purpose of this study is to investigate the relative     effectiveness of combined manipulation and rehabilitation versus rehabilitation only, in the     management of CAI.      The study will be conducted as a single blinded randomised and comparative clinical trial at     Cleveland Chiropractic College and Durban University of Technology.   "
159421|NCT01196936|"     Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate     may fight breast cancer by blocking the use of estrogen by the tumor cells      This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast     cancer risk in radiation-induced cancer survivors.   "
159422|NCT01196923|"     The purpose of this study is to confirm the safety and effectiveness of the CardioFocus     Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.   "
159423|NCT01196910|"     The aim of the study is to assess the effect of left or right high-frequency DTMS on ADHD     symptoms, cognitive performance and decision-making ability of ADHD adults, and to compare     this to the effect of sham DTMS on ADHD adults   "
159424|NCT01196897|"     This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure     Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2     stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study     to evaluate the initial use of the next generation WATCHMAN Device.   "
159425|NCT01196884|"     Primary ITP has wide heterogenous biology, presentation and response to therapy.      The immune-genetic assessment of ITP may help to identify differences among patients with ITP     and optimize the therapeutic choice.   "
159426|NCT01196871|"     The purpose of this study is to determine the effects of AT1001 on the safety of agalsidase,     and the effects of agalsidase on the safety of AT1001.   "
159427|NCT01196858|"     During the 1990s, evidence began to emerge of the long duration of untreated illness prior to     receiving treatment for patients with psychotic disorders. Studies across the world on first     episode psychosis have consistently found an average of 1 - 2 years between the onset of     psychotic symptoms and the start of treatment. Lengthy treatment delay has immediate     implications such as unnecessary distress for patients and families, and may also compromise     potential recovery when treatment is initiated.By understanding how and why substantial     delays occur the investigators may be able to better design interventions to facilitate     better earlier treatment. The components of DUP can be conceptualised as comprising 3     distinct intervals: help-seeking delay, referral delay and delay in mental health services.     In this study the primary aim is to establish the level of DUP in nordland, and explore the     components of this variable. Help-seeking delay will be investigated by interviewing patients     presenting at the central mental health hospital in Nordland about their psychosis onset and     pathways to care. Referral delay will be investigated by a questionnaire about the referral     pratices among GPs in Nordland. Delays in mental health services will be investigated by     focus group interviews with leaders and professionals at the 7 community mental health     centers in Nordland. This knowledge is believed to be crucial for developing services that     can reduce DUP and give this patient population earlier access to adequate treatment.   "
159428|NCT01196845|"     The main objective of this study is to evaluate the decrease of inflammation of adipose     tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by     continuous positive airway pressure (cPAP).      An interim analysis will be performed when 40 patients will be included.   "
159443|NCT01196650|"     This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients     with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will     compare 2 formulations of the IN 10 003 to placebo   "
159429|NCT01196832|"     Chronic obstructive pulmonary disease (COPD) is a frequent airway disease characterized by     both bronchial inflammation and remodelling.      Bronchial mucosa is infiltrated by macrophages, neutrophils and lymphocytes. In addition, the     number of eosinophils can be also increased during exacerbation.      Airway remodelling is an abnormal tissue repair following bronchial inflammation, which     contributes to none reversible pathological features, such as bronchial and peri-bronchial     fibrosis. It also influences the prognosis of COPD and its mechanisms remain largely unknown.     The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis     or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement     in COPD airway remodelling remain unknown.   "
159430|NCT01196819|"     The purpose of this randomized study is to evaluate new generation of MicroPort's DES of its     safety, efficacy and delivery system in treating CAD.      The end point is to observe in-stent late lumen loss after 9 months of the stent     implantation. The second end point is to study in-stent percent diameter stenosis.      This study is based on non-inferior assumption (vs. Xience V DES), requiring both end points     reach statistical significance.      Prespecified OCT follow-up is planned at 3-Year after index PCI at 3 chosen hospitals.   "
159431|NCT01196806|"     The purpose of this study is to compare Measurements of Arterial Blood Pressure by L&T NIBP     Module With Invasive Arterial Blood Pressure in Neonates.   "
159482|NCT01196143|"     This is a phase IV non-interventional, multicentric observational study to evaluate the     baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count     (AFC) and age as prognostic factors of the outcome of the in-vitro     fertilisation/intracytosolic sperm injection (IVF/ICSI) in infertile subjects receiving     Gonal-f for controlled ovarian hyperstimulation (COH).   "
159483|NCT01196130|"     The goal of this clinical research study is to test for biomarkers in patients with     metastatic or unresectable, locally advanced colorectal cancer. Biomarkers are chemical     markers in the tumor tissue and/or blood that may be related to your reaction to cancer     drugs.   "
173557|NCT00115596|"     This study is randomized trial of a procedural skills training curriculum utilizing     simulation to teach basic procedural skills to pediatric residents.   "
159432|NCT01196793|"     A significant number of children 0 to 5 years of age are seen in paediatric Accident &     Emergency departments (A&E) with feverish illness. Most of these patients could safely be     managed in a primary care setting, particularly with guidelines in place on how to optimally     assess these children. Some patients, however, will require admission, either because of a     potentially serious underlying disease or because of other factors, for example parental     concern or difficulties in communication because of language barriers. An increase in the     number of children attending A&E departments with feverish illness as well as a rise in the     volume of admissions has been noted over time. To enable an appropriate adaptation of acute     medical services for children an in depth understanding of the assessment and admission     processes is crucial.      This study primarily aims to describe factors associated with hospitalisation of children     aged 3 months to 5 years presenting with fever to an urban paediatric A&E departments by     describing and analysing characteristics both of those patients admitted to hospital and     those managed in the community. To complement this, information on the short-term healthcare     utilization by families attending the emergency department because of feverish illness will     be collected. The study will be carried out in one participating centre in Switzerland and     the United Kingdom, respectively, to enable a head to head comparison of the assessment and     admission practices in two European countries. The resulting data will be used as the basis     for further research in this area and will provide information on how to optimally structure     service provision in acute febrile childhood illness.   "
159433|NCT01196780|"     This observational study will assess the efficacy and safety of MabThera/Rituxan (Rituximab)     in patients with active rheumatoid arthritis who have had an inadequate response or are     intolerant to anti-TNF therapy. Data will be collected from patients initiated on     MabThera/Rituxan therapy according to standard of care in routine clinical practice. For each     patient data will be collected for 92 weeks.   "
159434|NCT01196767|"     This is a prospective double-blinded and randomised study involving patients undergoing     cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr     continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters     inserted at the lateral edges of the sternum will be studied, versus a control group in which     normal saline will be infused in the same conditions.   "
159435|NCT01196754|"     This is a prospective clinical monocentric study in ICU with sedated ventilated patients with     sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of     sevoflurane.   "
159436|NCT01196741|"     The purpose of this study is to investigate whether the addition of the Src inhibitor     saracatinib (AZD0530) to weekly paclitaxel improves efficacy, compared with paclitaxel plus     placebo, in patients with relapsed platinum-resistant ovarian cancer. The trial will also     determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib     should proceed to a phase III trial.   "
159437|NCT01196728|"     The primary objective of this study is to assess the safety and tolerability of the     Glucagon-like peptide-1 (GLP-1) peptide analogue CM3.1-AC100 after single subcutaneous (sc)     doses in patients with T2DM.   "
159438|NCT01196715|"     REGIME is comparing two treatments, with Darbepoetin Alpha (DA) and Filgrastim (Granulocyte     Colony Stimulating Factor, G-CSF), to the standard treatment for Myelodysplastic Syndrome     (MDS).      After giving Informed Consent patients will undergo a number of tests to confirm eligibility.     Once eligibility is confirmed patients will be randomly assigned to one of the three     treatments group: A: Darbepoetin Alpha (DA), B: Darbepoetin Alpha and Filgrastim (DA+G-CSF),     C: Blood transfusion only. Patients will be required to attend the clinic once a month for 24     weeks. After 24 weeks if a patient has reacted favorably to the treatment they may continue     on the treatment regime up to 52 weeks. After week 24 all patients will be required to attend     the clinic twice more, at week 36 and 52.      Patients will be followed for a further 5 years to record loss of response, transformation to     Acute Myeloid Leukaemia and/or Refractory Anemia with Excess Blasts and death.   "
159439|NCT01196702|"     The purpose of this study is to discover if differences in the surface markers of B-cells     (antibody producing cells of the immune system) in Common Variable Immune Deficiency (CVID)     are related to CVID or its complications/treatment (e.g. bronchiectasis, granulomatous     disease, immunoglobulin treatment).      The study hypothesis is that the altered B-cell surface markers are related to CVID, and not     to the complications or treatment of CVID.   "
159440|NCT01196689|"     The purpose of this study is to study pharmacokinetics in adolescents.   "
159441|NCT01196676|"     This is a single ascending dose study to assess the safety, tolerability and pharmacokinetics     of AZD4451.   "
159442|NCT01196663|"     This Clinical study is preformed in order to estimate the performance of the TMS thermometer     and to make a final tuning of the thermometer mathematical algorithm.      Body temperature of men, women and children will be measured using the TMS thermometer.      Each Patient will be measured both with the TMS thermometer and with an esophageal or urinal     thermometer as a reference.   "
159444|NCT01196637|"     Thoracic outlet syndrome is caused by compression of the brachial plexus, in most cases under     the pectoralis minor muscle in the infraclavicular region of the shoulder. The hypothesis is     that ultrasound imaging can be used to visualize brachial plexus compression and distortion     of the pectoralis muscle during arm activity, such as abduction, and that normal subjects     will not demonstrate any plexus compression or muscle distortion.   "
159479|NCT01196182|"     Congenital heart defects (CHD) are the most common major human birth malformation, affecting     ~8 per 1,000 live births. CHD are associated with significant morbidity and mortality, and     are second only to infectious diseases in contributing to the infant mortality rate. Current     understanding of the etiology of pediatric cardiovascular disorders is limited.      The Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) is a multi-center, prospective     observational cohort study. Participants will be recruited from the Pediatric Cardiac     Genomics Consortium's (PCGC) centers of the NHLBI-sponsored Bench to Bassinet (B2B) Program.     Biological specimens will be obtained for genetic analyses, and phenotype data will be     collected by interview and from medical records. State-of-the-art genomic technologies will     be used to identify common genetic causes of CHD and genetic modifiers of clinical outcome.      To accomplish this, the PCGC will develop and maintain a biorepository of specimens (DNA) and     genetic data, along with detailed, phenotypic and clinical outcomes data in order to     investigate relationships between genetic factors and phenotypic and clinical outcomes in     congenital heart disease.   "
159445|NCT01196624|"     Subjects      Forty consecutive patients fulfilling the DSM-IV diagnostic criteria for PTSD will be     recruited from the inpatient and outpatient treatment programs at the Beer Sheva Mental     Health Center. Patients will complet a course of 10 daily rTMS sessions.      After receiving a full explanation of the procedures, all subjects will sign a written     informed consent statement approved by the Helsinki Ethics Committee of Ben-Gurion     University.      Study Design      The study suggested here will recruit 40 patients with DSM-IV PTSD also demonstrating at     least moderately severe flashbacks. Each of the subjects will be recruited randomly to one of     4 groups:        1. Right DLPF Rtms (10Hz) co-administered with neutral visual and/or auditori stimuli;        2. Right DLPF Rtms (10Hz) co-administered with visual and/or auditori traumatic stimuli          mimicking experiences appearing during the patients flashbacks;        3. Left DLPF Rtms (10Hz) co-administered with neutral visual and or auditori stimuli;        4. Left DLPF Rtms (10Hz) co-administered with visual and/or auditori traumatic stimuli          mimicking experiences appearing during the patients flashbacks;      Treatment Characteristics      rTMS will be performed with a Magstim stimulator (Magstim Company, Whitland, U.K.) The motor     threshold was determined in each subject once, before treatment. This was defined as the     lowest stimulation intensity capable of inducing a visible movement at least five times out     of 10 stimulations.      The position of the right dorsolateral prefrontal cortex will be defined as 5 cm anterior (in     a parasagittal line) to the motor cortex. The stimulus intensity will be 80% of the patient's     motor threshold intensity.      Treatments will be given for 20 minutes per day over 10 working days. Both subjects received     high-frequency rTMS) received 10 Hz for 2 seconds per train; the intertrain interval was 58     seconds. For each participant the stimulus was administered over the right dorsolateral     prefrontal cortex.      Rating Scales      The ratings of PTSD symptoms, anxiety, and depression willm be carried out by an expert     investigator who will be blind to the stimulation condition. The patients will be assessed at     four time points—before TMS (baseline), at day 5, at day 10, and at day 24 (14 days after the     intervention). The instruments used will be as follows:      The PTSD Checklist The Treatment Outcome PTSD Scale The Hamilton Anxiety Rating Scale The     Hamilton Rating Scale for Depression PTSD symptoms were assessed by using the Hebrew version     of the Clinician-Administered PTSD Scale.   "
159446|NCT01196611|"     The study compares two different approaches of voice therapy. Vocal Functional Exercises     (Stemple,1997) and Voice Amplification using a portable amplifier (Tsi Supervoz II -     Tecnisystem do Brasil TSI 1210).   "
159447|NCT01196598|"     To verify if pelvic floor muscle training program and/or a hypopressive exercise program     could improve women with stage II of pelvic organ prolapse, their symptoms or pelvic floor     muscle strength.   "
159448|NCT01196585|"     This study aims to compare the diagnostic efficiency and reliability of Abrams' needle     pleural biopsy under computerized tomography guidance with that of cutting-needle pleural     biopsy under ultrasonography guidance in patients with pleural effusion.   "
159449|NCT01196572|"     The purpose of this study is to determine whether laser internal urethrotomy (IU) is as     efficient as cold knife internal urethrotomy for treatment of anterior urethral strictures     regarding post operative urination outflow, stricture recurrence rate and possible post-     operative complications   "
159450|NCT01196559|"     The purpose of this study is to evaluate the objective response rate and safety in     platinum-resistant epithelial ovarian/fallopian tube/primary peritoneal cancer patients     treated with vinorelbine and gemcitabine combination chemotherapy.   "
159451|NCT01196546|"     This study will assess the efficacy and safety of combination therapy of     vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000     mg/day.   "
159452|NCT01196533|"     1. Aim:           The aim of the clinical trial is to study the accuracy of the TensorTip device compared          with registered (FDA-approved) invasive and non-invasive devices.        2. Hypothesis:      Human physiological biomarkers may be measured from the color distribution of the internal or     external (skin) tissue. The technology of the TensorTip finger-mounted device is based on the     color distribution of the peripheral blood tissue, which enables the measurement of certain     biomarkers and vital signs under consideration.   "
159453|NCT01196520|"     Burkitt lymphoma (BL) is an aggressive monoclonal B-cell malignancy that is rare (sporadic)     worldwide, but is 100-fold more common (endemic) in equatorial Africa, particularly among     children. Epstein-Barr virus (EBV) and malaria are epidemiologically linked to endemic BL in     epidemiologic studies, but questions remain about role of EBV variants and the evidence for     association with malaria is weak. EBV is ubiquitous, yet only few children develop BL,     possibly because only a few EBV variants are pathogenically relevant. The association of BL     with malaria is based on ecologic and non-comparative clinical studies. Two case-control     studies have reported significant association of high anti-malarial antibodies with BL (OR=5_     among children in Uganda and in Malawi, but selection bias (cases and controls came from     dissimilar geographical areas) and reverse causality bias were limitations. Three studies     were conducted in the 1960s and 70s to test association of carriage of malaria-resistance     gene with BL, two of which reported a significant or marginal inverse association. These     pioneering studies were small (240 cases all together) and looked at one polymorphism in one     gene (sickle cell gene). Improvements in technologies to characterize genetic variation allow     the EBV and malaria hypotheses to be examined with greater power by looking at genetic     variation across multiple genes.      Epidemiology of Burkitt lymphoma in East African children and minors (EMBLEM) is a     case-control study of 1500 BL cases and 3000 age-, sex- and residence-frequency matched     controls we are proposing to conduct in East Africa. The study will enroll cases at four     hospitals in four regions in East Africa, where malaria transmission is holoendemic and year     round. The controls will be enrolled from general population attendees at Health Center II     (HC-II) units where the cases originated. The primary study objectives are: 1) to test the     hypothesis that genetic resistance to malaria is associated with a lower risk of BL, and 2)     to use genome-wide association methods to discover genetic variation that may be associated     with decreased or increased risk of BL. Because genetic variation conveys no information on     actual exposure to malaria or EBV, in secondary analyses, we will use empiric epidemiological     questionnaire and laboratory methods: a) to measure exposure to malaria and its association     with BL, and b) to measure EBV variants and their association with BL. To examine issues     related to bias and to obtain data to correct for deviations, we will also enroll 2250     population controls from 5% of the villages to obtain population distribution of key     exposures variables. This data will be used to reweight the distribution in HC-II controls     back to the general population.   "
159454|NCT01196507|"     Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal     varices with or without red color signs and have not bled previously will be enrolled. After     baseline evaluation, the participants will be randomized to receive either Placebo or     Carvedilol 12.5 mg BD. After randomization they will be followed up for one year. The primary     endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or     Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change     in CTP and MELD score& adverse events.   "
159465|NCT01196364|"     The investigators hypothesize exercise increases short term appetite and food intake, and     interferes with satiety and satiations to a preload in normal weight, boys.   "
159466|NCT01196351|"     The investigators hypothesize exercise increases short term appetite and food intake, and     interferes with satiety and satiations to a preload in normal weight, overweight and obese     boys.   "
159648|NCT01193907|"     This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations     of Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with     the currently licensed Vi polysaccharide vaccine   "
159528|NCT01195519|"     Currently, lots of researches aimed at quality of life of patients with peritoneal dialysis     and hemodialysis related issues. There is no study related to establish the predictive model     of quality of life. This study will investigate the predictive model of quality of life in     terms of peritoneal dialysis (PD) or hemodialysis (HD) patients. These results will offer the     further evidence to the government to develop the effective interventions for dialysis     patients. The optimal goal is to promote the quality care.   "
159455|NCT01196494|"     INTRODUCTION: There are several alternatives for one-stage emergency treatment of obstructive     left-sided colonic cancer (OLCC): subtotal colectomy, intraoperative colon lavage (IOCL) with     primary anastomosis, and the placement of a stent as a temporary measure prior to scheduled     surgery. At present, it is not clear whether emergency perioperative lavage or the placement     of a stent is the better technique. The hypothesis is that IOCL and primary anastomosis is     equal safe or even safer than placement of a stent as a temporary measure prior to scheduled     surgery, less length of stay and less cost.      OBJECTIVE: To establish which of these two techniques is more efficient in OLCC from the     point of view of morbimortality, economic cost, and long-term survival.      MATERIAL AND METHODS:      Prospective, controlled, randomized study of patients diagnosed with OLCC. Patients were     divided into two groups: group 1: stent and deferred surgery; group 2: emergency IOCL. A     simple randomization system was used. The estimated sample size required per group was 21     patients. Demographic variables, risk prediction models, postoperative morbimortality,     staging, complications due to the placement of stent, surgical time, clinical follow-up,     health costs and follow-up of survival were recorded.   "
159456|NCT01196481|"     Patients of cirrhosis will be enrolled who have large esophageal varices, which have never     bled. After successful screening baseline hepatic venous pressure gradient (HVPG) will be     measured. Tablet carvedilol 3.125 mg BD for 1 week will be started. It will be increased to     6.25 mg BD and continued for next 7 weeks. After completion of 8 weeks the hepatic venous     pressure gradient (HVPG) will again be measured to find out responders (hepatic venous     pressure gradient ≥20% reduction from baseline or absolute value of hepatic venous pressure     gradient <12 mm Hg) and non responders (hepatic venous pressure gradient <20% reduction).The     responders will be excluded from the study while the non responders will be randomize into     carvedilol+VSL#3 versus Endoscopic Variceal Ligation.   "
159457|NCT01196468|"     In Europe many patients infected with HIV remain undiagnosed, although this percentage varies     between 15-80% across the continent. In the UK it is estimated to be 27%. Undiagnosed HIV     results in increased morbidity and mortality and reduced treatment response, as appropriate     health interventions are delayed. It also has adverse public health implications, with those     individuals unaware of their HIV status being more likely to transmit the virus.      An important public health issue is how to diagnose more individuals with HIV earlier in the     course of their infection. In the US, the Centre for Disease Control and Prevention (CDC) has     introduced testing guidelines whereby all individuals are tested, unless they object, at any     point of contact with the healthcare system - the opt-out testing guidelines.      At the HIV in Europe Conference held in November 2007, the consensus, which included     patient and public involvement, was that such an approach would not be suitable for Europe.     The Conference recommended further development of focused HIV testing in patients presenting     with certain clinical conditions and diseases - the indicator disease'' testing guidelines.      Cost effectiveness analyses suggests cost savings if a screened population has an HIV     prevalence of at least 1%, although this rate may be as low as 0.1%. However, there is very     little - if any - evidence regarding HIV prevalence for certain conditions and diseases in     specific and easy to identify sections of society. The focus of attention is on those     conditions and diseases which occur more frequently in individuals known to be infected with     HIV.      The aim of this study is to assess HIV prevalence for several diseases and conditions, within     a specific segment of the population not yet diagnosed with HIV, who present for care with     that specific disease or condition. These conditions have been selected as they occur     frequently in individuals already diagnosed with HIV infection. This is a pilot study to     inform phase two, which will involve more diseases and conditions with a wider participation     of centres across Europe.   "
159458|NCT01196455|"     This is an open-label, non-comparative efficacy and safety study of Capecitabine and     Mitomycin C as first-line treatment in patients with previously untreated metastatic breast     cancer.   "
159459|NCT01196442|"     RATIONALE: Electrical stimulation pain therapy may help relieve chronic pain and numbness     caused by chemotherapy. PURPOSE: This pilot trial studies electrical stimulation pain therapy     in treating chronic pain and numbness caused by chemotherapy in patients with cancer.   "
159460|NCT01196429|"     This phase II trial studies how well temsirolimus, carboplatin, and paclitaxel as first-line     therapy works in treating patients with newly diagnosed stage III-IV clear cell ovarian     cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving temsirolimus with combination chemotherapy may be an     effective treatment for ovarian cancer.   "
159461|NCT01196416|"     This phase Ib/II trial studies the side effects and best dose of gamma-secretase/Notch     signalling pathway inhibitor RO4929097 when given together with cisplatin, vinblastine, and     temozolomide and to see how well they work in treating patients with recurrent or metastatic     melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as cisplatin, vinblastine, and temozolomide, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving gamma-secretase/Notch signalling pathway inhibitor RO4929097 together with     combination chemotherapy may kill more tumor cells.   "
159462|NCT01196403|"     RATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor than     is used in standard surgery. It is not yet known whether minimal-access surgery to remove the     bladder is more effective than standard surgery to remove the bladder in treating patients     with bladder cancer.      PURPOSE: This randomized phase II trial is studying standard surgery to see how well it works     compared with minimal-access surgery in treating patients with bladder cancer.   "
159464|NCT01196377|"     Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for     personalized medicine by identification of treatment-response phenotypes that are important     determinants of outcome. The Specific Aim of this study is to determine the feasibility of     this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different     albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr.     Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.   "
159480|NCT01196169|"     This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared     to another one which is vancomycin when given around the time of joint replacement surgery.     Vancomycin is recommended for perioperative prophylaxis in methicillin resistant     Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty.     Daptomycin has not been recommended for this indication but it is FDA approved for treatment     of MRSA blood stream and skin and soft tissue infections. Data collected during this study     may support the use of daptomycin for this indication and may also be used for other research     purposes that have not yet been specified.   "
159468|NCT01196325|"     The study will investigate changes in the structure and function of blood vessels in the     front and back of the eye following laser and anti-VEGF treatments for sight-threatening     diabetic eye disease. Sixty four volunteers will be recruited, including age-matched control     subjects and diabetic patients who require conventional or contemporary treatment for     pre-existing diabetic eye disease. Volunteers will be assessed before and after treatment     using state-of-the-art techniques to measure vision, the rate of blood flow and structure at     the front and back of the eye and the effectiveness of blood flow delivery. Changes following     treatment in these novel, non-invasive techniques will be quantified and described. We     anticipate that conventional and new / developing treatments will lead to narrowing of the     vessels and consequent reduction of blood flow at the back and front of the eye. There will     be a strong relationship between structural changes of the eye and functional changes of     blood vessels at the front and back of the eye. The results of this study will improve our     understanding of the impact of the various treatments on the entire eye. The research will     also ensure an improved understanding of the mechanisms of action of the various treatments     and will provide insight of reasons for good or poor outcomes, based upon specific changes in     structure and blood flow.   "
159469|NCT01196312|"     Anxiety Sensitivity Treatment for Heroin Users is a development project targeting mild and     above levels of anxiety sensitivity that will involve the testing of a specialized protocol     for improving treatment retention and outcomes for heroin dependent individuals in a     residential substance use treatment. ASTH-HR will integrate established treatment modules     such as Healthy Relationships, along with interoceptive exposure, affect management, and     psycho-education exercises developed for anxiety prevention and treatment programs with     standard substance use treatment.   "
159470|NCT01196299|"     This project aims to study the prognostic ability of various MRI imaging markers in the     evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at     each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison     to the TBI patients.      It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional     connectivity, and tissue microstructure will be related to the clinical status of the     patient, as well as their social and occupational outcomes.   "
159471|NCT01196286|"     The goal of this study is to determine whether pairing multifamily group psychoeducation with     cognitive remediation may facilitate improved outcomes among individuals with recent-onset     psychosis.   "
159472|NCT01196273|"     HIV-infection is associated not only with a reduced function of the immune system, but also     linked with diseases of other organ systems, in particular with the heart.      Heart conditions that have been described with HIV include        -  Pericarditis,        -  Pleural effusion        -  Pulmonary hypertension (Venedic classification typ II)        -  Dilated cardiomyopathy        -  Heart failure        -  Myocarditis        -  Bacterial endocarditis        -  Heart valve disorders In addition to previously stated disorders of the heart, the          premature atherosclerosis of coronary arteries, a further even more important disease of          the heart in this patient population, went into the focus of most HIV-researchers and          physicians.      Premature atherosclerosis of coronary arteries results in coronary calcification, angina     pectoris, myocardial infarction and sudden death. HIV-positive patients are at greater risk     for a variety of heart-related conditions, including coronary artery disease. It is assumed,     that HIV infection doubles the risk of a heart attack, according to recent research.      The reason for this link between HIV and heart-related conditions is unknown, but secondary     infections that affect the heart muscle and coronary arteries have a greater chance of     occurring in people with compromised immune systems. In addition, the HI-virus itself had     been detected in the myocardium and might have an impact on the premature of cardiovascular     diseases.      Furthermore, some of the medications used to treat HIV patients (antiretroviral therapy, ART)     are assumed to have heart-related side effects.      Therefore, current treatment regimens for HIV infection have to be balanced against the     marked benefits of antiretroviral treatment. Nevertheless, prevention of coronary heart     disease should be integrated into current treatment procedures of HIV-infected patients.      The link between the heart and HIV is well established but not well understood. Therefore,     further results are needed for efficient guidelines for the prevention, diagnostic and     therapy of HIV-associated cardiovascular diseases.   "
159473|NCT01196260|"     This study will examine a new combination of drugs: Capecitabine and Oxaliplatin for the     treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by     the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs     is experimental (not approved by the FDA as standard treatment), but is a widely used     treatment option and preliminary studies have shown that treatment with the combination has a     positive effect on metastatic colorectal cancer.   "
159474|NCT01196247|"     The purpose of the study is selecting second line therapy for patients with pancreatic cancer     using molecular profiling will improve 1 year survival.   "
159475|NCT01196234|"     This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for     2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor     receptor (EGFR) mutations.      Expanded acronym : [P]aclitaxel/Ca[r]boplatin (PC) followed by Gef[i]tinib in A[d]vanc[e]d     Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.   "
159476|NCT01196221|"     The aim of this study is to develop non-invasive MRI, and MRS approaches that will quantify     the plaque composition and lipid content of plaques and will have the potential for repeated     in vivo measurements. Simultaneously this study aims to develop US plaque imaging as a     screening tool to select plaque phenotypes of interest for clinical trials (a large LRNC).     For plaque composition imaging by MRI the researchers aim to increase scan resolution and     decrease scan time. For quantifying plaque lipid content the researchers aim to develop an     MRS protocol. Subsequently, the researchers intend to study the reproducibility of plaque     composition and lipid content measurements by MRI, MRS and Ultrasound in subjects that have     carotid artery plaques.   "
159477|NCT01196208|"     The purpose of this study is to provide the option of brentuximab vedotin treatment to     eligible patients in studies SGN35-005 and C25001   "
159478|NCT01196195|"     The trial will evaluate the pharmacokinetics, safety, efficacy and acceptability of twice-     and once-daily dosing of lopinavir/ritonavir tablets (Kaletra) dosed by weight in HIV-1     infected children who are currently taking lopinavir/ritonavir as part of their combination     antiretroviral therapy and who are currently achieving virological suppression (<50     copies/ml). Specifically:        -  To confirm weight-based dosing recommendations by evaluating the pharmacokinetics of          twice-daily lopinavir/ritonavir half strength formulation tablets dosed on body weight          and comparing to historical adult and paediatric data of pharmacokinetics of          lopinavir/ritonavir soft gel capsules and oral solution respectively (1, 2).        -  To compare the pharmacokinetics of twice-daily lopinavir/ritonavir tablets with          once-daily dosing in the same children.        -  To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to          twice-daily dosing in terms of virological suppression at 48 weeks. Adherence and          acceptability will also be compared.   "
159484|NCT01196117|"     Patients with Obstructive Sleep Apnea Syndrome (OSAS) will evidence higher levels of salivary     cortisol and alpha-amylase levels prior to use of placebo and continuous positive airway     pressure (CPAP) and will evidence a decrease in these levels after consistent use of     continuous positive airway pressure (CPAP) therapy as compared to placebo. Their level of     sleepiness will also decrease with the use of CPAP therapy and will correlate with the levels     of salivary cortisol and alpha-amylase in relation to their subjective sleepiness scale,     Psychomotor Vigilance Test (PVT), and pupillometry.   "
159485|NCT01196104|"     This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy     and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin     glargine versus insulin aspart in combination with insulin glargine in subjects with type 2     diabetes.   "
159486|NCT01196091|"     The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two     different doses of LY2127399 administered in addition to standard of care therapy in patients     with active SLE.   "
159487|NCT01196078|"     This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in     chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be     randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and     8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study     treatment is until disease progression.   "
159488|NCT01196065|"     This open-label, fixed sequence, two-period study will assess the effect of memantine on the     pharmacokinetics, safety and tolerability of a single oral dose of RO5313534 and the effect     of RO5313534 on safety and tolerability of steady-state memantine. Healthy volunteers will     receive a single oral dose of RO5313534 on Day 1 of Treatment Period 1 (3 days). After a     washout period of 5-21 days, oral memantine will be administered on Days 1-21 of Treatment     Period 2 and a single dose of RO5313534 on Day 19. There will be a follow-up of 3-4 weeks     after the last dose. Anticipated time on study for each volunteer is up to 14 weeks.   "
159489|NCT01196052|"     This single-arm open-label study assessed the safety, feasibility, and efficacy of     trastuzumab emtansine (T-DM1) after the completion of anthracycline-based     adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer.     Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17     cycles.   "
159490|NCT01196039|"     This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed     to evaluate the efficacy, safety and tolerability of MEMP1972A when administered to patients     by intravenous (IV) infusion for the treatment of allergen-induced asthma.   "
159491|NCT01196026|"     This study is designed to assess the immunogenicity, reactogenicity and safety following     vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been     vaccinated with two doses of Pandemrix at the age of 6 months-9 years.   "
159492|NCT01196013|"     The purpose of this study is primarily to assess the safety, tolerability and     pharmacokinetics (PK) of clofarabine intravenously administered to pediatric patients with     relapsed or refractory acute lymphoblastic leukemia (ALL) or for whom no other therapy with     greater potential clinical benefit exists. The dosing regimen for the intravenous (IV)     clofarabine is 30 or 52 mg/m2/day for 5 consecutive days. The secondary objectives are to     document the activity of clofarabine and to explore the impact of deoxycytidine kinase (dCK)     promoter polymorphism on PK and treatment outcome.   "
159493|NCT01196000|"     RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for     rectal cancer and may have fewer side effects and improve recovery. It is not yet known     whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in     treating patients with rectal cancer.      PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see     how well it works compared to laparoscopic surgery in treating patients with rectal cancer     that can be removed by surgery.   "
159494|NCT01195987|"     The purpose of this study is to study the role of the Immune System in causing arthritis in     patients with Hepatitis C.   "
159495|NCT01195974|"     This study is a two-period, double-blind study in healthy adult female subjects. Each subject     will participate in an oral contraceptive Run-in period prior to the treatment periods. The     length of the Run-in Period will be 28 days or longer, depending on the timing of the     subject's menstrual cycle and on whether the subject is taking an OC. Each subject will     participate in this run-in period (if needed), followed by two treatment periods. Treatment     Periods 1 and 2 must be conducted successively. Subjects will be randomized in a cross-over     fashion to either YASMIN with GSK2248761 or Placebo for 10 days and switch GSK2248761 or     placebo for another 10 days. Subjects will return to the study center for final follow up     evaluations 7 - 14 days after the final dose of study medication.   "
159496|NCT01195961|"     Background:      - Developmental dyscalculia is a learning disability in which individuals have difficulty     learning or comprehending mathematics or other number concepts (such as keeping score during     games, measuring time, or estimating distance). Developmental dyscalculia affects certain     parts of the brain that are required for processing numbers. Research has shown that a form     of brain stimulation called transcranial direct current stimulation (tDCS), applied when     healthy individuals are being trained to carry out tasks with numbers, improved the ability     to process numbers and solve math problems. More research is needed about whether tDCS can     improve number processing in people with developmental dyscalculia.      Objectives:      - To examine whether the effects of transcranial direct current stimulation can help     individuals with developmental dyscalculia perform mathematical calculations.      Eligibility:      - Individuals between 18 and 50 years of age who have been diagnosed with developmental     dyscalculia, or are healthy volunteers without dyscalculia.      Design:        -  Participants will have a screening visit and seven study visits. The screening visit and          six of the study visits will take place consecutively over the course of 6 days, and the          final visit will take place 3 months after the initial participation.        -  Participants will be screened with a medical history, physical and neurological          examination, and a brief examination to test for dyscalculia and determine the          participant's dominant hand.        -  Participants will be randomly assigned to one of two groups for the study. One group          will receive tDCS during training to perform a task with numbers, and the other group          will receive the same training with sham stimulation. Participants will not know which          group they are in.        -  During the study visits, participants will be trained on number tasks on 6 consecutive          days. Before the tDCS or sham stimulation is applied at the beginning of the experiment          and at the end of each training day, participants will perform other tasks with numbers.          Participants will be evaluated based on the accuracy and speed with which they respond          to the questions.        -  At the followup visit, participants will perform the same number tasks they completed          during the study visits. No tDCS will be performed at this visit.   "
159545|NCT01195298|"     This is an open-label, single-arm, multicenter study of capecitabine and bevacizumab     administered as first-line treatment of previously untreated elderly patients, older than 70     years, with metastatic or locally recurrent breast cancer.   "
159546|NCT01195285|"     This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to     traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and     cost.   "
159497|NCT01195948|"     Background:      Uveitis is a serious inflammatory condition in which the body's immune system attacks parts     of the eye, often causing vision loss. Uveitis treatments involve various drugs that suppress     the immune system, but these medicines sometimes do not work or may cause serious side     effects. Researchers are interested in developing new treatments for uveitis that are more     effective and have fewer side effects.      Optiquel® is an experimental medication being tested for its effectiveness against uveitis.     It contains B27PD, a small protein fragment, which is similar to proteins in the parts of the     eye being attacked by the immune system. Taking Optiquel® (B27PD) by mouth may induce oral     tolerance, in which the immune system is taught to recognize and not attack normal parts of     the human body.      Objectives:      To evaluate the safety and effectiveness of B27PD (Optiquel®) as a treatment for uveitis.      Eligibility:      Individuals at least 18 years of age who have had noninfectious uveitis in one or both eyes     for at least 3 months, have vision of 20/200 or better in at least one eye, and are taking     daily prednisone or an equivalent medication.      Design:      Participants will be screened with a physical examination, medical history, blood and urine     tests, and an eye exam.      This study will last a maximum of 52 weeks. During the first 12 weeks of the study,     participants will have a study visit every 2 weeks. For the remainder of the study,     participants will have a study visit every 4 weeks.      Participants will have frequent blood and urine tests, and will also have eye examinations     and special procedures (fluorescein angiography and indocyanine green angiography) to     evaluate the effectiveness of the treatment.      Participants will be randomly assigned into one of three groups and will receive either one     of two different doses of B27PD or a placebo. During the study, participants will also have     their dose of prednisone or other steroid medication reduced.      Participants will take one capsule three times per week on Monday, Wednesday, and Friday, for     a total of 24 weeks. Participants may take the capsule with water, but should not consume any     other drinks or any kind of food until at least 30 minutes have passed to prevent stomach     upset. The capsules should be stored in the refrigerator.   "
159498|NCT01195922|"     Background:      - Advanced-stage head and neck cancer (head and neck squamous cell carcinoma [HNSCC]) has     moderately successful treatment outcomes, usually involving surgery as part of the standard     treatment. Researchers are investigating the use of the drug rapamycin to prevent tumor     growth in HNSCC, and are interested in using it to treat individuals with HNSCC that has not     been treated previously with other drugs, radiation, or surgery.      Objectives:      - To evaluate the usefulness of rapamycin in decreasing tumor size prior to surgery for head     and neck squamous cell carcinoma.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with advanced head and neck     squamous cell carcinoma that has not yet been treated.      Design:        -  Participants will be screened with a physical examination, medical history, blood tests,          and imaging studies.        -  Approximately 1 month before scheduled surgery, participants will begin to receive          rapamycin. Participants will take rapamycin once daily for 21 days, followed by a 7-day          period without the drug.        -  During the 21-day rapamycin treatment, participants will have weekly study visits to          provide blood and urine samples and have possible tumor biopsies and imaging studies          such as x-rays or tumor photographs. Participants will have additional study visits for          tests 1 day and 1 week after the end of rapamycin treatment, followed by HNSCC surgery.        -  Participants will have a final visit to provide blood samples 30 days after surgery.        -  Participants medical records will be reviewed 1 year after surgery; however,          participants will not need to have further study visits at this time.   "
159499|NCT01195896|"     The investigation is designed as a prospective, open, non-controlled clinical investigation.   "
159500|NCT01195883|"     A trial in which patients having open abdominal surgery are randomized to receive either     crystalloids or colloids intraoperatively, guided by esophageal Doppler. The investigators     test the primary hypothesis that goal-directed colloid administration during elective     abdominal surgery decreases a composite of postoperative complications within 30 days of     surgery.   "
159513|NCT01195714|"     This study is a multicentric, phase II, open-label, non-randomized trial evaluating the     efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+     diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a     performance status ECOG from 0 to 4.      The anticipated study dates (start / end) are: 2010 - 2013. The study will evaluate a cohort     of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in     Portugal).      Patients will be recruited over 30 months and followed at least one year after the last     patient has been included.      The duration of the treatment period is approximately 20 weeks.   "
159501|NCT01195870|"     Multiple sclerosis (MS) is a chronic disease which causes inflammation and destruction of the     nerves in within the brain and the spinal cord. This disease is one of the most common causes     of disability in young adults. A ''relapse'' is a phenomenon that occurs when there is an     acute attack of disability as a result of an acute attack on the nervous system. There is     usually some degree of recovery after a relapse.      Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3     times a week by injections under the skin. The RebiSmart device is a new injection device     which has been developed to help patients with injecting their Rebif treatment.      Currently, all treatments for MS are injectable and require long term patient commitment.     Patient compliance to treatment is important for the therapy to work effectively and decrease     the risk of relapse episodes. Using a device that makes it easy for patients to inject may     potentially improve compliance to treatment and therefore potentially have an impact on the     number of relapses patients experience. The RebiSmart device has been developed for patients     to inject conveniently and in comfort. The device allows the patient to control certain     parameters such as needle depth, needle speed, injection time etc, and also has extra     features designed to ease the injection process, such as a dose history calendar and an     on−screen injection guide. The aim of this study is to determine what percentage of patients     liked using the RebiSmart device and found it ''easy'' or ''very easy'' to use. The study     will also determine which of the device features were most useful to the patients.   "
159518|NCT01195649|"     The primary objective of this prospective, observational, post-marketing study is to evaluate     the patient characteristics, pre-treatment and treatment duration in Renal Cell Carcinoma     (RCC) patients who are candidates for systematic therapy and in whom a decision to treat with     Nexavar® has been made under real-life practice settings and approved reimbursement     restriction in Taiwan. Therefore, the main objective of the study is to collect data on:      Prescription pattern: to determine the factors affecting compliance and duration of treatment     with special attention given to education status, demography, disease details, pre-treatment,     concomitant medication and other baseline data      Nexavar® treatment and efficacy data      Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0   "
159519|NCT01195636|"     The purpose of this trial is to determine if XPF-002 is safe and effective for the treatment     of pain in subjects with Postherpetic Neuralgia   "
160781|NCT00000218|"     The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine     craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric     disorders.   "
159502|NCT01195857|"     Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central     nervous system (CNS) and is one of the most common causes of neurological disability in young     adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is     given 3 times per week by subcutaneous injection. The Rebiject II device is an autoinjector     which allows patients easier administration of their Rebif injections.      Prior to treatment, patients receive training on the use of the device and its maintenance.     Currently, all treatments for MS are injectable and require long term patient commitment.     Rebiject has been developed to improve patient convenience and comfort but does require     multiple steps to be carried out in order for the injection to be delivered correctly.     Reports from our local call centre and nurse advisors suggest that inaccuracies of use with     the Rebiject device are common. By raising awareness of the level of inaccuracy and     determining which steps patients are most likely not to complete correctly, modified training     programs or modifications to current subject training may be put into place to address these     issues. It is also important to demonstrate the link between poor use of the medication     device and increased relapse rates or increased injection site reactions.   "
159503|NCT01195844|"     This is a 1-year study evaluating hospitalizations and the medical care for the treatment of     diarrhea from rotavirus infection in children < 5 years of age, conducted in four hospitals     located in four Brazilian regions. A stool sample from each eligible child passing 3 or more     loose stools or watery stools within a period of 24 hours and requiring hospitalization or     rehydration therapy (oral or IV rehydration) will be tested for the presence of rotavirus,     using standard laboratory procedures (ie, Enzyme Linked Ligand Sorbent Assay, or ELlSA) by     all participating hospitals.   "
159504|NCT01195831|"     The purpose of this study is to compare the clinical efficacy of once daily treatment for 4     weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4     weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis.   "
159505|NCT01195818|"     The prevalence of Sickle Cell Associated Nephropathy (SCAN) is increasing and is a growing     concern. Microalbuminuria is detected in the early onset of SCAN. Noteworthy, as in diabetic     nephropathy, hyperfiltration seems to be a frequent finding, with, in our series, an overall     incidence of 57 % and suggests a pathological links between glomerular hyperpressure and     glomerulosclerosis which occurs several years after. Nitric oxide (NO) deficiency and the     renin angiotensin system (RAS) are likely to be involved in the glomerular hyperpressure     leading to hyperfiltration. Renin angiotensin antagonists are currently given for     NEPHROPROTECTION in numerous nephropathy including SCAN despite few available reports. The     percentage of decrease of albuminuria or the percentage of responders (ie patient normalizing     albuminuria) has never been reported to our knowledge in SCAN patients at the time of     hyperfiltration. The focus of our study is therefore to 1) Quantify albuminuria reduction     after 6 months RAS treatment (primary end point); 2) Quantify glomerular filtration rate     (GFR) reduction after 6 months of RAS treatment, and to test the hypothesis of a beneficial     effect of RAS inhibitors on several biomarkers assessing hemolysis, NO inhibition and the     endothelial damages (secondary end points). The ultimate aim of our study is to identify     relevant (new) biomarkers associated to hyperfiltration and/or albuminuria decrease     (/normalization).   "
159506|NCT01195805|"     The investigators wish to study the effect of retaining potassium. The participants have     essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The     participants will ingest tablets for 28 days before being examined. We will perform a 24     hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we     also examine the patient using a SphygmoCor.   "
159507|NCT01195792|"     The purpose of this study is to determine whether GSK1521498 will cause weight loss in obese     but otherwise healthy subjects with over-eating behaviours.   "
159508|NCT01195779|"     The purpose of this observer-blind study is to evaluate the safety and immunogenicity of     GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months     of age.   "
159509|NCT01195766|"     The aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome     patients that have a first line chemotherapy treatment failure due to refractoriness, partial     response or relapsed.      In the same way, mortality, global survival and free-progression survival after O-ESHAP     treatment and TAPH will also analyzed.   "
159510|NCT01195753|"     Treatment with liver cell infusion for children with urea cycle disorders (UCD).   "
159511|NCT01195740|"     Few empirically-based treatment models exist for adolescent suicide attempters post     psychiatric hospitalization, despite the fact that managed care has limited the role of     hospitalization to stabilization, rather than remission. This study will test the efficacy     and initial outcomes of Attachment Based Family Therapy (ABFT) as an aftercare model to     further gains made in inpatient treatment and reduce risk factors for future suicide     attempts.   "
159514|NCT01195701|"     Women who are unable to achieve orgasm compared to women who have normal orgasmic function     may have different clitoral anatomy and different hormone levels. The investigators     hypothesis is that women who have difficulty with orgasm may have a clitoris that is closer     to the vagina and may have higher testosterone levels. Pelvic MRI will be used to observe     whether clitoral measurements differ between women with normal orgasmic function vs. those     with anorgasmia.   "
159515|NCT01195688|"     The primary objective of the current study is to investigate the safety and tolerability of     BI 638683 in healthy male volunteers following oral administration of single rising doses   "
159516|NCT01195675|"     The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c)     interval more than placebo   "
159517|NCT01195662|"     The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can     improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled     hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin     Receptor Blocker (ARB).The safety of this treatment will also be studied   "
159627|NCT01194349|"     Thrombocytosis, mostly reactive in nature, is common in pediatric hospitalized patients with     infections. Streptococcus pneumoniae (S. Pneumoniae) is the most common pathogen. In this     study, the investigators investigated the associations of clinical profiles and     thrombocytosis and evaluated platelet counts, leukocyte counts and CRP levels as predictors     of hospitalization days in patients with S. pneumoniae infection.   "
159520|NCT01195623|"     Duplex imaging is costly and time-consuming, but is used increasingly for preoperative     evaluation of varicose veins. Its value in terms of the long-term results of surgery is not     clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation with     or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings were     compared at 2 months and 2 years after surgery. Routine preoperative duplex examination led     to an improvement in results. However two years is a short time, and with a longer follow-up     other mechanisms for recurrence may become more important, e.g. neovascularization (new     vessel formation) or progression of disease, hence the value of a detailed preoperative     diagnosis may be diminished. The aim of this phase of the investigation is to study the     results after 8 years, in particular what mechanisms for recurrences were most important.   "
159521|NCT01195610|"     The objective is to investigate whether New Nordic Diet (NND) versus Average Danish Diet     (ADD) in adults (18-65 y) with central obesity and components of the metabolic syndrome can     improve body weight loss and risk markers of the metabolic syndrome, type 2 diabetes and     cardiovascular diseases.   "
159522|NCT01195597|"     The study's major aim is to investigate the ability of a commercial Electronic Nicotine     Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling     to quit. Secondary aims are to monitor adverse events and measure participants' perception     and acceptance of the product.      This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and     adverse events of a currently marketed device in Italy (Categoria electronic cigarette -     ORIGINAL 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a     safe device that allows smoking reduction or abstinence in smokers.   "
159523|NCT01195584|"     The study concerns a retrospective analysis of all subjects operated as of 1st Jan 2008 using     Minimal Access Surgical Technique (MAST). The study is descriptive in nature and will present     the observation of all cumulated patients operated with MAST.      The study data will include the general health information of the subjects prior to surgery,     information on the surgery such as OP time, blood loss, and the postoperative wound healing     process (until discharge), which is on average the 10th postoperative day.   "
159524|NCT01195571|"     The purpose of this research study is to test the safety and tolerability of four new     investigational Cytomegalovirus (CMV) vaccines (Towne-Toledo 1, 2, 3, 4) in healthy male     volunteers who are CMV negative. CMV is a common virus, infecting 50-80% of adults in the     United States by the age of twenty-one. CMV does not usually cause illness in adults or     children. However, CMV can be a cause of deafness and mental retardation in a child if a     mother is infected during pregnancy. It also can be a serious illness in patients with     impaired immunity (decreased ability to fight infection).   "
159525|NCT01195558|"     Non-24-hour sleep-wake disorder (Non-24) is a condition experienced primarily by totally     blind individuals that results in abnormal night sleep patterns and chronic daytime     sleepiness. This is a research protocol to develop a patient registry of subjects who may     suffer from Non-24 and who are blind. Subjects participate in the study through a phone     survey. This registry will be used to better understand, sleep related problems in blind     individuals, including the investigation of a potential treatment, recruitment for future     clinical studies, and to provide a forum for raising awareness about Non-24. The survey     consists of questions regarding the degree of vision impairment and sleep problems that the     subjects may be experiencing.   "
159535|NCT01195428|"     Acute Lung Injury/Acute respiratory distress syndrome (ALI/ARDS) is a serious and frequently     encountered entity in modern ICUs. Sepsis remains the most common cause of ALI/ARDS and     carries the worst prognosis. The disease is characterized by an intense inflammatory process.     This inflammation plays a major role in the development of gas exchange abnormalities seen in     the course of the disease. Statins, primarily used as lipid-lowering agents, are now known to     possess anti-inflammatory, antioxidant, antithrombogenic and vascular function-restoring     actions. Therefore the investigators propose to determine if Simvastatin may be useful in     decreasing the incidence of this deadly syndrome in critically ill patients.   "
159536|NCT01195415|"     This pilot clinical trial studies vismodegib and gemcitabine hydrochloride in treating     patients with advanced pancreatic cancer. Vismodegib may stop the growth of pancreatic cancer     by blocking blow flow to the tumor. Gemcitabine hydrochloride may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving vismodegib and     gemcitabine hydrochloride may kill more tumor cells.   "
159526|NCT01195545|"     This is an investigator initiated pilot study to observe the short-term outcomes (a follow-up     period of up to six months) of patients who undergo a laparoscopic paraesophageal Hiatal     hernia (PEH) repair using the Veritas® Collagen Matrix brand biological mesh. This is a     preliminary study at the University of Washington.      A PEH occurs when the stomach protrudes through the diaphragm next to the esophagus. The     chance of recurrence of a Hiatal hernia after laparoscopic PEH repair is between 20-40%     within 6 months.During laparoscopic PEH repair, a mesh-type product is used as a scaffold.     The mesh serves as a reinforcing material during the surgical repair. It is cut to the     appropriate size needed for the hernia and sutured to the surrounding diaphragmatic tissue.     There are many different types of meshes available on the market, and vary in the degree of     manageability, strength, and adherence.      Although surgical meshes work on the same principal, the variance between materials may     affect patient outcomes. There is evidence that a biologic mesh, specifically one derived     from Small Intestinal Submucosa (SIS), decreases the short-term (6-month) recurrence rates     compared to a synthetic mesh or another type of biologic mesh. A biologic mesh, serving as a     scaffold, will be replaced by the patient's own tissue after about 6 months. Theoretically,     this would prevent the possible complications associated with synthetic mesh including mesh     erosion into the esophagus or stricture of the esophagus.      There are some case series showing similar short-term results between the different biologic     meshes, but there is no direct comparative data.   "
159527|NCT01195532|"     The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different MR     tablets of gliclazide after single oral administration at the same doses to healthy subjects.   "
159628|NCT01194336|"     The primary objective of this study is to determine whether huperzine A, donepezil, and     galantamine impact militarily relevant aspects of neurocognitive performance in humans,     compared to placebo.   "
159529|NCT01195506|"     Vascular endothelial growth factor (VEGF)-C is recognized as a tumor lymphangiogenic factor     based on the effects of activated VEGFR3 on lymphatic endothelial cells. VEGFR3 has been     proposed as a specific marker for lymphatic endothelial cells. Recent studies indicated that     VEGFR3 also expressed in a variety of human malignancies, including lung, colon rectal, or     head and neck cancer. Moreover, VEGF-C/VEGFR3 axis was demonstrated in regulating     angiogenesis, cell invasion, and metastasis in several solid tumors. The promotion of cell     mobility in response to VEGF-C was required the involvement of adhesion molecule contactin-1.     In addition to solid tumors, it has been reported that the VEGF-C/VEGFR3 axis is activated in     subsets of leukemia patients. Until now, it has been demonstrated that higher endogenous     VEGFC levels of acute myelogenous leukemia (AML) cells are related to decreased in vitro and     in vivo responsiveness to chemotherapy; an effect that may result from inhibition of     apoptosis by increasing Bcl-2/Bax ratios by the VEGF-C/VEGFR3 pathway. Thus, a functional     VEGF-C/VEGFR3 system may exist in leukemia. However, the detail information concerning the     role of VEGF-C/VEGFR3 in non-solid tumors is still lacking. Bone marrow neoangiogenesis plays     a crucial pathogenic and possible prognostic role in AML. The VEGF-C/VEGFR3 axis has been     proven in the regulation of solid tumors angiogenesis. In the investigators preliminary     study, the investigators found VEGF-C may play a critical role in angiogenesis regulation of     leukemic cells by upregulating cyclooxygenase-2 (COX-2). Furthermore, the investigators found     that the upregulation of COX-2 also correlate with the VEGF-C-induced proliferation in     leukemic cells and this phenomenon might further regulate the chemoresistance of VEGF-C. In     this study, the investigators will investigate the extent of angiogenesis and chemoresistance     induced by VEGF-C in leukemic cells. This study will provide evidences on the subject of the     novel role of VEGF-C in leukemia. With progress in molecular biology of VEGF-C, its value as     a therapeutic target is highly promising.   "
159530|NCT01195493|"     Chronic periodontitis is a common infectious disease characterized by progressive attachment     loss and alveolar bone resorption eventually resulting in tooth loss. The ultimate goal of     periodontal therapy is to prevent this endpoint. At least when a strict supportive care     program is implemented following active therapy, subsequent tooth loss is limited to a mean     of about 0.1 per patient per year. In contrast, three to six times as many teeth may be lost     if the disease is left untreated.      The objective of supportive care is to prevent disease recurrence, which is accomplished by     strict home care and professional plaque control at regular intervals depending on the     patient's needs. Evidently, not all patients are optimally compliant in terms of plaque     control. Therefore, chemical aids could be administered to supplement mechanical plaque     removal.      Essential oils solutions containing menthol, thymol, methyl salicylate and eucalyptol as     active agents may be more appropriate to supplement daily home care. Clinical studies have     shown an additional anti-plaque and anti-gingivitis effect over mechanical plaque control     without relevant side effects in healthy subjects and gingivitis patients.      Recently, significant reductions of periodontopathogens in the subgingival biofilm have been     shown in periodontitis patients following subgingival irrigation using an essential oils     solution. In addition, mouthrinsing on a daily basis seemed to substantially alter the     subgingival microflora towards a less pathogenic one in gingivitis and periodontitis     patients. Even though these are interesting findings, they should be considered exploratory     since they relate to a small number of patients observed for only two weeks.      The goal of the present study was to thoroughly document the clinical and microbiological     effects of an essential oils solution used on a daily basis for 3 months as an adjunct to     mechanical plaque control measures in a large number of chronic periodontitis patients in     supportive care.   "
159531|NCT01195480|"     The aim of this clinical trial is to evaluate the feasibility, safety and biological effect     of adoptive transfer of CD19ζ chimaeric receptor transduced donor-derived EBV-specific     cytotoxic T-lymphocytes (EBV-CTL) in patients with high-risk or relapsed B cell precursor ALL     after allogeneic Haematopoietic Stem Cell Transplantation (HSCT).   "
159532|NCT01195467|"     The purpose of the study is to investigate the benefits of switching away from efavirenz     (part of the combination pill, Atripla®) in patients with central nervous system side effects     (such as insomnia {difficulty with sleeping}, bad dreams etc). The investigators will     investigate the effect of switching to Truvada (a combination pill of tenofovir and     emtricitabine, the other two components of Atripla) plus raltegravir.      Raltegravir is a licensed drug for HIV treatment which showed side effects were fewer in     number when compared to efavirenz in 2 other clinical studies, where patients were starting     HIV treatment for the first time.      This study will also investigate the safety (in terms of other side effects and the routine     blood tests which the investigators ordinarily use to monitor your treatment) and monitor     effectiveness, your viral load and CD4 counts, when you switch treatment from Atripla® to     Truvada/raltegravir.   "
159533|NCT01195454|"     Primary Objective:      - To assess the total metabolic effect ratios of a new insulin glargine formulation versus     Lantus®      Secondary Objectives:        -  To assess the exposure ratios of a new insulin glargine formulation versus Lantus®        -  To compare the duration of action of a new insulin glargine formulation versus Lantus®        -  To explore the dose response and dose exposure relationship of a new insulin glargine          formulation        -  To assess the safety and tolerability of a new insulin glargine formulation   "
159534|NCT01195441|"     The purpose of this study is to determine whether the Fetal Medicine Foundation algorithm for     individual risk calculation for preeclampsia (PE) and pregnancy induced hypertension (PIH) is     suitable to identify women in high risk of developing these diseases in a Norwegian     population.   "
159541|NCT01195350|"     Stroke is the leading cause of mortality in Brazil. Strict blood pressure control in chronic     phase is the major measure to primary and secondary prevention, but in acute phase is not     clear the best blood pressure level. Few studies demonstrate a U relationship between blood     pressure and lethality; nevertheless any Brazilian study has addressed this issue.      This is a prospective observational study on the relationship between BP and mortality in the     acute phase of stroke. The study will be conducted in the Adult ICU of HC-UNESP. Will be     analyzed 266 patients aged 18 years and of both sexes admitted to the ICU with a diagnosis of     hemorrhagic and ischemic stroke. Participants will be divided into three groups according to     the initial PA present:      Group A: Patients with systolic BP of entry below 140 mmHg; Group B: Patients with systolic     BP of entry between 140 and 180 mmHg; Group C: patients with systolic BP greater than 180     mmHg entry. Multiple logistic regression analysis will be done to verify the association of     blood pressure and lethality adjusted to confounding variables.   "
159542|NCT01195337|"     The goal of this study is to learn why some black and Latino men and women choose not to     exercise very often. Researchers also want to learn more about any social and environmental     factors that may affect the way an exercise program is followed.   "
159543|NCT01195324|"     The purpose of the study is to assess the effect of multiple oral doses of canagliflozin on a     single oral dose of warfarin.   "
159544|NCT01195311|"     This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360     (study drug) is safe, well-tolerated and effective in patients with advanced malignancies.     Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28     days before the next group is enrolled and may begin to receive study drug. For subject     safety, the first subject in each cohort will be administered drug for one week before the     next two subjects in the cohort can begin drug administration. Doses will be escalated unless     a dose-limiting toxicity (DLT) is observed in one of three subjects.      An expanded cohort of up to 15 patients may be recruited to further explore safety at the     'maximum tolerated dose' or at a lower, pharmacologically active, dose.   "
159547|NCT01195272|"     This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab)     on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in patients     with active rheumatoid arthritis who have an inadequate response to current biologic or     non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive     RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks, either as monotherapy or     in combination with their current non-biologic DMARD. Anticipated time on study treatment is     52 weeks.   "
159548|NCT01195259|"     Observational analyses of data from population registeries have suggested that metformin may     be associated with a decreased prevalence of malignancy. The ADOPT and RECORD studies both     contain groups of subjects randomly allocated to metformin and rosiglitazone. This     meta-analysis combines malignancy serious adverse events from ADOPT and RECORD in order to     compare their incidence on metformin with that on rosiglitazone.   "
159549|NCT01195246|"     The purpose of this study is to compare the immune response to HEPLISAV™ booster injection     with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with     end stage renal disease (ESRD) on hemodialysis.   "
159550|NCT01195233|"     The present study compared the efficacy of BioXtra spray and mouth rinse in the relief of     radiotherapy-induced xerostomia in patients referred to Cancer Institute, Tehran Imam     Khomeini Hospital.   "
159551|NCT01195220|"     Project Aware introduces a sexually transmitted infection (STI) screening model for sexually     experienced adolescents aged 14 to 21 in a large, inner-city Emergency Department (ED) in the     Bronx, N.Y. Project Aware will scaffold routine, rapid testing and counseling for Chlamydia     trachomatis (CT) and Neisseria gonorrhoeae (GC) onto an existing, successful, ED-based HIV     testing and counseling program, Project BRIEF. Project Aware will educate and motivate youth     to use condoms with the aid of a theory-based, youth-friendly multimedia behavioral     intervention proven to be effective during the investigator's K23 training. Through Project     Aware, the investigators propose to change the paradigm of STI testing. Whereas a view of     HIV exceptionalism has persisted in U.S. health policies on STI testing, the investigators     propose a comprehensive approach, in which efforts to identify, treat, and prevent multiple     STIs coalesce in one program. The research study has two phases. In the production phase, new     STI material will be added to the multimedia intervention currently used for HIV education.     In the evaluation phase, a randomized controlled trial (RCT) will be conducted to assess the     effectiveness of Project Aware in identifying, treating, and preventing new STI infections     among high-risk adolescents. The RCT is designed to test the incremental effectiveness of     three STI prevention methods: (1) HIV testing and counseling (T&C), (2) HIV T&C and STI     testing, and (3) HIV/STI Testing plus a point-of-service risk reduction video that     incorporates both HIV and STI counseling and education. The study is powered to examine three     STI prevention outcomes: (1) the number of STI infections identified and treated successfully     at baseline; (2) the number of new STI infections over the 12 months following study entry,     identified by (a) performing STI testing at each follow-up assessment; and (b) obtaining     anonymized rate data on STIs reported to the New York City Department of Health; (3) condom     use behavior. 600 youth aged 14-21 will be enrolled in the RCT. Youth will be approached in     the ED waiting room and recruited by Public Health Advocates. All will complete a survey to     screen for eligibility; eligible youth will complete the baseline measures and be randomized.     The follow-up data points and measures will be followed at 4, 8 and 12 months (4 time points)     and STI testing will be included.   "
159552|NCT01195207|"     This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma.   "
159553|NCT01195194|"     The objective is to assess if low pre-transplantation donor specific T-cell reactive patients     measured by Enzyme-linked immunosorbent spot (ELISPOT)assay can be safely managed with     Calcineurin inhibitor(CNI)-free Sirolimus(SRL)-based immunosuppression.   "
159577|NCT01194869|"     The purpose of this study is to identify new treatment regimens with better response rates     and to find out if the combination of cisplatin and sorafenib followed by paclitaxel and     sorafenib can shrink the size of your breast tumor and allow you to preserve your breast.     Sorafenib is a newer drug that targets blood vessel formation and may help the chemotherapy     work better. Additionally, by receiving chemotherapy before surgery, we will be able to     determine if your cancer is responsive to chemotherapy.   "
159649|NCT01193894|"     This study aim to investigate the effect of Profermin versus Fresubin in the dietetic     treatment of active ulcerative colitis.   "
186070|NCT00278707|"     The purpose of this study is to determine whether oral supplementation of glyceryl triacetate     improves the clinical prognosis of Canavan Disease.   "
159554|NCT01195181|"     Hepatitis C virus (HCV) infection provokes thousands of deaths every year all over the world,     being the major cause of progressive liver disease, primary hepatic cancer and liver     transplantation. Today, a curative therapy is available, that can eradicate the viral     infection and determine the regression of liver fibrosis, also in cirrhotic subjects.      The current standard-of-care for HCV chronic infection is combination therapy with     peginterferon (P-IFN) and ribavirin (RBV). However, this treatment is not only expensive but     determines several side effects, that can reduce drug tolerance and hence, patient adherence     to therapy. There are two types of available P-IFN on the market: P-IFN alfa-2a (Pegasys®,     F.Hoffmann-La Roche) administered at a flat-dose of 180 mcg/week and P-IFN alfa-2b     (PegIntron®, Schering-Plough) given at a weight-based dose of 50 to 150 mcg/week. Since only     a single amino acid differentiates these types of IFN, administration strategies depend on     their pegilation with molecules of 40 or 12kDa, respectively, that accounts for differences     in the pharmacokinetic and pharmacodynamic drug-profile and influences probably also     bioactivity. No comparative data are available on the benefits and costs of the licensed     Peg-IFN plus RBV for the treatment of HCV infection in the real clinical practice, even if,     the benefit and favourable cost-efficacy of this antiviral therapy is well established and of     large consensus. Recently, the first randomized controlled mega-trial to compare antiviral     therapeutic efficacy in naïve patients with HCV-genotype 1 infection during different     regimens of P-IFN alfa-2b (at low and standard-dose) and P-IFN alfa-2a plus RBV, has been     published, confirming a similar efficacy, of around 40%, obtained with the three schedules     evaluated.      In Italy, a regional program on the Surveillance and Control of HCV Infection, set up by the     Regional Health Councillorship, has led to the development of a clinical and epidemiological     observatory, constituted by a network of liver tertiary centres (Hepatological Cooperative     Network of Veneto, HepCoVe). This collaborative group is connected on-line by a common     database that, since 2003, has prospectively collected data on a cohort of more than 3000     patients with chronic HCV infection and, among them, of 506 naïve subjects that consecutively     underwent combination therapy with P-IFN alfa-2a or alfa-2b plus RBV.      The aim of this study was to rationalize and improve the social regional health program on     antiviral treatment of chronic hepatitis C by assessing the different schedules utilization     of P-IFN plus RBV as well as the respective therapeutic effectiveness, safety and costs in     the real clinical practice (Project A).   "
159555|NCT01195168|"     Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more     insulin resistant than women without the condition and may be at greater risk of developing     cardiovascular disease. It is not know whether it is the overweight and insulin resistant     component of PCOS, or PCOS per se which leads to the greater cardiovascular disease risk. The     aim of this study was to examine cardiovascular risk markers in women with PCOS versus a     control population matched for body mass index (BMI), and or, insulin resistance   "
159673|NCT01193582|"     A vaccine called Prevenar is already approved for use in China for vaccination of children     younger than 6 years old against infections caused by Streptococcus pneumoniae.      This study is to measure the amount of antibodies (antibodies help people fight off diseases)     Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar.     The study will also provide more data on how safe and well tolerated Prevenar is in Chinese     children.   "
159556|NCT01195155|"     Adipose tissue is a central organ involved in mediating metabolic health, and so the     investigation of treatments which improve adipose tissue function is warranted. LC n-3     polyunsaturated fatty acid (PUFA) have been shown to exert positive effects on adipose tissue     gene expression in previous studies. However this has not been investigated in women with     polycystic ovary syndrome (PCOS), a population shown to display a degree of adipose tissue     dysfunction. The aim of this study was to determine the impact of LC n-3 PUFA supplementation     on gene expression profiles of women with PCOS.   "
159557|NCT01195142|"     Adipose tissue is a central organ in mediating metabolic health. There is some evidence that     women with polycystic ovary syndrome (PCOS) have a degree of adipose tissue dysfunction which     may negatively affect their metabolic health. The aim of this study was to assess     transcriptomic profiles of subcutaneous adipose tissue of women with PCOS in comparison with     a control population matched on the basis of age and body mass index (BMI). A secondary aim     was to then relate these gene expression profiles to the biochemical environment.   "
159558|NCT01195129|"     The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil     aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.   "
159559|NCT01195116|"     The purpose of this study is to assess the effects of dexmedetomidine while patients undergo     treatment for Interstitial Cystitis (IC). The investigators goal is to demonstrate in     patients with IC undergoing bladder hydrodistension that the use of dexmedetomidine as a     supplemental anesthetic agent will result in better postoperative pain management.   "
159560|NCT01195103|"     How does Lusedra compare with current standard of care (midazolam) for minimal to moderate     sedation for regional anesthesia blocks prior to orthopedic surgery?   "
159561|NCT01195090|"     This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with     pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite     dual therapy with metformin and a sulfonylurea.   "
159562|NCT01195077|"     Drawing inferences from epidemiologic studies of HIV/AIDS as well well as cell culture and     animal studies of HIV inhibition by algae, we propose algal consumption as one unifying     characteristic of countries with anomalously low rates. HIV/AIDS incidence and prevalence in     Eastern Asia (<1/10,000 adults in Japan and Korea), compared to Africa (≈1/10 adults)     strongly suggest that differences in IV drug use and sexual behavior are insufficient to     explain the 1000-fold variation. Even in Africa, AIDS/HIV rates vary. Spirulina is part of     the daily diet for many people living in Chad, where prevalence of HIV has remained at less     than 4% for more than 20 years. Average daily algae consumption in Asia and Africa ranges     between 1 to 2 tablespoons (3 - 13 grams).      HIV viral load is the main indicator of infection, however CD4 helper cell counts are most     predictive of morbidity and mortality.We hypothesized that the consumption of algae could be     important in diminishing the risk of HIV infection, and subsequent progression, possibly by     enhancing the immune response.   "
159563|NCT01195064|"     The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary     disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function,     before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a     cardiovascular surgery, by an observational physiological study.      An interim analysis will be performed when 100 patients will be included.   "
159564|NCT01195051|"     This study addresses the problem of inadequate medication reconciliation as patients cross     boundaries between inpatient and outpatient care (ambulatory care). The purpose of this study     is to determine whether a new, computer-based application, integrated with electronic     prescribing, improves erroneous discrepancies between pre-hospital medications and     medications upon patients' return to ambulatory care.   "
159565|NCT01195038|"     The study is designed to assess the immunogenicity and safety of one booster vaccination with     45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young     adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1     influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).   "
160083|NCT01188174|"     The present trial will establish a prospective sequential Allogeneic Stem Cell     Transplantation (allo-SCT) treatment combining both salvage chemotherapy and Reduced     Intensity Conditioning (RIC) for primary treatment failure Acute Myeloid Leukemia (AML), to     which future innovative strategies can be compared.   "
159566|NCT01195025|"     Volume kinetics is a method mostly used, so far, to study the distribution and elimination of     crystalloid solutions. Voluven (in Sweden the most commonly used colloid for replacement of     bleeding during surgery) is poorly studied, though. Also, a recent study showed unexpected     volume kinetics for a crystalloid solution when it was given after a colloid solution. The     investigators aim to study the volume kinetics of crystalloids and colloids and also the     combination of the two in more detail. The investigators will also compare the invasive     hemoglobin measurements with measurements from a new non-invasive tool (Radical 7, from     Masimo Inc.) which could help to make volume kinetics more practical for everyday use.     Finally the investigators will also study the concentrations of a few coagulation factors to     see if they can explain the variations in coagulability that has been described in earlier     studies of infusion solutions.   "
159567|NCT01195012|"     This is a feasibility study to evaluate a 6-month obesity treatment intervention (Helping     HAND: Health Activity and Nutrition Directions) for pediatric primary care clinics. The     program targets 5-8 year old children and their parents to change the child's lifestyle     behaviors and the associated parenting practices to improve the child's weight status. Four     community clinics participated. Families were recruited from clinics and after informed     consent and baseline data have been obtained, the families were randomized into one of two     groups: (1) the treatment group who immediately participated in Helping HAND or (2) the wait     list control group, who started the program 7 months later. Data were gathered on all the     participating children and their parents at three time points: baseline, post the     intervention (month 7) and post the wait list control group completing the intervention     (month 14).      This was a pilot study to test the feasibility of an obesity prevention plus program     delivered in the child's primary care clinic. The primary outcome was family attendance to     the 3 data-collection meetings with research staff and the 6 prevention plus intervention     sessions with a trained Health Advisor.   "
160782|NCT00000219|"     The purpose of this study is to examine the effects in buprenorphine dose alterations in     opioid dependent individuals being maintained on buprenorphine.   "
159568|NCT01194999|"     Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by     strenuous events such as child birth. A common purported side effect of PVS is urgency, the     feeling of a compelling need to void with little warning. Other overactive bladder (OAB)     adverse effects that some claim to develop post-op include further leakage (incontinence),     frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however,     suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be     alleviated by said procedure. It is our aim to investigate this relationship in our clinic.      As a prospective member of this study, you will be asked to complete five surveys. The first     survey will be administered prior to your pubovaginal sling. This will be used to establish     your baseline experience of OAB. Over the course of the next year, you will be asked to     complete the four remaining surveys at regularly scheduled check-ups.   "
159569|NCT01194986|"     The purpose of this study is to investigate features of radioligand [11C]AZ12807110 and how     much AZD5213 displaces radioligand from histamine receptors when given together.   "
159570|NCT01194973|"     The record Primary purpose is to assess the efficacy of eculizumab in adult patients with     Atypical Hemolytic- Uremic Syndrome (aHUS) to control Thrombotic Microangiopathy (TMA) as     characterized by thrombocytopenia, hemolysis and renal impairment.   "
159571|NCT01194960|"     Based on both pre-clinical and clinical data, it may be advantageous to administer a cancer     vaccine before chemotherapy to enhance immune responses, thus leading to a more effective     therapeutic approach for subjects with metastatic HRPC. This clinical study will evaluate the     role of combination therapy of TroVax® plus Docetaxel vs. Docetaxel alone on the progression     free survival (PFS) of subjects with HRPC.   "
159572|NCT01194947|"     Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct     subsets of melanocytic nevi that retain their distinctive pattern over time.   "
159573|NCT01194934|"     This is the second clinical study of NOX-A12. This study intends to provide information on     the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated     intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d) alone and to compare the mobilization of     hematopoietic stem cells (HSC) obtained with NOX-A12 alone with that obtained in combination     with filgrastim in healthy subjects. A single center, open-label, repeated dose study design     is selected to best address the study objectives.The results from this study will establish     the basis for further development of NOX-A12 in lymphoma patients undergoing autologous     hematopoietic stem cell transplantation   "
159574|NCT01194908|"     Patients are being asked to take part in this study because they have metastatic breast     cancer that is triple negative (does not express estrogen receptor (ER), progesterone     receptor (PR) or HER2). This means that agents such as trastuzumab (Herceptin®) and tamoxifen     are not currently treatment options for their cancer. Another option for treating the     patient's cancer at this point is with chemotherapy. The patient should discuss this and     other options with their doctor prior to entering this study.      Laboratory studies have demonstrated that ER is actually present in some triple negative     breast cancers but is silenced (does not function properly) because methyl and histone     groups are attached to it and inactivate it. Special drugs called demethylating inhibitors     (such as decitabine) and histone deacetylase inhibitors (such as LBH589) can remove these     methyl and histone groups and reactivate ER. This reactivated ER can then be targeted with     agents like tamoxifen.      The patient is being asked to join this clinical research study to find out if ER can be     reactivated in their cancer using decitabine in combination with LBH589. If ER is reactivated     in their cancer, we will then determine if tamoxifen can decrease the growth of the cancer.   "
159575|NCT01194895|"     The purpose of this trial is to determine whether low tidal volume during intraoperative     one-lung ventilation could decrease the incidence rate of postoperative acute lung injury     compared to normal tidal volume.   "
159576|NCT01194882|"     Primary Objective:      To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump     refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess     efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml     group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative     phase).      Secondary Objective:      To assess efficacy, safety, refill accuracy evolution and device interventions during the     open-label treatment period with Insuman To evaluate daily insulin doses To assess     Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases   "
159579|NCT01194843|"     The purpose of the study is to evaluate the efficacy and impact on morphine consumption of     ropivacaine administered by local per and post hepatic surgery infiltration.      Patients will be randomized to either ropivacaine or physiological serum, with equivalent     administration modalities in both arms.      Patients will be followed during 4 days after the surgery. They will also come back for a     follow-up visit one month later.      It is necessary to enrol 100 patients. The estimated period of inclusion is 24 months.      This is a prospective, comparative, monocentric, double-blind randomized study.   "
159580|NCT01194830|"     Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT     sub-study   "
159581|NCT01194817|"     The purpose of this study is to compare the the Nexgen knee replacement system using     cementless fixation with the same system using cemented fixation. At minimum 2-year     follow-up, the hypothesis is that NexGen total knee arthroplasties using cementless and     cemented fixation will demonstrate no differences in clinical outcome based on Oxford and     Knee Society scores, patient-assessed visual analog pain, clinical complications,     radiographic fixation and implant survivorship.   "
159582|NCT01194804|"     The objective of this study is to assess the long term safety of Eculizumab in hemolytic PNH     patients who completed the 4 weeks screening and 12 weeks treatment period of C07-001 study.     In addition, pharmacokinetic and pharmacodynamic assessments of Eculizumab will be conducted.   "
159583|NCT01194791|"     Primary outcome measure:      - Hematologic response rate to the association of Lenalidomide, Cyclophosphamide and     Dexamethasone.      Secondary outcome measures:        -  Organ response rate.        -  Predictors of response (cardiac biomarkers, serum free light chains).        -  Toxicity        -  Safety (type, frequency, severity and relationship of adverse events to the study drug).        -  Duration of response.        -  Time to progression.        -  Overall survival   "
159584|NCT01194778|"     Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green     vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher     menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Nothing is known yet     about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of     essential proteins). Therefore, this study was undertaken to study effects of different     dosages of bacterial vitamin K2 on carboxylation of extrahepatic proteins.   "
159585|NCT01194765|"     Anxiety disorders are common pervasive conditions with serious psychosocial implications.     Anxiety sensitivity (AS) is one individual characteristic that has been implicated in the     onset and maintenance of anxiety disorders (Schmidt et al., 1999). AS is an enduring fear of     anxiety-related arousal sensations (i.e., increased heart rate) that arises from the tendency     to interpret these sensations catastrophically, believing that they will have serious     physical, psychological, or social consequences (Reiss, 1991).      Research has shown the efficacy of CBT in decreasing AS among women with high AS (Watt et     al., 2006). Unfortunately, access to effective psychological treatments is limited by a     number of barriers such as a lack of treatment availability or qualified clinicians in an     area. As such, we are conducting a randomized controlled trial (RCT) of the effectiveness of     a distance-based CBT program on decreasing AS among those with high AS. A distance delivery     approach (e.g., via telephone) is one way to minimize treatment barriers and increase access     to care while still delivering empirically supported treatment. Recent research suggests     distance delivery is promising (Lovell et al., 2006).      The RCT will consist of an eight-week structured CBT program based on Watt and Stewart's     (2008) brief CBT for AS. The program will include weekly modules on psychoeducation,     cognitive restructuring, interoceptive exposure, and relapse prevention. Participants with     high AS will be recruited and randomly assigned to the treatment condition or wait-list     control (after twelve weeks the wait-list group will receive treatment). In the treatment     condition, participants will be assigned weekly reading and homework from the treatment     manual. In addition, a therapist will guide them through the treatment by providing     individualized support and feedback through weekly half-hour telephone sessions. Treatment     outcomes will be assessed through changes in AS levels and anxiety symptoms pre- to     post-treatment. Also, participants' satisfaction with the mode of treatment delivery will be     assessed. We hypothesize that this treatment program will be effective in reducing high AS     and anxiety symptom frequency and severity. We also expect this project to yield information     about the utility of distance treatment delivery for mental health care.   "
159586|NCT01194154|"     This randomized, single-blind, proof-of-concept study will investigate the protective effects     of early treatment with Mircera in participants with chronic kidney disease on renal disease     progression. Participants will be randomly assigned to receive 30 microgram (mcg) Mircera as     subcutaneous injection once monthly or matching placebo. Depending on change of hemoglobin     values, the dose of Mircera can be adjusted to 50 mcg or 75 mcg once monthly. The anticipated     time on study treatment is 24 months.   "
159587|NCT01194141|"     Barth syndrome (BTHS) is a genetic disease that results in heart failure, muscle weakness and     exercise intolerance. Several studies in non-BTHS heart failure suggest that endurance     exercise training is beneficial in improving exercise intolerance, heart function and quality     of life in young men with BTHS. This study will examine the effects of Endurance (i.e.     aerobic) exercise training on exercise tolerance, heart function, and quality of life in     adolescents and young adults with BTHS. We hypothesize that 3 months of endurance training     will improve exercise tolerance, heart function and quality of life in adolescents and young     men with BTHS.   "
159588|NCT01194128|"     This study will assess the effects of an intervention targeting family caregivers who     recently placed a relative in a long-term care facility because of cognitive and/or physical     disability. In a two group randomized clinical trial we predict that caregivers assigned to     active treatment will have lower levels of depressive symptoms, anxiety symptoms, and greater     satisfaction with the long-term care facility when compared to individuals assigned to the     control condition.   "
159589|NCT01194115|"     The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour     course of broad spectrum antibiotics prevents wound infection complications in patients that     are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women     undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a     prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of     normal vaginal flora will decrease the rate of surgical site infection in obese patients that     are at a greatly increased risk of postoperative infections complications.   "
159590|NCT01194102|"     The purpose of this study is to evaluate whether persons with stroke participating in a     12-week community based wellness program for persons who have had a stroke, experience     improved mobility (6 Minute Walk Test), balance, (The Short Portable Performance Test and     Timed Up and Go), strength (JAMAR hand grip dynamometry), level of physical activity (Rapid     Assessment of Physical Activity), reintegration in community (Reintegration into Normal     Living Index), self efficacy (Patient Activation Measure) and Quality of Life (Stroke     Specific Quality of Life Scale) compared to persons who do not participate in the program.   "
159591|NCT01194089|"     This prospective, randomized, double-blind study will enroll nonsmoking female subjects     undergoing laparoscopic bariatric surgery under general anesthesia. The hypothesis of this     study is that female nonsmokers who receive nicotine via nasal spray immediately before     waking up from anesthesia will need less pain medications 24 hours after the surgery compared     to the subjects who receive placebo spray.   "
159592|NCT01194076|"     The purpose of this study is to examine how well intensive cognitive-behavioral therapy (CBT)     delivered over 5 days works in reducing Obsessive-Compulsive Disorder (OCD) symptoms in     children and adolescents. Treatment will consist of exposure and response prevention with an     added focus on teaching parents to be exposure coaches.   "
159593|NCT01194063|"     Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.   "
159594|NCT01194050|"     This observational study will investigate the tolerability and efficacy of Tarceva     (erlotinib) in daily clinical practice under routine conditions in patients with locally     advanced or metastatic non small cell lung cancer. Data will be collected for approximately     12 months.   "
159595|NCT01194037|"     The primary objective of this study is to evaluate the safety and tolerability of ascending     doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this study     is to define the PK and PD of ascending doses of Hanferon™ in combination with RBV. The     exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy     in combination with RBV.   "
159596|NCT01194024|"     The goal of this multicenter study is to develop a standardized scoring system for inhalation     injury that can be used both to quantify and predict injury severity inhalation injury in     adults over 18 years of age. A model will be developed based on clinical, radiographic,     bronchoscopic, and biochemical parameters that will predict the severity of inhalation injury     with greater than 80% predictive accuracy   "
159597|NCT01194011|"     Research objectives To provide people with sufficient information regarding health care and     to improve its quality, this research endeavors to discuss the establishment of a health care     information openness and transparency mechanism within the framework of the National Health     Insurance system. This research also evaluates whether the transparency of health care     quality information makes care givers provide better quality. Meanwhile, when appropriate     information and quality index are presented to patients, patients shall have more knowledge     about what they are dealing with, hence less misunderstanding between hospitals and patients     would occur.      Research Methods        1. To revise indicators based on international trends, related literature and the need of          people.        2. To present 50 sets of quality indicator statistically on the website, and provide          updated information about the first 10 sets.        3. To analyze and explain the outcome and purposes of the indicator to the public.        4. To estimate the possible trend for the coming year, and provide adaptive strategy.        5. To promote the website, and hold workshops in all six regions of Taiwan.        6. To make the website linked to the top 5 most populated official and unofficial websites.        7. To respond to questions on the forum of the website daily, and maintain the system,          update the website regularly.        8. To complete the acceptability survey on health care institutions and people.   "
159598|NCT01193998|"     The purpose of this study is to evaluate a validated diagnostic prediction model in the     appropriate diagnosis of Acute Heart Failure (AHF) in patients presenting at the emergency     department with undifferentiated dyspnea.   "
159599|NCT01194713|"     Introduction: Alzheimer's disease (AD) is characterized by neurodegeneration of the brain in     the form of neurofibrillary tangles and plaques containing the amyloid-beta protein (Abeta).     Recent animal studies have shown that extended wakefulness is associated with increased     production of these Abeta proteins and that sleep leads to a marked fall in their production.      Aim: The investigators aim to distinguish a similar effect of sleep disturbance on     cerebrospinal fluid (CSF) Abeta levels in humans, which may point out sleep disturbance as an     important factor in AD development.      Methods: a study in 26 healthy male volunteers, measuring CSF Abeta levels during a sleep     deprivation night and before and after a control night with unrestricted sleep.      Expected results: The investigators expect sleep deprivation to lead to an increase in CSF     Abeta levels, as compared to the levels in the control night.   "
159600|NCT01194700|"     The purpose of this study is to determine the effect of plastic spacers and breath actuated     spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and     whether electrostatic charge within plastic spacers has a clinically relevant impact on the     inhaled steroid delivery.   "
159601|NCT01194687|"     Background:      - Bacteria and other micro-organisms in the intestines play important roles in immunity and     other health conditions. As a result, these micro-organisms are likely to affect many health     conditions, including several types of cancer. Because cancer and other diseases may affect     the digestive system and the bacteria within it, fecal samples that are taken both before and     after the onset of a disease may show important changes in the body and provide information     about possible treatments. However, unlike repositories of blood and tissue samples,     researchers do not have a repository of fecal specimens. Researchers are interested in     determining whether standard collection procedures used for fecal occult blood testing can     provide accurate information on micro-organisms in the intestine.      Objectives:      - To determine whether standard fecal occult blood testing procedures can provide accurate     collections of fecal micro-organisms for research purposes.      Eligibility:      - Healthy volunteers at least 18 years of age.      Design:        -  At the clinical center, participants will be provided with written and illustrated          instructions for the collection procedures and a self-administered risk questionnaire.          The questionnaire will assess the challenges of collecting fecal specimens and will          collect data on major dietary restrictions (e.g., vegan, vegetarian, food allergies),          medication use and major illnesses, knowledge of and past experience with fecal occult          blood testing, colonoscopy and colon cancer, and the fecal collection devices.        -  Participants will be provided with a collection bag for the sample, 16 sample collection          tubes, and a box with frozen gel packs.        -  On the morning of collection, participants will collect the fecal sample in the bag and          use the collection tubes to obtain material from different parts of the stool.        -  The tubes will be sealed and placed in the box with the gel packs, and the participant          will hand deliver the entire box to the clinical center.        -  Characteristics of the bacteria in the material will be measured by laboratories at the          University of Maryland.        -  Statistical comparisons will determine how well the procedures worked.   "
159602|NCT01194674|"     The objective of this study is to investigate the safety and efficacy of microplasmin as a     treatment for uveitic macular edema.   "
159650|NCT01193881|"     This phase I trial studies the side effects and best dose of gamma-secretase/Notch signalling     pathway inhibitor RO4929097 (RO4929097) and erlotinib hydrochloride when given together in     treating patients with non-small cell lung cancer that is stage IV or has come back.     RO4929097 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth.   "
160893|NCT00000333|"     The purpose of this study is to compare the efficacy of benztropine (or DA reuptake     inhibitor) with atropine and placebo in affecting stimulated craving to cocaine cues.   "
159603|NCT01194661|"     Background:      - Previous research has shown that certain parts of the brain are involved in voluntarily     stopping an ongoing motor response (movement); however, it is not known whether this same     network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can     significantly impair the brain's ability to voluntarily stop or inhibit certain actions.     Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation     (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that     involve moving and suppressing movements, researchers hope to better understand how these     brain areas might be affected in people who have had TBI.      Objectives:        -  To determine the parts of the brain involved in suppressing an urge to act.        -  To determine the extent to which traumatic brain injury affecting certain parts of the          brain is involved in problems with suppressing an urge to move and stopping movement.      Eligibility:      - Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy     volunteers.      Design:        -  This research study includes a screening visit and two study visits, each of which will          last at least 2 hours.        -  Participants will be screened with a physical examination and medical history. Women who          can become pregnant will have a urine pregnancy test before being allowed to participate          in the study.        -  At the first study visit, participants will complete one of the following experiment          tests in an MRI scanner.        -  Experiment 1: Participants will be shown arrows or images on a computer screen, and will          press a button or not press a button depending on the image shown. Participants will          practice the experiment tasks before performing them during MRI scans.        -  Experiment 2: Participants will be shown arrows or images on a computer screen, and will          press a button or not press a button depending on the image shown. Participants will          also have TMS while at rest, and will perform the experiment tasks during the MRI scan.        -  At the second study visit, participants will have an fMRI scan where they will be asked          to do simple response tasks with a computer outside the MRI scanner.      Background:      - Previous research has shown that certain parts of the brain are involved in voluntarily     stopping an ongoing motor response (movement); however, it is not known whether this same     network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can     significantly impair the brain's ability to voluntarily stop or inhibit certain actions.     Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation     (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that     involve moving and suppressing movements, researchers hope to better understand how these     brain areas might be affected in people who have had TBI.      Objectives:        -  To determine the parts of the brain involved in suppressing an urge to act.        -  To determine the extent to which traumatic brain injury affecting certain parts of the          brain is involved in problems with suppressing an urge to move and stopping movement.      Eligibility:      - Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy     volunteers.      Design:        -  This research study includes a screening visit and two study visits, each of which will          last at least 2 hours.        -  Participants will be screened with a physical examination and medical history. Women who          can become pregnant will have a urine pregnancy test before being allowed to participate          in the study.        -  At the first study visit, participants will complete one of the following experiment          tests in an MRI scanner.        -  Experiment 1: Participants will be shown arrows or images on a computer screen, and will          press a button or not press a button depending on the image shown. Participants will          practice the experiment tasks before performing them during MRI scans.        -  Experiment 2: Participants will be shown arrows or images on a computer screen, and will          press a button or not press a button depending on the image shown. Participants will          also have TMS while at rest, and will perform the experiment tasks during the MRI scan.        -  At the second study visit, participants will have an fMRI scan where they will be asked          to do simple response tasks with a computer outside the MRI scanner.   "
159604|NCT01194648|"     RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by     heating them without affecting normal tissue.      PURPOSE: This phase II trial is studying high-intensity focused ultrasound in treating     patients with localized prostate cancer.   "
159605|NCT01194635|"     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors understand how patients respond to     treatment.      PURPOSE: This research study is studying biomarkers of response in blood and tumor tissue     samples from patients with unresectable stage IV squamous cell carcinoma of the head and neck     previously treated with cetuximab, cisplatin, and radiation therapy.   "
159606|NCT01194622|"     The primary objective is to assess the effect of azelastine hydrochloride (AZE) on the     relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed     AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE     (i.e. FLU alone in the MP29-02 vehicle; REF).      The secondary objectives are to compare the relative bioavailability (AUC0-∞) of FLU when     administered either as fixed AZE-FLU combination product (TEST) or as marketed FLU product,     Fluticasone Propionate Nasal Spray, Roxane Laboratories (COMP); To compare the effects of AZE     on other pharmacokinetic parameters of FLU (AUC0 tlast, CL/f, Cmax, tmax, t½); To assess     adverse events.   "
159607|NCT01194609|"     Among the immune cell therapy, autologous adoptive immune cell therapy is a method to     transfer the immune cells derived from peripheral white blood cells and expanded and     stimulated with various cytokines and tumor specific antigens in cancer patients. Recently,     the low-dose radiation is known to increase the immune response in many human cancer     patients. In a clinical trial, 70% response rate with combination of low-dose radiation and     adoptive immune cell therapy was reported in recurrent melanoma patients. This study is to     investigate the feasibility of combination of low-dose radiation and autologous immune cell     therapy in recurrent cervical cancer which is resistant to conventional palliative treatment.   "
159608|NCT01194596|"     The purpose of this study is to evaluate the effectiveness of the spirometric results     information advice about the smoking habit the investigators designed an intervention trial     in primary care.      Hypothesis: In adult smokers, smoking cessation advice combined with a discussion of the     spirometric tests on the part of the practitioner achieves a higher rate of tobacco reduction     and abandonment than just smoking cessation advice.      Expected results: In adult smokers, a detailed discussion of the results yielded by     spirometry tests together with brief smoking cessation advice on the part of the primary care     practitioner can facilitate tobacco reduction and abandonment.   "
159609|NCT01194583|"     The study's major aim is to investigate the ability of a commercial Electronic Nicotine     Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers     unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and     cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe. The     study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and     adverse events of a currently marketed device in Italy (Categoria electronic cigarette -     NO nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device     that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal     symptoms and cravings independently from nicotine delivery.   "
159610|NCT01194570|"     This randomized, parallel group, double-blind, placebo controlled study will evaluate the     efficacy and safety of ocrelizumab in participants with primary progressive multiple     sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or     placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label     Extension (OLE) treatment for participants in both groups who in the opinion of the     investigator could benefit from further or newly initiated ocrelizumab treatment. Unless     terminated early, all participants will continue their treatment with open-label ocrelizumab     until the last participant who entered the OLE phase reaches 4 years of open-label     ocrelizumab treatment.   "
159611|NCT01194557|"     Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor     access to health facilities, home management of malaria (HMM) can improve the timeliness of     treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and     impact, artemisinin combination therapies (ACTs) should be deployed in HMM programmes, as     well as in formal health facilities. Up to 80% of malaria cases are treated outside the     formal health sector and shops are frequently visited as the first (and in some cases only)     source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role     of shops in home management and to ensure that drugs sold are appropriate. The current     practice of presumptive treatment of any febrile illness as malaria (both at health     facilities and in the context of HMM) based solely on clinical symptoms without routine     laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT     being a more costly regimen, it is important to be more restrictive in its administration and     rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in     remote locations lacking electricity and qualified health staff.      This study therefore proposes to evaluate the feasibility, acceptability, and     cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by ocal drug     shops in an area with high malaria transmission.   "
159612|NCT01194544|"     Gastroesophageal reflux disease (GERD) is commonly seen in Western countries; however, it is     gaining prevalence in Asia countries recently. In addition to the lower esophageal sphincter     and the crural fibers of the diaphragm, the flap valve at the gastroesophageal junction is     also responsible for maintaining an antireflux barrier. Hill et al developed a grading system     of gastroesophageal flap valve (GEFV) and concluded that this flap valve system is simple,     reproducible, and offers diagnostic aid in the evaluation of patients with suspicious reflux     disease undergoing esophagogastroduodenoscopy (EGD). It is a common belief that large meals     provoke considerable postprandial reflux and it results from an increase in the rate of     transient lower esophageal sphincter relaxations. One study also revealed that rapid food     intake produces more gastroesophageal reflux in healthy volunteers. So this study attempted     to evaluate the relationship between dietary habit and GEFV abnormality. The investigators     used a questionnaire regarding the dietary habit to the population undergoing EGD in a     self-paid health examination.   "
159623|NCT01194401|"     This prospective, multi-center observational study will assess the long-term efficacy and     safety of RoActemra/Actemra in daily practice in patients with active moderate to severe     rheumatoid arthritis who have an inadequate response or are intolerant to one or more     disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.     Data will be collected from patients initiated on RoActemra/Actemra treatment according to     label by decision of the treating physician. Anticipated time for data collection from each     patient will be 2 years.   "
159624|NCT01194388|"     The current observational evaluation is designed to evaluate the performance of the Axium™     MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life     practice.   "
159625|NCT01194375|"     The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in     treating patients with acne vulgaris.   "
159613|NCT01194531|"     Natera is recruiting patients for a research study evaluating pregnancy and implantation     rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening     (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy.      Healthy women undergoing IVF who are between the ages of 35 to 42 years are being recruited     to participate in a randomized study.      The purpose of this study is to determine whether PGS- testing of embryos created during IVF     for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and     implantation rates in patients when compared to patients whose embryos are not tested. PGS     will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Natera.      All subjects who qualify and enroll will receive discounted IVF medications (both TEST and     CONTROL arms). If you become pregnant during the study, you will receive a small payment for     providing information about your pregnancy and birth. If you are assigned to the TEST arm of     the study you will receive free PGS.   "
159614|NCT01194518|"     The lifestyle consulting program through one year follow-up could effective increase the     scores of health responsibility and nutrition according to the past three-year study.     Behavior change is a dynamic and complex process. Using a long-term follow up approach will     be able to understand the trajectory of behavior change. The purpose of this study is to     explore life experience and lifestyle intervention program for patients with chronic kidney     disease using mixed methods with a longitudinal approach. The first year of this study will     include a qualitative study with in depth interview of the subjects who attend previous study     in the research team and have the scores of health promoting lifestyle among the highest 27%     and lowest 27%. The life experience will be explored. The quantitative study will be an     experimental design. Qualified subjects will be randomly assigned to intervention or control     group. The intervention protocol is based on trans-theoretical model. Each subject will be     followed every six months. The second and third year of studies will continue to use the     qualitative and quantitative approach to understand the life experience and meaning among     patients with chronic kidney diseases. The trajectory of life experience and life style     changes will be explored. The method may strengthen the effectiveness of lifestyle program     and may provide comprehensive understanding of the trajectory of behavior changes among     patient with chronic kidney disease.   "
159615|NCT01194505|"     Anterior Cruciate Ligament ACL reconstruction can be performed under the combination of     posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same     outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks.     More specifically under the combination of sciatic nerve block plus femoral nerve block plus     obturator nerve block.   "
159616|NCT01194492|"     The purpose of this study is to determine whether the kinetics of endogenous albumin is     altered by the generalized inflammation caused by major abdominal surgery.   "
159617|NCT01194479|"     Insulin treatment often causes the blood glucose levels to fall too low. The body usually     responds to low blood glucose levels by releasing hormones which act against the insulin to     help correct the low blood glucose levels. However, this hormone response can be altered in     people with diabetes. Currently there are no therapeutic agents that can be used to improve     the recovery from hypoglycemia (low blood sugar). The aim of this study is to determine     whether a formoterol inhaler can be used to improve and accelerate the recovery from     hypoglycemia in patients with type 1 diabetes.   "
159618|NCT01194466|"     The overall goal of this study is to examine the effect of a single dose of TENS on mucositis     pain and function secondary to head and neck radiation therapies. Oral mucositis is an     extremely debilitating, unpreventable condition (inflammation, ulcers, bleeding in the mouth,     nose, and throat) that causes significant pain, functional impairment, and diminished quality     of life. Head and neck cancers pose specific challenges to effective pain management and past     studies suggest the use of effective non-pharmacologic strategies such as TENS may be     particularly beneficial for avoiding sources of acute and chronic pain, thereby improving     quality of life. The investigators hypothesize that a single dose of TENS will decrease pain     and improve function and quality of life in head and neck cancer patients. This project is     particularly innovative because it is the first known study to examine the efficacy of TENS,     an established safe, inexpensive and easy-to-use non-pharmacologic pain management     intervention, for treating acute oral mucositis pain. The investigators research translates     bench (animal model) science to human subjects using an interdisciplinary approach to pain     management. Establishing whether TENS is effective for reducing mucositis pain is a critical     first step toward establishing an effective, non-pharmacologic pain relief intervention for     mucositis.   "
159619|NCT01194453|"     A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC)     cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient     administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences     based on histologic type. The investigators want to research some biomarkers that can predict     clinical outcomes.   "
159620|NCT01194440|"     RATIONALE: Zoledronic acid may prevent bone loss and help prevent or lessen musculoskeletal     symptoms in women receiving hormone therapy for breast cancer.      PURPOSE: This phase II trial is studying how well zoledronic acid works in preventing     musculoskeletal symptoms in post-menopausal women with stage I, stage II, or stage III breast     cancer receiving letrozole.   "
159622|NCT01194414|"     This randomized, double-blind, parallel group study compares the efficacy and safety of     subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with     moderate to severe active rheumatoid arthritis. Participants were randomized to receive     either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv     every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24.     The double-blind period was followed by a 72-week open-label treatment with some switching of     sc and iv administration. No placebo was administered in the open-label phase. Participants     continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout     the study. Anticipated time on study treatment was 2 years.   "
159626|NCT01194362|"     For this study, blood and tissue samples will be collected in order to perform genetic     testing to help researchers gather information about this disease and how and why it affects     some patients more than others.   "
160783|NCT00000220|"     The purpose of this study is to determine an optimal detoxification dose reduction schedule     with buprenorphine.   "
159629|NCT01194323|"     GERD is a common condition in the western world. In most cases, the diagnostic is established     by good response to empiric proton pump inhibitor (PPI) therapy. When the patient symptoms     are refractory to therapy, multiple invasive tests are available. The results of those tests     (EGD, manometry, Ph monitoring and impedance) are clues that the physician use together to     establish the diagnostic. No test however can be use alone because of their poor specificity     and sensitivity. Recently, microscopy has been used to detect dilated intercellular space in     between distal esophageal cells tissue; unfortunately this marker again failed to diagnose     GERD.      In search of more sensitive and specific markers of GERD, we propose to assess if acid     exposure affects: 1) gene and proteins expression in the esophageal/post-cricoid area tissue;     and 2) local impedance of the mucosa. The secondary aim of this proposal is to determine if     correlation exists between the two approaches.   "
159630|NCT01194310|"     This study compares efficacy (i.e. IOP and hypotensive medications) of phaco alone vs.     combined phaco plus excimer laser trabeculotomy vs. combined phaco plus trabectome.   "
159631|NCT01194297|"     Severe influenza respiratory disease is increasingly recognized in children. Influenza     hospitalization rates in high-risk infants, such as premature infants, are increased some     five-fold over rates in other children. The recently-licensed live attenuated influenza     vaccine (LAIV) promotes better immune responses than the trivalent inactivated vaccine, but     can cause wheezing. The balance of risks and benefits for LAIV in extremely premature     infants, who may be at increased risk for both influenza disease and vaccine side effects, is     unknown.      The specific aim of this project is to compare the immune response and reactions of     trivalent, inactivated influenza vaccine (TIV) and live, attenuated, intranasal influenza     vaccine (LAIV) in groups of former premature (PT), very (V) LBW and former full-term (FT)     infants aged 24-35 months.      The investigators hypothesize that the immune response in FT infants will be greater with     LAIV than TIV, and that wheezing episodes will be no more than twice as frequent in LAIV as     in TIV recipients.      The study will enroll 14 former premature, VLBW infants and 14 former full-term infants.     Children will be randomized to receive one dose either TIV or LAIV. Vaccine reactions will be     measured. One to two teaspoons mL of blood will be drawn at 0 and 7-14 days from     immunization, and less than one teaspoon of blood will be drawn at 28-42 days.   "
159632|NCT01194284|"     This study is an observational safety surveillance study designed to prospectively assess     patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide     within the context of prevailing standard oncology practice   "
159633|NCT01194271|"     The goal of this clinical research study is to learn how ipilimumab in combination with     Lupron (leuprolide acetate) affects the body's own defense (immune) system before having     surgery to remove prostate cancer. The safety of the drug combination will also be studied.   "
159634|NCT01194258|"     The purpose of the study was to compare Humalog (insulin lispro)-recombinant human     hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the     treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.   "
159635|NCT01194245|"     The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human     hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for     the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.   "
159651|NCT01193868|"     This phase II trial is studying how well RO4929097 works in treating patients with advanced     non-small cell lung cancer who have recently completed treatment with front-line     chemotherapy. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.   "
159652|NCT01193855|"     RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This randomized phase II trial is studying how well giving dutasteride works in     treating patients with prostate cancer.   "
159636|NCT01194232|"     Cystic Fibrosis (CF), the most common inherited disease in Caucasians, is characterized by     chronic pulmonary inflammation and progressive loss of gas exchange units that eventually     results in respiratory failure. There is strong evidence that, in CF, abnormally low     perfusion carries a high risk of death independent from the presence of pulmonary     hypertension. However, the evolution of pulmonary vascular disease in CF and how it might     contribute to the rate of decline in lung function is not known. Our knowledge remains     limited to the results of old observational studies which concluded that the major causes of     pulmonary vascular remodeling and hypertension in CF are hypoxic respiratory failure and     destruction of lung tissue. Our recent data obtained by state-of-the-art Magnetic Resonance     Imaging (MRI) of the pulmonary circulation, challenges the existing paradigm. We demonstrate     that in the absence of hypoxia, significant changes in pulmonary perfusion and in surrogate     measures of vascular resistance as well as in collateral blood flow begin early in the course     of CF. Newly developed therapeutics have altered dramatically the course of patients     suffering from pulmonary vascular disease. Through this 8 week trial, we will examine by     Magnetic Resonance Imaging the effect of Sildenafil on pulmonary perfusion and systemic     vascularization of the lungs in subjects with mild to moderate disease.   "
159637|NCT01194219|"     This study evaluated the effects of an called apremilast. Apremilast works by lowering some     of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The     purpose of this study was to test apremilast and compare its effects to placebo (an inactive     substance which contains no medicine but is in the same form as the drug). This study was     able to test for efficacy (improvement of signs and symptoms) and safety of apremilast in     patients with moderate to severe psoriasis.   "
159638|NCT01194206|"     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Stereotactic body     radiation therapy may be able to send x-rays directly to the tumor and cause less damage to     normal tissue in patients with liver cancer. Giving stereotactic body radiation therapy may     also increase patient eligibility for liver transplant.PURPOSE: This phase II trial is     studying how well stereotactic body radiation therapy works in treating patients with liver     cancer that cannot be removed by surgery or transplant.   "
159639|NCT01194193|"     To investigate the safety and tolerability of AZD8055 intermittent dosing schedules when     given orally to patients with advanced solid malignancies and lymphomas. Two intermittent     dosing schedules will be explored with increasing doses until a maximum tolerated dose is     determined for each schedule.   "
159640|NCT01194180|"     The purpose of this study is to evaluate the BCG 'challenge' model a four-arm study design     has been chosen. Twelve subjects will be recruited into each arm of the study. Allocation of     BCG-naïve volunteers to either group A or B, and BCG-vaccinated volunteers to either group C     or D, will be performed on a one-to-one alternating basis. Subjects in each group will be     challenged by BCG administered intradermally. Prior to challenge, pre-existing immunity to TB     will be induced by vaccination with BCG, MVA85A, and both in combination (when compared to     BCG- & MVA85A-naïve individuals). BCG quantification will be assessed by analysing the tissue     obtained in a punch biopsy of volunteers' skin over the site of BCG 'challenge' vaccination.     Any reduction in BCG quantification between groups will then be correlated to existing (and     future) laboratory assays of vaccine-induced immune responses in order to identify potential     immunological correlates of protection.   "
159641|NCT01194167|"     This phase II trial is studying the effects of the drug eltrombopag has on thrombocytopenia     (low platelet count). Eltrombopag is approved by the FDA for the treatment of     thrombocytopenia (low platelet count) in adults who have had an insufficient response to     medications such as corticosteroids and immunoglobulins. Eltrombopag is not approved by the     FDA (Food and Drug Administration) for the treatment of thrombocytopenia refractory to     platelet transfusion and so for this study is considered investigational.   "
159642|NCT01193985|"     This an open, uncontrolled multicenter clinical study to assess the safety and performance of     the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.      The primary objective is to determine the safety of the WK-6 surgical mesh. Data will be     compared retrospectively with published studies on inguinal hernia mesh.      The secondary objectives are to explore the performance of the surgical mesh by measuring the     pain pre and post surgery as well as a number of relevant variables for establishing the     performance of the mesh. Data will be compared retrospectively with previous studies on     inguinal hernia mesh with a follow-up of at least one year.   "
159643|NCT01193972|"     A decision aid tool will be developed using participatory research approach. The decision aid     will be targeted to cigarette smokers scheduled for elective surgery.   "
159644|NCT01193959|"     Present study is aimed at investigating potential molecular predictors of sensitivity or     resistance to single-agent pemetrexed in the ≥ second line setting in a large cohort of     advanced non-small cell lung cancer (NSCLC) patients. The following biomarkers will be     investigated with either immunohistochemistry, fluorescence in situ hybridization or     genotyping: thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide     ribonucleotide formyl transferase (GARFT), aminoimidazole carboxamide ribonucleotide     formyltransferase (ATIC/AICARFT), epidermal growth factor receptor (EGFR), Kirsten rat     sarcoma 2 viral oncogene homolog (KRAS), v-myc myelocytomatosis viral oncogene homolog (MYC)     and phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA).   "
159645|NCT01193946|"     The purpose of this study is to evaluate dietary protein requirements in elderly women aged     80 years and older using the indicator amino acid oxidation technique.      Hypothesis to be tested: Protein requirement for elderly women is higher than the estimated     average requirement of 0.66 g∙kg-1∙d-1 protein. The recommended protein intake for elderly     women is higher than the recommended dietary allowance of 0.80 g∙kg-1∙d-1 protein.   "
159646|NCT01193933|"     1. evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the          efficacy of its substitution by dexamethasone if blast count is 25% and more        2. feasibility for adults of no interruptions protocol with 8 weeks induction and 14          weeks consolidation followed by 2-years maintenance.        3. tolerability and efficacy in adults of the prolonged L-asparaginase application (total          proposed dose 560.000 IU)        4. feasibility and efficacy of autologous stem cell transplantation for T-cell ALL   "
159647|NCT01193920|"     This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at     one dose in healthy non pregnant women and then in three different doses in healthy pregnant     women.   "
159653|NCT01193842|"     This partially randomized phase I/II trial studies the side effects and the best dose of     vorinostat when given together with combination chemotherapy and rituximab to see how well it     works compared to combination chemotherapy alone in treating patients with human     immunodeficiency virus-related diffuse large B-cell non-Hodgkin lymphoma or other aggressive     B-cell lymphomas. Vorinostat may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with     the ability of cancer cells to grow and spread. Giving vorinostat together with combination     chemotherapy and rituximab may kill more cancer cells.   "
159654|NCT01193829|"     1. To compare EGFR mutations between primary non-small cell lung cancer (NSCLC) tumours and          corresponding CTCs isolated by a label-free microfluidic device-based system        2. To characterize the association between clinical response in NSCLC patients treated with          gefitinib and serial changes in CTC EGFR mutations detected by a label-free microfluidic          device-based system      The investigators recently developed a label-free, microfluidic device for capturing     circulating tumour cells (CTCs) and acquired a Fluidigm Biomark digital PCR instrument for     reliable low-level DNA quantification. The overall aim of this study is to test the     feasibility of using these state-of-the-art devices to reliably detect clinically relevant     EGFR mutations in CTCs.   "
159655|NCT01193816|"     This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming     patients down in a situation of restlessness during mechanical ventilation weaning. This drug     is used for several years to quieten restless patients. Its purpose is to restore spontaneous     breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation.   "
159672|NCT01193595|"     Primary Objective:      - To determine the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of     ombrabulin in combination with best tolerated dose of bevacizumab based on the incidence of     related Dose Limiting Toxicities (DLTs).      Secondary Objectives:        -  To assess the overall safety profile of the combination        -  To characterize the pharmacokinetic (PK) profile of both ombrabulin and bevacizumab when          given in combination        -  To evaluate preliminary evidence of anti-tumor activity        -  To assess the pharmacodynamic effect using (Dynamic Contrast Enhanced Ultra-Sound)          DCE-US, measuring biomarkers   "
159656|NCT01193803|"     Osteoarticular infections are painful and disabling diseases that require antimicrobial     treatment adapted to the microorganisms implicated. Microbiological cultures are currently     regarded as the reference for identification of pathogenic bacteria. However, the sensitivity     of these cultures is very variable and depends both on the context in which clinical samples     are taken, and on the pathogen involved. The rate of detection varies according to infection     type: from 50 to 70% for infectious spondylodiscitis, 65 to 95% for prosthetic joint     infections, 50% for gonococcal arthritis and 90% for non-gonococcal arthritis. The aim of the     study is to evaluate the diagnostic performances of microbiological cultures and molecular     methods in case of osteoarticular infections. The gold standard will be established by an     expert group of osteoarticular infection (composed by a bacteriologist, a radiologist, a     surgeon, an anatomy-pathologist and a rheumatologist), which established the final diagnosis     of infected or not infected patients.   "
159657|NCT01193790|"     The investigators wish to evaluate coblation channeling in the treatment of chronic     tonsillitis.   "
159658|NCT01193777|"     Sepsis is a severe and overwhelming response to an infection in the body. Over 750,000     patients in the United States develop sepsis every year. As sepsis becomes progressively more     severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen     to the rest of the body, which is necessary for normal cell function. This is called septic     shock. When someone develops septic shock, it is very common for the smallest blood vessels     in the body called the microcirculation to clog, like a highway during rush hour. Even with     the best medical care, more than one in three patients with septic shock will die.      The major goal of this study is to test if intravenous replacement of a naturally occurring     nutrient that is lost by the body during sepsis called L-carnitine can reduce how sick a     patient with sepsis becomes. In our study, some patients will receive L-carnitine and others     will receive saline. We will measure markers determining severity of illness in both groups     and compare them to see if L-carnitine helps patients get better faster. Based on research     already conducted, we believe L-carnitine will improve blood flow in the microcirculation,     delivering more oxygen to cells, and help the body get better. To test if this is true, we     will directly look at the microcirculation under the tongue with a special magnifying camera     that looks at red blood cells, and compare both groups.   "
159659|NCT01193764|"     The investigators conducted a recent pilot study and found a strong positive correlation     between the consumption of 100% chocolate and acne exacerbation. However, this study had     limitations including the lack of placebo and the small sample size. Although studies have     been conducted assessing chocolate's effect on acne, no study has been done evaluating this     effect using chocolate with 100% cocoa content in a double blind placebo controlled fashion.     This study will analyze the difference in the number and type of acneiform lesions per     subject at the different time points (Day 4 and Day 7) compared to baseline in order to     increase the validity of the investigators results. In addition, the investigators will use     unsweetened cocoa powder,12 rather than chocolate candy, which contains higher quantities of     additive ingredients such as sugar and milk to avoid interference with the results and the     possibility to establish or not an association between the unsweetened cocoa and an effect on     acne.   "
159660|NCT01193751|"     The specified Apgar-Score in combination with the AAP-Score predicts the morbidity and     mortality of asphyxiated newborns.   "
159661|NCT01193738|"     The main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep     obstructive apnea syndrome (OSA).   "
159662|NCT01193725|"     This study is evaluating the efficacy of virtual realty exposure therapy (VRET)by comparing     it to prolonged exposure therapy (PE) and a waitlist (WL) group for the treatment of post     traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The     investigators will test the general hypotheses that 10 sessions of VRET or PE will     successfully treat PTSD, therapeutically affect levels of physiological arousal, and     significantly reduce perceptions of stigma toward seeking behavioral health services.   "
159663|NCT01193712|"     The purpose of this study is to determine whether left ventricular endocardial pacing     exhibits a greater acute hemodynamic response during biventricular pacing in patients who do     not show this response to standard cardiac resynchronization therapy.   "
159664|NCT01193699|"     The purpose of this study is the identification of the maximum tolerated dose (MTD) of the     investigational medicinal product. Moreover the safety and tolerability will be assessed and     an exploratory analysis of efficacy and biomarker modulation will be performed.   "
159665|NCT01193686|"     The goal of this study was to train OIF/OIF Veterans with multiple injuries to be Peer     Visitors, i.e., Volunteers who visit more recently OIF/OEF Veterans and provide support. We     evaluated the effectiveness of the training, and any benefits that Volunteer Peer Visitors     and the Recipients of Peer Visitors experienced as a result of participating in Peer     Visitation.   "
159666|NCT01193673|"     The primary objective of the study is to find the gene(s) responsible for causing DDH. The     secondary objective of the study is to determine the mode of genetic transmission of DDH.   "
159667|NCT01193660|"     This randomized control study is aimed to determine efficacy of umbilical cord blood and     erythropoietin combination therapy for children with cerebral palsy.   "
159668|NCT01193647|"     This study will begin to evaluate the heritability of rotator cuff disease, and begin     creation of a powerful resource for future genetic studies of rotator cuff disease.   "
159669|NCT01193634|"     The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features:      The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding     potential lost of capture.      Then, the ICD devices have also the capability to be remotely interrogated through the remote     monitoring system whose performances will be reported during the study.      Finally the study will report the electrical and handling performances of the new left     ventricular lead.   "
159670|NCT01193621|"     In the present study, the investigators will establish the clinical trial technology for     early evaluation of drug characteristics in terms of pharmacokinetics and pharmacodynamics     for haloperidol as a model drug, using positron emission tomography.   "
159671|NCT01193608|"     This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients     with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812)     or placebo. Each patient's participation will last approximately 41 weeks.   "
159674|NCT01193569|"     The objective of this study is to determine the natural history of acute ischemic stroke from     large vessel thromboembolism in the brain. The target population is a stroke cohort with a     known infarct volume who presents within 8 hours from symptom onset with a NIH Stroke Scale     (NIHSS) score >10 who are eligible for mechanical thrombectomy but without receiving the     treatment. Functional outcome as defined by the modified Rankin Scale (mRS) of all enrolled     patients will be followed for 90 days after the index event.   "
159675|NCT01193556|"     The objective of this clinical study is to evaluate the operative performance of the PEAK     PlasmaBlade® TnA during subcapsular tonsillectomy; to monitor and record post-operative     clinical outcome variables; and to compare these endpoints to the Standard of Care (SOC).   "
159676|NCT01193543|"     Preliminary studies in rats and mice indicate that calanus oil reduce accumulation of     intra-abdominal fat. Pilot studies in humans have shown no adverse effects. In the present     study 120 subjects, males and females, 20-65 years old, BMI 25-30 kg/m2 will be included and     given calanus oli 1 g twice daily versus placebo for 1 year. The hypothesis is that calanus     oil will reduce intra-abdominal fat, improve glucose tolerance and lipid profile.   "
159677|NCT01193530|"     The goal of this research study is to learn if a type of light therapy can be used to help     patients with advanced cancer who are having difficulty sleeping to sleep better.   "
159678|NCT01193517|"     The goal of the Phase I portion of this study is to find the highest tolerable dose of     azacitidine combined with capecitabine and oxaliplatin (CAPOX) that can be given to patients     with metastatic colorectal cancer.      The goal of the Phase II portion of this study is to learn if azacitidine, given in     combination with CAPOX, can help to control metastatic colorectal cancer. The safety of this     drug combination will also be studied.   "
159679|NCT01193504|"     The purpose of this study is to determine if Lotemax eye drops are at least as effective as     Pred Forte eye drops, which are the standard of care after cataract surgery.   "
159680|NCT01193491|"     The purpose of this study is to evaluate the safety, determine the maximum tolerated dose     (MTD) and schedule of IPI-493 in patients with hematologic malignancies.   "
159681|NCT01193478|"     The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics     and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype     1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the     clinic for the initial 5 days of the study.   "
159682|NCT01193465|"     The effects of preserving humidity and temperature by low flow anesthesia are different in     each other anesthesia workstation.   "
159683|NCT01193452|"     This phase II trial on the assumption that S-1 combined with Leucovorin may have better     efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with     advanced colorectal cancer.   "
159706|NCT01193127|"     The purpose of this study is to determine whether the use of OMS302 (the study drug) in     individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and     effective at maintaining an adequately dilated pupil during surgery and reducing     post-operative symptoms of discomfort (such as eye pain and irritation).   "
159764|NCT01192373|"     The investigators wish to investigate the the short term effect of low circulating free fatty     acids in congestive heart failure patients with type 2 diabetes.      Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral     muscle lipid content, improves cardiac performance and exercise capacity.   "
159684|NCT01193439|"     Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes.     Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural     neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. The     indication of thoracoscopy in patients with pleural effusion has been optimized. In some     studies medical thoracoscopy has been claimed a useful diagnostic tool with a very low rate     of complications. However the investigators do not know its safety on high risk patients.     Because many patients having suspected malignancy have bed conditions due to other health     problems such as coronary heart diseases, COPD, arrythmia, hypoxemia. In this study the     investigators aimed to test the safety of medical thoracoscopy in the patients with high risk     for complications.   "
159685|NCT01193426|"     Spontaneous bacterial peritonitis (SBP), an infection of ascitic fluid in the absence of     localized intra-abdominal infection, is one of the main potentially fatal complications of     cirrhosis. In the case of SBP, early diagnosis and rapid therapeutic care can improve patient     survival (Garcia-Tsao, 2001).      The diagnosis of SBP is based on the detection of a polymorphonuclear neutrophils count equal     to or greater than 250 /mm3 in the ascitic fluid (method of reference). However, obtaining an     ascitic cell count is sometimes difficult because it can not always be performed in emergency     especially outside the opening hours of the laboratory of Bacteriology. This raises the     necessity of developing quick and easy alternative approaches of diagnosis.      Few groups have proposed the use of urinary reagent strip for rapid diagnosis of SBP.     Nevertheless, the investigators clinical teams have shown that the sensitivity of this test     was low in a large national multicenter prospective study involving more than a thousand     patients (Nousbaum et al., 2007). The use of Multistix strips test is thus not recommended     for the routine application of diagnosis of SBP due to its lack of sensitivity.      Although performed on small groups of patients, several studies have reported that IL-8 or     IL-6 might be used as markers of ascitic fluid infections. Based on these data and confirmed     by the investigators preliminary results the investigators propose to study on a broad     recruitment of patients estimated to about 500 inclusions (about 45 infected patients) the     interest of using IL-8 and IL-6 as predictive markers of SBP. The investigators propose to     use an ELISA method, standardized, rapid and automated, applicable in the context of     emergency (7 days a week and 24 hours a day) as previously described in the work conducted to     exclude the urinary tract infection (Oregioni et al., 2005).      During the preliminary experiments conducted for this project, the investigators also found     systematic variation of another marker, leptin. This is a protein hormone involved in the     inflammatory and immune responses (Otero et al., 2005). It appears necessary to include the     study of this marker in the analysis of differential protein response between patients     suffering or not suffering from SBP.      The investigators therefore propose a diagnostic study, non-interventional, prospective,     multicenter trial conducted over 2 years.        -  The main objective is to establish the diagnostic performance (sensitivity, specificity,          positive predictive value and negative) of IL-8 and IL-6, assayed in the ascites fluid          by an automated ELISA in the early diagnosis of SBP.        -  The secondary objectives are to confirm the interest of the measurement of leptin in the          SBP and to establish the diagnostic performance of IL-8 and IL-6 or leptin according to          different clinical features in patients (score Child-Pugh classification and history of          SBP, ascitic fluid infection with positive bacterial culture).   "
159686|NCT01193413|"     Early diagnosis of secondary infection of necrotic tissue in severe acute pancreatitis is     extremely important. The investigators evaluated whether the level of soluble TREM-1     (sTREM-1) in fine needle aspiration (FNA) fluid from patients who suspected infection is a     good marker of secondary infection of necrotic tissue and an indicator of the proper     treatment between drainage and necrosectomy.   "
160233|NCT01186224|"     To assess the efficacy and toxicity of plerixafor (AMD 3100) together with granulocyte-colony     stimulating factor (G-CSF) for stem cell mobilisation, in patients with myeloma or lymphoma     requiring high dose chemotherapy with stem cell rescue.   "
159687|NCT01193400|"     Primary outcome measure:      Evaluate the efficacy in terms of complete responses of induction therapy and first-line     consolidation of Clofarabine and low-dose Cytarabine with AML patients aged 60 years or more.     The first efficacy objective is evaluate the overall remission rate (TRG), where general     reference (RG) is defined as a patient who achieved complete remission (CR) or complete     remission with inadequate platelet recovery (CPR).      Secondary outcome measures:        -  To evaluate disease-free survival (DFS)        -  Evaluate the overall survival (OS)        -  To evaluate the safety and tolerability of clofarabine and duration, severity and          relationship of adverse events (AEs) occurring during treatment        -  To assess the rate of mortality at 30 days (ie, the incidence of deaths occurring          between Day 1 and Day 30 of induction cycle)        -  The incidence, intensity (according to the latest version of the CTCAE classification),          duration, causality, severity and type of AA   "
159688|NCT01193387|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate if two     identical formulations of NN1250 (insulin degludec, IDeg) have the same level of drug     exposure to the body.   "
159689|NCT01193374|"     A primary care approach to obesity prevention will be developed and tested in a randomized     trial in 4 pediatric primary care practices. Enhanced screening for obesity risks and prompts     for effective counseling at well visits of 4 to 10 year olds will be developed utilizing hand     held technology( PDAs). The impact on the content and quality of clinician counseling will be     assessed in exit survey prior to and after implementation. Among families interested in     making a change to address nutrition or activity risk reported on the screener a cohort with     children > BMI 85% will be recruited. They will be randomized to mailed tailored supports to     level of readiness to change versus a single generic informational mailing. The hypotheses     are that 1)families that receive the enhanced office visit with screening will be more likely     to plan to make changes compared to usual care; and 2) families receiving the tailored post     visit supports will be less likely to gain weight than controls after 6 months.   "
159690|NCT01193361|"     At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and     efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the     treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1     subjects   "
159691|NCT01193348|"     The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients     with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal     impairment.   "
159692|NCT01193335|"     The purpose of this study is to describe the safety, tolerability, and immunogenicity of a     2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to     preterm infants with concomitant vaccines, compared to infants born at term.There will be a     follow-up phase to assess the persistence of the antibody response at 24 and 36 months of     age.   "
159693|NCT01193296|"     The study will assess glycemic variability and optimized glycemic control in T2DM patients     treated with a DPP-4 inhibitor as add-on therapy to metformin.   "
159721|NCT01192932|"     Computed tomography (CT) studies considering bronchial dimensions in chronic obstructive     pulmonary disease (COPD) have never considered nycthemeral variations. Airway calibre, in     COPD patients, exhibits a nycthemeral variations with maximal values around noon and minimal     values in the early morning, that persists under long-acting bronchodilator. Furthermore, no     study has assessed the possible nycthemeral variations of CT scans parameters reflecting     airway remodelling and emphysema extent in COPD patients.      This is a prospective study whose purpose is to assess these variations and their     relationships with pulmonary function testing (PFT) in COPD patients.   "
159694|NCT01193283|"     Background:        -  Severe aplastic anemia (SAA) can lead to problems with bone marrow health and result in          low blood cell counts, which require frequent transfusions. Standard treatment for SAA          involves injections of antithymocyte globulin (ATG) plus cyclosporine (CsA). This          regimen has been shown to improve the blood counts in about two-thirds of patients.          However, the ATG/CsA regimen has the following limitations: (a) the disease can come          back (relapse) in about one-third of patients who improve initially; and (b) in about          10% to 15% of cases, certain types of bone marrow cancer (such as myelodysplasia and          leukemia) can develop (called evolution). Experience with other drugs in SAA such as          cyclophosphamide suggests that similar response rates to ATG/CsA can be achieved with a          lower risk of relapse and clonal evolution. However, cyclophosphamide was found to have          significant side effects in SAA when investigated over 10 years ago due to increase risk          of fungal infections.        -  Better antibiotic drugs against fungus have been developed and are widely used to treat          patients who have low white blood cell counts and are at risk of developing infections.          In SAA patients in particular, these newer antibiotics have had a large impact in          preventing and treating fungus infections. Researchers are revisiting the use of          cyclophosphamide in SAA treatment, and plan to give a lower dose of CsA in combination          with the immune-suppressing drug cyclophosphamide, as well as antibiotics to protect          against infections, as a possible treatment for the disease.      Objectives:      - To determine the safety and effectiveness of the combination of cyclophosphamide and     cyclosporine in treating severe aplastic anemia that has not been treated with     immunosuppressive therapy.   "
159695|NCT01193270|"     The purpose of this pilot trial is to test the safety and efficacy of administering one dose     of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks     gestation and less than 1000 grams birth weight). This pilot will examine whether a single     dose of vitamin E will be absorbed into the infants' bloodstreams with resulting serum     α-tocopherol level in the target range of 1-3 mg/dl.   "
159696|NCT01193257|"     This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus     prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant     prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy   "
159697|NCT01193244|"     This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700)     plus prednisone compared with placebo plus prednisone in the treatment of men with     progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)   "
159711|NCT01193062|"     The primary purpose of the study is to evaluate the effect of PF-04995274 on cerebrospinal     fluid levels of soluble Amyloid precursor protein fragments and Amyloid beta fragments     following single oral dose in healthy volunteers. Safety and tolerability of PF-04995274     single dose administration in healthy volunteers will also be assessed as part of the     objectives.   "
159712|NCT01193049|"     The purpose of this study is to evaluate the relationship between upper and lower airway     allergen-induced cytokine responses in mild asthmatics by attempting to demonstrate the     following: 1) a positive correlation between allergen-induced Type 2 T-helper cell (Th2)     cytokines (interleukins 5 and 13) in sputum and nasal exudates; and 2) a positive correlation     between effects of prednisone versus placebo on Th2 cytokines in sputum and nasal exudates.   "
159698|NCT01193231|"     STUDY OBJECTIVE: To evaluate the safety and efficacy of Acuvail 0.45% administered BID for     increasing corneal re-epithelialization, decreasing the time to zero pain in     post-photorefractive keratectomy (PRK) surgery, and PRK enhancement assessment at 6 months     post op      CLINICAL HYPOTHESES: Acuvail 0.45% administered twice daily is superior to Systane Ultra     lubricant in treating post PRK pain      OVERAL STUDY DESIGN:      Structure: Single-center, randomized, open label, contralateral (one eye receives Acuvail,     one eye Systane Ultra)      Treatment Group: Patients will be randomized to the eye that will receive Acuvail 0.45%     Assignment: Acuvail 0.45% in one eye, Systane Ultra in contralateral eye      Duration: 6.5 months      Controls: Systane Ultra preservative-free lubricant      Dosage/Dose Regimen: Study medication will be administered to the randomized eye through post     op days 1-2 BID      Visit Schedule: Screening (baseline), Day 2-30 (Surgery), post surgery Day 1 and each day     through corneal re-epithelialization, post surgery months 1, 3, and 6.      Number of Patients: 10 (20 eyes)      Condition/Disease: patients undergoing bilateral PRK surgery   "
159699|NCT01193218|"     This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in     Japanese patients with T2DM at first treatment period. The second treatment period is     required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese     patients with T2DM according to the ICH E1 guideline.   "
159700|NCT01193205|"     The aim of this study is to evaluate the effectiveness of a 20-week Dialectical Behaviour     Therapy (DBT) skills training group for the treatment of chronic suicidal and non-suicidal     self-injurious (NSSI) behaviours in individuals diagnosed with borderline personality     disorder (BPD). Previous research has established the effectiveness of a one year     comprehensive, combined individual and group DBT treatment. However, in practice, DBT is     often offered in a skills only group format. This study will consist of a randomized,     controlled trial designed to evaluate the effectiveness of DBT compared to a wait list     control. 84 participants will be randomized to the 20-week DBT group or the wait-list and the     following outcomes will be assessed:        1. frequency of suicidal and NSSI behaviours        2. symptom distress        3. impulsivity        4. treatment retention        5. skill acquisition and        6. social functioning      Assessments will occur at pre-treatment, 10 weeks, 20 weeks and 3 months post treatment. The     following main hypotheses will be examined: (1) Patients in the DBT skills group condition     will have superior outcomes to patients on the treatment as usual wait list control in areas     targeted by the treatment: frequency of suicidal and NSSI behaviours, emergency room visits,     psychiatric hospital admissions, impulsivity, and knowledge and use of behavioral skills,     general symptoms. The group receiving DBT will have superior outcomes at post treatment and     these outcomes will be maintained during the three month post-treatment follow-up.   "
159701|NCT01193192|"     This study is a multi-site, retrospective chart review to determine the effect of Neevo® or     NeevoDHA® (with higher folate and B12) versus standard prenatal vitamins on hemoglobin (Hgb)     levels in pregnant women throughout the course of pregnancy. Neevo® is a prescription medical     food indicated for the dietary management of women under a doctor's care who face high risk     pregnancies, older overactive bladder (OB) patients and patients unable to fully metabolize     folic acid. Data will be collected from existing patient charts of subjects administered     Neevo® or NeevoDHA® daily compared to subjects administered a prenatal vitamin daily.   "
159702|NCT01193179|"     The purpose of this study is to investigate the safety of OPC-262 administered orally in     combination with another oral antihyperglycemic agent   "
159703|NCT01193166|"     The study will assess the use of paliperidone palmitate compared with oral antipsychotic     treatment in delaying time to a protocol-defined treatment failure over 12 months, in     patients diagnosed with schizophrenia who were recently released from an inpatient     psychiatric hospital.   "
159704|NCT01193153|"     This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the     delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the     safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.   "
159705|NCT01193140|"     To evaluate the safety and tolerability of the veliparib/TMZ combination in subjects with     solid tumors.   "
159722|NCT01192919|"     Overview of treatment reality in patients with bronchial carcinoma requiring systemic     treatment and being treated by office-based oncologists in Germany.   "
159707|NCT01193114|"     Aim 1. Identify specific targets and processes of intervention among homeless substance     abusing mothers with children between the ages of 2 and 6 years from information collected in     focus groups and assessment interviews. Translate that information for the refinement of the     ecologically based treatment manual.      Aim 2. Test the efficacy of the treatment in a nonrandomized pilot study and revise the     manual based upon those findings.      Aim 3. Test the efficacy of the experimental intervention compared to treatment as usual     (TAU) in a randomized pilot, with the goal to improve maternal substance abuse problems,     social stability, and mental health. It is expected that the experimental intervention will     be associated with lower substance use and related problem behaviors than TAU.      Aim 4. Test whether intended change processes (mediators) associated with the intervention     produce the desired change in mother's substance use, social stability, and mental health. It     is expected that self-efficacy will mediate substance use outcomes.      Aim 5. Explore how length of homelessness, age and ethnicity of the mother predict treatment     response (moderators).      Aim 6. Explore the impact of the experimental intervention (Ecologically-Based Therapy)on     interpersonal stress and child's mental health.   "
159708|NCT01193101|"     This study is a phase 2 study in patients with essential hypertension.   "
159709|NCT01193088|"     This project includes two projects. One is looking for new genes that cause Charcot Marie     Tooth disease (CMT). The other is looking for genes that do not cause CMT, but may modify the     symptoms a person has.   "
159710|NCT01193075|"     This is an observational longitudinal study to determine the natural history and     genotype-phenotype correlations of disease causing mutations in Charcot Marie Tooth disease     (CMT) type 1B (CMT1B), 2A (CMT2A), 4A (CMT4A), and 4C (CMT4C).      The investigators will also be determine the capability of the newly developed CMT Pediatric     Scale (CMT Peds scale) and the Minimal Dataset to measure impairment and perform longitudinal     measurements in patients with multiple forms of CMT over a five year window   "
159713|NCT01193036|"     Objectives:      The objective of this study is to develop a valid and reliable measure of the symptom burden     experienced by patients with cancer experiencing disease-related skin problems and to     delineate this burden over time.      The Primary Aim is to develop and validate an M.D. Anderson Symptom Inventory (MDASI) module     (the MDASI-Derm), compliant with FDA standards for patient-reported outcomes (PROs), to     measure the severity of multiple symptoms and the impact of these symptoms on daily     functioning in patients with cancer-related skin problems. We hypothesize that the MDASI-Derm     will be valid and reliable for measuring the severity of multiple symptoms and the impact of     these symptoms on daily functioning in patients with cancer-related skin problems.      The Secondary Aims are:        1. to develop a detailed description of the severity and interference with daily activities          of symptoms experienced by patients with cancer-related skin problems;        2. to assess the impact of symptom severity on standard function and quality of life (QOL)          measures including both quantitative (Eastern Cooperative Oncology Group [ECOG]          Performance Status, single-item QOL, and Skindex-16 scales) and qualitative measures          (patient interviews);        3. to evaluate the MDASI-Derm as an estimate of functional status and QOL in patients with          cancer-related skin problems;        4. to identify common clusters of symptoms and symptom patterns occurring over multiple          measurement time points in patients with cancer-related skin problems;        5. to define the qualitative symptom experience of patients with cancer-related skin          problems;        6. to explore the feasibility of the Interactive Voice Response (IVR) system in measuring          symptom severity and interference with daily activities over time in patients with          cancer-related skin problems.   "
159714|NCT01193023|"     The purpose of this study is to document the prevalence and type of asynchronies incidence     during invasive mechanical ventilation in pediatric patients breathing under pressure     support.      And to observe the impact of adjusting the expiratory trigger setting on asynchronies, and     compare these incidences with asynchronies measured in pediatric patient breathing under NAVA     system (Neurally Adjusted Ventilatory Assist).   "
159715|NCT01193010|"     This study is designed as a multi-center randomized controlled trial, comparing two groups of     patients with symptomatic extra-articular malunited distal radius fractures. One group of     patients will undergo corrective surgery of the distal radius, with preoperative     computer-assisted planning and virtual osteotomy, and the other group will undergo corrective     surgery, with conventional (non-computer-assisted) preoperative planning. The investigators     hypothesize that computer-assisted surgical planning will result in a better functional     outcome.   "
159716|NCT01192997|"     There is evidence of waning immunity in individuals vaccinated against meningitis C as part     of the UK infant immunisation schedule. The intention of this study is to contact     participants of a previous NVEC (National Vaccine Evalutaion Consortium) clinical trial (a     PreSchool Men C trial, in which participants were randomised to receive Meningitec, Menjugate     or Neisvac-C). They will be invited to enrol and will be randomised to receive one of two     quadrivalent meningococcal ACWY vaccines, to look at the boosting effect they may confer.   "
159717|NCT01192984|"     The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered     eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell     lymphoma. The primary objective is to assess the antitumor effect in terms of best overall     response, while the secondary objectives are to assess the antitumor effect in terms of best     response by disease lesion, to assess the progression-free survival and to assess the overall     survival. The safety and pharmacokinetic profiles of KW-0761 will be also evaluated.   "
159718|NCT01192971|"     This phase II trial will be studying how well Apatinib working in patients with liver cancer.   "
159719|NCT01192958|"     At present influenza immunity can only be reliably confirmed by a blood test. This test is     invasive for the patient. This study is intended to validate an oral fluid/saliva antibody     test for the variant Swine Influenza H1N1. If such a test were available, this painless and     non invasive test will improve direct clinical care to an individual as well as significantly     help guide future public health management of the pandemic.   "
159720|NCT01192945|"     The purpose of this non-interventional study is to collect data on the efficiency and safety     of Azacitidin in the routine application.   "
160216|NCT01186445|"     The purpose of this study is to determine whether intracoronary injection of morphine     chlorhydrate is effective to limit ischemia-reperfusion lesion during percutaneous coronary     angioplasty in patients with acute myocardial infarction (AMI).   "
159723|NCT01192906|"     This multi-center, randomized, double blind, parallel-group, placebo-controlled study will     evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent,     predominant negative symptoms of schizophrenia. Patients, on stable treatment with     antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching     placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.   "
159724|NCT01192893|"     Oxytocin is a neurohypophysial hormone involved in several central and peripheral functions     including parturition, milk let-down reflex and social behaviour. In vitro and animals     studies have shown growing evidence that oxytocin plays a role in bone remodeling and     osteoporosis. The investigators have previously show in a small sample of post-menopausal     women with severe osteoporosis (n=20) compare to healthy control (n=16) that oxytocin serum     level is significantly decreased, independently of leptin and estradiol, that are known to     modulate oxytocin secretion. Thus, oxytocin appears as a new interesting factor in the     osteoporosis pathophysiology. The aim of the present study is to confirm the relationships     between bone status, evaluated by bone mineral density and prevalent fragility fractures,     body composition and oxytocin serum levels on a large population. The investigators will also     determine if the relationship between bone mineral density and oxytocin is independent of     estradiol and leptin in this population and evaluate the relationships between oxytocin serum     level and co-morbidities such as cardiovascular diseases, depression and dementia. Theses     analysis will be done on the serum already available of 1000 women of the international OPUS     cohort. Bone mineral density, body composition analysis by Dual energy X-ray Absorptiometry     (DXA), estradiol and clinical data are already available. The investigators will select     women, aged from 55 to 79 y at the time of inclusion.   "
159725|NCT01192880|"     This Phase 3, multi-center, randomized, double blind, parallel-group, placebo-controlled     study will evaluate the efficacy and safety of RO4917838 (bitopertin) in participants with     persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment     with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching     placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.   "
159738|NCT01192711|"     The Diabetes Interactive Diary (DID) is both a CHO (carbohydrates )/insulin bolus calculator,     an information technology and a telemedicine system based on the communication between health     care professional and patient by SMS messages.      Aim of the study is to compare an insulin regimen of insulin glargine + prandial insulin     glulisine associated with a telemedicine system to teach CHO counting (DID) with the same     insulin regimen administered according to usual practice.   "
159726|NCT01192867|"     This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will     evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant     negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics,     will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks     (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional     treatment extension for up to 3 years. After 52 weeks, participants who were originally     randomized to an active treatment will be randomly assigned to receive either placebo or     continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to     Week 56) for the assessment of potential withdrawal effects in a blinded manner using     participants staying on active treatment as a control. Participants initially randomized to     placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in     the washout period will return to their blinded, active treatment arm.   "
159727|NCT01192854|"     Randomized, double blind parallel group, positive control, multi-center trial. Patients will     be randomized at 1:1 ratio in group A or group B   "
159728|NCT01192841|"     Governmental agencies in the United Kingdom and Scotland have recently instituted guidelines     banning physicians' white coats and wearing of long-sleeved garments to decrease hospital     transmission of bacteria. The purpose of this study is to compare the bacterial contamination     of physicians' white coats with that of newly laundered, standardized short-sleeved uniforms     after an eight-hour workday and to determine the rate at which bacterial contamination of the     uniform ensues. Our hypothesis was that the physician white coat would have more bacterial     contamination at the end of the work day.   "
159729|NCT01192828|"     Cystathionine beta-synthase deficiency is an inherited disease that results in elevation of a     substance called homocysteine (Hcy) in blood and urine. Individuals with this disorder have a     very high risk for developing blood clots and are at risk for developing eye and bone     abnormalities. Current treatments are generally difficult to follow and can fail. Development     of additional therapies has been limited by lack of understanding of how the disease works.      The purpose of this study is to see if oxidative stress and inflammation are involved in the     disease process and if short-term supplementation with taurine is an effective treatment.      Funding source: FDA-OOPD   "
159730|NCT01192815|"     RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Erlotinib hydrochloride may also make tumor cells more     sensitive to radiation therapy. Radiation therapy uses high-energy x- rays and other types of     radiation to kill tumor cells. Giving erlotinib hydrochloride together with radiation therapy     may be an effective treatment for patients with head and neck cancer.PURPOSE: This phase II     trial is studying how well giving erlotinib hydrochloride together with radiation therapy     works in treating patients with stage III-IV squamous cell cancer of the head and neck.   "
159731|NCT01192802|"     Albendazole is a main anti-helminth, however there is a lack of data regarding its efficacy     in the school children population. The aim of this study is to evaluate the efficacy of the     albendazole one versus two and three doses, in school children infected with intestinal     helminth.   "
159732|NCT01192789|"     Two-arm cluster randomized controlled trial located in Hala district, Pakistan to determine     the impact of using Lady Health Workers (LHW) of National Program for Family Planning and     Primary Health Care to diagnose and manage severe pneumonia with oral amoxicillin on     treatment failure rates at day 6 among 2-59 month old children. LHWs in the control arm     receive a refresher in standard pneumonia case management. LHWs in the intervention arm     receive standard training that is enhanced to include training in the recognition of severe     pneumonia and its home management with oral amoxicillin. Clusters are by Union Council (UC),     administrator units consisting of 7 to 25 LHWs; each UC is randomized to either enhanced     pneumonia case management with oral amoxicillin therapy (intervention) for severe pneumonia     or standard case management and referral to the nearest health facility for treatment     (control). Process indicators reflecting the LHW's ability to assess, classify and treat     pneumonia in the intervention group and cost-effectiveness data is also being collected.      Primary Hypothesis:      Enhanced pneumonia case management and oral amoxicillin therapy for severe pneumonia     delivered by LHWs in the community will result in a reduction in treatment failure among     children 2 - 59 months of age with severe pneumonia who are treated by the LHW compared with     those referred for care by the LHW.      Secondary Hypotheses:        1. The proportion of treatment failure, [persistence of lower chest indrawing (LCI) or need          for second line treatment between day 3 and day 14], will be less in the intervention          arm compared with the control arm.        2. LHWs can adequately assess, classify, and treat severe pneumonia in 2 - 59 month old          children, and adequately recognize and refer children who present with danger signs          during initial antimicrobial therapy.   "
160217|NCT01186432|"     This study will evaluate the preliminary safety and efficacy of PDS 1.0 in patients with     neovascular AMD.   "
159733|NCT01192776|"     The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born     at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72     hours to 33.5°C; (2) cooling for 120 hours to 33.5°C; (3) cooling for 72 hours to 32.0°C; and     (4) cooling for 120 hours to 32.0°C. The objective of this study is to evaluate whether     whole-body cooling initiated at less than 6 hours of age and continued for 120 hours and/or a     depth at 32.0°C in will reduce death and disability at 18-22 months corrected age.   "
159734|NCT01192763|"     This phase I trial is studying the side effects of RO4929097 before surgery in treating     patients with pancreatic cancer. RO4929097 may stop the growth of tumor cells by blocking     some enzymes needed for cell growth. Giving RO4929097 before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed.   "
159735|NCT01192750|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in tissue samples from patients with     recurrent and/or metastatic squamous cell cancer of the head and neck previously treated with     cisplatin with or without cetuximab.   "
159736|NCT01192737|"     The purpose of this study is to measure the incidence of A/H1N1 Influenza infection in the     mother and her child and to identify the determinants in pregnant women during pandemic     period in three public maternities in Paris, France.   "
159737|NCT01192724|"     Because there is limited data about long-term efficacy and safety about short-term use of     cilostazol adding to dual antiplatelet therapy in patients with long or multivessel coronary     artery disease after 2nd generation DES implantation, especially in biodegradable polymer     stent, the investigators will evaluate whether a 3-month use of cilostazol in addition to     dual antiplatelet therapy effectively reduces clinical adverse outcome at 1 year in subject     with long or multivessel coronary artery disease after biolimus-eluting stent implantation.   "
160274|NCT01185691|"     The primary objective of this study is to assess safety and feasibility of IMPELLA 2.5 in     Acute Decompensated Heart Failure patients.   "
159739|NCT01192698|"     The main goal of this study is to prevent liver allograft infection with Hepatitis C virus in     hepatitis C positive patients undergoing liver transplantation. The hypothesis is that     patients who receive ribavirin immediately before transplant and intravenous interferon alfa     2b during the anhepatic phase(while the liver is removed)will have sustained virologic     response post liver transplant.   "
159740|NCT01192685|"     This a 12- week study (1-4 week screening, 6 weeks treatment, 2 weeks follow-up) outpatient     open label clinical trial. Twenty-five subjects diagnosed with depression with a Montgomery     Asberg Depression Rating Scale (MADRAS) score of 26 or higher, will be enrolled into this     trial, up to fifty subjects will be consented. The primary purpose of the current study is to     determine: 1) if changes in electrical activity of the brain measured by EEG in specific     areas is associated with changes in the blood flow of the brain 2) Which areas of the brain     show changes in electrical activity and treatment response.   "
159741|NCT01192672|"     The purpose of this study is to test whether disease-related expressive writing is effective     in the treatment of Irritable Bowel Syndrome (IBS).   "
159742|NCT01192659|"     The purpose of this study is to identify risk factors for low lymphocyte count among patients     with type 2 diabetes who are treated with oral antidiabetic drugs.   "
159743|NCT01192646|"     Background      The maternal mortality ratio in Tanzania has been persistently high for ten years with no     signs of the ratio going down.The Tanzania Demographic and Health Survey (TDHS) of 1999 and     2005 estimate the maternal mortality ratio to be 528 and 578 per 100,000 live births     respectively (TDHS 1999, TDHS 2004/05).The major direct causes include obstetric haemorrhage,     obstructed labour, pregnancy induced hypertension, sepsis and abortion complications.      Most deliveries (53%) in Tanzania occur outside the health facilities. Of these 53% of births     that occur outside the health facilities 31% are attended by relatives, 19% by traditional     births attendants (TBA) while 3% have no assistance at all. Though, the proportional of     mothers delivering in health facilities (47%) and receiving skilled attendance at birth (46%)     is low but more than 94 percent of women attend antenatal care (ANC) in health facilities at     least once. This indicates that there are factors that impede these women delivering in the     health facilities.      Low awareness of obstetric danger signs may be one of the contributing factors for delay to     decide to seek care when a complication occur thus contributing the first phase of delay.     Studies in Tanzania show that most women are not aware of danger signs of obstetric     complications during pregnancy, delivery and after delivery. A study conducted in Mtwara     rural to assess the use and determinants of skilled attendants at delivery showed that     proportional of women delivered with skilled care increases with increasing knowledge of     pregnancy danger signs, but it also showed that few women have knowledge of pregnancy danger     signs      An increasing body of evidence supports the importance of community participation in maternal     and infant health programs for establishing ownership, identifying problems effectively,     achieving equity and helping to institutionalize health programs. To mount an effective     maternal health effort aimed at reducing maternal and infant mortality, multiple levels of     program and policies need to be in place and functioning. In addition, linkages, from the     communities, local dispensaries and health centres to first referral hospitals that are     adequately equipped, need to be developed and sustained      A home based life saving skills (HBLSS) is a strategy that intends to educate pregnant women     and their primary family caregivers and home birth attendants on critical knowledge and     skills to keep a pregnant woman healthy, to recognize life-threatening maternal and newborn     complications and promote the adoption of health care and health-seeking behaviours at the     individual and community levels. The aim of this strategy is to prevent maternal and neonatal     morbidity and mortality through creating awareness on women's birth preparedness and access     to emergency obstetric care services      RESEARCH QUESTIONS        1. Can HBLSS increase women empowerment and male involvement in the decisions relating to          access of emergency obstetric and newborn cares?        2. Can the HBLSS increase hospital deliveries, increase awareness of obstetric and neonatal          danger signs, birth preparedness and emergency readiness in a rural community?      Objectives      Broad Objectives:        1. To investigate social-cultural, community and traditional practices that impact on          women's birth preparedness and access and utilization of emergency obstetric care          services in rural district.        2. To assess the impact of home based life saving skills (HBLSS) on hospital delivery          awareness of obstetric and neonatal danger signs, birth preparedness      Specific Objectives        1. To explore customs, taboos and practices including herbal remedies during pregnancy and          labour that influence birth preparedness and utilization of emergency obstetric care          services.        2. To assess perception, attitude and health seeking behaviour when a complication occur.        3. To determine the effect of HBLSS educational programme on hospital delivery, birth          preparedness, emergency readiness and utilization of emergency obstetric care services          among women in Rufiji district.        4. To assess the impact of HBLSS educational programme on male awareness and involvement in          assisting women on birth preparedness and access to emergency obstetric care services.        5. To determine the cost-effectiveness of HBLSS educational programme      Methodology      A Cluster Randomized Trial      28 clusters will be randomly selected, 14 clusters will receive HBLSS training and the other     14 clusters will not receive HBLSS training.   "
159744|NCT01192633|"     The primary objective of this study is to evaluate PFS of gemcitabine,vincristine and     cisplatin as second line therapy in patients with sarcoma. 40 patients will be treated into     this study.   "
159745|NCT01192620|"     The purpose of this study is to test a standardized approach for children being evaluated for     appendicitis in the emergency department. This means that all doctors would use the same     approach to diagnose appendicitis in children in the emergency department. This pathway uses     two scoring systems to identify patients who are at high and low risks of appendicitis. These     scoring systems are based on the patient's symptoms, signs the doctor finds when examining     the patient, and their blood tests. The goal of this part of the study is to determine if the     investigators' pathway accurately identifies patients who have appendicitis.   "
159746|NCT01192607|"     The objectives of this Phase I study is to evaluate the safety and effectiveness of the     endoscopic endodontic equipment device for root canal assistance treatment as well as to     evaluate the ease of use of this device, by a surgeon experienced in endodontic treatment, in     a true clinical setting.   "
159747|NCT01192594|"     This nested design clinical outcome study of psychiatric case manager education on disease     state, psychopharmacology of schizophrenia, relapse, motivational interviewing, and the     process of psychological adjustment post-psychosis (Milestones of Adjustment Post-Psychosis     Recovery Model-MAPP) will test the following hypotheses:        1. Medication non-adherence in patients with schizophrenia assigned to case managers who          receive MAPP training will decrease from their pre-study rate and from the reported          national average after one year enrollment compared to consumers not enrolled in the          MAPP arm of the study.        2. Consumers in the MAPP intervention will have higher Quality of Life Enjoyment and          Satisfaction Questionnaire (Q-Les-Q (53) scores than consumers not enrolled in the MAPP          at quarterly measures.        3. Consumers enrolled in the MAPP intervention arm of the study will successfully complete          the first two phases of the MAPP Recovery Model in one year.        4. Consumers in the MAPP intervention arm will have greater symptom reductions at quarterly          data points compared to consumers not enrolled in the MAPP intervention arm.   "
159748|NCT01192581|"     The aim of this study is to evaluate the effectiveness, safety and tolerability of consistent     dosages of the study drug (hydroxyethyl starch 130/0.4 and sodium chloride injection,     Vuloven) administrated intravenously for 7 days.   "
159763|NCT01192386|"     Inflammatory proteins from eosinophil granulocytes in blood from patients with seasonal     allergic hayfever have been shown to predict development of asthma at a six-year follow-up.     This study is a 15-year follow-up of the same patients to verify earlier results and study     disease development.   "
159749|NCT01192568|"     This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in     children 3 to less than 17 years old, who have overactive bladder due to a neurogenic     condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then     return to the clinic for a potential dose titration. At this time their dose may be adjusted     up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the     individual response and tolerability. The total treatment time is 14 weeks and total time on     the study is 16 weeks.   "
159750|NCT01192555|"     Neuroblastoma is the second most common solid tumor seen in children, but causes     approximately 15% of childhood cancer deaths each year. Patients with high-risk disease     require treatment with a combination of chemotherapy, surgery, radiation, and stem cell     transplant; however, many will have their disease come back within 3 years. Due to this high     rate of relapse, this study is being done to investigate an experimental treatment option for     children whose disease has returned.      This clinical trial is for patients with neuroblastoma that has either come back after     treatment or never went away in the first place. A series of immunizations will be     administered using a tumor vaccine and add low-dose chemotherapy to be taken by mouth on a     daily basis. The hope is that the vaccine will cause the immune system to recognize and kill     more types of neuroblastoma tumors. Additionally, the immunizations will be combined with     daily low dose chemotherapy. Daily low-dose chemotherapy, also know as metronomic     chemotherapy, works by attacking the blood vessels that allow tumors to grow. Using     metronomic doses of a drug called cytoxan can also decrease T regulatory cells, a specific     type of cell that tumors use to hide from the immune system.      The purpose of this study is to test the safety and anti-tumor effect of the tumor cell     vaccination plus low dose, metronomic chemotherapy in treating patients with     relapsed/refractory neuroblastoma.   "
159751|NCT01192542|"     The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the     new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven     (7) days.   "
159752|NCT01192529|"     The most common symptoms associated to senile dementia disease are confusion about schedules,     hyperactivity... In this sense, these patients have frequently poor nutrition, resulting in     malnutrition problems or malnutrition high risk.   "
174152|NCT00113737|"     To test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improves     the depression-prone smoker's ability to quit.   "
159755|NCT01192490|"     The hypothesis of this study is that topical cervical and intra-cervical lidocaine will     decrease pain associated with the insertion of a Mirena® (levonorgestrel intrauterine     device).      1. Primary Aim- Determine if topical lidocaine intra-cervically and on the cervix decreases     the pain associated with insertion of a Mirena® (levonorgestrel intrauterine device).   "
159756|NCT01192477|"     Increases in air pollution are associated with increases in deaths from cardiovascular     disease, but the investigators know little about how ozone air pollution affects the     cardiovascular system. The investigators proposed study will determine the effects of ozone     on blood vessel and heart function that could worsen illness in people with underlying heart     disease. This will be accomplished by studying healthy volunteers who inhale ozone in a     controlled clinical study, and also by studying their exposure to ozone and other pollutants     during their normal daily activities. The investigators will study volunteers who may be at     increased risk for the effects of ozone because of genetic susceptibility. Understanding the     effects of ozone on the heart and circulation can help establish appropriate air pollution     standards, and provide strategies to protect the most susceptible people.   "
159757|NCT01192464|"     Patients have a type of lymph gland cancer called non-Hodgkin Lymphoma or Hodgkin's Lymphoma.      The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancer. This research study combines two different ways of fighting disease:     antibodies and T cells. Antibodies are proteins the protect the body from diseases caused by     germs or toxic substances. They work by binding those germs or substances, which stops them     from growing and causing bad effects. T cells, also called T lymphocytes, are special     infection-fighting blood cells that can kill other cells, including tumor cells or cells that     are infected with germs. Both antibodies and T cells have been used to treat patients with     cancers: they both have been shown promise, but have not been strong enough to cure most     patients. We hope that both will work better together.      We have found from previous research that we can put a new gene into T cells that will make     them recognize cancer cells and kill them. We now want to see if we can attach a new gene to     T cells that will help them do a better job at recognizing and killing lymphoma cells.      The new gene we will put in T cells makes and antibody called anti-CD30. This antibody sticks     to lymphoma cells because of a substance on the outside of the cells called CD30. Anti-CD30     antibodies have been used to treat people with lymphoma, but have not been strong enough to     cure most patients.      For this study, the anti-CD30 antibody has been changed so that instead of floating free in     the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way     it is called a chimeric receptor. These chimeric receptor-T cells seem to kill some of the     tumor, but they don't last very long and so their chances of fighting the cancer are unknown.      We have found that T cells that are also trained to recognize the virus that causes     infectious mononucleosis can stay in the blood stream for many years. These are called EBV     specific Cytotoxic T Lymphocytes. By joining the anti-CD30 antibody to the EBV CTLs, we     believe that we will also be able to make a cell that can last a long time in the body and     recognize and kill lymphoma cells. We call the final cells CD30 chimeric receptor EBV CTLs.     There is also some evidence that patients whose tumors are EBV negative also benefit from     this study treatment if their tumor expresses CD30. If we are successful, we hope that these     new cells may be able to work longer and target and kill lymphoma cells. However, we do not     know that yet.   "
159758|NCT01192451|"     The Respiratory Insufficiency Outcome (RIO) project consists in a french multicenter     prospective cohort of patients with chronic obstructive pulmonary disease (COPD) undergoing     domiciliary noninvasive positive pressure ventilation.   "
159759|NCT01192438|"     The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal     therapy of biopsy confirmed low-risk prostate cancer.   "
159760|NCT01192425|"     Examine red and white blood cells of PNH patients with bone marrow failure syndromes.   "
159761|NCT01192412|"     The investigators do not know which approach to treatment of non-severe high blood pressure     in pregnancy is better for women and babies.      In the CHIPS Trial, the investigators seek to determine whether 'less tight' control (aiming     for a diastolic blood pressure [dBP] of 100 mmHg), compared with 'tight' control (aiming for     a diastolic blood pressure [dBP] of 85 mmHg) can decrease the risks of adverse baby outcomes     without increasing the risk of problems for the mother.   "
159762|NCT01192399|"     The objective of this study was to assess the safety and efficacy of eculizumab in hemolytic     PNH patients. In addition, the pharmacokinetics (PK) and pharmacodynamic (PD) response of     eculizumab was assessed and compared to overseas studies of eculizumab treatment in hemolytic     PNH patients.   "
159765|NCT01192360|"     The primary objective of this study is to determine if quantitative Dynamic contrast-enhanced     magnetic resonance (DCE MR) perfusion imaging accurately quantifies right and left pulmonary     artery blood flow as compared with phase contrast flow velocity mapping (PC), the current     gold standard of flow volume measurements.   "
159766|NCT01192347|"     This is an observational study to explore how different treatment regimens affect     continuation with treatment in the first 6 months following initiation of XAGRID into adult     patients' essential thrombocythemia therapy.   "
159767|NCT01192334|"     It was well known that total knee arthroplasty could improve the previously impaired     proprioception in degenerative osteoarthritis. Most current researches have been focused on     the change of the proprioception. However, the evaluation of the proprioception is based on     the surrogated end.      Double or single limb standing balance is considered functional scale. It is very important     view for the prevention of slipping down injury in evidence-based approaches for knee     osteoarthritis.      Unfortunately, few study have been performed for figuring proprioceptive change after surgery     out.      Considering the similarity between the proprioception and the standing balance and reported     positive result in proprioception after total knee arthroplasty, the investigators supposed     that total knee arthroplasty might give an influence on the recovery of single limb standing     balance.   "
159768|NCT01192321|"     The objectives of this study are to assess and compare bilateral uncorrected distance visual     acuity and distance spectacle independence post bilateral implantation of AcrySof Toric     Intraocular Lenses (IOLs) and monofocal IOLs. Secondary outcomes will include cost of     eyeglass purchased and patient vision-related quality of life.   "
159769|NCT01192308|"     All women on tamoxifen receive the standard dose of 20mg QD, irrespective of the use of     potential CYP2D6 inhibitors, and are not tested for CYP2D6 polymorphisms prior to start of     tamoxifen treatment.However CYP2D6 polymorphisms and/or the use of CYP2D6 inhibitors as     co-medication may influence the treatment outcome of tamoxifen.      The investigators propose a prospective study in women taking tamoxifen at a dose of 20mg QD.     In each woman, information will be collected on endoxifen levels, CYP2D6 status, adherence     and use of co-medication. In women who are phenotypically poor metabolizers of tamoxifen, a     dose increase to 40mg QD will be applied and the effect of this intervention on tamoxifen     pharmacokinetics will be evaluated after 4 weeks.   "
159770|NCT01192295|"     The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl)     controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years,     inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid     therapy.   "
159771|NCT01192282|"     This is a longitudinal observational study of women presenting to Groote Schuur Hospital with     genital warts. The study will evaluate the socio-demographic characteristics of the women     using a structured questionnaire. It will also document the site and extend of the genital     warts and genotyping will be performed on the warts. HIV status will be determined with     patient consent, treatment modalities will be documented as will the outcome of treatment     over a 6 month's period. Risk factors for recurrence or failure of treatment will be analysed     as will the costs of treating women with genital warts.   "
159772|NCT01192269|"     Various biological materials have been investigated to determine dietary fatty acid intakes,     such as plasma, erythrocytes, and adipose tissue. The applied techniques are invasive     sampling methods and may have limitations in studies involving infants or young children. In     1985 the group of McMurchie suggested buccal cheek cells as a marker for dietary fatty acid     intake; however fatty acid profiling in cheek cells has not been widely used yet.      In a clinical intervention trial a new method will be tested. The study will consist of two     consecutive parts: A) a correlation study will investigate the relationship between     established fatty acid markers (red blood cells (RBC), plasma) and the newly proposed markers     (cheek cells) before and after intervention B) an intervention study will investigate the     time depended implementation and steady state of docosahexaenoic acid DHA in plasma, RBC and     cheek cells.      The participants will receive 520 mg DHA daily over a period of 30 days. Blood and cheek cell     samples will be collected once prior to study commencement and regularly during intervention.      The proposed study aims at verifying cheek cell analysis results as a non-invasive marker for     fatty acid profiling. This will be shown by correlation analyses of fatty acids in cheek     cells, erythrocytes and plasma phospholipids. Furthermore, the time kinetics of DHA     incorporation into cheek cells will clarify if cheek cell fatty acids can be considered as a     short or long term marker.      The new non-invasive method is expected to be extremely valuable as a non-invasive approach     for studying the fatty acid profile in human, including infants and young children.     Therefore, it is of great interest to validate the new method in a clinical trial.   "
159773|NCT01192256|"     A large project consisting of:      a) an observational trial where smoking status is recorded on 1400 consecutive people newly     diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon     monoxide (eCO) levels every 3 months. Survival, cancer progression and treatment     complications will be recorded and compared in smokers, ex-smokers and never smokers.   "
159774|NCT01192243|"     The purpose of this study is to examine the efficacy and safety of gefitinib combinated with     Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).   "
159775|NCT01192230|"     The purpose of this study is to examine the efficacy and safety of endostatin combined with     Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or     second-line chemotherapy.   "
159776|NCT01192217|"     The investigators conducted a prospective randomized study to compare axillary     minithoracotomy versus a modified two-port thoracoscopic technique for surgical pleurodesis     in patients with recurrent spontaneous pneumothorax operated in a single institution.      The main objective of the study was to investigate possible differences regarding short- and     long-term clinical outcome between the two different techniques.   "
159820|NCT01191645|"     The purpose of this study is to determine whether a dopamine receptor antagonist     metoclopramide can counteract opioid induced effects on esophageal motility and lower     esophageal sphincter. The aim of this study is also to evaluate if the opioid antagonist     naloxone reduces the opioid induced pharyngeal and esophageal dysfunction.   "
160894|NCT00000334|"     The purpose of this study is to compare agonist and antagonist profile associated with     buprenorphine vs. methadone during opiate withdrawal.   "
159777|NCT01192204|"     This is a multicenter placebo-controlled clinical trial to assess the effects of a topically     applied gel on precancerous oral epithelial lesions. A total of 41 participants will be     enrolled in this trial, and 22 of them will be enrolled at Ohio State. [The remaining 19     participants will be enrolled at the University of North Carolina (9 participants) and the     University of Louisville (8 participants)]. At all three institutions, half of the     participants will randomly be assigned to the 10% FBR gel (0.5 gm four times daily for 3     months), while half will enter the placebo control arm. All trial participants will have a     pretreatment (including lesional and perilesional tissue) biopsy taken before and an     excisional biopsy after 3 months of treatment. As pretreatment indices are compared to post     treatment effects on each patient, patients serve as their own internal control. Pretreatment     lesional biopsies are obtained to establish a pretreatment diagnosis and provide a     pretreatment baseline for the experimental parameters.   "
159778|NCT01192191|"     The primary purpose of the study is to evaluate the safety and tolerability of fluticasone     furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese     patients with COPD.   "
159779|NCT01192178|"     Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel     group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma     exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316     subjects. Eligible subjects will be randomly assigned to one of two double-blind treatments     using a 1:1 randomization. Subjects will be identified for their eligibility for enrolment     starting in April 2010. Eligible subjects will be invited to return for randomization into     the study in August 2010. This exploratory study is being conducted to assess whether     treatment with ADVAIR™ DISKUS™ 100/50 mcg is more effective at reducing the risk of     exacerbation and the asthma impairment associated with viral respiratory tract infections     during the fall season when compared to treatment with FLOVENT™ DISKUS™ 100 mcg.   "
159780|NCT01192165|"     The purpose of this study is to determine what dose of GSK1120212 can be given safely in     combination with at least one other drug that is already approved to treat cancer. This study     will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212     plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed +     cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future     trials to test whether the combination treatment is a safe and effective therapy for subjects     with metastatic lung and/or pancreatic cancers.   "
160784|NCT00000221|"     The purpose of this study is to determine if two times a subject's daily maintenance dose     will hold for 48 hours without changes in agonist and antagonist effects.   "
159781|NCT01192152|"     The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg     metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt     Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured     in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in     Evansville, Indiana) in the fed state in healthy subjects.   "
159782|NCT01192139|"     The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg     metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt     Vernon, Indiana [IN]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet     (manufactured in Evansville, IN) in fed healthy subjects.   "
159783|NCT01192126|"     The objective of the study is to evaluate the product performance of visual acuity of the     Bausch + Lomb investigational daily disposable contact lenses compared to the currently     marketed Johnson & Johnson Acuvue Moist contact lenses.   "
159784|NCT01192113|"     This is an open-label, randomized, multi-center clinical trial to evaluate the safety and     efficacy in peripheral neuropathies patients treated with Mecobalamin Injection   "
159785|NCT01192100|"     The purpose of this study is to assess whether the daily addition of a protein-rich breakfast     leads to beneficial changes in appetite control, food intake regulation,and cognitive     function in overweight & obese 'breakfast skipping' young women.   "
159786|NCT01192087|"     The ACCEPT (A(denoid) c(ystic) c(arcinoma), E(rbitux, and) p(article) t(herapy))-trial is a     prospective, monocentric phase I/II feasibility trial evaluating toxicity and efficacy in the     combined treatment of intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost     with the epidermal growth factor receptor (EGFR) antibody cetuximab. The primary objective of     the study is to explore the toxicity of the combined modality regimen consisting of heavy ion     therapy / IMRT and EGFR antibody immunotherapy, by assessing the rate of patients with     mucositis or any other toxicity of severity grade 3 or 4 according to NCI CTCAE V. 4.     Secondary endpoints include local control, distant control, overall disease-free survival,     overall survival   "
159787|NCT01192074|"     This is a data base building project on the use of pre-procedure ultrasound for the     performance of labor epidural pain relief and spinal anesthesia for cesarean deliveries. Data     collection includes ultrasound measured depth, actual needle depth, angle of ultrasound     probe, actual needle angle, success rates, patient height and weight, number of attempts     needed to place the epidural needle or spinal needle. Currently we are looking at the     agreement between ultrasound determined depth of the epidural space or intrathecal space with     actual needle depth.   "
159801|NCT01191892|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet     known whether giving carboplatin and gemcitabine hydrochloride is more effective with or     without vandetanib as first-line therapy in treating urinary tract cancer.      PURPOSE: This randomized phase II trial is studying giving carboplatin together with     gemcitabine hydrochloride and to see how well it works when given with or without vandetanib     as first-line therapy in treating patients with locally advanced or metastatic urinary tract     cancer.   "
159802|NCT01191879|"     The purpose of this study is to compare p53-induced genes activation as possible markers     differentiating between patients presenting with acute myocardial infarction and controls.   "
159864|NCT01191060|"     Objective of this study is to determine if, in the era of novel drugs, high dose therapy     (HDT) is still necessary in the initial management of multiple myeloma in younger patients.     HDT as compared to conventional dose treatment would be considered superior if it     significantly prolongs Progression-free survival (by at least 9 months).   "
159788|NCT01192061|"     Evidence has accumulated that systemic and ocular mechanisms, responsible for regulating     blood flow in the area of the optic disc, such as reduced ocular perfusion pressure, abnormal     autoregulation and vascular dysregulation may be involved in the pathogenesis of normal     tension glaucoma (NTG). Defective cardiovascular neuroregulation has been advocated as a     possible one of the main systemic contributing factors in the etiology of NTG. Based on the     results of previous studies, the hypothesis has been posed that patients with NTG have an     impaired diurnal heart rate variability (HRV) or high activity of the sympathetic component     of autonomic nervous system (ANS) and endothelial dysfunction. Impaired balance of ANS,     resulting in increased demand for oxygen in the tissues and subsequent low threshold of     hypoxia in all organs (including the eye) can be an important link in the pathogenetic     pathway of NTG, making the optic nerve more sensitive to small and short-term changes in     perfusion pressure and prone to damage even under a statistically normal intraocular     pressure (IOP).      The aim of this study is to evaluate the activity and characteristics of the following     systems: the central ANS (through a 24-hour analysis of heart rate variability and blood     pressure), peripheral vascular system (through the analysis of the post-occlusive hyperemia     reaction within the distal part of left upper limb) and the local retrobulbar circulation as     measured by color Doppler imaging (CDI) in patients with NTG and healthy volunteers. The     correlations between all above systems, as well as between them and the structural and     functional parameters of the optic nerve, and the retina in both groups will be also     analyzed.   "
159789|NCT01192048|"     Congenital heart disease (CHD) is the most common type of birth defect but the cause for the     majority of cardiac birth defects remains unknown. Numerous epidemiologic studies have     demonstrated evidence that genetic factors likely play a contributory, if not causative, role     in CHD. A few genes have been identified by us and other investigators using traditional     genetic approaches, but these genes only account for a small portion of the non-syndromic     CHDs. Therefore, we are now utilizing whole exome sequencing (WES), with the addition of more     traditional genetic techniques such as chromosomal microarray or traditional linkage     analysis, to identify genetic causes of familial and isolated CHD. With WES we are able to     sequence all of the genes of an individual and apply different data analysis techniques based     on whether we are analyzing a multiplex family or a cohort of trios (mother, father and child     with CHD) with a specific isolated CHD. Therefore, WES is a robust method for identification     of novel genetic causes of CHD which will have important diagnostic and therapeutic     consequences for these children.   "
159790|NCT01192035|"     BACKGROUND: Since 1996 the combination of three or more drugs has been the mainstay of human     immunodeficiency virus (HIV) treatment. The most important types of drugs are called     nucleotide reverse transcriptase inhibitors (NRTIs), non-nucleotide reverse transcriptase     inhibitors (NNRTIs) and protease inhibitors (PIs) Response to treatment is measured as     increasing CD4+ cell count and decreasing HIV viral load. A major problem is the development     of resistance. NNRTIs are recommended as part of first-line treatment of HIV in Africa but     many Africans have a slower NNRTI clearance than Caucasians making them more susceptible for     development of resistance in case of treatment interruptions. PIs might therefore be a better     option in an African setting with low adherence.      AIM: To evaluate two different treatment regimens in HIV-1 infected patients:      A) A NNRTI (efavirenz/nevirapine) based regimen and B) A PI (ritonavir-boosted lopinavir)     based regimen with regard to treatment outcomes. HYPOTHESIS: Treatment with a PI will be     superior to treatment with a NNRTI due to less development of resistance.      METHODS: Treatment-naïve adult HIV-1 patients enrolled in an existing cohort The West African     Retrovirus and Acquired Immune Deficiency (WARAID) cohort in Guinea Bissau with CD4+ cell     count ≤ 350 cells/µL and/or clinical signs of immune suppression (World Health Organization     (WHO) clinical stage 3 or 4) will be randomised 1:1 to: Treatment A: 2 NRTIs (lamivudine and     either zidovudine or stavudine) and 1 NNRTI (efavirenz or nevirapine) or Treatment B: 2 NRTIs     (same as in treatment A) and 1 PI (ritonavir-boosted lopinavir). Primary outcome: Viral load     suppression <400 copies/ml 12 months after enrolment.      PERSPECTIVES: Guidelines for treatment of HIV in Africa are more or less a copy of the     guidelines used in Europe and North America. Genetic differences in pharmacokinetics, more     women infected in Africa and difficulties ensuring good adherence mean that results obtained     from Caucasian patients are not directly transferrable to African patients. The results of     this study will hopefully help guiding the treatment of HIV in Africa in the future. The     investigators believe the HIV infected people in West Africa deserve the same evidence-based     medicine as in developed countries.   "
159791|NCT01192022|"     The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection     surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original.     Hemostatic efficacy will be evaluated intraoperatively after application of randomized     treatment.   "
159792|NCT01192009|"     Leucine supplementation is widely known for promoting strong influence on skeletal muscle     remodeling. This study aims to evaluate the effect of leucine supplementation on     disuse-induced skeletal muscle atrophy.   "
159793|NCT01191996|"     The purpose of the study is to determine the safety and tolerability, dose-limiting     toxicities, maximum tolerated dose, and recommended therapeutic dose of intravenously     administered MIS416 weekly in patients with chronic progressive multiple sclerosis.   "
159794|NCT01191983|"     This single arm, open label study will assess the efficacy, safety and tolerability of     methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in     participants with chronic kidney disease (CKD) secondary to diabetes. Participants who are     not on dialysis and not currently treated with erythropoiesis stimulating agents (ESAs) will     receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (Q4W). The     starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta     will be adjusted according to hemoglobin levels. Anticipated time on study treatment is 28     weeks.   "
159803|NCT01191866|"     Primary Objective is to evaluate the influence of psychosocial interventions in the treatment     of children and adolescents with type 1 diabetes mellitus by measuring the connection between     these interventions to quality of life and to metabolic control. Secondary Objective is to     provide an opportunity, through quality of life (QOL) questionnaires, for enhanced     communication between the patient, family and diabetes care team and also an opportunity to     resolve negative issues.   "
159821|NCT01191632|"     The efficiency of T cell based immunotherapies is affected by the insufficient migration and     activity of tumor specific effector T cells in the tumor. Aim of this phase I/II clinical     trial is to evaluate whether a neoadjuvant, low dose radiotherapy can improve T cell     connected anti tumor immune response in colorectal liver metastases.      The primary endpoint is the number of tumor infiltrating T cells. Furthermore the T cell     activity in situ, the number of regulatory T cells and the frequency of tumor reactive T     cells in the blood and bone marrow will be examined.   "
160084|NCT01188161|"     Subjects will be secured and rotated in a whole body gyroscope, similar to a flight trainer     for astronauts. The rotations will be in many directions and the speed will be at 90 deg/sec.     The effects of this rotation on the ability to stand upright will be measured.   "
159795|NCT01191970|"     Presently, the literature addressing the relationship between epidural analgesia and     likelihood of breast-feeding is inconclusive. Numerous studies have found that epidurals,     administered prior to vaginal delivery of a full-term, healthy neonate, significantly     decrease lactation success at follow-up times ranging from 24 hours to 6 months postpartum.     One proposed mechanism is that analgesics, by decreasing maternal pain during labor, decrease     maternal endorphin production and result in the transmission of lower endorphin levels to the     neonate during breast-feeding. Lower endorphin levels, in turn, may render the neonate less     likely to suckle optimally. Other studies have found that epidural analgesia does not     significantly decrease lactation success when used during the vaginal delivery of a     full-term, healthy neonate.      Although most studies to date have compared the breast-feeding success of epidural recipients     and non-recipients at various points postpartum, they do not specifically note whether     deficient feeding behaviors on the part of the infant contribute to failed breast-feeding.     The present study uses the LATCH assessment tool to score the infant's ability to latch onto     the breast and the presence of audible swallowing, as well as the mother's level of physical     comfort with breast feeding, whether she can successfully position the infant for feeding on     her own, and whether her nipples are inverted, everted, or flat. Thus, the LATCH assessment     enables the separation of multiple factors that may contribute to breast-feeding failure. A     multivariate regression analysis will determine how strongly the probability of     breast-feeding at hospital discharge correlates with epidural duration, LATCH scores, and     beta-endorphin concentrations in colostrum.   "
159796|NCT01191957|"     The purpose of this prospective phase III, open-label, randomized multicenter study is to     evaluate whether Acute Myeloid Leukemia (AML) elderly patients in Complete Remission (CR)     undergoing allogeneic hematopoietic stem cell transplantation after a reduce toxicity     conditioning regimen (I.V. BuFlu) as compared to the conventional I.V.      BuCy2 program will experience:        1. A lower transplant-related mortality (TRM) at 1 year after Hematopoietic Stem Cells          Transplant (HSCT)        2. A similar anti-leukemic activity and a similar or better safety profile, in terms of:             -  Early and/or late graft rejection             -  Hematopoietic and immunologic recovery             -  Chimerism             -  Toxicity and incidence of Veno-occlusive Disease (VOD)             -  Acute (aGvHD) and chronic graft-versus-host disease (cGvHD)             -  Cumulative incidence of TRM at +100 days and 2 years after transplant             -  Cumulative incidence of relapse by 1 and 2 years after transplant             -  Event-free (EFS) and overall survival (OS) by 1 and 2 years after transplant   "
159797|NCT01191944|"     The objective of this trial is to evaluate non-inferiority of pramipexole Extended release to     Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease     Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .   "
159798|NCT01191931|"     Study design:      -The study will be a phase I like study to assess the extent to which prostate HistoScanning     (PHS, the index test) can identify and characterize foci of prostate cancer when compared to     histological samples harvested during radical prostatectomy (the reference test). The study     will comprise 3 steps: first, defining the most suitable method for matching the TRUS     (TransRectalUltrasonography) to histology (step 1); second, refining the algorithms (training     set); third, verification of the PHS performances (test set).      Study objectives:        -  Primary Objective:             -  To evaluate the extent to which PHS can discriminate between malignant lesions of               the prostate versus non-malignant tissue in 3D RF TRUS data using radical               prostatectomy histological step sectioning as the reference test.        -  Secondary Objectives:             -  To adapt and refine PHS tissue characterisation algorithms using RF data that were               previously developed using grey-level data as input.             -  To assess the accuracy of PHS in predicting the volume of prostate cancers               determined by histology.             -  To assess the ability of PHS to rule in or rule out the presence of cancer > or =               0.5 cc and of > or = 0.2 cc as determined by histology.             -  To evaluate the ability to discriminate primary Gleason pattern 4 and 5 versus 3 or               less in tumours > or = 0.5 cc and > or = 0.2 cc.             -  To assess the ability of PHS to correctly risk stratify patients.   "
159799|NCT01191918|"     There is a high rate of partial response to standard thymoleptic medication. In this study     the investigators want to evaluate the safety and efficacy of donepezil as adjunctive     treatment to mood stabilizers in bipolar disorder with acute mania. The investigators     hypotheses were that there would be greater mean reduction in manic symptoms with donepezil     augmentation of lithium compared with placebo.   "
159800|NCT01191905|"     Acute kidney injury (AKI) is a common and serious problem in critically ill patients, and is     known to be an independent risk factor for mortality. Among the various etiologies of AKI,     sepsis or septic shock is the most frequent contributing factor especially in an intensive     care unit setting. Also, the mortality of septic AKI in these patients still remains     extremely high despite recent marked therapeutic advance.      Given the physiologic superiority of continuous renal replacement therapy (CRRT) on uremia     and volume control, it has become the modality of choice in critically ill patients with AKI.     In addition, CRRT can theoretically provide immunohomeostasis through the convective and     adsorptive removal of various immune mediators. Although the pathophysiology of septic AKI     remains elusive, it has become increasingly recognized that many pro- and anti-inflammatory     mediators, such as TNF, IL-6, IL-8 and IL-10, play an important role in this process.     Therefore, it has been speculated that the reduction of cytokines by increasing CRRT dose in     patients with septic AKI may reduce mortality risk. Even though recent two large scale     randomized controlled trials, ATN and RENAL study, have failed to show the difference in     survival rate between the clearance of 20~25 ml/kg/hr and 35~40 ml/kg/hr, none of these     studies were designed to elucidate the survival benefit of high intensity CRRT in patients     with septic AKI. Moreover, the optimal target CRRT dose in these patients is not well     established and may be even higher than 35~40 ml/kg/hr in terms of septic AKI. Indeed, recent     several uncontrolled trial have shown the survival benefit of high intensity CRRT in these     patients.      To further explore the effects of high dose CRRT on survival of critically ill patients with     septic AKI, the investigators will conduct a multicenter prospective randomized controlled     open-label trial which compares the difference in survival rate between 1:1 balanced     pre-dilution CVVHDF at 80 vs. 40 mL/Kg/hr for initial 72hrs after the start of CRRT. The     primary end-point of this study is the effect of high volume pre-dilution CVVHDF on 28-day     survival rate. The secondary end-point is 60- and 90-day mortality, ICU and in-hospital     mortality, duration of CRRT and renal replacement therapy, duration of mechanical     ventilation, cytokine removal rate at 12h after the initiation of CRRT, and changes in SOFA     and APACHE II score at 72h after the initiation of CRRT. This is a superiority trial which     aims to demonstrate a reduction of 20% or more in mortality rate. For this purpose, at least     109 subjects (a total of 218) would be required for each group if type I error rate is 5% and     type II error is 20% given 25% of drop-out rate during the study period. Block randomization     will be used by means of a dedicated website.      There are still conflicting data on the optimal target dose of CRRT in patients with septic     AKI. Our study will address this issue to answer the unresolved question on the effect of     high dose CRRT.   "
160229|NCT01186276|"     This study will assess whether dietary fiber supplements can reduce the production of     chemicals which are produced by colon bacteria and normally excreted from the body by the     kidney, but build up in the body in patients on hemodialysis.   "
159804|NCT01191853|"     Background:      - Seasonal influenza is a major health problem whose impact is typically reduced by     vaccination. The H1N1 (swine flu) influenza virus is an emerging pathogen that has the     potential to cause devastating illness and even death in the coming months. Currently, there     are limited data on the cellular and molecular immune responses in adult recipients of either     the seasonal or the H1N1 influenza vaccines.      Objectives:      - To obtain blood and nasal wash samples and perform laboratory studies to characterize the     immune response in healthy adult volunteers at baseline and after immunization with the     seasonal or H1N1 influenza vaccines.      Eligibility:      - Adult employees at least 18 years of age of the NIH Clinical Center who are deemed healthy     by a brief medical history and physical examination and routine blood testing.      Design:        -  Before the start of the influenza season, volunteers will receive either the seasonal          influenza vaccine or the H1N1 vaccine when it becomes available. If the H1N1 vaccine is          available at the start of the season, volunteers will receive both the seasonal vaccine          and the H1N1 vaccine.        -  Blood will be drawn over an 8-week period. Volunteers must not eat anything for 8 hours          prior to the blood draw. The sequence of the blood draws is as follows: 2 weeks before          vaccination; right before vaccination; and 1, 7, 14, 28, and 60 days after vaccination.        -  Two to four nasal washings will be collected by a nurse before volunteers receive the          vaccination(s) and 28 days after the vaccination.        -  Prevaccine and postvaccine blood and nasal wash samples will be compared to determine          volunteers immune responses.        -  Research samples will be stored indefinitely and will be used strictly for laboratory          experiments.   "
159805|NCT01191840|"     The purpose of this study is to accurately determine the length of appropriate drug treatment     for staphylococcal blood stream infection. The study seeks to address important information     about the management of staphylococcal blood stream infections.   "
159806|NCT01191827|"     This study aims to determine how clozapine treatment improves neuronal measures of sensory     gating in subjects with schizophrenia.   "
159807|NCT01191814|"     Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr     plastic stents. When compared to plastic stents, randomized trials have shown longer patency     and fewer stent-related complications for CSEMS. The investigators hypothesize that placement     of CSEMS would be a better treatment option for preoperative biliary decompression in     patients with pancreatic cancer.   "
159808|NCT01191801|"     This study compared treatment groups of patients treated with vosaroxin and cytarabine versus     patients treated with placebo and cytarabine.   "
159809|NCT01191788|"     The investigators will investigate whether group Cognitive Behavioral Therapy (CBT) for     depression, with alcohol and other drug (AOD) treatment counselors leading the groups, is     effective and cost effective in treating depression. If so, it could substantially increase     access to appropriate mental health care. 360 clients with Beck Depression Inventory-II     scores > 17 who are being treated in a single public sector AOD treatment organization will     receive one of two conditions: (1) usual care residential AOD treatment (UC); (2) usual care     AOD residential treatment plus a 16-session course of group CBT delivered by trained AOD     counselors (CBT). Data will be analyzed using an intent-to-treat model. The investigators     will collect data on the service-level costs and health effects associated with UC and CBT,     and will calculate the incremental cost per unit of depression and AOD improvement, compared     to UC.   "
159810|NCT01191775|"     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. The     purpose of this research study is to evaluate the safety of the investigational drug PNT2258     in patients with advance tumors and see how it acts in the body.   "
159811|NCT01191762|"     The hypothesis underlying this study is that phosphate interferes with PTH-mediated calcium     reabsorption in the distal nephron and thereby necessitates supranormal [PTH]to maintain     normocalcemia in chronic kidney disease. This study will examine the hypothesis with measures     of phosphate homeostasis and calcium reabsorption. A double-blind trial of the intestinal     phosphate binder sevelamer carbonate will be employed to examine whether reductions in     phosphate influx alter distal nephron phosphate concentration and the [PTH] required for     calcium reabsorption in the expected manner.   "
159812|NCT01191749|"     The goal of this clinical research study is to determine the effectiveness of alemtuzumab in     patients with aplastic anemia, MDS, or T-Cell large granular lymphocytic leukemia. The safety     of alemtuzumab will also be studied.   "
159813|NCT01191736|"     Bystander CPR improves survival from Out of Hospital Cardiac Arrest. This study examines the     efficacy of ultra-brief video training for Hands-Only CPR. Subjects were randomized to one of     four training conditions, then assessed for CPR skills retention.   "
159814|NCT01191723|"     Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered     by Oral Inhalation) with Moxifloxacin and Placebo.   "
159815|NCT01191710|"     The aim is to explore whether the incidence of progesterone rise in the late follicular phase     differs between GnRH-agonist and GnRH-antagonist protocols for IVF and whether this has an     impact on the probability of pregnancy achievement.   "
159816|NCT01191697|"     The purpose of this study is to determine the safety and effectiveness of a combination of     chemotherapy, capecitabine and oxaliplatin, plus the antibodies bevacizumab and trastuzumab.     Trastuzumab (also called Herceptin) is an antibody that attacks HER2 protein in tumor cells.     Bevacizumab (also called Avastin) works by slowing or stopping the growth of cells in cancer     tumors by decreasing the blood supply of the tumors. If blood supply is decreased, oxygen and     nutrients that are needed for tumor growth are decreased. The chemotherapy used in this trial     is called CAPOX, which is an abbreviation of capecitabine and oxaliplatin.   "
159817|NCT01191684|"     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective     immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with colorectal, stomach, or pancreatic cancer.   "
159818|NCT01191671|"     The first years of life are considered essential to child development, as there is greater     brain growth and formation of more neural connections. Therefore, the stimulation of children     in various fields of development becomes relevant to the acquisition of knowledge and skills.   "
159819|NCT01191658|"     The circumference of a person's neck is a useful predictor of difficulty of insertion of a     breathing tube.   "
159822|NCT01191619|"     The ProSeal laryngeal mask airway (PLMA) is one of the alternative methods for effective     airway management. It is an advanced form of laryngeal mask airway(LMA) with a softer and     larger cuff to improve sealing and a drain tube to permit venting of the stomach. However,     the larger cuff is more difficult to save space for insertion in the mouth and is more likely     to fold over. Particularly, a relatively large tongue, a floppy epiglottis, a cephalad and     more anterior larynx and frequent presence of tonsillar hypertrophy may disturb PLMA     insertion in pediatric patients. The manufacturer recommends inserting PLMA using digital     manipulation or with an introducer, but these techniques have lower success rates compared to     those of LMA insertion.      McIvor blade is a tongue retractor with a thin and curved blade and a flat handle. It is used     to secure the operating field by pressing tongue during tonsillectomy. The investigators     hypothesized that McIvor blade would provide more space in the mouth for PLMA insertion, and     therefore it could improve the PLMA insertion as well as reducing injuries to the pharyngeal     wall. The investigators compared the success rate and the incidence of complications of the     digital technique with those of McIvor blade-guided insertion by unskilled anesthesia     residents.   "
159823|NCT01191606|"     The aim of this study is to determine the effects of pressure controlled ventilation during     protective one lung ventilation on blood gases, airway pressures and hemodynamic variables     compared with volume controlled ventilation.   "
159824|NCT01191593|"     The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at     reducing pain and morphine consumption after revision knee arthroplasty.   "
159825|NCT01191580|"     The investigators propose a randomized clinical trial to compare the efficacy of     Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), and Brief Supportive     Psychotherapy (BSP), in improving depressive symptoms, psychosocial functioning, and quality     of life among patients with breast cancer and major depressive disorder (MDD).   "
159851|NCT01191229|"     The study is being conducted to collect information about visual outcomes and participant     satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared     with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S.     Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual     correction of aphakia (replacing a removed lens in the eye) in adults.   "
159881|NCT01190813|"     The purpose of this study is to evaluate the efficacy and safety of oral levodopa and     patching versus oral placebo and patching as treatment for residual amblyopia in children 7     to <13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.   "
159826|NCT01191567|"     Wounds have long been a source of suffering for unfortunate victims and in recent years new     complementary methods have been developed in areas where traditional wound treatment has been     insufficient. Treating wounds with negative pressure, Vacuum assisted closure® [VAC], is a     relatively new method of treatment and knowledge about its effect on patients is limited.      Earlier studies haven't been able to answer the question about which groups of patients that     are in most favour of the treatment and what impact the treatment has on the patient's     quality of life.      It is important with further research since an effective and mild wound treatment can     decrease suffering and increase quality of life for the patient. Wound treatment that does     not lead to an achieved treatment goal can lead to a risk for the patient and should be     avoided.      The project consists of 4 part studies: Study 1 and 2 are chart review studies of a     consecutive series of patients treated with VAC at Södersjukhuset during a 3 year period. The     patients are described on the basis of medical, surgical and demographical factors. Outcome     is treatment results and risk factors for a treatment failure.      Study 3 and 4 are clinical randomised studies with the aim of studying whether treatment with     VAC provides a faster and more effective healing of acute and postoperative wounds, and in     what way the treatment affect the quality of life and pain of the patients, compared to     conventional treatment.   "
159827|NCT01191554|"     Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic     acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and     transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently     multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown     that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized     study focus on TA in primary valve surgery. The aim of this prospective, double-blinded,     randomized trial is to compare two dosing regimens of TA during primary valve surgery on     perioperative blood loss and allogeneic blood transfusion.   "
159828|NCT01191541|"     Several groups, especially the PETHEMA group (in their LPA96 and 99 trials), obtained low     relapse rates in newly diagnosed Acute Promyelocytic Leukemia (APL) patients by combining     ll-transretinoic acid (ATRA) and anthracyclines without Ara-C, suggesting that avoiding Ara-C     in the chemotherapy of APL reduced treatment toxicity without increasing relapses. While the     relapse rate for the children with white blood cell(WBC) counts greater than 10×109/L at     presentation were higher than those WBC counts less than 10×109/L (31% and 3.5%,respectively)     in the LPA96 and 99 trials. A recent adult randomized trial show that avoiding Ara-C leads to     an increased risk of relapse in the APL patients with WBC counts less than 10×109/L. The role     of the Ara-C remains controversial. And there are very limited data reported on children with     APL so far.   "
159829|NCT01191528|"     To compare two ways to test breathing after surgery in acute care setting. One method tests     oxygen level of the blood, and one method will test oxygen and the carbon dioxide that is     breathed out.   "
159830|NCT01191515|"     The purpose of this study is to evaluate the near and intermediate visual outcomes of     patients who have undergone routine cataract surgery (removal of cloudy crystalline lens)     with phacoemulsification (the break-up and removal of cloudy lens) and monofocal IOL ( a     plastic lens implanted to replace eye's natural lens) placement in the capsular bag in at     least one eye.   "
159831|NCT01191502|"     The purpose of this study is to evaluate visual acuity in different lighting conditions     (daylight and night time) and distances (distance, near and intermediate), and the     independence of glasses, in patients who have had binocular implantation of the Tecnis     Multifocal IOL or the Crystalens™ HD Accommodating IOL.   "
159832|NCT01191489|"     The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the     reintubation rate. Post-extubation respiratory failure risk will be stratified (as the     randomization). In high risk patients high flow conditioned oxygen therapy will be compared     with with not conditioned non-invasive mechanical ventilation. In low risk patients     comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.   "
159833|NCT01191476|"     This study is being performed to compare the cost of anesthetic techniques with sevoflurane     (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion [TCI])     versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing     elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.   "
189733|NCT00333034|"     The primary objective is to assess the efficacy and safety of etanercept 50 mg administered     once weekly in subjects with psoriasis over 12 weeks.   "
159834|NCT01191463|"     Iron deficiency is estimated to affect about one fifth of the world's population, and women     and children are among the most severely affected. Evidence is mounting that iron deficiency     anemia adversely affects brain development with measurable effects on children's behavior,     motor development and cognition. In Hisar district of Haryana state, north- India, 58% of     school age children (6-10 years) are anemic, 49 % are iron deficient whereas 40 % have been     found to be anemic due to iron deficiency. Iron bioavailability calculated using algorithms     in regional diets ranged from 3.2 to 4.6 percent. Mungbean (Vigna radiata L.) is the third     most important legume crop of India. It is a high potential legume crop with 4-8 mg of iron     and known as a nutritious and healthy legume. Ascorbic acid is a potent enhancer of iron     absorption in humans which can counteract the inhibitory effect of phytic acid and     polyphenols. Guava is a popular and easily available fruit for this community having 200- 300     mg/100g of ascorbic acid. We will conduct a randomised controlled trial in school age     children (6-10 years) in Haryana state of India, to determine the efficacy of local vitamin-C     rich fruit guava with mungbean based meal on iron status of rural Indian children.      Objective: To assess the effect of mungbean based test meal on iron status (as body iron     stores, defined and calculated by the ratio of serum ferritin and serum transferrin receptor)     of school age children (6-10 years) with and without the consumption of guava, a vitamin C     rich fruit, in a school feeding program for seven months.      Study population: Three hundred school children aged between 6-10 years will be recruited     from two government school of Mangali village situated in Hisar district of Haryana state.      Study design: This intervention study will be carried out in a randomized controlled design.     Main study parameters/endpoints: Primary outcome will be the measurement of body iron stores     (mg/kg of body weight) based on the ratio of serum transferrin receptor to serum ferritin.   "
159835|NCT01191450|"     The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg +     amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial     hypertension.   "
159836|NCT01191424|"     The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of     Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the     NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP,     Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a     free combination of BDP DPI plus FF DPI licensed products after a morning dose administration     of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic     patients.   "
159837|NCT01191411|"     Colon cancer (CRC) is a leading cause of cancer death in the United States. Screening can     prevent CRC death, but screening rates are suboptimal, especially for vulnerable populations     such as those with limited or no health insurance. This striking public health challenge     demands urgent implementation of evidence-based strategies to reduce avoidable CRC death.      Prior research has shown that a direct-to-consumer strategy of inviting patients by mail to     complete CRC screening may result in increased rates of screening completion. However, this     approach has not been tested extensively in vulnerable populations, such as the     under/uninsured, and minority populations often cared for by safety-net health systems.     Further, it is unclear whether patients are more likely to participate in one CRC screening     test versus another. Knowing this is important to designing programs for increasing     screening. For example, the planning and resources required for a screening program with     colonoscopy--which is a sensitive but invasive and expensive test--are very different from a     program with that uses stool testing to detect microscopic blood such as an immunochemical     stool blood test--which is a less sensitive, but non-invasive and cheap test.      Also, it is possible designing a program with a less sensitive, but more acceptable test     could prevent more CRC death if participation in screening is test specific. For example, if     many more patients participate in an immunochemical stool blood test based program than a     colonoscopy based program, even though the immunochemical stool blood test is less sensitive,     the program may save more lives because more patients are reached.      The aims of this trial are to:      Aim 1. Deliver CRC screening services (mailed invitation to screening, telephone reminders,     and systematic clinical follow up) to uninsured, unscreened patients cared for by the     safety-net health system serving Tarrant County, Texas. Patients will be invited to either:        1. Complete a free home-based, non-invasive immunochemical stool blood test        2. Complete a free colonoscopy      Aim 2. Evaluate program outcomes, including screening rates, cancers detected, and program     costs.      The primary outcome is screening completion.   "
159838|NCT01191398|"     The purpose of this study is to determine if the antisialagogues (anti-salivary agents),     Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating patients     with Ketamine for procedural sedation in the emergency department or abscess clinic. The     investigators will measure salivary flow rate by collecting oral secretions by oral     suctioning over a 30 minute time period starting with the administration of Ketamine. The     investigators hypothesize that patients who receive either atropine or glycopyrrolate will     have fewer oral secretions than patients who receive placebo.   "
159839|NCT01191385|"     This study is an international prospective, open-label, multi-center, non-interventional     study. The protocol will allow enrollment of all patients with diagnosis of HCC in whom a     decision to treat with sorafenib has not been made at time of study enrollment. All patients     will be followed-up until withdrawal of consent, lost to follow-up, death, or the end of the     study. Detailed information concerning the past medical/surgical history, performance status,     methods of diagnosis and staging, etc. of patients with HCC will be collected, and practice     patterns of the physicians involved in the care of patients with HCC under real-life     conditions will be evaluated.   "
159840|NCT01191372|"     The purpose of this study is to examine the safety, tolerability and the way the body handles     various single and multiple doses of ARC19499 in patients with hemophilia.   "
159841|NCT01191359|"     Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS     Birch in regard to pharmacodynamic efficacy and tolerability.   "
159842|NCT01191346|"     The purpose of this research study is to see if a higher strength MRI procedure provides     better images to use in planning radiation treatments for patients with brain tumors in the     future.   "
159843|NCT01191333|"     The purpose of this multi-site trial is to determine if repetitive Transcranial Magnetic     Stimulation (rTMS) helps people with depression who have not been helped by medications or     who have not been helped enough by medications.   "
159844|NCT01191320|"     The purpose of this study is to determine the effect the investigative drug has on glycemic     control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism   "
159845|NCT01191307|"     The ASK CHILDREN study is intended to aid in future development of various neurologic devices     (i.e. neuroprostheses). The ASK CHILDREN study seeks to use study information obtained to     identify more efficient strategies in the evaluation and review of neuroprostheses regulated     by the Agency.   "
159846|NCT01191294|"     The investigators will design a curriculum for visual screening for melanoma and skin biopsy     procedure, based on the mastery learning model, using simulators and web-based didactic     instruction for medical students and internal medicine residents. This requires having a skin     simulation model that presents a range of lesions from benign nevus to atypical nevus to     melanoma in a distribution and density that mimics the clinical findings of those with 2 skin     tones: fair-skin non- Hispanic white and Hispanic.   "
159863|NCT01191073|"     In the clinical trial, the Computer Aided Design/Computer Aided Manufacturing (CAD/CAM)     fabricated removable partial dentures (RPD's) are evaluated on casts and clinically compared     with a traditional fabricated RPD for 50 consecutive patients.      During 5 years the patients are in a follow-up program in order to judge long-term stability,     loss of retention, fractures, … of both groups of dentures.   "
159847|NCT01191281|"     The purpose of this three-year study is to develop, implement, and pilot test a culturally     appropriate, multi-component nutrition intervention for people living with HIV and food     insecurity in Honduras, which is among the Latin America nations with the highest HIV     prevalence rates. The investigators specific aims are to:        1. Explore the relationships between food security, nutrition, and HIV treatment access,          utilization, and adherence, and examine key mediators and moderators of these          relationships.        2. Develop a multi-component nutrition intervention to address food insecurity among          Honduran HIV+ individuals and their families.        3. Evaluate the preliminary effectiveness of the intervention on (1) food security and          nutritional status; (2) HIV care retention (clinic attendance), uptake of ART when          recommended, and ART adherence; and (3) clinical outcomes (CD4 count, ART side effects,          and opportunistic infections).        4. Examine key mediators and moderators of the intervention effects from among          characteristics of the patient, household, and contextual setting.   "
159848|NCT01191268|"     The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to     Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in     participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.   "
159849|NCT01191255|"     This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD     dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.   "
159850|NCT01191242|"     Methadone has been an effective and inexpensive therapy in the management of chronic pain and     opioid dependence. However it has been associated with sudden, unexpected deaths. Two     mechanisms have been suggested, increased drug concentration in the blood, and a change in     the heart rhythm. This study will look at blood samples for drug levels and genetic     components and EKG's (a noninvasive test which reveals heart rhythm). There will be no     intervention.   "
159852|NCT01191216|"     This phase I trial is studying the side effects and best dose of giving 1-methyl-d-tryptophan     and docetaxel together in treating patients with metastatic solid tumors. Biological     therapies, such as 1-methyl-d-tryptophan, may stop the growth of tumor cells by stimulating     the immune system and by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving 1-methyl-d-tryptophan     with chemotherapy may kill more tumor cells.   "
159853|NCT01191203|"     The IUD is an extremely effective method of contraception yet few women use it worldwide.     Considered safe to use in HIV+ women, few studies have evaluated its use among those using     antiretroviral therapy. The only prior randomized trial looking at the IUD compared to     hormonal contraception noted a high rate of IUD discontinuations. Understanding IUD     acceptability and continuation is critical to improve utilization.        -  Objective 1: Determine WHO medical eligibility and the willingness for IUD placement        -  Objective 2: Compare method-related side effects and adverse events        -  Objective 3: Assess the 1-year acceptability and continuation rates      Methods: To address our objectives the investigators have designed a two Phase Study:        -  A cross-sectional screening to evaluate contraceptive medical eligibility and          desirability        -  A randomized controlled trial that will compare acceptability and adherence to DMPA          compared to the Copper IUD: enrolling 200 women stable on antiretroviral therapy to          follow for 1 year   "
159854|NCT01191190|"     Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be     eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4     week cycles. The primary endpoint is to determine the complete response (CR) to therapy and     the secondary endpoints will assess the safety and tolerability of the regimen, the impact of     the treatment on progression free, treatment free, overall survival, and pharmacokinetics of     ofatumumab. Patients will receive allopurinol for tumor-lysis prophylaxis and antimicrobial     prophylaxis.   "
159855|NCT01191177|"     The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in     normalizing liver function in patients who have parenteral nutrition associated liver     disease. The investigators believe that patients who take oral fish oil will normalize liver     function faster than those who do not   "
159856|NCT01191164|"     Background: Recent single arm studies have suggested that partial breast irradiation (PBI),     delivered in a relatively short overall treatment time of a few days, may be an effective     alternative to adjuvant whole breast irradiation (WBI) delivered over a number of weeks.     Several PBI modalities and techniques have been investigated, including interstitial     brachytherapy and external beam radiation therapy, most often given over the course of one     week of twice daily outpatient treatments. One randomized study has shown equivalency between     WBI and PBI using brachytherapy. There are currently three large phase-III randomized studies     comparing PBI to WBI.      Permanent Breast Seed Implant (PBSI) is the newest PBI technique which has been piloted at     the Odette Cancer Centre (OCC) in Toronto. The main advantage of this technique is that it     requires only one out-patient procedure. The treatment is administered by implanting     radioactive Palladium (103Pd) seeds into the tumor bed region in a 1 to ½ hour outpatient     procedure, after which the patient is discharged home to resume her normal living activities.     This PBI procedure was shown to be well tolerated with minimal acute toxicity. Estimated     partner radiation exposure was well within internationally acceptable levels. Subjects with a     seroma >2cm were, however, excluded.      Hypothesis: PBSI is a feasible, safe, and acceptable treatment option for the subject and her     partner in the context of medical practice and resources in BC.      Objectives: In subjects who have undergone breast conserving surgery for early breast cancer:        1. To determine the technical feasibility of PBSI in BC        2. To measure the subject's partner in terms of radiation protection        3. To evaluate acceptability of PBSI by the subject        4. To assess resource requirements for PBSI      Method: This is a single arm feasibility study. Five women who had undergone breast     conserving surgery for breast cancer with low risk of local recurrence will be accrued. This     study will adhere to a detailed written protocol for radiation measurements and protection.      Subjects will undergo PBSI within 4-14 weeks from last breast surgery. The procedure will be     performed in an outpatient setting, under conscious sedation and local anesthesia, by a team     with a wide brachytherapy experience. The technique used in this feasibility study will be     based on the OCC technique. It is intended that two oncologists and one physicist will spend     2-3 days at the OCC to acquire detailed and firsthand knowledge of the technique as     implemented at that centre.      The OCC technique is US-based; in this study, however, an additional CT-assisted planning     component will be investigated building on the experience of the VIC team which conducted the     BC Cancer Agency Vancouver Island Centre's pilot study of CT-based multi-catheter     brachytherapy PBI.      Systemic therapy will be according to BCCA guidelines; however, subjects requiring adjuvant     chemotherapy will be excluded from this study. Subjects will be followed prospectively for 5     years for evaluation of toxicity, QOL and cosmesis. Disease status will be recorded.      Relevance: Completing adjuvant breast irradiation with a single out-patient treatment could     significantly improve QOL and convenience for patients choosing breast conserving therapy.     Confirming the technical feasibility and safety of PBSI is needed before progressing to     larger prospective evaluation of this novel adjuvant radiation therapy technique as a viable     treatment option for women in British Columbia.   "
159857|NCT01191151|"     The purpose of this study is to establish an international, web based clinical registry to     collect baseline characteristics of patients undergoing orthopaedic, sports medicine,     arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness     associated with the surgical procedures and nonoperative treatments.   "
159858|NCT01191138|"     Patients undergoing whipples pancreaticoduodenectomy tend to develop delayed gastric     emptying.      The study compares two types of anastamosis of stomach to jejunum (supracolic and infracolic)     and compares whether it influences the gastric emptying.      The clinical evidence of delayed gastric emptying is correlated with objective evidence of     liquid and solid emptying by radionuclide study.      The study also tries to evaluate whether pancreatic leak correlates with delayed gastric     emptying   "
159859|NCT01191125|"     To evaluate the effect of an experimental oral nutritional supplement containing AN777     compared to another oral nutritional supplement in a malnourished, elderly population.   "
159860|NCT01191112|"     The objective of this study is to determine the safe use and tolerance of a peptide-based     formula in children with gastrointestinal dysfunction and/or feeding intolerance.   "
159861|NCT01191099|"     A single-center cohort study to identify uni- and multivariate associations between marker     gene expression and clinico-pathological parameters for the detection of robust and novel     prognostic tools in prostate cancer   "
159862|NCT01191086|"     The purpose of this study is to examine the safety of USL255 as adjunctive therapy in     patients with refractory partial onset-seizures.   "
175740|NCT00142701|"     To test a practical, theory-based intervention to achieve long-term behavior change for     postmenopausal women with Type 2 diabetes at high risk for developing coronary heart disease     (CHD).   "
159865|NCT01191034|"     Human cancers express tumor antigens that can be targeted by cytolytic T lymphocytes (CTL).     These antigens consist of a small peptide, derived from endogenous proteins, that is     presented at the cancer cell's surface by an HLA class I molecule. Such antigenic peptides,     including MAGE-3.A1 and NA17.A2, have been tested in experimental therapeutic vaccines to     elicit CTL responses in cancer patients, mainly with metastatic melanoma. Up to now, only     rare tumor responses have been observed.      Tumor resistance to CTL killing is the most likely explanation for the poor effectiveness of     cancer vaccines. This resistance is probably acquired by the tumor during its development and     selected by its repetitive challenge with spontaneous anti-tumoral immune responses. The     precise molecular mechanisms of tumor resistance remain unknown. The observation that     tumor-infiltrating lymphocytes (TIL) purified from melanoma metastases can recognize and kill     autologous tumor cells in vitro, whilst they seem unable to control tumor growth in vivo,     suggests that this resistance is hosted by the tumor environment, rather than being the     result of a generalized immune suppression.      The investigators have developed a murine model of cutaneous graft rejection that mimics the     situation in melanoma. Female CBA mice do not reject syngeneic male skin grafts, even though     they mount a spontaneous CTL response against H-Y, a male specific minor histocompatibility     antigen, following grafting. The investigators have tested various experimental procedures     aimed at inducing effective graft rejection in these mice. This was obtained with a     combination of IFN-α, IL-2, GM-CSF, each administered separately under the skin graft,     associated with topical applications of imiquimod. All these agents are available as     registered drugs. Based on this murine model of cutaneous allograft rejection, the     investigators postulate that local immunomodulation with this combination can trigger an     effective tumor rejection process, and induce a more efficient and long-lasting anti-tumoral     immune response following peptide vaccination.   "
159866|NCT01191021|"     This trial investigates the relationship between concentrations of the anesthetic drug     propofol in exhaled breath, blood and drug effect in volunteers undergoing general     anesthesia. The main goal of this study is to develop a pharmacokinetic - and dynamic model     for propofol in exhaled breath.   "
159867|NCT01191008|"     The objective of this Investigation is to evaluate the safety and efficacy of long-term     treatment with Xalacom in medical practice. Also, occurrence of unknown and known adverse     drug reactions (ADRs) in subjects treated with Xalacom will be monitored during the survey     period, and whether an additional treatment outcome investigation and/or a post-marketing     clinical study is required in the future will be determined.   "
159879|NCT01190839|"     REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in     an experiment to see if it may be useful in preventing relapse of Crohn's disease after     surgical resection. This study will compare the effects (both good and bad) of REMICADE     (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active     ingredients.   "
159868|NCT01190995|"     Procedural pain in neonates is recently acknowledged entity and many studies on the use of     pharmacological as well as non pharmacological interventions for alleviation of this pain     have been done. Of these, sucrose with or without non nutritive sucking has been the most     widely studied and accepted form of pain relief. Its analgesic effect is thought to be     mediated by endogenous opioid pathways activated by sweet taste (orogustatory effect).      Although, guidelines based on systematic reviews and meta-analysis for pain management     recommend the use of sucrose solutions for pain relief during procedures, the use of repeated     doses of sucrose with preterm neonates requires further investigation.      Pain may have profound consequences for preterm neonates during a critical time of brain     development. Data derived from animal models suggests that repeated painful stimuli may     result in structural and functional reorganization of the nervous system and alteration in     future pain response. Early pain experience during this critical period in development are     thought to have immediate and long term consequences that could influence physiological,     behavioral and developmental outcomes. Early repetitive procedural pain related stress in     very preterm neonates is associated with poorer neurobehaviour in first 2 years of life.1     This study aims to assess the effect of repeated painful stimuli on short term neurobehaviour     of preterm infants and the efficacy of repeated doses of sucrose used for pain relief.   "
159869|NCT01190982|"     LEP-ETU is a novel, proprietary delivery system of paclitaxel developed by NeoPharm, Inc.     Paclitaxel (currently marketed as Taxol) is an anti-microtubular network agent and is active     in a broad spectrum of malignancies. Paclitaxel has poor solubility. In order to enhance the     solubility, this drug is formulated with polyoxyethylated castor oil, which leading to     infusion-related hypersensitivity reactions. The NeoPharm LEP-ETU is formulated with a     mixture of well characterized, synthetic phospholipids and cholesterol. This design     eliminates the need for the oil. The LEP-ETU formulation has improved safety profile that is     necessary for administering higher doses than would commonly be used with Taxol. The clinical     evidence obtained from the NeoPharm Phase I study shows LEP-ETU is better tolerated than     Taxol, as indicated by a higher maximum-tolerated dose (MTD). The current Phase II study is     designed to accomplish the following objectives:        1. Assess the Overall Response Rate (ORR) of patients with metastatic breast cancer after          administered over 90 minutes at the dose of 275 mg/m2 LEP-ETU        2. To evaluate the Progression-Free Survival (PFS)        3. To evaluate the safety of LEP-ETU at 275 mg/m2 level, in particular peripheral          neuropathy        4. To evaluate the Overall Survival (OS)   "
159870|NCT01190969|"     The purpose of this study is to determine whether short-term use of oral nutritional     supplements as part of the diet improves nutritional and functional status of     post-hospitalization malnourished elderly.   "
159871|NCT01190943|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers     related to cancer. DNA analysis of tumor tissue may also help doctors predict how well     patients will respond to treatment.      PURPOSE: This research study is studying DNA biomarkers in tissue samples from patients with     osteosarcoma.   "
159872|NCT01190930|"     This partially randomized phase III trial studies different combinations of risk-adapted     chemotherapy regimens and their side effects and comparing how well they work in treating     younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage     lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized).     Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Giving more than one drug (combination chemotherapy), giving the drugs in different doses,     and giving the drugs in different combinations may kill more cancer cells.   "
159873|NCT01190917|"     The purpose of this study is to compare two different treatment approaches to social skills     groups for high-functioning children with Autism Spectrum Disorder (ASD). This project will     examine changes in both behavior and the brain following treatment.   "
159888|NCT01190722|"     The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a     better patients assessed overall satisfaction when used for pain management after elective     hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs     (NSAIDs).   "
159889|NCT01190709|"     The purpose of this study is to determine which surgical approach is better for treatment of     tibial shaft fracture   "
159874|NCT01190904|"     The purpose of this study is to find out if androgen deficiency (low levels of testosterone,     a male hormone produced by the sex glands) and erectile dysfunction (sexual dysfunction) will     predict over time the development of a heart attack, stroke, or death in men with Diabetes     Mellitus who have angiographically proven coronary artery disease (CAD) (≥50%) with or     without percutaneous coronary intervention (PCI). A substudy aims to show the different     factors and processes that may show a relationship between sexual function and levels of     androgen in the body to heart disease.   "
159875|NCT01190891|"     The purpose of this study is to evaluate and compare the short and long-term effectiveness of     two common interventions, manual physical therapy versus corticosteroid injection, for the     treatment of shoulder impingement syndrome.   "
159876|NCT01190878|"     The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in     topical administration of differing dosing regimens of ISV-303 compared to vehicle and     Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.   "
159877|NCT01190865|"     The goal for this study is to examine the persistence of growth     arrested,allogeneic,male-donor keratinocytes and fibroblasts when applied as product     HP802-247 to the surface of acute excisional wounds in health female volunteers, as measured     using Y-STR for detection of Y-chromosome.   "
159878|NCT01190852|"     The primary objective is to assess the effect of fluticasone propionate (FLU) on the relative     bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU     combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE     alone; REF).      The secondary objectives are to compare the relative bioavailability (AUC0-∞) of AZE when     administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product     Astelin® Nasal Spray (COMP); To compare the effects of FLU on other pharmacokinetic     parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½); To assess adverse events.   "
159882|NCT01190800|"     The purpose of this study is to assess decision-making capacity in persons with Alzheimer's     disease. First, our goal is to validate four French capacity assessment tools for persons     with Alzheimer's Disease : a French version of the Competency Assessment Tool for Consent to     Treatment and of the Competency Assessment Tool for Voting, two questionnaires assessing the     capacity to appoint a proxy either to consent to treatment or to vote. Second, once     validated, we plan these questionnaires to study decision-making abilities and their     determinants in persons with Alzheimer's disease and control subjects.   "
159883|NCT01190787|"     This protocol is a single-arm, three-cohort, phase II multicenter study designed to assess     the safety and the efficacy of three all-oral combinations: Velcade with continuous low-dose     melphalan and prednisone (VMP) or with continuous low-dose cyclophosphamide and prednisone     (VCP) or Velcade with low-dose prednisone could be effective and well tolerated (VP).   "
159884|NCT01190774|"     Dental anxiety is a significant barrier to the acceptance of regular dental care, and has     many negative consequences. A study by Dailey et al. (2002) found that providing the dentist     with information of the high level of a patient's dental anxiety prior to treatment using the     Modified Dental Anxiety Scale (MDAS, Humphris et al., 1995), lead to a significant reduction     in state anxiety from pre- to post- dental consultation compared to a control group. The     current study aimed to replicate the study by Dailey et al. (2002), and to further explore     whether the reduction in state anxiety associated with the MDAS could be explained by a     change in dentist behaviour on receiving it, or a change in patient expectancy about the     treatment session, or both.      The design was a randomised control trial involving three groups, which aimed to manipulate     possible changes in dentist behaviour and patient expectancy. In Group 1, the MDAS was left     at reception, as expected by the patient. In Group 2, the dentist received the MDAS, although     the patient did not expect this. In Group 3 the dentist received the MDAS and the patient did     expect this. The sample (N=182) was taken from two dental access centres, and included     participants obtaining a score of 19 or above, or 5 on any one item of the MDAS. Pre- and     post-dental consultation measures of state anxiety were taken using the six-item short-form     of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI-S, Marteau &     Bekker, 1992).   "
159885|NCT01190761|"     The objective of this study was to compare the rate and extent of absorption of Purepac, a     subsidiary of Alpharma Inc., U.S.A., galantamine and Janssen Pharmaceutica Products, L.P.,     U.S.A. (Reminyl),galantamine, administered as a 1 x 4 mg tablet, under fed conditions.   "
159886|NCT01190748|"     The objective of this study was to compare the rate and extent of absorption of Purepac, a     subsidiary of Alpharma Inc., U.S.A., galantamine and Janssen Pharmaceutica Products, L.P.,     U.S.A. (Reminyl),galantamine, administered as a 1 x 4 mg tablet, under fasting conditions.   "
159887|NCT01190735|"     Numerous epidemiological studies have linked lifelong use of caffeine to a lower risk of     Parkinson's disease (PD) - prospective studies have estimated that non-coffee drinkers have     an approximately 1.7-2.5 fold increased risk of developing PD compared to coffee drinkers.     This is an extremely important finding which deserves further more in depth investigations.      The exact pathophysiological mechanism remains elusive, but multiple hypotheses do exist:     Caffeine antagonizes adenosine receptors directly yielding an improvement on motor systems     and even on Levodopa serum concentrations (when on therapy). An additional explanation is     that adenosine antagonism has neuroprotective properties by acting locally on basal ganglia     circuits and the substantia nigra.      The current study aims to identify the optimal caffeine dose with maximal motor benefit and     the least amount of undesirable adverse effects.   "
159890|NCT01190696|"     The purpose of this study is to determine which method is better for treatment of femoral     fracture in children in outcomes.   "
159891|NCT01190683|"     Vitamin D deficiency is widely prevalent in India. Serum 25(OH)D levels are <20 ng /ml in up     to 90% of them. Recently, in a randomized control trial, investigators have shown that dual     cholecalciferol and calcium supplementation lead to significant improvement in hand grip     strength and distance covered during six minutes walk test. Present study is being taken to     further understand the functional significance of 25(OH)D in terms of its effect on Skeletal     muscle strength including surface electromyography (EMG) in a larger cohort involving     approximately 200 subjects. The impact of calcium and vitamin D supplementation would be     assessed by supplementing them alone and in combination. Besides, the investigators would     also assess impact of above supplementation on Th1/Th2 cytokines expression in the peripheral     mononuclear cells.   "
159892|NCT01190670|"     The objective of the study is to characterize the effect of multiple doses of ASP015K on the     pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.   "
159893|NCT01190657|"     This is a self-controlled, open, multiple-center clinical trial.   "
159894|NCT01190644|"     What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by     dosing with Sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has     determined that all of these goals could be obtained by an intense 10 patient, Sotatercept     (ACE-011) pharmacodynamic study, completed by two well known experts in the red cell     production field.   "
159895|NCT01190631|"     The purpose of this study was to evaluate total residual spherical aberration (TSA) post-IOL     implantation, and to determine if an association exists between TSA, postoperative high order     aberrations (HOA), and functional vision following IOL implantation in patients grouped by     pre-operative corneal spherical aberration (CSA).   "
159896|NCT01190618|"     The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair     with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair     with Prolift. .   "
159897|NCT01190605|"     Women with HIV infection in Mississippi who are pregnant or who have had their baby in the     past year can agree to fill out a questionnaire about what helps or hurts return to care for     HIV infection after having a baby. The combined results should show the most common things     that keep women from getting care for HIV infection after having a baby. This will help     design another study in order to help more women get into care for HIV infection after having     a baby.   "
159925|NCT01190241|"     The purpose of this study is to select targeted treatment based on ex vivo kinase activity     inhibition profiles to targeted agents of tumor tissue from patients with advanced cancer for     whom no standard treatment is available.   "
159898|NCT01190592|"     The investigators primary objective is to evaluate the effect of a 6 month (3 days/wk)     supervised, progressive RT program with increased daily milk intake in untrained adolescents     on measures of body composition and cardiovascular risk factors. The investigators     hypothesize that milk supplementation will produce significantly greater favorable changes in     all body composition measures compared with RT + carbohydrate and control.   "
159899|NCT01190579|"     The trial will investigate the accuracy of Dual Source CT coronary angiography to detect     coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an     intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will     be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT     will allow the detection of vessels with at least one coronary artery stenosis with a     sensitivity of more than 90%.   "
159900|NCT01190566|"     The purpose of this study is:      To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging     in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced     breast cancer patients.      To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI,     dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response     to neoadjuvant chemotherapy of locally advanced breast cancer patients.      To compare the performances of dynamic contrast-enhanced MRI using parametric response map     analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early     prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer     patients   "
159901|NCT01190553|"     This is a pilot study for Maintenance Intravenous Treatment with AMANTADINE in patient with     PARKINSON'S Disease who are not well balanced with medical treatment.   "
159902|NCT01190540|"     This evaluation aim is to investigate a cost-effective way to build capacity for the care and     prevention of infectious diseases among mid-level practitioners (MLP) in sub-Saharan Africa.     Classroom based training continues to be the dominant form of training, despite evidence that     suggests that on-site support (OSS) is more beneficial. Definitive evidence that on-site     support is the most effective way to deliver the required outputs and related outcomes is     still lacking. IDCAP will provide two interventions that integrate training in TB, HIV/AIDS     and malaria as well as other infectious diseases, and the effects will be studied: 1)     Integrated Management of Infectious Disease (IMID) training program for individual MLP, and     2) On-site support (OSS) for team of health professionals. This study employs a mixed design     with pre/post and cluster randomized trial components. Interventions are at the level of the     individual participant for IMID and at the level of the site (health facility) for OSS. All     participants attend a 3-week course, followed by two 1-week booster courses over a six month     period. After the 3-week course, a randomized arm of half the sampled facilities also     received OSS every month for 9 months and bi-monthly for 6 additional months.   "
159918|NCT01190332|"     One of the new methods for management of common bile duct stones is intraoperative endoscopic     sphincterotomy. It can be performed by many techniques. In the study the investigators     compare two methods to find out the best technique for intraoperative endoscopic     sphincterotomy.   "
159919|NCT01190319|"     The specific aim of the study is to determine whether a freeze dried powder provided by the     California Strawberries Commission, can reduce blood pressure in patients with     pre-hypertension. The powder is prepared by the California Strawberry Commission (CSC).   "
159920|NCT01190306|"     The purpose of this research study is to test the safety, tolerability, and effectiveness of     corneal collagen cross-linking (CXL), when used to treat keratoconus.   "
159921|NCT01190293|"     The purpose of the study aims is to help determine whether it is safe to change directly from     efavirenz to maraviroc in patients who are stable on an efavirenz-containing regimen. The     pharmacokinetics (drug levels) of efavirenz and maraviroc when efavirenz is stopped and     maraviroc is started will be assessed.      Both the study patients and the study team will know which treatment is being taken at all     times in the study.   "
159903|NCT01190527|"     Successful treatment of non-small cell lung cancer with radiation therapy requires that the     physicians determine exactly where the tumor is in your body, and protect your normal tissue.     This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission     Tomography (FDG-PET) before treatment, and then again during treatment to see if the     procedure helps predict how well the treatment works for your cancer and how well your lung     functions during treatment. FDG-PET is a modern technology that uses small amounts of a     radioactive glucose (FDG) to make images of your whole body and areas of active cancer. A     Computerized Tomography (CT) will also be performed along with both of these procedures to     help the researchers see clearly where your cancer or your healthy lung is located. The study     will help the investigator determine whether an adaptive plan that is applied based on repeat     PET-CT imaging during the course of radiation therapy (during RT), can show if there is an     improvement in treatment outcome compared to those treated with standard radiation therapy.     This adaptive plan may allow your doctor to escalate the dose per treatment and the total     dose of your treatment based on the risk of damage to your healthy lung tissue. While     increasing the radiation dose, but limiting the toxicity to normal lung tissue, the     researchers hope to improve your tumor control.   "
159904|NCT01190514|"     To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of     DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.      To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after     administration of 50 mg SR formulation of DVS.   "
159905|NCT01190501|"     Our main objective is to assess whether aortic stiffness is a predictor of blood pressure     response after surgery in patients with an aldosterone producing adenoma or a unilateral     adrenal hyperplasia.   "
159953|NCT01189877|"     The purpose of this study is to see if the cells in rectal cancer are oxygen-starved, or     hypoxic. We know that as cancers grow bigger, parts of them are cut off from the oxygen     supply and they become hypoxic, basically, lacking oxygen. Research has shown that cells that     are oxygen-starved respond differently to treatment such as chemotherapy and radiation when     compared to cells that are oxygen rich.   "
160111|NCT01187810|"     The purposee of this study is to determine the safety and dosing of Fenretinide when given     continuously for 5 days, every 3 weeks, in pediatric patients with recurrent and/or resistant     acute lymphoblastic leukemia (ALL), acute myelogenous leukemia (AML), and non-Hodgkin's     lymphoma (NHL).   "
159906|NCT01190488|"     The investigators propose an evaluation of an end of life patient decision aid (EOL-PtDA)     developed by the Foundation for Informed Medical Decision Making using the RE-AIM (Reach     Effectiveness, Adoption, Implementation, and Maintenance) framework. To evaluate the Reach     and Effectiveness, the investigators propose a pilot randomized clinical trial of the     EOL-PtDA among patients on the inpatient palliative care service at University Hospital in     Colorado. To evaluate barriers and facilitators of Adoption, Implementation, and Maintenance     of the EOL-PtDA, we propose focus groups of non-palliative care physicians as we perceive     these physicians to be the largest barrier to ultimate adoption of the EOL-PtDA. Additionally     we propose a focus group of the palliative care physicians who participated in the     implementation of this decision guide study to evaluate the feasibility of conducting a     randomized control trial within a pall. care service and to evaluate the acceptability of     this decision aid as it was implemented. The investigators also propose to conduct focus     groups of normal, healthy clinic patients to determine the acceptability among that     population. The End-of-Life decision aid is different from other decision aids. From the     vantage point of decision quality, a major difference is that its primary focus is on helping     patients clarify their values rather than gain knowledge. The results from this study will     provide critical preliminary data to inform a randomized clinical trial and/or widespread     implementation of the EOL-PtDA.      Specific Aims/Research question(s):Aim 1: To determine the Reach and Effectiveness of an     end-of-life patient decision aid by conducting a pilot randomized clinical trial in an     inpatient palliative care service. Aim 2: To determine physicians' attitudes towards the     end-of-life patient decision aid and to gain insights into potential barriers and     facilitators to Adoption, Implementation, and Maintenance by conducting a qualitative study     of non-palliative care, and separately, palliative care physicians. Aim 3: To determine     healthy clinic patients' attitudes towards the end-of-life patient decision aid and to gain     insight into its Reach and Effectiveness.   "
159907|NCT01190475|"     This study will assess the safety and tolerability of BGS649 in women with moderate to severe     endometriosis.   "
159908|NCT01190462|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Simvastatin may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Simvastatin may help     cetuximab work better by making tumor cells more sensitive to cetuximab. Giving cetuximab     together with simvastatin may kill more tumor cells.      PURPOSE: This phase II trial is studying giving cetuximab together with simvastatin in     treating patients with advanced or metastatic colorectal cancer.   "
159909|NCT01190449|"     RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them.      PURPOSE: This randomized phase II trial is studying ofatumumab to see how well it works in     treating patients with previously untreated stage II, stage III, or stage IV follicular     non-Hodgkin lymphoma.   "
159910|NCT01190436|"     The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm     study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day     bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on     therapy.   "
159911|NCT01190423|"     Temple University is conducting a National Institute of Health funded research study designed     to develop and refine a family-based treatment manual for young adults with Anorexia Nervosa     as well as assess the feasibility of this out-patient psychotherapy.   "
159912|NCT01190410|"     The purpose of this study is to evaluate the long-term safety and tolerability of     certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely     active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK),     and immunogenicity of CZP treatment in children and adolescents with moderately to severely     active Crohn's disease.   "
159913|NCT01190397|"     The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in     the eyelids      Phase I, prospective, comparative study, investigator masked , monocentric      Objectives are To assess and compare the warming and moisture of Blephasteam® device versus     the warming and moisture of warm and moist compresses.      To assess and compare safety on the ocular surface after 10 minutes of Blephasteam®     application versus after 10 minutes of warm and moist compresses application   "
159914|NCT01190384|"     Determine whether eating beans with a high fat meal will reduce the inflammatory response in     people with the metabolic syndrome and increase feelings of satiety.   "
159915|NCT01190371|"     The purpose of this study is to determine whether P. falciparum infections in Kilifi District     have developed tolerance to the artemisinin class of drugs.   "
159916|NCT01190358|"     The purpose of this study is to determine whether taking grape seed extract prior to eating a     high fat meal will reduce the inflammatory response in people with the metabolic syndrome.   "
159917|NCT01190345|"     The purpose of this study is to evaluate anti-cancer stem cell (CSC) activity (measured by     the amount of Aldehyde dehydrogenase 1/ALDH1+ cells before and after treatment) of     pre-operative bevacizumab in combination with conventional chemotherapy in breast cancer     receiving neo-adjuvant treatment, compared to a control arm receiving chemotherapy alone.   "
160975|NCT00000548|"     To test the hypothesis that low-dose inhaled nitric oxide administered to preterm infants who     continue to require mechanical ventilation at 14 days of age will reduce the incidence of     chronic lung disease.   "
159922|NCT01190280|"     The aim of the study is to identify patients with gallstone disease that should be operated     and those that may potentially be observed. This selection was based on symptoms and clinical     presentation. The consequences that may arise for the patient if observation is chosen     compared with outcome after cholecystectomy has been markers of outcome.   "
159923|NCT01190267|"     This study is designed to evaluate whether asenapine, which is approved by the United States     Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is     generally safe and well tolerated in adolescents with schizophrenia. This is an extension of     base study P05896 (NCT01190254), which means participants must have completed participation     in the 8-week base study in order to qualify for this extension study P05897. Participants in     this extension study will receive open-label asenapine for 26 weeks. Throughout the study,     observations will be made on each participant at various times to assess the long-term     safety, tolerability and efficacy of the study treatment.   "
159924|NCT01190254|"     This study is designed to evaluate whether asenapine, which is approved by the United States     Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also     effective in adolescents with schizophrenia. Participants who qualify for the study will be     randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice daily     [BID]) or placebo for 8 weeks. Throughout the study, observations will be made on each     participant at various times to assess the efficacy and safety of the study treatment. The     primary objective of the trial is to demonstrate significant superiority of at least one     asenapine dose to placebo, as measured by the change from baseline of the Positive and     Negative Syndrome Scale (PANSS) total score at Day 56.   "
159926|NCT01190228|"     The aim of the study is to investigate the memory immune response and the yearly persistence     of the immunity against Japanese Encephalitis (JE) after vaccination with a new Japanese     Encephalitis Chimeric Virus (JE-CV) in participants previously vaccinated with JE-CV.      Objectives:        -  To describe JE immune status before, and after a JE-CV booster dose in subjects          previously vaccinated with JE-CV        -  To describe the immune status before, and immune response following JE-CV vaccination in          JE-naïve control subjects.        -  To describe the safety (in terms of solicited and unsolicited adverse events) of a          single dose of JE-CV up to 6 months after the last vaccination.        -  To describe all related serious adverse events (SAEs) and related deaths from 6 months          to 5 years after vaccination in JE-CV-primed subjects.   "
159927|NCT01190215|"     This study is designed to assess the immunogenicity, reactogenicity and safety following     vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been     vaccinated with one dose of PandemrixTM at the age of 10-17 years.   "
159928|NCT01190202|"     The aim of this epidemiology study is to characterize in a standardized way malaria     transmission intensity at the clinical trial centers participating in study 110021     (NCT00866619).   "
159929|NCT01190189|"     This extension study is designed to assess the safety of GSK Biological's human     papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study     NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV     vaccine is not indicated for the subject's age group (26 years and older). This study is thus     conducted to enable all women who received the control placebo in the primary NCT00294047     study to receive the GSK580299 vaccine.   "
159930|NCT01190176|"     This study is intended to provide up to a maximum of four years of annual oncogenic human     papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study     subjects who displayed normal cervical cytology but tested positive for oncogenic HPV     infection at their concluding NCT00294047 study visit.      Women who were pregnant at their concluding NCT00294047 study visit may also be included in     this study, as no cervical sample could be collected at that visit.      The objectives and outcome measures of the primary phase (NCT00294047) are presented in a     separate protocol posting.   "
159931|NCT01190163|"     This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in     unfavorable cervix pregnant women with 38 or more weeks of gestational age.   "
159932|NCT01190150|"     This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic     acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female     subjects ages 12-16 years with heavy menstrual bleeding.   "
159933|NCT01190137|"     There are two different types of vitamin D - vitamin D3 (animal source) and vitamin D2 (plant     source). Almost all the usual vitamin D preparations for infants available in Canadian     pharmacies contain vitamin D3 which may not be suitable for families who avoid animal     products for social or religious reasons. The purpose of this study is to learn more about     the two forms of vitamin D and if blood levels of vitamin D are similar in infants after     taking them. Forty-eight breastfed infants will be randomly assigned to 400 IU of either     vitamin D2 or D3 supplement for 3 months starting at 1 month of age. The difference in blood     vitamin D levels, after 3 months of supplementation, between the two groups will help     determine if the two supplements are equal.   "
159934|NCT01190124|"     The purpose of this study is to evaluate the efficacy of raltegravir with optimized     background therapy (OBT) in multiple-experienced HIV infected patients, measured by the     proportion of patients with undetectable viral load and the mean increase of CD4 cells count     at week 24 and 48.      It is also intended to evaluate:        -  viral load suppression and the mean increase of CD4 cells count at week 24 and 48 in          patients who needed to change antiretroviral (ARV) therapy due to inacceptable toxicity,          as determined by the investigator, including patients who needed to replace T20.        -  efficacy of raltegravir with OBT in HIV-2 infected patients that were included in this          cohort, measured by the percentage of patients with undetectable viral load and the mean          change of CD4 cells count at week 24 and 48.      Study hypotheses:        -  Raltegravir with OBT is effective in achieving and maintaining a long term virologic          suppression along with a significant increase on CD4 cells count in both HIV-1 and HIV-2          infected patients.        -  Patients who replaced T20 by raltegravir, due to intolerance, are able to maintain long          term virologic suppression.   "
159936|NCT01190098|"     Sleepiness and fatigue are the most common complaints of people with epilepsy and can have a     negative impact on quality of life. Though unproven, these problems are often blamed on     anti-seizure medications. The purpose of this study is to investigate the impact of the     anti-seizure medication Lacosamide (Vimpat®) on sleep and wakefulness in adults with focal     (partial onset) seizures.      Focal epilepsy, also called partial epilepsy, is a disorder characterized by seizures arising     from a localized network of neurons in the brain. Focal seizures usually begin a sensation or     involuntary movement of a part of the body, an unusual feeling, or a disturbance in hearing,     smell, vision, or consciousness. The study is open to adults 18 and older with focal     seizures.      Participation involves a physical exam, sleep testing at the Sleep Center, blood tests,     completion of study questionnaires/diaries, and a random assignment to either take the study     drug or placebo (often called a look alike or sugar pill) for 5 to 8 weeks. There are 5     study visits. Participants will receive compensation for time spent in the study.      If you would like more information on this study please contact the Cleveland Clinic Sleep     Center:      Dr. Nancy Foldvary-Schaefer: 216-445-2990 Monica Bruton: 216-444-6718   "
159954|NCT01189864|"     The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced     cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and     biochemical stability of the cornea by inducing additional cross-links within or between     collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study     is to generate data for presentation at medical meetings and for peer-review publication. The     data generated by this study will not be submitted to the FDA to support commercialization of     these riboflavin drops.   "
159955|NCT01189851|"     Up to 200 patients with biopsy proven early stage breast cancer selecting Wide Local Excision     (WLE) will undergo mammography, ultrasound (of affected breast and ipsilateral axilla) and     contrast enhanced-magnetic resonance imaging (CE-MRI) of the affected breast to evaluate the     extent of disease.   "
159937|NCT01190085|"     Only a few medications are approved for the treatment of alcohol dependence and there exists     a substantial need for discovering ways to provide more effective treatments. Accordingly,     identifying new potential neuropharmacological targets in the treatment of alcohol dependence     represents a high priority in public health. Ghrelin is a 28-amino acid peptide acting as the     endogenous ligand for the growth hormone secretagogue receptor (GHS-R). Ghrelin was first     isolated from the stomach, but a central hypothalamic production of ghrelin has also been     demonstrated. Ghrelin plays a key role in the regulation of appetite. Consistent with the     common neurobiological substrates for control of food and alcohol consumption, preclinical     investigations suggest that ghrelin plays a role in the neurobiology of alcohol dependence,     thus representing a new potential neuropharmacology target. In keeping with the preclinical     studies, human investigations showed that alcohol consumption affects blood ghrelin levels     and that blood ghrelin levels significantly and positively correlate with craving     measurements in alcohol-dependent individuals. The effects of exogenous ghrelin injected     intravenous (i.v.) in alcohol-dependent individuals, however, have never been investigated.     The current project proposes a randomized double-blind placebo-controlled 3-group     between-subject laboratory study aimed at investigating the effects of exogenous ghrelin i.v.     on non-treatment seeking alcohol-dependent subjects in terms of urges to drink, attention to     cues and related psychophysiological measures. This project has the goals to: i) conduct an     alcohol laboratory study testing the role of ghrelin i.v., therefore demonstrating the     feasibility of such a study and the safety of ghrelin i.v. when administered to     alcohol-dependent individuals; and ii) explore the effects of ghrelin i.v. on alcohol craving     assessed under controlled conditions, such as a cue-reactivity (CR) experiment.      This study will address whether alcohol craving is affected when ghrelin levels are modified     acutely via a ghrelin i.v. injection. Given the crucial need to expand our understanding of     the underlying neurobiology of alcoholism, this study potentially will lead to identify new     targets for the development of pharmacological treatments that may improve interventions for     alcohol dependent individuals.   "
159938|NCT01190072|"     The purpose of the study is to follow the management of blood lipids in patients with planned     percutaneous coronary intervention (widening of coronary vessels) in a period from 6 to 10     weeks after the intervention.   "
159939|NCT01190059|"     The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for     donor lungs that fail to meet standard acceptability criteria. This advanced assessment might     lead to increased utilization rates of donor lungs and improved outcomes after lung     transplantation.   "
159940|NCT01190046|"     The purpose of this study is to define the effects of chronic disuse on skeletal muscle     structure and function in elderly individuals at the cellular and molecular level by     examining elderly characterized by chronic muscle disuse (patients with knee osteoarthritis)     and healthy elderly no evidence of knee osteoarthritis and normal physical activity levels.   "
159941|NCT01190033|"     This is a prospective, randomized, double-blind, placebo-controlled study. In an initial     phase, 100 patients with chronic low back pain will be included in this study. The patients     will be recruited through magazines and newspapers to take part in a screening for treatment     of low back pain. This screening will involve the evaluation of data such as history and     physical examination to classify the patient in the group of nonspecific low back pain,     excluding patients with neurological alterations and the so-called Red-Flags.      Procedures After the initial screening the patients will undergo diagnostic blocks of the     medial branch of lumbar vertebrae L2, L3, L4 , L5 and of the first sacral vertebra (S1) with     lidocaine and control with distilled water. The patients that present more than 50% of pain     improvement, evaluated by the Likert scale after 30 minutes will form the study group, while     the patients that do not present pain improvement with lidocaine or that present pain     improvement with distilled water will be excluded.      The medial branch block consists of the insertion of a 90mm, 25-gauge needle through the skin     with radioscopic control up to the medial branch topography. Infusion of 1ml of 2% lidocaine     should be performed in each medial branch of the abovementioned vertebrae. Control is     executed in the same manner yet with infusion of 1ml of distilled water.      Through the use of the diagnostic block we will have 40 patients selected for the second     phase of the study. Once defined the study group should be evaluated before the procedure     through the Oswestry, Roland Morris, SF-36 and VAS questionnaires.      In the second phase of the study the patients will be randomized. The random division into     two groups will be performed through a computerized program of random numbers. The     randomization result will be kept in matt sealed envelopes to guarantee secrecy of the     allocation. The neurolysis procedure will be carried out in the first group, consisting of 20     patients, and the placebo or sham procedure with the second group, also with 20 patients.      The neurolysis procedure will be carried out under sterile conditions, with the patient lying     prone and with the neurotome insertion sites anesthetized with 2ml of 1% lidocaine. The     neurotome (Smith & Nephew - RF) will be used for the procedure. The neurotome is a     radiofrequency apparatus mounted on a 10cm electrode type 22 needle with a 5mm exposure tip.     The neurotome should be introduced percutaneously in a manner similar to that adopted in the     medial branch block through radioscopic control. The temperature of the electrode after its     placement in the correct position is then raised to 80 °C for 90 seconds. Two neurotomies     should be performed for each facet, one proximally and the other distally, due to double     innervation of each facet. In the patients of the placebo group the procedure will be the     same only the temperature of the neurotome will not be raised. This will be performed in a     blind manner, as before starting the procedure, the surgeon will show the assistant who turns     the device on or not the envelope containing the patient's group (placebo or neurotomy), yet     the surgeon will not be informed whether the device has been turned on or not, having to     perform the procedure in the same manner in both groups.      The patients will then be reevaluated in the first month, 3 months after, 6 months after and     12 months after the procedure. The assessors will not be informed of the group to which the     patient belongs, and the same scales performed in the preoperative period will be used here.   "
159942|NCT01190020|"     Lubiprostone, a chloride channel activator, has been shown to improve symptoms of chronic     constipation, largely by enhancing chloride-rich intestinal fluid secretion. Whether     Lubiprostone has effects on colonic methanogenesis is not known. The investigators     hypothesize that the effects of Lubiprostone may in part be due to its effects on altering     colonic flora, particularly methanogenic flora.      By altering the colonic stasis of stool and through more efficient clearance of digestive     residue, the investigators anticipate that Lubiprostone may either inhibit or promote better     excretion of methanogenic flora, and thereby decrease the gut load of methane producing     bacteria. In turn, this may lead to enhanced colonic smooth muscle contraction and an     increased rate of spontaneous bowel movements and reduction of constipation symptoms.      The aim is to investigate the effects of Lubiprostone on intestinal methane production and     bowel symptoms in patients with chronic constipation, by performing a randomized, double     blind, placebo controlled study.   "
159943|NCT01190007|"     The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5     mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in     Japanese patients with both of hypertension and hypercholesterolemia, or with both angina     pectoris and hypercholesterolemia.   "
159944|NCT01189994|"     Fibromyalgia is a medical condition characterized by musculoskeletal pain, fatigue, sleep     disturbances and depression. It affects population at a socioeconomically active age and     represents a burden for the patients and the health care system due to its personal and     functional implications. At this moment, there is no completely effective treatment for     fibromyalgia, and acupuncture has been a promising alternative. This trial aims to evaluate     if addition of acupuncture to standard care represents an improvement in comparison with     standard care only. Thus, patients enrolled in this trial will be randomly allocated into one     of two groups: group A, who besides standard treatment will receive 12 sessions of     acupuncture; and group B, who will receive standard care with monthly orientation sessions     for the same period. Patients will be evaluated at baseline, after completion of acupuncture     treatment or orientation, and after an additional 12-week follow up. Evaluation will be based     on diaries of pain and medication, and standard scales of pain, quality of life and     disability.   "
159951|NCT01189903|"     1. Primary Endpoints             -  Biomarker data suggestive of regorafenib-mediated inhibition of the RAS-RAF-               MEK-ERK signal transduction pathway,of various tyrosine kinase receptors and/or of               angiogenesis.             -  Evaluation of potential relationships between biomarker data and clinical activity.             -  Evaluation of a novel biomarker technology (Prometheus COPIA platform)        2. Secondary Endpoints             -  Biomarker data suggestive of regorafenib-mediated effects on circulating rare               cells.             -  Comparison of tumor genetic profiles obtained using DNA isolated from plasma, tumor               biopsies and circulating tumor cells.             -  Patient safety data             -  Pharmacokinetics of regorafenib             -  Changes in tumor metabolic activity as measured by PET CT scan (optional)   "
159952|NCT01189890|"     The primary objectives of this study are to determine if sitagliptin treatment is not     inferior to that of glimepiride as measured by the change in baseline hemoglobin A1C (HbA1C)     after 30 weeks of treatment, and if sitagliptin treatment results in a lower incidence of     symptomatic hypoglycemia compared to that of glimepiride. The study will also evaluate if     sitagliptin treatment, compared to glimepiride results in improvements in fasting plasma     glucose (FPG) levels, and plasma lipid levels after 30 weeks of treatment. Participants will     be randomized to either sitagliptin or glimepiride treatment after eligibility for study     participation is determined during screening and washout study phases. Participants and study     staff will not know to which treatment group they have been randomized (double-blind design).     The duration of study participation will be up to 40 weeks (with 9 clinic visits). This will     include a screening phase (Visit 1 to Visit 2) of 2 weeks maximum; a 6-week (Visits 2 to 3)     oral antihyperglycemic agent (AHA) wash-out phase (for those who have been taking a AHA prior     to the study); a placebo run-in phase (Visits 3 to 4), followed by up to 30 weeks of     treatment with study medication.   "
160112|NCT01187797|"     The purpose of this study is to evaluate the effects of a short-term emotional stimulation on     the mood of healthy persons.   "
159945|NCT01189981|"     All over the world 0.8 % of all live children are born with a Congenital Heart Disease (CHD)     due to genetic end environmental causes. Advanced treatment and care has enhanced survival     substantially, and adults with CHD are a growing population requiring continuous monitoring     and care. Presently 25% of young adults acquire complicating Cardio Vascular Diseases (CVD)     in young adulthood amongst other co-morbidities.      It is known that adolescents with CHD are not as physical fit (PF) as their cardiac     capability allows, most likely for reasons concerning safety, ability plus inactive everyday     life. However, in 2006 The European Society of Cardiology states, that regular exercise at     recommended levels can be performed and should be encouraged in all patients with CHD.     Training programmes in hospitals have an effect on PF and Quality of Life (QoL) for the few,     as most adolescents' find it impossible to fit into everyday life.      It is the investigators hypothesis that an eHealth intervention, to facilitate intensive     exercise in the patients' neighbourhood environs, may improve physical fitness more     efficiently than standard lifestyle education.      The purpose of the study is to create evidence to recommend an efficient, fun and safe     cardiac rehabilitation programme to adolescents with CHD.      Primary outcome measure      Cardiopulmonary exercise capacity: Online V02 max bicycle test      Secondary outcome measure      Level of physical exercise: Actigraph and Questionnaire      Tertiary outcome measure      Quality of Life: PedsQl      Prevail is a national prospective, randomized clinical trial including 216 adolescents aged     13-16 years, who have had cardiac surgery in childhood owing to complex CHD. The patients     included are all recommended to be as physical active as their healthy peers and pursue the     principle guideline from The National Board of Health: All children and young people must be     physically active for at least 60 minutes a day, preferably longer. Patients with mental     retardation and FEV1 at baseline < 80% of predicted are excluded.      The risk of participating in the purposed trial is not regarded as higher than everyday daily     living.      Results will be interpreted according to affiliation to health related fitness clusters.   "
159946|NCT01189968|"     The purpose of this study is to test the safety and determine the optimal dose of a new drug,     demcizumab (OMP-21M18), when given in combination with carboplatin and pemetrexed, a standard     drug treatment regimen for non-squamous non-small cell lung cancer (NSCLC). Participants must     not have received prior chemotherapy for their NSCLC. Demcizumab is a humanized monoclonal     antibody (a protein made in the laboratory) developed to target cancer stem cells. The way     the body handles demcizumab will also be investigated.      Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain.     Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your     eligibility to take part in this study, and then if enrolled in the study you will receive     intravenous (in the vein) infusions of the demcizumab, carboplatin, and pemetrexed     administered on the same day, every 21 days for 4 cycles, or until it has been shown that     your cancer has progressed. If your physician decides to delay treatment with one of the     agents due to side effects, the other agents may still be administered as scheduled. After 4     cycles, if you have stable or improved disease, you will continue to receive pemetrexed once     every 21 days as maintenance therapy. You will undergo assessments every 8 weeks to determine     the status of your disease.   "
159947|NCT01189955|"     Consecutive patients treated for thyroid enlargement at our institution were evaluated for     inclusion. Participants were randomly allocated to receive total thyroidectomy using harmonic     scalpel HS or using ligature conventional thyroidectomy CT Follow-up visits were after 1     week, 1 month, and 6 months, Study variables included operative time, length of incision,     operative bleeding, postoperative drainage, hospital stay and complication.      one hundred and thirty patients with thyroid enlargement were randomized and completed the     study.   "
159948|NCT01189942|"     The purpose of this study is to test the safety and determine the optimal dose of a new drug,     OMP-21M18, when given in combination with FOLFIRI, a standard drug treatment for advanced     colorectal cancer. Participants must not have had more than one chemotherapy regimen for     their metastatic disease. OMP-21M18 is a humanized monoclonal antibody (a protein made in the     laboratory) developed to target cancer stem cells. The way the body handles OMP-21M18 will     also be investigated.      Up to 32 participants, 21 years or older, at up to 6 centres in Australia and New Zealand,     will receive intravenous infusions of OMP-21M18 followed by FOLFIRI every two weeks, until     disease progression or limited by drug toxicity. After 8 weeks, participants will undergo     assessments to determine their disease status. If there is no evidence of disease progression     participants will continue to receive infusions of OMP-21M18 and FOLFIRI every second week,     until disease progression.   "
159949|NCT01189929|"     The purpose of this study is to test the safety and determine the optimal dose of a new     experimental drug, demcizumab (OMP-21M18), when given in combination with gemcitabine with or     without (+/-) Abraxane®. Historically, single agent gemcitabine has been the standard     treatment for pancreatic cancer. However, recent data suggests that gemcitabine plus     Abraxane® may be superior to gemcitabine alone, thus this combination is emerging as the new     standard therapy for pancreatic cancer. However, Abraxane® has not been approved for the     treatment of pancreatic cancer at this time. Demcizumab is a humanized monoclonal antibody     and was developed to target cancer stem cells. This study is sponsored by OncoMed     Pharmaceuticals, which is referred to as OncoMed or the Sponsor in this consent form. The     study is designed to test the safety of demcizumab at different dose levels when given with     gemcitabine +/- Abraxane® and the effects, both good and bad, that it has on participants.     Demcizumab may block the growth of cancer stem cells, the remaining tumor cells, and it may     also prevent the growth of new blood vessels that tumors need to grow and spread. Although     demcizumab has been administered with gemcitabine to cancer patients, it has not been given     in combination with gemcitabine and Abraxane®; thus, it is not known if it will provide any     benefit to participants and may cause harmful side effects.   "
159950|NCT01189916|"     Natural orifice translumenal endoscopic surgery (NOTES) has revolutionized the concept of     minimally invasive surgery. NOTES is currently performed through transgastric or transvaginal     approaches. The transvaginal approach is technically easier, but is only available to women.     A transrectal approach has been proposed as a potential alternative to transvaginal NOTES for     men. Fortunately, the technology to facilitate transrectal access and closure for NOTES has     been in use for over twenty years, in the form of transanal endoscopic microsurgery (TEM)     platforms.      We hypothesize that transrectal NOTES appendectomy is feasible in humans using a flexible     endoscope and a TEM platform to assist with transrectal access and closure. After a     pre-clinical study involving 5 cadavers, we will perform a clinical study of 10 transrectal     NOTES appendectomies in patients already scheduled to undergo laparoscopic total     proctocolectomy or total abdominal colectomy. The tissues involved in the NOTES procedure     will be removed as part of the patient's originally scheduled operation, reducing the risk of     morbidity as a result of an inadequate transrectal closure or appendiceal stump leak. We will     measure operative times, complication rates, peritoneal contamination, and assess the     integrity of the rectotomy closures. We hope to show that transrectal NOTES appendectomy is     clinically feasible in humans using a TEM platform.   "
159956|NCT01189838|"     Cysteine-rich 61 (Cyr61), a member of CCN family, regulates cell migration, proliferation,     apoptosis, and angiogenesis, cell adhesion, migration, proliferation, survival,     differentiation, apoptosis, angiogenesis, and extracellular matrix production. Evidences show     strong correlations of aberrant Cyr61 expression in cancers of numerous organs and tissues.     However, the expression and effect of Cyr61 in transitional cell carcinoma (TCC), the most     common urinary tract cancer in Taiwan, remains undiscovered. Based on previous studies of     Cyr61 in other cancer, the investigators hypothesize that Cyr61 may mediate TCC cell     proliferation and migration; and associated with disease progression and recurrent. Thus the     investigators conduct this project to study the role of Cyr61 in the pathogenesis of TCC. The     investigators will retrospectively review medical history of patients with TCC treated at our     institutes. Cyr61 immunohistochemical stain of their surgical samples will be performed. The     correlation of Cyr61 expression of TCC and patients' clinical courses will be investigated.   "
159957|NCT01189825|"     The major aim of the this study is to replicate findings of previous research that examined     the effects of acute exercise on sexual arousal in women in a novel population, namely, women     taking antidepressants of the selective serotonin reuptake inhibitors (SSRI) or selective     serotonin and norepinephrine reuptake inhibitors (SNRI) class. In previous studies it has     been found that acute, moderate-intensity exercise facilitated physiological sexual arousal     responses in healthy, sexually functional women. However, it is known that antidepressants     may induce sexual dysfunction, and thus in the present study, the investigators are examining     whether acute exercise may facilitate sexual responses in women with taking antidepressants,     including women with antidepressant-related sexual dysfunction.   "
159958|NCT01189812|"     The investigators hypothesize that patients receiving citalopram in combination with lithium     will have a greater reduction in depressive symptoms than patients receiving citalopram in     combination with placebo.   "
159959|NCT01189799|"     The primary objective of the study is to test the incremental efficacy and outcomes of an     aftercare program of Cognitive Behavioral Therapy combined with motivational therapy (CBT-MT)     relative to treatment as usual (TAU) in improving depression, substance use, and healthcare     outcomes in a population with drug dependence and comorbid major depressive disorder (MDD).     The investigators expect that among drug-dependent patients with comorbid MDD, CBT-MT will     yield better clinical outcomes relative to TAU in reducing depressive symptoms and substance     use and improving healthcare outcomes during treatment.      Secondary Objectives:        1. Test efficacy and outcomes of CBT-MT and TAU        2. Evaluate the differential effect of CBT-MT versus TAU on HIV-risk behavior of          participants,        3. To evaluate the impact of cognitive functioning on treatment retention and outcomes, and        4. To explore additional psychosocial, demographic, and diagnostic factors (e.g., age,          gender, education level, motivation for change, social support) that may be associated          with treatment outcome and retention in this high need population.      This study will include approximately 80 participants randomized to either 12 weeks of     motivational therapy or treatment as usual. Both treatments will meet once weekly for 60     minutes. Participants will be recruited from the Adult Partial Hospitalization program at     UCLA. During the active treatment phase, participants will attend clinic weekly for     collection of data and urine specimens.        1. For those randomly assigned to CBT-MT, they will meet with a therapist in a group format          for 60-minute sessions once weekly.           a. Each CBT-MT session will begin with 20 minutes of motivational therapy (MT), followed          by 40 minutes of CBT content.        2. Those randomly assigned to TAU, they will attend a weekly 60-minute Dual Recovery          Anonymous self-help group.   "
159960|NCT01189786|"     Participants are being asked to take part in this study because treatment of his or her     disease requires a stem cell transplant. Stem cells or mother cells are the source of     normal blood cells and lead to recovery of blood counts after bone marrow transplantation.     Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother)     for the participant and his or her disease does not permit enough time to identify another     donor (like someone from a registry list that is not his or her relative) or another suitable     donor has not been identified. However, a close relative of the patient has been identified     whose stem cells are not a perfect match, but can be used.      Alternatively, the patient may have already received a stem cell transplant but have evidence     of mixed chimerism, which means some of the patient's own bone marrow cells are present,     rather than all of the donor's cells. This may lead to an increased risk of the disease     coming back. Or, the patient may have all donor cells but his or her bone marrow is not     working very well, which may lead to frequent blood or platelet (cells that help in clotting     blood) transfusions or infection.      Regardless of the reason, it may be necessary to isolate stem cells from a haploidentical     (half-match) donor in order to provide bone marrow function. Because the stem cells from the     donor are only half-matched to the participant, the risk of graft-versus-host disease (GvHD)     is very high. GvHD is a complication after transplant caused by donor T cells (graft) that     attack the transplant recipient, and this complication can cause death after transplant.     Thus, it is important that the donor's blood cells are treated to minimize cells that are     most likely to attack the host's tissues. This is done by using a special device to capture     the CD34+ stem cells from the donor's stem cell product prior to giving the cells to the     host. This method minimizes the donor T cells, which are responsible for causing GvHD.      Purpose: In an effort to lower the occurrences and severity of graft-versus-host disease in     patients and to lower the rate of transplant failure, investigators would like to specially     treat the donor's blood cells to minimize the cells that are most likely to attack the     patient's tissues.   "
159964|NCT01189734|"     Many options are available for management of common bile duct stones. the most recent     development in this field is single-session approach by one of two methods; laparoscopic     common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the     investigators prospectively compare these two methods for management of patients with     preoperatively diagnosed common bile duct stones to settle the best option.   "
159965|NCT01189721|"     The investigators hypothesize that propofol infusion during surgery can affect the     remifentanil hyperalgesia compared to sevoflurane inhalation.The outcome will be measured by     a verbal numerical rating score (VNRS) and mechanical punctuating pain by electronic von frey     filament.   "
159966|NCT01189708|"     The aim of this study is to investigate the effect of the implantation of an Ultrapro® Mesh     as prevention of incisional hernia after elective open abdominal aortic aneurysm repair.     According to the literature these patients have an increased risk for an incisional hernia.     By the implantation of an artificial mesh into the abdominal wall during the first abdominal     aortic aneurysm repair, the risk can be reduced dramatically. In small feasibility studies     incisional hernia rates as low as 0% have been achieved.      Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into     two groups, one receiving an onlay mesh, the other conventional wound closure with sutures.   "
159967|NCT01189695|"     The objective of this study is to determine efficacy of ritonavir-boosted lopinavir     monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed     Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently received     salvage protease-inhibitor (PI) based regimens.   "
160001|NCT01189240|"     This phase I/II trial is studying the side effects and the best dose of RO4929097 to see how     well it works when given together with bevacizumab compared to bevacizumab alone in treating     patients with progressive or recurrent malignant glioma. RO4929097 may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,     such as bevacizumab, can block tumor growth in different ways. Some block the ability of     tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Giving RO4929097 together with bevacizumab may kill more     tumor cells.   "
159968|NCT01189682|"     Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine     impregnated sponge has been proven to reduce the rate of major catheter related infections in     ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). However, dressings are detached in 40% of     cases before planned changes and the rate of unplanned dressing is significantly associated     with the major catheter related infections.      Primary objective: To demonstrate that Tegaderm CHG, a new CHG impregnated dressing decrease     the rate of major catheter related infection as compared to non impregnated dressings and to     demonstrate that highly adhesive dressing decrease the rate of detached dressings.      Secondary objectives:        -  To demonstrate that the use of high performance dressing decrease the rate of unstuck          dressing and the rate of catheter infections.        -  To evaluate the tolerance of CHG impregnated gel dressings (Tegaderm CHG).        -  To calculate the cost saving of each dressings   "
159969|NCT01189669|"     This is a dietary intervention study designed to assess the impact of long chain (LC) n-3     polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS).     Considering that LC n-3 PUFA have been reported to have a beneficial affect on many of the     adverse metabolic and hormonal aspects of PCOS, it was hypothesised that dietary     supplementation with LC n-3 PUFA would have a beneficial therapeutic impact.   "
159970|NCT01189656|"     To preliminarily evaluate the efficiency and safety of therapeutic double- plasmid HBV DNA     vaccine on HBeAg-positive, chronic hepatitis B patients, and provide evidence for the next     dosing regimen.   "
159971|NCT01189643|"     This study adds irinotecan, temozolomide and bevacizumab to the chemotherapy regimen     currently used to treat Desmoplastic small round cell tumor (DSRCT). The investigators are     doing this study to find out what effects, good and/or bad, the combination of irinotecan,     temozolomide and bevacizumab has on the patient and the DSRCT cancer.   "
159972|NCT01189630|"     The Observational Study in the Real World of Implantable Electronic Cardiac Devices will     enable the construction of an electronic database with local access to clinical information,     which will collect and disseminate epidemiologic data on demography, cardiovascular mortality     and morbidity, and potential risk factors for a selected group of patients. These clinical     variables will be analyzed against the data, as based in the programming of devices and the     diagnostics. Approved descriptive statistics and analyses will be made available via     Internet. The study will describe statistical indexes on sub-groups representing more than     10% of total of datasets.      The study will be open to include any patient that had a Medtronic electronic device     implanted, pacemakers, ICD, ICD with CRP. The study will be also adapted for devices     implanted in the present and for devices to be implanted in patients in the future.   "
159973|NCT01189617|"     This is a one-week study designed to test the safety of an all-in-one body and personal     lubricant product during in-home use.   "
159974|NCT01189604|"     Phase IIB study to find the optimal dose rate range of propofol to maintain     minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal     polypectomy.   "
159975|NCT01189591|"     Sleep deprivation can acutely reverse depressive symptoms in patients with major depression.     Although underlying mechanisms of the antidepressant action in sleep deprivation are unclear,     many of these observations can be explained by abnormal slow wave homeostasis. This study     will test the prediction that selectively reducing slow waves during sleep (slow wave     deprivation; SWD), without disrupting total sleep time, will yield an antidepressant effect.   "
159976|NCT01189578|"     The purpose of this study is to compare individuals with cocaine dependence to recreational     users of cocaine in terms of their brain reactivity to cocaine cues, in hopes that this     comparison may help us better understand the transition from recreational to compulsive     cocaine use.   "
159977|NCT01189565|"     The purpose of this study is to evaluate the incidence of low levels of oxygen as determined     by standard pulse oximetry monitor in patients who have had total hip or knee     replacement/revision.   "
159978|NCT01189552|"     The objective of the current study is to evaluate the effects of a brief, behavioral     activation treatment (the Life Enhancement Treatment for Substance Use; LET'S ACT) on long     term outcomes of substance use, HIV risk behaviors and mechanisms of treatment response     (depressive symptoms, environmental reward, behavioral activation).   "
159979|NCT01189526|"     This study is designed to evaluate the efficacy of intravitreal Ranibizumab in comparison     with macular laser photocoagulation as treatments for macular edema secondary to branch     retinal vein occlusion.      Characteristics of this study is as below        1. Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs.          macular laser photocoagulation)        2. After 48 weeks follow up, functional change(visual acuity)and anatomical change (central          retinal thickness) would be evaluated   "
159981|NCT01189500|"     The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on     the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy     post-menopausal female subjects. This study will also evaluate the safety and tolerability of     Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female     subjects.   "
159982|NCT01189487|"     Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity     for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet     been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and     safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin     sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.   "
159983|NCT01189474|"     Multicentric study, open label, uncontrolled phase IV in 140 patients with meibomian glands     dysfunction .      Its objective is to Collect information from patients and ophthalmologists specialized in     ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.      This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.      Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two     uses per day) and complete a questionnaire every two days during the first week and then once     a week the next two weeks.   "
159984|NCT01189461|"     This study will asses sthe safety of pegaptanib sodium in patients with diabetic macular     edema. The hypothesis is that pegaptanib is safe and efficacious in patients with diabetic     macular edema.   "
174210|NCT00120900|"     This study was designed to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in     treating the signs and symptoms of osteoarthritis of the knee.   "
159985|NCT01189448|"     Background : When a mother contracts toxoplasmosis during pregnancy, the parasite may be     transmitted from to her unborn child. This results in congenital toxoplasmosis, which may     cause damage to the eyes and nervous system of the child. To date, no method has been proved     effective to prevent this transmission. In France, spiramycin is usually prescribed to women     who have toxoplasma seroconversion in pregnancy, however its efficacy has not been     determined. The standard treatment for toxoplasmosis is the combination of the antiparasitic     drugs pyrimethamine and sulfadiazine, but this strategy has not been evaluated for the     prevention of mother-to-child transmission.      Purpose : Randomized phase 3 trial to determine whether pyrimethamine + sulfadiazine is more     effective than spiramycin to prevent congenital toxoplasmosis.   "
159986|NCT01189435|"     The purpose of this study is to measure the ability of erlotinib to effectively treat     recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with     erlotinib or gefitinib received in the post-surgical or post-radiation setting.   "
159987|NCT01189422|"     The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and     pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively     recent onset T1DM, greater than 12 weeks and less than 52 weeks of presentation of first     signs and symptoms of disease to a physician prior to randomization.   "
159988|NCT01189409|"     This is a study to compare the efficacy and tolerability of two laxatives for treatment of     opioid-induced constipation in adult outpatients with cancer treated at the BC Cancer Agency     Pain and Symptom Management/Palliative Care clinics. Each participating patient will be     randomly assigned to one of two treatment groups.   "
159989|NCT01189396|"     The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic     profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active     control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in     escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical     dose.   "
159990|NCT01189383|"     The purpose of the study is to gather data on feasibility as well as immune and clinical     efficacy of of a dendritic cell vaccine using IL15 in patients with resected stage III or     stage IV melanoma   "
159991|NCT01189370|"     The purpose of this study is to determine whether an increase in the dose of sorafenib when     given over five instead of 7 days/week, will result in an improvement of the response rate     (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib     will control your cancer, without causing a significant increase in side effects.   "
159992|NCT01189357|"     During the period 1989-1999, a number of patients underwent a meniscal transplantation. A few     transplants were not successful. These patients form the population of this study. They all     underwent a Total Knee Prosthesis (TKP) or unicompartmental knee prosthesis (UKP) after the     failure of the transplants The goal of this study is to evaluate their current medical     condition, to perform a survival analysis, and to determine the clinical outcome.      The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS and     SF-36)and clinical examination.   "
159993|NCT01189344|"     Intestinal absorption of levothyroxine (LT4) tablets depends on its dissolution in gastric     acid secretion, which is reduced after bariatric interventions. Impaired LT4 absorption due     to low gastric dissolution has been reported in patients with atrophic or chronic gastritis.     The objective of this study is to evaluate the absorption of LT4 tablets in morbidly obese     patients before and after Roux-en-Y bariatric surgery.   "
159994|NCT01189331|"     Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical     information about stenotic lesion,but the invasiveness and measuring difficulty of FFR make     it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion     severity and lately developing computational fluid dynamics could provide functional     information. The investigators build a patient specific model of computational fluid dynamics     by CT coronary angiography and evaluate the functional significance by measuring fractional     flow reserve via CT coronary angiography and computational fluid dynamics.   "
159995|NCT01189318|"     In this study, patients with major depressive disorder (MDD) who have insomnia symptom are     treated with Seroquel XR in an open-label manner for a 4-week period with repeated     measurements of insomnia symptoms and sleep parameters using polysomnography.   "
159996|NCT01189305|"     In treating drug addiction, many studies of male patients show Behavioral Couples Therapy     (BCT) helps the whole family (the drug abuser, the relationship partner, and their children)     and is more effective than typical individual and group counseling. Only one study of BCT has     been done with female drug-abusing patients, and results were promising but not definitive.     The proposed study will test with married or cohabiting female drug-abusing patients whether     BCT will produce more positive outcomes for the women, their male partners, and their     children than standard individual counseling for the patient alone.   "
159998|NCT01189279|"     This study will investigate the safety, tolerability, and pharmacokinetics of new formulation     of bimatoprost following topical application in patients with alopecia. Two formulations of     bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be     investigated in Part 2. Part 2 will begin after Part 1 has completed.   "
159999|NCT01189266|"     This phase I/II trial studies the side effects and best dose of vorinostat and to see how     well it works when given together with radiation therapy followed by maintenance therapy with     vorinostat in treating younger patients with newly diagnosed diffuse intrinsic pontine glioma     (a brainstem tumor). Vorinostat may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor     cells. Giving vorinostat together with radiation therapy may kill more tumor cells.   "
160000|NCT01189253|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. It is not yet known whether trabectedin is more effective than     doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue     sarcoma.      PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared     with doxorubicin hydrochloride and to see how well they work in treating patients with     advanced or metastatic soft tissue sarcoma.   "
160002|NCT01189227|"     RATIONALE: Drugs used in chemotherapy work in different ways to kill tumor cells or stop them     from growing. Giving combination chemotherapy before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy     after surgery may kill any remaining tumor cells. It is not yet known whether giving     combination chemotherapy before and after surgery is more effective than giving combination     chemotherapy after surgery.      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy before     and after surgery to see how well it works compared to giving combination chemotherapy after     surgery in treating patients with colorectal cancer with liver metastases that could be     removed by surgery.   "
160003|NCT01189214|"     Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12     weeks after adjusted methadone dose. During the study, the investigators will evaluate     treatment response and adverse effect from multiple dimensions to elucidate the therapeutic     effect of add-on memantine on addictive behaviors. It will also explore the possible     advantage of this treatment on social re-adaptation and psychopathogenesis of opioid     dependence.   "
160004|NCT01189201|"     The primary objective of the current study is to investigate the relative bioavailability of     BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test)     compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference),     both in the fasting state. All 42 subjects entered are planned to be included in this     comparison.      The secondary objective is to investigate the relative bioavailability of BI 10773 /     linagliptin fixed dose combination tablet after administration of a standardised high fat,     high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin     fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the     42 subjects entered 18 subjects are planned to be included in this comparison.      An additional objective is to investigate the relative bioavailability of a second     formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation     A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet     (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned     to be included in this comparison.   "
160005|NCT01189188|"     The investigators aim to determine if ultrasound guidance results in improved technique when     drawing blood via a radial artery puncture.   "
160006|NCT01189175|"     The objective of the study is to investigate whether ketoconazole affects plasma exposure of     BI 113823   "
160007|NCT01189162|"     The investigators hypothesize that while the extremely low birthweight (ELBW) infants (<1000     g) may need NIMV for the treatment of RDS, larger infants or the smaller ones post extubation     may enjoy the comfort benefits associated with HFNC while getting coparable respiratory     support to NIMV.   "
160008|NCT01189149|"     Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV)     fluids in hospitalized infants with acute viral bronchiolitis.   "
160009|NCT01189136|"     If patients are unable to have their foley catheter removed because their bladder is not     emptying well, they may be eligible for study participation. This study is designed to     evaluate whether Posterior Tibial Nerve Stimulation is effective in improving bladdder     function after surgery. Study participation is limited to one day.   "
160010|NCT01189123|"     This study is to study the immune response to the flu vaccine in people 65 years old and     older. Only adults 65 years old and older and who are getting their flu vaccine are being     asked to join in this study. The investigators plan to enroll approximately 100 people in     this study in the 2010-2011 flu season. Vanderbilt is working with the Centers for Disease     Control and Prevention on this study.      There will be 5 study visits. Up to 4 tablespoons of blood from a vein will be obtained prior     to the flu shot. Return visits will be 1, 2, and 4 weeks later,with up to 4 tablespoons of     blood drawn again. Patients will be randomized to receive either the standard dose or the     high dose flu vaccine. Both flu vaccines are FDA-approved.   "
160035|NCT01188798|"     The purpose of the study is to determine if participants who receive the GVHD prophylaxis     medication pentostatin will have less severe hepatic toxicities than those receiving MTX. The     study is estimated to have sufficient statistical power to ascertain at least a 20%     improvement in day 42 NCI CTC grade 2 or above hepatic toxicity-free survival in pentostatin     recipients.   "
160011|NCT01189110|"     Thirty three percent of our veterans currently smoke. Encouraging smoking cessation continues     to be a top priority for the Veteran's Administration as smoking is the single most important     preventable risk factor for mortality and morbidity. This study attempts to determine whether     auriculotherapy may be used as an effective alternative to usual pharmacological     interventions currently offered. Identifying an efficacious alternative method to nicotine     patch or bupropion would be highly beneficial to veterans who want to quit smoking. This     clinical trial took place at the Veterans Administration Medical Center, in conjunction with     the smoking cessation clinic. One hundred twenty five veterans, male and female, age 19 or     older, who smoked a minimum of 10 cigarettes per day, were evaluated for enrollment and     randomized to two groups- true auriculotherapy and sham auriculotherapy in this 6 week trial.   "
160012|NCT01189097|"     The purpose of this study is to determine the pharmacological effects and outcomes of DM     therapy with this add-on study.      And to determine the immunological changes between the baseline and the end point of the     study.   "
160013|NCT01189084|"     The purpose of this observational study is to determine whether the vaccine (UB 311),     targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term     immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's     disease (AD) who previously received UB 311-treatment. Amyloid beta was selected as the     target antigen based on supporting evidence of the hypothesis that places the accumulation of     amyloid beta at the initiating step of AD.   "
160105|NCT01187888|"     The purpose of this study is to determine whether rasagiline is effective in the treatment of     Progressive Supranuclear Palsy (PSP), a rapidly progressing disease with a symptomatology     similar to Parkinson's Disease. The major aim of this study is the limitation or halting of     the process of neurodegeneration and influence postural instability.   "
160374|NCT01184378|"     The great majority of infants formula contain fats exclusively from vegetable oil.     Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an     infant formula closer to the nutritional composition of maternal milk.   "
160014|NCT01189071|"     This will be a randomized two arm prospective study to evaluate postoperative ureteral stent     pain. One arm will be given 3 days of preoperative darifenacin and the control group will     have the standard of care which is no preoperative anticholinergic medication. The primary     endpoints will be decreased pain scores and less ER visits and hospital admissions for stent     difficulty. These will be assessed by a pain diary completed by the participant as well as a     questionnaire when the participant returns to clinic for stent removal. Also included in     evaluation of the primary end point will be patient phone calls, ER visits and admissions for     stent difficulty. Secondary endpoints will be narcotic and postoperative anticholinergic use.     This will also be assessed with the pain diary completed by the participant. Participants     will be included in the study if they are undergoing a procedure that a stent will likely be     required. This will include participants who will have ureteroscopy or extracorporeal shock     wave lithotripsy and a stone 1 cm or larger. Also participants with stones smaller than 1 cm     who due to anatomy of the ureter or kidney will likely need a stent on preoperative     evaluation will also be included in the study. Included as well in the study are participants     who will undergo renal or ureteral surgery that a ureteral stent will be utilized.     Participants will be randomized after consent is obtained into two groups. One group will     receive standard of care which is no preoperative anticholinergic medications. The second     group will receive the three day treatment with darifenacin pre procedure. Participants in     the second group will be instructed on side effects of darifenacin and given appropriate     contact information prior to initiation of the medication. Both groups will be followed     postoperatively with a pain diary. Postoperative follow up will continue until the stent is     removed 1-2 weeks after the procedure. The exact time of stent removal will depend on the     success and nature of the surgery and will be at the discretion of the surgeon. Participants     will be able to voluntarily stop the medication for any reason as well as if they have     serious side effects from the medication. Data to be collected from each group includes age,     gender, race, prior ureteral stents, prior renal or ureteral surgery, past medical history,     allergies, current medications and urinary complaints.   "
160015|NCT01189058|"     Newborn stroke is the leading cause of a common type of cerebral palsy (CP) that affects     thousands of Canadian children and families. Treatments for CP are generally ineffective, and     have traditionally focused on the weak body rather than the injured brain. Understanding how     the newborn brain responds to injuries like stroke (plasticity) carries the greatest     potential for better treatments. We propose to study the ability of two interventions to     modulate brain plasticity toward better function in children with stroke-induced CP. One is a     rehabilitation method called constraint-induced movement therapy (CIMT), the other is a type     of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS is safe     and comfortable for children and we recently showed it could improve motor function in     children with stroke.      We will perform a special study to test both treatments simultaneously. Children 7-18 years     with stroke-induced CP will be recruited into the study from across Alberta. Each child will     randomly receive either TMS, CIMT, both, or neither each day for two weeks while attending     our new HemiKids Power Camp for motor learning. Improvements will be measured by trained     therapists over 1 year. TMS will also measure brain plasticity, both initially and following     treatment. Our lead investigator is an expert in both newborn stroke and TMS and has     assembled an experienced team of accomplished collaborators to ensure the completion of this     important work. This will be the largest study of children with CP examined in this manner.     This will be the first clinical trial of non-invasive brain stimulation (TMS) in CP, the     largest trial of CIMT (and the first exclusive to newborn stroke), and the first study     allowing the direct comparison of two different therapies. In establishing the first     dedicated pediatric TMS laboratory in Canada, we will be the first to measure plasticity     changes in newborn stroke, advancing new treatments of this previously untreatable and     disabling disease.      Patient recruitment is currently underway at Alberta Children's Hospital. Application is     currently underway to expand recruitment to Northern Alberta through the Glenrose     Rehabilitation Hospital and Stollery Children's Hospital, to enable patients from Northern     Alberta greater opportunity to participate as subjects in this study.   "
160016|NCT01189045|"     Little is known about how exercise can affect heart function in stroke survivors.      This study will look at changes in cardiovascular fitness and function after 6 months of     exercise. Volunteers will be tested before and after the program and again 2 months later to     measure the effects on stroke risk factors, fitness level and flexibility of the arteries.     Blood tests will measure cholesterol levels and other signs of inflammation.      This study will help us better understand how exercise after stroke can improve heart     function and heart health, and ultimately help in lowering future stroke risk.   "
160017|NCT01189032|"     Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in     patients with dry eye, using a multicenter, randomized, double-blind, parallel group     comparison study, and the optimal concentration is determined.   "
160018|NCT01189019|"     In this fifth year of anti-VEGF therapy for neovascular AMD, retinal physicians are     collecting groups of patients who either do not or only partially respond to anti-VEGF     therapy. This study will evaluate the efficacy and safety of 2mg ranibizumab specifically for     patients with fibrovascular PEDs that have not resolved following at least 6 consecutive     injections of ranibizumab or bevacizumab over the previous 12 months. The investigators     hypothesize that the 2mg dose will be able to completely eliminate the persistent PEDS in     these patients.   "
160019|NCT01189006|"     These results suggest that the DA neuroprotection provided by DM in the inflammation-related     neurodegenerative models is not mediated through the NMDA receptor.   "
160020|NCT01188993|"     The purpose of this study is to assess the concordance of therapeutic changes proposed after     an early hemodynamic evaluation (hemodynamic profile) in septic shock patients using jointly     the transpulmonary thermodilution technique and transesophageal echocardiography (TEE).   "
160021|NCT01188980|"     The purpose of this study is to determine if early Barrett's specialized intestinal     metaplasia can be detected by measuring early increased blood supply of the esophageal     tissue, with 4 Dimensional Elastic Light-Scattering Fingerprinting, (4D-ELF) technology in     real time.   "
160022|NCT01188967|"     The purpose of this research study is to find out if an investigational drug, GSK598809 can     help people who have very recently quit smoking; the investigators want to find out if     continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. To     relapse means you fall back into smoking again after quitting. The investigators also want     to find out if GSK598809 is safe to take without causing too many side effects.   "
160023|NCT01188954|"     A seroma is a collection of fluid other than pus or blood which forms through the division of     numerous lymphatic channels, which normally drain the interstitial space under the skin.     These channels become disrupted during surgical procedure and lead to seroma formation. This     collection of fluid causes pressure in the local area, patient discomfort, and provides     unfortunately an excellent culture medium for bacteria. Seroma development has been     previously described in femoral vessel groin cannulation dissections after surgery.     Conventional therapy is limited to draining the fluid, sometimes more than once, until there     is full resolution of the seroma. If fluid collection recurs at the surgical site, sclerosant     therapy with agents such as doxycycline. Doxycycline has been found to be a cost effective     agent used as a sclerosant, which belongs to tetracycline class of antibiotics. The     investigators hypothesize that prophylactic use of doxycycline at the site of femoral     cannulation will prevent or minimize the area of seroma formation as compared to standard     care of patients. The aim is driven towards limiting patient discomfort and visits to the     clinic and to improve clinical care.   "
160106|NCT01187875|"     Dietary fiber consumption may contribute to weight regulation by improving satiety. In an     earlier study the investigators found that a muffin containing resistant starch was more     effective than other fibers in altering satiety. The objective of this study is to determine     if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant     starches is more effective than either alone in enhancing satiety.   "
160024|NCT01188941|"     The purpose of this study is to test the effects of a health system navigator intervention on     rates of linkage to human immunodeficiency virus (HIV) and tuberculosis (TB) care among newly     diagnosed HIV-infected outpatients in Durban, South Africa. Subjects will be approached in     the outpatient department and enrolled prior to an HIV test. Subjects will then be randomized     to the navigator arm or the standard of care arm. Subjects in the navigator arm will receive     scheduled phone and short message service (SMS) contacts throughout the follow-up period to     help guide them through the HIV and TB care pathways. The navigator will provide personalized     support to help subjects overcome barriers they may face along the way.   "
160025|NCT01188928|"     The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus     Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when     used individually as monotherapy in the topical suspension vehicle (betamethasone     dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension     vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris     on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This     comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol     50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also     establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of     the body (trunk and/or limbs).   "
160026|NCT01188915|"     After treatment for Hodgkin disease, secondary cancer, in particular breast cancer induced by     treatment, are the first cause of death.      The investigators will estimate the risk to develop breast cancer in this population of women     treated for hodgkin disease, and will propose women at high rish to participate in an     intensive screening program based on an annual detection based on mammography, echography,     and RMI.   "
160027|NCT01188902|"     The objectives of the proposed study are to assess the effect of walnut consumption on     parameters of lipid metabolism, glucose metabolism, incretins and adipokines, endothelial     function and blood pressure in healthy men and healthy postmenopausal women   "
160028|NCT01188889|"     Patients participating in this study will have a diagnosis of Chronic Myeloid Leukemia. This     study will evaluate whether the addition of an investigational drug called RAD001 given     together with Imatinib will better target leukemia stem cells, causing them to die. Stem     cells are a small population of cells, existing primarily within the bone marrow, and are     believed to be responsible for the ongoing risk of disease relapse.   "
160029|NCT01188876|"     Pralatrexate is a type of antifolate drug which means is restrains the production of folic     acid in the body. Folic acids are used by tumors to increase tumor cell growth and division.     It is believed that reducing folic acid will hinder the rapid division of tumor cells, their     growth and production. Carboplatin is an FDA approved chemotherapy drug for ovarian,     fallopian tube and primary peritoneal cancer. Some antifolate drugs are used with other     chemotherapy drugs to enhance cancer-fighting characteristics. It is believed that the study     drug pralatrexate may improve the anti-tumor effect of carboplatin. In this research study we     are looking for the highest dose of pralatrexate that can be given safely in combination with     carboplatin.   "
160030|NCT01188863|"     This protocol is intended to compare the effects of both a solid (tablet) and liquid oral     dosage form of LX4211 in subjects with type 2 diabetes mellitus.   "
160031|NCT01188850|"     DNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages     over traditional vaccines such as live attenuated virus and recombinant protein-based     vaccines. DNA vaccines appear to be well tolerated in humans. Therefore, the investigators     have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of     both HPV subtypes 16 and 18. The investigators have chosen to deliver our candidate vaccines     via electroporation (EP) using the CELLECTRA constant current device to deliver a small     electric charge following intramuscular (IM) injection, since animal studies have shown that     this delivery method increases the immune response to our DNA vaccine leading to a decrease     in the size of tumors caused by HPV 16 and 18. In study HPV-001, the vaccine was given to     subjects with a history of CIN 2 and 3 who had been previously treated by surgery. This study     is proposed to vaccinate the same subjects with a fourth dose of the VGX-3100 to determine     the safety and immune response.   "
160032|NCT01188837|"     Common medical therapies for knee osteoarthritis are patient education, drug and physical     therapy, exercise and surgery. These modalities may offer improvement but drugs and surgery     carry significant risk. Manipulative therapy for KOA gives pain relief and increased     function. However, research suggests addition of manipulative and soft tissue therapy (to the     entire kinetic chain: lumbosacral, sacroiliac, hip, knee, ankle and foot joints), may give a     better outcome. Exercise therapy is considered an effective and standard care for KOA.   "
160033|NCT01188824|"     The purpose of this study is to investigate the Safety and Efficacy of Cilostazol in slowing     down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with     PAD in Taiwan.   "
160034|NCT01188811|"     The purpose of the study is to determine if lipoic acid can protect the brain and slow     disability in secondary progressive multiple sclerosis.   "
160551|NCT01182038|"     The purpose of this study is to determine whether birth on a birthing seat will effect     numbers of instrumentally assisted vaginal births, vaginal traumas, blood loss,use of     artificial oxytocin for labour augmentation and fetal outcomes.   "
160036|NCT01188785|"     Phase 0 - Open label, Single dose study of siG12D LODER in Patients with operable     adenocarcinoma of the pancreas.      The primary endpoint:      To assess efficacy and local distribution of siRNA out of eight high dose siG12D LODERs in     patients diagnosed with operable adenocarcinoma of the pancreas.      The Secondary endpoint:      Short term tolerability and safety assessment      Phase I - This study is designed to investigate the safety of siG12D LODER (Local Drug     EluteR) in patients diagnosed with adenocarcinoma of the pancreas.      The primary endpoint:      To asses efficacy of siG12D LODER and local distribution in non-operable patients by     histopathology measurements, local distribution by RNA analysis.      To define the dose-limiting toxicities (DLT)      The Secondary endpoint        1. To determine the recommended Phase II dose (RP2D)        2. To define and maximum tolerated dose (MTD)        3. In the event of surgery, assessment of siG12D LODER local distribution and efficacy will          be based on histopathology measurements and RNA analysis.        4. Progression free survival - only by long term follow-up   "
160037|NCT01188772|"     Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to     receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated     interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to     an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA     level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a     2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA < lower     limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks of     PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.      Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400     mg plus PEG+RBV for 12 weeks.   "
160038|NCT01188759|"     This study aims to compare the safety, tolerability, and efficacy of voriconazole and     anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17     years with invasive aspergillosis.   "
160039|NCT01188746|"     The purpose of this study is look at how treatments for ascites affect quality of life. Your     quality of life is the ability for you to enjoy the normal things you do. Ascites (pronounced     as-ī-tees) is the presence of extra fluid in the abdomen. Sometimes ascites is caused by     cancer, also called malignancy.      All people who participate in this study have ascites associated with cancer. Ascites can     cause symptoms that make it difficult for the patient to do simple things. Patients with     ascites often report:      Abdominal swelling Difficulty walking. Difficulty breathing. Feeling full when eating.     Clothes not fitting due to a swollen abdomen. Swelling in the legs. It is hoped that this     catheter will relieve the symptoms of the ascites. The goal of the investigators study is to     understand the quality of life before the procedure and after the procedure. Since the     patient is having this procedure to make their symptoms better, the investigators want to     hear from the patient of how the procedure has affected their quality of life.   "
160040|NCT01188733|"     Octreotide is used to control variceal bleeding. However, octreotide has to be given through     the vein and is effective for less than two hours.      In this study the investigators determined whether a long-acting preparation of octreotide     (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal     pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.   "
160041|NCT01188720|"     Preliminary findings from a trial in the investigators laboratory suggest that acute exercise     may ameliorate deficits in sexual arousal associated with use of antidepressants. The goal of     this project is to evaluate the real-world effectiveness of an exercise-based intervention     for these side effects in a community-based sample. The investigators hypothesize that     general exercise will help improve sexual functioning in women taking antidepressants, and     that exercise immediately before sexual activity - that is, acute exercise - will have an     additional beneficial effect above and beyond that of general exercise.   "
160042|NCT01188707|"     The Belinostat-Erlotinib trial is designed as an open, non randomized phase I / II trial to     assess the efficacy and safety of Belinostat in combination with Erlotinib in patients with     non-small cell lung cancer who are eligible for treatment with erlotinib.   "
160043|NCT01188694|"     Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a     traumatic event and intense, persistent feelings of anxiety. There are several effective     therapies for PTSD, but they are often time consuming. The investigators want to see if the     investigators can shorten treatment time while keeping therapy effective by adding a     medication called methylene blue, USP, taken orally as a pill, to the therapy. The specific     aims are: 1) To see whether medication plus psychotherapy improves PTSD symptoms more than     placebo plus psychotherapy or a waitlist; 2) To examine the long-term outcome of those     receiving medication plus psychotherapy 1 and 3 months after treatment has ended; 3) To     examine whether medication plus psychotherapy helps with depression, trauma-related     cognitions, and functioning.   "
160044|NCT01188681|"     The objective of the first part of the study is to determine a safe dose of TRU-016 that can     be used in combination with bendamustine in patients with relapsed CLL. The objectives of the     second part of the study are to compare the safety and efficacy of TRU-016 in combination     with bendamustine to bendamustine alone in patients with relapsed CLL.   "
160045|NCT01188668|"     The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine     Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy     adult subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine     SR and Aripiprazole when coadministered to healthy adult subjects.   "
160046|NCT01188655|"     This observational study will be a documentation of the prescribing and administration     practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real     life setting.   "
160047|NCT01188642|"     Obesity is now becoming significantly prevalent of an environment characterized by easily     available calorics foods combined with sedentary lifestyles. Moreover, it has been     demonstrated that obesity is associated with metabolic complications such as disturbed     adipocytokines, hormones secreted by adipose tissue. Given these observations, the purpose of     this study is to assess the effects of a lifestyle intervention focused on various physical     activities and nutrition education on adipocytokines hormones, in severely obese teenagers.   "
160552|NCT01182025|"     The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for     mild type of hand, foot, and mouth disease.   "
160048|NCT01188629|"     Interactive telephony technologies offer a potentially highly effective, patient-centered     communication modality by guiding parents at home through interactive discussions that can     gather information and actively reinforce recommendations and treatments. Interactive     telephony systems are particularly well suited for use in vulnerable populations since access     to the telephone is nearly universal, and the system does not rely on reading printed text.     The investigators propose to develop and evaluate an integrated patient-centered health     information system, the Personal Health Partner (PHP). The PHP will use fully automated,     interactive, conversations to gather personal health data and counsel parents before     scheduled visits, exchange that data with the child's primary care clinician via the     electronic health record (EHR), and offer personalized follow-up assessment and counseling     after visits. The information technology-based approach to be evaluated in this project will     link parents and children outside the clinical setting with their primary care center and     will offer comprehensive assessments AND counseling to reinforce and support parental     behavior change.   "
160049|NCT01188616|"     The goal of this exploratory/ developmental study is to develop and evaluate an integrated     information system, Healthy Eating and Activity Today (HEAT), for promoting self-care in     overweight children. HEAT is comprised of two components: 1)Telephone Linked Care-HEAT     (TLC-HEAT), a self-care intervention delivered at home through totally automated telephone     conversations; and 2) Primary Care-HEAT (PC-HEAT), a primary care intervention linked with     TLC-HEAT and delivered through an electronic health record (EHR). The HEAT system will guide     children in the early stages of overweight, i.e., children with Body Mass Index (BMI) 0-3 BMI     points above the 95th percentile for age and gender, toward healthy weight management and     assist the child's parent(s) and primary care provider (PCP) to support the child's efforts.   "
160050|NCT01188603|"     This trial examines the way flibanserin is metabolized in postmenopausal women with     Hypoactive Sexual Desire Disorder.   "
160051|NCT01188590|"     The purpose for the investigators study is to investigate the severity and incidence of     respiratory insufficiency using transcutaneous carbon dioxide (TcPCO2) monitoring as an     adjunct to the current standard of care for early detection of inadequate ventilation in     post-operative surgical in-patients undergoing cardiac surgery after discharge from intensive     care unit (ICU) or post anesthesia recovery unit (PACU).   "
160052|NCT01188577|"     This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine     Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled     epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous     epinephrine, in healthy male and female adult volunteers. The current study is designed for a     more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated,     under augmented dose conditions.   "
160053|NCT01188564|"     This study is being conducted to confirm the efficacy, safety, and immunogenicity of     recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of     acute angioedema attacks in Hereditary Angioedema (HAE) patients.   "
160054|NCT01188551|"     This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following     anesthesia induction in patients undergoing myringotomy and placement of pressure     equalization (PE) tubes in providing analgesia and smoothing emergence from general     anesthesia.   "
160055|NCT01188538|"     The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene     0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.   "
160056|NCT01188525|"     The study aims to descibe the pharmacokinetics of 10 substrates of enzymes involved in drug     metabolism and their metabolites, after administration singly and simultaenously at     predefined doses in 10 health volunteers.   "
160057|NCT01188512|"     The purpose of this study is to evaluate the safety and immunogenicity of a new live     attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating,     placebo-controlled study on a genetically modified B. pertussis strain given as a single     intranasal dose to healthy adult male volunteers.      Effective vaccines are needed to protect young infants (from 0 to 6 months, today the most     vulnerable age group), preferably after a single administration very early in life. The     successful outcome of this project would constitute an important milestone towards nasal     vaccination of infants, possibly at birth with a novel, single-dose pertussis vaccine. Our     ultimate aim is to protect infants in the most vulnerable age group, before the regular     vaccination schedule using already available vaccines is applied. The ultimate aim is thus     not to replace current vaccination schedules with available vaccines, but to add a first     nasal vaccination to protect very early in life.   "
160058|NCT01188499|"     This is a dose escalation safety study of birinapant (TL32711) in combination with     chemotherapy in subjects with advanced or metastatic solid tumors.   "
160059|NCT01188486|"     Non-small cell lung cancer (NSCLC) is the most deadly cancer in the world. NSCLC annually     causes 150,000 deaths in the US and greater than 1 million worldwide. The standard treatment     for early stage NSCLC is lobectomy with lymphadenectomy. However, many patients are poor     operative candidates or decline surgery. An emerging alternative is Stereotactic Body     Radiation Therapy (SBRT). Mounting evidence from Phase I/II studies demonstrates that SBRT     offers excellent local control. Most SBRT trials focused on small, peripheral tumors in     inoperable patients. Increasingly, clinical trials study SBRT in operable patients, often     with larger, central tumors.      Using clinical staging, a significant proportion of patients harbor occult nodal metastases     when undergoing SBRT to the primary tumor alone. Subgroups of patients carry even higher risk     of nodal metastases. These nodal metastases frequently would be removed by surgical     intervention. However, SBRT, at present, is only directed at the primary tumor, potentially     leading to regional failures in otherwise curable patients. To increase the effectiveness of     SBRT for lung tumors, the next logical step is to explore whether the highest risk areas of     disease spread can be identified and targeted. Regional failure could be reduced and outcome     improved in a significant proportion of patients treated with SBRT if the primary nodal     drainage (PND) were identified, targeted and treated in addition to the primary tumor.      We propose to conduct a study to determine how well water soluble iodinated contrast material     when injected directly into the tumor can be visualized on CT scan and integrated into     radiation therapy treatment planning.   "
190846|NCT00347594|"     The purpose of this study is to measure the aberrations, corneal surface topography and     pachymetry of normal human eyes with the NGDI.   "
160060|NCT01188473|"     Status asthmaticus is recognized as a common cause of morbidity in children in the United     States. In recent years, hospitalization rates have reached an all time high. This study will     evaluate the safety, tolerability and clinical benefit of adding Noninvasive Positive     Pressure Ventilation (NPPV)to regular care in children with moderate to moderately severe     status asthmaticus.   "
160107|NCT01187862|"     The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called     Basel cocktail) can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9,     CYP2C19, CYP2D6, CYP2E1 and CYP3A4.   "
160108|NCT01187849|"     The purpose of this study is to evaluate if a treatment with metformin compared to placebo     reduces metabolic side-effects in patients with glucocorticoid treatment over three months     time.   "
160428|NCT01183663|"     The goal of this clinical research study is to find the highest tolerable doses of the     combinations of lenalidomide and other drugs that can be given to patients with advanced     cancer. The safety of the drug combinations will also be studied.   "
160061|NCT01188460|"     This study will test the impact of a cognitive-behavioural self-management approach for the     management of insomnia among patients with chronic pain. This self-management approach     consists of a manual describing cognitive behavioural techniques for the management of     insomnia. In terms of primary outcomes, it is anticipated that there would be improvements in     sleep-related dimensions such as sleep quality, sleep efficiency, and night-time awakenings     in the sample group receiving a copy of the self-help manual intervention to be implemented     by participants in their home (intervention group), relative to the group receiving treatment     as usual (control group). In terms of secondary outcomes, it is anticipated that the     intervention group will show improvements in mood, fatigue, pain severity, and pain-related     disability relative to the control group. The tertiary outcome variable of pre-sleep arousal     is anticipated to have a moderating or mediating relationship with the sleep variables     investigated.   "
160062|NCT01188447|"     The goal of this cohort study is to evaluate the safety and potential impact of an active     strategy that allows paramedics to assess very low-risk trauma patients with the Canadian     C-Spine Rule (CCR) and transport them to the Emergency Department without immobilization. The     specific objectives of the study are to determine safety, determine the clinical impact and     evaluate performance.   "
160063|NCT01188434|"     This Research Plan proposes Stage 1 Research integrating evidence based practices to address     the needs of mothers referred to child welfare for substance abuse. Mothers with a history of     methamphetamine abuse and child neglect will be recruited. Using an intensive community based     treatment, mothers will receive substance abuse treatment combined with parenting skills     training and psychosocial support for basic needs (e.g., housing, employment). This project     will include a feasibility study (n = 5), followed by a small randomized pilot (n = 24) to     examine the efficacy of the Integrated Treatment for Substance Abuse and Neglect compared to     treatment as usual, with a population of substance abusing neglectful mothers referred     through the Department of Child Welfare.   "
160064|NCT01188421|"     This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A     randomized, double blind clinical trial comparing the efficacy and safety of tramadol to     clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be     conducted. Opioid dependent participants will be treated on a residential unit. The primary     outcome measure is opioid withdrawal symptoms.   "
160065|NCT01188408|"     LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc.     Docetaxel (currently marketed as Taxotere) is an anti-microtubular network agent and is one     of the most active agents in the treatment of metastatic castrate resistant prostate cancer     (CRPC) and other variety of cancers. Taxotere has poor solubility and is designed to be     administered with Tween 80 in ethanol. This vehicle causes acute hypersensitivity reaction.     By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced toxicity and     comparable therapeutic efficacy in pre-clinical study. The clinical evidence obtained from     the NeoPharm Phase I study shows fewer side effects and possibly administered at higher dose     to induce greater effectiveness of LE-DT. The current Phase II study is designed to     accomplish the following objectives:        1. Assess the antitumor effect indicator serum prostate specific antigen (PSA) following          the intravenous (IV) administration of 110 mg/m2 LE-DT every three weeks in patients          with metastatic castrate resistant prostate cancer        2. To evaluate the measurable soft tissue disease response using the response evaluation          criteria in solid tumor (RECIST) methodology        3. To evaluate the progression-free survival (PFS) and overall survival (OS)        4. To correlate PSA expression with tumor response        5. To evaluate the safety of LE-DT at 110 mg/m2 level, in particular peripheral neuropathy,          water retention as well as myelotoxicity        6. To evaluate the quality of life (QOL)   "
160066|NCT01188395|"     The aim of this study is to explore relation between the comorbidity of different bipolar     disorders with alcoholism and neuropsychiatric function and candidate genes. The     investigators plan to establish genetic validity for this subtype of alcoholism. In addition,     by comparing this subtyped alcoholism to normal control, the investigators plan to examine     the genetic validity of such comorbidity. The investigators plan to find specific clinical     characteristic from neuropsychiatric aspects of such subtype for future early diagnosis,     prediction and prevention.   "
160067|NCT01188382|"     Objective. The intracranial pressure and cerebrospinal outflow resistance are essential     parameters to describe the cerebrospinal fluid dynamic system. Outflow resistance effects     intracranial pressure, pulse amplitudes, cerebrospinal fluid absorption as well as the     compliance of the system. The objective of this study was to determine the reference values     in the elderly.      Methods. Elderly people (60-82 years), considering themselves healthy, were recruited through     an ad in the local paper. All were evaluated with a 3 Tesla magnetic resonance imaging     apparatus. Subjects were eligible if they did not have any psychiatric or neurological     disorder or signs of advanced atherosclerotic disease. Intracranial pressure and outflow     resistance were determined by a constant pressure infusion method with the patient in the     supine position. The study population consisted of 40 subjects (mean age 70 years; 23 women).   "
160068|NCT01188369|"     This is a clinical, randomised, double-blinded study in which patients eligible for aortic     valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4     hours prior to surgery and until the end of surgery.   "
160069|NCT01188356|"     The purpose of this study is to evaluate the incidence and evolution over-time of     co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2     years follow-up.   "
160082|NCT01188187|"     This Phase 3 study has been designed to confirm that adding custirsen to standard first-line     docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes     compared to standard first-line docetaxel/prednisone treatment alone. This will be a     randomized, open-label, multicenter, international trial. Treatment will consist of     docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients     will be randomized. Patients will be randomly assigned with equal probability to the two     arms.   "
160109|NCT01187836|"     In this study, TRV120027 (or a placebo) intravenous infusion will be given to people with     heart failure to learn about the effects of TRV120027. The results of this study will help     choose the proper range of TRV120027 doses to use in future research studies involving     patients with acute decompensated heart failure.   "
160070|NCT01188343|"     This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus     vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at     separate visits 6 weeks apart in toddlers aged 12 to 18 months.      Primary objective:        -  To demonstrate the non-inferiority of the antibody responses in terms of seroconversion          of the concomitant administration of JE-CV and MMR compared to the antibody responses          after the single administration of JE-CV and MMR vaccine.      Secondary objectives:        -  To describe the immune response to JE CV and MMR before and after one dose of JE CV and          MMR vaccine, respectively.        -  To describe the safety of a single dose of JE-CV and MMR vaccine (given separately at a          6-week interval and the safety of the concomitant administration of JE-CV and MMR          vaccine in all subjects up to 6 months after last vaccination.   "
160071|NCT01188330|"     Acute myeloid leukaemia (AML) is a disease of the elderly, with a median age at diagnosis of     65. A poor outcome in this population has been well established, with very short overall     survival (OS) and disease free survival (DFS).There are numerous bad prognostic factors     related to the disease itself or to the patient's medical condition.      This study will evaluate the impact of a Comprehensive Geriatric assessment (CGA) performed     at diagnosis with planned interventions according to disabilities and monthly follow-up by a     nurse practitioner during 6 months on functional status of older cancer patients treated for     Acute myeloid leukaemia. Functional status will be assessed with the Lawson Instrumental     Activities of Daily Living (IADL) scale at diagnosis and 6 months after randomisation.   "
160072|NCT01188317|"     This randomized, double-blind, placebo-controlled, parallel group study will investigate the     safety and tolerability, and the effect of aleglitazar in combination with ibuprofen on renal     function, renin-angiotensin system and pharmacokinetics in healthy volunteers. Volunteers     will be randomized to receive daily doses of aleglitazar or placebo in combination with     ibuprofen. The anticipated time on study drug is 5 weeks.   "
160073|NCT01188304|"     This randomized, double-blind, placebo-controlled, parallel group study will investigate the     safety and tolerability, and the effect of aleglitazar in combination with aspirin on renal     function, renin-angiotensin system and platelet aggregation in healthy volunteers. Volunteers     will be randomized to receive daily doses of aleglitazar or placebo in combination with     aspirin. The anticipated time on study drug is 5 weeks.   "
160074|NCT01188291|"     The purpose of this study was to measure the retinal nerve fiber layer (RNFL) thickness in     eyes of Obstructive Sleep Apnea/hypopnea syndrome (OSAHS) using optical coherence tomography     (OCT), and assess whether it is decreased. The investigators then compared the results with     healthy subjects database of RNFL thickness from another retrospective study.   "
160075|NCT01188278|"     The purpose of this study is to determine predictive value of Hammersmith score on Complete     Cytogenetic Response (CCyR).   "
160076|NCT01188265|"     Dextromethorphan has been reported affording neuroprotection on dopaminergic neurons and     having protective effect against inflammation-related neuron damage. These anti-inflammatory     and neuroprotective effects of dextromethorphan would suggest potential clinical benefits of     dextromethorphan add-on therapy to valproate for bipolar disorder patients. This hypothesis     was based on the findings that the mood stabilizers have been reported to be neuroprotective     through the release of neurotrophic factors such as GDNF from astroglia. Thus, the     combination treatment of mood stabilizers and dextromethorphan might improve the therapeutic     efficacy for bipolar disorder patients.   "
160077|NCT01188252|"     Clinical study to determine safety, tolerability, to measure how the drug is metabolized by     the body and to determine the maximum tolerated dose of BAY1000394 given in an intermittent 3     days on / 4 days off schedule to patients with advanced malignancies   "
160078|NCT01188239|"     The study's major aim is to investigate the ability of a commercial Electronic Nicotine     Delivery Device (E-Cigarette) loaded with low dose nicotine to induce long-term smoking     reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes     in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette     and smoking is safe. The study will monitor smoking reduction/abstinence effects, changes in     withdrawal symptoms, and adverse events of a currently marketed device in Italy (Categoria     electronic cigarette) using initially for 6 weeks ORIGINAL 7.4 mg nicotine cartridges     followed by a further 6 weeks of CATEGORIA 5.2 mg nicotine cartridges. The primary     hypothesis is that the E-Cigarette used in a structured protocol is a safe device that allows     smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and     cravings.   "
160079|NCT01188226|"     The majority of teeth utilized in the fabrication of conventional complete dentures are made     of acrylic resins. These acrylic teeth provide increased bond strength to the denture base     and are much easier to adjust for correct denture occlusion compared to teeth made of harder     materials, such as porcelain. However, the acrylic teeth will wear faster than the porcelain     teeth, leading to alterations in how the teeth contact each other if the denture is not     replaced periodically (typically every 5-8 years). With the increase in biting and chewing     forces that can be achieved during function with dentures supported by dental implants, the     rate of tooth wear may be increased, leading to more frequent need for replacement of the     prosthesis. Acrylic teeth made of nano hybrid composite material (NHC) potentially offer     greater wear resistance and aesthetic characteristics. The NHC teeth employ a wide range of     fillers, including highly cross-linked organic macrofillers, high-density inorganic     microfillers and silanized silica based nanofillers. The macrofillers are, to a large part,     responsible for the adequate strength and color-stability of the teeth, whereas the     microfillers improve the wear resistance. The nanofillers offer fundamentally different     optical behaviour from those of larger fillers, improving light reflection without lowering     the translucency. This offers additional opportunities in the development of composite teeth,     which have to exhibit lifelike aesthetics and translucency. These teeth made of     nano-particles and hybrid composites can be made with two different techniques, one where the     materials are pressed together and another using an injection technique. The injection method     has been found to have better aesthetic results, but resistance to wear in clinical use has     not been established.      The purpose of this study is to evaluate the wear characteristics of new resin denture teeth     (nano particles - hybrid composite) made by an injection technique. Twenty-four edentulous     subjects will be enrolled who have completed implant placement for mandibular implant     overdentures opposing a maxillary complete denture or implant overdenture, or patients that     have previously received these dentures and are interested in having new dentures. Both     maxillary and mandibular dentures will be fabricated using injection molded nano-hybrid     composite denture teeth. The wear of denture teeth will be evaluated using stereophotographic     recordings at baseline, 6, 12, 18 and 24 months after denture treatment.   "
160080|NCT01188213|"     The aim of this study was to determine the efficacy of methylsulfonylmethane (MSM) in     treating patients with knee OA.   "
160081|NCT01188200|"     The purpose of this study is to demonstrate the efficacy of a nutritional formula in patients     with type 2 diabetes.   "
160599|NCT01181414|"     The aim of the present study is to compare the response to cardiac resynchronization therapy     (CRT) in patients with chronic advanced heart failure and permanent atrial fibrillation (AF)     depending on atrio ventricular junction (AVJ) is ablated or not.   "
160085|NCT01188148|"     All participants should fulfill the following criteria: aged between 18 and 65 years old, and     of domestic Han descendants. Participants will be randomly assigned to either the (1)     pharmacotherapy (valproate add-on memantine) group; (2) pharmacotherapy (valproate add-on     memantine) plus Cognitive Behavior Group Therapy (CBGT) group; (3) valproate add-on placebo     plus CBGT group, or (4) valproate add-on placebo only group. A total of 240-320 individuals     (60-80 participants per group) will be recruited for this study. For each CBGT group,     12-weekly sessions are scheduled according to patients' preference. The investigators will     attempt to understand the effects of pharmaceutical drugs for mood stabilizers add-on     neuro-protective drugs, pharmacotherapy with CBGT, mood stabilizer with CBGT, and the use of     only traditional mood stabilizers in the treatment of BP II. Comparisons will be made for     each type of treatment and possible mechanisms will be examined regarding the pharmacotherapy     and CBGT for bipolar disorder patients.   "
160086|NCT01188135|"     Antidepressants are the most frequently prescribed class of psycho¬tropic medications and the     most common treatment for depression and anxiety disorders—yet patient adherence is poor and     is widely viewed as contributing to reduced effectiveness. However, traditionally-delivered     adherence promotion programs are complex, staff-intensive, and costly—barriers to wider     adoption, implementation, and maintenance of these programs in real-world settings. Our aim     is to carry out a trial of a low-cost, IT-enabled Antidepressants adherence program,     specifically a direct-to-patient, automated telephone interactive voice recognition (IVR)     intervention to boost patient Antidepressants persistence. We will conduct a randomized     clinical trial enrolling at least 6,000 Kaiser Permanente NW Region health plan members ages     21 to 75, who had recently started on Antidepressants medications for depression and/or     anxiety diagnoses. Participants will be randomized one of four arms;1. a no contact control     arm, 2. a treatment as usual (TAU) control condition 3. to TAU plus the IVR automated     telephone program and 4. a TAU plus the IVR automated telephone program plus receipt of     psycho-education materials about antidepression medication use. Recruitment will continue for     up to 18 months, with periodic participant-level follow-up assessment for the intervention     participants for 40 weeks. The IVR intervention portion of the program will deliver reminder     and/or tardy calls timed to projected Antidepressants refill dates. The intervention also     optionally offers brief psycho-education, or transfer to a live pharmacist or the Kaiser mail     refill pharmacy. The primary outcome will be the Estimated Level of Persistence with Therapy     (continued us of Antidepressants medications). This will be based on prescription refill data     abstracted from the Kaiser's electronic medical record (EMR). We hypothesize that     participants in the IVR + psycho-education materials study arm will have a significantly     higher rate of Antidepressants persistence than those in the TAU control condition ons only     IRV call arms. We will also conduct cost-effectiveness analyses to assess the value-for-money     (cost per depression free day gained, and cost per quality adjusted life year gained) of the     IVR technology compared to TAU. Costs will include IVR development and implementation as well     as EMR-derived healthcare utilization data (visits, medications, etc.), augmented with     participant report of out-of-plan services.   "
160087|NCT01188122|"     Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system intended     to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon dioxide (CO2)     in upper airways of mechanically ventilated patients. Optimal ETT cuff inflation will lead to     a reduction of complication rate related to mechanical ventilation procedure.      This study was design in order to evaluate the feasibility of using the AnapnoGuard system.   "
160088|NCT01188109|"     The purpose of this study is to investigate if the investigators can use a specific marker in     the pancreatic tumor itself to determine which patients will benefit from receiving     combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a     pancreatic cancer.      The investigators will also investigate if there is any benefit to receiving both     chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the     tumor.   "
160089|NCT01188096|"     This study is for patients up to 21 years of age who have a tumor called a low grade glioma     of the central nervous system (brain and spinal cord). The tumor has grown despite attempts     to control it with chemotherapy or radiation. Low grade gliomas are a group of tumors that     tend to grow slowly and could be cured if every bit of the tumor were surgically removed.     These tumors are called Grade I or II astrocytomas.      These tumors often grow in parts of the brain that prevent total removal without devastating     neurologic complications or death. Although some low grade gliomas never grow, most will and     are treated with either chemotherapy or radiation. There is good data showing that the growth     of most low grade gliomas can be controlled with chemotherapy or radiation. However, some low     grade gliomas in children and young adults grow despite these treatments. Poly-ICLC is a new     drug that has been used safely in children and adults with different types of brain tumors.     Earlier studies showed that this drug worked better for children and young adults with low     grade gliomas than for children with more aggressive brain tumors. The main purpose of this     study is to use Poly-ICLC treatment in a larger number of patients to see how well it works     and how many side effects occur.      As Poly-ICLC is not FDA approved, this study is authorized to use it under IND# 43984, held     by Oncovir.      Subjects will get injections of Poly-ICLC into muscle two times weekly. The first treatments     will be given in the clinic so allergic or other severe reactions, if any, can be monitored.     If subjects tolerate the injections and don't have a severe reaction, then the rest of the     injections will be given at home. Subjects/caregivers will be trained to give injections.      Treatment will last for about 2 years. Subjects may stay on treatment for longer than 2 years     if their tumor shrinks in response to the injections, if study doctors think it is safe, if     subjects want to remain on treatment, and if Poly-ICLC is available.      Risks: Poly-ICLC has been used safely in children and adults at the dose used in this study,     and at higher doses. Frequently seen side effects include irritation of the skin at the     injection site and mild flu-like symptoms. These are usually relieved or avoided by use of     over-the-counter medicines like acetaminophen (Tylenol).      Funding Source: FDA OOPD   "
160090|NCT01188083|"     Primary Objectives:        1. To determine whether a 4 week reduction in dietary fructose intake improves hepatic          steatosis in overweight children who have a baseline high fructose consumption and          hepatic steatosis.        2. To determine if a 4 week reduction of dietary fructose improves fasting plasma          triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as          well as post-prandial levels in response to a high fructose meal.        3. To determine if a 4 week reduction of dietary fructose improves markers of oxidative          stress.      Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose     beverages administered over 4 weeks.   "
160101|NCT01187940|"     When a clinician gives an autism spectrum disorder (ASD) diagnosis they hope this will be     helpful to the person receiving it and their family. In reality children with an ASD describe     few benefits to receiving this diagnosis - they often report feeling confused and stigmatised     by it. Parents can also struggle to understand their child's diagnosis and report needing     greater support from professionals in this respect (Midence & O'neill, 1999; Osborne & Reed,     2008).      Little is known about how to help children and families integrate their ASC 'label' in a     positive way. Whilst there is anecdotal evidence that psychoeducation after diagnosis can     help, there has been no formal evaluation of this approach and no evidence-based programmes     of this type are available. In the current study the investigators aim to test empirically a     psychoeducational programme for children with an ASD ('PEGASUS'), using a randomised     controlled design. The investigators aim to evaluate whether this psychological and     educational intervention impacts positively upon understanding of ASC, self-esteem,     functional adaption, well-being and family functioning.   "
160102|NCT01187927|"     This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in     Japanese female subjects under conditions of actual use.   "
160091|NCT01188070|"     More and more family members are providing care to their loved ones with prolonged and     progressive illnesses. Chronic intense caregiving represents a situation of chronic stress,     which takes a toll on one's mental and physical health including an increased risk for the     development or worsening of heart disease. Identification of effective self-care     interventions for family caregivers is warranted to improve their emotional wellbeing and     minimize the harmful effects of chronic stress on the heart. This Program Project Grant aims     to promote health and reduce cardiovascular risk in family caregivers (FCG) of persons with     chronic illness. In two studies the investigators will test two interventions,     psycho-education(ED) and physical exercise(EX), individually and in combination. The first     study will target FCG of African American dementia patients; the second will focus on FCG of     heart failure patients. Parallel designs, interventions and measures will create synergy as     will integration of all data management and analyses within a Bio-behavioral Science and     Measures Core. This Core will also provide high level guidance and interpretation of model     testing resulting from analysis of the common data set. The combined de-identified data set     will allow for elucidating the biological mechanisms of stress-induced cardiovascular risk,     further developing the model, and stimulating future research, while the shared core support     will provide substantial efficiency; neither could be achieved outside of a Program Project     approach. These collective efforts will generate important data whereby future care can     significantly enhance the lives of FCG and minimize their risk of cardiovascular disease, the     number one cause of disability and death in the United States.      We hypothesize that FCGs who receive the combined PSYCHED+EX intervention will have better     psychological functioning (lower levels of depressive symptoms, anxiety, and caregiver burden     and higher levels of flourishing), behavioral outcomes (improved sleep quality and greater     physical function), cardiovascular risk measures (improved resting heart rate, blood     pressure, heart rate recovery, oxygen consumption, lipids, glucose, and inflammatory     markers), neuroendocrine function (salivary cortisol) and overall health outcomes (improved     function, muscle strength, and endurance) compared to psycho-education and usual     care-attention control from baseline to six months later mediated by improvements in process     outcomes (lower perceived stress and higher self-efficacy).   "
160092|NCT01188057|"     This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam     Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2     mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs     Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult     volunteers administered under non-fasting conditions.   "
160093|NCT01188044|"     One way to assess impacts of nutrition supplements to health is to measure physical activity.     Physical activity can be measured with small devices called accelerometers. Before they can     be used, the devices need to be validated in the population in question. Objectives of this     study are to test accelerometers in field conditions and validate their use in 16-18 months     old Malawian toddlers. This study does not have a pre-set hypothesis.   "
160094|NCT01188031|"     This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam     Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2     mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs     Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult     volunteers administered under fasting conditions.   "
160095|NCT01188018|"     The purpose of this study is to determine, among a sample of general adult smokers, the     effectiveness of three different counseling interventions for motivating quit attempts among     smokers not yet ready to quit.   "
160096|NCT01188005|"     Obstructive Sleep Apnea Syndrome (OSAS) is associated with elevated plasma levels of IL-6 and     TNF-α, which cannot be accounted for by obesity (Vgontzas et al Sleep Med Rev 2005;9:211-24,     Ciftci et al Cytokine 2004;28:87-91].      Obstructive apneas-hypopneas are accompanied by strenuous diaphragmatic contractions before     the ensuing arousals and re-establishment of airway patency. We have shown that strenuous     diaphragmatic contractions induced by resistive loading lead to elevated plasma levels of     IL-6, TNF-α, and IL-1β (Vassi-lakopoulos et al AJRCCM 2002;166:1572-8) with concomitant     up-regulation of the cytokines within the diaphragmatic myofibers (Vassilakopoulos et al     AJRCCM 2004;170:154-61).      OSAS patients exhibit frequent episodes of hypoxemia during the night. Loaded breathing is a     form exercise for the respiratory muscles, and both acute and chronic hypoxia lead to an     augmented plasma IL-6 response to exercise compared to normoxia (Lundby et al Eur J Appl     Physiol 2004;91:88-93).      In OSAS, monocytes have oxidative stress (Dyugovskaya et al AJRCCM 2002;165:934-9) and     produce more cytokines (TNF-α) in vitro (Minoguchi et al Chest 204;126:1473-9).      Hypothesis #1: plasma levels of IL-6 and TNF-α are increased during the night in OSAS     patients secondary to the intermittent strenuous diaphragmatic contractions and the episodes     of hypoxia-reoxygenation associated with the obstructive apneas-hypopneas.      Hypothesis #2: monocytes from sleep apnea patients, exhibit augmented intracellular     expression of IL-6 and TNF-α during the night.      Hypothesis #3: Oxidative stress is a stimulus for cytokine upregulation in OSAS.   "
160097|NCT01187992|"     This study was designed to test the hypothesis that the addition of full-dose atorvastatin     (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after     non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse     coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.   "
160098|NCT01187979|"     The purpose of this study is to assess the impact of a cash-incentivised prevention     intervention on reducing HIV incidence rates in high-school learners in rural KwaZulu-Natal.   "
160099|NCT01187966|"     The purpose of this study is to evaluate the efficacy and safety of two doses of safinamide     (50 and 100 mg/day, p.o.), compared to placebo, as add-on therapy in patients with idiopathic     Parkinson's disease with motor fluctuations who are currently receiving a stable dose of     levodopa.   "
160100|NCT01187953|"     This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets     administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as     immunosuppression for the prevention of organ rejection in newly transplanted adult kidney     transplant recipients. Patients will be treated for a 12 month study period followed by a 12     month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically     similar to Prograf Capsules in the prevention of acute rejection.   "
160103|NCT01187914|"     The purpose of this study is to evaluate the impact of pre-ablation fibrosis on scar     formation in the left atrium of the heart. This will be assessed by delayed enhancement     magnetic resonance imaging and will be looked at in patients who have undergone successful     open irrigated cooled-tipped radio-frequency ablation of paroxysmal atrial fibrillation.     Follow-up after ablation will be for 12 months.   "
160104|NCT01187901|"     The purpose of this study is to determine in a randomized, placebo-controlled, phase II trial     if the combination of sulindac and erlotinib causes a significant regression of duodenal and     colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP (AFAP)     patients.   "
160113|NCT01187784|"     Many children and adolescents with autism spectrum disorder (ASD) experience high levels of     anxiety which can further inhibit their ability to master developmental tasks such as     succeeding in school and developing and maintaining friendships. Despite the need for     effective treatments for children with ASD and anxiety, there have been few studies that have     addressed this issue. Recently, preliminary evidence has supported the use of     cognitive-behavioral therapy (CBT) to treat anxiety disorders in children with ASD.      This study will utilize a CBT treatment program called Coping Cat. Coping Cat has been found     to be one of the most effective treatments for typically developing children with anxiety and     has also been shown to be effective for treating anxiety in children with other disorders     such as physical impairments, selective mutism, and Attention Deficit Hyperactivity Disorder.     The investigators goal is to demonstrate that Coping Cat is an effective treatment for     children with ASD and anxiety. Finding effective treatments for children with ASD and anxiety     could increase adaptive social relationships, decrease stress among families, and prevent the     maintenance of anxiety into adulthood.   "
160114|NCT01187771|"     The purpose of this study is to assess the feasibility of conducting a comparative     effectiveness study comparing a medical versus surgical approach to the initial management of     obstructive sleep apnea (OSA) in the setting of obesity.   "
160115|NCT01187758|"     This study aims to implement judicious antibiotic prescription habits to primary care     pediatricians using a multifacet educational intervention and assess two main outcomes: 1)     Direct outcome - prescription rates of the physicians. 2)Indirect outcome - carriage of     antibiotic resistant bacteria by the treated population, specifically nasopharyngeal S.     pneumoniae, nasal S. aureus and rectal E.coli.   "
160116|NCT01187745|"     Patients suspected of having a kidney stone are usually evaluated by computed tomography (CT)     scan. The investigators hypothesize that ultrasound (U/S) should be sufficient to evaluate     kidneys for suspected renal stones.   "
160117|NCT01187732|"     The purpose of this study is to compare the traditional bed bath with 'washing without water'     on        -  1) effects on skin integrity        -  2) patient and nurse satisfaction and 3) costs. In a cluster randomized trial we will          randomize 50 nursing home wards (576 patients) to 'washing without water' or traditional          bed baths. Bathing regimens are continued for six weeks.      Whereas effects on skin damage are not likely to be specific for setting, these results can     be generalized to other patient groups.   "
160118|NCT01187719|"     The primary objective of this two-phase trial is as follows:        -  To determine the elimination half-life of NVP in HIV positive pregnant women receiving          it as a single dose in labour in addition to the ZDV and 3TC with or without seven days          phenytoin (pilot PK phase)        -  To determine NVP resistance in HIV positive pregnant women receiving it as a single dose          in labour in addition to ZDV and 3TC with or without seven days phenytoin (main trial          phase)      The secondary objectives of this two-phase trial are as follows:        -  To determine the safety of single dose nevirapine with seven days phenytoin as a part of          ARV prophylaxis for PMTCT vs. single dose of nevirapine without phenytoin as a part of          ARV prophylaxis for PMTCT        -  To determine the HIV status of the infant        -  To determine the safety of the ARV prophylaxis for PMTCT with seven days of phenytoin on          the newborn      Hypothesis: phenytoin reduces the elimination half life of SD NVP and thereby decreases     development of resistance to NVP in HIV positive pregnant Tanzanian and Zambian women.   "
160119|NCT01187706|"     To compare quality of life and it's related factors between gynecological cancer survivor and     healthy controls.   "
160120|NCT01187693|"     People with anatomical leg length discrepancy (LLD) commonly presented excessive subtalar     pronation of the long leg compared to their short leg in order to equalize leg length.     Although such compensation may decrease the stress in the pelvis and/or low back region, the     pronated foot may lead to excessive stress loading onto the ankle or foot, resulting in     musculoskeletal injuries. Clinically, the pronated foot has been effectively controlled using     functional orthoses with proper posting by adjusting the subtalar joint in the neutral     position. But for people with compensatory pronated foot resulted from anatomical LLD, to     control excessive pronation of the long leg would exaggerate their asymmetry in leg length.     Instead, the pronated foot can be controlled simply by adjusting the length of the short leg.     However, there is limited evidence of such intervention in previous literature. The purpose     of this research project is going to determine the effect of leg length adjustment on     pronation control in people with anatomical LLD. According to this purpose, 5 study     objectives will be developed: 1) to examine the validity and reliability of LLD measurement     using a hand-held laser distance meter, 2) to compare the foot types before and after leg     length adjustment, 3) to compare the kinetic variables before and after leg length adjustment     during quiet stance, 4) to compare the kinetic variables before and after leg length     adjustment during level walking, and 5) to compare symptoms and functional levels related to     low back pain (LBP) before and after leg length adjustment.      The present research project will be designed as a convenience sampling, prospective,     quasi-experimental, and pretest/posttest design. There will be 2 parts in this research: 1)     validity and reliability test of laser measure for leg length and 2) foot morphology and     kinetic analysis before and after leg length adjustment. For the first part of this research,     10 male adults and 20 adults will be recruited for the validity and reliability tests     respectively. Anthropometric measurements, including body height, body weight, foot length,     foot width, and heel-ball distance, will be measured after a consent form is signed.     Participants of the validity test will receive standing pelvic radiography and laser measure     to measure their leg length. Each participant of the reliability test will receive 2 sessions     of laser measure using a hand-held laser-distance meter. For the first session, all laser     measurements will be employed twice by 2 raters with a rest interval of more than 5 min. One     week later, another session of laser measure will be given again by one of these 2 raters.     Intraclass correlation coefficient (ICC) will be used to test the interrater reliability,     intrarater reliability, and validity of the laser measure method. Standard error of     measurement (SEM), and small real difference (SRD) will be calculated to represented     intrarater reliability also. For the second part of the research, another thirty adults with     compensatory pronated foot resulted from LLD will be included in the research project but the     sample size will be adjusted to the appropriate number according to power analysis. Each     participant will be asked to fill out the visual analog scale (VAS) and the Oswestry     Disability Index (ODI) and receive tests containing foot type examination, quiet stance with     eye opening, quiet stance with eye closed, and level walking. All tests will be performed     before and after leg length adjustment. The experiment will be completed after collecting 3     successful trials for each test. All procedures will be done one month later. ANOVA with     repeated measures will be calculated to compare the differences in these variables among     before, immediately after, and 1 month following leg length adjustment when the data fit the     assumptions of normal distribution. Discrete variables or variables with non-normal     distribution were tested using the Friedman test. All statistical analyses will be calculated     using SAS 9.1.3. The significant level was set at α = 0.05 while the power was at 0.8.      Five possible results may be expected from conducting this research project: 1) there will be     good validity and reliability of the laser distance meter to measure LLD, 2) there will be     significant differences in measurements of foot type before and after leg length adjustment,     3) there will be significant differences in kinetic data during quiet stance before and after     leg length adjustment, 4) there will be significant differences in kinetic data during level     walking before and after leg length adjustment, and 5) symptom and functional level related     to LBP will improve after leg length adjustment. Completion of this research project will be     projected to provide solid and objective evidences for leg length adjustment through views of     morphology and kinetics in people with pronated foot due to anatomical LLD.   "
160121|NCT01187680|"     The purpose of the study is to investigate whether sprayable PEG barrier is effective in     reducing adhesions in laparoscopic gynecologic surgery.   "
160122|NCT01187667|"     Haloperidol is prescribed in high risk ICU patients concerning delirium (50% or more chance     to develop delirium detected with the delirium prediction model PRE-DELIRIC, or patients with     history of dementia or alcohol abuse)since the delirium protocol is changed and haloperidol     is added as a prevention treatment we are gathering information what the effect is on several     aspects of delirium   "
160147|NCT01187342|"     Neuro-psychological, cognitive and biochemical assessment matched with MR-Imaging in acute     and chronic poststroke conditions.   "
160123|NCT01187654|"     Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery     and restore blood flow to the heart muscle after myocardial infarction, there may be a     significant amount of heart tissue that has been irreversibly damaged. Recent studies have     shown that adult stem cells from bone marrow may be able to improve heart function and     prevent from heart remodeling due to heart failure.      This study will evaluate the safety and effectiveness of using adult bone marrow derived stem     cells for improving heart function in MI patients with Left Anterior Descending (LAD)     involvement.   "
160124|NCT01187641|"     The purpose of this study is to determine whether MRI is more accurate than CT in determining     the T stage, N stage, depth of tumour invasion and extra mural venous invasion (EMVI)     preoperatively in colon cancer.   "
160125|NCT01187628|"     The objective of this study is to investigate the safety and the effect on reduction of serum     phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in     patients with hyperphosphatemia who completed the 8 week double-blind treatment period of     Study 14817 and are judged to be eligible for the long-term extension study.   "
160126|NCT01187615|"     This is a multi-center, open-label, non-randomized Phase I study to define the safety     profile, maximum tolerated dose (MTD) and potential pharmacokinetic interaction of     regorafenib in combination with pemetrexed and cisplatin in patients with Stage IIIB or Stage     IV nonsquamous Non-Small Cell Lung Cancer (NSCLC) and to determine the impact of the combined     administration on the pharmacokinetics of regorafenib, pemetrexed, and cisplatin.      In Part A of this trial, regorafenib will be administered in a sequential dosing with a seven     day wash out period before the next infusion of pemetrexed and cisplatin. Regorafenib will be     administered at a dose of 160 mg qd from Day 2 to Day 14 followed by a 7 days break.      In Part B of this trial, regorafenib will be administered continuously from Day 1 to Day 21.     Only in Cycle 1, regorafenib dosing will start on Day 2 in order to assess the     pharmacokinetics of pemetrexed and cisplatin without concomitant regorafenib dosing.   "
160127|NCT01187602|"     The purpose of this study is to create new tests to identify biomarkers for ovarian cancer so     that a screening test can be developed. For patients who have a diagnosis of ovarian Cancer,     researchers will use blood samples before and after treatment to see if disease status can be     determined by measuring the amount of biomarker.   "
160128|NCT01187589|"     This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of     Aerosol and on Pulmonary Functions in COPD Patients   "
160129|NCT01187576|"     Background The present study protocol describes the trial design of a primary care     intervention cohort study, which examines whether an extended, multi-professional physical     activity referral (PAR) intervention is more effective in enhancing and maintaining     self-reported physical activity than ordinary physical activity recommendations. The study     targets patients with newly diagnosed hypertension and/or type 2 diabetes.      Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose;     physical fitness and anthropometric variables; mental health; health related quality of life;     and cost-effectiveness. Methods/Design The study is designed as a long-term intervention.     Three primary care centres are involved in the study, each constituting one of three     treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR,     lifestyle brochure; 2) Control group A (CA): ordinary recommendations on health behaviours,     lifestyle brochure; and 3) Control group B: treatment as usual (retrospective data     collection).      The intervention is based on self-determination theory and follows the principles of     motivational interviewing. Physical activity is measured with the International Physical     Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per     week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as     health behaviours; health-related quality of life; motivation to change; mental health;     demographics and socioeconomic characteristics are assessed with an electronic study     questionnaire that submits all data to a patient database, which automatically provides     instant feed-back on the patients' health status.      Cost-effectiveness of the intervention is evaluated continuously and the intermediate      - 3 - outcomes of the intervention are extrapolated by economic modelling. The first     statistical analyses and compilation of results will be performed one year after inclusion of     the first patient or when the IG and CA have included 60 and 30 eligible patients     respectively. Discussion By helping patients to overcome practical, social and cultural     obstacles and increase their internal motivation for physical activity we aim to improve     their physical health in a long-term perspective. The targeted patients belong to a patient     category that is supposed to benefit from increased physical activity in terms of improved     physiological values, mental status and quality of life, decreased risk of complications and     maybe a decreased need of medication.   "
160130|NCT01187563|"     This is an open-label, uncontrolled, observational study in patients with rheumatoid     arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their     standard of care.   "
160131|NCT01187550|"     This is an open-label, prospective, multicentric, non-comparative, non-randomized Phase IV     interventional study in which subjects pre-diagnosed with Growth Hormone Deficiency (GHD)     were treated for 4 weeks with Saizen to compare the response between GHD children born     appropriate for gestational age (AGA) and those born small for gestation age (SGA) after 4     weeks of Saizen therapy.   "
160132|NCT01187537|"     The purpose of this study is to compare the effectiveness of three analgesia techniques on     pain relief and functional recovery after knee replacement: continuous femoral nerve block vs     single-injection femoral nerve block with intravenous patient controlled analgesia vs     intravenous patient controlled analgesia.   "
160133|NCT01187524|"     Background:        -  In human DNA, the Fragile X (FMR1) gene helps to regulate the nervous and reproductive          systems. If the gene is abnormal, it can cause different kinds of problems, such as          abnormal menstrual periods, decreased fertility, muscle tremors, and mental retardation.          An abnormal FMR1 gene can also make a person more susceptible to other medical          conditions, such as thyroid problems, high blood pressure, seizures, and depression.          More research is needed on how abnormalities in the FMR1 gene can lead to these          problems, and how often these problems appear in individuals with an abnormal FMR1 gene.        -  Researchers are interested in developing a patient registry of women who have an          abnormality in the FMR1 gene. This registry will allow researchers to follow          participants over time and study possible effects of this abnormality on their general          and reproductive health.      Objectives:      - To develop a patient registry of women with an abnormal FMR1 gene and monitor their general     and reproductive health.      Eligibility:      - Women at least 18 years of age who have an abnormal FMR1 gene on the X chromosome.      Design:        -  The following groups of women will be eligible for screening for this study:        -  Those who have a family member with Fragile X Syndrome or mental retardation        -  Those who have (or have a family member who has) primary ovarian insufficiency, also          known as premature menopause        -  Those who have (or have a family member who has) certain neurological problems such as          tremors or Parkinson's disease.        -  Eligible participants will be scheduled for an initial study visit at the National          Institutes of Health Clinical Center. Participants who have regular menstrual periods          should schedule the visit between days 3 and 8 of the menstrual cycle; those who do not          have regular periods may have the visit at any time of the month. In addition, all          estrogen-based treatments (such as birth control pills) must be stopped for 2 weeks          prior to the study visit.        -  Participants will have a full physical examination, provide a medical history, and          provide blood samples for immediate and future testing. Participants will return for          yearly visits for the same tests for as long as the study continues.        -  Participants who have or develop primary ovarian insufficiency related to the FMR1 gene          will also have tests to measure bone thickness and will have a vaginal ultrasound to          examine the ovaries. These tests will be scheduled for a separate visit, and will be          repeated every 5 years for the duration of the study.   "
160148|NCT01187329|"     The overall research plan is to test the hypothesis that intraoperative treatment of     hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial     function and short-term outcomes compared with standard glucose management.   "
160134|NCT01187511|"     Objective:      To evaluate GSK561679, an orally available, brain penetrant selective CRH1 antagonist for its     ability to reduce alcohol craving in recently detoxified alcohol dependent women in response     to stress or alcohol-associated stimuli.      Study population:      Up to 60 anxious, alcohol dependent women, aged 21-65 years will be enrolled to complete the     study in 50 patients.      Background:        -  Anxiety, irritability, anger, and depression can all cause stress that may lead to          continued drinking in heavy drinkers. One way the brain responds to stress is through a          protein on brain cells called a CRH receptor. Previous research has shown that the CRH          receptor is involved in negative emotional states and that chronic alcohol consumption          increases the activity of CRH receptors in the brain. Medications that block CRH          receptors can decrease stress-triggered alcohol consumption.        -  GSK561679, an experimental drug that blocks the CRH receptors, can reduce negative          emotions such as anxiety and a person s desire for alcohol. By looking at the brain s          response to stress and the study drug using functional magnetic resonance imaging (fMRI)          scans, researchers hope to learn whether GSK561679 can be an effective treatment for          stress-related alcohol abuse.      Objectives:      - To evaluate the usefulness of GSK561679 in reducing stress-related alcohol craving in     alcohol-dependent women.      Design:        -  Participants in the study will be enrolled in the standard NIH treatment program for          alcohol dependence, and will be required to stay at the NIH inpatient treatment unit for          an additional 31 days.        -  Participants will receive either the study medication or a placebo to be taken once a          day in the evening for 4 weeks.        -  Participants will have the following procedures while on the study medication:        -  Questionnaires about alcohol craving, depression, and anxiety.        -  Recordings and responses to personal emotional reactions to stressful, nonstressful, and          alcohol-related situations, with blood samples taken during the responses.        -  Regular blood tests to measure stress hormones in the blood.        -  Speech preparation and presentation (Trier test), along with blood samples, to measure          stress hormones in the blood.        -  Sessions to measure responses to alcohol-related cues.        -  Functional magnetic resonance imaging (fMRI) scans.        -  Participants will return for follow-up visits 1 week and 1 month after stopping the          study drug and being discharged from the study.   "
160135|NCT01187498|"     The primary purpose of this project is to evaluate the effectiveness of behavioral treatment     compared to standard drug therapy for symptoms of OAB in male veterans.   "
160136|NCT01187485|"     The purpose of this study is to see how safe Androderm® (the study drug) is at three     different doses in subjects with early hormone refractory prostate cancer. In addition,     information about hormonal levels and the effects of testosterone on quality of life     including sexual functioning and muscle strength will be collected.   "
160429|NCT01183650|"     The purpose of this study is to investigate the pharmacokinetics of tadalafil in Japanese and     non-Japanese men with Benign Prostatic Hyperplasia (BPH).      The safety of tadalafil will also be studied.   "
160137|NCT01187472|"     This protocol was opened to collect long term survival information on subjects enrolled in a     previous study which evaluated the impact of neoadjuvant chemotherapy and concomitant     chemoradiotherapy with organ preserving optional surgery on overall survival, time to     progression, pattern of disease recurrence in patient with locally advanced head and neck     cancer. The last surviving subject was last treated in 1989, and was lost to follow up in     2010.   "
160138|NCT01187459|"     Background: Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), is a chronic     relapsing inflammatory disorder of the digestive system. CD affects ~112,000 individuals in     Canada, of whom 20-25% are diagnosed in childhood or adolescence. The specific cause of CD     remains unknown; however, it is hypothesized that CD involves a complex interaction of     several factors, including a genetically susceptible host, the intestinal mucosal immune     system and microbe population. Several dietary factors have been explored for their potential     role in the etiology of CD. However, no consensus on the role of diet has emerged. Recent     evidence suggests a plausible link between a lack of Vitamin D and CD.      Purpose & Hypothesis: The investigators primary hypothesis is that a greater proportion of     pediatric CD patients will achieve optimal 25OHD concentration (> 75 nmol/L) on 2000 IU/d     than 400 IU/d Vitamin D.      Methods: Pediatric Crohn's Disease patients between 8-18 years of age, and have been in     remission for at least 4 weeks as indicated by a Pediatric Crohn's Disease Activity Index     (PCDAI) <10 will be recruited for a double-blind, randomized, controlled trial where they     will receive one of two dosages of vitamin D (10 or 50 ug/day) and will be asked to continue     the supplementation for 6 months. Vitamin D levels will be measured in blood at baseline, 3     months, and 6 months. Dietary vitamin D intake will be estimated using a food frequency and     lifestyle questionnaire. Data will be analyzed using multiple regression analysis controlling     for baseline values.      Expected Results and Conclusions: It is expected that a greater proportion of children     receiving the 50 ug/day vitamin D supplement will achieve a blood vitamin level >75 nmol/L     compared to children receiving 10 ug/day. This data will aid policy makers, parents/children     and healthcare workers in recommending an appropriate vitamin D dosage for the pediatric     crohn's population.   "
160139|NCT01187446|"     The purpose of this study is to determine if vorinostat combined with low-dose total skin     electron beam therapy (TSEBT) offers superior clinical benefit (efficacy & safety) over     low-dose TSEBT alone.   "
160140|NCT01187433|"     The purpose of this study is to generate immunogenicity and safety data in preparation for     efficacy studies in Latin America.      Primary Objectives:        -  To describe the immune response to dengue viruses before and after each vaccination with          CYD dengue vaccine.        -  To evaluate the safety of each vaccination with CYD dengue vaccine.   "
160141|NCT01187420|"     The purpose of this study is to assess real time changes in raw and processed EEG in relation     to the clinical and radiological evidence of cerebral vasospasm.   "
160142|NCT01187407|"     The purpose of this study is to assess if LY2216684 (fixed 6 mg or flexible 12 mg to 18 mg     once daily) is superior to placebo once daily in the adjunctive treatment of participants     with major depressive disorder (MDD) who were identified as partial responders to an adequate     course of treatment with a selective serotonin reuptake inhibitor (SSRI), during an 11-week,     double-blind, acute adjunctive treatment phase.   "
160143|NCT01187394|"     In Canada, 218,000 units of fresh frozen plasma and frozen plasma were transfused in     2005.Cardiac surgery patients are the largest recipient group for FP transfusions. Despite     this, no studies have characterized the use of FP in relation to coagulation test     abnormalities or bleeding, or how these and other clinical determinants influence the     decision to transfuse FP. Furthermore, no studies have evaluated the effectiveness of FP     transfusions in correcting laboratory abnormalities or treating bleeding in cardiac surgery.      Given the varied use of FP transfusions in cardiac surgery, further studies are essential.In     order to improve current utilization of FP, current use must be understood, and the     relationship between FP transfusions and the clinical factors that affect the decision to     transfuse FP.   "
160144|NCT01187381|"     This single arm observational study will assess the duration and safety of treatment with     Herceptin (trastuzumab) in routine clinical practice in patients with early or metastatic     HER2-positive breast cancer. Data will be collected from female patients treated with     Herceptin according to the Summary of Product Characteristics and local protocols. Duration     of observation for each patient is from therapy initiation until permanent discontinuation     for any cause.   "
160145|NCT01187368|"     The objective of this pivotal study is to assess the safety and efficacy of the EVAHEART LVAS     as a bridge-to-transplant for subjects with end stage heart failure. Subjects will be     followed for 180 days after the EVAHEART LVAS implant or until cardiac transplant or explant     for recovery (+ 60 days or discharge). If after 180 days post-implant the subject has not     received a cardiac transplant or the device has not been explanted, the subject will continue     to be followed monthly.   "
160146|NCT01187355|"     The purpose of this study is to compare two contact lens care solutions in symptomatic     wearers of silicone hydrogel contact lenses.   "
160149|NCT01187316|"     The aim of the present study was to carry out a pilot project comparing the effectiveness of     two therapeutic approaches to temporomandibular disorders (TMDs) in adolescents. Eight female     individuals diagnosed based on the Research Diagnosis Criteria for TMDs (RDC/TMD-axis 1)were     randomly divided into two groups: 1) Massage therapy and muscle stretching (n=4); and 2)     transcutaneous electrical nerve stimulation (TENS) (n=4). Regardless the treatment, ten     sessions were held for each patient and two measurements (baseline and 10th session) were     performed for the assessment of symptom evolution using a visual analog scale (VAS), maximum     opening of the mouth (MOM) and pressure pain threshold (PPT). Statistical analysis wiil be     carefully selected.   "
160150|NCT01187303|"     The purpose of this trial is to determine the efficacy of ofatumumab in patients with     relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).   "
160151|NCT01187290|"     The main objective of this trial is to compare feasibility and efficacy of sequential     neoadjuvant chemoradiotherapy with 44Gy concomitant boost to neoadjuvant chemotherapy alone.     Secondary objectives are to assess the value of position emission tomography (PET）in     predicting pathological response and event-free survival（EFS）in stage IIIA non-small cell     lung cancer (NSCLC). Further to compare the amount of serum DNA in patients with stage IIIa     NSCLC before, during and after chemotherapy, before and after radiotherapy (in arm A) and     during follow-up in patients randomized into the trial and to correlate the Deoxyribonucleic     acid (DNA) variation with tumor response, remission duration and overall survival.   "
160275|NCT01185678|"     Adherence to the dosing scheme is the principal element of COC efficiency. On the other hand     noncompliance seemed to be an inseparable element of any oral treatment. The aim of the study     is to evaluate in everyday practice the relation between dosage errors and indicated factors,     potentially influencing the compliance with the dosing scheme.   "
160152|NCT01187277|"     The incidence of stroke in the industrial world is still high. Most of the patients are     suffering from paresis of the affected side, speech and cognition problems. Modern concepts     of motor learning after stroke favouring a task-specific repetitive high-intensity therapy     approach to promote motor outcome. In the last couple of years robot-assisted therapy became     an important part of modern rehabilitation after stroke. But so far there is no clear     evidence that robot assisted therapy in combination with conventional therapy is more     effective than conventional therapy alone to promote motor functions after stroke.   "
160153|NCT01187264|"     In this study the investigators intend to compare the efficacy and safety of two fixed doses     of once weekly oral methotrexate in a prospective randomized double blind manner in patients     with severe plaque type psoriasis.   "
160154|NCT01187251|"     The aim of this study is to compare the incidence of tinnitus between mp3 users and     non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença     secondary schools. High frequency audiometry and otoacoustic emissions will be     performed.Tinnitus patients will complete the Tinnitus Handicap Inventory questionnaire.   "
160155|NCT01187238|"     The purpose of this study is to verify the role of adding cisplatin chemotherapy to the     intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.   "
160156|NCT01187225|"     The purpose of this study is to evaluate prospectively whether concentrate fibrinogen reduces     blood losses, transfusion requirements and occurrence of clinical complications compared to     cryoprecipitate in children after cardiac surgery with pump.   "
160157|NCT01187212|"     This study investigates the efficacy and safety profiles of sorafenib in combination of     capecitabine and cisplatin, one of standard chemotherapy regimens in patients with advanced     gastric cancer.   "
160158|NCT01187199|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of bevacizumab (Avastin) and temsirolimus (Torisel) that can be given with 1 of 3     other study drugs --carboplatin (Paraplatin), paclitaxel (Taxol), or sorafenib (Nexavar). The     safety of these drug combinations will also be studied.   "
160159|NCT01187186|"     The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral     administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with     normal hepatic function based on the Child-Pugh Classification (CPC).   "
160160|NCT01187173|"     Goal:      The primary goal of this study is to longitudinally investigate, in head and neck cancer     (HNC) patients, the potential fibrosis-lymphedema continuum. Specifically, we will examine     the development, patterns, progression, and prevalence of late-effect fibrosis and/or     lymphedema, explore potential biological correlatives including pro-inflammatory cytokines     and genetic polymorphisms, and evaluate the relationship among late-effect fibrosis and/or     lymphedema and select psychosocial stressors that potentially interact with cytokine     pathways.      H: A minimum of 20 percent of HNC patients will experience late-effect fibrosis and/or     lymphedema.      H: We will be able to differentiate characteristics patterns of the development of     late-effect fibrosis and/or lymphedema.      H: We will be able to differentiate patterns of symptoms associated with late-effect fibrosis     and/or lymphedema.      H: We will be able to differentiate patterns of inflammatory response and the development of     late-effect fibrosis and/or lymphedema.      H: Select polymorphisms will increase the likelihood of development of late-effect fibrosis     and/or lymphedema.      H: Incidence and severity of late-effect fibrosis and/or lymphedema will correlate with total     dose of radiation to involved anatomical site.      H: HNC patients with fibrosis and/or lymphedema experience greater levels of depression and     social withdrawal than those without these conditions.   "
160161|NCT01187160|"     The purpose of this study is to assess if the da Vinci® Robotic Surgical System (Intuitive     Surgical, Inc., Sunnyvale, CA) allows for adequate exposure for transoral resection of     hypertrophic lingual tonsils in patients with obstructive sleep apnea.   "
160190|NCT01186783|"     MODIfY is a prospective, single center, open label, randomized, controlled two arms, Phase     II-trial to evaluate the ability of ivabradine to reduce an elevated heart rate in Multiple     Organ Dysfunction Syndrome (MODS) patients. The primary end point is the proportion of     patients with a reduction of heart rate by at least 10 beats per minute (bpm) within 4 days.     This trial will randomize 70 patients (men and women, aged ≥ 18 years) with newly diagnosed     MODS (Acute Physiology and Chronic Health Evaluation (APACHE) II-score ≥ 20, diagnosis within     ≤ 24 hours), with an elevated heart rate (sinus rhythm with HR ≥ 90 bpm) and     contraindications to beta-blockers (BBs). Treatment period will last 4 days. All patients     will be followed for up to six months.   "
160191|NCT01186770|"     MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind,     placebo-controlled, parallel-group study in order to evaluate the safety and efficacy of oral     MNTX for the treatment of opioid induced constipation in subjects with chronic, non-malignant     pain.   "
160162|NCT01187147|"     Asthma is a disease characterized by chronic inflammation in the airways. Recent research has     demonstrated that one of the reasons for the chronic inflammatory state is an imbalance     between oxidative stress and antioxidative defenses in patients with asthma.      Green tea is a common beverage consumed by Chinese patients from all walks of life. Green tea     contains chemical components that are thought to have immunomodulatory actions in chronic     inflammation.      The investigators propose to recruit 35 patients with stable asthma. Recruited subject will     be given oral tablets containing Green tea extract (GTE) to be taken daily for three months.     Clinical follow up and assessment will be done at baseline, on completion of GTE intake at     three months, and at three months after GTE intake has been stopped. A questionnaire on their     health status and the frequency of symptoms and use of bronchodilators and inhaled steroids     will be completed, spirometry will be done and a venous blood sample will be taken during     recruitment and during each reassessment at 3 and 6 months. Measurement of     oxidants/antioxidants (GSH, GSSG, SOD, CAT and GPx) will be carried out on the blood samples.     Oxidants/antioxidants will be compared and correlated with lung function results.      This study would provide us with pilot data as to whether GTE, a strong antioxidant with     immunomodulatory actions, has any effect on reducing the oxidative stress and improving the     antioxidant status in patients with asthma and whether these changes are accompanied     improvement in clinical status.      Hypothesis Green tea extract (GTE) reduces oxidative stress and improves antioxidant defenses     in Chinese patients with asthma   "
160163|NCT01187134|"     Patients with severe sepsis or septic shock suffer from life-threatening infections. Fast and     adequate therapy with antibiotics is crucial for survival. Current guidelines recommend the     application of broad-spectrum antibiotics within 1 hour after diagnosis. However, recent     studies showed that such treatment is delayed for several hours.      In this study, medical staff of participating hospitals is trained to achieve a duration     until antimicrobial therapy of less than 1 hour. Tools of change management are used. The     data are compared to a control group (hospitals without intervention).      It is hypothesized that a multifaceted educational program decreases duration until     antimicrobial therapy and improves survival.   "
160164|NCT01187121|"     The objective of this three year project funded by the National Institute of Justice is to     conduct a program evaluation of the Decide Your Time program at the Hares Corner Office of     the Delaware Department of Probation and Parole. The program is intended to provide an     alternative to incarceration by monitoring chronic drug offenders through increased,     regularly scheduled, known urinalysis testing, coupled with increasing sanctions and referral     to treatment for positive tests. The program was designed and is being implemented by the     Delaware Department of Probation and Parole. Offenders will become eligible for the program     when they test positive for drugs at their initial probation intake at the Hare's Corner     Probation Office in New Castle, Delaware or are moved from standard probation to intensive     supervision due to failed urine tests. Due to budgetary constraints, the office lacks     sufficient resources to place all eligible offenders into the program. The Department of     Probation thus intends to randomly assign eligible offenders to either intensive supervision     probation (ISP)(n=400) or the Decide Your Time program(n=400). Those in ISP will receive the     normal intensive supervision requirements, including weekly visits and random urinalysis.     Those in the enhanced condition will receive regularly scheduled urinalysis coupled with     referral to treatment, if required, and a program of graduated sanctions. The Center for Drug     and Alcohol Studies is conducting an evaluation of the program that involves examining data     on effectiveness, and collecting and examining data on program implementation, and probation     officer and client perspectives of how the program worked. It is hypothesized that those     randomized to the Decide Your Time program will have fewer arrests, violations and positive     urine screens upon program completion than those randomized to the control condition.   "
160165|NCT01187108|"     Chronic mountain sickness is characterized by excessive red blood cell production which     causes sludging of the vascular system. This high viscosity blood causes heart failure,     cognitive dysfunction, and strokes. The investigators hypothesize that cobalt which has been     previously been shown to be an environmental pollutant worsens the overproduction of red     blood cells. The investigators plan to conduct a 6 week trial in which acetazolamide (already     shown to improve chronic mountain sickness) and N-acetylcysteine (a drug that removes cobalt     from the blood) are evaluated in their potential to improve chronic mountain sickness.   "
160166|NCT01187095|"     Many couples experience involuntary childlessness and seek treatment at fertility clinics.     Going through treatment procedures can be very challenging, time consuming and emotionally     demanding.      Psychosocial intervention might have a soothing and healing effect on both behavior as well     on physical matters. Hence, the investigators would like to investigate whether Expressive     Writing Intervention (EWI) has an effect on stress management as well as on the pregnancy     rate for couples who are going through fertility treatment.   "
160167|NCT01187082|"     Hypothesis:the effect of bladdertraining in groups for patients with OAB (overactive bladder     syndrome) equals the effect of bladdertraining individually for patients with overactive     bladder.      The effect of the training is measured in a 3 dimensional scope by the means of 3 primary     outcome measures used in the statistical evaluation. Symptoms of OAB (either     (1)urgencyepisodes or (2)urgencyincontinence) and (3)quality of life (VAS score).   "
160168|NCT01187069|"     A huge challenge in type 2-diabetes care is how to motivate patients towards health behaviour     changes. In Denmark, the tendency is that nurses in general practice provide a large part of     type 2 diabetes care.      Observational studies support Self-determination Theory by finding autonomous motivation and     perceived competence associated with improved HbA1c-levels in patients with type 2 diabetes.     Hence, research is needed to develop and test interventions that are autonomy supportive.      Aim To develop a training course for practice-nurses in autonomy support in patients with     type 2 diabetes, and to evaluate the effect on patient outcomes.      Methods The development of the intervention was based on literature research and expert     meetings. The intervention is evaluated in a cluster randomised controlled trial with 40     Danish general practices,        -  where nurses, before enrolment in the study, provided consultations to patients with          type 2 diabetes,        -  and about 2500 patients with type 2 diabetes, identified in a Diabetes Database.      The patients will be followed 15 months from nurse-participation in the course. Data will be     obtained from registers and patient-questionnaires. The hypothesis is that patients with type     2 diabetes regardless of education level, age, and gender will benefit from the intervention.   "
160192|NCT01186757|"     Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers   "
160230|NCT01186263|"     The purpose of this study is to assess the predictive value of 99mTechnetium (Tc)- labeled     albumin in macroaggregates (MAA) and in microspheres (B20) injected into the common hepatic     artery for the distribution of 90Yttrium- Selective Internal Radiotherapy (SIRT)-spheres     (SIR- spheres).   "
160976|NCT00000549|"     To determine if estrogen replacement therapy, with or without low dose progesterone, slows     progression or induces regression of coronary atherosclerosis in postmenopausal women.   "
160169|NCT01187056|"     General practitioners (GPs) and patients find it difficult to talk about risk of future     disease, especially when patients have asymptomatic conditions, and treatment options are     unlikely to cause immediate perceptible improvements in well-being. Further studies in risk     communication for disease prevention are needed, as are studies about risk communication     training for GPs. Aim: 1) to systematically develop, describe and evaluate a complex     intervention comprising a training programme for GPs in risk communication and shared     decision-making, 2) to evaluate the effect of the training programme on real-life     consultations between GPs and patients with high cholesterol levels, and 3) to evaluate     patients' reactions during and after the consultations. Hypothesis: 1) patients have better     adherence to chosen treatment.      The effect of the complex intervention, based around a training programme, will be evaluated     in a cluster-randomised controlled trial with an intervention group and an active control     group with 40 GPs and 280 patients in each group.      The GPs receive a questionnaire at baseline and after 6 months about their attitudes towards     risk communication and cholesterol-reducing medication. After each consultation with a     participating high cholesterol-patient, the GPs will complete a questionnaire about decision     satisfaction.      The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes     questions about adherence to chosen treatment, self-rated health, patient enablement, and     risk communication and decision-making effectiveness. Prescriptions, contacts to the health     services, and cholesterol level will be drawn from the register of the National Health     Service of Denmark at baseline and at 6 months.      In both intervention group and active control group, 12 consultations will be observed and     tape-recorded. The consultations will be divided between 4 GPs with each 3 patients. The     patients from these 24 consultations will be interviewed immediately after the consultation     and re-interviewed after 6 months.Eight purposefully selected GPs from the intervention group     will be interviewed in a focus group 6 months after participation in the training programme.     The process and context of the RISAP-study will be investigated in detail using an action     research approach, in order to describe and analyse research choices, adaptation of     intervention model to the specific context, and GPs' and patients' reactions to trial     participation.   "
160170|NCT01187043|"     The purpose of this study is to determine the effects of five different doses of Proellex on     menses, ovulation, liver function, and steady state exposure in women of reproductive age.   "
160171|NCT01187030|"     There is little evidence to guide the current use of Frozen Plasma. Despite this, over     260,000 units of frozen plasma are transfused in Canada annually. Based on the limited     published data available, the pattern of practice for Frozen Plasma transfusions is highly     variable and an important number of Frozen Plasma transfusions appear to be inappropriate.     Given inappropriate use, it is inevitable that a percentage of patients experience     unnecessary and potentially life-threatening adverse transfusion reactions. Current     guidelines for Frozen Plasma offer little help in guiding specific clinical decisions as     their recommendations lack sufficient clinical details. This lack of detail also hinders the     utility of these guidelines to help monitor and improve clinical practice. Further research     examining Frozen Plasma transfusions including an understanding our current use is critical     to improve the utilization of this valuable and limited resource.   "
160172|NCT01187017|"     Background:        -  Severe aplastic anemia (SAA) can lead to problems with bone marrow health and result in          low blood cell counts, which require frequent transfusions. Standard initial treatment          for SAA involves injections of antithymocyte globulin (ATG) plus cyclosporine (CsA).          Patients with SAA who do not respond to initial treatment with ATG (refractory) have a          high risk of dying without additional treatment. In these cases, for those who do not          have a matched bone marrow transplant donor there is no well-defined standard therapy.          In our experience with patients who do not respond to horse ATG + CsA, only about          one-third of patients who are re-treated with rabbit ATG + CsA improve. Experience with          cyclophosphamide in the treatment of refractory severe aplastic anemia suggests that          this drug is able to improve blood counts in about 50% of cases. However, the          cyclophosphamide regimen has been associated with a significant infection risk (mostly          caused by fungus) in studies conducted over 10 years ago due to the lowering of the          white blood cell levels.        -  Better antibiotic drugs against fungus have been developed and are widely used to treat          patients who have low white blood cell counts and are at risk of developing infections.          In SAA patients in particular, these newer antibiotics have had a large impact in          preventing and treating fungus infections. Researchers are revisiting the use of          cyclophosphamide at lower doses to minimize its side effects given in combination with          another immune suppressant, fludarabine.      Objectives:      - To determine the safety and effectiveness of the combination of fludarabine plus     cyclophosphamide in treating severe aplastic anemia that has not responded to initial     treatments.   "
160173|NCT01187004|"     Hypothesis of the study is that patients undergoing major cardiac surgery can develop     extracardiac complications correlated to cardiopulmonary by pass.   "
160174|NCT01186991|"     This is a randomized, Phase II, double-blind, multicenter, placebo-controlled trial designed     to preliminarily estimate the efficacy and evaluate the safety and tolerability of     onartuzumab (MetMAb) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel versus     placebo + bevacizumab + paclitaxel in participants with metastatic or locally recurrent,     triple-negative breast cancer who either have not received treatment (first-line) or have     progressed after one conventional cytotoxic chemotherapy regimen (second-line).   "
160175|NCT01186978|"     This study will evaluate whether a reduction in the radiation dose and field size will     maintain a high rate of local control while minimizing the risk of acute and late toxicity.      Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy     while maintaining high rates of local control in patients who had a negative PET scan     following rituximab-containing chemotherapy.   "
160176|NCT01186965|"     The purpose of this study is to to develop and evaluate the feasibility, usability, and     effect of participation in SLIDES (a virtual diabetes community in Second Life) for providing     interactive diabetes education, support, and resources.   "
160177|NCT01186952|"     Inactivity and excess energy consumption are leading causes of obesity and type 2 diabetes     which are associated with increased cardio-metabolic risk. In order to reduce the     cardiovascular risk associated with type 2 diabetes, the Canadian Diabetes Association     guidelines (2008) recommends weight loss through caloric restriction and structured physical     activity. However, the comparative effects of different methods to obtain caloric deficit for     weight loss remains to be elucidated. The main objective of this study is to assess the     impact of two strategies of caloric deficit: diet alone or diet and exercise on total fat     mass, epicardial fat and cardiovascular risk factors in overweight and obese adults with type     2 diabetes and at high risk of cardiovascular disease.   "
160178|NCT01186939|"     At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could     be enrolled in an optional extension phase in order to continue treatment with azacitidine     until it became commercially available; the continued treatment was for ethical and safety     reasons only and not to provide additional efficacy data.   "
160179|NCT01186926|"     The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the     HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects     with obstructive sleep apnea (OSA).   "
160180|NCT01186913|"     People with Primary Immune Deficiency (PID) may develop severe, life-threatening infections     as a result of inherited defects in the genes that normally instruct blood-forming cells to     develop and to fight infections. PID diseases include Severe Combined Immune Deficiency     (SCID), leaky SCID, Omenn syndrome (OS), and Reticular Dysgenesis (RD). PIDs may be treated     by transplantation of bone marrow stem cells from a healthy person or, in some cases, by     enzyme replacement or by gene therapy. Patients with SCID were among the first to receive     bone marrow stem cell (also called hematopoietic cells) transplantation (HCT) more than 40     years ago, and HCT is the standard treatment today for this group of diseases. Since PID     diseases are rare, there are not enough patients at any single center to determine the full     range of causes, natural history, or best methods of treatment. For this research study many     PID centers across North America have organized into the Primary Immune Deficiency Treatment     Consortium (PIDTC) to pool their experience and study PIDs together. The overall goal of this     study is the prospective evaluation of children with SCID and related disorders who are     treated under a variety of protocols at participating institutions. The study aims to     identify variables contributing to the best outcomes for HCT.   "
160785|NCT00000222|"     The purpose of this study is to determine if two times a subject's daily maintenance dose     will hold for 48 hours without changes in agonist and antagonist effects.   "
160181|NCT01186900|"     The investigators propose to conduct a, two armed, randomized, controlled pilot study to     assess the clinical effects of a) open incision, drainage with daily packing changes,     compared to b) Ultrasound guided needle aspiration, in drainage of uncomplicated cutaneous     abscesses below the skin surface of adult emergency department patients using concealed     allocation in evaluating patient satisfaction.   "
160182|NCT01186887|"     The aim of this study is to directly compare the clinical outcomes of both the celecoxib and     placebo groups following anterior cruciate ligament (ACL) reconstruction. The study will have     short and long term goals. Validated outcome measures will aim to quantify pain control at 2     weeks after surgery, as well as knee function at 2 year follow-up. Groups will be compared     using pain control scales, and functional knee outcome scores. The first null hypothesis     tested by this study is that the celecoxib group experiences equal pain control compared with     the placebo group. The second null hypothesis is that no knee function difference will be     found between the celecoxib and placebo groups.   "
160183|NCT01186874|"     To survey the prevalence and the mortality of the Acute Lung Injury/ Acute Respiratory     Distress Syndrome (ALI/ARDS) in 12 university hospital ICUs in Shanghai.   "
160184|NCT01186861|"     A multicenter, randomized, double-blind, placebo-controlled, phase 2 study with a 1:1     randomization scheme.   "
160185|NCT01186848|"     This was a prospective randomized controlled study comparing the efficacy of micro-focused     ultrasound when used in conjunction with 1550-nm erbium-doped fractionated laser versus     1550-nm erbium-doped fractionated laser alone for treatment of striae distensae(stretch     marks).      Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment     every 2 weeks for a total of 4 treatments on one side and the contralateral side received     micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks     for a total of 4 treatments with site-match control area of baseline striae on each side.      The primary outcome measure by two dermatologists blindly compared the two areas of striae     distensae on each side from live subjects using a questionnaire and quartile rating scale on     the final follow-up visit.      This study was a pilot study designed to determine the feasibility of these procedures.   "
160186|NCT01186835|"     The objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in     conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of     wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum toxin     alone. These two products have been FDA approved to improve the appearance of facial     wrinkles.   "
160187|NCT01186822|"     This is a 26 week randomized controlled study. The study consists of, in order, an enrollment     visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. There will also be     telephonic assessments at 8 weeks and 20 weeks. Clinic visits will involve comprehensive     assessments of the patients lung condition, including post-bronchodilator spirometry, Shuttle     walk distance, BODE index, health status (SGRQ) and symptoms (CCQ). Sputum and serum samples     will also be collected at these visits for microbiological and inflammation analysis. Sputum     will be obtained with the Lung Flute as an induction device and Pulse Oximetry will be     assessed prior to and after use of the Lung Flute. Clinic and telephonic visits will collect     information regarding compliance with the use of the Lung Flute, adverse events and     exacerbation history.   "
160188|NCT01186809|"     The purpose of the Phase IIA study are to:        1. define the safety profile        2. evaluate the efficacy of a sequential infusion of unmanipulated Donor Lymphocyte          Infusions (DLI) and Cytokine Induced Killer (CIK) cells for the treatment of molecular,          cytogenetic or hematologic relapse after hematopoietic stem cell transplantation and The          progression free survival and the overall survival after the sequential infusion of          Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer(CIK) cells.   "
160189|NCT01186796|"     Participants are being asked to take part in this research study to learn why growth     hormone(GH) levels decline when estrogen production falls at the time of menopause. GH is a     hormone released from the pituitary gland that affects bone, muscle, and fat. Estrogen is a     female hormone. Doctors believe that lower estrogen is one of the reasons that GH diminishes     in postmenopausal women. However, estrogen does not fall completely. This raises the question     whether the little bit of estrogen that is left is doing anything. Lack of GH makes bones     thinner, muscles weaker, and fat stores larger. To learn whether the low amount of the body's     own estrogen maintains GH secretion after menopause, the investigators need to stop any     estrogen you might be taking and then partially block the effect, if any, of your own     estrogen. The investigators will use a new estrogen-blocking drug (fulvestrant).     Fulvestrant(which also goes by the tradename, Faslodex) was recently approved by the Food and     Drug Administration (FDA) to treat breast cancer. Fulvestrant is being used in a non-FDA     approved manner in this study (not to treat breast cancer, but to study the effect on Growth     Hormone secretion). The drug interferes with how estrogen works in the body, except in the     brain. The study that you are considering now tests whether your own estrogen works outside     the brain to maintain GH secretion in postmenopausal women. This concept is important,     because the brain controls how the pituitary gland secretes GH.   "
191321|NCT00350701|"     This is to study the effect of replacing testosterone on different inflammatory cells in type     2 diabetics with low testosterone levels.   "
160193|NCT01186744|"     The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5     mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and     subsequent withdrawal of active treatment at various timepoints during the 16 week double     blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP     690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and     subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID     and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are     candidates for systemic therapy or phototherapy.   "
160231|NCT01186250|"     The purpose of this study is to determine the benefit of using the FDA-approved     insulin-sensitizing agent, Pioglitazone, on human heart transplant recipients. The objectives     of this project are to (1) determine if pioglitazone effectively treats insulin resistance in     heart transplant recipients, and (2) to determine whether pioglitazone therapy after heart     transplantation impacts the development or progression of cardiac allograft vasculopathy     (CAV), a form of chronic rejection after heart transplantation.   "
160194|NCT01186731|"     LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc.     Docetaxel (currently marketed as Taxotere) is an anti-microtubule agent that prevents cell     division. By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced     toxicity and comparable therapeutic efficacy in pre-clinical study. The clinical evidence     obtained from the NeoPharm Phase I study shows fewer side effects and possibly administered     at higher dose to induce greater effectiveness of LE-DT. In addition, docetaxel has shown     positive activity of protein bound taxane therapy in treating patients with pancreatic     cancer. The current Phase II study is designed to accomplish the following objectives:        1. Assess the antitumor effect of 110 mg/m2 LE-DT administered intravenous (IV) every three          weeks in pancreatic cancer patients with locally advanced or metastatic disease        2. To evaluate the progression-free survival and overall survival        3. To correlate secreted protein acid rich in cysteine expression with tumor response        4. To evaluate the safety of LE-DT, in particular peripheral neuropathy, water retention as          well as myelotoxicity        5. To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic          endpoints, including toxicities.   "
160195|NCT01186718|"     The purpose of this project is to quantify 3-dimensional (3-D) cervical motion pattern     changes that result from osteopathic manipulation treatment (OMT) in an experimental subject     group diagnosed with somatic dysfunction. The kinematic data will include the entire 3-D     motion trajectories of the head, resulting in range of motion (ROM) and angular data for the     primary and secondary motions.   "
160196|NCT01186705|"     The purpose of this study is to test a new drug called MK-2206 for metastatic colorectal     cancer. This drug is being tested in a subgroup of patients with colorectal cancer whose     tumors have changes in certain genes that may make them more likely to respond to this new     medication. As tumors develop, the cells within the tumor acquire mutations within genes,     allowing them to grow more effectively. We will be testing your tumor for mutations involving     two genes - KRAS and PIK3CA. Patients whose tumors have a normal copy of the KRAS gene and a     mutation within the PIK3CA gene will be eligible to participate in this study.      This study is a phase 2 study. The goal of a phase 2 study is to find out what effects, good     and/or bad, a new treatment has against a certain type of cancer.   "
160197|NCT01186692|"     The purpose of this study is to confirm the short-term hemodynamic effectiveness results     achieved by real-world providers are equivalent to the historical control established in the     IDE study.   "
160198|NCT01186679|"     The projected data related to the burden of spinal cord injuries induced limb paralysis in     India is quite alarming. This is attributed to the rapid industrialization and economical     development in the country. Increase in vehicular traffic has caused numerous road traffic     accidents. Rapid increase in populations, development in the computer technology and real     estate business lead to construction of huge buildings which indirectly adds to the injuries     due to fall. Spinal cord injuries could not be treated adequately with the prevailing     treatment modalities. In view of this, there is definitely an urgent need for finding     different methods of treatment for these patients who cannot undergo established modalities     of treatment or these have been tried unsuccessfully. Since a large number of these patients     will loose their productive life and at the prime of their lives, one such alternate therapy,     which seems to offer some promise, is stem cell therapy, which has been well studied and     published in prestigious journals.      In our present study, we want to evaluate the safety and efficacy of autologous bone marrow     derived stem cells surgically transplanted directly into the lesion site with glial scar     resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for     4 indian patients of acute and subacute injury.   "
160199|NCT01186666|"     In this study, multimodal imaging of atherosclerosis and dosage of new circulating biomarkers     will be used to compare patients with stable or unstable coronary artery disease   "
160200|NCT01186653|"     National Institute for Clinical Excellence (NICE) guidelines recommend high dose inhaled     steroids for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD, a     common chronic disease related to smoking) who are having two or more exacerbations requiring     treatment with antibiotics or oral steroids in a 12 month period. The preparations licensed     for this indication commercially available are Symbicort® and Seretide®. High dose inhaled     steroids (contained in both) can cause suppression of the adrenal glands. The investigators     want to assess adrenal suppression caused by the two preparations and compare. The results     could guide investigators in prescribing these preparations.   "
160201|NCT01186640|"     Study hypothesis: Simultaneous FMC-Alemtuzumab administration followed by Alemtuzumab     maintenance therapy in patients with T-PLL is feasible, safe and efficient.   "
160202|NCT01186627|"     A specified version of the Apgar-Score, that can be used in newborns under resuscitation, was     developed and its value to predict chronic damage in preterm infants will be tested.   "
160212|NCT01186497|"     The purpose of the study is to investigate the bioavailability (rate and extent of     absorption) of rabeprazole sodium when a sprinkle capsule granule formulation of rabeprazole     sodium is mixed with different dosing vehicles (food, others) and is administered to healthy     adult volunteers. Rabeprazole sodium is a drug used to treat patients with Gastro Esophageal     Reflux Disease (GERD). GERD is a condition in which the esophagus (tube from throat to     stomach) becomes irritated or inflamed because of acid backing up from the stomach.   "
160213|NCT01186484|"     The purpose of this study is to assess pharmacodynamics and safety of JNJ-212082 in order to     select the recommended dose of JNJ-212082 for patients with castration resistant prostate     cancer.   "
160214|NCT01186471|"     This study in patients with stable schizophrenia will investigate the effect of nicotine on     arousal, cognitive task and social cognition after acute dose administration.   "
160232|NCT01186237|"     Recent national surgical quality guidelines (Surgical Care Improvement Project, National     Hospital Inpatient Quality Measures)state that removal of urinary catheters should occur by     post-operative day two for all surgical patients. These guidelines exclude neither patients     who have undergone rectal surgery nor those with epidural analgesic catheters. The common     practice among most colorectal surgeons is to leave urinary catheters in for three to five     days for patients who have undergone rectal operations, due to concern for urinary retention.     This study aims to explore the outcomes of following the national surgical guidelines for     early urinary catheter removal, especially with regards to urinary retention and urinary     tract infection.   "
160203|NCT01186614|"     Sudden out-of-hospital cardiac arrest (OHCA) is a leading cause of death in Australia. The     most common cause of OHCA is a heart attack. The current treatment of OHCA is resuscitation     by ambulance paramedics involving CPR, electrical shocks to the heart, and injections of     adrenaline. In more than 50% of cases, paramedics are unable to start the heart and the     patient is declared dead at the scene. Patients with OHCA who do not respond to paramedic     resuscitation are not routinely transported to hospital because it is hazardous for     paramedics to undertake rapid transport whilst administering chest compressions and there is     currently no additional therapy available at the hospital that would assist in starting the     heart.      However, a number of recent developments suggest that there may be a new approach to the     resuscitation of this group of patients who would otherwise die.      Firstly, Ambulance Victoria have recently introduced portable battery powered machines that     allow chest compressions to be safely and effectively delivered during emergency ambulance     transport.      Second, The Alfred ICU will shortly be implementing a new protocol whereby the patient in     cardiac arrest can immediately be placed on a heart-lung machine. This is known as     extra-corporeal membrane oxygenation (ECMO).      Third, the brain can now be much better protected against damage due to lack of blood flow     using therapeutic hypothermia which is the controlled lowering of body temperature from 37°C     to 33°C. Clinical trials have demonstrated that this significantly decreases brain damage     after OHCA.      Finally, The Alfred Cardiology service has an emergency service for reopening the blocked     artery of the heart in patients who present with a sudden blockage of the heart arteries.     This is currently not used in patients without a heart beat because of the technical     difficulty of undertaking this procedure with chest compressions being undertaken.      This study proposes for the first time to implement all the above interventions when patients     have failed standard resuscitation after OHCA. When standard resuscitation has proved futile,     the patient will be transported to The Alfred with the mechanical chest compression device,     cooled to 33°C, placed on ECMO, and then transported to the interventional cardiac catheter     laboratory. The patient will then receive therapeutic hypothermia for 24 hours. Subsequent     management will follow the standard treatment guidelines of The Alfred Intensive Care Unit.   "
160204|NCT01186601|"     The study will be conducted as an open label, single-dose, explorative study with patients     with histologically proven cancer and, preferably, tumor positive lesions in previously     performed nuclear medicine imaging examinations.      The investigational drug will be given as a single administration in a dose of </= 0.1 mg     BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be     approximately 8 days.   "
160205|NCT01186588|"     The purpose of the study is to determine the concentration of canagliflozin in blood and     urine samples after the administration of canagliflozin to study participants with mild or     moderate hepatic (liver) impairment compared with study participants with normal hepatic     function.   "
160206|NCT01186575|"     Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and     UNAIDS recommend that male circumcision should be recognized as an efficacious intervention     for HIV prevention especially in countries and regions with heterosexual HIV epidemics and     low male circumcision prevalence. As a result, programs have been introduced and scaled up     for voluntary medical male circumcision. Kenya leads with the largest expansion of services.      Early resumption of sexual intercourse after MC may have deleterious effects, including     higher rates of post-operative surgical complications, and higher HIV acquisition among     females in couples that resume sexual activity before certified wound healing. In the context     of rapid scale-up of MC, adherence to post-operative clinic appointments allows clinicians to     assess wound healing and to deliver risk reduction counseling. Abstinence from sexual     intercourse before complete wound healing would reduce the rate of post-operative adverse     events and minimize the risk of HIV transmission from HIV-infected men to their uninfected     female partners.      To the investigators knowledge, the effect of reminders delivered via text messaging to     promote adherence to clinic visits and abstinence after MC has not been investigated. The     investigators propose a randomized controlled trial in which men who will have undergone     voluntary medical male circumcision at selected sites in Kisumu will be randomized to receive     either the intervention (context-sensitive text messages after circumcision) or the control     condition (usual care). This study seeks to determine (a) the effect of regular text messages     sent to men after circumcision on attendance of the scheduled 7-day post-operative clinic     visit versus usual care; (b) the proportion of men who resume sexual activity before 42 days     post-procedure after receiving regular text messages versus usual care within the 42 days     post-circumcision; and (c) to identify potential predictors of failure to attend the     scheduled 7-day post-operative visit and early resumption of sexual intercourse.   "
160207|NCT01186562|"     The purpose of the study is to test the effects of sitagliptin on the need for insulin (the     hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet     autotransplant for chronic pancreatitis.   "
160208|NCT01186549|"     Objectives: Injection pain and hypotension are two main adverse effects of propofol which     distresses patient. The aim of this prospective double blind study was to compare the effect     of ephedrine -lidocaine combination with lidocaine and ephedrine on injection pain and     hemodynamic changes due to propofol induction.      Methods: 165 adult patients, aged 20 to 60 yr, Patients were randomly allocated to one of 5     groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30microgram/kg (E30),     ephedrine 70 microgram/kg(E70), lidocaine 0.5mg/kg -ephedrine 30 microgram/kg(LE) or 2ml     saline (S) intravenously. After one minute propofol 2 mg/kg into a dorsal hand vein was     injected. Face pain scale and verbal rating scale, arterial blood pressure and heart rate     were recorded before induction, just before intubation, and one minute after intubation   "
160209|NCT01186536|"     The objective of this project is to determine the effect of 9 months of progressive     resistance training with daily whey protein supplements on the body composition (changes in     muscle and fat) in young adults. The investigators hypothesize that those individuals who     receive whey protein supplements will have larger gains in muscle and larger losses of fat     tissue in response to resistance training compared to those who receive supplements of soy or     carbohydrate.   "
160210|NCT01186523|"     In order to examine potential gender differences in the weight loss response to exercise, the     investigators propose to compare equal energy expenditure of exercise for overweight men and     women using levels of exercise energy expenditure that the investigators have previously     shown to prevent weight gain or promote weight loss. The investigators will randomize men and     women to an exercise group, 5 days/week, for 9 months, with an energy expenditure of 400     kcal/exercise session, a group with 600 kcal/ exercise session, or a control group. 1)The     investigators hypothesize that men and women randomized to sedentary control will gain     weight, those randomized to 400 kcal/exercise session will maintain weight (will not gain),     and those randomized to 600 kcal/exercise session will lose ~5% of body weight. 2) The     investigators hypothesize there will be no differences for weight loss between genders at     either 400 or 600 kcal of energy expenditure of exercise since men and women will have equal     amounts of energy expenditure of exercise. 3) The investigators hypothesize that men and     women randomized to 400 kcal/exercise session will completely compensate for the energy     expended during exercise by altering energy intake and/or spontaneous activity and that men     and women participants randomized to 600 kcal/exercise session will not completely     compensate. The investigators believe the findings from this study could have important     implications for exercise guidelines for weight loss.   "
160211|NCT01186510|"     Pulmonary dysfunction presumably linked to an inflammatory response is frequent after cardiac     operations using cardiopulmonary bypass (CPB) and pulmonary hypoperfusion.      Aim of the study: To evaluate the protective effect of continuous pulmonary perfusion with     oxygenated blood during aortic crossclamping on the inflammatory response.   "
160218|NCT01186419|"     The purpose of this research study is to evaluate the safety of two doses of FBS0701, a new     oral iron chelator, and its effectiveness in clearing iron from the liver. FBS0701 is a     medication taken by mouth that causes the body to get rid of iron. Iron chelators are used in     patients with β-thalassemia and other forms of anemia who experience iron overload - iron     increases in the body as a result of regularly required blood transfusions. Patients who     qualify will be randomized to receive one of two doses of FBS0701 for up to 24 weeks (6     months) with a total study duration of up to 33 weeks. These patients will be eligible to     participate in a dosing extension for up to 72 weeks. The maximum duration of dosing will be     up to 96 weeks. The safety of patients will be monitored frequently during the study by     physical exams, ECGs, and blood tests. To assess the amount of iron in the liver and heart,     each patient must undergo 6 MRI scans during the study. Patients will not need to stay in the     hospital for this study but will need to visit the outpatient clinic up to 28 times over the     96 week period. Patients currently taking an iron chelator will be required to stop for a     total of up to 26 weeks. The results of this study will help to determine if FBS0701 may be     effective as an iron chelator.   "
160219|NCT01186406|"     The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at     the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and then     the combination of Avastin and Temodar, after radiation is complete, on malignant brain     tumors.      About six weeks after surgery, subjects will begin standard radiation therapy, a fixed dose     of Avastin every 2 weeks, and daily Temodar for the six and a half weeks of radiation.     Beginning 2-3 weeks after the last radiation therapy, subjects will be given the same fixed     dose of Avastin intravenously (through the vein) every 14 days. They will also be given a     higher dose of oral Temodar to take daily the first 5 days of each 28-day study cycle.   "
160220|NCT01186393|"     The purpose of this study is to test whether diets that contain potatoes and differ in     glycemic index/load will be useful in weight loss, blood sugar control and maintaining     current body weight.   "
160221|NCT01186380|"     The objective of this Study is to demonstrate the safety of the PET-512MC TEE transducer as     it is inserted and transitioned into the esophagus through the mouth.   "
160222|NCT01186367|"     The purpose of this study is to compare the effects of 3 different approaches to exercise     training in women with early stage breast cancer who have completed all primary treatments     (except hormone therapy, if appropriate). Prior research in women with early stage breast     cancer has shown that some treatments may have an adverse impact on physical fitness levels     leading to feelings of fatigue and poor quality of life. Supervised exercise training has     been shown to reduce some of these side-effects. However, all the exercise programs have     followed essentially the same approach. This study is designed to see if a different approach     to exercise training is more effective than the conventional approach currently in use.   "
160223|NCT01186354|"     This research study is being conducted to learn about how health and genetic literacy (i.e.,     how well a person understands health and genetic information) affects a person's ability to     understand genetic risk information for Type 2 diabetes and whether that person chooses to     change their lifestyle and health behaviors to reduce their risk. The investigators also want     to learn if the manner in which the genetic risk information is communicated affects the     level of understanding and potential behavior changes. Participants will be tested for     genetic risk of developing Type 2 diabetes and will received results either via a web-based     computer program, or in-person from a genetic counselor.   "
160224|NCT01186341|"     Preliminary results from an ongoing cross-sectional survey of nine of the BraveNet Outpatient     Clinics indicate that pain was the leading reason for patient visits. As a precursor to a     large multi-site clinical trial, this study aims to determine the feasibility of collecting     outcomes data on integrative treatment for pain. These preliminary data will also provide an     estimation of effect size for powering the multi-site clinical trial.   "
160225|NCT01186328|"     An experimental drug called EZN-3042 targets survivin, a protein expressed in leukemia cells     at relapse that promotes the leukemia cells to grow. The main goal of this phase I study is     to find out the dose of EZN-3042 that can be safely given without serious side effects both     alone and in combination with standard chemotherapy drugs during re-induction.   "
160226|NCT01186315|"     Eligible veterans, National Guardsmen & Reservists with post-traumatic stress disorder (PTSD)     and problems with addiction will be randomly assigned to one of two treatment conditions. All     participants will undergo exposure therapy, a gold standard behavioral treatment for PTSD for     10 weeks. In addition to exposure therapy, some participants will be randomly assigned to     receive (1) virtual reality (VR)-based exposure to cues for marijuana, cocaine, heroin,     cigarette, and/or alcohol use, and (2) cellular phone-based reminders of learning (extinction     reminders, or, ERs) to VR exposure (available 24 hours per day/7 days per week) to high-risk     contexts for drug use. The main hypothesis is that those participants who receive exposure     therapy + VR/ERs will demonstrate less substance use and lower PTSD symptoms during     treatment, at post-treatment, and at follow-up than those participants who only receive     exposure therapy. At study completion, a total of 123 subjects signed consent.   "
160227|NCT01186302|"     The purpose of the study is to compare the safety, effectiveness, and acceptability of     medical abortion provided by doctors and midlevel providers in a developing country where     doctors are scarce, such as Nepal. This study is the first to evaluate the independent     provision of medical abortion by trained nurses and auxiliary nurse midwives compared to     doctors by assessing differences in safety, clinical outcomes, case management     decision-making, and acceptability. This study provides scientifically valid data on the     administration of medical abortion by midlevel providers working independently in a     low-resource, developing country setting. The evidence generated by the study will assist     policy makers in developing countries interested in expanding safe abortion services by     eliminating the legal requirement limiting prescription of medical abortion to doctors where     medical abortion is not restricted by law.   "
160228|NCT01186289|"     The primary aim of our prospective, randomized, double-blind interventional clinical trial is     to determine the effectiveness of high dose atorvastatin therapy to reduce post operative     cognitive dysfunction (POCD) in patients undergoing cardiac valve surgery. We hypothesize     that therapy with high dose atorvastatin will significantly reduce the incidence and/or     severity of POCD.   "
160234|NCT01186211|"     This proposal outlines the investigators plan to develop, evaluate and implement an     accelerated in hospital and community rehabilitation following total knee arthroplasty (TKA)     leading to outpatient TKA. The benefits of applying current concepts of improved     postoperative analgesia and less invasive surgical technique are expected to improve     objective parameters of knee function, increase patients satisfaction, while reducing health     care resources requirements as compared with standard rehabilitation. The innovation of     combining best practices from orthopaedic sports medicine, Anesthesia, Physiotherapy and Knee     reconstruction are expected to realize this goal.   "
160235|NCT01186198|"     This is a prospective, single-arm, open-label, multi-center, observational study to assess     the acute safety and efficacy of MINI TREK RX 1.20 mm, for descriptive purposes only.   "
160236|NCT01186185|"     The standard of care treatment of sudden hearing loss uses a type of steroid called     glucocorticoid. Examples of glucocorticoids are prednisone, methylprednisolone and     dexamethasone. Not everybody recovers hearing with glucocorticoid treatment. Fludrocortisone     is a different type of steroid called mineralocorticoid. Unlike glucocorticoids, which work     by reducing inflammation, mineralocorticoids work by changing salt and fluid balance. In     animal studies, fludrocortisone is at least as effective as glucocorticoid in preserving     hearing. Fludrocortisone is not approved for the treatment of sudden hearing loss. The     purpose of this study is to test whether fludrocortisone can treat sudden hearing loss.   "
160237|NCT01186172|"     Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes     it is very difficult to treat the infection and it is necessary to remove the device. The     purpose of this study is to determine the efficacy of instilled ethanol (ethanol lock     therapy) versus instilled antibiotics (antibiotic lock therapy) to save long-term venous     device when infected, preventing their removal.   "
160238|NCT01186159|"     To investigate the dose-effect relations among the expression of COX-2 in polymorphonuclear     leukocytes (PMNL) and macrophages, systemic and local inflammatory response and postoperative     pain   "
160239|NCT01186146|"     This is randomized-controlled trial to evaluate the difference of composite of cardiac death,     myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin     monotherapy group after 1-year of drug-eluting stents implantation.   "
160240|NCT01186133|"     The objective of this study is to evaluate effectiveness and safety of the new drug-eluting     stent (DES), as compared with the first-,second-,third-, and fourth-generation DES, in the     real world daily practice.   "
160241|NCT01186120|"     This randomized study is a multi-center, randomized, study to compare the efficacy of     biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) for long     coronary lesions.   "
160242|NCT01186107|"     The purpose of this study is to establish the safety and effectiveness of coronary stenting     with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment     of de novo coronary stenosis in patients with diabetic patients.   "
160243|NCT01186094|"     This randomized study is a multi-center, randomized, study to compare the efficacy of     sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) implantation for long     coronary lesions.   "
160244|NCT01186081|"     Based on the potential advantaged of preoperative chemoradiotherapy and oral     fluoropyrimidine, the investigators planned a prospective randomized phase III trial which     compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional     radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy     regimen in locally advanced rectal cancer.   "
160245|NCT01186068|"     The purpose of this study is to evaluate the dose-response relationship (effect) of four     concentrations of V-101 Cream in patients with erythematous(redness) rosacea.   "
160246|NCT01186055|"     In the current study, the investigators propose to test: (1) whether brain activation and     connectivity in a resting state, assessed by ASL perfusion MRI, BOLD fMRI, and diffusion     tensor imaging (DTI) predicts smoking relapse, and (2) whether brain activation, assessed by     BOLD fMRI during performance of neurobehavioral probes for executive cognitive function,     stress and cue reactivity, predicts smoking relapse.   "
160247|NCT01186042|"     The purpose of this study is to find the best tests to use to investigate the differences     between older and younger people with HIV disease. Test to be included will measures of     memory, learning, activity levels, sleep patterns, emotional well-being and sexual health.   "
160248|NCT01186029|"     This study is looking at whether the addition of a fairly new drug for the treatment of     post-operative nausea and vomiting (PONV) and post-discharge nausea and vomiting(PDNV)will     provide added efficacy if added to 2 drugs that are already used as a standard of care for     PONV and PDNV.      The patients that will be looked at will be deemed at higher risk for PONV and PDNV based on     the procedure they are having done and/or on patient risk factors.   "
160249|NCT01186016|"     This study will test the effects of an educational program about genetics and smoking on     smokers' thoughts, feelings, and behaviors before and after participating in smoking     cessation treatment. This includes describing participants' knowledge about genetics and     smoking, their use of strategies to stop smoking, and experiences when quitting smoking. This     study will determine how smokers respond to information about genetics and smoking in     anticipation of using genetic information to individualize pharmacological therapy for     smoking cessation.      Two groups will participate in this study. The experimental group will participate in two     educational sessions about genetics and smoking. The control group will participate in two     educational sessions about nutrition. Both the experimental and control groups will     participate in a standard, group smoking cessation program with 6 weeks of OTC transdermal     nicotine replacement therapy. Assignment to either of the two groups is random.      The primary specific aim is to compare the effects of the experimental group to the attention     control group on smoking-related mental representations, appraisals, behaviors, and affective     responses over time. The secondary aim is to explore whether personality characteristics     (trait negative affectivity and curiosity) and educational level moderate the effects of the     genetic educational program on smoking-related mental representations, appraisals, behaviors,     and affective responses. The hypotheses of the study are as follows:        1. When compared to the attention control group, the experimental group will demonstrate:             -  Smoking-Related Mental Representations:             -  Greater knowledge of genetic contributions to smoking             -  Greater endorsement of genetic contributions to smoking             -  More positive attitudes towards NRT             -  Increased abstainer and decreased smoker self-schemas             -  Smoking-Related Appraisal: greater perceived risk for genetic predispositions to               smoking             -  Smoking-Related Behaviors: greater interest in genotyping.        2. When compared to the attention control group, the experimental group will differ in:             -  Smoking-Related Appraisals: self-efficacy for cessation and abstinence             -  Smoking-Related Behaviors: number of quit attempts, abstinence, nicotine dependence             -  Affective Responses: negative affect and intrusive/avoidant thoughts   "
160250|NCT01186003|"     The investigators anticipate that the use of Detemir will decrease the duration of an insulin     drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit)     length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin     drip is discontinued.   "
160786|NCT00000223|"     The purpose of this study is to determine if three times a subject's daily maintenance dose     will hold for 72 hours without changes in agonist and antagonist effects.   "
160251|NCT01185990|"     The study is designed to identify specific patterns of brain functional activity associated     with chronic, moderate to severe tinnitus through the use of resting-state MEG scans. Robust     patterns identified in this study will be used as a biomarker for subsequent clinical     evaluation of experimental drug treatments for tinnitus. This study will conduct MEG scans on     approximately 30 to 75 subjects with tinnitus and approximately 15 healthy control subjects.     MEG scans will be obtained for each subject following screening, clinical and tinnitus     evaluations. A subset of 6 subjects from the tinnitus cohort will be invited to undergo     evoked auditory assessment during an extended MEG scan session to identify cortical regions     that respond to the auditory stimulus. These six subjects also will be evaluated with a     single structural MRI scan to support high-resolution mapping of the localized cortical     regions. MEG data will be analyzed to identify patterns of brain activity that are     specifically associated with the presence of tinnitus using both standard approaches and the     Orasi Synchronous Neural Interaction™ (SNI) test. MEG scan results also will be evaluated to     identify specific patterns of functional activity that correlate with other measures of     tinnitus severity such as the Iowa Tinnitus Handicap Scale. This study will test the     hypothesis that moderate to severe tinnitus is associated with altered patterns of brain     functional activity measured by a brief, resting-state MEG scan. This hypothesis will be     tested by comparing resting-state MEG scans of tinnitus patients with those the of healthy     control subjects collected during this study and available in Orasi's existing MEG scan     database.   "
160252|NCT01185977|"     This study will aim to evaluate the use of Electroencephalography (EEG) biomarkers in     adolescent depression. Two specific hypotheses will be tested:      H1: Early decreases in prefrontal cordance values will be greater in responders to     antidepressant therapy than in medication non-responders.      H2: Subjects with high Antidepressant Treatment Response(ATR) Index values [i.e., predicted     to show symptomatic improvement with fluoxetine (FLX)] will achieve greater improvement in     symptoms and in functional status than those with low ATR values.      Exploratory analyses will be undertaken to compare and contrast the cordance changes and ATR     values in medication and placebo-treated responders and non-responders.   "
160253|NCT01185964|"     The main purpose of this study is to gather information about the use of an investigational     drug called olaratumab with a drug for soft tissue sarcoma called doxorubicin.   "
160254|NCT01185951|"     Athletic tendinopathies of the upper and lower extremity are often therapeutically     challenging. Colour and Power-Doppler-ultrasound visualizes pathological neovessels in     painful tendons, which are associated with pain-mediating nerve fibres in such     tendinopathies. These neovessels are represented by an increased capillary blood flow at the     point of pain. Painful eccentric training reduces pain and improves function in Achilles     tendinopathy substantially (evidence level Ib). Shock wave therapy in combination with     eccentric training is superior to eccentric training alone (evidence level Ib). Long-term     results suggest a collagen induction and reduced pain following topical glyceryl trinitrate     (NO) (evidence level Ib). Colour- and Power-Doppler-guided sclerosing therapy using     polidocanol reduces pain, improves function and may lead to tendon remodelling (evidence     level Ib). Pain-restricted sport beyond pain level 5/10 during therapy is recommended     (evidence level Ib). 3x10min of cryotherapy reduce pain and capillary blood flow (evidence     level Ib). The role of proprioceptive training in tendinopathy has to be determined in future     randomized-controlled trials (evidence level II).      The investigators thought to evaluate the combination of the aforementioned individually     successfully therapeutic options in athletes to shorten the recovery period and return to     play interval.   "
160255|NCT01185938|"     This open-label study, prospective, randomized trial evaluating the acute (in-hospital)     pleiotropic and clinical effects of a hydrophilic statin (rosuvastatin) in patients with     acute coronary syndrome   "
160256|NCT01185925|"     Exercise oscillatory breathing (EOB) is a ventilatory abnormality that occurs in     approximately 20% of heart failure (HF) patients and carries a very unfavourable prognosis.      Pathophysiology seems quite complex and putative mechanisms include increased pulmonary     capillary pressure and pulmonary vasoconstriction, circulatory blood-flow fluctuations in the     pulmonary arterial system and instability of ventilatory control.      Inhibition of the phosphodiesterase 5 (PDE5) isoenzyme favourably regulates pulmonary     vascular tone and permeability through over signaling of the endothelial nitric oxide     pathway. The investigators tested the hypothesis that sildenafil would reverse the EOB     pattern in patients with HF and pulmonary hypertension.   "
160270|NCT01185743|"     Schizophrenia is a severe chronic and disabling mental disorder and is associated with a     significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be     jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid     metabolism.      Aim: to gain data on drug related effects on gene expression and regulation with special     regard to glucose metabolism.   "
160763|NCT00000200|"     The purpose of this study is to compare the effects of buprenorphine or methadone maintenance     on cocaine taking and on the physiological and subjective effects of cocaine, including     cocaine craving, in opiate-dependent cocaine users.   "
160257|NCT01185912|"     Retrograde cardioplegia during heart surgery is associated with inadequate myocardial     protection. In experimental animal study retrograde cardioplegia induces more cardiomyocyte     apoptosis when compared to antegrade cardioplegia. 20 volunteer patients under going elective     aortic valve surgery will be divided in to two groups: 10 patients receiving only antegrade     cardioplegia and 10 patients receiving only retrograde cardioplegia. Pre- and     post-operatively cardiac MRI and cardiac ultrasound will be performed. During the surgery     ventricular muscle samples will be taken in order to assess cardiomyocyte apoptosis. Aims of     the study: 1. whether the cardiomyocyte apoptosis is significantly more induced after     retrograde cardioplegia than antegrade cardioplegia, 2. whether the amount of apoptotic     cardiomyocytes correlates to conventional markers of myocardial injury after cardiac surgery,     3. whether the extent of irreversible myocardial damage by apoptosis correlates to     post-ischemic contractile dysfunction after cardiac surgery, as measured with     echocardiography, 4. whether the amount of cardiomyocyte apoptosis correlates to long term     outcome and cardiac function as measured with MRI.   "
160276|NCT01185665|"     The study investigates the feasibility and efficacy of Transcutaneous Electrical Nerve     Stimulator (TENS) in a subgroup of patients with neuropathic pain. Those patients are     suffering of neuropathic pain at the lower back and leg after spinal surgery with a     predominance of pain in the leg.   "
160258|NCT01185899|"     Accurate detection of a heart attack (an acute myocardial infarction) is one of the most     pressing needs in medicine. Recordings of the electrocardiogram (ECG) (electrical activity of     the heart) are one of the first tools used to diagnose a heart attack, but the ECG is not     very accurate, especially at the beginning of a heart attack. A new technique for analysing a     special part of the ECG may provide more accurate detection of a heart attack. The study     hypothesis is that this new technique, the HFQRS analysis, will provide important additional     information to that available from the regular ECG.   "
160259|NCT01185886|"     RATIONALE: Collecting and storing samples of tumor tissue, blood, bone marrow, and other body     fluids from patients to test in the laboratory and collecting information about the patient's     health and treatment may help doctors learn more about cancer and help the study of cancer in     the future. Studying these samples in the laboratory may help doctors learn more about     changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors     predict how patients will respond to treatment.      PURPOSE: This research study is collecting and looking at blood and tissue samples in     children with newly diagnosed acute lymphoblastic leukemia.   "
160260|NCT01185873|"     This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and     the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and     patients with mild, moderate or severe hepatic impairment. Participants will be administered     repeated daily doses of danoprevir and ritonavir. The anticipated time on study treatment is     10 days.   "
160261|NCT01185860|"     This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus     ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic     hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in     cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus     ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once     weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after     completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.   "
160262|NCT01185847|"     This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in     combination with standard chemotherapy in patients with advanced or recurrent non-small cell     lung cancer who have not received prior chemotherapy. In Part 1 patients will receive     RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or     pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In     Part 2 patients will be randomized to receive either RO5083945 in combination with standard     chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression,     patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.   "
160263|NCT01185834|"     The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact     lens.   "
160264|NCT01185821|"     This blinded extension study is designed to offer patients with relapsing-remitting MS having     completed the core study CBAF312A2201 access to BAF312 until they can enter an open label     study. It will provide data on long-term safety, tolerability and efficacy of BAF312 in this     patient population.   "
160265|NCT01185808|"     The purpose of this study is to determine if Vitamin D supplementation improves clinical and     immunologic parameters in chronic rhinosinusitis with nasal polyps.   "
160266|NCT01185795|"     Background: Several studies have reported limited or no reduction in serum lipid     concentrations in response to probiotic formulations. More recently, probiotics have shown     promise in treating metabolic disease, due to improved strain selection and delivery     technologies.      Objective: To evaluate the lipid lowering efficacy of a yogurt formulation containing     microencapsulated Bile Salt Hydrolase (BSH)-active Lactobacillus reuteri cardioviva, taken     twice per day over 6 weeks, in subjects with hypercholesterolemia.      Design: This is a double-blinded, multi-centric, placebo-controlled, randomized, parallel-arm     study. The study will last a total of 10 weeks including 2-week wash-out, 2-week run-in, and     6- week treatment period.   "
160267|NCT01185782|"     Efficacy and safety studies in the past have suggested that a starting dose of 75     International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are     safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic     or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including     oligomenorrhea and polymenorrhea).      This was a phase III, multicentre, single-blind, parallel-group comparative study conducted     to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin,     a comparator drug, for induction of follicle development and ovulation in infertile Japanese     women and to provide further information on the safety and tolerability of SJ-0021.   "
160268|NCT01185769|"     Despite the emerging interest in tocotrienols, the absorption of tocotrienols in humans     remains unclear especially with different fat diets.This study aimed at evaluating the     absorption and distribution of tocotrienols in plasma and lipoproteins in associations with     high and low fat diets. Different fat level will affect the absorption and distribution of     tocotrienols   "
160269|NCT01185756|"     The aim of the study is to assess the cardiac innervation in patients with heart failure to     better select candidates for an implantable cardioverter defibrillator. Cardiac innervation     will be assessed using an imaging agent administered intravenously.   "
160271|NCT01185730|"     The objective of this clinical research is to analyze the survival of a cohort of patients     newly diagnosed (incident cases) with idiopathic PAH, familial or associated with the use of     anorectics (isolated pulmonary vascular disease without comorbidity) and identify prognostic     factors using a dynamic model for predicting survival, including prognostic factors evaluated     repeatedly at pre-specified periods during follow-up. In a second step, the investigators     define using this model combinations of parameters to better define the therapeutic goals in     PAH (functional class, exercise testing, hemodynamic, echocardiographic variables, biological     parameters).   "
160272|NCT01185717|"     The objective of the study is to estimate the prevalence of anti-JCV antibodies in multiple     sclerosis (MS) participants.   "
160273|NCT01185704|"     This is a randomized open-label study to compare between in-vitro     fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of     Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the     menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted     reproductive technology (ART).   "
160277|NCT01185652|"     Tobacco-smoking causes lung function decline with airflow obstruction, which may be     accelerated in persistent smokers.This would eventually lead to chronic obstructive pulmonary     disease (COPD), a leading cause of morbidity and mortality in Hong Kong and globally. Lung     function decline is gradual and not appreciated by the smoker until damage is advanced, and     often under-recognised in the early stages of disease by healthcare providers. Spirometry is     an established lung function measurement tool, and the most simple objective method to detect     lung function decline. There is literature suggesting that newer spirometric parameters, FEV3     and FEV6, which are easier to achieve in the measurement process than conventional     parameters, are comparable alternatives in detecting lung function decline.      The aims of this study are:        1. to evaluate and compare lung function decline in persistent smokers and non-smokers        2. to study the usefulness of FEV3/FVC and FEV1/FEV6 in detecting lung function decline        3. to correlate symptom scores with lung function parameters        4. To correlate serum biomarker levels with respiratory symptoms and lung function          parameters in smokers and non-smokers      This is a follow-up study on a territory wide cohort including smokers and non-smokers, who     have undergone lung function testing in 2001-03. Subjects will be invited to have repeat lung     function assessment.      The hypotheses of this study are:        1. smokers have significantly greater decline in lung function compared to non-smokers in          Hong Kong Chinese;        2. newer lung function parameters are useful alternatives in detecting lung function          decline        3. serum inflammatory biomarker (IL-8, TGF-β, MMP9, TIMP-1, CRP) levels correlate with          respiratory symptoms and lung function parameters in smokers when compared with          non-smokers   "
160278|NCT01185639|"     This protocol is a single arm phase II multi-center trial evaluating the efficacy of     Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell     lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line     chemotherapy. The core hypothesis tested is that SBRT after 4 cycles of first-line     chemotherapy is feasible, safe, provides durable local control of treated lesions and     improves time to progression compared to historical controls. Patients are eligible for     enrollment if they have metastatic NSCLC with ≤5 lesions amenable to SBRT.   "
160279|NCT01185626|"     Earlier diagnoses and improved treatments have contributed to the growing cohort of cancer     survivors. Nevertheless, these patients remain at risk for adverse long-term or late physical     or psychosocial effects of cancer and its treatment. There is increasing recognition to     improve information disclosure and cancer survivorship care. The American Institute of     Medicine (IOM) and Health Council of the Netherlands both recommend that cancer survivors     receive a summary of their course of treatment as a formal document, that also includes     recommendations for subsequent cancer surveillance, management of late effects, and     strategies for health promotion, the Survivorship Care Plan (SCP). However, no evidence     exists concerning the positive and negative effects of the implementation of the SCP in daily     clinical practice. The purpose of this study is to assess the impact of SCP care in routine     clinical practice on cancer survivors' satisfaction with information disclosure and care,     quality of life, illness perception, and health care use.   "
160280|NCT01185613|"     The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by     documenting the procedural parameters, major complications and recurrence of AF after     ablation using Cool Flex ablation catheter for the treatment of paroxysmal atrial     fibrillation.      This study is an observational clinical study which is not based on any specific endpoints.   "
160281|NCT01185600|"     INTRODUCTION. Cell-derived microparticles (MP) are released in cell activation, apoptosis and     other processes. MP derived from red cells (RMP) are known to be released from stored packed     red blood cells (PRBC), and their number increases with storage time. This constitutes one     aspect of the storage lesion. Adverse transfusion events are known to increase with time of     PRBC storage. The explanation for this is not known.      HYPOTHESIS. Based on their findings and those of others, the investigators propose to test     the hypothesis that MP in stored PRBC contribute to adverse effects of transfusion.     Specifically, MP in stored blood: (1) increase procoagulant activity, expression of     pro-inflammatory mediators, immune suppression, and endothelial disturbance; and (2) increase     the risk of transfusion and post-operative complications in patients undergoing coronary     artery bypass grafting (CABG).      AIMS & PROCEDURES. The aim of this study is to assess the clinical significance of MPs in     PRBC-related transfusion complications utilizing washed PRBC. Packed red blood cells (PRBC)     will be washed at the blood bank to obtain MP depleted PRBC (PRBC-MP). A total of 500     patients undergoing CABG will be initially randomized to 2 groups: one to receive PRBC-MP,     and the other conventional PRBC (PRBC+MP). Using a panel of lab tests/biomarkers selected for     high sensitivity the investigators will compare the 2 groups with respect to subclinical     physiologic host responses including (i) endothelial disturbances, (ii) inflammatory, and     (iii) procoagulant responses. In addition, clinically evident transfusion complications and     short term (<=30 days) surgical complications will be assessed and compared. Patients who are     randomized but end up not requiring transfusion at surgery will serve as controls. Laboratory     and clinical results will also be evaluated to elucidate which tests are significantly     associated with clinically adverse effects.      SIGNIFICANCE. This study will shed new light on the biochemical and clinical effects of     transfusion of MP. The findings of this investigation could significantly improve transfusion     practice and safety.   "
160294|NCT01185431|"     This trial is being conducted to look for following changes when fig paste is taken by female     subjects with functional constipation:      To evaluate the improvement of the bowel      To assess the quality of life and impact on female reproductive function      To evaluate the influence on glucose, cholesterol, HDL-cholesterol, LDL-cholesterol   "
160295|NCT01185418|"     The aim of the study is to investigate the negative symptoms and cognitive function after     administration of antipsychotics in healthy volunteer.   "
160282|NCT01185587|"     The purpose of this research is to see if investigators can detect truncated mRNA splice     variants of the cardiac voltage-gated sodium (Na+) channel gene, SCN5A, in patients with a     weak heart (Heart Failure) with or without an implantable cardioverter-defibrillator (ICD)     and compare them to patients with a normal heart.      Hypothesis:        1. Patients with reduced left ventricular ejection fraction have increased abundances          truncated mRNA splice variants of the SCN5A gene, which portends to sodium channel          dysfunction and an increased risk for sudden cardiac death.        2. Patients with implantable cardioverter-defibrillator devices (ICDs) who have experienced          shock therapy have increased abundances of truncated mRNA splice variants of the SCN5A          gene compared to similar congestive heart failure patients who have not experienced          shock therapy.   "
160283|NCT01185574|"     This study will examine whether weekly vitamin D supplementation in women with significant     depressive symptoms and diabetes will exhibit improved mood and metabolic control. If     supplementation with Vitamin D is beneficial, it will be a simple and cost-effective method     for treatment. Women will be targeted since they have greater depression and worse metabolic     control than men with diabetes.   "
160284|NCT01185561|"     This proposal describes a small randomized study to determine whether usual medical care     (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for     diabetes alone. This program differs from other diabetes programs by focusing on the     management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes     self-care behaviors will be discussed and measured, but they are not the primary focus of the     intervention. The psychoeducational program will address: 1) education about how dysphoric     symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of     dysphoric symptoms using Cognitive Behavioral Therapy (CBT). Subjects will be randomized to     receive the group psychoeducational intervention or no additional treatment. All subjects     will receive UMC for diabetes.   "
160285|NCT01185548|"     The purpose of this study is to assess the effect of tasisulam as an inhibitor of CYP2C9,     using tolbutamide as a probe substrate. This study is comprised of three treatment periods,     and continued access in an extension period. Period 1 is 4 days in length. Periods 2 and 3     are approximately 28 days in length.   "
160286|NCT01185535|"     As reported, about 0.43% patients can not be intubated unevenly because of difficult airway     and 30% of the total death of anesthesia due to failed intubation. The difficult airway will     disturb the clinical treatment and even threaten the patients' life. But the present methods     for tracheal intubation during awake intubation can not provided ideal intubation condition.     In this study, the investigators will perform topical anesthesia with the nebulized 2%     lidocaine at 10L/min oxygen flow rate, and the observer's assessment of alert and sedation     (OAA/S) scale was controlled to 3-4 points by intravenous midazolam,propofol, and     remifentanil. Tracheal intubation was performed after topical anesthesia. The arterial     pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood     samples were taken to measure stress factor during intubation period.Intubation condition     score was assessed and the complications like local anesthetic toxicity, mucosa injury,     respiration depress were also recorded. Patients were asked whether they could recall the     events during intubation 24 hr after operation. The investigators aim is to evaluate the     effect of topical anesthesia with lidocaine nebulized by 10L/min oxygen flow rate during     awake tracheal intubation.   "
160287|NCT01185522|"     This prospective, observational study will assess the effect of RoActemra/Actemra     (tocilizumab) on fatigue in patients with moderate to severe rheumatoid arthritis who have an     inadequate response to disease-modifying antirheumatic drugs (DMARDS) or anti tumor necrosis     factor (anti-TNF) drugs. Eligible patients receiving RoActemra/Actemra according to the     standard of care will be followed for 4 months.   "
160288|NCT01185509|"     The purpose of this research study is to see what effects trastuzumab in combination with     vinorelbine has on breast cancer when the participant has circulating tumor cells that are     positive for the protein called HER2. Trastuzumab is an FDA approved drug that targets HER2.     The drug combination of trastuzumab and vinorelbine is an effective treatment for patients     with breast cancers that are positive for HER2. This trial seeks to determine if the     combination can also benefit participants whose original breast cancer was HER2 negative but     whose circulating tumor cells are HER2 positive.   "
160289|NCT01185496|"     The purpose of this study is to evaluate the safety and effectiveness of the G4 System when     worn for up to 7-days by children and adolescent subjects (6 to <18 years-old) with type 1     diabetes mellitus.   "
160290|NCT01185483|"     Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of     superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of     submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a     high degree of endoscopic skills to be performed safely, it is time consuming, and less safe     than endoscopic mucosa resection.      New endoscopic instruments have been developed to increase the efficacy and safety of ESD,     and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with     promising results in animal studies. This HybridKnife allows high-pressure water-jet     (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without     changing instrument.      The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for     ESD in humans.   "
160291|NCT01185470|"     • The objectives of this study are to confirm the medication delivery accuracy of the     Infusion System, LLC Implantable Drug Delivery System (IDDS) with Patient Controlled     Analgesia for intrathecal delivery of morphine sulfate for pain control, and to determine the     safety profile of the system with PCA for intrathecal delivery of morphine sulfate for pain     control.   "
160292|NCT01185457|"     The Left interscalene block has a different effect on heart's autonomic nervous system, as     measured with Heart Rate Variability, compared to Right interscalene block   "
160293|NCT01185444|"     Three weekly injections of hyaluronate (Hya-Joint) are safe and well tolerated, provide rapid     pain relief as early as 1 and 2 weeks after the first injection, and improve function in     patients with knee osteoarthritis. The treatment effects can last for 6 months.   "
160322|NCT01185054|"     The objective of this study is to clarify the current standard of care by determining if     Electrolyte Maintenance Solution (EMS) is truly the optimal fluid to be used in low-risk     children who present to an Emergency Department (ED) with < 72 hours of vomiting or diarrhea.   "
160296|NCT01185405|"     Voriconazole, a newer triazole-derivative, has become the drug of choice for many invasive     fungal infections, including invasive Aspergillosis. Recently, therapeutic drug monitoring of     voriconazole has been issued because of wide variations and unpredictability of voriconazole     blood concentration. The objective of this study is 1) to characterize the pharmacokinetics     of voriconazole in ICU patients on voriconazole prophylaxis or treatment, and 2) to develop     and evaluate the prediction and adjustment models for voriconazole plasma levels.   "
160297|NCT01185392|"     The European CRT survey represents a joint initiative between two ESC associations; the Heart     Failure Association and the European Heart Rhythm Association. The survey will be performed     in collaboration with The Institute für Herzinfarktforschung in Ludwigshafen which will     handle the data collection and data analysis.   "
160310|NCT01185223|"     The objective of this study is to assess the efficacy and safety of oral valganciclovir     versus intravenous ganciclovir in patients following allogenic stem cell transplantation.   "
160337|NCT01184859|"     This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group     comparative trial to be conducted in nocturia patients. The trial is designed to characterize     the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct     dose recommendations in the target patient population. In particular, the trial is designed     to link the duration of action to the clinical endpoint. Furthermore, the trial is designed     to describe the safety of four different dose levels of desmopressin.   "
160338|NCT01184846|"     The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects     with CIDP.   "
160391|NCT01184157|"     This study randomizes women using long-acting reversible methods of contraception to     home-based STD screening through the mail compared to screening available in a clinical     setting. We hypothesize that women randomized to home-based screening will be more likely to     complete screening.   "
160298|NCT01185379|"     Dietary intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs) is inversely associated     with cognitive decline and dementia (e.g. Kalmijn et al. 2004, Heude et al. 2003, Morris et     al. 2005, Dullemeijer et al. 2009). Recently, the effects of supplemental docosahexaenoic     acid (DHA) on behavioural outcomes in older adults has been explored, however two trials     addressing this issue have published conflicting results regarding the efficacy of DHA     supplementation, with one reporting a benefit of treatment on cognitive performance     (Yurko-Mauro et al. 2010), while the other did not (Dangour et al. 2010).      One area of research that has yet to be explored in this cohort is the effects of n-3 PUFAs     on brain function in physiological terms. It is also possible that n-3 PUFAs, in combination     with other compounds, may be more beneficial than treatment with n-3 PUFAs in isolation. The     current study will explore several separate hypotheses within the same cohort. These are that     Efalex Active 50+ may have a beneficial effect on:        -  Cognitive performance        -  Mental fatigue in response to cognitively demanding tasks        -  Self-reported mood/well-being        -  Task-related cerebral blood flow response      The proposed study therefore has two aims; the primary aim is to evaluate the cognitive and     mood/well-being effects of Efalex Active 50+, a dietary supplement containing a number of     potentially cognition enhancing components including DHA, phosphatidylserine, vitamin B12,     folic acid and Ginkgo biloba, compared with placebo in a sample of older adults aged 50-70     years (Cognitive Study). The second is to evaluate the cerebral haemodynamic effects of the     same treatment formulation in a sample drawn from the same population, with the addition of a     third DHA-only arm (Hemodynamics Study). The intervention period will be 6 months.   "
160299|NCT01185366|"     The goal of this clinical research study is to compare the effectiveness of Afinitor     (everolimus) and Sutent (sunitinib) for the treatment of advanced renal cell carcinoma     (kidney cancer). The safety of each treatment will also be studied.   "
160300|NCT01185353|"     The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants     with Rheumatoid Arthritis (RA).   "
160301|NCT01185340|"     The primary objective of this study is to assess whether LY2216684 12 mg to 18 mg flexible     dose once daily is superior to placebo Once Daily in the adjunctive treatment of patients     with major depressive disorder (MDD) who are partial responders to their Selective Serotonin     Reuptake Inhibitor Treatment (SSRI).   "
160302|NCT01185327|"     Nursing team of well baby nursery at Hillel Yaffe medical center in Hadera, Israel have     noticed that infant of Ethiopian-origin mothers regurgitate more than other infants.     Probably, these infants are breastfeed much more than other infants.      Some Ethiopian-origin mothers are used to eat teff-flower porridge during the last weeks of     pregnancy and after birth, in order to expand milk production.      Study goal is to find out if infants of Ethiopian-origin mother do regurgitate more than     others, and if they weight gain is similar to other infants. Another goal is to find out if     breastfeeding mothers of Ethiopian origin do eat that porridge, and if there is any     difference between those who do eat that porridge and those who do not.   "
160303|NCT01185314|"     The purpose of this study is to study the changes in protein in lung cells of Asian patients     with advanced non small cell lung cancer.   "
160304|NCT01185301|"     The purpose of this study is to determine the effects of different doses of methotrexate     (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).   "
160305|NCT01185288|"     This study will investigate the efficacy of both low and high doses of methotrexate (MTX) in     combination with open-label adalimumab (ADA) in patients who have had an inadequate response     to high dose of MTX. The study will also evaluate the pharmacokinetics and safety of the two     regimens of MTX in combination with ADA in participants with rheumatoid arthritis (RA).   "
160306|NCT01185275|"     Clinical response, as defined by improvement in asthma quality of life, to bronchial     thermoplasty in patients with severe refractory asthma can be predicted through the use of     clinical, physiologic, biologic and imaging markers.   "
160307|NCT01185262|"     The rationale for combining lenalidomide with rituximab derives from preclinical observations     suggesting that lenalidomide may enhance the ADCC (antigen-dependent cellular cytotoxicity)     triggered by monoclonal antibodies such as rituximab. Lenalidomide augments NK cytotoxicity     by increasing CD56dimCD3 subset, in addition to inducing IL-2 in T cells. These results     provide the cellular and molecular basis for the use of lenalidomide as an adjuvant in     immunotherapeutic strategies of monoclonal antibodies (mAb)-based therapies. The combination     lenalidomide-rituximab was tested in lymphoma cell lines but not specifically on CLL cell     lines. However the observed synergism was attributed to NK cells expansion, thus lending     support to the notion that this synergism may operate in other B-cell lymphoproliferative     malignancies.      The objective was to develop a non-cytotoxic and effective treatment for CLL that would     fulfill an unmet medical need, as a significant proportion of CLL patients are elderly and     frail. These patients experience an excess in chemotherapy induced toxicity, often preventing     the completion of the planned treatment.   "
160308|NCT01185249|"     Early morning weights to monitor CHF patient's fluid status is common practice but there is a     lack of evidence that this is the best practice. The purpose of this study is to determine if     there is a difference in net weight gain or loss for hospitalized patients with CHF who are     weighed in the evening instead of early morning.   "
160386|NCT01184222|"     SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy of     great occipital nerve stimulation (GONS) associated with medication withdrawal in the     treatment of medication overuse headache occurring in migraine patients.   "
160309|NCT01185236|"     A single center, open label, randomized, clinical trial comparing ApoB/ApoA ratio of Vytorin     10/20mg vs atorvastatin 20mg treatment.      DM2 patients will be screened for inclusion criteria. Patients (n=66 in each arm) will be     randomized to either Ezetimibe/simvastatin 10/20mg or atorvastatin 20mg after 4 week washout     or TLC period. Primary and secondary endpoints will be assessed at week 12.      Primary endpoint:      1) change of ApoB/ApoA ratio at week 12.      Secondary endpoint:        1. Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.        2. Change of HbA1C at week 12.        3. Change of HOMA index at week 12           - HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5        4. Change of hsCRP at week 12        5. Safety assessment      Hypotheses:        -  Three months treatment of Vytorin 10/20mg will be superior to atorvastatin 20mg in          ApoB/ApoA ratio.        -  In DM patients, Ezetimibe/Simvastatin Combination will be well-tolerated.   "
160311|NCT01185210|"     Background:      Over the past few decades, fructose is increasingly being used as a sweetener/ additive in a     variety of foods. Incomplete absorption of fructose has been implicated as a cause of     gastrointestinal symptoms. In tertiary care centers, the prevalence of fructose malabsorption     in subjects with unexplained GI symptoms is thought to be between 11-50%, when assessed with     breath tests following administration of 25 grams of fructose in a 10% solution. Restriction     of dietary fructose has been shown to improve symptoms in these patients to an extent.     Currently, there are no therapeutic agents that improve intestinal fructose absorption and     thereby decrease symptoms. Studies in the pediatric population have shown that fructose     absorption in the small intestine is increased in the presence of glucose or amino acids,     especially alanine.      Objective:      The investigators' objective is to assess whether co-administration of an oral solution of     L-alanine facilitates fructose absorption and decreases gastrointestinal (GI) symptoms     associated with fructose malabsorption in subjects undergoing standard fructose breath test     when compared to placebo.      Methods and analysis:      The investigators propose a randomized, double-blind study in 40 subjects with known fructose     intolerance. After an overnight fast, each subject will receive an oral solution of 12.5     grams of alanine in 125cc of water or placebo. Next, the subject will receive an oral     solution of 25 grams of fructose in a 10% solution. Serum, urine and breath samples will be     collected at baseline and at 30-minute intervals for 4 hours. GI symptoms will also be     assessed and recorded at 30 minute intervals using a standard questionnaire. Repeated     measures ANOVA will be used to compare the data obtained during the study protocol with the     baseline (pre-study) data.      Expected outcomes:      Co-administration of alanine with fructose may improve fructose absorption and decrease     symptoms in subjects with fructose intolerance.      Hypothesis: Ingestion of alanine along with fructose, will facilitate intestinal absorption     of fructose in subjects with fructose malabsorption.      Aim: To investigate the effects of co-administration of equi-molar doses of alanine on a) the     absorption of fructose and b) the occurrence of GI symptoms in subjects with fructose     malabsorption.   "
160312|NCT01185197|"     Study objective: To investigate the potential therapeutic efficacy of enteric-coated     mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for     minimal change nephrotic syndrome (MCNS).   "
160313|NCT01185184|"     This study will explore the drug behavior and safety following single dose of two 20     milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a     10 milligram immediate release tablet, using a 3 way crossover design.   "
160314|NCT01185171|"     The purpose of this study is to explore the activity of ZD1839 added to concurrent     chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck     cancer. Activity is described in terms of response rate (complete responses only).   "
160315|NCT01185158|"     The purpose of this study is to find out what effects (good and bad) ZD1839 has on one's     squamous cell head and neck cancer. The research is being done because currently no effective     treatment exists for metastatic (spread of cancer cells from one area of the body to another)     or recurrent squamous cell cancer of the head and neck. The purpose of this study is to find     out if ZD1839 can shrink tumors or cause tumors to stop growing for a period of time.   "
160316|NCT01185145|"     Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is     safe and effective in patients with early stage breast cancer resected by lumpectomy.   "
160317|NCT01185132|"     In the setting of radiotherapy as part of breast-conservation therapy for patients with early     stage breast cancer, the novel planning and delivery method of intensity modulated     radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal     external beam radiotherapy, spares more normal breast and lung tissue, and may lead to     improved clinical outcomes.   "
160318|NCT01185119|"     10 healthy men will be PET-scanned (CNS) twice in random order with infusions of placebo or     Native GLP-1 during hyperglycemic clamp to uncover the metabolic effects of GLP-1 in     perspectives of intervention of macrovascular late diabetic pathology such as stroke and AMI.     Earlier studies have revealed tendencies towards steady glucose metabolism in the CNS despite     fluctuations in blood sugar when infusing native GLP-1.   "
160319|NCT01185093|"     The main objectives of the study is to        -  Evaluate the knowledge acquisition and retention of 4th-grade students who participate          in the St. Jude Cancer Education for Children Program        -  To examine the relationship between outcome measures (knowledge acquisition and          knowledge retention) with covariates of interest such as self-reported age and gender        -  To compare the knowledge scores among schools and identify the schools that may show          better improvement than others and factors associated with improvement   "
160320|NCT01185080|"     The primary purpose of this study is to investigate effect, tolerability and safety of     different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis     patients out of season in an allergen challenge model.   "
160321|NCT01185067|"     Diastolic heart failure (also known as heart failure with normal ejection fraction or     heart failure with preserved ejection fraction) occurs even though the heart muscle's     pumping function is normal. In many cases diastolic heart failure is related to stiffening of     the heart and blood vessels in people who have high blood pressure. Current guidelines     suggest that patients should limit the salt content of their diet, as too much salty food can     cause fluid retention and other problems in diastolic heart failure. Studies in animals with     diastolic heart failure suggest that antioxidant chemicals found in grapes can block some of     the harmful effects of salty diets. Because it is often difficult for patients with diastolic     heart failure to maintain a low salt diet, the investigators are researching the effects of     the antioxidant properties of grape seed extract, a natural supplement made from grape seeds.     The investigators hypothesize that supplementing the diet with grape seed extract (GSE) can     decrease the levels of harmful chemicals and improve heart and blood vessel function in     patients with diastolic heart failure and a history of high blood pressure.      The University of Michigan research group plans to enroll 25 patients with a history of high     blood pressure and diastolic heart failure in a research study. The study will assess the     effects of GSE on hormones and other chemicals that can cause heart and blood vessel damage.     The investigators will also study the effects of GSE on the ability of the blood vessels and     heart muscles to relax at the proper time and speed. Finally, the investigators will observe     how GSE affects participants' overall ability to exercise, quality of life, and blood     pressure control. Study participants will be randomly assigned to take either GSE or placebo     (looks like but does not contain GSE) capsules twice a day for six weeks. After a two-week     break, all subjects will cross over to the opposite group of capsules for an additional     six-week period. At the start of the study and at the end of each six-week time period study     participants will have non-invasive heart and blood vessel testing, blood work and urine     tests, and blood pressure monitoring.   "
160387|NCT01184209|"     Prospective study to evaluate incidence, causes and potential risk factors for adrenal crisis     in patients with chronic adrenal insufficiency.   "
160334|NCT01184898|"     The purpose of this study is to evaluate the addition of Sirolimus (rapamycin) to standard     chemotherapy for the treatment of patients with high risk acute myelogenous leukemia (AML).     Cancer cells taken from the patients will be studied in the laboratory to see if rapamycin is     affecting the mTOR pathway in the cells and if this effect is correlated with how well     patients respond to the therapy.   "
160335|NCT01184885|"     This is a pilot study, assessing the feasibility, safety and toxicity of an mTOR (mammalian     target of Rapamycin) inhibitor (MTI), rapamycin, when administered with HyperCVAD     (Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicine and Dexamethasone), with an     ultimate goal to perform a phase II study to evaluate response rates and survival in adults     with Acute Lymphoblastic Leukemia (ALL) and aggressive lymphoid malignancies.   "
160336|NCT01184872|"     The purpose of this study is to provide data documenting the efficacy of daptomycin in     elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.   "
160787|NCT00000224|"     The purpose of this study is to evaluate buprenorphine blockade challenge.   "
160323|NCT01185041|"     Increased abdominal obesity (waist circumference) and systolic blood pressure (BP) are main     risk factors for the metabolic syndrome. Approximately 60% of adults in the United States are     prehypertensive or hypertensive. Hypertension has been associated with abnormal endothelial     and autonomic function, the two main mechanisms of BP regulation. Endothelial dysfunction, as     a result of reduced NO (a vasodilator), and increased sympathetic nervous system activity     contribute to arterial stiffness by enhancing the vasomotor tone. Because BP variations are     sensed by baroreceptors in the wall of large arteries, increased stiffness of arteries may     attenuate the control of BP by the autonomic nervous system leading to hypertension. High     production of proinflammatory cytokines and low adiponectin (vascular protective molecule),     are considered the underlying mechanisms leading to endothelial dysfunction and arterial     stiffness. The recommended intervention for controlling BP in overweight/obese individuals     with pre- and stage 1- hypertension is lifestyle modifications and not drug therapy. Among     the dietary regimens that are reported to reduce BP is L-arginine, the substrate for     endothelial NO production. Recently, oral L-citrulline has been shown to be more effective     than L-arginine in improving circulating NO levels because is not affected by enzymatic     degradation. Watermelon, the leading US melon crop, is one of the few natural foods rich in     L-citrulline which is efficiently transformed to arginine in humans. The investigators     long-term goal is to provide feasible and effective dietary ways to reduce cardiovascular     risk factors in individuals with high abdominal fat and BP. The overall objective of this     study is to bring forth evidence that watermelon supplementation will reduce BP and     cardiovascular risk factors such as arterial stiffness, autonomic dysfunction and endothelial     dysfunction. The investigators postulate that watermelon supplementation will reduce BP and     arterial stiffness by enhancing endothelial function and reducing vascular inflammation. The     findings of this study will provide a foundation for disseminating feasible, safe approaches     for preventing and combating obesity-related hypertension at its early stage which does not     require drug therapy.   "
160324|NCT01185028|"     Background:        -  Chronic hepatitis C (CHC) is a major health problem that particularly affects          individuals with human immunodeficiency virus (HIV) infection, and can lead to cirrhosis          and liver failure. Standard treatment for people with HIV and CHC is a 48-week course of          pegylated-interferon alfa 2a (peg-IFN) and ribavirin (RBV), but better treatments are          needed for those who either do not respond to the drugs or who relapse after treatment.        -  Nitazoxanide has been approved by the Food and Drug Administration primarily to treat          diarrhea caused by parasites, and it has been studied in the treatment of CHC infection.          However, it has not been tested in persons infected with HIV and CHC co-infection.          Researchers are interested in determining whether nitazoxanide is a safe and tolerable          treatment for CHC in individuals with HIV.      Objectives:      - To assess the safety and tolerability of using nitazoxanide to treat chronic hepatitis C     infection in individuals with HIV who have not responded to standard treatment for hepatitis     C.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with both HIV and chronic     hepatitis C, and who have either not responded to or relapsed after previous hepatitis C     treatment.      Design:        -  Participants will be screened with a physical examination and medical history; blood and          urine tests; imaging studies; possible heart, lung, and psychological tests; and a liver          biopsy if one has not been done in the past 3 years.        -  Participants will receive nitazoxanide, the medication being studied, to take by mouth          for 4 weeks, and will provide blood samples during this time.        -  After 4 weeks, participants will receive the first dose of peg-IFN and RBV. Participants          will have weekly injections of peg-IFN and continue to take nitazoxanide and RBV by          mouth for 48 weeks. Individuals who are slow to respond to this combined CHC treatment          (nitazoxanide, peg-IFN, and RBV) by week 12 will continue to have the combined treatment          for an extended period, a total of 72 weeks.        -  Participants will have study visits to provide blood samples and have other tests two          times in the first month of combined treatment, and then at months 2, 3, 4, 7, 10, 13,          19; and month 25 only in participants slow to respond to combined treatment.        -  Some participants who are on specific HIV treatment regimens may enroll in a substudy          that will require three separate 12-hour visits for repeated blood samples and other          tests during the initial 4-week nitazoxanide treatment.   "
160325|NCT01185015|"     The multi-centric, open label, single arm and self controlled study is planned to assess the     efficacy of orally administered Sigmart in subjects with recurrent angina after coronary     revascularization. The primary objective of this study is to demonstrate that orally     administered Sigmart can improve the major Exercise Tolerance Test (ETT) result in recurrent     angina subjects.   "
160326|NCT01185002|"     The purpose of the study is to test the effect of a bowel preparation and boosts regimen on     PillCam® procedure, colon cleanliness and capsule excretion time.   "
160327|NCT01184989|"     To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on     coagulation parameters, including a calibrated thrombin time test, in patients with moderate     renal impairment undergoing elective total hip- or knee-replacement surgery, this PK/PD study     will be conducted.   "
160328|NCT01184976|"     Research Hypothesis: VGX-3400 (DNA plasmids encoding the hemagglutinin (HA), neuraminidase     (NA), and M2e-NP antigen of the H5N1 avian influenza virus) administered to healthy adult     males by IM injection followed by EP will be generally well tolerated and immunogenic.   "
160329|NCT01184963|"     The objective of this study is to assess the effects of a high protein (HP) and a normal     protein diet (NP) on patients with polycystic ovary syndrome (PCOS) and body mass index     (BMI)-matched controls in a sample of southern Brazilian women.      Patients will be randomized to receive high protein (30% protein, 40% carbohydrate, 30%     lipid) or normal protein (15% protein, 55% carbohydrate, 30% lipid) during eight weeks.      The investigators hypothesis is that a different diet composition may have influences in     changes of the main characteristics of PCOS, like hyperandrogenism and metabolic syndrome.   "
160330|NCT01184950|"     The use of virtual reality simulation training in obstetrics and gynecology has not been     widely studied. The investigators hypothesized that residents randomized to the trainer would     not perform differently when compared with those who are not randomized. Residents in     Obstetrics and gynecology are randomized to a 4 month training course on our simulator. They     are objectively evaluated performing various laparoscopy tasks prior to and after the course.   "
160331|NCT01184937|"     For patients with end-stage kidney disease, transplantation is the treatment of choice,     offering improved quality of life by restored metabolism and freedom from dialysis. However,     demands regarding the acquirement of knowledge in life post transplantation are high. In     order to reduce rejection episodes, graft loss and the negative consequences of life-long     immunosuppressive medication, it is essential for kidney recipients to possess knowledge     about important aspects regarding immunosuppressive medication, graft surveillance and the     benefit of specific lifestyle behavior. Consequently, patient education is required for this     patient group. This randomized controlled trial is investigating the effect of a structured     patient education program on kidney recipients' knowledge, coping and quality of life   "
160332|NCT01184924|"     The primary goal of this study is to assess the effectiveness and feasibility of the     arthritis foundation (AF) Tai Chi Program for People with Arthritis. Arthritis, the most     prevalent chronic condition in the US and a leading cause of disability, is characterized by     chronic pain and progressive impairment of joints and soft tissues. Promoting physical     activity is a key public health strategy to addressing arthritis management, but more     scientific data regarding effectiveness and feasibility are need to support the promotion of     the AF Tai Chi Program as an exercise intervention for people with arthritis.   "
160333|NCT01184911|"     The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in     pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by     increased SP resistance. This study will evaluate the efficacy of SP by giving SP to     asymptomatic parasitemic pregnant women and following them to determine the rates of parasite     clearance.   "
160339|NCT01184833|"     Non-adherence to the treatment regimen is a common problem associated with injectable drugs     (e.g. Betaferon) that are used in multiple sclerosis patients.      Certain patients omit single injections or even totally discontinue therapy that normally     should be long-term. It is therefore crucial to identify the factors which have the most     significant effect on regularity of administration of Betaferon and the risk of premature     discontinuation of treatment in order to undertake appropriate preventive measures.      This study is conducted in routine practice setting and aims to identify those risks.     Pre-defined risk factors associated with technical aspects of the treatment, support provided     to the patient, stage of the disease and possible adverse effects of the medication are     checked on a quarterly basis with a questionnaire method. Monitoring of omitted doses of the     prescribed medication (Betaferon) is carried out by the study nurse.   "
160340|NCT01184820|"     The purpose of this study is to describe the pharmacokinetics (PK) of BAY94-9027(the test     drug). Pharmacokinetics means that we will measure how well the study drug corrects the     factor VIII levels in your blood and how long it takes for the levels to fall back to your     baseline level. The study is also designed to determine if the pharmacokinetics of BAY94-9027     change following repeat dosing over 8 weeks, determine if BAY94-9027 is safe, tolerable, and     effective for the treatment of severe hemophilia A and define the appropriate dose of     BAY94-9027. Two doses of BAY94-9027 will be studied.      The first 8 subjects enrolled in the study (cohort 1) will receive a low dose (25 IU/kg) and     will be treated 2 days a week for 8 weeks (total of 16 doses). The second 8 subjects (cohort     2) will receive a higher dose and will be treated 1 day a week for 8 weeks (total 8 doses).     All subjects will receive a single dose of rFVIII (Bayer Kogenate FS) to determine the PK by     measuring blood levels for 2 days before they start the study drug BAY94-9027. Factor VIII     blood levels for BAY94-9027 will be measured for 7 days after the first and last dose to see     describe the PK. Safety & tolerability assessment include vital signs, coagulation and     hematological parameter, clinical chemistry, measurement of FVIII inhibitor and polyethylene     glycol (PEG) antibodies will be done during the course of the study.   "
160341|NCT01184807|"     This is an open-label, non-randomized, dose-escalation trial in patients with advanced solid     tumors. The trial comprises 2 stages: a dose escalation stage at 8 dose levels of 2, 5, 10,     20, 40, 60, 80, and 100 mg/day,and possibly additional intermediate doses, to determine the     MTD and recommended dose, and a subsequent 2 parts of expansion stage to investigate the     safety profile and antitumor effect of OPB-51602 at the recommended dose.   "
160342|NCT01184794|"     This study is a blinded randomised study of slow release levobupivacaine vs saline for women     undergoing day case operative pelvic laparoscopy. Participants will be randomly given either     saline or levobupivacaine and efficacy will be measured using ranked ordinal pain scales and     rescue oral analgesia use.   "
160343|NCT01184781|"     The aim of the study is to perform a prospective, multicenter research comparing capsule     endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer     specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic     accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and     a high resolution colonoscope (with high definition). Both procedures will be perform in the     same day with an adapted bowel preparation.   "
160344|NCT01184768|"     Following the 6th Tromso study subjects with HbA1c > 5.7 plus a subsample of subjects with     lower hba1c values will be invited to an oral glucose tolerance test to see the predictive     value of HBA1c in the diagnosis of type 2 diabetes.   "
160345|NCT01184755|"     Our aim is to conduct a randomized controlled trial (RCT) to test the efficacy of a guided     breathing intervention on ambulatory blood pressure (ABP), both systolic and diastolic BP.     There are 3 groups: 1) Intervention group instructed to use the RESPeRate device that guides     the breath into the 6 breaths/minute range daily for 8 weeks. 2) Relaxation control condition     (using a modified device to guide breathing at 13 breaths/minute rate); and 3) Usual Care     (UC). After the initial 8 week trial, the main outcome, the intervention group will be     randomly assigned to stop using the RESPeRate device or to continue using it for 8 more     weeks.   "
160346|NCT01184742|"     The purpose of this study is to assess the relationship between physical fitness and     wheelchair mobility capacity and 1) participation; 2) self-reported environments barriers;     and 3) self-reported avoidance of environmental features.   "
160347|NCT01184729|"     The goals of this project are to 1)determine the responsiveness of the 6 Minute Push Test     (6MPT) and 2) explore the relationship between 6MPT distance and measures of handicap,     wheelchair satisfaction, depression, and self-reported avoidance of environmental features.   "
160764|NCT00000201|"     The purpose of this study is to conduct human laboratory studies of possible cocaine     interactions with various potential treatment medications.   "
160348|NCT01184716|"     Approximately 200 families corresponding to 800 persons are included in the study. The study     investigate the efficacy of vitamin D fortification of bread and milk on vitamin D status in     serum. Participants receive milk and bread twice a week. Half of the participants receive     vitamin D fortified products and the other half similar non-fortified products. The study     starts in September and runs for 6 months during winter, the period where it is not possible     to produce vitamin D in the skin through sunlight exposure. The hypothesis is that the usual     fall in vitamin D status can be prevented by vitamin D fortified food.   "
160349|NCT01184703|"     The purpose of this study is to investigate if a low glycemic index diet in comparison with a     medium/high glycemic index diet improves the metabolic control in patients with type 1     diabetes.   "
160350|NCT01184690|"     Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout     the entire small intestine. Although the originally described method requires two operators,     the investigators have recently developed a method to perform DBE by a single operator. The     investigators here assessed the clinical usefulness of this one-person method in comparison     to the conventional two-person DBE.   "
160351|NCT01184677|"     The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would     reduce the incidence of mucosal injury.   "
160373|NCT01184391|"     The objective of this study was to investigate the bioequivalence of Mylan's divalproex     sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following     a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.   "
160352|NCT01184664|"     Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation     treatments. Anecdotally smokers who are finding their quit attempt difficult have reported     benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled     double-blind study will examine whether combining NRT and varenicline provides better     withdrawal and craving relief than varenicline alone. A total of 120 smokers would be     randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All     participants will receive standard NHS Stop Smoking Service support. The primary outcome     would be ratings of craving and withdrawal discomfort 24 hours and one week after the target     quit date.   "
160353|NCT01184651|"     The goal of this study is to help investigators to understand more about the development of     characteristics related to being male or female (what is called gender development). The     investigators will study girls with congenital adrenal hyperplasia (CAH) aged 10 to 13 to     learn more about the girls' interests and activities, thoughts and feeling about being     female, and family relationships. This will help investigators to understand the ways in     which gender development is shaped by hormones and family relationships.   "
160354|NCT01184638|"     Cognitive disorders in patients underwent general anesthesia are discussed for decades, but     whether there were precise relationship between general anesthesia and dysgnosia is yet to be     guaranteed. Although controversial data reported from experimental studies in animals, the     investigators still proposed that general anesthetics could impair the normally organized     system of the central nervous system, which finally displayed a dysfunction of cognition     after general anesthesia in a short- or long-term period. Therefore, different types of     general anesthetics such as inhalational anesthetics and intravenous anesthetics, the     investigators hypothesized, had a long-term influence on patients' cognitive ability.   "
160355|NCT01184625|"     The objectives of this study are to test if hypoxia in muscle tissue is an important factor     contributing to clinical symptoms in chronic rheumatic muscle inflammation and to evaluate if     a 12 week endurance exercise program will improve muscle tissue hypoxia and disability in     patients with chronic rheumatic muscle inflammation.   "
160356|NCT01184612|"     Motivational Interviewing (MI) is a communication style demonstrated to decrease drug and     alcohol use. A five session MI intervention (BSF) was implemented in the Swedish correctional     system. The intervention was delivered by counsellors with workshop only MI training (BSF) or     by counsellors with workshop MI training followed by peer group supervision based on audio     taped feedback (BSF+).      Aim was to examine whether BSF in prisons reduces drug and alcohol use more effectively than     interviews conducted according to the usual planning interview routine (UPI).   "
160357|NCT01184599|"     The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin     inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA     nephropathy.   "
160358|NCT01184586|"     Dupuytren's disease is a progressive disease due to unknown causal agents or genetics.      Dupuytren's disease contains nodules and cords in the fascia as the epicenter of disease     progression. Nodules contain whorls of collagen bundles and are densely packed with     contractile fibroblasts and myofibroblasts. These highly contractile cells are linked to the     fascia matrix through transmembrane integrin receptors. The cytoplasmic tail domains of the     alpha beta integrin receptors provide a structural link between extracellular matrix and the     actomyosin cytoskeleton.      Complications of surgical partial or total aponeurectomy in Dupuytren's disease are reported     in up to 10% of cases . Often, surgical complications lead to compromised flexion limiting     grasping function of the involved hand . A recent 20-year-review of the literature included     41 clinical trials with complication rates reported from 3.6%to 39.1% . 16% major     complications occurred with 3% digital nerve injuries, digital artery injuries in 2%,     infections in 2%, and complex regional pain syndrome in 6%. Besides selective or total     aponeurectomy, soft-tissue distraction has been suggested using either pneumatic devices or     external fixateur .      Non-invasive options include percutaneous fasciotomy or collagenase injection. The latter has     been tested in a randomized-controlled trial published in the New England Journal of Medicine     with 308 patients enrolled (NCT00528606) . Collagenase clostridium histolyticum significantly     reduced contractures and improved the range of motion in joints affected by advanced     Dupuytren's disease. In the long-term the cords at the level of the proximal interphalangeal     joint appear to more recurrent than at the metacarpophalangeal joint after collagenase     injection with an eight year follow-up .      In early stage Dupuytren's contracture, radiotherapy has been suggested to limit disease     progression. A cohort study of 135 patients with 208 hands involved received orthovoltage     radiotherapy with a total dose of 30Gray separated by a six to eight week interval . After a     follow-up of 13 years nodules and cords remained stable in 59%, improved in 10% and     progressed in 31%.      Beside Dupuytren's disease, there are a number of further less common fibromatosis, such as     knuckle pads, M. Ledderhose , of the plantar fascia and peyronie disease at the penis. The     latter has been treated by extracorporeal shockwave therapy. A randomized-controlled trial     using 2000 focused shock waves reduced pain significantly and improved erectile function and     quality of life . About half of the patients in one series of 44 patients had a significant     reduction in angulation following shockwave therapy .   "
160359|NCT01184573|"     The goal of this study is to evaluate the feasibility of using a non-invasive,     non-radioactive Pancreatic Breath Test (PBT) as a diagnostic tool to detect early stages of     chronic pancreatitis (CP). If successful, this method could have important advantages over     existing diagnostic tests for detecting early stage CP. This diagnostic breath test may have     a clinical impact if it leads to early detection of CP and intervention to mitigate disease     progression.   "
160497|NCT01182740|"     The investigators will compare the success rates of endotracheal intubation in a simulated     entrapped car accident victim (manikin) using different video laryngoscopes by experienced     emergency physicians.      The investigators hypothesized that video laryngoscopes may improve success rates.   "
160360|NCT01184560|"     The purpose of this study, conducted academic Pilot research purposes, this is not clear as     to permit. when orlistat to sibutramine merge if there are additional effects of BMI and     group, which has an attribute that is greater for the combined effect is to analyze.        -  Study phase: Investigator-initiated clinical study (Pilot study)        -  Method of blinding: Double-blind        -  Control: Placebo-controlled        -  Assignment method: Randomization (Sibutramine monotherapy group: Orlistat and          Sibutramine combination group = 1 : 1)        -  Studied disease: Obesity        -  Study population: Subjects eligible for inclusion/exclusion criteria        -  Dosing period: Total 18 weeks Run-in period (2 weeks), dosing period (12 weeks) and          post-dosing observation period (4 weeks)   "
160361|NCT01184547|"     The purpose of this proposal is to assess the efficacy of implementing a 12-week structured     and supervised community-based exercise program (COMBEX) at hospital discharge. The     investigators will assess the effect of exercise on mental health and physical function,     along with its effects on the amelioration of the burn-induced catabolic response.      The central hypothesis of this proposal is that exercise-induced physical and psychosocial     benefits obtained during a supervised and structured COMBEX program in severely burned adults     will improve physical function, and quality of life relative to Standard of Care (SOC).   "
160362|NCT01184534|"     Objective:      To compare changes in patient anxiety levels between groups of patients who either were or     were not exposed to an informative multimedia patient education tool, in order to determine     how the addition of such a multimedia tool will affect this parameter. Specifically, the     study will focus on subjective anxiety as measured on pre procedure and post procedure     patient surveys as detailed under study components.   "
160363|NCT01184521|"     This is a study to evaluate the accuracy of the Masimo Rainbow SET Pulse CO-Oximeter in     monitoring the hemoglobin levels of patients undergoing isovolemic hemodilution.   "
160364|NCT01184508|"     The primary objective of this study is to measure the change in frequency of migraine attacks     per 28 days in migraine patients being treated orally with LY2300559 for 12 weeks.   "
160365|NCT01184495|"     A double-blind, randomized trial aimed to compare the efficacy of two formulations of     erythropoietin in patients with chronic renal failure on hemodialysis   "
160366|NCT01184482|"     This trial is for patients with colon cancer, head and neck cancer and lung cancer that has     not responded to standard therapy.      Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or     EGFR. It is thought that this receptor is turned on in some cancers, enabling cancer cells     to divide and grow. Blocking this receptor can turn this signal off. Cetuximab blocks this     receptor from the outside of cancer cells. It is thought that cancer cells can turn this     signal back on by the EGFR joining with a related receptor called ErbB2. Lapatinib blocks     both EGFR and ErbB2 from the inside of cancer cells. In laboratory experiments it has been     found that combining drugs that target both EGFR and ErbB2 might work better in turning this     signal back off. The purpose of this study is to determine the maximum dosages that patients     can tolerate when these two medicines are given at the same time.      In addition, in order to be on this trial, patients must agree to have a tumor biopsy before     starting treatment on this study and 21 days after starting treatment. These biopsies are a     required part of the study. Patients must also agree to have blood drawn for research testing     to see whether genetic differences between patients explain different reactions to and side     effects from, these medicines.   "
160367|NCT01184469|"     The purpose of this study is to prospectively define a set of data suitable for developing     models of pregnancy viability. Those models will be based on serum hCG concentration measured     during the peri-implantation period in patients that received fresh embryo transfer and those     that received transfer of frozen-thawed embryos, and to compare and contrast these models.     This may reveal insights into differences between these types of IVF cycles.   "
160368|NCT01184456|"     Improvement in the rate of bacterial translocation may lead to a decrease in a chronic     inflammatory response thereby decreasing CD4 destruction and HIV proliferation.      By the addition of probiotics we hope to show a reduction in LPS leading to a decrease in     chronic inflammation and therefore an improvement in immune markers.   "
160369|NCT01184443|"     The purpose of this trial is to evaluate the safety and efficacy of the atypical     antipsychotic, olanzapine, for the treatment of youth suffering from Anorexia Nervosa (AN).      Adolescent males and females between the ages of 11 and 17 years who are being treated by a     physician on the Eating Disorder team at the Children's Hospital of Eastern Ontario will be     invited to join the study if they have been diagnosed with AN or Eating Disorder Not     Otherwise Specified (EDNOS), and if they weigh less than or equal to 85% of their ideal body     weight. Those who meet inclusion and not exclusion criteria, and consent to participating in     the trial will be offered adjunctive treatment with olanzapine. Those who agree to take     olanzapine will belong to the olanzapine group, and those who decline will belong to the     comparison group. Olanzapine doses will be in keeping with the investigators current clinical     practice, with flex doses ranging from 1.25 mg to 10.0 mg daily (the majority of patients are     treated with 2.5 mg or 5.0 mg at bedtime); dose adjustments made based on individual need and     tolerability. Participants will remain in the study for 12 weeks. Those who initially decline     olanzapine treatment may change their minds and take olanzapine up until week 9 of the trial.      It is hypothesized that those children and adolescents who choose to take olanzapine at entry     into the trial will be more motivated to recover and more compliant with treatment. Compared     to those who do not receive medication, it is expected that these adolescents will     demonstrate reduced disordered eating attitudes and behaviours, as well as an increased rate     of weight gain.      Finally, it is predicted that the rates of discontinuation and the adverse effects of     olanzapine will be minor given the relatively low dose (as compared to treatment for patients     with schizophrenia), slow titration, and short-term use of olanzapine the investigators will     be using.      By comparing the well-being and outcome of patients in the two groups, the investigators hope     to begin to answer the question of whether olanzapine does or does not lead to improved     clinical outcome for patients with severe eating disorders such as AN or EDNOS, and the     question of whether the benefits of using the medication outweigh the risks.   "
160370|NCT01184430|"     Cardiac surgery patients have a high risk to suffer from postoperative infections. Some     studies have shown, that humoral and cellular factors are associated with perioperative     immunodysfunction and can increase the risk of postoperative infections. Monocytes in the     blood and, especially alveolar macrophages are important for an adequate host defence. In     studies the investigators have shown that hemodynamic parameters have a significant influence     on the probability to develop postoperative infections. The aim of the study is to     investigate, whether cardiac surgery patients have an altered immune function after surgery     that is predictive for the latter development of subsequent infections and whether they     benefit from a goal-directed volume and hemodynamic therapy.   "
160371|NCT01184417|"     Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based     alcohol withdrawal protocol will be associated with decreased need for ICU admission,     continuous lorazepam infusion and will not be associated with increased adverse events.   "
160372|NCT01184404|"     Cardiac surgery relieves symptoms and increases life expectancy in cardiac patients, with and     without congenital heart disease (CHD). However, cardiac surgery involves many risks of     complications, such as bleeding, arrhythmias, and death.Right ventricular failure is another     complication, contributing to poor clinical outcome. Right ventricular failure is a clinical     syndrome, often difficult to treat, characterized by edema, elevated jugular venous pressure,     oliguria, hypotension, and in severe cases shock, multi organ failure and death. Patients     with CHD and patients with mitral valve lesions are suspected to be at increased risk for     developing right ventricular failure post-operatively. In addition, other clinical factors     contributing to right ventricular failure are mechanical pulmonary ventilation, pulmonary     hypertension and cardiac surgery. Right ventricular failure during cardiac surgery is caused     by the cardiopulmonary bypass by reperfusion with high partial pressures of oxygen, air     embolism, and the release of cytokines. The endothelin-1 cytokine induces vasoconstriction of     the pulmonary arterioles resulting in right ventricular afterload elevation. Treating     patients with an endothelin-1 receptor antagonist might improve clinical outcome post     operatively by decreasing right ventricular afterload   "
160375|NCT01184365|"     Fatigue is a common complaint of persons with spinal cord injury (SCI) that negatively     affects physical function, participation in daily activities, employment, and community     involvement. No behavioural intervention for fatigue has been reported for SCI, though the     benefits of such programs have been proven in persons with neurological conditions like     multiple sclerosis and arthritis. Based on a study with people with SCI, an energy management     program (EnMP-1) was developed. The focus of this study is to test EnMP-1. Adults with SCI     living in the community and reporting fatigue as a problem will participate in the program.      Hypothesis: Participants in the EnMP-1 group will show significantly lower fatigue impact     scores and higher self-efficacy scores immediately after, 3 months, and 6 months     post-intervention than EnMP-2 participants.   "
160376|NCT01184352|"     The objective of this Registry is to demonstrate the utility of the Glider PTCA Balloon     Catheter for crossing during the treatment of coronary artery disease.   "
160377|NCT01184339|"     Direct in-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and     methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's     bacteriophage-based diagnostic platform, two gold-standard reference methods, and two     predicate devices with similar indications for use.   "
160378|NCT01184326|"     This research study is evaluating the combination of pazopanib and everolimus in patients     that have a malignancy that is metastatic or unresectable and for which standard curative or     palliative measures do not exist or are no longer effective, or metastatic or locally     advanced unresectable kidney cancer. In this research study the investigators are testing the     safety of the combination of pazopanib and everolimus as well as to find the appropriate dose     to use for further studies.   "
160379|NCT01184313|"     The purpose of this prospective, randomized clinical trial is to understand and measure lung     injuries caused by CPB in aortic valve surgery.      Study questions:        -  Is there any correlation between the release of pro-inflammatory biomarkers and lung          injury degree?        -  Is there any correlation between oxyhaemodynamic parameters and lung injury degree?        -  Is there any correlation between oxyhaemodynamic parameters and the release of          pro-inflammatory biomarkers?        -  Are budesonide, erdostein and acetylcystein effective in the prevention of lung          injuries?   "
160380|NCT01184300|"     The objective of the RAPID GENE study is to evaluate the feasibility, efficacy and safety of     a pharmacogenomic approach to anti-platelet therapy following coronary artery stenting using     a CYP2C19*2 point-of-care genetic test.   "
160381|NCT01184287|"     The purpose of the trial is to determine the rate of improvement in objective tumor response,     following the addition of ranpirnase to ongoing pemetrexed—carboplatin chemotherapy, for     patients with SD or PR following 2 cycles of doublet chemotherapy.   "
160382|NCT01184274|"     This research is being done because SB939 has been shown to shrink tumours in animals and in     some people and seems promising, but we are not sure if it can offer better results than     standard treatment.   "
160383|NCT01184261|"     RATIONALE: Nicotine patches and behavioral therapy may help reduce cigarette smoking and     binge drinking in young adults. PURPOSE: This randomized clinical trial studies nicotine     patches with or without behavioral therapy in reducing cigarette smoking and binge drinking     in young adults.   "
160384|NCT01184248|"     The purpose of this study is to investigate if sound stimulation could improve pure-tone     hearing threshold.      In the late 1990s, researchers discovered that acoustic stimuli slow progressive     sensorineural hearing loss and exposure to a moderately augmented acoustic environment can     delay the loss of auditory function. In addition, prolonged exposure to an augmented acoustic     environment could improve age-related auditory changes. These ameliorative effects were shown     in several types of mouse strains, as long as the acoustic environment was provided prior to     the occurrence of severe hearing loss.      In addition to delaying progressive hearing loss, acoustic stimuli could also protect hearing     ability against damage by traumatic noise. In particular, a method called forward sound     conditioning (i.e., prior exposure to moderate levels of sound) has been shown to reduce     noise-induced hearing impairment in a number of mammalian species, including humans.      Interestingly, recent report has suggested that low-level sound conditioning also reduces     free radical-induced damage to hair cells, increases antioxidant enzyme activity, and reduces     Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically, increased     cochlear sensitivity was observed when distortion product otoacoustic emissions (DPOAEs) and     compound action potentials (CAPs) were measured.      In addition to forward sound conditioning, backward sound conditioning (i.e., the use of     acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing     ability against acoustic trauma and to prevent the cortical map reorganization induced by     traumatic noise.      Based on the results of animal studies, the investigators conducted a human study in 2007 and     observed that sound stimulation could improve hearing ability. On average, the pure-tone     hearing threshold decreased by 8.91 dB after sound stimulation for 2 weeks. In that study,     however, the investigators observed only the hearing threshold changes by sound stimulation.      To verify the previous ameliorative effect of sound stimulation, the investigators included a     control period in this study.   "
160385|NCT01184235|"     The study examines actigraphic, observational, psychometric and associated repeated     measurements obtained prior to and during psychopharmacological treatment.   "
160765|NCT00000202|"     The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in     treatment of opiate and cocaine dependence.   "
160388|NCT01184196|"     This study will enroll patients who will be receiving primary total knee replacements.     Subjects will be randomized into two groups: Betadine surgical scrub preparation and     ChloraPrep preparation prior to total knee replacements.      Study hypothesis: When used as a surgical scrub preparation prior to primary total knee     arthroplasties, ChloraPrep (2% chlorhexadine gluconate and 70% isopropyl alcohol) is superior     to Betadine (10% povidone iodine) in reducing incision site bacterial colony counts.   "
160389|NCT01184183|"     Carotid Endarterectomy (CEA), surgical removal of the blockage in the neck artery, is the     accepted management of choice for significant blockage of the carotid artery. Previous     studies showed improved perioperative outcomes and prevention of recurrent blockage by the     use of the patch to close the surgical incision in the artery. The ideal patch reduces     bleeding and prevents recurrent blockage.This is looking at long-term results toward     improvement with the use Accuseal patch than Bovine Patch.   "
160390|NCT01184170|"     The purpose of this study is to learn more about why some obese persons are resistant to     developing obesity-related metabolic diseases (such as diabetes and cardiovascular disease),     while others are prone to developing these conditions. We will do this by studying obese     persons before and after a 5% body weight gain.      Subjects will be asked to increase their current diet for a period of 8-12 weeks in order to     increase their current body weight by 5%. Each will then be asked to maintain this weight     increase for 3 weeks. We will monitor subjects throughout this time period with weekly     medical evaluations. At the completion of the study, we will provide each subject with a     6-month weight loss program.   "
160393|NCT01184131|"     The research proposed in this collaborative application Implementation and Evaluation of     Formal Training for Mentors of K-Series Mentored Career Development Awards will uniquely     study mentor training in the biomedical academic community. The randomized controlled trial     will be conducted at 15 Clinical and Translational Science Award sites over a 21-month period     with six months for baseline data collection, nine months for the intervention, three months     for follow-up, and three months for analysis. The multi-site trial will be conducted to     determine whether the resultant skills-focused, case-based, mentor training program can     improve the mentoring skills of K series mentors.   "
160394|NCT01184118|"     This study is being conducted to find out if the use of inhaled corticosteroids has an affect     on upper airway (UAW) collapsibility and sleep apnea risk. An inhaled corticosteroid is a     common asthma controller medication like Flovent. Sleep apnea or sleep deprived breathing     (SDB) is when someone stops breathing for a short period of time during sleep. For some     reason, people with asthma have more sleep apnea and upper airway (UAW) collapsibility     (weakness) than the general population. There are many possible reasons for this and one     might be related to the use of inhaled corticosteroids.      The overall hypothesis of this study is to determine whether inhaled fluticasone propionate     (FP) increases UAW collapsibility and to assess tongue (genioglossus muscle) dysfunction as a     potential underlying mechanism.   "
160395|NCT01184105|"     A phase I, single-center, double-blind, randomized, placebo-controlled, safety and     pharmacokinetic study to evaluate systemic and local vaginal exposure to lidocaine and     prilocaine and the metabolites, 2,6-dimethylaniline (2,6-DMA) and o-toluidine, in female     healthy volunteer subjects following daily application of 60 mg PSD502 or placebo to the     vagina and cervix for seven days   "
160396|NCT01184092|"     In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on     three separate occasions using one of three different tablet formulations (tablet versions)     each time. The amount of tasocitinib (CP-690,550) available in the blood following     administration of each tablet formulation will be measured and compared. The overall aim of     the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into     the blood following administration of the same dose of each different tablet formulation.   "
160397|NCT01184079|"     The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine     among males 18-24 years old, comparing an on-time administration of the third dose with     delayed administration of the third dose. All participants would receive the first and second     doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3     at 12 months.      Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the     usual timing control group (C):      H0: δ ≤ −δ0 versus H1: δ > −δ0 where δ = log (GMTT )− log (GMTC) and δ0 is the pre-specified     non-inferiority margin   "
160398|NCT01184066|"     The 5-year survival after a first diagnosis of breast cancer is 13% lower in black than in     white American women, an alarming disparity that cannot be explained by stage of disease at     presentation. Nonadherence to breast cancer treatment and treatment delays from diagnosis to     initiation of treatment may be among the reasons for worse breast cancer outcomes in black     women. This recognition is critical because it suggests that breast cancer survival disparity     can be decreased through clinical interventions that increase adherence to chemotherapy. The     ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime, intensive     psycho-educational intervention using a race-matched breast cancer survivor interventionist     to: address Attitudes, including perceptions and stressors, that may impact adherence to     clinical visits and treatment; encourage and model patient Communication with health care     providers regarding physical and emotional needs, with attention to race-discordant     situations; and provide tailored, understandable information about Treatment and its     rationale. The Support component is threaded throughout the intervention via the presence of     a race-matched breast cancer survivor and supportive video messages from the black community.     This study is a randomized controlled trial that will test the efficacy of the ACTS     Intervention vs. Usual Care on the primary outcomes of adherence to recommended breast cancer     chemotherapy.   "
160399|NCT01184053|"     The primary purpose of this study is to see whether women who have already received     chemotherapy for their endometrial cancer, or who have disease that has spread outside of the     uterus, will respond to the drug arsenic trioxide (Trisenox®) as judged by shrinkage of their     tumor.   "
160400|NCT01184040|"     Contingency Management (CM) is highly effective in promoting recovery from substance use     disorders, but benefits tend to attenuate over time when CM is discontinued. Identifying     modifications of CM delivery that can extend its benefits is an important goal. The goal of     this study is to evaluate the use of reinforcements to increase physical activity,     specifically walking. The study provides a standard CM intervention to promote walking for     three weeks. After three weeks, a progressively increasing variable interval schedule of     reinforcement will be evaluated for increasing the durability of effects of the initial CM     intervention. We hypothesize that Variable Interval Prize Contingency Management will result     in greater adherence to a walking goal of 10,000 steps per day at Week 15 and Week 24     compared to the Control Condition.   "
160401|NCT01184027|"     Weight loss resulting from poor food intake is common in head and neck cancer patients.     Currently, feeding tubes are placed before starting treatment to provide nutrition and     prevent weight loss. However, studies have not always shown that feeding tubes prevent weight     loss. Also, limiting food intake by mouth may lead to swallowing problems. The aim of this     study is to compare the effect of diet and swallowing therapy with feeding tube placement. In     this study, your weight, food intake, swallowing ability, and side-effects of treatment will     be monitored before, during, and 3 and 6 months after treatment to see if there is any     difference between the therapy groups. The investigators hope that with the addition of diet     and swallowing therapy during treatment that we can improve food intake and swallowing     ability while still maintaining weight.   "
160402|NCT01184014|"     The objective of this study is to determine the best insulin regimen for hospitalized     patients who receive high doses of steroids who have high blood glucose.   "
160512|NCT01182545|"     The investigators postulated that the use of hyperventilation after induction of anesthesia     before CO2 insufflation for laparoscopic surgery in Trendelenburg position would maintain     normocapnia and reduce the hemodynamic percussion response of CO2 insufflation.   "
160403|NCT01184001|"     In this study, a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy     subjects on two separate dosing occasions. On one occasion the tasocitinib (CP-690,550)     tablet will be administered in a fasting condition; On the other occasion the tasocitinib     (CP-690,550) tablet will be administered in a fed condition following a standard breakfast     meal. The amount of tasocitinib (CP-690,550) in the blood will be measured at various times     over 24 hours following each dosing occasion and compared to evaluate for any differences.   "
160404|NCT01183975|"     Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample     of centers representative of this activity in France.      Verification by means of a screening log (exhaustive list of all bariatric procedures     performed by participating surgeons between the beginning and end of the cohort inclusion     period) requested from all centers.      No comparator group. No randomization or blinding techniques   "
160405|NCT01183962|"     The purpose of this study is to evaluate the effect of Vitamin D supplementation on     cardiovascular disease and certain cells (T-regulatory cells) in the body that play a role in     plaque formation in arteries. This study will determine the levels of Vitamin D and     T-regulatory cells in subjects with coronary artery disease and if Vitamin D supplementation     will affect future events such as heart attach and stroke.   "
160406|NCT01183949|"     The purpose of this study is to determine whether AT7519M alone or AT7519M plus bortezomib     are effective treatments in patients with previously treated multiple myeloma.   "
160407|NCT01183936|"     Objectives: The purpose of this study was to assess the effects of an excision margin of 2 cm     versus 4 cm for patients with primary cutaneous malignant melanoma (CMM).      Study hypothesis: The hypothesis is that there is no difference between the two treatment     arms measured as overall survival and recurrence free survival.   "
160408|NCT01183923|"     Sulforaphane (SFN) is a naturally occurring isothiocyanate that is a potent inducer of Phase     II enzymes which play a critical role in preventing oxidative stress (via activation of     Nrf2). Broccoli sprouts (BS) contain the richest source of SFN.      The main objectives of this study are to test the effect of broccoli sprouts (BS) on     biomarkers of oxidative stress (OS), inflammation, basophil activation, and clinical outcomes     in mouse allergen-induced asthma by (1) determining if BS improves lung function and airways     symptom responses in mouse-sensitized adults with asthma undergoing environmental mouse     allergen challenge (EMAC), (2) examining the effect of BS on OS, inflammation, and basophil     activation, and (3) examining the effect of BS on changes in OS, inflammation, and basophil     activation after EMAC.   "
160409|NCT01183910|"     A randomized, double-blind, placebo controlled study to assess the safety and effectiveness     of a novel oral natural extract to improve the appearance of the skin of patients with senile     purpura.   "
160410|NCT01183897|"     The purpose of this study is to see find out what effects, good and/or bad, the combination     of 3F8 and GM-CSF has on the patient and the cancer.   "
160411|NCT01183884|"     The purpose of this study is to find out what effects, good and/or bad, the combination of     3F8 and GM-CSF has on the patient and the cancer.   "
160412|NCT01183871|"     The investigators hypothesize that the lung resection would be associated with lower jugular     bulb oxygen saturation in patients with severe pulmonary dysfunction than in patients with     healthy lung functions.   "
160413|NCT01183858|"     This prospective, double-blind, randomized study will evaluate the safety and efficacy of two     dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control     rates and overall survival in patients with advanced or metastatic non-small cell lung cancer     (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current     smokers and not intending to stop smoking during the study. Patients will be randomized to     receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will     continue until disease progression.   "
160442|NCT01183481|"     The primary objective of this pilot study is to examine the efficacy of Aprepitant given in     combination with Granisetron for the prevention of delayed-phase RINV in 84 patients     receiving a single 8Gy of moderately emetogenic palliative RT in the RRRP at Sunnybrook     Odette Cancer Centre for painful bony metastases from any primary solid tumor. Patients will     be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least     one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings     on Days 1 and 2 following the radiation treatment.. Secondary objectives include determining     the complete RINV prophylaxis rate (acute and delayed phases), the partial emesis control     rate, the safety of the combined regime, QOL issues, the time to the first emetic event and     the time to the first use of rescue medication .   "
160414|NCT01183845|"     The Crohn's Disease Endoscopic Index of Severity is a validated index to assess the severity     of ileocolonic lesions. Depth of ulcerations are evaluated in each segment of ileocolon and     the surface of lesions and ulcerations are reported on a 10-cm analogic scale. The Crohn's     Disease Endoscopic Index of Severity is the main score used in controlled trials to assess     the endoscopic severity of lesions in Crohn's Disease.      The investigators aim to conduct a prospective pilot study primarily to evaluate the     applicability of the Crohn's Disease Endoscopic Index of Severity to data obtained by the     colonic capsule endoscopy procedure, provided that conventional ileo-colonoscopy and capsule     endoscopy lead to comparable overall severity evaluations.      Secondary objectives are to assess reproducibility of the reading of data obtained by CCE and     to compare these data with those obtained by conventional ileocolonoscopy. If overall     severity evaluations derived from the two examinations are not comparable, the secondary     objectives will be used in an attempt to understand the reasons of this discrepancy.   "
160415|NCT01183832|"     This study is a description of the radiation effects on the healthy tissues in patients     receiving Anastrozole, sequential or in association with radiotherapy.   "
160416|NCT01183819|"     The purpose of this study is to test the hypothesis that aerobic exercise and a     computer-based cognitive intervention leads to improved cognitive function accompanied by     increases in gray matter density and changes in functional magnetic resonance imaging (fMRI)     patterns of task-related activation.   "
160513|NCT01182532|"     The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine     (TCM) for treatment of hand, foot, and mouth disease (HFMD).   "
174239|NCT00121719|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of lenvatinib in     patients with solid tumors or lymphomas.   "
160417|NCT01183806|"     The purpose of this study is to determine whether a exercise program when combined with     rivastigmine (Exelon patch) drug treatment compared with rivastigmine drug treatment alone     would improve quality of life, ability to perform activities of daily living (ADL) and     cognition in patients with Alzheimer's disease.      Hypothesis:      Ho: Rivastigmine drug treatment combined with exercise is not superior to rivastigmine drug     treatment to improve quality of life of Alzheimer's disease patients.      H1: Rivastigmine drug treatment combined with exercise is superior to rivastigmine drug     treatment to improve quality of life of Alzheimer's disease patients, with an expectative of     15% of improvement in the quality of life scale measurement   "
160418|NCT01183793|"     It is essential to know intestinal length and anastomotic type in post-operative short bowel     syndrome patients. These parameters can help predict long-term intestinal failure with     long-term parenteral nutrition usually needed for smallest lengths. Sometimes these     parameters are unfortunately missing for lack of intraoperative measurement. Thus, it is     necessary to develop non-invasive and reproducible techniques to assess small bowel length.     This is the reason why the investigators will evaluate magnetic resonance (MR)-enterography     and barium follow-through in this indication. There are at this time only two small studies     evaluating barium follow-through for intestinal length measurement, and none evaluating     MR-enterography. However, a major advantage of the latter is the lack of radiation exposure     and possibility to perform 3D.      This will be an open labelled single center crossover study. Short bowel syndrome patients of     the investigators center will be included after consent. The sequence of exams (MR     enterography followed by barium follow-through or vice-versa) will be randomly assigned.     Peroperative short bowel length measurement will be available for all patients. There will be     one month between the two exams.      The main objective of this study is to assess the performance of MR-enterography in short     bowel measurement in short bowel syndrome patients, the gold standard being peroperative     length. Secondary objectives are to assess the performance of barium follow-through in short     bowel measurement in these patients, and to show that barium follow-through does not perform     better than MR-enterography. For that purpose the investigators will include 50 patients over     2 years.   "
160419|NCT01183780|"     The purpose of this study is to compare overall survival in participants with metastatic     colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.   "
160420|NCT01183767|"     The aim of this multicentre, prospective, double blind, placebo controlled, randomized pilot     study is to investigate safety and tolerance of Epigallocatechin-Gallate (EGCG, the major     polyphenol in green tea) in patients with muscular dystrophy of the Duchenne type.      In a second step the investigators want to investigate the effect of EGCG on the course of     the Duchenne condition.   "
160421|NCT01183754|"     1. To evaluate the role of VerifyNow test as prognostic marker in routine clinical practice          using drug-eluting stents.        2. To determine the add-on-effect of VerifyNow test beyond on conventional risk factors          (clinical, lesions, or procedural factors).        3. To compare the prognostic utility of VerifyNow test with several biomarkers.   "
160422|NCT01183741|"     The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational     device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood     pressure (BP) in adult subjects.   "
160423|NCT01183728|"     In this prospective study we aim to evaluate the feasibility and safety of the implantation     of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). The     working hypothesis proposes that MSV antiinflammatory effect will help healing of articular     cartilage degeneration to a grade enough to be objectivized by questionnaires and imaging     procedures. The study of quantitative changes in structure and composition of cartilage     determined by MRI T2-mapping (Cartigram ) will be performed at 6, 12 and 24 months. Pain and     disability will be assessed by visual analogue scale (VAS), WOMAC, Lequesne Index and     evaluation of the quality of life by Short Form 36 questionnaire (SF-36) completed at 3, 6,12     and 24 months.   "
160424|NCT01183715|"     The primary purpose of this study is to evaluate the safety, tolerability and     pharmacokinetics of single oral doses of PF-05161704 in healthy volunteers.   "
160425|NCT01183702|"     The research will utilize LASIK and non-LASIK populations to analyze the biomechanical     differences between these corneas.   "
160454|NCT01183325|"     For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or     the use of mesh continues.      About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh     with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of     using this patch, recent experience showed several drawbacks both in design and efficacy (3).      With the recent development of the Proceed Ventral Patch (PVP), new elements have been     introduced to overcome some of these issues.      The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the     intra-abdominal position in the treatment of small ventral hernias.   "
160426|NCT01183689|"     The Study of Novel Approaches for Prevention (SNAP) is randomized trial designed to test     whether behavioral interventions based on self-regulation can prevent weight gain in young     adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Two different self-regulation     interventions for weight gain prevention will be compared in this trial; one intervention     will focus on making small, consistent, changes in eating and exercise behavior to prevent     weight gain or reverse weight gain if it occurs, whereas the other will emphasize larger     changes in eating and exercise that occur periodically, with a goal of producing weight loss     and thereby providing a buffer against anticipated weight gains. The primary aim of the trial     is to test whether the magnitude of weight gain from baseline across an average three-year     follow-up differs across the three groups, with the hypotheses that weight gain will be     greater in the Control group than in either intervention and greater in the Small Changes     than Large Changes group.      SNAP-E (Extension) will determine whether the effects of the intervention can be maintained     over an additional 3 years (i.e. through a total of 6 years).   "
160427|NCT01183676|"     The objective of this study was to investigate the bioequivalence of Mylan's divalproex     sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following     a single, oral 500 mg (1 x 500 mg) dose administration under fed conditions.   "
160788|NCT00000225|"     The purpose of this study is to determine if four times a subject's daily maintenance dose     will hold for 96 hours without changes in agonist and antagonist effects.   "
160430|NCT01183637|"     The Kensey Nash Corp. Cartilage Repair Device is a bioresorbable scaffold designed to promote     repair of knee cartilage and subchondral bone. Subjects with knee cartilage damage meeting     eligibility criteria will be randomly assigned to receive treatment with the Cartilage Repair     Device or a standard surgical technique called microfracture. The purpose of the study is to     evaluate the initial safety and effectiveness of the Cartilage Repair Device compared to     microfracture.   "
160431|NCT01183624|"     An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain     of the right or left knee.   "
160432|NCT01183611|"     The primary safety objective of this study is to assess the safety of 10 mcg recombinant     hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is     to assess the antibody response following 3 doses immunization of the 10 mcg experimental     dose and 10 or 5 mcg control dose, Participants will include up to 1740 healthy neonates.     This is a randomized, double-blinded, Phase III study. This study is designed to investigate     the safety, reactogenicity, and immunogenicity of 10ug recombinant hepatitis B vaccine     (yeast). Subjects will be stratified by the mother with positive for both HBsAg and HBeAg,     positive for the surface antigen but negative for HBeAg, negative for the HBsAg and HBeAg and     HBeAb and HBcAb.        -  Stratified 1: There are 180 neonates born to the mother with positive for both HBsAg and          HBeAg will be randomized into two groups according to the ratio of 2:1. 120 subjects          will receive the 10 mcg experimental vaccine and 60 subjects will receive 10 mcg control          vaccine respectively.        -  Stratified 2: There are 360 neonates born to the mother with positive for HBsAg but          negative for HBeAg will be randomized into two groups according to the ratio of 2:1. 240          subjects will receive the 10 mcg experimental vaccine and 120 subjects will receive 10          mcg control vaccine respectively.        -  Stratified 3: There are 1200 neonates born to the mother with negative for the HBsAg and          HBeAg and HBeAb and HBcAb will be randomized into 3 groups. 600 of them will receive the          10mcg experimental vaccine. 300 subjects will receive 10mcg control vaccine. And the          other 300 subjects will receive 5mcg control vaccine.      The recombinant hepatitis B vaccine will be administered at m0, 1 and 6. Following each     immunization, safety will be measured by assessment of adverse events through 30 days     following each vaccination, serious adverse events and new-onset chronic medical conditions     through 6 months post the final vaccination (Day 180 after last vaccination). For the     immunogenicity testing will apply the chemiluminescence immunoassay on serum obtained on the     day 0, 210 and 360 after born.   "
160433|NCT01183598|"     This open-label, single center study will provide RoActemra/Actemra (tocilizumab) to a     maximum of 4 patients with Multicentric Castelman's Disease who have demonstrated benefit     from RoActemra/Actemra in study MRA004US (Chugai Pharma USA) without major toxicities or     significant adverse events. Patients will receive their most effective maintenance dose until     disease progression or significant toxicity occurs.   "
160434|NCT01183585|"     This single centre, open-label study will investigate the effect of RO4917838 on the     pharmacokinetics of Rosuvastatin, a frequently co-prescribed drug in healthy volunteers.     Healthy volunteers will receive multiple oral doses of RO4917838 and single oral dose of     Rosuvastatin.   "
160435|NCT01183572|"     The purpose of this study is to determine whether daily oral supplements of multivitamins     (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant     women results in lower prevalence of anemia in preparation for pregnancy when compared to     daily iron and folic acid supplements or folic acid alone.   "
160436|NCT01183559|"     The purpose of the study is to determine the most tolerable and safe dose of ZD6474 (Zactima)     when given with standard chemotherapy, radiation therapy and surgery in patients with cancer     of the esophagus   "
160437|NCT01183546|"     The purpose of this research study is to further develop and refine the Transfer Assessment     Instrument (TAI). The TAI is a clinical tool to be used by therapists to evaluate transfer     techniques and performance.   "
160438|NCT01183533|"     The purpose is to demonstrate the safety of intravenous tissue plasminogen activator (IV     t-PA) in ischemic stroke patients who present to the emergency department (ED) after     awakening with the symptoms of suspected ischemic stroke.   "
160439|NCT01183520|"     The overall goal of this project is to identify an appropriate level of high omega-3 fish     (salmon) consumption that will promote optimal omega 3 nutritional status without increasing     the level of lipid oxidation in the body.   "
160440|NCT01183507|"     The purpose of this research study is to evaluate the effect of two different exercise     programs on physical function in men and women 60 years of age and older.   "
160441|NCT01183494|"     This study is being done to determine the maximum dose of a certain chemotherapy drug     (irinotecan) that can be tolerated as part of a combination of drugs. There is a combination     of chemotherapy drugs typically used to treat cancer of the colon and rectum: 5-Flurouracil     (5-FU), leucovorin, and irinotecan; the combination is known as FOLFIRI. At the present time,     the Food and Drug Administration (FDA) has approved this drug combination for the treatment     of cancers of the colon and rectum. The FDA has also approved the use of a drug called     bevacizumab (or Avastin) in combination with FOLFIRI, and this is considered one of the     standards of care for all patients with colon and rectal cancer which has spread.      The best dose of irinotecan to use in the combination of FOLFIRI and bevacizumab is not     known. Earlier studies have shown that higher doses of irinotecan can be used safely as part     of the FOLFIRI combination, but it is unclear whether these same doses will be safe when     bevacizumab is added to this combination.   "
160443|NCT01183468|"     The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an     anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's     normal ability to fight infection and respond to injuries) that affects the cells thought to     be involved in the development of type 1 diabetes mellitus (T1DM, T1D).      All subjects enrolled in this study have new-onset T1DM (diagnosis of T1DM within 100 days of     Visit 0; T1DM diagnosis fulfilling American Diabetes Association standard T1DM criteria). The     focus of Part I of this trial (NCT01183468) is pharmacokinetics (PK), pharmacodynamics (PD)     and safety. Upon completion of Part I, including a satisfactory safety review, enrollment in     Part II (NCT01183455, Phase II Clinical Trial) will begin.   "
160444|NCT01183455|"     Aralast NP (alpha-1 antitrypsin, AAT), an alpha-1 proteinase inhibitor (human), was the drug     to be tested in this clinical trial. Aralast NP is an anti-inflammatory drug that affects the     cells that are thought to be involved in the development of type 1 diabetes mellitus (T1DM,     T1D). This study, known as RETAIN, was planned as a two-part trial to investigate the effect     of Aralast NP on preserving beta cell function and to determine if the intervention would     slow the progression of type 1 diabetes.      Part I of this trial (NCT 01183468) was an open-label, safety and dose level study consisting     of two groups. After completion of Part I, including a satisfactory safety review, enrollment     in Part II was to begin. Part II was designed as a two-arm, double-blind, placebo-controlled     clinical trial, and participants were to be randomly assigned to either the Aralast NP     treatment or placebo group.   "
160445|NCT01183442|"     The main aim of the investigation is to clarify, whether vitamin D supplementation in     coronary artery disease patients with vitamin D deficiency and postchallenge hyperglycemia     has an impact on endothelial dysfunction and parameters of insulin sensitivity and beta-cell     function.   "
160446|NCT01183429|"     The purpose of this study is to find out what effects, good and/or bad, the combination of     3F8 and GM-CSF has on the patient and the cancer.      Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of     one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has     been used safely in many patients, and it has killed cancer cells in some patients. One way     it can kill cancer cells is by causing the patient's own white blood cells to attack the     cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of     granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.   "
160447|NCT01183416|"     The purpose of this study is to see if high-dose 3F8 combined with GM-CSF is better than     standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what     effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the     antibody works against a very small amount of neuroblastoma (minimal residual disease) that     is left in the bone marrow.   "
160448|NCT01183403|"     The value of anti-TNF therapy in intestinal strictures related to Crohn's disease (CD) has     not been clearly demonstrated. The results reported by some teams suggest no beneficial     effect or even an increased risk of bowel obstruction in the case of stricture, while other     publications indicate a favourable action of anti-TNF in this setting. The efficacy of     anti-TNF in patients with intestinal stricture related to Crohn's disease could depend on the     lesions responsible for the stricture, as anti-TNF agents are probably effective in     inflammatory forms and useless or even potentially harmful in fibrotic forms. In practice,     the decision is currently empirical and a trial of anti-TNF therapy is often proposed.      In view of the high incidence of intestinal strictures in CD and the need for a treatment as     effective as anti-TNF in this setting, it is important to more clearly define the indications     of these treatments guided by the information provided by modern imaging.      The aim of this prospective study is to determine whether certain signs detected by MR     enterography and contrast-enhanced ultrasonography can help to predict failure of anti-TNF     therapy in patients with CD presenting a symptomatic stricture of the small bowel and     scheduled to receive this treatment.   "
160449|NCT01183390|"     The objective of this study is to evaluate the comparative bioavailability between     Anastrozole 1 mg Tablets (Teva Pharmaceuticals, USA) and Arimidex® 1 mg Tablets (AstraZeneca     Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fed conditions.   "
160450|NCT01183377|"     Women's evermore presence in professional and athletic sports has revealed sound evidence on     the existence of female athlete triad among the world's elite female athletes. This triad     consists of eating disorders, amenorrhea and osteoporosis. It has been stated that all female     athletes are potentially at risk, but it is not clear to what extent those exercising at     different levels are at risk of this syndrome/triad. Since the manifestation of this triad is     often denied, or under-reported, appropriate screening methods are required to identify the     symptoms. There is still no clear-cut information available on the incidence of this triad in     Iran. And there are religious and cultural differences between Iran's elite female athletes     and those in other countries. Therefore, in order to meet Iranian female athletes' needs, the     investigators decided to determine the frequency of the female athlete triad in Iran.   "
160451|NCT01183364|"     This is an open-label, Phase 1, dose-escalation study to determine the recommended doses of     STA-9090 (ganetespib) and docetaxel for the treatment of subjects with solid tumor     malignancies. The safety and tolerability of the treatment will also be evaluated.   "
160452|NCT01183351|"     The increasing prevalence of dementia is a major challenge to the health authorities in most     countries. Nearly all the persons suffering from dementia experience behavioural and     psychological symptoms (BPSD). The prevalence of BPSD is particularly high in nursing homes.     BPSD are often treated with psychotropic drugs even though the evidence for effect is minimal     and the risk of serious adverse events is considerable. All the major treatment     recommendations advise that non-pharmacological measures should be applied first when     treating BPSD even though the evidence for such treatment is limited. The investigators will     conduct a pilot study of a non-pharmacological treatment for BPSD. The method has been     developed in Norway and has already been implemented in a number of nursing homes in the     county of Nordland.   "
160453|NCT01183338|"     The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational     device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human     subjects.   "
160766|NCT00000203|"     The purpose of this study is to evaluate varying doses of buprenorphine for opioid dependence     and cocaine abuse.   "
160455|NCT01183312|"     The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness     and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is     caused by a problem with the quality of sleep occurring at night, for instance when nighttime     sleep is disrupted by frequent breathing pauses. In other cases, however, hypersomnia occurs     even when nighttime sleep is of good quality. These cases of hypersomnia are presumed to be a     symptom of brain dysfunction, and so are referred to as hypersomnias of central (i.e., brain)     origin, or primary hypersomnias.      The causes of most of these primary hypersomnias are not known. However, our group has     recently identified a problem with the major brain chemical responsible for sedation, known     as GABA. In a subset of our hypersomnia patients, there is a naturally-occurring substance     that causes the GABA receptor to be hyperactive. In essence, it is as though these patients     are chronically medicated with Valium (or Xanax or alcohol, all substances that act through     the GABA system), even though they do not take these medications.      Current treatment of central hypersomnias is limited. For the fraction of cases with     narcolepsy, there are FDA-approved, available treatments. However, for the remainder of     patients, there are no treatments approved by the FDA. They are usually treated with     medications approved for narcolepsy, but sleep experts agree that these medications are often     not effective for this group of patients.      Based on our understanding of the GABA abnormality in these patients, we evaluated whether     flumazenil (an medication approved by the FDA for the treatment of overdose of GABA     medications or the reversal of GABA-based anesthesia) would reverse the GABA abnormality in     our patients. In a test tube model of this disease, flumazenil does in fact return the     function of the GABA system to normal. The investigators have treated a few patients with     flumazenil and most have felt that their hypersomnia symptoms improved with this treatment.      To determine whether flumazenil is truly beneficial for primary hypersomnia, this study will     compare flumazenil to an inactive pill (the placebo). All subjects will receive both     flumazenil and the placebo at different times, and their reaction times and symptoms will be     compared on these two treatments to determine if one is superior. Currently, flumazenil can     only be given through an injection into a vein (i.e., intravenously). This study will     evaluate this intravenous dosing as well as a new form of flumazenil, which is taken as a     lozenge to be dissolved under the tongue. If this study shows that flumazenil is more     effective than placebo in the treatment of hypersomnia, it will identify a potential new     therapy for this difficult-to-treat disorder.   "
160477|NCT01183013|"     The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30     weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual     monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and     linagliptin (5 mg, administered orally once daily). In addition, durability of treatment     effect and safety under chronic treatment conditions will be investigated.   "
160456|NCT01183299|"     The Salty Life 7 study aimed to examine the effect of a high salt (sodium chloride, NaCl)     intake on different forms of sodium retention, acid-base balance and bone metabolism and     other influenced physiological systems. Because of the fact that astronauts are a vulnerable     group in this context, they were of special interest. Astronauts have a high salt intake,     probably because of a reduced sense of taste, as well as an increased bone resorption     resulting from the lowered mechanical load in space. In which forms sodium could be retained     even without fluid retention (osmotically inactive)- contrary to the argumentation of     physiological text books - and if the acid-base balance is connected to sodium chloride     induced bone loss is examined in a stationary bed rest study with 8 healthy, young, male test     subjects. The study consisting of 2 x 21 days is carried out at the German Aerospace Center     (DLR). After an adaptation period of 4 days, test subjects are immobilised in 6° head-down     tilt bed rest (simulation model for some physiological changes in space) for 14 days during     which they received a high (7.7 mmol NaCl/kgBW/d) and a low salt (0.7 mmol NaCl/kgBW/d)     intake in cross-over design. The form of sodium retention is investigated by the calculation     of daily metabolic sodium-, water- and potassium balances and by changes in body weight. The     measurements of bone formation (bAP, PINP, Osteocalcin) markers as well as bone resorption     markers (CTX, NTX) supply insight into the influences of a high salt intake on bone     metabolism. Blood gas analysis and ph values of 24-h urine are used to gather information     about accompanying changes in the acid-base balance. Further physiological systems like     energy metabolism and circulation system are also under investigation.   "
160457|NCT01183286|"     Adolescents with cystic fibrosis are particularly vulnerable to poor adherence, which     negatively impacts their health status, quality of life and long term survival. CFFONE: A     Cell Phone Support Program for Adolescents with Cystic Fibrosis, will make use of     cutting-edge technology- a broadband capable, cellular telephone keyed into a     highly-interactive informational web site. This web site will provide engaging online     learning activities and resources specific to adolescents with cystic fibrosis. We believe     the information and activities contained in CFFONE will improve adolescents knowledge,     attitudes, and practices around cystic fibrosis and that adolescents exposed to the CFFONE     program will demonstrate an increase in adherence to their treatment regimens and related     improvements in their health status and quality of life.   "
160458|NCT01183273|"     Background Laparoscopy is the preferred surgical approach for a number of different diseases     as it allows for diagnosis and treatment in the setting of a safe and feasible method     offering enhanced cosmesis. The natural evolution of laparoscopy is micro-laparoscopy which     utilizes smaller instruments and optics. Technological advancements have enabled     miniaturization of the surgical equipment without compromising diagnostic or operative     capabilities.      Dr. Keith Zuccala is currently performing micro-laparoscopic gastric bypass with an identical     safety profile as traditional laparoscopy (NSQIP data comparison between Dr. Laura Choi and     Dr. Keith Zuccala). The current trend in laparoscopy is to minimize incisions and their size     to decrease trauma to the abdominal wall.      Study Design Both methods have never been compared in a prospective randomized trial to     address the following questions.        1. Is there a difference in outcome?        2. Is there a decrease in postoperative pain?        3. Does it decrease time off from work?        4. Does micro-laparoscopy increase OR time?        5. What is the effect on cost of micro-laparoscopy? Patients will be randomized to one or          the other method, disclosing that to the investigators best knowledge both methods are          equally safe and that Dr. Zuccala has performed several hundred cases using both          methods.      Patient Population Projected sample size would be 50 patients in each group. Accrual should     be feasible over the course of 9-12 months.      Data collection (patients will be followed for a total of 30 days for the purpose of this     study)        1. NSQIP data to assess outcome        2. Postoperative usage of pain medication while in the hospital        3. Time off from work        4. OR time        5. Direct cost of procedure as it relates to material used   "
160472|NCT01183078|"     Hypothesis: Utilization of the wand method will enhance improvements in drill placement,     locking nail placement during tibia and femur fracture repairs, and offer less radiation     exposure and less operative time. The purpose of this research study is to compare the     efficacy of distal locking of intramedullary nails using a standard free-hand technique with     the guided wand technique. Distal locking is the placement of screws through the     intramedullary rod to hold it in place and prevent rotation. Currently, the free-hand     technique is most often utilized. With this technique, the surgeon uses intraoperative x-rays     in order to find the holes in the intramedullary rod to place the screws. The wand technique     uses electromagnetic fields rather than x-rays to find these screw holes. The utilization of     the wand technique could result in improvements in drill placement and locking nail placement     as well as decrease operative time and radiation exposure.   "
160767|NCT00000204|"     The purpose of this study is to evaluate buprenorphine in a medical maintenance model three     times a week.   "
160768|NCT00000205|"     The purpose of this study is to compare the efficacy of buprenorphine versus methadone.   "
160459|NCT01183260|"     In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology,     Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was     developed to address the limitations of other implant materials, with the potential to     improve implant fixation.      Porous tantalum (80% porosity) offers potentially greater ingrowth and bone graft     incorporation, believed to be restricted by the low porosity of other commonly used implants     (30%). Additionally, the low modulus of elasticity property (3 MPa) of porous tantalum     provides more normal physiological loading conditions which theoretically reduce stress     shielding and resultant bone loss surrounding the implant. These properties are much desired     advantages for implants used in cementless THA.      Various porous tantalum implants have shown favorable clinical results. Unger et al. reported     excellent bone graft incorporation of the acetabular component based on serial radiograph     data at a minimum 1-year follow-up.      Dual-energy X-ray absorptiometry (DEXA) is a well-established method for detecting     periprosthetic bone mass changes around the femoral and acetabular THA components.      The primary objective of this study is to quantify and compare periprosthetic bone mineral     density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed     acetabular components, measured using DEXA scanning techniques. Additionally, this study will     analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.   "
160460|NCT01183247|"     An open, single center, randomised study to investigate three different immunosuppressive     regimens for de novo renal transplant recipients:        1. st sirolimus / EC-MPS / tacrolimus regimen           - After 3 months a protocol biopsy is performed. If no rejection is detected the          calcineurin inhibitor (tacrolimus) is withdrawn.        2. nd everolimus / EC-MPS / tacrolimus regimen           - After 3 months a protocol biopsy is performed. If no rejection is detected the          calcineurin inhibitor (tacrolimus) is withdrawn.        3. rd tacrolimus / EC-MPS / prednisone regimen - After 3 months a protocol biopsy is          performed. If no rejection is detected prednisone is withdrawn.   "
160461|NCT01183234|"     The purpose of this study is to assess bioequivalence of 2 capsule strengths.   "
160462|NCT01183221|"     This study examines the effects of oxytocin on complex social cognition in adults with autism     spectrum disorders. Participants receive a one-time administration of intranasal oxytocin (or     placebo) and perform an empathic accuracy task, a novel and ecologically valid measure of     complex social cognition, in conjunction with functional magnetic resonance imaging (fMRI).     We will investigate the effects of oxytocin (versus placebo) on the behavioral and neural     correlates of empathic accuracy.   "
160463|NCT01183208|"     A Phase I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group,     Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to     Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and O-Toluidine;     and the Safety and Tolerability of PSD502 in Female Healthy Volunteer Subjects Following     Daily Application to the Vagina and Cervix for Seven Days With Three Different Doses of     PSD502 or Placebo   "
160464|NCT01183182|"     This study is designed to provide clinical data regarding safety and clinical effectiveness     of the ActiSight Needle Guidance System in assisting radiologically guided percutaneous     needle biopsy or aspiration of pulmonary lesions, which is a common procedure.   "
160465|NCT01183169|"     The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who     have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may     benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus     placebo with PEG and RBV.   "
160466|NCT01183156|"     The aim of this study is to compare the effect of reminding letter and educational     intervention on attendance to screening colonoscopy in nonresponders to initial invitation to     screening colonoscopy.   "
160467|NCT01183143|"     This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the     convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating     hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also     in in-vitro fertilisation (IVF).   "
160468|NCT01183130|"     The aim of the study is to examine whether electronic compliance monitoring in real time     could offer some advantages compared to normal electronic monitoring in opioid substitution     treatment. The investigators would also like know whether this method could enable the quick     detection of possible problems in medication intakes and/or prevent the abuse or diversion of     substitution medications.   "
160469|NCT01183117|"     The main objective is to evaluate the safety and efficacy of SM-01 stenting (Cordis     S.M.A.R.T.™ Nitinol Stent System) for the treatment of SFA lesions as compared to PTA     (balloon angioplasty). If SM-01 is used in a PTA-bailout patient, the case will be assessed     separately.   "
160470|NCT01183104|"     The purpose of this study is to compare the efficacy and the safety of sitagliptin and     glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change     from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as     safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy     as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride     in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In     addition, comparison of efficacy is extended to 104 W.   "
160471|NCT01183091|"     The atrial fibrillation is the most frequent confusions of the heart rhythm: his preValencia     increases with the age, and the investigators consider that beyond 65 years, 5 % of the     population is affected by this arrhythmia. It entails a greater risk of morbidity     (thromboembolic accident and cardiac insufficiency) and of cardiovascular mortality     (mortality increased by a factor 1,7 - 2) independents of the causal pathology or the     associated risk factors. For all these reasons, it raises a real problem of public health.   "
160494|NCT01182779|"     This study is a prospective randomised clinical phase III trial. The primary objective of     this study is to evaluate, if the innovative therapy (carbon ion irradiation) in chordomas is     superior to the standard proton treatment with respect to the local-progression free survival     (LPFS).   "
160495|NCT01182766|"     This research study aims to test whether topiramate (a drug that is being used for seizure)     will help individuals who have problems with both alcohol and nicotine. The investigators     believe that individuals taking topiramate will be more successful at abstaining from both     alcohol and nicotine than individuals taking placebo.   "
160473|NCT01183065|"     The purpose of this study is to find out if the experimental drug pralatrexate with the     vitamins folic acid and vitamin B12 might be an effective treatment for head and neck cancer.     The reason we are doing this study is because another drug called methotrexate has been used     for a long time to treat head and neck cancer patients. Pralatrexate was designed by     scientists to be a new drug that works better than methotrexate. Laboratory studies have     shown that pralatrexate works better than methotrexate at killing cancer cells.      Pralatrexate has already been studied in patients with other types of cancers, such as     lymphoma and lung cancer. The results from those studies were promising. Pralatrexate was     recently approved by the Food and Drug Administration (FDA) as a new treatment for a cancer     called peripheral T cell lymphoma.   "
160474|NCT01183052|"     The purpose of this study is to understand the underlying mechanisms of improved exercise     tolerance in COPD patients after training program.   "
160475|NCT01183039|"     The purpose of this study is to understand underlying mechanisms of improved exercise     tolerance in Healthy Sedentary Subjects after training program.   "
160476|NCT01183026|"     The objective of the study was to assess diagnostic performance of V/Q SPECT for the     diagnosis of pulmonary embolism by comparing V/Q SPECT results to a validated diagnostic     strategy.   "
160478|NCT01183000|"     Objective: To determine the effect of non-closure of the visceral and parietal peritoneum     during Cesarean section on the formation of adhesions.      Study design: A prospective randomized trial of 533 women undergoing primary Cesarean     section; 256 were randomized to non closure and 277 to closure of the peritoneum. At a     subsequent cesarean,he presence of adhesions and their severity was evaluated at several     sites: between the layers of the abdominal wall, between the bladder and the abdominal wall,     between bladder and uterus, between the uterus and the abdominal wall, and between the bowels     and the pelvic organs. A cumulative adhesion score was calculated.   "
160479|NCT01182987|"     The SCAN Memory Program Evaluation study is an evaluation of a randomized controlled trial     intervention consisting of a care management program for cognitively-impaired health plan     members and for their informal/family caregivers. The program includes collaboration between     the health plan, partnering medical groups, and community organizations.      Program activities include: 1) telephonic-structured assessments with informal caregivers     conducted by SCAN Memory Program care managers; 2) problem identification as a result of     these assessments; and 3) pre-established protocols and procedures for problem resolution.     ACCESS, the prototype for the SCAN Memory Program, was developed and tested in San Diego     County and was very successful in helping affected patients and their caregivers.   "
160480|NCT01182974|"     The investigators will examine the toxicity of therapeutic doses of paracetamol in patients     in severe sepsis. Patients with fever and severe sepsis will be randomized to receive     paracetamol or dypirone. The investigators will monitor blood glutathione and liver enzymes     to look for potential toxicity.   "
160481|NCT01182961|"     The study aims to investigate the efficacy of gait training using virtual reality to decrease     the risk of falls in elderly idiopathic fallers. The investigator hypothesize that training     with virtual reality would increase the ability to perform in the real world environment     and decrease the risk of falls in elderly adults.   "
160482|NCT01182948|"     The purposes of this study are: a) to compare the effects of supervised programs of aerobic     training or resistance training on the metabolic control of type 2 diabetes; b) to     investigate some potential pathophysiologic and molecular mechanisms underlying these     effects; c) to assess whether some changes may persist over time after termination of the     supervised programs.   "
160483|NCT01182935|"     Subjects with elevated serum triglycerides in the 4th Tromso study in 1994/1995 were     re-examined with an oral glucose tolerance test to see predictive value of triglycerides     regarding development of type 2 diabetes   "
160484|NCT01182922|"     The purpose of the study is to investigate whether the information about a doctor or     possibility to choose doctor's gender included in invitation letter is associated with     attendance rate to screening colonoscopy.   "
160485|NCT01182909|"     Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in southern China     and Southeast Asia. While infection with Epstein-Barr Virus (EBV) is believed to be necessary     for the development of NPC, non-viral environmental factors have also been implicated to     increase the risk of NPC including consumption of salted fish and other nitrosamine     containing preserved foods, formaldehyde and wood dust exposure, and cigarette smoking. In     addition to environmental factors, it is widely accepted that genetic susceptibility also     plays an important role in the pathogenesis of NPC. Polymorphisms in genes involved in     nitrosamine metabolism and DNA repair have been suggested to be associated with NPC risk, and     various chromosomal regions linked to NPC development have been reported. These associations     highlight the role of both environmental and genomic components in the etiology of NPC.      There is a longstanding history of international collaborative studies to elucidate the role     of environmental and genetic factors associated with NPC between investigators in Taiwan and     the USA. A case-control study (375 cases; 327 controls) was conducted in the early 1990s, and     a large multiplex family study that was completed in 2006 (358 families; 3,216 individuals).     Results from these studies have provided some of the most comprehensive epidemiological     evidence regarding factors linked to NPC development to date.      As a next logical step, the opportunity now exists to undertake a genome-wide association     study of NPC in Taiwan with carefully collected environmental exposure data to systematically     examine environmental and genetic factors associated with NPC, and to evaluate gene-gene and     gene-environment interactions. The investigators propose a case-control study of 2000 NPC     cases (both retrospective [n=800] and prospective [n=1,200]) and 2,000 age-gender-matched     hospital controls in northern Taiwan. The study objectives are to: 1) evaluate putative     environmental exposures and NPC; 2) assess the effect of genetic factors, including both     single nucleotide polymorphism and copy number variation through analysis of both main effect     and gene-gene interaction; 3) investigate gene-environment interactions by testing for     interactions between significant genome-wide genetic variations and EBV and other identified     environmental risk factors; and 4) examine the natural history of EBV infection.   "
160496|NCT01182753|"     The study is a prospective randomised clinical phase III trial. Proton therapy is the gold     standard in the treatment of low and intermediate grad chondrosarcomas of the skull base.     However, high-LET beams such as carbon ions theoretically offer biologic advantages by     enhanced biologic effectiveness in slow-growing tumors. Up until now it was impossible to     compare two different particle therapies, i.e. proton and carbon ion therapy directly with     each other. The aim of this study is to find out, whether the biological advantages of carbon     ion therapy mentioned above can also be clinically confirmed.   "
160486|NCT01182883|"     Background:      - IMC-A12 is an experimental substance designed to inhibit a protein called Type I     Insulin-Like Growth Factor Receptor (IGF-1R), which can be found on cancer cells and can     promote cancer growth. Temsirolimus is a drug that the U.S. Food and Drug Administration has     approved to treat advanced renal cell carcinoma in adults. Researchers do not know if the     combination of IMC-A12 and temsirolimus will work in children, but want to determine whether     these two drugs may be an effective treatment for recurrent tumors.      Objectives:        -  To determine the safety and effectiveness of IMC-A12 and temsirolimus in treating          children and adolescents with solid tumors.        -  To determine possible side effects of the combination of IMC-A12 and temsirolimus.      Eligibility:      - Children and adolescents between 12 months and 21 years of age who have solid tumors that     have not responded to or have relapsed after standard treatment.      Design:        -  Participants will be screened with a medical history, physical examination, and imaging          studies.        -  Participants will receive IMC-A12 and temsirolimus in 28-day cycles of treatment.          IMC-A12 will be given as an infusion over 1 hour, once a week, for 4 weeks. Temsirolimus          will also be given after IMC-A12 over 30 minutes, once a week, for 4 weeks.        -  Participants may continue to receive IMC-A12 and temsirolimus for up to 2 years unless          serious side effects develop or the treatment stops being effective.        -  Participants will have additional physical exams, blood and urine tests, and imaging          studies regularly during each treatment cycle.        -  Participants will be followed at regular intervals after the end of the study to collect          tumor response and progression data....   "
160487|NCT01182870|"     Subjects included in ongoing vitamin d intervention trials were asked by questionnaire if     they were ill with influenza during the winter season 2009/2010 to see if vitamin d     supplementation prevented flu like disease.   "
160488|NCT01182857|"     Background:        -  Severe combined immunodeficiency (SCID) is a rare inherited disorder in which certain          white blood cells have impaired function and are unable to properly fight infections.          SCID typically appears within the first year of life and is characterized by multiple,          recurrent severe infections. More than 10 percent of all cases of SCID involve a          deficiency of an enzyme called adenosine deaminase (ADA), and these SCID patients also          tend to have impaired brain function or psychiatric disorders. Researchers are          attempting to treat ADA-SCID patients with an experimental gene therapy, and a research          protocol has been established for those who are participating in this therapy.        -  Little is known about quality of life in individuals with ADA-SCID, but researchers          believe that the effects of the disease and the treatments may cause a decreased quality          of life in both patients and their parents. Another potential cause of decreased quality          of life in ADA-SCID is the associated psychiatric and neurological problems caused by          the disease. Researchers are interested in studying quality of life in individuals with          ADA-SCID and their parents to provide more information about the disease.      Objectives:        -  To evaluate whether gene therapy alters the quality of life or neuropsychiatric status          of children with ADA-SCID.        -  To monitor for intellectual, attention, memory, or specific learning disorders in          children with ADA-SCID.        -  To evaluate whether undergoing gene therapy has an effect on parenting stress of parents          whose children have ADA-SCID.      Eligibility:        -  Children who are participating in the ADA-SCID gene therapy research protocol          (01-HG-0189).        -  Parents of children who are participating in the ADA-SCID gene therapy research protocol          (01-HG-0189).      Design:        -  All of the testing and questionnaires will be done in the pediatric or adult clinic.        -  Participating children will have tests of intelligence, manual dexterity, reaction time,          basic reading and arithmetic skills, speech, and memory. These tests will be given          before the start of the therapy, and then once a year for 5 years.        -  Participating children will also complete questionnaires on quality of life. These          questionnaires will be given before the start of the therapy, 3 months and 6 months          after the therapy, and then every 6 months for a total of 5 years.        -  Additional psychological tests may be given at the discretion of the study researchers.        -  Parents will complete questionnaires to provide background medical information and          report on quality of life and parental stress. The background information questionnaires          will be given at the start of the therapy and then once a year for 5 years, the parental          stress questionnaires will be given at the start of the therapy and then every 6 months          for 5 years, and the quality of life questionnaires will be given at the same time as          the child quality of life questionnaires.        -  This protocol is separate from the gene therapy treatment protocol.   "
160489|NCT01182844|"     Obesity and metabolic syndrome are linked by inflammation. Gut flora seems to play an     important role in the development of inflammation and metabolic syndrome in obesity.     Modulation of gut flora by probiotics has been shown in animal studies to positively     influence inflammation and metabolic disturbances.      Lactobacillus casei Shirota is able to decrease metabolic endotoxemia by altering gut flora     composition and gut permeability which leads to an improvement in neutrophil function and     insulin resistance in obesity.      The aim of the current study is to investigate the effect of Lactobacillus casei Shirota     supplementation over 12 weeks on neutrophil function (phagocytosis, oxidative burst and TLR     expression) in patients with metabolic syndrome.      Furthermore the investigators aim to investigate the effect of Lactobacillus casei Shirota     supplementation over 12 weeks on glucose tolerance, insulin resistance, inflammation, gut     flora composition, gut permeability, and endotoxemia in metabolic syndrome   "
160490|NCT01182831|"     Coeliac plexus neurolysis (CPN) is a management option for pain control in carcinoma     pancreas.CPN is conventionally performed by percutaneous technique with fluoroscopic     guidance. Endoscopic ultrasound (EUS) is increasingly used for CPN as it offers a better     visualization of the plexus. There are limited data comparing the two modalities.The patients     are on follow-up for 6 months post neurolysis.   "
160491|NCT01182818|"     More than one million people in Europe suffer from a stroke every day. Normally older people     have a stroke, but also a significant number of younger people between 18 and 55 years.     Usually, these can only be explained for a minority by the classical risk factors such as     diabetes, overweight and high blood pressure. New studies indicate that in about 1 - 2 % of     the younger stroke patients the etiology can be an undiagnosed genetic disease, e.g. Fabry     disease. Fabry disease is a lysosomal storage disorder known to cause vasculopathy. The     purpose of this study is to determine in a large number of young stroke patients, how many     strokes were caused by Fabry disease and what risk factors might be able to predict this     disease.   "
160492|NCT01182805|"     The purpose of this study is to evaluate a novel ultrasound system's ability to assess the     relaxing properties of the heart compared to current techniques.   "
160493|NCT01182792|"     Diseases associated with chronic hypoxemia like chronic obstructive pulmonary disease (COPD)     or emphysema, represent major medical and socio-economical problems and one of the leading     cause of morbidity and mortality in the western countries. Recently, is has been shown that     cardiovascular (CV) diseases contribute highly to the morbidity and mortality of these     patients. Furthermore, increasing evidence suggest that systemic vascular dysfunction play a     central role in the mediation of the increased CV risk in patients with COPD. However the     underlying mechanisms of vascular dysfunction in these patients are incompletely understood.     Chronic mountain sickness (CMS) is characterized by chronic hypoxemia related at least in     part to hypoventilation; it affects relatively young adults, and may therefore allow to study     the effects of chronic hypoxemia. The investigators therefore will assess systemic vascular     function and test the hypothesis that increased oxidative stress is responsible for this     dysfunction. Since polyglobulia is a hallmark of chronic hypoxemia and has been suggested to     affect vascular function, the investigators will test the effects of hemodilution on vascular     function. Then, the investigators will test the effects of acute oxygen application and 1     month antioxidative dietary supplement on vascular function.      Preliminary data suggest that offspring of CMS patients may display pulmonary and systemic     vascular dysfunction. Antioxidant administration is know to improve vascular function. We     will test the acute effect of Vitamin C in this setting.      Finally, since there is considerable inter-individual variability of pulmonary artery     pressure among CMS patients and the presence of a patent foramen ovale (PFO)is increased in     clinical conditions associated with pulmonary hypertension and hypoxemia, we will assess the     prevalence of PFO in healthy high altitude dwellers and in CMS patients and its effects on     pulmonary artery pressure at rest and during mild exercise.   "
160498|NCT01182727|"     Being obese is a common problem for people with schizophrenia. People with schizophrenia are     more likely to be overweight compared to the general population. Being overweight is a major     risk factor for developing type II diabetes. Approximately 15% of people with schizophrenia     have type II diabetes. People with type II diabetes have problems with their body's insulin.     Insulin is a hormone produced by the body to control blood sugar level. Obesity and type II     diabetes are strong risk factors for heart disease. In type II diabetes the body does not     respond to insulin correctly. Obesity, type II diabetes, and insulin resistance are all     common states of inflammation. Inflammation is a reaction by the body to irritation, injury,     or infection.      Salicylates are non-steroidal anti-inflammatory drugs. Aspirin is an example of a salicylate.     These drugs work by decreasing the level of inflammation in the body. Salicylates have been     shown to decrease inflammation and improve the body's response to insulin. Improving the     body's response to insulin and decreasing inflammation could possibly reduce the risk of     developing type II diabetes. Salicylates have been known for years to be effective for the     treatment of diabetes. Salicylates increase the body's response to insulin causing blood     sugar levels to decrease. Many salicylate drugs have side effects including stomach     irritation and increased risk of bleeding. The drug for this study is called salsalate and is     different from other salicylates. Salsalate has a lower bleeding risk than aspirin. Salsalate     has been used to treat arthritis and has been shown to be safe.      There have been no studies using salsalate in people with schizophrenia. The purpose of this     study is to gain experience in the use of salsalate in people with schizophrenia. The study     would be a pilot study to obtain preliminary data. The study would be a 6-week study where     everyone in the study would receive the drug salsalate. The participants in the study will     have tests of baseline symptoms of schizophrenia, a physical exam, EKG (to check heart     function), and a side effect checklist for possible side effects from salsalate. The study     will also have some blood drawn to measure blood sugar levels, insulin levels, and     inflammatory markers.   "
160511|NCT01182558|"     The purpose of this investigator-initiated study is to determine the effect of prior muscle     activation on the response obtained by nerve conduction studies (the compound muscle action     potential [CMAP]) looking at the amplitude, area, and duration of the CMAP and evaluating the     length of time the CMAP is larger than at baseline. On the opposite side, the corresponding     CMAP will be tested periodically, but there will be no muscle activation on that side.      Null Hypothesis: While controlling all possible technical and other known physiological     variables, prior activation of a muscle has no effect on the amplitude and area of the     compound muscle action potential (CMAP); and the CMAP does not change over time in the     relaxed muscle (on the opposite side).      The investigators suspect that there is an effect of prior activation of the muscle on the     subsequent CMAP recorded from that muscle.   "
160499|NCT01182714|"     Total abdominal hysterectomy is a common gynaecological operation performed worldwide. In     Hong Kong, it was the most common gynaecological open procedure done and the number of     hysterectomies performed increased by almost 50% in 2004 when compared to 1999. In-dwelling     catheter use after uncomplicated abdominal hysterectomy has been the standard method for     bladder treatment after the operation. It is traditionally advocated to assess urinary output     and to prevent post-operative urinary retention as patients with abdominal wound are unable     to increase the intra-abdominal pressure to aid voiding. However, in-dwelling catheters have     been associated with increased white cell counts and higher rates of positive urine cultures,     and subsequently urinary tract infection can lead to increased morbidity, duration of     hospital stay, and overall healthcare cost.      Duration of catheter use post-operatively is generally based on custom rather than     evidence-based knowledge and therefore varies considerably. The current practice of the     investigators hospital is to leave an in-dwelling catheter in-situ for 24 hours after an     uncomplicated open gynaecological surgery. Schiotz et al showed that twenty-four-hour     catheterization after common gynaecological procedures was associated with a low rate of     voiding problems after catheter removal. Post-operative urinary retention leading to bladder     atony may increase the long-term morbidity through increased risk of infection, detrusor     instability and voiding difficulties. In-dwelling catheter in the immediate post-operative     period will help to combat this problem. However, this has to be balanced against the     potential risk of catheter-associated urinary tract infection which varies from 5% to 43% in     the published trials.      A prospective randomized study comparing immediate versus delayed catheter removal following     hysterectomy showed that delayed removal after operation was not associated with an increased     rate of febrile events or urinary tract infections, but a significantly higher subjective     pain assessment. The size of the catheter used was 16F which was not the standard 12F that     the investigators used in the investigators hospital setting. It is postulated that if a     smaller caliber in-dwelling catheter is used, it will not result in an increased subjective     pain assessment, and the catheter can be left in-situ for 24 hours without causing increased     adverse outcomes but possibly reducing recatheterisation rate post-operatively.   "
160500|NCT01182701|"     The proposed study is a two arm randomized controlled trial with longitudinal follow-up that     compares cognitive behavioral interventions (ENHANCE) to a control group with attention. The     experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs.     Control) by Time (Pre, Post, Follow Up).   "
160501|NCT01182688|"     This study is designed to demonstrate the value of Procalcitonin (PCT) in assisting the rapid     diagnosis of post- operative infection that includes elevation of Procalcitonin above and     beyond the changes seen with the acute and inflammatory response induced by cardio-pulmonary     bypass.      Procalcitonin is an innovative and highly specific biomarker for clinically relevant severe     bacterial infections and sepsis. PCT supports early diagnosis and clinical decision     making.This is a prospective single center study designed to assess the normal change in PCT     levels following major surgery and the utilization of PCT regarding the diagnosis of     infection and the response to treatment, following major cardiac surgery   "
160502|NCT01182675|"     The goal of this study is to develop a novel approach to hematopoietic stem cell     transplantation for children with Severe Combined Immunodeficiency Disease (SCID) that     eliminates the use of toxic chemotherapy conditioning and maximizes the likelihood of T and B     cell immune reconstitution. Rather than classic chemotherapeutic agents, the investigators     will utilize a targeted stem cell mobilizer, plerixafor, in combination with alemtuzumab, a     monoclonal antibody. Correlative scientific questions will include: 1) efficacy and     characteristics of host stem cell mobilization; and 2) alemtuzumab pharmacokinetics in very     young children.   "
160503|NCT01182662|"     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells     (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg in subject for     the therapy of severe aplastic anemia (SAA).   "
160504|NCT01182649|"     Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in     all comers PCI eligible patients   "
160505|NCT01182636|"     The objective of this study was to evaluate the efficacy and safety of the test formulation     of adapalene gel 0.1% (PLIVA Research & Development Ltd.) as compared to the already marketed     formulation, Differin® (adapalene 0.1%) topical gel (Galderma Laboratories) in patients with     acne vulgaris.   "
160506|NCT01182623|"     It is current practice to remove any polyps found during colonoscopy. This is because     adenomatous polyps have the potential to turn into cancer. However, a proportion of polyps     <10mm in size are hyperplastic, which cannot turn into cancer. Current practice requires     these to be removed, as it is traditionally felt that they cannot be separated clinically     from adenomas. This increases the risk of perforation and results in a significant cost in     processing the samples. However, it has been suggested that it is possible to differentiate     neoplastic from non neoplastic lesions using skills in polyp surface pattern recognition. If     this is the case the investigators may be able to reduce the need for polypectomy The     investigators believe that it is possible to tell the difference between polyps with     cancerous potential and those that are harmless by assessment of surface patterns. This may     enable us to improve the investigators clinical decisions when assessing polyps during     colonoscopy, and reduce the number of unnecessary polypectomys being performed.   "
160507|NCT01182610|"     This is an open-label, Phase II, single-stage study evaluating the use of panitumumab,     paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal     adenocarcinoma. The expectation is that this combination will both increase potential overall     survival by incorporating novel biologic therapy in the neoadjuvant setting and decrease     potential surgical mortality by eliminating pre-operative radiation therapy.   "
160521|NCT01182428|"     The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus     Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on     clinical outcomes in the treatment of female patients with de novo coronary artery lesions,     and the characterization of the female population undergoing stent implantation with a XIENCE     stent.   "
160508|NCT01182597|"     Endoscopic hemostasis has been documented by a number of clinical studies to be effective in     decreasing rebleeding, need for emergency surgery, and hospitalization days. Studies showed     adjuvant treatment with proton pump inhibitor (PPI) after initial endoscopic hemostasis     reduced recurrent ulcer bleeding. However, the optimal dose and route of adjuvant PPI therapy     remains controversial. A recent study demonstrated frequent oral PPI offered similar acid     control as currently recommended intravenous infusion PPI did in patients with bleeding     ulcers. The investigators hypothesize that an frequent oral PPI treatment has similar benefit     as proton pump inhibitor infusion in patient with bleeding ulcers after combined endoscopic     hemostasis.   "
160509|NCT01182584|"     Graves' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy.     Pathogenesis involves autoimmune process. The investigators think temperatures of the area     involved in the inflammation may change. Thus the investigators plan to take temperature     pictures of Graves' patients using digital infrared thermal imaging system and observe the     change.   "
160510|NCT01182571|"     The purpose of this study is to explore the fatigue, uncertainty, depression and quality of     life in heart transplant recipients, and associated factors of quality of life .   "
160514|NCT01182519|"     The purpose of this study is to find out if there is a link between cigarette smoking,     inflammation and the spread of breast cancer to the lung. We think that women who are current     or former smokers may be at increased risk for breast cancer spreading to the lung compared     to women who have never smoked. Smoking causes inflammation in the lung in some women.     Researchers at Memorial Sloan-Kettering (MSKCC) think that smoking-related lung inflammation     may increase the chance of breast cancer spreading to the lung. In order to find out whether     inflammation plays a role in breast cancer spreading to the lung, we will measure a urinary     marker of lung inflammation. This will allow us to determine if this marker is more commonly     elevated in women with breast cancer that has spread to the lung compared to those without     breast cancer in the lung. We will also collect DNA from blood to have the opportunity to     determine if there are differences in DNA in women with or without breast cancer that has     spread to the other sites including the lung. We will also collect blood to determine if we     can identify risk factors for the spread of breast cancer to the lungs.   "
160515|NCT01182506|"     The purpose of this study is to test a memory training program for breast cancer survivors     who have problems with memory after receiving chemotherapy. Since breast cancer survivors     have been reported to have trouble with their memory, a program to help these problems is     important. Studies have shown that a 5-week software training program improved memory in     pediatric cancer survivors and other disorders like stroke, but it has not been tested for     breast cancer survivors. This study will see if breast cancer survivors can improve their     memory and attention problems by using either one of two software versions of the program.     One version is called Cogmed Working Memory Training, and the other is a comparison version     of the software that has the same exercises but is less difficult. People who decide to     participate in the study will be randomly given one of the two versions.   "
160516|NCT01182493|"     The purpose of this study is to evaluate the comparative effectiveness of insulin pump     therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are     sub optimally controlled with multiple daily injections (MDI).   "
160517|NCT01182480|"     This proof of concept study proposes to evaluate the feasibility of a     communications-technology-based chronic care and patient relationship management program to     improve diabetes self management among adult diabetic patients in an urban safety net     population by providing between-visit reminders and chronic disease support through cell     phone text messaging.      The investigators hypothesize that diabetic patients enrolled in the program will be less     likely to miss scheduled appointments and will have greater perceived self-efficacy and     improved patient satisfaction concerning chronic disease management. No-show rates among     patients enrolled in the program are expected to be lower than among patients receiving     standard care.   "
160518|NCT01182467|"     Crohn's disease (CD) is an autoimmune disorder which affects over 700,000 people in the U.S.     The disease can vary in severity and multiple drug classes are available to the disease     depending on disease severity and complications. Our purpose will be to study how PET-CT     scans can be used to better manage Crohn's Disease.   "
160519|NCT01182454|"     Blood pressure meter model CH-658 was to be assessed against the standard mercury     sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.   "
160520|NCT01182441|"     This is a prospective, randomized, multicenter study to provide additional information on the     safety and efficacy of the WATCHMAN LAA Closure Technology.      The PREVAIL study was amended to initiate a prospective, non-randomized continued access     study titled Continued Access to PREVAIL (CAP2) to collect additional information on the     safety and efficacy of the WATCHMAN LAA closure technology. The study is estimated to enroll     an initial cohort of 300 subjects with a maximum of 1500 subjects, at 60 investigational     sites in the U.S.   "
160803|NCT00000240|"     The purpose of this study is to test combined buprenorphine and behavioral treatment with and     without contingent reinforcement on opioid and cocaine abstinence.   "
160522|NCT01182415|"     Current standard treatments for lymphoma involving the central nervous system include     chemotherapy or whole brain radiation therapy (WBRT). However, many patients do not respond     to this treatment, and some of the patients who do respond relapse after treatment.      Previous research has shown that a stem cell transplant of a patient's own cells (autologous     stem cell transplant) may be more effective for some patients with lymphoma involving the     CNS. In previous research using autologous stem cell transplants for lymphoma involving the     CNS, a conditioning regimen consisting of the drugs thiotepa, busulfan and cyclophosphamide     (TCE) was used. These drugs have been shown to enter the nervous system.      In this research study, the investigators are adding the drug rituximab (Rituxan) to the drug     cytarabine for the stem cell mobilization process. Cytarabine is a standard drug for     mobilization. In addition, rituximab will be added to the conditioning regimen of thiotepa,     busulfan and cyclophosphamide. Rituximab is approved by the FDA for the treatment of some     types of lymphomas, but is not approved for use in lymphomas that involve the CNS. Rituximab     is known to be able to enter the CNS. Previous research has suggested that it may help treat     lymphoma that involves the CNS.      The goal of this research study is to see if adding rituximab to the stem cell mobilization     and conditioning regimens helps treat lymphoma that involves the central nervous system.   "
160523|NCT01182402|"     The purpose of this study is to improve unsupervised dosing of opioid substitution     medications. The aim of the study is to examine whether electronic compliance monitoring     provides some advantages to patients`treatment and what kind of patients especially benefit     from monitoring. We would also like to know if electronic compliance monitoring can prevent     the abuse/diversion of medications and how implementing this method to wider treatment     facilities succeeds.   "
160539|NCT01182194|"     This study was designed to compare the relative bioavailability (rate and extent of     absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets     (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablet) in healthy, adult     subjects administered under fasting conditions.   "
160540|NCT01182181|"     The objective of this study is to evaluate the comparative bioavailability between     Anastrozole 1 mg Tablets (Teva Pharmaceuticals USA) and Arimidex® 1 mg Tablets (AstraZeneca     Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fasting conditions.   "
160789|NCT00000226|"     The purpose of this study is to determine if four times a subjects daily maintenance dose     will hold for 96 hours without changes in agonist and antagonist effects under open dosing     conditions.   "
160524|NCT01182389|"     Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a heart attack     and can cause sudden death. Patients at risk of this rhythm disturbance usually receive an     implantable cardioverter defibrillator (ICD) that can prevent death by returning the heart's     rhythm back to normal by electrically stimulating the heart but in doing so gives the patient     painful and debilitating shocks. The first ICD shock after implantation appears to be a     powerful predictor of subsequent shock therapy as well as being a predictor of of increased     mortality in patients with primary prevention ICDs. In patients who receive repeated shocks     VT ablation is performed to 'burn' the abnormal area of the heart that causes the problem.     However, it is often only performed as a last resort as it is technically challenging. We     believe that performing VT ablation using the robotic system early after the first episode of     VT after ICD implantation, may reduce the number of painful shocks received by the patient     and possibly increase life expectancy and quality of life.      200 patients from 5 european countries will be recruited in a prospective, open, randomised     trial. Eligible, consenting patients who have experienced their first episode of VT since ICD     implantation, will be randomised in a 1:1 manner into treatment arms of either VT ablation or     standard 'conventional' therapy and followed-up every 4 months over two years to assess the     number of subsequent ICD shocks, hospitalisation, mortality and quality of life.   "
160525|NCT01182376|"     The primary objective of this study is to demonstrate how dronedarone (Multaq®) may aid in     the slowing of progression of left atrial and ventricular fibrosis in patients with atrial     fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging.   "
160526|NCT01182363|"     This application to the Boston University Medical Center Institutional Review Board outlines     a research plan devoted to identifying and managing maternal depression in Early Intervention     (EI). The target population is women who's children are enrolled in early intervention who     have experienced an adverse pregnancy outcome, defined as the birth of a child who was born     prematurely, low birth weight, or with birth defects. Early intervention provides     developmental services to the state's birth to three population under the Part C of the     Individuals with Disabilities Act (IDEA). Our intervention strategy involves the     identification of mothers whose children receive early intervention services and who,     themselves, are at risk for depression. Eligible mothers will be offered a preventative     intervention that involves the principles of Problem Solving Treatment (PST). Problem Solving     Treatment is a brief skills-building psychotherapeutic intervention that focuses on specific     daily problems, and applies to these problems a structured approach to finding and evaluating     solutions.      This study will be a parallel group randomized control trial (RCT) of 188 mother-child dyads.     Mothers in the intervention group will receive 6 sessions of Problem Solving Treatment, which     will be referred to as Problem Solving Education (PSE) in this application. The women in the     control site will receive usual care. Problem Solving Education interventionists (Problem     Solving Educators or PS Educators) will conduct Problem Solving Education with mothers of     children who receive early intervention services through Thom Child and Family Services, Bay     Cove Early Intervention program, South Shore Mental Health (Step One Early Intervention), and     Meeting Street Early Intervention with an enrollment goal of 188 mothers. In addition to     engaging in Problem Solving Education sessions, mothers who agree to participate in the study     will meet with research staff to complete 1)baseline assessment measures at study enrollment     and 2) outcome assessment measures 3 months after baseline assessment and 3) outcome     assessment measures 6 months after baseline assessment.   "
160527|NCT01182350|"     The primary objective of this study is to estimate the overall survival of children and young     adults with diffuse intrinsic pontine glioma treated (DIPG) with a molecularly based     treatment strategy, compared to historical controls.      Four Biopsies of tumor tissue will be obtained by surgical biopsy prior to treatment     stratification if tolerated. An MRI-guided frameless or frame-based stereotactic biopsy will     be performed approaching the pontine termentum through a trans-cerebellar or trans-frontal     route. The exact biopsy location will be determined by the treating neurosurgeon at the     designated participating site with the goal of minimizing procedural risk.      Following biopsy,all patients will receive local radiotherapy to consist of 59.4Gy delivered     using conventional conformal or other standard treatment planning with adjuvant bevacizumab.     Radiation planning can begin with the pre-operative images. Based upon molecular parameters     after biopsy, patients will potentially receive erlotinib and/or temozolomide at the start of     radiotherapy. Bevacizumab will be given concurrently with radiotherapy beginning at least     three weeks from the biopsy and at least two weeks after the start of radiation therapy to     ensure that primary wound healing has occurred. Once irradiation is complete, patients will     have a four week interim period before beginning the maintenance phase. Adjuvant chemotherapy     will be continued during the interim period.      The maintenance phase (approxmiately 40 weeks) will last for 10 cycles(28 days +/- 3 days).     Based upon molecular parameters as determined at the time of diagnostic biopsy, patients will     continue to receive erlotinib and/or temozolomide along with bevacizumab during the     maintenance phase.      Stratification will be based on O6-methylguanine-DNA methyltransferase (MGMT) promoter     methylation status and epidermal growth factor receptor (EGFR) expression in tumor biopsy     samples. If MGMT status and/or EFGR status are not determinable, patients may be treated as     per cohort #1(bevacizumab and irradiation) but will be analyzed separately.   "
160528|NCT01182337|"     Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5     in subjects with early lumbar disc degeneration   "
160550|NCT01182051|"     The primary aim of this proposal is to refine the intervention under investigation (i.e.,     family-based CBT) and evaluate the feasibility and acceptability of the intervention and     methods (e.g., recruitment, assessments).      The secondary aim of this proposal is to compare the relative efficacy of an 8 session     family-based cognitive-behavioral therapy (CBT) to Relaxation Training (RT) for reducing     anxiety and chronic headaches in youth (N = 30) ages 7-17 years. It is hypothesized that CBT     will result in greater reductions in both anxiety and headache frequency and severity     compared to RT.   "
160529|NCT01182324|"     The purpose of this study is to describe the experiences of parents, clinician researchers,     and industry professionals who were involved in phase II clinical trials of Ataluren for     Duchenne muscular dystrophy. We are especially interested in learning about motivations for     being involved in the clinical trial, expectations of the trial, the experience of the trial,     and relationships between the parents of children involved in the trial, the clinician     researchers, and PTC Therapeutics. In addition, we would like to learn more about whether and     how families and advocacy organizations experiences in following the progress of the drug,     encouraging the clinical trial, and supporting the phase II trials may have affected     participants thoughts and feelings about the study.   "
160536|NCT01182233|"     The purpose of this study is to improve the efficacy of the HDC regimen by adding a novel,     targeted means administering a variation of total body irradiation (TBI) radiation i.e.,     total skeletal irradiation (TSI) administered by helical tomotherapy (HT) before, and in     addition to the current standard of HDC, at a dose of 200 mg/m2 (HDMel200). The underlying     postulate of this endeavor is that TSI-HT will provide additional cytoreduction to HDMel     alone, without producing additional (serious) toxicity. We will utilize a classical Phase I     study design (i.e., dose escalation) in myeloma patients undergoing AHSCT2 to define a     maximum tolerated dose (MTD) and dose limiting toxicity (DLT). Finally, although comparisons     to other therapies are not typical (and/or feasible) for a Phase I study, we will compare,     whenever possible, both the toxicity and the antimyeloma activity of the AHSCT2 to AHSCT1.      This protocol will standardize, as much as possible the use of AHSCT2 both as a tandem and     salvage procedure. Since sufficient AHSC (CD34+ cells) are routinely collected in adequate     numbers for multiple AHSCTs, but recently used infrequently, it is important to work towards     defining the optimal utilization of this resource.   "
160530|NCT01182311|"     Background:        -  The hepatitis B vaccine has been shown to be safe and effective in preventing          transmission of the hepatitis B virus. Response rates to the initial three doses of the          vaccine are high, with significant or even complete immune response. However, this level          has been reported to decline rapidly within the first year and more slowly thereafter.          There is little data on the durability and long-term protection provided by the          hepatitis B vaccine administered to adults in the United States.        -  Vaccinated individuals are believed to be protected against hepatitis B virus infection          because of a memory immune response. Even if antibody levels are low, the immune system          will still be able to produce enough antibody to neutralize the hepatitis B virus.          Therefore, booster doses of the vaccine are not recommended, except for some high-risk          individuals such as patients on dialysis. Researchers are interested in determining the          durability of the immune response of the hepatitis B vaccine in adults with low or          intermediate risk for hepatitis B virus infection.      Objectives:      - To examine the long-term immune status of human immunodeficiency virus (HIV) positive and     negative individuals who received the hepatitis B vaccine during adulthood, compared with the     immune status of individuals who acquired natural immunity by recovering from acute hepatitis     B during adulthood.      Eligibility:        -  Individuals at least 18 years of age who were vaccinated against hepatitis B at least 10          years ago.        -  Individuals at least 18 years of age who contracted and recovered from acute hepatitis B          at least 10 years ago.        -  Individuals at least 18 years of age who have well-controlled HIV and were vaccinated          against hepatitis B at least 10 years ago.      Design:        -  Participants will have a single outpatient study visit and potential follow-up visits as          part of this protocol.        -  Participants will complete a questionnaire assessing possible risk factors for hepatitis          B infection, and will provide blood samples to test for hepatitis B antibodies and other          immune system studies.        -  Participants will receive a letter or phone call with the results of the blood tests:        -  Those who no longer have protective levels of antibody against the hepatitis B virus          will be offered a booster dose of the hepatitis B vaccine. To monitor immune response to          the booster vaccine, additional study visits will be scheduled at 1 and 3 weeks          following the booster.        -  Those who have chronic infection with the hepatitis B virus will be advised to follow up          with their primary care physician, and may be eligible to participate in ongoing          treatment trials for chronic hepatitis B.        -  Those who have abnormal blood tests will be referred back to their primary care          physician for investigation of the abnormal tests results, and may also be referred to          other National Institutes of Health protocols.        -  Additional tests will evaluate immune response to the measles, mumps, and rubella          (German measles) viruses. Some participants may be advised to have an additional MMR          vaccine through their primary care physician.   "
160531|NCT01182298|"     -  Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA)          to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who          have not been previously treated with interferon-alpha drugs (which improve immune          system response to infection). Ribavirin has been approved by the FDA and is usually          given in combination with interferon drugs such as peginterferon alfa-2a for treatment          of chronic HCV.        -  Recent research shows that Latino whites do not respond as well to treatment with          peginterferon alfa-2a and ribavirin as non-Latino whites. Various factors such as          excessive weight, gender, and insulin resistance were evaluated to explain this          difference, but research suggests that underlying factors related to Latino or          non-Latino background, possibly genetic and immune differences, may be affecting the          response to HCV infection and treatment. However, more research is needed on the          effectiveness of peginterferon and ribavirin in Latino subjects with HCV, and with          combined and human immunodeficiency virus (HIV) co-infection.      Objectives:      - To evaluate the safety, effectiveness, and viral response of peginterferon alfa-2a and     ribavirin therapy for chronic hepatitis C in Latino participants with and without HIV     co-infection.      This is an observational study. The observed treatment is received and managed through their     primary care.   "
160532|NCT01182285|"     Background:        -  Patients who have advanced thyroid cancer have a low long-term survival rate. These          types of thyroid cancer do not respond well to conventional surgery or radiation, or to          specific thyroid cancer treatments such as radioactive iodine treatment and thyroid          hormone for thyroid stimulating hormone (TSH) suppression.        -  Valproic acid has long been approved as an anticonvulsant to treat seizures in patients          with epilepsy. It has also been used to treat bipolar disorder. Recent studies have          shown that valproic acid has promising effects in thyroid cancer treatment because it          may help destroy cancer cells and help conventional treatments be more effective.          However, valproic acid is not approved for thyroid cancer and is therefore an          investigational drug.      Objectives:        -  To determine whether valproic acid can inhibit tumor growth or induce tumor cell death.        -  To determine whether valproic acid can make tumor cells increase their uptake of          radioiodine.      Eligibility:      - Individuals at least 18 years of age who have advanced-stage thyroid cancer that is either     unresponsive to conventional treatments or fails to absorb radioiodine.      Design:        -  Eligible participants will continue on the standard thyroid hormone suppression therapy          and begin receiving valproic acid for a total of 10 weeks. Participants will keep a          study diary to record doses and side effects, and will have regular clinic visits to          provide blood samples and receive additional valproic acid.        -  After 10 weeks, participants will have a Thyrogen scan to measure radioiodine uptake          after valproic acid therapy. Tumor biopsies and blood samples will be taken at this          time.        -  If there is increased radioiodine uptake on the scan, participants will have additional          radioiodine therapy.        -  If there is no increased uptake on the scan, participants will continue on valproic acid          for 7 more weeks. After 16 total weeks of treatment, additional blood samples and scans          will be taken. Participants may continue to take valproic acid if the thyroid cancer          appears to be responding to the treatment.        -  Follow-up visits will be scheduled at 3, 6, 9 (for patients continuing on valproic acid          only), and 12 months.   "
160533|NCT01182272|"     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating     patients with liver cancer that can be removed by surgery.   "
160534|NCT01182259|"     Tuberculosis remains one of the largest health problems in the world today. Multidrug therapy     is necessary to cure tuberculosis patients and to prevent the selection of drug-resistant     mutants, however, which may increase the incidence of side effects during the course of     treatment. These side effects may be mild as well as fatal. A severe side effect against one     of the anti-TB drugs, which influences drug compliance, may lead to the discontinuation of     that drug. At the same time, the risk of treatment failure and relapse are higher. Therefore     monitoring the rate of anti-TB drugs induced adverse effects and the related risk factors is     crucial. Awareness of the risk groups may decrease the incidence of serious drug-related side     effects and medical cost.      The fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended     by WHO, which simplify the prescription of drugs and prevent the development of drug     resistance. However, the FDC regimen is not consistent with the dosages that are usually     given, the higher risk of drug toxicity and adverse reactions should be considered. To our     knowledge, there was no report to assess the adverse effects of FDC anti-TB drugs in Taiwan.     The aim of the present study is to investigate the current incidence of side effects and the     risk factors related to FDC drugs for side effects during the initial phase of therapy.   "
160535|NCT01182246|"     The purpose of this study is to assess the effect and safety of AXP107-11 alone, and in     combination with gemcitabine standard therapy, in patients with advanced or metastatic cancer     of the pancreas. The safety, pharmacokinetics and efficacy of AXP107-11 in these patients     will also be studied.   "
160537|NCT01182220|"     1. labor epidural quite often require bolus supplementation for better pain control          control. Quite often this is due to sparing of sacral nerves.        2. If epidural is placed low in the L5/S1 interspace using ultrasound, this may minimize          bolus requirement and improve patient labor experience.   "
160538|NCT01182207|"     This study was designed to compare the relative bioavailability (rate and extent of     absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets     (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablets) in healthy, adult     subjects under non-fasting conditions.   "
160790|NCT00000227|"     The purpose of this study is to evaluate open buprenorphine dosing with dose choice.   "
160541|NCT01182168|"     The purpose of this study is to test the safety of gemcitabine and cisplatin plus Everolimus     (also called RAD001) at different dose levels. We want to find out what effects, good and/or     bad, this treatment has on you and your cancer.      Gemcitabine and cisplatin are standard chemotherapy drugs that are commonly used to treat     advanced urothelial cancer. Everolimus is a pill that works by shutting down some of the     pathways in cancer cells that make tumors grow. Laboratory studies have shown that Everolimus     appears to improve the activity of cisplatin against cancer cells.   "
160542|NCT01182155|"     Patients treated with radiation therapy for lung tumors can experience inflammation after     treatment. This study hopes to evaluate the use of breath analysis to evaluate changes in the     composition of exhaled breath in patients undergoing radiotherapy. If changes can be     detected, this may ultimately serve as biomarkers for identifying patients at highest risk     for radiation-induced lung injury (radiation pneumonitis).   "
160543|NCT01182142|"     Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of     metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic     renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine     in metastatic renal cell carcinoma patients.   "
160544|NCT01182129|"     Fifteen healthy smokers are given single doses of General Onyx 1 g portion snus and General     White 1g portion snus, respectively, and one piece of Nicorette 4 mg chewing gum. Serial     blood samples are drawn before (0), 2, 4, 8, 16, 24, 30, 45, 60 minutes, 1.5, 2, 4, 6 and 8     hours after administration for determination of nicotine. Mean + SD extracted dose of     nicotine from each preparation will be estimated. The percentage extracted of the nicotine     content will be calculated. Cmax and Tmax will be estimated. A comparison to Nicorette 4 mg     chewing gum will be made. The dose absorbed into the systemic blood circulation (AUC) in     relation to the dose following the 4 mg Nicorette chewing gum will be calculated.     Self-reports of subjective effects will be obtained up to 30 minutes after the test product     is administered using a 100 mm visual analogue scale (VAS) anchored with not at all to     extremely. Study hypothesis is that Cmax and AUC of Nicorette 4 mg chewing gum and Swedish     snus are similar.   "
160545|NCT01182116|"     The investigators hypothesis is that the patients who receive a side to end anastomosis have     bowel outcome and quality of life that is equivalent to those who receive a J pouch.   "
160546|NCT01182103|"     The investigators will (1) detect the associations between brain-derived neurotrophic factor     (BDNF) DNA methylation, histone modification, depressive symptoms, suicidal behavior and     antidepressant responses in major depressive disorder (MDD) patients, (2) check the     correlation between blood BDNF protein and RNA and BDNF rs6265 gene, and (3) discuss the     possible mechanisms of epigenetic regulation of BDNF in Taiwanese major depressive patients.   "
160547|NCT01182090|"     Objective:      This prospective randomized trial evaluated outcomes of colposacropexy performed either by     open or by conventional laparoscopic approach as therapy for uterovaginal prolapse. Surgical     techniques, efficacy and overall results are compared.      Methods:      In this prospective study 40 consecutive patients with uro-genital prolapse are randomized to     sacropexy: 20 by an open approach, 20 by a conventional laparoscopy approach. Anchorage is     achieved in both groups by two polypropylene meshes.      Check-ups were scheduled at 3, 6, 12 months and then yearly. Pre-operative patient     characteristics, operative and post-operative events and follow-up results are recorded.   "
160548|NCT01182077|"     The objective of the study is to characterize the effect of multiple doses of ASP015K on the     pharmacokinetics of a single dose of midazolam.   "
160549|NCT01182064|"     Patients with a cardiac stab wound could be complicated by a posttraumatic acute myocardial     infarction (PAMI). Traditionally, the investigators can explain it by the occlusion of a     coronary artery; but the PAMI isn´t constantly related with coronary artery injuries or their     damage in the cardiac injury repair. The investigators objectives are to know the PAMI     incidence, make an approximation to PAMI pathophysiology, and propose management strategies.   "
191611|NCT00353054|"     The aim of this study was to assess the effect of calcium/vitamin D supplementation (Caltrate     600 +D®) on body weight loss during a weight-reducing program   "
160553|NCT01182012|"     Background:      Patients with severe mental illness (SMI) have a higher prevalence of cardiovascular risk     factors (CVRF) than the general population and a control of these risk factors poorer.     Serious mental illness often causes health teams to focus interventions in mental illness and     put aside the CVRF.      Objectives:      This project aims to assess the CVRF, stratify the cardiovascular risk, adequate drug     treatment to reduce this risk and evaluate the effectiveness of an intervention by     professional community nurses in patients with SMI.      Materials and Methods:      Prospective study of a cohort of patients over 18 years with a diagnosis of SMI with two     cross sections to evaluate the cardiovascular risk and adequacy of drug treatment. The     investigators calculate the risk to the cardiovascular risk tables with the SCORE (Systematic     Coronary Risk Evaluation) for countries of low cardiovascular risk and the of Framingham     REGICOR (Heart registry of Girona, Spain). The adequacy of pharmacotherapy will be assessed     contrasting it with the recommendations of the Program of Preventive Activities and Health     Promotion of Family medical association. The intervention will be conducted by professional     nurses and consist of an initial psycho-educational intervention, and two more reinforcement     throughout twelve months, of duration less than 30 minutes that will be addressed in an     integrated manner the clinical situation with regard to cardiovascular risk. If necessary,     pharmacological treatment will be prescribed. Twelve months after the first intervention, a     second evaluation on cardiovascular risk and the effectiveness of the intervention will be     performed.   "
160554|NCT01181999|"     Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)     combination is considered as the new gold standard for the first-line treatment of elderly     patients with diffuse large B-cell lymphoma (DLBCL).      The study is aimed to evaluate the overall response rate and the safety of four cycles of     R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in     newly diagnosed DLBCL patients with aged more than 70 years.   "
160586|NCT01181583|"     The overall aim of this study is to develop and test a tailored Internet-delivered     psychological treatment for patients with mild to moderate major depression and comorbid     anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active     control group.   "
160555|NCT01181986|"     The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes     medication, will improve the function of the innermost part of the arterial wall called the     endothelium after a fat-enriched meal and to determine how this occurs. The results of this     study will help to determine and understand a novel action of this group of diabetes     medications based on the action of naturally occuring gut substances called incretins. This     may have a significant impact on cardiovascular health in patients with early and     longstanding diabetes.   "
160556|NCT01181973|"     The hypothesis to be tested is that the bioavailability of the new 30-mg vial is similar to     that of the current approved 15 -mg vials. In addition, the SC injection using the new 30-mg     vial is safe and well-tolerated.   "
160557|NCT01181960|"     The purpose of this study is to build a data repository that can be used to understand     pharmaceutical utilization patterns among patients being treated in community behavioral     health organizations (CBHOs) for schizophrenia or bipolar I disorder.   "
160558|NCT01181947|"     The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System     (Captivia). This new delivery system was CE marked on September 14th, 2009 and was     commercially released in the European Union on October 1st, 2009.      The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is     designed to treat diseases of the descending thoracic aorta including but not limited to     aneurysms and dissections.      The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical     performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market     approval.   "
160559|NCT01181934|"     This study in young and elderly healthy subjects will investigate the effect of nicotine on     arousal, cognitive task and social cognition after acute dose administration.   "
160560|NCT01181921|"     The purpose of this study is to assess the modulating effect of galantamine on circadian     rhythm in patients with moderate Alzheimer's disease.   "
160561|NCT01181908|"     The purpose of this study is understand the effects of GSK114814 and alcohol in healthy     volunteers when taken together.   "
160562|NCT01181895|"     The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation     powder administered once daily in the evening in adolescent and adult subjects 12 years of     age and older with persistent asthma over a 12-week treatment period.   "
160563|NCT01181882|"     The purpose of this study is to understand if omega-3 fatty acids in fish oil enhance the     ability of aspirin to reduce the risk of cardiovascular diseases such as heart attack and     stroke in those who have diabetes mellitus.   "
160564|NCT01181869|"     An observatory of patients registered in 22 local homecare associations in France, for     respiratory diseases, with annual data update. Demographic and clinical data are registered     rendering possible extraction of clinical and prognostic data.   "
160565|NCT01181856|"     This is a phase I study that will compare the safety and immunogenicity of candidate     tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal     route in healthy adult individuals who have been previously vaccinated with Bacillus     Calmette-Guerin (BCG).   "
160566|NCT01181843|"     This study is designed to determine the incidence and severity of respiratory depression in     elective cesarean section patients who have received a spinal or epidural narcotic called     duramorph for management of postoperative pain. A monitoring device called a capnograph as     well as a device called a pulse oximeter is placed on the patient once in the recovery room     after delivery. The capnograph monitors the carbon dioxide level that the patient breathes     out as well as their respiratory rate. The pulse oximeter is a device that is taped on the     patient's finger and measures their oxygen saturation level. The monitoring is maintained for     18-24 hours after surgery.   "
160609|NCT01181284|"     Patients with pulmonary arterial hypertension(PAH) suffer from chronic shortness of breath,     and have impaired survival related to progressive right ventricular failure. Abnormal     vasoreactivity to nitric oxide(NO) plays a role in the pathophysiology of PAH.     Phosphodiesterase Type 5 Inhibitor (PDE5 inhibitors) sildenafil have been shown to be     beneficial in PAH, but extent of benefit is variable.   "
160761|NCT00000198|"     The purpose of this study is to evaluate the effects of IV cocaine administration in cocaine     dependent subjects maintained on piracetam while they are residing in an inpatient addictions     treatment research unit and to subsequently follow these patients in an eight week open label     assessment of piracetam in an outpatient treatment program.   "
160567|NCT01181830|"     Magnesium is the second most abundant ion in human cells and plays fundamental roles in     several enzymatic reactions: it is involved in ATP production, in the phosphorylation of     proteins, in glucose metabolism and in the contraction of cytoskeleton.      Several epidemiological studies demonstrated that low dietary magnesium intake is inversely     associated with diabetes mellitus, hypertension and metabolic syndrome.      Magnesium could be related to important haemodynamic and metabolic anomalies: at vascular     level it acts as an antagonist of calcium, especially in vascular smooth muscle cells, thus     its deficit could enhance vascular contraction; with regard to glucose metabolism, magnesium     is involved in the physiopathological mechanism of insulin resistance, through a reduction in     cellular uptake of glucose. This condition and the subsequent compensatory hyperinsulinemia     can ultimately lead to increased synthesis of proinflammatory cytokines and to endothelial     dysfunction. Thus, magnesium depletion and subsequent alterations can increase the risk of     developing vascular disease such as atherosclerosis and has been associated with     cardiovascular events.      Several clinical trials have explored the possible beneficial effect of magnesium     supplementation on blood pressure, plasma lipids and insulin resistance but the results are     often contradictory. One of the possibilities for these unclear results could be that in some     of them the interventions started too late when haemodynamic and metabolic changes are more     difficult to revert.      The investigators hypothesis is that magnesium supplementation in a population at increased     genetic risk of developing metabolic syndrome but without it could improve blood pressure and     the other metabolic syndrome related components.      Thus, the aim of the present study is to evaluate the effect of oral supplementation of     magnesium (16.2 mmol/day of magnesium pidolate) on metabolic syndrome's components in a     sample of 15 subjects who are at increased risk of developing metabolic syndrome since have a     positive familiar history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI     criteria).   "
160568|NCT01181817|"     Functional Magnetic Resonance Imaging (fMRI)and MR Spectroscopy of the brain are perfect     tools to investigate the changes in the brainstem and brain evoked by the orthodromically     impulses of a SCS.   "
160569|NCT01181804|"     This is a single-dose, randomized, cross-sectional comparison study examining the relative     safety and resulting blood level profiles after administration of a new boceprevir tablet     formulation versus its current capsule formulation for treatment of chronic hepatitis C. In     Part 1 of the study participants will receive boceprevir tablets and capsules under fed     conditions. In Part 2 of the study a new group of participants will receive boceprevir     tablets and capsules under fasted conditions.   "
160570|NCT01181791|"     This application a phase II clinical trial to address the possible active mechanisms of     probiotics and to obtain preliminary efficacy and safety data after the administration of a     probiotic, Lactobacillus reuteri a population of premature infants.      The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature     infants will lead to clinical beneficial effects by modifying their intestinal microbiota and     enhancing their intestinal immunological response.   "
160571|NCT01181778|"     Physicians counsel women participants who are candidates for hormonal contraception about     available combined hormonal contraceptive methods (the combined pill, the contraceptive     vaginal ring [i.e., the etonogestrel + ethinylestradiol vaginal ring] and the contraceptive     transdermal patch). Effects of this counseling on women's contraceptive use decisions are to     be evaluated by 1) recording which method is chosen after information is provided about all     three available combined hormonal methods, 2) comparing the final chosen contraceptive method     used by a participant after counseling with the method originally intended to be used by that     participant before the counseling, and 3) evaluating the criteria used by women participants     to choose their contraceptive method after the counseling, including evaluation of social and     demographic predictors of contraceptive choice. The differences among participants in the     number of contacts made by the participants to physician offices for purposes of obtaining     information regarding the use of their final chosen hormonal contraceptive (e.g., requests     for clarification, questions, expressing doubt or reservations for using the method, or     requests for other help/advisement by the physician) will also be evaluated over four months     following the physician counseling.   "
160572|NCT01181765|"     This is a pilot study to estimate the efficacy of infliximab in inducing and maintaining     healing of lesions in the mucosa of subjects with Crohn's disease involving their small     bowel.   "
160573|NCT01181752|"     Eye drops must be proficiently instilled to prevent infections following cataract surgery.     Proficiency is defined as placing a drop on the ocular surface without touching the     applicator's tip. Researchers will investigate whether patients can proficiently administer     eye drops on the first attempt on the first day after surgeries. If successful, researchers     will determine how proficient they are 29 days later. If not, they will be provided with     additional educational sessions and tested again 29 days later. Researchers will also     determine if the proficiency of instillation correlates to whether patients experience     irritation or pain after surgery.      Summary Brief Summary Eye drops must be proficiently instilled to prevent infections     following cataract surgery. Proficiency is defined as placing a drop on the ocular surface     without touching the applicator's tip. Researchers will investigate whether patients can     proficiently administer eye drops on the first attempt on the first day after surgeries. If     successful, researchers will determine how proficient they are 29 days later. If not, they     will be provided with additional educational sessions and tested again 29 days later.     Researchers will also determine if the proficiency of instillation correlates to whether     patients experience irritation or pain after surgery.      Hypotheses:      On postoperative day 30, there will be a higher rate of successful eye drop instillation in     the group of subjects who receive the educational session compared to the baseline group     subjects (subjects only tested on postoperative day 30 rather than both the first day after     surgery and postoperative day 30) who will not receive it.      In comparing the postoperative day 30 proficiency levels of baseline subjects and subjects     who were able to proficiently instill a single eye drop on postoperative day 1, the subjects     who were able to proficiently instill a single eye drop on postoperative day 1 will have a     higher success rate than the baseline group.      The number of subjects who are unable to correctly instill the medication on postoperative     day 30 and experienced pain or irritation before or during postoperative day 30 will be     higher than the number of subjects who are able to correctly instill the medication on     postoperative day 30 and experienced pain or irritation before or during postoperative day     30.   "
160574|NCT01181739|"     This study is designed to compare traditional Colonoscopy with CT Colonography, commonly     known as virtual colonoscopy. The study will compare the ability of both procedures as     screening tests to identify polyps in the colon in patients at average risk for developing     polyps. The patient preferences for each procedure will be assessed by means of a     standardized questionnaire. As well the ability observers with differing levels of experience     to read the CT scans and detect polyps will be compared. All patients will receive both CT     scans and traditional colonoscopy on the same day.   "
160575|NCT01181726|"     The objective of this study was to determine and compare the rate and extent of absorption of     norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone     Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg     norethindrone acetate) Tablets under fed conditions.   "
160576|NCT01181713|"     The purpose of this study is to determine if antibiotic resistance of the ocular surface     flora to the 4th generation fluoroquinolones will increase after repeated use of topical     antibiotics for three days post intravitreal injection.   "
160577|NCT01181700|"     The purpose of this study is to investigate the time course of PF-00241939 concentrations in     the blood following dosing by oral inhalation using dry powder inhalers.   "
160578|NCT01181687|"     The purpose of this study is to establish reliability and validity of the Norwegian version     of the Comfort behavioral scale.   "
160579|NCT01181674|"     The purpose of this pilot trial is to determine whether an intensive treatment with insulin     glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients     with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.   "
160580|NCT01181661|"     The purpose of the study is to develop and test an Internet-based group contingency     management program designed to promote smoking cessation.   "
160581|NCT01181648|"     The investigators are doing this study to learn about the quality of life patients have at     the end of treatment. Some patients' cancers are related to human papilloma virus or HPV;     others are not. HPV is a virus that can be sexually transmitted and is known to cause some     types of cancers. If your throat cancer was related to HPV, your doctor can discuss this with     you in detail. The investigators want to see if there are differences in quality of life     between patients whose cancers are caused by HPV and those who cancers are not caused by HPV.     Throat cancers caused by HPV behave differently than throat cancers not caused by HPV. The     investigators believe that patients with these two different types of throat cancer will also     have different experiences after completing therapy. The investigators would like to     understand what those differences are. The long-term goal of this study is to see what     symptoms most patients have. The investigators can then try to treat them earlier, and     hopefully, improve the symptoms. The investigators will also be able to plan more research to     improve treatment for symptoms following treatment for cancer of the mouth and throat.   "
160582|NCT01181635|"     The purpose of this study is to examine if psychotherapy can reduce sickness absence.   "
160583|NCT01181622|"     The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID     in pediatric CF patients 2 to 4 years of age   "
160584|NCT01181609|"     This study will assess the efficacy and safety of intravenous Avastin in combination with     chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum.     The anticipated time of study treatment is until disease progression.   "
160585|NCT01181596|"     Use of a new ultrasound device designed for babies to look at the catheters in veins and     arteries as well as the blood vessel itself. An observational study to assess the the     clinicians perception of the ultrasound image quality as a tool to detect catheters in     vessels.   "
160587|NCT01181570|"     This study will evaluate the effect and safety of adalimumab in approximately 20 subjects     with mild to moderate psoriasis and sleep apnea and will be conducted in one treatment center     located in Montreal.      Patients with psoriasis often have additional disorders such as obesity. Obese patients are     more at risk of developing obstructive sleep apnea. This is believed to be caused by both the     collapse of upper airways and inflammation (swelling). Adalimumab, a drug currently approved     by Health Canada for the treatment of psoriasis, blocks tumor necrosis factor-alpha     (TNF-alpha). This chemical is present at higher levels in patients with sleep apnea. It is     believed that adalimumab could improve obstructive sleep apnea by lowering the levels of     TNF-alpha.   "
160588|NCT01181557|"     The aim of the present prospective study was to evaluate the prediction accuracy of EORTC     QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to     investigate how the quality of life (QoL) of patients with rectal cancer changes with time     after cancer or after stomia.      Eligible subjects were consecutively enrolled in the investigators' Institute and subjected     to EORTC QLQ-C30/C38 questionnaire.   "
160589|NCT01181544|"     During hemodialysis treatments, patients receive heparin to prevent clotting. The purpose of     this pilot study is to determine if the amount of heparin administered during a patient's     hemodialysis can be individualized using an equation for heparin dose adjustment.   "
160590|NCT01181531|"     The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage     plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally     or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the     doses are adjusted appropriately to maintain serum calcium and phosphorous levels with     currently recommended ranges.   "
160591|NCT01181518|"     The clinical outcome of tamoxifen treatment in breast cancer patients may be influenced by     the activity of cytochrome P450 enzymes involving in tamoxifen biotransformation.   "
160592|NCT01181505|"     This study was to investigate the pharmacokinetics of tolterodine, substrate of CYP2D6 in     healthy subject in relation to the presence of HNF-4A G60D variant.   "
160593|NCT01181492|"     Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on     metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176     patients receiving elective lower abdominal surgery under general anesthesia were recruited     into this study. Genotyping of CYP3A4*1G was carried out by direct sequencing. The plasma     fentanyl concentration was detected 30 min after anesthesia induction by high performance     liquid chromatography-ultraviolet ray (HPLC-UV). The visual analog scale (VAS) was used for     pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24     h after operation. PCA fentanyl consumption and adverse effects were recorded during the     first 24 h after surgery.   "
160594|NCT01181479|"     The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal     contraceptive delivery system containing ethinyl estradiol and levonorgestrel.   "
160595|NCT01181466|"     The purpose of this study is to assess the procedural and post-procedural safety and efficacy     of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with     GOLD Stage III/IV homogeneous or heterogeneous emphysema.   "
160596|NCT01181453|"     This study randomly assigns patients with diabetic foot ulcers to receive standard therapy     (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus     Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an     absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment     period is complete.   "
160597|NCT01181440|"     This study randomly assigns patients with plantar diabetic foot ulcers to receive     conventional therapy (debridement, infection control, saline-moistened gauze dressings, and     standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a     device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh.     Patients are evaluated weekly until Week 12, then every four weeks until Week 32.   "
160598|NCT01181427|"     Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected     subjects.   "
160600|NCT01181401|"     This is an open-label, randomized, Phase II-study to evaluate the efficacy of a standard-TPF     induction chemotherapy (IC) and an alternative TPF induction chemotherapy followed by     radio-antibody-therapy, in patients with unresectable LA-SCC of the HN region     (oro-hypopharynx carcinoma, cancer of the oral cavity).      The primary objective of the study is to assess the feasibility of an experimental     'fractionated' TPF regimen compared to a current standard TPF regimen.      Composite endpoint of compliance and feasibility in terms of        -  response (RECIST1.1) and        -  hematological acute toxicity (CTCAE v.4.02)        -  on time application of RAT following an experimental or standard TPF IC.      Secondary endpoints are        -  Treatment intensity achieved        -  Toxicity (according to CTCAE v.4.02)        -  Response rates after completion of induction chemotherapy and after completion of entire          protocol treatment (RECIST1.1)        -  Survival (progression-free, metastasis-free, recurrence-free, overall) 1 year after          randomisation        -  Quality of life according to EORTC QoL C30 & HN35      The study will be conducted at 5-6 investigational sites in Germany recruiting 90 patients in     total. Eligible patients will have a diagnosis of histologically confirmed SSC of the HN.     Patients will receive one of 2 different regimens of TPF IC followed by cetuximab together     with radiotherapy (RAT) or a standard radiochemotherapy(RCT) regimen.   "
160601|NCT01181388|"     Superselective IRA infusion of tirofiban may improve myocardial reperfusion and reduce     bleeding complications in AMI patients.   "
160602|NCT01181375|"     The experiments outlined in this proposal will compare a number of currently available     techniques for assessing hypoxia and interstitial fluid pressures in patients with cervix     cancer. The aim of these experiments is to establish the relationship of the clinically     relevant outcome measures of tumour control and survival following radiation therapy with     these biological characteristics of carcinoma of the cervix relevant to tumour hypoxia. These     characteristics will be assessed in patients undergoing treatment using techniques which have     reached an appropriate level of development for clinical evaluation and aim to determine the     best technique for determining these parameters of the tumour microenvironment. A number of     novel strategies directed at the microenvironment are undergoing or soon will be undergoing     clinical evaluation and selection of appropriate patients for these trials is of great     importance.   "
160603|NCT01181362|"     Intensity Modulated Radiation Therapy planning is based on CT images, with tumour volumes     defined on this volumetric information data set. However, target delineation also depends on     disease seen endoscopically which may not be visible on CT. We are developing imaging and     tracking technology to improve target delineation in Radiation Therapy (RT) planning for head     & neck cancer using quantitative registration of 2D endoscopic information with CT data.     Diagnostic endoscopy is performed in the upright position. CT images and radiation delivery     are obtained with the patient in the supine position. The accuracy of the registration will     be improved if performed in the same position to prevent mobile soft tissue structures     shifting between the upright and supine positions. Since therapy must be performed in the     supine position, we intend to check the feasibility of performing endoscopy in the supine     treatment position. We will compare and assess patient comfort and endoscopic sightlines     during an endoscopy procedure in both the upright and supine positions.   "
160604|NCT01181349|"     This is a multicenter, observational study in adult participants undergoing different types     of elective surgical procedures requiring general anesthesia. During the first study period,     there will be a cross-sectional evaluation of neuromuscular blockade level upon participant     arrival at Post Anesthesia Care Units (PACUs). During the second study period, hospital     discharge data from the participants will be collected. The purpose of this study is to     determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia at     PACUs in Portuguese hospitals. This is a cross-sectional and retrospective study.   "
160605|NCT01181336|"     The purpose of this study is to see whether a single vaccination (injection) with the     investigational influenza vaccine is safe in healthy subjects. The study is also designed to     evaluate four different dose formulations of the vaccine to see which gives the best immune     response.   "
160606|NCT01181323|"     The purpose of this research study is to learn more about the safety of 2 licensed flu     vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to women     who are breastfeeding and to compare the immune response (body's defense against foreign     substances) of breastfeeding mothers, who receive intranasal flu vaccine, with breastfeeding     mothers receiving the flu vaccine shot. Healthy women (240 volunteers, 28-120 days post     delivery) who plan to breastfeed through 28 days post vaccination and who have not received     influenza vaccine for the influenza season for which they are being enrolled, will be     assigned by chance to 1 of the 2 vaccines in the following manner: flu vaccine nasal spray     and a placebo (inactive substance) shot or a flu vaccine shot and a placebo nasal spray.     Study procedures include: nasal swabs, blood samples, and completion of memory aids.     Participants will be involved in this United States based study for about 6 months.   "
160607|NCT01181310|"     The drug, scopolamine, can result in short-term impairments of cognitive function, attention,     and memory that resemble those seen in aging and Alzheimer's disease. This study tested the     capability of both individual and combined doses of MK-3134 and the current standard     treatment: donepezil (Aricept), to reverse such impairments, following a single dose of     scopolamine. Participants were evaluated after each of 5 different treatment periods (in a     cross-over, double-dummy design): A: placebo to match both donepezil (oral [PO]) and MK-3134     (PO) followed by placebo scopolamine (subcutaneous [SQ]); B: placebo to match both donepezil     (PO) and MK-3134 (PO), followed by scopolamine SQ; C: MK-3134 (PO) followed by scopolamine     SQ; D: donepezil (PO) followed by scopolamine SQ; E: MK-3134 (PO) and donepezil (PO) followed     by scopolamine SQ. The doses of MK3134, donepezil, and scopolamine were the same over all     treatment arms in which the specified drug was administered. There were 8 total visits for     each treatment period, including 5 Treatment Visits requiring 14-day intervals between visits     for study-drug washout. Participants were assessed for cognitive function before and after     each treatment period during the Treatment Visits.   "
160608|NCT01181297|"     The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed     formula with an added probiotic in children with documented milk allergy.   "
160762|NCT00000199|"     The purpose of this study is to follow patients in Phase I of an inpatient study in an eight     week open label assessment of piracetam in an outpatient treatment program.   "
160610|NCT01181271|"     Relapse remains a principle cause of treatment failure for patients with aggressive lymphoma     after autologous transplantation. Non-myeloablative allogeneic transplantation allows     patients to receive an infusion of donor cells in an attempt to induce a graft versus     lymphoma effect. This study will assess the feasibility, safety and efficacy of the     combination of autologous stem cell transplantation followed by non-myeloablative     transplantation for patients with poor-risk aggressive lymphoma.   "
160611|NCT01181258|"     In this study the investigators investigate a cell therapy strategy that could harness     allogeneic effectors that can potentially mediate anti-lymphoma effect. The investigators     have designed a novel lymphodepleting conditioning regimen followed by infusion of     donor-derived natural killer (NK) cells and interleukin-2 (IL-2) for patients with refractory     lymphoid malignancies.   "
160612|NCT01181245|"     Objectives        -  Primary: To evaluate the safety and tolerability of FG-3019 in combination with          gemcitabine and erlotinib        -  Secondary: To evaluate the efficacy and pharmacokinetics of FG-3019 in combination with          gemcitabine and erlotinib   "
160613|NCT01181232|"     The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified     release) compared to zolpidem IR (immediate release) in patients with primary insomnia.   "
160614|NCT01181219|"     Transepithelial CXL (performed without epithelial removal) seem to have similar clinical     effect on keratoconic eyes compared to the standard CXL (which includes epithelial removal).     The current study attempts to prove that hypothesis.      A prospective, controlled, randomized, contralateral trial, will involve one eye of the     patient to be treated with transepithelial CXL, while the control eye will be treated with     the standard CXL. Totally 20 patients (age >18 and <40 years) referred by an ophthalmologist     to the eye department of the University Hospital North Norway for CXL treatment of bilateral     progressive keratoconus, will be recruited.   "
160615|NCT01181206|"     BaFo is a prospective, double-blinded randomized controlled clinical trial that assesses the     numbers of surgical site infections in two different techniques of covering the abdominal     wall in laparotomies. Standard covering with woven swabs is compared to a novel, approved 3M™     Steri-Drape™ Wound Edge Protector.   "
160616|NCT01181193|"     This is non-randomized phase 2 study to assess efficacy and toxicity of long term high dose     vitamin D3 given concurrently with chemo-radiotherapy (CCRT) containing temozolomide followed     by adjuvant chemotherapy (ACT) with temozolomide in patients with newly diagnosed     glioblastoma multiforme GBM). Preoperative diagnosis of GBM will be based on magnetic     resonance imaging (MRI) brain scan. All patient will underwent craniotomy with partial or     total resection of a visible tumour mass. All patients will be planned for postoperative     three-dimensional conformal RT (3-DCRT) or intensity-modulated RT (IMRT) to residual tumour     and/or resection bed. A total RT dose of 54-60 Gy will be delivered using 2 Gy daily     fractions given over 5 days a week. Daily chemotherapy with temozolomide in the dose of 75     mg/m2/day will be started at the first day of RT, and will be continued for entire period of     RT inclusive week-end breaks. ACT will contain 6 cycles of oral temozolomide 150-200     mg/m2/day given for 5 days every 4 weeks. Oral vitamin D3 will be administered in daily dose     of 4000 IU. Vitamin D3 therapy will be started 1 week prior to commencing CCRT, and will be     terminated immediately after completing last cycle of ACT. MRI scan of the brain will be     performed at 4 months after completing CCRT, and than will be repeated every 4 months for     first 2 years, and every 6 months for subsequent years. The study participants will be     followed until disease progression or death. The study is expected to complete within 4     years.   "
160617|NCT01181180|"     Experimental design overview The proposed project is a prospective experimental RCT study     design. Independent old adults(age 65 years old and older) who do not suffer from balance     problems willing to participate in the study will be tested before and after water     consumption to explore whether there are differences in balance control as a result of     dehydration.   "
160618|NCT01181167|"     The objective of this study is to assess the efficacy and safety of DU-176b compared with     enoxaparin sodium for the prevention of venous thromboembolism in patients after elective     total hip arthroplasty.   "
160619|NCT01181154|"     The hypothesis based on retrospective data is that, the rate of overall response-rate (PR +     CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm     (20%).Thirty four patients (17 in each arm) will be include (amendment n°6 - 15/10/2013) over     a 3 year period (amendment n°3 - 11/12/2012).   "
160620|NCT01181141|"     The objective of this study is to evaluate the safety and efficacy of DU-176b compared with     enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip     fracture surgery.   "
160621|NCT01181128|"     The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc     administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical     treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm     1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical     treatment regimen. The secondary objectives of this study are: to characterize the PK profile     of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to     characterize the range of dose and schedules required to adequately prevent bleeding in a     prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes     in an on-demand, weekly treatment, or prophylaxis setting.   "
160622|NCT01181115|"     The study is designed to determine the effect of weekly intramuscular (IM) administration of     30 mcg Avonex (interferon beta 1a) on safety parameters and gadolinium (Gd) enhanced and     T2-weighted cranial magnetic resonance imaging (MRI) lesions in Chinese patients with     clinically diagnosed (using revised McDonald criteria) relapsing multiple sclerosis (MS).   "
160623|NCT01181102|"     The objective of this study is to assess the efficacy and safety of DU-176b compared with     enoxaparin sodium for the prevention of venous thromboembolism in patients after elective     total knee arthroplasty.   "
160624|NCT01181089|"     This is a prospective, randomized, multicenter, dose escalation study to determine subject     safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS   "
160642|NCT01180855|"     The specific aims of the proposed study are to compare the sleep, daytime functioning, and     circadian phase effects of ROZEREMTM (ramelteon/TAK-375) a selective MT1/MT2 melatonin     receptor agonist in humans alone and in combination with multi-component behavior therapy     (MCBT) in patients with chronic insomnia.   "
160625|NCT01181076|"     Aim      Allogeneic stem cell transplantation (allo-SCT) combined with several cycles of intensive     chemotherapy is the only curative treatment for several malignant blood diseases. Most     allo-SCT patients who are treated with intensive chemotherapy often have reduced nutritional     status. Several studies have evaluated the effect of different nutrition intervention for     allo-SCT patients, but there have not been found evidence-based recommendations for energy     requirements, use of enteral nutrition (EN) and/or parenteral nutrition (PN). We are not     aware of studies using QoL as end-point among allo-SCT patients allocated to specific     nutrition intervention.      Main hypothesis:      Patients who receive individualized nutrition have better global QoL assessed with the     European Organisation for Research and Treatment in Cancer (EORTC) QLQ-HDC29 tool three     months after SCT      Sub-hypotheses:      Patients who receive individualized nutrition have:      i) less often oral mucositis grade 3-4. ii) better nutrition status iii) decreased length of     hospital stay, less episodes with fever, earlier engraftment and less often acute graft     versus host disease (GVHD) grade 3-4, and iv) better main QoL scores on the scale for     physical and social functions, fatigue, loss of appetite, nausea/vomiting and diarrhoea three     months after allogeneic SCT, compared to the control group.      Patients and methods A minimum sample of 100 patients will be included in the study. The     patients enrolled in the study will be randomly assigned to the intervention- or control     group. The patients in the intervention group will receive a therapeutic diet in combination     with tube feeding with an additional PN if the estimated requirements by the enteral route is     lower than reference values. The patients in the control group will receive nutrition support     after established routine, first by the oral route, later by the PN route.   "
160626|NCT01181063|"     Due to the complexity of orally inhaled products (combination of a formulation and a     device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo     correlation(IVIVC) for inhaled dosage forms is not generally known.      The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH     product variants under development and compare pulmonary deposition (administration with     charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.   "
160627|NCT01181050|"     This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy     of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis     (RA).   "
160628|NCT01181037|"     A retrospective study to compare clinical results of patients that were treated by Bipolar     H.A. vs. closed reduction and internal fixation with Trochanteric Antegrade Nail for     displaced femoral subcapital fracture.   "
160791|NCT00000228|"     The purpose of this study is to compare overall treatment outcome between behavioral versus     standard treatment types.   "
160629|NCT01181024|"     This randomized, double-blind, placebo controlled, 3 part study will assess the safety,     tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with     chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized     to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers will     receive a single dose of RO5303253 or placebo in a cross-over design (with a washout period     of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients with     chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5 days.   "
160630|NCT01181011|"     To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose     combination after single dose in healthy Chinese subjects.      To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine,     following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and     in combination, in healthy Chinese subjects.      To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy     Chinese subjects.   "
160631|NCT01180998|"     The purpose of this study is to evaluate the clinical performance, defined as successful fit,     of two toric contact lenses (one daily disposable and the other daily wear reusable contact     lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens     drop-outs, and non-users of toric contact lenses (neophytes).   "
160632|NCT01180985|"     The purpose of this study is to compare visual acuity and redness of eyes between a prototype     contact lens and an already marketed contact lens.   "
160633|NCT01180972|"     This is a pilot community-based research study to examine the effects of specific     environmental and social factors on physical activity, fitness, and health of middle school     Hispanic children living in an inner-city community.   "
160634|NCT01180959|"     The goal of this clinical research study is to learn if the combination of AvastinTM     (bevacizumab) and Tarceva (erlotinib hydrochloride) can help to control advanced liver     cancer. The safety of this drug combination will also be studied.   "
160635|NCT01180946|"     Fibroblast growth factor 23 (FGF23) is a newly discovered hormone which regulates phosphate     and vitamin D levels. In this study, we are looking at what the normal levels of FGF23 are in     adolescent girls and how these levels vary with other hormonal measurements. We will also be     looking at whether vitamin D supplementation in adolescents who are deficient in vitamin D     alters the levels of FGF23 and other factors including insulin resistance.   "
160636|NCT01180933|"     Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid,     both or a placebo during the second half of pregnancy. Biochemical measures are determined in     maternal blood during pregnancy and in cord blood.      Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years     focus on long term effects of supplementation anthropometric development, neurological     development and allergy risk.   "
160637|NCT01180920|"     The goal of this study is to determine the clinical importance of Periostin in oral health     and disease. The long-term goal will be to develop practical applications for the diagnosis,     treatment, prevention and cure of human periodontal diseases.   "
160638|NCT01180907|"     The purpose of the study is to determine whether positron emission tomography using the new     imaging agent 18F-FAC can be used for imaging cancer and/or inflammation.   "
160639|NCT01180894|"     The purpose of this clinical trial is to determine whether intravenous iron supplementation     of anemic, critically ill trauma patients improves anemia and reduces the need for a red     blood cell transfusion.   "
160640|NCT01180881|"     The aim of this study is to follow up with all of the pediatric brain tumor patients who     received proton beam radiation therapy at Massachusetts General Hospital (MGH) for which     there is baseline neuropsychological testing in order to measure changes, if any, in     neurobehavioral functioning (executive skills, emotional/behavioral functioning, and adaptive     abilities) and their use of special education services at one year or more post-treatment.     The investigators will also correlate neurobehavioral data with pertinent clinical     information. Participation will be maximized through the use of mail-in, parental- and     self-report questionnaires.   "
160641|NCT01180868|"     The purpose of this study is to determine the biodistribution of a new agent 1-L-(2     deoxy-2,-18fluoroarabinofuranosyl) cytosine non-invasively in healthy humans and to evaluate     whether it can be used to image cancer, autoimmune disease, and inflammation   "
160643|NCT01180842|"     The investigators research question is whether or not yoga effectively alleviates symptoms of     pain, sleep disturbance, anxiety and depression in children with cystic fibrosis. If yoga     does prove to be effective, the investigators will educate our CF population about the     benefits they may experience if they choose to incorporate yoga into their CF therapy. The     investigators will also go on to do further research of other complementary alternative     medicine therapies.      This is a pre/post-test study with 20 subjects. The subjects will serve as their own     controls. Each subject will participate in six yoga sessions over a ten week period.     Subjects' symptoms will be evaluated with the use of questionnaires. The investigators will     also test cortisol levels on weeks -2, -1, 1, 6, 7, 8. Cortisol is a hormone that is affected     by stress. Testing of cortisol throughout the study will help us determine the subjects'     stress level throughout the study.   "
160644|NCT01180829|"     This study will provide a pilot test of two different text message interventions for problem     drinkers. Participants will be recruited using a general population telephone survey.     Participants in a control group (who will not receive text messages) will be compared to     participants who receive one of two different types of text message packages (12 text     messages sent once per week in each) - a series of personalized feedback text messages or a     series of consciousness raising test messages (i.e., messages that keep the thought of     cutting down on their drinking in the participants' mind). Participants in the three     different conditions will be followed-up in three months time to assess changes in drinking.     It is predicted that participants who receive either of the text message packages will report     reduced drinking as compared to those participants in the control condition who do not     receive any text messages.   "
160792|NCT00000229|"     The purpose of this study is to compare overall treatment outcome between behavioral versus     enhanced behavioral treatment types.   "
160793|NCT00000230|"     The purpose of this study is to evaluate buprenorphine and behavioral treatment with and     without contingent payment on compliance with naltrexone.   "
160645|NCT01180816|"     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of     tumors also exhibits the most aggressive behavior, resulting in median overall survival     durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy has consisted of     surgical resection, external beam radiation or both. More recently, a Phase 3 clinical     published by Stupp et al in 2005 showed a benefit for using radiotherapy plus concomitant and     adjuvant Temozolomide. Still, all patients experience a recurrence after first-line therapy,     so improvements in both first-line and salvage therapy are critical to enhancing     quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV)     therapies even cross the blood brain barrier (BBB). Superselective Intra-arterial Cerebral     Infusion (SIACI) is a technique that can effectively increase the concentration of drug     delivered to the brain while sparing the body of systemic side effects. One currently used     drug called Temozolomide (Temodar) has been shown to be active in human brain tumors but its     actual CNS penetration is unknown. This phase I clinical research trial will test the     hypothesis that following the standard 42 day Temozolomide/radiotherapy regimen, Temozolomide     can be safely used by direct intracranial superselective intra-arterial cerebral infusion     (SIACI) up to a dose of 250mg/m2, followed by the standard maintenance cycle of temozolomide     to ultimately enhance survival of patients with newly diagnosed GBM/AA. The investigators     will determine the toxicity profile and maximum tolerated dose (MTD) of SIACI Temozolomide.     The investigators expect that this project will provide important information regarding the     utility of SIACI Temozolomide therapy for malignant gliomas, and may alter the way these     drugs are delivered to our patients in the near future.   "
160646|NCT01180803|"     The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems     using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using     oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing     exercise-induced hypoxemia in patients with COPD.   "
160647|NCT01180790|"     Evaluate safety, tolerability and antiviral response of ACH-0141625 compared to Standard of     Care in HCV positive subjects.   "
160648|NCT01180777|"     The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of     the printed etafilcon A with polyvinylpyrrolidone (PVP).   "
160649|NCT01180764|"     Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the good     cholesterol) work better.      Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and     other lipoproteins, in patients with high triglyceride levels.      Study funding: This study is being funded by an investigator-initiated research grant from     Glaxo Smith Kline.   "
160650|NCT01180751|"     This clinical trial is being conducted to study the use of a radioactive glucose tracer as an     imaging test [Positron Emission Tomography (PET)scan] in adults who have or are suspected of     having cancer and in another group of adults to assess for neurologic conditions.   "
160651|NCT01180738|"     The purpose of this study is to compare two different walking training programs for persons     with chronic stroke.   "
160652|NCT01180725|"     Background: Constipation is a common problem that affects nearly 60 million Americans. The     treatment of constipation remains challenging with one half of patients dissatisfied with     current therapy. There is a need for a food-based, natural, convenient and tasty alternative     to the currently available OTC laxatives and fiber supplements, particularly for patients     with occasional and mild constipation. Dried plums and prune juice have been traditionally     used for the treatment of constipation but has not been systematically assessed in patients     with well defined constipation. Also, the efficacy, palatability and tolerability of dried     plums in the treatment of chronic constipation have not been examined.      Aim: To investigate and compare the effects of dried plums and psyllium on the overall relief     of constipation symptoms, taste and quality of life in adults with functional constipation in     a randomized crossover controlled trial.      Methods: We propose to study 40 subjects with functional constipation in a single blinded,     randomized, cross-over study comparing 3 weeks of dried plums with 3 weeks of treatment with     Psyllium      Data analysis: The primary outcome measure will be the global relief of constipation symptoms     as rated by the subject at the end of each phase of the study. Additionally, we will assess     several secondary outcome measures that will include the number of Complete Spontaneous Bowel     Movements (CSBM) per week, Quality of Life , psychological profile, patient rating of taste     on a VAS scale, patient rating of bloating, distension, satiety and fullness and patient     rating of constipation-related symptoms.      Expected Results: We anticipate that treatment with dried plums will improve symptoms of     constipation compared to the baseline. This improvement will be comparable to that achieved     with psyllium (Metamucil) treatment. Additionally, dried plums will offer a natural, food     based, convenient and more tasty alternative to over-the-counter laxatives and fiber     supplements.   "
160674|NCT01180439|"     Non-invasive ventilation (NIV) in severe hypercapnic Chronic Obstructive Pulmonary Diseases     (COPD) may be associated - during sleep - with recurrent episodes of patient ventilatory     asynchrony, which in turn may affect quality of sleep, efficacy of ventilation and comfort of     nocturnal NIV.Polysomnography (PSG) under NIV is necessary to detect these events.      Adjusting ventilator settings according to respiratory events detected by PSG with NIV may     improve quality of sleep, efficacy of ventilation and comfort of nocturnal NIV.   "
160675|NCT01180426|"     The purpose of this study is to evaluate the long-term efficacy and safety profile of     tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.   "
160676|NCT01180413|"     The purpose of this study is to determine whether add-on of intensive vasodilator therapy can     improve the coronary perfusion and reduce the total peripheral resistance in patients with     ongoing treatment for essential hypertension.   "
160653|NCT01180712|"     Dietary strategies for alleviating the metabolic complications such as diabetes associated     with obesity are actively being pursued as alternatives to pharmaceutical interventions The     genus Vaccinium (e.g. blueberry, blaeberry, cranberry) has been used traditionally as a     source of folk remedies for established diabetic symptoms, primarily as leaf or stem     infusions or decoctions. Berries from this family such as blaeberry (BL) and blueberry (BB)     are enriched in anthocyanins, polyphenolics recognized for their ability to provide and     activate cellular antioxidant protection, inhibit inflammatory gene expression, and     consequently protect against oxidant-induced and inflammatory cell damage and cytotoxicity.     The association of obesity with adipose tissue stress, macrophage recruitment, and     inflammatory gene expression suggests that eating edible berries from this genus might     provide an effective alternative or supplementary intervention to attenuate obesity-     associated inflammation and the associated insulin resistance.      The aim of this study is to determine the effects of anthocyanin supplementation in the form     of a concentrated blaeberry extract on insulin resistance and inflammation particularly in     the adipose tissue following a three week supplementation period.   "
160702|NCT01180062|"     This study is a phase 1, open-label, dose-escalation, safety and tolerability study, which     will be conducted at one study site. This study will include 3 cohorts. Each cohort will have     approximately 5 subjects. Subjects will not be randomized into the study. The first cohort     will receive low dose drug insert, second cohort will receive 2 low dose drug inserts thus     achieving twice the drug levels compared to cohort I and third cohort will receive high dose     drug insert.   "
160703|NCT01180049|"     This study will compare the effectiveness and safety of two different doses of temsirolimus     (Torisel).   "
160654|NCT01180699|"     Influenza virus is an important cause of morbidity in the transplant population and can lead     to viral and bacterial pneumonia and contribute to the development of rejection. Although the     annual influenza vaccine is recommended for transplant patients, studies have shown that a     single intramuscular dose has poor immunogenicity. There are no studies that define the     effect of intradermal doses in this population. We plan to study the immunogenicity of two     different administration routes of the influenza vaccine in 200 solid organ transplant     patients during the 2010-2011 season. Patients will be randomized to receive influenza     vaccine either intradermally or intramuscularly. We hypothesize that the patients who receive     the intradermal influenza vaccine will significantly reach a higher response to the vaccine.     This study advances research on the prevention of serious viral infections in transplant     recipients. Results from this study have the potential to directly improve patient care. If     the use of the intradermal influenza vaccine is successful, this strategy may lead to a     significant reduction in burden of disease, hospitalizations, and long-term morbidity.   "
160655|NCT01180686|"     The purposes of this study are to determine if there is a difference between two treatment     methods of spine joints that are not moving as they should as determined by tenderness over     the spine and activity of the muscles along side the spine with movement.      The hypothesis is that there will be no difference between the two types of treatment.   "
160656|NCT01180673|"     This study will evaluate the effect of a senior center-based comprehensive therapeutic     lifestyle intervention delivered through group-based counseling and motivational interviewing     (MINT-TLC) among 250 hypertensive African American or Latino seniors age 60 and older in a     randomized control trial.   "
160657|NCT01180660|"     Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve     quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use of     intraoperative systemic lidocaine decrease postoperative opioid consumption and improve     quality of recovery after laparoscopic gastric bypass surgery.      This study has the potential to confirm an opioid sparing strategy for morbid obese patients     undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep apnea     and the increased risk of postoperative hypoxemia make the development of opioid sparing     techniques in this patient population warranted.   "
160658|NCT01180647|"     This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as     self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release     from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.   "
160659|NCT01180634|"     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which     has been particularly problematic to eradicate and been implicated as the major cause of     morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung     increases the local concentrations of antibiotic at the site of infection resulting in     improved antimicrobial effects compared to systemic administration. Decreased efficacy,     intolerance and high treatment burden with currently available therapies indicate a need for     additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone     levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies     conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an     antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal     antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active     against CF pathogens including those with high minimum inhibitory concentration (MIC) levels     to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled     MP-376 can be delivered rapidly and efficiently using a customized PARI investigational     configuration of the eFlow® nebulizer system.   "
160660|NCT01180621|"     The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1     pandemic of 2009. Many children either had the H1N1 infection or the adjuvanted H1N1 vaccine.     Both H1N1 infection and adjuvanted vaccine produced strong immune responses which could last     for some time.      The seasonal influenza vaccine for this fall will be a trivalent inactivated product (regular     seasonal influenza vaccine)once again, without adjuvant. It will contain 3 strains of killed,     split-apart viruses that might circulate this winter, including the H1N1 pandemic strain. It     is theoretically possible that giving the H1N1-containing seasonal vaccine to people who     still have some immunity to H1N1 virus could result in more frequent side-effects. However,     there is no good evidence that pre-existing immunity to a strain in the vaccine does increase     side-effects. In short, there could be nothing out of the ordinary this fall but it would be     prudent to check this before public flu vaccination programs begin.   "
160661|NCT01180608|"     Functional Imaging of the therapeutic effect of Pregabalin in treatment for neuropathic pain     in patients with Diabetic Polyneuropathy using proton Magnetic Resonance Spectroscopy (MRS):      The aim of our study is to investigate the effect of Pregabalin as a treatment for     neuropathic pain in a homogeneous study population, using proton MRS (1H MRS) focusing on     four regions of interest (bilateral thalami, rostral anterior cingulated cortex (rACC) and     dominant dorsolateral prefrontal cortex (DLPC).   "
160678|NCT01180387|"     The Reproductive Medicine Network (RMN) is a nationwide cooperative network of 7 clinical     sites and a data coordination center, and is sponsored in 5 year increments by The Eunice     Kennedy Shriver National Institute for Child Health and Human Development (NICHD). The RMN is     charged with designing, implementing and publishing high quality clinical research in     reproductive medicine. It has been in existence for over 15 years and has performed several     seminal clinical trials that have fundamentally changed clinical practice in this field. In     addition, many worthy ancillary protocols have been generated and published.      It is this latter fact, as well as the continued interest by investigators both inside and     outside the RMN for access to DNA or serum samples from the previously performed trials, that     has motivated the present investigators to proactively begin a biologic samples repository     from the ongoing and pending RMN clinical trials. Ideally, this repository would allow     investigators to seamlessly access trial samples for many years into the future, and thus     greatly amplify the use of resources and the impact of the RMN.   "
160679|NCT01180374|"     Cannabis is the most commonly used illicit substance in the US and herbal cannabis consists     of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the     interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD.   "
160662|NCT01180595|"     Total knee replacement is an effective option for treating chronic knee conditions that cause     pain and functional impairment. Significant improvements in quality of life, as measured by     both disease specific and generic quality of life measures have been well documented.     Carefully monitored introduction of new implant designs through small, randomized trials     using radiostereometric analysis (RSA) is gaining support. RSA is a radiographic technique     that uses small tantalum balls implanted into the patient's bone to measure micromotion (<1     mm) at the bone - implant interface, something which is not possible to do reliably using     regular x-ray techniques. The amount of micromotion that occurs within 2 years of surgery can     be used to predict the long term survival of knee replacements. This provides a method for     detecting inferior implant designs using only a small number of patients before release of     these products into large clinical trials.      The study purpose is to utilize RSA to compare the migration patterns of the Trabecular     Metal(TM) Monoblock and the TM Modular Total Knee Arthroplasties during the first two postop     years and to determine what proportion of cases achieve adequate fixation. Secondary outcome     measures will be recorded to quantify changes in functional status of subjects after surgery     and bone mineral density will be monitored to quantify any changes around the implant.     Migration patterns will be compared to results obtained from previous studies of uncemented     and cemented total knee arthroplasty components conducted at this centre.      Null Hypothesis: There is no significant difference in micromotion patterns of the TM     arthroplasty components of the monoblock design and the modular design.      Alternative Hypothesis: There are significant differences in micromotion patterns between the     tibial components of the monoblock design and the modular design.      This is a consecutive sample randomized control trial of patients undergoing total knee     arthroplasty with the TM Monoblock and TM Modular Knee Arthroplasty systems utilizing RSA to     identify the migration patterns of the tibial components of the implant. DEXA scanning will     also be conducted to determine changes in the bone mineral density adjacent to the implant.     Health status and functional outcome measures will be recorded to quantify functional status     of subjects before surgery and at each follow-up interval. Gait will be monitored and     analyzed preoperatively and postoperatively throughout the duration of the trial.   "
160663|NCT01180582|"     The purpose of this study is twofold: 1) to use RSA to determine the migration patterns of     the PA coated Triathlon Total Knee Arthroplasty components during the first 2 years     postoperatively and thus determine the proportion of cases where adequate fixation is     achieved, and 2) to use DEXA scanning to document peri-prosthetic bone mineral density     changes in response to the PA coated Triathlon Total Knee arthroplasty over the first two     postoperative years.      In addition, gait assessment and validated outcome questionnaires will be utilized to     quantify changes in functional status of subjects after surgery and migration patterns will     be compared to results obtained from previous studies of uncemented total knee arthroplasty     components conducted at this centre. Questions to be asked are: 1. Do the components achieve     adequate fixation to the underlying bone? 2. What are the migration patterns (translations     and rotations) of the PA coated arthroplasty components during the first two years     postoperatively and are they different from that seen for other implants that have been     studied with RSA at this institution? 3. For what proportion of implants does migration     continue to increase during the two year follow-up? 4. Are inducible displacements, measured     at weight-bearing follow-ups, consistent over time and do they indicate that adequate     fixation has been achieved? 5. Are there changes over time in bone mineral density of     peri-prosthetic bone in the PA coated Triathlon total knee arthroplasty? 6: Where do changes     in bone mineral density occur? 7: Is there a significant difference in health status and     functional outcome before and after total knee arthroplasty using PA coated Triathlon total     knee arthroplasty components? 8: Are there changes in gait symmetry and centre of mass (COM)     displacements as assessed with the Walkabout Portable Gait Monitor pre- and post-operatively     and how does study gait data compare to asymptomatic gait? and finally, Question 9: Are there     differences in the micromotion patterns between the when compared to other samples of knee     implants in our RSA database?   "
160664|NCT01180569|"     The purpose of this study is to see if a treatment with Lenalidomide, which is a pill given     by mouth for 7.5 months (30 weeks total), can delay the growth of lymphoma or shrink the     lymphoma. Lenalidomide is a pill that has been approved by the Food and Drug Administration     (FDA). It is used to treat some forms of cancer-like illnesses (myelodysplastic syndrome     (MDS)and in combination with dexamethasone for patients with multiple myeloma (MM) who have     received at least 1 prior therapy. MDS and MM are cancers of the blood). This drug works by     stimulating the body's immune system and by reducing the blood supply to cancer cells. Cancer     cells need blood to live and grow. In this study, the drug is considered a new or     experimental drug because we are learning how it works against your form of lymphoma.   "
160665|NCT01180556|"     The purpose of this study is to assess the effect of probiotics in childhood recurrent     abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4     weeks with a follow up phase of additional 4 weeks.   "
160666|NCT01180543|"     The purpose of this study was to demonstrate the effect of short treatment with active OPLON     patches on Acne.   "
160667|NCT01180530|"     This study is conducted in Asia, Europe and North America. The aim of this observational     study is to evaluate the safety of NovoPen Echo® by collecting safety information (incidence     of technical complaints related to adverse reactions). Study duration: 12-18 weeks.   "
160668|NCT01180517|"     The intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon     (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention     (PCI) of Medina 0,0,1 coronary bifurcation lesions. Patients will be randomized to treatment     with Plain Old Balloon Angioplasty (POBA)or treatment with DEB.   "
160669|NCT01180504|"     The primary objective of this phase-II study is to assess the toxicity of consolidation     intensity-modulated whole-abdominal radiotherapy using tomotherapy in patients with advanced     optimally debulked stage International Federation of Gynecology and Obstetrics (FIGO) III     ovarian cancer with a complete remission after adjuvant chemotherapy.      36 patients will be treated to a total dose of 30 Gy in 1.5 Gy fractions. The planning     target-volume includes the entire peritoneal cavity and the pelvic and para-aortal node     regions. Intensity-modulated whole-abdominal radiotherapy allows an effective sparing of     liver, kidneys and bone-marrow (vertebral bodies and pelvic bones).   "
160670|NCT01180491|"     The purpose of this study is to further evaluate and document early visible effects on nail     appearance of topical K101.   "
160671|NCT01180478|"     The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band     Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients     with non-muscle invasive bladder cancer.   "
160672|NCT01180465|"     LIPO-102 is under evaluation for treatment of abdominal adiposity   "
160673|NCT01180452|"     Patients with Crohn's disease (CD) have an increased risk of small bowel adenocarcinoma     (SBA). Long duration of CD is the main risk factor. SB dysplasia has been associated with SBA     in 20% of cases, always described in diseased sites. The progression to neoplasia and natural     history remains unknown but progression of inflammation to dysplasia and then to     adenocarcinoma is suspected.      As for surveillance recommendations for colorectal carcinoma in long standing inflammatory     colonic disease, endoscopic screening of SB could be proposed in CD patients with risk     factors of SBA. No study can be found in literature.      The investigators propose a multicenter exploratory open study on prospective cohort of CD     patients with high risk of dysplasia or cancer. The goal is evaluate the rate of dysplasia     and adenocarcinoma detected by enteroscopy with biopsies in a high risk CD population   "
160677|NCT01180400|"     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like     medicine tablet or capsule, but contains no active medicine) is safe and effective when taken     together with another antidepressant.   "
176036|NCT00144586|"     This is an open-label, extension, Phase III study to evaluate the long-term safety and     efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.   "
160680|NCT01180361|"     Hypothesis: SLE and RA increase risk of myocardial infarction (MI, heart attack). Immune     reactants in the circulation of SLE patients downregulate cholesterol efflux proteins     27-hydroxylase and ABCA1 and upregulate scavenger receptor CD36, thus encouraging cholesterol     accumulation. Adenosine A2A receptor agonist or statin treatment of cells exposed to SLE     plasma (or immune complexes or cytokine-enriched plasma fractions from SLE patients) may     ameliorate inflammatory properties of their plasma, lessening its atherogenic potency.      Rationale: SLE and RA plasma contain components not present in significant levels in normal     plasma that could, individually or acting together, affect 27-hydroxylase, ABCA1 and CD36     expression. Candidate components include autoantibodies, immune complexes, and various     cytokines. Statins reduce major cardiovascular events and death. Modulation of adenosine     signaling participates in regulation of 27-hydroxylase and ABCA1. As a potential preventative     and therapeutic approach to atherosclerotic cardiovascular disease, the investigators     evaluate the effect of A2A receptor agonists and statins on atherogenic parameters in SLE and     RA plasma.      Experimental Plan: Quantitate 27-hydroxylase and several other proteins involved in cellular     cholesterol uptake and excretion in THP-1 monocytes/macrophages and HAEC after exposure to     plasma and plasma components from SLE patients (and controls) ± lipid loading with acetylated     LDL with/without addition of A2AR agonist, statin, or both. Determine relative impact of     immune complexes and cytokines on expression of proteins involved in cholesterol flux.     Determine levels of proteins involved in cellular cholesterol influx/efflux in peripheral     blood mononuclear cells isolated from RA, SLE and psoriatic arthritis patients and normal     controls at baseline, then following incubation in culture media alone or with statin,     adenosine A2A agonist or both statin + A2AR agonist.   "
160681|NCT01180348|"     The dermatological treatment for reducing facial wrinkles with injectable drug Botulift     (botulinum toxin type A - Laboratório Químico Farmacêutico BergamoLtd.) has a not inferior     activity when compared with Botox ® (botulinum toxin - Allergan Inc.) in clinical trials.   "
160682|NCT01180335|"     This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven     chemotherapy in patients with breast cancer.   "
160683|NCT01180322|"     This is a randomized phase II, four-arm, open-label, multi-center study in adult patients     with acute myeloid leukemia (AML) as defined in inclusion/exclusion criteria.      The primary efficacy objective is to evaluate the impact of sequential or concurrent addition     of 5-azacytidine to intensive induction chemotherapy with idarubicin and etoposide on the     complete remission (CR) rate      Sample size: 336 patients      The treatment duration of an individual patient randomized into one of the three experimental     arms (Arm B, C, D) (in case of application of induction, consolidation and maintenance     therapy with Azacitidine) is about 30 months.      The treatment duration for patients randomized into the standard arm of the study (Arm A) is     about 7 months (in case of application of induction, consolidation and 2-yrs observation as     maintenance (without treatment with Azacitidine)).      In case of induction followed by consolidation with allogeneic Stem cell transplantation     (SCT) the treatment duration per patient is about 6 months.      Every patient will be followed until month 54 after inclusion into the study. Duration of the     study for an individual patient including treatment (induction, consolidation [chemotherapy     or allogeneic SCT], maintenance [experimental arm with Azacitidine or observation]) and     follow-up period: 54 months   "
160684|NCT01180309|"     Purpose To investigate the relationship between lingual frenum and possible alterations in     the articulation of phonemes.      Methods This is a quantitative observational study, the individual operative kind with     transversal time reference. The population sample consisted of 16 individuals, each one with     their phonological system complete. The data were captured through an application form that     contained relevant aspects as to the qualitative-classification of the lingual frenum,     quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue     mobility and ERT - 78 phonologically balanced words.   "
160685|NCT01180296|"     To evaluate whether daily oral micronized progesterone is effective in preventing recurrent     spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal     serum progesterone levels.   "
160686|NCT01180283|"     Sixty diabetes men with erectile dysfunction from mild to severe who agree to participate is     going to have medical care approximately for 16 weeks.      During the first 4 weeks, patients will not receive any inhibitor of phosphodiesterase 5. In     the following eight weeks, patients will receive oral lodenafil carbonate. They will complete     the International Index of Erectile Dysfunction (IIEF) questionnaire in the site and answer     the Sexual Encounter Profile (SEP) questions 2 and 3 and the Erection Hadness Score (EHS)     after each intercourse or attempt without or using oral lodenafil cardonate 80mg.      Questionnaire of adverse event is included in patient diary.   "
160687|NCT01180270|"     The purpose of this experimental pilot study is to test the effect of normalization of the     head position on the sense of balance at patients with cervical dystonia under routine     botulinum toxin treatment.   "
160688|NCT01180244|"     The purpose of this study is to determine whether persons treated with a low-intensity,     noninvasive form of cortical electrical stimulation experience a reduction in symptoms of     fibromyalgia different than persons receiving a sham treatment. Outcome measures include     reduction in patient pain levels and improvement in sleep measures.   "
160700|NCT01180088|"     The aim of this study was to evaluated the advantages of routine application of the anterior     approach in patients scheduled to right hepatectomy or extended right hepatectomy, without     infiltration of segment 1, inferior vena cava or main bile duct.   "
160889|NCT00000329|"     The purpose of this study is to assess the abuse liability and examine the reinforcing     effects of intravenous buprenorphine and buprenorphine/naloxone combinations in     buprenorphine-naloxone maintained volunteers   "
160701|NCT01180075|"     Purpose: To see how growing older changes the amount of HIV drugs in the blood of     HIV-infected men and women. Many changes happen in the body as it ages that may affect the     way drugs are carried in the blood, broken down or removed from the body. This study will     look at the amount of drug in the blood and cells of the immune system for patients taking     efavirenz, tenofovir and emtricitabine or atazanavir boosted with ritonavir, tenofovir and     emtricitabine.      Participants: The population will comprise of 56 (6 for intensive PK and 50 for sparse     sampling) HIV-infected adults currently adhering to an antiretroviral regimen containing     efavirenz with tenofovir and emtricitabine and the same number and distribution of     HIV-infected adults currently adhering to an antiretroviral regimen containing atazanavir     boosted with ritonavir with tenofovir and emtricitabine.      Procedures (methods): This study will be completed at the University of North Carolina at     Chapel Hill. There will be four groups of subjects: Efavirenz/tenofovir/emtricitabine Group     A, Efavirenz/tenofovir/emtricitabine Group B, Atazanavir/ritonavir/tenofovir/emtricitabine     Group A, and Atazanavir/ritonavir/tenofovir/emtricitabine Group B.      The initial six subjects (Group A) for intensive PK analysis for each regimen will be     recruited from the the UNC ID Clinic or the Moses Cone Health System Infectious Diseases     Clinic, and will be comprised of non-frail subjects not currently receiving interacting     drugs. If subjects provide informed consent, timed blood samples will be obtained to     determine pharmacokinetic parameters around an observed dose of one of the two study     regimens. A whole blood sample will also be collected and stored for potential drug     metabolizing enzymes and transporters genotyping in the future. Group A subjects will     complete a follow-up visit after their sampling visit.      50 subsequent subjects (Group B) for each regimen will be screened simultaneously, with no     more than 10 subjects enrolled for each regimen in Group B prior to the completion and     analysis of Group A. These subjects will also be recruited from either site. Group B subjects     will have one or two sampling visits with 1 to 4 blood samples obtained at each visit, with a     stored sample for future genotyping obtained on one of the visits. Samples will be collected     just prior to a dose, at 2 hours, between 4 and 6 hrs, and between 10 and 14 hours after a     medication dose. These visits may coincide with the subjects' regularly scheduled visit to     the clinic, or be scheduled separately, depending on the preference and availability of the     subject.   "
160689|NCT01180231|"     The prevalence of obesity is increasing rapidly among adults and has more than doubled in the     past 10 years. The metabolic syndrome (MS) is often associated with obesity. It is     characterized by abdominal obesity, high blood pressure, unfavorable blood cholesterol     profile, elevated blood sugar and impaired insulin action. Persons with the MS have an     increased risk of developing type 2 diabetes as well as heart and kidney disease.      The prevalence of obesity and MS is also very high in children and young adults. While there     are increasing numbers of studies assessing risk factors for cardiovascular and kidney     disease in middle aged to older obese subjects, few studies have addressed the issue of the     presence of obesity in young adults and its association with MS on early damage to the organs     such as the kidneys, the heart and the blood vessels. The investigators' laboratory has a     particular interest on the sympathetic nervous system, which is an important regulatory     mechanism of both metabolic and cardiovascular function, as altered sympathetic activity may     play a role in the complications of obesity.      Moxonidine is a medication that is approved in Australia by the Therapeutic Goods     Administration to treat high blood pressure. It works by decreasing the activity of the     sympathetic nervous system. With the elevation of the sympathetic activity in obesity, the     investigators believe moxonidine may have a favourable role in rescuing early organ damage     associated with obesity. This study will assess whether treating obese subjects with     moxonidine have positive effects on blood vessels, cardiac and kidney function and anxiety     disorder. The investigators will also examine the influence of the sympathetic nervous system     activity in these possible altered cardiac, kidney and vessel functions.   "
160690|NCT01180218|"     To investigate the clinical outcomes of acute myocardial infarction (AMI) patients with     multivessel disease undergoing percutaneous coronary intervention (PCI) either in     infarct-related artery only or in multivessel in Drug eluting stents (DES) era, using the     everolimus-eluting stent (Promus™ Element™ Stent, Boston Scientific) in real-world clinical     practice.   "
160691|NCT01180205|"     To show superior effects of the combination Telmisartan and Amlodipine (T and A) vs     Olmesartan and Hydrochlorothiazide (O and HCTZ) on endothelial dysfunction as measured by     flow mediated dilation (FMD) in hypertensive at risk patients beyond bloodpressure BP (equal     BP in both arms; target BP <140/90 mmHg (<130/80 mmHg for renally impaired and/ or diabetic     patients). To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness     and carotid atherosclerotic plaques.   "
160692|NCT01180192|"     In the aetiology of postpartum uterine atony, hypoxia is considered an important factor     although some suggest that peripheral oxygen saturation is not influenced by oxygen     inhalation in women during the first and second stages of labor. Enhancing oxygen delivery to     myometrium through additional inhaled oxygen may improve uterine contractions. Therefore, it     is reasonable to consider that oxygen inhalation may promote myometrial contraction and     prevent postpartum haemorrhage (PPH) due to uterine atony. The tendency for the uterus to     relax in women encountering respiratory problems immediately after cesarean section under     general anaesthesia further strengthened this theory.      The aim of this study was to evaluate the effectiveness of oxygen inhalation immediately     after vaginal delivery on blood loss. The investigators hypothesized that inhaled oxygen     helps to maintain uterine retraction during immediate postpartum period and hence reduces     vaginal blood loss.   "
160693|NCT01180179|"     The aim of this study is to compare the efficacy of a proton pump inhibitor (lansoprazole)     and a histamine-2 receptor antagonist (famotidine) in preventing recurrent ulcer bleeding in     patients with a history of H. pylori-negative idiopathic peptic ulcers.   "
160694|NCT01180166|"     The prognosis of patients with inoperable locally advanced or residual/relapsed gastric     cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended.     Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown     its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of     these treatment need to be further analyzed.   "
160695|NCT01180153|"     To evaluate efficacy and safety of S-1 Oxaliplatin (SOX) regimen to patients with     unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma.   "
160696|NCT01180140|"     The purpose of this study is to determinate the utility of staple-line reinforcement on     lineal gastrointestinal anastomoses.      Hypothesis: Seamguard device will decrease the incidence of leak and bleeding in digestive     lineal stapled anastomoses.   "
160697|NCT01180127|"     This is a randomized controlled trial to test the impact of a flavonol containing food     product and aerobic exercise on cognitive function and brain structure.   "
160698|NCT01180114|"     The overall goal of SUUBI-MAKA is to further develop and preliminarily examine a family     economic empowerment intervention that creates economic opportunities (specifically Children     Development Accounts) for families in Uganda who are caring for children orphaned due to the     AIDS pandemic, and to lay groundwork for a bigger study with practice and policy implications     for Sub-Saharan Africa.   "
160699|NCT01180101|"     Obesity is an established risk factor for development and progression of kidney disease.     Intentional weight loss in people without kidney disease results in an improvement in     diabetes, blood pressure, cholesterol, cardiovascular disease and overall death rates. The     investigators do not know whether this holds true in patients with chronic kidney disease. In     the proposed pilot study, the investigators will analyze if kidney function stabilizes after     weight loss interventions in obese kidney disease patients and the mechanisms that might     mediate this beneficial effect. If weight loss in kidney disease patients results in     stabilization of kidney function, this would provide an opportunity to conduct a long-term     prospective study to analyze the sustained benefits of weight loss in kidney disease     patients.      Specific aim 1:      To ascertain the effects of lifestyle modification or bariatric surgery on urinary protein     excretion and renal function among obese CKD patients.      Hypothesis: Weight loss attained through either lifestyle modification or surgical     intervention will result in lowering of urinary protein excretion and stabilization of renal     function among obese CKD patients.      Specific aim 2:      To identify the mechanism that mediates the change in urinary protein excretion and renal     function among obese CKD patients undergoing lifestyle modification or bariatric surgery.      Hypothesis: Weight loss attained through either lifestyle modification or surgical     intervention will result in amelioration of endothelial dysfunction, inflammation, insulin     resistance and an increase in High Molecular Weight (HMW) adiponectin levels that then     mediate the improvement in urinary protein excretion and renal function among obese CKD     patients.   "
160705|NCT01180023|"     Sweeping or stripping of the membranes (in this paper referred to as membrane sweeping) is     a widely utilized technique to hasten delivery for women at 37+ weeks gestation. The process     of membrane sweeping probably causes release of prostaglandins from the decidua and the     cervix. The efficacy of membrane sweeping is well studied, and has been shown to increase the     number of patients in labor within 72 hours, reduce the frequency of pregnancy continuing     beyond 41 or 42 weeks, and reduce the frequency of formal induction of labor. Thus, it is a     safe and practical option for women who wish to avoid inductions of labor or postterm     pregnancies.      Group B streptococcus (GBS; streptococcus agalactiae) is a gram positive coccus that     frequently colonizes the human genital tract. In pregnant women, GBS can cause urinary tract     infections, chorioamnionitis, and postpartum endometritis. Newborn infants can also acquire     GBS infection during passage through the vagina. Early onset GBS disease in the newborn can     lead to pneumonia, meningitis, and sepsis, all of which can be life-threatening. Early onset     GBS disease has become rare since the widespread use of GBS screening and prophylactic     treatment of pregnant women.      The relationship between early onset GBS disease and sweeping of the membranes is not known.     Based on the theoretical increased risk of bacterial seeding after membrane sweeping, as well     as concern for fast labors and inadequate treatment after membrane sweeping, some     practitioners choose not to sweep membranes in GBS positive patients. A meta-analysis did not     show a difference in neonatal or maternal infection rates between women who underwent     membrane sweeping and those who did not. ACOG guidelines state the risks of membrane     stripping in GBS positive patients has not been investigated in well-designed, prospective     studies. Therefore, data are insufficient to encourage or discourage this practice.      Specific Aims:      In order to help elucidate the effect of membrane sweeping in GBS positive patients, the     investigators propose this prospective randomized trial. The investigators primary objective     is to determine whether membrane sweeping in GBS positive women is associated with inadequate     antibiotic treatment in labor (defined as less than four hours of antibiotic therapy prior to     delivery). The investigators secondary objectives are to measure the effect of membrane     sweeping on pregnancy duration, length of labor and adverse events potentially related to     membrane sweeping such as maternal chorioamnionitis and neonatal morbidity. Randomization is     the real research portion of this study, since offering membrane sweeping is already the     standard of care. Patients are followed until the time of delivery, which is within 6 weeks     of enrollment for most women.   "
160706|NCT01180010|"     This research study is being done because patients with a history of chest radiation     treatment for Hodgkin's disease have been shown to be at increased risk for developing lung     cancer a number of years out from treatment. The risk appears to be further increased among     patients with a smoking history. In this study, the CT scans will be read and interpreted by     the study radiologist, and the results recorded in a consistent manner. Depending on the     findings of the initial CT scan, we will then either repeat the scan in 1 year, or if     indicated, send you for further scans or a biopsy. The information collected in this study     will help researchers and clinicians in providing more concrete recommendations and screening     guidelines for future survivors of Hodgkin's disease who have had similar exposures to     radiation and/or chemotherapy and smoking.   "
160707|NCT01179997|"     The aim of this study was to compare the response to cardiac resynchronization therapy when     the interventricular pacing interval was optimized by Tissue Doppler Imaging (TDI) to     response when it was optimized following QRS width criteria.   "
160708|NCT01179984|"     The purpose of this study is to evaluate the effectiveness and safety of a new delivery     system for the Bard® LifeStent® Vascular Stent System.   "
160709|NCT01179971|"     Purpose: To investigate into the differential effects of polyunsaturated fatty acids as     compared to standard control therapy (olive oil) on disease activity and biochemical     parameters in patients with rheumatoid arthritis (RA), resp. psoriasis arthritis (PA).   "
160710|NCT01179958|"     The purpose of this study is to test the hypothesis that aerobic exercise leads improved     cognitive function accompanied by increases in gray matter density and changes in functional     magnetic resonance imaging (fMRI) patterns of task-related activation.   "
160711|NCT01179945|"     The investigators propose to examine the effects of the common food preservative sodium     benzoate on blood glucose and related hormones and metabolites. If an effect is demonstrated,     patients with increased diabetes risk could be counseled to avoid this preservative.   "
160712|NCT01179932|"     Primary Objective: Conduct a prospective, observational pilot study that assesses the     frequency and severity of anesthesia charting fidelity weaknesses in three separate clinical     environments (Cardiac surgical operating room, cardiac surgical intensive care unit, and     electrophysiology laboratory) as assessed by a customized error scoring system that focuses     on the magnitude of errors among multiple continuous, categorical and dichotomous variables.     The errors are being assessed in order to identify the most common charting inaccuracies so     that target areas appropriate for testing of improvement strategies may be isolated.   "
160713|NCT01179919|"     One in three Americans are obese. Obese subjects may or may not need higher doses of the     anti-flu drug known as Tamiflu (oseltamivir). The current study is being done to see if the     FDA approved dose of oseltamivir will achieve similar concentrations in obese healthy     volunteers compared to that previously shown in non-obese volunteers.   "
160714|NCT01179906|"     Aerobic training has been shown to favorably alter several of the known risk factors for     coronary artery disease including hypertension, dyslipidemia, obesity, and diabetes (1). It     seems logical that if these risk factors were aggressively controlled in patients with     chronic kidney disease (CKD) by implementing lifestyle changes (e.g., diet and exercise     training) to support the pharmacologic interventions that are necessary for the control of     the disease, then the rate of progression of the disease may be altered. However, to date,     there is no clear research evidence to support this hypothesis. Therefore the aims of the     proposed study are:        1. To test the hypothesis that lifestyle interventions (i.e., dietary modification and          regular, long-term aerobic exercise training) will favorably alter the natural          progression of CKD in a sample of patients compared to a control group who will receive          the current standard care.        2. To explore possible mechanisms that could contribute to the observed changes.   "
160715|NCT01179893|"     Immunomodulation is effective in treating patients with myasthenia gravis (MG), but prior     studies have not adequately defined if plasma exchange (PLEX) in superior to intravenous     immunoglobulin (IVIG) in the treatment of myasthenia gravis. This study aimed to determine if     PLEX was superior to IVIG in the treatment of patients with myasthenia gravis.      Patients with MG requiring immunomodulation are randomized to IVIG or PLEX and treated with a     full course of immunomodulation. The quantitative myasthenia gravis score (QMGS) will be     evaluated as the primary efficacy parameter at day 14 to determine if PLEX is superior to     IVIG.   "
160716|NCT01179880|"     The safety and pharmacokinetics of topical application with E6005 ointment compared to     vehicle will be evaluated in Japanese male patients with atopic dermatitis. Additionally, the     efficacy of topical application with E6005 ointment will be explored in Japanese male     patients with atopic dermatitis.   "
160850|NCT00000290|"     The purpose of this study is to determine the HPA axis and adrenergic system activation in     response to cocaine administration.   "
160717|NCT01179867|"     The purpose of this study is to determine if a physician's use of electronic medication     reconciliation software when writing a patient's discharge prescription will prevent adverse     drug events and readmissions to the hospital. This electronic medication software will     provide the physician with the most up-to-date list of medications the patient was taking     before being admitted to the hospital, through a real-time link to the provincial drug     insurance agency's administrative databases. It will also provide the list of medications the     patient has taken while admitted to the hospital. With these two pieces of information, the     physician will write the discharge prescription using the medication management software,     print the discharge prescription for the patient, and the software will fax a copy of any     prescriptions that should be stopped to the patient's community pharmacist.   "
160718|NCT01179854|"     The purpose of this study is to determine weather different doses of Remegal are     effective,safety and tolerant in Additional Therapy for Patients With Refractory Partial     Seizures and pharmacokinetics definition   "
160719|NCT01179841|"     This research is being done to test the effectiveness of an early intervention model for very     young children at high risk for autism spectrum disorders (ASD) and their families. If     children show improvement in this intervention, the investigators hope that the availability     of public services of this type will be increased. Children between 11 months and 21 months     old with Autism Spectrum Disorders, or with social and communication delays that indicate     high risk for Autism Spectrum Disorders, and their parents may join the study. Treatment must     start prior to the second birthday.   "
160720|NCT01179828|"     Drug therapy in patients with chronic low back pain is a major challenge for physicians. One     of the problems is the lacking knowledge in prediction of drug efficacy in a chosen patient.     Usually one of the classes of pain medication is given to patients with a similar clinical     picture, although different pain mechanisms may be responsible for this clinical picture.      Another reason for variable drug efficacy are genetic polymorphisms, this may be the reason     why an unique drug produces different responses (from a lacking analgesic effect up to     excessive effect or side-effects.      Quantitative sensory testing is a method that documents alterations in the pain perception     system. Linking genetic polymorphisms to quantitative sensory testing may give us a tool for     anticipation of drug efficacy.   "
160721|NCT01179815|"     Currently, the estimated number of people with diabetes mellitus is approximately 387 million     people worldwide. Due to population growth, urbanization, ageing and the rising prevalence of     obesity the numbers of individuals with diabetes is increasing likewise. It has been shown     that improving glycemic control is associated with a reduction in late complications of     diabetes, such as cardiovascular and microvascular diseases. Therefore, treatment guidelines     were established internationally by large and renowned associations and adopted by many     countries.      For Switzerland only sparse data exist on the actual implementation of such recommendations     and on patient's well-being. The Swiss Diabetes Registry - SwissDiab Study is a prospective     cohort study aiming at including and collecting data of virtually all patients regularly seen     and treated at the study centers (≈ 500 patients each), irrespective of type, duration of     diabetes or treatment . This allows the evaluation of diabetes treatment strategies at these     centers. Furthermore, risk indicators for micro- and macrovascular complications, mortality     as well as costs and quality of life will be assessed. Data will be recorded through an     internet-based, electronic database specifically designed for this study. At a later     perspective it is planned to extend data collection to general practitioner/family doctor     networks in order to include a larger and more representative sample of patients with     diabetes in Switzerland.   "
160722|NCT01179802|"     Until now it has been assumed that regular endurance training has a positive influence on     cardiac function and that the positive effect increases with increasing intensity. However,     little is known about the effects of intense endurance stress on the heart. According to     current knowledge repeated exposure to strenuous endurance activity may lead to minor but     possibly irreversible damage to the heart with resultant scarring of the heart's muscle.      Within this study we attempt to find out by different analytical methods - in particular     magnetic resonance imaging (MRI) and ultrasound of the heart - to what extent the heart     muscle is affected by an intense endurance exercise, i.e. the Jungfrau-Marathon, and which     changes can possibly be found. Due to repeated measurements we will obtain further     information on the short-term course of possible changes.      Hypotheses: A single bout of prolonged strenuous exercise (PSE) leads to transient alteration     in cardiac function accompanied by the appearance of biomarkers for myocardial damage.   "
160723|NCT01179789|"     Ageing of the population is a major event in the world. Gerontological/geriatric literature     unanimously indicate that physical exercise and diet are at present the two available     fundamental approaches to contrast/prevent most of the age associated alterations. In the     elderly the inflammageing, the oxidative stress and the alteration of the intestinal     microbiota can be influenced by nutritional status and possibly corrected by an appropriate     dietetic intervention:      Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve     the quality of individual diet for specific needs   "
160724|NCT01179776|"     Acute myocardial infarct patients with STEMI (ST-elevation on ECG) whom undergo a primary     percutaneous cardiac intervention will following the standard treatment , received low dose     of Ilomedin and to low dose of standard treatment for another 24 hours.   "
160725|NCT01179763|"     The purpose of this study is to examine retinal layer thickness in amblyopia.   "
160734|NCT00000108|"     The purpose of this research is to find out whether training at different exercise     intensities reduces the risk of developing cardiovascular disease (CVD) to a different     extent. Heart attacks and stroke are the leading cause of death in older women. Reduced     variability of the heart rate and increased dips and swings in blood pressure are risks     factors that predict the chance of developing CVD as are increased levels of clotting protein     fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol     (>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat     level before you start training and after 15 and 30 weeks of training in the form of walking.     At the present time the effects of exercise intensity on these factors are not well     understood. This study will add to the basic understanding of these issues and allow us to     recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce     the risk of developing CVD.   "
160726|NCT01179750|"     Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once     during operation. It was proved that a laparoscopic gastric resection showed significantly     shorter operative time and less work load distribution, and more stability of bleeding than     before an introduction of ultrasonic coagulating shears .      In an open gastric cancer surgery, ultrasonic coagulating shears have been often used for     lymph node dissection or cutting of small vessels in some hospitals in Korea. However its     usefulness or effectiveness has not been fully proved. There was only one report about using     ultrasonic coagulating shears in open gastrectomy. The report contained small number of     subjects and surgical procedures were different from the investigators.      The investigators expect to reduce operative time and blood loss with ultrasonic coagulating     shears. Ultrasonic coagulating shears will also enable us to dissect lymph node with closure     of lymphatics. This may reduce the amount of drainage fluid from peritoneal cavity and     shorten the removal time of a drain, which will also shorten the hospital stay.      The objective of this study is to evaluate the safety and benefit of ultrasonic coagulating     shears in open gastrectomy including usefulness and effectiveness by a randomized controlled,     prospective study.   "
160727|NCT01179737|"     The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in     this population and to test the hypothesis that 6 months treatment with nilotinib will     significantly reduce pulmonary artery resistance.   "
160728|NCT01179724|"     after endoscopic submucosal dissection(ESD) of early gastric cancer, conventional proton     pump(PPI) inhibitors and H2 receptor antagonists have a controversial effect on preventing     bleeding from artificial ulcers. the aim of this study was to investigate whether a stronger     acid suppression (high dose PPI) more effectively prevents bleeding after ESD   "
160729|NCT00000102|"     This study will test the ability of extended release nifedipine (Procardia XL), a blood     pressure medication, to permit a decrease in the dose of glucocorticoid medication children     take to treat congenital adrenal hyperplasia (CAH).   "
160730|NCT00000104|"     Inner city children are at an increased risk for lead overburden. This in turn affects     cognitive functioning. However, the underlying neuropsychological effects of lead overburden     and its age-specific effects have not been well delineated. This study is part of a larger     study on the effects of lead overburden on the development of attention and memory. The     larger study is using a multi-model approach to study the effects of lead overburden on these     effects including the event-related potential (ERP), electrophysiologic measures of attention     and memory are studied. Every eight months, for a total of three sessions the subjects will     complete ERP measures of attention and memory which require them to watch various computer     images while wearing scalp electrodes recording from 11 sites. It is this test that we are     going to be doing on CRC. There will be 30 lead overburdened children recruited from the     larger study for participation in the ERP studies on CRC. These 30 children will be matched     with 30 children without lead overburden. This portion of the study is important in providing     an index of physiological functioning to be used along with behaviorally based measures of     attention and memory, and for providing information about the different measures.   "
160731|NCT00000105|"     The purpose of this study is to learn how the immune system works in response to vaccines. We     will give the vaccines to subjects who have cancer but have not had treatment, and to     patients who have had chemotherapy or stem cell transplant. Some patients will get vaccines     while they are on treatments which boost the immune system (like the immune stimulating drug     interleukin-2 or IL-2). Although we have safely treated many patients with immune boosting     drugs, we do not yet know if they improve the body's immune system to respond better to a     vaccine. Some healthy volunteers will also be given the vaccines in order to serve as control     subjects to get a good measure of the normal immune response. We will compare the patients     and the healthy volunteers to study how their immune systems respond to the vaccines.      There are several different types of white cells in the blood. We are interested in immune     cells in the blood called T-cells. These T-cells detect foreign substances in the body (like     viruses and cancer cells). We are trying to learn more about how the body fights these     foreign substances. Our goal is to develop cancer vaccines which would teach T-cells to     detect and kill cancer cells better. We know that in healthy people the immune system     effectively protects against recurrent virus infection. For example, that is why people only     get mono (mononucleosis) once under normal circumstances. When the body is infected with     the mono virus, the immune system remembers and prevents further infection. We are trying     to use the immune system to prevent cancer relapse. To test this, we will give two vaccines     which have been used to measure these immune responses. Blood samples will be studied from     cancer patients and will be compared to similar samples from normal subjects.   "
160732|NCT00000106|"     Recently a non-toxic system for whole body hyperthermia (WBH) used at the University of     Wisconsin has been shown to induce soluble tumor necrosis factor-receptor (sTNF-R) I and II     when patients are heated systemically to 41.8C for 60 minutes. This observation might provide     a biological basis for the therapeutic application of WBH to rheumatoid diseases, for which     there is a positive anecdotal clinical experience. Inherent in the hypothesis which is the     basis for this protocol is the concept that the induction of TNF receptors by WBH may induce     a remission in patients with active rheumatoid arthritis. Beyond clinical response the     biological endpoint for this investigation includes cytokine levels, TNF levels, sTNF-R     levels and changes in cellular TNF receptors.   "
160733|NCT00000107|"     Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial     natruretic peptide (proANP) which most likely results in chronic dehydration, leading to     reduced oxygen transport to tissues and shortness of breath with activity. The purpose of     this study is to characterize adults with cyanotic congenital heart defects with respect to     their body composition (water and fat-free mass) and resting metabolic rates. The study     consists of several measures of how much body water, fat and lean tissue a subject has, and     measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic     congenital heart disease will be recruited along with healthy noncyanotic control subjects     matched for age, gender, and body weight.   "
160772|NCT00000209|"     The purpose of this study is to explore the feasibility of extending the dosing interval of     well maintained buprenorphine patients to 48 and 72 hours, leading to eventual 3 times/week     dosing.   "
160773|NCT00000210|"     The purpose of this study is to assess the safety and effectiveness of buprenorphine for     treatment of concurrent intravenous heroin and cocaine dependence.   "
160735|NCT00000110|"     The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS)     to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged     bout of endurance running and, 2) determine the pattern (time course) of IML replenishment     following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of     energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour     training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat     diet in 10 endurance trained athletes who will consume both diets in a randomly assigned     cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance     exercise, and that replenishment of IML will be impaired by an extremely low-fat diet     compared to a moderate-fat diet. Results of this pilot study will be used to apply for     extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary     fat on the health and performance of individuals performing heavy physical training. It is     anticipated that this methodology could also be employed in obesity research to delineate,     longitudinally, the reported cross-sectional relationships among IML stores, insulin     resistance and obesity.   "
160736|NCT00000111|"     The purpose of this study is to see if we can develop a good graft for oral mucosal tissue     that is like the top of the mouth in a test tube that could be used successfully in humans.     We have already done this successfully mice. The next step is to take a small piece of tissue     from a human volunteer and see if we can grow a larger piece of tissue from it outside the     human body and graft it back into the same person successfully. We expect that this technique     will work. It has already been tried in patients with burns of the skin who have had similar     procedures where the skin is grafted back to them. The significance of this research is that     oral tissue taken from the top of the mouth or palate is in limited supply and leaves the     patient with a painful and uncomfortable post surgery experience. If we are successful with     our technique the patient will experience less pain and discomfort from the site that we are     using to grow our tissue outside the body than if we had taken it from the top of the mouth     or palate. In addition, by waiting longer periods to grow the patient's cells we can make     larger pieces of oral tissue than we could have gotten directly from the patient's mouth.     Patients who will participate in this study will need to require a soft tissue graft from the     mouth to an area that needs additional attached or keratinized mucosa. This will most likely     be either in preparation for patients who have or will have dental implants placed. Another     subset of patients are those who need scar tissue released or the vestibule of their mouth     (area that turns from the gums to the lip) released.   "
160737|NCT00000112|"     The prevalence of obesity in children is reaching epidemic proportions. Excess adiposity is     more than just a cosmetic problem, having substantial metabolic consequences. Insulin     resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen     in obese children. In this study the prevalence of impaired glucose (carbohydrate) tolerance     in lean children with a family history of diabetes and obese children with acanthosis     nigricans with or without a family history of diabetes mellitus will be studied.   "
160738|NCT00000113|"     To evaluate whether progressive addition lenses (PALs) slow the rate of progression of     juvenile-onset myopia (nearsightedness) when compared with single vision lenses, as measured     by cycloplegic autorefraction. An additional outcome measure is axial length, as measured by     A-scan ultrasonography.      To describe the natural history of juvenile-onset myopia in a group of children receiving     conventional treatment (single vision lenses).   "
160739|NCT00000114|"     To determine whether supplements of vitamin A or vitamin E alone or in combination affect the     course of retinitis pigmentosa.   "
160740|NCT00000171|"     This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated     with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of     AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for     caregivers. Alternatives are sorely needed to the currently available sleep medications that     have marginal efficacy and serious side effects. Melatonin is a naturally occurring hormone     secreted by the pineal gland. It has soporific effects with oral administration and is well     tolerated. It enhances sleep in normal older people. Melatonin also may help sleep     disturbances associated with AD; however, this remains to be proven.   "
160755|NCT00000192|"     The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated     opiate withdrawal.   "
160756|NCT00000193|"     The purpose of this study is to evaluate the effects of gamma hydroxybutyric on     naloxone-precipitated opiate withdrawal.   "
160757|NCT00000194|"     The purpose of this study is to study the effects of cycloserine on naloxone-precipitated     opiate withdrawal.   "
160758|NCT00000195|"     The purpose of this study is to determine the effect of chronic naltrexone pre-treatment on     the response to yohimbine in healthy volunteers.   "
160741|NCT00000172|"     Galantamine is an experimental drug being evaluated in the United States for the treatment of     Alzheimer's disease. Results from previous clinical trials suggest that galantamine may     improve cognitive performance in individuals with Alzheimer's disease. It is not a cure for     Alzheimer's disease. Nerve cells in the brain responsible for memory and cognitive function     communicate using a chemical called acetylcholine. Research has shown that deterioration of     cells that produce acetylcholine in the brain affects thought processes. Galantamine is     thought to work in two ways to increase the amount of acetylcholine available in the brain.     It inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic     receptors in the brain to release more acetylcholine.   "
160774|NCT00000211|"     The purpose of this study is to assess the safety and effectiveness of buprenorphine for     treatment of concurrent intravenous heroin and cocaine dependence.   "
160775|NCT00000212|"     The purpose of this study is to evaluate the effects of desipramine DMI maintenance on     cocaine taking and on the physiological and subjective effects of cocaine, including cocaine     craving.   "
160776|NCT00000213|"     The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine     taking and on the physiological and subjective effects of cocaine, including cocaine craving.   "
160777|NCT00000214|"     The purpose of this study is to evaluate the effects of buprenorpine on cocaine taking and on     the physiological and subjective effects of cocaine, including cocaine craving in non-opiate     dependent cocaine users.   "
160742|NCT00000173|"     The National Institute on Aging (NIA) is launching a nationwide treatment study targeting     individuals with mild cognitive impairment (MCI), a condition characterized by a memory     deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from     both dementia and normal age-related changes in memory. Accurate and early evaluation and     treatment of MCI individuals might prevent further cognitive decline, including development     of Alzheimer's disease (AD).      The Memory Impairment Study is the first such AD prevention clinical trial carried out by     NIH, and will be conducted at 65-80 medical research institutions located in the United     States and Canada. This study will test the usefulness of two drugs to slow or stop the     conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an     investigational agent approved by the Food and Drug Administration for another use. Vitamin E     (alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997 study     to delay important dementia milestones, such as patients' institutionalization or progression     to severe dementia, by about seven months.   "
160743|NCT00000174|"     This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled,     36-month study comparing the length of time of progression from mild cognitive impairment     (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs.     placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a     treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40     countries for Alzheimer's disease to date, including all 15 member states of the European     Union, New Zealand, Argentina, Brazil and Mexico.      Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo.     Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day)     for the majority of the study. At every regular visit scheduled every three months, patients     will be given basic efficacy and safety assessments. These assessments will include     evaluation of adverse events, vital signs, activities of daily living, and clinical staging     scales to determine if the subject may have converted to dementia.   "
160744|NCT00000175|"     This study is investigating the effects of hormone replacement therapy on memory, mental     abilities and mood in older adults aged 65-90. During the nine month long study, men will     take testosterone for three months and women will take estrogen for three months. At four     points during the study (once every three months), participants will complete a test battery     and have blood drawn.   "
160745|NCT00000176|"     This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's     disease in women with a family history of Alzheimer's disease.   "
160746|NCT00000177|"     Estrogen is a hormone that is dominant in the female reproductive system. In women, most     estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into     estrogen. Because this hormone also has many beneficial effects on brain cells, it currently     is being studied as a treatment for Alzheimer's disease. The enzyme that forms the     neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small     clinical studies have demonstrated improvement in cognitive function and mood measures in     women with Alzheimer's disease who take estrogen.   "
160747|NCT00000178|"     This is a randomized placebo controlled, double blind study. Patients who meet eligibility     criteria and decide to participate in the study will be randomly assigned to receive either     drug treatment or a placebo. Neither the patients nor the participating investigators will     know who is receiving the drugs and who is receiving the placebo. Participation involves 15     outpatient clinic visits over a 68 week period. Patients take study medication at varying     doses (the maximum dose is 20 mg daily), along with calcium and vitamin supplements.   "
160748|NCT00000179|"     Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and     physical aggressiveness, irritability, wandering, and restlessness. These behaviors often     make caring for patients at home very difficult. Trazodone and haldol are two of the most     commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug     approach, has been effective in reducing signs of agitation. Researchers have yet to compare     the effectiveness of drug versus non drug therapy to treat agitation in AD patients and     determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with     funding from the National Institute on Aging, is conducting an agitation treatment program at     21 sites in 16 States. This study will assess which of the above treatments is most     effective.   "
160749|NCT00000180|"     AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve     function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting     in the brain. Preclinical studies in animals have shown that AIT-082 improves memory in aged     animals and in animals with neurological deficits.      This study was a double-blind placebo-controlled safety study that was designed to study     whether AIT-082 may delay age-related mental decline. Eight healthy older volunteers at two     clinical sites were given single, weekly, rising doses of AIT-082 or placebo for 5 weeks;     were tested for side effects and absorption; and underwent a battery of neuropsychological     memory tests, including word and number recall tests.   "
160750|NCT00000187|"     The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine     dependence.   "
160751|NCT00000188|"     The purpose of this study is to assess selegiline as a pharmacotherapy for cocaine     dependence.   "
160752|NCT00000189|"     The purpose of this study is to test antidepressant medication, gepirone, as a     pharmacotherapy for cocaine dependent subjects.   "
160753|NCT00000190|"     The purpose of this study is to establish the use of parotid saliva as a means of detecting     and quantifying cocaine and its metabolites.   "
160754|NCT00000191|"     The purpose of this study is to assess carbamazepine as a pharmacotherapy for cocaine     dependence.   "
160769|NCT00000206|"     The purpose of this study is to detect increasing medication dose results in heroin cessation     for patients still using, to determine if decreasing medication dose in patients unable to     tolerate medication dose increases retention, and to determine if blood levels of methadone     or buprenorphine correlate with clinical response.   "
160770|NCT00000207|"     The purpose of this study is to test the efficacy and safety of buprenorphine.   "
160771|NCT00000208|"     The purpose of this study is to explore ways to cross patients over from methadone to     buprenorphine.   "
160794|NCT00000231|"     The purpose of this study is to evaluate buprenorphine and behavioral treatment with and     without contingent payment on compliance with pro-social activities. In addition, we will     examine whether blind naltrexone dosing is effective in indicating naltrexone consumption.   "
160795|NCT00000232|"     The purpose of this study is to determine if four times a subjects' daily maintenance dose     will hold for 120 hours without changes in agonist and antagonist effects.   "
160796|NCT00000233|"     The purpose of this study is to determine how subjects will make changes in the amount of     medication received when given a monetary alternative to buprenorphine.   "
160797|NCT00000234|"     The purpose of this study is to evaluate open buprenorphine dosing with dose choice after     open exposure.   "
160798|NCT00000235|"     The purpose of this study is to determine if six times daily buprenorphine dose is effective     in achieving 120 hour buprenorphine dosing.   "
160799|NCT00000236|"     The purpose of this study is to examine the interactions between buprenorphine and     naltrexone, and to assess how they may directly impact the clinical issues involving:     transferring patients from buprenorphine to naltrexone, developing a non-abusable form of     buprenorphine, and enhancing patient acceptability of naltrexone.   "
160800|NCT00000237|"     The purpose of this study is to examine the long-term efficacy of alternate-day dosing     schedules in promoting treatment compliance in the absence of confounding behavioral     contingencies.   "
160801|NCT00000238|"     The purpose of this study is to assess the degree in which opioid-dependent outpatients     discount the value of an additional maintenance dose of buprenorphine under differing states     of opioid deprivation.   "
160802|NCT00000239|"     The purpose of this study is to examine if chronic buprenorphine administration will generate     supersensitivity to opiates.   "
160804|NCT00000241|"     The purpose of this study is to evaluate the safety and efficacy of flupenthixol decanoate     for treatment of methamphetamine dependence. Also, study will compare flupenthixol with     desipramine in blocking methamphetamine self-administration.   "
160805|NCT00000242|"     The purpose of this study is to compare the efficacy of carbamazepine in treatment of     cocaine-dependence in patients with affective disorders.   "
160806|NCT00000243|"     Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were     previously maintained on methadone. The purpose of this study is to determine the effects of     different doses of buprenorphine/naloxone in treating opioid dependent individuals who were     previously maintained on methadone.   "
160807|NCT00000244|"     The purpose of this study is to evaluate the effects of IV dynorphin in humans during acute     heroin abstinence, in order to determine that dynorphin suppresses acute opiate withdrawal,     reduces opiate craving, and is safe at doses required to produce the above effects.   "
160808|NCT00000245|"     The purpose of this study is to confirm whether a blood level ceiling exists on     desipramine effect in cocaine abuse.   "
160809|NCT00000246|"     The purpose of this study is to verify the hypothesis that the benzodiazepine antagonist,     flumazenil, will reduce acute benzodiazepine withdrawal.   "
160810|NCT00000248|"     The purpose of this study is to evaluate the efficacy and safety of pergolide for treatment     of cocaine dependence.   "
160811|NCT00000249|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. To examine     effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans.   "
160812|NCT00000250|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. To evaluate:     cold water immersion modulates the reinforcing effects of nitrous oxide in healthy     volunteers.   "
160813|NCT00000251|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. To evaluate the     acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide     combinations in healthy volunteers.   "
160814|NCT00000252|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. To examine the     lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of     nitrous oxide in healthy volunteers.   "
160815|NCT00000253|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. To examine the     subjective, psychomotor, and reinforcing effects of nitrous oxide in healthy volunteers. This     is a dose-response analysis.   "
160816|NCT00000254|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. To test the     hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water     immersion pain in healthy volunteers.   "
160817|NCT00000255|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. To examine     differential acute tolerance development to effects of nitrous oxide in humans.   "
160818|NCT00000256|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. Comparisons     between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine     reinforcing effects of brief exposures to nitrous oxide in healthy volunteers.   "
160819|NCT00000257|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. Comparisons     between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To determine     effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous     oxide in healthy volunteers.   "
160820|NCT00000258|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. Comparisons     between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To evaluate the     role of instructions in nitrous oxide subjective effects and choice.   "
160821|NCT00000259|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. Comparisons     between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine     sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and     psychomotor performance.   "
160822|NCT00000260|"     The purpose of this study is to conduct experiments to examine subjective and reinforcing     effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug     abusers and preference procedures will be used to assess reinforcing effects. Comparisons     between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine the     effects of different behavioral contingencies in modulating the reinforcing effects of     nitrous oxide in healthy volunteers.   "
160890|NCT00000330|"     The purpose of this study is to assess the abuse liability and reinforcing effects of     intravenous buprenorphine and buprenorphine/naloxone combinations in heroin-dependent     volunteers   "
160823|NCT00000261|"     The purpose of this study is to evaluate the effects of alcohol history on the subjective and     reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects     underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of     intervention.   "
160824|NCT00000262|"     The purpose of this study is to determine the effects of combined sevoflurane and nitrous     oxide inhalation on mood, psychomotor performance, and the pain response in humans.   "
160825|NCT00000263|"     The purpose of this study is to determine the effects of combined alcohol and nitrous oxide     intake on mood, psychomotor performance, and the pain response in healthy volunteers.   "
160826|NCT00000264|"     The purpose of this study is to examine the subjective, psychomotor, and reinforcing effects     of combined alcohol and nitrous oxide intake in healthy volunteers.   "
160827|NCT00000265|"     The purpose of this study was to characterize mood changes during nitrous oxide inhalation in     patients with different levels of preoperative dental anxiety.   "
160828|NCT00000266|"     The purpose of this study is to evaluate the safety and efficacy of flupenthixol for cocaine     dependence in individuals with schizophrenia/schizoaffective illness.   "
160829|NCT00000267|"     The purpose of this study is to evaluate the safety and efficacy of risperidone for cocaine     dependence in individuals with schizophrenia/schizoaffective illness.   "
160830|NCT00000268|"     The purpose of this study is to evaluate cocaine abuse and Attention Deficit Disorder   "
160831|NCT00000269|"     The purpose of this study is to evaluate the safety and efficacy of pergolide for cocaine     dependence.   "
160832|NCT00000270|"     The purpose of this study is to define temporal profile of brain activation (rCBF) using     Xenon-SPECT and O 15-PET.   "
160833|NCT00000271|"     The purpose of this study is to measure the effect of desipramine in cocaine abusers selected     for major depression or dysthymia.   "
160834|NCT00000273|"     The purpose of this study is to evaluate the effects of treatment medications (methadone,     buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and     smoked heroin self-administration.   "
160835|NCT00000274|"     The purpose of this study is to evaluate the safety and efficacy of flupenthixol and     haloperidol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.   "
160836|NCT00000275|"     The purpose of this study is to evaluate the safety and efficacy of buproprion in treating     individuals with adult attention-deficit hyperactivity disorder (ADHD) and cocaine     dependence.   "
160837|NCT00000276|"     The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.   "
160838|NCT00000277|"     The purpose of this study is to evaluate high and low dose mazindol for cocaine abuse.   "
160839|NCT00000278|"     The purpose of this study is to evaluate disulfiram for cocaine-alcohol abuse.   "
160840|NCT00000279|"     The purpose of this study is to evaluate novel medications for opiate detoxification.   "
160841|NCT00000280|"     The purpose of this study is to evaluate glutaminergic agents for cocaine abuse.   "
160842|NCT00000281|"     The purpose of this study is to evaluate maintenance neuroleptics for Schizophrenic patients     who are cocaine abusers.   "
160843|NCT00000282|"     The purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.   "
160844|NCT00000284|"     The purpose of this study is to determine the effects of cotinine with or without a     transdermal nicotine replacement on tobacco withdrawal symptoms.   "
160845|NCT00000285|"     The purpose of this study is to determine the effects of phenytoin on the self-administration     of smoked cocaine.   "
160846|NCT00000286|"     The purpose of this study is to determine the effects of nefazedone on cocaine     self-administration in depressed and non-depressed female cocaine users.   "
160847|NCT00000287|"     The purpose of this study is to pilot a relapse questionnaire and examine relapse patterns in     female cocaine users.   "
160848|NCT00000288|"     The purpose of this study is to determine the effects of varying doses of cotinine on     cigarette self-administration.   "
160849|NCT00000289|"     The purpose of this study is to determine the effects of various doses of ondansetron     transdermal nicotine replacement on tobacco withdrawal symptoms.   "
160858|NCT00000298|"     The purpose of this study is to determine target dose range of buprenorphine/naloxone     combination tablet that provides therapeutic response in opiate addicts with low to moderate     dependence, and to identify appropriate initial induction dose in opiate addicts with low to     moderate dependence.   "
160859|NCT00000299|"     The purpose of this study is to develop a clinical protocol to detoxify patients from opiates     to naltrexone using buprenorphine and to develop pilot data for a grant application for a     controlled study of the efficacy of the new clinical protocol for outpatients.   "
160891|NCT00000331|"     The purpose of this study is to assess the abuse liability and examine the reinforcing     effects of intravenous buprenorphine and buprenorphine/naloxone combinations in healthy,     non-drug dependent volunteers.   "
160860|NCT00000300|"     The purpose of this study is to test therapeutic benefits of take-home LAAM. (1) Do subjects     with take-home LAAM availability show increased clinical responsibility over subjects     without; (2) Do subjects with take-home LAAM attempt diversion when random recall and other     diversion safeguards are used; (3) Does treatment response correlate with background or drug     use variables at intake, discharge, or during treatment?   "
160861|NCT00000301|"     The purpose of this study is to empirically test a series of medications to: 1) determine     each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective     dose range for each medication. In this study, amantadine is tested.   "
160862|NCT00000302|"     The purpose of this study is to compare liquid and tablet buprenorphine formulations.   "
160863|NCT00000303|"     The purpose of this study is to empirically test a series of medications to: 1) determine     each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective     dose range for each medication. In this study, baclofen is tested.   "
160864|NCT00000304|"     The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an     adjunct in cocaine treatment; an evaluation of the replacement strategy.   "
160865|NCT00000305|"     The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology)     interaction study.   "
160866|NCT00000306|"     The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an     adjunct in concurrent cocaine and opiate dependent patients.   "
160867|NCT00000307|"     The purpose of this study is to evaluate naltrexone as an adjunct in alcoholic cocaine     dependent patients; concurrent relapse prevention theory.   "
160868|NCT00000308|"     The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in     cocaine dependent patients.   "
160869|NCT00000309|"     The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study     measures incorporate an appropriate integration of behavioral and neurobiological indices.   "
160870|NCT00000310|"     The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study     measures incorporate an appropriate integration of behavioral and neurobiological indices.   "
160871|NCT00000311|"     The purpose of this study is to evaluate whether the community reinforcement approach (CRA)     plus contingency management (CM) is more effective overall than CRA only in reducing illicit     opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up     after completion of study protocol, and to compare the efficacy of maintenance on     buprenorphine to methadone when maintenance is combined with CRA only or CRA plus CM.   "
160872|NCT00000312|"     The purpose of this study is to evaluate alterations in the serotonergic system in cocaine     addicts and attempt to dissociate changes secondary to cocaine use from those associated with     premorbid characteristics.   "
160873|NCT00000313|"     The purpose of this study is to evaluate the predictive value of serotonergic alterations for     outcome.   "
160874|NCT00000314|"     The purpose of this study is to evaluate predictive value of M-CPP and fenfluramine     challenges for outcome.   "
160875|NCT00000315|"     The purpose of this study is to determine the density of DA transporters during prolonged     cocaine abuse and during withdrawal from cocaine use. This aim will test the hypothesis that     DA transporters are altered by cocaine abuse and reestablished during withdrawal.   "
160876|NCT00000316|"     The purpose of this study is to determine the density of DA transporters during prolonged     cocaine abuse and during withdrawal from cocaine use. This aim will test the hypothesis that     DA transporters are altered by cocaine abuse and reestablished during withdrawal.   "
160877|NCT00000317|"     The purpose of this study is to develop models for early Phase II testing of potential     medications for cocaine dependence: amoxapine, risperidone and other agents.      The study was a controlled pilot trial of risperidone in opiate-dependent patients on     methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine     craving, and cocaine subjective effects in patients on methadone maintenance who abused     cocaine and whether it had an acceptable side effect profile. This   "
160878|NCT00000318|"     The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly     schedule in a pilot clinical trial.   "
160879|NCT00000319|"     The purpose of this study is to evaluate the efficacy of treating opioid-dependent     individuals with buprenorphine on a thrice-weekly schedule compared to daily dosing.   "
160880|NCT00000320|"     The purpose of this study is to compare subject response to liquid vs. tablet formulations,     to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate     if dose response curve for tablet is equal to liquid form.   "
160881|NCT00000321|"     The purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo     on methamphetamine dependent gay men with AIDS.   "
160882|NCT00000322|"     The purpose of this study is to evaluate efficacy of tyrosine as a treatment for     methamphetamine dependence in an outpatient treatment setting providing group psychosocial     interventions. Examine effect of tyrosine on abstinence, retention in treatment, and     craving.   "
160883|NCT00000323|"     The purpose of this study is to characterize the effects of enadoline compared to     hydromorphone and butorphanol.   "
160884|NCT00000324|"     The purpose of this study is to assess the efficacy of tryptophan vs. placebo, and voucher     payments vs. a control condition, in the treatment of cocaine dependence.   "
160886|NCT00000326|"     The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone     combination tablet for alternate-day dosing and determine whether multiples of the daily dose     are necessary to maintain an effective alternate day dosing regimen.   "
160887|NCT00000327|"     The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF)     buprenorphine/naloxone combination tablet administration and determine whether outcomes are     improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in     which take-home doses are given on intervening days.   "
160888|NCT00000328|"     The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone     combination tablet to methadone for opioid maintenance treatment.   "
160895|NCT00000335|"     The purpose of this study is to determine if hyperactivity accompanies abrupt opiate     withdrawal in heroin addicts, to determine if computerized solid state activity monitors are     capable of quantifying hyperactivity, and to quantify the physical and affective symptoms     occurring during abrupt withdrawal in heroin addicts and morphine's capacity to alleviate     these symptoms.   "
160896|NCT00000336|"     The purpose of this study is to evaluate the efficacy and clinical safety of selegiline in     the treatment of cocaine dependence and to assess neurotoxicity (Magnetic Resonance Imaging,     MRI) post-hoc as a possible variable for future stratification in clinical trials.   "
160897|NCT00000337|"     The purpose of this study is to determine the effects of selegiline on the subjective and     physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical     safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack     dependent population.   "
160898|NCT00000338|"     The purpose of this study is to evaluate clinical safety issues pertaining to lisuride, to     cocaine, and to its interaction in a chronic, crack dependent population, and to determine     how pretreatment with lisuride modifies the subjective as well as physiological effects of     cocaine.   "
160899|NCT00000339|"     The purpose of this study is to evaluate clinical safety issues pertaining to risperidone, to     cocaine and to its interaction, and to determine how pretreatment with risperidone modifies     the subjective as well as physiological effects of cocaine.   "
160900|NCT00000340|"     The purpose of this study is to assess the efficacy of pemoline in treating cocaine and/or     methamphetamine dependent adults with comorbid Adult Attention Deficit Hyperactivity Disorder     (ADHD).   "
160901|NCT00000341|"     The purpose of this study is to evaluate the steady-state pharmacokinetics and     bioavailability of buprenorphine sublingual tablets vs. sublingual solution.   "
160902|NCT00000342|"     The purpose of this study is to evaluate clinical safety and pharmacological efficacy in the     treatment of cocaine dependence, to evaluate impact of treatment on craving, and to correlate     evidence of baseline neurotoxic damage of cocaine with treatment outcome and clinical     side-effects.   "
160903|NCT00000343|"     The purpose of this study is to identify the neurophysiologic indicators of cocaine or     methamphetamine use and withdrawal, to examine the relationship between subjects' reports of     depression, craving, and stimulant use, and neurophysiologic measures, and to identify     neurophysiologic measures which can be used to identify new treatments for stimulant     dependence.   "
160904|NCT00000344|"     The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone     sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.   "
160905|NCT00000345|"     The purpose of this study is to assess the safety of lofexidine in the treatment of     opiate-dependent individuals.   "
160906|NCT00000346|"     The purpose of this study is to characterize the cognitive performance of methamphetamine     abusers by comparing them with cocaine abusers and normal controls.   "
160907|NCT00000347|"     The purpose of this study is to evaluate pharmacological efficacy and clinical safety of     risperidone in the treatment of cocaine and amphetamine dependence.   "
160908|NCT00000348|"     The purpose of this study is to evaluate safety issues pertaining to dihydrexidine (DHX), to     cocaine, and to its interaction, and to determine how pretreatment with DHX modifies the     subjective as well as physiological effects of cocaine infusion.   "
160909|NCT00000349|"     The purpose of this study is to evaluate clinical safety issues pertaining to flupenthixol,     to cocaine, and to their interaction, and to determine how pretreatment with flupenthixol     modifies the subjective as well as physiological effects of cocaine. Taken together, these     relatively D-1 selective agents can help determine the extent to which DA-1 binding affects     the reinforcing effects of stimulants.   "
160910|NCT00000350|"     The purpose of this study is to determine whether DAT availability, assessed by WIN binding,     in the striatum is altered in cocaine or methamphetamine dependence. To determine whether DA     synthesis capacity, assessed by FDOPA uptake, in the striatum is altered in Coc or Meth     dependence. To determine whether the PET tracers, WIN or FDOPA, will differentiate Meth     induced alterations from those induced by Coc use. To determine whether the PET     characterization of striatal alterations observed at 3-5 days since last drug use persists at     least 3 months after last drug use.   "
160911|NCT00000351|"     Part II: Examine cognitive performance of stimulant abusers (methamphetamine and cocaine)     during recovery by assessing their cognitive function at monthly intervals.   "
160912|NCT00000352|"     The purpose of this study is to determine if addition of dextromethorphan to a stable dose of     methadone in opioid dependent subjects will significantly affect physical and psychological     aspects of opioid tolerance.   "
160913|NCT00000353|"     The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone     sublingual tablet formulation as an office-based therapy for opiate dependence treatment.   "
160914|NCT00000354|"     The purpose of this study is to determine the safety of lofexidine in the treatment of opiate     withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to     alleviate opiate withdrawal signs and symptoms.   "
160915|NCT00000355|"     The purpose of this study is to evaluate the behavioral and physiological effects of     buprenorphine and naloxone, both alone and in combination.   "
160916|NCT00000356|"     The purpose of this study is to determine the pharmacokinetics of L-alpha-acetylmethadol     (LAAM) in adults transferred from methadone maintenance treatment for opiate dependence.   "
160918|NCT00000358|"     The purpose of this study is to determine the safety of lofexidine in the treatment of opiate     withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to     alleviate opiate withdrawal signs and symptoms.   "
160974|NCT00000547|"     To determine if the chronic administration of enalapril, an inhibitor of angiotensin     converting enzyme (ACE), reduces progression of cardiac dysfunction in pediatric oncology     patients who have received anthracyclines, and who are not currently on digoxin, diuretics,     or vasodilators for heart failure.   "
160919|NCT00000359|"     The purpose of this study was to determine the relative short- and long-term efficacy of     several physical treatment paradigms commonly employed for the treatment of benign paroxysmal     positional vertigo (BPPV), including the canalith repositioning (Epley) maneuver, the     liberatory (Semont) maneuver, the Brandt-Daroff exercises and nonspecific vestibular     habituation exercises. These procedures involve exercises and head manipulations. Vertigo     intensity and frequency, the presence/absence of slow-phase eye movements, the degree of     dizziness handicap and acts of daily living (ADL) were assessed. The study also ascertained     the effects of co-morbid conditions on the response to treatment. While BPPV is a common and     significant public health problem that has been recognized for several decades, this is the     first systematic study of the relative treatment efficacy of different physical treatment     modalities for this disorder.   "
160920|NCT00000361|"     The purpose of this study is to determine whether prednisone, methotrexate, and     cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing     loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it     is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to     suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III,     outpatient study. All study participants will be assigned to one of four different groups     testing the experimental use of drugs. The study is scheduled to run for 18 months, with a     minimum of 11 visits per participant.   "
160921|NCT00000362|"     The purpose of this study is to determine whether chin-down posture or use of a thickened     liquid diet is more effective in the prevention of aspiration and aspiration pneumonia in     patients with Parkinson's disease and/or dementia. Liquid aspiration is the most common type     of aspiration in older populations, especially those suffering from debilitation, dementia,     and depression. Pneumonia may develop as a consequence of aspiration and is the fifth leading     cause of death in the US among persons age 65 years and over. Current treatment involves     either use of chin-down position with swallowing or use of thickened liquids in the diet,     without any clear evidence supporting the use of one treatment over the other. This is a     Phase III inpatient and/or outpatient study in which all participants will be randomly     assigned to either the chin-down position or the thickened liquid treatment group based on     swallowing function during a modified barium swallow. This study is scheduled to recruit     patients for a three-year period; participation by each individual patient spans no more than     three months after entry.   "
160922|NCT00000363|"     Acute otitis media is one of the most common diseases of childhood and is one of the major     causes of hearing loss in children. Despite the availability of effective antibiotic therapy     for otitis media, treatment failures, persistent effusions, and recurrences are common. This     Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a     corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes     of patients with acute otitis media. This study is targeted to recruiting 200 infants (age     less than one year); patient (and parent) participation is estimated to continue for one year     after enrollment.   "
160923|NCT00000367|"     The purpose of this study is to design a program to prevent suicide in elderly patients by     educating patients, their families, and physicians on depression and suicidal thoughts.      A program to prevent suicide in elderly patients needs to be developed. Since elderly     patients frequently have doctor's visits, it may be best to have a suicide prevention program     based in the patient's doctor's office.      When an older person visits a primary care physician, he/she will check for signs of     depression, including thoughts of suicide. The doctor will speak to the patient about     depression and how to recognize it. If the individual is diagnosed with depression, the     doctor will offer treatment. During this study, the information the doctor collects will be     used to evaluate the effectiveness of the program. The study will last for 2 years.      Eligibility for this study is age of at least 60 years and diagnosis of depression.     (Depression required for 920 of the 1200 patients; 280 patients should have no symptoms of     depression.)   "
160924|NCT00000368|"     Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of     panic disorder (PD). The purpose of this study is 1) to determine whether nine months of     maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of     sustained improvement; and 2) to determine the acute acceptability and efficacy of medication     therapy or continued CBT alone among patients who fail to respond sufficiently to an initial     course of CBT alone.      It has been found that patients with PD respond as well to CBT or medication alone as they do     to a combination of the two. Since the combined treatments are expensive and CBT is     associated with less risk of medical toxicity compared to medications, CBT alone will be used     first.      All patients will first receive CBT alone. If the patient responds to this therapy, the     patient will be assigned randomly (like tossing a coin) to 1 of 2 groups. One group will     continue to receive CBT (maintenance therapy) for 9 months. The other group of responders     will not receive any further therapy. If a patient does not respond to CBT alone, he/she will     be assigned randomly to 1 of 2 different groups. One group will receive paroxetine; the other     will continue to receive CBT for a longer period. The response to treatment will be evaluated     to see which regimen works best to treat PD. The study will last approximately 3 years.      An individual may be eligible for this study if he/she has panic disorder with no more than     mild agoraphobia (fear of being in public places) and is at least 18 years old.   "
160948|NCT00000392|"     To evaluate the chemical efficacy and safety of intranasally administered peptide T on     neurocognitive function in HIV seropositive individuals.      Previous studies have shown that treatment with peptide T can result in cognitive improvement     in HIV-infected patients.      Patients are randomized to receive either peptide T or placebo for the first 6 months. All     patients then receive open-label peptide T for approximately 6 additional months.     Neuropsychologic tests are used to determine drug effects.   "
160925|NCT00000369|"     The purpose of this study is to see if adding a regimen of individualized psychotherapy can     help bipolar I patients who are on lithium.      While having a manic or depressed episode patients will be assigned randomly (like tossing a     coin) to receive appropriate medication either with or without additional individual     psychotherapy. If a patient responds well, he/she will again be assigned randomly to receive     further preventative treatment in which medication will be managed either with continued     medication clinic visits alone or with additional individual psychotherapy (the patient may     not receive the same additional treatment this time). Patient response to treatment will be     evaluated throughout the study. If manic/depressive symptoms return at any point during the     study, the patient will be treated with appropriate medication and will continue the study.      An individual may be eligible for this study if he/she:      Has Bipolar I disorder, is experiencing a manic or depressed episode at the time of study     entry, and is at least 18 years old.   "
176037|NCT00144599|"     This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in     patients with sJIA.   "
160926|NCT00000370|"     Social phobia is a very common and debilitating disorder, with public speaking anxiety being     the most common fear. Psychologists have found that treating patients for their fear of     public speaking, through cognitive-behavioral treatment (talk-based therapy) or exposure     treatment (where participants participate in actual public speaking sessions), not only helps     patients overcome this fear but also helps them overcome their more general social fears.     However, little is known about how this change occurs during therapy. This study tries to     identify the factors that contribute most to successful therapy.      Patients are assigned randomly (like tossing a coin) to 1 of 3 groups. Group 1 will receive     cognitive-behavioral treatment and Group 2 will receive exposure treatment. Group 3 will not     receive treatment. Study leaders will monitor patient response to treatment through     behavioral tests and assessments.      An individual may be eligible for this study if he/she:      Has social phobia with public speaking anxiety.   "
160927|NCT00000371|"     To characterize further the effects of D-cycloserine augmentation of antipsychotic treatment     on negative symptoms, performance on neurocognitive tasks, and on markers for glutamatergic,     dopaminergic and serotonergic function in serum and cerebrospinal fluid. To determine if     negative symptoms and cognitive function improve over time, if these improvements     meaningfully impact quality of life factors, if they correlate with markers of neuronal     function, and if subpopulations can be identified according to response.      Dysfunction of glutamatergic neuronal systems has recently been implicated in the     pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the     NMDA receptor can reproduce in normals the positive symptoms, negative symptoms, and     cognitive deficits of schizophrenia. Furthermore, glutamatergic dysfunction may alter     forebrain dopaminergic neuronal activity, a system central to the antipsychotic action of     typical neuroleptics. It is believed that enhancing NMDA receptor function by systemic     treatment with D-cycloserine, a partial agonist at the glycine modulatory site of the NMDA     receptor, will reduce symptoms in schizophrenia.      Sixty schizophrenic outpatients with prominent, primary negative symptoms are treated with     antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month,     fixed-dose trial. The primary outcome measure is the total score on the Scale for Assessment     of Negative Symptoms (SANS). A neuropsychological battery, which emphasizes tests sensitive     to prefrontal cortical function, is administered. Blood is obtained at several time points     and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine, glutamate, HVA,     and 5HIAA.   "
160928|NCT00000372|"     The purpose of this study is to compare the effects of D-cycloserine and glycine for treating     negative symptoms (such as loss of interest, loss of energy, loss of warmth, and loss of     humor) which occur between phases of positive symptoms (marked by hallucinations, delusions,     and thought confusions) in schizophrenics.      Clozapine is currently the most effective treatment for negative symptoms of schizophrenia.     Two other drugs, D-cycloserine and glycine, are being investigated as new treatments.     D-cycloserine improves negative symptoms when added to some drugs, but may worsen these     symptoms when given with clozapine. Glycine also improves negative symptoms and may still be     able to improve these symptoms when given with clozapine. This study gives either     D-cycloserine or glycine (or an inactive placebo) with clozapine to determine which is the     best combination.      Patients will be assigned to 1 of 3 groups. Group 1 will receive D-cycloserine plus     clozapine. Group 2 will receive glycine plus clozapine. Group 3 will receive an inactive     placebo plus clozapine. Patients will receive these medications for 8 weeks. Negative     symptoms of schizophrenia will be monitored through the Scale for the Assessment of Negative     Symptoms, Positive symptoms will be monitored through the Positive and Negative Syndrome     Scale, and additionally subjects will complete the Brief Psychiatric Rating Scale and the     Global Assessment Scale.      An individual may be eligible for this study if he/she is 18 to 65 years old and has been     diagnosed with schizophrenia.   "
160929|NCT00000373|"     The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum     obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and     involuntary body movements (tics).      There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on     type of OCD, determined by medical history and family member interviews. In Part 2, patients     are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone,     either haloperidol or an inactive placebo will be added to the FVX regimen; patients will     take this drug combination for 4 weeks. Patients will be monitored throughout the trial.   "
160930|NCT00000374|"     This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and     risperidone (Risperdal®) can help patients with first-episode schizophrenia.   "
160961|NCT00000534|"     To evaluate the efficacy of 2 grams per day of oral calcium supplementation in reducing the     combined incidence of hypertensive disorders of pregnancy: pre-eclampsia, eclampsia, and the     HELLP Syndrome (hypertension, thrombocytopenia, hemolysis, and abnormal liver function). The     National Institute of Child Health and Human Development (NICHD) initiated the trial in 1991,     with joint funding provided by the National Heart, Lung, and Blood Institute in fiscal years     1992, 1993, and 1995.   "
160962|NCT00000535|"     To test the efficacy of weight loss and sodium restriction, alone and combined, in     maintaining the normotensive state following withdrawal of antihypertensive medications in an     elderly cohort. Conducted in collaboration with the National Institute on Aging.   "
160931|NCT00000375|"     The purpose of this study is to compare the safety and effectiveness of two treatments to     prevent relapses in seriously ill patients with major depressive disorder (MDD) who have     responded to electroconvulsive therapy (ECT). Patients will either continue to receive ECT     (continuation electroconvulsive therapy [C-ECT]), or they will be treated with antidepressant     medications.      ECT is a highly effective treatment for MDD; however, relapses are a major concern. To     prevent relapse in patients who have responded to ECT, the common treatment is     antidepressants as continuation therapy (following the initial therapy in order to continue     treating the disorder). Relapses, however, can still occur even after antidepressant     continuation therapy. This study will evaluate a potent antidepressant combination in order     to prevent relapse. C-ECT is another option that needs to be tested.      If the patient responds to the first round of ECT, he/she will be assigned randomly (like     tossing a coin) to either continue receiving ECT or to receive an antidepressant combination     of nortriptyline plus lithium (NOR-Li) for 6 months. The patient will have psychological     tests before, shortly after, and 3 months after the first round of ECT, and at the end of the     6-month continuation trial. Patients will be monitored for symptoms and side effects. All     patients will have urine tests to test for drug abuse.      An individual may be eligible for this study if he/she:      Has major depressive disorder and responds positively to ECT treatment and is 18 to 80 years     old.   "
160969|NCT00000542|"     To determine if the combined incidence of nonfatal myocardial infarction and coronary heart     disease death differs between diuretic-based and each of three alternative antihypertensive     pharmacological treatments. Also, to determine, in a subset of this population, if lowering     serum cholesterol with a HMG CoA reductase inhibitor in older adults reduces all-cause     mortality compared to a control group receiving usual care. Conducted in conjunction with the     Department of Veterans' Affairs.   "
160932|NCT00000376|"     To develop an effective combined cognitive therapy (CT) plus drug treatment for patients with     drug-resistant depression (DRD) (i.e., depression that is refractory to medication). To     develop a manual for combined treatment for DRD that integrates three existing forms of CT     (CT for depression, CT for personality disorders, and CT for anxiety disorders), and that     specifies interventions for combining CT and medication when two therapists (psychotherapist     and pharmacotherapist) provide the treatment. To obtain outpatient, randomized control, pilot     data on the clinical value of the combined CT plus drug treatment, using the standard     antidepressant desipramine (DMI), to obtain effect sizes and to determine if the treatment     merits further investigation in a clinical trial. To develop a therapist adherence measure     for the combined treatment.      Patients receive 1 of 2 treatments: CT plus DMI (n = 18) or DMI plus Clinical Management (n =     12). The first 6 of the 18 CT plus DMI patients are treated in a pre-pilot phase before     randomization begins. All treatments continue for 6 months. The major assessment battery is     administered at intake, 3 months, 6 months, and follow-up 6 months later. All treatments are     closely monitored via audiotapes and supervision for purposes of developing and refining the     CT plus drug treatment. The audiotapes are also used for development of the adherence     measure. The primary outcome measures are Hamilton Rating Scale for Depression scores, Beck     Depression Inventory scores, percent of patients who achieve clinical remission of symptoms,     and percent showing attrition from treatment. Compliance with the treatment regimens is also     a targeted and measured outcome variable.   "
160933|NCT00000377|"     The purpose of this study is to compare the effectiveness of two doses of nortriptyline in     elderly patients whose depression returned after stopping treatment. Nortriptyline is an     antidepressant.      This study enrolls patients who were treated for depression in an earlier research study and     whose depression has returned since stopping treatment. Patients are treated for 4 months to     bring the depression under control. Patients are then assigned randomly (like tossing a coin)     to receive either the full dose of nortriptyline or half the usual dose of nortriptyline.     Patients continue taking nortriptyline for 2 years or until a major depression returns.     Throughout the study, patients are monitored for symptoms of depression and other side     effects.   "
160934|NCT00000378|"     The purpose of this study is to compare the safety and effectiveness of a select serotonin     re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in     outpatients over the age of 60 who have major depression.      SSRIs are effective in the treatment of major depression. However, there is also evidence     that SSRIs may be significantly less effective than TCAs for patients with late-life major     depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more     widely prescribed, it is important to determine which of these types of antidepressants works     best to treat these patients.      Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a     TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of     life. If a patient responds to treatment, he/she will participate in a 6-month continuation     phase in which he/she will continue to receive the same medication.      An individual may be eligible for this study if he/she:      Has unipolar major depression (with some exceptions) and is over 60 years old.   "
160935|NCT00000379|"     The purpose of this study is to compare two treatments for post-traumatic stress disorder     (PTSD): fluoxetine (an antidepressant) and Eye Movement Desensitization and Reprocessing     (EMDR, a psychological treatment in which the patient is led through the memory of a     traumatic experience in order to heal him/herself).      There are a variety of therapies used to treat PTSD, but the effectiveness of medication     alone vs an exposure treatment, such as EMDR, has not been tested.      Patients will be assigned randomly (like tossing a coin) to one of three groups for 8 weeks     of treatment. Group 1 will receive fluoxetine; Group 2 will receive EMDR; and Group 3 will     receive inactive placebo. Patients will then stop treatment and have evaluations, including     psychological tests, at the time treatment is stopped, 8 weeks later, and at 6 months.      An individual may be eligible for this study if he/she:      Has PTSD and is 18 to 65 years old.   "
160936|NCT00000380|"     The purpose of this study is to examine the effects of giving growth hormone releasing     hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen     replacement therapy (ERT).      Many older men and women complain of sleep disturbances. GHRH has been used successfully to     treat sleep disorders in young men and may help older men and women.      40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an     inactive placebo.      An individual may be eligible for this study if he/she is a healthy older man or woman with     sleep disturbances, and is on estrogen replacement therapy (women).   "
160937|NCT00000381|"     The purpose of this study is to see if it is safe and effective to use fluoxetine to treat     children and adolescents with Generalized Anxiety Disorder (GAD).      Anxiety disorders are one of the most common psychiatric disorders in children and     adolescents, and can cause disturbances in the child's school, social, and family lives.     Having an anxiety disorder puts a child at risk for depression and drug abuse, and appears to     continue into adulthood. There is very little information on anxiety medications for     children.      Children will be assigned randomly (like tossing a coin) to receive either fluoxetine or an     inactive placebo for 12 weeks. Each child will be monitored for symptoms and side effects     throughout the study. He/she will have blood tests at Weeks 4, 8, and 12 to measure drug     levels in the blood. The study will last for 12 weeks.      A child is eligible for this study if he/she:      Is 8 to 17 years old and has anxiety disorder.      A child will not be eligible for this study if he/she:      Has current major depression, panic disorder, or obsessive-compulsive disorder, or abuses     alcohol or drugs.   "
160950|NCT00000394|"     This study will look at the effectiveness of acupuncture for treating carpal tunnel syndrome     (CTS). People who participate in this study will have CTS that has been diagnosed by physical     examination and neurological testing. We will randomly assign study participants to receive     one of the three types of acupuncture either once, twice, or three times weekly for a total     of 6 weeks. Acupuncturists will treat one group of patients with true acupuncture. They will     give the other two groups of patients one of two alternative acupuncture treatments that do     not use the true acupuncture points. The patients and evaluators will not know the type of     acupuncture (True, Alternative 1, or Alternative 2) that is being used. The acupuncturists     will not communicate with the patients and will not be involved in patient evaluation.   "
160938|NCT00000382|"     The purpose of this study is to compare 2 approaches (interventions) to prevent child-abuse     (maltreatment) in infants: Psychoeducational Home Visitation (PHV) vs Infant-Parent     Psychotherapy (IPP). Non-maltreated infants and their mothers are studied as a comparison     group.      Twelve-month-old infants and their mothers are assigned randomly (like tossing a coin) to     receive 1 of 3 types of intervention for 12 months: 1) Services normally available in the     community when a family is reported for child maltreatment (Child Protective Services, CPS);     2) CPS involvement plus weekly PHV; 3) CPS involvement plus weekly IPP. Intervention will be     provided until the infant's second birthday. All mother-infant pairs (including comparison     non-maltreated infants and their mothers) will be assessed when the infant is 12, 18, 24, 36,     and 48 months old. Assessments will look at the effectiveness of the intervention in     preventing child maltreatment, improving parenting, and reducing future abuse. The study will     last for 3 years.      Eligibility includes a mother and her 12-month-old child that has been abused by her (the     mother) or the father. (Non-maltreated infants and their mothers also will be enrolled.)   "
160939|NCT00000383|"     The purpose of this study is to compare the effectiveness of two psychological therapies used     to treat PTSD in children who have recently been sexually abused: Trauma-Focused Cognitive     Behavioral Therapy (TF-CBT) vs Child Centered Therapy (CCT).      Child sexual abuse is a common experience that has serious mental health consequences,     including the development of PTSD and other abuse-related problems.      All children will be assigned randomly (like tossing a coin) to receive either SAS-CBT or NST     at each of two sites. In addition, the parents and the child will receive individual therapy     for 12 weeks. The child will be monitored to evaluate his/her response to therapy.     Assessments will take place before and just following treatment, and then 6 and 12 months     post-treatment.      A child may be eligible for this study if he/she:      Has been sexually abused, is suffering from PTSD as a result of the abuse, and is 8 to 14     years old.   "
160940|NCT00000384|"     The purpose of this study is to compare 3 treatments for children with OCD: medication     (sertraline, SER) alone vs OCD-specific therapy (Cognitive Behavior Therapy, CBT) vs     medication plus therapy. Some patients will receive an inactive placebo (PBO) instead of     medication and/or Educational Support (ES, non-psychological treatment) instead of therapy.      One in 200 children suffer from OCD, but few receive appropriate treatment. Both CBT and     medication seem to be effective, but their effectiveness, alone and in combination, has not     been evaluated.      There are 2 phases to this trial. In Phase I the child will receive 1 of the following 6     treatments for 12 weeks: 1) SER alone; 2) pill PBO alone; 3) CBT alone; 4) SER plus CBT; 5)     SER plus ES; 6) pill PBO plus ES. If the child responds to treatment, he/she will go on to     Phase II in which the treatment will be slowly reduced, then stopped (discontinued), over     time to test the treatment's durability. The child will be evaluated at Weeks 1, 4, 8, 12     (Phase I treatment), and Weeks 16, 20, 24, and 28 (Phase II discontinuation) to see how     effective and durable the treatment is in treating your child's OCD.      A child may be eligible for this study if he/she:      Has obsessive-compulsive disorder (OCD) and is 8 - 16 years old.   "
160941|NCT00000385|"     This study will examine the long-term effects of lithium used to treat children and     adolescents with aggressive conduct disorder (severe aggression).   "
160942|NCT00000386|"     The purpose of this study is to evaluate a behavioral treatment program for children and     adolescents with OCD and their families. Exposure and Response Prevention (ERP) behavior     therapy, in which the patient is gradually exposed to the object or situation that causes     anxiety and is taught to refrain from responding in a compulsive manner, is combined with     family counseling (Family Treatment Program). This treatment will be compared to Relaxation     Training (RT).      OCD is a long-term, often disabling disorder that can cause significant family disruption.     ERP is a promising treatment for children with OCD, and it is thought that family     participation (through the Family Treatment Program) may be a helpful addition. RT is a     common treatment for anxiety.      Patients are assigned randomly (like tossing a coin) to receive either the ERP/Family     Treatment Program or RT. Both treatments will be delivered over 12 90-minute outpatient     sessions to youngsters and their families. All participants (patients and family members)     will be assessed for treatment response each month during treatment, after treatment is     finished, and then at 2 follow-up visits over the following 6 months.      A child/adolescent may be eligible for this study if he/she:      Has obsessive-compulsive disorder (OCD), is medication-free, and is 8 to 17 years old.   "
160963|NCT00000536|"     To compare the effects of two levels of dietary sodium on blood pressure in Black men and     women, and to determine what factors predict the degree of response.   "
160943|NCT00000387|"     The purpose of this study is to test the effectiveness of a family-centered, community-based,     self-management intervention (Self-Management Therapy) for adolescents with schizophrenia.     The study will test the intervention's effectiveness in improving the adolescents' behavior,     thinking, mood, and use of substances such as drugs and alcohol. The study also will look at     the effects of the patient on the family.      The intervention involves training in recognizing symptoms of schizophrenia and in stress     management, problem-solving, and social skills. Parents and siblings are included to gain     knowledge and skills to support the adolescents.      The Self-Management Therapy intervention is administered in small multiple-family groups in     12 sessions over 7-1/2 months. The effects of the intervention on the patient and his/her     family are assessed prior to treatment, after 6 sessions, after 12 sessions, and in a     follow-up visit 6 months after completion of sessions.      A child may be eligible for this study if he/she:      Is 15 to 19 years old and has been diagnosed with schizophrenia.   "
160951|NCT00000395|"     This study looks at how the arthritis drug methotrexate works in low doses to treat     rheumatoid arthritis. (High doses of methotrexate are used to treat some types of cancer.)     Methotrexate blocks the action of the B-vitamin known as folic acid. We are studying the     biochemical reactions affected by this vitamin because we think that blocking many of these     reactions may be necessary for methotrexate to work in treating rheumatoid arthritis. Through     these studies, we hope to gain a better understanding of how this drug and related drugs work     as treatments for arthritis.   "
160970|NCT00000543|"     To determine of providing calcium supplementation to women with pre-existing hypertension     reduces the level of blood pressure, requirement for antihypertensive drugs, and incidence of     pre-eclampsia.   "
160971|NCT00000544|"     To test the effectiveness of dietary patterns in lowering blood pressure.   "
160972|NCT00000545|"     To implement a culturally appropriate school-based, multicenter, randomized trial that     promotes healthful eating behaviors and increases physical activity to prevent obesity in     pre-adolescent upper elementary American Indian students.   "
160944|NCT00000388|"     This trial is a continuation of the Multimodal Treatment Study of Children with Attention     Deficit Hyperactivity Disorder (MTA Study). Continuation Aim 1 is to track the persistence of     intervention-related effects as the MTA sample matures into mid-adolescence, including     subsequent mental-health and school-related service utilization patterns as a function of MTA     treatment experience (treatment assignment) and outcome (degree of treatment success at 14     mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of     long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive     skills; peer relations) that may influence adolescent functioning (either independent of or     through initial treatment assignment and/or 14-month treatment outcomes); and to compare how     these predictors, mediators, and moderators are similar or dissimilar within the normal     comparison group. Aim 3 is to track the patterns of risk and protective factors (including     their mediation or moderation by initial treatment assignment and/or outcome) involved in     early and subsequent stages of developing substance-related disorders and antisocial     behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of     treatment success on later academic performance, achievement, school conduct, tendency to     drop out, and other adverse school outcomes.      In the original MTA design, patients were randomly assigned to 1 of 4 treatment conditions:     (1) medication only; (2) psychosocial only; (3) combined (medication and psychosocial); or     (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14     months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original     MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. This     continuation extends the follow-up to assessments at 36, 60, and 84 months after treatment.      A child may be eligible for this study if he/she:      Is 7 - 9 years old, and has Attention Deficit Hyperactivity Disorder (ADHD).   "
160945|NCT00000389|"     The purpose of this study is to see if it is effective to treat children with anxiety     disorders with fluvoxamine.      Fluvoxamine has been successfully used to treat obsessive-compulsive disorder (OCD) in adults     and children. Anxiety disorders other than OCD, such as generalized anxiety disorder, social     phobia, or separation anxiety, are very common in youth and are not always responsive to     behavioral therapies alone. These disorders may respond to fluvoxamine.      A child will be evaluated for 3 weeks before he/she is assigned randomly (like tossing a     coin) to receive either fluvoxamine or an inactive placebo for 8 weeks. After this     double-blind phase (neither the child/parents nor the doctor know which treatment is being     given), the child will have the option of continuing treatment during a 4-month open-label     extension period (both the child/parents and the doctor know which the child is receiving).      A child may be eligible for this study if he/she:      Is 6 to 17 years old and has been diagnosed with an anxiety disorder (i.e., generalized     anxiety disorder, social phobia, or separation anxiety).   "
160946|NCT00000390|"     To test the effectiveness treating AIDS related depression with imipramine hydrochloride.      Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due     to the relentless course of HIV infection, there is a certain reluctance to treat the     associated depression. In other illness, it has been proven that treating the depression     often results in improvement of overall health status.      This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride     every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating     Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over     phase in which placebo non responders are entered into an open-label study and given     imipramine hydrochloride.   "
160947|NCT00000391|"     To study the safety and toxicity of intranasal peptide T (D-Ala-1-peptide-T-amide) in humans,     and to find out how quickly and how much of a given dose enters the bloodstream and how     quickly it leaves the bloodstream. To obtain information on the ability of intranasal peptide     T to prevent, halt, and/or reverse the effects of AIDS on the central nervous system.      Studies have shown that AIDS is caused by a retrovirus. This virus works by inactivating or     destroying human CD4 cells (which are part of the human immune system). This in turn leads to     the observed immunologic defects and related illnesses, including HIV encephalopathy (disease     of the brain). One method of preventing AIDS is to prevent HIV from entering the cell. HIV     binds to the receptor CD4 site. Peptide T also binds to this site, and thus by competing for     that site, can block the binding of the virus to its receptor. Preliminary animal and human     studies indicate that peptide T is safe at the doses selected for this trial.      Thirty patients with AIDS or AIDS related complex (ARC) are entered into the study to receive     an increasing schedule of three dosage levels of intranasal peptide T for 12 - 16 weeks     followed by a 1-month off-drug follow-up period and a subsequent 1-month return to the drug.     All patients receive an initial intravenous test dose of peptide T. The test dose is     administered over 1 hour, followed by an observation period of 8 hours in the outpatient     clinic.   "
160964|NCT00000537|"     To compare the effects of two stress reduction techniques, Transcendental Meditation (TM) and     Progressive Muscle Relaxation (PMR), on the control of mild hypertension in elderly Blacks     with hypertension.   "
160949|NCT00000393|"     To study the safety, toxicology, and activity of Peptide T (D-Ala-1-peptide-T-amide) in     humans and to find out more about the ability of peptide T to prevent, halt, and/or reverse     AIDS-associated immunologic disturbances.      Recent information suggests that the central nervous system (CNS) is often impaired in     HIV-infected individuals. The dysfunction of the CNS may be either a direct or an indirect     result of HIV infection. One method to prevent HIV infection is to block entry of the virus     into the cells of the body. Peptide T shows laboratory evidence of blocking the entrance of     HIV into cells that are susceptible to HIV infection. Studies that have been done indicate     that peptide T is nontoxic in the doses that are used in this study.      AIDS patients with minimal (group 1) or moderate (group 2) cognitive dysfunction (mental     impairment) receive an increasing schedule of three dosage levels of peptide T. All patients     receive an intravenous (IV) dose of peptide T for 10 days followed by the intermediate dose     and then the highest dose, each intravenously for 10 days. Following successful completion of     3 IV doses, four patients participate in an intranasal pharmacokinetic (blood level study)     dosage trial of 3 doses (different from IV) of peptide T once for each of 3 successive days.     Follow-up continues for up to 1 year.   "
160968|NCT00000541|"     To determine if supplements of vitamin C, vitamin E, beta-carotene, and B-vitamins (a     combination of folic acid, vitamins B6 and B12) reduce risk of major cardiovascular events in     high risk women with a prior history of atherosclerotic cardiovascular disease. The trial is     a companion to the Women's Health Study (WHS), a primary prevention trial of vitamin E and     aspirin in a low risk population of women.   "
160973|NCT00000546|"     To evaluate the effectiveness of stress reduction with Transcendental Meditation (TM) on left     ventricular hypertrophy, left ventricular function, blood pressure, psychosocial stress and     quality of life, and cardiovascular disease risk factors.   "
160952|NCT00000396|"     Research has shown that people with arthritis can improve their ability to cope with     arthritis pain with the help of patient education programs, which teach people things they     can do to help manage their disease. However, we do not know much about the effects of     arthritis patient education programs on minorities, such as urban African Americans.      We will gather participants for this project through a faith-based community network. The     project is made up of four studies that will provide information about culturally relevant     ways of reaching urban African Americans with arthritis and providing patient education that     addresses arthritis care needs of the African American community. This project will also     provide information on the effectiveness of an arthritis self-help course for urban African     Americans. We hope to better understand the differences among cultural groups and how these     differences should affect the design of culturally appropriate patient education.   "
160953|NCT00000397|"     This study tests the effectiveness of a nondrug treatment for the insomnia that often occurs     in people with fibromyalgia. The treatment is a type of psychotherapy called     cognitive-behavioral therapy. Cognitive-behavioral therapy combines cognitive therapy, which     can modify or eliminate thought patterns contributing to the person's symptoms, and     behavioral therapy, which aims to help the person change his or her behavior.   "
160954|NCT00000398|"     Fibromyalgia (FM) is one of the most common rheumatic diseases (conditions or disorders that     cause pain or stiffness in the joints, muscles, or bones). It affects 6 million Americans and     up to 20 percent of patients seen by doctors who specialize in treating rheumatic diseases.     This study will evaluate the effects of two of the most promising nondrug treatments for FM:     coping skills training and physical exercise training. We will randomly assign each of 180     patients diagnosed with FM to one of four groups: coping skills training (CST), physical     exercise training alone, CST plus physical exercise training, or a waiting list (nontreatment     group). We will look at the separate and combined effects of CST and physical exercise     training and evaluate how changes in aerobic fitness, self-effectiveness (a person's belief     in his or her ability to reach a goal, such as managing one's own disease), and negative     pain-related thoughts relate to improvements in pain and disability.   "
160955|NCT00000399|"     We started the Bone, Estrogen, Strength Training (BEST) study in the fall of 1995 at the     University of Arizona, Tucson, Arizona. The BEST study is the largest of its kind. It looks     at the effects of hormone replacement therapy and strength training exercise on bone mineral     density. (Bone mineral density affects bone strength and the risk of osteoporosis.) Six     groups of about 300 women each participated in this osteoporosis prevention study. In 1998,     the BEST study received additional funding to examine for another 2 years the long-term     effects of strength training on bone mineral density. By 2001 we will have finished analyzing     the results for all study groups on the 1-year effects of exercise on bone, as well as     additional analyses on the effects of 2, 3, and 4 years of strength training and     weight-bearing exercise on bone.   "
160956|NCT00000529|"     To assess the impact of tamoxifen on development of breast cancer, coronary heart disease,     and bone fractures. The National Cancer Institute initiated the prevention trial under its     National Surgical Adjuvant Breast and Bowel Project (NSABP). The National Heart, Lung, and     Blood Institute provided support to obtain blood pressure and lipid measurements, and     lipoprotein and selected coagulation factor measurements in a subsample.   "
160957|NCT00000530|"     To determine the relative efficacy of usual medical care and a course of treatment by thermal     biofeedback in reducing vasospastic attacks characteristic of Raynaud's syndrome. Also, to     confirm the frequency and severity of attacks, examine the role of psychophysiological     factors in precipitating attacks, and assess the influence of treatment on health quality of     life.   "
160958|NCT00000531|"     To evaluate if use of an implantable cardiac defibrillator (ICD) results in reduction in     total mortality, when compared with conventional pharmacological therapy, in patients     resuscitated from sudden cardiac death who are otherwise at very high risk of mortality from     arrhythmic causes.   "
160959|NCT00000532|"     To determine if the increase in low density lipoprotein (LDL) cholesterol at the time of     menopause could be ameliorated or prevented by an intensive dietary intervention. Also, to     prevent the increase in body weight and associated changes in insulin, glucose, blood     pressure, triglycerides, and high density lipoprotein cholesterol during the peri- to     postmenopausal period.   "
160960|NCT00000533|"     To examine the impact of a monitoring and social support intervention upon survival of     myocardial infarction patients.   "
160965|NCT00000538|"     To evaluate the effects of carefully controlled diets on lipoproteins and clotting factors in     different demographic groups.   "
160966|NCT00000539|"     To evaluate, in asymptomatic and symptomatic participants with peripheral arterial disease,     the feasibility of recruitment and adherence, efficacy and safety of HDL-C raising along with     effective control of LDL-C levels, antioxidant therapy, antithrombotic therapy, and their     combinations.   "
160967|NCT00000540|"     To test the hypothesis that implantable cardioverter defibrillator (ICD) therapy will improve     survival in coronary heart disease patients at high risk of death, especially arrhythmic     death.   "
193706|NCT00380471|"     The purpose of this study is to determine whether bath PUVA are effective in treatment of     vitiligo and what is the complication of bath PUVA in vitiligo.   "
160977|NCT00000550|"     To evaluate the impact of community educational interventions on patient delay time from     onset of symptoms and signs of an acute myocardial infarction (AMI) to arrival at a hospital     Emergency Department (ED). Also, to study the impact of community educational interventions     on use of Emergency Medical Services (EMS) and EDs, on thrombolytic therapy, and on AMI case     fatality.   "
160978|NCT00000551|"     To develop and evaluate the effectiveness of various intervention approaches, delivered in     primary health-care settings, in increasing and maintaining habitual physical activity and     cardiorespiratory fitness among sedentary men and women patients.   "
160979|NCT00000552|"     To test if early revascularization, primarily with angioplasty (PTCA) or bypass surgery     (CABG), reduced all-cause in-hospital mortality from cardiogenic shock compared to     conventional treatment, including thrombolysis.   "
160980|NCT00000553|"     To measure the effects of lipid-lowering drugs and/or antioxidant vitamins on progression or     regression of coronary heart disease as measured by quantitative angiography in patients with     low high density lipoprotein (HDL) cholesterol.   "
160981|NCT00000554|"     To evaluate innovative diagnostic methods that will improve the diagnostic reliability of     cardiovascular testing in evaluation of ischemic heart disease in women. Innovative     approaches proposed include physiologic or functional measurements such as impaired     metabolism, perfusion, or endothelial function as well as assessment of epicardial coronary     arteries by angiography. Other objectives include developing safe, accurate, and cost     effective diagnostic approaches for evaluating women with suspected ischemic heart disease,     and determining the frequency of myocardial ischemia in the absence of significant epicardial     coronary stenosis, as well as the frequency of non-ischemic or non-cardiac chest pain. A key     aspect of the WISE study is to determine whether evidence of myocardial ischemia occurs in     the absence of obstructive coronary disease.   "
160982|NCT00000555|"     To assess whether hormonal replacement therapy and/or antioxidant treatment would stabilize     or inhibit progression, and induce regression of coronary plaques. The mechanisms by which     these treatments modified atherosclerosis in women were also explored.   "
160983|NCT00000556|"     To compare two standard treatment strategies for atrial fibrillation: ventricular rate     control and anticoagulation vs. rhythm control and anticoagulation.   "
160984|NCT00000557|"     To evaluate the effect of psychosocial intervention on mortality and reinfarction in coronary     heart disease patients at high psychosocial risk.   "
160985|NCT00000558|"     To determine whether the addition of angiotensin converting enzyme (ACE) inhibitor to     standard therapy in patients with known coronary artery disease and preserved left     ventricular function will prevent cardiovascular mortality and reduce the risk of myocardial     infarction.   "
160986|NCT00000559|"     To determine the effects, in postmenopausal women, of hormone replacement therapy on     progression/regression of coronary heart disease, as measured by quantitative angiography.   "
160987|NCT00000560|"     To determine if addition of a beta-blocker to standard therapy in Class III and Class IV     heart failure patients reduced total mortality.   "
160988|NCT00000561|"     To determine if dual chamber rate-modulated pacing (DDDR) in patients with sick sinus     syndrome is superior to single chamber pacing (VVIR) with respect to subsequent frequency of     adverse clinical events such as stroke, quality of life and function, and cost effectiveness.   "
160989|NCT00000562|"     To evaluate indications for the use and efficacy of extracorporeal membrane oxygenators     (ECMO's) for the support of patients with potentially reversible acute respiratory failure.   "
160990|NCT00000563|"     To determine the effect of corticosteroids, administered 24 to 48 hours before parturition,     on the incidence of neonatal respiratory distress syndrome (RDS) and to determine whether the     therapy has any adverse short- or long-term (up to 36 months) effects on the infant.     Secondarily, to determine whether the therapy has any adverse short-term effects on the     mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as     well as total and cause-specific infant mortality rates differ between mothers who received     antenatal steroids and those who received conventional medical care.   "
160991|NCT00000564|"     To compare the efficacy of long-term use of nocturnal oxygen therapy (12 hours) with that of     continuous, low-flow oxygen therapy (24 hours) in patients with chronic hypoxic lung disease.   "
160992|NCT00000565|"     To evaluate the efficacy of long-term intermittent positive pressure breathing (IPPB)     treatment when used as an adjunct to the overall care of ambulatory outpatients with chronic     obstructive pulmonary disease. The evaluation compared the use of IPPB with use of a powered     nebulizer.   "
160993|NCT00000566|"     To evaluate the sensitivity and specificity of two major, widely used technologies,     radionuclear imaging (ventilation-perfusion scanning) and pulmonary angiography, for the     diagnosis of pulmonary embolism.   "
160994|NCT00000567|"     To compare the efficacy and safety of high frequency ventilation (HFV) with that of standard,     mechanical ventilation in premature infants of less than 2000 grams.   "
160995|NCT00000568|"     In the Lung Health Study I, to determine the effects of Special Care, compared to Usual Care,     on rate of decline in pulmonary function in a group of cigarette smokers identified as having     mild abnormalities in pulmonary function.      In the Lung Health Study III, to determine the long-term effects of smoking cessation and     continued smoking, on cardiopulmonary morbidity, mortality, and the rate of decline in the     one second forced expiratory volume (FEV1) in men and women with early chronic obstructive     lung disease who have been followed prospectively for 12 to 15 years.   "
172796|NCT00095147|"     The purpose of this clinical research study is to learn if Abatacept or Infliximab in     combination with Methotrexate demonstrate a greater reduction in disease activity over     placebo.   "
160996|NCT00000569|"     To determine if participants with chronic obstructive pulmonary disease, who were assigned to     inhaled corticosteroids had a lower rate of decline in lung function and lower incidence of     respiratory morbidity compared to participants assigned to placebo.   "
160997|NCT00000570|"     To determine if surfactant administration at birth in infants at high risk for respiratory     distress syndrome (RDS) modified the clinical course of the syndrome.   "
160998|NCT00000571|"     To test the effectiveness of ventilatory muscle rest (VMR) using home negative pressure     ventilation (NPV) in improving exercise performance, alleviating dyspnea, and improving the     quality of life in patients with severe chronic obstructive lung disease.   "
160999|NCT00000572|"     To compare conventional therapy using low frequency positive pressure ventilation with     extracorporeal CO2 removal for the treatment of adult respiratory distress syndrome (ARDS).   "
161000|NCT00000573|"     To determine if enteral nutrition support (ENS) restores normal body weight and improves     muscle strength, exercise performance, sensation of dyspnea, and quality of life in     malnourished patients with chronic obstructive pulmonary disease.   "
161001|NCT00000574|"     To determine the effects of ibuprofen on mortality, development and reversal of shock, and     adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients     with serious infection.   "
161002|NCT00000575|"     The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy     compared to bronchodilator therapy on the course of asthma, particularly on lung function and     bronchial hyperresponsiveness, and on physical and psychosocial growth and development.   "
161003|NCT00000576|"     To test if inhaled glucocorticoids, early in the course of respiratory failure in premature     infants, permit normal lung growth and differentiation, thus preventing development of     bronchopulmonary dysplasia.   "
161004|NCT00000577|"     This study will establish a network of interactive asthma clinical research groups to     evaluate current therapies, new therapies, and management strategies for adult asthma.   "
161005|NCT00000578|"     To conduct a collaborative program of research on asthma and pregnancy consisting of two     studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate     relationships between asthma severity and treatment programs and perinatal outcome, and the     Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled     beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both     studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group     of participating obstetric centers supported by the National Institute of Child Health and     Human Development. Studies were co-funded by the NHLBI.   "
161006|NCT00000579|"     The purposes of this study are to assess rapidly innovative treatment methods in patients     with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS     and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish     and maintain the required infrastructure to perform multiple therapeutic trials that may     involve investigational drugs, approved agents not currently used for treatment of ARDS, or     treatments currently used but whose efficacy has not been well documented.   "
161007|NCT00000580|"     To evaluate whether hepatitis B immune globulin with a high level of antibody against the     hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis     B virus, the single most important route of hepatitis spread in the entire Third World.   "
161008|NCT00000581|"     To evaluate granulocyte transfusion therapy with respect to its prophylactic and therapeutic     effectiveness to prevent and aid recovery from infection. The study trials were conducted     simultaneously.   "
161009|NCT00000582|"     To test the efficacy of prothrombin complex concentrates (Factor IX) in the treatment of     hemophiliac patients who had inhibitors to Factor VIII.   "
161010|NCT00000583|"     To determine the efficacy of a hepatitis vaccine in preventing hepatitis B.   "
161011|NCT00000584|"     To evaluate the capacity of intravenously administered cytomegalovirus (CMV)-immune globin     (CMVIG) to immunize high risk premature infants against CMV infections.   "
161012|NCT00000585|"     To determine whether the regular daily administration of oral penicillin would reduce the     incidence of documented infection due to Streptococcus pneumoniae in children with sickle     cell anemia.   "
161013|NCT00000586|"     To assess the efficacy and safety of orally administered hydroxyurea in the treatment of     painful crises in patients with sickle cell anemia.   "
161014|NCT00000587|"     To determine whether administration of human recombinant erythropoietin (REPO) improved or     eliminated the anemia seen in human immunodeficiency virus (HIV) infected patients after     therapy with zidovudine (ZDV).   "
161015|NCT00000588|"     To demonstrate the safety and effectiveness of orally-administered pyridoxal isonicotinoyl     hydrazone (PIH) for the chronic treatment of iron overload.   "
161016|NCT00000589|"     To determine the best, clinically useful procedure to prevent or minimize platelet     alloimmunization as a cause of refractoriness to platelet transfusion in patients undergoing     marrow ablative chemotherapy for acute myelogenous leukemia.   "
161017|NCT00000590|"     To determine if HIV hyperimmune globulin (HIVIG) given to HIV-positive pregnant women during     the second and third trimester of pregnancy reduced the likelihood of maternal-fetal HIV     transmission. Conducted in collaboration with the National Institute of Child Health and     Human Development and the National Institute of Allergy and Infectious Diseases. The trial     was Pediatric ACTG Protocol 185.   "
161018|NCT00000591|"     To determine if a reduction in morbidity and mortality from acute and chronic graft versus     host disease (GvHD) can be achieved through use of T-cell depletion techniques without a     counterbalancing increase in relapse of leukemia in patients receiving an unrelated donor     marrow transplant.   "
161019|NCT00000592|"     To reduce episodes of first time stroke by 75 percent in children with sickle cell anemia by     the administration of prophylactic transfusion therapy.   "
161020|NCT00000593|"     The purpose of the trial was to determine if transfusion of allogeneic blood to HIV-1     infected persons led to immune activation and consequent induction of HIV-1 or /or     Cytomegalovirus (CMV) replication, and whether this adversely affected clinical prognosis.   "
174277|NCT00122226|"     This is a randomized prospective study into metabolic adverse events during different types     of initial antiretroviral therapy in HIV-1-infected men.   "
161021|NCT00000594|"     To determine whether lowering of cholesterol with cholestyramine in a population with Type II     hyperlipidemia led to a decreased rate of progression (a regression of coronary artery     disease) as demonstrated by death, myocardial infarction, or progression of disease on     angiography.   "
161022|NCT00000595|"     To determine whether deferoxamine prevented the complications of transfusional iron overload.   "
161023|NCT00000596|"     To determine the effects of cyclophosphamide compared with prednisone, dapsone, or high-dose     intermittent 'pulse' therapy with methylprednisolone in patients with idiopathic pulmonary     fibrosis. Also, to evaluate the use of intermittent, short-term, high-dose intravenous     corticosteroids in patients with sarcoidosis. There were actually four separate clinical     trials.   "
161024|NCT00000597|"     To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with     aplastic anemia and related bone marrow failure diseases.   "
161025|NCT00000598|"     To determine the effect in men and postmenopausal women with elevated LDL-cholesterol and low     HDL-cholesterol of an exercise regimen with or without the National Cholesterol Education     Program (NCEP) Step Two diet compared to usual care control group on HDL- and     LDL-cholesterol.   "
161026|NCT00000599|"     To determine whether combined therapy with the lipid lowering agents colestipol hydrochloride     plus niacin would produce significant change in coronary, carotid, and femoral artery     atherosclerosis and coronary bypass graft lesions as determined by angiography. Also, to     determine possible correlations between lesion changes and plasma lipid and lipoprotein     cholesterol levels and to explore interrelationships of atherosclerosis change in femoral,     coronary, and carotid arteries.   "
161027|NCT00000600|"     This study will evaluate the effects of vitamin E supplementation in retarding the     progression of common carotid artery intima-media thickening in African Americans.   "
161028|NCT00000601|"     To determine if estrogen therapy in postmenopausal women with unstable angina reduces the     incidence of ischemic episodes.   "
161029|NCT00000602|"     To determine whether hydroxyurea prevents the onset of chronic end organ damage in young     children with sickle cell anemia.   "
161030|NCT00000603|"     To evaluate if HLA-mismatched, unrelated-donor umbilical cord blood stem and progenitor cell     units (UCBU) offered a clinically acceptable alternative to matched unrelated-donor     allogeneic bone marrow for transplantation with 180-day disease free survival as the     endpoint. HLA typing was performed using DNA-base high resolution methods to determine HLA     alleles. Patients with true HLA 3/6 and 4/6 matches were evaluated. In addition, a separate     study in adults addressed the problem of limited cell dose and engraftment failure. The study     was not planned as a randomized comparative clinical trial. Instead, it is a phase II/III     efficacy study.   "
161031|NCT00000604|"     To compare three accepted modes of myocardial preservation, warm, tepid, and cold blood     cardioplegia, coinciding with normothermic (37 degrees centigrade), tepid (32 degrees     centigrade) and hypothermic (8 to 10 degrees centigrade) cardiopulmonary bypass (CPB) to     define differences in neurologic function in coronary artery bypass graft (CABG) patients.   "
161032|NCT00000605|"     To determine if postmenopausal hormone replacement therapy in women following coronary bypass     surgery would reduce the occurrence of graft occlusion and delay the development of graft     atherosclerosis.   "
161033|NCT00000606|"     To evaluate the long term efficacy, morbidity and mortality associated with medical therapy     with lung volume reduction surgery (LVRS) as compared to medical therapy alone and to define     patient selection criteria. The trial, conducted in conjunction with a patient registry, is     supported by the NHLBI, the Centers for Medicare and Medicaid Services (CMS), and the Agency     for Healthcare Research and Quality (AHRQ).   "
161034|NCT00000607|"     To conduct a randomized, unblinded clinical trial comparing the left ventricular assist     device (LVAD) with maximum medical management in patients with end-stage heart failure who     were not candidates for heart transplantation.   "
161035|NCT00000608|"     To compare the effects of three levels of dietary sodium and two patterns of diet (a control     diet and an intervention diet high in fruits, vegetables, and low fat dairy products and low     in fat) on blood pressure in individuals with higher than optimal blood pressure or with     Stage 1 hypertension.. DASH - Sodium built on and extended the results of the NHLBI-initiated     Dietary Approaches to Stop Hypertension (DASH) study.   "
161036|NCT00000609|"     To compare conventional treatment of congestive heart failure (CHF) with two experimental     interventions: amiodarone and an implantable cardioverter-defibrillator (ICD).   "
161037|NCT00000610|"     To determine whether early intravenous magnesium treatment of patients with suspected acute     myocardial infarction reduces mortality.   "
161038|NCT00000611|"     To address cardiovascular disease, cancer, and osteoporosis, the most common causes of death,     disability, and impaired quality of life in postmenopausal women. The three major components     of the WHI are: a randomized controlled clinical trial of hormone replacement therapy (HRT),     dietary modification (DM), and calcium/vitamin D supplementation (CaD); an observational     study (OS); and a community prevention study (CPS). On October 1, 1997, administration of the     WHI was transferred to the NHLBI where it is conducted as a consortium effort led by the     NHLBI in cooperation with the National Institute of Arthritis and Musculoskeletal and Skin     Diseases (NIAMS), the National Cancer Institute (NCI), and the National Institute on Aging     (NIA).   "
161039|NCT00000612|"     To conduct a three-armed trial assessing the effect of soy phytoestrogens on menopausal     complaints, plasma lipids and lipoproteins, vaginal bleeding and endometrial proliferation,     and health related quality of life.   "
161040|NCT00000613|"     To determine the acceptability and benefits of use of a dietary supplement of the     phytoestrogen, genistein, versus placebo on heart disease risk factors, bone density, and     psychosocial outcomes in postmenopausal women.   "
161041|NCT00000614|"     A multicenter randomized, double blind placebo controlled trial to determine the efficacy of     long-term, low dose warfarin in the secondary prevention of venous thromboembolism.   "
161042|NCT00000615|"     To develop and test interventions to prevent obesity by decreasing weight gain during the     high-risk transitional period from pre-puberty to puberty in African-American girls who are     at high risk for developing obesity.   "
173296|NCT00110396|"     The primary objective of the study is to compare the immunogenicity of the new fetal bovine     serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.   "
161043|NCT00000616|"     To compare the effectiveness of advice versus two multicomponent lifestyle interventions to     control blood pressure in participants with Stage 1 hypertension or higher than optimal blood     pressure.   "
161044|NCT00000617|"     To determine whether treatment with azithromycin decreases the rate of coronary heart disease     events among patients with stable documented coronary artery disease.   "
161045|NCT00000619|"     To compare the efficacy of Pulmonary Artery Catheterization (PAC)-directed treatment strategy     to a non-invasive treatment strategy on morbidity and mortality in patients with severe,     class IV New York Heart Association (NYHA) congestive heart failure. A secondary objective     was to determine costs and resource utilization of PAC-directed treatment strategy compared     to non-invasive treatment strategy.   "
161046|NCT00000620|"     The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or     cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic     control, intensive blood pressure control, and multiple lipid management.   "
161047|NCT00000621|"     To conduct feasibility studies on the use of retinoids in the treatment of emphysema.     Specific objectives are to identify optimal patient populations, retinoids, doses, dosing     schedules, routes of administration, and outcome measures preparatory to conducting a larger,     controlled, clinical trial on the efficacy of retinoid therapy in the management of     emphysema.   "
161048|NCT00000622|"     The purpose of this study is to evaluate current and novel therapies and management     strategies for children with asthma. The emphasis is on clinical trials that help identify     optimal therapy for children with different asthma phenotypes, genotypes, and ethnic     backgrounds and children at different developmental stages.   "
161049|NCT00000623|"     The purpose of the TCRN is to accelerate research in the management of thalassemia,     standardize existing treatments, and evaluate new ones in a network of clinical centers in     North America. The emphasis will be on clinical trials that help identify optimal therapy.     Therapeutic trials may involve investigational drugs, drugs already approved but not     currently used, and drugs currently used.   "
161050|NCT00000625|"     To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT     plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected     patients with CD4 counts of 200-500 cells/mm3.   "
161051|NCT00000626|"     Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin /     vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating     factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe     the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with     Hodgkin's disease.      Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year     study period; to observe the incidence of bacterial and opportunistic infections in     HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of     life of patients receiving this regimen.      Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by     chemotherapy, allowing more timely administration of chemotherapy and improved response.   "
161052|NCT00000627|"     To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2)     maintenance therapy to prevent relapse of histoplasmosis.      Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a     triazole antifungal agent that has been used successfully in the treatment of experimental     histoplasmosis in animals, but has not been completely evaluated in patients for this use. It     has been approved by the Food and Drug Administration for certain other fungal infections.     Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a     pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.   "
161053|NCT00000628|"     Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine     (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with     L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a     study of the antiviral activity of L-697,661.      L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and     growth) in cell culture. It works together with AZT against HIV.   "
161054|NCT00000629|"     Primary objective: To study the pharmacokinetic interaction between zidovudine (AZT) and     valproic acid in asymptomatic HIV-infected patients, characterizing AZT's oral     bioavailability, plasma elimination half-time, plasma levels, and urinary excretion of AZT,     5'-O-glucuronide (GAZT), and 3'-amino-3'-deoxythymidine (AMT). Secondary objective: To     establish the safety of short-term administration of AZT and valproic acid in combination     with regard to hematologic parameters and liver function in asymptomatic HIV-infected     patients.      Preliminary studies using human liver tissue have shown that valproic acid inhibits the     metabolic inactivation of zidovudine (AZT), which may prolong the plasma half-life of AZT and     thus prolong the duration of the drug's effects in the body.   "
161055|NCT00000630|"     To determine if priming (giving the first vaccination) with a vaccinia recombinant (HIVAC-1e)     provides a significant advantage in immunogenicity (production of antibodies) compared to     priming with a soluble recombinant protein (gp160); to learn more about the safety of the     combination use of the two HIV envelope vaccines utilized in the study.      Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines,     HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include:     Does combination vaccination result in a synergistic (added) response not predicted by just     the addition of a second vaccination, and does this synergism depend on the unique priming     effect of a vaccinia recombinant, or will any combination do?   "
161056|NCT00000631|"     Primary: To determine whether additional boosting with soluble recombinant gp160 vaccine     (VaxSyn) after priming with a vaccinia-HIV envelope recombinant (HIVAC-1e) provides a     significant advantage in the degree and duration of immunogenicity. Secondary: To learn more     about the safety of the combination use of the two HIV envelope vaccines in the study (VaxSyn     and HIVAC-1e).      Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have     persisted in most recipients for 6 months after boosting, and responses seem significantly     higher and more persistent than responses achieved by just two doses of soluble protein     vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited     cohort of volunteers whether additional boosting with soluble recombinant gp160 results in     increased immunogenicity of longer duration.   "
161057|NCT00000632|"     To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0,     30, 180, and 365.      Preliminary immunologic data from protocol VEU 005B show evidence of the development of     functional antibodies in the form of increased peptide binding and development of     neutralizing antibodies. Evaluation of an antigen dose having potentially greater     immunogenicity is therefore of particular interest.   "
161075|NCT00000650|"     To determine, in HIV-infected patients, the magnitude and duration of the biological effects     of ditiocarb sodium (sodium diethyldithiocarbamate; DTC) that may be relevant to treatment of     HIV infection.      DTC has been studied in previous clinical trials in HIV-infected patients with the suggestion     of delay in disease progression to AIDS and improvement in CD4 counts while on the drug.   "
161175|NCT00000145|"     To assess the clinical course, prognosis, and risk factors of age-related macular     degeneration (AMD) and cataract.      To evaluate, in randomized clinical trials, the effects of pharmacologic doses of (1)     antioxidants and zinc on the progression of AMD and (2) antioxidants on the development and     progression of lens opacities.   "
161058|NCT00000633|"     To determine the safety and immunogenicity of vaccinia-derived HIV-1 recombinant envelope     glycoprotein (gp160) in asymptomatic HIV-infected adult volunteers. To compare safety and     immunogenicity of two different schedules of gp160 administration. To examine the effects of     gp160 and hepatitis B vaccine (Engerix-B) on various markers of viral load and on selected     immune parameters.      Potentiation of a patient's immune response to HIV might possibly prolong the period of     clinical latency and protect the patient indefinitely. Preliminary results from a study of     Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that     the vaccine is safe and produces antibodies against the virus. Because another previous study     failed to demonstrate a specific anti-HIV response in patients injected with a recombinant     vaccinia virus containing HIV-1 genes, this study is also testing the immunotherapeutic role     of other immunizations (such as hepatitis B vaccination) that would be expected to induce a     nonspecific immune response in HIV-infected persons.   "
161059|NCT00000634|"     To generate initial information on the pharmacokinetics (blood levels) and dose     proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess     the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children;     and to confirm that the single doses that achieve certain plasma levels in adults achieve     similar levels in HIV-infected children.      Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction)     of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus     that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious     adverse effects.   "
161060|NCT00000635|"     To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in     treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus     ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV     infection in patients with AIDS is often associated with skin sores and frequent recurrences.     Treatment with the drug acyclovir results in healing for most patients, but repeated     treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens,     other treatments need to be used. Trifluridine is an antiviral drug that is used for the     treatment of Herpes infections that occur in the eye. This study attempts to determine if     trifluridine is useful for treating HSV sores that have not healed after treatment with     acyclovir.   "
161061|NCT00000636|"     To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide     versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in     patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb).      Current guidelines recommend 6 to 12 months of treatment with INH for purified protein     derivative (PPD)-positive individuals. Problems with this treatment include compliance,     adverse reaction, and the possibility of not preventing disease due to INH-resistant     organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more     effective than longer courses of INH. A two-month prevention course should help to increase     compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome     problems with drug resistance.   "
161062|NCT00000637|"     To compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI)     and compared to the combination of AZT and ddI as determined by survival and disease     progression. To compare the relative safety and tolerance of AZT versus ddI versus AZT plus     ddI in symptomatic HIV infected children; to compare the virological and immunological     parameters in the three treatment groups. AZT has been shown to delay the progression of AIDS     in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect.     Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment,     but later have progression of the disease. Thus, new drug treatments are needed. Studies of     ddI in adults and children indicate some effectiveness of the drug. A direct comparison of     AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT     plus ddI) may give added therapeutic benefit to children.   "
161063|NCT00000638|"     To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH)     versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation     tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium     tuberculosis.      Current guidelines from the American Thoracic Society and the Centers for Disease Control     recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals.     Although the effectiveness of this treatment is not known for HIV-infected individuals,     several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to     80 percent effectiveness. Problems with this treatment include compliance, adverse reaction,     and the possibility of not preventing disease due to tuberculosis organisms being resistant     to INH. A two-month preventive treatment plan should help in increasing compliance. In     addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug     resistance. If this study shows equal or greater effectiveness of the two-month rifampin /     pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both     HIV-positive and HIV-negative individuals.   "
161151|NCT00000120|"     To compare the effectiveness of silver nitrate drops, erythromycin ointment, or no medication     in preventing neonatal conjunctivitis caused by Chlamydia trachomatis and other eye     infections.      To compare side effects of the two prophylactic agents.   "
161064|NCT00000639|"     To evaluate the effectiveness and safety of amphotericin B plus flucytosine     (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal     meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole     versus itraconazole.      At least 10 percent of patients with a low CD4 count and HIV infection will develop     meningitis due to Cryptococcus neoformans. More effective treatments than the standard     therapy need to be explored.   "
161065|NCT00000640|"     To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis     carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a     standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance     of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per     09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments     in patients who are intolerant to SMX/TMP.      The type of treatment being studied has the advantages of wide applicability throughout the     world (including developing countries) and low cost. An oral treatment is more accessible to     patients than drugs given by injection or by inhalation.   "
161176|NCT00000146|"     To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis.      To determine the natural history of vision in patients who suffer optic neuritis.      To identify risk factors for the development of multiple sclerosis in patients with optic     neuritis.   "
161066|NCT00000641|"     To compare the effectiveness and toxicity of two combination drug treatment programs for the     treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per     03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with     either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is     the most common systemic bacterial infection complicating AIDS in the United States. The     prognosis of patients with disseminated M. avium is extremely poor, particularly when it     follows other opportunistic infections or is associated with anemia. Test tube studies and     clinical data indicate that the best treatment program may include clofazimine, ethambutol, a     rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin     is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin.     Its role in treatment programs is a key issue because of toxicity and because it must be     administered parenterally (by injection or intravenously).   "
161067|NCT00000642|"     Part 1: To determine both the safety, tolerance, and pharmacokinetic profile (blood levels)     of recombinant CD4 immunoglobulin G (rCD4-IgG) by intravenous bolus administration (given     through the vein) in women with HIV infection who are in their third trimester (last three     months of pregnancy). To determine the safety of maternal/fetal transfer of rCD4-IgG in     infants born to mothers entered into the study. To obtain a preliminary indication of the     antiviral and immunologic effects of rCD4-IgG in HIV seropositive pregnant women and their     newborns.      AMENDED: Part 2: To determine the safety profile of rCD4-IgG in HIV-1-infected women at the     onset of labor and in their newborns. To determine the extent of placental transfer of     rCD4-IgG when administered to the mother at onset of labor. To determine the pharmacokinetics     of rCD4-IgG in newborns. To obtain preliminary evidence of the ability of rCD4-IgG to prevent     intrapartum transmission of HIV-1 from mother to fetus.      An agent that can prevent HIV infection is desirable for those at risk of infection as well     as in the pregnant female and newborn populations. Such an agent may help prevent the     progression of the disease in infants and children in early stages of infections. In theory,     rCD4-IgG has antiviral effects.   "
161068|NCT00000643|"     To evaluate the effectiveness of pyrimethamine (given with leucovorin calcium versus placebo     (an inactive substance) for the primary prophylaxis (prevention) of cerebral toxoplasmosis in     HIV-infected patients.      Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in     the course of AIDS. The mortality (death) rate is estimated to be greater than 50 percent.     Pyrimethamine is a drug that appears promising for the primary prevention of cerebral     toxoplasmosis in HIV-infected patients.   "
161069|NCT00000644|"     This study is designed to evaluate the efficacy and safety of clarithromycin given orally at     1 of 3 doses to treat disseminated Mycobacterium avium complex infections (MAC) in patients     with AIDS.      Mycobacterium avium complex (MAC) is thought to be the most common disseminated bacterial     opportunistic infection in AIDS, with clinical prevalence estimates ranging from 15 to 50     percent of all AIDS patients. Clarithromycin, a new macrolide antimicrobial agent, has     demonstrated activity against MAC both in the laboratory and in animals. Clinical experience     treating AIDS patients with clarithromycin for disseminated MAC is limited. However, early     studies have indicated few adverse effects and some improvement in clinical symptoms scores     and Karnofsky performance scores over placebo treated patients.   "
161070|NCT00000645|"     To determine the maximum tolerated dose (MTD) of hypericin, to define the types of toxicities     that may be observed, and to determine what doses of the drug are associated with     improvements in virological and immunological surrogate markers of HIV infection. To     determine the bioavailability of synthetic hypericin given in 2 percent benzyl alcohol     solution.      Hypericin is unlike other drugs presently being used to treat AIDS patients. Hypericin shows     anti-HIV activity in test tube experiments.   "
161071|NCT00000646|"     To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS     patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease     such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of     zidovudine (AZT) activity.   "
161072|NCT00000647|"     To restore immunologic function and virus-free state in HIV-infected patients. Based on     previous studies showing temporary improvement in immune function in HIV-infected patients     using peripheral lymphocyte transfers and bone marrow transplantation, and based on studies     documenting the antiretroviral effects of zidovudine (AZT) and interferon-alfa (IFN-A) as     well as the preliminary test tube and patient studies suggesting anti-HIV effects of     recombinant CD4-IgG, we propose to treat HIV-infected patients using combination     antiretroviral therapy with transplantation of bone marrow and peripheral lymphocytes from     previously immunized donors in an attempt to restore immunologic function and a virus-free     state.   "
161515|NCT00000502|"     To assess the benefits of a new method of cardiopulmonary resuscitation, SC-V CPR     (simultaneous compression and ventilation CPR) in terms of short and long-term survival and     lessened cerebral dysfunction.   "
161073|NCT00000648|"     To provide information on the response of HIV infected, neurosyphilis patients to the     currently recommended treatment for neurosyphilis; to determine whether possible co-infection     with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the     usefulness of an alternative treatment which, if effective, would permit outpatient treatment     for neurosyphilis that until now required prolonged hospitalization.      Studies suggest that syphilis treatment failures may be more common in HIV infected patients     than in patients without HIV infection and that treatment failures occur due to and/or are     displayed as central nervous system (CNS) involvement. Very little is known about the best     treatment course for neurosyphilis in patients who are also infected with HIV.   "
161074|NCT00000649|"     To assess the safety and tolerance of multiple oral doses of nevirapine in combination with     zidovudine (AZT); to get information on the pharmacokinetics (blood levels) and dose     proportionality of nevirapine/AZT with multiple dosing; to characterize the pattern of     virological activity in vivo (in humans) of nevirapine in combination with AZT; to determine     whether development of resistance to either drug is slowed by the use of the combination.      Drugs now used in treatment for patients with AIDS show some toxicity which limits their     usefulness. In addition, with long-term treatment with AZT, there is evidence of virus     resistance to the drug. Compounds that are more effective and less toxic than those in     present use would be beneficial, especially if they are active against AZT-resistant viruses.     Nevirapine has shown in vitro (test tube studies) activity in inhibiting HIV replication     (reproduction). In vitro studies have shown that nevirapine and AZT work together to inhibit     HIV replication.   "
161076|NCT00000651|"     To evaluate the safety of zalcitabine (dideoxycytidine; ddC) alone and in combination with     zidovudine (AZT) versus AZT alone when administered to asymptomatic patients with a CD4 count     = or < 200 cells/mm3 and symptomatic patients with a CD4 count = or < 300 cells/mm3. To     compare the effectiveness of ddC alone and in combination with AZT versus AZT alone.      ddC has been shown to demonstrate an antiviral effect. AZT has been shown to significantly     decrease mortality and reduce the frequency of opportunistic infections in patients with AIDS     or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and     patients progress with more opportunistic infections and higher mortality rates. Because of     the demonstrated antiviral activity, absence of hematologic toxicity, and lack of cross     tolerance in laboratory studies of ddC, a study to investigate the long-term effectiveness of     ddC in patients with HIV infection who have received AZT therapy is warranted.   "
161077|NCT00000652|"     To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine     (ddI) in children with HIV infection.      New approaches to using available agents may provide increased or improved treatment options     for AIDS. Combination therapy is expected to play a major role in improving survival and     quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most     extensively evaluated and for which the evidence for antiretroviral effectiveness is     strongest.   "
161078|NCT00000653|"     To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two     doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with     symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT )     (development of toxicity during prolonged AZT therapy), demonstrated disease progression     after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months     of AZT therapy.      As useful as AZT appears to be in the treatment of patients infected with HIV, it is     associated with significant toxicity in some patients, and it does not prevent ultimate     progression to AIDS and eventual mortality. Thus, there is a clear need for new     antiretroviral drugs, and ddC is one such promising agent.   "
161079|NCT00000654|"     To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4     different dose levels. To determine the peak and trough blood levels of FIAU and its     metabolites during two weeks of oral dosing with FIAU.      The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are     highly and specifically active compounds in vitro against several herpes group viruses,     particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and     cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary     metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is     anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as     FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally,     is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral     doses are expected to provide concentrations of FIAU exceeding the in vitro minimum     inhibitory concentration for nearly all the herpes group viruses.   "
161080|NCT00000655|"     To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis     agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP)     in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and     SMX/TMP in AIDS patients with an acute episode of PCP.      Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine     isetionate. Although both treatments are equally effective, side effects prevent completion     of therapy in 11-55 percent of patients.   "
161081|NCT00000656|"     To assess the safety and to evaluate the anti-HIV effect of low-, moderate-, and high-dose     schedules of zidovudine (AZT) plus didanosine (ddI) versus ddI alone in asymptomatic     HIV-infected patients. Because of the failure with long-term (more than 1 year) use of,     frequency of toxicity from, and drug resistance to AZT, drug combinations need to be     developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the     development of resistance, while providing at least the same effectiveness.   "
161114|NCT00000689|"     To determine the toxicity and effectiveness of adding sargramostim (recombinant     granulocyte-macrophage colony stimulating factor; GM-CSF) to a standard chemotherapy drug     combination (methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and     dexamethasone) known as mBACOD in the treatment of non-Hodgkin's lymphoma in patients who are     infected with HIV.      Treatment of patients with AIDS-associated lymphoma is achieving inferior results when     compared with outcomes for non-AIDS patients. Treatment with mBACOD has been promising, but     the toxicity is very high. Patients treated with mBACOD have very low white blood cell     counts. GM-CSF has increased the number of white blood cells in animal studies and     preliminary human studies. It is hoped that including GM-CSF among the drugs given to     lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD.   "
161082|NCT00000657|"     To compare the safety and effectiveness of orally administered didanosine (ddI) with high     dose orally administered zidovudine (AZT) in patients who develop or exhibit progression of     the AIDS dementia complex (ADC) and who have not previously been intolerant to AZT at doses     of up to 1000 mg/day.      HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system. ADC     may be caused by some action of the AIDS virus on the nervous system, although similar     problems can be caused by other infections because the AIDS virus lowers the body's ability     to fight other infections. It is important to determine whether symptoms are due to ADC or to     some other infection since treatment varies for different conditions. AZT has been shown to     be beneficial to people with ADC although its effectiveness has only been studied in a small     number of patients. Studies suggest that higher doses of AZT are more likely to be effective     than standard doses in improving symptoms of ADC.   "
161083|NCT00000658|"     To determine the impact of dose intensity on tumor response and survival in patients with     HIV-associated non-Hodgkin's lymphoma (NHL).      HIV-infected patients are at increased risk for developing intermediate and high-grade NHL.     While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency     is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been     disappointing. Treatment is frequently complicated by the occurrence of multiple     opportunistic infections, as well as the presence of poor bone marrow reserve, making the     administration of standard doses of chemotherapy difficult. A recent study was completed     using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin,     vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate     was observed in patients treated with this combination of chemotherapeutic agents, with a     number of durable remissions and reduced toxicity when compared to previous experience with     more standard treatments. A subsequent study showed similar effectiveness using a lower dose     of methotrexate administered on day 15. It is hoped that the use of sargramostim     (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function     and allow for administration of a higher dose of chemotherapy.   "
161177|NCT00000147|"     To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis.      To determine the natural history of vision in patients who suffer optic neuritis.      To identify risk factors for the development of multiple sclerosis in patients with optic     neuritis.   "
161084|NCT00000659|"     Part 1A: To find the dose of zidovudine (AZT) that causes less than a 50 percent drop in     HIV-1 p24 antigen levels in patients with AIDS and advanced AIDS related complex (ARC); to     determine the pharmacokinetics (blood levels) of rsCD4 administered in combination with AZT.     Parts 1B and 2: To test for additive or synergistic activity between rsCD4 and AZT as judged     by falls in HIV-1 p24 antigen levels; and to evaluate the safety of rsCD4 and AZT in patients     with AIDS and advanced ARC.      AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without     toxicity. The most clinically significant toxicity is dose related inhibition of bone marrow     function. Furthermore, HIV-1 isolates from patients treated for more than 6 months with AZT     have now been found which appear to have reduced sensitivity to AZT. The incidence of     toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability     to administer AZT long-term to patients with AIDS and advanced ARC. Recombinant soluble CD4     (rCD4) has shown antiretroviral effects and has been shown to be safe when given to AIDS and     ARC patients either as a single agent or in combination with AZT.   "
161085|NCT00000660|"     To define the toxicity and maximum-tolerated dose of weekly oral etoposide (VP-16) in     patients with AIDS-related Kaposi's sarcoma; to determine the clinical pharmacology of orally     administered VP-16 in AIDS patients. A secondary objective is to obtain preliminary data for     determining the effect of oral VP-16 on Kaposi's sarcoma.      VP-16 is an antitumor agent. Previous problems with VP-16 include the route of administration     and the toxicities. VP-16 has been given intravenously for 3 consecutive days in a 21-day     cycle for lung cancer and testicular cancer. VP-16 has also been used in lymphoma therapy.     Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid     the pain, inconvenience, and potential complications associated with medications administered     intravenously. The relative ease of outpatient administration and the potentially significant     antitumor activity of oral VP-16 motivates this study. The possibility of weekly drug     administration is the other focus of this study.   "
161086|NCT00000661|"     To determine if a pharmacokinetic (blood level) interaction exists between zidovudine (AZT)     and oxazepam in the HIV-infected patient. Benzodiazepines (such as oxazepam) are among the     most frequently prescribed class of drugs and are commonly used therapeutically for patients     with chronic disease. This study is important because of the potential for toxicity resulting     from a reaction between AZT and benzodiazepines and the likelihood of frequent use of the     combination of these drugs in patients with HIV infection.   "
161087|NCT00000662|"     To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who     are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to     monitor adverse effects of AZT.      Previous studies with pediatric patients have shown improvements in clinical, immunologic,     and virologic parameters with administration of AZT.   "
161088|NCT00000663|"     To determine the safety profile, assess pharmacokinetic properties (blood levels), and obtain     preliminary indication of the antiviral and immunologic effects of recombinant CD4     immunoglobulin G (CD4-IgG).      CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has     antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC)     have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or     subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been     observed to date.   "
161089|NCT00000664|"     To determine the safety of polyethylene glycolated IL-2 (PEG IL2) administered weekly or     biweekly (per amendment) in a setting of oral zidovudine (AZT). To determine the effect of     PEG IL2 in combination with AZT on parameters assessing the immune system as well as HIV     virus and antibody titers. To evaluate a chronic dosing study phase offered to patients who     complete the initial 25-week regimen.      Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating     viral replication (reproduction and growth). A main thrust of current treatment is the     combination of antiviral drugs that may be more effective when combined than when each is     used alone.   "
161090|NCT00000665|"     To evaluate the relative effectiveness and safety of foscarnet versus ganciclovir for the     treatment of cytomegalovirus (CMV) retinitis in people with AIDS; to evaluate the relative     effect on survival of the use of these two anti-CMV agents in the treatment of CMV retinitis;     to compare the relative benefits of immediate treatment with foscarnet or ganciclovir versus     deferral of treatment for CMV retinitis limited to less than 25 percent of zones 2 and 3.      CMV retinitis is a common opportunistic infection in patients with AIDS. Ganciclovir is     currently the only drug approved for treatment of CMV retinitis in immunocompromised     patients. Ganciclovir suppresses CMV infections, and relapse occurs in virtually all AIDS     patients when ganciclovir is discontinued. Because of their similar hematologic (blood)     toxicities, the simultaneous use of ganciclovir and zidovudine (AZT) is not recommended. More     recently the drug foscarnet has become available for investigational use. Studies so far     indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients, and that     relapse occurs in virtually all patients when the drug is discontinued. The relative     effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV     infections is unknown. Further, the long-term effects of foscarnet or ganciclovir on CMV     retinitis, survival, and morbidity are unknown. There is also no definitive information on     the relative effectiveness and safety of deferred versus immediate treatment for CMV     retinitis confined to zones 2 and 3.   "
161091|NCT00000666|"     To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in     individuals who are coinfected with HIV and latent Toxoplasma gondii.      Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard     treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine.     Continuous treatment is necessary to prevent recurrence of the disease, but constant use of     pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be     effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates     pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91     amendment, clindamycin arm was discontinued).   "
161178|NCT00000148|"     To assess the long-range outcomes of sequences of interventions involving trabeculectomy and     argon laser trabeculoplasty in eyes that have failed initial medical treatment for glaucoma.   "
161179|NCT00000149|"     To compare the long-term effect of treating newly diagnosed open-angle glaucoma with standard     medical treatment versus filtration surgery.   "
161092|NCT00000667|"     To determine the safety of intradermal gp160 in HIV seropositive individuals who are     asymptomatic and have a relatively intact immune system. To determine whether there is     evidence of a delayed-type hypersensitivity (DTH) response (a positive skin test) in these     patients, and also the dose of gp160 that elicits a delayed-type hypersensitivity (DTH)     response. Early immunity to HIV may play an important role in the long interval between virus     infection and the onset of clinical disease. Immune responses have been demonstrated in     HIV-infected individuals within weeks to months of infection. Although none of these     responses has been shown to be protective, it is possible that boosting anti-HIV immune     responses through immunization may slow the progression of HIV infection. DTH responses to     HIV-derived recombinant envelope glycoprotein could provide a means of measuring an important     immune function in infected patients, and serve as an easily measured surrogate marker of     cellular immunity. In addition to eliciting local, cutaneous DTH responses, intradermal     inoculation of skin test antigens may be immunogenic, resulting in new antibody production     and cellular immune responses. This study allows direct comparison of gp160 administered     intradermally with alum-adjuvanted intramuscular preparation with respect to immunogenicity     in HIV seropositive patients.   "
161093|NCT00000668|"     To determine the pharmacokinetics (blood levels) of three dose treatment plans of oral     ganciclovir during a 28-day dosing period. Other purposes of the study are to determine in a     population of HIV seropositive persons with cytomegalovirus (CMV) viremia, the safety,     tolerance, and patient acceptability of oral ganciclovir given for 28 days, to collect     preliminary laboratory evidence for antiviral activity and effectiveness of three dose     regimens of oral ganciclovir based on blood and urine cultures of CMV, and to relate     antiviral activity to dosage and to serum ganciclovir levels.      CMV retinitis is an important sight-threatening opportunistic infection which affects about     10 to 15 percent of people with AIDS. A previous study has shown that treatment with     ganciclovir resulted in a significant delay in time to first retinitis progression compared     to untreated controls. More studies are warranted to evaluate effects at different doses.   "
161094|NCT00000669|"     To determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxyinosine (ddI), given     orally and intravenously, in infants and children with AIDS. The study also measures     bloodstream and cerebrospinal fluid (CSF) levels of the administered drug, and provides a     preliminary assessment of the effectiveness of ddI on HIV replication.      AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term     dosing data in adults, the dosing period will be extended to 104 weeks. Original design:     Information presently available indicates that ddI has high antiviral activity with less     apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS).   "
161095|NCT00000670|"     To evaluate the interaction of probenecid with zidovudine (AZT). Because AZT is eliminated     quickly from the body, it must be taken frequently. A previous study showed that probenecid     slowed the elimination of AZT without side effects, but that study lasted only 5 days. This     study is to see whether this effect continues for 1 month and whether the continuation of     probenecid and AZT is free of side effects over 1 month.   "
161096|NCT00000671|"     To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in     patients with AIDS or advanced AIDS-related complex (ARC) who have tolerated AZT therapy for     12 months or longer. Per amendment, asymptomatic patients with CD4 counts less than 200     cells/mm3 are eligible.      AZT is effective in reducing mortality in patients with AIDS who receive the drug after the     first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC.     However, AZT therapy has been associated with significant toxicities. In addition, the     effectiveness of AZT appears to decrease during the second and third years of therapy. For     these reasons, the development of alternative therapy that would be at least as effective but     less toxic is of great importance. The drug ddI is an antiviral agent that inhibits     replication of HIV with less apparent toxicity than AZT. Studies indicate that ddI remains     active in the body for at least 12 hours; thus benefits of ddI might be achieved with a low     frequency of drug administration.   "
161097|NCT00000672|"     AMENDED: 8/29/90 Inclusion of asymptomatic patients with CD4 counts less than 200 cells/mm3.     Standardization of baseline evaluation schedule to allow 14 days prior to study dosing.     Reduction in frequency and intensity of follow-up evaluations. Standardization of study     endpoints. Inclusion of toxicity scoring and management for amylase and triglyceride     elevations. Clarification of concomitant medication use. Original design: To determine the     effectiveness of didanosine (ddI) in patients with AIDS or advanced AIDS related complex     (ARC) who have documented hematologic intolerance to zidovudine (AZT) therapy. To determine     if the efficacy of ddI increases with increasing doses.      AZT is effective in reducing mortality in patients with AIDS who receive the drug after the     first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC.     However, AZT therapy has been associated with significant toxicities. In addition, the     effectiveness of AZT appears to decrease during the second and third years of therapy. For     these reasons, the development of alternative therapy that would be at least as effective but     less toxic is of great importance. The drug ddI is an antiviral agent that inhibits     replication (reproduction) of HIV with less apparent toxicity than AZT. The major     dose-limiting toxicities found in the Phase I studies have been pains in the feet and legs of     2 patients initially receiving 12 mg/kg/day and 12 patients receiving daily doses of 25.8 to     51.2 mg/kg; symptoms began 8 to 27 weeks after initiating ddI treatment. These     neuropathy-like symptoms have generally not been associated with significant abnormalities in     nerve conduction studies and patients have reported marked improvement in symptoms within 1     to 2 weeks of discontinuing ddI. Some patients have resumed ddI treatment at a reduced dose     after resolution of their symptoms. Studies indicate that ddI remains active in the body for     at least 12 hours. This indicates that benefits of ddI might be achieved with a low frequency     of drug administration.   "
161098|NCT00000673|"     AMENDED: 04-12-91 Population of patients changed FROM those who are intolerant of systemic     therapy with NON-sight-threatening CMV retinitis TO those AIDS patients intolerant of     systemic therapy with CMV retinitis.      AMENDED: 8/8/90. Changes made in neutrophils count from < 500 to < 750 cells/mm3.     Nonrandomized eyes will not be used for the primary efficacy evaluation.      ORIGINAL DESIGN: To determine the effectiveness and safety of ganciclovir (DHPG) therapy in     AIDS patients suffering from active cytomegalovirus (CMV) infection of the retina of the eye     (retinitis) when the drug is administered directly into the fluid-filled vitreous cavity of     the eye by injection.      CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS     patients, and left untreated can lead to severe visual loss and blindness. While systemic     administration of DHPG has been shown to be an effective treatment for CMV retinitis, the     chronic administration required may be complicated by decreased blood cell counts     (granulocytopenia) which may require discontinuation of treatment. While withholding     treatment may allow recovery from the granulocytopenia, interruption of therapy may result in     reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be     of benefit to severely neutropenic patients with CMV retinitis.   "
161099|NCT00000674|"     To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine     and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients     with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most     frequent cause of focal central nervous system infection in patients with AIDS. If untreated,     the encephalitis is fatal. At present, it is standard practice to give a combination of     pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of     sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of     therapy difficult. There is some information that high doses of parenteral (such as by     injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus     sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients     with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however,     is costly, requires hospitalization, and is inconvenient for the patient. There is some     indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral     clindamycin may be effective. Leucovorin calcium is useful in preventing     pyrimethamine-associated bone marrow toxicity.   "
161100|NCT00000675|"     To study the safety and pharmacokinetics (blood levels) of recombinant human CD4     immunoglobulin (rCd4-IgG) in patients with AIDS or AIDS related complex (ARC) who have failed     or declined therapy with zidovudine (AZT). An additional goal of the study is to obtain a     preliminary indication of the antiviral effects of Cd4-IgG in patients with AIDS or ARC.      Other approaches in addition to existing treatment of HIV infection need to be evaluated. One     approach may be to block HIV infection by interrupting the assembly of the virus within the     cell or the budding of virus from the membrane of the infected cell. In addition, blocking     the attachment of HIV to its cellular receptor may offer another point of attack. HIV binds     to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus     (gp120) is capable of high affinity binding to CD4. Any agent that prevents the attachment of     gp120 to the CD4 receptor should be able to block virus transmission and spread. Recently,     scientists have succeeded in producing highly purified recombinant soluble human CD4.     Recombinant CD4 is capable of binding to HIV envelope protein (gp120) and inhibiting HIV     infectivity in test tube studies. Potential therapeutic benefit in patients with HIV     infection could be derived from either or both of these biologic effects. In order to extend     the length of time that rCD4 stays in the body, the compound has been modified by combining     it with a human immunoglobulin of the IgG1 class (IgG).   "
161101|NCT00000676|"     To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches     (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients     enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and     serious bacterial infection). Primarily, to compare the rates of invasive infections by C.     neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal     infections between two antifungal prophylactic treatments. Secondarily, to assess the effect     of prophylaxis on the incidence of severe fungal infections, defined as invasive infections     and esophageal candidiasis and less severe mucocutaneous infection.      Serious fungal infections are significant complicating and life-threatening occurrences in     patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such     patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly,     esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and     coccidioidomycosis also cause significant illness and death in AIDS patients. Once     established, fungal infections in AIDS patients generally require continuous suppressive     therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has     a number of characteristics that would make it a logical candidate to examine as a     prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to     be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and     coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis     appears favorable, and studies of oropharyngeal candidiasis show it to be effective.   "
161102|NCT00000677|"     To assess the safety and effectiveness of SCH 39304 as primary treatment of acute     cryptococcal meningitis in HIV-infected patients. Safety and effectiveness of maintenance     therapy following successful treatment of acute disease are also evaluated.      Cryptococcal meningitis is a significant cause of illness and death in HIV-infected patients.     Intravenous amphotericin B is effective for acute disease but relapse occurs in the majority     of patients. Maintenance therapy is recommended but must be balanced against the multiple     toxicities of the drugs used and the problems associated with the weekly administration of     intravenous therapy. Treatments that are equally or more effective and less toxic than     traditional methods are needed, especially oral therapy. SCH 39304 is an orally active     antifungal drug that in animal studies is active against a wide range of systemic fungal     infections including infections due to Cryptococcus. Features of SCH 39304 suggest that it     might be of value in the treatment of cryptococcal meningitis.   "
161103|NCT00000678|"     To compare the effectiveness of zalcitabine ( dideoxycytidine; ddC ) therapy to zidovudine (     AZT ) in the treatment of AIDS or advanced AIDS related complex ( ARC ) in patients who have     already received at least 1 year of AZT therapy and to define the safety profile.      ddC has been shown to have an antiviral effect, and AZT is known to significantly decrease     mortality and to reduce the frequency of opportunistic infections in patients with AIDS or     advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients     progress with more opportunistic infections and higher mortality rates. This may be due to     the emergence of AZT resistant virus isolated from some patients who have been on long-term     AZT therapy. These isolates were still sensitive to ddC. A study of long-term effectiveness     of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is     warranted because (1) ddC has antiviral activity, (2) there is no blood toxicity associated     with taking ddC, and (3) the effectiveness of ddC in test tube studies does not seem to be     diminished by decreased effectiveness of AZT.   "
161104|NCT00000679|"     To show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT)     in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC shows a     different safety profile than AZT.      In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and     because of the low incidence of mild, reversible neurotoxicity and absence of blood-related     toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in     patients with AIDS or advanced ARC is now warranted.   "
161105|NCT00000680|"     1) To determine whether it is possible to remove and culture (increase in number and     activate) in the laboratory, CD8(+) lymphocytes (white blood cells) from HIV-infected     patients receiving zidovudine (AZT); 2) To determine the toxicity of returning to the     patients intravenously the expanded and activated autologous cells (given to the patient from     whom they were taken), with and without giving the patients recombinant interleukin-2 (     aldesleukin; IL-2 ) at the same time; 3) To radiolabel (mark) the CD8(+) lymphocytes with     Indium 111, and then scan the patients to determine the distribution of the CD8(+)     lymphocytes in those who are and are not given IL-2 infusions; 4) To determine the toxicity     of IL-2 given at the same time with autologous CD8(+) lymphocytes; 5) To measure changes in     the immunology of the subjects following these treatments.      CD8(+) cells are suppressor/killer lymphocyte cells that act to limit replication of viruses.     It is hoped that the reinfusion of activated autologous CD8(+) cells into patients with AIDS     will help to control opportunistic infections such as cytomegalovirus and toxoplasmosis (two     of the leading causes of sickness and death in AIDS patients). This treatment may also stop     the HIV virus from replicating (reproducing itself) in the AIDS patient. Further activation     of these cells, once infused, may be necessary. It is hoped that IL-2 will stimulate the     patient's immune system against the AIDS virus along with the activated CD8(+) cells. Thus,     IL-2 will be given, and its effects studied.   "
161106|NCT00000681|"     To determine the safety as well as the most effective dose of sargramostim (GM-CSF;     granulocyte-macrophage colony stimulating factor) that will prevent the side effects caused     by the combined use of zidovudine (AZT) and various doses of cancer-fighting drugs     (doxorubicin, bleomycin, and vincristine) in AIDS patients with Kaposi's sarcoma (KS).      Patients included in this study have KS, which is a type of cancer that occurs in nearly 20     percent of patients with AIDS. AIDS patients with extensive KS require treatment with     effective cytotoxic (anti-cancer) agents to reduce the tumor size and with antiretroviral     agents such as AZT to prevent or ameliorate the development of opportunistic infections. Due     to the significant toxic effect of both cytotoxic and antiviral agents on the bone marrow     where new blood cells are generated, the combination of these agents is expected to result in     complications such as granulocytopenia (very low granulocyte counts). Hematopoietic growth     factors such as GM-CSF may reduce the severity and duration of marrow suppression. This may     improve survival. Clinical trials of GM-CSF in HIV infected individuals with or without     granulocytopenia have shown that the progenitor cells (early blood cells) are responsive to     GM-CSF.   "
161107|NCT00000682|"     To evaluate the efficacy of AZT versus ddC in terms of survival, antiviral effects,     neurological status, and health status in patients post Pneumocystis carinii pneumonia (PCP)     who received long-term AZT therapy in ACTG protocol 002 While treatment with AZT has been     found to be effective in prolonging survival and reducing the numbers of opportunistic     infections in patients with AIDS, during the second year of administration of AZT an     acceleration in mortality has been observed. The reasons for this are not known at this time.     The study of what may be an AZT-resistant strain of HIV may benefit patients who have been     and are still receiving AZT or another drug used in treating HIV ddC. It is hoped that the     comparison of the effectiveness of AZT and ddC will benefit in the treatment of these     patients.   "
161115|NCT00000690|"     To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when     taken by mouth. To evaluate its effect on blood coagulation.      DS has been reported to have anti-HIV activity. However, it is not known how much of the drug     is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.   "
161148|NCT00000117|"     To determine whether high-dose intravenous immunoglobulin (IVIg) is more effective than     placebo in restoring lost visual function (visual acuity) in optic neuritis (ON).      To determine the time course of recovery following IVIg administration. If the reports of     IVIg-associated clinical improvement occurring within 3 to 6 months following treatment can     be confirmed, this would provide indirect evidence that IVIg may promote central nervous     system (CNS) remyelination in optic neuritis and multiple sclerosis (MS).   "
161108|NCT00000683|"     Evaluation of the safety and immunogenicity (immunological reactivity) of HIVAC-1e vaccine.     An additional goal is to determine which dose level of vaccine might be most effective.     Specific questions to be addressed in this part of the study include: Are there adverse     reactions to gp160 vaccine when given to vaccinees previously immunized with a     vaccinia-recombinant? Does gp160 vaccination of prior HIVAC-1e vaccine result in stimulation     of neutralizing antibody and other humoral immune responses? Does vaccination with gp160     enhance the development of cell-mediated immune responses in HIVAC-1e vaccinees? Is the     magnitude of immune response to gp160 booster immunization greater following priming with     GP160 recombinant vaccinia (HIVAC-1e) vaccination than priming with three doses of purified     recombinant gp160? AMENDED: An 80 mcg dose of gp160 has been chosen for the booster because     this dose has been shown to be safe and immunogenic in previous trials and allows comparison     of the late boost in this protocol with the late boost in the protocol in which patients were     primed with three doses of gp160. Original design: HIVAC-1e vaccine is a preparation of the     envelope protein of HIV (the virus that causes AIDS). The protein is produced by genetic     modification in vaccinia virus. The purpose of a vaccine is to produce an artificially     increased immunity to a particular disease, in this case, AIDS. Since there is no known cure     for AIDS, the control of this disease necessitates the development of effective prevention     such as vaccines.   "
161109|NCT00000684|"     To determine the safety and effectiveness of dextran sulfate when it is administered     intravenously at the maximum tolerated dose (MTD) as a treatment for HIV infection in AIDS     patients. The effect of dextran sulfate on platelet survival will also be assessed in 3     patients to help determine the mechanism of thrombocytopenia (low platelets) noted in all     patients receiving intravenous dextran sulfate in this study.      Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted     in humans to determine its effect on HIV when dextran sulfate is given orally have not been     conclusive. It is hoped that this study will show that dextran sulfate administered     intravenously   "
161110|NCT00000685|"     To determine how zidovudine (AZT) for the treatment of HIV infection is metabolized and     excreted or eliminated in patients with infected or diseased kidneys. To determine the     influence of hemodialysis and establish dose guidelines.      AZT is the only antiviral agent with demonstrated effectiveness in patients with severe HIV     infection. Persons with HIV infection may have additional health problems, one of which is a     diseased kidney due to infection of the kidney, or side effects of therapy. The benefits and     risks of AZT in patients with diseased kidneys are unknown. It is hoped that this study will     allow further understanding of the metabolism and excretion of AZT in patients with kidney     disease. AZT pharmacokinetics will be studied in patients with mild, moderate, and severe     renal disorders   "
161192|NCT00000162|"     To determine whether scatter argon laser photocoagulation can prevent the development of     neovascularization.      To determine whether peripheral scatter argon laser photocoagulation can prevent vitreous     hemorrhage.      To determine whether macular argon laser photocoagulation can improve visual acuity in eyes     with macular edema reducing vision to 20/40 or worse.   "
193707|NCT00380484|"     The purpose of this study is to assess if treatment with budesonide 200 microgram per day     affects short- or long term growth in children with asthma   "
161111|NCT00000686|"     To determine the safety and maximum tolerated dose (MTD) of     2',3'-dideoxy-2',3'-didehydrothymidine (d4T) administered to patients with AIDS or AIDS     related complex (ARC) who are intolerant of zidovudine (AZT). The study also begins an     assessment of the effectiveness of d4T therapy on HIV replication, on plasma levels of p24     antigen, and clinical or immunologic parameters associated with AIDS.      Of the methods that are being evaluated to treat HIV-infected individuals, AZT has produced     the best results to date. Toxic effects in approximately 50 percent of patients receiving AZT     may limit its usefulness for prolonged treatment. Long-term treatment may be necessary to     prevent progression of early stage HIV infection to AIDS and to prevent secondary     transmission. Other drugs that may be equally or more effective than AZT and useful in the     long- term treatment of HIV infection must be developed and evaluated. Test-tube and animal     studies of d4T show that the drug can inhibit replication (reproduction) of HIV at     concentrations similar to concentrations of AZT that have anti-HIV activity. These studies     also indicate that the drug may stay in the bloodstream longer than AZT. Thus, it may be     possible for the drug to be as effective as AZT when taken less frequently than AZT. It also     may have a less disturbing effect on other body functions (such as thymidine metabolism).   "
161112|NCT00000687|"     To determine the safety and effectiveness of combining zidovudine (AZT) and interferon     alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is     hoped with the present study to define the rate at which the treatment affects the tumors and     also to assess any toxic effects of the combination treatment over a period of time.      In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with     AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In     addition, it appeared that there was a substantial reduction in KS lesions with this therapy.     Potential benefits of this combined therapy include resolution of KS lesions, prolonged     survival, a decrease in the frequency and severity of opportunistic infections, improvement     in CD4 cells, and a decrease in serum p24 antigens.   "
161113|NCT00000688|"     To provide information about the usefulness and safety of giving injections of ganciclovir     (DHPG) for treating peripheral cytomegalovirus (CMV) retinitis.      CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2     out of every 10 patients with AIDS. Results from an earlier study suggest that about 80     percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.   "
161128|NCT00000703|"     To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine     (AZT) treatment for patients with peripheral lymphoma.      Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results     have not been satisfactory. This study will show whether the combination of chemotherapy,     radiation, and AZT is more effective and less toxic than previously used treatments.   "
161149|NCT00000118|"     To determine the therapeutic efficacy of a sustained-release intraocular drug delivery system     for ganciclovir therapy of cytomegalovirus (CMV) retinitis in patients with acquired     immunodeficiency syndrome (AIDS).   "
161516|NCT00000503|"     To assess the effect of non-surgical reperfusion on infarct size in patients with acute     myocardial infarction.   "
161116|NCT00000691|"     To examine the usefulness and safety of the antiviral drug foscarnet in treating AIDS     patients with cytomegalovirus (CMV) infection that is causing sight-threatening inflammation     of the retina in one or both eyes (CMV retinitis). Because of the seriousness of     sight-threatening CMV retinitis in AIDS patients and a lack of other available treatments for     those patients who cannot be treated with ganciclovir (DHPG) (because of its toxic effect on     the body's blood-forming cells, because it did not control the disease, or because patient's     blood cell or platelet counts are too low to begin with), it is worthwhile to try an     immediate trial with foscarnet. AMENDED: ACTG 093 was originally designed as a randomized     dose-ranging study of foscarnet maintenance therapy. Patients enrolled between March 17,     1989, and January 1, 1990, received either 60 mg/kg/day or 90/mg/kg day as maintenance     therapy following the 2 week induction period. Based on the preliminary results of ACTG     015/915, which studied maintenance doses of foscarnet of 60 mg/kg/day, 90 mg/kg/day and 120     mg/kg/day, the 60-mg/kg/day and 90/mg/kg/day arms of this study have been closed. All     patients entering the study beginning January 2, 1990 will receive foscarnet maintenance     therapy on a 120/mg/kg/day algorithm following induction.   "
161117|NCT00000692|"     To determine the following about the use of SC-48334 in patients with AIDS and advanced AIDS     related complex (ARC):      1. The largest maximum tolerated dose (MTD); 2. Effectiveness against HIV; 3.     Pharmacokinetics - how fast SC-48334 reaches the bloodstream, what concentration is reached,     and how long it remains in the patient's blood.      SC-48334 is a chemical that prevents the biochemical actions of certain enzymes in the body,     and recent studies have shown that it may also prevent the activity of HIV. The study will     attempt to show whether SC-48334 can safely and effectively break the cycle of HIV infection     in AIDS and advanced ARC by progressively eliminating HIV.   "
161123|NCT00000698|"     To determine the safety and effectiveness of intravenous ganciclovir (also known as DHPG) in     the treatment of sight-threatening cytomegalovirus (CMV) retinitis in patients with AIDS. CMV     retinitis is a severe vision-threatening viral infection of the retina of the eye. It occurs     in patients whose immune function has been impaired and is the most common cause of blindness     in patients with AIDS. Ganciclovir (GCV) improved the signs and symptoms of CMV retinitis in     approximately 80 percent of the patients treated for 2 weeks, but almost all of the patients     treated with GCV had a relapse after treatment was stopped. Thus, it is important to     determine if GCV can be safely given over a long period of time (maintenance therapy) and if     it is effective in preventing a relapse of CMV retinitis.   "
161458|NCT00000444|"     This study will attempt to determine the best time to begin a smoking cessation program in     individuals who undergo intensive treatment for alcohol dependence. The goal of this trial is     to determine whether a smoking cessation program is more effective if it occurs at the same     time as or after treatment for alcohol dependence. The study also will attempt to determine     the effect of smoking cessation programs on the outcome of treatment for alcohol dependence.   "
161118|NCT00000693|"     To study the use of acyclovir (ACV) and zidovudine (AZT) in the treatment of cytomegalovirus     (CMV) retinitis in patients with AIDS who would otherwise be treated with ganciclovir (DHPG)     alone.      CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG     is at present the only drug available for widespread compassionate use in the United States.     Although most patients respond to treatment with DHPG, the medication does not cure the     infection. Most patients will have a relapse and will require retreatment with DHPG. Because     of the large relapse rate, most people treated for CMV retinitis are placed on continuous     treatment with DHPG. There are two major problems associated with ongoing use of DHPG: 1) The     development of a low white blood cell (WBC) count (leukopenia) which is a known side effect     of the drug; and 2) the increased risk for leukopenia when DHPG is given together with AZT,     the only antiviral drug currently available for the treatment of HIV infection. Therefore,     patients cannot take both AZT and DHPG at the same time because the bone marrow toxicity is     made much more severe when the drugs are given together. This has resulted in the difficult     decision as to whether to forgo potential life-extending therapy with AZT in order to     preserve sight. An effective treatment for CMV retinitis is needed that will allow the     patient to also take AZT. ACV is presently the drug of choice for severe herpes virus     infections. It has been shown to be effective in suppressing severe CMV disease in patients     who have received bone marrow transplants.   "
161119|NCT00000694|"     To define the best doses of sargramostim ( granulocyte-macrophage colony-stimulating factor;     GM-CSF ), interferon alfa-2b ( IFN-A2b ), and zidovudine ( AZT ) to give together in patients     with AIDS-associated Kaposi's sarcoma ( KS ), to learn about the side effects of these drugs     when they are given together for 8 weeks, and to find out whether the combination of GM-CSF,     IFN-A2b, and AZT has any effect on KS, HIV, or the immune system.      Studies show that IFN-A2b can cause KS tumors to shrink or disappear in about 30 percent of     patients. IFN-A2b can greatly reduce the growth of the HIV virus in test tube experiments and     perhaps in patients. AZT has also been shown to reduce the growth of HIV and show     improvements in the immune system with fewer infections. Test tube experiments show that when     IFN-A2b and AZT are used together, they reduce the growth of the HIV virus much more     effectively than when either drug is used alone. In recent studies of the combination of     interferon alpha and AZT in patients with KS, more than 40 percent of the patients showed     shrinkage of their tumors, and some showed evidence for suppression of HIV growth in the     body. However, the combination of IFN-A2b with AZT often caused a marked lowering of the     white blood cell (WBC) count, especially a type of WBC called the granulocyte (or neutrophil)     which is important in the body's defense against infection. Recombinant human GM-CSF is a     human protein which is produced in bacteria. It has been shown to cause an increase in the     WBC count.   "
161129|NCT00000704|"     To evaluate the long-term safety and effectiveness of the drug 2',3'-dideoxycytidine (     zalcitabine; ddC ) in treating patients with AIDS or advanced AIDS related complex ( ARC ).      Recent studies show that a certain group of drugs (dideoxynucleosides) are effective in     treating patients with HIV infection. ddC is a dideoxynucleoside and test tube studies show     that it may be valuable in treating AIDS patients. ddC has been shown to be well tolerated in     certain patients with AIDS.   "
161150|NCT00000119|"     To investigate the safety and efficacy of a heparin surface-modified intraocular lens in     patients with uveitis undergoing cataract surgery.      To evaluate the safety and efficacy of intraocular lens implantation in patients with severe     uveitis.   "
161120|NCT00000695|"     To determine the highest tolerated dose of the safety and tolerance of interferon beta     (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS     related Kaposi's sarcoma. In addition, the studies will determine preliminary data on     response, immune function, and subcutaneous absorption.      IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the     test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV     reverse transcriptase; Phase I and II study benefits of AZT treatment include increased     objective clinical improvement, decreased mortality rate, and decreased incidence of     opportunistic infections. Long-term AZT use, however, presents possible limitations secondary     to intolerance. This study, therefore, will investigate the potential antiviral activities of     a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in     patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy     consisting of low doses of each drug will reduce the potential of toxicity, treatment     failures, and disease recurrences resulting from drug-resistant virus mutants.   "
161121|NCT00000696|"     To evaluate the anti-HIV effect of single agent versus combination therapy with zidovudine     (AZT) and interferon alfa-2a (IFN-A2a), as measured by p24 protein expression, viral growth     and infectivity in patients with symptomatic HIV disease. To assess the safety of low dose     schedules of AZT and IFN-A2a, alone and in combination, as measured by neutrophil counts and     hepatic transaminase levels. To evaluate the comparative effects of single agent versus     combination therapy with AZT and IFN-A2a on CD4 cell counts and skin test reactivity.      AZT is known to be an effective treatment for HIV infection. However, patients may develop     reactions to AZT when it is administered for long periods of time. Combining AZT with another     drug at lower doses might reduce toxicity in patients and prevent the development of drug     resistant strains. IFN-A2a can reduce the growth of HIV in test tube experiments and recent     studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV     more effectively than when either drug is used alone. This study will examine the     effectiveness and safety of these drugs when they are given together and compare these     results with the effectiveness and safety of the drugs when they are used alone.   "
161122|NCT00000697|"     To study the safety and effectiveness of foscarnet in the treatment of AIDS patients who have     active infection with cytomegalovirus (CMV) that is causing inflammation of the retina     (retinitis). In addition, these patients cannot be treated with ganciclovir (DHPG) because of     its toxic effect on the body's blood-forming cells or because white blood cell or platelet     counts were too low.      CMV is a common virus, which can cause blindness and death in AIDS patients. Previous studies     demonstrate that foscarnet has been effective in both AIDS and non-AIDS patients with CMV     infection. Although treatment with ganciclovir (DHPG) is also effective, a significant     toxicity leading to dose-limiting neutropenia (low white blood cell count) in one third of     treated patients has been associated with the drug. Based on the serious nature of CMV     retinitis and the lack of alternative drug therapies for DHPG-sensitive patients, the present     study will evaluate the safety and efficacy of intravenous (IV) foscarnet in AIDS patients     with CMV retinitis.   "
161141|NCT00000716|"     To evaluate the safety and tolerance of oral zidovudine (AZT) when given over a period of 24     weeks to children between 3 months and 12 years of age. The effectiveness of AZT in treating     HIV infection in infants and children will also be evaluated.      HIV infection in children is most often associated with symptomatic disease and poor     prognosis. Treatment with antiviral therapy may be effective in altering the course of the     disease and decreasing mortality in these children. AZT has been shown to be effective in     certain adult patients with symptomatic HIV infection. It is therefore likely that infected     children may also benefit from this treatment.   "
161124|NCT00000699|"     To determine the safety and effectiveness of treatment with ribavirin (RBV) plus isoprinosine     (INPX) in preventing the development of AIDS in patients infected with the AIDS virus (HIV).     Also to determine the maximal dose of RBV that can be tolerated by HIV-infected patients when     RBV is given with INPX. The patients may or may not have generalized lymphadenopathy syndrome     (LAS). RBV has prevented the development of AIDS in some HIV-infected patients with LAS and     INPX has stimulated the immune system of patients infected with HIV. The immune system fights     infections in the human body, and the HIV attacks T cells that are an important part of the     immune system. Reports from individual cases treated with both RBV and INPX suggest that     clinical improvements occurred in HIV-infected patients, but there is no reliable information     on the safety and effectiveness of this drug combination in such patients.   "
161125|NCT00000700|"     To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study     of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower     dose results in less harmful side effects while still being effective. Previous studies have     shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies     at varying doses. There is a need to see if lower doses result in effective therapy with less     harmful side effects.   "
161126|NCT00000701|"     The study is designed to test the drug zidovudine (AZT) in children, including study of drug     levels in various parts of the body fluids, safety of the drug, and its effect on different     parts of the body.      The effects of any drug, the way a drug enters the bloodstream, the way it is used by the     body, and the way the body eliminates the drug may be very different in children compared     with adults. The largest group of children who have AIDS are those who are less than 2 years     of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT     show that it might be useful in the treatment of AIDS. Thus it is important to study the     effects of the drug in children.   "
161127|NCT00000702|"     To test whether zidovudine (AZT) is useful as a treatment for the neurologic syndrome called     AIDS dementia complex. To determine how long AZT takes to reach cerebral spinal fluid (CSF),     how long, and at what concentration it is found there.      HIV infection can result in impairment in the function of the brain and spinal cord, leading     to disturbances in the ability to think clearly and in strength and coordination. This     disorder, which has been called the AIDS dementia complex, may be due to a direct effect of     HIV on the nervous system. It is known that AZT does get into the brain to some extent, where     it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the symptoms of     the AIDS dementia complex.   "
161146|NCT00000115|"     To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular     edema.   "
161130|NCT00000705|"     The purpose of this study is to see if giving azidothymidine (AZT) to HIV-positive patients     with hemophilia is safe and if it is effective in lowering HIV levels and boosting the immune     system.      HIV infects and inactivates certain blood cells that are part of the body's immune system.     The damage to the body's immune system can result in unusual infections and/or unusual forms     of cancer. A large percentage of hemophiliacs are HIV-positive and there is a clear risk for     the development of AIDS in these patients. AZT may be effective in lowering HIV levels and     boosting the immune system but its side effects are not understood in these patients.   "
161131|NCT00000706|"     Part I studies the effect of quinine on how zidovudine (AZT) is used by the body and     eliminated through the kidneys in HIV infected patients. Part II studies the effect of     probenecid and quinine on the same aspects.      Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep     adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT     leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT     needed for treatment.   "
161132|NCT00000707|"     To confirm the ability of pulmonary (lung) function testing (PFT) to detect Pneumocystis     carinii pneumonia (PCP) before the development of clinical symptoms and to determine if     pentamidine (PEN), a drug used in treating PCP, can be given effectively as an aerosol     (inhaled mist). Other goals include the measurement of the actual amount of PEN that reaches     the lung, and to determine if close clinical observation is safer and as effective as drug     therapy for the prevention of subsequent episodes of PCP.      Many AIDS patients develop PCP, but the effectiveness of early diagnosis and treatment of PCP     is not known. The effectiveness of PEN may be improved if treatment is begun when the     parasite burden (the number of organisms in the lung) is still small, and before respiratory     symptoms appear. If PFT of HIV-infected patients is able to identify patients in the early     stages of infection, outpatient treatment of these patients offers a possible alternative to     the expense and toxicity of continuous preventive therapy of all high-risk patients.   "
161133|NCT00000708|"     To compare the safety and effectiveness of fluconazole (FCZ) and amphotericin B (AMB), alone     or in combination with flucytosine (FLC), as treatment for acute cryptococcal meningitis in     patients who have not been treated previously or who have relapsed after a previous     successful treatment.      Cryptococcal meningitis is an important cause of disease and death among patients with AIDS.     Usually AMB is given either alone or with FLC to patients with this infection, but these     treatments are not always effective and both have toxic effects. Animal studies and     preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest     that it may be less toxic than either AMB or FLC.   "
161471|NCT00000458|"     This study will assess whether individuals treated with sertraline (Zoloft) and cognitive     behavior therapy will experience improvement with their depression and consume less alcohol     than individuals treated with a placebo and cognitive behavior therapy. This is a 12-week,     random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3     months after treatment.   "
161134|NCT00000709|"     To provide accurate and complete neurologic assessment of the course of the AIDS dementia     complex in patients treated with zidovudine (AZT). The study will determine how frequently     patients improve, how long improvement is sustained, and the magnitude and functional     significance of improvement.      Individuals with AIDS frequently suffer central nervous system (CNS) problems that are     characterized by cognitive, motor, and behavioral deficits, in a disorder known as AIDS     dementia complex. Clinical experience suggests that its course is often progressive, going     from initial symptoms to moderate or severe dementia within several months. Accumulating     evidence now suggests that direct brain infection by the HIV virus is the likely cause of the     AIDS dementia complex. Case reports suggest that therapy with AZT, which has been shown to be     a strong inhibitor of HIV replication in vitro, may alleviate the AIDS dementia complex. This     study will help define the natural history of the AIDS dementia complex in treated patients.   "
161135|NCT00000710|"     To determine the safety, pharmacokinetics (blood levels), and effectiveness of didanosine     (ddI) when administered both intravenously and orally. After the maximum tolerated dose (MTD)     is determined, an appropriate dosage regimen will then be established for Phase II and Phase     III trials.      Zidovudine (AZT) has produced the best clinical results in the drug therapy of AIDS to date,     but it produces toxicity in approximately 50 percent of patients. Early data show that ddI     possesses high antiviral activity and less toxicity than AZT. The most effective route and     dose of ddI has yet to be determined.   "
161136|NCT00000711|"     To administer colony-stimulating factor (GM-CSF) for 4 weeks to AIDS and advanced AIDS     related complex (ARC) patients who have been receiving zidovudine (AZT) therapy, in order to     obtain data on short-term effectiveness, safety, toxicity, pharmacokinetics, and tolerance of     combined treatment with the two drugs.      Persons infected with HIV virus may undergo a long latency or persistent virus blood levels     which may be present before any symptomatic illness. These individuals could, therefore,     benefit from therapy with an effective antiretroviral agent. AZT, which is a powerful     inhibitor of human retrovirus, has been approved for management of patients with symptomatic     HIV infection. GM-CSF not only stimulates the bone marrow, it enhances the function of mature     blood cells and has been found to enhance the ability of AZT to suppress HIV replication in     vitro (test tube). Combination therapy with GM-CSF and AZT may lower complications as well as     the morbidity and mortality associated with HIV infection.   "
161137|NCT00000712|"     Original design: The study's purpose is to compare the effects of zidovudine (AZT) alone to     the combination of AZT and acyclovir (ACV) to determine if AZT/ACV is associated with a lower     death rate and fewer AIDS related opportunistic infections compared to AZT alone, and to     investigate the effect of these treatment plans on cytomegalovirus (CMV) and Epstein-Barr     virus (EBV) infections. The study evaluates two doses of AZT used alone versus two doses of     AZT combined with ACV. Per 12/11/92 amendment: Another antiretroviral agent may be     substituted for AZT.      AZT has been shown to increase the life span of patients with AIDS or advanced AIDS related     complex and patients being treated for Pneumocystis carinii pneumonia. Drugs that increase     the effectiveness of AZT against HIV may also decrease the need for high doses of AZT. This     might reduce some of the negative effects of AZT while not reducing the positive effects.   "
161147|NCT00000116|"     The purpose of this trial is to determine whether a nutritional supplement in addition to     vitamin A will slow the course of retinitis pigmentosa.   "
161138|NCT00000713|"     To determine the safety of ampligen at several doses in HIV-infected patients who have not     yet developed AIDS or advanced AIDS related complex (ARC). Biologic, antiviral, and     immunologic effects will be studied.      Evidence indicates that a long period with no symptoms follows infection with HIV.     Individuals who are infected with the virus could benefit from therapy with a drug that acts     to kill the virus or to stimulate the immune system of the individual or both. The immune     system is the means the human body has for fighting infections. Ampligen is a suitable drug     for clinical trials against HIV because it has been shown to stimulate the immune system and     to inhibit HIV in vitro (test tube) at drug levels that can be achieved without noticeable     clinical side effects.   "
161139|NCT00000714|"     To determine the safety and effectiveness of an investigational drug therapy (trimetrexate     plus leucovorin calcium (TMTX / LCV)) in the treatment of Pneumocystis carinii pneumonia     (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection, and     who have suffered severe or life-threatening ill effects from both conventional therapies for     PCP. AMENDED: 08/01/90 As of August 31, 1989, 437 patients were enrolled into uncontrolled     studies of trimetrexate for PCP:214 in TX 301/ACTG 0=039 (trimetrexate for patients     intolerant of approved therapies) and 223 in NS 401 (trimetrexate for patients refractory to     approved therapies). The analysis of overall response rate, stringently defined as having     received at least 14 days of trimetrexate and being alive at follow-up 1 month after the     completion of therapy, reveals 84/159 intolerant patients and 48/160 refractory patients had     responded, for rates of 53 percent and 30 percent, respectively. These response rates include     all individuals who received at least one dose of trimetrexate. Of the 111 patients who were     ventilator-dependent at study entry, 18 completed a course of therapy and were alive a month     later, for a response rate of 16 percent. All other ventilated patients died. The most common     severe (grades 3 and 4) toxicities were: transaminase elevation (> 5 x normal) in 94     patients, anemia (< 7.9 g/dl) in 109, neutropenia (< 750 cells/mm3) in 58, fever (> 40 C) in     37, and thrombocytopenia (< 50000 platelets/mm3) in 27. Toxicity required discontinuation of     therapy in approximately 5 percent of all patients.      Original design: The drugs usually used to treat PCP in AIDS patients, trimethoprim /     sulfamethoxazole and pentamidine, have had to be discontinued in many patients because of     severe side effects. Currently there are no proven alternatives to these drugs. TMTX was     chosen for this trial because it was found to be very active against the PCP organism in     laboratory tests. Also TMTX, in combination with LCV, had a high response rate and did not     cause severe toxicity in a preliminary trial.   "
161140|NCT00000715|"     To compare the safety and effectiveness of drug therapy with aerosolized pentamidine (PEN)     with that of conventional therapy, sulfamethoxazole plus trimethoprim (SMX/TMP) in the     treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV     positive, or are at high risk for HIV infection.      New treatments are needed for PCP, a common lung infection in patients with AIDS, because     many patients treated with the two standard treatments, PEN given by injections and SMX/TMP,     have had adverse effects that required a change in treatment. There is also a high relapse     rate after the standard treatments. Preliminary experiments in humans suggest that     aerosolized PEN is as effective as the standard treatments for PCP, and causes few adverse     effects.   "
161171|NCT00000140|"     To compare, through a randomized, multicenter surgical trial, the postoperative tamponade     effectiveness of intraocular silicone oil with that of an intraocular long-acting gas     (initially sulfur hexafluoride [SF 6 ], later perfluoropropane [C 3 F 8 ]) for the management     of retinal detachment complicated by proliferative vitreoretinopathy (PVR), using vitrectomy     and associated techniques.      To evaluate the ocular complications that result from the use of silicone oil and gas.   "
161142|NCT00000717|"     To determine the safety and effectiveness of clindamycin and primaquine in the treatment of     mild Pneumocystis carinii pneumonia (PCP) in AIDS patients.      As many as 80 percent of AIDS patients experience at least one episode of PCP and about     one-third of these patients have a recurrence of the disease. Drugs currently used for     treatment of acute PCP are toxic to the majority of AIDS patients. The combination of     clindamycin and primaquine reduces the numbers of PCP organisms in laboratory tests and in     animal studies. Both drugs can be given orally, concentrate in lung tissue, and have been     used safely in humans for treatment of other diseases. It is possible that the combination     may prove to be as good or better than standard therapy for PCP and side effects may be less.   "
161143|NCT00000718|"     To determine if alternating zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) (first     one and then the other) or intermittent therapy (1 week of drug then 1 week off) will lessen     the toxic effects of either drug alone, while still inhibiting HIV (the AIDS virus) in     patients with AIDS or AIDS related complex.      AZT extends the survival of some patients with AIDS, and both AZT and ddC are known to     inhibit the growth of HIV. When AZT or ddC is given continuously over a prolonged period of     time, toxic effects occur that are not found when the drugs are given for 4 - 6 weeks. It is     hoped that by alternating the drugs or by giving one drug intermittently, the toxic effects     can be decreased without lowering the therapeutic effectiveness of the drugs.   "
161144|NCT00000719|"     To determine the long-term safety and tolerance of four alternating and two intermittent     regimens of zidovudine ( AZT ) and 2',3'-dideoxycytidine ( zalcitabine; ddC ) in the     treatment of patients with advanced HIV disease who have had to discontinue AZT because of     true hematologic intolerance to standard reduced doses of AZT.      AIDS is a serious infectious disease caused by a new family of retrovirus which is spread     primarily through sexual contact and administration of blood or blood products. Individuals     who are infected with HIV could therefore benefit from therapy with an effective anti-AIDS     virus agent. AZT and ddC have both been tested as antiviral agents and their potentially     beneficial effects may be limited by time- and dose-dependent toxicity. A combination regimen     using shorter courses of AZT and ddC might therefore be able to sustain treatment without     producing toxicity. In addition, since the two drugs exhibit their major toxicity on     different organ systems, cumulative or additive toxicity would not be expected.   "
161145|NCT00000720|"     To evaluate the clinical, immunologic, and virologic effects of oral zidovudine (AZT) plus     intravenous immunoglobulin (IVIG) versus AZT plus placebo (albumin). It is estimated that by     1991, there may be 10,000 to 20,000 HIV-infected children in the United States. HIV infection     in children is most often associated with symptomatic disease and poor prognosis. Treatment     with antiviral therapy may be effective in changing the course of disease and decreasing     mortality in this vulnerable population. AZT treatment has been shown to decrease mortality     and the frequency of opportunistic infections in certain adult AIDS patients; therefore, it     is likely that children may also benefit from this antiviral therapy. In addition, bacterial     infections are frequently found in HIV-infected children. Because pooled human serum     immunoglobulin, another name for antibodies, is effective in reducing bacterial infection in     patients with defects of immunity, it may reduce the rate of bacterial infection in     HIV-infected children as well. In this study, AZT will be administered together with IVIG to     determine safety, tolerance, and efficacy of the combined treatment.   "
161152|NCT00000121|"     To determine whether the preoperative use of prisms in eyeglasses can improve the outcome of     surgery for acquired esotropia, a type of strabismus.      To determine whether patients who respond to prism adaptation by developing a new stable     angle of -deviation have a better surgical result than do patients who do not respond to     prism adaptation.      To determine whether patients who respond to prism adaptation are more accurately corrected     by operating for the prism-adapted angle or the original angle of deviation.      To determine the usefulness of certain input variables (e.g., age at the time of surgery,     size of the deviation, visual acuity, binocular function, refractive error) in predicting     which patients are more likely to benefit from prism adaptation.   "
161153|NCT00000122|"     To determine whether postoperative subconjunctival injections of 5-fluorouracil (5-FU)     increase the success rate of filtering surgery in patients at high risk for failure after     standard glaucoma filtering surgery.   "
161172|NCT00000142|"     To test and evaluate the efficacy and safety of intravenous cidofovir (Vistide, previously     known as HPMPC) for the treatment of retinitis.   "
161173|NCT00000143|"     To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir     intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss.      To compare a treatment regimen that incorporates highly active local therapy (ganciclovir     device) with a treatment regimen that does not.   "
161174|NCT00000144|"     To compare the safety and long-term efficacy of argon laser treatment of the trabecular     meshwork with standard medical treatment for primary open-angle glaucoma.   "
161154|NCT00000123|"     To evaluate the relative efficacy of orthokeratology, primarily by assessment of changes in     central corneal thickness, astigmatism, visual acuity, endothelial cell density, and corneal     curvature.      To evaluate the relative safety of orthokeratology, primarily by assessment of changes in     central corneal thickness, astigmatism, visual acuity, endothelial cell density, induced     corneal edema, and epithelial staining.      To assess the duration of any orthokeratology treatment effect.      To study the mechanisms by which refractive error and visual acuity changes occur, in     particular the contribution that comes from changes in corneal curvature and shape.      To determine whether there were any predisposing ocular factors that could be used to predict     which subjects will experience changes or complications.   "
161155|NCT00000124|"     To evaluate therapeutic interventions for patients who have choroidal melanoma, the most     common primary eye cancer affecting adults, and to assess the potential life-preserving as     well as sight-preserving role of radiation therapy.      To determine which of two standard treatments, removal of the eye or brachytherapy, is more     likely to prolong survival of eligible patients with medium-sized choroidal melanoma.      To determine whether preoperative radiation prolongs life for patients whose eyes with large     choroidal melanoma are enucleated.   "
161156|NCT00000125|"     To determine whether medical reduction of intraocular pressure prevents or delays the onset     of glaucomatous visual field loss and/or optic disc damage in ocular hypertensive     participants judged to be at moderate risk for developing open-angle glaucoma.      To produce natural history data to assist in identifying patients at most risk for developing     open-angle glaucoma and those most likely to benefit from early medical treatment.      To quantify risk factors for developing open-angle glaucoma among ocular hypertensive     individuals.   "
161157|NCT00000126|"     To follow all patients enrolled in the original Ischemic Optic Neuropathy Decompression Trial     (IONDT) to determine (1) the incidence of non-arteritic ischemic optic neuropathy (NAION) in     the second eye, (2) changes in visual acuity over time in both the study and second eye, and     (3) other aspects of the natural history of NAION.   "
161158|NCT00000127|"     To assess the safety and efficacy of optic nerve sheath decompression surgery for     non-arteritic ischemic optic neuropathy (NAION).   "
161159|NCT00000128|"     To test the hypothesis that correction with bifocal spectacle lenses rather than     single-vision lenses will slow the progression of myopia in children with near-point     esophoria. The primary outcome variable is cycloplegic refraction as measured with an     automated refractor. Axial length is measured with ultrasound in order to test the corollary     hypothesis that use of bifocals will slow ocular growth in these myopic children. We will     also examine the amount of close work performed by subjects and the degree of parental myopia     as factors that may influence myopia progression.   "
161160|NCT00000129|"     To determine whether radial keratotomy is effective in reducing myopia.      To detect complications of the surgery.      To discover patient characteristics and surgical factors affecting the results.      To determine the long-term safety and efficacy of the procedure.   "
161161|NCT00000130|"     To determine the role of initial pars plana vitrectomy in the management of postoperative     bacterial endophthalmitis.      To determine the role of intravenous antibiotics in the management of bacterial     endophthalmitis.      To determine which factors, other than treatment, predict outcome in postoperative bacterial     endophthalmitis.   "
161162|NCT00000131|"     To determine whether photocoagulation therapy can help prevent iris neovascularization in     eyes with central vein occlusion (CVO) and evidence of ischemic retina.      To assess whether grid-pattern photocoagulation therapy will reduce loss of central visual     acuity due to macular edema secondary to CVO.      To develop new data describing the course and prognosis for eyes with CVO.   "
161163|NCT00000132|"     The primary purpose is to compare the effect of immediate therapy to lower the intraocular     pressure (IOP) versus late or no treatment on the progression of newly detected open-angle     glaucoma, as measured by increasing visual field loss and/or optic disc changes.      The secondary purposes are to determine the extent of IOP reduction attained by treatment, to     explore factors that may influence glaucoma progression, and to describe the natural history     of newly detected glaucoma.   "
161164|NCT00000133|"     To determine the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in     certain low birth-weight infants with retinopathy of prematurity (ROP) for reducing blindness     from ROP.      To determine the long-term outcome for eyes that had severe (threshold) ROP, both with and     without cryotherapy.   "
161517|NCT00000504|"     To compare the effectiveness of various drugs and drug combinations in suppressing complex     ventricular arrhythmias, and to evaluate their safety.   "
161519|NCT00000506|"     To determine the long-term efficacy of the combination therapy of phentermine and     fenfluramine in conjunction with diet, exercise, and behavior modification in the treatment     of simple, moderate obesity.   "
161165|NCT00000134|"     To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV     retinitis who have been previously treated but whose retinitis either is nonresponsive or has     relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and     (3) combination foscarnet and ganciclovir.      To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis:     (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.   "
161166|NCT00000135|"     To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as     adjunct therapy for controlling CMV retinitis.   "
161167|NCT00000136|"     To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial     treatment of patients with cytomegalovirus (CMV) retinitis.   "
161168|NCT00000137|"     To determine whether histocompatibility matching of corneal transplant donors and recipients     can reduce the incidence of graft rejection in high-risk patients.   "
161169|NCT00000138|"     To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal     keratitis in conjunction with topical trifluridine.      To evaluate the efficacy of oral acyclovir in treating herpes simplex stromal keratitis in     patients receiving concomitant topical corticosteroids and trifluridine.      To evaluate the efficacy of oral acyclovir in treating herpes simplex iridocyclitis in     conjunction with treatment with topical corticosteroids and trifluridine.   "
161170|NCT00000139|"     To determine whether early treatment (with oral acyclovir) of herpes simplex virus (HSV)     ulcerations of the corneal epithelium prevents progression to the blinding complications of     stromal keratitis and iridocyclitis.      To determine the efficacy of low-dose oral acyclovir in preventing recurrent HSV eye     infection in patients with previous episodes of herpetic eye disease.      To determine the role of external factors (such as ultraviolet light or corneal trauma) and     behavioral factors (such as life stress) on the induction of ocular recurrences of HSV eye     infections and disease.   "
161180|NCT00000150|"     To determine whether surgical removal of subfoveal choroidal neovascularization (CNV) and     associated hemorrhage in patients with age-related macular degeneration (AMD), the ocular     histoplasmosis syndrome (OHS), or idiopathic CNV stabilizes or improves vision more often     than observation.      To determine how surgical removal compared to observation of subfoveal CNV due to AMD, OHS,     or idiopathic causes changes the patient's perception of health- and vision-related quality     of life, as measured by telephone interview using the Medical Outcomes Survey Short Form-36     (MOS SF-36) instrument, the Hospital Anxiety and Depression Scale, and the National Eye     Institute Visual Function Questionnaire (NEI VFQ-25).      To determine whether randomized trials of surgery are warranted for patients with subfoveal     CNV associated with age-related macular degeneration not suitable for laser treatment.   "
161181|NCT00000151|"     To evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in     delaying or preventing progression of early diabetic retinopathy to more severe stages of     visual loss and blindness.      To help determine the best time to initiate photocoagulation treatment in diabetic     retinopathy.      To monitor closely the effects of diabetes mellitus and of photocoagulation on visual     function.      To produce natural history data that can be used to identify risk factors and test etiologic     hypotheses in diabetic retinopathy.   "
161182|NCT00000152|"     To determine whether 50 mg of beta-carotene taken every other day reduces the risk of     developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40     to 84 in 1982.      To investigate the possible relationship of AMD with other antioxidants, including selenium     and vitamins A, C, and E.      To identify potential risk factors for development of AMD. Possible risk factors include     height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking,     iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.   "
161183|NCT00000153|"     To evaluate whether red krypton laser treatment is as effective at causing regression of     diabetic disc neovascularization as treatment with the blue-green argon laser, when both     lasers are used with identical panretinal photocoagulation patterns.      To assess the vision of study patients.      To test the feasibility of a prototype NEI-sponsored multicenter clinical trial in which     participating clinics are not financially reimbursed and in which both the Coordinating and     Fundus Photograph Reading Center functions are carried out by staff of the NEI Biometry and     Epidemiology Program.   "
161184|NCT00000154|"     To compare two therapies, early vitrectomy and conventional management, for recent severe     vitreous hemorrhage secondary to diabetic retinopathy. Conventional management includes     vitrectomy if hemorrhage fails to clear during a waiting period of 6 to 12 months or if     retinal detachment involving the center of the macula develops at any time.      To compare early vitrectomy and conventional management in eyes that have good vision but a     poor prognosis because they are threatened with hemorrhage or retinal detachment from very     severe proliferative retinopathy.      To study the natural history of severe proliferative diabetic retinopathy.   "
161185|NCT00000155|"     To describe the clinical course of keratoconus and to describe the relationships among its     visual and physiological manifestations, including high- and low-contrast visual acuity,     corneal curvature, slit lamp biomicroscopic findings, corneal scarring, and quality of life.      To identify risk factors and protective factors that influence the severity and progression     of keratoconus.   "
161186|NCT00000156|"     To evaluate the effect of ambient light reduction on the incidence of retinopathy of     prematurity (ROP).   "
161187|NCT00000157|"     To determine whether 325 mg of aspirin taken on -alternate days reduces the risk of     developing cataract among male U.S. physicians who were aged 40 to 84 in 1982.      To identify potential risk factors for cataract development, such as age, blood pressure,     blood cholesterol, height, diabetes, medication use, and history of previous eye trauma or     surgery.   "
161252|NCT00000793|"     To assess the efficacy, safety, and tolerability of amitriptyline hydrochloride versus     mexiletine hydrochloride in reducing pain intensity in patients with HIV-related painful     peripheral neuropathy.      No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related     neuropathy have been attempted. Both amitriptyline and mexiletine have been useful in the     management of painful neuropathies; however, both are associated with certain toxicities. In     this comparative study of amitriptyline and mexiletine, benztropine mesylate also will be     included as an active placebo to mimic the side effects of the study drugs.   "
161188|NCT00000158|"     To evaluate laser treatment of choroidal neovascularization (CNV) through randomized,     controlled clinical trials. The Macular Photocoagulation Study (MPS) consisted of three sets     of randomized, controlled clinical trials. Change in best-corrected visual acuity from     baseline was the primary outcome for all MPS trials. Other measures of vision are evaluated     in each set of trials. The purpose of each is described below.      Argon Study: To determine whether argon blue-green laser photocoagulation of leaking abnormal     blood vessels in choroidal neovascular membranes outside the fovea (200 to 2,500 microns from     the center of the foveal avascular zone [FAZ]) is of benefit in preventing or delaying loss     of central vision in patients with age-related (senile) macular degeneration (AMD), presumed     ocular histoplasmosis (POH), and idiopathic neovascular membranes (INVM). A separate trial     was conducted for each of the three underlying conditions.      Krypton Study: To determine whether krypton red laser photocoagulation of choroidal     neovascular lesions with the posterior border 1 to 199 microns from the center of the FAZ is     of benefit in preventing or delaying large losses of visual acuity in patients with AMD, POH,     and INVM. A separate trial was conducted for each of the three underlying conditions.      Foveal Study: To determine whether laser photocoagulation is of benefit in preventing or     delaying further visual acuity loss in patients with new (never treated) or recurrent     (previously treated with laser photocoagulation) choroidal neovascularization under the     center of the FAZ. Two separate trials, one for each type of lesion, were carried out.   "
161189|NCT00000159|"     To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase     inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons     with insulin-dependent diabetes.   "
161190|NCT00000160|"     To determine whether photocoagulation helps prevent severe visual loss from proliferative     diabetic retinopathy.      To determine whether a difference exists in the efficacy and safety of argon versus xenon     photocoagulation for proliferative diabetic retinopathy.   "
161191|NCT00000161|"     To determine whether vitamin E supplementation reduces the risk of cataract and age-related     macular degeneration (AMD) in women.      To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women.      To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in     women.      To determine whether alternate day, low-dose aspirin reduces the risk of cataract and AMD in     women.      To identify potential risk factors for cataract and AMD including cigarette smoking, alcohol     intake, blood pressure, blood cholesterol, cardiovascular disease, height, body mass index,     and diabetes.   "
161193|NCT00000163|"     To observe the early course of congenital esotropia, a form of childhood strabismus. This     will determine the probability of spontaneous resolution. Researchers then will try to     correlate this finding with various aspects of the esotropia such as the (1) size of the     esotropia, (2) variability, and (3) presence of hyperopia. This information will be used to     determine the feasibility of conducting a clinical trial to assess the benefit of early     surgery for congenital esotropia and, if feasible, to refine eligibility criteria for the     trial.   "
161194|NCT00000167|"     To determine whether application of low-intensity laser treatment of eyes with drusen in the     macula can prevent later complications of age-related macular degeneration and thereby     preserve visual function.   "
161195|NCT00000168|"     To monitor trends over time, in the incidence of CMV retinitis and other ocular complications     of AIDS      To determine the effect of highly active anti-retroviral therapy (HAART)-induced immune     status on the risk of developing CMV retinitis and other ocular complications of AIDS      To determine the characteristics (clinical, virologic, hematologic, and biochemical) of a     population at high risk for CMV retinitis and other ocular complications of AIDS      To evaluate the effects of treatments for CMV retinitis and other ocular complications on     visual function, quality of life, and survival.   "
161196|NCT00000169|"     To compare and contrast normal eye growth, ocular component development, and refractive error     development in Hispanic, African-American, and Asian schoolchildren with what happens in     Caucasian children from the Orinda Longitudinal Study of Myopia.      To investigate risk factors for the development of myopia.      To conduct DNA-based studies on nearsighted children and their families.   "
161197|NCT00000170|"     -  To determine whether the success rate with drug treatment (atropine) of amblyopia due to          strabismus or anisometropia in patients less than 7 years old is equivalent to the          success rate with occlusion (patching) therapy        -  To develop more precise estimates of the success rates of amblyopia treatment        -  To identify factors that may be associated with successful treatment of amblyopia        -  To collect data on the course of treated amblyopia to provide more precise estimates of          treatment effects than are now available      Extended Follow up of Study Patients        -  Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15          years in patients diagnosed with amblyopia before age 7 years.        -  Secondary: To determine whether the long-term visual acuity outcome at age 10 years and          at age 15 years differs between patients who received patching followed by best clinical          care and patients who received atropine followed by best clinical care   "
161198|NCT00000721|"     To determine the maximal safe daily dose of BG8962 (rCD4) which can be administered by     continuous subcutaneous infusion (CSCI) over 24 hours; to determine the pharmacokinetics of     BG8962 when it is administered by intramuscular and subcutaneous routes; and to look for dose     related antiviral activity determined by quantitation of infectious HIV peripheral blood     leukocytes (PBLs) and plasma, and by monitoring the blood levels of viral p24 antigen (when     present), CD4+ T-cells, and Beta-2- microglobulin. Recombinant soluble CD4 protein (rCD4) is     a drug that has been produced by genetic engineering techniques. In laboratory studies, rCD4     binds to HIV and reduces its ability to enter the cell, thus inhibiting its reproduction.     Before rCD4 can be tested for therapeutic effectiveness in HIV-infected patients, it is     necessary to determine the maximum dose that can be tolerated by humans. AMENDED: To date,     Biogen's original sequence recombinant soluble CD4 and Biogen's natural sequence recombinant     soluble CD4 have both been referred to as recombinant soluble CD4 (rsCD4). In order to     distinguish between these two products, a change in nomenclature has been made. In this     protocol, whenever the original sequence CD4 molecule is referred to, it is called     recombinant soluble T4 (rsT4). Whenever the natural sequence molecule (currently under study     in this protocol) is referred to, it is called BG8962 or rCD4. Whenever the drug is discussed     generically, it is referred to as rsCD4.   "
161199|NCT00000722|"     To compare the use of pentamidine aerosol (inhaled mist) with the standard intravenous method     of administration in patients with AIDS related Pneumocystis carinii pneumonia (PCP), to     measure the amount of pentamidine aerosol that actually reaches the lung, and to see if close     clinical observation is safer and as effective as drug therapy in the prevention of PCP     recurrences. To compare the efficiency of 2 nebulizers - the Respirgard II nebulizer and the     Cadema Aerotech II nebulizer. Aerosolized pentamidine was as effective as intravenous     pentamidine in treating PCP in animals. More of the pentamidine reached the lungs and less     was found in the liver and kidney after pentamidine was given by aerosol than after an     intravenous injection. This suggests that the toxicity of pentamidine may be less if given by     aerosol than if given by the intravenous route.   "
161200|NCT00000723|"     To determine the safety and toxicity of high-dose systemic methotrexate (MTX) and     dexamethasone (DEX) combined with zidovudine (AZT) and brain irradiation in patients with     AIDS-related primary central nervous system (CNS) lymphoma and to determine response rates     and survival of treated patients. Also to determine if the treatment inhibits HIV replication     in patients who are HIV culture and/or antigen positive and to assess the incidence of     opportunistic infection in these patients Results of radiation given to patients with     AIDS-related high-grade CNS lymphoma have been disappointing, with short survival times due     to infection complications. However, complete response has been documented after radiation in     some patients. High-dose MTX will be used to improve the possibility of a greater     antineoplastic response than that obtained by radiation alone. Since the underlying     immunodeficiency state is not affected by therapy directed against the lymphoma, patients are     still prone to life-threatening opportunistic infections or relapse of lymphomatous disease     within the CNS. Accordingly, AZT will also be used in an attempt to alter the overall natural     history of the disease.   "
161217|NCT00000740|"     To determine the maximum tolerated dose (MTD) of WR 6026 in HIV-infected patients. To     determine whether any unexpected toxicities are caused by WR 6026 in HIV-infected patients.     To determine whether there is additional toxicity when WR 6026 is given for 21 days rather     than 14 days. To further investigate the pharmacokinetics and pharmacodynamics of WR 6026,     and in particular to examine potential correlations between the area under the     concentration-time curve and methemoglobinemia or other toxicities.      In recent animal studies, WR 6026 demonstrated inhibitory activity against Pneumocystis     carinii pneumonia (PCP). This study will assess the safety and tolerance of this drug in     HIV-infected patients who do not have PCP.   "
161201|NCT00000724|"     To study the safety and effectiveness of trimetrexate (TMTX) plus leucovorin calcium rescue     (LCV) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS,     patients who are HIV positive, or those for whom laboratory confirmation of HIV infection has     not yet been established if they are at high risk for HIV infection, and who have not     responded to standard treatments or who have demonstrated severe or life-threatening     intolerance to both conventional therapies for PCP.      The drugs trimethoprim / sulfamethoxazole (TMP / SMX) and pentamidine, usually used to treat     PCP in AIDS patients, have proven ineffective in many patients and have had to be     discontinued in many other patients because of severe side effects. TMTX was chosen for this     trial because it was found to be very active against the PCP organism in laboratory tests     and, in a preliminary trial in combination with LCV, there was a high response rate without     severe toxicity.   "
161202|NCT00000725|"     To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's     sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon     alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics     of both AZT and IFN-A or IFN-A2A when given in combination; to define the maximum tolerated     dose of each drug in combination and to define doses to be used in Phase II trials. AZT has     been found to inhibit both the in vitro (in test tube) and cell killing effects of HIV, and     both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in Kaposi's     sarcoma. It is reasonable to assume that a synergistic effect and enhanced antitumor response     may be seen with combination therapy. A study to evaluate the safety and efficacy of AZT in     combination with IFN-A or IFN-A2A is warranted.   "
161203|NCT00000726|"     To explore the safety and usefulness of foscarnet, an antiviral agent, in the treatment of     cytomegalovirus (CMV) retinitis. Untreated CMV retinitis is a rapidly progressive, blinding     disease in AIDS patients. The manner in which foscarnet breaks down in the body and the     effect of increasing periodic intravenous doses are also studied. Foscarnet is active in     vitro (test tube) against herpes viruses, including CMV, by inhibiting the virus DNA     polymerases, enzymes necessary for virus replication, without affecting cellular DNA     polymerases. Opportunistic CMV disease in AIDS is usually seen as retinitis, colitis,     esophagitis, hepatitis, pancreatitis, encephalitis, or pneumonia. Ganciclovir has been used     to treat AIDS patients with CMV disease but can cause severe neutropenia (very low neutrophil     cell counts). Foscarnet does not suppress the production of neutrophils or other leukocytes     (myelosuppression) and has shown in vitro activity against HIV.   "
161204|NCT00000727|"     To determine if the drug combination sulfamethoxazole-trimethoprim (SMX-TMP), given by mouth,     and the drug pentamidine (PEN), given by inhaled aerosol, are effective in preventing a     relapse of Pneumocystis carinii pneumonia (PCP) when they are given to patients who have     recovered from a first episode of PCP and are being given zidovudine (AZT) to treat primary     HIV infection.      AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic     infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT,     indicating a need for other treatments to reduce the relapse rate.      The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been     partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT     with these medications will be more effective than AZT or one of the medications alone.   "
161253|NCT00000794|"     To evaluate the efficacy, safety, and tolerance of atovaquone with either pyrimethamine or     sulfadiazine in AIDS patients with toxoplasmic encephalitis.      AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of     sulfadiazine and pyrimethamine experience a high frequency of severe toxicity. Atovaquone, an     antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in     preclinical testing has been well tolerated, is now available as a suspension, which is more     readily absorbed than the tablet form of the drug. The efficacy and safety of atovaquone in     combination with sulfadiazine or pyrimethamine will be studied.   "
161205|NCT00000728|"     To evaluate the short-term effects of administering zidovudine ( AZT ) at the same time with     increasing doses of aldesleukin ( interleukin-2; IL-2 ) in patients with persistent     generalized lymphadenopathy syndrome ( PGL ). The effects to be studied include safety or     toxicity, how quickly the drugs are used in the body, effects on the immune system, effects     on HIV, concentrations in body fluids, and how quickly the drugs are cleared by the kidneys.     The trial will establish the maximum tolerated dose ( MTD ) and will be a pilot study to     determine the dose that has the greatest effect in the immune system.      AZT has been shown to be effective in HIV-related disease. IL-2 has been shown to increase     immune responses and correct immune problems caused by HIV in the test tube. IL-2 has also     been effective in treating Kaposi's sarcoma in a number of patients. Because of the clinical     activities of these two drugs and because their toxicities and mechanisms of action do not     overlap, it may be beneficial to combine the two drugs with their antiviral and immune     stimulatory effects.   "
161206|NCT00000729|"     To determine the toxicity of low dose foscarnet administered for 4 weeks to HIV infected     patients who are asymptomatic, have AIDS, or other HIV associated conditions and a CD4+     lymphocyte count < 500 cells/mm3. To obtain preliminary efficacy data. Although zidovudine     (AZT) has been effective in treating some AIDS patients, AZT has toxic effects in many     patients and other means of treating HIV-infected persons need to be evaluated. In vitro     (test tube) studies have shown that the human herpes viruses are inhibited by foscarnet and     that a number of retroviruses, including HIV, are sensitive to it. It is hoped that treatment     of HIV-infected individuals with foscarnet during an early phase of HIV infections will     reduce the risk of developing AIDS.   "
161207|NCT00000730|"     This study compares three different therapies for treatment of refractory Pneumocystis     carinii pneumonia (PCP) in patients with AIDS. Refractory means that the patient has failed     to respond to at least 4 days of treatment with either of two standard therapies: (1)     sulfamethoxazole/trimethoprim (SMX/TMP) or (2) pentamidine (PEN). This study compares therapy     with trimetrexate (TMTX) and leucovorin (LCV) to standard therapy and standard therapy plus     high-dose steroids (methylprednisolone). The purpose is to find better and safer forms of     treatment for PCP in AIDS patients. There is at present no scientific information about the     best treatment for an AIDS patient with PCP who is not improving while receiving the standard     therapies (SMX/TMP or PEN). New drug treatments are available, including steroid therapy and     TMTX, but there is no information proving that these new treatments work better than the     standard therapies.   "
161208|NCT00000731|"     To determine if zidovudine (AZT) and acetaminophen (APAP) interact when given to the same     patient, and if so, the manner of interaction. Patients with AIDS often require therapy with     painkillers for the management of mild pain and discomfort associated with their disease, and     APAP is often prescribed. AZT is being used to treat AIDS patients. It is important for     doctors to understand how AZT and APAP may interact when given to the same patient, because     other studies have suggested that the dosage of AZT may have to be adjusted when given with     APAP in order to avoid or minimize adverse effects.   "
161209|NCT00000732|"     To determine if the pharmacokinetics of low doses of zidovudine (AZT) (that is, how fast AZT     reaches the blood, what concentration of AZT is attained in the blood, and how long AZT     remains in the blood) changes from day-to-day in the same patient. Also to determine whether     the pharmacokinetics of AZT is changed by sulfamethoxazole/trimethoprim (SMX/TMP) given at     the same time or whether the pharmacokinetics of SMX/TMP is altered by AZT therapy. AZT has     been effective in treating some patients with AIDS, and SMX/TMP is an antibiotic combination     which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP), which is an     important cause of disease and death in patients with AIDS. It is important to know how drugs     interact in patients because addition of a second drug may change the speed at which a drug     is eliminated from the body, and cause increased toxic effects or decreased therapeutic     effects.   "
161210|NCT00000733|"     To determine how fast ribavirin reaches the bloodstream, what concentration of ribavirin is     reached in blood and how long it remains in the blood (pharmacokinetics) when given by     different routes of administration. To find the maximum tolerated dose (MTD) of ribavirin.     The effects of ribavirin on the immune system, and on the virus will be measured by T4 cell     count and p24 antigen levels.      Early studies with ribavirin in patients with AIDS and AIDS related complex (ARC) have shown     that ribavirin appears to inhibit the spread of the virus. Determination of how much and how     often to give the drug will require further knowledge of the pharmacokinetics and toxicity of     the drug in patients with AIDS or ARC and in chronic virus carriers who do not have symptoms.   "
161211|NCT00000734|"     To determine if the pharmacokinetics of high doses of zidovudine (AZT) (that is, how fast AZT     reaches the blood, what concentration of AZT is attained in the blood, and how long AZT     remains in the blood) changes from day to day in the same patient. Also to determine whether     the pharmacokinetics of AZT is changed when trimethoprim/sulfamethoxazole (SMX/TMP) is given     at the same time, or whether the pharmacokinetics of SMX/TMP is altered by AZT given at the     same time.      AZT has been effective in treating HIV infection in some patients with AIDS, and SMX/TMP is     an antibiotic combination which is useful in preventing or treating Pneumocystis carinii     pneumonia (PCP). It is important to know how drugs interact in patients because addition of a     second drug may change the speed at which a drug is eliminated from the body, and cause     increased toxic effects or decreased therapeutic effects.   "
161212|NCT00000735|"     To determine the safety of intravenous infusion of ampligen in symptomatic HIV-infected     patients at several dose levels, to determine the maximum dose that can be tolerated, and to     measure the effects of ampligen on the HIV virus infection, immune function, and clinical     condition. Ampligen is a suitable drug for clinical trials against HIV because it has been     shown to stimulate the immune system and to inhibit replication of HIV in vitro at doses that     can be achieved without noticeable harmful side effects.   "
161213|NCT00000736|"     To determine if treatment with zidovudine (AZT) will delay or prevent the onset of AIDS or     AIDS related complex (ARC) in individuals infected with HIV but who do not have symptoms of     AIDS or ARC. Also, to compare the dose of AZT found to be useful in AIDS and severe ARC with     a lower dose to see if side effects can be reduced.      Results from several studies show that a high percentage of people infected with HIV will     eventually develop AIDS or ARC unless an effective treatment is found. Because AZT is known     to prolong survival in patients with AIDS or severe ARC and has acceptable toxicity in     advanced disease, it is reasonable to try it in less advanced cases.   "
161214|NCT00000737|"     To obtain data on the safety of administering megestrol acetate and dronabinol as single     agents or in combination to patients with human immunodeficiency virus (HIV)-wasting     syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy     with megestrol acetate and dronabinol with regard to weight gain, appetite increase and     quality of life in this patient population. To obtain steady-state pharmacokinetics data when     megestrol acetate and dronabinol are administered as single agents and in combination.      HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight     loss, is of particular concern because it can exacerbate the primary illness and is     associated with a poor prognosis. Attempts at maintaining body mass through the use of     megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.   "
161215|NCT00000738|"     PRIMARY: To assess the safety of nimodipine in the treatment of HIV-Associated Motor /     Cognitive Complex (formerly AIDS dementia complex). To assess the systemic or central nervous     system toxicities (e.g., rash, headache, gastrointestinal symptoms, nausea, dyspnea, muscle     pain or cramp, acne) of nimodipine.      SECONDARY: To assess the efficacy of nimodipine in stabilizing the progression of     HIV-Associated Motor / Cognitive Complex by improvement in neuropsychological test     performance, peripheral neuropathy, or other neurologic manifestations.      HIV-infected patients may develop a condition known as HIV-Associated Motor / Cognitive     Complex (also known as AIDS dementia complex) that causes damage to the nervous system,     particularly the brain and spinal cord. Evidence exists that nimodipine protects nerve cells     in culture from injury by HIV. Although nimodipine has been used in patients with other     neurological problems, its safety and effectiveness in halting the progression of     HIV-Associated Motor / Cognitive Complex is not yet known.   "
161216|NCT00000739|"     Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and     children; to study the pharmacokinetics of orally administered dapsone in HIV-infected     infants and children.      Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP )     breakthrough in children receiving two different dose regimens of dapsone.      Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected     children considered to be at high risk. Approximately 15 percent of children are intolerant     to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many     children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second     choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been     established.   "
161218|NCT00000741|"     To determine the effect of methylprednisolone on respiratory failure in HIV-infected patients     with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or     absence of respiratory failure at the time of randomization to the study.   "
161472|NCT00000459|"     To assess the feasibility, acceptability, efficacy, and safety of dietary intervention in     free-living children ages 8-10 with elevated low density lipoprotein cholesterol levels.   "
161219|NCT00000742|"     Part I: To determine the pharmacokinetic dose for atevirdine mesylate ( U-87201E ) when used     in combination with zidovudine ( AZT ). To determine the pharmacokinetic profiles of U-87201E     and AZT over a 12-week period.      Part II: To determine whether or not decreased viral susceptibility to U-87201E develops when     the drug is administered concomitantly with AZT for 12 weeks.      Part III: To evaluate the pharmacokinetic effects of ddI/AZT/U-87201E therapy and to assess     changes in viral susceptibility to U-87201E.      Interest exists in the development of antiretroviral agents that possess different mechanisms     of action from nucleoside analogs such as AZT. U-87201E is a non-nucleoside reverse     transcriptase (RT) inhibitor that has demonstrated activity against HIV-1; however, an     emerging characteristic of non-nucleoside RT inhibitors is the development of rapid     resistance to HIV isolates. Whether this resistance can be prevented in the presence of     nucleoside analogs such as AZT and ddI has yet to be determined.   "
161220|NCT00000743|"     To determine the safety and tolerance of alvircept sudotox (sCD4-PE40) given at various     dosing intervals and concentrations. To determine whether frequent dosing alters     immunogenicity or toxicity. To obtain preliminary data to ascertain whether sCD4-PE40 has     activity against HIV in human subjects. To determine whether there is any additive toxicity     with combined use of sCD4-PE40 and zidovudine (AZT).      There is some evidence that AZT and sCD4-PE40, an experimental drug with anti-HIV activity     previously demonstrated in vitro, may produce increased benefit when used in combination in     HIV-infected patients.   "
161221|NCT00000744|"     To compare the efficacy of fluconazole versus placebo for the prevention of Candida     esophagitis and vaginal/oropharyngeal candidiasis, including a comparison of the development     of clinical resistance.      Fluconazole has been shown to be effective in preventing or suppressing candidiasis in     HIV-negative women. An increasing likelihood of oral and esophageal candidiasis in     conjunction with progressive immunosuppression raises the question of the potential role of     prophylactic antifungal therapy in high-risk persons.   "
161222|NCT00000745|"     To determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160. To     determine the immunogenicity of gp160.      Although recent advances have been made in antiviral therapy against AIDS, there is currently     no cure. It is likely that ultimate control of the disease will depend on the development of     safe and effective vaccines against HIV.   "
161223|NCT00000746|"     Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160     envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit     recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity     compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts     with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two     priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity     of the three subunit vaccines when administered as boosters.      Secondary: To examine the safety of administering the individual subunit vaccines in     combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone.      In a previous study of candidate HIV vaccines, the evidence suggested that administration of     a booster vaccination with a different vaccine preparation may produce a better immune     response than administration of HIVAC-1e vaccine alone.   "
161520|NCT00000507|"     To determine whether the administration of intravenous streptokinase (SK) early in the course     of acute, transmural myocardial infarction would limit myocardial damage.   "
161224|NCT00000764|"     PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in     combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in     efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention     (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous     intraepithelial lesions ( SIL ) in patients with HIV infection.      SECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a     on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels.      Patients with HIV infection have a significant risk of recurrence following local ablation of     intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important     cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of     non-HIV-infected subjects have established that synthetic retinoids inhibit the progression     of epithelial preneoplastic conditions and some neoplastic states.   "
161225|NCT00000765|"     To evaluate the safety and efficacy of early treatment with zidovudine for preventing a     decline in CD4+ lymphocyte counts in patients with primary HIV infection. To determine the     natural history of virologic and immunologic changes in primary HIV infection.      Previous studies indicate that intervention with zidovudine during primary HIV infection     could reduce the initial viral burden and subsequent decline in immune functions, and could     prolong not only the time to development of AIDS but also the time to initiation of chronic     antiretroviral therapy.   "
161226|NCT00000766|"     To assess the safety and efficacy of three therapeutic regimens (foscarnet, ganciclovir, or     the combination) for recurrent or persistent AIDS-related cytomegalovirus (CMV) retinitis.      Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of     patients treated, relapses are common and may accelerate due to development of drug     resistance, deteriorating immune function, or other factors. Treatment strategies currently     being investigated include switching patients from one drug to the other or combining the two     drugs.   "
161227|NCT00000767|"     To evaluate, in healthy HIV-1 seronegative vaccinia-immune and vaccinia-naive volunteers, the     safety and immunogenicity of an HIV-1 candidate vaccine (TBC-3B) consisting of a live     recombinant vaccinia virus expressing the env, gag, and pol genes of HIV-1 IIIB strain. To     evaluate the potential of boosting with one of a variety of HIV-1 recombinant subunit,     peptide, or pseudovirion vaccines, if available, to augment the immune responses of the     vaccinees.      Antigenic drift, defined as the genetic variation of the HIV-1 envelope gene that results in     antigenic variation during natural infection, may confound attempts to achieve protective     immunity using a vaccine based solely on HIV-1 envelope proteins. Inclusion of conserved core     and polymerase proteins along with envelope protein in a candidate vaccine may address some     of the problems with antigenic variability. A prime-boost immunization approach using a novel     priming immunogen expressing env, gag, and pol genes of the HIV-1 IIIB strain will be     attempted in this study.   "
161258|NCT00000799|"     To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for     treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the     relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.   "
161228|NCT00000768|"     To determine the oral bioavailability of three dose levels of oral ganciclovir given with and     without glutamic acid hydrochloride in patients with cytomegalovirus (CMV) GI disease, and to     compare the bioavailability of these regimens to that of standard intravenous (IV)     ganciclovir.      Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis     following induction treatment. Oral ganciclovir is a likely candidate for maintenance because     of its possible therapeutic value and ease of administration, but an optimum dose has not     been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an     acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal     absorption of this drug.   "
161229|NCT00000769|"     To determine the safety and tolerance of interleukin-4 (IL-4) in patients with AIDS-related     Kaposi's sarcoma. To determine the effects of IL-4 on tumor growth in patients with     AIDS-related Kaposi's sarcoma.      IL-4 exhibits a variety of beneficial effects on the immune system and is a potent inhibitor     of Kaposi's sarcoma cells in vitro.   "
161230|NCT00000770|"     To assess the safety and toxicity of zidovudine (AZT)/didanosine (ddI) versus AZT/ddI     combined with nevirapine in HIV-infected patients, and to obtain preliminary anti-HIV     activity data using immunologic and virologic markers.      Previous in vitro studies suggest that HIV that has already developed resistance to AZT and     ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase     inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected     patients may prove more effective.   "
161231|NCT00000771|"     To determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in     the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of     oral paromomycin at two different doses. To explore whether paromomycin administered over a     longer period provides additional benefit.      In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with     paromomycin therapy.   "
161232|NCT00000772|"     To evaluate the safety and tolerance of concurrent administration of standard-dose didanosine     (ddI) with low-dose ribavirin in HIV-positive patients. To determine the pharmacokinetic     interactions of concurrent administration of ddI and ribavirin and correlate pharmacokinetic     parameters with toxicity. To investigate antiviral activity of the combined regimen.      Combination ddI/ribavirin therapy, if safe and effective, offers an alternative combination     antiretroviral regimen for patients unable to tolerate regimens containing zidovudine (AZT).   "
161233|NCT00000773|"     To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate     suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94     amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally     exposed (per 8/9/95 amendment) infants and children who are at risk of developing     Pneumocystis carinii pneumonia (PCP).      Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly     absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has     been prepared as a microparticulate suspension. Since studies in adults have demonstrated     substantial safety of this drug, evaluation in children is being pursued.   "
174821|NCT00129961|"     The purpose of this study is to determine the effect of sirolimus on the prevention of new     non-melanoma skin cancer (NMSC) in kidney transplant recipients.   "
161234|NCT00000774|"     PRIMARY: To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech)     and rgp120/HIV-1SF2 (Chiron/Biocine) in infants who are of indeterminate HIV status born to     HIV-infected women. To evaluate changes in viral load in infants proven to be infected and     absolute CD4 counts in all immunized infants.      SECONDARY: To evaluate the immunogenicity of these envelope recombinant proteins in infants     of indeterminate HIV status born to HIV-infected women.      Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early     sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may     enhance HIV-specific immune function to alter HIV replication and disease progression.   "
161235|NCT00000775|"     To determine the safety, immunogenicity, and optimal dose of rgp120/HIV-1MN octameric V3     peptide vaccine (SynVac) in healthy volunteers.      It is likely that the ultimate control of AIDS will depend on the development of safe and     effective vaccines against HIV-1. SynVac is a synthetic candidate vaccine based on eight     V3-derived peptides attached to a heptalysyl core to form radial octamers. In animal studies,     the vaccine appears safe and demonstrates the capability for producing immune responses.   "
161236|NCT00000776|"     To evaluate the effect of corticosteroids on reducing elevated intracranial pressure in     cryptococcal meningitis. To evaluate the safety of corticosteroids in patients with     cryptococcal meningitis and intracranial hypertension.      In AIDS patients with cryptococcal meningitis, a correlation has been found between early     death and elevated intracranial pressure. Since dexamethasone has been found to reduce     intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS     patients with cryptococcal meningitis.   "
161237|NCT00000777|"     To evaluate the safety of gp160 vaccine (VaxSyn) in HIV-1 infected pregnant women with CD4     counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and     the passive acquisition of vaccine-specific antibody in their infants.      Evidence suggests that an advanced stage of disease with high plasma viremia is associated     with increased transmission of HIV-1 to the fetus. Slowing the progression of disease,     reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody     are potentially attainable goals through active immunization of the mother during pregnancy.   "
161238|NCT00000778|"     To evaluate the methodology for rapidly determining the early bactericidal activity (EBA),     tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary     tuberculosis (TB).      Traditionally, in trials for treatment of TB, a new drug is administered in combination with     two or more other antituberculous agents of known effectiveness over a long period of time.     In this setting, it is difficult to determine the effect of any single drug or dose level.     Development of new agents for the treatment of TB may be accelerated by a methodology in     which a new agent could be evaluated for activity by administering it as a single agent over     a short time period. This study utilizes a method to measure the amount of bacteria present     each day in the lungs.   "
161473|NCT00000460|"     To determine the effects of high or low intensity long-term exercise conditioning in patients     with coronary artery disease.   "
162165|NCT00002035|"     To compare the efficacy and safety of orally administered didanosine (ddI) with orally     administered zidovudine (AZT) in the treatment of patients who exhibit increasing clinical     deterioration despite treatment with AZT.   "
161239|NCT00000779|"     PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens     versus control in HIV-infected individuals with CD4 counts greater than or equal to 500     cells/mm3.      SECONDARY: To determine whether significant advantages to any one vaccine exist.      Before large clinical trials of anti-HIV vaccines are undertaken, it is important to     determine whether there are significant advantages to any one of the vaccines currently     offered for such studies.   "
161240|NCT00000780|"     PRIMARY: To identify, characterize, and co-enroll HIV-infected adolescents into existing and     future ACTG (or other NIH-sponsored) HIV treatment protocols through the systematic and     recurrent assessment of eligibility. To assess the ability of adolescents enrolled in ACTG     220 to adhere to ACTG (or other NIH-sponsored) HIV treatment protocols; and to define factors     that influence the adolescent's ability to enter or adhere to study protocols.      SECONDARY: To describe the nature, stage, and progression of HIV infection in adolescents.      Little is known about HIV-infected adolescents as a group and, as a result, small numbers of     them are currently enrolled in ACTG drug studies. Creative approaches are needed to encourage     enrollment of HIV-infected adolescents whose socio-demographic profile has made access to     NIH-sponsored research unlikely.   "
161241|NCT00000781|"     To determine the relative clinical efficacy of zidovudine ( AZT ) plus didanosine (ddI), AZT     plus zalcitabine ( ddC ), AZT alternating monthly with ddI, and AZT/ddI plus nevirapine in     HIV-infected patients with advanced disease.      The rapid emergence of resistant HIV strains has been observed in patients receiving     monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use     of combination therapy with two nucleoside drugs or convergent combination therapy with two     nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant     HIV strains. Since toxicity is a major problem in patients with advanced disease who are     receiving combination nucleoside therapy, alternating the two drugs may provide a way of     retaining several benefits of combination therapy while minimizing the increased toxicity.   "
161242|NCT00000782|"     To determine the frequency of delayed-type hypersensitivity (DTH) reactions in HIV-positive     patients to two doses of two envelope glycoprotein antigens prepared differently. To     determine whether patients who have previously demonstrated a DTH response to intradermal     MGStage HIV-1 gp160 IIIB baculovirus (MicroGeneSys) have a reproducible response to a repeat     injection of gp160 and whether there is cross-reactivity to intradermal HIV-1 rgp160 IIIB     vero cell expressed (Immuno-AG).      PER 4/5/95 AMENDMENT: To also determine whether patients who respond to HIV-1 rgp160 IIIB     baculovirus (MicroGeneSys) have cross-reactivity to intradermal skin tests of HIV-1 rgp160 MN     (Immuno-AG).      Previous studies in individuals immunized with gp160 suggest that a skin test response in     immunized patients can be used as a surrogate marker for new proliferative and cytotoxic     responses induced by vaccination.   "
161521|NCT00000508|"     To determine whether modification of risk factors altered the rate of progression of coronary     artery disease in arteries with mild atherosclerosis and no mechanical intervention in     patients who had coronary bypass surgery or percutaneous transluminal coronary angioplasty     (PTCA).   "
161243|NCT00000783|"     PRIMARY: To identify sexual behaviors and biological factors associated with an increased     risk of heterosexual HIV transmission.      SECONDARY: To assess the effect of safer sex counseling on behavior of sexually active     heterosexuals in which one member of the couple is infected with HIV. To create a repository     of serum, peripheral blood mononuclear cells, semen, and cervico-vaginal washings from     heterosexual couples who are concordant (both partners HIV infected) and discordant (one     partner HIV infected) with respect to HIV infection.      In the United States, the number of AIDS cases attributed to heterosexual transmission,     although still a small percentage of the total number of reported cases, is the most rapidly     growing category. The rate at which HIV is transmitted between heterosexual couples and the     factors that may impede or enhance heterosexual transmission are important to understanding     and slowing the worldwide HIV epidemic.   "
161244|NCT00000784|"     To examine, in patients enrolled in protocols CPCRA 006 and/or 007, the relationship between     patient compliance and demographic, psychosocial, and lifestyle characteristics and Health     Belief Model premises (i.e., patient's perception of susceptibility to and severity of     disease and perception of benefits and barriers to a particular treatment) in order to design     more effective intervention protocols.      Patient noncompliance can influence the statistical findings of a clinical study, possibly     resulting in an incorrect assessment of the effects of the investigational therapeutic agent.     Since the special populations targeted by the CPCRA for inclusion in HIV-related clinical     research do not typify those traditionally included in clinical trials or compliance     research, it is necessary to elucidate and examine the special needs of these populations and     to determine the extent to which these needs manifest themselves as potential barriers to     protocol compliance.   "
161245|NCT00000785|"     PRIMARY: To estimate the proportion of tuberculosis patients in the CPCRA who have     drug-resistant tuberculosis (TB) and to describe the patterns of drug resistance.      SECONDARY: To compare drug resistance data on the Mycobacterium tuberculosis isolates of     HIV-infected patients to those of HIV-uninfected patients who are being followed in the     CPCRA. To assess the relationship of resistance data with geographic, demographic, and HIV     and TB risk factor information.      Geographic areas and demographic subgroups affected by the TB epidemic appear to be congruent     and associated with the concurrent HIV epidemic. The total number of CPCRA patients who will     develop, or who have experienced, confirmed TB is unknown. It is critical to determine the     depth and breadth of the current problem of drug-resistant TB.   "
161246|NCT00000787|"     PRIMARY: To identify factors associated with risk of HIV infection through heterosexual     activity among urban, inner-city women.      SECONDARY: To identify correlates of high-risk behaviors in order to provide a basis for     future intervention studies.   "
161247|NCT00000788|"     To evaluate the pharmacokinetics and safety of concomitant administration of methadone and     fluconazole.      Injection drug users constitute the second largest subset of the U.S. population at risk for     HIV infection and AIDS-associated mortality. Narcotic addiction is often treated by use of     methadone. Fluconazole has been shown to be highly effective in treating symptomatic mucosal     candidiasis, but it is unknown whether fluconazole affects methadone metabolism, which could     result in symptoms of methadone withdrawal or overdose in patients taking the drugs in     combination.   "
161533|NCT00000520|"     To test the efficacy of intravenous gamma globulin (IVGG) in preventing coronary artery     aneurysms in children with Kawasaki Syndrome.   "
161534|NCT00000521|"     To examine the effects of nutritional intervention on the rate of rise of blood pressure in     late childhood and early adolescence.   "
161248|NCT00000789|"     PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral     stavudine (d4T) in symptomatic HIV-infected children.      SECONDARY: To compare the clinical, virologic, and immunologic responses between the two     treatment groups, and to obtain pharmacokinetic data for both drugs.      At present, AZT is considered the drug of choice for initial treatment of most children with     HIV infection, although disease progression or drug intolerance is associated with its     long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well     tolerated, although an optimum dose has not been determined.   "
161249|NCT00000790|"     PRIMARY: To evaluate the effectiveness and safety of thalidomide for treatment of oral and     esophageal aphthous ulcers (those unrelated to a known infection or malignancy) in patients     with advanced HIV disease. To evaluate the effect of thalidomide on HIV load in this patient     population. Per 06/28/94 amendment, to evaluate the effectiveness of thalidomide in     preventing recurrences in patients whose aphthae completely heal at the end of acute     treatment.      SECONDARY: To evaluate the effect of thalidomide on blood tumor necrosis factor (TNF) levels     and to obtain pharmacokinetic data on the drug. Per 06/28/94 amendment, to evaluate the     safety of thalidomide. Per 05/10/95 amendment, to explore in a substudy the effects of     thalidomide on idiopathic genital aphthous ulcers in HIV-infected women.      Aphthous ulcers of the mouth or esophagus can interfere with eating, resulting in     malnutrition and wasting. Thalidomide has been proposed as an effective therapy for severe     forms of aphthous ulceration in AIDS patients.   "
161250|NCT00000791|"     To determine the safety and anti-HIV activity of two doses of SC-49483 in combination with     zidovudine (AZT) versus AZT alone. To determine the influences of viral phenotype on the     anti-HIV activity of these treatment regimens.      SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to     SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less     gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the     benefits of both drugs in patients with HIV infection.   "
161251|NCT00000792|"     To determine the safety and tolerance of daily oral hypericin when given to achieve target     trough levels within defined cohorts. To determine the responses of surrogate markers of HIV     infection to daily oral hypericin.      It is not known whether daily oral dosing will produce a tolerable prolonged exposure to     therapeutic levels of hypericin. Pharmacokinetic modeling studies have demonstrated that     daily oral dosing should produce a trough level in a desired range without excessive peak     levels.   "
161266|NCT00000807|"     To assess the toxicity, tumor response rate, and effect on quality of life of daily low-dose     etoposide administered for 7 consecutive days every other week in patients with AIDS-related     Kaposi's sarcoma that has relapsed or progressed after systemic chemotherapy.      Etoposide may be at least as, or even more, effective and less myelotoxic when given in low     doses over prolonged periods of time.   "
161254|NCT00000795|"     To evaluate, in healthy adult volunteers, the safety and immunogenicity of multivalent HIV-1     peptide immunogen, a formulation of HIV-1 gp120 principal neutralizing domain (PND) branched     synthetic peptides from 15 viral strains representative of diverse worldwide isolates.      Because there is considerable variation among HIV-1 virus strains from differing geographical     locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent     and divergent isolates, potentially providing for wide coverage of geographically isolated     epidemics.   "
161255|NCT00000796|"     To determine the demographic, behavioral, clinical, and geographic risk factors associated     with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the     clinical and microbiological responses and overall survival of MDRTB patients who are treated     with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per     9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of     patients who show failure or relapse are due to the same strain or reinfection with a new     strain.      Among TB patients, there has been an increase in progressive disease due to the emergence of     antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify     patients at high risk for MDRTB increases the hazard for both treatment failure and     development of resistance to additional therapeutic agents. Efforts to improve survival in     patients with MDRTB will depend on improved methods of assessing the risk of acquisition of     MDRTB and identifying drug susceptibility patterns in a timely fashion.   "
161256|NCT00000797|"     The Women's Interagency HIV Study (WIHS), a multicenter, prospective study, was established     in August 1993 to carry out comprehensive investigations of the impact of HIV infection and     its clinical, laboratory, and psychosocial effects in women. The purpose of this study is to     collect and evaluate these data from HIV infected and at-risk women to better understand and     provide support for women whom are currently HIV infected or who are at risk for HIV     infection.   "
161257|NCT00000798|"     To evaluate the safety and immunogenicity of a new microparticulate formulation of an HIV-1     MN PND peptide for oral administration in healthy, HIV-1 seronegative adult volunteers at low     risk for infection.      Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite     characteristics of an effective HIV vaccine, such as induction of mucosal immunity,     production of cytotoxic T cells, and ease of administration. An oral microparticulate vaccine     containing a prototype synthetic peptide has been developed. The microparticles can be     degraded over time, inducing both secretory and systemic immune responses.   "
161535|NCT00000522|"     To compare the effects of nonpharmacologic therapy alone with those of one of five active     drug regimens combined with non-pharmacologic therapy, for long- term management of patients     with mild hypertension.   "
161259|NCT00000800|"     To determine whether methadone maintenance alters the pharmacokinetics of zidovudine (AZT).     To determine whether any such effect of methadone on disposition of AZT is time dependent and     whether a metabolic interaction between AZT and methadone exists.      Injection drug users represent an increasing proportion of HIV-infected persons. Since daily     methadone maintenance is the major chemical treatment for injection drug abuse, it is     important to determine the impact of methadone on AZT absorption, distribution, and     elimination.   "
161260|NCT00000801|"     To estimate the response rate, overall and disease-free survival, toxicities, factors     associated with outcome, and effect on quality of life in patients with AIDS-related primary     CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and     dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external     beam irradiation. To determine other clinical markers present in this patient population.      Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS     lymphoma.   "
161261|NCT00000802|"     To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the     onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected     patients with CD4 counts <= 200 cells/mm3 or <= 15 percent of the total lymphocyte count who     are intolerant to trimethoprim and/or sulfonamides.      Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is     associated with allergic manifestations and side effects that limit its use. Patients who are     intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both     shown promise as PCP prophylactic agents.   "
161262|NCT00000803|"     To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in     combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination.      U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either     AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy     appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use     of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in     persons with HIV disease.   "
161263|NCT00000804|"     The purpose of this trial is to study L-735,524, which is an inhibitor of the HIV protease     enzyme. It will be used with interleukin-2 in patients infected with HIV.   "
161264|NCT00000805|"     PRIMARY: To determine the pharmacokinetics, MTD, and long-term safety and tolerance of oral     ganciclovir in HIV-infected infants, children, and adolescents.      SECONDARY: To evaluate the effect of oral ganciclovir on the virologic parameters of CMV.      Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS     patients is now standard therapy, but daily IV therapy can be complicated by catheter     infections and thrombosis. An oral regimen of ganciclovir has been administered safely in     adult AIDS patients and may be of significant benefit to children and infants as well.   "
161265|NCT00000806|"     PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two     dose regimens and formulations of SC-52151.      SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the     relationship between day 14 plasma concentrations of SC-52151 and immunological and     virological markers and toxicity.      Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur     in vitro after multiple passages, and since prolonged post infectious effects occur in vitro,     comparison of two formulations, an elixir and a self-emulsifying drug delivery system     (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.   "
161522|NCT00000509|"     To examine the role of dietary sodium reduction with and without potassium supplementation in     controlling blood pressure in hypertensive men.   "
161267|NCT00000808|"     To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of     nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to     the mother during active labor, and when their neonates are dosed during the first week of     life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who     received nevirapine during active labor, and their neonates who received no dose, a single     dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of     life.      Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic     levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition,     decreasing the neonate's risk of infection.   "
161268|NCT00000809|"     The purpose of this study is to test the safety and effectiveness of two different     formulations of an HIV vaccine in infants born to HIV-infected women.   "
161269|NCT00000810|"     PRIMARY: To study the safety and tolerance of delavirdine mesylate ( U-90152 ) monotherapy.     To compare the anti-HIV activity of three blood concentration levels of this agent with     nucleoside analog monotherapy, either zidovudine ( AZT ) or didanosine ( ddI ), based on the     reduction of HIV viral burden.      SECONDARY: To use pharmacokinetic parameters to assess the relationship between daily drug     exposure and antiviral activity and toxicity of the U-90152, AZT, and ddI monotherapy. To     assess anti-HIV activity using other disease markers.      Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent     and safe anti-HIV agents and may have different biological behavior than other currently     available non-nucleoside RT inhibitors.   "
161270|NCT00000811|"     This study compares 2 different treatments administered to try to prevent serious bacterial     infections (such as pneumonia) in HIV-positive children. A combination of drugs (azithromycin     plus atovaquone) will be compared to sulfamethoxazole-trimethoprim (SMX/TMP) alone. This     study also evaluates the long-term safety and tolerance of these different drugs.      SMX/TMP is a commonly prescribed drug for the prevention of bacterial infections. However,     the combination of azithromycin and atovaquone may be safer and more effective than SMX/TMP.     This study compares the 2 treatments.   "
161536|NCT00000523|"     To assess exercise training adherence and compliance over two years in subjects who were at     relatively high risk for coronary artery disease. Also, to test strategies for improving     adherence and compliance and to assess the effect of exercise training.   "
161537|NCT00000524|"     To determine whether immunosuppressive treatment improved cardiac function in patients with     biopsy-proven myocarditis.   "
161271|NCT00000812|"     PRIMARY: To evaluate the safety, tolerability, and pharmacokinetics of daily oral     thalidomide.      SECONDARY: To examine the effect of thalidomide on antiviral activity and tumor necrosis     factor-alpha (TNF-alpha) production, and the correlation between TNF-alpha inhibition and     viral burden.      A protein in the blood called tumor necrosis factor (TNF-alpha) is abnormally elevated in     patients with HIV infection and may cause the body to produce more virus. In vitro studies     have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV.     However, more information on the pharmacological and immunological aspects of thalidomide is     needed.   "
161272|NCT00000813|"     Part A: To evaluate the safety and immunogenicity of ALVAC vCP125 HIV-1 gp160 MN live     canarypox recombinant vaccine (ALVAC gp160 MN) versus a recombinant canarypox expressing the     rabies glycoprotein (ALVAC rabies glycoprotein) as a control in healthy, HIV-1 uninfected     adult volunteers.      Part B: To evaluate the schedule of two immunizations with ALVAC gp160 MN for optimal     immunogenicity.      Amendment: 12/22/93: To determine whether ALVAC gp160 MN in combination with SF-2 rgp120     subunit protein is capable of generating humoral and cellular immune responses of greater     intensity and longer duration than either vaccine administered alone.      A canarypox-vectored vaccine (ALVAC) that expresses the gp160 antigen of the HIV-1 MN strain     might satisfy many criteria for an affordable HIV vaccine. Per 12/22/93 amendment: Cellular     responses have been augmented by the combination of two recombinant vaccines, especially in     vaccinia naive individuals.   "
161273|NCT00000814|"     To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of     zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection.      The duration of clinical benefit from zidovudine (AZT) may be limited because of development     of viral resistance to the drug. Use of combination antiretroviral therapy can potentially     reduce viral load and prevent emergence of multidrug resistance.   "
161274|NCT00000815|"     To compare measles seroconversion rates (development of antibodies) at 13 months of age in     HIV-infected and uninfected children on one of two immunization schedules: attenuated     measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine     (Attenuvax) at 6 months plus M-M-R II vaccine at 12 months.      Recommendations for the age at vaccination should balance the need to minimize the risk of     morbidity and mortality with the benefit of achieving the highest seroconversion rates.     Immunizing a more intact immune system at an earlier stage of HIV infection may in turn     achieve better and long-lasting measles protection. This study will help define a more     effective measles vaccine regimen for children diagnosed with HIV infection and will provide     greater insight into the functional status of the HIV-infected children's humoral immune     system.   "
161275|NCT00000816|"     To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces     the incidence of treatment-limiting adverse reactions compared to the routine initiation of     the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients.      Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP     prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study     in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose     over 2 weeks, no significant adverse reactions have occurred.   "
161276|NCT00000817|"     To evaluate the separate and combined efficacy of a standardized acupuncture regimen and     amitriptyline on the relief of pain due to peripheral neuropathy and on the quality of life     of HIV-infected patients.      Both amitriptyline, an antidepressant, and acupuncture, a Chinese medical approach that uses     needles to relieve pain, have been used successfully to reduce pain in some people. It is not     known how effectively these approaches relieve or reduce pain in patients with peripheral     neuropathy secondary to HIV infection.   "
173409|NCT00103545|"     The purpose of this study is to use an immunologic approach following the treatment for     recurrent disease in patients with ovarian, fallopian tube, or peritoneal cancer.   "
161277|NCT00000818|"     PRIMARY: To determine the effect of 8 weeks of zidovudine (AZT) treatment on the HIV-1 burden     in peripheral blood and lymphoid tissue in HIV-1-infected, AZT-naive patients with CD4+ T     lymphocyte counts between 100 and 500 cells/mm3.      SECONDARY: To determine the extent to which apoptosis (programmed cell death) occurs in these     patients.      In previous trials of AZT treatment in HIV-infected patients, an antiviral effect has been     clearly demonstrated by quantitative measurement of virus in plasma and peripheral blood     mononuclear cells. However, the lymphoid tissues appear to be a major reservoir for HIV-1 and     a major site of virus replication in HIV-infected persons. Further data is needed to assess     the effect of treatment on viral burden and HIV-1 replication in lymphoid tissue.   "
161278|NCT00000819|"     To determine the efficacy and safety of prednisone in patients with HIV-associated     nephropathy. To determine the effects of prednisone on serum creatinine, urinary protein, and     creatinine clearance.      HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal     insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in     patients with advanced HIV disease. Little is known about the effects of corticosteroids on     the progression of HIV disease. In light of the possible beneficial effects of     corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is     warranted.   "
161279|NCT00000820|"     PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To     determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus     antiretroviral therapy alone.      SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and     antibody responses to protein and polysaccharide vaccines.      The profound immune impairment that results from HIV-1 infection is due, at least in part, to     the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and     interferon-gamma. Antiretroviral agents do not directly address the problem of immune     impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical     immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1     infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may     provide an adjuvant effect on vaccine responses.   "
161280|NCT00000821|"     To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin (     interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To     compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers.      Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study,     patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those     with more advanced infections, and those with higher baseline CD4+ counts tended to derive     the greatest benefit.   "
161281|NCT00000822|"     To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected     patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte     proliferation, specific antibody responses, and DTH reaction. To describe the durability of     the immunogen in patients who respond to the first 7 injections when they are boosted every 8     weeks for an additional 6-12 months [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. To     describe the ability of the immunogen to induce a response after an additional 6-12 months of     injections among patients who did not respond to the first 7 injections [AS PER AMENDMENT     11/12/96: stratum 1 patients only].      HIV-specific cellular immune responses appear to play an important role in HIV disease     progression since both T helper and cytotoxic function against HIV decrease with disease     progression.   "
161282|NCT00000823|"     To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine     ( ddI ) alone and in combination, as well as in various sequences of administration.      The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear;     thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit     pathogenicity.   "
161283|NCT00000824|"     To define the safety of cytotoxic T lymphocytes (CTLs) generated from sibling-supplied     dendritic cells and lymphocytes and infused into an HIV-infected patient. To determine the     efficacy of these CTLs in helping the immune system to fight HIV.      With lower CD4 counts, HIV-infected patients may not be able to produce dendritic cells and     lymphocytes, special types of immune cells that generate HIV-specific CTLs. Infusion of CTLs     generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the     body to recognize HIV more readily and increase immune response against the virus.   "
161284|NCT00000825|"     The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus     anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the     immune system that fight infection) of at least 350 cells/mm3. This study will also examine     the ability of antiretroviral therapy combined with IL-2 to boost the immune system.      IL-2, given through injection under the skin, in combination with anti-HIV therapy can     increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the     safest and most effective dose to use.   "
161285|NCT00000826|"     To determine the effects of fluconazole and either rifabutin or clarithromycin, alone and in     combination, on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone     in HIV-infected patients.      Although prophylaxis for more than one opportunistic infection is emerging as a common     clinical practice in patients with advanced HIV disease, little is known about possible     adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic     adverse interactions of the many combination prophylactic regimens that may be prescribed.   "
161286|NCT00000827|"     To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV     immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children.      Passive antibody therapy has been used with limited success in treating advanced HIV disease     in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic     donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced     HIV-positive children.   "
161287|NCT00000828|"     To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with     perinatal HIV transmission.      Most HIV-infected infants acquire their disease via perinatal transmission. Since     transmission of HIV-resistant strains to infants could alter the course of disease and     response to currently recommended treatment, a study to assess the patterns of AZT     susceptibility among mother/infant pairs with perinatal transmission is essential to     delineate future therapeutic strategies.   "
161288|NCT00000829|"     To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate     vaccine have more local reactions at the site of injection and systemic reactions than     placebo subjects. To assess whether this vaccine is more immunogenic than placebo following     the third vaccination.      Children with HIV infection are at increased risk for invasive pneumococcal infection,     particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited     number of serotypes. The maximum number of pneumococcal serotypes that can be included in a     new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent     pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular     saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin     mutant carrier protein.   "
161289|NCT00000830|"     To determine the levels of zidovudine triphosphate ( AZT-TP ) in maternal and fetal cord     blood mononuclear cells. To determine the ratio of AZT-TP to endogenous nucleoside     triphosphate levels in maternal and fetal cells. To determine the extent of drug transfer     through the feto/placental unit.   "
161290|NCT00000831|"     To elucidate the relationship between virologic risk factors and immunologic and clinical     progression in patients receiving monotherapy in protocol ACTG 175, and to compare new     treatment regimens with combinations of reverse transcriptase inhibitors in long-term     recipients of monotherapy. Specifically, to determine, in patients who have been taking     zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to     AZT or to switch to d4T alone, and also to determine, in patients who have been taking     didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to     ddI.      Characteristics of virus replication, pathogenicity, and resistance are thought to determine     the durability of virologic and clinical response to nucleoside reverse transcriptase     inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of     ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response     compared to continuation of AZT alone.   "
161291|NCT00000832|"     To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant     emulsion versus MF59 alone in HIV-negative volunteers.      One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine     the immunogen with an adjuvant.   "
161394|NCT00000936|"     Kidney transplantation is often successful. However, despite aggressive anti-rejection drug     therapy, some patients will reject their new kidney. This study is designed to test two     anti-rejection approaches. Two medications in this study are currently used in children, but     there is no information regarding which drug is safer or more effective.      Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for     an improved post-transplant treatment, such as the induction therapy used in this study.   "
161292|NCT00000833|"     To compare the safety, toxicity, and tolerance of two doses of ribavirin in combination with     didanosine (ddI) to HIV-infected children. To determine the toxicity of ddI/ribavirin and     compare it to the expected toxicity of ddI monotherapy. To determine the effect of concurrent     ribavirin on the pharmacokinetics of ddI. To determine a dosage of ribavirin that would be     suitable for a Phase II/III evaluation of ddI/ribavirin.      Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of     didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the     intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of     ddI.   "
161293|NCT00000834|"     To determine the safety and tolerance of methotrexate in HIV-infected patients. To determine     the dose effective in modulating key markers of immune activation. To determine a dose     suitable for Phase II or III evaluation in HIV-infected patients.      In HIV infection, complete immunological clearance of the foreign antigen does not occur,     resulting in chronic immune activation. Because chronic immune activation may contribute to     disease progression in HIV infection, immunomodulators may have therapeutic value in early     HIV disease prior to development of opportunistic infections. The clinical benefits of     methotrexate appear to derive from an anti-inflammatory effect; thus, it may reduce the state     of chronic immune activation.   "
161294|NCT00000835|"     The purpose of this trial is to determine the safety and immunogenicity of an HIV-1     pseudovirion vaccine given at one antigen dose alone and in combination with each of two     different adjuvants using two immunization schedules.      The pseudovirions are virus-like particles generated by in vitro production of HIV-1 viral     proteins which are capable of assembly into particles. The presence of gag gene products in     addition to envelope glycoprotein should assist in humoral and cellular immunologic responses     to internal HIV-1 viral proteins. The pseudovirion vaccine has been tested in preclinical     trials in mice, guinea pigs, rabbits, and nonhuman primates with good safety and     immunogenicity profile.   "
161295|NCT00000836|"     To compare the safety and efficacy of sevirumab (MSL 109; Protovir), human     anti-cytomegalovirus (CMV) monoclonal antibody, plus active primary treatment versus placebo     plus active primary treatment in AIDS patients with newly diagnosed and relapsed CMV     retinitis.      Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic     toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these     drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL     109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may     increase initial response and prolong time to progression in patients with CMV retinitis.   "
161296|NCT00000837|"     The purpose of this study is to see if it is safe to give Varivax to HIV-positive children     and whether it protects children from infection. Varivax is a vaccine against varicella     zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster).      VZV can cause many serious complications in HIV-infected children. Varivax is a VZV vaccine     that has been approved for use in healthy children. More research is needed to find out how     this vaccine will affect HIV-infected children.   "
161297|NCT00000838|"     To evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with     zidovudine (AZT), stavudine (d4T), or didanosine (ddI) in comparison with d4T or ddI     monotherapy in HIV-infected patients with no prior nucleoside therapy.      3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC     resistance mutations. One explanation is that the M184V mutation, which confers resistance to     3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy     with other nucleoside analogs.   "
161298|NCT00000839|"     To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI)     administration in third trimester pregnant women who are HIV positive but are either     intolerant or resistant to zidovudine (AZT). To collect data on infant toxicity following     maternal treatment with ddI during the third trimester of pregnancy.      AZT may not be the optimal antiretroviral agent for all pregnant women requiring therapy for     HIV infection. Although ddI has been approved for use in HIV-infected adults and older     children, the safety and pharmacokinetics of ddI in pregnant women has not yet been     determined.   "
161299|NCT00000840|"     To evaluate viral load in the blood stream of HIV-infected patients during a 28-day washout     following cessation of long-term zidovudine ( AZT ) therapy.      Because viral load (amount of HIV RNA in the plasma) is often used as a measure of the     effectiveness of new antiretroviral drugs in clinical trials, a washout period, or cessation     of current antiretroviral regimens, is commonly required for study entry to allow for a     drug-free steady state of viral load prior to initiation of the new drug. However, the     kinetics of the viral rebound following drug withdrawal has not been sufficiently studied,     and the proper duration of washout is an estimate.   "
161300|NCT00000841|"     To determine the clinical efficacy of indinavir sulfate or placebo in combination with     zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients.      Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV     disease who have received prior AZT therapy. Since studies suggest that triple drug therapy     may have an advantage over both monotherapy and two drug therapy, the combination of     indinavir sulfate with AZT and 3TC should be evaluated.   "
161301|NCT00000842|"     To assess the efficacy, safety, and tolerability of recombinant human nerve growth factor (     rhNGF ) in the treatment of HIV-associated sensory neuropathy. AS PER AMENDMENT 5/6/97: To     compare the change in viral load between the double-blind phase baseline and week 4 in     placebo and active rhNGF recipients. To ensure that rhNGF does not induce an increase in     viral load compared with viral load changes seen with placebo.      Up to now, treatments for HIV-associated sensory neuropathy have been symptomatic, relying on     pain-modifying agents or membrane-stabilizing drugs. Because nerve growth factor is important     in the development and maintenance of sympathetic and sensory neurons and their outgrowths,     it is proposed that recombinant human nerve growth factor may provide a specific restorative     treatment for HIV-associated painful sensory neuropathy.   "
161455|NCT00000441|"     This project will provide relevant clinical information for primary care practitioners     treating alcohol withdrawal syndrome in outpatient settings. This double-blind, placebo-     controlled clinical trial will compare the effectiveness of lorazepam (Ativan) and     carbamazepine (Tegretol) in alcoholics who meet the criteria for a diagnosis of uncomplicated     alcohol withdrawal syndrome. Participants are randomized to five days of treatment with a     1-week posttreatment followup.   "
161302|NCT00000843|"     To evaluate the single-dose pharmacokinetic profile and acute toxicity of bis-POM PMEA (     adefovir dipivoxil ) in HIV-1 infected children, and to determine whether age-related     differences exist. To ascertain dosages that may be suitable for a multiple-dose evaluation     in this patient population.      Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has     resulted in increased bioavailability in adult patients in clinical trials. However, the     safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and     the direction of the variation is not predictable. This study will assess these parameters of     bis-POM PMEA in children.   "
161303|NCT00000844|"     To evaluate the effects of three preparations of low-dose oral interferon alpha (i.e.,     Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate     differences in response to oral interferon alpha according to gender, race/ethnicity, and use     of antiretrovirals.      Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha     have produced different results, and it is not clear whether the differences were due to the     interferon alpha products used or to problems in the study design. Therefore, three     preparations will be compared to evaluate their potential efficacies.   "
161304|NCT00000845|"     To evaluate an HIV synthetic lipopeptide candidate vaccine component, P3C541b, at two dose     levels, administered subcutaneously (s.c.) in a randomized, double-blind, placebo controlled     study.   "
161305|NCT00000846|"     To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the     UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched     peptide when administered sequentially by 2 different routes of immunization, parental     priming followed by oral boosting.   "
161306|NCT00000847|"     To evaluate the safety and immunogenicity of high-titered ALVAC-HIV MN120TMG (vCP205) given     sequentially or simultaneously with rgp120/HIV-1SF2 in MF59 adjuvant emulsion in HIV-negative     volunteers.      ALVAC-HIV vCP205 is a second-generation candidate vaccine that can be used to induce a     humoral and cellular response against several antigens. vCP205 expresses proteins from two     strains of HIV (MN and LAI). rgp120/HIV-1SF2 expresses proteins from a different strain of     HIV. This study will help to show how the immune system responds to proteins from more than     one strain of virus.   "
161307|NCT00000848|"     To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule     formulation of saquinavir or to indinavir following prolonged use of the original hard     capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA.      Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have     shown that cross-resistance occurs among protease inhibitors, although no clinical trials     have been conducted to examine antiretroviral activity with sequential use of protease     inhibitors or to determine whether saquinavir resistance can be overcome with higher     concentrations of the drug.   "
161308|NCT00000849|"     The purpose of this study is to determine the safety and maximum tolerated dose (the highest     dose that can be given safely) of recombinant Interleukin-2 (rIL-2) in HIV-infected children.     This study also evaluates the effect of rIL-2 on the immune system of these patients.      IL-2 is a substance naturally produced by the body's white blood cells that plays an     important role in helping the body fight infection. HIV-infected patients do not produce     enough IL-2, and it is hoped that the use of rIL-2 may improve immune system function in     these patients. First, it is necessary to determine the safety and effectiveness of this drug     in HIV-infected children.   "
161309|NCT00000850|"     The purpose of this study is to see how HIV-positive patients who are taking anti-HIV drugs     and have a viral load (level of HIV in the blood) of 1,500 copies/ml or more respond to     GM-CSF (granulocyte-macrophage colony-stimulating factor).      GM-CSF is a medication that is being tested in HIV-positive patients to see if it can improve     their immune systems or if it can lower the level of HIV in their blood. GM-CSF is often     given to patients with leukemia or patients who have received bone marrow transplants to     increase their white blood cells and to improve their immune systems. Doctors believe that     GM-CSF can increase CD4 counts in HIV-positive patients, but this study will also look at how     GM-CSF affects viral load.   "
161310|NCT00000851|"     To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone     and in combination with didanosine (ddI), and whether concurrent administration alters the     disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long     term changes from baseline in plasma HIV RNA concentrations. To determine the relationship,     if any, between drug exposure and viral burden.      In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the     three children with baseline counts greater than 50 cells/micro liter experienced a 20%     increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the     same regimen for children with less advanced HIV disease should be undertaken.   "
161311|NCT00000852|"     To examine, in HIV-infected patients, the safety of allogeneic lymphocyte transfer (i.e.,     infusion of white blood cells taken from an HIV-negative parent, sibling, or adult offspring     who has a compatible blood type). To measure the distribution and survival of allogeneic     lymphocytes in the circulation of HIV-infected patients, and to determine whether their     infusion results in enhanced immunity. To determine whether enhanced immunity is passively     transferred or actively induced.      There is evidence that periodic infusion of allogeneic lymphocytes obtained from the     peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in     some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled     studies are needed to better quantitate the immunologic reconstitution seen with this type of     therapy.   "
161336|NCT00000877|"     The purpose of this study is to evaluate the safety of giving indinavir and rifabutin at the     same time (simultaneously) vs 4 hours apart (staggered) to HIV-positive and HIV-negative     adults.      It is important to determine which medications for HIV-associated diseases, such as     Mycobacterium avium complex (MAC) disease, can be given safely and effectively with anti-HIV     drugs. Indinavir and rifabutin have been given simultaneously in the past with good results.     This study seeks to examine if staggering the doses will make the 2 drugs more effective.     HIV-negative volunteers are used in this study to examine the effect of rifabutin on     indinavir and the effect of staggered rifabutin doses. The effect of rifabutin on the drug     activity of indinavir is evaluated in HIV-positive patients.   "
161312|NCT00000853|"     To expand the safety information regarding MN rsgp 120/HIV-1 formulated with QS21 or alum. To     evaluate the immunogenicity of low doses of MN rsgp 120/HIV-1 formulated with QS21 or alum.      Studies to date indicate that there may be a dose-sparing effect with the use of QS21. In     animal studies, when QS21 has been employed as an adjuvant, it shifted both the dose response     curve and allowed less antigen to elicit equivalent binding antibody titers to the rgp120     protein. There may also be an acceleration in the course of antibody response after both the     first and the second immunizations. Although the final titers in response to vaccine given in     both alum and QS21 appear similar after 3 doses in humans, this plateau may be reached more     readily, and with a lower antigen dose, when using QS21 as an adjuvant. In addition, it has     been established that using a lower dose of antigen may elicit an immune response which is     characterized by lymphoproliferation and production of TH1-like cytokines such as INF-gamma,     interleukin-2, interleukin-4, interleukin-5 and interleukin-10.   "
161313|NCT00000854|"     The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will     cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting).      Wasting has become an AIDS-defining condition. In the past, most studies that examined     wasting treatments were limited to men. However, it appears that wasting in HIV-positive men     is linked to levels of testosterone (a hormone which affects men's bodies more than women's).     This study has been designed for women only, in order to best treat wasting in HIV-positive     women.   "
161314|NCT00000855|"     The purpose of this study is to examine the safety and tolerability of ZDV when given to     premature infants born to HIV-positive women to prevent HIV infection.      ZDV has been used successfully to prevent the transmission of HIV from mother to child during     pregnancy and birth. However, ZDV has been given to very few premature babies, and the best     dose to use has not yet been determined.   "
161315|NCT00000856|"     To determine the safety and CSF penetration of combined ganciclovir and foscarnet treatment     for presumed cytomegalovirus encephalitis or radiculomyelopathy.      This study proposes to investigate the use of combined ganciclovir and foscarnet to maximize     the antiviral regimen. Current evidence suggests that a combination of ganciclovir and     foscarnet may be the most efficacious therapy and appears to be well tolerated. This study     will provide key information regarding safety and CSF penetration of the drugs available for     treatment of these lethal diseases. It will also provide preliminary information regarding     virologic factors relevant to CMV CNS disease. The study will also provide further data about     the natural history of CMV brain infection detected by a combination of symptom complex and     PCR identification of CMV in CSF and the potential of semi-quantitative PCR evaluation of the     CSF for the disease.   "
161316|NCT00000857|"     The purpose of this study is to determine the tolerance and effectiveness of rhIL-12 in     HIV-positive patients with CD4 cell counts less than 50 cells/mm3 versus 300-500 cells/mm3.     This study will look at the ability of rhIL-12 to boost the immune system against HIV and     HIV-associated bacterial infections in these patients.      IL-12 is found naturally in the body and rhIL-12 is the commercially produced version. IL-12     may enhance anti-HIV immune system activity by increasing the number of cells that fight     infection. IL-12 may also increase the body's ability to fight bacterial infections such as     Mycobacterium avium complex (MAC).   "
161524|NCT00000511|"     To test the efficacy of omega-3 fatty acids in untreated mild hypertensives and magnesium,     calcium, and potassium supplementation supplementation in non-hypertensives. These clinical     trials were conducted in sequence over a four year period.   "
161317|NCT00000858|"     To correlate HIV-1 viral load in vaginocervical secretions (VCS), as measured by culture and     nucleic acid detection, with that found in peripheral blood and HIV clinical status. To     determine whether systemic and local HIV specific antibody influences the quality and type of     virus isolated from VCS. To ascertain whether the presence of specific infectious agents     (e.g., HPV, HSV, CMV, etc.) influences the amount and type of virus isolated from VCS.      Predictors for the development of the acquired immunodeficiency syndrome (AIDS) in HIV     infected individuals have been studied primarily among adult males and in selected small     populations. Although many of these predictors may be relevant to women, HIV infection does     manifest itself differently between the sexes. Therefore, it is important to study the     spectrum of HIV disease in women and to identify unique and common markers, cofactors, and     predictors of disease progression.   "
161318|NCT00000859|"     To compare nelfinavir (NFV) with ritonavir (RTV) for delaying disease progression or death in     HIV-infected patients with CD4+ cell counts less than 100 cells/mm3 [AS PER AMENDMENT     3/11/98: less than or equal to 200 cells/mm3]. To compare NFV with RTV for the development of     adverse events and for rates of permanent discontinuation of study medication.      [AS PER AMENDMENT 10/02/97: To compare by intention-to-treat analysis for disease     progression, including death, the following two regimens: NFV plus background combination     antiretroviral (AR) therapy followed by indinavir (IDV) or RTV in the event of significant     intolerance; and RTV plus AR therapy followed by IDV, then NFV, in the event of significant     intolerance.] [AS PER AMENDMENT 3/11/98: SUBSTUDY CPCRA 045: To determine the relative rates     of emergence of HIV-1 resistance and to compare changes in plasma HIV RNA levels and CD4+     cell counts in a sample of patients with CD4+ cell counts <= 200/mm3 who are enrolled in     protocol CPCRA 042.] AR therapy is rapidly becoming the standard of care for the treatment of     HIV infection. AR therapy provides the best opportunity for maximizing viral suppression,     reducing toxicity and delaying the emergence of resistant strains. The newest class of AR     agents, the HIV protease inhibitors, exhibits the most potent anti-HIV effects described to     date. This study will compare 2 protease inhibitors, NFV and RTV for efficacy and safety in a     population with advanced HIV disease, who are taking various background nucleoside therapies.   "
161319|NCT00000860|"     To determine if treatment of MAC infection in HIV-1 infected persons is associated with the     decreases in plasma levels of TNF-alpha.      Infection with MAC is a poor prognostic indicator in persons with AIDS. Evidence suggests     that this poor outcome is not simply a reflection of greater immune impairment in AIDS     patients with MAC infection, but rather may be a direct or indirect consequence of infection     with mycobacterium. Survival of AIDS patients with MAC is shorter than those without MAC.     Studies show that treatment for MAC improves the survival of MAC infected patients to nearly     the survival of AIDS patients without MAC. Treatment of MAC with clarithromycin containing     regimens is associated with decreased symptoms and prolonged survival. There is evidence,     however, that mycobacterial infection may enhance propagation of the human immunodeficiency     virus through mechanisms that may involve enhanced expression of pro inflammatory cytokines.     It is unclear to what extent cytokine abnormalities contribute to this symptom complex and to     what extent treatment of MAC infection will reverse these cytokine abnormalities.   "
161320|NCT00000861|"     The purpose of this study is to evaluate the effect of immediate versus deferred indinavir     (IDV) in addition to background therapy on disease progression or death in patients with CD4+     cell counts between 200 and 500 cells/mm3 and plasma HIV RNA levels >= 10,000 copies/ml.      This study aims to examine two management strategies, immediate versus deferred IDV therapy,     for their clinical effects in the context of background antiretroviral (AR) therapy, given     according to current clinical practice. There is an urgent need to identify the optimal use     of IDV in patient management, since clinical endpoint studies have not been completed in the     United States. Since there is little information about the long term durability of clinical     effects, and even less information about the timing of the initiation of protease inhibitor     therapy, exploring the disease progression and survival impact of immediate versus delayed     use of IDV will yield important information to guide clinical decision making for this group     of patients.   "
161321|NCT00000862|"     To obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral     administration of Zidovudine (ZDV) during labor and delivery will provide a similar profile     to that obtained with the use of IV ZDV in ACTG 082. To evaluate the tolerance of oral ZDV in     this population, defined as the ability to take oral doses and lack of vomiting within 30     minutes of receiving oral study doses.      The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not     practical or feasible. Approximately 18% of the women in the ACTG 076 trial missed their IV     ZDV infusions, even at experienced ACTG sites. There is an urgent need to establish a more     practical method of delivering ZDV during labor and delivery that, at minimum, will     approximate the rate of ZDV administration utilized in ACTG 082. In the future, this would     enable women to start an intensive ZDV regimen during early labor, even prior to reaching the     hospital.   "
161322|NCT00000863|"     To evaluate the efficacy of WR 6026 once daily in the treatment of mild PCP. To evaluate the     safety and tolerance of WR 6026. To assess the correlation between plasma WR 6026     concentrations and outcome/toxicity.   "
161323|NCT00000864|"     The purpose of this study is to determine the safety, tolerance, and metabolism of     single-dose and multiple-dose abacavir (ABC) in HIV-exposed infants receiving standard     postnatal treatment with zidovudine (ZDV). This study also evaluates the correct dosages of     ABC to be used in future studies.      Early aggressive therapy may be the best chance to slow disease progression in infants who     may have been infected with HIV by their mothers. Early HIV suppression may significantly     reduce viral levels and allow for restoration of the immune system, providing improved     control over HIV infection. Therefore, it is important that the safety and tolerance of ABC     in combination with ZDV be examined as potential early therapy in newborn and young infants.   "
161324|NCT00000865|"     To assess the steady state pharmacokinetic features, tolerance, and safety of orally     administered 1592U89, given alone or in combination with other antiretroviral medications, in     HIV infected infants and children. To establish doses of 1592U89 appropriate for future     pediatric Phase II/III clinical trials.      On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent     for treatment of HIV infection in children, either as an alternative to currently employed     agents, or in combination therapy regimens. A liquid formulation of the drug is available;     thus concurrent development of 1592U89 for children and adults is possible.   "
161325|NCT00000866|"     To evaluate the safety of administering Therion Recombinant Vaccinia-HIV-1 IIIB env/gag/pol     Vaccine (TBC-3B) vaccinations to vaccinia-naive individuals. To evaluate the immunogenicity     of priming with TBC-3B by the scarification, intradermal, and subcutaneous routes, followed     by booster immunization of MN rgp120 HIV-1. To compare the immunogenicity of priming with     TBC-3B in vaccinia-naive individuals to vaccinia-immune individuals.      In prior trials evaluating alternative methods of vaccine administration, scarification has     been found to be an imprecise method of administration and allows only 1.0 - 2.5 microliters     of immunogen to be given. Since it is not feasible to produce vaccine at concentrations     higher than 10 to the 10th pfu/ml, this method limits the maximum deliverable dose.     Intradermal and subcutaneous injection routes allow larger volumes of vaccinia to be given,     i.e.: up to 200 microliters intradermally and up to 100 ml subcutaneously. In the present     study, the initial priming dose will be the same administered by all 3 methods; however, the     second priming dose administered at 2 months intradermally and subcutaneously will be 2 logs     higher in order to achieve boosting of immune responses, particularly to gag and pol     components of TBC-3B.   "
161326|NCT00000867|"     The purpose of this study is to determine the safety and effectiveness of memantine, an     experimental drug, in improving AIDS dementia complex (ADC).      The symptoms of ADC can be improved with zidovudine (ZDV). However, ZDV therapy has been     associated with significant toxicities, and the effectiveness of ZDV seems to decrease during     the second and third years of therapy. The effectiveness of other antiretroviral drugs as     treatment for ADC is not known, so it is important to explore alternative therapies.   "
161327|NCT00000868|"     The purpose of this study is to evaluate the safety and effectiveness of giving healthy     volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell. This     oral vaccine (HIV-1 LAI gp120) will be given with or without a different injected HIV vaccine     (HIV-1 MN rgp120).      Vaccines are preparations that are introduced into the body to try to prevent infection or     create resistance to infection. This study examines a new oral vaccine to see if it can     improve the immune system's ability to fight the HIV virus when given alone or with another     injected vaccine.   "
161328|NCT00000869|"     The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to     HIV-positive pregnant women and their babies can help reduce the chance that a mother will     give HIV to her baby during delivery. This study will also test the safety of the drug and     see how well it is tolerated by the mother and her baby.      Previous studies suggest that NVP is a promising medication for blocking HIV transmission     from HIV-positive mothers to their babies.   "
161337|NCT00000878|"     The purpose of this study is to evaluate the safety and tolerance of 2 anti-HIV drugs, d4T     and 3TC, given in combination to HIV-positive pregnant women and their infants.      Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine (ZDV) to treat HIV     and reduce the chances of giving HIV to their babies. It recently has been shown that a     combination of drugs may be more effective than ZDV alone. This study tests the effectiveness     of combinations of ZDV, d4T, and 3TC.   "
162166|NCT00002036|"     To investigate the potential benefit of providing passive immunity with hyperimmune anti-HIV     human serum.   "
161329|NCT00000870|"     To compare two different routes of intermittently administered rhIL-2 with a highly active     antiretroviral regimen (HAART) to HAART alone. The comparison is based on the following:     proportion of patients achieving at least 50-percent increase in CD4 counts above     prerandomization baseline values after 1 year of rhIL-2 and the rate of change in CD4 counts.     To compare the safety and tolerance of these regimens and their effect on quality of life. To     assess the effects of rhIL-2 when combined with HAART on changes in immune cell phenotypes     and function and on HIV viral load and the rate of antiviral drug resistance development.      The poor responsiveness of late stage HIV-infected patients to rhIL-2 is thought to occur     because of low T cell regenerative capacity and high viral burden. If means were available to     effectively suppress virus replication, the indigenous immune restorative responses of the     host may be further stimulated and enhanced by rhIL-2. The use of protease inhibitors with     nucleoside-analogue combination regimens appears to be most effective in controlling virus     replication. High-dose intermittent rhIL-2 administered either intravenously or     subcutaneously has been shown to be effective in inducing CD4 responses in a number of     studies.   "
161330|NCT00000871|"     To expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine     strategies: canarypox vector vCP205, or vCP205 with SF-2 rgp120. [AS PER AMENDMENT 7/2/98: To     obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing     antibody response to primary isolates of HIV-1 in the context of previous immunization with a     canarypox vector expressing HIV antigens (vCP205). To evaluate cytotoxic T lymphocyte     responses at 1 and 2 years after initial vaccination with vCP205 plus rgp120 SF-2 or vCP205     alone.] In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies     that neutralize homologous laboratory strains; over 50% of patients have developed CD8+     cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This     Phase II study seeks to confirm these results among persons at lower or higher risk for HIV     infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential     large-scale trials. [AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts     starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced     neutralizing antibody response as deemed from prior studies and thus is planned as     follow-up therapy.]   "
161331|NCT00000872|"     This trial tests the safety and effectiveness of the early use of combinations of anti-HIV     drugs in HIV-infected infants and young children in an effort to block virus growth and     preserve normal immune functions.      Various anti-HIV drug combinations need to be tested in order to find the best way to treat     infants and children who have been infected with HIV during birth.   "
161332|NCT00000873|"     This study examines the effects of an infant formula containing increased calories, as     compared to commercial formulas, when given during the first 6 months of life. It will     examine effects on growth, disease progress, immune system, and quality of life of infected     infants.      HIV disease in infants often leads to nutritional deficiencies. Providing increased nutrition     early in their lives may help the quality of life of children who contract HIV from their     mothers.   "
161525|NCT00000512|"     To compare the effects of two intensive lipid-lowering regimens with conventional therapy on     coronary atherosclerosis as assessed by arteriography.   "
161333|NCT00000874|"     To determine the short-term virologic and immunologic effects of using plasma genotypic     antiretroviral resistance testing (GART) results (interpreted by study virologists AS PER     AMENDMENT 9/17/97) in the management of therapy for antiretroviral-experienced patients     failing on one of the following regimens:        1. zidovudine (ZDV) + (lamivudine) 3TC + (indinavir) IDV        2. ZDV + 3TC + saquinavir (SQV)        3. ZDV + 3TC + ritonavir (RTV)        4. stavudine (d4T) + 3TC + IDV. [AS PER AMENDMENT 11/26/97: To determine the short-term          effects of using plasma GART in the management of antiretroviral-experienced patients          failing on a triple drug regimen that includes a single protease inhibitor (indinavir          [IDV], saquinavir [SQV], ritonavir [RTV], or nelfinavir [NFV]) and two licensed          nucleoside reverse transcriptase inhibitors (NRTIs).] A growing body of evidence          suggests that antiretroviral resistance is associated with an increased risk of disease          progression and death. All commercially available antiretrovirals and many of those in          development have been associated with resistance. Fortunately, techniques are available          to define HIV genotypic resistance in real time as compared to techniques that measure          phenotypic resistance that is not practical in a clinical setting. Using genotypic          antiretroviral resistance testing (GART) results, along with other currently available          markers, may lead to improved treatment decisions compared with using currently          available markers alone.   "
161334|NCT00000875|"     To evaluate the safety of anti-HIV CTL therapy in early stage patients and to verify the     safety when combined with antiviral therapy with zidovudine/lamivudine/indinavir and low-dose     interleukin-2 (IL-2). To compare the effects on plasma and cell-associated viral load     following combination drug therapy with and without antiviral CTL in early-stage patients. To     study in detail the immune effects of lowering viral burden with antiviral combination drugs     with and without T cell infusion on antiviral CTL activity, viral suppression and     proliferation, circulating T cell phenotype, T cell apoptosis, CD4 cell numbers, DTH     reaction, and inflammatory cytokine levels.      In an HIV-infected person, there is an ongoing struggle between HIV replication and host     immune control. In the past decade most therapeutic strategies have targeted the virus. This     approach has been frustrated by viral mutation to evade drug sensitivity. Promising drugs     have recently been approved and there are encouraging sustained results from combination     antiviral chemotherapy. However, even the most potent drug regimens do not seem to be     curative, may eventually lead to drug resistance and may not completely restore lost immune     function. The addition of immune-based therapy to antiviral drugs may lead to better viral     control.   "
161335|NCT00000876|"     CD4-IgG2 is a special man-made protein that was built to block the entrance of HIV into CD4     cells (cells of the immune system that fight infection). The purpose of this study is to see     if giving CD4-IgG2 to HIV-infected children is safe and effective.      HIV attaches to CD4 cells and enters them. Inside, HIV makes copies of itself that will help     the virus invade the body. CD4 cells are killed or disabled during this process of HIV     replication. Decreases in CD4 cells lead to a weakened immune system. When CD4 cell counts     become very low, the body is unable to defend itself, and HIV infection develops into AIDS.     The protein used in this study, CD4-IgG2, may be able to attach to HIV and inactivate it so     that it cannot enter CD4 cells. This is an early study to examine CD4-IgG2 as a possible     treatment for HIV in children.   "
161338|NCT00000879|"     The purpose of this study is to see if giving the ALVAC vCP1452 anti-HIV vaccine alone or     with another vaccine called AIDSVAX B/B to babies of HIV-positive mothers is safe. The study     will also look at how these vaccines affect a baby's immune system. Most HIV-positive     children get HIV from their mothers during pregnancy or birth. Treatment with anti-HIV drugs     can reduce the baby's risk of getting HIV. Vaccines also may help prevent HIV infection. This     study will look at whether the ALVAC vCP1452 vaccine and the AIDSVAX B/B vaccine can help the     body fight off HIV infection. There is no chance of getting HIV infection from the vaccines.     (This study has been changed. In earlier versions, ALVAC vCP205 and AIDSVAX B/E were going to     be used.)   "
161339|NCT00000880|"     The purpose of this study is to determine the safety and effectiveness of low doses of     cyclosporine (CsA) in patients with early HIV infection and to evaluate its effect on the     immune system.      Activation of T cells (cells of the immune system) leads to HIV replication. Inhibition of     immune activation is therefore a potentially important area of therapy for patients with     early HIV infection. CsA is capable of decreasing T cell activation, which in turn may     decrease HIV replication.   "
161340|NCT00000881|"     Part A: To determine the safety and pharmacokinetics of sequential single doses of cidofovir     in HIV-infected children with end-organ cytomegalovirus (CMV) disease. Part B: To determine     the safety (including time to progression of CMV retinitis by retinal exam),     pharmacokinetics, and long-term (6 months) tolerance of multiple-dose cidofovir in     HIV-infected children with CMV retinitis. Part B: To determine the effect of multiple-dose     cidofovir on the virologic parameters of CMV retinitis (viral load, shedding, and resistance     to antiviral agents).      [AS PER AMENDMENT 1/7/98: To determine the safety, tolerance and pharmacokinetics of     sequential single doses of cidofovir in HIV-infected children with CMV retinitis. To     determine the safety (including time to progression of CMV retinitis by retinal exam),     pharmacokinetics, and long-term (6-month) tolerance of multiple doses of cidofovir in     HIV-infected children with CMV retinitis.] While the intravenous formulation of cidofovir has     been approved for the treatment of CMV retinitis in HIV-infected individuals, information is     limited regarding its safety and tolerance in HIV-infected children. Intravenous cidofovir     requires less frequent administration for both induction and maintenance therapy of CMV     retinitis than other currently available therapies. If found to be safe and well tolerated in     HIV-infected children with CMV retinitis, intravenous cidofovir would add significantly to     agents available to treat this debilitating opportunistic infection.   "
161346|NCT00000887|"     The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus     lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will     also look at how long these drugs stay in the blood.      ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their     babies. However, better treatments are needed to further reduce these chances and to better     suit the treatment needs of mothers and their children. Taking a combination of anti-HIV     drugs during pregnancy may be an answer.   "
173800|NCT00108953|"     The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus     sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma     (HCC).   "
161341|NCT00000882|"     To compare the proportion of patients in the 2 zidovudine (ZDV)-containing arms who have a     plasma HIV RNA concentration below the limit of detection (defined as 500 copies/ml or less)     at Weeks 20 and 24 [AS PER AMENDMENT 8/24/98: HIV RNA concentration below the limit of     detection is now defined as 200 copies/ml or less]. To compare the safety and tolerability of     the different treatment regimens. To compare the decrease in plasma HIV-1 RNA and the change     in CD4 count from baseline to the average of Weeks 20 and 24 [AS PER AMENDMENT 12/19/97: and     to the average of Weeks 44 and 48; AS PER AMENDMENT 8/24/98: and the average of Weeks 88 and     96] in the 2 ZDV-containing arms. To study the emergence of resistance to ZDV, lamivudine     (3TC), stavudine (d4T), delavirdine (DLV), and indinavir (IDV) in treated patients. To     correlate the antiviral and immunologic activity and emergence of drug resistance with     pharmacologic parameters of study drugs. To delineate the pharmacokinetic interactions of IDV     and DLV. [AS PER AMENDMENT 12/19/97: To delineate the possible development of cellular     resistance to nucleoside analogs and the consequences of switching nucleoside study drugs on     intracellular phosphorylation.] To document rates and patterns of adherence over the course     of the study, from day of randomization through 48 weeks. [AS PER AMENDMENT 8/24/98: To     define long-term durability of the virologic activity of the different treatment regimens, as     defined by the proportion of patients with plasma HIV-1 RNA levels that remains below the     limit of detection. To define long-term tolerability of the different treatment regimens.]     Although a change in reverse transcriptase (RT) inhibitors is recommended when adding or     changing protease inhibitors in a treatment regimen, the choice of available RT inhibitors is     often limited by prior exposure, toxicity, or pharmacologic interaction with the protease     inhibitors. This study addresses the question of whether to continue 3TC or substitute the     nonnucleoside reverse transcriptase inhibitor (NNRTI) DLV when adding IDV to therapy for     patients previously treated with ddI or d4T plus 3TC who have greater than 500 copies/ml of     plasma HIV-1 RNA. Although the activity of DLV as monotherapy or in combination with     nucleoside reverse transcriptase inhibitors is of limited duration due to rapid emergence of     resistance, it is possible that DLV will contribute significantly to the activity of 3-drug     regimens that include a new RT inhibitor plus a protease inhibitor.   "
161342|NCT00000883|"     The purpose of this study is to see if there are any changes in sugar and fat levels in the     blood when patients take anti-HIV therapy for many years. Another goal is to test memory and     mental concentrations to determine if anti-HIV drugs protect the brain from damage caused by     HIV.      (The purpose of this study has been changed from the original version.) HIV-infected patients     with low CD4 cell counts are at risk for getting opportunistic (AIDS-related) infections. CD4     cells are cells of the immune system that help fight infection. Anti-HIV therapy may increase     CD4 counts, which may lead to a decrease in AIDS-related infections. Problems that anti-HIV     therapy is associated with include metabolic problems, neurologic problems, abnormal     opportunistic infections, and cancer. Patients in ACTG 362 have been exposed to anti-HIV     therapy longer than any other large group in the ACTG. These patients appear to benefit from     their therapy, but also suffer problems from it. Observation of these patients should provide     more information about long-term anti-HIV treatment and may detect unexpected problems.      (This study as been changed. More information about the reasons for conducting this study has     been added.)   "
161343|NCT00000884|"     To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein,     delivered by a variety of mucosal routes. To evaluate the antibody, humoral, and cellular     immune responses resulting from ALVAC-HIV vCP205. [AS PER AMENDMENT 8/3/98: To obtain safety     data on AIDSVAX B/B boosting administered by the intramuscular and intranasal routes in the     context of previous immunization via alternate mucosal routes or intramuscularly with a     canarypox vector expressing HIV-1 antigens (vCP205). To obtain immunogenicity data on AIDSVAX     B/B boosting.] One of the earliest observations in the HIV epidemic was the demonstration of     HIV infection at mucosal surfaces of cells in the genital tract. These data suggest that     priming of immune defenses of viral infected cells may be an important component in the     strategy of developing an effective HIV vaccine. Direct immunization of relevant mucosal     surfaces with a vectored vaccine may stimulate mucosal immunity. The ALVAC-HIV vCP205     immunogen is constructed from a live recombinant canarypox vector that has a good safety     profile in volunteers and should allow mucosal induction of immunity.   "
161371|NCT00000912|"     The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to     determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while     on the treatment. This study evaluates the safety of these drug combinations, which include     an experimental protease inhibitor (PI), amprenavir.      Despite the success that many patients have had with PI treatment regimens, there is still a     possibility that patients receiving PIs may continue to have high HIV blood levels. Because     of this possibility, alternative drug combinations containing PIs are being studied. It     appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in     patients with prior PI treatment experience.   "
161344|NCT00000885|"     Group A:      To compare the time to confirmed virologic failure (2 consecutive plasma HIV-RNA     concentrations of 500 copies/ml or more) between the treatment arms: abacavir (ABC) or     placebo in combination with zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV). To     evaluate the safety and tolerability of these treatment arms. [AS PER AMENDMENT 06/16/99: To     compare the time to confirmed treatment failure, permanent discontinuation of treatment, or     death between the treatment arms.] [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed     follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable.]      Group B:      To compare the proportion of patients who achieve plasma HIV-1 RNA concentrations below 500     copies/ml, as assessed by the standard Roche Amplicor assay at Week 16, or to compare the     absolute changes in plasma HIV-1 RNA concentrations at Week 16 across the treatment arms: ABC     or approved nucleoside analogs and nelfinavir (NFV) or placebo in combination with efavirenz     (EFV) and adefovir dipivoxil. To compare the safety and tolerability of these treatment arms.      Group C:      To monitor plasma HIV-1 RNA trajectory over time and determine the time to a confirmed plasma     HIV-1 RNA concentration above 2,000 copies/ml on 2 consecutive determinations for patients     treated with ZDV or stavudine (d4T) plus 3TC and IDV.      Group D:      To evaluate plasma HIV-1 RNA responses at Weeks 16 and 48. To evaluate the safety and     tolerability of the treatment arms: ABC, EFV, adefovir dipivoxil, and NFV.      This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited     number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and     are currently exhibiting a range of virologic responses. By dividing the study into the     corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating     virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e.,     plasma HIV-1 RNA levels of 500 copies/ml or more [AS PER AMENDMENT 12/27/01: 200 copies/ml or     more], are explored while maintaining long-term follow-up of ACTG 320 patients. [AS PER     AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only     information pertinent to Group A is applicable. This study will examine the question of     whether intensification of therapy can prolong the virologic benefit in individuals whose     plasma HIV-1 RNA concentrations have been below the limits of assay detection on ZDV (or d4T)     plus 3TC plus IDV.]   "
161345|NCT00000886|"     To evaluate the safety of HIV-1 gp120 C4-V3 hybrid polyvalent peptide immunogen (C4-V3     peptides) formulated in mineral oil containing mannose mono-oleate (IFA) in HIV-1 uninfected     volunteers. To evaluate the humoral and cellular immune responses to the C4-V3 peptides as     measured by the induction of 1 or more of the following: neutralizing antibodies to HIV-1 MN     and RF, cross-neutralizing antibodies to primary isolates of HIV-1, HIV-1 antigen-specific     lymphoproliferation, CD8+ and CD4+ cytotoxic T lymphocyte (CTL) activity specific for HIV-1     gp120 or V3 peptides corresponding to the vaccine strains of HIV-1, induction of HLA-B7 and     HLA-A2 restricted CD8+CTLs, and induction of HIV-specific DTH responses.      The test immunogen (C4-V3 peptides) is constructed from 4 sequences of the HIV-1 V3 gp120     loop shared by approximately 80% of North American HIV-1 strains. Because of the critical     role that this region plays in generating anti-HIV sequences, it is hypothesized that the     test immunogen (C4-V3 peptides) will be capable of inducing a broad range of cross-reactive     neutralizing antibodies in the majority of recipients.   "
162178|NCT00002048|"     To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) in     HIV-infected adult patients without clinical manifestations of disease. To assess the     efficacy of AZT therapy in the treatment of HIV disease in these patients.   "
161347|NCT00000888|"     The purpose of this study is to see if it is safe and effective to give ritonavir (RTV) plus     lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to     their babies after birth.      Pregnant women who are HIV-positive are at risk of giving HIV to their babies during     pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women     from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against     HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV     infection from mother to infant but studies are needed to determine whether they are safe and     effective during pregnancy.   "
161348|NCT00000889|"     To demonstrate the safety and tolerability of subcutaneously administered interleukin-2     (IL-2) plus antiretrovirals in patients with HIV infection and CD4 counts of 350 cells/mm3 or     more. To demonstrate the immunological efficacy of subcutaneous IL-2 therapy plus     antiretroviral therapy relative to antiretroviral therapy alone.      IL-2, given through injection under the skin, in combination with anti-HIV therapy can     increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the     safest and most effective dose to use.   "
161349|NCT00000890|"     The purpose of this study is to determine whether HIV-positive patients with extremely low     viral loads (level of HIV in the blood) have a greater gain in lean tissue during anti-HIV     (antiretroviral) therapy than patients with higher viral loads.      Many HIV-positive patients experience changes in body composition (muscle, fat, etc.) while     on antiretroviral therapy. However, any weight gained while taking antiretrovirals is mostly     fat. A patient's viral load may affect whether weight gained is a result of increased fat or     increased muscle. A large-scale study is needed to closely evaluate the effects of     antiretroviral therapy on body composition.   "
161350|NCT00000891|"     To evaluate the relationship between viral suppression and changes in immune function, as     measured by the restoration of delayed-type hypersensitivity (DTH) and lymphoproliferative     (LP) responses, observed after 48 weeks of treatment with highly active antiretroviral     therapy (HAART) in ACTG 315. To evaluate the durability of the antiviral and immunologic     effects of long-term treatment with HAART.      Given the extensive immunologic and virologic data available from ACTG 315, follow-up studies     of this advanced-disease population are indicated to primarily ascertain the impact of     long-term suppression of viral replication on immunologic reconstitution or re-education and     the durability of the antiviral effects of HAART.   "
161351|NCT00000892|"     To compare the proportion of patients whose plasma HIV-1 RNA is below 500 copies/ml after 16     weeks of treatment. To assess the safety, toxicity, and tolerance of each treatment arm.      While indinavir is currently the most commonly prescribed protease inhibitor, the optimal     therapy for a person on an indinavir-containing regimen who experiences a rebound in viral     load or never experiences a decrease in viral load below 500 copies per milliliter is     unknown. Current clinical practice for such patients typically involves empiric use of a     combination of other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir) and     at least 1 other antiretroviral agent to which the patient has had little or no prior     exposure. This may involve the use of 1 or more reverse transcriptase inhibitors (RTIs) or     nonnucleoside reverse transcriptase inhibitors (NNRTIs). This study attempts to formally     evaluate some of these options in indinavir-experienced patients.   "
161372|NCT00000913|"     The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule     formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with     other anti-HIV drugs.      SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is     still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule     form may be safer and more effective than other protease inhibitors.   "
161352|NCT00000893|"     Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV     medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find     an appropriate dose of EFZ to use in combination with NFV. Cohort II: The purpose of this     study is to see how safe it is to give EFZ syrup combined with NFV and to measure the levels     of EFZ and NFV in the blood. (This purpose reflects a change from the original since there     are now 2 different cohorts of patients.) EFZ is an effective anti-HIV medication that easily     can be combined with other drugs to treat HIV. This is an early study to determine a safe and     effective dose for HIV-positive children. This study also will examine the correct dose of     NFV to use in combination with EFZ.   "
161353|NCT00000894|"     To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth     (oral) and through an eye device (intraocular) , in order to determine the safety and     effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by     CMV (cytomegalovirus) retinitis.      Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV     retinitis.   "
161354|NCT00000895|"     The purpose of this study is to determine if infection with Mycobacterium avium complex (MAC)     occurs in other parts of the body before it is found in the blood. This study also evaluates     the relationships between the amount of HIV in the blood, immune system functions, and the     presence of MAC infection.      HIV-positive patients are at risk for MAC infection because their immune systems have been     weakened by HIV. It is hoped that aggressive treatment with anti-HIV drugs may improve their     immune systems enough to prevent against MAC.   "
161355|NCT00000896|"     The purpose of this study is to examine how the level of HIV is reduced in the blood when     anti-HIV therapy is initiated. This study will also evaluate whether adding GM-CSF or IL-12     to the anti-HIV drug regimen will increase the rate that HIV is reduced.      The anti-HIV drugs used in this study will include lamivudine (3TC), zidovudine (ZDV),     indinavir (IDV), nevirapine (NVP), and stavudine (d4T). All have been used successfully to     treat HIV. GM-CSF has been used to treat certain blood disorders; it will be used as an     experimental drug in this study. IL-12 (interleukin-12) is a protein found naturally in the     body that is thought to boost the immune system. Although GM-CSF and IL-12 have no direct     effect against HIV, these drugs may improve the ability of the immune system to fight the     virus.   "
161408|NCT00000950|"     The purpose of this study is to determine if a relationship exists between the level of     antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and     the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these     drugs are absorbed and metabolized in the body.   "
161356|NCT00000897|"     The purpose of this study is to look at the effects of different methods of birth control     (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV).     This study will also evaluate the differences in men and women in how the body absorbs, makes     available, and removes ZDV.      Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased     in individuals who use certain methods of birth control. ZDV may also have different effects     in men compared to women.   "
161357|NCT00000898|"     The purpose of this study is to see if staggering doses of nelfinavir, ritonavir, and     saquinavir has any effect on the interactions between these drugs.   "
161358|NCT00000899|"     The purpose of this study is to determine the safety of anti-HIV drugs combined with low-dose     chemotherapy (consisting of cyclophosphamide [CTX]) in HIV-positive patients. This study     examines whether this combination therapy can reduce the number of HIV-infected cells hidden     in the lymph nodes and blood.      Current anti-HIV drug treatments can greatly reduce the levels of HIV in the human body.     However, HIV can hide in certain immune cells and escape the drugs' effects. Chemotherapy     using CTX destroys these immune cells. When used with standard anti-HIV drug treatments, CTX     may be able to speed up the elimination of HIV-infected cells.   "
161359|NCT00000900|"     To describe the magnitude and duration of changes in HIV-1 RNA levels during and after an     acute febrile illness. To identify factors associated with increases, i.e., type of illness     ultimately diagnosed (bacterial, viral, fungal), CD4 cell count, and antiretroviral treatment     regimen. To describe changes in phenotypic markers of immune activation/dysregulation of CD4     and CD8 lymphocyte subsets and their relationship to intercurrent illness. To describe     changes in plasma cytokines and soluble activation markers and their relationship to plasma     HIV-1 viremia during and after the onset of intercurrent illness. To characterize the viral     biologic phenotype and the viral drug susceptibility genotype before, during, and after the     onset of an acute febrile illness. To characterize the expression of HIV-1 co-receptors     before, during, and after the onset of an acute febrile illness Repeated episodes of     intercurrent infections have been postulated to be an important stimulus for progression of     HIV infection. The study of intercurrent illness in patients with initially undetectable     viral load removes viral load as a possible cause for virologic and immunologic changes and     allows for a more direct association of the intercurrent illness with changes in viral load,     viral HIV-1 phenotypes, viral HIV-1 genotypes, and T cell phenotypes. Studying intercurrent     illness and viral load provides an opportunity to characterize the potentially dynamic     changes not only in viral load but also in phenotypic markers of T cell activation, plasma     cytokine levels, phenotypic and genotypic changes in circulating virus, and HIV-1 tropisms.   "
161360|NCT00000901|"     The purpose of this study is to see if it is safe and effective to give an anti-HIV drug     combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected     children. IDV will be given either as a powder mixed into applesauce or as capsules given on     an empty stomach.   "
161361|NCT00000902|"     The purpose of this study is to determine the value of changing anti-HIV medications in     children with progressive HIV disease who have received previous treatment.      Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by     giving patients anti-HIV drugs which affect the virus at various stages of development.     Changing the medications may enhance the results of treatment.   "
161373|NCT00000914|"     The purpose of this study is to compare different treatments for HIV infection to see which     works best to lower HIV levels and to raise the number of CD4 cells (cells of the immune     system that fight infection), in HIV-positive individuals who have been on a protease     inhibitor-containing drug regimen for at least 16 weeks.      Researchers have found that combination anti-HIV therapy (multiple drugs given together) can     help prevent AIDS-related illnesses and help people with AIDS live longer. In this study, the     anti-HIV drug efavirenz (EFV) will be tested with 1 or 2 other protease inhibitors (PIs) to     see which combination works best to treat HIV infection. EFV has been shown to limit the     amount of HIV virus produced by infected cells.   "
161362|NCT00000903|"     To compare time to a virologic failure (first of 2 consecutive plasma HIV RNA levels greater     than or equal to 200 copies/ml at or after Week 24) of each 4-drug regimen vs the 3-drug     regimen. To determine the safety, tolerance, and virologic benefits of either nelfinavir     (NFV) or efavirenz (EFV) with indinavir/lamivudine/zidovudine (IDV/3TC/ZDV) vs IDV/3TC/ZDV     alone, in the treatment of patients with advanced HIV disease who have received limited or no     prior antiretroviral therapy.      Prior ACTG studies have shown that the 3-drug combination regimen (IDV/ZDV/3TC) resulted in     improved clinical outcomes and therefore may prolong the effects of therapy. The enhanced     effects seen with combination therapies are likely related to a greater suppression of RNA     replication and alterations in resistance patterns. Due to the progressive success of     combination regimens, it is possible that more potent regimens will further enhance viral     suppression and provide more durable treatment responses. In light of the additive     suppression of HIV replication determined by pharmacological, immunological, and virological     results, nelfinavir (NFV) as an addition to IDV/ZDV/3TC will be evaluated. Based on the     potency of nonnucleoside reverse transcriptase inhibitors (NNRTIs) to suppress viral     replication and the effectiveness of 3-drug regimens containing NNRTIs, efavirenz (EFV) will     also be evaluated as an addition to IDV/ZDV/3TC.   "
161363|NCT00000904|"     The purpose of this study is to find out whether three different anti-HIV vaccines are safe     and whether they help prevent HIV infection. These vaccines are called vCP205, vCP1433, and     vCP1452. Some patients also receive another anti-HIV vaccine, gp160. The vaccines are made up     of small pieces of HIV, which help the body learn to recognize and destroy HIV. You cannot     get HIV from these vaccines.      There are two different ways a vaccine can protect the body from infection. First, a vaccine     may help the immune system make antibodies, which are proteins that recognize invading     viruses or bacteria. Second, a vaccine may help the body make immune cells that destroy     infected cells. The second type of vaccine is more powerful against HIV. In this study,     doctors will see whether vCP205, vCP1433, vCP1452, and gp160 are good vaccines by seeing     whether they help the body make immune cells.   "
161523|NCT00000510|"     To determine the effectiveness of dipyridamole and aspirin in prevention of restenosis of the     dilated lesion in patients who had undergone percutaneous transluminal coronary angioplasty     (PTCA). Secondary aims were to determine the effectiveness of platelet inhibitor therapy in     reducing the incidence of coronary events and the severity and incidence of angina.   "
161364|NCT00000905|"     The purpose of this study is to see if it is safe to stop maintenance therapy in HIV-positive     patients with treated and healed CMV retinitis (eye disease) who have responded well to     anti-HIV (antiretroviral) therapy.      The current therapies available to treat CMV retinitis are long-term therapies. However, it     may be safe to stop long-term anti-CMV therapy in patients with healed CMV retinitis and     stable CD4 counts resulting from taking a combination of at least 2 antiretroviral drugs.   "
161365|NCT00000906|"     The purpose of this study is to see if it is safe to combine methadone with two HIV protease     inhibitors (PIs), ritonavir (RTV) and saquinavir (SQV), in HIV-infected patients not     currently taking PIs. This study will measure the interactions between methadone and the PIs.      Methadone is used treat addicts and to treat severe pain. In order to find the safest way to     use methadone with PIs, it is important to evaluate how they interact.   "
161366|NCT00000907|"     The purpose of this study is to evaluate the effects of stopping preventive therapy for DMAC     in HIV-positive patients who (1) have been treated for DMAC for at least 12 months and are     now free of any signs of DMAC for at least 16 weeks, and (2) have improved immune systems     (CD4 cell counts greater than or equal to 100 cells/mm3) due to anti-HIV drug therapy.      DMAC is a serious and sometimes life-threatening infection that usually affects only     HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection)     less than 50 cells/mm3. It is recommended that people who are likely to get DMAC be placed on     preventive medications which help reduce the risk of infection. New anti-HIV combination drug     therapies can increase CD4 cell counts and can reduce the level of HIV in the blood. When CD4     counts are increased, risk of DMAC infection is less. This study examines whether it is     possible to stop preventive therapy for DMAC when CD4 counts are high without placing     individuals at risk for getting DMAC again.   "
161367|NCT00000908|"     The purpose of this study is to see how often Pneumocystis carinii pneumonia (PCP) occurs in     HIV-positive patients who have stopped taking medications that help prevent PCP.      The risk of developing PCP may be decreased when an HIV-positive patient's CD4 cell counts     (cells of the immune system which fight infection) are more than 200 cells/mm3. This study     looks at whether it is acceptable to stop PCP prevention treatment in these patients.   "
161368|NCT00000909|"     The purpose of this study is to evaluate the safety and tolerability of giving interleukin-2     (IL-2) alone to HIV-positive patients with CD4 cell counts greater than 350 cells/mm3 who do     not wish to receive anti-HIV (antiretroviral) therapy. This study will also determine if IL-2     given alone can increase CD4 cell counts or decrease the level of HIV in the blood.      IL-2 (a protein found in the blood that helps boost the immune system) can result in     increases in CD4 cell count (immune system cells that fight infection). IL-2 is normally     given in combination with antiretroviral therapy to treat HIV infection; however, some HIV     patients do not wish to take antiretrovirals. This study asks if it is safe and effective to     take IL-2 alone to treat HIV infection.   "
161369|NCT00000910|"     The purpose of this study is to collect medical information about HIV-positive pregnant women     and their babies who have been (or are being) seen at study sites. This information will be     used to help design future research studies for these patients.      The population of HIV-positive pregnant women and their babies who are seen at study sites     has not been officially examined. In order to design future studies to research the best care     for these patients, this study will examine important characteristics and the general number     of women in these trials.   "
161370|NCT00000911|"     The purpose of this study is to monitor patients who recently have been infected with HIV in     order to learn how their immune systems respond to HIV infection and to study how the virus     acts in their bodies.      Primary HIV infection occurs within 20 days to 8 weeks following exposure to HIV. The     symptoms of primary HIV infection are usually fever, tiredness, headache, or muscle aches.     However, symptoms vary greatly from person to person, and some people might not experience     any symptoms at all. Because these symptoms also resemble the cold or the flu, it is     difficult to identify patients with primary HIV infection. Information gathered from this     study will help doctors decide what kind of treatment is best to give patients who recently     have been infected.   "
161538|NCT00000525|"     To determine whether hypertensive patients with ECG abnormalities and receiving     hydrochlorothiazide diuretics were at increased risk of sudden death.   "
161374|NCT00000915|"     The purpose of this study is to estimate the rate at which a certain population becomes     infected with HIV. The individuals examined in this study are people who are expected to take     part in future studies of HIV vaccines and nonvaccine HIV prevention studies. This study also     examines the chances of becoming HIV-positive based on certain risk factors under conditions     that are similar to the conditions that would exist in HIV vaccine and non-HIV prevention     studies.      Before studying the effectiveness of a potential HIV vaccine, it is important to learn about     the range of HIV risk behaviors in the potential participants of these studies. The     probability of HIV infection associated with these risk behaviors should also be examined.     This study is designed to increase the ability of HIVNET to put into place HIV prevention     trials, to increase the diversity of trial participants, and to target populations at highest     risk for HIV infection.   "
161375|NCT00000916|"     This study compares the safety and effectiveness of continuing your current anti-HIV     medications to that of adding or switching some of your anti-HIV medications. It will follow     the effect of these medication changes, including the addition of hydroxyurea (HU), on     long-term viral suppression. Other medications which may be added include didanosine (ddI)     and/or stavudine (d4T).      Patients receiving combination antiretroviral therapy with indinavir (IDV), zidovudine     (ZDV)(or d4T) and lamivudine (3TC) show viral suppression for two years or more.     Discontinuation of one or two of these drugs results in prompt loss of the viral suppression.     Other studies show that addition of HU to some reverse transcriptase inhibitor treatments     results in increased antiviral effects. This study will provide further information on the     effect of adding HU to a treatment regimen with respect to long-term viral suppression.   "
161410|NCT00000952|"     The study examines the safety and effectiveness of ritonavir (an anti-HIV drug), alone and in     combination with other anti-HIV drugs, in HIV-positive children under 2 years of age. This     study will also determine the most effective doses of ritonavir for future pediatric HIV     studies.      Infants infected with HIV by their mothers experience faster disease progression than adults     or older children. Treatment with anti-HIV drugs administered at an early age may slow     disease progression in infant populations.   "
161376|NCT00000917|"     The purpose of this study is to set up a blood bank for infants who have HIV-positive     mothers. This blood may be used in the future to treat the child if he/she turns out to be     HIV-positive.      Blood from the umbilical cord contains a certain kind of cell called a stem cell. Stem cells     eventually turn into one of the many types of blood cells. If HIV infection can be prevented     in these stem cells, then, when these stem cells are injected back into the infant, the new     cells that develop will also be protected from HIV. This study will provide the blood needed     to test whether this type of gene therapy is safe and effective.   "
161377|NCT00000918|"     The purpose of this study is to determine the safety and effectiveness of combining several     anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in     HIV-positive patients who have failed nelfinavir (NFV) treatment.      In order to determine the ability of a drug regimen to decrease viral load after drug     treatment has failed, it is best to test a variety different of drug cocktails (drug     regimens). The drug cocktails in this study include 2 new nucleoside reverse transcriptase     inhibitors (NRTIs), efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor), and     either 1 or 2 protease inhibitors. It is important to include multiple drugs from different     groups in a drug cocktail since combinations containing fewer drugs are likely to fail.   "
161378|NCT00000919|"     The purpose of this study is to compare the effectiveness of various combinations of anti-HIV     drugs in HIV-positive men and women. Patients receive specific combinations of 3 or 4 of the     following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV),     lamivudine (3TC), or zidovudine (ZDV).      Anti-HIV therapy is effective in preventing the spread of HIV in the body. However, patients     often experience unpleasant side effects and have difficulties following the dosing schedule.     This study looks for combinations of anti-HIV drugs (cocktails) which will be the most     effective with the fewest problems.   "
161379|NCT00000920|"     The purpose of this study is to see if it is safe to give saquinavir-SGC (SQV) combined with     low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive pregnant     women and to see if it is safe to give 3TC and ZDV to their newborns. Another purpose is to     see what levels of SQV, low-dose RTV, ZDV, and 3TC are found in mothers and what levels of     ZDV and 3TC are seen in newborns. Another purpose of this study is to see whether SQV passes     from mother to newborn and if it passes at a level that is safe for the newborn.      Although ZDV has been able to reduce the rate of transmission of HIV from mother to child, it     may be possible to reduce it further by using a combination of anti-HIV drugs. This study     adds SQV (a protease inhibitor [PI]) with RTV (another PI) and 3TC (a reverse transcriptase     inhibitor) to the mother's ZDV regimen.   "
161380|NCT00000921|"     The purpose of this study is to see if it is safe and effective to give prednisone to     HIV-infected patients.      Prednisone is a corticosteroid, a hormone produced by the body that inhibits immune cell     responses. Prednisone may be able to lower the level of HIV in the body (viral load) by     reducing the number of cells that HIV can infect. At the same time, prednisone may be able to     increase CD4 cell counts (cells of the immune system that fight infection).   "
161381|NCT00000922|"     The purpose of this study is to determine whether it is better to start an anti-HIV regimen     containing a protease inhibitor (PI), a non-nucleoside reverse transcriptase inhibitor     (NNRTI), or a PI in combination with an NNRTI. This study will also examine which treatment     regimen is best as a first treatment for HIV infection.   "
161382|NCT00000923|"     This study examines the long-term effects of interleukin-2 (IL-2) in combination with     anti-HIV drugs, or highly active antiretroviral therapy (HAART). The purpose of this study is     to see if IL-2 can increase the number of CD4 cells (cells of the immune system which fight     infection) in HIV-infected patients who have completed ACTG 328.      HAART is often successful in decreasing viral load (level of HIV in the blood), but these     drugs have not been able to restore the immune systems of HIV-infected patients. IL-2 is a     substance naturally produced by the body's immune cells. In ACTG 328, IL-2 is tested to see     if it can increase the number of CD4 cells and boost a patient's immune system. This study     is a follow-up to ACTG 328 so that patients who are benefiting from IL-2 can continue to take     it and patients in the control group who do not receive IL-2 can start taking it.   "
161383|NCT00000924|"     This study compares 2 different anti-HIV drug regimens to determine which is the most     effective in lowering the amount of HIV in the blood. The anti-HIV drugs used in this study     are 2 protease inhibitors (nelfinavir and ritonavir), 2 nucleoside reverse transcriptase     inhibitors (stavudine and didanosine), and 1 nonnucleoside reverse transcriptase inhibitor     (nevirapine).      These drug combinations have been previously studied in adults, but there is limited     information on how well they work in HIV-infected children. It is important to develop drug     combinations which are effective at suppressing the HIV virus in children.   "
161384|NCT00000925|"     The purpose of this study is to determine whether a high-quality protein food supplement will     help HIV-positive patients maintain, and possibly gain, muscle mass.      Many HIV-positive patients lose weight that they are then unable to regain. This may be     because patients are not eating enough protein or are not eating the right kinds of protein.     The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the     amount of protein lost due to HIV infection. This study gives patients high-quality protein     food supplements to help them maintain and/or gain weight.   "
161385|NCT00000926|"     The purpose of this study is to see if nonoxynol-9 (N-9) gel used in the vagina can prevent     the spread of HIV.      Most of the people with HIV in the world today live in southern Africa. Because this     population is not likely to use condoms, an HIV-prevention method that women can control is     needed. N-9 used in the vagina may help prevent the spread of HIV and other sexually     transmitted diseases.   "
161386|NCT00000927|"     The purpose of this study is to see if it is safe to use BufferGel in the vaginas of women     who do not have HIV and who have a low risk of getting HIV.      Many new cases of HIV are the result of heterosexual activity. Condom use is currently the     only effective way of preventing the spread of HIV and other sexually transmitted diseases     (STDs). However, women, who have a greater risk of getting HIV, are often unable to convince     their partner to use a condom. Therefore, it is important to develop methods that prevent the     spread of HIV and that are controlled by the woman, such as medicines used in the vagina.     BufferGel is known to kill the organisms that cause STDs, including HIV. BufferGel may do     this without causing genital irritation and sores as other medicines do. More studies are     needed to see if this is true.   "
161387|NCT00000928|"     To assess the acceptability of and participation in a group counseling intervention,     including an assessment of willingness to disclose serostatus to a regular sexual partner and     the willingness of that partner to participate. To evaluate the profile of adverse     experiences (social, psychological, and physical harms) of individuals resulting from     participation in counseling and testing and attempts to initiate condom use within a stable     HIV serodiscordant partnership. To assess the potential for the intervention to result in     increased condom use among stable sexual partners.      There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant     couples. While condom use has been a major component of most AIDS prevention programs since     the mid-1980s, there has been little emphasis on promoting condom use within stable     partnerships. The most effective way to promote condom use among discordant couples remains     largely unknown.   "
161388|NCT00000929|"     The purpose of this study is to see if it is safe and acceptable for homosexual male couples,     where both partners have the same HIV status, to use Advantage 24 during anal intercourse.     Advantage 24 is a spermicide (a chemical that kills sperm).      Much research and development is being done with chemicals that can be controlled by the     receptive partner to prevent the spread of HIV and other sexually transmitted diseases     (STDs). Advantage 24 currently is used in the vagina as a form of birth control. The safety     of Advantage 24 is particularly important for HIV-positive men because they have a greater     chance of serious reaction to Advantage 24 due to other HIV-related conditions.   "
161389|NCT00000930|"     The purpose of this study is to see how HIV reacts in the immune systems of patients who have     recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs     in newly infected patients.      Certain populations are good candidates for participation in HIV vaccine trials. These groups     include men who have sex with men, IV drug users, and women at risk of getting HIV through     heterosexual contact. Learning how HIV behaves in these populations once they become infected     can help with the planning of future HIV vaccine studies.   "
161390|NCT00000931|"     The purpose of this study is to see if a behavioral intervention, a special kind of     counseling, can reduce the risk of HIV infection in men who have sex with men. The behavioral     intervention will be compared to the standard risk reduction counseling that is given before     and after getting an HIV test.      In standard pre- and post-test counseling, everyone is told the same things about how to     prevent HIV. The behavioral intervention used in this study is designed to help each     individual prevent HIV according to his specific problems and needs.   "
161391|NCT00000932|"     The purpose of this study is to collect information about life spans and HIV-related     illnesses in multiple groups of HIV-positive patients with varying anti-HIV treatment     experience, including no treatment at all.      Anti-HIV treatment has been successful in slowing disease progression in many patients.     However, there are still questions regarding the best way to use anti-HIV drugs. This study     is designed to provide long-term monitoring of patients who have already received anti-HIV     treatment as well as patients who are just beginning treatment or have decided not to receive     treatment.   "
161392|NCT00000933|"     Some people who have taken azithromycin to prevent MAC (Mycobacterium avium Complex, a     bacterial infection common in HIV-infected persons) have been found to carry     antibiotic-resistant bacteria (germs that grow despite the presence of drugs used to kill     them). The purpose of this study is to see if people who take azithromycin carry more     antibiotic-resistant bacteria than people who have chosen to delay MAC preventive therapy.      When bacteria like Streptococcus (a type of bacteria that causes pneumonia and meningitis)     are frequently exposed to antibiotics, the bacteria can become resistant to the drugs. MAC     preventive therapy uses antibiotics, but this can make it difficult to treat other infections     caused by bacteria that have become resistant in HIV-infected persons. If MAC preventive     therapy is delayed, Streptococcus in the body may be less likely to develop resistance.     Therefore, if the patient does get a Streptococcus infection, it will be easier to treat     because it is not resistant to the antibiotics.   "
161393|NCT00000935|"     This study is designed to test the clinical and laboratory observations that suggest IVIG     given before and after kidney transplant to patients who are sensitized (highly sensitive) to     certain transplant antigens could result in reduced sensitization and reduced rates of kidney     rejection.      Some ESRD patients are highly sensitive to certain transplant antigens (foreign substances     that activate the immune system) and must wait for a long time before a well-matched kidney     becomes available. Transplant rejection is more likely among highly sensitized patients than     in patients who are not highly sensitized. There is no proven method to improve a     highly-sensitized patient's chances of receiving and keeping a transplanted kidney.   "
161395|NCT00000937|"     The purpose of this study is to see how well antibiotics work in reducing chronic fatigue     symptoms, such as tiredness, in patients that were treated for Lyme Disease. Fatigue is a     common symptom of Lyme Disease. When fatigue does not improve after treatment, patients are     considered to have Post Lyme Syndrome (PLS). The chronic fatigue seen in these patients     appears to be related to the initial infection which causes Lyme Disease. It is believed, but     not proven, that treatment with antibiotics may be effective in relieving chronic fatigue in     PLS patients.   "
161396|NCT00000938|"     Lyme disease is the most common tick-borne disease in the United States. It is caused by the     spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1)     persistent infection by B. burgdorferi; 2) damage caused by the original infectious process;     or 3) the presence of coinfection with another organism transmitted by Ixodes ticks. The     purpose of this study is to determine the safety and effectiveness, in seronegative patients,     of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).   "
161409|NCT00000951|"     The purpose of this study is to determine whether it is better to treat patients with     fluconazole on a continuous basis to prevent thrush (yeast infection in the mouth) from     coming back or to wait and treat each episode of thrush.      Fluconazole is one of the most commonly prescribed drugs to treat thrush and other yeast     infections. However, the number of patients with fluconazole-resistant thrush is increasing,     and it is not known whether continuous or intermittent use of fluconazole leads to greater     resistance. Therefore, it is important to determine the most effective treatment strategy.   "
162187|NCT00002057|"     To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the     prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III     or IV, CDC classification).   "
161397|NCT00000939|"     This study will look at different anti-HIV drug regimens to see which works best to keep the     level of HIV (viral load) in the blood as low as possible during maintenance therapy. You     will be assigned randomly (like tossing a coin) to 1 of 3 groups:      Group 1: Didanosine plus stavudine plus hydroxyurea (ddI/d4T/HU). Group 2: Didanosine plus     stavudine plus efavirenz (ddI/d4T/EFV). Group 3: This group of patients will remain on their     current drug regimens. This study will last approximately 3 years; you will receive study     medications for the duration of the study.      Anti-HIV drug regimens that include protease inhibitors (PIs) are very good at lowering viral     load. However, some patients have a rise in HIV levels while on PI maintenance. It may be     possible to keep HIV levels low using another class of drugs for maintenance that are easier     to take and less expensive than PIs. If viral load increases while a patient is taking this     second group of drugs, it may be possible to restart the PI drug regimen and again decrease     HIV levels.   "
161398|NCT00000940|"     This study will determine what effect taking a combination of five anti-HIV drugs during the     early stage of HIV infection, then temporarily stopping them once or twice, may have on the     amount of HIV virus in the blood (viral load). The study will also evaluate the safety and     effectiveness of this anti-HIV drug combination.   "
161399|NCT00000941|"     The purpose of this study is to find out whether taking protease inhibitors (anti-HIV drugs)     together with lipid-lowering drugs (drugs which lower the amount of fat in the blood) has an     effect on the level of drugs found in the blood compared to when these drugs are taken     separately. The three protease inhibitors given in this study are ritonavir, saquinavir, and     nelfinavir. The lipid-lowering drugs given are pravastatin, simvastatin, and atorvastatin.      Anti-HIV drug therapy using protease inhibitors has become very common treatment for     HIV-positive patients. Recently, however, serious side effects involving how the body uses     fat have been reported in people taking protease inhibitors. Examples of these side effects     are redistribution of body fat and development of diabetes. People taking protease inhibitors     have been found to have higher levels of fat in their blood than is normal, which can cause     heart problems. It is hoped that giving lipid-lowering drugs can help prevent serious heart     problems. First, however, it is important to see what happens when protease inhibitors and     lipid-lowering drugs are given together.   "
161400|NCT00000942|"     The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to     HIV-positive pregnant women and their babies can help reduce the chance that a mother will     give HIV to her baby during delivery.      Previous studies suggest that NVP is a promising medication for blocking HIV transmission     from HIV-positive mothers to their babies.   "
161401|NCT00000943|"     The purpose of this study is to determine the effects of an HIV vaccine (Remune) on the     immune system. This study involves patients who have received at least 60 weeks of anti-HIV     therapy, either alone or in combination with IL-2, while enrolled in ACTG 328.      Remune is an experimental HIV vaccine. To see how the body's immune system reacts, this     vaccine will be given with 1 to 3 other vaccines, and skin tests will monitor the body's     reaction.   "
161402|NCT00000944|"     The purpose of this study is to determine if a combination anti-HIV drug treatment regimen of     indinavir plus lamivudine (3TC) plus zidovudine (ZDV) is effective in treating HIV and in     reducing the chances of passing HIV from mother to child. This study will also examine if     this combination is well tolerated by HIV-positive pregnant women and if a combination of 3TC     plus ZDV is safe for newborns.      Previous studies in adults and children have shown that indinavir plus 3TC plus ZDV can     reduce the amount of HIV in the blood. Most HIV-positive pregnant women usually take ZDV to     treat HIV and to reduce the chances of giving HIV to their babies. The combination of drugs     in this study may be more effective than ZDV alone.   "
161403|NCT00000945|"     The purpose of this study is to evaluate the safety, tolerance, and overall effectiveness of     cidovir to treat PML in AIDS patients.      PML is an opportunistic infection (HIV-associated, due to weak immune system) caused by a     virus that attacks the brain. Cidovir has been used effectively to treat cytomegalovirus     (CMV) of the eye. Cidovir could be an effective treatment for PML as well.   "
161404|NCT00000946|"     The purpose of this study is to test three experimental HIV vaccines. This study will look at     whether it is safe to give these vaccines together and how the immune system responds to the     vaccines.      There are a number of studies being performed to test HIV vaccines. The vaccines that seem to     be the most promising are canarypox vaccines, known as ALVAC vaccines. The three experimental     HIV vaccines used in this study are called ALVAC-HIV vCP205, HIV-1 SF-2 p24, and HIV-1 SF-2     rgp120. The HIV-1 SF-2 p24 and HIV-1 SF-2 rgp120 vaccines are mixed with an adjuvant, which     is a substance that increases immune response.   "
161405|NCT00000947|"     This study is designed to find out whether HIV-positive patients whose immune systems have     improved after receiving anti-HIV treatment should take azithromycin to prevent Mycobacterium     avium complex (MAC) disease. This study also examines the possibility of putting off MAC     prevention treatment in patients who respond well to anti-HIV drug therapy.      Azithromycin is approved for the prevention of MAC disease in people with HIV and low CD4     cell counts. However, some people who have taken azithromycin have been found to carry     antibiotic-resistant bacteria (germs that can grow despite the presence of drugs used to kill     them). It is not known whether the risks associated with taking azithromycin outweigh the     risk of getting MAC disease.   "
161406|NCT00000948|"     The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus     anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the     immune system that fight infection) of at least 350 cells/mm3. This study will also examine     the ability of antiretroviral therapy combined with IL-2 to boost the immune system.      IL-2, given through injection under the skin, in combination with anti-HIV therapy can     increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the     safest and most effective dose to use.   "
161407|NCT00000949|"     The purpose of this study is to examine how rIL-2 affects HIV-positive patients with CD4     counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to     increase CD4 cell counts, which help the body fight off HIV.      There is strong evidence that rIL-2 increases CD4 cell counts (cells of the immune system     that fight infection). This study examines the effect of 2 different amounts of rIL-2 on CD4     cell count and the amount of HIV in the blood (viral burden).   "
161411|NCT00000953|"     To compare the efficacy of oral sorivudine (brovavir) and oral acyclovir for the treatment of     localized herpes zoster in HIV-infected patients.      HIV-infected patients are at high risk for herpesvirus infections, including varicella-zoster     virus ( VZV ) infections, also called shingles. Acyclovir, an approved drug, is widely used     to treat VZV infections in the HIV population. Since no data from controlled studies are     available to define the role of antiviral therapy for VZV infections in HIV-infected     patients, a study is needed to test the relative efficacy of brovavir, an experimental     antiviral drug, versus that of acyclovir.   "
161412|NCT00000954|"     To determine the toxicity and response to treatment with cytotoxic chemotherapy using     doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's     sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC).      AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic     agents to reduce the tumor burden, and they also require treatment with other possibly     effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of     opportunistic infections.   "
161413|NCT00000955|"     To quantitate in an HIV-infected population the percentage of patients demonstrating the     booster phenomenon (attainment of a positive response to a second tuberculin purified     protein derivative skin test when the first skin test was negative); to determine the     relationship between the booster phenomenon and CD4-positive lymphocyte cell counts; to     detect any relationship between the booster phenomenon and HIV exposure category.      The accuracy of skin testing to detect Mycobacterium tuberculosis (MTb) infection is     dependent upon the host's ability to mount a delayed-type hypersensitivity (DTH) reaction;     however, the DTH response may be impaired or absent in patients with impaired cell-mediated     immunity, a classic characteristic of HIV infection. Patients in whom immunity is diminished,     but not absent, may test negative the first time a purified protein derivative skin test for     MTb is administered, but if the same skin test is repeated, a positive DTH response may then     be elicited. This occurrence is known as the booster phenomenon.   "
161414|NCT00000400|"     This study looks at the effects of two medications, alendronate and parathyroid hormone, on     bone mass and on bone formation and bone breakdown in women with osteoporosis. We will     randomly select postmenopausal women who have osteoporosis to receive laboratory-produced     human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants     will return to the study center periodically to have their bone mass measured and to give     blood and urine samples for tests of bone formation and breakdown and for other laboratory     tests. Those who complete the study are eligible for one or two 12 month extension studies.   "
161415|NCT00000401|"     Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation     of the joints. In RA, the immune system attacks a person's own cells inside joints,     eventually leading to joint damage and disability. This study will determine if oral bovine     type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.   "
161416|NCT00000402|"     We originally suggested that calcium in the diet is important in determining the amount of     bone (bone mass) that builds up in young adults. We are testing the effect of calcium on bone     mass in 354 Caucasian (white) girls. At the start of this 7-year study, the average age of     the girls was 11 years, and they had not yet reached puberty. The study will also provide     information about the effect of calcium on body composition (body fat) and blood pressure in     young women.      We have been giving calcium to one group of participants in this study and giving a placebo     (an inactive pill, or sugar pill) to the other group. The results of this research will be     important in preventing osteoporosis, because building more bone as a young person should     reduce a woman's chances of developing osteoporosis later in life.   "
161456|NCT00000442|"     This study is to evaluate the safety and effectiveness of an injectable slow releasing     preparation of naltrexone to reduce alcohol consumption and risk of relapse in     alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection     for a total of three months, with two subsequent followup visits spanning a 6- month period.   "
161417|NCT00000403|"     This study will determine whether doxycycline decreases the severity or rate of progression     of osteoarthritis (OA) in the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the     most popular agents used to treat OA, but elderly women, in whom OA is especially common, are     at greatest risk of developing serious side effects from NSAIDs.      Our study targets overweight middle-aged women who have OA in one knee. Half of the 432 study     participants will receive the treatment (doxycycline) and half will receive a placebo     (inactive pill). Treatment with doxycycline (or placebo) will last 30 months, and     participants and researchers will not know who is receiving doxycycline and who is receiving     placebo until the end of the study. We will look for narrowing of the joint space in the knee     that was not affected by OA at the start of the study. Joint space narrowing is a sign of OA.     We will also use questionnaires to evaluate participants' symptoms and functioning.   "
161418|NCT00000404|"     We will study 300 people with knee osteoarthritis (OA) who receive their medical care from a     large health maintenance organization (HMO) in Indianapolis. Our study will evaluate a     comprehensive plan for treatment of knee OA by primary care physicians. Primary care     physicians will provide standard care for knee OA to half of the study participants (150     people), and will use the comprehensive treatment plan guidelines to treat the other half.     The comprehensive plan includes careful use of medications along with non-drug approaches     such as patient education, exercise, and social support. People who participate in the study     will receive care for knee OA for 1 year. We will measure the results (outcomes) of treatment     at the start of the study and at 3 months, 6 months, and 12 months after patients join the     study. The results we will measure include joint pain, physical function, drug side effects,     quality of life, satisfaction with OA care, and the cost of medical care.   "
161427|NCT00000413|"     This study will test an osteoporosis prevention program aimed at preadolescent girls between     the ages of 10 and 12 who have not yet started their menstrual periods. Girls in this age     group are adding large amounts of new bone to their skeletons. Adding more bone at this time     of life can reduce a person's chances of developing osteoporosis (thinning bones) in later     years.      We will look at how this osteoporosis prevention program affects the amount of calcium in the     girls' diets, the amount of weight-bearing exercise they do, and their bone mass measured     using ultrasound testing of the heel.   "
161419|NCT00000405|"     In this study we will investigate the effects of a high-impact exercise program involving     jumping on bone mass (the amount of bone) of the hip and backbone in the growing skeleton. We     will also look at the effects of gradually stopping the jumping program on bone mass in the     growing skeleton. A high-impact exercise program may build more bone during childhood, while     the skeleton is still growing. This may help prevent broken bones due to loss of bone mass     later in life.      We will recruit 200 children aged 5-10 to participate in the study. For 6 months we will     train the children in either a jumping or stretching program. We will then gradually reduce     the amount of exercise over 6 months. We will measure bone mass in the hip and backbone at     the start of the study, after jumping, and 6 months after the jumping program is stopped. We     will compare the results in the jumping and stretching groups.   "
161420|NCT00000406|"     To understand the effects of leg strengthening exercise, we will study the effects of     strength training of the legs in four groups of people: (1) osteoarthritis (OA) with knee     pain; (2) OA without knee pain; (3) no OA but elderly with knee pain; and (4) normal elderly     with no OA or knee pain. In each of the first three groups, we will look at whether people     who do strength training have less pain and/or slower progression of x-ray signs of OA over     30 months than people who perform nonstrengthening, range-of-motion exercises. We are     including the fourth group to find out whether people with OA (groups 1 & 2) have the same     response to strength training as healthy elderly people, and whether those with knee pain     (groups 1 & 3) have the same response to training as those without joint pain.   "
161421|NCT00000407|"     The long-term objectives of this research project are to enhance program participation and     improve the employment prospects of people with work disability due to arthritis and related     musculoskeletal disorders (ARMD) who are actively seeking vocational (job-related)     rehabilitation (VR) services.      This study is designed to compare the employment situations of a group of people receiving a     two-part intervention and a group that is not receiving the intervention. The intervention     consists of training sessions to help prospective VR clients with ARMD successfully enter and     complete the VR program, and training sessions for a randomly selected group of VR     professionals to help them serve VR clients with ARMD more effectively.   "
161422|NCT00000408|"     Back pain is one of the most common of all symptoms. It is also a great cause of days lost     from work and visits to health care providers. This study will develop and evaluate an     approach to low back pain that allows subjects to talk with each other and with health     professionals via an Internet discussion group. Results we will look at include health     behaviors, such as exercise; health status, such as pain and disability; and health care use,     such as number of visits to doctors and other health care providers. Anyone 18 years old or     older who lives in the United States and has ongoing Internet access can take part in the     study. All subjects must have back pain and meet the eligibility criteria listed below.   "
161423|NCT00000409|"     This study tests the effectiveness of different treatments for the three most commonly     diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of     two commonly prescribed treatments (surgery and nonsurgical therapy) works better for     specific types of low back pain.      In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces     in the backbone that results in pressure on the spinal cord and/or nerve roots) caused by     degenerative spondylolisthesis (a condition in which one vertebra, or spinal bone, slips     forward on another) with either surgery or nonsurgical methods. This study does not cover the     cost of treatment.   "
161424|NCT00000410|"     This study tests the effectiveness of different treatments for the three most commonly     diagnosed lumbar (lower) spine conditions. The purpose of the study is to learn which of two     commonly prescribed treatments (surgery and non-surgical therapy) works better for specific     types of low back pain.      In this part of the study, people with lumbar intervertebral disc herniation (damage to the     tissue between the bones of the lower spine, or backbone) will receive either discectomy     (surgical removal of herniated disc material) or non-surgical treatment. This study does not     cover the cost of treatment.   "
161457|NCT00000443|"     The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the     treatment of alcohol dependent patients; b) investigate whether early versus late onset     alcoholism predicts treatment outcome; and c) determine whether the early and late onset     groups respond differently to treatment. Individuals will be typed into early onset and     late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient     treatment program.   "
161539|NCT00000526|"     To determine whether drug treatment of asymptomatic ventricular arrhythmias in     post-myocardial infarction patients reduced the incidence of sudden cardiac death and total     mortality.   "
161425|NCT00000411|"     This study tests the effectiveness of different treatments for the three most commonly     diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of     two commonly prescribed treatments (surgery and nonsurgical therapy) works better for     specific types of low back pain. Low back pain is one of the most widely experienced health     problems in the United States and the world. It is the second most frequent condition, after     the common cold, for which people see a doctor or lose days from work.      In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces     in the backbone that results in pressure on the spinal cord and/or nerve roots) with a type     of surgery known as posterior decompressive laminectomy or with nonsurgical methods. This     study does not cover the cost of treatment.   "
161426|NCT00000412|"     During the first year after a heart transplant, people often rapidly lose bone from their     spine and hips. About 35 percent of people who receive heart transplants will suffer broken     bones during the first year after transplantation. This study will compare the safety and     effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol)     in preventing bone loss at the spine and hip after a heart transplant.      In this study, people who have had a successful heart transplant will receive either active     alendronate and a dummy pill instead of calcitriol, or active calcitriol and a dummy pill     instead of alendronate for the first year after their transplant, starting within 1 month     after transplant surgery. We will measure bone density in the hip and spine at the start of     the study and after 6 and 12 months, and will also check for broken bones in the spine. This     research should lead to ways of preventing this crippling form of osteoporosis.   "
161428|NCT00000414|"     This project will evaluate the effectiveness and general usefulness of two arthritis patient     education programs. The first, the Arthritis Self-Management Program, is a 6-week,     community-based program taught in small groups by peer leaders. The second, the Self-Managed     Arthritis Relief Therapy (SMART) Program, is a computer-driven program delivered through the     mail. Participants in this project are people with rheumatoid arthritis or osteoarthritis who     are taking part in the larger long-term studies being conducted by ARAMIS (the Arthritis,     Rheumatism and Aging Medical Information System).   "
161429|NCT00000415|"     Doctors recommend that young children participate in daily physical activity to promote bone     health. However, studies in adults show that physical activity and increased calcium intake     cause noticeable benefits for bone health only when both factors occur together. The goal of     this study is to find out whether calcium intake changes the response of bone to activity in     children 3 to 4 years old. Children will participate in one of two programs conducted in     childcare centers 5 days a week for 1 year. One program will involve activities that use     large muscles (gross motor activity). The other will involve activities using small muscles     (fine motor activity). We will give a calcium supplement (1 gram per day) to half of the     children in each program and give the other half an inactive pill. We will measure bone mass     and bone mineral density at the beginning and end of the study. We will take measurements 12     months after the program's completion to see if physical activity and/or calcium supplements     have long-term effects on bone mineral density and physical activity.   "
161430|NCT00000416|"     People with rheumatic disorders (arthritis) often have trouble keeping their jobs. This study     will look at whether vocational rehabilitation (VR) will improve the ability of employed     people with arthritis to keep their jobs. Job retention VR services target key factors that     increase the risk of job loss. They aim to modify jobs to reduce barriers caused by     functional limitations and disease symptoms, future career planning, and establish a     partnership with a VR counselor for ongoing help.      We will conduct the study among patients with rheumatic disorders recruited in eastern     Massachusetts. We will give 120 study participants job retention services provided by VR     counselors. We will give another 120 participants literature about employment- related     resources. We will compare the outcomes of the two groups to evaluate the usefulness of job     retention services in preventing job loss in people with rheumatic disorders.   "
161431|NCT00000417|"     We will study the relationships among patient/partner communication, social support, and     self-efficacy (a person's belief in the ability to manage his or her disease) as they affect     the health of people with systemic lupus erythematosus (SLE, or lupus) over time. We are     assigning 150 people with lupus and their partners to either (1) receive counseling to     improve self-efficacy, partner support, and patient/partner problem solving or (2) see an     informational film about lupus. We will follow study participants for 12 months to find out     about their physical and mental health, disease activity, beliefs that they can take steps     that help them feel better, coping, social support, and couples communication.   "
161432|NCT00000418|"     Acute low back pain (severe pain that comes on suddenly and lasts a relatively short time) is     very common in the United States, and accounts for substantial illness, functional     limitations, pain, and health care costs. This study looks at whether a program designed to     improve self-efficacy (a person's belief in his or her ability to reach a goal, such as     managing one's own disease) and social support improves the health status of people with     acute low back pain.   "
161433|NCT00000419|"     Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test     whether postmenopausal women with systemic lupus erythematosus (SLE, or lupus) can safely use     the hormone estrogen. In this part of the study, we will look at the effects of estrogen     replacement therapy on the activity and severity of disease in women with SLE.   "
161434|NCT00000420|"     Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test     whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. We     will determine this by looking at the effects of oral contraceptives (birth control pills,     also known as the pill) on disease activity and severity in women with SLE. The results of     the study will show whether it is safe for women with SLE to use the pill.   "
161435|NCT00000421|"     The first part of this study will use the database of a large, ongoing NIH-sponsored lupus     study, Safety of Estrogen in Lupus Erythematosus National Assessment. We will examine the     levels of a blood protein known as C3a in a series of patient blood samples to see if C3a     levels predict lupus flares or are better than other blood tests, and therefore should be     used more widely in managing lupus. In the second part of the study we will add or increase     prednisone treatment on the basis of abnormalities in blood tests for C3a and dsDNA     antibodies. Early treatment based on increases in C3a and dsDNA antibodies, before the     patient develops physical signs of disease, may reduce lupus flares and, ultimately, the     patient's total steroid exposure.      We will follow study participants for 1 year on a monthly basis and do full physical     examinations and laboratory evaluations. If C3a and dsDNA antibody levels are increased     significantly above baseline levels while a patient is clinically stable, we will give the     patient either prednisone or an inactive pill (placebo) for 1 month. We will follow these     patients monthly to compare how often lupus flares occur in the two groups. This approach     could provide a novel method of preventing lupus flares, using C3a as a sensitive predictor     of flare.   "
161436|NCT00000422|"     This study will evaluate the effects of matching treatments to people with fibromyalgia     syndrome (FMS) on the basis of their psychosocial and behavioral characteristics. We will     look at how patients respond to a rehabilitation program that includes physical therapy and     information about fibromyalgia. We will combine this program with psychological treatments     that are either matched or mismatched to the way patients cope with and adapt to symptoms of     FMS. The second aim of our study is to better understand how different FMS symptoms may vary     together and how these symptoms change as a result of treatment in a person's natural     environment. People with FMS and healthy people of the same ages will record their moods,     thoughts, symptoms, activities, and fatigue levels three times a day for 2 weeks.     Participants will use palm-top computers to record these real-time assessments. This     approach will permit people to rate how they feel at a particular time rather than looking     back in time.   "
162204|NCT00002074|"     To compare the safety and effectiveness of fluconazole and amphotericin B as maintenance     treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.   "
161437|NCT00000423|"     This study tests the effects of social support and education on the health and well-being of     people with fibromyalgia (FMS). We recruited 600 adults with a confirmed diagnosis of FMS     from a large health maintenance organization. We randomly assigned the study participants to     one of three groups. People in the social support group met with others who suffer from FMS     for 2 hours every week for 10 weeks, and then monthly for an additional 10 months. The social     support and education group also had 10 2-hour weekly meetings followed by 10 monthly     meetings with others who suffer from FMS. Members of this group learned about the disease and     ways they can manage it themselves. The third group participated only in the five assessment     periods. The study lasted 4 years.   "
161438|NCT00000424|"     This study compared the effects of tidal lavage (washing out) of the knee joint and an     imitation lavage procedure in people with knee osteoarthritis. In tidal lavage, the doctor     flushes out a knee joint with repeated injections of a mild salt solution, done under local     anesthesia. Study participants had to meet standard criteria for diagnosis of osteoarthritis     but could have low, medium, or high severity of x-ray changes indicating knee osteoarthritis.     We performed the lavage procedure once, and did quarterly followups for 1 year. We permitted     patients to use some other osteoarthritis treatments during the study, such as non-narcotic     pain relievers, nonsteroidal anti-inflammatory drugs, and physical therapy.   "
161439|NCT00000425|"     This study will determine if there is a difference between commonly used nonsteroidal     anti-inflammatory drugs (NSAIDs) and acetaminophen (a pain-reliever that does not prevent     inflammation) for treating knee pain in osteoarthritis (OA). The two main results we will     look at are disease progression according to x-rays and disability over 3.5 years. Study     participants with moderate knee OA and knee pain will continue taking their NSAID or stop     taking their NSAID and start taking acetaminophen. Every 6 months we will send the     participants questionnaires that ask about pain, medication use, and disability. We will take     x-rays of the knees at the start of the study and again at the end of the study.   "
161440|NCT00000426|"     This study looks at the effects of calcium supplementation on bone density in women in their     third decade of life. We placed women aged 19-27 who take in low amounts of calcium in their     diets in one of two groups. We will give women in one group a placebo (inactive pill) and     women in the other group 1500 milligrams of calcium per day (as calcium carbonate). We will     monitor the results by looking at the change in bone mineral density measured at the hip,     total body, forearm, and spine. Treatment will last 3 years.   "
161441|NCT00000427|"     Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH)     stimulates the formation of new bone. The purpose of this study is to compare the     bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men     with osteoporosis over a two-and-a-half year period.   "
161442|NCT00000428|"     This study will compare the effectiveness of combination therapy with the drugs amitriptyline     and fluoxetine (AM+FL) and amitriptyline (AM) alone in the treatment of people with     fibromyalgia. Doctors will treat each study participant with both AM + FL and AM alone for 6     weeks at a time. The study uses a method that combines results from treatment of individual     patients to assess overall treatment effectiveness and help individual patients and their     physicians with their treatment decisions. This study will also help compare the results of     community-based studies (studies involving private doctors) and studies based at clinical     research centers.   "
161443|NCT00000429|"     This study looks at the effects of taking calcium pills on bone health in young people with     juvenile rheumatoid arthritis (JRA). In this 2-year study, children aged 6-18 who have JRA     will take either a calcium supplement or a matching placebo (inactive or dummy pill)     containing no calcium. During the study, researchers and patients will not know if a patient     is taking calcium or placebo. We believe that patients who take calcium supplements will have     at least a 10 percent greater increase in total body bone mineral density compared to     patients who take the placebo.      We will evaluate patients at Children's Hospital Medical Center every 6 months for 2 years.     During this 2-year period, participants in the study will take one multivitamin containing     400 IU (international units) of vitamin D and either 1,000 mg of calcium carbonate (Tums     tablets) by mouth or a matching placebo once a day. We will check patients 6 and 18 months     after the 2-year treatment period to find out if people in the Tums-treated group maintain     any increases in bone formation that occurred during the 2-year treatment period.   "
161444|NCT00000430|"     Osteoporosis, a condition in which bones are fragile and break easily, is a major health     problem for postmenopausal women. Research studies have shown that both estrogen/progestin     replacement therapy (hormone replacement therapy, or HRT) and alendronate are effective in     preventing and treating osteoporosis. However, because these drugs work in somewhat different     ways, a combination of the two drugs might protect women from osteoporosis better than either     drug alone. In this study we will test whether HRT and alendronate given together for 3.5     years to postmenopausal women with low bone mass will have a greater effect on bone than     either HRT or alendronate given alone. We will also give every participant in this study     calcium and vitamin D supplements.   "
161445|NCT00000431|"     Most chronic (long-lasting) wounds of the leg (also known as venous ulcers) fail to heal in a     reasonable period of time. Although researchers have made great progress in understanding how     the body repairs wounds, attempts to develop new treatments have been disappointing. In     general, treatments based on recent findings about the details of wound repair have not     greatly reduced the number of people who have chronic wounds. The long-term goal of this     study is to evaluate a new approach for healing a chronic wound. Current methods of directly     applying substances that are involved in wound healing to a chronic wound do not cause enough     healing. PDGF-B (platelet-derived growth factor B), a factor associated with wound healing,     might dramatically enhance healing if a genetically engineered virus is injected into the     wound that causes cells in the wound to produce PDGF-B in large quantities.   "
161462|NCT00000448|"     This study will assess naltrexone's effectiveness in treating alcoholism in women and provide     information on its potential value in treating eating disorders common among alcoholic women.     Alcoholic women with and without both eating disorders and depression will be randomly     assigned to placebo or naltrexone treatment. Each group will receive behavioral therapy for     12 weeks, with followup 6 months after treatment.   "
162205|NCT00002075|"     To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in     combination with flucytosine, as treatment for acute cryptococcal meningitis.   "
161446|NCT00000432|"     This is a large study of an educational program on Lyme disease prevention for passengers on     ferry boats going to Nantucket Island during the period from Memorial Day until Labor Day.     Some boats provide passengers with the experimental program and the other boats provide a     control program that the researchers can compare to the experimental program. The     experimental program uses live performances by entertainers to teach people about Lyme     disease prevention, and also uses additional printed materials. People on the control boats     receive education on injury prevention and road safety while bicycling, rollerblading, and     using mopeds. The main result we will look for is Lyme disease identified by a followup     survey and confirmed by reviewing medical records. We will also ask some people to take part     in a smaller study of behavior change. In this study, we will ask people to complete forms on     self-efficacy (a person's belief in his or her ability to reach a certain goal), their plans     to take preventive steps, and actual prevention behaviors. We also ask participants who     report doctor visits or illness to provide confirmation of their use of health services.   "
161447|NCT00000433|"     The Division of Rheumatology at University of California San Francisco is conducting a     research study on the treatment of ankylosing spondylitis (AS) with a new therapy currently     used for people with other forms of arthritis. The drug, called Enbrel (or etanercept), is a     protein that is given twice weekly by injection underneath the skin. It blocks the action of     tumor necrosis factor-alpha (TNF-alpha), a substance that may be involved in AS, rheumatoid     arthritis, and other inflammatory conditions. We will randomly assign patients to receive     either the drug or a placebo (inactive treatment) for 4 months. The results we will monitor     include morning stiffness, spinal mobility, activities of daily life, and safety of the drug.   "
161448|NCT00000434|"     Previous studies have found that exercise can reduce pain, improve endurance for physical     activities, and improve cardiovascular fitness over time. However, these studies have not     looked at the impact of exercise programs for older adults with osteoarthritis or at how long     older adults continue exercising after a program is finished. This study will look at the     long-term effects of a structured exercise program for people aged 60 or older who have     osteoarthritis of the hip or knee. One goal of the exercise program is to encourage older     people with osteoarthritis to continue exercising.      We will randomly assign study participants to either the exercise program or a control group     that does not do the exercise program. We will monitor participants at the start of the     study, at 8 weeks, and every 3 months for 2 years after the program is completed. The     exercise program lasts for 8 weeks and includes an exercise part and an educational part led     by trained physical therapists. We believe that participants in the treatment (exercise)     group will show higher rates of continued exercise and higher functional status over time     compared to the group of people who do not participate in the exercise program.   "
161449|NCT00000435|"     A small protein called dnaJ peptide may help people with rheumatoid arthritis (RA) by     preventing their immune system cells from attacking their own tissues. The purpose of this     study is to determine if small amounts of dnaJ peptide can re-educate immune cells in     people with RA so that the cells stop attacking joint tissues.   "
161450|NCT00000436|"     This project will assess the effectiveness of a novel approach involving patient education     and strength training to improve functional recovery after a hip fracture. Participants will     be randomly assigned to one of two study groups. One group (control group) will receive     standard medical care. The other group will participate in a program of patient education and     strength training, including an at-home walking program.   "
161451|NCT00000437|"     The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched     placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in     reducing drinking and smoking in patients with both nicotine and alcohol dependence.   "
161452|NCT00000438|"     This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating     alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of     their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge,     individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or     a placebo. This part of the study will last 12 weeks, with regular measurements of drinking     level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of     the study.   "
161453|NCT00000439|"     The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in     treating individuals with alcohol dependence and comorbid bipolar disorder.   "
161454|NCT00000440|"     This study is a double-blind, placebo-controlled outpatient trial to improve, through the     addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent     individuals currently taking naltrexone (Revia).   "
161540|NCT00000527|"     To determine whether recurrent stenosis following carotid endarterectomy could be reduced by     pre- and post-operative oral administration of platelet-inhibiting drugs.   "
161459|NCT00000445|"     This 12-week trial will compare individuals receiving naltrexone or placebo plus substance     abuse counseling therapy versus those receiving only substance abuse counseling therapy in a     rural, nonacademic setting. A followup period of 12 months is included. The effect on service     utilization and the cost of the addition of naltrexone to treatment services for alcohol     dependence also will be assessed. The study will expand existing research concerning the     effectiveness of naltrexone in clinical trials versus a clinical setting.   "
161460|NCT00000446|"     This study will investigate the use of sertraline (Zoloft) to decrease alcohol consumption     and crime-related post-traumatic stress disorder in those individuals with both disorders.     This will be a 12-week, placebo-controlled, double-blind outpatient trial.      All subjects will receive cognitive behavioral therapy in addition to a placebo or     sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and     6, 9, and 12 months after study entry.   "
161461|NCT00000447|"     This study will develop a behavioral and drug relapse prevention program for individuals who     are dependent on both alcohol and tobacco. The study's goal is to show that individuals     receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have     higher rates of abstinence from both smoking and drinking than individuals who do not receive     the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with     followup assessments 1, 3, and 6 months after treatment.   "
161463|NCT00000449|"     The study's purpose is to improve alcoholism treatment by investigating the combined     effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET)     with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or     a control treatment as inpatients followed by 12 consecutive weeks of receiving either     naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is     completed.   "
161464|NCT00000450|"     The purpose of this study is to determine the long-term effectiveness of naltrexone treatment     in alcohol-dependent patients who respond to short-term treatment. Those who respond to     short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled     maintenance phase with a 6-month posttreatment followup.   "
161465|NCT00000451|"     This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in     Alaska natives with alcohol dependence. The study will also examine whether a combination of     naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone.     Alaska Native individuals will be recruited into a 16 week outpatient study.   "
161466|NCT00000452|"     The long-range goal of this ongoing research program is to find more effective treatments for     alcohol dependence by combining medication with the appropriate psychosocial support. This     proposal has three specific aims: (1) to compare the effectiveness of naltrexone (Revia) in     three types of treatment settings; (2) to assess the effects of psychosocial support on     medication compliance and treatment retention; and (3) to investigate the individual     characteristics that may predict who is likely to benefit from additional psychosocial     support versus simple medication management.   "
161467|NCT00000454|"     This study is designed to increase understanding of the processes that affect the treatment     outcome of individuals with both alcohol and nicotine dependence. Treatment outcome     methodology will be combined with a computerized self-monitoring methodology to examine the     extent to which smoking serves as a cue for alcohol craving and/or as a response to alcohol     craving in treated alcoholics. Subjects will be veterans participating in the Substance Abuse     Day Programs at the Newington and West Haven campuses of the VA Connecticut Healthcare     System. Nonveteran women will be recruited from the community and enrolled in the day     program. Subjects will be randomly assigned to one of the following two conditions: (1)     intensive smoking cessation therapy (counseling plus nicotine replacement using nicotine     patches) concurrent with alcohol treatment, or (2) brief smoking cessation advice concurrent     with alcohol treatment.   "
161468|NCT00000455|"     Early problem drinkers are prevalent in the United States. Recent controlled trials have     shown that brief interventions in the primary care setting can reduce drinking and     alcohol-related problems in patients who lack evidence of alcohol dependence.      Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few     pharmacotherapy studies have been undertaken with early problem drinkers. This study is an     8-week trial of naltrexone versus placebo, combined with coping skills treatment that either     focuses on targeted use of medication or serves as background to daily use of the medication.     A total of 160 early problem drinkers recruited through screening in primary care medical     settings will be randomly assigned to one of four treatment groups. Followup evaluations will     be conducted at the end of treatment and again 3, 6, and 12 months.   "
161469|NCT00000456|"     This study will compare cognitive behavioral therapy with a time-limited motivational     enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this     randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence,     will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo     for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse     will be evaluated in all four groups along with measures of alcohol craving, biological     measures of alcohol consumption, drinking consequences, changes in self-confidence for     avoiding alcohol, and medication compliance. All study participants will be assessed for     measures of outcome variables at 3 and 6 months after completing the treatment protocol.   "
161470|NCT00000457|"     This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing     the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from     smoking with nicotine patch therapy. The study will also determine the cessation rate in the     8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is     projected to serve as a 100-percent replacement.   "
161541|NCT00000528|"     To determine if nonpharmacological interventions, including diet and lifestyle change, could     prevent increases in arterial blood pressure leading to systemic hypertension.   "
161474|NCT00000461|"     To determine by sequential coronary arteriography whether a lipid-lowering diet with and     without lipid-lowering drugs could reverse coronary artery disease in normocholesterolemic     patients. Also, to test whether fish oil supplements could improve human coronary     atherosclerosis. Finally, to determine the effect of combination therapy with lipid-reducing     drugs in patients with coronary heart disease and normal cholesterol levels. At least three     clinical trials were conducted.   "
161475|NCT00000462|"     To assess the relative long-term safety and efficacy of percutaneous transluminal coronary     angioplasty (PTCA) and coronary artery bypass graft (CABG) surgery in patients with     multivessel disease and severe angina or ischemia who required revascularization and had     coronary anatomy suitable for either procedure.   "
161476|NCT00000463|"     To determine the relative effectiveness of moderate versus more aggressive lipid lowering,     and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass     graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous     vein coronary bypass grafts placed 1 to 11 years previously.   "
161477|NCT00000464|"     To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals     who had survived one episode of out-of-hospital cardiac arrest.   "
161478|NCT00000465|"     To compare the efficacy of coronary artery bypass graft (CABG) surgery with percutaneous     transluminal coronary angioplasty (PTCA) in patients with multiple vessel coronary heart     disease.   "
161518|NCT00000505|"     In TIMI I, to assess the relative thrombolytic activity and side effects of intravenous     recombinant tissue-type plasminogen activator (rt-PA) versus intravenous streptokinase in     patients with acute myocardial infarction. In TIMI II, to assess whether intravenous rt-PA     given in the early hours of acute myocardial infarction should be followed by percutaneous     transluminal coronary angioplasty (PTCA).   "
161479|NCT00000466|"     To assess the effects of various postmenopausal estrogen replacement therapies on selected     cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood     pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in     collaboration with the National Institute of Child Health and Human Development, the National     Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of     Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended     follow-up is for 3 years focusing on endometrium and breast evaluation.   "
161480|NCT00000467|"     To assess the effectiveness of school-based risk reduction interventions involving three     components: environmental changes related to food consumption, physical activity, and smoking     policy in the school; classroom curriculum; and family and home-based education.   "
161481|NCT00000468|"     To determine the practicality, benefit, and safety of paramedic administration of     thrombolytic therapy for acute myocardial infarction. The feasibility of paramedics correctly     identifying candidates for thrombolytic therapy following myocardial infarction was assessed     in Phase I. In Phase II, pre-hospital thrombolytic therapy was compared with in-hospital     thrombolytic therapy.   "
161482|NCT00000469|"     To determine whether warfarin or lovastatin alone or in combination retarded the progression     of atherosclerotic plaques in the carotid arteries of high risk individuals with asymptomatic     carotid stenosis. Also, to determine if a full scale trial was feasible.   "
161483|NCT00000470|"     To compare the influence of two surgical anesthetic techniques, hypothermia with circulatory     arrest or hypothermia with low-flow bypass perfusion, on neurologic functioning in infants     undergoing heart surgery.   "
161484|NCT00000471|"     To assess long-term effects of a strict lifestyle change program on lipids, blood pressure,     myocardial perfusion, and coronary atherosclerosis.   "
161485|NCT00000472|"     The Thrombolysis in Myocardial Ischemia Trial (TIMI III) focused on unstable angina and     non-Q-wave myocardial infarction. The trial was designed to determine by coronary     arteriography the incidence of coronary thrombi in these conditions and the response of these     thrombi to tissue-type plasminogen activator (t-PA) in TIMI IIIA and the effects of     thrombolytic therapy and of an early invasive strategy on clinical outcome in TIMI IIIB.     There was also a registry with two components. A roster enumerated all patients with unstable     angina or non-Q-wave myocardial infarction enrolled at cooperating hospitals. From the     roster, a study population of 1,893 subjects was selected and followed prospectively for the     year to determine incidence of death or myocardial infarction.   "
161486|NCT00000473|"     To determine whether a dietary supplement of n-3 polyunsaturated fatty acids (PUFAs) derived     from fish oil would decrease the restenosis rate in patients undergoing percutaneous     transluminal coronary angioplasty (PTCA).   "
161487|NCT00000474|"     To evaluate the long-term effect of reduction of alcohol intake on blood pressure in moderate     but non-dependent drinkers with mild hypertension or high normal blood pressure.   "
161488|NCT00000475|"     To assess the impact of a multidisciplinary treatment program on three-month readmission-free     survival in elderly congestive heart failure patients.   "
161489|NCT00000476|"     To determine if digitalis had a beneficial, harmful, or no effect on total mortality in     patients with clinical heart failure and sinus rhythm.   "
161490|NCT00000477|"     To conduct a pilot study to determine whether lowering elevated serum cholesterol levels with     3-hydroxy-3-methyl-glutaryl coenzyme A (HMG CoA) reductase inhibitors reduced mortality due     to the sequelae of atherosclerotic cardiovascular disease in older men and women.   "
161491|NCT00000478|"     To assess the feasibility of and test the methodology for a full-scale clinical trial of     therapies for asymptomatic cardiac ischemia.   "
161492|NCT00000479|"     The purpose of this study is to evaluate the effects of low-dose aspirin and vitamin E in     primary prevention of cardiovascular disease and cancer in apparently healthy women.   "
161493|NCT00000480|"     To determine the value of electrophysiologic (EP)-guided antiarrhythmic therapy in coronary     heart disease patients at increased risk for sudden death. The study included a controlled     clinical trial and a registry.   "
161494|NCT00000481|"     To evaluate the feasibility of recruiting women of different socioeconomic status and     minority groups and to determine whether these women could achieve and maintain a modified     fat-eating pattern. The full-scale trial sought to determine whether a low-fat diet could     decrease the incidence of cancer and coronary heart disease in postmenopausal women. The     National Heart, Lung, and Blood Institute contributed funds over a three-year period to     measure lipids, lipoproteins, and other cardiovascular disease risk factors.   "
162260|NCT00002130|"     To examine the continued safety and tolerability of four doses of vesnarinone in HIV-infected     patients who have completed a short-term study (less than 12 months on continuous treatment)     of the drug.   "
161495|NCT00000482|"     To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic     acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result     in significant reduction in total mortality over a five year period. Secondarily, to     determine whether the degree to which these drugs changed serum lipids was correlated with     any effect on mortality and morbidity rates; to gain further information on the long-term     prognosis of myocardial infarction (by studying the control group as intensively as the     treatment group); to acquire further experience and knowledge concerning the techniques and     methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of     aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.   "
161496|NCT00000483|"     To determine whether there were any long term sequelae of the drugs used in the Coronary Drug     Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).   "
161497|NCT00000484|"     To determine whether the long-term treatment of essential hypertension without significant     target organ disease materially influenced mortality and/or cardiovascular renal morbidity.   "
161514|NCT00000501|"     To test the feasibility and the efficacy of nutritional interventions in the primary     prevention of hypertension in individuals predisposed to the development of hypertension;     specifically, to test the hypothesis that reduction of weight and/or decreased sodium intake     in obese individuals, or decreased sodium intake with or without increased potassium intake     (in men and women, regardless of weight) would prevent the elevation of blood pressure and     the incidence of hypertension.   "
161498|NCT00000485|"     To determine the effectiveness of systematic, sustained, antihypertensive therapy in reducing     morbidity and mortality from hypertension in a wide spectrum of persons with elevated blood     pressure in 14 communities. During its course, the trial also obtained a direct measure of     the prevalence, severity, and treatment status of representative white and black populations     with high blood pressure in these 14 communities, and obtained an estimate of the extent of     attainable reduction of complications of high blood pressure by an organized screening and     blood pressure management program.   "
161499|NCT00000486|"     To compare the efficacy of medical or surgical (coronary artery bypass graft) therapy with     regard to survival and quality of life in patients with unstable angina and requisite     coronary anatomy as defined by angiography.   "
161500|NCT00000487|"     To determine for a group of men at high risk of death from coronary heart disease whether a     special intervention program to lower serum cholesterol, reduce blood pressure, and eliminate     cigarette smoking would result in a significant reduction in mortality from coronary heart     disease.   "
161501|NCT00000488|"     To determine whether reduction of cholesterol by drug therapy significantly lowered the     atherosclerotic coronary heart disease rate in a group of hypercholesterolemic but otherwise     healthy men.      Total dollars spent on the CPPT from June 1973 were $142,250,000. We do not have a     year-by-year breakdown.   "
161502|NCT00000489|"     To compare coronary artery surgery with medical management in patients with coronary artery     disease and to maintain a registry on all patients undergoing coronary arteriography, whether     operatively or medically managed.   "
161503|NCT00000490|"     To determine whether a profound reduction in serum cholesterol level, induced and maintained     by partial ileal bypass, would prevent a second heart attack among men and women who had one     myocardial infarction and whose blood cholesterol could not be reduced sufficiently by diet.   "
161504|NCT00000491|"     To determine whether the daily administration of 1 gm of aspirin to individuals with a     documented myocardial infarction would result in a significant reduction in mortality over a     three year period.   "
161505|NCT00000492|"     To determine whether the regular administration of the beta-blocker drug propranolol to     people who had had at least one documented myocardial infarction would result in a     significant reduction of mortality from all causes over the follow-up period. Eligible     volunteer patients were recruited to participate in a double-blind clinical trial within 21     days after the onset of the acute event. One-half of the patients were randomly assigned to a     beta-blocking drug (propranolol) and one-half to a placebo. The trial also evaluated the     effect of propranolol on incidences of coronary heart disease mortality, sudden cardiac     death, and nonfatal myocardial infarction plus coronary heart disease mortality in persons     with documented previous myocardial infarction.   "
161506|NCT00000493|"     To assess the ability of two separate therapeutic interventions, propranolol and     hyaluronidase, to limit the ultimate size of an acute myocardial infarction. A secondary     objective was to assess the influence of these therapies upon ventricular function and     morbidity following myocardial infarction.   "
161507|NCT00000494|"     To evaluate the effects (up to one year of age) of indomethacin on the clinical course of     patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the     relative merits of indomethacin and surgery in infants with persistent respiratory distress     who were not treated early with indomethacin. Two concurrent trials were performed.   "
161508|NCT00000495|"     To determine whether improved nutrition to correct overweight and high sodium intake, and     regular frequent moderate rhythmic exercise to improve cardio-pulmonary fitness and to slow     heart rate could lower blood pressure and prevent development of hypertension in     hypertension-prone individuals.   "
161509|NCT00000496|"     To determine the effectiveness of the platelet inhibitor drugs dipyridamole and aspirin in     reducing the angiographic progression of coronary artery disease over a five-year period and     to test the predictive value of the platelet survival half-life in identifying patients with     more rapid progression of coronary disease and development of its complications.   "
161510|NCT00000497|"     The primary objective of this multicenter cooperative clinical trial was to determine if     dietary modification would enable drug controlled hypertensive patients to remain at 'goal     blood pressures' after antihypertensive medication was withdrawn. The proposal made use of     the HDFP hypertensive population who had five years of treatment for their hypertension.     Additionally, the group of investigators proposed to determine if dietary treatment would     permit patients not previously adequately controlled under the HDFP program to achieve     normalization of blood pressure with a combination of dietary modification and drug     treatment. The study also proposed to search for predictors (i.e., levels of hormonal agents     such as plasma renin activity) of responsiveness to dietary manipulation among the     hypertensive population as well as to identify psychological attributes that might be of     importance in managing these patients.   "
161511|NCT00000498|"     To determine whether blood pressure could be controlled by nutritional-hygienic,     non-pharmacologic means in hypertensives treated with drugs in the Hypertension Detection and     Follow-up Trial (HDFP).   "
162261|NCT00002131|"     To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related     Kaposi's sarcoma.   "
161512|NCT00000499|"     The SHEP Pilot Study had six objectives, each designed to develop and test critical     components of a full scale trial directed at the health consequences of treating isolated     systolic hypertension (ISH) in the elderly.      l. To estimate and compare the yield of participants for randomization into a clinical trial     from various community groups using various recruitment techniques.      2. To estimate compliance with the visit schedule and to the prescribed double-blind     regimens.      3. To estimate and compare the effectiveness of specified antihypertensive medications in     reducing the blood pressure.      4. To estimate and compare the unwanted effects of specified antihypertensive medication in     an elderly population.      5. To evaluate the feasibility and effectiveness of periodic behavioral assessment in this     population.      6. To develop and test methods of ascertaining stroke and other disease endpoints.   "
161513|NCT00000500|"     To assess the effect on cardiovascular mortality of alternate-day consumption of 325     milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day     consumption of 50 milligrams of beta-carotene.   "
161526|NCT00000513|"     The objective of the Trial of Antihypertensive Intervention Management (TAIM) was to     determine the efficacy of dietary management and/or drug therapy, namely thiazide-like     diuretics or a beta-blocker, in the control of mild hypertension. Additionally, the     Continuation of the Trial of Antihypertensive Intervention Management (COTAIM) tested the     effects of long-term weight reduction, and sodium/potassium changes added to weight     reduction, as well as the original drug treatment, on the failure rate of blood pressure     control.   "
161527|NCT00000514|"     The primary objective was to assess whether long-term administration of antihypertensive     therapy to elderly subjects with isolated systolic hypertension reduced the combined     incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the     effect of long-term antihypertensive therapy on mortality from any cause in elderly people     with isolated systolic hypertension; possible adverse effects of chronic use of     antihypertensive drug treatment in this population; the effect of therapy on indices of     quality-of-life; the natural history of isolated systolic hypertension in the placebo     population.   "
161528|NCT00000515|"     To determine the effects on blood pressure of dietary intervention, restricting caloric     intake to 600 calories per day for 16 weeks compared to a control diet of 1200 calories per     day in obese hypertensives. Secondary aims included a study of psychological characteristics     at baseline and during the weight loss and maintenance phases of the study.   "
161529|NCT00000516|"     To determine if enalapril treatment of left ventricular dysfunction (LVD) due to ischemic or     hypertensive heart disease led to reduced mortality and morbidity in symptomatic and     asymptomatic patients. There were a Prevention Trial, a Treatment Trial, and a registry.   "
161530|NCT00000517|"     To determine the benefits and risks of oral anticoagulant therapy in reducing embolic stroke     and systemic emboli in patients with atrial fibrillation without rheumatic heart disease.   "
161531|NCT00000518|"     To determine whether electrophysiologic study (EPS) or Holter monitoring (HM) was the better     method for selecting effective long-term antiarrhythmic drug therapy in patients with     sustained ventricular tachycardia, ventricular fibrillation, or an episode of aborted sudden     death.   "
161532|NCT00000519|"     To determine the effects in moderately obese subjects of weight loss by combined dieting and     exercise training on risk factors for coronary artery disease including lipoprotein lipids,     apoproteins and blood pressure.   "
161542|NCT00000956|"     To evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope     glycoprotein gp160. To evaluate the duration of antibody response and its relationship to     dose and frequency of inoculation.      Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates     that, although serum anti-gp160 antibody responses were detected, the level and duration of     those responses were limited. A preliminary observation suggests that weak functional     antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a     dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.   "
161543|NCT00000957|"     To evaluate the safety and immune response to vaccinia-derived HIV-1 recombinant envelope     glycoprotein (gp160) using an accelerated dosage schedule; to evaluate duration of antibody     response and its relationship to the dose and frequency of inoculation.      Although recent advances have been made in antiviral therapy against AIDS, there is currently     no cure for AIDS. It is likely that ultimate control of the disease depends on the     development of safe and effective vaccines against HIV.   "
161544|NCT00000958|"     To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59     adjuvant in adult volunteers with HIV infection.      By vaccinating those who have HIV infection, perhaps the replication (reproduction) of     existing viral strains can be suppressed and the asymptomatic period early in the infectious     process can be prolonged. One potential way to do this is to boost HIV antigen-specific CD4     responses, which may in turn increase the effectiveness of CD8 killing of HIV infected cells.   "
161545|NCT00000959|"     To evaluate the safety and effectiveness of a 6-month course of isoniazid ( INH ) in the     prevention of clinical tuberculosis in anergic (having diminished or absent reactions to     specific antigens) HIV-infected persons who are at high risk for tuberculous infection.      A substantial number of HIV-infected persons are anergic, and thus do not respond to the only     currently available diagnostic tool for tuberculosis infection (that is, the PPD (purified     protein derivative) skin test). Many of these anergic persons are, however, infected with     Mycobacterium tuberculosis and eventually develop reactivation tuberculosis, causing both     individual illness and spread of infection to others in the community. This study examines     the possibility of using INH prophylaxis (that is, for prevention) in anergic HIV-infected     patients at high risk for tuberculosis as a means of decreasing the sharp rise in the     incidence of tuberculosis due to HIV infection. INH is inexpensive and relatively safe, and     thus may demonstrate an acceptable risk/benefit ratio as a medication that can be given over     a limited period of time to a population suspected of having, but not proved to have, M.     tuberculosis infection. If this study shows INH to be safe and effective in this setting, it     could have a major effect on public health in this country.   "
161546|NCT00000960|"     To determine whether the rate of HIV transmission from mother to infant can be reduced by     continuous oral zidovudine (AZT) treatment to HIV infected pregnant women, intravenous AZT     during childbirth, and oral AZT treatment of the newborn infant from birth to six weeks of     age. The study is also designed to evaluate the safety of AZT for both the pregnant woman and     the newborn infant.      No method exists to prevent transmission of HIV from an infected mother to her newborn     infant. Giving an antiviral agent (such as AZT) to the mother and to the newborn could in     theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to     maternal virus, or by preventive treatment of the fetus before exposure.   "
161547|NCT00000961|"     To determine the safety and tolerance of hyperimmune anti-HIV intravenous immunoglobulin     (HIVIG) and of zidovudine (AZT) in infants with established HIV infection; to get preliminary     evidence for the effectiveness of this type of treatment in preventing the advance of disease     in HIV infected infants. HIVIG may be an effective agent that either alone or in combination     with AZT will prevent progression of clinical disease.   "
162179|NCT00002049|"     Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus     isolation. Examine the ability of thymopentin to stimulate the immune system and alter the     clinical findings of patients infected with HIV who do not yet have AIDS.   "
161548|NCT00000962|"     To assess the safety and tolerance of multiple oral doses of Nevirapine (BI-RG-587). To     generate data on the pharmacokinetics and dose proportionality of Nevirapine with multiple     dosing. To characterize the pattern of virological activity in vivo. Improvement in     virological end points will be examined for association with dose and absorption. To     determine whether development of resistance is reflected in return of virological activity     and, if so, when markers reflect this resistance. To determine if improvements of     immunological endpoints are detectable in the number of patients studied. A compound free of     the toxic effects of nucleoside chain terminators such as zidovudine (AZT) may have an     advantage over currently available treatments for HIV infection. Such a compound has further     advantages if it is active against AZT-resistant isolates. Nevirapine (BI-RG-587) has shown     in vitro inhibitory activity against HIV-1 reverse transcriptase (RT). The molecular     mechanism of the RT inhibitory effect is hypothesized to be non-competitive inhibition due to     its binding to an RT site distinct from those for the RNA template primer, the     deoxynucleotide triphosphate or the RNase H catalytic site.   "
161549|NCT00000963|"     To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the     treatment of children with symptomatic HIV disease who have had to discontinue zidovudine     (AZT) because of intolerance and/or who have experienced progressive disease while on AZT.      The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The     benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for     approximately 12 to 18 months, at which time most patients have progressive deterioration.     Recently published literature has described a reduced sensitivity of HIV isolated from     patients after prolonged AZT treatment. Although the clinical significance of this is     unclear, it makes the development of new antiretroviral drugs important.   "
161550|NCT00000964|"     To see if ranitidine, by reducing stomach acidity, can enhance the effectiveness of     foscarnet, by making foscarnet more available to the body.      Foscarnet is an antiviral compound. Laboratory studies have shown it to be active against     HIV. However, only 12 - 22 percent of an oral foscarnet dose is absorbed by the body.     Ranitidine suppresses gastric acid output, increasing gastric pH. Thus by increasing gastric     pH (decreasing stomach acidity), less foscarnet is expected to be decomposed or broken down     in the stomach. Thus, more foscarnet should be absorbed into the body.   "
161551|NCT00000965|"     To define the pharmacokinetic parameters (blood levels) of total phosphorylated zidovudine     (AZT) in peripheral blood mononuclear cells (PBMC) from HIV-infected patients.      Despite an understanding of the serum (or plasma) pharmacokinetics (blood levels) of AZT, a     therapeutic concentration range and optimal dosing interval have not yet been determined.   "
161552|NCT00000966|"     To evaluate the effectiveness and toxicity of oral azithromycin and pyrimethamine as acute     therapy for toxoplasmic encephalitis in AIDS patients. To assess the toxicity and     effectiveness of azithromycin alone as maintenance therapy.      Encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous     system infection in patients with AIDS. Untreated, the encephalitis is fatal. Standard     treatment for toxoplasmic encephalitis is associated with serious adverse effects. Thus,     alternative treatments are needed.   "
161553|NCT00000967|"     PRIMARY: To determine the maximum tolerated dose of interferon-alfa (IFN-A) alone and in     combination with zidovudine (AZT); to assess the safety and tolerance of IFN-A alone and in     combination with AZT.      SECONDARY: To evaluate the effect of combination IFN-A and AZT on immunologic and virologic     parameters; to determine whether the pharmacokinetic parameters of AZT are modified by the     subcutaneous administration of IFN-A.      AZT is effective in suppressing the progression of HIV infection in patients without symptoms     or with AIDS or AIDS-related complex (ARC). However, use of AZT is limited by its frequent     toxicity, which sometimes relates to the amount of drug given. Thus, a combination treatment     of two drugs that work together may provide more effective and safer treatment. IFN-A is a     drug that has antiviral effects and may work well with AZT.   "
161554|NCT00000968|"     To determine the safety of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160)     in human volunteers; to evaluate the immunogenicity of this preparation in human volunteers.     Although recent advances have been made in antiviral therapy against AIDS, there is currently     no cure for AIDS. It is likely that ultimate control of the disease depends on the     development of safe and effective vaccines against HIV.   "
161555|NCT00000969|"     To evaluate and compare the effectiveness and toxicity associated with didanosine ( ddI ) and     zalcitabine ( dideoxycytidine; ddC ) in patients with HIV infection who are intolerant of or     have failed zidovudine ( AZT ) therapy.      Alternative and less toxic treatments need to be investigated for the treatment of HIV     infection. Studies have shown that the dideoxynucleosides ddI and ddC may be effective     antiretroviral agents in the treatment of HIV-infected individuals. However, ddI and ddC have     yet to be compared on the basis of patient survival, drug tolerance, immunologic and     virologic effectiveness, and the incidence of opportunistic infection or opportunistic     malignancy. Results of this study will yield information regarding the relative therapeutic     benefits and toxicities of each drug while providing alternative treatment to patients who     are unable to tolerate or have had progression of disease while on AZT.   "
161556|NCT00000970|"     To examine the safety and tolerance of the administration of ganciclovir and foscarnet given     together or alternately; to determine the interactive pharmacokinetics (blood level) profile     of long-term combined and alternating therapy with these two drugs. Additional objectives are     to examine the effect of these treatments in controlling time to cytomegalovirus (CMV)     retinitis progression and to examine the antiviral activity of combined and alternating     ganciclovir/foscarnet treatment and development of antiviral resistance. Sight-threatening     CMV retinitis occurs in at least 6 percent of AIDS patients. By 1991 (US), there may be 6000     to 10000 patients with CMV retinitis. Many clinical reports suggest that both ganciclovir     (DHPG) and foscarnet have an antiviral effect against CMV that is often associated with     clinical stabilization. Effectiveness of ganciclovir and foscarnet is correlated with weekly     maintenance and since toxicity is dose-limiting in up to 20 percent of patients receiving     either drug for long periods, it may be beneficial in long-term maintenance treatment to     combine or alternate these two drugs at a lower total weekly dose of each drug.      This strategy may result in a greater net antiviral effect with less toxicity than is seen     with either drug alone, because the toxicities of each drug are quite different.   "
161557|NCT00000971|"     To evaluate three doses of clarithromycin in children with AIDS and Mycobacterium avium     complex (MAC) infection who are receiving concurrent antiretroviral therapy.      Before more extensive evaluation of this promising drug for treatment of MAC infection in     children can be done, it is important to study the pharmacokinetics of this drug in this     population, to get information regarding its use in pediatric patients receiving currently     available antiretroviral drugs, and to get information on the antimycobacterial activity of     this drug.   "
161558|NCT00000972|"     To evaluate the safety of a fixed antigen dose with an increasing dose of adjuvant     (MTP-PE/MF59, a substance to enhance the immune response to vaccine) in volunteers. To     evaluate local and systemic reactions (Part A). To determine the safety and immunogenicity of     Env 2-3 in combination with MTP-PE/MF59 in volunteers (Part B). The vaccine Env 2-3 is     created from one of the viral proteins that make up HIV called envelope glycoprotein gp120. A     problem with many immunogens, including candidate HIV vaccines, is that they may evoke     relatively weak immune responses, particularly in humans and in nonhuman primates. Thus,     there is considerable interest in the development of adjuvants (substances that augment     immune responses to vaccines). MTP-PE/MF59 is an adjuvant that appears to be particularly     promising, and is selected for the studies with this HIV vaccine candidate.   "
161559|NCT00000973|"     To determine the manner in which pyrimethamine is metabolized and excreted in patients     currently receiving zidovudine (AZT). An important goal of this measurement is to establish     the optimal dose of pyrimethamine necessary to prevent the development of toxoplasmosis in     AIDS patients or delay the subsequent return of toxoplasmic encephalitis.      Encephalitis caused by Toxoplasma gondii has emerged as the most frequent cause of focal     central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal.     The best treatment for this disease has not been determined. Presently it is standard     practice to administer a combination of pyrimethamine and sulfadiazine. Little is known about     the pharmacokinetics of pyrimethamine in patients with AIDS receiving AZT. Furthermore, there     are reports that patients already exposed to toxoplasmosis may not have uniform absorption of     pyrimethamine.   "
162005|NCT00000996|"     To study the natural course of AIDS related Kaposi's sarcoma and to determine the usefulness     and safety of weekly administration of small doses of doxorubicin.      Doxorubicin is one of the most active of all antitumor agents but at currently used doses     toxicity is common. When small doses are administered on a weekly schedule, the toxicity of     the drug appears to be reduced.   "
162262|NCT00002132|"     To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets     for the treatment of esophageal candidiasis in immunocompromised patients.   "
161560|NCT00000974|"     To evaluate the delivery of a single dose of aerosolized pentamidine to children; to evaluate     the tolerance of pentamidine administration by mask; to compare intravenous pentamidine first     dose pharmacokinetics (blood levels) in children with information previously collected on     adults; and to compare plasma pentamidine levels in children after an aerosolized treatment     with levels previously collected on adults.      Pneumocystis carinii pneumonia (PCP) is the most common serious infection in children with     AIDS and is associated with a high death rate. Current approved treatment includes     intravenous trimethoprim - sulfamethoxazole (TMP / SMX) and intravenous pentamidine, which     are both effective in treatment of the first episode of PCP pneumonia. However, both     therapies have a 50 percent or greater incidence of adverse reactions. Because of serious     toxicities, drug treatment has had to be discontinued. Animal studies show that aerosolized     pentamidine (pentamidine given through inhalation) is as effective as intravenous     pentamidine. It is hoped that the aerosolized route will be less toxic than intravenous     pentamidine. The study is the first step in evaluating the delivery of aerosolized     pentamidine to children.   "
161561|NCT00000975|"     To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2)     maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of     CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy.      Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the     clinical response to amphotericin B treatment in the AIDS patients is generally good,     administration difficulties and toxicity detract from its usefulness. Oral treatment with     ketoconazole overcomes these limitations of amphotericin B, but does not appear to be     effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in     which preclinical studies have demonstrated activity against Histoplasmosis capsulatum.     Preclinical studies have also shown that itraconazole appears effective in the treatment of     histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several     studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with     histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole     has been used successfully in a small number of patients with cryptococcal meningitis,     supporting a study of its use in CNS histoplasmosis.   "
161562|NCT00000976|"     To determine the safety profile of recombinant human CD4-immunoglobulin G (CD4-IgG) and     zidovudine (AZT) combination therapy in patients with AIDS or AIDS-related complex (ARC); to     assess pharmacokinetic (blood level) properties of CD4-IgG in combination with AZT; and to     obtain preliminary indication of the antiviral and immunologic effects of CD4-IgG in     combination with AZT in patients with AIDS and ARC.      Treatment of AIDS has been directed toward the underlying retroviral infection as well as     toward specific opportunistic infections and malignancies that are associated with the     syndrome. The most extensively studied drugs are reverse transcriptase inhibitors such as AZT     and other nucleoside analogs, including didanosine (ddI) and dideoxycytidine (ddC). The most     extensive clinical experience has been achieved with AZT. These clinical trials indicated a     decreased incidence of opportunistic infection and increased survival in patients with AIDS.     However, AZT treatment is associated with dose-limiting toxicities. Additionally,     identification of resistance to AZT has increased the need to test the effectiveness of AZT     in combination with other drugs. CD4-IgG is capable of binding to HIV envelope protein     (gp120) and inhibiting HIV infectivity in test tube studies. Potential therapeutic benefit in     patients with HIV infection may be derived from CD4-IgG.   "
162180|NCT00002050|"     Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus     isolation. Examine the ability of thymopentin to stimulate the immune system and alter the     clinical findings in patients infected with HIV who do not yet have AIDS.   "
161563|NCT00000977|"     To determine the minimal effective (immunogenic) dose of vaccine in asymptomatic HIV-1     seropositive individuals with > 400 cells/mm3 (CD4). To determine the dose-response to a 4     fold escalation of the immunizing dose. To describe both cellular and humoral immune     responses to HIV-1 in the immunized individuals. To describe the effects of this immunization     on general immunological, virological and clinical parameters. To evaluate the safety of     injecting recombinant gp160 in this population. To evaluate the extent of variability between     different lots of gp160 (arms C1 and C2). It might be possible to increase immune responses     or to induce new types of immune responses to HIV in some infected individuals by means of a     vaccine, which could result in an immunological, virological or clinical benefit.   "
161564|NCT00000978|"     To determine the safety, tolerability, and activity of zidovudine (AZT) and zalcitabine     (dideoxycytidine; ddC) and the bloodstream levels of these drugs in patients with AIDS or     advanced AIDS-related complex (ARC).      Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal     of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and     ddC may work together in a way that both drugs can be taken at lower doses or less frequent     intervals when given together. If the doses can be reduced, then toxicity associated with     long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the     likelihood of the emergence of resistant mutants. Recent studies indicate a reduced     sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical     significance of this finding is not clear, it would indicate that these combination studies     are all the more important. HIV strains with decreased sensitivity to AZT are still sensitive     to ddC.   "
161565|NCT00000979|"     To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in     patients with AIDS, advanced AIDS-related complex (ARC), or asymptomatic infection with CD4     counts < 200 cells/mm3.      AZT is effective in reducing mortality in patients with AIDS who receive the drug after the     first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC.     However, AZT therapy has been associated with significant toxicities. In addition, the     effectiveness of AZT appears to decrease during the second and third years of therapy. For     these reasons, the development of alternative therapy that would be at least as effective but     less toxic is of great importance. The drug ddI is an antiviral agent that inhibits     replication (reproduction) of HIV with less apparent toxicity than AZT.   "
161566|NCT00000980|"     To determine the safety and effectiveness of intravenous spiramycin in patients with     AIDS-related cryptosporidial diarrhea.      Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment     of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the     symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed     no significant difference between spiramycin and placebo (inactive medication). A later study     indicated that the absorption of spiramycin is significantly decreased when food is present.     Thus, the results of the trial may have been due to poor absorption of spiramycin.   "
161567|NCT00000981|"     To find oral doses of FIAC (a pyrimidine nucleoside analog) that are effective in treating     cytomegalovirus (CMV) viremia in HIV-infected immunocompromised patients; to determine     tolerance and safety of FIAC in this patient population; and to determine pharmacokinetics     following multiple doses of FIAC. (An example of another nucleoside analog effective against     retroviruses such as HIV is zidovudine (AZT).) CMV infection is a medically significant     opportunistic disease in patients with HIV-related infection. The purine nucleoside     ganciclovir has been used to treat AIDS patients with CMV disease. Although ganciclovir is     useful in treating CMV disease, such treatment is frequently complicated by hematologic     (blood) toxicity. Also, treatment is difficult because it requires daily intravenous dosing.     Test tube studies show that FIAC and its primary breakdown product FIAU are highly and     specifically active against several viruses including CMV. A single-dose, pharmacokinetic     (blood level) study showed that FIAC, when taken orally, is readily absorbed into the     bloodstream, and most of it is converted to FIAU.   "
161568|NCT00001106|"     AMENDED: To evaluate the pharmacokinetics of intravenously administered AZT to HIV-1 infected     pregnant women in labor; to evaluate the pharmacokinetics and urinary excretion of AZT and     its metabolites in newborns of HIV-1 infected mothers who receive IV AZT only during labor;     to evaluate the safety of IV AZT administered by continuous infusion to HIV-1 infected     laboring women and their infants. Original design: To determine the distribution and     elimination of zidovudine (AZT) in the body as well as its safety in the treatment of     pregnant women and their unborn children. The information derived from this study is required     in order to design a future study that will assess the efficacy of AZT in reducing the     transmission rate of HIV-1 from seropositive women to their fetus by treating them during the     third trimester of pregnancy.      An estimated 30 percent to 40 percent infected pregnant women risk transmission of HIV-1 to     their infants, whether they be symptomatic or asymptomatic. Zidovudine (AZT) has previously     demonstrated its effectiveness as a potent inhibitor of HIV replication in vitro and in adult     patients; benefits of treatment include decreased mortality rate, decreased incidence of     opportunistic infections, and increased number of CD4 cells. Phase I AZT studies in children,     however, have resulted in uncontrolled information regarding clinical efficacy. The present     study, therefore, will investigate the safety and pharmacokinetics of intravenous (IV) and     oral AZT administration to HIV-1 infected pregnant women in the 3rd trimester, as well as the     safety and efficacy of such treatment in their newborns.      It is hoped that the results will be instrumental in designing future studies to assess the     efficacy of AZT in reducing the transmission risk of HIV-1.   "
161569|NCT00001107|"     The purpose of this study is to compare the safety and effectiveness of 2 treatments to     prevent invasive fungal infections (IFI), which are infections caused by yeasts and molds     that are common in patients with weak immune systems or transplant patients. AmBisome, a new     treatment, will be compared to fluconazole, the traditional treatment for fungal infections     caused by the yeast Candida. Treatment will only be given to liver transplant patients who     are found to be at high risk for IFI. Liver transplant patients who are at low risk for IFI     will be monitored but will receive no study medication.      IFIs are found mainly in a high risk group of liver transplant patients, and are not common     in those with low risk. If IFI preventive therapy is focused on the high risk group, there     may be a lesser chance of Candida becoming resistant (able to grow despite the presence of     drugs used to kill it). Treating only the high risk group will also save money.   "
161570|NCT00001108|"     The purpose of this study is to see if 7 drugs, some of them given at higher doses than     normal, are safe and tolerated by young patients with AIDS who have failed to respond to     other treatments. The study will also see what effect taking several anti-HIV drugs together     at high doses has on the body's ability to fight HIV infection. The 7 drugs that will be     given in this study are stavudine (d4T), didanosine (ddI), lamivudine (3TC), nelfinavir     (NFV), ritonavir (RTV), saquinavir (SQV), and nevirapine (NVP).      (This study has been changed from an 8-drug regimen to a 7-drug regimen. Patients no longer     receive the drug hydroxyurea [HU].) Doctors are seeing many HIV-positive children who did not     get good long-term results from the current anti-HIV drugs. Some doctors believe anti-HIV     drugs fail because drug levels in the body are too low. In this study, doctors will give     patients 7 drugs, some at higher doses than normal. Since it is very important that patients     on the study take all of these drugs, doctors will make it as easy as possible. Doctors want     to try this because children with advanced AIDS have few treatment choices.   "
161571|NCT00001109|"     The purpose of this study is to learn more about some of the immune cells in the blood (CD4     cells, for example) of healthy children in order to better understand the differences in the     blood cells of children infected with HIV.      Because children's bodies are still developing, their cells are different from those of     adults, and their bodies respond differently to infections such as HIV. In order to     understand how immune cells grow and mature so that they can fight HIV, it is important to     see how these cells behave in normal children.   "
161572|NCT00001110|"     The purpose of this study is to see: (1) how the amount of HIV in the lungs compares to that     in the blood; (2) if HAART reduces the amount of HIV in the lungs; and (3) if HAART reduces     lung inflammation in HIV-infected patients.      Lung-cell inflammation in HIV-infected patients is probably caused by HIV infection of these     cells. The amount of inflammation may correspond to the amount of HIV (viral load) in the     lungs (i.e., mild inflammation indicates a low amount of HIV; severe inflammation indicates a     high amount of HIV). HAART is used to decrease the amount of HIV in the body. If HAART is     able to decrease viral load in the lungs, it should also be able to decrease lung-cell     inflammation in these patients.   "
161581|NCT00001119|"     The purpose of this study is to find out whether these powerful combinations of anti-HIV     drugs are safe and effective for use in patients in the early stages of HIV infection and to     find out how patients' immune systems react to HIV and anti-HIV drugs.      Doctors generally treat patients in the early stages of HIV infection with the same anti-HIV     drugs taken by patients who have had HIV for a long time. These drugs lower the level of HIV     in the blood. However, doctors do not know whether patients who take anti-HIV drugs in the     early stages of HIV infection actually live longer or have fewer AIDS-related diseases. This     study will help doctors answer these questions. In the main study, doctors will look at how 2     different anti-HIV drug combinations affect the immune system. In the 2 substudies, doctors     will look at how the body reacts to the hepatitis B vaccine and the tetanus vaccine. These     substudies may help doctors learn how HIV-infected patients respond to new infections.   "
161573|NCT00001111|"     Monotherapy phase: To evaluate and compare the safety, tolerance, pharmacokinetics, and     preliminary activity of nevirapine administered alone in mildly to moderately symptomatic     HIV-infected children ages 2 months to less than 18 years; to evaluate and compare the     safety, tolerance, and pharmacokinetics of nevirapine in HIV-infected children ages 1 day to     less than 2 months. Combination therapy phase: To evaluate and compare the safety, tolerance,     pharmacokinetics, and preliminary activity of nevirapine administered in combination with     zidovudine (AZT) in mildly to moderately symptomatic HIV-infected children ages 2 months to     less than 18 years.      Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic     than the nucleoside analogues are needed. Nevirapine (BI-RG-587) has shown in vitro     inhibitory activity against HIV-1reverse transcriptase and has shown a synergistic inhibition     of HIV-1 replication when combined with zidovudine (AZT) in a plaque reduction assay.   "
161574|NCT00001112|"     To find out which of four doses of (recombinant) human interferon gamma (IFN-G) is most     effective in stimulating the white blood cells (monocytes) to fight infection and to see if     treatment with IFN-G can strengthen the ability of AIDS patients to control infections. This     study will also determine how long after a single injection of IFN-G white blood cells remain     stimulated.      AIDS is a disease that progressively destroys that aspect of the body's defense called the     immune system. It is particularly harmful to a class of cells called helper T-lymphocytes.     The specific opportunistic infections and malignancies associated with AIDS have been treated     with therapies that are often poorly tolerated by the patients and are associated with     dose-limiting toxicities. The principal focus of AIDS therapy research at present is to     control the underlying retroviral infection and to restore immune function with recombinant     lymphokines, adoptive immunotherapy, and/or lymphocyte transplants. These treatments include     zidovudine (AZT), which has been shown to control the HIV infection, and IFN-G, a lymphokine     which activates tumor-destroying and germ-killing functions. Studies are needed to find the     dose by which IFN-G works best.   "
161575|NCT00001113|"     To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's     sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon     alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics     of AZT and IFN-A or AZT and IFN-A2A when given in combination. To define the maximum     tolerated dose (MTD) of each drug in combination and to define doses to be used in Phase II     trial. AZT has been found to be effective against the effects of HIV in vitro (test tube) and     both interferons have shown antiviral and antitumor effect on Kaposi's sarcoma. It is     reasonable to assume that a synergism and an enhanced antitumor response may be seen with     combination therapy. A study to evaluate the safety and effectiveness of AZT in the     combination with IFN-A2A is warranted.   "
161588|NCT00001127|"     This study tests the safety and effectiveness of a flu vaccine in school children.      School children are usually the first members of a community to come down with the flu, and     they often give the flu to their younger siblings, parents, and grandparents. It is hoped     that giving school children a flu vaccine can help prevent the spread of the flu to other     members of the community.   "
162181|NCT00002051|"     Examine the ability of thymopentin (Timunox) to:      Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter     the clinical findings in patients infected with HIV who do not yet have AIDS.   "
161576|NCT00001114|"     Primary: To evaluate the safety, toxicity, and antitumor activity of two doses of interferon     alfa-2b (IFN-alpha) combined with a fixed dose of didanosine (ddI) in patients with Kaposi's     sarcoma associated with HIV infection.      Secondary: To evaluate the effects of combined IFN-alpha and ddI treatment on HIV expression     and markers of immune function.      Previous studies have shown that IFN-alpha can induce regression of Kaposi's sarcoma and     suppression of HIV in some patients. Although various trials using IFN-alpha in combination     with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity     and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia) of these     two agents has proven dose-limiting. The toxicity profile of ddI suggests that this drug may     be better tolerated than zidovudine when combined with IFN-alpha.   "
161577|NCT00001115|"     Part A: To evaluate the impact of HSV suppression with acyclovir ( ACV ) on HIV burden in     patients with asymptomatic HSV infection and at high risk for HSV reactivation.      Part B: To characterize the change in plasma HIV RNA levels and other measures of HIV burden     during and after a 10 day course of ACV treatment for acute HSV infection.      Approximately 70% of patients infected with HIV are concurrently infected with HSV. There is     new evidence to suggest that HSV may act as a co-factor in HIV disease progression. This     study will attempt to determine if the upregulation of HIV RNA that occurs during symptomatic     HSV reactivation also occurs during asymptomatic HSV reactivation and if suppression of HSV     will result in decreased levels of HIV RNA. There is a need to determine the patterns of     association between HSV and HIV.   "
161578|NCT00001116|"     The purpose of this study is to determine if TNFR:Fc (a molecule that attaches to TNF) can     lower the amount of IL-6 in HIV-positive patients. This study will also examine the effect of     TNFR:Fc on TNF-alpha. IL-6 and TNF-alpha are 2 substances produced by the immune system that     may increase the rate of HIV replication.      IL-6 and TNF-alpha are produced naturally by the body. High levels of TNF-alpha lead to     increased IL-6 production and increased HIV replication, therefore helping the virus infect     the body. HIV-positive patients who receive IL-2 (interleukin-2, a protein that helps the     immune system fight infection) tend to have higher levels of IL-6 and TNF-alpha than patients     not receiving IL-2. These increased levels may contribute to some of the flu-like symptoms     related to IL-2 administration. TNFR:Fc can neutralize TNF-alpha to decrease the action of     TNF-alpha and, in turn, decrease the amount of IL-6 in the body. TNFR:Fc may, therefore, have     a role in the treatment of HIV disease or in relieving some of the symptoms related to IL-2     administration.   "
161579|NCT00001117|"     This study evaluates patients infected with both HIV and Hepatitis C virus (HCV) who are     receiving anti-HIV drugs. The purpose of this study is to learn more about HCV infection in     patients whose HIV blood level decreases to less than 500 copies/ml.   "
161580|NCT00001118|"     The purpose of this study is to determine the best dose of T-20, a new anti-HIV drug, to     treat HIV-infected children.      T-20, unlike other anti-HIV medications, lessens the ability of HIV to infect certain cells     (T cells) in the body. Doctors hope to better treat HIV by adding T-20 to anti-HIV drug     combinations that include 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a     nonnucleoside reverse transcriptase inhibitor (NNRTI) and/or a protease inhibitor (PI).   "
161582|NCT00001120|"     The purpose of this study is to find out why cancers develop in HIV-positive patients.      Cancer is a leading cause of death in AIDS patients. Common cancers in HIV-infected patients     include Kaposi's sarcoma (KS) and non-Hodgkin's lymphoma (NHL), a cancer of the immune     system. Risk factors include certain chemicals, viruses, and perhaps even anti-HIV drugs.     Doctors would like to find out which risk factors are most important and how they relate to     cancer in AIDS patients.   "
161583|NCT00001121|"     The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that     occurred in association with known, but discouraged, high-risk behaviors in persons who have     received HIV candidate vaccines or placebo in HIVNET 014. Doctors need to look at how these     patients respond to HIV infection in order to develop new HIV vaccines and other treatments     for HIV and AIDS.      Patients who receive HIV vaccines are sometimes protected from HIV infection. More often,     these patients become HIV-positive but experience a boost in their immune system that helps     their bodies fight HIV. Doctors need to look at how these patients respond to HIV infection     in order to develop new HIV vaccines and other treatments for HIV and AIDS.   "
161584|NCT00001122|"     The purpose of this study is to see if observed therapy can help HIV-positive patients stick     to their anti-HIV medication schedule. Observed therapy means that a nurse will watch     patients take their medications to make sure that they take them correctly.      It is very important that HIV-positive patients take their anti-HIV medications correctly so     they get the best possible benefit from them. Taking the drugs correctly, called adherence,     may keep HIV virus levels in the blood (viral load) low for a longer time. Adherence can also     slow the development of drug resistance, and this is especially important in patients with     early HIV infection who are just beginning treatment. However, anti-HIV medication schedules     are often complicated, and many patients have difficulty remembering to take their drugs at     the correct time. This study will look at the effectiveness of a plan to help patients with     this problem.   "
161585|NCT00001123|"     The purpose is to test the safety and effectiveness of intravenous ribavirin therapy in     persons with suspected and subsequently proven hantavirus infection. The hantavirus is spread     through the air into the lungs when dry rodent feces are moved or disturbed. It is     characterized by fever and bleeding.   "
161586|NCT00001125|"     The purpose of this study is to see if the varicella-zoster virus (VZV) vaccine will be safe     and if it can help prevent shingles in HIV-infected children who have already had chickenpox.      VZV is the virus that causes chickenpox. If this virus is reactivated in the body, it can     also cause shingles. Shingles is common in children with HIV who have had chickenpox,     although it is usually not life-threatening. The VZV vaccine used in this study may be able     to prevent HIV-positive children who have had chickenpox from developing shingles.   "
161587|NCT00001126|"     The purpose of this study is to see what dose of the drug cidofovir is safe to treat     laryngeal papillomatosis (warts in the throat which occur over and over) in children.      Laryngeal papillomatosis is caused by infection with a virus called human papillomavirus     (HPV). At present, there is no approved drug to treat this infection. However, cidofovir is a     drug effective against several viruses. Cidofovir may be able to attack the HPV virus. This     study tests the safety of giving this drug to children.   "
161589|NCT00001128|"     The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12)     to the standard drug combination (paromomycin plus azithromycin) used to treat     cryptosporidiosis in AIDS patients. Doctors would like to find out if the combination of     IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin     alone.      Cryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive     patients as their immune systems weaken. It is caused by a parasite that invades the     intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a     fever. Antibiotics (paromomycin and azithromycin) are usually used to treat     cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12.     IL-12 is a type of protein naturally produced by certain types of cells of the immune system     and is believed to be important for immune function. Doctors hope that IL-12 can help boost     the immune system in fighting cryptosporidiosis.   "
161590|NCT00001129|"     The purpose of this study is to look at different ways to help patients follow their anti-HIV     medication schedules.      It is very important that HIV-positive patients take their anti-HIV medications correctly so     they get the best possible benefit from them. Taking the drugs correctly, called adherence,     may keep HIV virus levels in the blood (viral load) low for a longer time. However, anti-HIV     medication schedules are often complicated, and many patients have difficulty remembering to     take their drugs at the correct time. This study will look at 2 different ways to teach     patients about the importance of taking their medications correctly and to remind them when     to take their medications.   "
161591|NCT00001130|"     The purpose of this study is to identify patients who have early HIV infection. Patients who     have been infected with HIV recently may develop flu-like symptoms within 3 to 8 weeks. Those     who go to the hospital emergency room for these symptoms and who may have been exposed to HIV     recently will be given a questionnaire and the opportunity to be tested for HIV.      Most people develop flu-like symptoms shortly after becoming infected with HIV, and many of     these people go to a hospital emergency room for treatment. However, most doctors do not     think of testing people with flu-like symptoms for HIV. This study will look at a plan to     change this because it is very important to identify patients who have early HIV infection.     Viral load (level of HIV in the blood) is very high during early HIV infection, and it is     easy to spread HIV to others during this period. Patients who learn they are HIV-positive can     stop risky behavior that might spread HIV to other people. Also, patients who find out early     that they are HIV positive are able to begin anti-HIV treatment sooner, slowing the disease.   "
161592|NCT00001131|"     The purpose of this study is to find out if the immune systems of HIV-positive patients can     be improved by treatment with anti-HIV medications plus interleukin-2 (IL-2) in the early     stages of HIV infection.      IL-2 is a protein found naturally in the blood that can help boost the immune system. HIV     spreads throughout the body by invading CD4 cells, which are cells of the immune system that     fight infection. Doctors hope that adding IL-2 to a current anti-HIV drug combination can     help restore the CD4 cell count and the immune functions. This study will look at how the HIV     virus acts during the early stages of HIV infection, how the immune system responds to HIV,     and what impact early treatment with anti-HIV medications has on the course of HIV infection.   "
161593|NCT00001132|"     The purpose of this study is to see if adding 1 drug to an anti-HIV drug combination early in     treatment against HIV can lower the viral load (amount of HIV in the blood) to a level so low     that it cannot be measured (undetectable). The drug that will be added to a treatment is     abacavir (ABC).      Many patients who take 3 anti-HIV drugs together are able to achieve very low viral loads,     for example, viral loads below 50 copies/ml. However, some patients taking only 3 drugs are     not able to achieve a viral load this low. Doctors hope that, by adding the drug ABC to a     current treatment, a viral load below 50 copies/ml can be achieved. Doctors would like to     find out if it is effective to start patients on 3 drugs and then add another drug (treatment     intensification) if the treatment is not working as well as hoped.   "
161594|NCT00001133|"     In this study, the protease inhibitors indinavir (IDV) and ritonavir (RTV) will be studied in     patients who have high levels of virus while taking other protease inhibitors. The purpose of     this study is to see how the body takes in, distributes, and gets rid of IDV and RTV. This     study will also look at any side effects that IDV or RTV causes.      IDV is an effective anti-HIV drug, but it can be difficult for patients to take. For IDV to     work against HIV, it must be taken 3 times a day at a high dose and with a certain diet.     Doctors believe IDV may be easier to take if it is given with RTV. Patients who take IDV and     RTV together may be able to take IDV only twice a day and at a lower dose. This study will     gather information about the safety and side effects of using IDV and RTV together.   "
161595|NCT00001135|"     The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to     HIV-positive pregnant women and their infants can help reduce the chance that a mother will     give HIV to her baby during delivery.      NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to     their infants. NVP is inexpensive and is easily absorbed by the mother and transferred to the     infant. It is thought that even a single dose to the mother and infant may provide enough     protection to the baby during the time of exposure to HIV at birth.   "
161596|NCT00001136|"     The purpose of this study is to see if it is safe to give an HIV vaccine (vCP205) to     volunteers who received an HIV vaccine at least 2 years ago, and to study how the immune     system responds to this vaccine.      Vaccines are given to people to try to resist infection or prevent disease. There are a     number of different HIV vaccines that are currently being tested. The vaccines that seem to     be the most promising are canarypox vaccines, known as ALVAC vaccines; the vaccine tested in     this study is ALVAC-HIV vCP205. This study will look at the safety of the vaccine and how the     immune system responds to it.   "
161597|NCT00001137|"     The purpose of this study is to determine what combinations of anti-HIV drugs work best in     patients treated over several years. The study will also assess the occurrence of side     effects and opportunistic infections in patients with low viral loads compared to those with     higher viral loads.   "
161609|NCT00001153|"     To study the relationship between visual function and ocular (iris, retina/choroidal)     pigmentation in patients with albinism and other hypomelanotic disorders. To identify the     carrier state in relatives of patients with ocular albinism.   "
173835|NCT00116857|"     This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline     on depression and cardiac endpoints after myocardial infarction (MI).   "
161598|NCT00001142|"     Some HIV-infected adults develop lipodystrophy that includes significant changes in body     shape, with fat losses in the face, arms and legs, and fat gain in the trunk. This     lipodystrophy is often accompanied by other disorders of metabolism, such as increased levels     of fat and insulin in the blood.      The majority of these cases have been seen when patients are taking medications called     protease inhibitors. These are anti-retroviral medications designed to treat patients with     HIV. It is unclear if lipodystrophy is a result of having HIV or the medication used to treat     HIV. It has been suggested, but not proven, that lipodystrophy is a direct side effect of     protease inhibitors. In addition, it is unknown if HIV-infected children develop significant     lipodystrophy after taking protease inhibitors.      This study will investigate the prevalence of metabolic disorders and changes in body fat     distribution in children taking protease inhibitor anti-retroviral medications. The results     will be compared to three other groups; (1) children suffering from other non-HIV chronic     infections, (2) HIV-infected children not taking protease inhibitors, and (3) healthy     children.      The study will look at HIV-infected children who have already started taking protease     inhibitors. It will evaluate these children for disorders in metabolism as well as body fat     changes. In addition, the study will follow HIV-infected children who will begin taking     protease inhibitors. The study will follow these children for 18 months to detect the     development of disorders in metabolism and / or body fat changes.   "
161599|NCT00001143|"     Little is known about the development of the ocular, or eye, motor system (the parts of the     brain that control how the eyes move) in children. Recent technological and methodological     advances now enable researchers to investigate the visual system and ocular motor system of     infants, but few findings have been reported. This study hypothesizes that quantitative     analysis of at-risk infants' eye movement systems can detect abnormalities that precede and     predict the onset of strabismus, or cross-eye.      We will collect data on the eye movements of a group of infants born between 36 and 44 weeks     after conception. These infants will be enrolled between 4 and 24 weeks after birth and     followed at 4-week (+/- 5 days) intervals until 28 weeks of age and then once a year until 3     years after birth. The infants will undergo a complete ophthalmic evaluation at each visit     after they enroll. At all visits up to 28 weeks of age, they will also undergo analysis of     eye movements. We also will monitor the development of ocular alignment and check to detect     other visual system abnormalities. The study will provide basic knowledge about the cause of     both normal and abnormal alignment of both eyes in infants in the first 28 weeks of life.   "
161605|NCT00001149|"     This study is designed to evaluate patients with uncontrolled seizures. Seizures can be     associated with and monitored by abnormal electrical activity in the brain.      In this study researchers will use video-electroencephalography (EEG) to monitor patients     with uncontrolled or suspected seizures. EEG works by measuring electrical activity in     different areas of the brain. The video-EEG allows researchers to examine changes in the EEG     along with the clinical features of seizures as they occur.      In addition to monitoring electrical activity of the brain, researchers will take frequent     antiepileptic drug blood levels. These measures will allow researchers to learn more about     how each drug is absorbed and metabolized in the body.      The information collected in the study will be used to place patients into other scientific     studies testing new therapies for epilepsy.   "
162022|NCT00001013|"     To compare the safety and effectiveness of an investigational drug therapy (trimetrexate plus     leucovorin calcium) with that of conventional therapy (sulfamethoxazole-trimethoprim) in the     treatment of moderately severe Pneumocystis carinii pneumonia (PCP) in patients who have     AIDS, are HIV positive, or are at high risk for HIV infection.   "
161600|NCT00001144|"     This study will investigate the safety and effectiveness of a new stem cell transplant     procedure for treating chronic myelogenous leukemia (CML).      Transplantation of donated stem cells (cells produced by the bone marrow that mature into the     different blood components-white cells, red cells and platelets) is a very effective     treatment for CML. However, despite its success in a large number of patients, there is still     a significant risk of death from the procedure. In addition, it results in sterility and     leaves patients at increased risk for other cancers and for eye cataracts. These     complications result from the intensive chemotherapy and radiation patients receive before     the transplant to rid the body of cancer cells. In this study, radiation will not be used and     chemotherapy drugs will be given in lower doses to try to reduce the dangers of the     procedure.      Patients with CML will be tested for matching with a donor (family member) and will undergo a     medical history, physical examination and several tests (e.g., breathing tests, X-rays, and     others) to determine eligibility for the study. Participants will then undergo apheresis to     collect lymphocytes (white blood cells important in the immune system). In apheresis, whole     blood is drawn through a needle in the arm, similar to donating a unit of blood. The required     component-in this case, lymphocytes-are separated and removed, and the rest of the blood is     returned through a needle in the other arm.      Each day starting five days before the transplant, the donor will be given an injection of     G-CSF, a drug that releases stem cells from the bone marrow into the blood stream. The cells     will be collected after the fifth injection and again after a sixth injection the following     day. Meanwhile, patients will be given cyclophosphamide and fludarabine, and perhaps     anti-thymocyte globulin, to prevent rejection of the donated cells.      On the day of the transplant, patients will be given cyclosporin to prevent     graft-versus-host-disease, a disease in which the donor cells react against the patient's     cells. They may also be given lymphocytes after the transplant to boost the immune system and     destroy leukemia cells. After 30, 60 and 100 days, bone marrow cells and circulating     lymphocytes will be checked to see how many are of donor cell origin. If less than 100     percent are of donor origin, more lymphocytes will be transfused. Patients will have physical     examinations and blood tests at least weekly for 3 months and then periodically for 5 years.   "
161610|NCT00001154|"     Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the     blood. This study is designed to improve understanding of normal, as well as abnormal,     lipoprotein metabolism and the role it plays in the development of hardening of the arteries     (atherosclerosis).      Patients participating in this study will receive injections of lipoproteins or     apolipoproteins (the protein component of lipoproteins) that have been isolated and purified.     These lipoproteins will be labeled with small amounts of radioactive material and sterilized     before they are injected into the patient.      Patients participating in the study will be required to have blood samples taken, and provide     urine samples throughout the course of the study. In addition, patient will be required to     follow a specially formulated diet. Patients will be weighed throughout the course of the     study.   "
161611|NCT00001155|"     The purpose of this protocol is to continue to treat patients with Wegener's granulomatosis     who have already entered the study, and to treat new patients. The investigators will attempt     to correlate the clinical response with specific immunosuppressive effects of drug     administration. The investigators are accumulating data on the optimal duration and side     effects of therapy.   "
162182|NCT00002052|"     To compare the effectiveness of standard treatment with parenteral ampicillin and oral     amoxicillin compared to initial daily therapy with ceftriaxone followed by 3 times weekly     suppressive treatment for salmonella infections in AIDS patients.   "
161601|NCT00001145|"     The primary goal of this Phase I/II study is to assess the immune response and safety of     recombinant human CD40 ligand (rhuCD40L) in patients with X-linked hyper IgM syndrome (XHIM).     XHIM is a rare genetic disease caused by mutations in the gene encoding CD40 ligand.     Individuals with this syndrome fail to make gamma immune globulin, frequently suffer from     opportunistic infections, and are at an increased risk of developing cancer. Despite     treatment with gamma globulin replacement therapy, the expected survival of patients with     XHIM is less than 20 percent by the age of 25.      In a mouse model of this syndrome, treatment with man-made CD40 ligand protein protected the     mouse from opportunistic infections, restored the mouse's ability to make gamma globulin, and     improved survival. We want to determine if a similar approach can work in humans with XHIM.     The study will be conducted at the Clinical Center of the National Institutes of Health in     Bethesda, Maryland.      For most patients, rhuCD40L will be administered by injection under the skin over a period of     six months and follow-up exams are required at 2-month intervals for an additional 6 months.     During the study, patients will be maintained on intravenous gamma globulin, antibiotics to     protect against opportunistic infection, and, if needed, growth factors to control     neutropenia. The immune response to rhuCD40Lwill be measured by routine methods such as     measuring a patient's ability to synthesize gamma globulin when challenged with immunizations     to keyhole limpet hemocyanin (KLH) and Bacteriophage Phi-X 174 (Phi-X 174). Our long-term     goal is to define a therapeutic regimen that will provide effective immunological     reconstitution to patients with XHIM and improve their life expectancy.   "
161602|NCT00001146|"     This study will examine the effectiveness of omega-3 fatty acids, compounds found in plants     and fish, in treating bipolar disorder.      Some studies have indicated that omega-3 fatty acids may be effective in treating mood     disorders.      For example, one investigator has shown a correlation between the prevalence of major     depression and the amount of fish consumed per capita worldwide. Others have found decreased     amounts of EPA (one of the active ingredients in omega-3 fatty acids) in the red blood cells     of patients with major depression. And a recent small study of patients with bipolar illness     indicated that omega-3 fatty acids prevented relapses, especially of depression, in patients.      Patients with bipolar disorder who are not benefiting satisfactorily on their current     medications are eligible to participate in this study. Candidates will be screened with a     psychiatric evaluation, routine blood tests, a urine test and other tests needed to monitor     medications. Participants will be randomly assigned to one of two groups: one group will     receive 6 grams of omega-3 fatty acid every day for 16 weeks; the second will receive a     placebo (inactive capsule). In addition, patients in both groups will continue to take their     previous medications. Every 2 weeks, all patients will have their vital signs checked and be     evaluated for side effects and mood changes. At the end of the 16-week study period, all     patients will be given the opportunity to continue in the study for another 8 months and     receive active drug (omega-3 fatty acid). Patients who continue will be evaluated once a     month and will have blood drawn on the last visit for routine tests.   "
161603|NCT00001147|"     This study involves sampling blood from both normal volunteers and patients with diseases     known or suspected to involve body chemicals called catecholamines. The blood will be used to     establish normal values for plasma levels of catecholamines and related neurochemicals; to     test for abnormal neurochemical patterns in patients; and to establish a bank of DNA from     normal volunteers and from patients to be used in future studies about possible alterations     of catecholamine-related genes.      Study participants will report to NIH after fasting overnight except for water or noncaloric,     noncaffeinated beverages. They must not have taken Tylenol for at least 5 days. Blood will     then be drawn. DNA will be extracted and stored in the freezer for future studies.   "
161604|NCT00001148|"     Glioblastomas, the most frequent malignant brain tumor in adults, are widespread in the     brain, despite their discrete appearance on computed tomography (CT) or magnetic resonance     imaging (MRI). While this tumor tends to spread widely in the brain, unlike other tumors of     the body, it rarely metastasizes, or spreads, to other organs. Approximately 10 percent of     patients with glioblastoma develop metastatic disease after radiation or brain surgery. In     the absence of radiation or brain surgery, few patients have developed disease spread outside     the brain.      During surgery to remove tumors of other organs of the body, such as the lung, prostate,     kidney, or ovary, cells from these tumors are routinely found in the bloodstream. These cells     are believed to be the reason for the spread of these tumors. In the case of malignant brain     tumors, this process of glioma (tumor) cells shedding into circulation has not yet been     investigated.      This study will determine whether glioma cells can be detected in the bloodstream of patients     undergoing surgery. If glioma cells are absent, it may mean they are unable to penetrate the     blood-brain barrier. If they are present, they presumably can penetrate into blood vessels     but they may be recognized and eliminated by the immune system, or they may escape detection     yet not be able to take hold in the new microenvironment. The results of the study will add     to the knowledge of the biology of these highly malignant tumors.      Study participants will be admitted to the hospital for 8 to 10 days. They will undergo a     complete physical and neurological exam and blood and urine tests. An electrocardiogram will     be performed, and x-rays may be taken. On the morning of surgery, the patient will receive     sedation intravenously. A tiny plastic tube called a catheter will be introduced into a vein     in the groin through needles. The catheter will be passed through to the jugular bulb, right     above the jugular vein, on the same side as the tumor. The patient will then be taken to the     operating room for surgery. During surgery, not more than one quarter of a unit of blood will     be removed through the catheter. The catheter will be removed before the patient enters the     intensive care unit. Another MRI will be taken after surgery.      The study will enroll participants for 2 years. Patients will be followed at 3 months and 6     months after the surgery to make sure the postoperative period is uneventful.   "
161606|NCT00001150|"     The use of a suction blister apparatus has facilitated study of the immunologic capacity of     human epidermal cells. We have been able to prepare purified populations of these cells after     blister formation. Specifically, using the blister tops, we are able to enrich for epidermal     Langerhans cells which are very potent stimulators in antigen presenting assays. Thus, this     normal volunteer study provides an important source of fresh epidermal tissue from which we     can study normal epidermal Langerhans cell function. In addition, we have recently used     blister roofs in important experimental models of HIV-1 transmission. There is no other     method available for assessing the biologic function of freshly isolated Langerhans cells     without altering their milieu. It is a very safe and effective way to obtain human epidermal     samples.   "
161607|NCT00001151|"     Vitamin D in the diet undergoes changes in the liver and kidneys to several forms. Patients     suffering from disorders with Vitamin D resistance are unable to absorb calcium from food.     Patients diagnosed with these disorders will be evaluated and treated with high doses of     another form of Vitamin D (1,25-dihydroxyvitamin D3). Patients will be monitored and observed     throughout the study to avoid experiencing side effects from the medication.   "
161608|NCT00001152|"     To compare patients having PDS without and with OH or GL by documenting and following the     clinical features and course of their disease and evaluating the patient's performance on a     variety of diagnostic tests.   "
161612|NCT00001156|"     Multiple sclerosis (MS) is a disease of the nervous system. The exact cause of MS is unknown,     but it is believed to be an autoimmune condition. Autoimmune conditions are diseases that     cause the body's immune system and natural defenses to attack healthy cells. In the case of     MS, the immune system begins attacking myelin, the cells that make up the sheath covering     nerves. Without myelin, nerves are unable to transmit signals effectively and symptoms occur.      This study is directed toward a better understanding of the cause of Multiple Sclerosis (MS).     Researchers will evaluate patients with a tentative diagnosis of MS or other neurological     diseases possibly caused by a immunological reaction. Patients will undergo a series of three     MRIs, taken once a month for three months and submit blood samples for immunological studies.   "
161613|NCT00001158|"     The goal of the protocol is to define the normal humoral and cellular immune responses to     antigens in volunteers and to define abnormalities of these immune responses in patients with     immunodeficiency diseases or cancer. In vitro assays and in vivo skin tests and immunization     with antigens will be utilized.   "
161614|NCT00001159|"     Participants in this study will be patients diagnosed with or suspected to have a thyroid     function disorder. These conditions may include: hypothyroidism, hyperthyroidism, thyroid     hormone resistance, Graves' Dermopathy, and thyroid-stimulating hormone (TSH) secreting     pituitary adenomas.      The main purpose of this study is to further understand the natural history, clinical     presentation, and genetics of thyroid function disorders. Many of the tests performed are in     the context of standard medical care that is offered to all patients with thyroid function     disorders. In addition, blood and tissue samples may be taken for research and genetic     studies....   "
161616|NCT00001161|"     This study will investigate congenital or developmental eye abnormalities that affect the     iris, cornea and lens, and are usually accompanied by elevated pressure within the eye. These     disorders can cause vision loss, and the increased eye pressure can lead to glaucoma, a     condition that may also cause loss of eyesight.      Patients with eye anterior chamber eye disease, such as Axenfeld's syndrome, Rieger's     anomaly, Peter's anomaly, iridocorneal endothelial syndrome, megalocornea, ocular     hypertension, and others, are eligible for this study. Participants will have a medical     examination, family history, and comprehensive eye examination. Tests and procedures may     include photographs of the cornea, iris, and the structure through which fluid that normally     circulates behind the cornea drains out of the eye. Some patients may undergo indentation     tonography to measure how easily this fluid drains. In this procedure, the patient lies on an     examination table and both eyes are numbed with eye drops. A small instrument (tonometer) is     placed on the surface of one eye, and with the other eye, the patient looks at an overhead     light. Other tests may include photographs of the back of the eye and ultrasound imaging of     the structures of the eye. A blood sample may be drawn to study the genetic disorder     responsible for the disease. Patients will have follow-up examinations every 6 months for the     duration of the study.      Medical or surgical therapy will be recommended, as appropriate, for patients who develop     elevated eye pressure or vision loss.   "
161617|NCT00001162|"     This protocol offers diagnosis and standard medical treatment for various parasitic     gastrointestinal infections. Gastrointestinal parasites are either worms (helminths) or     one-celled animals called protozoans which live in the human intestines. Often, parasitic     infections do not cause illness. In these cases, drug treatment is not indicated, because     treatment can have adverse side effects. Patients will be examined for their immune     responses, correlation between the number of parasites and disease, and other studies.      Individuals with known or suspected parasitic diseases of the gastrointestinal tract,     including amebiasis, giardiasis, hookworm, strongyloidiasis, trichuriasis, pinworm, tapeworm,     trichinosis, clonorchis, opisthorchis, coccidiosis, paragonimiasis, and echinococcus may be     eligible for this study.      Patient evaluations may include blood and urine tests, stool examination, X-rays, ultrasound     studies and, uncommonly, duodenal aspiration for examination of fluid from the duodenum     (first part of the small intestine). Other tests may be required, depending on the parasite     and disease. Direct examination of the tissues of the intestines may be required to rule out     certain infections.      Research procedures include collection of stool, blood and duodenal fluid when the diagnosis     has been established and these procedures are not required for medical care. Patients with     strongyloidiasis may also be given a diagnostic skin test similar to skin tests for     tuberculosis and allergies. Research procedures on children will be limited to collection of     stool, urine and blood. No more than 7 milliliters (1 1/2 teaspoons) per kilogram (2.2     pounds) body weight of blood will be collected in children over a 6-week period. In adults no     more than 30 tablespoons of blood will be collected in a 6-week period.      Parasites may fail to respond to treatment. In these cases, it may be necessary to grow the     parasite in the laboratory in order to test treatments in the test tube. Patients who do not     respond to standard medications and dosing may need different doses of drugs or drugs or     combinations of drugs used in the United States for other medical problems. If these     medications or doses are used, patients will be informed of their possible side effects.   "
161618|NCT00001163|"     This is a clinical, epidemiologic, genetic, and laboratory study of individuals and families     at high risk of cancer and selected tumors to investigate the genetic susceptibility and     environmental exposures which may alter cancer risk. Families with multiple members who have     an unusual pattern or number of cancers or tumors are evaluated clinically. This evaluation     is specific for the type of cancer or tumor predominant in the family in order to determine     the affection status of each individual for genetic epidemiologic studies. Genetic and     environmental risk factor information specific for the tumor type is obtained.      Individuals with, or at high risk of, cancer because of their personal, familial, or     environmental histories are identified by healthcare worker referral or by personal inquiry.     Relevant etiologic risk factor information is documented through review of pathology     specimens and medical, vital, and genealogical records. Selected individuals and family     members are asked to complete questionnaires and to undergo clinical evaluations specific for     the tumor of interest. They are also asked to donate biologic specimens to be used in the     search for cancer etiology and mechanisms of carcinogenesis. No therapy beyond counseling and     education for cancer prevention, risk reduction, and early detection will be given.      Genetic testing for tumor susceptibility gene(s) mutations and risk notification will be     offered to study participants for whom a specific mutation predictive of disease has been     identified in his/her family. This testing will only be offered when reasonable individual     cancer risk estimates can be delivered, and only to those participants who choose to know     their individual genetic status after appropriate education and counseling. The testing will     be conducted exclusively in Clinical Laboratory Improvement Amendments (CLIA)-licensed     laboratories. Genetic testing and risk notification are entirely optional and do not affect     participation in other aspects of the protocol. A separate consent procedure and consent form     will be used for genetic testing and risk notification related to these specific genes.      Once enrolled, study participants are monitored prospectively for the development of outcomes     of interest, typically by means of periodic mail or telephone contact. In selected instances,     subjects may return to the Clinical Center periodically for study-specific follow-up     examinations. Although we do not offer specific anti-cancer therapy as part of this protocol,     we provide assistance to insure that study participants who require treatment for     tumor-related problems that develop during the course of the study are referred to     appropriate healthcare providers. We remain available to study participants and their     healthcare providers for advice and consultation related to the management of familial     cancer/tumor predisposition.   "
161619|NCT00001164|"     It is proposed that patients with skin disease due to presumed immunologic, genetic or     viral-induced abnormalities, patients with neurological degenerations, and normal controls be     evaluated with various in vitro studies of immunologic, genetic, and virologic function. This     is to include studies of peripheral blood (cells and serum) as well as studies of skin     obtained with a biopsy instrument. In addition, studies of gastrointestinal function will be     performed where appropriate.   "
162183|NCT00002053|"     To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of     aerosol pentamidine versus placebo when used as a prophylactic agent in patients who have     recovered from their first episode of AIDS-associated Pneumocystis carinii pneumonia (PCP).   "
161620|NCT00001165|"     Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal     tract, higher than normal levels of gastric acid, and tumors of the pancreas known as     non-beta islet cell tumors.      Prior to the use of drugs to cure the ulcers, patients typically died due to severe ulcers.     Because of such effective drugs to treat the ulcers it is more common to see patients dying     due to the pancreatic tumors.      The study will observe patients suffering from Zollinger-Ellison Syndrome and non-beta islet     cell tumors and determine the effectiveness of combined chemotherapy with streptozotocin,     5-fluorouracil, and doxorubicin.   "
161621|NCT00001166|"     Gyrate atrophy is a rare hereditary disease of the eye's retina (the layer of light-sensitive     tissue that lines the inside of the eyeball) and choroid (a vascular layer of tissue behind     the retina). Degeneration of these structures causes near-sightedness, cataracts and     progressive loss of vision. This study will examine eye function and chemical and molecular     abnormalities in patients with gyrate atrophy to try to better understand, diagnose, and     treat the condition. Patients with other degenerative diseases of the choroid and retina,     such as retinitis pigmentosa, choroideremia, and others, will also be studied for comparison.     Family members of patients will be studied, when possible, to try to identify the genetic     basis of the disease and gain information that will aid in genetic counseling.      Study participants will undergo a physical examination and eye examination, including tests     of color vision, field of vision, and ability to see in the dark. An electroretinogram and     electrooculogram will measure visual cell function. Photographs of the retina will be taken.     Blood will be drawn for biochemical study and gene research. Family members who agree to     participate in the study will undergo the same eye tests and will also have blood drawn for     genetic studies. Patients with gyrate atrophy will also be asked to undergo a small skin     biopsy for biochemical and genetic study. They will provide a family history in order to draw     a family tree showing how the disease is distributed among family members.      Patients with gyrate atrophy may also participate in studies of the effect of vitamin B6 and     diet on blood levels of the amino acid ornithine, which is elevated in patients with gyrate     atrophy. Participants will take 500 mg of vitamin B6 by mouth every day for 3 to 6 months. If     this study confirms a reduction of ornithine levels, then long-term studies of the vitamin as     a possible treatment for the disease may be started.      After the vitamin B6 study, patients will start a nearly protein-free diet to lower ornithine     blood levels. More than 2,000 calories are carbohydrate and fat. Some special low-protein     foods and limited fruit is included, plus amino acid supplements. Patients who have carefully     adhered to this diet have lowered their ornithine levels and slowed disease progression.     Patients will be hospitalized for the first 1 to 3 weeks for close monitoring with frequent     urine and blood tests. When the blood ornithine level is normalized, a less restricted low     protein diet will be prescribed. Participants will have monthly blood tests and a complete     eye examination every 6 months to 1 year to evaluate disease progression.   "
161622|NCT00001167|"     This study will assess the use of ultrasound-a test that uses sound waves to produce     images-as a diagnostic tool for evaluating speech and swallowing.      The following categories of individuals may be eligible for this study: 1) healthy volunteers     between 20 and 85 years old with normal speech and hearing, 2) patients 6 to 85 years old     with developmental neurological deficits in speech or swallowing, and 3) patients with tumors     of the oral cavity, pharynx or larynx being treated at the Greater Baltimore Medical Center.      Participants will undergo a 30-minute speech and oral motion evaluation, in which they     imitate sounds, words and oral movements while a speech pathologist evaluates their lip,     tongue and palate movements. They may also be asked to drink a small amount of water for     examination of swallowing function.      For the ultrasound examination, a 3/4-inch transducer (device for transmitting and receiving     sound waves) is placed under the participant's chin. While the transducer is in place, the     subject 1) repeats sounds and a series of syllables in several sequences, 2) swallows three     times with and without a small amount of water, and 3) swallows 3 teaspoons of non-fat     pudding. The ultrasound images are recorded on tape for later analysis.   "
161641|NCT00001189|"     Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue     tumors will receive wide local excision and be prospectively randomized as to either receive     or not receive radiation therapy.   "
161623|NCT00001168|"     Lipoproteins are particles that carry fats such as cholesterol and triglycerides through the     blood stream. These particles are involved in causing blood vessel disease that can lead to     conditions like hardening of the arteries (atherosclerosis) or heart attacks (myocardial     infarctions).      This study is designed to look closely at the factors affecting lipoproteins. Researchers     plan to study patients and normal volunteers by measuring lipoprotein levels in the blood.     Patients and volunteers will be placed on a balanced diet during the study. In addition,     researchers plan to measure levels of various hormone and enzymes in the blood. Patients and     volunteers participating in the study may be asked to undergo more specific tests in order to     collect more information about lipoprotein metabolism.      This study may not provide direct benefits to patients and volunteers participating in it.     However, information gathered from this study may help researchers develop better skills and     techniques to diagnose and treat patients with diseases of lipoprotein metabolism.   "
161624|NCT00001169|"     Mechanisms of host immune response to intracellular protozoa will be investigated in patients     with naturally acquired infection employing a variety of in-vitro techniques. Both     non-specific and antigen-specific humoral and cellular immune responses will be assessed.     Parasites will be isolated from patients, cultivated in-vitro, and characterized. Responses     to chemotherapy will be assessed parasitologically, immunologically and clinically.   "
161625|NCT00001170|"     This research study is the continuation of a study started more than 20 years ago. The study     was designed to explore the effect that depressed parents have on their children and to     better understand the factors that contribute to depression development and maintenance.      The study will continue to investigate if children have certain characteristics in early and     middle childhood that predict the later development of psychological disorders.      In addition, the study will continue looking at the processes responsible for the development     of children of parents with and without affective (mood) disorders.   "
161626|NCT00001171|"     Presently, patients with primary malignant brain tumors have a life expectancy of 15 weeks     following surgery unless they receive additional types of therapy (chemotherapy,     radiotherapy, and/or immunotherapy). Patients that receive additional therapy can increase     life expectancy to 50 weeks.      The statistics on the life expectancy and survival have increased efforts among researchers     to develop new treatments for primary malignant brain tumors.      This research project involves the growth and study of human brain tumor cells outside the     body in the laboratory as part of an attempt to better understand these tumors and to develop     more effective treatments for them.   "
161765|NCT00000754|"     To determine the safety and efficacy of two doses of interferon alfa-2a ( IFN alfa-2a ) in     combination with zidovudine ( AZT )/zalcitabine ( ddC ) versus AZT/ddC only in patients with     HIV infection and CD4 count < 400 cells/mm3.      AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN     alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites     of viral replication may improve HIV inhibition and produce more effective and sustained     anti-HIV effects.   "
161627|NCT00001172|"     This study is designed to understand how we see visual patterns and how these patterns lead     to eye movements.      Normal volunteers participating in this study face a screen on which spots or patterns of     light are projected. They are asked to respond to the patterns by voice, eye movements or     hand movements. Eye and lid movements are recorded in one of the following ways:        1. Electro-oculogram < small disc electrodes taped to the skin near each eye measure the          eye movements as the eyes change position.        2. Infrared detector < an infrared beam is reflected off the eye and picked up by detectors          that record the eye movements.        3. Contact lens ring < a smooth plastic ring is placed on the white of the eye surrounding          the cornea and eye position is measured using a magnetic coil.      Study sessions last less than four hours.   "
161628|NCT00001173|"     One of the major interests of this laboratory is the characterization of the cellular     subpopulations involved in the triggering and immunoregulation of B lymphocytes to produce     antibodies. We are assessing the responses of individuals to produce antibodies against newly     encountered antigens such as keyhole limpet hemocyanin (KLH) (approved project number     77-I-0130) and propose to assess the amnestic responses to the previously encountered     antigen, tetanus toxoid. The purpose of this protocol is to add this recall antigen to our     repertoire of antigens used to evaluate the immune response in man.      Booster immunization with tetanus/diphtheria toxoid has now been used for several years by a     number of clinical immunology laboratories throughout the country to assess B cell related     immunologic profiles in patients and control normal subjects. We have recently developed a     sensitive ELISA assay for IgM and IgG in vitro specific antibody responses against tetanus     toxoid. This will allow us to carefully and precisely monitor the evolution and     immunoregulation of the human B cell responses to this recall antigen. This is of particular     importance and relevance to us in our ongoing studies of a number of diseases characterized     by abnormalities of immunologic reactivity, including those treated with various regimens of     immunosuppressive agents.   "
161629|NCT00001174|"     This study looks to identify genes that may affect a person's chances of developing bipolar     disorder (BP) and related conditions.   "
161630|NCT00001176|"     Some patients with high blood pressure can experience an increase of blood pressure by 10     percent or more by taking in salt. These patients are referred to as having salt-sensitive     (SS) hypertension.      Previous studies conducted on patients with salt sensitive hypertension suggest that their     portion of the nervous system responsible for maintaining normal blood pressure (autonomic     nervous system) may respond differently to salt than patients with non-salt sensitive (NSS)     hypertension.      This study is designed to examine the response of the nervous system to high doses of salt in     patients with salt-sensitive hypertension and patients with non-salt sensitive hypertension.   "
161631|NCT00001177|"     The purpose of this study is to identify and describe the symptoms of premenstrual syndrome     (PMS).      Women who experience PMS symptoms will complete clinical interviews, self-rating scales, and     evaluations of mood and endocrine function. A subgroup of women with severe PMS (Premenstrual     Dysphoric Disorder or PMDD) will be offered additional research studies that focus on: 1)     identifying the endocrine changes that may be responsible for changes in mood and behavior     during the premenstrual period, 2) evaluating treatments for PMS symptoms, and/or 3)     identifying genetic factors in women with and without PMS. Women with recurrent brief     depression will also be recruited to serve as a comparison group.   "
161632|NCT00001178|"     The Cognitive Neuroscience Section of the National Institute of Neurological Disorders and     Stroke proposes to continue its cross-sectional and longitudinal studies of cerebral     metabolism in frontal lobe dementias and atypical basal ganglia disorders. These studies     include repeated assessments of neuropsychological and brain anatomical and metabolic     function in subjects with these important and possibly related brain disorders.   "
161633|NCT00001180|"     Corticotropin Releasing Hormone (CRH) is a hypothalamic hormone made up of 41 amino acids.     Amino acids are proteins that when combined make up different substances, like hormones. The     order of amino acids in CRH, has been determined, meaning that the hormone can now be     synthetically reproduced in a laboratory setting.      When CRH is released from the hypothalamus it stimulates the pituitary gland to secrete     another hormone, ACTH. ACTH then causes the adrenal glands to make a third hormone, cortisol.     This process is known as the hypothalamic-pituitary-adrenal axis. Problems can occur in any     of the steps of this process and result in a variety of diseases (Cushing's Syndrome and     adrenal insufficiency).      Researchers hope that CRH created in a laboratory setting, ovine CRH (oCRH) can be used to     help diagnose and treat conditions of the HPA axis. This study will test the relationship for     single doses of oCRH in normal volunteers and patients with disorders of the HPA axis. The     oCRH will be injected into the patients vein as a single injection or slowly through an IV     line over 24 hours. The participants will have blood tests taken to measure hormone levels     before, during, and after receiving the oCRH.   "
161634|NCT00001181|"     The normal changes of puberty, such as breast enlargement, pubic hair and menstrual periods,     usually begin between the ages of 9 and 15 in response to hormones produced in the body. Some     children's bodies produce these hormones before the normal age and start puberty too early.     This condition is known as precocious puberty.      The hormones responsible for the onset of puberty come from the pituitary gland and the     ovaries. The hormones from the pituitary gland act on the ovaries to produce different     hormones that cause the breasts to grow, pubic hair to develop, and menstruation.      Many children with precocious puberty can be treated with a medication known as lutenizing     hormone-releasing hormone analog (Lupron, Histerelin, Deslorelin). This drug is made in a     laboratory and is designed to act like the natural hormone LHRH, which is made in the     pituitary gland. The drug causes the pituitary gland to decrease the amount of hormones it is     releasing and thereby decrease the amount of hormones released by the ovaries. However, some     girls already have low levels of pituitary hormones and yet their ovaries still produce     hormones. Researchers do not believe that LHRH analog therapy will work for these children.      Testolactone is a drug that acts directly on the ovary. It works by preventing the last step     of estrogen production in the ovary. The goal of this treatment is to stop estrogen     production and delay the onset of puberty until the normal age.      Researchers will give patients with LHRHa resistant precocious puberty Testolactone for six     months. If the initial treatment is successful and patients do not experience very bad side     effects, they will continue to receive the medication until puberty is desired. Throughout     the therapy patients will receive frequent monitoring of their general state of health,     hormone levels, and medication levels.   "
161766|NCT00000755|"     To examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen.     To determine the effect of antiretroviral therapy on vaccine responsiveness.      Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been     hypothesized that HIV-specific immune responses are responsible for the period of relative     quiescence of viral replication. Recent studies suggest that these immune functions can be     augmented by vaccination with HIV-derived antigens.   "
161635|NCT00001182|"     This study offers evaluation and treatment of patients with unusual diagnostic or treatment     considerations. It is not designed to test new treatments; rather, patients will receive     current standard of care treatments. The purposes of the study are: 1) to allow NIDCR staff     an opportunity to maintain and improve their clinical skills; and 2) to evaluate referred     patients for research potential. (Participants in this protocol will not be required to join     a research study; the decision will be voluntary.)      Patients in need of dental/oral diagnosis and therapy of interest to NIDCR staff dentists may     be eligible for this protocol. Participants will have a comprehensive dental examination and     may receive part or all of their treatment at the NIDCR clinic. Diagnostic procedures,     materials and treatments used in this study are limited to those widely accepted in dentistry     and are non-experimental in nature.   "
161636|NCT00001183|"     Chronic lung diseases are disorders associated with abnormalities in any of the structures     involved in the process of breathing and bringing oxygen into the lungs and blood. This     includes abnormalities in the airways, lungs, blood vessels in and around the lungs, and the     tissue covering the lungs (pleura).      The purpose of this research study is to evaluate patients referred to the Cardiovascular and     Pulmonary Branch of the National Heart, Lung, and Blood Institute (NHLBI) in order to;        1. <TAB>Develop a better understanding of the causes and disease processes involved in          disorders of the lungs        2. <TAB>Identify patients eligible to participate in other P-CCMB research studies   "
161637|NCT00001184|"     This study will investigate in patients with Crohn s disease and ulcerative colitis how the     body s immune system controls inflammation in the gastrointestinal tract (stomach and     intestines) specifically, how lymphocytes (a type of white blood cell) function in     inflammatory responses. This protocol does not involve any experimental treatments.      Patients between the ages of 8 and 75 years of age with Crohn s disease or ulcerative colitis     or symptoms of inflammatory bowel disease may be eligible for this study. Screening tests may     include the following: medical history and physical examination, routine blood tests,     examination of stool specimens, X-rays such as barium enema or upper GI series,     proctosigmoidoscopy, colonoscopy, gastroduodenoscopy, and small bowel biopsy.      Participants will receive medical treatment according to the best generally accepted measures     for treating Crohn s disease or ulcerative colitis. This may include anti-inflammatory drugs,     immunosuppressive drugs, and antibiotics to treat infections. A surgical consultation may be     recommended for patients whose disease does not respond to medical treatment. If surgery to     remove intestinal tissue is recommended, a qualified gastrointestinal surgeon will perform     the procedure.      In addition, participants may undergo the following procedures:        -  Blood drawing No more than 450 milliliters (30 tablespoons, or 15 ounces) of blood will          be taken from adults over a 6-week period. A maximum of 7 ml (1/2 tablespoon) of blood          per kilogram (2.2. pounds) of body weight will be obtained from children within the same          time period, with no more than 3 ml/kg taken at any one time.        -  Leukapheresis This procedure is done to collect large quantities of white blood cells.          Whole blood is collected through a needle in an arm vein, similar to donating blood. The          blood is circulated through a machine that separates it into its components, and the          white cells are removed. The rest of the blood is returned to the body, either through          the same needle or through another needle in the other arm.        -  Intestinal biopsies Intestinal tissue will be obtained during colonoscopy with          intestinal biopsy in patients who require this procedure as part of their standard          medical care. Patients are given a sedative to reduce anxiety, but are conscious during          the procedure. A flexible tube is inserted into the rectum and large intestine, allowing          the physician to see the intestinal mucosa. At various places, small pieces of tissue          are plucked out.   "
161638|NCT00001185|"     Polio or poliomyelitis is the disease caused by the poliovirus. The virus attacks cells in     the spinal cord and causes symptoms of fever, sore throat, headache, vomiting, and stiffness     of the neck. Patients with polio can have long-term weakness of muscles as a result of the     damaged cells in the spinal cord. Occasionally, patients that recover from the disease can     experience a relapse of muscle weakness. This can occur as long as 25-35 years after first     having polio. The condition is called post-polio syndrome.      Not all nerve cells in the spinal cord are damaged by the poliovirus. Some nerve cells remain     healthy and take over the work of the damaged cells. Researchers believe that the post-polio     syndrome may be caused by failure of these overworked nerve cells. However, what causes     these overworked nerve cells to disintegrate is unknown.      The purpose of this study is to apply specific scientific tests to answer important questions     about the causes and development of the post-polio syndrome. Researchers will investigate     possible genetic, immunologic, and physiologic causes of the post-polio syndrome. The study     itself will not provide therapy for patients with the condition, but may lead to the     development of therapies in the future.   "
161639|NCT00001186|"     Background:        -  Cancer has an enormous impact on the psychological and social well-being of the family          unit. The life-threatening connotations of cancer single out the ill child from his          peer/family group as one who is different, and often unable to maintain a normal          lifestyle. Physical sequelae of cancer and its treatment accentuate the differences          between these children and their normal peers/siblings.        -  It is important that children with cancer be prepared to function outside of protected          situations and begin to develop skills of separation and independence. For healthy          children, some of these latter skills are acquired by a camping experience. Such an          experience for the patient with cancer is frequently precluded by their dependence on          medical facilities and the physical limitations of their activities.        -  The goal of this study will be to assess the short and long term benefits of the          normalized camping experience, provided in conjunction with Special Love, Inc., on the          patients and staff. In particular, we will seek to determine whether such a          comprehensive experience is capable of influencing the attitudes and life experiences of          patients and staff in a positive manner.      Objectives:        -  To evaluate the impact of an enriched normalized camping experience on the quality of          life of the pediatric cancer patient. In particular, attempts will be made to measure          the manner in which this experience influences the child's sense of well-being and          self-esteem as well as his or her relationship with parents, family, and peers.        -  To provide the atmosphere of a camping experience to the professional and volunteer care          givers with the hope that they will utilize this experience in improving the quality of          their interrelations with the patient population.      Eligibility:        -  Children 7-17 years of age who are currently being treated for cancer or are up to 3          years post therapy OR Young adults with cancer (YACers) who are acting as counselors at          Camp Fantastic        -  All children/young adults will be selected for camp after careful screening by a          multidisciplinary committee consisting of medical and program directors.        -  At the discretion of the multidisciplinary committee consisting of medical and program          directors, special exceptions may be made for children with extenuating circumstances.      Design:        -  Assessment of benefit may include interviews with children and families before, during          and following camp. Observational data on the child's performance at camp will be noted.        -  Medical and nursing personnel will consist of staff from the Pediatric Branch at the          NCI, other units within the NIH, and participating institutions.        -  Special Love members, the Program Director at the 4-H Center camp (site of the camp) and          Pediatric Branch staff at the NCI will coordinate the camp program, taking into account          the medical needs of each camper.        -  Every attempt will be made to provide a full agenda of age appropriate activities for          the patients.        -  The length of the camping experience for children with cancer will be for 7 days          beginning on a Sunday and extending through the following Saturday morning. Patients          will be transported to the camp from the NIH Clinical Center and the Virginia hospitals          by bus.   "
161640|NCT00001188|"     Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to     either receive or not receive radiation therapy following surgery for the removal of the     local tumor. All patients in this protocol will receive adjuvant chemotherapy.   "
161642|NCT00001190|"     Children with extreme short stature (height) and their families often experience significant     psychological stress related to concerns about adult height. In addition, short stature often     results in life-long emotional, social, and physical obstacles to the affected person.      Normal growth occurs in two phases. The first phase, known as childhood growth, occurs below     the age of 10. The second phase of growth, teen-age or adolescent growth, begins between the     ages of 10 and 15. In addition, puberty marks the time when the bone's growth plates     (epiphysis) begin to close, initiating the completion of linear growth (height).      Some children suffer from a condition called precocious puberty, meaning that puberty begins     at a younger age than normal. The development of medications known as synthetic LHRH analogs     have provided a method to delay puberty and treat these patients.      LHRHa (deslorelin) is a hormone created to act like naturally occurring LHRH. It been used in     patient's diagnosed with precocious (early onset) puberty. The drugs were able to regress     patient's clinical signs of puberty, decrease the levels of adult sex hormones produced, and     slow the rate of bone aging.   "
161660|NCT00001211|"     The amendment to Clinical Protocol 86-D-0015, clinical study of Oral Endosseous Titanium     Implants in Edentulous subjects, and patients with Ectodermal Dysplasia is to allow the     Investigators to determine: (1) If placement of Endosseous Titanium Implants in     pre-adolescent patients (age 7 to 10) will influence the growth and development of the     craniomandibular complex. (2) The final position of the implant, the ability to fabricate     prosthesis. (3) Body image, diet and perceived ease of chewing selected foods.      Selection of patients for participation in the study will be based on the number of     congenitally missing teeth associated with Ectodermal Dysplasia. At least 16 permanent teeth     must be congenitally missing. A total of 30 patients will be included.      A consent to participate in this study will be obtained from each patient:      18 & older - consent signed by patient      13-17 years - consent signed by parent, assent signed by patient      7-10 years - consent by parent, assent signed by child if capable of understanding or note on     chart describing procedure used to obtain the child's assent to the study   "
161643|NCT00001191|"     Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal     tract, higher than normal levels of gastric acid, and tumors of the pancreas known as     non-beta islet cell tumors. Patients with Zollinger-Ellison Syndrome require continuous     control of their gastric acid secretion. If gastric acid levels are permitted to rise higher     than normal, patients may develop severe ulcers and other complications.      This study will attempt to determine the effectiveness of Omeprazole (Prilosec) in the     treatment of patients with Zollinger-Ellison Syndrome. Omeprazole is a drug that functions to     decrease the amount of gastric acid secreted.      Patients for this study will be selected based on a previous diagnosis of Zollinger-Ellison     Syndrome and/or idiopathic (unknown cause) high levels of gastric acid secretion. The     patients will undergo an evaluation including history and physical examination as well as     necessary laboratory tests. The proper dose of Omeprazole will then be determined in each     patient . The proper dose of Omeprazole is considered the minimum amount of omeprazole     required to lower gastric acid to a safe level.      Every year patients participating in this study will undergo a physical examination and     history. They will be questioned about symptoms associated with Zollinger-Ellison Syndrome.     Gastric acid levels will be taken and evaluated and patients will undergo an upper     gastrointestinal endoscopy.      The effectiveness of the treatment will be measured by a clinical history to determine the     control of symptoms due to high levels of gastric acid secretion.   "
161644|NCT00001192|"     This study will allow researchers to use various types of tests to evaluate cognitive and     sensory functions. These tests, referred to as batteries will evaluate attention, executive     functions, general intellectual functioning, language, memory, motor functions, orientation,     personality, selected sensory and perceptual functions, vigilance (alertness), and     visual-spatial functions. Children and adult patient will receive different test batteries.      The goals of this research study are to;        1. Create descriptions based on the performance of each patient on the test batteries. Then          use this information to relate patient behavior to their neurophysiological,          neuroradiological, and biochemical descriptions.        2. Define subgroups of patients based on their neurobehavior in order to decrease the          variability of psychiatric diagnoses, treatments, and prognoses.   "
161645|NCT00001193|"     This study is designed to evaluate the efficacy of high dose melphalan and autologous bone     marrow transplantation given as consolidation therapy to patients with inflammatory or     metastatic carcinoma of the breast in complete remission. All patients entered will receive     induction therapy with cyclophosphamide, adriamycin, methotrexate and 5-fluorouracil with     hormonal synchronization utilizing tamoxifen and premarin as in a previous Medicine Branch     protocol (MB-160C). Among patients with inflammatory carcinoma of the breast, pathologic     complete responders will receive irradiation to the breast and regional lymph nodes;     convertible partial responders and clinical complete responders with residual disease on     biopsy will undergo surgical resection of bulk disease followed by irradiation of the chest     wall and regional lymph nodes excluding the axilla. Both groups of responders will be     randomized to receive either systemic consolidation therapy with high dose melphalan (180     mg/M2 total dose over 3 days) and autologous bone marrow transplantation followed by     maintenance therapy or maintenance therapy alone. Complete responders in this noninflammatory     group will not receive further therapy since, historically, they have done well following     induction and local therapy, with maintenance therapy alone.      Patients with metastatic breast cancer will be assessed for response throughout induction     therapy. Complete and convertable partial responders will receive consolidative therapy and     be randomized to ABMT followed by 6 months of maintenance therapy vs. maintenance alone.   "
161646|NCT00001194|"     This protocol is designed to investigate the use of novel techniques in MRI that may not yet     be commercially available. Specifically, the protocol enables patients to take advantage of     new pulse sequence software, coil design or post processing capabilities not otherwise     available. The informed consent explains MRI in lay terms, describes the use of contrast     agents and lists contraindications to MRI.   "
161647|NCT00001195|"     Researchers would like to determine normal ranges for hormone levels and to learn more about     the genetics involved in hormone production and action. Researchers will take samples of     blood, urine, saliva, and stool from healthy children ages 5-17 in order to study different     aspects of hormones.      Establishing a range of normal hormone levels in children will make diagnosing illnesses with     abnormal levels of hormones much easier. Hormone levels in the body can change throughout the     day. By collecting samples at different times researchers hope to learn more about the normal     daytime and nighttime patterns of hormone secretion. Because some hormone levels change with     body size, researchers will also take measurements of patient's body composition.      This study will involve children and observe them as inpatients or as outpatients. <TAB>   "
161667|NCT00001218|"     Our past ultrasound research has indicated a need for baseline normative tongue data against     which to compare our disordered speech populations. Subjects with normal speech and hearing     who represent different ages and sexes, will be studied with respect to tongue shape and     movement patterns. Recently developed parameters such as curve fitting, curve averaging, and     polar coordinates will be used to create baseline data categories. In addition, new     parameters and improved instruments will be developed as previously to produce a data base     which can be used across disciplines.   "
161661|NCT00001212|"     Studies have shown that up to 26% of patients with systemic lupus erythematoses nephritis may     suffer from membranous lupus nephropathy. The disease is characterized by high levels of     protein in the urine and may eventually lead to kidney failure.      This study will evaluate the effectiveness and toxic effects of immunosuppressive drug     therapy in patients with membranous lupus nephropathy over a 12 month period. The major goal     of this therapy is to decrease protein losses and ultimately prevent kidney failure.      Patients enrolled in the study will undergo a routine history and physical examination. In     addition, several diagnostic tests will be conducted including; chest x-ray ECG, blood and     urine laboratory tests.      Patients will be divided and grouped according to the severity of their disease as shown by     kidney function. Each group will then randomly be subcategorized by different treatment     plans. Each treatment plan will made up of immunosuppressive medications including     prednisone, cyclophosphamide, cyclosporin A, and combinations of these drugs. Patients will     receive the medications as directed by the study.      The study will last 12 months and require patients to be admitted for two to five days before     the study begins and once the study is completed. Patients will be followed as outpatients     throughout the 12 month study.   "
161648|NCT00001196|"     This study will evaluate patients with complaints of dry mouth to determine the cause and     severity of their salivary gland dysfunction and their possible eligibility for other NIDCR     protocols. Salivary gland secretions have antibacterial, lubricatory, remineralizing,     digestive, buffering and cleansing properties. Impaired function of these glands can cause an     increase in tooth decay; a variety of oral hard and soft tissue changes, with painful,     burning, or ulcerated oral mucosal; problems chewing, swallowing, and speaking; and     diminished taste and smell.      Patients with dry mouth complaints suggestive of salivary gland dysfunction may be eligible     for this study. In addition, patients with recent onset of arthritis may enroll. Patients     with arthritis are at risk for developing a disorder called Sjogren's syndrome, in which the     glands that produce saliva may be damaged.      Participants will have a complete medical and dental history. Saliva samples will be     collected from the major salivary glands, which are located in the cheeks and under the jaw.     Several blood samples will also be drawn for tests. Some patients will have a biopsy of the     minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis of     Sjogren's syndrome and determine the extent of changes in the salivary glands. The ability to     taste and smell may also be evaluated, and patients may have an ultrasound examination of     their swallowing function.   "
161649|NCT00001197|"     A total of fifty severely affected patients with homozygous sickle cell disease or other     sickling disorders (e.g. B negative or B positive Thalassemia/Sickle) who are greater than 18     years of age will be eligible for treatment. Such patients must be able to tolerate an     extensive period without blood transfusion and have relatively well preserved renal and     hepatic function (creatinine less than 1.5 mg/dl and normal liver function test with     exception of a mild elevation in transaminase). Evidence of severe sickle cell anemia will     include recurrent pain crisis, chronic bone oain, evidence of aseptic necrosis with symptoms,     and intractable leg ulcer, etc.      On admission to the study, each patient will receive a complete history and physical     examination. These data and standard laboratory evaluation, including a test for pregnancy if     appropriate, will be adequate to ascertain whether any of the criteria for exclusion are     present. Each patient must accept responsibility for for using an effective means of     contraception. Patients who are found to be HIV positive will be excluded from the study.   "
161650|NCT00001198|"     A study of children and adolescents (current N=100) with very early onset by age 12 (COS) of     DSM-III-R defined schizophrenia with (97-M-0126) is examining the clinical, neurobiological,     early neurodevelopmental, genetic, and clinical drug response characteristics of these cases.     Earlier studies have documented the continuity between COS and adult onset cases (See     Jacobsen and Rapoport, 1998 for review). The focus has now shifted to increasing the sample     size and evaluation of familial risk factors including: psychiatric diagnoses of family     members; smooth pursuit eye movements; neuropsychological tests deficits, and obtaining blood     for cell lines for genetic studies (family members only, this is also covered under     96-M-0060, Dr. Ellen Sidransky).      A study of obstetrical records of COS probands indicated no increase in adverse pre or     perinatal events for these cases compared with obstetrical records of their siblings     (Nicolson et al submitted). In contrast, several findings point to increased risk for these     probands. To date, a total of 5 (10.4%) COS subjects were found to have previously unknown     cytogenetic abnormalities (Microdeletion of 22q11 (3 cases), (Usiskin et al, submitted),     Mosaic 45X0 (one case) (Kumra et al, 1998) and balanced 1:7 translocation (Gordon et al     1994).      The study of first degree relatives of these very rare cases addresses the hypothesis that     risk factors, most probably genetic, are increased in immediate family members relative both     to community controls and to the relatives of patients with chronic, treatment resistant,     adult-onset schizophrenia (AOS). A second hypothesis is that COS familial risk factors show     significant relationship to the developmental delays/abnormalities being observed in the COS     probands. As a total of 50 additional COS subjects will be studied over the next 5 years, the     pediatric control sample for the probands will also be increased, determined by the need to     have concurrent measures for patients and controls to maintain measurement validity. Thus a     total of 600 additional subjects are to be studied including 50 controls for COS probands,     150 COS relatives, 150 controls for COS relatives, and 250 relatives of adult onset     schizophrenics (AOS).   "
161651|NCT00001201|"     The peripheral nervous system is the portion of the nervous system outside of the brain and     spinal cord. It includes the 12 pairs of cranial nerves, 31 pairs of spinal nerves and their     branches, nerves responsible for sensation and maintenance of normal body functions     (sympathetic and parasympathetic nerves).      Years of research using clinical examinations, microscopic examinations, and     electrophysiology have made the peripheral nervous system the best-studied and most available     portion of the nervous system. However, even with all of the extensive studies conducted on     the peripheral nervous system, many conditions remain unclassified.      The EMG Laboratory at the NIH concentrates on studying disorders of the peripheral nervous     system. This protocol was designed to allow the EMG Laboratory to;      I) Learn more about established diseases of the peripheral nervous system      II) Identify and characterize new diseases of the peripheral nervous system      III) Assess current techniques in the diagnosis of diseases of the peripheral nervous system      IV) Refine old methods and develop new ones for the diagnosis of diseases of the peripheral     nervous system.   "
161652|NCT00001202|"     This study is a continuation of two previous studies conducted at the NIH. The first study ,     Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone     Analog (D-Trp(6)-Pro(9)-Net-LHRH) had less than optimal results. Some patients, all of whom     were diagnosed with familial isosexual precocious puberty, had an inadequate response to the     medication and were observed to have high levels of testosterone, advanced bone aging, and     other complications of the disease. As a result these patients were enrolled in a second     study      In the second study, Spironolactone Treatment for Boys with Familial Isosexual Precocious     Puberty, - the patients received another medication, spironolactone (Aldactone). The drug     blocked the effects of testosterone, -but bone age advancement did not improve. Some patients     began experiencing gynecomastia (an abnormal growth of the male breasts). Researchers believe     these may be the effects of elevated levels of estrodiol (a form of the female hormone,     estrogen).      In the present study, testolactone is added to the drug regimen to block the production of     estrogen. The study therefore uses spironolactone to prevent the action of the male hormones     (androgen) and testolactone to block the production of female hormones (estrogen).     Deslorelin, an LHRH analog which works by turning off true (central) puberty, is added to the     drug regimen once true puberty begins. This is because it is know that boys with familial     male precocious puberty go into true puberty too early (despite treatment with spironolactone     and testolactone), and when that happens, the spironolactone and testolactone are no longer     as effective. The goal of the treatment is to delay sexual development until a more     appropriate age and prevent short adult stature (height).   "
162263|NCT00002133|"     To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients     with oropharyngeal candidiasis that is refractory to fluconazole.   "
161653|NCT00001203|"     When patients receive repeated blood transfusions the level of iron in the patient s blood     can rise. When iron is processed in the body a protein known as hemosiderin can begin     collecting in the organs. If too much hemosiderin collects in the organs they can begin to     malfunction. This condition is called transfusional hemochromatosis.      An organ of particular importance in transfusional hemochromatosis is the heart. Patients     born with diseases requiring blood transfusions at birth begin to develop heart problems in     their teens. These patients typically only live for 17 years. Adults that require     transfusions can begin experiencing heart problems after 100-200 units of backed red blood     cells.      Deferoxamine (Desferal) is a drug that binds to iron and allows it to be excreted from the     body. It is the only effective way to remove iron from patients who have been overloaded with     iron because of multiple transfusions. Previous studies have lead researchers to believe that     deferoxamine, when given as an injection under the skin (subcutaneous), can be delay or     prevent heart complications.      Researchers plan to continue studying patients receiving deferoxamine as treatment for the     prevention of heart complications associated with repeated blood transfusions. In this study     researchers will attempt;        1. To determine if deferoxamine, given regularly, can indefinitely prevent the heart,          liver, and endocrine complications associated with transfusional hemochromatosis        2. To determine whether heart disease caused by transfusional hemochromatosis can be          reversed by intensive treatment with deferoxamine.   "
161654|NCT00001204|"     Homozygous familial hypercholesterolemia is a rare inherited disease of metabolism. It occurs     in less than 1 in 1 million people within the United States. Patients with the disease are     typically children and young adults who develop heart disease early in life. Children less     than age 5 years with this disease have suffered heart attacks and death.      The normal process that removes cholesterol particles from the blood stream does not work in     patients with this disease. It causes cholesterol to build-up in the arteries and leads to     hardening of the arteries (atherosclerosis).      The goal of this study is to detect and measure atherosclerosis in these patients before it     becomes permanent and potentially life threatening. Patients with this disease can     participate in this study. Researchers plan to evaluate patients with homozygous familial     hypercholesterolemia using new and standard methods for detecting atherosclerosis.      Researchers plan to use information gathered during this study to develop new, promising     treatments such as liver transplantation and gene therapy.   "
161655|NCT00001205|"     The purpose of this study is to evaluate, treat and follow patients with cysticercosis, an     infection with the larval form of the pork tapeworm, T. solium. When people ingest cysts of     T. solium eggs, cysts develop in the muscles, brain and other organs. The cysts enlarge and     cause inflammation, usually in the brain. Patients may develop seizures, headache, nausea,     vomiting, inability to walk, poor vision due to enlargement of the brain, and increased     pressure in the brain. Other neurological problems may develop depending on the location of     the cysts. The drugs praziquantel and albendazole are used to treat cysticercosis, but it is     not clear if these drugs are effective in all patients, such as those with calcified cysts or     brain enlargement.      Patients with suspected or confirmed cysticercosis may be eligible for this study.     Participants will be hospitalized for 2 to 3 weeks and will take either praziquantel or     albendazole by mouth for 2 weeks. They may receive a corticosteroid to lessen the side     effects of the drug therapy. Patients will be evaluated with medically indicated tests and     procedures that may include:        -  Blood tests.        -  X-rays of the head and long bones.        -  Electroencephalogram recording of the electrical activity of the brain        -  Lumbar puncture (spinal tap) examination of the cerebrospinal fluid that bathes the          brain and spinal cord. For this procedure, a local anesthetic is given and a needle is          inserted in the space between the bones (vertebrae) in the lower back. About 2          tablespoons of fluid is collected through the needle.        -  Eye examination.        -  Magnetic resonance imaging (MRI) to examine the brain. MRI uses a strong magnetic field          and radio waves instead of X-rays to demonstrate structural and chemical changes in the          brain. During the scan, the patient lies on a table in a narrow cylinder (the scanner).          He or she can speak with a staff member via an intercom system at all times during the          procedure.        -  Computed tomography (CT) to examine the brain. CT can be done from different angles and          allows the doctor to view the brain in small sections in 3-dimensions. The patient lies          on a table with the head positioned in the CT scanner.      Some of the tests may be repeated on the last day of therapy and at 3 and 6 months or longer     after therapy.   "
161656|NCT00001206|"     The purpose of this study is to evaluate individuals with Attention Deficit/Hyperactivity     Disorder (ADHD) to learn more about the genetics of the disease.      This study is part of other ongoing studies of individuals with ADHD. The study participants     have already undergone neurobiological measurements, particularly magnetic resonance imaging     (MRI) of the brain, through other research studies. As a follow-up to these studies,     participants will next undergo psychiatric interviews, neuropsychological tests, and another     MRI. In addition to the clinical evaluation of the participants, further research will be     conducted on the genetics of ADHD. These genetic studies will evaluate people with ADHD as     well as their family members and a control group of healthy people.   "
161658|NCT00001209|"     This protocol is designed to test the feasibility of the administration of vincristine,     adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well     as the efficacy of this therapy in addition to radiotherapy in producing complete responses     and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone,     peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but     will be comparable to the large data base of similar patients treated on successive Pediatric     Branch studies.   "
161659|NCT00001210|"     Subjects are healthy adult volunteers either at high risk for HIV infection or already known     to be seropositive, who will donate blood for in vitro tests of T-cell function and in vitro     responses to synthetic peptides corresponding to sequences from HIV proteins.   "
162167|NCT00002037|"     To examine the effectiveness of subcutaneous gamma interferon in reducing severity of     Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an     open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety     of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence     and absence of AZT therapy.   "
161688|NCT00001242|"     Patients with confirmed or suspected conditions with a resistance to vitamin D or parathyroid     hormone (PTH) will be admitted for diagnosis and treatment, and inclusion in other studies     pertaining to similar conditions.      This study will provide information about problems relating to calcium in the blood, urine,     and bones. Patients in this study will undergo a general evaluation / check-up to give     researchers an idea of each person's condition or disease. Patients will receive treatment     based on their diagnosis and asked to provide specimen samples for further research studies.   "
161783|NCT00001337|"     5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. EPOCH: Etoposide,     VP-16, NSC-141540; Prednisone, PRED, NSC-10023; Vincristine, VCR, NSC-67574;     Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; with Granulocyte     Colony-Stimulating Factor (Amgen), G-CSF, NSC-614629.   "
161662|NCT00001213|"     Cystinosis is an inherited disease that results in poor growth and kidney disease, among     other things. The damage to the kidneys and other organs is thought to be due to accumulation     of cystine inside the cells of various body tissues. This chemical also accumulates in the     cornea-the covering of the eye over the pupil and iris. After 10 to 20 years, the corneas of     some patients become so packed with crystals that the surfaces may become irregular,     occasionally causing small, painful breaks.      Patients enrolled in a NIH study on cystinosis are receiving the drug cysteamine. Taken by     mouth, this drug reduces cystine in some tissues, but not in the cornea. This study began in     1986 to test whether cysteamine eye drops could prevent or reduce corneal cystine crystals in     these patients. The drops have been very effective in removing crystals and reducing pain in     patients who take the medication as directed. Patients who do not take the medication as     prescribed do not benefit.      After the effectiveness of the drops was proven, the main purpose was modified to continue to     evaluate the long-term safety and effectiveness of cysteamine eye drops for treating cystine     crystals in the corneas of patients with cystinosis until the drops are approved by the Food     and Drug Administration (FDA). When the New Drug Application (NDA) for the Sigma-Tau standard     formulation is granted, this protocol will be terminated.   "
161663|NCT00001214|"     Aplastic anemia is a condition in which the cells normally found in blood are greatly     decreased. The normal levels of white blood cells, red blood cells, and platelets are much     lower in patients with aplastic anemia.      Because of these low levels of blood cells, patients with aplastic anemia have a variety of     immune system abnormalities. However, low levels of blood cells make it difficult to collect     specialized white blood cells (mononuclear cells) for research studies.      This study was designed to collect lymphocytes from patients with low levels of all blood     cells (pancytopenia) for use in research. Patients participating in the study will undergo a     special procedure known as lymphapheresis. During lymphapheresis blood is taken from the     patient in a manner similar to blood donation. The white blood cells are selectively removed     by spinning (centrifugation), and the remaining red blood cells and platelets are placed back     (re-infused) into the donor s blood stream.      Patients participating in this study will not benefit directly from it. However, cells     collected in this study may increase scientific knowledge and improve understanding and     treatment for diseases like aplastic anemia.   "
161664|NCT00001215|"     The purpose of this study is to identify genetic, biochemical, and clinical factors that are     associated with disease severity in people with Gaucher disease and other lysosomal storage     disorders.      There is a vast spectrum of clinical manifestations in people with Gaucher disease as well as     other lysosomal storage disorders. This study will evaluate patients with lysosomal disorders     on an outpatient or inpatient basis in order to better characterize the clinical, genetic,     and pathophysiological features of these disorders. Participants will be re-evaluated on an     annual basis.   "
161665|NCT00001216|"     This study is designed to allow researchers to use transelectrical stimulation to explore the     function of the human nervous system and improve diagnosis of neurological disorders.      Transcranial electrical stimulation is a non-invasive technique that can be used to stimulate     brain activity and gather information about brain function. Electrical stimulation involves     placing electrodes on the scalp or skin and passing an electrical current between them. When     this is done, an electrical field is created that activates areas of the brain that control     muscles. Muscle activity as a result of the stimulation can be recorded and analyzed.   "
161666|NCT00001217|"     The study is designed to determine if the administration of multi-drug adjuvant chemotherapy     for patients with primary non-metastatic osteogenic sarcoma, both prior to and after the     definitive surgical procedure for their primary tumor is superior as a treatment strategy to     the current approach of giving drugs only after the definitive surgical procedure has been     performed. An effort will be made as well to determine if the administration of     pre-definitive surgery, chemotherapy leads to an increase in the proportion of the patients     suitable for a limb salvage primary surgical procedure.   "
162283|NCT00002153|"     To evaluate topical A-007 in patients with advanced malignancies including Kaposi's sarcoma     and lymphoproliferative disorders.   "
161668|NCT00001219|"     Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) are diagnostic     tests that allow researchers to look at different chemical properties of tissue. Magnetic     resonance imaging and spectroscopy studies can be used to gather or evaluate information     about various aspects of patient s bodies or to monitor changes in the biochemistry and     physiology of patient s bodies.      Unlike other diagnostic techniques (CT scan and PET scan) MRI and MRS do not use ionizing     radiation. Some studies have shown that MRI is more effective at distinguishing normal parts     of the anatomy from abnormal anatomy, especially in the brain. MRI has become the diagnostic     test of choice for evaluating patient with multiple sclerosis.      The purpose of this study is to evaluate normal volunteers and patients with a variety of     diseases with magnetic resonance imaging. Researchers will attempt different magnetic     resonance imaging methods and techniques as well as different levels of magnetic strength.   "
161669|NCT00001220|"     This study will identify clinical signs and symptoms critical for diagnosing swallowing     disorders and will characterize swallowing problems in various patient populations, such as     patients with Parkinson's disease, stroke, post-polio syndrome, multiple sclerosis and other     conditions that cause swallowing abnormalities.      Patients with swallowing difficulties who are enrolled in NIH neurology or speech pathology     protocols may be eligible for this study. Participants will undergo the following procedures:        1. Oral examination-A neurologist and speech pathologist examine the patient's swallowing          function. The patient is interviewed about difficulties with food intake, chewing and          swallowing during meals.        2. Ultrasound examination-Ultrasound creates image of areas inside the body using sound          waves. With the patient in a sitting position, a 3/4-inch transducer (device for          transmitting and receiving sound waves) is placed under the chin to visualize tongue          movements during swallowing.        3. Modified barium swallow-While standing or sitting, the patient swallows 1/2 teaspoon of          flavored barium (a radioactive substance) six times (a total of 3 teaspoons), while the          tongue and pharynx (tube leading from the mouth to the esophagus) are scanned and          videotaped. The barium is given in three consistencies-thin, medium and thick          (pudding-like).        4. Electromyography-A small plastic strip with wires attached is placed under the patient's          chin. The patient then swallows 1/2 ounce of barium three times in a row, and the          movement of the chin muscles during swallowing is displayed. Patients may also be asked          to swallow 5/8 cup of barium twice; once with the head tilted upward and once with the          head untilted.      Depending on the test results, patients may be asked to return for follow-up study and     monitoring.   "
162184|NCT00002054|"     To evaluate the safety, tolerability, and description of time to Pneumocystis carinii     pneumonia (PCP) for long-term biweekly administration of 1 of 2 doses of aerosol pentamidine     when used as a prophylactic agent in patients who have had one episode of AIDS-associated     PCP.   "
161670|NCT00001221|"     Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes.     Girls with Turner syndrome are very short as children and as adults. Although their growth     hormone secretion is almost always normal, giving injections of growth hormone to Turner     syndrome girls may increase their rate of growth. In addition, most girls with Turner     syndrome do not have normal ovaries.      In normal girls the ovaries begin producing small amounts of the female sex hormone, estrogen     at about 11 - 12 years of age. As girls grow older the level of estrogen increases. Estrogen     is responsible for the changes in girls known as feminization. During feminization the hips     grow wider, the breasts develop, there is an increase in the rate of growth, and eventually     girls experience their first menstrual period.      This study was designed to evaluate the effect of low dose estrogen, growth hormone, and the     combination of low dose estrogen and growth hormone on adult height in girls with Turner     syndrome. Patients will be entered into the study from ages 5 to 12 and will be randomly     placed into one of four groups.        1. Group one will receive low dose estrogen        2. Group two will receive growth hormone        3. Group three will receive both low dose estrogen and growth hormone        4. Group four will receive a placebo sugar pill      Once started, the treatment will continue until the patients approach their adult height, and     growth slows to less than 1/2 inch over the preceding year. This usually occurs by the age of     15 or 16.      Patients will be seen at the outpatient clinic every 6 months during the study and will     receive a routine check-up with blood and urine tests, and hand/wrist X-rays to determine     bone age. On patient's yearly visits they will have the density of bone measured in their     spine and forearm.   "
161671|NCT00001223|"     Cystic fibrosis is a disease that affects many parts of the body, particularly the lungs and     pancreas. The main purpose of this study is to further understand the natural history,     clinical presentation, and genetics of cystic fibrosis.      Patients with cystic fibrosis will be asked to participate in this study by undergoing     standard medical tests and procedures. Patients will have a history taken and have a physical     examination as well as blood tests, and a sweat test (a test for cystic fibrosis of the     pancreas in which electrolytes are measured in collected sweat). Patients may also be asked     to provide samples of urine, stool, and sputum for additional tests. More complicated     procedures such as bronchoscopy or bronchoalveolar lavage may be required for diagnosis,     treatment, or research purposes.      Patients will receive appropriate treatment with antibiotics, pancreatic enzymes, vitamins,     physiotherapy, and other agents. Medications may be given by mouth or injected into a vein.      This study will provide patients with information on the prognosis of the disease as well as     recommendations for management of cystic fibrosis. In addition this study will provide     information to researchers which may be useful in other studies of cystic fibrosis.   "
161672|NCT00001224|"     The purpose of this investigation is to better understand the inflammatory process that     occurs in uveitis (eye inflammation) through study of eye tissues.      Patients with uveitis sometimes develop cataracts (clouding of the lens of the eye) or     clouding of the vitreous-the gel-like material behind the lens-that can impair eyesight.     Those who require cataract surgery or vitrectomy are eligible for this study. Samples of eye     tissue and fluid normally removed during standard surgical procedures for these conditions     will be given to researchers instead of discarded, as is usually done.      Before surgery, patients will undergo routine preoperative tests, including chest X-ray,     electrocardiogram, blood tests and urinalysis. They will also have an eye examination and     photographs taken of the retina. Other tests that may be performed include fluorescein     angiography to evaluate the blood vessels of the retina; ultrasound to examine the back of     the eye; and a gallium scan to evaluate inflammation.      Immune cells in the blood and eye tissue will be compared and categorized by disease. The eye     fluid will be examined for substances involved in the inflammatory process. These studies may     provide information that will lead to improved methods of diagnosis and treatment.   "
161717|NCT00001276|"     Hypoglycemia is the term used to refer to lower than normal levels of blood sugar. This study     will continue to research the causes of hypoglycemia.      Patients involved in the study will be admitted to the Clinical Center of the National     Institutes of Health and undergo tests for evaluating blood sugar. Patients will be required     to refrain from eating for a set period of time and will undergo blood tests for insulin     levels and several other specific diagnostic tests related to insulin secretion. The patients     will be under supervision and will be provided with appropriate medical and surgical     attention as needed.   "
161673|NCT00001225|"     Hypertrophic cardiomyopathy (HCM) is a genetically inherited heart disease. It causes     thickening of heart muscle, especially the chamber responsible for pumping blood out of the     heart, the left ventricle. Hypertrophic cardiomyopathy (HCM) is the most important cause of     sudden death in apparently healthy young people.      A genetic test called linkage analysis is used to locate genes causing inherited diseases     like HCM. Linkage analysis requires large families to be evaluated clinically in order to     identify the members with and without the disease.      In this study researchers will collect samples of DNA from family members of patients with     HCM. The diagnosis of the disease will be made by history and physical examination,     electrocardiogram (12 lead ECG), and ultrasound of the heart (2-D echocardiogram). The     ability of the researchers to locate the gene responsible for the disease improves with     increases in the size of the family and members evaluated.      In order to continue research on the genetic causes of heart disease, researchers intend on     studying families with specific genetic mutations (beta-MHC) causing HCM. Researcher plan to     also study families with HCM not linked to specific gene mutations (beta-MHC).   "
161674|NCT00001226|"     Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the     blood. This study is designed to improve understanding of normal, as well as abnormal,     lipoprotein metabolism and the role it plays in the development of hardening of the arteries     (atherosclerosis).      Patients participating in this study will receive an intravenous (directly into the vein)     injection of a small amount of specially prepared amino acids. The amino acids being injected     are the same amino acids present in a normal diet. The amount of amino acid given will be     less than the amount eaten in a protein-rich meal. The amino acids will be labeled with     nonradioactive heavy isotopes which are also present in the environment n low amounts.      Patients participating in the study will be required to have blood samples taken, and provide     urine samples throughout the course of the study. In addition, patient will be required to     follow a specially formulated diet. Patients will be weighed throughout the course of the     study.   "
161675|NCT00001228|"     This study will examine the safety and effectiveness of interferon-a and octreotide for the     treatment of Zollinger-Ellison syndrome (gastrinoma) and advanced non-B islet cell cancer.     Gastrinoma is a tumor produced by the pancreas that secretes the hormone gastrin, which in     turn stimulates production of gastric juices that cause ulcers. Some of these tumors are     malignant. Gastrinomas that have spread and cannot be surgically removed require drug     treatment (chemotherapy). Current drug regimens, however, provide only temporary benefit and,     in some cases, produce life-threatening side effects. In studies of patients with tumors     similar to gastrinoma, the drugs octreotide and interferon-a, alone or in combination, showed     some effect in stopping tumor growth and were better tolerated than chemotherapy. At least     one-third of patients responded to treatment with either drug for at least 6 months; the two     drugs given together may produce a better response than either one alone.      Patients currently enrolled in an NIH study of Zollinger-Ellison syndrome whose gastrinoma     has spread from the original site and cannot be surgically removed may be eligible for this     study.      Participants will be admitted to the NIH Clinical Center for blood and urine tests,     electrocardiogram (EKG), chest X-ray and imaging studies (CT, ultrasound, MRI, octreoscan,     and bone scan) before beginning treatment to evaluate the size and extent of tumors. Patients     will then start interferon-a or octreotide, or both, given as injections under the skin.     Treatment will continue for at least 6 months, unless side effects require stopping the drugs     early. Patients whose tumors shrink or remain stable may continue treatment indefinitely.     Those who do not respond to treatment will be taken off the study and offered standard     chemotherapy.      Patients will be admitted to the hospital for the first day or two of therapy to be monitored     for side effects and to learn how to self-inject the drugs to continue therapy at home. Both     drugs are given [Note: how often? once a day, twice a day, weekly?] (Octreotide is also     available in long-acting form, and patients who prefer may be given this drug once a month by     the doctor.)      During the treatment period, patients will be seen by their personal physician every 2 weeks     for the first month and once a month thereafter for a medical evaluation and check of adverse     side effects of treatment. In addition, they will be admitted to the NIH Clinical Center once     every 3 months for a medical evaluation and imaging studies, including CT, MRI, ultrasound,     bone scan, and octreoscan, to assess the effect of treatment on tumor size.   "
161676|NCT00001229|"     Pheochromocytoma is a tumor of the adrenal gland. This tumor is typically benign (not     cancerous) and can be cured by surgical removal. However, pheochromocytomas produce     neurohormones called cateholamines (epinephrine and norepinephrine). High levels of     catecholamines can result in high blood pressure, headaches, sweating, heart palpitations,     nausea, vomiting, and other symptoms. These tumors are considered dangerous because of their     unpredictable behavior. Patients with pheochromocytoma may experience blood pressures high     enough to cause a stroke or heart attack in patients.      This study is designed to take patients suspected of having pheochromocytoma and confirm the     diagnosis. This will be done using a variety of laboratory tests including a clonidine     suppression test and glucagon stimulation test. These tests use drugs that can stimulate or     reduce the activity of the tumor if it is present in the body.      Once a diagnosis is confirmed, patients participating in this study will undergo standard     procedures to find the exact location of the tumor and receive standard therapy for the     condition.   "
161677|NCT00001230|"     This study will evaluate and treat patients with filarial infections to explore in depth the     immunology of the disease, including susceptibility to infection, disease development, and     response to treatment. Filarial infections are caused by parasitic worms. The immature worm     (larva) is transmitted to a person through a mosquito bite and grows in the human body to 2     to 4 inches in length. Although many of these infections do not produce symptoms, especially     in the early stages of infection, others can have serious consequences, including swelling of     the limbs or genitalia, allergic-lung problems, skin rash, eye inflammation that can lead to     blindness, and heart disease. This protocol does not involve any experimental diagnostic     procedures or treatments, and will use only procedures employed in the standard practice of     medicine.      Persons between 3 and 100 years of age diagnosed with or suspected of infection with     Wuchereria bancrofti, Bugia malayi, Onchocerca volvulus, Loa loa, or other parasitic worms     may be eligible for this study.      Participants will have routine tests to determine the specific type of filarial infection.     These may include special tests of the lungs, skin or heart, depending on the type of     parasite suspected. Patients with skin reactions may have a punch biopsy to examine a small     piece of affected skin. For this procedure, an area of skin is numbed with an anesthetic and     a small circular area, about 1/3-inch in diameter and 1/2-inch thick, is removed using a     sharp cookie cutter-type instrument. Some patients may require bronchoalveolar lavage. For     this procedure, the mouth and throat are numbed with lidocaine jelly and spray and, if     needed, a sedative is given for comfort. A small plastic tube is placed in a vein to give     medications. A pencil-thin tube is then passed through the nose or mouth into the lung     airways to examine the airways. Salt water is injected through the bronchoscope into the air     passage, acting as a rinse. A sample of the fluid is then withdrawn and examined for     infection, inflammatory cells and inflammatory chemicals. (Bronchoalveolar lavage is done     only if medically necessary and only on patients 21 years or older.) Once the diagnosis is     established, standard treatment will be instituted with either diethylcarbamazine or     ivermectin, depending on the type of infection.      Additional procedures for research purposes include:        -  Extra blood draws to study immune cells and other immune substances. (This is the only          research procedure that will be done in - More frequent and extensive follow-up          evaluations than usual for routine care. They will include physical examination and          blood studies.        -  Urine collections at specified periods, possibly including 24-hour collections.        -  Skin tests to examine the body s reaction to allergens-common environmental substances,          such as cat dander or pollen-that cause an allergic reaction. The test is done in one of          two ways: either the skin is lightly scratched and an allergen extract is placed over          the just-broken skin, or a very fine needle is used to inject a small amount of allergen          under the skin. In both methods, the site is monitored for swelling or hives in the next          48 hours.        -  Leukapheresis (only on patients 21 or older ) to collect quantities of white blood          cells. Whole blood is collected through a needle in an arm vein, similar to donating          blood. The blood circulates through a machine that separates it into its components, and          the white cells are removed. The rest of the blood is returned to the body, either          through the same needle or through another needle in the other arm.   "
161678|NCT00001231|"     The purpose of this study is to investigate mood and behavior changes in the time period     surrounding and including menopause. This is an observational study; volunteers who     participate will not receive any new or experimental therapies.      Controversy exists regarding the relationship between estrogen and progesterone (gonadal     steroid) changes and midlife-onset depression. This study will examine the role of gonadal     steroids in perimenopausal mood and behavioral disorders.      Perimenopausal women with depression symptoms and a control group of healthy perimenopausal     volunteers will be compared to identify correlates of the occurrence of depression.     Participants with depressive symptoms may also participate in companion studies that will     test the antidepressant efficacy of phytoestrogens and selective estrogen receptor modulators     (SERMS).      A group of younger pre-perimenopausal women with normal menstrual cycle functioning will be     followed through menopause in an effort to confirm the association of depression onset with     changes in reproductive endocrine functioning.   "
161679|NCT00001232|"     The normal menstrual cycle is produced by a series of hormonal signals that starts with the     release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. The hypothalamus is     located in the brain and is often referred to as the master gland. GnRH then acts on the     pituitary gland and causes it to release two hormones, follicle stimulating hormone (FSH) and     lutenizng hormone (LH). LH and FSH act on the ovary and cause it to release the hormones     directly involved in menstruation, estrogen and progesterone.      The purpose of this research study is to evaluate the hypothalamic-pituitary-gonadal axis     activity as measured by pituitary hormones, FSH and LH in response to intravenous doses of     gonadotropin releasing hormone (GnRH) in menstrual cycle-related hormones.   "
162284|NCT00002154|"     The purpose of this study is to see if it is safe and effective to give thioctic acid and     deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who     have mild to moderate dementia (a decline in their mental abilities).   "
161680|NCT00001233|"     A conduct disorder is characterized by repetitive and persistent patterns of behavior where     the basic rights of others and rules are violated.      This study investigates characteristics of children and their surroundings (environments)     that place them at risk for the development of disruptive behavior disorders and associated     disorders of anxiety and mood. Children ages 4 - 5 with moderate (subclinical) and severe     (clinical) rates of misconduct during the preschool period are compared to low risk children.     Children and their families were recruited from 1989-1991 and are being studied at five     specific times:        1. Preschool (4 - 5 years)        2. Early childhood (6 - 7 years)        3. Middle childhood (9 - 10 years)        4. Early adolescence (13 - 14 years)        5. Mid-adolescence (15 - 16 years)      Researchers will look closely at biological, intellectual, emotional, and behavioral factors     that are thought to protect against and/or increase the risk of developing a conduct problem.     These factors have been studied in older children and are shown to be associated with     disruptive behavior disorders.      The goals of this research study are;        1. Create a database showing the characteristics of the development of disruptive behavior          problems.        2. Identify the key risk and protective factors that contribute to the stability or change          in behavior problems over time.        3. Identify the ways that children interact socially and relate them to the possibility of          developing a problem of behavior.        4. Identify how experiences and the emotions associated with experiences may play a role in          the development of related psychiatric conditions, like depression and anxiety.        5. Establish measures of the different components of negative emotions associated with          disruptive/antisocial, anxiety, and mood disorders.   "
161764|NCT00000753|"     To determine the safety, toxicity, pharmacokinetic profile, and antiretroviral activity of     atevirdine mesylate ( U-87201E ) in HIV-infected patients. Per 06/04/93 amendment, to also     evaluate the interactive effects of didanosine ( ddI ) or zalcitabine ( dideoxycytidine; ddC     ) with zidovudine ( AZT ) on the pharmacokinetics of U-87201E and to assess the effects of     the triple combination therapies on immunologic and virologic parameters.      Since the use of non-nucleoside reverse transcriptase inhibitors such as U-87201E has been     associated with the rapid development of resistant HIV isolates, an initial evaluation of     this drug in patients was made in combination with AZT. Because of the inability to detect     resistance after 6 weeks of combined AZT/U-87201E therapy, this protocol will initially     investigate U-87201E administered alone and then investigate the effect of this drug with AZT     and ddI or ddC.   "
162185|NCT00002055|"     To evaluate and compare the safety, tolerability, and effectiveness of long-term biweekly     administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in     patients who have had multiple episodes of AIDS associated Pneumocystis carinii pneumonia     (PCP).   "
161681|NCT00001234|"     Gaucher's disease is a lysosomal storage disease resulting from glycocerebroside     GLUCOCEREBROSIDE (1) accumulation in macrophages due to a genetic deficiency of the enzyme     glucocerebrosidase. It may occur in patients of all ages. The most severe form, Type 2     Gaucher's Disease occurs in infants who die in the first years of life (with rapidly     progressive neurologic deterioration). The condition is passed from generation to generation     through autosomal recessive inheritance.      Fabry's disease isa genetic disorder (X-linked recessive) due to the absence of the enzyme     a-galactosidase A. The disease is characterized by abnormal collections of glycolipids in     cells (histiocytes) within blood vessel walls, tumors on the thighs, buttocks, and     genitalia(2) decreased sweating, tingling sensations in the extremities, and cataracts.     Patients with Fabry's disease die from complications of the kidney, heart, or brain.      Both conditions are caused by the absence of specific enzymes (3). Patients with these     conditions are missing (3) or have defective genes needed for the normal production of these     enzymes. Studies on the blood-forming cells in bone marrow have lead to gene therapies using     retroviruses as vehicles to carry and insert working genes into abnormal or diseased cells.      This study is designed to measure the safety and effectiveness of transferring working copies     of genes responsible for making missing enzymes into the cells of patients with Gaucher's or     Fabry disease.   "
161682|NCT00001235|"     Alzheimer's disease is a condition marked by the deterioration of mental function. The     disease usually begins in late middle life and results in death in 5 to 10 years. Patients     with Alzheimer's disease typically suffer from memory loss, confusion, and disorientation.     The condition has become a major medical and social problem in the United States because of     the increasing number of people living beyond the age of 65. The actual cause of Alzheimer's     disease is unknown.      Researchers believe that Alzheimer's disease, or at least a portion of cases, may be an     inherited condition. As a result, many new techniques have been developed to study the     genetic causes of Alzheimer's disease and other neurological disorders. Many of these genetic     techniques require blood samples and a family pedigree. A pedigree is a chart, similar to a     family tree, that shows a patient's family history.      The purpose of this study is to collect family and psychosocial information, blood, and     biopsy samples from patients with neurological diseases, their families, and normal     volunteers. This information gathered will be used to learn more about diseases that affect     the brain.   "
161683|NCT00001237|"     Major improvements in the treatment of childhood non-lymphoblastic lymphomas have taken place     in the last ten years. Though the survival rate in low risk patients (i.e., those with stage     I & II disease and serum LDH of less than 350 IU/dL) was as high as 90% with the previous     Pediatric Branch protocol, only 32% of patients in the high risk group achieved long term     remission. The present protocol is designed to improve survival in the high risk group by     using alternating non-cross resistant drug regimens. We plan to determine whether using     granulocyte-macrophage colony stimulating factor (GM-CSF) in this group would increase     dose-intensity and ameliorate myelotoxicity. We also plan to study the effect on survival of     decreasing the duration of treatment to three months from the present year-long therapy in     low-risk patients.   "
161684|NCT00001238|"     We will investigate the clinical manifestations and molecular genetic defects of heritable     urologic malignant disorders. Families with urologic malignancy with known or suspected     genetic basis will be enrolled. Affected individuals or individuals suspected of having a     germline urologic malignant disorder will undergo periodic clinical assessment and genetic     analyses for the purpose of: 1) definition and characterization of phenotype, 2)     determination of the natural history of the disorder, and 3) genotype/phenotype correlation.     Genetic linkage studies may be performed in situations in which the genetic basis of the     disorder has not been elucidated.   "
161685|NCT00001239|"     To evaluate a dose intensive chemotherapy regimen for the treatment of locally advanced and     metastatic breast cancer using granulocyte-macrophage colony-stimulating factor (GM-CSF) to     ameliorate chemotherapy-induced toxicity. Combination chemotherapy consists of Flurouricil,     Leucovorin, Adriamycin, and Cytoxan (FLAC) which will be given every 21 days for 10 cycles.     This protocol will replace the phase I study of this regimen (MB-232/88-C-0207) which found     the MTD of this regimen to be at the first dose level. This is a phase II study to determine     response rates of this regimen in advanced breast cancer.   "
161686|NCT00001240|"     This study is used by the Digestive Diseases Branch to evaluate patients with suspected     abnormalities in the secretion of gastric acid. The level of gastric acid is measured by     analyzing the gastric juices of each individual patient. The gastric acid sample is obtained     by a procedure known as nasogastric suctioning, where a thin plastic tube is passed from the     nose to the stomach.      Depending on the patient's present condition further diagnostic testing may be required to     achieve a diagnosis.   "
161772|NCT00000761|"     PRIMARY: To determine the safety and toxicity of recombinant interferon gamma-1b ( rIFN-gamma     ) in HIV-infected children receiving ongoing zidovudine ( AZT ) or didanosine ( ddI )     therapy. To document HIV-associated defects in neutrophil and/or monocyte function that are     improved with rIFN-gamma.      SECONDARY: To determine whether a change in CD4 cell count occurs and to assess virologic     status and effects on AZT and ddI pharmacokinetics.      It is likely that infants and children severely immunocompromised by HIV infection would     respond to immunomodulators that augment different portions of the host defense system.     Interferon-gamma has been shown to benefit children with severely compromised nonspecific     immunity and may thus be of benefit to those with HIV infection.   "
161687|NCT00001241|"     In patients with Zollinger-Ellison Syndrome the level of gastric acid is elevated. This     increased level of gastric acid is what causes the symptoms of the disease. Certain types of     medication can control the secretion of gastric acid. In this study there are details on how     drugs known as antihistamines (H2 receptor antagonists) can control the levels of gastric     acid secretion.      The study describes; which patients are candidates for this research, what to do prior to     initiating treatment, and the appropriate dose of antihistamine to be given.      Initial doses of the medication will be given intravenously (injected through a vein) and     later doses will be administered orally (by mouth).      By following the procedure, researchers will be able to determine if there is a more     effective route of drug administration, as well as the effectiveness of antihistamines in     patients treated surgically for Zollinger-Ellison pancreatic tumors with mildly elevated     gastric acid levels.   "
161689|NCT00001243|"     This study will examine the effects of HIV on bone marrow cells. Various types of cells from     bone marrow will be studied to learn which cells become infected with HIV, what changes occur     in the number of or growth patterns of the cells, what kinds of proteins the cells make in     the presence or absence of HIV and whether the cells can function normally.      HIV-infected and non-infected individuals 18 years of age and older may participate in this     study.      Participants will undergo the following procedures:        -  Blood draw: Blood will be drawn through a needle from a hand or arm vein. About 150          milliliters (10 tablespoons) will be collected each time. No more than 450 ml (30          tablespoons) will be taken over a 6-week period.        -  Bone marrow aspirate: Bone marrow will be drawn from the hipbone. For this procedure, a          local anesthetic is injected in the skin over the hipbone. A small needle is put about          1/2-inch through the shell of the bone and about 3 to 4 teaspoons of marrow are drawn          from the cavity into a syringe.      White cells from marrow of uninfected individuals may be infected with HIV in the laboratory     and grown over time for study. Alternatively, uninfected cells may be used as controls to     compare with cells from HIV-infected individuals.      White cells from marrow of HIV-infected individuals will be grown in the laboratory and     studied in comparison with cells from uninfected individuals. Or, bone marrow cells may be     injected into immune-deficient mice to try to develop an animal model for HIV infection.     White blood cells will also be studied in the laboratory to learn how the immune system     responds to HIV infection.   "
161690|NCT00001244|"     This study will explore the cause of immunodeficiency in common variable immunodeficiency     (CVI) and other related immunodeficiency syndromes IgA deficiency, hyper IgM syndrome,     thymoma and agammaglobulinemia, hypogammaglobulinemia associated with Epstein-Barr infection,     and others to better focus on how to correct the underlying defect.      Patients with CVI and their family members may participate in this study. Family members must     be between the ages of 18 and 85, in good health and weigh at least 110 pounds.      Patients will receive standard medical care for their illness. Procedures may include a     medical history and physical examination, routine blood tests, stool examination for     infectious agents, lung function tests, chest and sinus X-rays. Treatment may include     administration of immune serum globulin, antibiotics for infections, and anti-inflammatory     drugs, if needed. In addition, patients may undergo the following:        -  Lymphapheresis: This procedure is done to collect large numbers of white blood cells          (lymphocytes). Blood is collected through a needle in an arm vein, similar to donating          blood. The blood is separated it into its components by centrifugation (spinning), the          white cells are removed, and the rest of the blood (red cells, plasma and platelets) is          returned to the body, either through the same needle or through another needle in the          other arm.        -  Blood draw: Blood may be drawn through a needle in an arm vein (venipuncture). No more          than 450 milliliters (15 ounces) of blood will be collected over a 6-week period from          adults, and no more than 7 ml (1 1/2 teaspoons) per kilogram (2.2 pounds) of body weight          in children over the same time period.        -  Lymph node biopsies: Lymph node biopsies will be done only if required for diagnostic          purposes. Some of the biopsy tissue may be kept for research. Up to two lymph nodes may          be removed during each procedure. For the procedure, a painkiller is injected into and          beneath the skin in the biopsy area, and the node is removed surgically. The incision is          closed using dissolving sutures (stitches) that do not require removal. The biopsy takes          about 30 minutes. Patients will be hospitalized at least overnight for observation.        -  Intestinal biopsies: Endoscopy and gastrointestinal biopsy will be done only if there is          evidence of malabsorption. Some of the biopsy tissue may be kept for research. Patients          are pre-medicated to allay anxiety, but are fully conscious during the procedure. A          flexible tube is inserted into the stomach or small intestine through the mouth. The          tube allows the doctor to see the intestinal mucosa and to project the image onto a TV          screen. At various places in the mucosal surface, small pieces of tissue are plucked out          using a small space at the tip of the endoscope. The procedure takes 30 to 60 minutes.      Some of the blood collected may be used for genetic tests. Some blood and tissue samples may     be stored for future research labeled with a code, such as a number, that only the study team     can link to the patient.      Participating family members will provide a medical history, and their pulse, blood pressure     and temperature will be taken. They will have 10 to 120 ml (1/3 to 4 ounces) of blood drawn     from a vein in the arm. Blood samples may be taken on repeated occasions as long as the     relative remains in the study. The blood will be used for research that may involve     development of diagnostic tests for CVI, evaluation of the structure and function of normal     blood cells for comparison with those of patients with CVI, and studies to try to determine     possible genetic factors involved in susceptibility to CVI.   "
161691|NCT00001245|"     This study will explore faster and easier ways to detect infection with the intestinal     parasite Strongyloides stercoralis and learn more about the conditions under which it causes     serious disease. Ordinarily, the Strongyloides helminth (type of intestinal worm) causes only     few, if any, symptoms, but in people with weakened immunity it may be very serious, and even     deadly.      People between 5 and 80 years of age with known or suspected S. stercoralis infection, or     infection with another helminth, such as filariasis, that might cause a cross-reaction with     S. stercoralis may be eligible for this study.      Participants found to be infected with S. stercoralis will be treated with ivermectin,     thiabendazole, or albendazole. In addition, they will undergo the following tests and     procedures:        -  Blood tests and stool samples: Samples will be collected before and after treatment to          check general health status and immune function, and to look for parasites in stool. Up          to 50 milliliters (10 teaspoons) of blood will be drawn in adults and up to 25 ml (5          teaspoons) in children.        -  Skin tests: A test similar to those used for tuberculosis and allergies will be          conducted to determine if there is sensitization to products of the parasite. Such a          test might be used as a rapid method to diagnose the infection. About three drops of          several different antigens (proteins) are injected into the skin of the arm. After 15 to          20 minutes, the area is checked to see if a red spot has formed and, if so, the spot is          measured.   "
161692|NCT00001246|"     Magnetic Resonance Imaging (MRI) unlike X-rays and CT-scans does not use radiation to create     a picture. MRI use as the name implies, magnetism to create pictures with excellent     anatomical resolution. Functional MRIs are diagnostic tests that allow doctors to not only     view anatomy, but physiology and function. It is for these reasons that MRIs are excellent     methods for studying the brain.      In this study, researchers will use MRI to assess brain anatomy and function in X and Y     chromosome variation, healthy volunteers, and patients with a variety of childhood onset     psychiatric disorders. The disorders include attention deficit disorder, autism, congenital     adrenal hyperplasia, childhood-onset schizophrenia, dyslexia, obsessive compulsive disorder,     Sydenham's chorea, and Tourette's syndrome.      Results of the MRIs showing the anatomy of the brain and brain function will be compared     across age, sex (gender), and diagnostic groups. Correlations between brain and behavioral     measures will be examined for normal and clinical populations.   "
161693|NCT00001247|"     The purpose of this study is to understand the biologic basis of schizophrenia and to     determine which symptoms are related to the illness itself and which are related to     medications used to treat the illness.      Schizophrenia and related psychoses are chronic brain disorders whose prognosis is often poor     and whose pathophysiology remains obscure. Brain imaging technologies such s positron     emission tomography (PET), functional magnetic resonance imaging (fMRI), and magnetic     resonance imaging (MRI) offer opportunities to study the pathophysiology of psychotic     disorders by evaluating brain function. However, the use of anti-psychotic drugs may     interfere with the results of such studies. In this study, psychotropic medication will be     discontinued in patients for a short period of time to distinguish the effects of the illness     on the brain without the interference of the medication's effects on the brain. Given that     there is a risk that the patient's symptoms will increase, they are asked to stay on an     inpatient unit where the NIMH clinical staff is available to help them 24 hours a day.      This study will be conducted in three phases. In Phase 1, participants will be admitted to     the Clinical Center while continuing to take their medication and will undergo diagnostic     interviews, physical and laboratory assessments, physiological monitoring, and     neuropsychological testing. Behavioral ratings will also be performed and blood and urine     samples will be collected. During Phase 2, participants will continue taking medications in a     blinded fashion for 8 to 12 weeks. The active medications will be replaced with a placebo (an     inactive pill) part of that time. PET, fMRI, and MRI scans will be used to monitor how the     continuation or lack of medication affects the brain. Psychological tests will also be given     to measure changes in cognition. In Phase 3, participants will have the opportunity for     clinical stabilization.   "
161694|NCT00001248|"     Studies performed under 89-N-0045 are designed to examine the natural history of multiple     sclerosis (MS) using MRI and immunological measures. In addition to studying the natural     history of untreated patients, the natural history of patients receiving approved     disease-modifying therapies of MS will be examined. In both cohorts of patients levels of     disease activity on MRI will be compared with immunological characteristics in order to help     identify disease mechanism. Patients with either definite MS (based either on clinical or     combined clinical and MRI criteria) or with an initial presentation of neurological     dysfunction consistent with MS will be studied longitudinally by MRI. Disease activity on MRI     will be assessed using several MRI measures of disease activity including the number of     contrast enhancing lesions, the overall burden of disease, brain atrophy and measures to     assess axonal damage. Patients will be assessed clinically and correlations between     immunological and genetic factors and disease activity as seen clinically or by MRI will be     studied.      A second cohort of patients starting the use of approved therapy will also be examined.     Patients referred to NIH prior to beginning approved therapy will be assessed with a series     of three monthly MRIs to determine the level of pretreatment disease activity. After     beginning approved therapy under the direction of their private physician, patients will be     followed similarly to the natural history cohort. Immunological and genetic findings will be     accessed before and during therapy in order to help establish the mechanisms of action of the     therapies and to identify mechanisms accounting for either a response or lack of response to     therapy. Part of the collected samples willl be cryopreserved to provide respository for     further studies focusing on detection of biomarkers indicative of disease state, disease     stage or repsonse to therapies.      Additionally, a cohort of normal volunteers will be studied. The studies in the normal     volunteers will be used to establish the most appropriate imaging sequences for studying     normal white matter in MS patients using magnetization transfer (MT) imaging sequences for     studying normal white matter in MS patients using magnetization transfer (MT) imaging and to     provide normative immunological measures.   "
161695|NCT00001249|"     The study purpose is to evaluate the clinical response to multidose administration of     anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult     T-cell leukemia (ATL).   "
174921|NCT00131274|"     The purpose of the study is to evaluate the safety and efficacy of Gleevec (imatinib     mesylate) in the treatment of idiopathic pulmonary fibrosis (IPF).   "
161696|NCT00001250|"     Patients with untreated clinical stage II breast cancer are eligible. An excisional biopsy of     the primary tumor is acceptable, but without definitive local therapy or prior chemotherapy.     Histologic confirmation of invasive carcinoma is required. Patients are prospectively     randomized to receive five 21-day cycles of dose-intense (5-fluorouracil, adriamycin,     leucovorin, cytoxan, granuloctye-colony stimulating factor [FLAC/G-CSF]) chemotherapy either     before (preoperative) or after (postoperative) local therapy. Chemotherapy is given as an     outpatient. For patients receiving preoperative chemotherapy, local therapy (modified radical     mastectomy, or breast segmentectomy/axillary dissection/breast radiotherapy according to     patient preference) is performed 3-4 weeks after last chemotherapy. For patients receiving     postoperative chemotherapy, chemotherapy will begin 2-3 weeks after local therapy. Immediate     reconstruction for mastectomy is acceptable. Upon completion of local therapy and     chemotherapy in either treatment group, all estrogen receptor positive patients receive     tamoxifen for 5 years. Follow-up consists of history and physical examination each 3 months     for first 3 years, each six months for years 4 and 5, and yearly thereafter. Mammogram, bone     scan, chest x-ray and blood work are performed yearly.   "
161697|NCT00001251|"     The purpose of this study is to determine efficacy of intrathecal mafosfamide, a preactivated     derivative of cyclophosphamide against meningeal malignancies refractory to conventional     therapy (radiation therapy and chemotherapy). The maximally tolerated dose for intrathecal     mafosfamide will be established in a limited dosage escalation schedule. The CSF     pharmacokinetics of intrathecal mafosfamide will also be studied.      Mafosfamide will be administered intrathecally on a bi-weekly basis for four weeks, followed     by twice monthly administration for four months and then monthly IT administration. A minimum     of 9 patients will be studied in each disease category (leukemias, lymphomas, and other     malignancies refractory to conventional therapy).   "
161698|NCT00001252|"     This study will collect information on the different ways people control limb and body     movements. This information will be used to develop a database on normal movements and     adaptive movements of people who have diseases that affect the way they move. The database     will serve as a tool to improve diagnosis and treatment of patients with movement-related     problems.      Volunteers over the age of 4 who have normal movement patterns or who have developed     different ways to perform movement tasks may be eligible for this study. A physical therapist     will screen candidates to determine their strength, flexibility and range of motion of     joints.      Participants will be asked to perform movements such as walking, walking up or down stairs,     standing quietly or reaching for an object. For the test, the arms and legs are wrapped with     a soft, rubber-like material to which small plastic reflective balls are attached. A piece of     firm material called a shell may be attached to the rubber sleeves or other areas of the     body. Then the volunteer performs the specified task several times while special cameras     record the movement. The cameras only record the positions of the reflective balls during     movement, not the person s face or body. Electrical activity in the muscles also may be     measured, using small metal electrodes attached to the surface of the skin with an adhesive     bandage.   "
161699|NCT00001253|"     The development of the brain in females is a result of a combination of factors. During     puberty estrogen plays a role in influencing brain development. Cultural and environmental     factors also play a role in the development of the brain.      Female patients with Turner syndrome lack the ability to produce estrogen due to undeveloped     ovaries. Therefore, Turner syndrome is the perfect condition to study how estrogen (or the     lack of estrogen) influences a person's behavior and thinking.      This study will compare cognitive differences (visual motor skills, visual-spatial,     psychosocial behavior, and visual memory) of patients with Turner syndrome to normal patient     controls. Researchers will use the Weschler Intelligence Scale for Children-Revised (WISC-R)     along with other tests and scales to measure different aspects of the patient's cognitive     ability. In addition the study will review patients with Turner syndrome who previously     received estrogen replacement as infants and children in a related research study.      Researchers hope to demonstrate that estrogen replacement will improve cognition and behavior     in girls with Turner syndrome.   "
161700|NCT00001254|"     This protocol concerns the approach to the localization, diagnosis of MEN1 and management of     the tumor and the tissue samples in patients with Zollinger-Ellison syndrome. It details the     diagnostic imaging tests to be used to localize the tumor, investigations for MEN1 the     subsequent management of the tumor and tissue samples for research.   "
161773|NCT00000762|"     To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN     (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1     month to 18 years of age.      The initiation of this immunotherapy trial will provide multiple benefits by assessing in     asymptomatic HIV-infected children a therapy currently being tested in their adult     counterparts, in the hope of forestalling the progression of HIV immunosuppression and     clinical disease.   "
162436|NCT00002282|"     To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14     days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal     candidiasis in patients with AIDS.   "
161701|NCT00001255|"     This study will monitor the long-term effects of gene therapy in patients with severe     combined immunodeficiency disease (SCID) due to a deficiency in an enzyme called adenosine     deaminase (ADA). It will also follow the course of disease in children who are not receiving     gene therapy, but may have received enzyme replacement therapy with the drug PEG-ADA.      ADA is essential for the growth and proper functioning of infection-fighting white blood     cells called T and B lymphocytes. Patients who lack this enzyme are, therefore, immune     deficient and vulnerable to frequent infections. Injections of PEG-ADA may increase the     number of immune cells and reduce infections, but this enzyme replacement therapy is not a     definitive cure. In addition, patients may become resistant or allergic to the drug. Gene     therapy, in which a normal ADA gene is inserted into the patient's cells, attempts to     correcting the underlying cause of disease.      Patients with SCID due to ADA deficiency may be eligible for this study. Patients may or may     not have received enzyme replacement therapy or gene transfer therapy, or both. Participants     will have follow-up visits at the National Institutes of Health in Bethesda, Maryland, at     least once a year for a physical examination, blood tests, and possibly the following     additional procedures to evaluate immune function:        1. Bone marrow sampling - A small amount of marrow from the hip bone is drawn (aspirated)          through a needle. The procedure can be done under local anesthesia or light sedation.        2. Injection of small amounts of fluids into the arm to study if the patient's lymphocytes          respond normally.        3. Administration of vaccination shots.        4. Collection of white blood cells through apheresis - Whole blood is collected through a          needle placed in an arm vein. The blood circulates through a machine that separates it          into its components. The white cells are then removed, and the red cells, platelets and          plasma are returned to the body, either through the same needle used to draw the blood          or through a second needle placed in the other arm.        5. Blood drawings to obtain and study the patient's lymphocytes.   "
161702|NCT00001256|"     This study will evaluate the safety and effectiveness of prednisone and methotrexate in     treating severe Wegener's granulomatosis and other systemic vasculitides. These diseases     involve inflammation of blood vessels (vasculitis) that may affect the brain, nerves, eyes,     sinuses, lungs, kidneys, intestinal tract, skin, joints, heart and other sites. Current     treatment with prednisone and the anti-cancer drug cyclophosphamide is effective, but has     significant side effects and a high rate of disease recurrence. In a small number of patients     with vasculitis, prednisone and methotrexate, another anti-cancer drug, have led to marked     improvement, with fewer side effects than are seen with cyclophosphamide. This study will     evaluate this drug combination in a larger patient population.      Patients 10 to 80 years of age with active Wegener's granulomatosis, polyarteritis nodosa,     Churg-Strauss vasculitis, or microscopic polyangiitis overlap may be eligible for this 2 1/2     to 3-year study. In addition, patients with glomerulonephritis (a type of kidney disease) and     a positive blood test for C-ANCA (antibodies found in certain vasculitic kidney diseases) or     inflammatory sinusitis or lung nodule or infiltrates in the absence of infection may also be     enrolled.      Participants will take prednisone daily, by mouth, and low-dose methotrexate weekly, by mouth     or by injection either under the skin, into a muscle or into a vein. Patients who     significantly improve with treatment will gradually reduce, and eventually stop, the     prednisone. If the remission lasts, methotrexate will also be reduced and stopped after 2 1/2     years. If active disease recurs, the original treatment program may be started again.     Patients who never achieve complete remission with treatment but whose symptoms are well     controlled and experience no serious side effects may choose to either continue low-dose     methotrexate or stop therapy.      Patients will be hospitalized 4 to 6 times a year, about 2 to 8 days each time, depending on     their disease severity and response to illness. In addition, they will have the following     tests and procedures:        -  Medical history and physical examination (upon admission to the study and then every 1          to 3 months).        -  Blood tests for blood cell counts and for levels of enzymes that indicate liver damage          (upon admission, then weekly, and finally, no less than monthly).        -  Additional blood tests to measure blood chemistries and evaluate kidney function (upon          admission and again when clinically indicated).        -  Chest X-rays (upon admission and when clinically indicated).        -  Computerized tomography (CT) and magnetic resonance imaging (as needed).        -  Electrocardiogram (upon admission and then as clinically indicated).        -  Lung function studies (upon admission and at least every 6 months or as clinically          indicated).        -  Ear, nose and throat evaluations (as clinically indicated).        -  Liver biopsy, if blood tests to monitor liver function are persistently abnormal. This          procedure is done in the hospital under sedation to induce relaxation and drowsiness.          The skin over the liver (upper right abdomen) is numbed with a local anesthetic and a          needle is passed rapidly in and out of the liver to collect a small tissue sample for          microscopic examination.   "
161703|NCT00001257|"     This study will investigate the inflammatory response. People with abnormal regulation of     inflammation and immune defects often have an exaggerated or depressed inflammatory response     that results in poor healing of recurrent infections. This study will measure and compare     amounts of inflammatory mediators (chemicals involved in the inflammatory response) in     healthy normal volunteers and in patients with abnormal immune responses.      Healthy normal volunteers and patients with host defense defects or excessive inflammation,     as in vasculitis syndromes, may be eligible for this study. Patients must be between 6 and 65     years of age.      Participants will have eight small blisters raised on the forearm using a gentle suction     device. The top of the blisters will be removed with scissors and a plastic template will be     placed over the blisters. The wells of the template will be filled with a salt solution or a     mixture of the subject s serum (fluid part of the blood without cells) and a salt solution.     Some blisters may be covered with coverslips a small round piece of very thin sterilized     glass before adding the fluid. Blister fluid will be removed from the wells at 3, 5, 8, and     24 hours with a syringe and analyzed for inflammatory mediators. A scab will form over the     blisters and fall off in about 2 weeks.      Participants will have about 4 tablespoons of blood drawn in order to compare the     inflammatory mediators in the blood with those in the blister fluid.   "
161704|NCT00001258|"     The purpose of this study is to use brain imaging technology to investigate the role of the     frontal lobe of the brain in the thinking of individuals with schizophrenia and other     neuropsychiatric disorders and healthy volunteers.      Participants in this study will undergo a positron emission tomography (PET) scan of the     brain while performing neuropsychological tests. Some of the tests involve cognitive     operations that depend upon the frontal cortex. Interactions between frontal lobe activation,     cognitive behavior, and neuropharmacology will be assessed by measuring regional cerebral     blood flow (rCBF) during treatment with drugs that may affect frontal lobe physiology.   "
161705|NCT00001259|"     This study examines the effects of estrogen and progesterone on mood, the stress response,     and brain function and behavior in women with premenstrual syndrome.      Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to     be an effective treatment for PMS. The current purpose of this study is to evaluate how low     levels of estrogen and progesterone (that occur during treatment with leuprolide acetate)     compare to menstrual cycle levels of estrogen and progesterone (given during individual     months of hormone add-back) on a variety of physiologic measures (brain imaging, stress     testing, etc.) in women with PMS.      PMS is a condition characterized by changes in mood and behavior that occur during the second     phase of the normal menstrual cycle (luteal phase). This study will investigate possible     hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate     and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The     results of these hormonal studies will be compared between women with PMS and healthy     volunteers without PMS (see also protocol 92-M-0174).      At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy     tests will be performed. Cognitive functioning and stress response will be evaluated during     the study along with brain imaging and genetic studies.   "
161706|NCT00001260|"     The purpose of this study is to collect and study the brain tissue of deceased individuals to     learn more about the nervous system and mental disorders. Information gained from donated     tissue may lead to better treatments and potential cures for nervous system and mental     disorders.      This study will ask relatives of deceased individuals to donate the brains of their deceased     relatives to allow further study of neurological and psychiatric disorders. We do not accept     prospective donations.   "
161707|NCT00001261|"     Inflammatory myopathies are a group of muscle diseases characterized by muscle weakness, high     levels of muscle enzymes in the blood, and inflammation of the tissue surrounding muscle     fibers (endomysium).      The diseases making up the inflammatory myopathies are grouped into three subsets:      I) Polymyositis (PM)      II) Dermatomyositis (DM)      III) Inclusion Body Myositis (IBM)      Inflammatory myopathies are thought to be autoimmune processes and are treated with steroids     and immunosuppressive drugs. However, many patients who initially respond to these treatments     develop resistance to the therapy or experience side effects causing the treatments to be     stopped.      Researchers believe that intravenous immunoglobulin (IVIg) may provide patients with PM, DM,     and IBM a safer and more effective alternative to standard therapies for the diseases. IVIg     is a drug that has been used successfully to treat other immune-related diseases of the     nervous system.      The study will take 60 patients and divide them into two groups. Group one will receive 2     injections of IVIg once a month for three months. Group two will receive 2 injections of     placebo inactive injection of sterile water once a month for three months. Following the     three months of treatment, group one will begin taking the placebo and group two will begin     taking IVIg for an additional 3 months. The drug will be considered effective if patients     receiving it experience a significant improvement (>15%) in muscle strength.   "
162285|NCT00002155|"     To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine     (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan )     plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.   "
161718|NCT00001277|"     Patients whose parathyroid activity is elevated above normal are referred to as having     hyperparathyroidism. This study will help researchers better understand the causes of     hyperthyroidism and to evaluate and improve methods for diagnosis and treatment.      In this study, patients diagnosed with or suspected of having hyperparathyroidism will be     selected to participate. In addition, patients with related conditions such as parathyroid     tumors, will also be selected.      Subjects will be asked to provide blood and urine for testing to confirm their condition.     They will then be surgically treated by removal of the parathyroid gland(s)     (parathyroidectomy).      Subjects with parathyroid tumors will undergo several diagnostic tests to determine the exact     location of the tumor as well as the tumor's activity. The tests may include; ultrasounds,     nuclear scanning, CT scans, MRI, and specialized blood testing.      Sometimes parathyroidectomy leads to hypoparathyroidism. Options for treating the patients     after the surgical procedure will also be addressed. Calcium and Vitamin D supplements are     typically the mainstay of post parathyroidectomy therapy. Other potential treatments include     transplanting the parathyroid gland(s) to other areas of the body.   "
175733|NCT00142610|"     This study will determine if airway antioxidant levels in allergic asthmatics are enhanced     with a combination of vitamin E and vitamin C therapy.   "
161708|NCT00001262|"     Menkes Disease is a genetic disorder affecting the metabolism of copper. Patient with this     disease are both physically and mentally retarded. Menkes disease is usually first detected     in the first 2-3 months of life. Infant males born with the disease fail to thrive,     experience hypothermia, have delayed development, and experience seizures. These infants also     have characteristic physical features such as changes of their hair and face. Females may     also have changes in hair and skin color, but rarely have significant medical problems.      Appropriate treatment of Menkes Disease requires that the disease be diagnosed early and     treatment started before irreversible brain damage occurs. The aim of treatment is to bypass     the normal route of absorption of copper through the gastrointestinal tract. Copper must then     be delivered to brain cells and be available for use by enzymes.      Copper histidine is a copper replacement that can be injected directly into the body to avoid     absorption through the gastrointestinal tract. However, studies have shown the genetic     abnormalities causing Menkes disease cannot simply be corrected by copper replacement     injections.      The genetic abnormality causing Menkes disease can vary in its severity. Patients with a     genetic abnormality that may still permit some production of the enzymes required to process     copper may receive benefit from early treatment with copper replacement. However, patients     with severe abnormalities of the genes responsible for copper metabolism may receive no     benefit from copper replacement.      The purpose of this study is to continue to evaluate the effects of early copper histidine in     Menkes disease patients and to correlate specific molecular defects with responses to     treatment.   "
161709|NCT00001265|"     This study of inflammatory muscle diseases-polymyositis and dermatomyositis and related     disorders-will examine what causes these diseases and describe the clinical features (signs     and symptoms) associated with them. Inflammation and degeneration of skeletal muscles in     these disorders leads to weakness and muscle wasting. The skin, lungs and other organs may     also be involved.      Patients 16 years of age and older with polymyositis, dermatomyositis, or a related disorder     may be eligible for this study. Participants will undergo a complete history and physical     examination, including routine blood and urine tests. Additional procedures for diagnosis,     treatment or research may include:        1. Blood sample for genetic studies.        2. Muscle biopsy-removal of a tissue sample for microscopic examination. Under local          anesthetic, a 1/2- to 1-inch long incision is made in the thigh or upper arm, and a          small piece of muscle is removed.        3. Electromyography-measurement of the electrical activity of a muscle. A needle is          inserted through the skin into a muscle to record its electrical activity.        4. Magnetic resonance imaging-visualization of organs or tissues, using a magnetic field          and radio waves. The patient lies on a table inside a narrow cylinder (the MRI scanner)          with a strong magnetic field for the scanning.        5. Manual muscle strength testing by a physiotherapist.        6. Swallowing studies using ultrasound (imaging using sound waves) and X-rays (barium          swallow) to evaluate swallowing and speaking abilities.        7. Questionnaires on swallowing ability and ability to perform daily living activities        8. Pulmonary function tests-measurement of movement of air in and out of the lungs. The          patient breathes into a machine to evaluate lung function.        9. Chest X-rays to evaluate lung function.       10. Electrocardiogram and, if necessary, Holter monitoring (measurement of the electrical          activity of the heart) and echocardiogram (ultrasound imaging of the heart) to evaluate          heart function.       11. Apheresis-collection of white blood cells for research. Whole blood is collected through          a needle placed in an arm vein. The blood circulates through a machine that separates it          into its components. The white cells are removed and the rest of the blood is returned          to the body through the same needle or through a second one placed in the other arm.       12. MR guided muscle biopsy-measurement of glycogen in muscle tissue using magnetic          resonance imaging. Certain patients may undergo this experimental procedure to compare          MRI findings with those of muscle biopsy. The affected muscles are identified using MRI          and the biopsy incision is made. MRI is then used to guide the biopsy needle to the          muscle and a small piece is removed.      Patients who are eligible for experimental treatment studies will be offered the opportunity     to join them. Others will be advised of treatment recommendations.   "
161710|NCT00001266|"     One current hypothesis as to what limits duration of initial hormone response is the rapid     emergence of hormone resistant prostate carcinoma cells. Suramin has shown effectiveness as a     treatment for hormonally refractory prostate carcinoma. Survival was less in patients with     high rather than low circulating androgen levels. Thus, suramin might slow the emergence of     hormone refractory tumor cells while combined androgen ablation may maximize the     effectiveness of suramin. In this trial, we will pilot this concept.   "
161711|NCT00001267|"     Several dideoxynucleosides have now been shown to have activity against HIV but to have     different toxicities. This study will involve therapy of patients with AIDS or ARC with two     of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles,     over a 2-year period of time. The rationale for using the two drugs will be to reduce     toxicity and also possibly to delay or prevent the development of resistance. Patients will     be randomized to receive either an alternating regimen or a continuous simultaneous regimen     with these two drugs. The study will be structured as a randomized pilot study.   "
161712|NCT00001269|"     This is a phase I study to determine the maximal tolerated dose of IL-3 given alone or     sequentially with GM-CSF following FLAC chemotherapy in metastatic breast cancer patients.   "
161713|NCT00001270|"     This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with     autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid     cancers. The initial goal of this study was to define the toxicity of interleukin-1     administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated     with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second     cohort of 18 patients also received G-CSF and engraftment was further shortened in some     subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF.     Accrual will continue to further define the toxicity and efficacy of this regimen.   "
161714|NCT00001271|"     Patients with CD22(+) B-cell lymphomas will be treated with escalating doses as a 192 hr     infusion of immunotoxin in a Phase I study to determine dose limiting toxicity evidence of     response.   "
161715|NCT00001272|"     This is a Phase I study which addresses the feasibility and toxicity of adding taxol to the     two drug combination which now comprises the standard of care in newly diagnosed advanced     stage ovarian cancer, cisplatin and cyclophosphamide. These drugs will be given in a dose     intensive fashion with the colony-stimulating factor, G-CSF. Newly diagnosed patients with     ovarian cancer will be treated with this regimen to determine the optimal dose of this     combination. The pharmacokinetics of taxol and cisplatin DNA-adducts will be studied as well.   "
161716|NCT00001275|"     No proven therapy to restore ovarian function and fertility is available to patients with     karyotypically normal spontaneous premature ovarian failure. We know that one-half of these     patients have primordial follicles remaining in the ovary, and these follicles can function     intermittently. This is a diagnostic omnibus protocol that permits baseline clinical     evaluation of patients with prematurem ovarian failure. The findings will determine patients'     suitability for specifically focused therapeutic research protocols.   "
162286|NCT00002156|"     To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an     additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV)     retinitis.   "
161719|NCT00001278|"     The purpose of this study is to develop a relatively simple, accurate method of diagnosing     sarcoidosis. Sarcoidosis is a disease in which granulomas (nodules of inflamed tissue)     develop in various organs, such as the lungs, liver, skin and eyes. Disease symptoms vary     depending on the tissues involved. Many patients develop uveitis (eye inflammation). Tissue     biopsy-often a costly and difficult invasive procedure-is currently the only definitive     diagnostic test for sarcoidosis. Other tests, such as blood and urine tests, do not provide     definitive results.      Patients with uveitis that is 1) known to be due to sarcoidosis; 2) suspected to be due to     sarcoidosis based on specific diagnostic criteria; and 3) known not to be due to sarcoidosis     may be enrolled in this study. Participants will undergo an eye examination, blood tests,     chest X-ray, and skin test for tuberculosis and other infections. Small tissue samples from     the conjunctiva (the thin lining covering the outside of the eye and the inside of the     eyelid) and the lacrimal (tear) gland will be taken after the eye is numbed with anesthetic     drops and injection.      Investigators will examine and compare levels of certain proteins in the biopsied tissues     from the three patient groups to see if elevated levels of these substances may indicate     granuloma formation. Development of a new, relatively simple diagnostic test for sarcoidosis     based on these findings may permit doctors to start appropriate therapy earlier in the course     of disease without invasive biopsy.   "
161720|NCT00001280|"     This protocol describes a prospective, randomized study examining the safety and efficacy of     Itraconazole for preventing fungal infections in patients with Chronic Granulomatous Disease     (CGD). CGD is a genetic disorder in which phagocytes are unable to produce oxygen radicals.     As a result, affected patients are prone to recurrent, severe infections with bacterial and     fungal organisms. Patients with CGD of 5 or more years of age without evidence of infection     at the time of study entry will be eligible for enrollment. Patients will be randomized to     receive itraconazole or placebo tablets daily, in a double blinded fashion. In addition to     itraconazole, all patients will receive antimicrobial prophylaxis against bacterial     infection, and may in addition receive gamma-interferon as prophylaxis against infection.     Randomization of patients will be stratified among patients receiving or not receiving gamma     interferon. The primary endpoint of the study will be the development of culture or     histologically proved invasive fungal disease. Patients will be monitored every three months     for evidence of drug toxicity. The anticipated accrual period will be approximately 36-48     months.   "
161721|NCT00001281|"     This study will examine the effects of HIV infection on substances produced by immune cells     that increase or decrease HIV infection.      HIV-infected patients and healthy normal volunteers may be eligible for this study.     Participants will be required to have a yearly medical evaluation, including blood tests for     cell counts and chemistries, a blood or urine pregnancy test for women, and other laboratory     tests as medically indicated or for research purposes.      Participants will donate blood or reproductive fluids, or both. From 20 to 150 cc (4 to 30     teaspoonfuls) of blood will be drawn from the arm using a small needle. Participants may be     asked to provide blood samples on more than one occasion over the course of the study. No     more than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period. Males     will be given a private room for semen donation; fluid from females will be collected with a     cotton swab after speculum insertion. Participants may also be asked to have a buccal swab.     For this procedure, the inside of the cheek is gently scraped with a blunt-ended stick or     brush to obtain cells (buccal mucosal cells). The tissues will be used for a variety of     studies on the effects of HIV infection on factors that increase or decrease HIV infection.      Some of the tissues collected for this study may also be used for the following tests:        -  Hepatitis screening Blood may be screened for different types of viral liver infections,          such as hepatitis A, B, C, D, E, or G.        -  Genetic testing DNA from blood or cheek cells may be examined for mutations or deletions          that affect chemokines, cytokines and a family of enzymes called caspases. Chemokines          and cytokines are important mediators of the immune response. Alterations in the genes          for some of these substances influence HIV infection. Caspases regulate the process of          cell death, known as apoptosis. Caspase gene variations may determine the rate of cell          death in HIV-infected persons, and therefore, the rate of HIV progression. Patients with          abnormalities of any of these genes may be invited to join other studies of the role of          genetic defects in HIV infection.        -  HLA testing Blood may be tested for HLA type a genetic marker of the immune system.          These tests may be used to try to identify factors associated with the rate of          progression of HIV disease or related conditions. Determining HLA type is necessary to          be able to perform certain research studies. Some HLA types have been associated with an          increased risk of certain diseases like arthritis and other rheumatologic problems.   "
161722|NCT00001282|"     This study will evaluate the long-term toxicity and obtain preliminary information about     long-term efficacy of the combination of antiretroviral therapies and interleukin-2 (IL-2), a     cytokine with immunomodulatory properties. Currently 73 patients have been approved to     receive IL-2 at a starting dose of 18 MIU/d for 5 days. Multiple courses of IL-2 will be     administered, at approximately 2 month intervals. Clinical, laboratory, immunologic, and     viral parameters will be closely monitored during this time for evidence of toxicity and     preliminary evidence of efficacy.   "
161723|NCT00001284|"     The purpose of this study is to use brain imaging technology to compare differences in brain     structure, chemistry, and functioning in individuals with brain and mental disorders compared     to healthy volunteers.      Schizophrenia is a brain disorder that results from subtle changes and abnormalities in     neurons. These deficits likely occur in localized regions of the brain and may result in     widespread, devastating consequences. The neuronal abnormalities are inherited through a     complex combination of genetic and environmental factors. Brain imaging technologies can be     used to better characterize brain changes in individuals with schizophrenia. This study will     use magnetic resonance imaging (MRI) scans to identify predictable, quantifiable     abnormalities in neurophysiology, neurochemistry and neuroanatomy that characterize     schizophrenia and other neurological and neuropsychiatric disorders.   "
164944|NCT00004467|"     OBJECTIVES:      I. Determine the safety and efficacy of a short course (72 hours) of intravenous     acetylcysteine in patients with acute liver failure for whom no antidote or specific     treatment is available.   "
161743|NCT00001309|"     Pharmacokinetics is the term used for how the body affects a drug once it is taken. Vitamin     C, also known as ascorbic acid, is an essential water soluble vitamin. Meaning, the body does     not make Vitamin C it must be taken in through the diet. In this study researchers will     attempt to determine how the amount of water consumed affects the level of vitamin C in the     blood (specifically the plasma component of the blood).      In this study researchers will take 13 subjects and place them on a Vitamin C restricted     diet. Vitamin C levels will be measured twice a week on an outpatient basis until all     subjects reach a desired low level of Vitamin C (12-15 micromolar plasma ascorbic acid     concentration). Subjects will then be admitted and undergo 24 hour blood and urine     collection. Following the collection of samples, subjects will then begin to receive Vitamin     C orally (by mouth) and intravenously (injected into the vein). The dosage of Vitamin C will     gradually increase from 30 mg-2500 mg divided into two daily doses. Blood and urine samples     will be collected each time the dose is increased. The study will take approximately 18 weeks     after which the subjects will be discharged in healthy condition.   "
161724|NCT00001285|"     For many years researchers have been trying to better understand the regulation of sleep and     activity by studying circadian (daily) rhythms of human beings. It appears that the hormones     estrogen, progesterone, and testosterone play a role in the regulation of circadian rhythm in     animals. Researchers believe these hormones may also play a similar role in the regulation of     human circadian rhythms. Little research has been conducted on how these hormones affect     human circadian rhythms.      This study is designed to learn more about how specific hormones influence men and women's     daily rhythms. This study will use women from another research study being conducted at the     NIMH called, The central nervous system effects of pharmacologically induced     hypogonadotropic hypogonadism with and without estrogen and progesterone. Male subjects will     be recruited from another NIMH study called, The central nervous system effects of     pharmacologically induced hypogonadotropic hypogonadism with and without testosterone     replacement.      In order to test the possibility that gonadal steroids (estrogen, progesterone, and     testosterone) change circadian rhythms and the sleep-wake cycle in humans, participants will     undergo chronobiologic evaluations. The chronobiologic evaluations will look at sleep and     rest periods, activity as measured by a wrist monitor, and 24 hour inpatient     electroencephalograph (EEG), rectal temperature, and melatonin monitoring.   "
161725|NCT00001287|"     Chronic Inflammatory Demylinating Polyneuropathy (CIDP) is an autoimmune condition affecting     the nervous system. Researchers believe the immune system begins attacking the cells covering     nerves called myelin. The destruction of myelin causes muscle weakness, loss of sensation,     abnormal levels of protein in the fluid surrounding the brain (CSF), and slowing of the     nervous system. The disease progresses slowly and disables patients suffering from it.      CIDP is treated with steroids, plasmapheresis, and immunosuppressive drugs. Many patients     initially respond to these treatments, but develop resistance to the therapy or experience     side effects causing the treatments to be stopped.      Researchers believe that intravenous immunoglobulin (IVIg) may provide patients with CIDP a     safer and more effective alternative to standard therapies for the disease. IVIg is a drug     that has been used successfully to treat other immune-related diseases of the nervous system.     However, because IVIg is so expensive, researchers believe it should first be proven     effective on a small group of patients.      The study will take 60 patients with CIDP and divide them into two groups. Group one will     receive 2 injections of IVIg once a month for three months. Group two will receive 2     injections of placebo inactive injection of sterile water once a month for three months.     Following the three months of treatment, group one will begin taking the placebo and group     two will begin taking IVIg for an additional 3 months. The drug will be considered effective     if patients receiving it experience a significant improvement (>25%) in muscle strength.   "
161726|NCT00001288|"     Positron Emission Tomography (PET) is a technique used to investigate the functional activity     of the brain. The PET technique allows doctors to study the normal processes of the brain     (central nervous system) of normal individuals and patients with neurologic illnesses without     physical / structural damage to the brain.      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and     water. Blood carries fuel to the brain and waste products away from the brain. As brain     activity increases blood flow to and from the area of activity increases also. Knowing these     facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of     the brain are receiving more blood flow.      This study is designed to use positron emission tomography (PET) with radioactive water     (H215O) to determine the areas of the brain associated with memory and language. Patients     participating in the study will be made up of normal volunteers, patients with epilepsy, and     patients with other abnormalities related to the surface of the brain (non-epileptic focal     cortical dysfunctions).   "
161727|NCT00001289|"     Gaucher disease is a lysosomal storage disease resulting from glycocerebroside accumulation     in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in     adults but occurs most severely in infants, in whom cerebroside also accumulates in neurons.     Patients with Gaucher's disease experience enlargement of the liver and spleen and bone     destruction. The condition is passed from generation to generation through autosomal     recessive inheritance. There are actually three types of Gaucher's disease.      Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease     does not affect nerve cells. The symptoms of type I can appear at any age.      Type II appears in infancy and usually results in death for the patient. Type II is an acute     neuronopathic form and can affect the brain stem. It is the most severe form of the disease.      Type III is also neuronopathic, however it is subacute in nature. This means the course of     the illness lies somewhere between long-term (chronic) and short-term (acute).      The purpose of this study is to examine the effects of enzyme replacement therapy on patients     with Gaucher's disease, specifically those types directly affecting the nervous system     (neuronopathic).      Patients with Gaucher's disease types II and III will be selected to participate in the study     and receive enzyme replacement therapy. Patients participating will undergo a variety of     tests to measure levels of hemoglobin concentration, liver volume, and spleen volume.     Improvements in these measures will be compared other laboratory tests measuring the     involvement of the nervous system.   "
161735|NCT00001301|"     Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during     which time a number of different treatment protocols have been used. Approximately 110     patients have apparently been cured of their lymphoma. The present protocol has no     therapeutic component, but is designed to document the late effects that may have been     encountered by our patients, either as a consequence of the disease or its treatment. In     essence, patients who consent to participate will be asked a series of questions pertaining     to the quality of their life and possible medical problems that they may be encountering. In     addition, they will receive a complete physical examination and undergo non-invasive     investigations designed to identify the presence of unsuspected late effects. Investigators     in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will     participate in the protocol. As a part of the study, blood samples will be obtained to     investigate the possibility that predisposing genetic factors may be identifiable in the     patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such     abnormalities are detected, blood samples from family members will also be examined to     determine whether the defect was inherited.   "
161728|NCT00001291|"     This protocol will examine blood, synovial fluid and synovial tissue from patients with     rheumatoid arthritis and other chronic inflammatory joint diseases to study genetic and     immunologic factors involved in the cause, development and progression of these conditions.     Synovial fluid is the lubricating fluid in joints. The synovial membrane is a delicate tissue     lining the inner surface of joints, which, in arthritic conditions, thickens and becomes     infiltrated with various types of cells.      Patients with rheumatoid arthritis and certain patients with other forms of arthritis may be     eligible for this study. Those enrolled will be followed periodically for follow-up and     disease evaluation. They may undergo the following procedures:        1. Synovial fluid aspiration, when medically indicated (for example, for joint swelling and          inflammation). For this procedure, an area of skin around the joint is numbed with an          anesthetic, and a needle is inserted into the joint to withdraw a small fluid sample.        2. Periodic blood sampling, not to exceed 450 milliliters (15 ounces) during any 6-week          period, for genetic studies of rheumatoid arthritis. The samples are usually taken at          the same times that synovial fluid is withdrawn.        3. Synovial tissues, collected by needle biopsy or during surgical procedures for          arthroscopy (examination of the interior of the joint and repair of the joint) or total          joint replacement. For the needle biopsy, the skin over the biopsy site is washed and          anesthetized. A needle is inserted and fluid is aspirated. The biopsy needle is then          inserted through the outer needle and a tissue sample is suctioned.      Patients who qualify for other research studies may be invited to participate.   "
161729|NCT00001292|"     The purpose of this study is to identify the genes responsible for certain scaling disorders     and other inherited skin diseases and to learn about the medical problems they cause. In some     cases, these may include problems affecting organs other than the skin, such as the eyes,     teeth and bones.      Patients with inherited skin disorders, including Darier's disease (keratosis follicularis),     lamellar ichthyosis, epidermolysis bullosa, cystic acne, and others, and their relatives may     be eligible for this study. Patients will have a medical history, physical examination with     particular emphasis on the skin, and routine blood tests. Additional procedures for patients     and unaffected relatives may include:        1. Blood sample collection        2. Dental exam with X-ray of the jaw        3. Eye examination        4. X-rays of the skull, ribs, chest, hands, feet, spine, arms, or legs        5. Bone density scan        6. Photographs of the skin        7. Skin biopsies (removal of a small tissue sample under local anesthetic)        8. Buccal sample (gentle brushing inside the cheek to collect a cell sample) for gene          studies      Patients who request the results of their gene testing will be provided this information.   "
161730|NCT00001294|"     We propose to test, by DNA linkage analysis of family pedigree members, the following     interrelated hypotheses: 1) that sexual orientation is genetically influenced; 2) that the     development of Kaposi's sarcoma and other outcomes of HIV infection in male homosexuals is     affected by host susceptibility genes, circulating sex hormone levels, or HLA haplotype; and     3) that alcoholism and other psychobehavioral conditions are associated with homosexuality on     a genetic basis and/or influenced by candidate behavioral loci. The subjects for these     studies will be self-identified male and female homosexual probands and their relatives from     families in which there are at least two individuals with homosexual orientation. All     subjects will be adults, and will be referred through NIH physicians, private practitioners,     and gay and lesbian organizations. Subjects will undergo a sexual orientation and behaviors     interview, a psychiatric interview, and phlebotomy for HIV testing, HLA determination,     endocrine measurements, and preparation of DNA from cultured lymphocytes. The DNA samples     will be analyzed for a series of genetic markers that span the human genome and for candidate     loci chosen for function.   "
161731|NCT00001295|"     This protocol is to provide continuing medical/surgical/radio-therapeutic care, treatment and     follow-up for NCI patients not currently entered on an active research protocol. No     investigational treatments will be administered on this protocol.   "
161732|NCT00001296|"     Randomized study. Initially, 3 patients will be entered on Arm I as a pilot feasibility study     and to standardize the technical aspects of the study. Subsequently, all patients are     randomized to Arms I and II.      Arm I: Regional Hyperthermia plus Regional Single-Agent Chemotherapy. Hyperthermic     intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806.      Arm II: Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response     Modifier Therapy. HILP as in Arm I; plus L-PAM; and Tumor Necrosis Factor (Knoll), TNF,     NSC-635257; Interferon gamma (Genentech), IFN-G, NSC-600662.   "
161733|NCT00001298|"     High dose methotrexate with leucovorin rescue has demonstrated activity in numerous     malignancies. Although high dose methotrexate is generally well tolerated, unpredictable     life-threatening toxicity can occur. For patients who have markedly delayed clearance of     methotrexate secondary to renal dysfunction, therapeutic options are few and are of limited     efficacy. Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal     glutamate residue. Carboxypeptidase-G2 could be used to rescue patients with renal     dysfunction and delayed methotrexate excretion, as it provides an alternative to renal     clearance as a route of elimination.   "
161734|NCT00001300|"     Randomized study. All patients must be randomized to treatment on Arms I and II within 3     months of definitive surgery on Regimen A.      Regimen A: Surgery followed, as indicated, by Radiotherapy. Amputation; or limb-sparing     resection followed by involved-field irradiation using megavoltage equipment with or without     electron boost.      Arm I: 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation and Urothelial     Protection. Doxorubicin, DOX, NSC-123127; Ifosfamide, IFF, NSC-109724; with Granulocyte     Colony Stimulating Factor (Amgen), G-CSF,      NSC-614629; and Mesna, NSC-113891.      Arm II: Observation. No adjuvant chemotherapy.   "
161754|NCT00001323|"     The purpose of this study is to evaluate the cognitive processes of participants with     schizophrenia, participants with nervous system and mental disorders, and healthy volunteers.      Participants in this study will undergo cognitive tests of attention, memory, attention.     Participants with attention deficit hyperactivity disorder (ADHD), traumatic brain injury     (TBI), bipolar disorder, and Alzheimer's disease (AD) will be compared with participants with     schizophrenia. A group of healthy adults and children will undergo cognitive tests to further     delineate the degree of impairment in schizophrenia and neurological disorder participants.   "
194190|NCT00387738|"     The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe     and effective in reducing the symptoms of ragweed allergy.   "
161736|NCT00001302|"     The clinical study entitled A Phase I Study of Infusional Chemotherapy with the     P-glycoprotein Antagonist PSC 833 seeks to determine the maximum tolerated dose for a     proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is     purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in-vitro studies     to enhance chemosensitivity as well as cyclosporine and to be far better at increasing     intracellular drug accumulation than the concentrations of verapamil which are clinically     achievable. The purpose of this study is to define the maximum tolerated dose in combination     with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine.     PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent     compound, cyclosporine. This effect will increase the area under the curve (AUC) of     vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a     conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8     days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This     first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent     cycles both agents will be combined. Escalation of the PSC 833 will continue until a target     concentration is reached, or until the maximum tolerated dose is reached. Clinical responses     will be monitored in order to provide the best possible medical care to our patients.   "
161737|NCT00001303|"     Bacterial infections can progress to a life-threatening illness called septic shock,     characterized by low blood pressure and vital organ damage. The syndrome is thought to be     caused by parts of the bacteria and by the body s own immune response to the infection. A     major bacterial product that interacts with the immune defenses is called endotoxin. This     study will examine the body s response to endotoxin in the lungs or bloodstream. When     endotoxin is given in small amounts to humans, even though it is not an infection, it     triggers a set of responses that are typical of what one would see with a true bacterial     infection. This allows us to study the earliest changes in molecules and cells that are     involved in some bacterial infections. This type of model is safe and has been used in humans     for many years to understand the body s responses during infections.      Normal volunteers 18 to 45 years of age may be eligible for this study. Candidates will have     a history and physical examination, blood and urine tests, electrocardiogram (EKG) and chest     X-ray. In addition, volunteers 40 to 45 years old will have an exercise stress test to screen     for asymptomatic coronary artery disease. Participants will undergo one or more of the     following procedures:      Bronchoscopy, Bronchoalveolar Lavage, Bronchial Brushings, and Endobronchial Mucosal     Biopsies: These techniques for examining lung function are used routinely in patient care and     clinical research. The mouth and nasal and lung airways are numbed with an anesthetic. A     bronchoscope (pencil-thin flexible tube) is then passed through the nose into the large     airways of the lung. Cells and secretions from the airways are rinsed with salt water     (bronchoalveolar lavage) and a flexible brush the size of a pencil tip is passed through the     bronchoscope to scrape cells lining the airways. Lastly, pieces of tissue (the size of the     ball of a ballpoint pen) lining the airways are removed for examination under the microscope.      Intravenous Endotoxin: A small dose of endotoxin is injected into a vein. Blood samples are     drawn at regular intervals for 8 hours after the injection and again after 1, 2, 3, 7 and 14     days to analyze the body s immune response to the bacteria in the blood.      Instilled Endotoxin in the Lungs: A small amount (2 teaspoons) of salt water is squirted     through a bronchoscope into a lobe of one lung, and then salt water containing a small dose     of endotoxin is squirted into the other lung. Bronchial lavage, brushing, and biopsy (see     above) are then done to study the response of the lung to the endotoxin. In addition, air is     withdrawn through the bronchoscope to study air components from the lung that was instilled     with salt water or endotoxin.      Nitric Oxide Therapy: Endotoxin is instilled in a lung (see above) and then nitric oxide a     colorless, odorless, tasteless gas mixed with room air in a concentration of 40 parts per     million, is given through a cushioned mask placed over the mouth and nose. (Some participants     will be given the nitric oxide mixture and others will breathe only room air through the mask     to test the effects of the nitric oxide on the lung inflammation.) The mask will be worn     continuously for 6 hours and removed before repeat bronchoscopy with lavage, brushing and     biopsy.      Some of the above procedures require placement of a catheter (thin plastic tube) in a wrist     artery to monitor blood pressure from heartbeat to heartbeat and to collect blood samples.     First, the skin is numbed with an anesthetic (lidocaine). A needle is then inserted into the     artery, the catheter is slipped over the needle into the vessel, and the needle is removed.   "
161738|NCT00001304|"     This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH)     as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with     calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients     who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism     to be managed effectively with the investigational drug, PTH. The primary goals of this study     are to (1) provide long-term PTH therapy to patients who do not respond to conventional     therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney     function and bone mineral density; (3) study and track linear growth and bone accrual in     children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone     mass and if the timing of this is comparable to normal age-matched healthy controls.   "
161739|NCT00001305|"     Growth deficiency is a key feature of severe Osteogenesis Imperfecta (OI) and a frequent     feature of mild to moderate forms of the disease. The reason that children with OI are short     is not fully understood. We do know that details such as the number of fractures suffered or     the type of OI do not fully explain the short stature of OI. Growth patterns have been     defined for children with OI Types I, III, and IV. At about 12 months of age, children with     Types III and IV OI demonstrate a predictable plateau of their linear growth rate. Type IV OI     children begin to resume a normal growth rate at about age four to five years, but they will     not catch up to a normal height, as they have lost a significant period of growth. The     plateau usually continues for children with Type III OI. The reason for this growth plateau     is unknown. There have been no studies which evaluate the growth of OI children in this age     range. Our previous studies of growth in OI children have begun at age 5 years.      We have studied growth in OI children for the past 10 years. Different medications have been     tried to both stimulate growth and improve bone density. Some children have responded to     growth hormone (their growth rate increased by at least 50%) and some did not. The majority     of children who did respond were Type IV. However, we need to carefully treat and study more     children to try to determine which children will benefit from growth hormone medication.      The Goals of this Study Are:        1. We want to try to find a cause for the growth plateau common in types III and IV OI.          Long-term, our goal is to develop a treatment to eliminate this plateau.        2. We want to see how long and how well OI bone will respond to growth stimulation.        3. We hope to find a predictor for who will respond to growth hormone and who will not,          by measuring your child's endocrine and growth hormone function before receiving any          growth hormone treatment.        4. We want to measure the effects of growth stimulation on bone density, and the quality of          OI bone.        5. We want to see if there are long term benefits resulting from this treatment in the form          of final adult height, trunk height, and possibly improved function of the respiratory          system.      Median Subject Age (on p. 1 of webpage): 1-15 years (replaces 0-20)   "
161740|NCT00001306|"     No therapy for infertile patients with premature ovarian failure has been proven effective.     Some anecdotal reports have suggested that high dose, long term prednisone (steroid) therapy     may be useful in treating autoimmune ovarian failure. However, prednisone, when used in     high-doses for long periods of time has substantial side effects, including aseptic necrosis     of bone where portions of bone die without the presence of infection and are surrounded by     healthy tissue. Aseptic necrosis of bone often requires major surgical treatment. Even with     this known level of risk, patients with premature ovarian failure are being treated based on     this anecdotal evidence.      This study will test the hypothesis that a lower risk therapy (alternate-day, lower dose,     shorter-term prednisone) will cause a remission of autoimmune ovarian failure. There is no     reliable blood test to identify patients who have premature ovarian failure. Therefore, all     patients must undergo a laparoscopic ovarian biopsy to confirm the presence of an auto immune     reaction in the ovaries (autoimmune oophoritis). Laparoscopy is a surgical procedure that     allows doctors to explore the abdomen using a camera-like device called a laparoscope. The     procedure has been used clinically by some reproductive endocrinologists to identify patients     with premature ovarian failure who have an autoimmune mechanism for the disorder.      The treatment will be deemed successful based on the return of ovulation as determined by     weekly serum progesterone levels.   "
161741|NCT00001307|"     This study will examine how the brain processes pain signals and how the different parts of     the brain work with each other in response to painful stimuli. A better understanding of how     people experience pain may be helpful in developing more effective treatments.      Healthy normal volunteers, patients requiring third molar (wisdom tooth) extraction, and     patients with persistent pain due to disease, injury or other reason may be eligible for this     study.      Participants will receive one or more of the following sensory stimuli, which may cause brief     discomfort or pain:        -  Heat/Cold - applied by an electronically controlled device that touches the skin, or by          temperature-controlled water baths, or by a thermally controlled brass cylinder the          subject grasps        -  Capsaicin (active ingredient in hot chili peppers) - injected in a small volume of fluid          under the skin or into a muscle        -  Mechanical stimulation - brushings or vibrations that do not normally cause pain        -  Ischemic stimulation - inflation of a blood pressure cuff on the arm or leg for up to 30          minutes      These stimuli will be applied both before and during positron emission tomography (PET)     scanning. This test shows which parts of the brain are active and which are not and is     important for studying how different parts of the brain work together to feel and react to     specific sensations. For this procedure, the subject lies on a table in the PET scanner while     a series of scans are taken during different sensory conditions. At the beginning of each     scan, radioactive water is injected into an arm vein through a catheter (a thin plastic     tube). A special camera records the arrival and disappearance of the radiation in various     brain areas, creating a picture of the brain's activity in various regions. Oral surgery     patients may have PET scans both before and after their wisdom tooth extraction. Alfentanil,     a commonly used narcotic pain reliever, will also be given during the PET procedure to     determine how the brain responds to sensory stimuli while under the effects of a pain killer.      Participants will also have a magnetic resonance imaging (MRI) scan of the brain to help     interpret the PET results. MRI uses a magnetic field and radio waves to show structural and     chemical changes in tissues. During the scan, the subject lies on a table in a cylindrical     machine (the scanner). He or she can speak with a staff member via an intercom system.      Some sensory studies may require placing an arterial and/or intravenous line. Following     injection of a local anesthetic, a catheter is placed in an artery in the arm. At regular     intervals during various sensory stimuli, small blood samples are drawn from the artery to     measure blood gases and other substances. Samples may also be drawn from a catheter placed in     a vein.      Subjects may also have ultrasound monitoring to evaluate blood flow in the arteries, veins     and brain. A gel is spread over the skin above the blood vessel and a hand-foot-and-mouth     device is placed on the gel. The device emits high-frequency sound waves to produce a picture     of the speed of blood flow in the artery and the diameter of the vessel.   "
161742|NCT00001308|"     Positron Emission Tomography (PET) is a technique used to investigate the functional activity     of the brain. The PET technique allows doctors to study the normal biochemical and metabolic     processes of the central nervous system of normal individuals and patients with neurologic     illnesses without physical / structural damage to the brain. Radioactive water H215O in PET     scans permits good visualization of areas of the brain related to speech.      Most of the PET scan studies conducted have concentrated on learning about how language is     formed and decoded. Few studies have been conducted on speech production. This study aims to     use radioactive water (H215O) and Positron Emission Tomography (PET scan) to measure blood     flow to different areas of the brain in order to better understand the mechanisms involved in     speech motor control.      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and     water. Blood carries fuel to the brain and waste products away from the brain. As brain     activity increases blood flow to and from the area of activity increases also. Knowing these     facts, researchers can use radioactive chemicals (H215O) and PET scans to observe what areas     of the brain are receiving more blood flow.      Researchers will ask patients to perform tasks that will affect speech, voice, and language.     At the same time patients will undergo a PET scan. The tasks are designed to help researchers     observe the blood flow to brain areas associated with voicebox (laryngeal) functions,     movement of muscles in the jaw, tongue, and mouth, and other aspects of motor speech.      Special studies will be conducted to evaluate how certain therapies and tasks can draw out     symptoms in illnesses in which speech and language are affected. Results of these tests will     be used in other studies to evaluate the neurologic mechanisms of diseases like Tourette's     syndrome and parkinson's disease.<TAB>   "
161774|NCT00000763|"     To assess toxicity and determine the MTD of intravenous TNP-470 administered weekly in     patients with AIDS-related Kaposi's sarcoma. To assess pharmacokinetics and tumor response of     the drug.      Since evidence shows that neovascularization is important in the development of Kaposi's     sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients with     the disease.   "
161744|NCT00001310|"     The purpose of this project is to diagnose and evaluate ocular and related tissues with     various diseases such as conjunctival, corneal, uveal, vitreoretinal and optic nerve     disorders, ocular degenerative, metabolic or genetic diseases and tumors. These will be     studied using light microscopy, electron microscopy, confocal microscopy,     immunohistochemistry, molecular pathological including polymerase chain reaction and in situ     hybridization, as well as measuring the functions of cellular organelles, e.g., mitochondrial     function. Lymphocytes in the peripheral blood as well as other involved biopsied tissues and     ocular tissue will be compared and categorized by disease. Cytokines, chemokines or growth     factors and/or other released molecules in the blood and ocular fluids will be also analyzed.     Elucidating the relationship between the infiltrating cells, ocular resident cells, and their     products in various diseases will help us to make diagnoses and increase our understanding of     human ocular disorders.      Patients who require eye surgery to treat an eye disease or other disease in which the eye is     involved may participate in this study. Samples of eye tissue and fluid that are normally     removed and discarded during eye surgery will instead be given to researchers for study. The     tissues will be examined under microscope and studied using sophisticated chemical and     biological tests. Immune cells from blood samples may also be examined. These studies will     help better understand and diagnose the various eye diseases and to develop more attractive     therapies.   "
161745|NCT00001311|"     This study will test the effectiveness of an intraocular lens treated with heparin in     reducing or preventing inflammation after cataract surgery in patients with uveitis.      Patients with uveitis (inflammatory eye disease) often develop cataracts (clouding of the     lens of the eye) that can impair eyesight. Cataracts can be removed surgically, and this is     usually done when poor vision interferes with adequate daily functioning, or when the lens     becomes too cloudy to evaluate the level of eye inflammation in uveitis-information needed to     adjust medication dosages. After surgery, vision is corrected with special eyeglasses,     contact lenses, or intraocular lenses (IOL). IOLs are small, plastic artificial lenses     permanently placed inside the eye.      Patients with uveitis who require cataract surgery and whose eye inflammation has been     controlled by medicine for at least 3 months may be eligible for this study. Those enrolled     in the study will be randomly assigned to one of two treatment groups: one group will have a     standard IOL implanted during cataract surgery; the other will receive a heparin-treated IOL.      Before surgery, patients will undergo standard preoperative tests, including chest X-ray,     electrocardiogram, blood tests and urinalysis, as well as an eye examination that includes     photography of the cornea, iris and retina. Additional tests and examinations to be done at     the start of the study and at periodic follow-up visits for about 1 year may include:     fluorescein angiography to evaluate the blood vessels of the retina; specular microscopy to     examine the surface of the IOL; cell and flare measurements to evaluate inflammation, and     ultrasound to examine the back of the eye.   "
161746|NCT00001313|"     In this study researchers will admit and evaluate patients with known or suspected heart     disease referred to the Cardiology Branch of the National Heart, Lung, and Blood Institute     (NHLBI).      Patients participating in this study will undergo a general medical evaluation, including     blood tests, urine, examination, chest x-ray and electrocardiogram (EKG). In addition,     patients may be asked to have an echocardiogram (ultrasound scan of the heart) and to perform     an exercise stress test.      These tests are designed to assess the types and causes of patient's heart diseases and to     determine if they can participate in other, specific research studies.   "
161747|NCT00001314|"     In this study researchers plan to perform a diagnostic test called transesophageal     echocardiography in order to see and record the movement and function of the heart.      Transesophageal echocardiography is similar to an upper gastrointestinal endoscopy. Different     views of the heart are taken by a small, flexible instrument positioned in the esophagus (the     tube that connects the mouth to the stomach). This allows doctors to create a clear picture     of the heart through the wall of the esophagus rather than from outside the body through the     muscles, fat, and bones of the chest wall.      During transesophageal echocardiography pictures of the heart will be taken while patients     rest and as patients receive a medication called dobutamine. Dobutamine is a medication that     makes the heart beat stronger and faster, similar to what exercise does to the heart.      Researchers are particularly interested in studying patients with defects in the valves of     the heart, especially aortic regurgitation and mitral regurgitation. Patients with these     defects in the heart valves tend to develop abnormalities in the size and function of the     left ventricle. The left ventricle is one of the four chambers of the heart responsible for     ejecting blood out of the heart into the circulation. Researchers believe that by identifying     changes in the function of heart muscle, they may be able to predict the occurrence of muscle     damage due to the diseased valves.      The purpose of this study is to determine whether the function of heart muscle measured     during dobutamine stress transesophageal echocardiography can predict the later development     of problems in the function and size of the left ventricle.   "
162168|NCT00002038|"     The primary purpose of this protocol is to provide fluconazole for the treatment of     individual patients who require therapy for serious or life-threatening systemic fungal     infection, who have failed on conventional antifungal therapy or have had unacceptable     reactions to conventional antifungal therapy, and who are ineligible for other established     fluconazole clinical trial protocols.   "
161763|NCT00000752|"     To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone     dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant (     Deconsal II ) alone, when these agents are given individually or in combination for the     prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare     the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the     evaluation and management of HIV-infected patients with recurrent paranasal sinus infection.     To determine relevant prognostic factors and the microbiologic etiology of maxillary     sinusitis in this patient population.      Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory     to traditional therapy, particularly in patients with advanced immunosuppression. An     intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears     to be warranted.   "
162206|NCT00002076|"     To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal     meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.   "
161748|NCT00001316|"     Our laboratory has previously demonstrated that lymph nodes are a major reservoir for human     immunodeficiency virus (HIV) and a major site of active virus replication in infected     individuals(1-3). There is at least a 10 fold greater viral burden per given number of CD4+ T     lymphocytes obtained from the lymph nodes versus the peripheral blood in the same infected     individual. These data have been accumulated predominantly in individuals with progressive     generalized lymphadenopathy (CDC Class A1 and A2). It is unclear at present whether this     pattern holds true for all categories of HIV infected individuals. We have proposed that the     seeding of lymph nodes by HIV early in the course of HIV infection and the persistent     production of virus in lymph nodes throughout the course of infection are major factors in     the pathogenesis of HIV in virtually all infected individuals. In addition, it is likely that     the selective perturbations of various T cell subsets (i.e., V-B classes of CD4+T cells) that     have been observed in peripheral blood are much more dramatic in the lymph node given the     greater viral burden in the lymph node compared to the peripheral blood. In order to     investigate this hypothesis, it is essential that we study simultaneously lymph nodes and     peripheral blood from the same individuals and that we study different individuals at various     stages of disease from early in the course of infection (CDC Class A) to advanced disease     (CDC Class B and C). If, as we suspect, there is active virus replication in the lymph node     early in the course of infection, even at a time when there is little virus burden or active     replication in the peripheral blood, this would justify anti-retroviral therapy at the     earliest possible time in the course of infection. In addition, in certain patients who are     about to initiate treatment with an anti-retroviral agent such as zidovudine or didanosine     through their private physician, it would be important to know whether treatment actually     reduces the viral burden and virus replication in lymph nodes. The effect of therapy on viral     burden and replication will be compared in the lymph node versus peripheral blood mononuclear     cells and both of these parameters will be compared with the level of plasma viremia.   "
161749|NCT00001317|"     In a recent double-blinded, placebo-controlled multi-center international study, subcutaneous     injections of interferon-gamma administered three times weekly reduced the frequency of     serious infections in patients with chronic granulomatous disease. Patients receiving     interferon-gamma had fewer hospital stays, shorter in length, than the placebo group.     Children less than 10 years of age benefitted most from treatment and had fewer side effects.      Based on these data, the FDA licensed interferon-gamma for prophylaxis in CGD patients. We     wish to monitor our patients who participated in the original study for possible long-term     side effects. Any new patients referred to us who are either on interferon-gamma or     considered to be candidates for interferon-gamma will be considered for this protocol. In     addition, our patients who were originally accepted under Genentech's compassionate plea     protocol will also be monitored under this new protocol. The patients will be evaluated every     six months, with blood work and interim medical histories taken.   "
161750|NCT00001318|"     This is an open label study to determine the effects of the administration of     Interferon-gamma on the clinical condition and immune function of patients with severe,     treatment refractory non-tuberculosis mycobacterial infections. The study drug (interferon     gamma) will be administered subcutaneously three times a week at 0.05 mg/m(2) for one year.     We may also collect blood from the relatives of these patients and normal volunteers in order     to characterize the genetic basis, if any, of our patients' disorders.   "
161751|NCT00001319|"     This study will evaluate HIV-negative patients with unusually low levels of CD4+ T     lymphocytes (a type of white blood cell) to learn more about the clinical symptoms, cause,     immunology, and biology of this problem. CD4+ T lymphocytes play an important role in immune     function, and low counts may leave people susceptible to unusual infections. CD4+ T cell     deficiencies are most often associated with HIV infection.      Patients 8 years of age and older with CD4+ T cell counts below 300 cells/mm3 who test     negative for HIV infection by standard blood tests may be eligible for this study. Patients'     family members and partners may also be enrolled to investigate the possible role of a     genetic factor or exposure to some agent in this problem.      Patients will be evaluated at the NIH Clinical Center at least once, and generally two or     more times. The evaluations, which may be done on an inpatient or outpatient basis, will     include some or all of the following tests and procedures:        -  Complete physical examination.        -  Medical history, including questions about sexual contacts, intravenous drug use,          travel, blood transfusions, previous illnesses, including sexually transmitted diseases,          and health of family members.        -  Urine test.        -  Blood tests for routine and research purposes, including tests for HIV, hepatitis,          syphilis and other infections, evaluation of immune function, and culture for viruses in          the HIV family. No more than 1 pint of blood will be drawn every 6 weeks.        -  Pregnancy test for women of childbearing potential.        -  Skin tests for tuberculosis and immune function. These tests involve injecting a small          amount of the substance to be tested just under the skin and looking for a raised area 1          to 2 days later.        -  Apheresis. Whole blood is collected through an arm vein (similar to donating blood), and          circulated through a cell separator machine, where it is spun to separate the          components. The red cells are then returned to the patient either through the same          needle or through a needle in the other arm, and the plasma and white cells are          extracted for study. The procedure, which takes 1 to 2 hours, may be repeated up to 3          times.      Family members will have 60 cc (4 tablespoons) of blood drawn to determine CD4+ T cell     counts.   "
161752|NCT00001320|"     Brain cells communicate with each other by releasing chemicals called neurotransmitters. In     order for brain cells to transfer information, one cell will release a neurotransmitter that     will be recognized by a receptor located on surface of another cell. One such     neurotransmitter is dopamine.      Abnormal dopamine transmission has been seen in patients with substance abuse and different     neuropsychiatric disorders including schizophrenia.      A radioactive drug called IZBM (I-123 iodobenzamide) can also bind to certain dopamine     receptors. IZBM can be seen by Single Photon Emission Tomography (SPECT). Therefore, by using     IZBM and SPECT scans, researchers can find and map the location of dopamine receptors in     the brain.      Patients participating in this study must also have been selected for other genetic studies     being conducted at the NIMH. Patients with schizophrenia will be selected from a NIMH     research study titled, Neurobiological Investigation of Patients with Schizophrenia Spectrum     Disorders and Their Siblings (95-M-0150). Normal patient volunteers will be selected from     another NIMH study titled, Inpatient Evaluation of Neuropsychiatric Patients (89-M-0160).     All aspects of clinical care and genetic analysis of these patients will be covered in these     studies, while information pertaining to IBZM SPECT scans will be covered in this study.      This study will not directly benefit patients participating in it. However, information     gathered may contribute to faster and more accurate diagnosis of schizophrenia and eventually     better treatment for the disorder.   "
161753|NCT00001322|"     This study evaluates the effects of estrogen and progesterone on mood, the stress response,     and brain function in healthy women.      The purpose of this study is to evaluate how low levels of estrogen and progesterone (that     occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen     and progesterone (given during individual months of hormone add-back) on a variety of     physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without     PMS.      This study will investigate effects of reproductive hormones by temporarily stopping the     menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle     hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.)     will be performed during the different hormonal conditions (low estrogen and progesterone,     progesterone add-back, estrogen add-back). The results of these studies will be compared     between women without PMS and women with PMS (see also protocol 90-M-0088).      At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy     tests will be performed. Cognitive functioning and stress response will be evaluated during     the study along with brain imaging and genetic studies.   "
161755|NCT00001324|"     Positron Emission Tomography (PET) is a technique used to investigate activity in areas of     the brain. The PET technique allows researchers to study the normal processes in the brain     (central nervous system) of normal individuals and patients with neurologic illnesses without     physical / structural damage to the brain.      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and     water. Blood carries fuel to the brain and waste products away from the brain. As brain     activity increases, blood flow to and from the area of activity also increases. This is known     as regional cerebral blood flow (rCBF). Knowing these facts, researchers can use radioactive     water (H215O) and PET scans to observe what areas of the brain are receiving more blood flow.      In this study researchers plan to investigate the changes in regional cerebral blood flow     (rCBF) as patients participate in different activities. The activities are designed to     stimulate the areas of the brain responsible for voluntary motor activity and sensation. By     comparing the results of PET scans performed in different conditions, researchers can locate     regions of the brain responsible for specific tasks.      This study should provide new information about voluntary movements in humans and the     preparation involved in controlling them.   "
161756|NCT00001325|"     This study is designed to use positron emission tomography to measure brain energy use.     Positron Emission Tomography (PET) is a technique used to investigate the functional activity     of the brain. The PET technique allows doctors to study the normal processes of the brain     (central nervous system) of normal individuals and patients with neurologic illnesses without     physical / structural damage to the brain.      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and     water. Blood carries fuel to the brain and waste products away from the brain. As brain     activity increases blood flow to and from the area of activity increases also.      Researchers can label a sugar with a small radioactive molecule called FDG     (fluorodeoxyglucose). As areas of the brain use more sugar the PET scan will detect the FDG     and show the areas of the brain that are active. By using this technique researchers hope to     answer the following questions;      4. Are changes in brain energy use (metabolism) present early in the course of epilepsy      5. Do changes in brain metabolism match the severity of patient's seizures      6. Do changes in metabolism occur over time or in response to drug therapy   "
161757|NCT00001327|"     The brain and spinal cord are surrounded by fluid called cerebrospinal fluid (CSF). The CSF     flows through channels in the brain and around the spinal cord. Occasionally, people are born     with malformations of these channels. Syringomyelia is a pocket within the CSF channels that     results from abnormal CSF flow. Syringomyelia is associated with problems in the nervous     system. Patients with syringomyelia may be unable to detect sensations of pain and heat. If     the condition is not treated it can worsen.      Treatment of this condition is surgical. It requires that the flow of CSF is returns to     normal. There are many different treatment options, but no one procedure has been shown to be     significantly better than any other.      In this study, researchers would like to learn more about how the CSF pressure and flow     contribute to the progression of syringomyelia. Ultrasounds and magnetic resonance imaging     (MRI) will be used to evaluate the anatomy of the brain. Researchers hope that information     gathered about anatomy and measures of CSF pressure and flow can be used later to develop an     optimal surgical treatment for syringomyelia.   "
161758|NCT00000747|"     Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected     individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts     greater than or equal to 500 cells/mm3.      Secondary: To evaluate the effect of nevirapine on surrogate markers. The anti-HIV agent     nevirapine is associated with rapid emergence of resistance when administered alone or in     combination with zidovudine to HIV-infected patients with CD4 counts <= 400 cells/mm3. In     persons with less advanced HIV disease and less viral burden, the emergence of resistance may     be delayed, thus permitting evaluation for beneficial effect in a population where there is     currently no established therapy.   "
161759|NCT00000748|"     To compare the safety and efficacy of two dosage regimens (daily and thrice-weekly) of     sulfamethoxazole/trimethoprim (SMX/TMP; TMS) in the prevention of Pneumocystis carinii     pneumonia (PCP) in high-risk HIV-infected patients.      Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of     PCP and may be effective in preventing PCP in patients who have never developed it. Because     SMX/TMP can cause side effects, this study will attempt to determine the safest and most     effective dose of this combination.   "
161760|NCT00000749|"     To evaluate in healthy volunteers the safety and immune response to 200 mcg gp120 candidate     vaccine in MF59 emulsion without MTP-PE at 0, 1 and 6 months.      Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol     VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest.   "
161761|NCT00000750|"     Primary: To determine the efficacy of early treatment with zidovudine (AZT) in HIV-infected     asymptomatic infants. To determine the safety and tolerance of AZT in this patient     population.      Secondary: To compare the virologic and immunologic parameters between the treatment groups.     To determine the efficacy of AZT as an early treatment to prevent development of CD4+ cell     depletion in HIV-infected asymptomatic infants.      AZT is currently indicated for primary treatment in children with HIV-associated signs and     symptoms and for those with significant immunodeficiency. This study will attempt to     determine whether early treatment with AZT prevents the development of symptoms in     HIV-infected infants who are asymptomatic.   "
161762|NCT00000751|"     To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin     (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT)     administered intrapartum and to the newborn, on incidence of HIV infection in infants born to     HIV-infected women who received AZT during pregnancy for medical indications.      Vertical transmission of HIV from mother to child may occur before, during, or after     parturition (via breast-feeding). It is believed that therapy administered both during     pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive     short-term antiretroviral therapy for the newborn, following the intensive viral exposure     presumed to occur at birth, may be necessary.   "
165659|NCT00006407|"     To investigate the relationship between endogenous estrogen and androgen levels and risk of     coronary heart disease among postmenopausal women in the Women's Health     Initiative-Observational Study (WHI-OS).   "
161767|NCT00000756|"     To determine the safety, tolerance, and feasibility of adoptive immunotherapy with autologous     cytotoxic T-lymphocytes (CTLs) in HIV-infected patients with CD4 counts between 100 and 400;     to evaluate the immunologic, virologic, and clinical changes for up to 24 weeks following     infusion of study therapy.      Freshly isolated peripheral blood lymphocytes from HIV-1-seropositive individuals frequently     lyse autologous HIV-1-expressing cells or autologous cells infected with vaccinia vectors     encoding HIV-1-specific proteins. Administration of these cytotoxic T lymphocytes (CTLs) may     help prevent HIV disease progression.   "
161768|NCT00000757|"     To evaluate the safety and immune response to 160 mcg HIV-1 recombinant envelope glycoprotein     gp160. To evaluate the duration of antibody response and its relationship to dose and     frequency of inoculation.      Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicate     that, although serum anti-gp160 antibody responses were detected, the level and duration of     those responses were limited. A preliminary observation suggests that weak functional     antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a     dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.   "
161769|NCT00000758|"     To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis     in HIV-infected women who have received standard ablative therapy (surgery) for high-grade     cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To     correlate time to recurrence of cervical dysplasia with T-cell function.      Women with HIV infection are at greater risk for cervical dysplasia. Because of the     likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer,     there is an urgent need to develop appropriate therapies.   "
161770|NCT00000759|"     AS PER AMENDMENT 10/24/96: To develop a domain/construct-driven neuropsychological and     neurological battery. Scaling of instruments to allow measurement of functions from infancy     to early adulthood; establish reliability and validity of the new instruments developed for     the NIMH Neurodevelopmental Battery. Downward extension of cognitive domains into infancy and     early childhood. To describe and compare outcomes when assessing level of development versus     rate of change. Describe and compare the outcomes from a global assessment of     neurodevelopment (e.g., a standardized I.Q. score) versus discrete assessments (e.g.,     functional domains such as motor or language skills). Develop guidelines for multicultural     neuropsychological and neurological assessment within a clinical trials design. Describe the     nature of impaired developmental abilities and course of the disease in infants and children.      The assessment of children who sustain central nervous system (CNS) insult requires     approaches that differ in several ways from adult-based assessment. The rapid changes that     occur in the developing CNS as well as in behavior reflect underlying processes of growth and     development.   "
161771|NCT00000760|"     To study the anti-HIV activity of the various doses of Ro 24-7429 monotherapy based on     virologic and immunologic endpoints. To study the safety and tolerance of Ro 24-7429. To     explore relationships between exposure to Ro 24-7429 and its metabolites and antiviral     activity and drug toxicity. To determine a safe, tolerable, and active dose regimen of Ro     24-7429, and to make preliminary observations of Ro 24-7429 in combination with another     antiretroviral nucleoside.      The HIV genome contains a number of genes that regulate viral replication. Control of the     activity of these genes and their encoded proteins represents a potential target for     development of new antiretroviral drugs. The tat (transactivator of transcription of HIV)     antagonist Ro 24-7429 is the first compound for clinical testing that utilizes this approach     for therapy of HIV infection.   "
162287|NCT00002157|"     To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2     doses. To gain safety and efficacy data from a broader base of patients with HIV-associated     wasting in order to support Celgene's pivotal placebo-controlled study.   "
161775|NCT00001328|"     Malignant brain tumors are responsible for a significant amount of deaths in children and     adults. Even with advances in surgery, radiation therapy, and chemotherapy, many patients     diagnosed with a malignant brain tumor survive only months to weeks.      In an attempt to improve the prognosis for these patients, researchers have developed a new     approach to brain tumor therapy. This approach makes use of DNA technology to transfer genes     sensitive to therapy into the cells of the tumor.      Infections with the herpes simplex virus can cause cold sores in the area of the mouth. A     drug called ganciclovir (Cytovene) can kill the virus. Ganciclovir is effective because the     herpes virus contains a gene (Herpes-Thymidine Kinase TK gene) that is sensitive to the drug.     Researchers have been able to separate this gene from the virus.      Using DNA technology, researchers hope to transfer and implant the TK gene into tumor cells     making them sensitive to ganciclovir. In theory, giving patients ganciclovir will kill all     tumor cells that have the TK gene incorporated into them.   "
161776|NCT00001329|"     Brain and nerve cells communicate with each other by releasing and picking up chemicals     called neurotransmitters. Norepinephrine is a neurotransmitter used by part of the nervous     system activated during stress called the sympathetic nervous system. The sympathetic nervous     system is involved with regulating blood pressure and pulse rate. Researchers believe the     level norepinephrine in the blood can be used to measure activity of the sympathetic nervous     system.      This study is designed to answer important questions about rates of release of norepinephrine     into the blood stream, removal of released norepinephrine, and the sympathetic nervous system     response to stress.      Researchers will attempt to measure levels of norepinephrine and activity of the sympathetic     nervous system in patients with high blood pressure, normal patients with family histories of     high blood pressure, patients taking drugs that can effect levels of norepinephrine, and     patients with diseases or conditions directly affecting the sympathetic nervous system.   "
161791|NCT00001346|"     The purpose of this study is to evaluate possible mechanisms of central visual loss in     patients with diabetes mellitus. The visual loss of interest to be investigated is that     associated with macular edema (prior to and following laser photocoagulation treatment) and     that associated with panretinal photocoagulation. The evaluation will be performed with     psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of     particular interest, the mechanisms of visual loss associated with macular edema (prior to     and following laser photocoagulation) will be further investigated. Photoreceptor-mediated     visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss     mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer     spatial desensitization/sensitization effect.   "
161777|NCT00001330|"     This study will examine the possible relationship between silicone implants or injections and     the connective tissue diseases scleroderma and myositis. It will explore whether certain     factors in the blood or the immune system or other factors are involved in the development of     these diseases following silicone implantation or injection.      Men and women 18 years of age and older who meet the following criteria may be eligible for     this study:      Group 1-Patients who have had silicone implants or injections and who later developed     scleroderma or myositis      Group 2-Patients with scleroderma or myositis who have not had silicone implants or     injections      Group 3-Healthy volunteers who have had silicone implants or injections and did not develop     symptoms or other medical features of connective tissue disorders.      Participants will have a thorough history and physical examination, blood and urine tests,     chest X-ray and lung function tests. In addition, patients will complete a questionnaire     about their procedure (including information such as the types of implanted devices and     injections, reason for the procedure, post-operative complications, other illnesses or     medical conditions present before and after the procedure, etc.).   "
161778|NCT00001331|"     The purposes of this study are to identify gene mutations in patients with the muscle     diseases phosphofructokinase (PFK) deficiency, acid maltase deficiency (GAA deficiency) and     to learn more about how these diseases develop. PFK deficiency is a mild, exercise-related     illness. The childhood form of GAA deficiency (Pompe disease) affects the heart and liver and     is rapidly fatal. The adult form begins in midlife and involves degeneration of skeletal     muscles, leading to weakness and muscle wasting.      The following groups of individuals may be eligible for this study:      Group A: Patients with PFK deficiency, acid maltase deficiency, and relatives who also are     affected. Participants in this group will undergo a brief medical and family history, blood     sample collection, and possibly a physical examination, review of medical records, and     interview with the patient's physician.      Group B: Unaffected family members of patients in group A, including both blood relatives and     spouses. People in this group may be asked to provide a history and genetic information. A     review of medical records, interview with the individual's physician, and blood sample may     also be requested.      Group C: Control subjects. This group will provide a small blood sample or buccal mucosal     sample (tissue sample collected by brushing the inside of the cheek). The samples will be     coded and the investigators will not know the participants' identities. DNA from these     samples will be analyzed for frequency of gene mutations.      Genetic counseling will be arranged for patients, as appropriate.   "
161779|NCT00001332|"     Patients with gastric adenocarcinoma are most frequently diagnosed at an advanced stage. The     disease has a marked propensity for loco-regional spread and will be the sole or major site     of disease in up to 80% of patients. Various attempts at controlling loco-regional disease     have not been successful. The selective lethal effect of supranormal temperatures on     neoplastic cells and the additive or synergistic effect of combining chemotherapy has been     well established in laboratory models and has provided the rationale for numerous clinical     trials using hyperthermic isolated limb perfusion for advanced extremity melanoma or sarcoma.     This Phase I study will evaluate the safety of escalating temperatures of continuous     hyperthermic peritoneal perfusion (CHPP) with escalating doses of intraperitoneal Cisplatin     (CDDP) in the treatment of patients with advanced peritoneal adenocarcinoma of     gastrointestinal origin.   "
161780|NCT00001333|"     The purpose of this study is to determine the qualitative and quantitative toxicity of     intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies     refractory to conventional therapy (radiation therapy and chemotherapy).   "
161825|NCT00001415|"     A variety of hormones and immune system processes are responsible for how the body responds     to illness. This study concentrates on how the hormone cortisol effects the release of immune     system factors called cytokines.      Cortisol is a hormone produced in the adrenal glands as a response to stimulation from the     pituitary gland. Abnormal levels of cortisol have been seen in several diseases such as     depression and multiple sclerosis.      Cytokines are factors produced by certain white blood cells. They act by changing the cells     that produce them (autocrine effect), altering other cells close to them (paracrine), and     effecting cells throughout the body (endocrine effect). Cytokines are important in     controlling inflammation processes.      In this study researchers would like to determine if changes in levels of hormones in the     blood are associated with changes in cytokine levels. In addition, researchers would like to     learn more about how cytokines respond to hormones in certain diseases.   "
161781|NCT00001335|"     The prognosis for patients with metastatic Ewing's sarcoma family of tumors (ESF),     rhabdomyosarcoma (RMS), and neuroblastoma (NBL) remains dismal, with less than 25% long-term     disease-free survival. Though less grave, the prognosis for cure for other high-risk patients     is approximately 50%. New treatment strategies, including the identification of highly active     new agents, maximizing the dose intensity of the most active standard drugs, and the     development of improved methods of consolidation to eradicate microscopic residual disease,     are clearly needed to improve the outcome of these patients. This protocol will address these     issues by commencing with a Phase II window, for the highest risk patients, to evaluate a     series of promising drugs with novel mechanisms of action. All patients will then receive 5     cycles of dose-intensive best standard therapy with doxorubicin (adriamycin), vincristine,     and cyclophosphamide (VAdriaC). Patients at high risk of relapse will continue onto a phase I     consolidation regimen consisting of three cycles of dose-escalated Melphalan, Ifosfamide,     Mesna, and Etoposide (MIME). Peripheral blood stem cell transfusions (PBSCT) and recombinant     human G-CSF will be used as supportive care measures to allow maximal dose-escalation of this     combination regimen.   "
161782|NCT00001336|"     Peripheral blood mononuclear cells (PBMC) will be collected from patients who have leukemia     or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or     immunological function. These PBMC will be assessed for cellular markers by flow cytometry     and will be studied for in vitro T helper, effector and suppressor cell functions, to     determine whether cell mediated immunity is involved in the condition, or indicative of     therapeutic efficacy or is predictive for outcome. Peripheral blood stem cells (PBSC) from     untreated donors and from cytokine treated donors will be assessed for cellular markers and     in vitro growth characteristics that might be useful for identifying normal stem cell     populations.   "
176032|NCT00144534|"     This is an open-label, extension, Phase III study to evaluate the long-term safety and     efficacy of MRA in patients with RA who participated in Study MRA213JP.   "
161784|NCT00001338|"     This is a prospective, randomized Phase III trial of FLAC chemotherapy with GM-CSF versus     PIXY321 in advanced breast cancer. The primary endpoints of this study will be the duration     of thrombocytopenia and the time to recovery of platelets to 50,000/microliters. Other     clinical endpoints will include the depth and duration of leukopenia, neutropenia, and     anemia, the platelet and RBC transfusion requirements, and the number of documented instances     of sepsis and hospitalizations for fever and neutropenia.      Laboratory correlates will include the detailed evaluation of the effects on circulating     hematopoietic progenitor cells by GM-CSF and PIXY321 and the potential effects these agents     have on the bone marrow micro-environment.      After 5 cycles of FLAC with GM-CSF versus PIXY321, patients will be treated with 5 cycles of     96 hour infusional taxol. The goal of this part of the study will be to assess the toxicity     and feasibility of administering infusional taxol following dose-intensive FLAC chemotherapy.   "
161785|NCT00001339|"     Patients who have no response to preoperative chemotherapy and no residual disease following     surgery on Regimen A are treated on Regimen B postoperatively.      The following acronyms are used:      DDD Mitotane, NSC-38721      DOX Doxorubicin, NSC-123127      VCR Vincristine, NSC-67574      VP-16 Etoposide, NSC-141540      Regimen A: 4-Drug Combination Chemotherapy followed by Surgery followed by 4-Drug Combination     Chemotherapy. DDD/DOX/VCR/VP-16; followed by surgical debulking; followed by     DDD/DOX/VCR/VP-16.      Regimen B: Single-Agent Chemotherapy. DDD.   "
161786|NCT00001341|"     Thymidylate synthase (TS), an enzyme which acts by utilizing 5,10-CH(2)FH(4) in the reductive     methylation of deoxyuridylate (dUMP), is required for the de novo synthesis of thymidylate     and is a potential chemotherapeutic target. ZD1694 is a new quinazolone folate analog that     directly inhibits TS. This phase I trial and pharmacokinetic study will describe and define     the toxicities, determine the MTD, and describe the plasma pharmacokinetics of ZD1694 in     pediatric patients with refractory cancer. The starting dose for this trial will be 2.0     mg/m(2) administered as a 15 minute IV infusion every 21 days.   "
161787|NCT00001342|"     Glycogen, is the storage form of glucose. It is usually formed from sugar and stored in the     liver. When tissues, such as muscle, need glucose for fuel the stored glycogen is converted     into glucose with the help of enzymes produced in the body. Glycogen storage disease (GSD)     refers to a group of conditions characterized by abnormal storage of glycogen due to the     absence of particular enzymes needed in the process of storing and using glycogen.      This study addresses the related metabolic abnormalities of glycogen storage disease (GSD).     As patients with disorders of glycogen metabolism are followed it becomes apparent that the     condition is much more complex than initially thought.      Researchers believe that patients suffering from glycogen storage disorders should be     followed and monitored for other heritable metabolic disorders.      This study will attempt to determine the frequency of associated disorders in patients with     GSD. In addition, the study will look at the current management of these patients to see if     the prognosis and course of the disease is changed.   "
161788|NCT00001343|"     Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes.     Patients with Turner syndrome are typically short, have abnormal physical features, and lack     the physical changes normally associated with puberty. In addition, some patients with Turner     syndrome have low bone density (osteoporosis) and differences in learning abilities.      This study will research the effects of steroid hormones on patients with Turner syndrome. It     will look closely at how taking steroid hormones effects the patient's rate of growth as well     as the patient's ability to learn. In addition the study will investigate how different     hormones (androgen and estrogen) work when given together as a combination.      All patients asked to participate in this study will receive growth hormone injections.     However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in     the form of a pill. The other half of the patients will receive a placebo or sugar pill.     This will allow the researchers to determine if the combination of the hormones produces     different results than growth hormone alone.      The study will last approximately 2 years. After 2 years of research the patients may qualify     for an additional 2 years of treatment. Patients may benefit directly from this research with     increased growth and improved ability to learn.   "
165660|NCT00006408|"     To investigate the relationship between life-stress factors associated with socioeconomic     conditions and hypertension.   "
161789|NCT00001344|"     In our current clinical trial, we are comparing the effects of two NMDA receptor antagonists     to placebo in patients with painful distal symmetrical diabetic neuropathy or post-herpetic     neuralgia. The treatments in this three-period crossover study are dextromethorphan, up to     920 mg/day (about 8 times the antitussive dose), memantine, 30-50 mg/day, and placebo.     Memantine is an NMDA antagonist used in Europe to treat Parkinson's disease and Alzheimer's     disease. The underlying hypothesis, based on studies of painful neuropathies in animal     models, is that neuropathic pain is caused largely by sensitization of central nervous system     neurons caused by excitatory amino acid neurotransmitters, acting largely through NMDA     receptors. A previous small trial of dextromethorphan suggested efficacy in diabetic     neuropathy pain. The study requires one visit to the NIH outpatient Pain Research Clinic, and     consists of three 9-week treatment periods. Patients who respond to one of the medications     will be invited to participate in further controlled studies of the medication followed by up     to several years of open-label treatment under continued observation.   "
161790|NCT00001345|"     Diseases of mineral metabolism such as familial multiple endocrine neoplasia type 1 (FMEN1),     familial hypocaliuric hypercalcemia (FHH), familial hyperparathyroidism (FH), and     pseudohypoparathyroidism (PHP) are known as hereditary abnormalities. Meaning these     conditions are passed from parents to their children through genes. These specific conditions     result in abnormal levels of calcium in the blood.      This study was designed to help researchers understand more about the genes that are     responsible for these disorders. By learning more about the genetic process involved in     hereditary abnormalities, new tests and treatments can be developed.      Subjects for this study will be members of families that have had relatives diagnosed with a     disease of mineral metabolism. Participants will be asked to give blood samples for DNA     extraction. DNA is the part of cells that carries genetic information.      The DNA will be analyzed and the results given to the subjects. Genetic counseling will be     provided to subjects to aid in interpreting their results.   "
173877|NCT00118404|"     This study determined the effectiveness of continuation phase cognitive therapy versus     antidepressant medication in preventing relapse of depression in people with recurrent     depression.   "
161792|NCT00001347|"     The purpose of this investigation is to gain additional knowledge about what causes type 1     and type 2 Usher syndrome-inherited diseases that can cause balance problems and impaired     hearing and vision-and to develop better diagnostic tests. Patients with type 1 Usher     syndrome usually are deaf from birth and have speech and balance problems. Patients with type     2 disease generally are hearing impaired but have no balance problems. All patients develop     eye problems that cause difficulty seeing in the dark.      The development of newer and more sophisticated diagnostic tests may detect subtle     differences in signs and symptoms that allow more accurate distinction between the two types     of Usher syndrome. This study will use these tests to classify these syndromes and eventually     identify the genes responsible for them.      Study participants will have a medical and family history taken and a family tree     constructed. They will undergo a thorough eye examination, including special tests of color     vision, field of vision, and ability to see in the dark. An electroretinogram will be done to     measure the function of cells in the retina, and a procedure called fluorescein angiography     will be done to look at and photograph the blood vessels in the retina. Special hearing and     balance tests will also done. Hearing tests include physical examination of the ears and     wearing earphones while listening to tones. Balance and coordination tests require tasks such     as walking in a straight line and standing in the dark with eyes closed. A caloric     stimulation test will also be done, in which a small amount of water is irrigated into the     ear canal. For gene studies, blood samples will be collected from patients and all available     family members.   "
161793|NCT00001349|"     This study will collect blood plasma and white blood cells for laboratory research using a     procedure called apheresis. Apheresis is a method of collecting larger quantities of certain     blood components than can safely be collected through a simple blood draw.      Patients 7 years of age and older with a parasitic infection or condition associated with a     parasitic infection (i.e., elevated levels of IgE antibodies or of a type of white cell     called eosinophils) who are currently enrolled in a NIH clinical research protocol may be     eligible for this study. Relatives of patients and normal healthy volunteers will also be     enrolled. Candidates will have a medical history, physical examination and blood tests.     Individuals weighing less than 25 kilograms (55 pounds) may not participate.      Participants will undergo one of the following two apheresis procedures:        -  Automated pheresis Whole blood is drawn through a needle placed in an arm vein and          circulated through a cell separator machine. The plasma (liquid part of the blood) and          white cells are extracted, and the red cells are re-infused into the donor through a          needle in the other arm. The procedure takes 1 to 2 hours.        -  Manual pheresis Whole blood is drawn through a needle placed in an arm vein and          circulated through the cell separator machine. The red blood cells are separated from          the rest of the blood and returned to the donor through the same needle. Usually only          one needle stick is required and the procedure takes from 30 to 45 minutes. This method          is used only in individuals who weigh less than 35 kg (77 pounds).   "
161794|NCT00001350|"     The purpose of the protocol is to allow for patients, and relatives of patients, who may have     the newly described autoimmune lymphoproliferative syndrome, to be evaluated at the NIH     Clinical Center. This evaluation will include blood and relevant tissue studies along with     long-term clinical evaluations to define the biology, inheritance,clinical spectrum, and     natural history of this syndrome. The aim of the research is to understand mechanisms     involved in the development of expanded numbers of what is typically a rare population of     immune cells (CD4-8-/TCRalpha/beta+ T cells, otherwise referred to as double negative T     cells), and how these relate to the development of expanded numbers of immune cells and     autoimmune (self against self) responses in patients with ALPS.      In some cases, we may proivide treatment related to ALPS. These treatments are consistent     with standard medical practice.      Participants with ALPS will be invited to visit the NIH once a year or more frequently when     clinically indicated for the next few years for clinicians and scientists to follow the     course of their disease and to manage its complications. Knowledge gained from these studies     provides important insights into the mechanisms of autoimmunity, the thymus gland, and the     role that the immune system and genetics plays in ALPS.      Autoimmune lymphoproliferative syndrome is a rare disease that affects both children and     adults. Each of these three words helps describe the main features of this condition. The     word autoimmune (self-immune) identifies ALPS as a disease of the immune system. The tools     used to fight germs turn against our own cells and cause problems. The word     lymphoproliferative describes the unusually large numbers of white blood cells (called     lymphocytes (stored in the lymph nodes and spleens of people with ALPS. The word syndrome     refers to the many common symptoms shared by ALPS patients.      One of the causes of ALPS is defective apoptosis, or said another way, an individual has an     abnormality in how well lymphocytes (immune cells) die when they are instructed to do so. It     is normal for lymphocytes to disintegrate (e.g., die) when they have done their job. In     people with ALPS and in some of their affected relatives, the genetic message for the cells     to die is altered: the message is not received and the cells do not die when they should. As     a result, people with ALPS develop an enlarged spleen, liver and lymph glands, along with a     range of other problems involving white blood cell counts and overactive immune responses     (autoimmune disease). Some patients have an increased risk of developing lymphatic cancers     (lymphoma).      Provided is a description of eligible study candidates:        1. Any patient with ALPS, male or female and of any age. As a patient with ALPS, candidates          must have:             -  a medical history of an enlarged spleen and/or enlarged lymph nodes over an               extended period of time (past and/or current).             -  defective lymphocyte apoptosis, in vitro.             -  greater than or equal to 1 percent TCR alpha/beta+CD4-8- peripheral blood T cells.        2. Relatives (any age) of patients and normal controls (18-65).        3. Healthy normal volunteers will also be enrolled to provide data on normal cell behavior          for comparison with patients.      Additional information regarding ALPS and the research being conducted at the National     Institutes of Health is available at the following World Wide Web (e.g., Internet) locations:      http://www.niaid.nih.gov/publications/alps/      http://www.nhgri.nih.gov/DIR/GMBB/ALPS/.   "
161832|NCT00001424|"     Patients enrolled in this study will not receive investigational therapy. Any treatments     rendered will be standard and based on appropriate medical care. Should a patient become     eligible for an experimental therapy protocol, the normal process of enrollment and informed     consent will be followed.   "
162169|NCT00002039|"     To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS     patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the     safety and efficacy of three different foscarnet maintenance therapy regimens. To determine     the pharmacokinetics of intermittent administration of foscarnet with or without concomitant     administration of zidovudine (AZT).   "
161795|NCT00001351|"     This study will investigate inflammatory diseases and disorders. Inflammation is the body s     immune response to many things, including infections and other acute or chronic irritants. It     may also be a sign of abnormal immune function. This study will allow evaluation and     long-term follow-up of such disorders to:        -  Establish and maintain a group of patients that may be eligible for other NIAID          protocols.        -  Provide clinical training and experience for NIAID fellows.        -  Provide a mechanism for NIAID staff to maintain their clinical skills.        -  Serve as a starting point for new investigations of syndromes not currently under study.      Patients between 1 and 80 years of age with acute or chronic inflammation, including but not     limited to viral, fungal or bacterial infections, or abnormal immune responses may be     eligible for this study. Immediate family members of patients may also be enrolled for     preliminary examination to see if they are affected in any way that may warrant further     investigation.      All patients and family members will have a history, physical examination and laboratory     tests. Depending on the results, family members may require additional tests. Patients will     have additional diagnostic tests indicated for their specific disease, according to accepted     medical standards. These may include routine blood and urine tests, X-rays or other imaging     studies, body fluid or tissue cultures, skin tests for allergic or immune responses, and     others as needed.      Treatments will include only medications approved by the Food and Drug Administration     according to accepted dose schedules and delivery methods.      Patients may be requested to donate extra blood for research studies. No more than 450 cc (30     tablespoons) will be drawn from adults within a 6-week period, and no more that 7 cc (1/2     tablespoon) from children under 18 years of age in the same time period.   "
161796|NCT00001352|"     This 5-year study will follow the course of disease in previously healthy patients with     cryptococcosis who developed the disease for no identifiable reason.      Individuals with a positive culture of Cryptococcus neoformans 18 years of age and older     without HIV infection or other condition predisposing to cryptococcosis (such as high-dose     corticosteroid therapy, sarcoidosis, or a blood cancer) may be eligible for this study.     Candidates who test positive for HIV infection may not participate.      Participants will have a physical examination, medical history, routine blood tests and     assessment of disease activity upon entering the study. Patients who may have active     cryptococcosis will also have a lumbar puncture (spinal tap) and additional blood tests.     Following the initial evaluation, patients receiving treatment for cryptococcosis will come     to the NIH Clinical Center as needed to manage their disease, typically no less than every 3     months. Other patients will be seen every 6 to 12 months. The visits will include a medical     history, physical examination, and blood and urine tests.   "
161797|NCT00001353|"     This study will evaluate the safety of giving lymphocytes (white blood cells) containing a     new gene to HIV-infected individuals and will determine how long the cells survive in the     bloodstream. Although the genetically altered cells will not directly benefit participants,     knowledge about the safety, side effects and survival of these gene-marked cells in     HIV-infected patients may lead to new treatment strategies.      Identical twin pairs 18 years of age and older-one infected with HIV, the other     non-infected-may be eligible for this study. Candidates will be screened with a medical     history, physical examination and blood tests.      All participants will have a tetanus booster shot. Non-infected twins will undergo a     procedure called apheresis to collect white blood cells. For this procedure, whole blood is     collected through a needle in an arm vein, similar to donating blood. The blood is separated     it into its components by centrifugation (spinning), the white cells are removed, and the     rest of the blood is returned to the body, either through the same needle or through another     needle in the other arm. The harvested white cells will be grown in culture for approximately     10 days to 2 weeks to increase their numbers up to 1000-fold. A gene called NeoR, which is     derived from bacteria, will be inserted into the cells, and these gene-marked cells will be     infused into the HIV-infected twin.      HIV-infected twins will be admitted to the NIH Clinical Center for the first cell infusion.     The gene-marked cells will be infused over a 60-minute period through a plastic tube     (catheter) placed in an arm vein, or, if a suitable arm vein cannot be found, through a     special catheter placed into a large vein in the neck or chest. Vital signs (temperature,     pulse, blood pressure and breathing rate), blood oxygen concentration, and urine output will     be monitored regularly for 24 hours. Blood samples will be collected before and after the     infusion to monitor for gene-marked cells. Patients will be discharged the next day. They     will return to NIH daily the first week (from Monday through Thursday) to monitor for CD4     cell counts, plasma viral burden, p24 antigen levels, HIV levels and the presence of the NeoR     gene, and then weekly for the next 5 weeks for these tests and others to monitor blood and     urine chemistry, blood counts and immune function markers.      If the NeoR gene cannot be detected after the first cell infusion, the entire procedure     (donor apheresis, gene marking and infusion of cells) will be repeated twice-about once every     6 weeks. If the first infusion was uncomplicated, the second and third infusions may be done     on an outpatient basis, with monitoring for 6 hours rather than 24. Six weeks after the third     infusion, tests will be scheduled monthly for 6 months and then yearly for long-term     follow-up.      In addition to the above procedures, patients with a baseline CD4 lymphocyte count less than     100 cells per cubic millimeter of blood will be asked to undergo apheresis periodically to     obtain the most accurate results for determining how long the NeoR gene persists in the     blood. The procedure will be done weekly for the first 6 weeks after each infusion of cells,     then at week 8, and then every 4 weeks until the gene can no longer be detected in the     lymphocytes. The schedule may change, but will not require more frequent apheresis.   "
161798|NCT00001354|"     Certain patients who are participating in NIH protocols involving interleukin-2 (IL-2)     therapy for HIV disease may be requested to have the following changes or additions to their     study protocol:        -  3-day subcutaneous (sc) IL-2 administration: Patients currently receiving IL-2          intravenously (injections through a vein) may switch to subcutaneous administration          (injections under the skin). Injections are given twice a day for 3 to 5 days (one          treatment cycle), with cycles repeated no more often than every 8 weeks.        -  Home treatment of sc IL-2: Home administration of IL-2 injections involves less frequent          data and safety monitoring and no medical evaluations at the Clinical Center except at          the beginning of each cycle. Participants will receive IL-2 cycles on the same schedule          they followed in their original protocol. They will be seen at the Clinical Center at          regularly scheduled follow-up visits between cycles and for a medical evaluation and          blood drawing before the start of each cycle to determine the safety of administering          the next cycle. During the home cycle, the patient's case manager or other team member          will place monitoring telephone calls on days 2 and 4 of the cycle and again a week          later. The timing and number of these calls may change depending on the findings of          ongoing assessments of their usefulness. Patients will be required to notify the study          team promptly of complications or other problems that develop with therapy.        -  Stored specimens and HLA testing: Stored blood and tissue samples from patients will be          used for future research on HIV, AIDS and related medical conditions, and the immune          system. The samples may be labeled with no identifying information, with identifying          information, such as the patient's name, or with a code that only the study team can          link to the patient. Some of the blood drawn may be used for HLA typing, a genetic test          of markers of the immune system. Usually used to match bone marrow or organ transplants,          HLA type might also be used to try to identify factors associated with the progression          of HIV disease or related conditions. Determining HLA type is also necessary to be able          to perform certain research studies.        -  Tonsillar biopsy: Examination of tonsil tissue may provide information on the effects of          IL-2 on the immune system and the expression of HIV. Patients in the randomized IL-2          study (93-CC-0113) may have tonsillar biopsies done up to three times-soon after          enrollment, after month 4, and after month 12. Patients in the open IL-2 study          (91-CC-0143) would have procedures no more often than every 3 months, with the following          exception: patients in either study who are willing to have repeat biopsies performed          during IL-2 therapy will have the procedure done up to three times during a round of          IL-2: before Il-2 therapy, day 2-3 or IL-2 therapy, and day 4-6 of IL-2 therapy, if the          sequential biopsies can be safely performed. The area to be biopsied will be numbed with          a local anesthetic and 1 to 2 small pieces of tissue will be biopsied.        -  Skin biopsy: Examination of skin tissue may help to explain how IL-2 causes changes in          the skin. Biopsies will be obtained from areas of the skin that have been affected by          IL-2 as well as from normal, unaffected areas for comparison. Patients with Kaposi          sarcoma will also have biopsies of normal skin to allow comparison with IL-2-induced          changes in the Kaposi sarcoma lesions. The areas to be biopsied will be numbed with          local anesthetic and a 2-mm (1/10th-inch) piece of skin will be biopsied from each site.   "
161899|NCT00001506|"     This is a training, natural history of disease, and screening protocol for the evaluation,     treatment and follow-up of patients with dermatologic diseases and systemic diseases with     cutaneous manifestations. Patients enrolled in this protocol will be evaluated and treated     according to generally available, standard procedures and therapeutic modalities. Samples of     blood and skin will be studied by routine and specialized investigative methods to establish     these patients' diagnosis, response to treatment, and/or disease progression.   "
161900|NCT00001507|"     This study will evaluate the effectiveness of combination chemotherapy with paclitaxel     (Taxol) and cyclophosphamide (Cytoxan), followed by high-dose melphalan and etoposide for     treating inflammatory breast cancer. Patients also receive infusions of their own previously     collected progenitor cells (primitive cells that can make new cells to replace ones destroyed     by chemotherapy).      Patients 18 years of age or older with stage IIIB inflammatory breast cancer that has not     metastasized (spread beyond the breast) may be eligible for this study. Candidates are     screened with a medical history and physical examination, blood and urine tests, and chest     x-ray. They have computed tomography (CT) of the head, chest, abdomen and pelvis as well as a     bone scan to determine the extent of disease, and a nuclear medicine scan called MUGA to     examine the heart's pumping ability. They may receive a rehabilitation medicine evaluation.      Participants undergo the following tests and procedures:        -  Central venous line placement: Patients have a central venous line (plastic tube) placed          into a major vein in the chest before beginning treatment. The line remains in the body          throughout treatment and is used to give chemotherapy and other medications and to          withdraw blood samples. The line is usually placed under local anesthesia in the          radiology department or the operating room.        -  Chemotherapy: Patients receive two or more cycles of paclitaxel and cyclophosphamide.          Paclitaxel is given intravenously (I.V., through a vein) for 72 hours using a portable          pump. Cyclophosphamide is given daily for 3 days I.V. over 1 hour. The cycles may be 28          days apart. A drug called Mesna is given with this treatment to protect the bladder from          irritation from cyclophosphamide. Patients who have not previously been treated with          doxorubicin (Adriamycin) may receive a maximum of four cycles of doxorubicin and          cyclophosphamide by vein on a single day during each cycle, with cycles 21 days apart.          When all the paclitaxel/cyclophosphamide cycles are completed, patients receive          melphalan and etoposide, both drugs I.V. over 1 to 8 hours for three consecutive days.        -  G-CSF treatment: After each paclitaxel/cyclophosphamide cycle and after the          melphalan/etoposide treatment, patients are given a drug called G-CSF. G-CSF, injected          under the skin, stimulates production of infection-fighting white blood cells.        -  Apheresis: This is a procedure to collect progenitor cells for later reinfusion. For          this procedure, blood is collected through a catheter (plastic tube) placed in an arm          vein. The blood is circulated through a cell-separating machine, where the white cells,          including the progenitor cells, are extracted, and the red cells are returned to the          patient through another catheter in the other arm. Apheresis is done after each of two          cycles of paclitaxel/cyclophosphamide.        -  Progenitor cell transplant: Progenitor cells are reinfused after melphalan/etoposide          treatment.        -  Glucose infusion: A salt solution with chemically modified glucose is infused I.V. over          a period of from 12 to 48 hours, with subsequent donation of blood cells for blood and          immune system studies. Patients have a maximum of two glucose infusions, separated by at          least 3 months.        -  Tumor biopsy: Some patients have a biopsy of their tumor (removal of a small piece of          tumor tissue for microscopic study) before starting chemotherapy.        -  Blood tests: Blood is drawn frequently to monitor safety and treatment response, and for          research purposes.        -  Dental consultation: Some patients may have a dental consultation before the progenitor          cell transplant.   "
161799|NCT00001355|"     This protocol is designed to evaluate selected patients with documented recurrent or unusual     infections and their family members for clinical and laboratory correlates of immune     abnormalities. It allows long term follow up of patients with host defense defects and     permits the periodic study of their blood, urine, saliva, skin, stool and vaginal specimens     or wound drainage from such patients or their family members for medically indicated purposes     and research studies related to understanding the genetic and biochemical bases of these     diseases. This protocol may help provide patients and materials for the development of     therapies for these diseases.      This study will:        1. Determine the biochemical and genetic causes of inherited immune diseases affecting          phagocytes (white blood cells that defend against bacterial and fungal infections)        2. Try to develop better ways to diagnose and treat patients with these diseases, and to          prevent, diagnose and treat their infections      Patients and family members may undergo the following procedures:        -  A personal and family medical history, physical examination and other procedures, which          may include various blood tests; urinalysis; saliva collection; imaging studies such as          chest X-ray, computed tomography (CT) or magnetic resonance imaging (MRI); and lung          function studies, dental examination or eye examinations, if medically indicated.        -  Patients who have draining wounds will have fluid collected from these wounds for          biochemical study.        -  Tissues removed as part of medical care, such as pieces of lung, liver, or teeth, or          biopsies of these tissues will be studied.        -  Patients who have an immune problem that investigators wish to study further will be          asked to return to NIH for follow-up visits at irregular intervals, but at least every 6          months. The visits will include an updated medical history, examination directed at the          particular medical problem related to the immune disorder, follow-up of abnormal tests          or treatment, and collection of blood, saliva, urine, or wound fluid for study.        -  Patients may have genetic testing and must be willing to have specimens stored for          future research.        -  Family members will have a medical history, saliva or urine collection, and chest X-ray          or other imaging study, if medically indicated.        -  Normal volunteers who have had tissue biopsies or pieces of tissue removed as part of          medical care, such as pieces of lung, liver, or teeth, will have these tissues studied.        -  NIH does not cover the cost of the initial screening visit for travel or lodging. A          financial assessment may determine if the patient is eligible for financial assistance.          This study does not enroll children under the age of 2.        -  Patients will be asked to obtain their medical records, previous test results, or          imaging studies prior to the first visit.   "
161800|NCT00001356|"     This study will determine what growth factors are involved in promoting and inhibiting     mastocytosis-an abnormal increase of mast cells in one or more organ systems. Mast cells     release chemicals that can cause itching, blisters, flushing, bone pain, and abdominal pain.     Little is known about the disease and there is no cure. Steroids and antihistamines can help     reduce some symptoms.      Patients from birth to 80 years of age with increased mast cells in at least one organ system     may be eligible for this 3-year study. Family members may also be enrolled for genetic     testing.      Patients will be evaluated yearly at the NIH Clinical Center with the following tests and     procedures:        -  Medical history and physical examination.        -  Blood samples.        -  Laboratory blood tests, as medically indicated.        -  Bone marrow aspiration and biopsy - For the bone marrow aspiration and biopsy, the back          hipbone is punctured with a sterile needle. Five milliliters (1 teaspoon) of marrow is          withdrawn through a syringe and a 1/2-inch piece of tissue is extracted with a special          needle.      The blood and bone marrow samples will be used for clinical care and for research to     determine if mastocytosis is due to mast cell growth factors or genetic changes.      Patients who require further evaluation and tests will have recommendations made to their     primary physician. Any patient who requires immediate treatment will be admitted to the     hospital. Standard medical treatment may include antihistamines for itching; steroids for     severe abdominal symptoms such as cramping, diarrhea, and evidence of increased mast cells     determined by an upper GI study; and adrenaline for anaphylactic shock. Patients who do not     respond to conventional treatment may be offered participation in an experimental therapy     study.      Participating family members will have a medical history and a blood sample drawn to look for     genetic abnormalities.   "
161801|NCT00001387|"     The objective of this trial is to determine the maximum tolerated dose and the toxicities of     paclitaxel given as a short hour infusion in children with refractory malignancy.   "
161802|NCT00001390|"     Saliva is critical in maintaining oral health and comfort. Our laboratory has investigated     several disorders of salivary glands. The purpose of this protocol is to obtain data from     healthy volunteers for comparison with data from patients with salivary dysfunction. We plan     to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid     participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits     that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry     eye examination, and lip biopsy follow up, as needed. These are routine diagnostic     procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro     biochemical analysis or in vivo transplantation.      Some of the Healthy Volunteers may be asked to participate in an MRI study of the salivary     glands.   "
161833|NCT00001426|"     A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human     ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for     8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration     causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and     continuous exposure is needed. This study will evaluate the combination of continuously     administered CAI with three-weekly paclitaxel.   "
161834|NCT00001427|"     The objectives of this study are to determine the response rate to 9-AC in patients with     advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based     chemotherapy regimens.   "
161803|NCT00001391|"     Deficient or inappropriate healing of bone impacts clinical decision-making and treatment     options in orthopedics, oral and maxillofacial surgery, plastic surgery and periodontics.     While a number of auto- and allografting techniques have been used to regenerate craniofacial     defects caused by infective, neoplastic or trauma-induced bone loss, each method has     significant limitations. Our research group in the Craniofacial and Skeletal Diseases Branch     of NIDCR has developed methods to culture and expand cell populations derived from mouse bone     marrow stroma. We believe that an important next step is to apply the information gained in     animal studies to treat osseous defects in humans. We propose to examine the potential of     cultured human bone marrow stromal cells to serve as an abundant source of osteoblastic     progenitor cells. These cells will ultimately be used to graft craniofacial osseous defects.     In the course of this study we will: (1) develop methods for the propagation and enrichment     of osteoblastic progenitor cells from bone marrow stroma; (2) test various vehicles for the     transfer of bone marrow stromal cells to osseous defects in recipient animals; (3) determine     optimal culturing and transplantation conditions for the eventual transplantation of bone     marrow stromal cells into human recipients. These studies will define the parameters of bone     marrow stromal cell transplantation and will generate models for future therapeutic     strategies.   "
161839|NCT00001435|"     Children and adolescents with HIV/AIDS are living well beyond life expectancy that was     projected for them in the recent past. Little is known about the psychosocial variables that     coincide with long-term survival of HIV/AIDS. This longitudinal study examines the     psychosocial factors and adaptive coping strategies associated with long-term survival of     HIV/AIDS in children and how these factors change over a period of two years. In addition,     data is being collected from the primary caretakers on their own psychological well-being as     will as their perceptions of their child's adjustment and coping. Participants include     children who have been infected (either perinatally or through transfusion) for at least     eight years and who were aware of their diagnosis.   "
162227|NCT00002097|"     To evaluate the clinical toxicity, safety, and maximum tolerated dose (MTD) of intravenous     nystatin in patients with HIV infection. To evaluate the potential anti-HIV activity and     clinical pharmacology of intravenous nystatin.   "
161804|NCT00001392|"     The present protocol seeks to advance our understanding of sclerosing glomerular and     tubulointerstitial kidney diseases, including but not limited to variants of focal segmental     glomerulosclerosis (FSGS) and chronic kidney disease of unknown etiology (CKDu). This     protocol will encompass studies of the natural history, pathogenesis and treatment of these     chronic kidney disorders. It will also allow us to: (1) provide second opinions to referring     physicians about management of subjects with these relatively rare kidney diseases; (2)     collect research samples (e.g., blood), urine, and kidney tissue obtained from     clinically-indicated or from research renal biopsies); (3) and treat these subjects with     standard or other approved therapies; or (4) invite selected subjects patients to participate     in limited pilot studies of novel combinations of standard therapeutic agents, such as     rituximab and cyclosporine. (5) Agricultural worker chronic kidney disease of undetermined     etiology (CKDu) is a growing problem in tropical countries in the Americas and Asia,     including Sri Lanka where collaborators are located. We will receive kidney tissue from 25     CKDu cases for pathologic examination and transcriptional profiling and blood, plasma, serum,     urine for metabolomic and genetic analysis from 50 cases and controls. Subjects were     consented and samples were collected under a protocol approved by the University of Colombo     IRB. These studies may provide the opportunity to generate new hypotheses regarding     pathogenesis and treatment that would be candidates for testing in other research protocols.      Subjects with known or suspected forms of sclerosing glomerular or chronic, fibrosing     tubulointerstitial kidney diseases will undergo routine medical evaluation, laboratory     testing, imaging procedures and kidney biopsies as medically indicated. Selected subjects     will be invited to provide informed consent to undergo a kidney biopsy for research purposes.     Blood, urine, and tissue samples will be evaluated both for standard diagnostic purposes and     for research purposes using specialized molecular methods that may provide insights into     specific disease pathogenesis. Subjects may elect to receive the results of their kidney     disease evaluation, NIH treatment recommendations, and return to the care of their referring     physicians. Other subjects may be treated with either conventional or approved agents, or     (with separate consent) with a novel combination of conventional therapies (rituximab and     cyclosporine) as part of pilot studies that would involve long-term follow-up care at the     NIH.   "
161805|NCT00001393|"     Glomerulonephritis is a disease which affect the kidneys. Occasionally these diseases can     progress to a loss of kidney function in some patients. Glomerulosclerosis or focal segmental     glomerulosclerosis (FSGS) is one form of glomerulonephritis.      The cause of FSGS is unknown and often occurs on its own (idiopathic), or it can be     associated with HIV (Human Immunodeficiency Virus). FSGS occurs more commonly among black     patients than Caucasian or Hispanic patients. Researchers believe that environmental factors     may interact with genetic mutations to cause FSGS, at least in some patients.      This study will attempt to identify genetic factors associated with the development of FSGS.     The study population will be made up of 600 total subjects divided into 3 groups. Group one     will be 200 African-Americans with FSGS. Group two will be 200 African-Americans with HIV but     without FSGS. Group three will be 200 non-African-Americans with FSGS.      Study participation requires that researchers obtain 20 ml (2 tubes of blood). The genetic     material (DNA) will be prepared from the white blood cells and analyzed. The results of each     group will be compared with the results from the other groups to determine if one or more     genes predisposes to FSGS. In the long run, studies that demonstrate a genetic basis for FSGS     may help us identify patients earlier and may lead to improved therapies....   "
161806|NCT00001394|"     Occasionally tumors of the parathyroid gland cannot be detected by standard x-ray diagnostic     procedures (CT scans, MRIs, and ultrasounds). In order for the tumor to be removed surgically     it must first be localized. To do this often requires a procedure known as parathyroid     arteriography and parathyroid venous sampling.      This procedure begins by placing a catheter through a blood vessel in the groin. The catheter     is then guided through blood vessels to reach the area of the neck. The blood vessels in this     region flow in and out of the thyroid and parathyroid. An X-ray dye is then injected through     the catheter into the arteries of the thyroid/parathyroid (parathyroid arteriography). The     alternative is taking a small sample of the veins found in this same region (parathyroid     venous sampling).      Researchers prefer parathyroid arteriography because it causes less discomfort to the patient     and requires less experience to do the procedure. However, parathyroid arteriography provides     positive results in only 50% of patients undergoing the procedure. Parathyroid venous     sampling provides greater amounts of positive results but the readings are often imprecise.     Parathyroid tissue secretes a hormone known as PTH (parathyroid hormone). The release of PTH     is stimulated by low levels of calcium in the blood.      The idea behind the study is to inject a dye into the area of the parathyroid that will cause     a release of PTH. Several parathyroid venous samplings will be taken following the abrupt     elevation of PTH. This will provide information on the effectiveness of an intraarterial     hypocalcemic stimulus (injection of dye into the arteries of the parathyroid when calcium     blood levels are low) and venous sampling as techniques to improve localizing parathyroid     tumors.   "
161835|NCT00001428|"     This protocol will evaluate the activity of 5-Fluorouracil (FUra) given as a 1 hour infusion     in combination with leucovorin (LV) and interferon IFN alpha-2a in patients with advanced,     measurable colorectal cancer.   "
161994|NCT00000985|"     To compare the safety and effectiveness of foscarnet and vidarabine treatments for AIDS     patients who have herpes simplex virus infections that are resistant to standard treatment     with acyclovir.      Foscarnet is a drug that inhibits viruses and has been shown to be effective against     infection with Cytomegalovirus and also against infection with the Herpes simplex virus in     several patients with AIDS. Vidarabine has been shown to have activity against the Herpes     simplex virus in patients who do not have AIDS, but it has not been studied in patients who     do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who     have herpes simplex infection that has not responded to therapy with acyclovir in the hope     that one of these two drugs will help to stop further progression of the herpes simplex     infection and may have fewer side effects.   "
161813|NCT00001402|"     The human heart is divided into four chambers. One of the four chambers, the left ventricle,     is the chamber mainly responsible for pumping blood out of the heart into the circulation.     Diseases of the heart like congestive heart failure (CHF), can cause the left ventricle to     function improperly.      Medications called beta-blockers appear to reverse the abnormalities in the left ventricle     and frequently improve the function of the left ventricle in patients with different kinds of     heart disease. How beta-blockers improve left ventricle function is unknown.      One possible reason for improved function of the left ventricle with beta-blockers is     improved blood flow to the heart muscle. When a region of the heart is active, it uses more     fuel in the form of oxygen and sugar (glucose). As heart activity increases, blood flow to     and from the area of activity increases also. Knowing these facts, researchers can use     radioactive sugar (glucose) and positron emission tomography (PET) scans to observe what     areas of the heart are receiving more blood flow.      In this study researchers plan to measure glucose use in heart muscle and blood flow to the     heart muscle in patients with CHF taking beta-blockers.   "
164394|NCT00004806|"     OBJECTIVES:      Evaluate the efficacy and safety of lipid-mediated transfer of the cystic fibrosis     transmembrane conductance regulator gene to nasal epithelium in patients with cystic     fibrosis.   "
161807|NCT00001395|"     The efficacy of laser photocoagulation treatment for diabetic retinopathy has been     demonstrated by several National Eye Institute (NEI) sponsored clinical trials. The Diabetic     Retinopathy Study (DRS) demonstrated that scatter photocoagulation reduces the risk of     blindness from diabetic retinopathy. The Early Treatment Diabetic Retinopathy Study (ETDRS)     extended these findings by providing information on when to initiate scatter photocoagulation     and by demonstrating that focal treatment was effective in treating macula edema. The Krypton     Argon Regression Neovascularization Study (KARNS) showed that scatter photocoagulation with     krypton red laser was just as safe and effective as the argon blue-green laser in the     treatment of proliferative diabetic retinopathy.      Unfortunately, there is little data on the long term effects of photocoagulation on visual     function. The first objective of this study is to assess the long term effects of     photocoagulation for diabetic retinopathy. A second objective is to provide additional     information on the risk of progression of cataracts in persons with diabetes. All patients     previously treated with laser photocoagulation (focal and/or scatter) are eligible to     participate in this long term study. The first priority will be given to patients who     participated in the ETDRS and KARNS because of the wealth of information available regarding     the details of their treatment and course after treatment. Study evaluations will include a     standard ophthalmic examination, fluorescein angiography, lens and fundus photography.   "
161808|NCT00001396|"     Several studies have shown that specialized pacemaking devices (DDD pacing) can improve the     symptoms associated with hypertrophic cardiomyopathy (HCM) in adults. In addition, studies     have also shown that specialized pacemaking devices (DDD pacing) can improve conditions of     HCM in children. However, growth of the body and organs, including the heart, is very rapid     during childhood. Therefore the long-term effects of DDD pacing in children are unknown.      The purpose of this study is to examine the growth rate and nutrition of children with HCM.     Due to this heart condition and the restrictions that are often placed on the child's     activity level, children with HCM may grow at a slower rat and may have a greater tendency to     be overweight.      Children participating in the study will have their growth rate and nutritional status     measured before the study begins and throughout the course of the study.      Findings in this research study will not directly benefit the patients participating in it.     However, information gathered as a result of this study may lead to improvements in the     management of children with HCM in the future.   "
161809|NCT00001397|"     This study is designed to allow the evaluation, follow-up, and medical care of patients with     blood disorders not currently participating in a research study being conducted by the     Hematology Branch of the National Heart, Lung and Blood Institute (NHLBI) or not being     screened for participation in a study.      The purpose of this study is to allow investigation into the blood disorders of patients in     order to teach, learn, and gather more information about diseases of the blood.      In addition, this study allows researchers the opportunity to evaluate patients referred to     the Hematology Branch of the NHLBI with rare or undiagnosed diseases of the blood. This may     be potentially beneficial to the patient and at the same time contribute to the development     of new research ideas.   "
161810|NCT00001398|"     This trial, sponsored by Amgen, Inc., which produces the recombinant methionyl human stem     cell factor (r-metHuSCF), also involves two other institutions. The primary objective is     determination of the safety of administering multiple doses of r-metHuSCF in the setting of     acquired aplastic anemia and evaluation of the effect of r-metHuSCF on peripheral blood     counts. Potential effects of r-metHuSCF on frequency of need for red cell or platelet     transfusions and on bone marrow morphology/cellularity will also be evaluated.   "
161811|NCT00001399|"     Fanconi's Anemia is an inherited disorder that can produce bone marrow failure. In addition,     some patients with Fanconi's anemia have physical defects usually involving the skeleton and     kidneys. The major problem for most patients is aplastic anemia, the blood counts for red     blood cells, white blood cells, and platelets are low because the bone marrow fails to     produce these cells. Some patients with Fanconi's anemia can develop leukemia or cancers of     other organs.      Many laboratory studies have suggested that Fanconi's anemia is caused by an inherited defect     in the ability of cells to repair DNA. Recently, the gene for one of the four types of     Fanconi's anemia, type C, has been identified. It is known that this gene is defective in     patients with Fanconi's anemia type C.      Researchers have conducted laboratory studies that suggest Fanconi's anemia type C may be     treatable with gene therapy. Gene therapy works by placing a normal gene into the cells of     patients with abnormal genes responsible for Fanconi's anemia type C. After the normal gene     is in place, new normal cells can develop and grow. Drugs can be given to these patients kill     the remaining abnormal cells. The new cells containing normal genes and will not be harmed by     these drugs.      The purpose of this study is to test whether researchers can safely place the normal     Fanconi's anemia type C gene into cells of patients with the disease. The gene will be placed     into special cells in the bone marrow called stem cells. These stem cells are responsible for     producing new red blood cells, white blood cells, and platelets.   "
161812|NCT00001400|"     This study is designed to screen patients with heart diseases who may qualify to participate     in other research studies being conducted by the Cardiology Branch of the National Heart,     Lung, and Blood Institute (NHLBI).      Patients participating in this research study will be seen on an outpatient basis and undergo     a general medical evaluation, including blood tests, urine, examination, chest x-ray and     electrocardiogram (EKG). In addition, patients may be asked to have an echocardiogram     (ultrasound scan of the heart) and to perform an exercise stress test.      Patients participating in this study will not receive any investigational treatments.   "
161836|NCT00001430|"     This is a randomized study of combination chemotherapy (EPOCH II) versus EPOCH II and     immunotherapy with peripheral blood stem cells (PBSC) and IL-2 in patients with relapsed     Hodgkin's and non-Hodgkin's lymphomas, and untreated patients with low-grade non-Hodgkin's     lymphomas. The chemotherapy entails the administration of multiple cycles of infusional     doxorubicin, etoposide and vincristine chemotherapy (total of 3), alternating with cycles of     high-dose cyclophosphamide (3 cycles). Patients will be randomized, on a 2:1 basis, to either     receive only chemotherapy or to undergo a PBSC harvest with PBSC reinfusion and IL-2     following the last cycle of chemotherapy. In all patients, immunological monitoring for     NK/LAK activity, T cell number and function will be performed. The therapy is specifically     targeted for patients who would be candidates for high-dose chemotherapy with stem cell     support.   "
161814|NCT00001403|"     This study will examine rare congenital disorders that involve malformations and abnormal     growth. It will focus on patients with Proteus syndrome, whose physical features are     characterized by overgrowth, benign tumors of fatty tissue or blood vessels, asymmetric arms     or legs, and large feet with very thick soles. The study will explore the genetic and     biochemical cause and course of the disease, the changes in symptoms over time, and the     effects of the disease on patients.      Patients with Proteus syndrome and their parents may be eligible for this study. Parents will     be studied, when possible, for comparison of molecular findings. Study candidates will have a     medical history and physical examination, including X-rays and possibly other imaging tests,     such as computerized tomography (CT), magnetic resonance imaging (MRI) and ultrasound. Other     tests and examinations may be done if needed.      Those enrolled in the study will have will be interviewed or complete questionnaires, or     both, about how their disease affects them. (Parents will be asked about their feelings about     having a child with a rare disorder.) Patients will provide a small blood sample for research     and may be asked to undergo biopsies from a normal area of skin and from a tumor.   "
161815|NCT00001404|"     We aim to delineate the range of severity, natural history, molecular etiology, and     pathophysiology of Pallister-Hall syndrome (PHS), Greig cephalopolysyndactyly syndrome     (GCPS), McKusick-Kaufman syndrome (MKS), Bardet-Biedl syndrome (BBS), Oro-facial digital     syndromes (OFDs), and other overlapping phenotypes. These disorders comprise a syndrome     community of overlapping manifestations and we hypothesize that this is a reflection of a     common mechanistic pathway. This hypothesis be addressed by a combined clinical-molecular     approach where we bring up to 50-100 patients with each disorder to the NIH clinical center     for a comprehensive clinical evaluation with follow-up at a frequency appropriate to the     disorder. Specimens will be collected and evaluated in the laboratory by linkage analysis,     physical mapping, candidate gene characterization, mutation screening, and cell biologic     studies of normal mutant proteins.   "
161816|NCT00001405|"     This protocol is designed to study the techniques needed to develop gene therapy or other     treatments for certain inherited immune system diseases.      Healthy normal volunteers between 18 and 65 years of age and patients with chronic     granulomatous disease (CGD), X-linked severe combined immune deficiency (X-SCID), leukocyte     adhesion deficiency (LAD), interferon gamma receptor deficiency (IGR-deficiency) or other     inherited diseases affecting precursor blood cells-bone marrow cells that generate blood     cells-may be eligible for this study. Patients who have had repeated severe infections     possibly due to an inherited blood cell abnormality may also participate. Candidates will be     screened with a medical history, physical examination and blood tests.      Patients with an active infection will be hospitalized during this study. Uninfected     participants will be seen as outpatients at the NIH Clinical Center. Participants will have     the following procedures:        -  G-CSF administration All participants will have daily injections of granulocyte-colony          stimulating factor (G-CSF). This drug is a genetically engineered hormone that          stimulates the bone marrow to release white blood cells and white cell precursors into          the bloodstream. The injections are given under the skin in the arm or leg, using a very          small needle. Patients will have injections for 6 or 7 days, normal volunteers for 5. A          small blood sample will be drawn each day of the injections to monitor white cell counts          and changes in the number of blood cell precursors. (Smaller children and all children          under 10 years of age may have blood drawn on alternate days or less to reduce the          number of needle sticks and the amount of blood taken.). Larger blood draws will be          taken on days 6 and/or 7 for patients and on days 5 and/or 6 for normal volunteers.        -  Leukapheresis This procedure for collecting larger numbers of circulating blood          precursor cells is optional and may take the place of the larger blood draw described          above. Patients 5 years old or older may have leukapheresis. Whole blood is collected          through a needle in an arm vein. The blood circulates through a machine that separates          it into its components. The desired cells are then removed and the rest of the blood is          returned to the body, either through the same needle or through a second one placed in          the other arm. The cells obtained will be used to purify blood precursors for growing in          culture and to examine the ability to transfer new genes into these precursor cells. For          patients whose arm veins are too scarred to for needle placement, a vein in the groin          area (femoral vein) may be used instead.        -  Bone marrow aspiration - This procedure for obtaining a bone marrow sample is optional.          Normal volunteers who agree to the procedure may undergo aspiration up to three times.          The hip area is anesthetized and a small sample of bone marrow is drawn through a          special needle inserted in the hipbone. The first aspiration is done on a day before the          G-CSF injections are started; the second is done soon after the last injection (day 6 or          7), and the third is done from 7 to 10 days after the last injection.        -  Repeat blood tests - At day 6 or 7 some of the blood tests done at the beginning of the          study will be repeated to check blood counts and liver and kidney function.      Four months or more after the end of the study, participants will be asked to repeat the     entire procedure to examine the effects of two cycles of G-CSF mobilization in the same     individual. This second cycle is optional.   "
161817|NCT00001406|"     This study will investigate how, why and under what conditions eosinophils (a type of white     blood cell) become activated and will examine their function in immune reactions. Eosinophil     counts often rise in response to allergies, asthma, and parasitic worm infections. They can     also go up in uncommon autoimmune conditions and, rarely, in association with tumors.     Elevated levels of these cells is called eosinophilia. Usually, eosinophilia causes no     apparent symptoms, but in rare cases there may be local swelling and itching, allergic lung     problems, heart disease or nerve damage caused by the release of toxic substances in these     cells into body tissues.      Patients 1 to 100 years of age with eosinophil counts greater than 750/ml or an abnormal     accumulation of eosinophils in the skin or body tissues may be eligible for this study. All     participants will have a thorough medical history, physical examination and blood tests.     Depending on the person's age and symptoms, other diagnostic tests may be done, including     specialized studies of the eye, lungs, skin, bone marrow, nerves or heart. This is not a     treatment study, and no experimental treatments will be offered. Patients who require     treatment will receive standard medical care.      Certain other procedures may be requested solely for research purposes. All participants will     be asked to donate extra blood for laboratory studies investigating how immune cells and     other immune substances in the blood act to stimulate a rise in eosinophils. In addition,     some participants may undergo one or more of the following:        -  <TAB>Annual Follow-up evaluations - Physical examinations and blood tests to evaluate          changes in the patient's condition and eosinophil counts over time.        -  <TAB>Bone marrow biopsy and aspiration will be recommended during the initial          evaluation, and in certain patients at other times when it is important to look directly          at the newly developing cells in the bone marrow. For this procedure an area of skin and          bone is anesthetized with xylocaine (an anesthetic similar to that used by dentists),          and a very sharp needle is used to sample the bone marrow for evaluation. Bone marrow          biopsy and aspiration can have side effects of pain and/or bleeding into the skin and          soft tissues at the site of the procedure. Rarely the area at the biopsy site can become          infected, and is treated with antibiotics.        -  <TAB>Genetic testing: Some of the blood drawn from you as part of this study will be          used for genetic tests. Genetic tests can help researchers study how health or illness          is passed on to you by your parents or from you to your children. Any genetic          information collected or discovered about you or your family will be confidential.        -  <TAB>Leukapheresis (only patients 18 years and older) to collect large numbers of          certain cells - In this procedure, whole blood is collected through a needle placed in          an arm vein. The blood circulates through a machine that separates it into its          components. The white cells are then removed and the rest of the blood is returned to          the body, either through the same needle used to draw the blood or through a second          needle placed in the other arm....   "
161818|NCT00001407|"     This study will determine what dose of recombinant interferon-gamma is safe and effective for     treating multiple drug-resistant tuberculosis. Recombinant interferon-gamma is a genetically     engineered form of a substance normally produced by the body and is used to boost immune     function.      Patients 5 years of age and older with multiply drug-resistant tuberculosis may be eligible     for this study.      Participants will be admitted to either the NIH Clinical Center in Bethesda, Maryland, the     Texas Center for Infectious Diseases in San Antonio or the South Texas Hospital or Valley     Baptist Hospital, both in Harlingen, Texas. On admission, patients will have a medical     history, physical examination, blood and urine tests, sputum culture, X-rays, pulmonary     function tests and a computed tomography (CT) scan. CT produces 3-dimensional images of body     tissues and organs in small sections. For the procedure, the patient lies still on a table     surrounded by the scanner.      All patients will continue treatment with anti-tuberculosis antibiotics during and after the     study period and may elect whether or not to take gamma interferon in addition to the     antibiotic. Five patients will receive only antibiotic treatment, and 5 each will receive one     of 3 doses (0.025, 0.05 or 0.1 milligrams per square meter of body surface area) of     interferon-gamma injected under the skin 3 times a week. The patient or caregiver will be     taught to give the injections, which are similar to insulin injections for diabetes.      Patients will be in isolation in the hospital from the start of therapy until sputum samples     show no evidence of tuberculosis for 3 consecutive weeks. Following that, they will repeat     the tests done on admission (except CT) during follow-up visits (1- to 2-day     hospitalizations) at 3, 6, 9, 12, 15, 18 and 24 months after the start of therapy. Patients     taking interferon gamma will have blood drawn more frequently (monthly) for the first 6     months, and patients with lung infection will have sputum samples collected more     frequently-weekly for the first 3 months or until three consecutive negative samples are     obtained and then monthly throughout the course of therapy. Patients with lung infection will     also have repeat CT scans at 6 and 12 months while on interferon gamma. In one or two     patients on the drug, blood will be drawn frequently following one injection of gamma     interferon (just before the injection and again at 0.25, 0.5, 1, 6, 12, 18, 24 and 48 hours     after it) to see if a difference in blood levels of the drug can be detected.   "
161819|NCT00001408|"     This study will examine the movement of T cells (a type of white blood cell) from the blood     to the lungs in patients with asthma after exposure to an allergen, such as cat dander or     pollen. Asthma is in large part due to inflammation of the bronchi (the breathing tubes of     the lungs), causing heat, swelling and redness. T cells play a major role in the inflammatory     reaction. A better understanding of T cell migration to the lungs after allergen exposure may     lead to improved therapies for asthma.      Patients between 18 and 50 years of age with mild allergic asthma may be eligible for this     study. In addition, patients and healthy normal volunteers between 18 and 65 years of age may     participate in a sub-study (blood draw) of this protocol. Participants will undergo the     following procedures:      Visit 1 (screening visit)        -  Blood tests for blood counts and HIV        -  Urine pregnancy test for women of childbearing potential.      Visit 2        -  Physical examination and electrocardiogram (EKG)        -  Prick skin testing - A drop of allergen extract is put on the skin and the underlying          skin is scratched with a needle. A positive test resembles an insect bite and may itch.        -  Intradermal skin tests - Increasing concentrations of a drop of diluted allergen are          injected into the skin and the allergic response is monitored until a 5-mm swelling (1/4          inch) swelling develops.        -  Methacholine challenge - The subject has repeated pulmonary function (breathing) tests          after breathing methacholine, a drug that temporarily (for 5 to 10 minutes) worsens          asthma symptoms.        -  Physician evaluation and repeat pulmonary function test      Visit 3      - Allergen bronchoprovocation - This test will be done in patients whose physical evaluation     and breathing test permit them to continue with the study. A heparin lock (needle device that     stays in a vein to allow multiple blood draws without repeated sticks) is placed. The subject     breathes 5 breaths of allergen through a nebulizer (device that creates a mist), followed by     a breathing test. This procedure will be repeated with increasingly higher allergen doses     until lung function significantly declines or for a maximum of 6 doses. Subjects are     monitored for 8 hours after the last dose. Blood samples of 50 ml each (3.5 tablespoons) are     collected at 1, 3, 5 and 8 hours, and a physician evaluation is done at the end of the 8     hours. Additional 50-mm blood samples are collected the following two mornings.      Visit 4        -  Physician evaluation, blood test for anemia and pulmonary function test        -  Serial blood draws - 50 ml of blood will be drawn, followed by salt-water nebulization          and another 50-ml blood draw after 1 hour. Additional 50-ml blood samples will be drawn          7 hours later and then on the next two mornings.      Participants in the sub-study portion of this protocol will undergo the screening blood test,     prick skin testing, breathing test after methacholine inhalation and a 100 ml-blood draw.     These tests will be done in three sessions.   "
161837|NCT00001431|"     Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation     using 4-15 MV photons; plus Gemcitabine, NSC-613327.   "
162288|NCT00002158|"     The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients     suffering from cryptosporidiosis (diarrhea caused by the parasite Cryptosporidium).   "
161838|NCT00001432|"     Allogeneic bone marrow transplantation (BMT) is a curative treatment for patients with     chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is     available as a treatment option to only a minority of patients. Autologous BMT, coupled with     high dose chemotherapy, is a treatment open to more patients and is a promising strategy for     the treatment of advanced solid malignancies. However, the development of potentially     curative marrow transplant alternatives requires an ability to provide a nonmalignant     hematopoietic stem cell population. In addition, the generation of hematopoietic stem cells     (HSC), and the determination of whether or not such HSC repopulate all of the cell lineage     subtypes following reinfusion are critical to understanding the biology and immunological     consequences of stem cell transplantation. An increased understanding of the kinetics of HSC     and lymphocyte repopulation post-BMT and the identification of donor cell populations that     mediate a graft versus leukemia (GVL) effect or graft versus host (GVHD) is critical to     therapeutic efficacy. In order to address these currently unmet objectives, normal volunteers     and volunteers with malignancies will undergo venipuncture and bone marrow aspiration with or     without prior [6,6-(2)H(2)] or [U-(13)C(9)]-glucose, infusion to provide cell populations     which will then be utilized for specific pre-clinical studies aimed at developing new     therapeutic alternatives for patients with CML and other lymphoid/hematologic malignancies.     An infusion of [6,6-(2)H(2)] or [U-(13)C(9)]-glucose prior to bone marrow and/or leukocyte     harvest, in some volunteers, will allow direct examination of the genesis and biology of stem     cells and leukocyte subpopulations. [6,6-(2)H(2)] or [U-(13)C(9)]-glucose, are     nonradioactive, stable isotopes of glucose which will label dividing cells during the time of     administration and is chemically identical to glucose, with no adverse side effects other     than those known for glucose.   "
161820|NCT00001409|"     Certain patients enrolled in NIH protocol 94-I-0206 at the Clinical Center may be eligible to     participate in one or more of the following new options:        -  Donor/recipient extension phase - Both the recipient (HIV-infected twin) and donor          (non-infected twin) will participate in this extension of the CD4-zeta gene therapy          study. It will evaluate the safety and activity of infusing gene-modified CD4+ cells as          well as the modified CD8+ cells.        -  Corticosteroid administration - A corticosteroid, such as prednisone, hydrocortisone or          prednisolone, will be added to the interleukin-2 (IL-2) regimen for preventing or          treating side effects of IL-2 such as fever and other flu-like symptoms.        -  Extended follow-up - A more intensive follow-up will be scheduled for patients with          substantial numbers of lymphocytes that harbor the CD4-zeta gene. Every 3 months,          participants will have blood tests and specialized tests of CD4 counts, HIV-1 viral load          and numbers of circulating cells containing the CD4-zeta gene every 3 months> the          frequency of follow-up visits may be reduced as time goes by.        -  IL-2 continuation - Participants will continue to receive periodic treatment with IL-2          to see how long the genetically modified cells persist in the bloodstream and to          evaluate the long-term response to IL-2.        -  Home treatment with interleukin-2 - Participants may receive future IL-2 treatment          cycles at home. Home treatment involves less frequent data and safety monitoring and no          medical evaluations at the Clinical Center except at the beginning of each cycle.   "
161821|NCT00001410|"     Gaucher disease is a lysosomal storage disease resulting from glucocerebroside accumulation     in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in     patients of all ages. The condition is marked by enlargement of the liver and spleen     (hepatosplenomegaly), low blood and platelet counts, and bone abnormalities. The condition is     passed from generation to generation on via autosomal recessive inheritance. There are     actually three types of Gaucher disease.      Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease     does not affect the nervous system. The symptoms of type I can appear at any age.      Type 2 Gaucher disease presents prenatally or in infancy and usually results in death for the     patient. Type 2 is an acute neuronopathic form and can affect the brain stem. It is the most     severe form of the disease.      Type 3 Gaucher disease is also neuronopathic, however it is subacute in nature. This means     the course of the illness lies somewhere between long-term (chronic) and short-term (acute).      Currently there is not a cure for Gaucher disease. Treatment for the disease has     traditionally been supportive. In some severely affected patients, bone-marrow transplants     have corrected the enzyme deficiency, but it is considered a high-risk procedure and recovery     can be very slow. Enzyme replacement therapy is another therapy option and has been approved     by the Food and Drug Administration (FDA) for use in type 1 patients.      PEG-glucocerbrosidase is a drug designed to clear out the accumulation of lipid     (glucocerebroside) from the blood stream. The drug is actually an enzyme attached to large     molecules called polyethylene glycol (PEG). The large molecules of PEG allow the enzyme to     remain in the blood stream for long periods of time. By modifying glucocerebrosidase with     PEG, it is believed that smaller doses will be required, meaning a reduction in cost for the     patient and more convenient administration of the drug. The purpose of this study is to     evaluate the effects and safety of enzyme replacement therapy using PEG- glucocerebrosidase     for the treatment of Gaucher disease.   "
161822|NCT00001412|"     There is evidence that suggests male sex hormones (androgens) play a significant role in     brain (central nervous system) functioning. In studies conducted with animals, researchers     have documented that male sex hormones (androgens) are associated with neurotransmitter     (serotonin) function, sexual behavior, aggression, and other non-reproductive behavior.     Similar findings have been seen in studies involving humans.      Androgens are thought to be involved in some neurologic conditions. Tourette's syndrome which     is seen more often in males than females has caused researchers to look more closely at the     effects of androgens on the brain.      This study is designed to examine the effects of testosterone on brain (CNS) activity by     first stopping testosterone release and then replacing it.      Researchers will evaluate mood, behavior, cognitive (mental) function, physiologic response     to serotonergic agonists and regional cerebral blood flow (r-CBF).      This study will attempt to answer the following questions;      1. Is a person's mental functioning a result of being male or female (gender) or a result of     the hormonal condition      3. Does the decrease of blood flow (r-CBF) to specific areas of the brain (prefrontal cortex)     in women whose ovaries are not releasing hormones (hypogonadal state) also occur in men      4. Will the mental rotation task better identify hormone (gonadal steroid) differences in     r-CBF      5. Do hormones directly influence the responsiveness of the hypothalamic-pituitary-adrenal     (HPA) axis      6. Does the hormonal state of a patient directly affect levels of chemicals and steroids in     the cerebrospinal fluid (CSF).   "
161823|NCT00001413|"     The purpose of this study is to examine calcium absorption and bone mineral density in women     with depression.      Research indicates that pre-menopausal women with depression have significantly lower bone     mineral density (BMD) than pre-menopausal women without depression. Although the mechanisms     of BMD loss are unclear, researchers believe that individuals with depression have impaired     calcium absorption. However, it is unknown whether the abnormal absorption is a result of     depression or a side effect of the drugs used to treat it. This study will compare calcium     absorption in women with depression and in healthy women without depression.      Participants in this study will be given two non-radioactive calcium isotopes. One can be     taken by mouth and the other must be injected. Participants will have the level of isotopes     in their urine measured to estimate true fractional calcium absorption (TFCA). Participants     may also have a dual X-ray absorptiometry (DEXA) scan to measure total body adiposity and     lean body mass.   "
161824|NCT00001414|"     Previous research involving families, twins, and adoption all support the idea that there is     a substantial heritable aspect to personality.      The goal of this research study is to determine how genetics influence heritable personality     traits. The work will focus on how genetics affect the chemical messengers which brain cells     use to communicate with each other (neurotransmitters).      The study involves collecting personality data and DNA samples from related individuals,     primarily male siblings and female siblings, but also including parents. Genetic tests     performed on these samples will continue to focus on variations in genes, which potentially     effect brain neurotransmission.      This research has the potential to advance knowledge of genetic influences on human behavior     that may be relevant both to normal personality and to psychopathology.   "
161845|NCT00001442|"     Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Irradiation of tumor and     involved nodes using 4-6 MV photons (brachytherapy allowed to boost primary tumor; electrons     allowed to boost posterior neck and massive adenopathy); plus Paclitaxel (Bristol-Myers),     Taxol, TAX, NSC-125973.   "
162170|NCT00002040|"     To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial     treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS     patients. Both newly diagnosed and relapsed patients are eligible. The effectiveness of     maintenance fluconazole therapy in sustaining a clinical cure in AIDS patients will also be     evaluated.   "
161826|NCT00001416|"     The purpose of this study is to examine how the skeleton responds to repeated doses of enzyme     replacement therapy in patients with type I Gaucher's disease who have had their spleens     removed.      Gaucher disease is a lysosomal storage disease resulting from glycocerebroside accumulation     in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in     adults but occurs most severely in infants, in whom cerebroside also accumulates in neurons.     Patients with Gaucher's disease experience enlargement of the liver and spleen and bone     destruction. The condition is passed from generation to generation through autosomal     recessive inheritance.      Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease     does not affect nerve cells. The symptoms of type I can appear at any age.      In this study patients will be divided into three groups. Each group will receive different     doses of enzyme replacement (Ceredase). In addition, two of the three groups will also     receive doses of a form of vitamin D (calcitriol). Researchers believe the groups receiving     vitamin D will have an improved response as compared to those patients only receiving enzyme     replacement.      Patients in each group who respond to enzyme replacement with increases in bone density will     be compared to the other treatment groups.   "
161827|NCT00001417|"     Tumors of the spine can be described as primary, meaning that the tumor originated from cells     normally found in the spine, or metastatic, cells from another area of the body that have     spread to the spine. Metastatic tumors are more common than primary tumors. Tumors of the     spine can press against the spinal cord and interfere with information traveling down from     the brain to the nerves of the spinal cord. As a result, patients with spinal tumors can     suffer from loss of movement and sensation within areas of the body below the tumor. In     addition, tumors of the spine are typically painful conditions.      Presently, the treatment of choice for spinal tumors is radiation therapy. However, many     tumors of the spine become resistant to radiation therapy. In addition, because the spinal     cord is often so close to the tumor it can be damaged by the radiation.      Absolute (100%) ethanol is commonly known as alcohol. It is the same kind of alcohol found     in alcoholic beverages. When pure alcohol is injected directly into a tumor it can destroy     cells and blood vessels. Because of this feature, researchers would like to test the     effectiveness of alcohol in treating patients with spinal tumors.      Researchers believe that intratumoral ethanol injection is a treatment worth studying more     closely because it is minimally invasive, has been proven to be an effective treatment for     other types of metastatic tumors, can be used repeatedly, and does not interfere with other     treatments such as surgery.      In addition to testing the effectiveness of intratumoral ethanol injection, this study will     attempt to determine the causes of pain associated with spinal tumors.   "
161828|NCT00001418|"     This study is designed to use PET scans in order to measure activity of the sympathetic     nervous system. The sympathetic nervous system is the portion of the nervous system that     maintains a normal supply of blood and fuel to organs during stressful situations.      PET scan or Positron Emission Tomography is an advanced form of an X-ray. It is used to     detect radioactive substances in the body. During this study researchers plan to inject small     amounts of the radioactive drug fluorodopamine into patients. Fluorodopamine is very similar     to the chemicals found in the sympathetic nervous system. It can attach to sympathetic nerve     endings and allow researchers to view them with the aid of a PET scan. One area of the body     with many sympathetic nerve endings is the heart. After giving a dose of fluorodopamine,     researchers will be able to visualize all of the sympathetic nerve endings involved in the     activity of the heart. In addition, this diagnostic test will help researchers detect     abnormalities of the nervous system of patient's hearts.   "
161829|NCT00001420|"     This study will examine the genetic and immune factors involved in the cause and development     of psoriatic arthritis-a disease of both the skin and joints. It will describe the medical     features and natural course of the disease and determine participants' eligibility for     experimental treatment protocols.      Patients with known or suspected psoriatic arthritis 5 years of age and older and their     relatives may enroll in this study. Patients will be evaluated with a medical history and     physical examination, electrocardiogram, blood tests and X-rays. Additional procedures may     include:        1. Leukapheresis-Collection of white blood cells for genetic analysis. Whole blood is          collected through a needle placed in an arm vein. The blood circulates through a machine          that separates it into its components. The plasma is removed and the cells are returned          to the body through a second needle placed in the other arm.        2. Skin biopsy-Removal of a small skin sample for microscopic analysis. An area of skin is          numbed with an anesthetic and one to three small circular portions (about 1/4 inch in          diameter) are cut and removed.        3. Joint aspiration-Removal of a small sample of synovial fluid (lubricating joint fluid).          An area of skin around the biopsy site is numbed with an anesthetic, and a needle is          inserted into the joint to pull out a small fluid sample.        4. Synovial needle biopsy-Removal of a small sample of synovial tissue (tissue lining the          joint). An area of skin around the biopsy site is numbed with an anesthetic and a large          needle is inserted into the joint. A smaller needle attached to a syringe is then placed          inside the larger needle and small pieces of synovial tissue are removed.        5. Genetic studies-Saliva and blood samples will be collected for gene testing. Saliva is          collected by rinsing the mouth with a tablespoon of salt water and spitting into a test          tube.      Patients will be followed once or twice a year and may be evaluated for participation in an     experimental treatment study.      Participating relatives of patients will fill out a brief medical history questionnaire and     provide a DNA sample (blood sample or tissue swab from the inside of the cheek).   "
161830|NCT00001421|"     This study will test the safety and effectiveness of the drug methimazole in treating     polymyositis and dermatomyositis-inflammatory muscle diseases causing weakness and muscle     wasting. Although it is not known what causes of these diseases, abnormal immune function is     thought to be involved. Recent studies indicate that methimazole, which has been used for     many years to treat thyroid disease, may alter immune activity by affecting the interaction     between white blood cells called lymphocytes and certain molecules on cell surfaces. This     study will examine the effects of methimazole on immune activity and muscle strength in     patients with inflammatory muscle diseases and evaluate the drug side effects.      Patients with polymyositis and dermatomyositis who have normal thyroid function may be     eligible for this study [age requirement?]. Candidates will undergo a history and physical     examination; blood and urine tests; chest X-ray; muscle strength testing, daily living skills     questionnaire, and speech and swallowing evaluation; magnetic resonance imaging of muscles;     and muscle biopsy (removal of a small piece of muscle tissue under local anesthetic). When     indicated, some candidates may also have cancer screening tests (for example, mammogram, Pap     smear), a lung function test to measure breathing capacity, or an electromyogram, in which     small needles are inserted into a muscle to measure the electrical activity .      Participants will take 30 mg of methimazole by mouth twice a day for 6 months. They will have     blood tests weekly for the first 2 weeks and then every other week for the rest of the study     to measure blood counts and liver and thyroid function. Blood will also be drawn for white     blood cell studies during the screening evaluation, at the beginning of therapy, 6 to 12     weeks after therapy starts, at the end of the 6-month treatment period, and 1 and 3 months     after therapy ends. Muscle enzyme and urine tests will be done once a month.. During drug     treatment, patients will have periodic physical examinations and blood and muscle function     tests to evaluate the response to therapy.   "
161831|NCT00001422|"     This is a placebo controlled study evaluating the role of fludarabine (a nucleoside analog     targeting both resting and proliferating lymphocytes) in the treatment of moderate to severe     psoriotic arthritis. Patients should have failed at least one disease modifying antirheumatic     drug.   "
162289|NCT00002159|"     To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive     or negative persons with blastomycosis or histoplasmosis.   "
161840|NCT00001436|"     The suppression of IGF-I and growth hormone may significantly alter the pathobiology of     osteosarcoma. SMS 201-955 pa LAR is a long acting analog of Somatostatin which inhibits the     pituitary release of growth hormone, reducing levels of circulating IGF-I . Additional data     on tamoxifen usage has also demonstrated a reduction in circulating IGF-I levels. The degree     of suppression of IGF-I and growth hormone will be determined at two dose levels of SMS     291-955 pa LAR. Tamoxifen will be added to two of the cohorts to determine if the additive     effects of tamoxifen and SMS 201-955 pa LAR will lead to additional reduction of circulating     IGF-I and growth hormone levels.      Arginine-stimulated GH tests to assess levels of growth hormone in the blood will be     administered pre-treatment evaluation up to three times, one time on weeks 2, 8, 16, 28, 40,     52, and one month post last dose of SMS 201-955 pa LAR.      The four cohorts for this study will receive 60 or 90 mg SMS 201-955 pa LAR injectable every     four weeks for up to 52 weeks. Two of the cohorts will receive 10 mg Tamoxifen on a daily     basis.   "
161841|NCT00001437|"     After initial assessment of their condition by specified clinical and laboratory parameters,     each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg     po TID). Objective and subjective response parameters will be re-assessed at the end of the     treatment and 8 weeks later for possible decay of response.   "
161842|NCT00001438|"     Patients with congenital or acquired immunodeficiencies are at an increased risk to develop     polyclonal or oligoclonal lymphoid malignancies. Some develop a lymphoproliferative disorder     that can follow a clinically aggressive course and may represent a pre-malignant lesion.     Although most of these lymphoproliferative disorders are of B-cell origin, T-cell or     non-B-non-T-cell processes have also been observed. The pathogenesis is only partially     understood.      In the case of pre-malignant conditions it is often difficult to know when and whether a     therapeutic intervention is necessary and a careful consideration of potential     treatment-associated morbidity is indicated. Therapies have ranged from influencing the     possible infectious etiology (by treating with acyclovir), decreasing the amount of     immunosuppression (in transplant patients), to the use of immunomodulatory agents, including     interferons and interleukins. Recent data have indicated that the use of differentiating     agents, such as the retinoids, might offer yet another treatment option. In the current study     we will try to get a better understanding of the pathogenesis and natural course of     lymphoproliferative disorders in immunodeficient children.      The study will have two parts: an initial observation period to obtain information on the     natural course of these disorders, and then a six month treatment period with the combination     of a differentiating agent (13-cis-retinoic acid was used until all-trans-retinoic acid     became available on 7/96) with an immunomodulatory agent (interferon-alpha2a, IFN-alpha2a).   "
161843|NCT00001439|"     This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid     peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be     administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is     designed to evaluate the toxicity, immunologic effects and potential therapeutic role of     repeated doses of gp100 peptide vaccines administered subcutaneously.      Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis     of melanoma-specific T cell precursor frequency prior to and after immunization.   "
161844|NCT00001440|"     The ability of chemotherapy to cure cancer, including breast cancer, has been limited by drug     resistant residual tumor cells remaining after chemotherapy that generally result in relapse.     Additional therapeutic strategies to eradicate these residual tumor cells are needed. The     augmentation of specific anti-tumor immune responses, such as those mediated by T-cells,     might represent such an additional strategy for the control or elimination of residual tumor     cells. This approach might be especially effective if T-cell mediated responses were enhanced     during both the period of T-cell repopulation that follows acute T-cell depletion and in the     setting of minimal residual tumor burden present after dose intensive chemotherapy. Such     chemotherapy is known to result in severe T-cell depletion. This pilot study has been     designed to examine the feasibility of combining dose intensive chemotherapy with     interventions aimed at the reconstitution of T-cell immunity. Metastatic or adjuvant breast     cancer patients who have received dose intensive chemotherapy will subsequently receive a     combination of autologous chemotherapy-naive T-cells, a patient-specific tumor antigen     vaccine, and recombinant human interleukin-2. These interventions will be assessed for their     ability to modulate T-cell number, T-cell function, and T-cell specificity during the period     of T-cell repopulation. Such modulation may result in the effective reconstitution of     generalized T-cell immunity with the generation of vaccine-specific anti-tumor T-cell     responses.   "
161846|NCT00001443|"     This is a phase I/II study to determine the safety and tolerance of the protease inhibitor     indinavir (MK-0639), alone and then in combination with HIV reverse transcriptase inhibitor     therapy in children with HIV infection. Indinavir sulfate (the capsule formulation) has been     shown to have potent antiviral activity and an acceptable safety profile in adults.     HIV-infected children who have not received prior antiretroviral therapy, and children who     have become refractory to prior therapy, or who have experienced toxicity to prior therapy,     will be included. In addition, we will explore viral and CD4 cell kinetics before starting     therapy and following exposure to antiretroviral agents.      The study will be conducted in three parts.        1. In order to help interpret the antiviral activity of indinavir, the virologic and          immunologic profile of children will be studied within 2 weeks prior to starting the          therapeutic part. For children who have never been treated, this will be before the          initiation of any antiretroviral therapy and for children who have already received          antiretroviral therapy, this will be done during the initial wash-out phase that is          routinely interposed between two different treatment regimens.        2. The initial 16 weeks of therapy will then evaluate the toxicities, pharmacokinetics, and          preliminary efficacy of single drug therapy with indinavir.        3. Subsequently, all children who are able to tolerate the combination of zidovudine and          lamivudine (i.e., have no prior history of intolerance to one of these two agents) will          be treated with these two reverse transcriptase inhibitors in addition to the protease          inhibitor indinavir. Zidovudine and lamivudine will be added after 16 weeks at a fixed          dosage. Toxicity, pharmacokinetics, and preliminary efficacy of indinavir will also be          investigated after combination therapy. All patients who wish to remain in this study          after 96 weeks of therapy and who do not meet off study criteria will be permitted to          receive extended treatment with their current indinavir combination therapy for an          additional 48 weeks.      The study will determine the pharmacokinetic profile of indinavir, given as single drug or in     combination with zidovudine and lamivudine. It will assess the preliminary antiviral and     clinical activity by monitoring clinical status, viral burden in plasma, and markers of     immunologic status. Based on safety and preliminary efficacy results from studies performed     in adults, we will study three dose levels which are expected to result in drug levels above     the IC95 of HIV-1 for all or most of the dosing interval.   "
161847|NCT00001444|"     This is a dosage escalation study to estimate the maximum tolerated dose of staurosporine     analogue UCN-01. Groups of 3 to 6 patients receive a 72-hours intravenous continuous     infusions of UCN-01 from day 1 to day 4 of each cycle the first cycle only, and over 36-hours     on subsequent cycles. The side effects are allowed to disappear for up to 28 days. This cycle     is repeated after evaluations and follow-ups, which are every 4 weeks, as long as the patient     benefits.   "
161848|NCT00001445|"     This is a single dose, phase I study to evaluate the safety/tolerance and the immunogenicity     of HIV-1 Immunogen, gp120-depleted inactivated HIV-1 preparation in Incomplete Freund's     Adjuvant (IFA), in children with HIV-1 infection. A total of 32 children with HIV-1 infection     will be enrolled in the study. Arm A of the study will enroll children who have no or     moderate immune suppression at the time of study entry as defined by CDC classification and     who have no history of and do not require antiretroviral therapy. Antiretroviral treatment     given for less than 7 weeks (up to 6 weeks and 6 days) prior to entry will be considered as     no history of treatment (treatment naive). Arm B will enroll children who have no or     moderate immune suppression at the time of study entry as defined by CDC classification and     who are on or have received antiretroviral treatment for more than 7 weeks. In order to     assess the age-associated impact on the immune response rate, we plan to continue to attempt     to enroll infants younger than 24 months of age. Children in each arm will receive 10 units     of HIV-1 Immunogen intramuscularly at 0, 3, 6, 9, and 12 months.      Antiretroviral treatment will commence once patients meet the criteria for an initiation of     the treatment as defined in the protocol. All antiretroviral agents that are currently     approved by FDA for clinical indications in HIV-1-infected children (pediatric labeling) are     permitted in the protocol. If the child has been receiving a single agent other than ddI, or     has been on investigational antiretroviral agents, his/her antiretroviral therapy will have     to be changed to an optimal combination regimen of the approved agents at least 6 weeks prior     to the enrollment.   "
161849|NCT00001446|"     This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide     in patients with hormone-refractory prostate cancer.      An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as     well as make correlations between the degree of angiogenesis occurring in a patient and the     activity of thalidomide.   "
161850|NCT00001448|"     The main objectives of this study are: 1) to determine whether various levels of severity of     oral candidiasis (thrush) in the child are associated with different levels of speech     production, feeding skills, and self-concept, and 2) to assess the effect of the reduction of     oral thrush over time on the speech function, feeding skills, and self-concept in     HIV-infected patients who already are receiving various antifungal medications for treatment     of their thrush (Note: Decisions regarding antifungal therapy are made completely independent     from this study).      Children with HIV disease, ages 6-21 years, who have oral thrush are eligible to paricipate     in the study. The child and his/her parent will be asked to complete a variety of measures at     specific time intervals over approximately one month during visits to the National Institutes     of Health for treatment on other protocols. First, a nurse will rate the location and     severity of thrush in the child's mouth. Then the parent will complete questionnaires     assessing the effect of oral thrush on the child's feeding and speech skills and everyday     functioning. Finally, the child will be administered a brief speech and oral-motor evaluation     and will complete some questionnaires about how the thrush affects his/her day-to-day     activities and self-concept.      The results of this study may help to better understand the cause of expressive language     deficits observed in some children with HIV infection. More specifically, it will determine     if any speech and feeding problems of HIV-infected children are associated with oral thrush.     Learning more about the impact of oral thrush on the speech, feeding, and the self-concept of     children with HIV disease may be used for parent and patient education and to develop     rehabilitative recommendations to benefit HIV-infected patients with oral thrush.   "
161851|NCT00001449|"     The purpose of this study is to determine the clinical toxicities associated with     administering sequential dFdC as a one hour infusion followed by a continuous infusion of     FUdR over 24 hours with low dose oral LV weekly for three weeks out of four.   "
161852|NCT00001450|"     This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous     infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV     or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to     determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in     patients with advanced NSCLC.   "
161853|NCT00001451|"     Individuals interested in becoming prospective bone marrow donors and joining the Registry of     the National Marrow Donor Program (NMDP) should do so by calling 301-496-0572, the phone     number of the NIH Marrow Donor Center. An appointment will be made to have a health history     taken and to have a buccal swab collected for tissue (HLA) typing. The current protocol only     involves donors already registered with the NMDP, who have been identified as perfect     matches for an unrelated patient requiring a bone marrow transplant, and who require     expedited medical evaluation prior to marrow collection.   "
161854|NCT00001452|"     Lentiginosis refers to groups of diseases marked by the presence of pigmented spots on the     skin. These conditions are most commonly associated with multiple tumors and changes in     hormone producing glands. The cause of these diseases is unknown, but researchers suggest     there may be a level of inheritance involved in their development. Meaning to say that some     of these diseases may run in the family and be passed down form generation to generation.      Primary pigmented nodular adrenocortical disease (PPNAD) is a pituitary-independent, primary     adrenal form of hypercortisolism characterized by;        1. <TAB>Resistance to suppression by the drug dexamethasone        2. <TAB>The body is unable to secrete cortisol in a normal rhythm        3. <TAB>Distinct microscopic changes of both adrenal glands      PPNAD can be associated with tumors (myxomas) of the skin, heart, breast, tumors (swannomas)     of the nerve sheaths, pigmented spots (nevi and lentigines) of the skin, growth hormone (GH)     producing tumors of the pituitary gland, and tumors of the testicles, ovaries, and thyroid     gland. In the presence of these associations the condition is referred to as the Carney     Complex. Presently there are no tests for screening of PPNAD and the Carney Complex. In     addition, it is unknown how these conditions are genetically transferred from generation to     generation.      This study proposes to use standard methods of clinical testing for endocrine and     nonendocrine diseases and genetic testing in order to;        1. <TAB>Define the genetic basis for PPNAD and/or the Carney Complex.        2. <TAB>Determine the molecular changes associated with the development of the tumors.        3. <TAB>Identify carriers of the disease.        4. <TAB>Determine the prognosis for carriers and affected individuals.        5. <TAB>Provide sufficient data for genetic counseling of families with PPNAD and/or Carney          Complex.<TAB>   "
161860|NCT00001458|"     An important mission of the National Institutes of Health (NIH) is to develop and carry out     research studies designed to improve understanding of disease processes and treatments.      Clinical research continues to become more focused on specific diseases and the signs and     symptoms of diseases in specific groups of people and patients.      This study is designed to permit inpatient evaluation and care of patients with heart disease     who do not qualify to participate in research studies being conducted by the Cardiology     Branch of the National Heart, Lung, and Blood Institute (NHLBI). These patients are valuable     to the Cardiology Branch of the NHLBI because they help to improve training and experience of     its researchers.   "
161855|NCT00001453|"     Patients with Cushing disease have hormone producing tumors in their pituitary gland. Often     these tumors are so small they cannot be detected by magnetic resonance imaging (MRI). The     inferior petrosal sinuses are small veins that drain the blood from the pituitary gland. By     taking a small sample of blood from these sinuses, doctors can differentiate a small tumor in     the pituitary gland from other tumors in the body producing the hormone. Patients with     Cushing disease have high levels of the hormone ACTH in the petrosal sinuses. Patients with     other causes of Cushing syndrome do not have increased levels of ACTH in the petrosal     sinuses.      The procedure to collect blood from the petrosal sinus is called Inferior Petrosal Sinus     Sampling (IPSS). The technique is very sensitive and can tell the difference between a     pituitary tumor and other causes of Cushing syndrome nearly 100% of the time. However, IPSS     is very difficult to perform and is only available in a few hospitals. Therefore, researchers     are looking for another possible way to diagnose Cushing syndrome that would be less     technically difficult and more readily available to patients.      ACTH is produced in the pituitary gland as a response to the production of     Corticotropin-Releasing Hormone (CRH) in the brain (hypothalamus). This study will compare     ACTH levels in the internal jugular veins before and after CRH stimulation with those     obtained by conventional IPSS from patients with Cushing's syndrome.      Obtaining blood from the jugular veins is a simple, practically risk free procedure that     could be done easily in a community hospital on an out patient basis. Researchers believe     that CRH stimulation will increase ACTH production from tumors of the pituitary gland     (corticotroph adenomas) so that the diagnostic information from jugular venous sampling would     be equivalent to that of IPSS.      This proposal to develop jugular venous sampling (JVS) with CRH stimulation as a test for the     differential diagnosis of Cushing Syndrome would potentially contribute greatly to the     medical care of patients with Cushing syndrome, as a less costly, safer and more widely     available alternative to IPSS.<TAB>   "
161856|NCT00001454|"     Endometrium is the lining of the uterus. It is where the fertilized egg normally implants     during pregnancy.      This study was designed to better understand the way(s) that female sex hormones (estrogen     and progesterone) cause the uterus to grow and develop. It is known that these hormones are     necessary to prepare the uterus for pregnancy, but the way the hormones work is unknown.      Researchers would like to identify the genes that are affected by female sex hormones by     using a variety of tests (in situ hybridization, immunohistochemistry, and culture of human     endometrium).      Researchers will select women who have regular monthly menstrual cycles and study them for     two cycles;        1. <TAB>The first cycle (PRE-BIOPSY CYCLE) will include daily measurements of the patient's          body temperature and progesterone measurements during the last 14 days (luteal phase) of          the menstrual cycle.        2. <TAB> The second cycle (BIOPSY CYCLE) will include measurements of urinary luteinizing          hormone (LH) to determine the day of the LH surge. Luteinizing hormone is the hormone          that causes the ovary to release the developed egg. Ovarian ultrasounds will be          performed before the biopsy to determine development of the egg. Blood tests will be          taken on the day of the biopsy to have an overall idea of the hormones circulating in          the patient's blood. An endometrial biopsy will be taken at one of three possible times          to identify endometrial products under conditions of estrogen, estrogen/progesterone, or          steroid hormone withdrawal.<TAB>   "
161857|NCT00001455|"     Iron overload (hemochromatosis) is a condition which causes the intestines to take too much     iron into the body from food or pills. The extra iron can build up in the liver, heart,     joints, pancreas, sex organs, and other organs. Patients with iron overload can feel well     initially, but the iron will eventually damage organs and may lead to an early death. The     condition is believed to be passed down from generation to generation. Many studies have been     conducted on the condition as it affects Caucasian Americans, few have addressed the     condition in African Americans.      Researchers believe it is important to find out as much as possible about the iron overload     in African Americans. The goal of this study is to determine the pattern of inheritance of     primary iron overload in African American families and to identify the genetic defect causing     the condition.      The study will use various tests from simple blood testing (transferritin saturation and     serum ferritin levels) to complex genetic tests (segregation analysis and polymerase chain     reaction [PCR]). The tests will help researchers deterimine iron levels in the blood,     presence of antigens that may help trace inheritance, and detect changes in genes that are     known to cause iron overload in Caucasians.      The study may not directly benefit the patients participating in it. However, this study may     lead to improved methods to diagnose iron overload in the African American population as a     whole.   "
161858|NCT00001456|"     Hermansky-Pudlak Syndrome (HPS) is an inherited disease which results in decreased     pigmentation (oculocutaneous albinism), bleeding problems due to a platelet abnormality     (platelet storage pool defect), and storage of an abnormal fat-protein compound (lysosomal     accumulation of ceroid lipofuscin).      The disease can cause poor functioning of the lungs, intestine, kidneys, or heart. The major     complication of the disease is pulmonary fibrosis and typically causes death in patients ages     40 - 50 years old. The disorder is common in Puerto Rico, where many of the clinical research     studies on the disease have been conducted. Neither the full extent of the disease nor the     basic cause of the disease is known. There is no known treatment for HPS.      The purpose of this study is to perform research into the medical complications of HPS and     begin to understand what causes these complications. Researchers will clinically evaluate     patients with HPS of all ethnic backgrounds. They will obtain cells, blood components     (plasma), and urine for future studies. Genetic tests (mutation analysis) to detect     HPS-causing genes will also be conducted.<TAB>   "
161866|NCT00001465|"     Pulmonary lymphangioleiomyomatosis (LAM) is a destructive lung disease typically affecting     women of childbearing age. Currently, there is no effective therapy for the disease and the     prognosis is poor.      This study is designed to determine the disease processes involved at the level of cells and     molecules, in order to develop more effective therapy.      Researchers intend to identify the proteins and genes that contribute to the process of lung     destruction in affected individuals.   "
162290|NCT00002160|"     To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer     and AIDS patients.   "
161859|NCT00001457|"     Chronic hepatitis B is a disease of the liver caused by the hepatitis B virus. It affects     nearly 1 million Americans. Approximately 25% of patients with chronic hepatitis B will     develop liver cirrhosis and 5% of patients will develop liver cancer.      Presently, two medications have been shown effective in the treatment of hepatitis B:     lamivudine and alpha interferon. Alpha interferon (an antiviral drug that acts through the     immune system) is given by injection once daily or three times a week for four to six months.     Lamivudine (also known as 3-thiacytidine: 3TC) is an antiviral medication given as a pill     once a day for twelve months. These treatments have been known to provide long-term     improvement in one third of patients receiving them.      In previous research, the drug lamivudine was shown to stop the growth of the hepatitis B     virus and to lead marked decreases in the levels of hepatitis B virus and to improvements in     the disease in 50 to 70% of patients. However, once lamivudine therapy was discontinued the     virus returned to levels noted before the therapy began. In those studies lamivudine was     given for 3 to 12 months then discontinued. This study will investigate the safety and     effectiveness of long-term therapy with lamivudine.      This study will select 60 patients diagnosed with hepatitis B. After a thorough medical     examination and liver biopsy, subjects will be given lamivudine. The drug will be taken by     mouth in tablet form (100 mg) once a day for up to 5 years. Subjects will undergo regular     check-ups and after 1 year of therapy be admitted to the Clinical Center for another medical     examination and liver biopsy to assess progress. Patients who have benefitted from the     therapy will continue taking the medication for up to 5 years. A third liver biopsy will be     done during the last year of treatment. The effectiveness of lamivudine will be determined by     whether levels of hepatitis B virus decrease in the blood, whether liver enzymes improve, and     whether inflammation and scarring decreases in the liver biopsies.   "
161861|NCT00001459|"     Myocardial ischemia is a heart condition in which not enough blood supply and oxygen reaches     the heart muscle. Damage to the major blood vessels of the heart (coronary artery disease),     minor blood vessels of the heart (microvascular heart disease), or damage to the heart muscle     (hypertrophic cardiomyopathy) can cause myocardial ischemia. Any of theses three conditions     can cause patients to experience chest pain and other symptoms as well as cause the heart to     function improperly.      In order to detect myocardial ischemia researchers can use tests to measure the movement of     the walls of the heart. Walls receiving inadequate supplies of blood often move less and     occasionally move in the opposite direction. Some of the tests may require patients to     receive injections of radioactive tracers. The radioactive material acts to enhance 3     dimensional pictures of the heart and helps to identify areas of ischemia.      The purpose of this study is to determine whether 3-dimensional imaging (tomography) with     radioactive tracers can provide more important information about heart wall function than     routine diagnostic tests.   "
161862|NCT00001460|"     There is an important need to maintain clinical skills, provide quality training and     expertise, and provide an environment that stimulates ideas for clinical research.      This study permits inpatient evaluation and management of patients with heart disease who do     not qualify to participate in studies currently being conducted by the Cardiology Branch of     the National Heart, Lung, and Blood Institute.   "
161863|NCT00001461|"     The walls of blood vessels are lined by flat cells that are responsible for releasing     substance(s) that control the activity of the blood vessel. These cells are referred to as     the endothelium of the blood vessel. One of the substances released from the endothelium is     called nitric oxide (NO). This substance functions to keep blood vessels relaxed and to     prevent blood from clotting inside the vessels.      Studies done by researchers in the Cardiology Branch of the National Heart, Lung and Blood     Institute have shown that nitric oxide activity may be lower in patients with hardening of     the arteries (atherosclerosis) and risk factors for atherosclerosis.      Another substance released by the cells of the endothelium is called bradykinin. It functions     to stimulate the production of nitric oxide. Therefore bradykinin is also responsible for the     relaxation and widening of blood vessels.      An enzyme found in the blood called angiotensin-converting enzyme (ACE) inactivates     baradykinin and thereby decreases the production of nitric oxide. The activity of ACE is     determined by genetics and is different in each person. Medications that block ACE     (ACE-inhibitors) may be useful for patients with high levels of ACE activity.      This study is designed to determine;        1. The role of bradkinin in stimulating the production of nitric oxide        2. Whether ACE-inhibitors improve blood vessel relaxation caused by bradykinin        3. Whether ACE-inhibitors improve abnormal blood vessel relaxation        4. Whether ACE-inhibitors and bradykinin affect blood clotting        5. Whether blood vessel response to ACE-inhibitor and bradykinin depends on the patients          genetic make-up   "
161864|NCT00001462|"     Alpha 1-antitrypsin-deficient individuals develop severe destructive lung disease much     earlier and their lung function declines faster than the general population of individuals     with chronic obstructive lung disease. This study is designed to better understand the     pathogenesis of lung destruction in alpha 1-antitrypsin deficient individuals and to     characterize the pathobiology of early lung destruction. To accomplish this we intend to use     bronchoalveolar lavage to determine and quantify the factors that initiate and sustain lung     inflammation in alpha 1-antitrypsin deficient individuals with lung function above a force     expiratory volume in one second (FEV1) of greater than 50% of predicted.   "
161865|NCT00001464|"     Patients with lung disease experiencing difficulty breathing can be treated with oxygen     therapy. This involves the delivery of extra oxygen by a face-mask or through small tubes     placed in the nose called nasal prongs. This extra oxygen can have concentrations as high as     100% pure oxygen. The concentration of oxygen in normal air is only 21%. The high     concentration of oxygen can help to provide enough oxygen for all of the organs in the body.     Unfortunately, breathing 100% oxygen for long periods of time can cause changes in the lungs,     which are potentially harmful. Researchers believe that by lowering the concentration of     oxygen therapy to 40% patients can receive it for longer periods of time without the risk of     side effects.      This study is designed to evaluate the effects of oxygen therapy at 100% and 40% for 12 18     hours on the lungs of normal volunteers. Results of this study will help to determine if     levels of oxygen therapy currently accepted as being safe may actually be damaging to the     lungs.   "
162291|NCT00002161|"     To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA     ) in combination with standard antiretroviral therapy for 48 weeks.   "
162292|NCT00002162|"     To evaluate the antiviral activity and safety of two formulations of saquinavir in     combination with licensed nucleoside antiretroviral drugs.   "
161867|NCT00001466|"     This study will investigate the cause and natural history (medical problems that appear over     time) of certain genetic disorders. It will also try to locate the abnormal genes responsible     for these conditions and eventually develop tests to predict who is likely to be affected and     to what degree.      Patients with known or suspected genetic disorders in certain categories, such as those     involving chromosomal or metabolic abnormalities, immune system or blood disorders, abnormal     growth, benign tumors, and others may be eligible for this study. Participants will be     interviewed by specialists in genetics about their condition and family history. They may     also be asked to have a physical examination and certain tests needed for study of the     specific individual's condition. These may include collection of blood samples (up to 3     tablespoons); imaging studies, such as computerized tomography (CT), magnetic resonance     imaging (MRI), ultrasound and echocardiography; skin biopsy (removal of a small sample of     skin tissue under local anesthetic), and other procedures. DNA testing may reveal the genetic     abnormality responsible for the disorder. Participants who so wish will have an opportunity     to talk with experts about the health implications of the test results.      This study may provide information that will lead to improved treatment or management of     these inherited disorders, as well as more effective genetic counseling for families.   "
162007|NCT00000998|"     To evaluate the safety and effectiveness of trimetrexate (TMTX) given at increasing doses     along with the leucovorin calcium (LCV) for treating Pneumocystis carinii pneumonia (PCP) in     AIDS patients TMTX is an experimental new drug which is effective for treatment of PCP, but     has been given to only a few patients. Therefore it is not certain if TMTX is better, the     same as, or not as effective as conventional drugs against PCP.   "
161868|NCT00001467|"     The purposes of this study are to 1) identify the genes responsible for certain immune     disorders, 2) learn about the medical problems they cause, and 3) learn how to predict who is     likely to develop these disorders and what the risk is of passing them on to children. The     immune system is the body s defense system. Some immune deficiencies impair a person s     ability to fight infections; others render a person susceptible to allergies, or to     autoimmune diseases such as lupus or arthritis, in which the immune cells (white blood cells)     attack and destroy the body s own tissues.      Patients with immune disorders known or suspected to have a genetic basis and their family     members may enroll in this study. Eligibility will be determined by a review of the patient s     medical records and family medical history. Participants will provide a small blood sample     for genetic (DNA) and white blood cell analysis. Gene samples (but not white blood cells) may     also be obtained by mouth brushing or skin biopsy. For the mouth brushing, a small brush is     rubbed against the inside of the cheeks for 1 minute to wipe off some cells. For the skin     biopsy, a small circle of skin (about 1/8 inch) is removed under local anesthetic. Pregnant     women may be asked to provide a fetal sample (amniotic fluid cells or chorionic villus     sample). All samples will be used for immune or genetic studies of the family s immune     disorder.      If test results show a specific genetic variation responsible for the family s immune     disorder, a report will be sent to the patient s doctor or genetic counselor, who will     discuss the implications for the family. NIH researchers and genetic counselors will also be     available to explain results and answer questions. Information will not be available in the     case of disorders that cannot yet be linked to a specific genetic abnormality.      Information from this study will increase knowledge about the immune system and what causes     immune deficiencies. Participants may also learn the underlying cause of an immune disorder     that affects them or someone in their family information may be useful in guiding treatment     and in making decisions regarding family planning.   "
161869|NCT00001468|"     This study will identify how personal beliefs, values and family experiences affect a     person's decision as to whether or not to be tested for changes in a gene called BRCA1 or     BRCA2. Changes in these genes are associated with a significantly increased risk of breast     and ovarian cancer in women, a slightly higher risk of prostate cancer in men, and a slightly     higher risk of colon cancer in both men and women.      Families enrolled in the National Cancer Institute's familial cancer research project who     also participated in a telephone survey (protocol 78-C-0039) regarding their level of     interest in BRCA1/2 testing results may be eligible for this study.      All participants will complete a 20- to 30-minute questionnaire assessing knowledge, risk     perception and personality traits, and will participate in an education session to review the     following:        -  Information about their individual cancer risk, based on family history        -  Potential benefits and risks (medical, psychological and social) of BRCA1/2 testing,          both for those who test positive and those who test negative        -  Overview of DNA testing (what is done and how accurate it may or may not be)        -  Medical management options for those at increased risk for breast and ovarian cancer        -  Environmental cancer risk factors        -  Instruction in breast self-examination      Participants will then be asked whether or not they want to undergo BRCA1/2 testing      Those who want to be tested will be divided into two groups to compare counseling methods     (client-centered vs. counselor-driven counseling). A small blood sample (2 to 3 tablespoons)     will be drawn for genetic analysis. Test results will be provided in person at a second     visit-this may take 6 months or more. A follow-up telephone call 2 weeks after receipt of the     test results will address participants' questions and provide support. During a third visit,     scheduled 6 months after receipt of the test results, participants will complete     questionnaires evaluating mood, attitude, self-esteem, family interactions, cancer screening     practices, and other factors. Finally, 1 year after receipt of the test results, participants     will be contacted by telephone and asked about their feelings about the test and its outcome.      Individuals who choose not to have gene testing will not participate in any in-person     sessions after the initial visit. They will be followed with no more than two telephone     interviews to assess their feelings and attitudes related to their decision not to be tested.      Individuals may reconsider and change their mind at any time regarding their decision-whether     to be tested or not.      The results of the study will help experts devise the most effective methods of educating and     counseling people at high risk for having an altered BRCA1/2 gene.   "
161870|NCT00001469|"     Molecular approaches to the understanding of human neoplastic disease have revealed that     multiple genetic alterations are an essential component of tumorigenesis. Both germline and     somatic genetic alterations can be involved in the malignant transformation of normal cells.     Identification of the genes involved in neoplastic transformation has been approached through     the molecular analysis of sporadic cancers and the genetic study of families with an     inherited predisposition for cancer. The interplay of these two approaches has led to the     characterization of genes such as the retinoblastoma (Rb) gene, the p53 gene and the     adenomatous polyposis coli (APC) gene that are all involved in the development of both     hereditary and non-hereditary forms of cancer. Inherited mutations in such genes predispose     affected families to hereditary cancer syndromes, affording an opportunity to identify     genetic lesions that also cause the more common sporadic cancers.      Prostate cancer (PRCA) is the most common cancer diagnosed (1999 estimate 179,300 cases) and     the second leading cause of cancer mortality (1999 estimate 37,000 deaths) in men in the     United States. Family history is the single strongest risk factor currently known for     prostate cancer. This raises the possibility that heritable genetic factors may be involved     in the development of this disease in a subset of men. The genetic contribution to diseases     of complex origin such as cancer is often most salient in families of early onset cases.     Therefore, prostate cancer inheritance following a simple Mendelian pattern may be identified     in the families of probands with early-onset cases. Common susceptibility alleles of small     effect may be detectable in families with later-onsent and/or less strong family history of     PRCA or in case-control data.   "
161897|NCT00001504|"     This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic     acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral     9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the     regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the     study if medically appropriate.   "
162056|NCT00001047|"     To compare the safety and efficacy of two doses of clarithromycin in combination with     ethambutol and either rifabutin or clofazimine for the treatment of disseminated     Mycobacterium avium Complex (MAC) disease in AIDS patients.      Recommendations have been issued for AIDS patients with disseminated MAC to be treated with     at least two antimycobacterial agents and for every regimen to include a macrolide     (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains     unknown.   "
161871|NCT00001471|"     This study will examine tissue from the tonsils, lymph nodes and large bowel of HIV-infected     patients to investigate changes in viral load and certain white blood cells during treatment.      Normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this     study. Candidates will be screened with a medical history, physical examination, blood and     urine tests and possibly an electrocardiogram (EKG). Blood tests may include HLA typing, a     genetic test of immune system markers.      Participants may undergo the following procedures:        -  Blood tests (patients and volunteers)        -  Biopsies The frequency of biopsies for given patients may vary, depending on their          specific therapy. Typically, biopsies are done at a single time, or for patients          starting a new therapy, biopsies could be performed before starting therapy, during          therapy and possibly after completion of therapy.        -  Tonsil biopsies (patients and volunteers) Volunteers will have one tonsil biopsy.          Patients will have no more than six tonsil biopsies, with no more than three in a 10-day          period. The biopsy is done by an ear, nose and throat specialist as an outpatient          procedure. The tonsils are numbed with a local anesthetic, and one to four pieces of          tissue are extracted.        -  Lymph node biopsies (patients only) Patients will have no more than four lymph node          biopsies, performed no more frequently than once a month. The biopsy is done by a          surgeon and may require a 2- to 3-day hospital stay. The skin above the lymph nodes is          numbed with a local anesthetic, an incision is made and the tissue is removed.          Alternatively, a needle biopsy may be done, in which a small amount of lymph tissue is          withdrawn through a special needle injected into the site.        -  Intestinal biopsies (patients and volunteers) Volunteers will have one intestinal biopsy          procedure. Patients may have up to six intestinal biopsy procedures, each separated by          at least 10 days. This is done by a gastroenterologist as an outpatient procedure. A          flexible tube (sigmoidoscope or colonoscope) with a light and special lens at the tip is          inserted into the rectum and large bowel. Wire instruments passed through the tube are          used to extract small tissue samples.        -  Bronchoalveolar lavage (BAL; patients and volunteers) Volunteers and patients will          undergo bronchoscopy in which a flexible tube (bronchoscope) with a light and special          lens at the tip is inserted through the nose or mouth into the lungs, and the lining of          the lung is sampled by washing the airways with small amounts of saline. The procedure          is performed by a pulmonologist or critical care specialist, usually as an outpatient.   "
161872|NCT00001473|"     This study will evaluate the safety and effectiveness of a staged approach to therapy for     Wegener's granulomatosis and other systemic vasculitides using prednisone plus     cyclophosphamide followed by methotrexate. Vasculitides involve inflammation of blood vessels     (vasculitis) that may affect the brain, nerves, eyes, sinuses, lungs, kidneys, intestinal     tract, skin, joints, heart and other sites. Standard treatment with prednisone and     cyclophosphamide is very effective, but has significant toxicity (adverse side effects).     Methotrexate is also an effective treatment and is less toxic, but it is associated with a     higher rate of disease recurrence and has not been used in patients with severe lung or     kidney disease. Staged therapy using cyclophosphamide first and then methotrexate may provide     better results for overall safety and effectiveness.      Patients 10 to 80 years of age with active Wegener's granulomatosis, polyarteritis nodosa or     a related systemic vasculitis may be eligible for this study. Candidates will be screened     with a medical history and physical examination, blood and urine tests, chest X-ray,     electrocardiogram (EKG) and pulmonary function tests. Other procedures, such as biopsies,     will be done only as medically indicated.      Participants will be treated initially with 1 milligram/kilogram body weight of prednisone     once a day and 2 to 4 mg/kg cyclophosphamide once a day. If the disease improves     significantly, prednisone will be gradually reduced and stopped, and if remission is     achieved, cyclophosphamide will be stopped. Methotrexate will then be started at 0.3 mg/kg     body weight once a week and then increased to 0.5 mg/kg after 2 to 4 weeks. Methotrexate     therapy will continue for at least 2 years. If at the end of 2 years the disease remains in     remission, the methotrexate will be gradually reduced and stopped. If, on the other hand,     active disease recurs during methotrexate treatment, the therapy will be changed. The new     choice of treatment will depend on the severity of recurrence, pre-existing medical     conditions, and previous adverse reactions to prednisone, cyclophosphamide and methotrexate.      Patients will be seen periodically for a physical examination and blood tests to evaluate     disease activity, response to therapy and drug side effects. X-rays will be done as medically     indicated. Evaluations will be scheduled once a month until the patient has been on     methotrexate for 3 months and then every 3 months for the next 18 months. Patients whose     disease remains in remission at that time and are off all medications will be seen every 6     months for another 4 visits.   "
161873|NCT00001474|"     This study is designed as a randomized, open trial of intermittent continuous infusions of     Interleukin-2 in HIV seropositive patients with a CD4 cell count between 200 and 500     cells/mm(3). The goal of the study is to determine the optimal duration of each infusion, and     the optimal interval between infusions. Thirty-six patients will be randomized to 3 groups:     Group A will be the control group with a regimen of five day infusions of IL-2 every eight     weeks; Group B will receive IL-2 infusions every eight weeks, however the duration of each     infusion will be determined by parameters reflecting T cell proliferation, with     discontinuation of each infusion at a point when the response appears to be maximized; Group     C will receive five day infusions of IL-2; however the interval between infusions will be     determined by the response seen to the prior infusion, with the goal of administering     infusions while the CD4 cell count remains above baseline from the prior infusion. The dose     of interleukin-2 to be used will be 9 MIU by continuous infusion daily. All patients will be     evaluated at the NIH at least every 4 weeks, and at that time safety labs and immune studies     will be performed. In addition, patients in Groups B and C will undergo a laboratory     evaluation weekly, at which time immune parameters, including CD4 number and percent,     spontaneous blast transformation, soluble IL-2 receptor levels, and viral parameters,     including branched DNA assay and p24 antigen, will be determined. The study duration will be     approximately one year.   "
161874|NCT00001475|"     Patients enrolled in NIH protocol 95-I-0133 at the Clinical Center may participate in an     extension phase of this study in which the drug prednisone will be eliminated from the     treatment regimen. Prednisone is associated with avascular necrosis, a condition that has     been found in a number of patients in this study. Also, certain patients in this protocol may     receive future interleukin-2 treatment cycles at home. Home administration of IL-2 injections     involves less frequent data and safety monitoring and no medical evaluations at the Clinical     Center except at the beginning of each cycle.      To be eligible for home administration of IL-2, patients must:        -  Be enrolled in a current NIAID protocol for IL-2 therapy and have received at least 1          year of treatment on the protocol, with at least two well-tolerated outpatient cycles at          a stable dose.        -  Have a history of tolerable side effects while receiving IL-2 without frequent medical          interventions, intravenous fluid replacement or dose reductions.        -  Not have had any significant clinical or laboratory abnormalities during days 0 to 5 of          the last two outpatient cycles.        -  Have a strong relationship with a private physician or health-care provider who has been          involved in the patient's care and is willing to help supervise the patient's care          during each home IL-2 cycle.        -  Live in a home with easy telephone access and have proved reliable in responding to          telephone calls from clinic staff.        -  Give the clinic staff contact information for a close friend or relative who will agree          to serve as a caregiver during each home cycle, providing the patient non-medical          assistance and checking on his or her condition daily.        -  Have reasonable access to emergency medical services and a nearby medical facility.        -  Have proved reliable and consistent in using sterile technique, reconstituting IL-2          vials and administering subcutaneous IL-2 injections.        -  Be receiving outpatient IL-2 injections cycles at least once every 6 months as part of          their normal protocol participation.        -  Have access to a home weight scale and be able to weigh themselves each day for safety          monitoring.      Participants will receive IL-2 cycles on the same schedule they followed in their original     protocol participation. They will be seen at the Clinical Center at regularly scheduled     follow-up visits between cycles and for a medical evaluation and blood drawing before the     start of each cycle to determine the safety of administering the cycle. During the home     cycle, the patient's case manager or other team member will place monitoring telephone calls     on days 2 and 4 of the cycle and again a week later. The timing and number of these calls may     change depending on the findings of ongoing assessments of their usefulness. Patients will be     required to notify the study team promptly of any complications or other problems that     develop with therapy.   "
161995|NCT00000986|"     To test the safety and tolerance of three different doses of recombinant human interleukin 2     (aldesleukin; IL-2), when it is given for five consecutive days to patients with AIDS or AIDS     related complex (ARC), who have also received zidovudine (AZT) for at least 6 weeks just     before beginning the IL-2 treatment.      AZT is an antiviral drug, which has been shown to be beneficial in some patients with AIDS.     IL-2 is a substance found naturally in the body that boosts the body's immune response to     invading organisms and tumor cells. These two drugs, when administered together, may have a     mutually helpful effect in treating AIDS patients, but before this effect can be studied, it     is important to understand the proper dose and any side effects that may occur when these     drugs are used together. The study will show how much AZT and IL-2 patients can safely take     at the same time and how the two drugs will interact with each other.   "
161875|NCT00001476|"     This protocol will follow patients who participated in NIAID's study Gene Therapy Approach     for Chronic Granulomatous Diseases (95-I-0134). No further gene therapy treatments will be     given under this protocol. However, because gene therapy is a new technology and involves a     permanent change in the genetic code of some cells, patients who have had this treatment     require long-term health monitoring.      Participants will be asked to provide updated address and telephone information and the names     of two contact persons, such as siblings or friends. Patients will be seen about once a year     at the NIH Clinical Center to provide an update on their health status and donate a small     blood sample (about 2 teaspoons), which will be frozen and stored. If a patient acquires a     serious illness, such as cancer, his or her stored blood will be tested; another of blood or     tissue sample may also be requested for further study. If a patient develops a medical     problem that is thought possibly to be related to gene therapy, the illness will be     investigated. The annual follow-up visits will continue indefinitely or until the patient     declines to continue participation.      Participants may also agree to store some of their blood future research on chronic     granulomatous diseases and other medical conditions. Stored samples may be labeled with a     code, such as a number, that only the study team can link with the patient. Any identifying     information about the patient will be kept confidential as is permitted by law.   "
161876|NCT00001477|"     Patients are exposed to infectious agents regularly, regardless of their immunologic status.     Traditionally clinicians have decided to institute prophylaxis based on epidemiologic     factors, skin test (i.e. PPD), or immunologic parameters. A quantitative and specific method     that is non-invasive, such as quantitative PCR, would be desirable to more precisely define     those who would benefit from prophylaxis. Similarly, when patients develop disease and are     being treated, quantitative, non-invasive techniques are needed to assess response to     therapy. This project is designed to develop and test quantitative tests using blood, urine,     or sputum samples.   "
161877|NCT00001478|"     Positron Emission Tomography (PET) is a technique used to investigate the functional activity     of the brain. The PET technique allows doctors to study the normal biochemical and metabolic     processes of the central nervous system of normal individuals and patients with neurologic     illnesses without physical / structural damage to the brain.      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and     water. Blood carries fuel to the brain and waste products away from the brain. As brain     activity increases blood flow to and from the area of activity increases also. Knowing these     facts, researchers can use radioactive chemicals (H215O) and PET scans to observe what areas     of the brain are receiving more blood flow.      Patients diagnosed with mood disorders and healthy volunteers will receive positron emission     tomographic (PET) scans with H215O while doing simple tasks. Patients will continue to     receive scans while in different mood states and while taking different medications. Patients     eligible for this study will be participating in other research studies measuring other     clinical and biochemical parameters (mood and anxiety ratings, medication responses, and     psychological test results). Information gathered from H215O PET scans measuring blood flow     to specific brain areas will be compared to the data gathered from other studies.      Objectives of this study are;        1. To determine differences in blood flow to the brain of patients with mood disorders          compared to healthy volunteers.        2. To determine differences in blood flow to the brain of patients with subtype mood          disorders (such as unipolar versus bipolar) compared to healthy volunteers.      2. To determine changes in blood flow to the brain of patients with mood disorders who     experience spontaneous changes in symptoms      3. To determine changes in blood flow to the brain of patients with mood disorders who     receive various kinds of therapy (medication, transcranial magnetic stimulation, etc.)      4. To determine if blood flow to specific areas of the brain can be used to predict how     patients will respond to certain types of therapy      5. To compare blood flow changes with various other clinical and biochemical parameters.   "
161878|NCT00001479|"     Major depression represents a major public health problem worldwide and in the U.S. Fifteen     percent of the U.S. population has depression at some point in life (40 million individuals).     The condition is more common in women, occurring at a female to male ratio of 5:2. Presently,     6-8% of all outpatients in primary care meet the diagnostic criteria for major depression.     Fifteen percent of untreated patients with depression will commit suicide. Most of the people     committing suicide are depressed. Researchers believe that by the year 2020 suicide will be     the 10th most common cause of death in the U.S.      In addition to mortality due to suicide, depression is also associated with other severe     health conditions. Areas of the brain (hippocampus) begin to deteriorate, heart disease, and     decreased bone mineral density (osteoporosis) are all associated with major depression.      Researchers have believed for years that hormones controlled by the hypothalmus, pituitary     gland, and adrenal gland (commonly referred to as the HPA axis or system) are in some way     associated with psychiatric illnesses like depression.      According to previous studies, researchers have theorized that increased activity of the HPA     axis is associated with depressed patients with typical melancholic features. Melancholia     refers to the feelings of anhedonia (absence of pleasure from activites that would normally     be thought of as pleasurable), insomnia (inability to sleep), guilt, and psychomotor changes.     On the other hand a decrease in activity of the HPA axis may be associated with the atypical     features of depression.      This study has already developed and refined studies that have improved the understanding of     the HPA axis in healthy humans and depressed patients. Researchers have already identified     and plan to continue identifying distinct subtypes of depressive disorders based on the     activity of the HPA axis.   "
161879|NCT00001480|"     The purpose of this study is to evaluate people with mild memory problems, those with     dementia, those at risk for developing Alzheimer's disease (AD), and healthy volunteers to     identify markers of AD before the changes that occur with the disease begin.      The origin and markers of progression for Alzheimer's disease (AD) are relatively obscure.     Despite increased understanding of the underlying biology of AD, its clinical diagnosis is     still made only after progressive cognitive decline; definitive diagnosis is confirmed at     autopsy. This study will examine biomarker changes over time in a distinct cohort of people     with an increased risk of developing AD. The study will also identify and track biological     changes that occur with progressive dementia and compare those changes to the known cognitive     and emotional disturbances that characterize AD.      Individuals with a first-degree relative with AD will be recruited into an at-risk cohort.     They will be followed and compared to a group of healthy volunteers for a minimum of 8 years.   "
161880|NCT00001481|"     Determine whether postpartum depression is triggered by the abrupt withdrawal of estrogen and     progesterone.      The appearance of mood and behavioral symptoms during pregnancy and the postpartum period has     been extensively reported. While there has been much speculation about possible biologically     based etiologies for postpartum disorders (PPD), none has ever been confirmed. Preliminary     results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women     with menstrual cycle related mood disorder, but not controls, experience mood disturbances     during exogenous replacement of physiologic levels of gonadal steroids. The present protocol     is designed to create a scaled-down hormonal milieu of pregnancy and the puerperium in     order to determine whether women who have had a previous episode of postpartum major     effective episode will experience differential mood and behavioral effects compared with     controls and to determine whether it is the abrupt withdrawal of gonadal steroids or the     prolonged exposure to gonadal steroids that is associated with mood symptoms.     Supraphysiologic plasma levels of gonadal steroids will be established, maintained, and then     rapidly reduced, simulating the hormonal events that occur during pregnancy and parturition.     This will be accomplished by administering estradiol and progesterone to women who are     pretreated with a gonadotropin releasing hormone (GnRH) agonist (Lupron). After eight weeks,     administration of gonadal steroids will be stopped in one group of patients and controls, and     a sudden decline in the plasma hormone levels will be precipitated. Another group will be     maintained on supraphysiologic levels of estrogen and progesterone for an additional month.     Outcome measures will include mood, behavioral and hormonal parameters as well as response to     o-CRH (a separate protocol done in collaboration with NICHD).   "
162293|NCT00002163|"     To evaluate the benefit of adding 1592U89 to current antiretroviral therapies for AIDS     dementia complex and to assess the safety and tolerance of the treatment regimens.   "
161881|NCT00001482|"     This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal)     Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective     disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that     of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so     that we examine possible clinical and biological factors predictors of response. The drugs     will be given in a randomized order for six weeks each and you will not know when you are on     a given one. There will be a 2-4 week washout period between treatments. If you respond     well to one of these treatments, a longer open continuation period will be offered at the end     of this study. This would involve one or both drugs in combination. A variety of rating     scales and brain imaging procedures will also be offered before and during each drug     evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious     potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine,     however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred     vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually     mild, and resolve with continued time on the drug or a decrease in dosage.   "
162251|NCT00002121|"     To perform preliminary clinical testing of diethylhomospermine (DEHSPM), a polyamine     analogue, for refractory AIDS-related diarrhea.      Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory     AIDS-related diarrhea.   "
161882|NCT00001483|"     This study will compare the effectiveness of relatively new antidepressants which have     different mechanisms of action.      Buproprion (Wellbutrin) works on dopamine and the dopaminergic pathway.      Sertraline (Zoloft) works as a selective serotonin reuptake inhibitor (SSRI).      Venlafaxine (Effexor) works as a mixed serotonin, norepinephrine, and dopamine reuptake     inhibitor.      Subjects enrolled in this study will be patients diagnosed with a bipolar disorder who are     presently taking medication to prevent the symptoms of the disease (prophylactic treatment),     but have had breakthrough episodes of depression despite taking their medication.      Patients will receive any one of the three antidepressant medications as noted above plus a     placebo inactive sugar pill, in order to mask which antidepressant is being prescribed) in     addition to their regular medication for bipolar disorder. All of the doses will be     calculated as effective for the treatment of a unipolar major depressive disorder. The     patient will continue receiving the medication for ten weeks.      The effectiveness of the drug treatment will be measured by using three different scales;        1. Inventory for Depressive Symptoms - Clinicians form (IDS-C)        2. Clinical Global Impression scale(CGI-BP)        3. Life Charting Methodology (LCM)      Patients who do not respond to their medication within ten weeks from the beginning of the     study will be considered as non-responders and be offered the opportunity to start the study     again, taking one of the two remaining medications. For example, if a patient was assigned to     take Wellbutrin but it was ineffective, he/she could re-enter the study and be given either     Zoloft or Effexor.      Patients that do respond in the first ten weeks of the study will be eligible to continue     taking the medication for one year to assess the long term effectiveness of the drug on     preventing episodes of depression and to assess for any possible differential induction of     mania.   "
161883|NCT00001485|"     As the seasons change during the course of the year, many animals show major changes in their     behavior and physiology. Many of these changes are triggered by changes in the length of time     each night that the pineal gland produces the hormone melatonin. Melatonin is produced for a     longer time in winter when nights are long, than in summer when nights are short.      Some researchers believe that melatonin may play a similar role in how season effects mood of     patients with seasonal affective disorder. Seasonal affective disorder (SAD) or mood disorder     with seasonal pattern is a condition where the normal biorhythm is disturbed during a season,     especially autumn-winter. Patients may begin experiencing or experience worsening of     depressive symptoms. Patients complain of being constantly tired, craving sugary foods,     overeating, and over sleeping.      Researchers have collected some preliminary data showing that the duration of nighttime     melatonin secretion increases in winter and decreases in summer in healthy women, but not in     healthy men. However, men diagnosed with SAD have shown longer duration of melatonin     secretion in the winter, similar to the duration seen in healthy women. If these early     findings are confirmed it may explain why SAD is more common in women than in men.      The purpose of this study is to continue researching the differences in melatonin secretion     over the seasons in healthy men and women, and to determine how these findings may apply to     patients with SAD.   "
161884|NCT00001486|"     This large ongoing study at NIMH investigates the neurobiology of schizophrenia by     identifying susceptibility genes, evaluating their impact on brain function to better     understand how to treat and prevent this illness.   "
161885|NCT00001487|"     Dehydroepiandrosterone (DHEA) is a hormone produced by the adrenal gland. As humans grow     older the levels of DHEA naturally decrease. Low levels of DHEA have been associated with a     variety of harmful effects, including increased heart disease, decreased immune system     function, decreased bone density (osteoporosis), high cholesterol, and increased fat to     muscle ratio.      Blood levels of DHEA and its sulfate form, DHEA-S, begin dropping when humans are in their     20's. By the time humans are in their 40's and 50's, levels of DHEA and DHEA-S levels are at     50% of their peak. Previous studies have shown that levels of these hormones are associated     with feelings of well-being and enjoyment of leisure activities.      In this study researchers are interested in the effects on mood and behavior of DHEA in men     and women with mid-life related mood disorders. Specifically, researchers would like to find     out if increasing levels of DHEA will lessen the symptoms associated with these disorders.   "
161886|NCT00001489|"     This study is designed to test the effects of vigabatrin (gamma-vinyl-GABA) an experimental     drug used for the treatment of epilepsy. The study will use positron emission tomography (PET     scan) to detect areas of the brain receiving increased blood flow and using increased amounts     of glucose. Increases in blood flow and glucose use are good indicators of brain activity.      Researchers are interested in determining the effects of Vigabatrin on brain blood flow and     glucose use.   "
161887|NCT00001491|"     Fabry's disease a genetic disorder (X-linked recessive) due to the absence of the enzyme     ceramidetrihexosidase. The disease is characterized by abnormal collections of glycolipids in     cells (histiocytes) within blood vessel walls, tumors on the thighs, buttocks, and genitalia,     decreased sweating, tingling sensations in the extremities, and cataracts. Patients with     Fabry 's disease die from complications of the kidney, heart, or brain.      The purpose of this study is to measure levels of a protein marker (PGP 9.5) in the skin,     blood, and fluid surrounding the brain and spinal cord (CSF) in patients with Fabry's     disease. In addition the study will attempt to determine if levels of the protein are     directly related to the severity of disease in the nervous system.      PGP 9.5 protein levels will be measured in normal volunteers and patients with other diseases     of the nervous system then compared to the levels recorded in patients with Fabry's disease.      This research study is designed to improve the understanding of Fabry's disease. Patients     participating in it will not directly benefit from it. However, knowledge gained as a result     of this study may contribute to the development of effective therapies for Fabry's disease.   "
165661|NCT00006409|"     To test the effectiveness of a multicomponent school-based and community-linked intervention     in preventing the decline in physical activity levels and cardiovascular fitness in girls in     grades 6-8.   "
161898|NCT00001505|"     Background:      -This protocol is concerned with the acquisition of blood, skin, or mucosal samples from     healthy volunteers or patients with selected skin diseases to support the basic science and     clinical research activities of the Dermatology Branch and other intramural Laboratories and     Branches at the NIH Clinical Research Center.      Objectives:      (Primary)      -To allow collection of blood, skin, or mucosal samples from healthy volunteers or patients     with selected skin or systemic diseases as needed to support the research activities of our     Branch and other Laboratories and Branches.      Eligibility:        -  Healthy individuals (including employees and other patients) and patients with selected          skin or other diseases, including individuals of both genders and all racial/ethnic          groups.        -  Patient volunteers must be willing to undergo blood drawing and/or skin/mucosal          biopsies.      Design:      -This is dependent upon the particular investigation for which these samples are needed.   "
162278|NCT00002148|"     To assess the tolerability and safety of OPC-14117. To evaluate effects of OPC-14117 on     cognitive function, quality of life, and activities of daily living.   "
161888|NCT00001493|"     This study examines the feasibility of using gene therapy to prevent some of the toxicities     of an intensive chemotherapy regimen in patients with metastatic breast cancer. Patients who     do not wish to participate in the gene therapy procedures will be offered identical     chemotherapy on a different protocol. Patients will be treated initially with chemotherapy     which is active against breast cancer, but which has a low potential to hurt blood-forming     cells. Then, the patient will receive high dose chemotherapy, during which time blood cells     which are capable of rebuilding patients' bone marrows will be removed from the patients'     bloodstream. We will use these blood cell collections to isolate peripheral blood progenitor     cells (PBPCs), those cells which are thought to be the forbears of all other blood cells.      A portion of the PBPCs will be exposed to a disabled virus which either carries genetic     material referred to as the multidrug resistance gene (MDR1). The virus will transfer the     MDR1 gene into a portion of the patient's PBPCs. The purpose of putting the MDR1 gene into     the patients' PBPCs is to try to make these blood cells and their offspring resistant to the     toxic effects of certain types of breast cancer chemotherapy. The MDR1 protein (Pgp) that is     made from the MDR1 gene makes cells resistant to chemotherapy in laboratory systems by     pumping the drug out of cells before the drug is able to kill the cell. Another portion of     the patients PBPCs will be exposed to a similar disabled virus carrying a different gene     called the NeoR gene. The NeoR gene should not change the effects of chemotherapy on blood     forming cells. The purpose of using the NeoR gene is that it will serve as a point of     comparison, to see if the presence of the MDR1 drug resistance gene really helps blood     forming cells withstand subsequent chemotherapy.      Patients are then treated with a very high dose of another anti-breast cancer drug, one that     is very toxic to bone marrow cells, and patients will then receive the frozen PBPCs, which     contain the new genes, to help them recover from the chemotherapy. After recovery, patients     will then be treated with high doses of paclitaxel (Taxol) and doxorubicin (Adriamycin)     chemotherapy. Both of these drugs are very active against breast cancer, and the MDR1 gene     may potentially protect bone marrow cells against these drugs. Samples of peripheral blood     cells will be obtained before each of these doses of chemotherapy to determine whether the     number of blood cells that contain the MDR1 gene in comparison to the number that contain the     NeoR gene has increased in response to the chemotherapy.   "
161889|NCT00001495|"     This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour     drug-free intervals in patients with solid tumors in order to determine the maximum tolerated     dose of this regimen.   "
161890|NCT00001496|"     Women who are at high risk for breast cancer, either because of linkage to high risk breast     and ovarian cancer families, or because of a carcinoma in the opposite breast, will be     studied. Women will have a physical examination and mammography to ensure that no breast     abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal     breast tissue. Short-term cell cultures will be established from this tissue and early     passages of the short-term cell lines will be stored. A bank of high risk normal mammary     epithelial cells will be established. To further characterize the mammary epithelial cells in     this population of women, cell cultures will subsequently be analyzed for their growth and     metabolic properties, sensitivity to chemopreventive agents, steroid receptor     characteristics, oncogene expression and regulation, and genetic changes.   "
161891|NCT00001497|"     Children with symptomatic HIV-1 (Human Immunodeficiency Virus) infection are at increased     risk for developing severely disabling neurological and neuropsychological deficits. HIV-1     related CNS (Central Nervous System) disease is a clinical syndrome, manifested by varying     and sometimes discordant degrees of cognitive, motor and behavioral impairment. A continuum     of clinical presentations attributed to the effects of HIV-1 infection on the CNS, ranging     from apparently normal development, decreases in the rate of new learning to the loss of     acquired skills have been observed. Two domains of psychological functioning appear most     susceptible to the effects of HIV infection on the central nervous system in children:     expressive behavior and attentional processes (Brouwers, et al, 1994).      Attention deficits have been documented as a relative weakness on the freedom from     distractibility subclass of IQ tests (Brouwers et al, 1989) and on behavior assessment (Moss     et al, 1994). Attention, however, has many subcomponents such as focused attention, divided     attention, vigilance, etc. Direct assessment of attentional functioning using reaction time     has not yet been conducted and questions whether attentional components are differentially     affected by the virus have not been addressed.      The proposed study would assess different components of attentional functioning in children     with HIV-1 disease. A quantitative and systematic method is developed that could complement     the existing standardized instruments used for measuring attention and neurocognitive     function in this population. Simple alerted visual reaction time will be measured with     varying preparatory intervals, a two-choice reaction time in a go/no-go paradigm will be     administered, and a continuous performance, divided reaction time test and an object decision     task will be given. Performance on these measures will also be related to measures of brain     structure and stage of HIV-1 disease.   "
161892|NCT00001498|"     Stage III patients may begin therapy prior to or following surgery. Patients with undrainable     significant third space fluid collection (e.g., pleural effusions, ascites) are entered     directly on Consolidation.      Patients receive induction chemotherapy with methotrexate and fluorouracil every 2 weeks for     4 courses.      Patients then receive two 3-week courses of consolidation therapy with cyclophosphamide,     followed by daily granulocyte colony-stimulating factor until completion of leukapheresis.     Patients next receive myeloablative doses of thiotepa followed by stem cell rescue and     granulocyte colony-stimulating factor.      After hematopoietic reconstitution, patients receive 24-hour infusions of paclitaxel every 3     weeks for 4 doses, followed by doxorubicin or vinblastine every 3 weeks for 4 doses. Patients     are then evaluated for additional therapy (surgery, radiotherapy, or hormonal therapy) as     appropriate.      Patients are followed every 3 months for 1 year, then every 6 months.   "
161893|NCT00001499|"     2-Drug Combination Chemotherapy Followed by Radiotherapy. Paclitaxel, TAX, NSC-125973;     Cisplatin, CDDP, NSC-119875; followed by chest irradiation using 4-15 MV photons.   "
161894|NCT00001500|"     We propose to conduct a multifactorial genetic study of cancer risk-related behaviors and     other complex human characteristics. The main areas of interest are tobacco smoking, excess     alcohol consumption, psychological traits, and HIV/AIDS susceptibility and progression. The     subjects will be adult male and female probands who display one or more of the phenotypes of     interest together with their brothers, sisters and parents. Information on tobacco and     alcohol use, psychological and personality traits, sexual behavior, HIV status and     progression, and other characteristics with possible genetic components will be obtained     through structured interviews and questionnaires. DNA will be prepared from blood samples and     typed for a series of candidate genes chosen for function and for random polymorphic markers.     By correlating the genotypic and phenotypic information, we hope to identify individual loci     that interactively contribute to many different aspects of human health and disease.   "
161895|NCT00001502|"     The presence of a highly selective blood-brain barrier (BBB) at the level of the brain     capillary endothelium prevents chemotherapeutic agents from attaining therapeutic     concentrations at the target site. RMP-7 is a synthetic bradykinin analog which specifically     binds to B2 receptors expressed on the brain capillary endothelial cells and preferentially     increases capillary permeability within CNS tumors. Carboplatin is an anticancer agent with     preclinical and clinical antitumor activity against a variety of brain tumors. A pediatric     phase I trial of the combination of RMP-7 and carboplatin will be conducted to determine the     maximum tolerated dose of RMP-7 in children with refractory brain tumors.   "
161896|NCT00001503|"     This protocol is to provide follow-up medical/surgical visits for DCS patients who are long     term survivors and may not currently be a participant entered on an active research protocol.     No investigational treatments or standard treatments will be administered on this protocol.   "
165737|NCT00005506|"     To investigate the relationship of non-invasively measured flow-mediated brachial artery     dilation with coronary artery disease (CAD).   "
161901|NCT00001509|"     A body of preclinical data has provided a strong rationale for evaluating the combination of     IFN-alpha with retinoic acid. The two drugs have different mechanisms of action and, when     used in combination, show enhanced activity in both adult and pediatric tumor cell lines.      The combination of the antiproliferative and differentiation inducing effect of retinoids     together with the antiproliferative, immunostimulatory and differentiation-potentiating     effects of IFN-alpha warrant clinical investigation of this combination for the treatment of     refractory pediatric malignancies.   "
161902|NCT00001512|"     The idiotype of the immunoglobulin on a given B cell malignancy (Id) can serve as a clonal     marker, and a previous pilot study in lymphoma patients has demonstrated that autologous Id     protein can be formulated into an immunogenic, tumor specific antigen by conjugation to a     carrier protein (KLH) and administration with an emulsion-based adjuvant. The goals of     vaccine development in the current study are to develop vaccines: 1) with improved potency     and 2) which are more effective at inducing cell-mediated immune responses. The selection of     GM-CSF as the immunological adjuvant is a direct extension of our laboratory studies in     small animal models demonstrating that GM-CSF can enhance the potency of the prototype Id-KLH     vaccine by augmenting almost exclusively the cellular arm of the immune response.      The objectives of this study are: 1) to evaluate cellular and humoral immune responses     against the unique idiotype of the patient's lymphoma and 2) to evaluate the ability of the     Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination     or molecular examination (polymerase chain reaction amplification of the rearranged bcl-2     oncogene).      The goal of this study is to treat previously untreated patients with follicular lymphomas to     complete remission or minimal residual disease with ProMACE chemotherapy. Three to six months     after completion of chemotherapy, in an effort to reduce the relapse rate (by eradicating     microscopic disease resistant to chemotherapy), patients will receive an autologous Id     vaccine administered in combination with GM-CSF. Id-KLH (0.5 mg) is administered     subcutaneously. GM-CSF is administered subcutaneously locally with the vaccine on the day of     vaccination and for the three consecutive days following vaccination as close to the initial     vaccination site as possible at one of two doses (patients are randomized to either a high or     low dose, 500 or 100 micrograms/m2).      We plan to accrue 42 patients. Twenty-nine patients have been enrolled. Sixteen patients have     entered and/or completed the vaccination phase. Patients have demonstrated significant     lymphoproliferative responses specific for autologous idiotype of a magnitude which is     significantly greater than previously observed.   "
161903|NCT00001515|"     This study will evaluate a new technique for examining the air passages of the lungs called     virtual bronchoscopy. It involves using computed tomography (CT) images of the chest to     generate a 3-dimensional model of the walls of the trachea and bronchi (airway passages).     This non-invasive method lets doctors see small masses and areas of narrowing in the passages     without having to do surgery or pass a tube through them.      Patients with diseases of the air passages who are enrolled in an NIH clinical trial may     participate in this study, which requires having a CT scan. The patient lies on a table that     slowly slides into a hole in a donut-shaped X-ray machine (the scanner). Patients may have to     hold their breath several times during the procedure. Some patients may be given an injection     of a contrast agent through a catheter (thin tube) placed in an arm vein to improve     visibility of abnormalities. Patients may also be asked to breathe oxygen through nasal     prongs to allow them to hold their breath longer. The procedure usually takes 15 to 20     minutes.   "
161904|NCT00001516|"     This study will evaluate the use of the personal computer (PC) in occupational therapy. The     results of the study will help occupational therapists develop improved treatment activities     using PCs.      Patients enrolled in various NIH clinical trials who are referred for occupational therapy     may be eligible for this study. Each patient will have at least four computer sessions within     6 months. They will use the PC to achieve goals they set for themselves-for example, to build     work skills, improve concentration, or simply have fun. At the end of each session, the     occupational therapist will interview the patient, asking, for example, about the goal of the     session and what may have occurred during the session to make it more helpful or less     helpful. The interviews will be tape recorded and used to help determine how computers may be     used most therapeutically.   "
161905|NCT00001518|"     The Groshong and Groshong PICC catheters are popular venous access devices because they are     maintained with only weekly saline flushes. In a recent study, however, we found an apparent     decrease in the rate of withdrawal occlusion in Groshong catheters flushed weekly with     heparinized saline. However, a randomized trial is necessary to confirm this impression. In     the current study as many as 66 patients will be randomized to each of two treatment arms.     The Groshong catheters of one group will be flushed with saline only and the other group with     heparinized saline. A comparison will be made between the frequency with which urokinase is     used in the two groups to treat withdrawal occlusion during the first three months of     catheterization. Groshong catheters using saline flushes will be compared to Groshong     catheters using heparinized saline flushes and Groshong PICC catheters using saline flushes     will be compared to Groshong PICC catheters using heparinized saline flushes. Data will be     analyzed using Fisher's exact test.   "
162079|NCT00001071|"     To determine the safety of stem cell harvesting after administration of filgrastim ( G-CSF )     to mobilize bone marrow stem cells into the peripheral blood in patients at various stages of     HIV-1 infection as well as in HIV-negative volunteers. To determine the surface phenotypic     and functional characteristics as well as the viral load in the stem cells obtained following     this procedure.   "
165738|NCT00005507|"     To study the causes of persistent differences in Black-white access to tertiary care     cardiovascular surgical services (TCCS).   "
161910|NCT00001523|"     Therapeutic irradiation to the head and neck for cancer damages salivary glands present in     the radiation field. Despite long recognition of radiation-induced salivary hypofunction, and     the associated oral morbidities, the specific damage mechanism(s) is not known and the     structure and functional integrity of the surviving parenchymal tissue has not been     well-documented. Detailed knowledge of the latter is particularly necessary in order to     design appropriate corrective therapies. It is the purpose of this study to provide such a     detailed structural and functional assessment of human parotid glands following irradiation.     The study will examine 20 patients beginning just prior to therapeutic irradiation and     continuing at intervals for 3 years for a total of 5 study visits. Study visits (prior to     irradiation and at 4 weeks, 12 weeks, 12 months and 36 months post-irradiation) will include     the following procedures: i) detailed oral exam and structured interview; ii) salivary gland     functional assessment; iii) sialography of each parotid gland; iv) 99mTcO4 scan of the     salivary glands; and v) a magnetic resonance imaging (MRI) scan of the parotid glands. Based     on previous single observation studies in humans, and more detailed animal studies, we     hypothesize that ionizing radiation will lead to reduced parotid gland function and     diminished salivary parenchymal tissue (with a preferential loss in acinar versus ductal     cells). Further, we hypothesize that the parenchymal loss will increase with time (replaced     by fat and connective tissue) and lead to progressive irreversible salivary dysfunction.   "
161906|NCT00001519|"     Measurements of dynamic changes in oxygen uptake (VO2 kinetics) during recovery from exercise     may describe regulatory control of oxygen transport and utilization and have greater     reliability and less inherent risk than assessment of maximal oxygen uptake (VO2max) in     patients for whom exercise is limited by pain, excessive fatigue, dyspnea and motivation. The     purpose of this pilot study is to evaluate the effect of exercise intensity on the time     constant describing changes in VO2 (tauVO2) during recovery from one minute of constant work     rate exercise. Five normal healthy volunteers ages 18 and older will perform a progressive     maximal aerobic exercise test, using a cycle ergometer, to determine VO2max and lactate     threshold (LT) estimated by gas exchange. Each subject will also complete a series of maximal     constant work rate tests and submaximal constant work rate tests at 80% LT and 50% of the     difference between LT and VO2max (50% delta). Breath by breath variability and VO2 span will     be used to determine the number of constant work rate test repetitions, for each subject for     each exercise intensity, needed to establish confidence in tauVO2. A mean response profile of     VO2 recovery kinetics for each exercise intensity will be analyzed using non-linear     regression to determine tauVO2. To examine the effect of exercise intensity on tauVO2, one     way analysis of variance will be used to determine whether differences exist among maximal     and submaximal (80% LT and 50% delta) time constants. We hypothesize that there will be no     significant differences among time constants for VO2 during recovery from maximal and     submaximal constant work rate exercise lasting one minute. The results of this study are     expected to provide increased understanding of the measurement of VO2 kinetics during     recovery.   "
161907|NCT00001520|"     Neuromuscular blocking agents are commonly used to facilitate endotracheal intubation.     Succinylcholine, an ultra short-acting, depolarizing neuromuscular blocking agent, is the     most commonly used agent for paralysis in this setting because of its rapid onset and short     duration of paralysis. In patients with contraindications to succinylcholine or in whom a     difficult airway is anticipated, a neuromuscular blocking agent with a pharmacodynamic     profile similar to succinylcholine would be an attractive alternative. Rocuronium, a new     intermediate-acting nondepolarizing neuromuscular blocking agent produces paralysis within 60     seconds, similar to succinylcholine, but has a duration of paralysis of approximately 20 to     30 minutes. If rocuronium-induced paralysis could be chemically reversed within 10 to 15     minutes after the administration of an intubating dose, it may be an appropriate alternative     in patients with contraindications to succinylcholine or in patients whom a difficult airway     is anticipated. Neostigmine is an anticholinesterase agent which inhibits the hydrolysis of     acetylcholine by competing with acetylcholine for attachment to acetylcholinesterase.     Inhibition of the breakdown of acetylcholine allows the neurotransmitter to be present in the     neuromuscular junction for a longer period of time, so that each molecule can bind repeatedly     with the acetylcholine receptor. The purpose of this study is to determine the dose of     neostigmine necessary for the early reversal of rocuronium-induced paralysis.   "
161908|NCT00001521|"     This study was developed to determine if a combination of four drugs (flutamide,     testolactone, reduced hydrocortisone dose, and fludrocortisone) can normalize growth in     children with congenital adrenal hyperplasia.      The study will take 60 children, boys and girls and divide them into 2 groups based on the     medications given. Group one will receive the new four- drug combination. Group two will     receive the standard treatment for congenital adrenal hyperplasia (hydrocortisone and     fludrocortisone).      The boys in group one will take the medication until the age of 14 at which time they will     stop taking the four drug combination and begin receiving the standard treatment for     congenital adrenal hyperplasia. Girls in group one will take the four drug combination until     the age of 13, at which time they will stop and begin receiving the standard treatment for     congenital adrenal hyperplasia plus flutamide. Flutamide will be given to the girls until six     months after their first menstrual period.      All of the children will be followed until they reach their final adult height. The     effectiveness of the treatment will be determined by measuring the patient's adult height,     body mass index, and bone density. <TAB>   "
161909|NCT00001522|"     This study focuses on the way weight is gained. Individuals who gain weight primarily in     their midsection (visceral weight) are at an increased risk for developing diabetes and high     blood pressure.      Research has shown that African Americans suffer more often from high blood pressure,     diabetes (non-insulin dependent), and heart disease than Caucasian Americans. These     conditions lead to significant numbers of deaths and diseases associated with and made worse     by obesity.      African American women in particular suffer from obesity and the associated conditions of     obesity more than any other race or gender. However, it is unknown if the conditions seen in     African American women are a result of the obesity or differences in their insulin     sensitivity, glucose disposal, or fat metabolism.      This study will compare body composition, total and resting energy expenditure, and glucose     disposal of obese African American and Caucasian children and of non-obese children of obese     African American and Caucasian parents, to characterize the timing and nature of factors that     may contribute to the prevalence of obesity and its complications.      Patients participating in this study will be followed for 15 years and be evaluated every 5     years during the study.<TAB>   "
161914|NCT00001528|"     This study is designed to examine the blood flow, the nutrition, and the beating function of     the heart under different conditions. Patients with narrowed coronary arteries my have     restricted blood flow to the heart. The lowered blood supply to the heart muscle may not     cause symptoms immediately. However, as the heart pumps faster and harder the blood supply     demand is increased. If blood flow is unable supply enough oxygen and nutrition to heart     muscle patients can experience symptoms of chest pain and shortness of breath. Even after the     heart slows down and demand for oxygen and nutrition is reduced, patients can still     experience pain and abnormal heart function.      The purpose of this study is to determine the changes in blood flow and the beating function     of the heart during periods of increased demands (such as exercise) and shortly after     stopping exercise.      Blood flow to the heart will be measured by positron emission tomography (PET scan). The PET     scan is a test where a small amount of radioactive water is injected into the bloodstream and     pictures of the heart are taken by the special camera. This procedure allows researchers to     measure blood flow to heart muscle. In order to measure nutrition (metabolism) of the heart     muscle, researchers will use a radioactive substance similar to sugar (Fluorodeoxyglucose).      Results of this study may provide important information about the activity and function of     heart muscle after exercise in patients suffering from coronary artery disease.   "
161911|NCT00001524|"     This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV     infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day.     However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased     viral load, and even nerve damage that may not be reversible. This study will evaluate the     efficacy of a topical formulation of thalidomide (placed directly on the surface of the sore)     for the healing of these sores.      Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one     or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be     referred by a primary care physician who is managing their care, and must have HIV/AIDS     status confirmed. Patients' HIV treatment regimen will not be altered and those receiving     highly active therapy will not be excluded.      Patients will be excluded if they are concurrently being treated for mucosal lesions     (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals,     or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or radiation     therapy for neoplasms; using concurrent acute therapy for opportunistic infections;     concurrent use of sedatives (such as CNS depressants or alcohol use); history of allergy to     thalidomide; pre-existing peripheral neuropathy of grade II or higher; pregnant or lactating     females or those not practicing contraception according to FDA guidelines for thalidomide.   "
161912|NCT00001526|"     Uveitis refers to intraocular inflammatory diseases that are an important cause of visual     loss. Standard systemic immunosuppressive medications for uveitis can cause significant     adverse effects. Consequently, an effective treatment with a safer side effect profile is     highly desirable.      This pilot study has permitted enrollment of up to 12 adults with non-infectious intermediate     or posterior uveitis who require treatments to maintain visual function. This extended     protocol began with an evaluation of the safety and potential efficacy of intravenous (IV)     daclizumab treatments for uveitis while reducing or eliminating standard medications     commensurate with the standard of care. As subcutaneous (SC) daclizumab treatments become     available, eligible participants will be offered continuing daclizumab treatments using the     new SC formulation, though they may elect to remain on the IV treatments. If the therapeutic     benefit is sustained using the SC formulation, maintenance therapy will continue as     clinically indicated. Participants who repeatedly fail the SC therapy will be permitted to     revert to the IV daclizumab regimen they previously used, or may exit the study as treatment     failures. SC treatments begin with a short SC induction at 2 mg/kg followed by 1 mg/kg     treatments on a 4-week schedule as the protocol originally specified. Participants will be     monitored routinely when each dose is received and additionally will participate in     pharmacokinetic studies to monitor SC formulation bioavailability.      Daclizumab is a humanized anti-Tac monoclonal antibody (HAT, Zenapax) that interferes with     inflammatory processes by its involvement with the interleukin 2 receptor (IL-2R). During the     first 5 years of this study, only an IV product was available. The SC formulation is now     available containing the same daclizumab drug product. Preliminary studies indicate that the     SC formulation is well tolerated by normal control subjects and other autoimmune disease     patients at repeated doses up to 2 mg/kg.      The primary objectives are to examine the safety and potential efficacy of IV and later, SC     daclizumab, while continuing to reduce other immunosuppressive medications commensurate with     the standard of care. Primary safety outcomes are the discontinuation of study therapy due to     reduced vision or the occurrence of adverse events. Secondary outcome measures include visual     acuity and the grading of immunosuppressive medications, anterior chamber and vitreous cells,     and vitreous haze.   "
161913|NCT00001527|"     Endothelin-1 (ET-1) is a powerful vasoconstricting peptide produced predominantly by vascular     endothelial cells, that exerts its effect through the interaction with specific receptors,     ETA and ETB, on the underlying smooth muscle cells. Previous studies in normal subjects have     demonstrated an increase in forearm blood flow after ET-1 antagonism, suggesting a     physiologic role of ET-1 in the regulation of basal vascular tone. However, whether     ET-1-mediated tone is increased in hypertensive patients is unknown.      The main purpose of this study will be to compare the forearm vascular responses to local     infusion of ET-1 receptor antagonists between normotensive and hypertensive subjects in order     to assess whether ET-1-mediated basal tone is increased in patients with hypertension. In     addition, we propose to study the vascular responses to local ET-1 infusion to determine     whether vascular smooth muscle sensitivity to this peptide is increased in hypertensive     vessels. We will use both an ETA receptor antagonist, BQ-123, and an ETB receptor antagonist,     BQ-788, in order to evaluate the relative contribution of the two receptor subtypes to the     regulation of vascular tone.      All drugs will be infused into the brachial artery and the responses of the forearm     vasculature will be measured by means of strain gauge plethysmography. Because of the     relative long-lasting effect of most of the substances to be infused, the study will be     performed on two separate occasions.   "
161929|NCT00001544|"     The purpose of this study is to improve the understanding of the genetic causes of specific     neurologic and psychiatric disorders. The study will focus on conditions of mental     retardation, childhood onset schizophrenia, attention deficit hyperactivity disorder (ADHD),     atypical psychosis of childhood, and bipolar affective disorder.      The study addresses the belief that there may be several genes contributing to the illness.     Researchers intend to use several molecular genetic techniques in order to identify the areas     of chromosomes containing genes responsible for the development of these disorders.      Patients will be selected to participate in this study based on an early age of onset of     their condition as well as the severity of the illness and the frequency of the illness among     family members. Researchers will collect DNA samples from patients as well as affected and     unaffected family members of each patient. The DNA samples collected will be analyzed for a     variety of genetic abnormalities including; triplet repeat expansions, chromosome     rearrangements, and polymorphisms.   "
161915|NCT00001529|"     Bone marrow transplants (BMT) are one form of treatment for disorders of the blood, including     leukemia. However, because the procedure is often associated with potentially     life-threatening reactions, it is usually reserved for patients with serious illnesses under     the age of 60 years old.      One serious reaction complicating bone marrow transplants is referred to as graft-versus-host     disease (GVHD). GVHD is a potentially fatal incompatibility reaction. The reaction is caused     by antigens found on the cells of the patient that are not present on the cells of the donor.     The antigens are recognized by transplanted white blood cells (lymphocytes). These     lymphocytes begin attacking the recipient s cells and tissues and may lead to death.      In order to avoid GVHD, researchers have developed a technique using peripheral blood instead     of bone marrow that allows transplantation of stem cells and removal of lymphocytes. Stem     cells are the cells responsible for returning blood cell production to normal. Lymphocytes     are the white blood cells that can cause GVHD.      The technique requires two steps. In the first step blood cells are collected from donors who     have received doses of a growth factor. The growth factor (granulocyte colony stimulating     factor) is designed to increase the production of donor stem cells.      In the second step white blood cell lymphocytes are removed from the collected blood, leaving     only the stem cells.      The main goal of this study is to develop and improve the method of processing cells that are     collected after stimulation with growth factor (G-CSF), by removing the white blood cell     lymphocytes which can cause graft-versus-host disease (GVHD) while keeping the stem cells     necessary for healthy blood cell building. In addition, researchers are interested in     studying whether giving G-CSF has an effect on lymphocyte function, which may influence the     immune reactions occurring in bone marrow transplantation.   "
162008|NCT00000999|"     To obtain information about the long-term safety and toxicity of zidovudine (AZT). To     ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT     toxicity.      Because of the high incidence of toxicity and the relatively short-term follow-up of the     patients due to the early ending of the Phase II placebo-controlled experiment, it is     valuable to continue to get information on the long-term toxicity of AZT.   "
161916|NCT00001530|"     DDD pacing improves symptoms and relieves LV outflow tract (LVOT) obstruction in most     patients with hypertrophic cardiomyopathy (HCM). Notably, when pacing is temporarily     discontinued, the beneficial effects of pacing are evident in sinus rhythm. The long term     results of this novel therapy are, however, uncertain. We propose (1) to record the     hemodynamic changes following >4 years of pacing; and (2) to determine whether DDD pacing     continues to be necessary in patients who have had a substantial relief of their LVOT     obstruction. Patients who have had >50% reduction in LVOT pressure gradients will be     randomized to two pacing modalities: DDD at 70 beats per minute and AAI pacing at 70 beats     per minute (DDD switched off), and reevaluated after a six-month period.   "
161917|NCT00001531|"     The purpose of this study is to investigate whether the susceptibility of subjects to     atherosclerosis is influenced by prior CMV exposure, whether the susceptability to     endothelial dysfunction in patients with and in patients without atherosclerosis is     influenced by prior CMV exposure.   "
161918|NCT00001532|"     This study is designed to evaluate the genetics involved in the development of lung disease     by surveying genes involved in the process of breathing and examining the genes in lung cells     of patients with lung disease.      The study will focus on defining the distribution of abnormal genes responsible for processes     directly involved in different diseases affecting the lungs of patients and healthy     volunteers.   "
161919|NCT00001533|"     T Cell Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders are a heterogeneous     group of uncommon diseases which may involve a polyclonal or a monoclonal T cell population,     which bear characteristic surface markers corresponding to activated cytotoxic (CD3+, CD8+)     lymphocytes. They are often associated with quite severe neutropenia, anemia, and     thrombocytopenia which may be life-threatening. There is some evidence that the abnormal     cytotoxic lymphocyte population may cause the cytopenias by suppressing hematopoiesis,     although the mechanism is unclear. Case reports suggest that immunosuppressive therapy     directed toward T cells may reverse the cytopenia. This pilot study involving up to 25     patients evaluates the clinical response to cyclosporine, an immunosuppressive drug, and     seeks to elucidate the mechanism underlying the cytopenia.   "
161920|NCT00001534|"     The human heart is divided into four chambers. One of the four chambers, the left ventricle,     is the chamber mainly responsible for pumping blood out of the heart into circulation.     Hypertrophic cardiomyopathy (HCM) is a genetically inherited disease causing an abnormal     thickening of the heart muscle, especially the muscle making up the left ventricle. When the     left ventricle becomes abnormally large it is called left ventricular hypertrophy (LVH). This     condition can cause symptoms of chest pain, shortness of breath, fatigue, and heart beat     palpitations.      This study is designed to compare the ability of two drugs (enalapril and losartan) to     improve symptoms and heart function of patients diagnosed with hypertrophic cardiomyopathy     (HCM).      Researchers have decided to compare these drugs because each one has been used to treat     patients with other diseases causing thickening of the heart muscle. In these other     conditions, enalapril and losartan have improved symptoms, decreased the thickness of heart     muscle, improved blood flow and supply to the heart muscle, and improved the pumping action     of the heart muscle.      In this study researchers will compare the effectiveness of enalapril and losartan when given     separately and together to patients with hypertrophic cardiomyopathy (HCM).   "
161921|NCT00001535|"     This study will test the safety and effectiveness of genetically altered T lymphocytes (white     blood cells of the immune system) in reducing viral load in patients infected with the human     immunodeficiency virus (HIV). The lymphocytes will have two genes inserted into them; a     laboratory-manufactured anti-HIV gene designed to inhibit HIV reproduction (either the RevTD     or Rev-TD-antiTAR gene), and a marker gene that will show whether or not the inserted genes     have gotten into the cells.      Identical twin pairs 18 years of age and older- one of whom is HIV-positive (infected with     the human immunodeficiency virus) and the other HIV-negative (not infected) may be eligible     for this study.      All participants will have a complete medical history and physical examination, blood tests     and a tetanus booster shot, if indicated. The non HIV-infected twin will then undergo     lymphapheresis to collect lymphocytes. In this procedure, whole blood is collected through a     needle placed in an arm vein. The blood circulates through a machine that separates it into     its components. The lymphocytes are then removed, and the red cells and plasma are returned     to the donor, either through the same needle or through a second needle placed in the other     arm.      The donor cells are grown in the laboratory for a few days, and then the new genes are     inserted into them. The genetically altered cells are grown in the laboratory for several     days until their numbers increase approximately a thousand-fold. They are then infused     intravenously (through a vein) into the infected twin. These procedures-lymphapheresis, gene     modification and infusion-will be repeated at approximately 2-month intervals up to four     times.      Each lymphocyte infusion takes about 60 minutes. The patient's vital signs (temperature,     pulse, blood pressure and breathing) are monitored frequently during the infusion and hourly     for 4 hours after the infusion. Blood samples are taken the day of the infusion, 3 days     later, and then weekly to monitor the gene-modified cells, immune status, viral activity, and     other factors. These tests may be done less often as the study progresses and more is learned     about the safety of the infusions. The infusions are done on an outpatient basis unless side     effects require that they be done in the hospital with post-infusion monitoring for at least     24 hours.      Patients will be followed for long-term effects of treatment monthly for the first 3 months,     once a month for the next 9 months and yearly from then on.      This study will contribute information about the use and side effects of gene therapy in HIV     infection that may lead to new treatment strategies. A potential direct benefit to     HIV-infected individuals participating in this study is reduced viral load; in laboratory     studies, the RevTD and Rev-TD-antiTAR genes have inhibited HIV spread in the test tube.     However, this is an early phase of study, and the likelihood of receiving this benefit is     unknown.   "
162080|NCT00001072|"     To evaluate, in HIV-negative volunteers, the safety and immunogenicity of ALVAC-HIV     MN120TMGNP (vCP300) followed by or combined with boosting using rgp120/HIV-1SF2. To compare     ALVAC-HIV vCP300 with ALVAC-RG rabies glycoprotein (vCP65) as a control. To evaluate an     accelerated immunization schedule at 0, 1, 3, and 6 months versus 0, 1, 6, and 9 months.      The combination of a live recombinant primer followed by a subunit boost has the potential to     induce not only cytotoxic T lymphocytes but also neutralizing antibody.   "
161936|NCT00001551|"     According to studies, speech disorders with unknown causes (idiopathic) affect approximately     5% of the population at some point in their life. Some of these disorders like, stuttering     and cluttering, are known for being detected early, during speech development.      Stuttering is characterized by sound and syllable repetitions and consonant/vowel     prolongations. When stuttering is moderate to severe, it can interfere with a person's job     and social activities.      Speech articulation disorders are characterized by omissions, or substitutions of speech     sounds. The speech of a person who clutters is often difficult to understand. People are     often unaware of the errors they make when speaking causing treatment of the condition to be     very difficult.      The purpose of this research is to study an extended family whose members exhibit a pure form     of speech articulation disorders      In addition, the study will use data and information gathered from the study and use it to     develop guidelines (criteria) for defining and differentiating patients with speech     disorders.   "
161922|NCT00001536|"     Since the gene responsible for achondroplasia was identified in 1994, it has become possible     to test for achondroplasia prenatally. Moreover, prenatal genetic testing for achondroplasia     is relatively simple and is highly likely to be informative for any couple seeking testing.     Four diagnostic laboratories in the U.S. are currently performing prenatal genetic testing     for achondroplasia. Before prenatal genetic testing for achondroplasia becomes more widely     available, however, it is essential that we learn more about the lives of affected     individuals and their families, the implications of offering testing for achondroplasia, and     the education and the counseling needs of this community. Personal interviews and stories     have been published and discussed at national meetings (Ablon 1984). We conducted a pilot     telephone interview survey of 15 individuals with achondroplasia. What is needed now is a     large scale quantitative study of the community of little people and their families. To meet     this need, we have developed a survey tool to analyze family relationships, quality of life,     tendencies toward optimism or pessimism, information-avoiding or information-seeking     behaviors, social support, involvement in Little People of America Inc. (LPA), self-esteem,     sociodemographics and views on achondroplasia, religiousness, reproductive and family plans,     genetic testing, and abortion. The self-administered survey will be completed nationally by a     sample of persons with achondroplasia and their family members.   "
161923|NCT00001538|"     This is a randomized, double blind study of the safety and immunogenicity of APL 400-003, a     plasmid DNA vaccine encoding the env and rev genes of HIV-1, in HIV-negative volunteers.     Three doses of vaccine are being tested: 100, 300, and 1000 micro g. 8 volunteers per dose     will be randomized: 6 to plasmid vaccine, and 2 to a vehicle control. Immunizations will be     administered at day 0 and weeks 4 and 8, with a booster immunization administered at week 24.     An additional 5 volunteers may be included in an open manner at the dose likely to be used in     subsequent studies. The primary aims of the study are to determine: 1. the safety of APL     400-003, as evaluated by clinical and laboratory safety parameters and 2. the immunogenicity     of APL 400-003, as determined by a broad range of laboratory assays. Up to 33 patients     (allowing for drop-outs) will be enrolled in the study, and volunteers will be followed for     one year after immunization.   "
161924|NCT00001539|"     This study will determine whether patients who have been infected with the Lyme bacteria,     Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them     and whether it is causing their symptoms. The information from this study may serve as a     basis for developing stringent diagnostic criteria for Lyme disease and the establishment of     future treatment trials.      Individuals in the following categories may be eligible for this study: chronic Lyme disease;     chronic Lyme arthritis; seropositive control (are infected with the bacteria that causes Lyme     disease but do not have disease symptoms); recovered control (have been sick with Lyme     disease but were treated successfully and are currently well); control with multiple     sclerosis (patients with multiple sclerosis); and healthy volunteers. Patients in the chronic     Lyme disease category must be age 13 and above; all others must be age18 and above.     Candidates will be screened with blood and urine tests.      Participants will have a physical examination and the following tests:      Blood tests Includes HLA-typing, a genetic test of immune system markers;      Leukapheresis Collection of large numbers of white blood cells Whole blood is collected     through a needle in an arm vein. The blood circulates through a machine that separates it     into its components. The white cells are removed and the rest of the blood is returned to the     body, either through the same needle used to draw the blood or through another needle in the     other arm. (Alternatively, patients will 100 cc (about 7 tablespoons) of blood drawn.);      Lumbar puncture (spinal tap) Collection of cerebrospinal fluid (CSF, fluid that bathes the     brain and spinal cord). A local anesthetic is administered and a needle is inserted in the     space between the bones in the lower back where the cerebrospinal fluid circulates below the     spinal cord. A small amount of fluid is collected through the needle;      Magnetic resonance imaging (MRI) of the brain Imaging of the brain using a strong magnetic     field and radio waves instead of X-rays. During the scan, the patient lies on a table in a     narrow cylinder containing a magnetic field. He or she can speak with a staff member via an     intercom at all times during the procedure;      Neuropsychologic testing;      Some participants may also have a hearing test and urine collection.      Participants whose test results are positive for Borrelia burgdorferi will be followed at NIH     at intervals of 3 to 6 months until it is determined whether there is infection. Those who     are infected will be offered treatment with the antibiotic ceftriaxone. Following treatment,     patients will return to the NIH Clinical Center for follow-up visits 1 week after treatment     and again at 3, 6 and 12 months. The lumbar puncture, hearing examination, blood and urine     tests will be repeated at these visits to evaluate the response to treatment, and the     leukapheresis will be repeated for research purposes. Patients whose MRI was abnormal during     therapy will have a repeat MRI at the 3-month, 6-month and 1-year visits.      All participants with chronic Lyme disease, chronic Lyme arthritis, seropositive controls and     recovered controls may be reevaluated at intervals of 6 to 12 months.   "
161925|NCT00001540|"     The objective of this study is to evaluate the safety and utility of bacteriophage phi X174     immunization as a tool to assess the immune competence of HIV-infected patients at different     stages of disease in vivo, and to assess the impact of viral load levels and therapy-induced     changes in viral load levels on the response to immunization with the neo-antigen     bacteriophage phi X174. Bacteriophage phi X174 immunization is a method that has been in use     for more than 25 years to assess the immunity of patients with various types of primary and     secondary immunodeficiencies, including 48 HIV-infected patients. This is a prospective     open-label, controlled study which will enroll 39 HIV-infected patients and 13 healthy     volunteers, male or female with 18 years of age and over. The HIV-infected patients will be     divided into 3 groups according to their CD4 cell count: less than 200 cells/mm(3), between     200 and 500 cells/mm(3) and greater than 500 cells/mm(3). After screening and a two week     pre-study evaluation, all eligible participants will receive a primary, secondary and     tertiary immunization with 2 x 10(9) PFU/kg of bacteriophage phi X174 six weeks apart.     Patients who present with detectable levels of viral load at entry will be offered a more     effective antiviral drug regimen. Patients will have to be on a stable antiviral regimen for     at least one month prior to receiving the primary immunization. Patients will return for     visits 1, 2 and 4 weeks after each immunization for clinical and laboratory evaluations. The     study endpoints are: safety (as measured by incidence of adverse events, CD4 cell count and     HIV plasma RNA), kinetics of bacteriophage clearance following primary immunization,     quantitation of bacteriophage phi X174 specific antibody titers following primary, secondary     and tertiary immunizations and determination of qualitative and quantitative antibody isotype     switching following secondary and tertiary immunizations.   "
161926|NCT00001541|"     This study will collect fluid and tissue samples from the bronchi (air passages to the lungs)     of patients with Wegener's granulomatosis for laboratory examination. Wegener's     granulomatosis is a type of vasculitis (blood vessel inflammation) that can affect many parts     of the body, including the brain, nerves, eyes, skin, sinuses, kidneys, intestinal tract,     joints, heart, lungs and other sites. About 85 percent of patients have lung involvement. The     lining of the bronchi (bronchial mucosa) is composed of cells that produce mucus,     inflammatory cells, and inflammatory mediators (chemicals produced in response to     inflammation). Analysis of these various substances may provide insight into what causes     different types of lung problems in Wegener's granulomatosis.      Patients between 18 and 75 years of age with Wegener's granulomatosis who require     bronchoscopy to evaluate the cause of their lung problem may be eligible for this study.      Participants will undergo a bronchoscopy in the hospital intensive care unit (ICU). For this     procedure, the mouth and throat are numbed with lidocaine jelly and spray. If needed, a     sedative is given for comfort. A small plastic tube (intravenous catheter) is placed in a     vein to give medications. A pencil-thin tube is then placed through the nose or mouth into     the lung airways to examine the airways carefully.      At the time of the bronchoscopy, patients in this study will undergo the following additional     procedures:        -  Bronchoalveolar lavage - Saline (salt water) is injected through the bronchoscope into          the air passage, acting as a rinse. A sample of the fluid is then withdrawn and examined          for infection, inflammatory cells and inflammatory chemicals. (This may be done as part          of the standard medical care procedure.)        -  Bronchial lavage - This procedure is similar to bronchoalveolar lavage, but less fluid          is used to rinse larger airways.        -  Bronchial mucosal biopsies - A small wire is inserted through the bronchoscope next to          the bronchial lining. Forceps at the end of the wire pinch off a small piece of tissue          for withdrawal and examination.      The patient's heart rhythm and rate and oxygen levels are monitored during the procedure.     When the procedures are finished, the patient is monitored in the ICU until the numbing     effect of the anesthetic has worn off and then moves to a regular hospital bed for overnight.      Patients whose test results show an isolated infection or isolated Wegener's lung tissue     involvement and who are being treated or are eligible for treatment under another NIH     protocol will be followed by X-ray for improvement of their infection or other lung     involvement with treatment. Patients whose infection or lung tissue involvement improves may     be asked to undergo a second bronchoscopy as described above, but for research purposes only.   "
161927|NCT00001542|"     This is a placebo-controlled trial of intermittent fluconazole prophylaxis (200 mg orally     three times a week) in the prevention of thrush.   "
161928|NCT00001543|"     This is a study investigating the hormones and substances important to the stress response.     The hormone that is most directly responsible for stress response is called     corticotropin-releasing hormone (CRH). CRH is produced in the hypothalamus of the brain and     causes the pituitary gland to produce another hormone called ACTH. The hormone ACTH then acts     on the adrenal glands causing them to produce the hormone cortisol.      Unfortunately, CRH levels are unable to be measured in simple blood samples. However,     substances like cortisol and leptin can provide information as to the activity of the     hypothalamus.      The hormone leptin is associated with the regulation of body weight and the normal     maintenance of bodily functions (homeostasis). It is found in fat cell (adipocyes) and     communicates the nutritional status of the body to the brain (central nervous system).     Research using animals has shown that defects in the communication between leptin and the     brain causes obesity (the state of being overweight). It has also been noted that obese     humans tend to have high levels of leptin.      By studying patients with abnormal genes responsible for leptin production, researchers have     found that a least one leptin gene must be intact for the normal secretion of hormones to     proceed. These results show that the hormone leptin is produced outside of the brain in fat     cells and acts directly on the function of the hypothalamus within the brain. Researchers     believe that leptin plays a key role in the normal release of hormones from the HPA axis.      Researchers intend on continuing to study the role of leptin in fat distribution, and the     activity of the HPA axis in normal volunteers. In addition, this study will focus on the role     of leptin in depression, because depression is characterized by changes in food intake, body     weight, and neuroendocrine function. Data gathered from this study will provide a better     understanding of the causes and medical consequences of major depression.   "
162171|NCT00002041|"     To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To     compare the effectiveness of two different amphotericin B doses in the treatment of     biopsy-proven Candida esophagitis. To determine if low-dose amphotericin B is less toxic than     standard dose therapy during a limited treatment period. To evaluate pharmacokinetic and     pharmacodynamic parameters of the two different dosing regimens.   "
161930|NCT00001545|"     This study is designed to evaluate repetitive transcranial magnetic stimulation (rTMS) as a     potential treatment for depression. In rTMS, a rapidly changing magnetic field passes through     your scalp and skull and generates a small electrical pulses in your brain. rTMS at lower     intensities has helped some people with depression but we do not know what the results will     be in your case using higher intensities, or whether you will be randomized to 3 weeks of     high frequency (20 cycles er second), low frequency (1 cycle per second), or inactive     (sham)rTMS. You will be assigned to receive one of these types of rTMS over the left front     art of your brain five times per week for the three weeks. Each rTMS treatment session should     take between 20-30 minutes of actual stimulation, but weekly ratings, memory testing, and     blood sampling may require several hours per week. We will also ask you to have brain imaging     procedures to see if these will predict response to high vs. low frequency rTMS. If you are     randomized to the 3 weeks of sham rTMS, you will have the opportunity to receive one of the     active stimulation frequencies for an additional 3 weeks. Responders to any phase will be     offered an additional month of rTMS prior to study termination and recommendations of     alternative treatments.   "
161931|NCT00001546|"     Routine sleep duration varies greatly among individuals. The biological meaning of this     variation is unknown.      The term circadian rhythm refers to the biological clock that regulates the timing of falling     asleep, waking up, and secretion of hormones, like melatonin. Melatonin is secreted at night.     Previous studies have shown that melatonin may play a role in the regulation of sleep.      The purpose of this study is to learn whether the duration of nighttime (nocturnal) melatonin     secretion is longer in people with long regular sleep duration than people with short sleep     duration.      Researchers will compare levels of melatonin and cortisol, body temperature, sleepiness, and     sleep in two extreme groups. Group one will be made up of people with short sleep duration     lasting less than 6 hours. Group two will be made up of people with long sleep duration     lasting more than 9 hours.   "
161932|NCT00001547|"     Use of the drug interferon-alpha (IFN-A), is associated with frequent and well characterized     side effects like neurotoxicity. Neurotoxicity can cause symptoms of depression, agitation,     anxiety, and/or confusion.      The NIDDK is conducting a research study called, Combination of Alpha Interferon with Long     Term Ribavirin Therapy for Patients with Chronic Hepatitis C (98-DK-0003). Patients     participating in it are receiving interferon-alpha in addition to an antiviral medication     called ribavirin. Researchers at the NIMH intend to study patients to learn more about how     different medications can influence mood, thoughts and behavior.      The primary purpose of this study is to determine if treatment with IFN-A in combination with     ribavirin alters human brain biochemistry as measured by proton magnetic resonance     spectroscopy (MRS).      MRS uses strong magnetic fields in order to measure biochemical products of metabolism found     in the brain. Researchers intend to perform MRS scans before, during, and after patients     receive their medications      Researchers believe that the combination of IFN-A/Ribavirin will directly affect specific     areas of the brain and as a result, some patients will develop specific mood or cognitive     symptoms. Patients often must stop taking these medications because of the side effects.      This study will not contribute directly to the treatment of patient's Hepatitis C condition.     However, the information gathered from this study will help researchers better understand the     neuropsychiatric affects associated with interferon alpha and ribavirin therapy.   "
161933|NCT00001548|"     The purpose of this study is to identify genes that affect susceptibility to     obsessive-compulsive disorder (OCD). By identifying genes that increase or decrease the risk     of OCD, researchers can better understand how the condition develops and ultimately improve     treatment for people with OCD.      OCD is a severe, familial condition that affects approximately 2% of the population. The way     OCD is inherited is not clearly understood, but researchers believe it is complex and     involves multiple genes. This study will detect and localize genes that increase or decrease     susceptibility to OCD. The data collected from this study will be combined with data from     other research studies to determine gene linkage and association.   "
161934|NCT00001549|"     The purpose of this study is to improve understanding of neurological conditions. Patients     participating in this study will continue receiving medical care, routine laboratory tests,     and diagnostics tests (X-rays, CT-scans, and nuclear imaging), from their primary care     physician. Doctors at the NIH plan to follow these patients and offer advice and assistance     to their primary care physicians.   "
161935|NCT00001550|"     Stiff-man Syndrome (SMS) is a chronic, progressive disorder of the nervous system. It is     associated with painful muscle spasms and rigidity involving muscles of the limbs, trunk, and     neck. The cause of the disease is unknown, but researchers believe it may be a result of an     autoimmune process. Patients with Stiff-man Syndrome may produce antibodies that attack     enzymes required for the normal function of the nervous system.      Steroids, plasmapheresis, and intravenous immunoglobulin (IVIg) have been given to relieve     some of the symptoms of Stiff-man Syndrome. However, none of these therapies have proven to     be significantly effective.      This study will attempt to determine the effectiveness of intravenous immunoglobulin (IVIg)     for the treatment of Stiff-mann Syndrome. Patients participating in this study will be     divided into two groups. Group one will receive 2 injections of IVIg once a month for three     months. Group two will receive 2 injections of placebo inactive sterile water once a month     for three months. Following the three months of treatment, group one will begin taking the     placebo and group two will begin taking IVIg for an additional 3 months. The drug will be     considered effective if patients receiving it experience a significant improvement in muscle     function, mobility, and stiffness.   "
161947|NCT00001568|"     Positron Emission Tomography (PET scanning) is performed using a total dose of less than 50     mRad per patient visit. Fludeoxyglucose F 18 (FDG) is injected intravenously over 2 min.     Initial dynamic images will be obtained over the heart. Emission imaging will work from the     midcervical region down to the perineal region.      For CEA scanning, radiolabeled antibody, arcitumomab (IMMU-4), is injected intravenously over     5 min. A single photon emission computed tomography (SPECT) transmission scan is performed     over the same regions as the emission scans. Total dose from transmission scans should be no     more than 20 mRad per patient visit.      Patients then undergo exploratory laparotomy performed by two surgeons, one blinded to the     results of the CEA-Scan and PET scan.      At the completion of all exploration, all identified disease is biopsied for pathologic     analysis and any resectable disease is removed.      Patients are followed every 3 months for 1 year, every 6 months for the second year, and then     after 3 years.   "
161937|NCT00001552|"     The purpose the study is to determine the genetic causes of specific voice disorders that run     in families. Researchers are particularly interested in two conditions;        1. Spasmodic dysphonia        2. Vocal fold paralysis      Familial vocal fold paralysis can be a life-threatening disorder that can cause difficulty     with vocal fold movement for breathing and voice and sometimes for swallowing. Studies are     ongoing at the NIH to better understand the pathophysiology and to relate it to the genetic     pattern of inheritance. Families are being recruited to participate in these studies and are     being provided with further information on the disorder and genetic counseling if desired.     Physician referral is requested for affected members of families with vocal fold paralysis of     an unknown cause occurring over at least 2 generations. All travel, lodging, examination and     counseling costs are covered for both affected and unaffected members of a family.     Examinations include: voice, laryngeal, neurological, electrodiagnostic testing, genetic     counseling, and radiological studies....   "
161938|NCT00001553|"     Researchers have been interested in the changes associated with motor function in humans     after suffering a stroke. Presently, the mechanism by which a person recovers motor function     following a stroke is poorly understood. There is little information available about the     areas of the brain involved in the recovery of limb function.      Recently, a new set of techniques have been developed that may be useful for reducing the     physical impairment often associated with strokes.      The best way to identify the areas of the brain associated with regaining function is to test     patients before, during, and after function is regained.      This study will compare two therapies and determine which is better at improving recovery of     motor function. The first technique involves immobilizing the functional limb and actively     training the affected dysfunctional limb. The second technique involves no immobilization,     and passive movement of the affected limb.      Results from this study will indicate which of the two therapies is better at improving motor     function. Additional diagnostic tests will help to identify changes in brain function     associated with recovered use of affected limbs.   "
161939|NCT00001554|"     It is extremely important to identify and distinguish healthy brain tissue from diseased     brain tissue during neurosurgery. If normal tissue is damaged during neurosurgery it can     result in long term neurological problems for the patient.      The brain tissue as it appears prior to the operation on CT scan and MRI is occasionally very     different from how it appears during the actual operation. Therefore, it is necessary to     develop diagnostic procedures that can be used during the operation      Presently, the techniques used for intraoperative mapping of the brain are not reliable in     all cases in which they are used. Researchers in this study have developed a new approach     that may allow diseased brain tissue to be located during an operation with little risk. This     new approach uses nfrared technology to locate the diseased tissue and identify healthy brain     tissue.      The goal of this study is to investigate the clinical use of intraoperative infrared (IR)     neuroimaging to locate diseased tissue and distinguish it from normal functioning tissue     during the operation.   "
161940|NCT00001560|"     This protocol presents the rationale, 25-year historical review, and methods for     multidisciplinary, low-risk studies of individuals referred to the NCI Viral Epidemiology     Branch (VEB). Referrals are generally for unusual types of cancer or related conditions,     known, or suspected to be related to viruses. Kaposi's sarcoma in two homosexual men     evaluated in 1981 is a classic example. These referral cases provide the basis for pilot     studies that generate hypotheses, the development of protocols for formal investigations of     promising leads, and help to set priorities for VEB.      A VEB investigator who is a Staff Member at the NIH Clinical Center, interviews each subject,     performs a physical examination, draws a blood sample, and, when appropriate for the disease     or virus under study, obtains other clinically indicated biological specimens, such as urine,     sputum, saliva, tears, semen, Pap smear, or cervical, anal, oral, or nasal swabs. On     occasion, other relatively non-invasive studies may be indicated. Skin testing with     conventional, licensed antigens for assessment of cellular immunity may be performed, and     skin lesions may be biopsied or excised. Tumor or other tissue biopsies may be obtained when     biopsy or surgery is clinically indicated for other reasons. Otherwise no surgery is     performed, and no therapy is administered. Clinical referral to other components of NCI, NIH,     or the private sector are made as needed. The biological specimens are frozen or otherwise     preserved to be batch tested in current assays or future assays that will be developed. Such     laboratory testing is performed either at VEB's own support laboratory, or collaboratively in     other NCI, NIH, or extramural laboratories that have the needed expertise for the disease or     virus under study.      Occasionally, repeated or more long-term evaluation is required. More often, a single     evaluation in the NIH outpatient clinic, or either at a collaborating physician's office or     other suitable site in the field, is sufficient. The VEB investigator provides counseling     relevant to the virus or disease under study, and about the interim study results. He or she     makes appropriate referral if needed (e.g., to the Genetic Epidemiology Branch for genetic     counseling). Clinically relevant results and the VEB investigator's interpretation of these     results, are provided in writing to the subject's primary caregiver. Confidentially of the     information that is obtained is carefully protected. The results of the study are summarized     for publication in the peer review literature.   "
161957|NCT00001579|"     This is a dose escalation study.      During the first period of this study, an initial pharmacological assessment of fluorouracil     administered intravenously along with oral leucovorin calcium is made. Leucovorin calcium is     given orally bid on days 1-3. Fluorouracil is given as a 24 hour infusion on day 2.      After a 2 week rest period and resolution of any toxicities experienced during the first     period of treatment, patients are given an escalating dose of fluorouracil with fixed doses     of leucovorin calcium and ethynyluracil. Ethynyluracil and leucovorin calcium are given bid     orally on days 1-3 of each week. Fluorouracil is given bid orally on day 2 of each week.     Treatment is repeated for three weeks followed by a one week rest period.      3 to 6 patients are enrolled at each dose level. Dose escalation proceeds until the maximum     tolerated dose (MTD) is determined. MTD is defined as the dose preceding that at which 2 or     more patients experience dose limiting toxicity.   "
162172|NCT00002042|"     To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or     advanced AIDS related complex (ARC) and anemia secondary to their disease.   "
161997|NCT00000988|"     To evaluate the safety, minimum effective dose (MED), pharmacokinetics and efficacy of orally     administered 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) in patients with AIDS or AIDS     related complex (ARC). To establish an appropriate dosage regimen of d4T to be employed in     Phase II and III trials. To evaluate the effects of de-escalating doses of d4T on markers     associated with HIV infection.      Currently, the only FDA-approved therapy for patients with AIDS or ARC is zidovudine (AZT), a     drug with significant value but limited use because of toxic effects on the bone marrow. d4T     has not been tested in humans, but it has inhibited the reproduction of HIV (the virus that     causes AIDS) in laboratory experiments. In some studies with laboratory animals, d4T was less     toxic against blood cells than AZT.   "
162324|NCT00002194|"     To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin,     and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.   "
161941|NCT00001561|"     Both patients and marrow donors are treated on Regimen A; patients then proceed to Regimen B.     The following acronyms are used:      ABM Allogeneic Bone Marrow      BU Busulfan, NSC-750      CF Leucovorin calcium, NSC-3590      CTX Cyclophosphamide, NSC-26271      G-CSF Granulocyte Colony-Stimulating Factor (source not specified)      GM-CSF Granulocyte-Macrophage Colony-Stimulating Factor (Hoechst/Immunex), NSC-613795      GVHD Graft-vs.-Host Disease      Mesna Mercaptoethane sulfonate, NSC-113891      MTX Methotrexate, NSC-740      PP Unconjugated Myeloma Immunoglobulin plasma paraprotein, NSC-684150      PP-KLH Myeloma immunoglobulin plasma paraprotein vaccine, NSC-678327, with keyhole limpet     hemocyanin      TBI Total-Body Irradiation      TSPA Thiotepa, NSC-6396      Regimen A (Donor and Patient): Vaccine Therapy with Immunoadjuvant. PP-KLH (individual     myeloma immunoglobulin plasma paraprotein vaccine prepared from recipient's plasma     paraprotein and conjugated with KLH); and PP; with GM-CSF.      Regimen B (Patient): Myeloablative Radiotherapy and 2-Drug Combination Chemotherapy or 2-Drug     Combination Myeloablative Chemotherapy followed by Hematopoietic Rescue with Growth Factor     Support and GVHD Prophylaxis followed by Vaccine Therapy with Immunoadjuvant. TBI; and     CTX/TSPA; or BU/CTX; followed by ABM; with G-CSF; and CYSP; MTX/CF; followed by PP-KLH; with     GM-CSF.   "
161942|NCT00001563|"     The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed     setting. There is no standard treatment, and the few small studies that have been conducted     have reported dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus     rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study     include toxicity and response. Progression-free and overall survival will be measured. Tumors     will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and     EBV when possible.   "
161943|NCT00001564|"     Arm A:      Peripheral blood apheresis by harvesting chemotherapy-naive T cells and populations enriched     for professional APCs.      T cells and APCs are separated from the apheresis product using countercurrent centrifugal     elutriation and a monocyte rich fraction is collected.      Autologous T cell transplantation during immunotherapy.      Arm B:      Cell harvesting is performed as soon as possible.      Both Arm A and B:      Patients receive intravenous infusion of irradiated peptide-pulsed antigen presenting cell     vaccination (APC) products as well as intramuscular injection of influenza vaccine on the     same day.      Recombinant human IL-2 is administered within 4 hours of the peptide pulsed vaccine by     continuous intravenous infusion for 4 days per week for 3 successive weeks.      Primary toxic effect of this therapy is expected to be related to the IL-2 therapy. Patients     with Grade 2 neurologic or cardiac or any Grade 3 or 4 toxic effects will discontinued IL-2     therapy. If toxic effect is not resolved in 72-hours, the patient may remain on study but     will not receive any further IL-2.   "
161944|NCT00001565|"     This is a pharmacokinetic trial. Patients receive phenylbutyrate through a central venous     catheter for each 28 day cycle. The first several days of drug administration should be     inpatient. Cycles may be repeated if there is no tumor progression or dose limiting     toxicities (DLT). There are no breaks between cycles.      Once a minimum of 3 patients have completed at least 4 weeks of therapy without DLT, new     patients will be entered at the next dose level.   "
161945|NCT00001566|"     This is a single arm study.      The tumor specimen is analyzed for the presence of a fusion protein which corresponds to     available peptides. Patients undergo T cell harvest 10 days after an initial priming     peptide-pulsed antigen presenting cell (APC) vaccine is performed.      Fresh APCs are utilized for initial priming vaccination. All subsequent vaccinations will use     cryopreserved APCs. Minimum number of APCs administered per vaccination is 100,000/kg and     maximum is 100,000,000/kg.      Patients undergo cytoreductive therapy for the treatment of their particular malignancy. This     therapy usually consists of multiagent chemotherapy in the context of a separate protocol.      Following chemotherapy, infusion of harvested T cells followed by infusion of peptide-pulsed     APC vaccinations occurs every 6 weeks for a total of 3 post-priming vaccinations. Influenza     vaccine is administered by intramuscular injection concurrent to peptide-pulsed APC vaccines.      Interleukin -2 (IL-2) is administered as a continuous intravenous (IV) infusion for 4     days/week for 3 successive weeks starting on the same day as T cell /peptide-pulsed     infusions.   "
161946|NCT00001567|"     This study began as an efficacy study of interferon alpha-2a in patients with hairy cell     leukemia. It was observed that most patients responded with interferon, but that very few     complete responses were being obtained. Studies being done elsewhere confirmed the low     complete remission rate. Once interferon was stopped, nearly uniformly disease progression     requiring reinstitution of therapy was observed. There appear to be very few if any patients     who will not require further therapy after receiving 12 or 18 months of continuous interferon     treatment. Because of these findings, and in order to evaluate the safety and efficacy of     long-term recombinant interferon-alpha (IFN-Alpha) in patients with hairy cell leukemia, we     opted to administer interferon continuously to patients who were initially responsive to this     drug. Of the 53 evaluable patients (of the 56 entered on this study), there was one complete     remission, 41 partial remissions, 1 minor response, 9 patients with stable disease and only 1     patient with disease progression. Fourteen patients continue to receive interferon without     interruption with a median duration of continuous interferon treatment of 9.2 years.     Thirty-four patients discontinued interferon for a variety of reasons, the most common being     the development of acquired interferon resistance in association with interferon antibodies.     The resistance to interferon was manifested early, in the first 18 months of treatment,     except in two cases. An important finding in this study is the continued slow, but     significant, hematologic improvement in absolute granulocyte and platelet counts beyond 18     months of therapy, thereby indicating that prolonged treatment results in continued benefit     rather than the production of antibodies with subsequent development of interferon     resistance. Although it is clear from this study that hairy cell leukemia can be controlled     in the long-term with interferon, longer follow-up will be necessary to determine if     continuous therapy with interferon is better than intermittent therapy. The optimal therapy     for hairy cell leukemia remains open to discussion. Although early reports suggested that     2-chlorodeoxyadenosine was curative, additional studies with longer periods of follow up     suggests that as many as 30% of patients will relapse. This study provides the only instance     where continuous long term treatment with interferon has been evaluated. This provides an     opportunity to evaluate the long term toxicity of chronic interferon therapy, the long term     efficacy of this treatment and to evaluate the potential benefits of long term interferon in     preventing second malignancies, a complication noted in about 15% of patients treated in     other fashions.      After their initial clinical evaluation, patients were given 3 million units of recombinant     IFN-Alpha subcutaneously daily for 4 to 6 months. In responding patients, maintenance therapy     was given at a dose of three million units subcutaneously 3 times per week. Responding     patients have continued on therapy indefinitely.   "
161958|NCT00001580|"     Acquisition of fresh tumor and normal tissue samples are necessary for the preparation of     cDNA libraries, microarray chips, and tissue specific probes, and proteomics development and     validation. This protocol will allow acquisition of samples at the time of tissue sampling     for surgery, diagnostic tests, or therapeutic phereses. These samples will be forwarded     without patient identifiers, pathology reports, or other labels. Tissue pathology will be     verified within the Laboratory of Pathology and samples used strictly for CGAP and Proteomic     Initiative indications.   "
162405|NCT00002251|"     This study is designed to determine the influence of food on the absorption and relative     bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed     and fasting state at steady state plasma levels.   "
161948|NCT00001569|"     Two days prior to planned surgery, paclitaxel is infused IV over 24 hours.      Patients will undergo cytoreductive surgery, to debulk tumor. Scope of procedure will vary     with each patient, including a spectrum of possible procedures, such as splenectomy, liver     resection, pancreatic resection or bowel resection.      After cytoreductive surgery, continuous hyperthermic peritoneal perfusion (CHPP) surgery with     cisplatin will begin by placing an influx and efflux catheters via abdominal wall. Perfusion     rate of cisplatin is 1.5 L/min and the duration is 90 min.      Postoperative intraperitoneal chemotherapy will begin 24 hours after CHPP surgery.      Dose escalation will proceed after patients at a given dose level receive 3 courses. In order     to properly evaluate hematoxicity, a minimum of 3 weeks will be required before dose     escalation. MTD is either the dose level immediately below the level at which 2 of 6 patients     in a cohort experience nonhematologic dose limiting toxicity (DLT) or when 4 of 6 patients     experience hematologic DLT.      Two to 4 months after surgery, laparotomy will be conducted to determine response to     treatment. If tumor size is decreased, patients will undergo a second treatment course     identical to the same techniques and chemotherapy agents.   "
161949|NCT00001570|"     Bolus PSC 833 is administered on Day 1 simultaneously with initiation of 24 hour continuous     infusion of PSC 833, followed by another continuous infusion lasting an additional 6 days. To     ensure the safety of a 7 day infusion of PSC 833, one patient is treated for 5 days and a     second for 6 days, before the first cohort is enrolled.      Vinblastine is administered in escalating doses on days 2-5. At least 3 patients are entered     at each dose level. The MTD will be defined as the dose immediately below that at which 2     patients experience dose limiting toxicity.      Treatment continues every 28 days.   "
161950|NCT00001571|"     Non-Hodgkin's lymphoma (NHL) is the third most rapidly increasing cancer in the United     States. HIV-related NHL is responsible for some of the increase since the early 1980s.     However, it cannot explain the steady increase in the incidence rates in earlier years, nor     the entire increase shown recently. A possible role of environmental exposures is receiving     attention. One possibility is that exposure to organochlorines (OCs) may be related to the     occurrence of NHL. NCI is currently designing a large population-based case-control study to     investigate this hypothesis further by analyzing OC levels in blood collected at the time of     interview from cases of NHL and their matched controls. At the time of these interviews,     cases in the main case-control study would most likely have already received chemotherapy. If     chemotherapy changes the blood levels of OCs, this may lead to misclassification of exposure     among cases and eventually to biased risk estimates. The purpose of this pilot study is to     estimate the bias due to measuring the serum levels of OCs in cases during or after     chemotherapy. Twenty newly diagnosed patients will be recruited for the study. From each     patient, four consecutive blood samples, one prior to, two during, and one after     chemotherapy, will be collected. Forty pairs of pre-existing cryopreserved serum samples     (pre- and post-treatment) taken from the NHL patients who participated in an earlier NCI     clinical study will also be included in this study. Samples will be assayed for OC levels.     The results will be used to plan and to interpret another large case-control study (the main     study).   "
161951|NCT00001572|"     Patients undergo chemotherapy until remission is obtained, or disease has been stable for two     cycles of chemotherapy, or progressive disease develops.      Three to six months after completion of chemotherapy, patients who have achieved complete     clinical remission or minimal disease status receive a series of 5 injections (given 1-2     months apart) of a vaccine consisting of 0.5 mg autologous tumor-derived immunoglobulin (Id)     conjugated to KLH. The vaccine is administered with subcutaneous QS-21 as an immunological     adjuvant....   "
161952|NCT00001573|"     A dose escalation scale consisting of 5 dosage levels is being used to determine the maximum     tolerated dose (MTD) of SU101. A minimum of 3 and a maximum of 6 patients will be enrolled at     each dose level. MTD is defined as the dose level immediately below that at which 2 or more     patients exhibit dose limiting toxicity.      Each treatment cycle is 21 days. Patients receive a 96 hour continuous IV infusion of SU101     on days 1-4.   "
161953|NCT00001574|"     Brain tumors represent the most common solid tumor of childhood. Treatment generally entails     surgery and radiation, but local recurrence is frequent. Chemotherapy is often used in an     adjuvant setting, to delay radiation therapy or for resistant disease. Children with brain     tumors are generally followed by imaging studies, such as CT or MRI. Difficulty arises in     trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation     injury. Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive     method of detecting and measuring cellular metabolites in vivo. NMRS imaging complements     routine MRI by giving chemical information in conjunction with spatial information obtained     by MRI.      This study will be conducted to determine NMRS imaging patterns before, during and after     chemotherapy in pediatric patients with primary or metastatic brain tumors in an attempt to     identify and characterize specific patterns of metabolites related to tumor regrowth, tumor     response to therapy, edema or necrosis.   "
161954|NCT00001575|"     This study will examine the use of a radioactive monoclonal antibody called yttrium     90-labeled humanized anti-Tac (90 Y-HAT) for treating certain cancers. Monoclonal antibodies     are genetically engineered proteins made in large quantities and directed against a specific     target in the body. The anti-Tac antibody in this study is targeted to tumor cells and is     tagged (labeled) with a radioactive substance called Yttrium-90 (Y-90). The study will     determine the maximum tolerated dose of 90Y-HAT and examine its safety and effectiveness.      Patients 18 years of age and older with Hodgkin's disease, non-Hodgkin's lymphoma and     lymphoid leukemia who have proteins on their cancer cells that react with anti-Tac may be     eligible for this study. Candidates are screened with a medical history and physical     examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, computed tomography     (CT) scan or ultrasound of the abdomen, positron emission tomography (PET) scan of the neck     and body, and skin test for immune reactivity to antigens (similar to skin tuberculin test).      Before beginning treatment, participants may undergo additional procedures, including the     following:        -  Patients with suspicious skin lesions have a skin biopsy. An area of skin is numbed and          a circular piece of skin about 1/4-inch diameter is removed with a cookie cutter-like          instrument.        -  Patients with hearing loss have a hearing test.        -  Patients with neurological symptoms have a lumbar puncture (spinal tap). A local          anesthetic is given and a needle is inserted in the space between the bones in the lower          back where the cerebrospinal fluid circulates below the spinal cord. A small amount of          fluid is collected through the needle.        -  Patients who have not had a bone marrow biopsy within 6 months of screening also undergo          this procedure. The skin and bone at the back of the hip are numbed with a local          anesthetic and a small piece of bone is withdrawn through a needle.      Patients receive 90 Y-HAT in escalating doses to determine the highest dose that can be     safely given. The first group of three patients receives a low dose and, if there are no     significant side effects at that dose, the next three patients receive a higher dose. This     continues with subsequent groups until the maximum study dose is reached. 90 Y-HAT is given     through a vein (intravenous (IV)) over a 2-hour period. In addition, a drug called Pentetate     Calcium Trisodium Inj (Ca-DTPA) is given via IV over 5 hours for 3 days to help reduce the     side effects of the 90Y-HAT. In some patients, the 90 Y-HAT may also be attached to a     radioactive metal called Indium-111 to monitor what happens to the injected material. During     infusion of the drug, patients undergo PET scanning to trace the path of the injected     material in the body. For this procedure, the patient lies in the scanner, remaining in one     position during the entire infusion.      Blood and urine specimens are collected periodically over a 6-week period following the     infusion to determine the level of the radioactive antibody. Bone marrow, lymph node, or skin     biopsies may be done to determine how much of the antibody entered these sites. Patients     whose disease remains stable or improves with therapy may receive up to six more infusions of     90 Y-HAT, with at least a 6-week interval between treatments.   "
161955|NCT00001576|"     Patients with unresectable metastatic colorectal cancer confined to the liver will undergo a     1 hour hyperthermic isolated hepatic perfusion (IHP) with escalating dose melphalan.     Postoperatively, patients will be treated with hepatic arterial infusion of floxuridine     (FUDR), 0.2 mg/kg/day and leucovorin (LV), 15 mg/M2/day as a 2-week continuous infusion     regimen. Hepatic and systemic toxicity, response to treatment, duration of response, and     survival will be followed.   "
161956|NCT00001577|"     Hyperthermic isolated limb perfusion with melphalan alone is administered as a double     perfusion schedule.      These two isolates limb perfusions with melphalan are treated 3-6 weeks apart. After     perfusion is established, the leak rate has been determined to be acceptable, and tissue     temperatures are 38 degrees Celsius, then the melphalan is administered by slow injection     into an arterial line over approximately 5 minutes. The perfusion with melphalan will then     continue for 60 minutes, after which the extremity is flushed out with a total of 3 liters of     fluid consisting initially of a saline solution. The dose of melphalan for the second     perfusion will be increased.      An attempt to resect the residual lesion between 6-12 weeks after the second      interval perfusion may be made.   "
162173|NCT00002043|"     To determine which of 2 doses of dapsone is effective prophylaxis for Pneumocystis carinii     pneumonia (PCP) in patients with oral thrush or hairy leukoplakia and less than 400 CD4     lymphocytes per mm3. To determine whether the long-term toxicities associated with daily     dapsone in this population are tolerable.   "
161959|NCT00001582|"     This protocol is being submitted to consolidate, update, and expand two previously approved     protocols (77-C-0066 and 82-C-0044) into a single protocol. The purpose of this study is to     examine the factors involved in the regulation of the immune system of healthy individuals     and to define the abnormalities in this regulation that underlies the immunological disorders     of patients with a variety of immunodeficiency and malignant disorders. The studies will     include the ex vivo phenotypic and functional analysis of the network of cells involved in     humoral and cellular immune responses, and in vivo testing for the capacity to make     delayed-type hypersensitivity and humoral responses following immunization with a variety of     antigens. Individuals to be studied will include patients with a variety of malignancies and     patients with primary and secondary immunodeficiency disorders. Selected family members or     family members known to be genetic carriers of certain immunodeficiency diseases as well as     normal, unrelated individuals will also be studied. A small number of procedures will be used     including analysis of blood obtained by phlebotomy, apheresis, skin testing and recall     antigens and immunization to assess humoral immunity.   "
161960|NCT00001584|"     Virus present in semen likely contributes substantially to the sexual transmission of HIV.     However, the source of HIV in semen is unknown. Some evidence suggests that the prostate may     be the source of at least some of the virus in semen. This study is designed to determine     whether the prostate may serve as the source of virus in semen by comparing the concentration     of HIV-1 RNA in semen donated normally, in semen obtained following prostatic massage, and in     expressed prostatic secretions. Finding a source for semen HIV would provide important     insights into several aspects of HIV sexual transmission. Since some drugs do not enter the     prostate well, the finding that virus is produced in the prostate might suggest the prostate     could serve as a reservoir for HIV, leading to the development of resistance to antiviral     agents.   "
161961|NCT00001586|"     Background:        -  Combined therapy with rituximab and fludarabine is the treatment of choice for advanced          stage chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).        -  A new technology called deoxyribonucleic acid (DNA) microarray can be used to gain          knowledge about the genetic basis of CLL/SLL.        -  Genetic studies of CLL/SLL may improve our understanding of what happens in the disease,          help determine which patients are most likely to respond to treatment with fludarabine          and rituximab, and identify new treatments.      Objectives:      -To gain further knowledge about CLL/SLL and the role of rituximab and fludarabine in     treating the disease.      Eligibility:      -Patients 18 years of age and older with low, intermediate or high-risk CLL/SLL.      Design:        -  Patients with low-risk CLL/SLL do not receive treatment, but are followed every 3 to 6          months and donate cells (through apheresis) or lymph nodes, or both, for research          purposes.        -  Patients with intermediate or high-risk CLL/SLL receive standard treatment with          rituximab and fludarabine for six 28-day treatment cycles. Rituximab is given on day 1          and fludarabine is given on days 1-5. (For the first cycle only, fludarabine treatment          starts on day 2. This delay permits blood sampling on day 1 for the effect of rituximab          on white blood cells.)        -  Laboratory tests and imaging studies are done periodically to monitor drug side effects          and the response to treatment. Tests include bone marrow biopsy and aspiration, blood          tests and x-rays, including positron emission tomography (PET) and computed tomography          (CT) scans.   "
161962|NCT00001587|"     Patients with unresectable primary or metastatic cancer confined to the liver will undergo a     1 hour hyperthermic isolated hepatic perfusion (IHP) via the portal vein and hepatic artery     with escalating dose melphalan. Patients eligible for this protocol are those with     non-colorectal histologies and those with colorectal cancer previously treated with     intra-arterial FUDR. Hepatic and systemic toxicity, response to treatment, duration of     response, and survival will be followed.   "
161963|NCT00001589|"     Iron has been proposed to contribute to atherogenesis in humans by facilitating the oxidation     of lipoproteins. This observational study will evaluate the association between frequency of     blood donation - expected to be associated with relatively reduced body iron stores in     frequent donors - and carotid atherosclerosis. The primary outcome variable will be whether     the presence and extent of asymptomatic carotid atherosclerosis as measured by ultrasound is     greater in infrequent (less than or equal to 1 donations/year greater than or equal to 5     years) vs. frequent (greater than or equal to 4 donations/year greater than or equal to 5     years) blood donors. Body iron stores, lipid and hemostatic parameters, nitric oxide     formation, inflammatory parameters, and markers of vascular oxidative stress will be analyzed     as secondary outcome measures. Laboratory analysis and ultrasound testing will be performed     blinded to the patient's phlebotomy and iron status. Sixty frequent (n=40 males greater than     40 y/o, n=20 females greater than 50 y/o) and 60 infrequent (n=40 males greater than 40 y/o,     n=20 females greater than 50 y/o) blood donors will be recruited for this study from the     Department of Transfusion Medicine, W. G. Magnuson Clinical Center. All donors will be     assessed for study eligibility and cardiovascular risks during the screening visit. The     presence of atherosclerotic lesions by carotid ultrasound and secondary outcome parameters     will be assessed during a second visit.   "
161964|NCT00001591|"     Technical advances in magnetic resonance imaging (MRI) and magnetic resonance spectroscopy     (MRS) have provided researchers with the opportunity to study changes of the central nervous     system (CNS) and improve diagnosis and therapy of CNS disease. New MRI and MRS techniques     specifically designed for functional MRI (fMRI) and MRS imaging of the CNS will be evaluated     in normal volunteers and in patients with CNS diseases. This study will develop and evaluate     new magnetic resonance pulse sequences for performing MRI or MRS and compare the results to     existing MR techniques.      Patients and volunteers age 18 and older are eligible for the study. A history will be taken     in which exclusion criteria (such as having a pacemaker or cochlear implants) will be     addressed, and a pregnancy test will be administered to women of childbearing age. Each     subject will also be asked to fill out a questionnaire.      Study participants will lie in the MRI scanner from 20 minutes to 2 hours. A coil may be     placed on the head and participants may be asked to do simple or complex tasks. A catheter     will be placed in an arm vein and a contrast agent will be administered. This agent will     allow structures in the brain to show up more clearly.   "
162215|NCT00002085|"     To evaluate the efficacy and safety of azithromycin given chronically for the treatment of     serious nontuberculous mycobacterial infection in patients failing or intolerant of other     available therapy.   "
161965|NCT00001594|"     We propose a longitudinal study of the natural history of types III and IV osteogenesis     imperfecta for children age birth to 25 years. A consistent objective throughout this study     is to obtain a comprehensive assessment of the natural history and progression of the     multiple secondary features of osteogenesis imperfecta. In addition to radiographic, bone     density, physical rehabilitation and dental manifestations, we will assess the     cardiovascular, pulmonary, neurological, and audiology systems.      The major objectives of this protocol focus on rehabilitation and physical therapy studies,     pulmonary and cardiovascular function, neurological features, audiological studies and     genetic and molecular biology aspects of OI. A major objective in this study is to expand the     intensive rehabilitation and physical therapy studies of children with types III and IV OI.     This objective continues the work that has been done in the Rehabilitation Department of the     Clinical Center for the past 20 years on these patients. However, the focus of this objective     is changing to include studies of scoliosis and its effect on function, studies of chest     proportions and rib deformities, and studies of nonkinetic variables related to motor     performance, such as temperament, competence, coping, and resilience in children with OI. The     second major objective is the longitudinal study of pulmonary function in children with types     III and IV OI. It is well known that cardiopulmonary complications are a major cause of     disability and death in adults with OI; the developmental patterns of these complications,     and whether susceptible individuals can be identified in childhood, is unknown. The third     major objective of these studies of secondary features is to determine the incidence of     basilar invagination and develop a monitoring and management plan for this neurological     feature. Next, the prevalence, severity, age of onset and genotypic/phenotypic correlation of     hearing loss among children with types II and IV OI remains poorly understood; therefore, the     study of audiological features is our fourth major objective. The final major objective in     this study is the continued study of the genetic and molecular biology aspect of OI. Patients     will have skin biopsies for collagen studies at the biochemical and molecular level. Parents     will have blood drawn for determination of mosaic status for the mutation that causes their     child s OI. These studies will provide further information on genotype/phenotype correlation     and other variables in OI genetics. As appropriate, bone chips from emergency or elective     surgical procedures on the participants will be used to study osteoblast function in OI.   "
161966|NCT00001595|"     There is a variety of tumors affecting the pituitary gland in childhood; some of these tumors     (eg craniopharyngioma) are included among the most common central nervous system tumors in     childhood. The gene(s) involved in the pathogenesis of these tumors are largely not known;     their possible association with other developmental defects or inheritance pattern(s) has not     been investigated. The present study serves as a (i) screening/training, and, (ii) a research     protocol.      As a screening and training study, this protocol allows our Institute to admit children with     tumors of the hypothalamic-pituitary unit to the pediatric endocrine clinics and wards of the     NIH Clinical Center for the purposes of      (i)<TAB>training our fellows and students in the identification of genetic defects associated     with pituitary tumor formation, and      (ii)<TAB>teaching our fellows and students the recognition, management and complications of     pituitary tumors      As a research study, this protocol aims at      (i)<TAB>developing new clinical studies for the recognition and therapy of pituitary tumors;     as an example, two new studies have emerged within the context of this protocol: (a)     investigation of a new research magnetic resonance imaging (MRI) tool and its usefulness in     the identification of pituitary tumors, and (b) investigation of the psychological effects of     cortisol secretion in pediatric patients with Cushing disease. Continuation of this protocol     will eventually lead to new, separate protocols that will address all aspects of diagnosis of     pituitary tumors and their therapy in childhood.      (ii)<TAB>Identifying the genetic components of pituitary oncogenesis; those will be     investigated by (a) studying the inheritance pattern of pituitary tumors in childhood and     their possible association with other conditions in the families of the patients, and (ii)     collecting tumor tissues and examining their molecular genetics. As with the clinical     studies, the present protocol may help generate ideas for future studies on the treatment and     clinical follow up of pediatric patients with tumors of the pituitary gland and, thus, lead     to the development of better therapeutic regimens for these neoplasms.   "
161967|NCT00001596|"     Hermansky-Pudlak Syndrome (HPS) is an inherited disease that results in decreased     pigmentation (oculocutaneous albinism), bleeding problems due to a platelet abnormality     (platelet storage pool defect), and storage of an abnormal fat-protein compound (lysosomal     accumulation of ceroid lipofuscin).      The disease can cause poor functioning of the lungs, intestine, kidneys, or heart. The most     serious complication of the disease is pulmonary fibrosis and typically causes death in     patients 40 - 50 years old. The disorder is common in Puerto Rico, where many of the clinical     research studies on the disease have been conducted. Neither the full extent of the disease     nor the basic cause of the disease is known. There is no known treatment for HPS.      The drug pirfenidone blocks the biochemical process of inflammation and has been reported to     slow or reverse pulmonary fibrosis in animal systems.      In this study researchers will select up to 40 HPS patients diagnosed with pulmonary     fibrosis. The patients will be randomly divided into 2 groups. The patients will not know if     they are taking pirfenidone or a placebo sugar pill.        1. Group one will be patients who will receive pirfenidone.        2. Group two will be patients who will receive a placebo sugar pill      The major outcome measurement of the therapy will be a change in the lung function (forced     vital capacity). The study will be stopped if one therapy proves to be more effective than     the other.   "
161968|NCT00001597|"     This study will attempt to develop and validate improved subjective measures of pain     sensation and use these measures to evaluate pain sensitivity in patients.      Normal healthy volunteers and dental patients undergoing third molar extraction may be     eligible for this study. Participants will undergo the following procedures:      Volunteers: Volunteers will participate in two 90-minute sessions in which they will receive     and rate four heat stimuli per minute applied to the skin for a maximum of 36 minutes. The     heat stimuli range from 37° (Degree)C to 51° (Degree)C (99° (Degree) F to 124° (Degree) F)     and last 2 to 3 seconds. A drug commonly used in dental treatments may be administered during     the second session. This will be either a maximum of 0.15 mg fentanyl, a short-acting     narcotic pain killer, or a maximum of 5 mg saline, an inactive substance (placebo).      Dental patients: Dental patients will participate in two 60-minute sessions. The first     session will be on the day before the third molar extraction, and the second session will be     immediately before the dental procedure. The heat stimulus procedure will be identical to     that described above for normal healthy volunteers.   "
161969|NCT00001598|"     This study will evaluate the effectiveness of the male hormone dehydroepiandrosterone (DHEA)     in treating Sjogren's syndrome. This autoimmune disorder, in which the immune system attacks     the salivary glands and tear glands, affects primarily women. Patients' eyes and mouth become     drier over time, and can lead to problems such as serious tooth decay and eye irritations.     Sex hormones seem to influence the immune response and may help decrease disease severity.     DHEA has benefited some patients with two other autoimmune diseases, rheumatoid arthritis and     systemic lupus erythematosus.      Women 18 to 75 years of age with Sjogren's syndrome may be eligible for this 7-month study.     At the initial visit, candidates will have a physical examination, routine blood and urine     tests and eye and dental examinations, including a test to measure saliva production for     screening purposes and to establish baseline values for participants.      Those enrolled in the study will be randomly assigned to take either DHEA or placebo     (look-alike tablet with no active ingredient) once a day for 6 months and will be monitored     with follow-up visits at months 1, 3, 6 and 7. Physical examination, blood tests and     urinalysis will be repeated at months 1, 3, 6 and 7; saliva will be collected at months 3, 6     and 7; and eyes will be examined at 3 and 6 months. Because hormone changes may have both     physical and emotional effects, patients will be asked questions about their mood, symptoms     and side effects of treatment.      It is not known if Sjogren's syndrome is associated with osteoporosis (bone thinning), but     since this condition occurs in other autoimmune disorders, patient's bone density will be     measured at the first visit, and blood drawn at 3 and 6 months will be tested for various     substances associated with changes in bone density. A 24-hour urine collection at the first     visit and later urine tests will also be tested for substances associated with bone thinning.   "
162109|NCT00001103|"     The purpose of this study is to see whether anti-HIV drugs that reduce HIV in the blood also     reduce HIV in the cerebrospinal fluid (CSF). CSF is the fluid found around the brain and     spinal cord. This study also looks at whether reducing HIV in the CSF can help protect brain     function.      HIV can be detected in the brain and CSF early in HIV disease. Anti-HIV drugs probably reduce     HIV in the CSF. This may be important because other studies have suggested high CSF HIV     levels may lead to some loss of brain function.   "
161970|NCT00001599|"     This study will evaluate the safety and effectiveness of thalidomide in treating Sjogren's     syndrome. In this autoimmune disease, the immune system attacks the body's tear glands and     salivary glands, causing dry mouth and dry eyes. Thalidomide has shown promise in treating     other autoimmune disorders, such as rheumatoid arthritis and systemic lupus erythematosus.      Women with Sjogren's syndrome who have dry eyes and dry mouth may be eligible for this study.     Women of childbearing potential will not be considered for participation because of severe     birth defects associated with thalidomide. Also, since Sjogren's syndrome affects many fewer     men than women, men are excluded from this pilot study because they would be too few in     number to assess as a separate group. Candidates will be screened with a medical history,     physical examination, blood and urine tests, electrocardiogram, chest X-ray and pregnancy     test. Tests will also be done to measure the conduction of electrical impulses along the     nerves and to evaluate dryness of the eyes.      Participants will be randomly assigned to take either thalidomide or a placebo (look-alike     pill with no active ingredient). The thalidomide dosage will be increased gradually from a     starting dose of 50 Mg. up to 300 Mg., depending on side effects. Women of childbearing age     who have had a tubal ligation or longstanding infertility will have a pregnancy test every 2     or 4 weeks.      Participants will come to the clinic at the first study visit and again at weeks 4, 8 and 12     for some or all of the following procedures:        -  Patient assessment of dry mouth (rated on a scale from worst ever to best ever        -  Patient assessment of dry eyes (rated on a scale from worst ever to best ever        -  Patient health questionnaire and disease assessment rating        -  Saliva collection        -  Rose-Bengal or other dye tests for dryness - examination of the eyes under a bright          light following administration of drops containing a dye        -  Schirmer's I test for dryness - placement of a thin rectangular strip of filter paper in          the eye following administration of anesthetic drops        -  Blood tests to measure blood cell counts and levels of various immune substances in the          blood, and to evaluate liver and kidney function        -  Urine tests to evaluate kidney function        -  Nerve conduction tests - measurement of the speed with which nerves conduct electrical          impulses. Two nerves in the arm and one nerve in the leg will be tested.      Participants will also be contacted by telephone every week to report any side effects.   "
161971|NCT00001600|"     This study provides a mechanism for evaluating patients for possible participation in NIDCR     clinical research studies. NIDCR studies involve three major areas-pain, neurosensory     mechanisms, and pain-relieving drugs-all of which have specific requirements and patient     characteristics. No treatment is offered under this protocol; it is intended to facilitate     patient recruitment into NIDCR studies.      Patients with unusual or unknown conditions that have or have not been diagnosed may be     eligible for this screening study. Specific medical criteria for enrollment vary with the     particular protocol for which the individual is being screened. Medical and dental histories     will be obtained and participants will have a dental examination. Diagnostic procedures will     be done in accord with standard medical and dental practice and may include X-rays, blood     tests, and routine urinalysis, as appropriate. Participants found eligible for an active     study may enroll in that study. Those who are not eligible for a current study may be     re-evaluated for future studies within a year if they wish. After 1 year, participants for     whom no appropriate studies are identified will be referred back to their primary doctor or     referring physician or dentist.   "
161972|NCT00001601|"     This study offers evaluation and treatment of patients with diseases of the mouth or systemic     diseases that involve the mouth. The protocol is not designed to test new treatments; rather,     patients will receive current standard of care treatments. The purposes of the study are: 1)     to allow NIDCR's Gene Therapy and Therapeutics Branch staff to gain more knowledge about oral     soft tissue diseases and possibly identify new avenues of research in this area; and 2) to     establish a pool of patients who may be eligible for new studies as they are developed.     (Participants in this protocol will not be required to join a new study; the decision will be     voluntary.)      Patients of any age with oral diseases or systemic diseases involving the mouth may be     eligible for this study. Women of childbearing potential and women who are pregnant or     breastfeeding will only have tests and procedures and receive medications that pose no     greater than a minimal risk to the fetus.      Participants will have a comprehensive dental and medical examination, including a physical     examination of the head and neck. Additional tests and procedures that may be required for     diagnosis and to guide treatment include the following:        -  Blood and urine tests - for routine laboratory studies, assessment of kidney and liver          function, and detection of viruses, fungi, bacteria or parasites        -  Electrocardiogram - to record the electrical activity of the heart        -  Biopsies - to examine tissue under the microscope. The method and number of biopsies          depends on the individual's specific condition and the tissue to be removed. For all          biopsies a local anesthetic (lidocaine with or without epinephrine) is injected at the          biopsy site. A punch biopsy uses a small sharp cookie-cutter instrument to remove a          small (about 1/10- to 1/5-inch) piece of skin. An excisional biopsy uses a small          surgical knife or scalpel to remove a piece of tissue, usually requiring some stitches          to close the wound.        -  Diagnostic imaging - X-rays, photographs, or other tests as needed for diagnosis      Treatments include tablets, injections and topically applied medications. All preparations     are approved by the Food and Drug Administration and are commercially available. Patient     follow-up may vary from one visit to intermittent visits over a number of years, depending on     the patient's condition.   "
161973|NCT00001602|"     Stuttering is an abnormality in speech that affects the rhythm of speech. People who stutter     know what they wish to say, but at the time are unable to say it because of involuntary     repetition, unnecessary lengthening (prolongation), or early stopping (cessation). This study     is designed to increase understanding of the genetic factors that may relate to stuttering.      Deoxyribonucleic acid (DNA) is a protein found in the nucleus of all cells. It is responsible     for carrying the genetic information of the organism. DNA provides the directions for making     all of the substances in the human body. DNA can be linked together in small segments called     genes. Genes can contain information about anything related to an organism.      In order for researchers to determine what genes are directly related to stuttering they must     conduct several types of studies.      Linkage studies, are studies of families that have a lot of members who stutter from several     generations. The linkage studies will be completed using adult individuals who are diagnosed     as persons who stutter and persons who have never stuttered, from one or more families with     large numbers of family members who have stuttered over several generations.      Candidate gene studies, look closely at genes suspected to be related to stuttering in     patients who may or may not have a significant family history of stuttering.      By conducting these studies, researchers hope to learn more about genes related to stuttering     and ultimately find out what causes stuttering.   "
161992|NCT00000983|"     To evaluate and compare differences in tolerance and side effects associated with two     different dosages of zidovudine (AZT) when used to treat children with HIV infection. Other     goals are to evaluate and compare the degree of change in neurodevelopmental disease and     determine whether there are differences in the rate and degree of toxicities associated with     one versus the other dosage.      AZT has been shown to decrease the death rate and frequency of opportunistic infections in     certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic     HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics     (blood levels) in children have indicated that AZT can be given to children in doses that can     be tolerated and that can be assumed to be therapeutic. Those currently taking care of     infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance)     trial. In addition, given the information learned from studies of adult patients that shows     effectiveness of AZT at lower doses, experience with an equivalent lower dose in children     needs to be studied.   "
165739|NCT00005508|"     To define factors contributing to coronary heart disease (CHD) in high risk families.   "
161974|NCT00001603|"     The goal of this study is to learn how tumors of the upper airway and digestive passages     (tongue, throat, mouth, and voicebox) affect the body's immune defenses and energy storage.      Previous studies have shown that tumors of the vocal tract produce signals that could help     the tumor escape the body's immune defenses and use the body's energy and mineral stores to     grow.      Researchers are hoping to learn more about what signals give tumor cells an advantage to live     and grow, how tumor cells control these signals, and how these signals affect the rest of the     body. This study will look closer at researchers belief that tumors in the vocal tract     contain genes (genetic information) that abnormally function to allow the tumors to survive     and grow against the attack of the body's normal immune system      Patients with cancerous tumors (squamous cell carcinoma) and benign (non-cancerous) tumors     (papilloma) of the upper aerodigestive tract who are candidates for standard or     investigational therapy are eligible to participate in this study.      Tumor cells will be collected from patients participating in the study, who will undergo     standard surgical treatment or biopsies for their conditions. Once tumor cells are collected     they can be analyzed for their genetic make-up.      In addition, patients will undergo several tests using skin, blood, and urine to look closely     at the function of their immune systems and metabolism.   "
161975|NCT00001604|"     Stuttering is an abnormality in speech that affects the rhythm of speech. People who stutter     know what they wish to say, but at the time are unable to say it because of involuntary     repetition, unnecessary lengthening (prolongation), or early stopping (cessation). Stuttering     is characterized by repetitions or prolongation of the first syllable, or silent     prolongations, sometimes known as blocks.      Researcher intend on studying the genetic basis for stuttering. The goal of the study is to     find the genes that help cause stuttering and determine regions of the human genetic make-up     (genome) that are linked to stuttering.. To do this researchers will study the patterns of     inheritance in families who have had members who stutter.      The study has two objectives.      The first objective is to develop a large collection of DNA samples from individuals in     stuttering families, that will include both members that stutter and who do not stutter.      The second objective of the study will be to find out the basic combination of genes     (genotype) making up all of the participants DNA. Once this is completed researchers hope to     map out and find areas or regions of DNA that are linked to stuttering.      Genetic linkage is the initial step in positional cloning, and the cloning of genes which     predispose individuals to stuttering is a long term goal of this research study.<TAB>   "
161976|NCT00001605|"     Acute otitis media (OM) and OM with effusion are common childhood diseases. Otitis media is a     condition marked by inflammation of the middle ear. Otitis media with effusion typically     means a long-term (chronic) middle ear inflammation with secretion of fluid into the middle     ear due to the blockage of the canal leading from the middle ear to the mouth (eustachian     tube). The fluid involved can be sterile (no organisms) or infected with disease causing     organisms, such as bacteria or viruses.      Nontypeable Haemophilus influenzae (NTHi) is a bacteria that is one of the leading causes of     OM and respiratory infections in older people. NTHi carry substances on their surface called     antigens. When antigens come into contact with the right kinds of cells in the body, an     immune reaction is caused. This reaction is often the symptoms of sickness that a patient     feels. One of the major antigens on the surface of NTHi is called lipooligosaccharide (LOS).      In order for the body to fight off the attack of antigens, it creates substances called     antibodies. Antibodies counter the action of antigens and make the bacteria harmless.     However, the immune system must learn how to make the right antibodies for the right     antigens. This is done by giving vaccines.      Vaccines can contain a small amount or an inactive form of an antigen. Once the immune system     recognizes the antigen it can start making antibodies to prevent sickness if it is ever     exposed to the antigen again. Presently there are no vaccines for NTHi.      One of the reasons why there is no vaccine for NTHi is because the antigen, LOS, is very     toxic when given to humans. Researchers have tried to make the antigen less dangerous by     removing the toxic effects. It is referred to as dLOS. Unfortunately, dLOS is unable to start     antibody production.      However, researchers have found that by combining dLOS with another vaccine for tetanus     (tetanous toxoid), they were able to stimulate the immune system to create antibodies in     laboratory animals. These laboratory animals were protected against NTHi infections and     otitis media (OM).      Researchers would like to test the effectiveness and safety of dLOS-TT vaccine in adult     humans. Their ultimate goal is to develop a vaccine for OM and respiratory infections caused     by NTHi.   "
161977|NCT00001606|"     This studied is designed to discover the genes that cause hearing impairment. More precisely,     this study aims to map and clone genes that are important for the development and maintenance     of the anatomy and physiology related to hearing (auditory system).      The study will begin by finding large families who have members with hearing impairment. Once     families are found, members with and without hearing impairment will be evaluated by an     audiologist and a clinician (doctor). An audiologist, is a person trained in evaluating,     habilitating, and rehabilitating people with disorders of hearing function. The clinician's     responsibility is to examine the patients and check for other signs and symptoms related to     hearing.      Finding the gene for hearing impairment requires:        1. <TAB>DNA samples of hearing impaired family members, taken from standard blood samples.        2. <TAB>DNA samples of members of the family without hearing impairment, taken from          standard blood samples.        3. <TAB>Results of hearing tests conducted by the audiologist for all participants.      Once all members of the family are evaluated researchers can create a pedigree. A pedigree is     like a family tree that charts members of a family with a genetic disorder, like hearing     impairment. Pedigrees are used to determine the mode of inheritance of the gene responsible     for a particular condition.      Finally, researcher intend on using all the information gathered as well as methods for     genetic analysis to map out the location of the gene. Patients participating in this study     will not directly benefit from its research, but scientific understanding achieved may help     researchers better understand the auditory system and someday prevent deafness.<TAB>   "
161978|NCT00001609|"     The objective of this study is to discover the genes responsible for the development of     hereditary cataracts in families. A cataract is clouding of the lens of the eye that     obstructs the passage of light and may impair vision. Information from this study may provide     a better understanding of why hereditary cataracts form and perhaps lead to the development     of a test that can predict who will likely be affected and to what degree.      Patients or family members of patients with inherited cataracts who participate in this study     will be asked questions about their family history, especially concerning eye disease or     cataracts, and a family tree will be drawn. They will undergo a complete eye examination,     including photographs to document the clarity or opacity of the lens. In addition, a small     blood sample will be drawn for use in gene mapping studies of inherited cataract.   "
162234|NCT00002104|"     To demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or     without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam,     and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. To     demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis     lesions, and immune responses.   "
161979|NCT00001610|"     This study will measure the normal range of the human electro-oculogram (EOG) in people of     various age groups. EOGs are recordings of electrical signals generated by the retina (the     light-sensitive tissue in the back of the eye) when going from a dark to a bright     environment. They provide valuable information about the function of the eye in health and     disease. A knowledge of what results are to be expected in tests of normal, healthy eyes will     be valuable in assessing EOG results in patients with known or suspected retinal diseases.      Normal volunteers from ages 6 to 65 who have healthy eyes and normal eyesight will     participate in this study. Candidates will undergo tests to check vision and the health of     the eye. Study participants will then have an electro-oculogram. In this test, eye drops are     placed in the eye to enlarge the pupils. Two electrodes (small disks that picks up electrical     signals) are attached to the left and right of each eye and one to the forehead. (These are     similar to electrodes placed on the body during an electrocardiogram (ECG), which measures     electrical signals from the heart.) During the EOG recording, the volunteer looks at the     inside of a hollow sphere, following with their eyes small red lights that turn on and off.     The background light is also turned on or off during the test. Some volunteers may be asked     to repeat the EOG at another time.      Study participants may also be asked to provide a blood sample for tests to study how the     immune cells in the blood respond to proteins found in the retina. The response from normal     volunteers will be compared with that of patients with eye diseases like retinitis     pigmentosa.   "
161980|NCT00001611|"     This study will investigate whether medication for cytomegalovirus (CMV) retinitis-a viral     infection of the eye-can safely be stopped in HIV-infected patients whose immune function has     improved from anti-HIV therapy. Medicines taken to fight CMV infection (ganciclovir,     foscarnet, and cidofovir) can cause serious side effects, such as low blood counts and kidney     damage. Stopping these medications may, therefore, be beneficial.      Patients with HIV infection who develop CVM retinitis usually have very low levels of     infection-fighting white blood cells called CD4 cells-less than 50 cells per microliter of     blood. New anti-HIV medications have been able to raise CD4 levels and improve immune     function in many patients. This study will see if patients with CD4 levels above 150 cells     per microliter can fight CVM retinitis without additional anti-CVM drugs.      HIV-infected patients with CVM retinitis will have a physical examination and complete eye     examination. These tests will be repeated after 2 weeks. If there is no evidence that the CMV     infection has progressed, and if it is in a location that is not immediately     sight-threatening, anti-CMV medications will be stopped. Patients will be examined every 2     weeks for 3 months and then every 3 weeks for the next 3 months. Patients whose CD4 count has     remained above 100 after 6 months will continue to be followed every 4 weeks until the CVM     infection becomes active again. At that time, anti-CVM medicines will be re-started. Patients     will also have blood and urine samples taken to test for levels of HIV and CMV in the blood     and urine, and will be interviewed about their vision and how it affects daily activities.   "
161981|NCT00001612|"     Patients enrolled in the original Early Treatment Diabetic Retinopathy Study at the Clinical     Center at Johns Hopkins Wilmer Eye Institute will be invited for a follow-up visit at the     National Eye Institute. Visual function will be assessed with manifest refraction and     standardized visual acuity measurement. The progression of retinopathy will be evaluated by     ocular exam and fundus photography. A brief medical history will be obtained. The goal of     this study is to evaluate the long-term results of patients whose diabetic retinopathy was     treated with different strategies of scatter and/or focal laser photocoagulation.   "
161982|NCT00001613|"     Cataract, in which the lens of the eye is opacified, is the major cause of blindness. This     study will examine protein material of the lens called crystallins to try to determine what     causes nuclear cataracts, a type of cataract that forms in the central lens nucleus.      Men and women age 45 years or older with a cataract may be eligible for this study.     Candidates will be screened to determine what type of cataract they have and will undergo a     complete eye examination, including a vision test, eye pressure test, and examination of the     lens and retina.      Patients selected for study will have a complete physical and eye examination, including     photography of various parts of the eye, and ultrasound measurements of the eye. They will     then have cataract surgery, either with or without intraocular lens implantation, and will     have follow-up examinations 1 week, 3 weeks, 5 weeks and 8 weeks after surgery.      Tissue from the lenses removed during surgery will be given to NEI scientists for research on     the causes of age-related nuclear cataracts.   "
161983|NCT00001614|"     Current treatment modalities for uveitis associated with juvenile rheumatoid arthritis have     not been beneficial in the juvenile population. A new approach for treating patients with     presumed autoimmune disorders is oral tolerance therapy. Chicken type II collagen (Colloral)     is being developed as an oral tolerance therapy for the treatment of rheumatoid arthritis.     This open label pilot study will describe the safety of chicken type II collagen added to     current anti-inflammatory medications as treatment for patients with uveitis associated with     juvenile rheumatoid arthritis. The primary ophthalmic outcomes of this study will be a change     from baseline in the number of anterior chamber cells and the number and dosage of     anti-inflammatory medications. Secondary outcomes for JRA will include change in physician's     global assessment, parent/patient assessment of overall well-being, functional assessment,     number of joints with active arthritis, number of joints with limited range of motion, and     erythrocyte sedimentation rate (ESR). Secondary outcomes for uveitis will include change in     visual acuity, vitreous haze, and anterior chamber flare.   "
161993|NCT00000984|"     AMENDED: As of 10/19/90 only Children 0 to 3 months are being enrolled. Original design: To     determine whether the experimental drug recombinant CD4 (rCD4), which is produced through     genetic engineering technology, is safe and well-tolerated in children infected with or at     risk for HIV infection.      rCD4 may be an effective treatment for HIV infection, based on its ability to block infection     of human cells by HIV in laboratory tests. However, the activity of rCD4 still needs to be     confirmed in clinical trials. It is hoped that these tests will show that rCD4 is both safe     and effective in treating children who are infected with or who are at risk for infection     with HIV.   "
162235|NCT00002105|"     To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the     treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the     established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of     DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.   "
161984|NCT00001615|"     Age-related macular degeneration (AMD) represents the most common cause of blindness in     patients over the age of 60. The major cause of vision loss in this disease is due to the     development of choroidal neovascular membrane formation (CNVM). Several clinical trials have     proven that eyes with well-defined CNVM or lesions that can be readily demarcated with     fluorescein angiography can be successfully treated with laser photocoagulation. However, up     to 87% of eyes present with ill-defined CNVM or lesions that cannot be well demarcated on     fluorescein angiography and are not amenable to laser photocoagulation. No beneficial     treatment for this form of choroidal neovascularization has been established.      Histopathologic study has demonstrated the presence of inflammatory and reparative responses     in the retina of patients with ill-defined choroidal neovascularization. Since     corticosteroids have been shown to downregulate many of the cellular factors involved in both     inflammation and repair, the present study is designed to assess the ability of     corticosteroid injection around the eye to prevent severe vision loss associated with     ill-defined choroidal neovascularization in the setting of age-related macular     degeneration. The study will be organized as a randomized open label control clinical trial     involving 2 phases. Phase 1 involving 40 patients will establish the feasibility and safety     of this treatment modality. Phase 2 will place emphasis on efficacy of the study.   "
161985|NCT00001617|"     This study will test the reliability of an instrument called the Quasi Elastic Laser     Scattering Device (QLS) in detecting early changes in cataract formation.      Surgery is currently the only treatment for cataracts. Many laboratories, however, are     researching drugs to reverse, delay or prevent cataract formation. Anti-cataract drugs     presumably would be most effective given early in the course of disease. When clinical trials     of these drugs are begun, dependable and standardized methods for documenting and monitoring     lens opacities will be needed to test their effectiveness. The QLS was designed to detect the     earliest molecular changes in cataract development. This study will evaluate the usefulness     and reliability of this instrument in measuring these changes.      Normal volunteers and patients with cataracts in this study will have a standard eye     examination, including a vision test and eye pressure measurement. The pupils will be dilated     for QLS testing and for examination of the retina. Photographs of the retina may be taken.     The QLS test uses a very dim laser light similar to that used to scan grocery items in the     supermarket. The laser beam is projected into the lens of the eye, and the scattered light is     collected and analyzed to determine normal and abnormal molecular interactions in the lens.     Two measurements will be done for each eye. The test will be repeated in 6 months to     determine reproducibility of the system.   "
161986|NCT00001618|"     Bronchoalveolar lavage (BAL) is a diagnostic and therapeutic procedure conducted by placing a     small fiberoptic scope into the lung of a patient, and injecting sterile water (saline) into     the lung and removing the fluid. The sterile solution removed contains secretions, cells, and     protein from the lower respiratory tract. This sample can be analyzed to provide more     information about possible disease processes going on in the lungs.      This protocol will be used to perform BAL, bronchial brushing, and bronchial wall biopsy in     normal volunteers and patients with pulmonary disease. The samples collected during the study     will be used to examine biochemical processes in the lung that may contribute to lung disease   "
161987|NCT00001619|"     Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the     human body without the use of X-ray (radiation). MRI uses different levels of magnetic fields     to create images of the body and organs. Occasionally, researchers will give patients     undergoing a MRI an injection of a substance called gadolinium. Gadolinium works by     brightening areas of the magnetic resonance image, thereby improving the contrast.      In this study researchers will use magnetic resonance imaging and contrast substances, like     gadolinium, on normal volunteers in order to evaluate different aspects of its performance.     Information gathered from this study may be used to develop more specific research studies     involving MRI.   "
161988|NCT00001620|"     This study allows the evaluation of subjects in order to determine their ability to safely     participate in other active research studies.      After subjects complete the screening process, they will be offered the opportunity to     participate in an active research study, or if no appropriate studies are available     information and recommendations will be provided for other treatment options.   "
161989|NCT00001621|"     This study was developed in order for the professional-staff at the Pulmonary-Critical Care     Medical Branch (PCCMB) of the National Heart, Lung, and Blood Institute to maintain their     skills and increase their understanding of lung diseases.      The study will permit PCCMB staff members to evaluate and treat patients with lung disease     who do not meet the criteria for other research studies.   "
161990|NCT00001622|"     A layer of cells called the endothelium line the walls of blood vessels. These cells produce     substances that control the tone of blood vessels and thus control blood flow through the     vessel. One of the substances produced involved in the control of blood vessel function is     nitric oxide. Nitric oxide (NO) plays a role in the relaxation of blood vessels.      Researchers have been interested in the function of the endothelium in patients with high     blood pressure (essential hypertension) and patients with high cholesterol     (hypercholesterolemia).      After conducting studies on the endothelium and nitric oxide, researchers have found that the     endothelium is indeed functioning abnormally in patients with high blood pressure and high     cholesterol. In addition, researchers have determined that the dysfunction is a result of     abnormalities in the nitric oxide (NO) system.      In this study researchers plan to investigate the relationship between blood vessel responses     in real-life settings versus laboratory settings in normal volunteers, patients with high     blood pressure, and patients with high cholesterol.   "
161991|NCT00000982|"     AMENDED 07/07/93: To evaluate whether continuous infusion AZT will impact neurodevelopmental     deficits associated with HIV infection or alter rate of encephalopathy progression in     children who have failed to improve or shown progression of these deficits despite optimal     AZT therapy.      AMENDED: To assess whether didanosine (ddI) will be better tolerated than AZT administered by     either continuous intravenous delivery or oral administration (ddI arm removed per amended     version).To determine whether ddI will achieve comparable clinical efficacy as the continuous     intravenous route of delivery of AZT, and to assess whether either or both of these regimens     are superior to that achieved with an intermittent AZT dosage schedule. To determine whether     there are differences in patient or parent (guardian) compliance between the three treatment     regimens. Original design: To determine whether the pharmacokinetic profile (bloodstream     levels) of zidovudine (AZT) influences its effectiveness on HIV infection in children. That     is, the study seeks to find out whether there is a difference in the effect of AZT when given     as a continuous intravenous infusion (and, if available, an oral sustained release dose)     compared to an intermittent (not continuous) dose given orally every 6 hours. The study also     plans to determine (1) whether there are differences in the tolerance and side effects     associated with AZT when given on an intermittent schedule as opposed to a steady-state     schedule; (2) the extent of variation from patient to patient in AZT levels and whether the     plasma and cerebrospinal fluid levels of AZT are related to the degree of therapeutic     effectiveness; and (3) whether there are differences in the response of children who acquired     HIV infection perinatally (just before, during, or just after the time of birth) versus those     who acquired HIV infection by transfusion.      One of the most serious effects of HIV disease in children is neuropsychological     deterioration (relating to mental and nervous system functioning). This complication affects     the vast majority of HIV infected children. A previous study of continuous intravenous     administration of AZT in pediatric patients with HIV infection showed consistent and dramatic     improvements of symptoms in all patients that had shown neurodevelopmental deficits or     abnormalities. These improvements were seen within 3 to 4 weeks after AZT treatment was     started. Neurodevelopmental improvements have been sustained on AZT, usually showing steady     improvement which, in some patients, was associated with restoration of pre-HIV intellectual     and neurological function. This study also showed an increase in the IQ scores of children     receiving continuous infusion of AZT who did not have overt clinical evidence of     encephalopathy (disease of the brain). Thus changes in cognitive function may be among the     earliest signs of AIDS encephalopathy and underscores the need to start therapies that will     treat the central nervous system in patients who appear to be clinically intact. A study     comparing continuous infusion to intermittent dosing of AZT showed a significant increase in     IQ scores for those children receiving the continuous dose compared to those treated with the     intermittent schedule. Although a portable infusion pump allows patients to receive     continuous infusion of AZT, a sustained release oral formulation that could provide a     continuous release of AZT into the bloodstream would be highly desirable.   "
161996|NCT00000987|"     To study the safety and maximum tolerated dose (MTD) of combined chemotherapy when it is     administered to patients with advanced Kaposi's sarcoma together with one of two different     doses of zidovudine (AZT).      The combination of AZT and chemotherapy may be effective in treating the tumor as well as     preventing the life-threatening infections when used for patients with AIDS and Kaposi's     sarcoma. The MTD of combined chemotherapy is being determined so that the information will be     available for future studies, when the relative effectiveness of the two doses of AZT has     been learned.   "
162236|NCT00002106|"     To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected     patients with CD4 counts of 400-700 cells/mm3.   "
161998|NCT00000989|"     AMENDED: To evaluate the effect of sargramostim ( GM-CSF ) on modulating the granulocytopenia     associated with concomitant DHPG and AZT therapy ( Phase B ), in terms of time to development     of granulocytopenia as defined by an absolute neutrophil count ( ANC ) less than or equal to     750 cells/mm3.      Original design: To determine if granulocyte-macrophage colony-stimulating factor ( GM-CSF )     is helpful in preventing the decreased numbers of white blood cells (infection-fighting     cells) associated with ganciclovir ( DHPG ) therapy and to determine if GM-CSF can be safely     used in AIDS patients with cytomegalovirus ( CMV ) retinitis.      AMENDED: In ACTG 004, among 11 AIDS patients with CMV infection receiving DHPG maintenance     therapy (5 mg/kg, 5x/week) with stable white blood cells (WBC)/absolute neutrophil counts     (ANC) 7 (64 percent) required dose reduction or discontinuation of both antiviral medications     due to granulocytopenia when AZT (600 mg/day) was added. A mean nadir ANC of 717 cells/ml was     reached at a mean of 5 weeks of concomitant DHPG/AZT therapy in these patients. While     recovery of depressed ANC occurred following discontinuation of study medications,     progressive CMV infection (most commonly retinitis) occurred in 19 of 40 patients and seemed     to be associated with DHPG therapy interruption. Only 3 of 40 patients were able to tolerate     the complete 16 week study duration of DHPG/AZT. Pharmacokinetic studies of co-administration     of DHPG and AZT revealed no significant drug-drug interactions. The study investigators     concluded that the main, treatment limiting toxicity of combination DHPG/AZT therapy is     granulocytopenia and that many patients treated on this study developed intercurrent OIs or     staphylococcal septicemia. In order to determine whether patients receiving maintenance DHPG     therapy with or without GM-CSF can tolerate concomitant AZT therapy, extended maintenance     therapy with the assigned study regimen in combination with AZT will be incorporated into     this protocol. Original design: CMV infection causes inflammation of the retina and can lead     to permanent blindness. Treatment for CMV retinitis with DHPG has been shown to be effective     in halting the progression of retinal disease. During DHPG treatment, however, about 30 to 55     percent of patients develop decreased white blood cell counts. GM-CSF, a naturally occurring     human hormone, stimulates the body's bone marrow to produce more white blood cells. Studies     with GM-CSF in AIDS patients have shown that it can significantly increase depressed white     blood cell counts in these patients.   "
161999|NCT00000990|"     To determine the safety and usefulness of zidovudine (AZT) for the treatment of children 3     months to 12 years of age. This study is designed to determine if children who are infected     with HIV and who have a special type of lung disease called lymphocytic interstitial     pneumonitis (LIP) or other early symptoms of HIV infection may derive benefit from treatment     with AZT. It is hoped that this drug will prevent children from developing additional     symptoms and infections and will help resolve already existing symptoms.      AZT has been shown in the laboratory to inhibit the infection of cells by HIV. AZT has been     shown to decrease the mortality and the frequency of opportunistic infections in certain     adult patients with symptomatic HIV infection. It is, therefore, likely that symptomatic     HIV-infected children may also benefit from specific antiviral therapy.   "
162000|NCT00000991|"     To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with     HIV infection and T4 cell count less than 200 cells/mm3. All persons completing at least 8     weeks of therapy on 081 will be offered the opportunity to participate in the nested study     (ACTG 981) of systemic antifungal therapy (fluconazole) versus local therapy (Clotrimazole)     for the prevention of serious fungal disease.      Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial     pneumonia, and other serious infections. It is therefore important to find drugs that can be     given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been     shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both     sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective     preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and     extrapulmonary pneumocystosis.   "
162001|NCT00000992|"     To test the effectiveness of itraconazole in preventing the recurrence of disseminated     histoplasmosis in AIDS patients.      Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has     been used to treat the infection. Although the response to this treatment is generally good,     up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis     infection will have a relapse (that is, they will get the disease again) within 12 months     following treatment. Ketoconazole has been used to prevent relapse, but available information     suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A     more effective therapy to prevent recurrence is needed. Itraconazole has been used     successfully to treat disseminated histoplasmosis in non-AIDS patients and it is hoped that     it may be more effective in preventing histoplasmosis relapse.   "
162002|NCT00000993|"     To prevent individuals who have had a massive accidental exposure to HIV from becoming     infected with HIV and possibly developing AIDS, by treating them with zidovudine (AZT).     Although the number of persons who have been (or will be) exposed to a high concentration of     HIV is quite small, these persons have a high risk of becoming infected and treatments are     needed to prevent infection after such an exposure. In animal studies, AZT has prevented the     development of infections after exposure of the animals to a retrovirus (the HIV is a     retrovirus). In patients with AIDS, AZT has been effective in delaying the progression of the     disease. For these reasons a trial of AZT is indicated.   "
162003|NCT00000994|"     To determine whether taking zidovudine (AZT) will change the natural course of HIV infection     in patients with AIDS-associated Kaposi's sarcoma (KS) and whether administering AZT at a     similar dose but at different intervals will reduce toxicity in a more manageable treatment     plan.      Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent.     AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will     show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether     AZT therapy will delay the development of opportunistic infections and/or KS lesions.   "
162004|NCT00000995|"     To evaluate the clinical and laboratory toxicity of ganciclovir (GCV) and zidovudine (AZT)     when given in combination.      Because recent information has shown AZT to be useful in treating AIDS, it is assumed that     most patients with AIDS, and probably with AIDS related complex (ARC), will be receiving AZT.     Because AZT is reported not to be active against cytomegalovirus (CMV), it is important to     see if it is useful to give GCV along with AZT.   "
165740|NCT00005509|"     To conduct a cross-sectional study of cardiovascular risk factors in a cohort of Latina     women.   "
162006|NCT00000997|"     To determine how much of a dose is absorbed by the body when zalcitabine ( dideoxycytidine;     ddC ) is given orally and how long the drug stays in the body after absorption or intravenous     (IV) administration.      Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test     tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug     and how long the drug remains in the body at each of six doses. This should be useful     background information and should allow a simple and efficient comparative study of any new     oral formulation, such as a tablet or capsule, since dose-related problems will already be     known.   "
162325|NCT00002195|"     The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV     regimen that includes retrovir plus epivir.   "
162009|NCT00001000|"     To evaluate the degree and sequence of immunologic enhancement and the cellular resistance to     certain infections after a single dose of atvogen (ampligen). In addition, the relationship     between activation of immune cells and biochemical markers of that activation will be     studied.      Treatment of patients with HIV infection must address both the primary viral infection and     the subsequent immune deficiency, which is the primary cause of mortality in AIDS. In vitro     studies of ampligen have shown it will inhibit HIV infection. Ampligen may also minimize the     toxicity of many drugs used in the treatment of AIDS and induce an antiviral state in the     brain that may be useful in treating neurologic symptoms of HIV infection. The time course     and degree of immunologic response to ampligen remain unknown although they are essential for     proper use of the drug in the treatment of HIV infection and perhaps other clinical problems.   "
162010|NCT00001001|"     To examine the pharmacokinetics (blood levels) and bioavailability of zidovudine (AZT) given     to patients with HIV infection and chronic liver disease. The specific aim of the study is to     provide data permitting the development of guidelines for use of AZT in patients with mild,     moderate, or severe liver disease.      AZT is the only antiviral agent that has been shown to be effective in patients with severe     HIV infection. However, AZT is largely eliminated from the body through a biochemical     reaction that takes place in the liver, and it is possible that patients with underlying     liver disease may have altered AZT pharmacokinetics and may metabolize AZT differently, with     the result that they are susceptible to an increased risk of serious drug toxicity. This     study will examine the pharmacokinetics, elimination, and metabolism of AZT in patients with     liver disease. Guidelines developed from the data will be helpful in managing AZT treatment     of these HIV-infected persons and will indicate whether the dose of AZT administered should     be adjusted to compensate for any changes in its bioavailability and/or pharmacokinetics.   "
162011|NCT00001002|"     To study the toxicity, pharmacokinetics, and antiretroviral effectiveness of combined oral     zidovudine (AZT) and intermittent intravenous foscarnet therapy in stable AIDS or AIDS     related complex (ARC) patients who have already received AZT for 8 - 52 weeks.      It is hypothesized that the maximum AZT antiretroviral effect, which occurs at 8 weeks of     therapy, will be enhanced by 2 weeks of foscarnet treatment, given at the same time by     intermittent intravenous infusion. In addition, the further lowering of serum p24 antigen     concentration that should occur during combined therapy might continue when oral AZT therapy     is continued without foscarnet.   "
162012|NCT00001003|"     To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with     advanced HIV disease and T4 cell count < 200 cells/mm3. To establish the range of pentamidine     (PEN) deposition in AIDS patients participating in ACTG 021 and ACTG 081. To identify factors     (breathing pattern, pulmonary function) that may be important in affecting the actual dose     delivered to a given patient.      The specific system that is used to deliver PEN to the lungs may determine whether a     therapeutically effective dose is attained in the lungs. Therefore, this study will establish     the amount of PEN that is deposited in the lungs of patients enrolled in protocols ACTG 021     and ACTG 081, who are being treated with PEN administered from the Marquest Respirgard II     nebulizer.   "
162013|NCT00001004|"     To study the tolerance and toxicity of the combination of tumor necrosis factor (TNF) and     interferon gamma (IFN-G) or as single agent TNF or IFN-G in HIV infected patients. To     selectively monitor the immune system of AIDS related complex (ARC) patients who receive     either combination therapy or TNF or IFN-G alone. To obtain information on the effectiveness     of combination therapy or TNF or IFN-G alone against HIV in ARC patients.      Recombinant TNF and recombinant IFN-G have been shown to be effective against the virus which     causes AIDS and ARC in some laboratory studies, but may increase virus replication in other     laboratory studies. Previous studies in humans showed no increase in virus cultures and some     decrease in measurements of virus. Extensive preclinical data show that TNF and IFN-G are     more effective together than separately in laboratory and animal studies. As single agents,     both TNF and IFN-G have modest effect against HIV. Studies have demonstrated that TNF and     IFN-G, in combination, can not only inhibit HIV infection of previously uninfected cells, but     also can selectively induce the destruction of acutely infected target cells.   "
162023|NCT00001014|"     To compare the safety and effectiveness of an investigational drug therapy (trimetrexate plus     leucovorin calcium) with that of conventional therapy (sulfamethoxazole-trimethoprim) in the     treatment of moderately severe Pneumocystis carinii pneumonia (PCP) in patients who have     AIDS, are HIV positive, or are at high risk for HIV infection. New treatments are needed to     reduce the mortality rate from PCP in AIDS patients and to reduce the high relapse rate found     after conventional therapy. Trimetrexate (TMTX) was chosen for this trial because it was     found to be much more potent than sulfamethoxazole/trimethoprim (SMX/TMP) against the PCP     organism in laboratory tests. Also TMTX, in combination with leucovorin (LCV), did not cause     severe toxicity in a preliminary trial. It is believed that TMTX will be more effective in     treating PCP and in preventing a recurrence of PCP.   "
162014|NCT00001005|"     AMENDED: To investigate whether subcutaneous (SC) injection of IL-2 produces biological     responses which parallel those observed with IV dosing. Original design: To evaluate the     short-term effects of combined administration of zidovudine (AZT) and increasing doses of     recombinant interleukin-2 (aldesleukin; IL-2) in patients infected with HIV, who have     lymphadenopathy, but who are otherwise asymptomatic (no other symptoms). The first phase of     this clinical trial will establish maximum tolerated dose ( MTD ). How quickly the drugs get     into the blood and how long they remain there (pharmacokinetics) will also be studied at each     dose as well as the effect on HIV.      Since AZT has no effect on cells that contain inactive virus (latently infected cells) and     these cells may act as viral reservoirs, that a second agent that can destroy these infected     cells would be useful in combination with AZT. The different activities of AZT and IL-2, as     well as the non-overlapping nature of their mechanisms of action and toxicity, increase the     theoretical benefits of combining AZT, a drug which has clinically significant activity in     HIV-related disease but cannot eliminate infected cells, with IL-2, a drug which may enhance     anti-HIV immunity, destroy chronically infected cells, and allow immune recognition of     latently infected cells.   "
162186|NCT00002056|"     This is a randomized double-blinded controlled study comparing aerosolized pentamidine with     trimethoprim plus sulfamethoxazole (TMP / PurposeX). The latter drug will be administered     intravenously for at least 5 days, then changed to oral administration if warranted by the     patient's clinical condition.   "
162015|NCT00001006|"     To determine the toxic effects of AS-101 at various doses in patients with AIDS or AIDS     related complex. Also to determine the effect of various doses of AS-101 on immune functions     and the occurrence of infections in these patients. AIDS is a viral disease that is     characterized by a loss of some immune function and the development of frequent, eventually     fatal, infectious diseases. Although zidovudine (AZT) has prolonged survival in some patients     with AIDS, AZT is quite toxic and there is a need for more effective and less toxic drugs.     AS-101 is a synthetic organic compound containing the metal tellurium that is being tested     because in laboratory studies it improved immune functions.   "
162016|NCT00001007|"     To determine if intravenous (IV) and oral zidovudine (AZT) can be safely given to children     aged 1 day to 3 months who were born to mothers with an HIV infection. Also to determine the     correct dose of AZT for young children. Of a total of 908 pediatric AIDS cases, 78 percent     have acquired HIV infection from a mother with HIV infection or at high risk for acquisition     of HIV, and the number of cases in children is expected to increase over the next several     years. AZT therapy may be effective in altering the course of the disease and decreasing the     high mortality in these children. It is also possible that early intervention with AZT may     prevent the establishment of HIV contracted before, during, or just after birth.   "
162017|NCT00001008|"     To determine if methadone treatment will affect the blood levels of zidovudine (AZT) in     patients with AIDS or AIDS-related complex (ARC) who are receiving oral AZT and methadone     therapy. In addition, the blood levels of methadone both before and during AZT treatment will     be studied, and patients receiving daily oral methadone treatment will be evaluated for signs     of narcotic withdrawal during treatment with AZT.      The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide     approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very     likely that an increasingly larger number of AIDS patients receiving AZT therapy will have     had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily     methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large     number of patients who will undergo long-term treatment with both methadone and AZT.     Therefore, the study of potential drug interactions is essential.   "
162018|NCT00001009|"     To determine the effectiveness and safety of dextran sulfate (DS) as a treatment for patients     with AIDS, AIDS related complex (ARC), or asymptomatic HIV infection with or without     persistent generalized lymphadenopathy (PGL), and to determine antiviral activity at     different doses of DS. Although zidovudine (AZT) has shown promise in prolonging life in     patients with AIDS and severe ARC, it has significant blood toxicities. It would be     beneficial to combine AZT with another antiviral agent that does not have the same toxicity.     DS might be a suitable drug since it has shown antiviral activity against HIV in the     laboratory, and in preliminary studies it has shown little toxicity. Also, the combination of     DS with AZT has been shown to be more effective than either alone.   "
162019|NCT00001010|"     To compare the effect of zidovudine (AZT) given alone with the combination of AZT and     acyclovir (ACV) on the human immunodeficiency virus (HIV) in persons infected with HIV, and     to study the pharmacokinetics (how fast AZT reaches certain levels in blood and how long it     remains), safety, and effectiveness of AZT given alone and in combination with ACV in     treating HIV-infected patients. Other studies have shown that AZT offers potential benefits     to specific AIDS patients when given over long time periods, and experiments in vitro (in the     test tube) suggest that ACV may stimulate the action of AZT against HIV. It is necessary to     obtain information on how these drugs perform in HIV-infected humans.   "
162020|NCT00001011|"     To determine the safety and usefulness of zidovudine (AZT) for the treatment of patients with     early symptomatic HIV infection or early AIDS related complex (ARC). The ability of AZT to     suppress HIV, to improve body defenses, and to prevent the occurrence or development of AIDS     or advanced ARC is being evaluated.      In one human study, patients with AIDS or advanced ARC who received AZT had fewer     life-threatening infections, improved in weight and performance, and lived longer than     patients who received a placebo (inactive medication). Further studies are needed because     toxic effects associated with the use of AZT were noted and the long-term effectiveness and     toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less     severe HIV infections such as early ARC or PGL.   "
162021|NCT00001012|"     To study the tolerance and safety of increasing doses of AL-721 in patients with persistent     generalized lymphadenopathy (PGL) and symptomatic HIV infection, and to obtain preliminary     information on the effectiveness of AL-721 against the human immunodeficiency virus (HIV) in     HIV-infected persons with PGL and symptomatic HIV infection. Although zidovudine (AZT)     prolongs life in certain AIDS patients, it is not a cure for AIDS and it also has toxic     effects in many patients. Therefore, it is necessary to test other drugs in HIV-infected     patients. AL-721 is a mixture of lipids (fats) extracted from egg yolks. Laboratory tests     suggest that it might inhibit the infectivity of the HIV. AL-721 has been tried so far in a     few patients for short periods of time and has been found to be well tolerated.   "
162256|NCT00002126|"     To determine, in HIV-infected patients, the efficacy of filgrastim ( recombinant-methionyl     human granulocyte-colony stimulating factor; G-CSF ) in preventing grade 4 neutropenia, i.e.,     absolute neutrophil count (ANC) < 500 cells/mm3.   "
162024|NCT00001015|"     To determine the maximum long-term dosage of ribavirin (RBV) that is safe and free of serious     side effects in patients with AIDS or AIDS related illnesses. Also, to determine what effect     different dosage levels have on biologic markers of efficacy, such as the amount of the AIDS     virus (HIV) or number of T cells in the patient's blood.      RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with     little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was     well tolerated and safe, and this favorable result suggested that RBV should be more     extensively studied in patients with AIDS and advanced AIDS related complex (ARC).   "
162174|NCT00002044|"     The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the     treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a     lymphotropic and neurotropic virus which can affect both the central and peripheral nervous     systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent     state, with the potential for continuous reinfection of other body systems. Therefore,     effective therapeutic efforts against HIV infection should provide effective antiviral     activity within the nervous system.   "
162025|NCT00001016|"     To determine the safety and effectiveness of an investigational drug trimetrexate (TMTX) with     leucovorin rescue (LCV) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients     who have AIDS, are HIV positive, or are at high risk for HIV infection, and who have     demonstrated serious adverse effects from the conventional therapies for PCP.      The drugs usually used to treat PCP in AIDS patients (trimethoprim / sulfamethoxazole and     pentamidine) have had to be discontinued in many patients because of severe adverse effects.     Currently there are no proven alternatives to these drugs. TMTX was chosen for this trial     because it has been found to be very active against the PCP organism in laboratory tests. In     a preliminary trial, TMTX in combination with LCV has been effective against PCP with fewer     and less severe adverse effects.   "
162026|NCT00001017|"     To compare the safety and effectiveness of a new drug, fluconazole, with that of the usual     therapy, amphotericin B, in the prevention of a relapse of cryptococcal meningitis (CM) in     patients with AIDS who have been successfully treated for acute CM in the last 6 months.      Cryptococcal meningitis is a life-threatening infectious complication of AIDS. Because     relapse after treatment occurs in over 50 percent of cases, chronic maintenance therapy with     intravenous (IV) amphotericin B is usually given. However, amphotericin B is not always     effective, has toxic effects, and must be given by the intravenous route. Fluconazole is an     antifungal agent that can be given orally and has been shown to be effective against     cryptococcal infections in animals and against acute CM in a few AIDS patients. Also, the     side effects experienced by over 2000 patients or volunteers given fluconazole have seldom     been severe enough to require withdrawal of the drug.   "
162027|NCT00001018|"     To determine the pharmacokinetic profile of single doses of letrazuril in patients with     AIDS-related cryptosporidial diarrhea; to determine the dose proportionality of single     escalating doses of letrazuril; to determine steady-state concentrations of letrazuril; to     evaluate the safety and efficacy of escalating doses of letrazuril, compared with placebo,     for patients with AIDS-related cryptosporidial diarrhea.      Letrazuril, the p-fluor analog of diclazuril, has been shown in an animal model to prevent     infections by organisms closely related to the intracellular parasite Cryptosporidium.     Reliable data are needed to show the effectiveness of letrazuril in treating AIDS-related     cryptosporidial diarrhea.   "
162028|NCT00001019|"     Part A: To compare the safety and immunogenicity of two dose levels of gp120 (CHO) in MF59     emulsion alone or with MTP-PE/MF59 adjuvant, administered at 0, 1, and 6 months.      Part B: To evaluate the safety and immunogenicity of gp120 in MF59 when administered in five     monthly injections.      One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is     manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed     against gp120 can neutralize HIV-1, and gp120 can also stimulate certain types of     cell-mediated immune responses. Because many immunogens, including candidate HIV vaccines,     may evoke relatively weak immune responses, the use of adjuvants, or substances that augment     immune responses to vaccines, is of interest. MTP-PE/MF59, composed of the immunomodulator     MTP-PE combined with MF59 emulsion, appears to be a promising adjuvant and has been selected     for studies with the gp120 vaccine.   "
162029|NCT00001020|"     AMENDED 11/17/93: To determine whether the pattern of response to MN rgp120 vaccine is     altered by pre-exposure to IIIB rgp120.      ORIGINAL DESIGN: To evaluate the safety (clinical and immunologic) of rgp120/HIV-1IIIB     vaccine (gp120 vaccine) immunization in healthy HIV-1 seronegative adult subjects. To compare     the immune response to 100 mcg gp120 vaccine versus 300 mcg gp120 vaccine. To determine     whether gp120 vaccine immunization causes a significant immune response as defined by     specific parameters (e.g., induction of neutralizing antibodies to the IIIB isolate of HIV-1,     gp120 antigen-specific lymphocytic proliferation).      Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a     vaccine against HIV-1 infection. The gp120 envelope protein may be produced by recombinant     DNA technology, and studies have shown that the vaccine is capable of eliciting neutralizing     antibody activity in both rodents and nonhuman primate species.   "
162030|NCT00001021|"     AMENDED 10/1/93: To evaluate the influence of prior immunization with an rgp120 vaccine on     immune response to a subsequent immunization with a different strain of rgp120 (VEU 009X     extension - in patients previously enrolled on VEU 009).      ORIGINAL DESIGN: To evaluate the clinical and immunologic safety of MN rgp120/HIV-1 vaccine     (MN rgp120 vaccine) given alone or concurrently with the IIIB rgp120/HIV-1 vaccine (IIIB     rgp120 vaccine) in healthy HIV-1 seronegative adult subjects. To compare the immune response     to MN rgp120 vaccine given at 100, 300, or 600 mcg. To determine the immune response to 300     mcg MN rgp120 vaccine and 300 mcg IIIB rgp120 vaccine given concurrently.      Recent studies suggest that immunity to the HIV-1 rgp120 protein may prevent primary     infection. MN rgp120 vaccine and IIIB rgp120 vaccine are both prepared by recombinant DNA     technology. Because the two vaccines are derived from distinct HIV-1 strains, they may elicit     some immunologic responses that differ. Unlike IIIB rgp120 vaccine, the MN rgp120 vaccine has     not yet been evaluated in humans, although it is expected that the MN type will result in     similar safety and immunogenicity as the IIIB type.   "
162031|NCT00001022|"     Primary: To compare the efficacy of zidovudine ( AZT ) given alone versus AZT plus didanosine     ( ddI ) versus AZT plus zalcitabine ( dideoxycytidine; ddC ) in delaying the occurrence of     AIDS-related conditions in HIV-infected patients.      Secondary: To compare the frequency and severity of adverse experiences in the three     regimens. To compare the mortality rates in the three regimens. To compare the effects of     antiretroviral regimens on CD4+ cell levels.      Studies have indicated that maintenance therapy with AZT over extended periods may be limited     by dose-dependent toxicity, primarily myelosuppression, and by the emergence of     drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or     ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of     development of drug-resistant strains, than AZT alone.   "
162175|NCT00002045|"     To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) to adult     patients with early manifestations of HIV disease. To assess the efficacy of AZT therapy in     the treatment of HIV disease in these patients.      (12/01/89) Information supplied by drug company update. Study discontinued due to positive     data from ACTG 016.   "
162176|NCT00002046|"     To evaluate the pharmacokinetics of Retrovir (AZT) administered orally as 1 of 3 doses in the     treatment of patients with severe clinical and laboratory manifestations of HIV infection. To     compare the safety and tolerance of AZT administered 2, 3, and 6 x daily to these patients.   "
162032|NCT00001023|"     PER 03/10/94 AMENDMENT: PART B. To determine whether there is an effect on plasma drug levels     of azithromycin and rifabutin as measured by changes in the plasma concentration-time curve     (AUC) when these drugs are taken concomitantly.      ORIGINAL PRIMARY: To gain preliminary information about the safety and tolerance of     clarithromycin and azithromycin in combination with rifabutin (three potential agents against     Mycobacterium avium-intracellulare) in HIV-infected patients with CD4 counts < 200 cells/mm3.      ORIGINAL SECONDARY: To determine whether there is an effect on the pharmacokinetics of the     macrolide antibiotics or rifabutin when these drugs are taken concomitantly. To monitor the     effect of rifabutin therapy on dapsone serum levels in patients taking dapsone for PCP     prophylaxis. To monitor the effect of macrolide/rifabutin combination therapies on AZT or ddI     serum levels.      Two new macrolide antibiotics, clarithromycin and azithromycin, and rifabutin (a rifamycin     derivative) have all demonstrated in vitro and in vivo activity against Mycobacterium     avium-intracellulare, a common systemic bacterial infection complicating AIDS. Further     information is needed, however, regarding the clinical and pharmacokinetic interaction of     these drugs used in combination.   "
162033|NCT00001024|"     Immunopathogenesis objectives: To compare and quantitatively determine HIV burden and HIV     replication in peripheral blood (PB) and lymphoid tissue (LT). To determine the degree to     which antiretroviral therapy alters HIV replication in LT.      Clinical objectives: To gain insight into the degree of correlation between immunologic     surrogate markers for HIV disease (e.g., CD4, beta-2 microglobulin) as compared to measures     of HIV replication in PB and LT. To assess changes in PB and LT viral burden after     antiretroviral therapy and to determine its ability to predict an antiviral response.      One of the major problems in defining the immunopathogenic changes in HIV infections has been     the inability to correlate the extent of loss of immunologic function with the number of     HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden     in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount     of HIV virus or markers for the virus in the body's lymph tissue is a better measure of     disease progression than the amount of virus or markers for the virus in the blood.   "
162034|NCT00001025|"     To determine the relationship of viral susceptibility to zidovudine (AZT) and baseline viral     load (as determined by plasma viremia and quantitative endpoint dilution). To determine the     relationship between viral load and susceptibility during different antiretroviral therapy     strategies. To correlate measures of viral load and short term clinical and laboratory     markers (such as weight, CD4 count, p24 antigenemia, and beta2 microglobulin) on the     different therapy arms.      High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent     of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical     significance of in vitro AZT resistance, it is necessary to distinguish between clinical     failure caused by AZT resistance and clinical decompensation caused by other factors.   "
162035|NCT00001026|"     Primary: To determine whether combination vaccination, i.e., priming with a vaccinia     recombinant-containing HIV envelope (HIVAC-1e) followed by boosting with a recombinant     subunit envelope protein (gp160 or gp120), provides enhanced immunogenicity compared to     subunit vaccination with the individual recombinant envelope proteins only. To compare the     relative immunogenicity of a panel of HIV envelope subunit vaccines when administered as     boosters following recombinant HIV-vaccinia priming. To evaluate the relative immunogenicity     of one versus two doses of recombinant HIV-vaccinia prior to the subunit protein boost.      Secondary: To examine the safety of administering the individual subunit vaccines in     combination with the HIV envelope vaccinia recombinant, and to extend the population to whom     these proteins have been administered.      Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting     with subunit envelope proteins offers the most promising strategy to date for a safe and     immunogenic vaccine in humans. This study will further examine the combination vaccine     approach and define an optimal prime-boost strategy.   "
162036|NCT00001027|"     Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous     pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are     intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of     these regimens in this patient population.      Secondary: To obtain information on the rate of PCP breakthrough in infants and children     receiving parenteral pentamidine prophylaxis.      Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected     children considered to be at high risk. In children younger than 5 years of age with     intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful     alternative.   "
162037|NCT00001028|"     To compare the safety and efficacy of aerosolized pentamidine and dapsone in the prevention     of Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients who are intolerant     to trimethoprim and/or sulfonamides.      Both aerosolized pentamidine and dapsone have been shown to prevent PCP, but both drugs cause     side effects. This study attempts to determine which drug is more efficacious as prophylaxis     against PCP in patients who cannot tolerate trimethoprim/sulfamethoxazole.   "
162038|NCT00001029|"     To compare the efficacy, safety and tolerance, and other clinical and immunologic effects of     zidovudine (AZT) plus zalcitabine (dideoxycytidine; ddC), AZT plus didanosine (ddI), and AZT     alternating monthly with ddI as measured by differences in survival among HIV-infected     persons who have received 6 or more months of nucleoside monotherapy and have a CD4 count     greater than or equal to 50 cells/mm3.      Combining two nucleoside drugs has the theoretical advantage of optimal protection against     the evolution of resistant strains of HIV. However, one major problem with combination     nucleoside therapy in patients with advanced disease is the increased toxicity resulting from     such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits     of combination therapy is to alternate the two drugs.   "
162124|NCT00001638|"     This study is directed at evaluating patients with myocardial ischemia or poor blood supply     to the heart muscle due to coronary artery disease. The major objective of this study is to     determine the level of safety and effectiveness of magnetic resonance imaging at diagnosing     coronary artery disease.      In addition, this study will allow researchers at the National Institutes of Health to see a     broad spectrum of disease, preserve clinical skills, and stimulate future ideas for clinical     research....   "
165741|NCT00005510|"     To examine the relationship of obesity and body fat distribution to lipoprotein     concentrations in members of the Strong Heart Study.   "
162039|NCT00001030|"     To compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the     two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC)     bacteremia or disseminated MAC disease. To compare other parameters such as survival,     toxicity, and quality of life among the three treatment arms. To obtain information on the     incidence and clinical grade of targeted gynecologic conditions.      Persons with advanced stages of HIV are considered to be at particular risk for developing     disseminated MAC disease. The development of an effective regimen for the prevention of     disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly     the mortality associated with this disease and its treatment.   "
162040|NCT00001031|"     To evaluate the safety and immunogenicity of SF-2 rgp120 vaccine in MF59 versus MN rgp120     vaccine in alum in volunteers who are seronegative for HIV-1. AS PER AMENDMENT 07/02/97: To     determine the ability of immunization with MN rgp120/HIV-1 in combination with alum or SF-2     rgp120 in combination with MF59 to induce an HIV-1 envelope-specific delayed-type     hypersensitivity (DTH) response in volunteers who receive rsgp120/MN skin testing.      The amino acid sequence of HIV-1 gp120 can vary as much as 40 percent from isolate to     isolate. Thus, the identification of an immunogen that can elicit broadly neutralizing     antibodies to HIV-1 is a major challenge in AIDS vaccine development. Two candidate vaccines,     recombinant envelope subunit proteins from the SF-2 and MN isolates of HIV-1, have shown     immunogenicity and good tolerance in healthy immunocompetent adults. This study will expand     testing into a larger population base, particularly targeting individuals at high risk for     HIV infection.   "
162041|NCT00001032|"     PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and     zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated     children.      SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and     laboratory markers of disease progression, as determined by virologic and immunologic     determinations. To evaluate the influence of combination therapy on disease progression as     determined by evaluation of clinical criteria.      In children currently being treated with AZT, it is unknown whether the addition of another     antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will     examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT     alone.   "
162042|NCT00001033|"     PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse     after therapy between two durations of intermittent therapy (6 versus 9 months) for the     treatment of pulmonary tuberculosis (TB) in HIV-infected patients. To compare toxicity,     survival, and development of resistance in these two regimens.      ORIGINAL: To compare the efficacy and safety of induction and continuation therapies for the     treatment of pulmonary TB in HIV-infected patients who are either from areas with known high     rates of resistance to one or more anti-TB drugs or from areas where TB is expected to be     susceptible to commonly used anti-TB drugs.      PER 5/30/95 AMENDMENT: In HIV-negative patients, intermittent anti-TB therapy has been shown     to be as effective as daily therapy, but the optimal duration of therapy in HIV-infected     patients has not been established.      ORIGINAL: In some areas of the country, resistance to one or more of the drugs commonly used     to treat TB has emerged. Thus, the need to test regimens containing a new drug exists.     Furthermore, the optimal duration of anti-TB therapy for HIV-infected patients with TB needs     to be determined.   "
162043|NCT00001034|"     To evaluate the safety and efficacy of oral ganciclovir for prophylaxis against     cytomegalovirus (CMV) retinal and gastrointestinal mucosal disease in HIV-infected patients     with severe immunosuppression.      The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until     recently, both drugs required intravenous administration. An oral form of ganciclovir, if     shown to be effective therapy against CMV, would be a more suitable method of administration     for prophylaxis.   "
162044|NCT00001035|"     To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with     nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the     efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV     infections treated with nucleoside analog therapy.      IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic     hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive     patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients     with advanced HIV infection has not been determined.   "
162045|NCT00001036|"     To determine the safety of thymosin alpha 1 given twice weekly in a regimen of daily oral     zidovudine (AZT) and biweekly polyethylene glycolated interleukin-2 (PEG IL-2). To determine     the effect of thymosin alpha 1 and PEG IL-2 in combination with AZT on immunologic and     pharmacokinetic markers.      AIDS is characterized by diminished T helper cell number and function. Thymosin alpha 1     appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte     maturation in vivo; thus, the drug may further enhance the CD4 T cell levels in patients     receiving AZT and PEG IL-2.   "
162046|NCT00001037|"     To determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine (Immuno-AG) versus     placebo, administered on two immunization schedules to healthy volunteers. Per 06/15/94     amendment, to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth     immunization at 9 or 11 months after the third injection (i.e., at month 17).      A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and     immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger     proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a     gp160 vaccine derived from the MN strain is important.   "
162055|NCT00001046|"     PRIMARY: To evaluate the short-term safety of rgp120/HIV-1SF2 vaccine versus MF59 placebo     administered to HIV-infected pregnant women.      SECONDARY: To evaluate the immunogenicity and long-term safety of rgp120/HIV-1SF2 in     HIV-infected pregnant women who received the vaccine during pregnancy only or during     pregnancy and postpartum. To evaluate immunogenicity and safety in the infant through 18     months of age following maternal immunization with the vaccine during pregnancy.      Active immunization of HIV-infected women during pregnancy may slow the progression of     maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of     epitope-specific antibody. Also, active immunization has the potential to induce primary     immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the     mothers.   "
165742|NCT00005511|"     To determine intermediate traits for sleep apnea in a case-control study.   "
162047|NCT00001038|"     PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention     of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+     lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and     low-dose oral acyclovir on survival.      SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug     administered concurrently with standard antiretroviral agents and other essential therapies     for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in     suppressing activation of other herpesviruses. To evaluate serologic and virologic risk     factors for the development of CMV disease, including assessment of HIV activation, and the     risk of developing drug-resistant CMV, HSV, and VZV.      Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in     patients with advanced HIV disease, although there is evidence that high doses of the drug     may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after     oral administration, has a higher absorption rate and may therefore provide inhibitory     activity against CMV.   "
162048|NCT00001039|"     To assess the feasibility of using culture and staining techniques to quantify tissue     Mycobacterium avium Complex (MAC) burden in bone marrow. To correlate and compare changes in     MAC bone marrow burden with quantitative MAC blood culture results at baseline and after 4     and 8 weeks of treatment.      MAC is easiest to detect in the blood, although doctors generally believe that MAC in blood     is just spill-over from infection of other parts of the body. Traditionally, studies of     potential treatments for MAC focus only on MAC changes in the blood. This study compares MAC     changes in blood to those in bone marrow, which is another tissue where MAC is often found.   "
162049|NCT00001040|"     PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir     mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC)     vs. Ro 31-8959 plus AZT plus ddC.      SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of     the three regimens.   "
162050|NCT00001041|"     To evaluate the safety of rgp120/HIV-1MN vaccine in HIV-1 infected pregnant women with CD4     counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and     the passive acquisition of vaccine-specific antibody in their infants. To evaluate the     induction or augmentation by rgp120/HIV-1MN vaccine of mucosal immune response in the     gastrointestinal and reproductive tracts during pregnancy. To isolate and genetically     characterize the HIV-1 present in cervicovaginal fluid specimens of pregnant women and     compare it to that present in their peripheral blood mononuclear cells and to that of their     infected infants.      Evidence suggests that an advanced stage of disease with high plasma viremia is associated     with increased transmission of HIV-1 to the fetus. Slowing the progression of disease,     reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody     are potentially attainable goals through active immunization of the mother during pregnancy.   "
162051|NCT00001042|"     To determine in healthy HIV-negative volunteers the safety and immunogenicity of     rgp120/HIV-1SF2 (BIOCINE) formulated with each of seven adjuvants.      PER AMENDMENT 3/6/96: Purpose of the extension study - To determine the ability of     immunization with rgp 120/SF-2 to induce an HIV-1 envelope-specific delayed-type     hypersensitivity (DTH) response in volunteers who receive rsgp 120/MN skin testing.      One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine     the immunogen with an adjuvant. Adjuvants may augment vaccine immunogenicity by several     mechanisms, and as a result induce a more favorable antibody response with high titers, which     appear earlier in the course of immunization and persist over time.   "
162052|NCT00001043|"     AMENDED 8/94: To expand the safety and immunogenicity profile of MN rgp160 vaccine     (Immuno-AG) by administering a higher dose (800 mcg) at 0, 1, 6, and 12 months and 0, 2, 8     and 14 months (these two schedules were compared in VEU 013A using a dose of 200 mcg). To     obtain plasma following the fourth immunization. To evaluate skin test reactivity.      ORIGINAL (replaced): To determine in healthy volunteers the safety and immunogenicity of two     immunizations of MN rgp160 vaccine (Immuno-AG) in combination with a live recombinant     vaccinia virus LAV HIV-1 gp160 vaccine (HIVAC-1e) versus DryVax (the standard smallpox     vaccine that was used for many years) control in combination with placebo.      ORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of     HIV-1 in the United States, has been developed. A previous study showed that a combination     vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160     subunit vaccine, resulted in humoral and cellular immune responses of greater and longer     duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN     rgp160 vaccine merits investigation.   "
162053|NCT00001044|"     PRIMARY: To examine the safety and potential improvement in immune responses elicited by     combining rsgp120/HIV-1MN with the adjuvant QS-21. SECONDARY: To examine the role of alum in     the vaccine/adjuvant formulation; to determine the optimal dose ratio of vaccine to adjuvant;     and to obtain initial information on the optimal schedule of administration. AS PER AMENDMENT     07/02/97: To determine the ability of immunization with rsgp120/HV-1MN in combination with     QS21 with or without alum to induce an HIV-1 envelope-specific delayed-type hypersensitivity     (DTH) response in volunteers who undergo rsgp120/MN skin testing.      Immune responses in HIV-uninfected individuals receiving subunit envelope vaccines formulated     with alum adjuvant suggest that functional antibodies capable of neutralizing HIV-1 in vitro     may be induced, but the titers are relatively low in comparison to those measured in     individuals with natural HIV-1 infection. These limitations might be overcome by the addition     or substitution of a more suitable adjuvant such as QS-21.   "
162054|NCT00001045|"     To validate that the alteration of codon 215 of reverse transcriptase in plasma virus     precedes the increase in viral burden as measured in the peripheral blood and the decline in     CD4 count that have been observed in association with clinical failure on zidovudine (AZT).     To determine whether alternative regimens of antiretroviral agents alter the course of viral     burden as measured in the peripheral blood and CD4 changes in patients with HIV infection. To     obtain further data on the safety and immunologic and virologic response to     AZT/didanosine/nevirapine.      Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at     codon 215 of the reverse transcriptase gene is the most commonly occurring and has the     greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent     further immunologic and virologic deterioration.   "
162057|NCT00001048|"     To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either     didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine     (Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or     improvement of neurological function over 6 months in HIV-infected individuals who have     developed progressive multifocal leukoencephalopathy (PML). To compare the effect of these     three treatment regimens on Karnofsky score and MRI studies.      The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus     (designated JC virus) infection, has not been determined, although the most encouraging     results have occurred with intrathecal administration of the drug.   "
162058|NCT00001049|"     To determine the pharmacokinetics, safety, and efficacy of didanosine (ddI) alone or in     combination with zidovudine (AZT) in HIV-infected infants.      PER AMENDMENT 4/8/97: Part A study objectives are completed. Part B objectives: To assess the     safety, toxicity, and tolerability and to compare anti-HIV activity, as measured by change in     log10 RNA, of the two study arms.      Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and     rapid decline of CD4 count and immunologic function. Combination therapy may be preferred     over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is     little information on ddI monotherapy in young infants less than 90 days and no information     on the use of combination therapy in this population.   "
162059|NCT00001050|"     To study the effect of pregnancy, age, drug use, and coinfections on HIV progression rate. To     document the prevalence, incidence, characteristics, and course of HIV infection and     anogenital intraepithelial neoplasia among HIV-positive and HIV-negative women. To study the     effect of HIV disease on gynecologic health including infections and reproductive function.   "
162060|NCT00001052|"     To extend the evaluation of safety and immunogenicity of MN recombinant soluble gp120/HIV-1     (MN rsgp120/HIV-1) in combination with QS21 with or without alum and on two different     vaccination schedules.      Recent animal studies indicate that immunizing with MN rsgp120/HIV-1 in combination with QS21     on a 0, 1, 2 month schedule results in a more rapid rise in binding and neutralizing antibody     response than on a 0, 1, 6 month schedule. Such an effect may be particularly desirable in     vaccine delivery. This study compares these two delivery schedules using the unadjuvanted     vaccine formulation rsgp120/HIV-1 with or without addition of alum.   "
162061|NCT00001053|"     To evaluate the safety and immunogenicity of HIV p17/p24:Ty-VLP (virus-like particles)     vaccine in uninfected volunteers. Specifically, to determine whether the vaccine formulated     with and without alum induces CD8+ cytotoxic T lymphocytes ( CTLs ) that may be     cross-reactive against multiple HIV-1 stains. Also, to determine whether boosting with the     vaccine orally or rectally will help induce mucosal antibody responses.      Induction of CD8+ CTL activity is considered a critical property for a candidate vaccine.     Additionally, since the majority of HIV-1 infections occur after inoculation of a mucosal     surface, it is desirable to induce mucosal immunity as well as systemic immunity. The HIV     p17/p24:Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against     HIV-1.   "
162062|NCT00001054|"     To obtain tolerance, safety, and pharmacokinetic data for oral valacyclovir hydrochloride (     256U87 ) in HIV-1 infected children with herpes simplex virus infections ( cold sores )     and/or varicella / zoster virus infections ( chicken pox / shingles ).      Varicella and zoster are common problems in HIV-infected children. It is believed that     chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir,     resulting in resistance to that drug. Valacyclovir hydrochloride, which converts to acyclovir     in the body, increases acyclovir bioavailability by 3-5 fold.   "
162063|NCT00001055|"     To evaluate the safety and immunogenicity of ALVAC-HIV MN120TMG (vCP205) in comparison to     ALVAC-RG rabies glycoprotein (vCP65) as a control when administered in HIV-1 negative     volunteers.      ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a     humoral and cellular response against several antigens. This recombinant construct is based     on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the     transmembrane portion of the LAI strain as well as gag and protease.   "
162064|NCT00001056|"     To determine the safety of and immune response to vaccinia-derived HIV-1 recombinant envelope     glycoprotein (gp160) at a dose of 200 mcg in human volunteers; to evaluate duration of     antibody response and its relationship to the dose and frequency of inoculation.      Although recent advances have been made in antiviral therapy against AIDS, there is currently     no cure for AIDS. It is likely that the ultimate control of the disease depends on the     development of safe and effective vaccines against HIV.   "
162065|NCT00001057|"     To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI)     on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected patients     with CD4 counts greater than or equal to 550 cells/mm3.      Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV     infection, there is an extraordinarily large number of infected CD4+ lymphocytes and     macrophages throughout the lymphoid system, both in latent and productive states. These     findings support the belief that early intervention therapy with reverse transcriptase     inhibitors could prolong the clinical latency period.   "
162066|NCT00001058|"     To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or     both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons     with AIDS, including individuals who have or have not received prior MAC prophylaxis.      It is believed that effective therapy for MAC disease in patients with AIDS requires     combinations of two or more antimycobacterial agents in order to overcome drug resistance and     the unfavorable influence of the profound immunosuppression associated with AIDS. Data     suggest that clarithromycin may have substantial activity in two- or three-drug combination     regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones.   "
162067|NCT00001059|"     To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone     or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related     Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free     survival and quality of life.      Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which     permits disease palliation at relatively low doses and thus decreases some of the     dose-limiting toxicity. Multi-agent therapy is considered to be more effective than     single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.   "
162068|NCT00001060|"     To determine the safety of immunization with HIV-1 C4-V3 polyvalent peptide vaccine in     HIV-infected persons. To determine the proportion of study participants immunized who develop     new specificities or increased levels of neutralizing and other antibody responses, T-cell     proliferative responses, and Class I restricted cytotoxic T-lymphocyte ( CTL ) responses.      HIV-1 C4-V3 polyvalent peptide vaccine contains amino acid sequences for selected epitopes     from four of the most common HIV isolates in the United States and Europe, predicted to     represent about 50-90 percent of the HIV isolates in the United States. It includes epitopes     that generate potentially salutary immune responses and deletes epitopes that generate immune     responses which might contribute to further immunopathogenesis.   "
162069|NCT00001061|"     To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on     time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of     MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL 109 and     efficacy and virologic markers.      Therapeutic agents currently available for CMV retinitis are limited by their inherent     toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL     109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations     easily maintained in AIDS patients.   "
162070|NCT00001062|"     To determine whether alternating oral ganciclovir with intravenous ( IV ) ganciclovir can     prevent relapse of Cytomegalovirus ( CMV ) retinitis and improve quality of life in AIDS     patients.      A systemic treatment strategy for CMV retinitis is needed that will be effective yet     convenient to administer, without the need for a permanent indwelling IV catheter. Although     oral ganciclovir has been used as maintenance following induction with IV ganciclovir,     patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which     oral and IV ganciclovir are alternated may prevent reactivation and progression of disease,     as opposed to the current therapeutic strategy in which changes in therapy are event-driven.     Also, the duration of intermittent IV therapy required to control disease may be short enough     to eliminate the need for an indwelling catheter.   "
162071|NCT00001063|"     To compare the effect of stavudine (d4T) alone or with zidovudine (AZT) versus didanosine     (ddI) alone or with AZT on CD4 counts, HIV RNA levels, and viral load in HIV-infected     patients [AS PER AMENDMENT 3/21/97: To compare the effects of d4T alone versus ddI alone     versus AZT plus ddI]. To compare the safety of d4T/AZT. AS PER AMENDMENT 3/21/97: To evaluate     the pharmacokinetic interactions of AZT and d4T both at an extracellular and intracellular     level.      Although AZT and ddI can delay the advancement of HIV disease, the benefit of either of these     drugs has proven to be only temporary. d4T, a new nucleoside analog with a favorable toxicity     profile and demonstrated activity against HIV, offers an additional therapeutic option. It is     reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical     disease progression is directly related to its ability to achieve and sustain viral     suppression; thus, this study measures effects on viral load and CD4 count.   "
162072|NCT00001064|"     To define the safety and efficacy of sibling-supplied, HIV antigen-pulsed dendritic cells in     increasing the immune response in HIV-infected patients.      Dendritic cells are a type of white blood cell used by the body to fight infection. They are     instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since     dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic     cells from an HIV-negative sibling may enable the affected sibling's immune system to     recognize foreign particles more readily and increase immune response against the virus.   "
162073|NCT00001065|"     To assess response and toxicity in patients with fluconazole-resistant oral candidiasis (     thrush ) when given initial induction with amphotericin B oral suspension.      Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected     patients is limited but encouraging.   "
162074|NCT00001066|"     To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the     better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected     children who received less than 56 days of prior antiretroviral therapy. To evaluate the     safety and tolerance of 3TC/AZT in this patient population. To determine other measures of     diseases in response to the study regimens.      Currently, none of the potential treatments for HIV-1 infection has proven to be both     nontoxic and effective in long-term use. However, previous studies in both adults and     children have shown that 3TC combined with AZT reduced HIV load in blood and increased white     blood cells. Additionally, 3TC has demonstrated a favorable safety profile.   "
162075|NCT00001067|"     To determine drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT     ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes     in magnitude of HIV RNA over time.      Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of     the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV     activity in previous studies, provides an additional therapeutic option.   "
162076|NCT00001068|"     To determine the influence of virus load, CD4 count, biologic phenotype, and presence of     symptomatic disease on the response of HIV-infected patients to a new therapeutic regimen.     PER AMENDMENT 8/27/96: To extend the availability of currently assigned ACTG 303 treatment     for 6 months.   "
162077|NCT00001069|"     PRIMARY: To compare the clinical efficacy of two decision making strategies for initiating or     changing antiretroviral therapy: decision making based on current clinical practice alone     (i.e., initiating or changing therapy based on CD4 count decline and/or clinical progression)     versus decision making based on plasma HIV RNA quantitation in addition to current clinical     practice.      SECONDARY: To evaluate toxicity, biological markers, and patient management in the two arms.      Although changing therapies is a common strategy in the treatment of HIV disease, guidelines     are needed to help clinicians and patients decide when a change in antiretroviral therapy is     indicated. The technology of measuring HIV RNA in plasma has been suggested as a tool for     monitoring clinical drug efficacy. However, uncertainty remains about whether aggressive     antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible     will confer clinical benefit in comparison with management based on monitoring CD4 counts and     HIV-related symptoms.   "
162078|NCT00001070|"     This is a study to evaluate the tolerance and antiviral effect of oral vitamin C in     HIV-infected.   "
162081|NCT00001073|"     The purpose of this study is to see if it is safe and effective to give isotretinoin to     HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous.      Cervical tumors are found in both HIV-infected and HIV-negative women. However, HIV-infected     women are at a greater risk, and often their tumors become cancerous more quickly than those     in HIV-negative women. Isotretinoin may be able to prevent this from happening. However,     since these tumors tend to disappear over time, many doctors are hesitant to give their     patients isotretinoin since this drug causes birth defects. This study looks at whether it is     better to treat cervical tumors in HIV-infected women or to wait and see if they will     disappear by themselves.   "
162082|NCT00001074|"     To determine the safety and tolerability of hydroxyurea at two doses alone and in combination     with didanosine (ddI). To compare the short term antiviral effect of ddI monotherapy versus     hydroxyurea plus ddI, as measured by plasma RNA levels at 8 weeks of therapy. [AS PER     AMENDMENT 10/1/97: Accrual to arms involving hydroxyurea alone has been closed.] Current     antiviral therapies for HIV-1 are limited by a few choices, and the lack of sustained     clinical benefit from the drugs. The mechanisms that account for the lack of prolonged     inhibition of viral replication by these agents are not fully understood. The activity of RT     inhibitors might be potentiated by inhibiting host cellular enzymes essential for efficient     HIV reverse transcription. Based on this information, comparisons of the antiviral effects of     ddI monotherapy and hydroxyurea plus ddI, with the cellular enzyme ribonucleotide reductase     as a potential target, should be done.   "
162083|NCT00001075|"     To determine whether administration of a highly active antiretroviral treatment regimen     consisting of ritonavir (ABT-538), zidovudine (AZT), and lamivudine (3TC) is associated with     the restoration of delayed type hypersensitivity and lymphocyte proliferative responses in     patients with moderately advanced HIV-1 infection. To better characterize in these patients     the phenotype of the expanded lymphocyte subpopulations, as well as the genotype, phenotype,     and cellular origin of viruses that persist after initiation of therapy, and the genotype and     phenotype of drug-resistant isolates that emerge during therapy.      Although plasma viral load drops dramatically after initiation of powerful antiretrovirals,     it does not drop to zero. It appears that a new steady state is reached, suggesting that a     reservoir may exist of virus-producing cells, possibly cells of monocyte/macrophage lineage,     that continue to produce a low level of virus despite antiretroviral treatment.   "
162084|NCT00001076|"     To evaluate the safety and immunogenicity of an accelerated schedule of recombinant canarypox     vaccine ALVAC-HIV MN120TMG (vCP205) versus control followed by boost with rgp120/HIV-1 SF2     vaccine in HIV-negative volunteers.      Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic     T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can     produce immunological responses comparable to those obtained in other trials of ALVAC-HIV     vCP205.   "
162085|NCT00001077|"     To compare a caloric supplement containing peptides and medium-chain triglycerides, a caloric     supplement containing whole protein and long-chain triglycerides, and no caloric supplement     for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and     mineral supplement.   "
162086|NCT00001078|"     The purpose of this study is to find out if it is safe for HIV-positive children who are     responding well to their anti-HIV treatment to stop taking medications that prevent     AIDS-related infections (opportunistic infections) such as pneumonia and other bacterial     infections. This is an observational study, meaning children will only be monitored to see if     they develop any infections.      Children have been receiving medications to prevent complications of HIV infection, such as     Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC) disease, or other     bacterial infections. It is common for HIV-positive patients with low CD4 counts to receive     these preventive medications. However, these drugs can have serious side effects, they are     expensive, and it is possible for bacteria resistant to the drugs to grow. For these reasons,     it may be beneficial to the child to stop taking these preventive medications if he/she has     been on anti-HIV (antiretroviral) therapy and has improved CD4 counts. This study will look     at how many children who stop taking their medications develop opportunistic infections.   "
162087|NCT00001079|"     To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM)     that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved     by treatment with megestrol acetate and testosterone enanthate in combination.      Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with     HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV     associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight     gain in subjects with cancer and in those with HIV associated weight loss. However, the     weight gained during treatment with megestrol acetate was predominantly or exclusively fat.     An important factor is the preferential increase in body fat seen in both of these studies     may have been due to hypogonadism that occurs as a result of treatment with megestrol     acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and     a decrease in LBM. Concomitant testosterone replacement should substantially increase the     amount of LBM accrued during megestrol acetate therapy. This study will determine whether     anabolic potential can be realized when caloric intake is increased in the absence of     concomitant hypogonadism.   "
162088|NCT00001080|"     To ascertain whether the origin of plasma HIV-1-RNA following T cell activation represents     the activation of latently infected cells or an increase in cells permissive for replacing     viral mutants.      The mechanism by which immune stimulation increases circulating levels of HIV-1 is not known.     In particular, it is uncertain whether the transient increase in plasma HIV-1 RNA is due to     enhanced replication of an actively replicating pool of HIV-1, or is due instead to     activation of proviral sequences in previously resting CD4+ cells. One approach to     discriminate these alternatives is a molecular pulse-chase experiment. In this approach,     drug resistant mutants would be selected by administration of Lamivudine (3TC).   "
162140|NCT00002010|"     The study is intended to examine the efficacy of fluconazole for the treatment of     coccidioidal meningitis in patients with new onset of infection, relapse of previous     infection, or failed previous therapy. Drug efficacy, safety and tolerance will be examined.   "
162141|NCT00002011|"     To determine the safety and patient tolerance of UVAR Photopheresis System (extracorporeal     photopheresis) in the Treatment of AIDS-Related Complex (ARC).   "
162089|NCT00001081|"     To determine the frequency of complete, marked, and partial clinical responses in patients     with cryptosporidiosis treated with 6 weeks of NTZ versus 21 days of placebo. To determine     the safety of NTZ in subjects with cryptosporidiosis.      There is no proven therapy for cryptosporidiosis in persons with AIDS. Nitazoxanide appears     to be a good candidate drug for further evaluation because of its effectiveness in     preclinical models, the data from early clinical trials and its safety profile. Cooperation     between clinical researchers and basic scientists in clinical trials of agents for HIV     infection and its complications is a high priority for the ACTG, the NIAID, and the NIH.     Thus, it is important to design a clinical trial of NTZ that includes cooperation with basic     scientists.   "
162090|NCT00001082|"     To evaluate the safety and efficacy of adefovir dipivoxil in prolonging survival of patients     with advanced HIV disease. In CMV prophylaxis substudy: To evaluate the efficacy of adefovir     dipivoxil in preventing the development of CMV end-organ disease in patients with advanced     HIV coinfected with CMV.      The optimal treatment for HIV infection and the prevention of CMV disease has not been     identified. Currently available antiretroviral therapies are hampered by both significant     toxicities and the development of resistance. In addition, agents for preventing CMV disease,     such as oral ganciclovir, are complicated by poor bioavailability and decreased compliance     secondary to toxicities. Moreover, discordant results have been reported regarding the     effectiveness of oral ganciclovir for preventing CMV disease. There is a need for newer     agents with anti-HIV and anti-herpesvirus activity that have good pharmacokinetic and safety     profiles and that will be well tolerated by patients. Adefovir dipivoxil is an oral pro-drug     of PMEA, a nucleoside analog with activity against a broad spectrum of retroviruses and     herpesviruses, including important human pathogens, such as HIV-1, HIV-2 and CMV. Due to its     anti-HIV and anti-herpesvirus activity, adefovir dipivoxil may be able to decrease the     incidence of opportunistic herpesvirus infections and prolong survival in patients with     advanced HIV infection.   "
162091|NCT00001083|"     For PRAM-1: To evaluate zidovudine (ZDV) + lamivudine (3TC) vs. stavudine (d4T) + ritonavir     vs. ZDV + 3TC + ritonavir with respect to the change in plasma HIV-1 RNA copy number from     baseline to 48 weeks [AS PER AMENDMENT 1/5/98: 72 weeks; AS PER AMENDMENT 7/17/98: 48 weeks]     in stable HIV-infected children with >= 16 weeks of prior continuous antiretroviral therapy.     To evaluate the safety and tolerance of ZDV + 3TC vs. d4T + ritonavir vs. ZDV + 3TC +     ritonavir based upon laboratory and clinical toxicities.      AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: To evaluate d4T + nevirapine + ritonavir with     respect to change in plasma HIV-1 RNA copy number from baseline to 48 weeks in children who     have received at least 12 weeks of therapy on the PRAM-1 ZDV/3TC arm and have over 10,000     viral copies at weeks 12, 24, or 36. To evaluate the safety and tolerance of d4T + nevirapine     + ritonavir based upon laboratory and clinical toxicities. [AS PER AMENDMENT 10/23/98: To     evaluate safety and tolerance of a switch from d4T + ritonavir vs. ZDV + 3TC + ritonavir to     d4T + indinavir vs. ZDV + 3TC + indinavir in stable, HIV-infected children with RNA values <=     10,000 copies/ml.] For PRAM-1: Evidence supports combination therapy with 2 or more antiviral     agents as beneficial in the long-term management of HIV. The possibility exists that     combination therapy may result in a synergistic or additive activity over a prolonged period     of time. Also hypothesized is that the development of resistance to individual agents will be     developed if viral replication is significantly decreased.      AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: Interim analysis at 12 weeks on PRAM-1     indicates that the proportion of children reaching undetectable RNA levels on the ZDV + 3TC     arm is significantly less than the other two arms. The protocol, therefore, has been modified     (Step 2) to permit children in the ZDV + 3TC arm with RNA copy number >= 10,000 the     opportunity to change to a novel therapeutic regimen (d4T + nevirapine + ritonavir).   "
162092|NCT00001084|"     To compare the proportion of patients who sustain suppression of plasma HIV RNA to     undetectable levels [AS PER AMENDMENT 09/19/97: below 200 copies/mL by Roche UltraSensitive     assay] among the 3 regimens during the maintenance phase.      The objective of antiretroviral therapy is to reduce HIV replication, preserve immunologic     function and delay the development of HIV-related complications. In patients administered     potent antiretroviral regimens, HIV RNA levels are reduced below 500 copies/ml of plasma and     below the level of detection of commercially available assays. This protocol attempts to     learn if a less intensive regimen can successfully sustain viral suppression after induction     with a triple-drug regimen. The study also addresses whether HIV can be eradicated in     patients following prolonged treatment with induction and maintenance regimens.   "
162093|NCT00001085|"     To determine the proportion of patients whose plasma HIV-1 RNA level remains below a     detectable level (less than 500/ml) after 24 weeks of study therapy with either 141W94     monotherapy or 141W94 plus zidovudine (ZDV) and lamivudine (3TC). To determine the safety and     tolerability of 141W94 monotherapy and the combination of 141W94 plus 3TC in patients with     HIV infection.      Although dramatic inhibition of HIV-1 replication is achieved with ritonavir or indinavir     monotherapy, in both cases maximum suppression required combination treatment together with     nucleoside analog RT inhibitors. This study tests the hypothesis that monotherapy with 141W94     doses that result in Cmin levels far in excess of the IC90 corrected for plasma protein     binding for HIV-1 can achieve the same virologic and immunologic effects in terms of     magnitude and durability, as has been observed with combinations of other protease inhibitors     plus nucleoside analogs.   "
162094|NCT00001086|"     To compare the virologic response between abacavir (ABC, 1592U89) regimens (drug vs. placebo)     and between the 2 dosing regimens (BID vs. TID) with respect to the proportion of patients     with plasma HIV RNA levels below the limit of detection [AS PER AMENDMENT 8/27/97: < 500     copies/ml at week 16]. To evaluate the safety and tolerance of the study arms. [AS PER     AMENDMENT 3/10/99: During the extension period, compare the time to detectable viremia (2     consecutive plasma HIV RNA levels greater than or equal to 500 copies/ml) between ABC and     placebo.] Therapeutically, there is a need to explore potent alternative therapy for patients     who have received, or are currently receiving, a double nucleoside analog combination     including lamivudine (3TC), a regimen that was proven to be clinically inferior to indinavir     (IDV) when combined with zidovudine/3TC in study ACTG 320. In order to produce and maintain a     maximal antiviral response, all patients in this study will receive 2 or 3 potent, new     agents; ABC, a nucleoside analog, EFV, a non-nucleoside reverse transcriptase inhibitor     (NNRTI), and IDV, a protease inhibitor. Virologically, the major question this protocol seeks     to answer is how prior 3TC exposure in a dual nucleoside regimen influences the response to     subsequent treatment. It is unclear whether it is best to add a protease inhibitor either 1)     an NNRTI at 1 of 2 doses, or 2) an NNRTI at 1 of 2 doses plus a new nucleoside analog to     achieve plasma HIV RNA levels that are below the limits of detection.   "
162142|NCT00002012|"     To conduct a parallel-group, double-blind, randomized, placebo-controlled study to evaluate     the safety and efficacy of an orally administered low dose interferon alfa-n3 as an     immunomodulator in the treatment of mild to moderate symptomatic HIV+, AIDS-related complex     (ARC) patients.   "
162143|NCT00002013|"     To evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for     three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS     related complex (ARC).   "
162095|NCT00001087|"     Steps I and II: The purpose of this study is the following: To look at how many patients     achieve undetectable HIV blood levels at Week 16. To look at the absolute change in HIV blood     levels from the beginning of the study to Week 16. To look at the safety and tolerability of     nelfinavir (NFV) and efavirenz (EFV) when used in combination or separately in regimens     containing reverse transcriptase inhibitors (RTIs). For the 2 extension studies (Weeks 49 to     144): To look at the proportion of patients whose long-term viral load remains undetectable     at Week 96. To look at the time from the beginning of the study to treatment failure, with     patients evaluated through Week 144. Step III: To look at the proportion of patients whose     HIV blood levels are undetectable 16 weeks after starting the salvage study treatment. To     assess safety, toxicity, and tolerance of salvage study drug treatment. (This study has been     changed by adding new objectives.) Achieving viral suppression has been widely endorsed as     the primary goal of HIV therapy. However, there are few established guidelines for devising     combinations of different classes of drugs which will enhance the potential for achieving     viral suppression, reducing the risk of toxicity, and preserving therapeutic options for     future use. This study includes 2 anti-HIV drugs, NFV (a protease inhibitor [PI]) and EFV (a     nonnucleoside reverse transcriptase inhibitor [NNRTI]), for use either alone or in     combination with RTI therapy for the purpose of limiting HIV replication. Patients with     treatment failure at Week 16 choose 1 of the following 3 alternative salvage therapies:     2-drug PI regimen (saquinavir and ritonavir) plus adefovir dipivoxil and L-carnitine; EFV or     NFV (if not already given) plus 2 new approved anti-HIV drugs outside the study; or the best     available treatment outside the study. The new RTI, adefovir dipivoxil, is added to the     2-drug PI regimen to achieve suppression of viral replication and thereby delay disease     progression. (This rationale reflects a change in the treatment given to patients with     treatment failure at Week 16.)   "
162096|NCT00001088|"     To evaluate the safety, tolerability and immunogenicity in humans of the APL-400-047 vaccine     when administered intramuscularly by needle and syringe at 1 of 3 doses or by Biojector at     the intermediate dose. [AS PER AMENDMENT 07/98: To evaluate the tolerability, safety, and     immunogenicity of an increased dose in an additional group of volunteers.] DNA-based     immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and     cellular arms of the immune system; thus, potentially providing the advantages of a live     virus vaccination but without the potential risks. It is essential that novel vaccine     strategies (including DNA-based immunizations) continue to be developed and enter Phase I     human testing because to date, no candidate vaccine from any of the approximately 30 AVEG     Phase I or II trials has progressed to a Phase III efficacy trial. Use of a Biojector jet gun     for vaccine delivery may also have potential psychological, comfort, safety and immunologic     advantages over the traditional needle and syringe method of delivery.   "
162097|NCT00001089|"     To define relationships between 1) HIV load and risk of CMV disease, 2) CMV load and the risk     of developing CMV disease, and 3) CMV load and HIV load. To establish threshold CMV and HIV     load values in peripheral blood fractions that are associated with development of CMV     end-organ disease. To define the natural history of CMV diseases in the context of highly     active antiretroviral therapy (HAART).      Establishment of threshold CMV and HIV load values associated with CMV disease would     facilitate identification of HIV-infected individuals truly at risk for CMV disease in whom     targeted prophylactic interventions to prevent CMV disease would be indicated. These studies     would also further the understanding of the natural history of CMV disease within the context     of AIDS. Natural history studies conducted prior to the advent of highly active     antiretroviral therapy (HAART; i.e., 3-drug regimens that include HIV reverse transcriptase     and protease inhibitors) have demonstrated that the risk for developing CMV disease increases     with progression of HIV disease and with declining CD4 counts. Presently the need exists to     define the natural history of CMV disease in patients with AIDS within the context of HAART.   "
162098|NCT00001090|"     To evaluate the safety and immunogenicity of live recombinant canarypox ALVAC-HIV vCP205 in     combination with recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF)     at 80 microg and 250 microg. [AS PER AMENDMENT 4/30/99: To study the safety of following 4     ALVAC immunizations with a nucleic acid gag/pol HIV-1 immunogen (APL-400-047, Wyeth-Lederle).     To assess the ability of this sequence of immunization to boost the LTL, T-helper cell, and     antibody response.] ALVAC-HIV candidate vaccines have induced HIV-specific CTL responses in     more than half of recipients in some protocols. Depending on the HIV-1 gene products     expressed by the particular ALVAC-HIV candidate vaccine, volunteers have generated     anti-Envelope (vCP125, vCP205, and vCP300), anti-Gag (vCP205 and vCP300), and anti-Nef     (vCP300) CTL activity. Although 3 to 4 immunizations with the different ALVAC-HIV     experimental vaccines induce anti-HIV-1 neutralizing antibodies in a portion, often the     majority, of volunteers, the geometric mean titers of these antibodies are modest, usually     less than 50. This study will determine whether there is an increase in the anti-HIV antibody     titers when GM-CSF is used as an adjuvant with ALVAC-HIV vCP205 and will also examine the     kinetics and magnitude of the HIV-specific CTL response.   "
162099|NCT00001091|"     The purpose of this study is to see if it is safe and effective to give HIV-infected children     and teens 1 of 4 anti-HIV drug combinations.      Decreasing HIV levels in infected patients can slow down disease progression. Further study     is needed to find out which drug combinations are most effective in doing this.   "
162100|NCT00001092|"     The purpose of this study is to look at the amount of HIV in the blood, genital fluid, and     saliva of the partners of patients with early HIV infection. This study will also look at the     strength of the immune systems of patients with early HIV infection.      Because HIV multiplies very quickly in the early stages of infection, patients with early HIV     infection may be more likely to transmit HIV to their partners. The amount of HIV in blood,     genital fluid, and saliva may determine the risk for transmission.   "
162101|NCT00001093|"     The purpose of this study is to find out if it is effective to give aggressive anti-HIV     therapy to patients who have been infected recently with HIV.      Many doctors recommend that patients who have recently been infected with HIV begin anti-HIV     treatment as soon as possible. However, early HIV infection is not yet completely understood,     so it is not known if this is the best approach. This study will look at the effects of     beginning anti-HIV treatment during early HIV infection.   "
162116|NCT00001627|"     This study is designed to provide bone marrow and/or blood cells for other research studies.     Patients participating in this study will be asked to provide small amounts of medical     information and undergo a limited physical examination designed to detect the presence of any     obvious blood disease. A blood and bone marrow sample will be obtained to verify that the     patient has normal blood cell production.      Researchers plan to obtain bone marrow samples to be used in laboratory studies directed     toward understanding the formation of blood cells. Bone marrow samples will be taken from the     hip bone of patients and healthy volunteers.      These samples are valuable to many research studies within the Hematology Branch of the     National Heart, Lung, and Blood Institute, including studies of normal and abnormal     production of blood cells, the viral causes of blood diseases, and the role of the immune     system in bone marrow failure and related conditions.   "
162102|NCT00001094|"     To compare the long-term virologic response to combination therapy with two protease     inhibitors, i.e., nelfinavir (NFV) + saquinavir soft gel capsule (SQVsgc) and delavirdine     (DLV) or combination lamivudine/zidovudine (3TC/ZDV, Combivir) versus NFV and 3TC/ZDV, in the     proportion of patients demonstrating virologic success (< 500 copies/ml HIV RNA) at week 48,     without prior virologic or clinical failure. To evaluate the safety and tolerance of     combination protease inhibitors.      To evaluate the durability of virologic response as assessed by the Roche Ultra Sensitive     assay (< 200 copies/ml) and culturable virus. To compare time to a confirmed virologic     response (two consecutive plasma HIV RNA levels < 500 copies/ml) or to a confirmed treatment     relapse following a confirmed virologic response across the treatment arms. To evaluate     biologic phenotype (non-syncytium inducing versus syncytium inducing capacity) and the     evolution and patterns of viral resistance among patients with confirmed treatment failures     at or after weeks 16 to 24. To compare immunologic benefits, as measured by longitudinal     CD4/CD8 cell count profiles. To evaluate the influence of baseline virologic and immunologic     parameters on the magnitude and duration of plasma HIV RNA response. To compare virologic     response between the two dose schedules of NFV and SQVsgc (bid vs tid) and between NFV and     SQVsgc with either DLV or combination 3TC/ZDV. To evaluate compliance and exploratory     population pharmacometrics.      Past studies have shown that combination therapies not only will result in better clinical     outcomes but may prolong the effects of therapy. The enhanced effects seen with combination     therapies are likely related to a greater suppression of HIV replication and alterations in     resistance patterns. Both in vitro and in vivo studies suggest that triple-drug therapy may     have an advantage over one- and two-drug regimens. Therefore, triple-drug therapy appears to     be an important strategy in the treatment of HIV infection.   "
162103|NCT00001095|"     To determine the proportion of patients treated with amprenavir, zidovudine (ZDV), stavudine     (D4T) and lamivudine (3TC) whose HIV-1 RNA level remains below the level of detection during     96 weeks of therapy. To determine the proportion of patients treated with indinavir (IDV),     nevirapine (NVP), 3TC, and d4T whose HIV-1 RNA level decreases and then remains below the     level of detection, during the 96-week therapy period. To determine the viral effects,     safety, tolerability, and pharmacokinetics of amprenavir in combination with zidovudine,     stavudine, and lamivudine. [AS PER AMENDMENT 2/27/98: To determine the proportion of patients     with undetectable plasma HIV RNA, by treatment and baseline RNA cohort (either detectable or     undetectable). To determine the durability of these regimens by estimating the distribution     of time to loss of virologic suppression (or equivalently, time to virologic failure), by     treatment and baseline RNA cohort.] This study allows patients who have successfully     participated in ACTG 347 or other trials involving amprenavir to continue treatment with     amprenavir, ZDV, d4T, and 3TC. Additionally, this study provides patients whose HIV-1 RNA was     not reduced to undetectable levels or who had a significant increase in plasma levels     (treatment failures) the opportunity to change to a potentially more active regimen that     includes indinavir, nevirapine, lamivudine, and stavudine.   "
162104|NCT00001096|"     To assess the safety and immune response to two experimental vaccines when formulated with     QS-21 or QS-21 plus alum. To determine whether the new preparation of QS-21 in polysorbate 80     is less reactogenic than the QS-21 formulation used in AVEG Protocols 016, 016A, and 016B. To     examine whether QS-21 is immunologically equivalent to that used in 16B. To determine if     QS-21, when given with low doses of antigen, induces measurable HIV-1-specific CTL activity.     To evaluate if the QS-21 dose-sparing effect extends to an antigen dose of 0.5 micrograms. To     determine if the bivalent vaccine gives responses equivalent to the monovalent product or if     a broadening of the HIV-1-specific binding and neutralizing antibody responses occurs.      An effective vaccine to prevent HIV-1 infection may need to generate diverse and multifaceted     immunologic responses. Required parts of the immune response may include: humoral antibodies,     which broadly neutralize non-syncytium-inducing strains of HIV-1; T cell help provided by     both CD4 and CD8 positive subsets; and a class I-restricted cytotoxic lymphocyte response.     Other effector responses, such as the generation of antibody-dependent cellular cytotoxicity,     cytokines, chemokines, or other antiviral factors may also be critical in mounting protective     immunity. Given the lack of a surrogate immunologic marker, the most practical approach for     possible efficacy trials would be to evaluate a candidate vaccine that elicits as many of     these responses as possible.   "
162105|NCT00001097|"     The purpose of this study is to see if children and young adults with better immune systems     before starting highly active antiretroviral therapy (HAART) do better than those who have     weaker immune systems before starting HAART.      HIV infection weakens the immune system's ability to fight other infections and diseases.     HAART is a type of anti-HIV therapy shown to improve the immune system of adults. However,     not all patients show the same amount of improvement with HAART. Doctors believe that results     may depend on how strong a patient's immune system is before starting HAART. Long-term     effects of HAART in children and young adults have not yet been studied.   "
162106|NCT00001100|"     The purpose of this study is to evaluate the benefits and safety of the antiviral drug     ganciclovir (DHPG) given intravenously to treat newborn infants who are born infected with     cytomegalovirus (CMV). CMV is a herpes virus that can infect most organs of the body,     resulting in death in 10-30% of babies with symptoms of CMV. It can cause severe brain damage     in a large percentage of surviving babies. Children in this study have a CMV infection of the     central nervous system (CNS).   "
162107|NCT00001101|"     Lyme disease is the most common tick-borne disease in the United States. It is caused by the     spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1)     active infection by B. burgdorferi; 2) damage caused by the original infectious process; or     3) the presence of co-infection with another organism transmitted by Ixodes ticks. The     purpose of this study is to determine the safety and effectiveness, for seropositive     patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease     (CLD).   "
162108|NCT00001102|"     The purpose of this study is to see how taking certain anti-HIV drugs affects the way the     body metabolizes fat. This study will evaluate patients who are enrolled in CPCRA 058 (the     FIRST [Flexible Initial Retrovirus Suppressive Therapies] study) by looking for changes in     cholesterol levels, levels of fat in the blood, and body fat distribution. Patients in the     FIRST study receive an anti-HIV drug regimen which contains a protease inhibitor (PI), a     nonnucleoside reverse transcriptase inhibitor (NNRTI), or both.      Anti-HIV drug therapy using PIs has become very common treatment for HIV-positive patients.     Recently, however, serious side effects involving how the body uses fat are being reported in     patients taking PIs. Examples of these side effects are a redistribution of body fat, high     cholesterol level, and development of diabetes. However, some of these side effects have also     been seen in patients who are not taking PIs. It is important to determine whether or not     these side effects are directly related to PI use. In this study, patients on different drug     combinations, either with or without a PI, will be compared.   "
162257|NCT00002127|"     To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of     thalidomide in reducing weight loss in patients with HIV wasting syndrome.   "
162110|NCT00001104|"     Study A: To determine whether treatment with zidovudine (ZDV) will delay or change the     disease process in hemophilic patients who have HIV infection with no symptoms. The major     clinical question is whether patients who receive chronic ZDV therapy will have a delay in     the development of AIDS or AIDS-related complex (ARC). The pharmacokinetics (blood levels) of     ZDV in hemophilic patients will also be studied.      Study B: To determine if ZDV therapy changes the risk of a hemophiliac transmitting HIV to     his wife or other female sexual partner. To determine the effectiveness of counseling and     education on the behaviors of the wives that place them at risk for HIV infection. To     determine if antibodies to HIV either appear or disappear from the blood of any of the wives     during the study.      Study A: Individuals who are infected with HIV can benefit from therapy with an effective     anti-AIDS virus agent. ZDV is a potent inhibitor of HIV in vitro (test tube) and is safe in     humans at the dose planned. It may be effective in preventing the development of AIDS or ARC     in hemophiliacs who have the HIV antibody in their blood. The pharmacokinetic studies are     especially important because the high prevalence of hepatic disease in this population may     affect the metabolism and blood levels of ZDV.      Study B: HIV is transmitted by sexual contact, and wives of infected hemophilic patients have     become infected during long-term sexual relationships. Transmission of the virus does not     occur during casual family contact. This study will aid in determining if therapy influences     the transmission of HIV, because the wives of hemophiliacs generally have no risk for HIV     infection other than sexual contact with their spouse.   "
162111|NCT00001105|"     To determine the safety and pharmacokinetics of F105 human monoclonal antibody both following     a single dose and during intermittent administration in HIV-infected patients. To determine     specific dose concentrations sufficient to achieve efficacy and avoid toxicity. To determine     the effect of F105 on virologic, immunologic, and serologic parameters.      Early in the course of HIV infection, the primary humoral immune response appears to be     highly strain specific and to be directed at a hypervariable portion of the viral gp120. The     F105 human monoclonal antibody reacts with the CD4 binding region of gp120 and has been shown     to neutralize the IIIB, SF2, and MN strains of HIV at concentrations readily achievable in     humans.   "
162112|NCT00001623|"     Bone marrow transplants (BMT) are one of the accepted therapies used to treat leukemia.     However, BMT have risks of complications. One potentially life-threatening complication is     known as graft-versus-host disease (GVHD).      The GVHD is a reaction caused by an incompatibility between donor cells and recipient cells.     Antigens found on the recipient s cells are recognized by the donor s transplanted white     blood cell lymphocytes. These lymphocytes begin attacking the recipient s cells and tissues     and may lead to death.      One of the most effective ways to prevent this reaction is to remove the lymphocytes from the     transplanted marrow. Unfortunately, without lymphocytes the recipient s immune system will be     lowered and may result in a relapse of leukemia or an infection.      Researchers have shown they can perform effective BMT by removing the lymphocytes prior to     the transplant and then later adding the lymphocytes back. This technique can reduce the     potential for GVHD and preserve the graft-versus-leukemia (GVL) effect of the transplant.      In this study researchers plan to use peripheral blood with lymphocytes removed rather than     bone marrow. In order to increase the number of progenitor cells, the cells responsible for     correcting the leukemia, donors will receive doses of G-CSF prior to the transplant. G-CSF     (granulocyte colony stimulating factor) is a growth factor that increases the production of     progenitor cells in the donor s blood stream.      The study will be broken into two parts. The first part of the study will attempt to     determine if peripheral blood with lymphocytes removed can prevent GVHD while preserving the     GVL effect of the transplant.      In the second part of the study, patients that received the transplant will have the     lymphocytes added-back on two separate occasions in order reduce the chances of relapse and     infection.      The study is designed to treat up to 55 patients ages 10 to 60 years and follow their     progress for 5 years.   "
162113|NCT00001624|"     Previous studies have shown that insulin may stimulate the release of endothelin (ET) from     endothelial cells. This mechanism may contribute to the adverse vascular effects determined     by chronic hyperinsulinemia. The aim of this study will be to evaluate the effect of local     hyperinsulinemia on ET activity in the forearm circulation. To this purpose, we will assess     the forearm blood flow response to ET receptor antagonism in control conditions and during     intraarterial infusion of insulin. We will also measure changes in plasma ET-1 levels in     response to the different pharmacological stimuli.   "
162114|NCT00001625|"     Patients with high blood pressure, diabetes, and who are overweight are known to have defects     in the way their body responds to insulin. The purpose of this study is to develop better     methods for measuring the way body tissue responds to insulin and sugar (glucose).      Researchers are planning to study four groups of patients.        1. Normal volunteers        2. Patients who have mild to moderate high blood pressure        3. Patients who are overweight        4. Patients who have mild to moderate diabetes controlled with oral medication      In this study patients and volunteers will undergo two separate tests designed to determine     how well insulin is working in the body. The first test is called a glucose clamp test.     Patients will have two needles placed in the veins of their arms. One needle will be used to     take blood samples, the other needle will be used to inject doses of sugar (glucose) and     insulin.      The second test is called the frequently sample intravenous glucose tolerance test. In this     test patients will have sugar (glucose) injected into their veins followed by a slow injected     dose (infusion) of insulin. Researchers will periodically take blood samples during the test.      Patients participating in the study will not directly benefit from it. However, the     information gained from this study may be useful for improving the diagnosis and therapy of     diseases such as diabetes, obesity, and high blood pressure (hypertension).   "
162115|NCT00001626|"     Severe Aplastic Anemia (SAA) is a rare and very serious blood disorder in which the bone     marrow stops producing the cells which make up blood; red blood cells, white blood cells, and     platelets.      Researchers believe this is caused by an autoimmune reaction, a condition in which the     natural defense system of the body begins attacking itself. In SAA the immune system begins     attacking the bone marrow. Red blood cells are responsible for carrying oxygen to all of the     organ systems in the body, and low numbers (anemia) can cause difficulty breathing and     fatigue. Platelets are responsible for normal blood clotting and low numbers can result in     easy bruising and bleeding which can be deadly. White blood cells are responsible for     fighting infections, and low numbers of these can lead to frequent infections, the most     common cause of death in patients with aplastic anemia.      SAA can be treated by bone marrow transplant (BMT) or by drugs designed to slow down the     immune system (immunosuppressants). BMT can be successful, but it requires a donor with     matched bone marrow, making this therapy available only to a few patients. BMT with unmatched     bone marrow can fail and cause dangerous side effects.      Presently, the two drugs used to treat SAA by slowing down the immune system     (immunosuppression) are antithymocyte globulin (ATG) and cyclosporin A (CSA). When used in     combination these two drugs can improve most patients condition. However, one third of the     patients who respond to this therapy experience a relapse of SAA. In addition, some patients     treated with ATG/CSA can later develop other disorders of the blood.      Recently, researchers have found that another immunosuppressive drug called cyclophosphamide,     has been successful at treating patients with SAA. In addition, patients treated with     cyclophosphamide do not experience relapses or develop other disorders of the blood.      In this study researchers would like to compare the combinations of antithymocyte globulin     (ATG) and cyclosporin A (CSA) to cyclophosphamide and cyclosporin A (CSA) for the treatment     of SAA.   "
162144|NCT00002014|"     To determine the safety and tolerance of various combinations of zidovudine (AZT) and     didanosine (ddI) administered concurrently. To determine the pharmacokinetics of concurrent     AZT and ddI administered orally. To evaluate the antiviral, immunologic and virologic effects     of AZT and ddI administered concurrently.   "
162117|NCT00001628|"     The renin angiotensin system (RAS) plays an important physiological and pathophysiological     role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in     the treatment of hypertension, cardiac failure and in some patients with myocardial     infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors     (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the     mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce     angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in     the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and     the vascular endothelium indicate that ACEI improve peripheral endothelial function, an     effect that is partially mediated by bradykinin. The current protocol is designed to     investigate whether the beneficial effects of ACEI on peripheral endothelial function are     also due to inhibition of angiotensin II. The recent development of selective angiotensin II     type 1 (AT1) receptor antagonists allows us to specifically examine the effects of     angiotensin II on vasomotor activity.   "
162118|NCT00001629|"     The renin angiotensin system (RAS) plays an important physiological and pathophysiological     role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in     the treatment of hypertension, cardiac failure and in some patients with myocardial     infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors     (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the     mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce     angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in     the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and     the vascular endothelium indicate that ACEI improve both endothelial dysfunction and     metabolic coronary vasodilation, an effect that is partially mediated by bradykinin. The     current protocol is designed to investigate whether the beneficial effects of ACEI on     endothelial function are also partly due to inhibition of angiotensin II. The recent     development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to     specifically examine the effects of angiotensin II on vasomotor activity.   "
162119|NCT00001630|"     Platelets are particles found along with red and white blood cells in the blood that play a     role in the process of blood clotting. Disorders affecting the platelets can lower the amount     of platelets in the blood and put patients at risk of bleeding. The condition of low     platelets is referred to as thrombocytopenia.      Thrombocytopenia can be associated with a variety of diseases including cancer, leukemia,     tuberculosis, or as a result of an autoimmune reaction. Autoimmune reactions are disorders in     which the normal immune system begins attacking itself. Autoimmune thrombocytopenia (AITP) is     a disorder of low blood platelet counts in which platelets are destroyed by antibodies     produced by the immune system.      Unfortunately, many patients with AITP do not respond to standard treatments for     thrombocytopenia. Cyclophosphamide is a drug that works to suppress the activity of the     immune system. Researchers believe that combining this drug with transplanted rescued blood     stem cells may provide effective treatment for AITP.      The purpose of this study is to explore the affordability and safety of this therapy for the     treatment of AITP. The effectiveness of the therapy will be measured by the number of     patients whose platelet levels rise greater than 100,000/m3.      If this treatment approach appears affordable, this study will form the basis for a larger     study to compare alternate treatment approaches.   "
162120|NCT00001631|"     Blood flows to areas of the heart providing oxygen and fuel to the pumping muscle.     Occasionally the arteries providing the fuel can become blocked. This occurs in coronary     artery disease.      Magnetic resonance imaging (MRI) can be used to evaluate the blood flow to different areas of     the heart muscle. In this study magnetic resonance imaging will be compared to other     diagnostic tests (radionucleotide perfusion studies) capable of measuring blood flow to heart     muscle.   "
162121|NCT00001632|"     The human heart is divided into four chambers. One of the four chambers, the left ventricle,     is the chamber mainly responsible for pumping blood out of the heart into the circulation.     Hypertrophic cardiomyopathy is a genetically inherited disease causing an abnormal thickening     of heart muscle, especially the muscle making up the left ventricle. When the left ventricle     becomes abnormally large, it is called left ventricular hypertrophy (LVH).      Patients with HCM can be born with an enlarged left ventricle or they may develop the     condition in childhood or adolescence, usually during the time when the body is rapidly     growing. However, not all patients with the abnormal genes linked to HCM have the     characteristic LVH.      Currently, it is impossible to tell if a patient with the genes for HCM will develop LVH.      A recently developed ultrasound tool called an integrated backscatter analysis (IBS), may     allow researchers to determine those children who may later develop HCM and LVH. In order to     test this, researchers plan to use IBS to study normal children with relatives diagnosed with     HCM.      This study will compare the results of IBS done on normal children with relatives diagnosed     with HCM , normal children, and children with evidence enlarged heart muscle (HCM).   "
162122|NCT00001633|"     Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the     human body without the use of X-ray (radiation). MRI is especially useful when studying the     arteries of the heart (CMRA, coronary magnetic resonance angiography).      In this study researchers from several laboratories and hospitals will work together to     determine the safety and effectiveness of CMRA with MS-325. MS-325 is a contrast agent. It is     given to patients undergoing CRMA in order to improve the appearance of the arteries of the     heart.   "
162123|NCT00001637|"     Diseases such as leukemia, lymphoma, and multiple myeloma fall into the category of blood     cancers. Some of these conditions can now be cured by bone marrow transplantation (BMT). The     ability of BMT to cure these conditions has been credited to the use of high doses of     chemotherapy, radiation therapy, and the antileukemia effect of the transplant.      Because the effectiveness of BMT relies on the use of high doses of chemotherapy and total     body irradiation (TBI), it is a therapy associated with toxic side effects. These side     effects are often deadly and have limited BMT for use in patients under the age of 55.      In this study researchers plan to treat older patients between the ages of 55 to 75 years     with blood cell transplants taken from donors who are genetically matched relatives of the     patient. In order to decrease the toxic side effects associated with the transplant,     researchers will not use chemoradiotherapy. Instead they plan to use intensive     immunosuppressive therapy and allow the transplanted cells to take effect.   "
162125|NCT00001639|"     The purpose of this research is to study a new way to test for chromosome abnormalities.     Chromosomes are strands of DNA (the genetic material in the cell nucleus) that are made up of     genes-the units of heredity. Chromosome abnormalities are usually investigated by staining     the chromosomes with a dye (Giemsa stain) and examining them under a microscope. This method     can detect many duplications and deletions of pieces of chromosomes and is very accurate in     diagnosing certain abnormalities. It is not useful, however, for identifying very small     abnormalities. This study will evaluate the accuracy of a test method using 24 different dyes     for finding small chromosome abnormalities.      Children and adults with various chromosome abnormalities may be eligible for this study,     including, for example, people with developmental delay or mental retardation, abnormal     growth features or growth retardation, and certain behavioral disorders. Participants will be     evaluated in the clinic over a 1- to 3-day period, depending on their symptoms. All     participants will be examined by a genetics specialist and will have a physical examination     and possibly X-rays, computerized tomography (CT) scans, magnetic resonance imaging (MRI),     ultrasound studies and medical photography. Blood will be drawn for chromosome testing-about     3 tablespoons from adults and 1 to 3 teaspoons from children.      When the test results are available, participants will return to the clinic for follow-up     evaluation and review of the test findings. The genetic and medical evaluations, along with     their implications, will be discussed.   "
162126|NCT00001640|"     The purposes of this study are to identify the gene or genes responsible for an inherited     form of Parkinson's disease and learn more about how the disease develops.      In Parkinson's disease, a deficiency of a brain chemical called dopamine impairs the function     of the part of the brain that controls movement. As a result, patients may have difficulty     moving or they may have uncontrolled movements of their hands and fingers. Parkinson's     disease usually occurs sporadically, with no known cause. In a few families, however, the     disease seems to be inherited through a gene mutation (change). There is a 50-50 chance that     a parent with the mutated gene will pass it on to a child. Children who do inherit the     abnormal gene may or may not go on to actually develop Parkinson's disease-the relative     chance of this happening is not known.      Individuals 18 years of age and older from families in which Parkinson's disease appears to     be inherited may be eligible for this study. Participants will have a brief medical     examination, provide a personal and family medical history, and have a small blood sample (2     tablespoons) taken for genetic studies. The total time required for the study is about 1 to 2     hours.      Participants are encouraged to meet with a NIH investigator or with a genetics specialist in     their local area before testing to talk about the possible implications for themselves and     their families of the test results....   "
162127|NCT00001641|"     The purposes of this study are to identify the genes responsible for inherited connective     tissue disorders and learn about the range of medical problems they cause. It will     investigate whether specific gene changes cause specific medical problems and will establish     diagnostic criteria (signs and symptoms) for the individual syndromes.      Children and adults with a known or suspected inherited connective tissue disorder (Marfan,     Ehlers-Danlos or Stickler syndrome, or other closely related disorders) and their family     members may be eligible for this study.      Patients enrolled in the study will have a medical history, physical examination and blood     tests, as well as other procedures that may include:        -  Echocardiogram (ultrasound of the heart)        -  X-rays and other imaging studies, such as magnetic resonance imaging (MRI) or          computerized tomography (CT) scans        -  Lung function studies        -  Urine tests        -  Skin biopsy (removal of a small piece of tissue, under local anesthetic, for microscopic          examination)        -  Examination by various specialists (e.g., in ophthalmology, gastroenterology,          rehabilitation medicine) as needed        -  Questionnaires regarding chronic pain and fatigue, quality of life, and the impact of          the connective tissue disorder on the patient and family.      (Patients who wish to enroll but cannot travel to NIH may have a more limited participation,     including review of medical records, telephone interview regarding personal and family     history, and collection of a specimen (blood, skin biopsy, or other) for genetic testing.      Patients will be notified of genetic testing results that show a change responsible for their     connective tissue disorder. If they wish, the information will also be sent to their local     health care provider, along with recommendations for additional tests or treatment options.     No treatment is offered as part of this study.      Participating family members who do not themselves have a connective tissue disorder will     provide a small blood sample for gene testing and be interviewed by telephone about their     personal and family health history. Those whose blood test results show a gene change     associated with a connective tissue disorder will be invited to NIH for a discussion of the     findings or referred to a genetic center in their area.   "
162128|NCT00001642|"     The goal of the project is to identify and clone the gene(s) responsible for the Alagille     Syndrome (AGS) by a positional cloning approach. The first step towards this goal is to     define the smallest genomic candidate region for AGS at 20p12 and to begin to identify genes     within this region which are, by definition, candidate genes for the disease. In a     collaborative effort with clinician-investigators studying the Alagille syndrome, metaphase     chromosomes and genomic DNA from affected individuals will be studied for subchromosomal     deletions and for mutations in the candidate genes. Characterization of genes involved in     Alagille syndrome could provide important insight into the pathophysiology of the disease,     the development of normal liver and treatment of this disease. Recently, we and others found     that mutations in Jagged1, a Notch1 receptor are responsible for Alagille Syndrome.   "
162129|NCT00001643|"     The purposes of this study are to identify the gene or genes responsible for an inherited     form of Parkinson's disease and learn more about how the disease develops.      In Parkinson's disease, a deficiency of a brain chemical called dopamine impairs the function     of the part of the brain that controls movement. As a result, patients may have difficulty     moving or they may have uncontrolled movements of their hands and fingers. Parkinson's     disease usually occurs sporadically, with no known cause. In a few families, however, the     disease seems to be inherited through a gene mutation (change). There is a 50-50 chance that     a parent with the mutated gene will pass it on to a child. Children who do inherit the     abnormal gene may or may not go on to actually develop Parkinson's disease-the relative     chance of this happening is not known.      Individuals 18 years of age and older from families in which Parkinson's disease appears to     be inherited may be eligible for this study. Participants will have their medical records     reviewed, provide a personal and family medical history (by telephone or in person), and have     a small blood sample (2 tablespoons) taken for genetic studies. The total time required for     the study is about 1 to 2 hours.      Participants are encouraged to meet with a NIH investigator or with a genetics specialist in     their local area before testing to talk about the possible implications for themselves and     their families of the test results....   "
162145|NCT00002015|"     To evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12     years). To determine the safety and tolerance of a 2 to 3 week induction course of     ganciclovir IV in immunocompromised children receiving treatment for life- or     sight-threatening cytomegalovirus infections.   "
162130|NCT00001644|"     This study will try to define how and where HIV infection persists in the body by     determining: 1) if there are cells where HIV can live for long periods of time without being     seen and destroyed by the immune system; 2) if there are sites where anti-HIV drugs cannot     penetrate enough to stop new HIV replication; and 3) if HIV in certain lymph nodes can remain     infectious for prolonged periods of time. It will also explore whether immune system damage     caused by HIV can be repaired after new virus replication is stopped with treatment.      HIV-infected patients 18 years of age and older may be eligible for this study, which will     include three groups as follows. Candidates will be screened with a medical history, physical     examination, blood and urine tests and possibly chest X-ray and electrocardiogram.      Participants will be divided into three groups according to CD4 count levels: > 500     cells/microliter of blood; between 300 and 500 cells/microliter, and < 300 cells/microliter     of blood. All participants will be treated with a combination of four antiretroviral drugs:     indinavir, zidovudine, lamivudine and nevirapine. (Exceptions to this regimen may be made in     certain circumstances for patients who cannot tolerate one of the four drugs.) In addition,     they will undergo the following procedures:      Blood tests - Blood tests will be done at screening and at study entry to evaluate the     patient's health status and measure CD4 T cell count and plasma HIV levels; at the beginning     of treatment to look for drug-related side effects; and during the course of the study to     evaluate drug effectiveness in inhibiting HIV replication; CD4 T cell levels and function.      Lymph node biopsy - Lymph node biopsies are done under local anesthesia. A small incision is     made, the node is removed, and the incision is closed with stitches. Up to two nodes may be     removed during each procedure. Patients with CD4 counts greater than 500 cells/microliter of     blood and those with counts less than 300 cells/microliter will have three lymph node     biopsies in order to 1) assess the effectiveness of therapy in inhibiting HIV replication in     the nodes (the major site of replication); 2) determine how long HIV-infected cells may     persist in the nodes after new replication is stopped by therapy; and 3) determine if immune     damage caused by HIV can be repaired when virus replication is stopped. Lymph node biopsy in     patients with counts between 300 and 500 cells/microliter of blood is required only at     baseline, although follow-up biopsies are encouraged.      Leukapheresis - In this procedure, whole blood is collected through a needle placed in an arm     vein. The blood circulates through a cell separator machine where the white cells are removed     and collected. The rest of the blood is returned to the body, either through the same needle     used to draw the blood or through a second needle placed in the other arm. The collected     white cells are used for special studies of the level and function of T cells before and     after drug treatment. Patients with CD4 counts > 500 cells/microliter and < 300     cells/microliter will undergo leukapheresis up to four times - at study entry and about 2, 6     and 12 months after starting antiretroviral therapy. Patients with CD4 counts between 300 and     500 cells/microliter will have this procedure either at study entry and 6 and 12 weeks after     initiation therapy, or on the same schedule as the other patients.   "
162131|NCT00001645|"     The purpose of this study is to evaluate, treat and follow patients with parasitic     infections.      People with a known or suspected parasitic infection who are at least 1 year old may be     enrolled. This study does not involve any experimental treatments.      Participants will have a physical examination and laboratory tests on blood, stool, or urine.     Blood samples may be collected at regular intervals, but no more than 450 ml (15 ounces) of     blood will be drawn from adults, and no more than 7 ml (1-1/2 teaspoons) per kg (2.2 pounds)     of body weight from children, in any 6-week period. Other tests may include x-rays,     electrocardiogram (EKG), or tissue biopsy (surgical removal of a small tissue sample),     depending on the individual s condition.      Patients may be offered treatment or may be referred to another study that is more     appropriate for the problem. Any treatment provided in this study will be according to     standard medical practice for the patient s specific medical problem. Patients responses to     treatment will be evaluated at regularly scheduled clinic visits. The length of time between     visits and the total duration of the study for a given individual will be determined by the     study doctor, based on that person s medical condition.   "
162132|NCT00001646|"     Invasive aspergillosis is a fungal disease which is increasing in incidence with the increase     in immunocompromised persons in our population. Persons with prolonged neutropenia secondary     to cytotoxic chemotherapies are at the highest risk for acute aspergillosis. Patients     undergoing bone marrow transplantation, receiving prolonged corticosteroid or other     immunosuppressive therapies, and persons with HIV infection and AIDS are also at risk. Even     with antifungal therapy, aspergillosis in its acute invasive forms has a high mortality. In     bone marrow transplantation patients and in those whose infection involves the brain, this     mortality is greater than 90%. Amphotericin B in its conventional form, is the current     standard treatment for this disease. Response to therapy with amphotericin B usually ranges     between 20-60% in most studies. The higher response rates are usually seen in those patients     who can tolerate this agent for at least 14 days. Because of its nephrotoxicity and other     adverse effects, alternatives to conventional amphotericin B have been sought. These     currently include liposomal forms of amphotericin B and itraconazole. Although these forms     show a decrease in adverse effects, the efficacy of these drugs has not been shown to be     equivalent to conventional amphotericin B.      Voriconazole is an investigational antifungal drug currently being brought to phase III     trials in the US. This azole has been shown active against Aspergillus spp. in vitro, and in     animal models and early human trials to be effective against aspergillosis. It has been shown     to be well-tolerated and is available in an intravenous and oral formulation.      This study will evaluate the efficacy, safety, and toleration of voriconazole compared to     conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis     in immunocompromised patients. Patients will be randomized to open-labelled therapy with     voriconazole or amphotericin B in a one-to-one ratio.   "
162133|NCT00001647|"     This study will evaluate the safety and immune system effects of infusing HIV-infected     patients with multiple doses of lymphocytes (white blood cells) from their non-infected     identical twin. It will determine whether the donated lymphocytes can improve immune function     and reduce viral load in the infected twin.      Identical twin pairs-one who is infected with HIV-1 and one who is negative for the virus-may     be eligible for this study. Candidates will be screened with blood tests, a medical history     and physical examination.      Both twin participants will receive a tetanus booster shot, if needed. The non-infected twin     will undergo apheresis to collect white blood cells. For this procedure, whole blood is     collected, similar to the procedure for donating a unit of blood from a needle in the arm.     The blood flows through a cell separator machine where the white cells are removed, and the     rest of the blood (red cells, plasma and platelets) is returned to the donor through a     catheter in the opposite arm.      The collected lymphocytes will be given intravenously (through a vein) to the infected twin     over a 60-minute period. This procedure-apheresis and infusions-will be repeated 4 days a     week to complete one cycle. The cycles will be repeated about every 8 weeks for 6 cycles     (about 1 year).      The infected twin will have blood samples drawn on the first day of each cycle, 2 weeks after     the beginning of each cycle, and 4 weeks after each cycle to evaluate immune status, viral     load and other safety parameters. The frequency of these blood tests may change as the study     progresses. The infected twin will also undergo apheresis immediately before each cycle of     infusions and one month later to test the white cells for certain immune features. The number     of apheresis procedures may be reduced as the study proceeds.   "
162146|NCT00002016|"     To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV)     monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses     during the maintenance phase of ganciclovir (DHPG) therapy to patients with AIDS and     documented evidence of CMV retinitis. In addition for those patients with positive CMV     cultures upon entry into this trial a preliminary attempt will be made to assess the     potential in vivo antiviral effects of the concomitant administration of DHPG and SDZ     MSL-109.   "
162164|NCT00002034|"     To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly     diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate     the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety     and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients     utilizing treatment with other anti-retroviral drugs will be considered for study entry on a     case by case basis.) To determine survival in this group of patients with AIDS and CMV     retinitis.   "
162134|NCT00001648|"     This study will examine the structure of the receptor molecule for the herpes simplex virus     (HSV) and determine if the receptor's structure is related to susceptibility to infection     with the virus. There are two types of herpes virus-HSV-1 and HSV-2. HSV-1 commonly causes     cold sores, and HSV-2 usually causes genital herpes. The herpes virus enters (infects) cells     through protein molecules on the cell's surface. This study will explore possible differences     between the structure of the HSV receptor molecule in different people to understand better     how infection occurs. The study will also look at proteins on white blood cells (Fc     receptors, cytokines and mannose binding protein) that may influence the risk of infection     with HSV. Information from this study may lead to new treatments to prevent HSV infection.      People 18 years of age and older who are infected with HSV and people who are not infected     with the virus may be eligible for this study. Participants will have blood drawn to confirm     whether or not they have been infected with the virus. The blood sample will also be used to     study the genes for the HSV receptor, Fc receptors, cytokines, mannose binding protein and     related proteins on the white blood cells. No more than 40 milliliters (8 teaspoons) of blood     will be drawn.      Participants who are found to have antibodies to HSV-2 will be offered counseling and advice     on practicing safe sex techniques to help prevent sexually transmitted diseases, including     HSV-2 infection.   "
162135|NCT00001649|"     This study will evaluate the effectiveness of the drug valaciclovir in preventing     transmission of genital herpes from an infected to an uninfected sexual partner. Genital     herpes is caused by the herpes simplex virus 2 (HSV-2), or, infrequently herpes simplex virus     1 (HSV-1). Valaciclovir prevents the herpes virus from multiplying and may also reduce its     transmission between partners.      Couples 18 years of age and older in which one partner is infected with HSV-2 (source     partner) and the other is not (susceptible partner), may be eligible for this study.     Candidates will be screened with blood tests for routine laboratory studies and to verify the     presence or absence of HSV-2 or HSV-1 infection.      Participants will give a medical history, undergo a physical examination, including genital     examination, and receive counseling on safer sex practices and how to recognize signs and     symptoms of a possible first episode of genital herpes. Source partners will also be     counseled on transmission of genital herpes, and susceptible partners will be interviewed     about their sexual history and practices. The source partner will be randomly assigned to     take either a 500-mg tablet of valaciclovir or placebo (a pill with no active ingredient)     daily for 8 months. All participants will be given diary cards to complete for a month-the     source partner will record any drug side effects and the susceptible partner will record any     signs or symptoms of possible HSV infection.      Participants will be seen in the clinic once a month for 8 months. At these visits, source     partners will 1) return unused study medication and the completed diary card; 2) discuss any     adverse drug side effects experienced in the last month; 3) review medications other than the     study drug taken in the last month; 4) undergo counseling on safer sex practices,     transmission of genital herpes, and recognizing signs and symptoms of a first episode of     genital herpes; and 5) review symptoms and recurrences of genital herpes experienced during     the last month. During the final visit, they will also provide a blood sample for routine     testing and possible use in future studies. Susceptible partners will 1) have a blood sample     drawn for HSV testing; 2) undergo safer sex counseling; 3) review any symptoms experienced     over the last month; 4) be interviewed about sexual exposure and practices; and 5) return the     completed diary card.      Source partners who have a recurrence of genital HSV while on the study will be asked to have     their lesions cultured and will be offered open-label valaciclovir treatment. Susceptible     partners who contract genital herpes from the source partner during the study will have a     genital examination to verify a fist episode of genital herpes and will receive 10 days of     open-label treatment with valaciclovir. Cultures will be taken from the mouth and genitals,     current medical conditions will be reviewed, blood samples will be drawn on treatment days 1     and 10, and treatment side effects will be reviewed on days 5 and 10.      At the end of the study, infected partners will be offered a 12-month course of valaciclovir,     one 500-mg tablet daily. Participants will be followed in the clinic once every 3 months to     provide blood samples, return unused study medication and the diary card, discuss any drug     side effects, review medications taken besides the study drug, and review symptoms or     recurrences of genital herpes.      All participants will be asked to complete a questionnaire for gathering information about     people with genital herpes and people at risk for the infection.   "
162136|NCT00001650|"     This study will examine how quickly white blood cells called CD4 lymphocytes reproduce and     how long they live in people infected with HIV. It will do this using bromodeoxyuridine     (BrDU), a compound that is structurally similar to thymidine, one of the building blocks of     DNA. BrDU gets incorporated into DNA instead of thymidine, but it can only get into cells     that are replicating. Therefore, measuring the proportion of cells with BrDU indicates how     many cells are replicating.      HIV-infected patients 18 years of age and older may be eligible for this study. Candidates     will be screened with a medical history, physical examination, chest X-ray, electrocardiogram     (EKG) and blood tests.      Participants will be given an infusion of BrDU through a catheter (thin plastic tube) placed     in an arm vein. Blood will be drawn up to 4 times in the first 24 hours after the infusion.      Additional samples will then be collected as often as daily for the first week, twice a week     for the next 3 weeks and then weekly to monthly for up to 1 year. Some patients may undergo a     tissue biopsy (removal of a small tissue sample from a lymph node, tonsil or colon) or     computed tomography (CT) scans of the thymus (a small gland between the lungs that     manufactures lymphocytes. Some patients will have a second infusion in order to examine     changes in the rate of CD4 replication over time or following potent antiretroviral therapy.     Patients will be followed in the clinic periodically for the first year and then will be seen     in the clinic or contacted by telephone once a year for 4 more years.      The results of this study may provide a better understanding of how HIV causes disease and     how therapy affects the immune system.   "
162137|NCT00001651|"     This study will examine how quickly white blood cells called CD4 lymphocytes replicate     (divide) and how long they live in both HIV-infected and non-infected people by measuring how     quickly the genetic material (DNA) of cells is replicated. To do this, participants will     receive infusions of glucose, a non-radioactive form of a type of sugar. Cells normally use     glucose to make various products needed for cell growth and replication, including cell DNA.     Measuring how much glucose cells incorporate into their DNA can provide important information     about cell replication. This rate of incorporation will be examined and compared in     HIV-infected people and in healthy, normal volunteers.      HIV-infected patients and non-infected healthy volunteers 18 years of age and older may be     eligible for this study. Candidates will be screened with a medical history, physical     examination, chest X-ray, electrocardiogram (EKG) and blood tests.      Participants will be given a continuous infusion of glucose at a dose of up to 60 grams     (about 2 ounces) per day for up to 5 days. The glucose will be delivered through a catheter     (thin plastic tube) placed in an arm vein. Blood samples will be collected as often as daily     in the first week following the infusion and then from twice a week to once a month for up to     4 years. Alternatively, patients may undergo leukapheresis a procedure for collecting     quantities of lymphocytes up to 10 times during the first month after the infusion, and     possibly later as well, but no more often than once every 2 weeks. For this procedure, whole     blood is collected through a needle in an arm vein. The blood circulates through a machine     that separates it into its components. The white cells are removed and the rest of the blood     is returned to the body either through the same needle or through a second needle in the     other arm. Participants may be asked to receive up to four glucose infusions. There will be     at least a 2-week interval between infusions. Participants who have more than three     leukapheresis procedures within 3 weeks will have at least 6 weeks between infusions.      Participants will be followed periodically in the outpatient clinic for evaluation and tests.      This study may provide a better understanding of how HIV causes disease and progressive     weakening of the immune system and how therapies affect immunity.   "
162138|NCT00002008|"     To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of     sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human     granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC )     injection to patients with leukopenia in association with HIV infection.   "
162139|NCT00002009|"     To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant     granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous     infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In     addition, single dose and steady state pharmacokinetics will also be determined.   "
195734|NCT00401700|"     The purpose of this trial is to assess the knowledge and attitudes of post-partum women     regarding influenza and the use of the influenza vaccine in pregnancy.   "
162147|NCT00002017|"     To evaluate the safety and immunological effects of polyethylene glycolated-interleukin-2     (PEG-IL-2) on asymptomatic (without symptoms) HIV-seropositive patients who are taking     zidovudine (AZT). To enhance measures of immune function with well-tolerated doses of     PEG-IL-2, an immunomodulator, in a regimen designed to allow its use in outpatients with     normal daily activity (i.e., full-time employment, etc.). Recombinant IL-2 (without PEG     modification) was administered to HIV-infected patients by daily intradermal injection. At     the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as     measured by natural killer cell and lymphokine-activated killer cell activity, but required     daily administration. In the current study, the PEG modification of IL-2 is used since it has     a much longer prolonged half-life compared with the non-PEG compound, without loss of     functional activity.   "
162148|NCT00002018|"     To conduct a double-blind, randomized, dose ranging study of an orally administered low dose     interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.   "
162149|NCT00002019|"     To evaluate the safety, tolerance and efficacy of three different dosage regimens of     Amphotericin B Lipid Complex (ABLC) compared to Fungizone (Amphotericin B) in patients with     AIDS and cryptococcal meningitis.   "
162150|NCT00002020|"     To evaluate the safety and tolerance, in patients with severe clinical manifestations of HIV     infection, of zidovudine (AZT) administered daily for 48 weeks as a low dose every 4 hours or     a higher dose every 12 hours.   "
162151|NCT00002021|"     To evaluate the safety and efficacy of intermittent intravenous (IV) foscarnet in the     treatment of acyclovir-resistant herpes simplex virus (HSV) infections in AIDS patients and     other immunocompromised patients. To evaluate the necessity, efficacy, and safety of IV     maintenance foscarnet therapy in preventing recurrent disease. To confirm the     pharmacokinetics of intermittent induction and maintenance IV regimens.   "
162152|NCT00002022|"     The objective of the Eprex (erythropoietin) Treatment Program is to provide erythropoietin     for the treatment of anemia in AIDS patients.   "
162153|NCT00002023|"     To establish the relationship between the oral dose of zidovudine (AZT) and its hematologic     toxicity. AZT has preliminarily been shown to decrease significant events and death in a     group of AIDS / Pneumocystis carinii pneumonia (PCP) and AIDS related complex (ARC) patients     followed at this time for a limited period. If these data withstand further follow-up, it     appears that AZT is a potential antiretroviral agent that may have application in the use of     all stages of HIV disease. At this time the optimal dose that will not cause significant     toxicity is not known. If this drug has widespread application, it becomes imperative to     further study both the dose and the toxicity. Patients with documented HIV viremia and who     are well will be evaluated in a dose-escalating protocol for toxicity, persistent viremia,     evidence of improvement of immune dysfunction, and the development of further manifestation     of HIV disease. Drug levels will be monitored and correlated with the toxicity and viremia.   "
162154|NCT00002024|"     To provide ganciclovir on a compassionate use basis to immunocompromised patients with     serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient     population.   "
162155|NCT00002025|"     To make intravenous (IV) ganciclovir available to immunocompromised patients with     life-threatening or sight-threatening Cytomegalovirus (CMV) infection, where the symptoms of     the disease are too severe to allow admission to a controlled clinical study of ganciclovir     therapy. To determine the safety and tolerance of 2 - 3 weeks induction course of ganciclovir     IV followed by a maintenance course of ganciclovir IV for an indefinite duration. To tabulate     the patient's clinical response.   "
162156|NCT00002026|"     To evaluate the efficacy of oral acyclovir for the treatment and suppression of Epstein-Barr     virus (EBV) related hairy leukoplakia (HL). To determine the long-term safety of acyclovir in     the AIDS-related complex (ARC) patient with HL. To monitor the progression of HIV disease in     the HL patient and compare to existing historical control data.   "
162157|NCT00002027|"     To evaluate the safety and efficacy of diclazuril capsules compared with placebo capsules as     treatment of cryptosporidial related diarrhea in AIDS patients. Treatment efficacy will be     based on the drug's clinical results and on its anti-protozoan effects. Safety will be     assessed by the occurrence of side effects as reported by patients at their visits and by     frequent monitoring of hematology, biochemistries, and urinalysis.   "
162158|NCT00002028|"     The objective of this treatment IND protocol is to make didanosine (ddI) available to     patients with HIV infection (suffering from AIDS related complex (ARC) or AIDS) who have     developed documented intolerance to zidovudine (AZT) and cannot enter a Phase II ddI program     due to protocol exclusion or geographic location.   "
162159|NCT00002029|"     To compare two lipid emulsions in the long-term parenteral alimentation of patients with AIDS     in relation to: Clinical effectiveness. Effect on immunologic function. Effect on HIV load as     measured by p24 antigen levels. Effect on relative HIV infectivity.   "
162160|NCT00002030|"     To evaluate the safety, tolerability, and efficacy of long term, bi-weekly administration of     aerosol pentamidine when used as a prophylactic agent in patients who have had at least two     or more episodes of AIDS-associated Pneumocystis carinii pneumonia (PCP).   "
162161|NCT00002031|"     To evaluate the effect of application of Dinitrochlorobenzene (DNCB) on the number,     morphology, and antigen expression of epidermal Langerhans cells in AIDS and AIDS related     complex (ARC) patients.   "
162162|NCT00002032|"     The primary objectives of this trial are: To compare the safety of oral rifabutin versus     placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients     with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in     these patients. A secondary objective is to compare clinical response, quality of life     (Karnofsky), and survival between these two groups.   "
162163|NCT00002033|"     To compare the effect of AS-101 to that of placebo on clinical efficacy and immunologic     function in HIV positive patients with advanced disease. To compare the effect of AS-101 to     that of placebo on occurrence of disease progression in HIV positive patients with advanced     disease as defined by: (1) development of new diagnostically confirmed major opportunistic     infection(s); or (2) development of AIDS-related dementia. To compare the effect of     zidovudine (AZT) plus AS-101 versus AZT alone (placebo arm) on clinical efficacy and     immunologic function in patients who require anti-viral therapy due to disease progression.     Garlic capsules will be given to all study participants to mask the obvious garlic odor of     AS-101.   "
162188|NCT00002058|"     This study will examine the effectiveness of clofazimine in the prophylaxis of Mycobacterium     avium complex infection in HIV infected individuals who are at risk to develop this     untreatable opportunistic disease. In the absence of truly effective antiretroviral therapy,     a potential mode of treatment of patients with HIV infection is to prevent the development of     the life-threatening opportunistic infections. Current studies demonstrate a possible     efficacy of clofazimine in the prophylaxis against Pneumocystis carinii pneumonia (PCP), the     most common AIDS-defining opportunistic infection. Future studies will examine the potential     for prophylaxis against the other opportunistic infections. This proposal hopes to define the     role of prophylactic clofazimine in preventing the currently untreatable Mycobacterium avium     complex infection. AMENDED: To include prophylaxis for Asymptomatic and ARC.   "
162189|NCT00002059|"     The objective of this double-blind placebo-controlled study is to evaluate the effect of     Isoprinosine in a group of homogenous male volunteers who present with immunologic defects     relative to:        -  Comparison of total helper and suppressor T-cell number between the groups.        -  Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative          response and natural killer (NK) cell activity between the groups.        -  Determination of the clinical course of the volunteers after discontinuance of          Isoprinosine.   "
162190|NCT00002060|"     The objective is to determine the effect of Isoprinosine (inosine pranobex) in homosexual     male patients with AIDS related complex (ARC) in delaying the onset of AIDS. Secondly, to     determine the effect of Isoprinosine in decreasing the severity and/or incidence of lesser     opportunistic infections and/or other conditions associated with ARC.   "
162191|NCT00002061|"     The objective of this Phase III, randomized, double-blind, placebo-controlled study in     patients with immunologic deficiency is to determine the effect of isoprinosine in producing     an immuno-restorative response within the study observation period (including the 2-month     period following cessation of the 28 days of treatment), measured by one or more of the     following immunologic parameters:        -  Increase in natural killer (NK) cell activity.        -  Increase in total T-cells (OKT-11).        -  Increases in absolute number and percentages of T-helper cells (OKT-4).   "
162192|NCT00002062|"     This protocol provides for the availability of spiramycin under compassionate-use conditions     for the treatment of chronic diarrhea due to cryptosporidium in patients with a compromised     immune system, thus deriving additional information regarding its safety and efficacy     profile.   "
162193|NCT00002063|"     Primary: To determine the clinical effect of zidovudine (AZT) compared to placebo in terms of     time to progression to AIDS (i.e., occurrence of major opportunistic infections, dementia,     and malignancies) or death. Initial drug assignment will be changed to open-label AZT for     patients who experience a sustained decline in CD4 lymphocyte concentration to less than 200     cells/mm3, but analysis will be based on initial treatment assignment. To determine the     immunologic effect of AZT compared to placebo in terms of time to drop in CD4 lymphocyte     concentration of at least 25 percent from baseline assessment. To determine the antiviral     effect of AZT compared to placebo in eradicating or suppressing HIV. Secondary: To determine     the effect of AZT compared to placebo on the immune status of HIV-infected patients by     comparing lymphocyte profiles and indices. To determine the long-term toxicities of AZT     compared to placebo in terms of abnormalities in BL, hepatic function, renal function, skin,     gastrointestinal system, and central nervous system. To describe the natural history of AIDS     related complex (ARC) in placebo patients in terms of initial CD4 lymphocyte concentration     and the Walter Reed staging system.   "
162194|NCT00002064|"     To compare pyrimethamine and intravenous (IV) clindamycin vs. pyrimethamine and sulfonamides     in the treatment of AIDS patients with central nervous system (CNS) Toxoplasma gondii.   "
162195|NCT00002065|"     To assess the safety and efficacy of depot disulfiram as a new treatment for AIDS and AIDS     related complex.   "
162196|NCT00002066|"     Examine the ability of thymopentin (Timunox) to:      Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter     the clinical findings in patients infected with HIV who do not yet have AIDS.   "
162197|NCT00002067|"     To compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia,     calorie intake, and nutritional parameters of patients with a confirmed diagnosis of AIDS. To     determine whether megestrol acetate relative to placebo improves the perception of well-being     among AIDS patients with cachexia. To evaluate megestrol acetate's effect on immune function     via skin test reactivity, T4/T8 ratio, and total lymphocytes.   "
162198|NCT00002068|"     To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in     combination with flucytosine, as treatment for acute cryptococcal meningitis.   "
162199|NCT00002069|"     To determine if ditiocarb sodium (sodium diethyldithiocarbamate; DTC) restores immune and     host defense function; if DTC ameliorates the AIDS related complex (ARC) symptoms in patients     with AIDS and ARC; if DTC prevents progression from ARC to AIDS or progression of AIDS; and     if DTC prolongs survival in AIDS.   "
162200|NCT00002070|"     To determine whether co-administration of sargramostim (granulocyte-macrophage     colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously     intolerant because of neutropenia defined as an absolute neutrophil count less than 500     cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable     outcome as defined by a delayed time to progression of retinitis; to confirm the safety and     co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV     p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving     ganciclovir with or without GM-CSF.   "
162201|NCT00002071|"     To determine the safety and efficacy of erythropoietin administered to AIDS patients with     anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.   "
162202|NCT00002072|"     To determine the safety and efficacy of erythropoietin (r-HUEPO) administered to AIDS     patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.   "
162203|NCT00002073|"     To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS     patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.     Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.   "
176033|NCT00144547|"     This is an open-label, extension, Phase III study to evaluate the long-term safety and     efficacy of MRA in patients with RA who participated in Study MRA012JP.   "
162207|NCT00002077|"     To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial     treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS     patients. Lack of satisfactory response will allow increase of dose. Both newly diagnosed and     relapsed patients are eligible.   "
162208|NCT00002078|"     To determine the safety and tolerance of subcutaneous injections of natural interferon alpha     (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these     individuals.   "
162209|NCT00002079|"     To assess the dose-related antiviral effects of SC-48334 and zidovudine (AZT) administered in     combination or individually in HIV-1 positive patients with 200 - 500 CD4+ cells/mm3. To     determine the safety of escalating doses of SC-48334 when administered in combination with     any of three doses of AZT to symptomatic HIV-1 positive patients with 200 - 500 CD4+     cells/mm3, and to assess the pharmacokinetics of the two drugs, given separately and in     combination.   "
162210|NCT00002080|"     Primary: To provide rifabutin to HIV positive patients in an attempt to prevent or delay     Mycobacterium avium Complex (MAC) infection by a daily dose of rifabutin.      Secondary: To further characterize the safety of rifabutin monotherapy in preventing or     delaying MAC bacteremia in HIV positive patients with CD4 counts = or < 200.   "
162211|NCT00002081|"     To provide zalcitabine ( dideoxycytidine; ddC ) for use with zidovudine ( AZT ) in patients     with advanced HIV infection. To observe serious toxicities in this population.   "
162212|NCT00002082|"     To evaluate the safety and efficacy of azithromycin in the treatment of intestinal     cryptosporidial infection in AIDS patients.   "
162213|NCT00002083|"     To compare the effects of intranasal peptide T and placebo in the treatment of painful     peripheral neuropathy associated with human immunodeficiency virus (HIV) infection.   "
162214|NCT00002084|"     To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared     to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with     CD4 counts = or > 100 cells/mm3.   "
162216|NCT00002086|"     Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1     (Retrovir/HIVID/Wellferon) can produce complete responses (i.e., CD4 counts return to >= 800     cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To     determine the antiviral effect of the combination therapies as evidenced by measures of     quantitative viral load performed at select study centers only.      Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in     maintaining or increasing CD4 counts and preventing disease progression as evidenced by the     development of an AIDS-defining indicator disease. To determine the effect of these regimens     on secondary measures of clinical status (e.g., performance score, weight change, and     secondary infections) and on measures of virologic activity such as serum p24 antigen. To     assess the safety and tolerance of these regimens.   "
162217|NCT00002087|"     To investigate the safety and tolerance of an increasing number of infusions per week of     alvircept sudotox ( sCD4-PE40; soluble CD4-Pseudomonas exotoxin ) at a fixed dose when     administered to HIV-1-infected individuals. To investigate the effect of sCD4-PE40 on the     following parameters: T lymphocyte subsets, plasma HIV RNA and cellular HIV proviral DNA in     PBMC and CD4 cells, p24 levels, serum beta-2 microglobulin, and neopterin levels.   "
162218|NCT00002088|"     To assess the efficacy of Saccharomyces boulardii (a nonpathogenic yeast) in producing a     significant reduction in diarrheal symptoms in HIV-infected patients with chronic diarrhea.   "
162219|NCT00002089|"     To evaluate the efficacy and safety of azithromycin given chronically for the treatment of     Mycobacterium avium (MAC) bacteremia in patients failing or intolerant of current available     MAC therapy.   "
162220|NCT00002090|"     To evaluate the efficacy and safety of two doses of azithromycin given chronically for the     treatment of Mycobacterium avium bacteremia in AIDS patients.   "
162221|NCT00002091|"     PRIMARY: To determine whether pentoxifylline changes the self-reported measures of quality of     life status, using measures of scores from double-blinded drug withdrawal and drug restart     periods.      SECONDARY: To measure the changes in monthly CD4 counts, fasting serum triglyceride levels,     and weight; to assess the safety of pentoxifylline in HIV-infected persons.   "
162222|NCT00002092|"     To determine the change in CD4 count after 4 and 8 weeks in HIV-infected patients treated     with cimetidine compared to placebo. To observe time-associated trends at weeks 4, 8, 12, and     16 in the change of CD4 counts for patients taking cimetidine for the full 16 weeks. To     establish a safety record for cimetidine use in HIV-positive patients.   "
162223|NCT00002093|"     To compare the toxicity profiles (severity and time to onset from initiation of therapy)     between daunorubicin (liposomal) and combination chemotherapy with     doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with     antiretroviral therapy. To compare the duration of responses, response rates, and times to     response.   "
162224|NCT00002094|"     To determine the time course of development of resistance to atevirdine mesylate ( U-87201E )     in patients with HIV isolates showing in vitro resistance to zidovudine ( AZT ). To determine     the genotype changes in HIV reverse transcriptase associated with in vitro AZT resistance to     U-87201E. To determine the genotype and phenotype effects of treatment with a     nondideoxynucleoside agent on the alterations of the HIV-1 population associated with in     vitro AZT resistance. To determine whether serial passage of patient pre-drug HIV isolates in     the presence of U-87201E will generate the resistant mutants that may subsequently emerge in     the patients.   "
162225|NCT00002095|"     To evaluate the efficacy of oral ganciclovir in preventing progression to cytomegalovirus     (CMV) disease (e.g., CMV retinitis, gastrointestinal CMV disease) in CMV-infected people with     HIV infection and CD4 lymphocyte counts <= 100 cells/mm3. To evaluate the efficacy of this     drug in reducing morbidity associated with coinfection by both CMV and HIV.   "
162226|NCT00002096|"     To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and     oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI). To determine     whether concurrent administration of probenecid affects the pharmacokinetics of oral     ganciclovir. To obtain data on the short-term safety of oral ganciclovir administered     concurrently with AZT, ddI, or probenecid in HIV-positive patients.   "
173878|NCT00118417|"     This study will determine the effectiveness of different treatments for panic disorder     symptoms in individuals who still have symptoms after initial treatment with medication.   "
162228|NCT00002098|"     To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI)     compared with ddI alone. To determine whether the combination of lentinan and ddI produces a     significant immunorestorative effect within the study observation period (6-12 months) as     measured by an increase in one or more of the following: neutrophil count and activity,     T-cell subsets, and a decrease in p24 antigen.   "
162229|NCT00002099|"     To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI)     in comparison with ddI alone. To determine whether the combination of lentinan and ddI     produces a significant immunorestorative effect within the study observation period (6-12     months) as measured by an increase in one or more of the following: neutrophil count and     activity, T-cell subsets, and a decrease in p24 antigen.   "
162230|NCT00002100|"     To assess the safety and tolerance of curdlan sulfate, as well as its anti-HIV activity, in     HIV-infected patients with CD4 T-lymphocytes less than 500 cells/mm3, using first single     doses and then, after FDA review, daily doses for 7 days.   "
162231|NCT00002101|"     To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two     different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients     with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks     post-randomization. To assess survival and comparative tolerability among the three treatment     regimens.   "
162232|NCT00002102|"     To provide trimetrexate glucuronate to immunosuppressed patients with Pneumocystis carinii     pneumonia (PCP) for whom this investigational compound could provide significant medical     benefit.   "
162233|NCT00002103|"     To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in     European patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have     demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or     parenteral pentamidine).   "
162237|NCT00002107|"     To determine the MTD and dose-limiting toxicities of recombinant interleukin-2 (aldesleukin;     Proleukin) administered subcutaneously in HIV-seropositive patients. To identify a tolerable     subcutaneous regimen that will replicate the immunologic improvement demonstrated in the     outpatient polyethylene glycolated IL-2 and high-dose continuous infusion IL-2 studies. To     evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously     administered Proleukin in this patient population.   "
162238|NCT00002108|"     To make lamivudine (3TC) available to patients with progressive, symptomatic HIV disease who     cannot participate in a controlled clinical trial and who are refractory or unable to     tolerate other therapies. To collect data pertaining to the safety of 3TC at two dose levels.     To evaluate the effect of 3TC on markers of hepatitis B in co-infected patients at five to     ten selected sites.   "
162239|NCT00002109|"     To confirm results from a previous study in which the combination of thymopentin plus     zidovudine ( AZT ), an antiretroviral agent, slowed disease progression in HIV-infected     asymptomatic patients. To evaluate the efficacy and safety of thymopentin in HIV-infected     asymptomatic patients receiving either monotherapy with AZT, didanosine ( ddI ), or stavudine     ( d4T ), or combination antiretroviral therapy with AZT / ddI or AZT / zalcitabine ( ddC ).   "
162240|NCT00002110|"     To determine the safety and tolerance of low-dose versus high-dose cysteamine administered     concurrently with zidovudine (AZT). To determine the pharmacokinetics and effects on immune     function and viral load in patients receiving these drug regimens.   "
162241|NCT00002111|"     To investigate the toxicity, antiviral activity, and pharmacokinetics in HIV-infected     patients receiving 16 weeks of oral saquinavir mesylate ( Ro 31-8959 ) at one of two doses.   "
162242|NCT00002112|"     To compare the efficacy, safety, and toleration of fluconazole as a single daily oral     suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the     treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection.   "
162243|NCT00002113|"     To evaluate and estimate the safety and efficacy of the combination of fluconazole and     flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS.      Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not     been associated with hematologic suppression and does not produce renal impairment that can     result in higher serum flucytosine levels, this combination may be better tolerated than is     amphotericin B plus flucytosine.   "
162244|NCT00002114|"     To compare the efficacy and safety of orally administered Procysteine with placebo in     HIV-infected patients who are receiving 1 of the following: (1) zidovudine (AZT) alone; (2)     didanosine (ddI) alone; (3) AZT plus ddI; or (4) AZT plus zalcitabine (ddC).   "
162245|NCT00002115|"     To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir )     when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients     with advanced HIV disease.   "
162246|NCT00002116|"     To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory     mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical     HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes     simplex virus disease in AIDS patients. To evaluate the virologic effects of topical HPMPC     therapy on herpes simplex virus shedding from refractory lesions.   "
162247|NCT00002117|"     To investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT     ) schedule for use in combination therapy in patients with HIV infection.   "
162248|NCT00002118|"     To allow, on a compassionate use basis, zalcitabine (ddC) for pediatric patients with     symptomatic HIV disease who have failed treatment or who are intolerant to zidovudine (AZT),     or who have completed other ddC protocols, or who are ineligible for ongoing clinical trials.   "
162249|NCT00002119|"     To evaluate the clinical toxicity, safety, and MTD of WF 10 ( TCDO ) intravenous solution     administered to patients with HIV infection. To evaluate the potential anti-HIV activity of     TCDO.   "
162250|NCT00002120|"     To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with     leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS     and moderately severe Pneumocystis carinii pneumonia (PCP). To determine the pharmacokinetic     parameters of TMTX, leucovorin, and dapsone and of TMP/SMX when given to patients with AIDS     and moderately severe PCP.   "
173879|NCT00118430|"     This study will evaluate the effectiveness of a stepped care approach in treating depression     and reducing pain.   "
162252|NCT00002122|"     PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for     the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected     patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of     deep fungal infections in this patient population.      SECONDARY: To determine the incidence of bacterial (including mycobacterial) infections,     cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing     regimens. To determine the incidence of oropharyngeal and vaginal candidiasis in patients     treated with daily versus weekly fluconazole. To compare survival and outcomes of primary     endpoints in the treatment arms.   "
162253|NCT00002123|"     To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate     (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.   "
162254|NCT00002124|"     PART I: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of three fixed     doses of delavirdine mesylate (DLV) in combination with zidovudine (AZT) versus AZT alone in     HIV-positive patients.      PART II: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of ZDV plus 3TC     with or without DLV versus ZDV plus DLV in HIV-positive patients.   "
162255|NCT00002125|"     To assess the relative efficacy of oral versus intravenous hydration during foscarnet sodium     (Foscavir) induction therapy, as determined by changes in creatinine clearance. To estimate     the timing and volume of oral fluid hydration required to establish a diuresis before and     during intravenous Foscavir therapy. To assess the general tolerance of two hydration     regimens by the adverse event profile associated with each.   "
162258|NCT00002128|"     To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA     (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.   "
162264|NCT00002134|"     To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV)     disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal     ganciclovir implant. To compare safety and tolerance, time to progression, quality of life,     and survival among patients treated with an intravitreal ganciclovir implant, with and     without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.   "
162265|NCT00002135|"     To provide oral ganciclovir to patients who require maintenance for control of     cytomegalovirus (CMV) retinitis, but who lack patent permanent central venous access for     long-term administration of intravenous drugs.   "
162266|NCT00002136|"     To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152)     and to establish the MTD at each of the different dosing schedules.   "
162267|NCT00002137|"     To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152)     and to establish the MTD at each of the different dosing schedules.   "
162268|NCT00002138|"     To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152)     and to establish the MTD at each of the different dosing schedules.   "
162269|NCT00002139|"     To compare the uptake of azithromycin in white cells relative to plasma concentrations in     HIV-infected patients.   "
162270|NCT00002140|"     To evaluate the efficacy and safety of two different doses of azithromycin in combination     with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC)     infection, and to determine whether an azithromycin-containing regimen is at least as safe     and effective as the same regimen containing clarithromycin..   "
162271|NCT00002141|"     To assess the safety of single oral doses of 1592U89 (abacavir succinate, ABC) administered     to HIV-positive individuals. To determine the pharmacokinetics of 1592U89 after single oral     doses. To determine the effects of food on the bioavailability of 1592U89.   "
162272|NCT00002142|"     To evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with     relapsing cytomegalovirus (CMV) retinitis. To determine the time to retinitis progression in     this patient population. To evaluate the impact of cidofovir therapy on visual acuity.   "
162273|NCT00002143|"     To determine the efficacy of acitretin in the treatment of psoriasis in HIV/AIDS patients.      Etretinate, a retinoid, has proven successful in the treatment of HIV-infected patients with     psoriasis, but it has an elimination half-life of 100 days. Acitretin, a metabolite of     etretinate, has a much shorter half-life of 2 to 3 days. Acitretin has proven effective in     treating psoriasis in patients without HIV infection by reducing skin involvement and     clearing of the condition, but it has not been thoroughly evaluated in HIV-infected patients.   "
162274|NCT00002144|"     PRIMARY: To evaluate the clinical activity of foscarnet cream on the index lesion of     mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients previously     unresponsive to acyclovir treatment.      SECONDARY: To evaluate the clinical activity and virologic activity of foscarnet cream on all     treated lesions in this patient population. To evaluate the local tolerance and side effects     of treatment with foscarnet cream in this patient population.   "
162275|NCT00002145|"     PRIMARY: To compare the frequency of and time to relapse of Cytomegalovirus (CMV)     gastrointestinal disease following foscarnet induction therapy only versus induction plus     maintenance therapy.      SECONDARY: To determine frequency of and time to recurrence of gastrointestinal symptoms,     response rate of pathological lesions, and incidence of nongastrointestinal CMV disease in     this patient population.   "
162276|NCT00002146|"     To determine whether acute ionized hypomagnesemia and hypocalcemia immediately following     foscarnet infusions can be lessened or eliminated by prior infusion of magnesium sulfate. To     determine whether reductions in ionized magnesium, ionized calcium, and parathyroid hormone     levels following foscarnet infusions are lessened by preinfusion of magnesium sulfate. To     evaluate the safety of intravenous magnesium sulfate prior to foscarnet infusion by     monitoring blood pressure, heart rate, and heart rhythm. To characterize the effect of     magnesium sulfate on foscarnet blood levels and urinary excretion of calcium, magnesium,     phosphate, and foscarnet.   "
162277|NCT00002147|"     To provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's     sarcoma patients who have no remaining treatment options other than DOX-SL or patients who     have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is     medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with     Kaposi's sarcoma who have previously received systemic chemotherapy with or without an     anthracycline.   "
162279|NCT00002149|"     To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of     pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin     ) in reducing symptoms and recurrence of acute HIV-related sinusitis.      Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with     potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of     life-threatening sepsis, and progress to central nervous system involvement. Symptoms of     sinusitis in HIV patients are often refractory to aggressive Western medical management, and     antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and     herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic     therapy.   "
162280|NCT00002150|"     To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and     in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic     HIV infection. To examine the demographic effects on population pharmacokinetics and     pharmacodynamics of MDL 28,574A alone and in combination with AZT.   "
162281|NCT00002151|"     To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and     in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic     HIV infection. To examine the demographic effects on population pharmacokinetics and     pharmacodynamics of MDL 28,574A alone and in combination with AZT.   "
162282|NCT00002152|"     The purpose of this study is to see if it is safe and effective to give WF 10 (TCDO) to     patients with advanced HIV disease who cannot or will not take zidovudine, didanosine,     zalcitabine, or stavudine. This study also examines how TCDO affects the levels of HIV in the     body. TCDO is a solution delivered through a vein.   "
162294|NCT00002164|"     To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation     administered to HIV infected or exposed children and infants (0 to 13 years of age). An     evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard     tablet formulation in older children (7 to 13 years of age) will also be conducted.   "
162295|NCT00002165|"     To make nelfinavir mesylate (Viracept) available for treatment of HIV positive patients who     are unable to take the three commercially available protease inhibitors (because of failure,     intolerance, or contraindication) and who have a CD4 cell count of <= 50. To obtain     additional information on the safety profile of nelfinavir mesylate (Viracept).      (PER AMENDMENT 1/8/97: People now qualify for the Viracept Program if they are unable to take     indinavir and/or ritonavir due to intolerance, contraindication or prior failure.)   "
162296|NCT00002166|"     To provide access to Viramune and to evaluate the tolerance and safety of Viramune in     patients with progressive, symptomatic HIV disease who failed or are intolerant to currently     approved treatment for HIV-1 infection and who are unable to participate in another Viramune     controlled clinical trial and have a compelling need for anti-HIV treatment.   "
162297|NCT00002167|"     To determine the objective tumor response and remission rate of AIDS-related Kaposi's     sarcomas (KS) following a single dose of tin ethyl etiopurpurin (SnET2) followed by     photodynamic therapy (PDT). To determine the systemic and local toxicity, and morbidity     safety profile of SnET2-PDT.   "
162298|NCT00002168|"     The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug     combinations when given to HIV-infected patients who have never been treated with anti-HIV     drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other     combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.   "
162299|NCT00002169|"     The purpose of this study is to see if it is safe and effective to give Viracept to AIDS     patients who are already being treated for cytomegalovirus (CMV) retinitis.   "
162300|NCT00002170|"     The purpose of this study is to see if it is safe and effective to give Viracept to AIDS     patients who are being treated for MAC.   "
162301|NCT00002171|"     The purpose of this study is to see if it is safe and effective to give Viracept plus     stavudine (d4T) plus lamivudine (3TC) to HIV-positive women with a CD4 count <= 400     cells/mm3. This study also examines how the body handles Viracept when given with d4T and     3TC.   "
162302|NCT00002172|"     To provide product through an expanded access program to HIV-infected patients with CD4     counts less than 300 cells/ml.   "
162303|NCT00002173|"     To provide an alternative therapy to HIV-infected patients for whom there is no comparable or     satisfactory alternative drug or therapy available.   "
162304|NCT00002174|"     To determine if Thalidomide modulates the production of HIV-suppressor factors (MIP-1 alpha,     MIP-1 beta, Rantes) and TH1 type cytokines (IL-12 and INF-gamma) in HIV-infected patients and     alters viral load.   "
162305|NCT00002175|"     To evaluate the efficacy of dinitrochlorobenzene (DNCB) in patients with early HIV infection     by monitoring immunologic parameters and serum HIV RNA. To facilitate the understanding of     possible alterations in the immunological status of the HIV+ patient cohort.   "
162306|NCT00002176|"     To assess the magnitude and duration of the antiviral activity in plasma and the incidence     and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety     and tolerability of this combination therapy and the magnitude and duration of the effect of     this therapy over CD4 cell counts.   "
162307|NCT00002177|"     To assess the magnitude and duration of the antiviral activity in plasma and the incidence     and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety     and tolerability of this combination therapy and the magnitude and duration of the effect of     these drugs over CD4 cell counts.   "
162308|NCT00002178|"     To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of     detection (< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute     change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study     treatment. To collect safety data on the treatment regimens. To determine the percentage of     patients without SQV soft gel capsules resistance-associated mutations at week 24.   "
162326|NCT00002196|"     The purpose of this study is to see if it is safe and effective to give CI-1012 to     HIV-infected patients who do not have any symptoms of the disease. This study also examines     how the body handles CI-1012.   "
163620|NCT00003778|"     Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have     recurrent or metastatic soft tissue sarcoma. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die.   "
162309|NCT00002179|"     To evaluate the ability of the combination of indinavir, zidovudine, and lamivudine to     suppress HIV-1 infection as measured by: (1) the maintenance of HIV-1 serum viral RNA below     the limit of detection of the most sensitive validated assay (ultradirect assay) and (2)     absence of evidence of infectious virus in lymph node, cerebrospinal fluid (CSF), peripheral     mononuclear cells (PBMCs), and semen.      It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will     result in:        1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in          50% of patients who have undetectable viral RNA by the most sensitive validated assay          available (ultradirect assay) for at least 48 weeks.        2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to          below the limit of detection of the ultradirect assay for at least 48 weeks in at least          25% of patients.        3. Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the          limit of detection of the standard Amplicor assay (i.e., negative) in at least 90% of          patients by Week 16.        4. Suppression of HIV-1 infection, suggesting eradication of the virus as measured by          maintenance of serum viral RNA to below the limit of detection of the ultradirect assay          for at least 24 weeks after discontinuation of indinavir, zidovudine, and lamivudine in          patients who have maintained this level of suppression for at least 120 weeks on          therapy.   "
162310|NCT00002180|"     The purpose of this study is to see if it is safe and effective to give PMPA to HIV-infected     patients. This study also examines how the body handles PMPA.   "
162311|NCT00002181|"     The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in     treating herpes simplex in patients with AIDS who do not respond to acyclovir.   "
162312|NCT00002182|"     The purpose of this study is to see if megestrol acetate is safe and effective in treating     HIV-infected children with failure to thrive (FTT).   "
162378|NCT00002223|"     The purpose of this study is to determine how many HIV-infected patients continue taking     ritonavir/indinavir combination after having taken indinavir three times a day as part of     their anti-HIV drug therapy. This study also examines the safety and effectiveness of the     ritonavir/indinavir combination.   "
162313|NCT00002183|"     To assess the safety and tolerance of multiple oral doses of 141W94 alone, in combination     with 1592U89, and in combination with Retrovir and Epivir, administered to patients with HIV     infection as measured by the development of clinical adverse experiences and laboratory test     abnormalities. To determine the steady-state pharmacokinetics of 141W94 alone and in     combination with 1592U89 after multiple oral dosing. To obtain preliminary evidence of     antiretroviral activity of 141W94 alone and in combination with 1592U89, the antiretroviral     effect of combined Retrovir/Epivir and the antiretroviral effect of 141W94 when added to     Retrovir/Epivir or to 1592U89/Retrovir/Epivir.   "
162314|NCT00002184|"     To evaluate the safety and tolerance of the combination of adefovir dipivoxil at two     comparative doses and nelfinavir plus saquinavir SGC administered orally (Group 1) vs. the     combination of adefovir dipivoxil and nelfinavir plus either zidovudine, lamivudine, or     stavudine (Group 2) vs. the combination of adefovir dipivoxil and saquinavir SGC plus either     zidovudine, lamivudine, or stavudine (Group 3) in HIV-infected patients with prior nucleoside     reverse transcriptase inhibitor therapy but no prior exposure to protease inhibitors who have     CD4 cell counts >= 100 cells/mm3 and an HIV-1 RNA baseline copy number >= 5000 copies/ml. To     determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of     detection (<500 copies/ml) at 20 weeks of study therapy and the average reduction in HIV-1     RNA from baseline through study week 20. To evaluate the durability of the antiviral response     through 48 weeks of study in patients who continue on study therapy after week 24.   "
162315|NCT00002185|"     To determine the effect of Viracept in combination with modified antiretroviral therapy on     the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).   "
162316|NCT00002186|"     To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303     gel in combination with acyclovir, relative to acyclovir alone, for the treatment of     recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and     neighboring areas, in patients with AIDS.   "
162317|NCT00002187|"     The purpose of this study is to compare the safety and effectiveness of two dosage schedules     for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis   "
162318|NCT00002188|"     The purpose of this study is to see if ALRT1057 is safe and effective in treating patients     with AIDS-related Kaposi's sarcoma (KS).   "
162319|NCT00002189|"     To determine response rate, median time to tumor progression, qualitative and quantitative     toxicity and reversibility of toxicity in patients with advanced refractory AIDS-associated     Kaposi's sarcoma (KS) administered a 3-hour infusion of paclitaxel every 14 days. To evaluate     the clinical benefit of paclitaxel in this patient population by evaluating self-reported     responses to the Symptom Distress Scale and by documenting and evaluating any changes in     their lymphedema, pain and disfiguring facial lesions.   "
162320|NCT00002190|"     To explore the antiviral efficacy, tolerability and safety of saquinavir plus zidovudine plus     lamivudine.   "
162321|NCT00002191|"     To evaluate the efficacy (stool frequency) and safety (adverse experiences) of albendazole,     administered for 28 days, compared to placebo and for 62 days in open-label fashion, in     treating intestinal microsporidiosis in HIV-positive patients. To assess the effect of     albendazole on stool volume, weight gain, microsporidial counts in small bowel biopsies, and     on the relationship between microsporidial counts in stool and stool frequency and volume. To     correlate microsporidial counts with the clinical course of microsporidiosis.   "
162322|NCT00002192|"     To determine the antimicrobial activity and tolerability of rifapentine alone and in     combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC)     bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite,     25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of     azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.   "
162323|NCT00002193|"     The purpose of this study is to see if it is safe and effective to add a new protease     inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse     transcriptase inhibitors (NRTIs).   "
162372|NCT00002217|"     The purpose of this study is to test the effectiveness of Combivir plus abacavir plus 141W94     in patients who previously have used anti-HIV drugs.   "
162327|NCT00002197|"     The purpose of this study is to see if it is safe to give 1592U89 to children (aged 6 months     until 14th birthday) with advanced HIV infection who have few treatment options available.     The study also examines the effect 1592U89 has on the levels of HIV in the blood.   "
162328|NCT00001357|"     This is a Phase I dose-escalating safety study aimed at identifying the maximum tolerated     dose (MTD) for an outpatient regimen while exposing the minimum number of patients to a dose     less than MTD. The anticipated accrual will be approximately 15 patients and the study will     take one year to complete. Patients will receive Proleukin® (Registered Trademark)     subcutaneously at their assigned dose level once per day for 5 days approximately every eight     weeks for a total of 6 months. A cycle of therapy is defined as 5 days of Proleukin®     (Registered Trademark) plus antiviral therapy followed by 7 weeks of antiviral therapy alone.     If tolerated, each patient will receive 3 cycles of therapy and, following completion of     three cycles, will be eligible for extended treatment. IL-2 injections will be delivered by     study personnel on an outpatient basis for at least the first cycle of therapy.   "
162329|NCT00001359|"     A subgroup of patients with childhood-onset obsessive-compulsive disorder (OCD) and/or tic     disorders has been identified who share a common clinical course characterized by dramatic     onset and symptom exacerbations following group A beta-hemolytic streptococcal (GABHS)     infections. This subgroup is designated by the acronym PANDAS (Pediatric Autoimmune     Neuropsychiatric Disorders Associated with Streptococcal infections). There are five clinical     characteristics that define the PANDAS subgroup: presence of OCD and/or tic disorder;     prepubertal symptom onset; sudden onset or abrupt exacerbations (relapsing-remitting course);     association with neurological abnormalities (presence of adventitious movements or motoric     hyperactivity during exacerbations); and temporal association between symptom exacerbations     and GABHS infections. In this subgroup, periodic exacerbations appear to be triggered by     GABHS infections in a manner similar to that of Sydenham's chorea, the neurological variant     of rheumatic fever.      Rheumatic fever is a disorder with a presumed post-streptococcal autoimmune etiology. The     streptococcal pathogenesis of rheumatic fever is supported by studies that have demonstrated     the effectiveness of penicillin prophylaxis in preventing recurrences of this illness. A     trial of penicillin prophylaxis in the PANDAS subgroup demonstrated that penicillin was not     superior to placebo as prophylaxis against GABHS infections in these children, but this     outcome was felt to be secondary to non-compliance with treatment, and there was no decrease     in the number of neuropsychiatric symptom exacerbations in this group. In a study comparing     azithromycin and penicillin, both drugs were completely effective in preventing streptococcal     infections - there were no documented titer elevations during the year-long study period for     children taking either penicillin or azithromycin. Comparable reductions in the severity of     tics and obsessive-compulsive symptoms were also observed. Thus, penicillin was not     performing as an active placebo as originally postulated, but rather provided effective     prophylaxis against Group A beta-hemolytic streptococcal. Both azithromycin and penicillin     appear to be effective in eliminating GABHS infections, and reducing neuropsychiatric symptom     severity; thus, between-group differences are negligible. Since increasing the n to     demonstrate superiority of one prophylactic agent over another would be impractical, we have     amended the study design to address two issues:        1. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo          in prolonging periods of remission among children in the PANDAS subgroup.        2. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo          in improving overall symptom severity for obsessive-compulsive symptoms and tics among          children in the PANDAS subgroup.      Because penicillin has a narrower therapeutic index and is less expensive than azithromycin,     it is the preferable prophylactic agent. Further, penicillin (250 mg orally twice a day) has     a long history of providing safe and effective prophylaxis for rheumatic fever and is the     first line oral therapy recommended by the American Heart Association. Thus, penicillin has     been chosen as the prophylactic antibiotic in the present study. Blister packs are used to     increase compliance and to allow for easier documentation of missed doses.   "
162330|NCT00001360|"     The purpose of this study is to use brain imaging technology to measure changes in blood flow     to areas in the brain as individuals perform intellectual tasks.      This study will use functional magnetic resonance imaging (fMRI) to examine blood flow to     areas of the brain as participants engage in tasks associated with visual perception, visual     recognition, and memory.   "
162403|NCT00002249|"     To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV     infection.   "
195735|NCT00401713|"     The purpose of this study is to evaluate two surgical interventions in patients with AMD.   "
162331|NCT00001361|"     Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the     human body without the use of X-ray (radiation). MRI is especially useful when studying the     brain, because it can provide information about certain brain functions. In addition, MRI is     much better than standard X-rays at showing areas of the brain close to the skull and     detecting changes in the brain associated with neurological diseases. In this study     researchers will use MRI to gather information about the processes that control human     movement and sensory processing.      The purpose of the study is to investigate how the brain is activated when remembering,     thinking, or recognizing objects. Researchers would like to determine what happens to brain     functions when patients have trouble remembering, thinking, or recognizing objects following     the start of disorders in the brain and nervous system. In addition, this study will     investigate the processes of motor control in healthy volunteers and patients with disease.   "
162332|NCT00001362|"     This study is divided into two parts. The first part of the study will use MRI technology to     view the brain structure of patients with neurological disorders and normal volunteers. This     portion of the study will attempt to detect specific areas of damage in the brains of     patients with amnesia and dementia. It will also try to correlate the amount of brain damage     with performance on tests used to measure memory.      In the second part of the study, researchers plan to use MRI technology to study brain     function of patients with neurological disorders and normal volunteers when they perform     tasks. MRI signals during task performance will be used to record areas of the brain     receiving more blood flow indicating increased activity.      Researchers believe this study will help improve existing methods of evaluating patients with     neurological disorders. In addition, this study may contribute information about areas of the     brain involved in thought processing and motor and sensory function.   "
162333|NCT00001363|"     Positron Emission Tomography (PET) is a technique used to investigate the functional activity     of the brain. The PET technique allows doctors to study the normal processes of the brain     (central nervous system) of normal individuals and patients with neurologic illnesses without     physical / structural damage to the brain.      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and     water. Blood carries fuel to the brain and waste products away from the brain. As brain     activity increases blood flow to and from the area of activity increases also. Knowing these     facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of     the brain are receiving more blood flow.      This study will attempt to determine the areas of the brain activated by planning processes     and decision making. Researchers will ask patients to participate in tests and games (chess)     that will stimulate the areas of the brain involved with decision making and planning while     undergoing the water PET blood flow technique.   "
162334|NCT00001364|"     Arteriovenous malformations (AVM) are abnormally formed blood vessels that can be located     throughout the brain and spinal cord. Patients with abnormalities of the blood vessels     located in and around the spinal cord can develop many neurological problems. Some problems     include, weakness, pain, difficulty walking, paralysis, and even death.      The treatment for these AVMs depends on their location, the type of malformation, the area of     the spine involved, and the condition of the patient at the time of treatment. The treatment     is aimed at stopping the neurologic problems from worsening and possibly correcting the     existing problems. There are two commonly used treatments for AVMs, surgery and embolization     (blocking off of blood flow to the AVM).      However, researchers have limited experience treating these conditions because they are rare.     In addition, it has been difficult to classify different kinds of AVMs and to develop new     treatments for them.      This study is designed to increase researchers understanding of AVMs by admitting and     following patients diagnosed with the condition. By increasing the amount of patients studied     diagnosed with spinal blood vessel abnormalities, researchers can begin to develop new     management plans for patients with AVMs.   "
162335|NCT00001365|"     This study is designed to determine whether dextromethorphan, a drug commonly found in cough     medicine, is beneficial and safe for the treatment of Parkinson's disease and other diseases     that might share biochemical abnormalities with Parkinson's disease.      Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This     occurs as a result of destructive changes in an area of the brain responsible for making     dopamine, the basal ganglia. Rhythmical muscular tremors, rigidity of movement, shuffling     footsteps, droopy posture, and a mask-like expression on the face characterize Parkinson's     disease.      Researchers believe that dextromethorphan may be able to safely modify psychomotor function     of patients with Parkinson's Disease.   "
162336|NCT00001366|"     Researchers are interested in studying if magnetic resonance imaging (MRI) is practical for     locating the areas of the brain associated with language in children with epilepsy.      When a region of the brain is active, it uses more fuel in the form of oxygen and sugar     (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and     water. Blood carries fuel to the brain and waste products away from the brain. As brain     activity increases blood flow to and from the area of activity increases also.      Patients participating in the study will be asked to perform tasks designed to test language     skills while undergoing an MRI to detect areas of the brain using oxygen and receiving blood     flow.   "
162337|NCT00001367|"     The goal of this study is to diagnose and follow patients with disorders of movement control.     Patients participating in this study will undergo routine laboratory tests and examinations     in order to monitor their condition.      Doctors at the NIH will work in cooperation with each patient's primary care physician. There     will be no use of investigational treatments in this study.<TAB>   "
162358|NCT00002203|"     The purpose of this study is to compare the safety and effectiveness of taking lamivudine     (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV     combination tablet (Combivir) plus a PI. This study also examines how well patients follow     the dosing schedules for these drugs.      Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV     plus a PI.   "
162359|NCT00002204|"     To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus     (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the     immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.   "
162338|NCT00001368|"     Early studies have shown that the immune system may play a role in the development of     strokes. Conditions such as high blood pressure, high cholesterol, diabetes, and old age can     activate the immune system and increase the risk of developing hardening of the arteries     (atherosclerosis) and damaged blood vessels.      Researchers will attempt to characterize factors that may contribute to atherosclerosis and     stroke by measuring certain components of the immune system, cytokines and leukocyte     activation. Measurements will be taken from patients that are considered to be stroke prone     and from patients without risk factors for the development of stroke. Researchers will     measure the immune system components at the beginning of the study, at six months, and at the     one-year completion of the study.      The study will attempt to determine;      I) If patients with risk factors for stroke have an increased activation of the immune system      II) If patients with risk factors for stroke that are symptomatic have higher levels of     immune system activation compared to patients who do not have symptoms      III) If patients with increased activation of the immune system have accelerated hardening of     the arteries (atherosclerosis)   "
162339|NCT00001371|"     This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2     (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment     base, or the vehicle alone will each be applied four times per day to a single plaque in a     randomized, double-blinded fashion.   "
162340|NCT00001372|"     This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their     relatives to learn more about how the disease develops and changes over time. It will also     study genetic factors that make a person susceptible to SLE.      Patients 10 years of age and older with known or suspected SLE and their relatives may be     eligible for this study. Patients will be evaluated with a medical history and physical     examination, blood and urine tests. Other procedures may include:        1. Electrocardiogram        2. 24-hour urine collection        3. Imaging studies, such as chest and joint X-rays, magnetic resonance imaging (MRI) scans,          bone scans, and bone densitometry.        4. Questionnaire about the degree of disease activity, and survey of risk factors for          disease complications.        5. Apheresis Collection of plasma (fluid portion of blood) or blood cells for analysis.          Whole blood is collected through a needle in an arm vein. The blood circulates through a          machine that separates it into its components. The required component (plasma or cells)          is removed and the rest of the blood is returned to the body through the same needle or          through a second needle in the other arm.        6. Skin biopsy Removal of a small skin sample for microscopic analysis. An area of skin is          numbed with an anesthetic and a small circular portion (about 1/4 inch in diameter) is          removed, using a sharp cookie cutter-type instrument.        7. Kidney, bone marrow or other organ biopsy Removal of a small sample of organ tissue.          These biopsies are done only if they can provide information useful in better          understanding the disease or making treatment decisions.        8. Genetic studies Collection of a blood sample for gene testing.      Patients will be followed at least once a year with a brief history and physical examination     and routine blood and urine tests. Some patients may be seen more often. Treatment     recommendations will be offered to patients' physicians, and patients who are eligible for     other research treatment studies will be invited to enroll.      Participating relatives of patients will fill out a brief medical history questionnaire and     provide a DNA sample (either a blood sample or tissue swab from the inside of the cheek) for     genetic testing.   "
162341|NCT00001373|"     This study is designed to explore the genetics and pathophysiology of diseases presenting     with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome,     and related diseases.      The following individuals may be eligible for this study: 1) patients with known or suspected     familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of     these patients; 3) healthy, normal volunteers 7 years of age or older.      Patients will undergo a medical and family history, physical examination, blood and urine     tests. Additional tests and procedures may include the following:        1. X-rays        2. Consultations with specialists        3. DNA sample collection (blood or saliva sample) for genetic studies. These might include          studies of specific genes, or more complete sequencing of the genome.        4. Additional blood samples a maximum of 1 pint (450 ml) during a 6-week period for studies          of white cell adhesion (stickiness)        5. Leukapheresis for collecting larger amounts of white cells for study. For this          procedure, whole blood is collected through a needle in an arm vein. The blood flows          through a machine that separates it into its components. The white cells are removed and          the rest of the blood is returned to the body through another needle in the other arm.      Patients may be followed approximately every 6 months to monitor symptoms, adjust medicine     dosages, and undergo routine blood and urine tests. They will receive genetic counseling by     the study team on the risk of having affected children and be advised of treatment options.      Participating relatives will undergo a medical and family history, possibly with a review of     medical records, physical examination, blood and urine tests. Additional procedures may     include a 24-hour urine collection, X-rays, and consultations with medical specialists. A DNA     sample (blood or saliva) will also be collected for genetic studies. Additional blood samples     of no more than 550 mL during an 8-week period may be requested for studies of white cell     adhesion (stickiness).      Relatives who have familial Mediterranean fever, TRAPS, or hyper-IgD syndrome will receive     the same follow-up and counseling as described for patients above.      Normal volunteers and patients with gout will have a brief health interview and check of     vital signs (blood pressure and pulse) and will provide a blood sample (up to 90 ml, or 6     tablespoons). Additional blood samples of no more than 1 pint over a 6-week period may be     requested in the future.   "
162342|NCT00001375|"     This study will evaluate patients with inflammatory forms of arthritis within the first year     of onset. The study will attempt to clarify factors that may predict disease course such as     evolution into rheumatoid arthritis (RA) or other chronic inflammatory arthropathies.     Synovial biopsies and synovial fluid will be obtained to search for microbial agents and     other initiating and modulating factors that may be most readily distinguished early in the     disease and to determine the stage of disease at which certain immunologic and hormonal     changes become evident. The study will also search for genetic and other features that may be     associated with specific forms of inflammatory arthropathies that might predict the     subsequent clinical disease course or response to different agents used in treatment of RA,     Reiter's syndrome and other types of chronic inflammatory arthropathies.   "
162343|NCT00001376|"     This study is designed to evaluate blood Th1 and Th2 immunoregulatory cytokine production and     hormonal levels associated with the third trimester of pregnancy and the postpartum state.     Cytokine and hormone levels will be assessed in blood specimens obtained from healthy     pregnant and postpartum females and compared to levels from premenopausal non-pregnant and     non-postpartum females. Blood samples obtained at 30-36 weeks of gestation and 2-6 weeks     postpartum will be the primary study points. Samples will also be obtained from pregnant,     postpartum, and non-pregnant, non-postpartum, premenopausal female patients with rheumatoid     arthritis. Additional data will be generated from samples from normal males, which will be     compared with data from females.      We expect to find that pregnancy is associated with enhanced Th2 cytokine expression and that     the postpartum state is associated with enhanced Th1 cytokine expression. We expect to see     differences in cytokine expression between males and females as well. We seek to gather data     supporting the view that distinct hormonal environments regulate these contrasting     immunological states.   "
162344|NCT00001377|"     The purpose of this study is to identify affected individuals in families with prostate     cancer and to use this information to identify genetic markers closely-linked to the disease     gene.   "
162345|NCT00001378|"     This is a pilot, chemoprevention study. Patients receive fenretinide daily for 25 of every 28     days for 4 months and tamoxifen daily for 23 months, beginning the second month of     fenretinide.      Patients are removed from study for unacceptable toxicity, the development of invasive breast     cancer, or for dysfunctional uterine bleeding.   "
196761|NCT00426660|"     To provide access to maraviroc to patients who have limited or no therapeutic treatment     options and to collect more safety data in a broader patient population.   "
162346|NCT00001379|"     This study will evaluate the response and long-term effects of alpha-interferon in patients     with lymphomatoid granulomatosis (LYG). The disease causes proliferation of destructive cells     involving the lungs, skin, kidneys, and central nervous system.      Patients ages 12 and older who have LYG and who are not pregnant or breast feeding may be     eligible for this study. Alpha interferon or chemotherapy, or both, will be used. Alpha     interferon is a protein the body naturally produces. If patients have grade 3 disease, they     will usually receive EPOCH-rituximab (EPOCH-R) chemotherapy (each letter representing a     drug). If patients have grade 1 or 2 disease, the will usually receive alpha interferon. If     patients have LYG after receiving alpha interferon and/or EPOCH-R, they may receive rituximab     alone or with alpha interferon. Rituximab is an antibody, binding to a specific molecule     (CD20) present on most B-cell lymphomas. Doses of several drugs in EPOCH-R may be increased     if patients tolerated them in the previous cycle. If patients respond to EPOCH-R but still     have low grade LYG, they may receive alpha interferon. Researchers will also try to obtain a     biopsy of patients lesions, to help in understanding the disease.      Patients self-administer alpha interferon by injection under the skin three times weekly.     They will visit the clinic every 2 to 12 weeks for follow-up. Patients will receive alpha     interferon for 1 year after LYG goes away, depending on response. EPOCH-R has these drugs:     rituximab by vein on Day 1; prednisone by mouth on Days 1 to 5; etoposide, doxorubicin, and     vincristine as a continuous intravenous infusion on Days 1 to 5; and cyclophosphamide by     intravenous injection over 1 hour on Day 5. Each cycle lasts 3 weeks: 5 days of chemotherapy     and 16 days of no chemotherapy. Etoposide, doxorubicin, and vincristine are infused through a     small pump worn by patients. The drugs are given over 5 days through a central intravenous     catheter. There are two cycles of EPOCH-R beyond a maximum response, with six cycles minimum.     To reduce harm to bone marrow, patients receive granulocyte colony stimulating factor     (G-CSF), self-administered by injection under the skin daily for approximately 10 days     between chemotherapy cycles. If at the end of therapy, patients have a complete response,     treatment will stop. If there is residual low grade disease, patients may receive alpha     interferon. Alpha interferon can have flu-like side effects of headache, fever, chills, and     body aches. EPOCH-R drugs can cause gastrointestinal problems, hair loss, and weakness. G-CSF     can cause bone pain, body aches, and hair thinning. Chemotherapy can cause some patients to     develop leukemia.      This study may or may not have a direct benefit for participants. It is not certain whether     the new therapy will help decrease tumors. However, knowledge gained may improve the     understanding of and treatment for LYG.   "
162347|NCT00001381|"     Patients with superficial transitional cell carcinoma of the bladder will be treated with     intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered     in this fashion will be evaluated.   "
162348|NCT00001382|"     This trial will evaluate, in patients with metastatic prostate cancer, the tolerability,     toxicities, efficacy, and immunologic effects of repeated vaccinations with a recombinant     vaccinia virus that contains the Prostate Specific Antigen gene (PROSTVAC).   "
162349|NCT00001383|"     This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance     inhibitor PSC 833 given in combination with paclitaxel. Groups of 3 to 6 patients receive     continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days, following paclitaxel     on the first course, then beginning 3 days prior to paclitaxel on subsequent courses.      Stable and responding patients are re-treated every 21 days, with paclitaxel dose adjusted to     maintain an absolute neutrophil count less than 500 for no more than 4 days.   "
162350|NCT00001384|"     This is a pilot feasibility trial of AC (Adriamycin, cyclophosphamide) chemotherapy with     G-CSF (filgrastim) followed by infusional Taxol (paclitaxel) as adjuvant treatment for     patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in     duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3     fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to     assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed     by infusional paclitaxel in 14 day cycles.   "
162351|NCT00001385|"     This is a prospective study evaluating the role of Positron Emission Tomography (PET scan) in     breast cancer. The radiopharmaceutical [18F] 2-deoxyglucose will be used as both an imaging     modality and to evaluate tumor metabolism in patients with breast cancer. Patients with stage     II, stage IIIA or IIIB, or stage IV breast cancer and evaluable disease in the breast and/or     at metastatic sites will be studied. Patients will be injected intravenously with     [18F]2-deoxyglucose and a PET scan conducted over 90 minutes. Examination of the role of PET     scan in assessing the response of breast cancer to chemotherapy, especially in stage II and     stage III patients, will be done. Up to three PET scans within one year may be performed.     Findings by PET scan will be correlated both with those of concurrent imaging techniques     (x-ray, CT scan, MRI, bone scan or mammogram), and with histologic, biochemical, and flow     cytometric information on the tumor, and with findings in subsequent surgical specimens.     Changes in tumor glucose metabolism with treatment will be assessed by PET imaging studies     and by biochemical methods when possible.   "
162373|NCT00002218|"     To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To     determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess     the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination     therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral     agents.   "
162374|NCT00002219|"     The purpose of this study is to see if it is safe and effective to give adefovir (a new     anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other     anti-HIV medications.   "
162352|NCT00001386|"     Synthetic HIV Peptide Vaccines (Treatment Protocol)      We are conducting a study to evaluate the safety of two peptide vaccines (given alone or in     combination) in patients with early HIV infection. Patients entered onto the study must have     >500 CD4 cells/mm(3) and have preserved cardiac, hepatic, renal, and bone marrow function.     Patients must be off all anti-retroviral therapy for at least 6 months and may not have     received any experimental HIV vaccines. The vaccines being testing in this trial are     comprised of short peptide segments of the HIV envelope, including the V3 loop. In animal     studies, the peptides were able to induce neutralizing antibodies as well as cytotoxic T     responses to HIV. This will be the first trial in which they are given to humans. The study     will last for approximately one year, during which time the volunteers will receive 6 peptide     vaccines under the skin. For more information, please call Tino Merced-Galindez, R.N. at     (301) 496-8959 or Dr. Richard Little at (800) 772-5464.   "
162353|NCT00002198|"     The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain     alcohol) when they are given together.   "
162354|NCT00002199|"     To compare the safety, tolerance, early antiviral activity, and durability of antiviral     response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir     (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the     occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and     the development of plasma viral genotypic and phenotypic resistance.   "
162355|NCT00002200|"     The purpose of this study is to see if it is safe and effective to give 1592U89 to     HIV-positive adults. This study also examines the influence previous anti-HIV treatment has     on the effectiveness of 1592U89.   "
162356|NCT00002201|"     The purpose of this study is to see if it is safe and effective to give ritonavir plus     nelfinavir to HIV-infected patients. This study will also see how ritonavir and nelfinavir     are absorbed by the body and how they affect the level of HIV in the blood.   "
162357|NCT00002202|"     The purpose of this study is to see if 141W94 is as safe and effective as indinavir when used     with nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks. This study also     examines what effect other drugs have on how the body handles 141W94.   "
162360|NCT00002205|"     To assess the safety, tolerance, and efficacy of amprenavir (APV) plus abacavir (ABC) in     patients who have previously failed antiretroviral treatment containing a protease inhibitor     (PI). To provide open-label, pre-approval access to APV for adults and adolescents with HIV-1     infection and limited treatment options.      This study is being conducted to provide open-label APV to patients in danger of HIV disease     progression, as well as those who may benefit beyond the expected outcomes of current     anti-retroviral therapies. Despite unapproved status, APV may prove highly efficacious in     combatting HIV progression and may help those in need, prior to regulatory approval.   "
162361|NCT00002206|"     The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil     once a day for 4 weeks to HIV-infected patients who never have been treated with anti-HIV     medicine. This study also examines how the body processes adefovir dipivoxil.   "
162362|NCT00002207|"     The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a     day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This     study also examines the safety of giving ddI with d4T in the short-term.   "
162363|NCT00002208|"     To demonstrate that the antiviral activity and safety/tolerability of a test regimen of     indinavir is equivalent to that of a control regimen of indinavir when each is coadministered     with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease     inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state     pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other,     for both the control and test regimen groups.   "
162364|NCT00002209|"     The purpose of this study is to see if it is safe to give multiple doses of CPI-1189 to     HIV-infected, otherwise healthy, males. The study will also look at how CPI-1189 affects the     levels of HIV, T cells (cells in the body that help fight infection), and three anti-HIV     drugs (zidovudine, lamivudine, and indinavir) in the blood.      Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to losses of     memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.   "
162365|NCT00002210|"     The purpose of this study is to see if it is safe and effective to give delavirdine mesylate     (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to HIV-infected     children and babies. This study also examines how the body processes Rescriptor when taken     with 2 NRTIs.   "
162366|NCT00002211|"     The purpose of this study is to see if it is safe and effective to give combinations of three     or four anti-HIV drugs to HIV-infected patients. The drugs used in this study are delavirdine     (DLV), nelfinavir (NLF), didanosine (ddI), and stavudine (d4T).   "
162367|NCT00002212|"     The purpose of this study is to see if it is safe and effective to give Targretin capsules to     patients with AIDS-related Kaposi's sarcoma (KS).   "
162368|NCT00002213|"     The purpose of this study is to see if it is safe and effective to give 1592U89 plus 141W94     plus DMP 266 to patients with HIV who have developed resistance to indinavir, ritonavir,     saquinavir, or nelfinavir after at least 20 weeks of protease inhibitor treatment. This study     also examines how long this combination therapy is effective before patients develop     resistance to it.   "
162369|NCT00002214|"     To assess the toxicity profile and determine the maximum tolerated dose (MTD), if possible,     of S-1153 administered orally 3 times daily for 14 days. To investigate the clinical     pharmacokinetic parameters for S-1153. To assess anti-HIV activity associated with S-1153     administration through evaluation of CD4 and viral load measurements.   "
162370|NCT00002215|"     To compare the proportion of patients whose plasma HIV-1 RNA level falls and remains below     the limit of quantification by the Roche Amplicor Monitor (400 copies/ml)[AS PER AMENDMENT     8/4/98: 50 copies/ml] between weeks 0 and 24. To determine the short-term safety and     tolerability of MKC-442 plus nelfinavir (Viracept) plus dual nucleoside analogs. To determine     the time to viral failure and time to tolerability failure through Week 48 of therapy.   "
162371|NCT00002216|"     The purpose of this study is to compare 2 combination drug therapies in HIV-infected patients     who have never received anti-HIV treatment.   "
162375|NCT00002220|"     The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz     plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients     who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of     patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks     of treatment.   "
162376|NCT00002221|"     The purpose of this study is to see if it is safe and effective to use gene therapy to treat     non-Hodgkin's lymphoma (NHL) in HIV-positive patients.      Stem cell transplantation is a procedure used to treat NHL. Stem cells are very immature     cells that develop to create all of the different types of blood cells. In this study, some     of your stem cells will be treated with gene therapy, meaning the cells are treated with a     virus that does not cause disease. Some cells will receive a virus that contains ribozymes,     enzymes that may help fight HIV. Other cells will be treated with a virus that does not     contain ribozymes to see how the virus works alone. Some cells will not be treated at all.     Doctors would like to see whether giving patients stem cells with ribozymes can treat NHL and     stop HIV from growing at the same time.   "
162377|NCT00002222|"     The purpose of this study is to see if valganciclovir is a safe treatment for CMV retinitis     in patients who have been treated for this condition in the past. This study also examines     the effectiveness of valganciclovir in preventing the recurrence of CMV retinitis.   "
162404|NCT00002250|"     To test the effectiveness of recombinant human CD4 Immunoglobulin G (CD4-IgG) in the     treatment of HIV-associated immune thrombocytopenic purpura in patients with all levels of     HIV infection.   "
162379|NCT00002224|"     Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a     new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and     hopefully will prevent stomach upset. The purpose of this study is to compare the     effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with     stavudine (d4T) plus nelfinavir (NLF).   "
162380|NCT00002225|"     The purpose of this study is to see if it is safe and effective to give efavirenz plus     stavudine plus didanosine to HIV-infected patients who have never received anti-HIV     treatment.   "
162381|NCT00002226|"     The purpose of this study is to see if it is safe and effective to give SU5416 to     HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth     of KS tumors.   "
162382|NCT00002227|"     The purpose of this study is to see if it is safe and effective to give efavirenz plus     stavudine plus lamivudine to patients who have never taken anti-HIV drugs.   "
162383|NCT00002228|"     The purpose of this study is to see if it is safe and effective to give T-20 to HIV-positive     adults. T-20 is an anti-HIV drug.   "
162384|NCT00002229|"     The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft     gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.   "
162385|NCT00002230|"     To determine the virologic benefits associated with the addition of hydroxyurea (HU) to     combination drug therapy with didanosine (ddI), stavudine (d4T), and efavirenz (DMP) in     HIV-infected patients. To assess the safety and tolerance of this regimen, with or without     HU.   "
162386|NCT00002231|"     The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to     HIV-negative volunteers. This study will also look at how this vaccine affects the immune     system of these volunteers.   "
162387|NCT00002232|"     The purpose of this study is to see if it is safe to give GENEVAX-HIV, a potential HIV     vaccine, to HIV-negative volunteers. The study also compares the effects of GENEVAX-HIV     injected into the muscle to the effects of the drug when injected into the skin.   "
162388|NCT00002233|"     The purpose of this study is to see if it is safe to give a combination of four anti-HIV     drugs to patients recently infected with HIV who have never received anti-HIV treatment. The     effects of this combination of drugs on the immune system and the level of HIV in the body     are studied also. The four-drug combination includes lamivudine, abacavir, amprenavir, and     indinavir.   "
162389|NCT00002234|"     The purpose of this study is to see if it is safe and effective to give HIV-infected patients     a new combination of anti-HIV drugs taken once daily.   "
162390|NCT00002235|"     Indinavir is usually taken three times a day. The purpose of this study is to see if it is     safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a     day) and efavirenz (taken once a day).   "
162391|NCT00002236|"     The purpose of this study is to see whether it is better to take delavirdine (DLV) plus     indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.   "
162392|NCT00002237|"     The purpose of this study is to determine the highest amount of peldesine that is safe. This     study will also see if this amount of peldesine is effective in lowering HIV levels in the     blood.   "
162393|NCT00002238|"     To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS     related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen.   "
162394|NCT00002239|"     The purpose of this study is to see if it is safe and effective to give T-20, a new type of     anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are     abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses     of T-20 are tested.   "
162395|NCT00002240|"     The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This     drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The     effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a     protease inhibitor that is already commonly prescribed.   "
162396|NCT00002241|"     The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus     stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV     in the blood.   "
162397|NCT00002243|"     The purpose of this study is to test the safety and effectiveness of a new non-nucleoside     reverse transcriptase inhibitor (NNRTI), (+)-calanolide A, in HIV-positive patients who have     never received anti-HIV treatment.   "
162398|NCT00002244|"     The purpose of this study is to see if it is safe and effective to give WF10 to adults with     late-stage HIV disease. WF10 is suspected to help the immune system fight infection and slow     HIV disease progression.   "
162399|NCT00002245|"     The purpose of this study is to evaluate the effects of a 3-drug anti-HIV regimen, amprenavir     (APV) plus abacavir (ABC) plus lamivudine (3TC), on the way carbohydrates (sugars) and fats     are metabolized (processed by the body) in HIV-infected patients who have received little or     no previous anti-HIV drug therapy.   "
162400|NCT00002246|"     The purpose of this study is to see if adding stavudine (d4T) to anti-HIV drug regimens (with     or without zidovudine, ZDV) can improve symptoms of AIDS Dementia Complex (ADC, problems     involving the brain or spinal cord) in HIV-positive patients.   "
162401|NCT00002247|"     To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a     single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy. To     compare the time to progression of cytomegalovirus (CMV) retinitis between two regimens of     oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy. To     describe the efficacy and safety of double dose versus single dose oral ganciclovir in     patients who have a progression of retinitis while on the originally assigned maintenance     treatment. To describe the safety, tolerance, and time to progression of retinitis during the     52 weeks of oral ganciclovir maintenance therapy in people with AIDS. To describe the safety     and tolerance of oral ganciclovir maintenance therapy when given concurrently with     antiretroviral treatment (e.g., zidovudine, ddI, or ddC). To describe survival of people with     AIDS and CMV retinitis.   "
162402|NCT00002248|"     PRIMARY: To assess the effect of bovine anti-Cryptosporidium immunoglobulin (BACI) on the     volume of diarrhea due to Cryptosporidium parvum in AIDS patients who have protracted     Cryptosporidium enteritis.      SECONDARY: To assess changes in stool consistency and frequency, body weight, and safety in     this patient population.   "
162406|NCT00002252|"     To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in     controlling diarrhea which is a manifestation or complication of documented HIV infection and     which is refractory (does not respond) to all known treatment classes.   "
162407|NCT00002253|"     The primary objective of this study is to determine the relapse rate in patients with     AIDS-related diarrhea who were found to be Responders in a previous placebo-controlled,     double-blind study of Sandostatin (Study #D203 - FDA 102A).      The secondary objectives include: 1) To evaluate clinical efficacy and safety of open-label     Sandostatin in patients who were Non-Responders in Study #D203 - FDA 102A; 2) To evaluate     the efficacy and safety of Sandostatin during prolonged open-label treatment in Responders     from Study #D03 - FDA 102A.   "
162408|NCT00002254|"     To assess the tolerance and toxicity profile of deoxy-3'-fluorothymidine (FLT) after multiple     oral dosing for 16 weeks. To characterize the steady-state pharmacokinetics of FLT after     multiple oral doses. To assess the effect of FLT on immunologic and virologic markers of HIV     infection (CD4+ lymphocyte count, p24 antigen, viremia) in patients with AIDS or AIDS related     complex (ARC) after multiple oral dosing for 16 weeks.   "
162409|NCT00002255|"     To evaluate the safety, tolerance, and biological activity of filgrastim (recombinant     granulocyte colony stimulating factor; G-CSF) given by daily subcutaneous injection prior to     and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or     severe ARC. To evaluate the safety, tolerance, and biological activity of recombinant EPO     given three times weekly by subcutaneous injection concomitantly with G-CSF and prior to and     concomitantly with AZT in patients with AIDS or severe ARC. To study the safety and tolerance     of three dose levels of AZT given concomitantly with G-CSF and EPO in patients with AIDS or     severe ARC. To study the effects of G-CSF on neutrophil function and number in patients with     AIDS or severe ARC. To study the effect of G-CSF alone and in combination with EPO on HIV     replication in vivo as measured by circulating HIV p24 antigen, plasma HIV viremia, and     semiquantitative HIV cocultures.   "
162410|NCT00002256|"     To provide zalcitabine ( ddC ) for patients with AIDS or Advanced ARC in whom zidovudine (     AZT ) is contraindicated, or who have failed treatment with or are intolerant to AZT and to     demonstrate that ddC monotherapy is safe, and tolerable in this patient population.   "
162411|NCT00002257|"     To compare the time to progression of CMV retinitis between oral ganciclovir and IV     ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of     oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To     describe the safety and tolerance of oral ganciclovir treatment when given concurrently with     anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with     AIDS and CMV retinitis.   "
162412|NCT00002258|"     To determine the safety, tolerability and maximum tolerated dose of SDZ ILE 964 administered     by daily subcutaneous injections in patients infected with human immunodeficiency virus (HIV)     who have cytopenias (low blood cell counts). To obtain information about the biologic effects     of SDZ ILE 964 administration in improving blood counts in HIV-infected patients. To obtain     information about the effects of SDZ ILE-964 administration on both parameters of HIV     replication and on residual immunologic function.   "
162413|NCT00002259|"     To study the toxicity and efficacy of IV mitoxantrone hydrochloride (Novantrone) in     AIDS-related Kaposi's sarcoma.   "
162414|NCT00002260|"     To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation)     after single doses in both the fed and fasting states; to assess the effect of food on the     oral bioavailability of FLT   "
162415|NCT00002261|"     To determine the physiological and immunological responses in healthy HIV seronegative adult     volunteers vaccinated with a) the HIVAC-1e (vaccinia-HIV) vaccine expressing the envelope     glycoproteins of HIV and b) the Wyeth smallpox vaccine. The parameters to be studied will     include:        1. The course of physiological responses to vaccination, including (a) lesion development,          progression, and resolution; (b) physiological changes such as temperature, malaise,          itching at the site, etc. and (c) any observable AE.        2. The appearance, identity, quantity, and duration of humoral antibodies against HIV and          vaccinia virus.        3. The appearance, identity, quantity, and duration of cell-mediated immunity against HIV          and vaccinia virus.        4. The adequacy of a procedure using a special dressing to contain viral shedding from the          vaccination site.        5. The safety, humoral and cellular immune responses of a booster injection of the          recombinant subunit gp160 vaccine (MicroGeneSys) in HIVAC-1e recipients.   "
162430|NCT00002276|"     To determine if platelet dysfunction and/or pharmacologic drug interaction occurs in patients     taking both AZT and ibuprofen, which might account for enhanced bleeding tendency.   "
162416|NCT00002262|"     To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of     intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated     dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF     injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance     spectroscopy.   "
162417|NCT00002263|"     To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage     colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in     HIV-infected children who have developed granulocytopenia as a result of continuous     intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of     concomitant GM-CSF on other hematologic parameters. To assess the potential therapeutic     benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated     infectious complications.   "
162418|NCT00002264|"     To examine the efficacy of cow's milk immune globulin in the treatment of diarrhea due to     chronic intestinal cryptosporidiosis in patients with AIDS. The secondary end points of the     study involve functional improvement which will be determined from nutritional and absorption     studies.   "
162435|NCT00002281|"     To evaluate the safety, tolerance and biological activity of filgrastim (granulocyte     colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and     concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe     AIDS related complex (ARC). To evaluate the safety, tolerance, and biological activity of EPO     given 3 times weekly by SC injection concomitantly with G-CSF and prior to and concomitantly     with AZT in patients with AIDS or severe ARC. To study the safety and tolerance of 3 dose     levels of AZT given to patients with AIDS or severe ARC concomitantly treated with G-CSF and     EPO. To study the effect of G-CSF alone and in combination with EPO on HIV replication in     vivo as measured by circulating HIV p24 antigen, plasma HIV viremia and semiquantitative HIV     cocultures.   "
162419|NCT00002265|"     To demonstrate that zalcitabine (dideoxycytidine; ddC) monotherapy is safe and tolerable in     the treatment of patients with AIDS or advanced AIDS related complex (ARC) who previously     demonstrated intolerance to zidovudine (AZT) treatment while in Protocol N3300 (NIAID ACTG     114) or N3492 (NIAID ACTG 119).      NOTE OF CAUTION FOR CONCOMITANT MEDICATIONS ON STUDY:      Patients on amphotericin, pyrimethamine, sulfadiazine, trimethoprim/sulfamethoxazole,     ganciclovir, intravenous pentamidine, intravenous acyclovir or oral acyclovir or other bone     marrow or renal toxic drugs may not tolerate concomitant ddC. If these drugs are given     concomitantly with ddC, patients should have frequent clinical and laboratory assessments, as     appropriate. Drugs that are nephrotoxic or have the potential to cause peripheral neuropathy     might be expected to cause increased toxicity when co-administered with ddC. Drugs that could     cause serious additive toxicity when co-administered with study medication will be allowed     for treatment of an acute intercurrent illness or opportunistic infection at the discretion     of the investigator. Their use may be allowed with interruption of study drug for up to 35     days per episode, for a total of 90 days for the study. If the patient's condition requires     chronic administration of these medications, the patient will be discontinued from study     medication and followed.   "
162420|NCT00002266|"     To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times     per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or     AIDS related complex (ARC) patients.   "
162421|NCT00002267|"     The primary objective of this trial is to assess the safety and the relative benefit of     rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex     (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to     placebo, and to assess if survival is prolonged in patients who receive rifabutin     prophylaxis.   "
162422|NCT00002268|"     To determine the safety, tolerance, and potential in vivo antiviral effects of five dosage     levels and a dose to be determined of human anti-cytomegalovirus (CMV) monoclonal antibody     (SDZ MSL-109; formerly SDZ 89-109) when administered once every 2 weeks for a total of 12     doses to patients with either AIDS or eligible AIDS-related complex (ARC) and with culture     proven evidence of CMV viremia and/or viruria. Sandoglobulin will be employed as a     comparative control.   "
162423|NCT00002269|"     To evaluate ampligen at two dosage levels given twice weekly in combination with zidovudine     (AZT) versus AZT alone in individuals with HIV-related immune dysfunction defined as T4 count     between 100 and 300 cells/mm3.   "
162424|NCT00002270|"     To study the effectiveness of alpha interferon (IFN-A2b) and zidovudine (AZT) in treating     progressive multifocal leukoencephalopathy (PML) as a complication of HIV-1 infection.   "
162425|NCT00002271|"     To characterize the pharmacokinetics of orally administered 3'-deoxy-3'-fluorothymidine     (FLT), in a liquid formulation, after single doses in asymptomatic HIV-infected patients and     to assess the safety and tolerance of the single oral doses of FLT.   "
162426|NCT00002272|"     To evaluate the safety and efficacy of intermittent intravenous (IV) foscarnet in the     treatment of acyclovir-resistant herpes simplex virus (HSV) infections in AIDS patients and     other immunocompromised patients. To evaluate the necessity, efficacy, and safety of IV     maintenance foscarnet therapy in preventing recurrent disease. To confirm the     pharmacokinetics of intermittent induction and maintenance IV regimens.   "
162427|NCT00002273|"     To attempt to demonstrate the efficacy of ganciclovir (DHPG) treatment of cytomegalovirus     (CMV) colitis in AIDS patients by evaluating both clinical and virologic parameters. To     determine acceptability and the safety profile of a 2-week course of intravenous (IV) DHPG     therapy.   "
162428|NCT00002274|"     The objective of this open-label study regimen is to make didanosine (ddI) available to     patients with AIDS who are clinically deteriorating on zidovudine (AZT) and cannot enter the     Phase II ddI programs due to protocol exclusion or geographic location.   "
162429|NCT00002275|"     The objectives of this study are:      To establish whether there is a difference in clinical effectiveness of Liposyn II 20 percent     as compared with Liposyn III 2 percent in AIDS patients with Pneumocystis carinii pneumonia     (PCP). To compare the effects of the two lipid emulsions on immunologic function in AIDS     patients. To compare the effect of the two lipid emulsions on HIV load in AIDS patients as     measured by reverse transcriptase (RT) in culture. To determine whether a decrease in HIV     infectivity is greater in patients given a parenteral feeding regimen containing Liposyn II     20 percent or Liposyn III 2 percent.   "
162431|NCT00002277|"     To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment     for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal     infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS     related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they     also have a malignancy.   "
162432|NCT00002278|"     To evaluate the safety and efficacy of diclazuril capsules as a treatment for cryptosporidial     related diarrhea in AIDS patients who have been treated in the double-blind study # JRD     64,433/1101 and have relapsed, or de-novo patients who have been diagnosed with     cryptosporidial related diarrhea and who meet the inclusion and exclusion criteria of this     protocol.   "
162433|NCT00002279|"     AMENDED: To provide ddC for patients with AIDS or advanced ARC who have failed treatment     with, are intolerant to or are ineligible to receive zidovudine (AZT) and to demonstrate that     ddC monotherapy is safe, and tolerable in this patient population.      Original design: To provide zalcitabine (dideoxycytidine; ddC) for patients with AIDS or     advanced AIDS-related complex (ARC) who have failed treatment with or are intolerant to     zidovudine (AZT) and who are also intolerant to dideoxyinosine (ddI); to demonstrate that ddC     monotherapy is safe and tolerable in the treatment of patients who previously experienced     either treatment failure, hematologic intolerance or myositis with AZT treatment and     pancreatitis or other toxicities (except peripheral neuropathy with ddI).   "
162434|NCT00002280|"     The purpose of this study is to make didanosine (ddI) available to children with AIDS who are     clinically deteriorating on zidovudine (AZT) or intolerant to AZT and cannot enter the Phase     II ddI programs due to protocol exclusion or geographic location.   "
162437|NCT00002283|"     Evaluate the effectiveness rate of dapsone plus trimethoprim as a therapy for the first     episode of Pneumocystis carinii pneumonia (PCP) in AIDS patients. Compare the rates and     severity of adverse effects using dapsone versus trimethoprim - sulfamethoxazole (TMP /     PurposeX). Establish relative toxicities with regard to suitability for outpatient treatment.   "
162438|NCT00002284|"     To determine whether zidovudine (AZT) in conjunction with bone marrow transplantation     prevents the reinfection of donor hematopoietic/lymphoid cells in patients with positive HTLV     III antibody and large cell/diffuse histiocytic lymphoma. Patients who are candidates will be     evaluated for HTLV III activity and drug levels.   "
162439|NCT00002285|"     To determine the safety and efficacy of zidovudine (AZT) treatment combined with syngeneic or     HLA identical allogeneic lymphocyte transfer in the presence of interleukin 2 (IL-2) as a     treatment for AIDS. Patients with documented HIV viremia will be evaluated. Effects on virus     replication, immune function, and clinical condition will be monitored with periodic virus     cultures, estimates of lymphocyte type and numbers, cell surface markers, in vitro lymphocyte     responses and frequent clinical evaluations.   "
162440|NCT00002286|"     To evaluate the feasibility of Retrovir (AZT) in the treatment of psoriasis in HIV antibody     positive patients. Retrovir has been shown to be effective in the treatment of AIDS. In     addition, the administration of AZT appears to have induced a remission of psoriasis in one     case study. In light of AZT's antiviral activity and potential effectiveness as an agent for     the treatment of psoriasis, this would be the most likely treatment for HIV positive,     psoriatic patients whose disease progresses quickly.   "
162441|NCT00002287|"     To evaluate the safety and effectiveness of Retrovir (AZT) when used as prophylaxis for     health care workers at risk for HIV infection from exposure to HIV-contaminated blood or     blood components.   "
162442|NCT00002288|"     To assess the efficacy of Retrovir (AZT) therapy in the treatment of HIV Ab positive persons     with impairments in neuropsychological functioning. To assess the safety, virologic, and     immunologic effects of AZT therapy in HIV Ab positive persons with neuropsychological     impairment but minimal other symptomatology.   "
162443|NCT00002289|"     Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus     isolation. Examine the ability of thymopentin to stimulate the immune system and alter the     clinical findings in patients infected with HIV who do not yet have AIDS.   "
162444|NCT00002290|"     This double-blind, placebo-controlled study is designed to determine the long-term safety and     efficacy of concurrent oral Retrovir / Zovirax (AZT and ACV) therapy and oral AZT therapy     alone, in the treatment of early symptomatic HIV infection. Efficacy will be evaluated by     monitoring the incidence, severity, and time of development of opportunistic infections and     other manifestations of advanced symptomatic HIV infection. The effects of the combination     and single AZT therapy on immune function and viral replication will also be evaluated. Study     participants will be monitored for evidence of toxicity or intolerance to concurrent AZT /     ACV administration and AZT therapy alone.   "
162445|NCT00002291|"     To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of     1 of 3 doses of aerosol pentamidine when used as a prophylactic agent in patients who have     recovered from their first episode of AIDS-associated Pneumocystis carinii pneumonia (PCP).   "
162446|NCT00002292|"     To compare parenteral versus inhaled pentamidine in patients with documented Pneumocystis     carinii pneumonia (PCP) with AIDS.   "
162447|NCT00002293|"     To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the     prophylaxis of oral candidiasis in patients with AIDS or AIDS related syndromes (group III or     IV, CDC classification)   "
162448|NCT00002294|"     To compare the safety and effectiveness of fluconazole with that of placebo as maintenance     treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.   "
162449|NCT00002295|"     To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to:      Laboratory (immunologic defects):        -  Comparison of total helper and suppressor T-cell numbers among the groups.        -  Comparison of changes in natural killer cell activity.        -  Comparison of other laboratory findings among the groups.      Clinical changes:        -  Comparison of the frequency of opportunistic infections among the groups.        -  Comparison of the frequency of the development of AIDS-related malignancies.        -  Comparison of other clinical manifestations relative to severity and time of onset.   "
162482|NCT00002328|"     To provide azithromycin for the treatment of individual patients with proven     cryptosporidiosis whose disease has persisted or progressed despite prior therapies.   "
162450|NCT00002296|"     The objective of this Phase III, randomized, double-blind, placebo-controlled study in     patients with immunologic deficiency is to determine the effect of Isoprinosine in producing     an immuno-restorative response within the study observation period (including the 2-month     period following cessation of the 28 days of treatment), measured by one or more of the     following immunological parameters:        -  Increase in natural killer (NK) cell activity.        -  Increase in total T-cells (OKT-11).        -  Increases in absolute number and percentage of T-helper cells (OKT-4).   "
162451|NCT00002297|"     The objectives of this study are to determine the effects of isoprinosine in patients     diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will     include:      Signs and symptoms:        -  Lymphadenopathy.        -  Fever.        -  Weight loss.        -  Occurrence of opportunistic infections.      Cell-mediated immune system parameters:        -  T-helper cell (OKT4) numbers and proportions.        -  T-suppressor cell (OKT8) numbers and proportions.        -  Natural killer (NK) cell activity.        -  Lymphocyte blastogenic response to phytohemagglutinin (PHA).        -  Lymphocyte blastogenic response to pokeweed mitogen (PWM).        -  Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.        -  Circulating immune complexes. Infections characteristically associated with AIDS, such          as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex,          Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium-          intracellulare, Legionella, and Isospora.      Safety parameters:        -  Blood chemistry including serum uric acid (PurposeA-12).        -  Complete blood count (CBC).        -  Platelet count.   "
162469|NCT00002315|"     To determine the efficacy of oral 882C87 compared with oral acyclovir in the treatment of     localized herpes zoster in immunocompromised patients. To assess the safety and tolerance of     oral 882C87 in immunocompromised patients.   "
176038|NCT00144612|"     An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of     MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP   "
162452|NCT00002298|"     The objective of this clinical trial is to determine whether long-term oral dosage of     ribavirin delays development of symptomatic HIV disease in HIV antibody positive subjects who     are completely asymptomatic (CDC classification group II), who have only the lymphadenopathy     syndrome (CDC classification group III), or who have clinical symptoms but not severe HIV     disease as defined by CDC classification, and whether the dosage regimen is safe and     tolerable in these subjects.   "
162453|NCT00002299|"     The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of     cytomegalovirus retinitis in patients with AIDS. While early clinical trials have shown that     30 mg/kg/week of DHPG is usually sufficient to delay or prevent relapse, neutropenia is a     common dose-limiting problem in about 50 percent of patients. Since in vitro data have     suggested that there is synergism between DHPG and interferon beta against cytomegalovirus, a     reduced dose of DHPG in combination with a low dose of interferon beta may prevent relapse     without causing neutropenia. If remission can be maintained with low-dose DHPG and interferon     beta, maintenance therapy with a moderate dose of interferon beta alone will be evaluated in     a subsequent protocol.   "
162454|NCT00002300|"     To compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia,     calorie intake, and nutritional parameters of patients with a confirmed diagnosis of AIDS. To     characterize dose response in relation to weight gain. To determine whether megestrol acetate     relative to placebo improves the perception of well-being among AIDS patients with cachexia.     To evaluate megestrol acetate's effect on immune function via skin test reactivity, T4/T8     ratio, and total lymphocytes.   "
162455|NCT00002301|"     To evaluate the safety and efficacy of foscarnet induction treatment of cytomegalovirus (CMV)     retinitis in AIDS patients who have previously suffered severe dose-limiting     ganciclovir-related myelosuppression, who are ineligible for ganciclovir treatment due to     myelosuppression or who have clearly failed to have a therapeutic response to ganciclovir     therapy. To assess the duration of clinical response. To evaluate the effect on quantitative     CMV cultures of blood and urine. To determine the effect on recovery of HIV p24 antigen     capture direct from plasma.   "
162456|NCT00002302|"     To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS     patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.     Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.   "
162457|NCT00002303|"     To determine the safety and efficacy of erythropoietin administered to patients with AIDS or     advanced AIDS related complex ARC and anemia.   "
162458|NCT00002304|"     To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the     treatment of candidal esophagitis in immunocompromised patients.   "
162459|NCT00002305|"     To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in     combination with flucytosine, as treatment for acute cryptococcal meningitis.   "
162460|NCT00002306|"     To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal     meningitis in patients who have had an unsatisfactory response to or have experienced     unacceptable toxicity with amphotericin B.   "
162461|NCT00002307|"     To compare stavudine (d4T) and zidovudine (AZT) in slowing the progression of HIV disease. To     compare the antiviral activity of d4T versus AZT as measured by plasma levels of p24 antigen     and HIV viremia, and their relative efficacy by improvement and/or absence of adverse changes     over time in laboratory parameters associated with HIV infection. To compare the safety of     oral doses of d4T to AZT in patients with HIV infection.   "
162462|NCT00002308|"     To make stavudine (d4T) available to patients with advanced HIV disease for whom no     alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose     levels in a twice-daily regimen.   "
162463|NCT00002309|"     To evaluate the efficacy and safety of azithromycin administered once a week in the     prevention of disseminated Mycobacterium avium complex (MAC) in severely immunocompromised     HIV-infected patients with a CD4 count < 100 cells/mm3.   "
162483|NCT00002329|"     To characterize the safety profile of MDL 28574A following both acute and subchronic dosing     in HIV-positive patients. To determine the MTD of both acute and subchronic doses of this     drug when administered as oral solution. To determine the pharmacokinetic profile of MDL     28574A and castanospermine (from which MDL 28574A is derived) following both acute and     subchronic dosing.   "
162464|NCT00002310|"     To evaluate the safety and tolerance of topically applied SP-303T in AIDS patients. To     observe the effect of this drug on herpes simplex virus lesions in patients who have failed     to heal in response to oral or intravenous acyclovir therapy.      The lack of alternative treatments for herpes simplex virus infection in patients with AIDS     and the development of resistance to acyclovir for patients requiring repeated treatment     presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against     resistant strains and offers a convenient and inexpensive means of drug administration in     comparison to the use of intravenous medication.   "
162465|NCT00002311|"     To study the safety and efficacy of four different doses of Wobenzym (an enzyme combination     consisting of pancreatin, papain, bromelain, trypsin, lipase, amylase, chymotrypsin, and     rutin) in patients with HIV infection whose CD4 count is between 250 and 400 cells/mm3. To     evaluate the effect of Wobenzym on certain surrogate markers associated with progression of     HIV disease.   "
162466|NCT00002312|"     To evaluate the pharmacokinetics, safety, and tolerance of delavirdine mesylate ( U-90152 )     after multiple doses given orally to asymptomatic HIV-1 positive patients who are maintained     on a stable dose of zidovudine ( AZT ). To investigate the optimum dose regimen of U-90152     that gives average trough concentrations > 1 micromolar in combination with standard AZT     therapy, and to examine drug interactions between the two drugs. To establish the MTD of     U-90152 in HIV-1 positive patients on stable AZT therapy. To investigate comparative     pharmacokinetics between HIV-1 positive men and women.   "
162467|NCT00002313|"     To evaluate the clinical toxicity, safety, and potential anti-HIV activity of intravenous     nystatin in patients with HIV infection who have completed protocol FDA 103C. To evaluate the     safety and potential antiviral activity of intravenous nystatin and oral didanosine (ddI)     administered in an alternating regimen in this patient population.   "
162468|NCT00002314|"     To study the effects of Ro 24-7429 on tumor growth in patients with HIV-related Kaposi's     sarcoma. To study the safety and tolerance, effects on HIV replication, and immunologic     effects of Ro 24-7429 in this patient population. To explore relationships between exposure     to Ro 24-7429 and its metabolites with its antitumor and antiviral activities and drug     toxicity.   "
162491|NCT00002337|"     To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with     advanced HIV disease.   "
162470|NCT00002316|"     To evaluate the safety of escalating doses of RMP-7 administered in persons with HIV     infection and cryptococcal meningitis and to determine the MTD of the drug. To evaluate the     pharmacokinetics, including cerebrospinal fluid (CSF) penetration, of amphotericin B when     administered with RMP-7.   "
162471|NCT00002317|"     To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in     pediatric patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have     demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or     parenteral pentamidine).   "
162472|NCT00002318|"     To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the     treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established     therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and     tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.   "
162473|NCT00002319|"     To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride     (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who     previously had good responses to DOX-SL in controlled studies of limited duration, or those     with KS who discontinued treatment with another Kaposi's sarcoma therapy because of     inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's     sarcoma patients for whom DOX-SL therapy is indicated.   "
162474|NCT00002320|"     To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine     (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected     patients.      PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label     combination therapy.   "
162475|NCT00002321|"     To determine the MTD and dose-limiting toxicities of a regimen of therapeutic ganciclovir,     antiretroviral therapy, and recombinant interleukin-2 (aldesleukin; Proleukin) as an immune     adjuvant in HIV-seropositive patients. To investigate the effect of increasing doses of     Proleukin on the time to progression of CMV retinitis in patients being treated with     therapeutic ganciclovir and antiretroviral therapy. To evaluate the incidence and level of     anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient     population.   "
162476|NCT00002322|"     To determine the tolerance and antiviral response of two different doses of atevirdine     mesylate (U-87201E) in symptomatic HIV-positive patients with CD4 counts of 50-350 cells/mm3,     who also take zidovudine (AZT).   "
162477|NCT00002323|"     PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the     combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of     treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage.      SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in     patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two     regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two     regimens.   "
162478|NCT00002324|"     PRIMARY: To compare the effect of nevirapine versus placebo alone or in combination with     zidovudine (AZT) on CD4 T-cell count and percentage after 3 and 6 months of treatment. To     evaluate the safety and tolerance of nevirapine alone or in combination with AZT.      SECONDARY: To compare the effects of the various treatment combinations on virologic and     immunologic markers.   "
162479|NCT00002325|"     To compare the efficacy of fluconazole versus placebo in preventing the development of active     coccidioidomycosis and other systemic fungal infections among HIV-infected patients with CD4     lymphocyte counts < 250 cells/mm3 who are living in the coccidioidal endemic area.   "
162480|NCT00002326|"     To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of combination     zidovudine (AZT) and PMEA (adefovir) therapy.   "
162481|NCT00002327|"     To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for condyloma     acuminatum in patients with HIV infection. To investigate whether topical HPMPC therapy can     induce regression of condyloma acuminatum in patients with HIV infection.   "
162484|NCT00002330|"     To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three     doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for     26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study     doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.   "
162485|NCT00002331|"     PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus     ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium     Complex (dMAC).      SECONDARY: To determine the proportion of patients achieving a sterile blood culture along     with the time required to achieve it. To determine the duration of bacteriological response,     defined as length of time that blood cultures remain sterile.   "
162486|NCT00002332|"     To evaluate the mechanism whereby thymopentin appears to retard the progressive immune     suppression attributable to HIV infection.   "
162487|NCT00002333|"     To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone,     zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing     or unable to take zidovudine (AZT).   "
162488|NCT00002334|"     To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of     saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro     31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different     regimens.   "
162489|NCT00002335|"     To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in     HIV-infected patients. To determine the effects of food on bioavailability of 524W91.   "
162490|NCT00002336|"     To determine whether clarithromycin is safe and effective in preventing disseminated     Mycobacterium avium Complex in HIV-infected patients with CD4 counts <= 100 cells/mm3.   "
162492|NCT00002338|"     To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of     935U83 administered to patients with HIV infection. To obtain preliminary evidence of     antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug     resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.   "
162493|NCT00002339|"     To determine the safety, toleration, and efficacy of fluconazole oral suspension in the     treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.   "
162494|NCT00002340|"     To assess whether high dose or low dose atovaquone suspension is more effective than     aerosolized pentamidine as prophylaxis against Pneumocystis carinii pneumonia (PCP) in     high-risk HIV-infected patients. To compare the safety of chronic administration of the three     regimens in patients with advanced HIV disease. To determine the relationship between steady     state atovaquone plasma concentrations and prophylactic efficacy against PCP.   "
162495|NCT00002341|"     To provide maintenance treatment with itraconazole solution for patients who were clinical     responders in the ITR-USA-94 protocol, even if they subsequently relapsed.   "
162496|NCT00002342|"     To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152)     and to establish the MTD at each of the different dosing schedules.   "
162497|NCT00002343|"     To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum     rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to     examine the effect of combination therapy in preventing or delaying the incidence of MAC     bacteremia in this patient population.   "
162498|NCT00002344|"     To assess the dose proportionality of azithromycin concentrations and toleration when     delivered in tablet formulation to HIV-infected patients.      The need exists to further assess the antibacterial agent azithromycin at differing doses in     an HIV-infected population.   "
162499|NCT00002345|"     To further evaluate the safety of megestrol acetate (Megace) oral suspension in the treatment     of anorexia and cachexia in HIV-positive women. To compare the effectiveness of 2 doses of     Megace by measurement of weight gain, appetite grade, and other parameters at 12 and 24     weeks.   "
162500|NCT00002346|"     To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV     activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a     daily basis for 2 weeks to HIV-infected patients.   "
162501|NCT00002347|"     To evaluate the tolerance and immunologic and virologic effects of multidrug combinations of     antiretrovirals in patients with HIV infection. Specifically, to evaluate     zidovudine/zalcitabine ( AZT / ddC ) alone or in combination with either nevirapine or     saquinavir ( Ro 31-8959 ).      Administration of three-drug combinations for treatment of HIV infection is preferred over     monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug     combinations of antiretrovirals and allow the addition of new agents as they become     available.   "
162502|NCT00002348|"     To estimate the response rate, response duration, clinical benefit, and toxicity of     mitoguazone dihydrochloride (MGBG) in patients with AIDS-related refractory or relapsing     non-Hodgkin's lymphoma (NHL).   "
162503|NCT00002349|"     To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence     of recent HIV infection.      Also, to compare the immunologic effects and effects on quality of life of d4T in these     patients.   "
162504|NCT00002350|"     To evaluate safety and immune response in HIV-infected patients treated with multiple     injections of APL 400-003 vaccine.      PER 2/27/96 AMENDMENT: To evaluate the safety of the vaccine when administered via the     Biojector 2000 Needle-Free Injection Management System.      Facilitated DNA inoculation, a new type of DNA vaccine, involves direct injection of     non-infectious HIV genes into a patient's muscle, along with agents that promote uptake of     the genes into host cells. Host cells that have taken up these genes then produce viral     proteins in a form that elicits immune responses in the form of antibodies, killer T-cells,     and helper T-cells. The safety of this new vaccine approach needs to be assessed.      PER 2/27/96 AMENDMENT: The Biojector 2000 provides an option for delivering the vaccine     without a needle and employs a single-use syringe to avoid cross-contamination.   "
162505|NCT00002351|"     To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate     ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents. To compare the     plasma concentration profile after the initial dose with data from a historical group of     adults. To obtain preliminary data on antiviral activity of MK-639.   "
162509|NCT00002355|"     To determine a clinically safe and effective dose of intravitreally injected ISIS 2922 and to     compare the safety and efficacy of immediate versus delayed treatment in AIDS patients with     previously untreated, peripheral cytomegalovirus ( CMV ) retinitis.   "
162510|NCT00002356|"     To evaluate the efficacy and safety of ISIS 2922 in AIDS patients with Cytomegalovirus ( CMV     ) retinitis who are unresponsive or intolerant to ganciclovir and/or foscarnet but are     otherwise ineligible for ISIS Pharmaceuticals' controlled trials OR who have failed ISIS 2922     therapy on another controlled clinical trial.      PER 2/8/96 AMENDMENT: Patients must rollover from another ISIS 2922 controlled trial.   "
162511|NCT00002357|"     To obtain preliminary information on the safety, tolerability, and antiretroviral activity of     HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone.      PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated.   "
162512|NCT00002358|"     To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with     varicella-zoster viral disease who have failed or are intolerant of alternative therapy.   "
162513|NCT00002359|"     To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the     time prior to development of an AIDS-defining condition or death.   "
162514|NCT00002360|"     The purpose of this study is to see if the coated-capsule form of didanosine (ddI) is as safe     and absorbed by the body as well as the chewable-tablet form of ddI.      Didanosine (ddI) is an anti-HIV drug. The effectiveness of ddI can be lowered by acid in the     stomach. To prevent this, patients take antacids with ddI. The coated-capsule form of ddI may     replace the need for antacids.   "
162515|NCT00002361|"     The purpose of this study is to see if it is safe and effective to give an anti-HIV drug     combination containing indinavir and ritonavir to HIV-positive patients who have failed     previous treatment with protease inhibitors.   "
162516|NCT00002362|"     This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when     taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV     drugs.   "
162517|NCT00002363|"     To assess the effects of two doses of synthetic peptide construction 3 ( SPC3 ) on HIV-1     plasma levels (as measured by RNA PCR Amplicor) and on lymphocyte subsets in patients with     initial viral load above 10,000 copies/ml. To study the safety of SPC3 and the kinetics of     HIV-1 plasma level changes.   "
162518|NCT00002364|"     To obtain preliminary evidence of antiretroviral activity of 1592U89 when administered in     combination with other specific NRTI agents in NRTI experienced patients and to assess the     safety and tolerance of multiple oral doses of 1592U89 when administered in combination with     specific marketed NRTIs.   "
162519|NCT00002365|"     To determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected     patients.   "
162520|NCT00002366|"     To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir.   "
162521|NCT00002367|"     To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the     treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.   "
162522|NCT00002368|"     To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS     progression events or death when used in combination with Lamivudine and background     nucleoside therapy.   "
162523|NCT00002369|"     To evaluate the tolerance, and comparative virologic and immunologic effects of the two     combination regimens.   "
162524|NCT00002370|"     To demonstrate a dosage regimen for intravenous itraconazole that produces a plasma     concentration range comparable to that obtained after currently used oral dosages of     itraconazole oral solution; and to obtain preliminary safety data in patients with advanced     HIV disease.   "
162525|NCT00002371|"     To compare the magnitude and durability of the reduction in plasma HIV RNA in the two     treatment groups over the first 12 weeks of treatment. To determine the safety of each of the     two treatment groups.   "
162526|NCT00002372|"     To determine the steady-state pharmacokinetics of 141W94 in combination with saquinavir,     indinavir and nelfinavir after multiple oral dosing. To determine the steady-state     pharmacokinetics of saquinavir, indinavir, and nelfinavir in combination with 141W94 after     multiple oral dosing. To assess the safety and tolerability of multiple doses of 141W94 when     combined with saquinavir, indinavir and nelfinavir.   "
162527|NCT00002373|"     To evaluate the safety and tolerability of multiple escalating doses of 1263W94 administered     orally for 28 days in HIV infected patients with asymptomatic CMV shedding. To obtain     preliminary evidence of the in vivo anti CMV activity of different doses of 1263W94 in humans     based on quantitative reduction of CMV load in semen and if possible in other biological     fluids and to explore the dose response relationship in the anti-CMV activity of 1263W94.   "
162528|NCT00002374|"     To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other     antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel     capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study     treatment.   "
162529|NCT00002375|"     The purpose of this study is to see if it is safe and effective to treat HIV-infected     patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications.      It is thought that IDV plus NFV will be a safe drug combination for treating HIV.   "
162530|NCT00002376|"     To evaluate, in HIV-infected patients whose baseline CD4 count is 300 to 750 cells/mm3,     whether an antiretroviral treatment regimen based upon clinical evaluation and CD4 counts     plus HIV RNA viral load is more effective than a treatment regimen based upon clinical     evaluation and CD4 counts without the use of HIV RNA viral load information. To assess     relative utility of viral load testing in determining therapeutic choice by the surrogate     marker of CD4 cell counts after 48 weeks of therapy.      It is hypothesized that among HIV-infected patients whose baseline CD4 count is in the range     of 300 to 750 cells/mm3, those patients who incorporate initial and periodic viral RNA     measurements in their therapeutic decisions will have higher CD4 counts after 48 weeks than     patients whose therapeutic decisions do not incorporate initial and periodic viral RNA     measurements.   "
162841|NCT00002520|"     RATIONALE: Physician-initiated smoking cessation strategies may be effective in getting     early-stage cancer patients to quit smoking.      PURPOSE: Randomized clinical trial to compare the effectiveness of a physician-initiated     stop-smoking program with the usual care for patients receiving treatment for early-stage     cancer.   "
162531|NCT00002377|"     To investigate the efficacy and safety of RS-79070 when used as induction therapy in patients     with newly diagnosed peripheral retinitis. To assess the effects of induction and maintenance     level dosing of RS-79070 on CMV viral load, estimated by plasma CMV PCR. To assess the     pharmacokinetics of ganciclovir following administration of RS-79070 in the target     population.   "
162532|NCT00002378|"     To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of     detection (< 400 copies/ml) at week 24 of study therapy. To determine the absolute change in     plasma HIV-1 RNA during the 24 weeks of study treatment. To collect safety data on the     treatment regimens.      AS PER AMENDMENT 12/12/97: To compare the virologic response of Fortovase (FTV) (Saquinavir)     Soft Gel Capsule (SGC) tid plus nucleoside reverse transcriptase inhibitors (NRTIs) versus     FTV bid plus NRTIs. Further, to compare the virologic response of FTV tid plus NRTIs versus     FTV bid plus Nelfinavir bid plus a NRTI with respect to: the percentage of patients whose     plasma HIV-1 RNA level falls below the Amplicor assay level of detection (< 400 copies/ml) at     week 24 and week 48.   "
162784|NCT00002441|"     The purpose of this study is to see if an HIV vaccine, AIDSVAX B/B, can protect adults who     are at risk from becoming infected with HIV. Patients who become infected despite     immunization will be studied to see if receiving the vaccine before becoming infected will     help keep HIV levels (viral load) low.   "
165902|NCT00005718|"     To evaluate two educational programs that promoted the role of pediatric practices in     lowering LDL cholesterol levels in 4-10 year old hypercholesterolemic children through     dietary modification.   "
162533|NCT00002379|"     To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally     in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4     cell counts >= 100 cells/mm3 and an HIV-1 RNA baseline copy number >= 5000 copies/ml. To     determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of     detection (500 copies/ml) by 20 weeks of study therapy and the average reduction in HIV-1 RNA     from baseline through study week 20. To evaluate the durability of the antiviral response     through 48 weeks of study in patients who continue on study therapy after week 24.   "
162534|NCT00002380|"     To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of     saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in     combination with nelfinavir and nucleoside antiretroviral drugs (part 2), in HIV-infected     infants and children.   "
162535|NCT00002381|"     To determine the potential effects of 28 days of nevirapine treatment on the steady-state     pharmacokinetics of nelfinavir and of stavudine (d4T), and to further evaluate the     pharmacokinetics of nevirapine in combination with nelfinavir, and d4T compared to the     historical controls treated with nevirapine but without nelfinavir or d4T. To determine the     efficacy of long-term combination therapy of nevirapine, nelfinavir and d4T on viral load in     patients who are non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease     inhibitor naive, and have <= 6 months prior d4T exposure at the time of screening.   "
162536|NCT00002382|"     To offer an investigational agent (saquinavir) to people with HIV/AIDS who are in need of     additional treatment options and are not eligible to enroll in ongoing clinical trials.      Patients who no longer benefit from existing antiretroviral therapy and who are not currently     enrolled in ongoing saquinavir trials are eligible for this compassionate treatment program.   "
162537|NCT00002383|"     To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel     capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation     administered orally every 8 hours for 4 weeks.   "
162538|NCT00002384|"     Incomplete Closed Protocol   "
162539|NCT00002385|"     To identify doses of fozivudine tidoxil that are well tolerated and produce measurable     antiviral activity.      To identify the adverse event profile that defines the maximum tolerated dose. To     characterize the single- and multiple-dose pharmacokinetics of fozivudine and its     metabolites.      To correlate the adverse event profile and antiviral activity of fozivudine with     pharmacokinetic parameters.   "
162540|NCT00002386|"     The purpose of this study is to see if indinavir plus two other anti-HIV drugs affect blood     clotting in HIV-positive patients with hemophilia.   "
162541|NCT00002387|"     To estimate the differences in parameters of antiviral activity and safety between a control     regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose     indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing, in protease     inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive, HIV-1 seropositive     patients.      It is hypothesized that after 16 weeks of randomized treatment with either the control or     experimental regimen that:        1. The observed proportion of patients with serum viral RNA < 400 copies/ml in the          experimental and control regimen will be similar and will continue to be so after 48          weeks.        2. The safety profiles of the two groups will be similar, judged by the incidence of          serious, drug-related adverse experiences and the incidence of events of specific          interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and          CNS-related symptoms) and will continue to be so after 48 weeks.        3. The two groups will be similar with respect to changes from baseline in serum viral RNA          and CD4 counts and will continue to be so after 48 weeks.   "
162542|NCT00002388|"     The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients.     This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the     blood).   "
162543|NCT00002389|"     To compare the durability of the viral load response following 48 weeks of treatment with     1592U89/lamivudine (3TC)/zidovudine (ZDV) versus 3TC/ZDV alone. To compare the early     antiviral activity following 16 weeks treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone as     demonstrated by the proportion of subjects with viral load < 400 copies/ml, plasma HIV-1 RNA     profiles and CD4+ profiles. To assess the safety and tolerance following 16 and 48 weeks of     treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone.   "
162544|NCT00002390|"     The purpose of this study is to see if giving 1592U89 to HIV-infected patients is safe and     effective in lowering viral load (level of HIV in the blood) and raising the level of CD4     cells (cells of the body that help fight infection).   "
163698|NCT00003871|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of PSA     vaccines in treating patients who have advanced prostate cancer.   "
162545|NCT00002391|"     To compare the safety, tolerance, durability of the viral load response and the antiviral     activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen. To     determine the clinical efficacy of the two regimens as measured survival, disease     progression, weight growth velocity, and neuropsychological or neurological changes. To     assess the development of viral resistance and relative pharmacokinetics associated with each     regimen.   "
162546|NCT00002392|"     To ascertain the effect of thalidomide on immune responses to vaccination with polyvalent     pneumococcal polysaccharide vaccine and tetanus toxoid in HIV-infected patients;     particularly, on markers of immune activation and parameters of specific, anti-HIV cellular     immunity.   "
162547|NCT00002393|"     The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV     treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).   "
162548|NCT00002394|"     The purpose of this study is to see if it is safe and effective to give Lamisil to     HIV-positive patients with thrush (a fungal infection) that has not responded to fluconazole.   "
162549|NCT00002395|"     The purpose of this study is to see if it is safe and effective to give topotecan through a     vein to treat HIV-infected patients with PML, an opportunistic (AIDS-related) infection     caused by a virus that infects brain tissue and causes damage to the brain and the spinal     cord.      Topotecan fights HIV and the JC virus (the virus that causes PML) in laboratory experiments.   "
162785|NCT00002451|"     The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV)     in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have     never received anti-HIV therapy. This study will look at the effectiveness of this drug     combination and side effects.   "
162550|NCT00002396|"     To evaluate the safety of single and multiple doses (28 daily doses) of     9-[2-(R)-[[bis[[(isopropoxycarbonyl)- oxy]methoxy]phosphinoyl]methoxy]propyl]adenine fumarate     (PMPA) prodrug administered orally to HIV-infected patients. To determine the     pharmacokinetics of single and multiple doses of PMPA prodrug when administered orally to     HIV-infected patients. To evaluate the anti-HIV activity of PMPA prodrug, as demonstrated by     increases in CD4 cell counts and decreases in HIV RNA, when administered orally as a single     dose and daily for 4 weeks to HIV-infected patients with CD4 cell counts of 200 or more     cells/mm3.   "
162551|NCT00002397|"     The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus     stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir plus d4T in     patients with HIV-associated kidney disease. This study examines whether these drug     combinations are effective in preventing kidney disease from progressing to a stage where it     is immediately life threatening. This study also examines the effect these drug combinations     have on the level of HIV detected in these patients. Finally, this study evaluates the drug     level (the amount of drug found in the body) of these two combinations in patients with     kidney disease.   "
162552|NCT00002398|"     The purpose of this study is to see if it is safe and effective to give adefovir plus other     anti-HIV drugs to HIV-infected patients who have failed other anti-HIV drug combinations.     This study will try to make adefovir available to all AIDS patients who need it.      Some patients do not respond to anti-HIV drug combinations, even when different combinations     are tried. Adefovir may be able to help these patients fight HIV.   "
162553|NCT00002399|"     The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that     of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive     patients.   "
162554|NCT00002400|"     The purpose of this study is to compare the safety and effectiveness of giving HIV-infected     patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus     IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is     given in combination with other drugs.   "
162555|NCT00002401|"     The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in     combination with two or three other drugs to HIV-infected patients. The drugs to be used in     combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).   "
162556|NCT00002402|"     The purpose of this study is to see if it is safe and effective to give AIDSVAX B/B or     AIDSVAX B/E, two potential HIV vaccines, to HIV-negative volunteers.   "
162557|NCT00002403|"     The purpose of this study is to see if it is safe and effective to give zintevir (AR177) to     asymptomatic (no symptoms) HIV-infected patients.      Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. HIV uses the     protein integrase to infect a cell. Integrase inhibitors block integrase and may stop     replication of HIV.   "
162558|NCT00002404|"     The purpose of this study is to see if valacyclovir affects the detection of HIV in genital     herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital     herpes.   "
162559|NCT00002405|"     The purpose of this study is to see if it is safe to give amprenavir (APV) to HIV-infected     patients. This study also examines the effect APV has on the level of HIV in the blood.      Earlier studies have shown that APV is effective in slowing the growth of HIV in the body.     Patients who have failed previous anti-HIV treatment or who are unable to take other protease     inhibitors (PIs) may benefit from the availability of a new PI such as APV.   "
162560|NCT00002406|"     The purpose of this study is to determine if two dose levels of indinavir combined with two     nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma     viral load (level of HIV in the blood).   "
162561|NCT00002407|"     The purpose of this study is to see if it is safe and effective to give one of three     different triple-drug combinations to HIV-infected patients who have never been treated with     anti-HIV drugs.   "
162562|NCT00002408|"     To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool     weight in AIDS patients with diarrhea over 6 days of treatment.   "
162563|NCT00002409|"     The purpose of this study is to see if an HIV-education course can help under-represented,     HIV-infected patients. This study examines the areas of faithfulness to drug regimen, level     of HIV in the blood, and health status.   "
163268|NCT00002947|"     RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells.     Giving radiation therapy in different ways may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of indium In 111 pentetreotide in treating     patients who have refractory cancer.   "
162564|NCT00002410|"     The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug     combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266     plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study     also examines the resistance HIV may have to these drugs and if these drugs are effective     over a long period of time.   "
162565|NCT00002411|"     The purpose of this study is to compare the safety of didanosine plus stavudine plus     nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines     how long these drug combinations are effective in lowering viral load (level of HIV in the     blood).   "
162566|NCT00002412|"     The purpose of this study is to see if it is safe and effective to give MKC-442 plus     stavudine (d4T) plus didanosine (ddI) plus hydroxyurea.   "
162567|NCT00002413|"     The purpose of this study is to see if it is safe and effective to give MKC-442 plus at least     two other anti-HIV drugs to patients who have never been treated with nonnucleoside reverse     transcriptase inhibitors but who have been treated with nucleoside reverse transcriptase     inhibitors and protease inhibitors. This study also determines how long a drug combination     including MKC-442 is effective.   "
162568|NCT00002414|"     The purpose of this study is to see if it is safe and effective to give CPI-1189 to patients     with AIDS dementia.      Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of     memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.   "
162786|NCT00002452|"     The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with     indinavir and if it works well at lowering the level of HIV in the blood (viral load).   "
162787|NCT00002453|"     This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil     fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the     drug causes.   "
162569|NCT00001757|"     Invasive fungal infections are often life-threatening in persons with immunocompromise.     Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at high risk for     these infections. Patients undergoing bone marrow transplantation, receiving prolonged     corticosteroid or other immunosuppressive therapies, and persons with HIV infection and AIDS     are also at risk. With the use of currently approved antifungal therapy, many of these     infections may still be associated with a high mortality. Amphotericin B in its conventional     form, is the current standard treatment for most life-threatening fungal infections. Because     of its nephrotoxicity and other adverse effects, alternatives to conventional amphotericin B     have been sought. Alternated agents include three lipid formulations of amphotericin B,     fluconazole, itraconazole. Although all of these agents are associated with a decrease in     adverse effects, their efficacy in most life-threatening fungal infections has not been shown     to be equivalent to conventional amphotericin B.      Voriconazole is an investigational antifungal drug currently being brought to phase III     trials in the US. This azole has been shown active against many fungal pathogens in vitro. In     animal models and early human trials this new agent has been shown to be effective against     aspergillosis. It has been shown to be well-tolerated and is available in an intravenous and     oral formulation.      This is a non-comparative, open label study to evaluate the efficacy, safety and toleration     of voriconazole in the treatment of invasive fungal infections. This agent will be used as     primary therapy in those fungal infections in which no antifungal agent is currently approved     or in patients unable to tolerate the approved agent. Voriconazole will also be used as a     secondary treatment in those patients who have failed therapy with the primary approved agent     or are unable to tolerate that agent or have unacceptable toxicity.   "
162570|NCT00001758|"     This study will continue to treat and collect safety and efficacy data on patients who     participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir,     amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of     Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects     with Detectable [greater than 400 Copies/mL] HIV-1 Plasma RNA Despite Treatment with a     Protease Inhibitor-Containing Regimen).      HIV-infected patients 18 years of age and older who participated in the above study at the     NIH site may be eligible for the current study. Participants will be followed every 3 months     with a general health evaluation and laboratory tests. This is a NIH study, and information     will not be provided to Glaxo Wellcome   "
162571|NCT00001759|"     Asthma is a chronic inflammatory disease. We propose to study inflammatory changes in the     lungs of subjects with atopic asthma of different severity in vivo using positron emission     tomography (PET) with 2-deoxy-2-[18F]fluoro-D-glucose (FDG). It has been shown that the     uptake of FDG as detected by PET scanning correlates with inflammation in animal models as     well as in human disease processes such as sarcoidosis, tuberculosis and abscess formation.     In addition, it has been shown that the inflammation associated with allergen challenge in     patients with atopic asthma can be visualized using PET scanning with FDG. We hypothesize     that the degree of FDG-uptake as a measure of inflammation correlates with the severity of     asthma as determined by pulmonary function tests and clinical signs and symptoms. In     addition, information about the spatial distribution of the inflammatory changes will be     obtained. To compare the characteristics of the inflammation in asthma with non-asthmatic     inflammation of the lung, the images obtained in asthmatic subjects will be compared with     images from subjects who have inflammatory changes of the lung caused by Wegener's     granulomatosis. Subjects with atopic asthma and non-atopic control subjects will be selected     from the community and, if eligible for the study, undergo skin testing against common     allergens and pulmonary function testing. Subjects with Wegener's granulomatosis will be     selected from a large group of subjects followed with this disease at NIAID. PET scanning     with FDG will be used to measure inflammation in the PET scanning facility at the Clinical     Center of the NIH and the results of the scanning will be correlated with the severity of the     disease. We expect that for the first time this methodology will permit an objective measure     of the basic pathogenic process, the allergic inflammation, in patients with atopic asthma.     Using this methodology it will be possible to study the efficacy of currently available     therapies for allergic inflammation. In addition, this methodology will provide an extremely     useful tool for the development of new therapeutic approaches to the treatment of asthma.   "
162572|NCT00001760|"     Cytokine Production Patterns in Patients with Systemic Mastocytosis Compared with Atopic     Dermatitis and Healthy Individuals      Summary: This study will examine how mast cells (cells involved in allergic reactions)     migrate and multiply in the skin of patients with mastocytosis, a condition characterized by     too many mast cells in the body. The mast cells tend to multiply in the skin, causing dark,     itchy skin spots known as urticaria pigmentosa. This study will determine if the skin of     patients with mastocytosis produces chemicals called cytokines that cause mast cells to     migrate to the skin and multiply. The findings will be compared with those from normal     volunteers and patients with atopic dermatitis, a skin disease characterized by recurrent     itchy rash usually seen in people with a family history of allergies.      Healthy volunteers, patients with mastocytosis and patients with atopic dermatitis 18 years     of age and older may be eligible for this study. Participants will have the following tests     and procedures:        -  Suction blisters - Two to eight small blisters will be raised on the forearm using          gentle suction. The fluid in the blisters will be collected with a syringe to study the          chemicals produced by the skin. The tops of the blisters may be removed for research.        -  Template study - Patients with high cytokine content in the blister fluid may have a          template study. For this procedure, a plastic block (template) with holes matching the          blister sites is placed over the blistered area. The wells of the template are filled          with salt water and the fluid is removed with a syringe at 3, 8 and/or 24 hours.          Patients are hospitalized for 24 hours for this study.        -  Skin biopsy - A skin biopsy will be done to correlate cytokine levels with the number of          mast cells in the skin. An area of skin is numbed with an anesthetic and a small          circular area about the size of a pencil eraser is removed, using a sharp cookie          cutter-type instrument.        -  Blood draw - About 4 tablespoons of blood will be drawn to compare the chemicals in the          blood with those in the blister fluid. The blood will also be analyzed for a complete          blood count, clotting factors and substances that may be elevated in people with          allergies.   "
162733|NCT00001981|"     The purpose of this study is to investigate the treatment and natural history of acromegaly.     We have a longstanding interest in acromegaly treatment, and a cohort that has been followed     for 30 years, or more in some cases. We will continue to follow patients and recruit new     patients for treatment and follow-up. Blood and pituitary tumor tissue (when available     through clinical care) will be saved for future analyses related to acromegaly.   "
162573|NCT00001761|"     The purpose of this study is to assess the safety, tolerance, and immunologic effects of     interleukin-10 (IL-10), in patients with Wegener's granulomatosis. A secondary objective is     to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of     Wegener's granulomatosis to warrant further study in a larger trial. In this study, IL-10     will be given either alone or in combination with standard therapeutic agents, usually     consisting of cyclophosphamide, methotrexate, and/or prednisone. Patients will be eligible to     receive IL-10 when there is evidence of active disease. IL-10 will be administered by     subcutaneous injection at a dose of 4 µ (Micro)g/kg/day for 28 days.   "
162574|NCT00001762|"     This study will examine risk factors for facial wasting and avascular necrosis (AVN, a type     of damage to the hip and other bones) in HIV-infected patients. The prevalence and natural     history of AVN are also being evaluated. This study will use magnetic resonance imaging (MRI)     to identify and monitor these conditions in patients with and without diagnosed AVN and to     identify risk factors.      HIV-infected patients 18 years of age and older may be eligible for this study. HIV-infected     children 4 years and older who can tolerate magnetic resonance imaging without sedation may     also participate. Candidates may be screened for participation with a medical history,     physical examination, blood and urine tests and possibly an electrocardiogram. Volunteers     will provide a medical history and may have a brief physical examination. The study is     currently closed to normal volunteers.      HIV-infected patients will have a MRI scan of the hip bone, and possibly other bones. Before     the scan, they will provide a medical history by interview or questionnaire and have a     physical examination. Those with diagnosed AVN will also have blood drawn to help identify     potential risk factors for AVN. For the MRI, the patient lies flat on a stretcher that is     moved into a cylindrical machine with a strong magnetic field. Earplugs are worn to muffle     thumping sounds produced by radio waves that form the images. Patients can speak with a staff     member via an intercom system at all times during the procedure. Repeat MRI studies will be     requested at approximately 3- to 12-month intervals for up to 5 years, to see if changes     occur with time. If medically indicated, additional diagnostic studies may be done to obtain     information needed for appropriate medical care. Blood will be drawn periodically to examine     immune parameters and viral blood levels. Patients with AVN may have periodic consultations     with the rehabilitation medicine service and orthopedic surgeons.   "
162758|NCT00002007|"     To evaluate the safety of repeated courses of sargramostim ( recombinant     granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to     patients with HIV infection and leukopenia. To determine if administration of GM-CSF will     prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment     in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits     from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV     infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP     ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.   "
162575|NCT00001763|"     Disseminated infection with Mycobacteria avium complex (MAC) is one of the most common     systemic bacterial infections in advanced stages of the acquired immunodeficiency syndrome     (AIDS). Current therapy for disseminated MAC infection in HIV patients consists of multidrug     chemotherapy regimens are often accompanied by toxicities, and many patients become     intolerant of one or more agents. Macrolides are the essential component of successful     therapy, yet macrolide resistant strains are being recognized with increasing frequency.     Thus, there is an interest in identifying additional therapeutic interventions for     disseminated MAC in HIV-infected patients. Interleukin-12 (IL-12) is a central, regulatory     cytokine in cell-mediated immunity. IL-12 enhances the cytolytic activity of cytotoxic T and     NK cells, and induces interferon-gamma (IFN gamma) production from T and NK cells. This     open-label Phase I study is designed to evaluate the safety and immunologic/microbiologic     effects of interleukin-12 administration in HIV-infected patients with concomitant     disseminated Mycobacterium avium (MAC) infection. Fifteen patients with documented     disseminated MAC will be randomized to receive double-blinded placebo or escalating doses of     IL-12 in addition to anti-MAC chemotherapy and standard anti-retroviral therapy for six     weeks. IL-12 will be administered subcutaneously, with escalating doses every month over the     dose range of 30 ng/kg, 100 ng/kg, and 300 ng/kg, or until an individual maximum tolerated     dose (IMTD) is reached. Should a patient receive 2 consecutive blood cultures negative for     MAC during the course of the study at a lower dose, then he/she will not be further dose     escalated. Those patients receiving placebo after 6 weeks will be crossed over to receive the     full treatment course of IL-12. Each new dose or dose escalation will take place on an     inpatient basis. Once a patient is clinically stable at a dose, the patient will be     maintained at that dose as an outpatient for the remainder of the month. Total IL-12     administration will not exceed 12 weeks, or 24 total doses.   "
162576|NCT00001764|"     This study will examine the safety and effectiveness of the drug mycophenolate mofetil (MPM)     in treating Wegener's granulomatosis and related inflammatory vessel diseases. Blood vessel     inflammation in these patients may involve different parts of the body, including the brain,     nerves, eyes, sinuses, lungs, kidneys, intestinal tract, skin, joints, heart, and other     sites. The more severe the involvement, the more likely the disease will be life-threatening.     Standard treatment consists of combination drug therapy with prednisone and a cytotoxic     agent-usually cyclophosphamide or methotrexate. However, some patients in whom this treatment     is initially successful have a disease relapse; other patients cannot take the medications     because of other health problems or because of severe side effects of the drugs.      MPM is approved by the Food and Drug Administration to prevent kidney transplant rejection.     It is chemically similar to another cytotoxic drug called azathioprine, which has been     beneficial in maintaining remission in patients with Wegener's granulomatosis who have been     treated successfully with cyclophosphamide. Because MPM is more effective than azathioprine     in preventing organ rejection, it may also prove beneficial as a second-line treatment for     Wegener's granulomatosis.      Patients with Wegener's granulomatosis or related inflammatory vessel diseases who have had a     relapse following treatment with cyclophosphamide and methotrexate or who cannot take one or     both of these drugs may be eligible for this study. Only patients who have been treated at     NIH in the methotrexate protocol or the cyclophosphamide switching to methotrexate protocol,     or who have received the exact same treatment from their own physician may participate.      Participants will have a complete medical evaluation including laboratory studies.     Consultations, X-rays and biopsies of affected organs may also be done if indicated for     diagnosis or treatment. Patients with active disease will be given MPM and prednisone, both     in tablet form. Patients with inactive disease will receive only prednisone if they are     already taking it. In both cases, the prednisone will be reduced gradually and discontinued     if the disease improves significantly. MPM therapy will continue for at least 2 years. If     after 2 years the disease remains in remission, the MPM dose will be gradually reduced and     then stopped. If active disease recurs while on MPM therapy, the treatment plan will likely     be changed. The new regimen will be determined by the severity of disease, other medical     conditions, and history of side effects to previous medications.      Patients will be followed at the NIH clinic every month for the first 3 months on MPM and     then every 3 months for another 18 months. Those whose disease has remained in remission and     have stopped all medications will then be followed every 6 months for 4 visits. The follow-up     visits will include a physical examination, blood draws, and, if needed, X-rays. Visits may     be scheduled more frequently if medically indicated.   "
162577|NCT00001765|"     This study will investigate the safety and effectiveness of a modified stem cell transplant     procedure for treating chronic granulomatous disease (CGD) in patients with active infection.     CGD is an inherited disorder of neutrophils-a type of infection-fighting white blood     cell-that leaves patients vulnerable to life-threatening infections. Transplantation of     donated stem cells (cells produced by the bone marrow that mature into the different blood     components-white cells, red cells and platelets) can cure CGD. However, this procedure     carries a significant risk of death, particularly in patients with active infection, because     it requires completely suppressing the immune system with high-dose chemotherapy and     radiation. In addition, lymphocytes-another type of infection-fighting white blood cell-from     the donor may cause what is called graft vs. host disease (GvHD), in which the donor cells     recognize the patient's cells as foreign and mount an immune response to destroy them. To try     to reduce these risks, patients in this study will be given low-dose chemotherapy and no     radiation, a regimen that is easier for the body to tolerate and involves a shorter period of     complete immune suppression. Also, the donor's lymphocytes will be removed from the rest of     the stem cells to be transplanted, reducing the risk of GvHD.      Patients with CGD between the ages of age 1 and 55 years old who do not have an active     infection and who have a family member that is a well matched donor may be eligible for this     study. Candidates will have a medical history, physical examination and blood tests, lung and     heart function tests, X-rays of the chest and sinuses, and dental and eye examinations. A     bone marrow sample may be taken to evaluate disease status. This test, done under a local     anesthetic, uses a special needle to draw bone marrow from the hipbone.      Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF     will be injected under the skin for several days to increase stem cell production. Then, the     stem cells will be collected by apheresis. In this procedure the blood is drawn through a     needle placed in one arm, pumped into a machine where the desired cells are separated out and     removed, and then the rest of the blood is returned through a needle in the other arm.      A large plastic tube (central venous line) is placed into a major vein. It can stay in the     body and be used the entire treatment period to deliver the donated stem cells, give     chemotherapy or other medications, including antibiotics and blood transfusions, if needed,     and withdraw blood samples. Several days before the transplant procedure, patients will start     low-dose chemotherapy with cyclophosphamide and fludarabine, two commonly used anti-cancer     drugs. They will also be given anti-thymocyte globulin to prevent rejection of the donated     cells. When this conditioning therapy is completed, the stem cells will be infused through     the central line. Patients will be given cyclosporine by mouth or by vein from 4 days before     until 3 months after the stem cell transplant to help prevent rejection.      The average hospital stay for stem cell transplant is 30 days. After discharge, patients will     return for follow-up clinic visits weekly or twice weekly for 4 months. These visits will     include a symptom check, physical examination, and blood tests. Blood transfusions will be     given if needed. Subsequent visits will be scheduled at 4, 6, 12, 18, 24, 30 and 36 months     after the transplant or more often if required, and then yearly.   "
162578|NCT00001766|"     This study examined the interactions of various drugs used to treat HIV infection in order to     design larger studies of possible combinations for people who continue to have high viral     levels despite combination therapy.      HIV-infected patients 18 years of age and older who have a viral load of at least 500     copies/mL; who have received 20 weeks of protease inhibitor therapy, with the same protease     inhibitors in combination therapy for the last 12 weeks; and who have never been treated with     abacavir, amprenavir or efavirenz were enrolled.      All patients will receive 600 milligrams a day of efavirenz (a non-nucleoside reverse     transcriptase inhibitor); 300 mg twice daily of abacavir (a nucleoside analog); and 1200 mg     twice a day of amprenavir (a protease inhibitor). In addition to these drugs, six patients     will receive 500 mg twice a day of ritonavir (a protease inhibitor); six patients will     receive 200 mg twice a day of ritonavir; and 10 will receive 1250 mg twice a day of     nelfinavir (a protease inhibitor).      Patients in the two ritonavir groups (500-mg and 200-mg dose groups) took abacavir and     amprenavir for one week and then come to the clinic for blood tests to measure drug levels     before taking their morning pills and at 1/2, 1, 2, 4, 8, and 12 hours after taking the     medicines. They will then add ritonavir to their treatment regimen. After one week, they will     return for blood tests as before. They will then add efavirenz to their regimen and had     bloods drawn again after another 1 or 2 weeks.      Patients in the nelfinavir group took abacavir, amprenavir and nelfinavir for one week and     then have blood sampling as described above for the ritonavir group. They will then add     efavirenz to the regimen and repeat the blood tests again after another 1 or 2 weeks.      Participants are being seen in the clinic for follow-up only if they wish to continue to     participate and if the regimen appears to offer clinical benefit.   "
162857|NCT00002537|"     Phase I trial to study the effectiveness of radiation therapy plus topotecan in treating     patients who have non-small cell lung cancer. Drugs used in chemotherapy use different ways     to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and     radiation therapy may kill more tumor cells.   "
162579|NCT00001768|"     Recent research studies of early onset-obsessive compulsive disorder (OCD) and Tourette's     syndrome have questioned whether autoimmunity could play a role in the development of these     conditions. As a result, there has been an increased interest in the field of research on the     potential involvement of autoimmunity in other psychiatric conditions like schizophrenia.      Autoimmune conditions occur when the normal immune system of the body begins working against     itself. The immune system recognizes cells as foreign and begins to attack them.      There are several similarities between autoimmune diseases and schizophrenia. Genetics play     some role in the development of both diseases. Both conditions show a similar course, and     both conditions tend to show worsening of symptoms when exposed to stress.      Previous research studies have shown intravenous immunoglobulin to be safe and effective when     used in neurologic diseases involving the immune system. Presently the NIMH is testing the     effectiveness of IVIg in OCD and Tourette's syndrome.      Intravenous Immunoglobulin IVIg is a medication that has been used to treat diseases like     Kawasaki disease, systemic juvenile rheumatoid arthritis, lupus nephritis, and idiopathic     thrombocytopenic purpura. The drug modifies the body's natural immune reactions.      This research study is a 13-week trial of intravenous immunoglobulin (IVIg) on patients     suffering from childhood-onset schizophrenia, who have failed to respond to other therapies.   "
162580|NCT00001770|"     Often women are prescribed hormone replacement therapy (HRT) during the perimenopause or     menopause.      Hormone replacement therapy includes both estrogen and progesterone. The estrogen component     of HRT helps to relieve the symptoms and has a beneficial effect on the heart and bones, but     estrogen also increases the risk of uterine cancer. The progesterone component of the HRT     (progestin) works to prevent the increased risk of uterine cancer.      There is evidence that some women experience unpleasant mood symptoms (such as irritability,     depressed mood and anxiety) while receiving hormone replacement therapy (HRT) while taking     the progestin / progesterone component of the HRT.      This study is designed to evaluate the ability of progestins to produce negative mood     symptoms in women. Researchers intend on doing this by comparing the effects of     medroxyprogesterone acetate (Provera) and a placebo inactive sugar pill. Patient's moods will     be monitered based on their response to questionnaires answered in the outpatient clinic and     at home.      This research will attempt to answer the following questions:        1. Are progestins associated with changes in mood during hormone replacement therapy?        2. If progestins are associated with mood disturbance, is it because they are blocking the          beneficial effects of estrogen?   "
165903|NCT00005719|"     To conduct a five-year demonstration and education project to sustain smoking cessation     postpartum by women who had stopped smoking in pregnancy.   "
162581|NCT00001771|"     Abnormalities in the re-uptake of dopamine and serotonin have been described in various     neuropsychiatric disorders and substance abuse. [I-123] Beta-CIT is a recently developed     radioligand for SPECT imaging of dopamine and serotonin transporters. [I-123]Beta-CIT SPECT     has been used at the SPECT-lab of the Clinical Brain Disorders Branch in over fifty subjects     without adverse events. Due to the trace concentrations used, a pharmacological effect of     Beta-CIT is unlikely and has not been observed. The purpose of this study is to use Beta-CIT     and SPECT to study the expression of dopamine and serotonin transporters in vivo in normal     controls and various patient populations to address hypothesized abnormalities of the     transporters in different disorders and to understand the effects of genetic variations in     the genes of these transporters on their in vivo expression.   "
162582|NCT00001772|"     Bipolar disorder is a mood (affective) disorder characterized by the occurrence of     alternating feelings of excitement (mania) and depression. It is a common, but serious     condition, and potentially life-threatening. Patients are considered to have a rapid cycling     form of bipolar disorder if they experience four or more episodes of hypomania (mild degree     of mania), mania, and/or depression. Approximately 20% of the patients in bipolar clinics     have the rapid cycling form of the disorder. Therefore it can be said that RCBD is not a rare     condition and that it can severely impair a patient. These reasons alone justify studying     RCBD. However, researchers also believe that information gathered by studying patients with     RCBD can be used while studying other patients with different forms of bipolar disorder.      The purpose of this study is to screen patients diagnosed as having rapid cycling bipolar     disorder to see if they fit the criteria for the diagnosis and to see if they would be     interested in participating in other research studies.      Patients will undergo diagnostic interviews, physical examination, routine blood tests, EKG     (electrocardiogram), and complete self-rating forms as part of the screening process.   "
162583|NCT00001774|"     Fabry's disease a genetic disorder (X-linked recessive) due to the absence of the enzyme     alpha-galactosidase A. The disease is characterized by abnormal collections of glycolipids in     cells (histiocytes) within blood vessel walls, tumors on the thighs, buttocks, and genitalia,     decreased sweating, tingling sensations in the extremities, and cataracts. Patients with     Fabry 's disease die from complications of the kidney, heart, or brain.      The objective of this study is to test the belief that patients with Fabry's disease have a     problem with blood vessels becoming larger. The walls of blood vessels contain muscles that     when they relax the vessel becomes larger. This process is referred to as vasodilation. It is     controlled by a substance released by cells in blood vessels called EDRF (endothelium-derived     relaxing factor).      Several drugs can affect vasodilation. Researchers believe some drugs may work by blocking     the affect of EDRF. Researchers would like to test the effects of these drugs on the blood     vessels of normal volunteers and patients with Fabry's disease.   "
162617|NCT00001841|"     Magnetic Resonance Angiography (MRA) is a method used to evaluate arteries and veins without     the use of invasive catheters or x-rays (radiation). MRA technique has been continuously     improving and has become more accurate at diagnosing problems of narrowing in blood vessels.     However, MRA has a difficult time detecting narrowing in small blood vessels, limiting its     use to large arteries.      The purpose of this study is to recruit patients diagnosed with or suspected of having,     atherosclerosis (hardening of the arteries) to participate in a series of new     state-of-the-art diagnostic tests using MRA.      This study is a combined effort between the National Institutes of Health (NIH), Uniformed     Services University of the Health Sciences (USUHS), and General Electric Medical Services and     is supported a Cooperative Research Agreement is to (CRADA).      The goal of this study is to improve MRA to the point that it can reliably replace diagnostic     x-ray catheter angiography in the evaluation of patients with atherosclerosis.   "
162584|NCT00001776|"     Imaging studies of the brain have revealed the different areas involved in the processes of     learning and reasoning. However, the specific role these regions play in these processes, or     if stimulating these areas can improve these processes is unknown.      Researchers would like to use repetitive transcranial stimulation (rTMS) to better understand     the roles of individual brain regions on the processes of learning and reasoning. Repetitive     transcranial magnetic stimulation (rTMS) involves the placement of a cooled electromagnet     with a figure-eight coil on the patient's scalp, and rapidly turning on and off the magnetic     flux. This permits non-invasive, relatively localized stimulation of the surface of the brain     (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location,     intensity and frequency of the magnetic pulses.      The purpose of this study is to use rTMS to help determine the roles of different brain     regions in the development of implicit learning of motor sequences and analogic reasoning. In     addition, researchers hope to evaluate if stimulation of these regions speeds up the process     of learning or analogic reasoning.   "
162585|NCT00001777|"     Dementia refers to a condition where there is a loss of intellectual function (cognition). It     is usually a progressive condition that interferes with normal social and occupational     activities.      Patients with frontal lobe dementia (FLD) suffer from a destruction of the brain cells found     in the frontal lobe of the brain. Loss of frontal lobe neurons can cause changes in     personality, such as aggressiveness, agitation, and depression. In addition, patients with     FLD may have difficulty planning tasks and may have a loss of motivation.      Researchers believe that the cells lost in the frontal lobe of the brain are responsible for     producing a chemical called serotonin. Serotonin is a neurotransmitter, which means it is     used by neurons to communicate with other neurons. Researchers are inclined to believe that     by replacing the missing serotonin, symptoms of FLD may be relieved.      Drugs known as serotonin uptake inhibitors, help to maintain high levels of serotonin in the     body. They have been used successfully to treat patients with depression and patients with     violent / impulsive behaviors. Sertraline is a serotonin reuptake blocker that is relatively     easy to give (once daily), is safer than most other serotonin reuptake blockers (very little     effect on vital enzyme systems [cytochrome P-450]), and has few interactions with other     drugs.      This study is designed to test the effectiveness of Sertraline for the treatment of symptoms     associated with FLD. Patients participating in the study will receive Sertraline for 6 weeks     and a placebo inactive sugar pill for 6 weeks. During the study, researchers will test     psychological and neurological functions to measure the effects of the drug.   "
162604|NCT00001814|"     Investigation of the causes of genetic defects relating to hereditary urologic malignancies     will be undertaken. These rare disorders result from inherited or newly arising mutations in     genes involved in the development and function of different organ systems. As specific     disease syndromes are recognized and the responsible genes identified, mutations in     individual families can be identified. Correlation of mutation sites with clinical     information will help determine how specific gene segments encode important functional     protein domains.      Families with urologic malignant disorders of known or suspected genetic basis will be     enrolled. Genetic linkage studies will include all available family members, while gene     sequence analysis will be performed on affected individuals. Unaffected family members or     unrelated normal individuals will serve as controls. The family members will be identified by     the proband or proband's parent when the initial pedigree is taken. Subjects considered by     the investigators to be appropriate for linkage studies will be invited to participate by the     local genetics provider or by the investigators, who will then connect these members to their     own local providers for enrollment.      In our studies of inherited urologic malignant disorders, there may be individuals from renal     cancer families who do not undergo clinical evaluation for the presence of an inherited     urologic malignant disorder at the National Institutes of Health because of their health     problems, geographical location, or personal preference. Even though these individuals do not     undergo a clinical evaluation of their suspected inherited urologic malignant disorder at the     National Institutes of Health, they may have rare diseases that are extremely important to     study. Therefore, we intend to collect blood samples for genetic studies from these     individuals to facilitate linkage analysis and disease gene identification. Samples will be     collected either by the individual's physician and sent to NIH, or will be collected by NIH     physicians at either the individual's off-site location or at the NIH.   "
162586|NCT00001778|"     Objective:      Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis     (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with     the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP by     monitoring clinical progression of patients longitudinally. Additionally, we will attempt to     define the virological and immunological changes of HAM/TSP.      Study Population:      Patients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible     to participate in this protocol. Asymptomatic seropositive individuals and individuals with     indeterminate HTLV-1 serology are also eligible to participate.      Design and Outcome Measures:      A longitudinal assessment of clinical, virological and immunological progression in HAM/TSP     will be accomplished through periodic testing and evaluation. Asymptomatic seropositive     individuals, those with seroindeterminate HTLV-I serology and normal volunteers may serve as     controls. Longitudinal standardized neurological examinations will be performed. Longitudinal     samples of serum, plasma, and lymphocytes may be obtained from participants. Lumbar punctures     may be performed on all participants. These samples will be used virological and     immunological assays. A focus is on the relationships between the characteristics of viral     infection, the immune response, and the genetic makeup.   "
162587|NCT00001780|"     Transcranial Magnetic Stimulation (TMS) is a non-invasive technique to gather information     about brain function. It is very useful when studying the areas of the brain related to motor     activity (motor cortex, corticospinal tract, spinal cord and nerve roots). The procedure is     conducted by transmitting a magnetic signal into the brain to stimulate an area of the body.     Electrodes (small pieces of metal taped to areas of the body) are used in order to measure     electrical activity. A magnetic signal is sent from a metal instrument held close to the     patient's head, to an area of the brain responsible for motor activity of a certain area of     the body. The electrodes pick up and record the electrical activity in the muscles.      This study will employ the use of TMS to diagnose neurological disorders that affect the     motor cortex or the corticospinal tract. Normal subjects are sometimes studied to investigate     normal activity of the nervous system and to train doctors in clinical neurophysiology and     electrodiagnostic medicine at the National Institutes of Health (NIH).   "
162734|NCT00001982|"     Hepatitis C is a disease of the liver caused by the Hepatitis C Virus (HCV). Patients with     hepatitis C may feel well and show no signs or symptoms of being ill. However, researchers     would like to study the long-term effects of this disease.      Volunteer blood donors diagnosed with chronic hepatitis C viral (HCV) and various levels of     liver enzyme activity will be offered a complete medical evaluation and liver biopsy. The     tests will enable researchers to provide the patients with an idea of how severe their liver     disease is. The virus and patient will be studied in order to understand why patients with     hepatitis C develop different levels of liver damage.   "
162588|NCT00001781|"     Multiple sclerosis (MS) is a disease of the nervous system. The exact cause of MS is unknown,     but it is believed to be an autoimmune condition. Autoimmune conditions are diseases that     cause the body's immune system and natural defenses to attack healthy cells. In the case of     MS, the immune system begins attacking myelin, the cells that make up the sheath covering     nerves. Without myelin nerves are unable to transmit signals effectively and symptoms occur.      Researchers are interested in testing the safety, tolerability, and effectiveness of a new     therapy (CGP77116) for Multiple Sclerosis (MS). CGP77116 is a small protein similar to the     protein in myelin. CGP77116 is designed to modify the immune reaction that destroys normal     myelin. CGP77116 is an experimental therapy meaning it has not been approved by the U.S. Food     and Drug Administration. However, in preliminary studies on animal it has been shown to be     effective at modifying the autoimmune reaction associated with the development of MS.      The purpose of this study is to assess the safety and effect of CGP77116 on disease activity     in patients with Multiple Sclerosis as measured by magnetic resonance imaging (MRI) and     immunological studies.      The study is broken into three parts:      I) BASELINE: in the first part of the study patients will undergo 6 MRIs over a 5 month     period. During this time, patients will be evaluated based on the presence of MS lesions seen     on MRI. Patients whose MS lesions are highly active will be entered into the second part of     the study.      II) TREATMENT: in the second part of the study, patients with active MS lesions will begin     receiving CGP77116. The drug will be given by injection once a week for one month and then     once a month for 8 additional months.      III) FOLLOW-UP: in the third and final part of the study, patients will undergo an MRI every     2 months for 6 months and then every 3 months for 6 additional months. The results of the     MRIs will be used to measure the effectiveness of CGP77116.   "
162589|NCT00001782|"     The human brain is made up of two halves called hemispheres. Each half of the brain is     responsible for processing different kinds of information. Previous neuroimaging studies have     shown that both the right and left hemispheres are involved when processing information given     in American Sign Language (ASL). However, the study also showed that when processing spoken     language, the left hemisphere was mostly involved.      Researchers would like to find out more about how the brain processes American Sign Language     (ASL). This study is designed to determine if the right hemisphere is necessary for normal     understanding of ASL.   "
162590|NCT00001783|"     The purpose of this study is to determine if giving amphetamines along with standard     rehabilitation speeds motor recovery after a stroke. In addition, if motor recovery is     improved, the study will also identify the areas of the brain involved with the recovery.      Researchers will use motor function ratings, PET scans, functional MRI (fMRI),     electroencephalographs, and transcranial magnetic stimulation (TMS) to evaluate patients.      Patients participating in the study will be placed in one of two groups;        1. Patients receiving dextroamphetamine and routine Rehabilitation Medicine        2. Patients receiving a placebo sugar pill and routine Rehabilitation Medicine      Patients that have improved motor recovery will undergo neuroimaging and neurophysiological     studies to identify areas of the brain involved.   "
162591|NCT00001784|"     Dystonia refers to a condition characterized by involuntary muscle contractions that may     cause pain, abnormal posture, or abnormal movements. The cause of dystonia is unknown, but     some researchers believe it is a result of overactivity in the areas of the brain responsible     for movement (basal ganglia).      Lidocaine is a drug used for the treatment of irregular heartbeats. It is given by injection.     Recent studies have shown that lidocaine is also effective for the treatment dystonia.     Mexiletine is a drug similar to lidocaine used for irregular heartbeats that can be taken by     mouth.      Researchers would like to test the effectiveness of Mexiletine for the treatment of dystonia.     Patients participating in the study will be divided into two groups;      Group 1 will take Mexiletine for six weeks then stop. They will remain drug free for one week     then begin taking a placebo inactive sugar pill for an additional six weeks.      Group 2 will take a placebo inactive sugar pill for six weeks then stop. They will remain     drug free for one week then begin taking a Mexiletine for an additional six weeks.      Throughout the study researchers will test the effectiveness of the treatment by evaluating     patients using clinical rating scales and neurophysiological studies. In addition,     researchers will test patient's reflexes in an attempt to find out where mexiletine works in     the nervous system.   "
162759|NCT00002415|"     The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new     anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV     drugs in the past. Genetic response will be studied.   "
162760|NCT00002416|"     The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when     given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug.   "
199372|NCT00457223|"     The purpose of this study is to compared between conventional pterygium excision and AMT     transplantation with suture and with fibrin glue.   "
162592|NCT00001785|"     HTLV stands for human T cell leukemia virus. HTLV-1 is a virus that attacks specific kinds of     white blood cells called T cells. T cells are part of the natural defense system of the body.     HTLV-1 has been associated with leukemia and lymphoma. In addition, approximately 1% of all     patients infected with HTLV-1 develops a condition known as HTLV-1 associated myelopathy     (HAM) / tropical spastic paraparesis (TSP).      Currently there is no clearly defined, effective treatment for patients with HAM/TSP.     Steroids have been used as therapy but have only been able to provide temporary relief of     symptoms. Human interferon is a small protein released from different kinds of cells in the     body. Interferon has been known to have antiviral and immunological effects and has been used     to treat hepatitis and multiple sclerosis. Interferon Beta is released from cells called     fibroblasts. These cells play a role in the production of connective tissue.      The purpose of this study is to evaluate the possible role of recombinant interferon beta     (Avonex) in treatment of HAM/TSP. The study is broken into three phases, a pre-treatment     phase, a treatment phase, and a post-treatment phase. The total duration of the study will be     44 weeks.      Patients participating in this study will receive injections of Avonex 1 to 2 times a week.     Throughout the study patients will regularly submit blood samples and undergo diagnostic     tests such as MRI and measures of somatosensory evoked potentials.   "
162593|NCT00001788|"     The purpose of this study is to evaluate patients with primary immunodeficiency disorders to     identify patients with mutations of the genes for the following proteins: Jak3, STAT1, STAT4,     interleukin-7, interleukin-7 receptor, interleukin-12 receptor subunits, and others.      Patients will undergo screening history, physical examination, and clinical laboratory     evaluation at referring institutions and tissue samples, or cell lines will be sent to the     NIH. We will establish cell lines if necessary, prepare DNA and RNA for molecular genetic     analysis and study cytokine signal transduction in patient cell lines.   "
162858|NCT00002538|"     RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for ovarian,     primary fallopian tube, and primary abdominal cancers.      PURPOSE: Phase II trial to study the effectiveness of laparoscopic staging in patients with     ovarian, primary fallopian tube, or primary abdominal cancers who have not undergone complete     staging.   "
162594|NCT00001789|"     The purpose of this study is to investigate whether the experimental drug BG9588 can be used     to treat lupus nephritis more effectively and with less toxicity than standard treatments,     including cyclophosphamide (Cytoxan), azothioprine (Imuran) and prednisone.      The body's immune system naturally produces antibodies to fight foreign substances like     bacteria and viruses. In autoimmune diseases like lupus, however, the body makes antibodies     that attack its own tissues, causing inflammation and organ damage. Lupus antibodies attack     and damage kidney cells. BG9588 can interfere with the production of these antibodies, and     therefore, may lessen kidney damage in people with lupus nephritis.      This study will look at: how BG9588 enters and leaves the blood and body tissue over time;     adverse effects of the drug; and whether treatment with BG9588 can result in less kidney     damage than other therapies.      Study patients will be receive a 30-minute infusion of BG9588 into a vein every two weeks for     three doses and then once every 28 days for four doses. Patients' steroid dosage may be     tapered; individual adjustments will be made as required.      Patients screened for the study will undergo a physical examination, medical history, various     blood and urine tests, as well as complete a quality of life questionnaire. Results of a     previous kidney biopsy and chest X ray are also required. Many of these tests will be     repeated throughout the study.      In a previous animal study, BG9588 treatment of mice with lupus nephritis improved their     disease and survival.   "
162595|NCT00001790|"     The objective of this study is to evaluate the safety, tolerance, and pharmacokinetics of     FK463, a novel echinocandin (cell wall-active antifungal lipopeptide), as early empirical     therapy for prevention of fungal infections in immunocompromised children. The study is     designed as a multicenter open label, sequential dose escalation study of intravenous FK463.     Intravenous FK463 will be administered daily as an hour infusion to patients with new onset     of fever and neutropenia (absolute neutrophil count less than or equal to 500/mm3) who will     be initiated onto broad spectrum empirical antibacterial therapy. The patient population     consists of children ages 2 to 17 years of age; two age cohorts will be studied (2-12,     13-17). Dosage levels will be 0.5mg/kg/day (not to exceed 25 mg/day), 1.0 mg/kg/day (not to     exceed 50 mg/day), 1.5 mg/kg/day (not to exceed 75 mg/day) and 2.0mg/kg/day (not to exceed     100mg/day). The planned sample size is 64 patients (a maximum of two replacement patients may     be added to a given dose level and age cohort, for a total of no more than 10 patients per     dose level and age cohort. The study will enroll no more than 80 patients). At each dosage     level, a total of 8 patients will be enrolled into each age cohort (2-12, 13-17); a total of     16 patients will be enrolled into each dosage level. The first group of patients will receive     FK463 at 0.5 mg/kg/day (not to exceed 25 mg/day). The second group of patients will receive     1.0 mg/kg/day (not to exceed 50mg/day). The third group of patients will receive 1.5     mg/kg/day (not to exceed 75 mg/day). The fourth group of patients will receive 2.0mg/kg/day     (not to exceed 100mg/day). Study drug will continue until recovery from neutropenia (ANC post     nadir greater than or equal 250/mm3) or until the initiation of conventional deoxycholate     amphotericin B or a lipid formulation of amphotericin B for empirical antifungal therapy or     for proven fungal infection. Patients may receive FK463 for a maximum duration of 14 days.     For any patient who meets institutional criteria to start standard empirical antifungal     therapy with conventional deoxycholate amphotericin B or a lipid formulation of amphotericin     B (greater than 96 hours on study drug) or who has a proven breakthrough fungal infection,     FK463 will be discontinued and conventional deoxycholate amphotericin B or a lipid     formulation of amphotericin B will be initiated.   "
162596|NCT00001797|"     Several studies have documented an essential role for interleukin-10 (IL-10) in preventing     prolonged and exaggerated immune responses to antigens and irritants. Psoriasis, a relatively     common disease, is characterized by T cell-mediated inflammation in affected skin. In this     study, the safety, tolerance, immunologic effects, and clinical activity of subcutaneous (SC)     recombinant human (rh) IL-10 will be evaluated in patients with moderate-to-severe psoriasis.     There will be 2 groups of patients, randomized to receive either 20 ug/kg rhIL-10 SC 3 times     weekly (20 patients) or SC placebo (10 patients). This double-blind phase will continue for a     total of 12 weeks and the principal evaluation will be the comparison between baseline and 12     week Psoriasis Area Severity Index (PASI) scores. Patients will come for an initial screening     visit at day 0, and at weeks 1, 2, 4, 6, 8, and 12, with follow-up visits at weeks 16 and 20.      All patients will be offered rhIL-10 at 12 weeks (following the blinded portion of the study     protocol). Patients initially receiving active medication who wish to continue rhIL-10     therapy will be kept on the drug. This open-label portion of the study will continue for an     additional 12 weeks. Patients continuing with active drug will be evaluated at weeks 14, 16,     20, and 24.      Skin disease activity and toxicity will be assessed and recorded throughout the study. In     addition, research studies will include functional assays to assess cytokine secretion and     immunologic function of peripheral blood cells and immunohistochemical characterization of     the inflammatory cells in skin.   "
162761|NCT00002417|"     The purpose of this study is to see if it is safe and effective to give the protease     inhibitor (PI) amprenavir (APV) to patients with fat production and distribution problems     associated with other PIs.      Protease inhibitors are very effective in treating HIV-1 disease. However, patients who take     these drugs often have problems, such as hyperlipidemia (an increased level of fat in the     blood) and lipodystrophy (problems with the way fat is produced and distributed in the body).     Doctors do not know exactly how PIs are related to these problems. APV has been shown to be     safe and effective in lowering plasma viral loads (level of HIV in the blood). APV may be     useful for patients who develop complications associated with other PIs.   "
162597|NCT00001803|"     The Von Hippel-Lindau (VHL) Disease Genetic Epidemiology Study is a family-based case-control     study to be conducted by the National Cancer Institute. The study subjects are 603     individuals who were determined to belong to families with VHL disease confirmed through     screening under NIH protocol #89-C-0086 between 1988 and 1998. There are 293 patient     volunteers with VHL disease and 310 volunteer patients free of VHL disease, most of whom have     already had genetic testing for mutations in the VHL gene. Adults as well as children aged 13     - 17 will be included. All subjects will give informed consent prior to participation; for     minor subjects, assent will be obtained from the minor and consent from the parent/guardian.     This protocol provides the potential to benefit people with VHL disease (although not     necessarily the study subjects themselves) and possibly people with sporadic (non-hereditary)     forms of the tumors which occur in VHL disease. The risks and discomfort associated with this     study are minor.      The present protocol is a new epidemiologic component to VHL research at NIH which will     relate the expression of VHL tumors to lifestyle factors (tobacco and alcohol use; physical     activity), occupational exposures, reproductive and hormonal factors, demographic factors,     medication use, diet, and putative susceptibility genes. Information will be collected by     telephone interview and a written, self-administered diet questionnaire. A cheek cell sample     will be obtained for analyses of genetic polymorphisms. Medical records will be obtained to     document events reported by the subject at interview. Primary comparisons will be between VHL     patients with a particular manifestation and VHL patients who are free of that condition.     Additional comparisons may be made with unaffected family members who lack a mutation in the     VHL gene, as appropriate.   "
162598|NCT00001805|"     This is a phase II clinical and pharmacokinetic study of suppression of human antimouse     (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The     primary objective of this study is to determine the effect of Rituximab on HAMA and HATA     response to LMB-1 administered to patients with advanced carcinoma that express the B3     antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.   "
162929|NCT00002621|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells.      PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating children     with an HIV-related cancer including leukemia, non-Hodgkin's lymphoma, CNS lymphoma, or other     solid tumors.   "
162599|NCT00001806|"     In 1997, the Genetics Department of the NCI Medicine Branch helped establish a breast cancer     genetics program at the National Naval Medical Center s Breast Care Center. Genetic     education, counseling, and germline testing for BRCA1 and BRCA2, two genes which confer     increased lifetime risks for breast and ovarian cancer, were offered under a Navy     IRB-approved study. Sixty participants received education and counseling on that protocol, 49     of whom chose to have genetic testing. The education and counseling, provided by oncology     nurses trained in cancer genetics, focused on preparing participants to make well-informed     decisions about testing. Included were information on cancer and genetics; hereditary     breast/ovarian cancer syndrome; risks, benefits and limitations of BRCA1/BRCA2 testing; and     screening and risk reduction options for high-risk individuals. Through our experience with     this study, we devised two different methods of providing this information. Both of these     methods were well received and appear to be equally effective, as measured by knowledge     assessments before and after the sessions and subjective evaluation by the participants. We     will now study them in a randomized fashion in the current protocol, to better evaluate     whether one method is preferable. Ultimately we hope to be able to make recommendations that     will allow for access to genetic education and counseling for more individuals in a more cost     efficient manner.   "
162600|NCT00001807|"     Central nervous system toxicity is a recognized side effect of certain therapies for cancers,     particularly cranial irradiation, intrathecal therapy or systemic high-dose chemotherapy. The     pathophysiologic mechanisms and clinical manifestations vary. Previous studies defining MRI     changes and correlating these with neurocognitive deficiencies have been inconsistent. Recent     advances in brain imaging may help to better define neurotoxic effects. (1)H-NMRS is a     noninvasive method of obtaining in vivo biochemical information from the brain. It has been     used to study patients with CNS disorders, including neuronal disorders. In this study,     (1)H-NMRS will be used to objectively characterize CNS toxicities in patients with cancer who     are receiving potentially neurotoxic therapies. In addition, we will retrospectively evaluate     patients with known or suspected neurotoxicity associated with cancer therapy, to determine     if changes in spectroscopic patterns are associated with CNS toxicity.   "
162601|NCT00001810|"     The objective of this study is to evaluate the efficacy, safety and toleration of     voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal     pathogens for which there is no licensed therapy; and in the secondary treatment of systemic     or invasive fungal infections in patients failing or intolerant to treatment with approved     systemic antifungal agents. This trial is a Phase II multicenter, open label study     investigating the utilization of voriconazole for the treatment of systemic or invasive     fungal infections. Enrollment is targeted for 150 patients to be recruited from multiple     centers. The patient population will consist of patients with proven, deeply invasive fungal     infection for which there is no licensed therapy or if the patient is failing or intolerant     to treatment with approved systemic antifungal agents. Voriconazole will be administered     initially by a loading dose of 6 mg/kg q12 hours for the first two doses followed by 4 mg/kg     q12 hours. Efficacy will be evaluated by clinical, radiological and microbiological response.   "
162602|NCT00001812|"     In patients who are receiving intravenous high dose Interleukin-2, patients will be     randomized into two groups: group one will receive nystatin swish and swallow immediately     before initiation of IL-2, and the second group will receive a placebo. The patients in each     group will be monitored and evaluated for differences in the rate and severity of development     of oral irritation during treatment. They will also be studied for differences between the     two groups in the number of doses of IL-2 taken.   "
162603|NCT00001813|"     Four rare genetic diseases, xeroderma pigmentosum (XP), Cockayne syndrome (CS), the XP/CS     complex and trichothiodystrophy (TTD) have defective DNA excision repair although only XP has     increased cancer susceptibility. We plan to perform careful clinical examination of selected     patients with XP, XP/CS, CS, or TTD and follow their clinical course. We will obtain tissue     (skin, blood, hair, buccal swabs) for laboratory examination of DNA repair and for genetic     analysis. We hope to be able to correlate these laboratory abnormalities with the clinical     features to better understand the mechanism of cancer prevention by DNA repair. Patients will     be offered counseling and education for cancer control.   "
162762|NCT00002418|"     The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug     combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase     inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug     combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus     MKC-442. Hydroxyurea (HU) may be added.   "
162763|NCT00002419|"     The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil     plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who     have failed to respond to previous treatment with protease inhibitors (PIs).   "
162605|NCT00001816|"     This study seeks to evaluate the impact of Starbright World (SBW) on hospitalized children.     SBW is a virtual environment designed to link seriously ill children into an interactive     online community where they can play games, learn about their condition, or talk with other     ill children who are connected to the network. Our outcome evaluation of SBW will include     assessments of pain, mood (anxious, depressed and energetic), anger, loneliness, and     willingness to return to the NIH for treatment of children who are being treated at NIH. They     will be assessed while engaging in normal recreational activities (in one of two available     playrooms) and while using Starbright World. In addition, we will conduct a process     evaluation of the implementation of Starbright World.   "
162633|NCT00001860|"     The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered     Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with     macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels.     Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and     transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to     less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly,     reduce the size of the macroadenomas, produce few side effects, assess the prognostic value     of baseline pituitary adenoma size, extension and baseline growth hormone level on     post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each     treatment type.   "
162606|NCT00001818|"     This study will test the safety and effectiveness of hydroxyurea, an anti-cancer drug, given     together with the anti-HIV drugs didanosine, stavudine and efavirenz for treating children     infected with human immunodeficiency virus (HIV). Some studies have found that hydroxyurea     may help certain anti-HIV drugs to work better and that the virus does not become resistant     to it, as it does other drugs. This study will also examine how hydroxyurea affects the     body's immune system and virus levels.      Patients 3 through 21 years old with HIV infection may be eligible for this 52-week study.     They will be screened for eligibility with a thorough physical examination, including chest     X-ray, electrocardiogram and echocardiogram, head CT scan, eye examination and blood tests.      All patients in the study will take didanosine twice a day, stavudine twice a day and     efavirenz once a day. All patients will also take hydroxyurea twice a day, but some will take     a low dose of the drug, while others will take a high dose. Within each of these two groups     (high and low dose) some patients will start taking hydroxyurea the same day they begin the     anti-HIV drugs; others will not start hydroxyurea until after they have taken the anti-HIV     drugs for 5 weeks. Patients will have a physical examination every 3 weeks until week 12,     then every 4 weeks until week 24, and then every 8 weeks until the end of the study. Blood     tests to measure virus levels will be done every other day for the first 7 days and     periodically after that. For the first 8 weeks after starting hydroxyurea, blood tests will     be done weekly. An eye examination, chest X-ray, electrocardiogram, and CT scans of the head     will be done about every 6 months.   "
162607|NCT00001823|"     Background:      The NCI Surgery Branch has developed experimental therapies that involve taking white blood     cells from patients' tumor or from their blood, growing them in the laboratory in large     numbers, and then giving the cells back to the patient.      Objective:      This study will allow patients to under screening and evaluation for participation in NCI     Surgery Branch Protocols      Eligibility:      Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment     Protocol      Design      Patients will undergo testing and evaluations as required by the appropriate NCI Surgery     Branch Treatment protocol   "
162608|NCT00001826|"     This study will continue to follow children who participated in an earlier National Cancer     Institute trial of HIV treatment with a protease inhibitor. Children in this study will     receive a combination of at least three drugs that include at least one protease inhibitor     and one reverse transcriptase inhibitor.      The study will examine to what extent these drugs can restore immune function in HIV-infected     children and over what length of time. It will look at changes in the amounts of virus and     the specific types of immune cells in the body over the 96-week trial period. It will also     examine patients' immune system response to influenza and tetanus vaccinations.      The children will either continue to receive the anti-HIV drugs they have been taking, or     their medicines will be changed to a different combination of protease inhibitor and reverse     transcriptase inhibitor. Before and during the study, patients will undergo various tests,     including a physical examination, blood tests and chest X ray, immune response tests, CT     scan, eye examination, electrocardiogram and echocardiogram. A procedure called apheresis may     be done to collect white blood cells. In this procedure, whole blood is drawn similar to     donating blood, the white cells are separated out by a machine, and the red cells are     returned to the body.   "
162609|NCT00001827|"     This study will examine whether vaccination with a p53 peptide can boost an immune response     to ovarian cancer and what the side effects are of the vaccine.      Many patients with ovarian cancer have an altered (mutated) gene called p53 that causes the     production of abnormal proteins found in their tumor cells. The body s immune system may try,     unsuccessfully, to fight these abnormal proteins. In this study, ovarian cancer patients with     a p53 abnormality will be vaccinated with a p53 peptide a part of the same abnormal protein     found in their tumor to try to boost their body s immune response to the cancer.      Patients will be divided into two groups. Group A will have four p53 peptide vaccinations     three weeks apart, injected under the skin. The injection will include a drug called ISA-51,     which increases the effect of the vaccine. This group will also receive two other drugs that     boost the immune system, IL-2 and GM-CSF. Group B will have four p53 peptide vaccinations     three weeks apart. The peptide will be mixed with the patient s own blood cells and infused     into a vein. This group will also receive IL-2, but not GM-CSF.      All study candidates will be tested to see if their cancer has a p53 abnormality and if their     immune system mounted a defense against it. These tests may include a tumor biopsy (removal     of a small part of the tumor for microscopic examination); lymphapheresis (a procedure to     take blood, remove white blood cells called lymphocytes, and return the red cells); and an     immune response test similar to a skin test for tuberculosis. During the study, patients will     have additional skin tests and blood tests.   "
162610|NCT00001830|"     Allogeneic peripheral blood stem cell transplantation (PBSCT) is primarily limited by     graft-versus-host disease (GVHD). In murine models, we have demonstrated that donor CD4+ T     cells of Th1 cytokine phenotype (defined by their secretion of IL-2 and IFN-gamma) mediate     GVHD. In contrast, donor CD4+ T cells of Th2 phenotype (defined by their secretion of IL-4,     IL-5, and IL-10) do not generate GVHD, and abrogate Th-1-mediated GVHD. Importantly, we have     demonstrated that enrichment of murine allografts with Th2 cells reduces GVHD without     impairing the ability of donor T cells to prevent graft rejection. These studies indicate     that the administration of Th2 cells after allogeneic transplantation represents a strategy     for achieving alloengraftment with reduced GVHD.      In addition to GVHD, allogeneic PBSCT has been limited by the toxicity associated with     conventional myeloablative preparative regimens. Such regimens, which typically utilize total     body irradiation (TBI) and high-dose chemotherapy, were once considered essential for the     prevention of graft rejection. However, recent clinical studies have shown that     non-myeloablative doses of fludarabine-based chemotherapy can result in alloengraftment. In     murine models, we have demonstrated that severe host T cell depletion induced by combination     fludarabine and cytoxan can prevent even fully-MHC mismatched marrow graft rejection.     Although non-myeloablative regimens may reduce regimen-related toxicity, such transplants     have been associated with a 30 to 40% incidence of severe acute GVHD that is similar to rates     observed with myeloablative regimens. Because non-myeloablative regimens appear to be     associated with reduced regimen-related toxicity, we have elected to conduct this phase I     study of Th2 cells in the setting of an immunoablative (non-myeloablative) preparative     regimen.      Patients with leukemia in clinical remission, and patients with refractory lymphoid     malignancy will be candidates for this HLA-matched allogeneic PBSCT protocol. Patients will     receive novel induction regimen (fludarabine and EPOCH) and transplant preparative regimen     (fludarabine and cytoxan) designed to maximally deplete host immune T cells capable of     mediating graft rejection. After induction and preparative regimen chemotherapy, patients     will receive an unmanipulated, G-CSF mobilized PBSC graft. In the initial six patients     receiving this transplant procedure at the NCI, graft rejection has been successfully     prevented (100% donor chimerism by day 30 post-transplant). Importantly, GVHD has been     observed in all six patients, with three of the six patients developing severe GVHD (grade     III). Given that this regimen successfully achieves donor engraftment, and is associated with     significant GVHD, this transplant regimen represents an excellent clinical setting for the     evaluation of Th2 cells.      Using this non-myeloablative allogeneic PBSCT approach, we will perform a Phase I study to     evaluate the safety and feasibility of administering donor Th2 cells on day 1     post-transplant. Prior to transplantation, donor CD4+ T cells will be stimulated in vitro     using culture conditions that support the generation of donor CD4 cells of the Th2 cytokine     profile. If this Phase I study demonstrates that Th2 cell administration is safe and     feasible, a Phase III study will be performed to evaluate whether Th2 cell administration     reduces the incidence and severity of GVHD. Successful implementation of this Th2 strategy     will greatly reduce the morbidity and mortality associated with allogeneic PBSCT, and may     also represent an approach to stem cell transplantation in patients lacking an HLA-matched     donor.   "
162616|NCT00001840|"     This project will investigate the evolution of treated and untreated stroke in patients     recruited from the collaborative brain stroke program between NINDS, CC, and Suburban     Hospital. The study will use anatomical and functional imaging techniques with emphasis on     the acute and subacute stage (less than one month) of the disease.      As the availability of new therapeutic options for the management of acute brain stroke     increases, the need to define the evolution of the disease becomes paramount, particularly as     therapeutic windows, defined by known and perhaps yet undiscovered parameters, may exist.     Defining these parameters will be based on state-of-the-art imaging technology with the     potential of clarifying the division between ischemia (reversible damage) and infarction     (irreversible). Measures of lesion size and distribution along with vascular morphology,     diffusion, perfusion, flow-related, and metabolic measures will be obtained over time. We     foresee these measurements will significantly develop our understanding of cerebral ischemia     and introduce diagnostic and quantitative tools to guide therapy and measure its efficacy.   "
162792|NCT00002459|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known whether receiving radiation therapy or no further therapy after surgery is more     effective for cancer of the uterus.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with     that of no further therapy in treating patients who have stage I or stage II cancer of the     uterus that has been surgically removed.   "
163443|NCT00003551|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients     with stage III, stage IV, or recurrent kidney cancer.   "
162611|NCT00001832|"     This experiment will test the safety and effectiveness of a treatment for melanoma in which     certain lymphocytes (a type of white blood cell) are taken from the patient, grown in the     laboratory, and returned after the patient's immune system has been weakened with     immune-suppressing drugs. Some patients will also receive interleukin-2 (IL-2), a drug that     may enhance the activity of the re-infused lymphocytes.      Patients with metastatic melanoma (melanoma whose tumor has spread) who have been treated     unsuccessfully with gp100 vaccination may participate in this study. They will undergo     apheresis or a tumor biopsy, or both, to collect lymphocytes. In apheresis, whole blood is     drawn through a needle in the arm. A machine separates the blood components and removes the     white cells. The rest of the blood is returned to the donor through a needle in the other     arm. A biopsy is a surgical procedure to remove a small piece of tumor tissue.      Several weeks before the lymphocytes are collected, patients will receive injections of     growth colony stimulating factor (G-CSF) every day for five days. This drug stimulates white     cell production, permitting as many cells as possible to be obtained during collection. The     lymphocytes will then be grown in larger numbers in the laboratory.      Seven days before the cells are re-infused, the patient is admitted to the hospital and a     catheter (small tube) is placed in a large vein in the chest or neck. Two drugs,     cyclophosphamide and fludarabine, are given through the tube. These drugs suppress the immune     system so that it will not interfere with the work of the reinfused lymphocytes. The     lymphocytes are then injected through the catheter over a 30-minute period. After the     infusion, patients who receive IL-2 will be given the drug in a high dose over a 15-minute     period every eight hours for up to five days. Patients whose condition does not permit     high-dose IL-2, such as those with a heart condition or lung problem, may receive a low-dose     regimen, with the drug given as a shot under the skin of the thigh or abdomen for five days     followed by a 2-day break, continuing for a total of six weeks. These patients receive a     higher dose the first week and then half that dose the next five weeks.      Blood and tissue samples will be taken before and during the study to evaluate the size of     the tumor and assess treatment. If, 3-5 weeks after therapy is completed, the patient's tumor     has stabilized or shrunk, the entire treatment, except for chemotherapy, may be repeated two     more times.   "
162612|NCT00001835|"     Oxaliplatin is an experimental anti-cancer drug that can shrink tumors such as colon cancer.     However, because this drug can damage the kidneys, it is necessary to determine what doses of     the drug can safely be given to patients with poor kidney function.      Patients with advanced cancer, poorly functioning kidneys, and no good standard treatment     options are eligible for this study. Candidates will be screened with imaging tests, such as     CT and MRI scans, to determine the size and location of the cancer and with blood and urine     tests to evaluate kidney and liver function.      Study participants will receive oxaliplatin intravenously (through a vein) every 3 weeks for     as long as the cancer is under control and there are no serious side effects from the drug.     If significant side effects develop, the dosage will be reduced, or the drug will be stopped.     Blood tests to measure blood cell counts will be done at least once a week, and CT scans,     chest X-rays, and MRIs will be done about once every 6 weeks to assess the tumor's response     to the treatment. Additional blood tests will be done at the beginning of the first two     treatment cycles to measure the amount of oxaliplatin in the blood, and urine will be     collected during the first 24 hours of drug treatment to determine how much drug is     eliminated by the body in urine.   "
162613|NCT00001836|"     Electron beam computed tomography (EBCT) has been regarded as the state-of-the-art     investigation for detecting and quantitating coronary artery calcification. However, EBCT is     expensive, and the asymmetric gantry geometry makes it less useful for routine scanning;     thus, EBCT is not readily available to the general population. Recent reports have shown that     volumetric (also known as helical or spiral) scanners, which are much more commonly     available than EBCT, can detect coronary artery calcifications. Updated software available to     the NIH which will allow for EKG gating of volumetric scans should improve the quality of the     images, and thus improve the ability to accurately quantitate coronary calcification by     volumetric scanners. We would like to compare the results of volumetric scans with that of     standard EBCT in order to characterize similarities and differences between the two scanning     techniques. We propose to obtain EBCT and volumetric CT scans of the coronary arteries in a     group of patients with known or suspected coronary artery disease and to calculate the     calcium score by each method. Our primary analysis will be a comparison of the sensitivities     of the two methods.   "
162614|NCT00001837|"     This research study is designed to work in cooperation with another study being conducted by     the National Cancer Institute. The National Cancer Institute (NCI) is studying the effects of     a drug called raloxifene on premenopausal women believed to have a high risk of developing     breast cancer (98-C-0123).      In this study, researchers are interested in learning about the effects of raloxifene on the     uterus and ovaries of the women participating in the NCI study. To do this researchers plan     to conduct ultrasounds on the patients enrolled in the NCI study. In addition researchers     plan to take samples of the lining of the uterus in these patients (endometrial biopsy) if     found to be necessary.      The purpose of this study is to determine the reproductive effects of raloxifene on women who     have normal functioning ovaries by taking ultrasounds of the ovaries and lining of the uterus     (endometrium).   "
162615|NCT00001839|"     Approximately 40% of the patients with myelodysplastic syndrome (MDS) die as a consequence of     their cytopenia. As in aplastic anemia, the cytopenia of MDS may be partly due to cytotoxic T     cell activity. Immunosuppressive therapy may therefore reverse the cytopenia. In a phase II     pilot study of anti-thymocyte globin (ATG) to treat myelodysplastic syndrome (MDS); 41% of     patients (61% of patients with refractory anemia) have responded in terms of transfusion     independence. Recently, Jonasova et al [32] reported a 82% substantial hematological response     rate in 18 patients with MDS of the refractory anemia (RA) subtype treated with cyclosporine     alone. Just over 50% of the patients in this series had MDS of the hypocellular type.     Cyclosporine alone if indeed efficacious would be a powerful therapeutic option that could be     readily used by hematologists in the community to treat patients with MDS. This efficacy     needs to be proven in a larger study which includes patients with the other subtypes of MDS     and more patients with the non-hypocellular forms of MDS (which constitute approximately 70%     of the cases in the community). As MDS is a heterogeneous group of disorders, a randomized     comparison with the other immunomodulating intervention of proven benefit, ATG, is     appropriate. In this randomized study patients with MDS will receive either ATG alone or     cyclosporine alone.   "
162764|NCT00002420|"     The purpose of this study is to see if it is safe and effective to give MKC-442, didanosine     (ddI), stavudine (d4T), and delavirdine (DLV) to HIV-positive patients.   "
162765|NCT00002422|"     The purpose of this study is to see if it is safe and effective to give HE2000, an     experimental anti-HIV drug, to HIV-infected patients on salvage therapy (emergency treatment     used when a patient has not responded to standard therapy).      HE2000 is a hormone that is suspected to make it more difficult for HIV to live in cells.   "
162766|NCT00002423|"     This study will compare the safety and effectiveness of two anti-HIV drug combinations in     fighting HIV infection in patients whose viral loads (levels of HIV in the blood) rose with     other anti-HIV drug treatments.   "
162618|NCT00001842|"     This study will examine the feasibility of giving cell growth stimulants to granulocyte     donors the same day of donation rather than the day before.      People who donate granulocytes (infection-fighting white blood cells) for transfusion to     patients with severe white cell deficiencies are often given a steroid called dexamethasone     and a growth factor called G-CSF the day before donation. These drugs stimulate white cell     production, allowing many more cells to be collected than would otherwise be possible. A     single dose of G-CSF given to healthy people increases their white cells counts by four to     five times the next day.      It would be preferable, however, to give G-CSF the same day of donation, if possible.     Therefore, this study will measure white cell counts in healthy people at various intervals     after being injected with G-CSF alone and G-CSF with dexamethasone. The study will compare     the following: granulocyte counts at seven different intervals after injection of the drug or     drugs; the effects of G-CSF injected through a vein or under the skin; and the effects of     giving G-CSF alone or with dexamethasone.      Each participant will undergo four procedures, each four weeks apart as follows: donate a     small blood sample; receive an injection of G-CSF under the skin or into a vein; and take     either two dexamethasone tablets or two placebo tablets.      Small blood samples will then be drawn 1, 2, 4, 6, 8, and 24 hours after the drugs are given.     Participants will answer questions about how they feel before the drugs are given and at the     various intervals after taking the drugs.   "
162619|NCT00001844|"     This study will evaluate new magnetic resonance imaging (MRI ) methods using a MRI machine     more powerful than those in most hospitals. MRI is a diagnostic tool that uses a large magnet     and radio waves to produce images of the human body. It can also provide information about     brain chemistry and physiology. This study will use the new MRI hardware and methods to     measure blood flow and metabolism in regions of the brain during simple tasks, such as     listening to tones or watching flashing checkerboards.      Healthy normal volunteers will undergo MRI scanning. For this procedure, the person lies on a     stretcher that is moved into a MRI machine, which produces a strong magnetic field. A special     lightweight coil is placed on the person's head to obtain better pictures. The scan time     ranges from 20 minutes to 2 hours, with the average scan lasting between 45 and 90 minutes.      During the MRI, the person may be asked to perform simple tasks, such as listening to tones     or watching a screen, tapping fingers or moving a hand. More complex tasks may require     thinking about tones or pictures and responding to them by pressing buttons.      The images produced in this study will be compared with those produced using standard MRI.     The results will be used to develop improved imaging methods for better patient care and     research.   "
162620|NCT00001845|"     This study will evaluate magnetic resonance imaging (MRI ) methods for measuring changes in     the brain's blood flow during hypercapnia (a condition of excess carbon dioxide in the     blood). MRI is a diagnostic tool that uses a large magnet and radio waves to produce images     of the body without X-rays.      Healthy normal volunteers in this study may have as many as six MRI scans over a 2-year     period. For this procedure, the person lies on a stretcher placed in a strong magnetic field     produced by the MRI machine. During the scan, the person's blood carbon dioxide (CO2 ) levels     will be increased either by: 1) breathing air mixtures containing up to 5% CO2; or 2)     receiving an intravenous (I.V.) injection of a drug called acetazolamide.      Persons who breathe CO2 will have their heart rate, blood pressure and oxygen levels     monitored throughout the procedure. Those receiving acetazolamide will have the drug injected     intravenously (I.V.) into an arm vein. If the volunteer experiences any unpleasant side     effects from the CO2 or acetazolamide, the study will be stopped.      The information gained from this study will be used to develop better ways to study brain     function, possibly leading to better diagnostic and treatment methods.   "
162767|NCT00002424|"     This study will see how safe and effective against HIV the drugs L-756423 plus indinavir     (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The     study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and     effective as taking 2 smaller doses twice a day.   "
162768|NCT00002425|"     To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule     formulation (SQV-SGC) in combination with other antiretroviral drugs.   "
162769|NCT00002426|"     The purpose of this study is to see if it is safe and effective to give an experimental     anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to     patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.   "
162622|NCT00001848|"     Many women with lower abdominal pain have endometriosis. Endometriosis is a condition in     which the lining of the uterus (endometrium) is found outside of the uterus. The diagnosis of     endometriosis is usually made at surgery. The treatment of endometriosis includes medical and     surgical approaches alone or in combination. The hormone estrogen stimulates the growth of     the endometrium and may also stimulate the growth of endometriosis. Medical therapies that     act to decrease the level of estrogen can reduce the amount of endometriosis and pain. When     therapies are discontinued, symptoms often return. In addition, medical treatment for     endometriosis is expensive and is often associated with weak bones (osteoporosis) and hot     flashes as a result of low levels of estrogen.      Surgical treatment is removal or destruction of the endometriosis tissue. Studies show the     pain from endometriosis is relieved longer with tissue removal than with destruction.      This study was developed to see if surgery followed by daily doses of Raloxifene (Evista) is     effective in reducing pain, for a longer time than surgery in combination with a placebo     (inactive sugar pill) treatment. Raloxifene acts like estrogens in some tissues and not     like estrogens in others. Postmenopausal women receiving Raloxifene for the prevention of     osteoporosis had an increase in bone density and an improvement of their blood lipids (fat     content in the blood). However, unlike estrogen, Raloxifene does not promote the growth of     breast tissue or the uterus. If Raloxifene blocks estrogen action in the lining of the uterus     (endometrium) of reproductive age women, as it does in post-menopausal women, it may also     limit the growth of endometriosis and prevent the return of pain.   "
162793|NCT00002460|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by blocking the uptake of estrogen.      PURPOSE: Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or     ovarian ablation with goserelin or both in treating women with stage I or stage II breast     cancer.   "
176034|NCT00144560|"     This is an open-label, clinical pharmacology study to investigate drug-drug interaction in     patients with RA.   "
162623|NCT00001849|"     Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol.     Cortisol is produced in the adrenal gland as a response to the production of ACTH in the     pituitary gland.      Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic     production of the hormone ACTH. Meaning, the hormone is not being released from the normal     site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the     lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the     ACTH cannot be found even with the use of extensive imaging studies such as CT scans, MRIs,     and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source     of the hormone production is dependent on the changes of anatomy and / or the dose and     adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH     production often results in unnecessary pituitary surgery or irradiation.      Unlike the previously described tests, positron emission tomography (PET scan) has the     ability to detect pathologic tissue based on physiologic and biochemical processes within the     abnormal tissue.      This study will test whether [18-F]-fluorodeoxyglucose (FDG) or use of a higher dose of     [111In-DTPA-D-Phe]-pentetreotide can be used to successfully localize the source of ectopic     ACTH production.<TAB>   "
162624|NCT00001850|"     This study was designed to allow inpatient and outpatient evaluation of women with a variety     of reproductive and endocrine-related disorders for purposes of research and physician     education.      The evaluations may include ultrasound examinations, blood, saliva, and/or urine samples. In     some cases, specific laboratory or X-ray studies will be performed to confirm the diagnosis     or assist in the treatment of the patient. These additional tests will be conducted within     the guidelines of current gynecologic practice. In some cases, the patient will receive     medical or surgical treatment for their disorder.      The purpose of this study is to provide an opportunity for physicians to evaluate women with     medical conditions of reproduction. These evaluations and treatments will support clinical     training and research for the accredited training program in reproductive endocrinology at     the National Institute of Child Health and Human Development (NICHD).<TAB>   "
162625|NCT00001851|"     This study will evaluate the effectiveness of a new bone injection technique for treating     bone disease in patients with polyostotic fibrous dysplasia or McCune-Albright syndrome. In     these patients, some bones develop areas with much less mineral, making the bones more prone     to fracture or deformity and causing pain. This new treatment is intended to reduce the risk     of fracture, minimize deformities and improve overall function in these patients.      Patients 4 years of age and older with bone lesions that are highly likely to cause     significant pain and illness may be eligible for this 2-year study. Participants must be     simultaneously enrolled in NIDCR's research protocol 98-D-0145 (Screening and Natural History     of Patients with Polyostotic Fibrous Dysplasia and McCune-Albright Syndrome) or 98-D-0146 (A     Randomized, Placebo-Controlled Trial of Alendronate in the Treatment of Polyostotic Fibrous     Dysplasia and McCune-Albright Syndrome).      Within 14 days of the bone injection procedure, patients will have a medical history, routine     blood tests, urinalysis and check of vital signs (blood pressure, pulse and temperature) and     will complete a 30-minute quality-of-life questionnaire. Women of child-bearing potential     will have a pregnancy test. Patients who do not have recent X-rays and bone density scans     available for review will have new ones taken. When these studies are completed, patients     will undergo the bone injection procedure, followed immediately by bone densitometry and     coned-down X-rays, as follows:        -  Bone injection - Patients will be given an anesthetic either to make them sleepy or put          them to sleep completely. A portion of bone marrow will be withdrawn through a needle          inserted into the hip bone and, at the same time, abnormal bone in the arms and legs          will be sucked out using a needle. The abnormal bone will be replaced with a mixture of          bone marrow and collagen (connective tissue protein) injected into the hole in the bone.          The areas of injection will be closed        -  Bone densitometry - X-rays of the operated bone and opposite normal bone will be taken.        -  Coned-down X-rays - Magnified normal X-rays will be taken as close-ups of an active          lesion.      Patients will have a history and physical examination by their local physician or at NIH     every month for the first 4 months after the procedure. Every 6 months after the procedure,     patients will return to NIH for follow-up, including a physical examination and completion of     a quality-of-life questionnaire. Imaging studies of the injected site will be done 3, 6, and     12 months after the procedure.   "
162631|NCT00001858|"     This protocol facilitates the development of methods for determining whether transplant     recipients have developed immune hyporesponsiveness or tolerance towards their allograft.     These methods will involve the study of peripheral blood or biopsy tissue obtained at regular     intervals from patients receiving kidney or combined kidney-pancreas allografts at the Warren     G. Magnuson Clinical Center. In addition, patients that have previously received a kidney or     combined kidney-pancreas allograft will be evaluated using assays requiring peripheral blood     mononuclear cells and/or biopsies. Assays developed under this protocol will be used in     subsequent protocols to assess the effects of immune modulating treatment regimens and may     eventually be used to direct clinical care or guide the withdrawal of immunosuppressive     agents. However, patients enrolled in this protocol will not have any change in treatment     based solely on the assays developed without being enrolled in an additional study.   "
162770|NCT00002427|"     The purpose of this study is to compare the safety and effectiveness of 9 doses of HU in     order to find the best dose of HU to use with ddI and d4T in fighting HIV infection.      HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term control     of HIV. This combination can sharply decrease viral load (level of HIV in the body) with few     side effects, making it easy to take.   "
162626|NCT00001852|"     This study will follow patients with salivary gland dysfunction to identify the long-term     course of this disorder and its effects on the mouth, oral function, and overall health.     Saliva is important in maintaining oral health and comfort. It moistens the mouth, lubricates     food for easier swallowing, provides enzymes needed to begin the digestive process and     promotes repair and cleansing of soft tissues of the mouth. Decreased salivary production or     changes in salivary composition may affect oral and systemic health and cause an increase in     tooth decay.      Patients 4 years of age and older with dry mouth symptoms and a diagnosis of primary,     secondary or incomplete Sj(SqrRoot)(Delta)gren s syndrome or salivary gland dysfunction due     to radiation may be eligible for this study. Candidates will be screened with a complete     medical and dental history and blood and saliva tests. Some patients will have a biopsy of     the minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis     of Sj(SqrRoot)(Delta)gren s syndrome and determine the extent of changes in the salivary     glands. (A biopsy is the surgical removal of a small piece of tissue for laboratory     examination.) The ability to taste and smell may also be evaluated, and patients may have an     ultrasound examination of their swallowing function.      Participants will have a general oral examination of the teeth and soft tissues of the mouth,     general physical examination, eye examination and blood tests and will fill out a     questionnaire on oral health and function. In addition, they will have the following tests     and procedures:        -  Identification of possible fungal infection Patients rinse their mouth with 2 teaspoons          of a salt-water solution and spit it in a sterile container for laboratory examination.          If a fungal infection is detected, treatment will be offered.        -  Unstimulated salivary function assessment Saliva production is measured by collecting          saliva samples through small suction cups connected to collection tubes over the          salivary gland ducts in the mouth.        -  Stimulated salivary function assessment A sour-tasting liquid (2% citric acid) is          applied to the top and sides of the tongue at 30-second intervals to stimulation saliva          production while saliva is collected using the procedure described above.        -  Identification of markers of precancerous lesions The salivary gland biopsy done at the          screening evaluation (or from outside sources) is examined for markers of precancerous          lesions, as about 5 percent of patients with Sj(SqrRoot)(Delta)gren's syndrome develop a          tumor called Non-Hodgkin s lymphoma. In some cases, the minor salivary glands may be          re-biopsied a few years after the screening biopsy.      Patients will be followed once a year with a comprehensive history and physical examination,     eye examination, full oral examination, salivary function assessment and questionnaires about     signs and symptoms of salivary gland dysfunction.   "
176035|NCT00144573|"     This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in     patients with RA with Renal Impairment.   "
162627|NCT00001853|"     It is unknown if obesity contributes to the development of heart disease in African American     men and women.      This study was created to determine whether there is a relationship between sex and body size     and the incidence of heart disease in African American men and women. Researchers will     attempt to associate obesity with the presence of heart disease risk factors. Risk factors     that will be studied include; total body fat, body fat distribution, fat content of the blood     (triglyceride concentration, low density lipoproteins [LDL], and high density lipoproteins     [HDL]), how fast fat is removed from the blood, and how well insulin works in the body.      Scientific studies have shown that obesity and increased levels of fat content in the blood     are important risk factors for heart disease in Caucasian women. However, similar studies in     African American women have failed to show the same correlation. In fact, it appears that     African American women in all three body weight groupings, nonobese, overweight, and obese     experience high death rates due to heart disease. In addition, prior research has shown that     obese African American men tend to have elevated levels of fat in the blood while African     American women have normal blood fat levels. Therefore, if high levels of triglycerides (fat     found in the blood) are not seen in non-diabetic obese African American women, it cannot be     considered a risk factor in this population. This suggests that studies conducted on     Caucasian women may not provide insight into heart disease risk factors in African American     women.      The study will take 120 healthy nondiabetic African American men and women (ages 18-50)     grouped by sex (60 men and 60 women) and body mass index 3 subgroups; nonobese, overweight     and obese). Diabetes undeniably increases the risk of heart disease. Therefore patients     suffering from diabetes will not be included in the study. Candidates for the study will     undergo a series of tests and examinations over 5 outpatient visits. Subjects will have body     fat analyses, resting energy expenditure measurements, an EKG (electrocardiogram), and     specific blood tests.      Researchers believe this study will provide significant insight into the causes of obesity     and heart disease in African Americans.   "
162628|NCT00001854|"     Chronic hepatitis C is a disease of the liver caused by the hepatitis C virus. The disease     can be serious and even fatal. Approximately 25% of patients with chronic hepatitis C will     develop cirrhosis and some of these patients will develop cancer of the liver or liver     failure.      Presently the disease is treated with a combination of alpha interferon or peginterferon     (antiviral and immune stimulating drugs) and ribavirin (an antiviral drug). Alpha interferon     is given by injection three times a week whereas peginterferon is given by injection only     once a week. Ribavirin is given as a tablet by mouth twice a day. The combination therapy is     given for 6 to months. About half of the patients given these medications will receive a     lasting benefit and many patients do not respond well to the combination therapy.      This study will select up to 50 patients will chronic hepatitis C who have not responded to     combination therapy or who could not stand the side effects associated with interferon or     peginterferon therapy. These subjects will be evaluated and undergo liver biopsy to determine     their present liver condition. If selected as subjects they will be started on single drug     therapy with ribavirin. The drug will be given orally twice a day at a dose based on the     patient's body weight.      The patients will be followed on an out-patient basis. They will we asked to return for     regular check-ups and blood tests every 2 to 8 weeks for the duration of the study. After 6     months, the medication will be stopped or adjusted based on the results of the subject's     blood tests (liver enzymes). A response is considered if a decrease of 50% or more of the     initial liver enzyme (alanine aminotransferase, ALT) is noted. A complete response will be     considered if liver enzymes return to normal levels.      Therapy will be discontinued after 6 months if patients do not respond. However, patients     that respond to the single drug therapy will continue to receive the medication at a     decreased dose. The patients will remain on an appropriate dose for up to 8 years with repeat     liver biopsies at 2, 4 and 8 years to assess progress.      This study will determine if long-term therapy with ribavirin is safe and effective.   "
162629|NCT00001856|"     On a yearly basis there are approximately 12,000 kidney transplants in the United States.     Presently there are approximately 40,000 patients awaiting a transplant with only 5,000     available donors. Due to the obvious difference between organ supply and demand, live donors     have become a standard source of kidneys for transplantation.      Research has proven that kidneys from living donors are superior to cadaveric donors (kidneys     harvested from a deceased individual). Kidneys from living donors are not exposed to     extremely low temperature that could increase post-operative problems. They are less likely     to experience rejection and there is a decreased likelihood that a patient will have to     undergo post-operative dialysis.      The objective of this study is to promote the enrollment of healthy individuals to serve as     kidney donors for patients undergoing research kidney transplantation at the NIH. Potential     donors will be screened to make sure they are able to survive with a single kidney without     significant medical risk. Additional tests will be taken to establish compatibility with the     recipient. Compatible donors will be evaluated to determine which kidney is suitable for     transplantation. Both the donation and transplantation procedure will be conducted on the     same day. Appropriate post-operative care and follow-up will be provided at the Clinical     Center.   "
162630|NCT00001857|"     The most common problem following a kidney transplant is the development of acute or chronic     rejection. Rejection is the immunologic reaction in which the body refuses to accept the     transplanted organ. The body's immune system will make destructive antibodies that will     attempt to attack the transplanted organ.      In order to prevent organ rejection, all patients receiving an allograft (a graft     transplanted between genetically non-identical individuals of the same species) must take     anti-rejection therapy. These medications function by lowering the body's natural immune     system. Often these medications are associated with significant side effects ranging from     infections to cancer.      This study is designed to test whether the drug presently known as BG9588 (Antova TM) can     reduce the incidence of organ rejection following kidney transplants in humans. More     specifically, the study will attempt to assess the safety of BG9588 when given alone or when     given in combination with other anti-rejection therapies. Safety will be measured by the     amount of acute or chronic rejections, and immunological graft losses.      Subjects for the study will be made up of non-human primates (monkeys) and humans. Up to 5     subjects in each of the groups receiving kidney transplants will be placed on a 12 month     course of BG9588 with or without additional anti-rejection drugs. BG9588 will be given     intravenously (injected through a vein) prior to the transplant and then in a decreased dose     with a decreased frequency over the year. Following the 12 months of therapy subjects may be     eligible for additional monthly therapy.      The long-term follow up will occur through 30 months after the last dose of BG9588. Subjects     will undergo periodic tests and evaluations throughout the course of the study. These tests     will assess the body's immune system and detect the presence of rejection.   "
162771|NCT00002428|"     To evaluate the safety and immunogenicity of a combination of microparticulate monovalent     HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent     HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in     intermediate or higher risk HIV-negative volunteers.   "
162632|NCT00001859|"     Kidney transplantation is the preferred treatment for most end-stage kidney disease. This     procedure is limited, however, by two major factors: 1) a shortage of donor organs and 2)     organ rejection by the recipient. The National Institute of Diabetes and Digestive and Kidney     Diseases is screening patients with kidney failure or diabetes who may be eligible for     kidney, kidney and pancreas, or islet cell transplantation.      Patients in this screening study are not offered treatment. When the screening is complete,     patients will be offered an opportunity to participate in another institute study, or, if     there are no active studies appropriate for the patient, other options will be suggested to     the primary or referring physician. Patients found eligible for a study are not obligated to     participate.      Screening for all patients typically consists of blood tests, urinalysis, electrocardiogram,     PPD tuberculosis screen and pregnancy test. Chest and kidney X-rays and other studies may be     done on patients determined eligible for a particular study, including transplantation. A     summary of all test results will be sent to the referring physician unless the patient     requests otherwise.   "
162794|NCT00002461|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. Bone     marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of     chemotherapy to kill more cancer cells.      PURPOSE: This phase II trial is studying giving high-dose chemotherapy followed by bone     marrow or peripheral stem cell transplantation to see how well it works in treating patients     with refractory Hodgkin's disease or non-Hodgkin's lymphoma.   "
162634|NCT00001861|"     This screening protocol is designed to help recruitment patients for National Eye Institute     (NEI) studies on nystagmus and strabismus. Patients must meet specific requirements of a     research study, and this protocol serves as a first step for admitting patients to an     appropriate program.      Candidates will undergo a medical history, physical examination, eye examination and blood     test. The eye examination includes measurement of eye pressure and dilation of the pupils to     fully examine the lens, vitreous and retina. Specialized tests will be done only if needed to     determine eligibility for a nystagmus or strabismus study. These include routine laboratory     tests, non-invasive imaging, questionnaires, and other standard tests. If needed, a test     called oculography may be done to record eye movements. There are two procedures for     recording and documenting these movements. In the infrared system, the patient wears a pair     of glasses or goggles and looks at a red light while the head is kept steady. In the search     coil system, the eye is numbed with anesthetic eye drops and a soft contact lens is placed on     the eye. Then the patient looks at a red light while the head is held still. Each oculography     session lasts 20 to 30 minutes. Photographs of the eye may be taken.      When the screening is completed, patients will be informed of their options to participate in     a study. Patients who are ineligible for a current study will be informed of alternative     treatments or options. No treatment is offered under this protocol.   "
162635|NCT00001862|"     This study will investigate the safety and effectiveness of the drug TNFR:Fc to treat uveitis     (eye inflammation) in patients with juvenile rheumatoid arthritis. In other studies, TNFR:Fc     significantly reduced joint pain and swelling in adult patients with rheumatoid arthritis,     and the Food and Drug Administration has approved the drug for that use. Because medicines     for arthritis often help patients with eye inflammation, this study will examine whether     TNFR:Fc can help patients with uveitis.      Patients with uveitis who are not responding well to standard treatment, such as steroids,     and patients who have side effects from other medicines used to treat their uveitis or have     refused treatment because of possible side effects may be eligible for this study. Candidates     will be screened with a medical history, physical examination, and eye examination. The eye     exam includes a check of vision and eye pressure, examination of the back of the eye     (retina), and front of the eye, including measurements of protein and inflammation.     Candidates will also undergo fluorescein angiography-a procedure in which photographs are     taken of the retina to see if there is any leakage in the eye's blood vessels. A blood test     and joint evaluation will also be done.      Study participants will be given a shot of TNFR:Fc twice a week for up to 12 months and may     continue other medicines they may be taking, such as prednisone or methotrexate. They will     have follow-up examinations at week two and months one, two, three and four. Those who wish     to continue treatment after the fourth month can receive the drug for another eight months     and will have follow-up exams at months six, nine and 12, and one month after treatment ends.     Each follow-up visit will include a repeat of the screening exams and an evaluation of side     effects or discomfort from the medicine.   "
162636|NCT00001863|"     This study will investigate the safety and effectiveness of the drug Leflunomide to treat     uveitis-an inflammation of the eye caused by an immune system abnormality. Leflunomide     suppresses immune system activity and has been shown to control autoimmune diseases, such as     arthritis (joint inflammation), in animals. It has also improved symptoms in patients with     rheumatoid arthritis, and the Food and Drug Administration has approved it for treating     patients with this disease. Eye and joint inflammation may have similar causes, and medicines     for arthritis often help patients with eye inflammation. This study will examine whether     Leflunomide can help patients with uveitis.      Patients with uveitis who are not responding well to steroid treatment and patients who have     side effects from other medicines used to treat uveitis (such as cyclosporine,     cyclophosphamide, methotrexate or azathioprine) or have refused treatment because of possible     side effects of these medicines may be eligible for this study. Candidates will be screened     with a medical history, physical examination, blood test and eye examination. The eye exam     includes a check of vision and eye pressure, examination of the back of the eye (retina) with     an ophthalmoscope and the front of the eye with a microscope. They will also undergo a     procedure called fluorescein angiography to look at the blood vessels of the eye. A dye     called sodium fluorescein is injected into the bloodstream through a vein. After the dye     reaches the blood vessels of the eye, photographs are taken of the retina.      Study participants will be divided into two groups. One group will take 100 milligrams of     Leflunomide once a day for 3 days and then 20 milligrams once a day for 6 months. The other     group will take a placebo-a pill that looks like the Leflunomide pill but does not contain     the medicine. All patients in both groups will also take prednisone. Patients will have     follow-up examinations at weeks 1, 4, 8, 12, 16, and 24 (6 months) of the study. Each     follow-up visit will include a repeat of the screening exams and an evaluation of side     effects or discomfort from the medicine. Those who do well and want to continue their     assigned treatment after 6 months can continue that treatment for another 6 months and will     have follow-up exams at months 9 and 12.   "
162637|NCT00001864|"     The purpose of this study is to compare the results of two standard treatments for amblyopia     in order to find out if one is more effective than the other. Amblyopia, which develops in     childhood, is also called lazy eye, because one eye is not being used properly. The brain     favors the other eye for some reason, such as crossing or turning out of the eyes, and vision     in the weak eye is reduced.      Amblyopia is treated by forcing the child to use the weak eye. There are two ways to do this:     1) a patch placed over the good eye forces the child to use the weak eye; or 2) an eye drop     placed in the good eye once a day to blur vision in that eye makes the child rely on the     weak eye. The success rates with both of these methods have been reported to be about the     same; this study will try to identify if one is more effective than the other.      Children will be randomly assigned by computer to one of the following two treatment methods:      Patch      The child initially will wear a patch over the good eye for 8 to 12 hours every day. If     vision in the weak eye improves, the patching time will be decreased. If vision remains good     after 3 months, the patching will be stopped, unless the child's doctor believes treatment     should continue. If vision in the weak eye does not improve, the patching time will be     increased.      Eye Drops      The child will be given one drop per day of atropine in the good eye. If vision in the weak     eye improves, the drops will be given less often. If the vision remains good after 3 months,     the drops will be stopped, unless the child's doctor believes treatment should continue. If     the initial daily drop does not improve the vision in the weak eye, the child's eyeglasses     may be changed to try to further blur the vision in the good eye.      After 6 months, treatment may be stopped if it has not been successful. If treatment has been     successful after 6 months, it may be continued at a reduced amount or stopped.      Follow-up visits will be scheduled every 4 weeks for the first 6 months and every 2 to 4     months after that until the end of the 2-year study. During each visit the eyes will be     examined for eye movements and vision, and the pupils will be dilated to examine the inside     of the eye.   "
162638|NCT00001865|"     This study will evaluate the safety and effectiveness of Zenapax in controlling recurrent eye     inflammations associated with Behcet's disease.      Behcet's disease is usually treated with corticosteroids to suppress inflammation. Other     medicines such as methotrexate, cyclophosphamide, or azathioprine may also be used. These     drugs all can have serious side effects, including liver or kidney damage. Zenapax is a     monoclonal antibody that binds to certain proteins (receptors) on white blood cells,     preventing them from interacting with a chemical called interleukin-2. Blocking this     interaction prevents inflammation.      This study will include 20 patients who had unacceptable side effects from other medicines     used to treat their disease; did not benefit from standard treatment; and refused standard     treatment because of possible side effects of the medicines.      All patients in the study will continue to take their current medicines at the start of the     study. In addition, one group of patients will receive Zenapax and a second group will     receive a placebo. The drug or placebo will be infused into the vein at the start of the     study and every two weeks for the next six weeks, and then every four weeks for the rest of     the study period (24 months). Each infusion lasts about 15 minutes. Patients will have eye     examinations at the time of every treatment, and medicines will be added if needed to control     eye disease. Drugs will be tapered after six months in patients whose eye disease is quiet,     and readjusted as necessary. Neither the doctors nor the patients will know who is receiving     placebo and who is receiving Zenapax until the study ends.      Patients will be given a physical examination, medical history, eye examination, fluorescein     angiography (special photographs of the retina to evaluate the blood vessels in the eye), and     blood tests.      Zenapax was previously studied in 10 patients with uveitis with positive results. The     patients were able to reduce the other medicines they were taking with minimal side effects.   "
162795|NCT00002462|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining radiation therapy with combination chemotherapy may kill     more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no     radiation therapy following chemotherapy in treating patients with stage III or stage IV     Hodgkin's disease.   "
164417|NCT00004843|"     OBJECTIVES: I. Assess the efficacy of surgery vs no surgery in patients with mild     asymptomatic primary hyperparathyroidism.      II. Assess the quality of life, morbidity, and mortality of these patients.   "
162639|NCT00001866|"     This study will examine the safety and effectiveness of a new surgical procedure to correct     congenital nystagmus-a disorder of eye muscle-vision-brain coordination characterized by     rapid to and fro eye movements (oscillation). Nystagmus usually begins in infancy or early     childhood; its effect on vision varies greatly among patients. Current treatments, such as     prism glasses, acupuncture, electronic nerve stimulation, contact lenses, various drug     treatments, and others have had limited success.      Patients with congenital nystagmus sometimes have other eye problems as well, such as     cataracts, glaucoma, astigmatism or strabismus (cross-eyes). When these patients have eye     muscle surgery to correct a problem, such as strabismus, their nystagmus also improves.     Researchers think that simply cutting the muscles might produce this beneficial effect. This     study will test this hypothesis-the horizontal muscles of the eye will be cut and then     reattached in the same position. This procedure has been tried in one sheepdog with good     results.      This small preliminary trial will include five adult patients with congenital nystagmus who     have no other treatment options. It will evaluate the safety of the surgery and its effect on     eye oscillation and vision. If the procedure is found to be safe, additional patients will be     studied.      Patients will have a medical history, basic physical examination, complete eye examination,     and electro-oculography (eye movement recordings) to determine if eligibility for the study.     Those accepted into the study will undergo eye muscle surgery and followup eye examinations     and electro-oculography at 1 week, 6 weeks, 6 months, 1 year, 2 years and 3 years after     surgery.   "
162640|NCT00001867|"     The purpose of this study is to gain information about the course of uveitis (a type of eye     inflammation) during pregnancy and the postpartum period (six months after delivery). Some     reports have indicated the condition may improve or disappear without treatment during     pregnancy and recur postpartum, requiring treatment. No systematic studies have been done,     however, to examine a link between pregnancy and disease suppression.      All medicines for uveitis have side effects-particularly for pregnant women, their unborn     babies, and breast-feeding mothers. The information gained may help guide treatment decisions     for these patients in the future.      Women who are between 2 and 20 weeks pregnant and have had uveitis within 2 years of becoming     pregnant will be followed monthly with an eye examination and blood tests until six months     after giving birth. The eye examination will include dilation of the pupils to look at the     back of the eye. Photos of the eye will be taken to record changes that occur due to uveitis.     The blood tests will assess immune function and try to determine whether levels of hormones     and cytokines are related to uveitis disease activity. Patients who develop an inflammation     and significant vision loss may require treatment, possibly with eye drops or injections near     the eye. Treatment will be decided in consultation with the patient's obstetrician.   "
162641|NCT00001869|"     Pulmonary lymphoangioleiomyomatosis (LAM) is a rare destructive lung disease typically     affecting women of childbearing age. Currently, there is no effective therapy for the disease     and the prognosis is poor.      In order to better study this disease, the National Heart, Lung, and Blood Institute (NHLBI)     has developed a registry to keep an official record of patients diagnosed with LAM. This     research project will collect data from 6 health care centers as well as outside physicians.     Researchers hope to provide valuable information about the rate of lung destruction and     quality of life in patients with LAM.      Patients participating in this study will be followed for 5 years. Tissue collected from     these patients may contribute to the development of future studies on the disease processes     of LAM.   "
162642|NCT00001870|"     Diabetes is a disease characterized by decreased sensitivity to the action on insulin to     promote sugar (glucose) use and blood vessel relaxation (vasodilation) in muscle. Insulin's     ability to cause blood vessel relaxation is controlled, in part, by nitric oxide (NO).      Nitric oxide is a substance produced by the cells lining blood vessel walls (endothelium).     Increased blood flow to the muscle accounts for increased sugar (glucose) to areas of the     body. Therefore, if the cells of blood vessel walls (endothelium) are not functioning     properly it may contribute to insulin resistance.      Injections of Vitamin C directly into the arteries have been shown to improve blood vessel     reaction to nitric oxide in diabetic patients. Researchers believe this may be due to Vitamin     C's ability to increase the levels of nitric oxide in blood vessels.      The goal of this study is to determine the effects of vitamin C on both insulin sensitivity     and endothelium function of patients with type 2 diabetes. An additional goal of the study is     to determine the effects of vitamin C on patients with vitamin C deficiency.      Patients participating in this study will undergo a series of testes to determine insulin     sensitivity and blood vessel reactivity. Patients will be divided into two groups. One group     will receive doses of oral vitamin C. The other group will receive doses of a placebo     (inactive pill not containing vitamin C). Patients will receive the medications for four     weeks and then be tested again for insulin sensitivity and blood vessel reactivity.      Researchers believe that doses of vitamin C in diabetics or patients with vitamin C     deficiency will improve insulin sensitivity and function of endothelium. Results gathered     form this study may provide information about vitamin C levels in diabetics and may lead to     the development of new therapies to treat insulin resistance and endothelium dysfunction.   "
162671|NCT00001906|"     While vaccination against cutaneous leishmaniasis, a chronic ulcerating protozoan infection     of the skin, has been possible for decades using live parasites, the production and storage     of live cultures are difficult. Since inoculation occasionally leads to severe infection,     most experts now advocate against their use. We have shown excellent protection using a     heat-killed vaccine that combines autoclaved leishmania antigen with recombinant human     interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants in a rhesus macaque model of     disease. To assess the safety and immunogenicity of this vaccine in humans, we now propose a     rhIL-12 dose escalation Phase I/II trial.   "
162772|NCT00002429|"     This study tests a new form of didanosine, ddI EC, a coated pill that passes through the     stomach before dissolving. The purpose of this study is to compare the effectiveness of an     anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.   "
162656|NCT00001886|"     An echocardiogram is an ultrasound technique used to gather information about the heart.     Standard echocardiograms create images of the heart in two dimensions, thereby named 2D     (two-dimensional) echocardiography. A new technique has been developed allowing images to be     taken of the heart in three dimensions (real time 3D echocardiography).      The 3D echocardiogram uses high frequency sound waves to see and record the movement and     function of the heart muscle. The echocardiogram is taken by placing an instrument called a     transducer against the chest wall over the heart.      In this study patients will undergo a dobutamine stress echocardiogram. Dobutamine is drug     that causes the heart to beat stronger and faster, similar to how it acts when exercising.     Dobutamine allows researchers to tell if the heart is suffering from a lack of oxygen during     exercise or other forms of stress, or if it is permanently damaged.      The purpose of this study is to determine whether stress 3D echocardiography is feasible and     accurate in the detection of heart disease (coronary artery disease). Results of the 3D     echocardiogram will be compared to results from standard 2D echocardiograms.   "
162643|NCT00001871|"     Hypertrophic cardiomyopathy (HCM) is a genetically inherited disease affecting the heart. It     causes thickening of heart muscle, especially the chamber responsible for pumping blood out     of the heart, the left ventricle. This condition can cause patients to experience symptoms of     chest pain, shortness of breath, fatigue, and heart beat palpitations. Researchers believe     the disease may be caused by abnormalities in the genes responsible for producing proteins of     the heart muscle.      Oculopharyngeal muscular dystrophy (OPMD) is another genetically inherited disease. This     condition affects the muscles of the eyes and throat causing symptoms of weak eye movements,     difficulty swallowing and speaking, and weakness of the arms and legs.      In previous studies researchers have found that several patients with hypertrophic     cardiomyopathy (HCM) also had oculopharyngeal muscular dystrophy (OPMD). Researchers are     interested in learning more about how these two diseases are associated with each other.      In this study, researcher plan to collect samples of muscles (skeletal muscle biopsies) from     patients belonging to families in which several members have inherited one or both of these     diseases. The muscle samples will be used to link the muscle abnormalities with the specific     genetic mutations.      Patients participating in this study may not be directly benefited by it. However,     information gathered because of this study may be used to develop better techniques for     diagnosing and treating these conditions.   "
162644|NCT00001872|"     Blood contains different kinds of cells, white blood cells, red blood cells, and platelets.     In order to treat certain diseases, specific cell types can be removed from blood and     transplanted into patients. The process of removing white blood cells for the treatment of     leukemia is called apheresis.      This study will make available blood cell collections from volunteers genetically matched to     various degrees with recipients in order to test and, if necessary, refine the process of     removing white blood cell T-lymphocytes.   "
162645|NCT00001873|"     Cancers of the blood, sometimes referred to as hematologic malignancies, are disorders of     bone marrow cells that lead to the failure of the normal function of bone marrow and the     uncontrolled growth of cancerous cells in the bone marrow. These cancerous cells can spill     over into the bloodstream and affect other organs causing widespread symptoms. The disease is     life threatening because it blocks the normal function of the marrow, which is to produce red     cells (preventing anemia), white cells (preventing infection), and platelets (preventing     progression).      Bone marrow transplants are a potential form of therapy for patients with hematologic     malignancies. However, BMT is a complicated procedure and can be associated with dangerous     side effects.      In this study researchers are attempting to find ways to reduce the complications of BMT, so     that it would be possible to use it more safely and can be offered more patients. In order to     do this, researchers are developing new techniques to make BMT safer. It requires making     small changes to the standard procedure, which may improve the outcome.      The experimental procedures researchers are evaluating are:        1. <TAB>T-cell depleted peripheral blood progenitor cell (PBPC) transplantation        2. <TAB> Cyclosporine given immediately after the transplant        3. <TAB>Add-back of donor lymphocytes      Patients undergoing these experimental techniques must be monitored closely to see if any     benefit or harmful effects will occur. Information gathered from this study can be used to     develop further research studies and potential new therapies for hematologic malignancies.   "
162646|NCT00001874|"     Magnetic resonance imaging (MRI) and spectroscopy are diagnostic tools that create high     quality images of the human body without the use of X-ray (radiation). MRI uses different     levels of magnetic fields to create images of the body and organs. Occasionally, researchers     will give patients undergoing a MRI an injection of a contrast substance. The contrast     substance works by brightening areas of the magnetic resonance image.      In this study researchers plan to use magnetic resonance imaging with contrast substances and     exercise on normal volunteers in order to evaluate different aspects of its performance.     Information gathered from this study may be used to develop more specific research studies     involving MRI....   "
162647|NCT00001876|"     Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and     fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid     arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.      Patients participating in this study will undergo a series of tests and examinations before     and throughout the study. The tests include blood and urine tests, electrical measures of     heart function (ECG), chest x-rays, CAT scans, nuclear medicine scans, breathing tests,     exercise tests, and fiberoptic bronchoscopy.      The goals of this study are to:        1. Estimate how common pulmonary fibrosis is in patients with rheumatoid arthritis,        2. Describe the natural course of pulmonary fibrosis in patients with rheumatoid arthritis,        3. Estimate the survival rate of patients with pulmonary fibrosis and rheumatoid arthritis,          and        4. Learn more about the factors that contribute to the development or progression fibrotic          lung disease.   "
162648|NCT00001877|"     Sarcoidosis is a disease most commonly affecting the lungs, but it can also involve lymph     nodes, skin, liver, spleen, eyes, bones, and glands. The cause of the disease is unknown.     When it occurs it can produce an inflammatory reaction leading to irreversible organ damage     and disability.      In sarcoidosis granulomas can form in various organs (primarily lung) which can lead to its     dysfunction. Granuloma is formed by clusters of inflammatory cells. The formation of these     granulomas is influenced by the release of a substance called TNF-alpha (tumor necrosis     factor alpha) which is found in some white blood cells. A drug known as pentoxifylline (POF)     is known to markedly reduce the release of TNF-alpha.      The standard medical treatment for sarcoidosis is steroid therapy. However, steroid therapy     is associated with significant side effects and often must be stopped. Unfortunately, some of     these patients can relapse when the steroid therapy is discontinued. Because of this,     researchers are interested in finding alternative therapies for the treatment of sarcoidosis.      This study will evaluate the effectiveness of giving POF to patients with sarcoidosis     currently taking steroids. Researchers will compare the results between patients taking     steroids with pentoxifylline and those patients taking steroids alone.   "
162773|NCT00002430|"     The purpose of this study is to compare two different anti-HIV drug combinations, one that     contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV)     also will be studied.   "
165904|NCT00005720|"     To develop a scientifically valid and ethnically approved, lay-led smoking cessation     intervention for Southeast Asian men and women, i-e., those from Cambodia, Laos, and Vietnam.   "
162649|NCT00001878|"     The human heart is divided into four chambers. One of the four chambers, the left ventricle,     is the chamber mainly responsible for pumping blood out of the heart into the circulation.     There is an inherited condition affecting the heart, passed on through genetics, hypertrophic     cardiomyopathy (HCM). HCM causes the left ventricle to become abnormally enlarged (left     ventricular hypertrophy LVH).      Some patients with the abnormal genes that may cause HCM do not have the characteristic LVH.     Approximately 20 - 40% of patients with the genetic abnormality (missense mutation of genes     encoding for sarcomeric protein) actually have an enlarged left ventricle. Because of this,     researchers believe there may be other factors, along with the genetic abnormality that     contribute to the development of HCM. Researchers are interested in learning more about     several factors they suspect may play a role in the development of HCM.      Specifically, researchers plan to study levels of a hormone and the protein it attaches to,     which may contribute to the development of an abnormally enlarged heart. Insulin-like growth     factor (IGF-1) and insulin-like growth factor binding protein (IGFBP) work together with     growth hormone (GH) in the development and maturation of many organ systems. Previous studies     have suggested that these hormones affect the development and function of the heart.      Patients participating in this study will undergo a variety of tests including collection of     blood samples, echocardiogram of the heart, treadmill exercise test, and continuous     electrical monitoring of heart activity (Holter monitor).   "
162650|NCT00001879|"     Hepatitis is an inflammation of the liver. Hepatitis can be caused by an infection with a     virus, but poisonous (toxic) substances can also cause it. Researchers have identified     several of the viruses responsible for hepatitis, however some patients with hepatitis show     no evidence of being infected with known hepatitis viruses. Researchers call conditions like     this, seronegative hepatitis. It means that a patient has hepatitis but he/she does not have     evidence in their blood of a viral infection.      Seronegative hepatitis is often complicated by autoimmune disorders and associated severe     disorders especially, fulminant hepatitis of childhood and post-hepatitis aplastic anemia.      Researchers have attempted to identify the cause of these conditions but have been     unsuccessful. Therefore, this study was developed to collect blood and stool samples from     patients with seronegative hepatitis in order to help identify the virus responsible.   "
162651|NCT00001880|"     The goal of this research study is to identify other types of cancer (malignant neoplasms)     that may be treatable with stem cell transplantation (allogenic peripheral blood stem cell     transplantation.      Patients with a variety of different types of cancerous tumors that have spread     (metastasized) and whose conditions have not improved with stand therapy, will be eligible to     participate. Those patients selected to participate in the study will undergo a procedure     known as a mini-transplant. The mini-transplant is a transplantation of stem-cells     collected from a sibling (brother or sister) of the patient. Unlike traditional bone marrow     transplants, the mini-transplant does not require intense chemotherapy or radiation therapy.     Because of this, patients experience fewer and less severe side effects.      This study is open to patients diagnosed with a variety of metastatic solid tumors including     esophageal, gastric (stomach), colon, rectal, liver tumors (hepatoma), cancer of the biliary     system (cholangiocarcinoma), cancer of the pancreas, lung, breast, prostate, bone (sarcoma),     adrenal basal cell, bladder, and adenocarcinomas of unk primary origin....   "
162652|NCT00001881|"     Genetically inherited heart diseases (familial cardiomyopathies) are conditions affecting the     heart passed on to family members through abnormalities in genetic information. These     conditions are responsible for many heart related deaths and illnesses.      In this study researchers hope to determine the signs and symptoms (clinical correlation)     associated with specific genetic abnormalities causing inherited heart diseases.      In order to do this, researchers plan to evaluate patients and family members of patients     diagnosed with inherited heart disease. Patients participating in the study will undergo     several tests including blood tests, electrocardiograms (EKG), and echocardiograms. Patients     may also be asked to undergo an MRI of the heart to provide a clearer picture of it.      Patients participating in this study may not be directly benefited by it. However,     information gathered from the study may contribute to the medical care, treatment, and     prevention of problems for others in the future.   "
162653|NCT00001883|"     This study is designed to make sure exercise equipment used by the National Heart, Lung, and     Blood Institute is working properly. Healthy volunteers will be requested to use P-CCMB     cardiopulmonary exercise equipment (treadmills and exercise bicycles) two times a month to     ensure the machines are functioning properly.   "
162654|NCT00001884|"     Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and     fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid     arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.      Researchers hope to improve their understanding of the disease process involved in PF and RA     by analyzing specimens collected by bronchoscopy, lung biopsy, lung transplantation, or     autopsy from patients with these conditions.      The purpose of this study is to collect specimens from rheumatoid arthritis patients with and     without pulmonary fibrosis as well as patients with pulmonary fibrosis without associated     diseases or cause (idiopathic pulmonary fibrosis).   "
162655|NCT00001885|"     Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and     fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid     arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.      Data gathered from previous research studies suggest that genetics may play a role in the     development of PF in patients with rheumatoid arthritis. However, the actual genetic factors     involved in the disease process have not been identified.      The goal of this study is to identify the genetic markers in patients with pulmonary fibrosis     and rheumatoid arthritis.   "
162774|NCT00002431|"     To evaluate the safety and effectiveness of Peridex (an oral rinse containing chlorhexidine     gluconate) for preventing the occurrence of clinically-evident microbiologically-documented     oral candidiasis in HIV-positive patients, who are at risk of the disease based on previous     history of candidiasis.   "
162775|NCT00002432|"     To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS     patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the     safety and efficacy of foscarnet maintenance therapy for treatment of AIDS patients     experiencing CMV retinitis.   "
162657|NCT00001887|"     Asthma is the third leading cause of preventable admissions to the hospital in the United     States. Deaths and diseases associated with asthma increase every year. Asthma is a disorder     of airway inflammation. There are several factors thought to play a role in the process of     inflammation.      In this study researchers are particularly interested in studying a factors known as TNF     (tumor necrosis factor) and the sites where this factor attaches called receptors. Another     factor associated with receptor processing is called aminopeptidase-like protein. It may be     involved in the relationship between TNF, it's receptors, and inflammation.      In order to understand the relationship between these factors, researchers plan to simulate     an allergic reaction in the lungs and airways of patients participating in the study. By     doing this they can collect and study the factors causing airway inflammation. Samples     collected from patients with asthma will be compared to samples from volunteers without     asthma.      Patients and volunteers participating in this study will not directly benefit from this     research. However, the study may help researchers understand the causes and processes     involved in asthma. In addition, the study may lead to the development of new treatments for     asthma and airway inflammation.   "
162658|NCT00001888|"     Fiberoptic bronchoscopy is a procedure which involves passing a pencil-thin tube into the     lung in order to collect fluid and cells from the airways. Fiberoptic bronchoscopy can     collect cells from the walls of airways by gently brushing them (bronchial brushing). In     addition, squirting small amounts of sterile water in to the airway and gently suctioning it     back into the bronchoscope (bronchoalveolar lavage) collects cells.      In this study, researchers plan to perform these tests on patients with asthma and normal     volunteers. This research may help to improve the understanding of the processes involved in     airway inflammation and asthma.   "
162659|NCT00001889|"     This study is designed to compare two different echocardiographic techniques in the     evaluation of heart disease (coronary artery disease). Both tests called Myocardial Contrast     Echocardiography with Pharmacologic Stress and Stress Echocardiography with Dobutamine, are     performed using a standard echocardiographic machine.      Myocardial Contrast Echocardiography (MCE) does not use radioactivity. It uses sound waves     like standard echocardiography. However, with MCE patients receive an injection of a     contrast agent directly into the blood stream through a vein. The contrast agent, called     Optison, is made of tiny microbubbles smaller than red blood cells. The echocardiogram can     detect these microbubbles in the small blood vessels of the heart muscle and allow     researchers to find areas of the heart receiving less blood flow than others. It is important     to observe the heart during exercise because there are changes in blood flow. Since MCE     cannot be performed when the patient is exercising, researchers give medication (adenosine)     that stimulates the heart and creates a situation similar to exercise.      Stress Echocardiography with Dobutamine does not use radioactivity. It uses sound waves like     standard echocardiography. During this echocardiogram patients receive doses of a medication     called dobutamine that stimulates the heart to beat stronger and faster.      The purpose of this study is to evaluate the accuracy of MCE compared to stress     echocardiography at detecting coronary artery disease (CAD).   "
162660|NCT00001890|"     Hardening of the arteries (atherosclerosis) and heart disease are much more common in men     than in women. However, as women grow older, especially after menopause the incidence of     atherosclerosis and heart disease increases. These findings suggest that estrogen may be     protective and help in preventing heart disease.      Studies of large groups of post-menopausal women suggest that hormone replacement therapy     (therapy that includes estrogen) reduces the risk of heart disease. Estrogen causes favorable     changes in particles that carry cholesterol in the blood stream and improves function of     blood vessels. Estrogen may also stimulate the immune system's ability to fight off     infections that may lead to or contribute to atherosclerosis.      Researchers believe two specific infectious agents (Chlamydia pneumoniae and human     cytomegalovirus) may cause damage to the lining of blood vessels resulting in inflammation     and the development of atherosclerosis.      The purpose of this study is to determine if estrogen treatment can change how the immune     system responds to chronic infections, by Chlamydia pneumoniae and human cytomegalovirus, in     postmenopausal women.   "
162672|NCT00001908|"     Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow     obstruction. Fourteen million people (6.4%) in the United States report having asthma, and     from 1980 to 1994 the prevalence of self-reported asthma in the United States increased 75%.     Interleukin-4 (IL-4) plays a key role in this response by promoting IgE production,     upregulating IgE receptors, upregulating adhesion receptors such as VCAM-1, promoting Th2     cell development and promoting mucus secretion. A soluble form of the receptor for IL-4     (IL-4R) that has antagonist activity has been developed for clinical use. Soluble IL-4R acts     by competing with endogenous cell bound IL-4R for free IL-4, thus inhibiting IL-4 function.     IL-4 is required for the development of allergen specific Th2 memory cells. Less well     understood are the factors required for maintenance of Th2 responses. The maintenance of     polarized Th2 responses to allergens have been postulated to require IL-4 itself, by acting     as an anti-apoptotic/survival factor or by differentiating naive allergen specific T cells to     the Th2 phenotype. Subjects on sIL-4 therapy represent a unique patient group that possess     allergen specific Th2 cells, but in which the capacity for IL-4 to promote further Th2 cell     survival or differentiation has been blocked. This is a single site adjunct study proposed to     study subjects ages 14 years and older who are enrolled at the NIH Clinical Center on a     multicenter trial of IL-4R in moderate to severe asthma (Phase II Efficacy Study of     Aerosolized Recombinant Human IL-4 Receptor in Asthma). A maximum of 40 subjects will be     enrolled. We hypothesize that effective blocking of such Th2 priming would result in a     decreased frequency of both allergen specific Th2 cells as well as mitogen activated Th2     cells. Determination of the fate of Th2 cell responses during long term IL-4R therapy may     have important implications both for future development of anti-cytokine therapies as well as     for understanding the T cell biology of allergic diseases and asthma.   "
162689|NCT00001927|"     Effective treatment and prevention strategies for childhood stroke and porencephaly can only     be developed once the causes are understood. There is increasing evidence that inherited and     acquired coagulation abnormalities alone or in combination with environmental factors,     predispose to arterial and venous thrombosis. Inherited abnormalities of factor V Leiden,     prothrombin, protein C, protein S, and antithrombin III may account for many of these     thromboses. At present there is little information on the existing distribution of these     coagulation anomalies in children with thrombosis. Recent reports also suggest that these     clotting abnormalities may be responsible for some instances of intracranial hemorrhage,     porencephaly, cerebral palsy and fetal death.      This study will measure the frequency of several coagulation factor abnormalities (factor V     Leiden, prothrombin 20210A, protein C, protein S, antithrombin III, and antiphospholipid     antibodies) in children with a history of porencephaly and stroke, and will compare these to     the prevalence of these mutations in population controls and family members. We will also     describe the exogenous conditions which in concert with these coagulation factors, may have     led to the development of thrombosis in these children....   "
162661|NCT00001891|"     Coronary artery disease (CAD) can cause poor blood flow and supply to the heart muscle. It     can result in irreversible damage to the heart muscle and poor function. Before treating     patients with heart disease it is important to know how well the heart is functioning.     Echocardiography is a diagnostic test that can measure heart function. If part of the heart     muscle is not working properly due to previous damage, echocardiography can provide     information about how much improvement can be expected after treatment (surgery or     angioplasty).      The purpose of this study is to compare the accuracy of myocardial contrast echocardiography     (MCE) to dobutamine echocardiography to detect the potential for damaged heart muscle to be     treated and function in patients with heart disease.      Myocardial contrast echocardiography (MCE) does not use radioactivity. It uses sound waves     like standard echocardiography. However, with MCE patients receive an injection of a     contrast agent directly into the blood stream through a vein. The contrast agent, called     Optison, is made of tiny microbubbles smaller than red blood cells. The echocardiogram can     detect these microbubbles in the small blood vessels of the heart muscle and allow     researchers to find areas of the heart receiving less blood flow than others.      Echocardiography with Dobutamine does not use radioactivity. It uses sound waves, like     standard echocardiography. During this echocardiogram patients receive doses of a medication     called dobutamine that stimulates the heart to beat stronger and faster. Heart muscle that     does not beat stronger after dobutamine is probably dead, usually as a result of a previous     heart attack.   "
162662|NCT00001893|"     The proposed study is a phase II clinical trial of TNFR:Fc therapy in a segmental allergen     bronchoprovocation model of atopic asthma. The goal of this study is to assess whether     inhibition of tumor necrosis factor (TNF) bioactivity can attenuate airway inflammation in     mild-to-moderate allergic asthmatics. This protocol will utilize a randomized, double-blind,     placebo-controlled trial design. TNF bioactivity will be inhibited via systemic     administration (e.g., subcutaneous injection) of a dimeric fusion protein consisting of the     extracellular ligand binding domain of the 75-kilodalton TNF receptor linked to the Fc     portion of human IgG1 (TNFR:Fc, Immunex). The data generated by this study will address the     utility of anti-TNF therapy for patients with asthma.   "
162663|NCT00001894|"     This study will compare two treatments: pacemaker implantation and percutaneous transluminal     septal ablation (PTSA) for patients with hypertrophic cardiomyopathy (HCM), a condition in     which the heart muscle thickens and obstructs the flow of blood out of the heart. The reduced     blood flow can cause chest pain, shortness of breath, palpitations, tiredness,     lightheadedness and fainting.      Patients with HCM who cannot be helped by drug therapy may participate in the study. The     standard treatment for such patients is septal myectomy, an operation in which the surgeon     shaves the muscle obstructing the blood flow. Another treatment option is implantation of a     type of pacemaker that causes the heart to contract in a certain way that reduces blood flow     obstruction and improves symptoms. The pacemaker is implanted under local anesthesia and     usually takes less than an hour. PTSA is an experimental treatment that may provide a third     option. In PTSA, a thin tube (catheter) is inserted into the blood vessel that feeds the     heart muscle causing the blood flow obstruction. A small amount of alcohol is injected     through the catheter to destroy some of the muscle and relieve the obstruction.      Candidates will have the following screening tests: chest X-ray, electrocardiogram,     echocardiogram, exercise tests, exercise radionuclide angiography, exercise thallium     scintigraphy, Holter monitoring, cardiac catheterization, electrophysiology study, and     coronary angiography. Participants will be assigned to one of the two treatments groups:     pacemaker implantation or PTSA. Patients in the PTSA group will also have magnetic resonance     imaging scans at the start of the study, 3 to 7 days after PTSA, and at the end of the study,     in order to observe changes in the heart's shape. All patients will fill out a questionnaire     answering questions about their quality of life.      Patients' progress will be followed with monthly phone calls. In addition, various tests,     such as exercise tests and echocardiography, will be done during repeat visits at three and     six months to measure treatment results. Patients will again complete quality-of-life     questionnaires at both of those visits.   "
162664|NCT00001895|"     Patients with narrowed heart arteries who undergo coronary angiography (imaging of the     heart's blood vessels) may participate in this heart mapping study designed to gain     information about the condition of different areas of the heart muscle.      In coronary angiography, a thin tube called a catheter is inserted through a small incision     in the groin and pushed up to the heart. There, a contrast dye is injected, revealing areas     of blockage in the coronary arteries-the vessels that supply blood to the heart muscle. As     soon as the angiography is completed, patients in this study will undergo another procedure     called Biosense mapping. For this procedure, a special catheter with a tiny sensor at the     tip will be inserted into the sheath that was used for the angiography and advanced to the     heart's main pumping chamber-the left ventricle. The sensor detects the pattern of an     electromagnetic field generated from a pad under the patient, and an image of the precise     location of the catheter in 3-dimensional space can be seen on a computer screen. The     catheter is then navigated to various precise locations in the ventricle, producing an     electromechanical map that distinguishes scarred muscle tissue from healthy     tissue-information that can be important in guiding treatment.      When this mapping is completed, the patient will be given a drug called dobutamine to     increase the heartbeat, and the mapping will be repeated. The heart may also be mapped while     the heart rate is increased with a pacing catheter to simulate exercise. The test will be     stopped if adverse side effects develop.      Patients in the study will also have magnetic resonance imaging (MRI) and PET (positron     emission tomography) scans to get additional information about the heart muscle, such as     blood flow and metabolism rate.   "
162665|NCT00001898|"     This study will look at genetic changes which occur in the development of male and female     breast cancer and other cancer. It will use a new technology called DNA microarray     hybridization that looks at a wide array of genes to identify disease-associated patterns in     the human genome (complete set of human genes). Numerous studies have linked particular genes     to a given disease, but there is very little information on patterns of gene expression     (production of proteins from genetic coding) in the entire human genome.      Pinpointing genetic abnormalities in disease may help classify different forms of cancer and     perhaps lead to new avenues of treatment or prevention. A primary goal of this study will be     to create a database of gene expression for human cancers and other disorders that will     provide the basis for finding genetic abnormalities in disease.      Tumors specimens used in this study will be taken from tissues biopsied from patients with     breast, colon cancer, sarcomas or melanoma as part of their routine care. Patients in the     study will be among those receiving care at the: Department of Oncology, University Hospital,     University of Lund, Sweden (breast cancer); Department of Medicine, University of Michigan,     Ann Arbor, Michigan (breast cancer); Surgery Branch, National Cancer Institute, Bethesda,     Maryland (melanoma), Johns Hopkins Univ. (colon cancer), Memorial Sloan Kettering (sarcoma).      Patients in the study will have a family history taken and will complete a questionnaire.     Some patients will be asked to have a blood test. Breast cancer patients will have a     mammogram if one has not been done within the last year.   "
162666|NCT00001899|"     This study will examine the effects of increases in HIV blood levels on the immune system. A     better understanding of how HIV alters the immune response may lead to development of     effective immune-based therapies against the virus.      Patients 18 years of age or older with HIV-1 infection who have been receiving highly active     antiretroviral therapy (HAART) may be eligible for this study. In order to study the effect     of increased levels of virus on the immune system, therapy will be stopped in these patients     temporarily. Therefore, only patients who have an appropriate level of understanding of the     potential benefits of therapy and the risks of stopping treatment will be considered for     enrollment. Pregnant women may not participate and women of childbearing potential must agree     not to become pregnant during the study. Candidates will be screened with a medical history,     physical exam, blood and urine tests and possibly a chest X-ray and electrocardiogram.      Upon entering the study, participants will have blood tests to measure the amount of virus in     the blood, CD4+ T cell counts, side effects of the medications, and how the patient s immune     system responds to HIV in the test tube. White cells will be collected through leukapheresis.     In this procedure, a needle is placed in an arm vein and blood flows from the vein through a     tube (catheter) into a cell separator machine, where the white cells are separated from the     rest of the blood by a spinning process. Some of the white cells are collected by the     machine, and the rest of the blood is returned to the body through a second needle placed in     the other arm. Patients will then have a physical examination and blood tests every 1 to 2     weeks and will be managed according to their viral load and CD4 cell counts as follows:      Viral Load        -  If viral blood levels remain less than 5000 copies per milliliter, no medical          intervention is planned.        -  If viral blood levels rise to 5,000 copies per ml or higher, patients will undergo a          second leukapheresis and re-start antiretroviral therapy. They will be monitored at          least monthly until viral load returns to pre-study levels.      CD4 Count        -  If the CD4 count rises or remains at pre-study levels, no intervention is planned.        -  If the CD4 count decreases by 10 to 25 percent of pre-study levels, the counts will be          monitored every 2 weeks at least 3 times and then monthly.        -  If the CD4 count decreases by 25 percent or more of pre-study values, antiretroviral          therapy will be re-started and counts will be monitored until they return to pre-study          levels.      If viral and CD4 levels do not return to pre-study levels promptly, patients will continue to     be monitored and will be advised about possible treatment changes. Alternatively, patients     whose viral and CD4 levels are similar to or better than pre-study values may be offered     laboratory testing every 3 months for at least 1 year if there is a scientific reason to     continue studying the patient s immune system. Patients may be asked to undergo additional     leukapheresis in the future, or another interruption of therapy in the future if it is felt     safe to do so.   "
162667|NCT00001901|"     This study will examine the use of etanercept (also called Enbrel or TNFR:Fc) in patients     with Wegener's granulomatosis, a type of vasculitis (blood vessel inflammation). Wegener's     granulomatosis may affect many parts of the body, including the brain, nerves, eyes, sinuses,     lungs, kidneys, intestinal tract, skin, joints, heart, and other sites. Generally, the     greater the disease involvement, the more life-threatening it is. Standard treatment is a     combination of prednisone and a cytotoxic agent-usually cyclophosphamide or methotrexate.     However, many patients treated with this regimen have a disease relapse, and others cannot     take these drugs because of severe side effects. This study will evaluate etanercept's safety     and effectiveness, and particularly its value in reducing the need for prednisone and     preventing disease relapse.      The Food and Drug Administration has approved etanercept for treating rheumatoid arthritis,     another inflammatory disease. The drug works by blocking the activity of TNF-a protein made     by white blood cells that is involved in the inflammatory process. Since prednisone also     affects inflammatory proteins and lowers TNF production, the use of etanercept may reduce the     need for prednisone in patients with Wegener's granulomatosis, and thus the risk of its side     effects.      Patients between 10 and 70 years of age with Wegener's granulomatosis who have never taken     prednisone, methotrexate or cyclophosphamide, or have taken these drugs for less than 3 weeks     may be eligible for this study.      Participants will have a medical history review and physical examination, including     laboratory studies. If medically indicated, X-rays, consultations and biopsies (surgical     removal of a small tissue sample) of affected organs will also be done. All patients will     begin treatment with prednisone, methotrexate and etanercept. Those who improve on this     regimen will stop prednisone gradually over 3 months. Those who achieve disease remission at     the end of another 3 months will be randomly assigned to either continue taking etanercept     and methotrexate for another 12 months or to stop etanercept and continue only methotrexate     for the next 12 months (after which methotrexate will gradually be stopped). Patients who are     not in remission by the 6-month point will continue taking etanercept until they go into     remission, when they will be assigned to stop or not stop etanercept, as described above.     Patients who do not achieve remission within 12 months of beginning treatment will be taken     off the study. Patients who have a disease relapse while on the study will likely be switched     to treatment with prednisone and either methotrexate or cyclophosphamide. Patients randomized     to stop etanercept and who have a relapse within a year of stopping the drug may be offered     re-treatment on this protocol, but with continuing etanercept for a full year after     remission.      Patients will be evaluated in the outpatient clinic every 2 to 4 weeks for the first 4 months     and every 1 to 3 months after that. Patients whose disease is in remission and who stop all     medications will be followed every 3 to 6 months for 2 years. Follow-up evaluations include a     physical examination, blood draws and, if medically indicated, X-rays. The total study     duration is 60 to 70 months.   "
162668|NCT00001903|"     Respiratory Syncytial Virus (RSV) infections are very common and widespread. By age 5,     virtually everyone has been infected and developed antibodies against some strain of the     virus. RSV infections happen during adulthood, leading to common cold syndromes. In Bone     Marrow Transplant recipients the disease is much more severe, usually progressing to     pneumonia. This phenomenon is associated with mortality rates around 60-80%.      RSV Polyclonal Immunoglobulin (Respigam® (Registered Trademark)) has been approved by the     Food and Drug Administration and recommended by the American Academy of Pediatrics for     prophylaxis of RSV disease in premature babies and children born with bronchopulmonary     dysplasia. Furthermore, it has been used to treat RSV pneumonia in children and Bone Marrow     Transplant recipients with encouraging results and no complications.      Currently, no preventive strategies are available when approaching this infection among bone     marrow transplant patients. We intend to prevent our bone marrow transplant patients from     developing RSV pneumonia by employing the strategy already used in premature babies, i.e., by     passive immunization with Respigam® (Registered Trademark). Our goal to evaluate the efficacy     and safety of this strategy in such immunocompromised population.      We believe that this will be a more reasonable approach than waiting for the infection to     settle in and only then treating it, because optimal therapy is not currently available.   "
162669|NCT00001904|"     This minimal risk protocol is designed to assess the reproducibility of B-mode ultrasound     measurements of carotid intima media thickness (IMT) when the scans are performed in CC     Radiology and read using a computerized edge reader. Up to 20 volunteers will have two     ultrasounds performed within a 6-month period. IMT thickness is used as a surrogate marker     for atherosclerosis and may be of value in clinical trials.   "
162670|NCT00001905|"     This study will evaluate the safety and effectiveness of the drug, interferon gamma, in     treating leukocyte adhesion deficiency type I (LAD I). Patients with this inherited immune     disorder do not have enough proteins called adhesion molecules on their infection-fighting     white blood cells, impairing the ability of these cells to get to the site of infection. As a     result, patients have recurrent infections of soft tissues, such as the skin, gums and     gastrointestinal tract, and poor wound healing. Infants with severe LAD I often die from     multiple infections. Interferon gamma may increase the number of adhesion molecules on white     blood cells, and thus improve their function.      Patients with LAD I who weigh more than 13 kilograms (28.5 pounds) may be eligible for this     study. Candidates will have personal and family medical histories taken, a physical     examination, blood and urine tests and a chest X-ray or computed tomography (CT) scan.      Participants will receive injections of interferon gamma under the skin 3 times a week for 3     months. Adult patients will be taught how to give their own injections (similar to insulin     injections for diabetes) and parents will be taught how to administer the shots to their     child. Blood samples, usually be between 30 to 90 milliliters (2 to 6 tablespoons), will be     drawn just before starting medication and again 1 day, 1 week, 1 month, 3 months and 4 months     after therapy begins. At these same time intervals, patients will provide a salt-water mouth     rinse specimen, which will be tested for changes in the number of white blood cells during     interferon gamma treatment.      Patients will be admitted to the NIH Clinical Center for inpatient evaluations at the start     of therapy and again after 1 week, 1month, 3 months and 4 months. The initial screening visit     will take a few days and subsequent visits will take 1 to 2 days.   "
162776|NCT00002433|"     To determine safety and tolerance of administering aerosolized recombinant interferon gamma     (IFN-gamma) for 4 weeks in patients with AIDS. To examine activation of alveolar macrophages     by aerosolized IFN-gamma administration. To determine if subcutaneous (SC) injection of     IFN-gamma can activate alveolar macrophages in AIDS patients.   "
165905|NCT00005721|"     To retain individuals as blood donors once they have entered the voluntary blood donation     system and to increase the frequency of their donations.   "
162673|NCT00001909|"     Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow     obstruction. Fourteen million persons (6.4%) in the United States report having asthma, and     from 1980 to 1994 the prevalence of self-reported asthma in the United States increased by     75%. A major factor in the pathogenesis of asthma is the development of an allergic     inflammatory response to inhaled antigens. Interleukin-4 (IL-4) plays a key role in this     response by promoting IgE production, upregulating IgE receptors, upregulating adhesion     receptors such as VCAM-1, promoting Th2 cell development and increasing mucus secretion.     Soluble recombinantly produced IL-4R (sIL-4R) has been shown to bind and inactivate IL-4,     both in vitro and in animal models. As part of a multicenter trial, 20 subjects at the NIH     site will receive 0.9 mg., 1.8 mg. sIL-4R or placebo once weekly for 12 weeks in a double     blind placebo controlled study. Study drug will be delivered via the AERx aerosol drug     delivery device. The primary objective of the study will be to evaluate efficacy as measured     by FEV1. Secondary objectives will include changes in FVC, FEF 27-75, peak flow,     bronchodilator usage, asthma symptoms, quality of life scores, immunologic and inflammatory     markers, pharmacokinetics, safety and immunogenicity. The study population will consist of     moderate to severe asthmatics on (Beta)-agonist monotherapy with an FEV1 of 50-80% of     predicted. After 12 weeks of study drug, subjects will be followed for an additional 8 weeks.   "
162674|NCT00001910|"     This study will examine how allergen immunotherapy (allergy shots) works to reduce or prevent     reactions to allergens such as pollen, dust or cat dander. Certain T cells (types of white     blood cells) called Th2 cells produce substances that generate allergies. Other T cells     called Th1 cells produce substances that have opposite effects. This study will determine if     allergy shots change the immune response to allergens by reducing the number of Th2 cells or     by changing them into Th1 cells. A better understanding of how this treatment works may help     scientists develop more effective allergy therapies.      People between 18 and 50 years of age who have had allergic asthma for at least 1 year may     participate in this study. Candidates' medical, allergy and medication histories will be     reviewed, and they will have a physical examination, including routine blood tests,     urinalysis, electrocardiogram (EKG), and lung function test. Blood will also be drawn to test     T cell response to allergens, and 12 skin tests (similar to a tuberculosis skin test) will be     done to test for sensitivity to various allergens.      Participants will be admitted to the Clinical Center for 1 to 2 days for rush therapy (see     below). They will have a brief history and physical examination. A heparin lock (thin plastic     tube similar to an intravenous line) will be placed in an arm vein. They will then undergo     the following procedures:        -  Rush/Cluster Immunotherapy - An allergen is given in increasing doses over 2 to 5 weeks.          During rush therapy, the dose is increased rapidly over 1 to 2 days until a moderate          level dose is reached. To reduce the chance of an allergic reaction, patients take          prednisone, cetirizine (Zyrtec® (Registered Trademark)), ranitidine (Zantac® (Registered          Trademark)) and montelukast (Singular® (Registered Trademark)) starting 24 hours before          treatment begins until rush therapy ends. After discharge on the third day, patients          return to the clinic once a week for the next 2 to 5 weeks for cluster therapy, in which          the dose is increased more gradually to a maintenance level.        -  Maintenance Immunotherapy - Participants receive 12 weekly injections at the maintenance          dose. Blood is drawn during one visit between weeks 2 and 7 of maintenance therapy.        -  Follow-up Visits - Patients return to the clinic 2 and 3 weeks after the last          maintenance dose for blood draws and evaluations. In addition, a late-phase allergen          skin test is done at the 3-week follow-up to compare reaction results with those from          the test done at the screening visit.        -  End-of-Study Visit - 12 to 16 weeks after the last allergy shot, patients return for a          final blood draw and brief evaluation.   "
162675|NCT00001911|"     This study will test the safety and effectiveness of a drug called interleukin-12 (IL-12) in     fighting severe infectious (other than tuberculosis) caused by a group of bacteria called     mycobacteria. IL-12 is similar to a substance the body produces naturally to strengthen     immune function (infection-fighting ability). It works by stimulating white blood cells to     increase production of a chemical called interferon gamma, which can improve or cure     mycobacterial infections in some patients.      In previous studies, IL-12 has improved immune function against mycobacteria in test tube     experiments and in mice. A recent study of three patients with mycobacterial infections     treated with the drug showed encouraging results. The drug has also been studied more     extensively in patients with cancer, HIV infection and hepatitis C.      Patients in this study will receive IL-12 injections under the skin twice a week for one     year. They will be taught how to self-administer the drug, but a home care nurse or a     physician may also give the injections. The drug dosage will be increased each week to     determine the safest and most effective dose for fighting this infection. If intolerable side     effects develop at a certain dose, the previous dose level will be used for the next     injection. That dose will then be used for the rest of the study, unless unacceptable side     effects develop at that level, in which case the dose will again be lowered. Patients will     receive an antibiotic against mycobacteria.      Physical examinations and blood and urine tests will be done once a month for at least the     first year and then every 3 months the following year to evaluate kidney, liver, and immune     function. The first evaluation-at the start of the study-is done on an inpatient basis.   "
162676|NCT00001912|"     This study will examine what causes seizures in patients with cysticercosis (pork tapeworm     infection). A better understanding of this could lead to improved methods of controlling or     preventing seizures.      In humans, the pork tapeworm (Taenia solium) lives in the small intestine. The parasite's     microscopic eggs travel around the body-including to the brain-where they develop into cysts.     Usually, the cysts don't cause symptoms until they die. Then, they provoke an inflammatory     reaction that irritates the brain, causing seizures and other symptoms. The inflammation     eventually goes away, but the dead cysts remain. Calcium deposits often form where the cysts     are. Some of the calcified cysts develop swelling around them that seem to be associated with     the development of seizures.      This study will explore how and why these dead, calcified cysts continue to cause seizures.     In so doing, it will try to determine: 1) the best diagnostic imaging method for detecting     swelling around the cysts; 2) how often swelling occurs; and 3) what makes some cysts prone     to swelling and related seizure activity, while others are not.      Patients with cysticercosis who have had seizures or who have known or possible swelling     around calcified cysts will be studied with various tests, including magnetic resonance     imaging (MRI), computed tomography (CT) scans, electroencephalography (EEG), blood tests, and     possibly lumbar puncture. Patients will be studied for two cycles of seizures (during active     and quiet periods) or a maximum 4 years.   "
162777|NCT00002434|"     To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in     patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated     severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral     pentamidine).   "
162778|NCT00002435|"     To investigate the safety of thymic humoral factor (THF gamma 2), its effect on HIV load     based on at least a 75 percent decrease in HIV quantitative PCR RNA copies/ml, and its     persistence when administered in combination with an antiretroviral nucleoside derivative     (zidovudine; AZT). To assess the effects of THF gamma 2 on T-cells, quality of life, and     progression of disease.   "
162677|NCT00001913|"     This study uses functional magnetic resonance imaging (fMRI) to look at brain activity while     patients view pictures of people's faces that they are familiar with or have emotional     attachment to.      The functional MRI (fMRI) procedure allows researchers to see the brain at work. It uses     the same powerful magnetic fields and weak electromagnetic radiation (radiowaves) as standard     structural MRI. However, functional MRI can also show areas of increased blood flow, which     relates to increased activity by brain cells.      This research study builds on previous studies that identified specific areas of the brain     that are activated by visual stimuli showing faces. However, previous research used anonymous     faces as stimuli. This study will use faces of individuals known to the patient.      There are three experiments that will be conducted in the study;        1. Experiment 1 will attempt to determine the effects of familiarity of the photographed          face on brain activity patterns. Patients will view familiar faces, the faces of close          friends and relatives, and the faces of famous people.        2. Experiment 2 will look at how maternal attachment affects the response to visual          stimuli. Mothers will view pictures of their first born child, as well as those of          familiar children to whom they are not related, unfamiliar children, and unfamiliar          adults.        3. Experiment 3 will explore the effects of interpersonal attachment and loss on response          to visual stimuli. In this experiment, bereaved spouses will view pictures of their          deceased spouse, those of living family members, and those of unfamiliar people.   "
162678|NCT00001915|"     Attention deficit/hyperactivity disorder is a condition characterized by a decreased     attention span, hyperactivity, and/or impulsiveness inappropriate for a certain age.      Typically, young children have what are known as subtle neurological signs. These are     involuntary movements of one part of the body that occur while the child is making a     voluntary movement of another part of the body. This is referred to as synkinesis, or     overflow movements. These overflow movements disappear during normal development and are     usually gone by the age of 10. However, in children with ADHD these overflow movements tend     to be more intense and last long after the age of 10. This leads researchers to believe there     is an abnormality in the maturation and development of the brain areas associated with motor     activity in children with ADHD.      Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that gives information     about brain function. It is very useful when studying areas of the nervous system related to     motor activity (motor cortex, corticospinal tract, and corpus callosum). A magnetic signal     given from a special instrument held close to the patient's head stimulates a small area of     the brain that controls a few muscles (for example, the muscles that control one finger).     Doctors put electrodes (small pieces of metal taped to areas of the body) over the muscle to     measure the electrical activity the muscle produces when it makes a movement. When the     magnetic signal activates those muscles the electrodes pick up and record the electrical     activity of the movement that the muscles make in response to the magnetic signal.      Researchers will study normal children and those diagnosed with ADHD using TMS to find out if     the clinical abnormalities of ADHD are associated with a delay or abnormality in maturation     of areas of the nervous system responsible for motor activity (motor cortex and corticospinal     tract).   "
162679|NCT00001916|"     In this study researchers would like to learn more about the low levels of bone mineral     density seen in approximately half of women in their forties diagnosed as currently having or     previously had depression.      Bones are always undergoing a process of building (formation) and breakdown (resorption).     This process is referred to as bone remodeling. When more bone is formed than resorbed, the     density (level of calcium) in bone increases and the bones become stronger. However, if more     bone is resorbed than formed the density of bone decreases and the bones become weak. This     condition is called osteoporosis.      It is unknown if women with depression have decreased bone mineral density as a result of too     much breakdown of bone or not enough building. It is important to know the cause of low bone     mineral density because it will influence the way a patient is treated. Medications like     bisphosphonates are used when there is too much bone breakdown. Growth hormone replacement     can be given in cases where there is not enough bone production. Presently, bone biopsy and a     procedure known as histomorphometry can determine what processes are going on in bones.      Researchers have decided to use a sample of bone (biopsy) from part of the hip bone (iliac     crest). In addition, researchers will collect a sample of bone marrow (the soft tissue found     in the center of bones) to tell them more about the biochemical, cellular, and molecular     processes that may be contributing to the problem of decreased bone density in depressed     premenopausal women.   "
162680|NCT00001917|"     The purpose of this study is to use brain imaging technology to study the effects of aging     and Alzheimer's Disease (AD) on a specific type of brain receptor.      The brain is made up of cells called neurons. The neurons communicate with one another and     secrete chemicals called neurotransmitters. The neurotransmitters bind to specific sites on     other neurons called receptors. Acetylcholine (ACh) is a neurotransmitter that binds to ACh     receptors. In both aging and AD, the number of neurons that secrete ACh decreases and the     function of some ACh receptors changes. This study will use positron emission tomography     (PET) scans of the brain to study the effects of age and AD on muscarinic type 2 [M2], a type     of ACh receptor.      Participants in this study will be injected with a radioactive tracer (ligand [F-18] FP-TZTP)     which binds to [M2] receptors. Participants will then undergo a PET scan in order for the     density and function of [M2] receptors to be studied.   "
162681|NCT00001918|"     In 1989 more than 1500 people who took the dietary supplement L-tryptophan for insomnia and     depression developed eosinophilia myalgia syndrome (EMS)-a potentially fatal disease     characterized by an excess of a type of white blood cell called eosinophils. Disease symptoms     include fever, muscle aches and inflammation, and skin rashes. As many as 40 of the patients     who became ill died. It is suspected that impurities in the supplements caused the disease.     More recently, similar impurities have been detected in batches of a similar dietary     supplement called L-5-hydroxytryptophan.      This study is designed to learn more about EMS that develops in patients taking     L-5-hydroxytryptophan. The study is open to patients newly diagnosed with eosinophilia     myalgia who have taken L-5-HTP. Patients in the study will have a physical examination and     urine and blood tests. They may also have X rays, an electrocardiogram, magnetic resonance     imaging (MRI), and a skin test for tuberculosis. They will have a psychiatric interview, take     a memory test, and fill out questionnaires relating to sadness and depression.      Patients may also undergo special tests to study conduction of nerve impulses and muscle     function.      Samples of patients' supplements will be taken for chemical analysis.   "
162779|NCT00002436|"     To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in     combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination     with AZT.      PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label     combination therapy.   "
162788|NCT00002454|"     RATIONALE: Vaccines made from papilloma virus cells may make the body build an immune     response to and kill papilloma cells.      PURPOSE: Phase II trial to study the effectiveness of papilloma virus vaccine in treating     young patients with recurrent papilloma of the larynx.   "
162682|NCT00001919|"     St. John's Wort is a popular dietary supplement that many people take to elevate mood or     relieve stress. This study will test in normal volunteers whether this preparation may alter     mood and if so, by what means. Animal studies suggest that St. John's Wort may work similarly     to some antidepressants that affect levels of the chemical serotonin in the brain.      Participants in this study must also be enrolled in NIMH protocol #98-M-0094 (SPECT Imaging     of Dopamine and Serotonin Transporters in Neuropsychiatric Patients and Normal Volunteers)     and protocol #91-M-014 (MRI Imaging of Neuropsychiatric Patients and Controls). Separate     consent forms are required for each study. Candidates will undergo medical and psychiatric     evaluations that may include blood and urine tests, electroencephalogram and     electrocardiogram.      Normal volunteers will have a mood assessment at the beginning of the study. They will then     be randomly assigned to take either placebo (a pill with no active ingredient) or St. John's     Wort 3 times a day for 2 weeks, and will be told what they are taking. After an 11-week     hiatus, they will again start treatment on the same schedule, but will not be told which     preparation they are receiving. Each evening during the 2-week treatment periods, subjects     will complete a brief self-rating mood assessment questionnaire. At the end of each treatment     period, they will undergo SPECT brain imaging (a type of CT scan) to determine dopamine and     serotonin distribution and density in the brain.      For this procedure, study subjects take three drops of potassium iodide solution within 24     hours before the scan and two drops nightly for 3 days following the procedure. About 10 ml     (less than two teaspoons) of blood are drawn before a radioactive tracer is injected. SPECT     imaging is done the next day. After about 1 hour of imaging, subjects are given either a     placebo or St. John's Wort, and then imaging continues for another 2 hours. During the     procedure, up to five blood samples of 6 ml each may be drawn. At some point during the     study, a MRI scan of the brain will be done.   "
162683|NCT00001920|"     The purpose of this study is to explore how the brain works during particular memory tasks in     people with schizophrenia and healthy volunteers.      Research has shown that patients with schizophrenia have structural and functional     abnormalities in the hippocampus and cerebellum of their brains. These abnormalities are     likely associated with the memory impairment experienced by these patients. Eye blink tests     can provide information about memory acquisition involving the cerebellar and hippocampal     regions. By altering the stimuli interval, these tests can distinguish between     cerebellum-dependent memory associated with subliminal mnemonic encoding and     hippocampus-dependent memory associated with conscious awareness. This study will use     eyeblink tests to determine which type of memory is predominantly affected in schizophrenia.      Participants in this study will be screened with a physical and psychiatric examination.     Participants will have an electroencephalogram (EEG), an electrocardiogram (ECG), and an     electrodermal test. Evoked potentials and magnetic resonance imaging (MRI) scans of the brain     may also be taken.   "
162684|NCT00001921|"     This study will explore how the brain works during memory testing in an effort to understand     why some patients with schizophrenia have memory difficulties.      Patients with schizophrenia and their unaffected family members are eligible for this study.     Studying family members may help identify the genes related to the memory deficit in     schizophrenia. Normal volunteers will also be studied.      Normal volunteers, patients with schizophrenia, and their family members interested in     participating in this study will be screened with a complete medical examination and     psychiatric assessment, and performance of simple tasks. Study participants will be shown     numbers on a screen and asked to recall them after a brief period. This will be done during     electroencephalographic (EEG) recording, in which electrodes attached to the scalp measure     the brain s electrical activity. The same test will be repeated while the patient has     magnetic resonance imaging of the brain. The combined MRI and EEG testing will permit better     localization of the brain s electrical activity.   "
162685|NCT00001922|"     This research study is designed to improve understanding about voice disorders that are due     to uncontrolled muscle contractions affecting the voice box. The type of voice disorder     depends on which muscles of the voice box are involved. Abductor spasmodic dysphonia may lead     to a weak voice. Adductor spasmodic dysphonia may result in a strangled voice. Muscular     tension dysphonia may lead to a strained voice. Some of the major goals of the study are to;        1. understand how sensation from the voice box affects voice and speech production        2. develop better ways to diagnose sensation abnormalities affecting the voice box        3. determine if patients with voice disorders differ from persons without voice disorders          in the way they respond to sensory information from their voice box      Researchers believe that by understanding better how sensations of the voice box are     presented and how the muscles in the larynx respond to those sensations they will be able to     develop better treatments for patients suffering from voice disorders. ...   "
162686|NCT00001923|"     Phantom pain refers to the sensation of pain felt by patients who have had a limb amputated.     The treatment of phantom pain is often disappointing and is unable to provide adequate relief     to the patients. The area of the brain involved (posterior parietal cortex [PPC]) is found on     the opposite side of the amputated limb. For example, if a patient has the right arm     amputated, the left posterior parietal cortex is involved in the phantom pain.      Researchers believe that if they can decrease activity in the posterior parietal cortex they     may be able to reduce phantom pain.      Researchers plan to use low frequency (1 Hz) transcranial magnetic stimulation (TMS) to     decrease the excitability of the PPC opposite the side of the amputated limb. TMS involves     the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp and     turning on the magnetic flux. This permits non-invasive, relatively localized stimulation of     the surface of the brain (cerebral cortex). When an area of the brain is stimulated a period     follows when that area cannot be stimulated again. In this case, researchers plan to use TMS     to stimulate the PPC in order to decrease the level of excitability there.   "
162687|NCT00001925|"     Tremors are involuntary movements of a part or parts of the body that occur because of     alternating contraction and relaxation of muscles. The causes behind most tremors are poorly     understood.      Some studies suggest tremors could be caused by abnormalities in a particular area of the     brain called the olivary nucleus. Researchers believe that the cells making up the olivary     nucleus may be responsible for generating a central rhythm of the body and may therefore also     be responsible for the generation of tremors.      Consumption of alcohol has been known to reduce tremors in some patients. Researchers believe     that the alcohol may work directly on the cells of the olivary nucleus. As a result,     researchers would like to determine the effects of alcohol on three different kinds of     tremors (physiological, symptomatic palatal, and essential palatal).   "
162688|NCT00001926|"     The purpose of this study is to test the belief that specific areas of the brain are     connected differently in blind patients than patients with sight. In addition, the study will     examine the different anatomical connections between brain areas of patients who became blind     early in life versus patients who became blind later.   "
165934|NCT00005751|"     To determine whether the presence of endothelial dysfunction is an independent risk factor     for cardiovascular disease events.   "
162690|NCT00001928|"     Patients with Parkinson's disease have low levels of the neurotransmitter dopamine. Dopamine     is responsible for motor function and normal physical activity. Patients with Parkinson's     disease typically suffer from tremors, rigid muscles, stooped postures, and walk with a     shuffle. The drug levodopa acts as a replacement for dopamine and has been has been used     effectively for over 30 years as treatment for Parkinsons disease. Because of its     effectiveness, levodopa has been used to distinguish Parkinson's disease from other     conditions that may resemble Parkinson's disease.      Traditionally, levodopa has been given as a pill. In this study, researchers would like to     inject levodopa directly into a vein (intravenous) in order to diagnose cases of Parkinson's     disease. This method provides immediate results and allows doctors to adjust the dose of     levodopa very carefully. Because the intravenous method of giving levodopa is less practical     than oral medication, it is not an available alternative for the routine treatment of     Parkinson's disease. However, it may be useful for faster diagnosis of the disease and for     determining effective doses of oral medication.   "
162691|NCT00001929|"     Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This     occurs as a result of destructive changes in an area of the brain responsible for making     dopamine, the basal ganglia. Patients with the disease experience, rigid muscles, stooped     posture, and a shuffling-type walk (gait).      In this study researchers plan to evaluate the effectiveness of the drug eliprodil for the     treatment of Parkinson's Disease. Eliprodil works by blocking special receptors (NMDA) that     are associated with the symptoms of Parkinson's Disease.   "
162692|NCT00001930|"     Huntington's disease is a chronic disorder passed on through genetic autosomal dominant     inheritance. The condition usually begins between the ages of 30 and 50 years and it is     characterized by involuntary movements in the face and extremities, (chorea), accompanied by     changes in behavior and gradual loss of the mental function. The disease typically ends in a     state of disorientation, impaired memory, judgement, and intellect (dementia).      The objective of this study is to test the effectiveness of the drug amantadine for the     treatment of chorea associated with Huntington's disease. Amantadine is an antiviral drug     that has been used to treat a variety of illnesses including Parkinson's disease. Amantadine     works by attaching to special sites called NMDA (N-methyl-D-aspartate) receptors and blocking     the normal activity of glutamate there. Glutamate is an amino acid released by brain cells     and has been associated with the symptoms of Parkinson's disease.   "
162693|NCT00001931|"     Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This     occurs as a result of destructive changes in an area of the brain responsible for making     dopamine, the basal ganglia. Muscle tremors, rigidity of movement, shuffling footsteps,     droopy posture, and a mask-like expression on the face characterize Parkinson's disease.      This study is designed to determine the effects of a new drug, N-9023. The drug acts like     dopamine and can be given through a skin patch (transdermal) for treatment of parkinsonian     symptoms.      The goals of this study are to find out whether N-9023 is useful in treating the signs and     symptoms of Parkinson's disease and to determine the best dose of N-9023 that is safe and     effective.   "
162694|NCT00001932|"     Patients in this study will undergo PET scans (a type of nuclear imaging test) to look for     abnormalities in certain brain proteins associated with seizures.      Studies in animals have shown that serotonin-a chemical messenger produced by the     body-attaches to proteins on brain cells called 5HT1A receptors and changes them in some way     that may help control seizures. There is little information on these changes, however. A new     compound that is highly sensitive to 5HT1A, will be used in PET imaging to measure the level     of activity of these receptors and try to detect abnormalities. Changes in receptor activity     may help determine where in the brain the seizures are originating.      Additional PET scans will be done to measure the amount of blood flow to the brain and the     rate at which the brain uses glucose-a sugar that is the brain's main fuel. Blood flow     measurement is used to calculate the distribution of serotonin receptors, and glucose use     helps determine how seizures affect brain function.      The information gained from the study will be used to try to help guide the patient's therapy     and determine if surgery might be beneficial in controlling the patient's seizures.   "
162700|NCT00001940|"     Voriconazole is a new drug developed to treat fungal infections. As of March 1999, the drug     had been studied in more than 1,900 healthy volunteers or patients with fungal infections.     This study will test extended use of voriconazole in patients with serious fungal infections     for which there are no approved therapies, and in patients who did not improve with or could     not tolerate standard therapy. It will evaluate the drug's safety, effectiveness, and     toleration in these patients.      Patients previous enrolled in protocol 99-C-0094 who improved with voriconazole treatment are     eligible for this study. Before beginning treatment, patients will have a physical     examination, including blood and urine tests, and an eye examination. They may also have     X-ray or CT imaging. Voriconazole will then be given twice a day either by infusion into a     vein or by tablets taken by mouth for up to 12 weeks. Patients will be examined at weeks 4, 8     and 12 of the study and one week after treatment stops. Blood and urine samples will be     collected at each visit. An eye examination will be done at the end of the treatment period     and at other visits if vision problems develop.      Voriconazole is active against fungal infections and may produce fewer side effects than     standard therapy.   "
162701|NCT00001941|"     The purpose of the study was to determine: (1) the toxicity and maximum tolerated dose (MTD)     of humanized anti-Tac (daclizumab), (Zenapax(Registered Trademark)) in patients with adult     T-cell leukemia/lymphoma (ATL); (2) to define the dose of Zenapax(Registered Trademark)     required to saturate interleukin 2 receptor alpha (IL-2R) alpha in patients with ATL; (3)     determine the clinical response to humanized (Hu) anti-Tac (Zenapax(Registered Trademark) of     patients with Tac-expressing adult T-cell leukemia; and (4) determine the serum dieaway curve     (pharmacokinetics) of infused humanized (Hu)-anti-Tac in patients who have ATL. This study     represented an extension of Metabolism Branch National Cancer Institute (NCI) protocols     utilizing modifications of the original murine anti-Tac monoclonal antibody (mAb) developed     by our group for the treatment of ATL. The scientific basis for these therapeutic studies is     that the leukemic cells of patients with ATL express abnormally high levels of the Tac     antigen (IL-2R alpha) on their surface whereas resting normal cells including normal T-cells     of the patients do not. One presumed mode of action of Hu-anti-Tac in the treatment of ATL     involves the interruption of the interaction of interleukin 2 (IL-2) with its growth factor     receptor. To be effective in this goal we must maintain saturation of the IL-2 receptors     (IL-2R) with humanized anti-Tac thereby preventing IL-2 mediated proliferation and yielding     cytokine deprivation and apoptotic cell death of the leukemic cells. Eligible patients with     ATL were treated with escalating doses of Zenapax(Registered Trademark) between groups in the     Clinical Center of the National Institutes of Health (NIH). Groups of patients received     sufficient Zenapax(Registered Trademark) to yield saturation of the IL-2 receptor for a     period of 17 weeks. Clinical response was evaluated using routine immunological and clinical     evaluation and by monitoring the saturation of the IL-2R and the absolute number of residual     circulating malignant cells by fluorescence activated cell sorting (FACS) analysis using two     fluorochrome-labeled non-crossreacting antibodies to the IL-2 receptor, anti-Tac and 7G7/B6,     as well as antibodies to cluster of differentiation 3 (CD3), cluster of differentiation 4     (CD4), cluster of differentiation 7 (CD7), and cluster of differentiation 8 (CD8).     Furthermore, responses were evaluated in patients with leukemia by Southern blot analysis of     the arrangement of the T-cell receptor genes and human T-lymphotropic virus type 1 (HTLV-I)     integration. Finally, in select patients, to define the pharmacokinetics of the therapeutic     antibody, had planned to monitor the serum levels of the infused Hu-anti-Tac     (Zenapax(Registered Trademark)) as a function of time. This study is an essential element of     our program involving IL-2R-directed therapeutic studies. If as anticipated the therapy with     humanized anti-Tac yields some partial and complete remissions in patients with ATL, we will     propose that it be used as a single agent for patients with smoldering and chronic ATL and in     association with chemotherapeutic agents to provide a novel approach for the treatment of     acute and lymphoma forms of ATL. We also plan a future clinical trial where tentative plans     also had been made to evaluate the efficacy and toxicity in ATL patients of saturating doses     of Zenapax(Registered Trademark) as compared to identical doses of Zenapax(Registered     Trademark) given in association with (90)Y-armed 7G7/B6, a non-competing antibody to IL-2R     alpha or in combination with chemotherapy.   "
162706|NCT00001951|"     The human ovary produces male sex hormones (androgen) and female sex hormones (estrogen).     Currently, androgen is not included in hormone replacement therapy for women with premature     ovarian failure. Present hormone replacement therapy (HRT) was designed to treat women who     experience ovarian failure at menopause (around the age of 50). However, 1% of women will     experience premature failure of the ovaries before the age of 40. There have been no studies     conducted to determine proper hormone replacement therapies for these younger women. Some     research suggests that the usual menopausal hormone replacement therapy is not adequate to     protect young women with premature ovarian failure from developing osteoporosis. Women with     premature ovarian failure have abnormally low levels of androgens circulating in their blood.     This may contribute to the increase risk for osteoporosis.      This study will compare two treatment plans for women with premature ovarian failure.     Treatment plan one will be physiological estrogen hormone replacement. Treatment plan two     will be physiological estrogen hormone replacement plus androgen. The study will attempt to     determine which plan is more beneficial to women in relation to osteoporosis and heart     disease.      The hormones will be contained in patches and given by placing the patches against the     patient's skin. The patches were designed to deliver the same amount of hormone as would be     normally produced by the ovary in young women.      The success of the treatment will be measured by periodically checking the density of     patient's bone in the leg (femoral neck bone) . Researchers will take an initial (baseline)     measurement of bone density before beginning treatment and then once a year, for 3 additional     years, during treatment. The study will also consider bone density of the spine, bone     turnover, heart disease risk factors, and psychological state.   "
162695|NCT00001933|"     Some of the thinking difficulties of Alzheimer's patients may be due to a deficiency in a     brain chemical called acetylcholine, which helps transmit messages between nerve cells.     Nefiracetam is a new drug that stimulates acetylcholine. This study will test whether     Nefiracetam can safely improve memory, thinking and activities of daily living in patients     with mild to moderate intellectual impairment due to Alzheimer's disease.      Patients in the study must have a caregiver and designated representative. Candidates will be     given a medical history and physical examination that includes a complete neurologic and     neuropsychologic evaluation, blood tests, and an electrocardiogram. A chest X ray and     magnetic resonance imaging (MRI) test will be done on patients who have not had these tests     within the previous two years. During the 20-week study, each patient will take three pills     twice a day for twenty weeks of either Nefiracetame or placebo (sugar pill). Neither the     patients nor the doctors will know which patients are getting the drug and which are getting     the placebo. Blood and urine tests will be done frequently throughout the study. Patients     will be asked to have a spinal tap (on a voluntary basis) to measure the levels of drug in     the spinal fluid, and a PET scan (a brain imaging test).      At the end of the study, patients who feel they are doing well with no side effects from the     drug (or placebo) may be given the option of continuing treatment for another seven months.      Animal studies showed that Nefiracetam improved learning impairment and memory in rats with     dementia. In a small study of humans, about one-fourth of patients who were given a low dose     of the drug had improved intellectual function, and about one-half who received a higher dose     improved.   "
162696|NCT00001934|"     This study will examine the safety and effectiveness of Zenapax (a laboratory-manufactured     antibody) in treating multiple sclerosis. Multiple sclerosis may be caused by an abnormal     immune response in which white blood cells called T lymphocytes attack the myelin sheath that     covers nerves and parts of the spinal cord. Zenapax binds to protein receptors on     lymphocytes, keeping them from interacting with interleukin-2, a substance necessary for     their growth.      Patients with multiple sclerosis who have had at least one relapse within 18 months of the     start of the study and in whom interferon-beta treatment has not been successful may be     considered for this study. There are two study phases: baseline and treatment. During the     baseline phase, patients will have three magnetic resonance imaging (MRI) scans over 2 months     to evaluate their disease activity. During treatment, patients will receive seven intravenous     (I.V.) infusions of Zenapax in the clinic. The first two infusions will be given 2 weeks     apart; the next five will be given once a month.      Patients will have MRI scans before each infusion. The MRIs will be done using the standard     procedure and again using a contrast agent, gadolinium, injected into a vein. Gadolinium     helps identify new multiple sclerosis lesions in the brain. Blood and urine samples will be     taken during each clinic visit. In addition, patients will have skin tests, similar to a     tuberculin test, to evaluate immune status, and will be asked to undergo two lumbar punctures     (spinal tap; these will be optional)-one before the treatment phase begins, and another when     treatment is completed. Lymphocytes will also be collected from patients before, during and     after treatment. The lymphocytes are obtained by a procedure called apheresis: about a pint     of whole blood is drawn through a needle in the arm, the lymphocytes are separated out and     removed by a machine, and the rest of the blood is returned through a needle in the other     arm. These studies will hopefully allow conclusions about the safety of Zenapax in MS, but     also address its effectiveness with respect to modifying the inflammatory activity in the     brain of MS patients and inhibit autoimmune T lymphocytes that are involved in the disease     process.   "
162697|NCT00001936|"     The purpose of this study is to determine the feasibility of using extrinsic laryngeal muscle     stimulation to elevate the larynx in a manner similar to that which occurs during normal     swallowing. This research will also determine whether laryngeal elevation will open the upper     esophageal sphincter to assist with entry of the bolus into the esophagus. This protocol     includes studies in normal volunteers and patients with swallowing disorders. The outcome of     this study will be relevant to future use of neuromuscular stimulation for laryngeal     elevation in patients with pharyngeal dysphagia....   "
162698|NCT00001937|"     Fever and infection are serious complications of cancer treatment such as bone marrow     transplant, especially when white blood cell counts are low. When the number of white blood     cells is below 500, the person has a condition called neutropenia and has a high risk of     developing an infection. At the first sign of fever, antibiotics are started. However,     antibiotics do not kill fungus germs, and fungal infections may be difficult to treat. Thus,     the prevention of fungal infections in this population is important. The only medicine     approved for prevention of fungal infections is fluconazole, which prevents some but not all     types of such infections. A new antifungal medication called FK463 works against more types     of fungal infections than fluconazole does. This study will compare the effectiveness,     safety, and tolerance of FK463 as compared with fluconazole.      Eight hundred patients will be enrolled in this study. They will be randomly assigned to     receive either fluconazole or FK463. Before the medicine is begun, a physical exam as well as     a blood sample, mouth swab, urine sample, and chest x-ray will be done. The fluconazole or     FK463 will be administered once a day for one hour into the bloodstream through a catheter in     the vein. Blood tests will be taken twice a week. Cultures from the blood, mouth, and urine     will be taken throughout the study. X-rays and CT scans will only be taken if a fungal     infection is suspected. If fever develops, blood will be drawn to check for fungi. If fever     and neutropenia continue for more than 4 days, FK463 or fluconazole will be stopped and a     standard medication called amphotericin B will be started.      Both FK463 and fluconazole will be administered until white blood cell count returns to     greater than 500 (signifying recovery from neutropenia), or up to 42 days after     transplantation. Patients will be evaluated 4 weeks after the medicine is stopped.   "
162699|NCT00001938|"     Every cell in the human body contains hundreds of thousands of genes and the proteins made by     the genes. Sometimes changes take place in the genes or proteins that may make the cells more     likely to develop into cancer. An experimental protein profile test that finds these changes     may be able to provide information about whose cancer will stay in remission and whose will     return.      Volunteer patients whose epithelial ovarian cancer is in remission are eligible for this     study. Specimens will be collected from blood, saliva, and urine for the first protein     profile test. Sample sets for more protein profile tests will be collected at follow-up     visits 1 month and 3 months later and every 3 months afterward. If and when the cancer     returns, an additional sample set will be obtained and a biopsy of the relapsed tumor will be     taken both for a protein profile test and for review of the function and structure of the     disease (pathology review). The protein profiles from these samples will be compared to those     samples already collected to detect protein pattern changes. The amount of lysophosphatidic     acid (LPA) in the blood, a sign of ovarian cancer, will also be measured to see if LPA is     useful in detecting the return of ovarian cancer.      If patients get fluid in the stomach or chest, it will be tested for cancer cells and     proteins made by the tumor. If a physical exam or CT scan indicates a possible return of the     cancer, a biopsy will be performed and a sample saved for a protein profile.   "
162780|NCT00002437|"     To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can     extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS     patients. To evaluate the safety and tolerance of HPMPC therapy when administered by     intravenous infusion in AIDS patients with CMV retinitis that is not immediately     sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV     shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual     acuity.   "
165935|NCT00005752|"     To examine the effects of ethnicity, socioeconomic status (SES) and behavior in overweight     adults.   "
162702|NCT00001944|"     Tumor resistance to anti-cancer drugs is a major problem in cancer treatment. Studies have     found that a protein (P-glycoprotein) on some cancer cells pumps chemotherapy drugs out of     the cells, reducing treatment effectiveness. In laboratory tests, an experimental drug called     XR9576, has blocked pumping by this protein. It is being used in this study to try to     increase the amount of the anti-cancer drug vinorelbine, in cancer cells. Vinorelbine has     been shown in several clinical trials to be effective against some advanced cancers,     including breast, lung and ovarian, and is one of the drugs pumped out of tumor cells by     P-glycoprotein.      Patients with cancer 18 years and older may be eligible for this study. Candidates will be     screened with tests that may include blood and urine tests, electrocardiogram,     echocardiogram, CT scans, X-rays, and nuclear medicine studies. A tumor biopsy may be done     for diagnostic or research purposes.      Study participants will undergo tumor imaging with the radioactive drug Tc-99m Sestamibi.     This drug accumulates in tumor cells and is eliminated from them in much the same way that     some cancer drugs are eliminated from cells. The drug is injected into a vein and a series of     pictures are taken with a gamma camera. After this baseline scan, patients will receive a     dose of XR9576 and undergo a second scan 24 hours later. The scan will show whether XR9576     affects the accumulation and elimination of Sestamibi in tumor cells. This procedure may     provide a way to monitor cancers for evidence of chemotherapy resistance and show if XR9576     can improve the effectiveness of therapy.      At least 10 days after the baseline and XR9576 scans, patients will begin the first of 3 or     more 21-day cycles of vinorelbine treatment. On days 1 and 8 of each cycle, patients will     receive a 30-minute infusion of XR9576 intravenously (through a vein) followed by     vinorelbine, infused over a 6- to 10-minute period. (In some patients, XR9576 will be     administered before only one of the two vinorelbine dosages.)      Physical examination, blood tests, and other procedures may be done periodically to monitor     treatment.   "
162703|NCT00001946|"     This study will evaluate ways to improve magnetic resonance angiography (MRA) for diagnosing     atherosclerosis (hardening and narrowing of the arteries).      MRA is a new method for looking at arteries and veins without standard angiography, which     requires inserting a catheter into a blood vessel, injecting a contrast material, and     obtaining X-ray images. Current MRA techniques, however, do not depict the lumen (cavity) of     small vessels well enough to accurately determine the extent of their narrowing. This study     will test image processing methods with the eventual goal of improving MRA accuracy to the     point that it can replace X-ray catheter angiography for diagnosing atherosclerotic disease.      Patients with atherosclerosis who have had conventional angiography at Suburban Hospital in     Bethesda, MD, may be considered for this study. They will be screened with a brief history     and physical examination, and those enrolled will have a MRA scan within 72 hours of their     conventional angiogram. For this procedure, a catheter is placed in a vein in the patient's     arm and the patient lies on a table that slides into a magnetic resonance imaging (MRI)     scanner-a large donut-shaped machine with a magnetic field. Surface coils-flexible, padded     antennae used to improve the quality of the pictures-are wrapped around the patient's legs.     At times during the scan, the patient is asked to hold his or her breath for several seconds,     and a contrast material called gadolinium is injected through the catheter in the vein. This     substance enhances the images of blood flow in the vessels. The procedure generally takes     about an hour and a half, although the actual imaging takes only a small part of that time.   "
162704|NCT00001948|"     This study will examine and compare the health-related quality of life and degree of symptom     discomfort in two groups of patients receiving intensive drug therapy for HIV infection. One     group will receive continuous treatment over the entire 88-week study period; the other will     have interruptions in therapy over the same time period.      Patients enrolled in the National Institute of Allergy and Infectious Disease's trial,     Immunologic and Virologic Studies of Intermittent versus Continuous HAART [highly active     antiretroviral therapy] in the Treatment of HIV Disease, may participate in this study. At     periodic intervals for a total of 7 times during the 88-week trial, this companion study will     require participants in both the interrupted and the continuous therapy groups to complete     the following two questionnaires:        1. MOS-HIV Health Survey - The patient provides a self-assessment of his or her physical          and emotional well being. Survey questions are related to the ability to perform work          and daily living activities, mood and state of mind, limitations on social activities,          ability to concentrate, energy level, pain level, general quality of life, etc.        2. Symptom Distress Scale - The patient rates the degree of symptom distress by ranking          from 1 to 5 his or her agreement with statements about various physical and emotional          factors, including appetite, nausea, breathing, cough, pain, insomnia, fatigue, bowel          problems, concentration, appearance, and outlook.      Understanding the impact of HIV treatments on health-related quality of life and symptom     distress may provide information helpful in evaluating new treatment approaches.   "
162705|NCT00001950|"     It is commonly believed that objects in the world can be categorized in at least three     different ways or levels. The three levels are basic, superordinate, and subordinate.     Previously it was believed that basic categorization presents a cognitive (mental) advantage     to children's development. However, recent studies on superordinate categorization has     challenged this belief.        1. <TAB>Items in superordinate are grouped according to functional purpose, even though          they may not share any similarities in how they look (perception). For instance, desks,          chairs, and beds do not appear similar but they can be group together in the          superordinate category of furniture.        2. <TAB>Items in basic categorization share similarities in function and in perception. For          instance, chairs can be considered as a basic category. Chairs can share functional and          perceptual similarities with many kinds of chairs but are readily distinguished from          other types of furniture like beds or desks.        3. <TAB>Subordinate categories are subsets of basic categories. For instance, kitchen          chairs, desk chairs, and high chairs, are all within the basic category of chairs. Each          one is very similar in it's function to the others but is definitely discriminable.      This study was developed to investigate the development of categorization at all three levels     by using a design in which children between the ages of 1 and 3 years are tested for     categorization at all three levels with sets of objects from the same domain (such as vehicle     or fruit). Researchers plan to chart when infants develop categorization at the basic,     subordinate, and superordinate levels over the two-year period.<TAB>   "
162781|NCT00002438|"     To assess the safety and efficacy of itraconazole versus placebo for prevention of     histoplasmosis in HIV-infected patients with CD4 counts < 150 cells/mm3 who reside where     histoplasmosis is endemic. To assess the safety and efficacy of itraconazole for preventing     other debilitating fungal infections, such as cryptococcosis, aspergillosis, recalcitrant     oropharyngeal or vaginal candidiasis, and recurrent esophageal candidiasis.   "
162782|NCT00002439|"     The purpose of this study is to see if ALRT1057 gel is safe and effective in treating     Kaposi's sarcoma (KS) when applied to skin .   "
165936|NCT00005753|"     to develop the maximally effective treatment strategy for chronic sleep-onset insomnia and to     reduce its impact on psychological functioning, health, and economic sequelae.   "
162707|NCT00001952|"     The effectiveness of local anesthetics is reduced if inflammation is present, making it     difficult to control pain during such procedures as root canals and wisdom teeth removal.     This set of studies will assess the effectiveness of the opioid (synthetic narcotic) fentanyl     in enhancing the local anesthetic lidocaine (delivered with epinephrine) when used on     inflamed molar teeth.      In the first study, a topical anesthetic patch or a placebo will be placed on the gum tissues     next to four or five lower posterior teeth. The patch will removed at either 5, 10, or 15     minutes. An electronic test that sends a light electronic impulse into the tooth, lip     sensitivity testing (Is your lip numb?), and discomfort reports will be started immediately     after removal of the patch and repeated every 5 minutes for 30 minutes. An oral surgeon will     then remove the patient's wisdom teeth (tooth).      In the second and third studies, a topical anesthetic will be placed on the gum tissue. An     electronic test that sends a light electronic impulse into the tooth, lip sensitivity testing     (Is your lip numb?), and discomfort reports will be started and done several times     throughout the test. Then two small openings, one on each side of the tooth, will be drilled     into the bony tissues surrounding the tooth. A narcotic drug fentanyl or a placebo drug will     be delivered through these openings, allowing placement of the drug next to the nerves that     are difficult to numb. Lidocaine, along with a small amount of epinephrine, will be     delivered. An oral surgeon will then remove the patient's wisdom teeth or tooth (study 2) or     do a root canal (study 3).      In the fourth study, a topical anesthetic will be placed on the gum tissue. Then two small     openings, one on each side of the tooth, will be drilled into the bony tissues surrounding     the tooth. A narcotic drug fentanyl or a placebo drug will be delivered through these     openings. Lidocaine, along with a small amount of epinephrine, will be delivered at one of     three rates (15 patients for each rate). Blood pressure, heart rate, and breathing rate will     be taken before the topical anesthetic patch is applied, 2 minutes after, and every 5 minutes     for the next 45 minutes. Blood samples will be taken 6 times over the course of 60 minutes.     When testing is complete, an oral surgeon will remove the wisdom teeth (tooth). One month     later, blood samples will be taken using a different drug delivery method in order to compare     results.   "
162708|NCT00001953|"     This study aims to learn more about how the immune and hormonal systems function in patients     with Sjogren's syndrome, a disease in which the immune system does not function properly.     Adult nonpregnant females are invited to participate. Oral contraceptives may not be taken     for 6 weeks before and during this study, so another form of birth control must be used, such     as abstinence.      There will be two visits. At the first visit, a medical history and physical examination will     be conducted, and blood and urine tests will be done. The total amount of blood drawn will be     10 tablespoons. This visit will last 3 hours. At the second visit, participants will have an     oral glucose tolerance test. To prepare for it, they must be on a special diet for 3 days     beforehand and keep a diary of eating, sleeping, and physical activities for those 3 days. A     urine sample will be taken at the beginning of the visit. Subjects must then drink a very     sweet carbonated cola. A small plastic tube will be placed into an arm vein. Blood will be     drawn through this tube eight times over 3 hours. The total amount of blood drawn will be 17     tablespoons.      Only minor inconveniences are anticipated as a result of participating in this study. Risks     from blood tests include soreness, bruising, and minor infection at the puncture site, and     dizziness. The oral glucose tolerance test may cause temporary stomach bloating, headache,     nausea, and vomiting.   "
162709|NCT00001954|"     This study will test the effectiveness of etanercept (Enbrel) for treating Sjogren's     syndrome-an autoimmune disease that affects the secreting glands. (In autoimmune diseases,     the immune system attacks the body's own tissues.) Reduced lacrimal (tear) gland function     causes dry eyes with a scratchy sensation, and, in severe cases, vision be may impaired.     Reduced salivary gland function causes dry mouth, resulting in greatly increased tooth decay.     Dry mouth also makes chewing and swallowing difficult, which may lead to nutrition     deficiencies. Sjogren's syndrome can also cause dryness of the skin and of mucous membranes     in the nose, throat, airways, and vagina.      Patients with Sjogren's syndrome who have had oral and eye examinations under NIDCR's     protocol 84-D-0056 may participate in this study. Participants will be randomly assigned to     receive either etanercept or placebo (an inactive look-alike substance) by injection under     the skin twice a week for 3 months.      Patients will be seen for evaluation before treatment begins (baseline) and again at 1, 3,     and 4 months. The baseline and 3-month visits include a physical examination, eye     examination, saliva collection from salivary glands, blood tests, and evaluation for changes     in symptoms and treatment side effects. The 1- and 4-month visits include saliva collection,     blood tests, and review of symptoms and treatment side effects. In addition, blood will be     drawn every 2 weeks for safety monitoring. Patients will also be surveyed weekly (by     telephone or during the clinic visit) about symptoms and treatment side effects.      The Food and Drug Administration has approved Enbrel for treating certain forms of arthritis,     which, like Sjogren's syndrome, are autoimmune disorders of the connective tissue. Laboratory     studies also indicate that etanercept may be an effective treatment for Sjogren's syndrome.   "
162710|NCT00001955|"     This 2-part study will evaluate the effectiveness and side effects of two anti-inflammatory     drugs for relieving pain and improving jaw function in patients with temporomandibular     disorder (TMD). Part 1 will evaluate celecoxib (Celebrex); Part 2 will evaluate etanercept     (Enbrel). The Food and Drug Administration has approved both of these drugs for treating     certain forms of arthritis.      Patients between the ages of 18 and 65 years with painful jaw joint conditions may be     eligible for this study. Candidates will complete several written questionnaires about their     jaw condition and will undergo a medical history, complete TMD evaluation, blood and urine     tests, and imaging studies of the temporomandibular joint, such as X-rays and magnetic     resonance imaging. Patients will rate the quality and intensity of their pain before     beginning treatment. At certain periods during the study, they will also keep a pain diary,     twice a day recording the intensity and magnitude of their pain.      Part 1 - Celecoxib: Patients will be randomly assigned to receive either 1) celecoxib twice a     day by mouth; 2) naproxen (a non-steroidal anti-inflammatory drug) twice a day by mouth; or     3) a placebo (inactive pill) twice a day by mouth.      Part 2 - Etanercept: Patients will be randomly assigned to receive either 1) etanercept     injected under the skin or 2) saline (an inactive placebo) injected under the skin. Patients     in this group will also undergo two aspirations of fluid from the jaw joint - once before     treatment begins and again 6 weeks later. For this procedure, the joint is numbed with an     anesthetic and then a needle is inserted into the jaw space to withdraw fluid, which will be     analyzed for inflammatory processes in the joint.      All patients will have a final evaluation 6 weeks after beginning treatment, including a TMD     physical examination, laboratory and X-ray tests as required. The pain diary and     questionnaires will be collected at this visit.   "
162725|NCT00001971|"     The proposed study aims to evaluate, investigate, and follow-up patients suffering from acute     and chronic liver disease. The study will focus on understanding diseases affecting the     liver.      Patients participating in the study will first undergo a routine check-up as an outpatient.     They will be asked to provide blood and urine samples for laboratory testing and will undergo     an ultrasound of the liver. Ultrasound examinations use sound waves to determine the size and     texture of the liver. After the initial visit subjects will be requested to follow-up once a     year at the outpatient department for a similar check-up.      Additional tests may be requested throughout the study to provide information for other     research studies and individual consent will be requested. These tests may include liver     biopsies, skin biopsies, and / or specialized blood, plasma, and lymphocyte examinations.      Subjects that qualify for medications presently being studied may be offered the opportunity     to benefit from experimental therapy.   "
162726|NCT00001972|"     The main source of energy for the brain comes from a combination of oxygen and glucose     (sugar). For brain cells to function normally they must receive a constant supply of these     nutrients. As areas of the brain become more active blood flow into and out of these areas     increase.      In addition to oxygen and glucose, the brain uses chemical compounds known as phospholipids.     These phospholipids make up the covering of nerve cells that assist in the transfer of     information from cell to cell. Without phospholipids brain cell activity may become abnormal     and cause problems in the nervous system.      Certain diseases like Alzheimer's disease and brain tumors can affect blood flow to the brain     and change the way the brain metabolizes phospholipids. In addition to diseases, changes in     the brain occur with normal healthy aging.      This study is designed to use PET scan to measure changes in blood flow and changes in     phospholipid metabolism. Using this technique, researchers can improve their understanding of     how certain diseases change the shape and function of the brain.   "
162711|NCT00001956|"     The purpose of this study is to learn more about the role of genetics in pain sensitivity.     Pain perception varies widely among individuals, and information gained from this trial may     lead to better methods of preventing and controlling pain. The study consists of two parts,     described below. All enrollees will participate in part 1; patients needing oral surgery for     removal of third molars may also participate in part 2.      Normal volunteers, oral surgery patients, and family members of both groups may be eligible     for this study.      Part 1 -Sensitivity testing for hot and cold. Participants will rate their pain response to     hot and cold stimuli on a scale from no pain to the worst pain imaginable. Heat     sensitivity is measured using a small probe placed on the skin for a few seconds. The hottest     temperature tested may cause pain for a few seconds but will not produce a burn. Response to     cold is measured by placing the hand in cold water for up to 3 minutes and occasionally     flexing the fist. Participants will rate their pain level every 15 seconds. In addition to     the testing, a blood sample will be drawn to examine for genes related to pain.      Part 2 - Oral surgery. Patients will have their third molar removed under a local anesthetic     (lidocaine) injected in the mouth and a sedative (Versed) given through a vein in the arm. A     small tissue biopsy will be taken from the tissue over one of the third molars. Patients will     stay in the clinic for up to 7 hours after surgery while the anesthetic wears off and will     rate any pain they may have according to the rating scale used in Part 1 of the study. Pain     medication (ketorolac, or Toradol) will be given when needed, and patients will complete pain     questionnaires for 3 hours after the drug is given to rate its effectiveness. Patients will     receive additional pain relievers, if needed. A second biopsy on the side opposite the first     will be taken under local anesthetic to measure changes in chemical signals produced in     response to the surgery.   "
162712|NCT00001957|"     This study aims to increase our understanding of the difficulty people have recognizing the     spoken word, especially in noisy situations.      Subjects must be between 12 and 18 years old with no history of voice disorder, autism,     stuttering, aphasia, multiple sclerosis, traumatic brain injury, severe language disorders,     and psychiatric disorders. Group A subjects must show reduced speech-in-noise scores and     Group B subjects must demonstrate speech-in-noise scores within normal limits.      The child will perform a series of hearing tasks that will take from 1.5 to 2 hours, with a     break halfway through. A routine hearing test will be given. The child will sit in a     sound-treated room wearing earphones and will depress a button in response to sound or to     repeat words. The words may be in quiet or mixed with noise. In a test called immitance,     air pressure change and tones will be sent through a miniature probe in the ear for about 1     minute. TEOAE (transient-evoked otoacoustic emission) testing will test the inner ear with     clicking sounds. At times, noise will be presented through a probe in the opposite ear.      The child will listen to a series of recordings of speech in quiet and in noise and will be     asked to repeat what is heard. These recordings will include monosyllabic words with some     part of the sounds cut out; words presented with several voices speaking together; two words     presented at the same time, one to each ear (child must repeat both words); and two sentences     presented at the same time, one to each ear (child must repeat sentence presented to chosen     ear).      The only risk in this study is tiredness from listening.   "
162713|NCT00001958|"     This 12-month study will evaluate the safety and effectiveness of hydroxyurea in treating     beta-thalassemia, a type of anemia caused by defective hemoglobin (the oxygen-carrying     pigment in blood). Hemoglobin is composed of two protein chains-alpha globin chains and beta     globin chains; patients with beta-thalassemia do not make beta globin. Patients often require     frequent red blood cell transfusions. This leads to iron overload, which, in turn, requires     iron chelation therapy (removal of iron from the blood).      Some drugs, including hydroxyurea, can stimulate production of a third type of protein chain     called gamma chains. In the womb, the fetus makes this type of protein instead of beta     globin. It is not until after birth, when the fetus no longer produces gamma globin that the     beta globin deficiency becomes apparent. Gamma chain synthesis improves hemoglobin and red     blood cell production, correcting the anemia. This study will determine if and at what dose     hydroxyurea treatment reduces patients' need for red blood cell transfusions and whether     certain factors might predict which patients are likely benefit from this treatment.      Patients 15 years and older with moderately severe beta-thalassemia may be eligible for this     study. Participants will take hydroxyurea daily at a dose calculated according to the     patient's body size. Blood will be drawn weekly to measure blood cell and platelet counts.     The drug dosage may be increased after 12 weeks of treatment and again after 24 weeks if the     white cell and platelet counts remain stable. Patients who respond dramatically to treatment     may continue to receive hydroxyurea for up to 3 years.   "
162714|NCT00001959|"     This study will examine the effectiveness of the drug pirfenidone in treating focal segmental     glomerulosclerosis (FSGS). Patients with this disease have kidney fibrosis (scarring) and     proteinuria (excessive excretion of protein in the urine). About half of patients with FSGS     eventually require kidney dialysis or transplant. Steroids, which are currently used to treat     the disease, are effective in only a minority of patients. Other drugs, such as cyclosporin     and cyclophosphamide, improve proteinuria in a very small percentage of patients and have     serious side effects.      Patients with FSGS who wish to participate in this study will undergo pre-study evaluation     with blood and urine tests. Patients must be on a stable dose of an ACE inhibitor (a drug     that lowers blood pressure and reduces proteinuria) for at list 6 months before starting     pirfenidone therapy. (Patients who are not already taking an ACE inhibitor will be started on     the drug; those who cannot tolerate ACE inhibitors will be given a different drug.) Patients     with elevated cholesterol will take a cholesterol-lowering drug. A diet containing     approximately 1 gram of protein per kilogram of body weight per day will be recommended.      Patients will take pirfenidone by mouth 3 times a day for 12 months. Blood and urine will be     tested once a month, either at NIH or by the patient's local kidney specialist. They will     collect two 24-hour urine samples at the beginning of the treatment period, at 2-month     intervals throughout the study, and at a 6-month follow-up. Patients will also be asked to     give three to five tubes of blood and urine samples for analysis during the study.      In animal studies, pirfenidone improved kidney function and proteinuria and reduced kidney     scarring in rats with a disease similar to FSGS. In human studies, pirfenidone improved     breathing and survival in patients with lung fibrosis.   "
162715|NCT00001960|"     A heart condition called hypertrophic cardiomyopathy (HCM) causes abnormal thickening of the     heart muscle, which obstructs the flow of blood out of the heart. The thickened muscle and     the obstruction of blood flow are believed to cause chest discomfort, breathlessness,     fainting, and a sensation of heart pounding. Treatment options for children with HCM include     medicine, heart operation, and cardiac transplantation. However, there is no evidence that     medicine prevents further thickening of heart muscle; operations carry the risk of death; and     donor hearts are not always available. Several studies have shown that pacemaker treatment     reduces the obstruction and improves heart complaints in patients with HCM. This study     investigates further the efficacy of pacemaker treatment in children.      Patients will have exercise tests after treatment with beta blocker and verapamil and will be     eligible for the study if heart complaints or reduced exercise performance continue.      A pacemaker that treats slow heart rhythms will be inserted. The patient will be sedated and     local anesthesia will be administered to numb the area. The procedure takes about an hour.      The study will last two years. Patients will be placed on one of two pacemaker programs for     the first year and another the second year. At 3- and 6-month follow-up visits, a pacemaker     check and echocardiogram will be performed. After 1 year, patients will be admitted to NIH     for 2 to 3 days for exercise tests, echocardiogram, and cardiac catheterization. Also, the     pacemaker will be changed to the second program. At 15- and 18-month follow-up visits, a     pacemaker check and echocardiogram will be performed. After 2 years, patients will again be     admitted for 2 to 3 days for exercise tests, echocardiogram, and cardiac catheterization. A     pregnancy test will be given to females of child-bearing age before each cardiac     catheterization and electrophysiology study.      At the end of the study, the pacemaker will be set to the program that worked better.      Risks of pacemaker insertion include lung collapse, infection, blood vessel damage, bleeding,     heart attack, and death. Risks of cardiac catheterization include infection, bleeding, blood     clots, abnormal heart rhythms, perforation of the heart, need for surgery, and death.     However, the safety record for both these procedures at NIH has been excellent. The radiation     exposure exceeds the NIH radiation guidelines for children, but this exposure in adults has     not been associated with any definite adverse effects.   "
162716|NCT00001961|"     This study will assess the value of magnetic resonance imaging (MRI) in detecting heart     attack and heart attack risk in patients who come to the hospital emergency room because of     chest pain. It will also investigate whether MRI can help predict the coronary status of     patients 4 to 6 weeks and 1 year after emergency room admission.      Patients who come to the emergency room of Suburban Hospital in Bethesda, MD, because of     chest pain may be asked to enroll in this study if they have not been diagnosed as having a     heart attack. Participating patients will undergo a MRI scan as soon as emergency room     doctors determine they are in stable condition. For this procedure, the patient lies on a     table that slides into the MRI scanner-a large tubular machine with a magnetic field. During     the scan, a contrast material is injected into the vein. This material brightens the image of     the heart so that the blood flow can be seen. The scan will show if there are areas of heart     muscle that received insufficient blood flow. A second scan will be done within 72 hours to     look for coronary artery blockage that may require treatment. Patients will be followed by     telephone 4 to 8 weeks after the scans and again 1 year after the scans to ask about any     significant medical problems that may have occurred during those time periods.      This study will provide information that may improve emergency treatment of patients with     acute chest pain by clarifying which patients require immediate medical treatment, which     should be admitted to the hospital for further evaluation, and which may safely be discharged     from the hospital.   "
162717|NCT00001962|"     Participants in this study are suffering from rare and serious blood disorders. In aplastic     anemia, the bone marrow stops producing red blood cells, platelets, and white blood cells. In     pure red cell aplasia, the bone marrow stops producing red cells, and in amegakaryocytic     thrombocytopenic purpura, the bone marrow stops producing platelets.      Current treatment approaches for these disorders include bone marrow transplant and/or     immunosuppression. However, bone marrow transplant is not always possible, and     immunosuppression has serious side effects.      This study will investigate whether daclizumab can be used to treat these disorders.     Daclizumab is a genetically engineered human antibody that blocks the interleukin-2 receptor     on immune cells. It has been used successfully in many transplant patients to reduce the rate     of organ rejection.      Participants will undergo a complete history and physical examination. A bone marrow     aspiration and biopsy will be performed to confirm the type of bone marrow failure. About 5     tablespoons of blood will be drawn for baseline tests and research purposes. Daclizumab will     be administered every 2 weeks by vein in a 30-minute infusion. The first dose will be given     at NIH and the next four may be given at NIH or by the participant's primary hematologist.     The treatment will last 8 weeks. Participants must also see their referring physician or NIH     physicians every 2 weeks for blood counts. In the fourth and eighth weeks of the study and at     the 3-month follow-up visit, 2 tablespoons of blood will be drawn at NIH. At the 1-month     follow-up visit to NIH, 5 tablespoons of blood will be drawn and another bone marrow     aspiration and biopsy performed.      Risks from bone marrow aspiration and biopsy and blood draws include discomfort. Daclizumab     is usually well-tolerated; however, it may weaken immunity against certain bacteria and     viruses.   "
162718|NCT00001963|"     Nitric oxide (NO) is a soluble gas, continuously synthesized by the endothelium, that     contributes importantly to vasodilator tone of the coronary and systemic circulations by     activating guanylyl cyclase in vascular smooth muscle, causing relaxation. Although regional     synthesis of NO by the endothelium contributes to local vasodilator tone, Stamler and     co-workers have proposed that regional vascular tone may also be regulated by NO transported     from the lungs by hemoglobin as a consequence of enhanced binding of NO to reactive thiols of     oxygenated hemoglobin. This study is designed to determine the contribution of     hemoglobin-transported NO to forearm microvascular dilator tone in healthy subjects at rest     and during regional hypoxia associated with forearm exercise stress, with measurements made     before and after regional blockade of endothelial NO synthesis. Findings in this study may be     relevant to understanding the physiological contribution and therapeutic potential of     hemoglobin-transported NO in the regulation of vasodilator tone in diseases and conditions     associated with regional endothelial dysfunction and reduced endothelial NO bioactivity     (e.g., hypertension, diabetes mellitus, hypercholesterolemia, cigarette smoking, and estrogen     deficiency).   "
162719|NCT00001964|"     This study will test the safety and effectiveness of a combination of three drugs in treating     severe aplastic anemia and preventing its recurrence. Two drugs used in this trial ATG and     cyclosporine are standard combination therapy for aplastic anemia. This study will try to     improve this therapy in three ways: 1) by altering the drug regimen to allow the drugs to     work better; 2) by reducing the risk of kidney damage; and 3) by adding a third drug     mycophenolate mofetil to try to prevent disease relapse.      Patients with severe aplastic anemia who do not have a suitable bone marrow donor or who     decline bone marrow transplantation may participate in this study. Patients will have a skin     test for ATG allergy, chest X-ray, blood test, and bone marrow aspiration before treatment     begins. ATG will then be started, infused through a vein continuously for 4 days. Ten days     after ATG is stopped, cyclosporine treatment will begin, taken twice a day by mouth in either     liquid or capsule form and will continue for 6 months. Also, in the first 2 weeks of     treatment, patients will be given a full dose of corticosteroid (prednisone) to prevent serum     sickness that could develop as a side effect of ATG therapy. The dosage will be decreased     after that. Mycophenolate will be started at the same time as ATG, in two daily doses by     mouth, and will continue for 18 months.      Patients will be hospitalized at the beginning of the study. During this time, blood will be     drawn at 3-week intervals and a bone marrow examination will be repeated 3 months after     treatment has begun. Additional tests, including X-rays may be required. After hospital     discharge, patients will be followed on an outpatient basis at 3-month intervals. The     patients own physician will perform blood tests weekly and kidney and liver function tests     every 2 weeks during cyclosporine therapy. Transfusions may be required initially.   "
162720|NCT00001965|"     This study will examine the effectiveness of the drug cyclosporine in treating hypertrophic     cardiomyopathy (HCM), a condition in which the heart muscle thickens. The thickened muscle     can impair the heart's pumping action or decrease its blood supply, or both. Various     symptoms, such as chest pain, shortness of breath, fatigue, and palpitations, may result. In     animal studies, cyclosporine prevented heart muscle from thickening in mice that had been     engineered to develop thick hearts.      Patients with HCM 18 to 75 years old are screened for this study under protocol 98-H-0102 and     this protocol. Screening tests include blood tests, echocardiogram to measure heart     thickness, Holter monitor to record heartbeats, treadmill exercise test, and various imaging     tests including a thallium scan, radionuclide angiography, magnetic resonance imaging (MRI),     and cardiac catheterization to examine heart function and blood supply.      Patients admitted to the study will be randomly assigned to take either cyclosporine tablets     or a placebo (a look-alike tablet with no active ingredient) twice a day for 6 months. During     a brief hospital stay at the start of the study, blood samples will be taken to measure     cyclosporine levels. After discharge, heart rate and blood pressure will be checked and blood     tests done during follow-up visits once a week for 2 weeks and then every two weeks until the     end of the 6-month treatment period. At that time, patients will be hospitalized a second     time for repeat tests to determine the effects of the drug on the heart condition. They     include thallium scan, radionuclide angiogram, MRI, treadmill exercise test, cardiac     catheterization, and echocardiogram. An echocardiogram and MRI will be repeated 1 year after     the start of the study to evaluate long term effects of the drug, if any.   "
165937|NCT00005754|"     To investigate the occurrence and associated risk factors for subclinical heart disease in     persons with insulin-dependent diabetes mellitus (IDDM).   "
162721|NCT00001966|"     This study will assess the effectiveness of mind-body therapy in relieving pain in patients     with Ehlers-Danlos syndrome. This syndrome is a hereditary condition caused by a connective     tissue defect and is often associated with chronic pain poorly controlled by medication or     physical therapy. Mind-body therapy comprises various complementary or alternative medicine     techniques such as meditation, guided imagery, stress management, and group psychotherapy.      Adult patients with Ehlers-Danlos syndrome who have chronic pain may be eligible for this 4     1/2 [Note: if the symbol is unreadable, it is four and one-half] to 5-month study. Patients     not already enrolled in NHGRI's protocol 97-HG-0089 will undergo a history, physical     examination, and brief interview before being accepted. Participants will attend 2-hour group     sessions of mind-body therapy at NIH each week for at least 10 weeks. They will receive     training in meditation, yoga breathing, guided imagery, and stress management in these     sessions and will be asked to also practice the treatments at home each day. Patients may     continue their regular medications and pain treatment with their private physicians during     the course of the study.      Participants will fill out a packet of questionnaires about their pain, health, and quality     of life at three intervals: when they enroll in the study, at the end of treatment, and 12     weeks after treatment ends. At these same time intervals, patients will come to NIH for a     test of their physical ability to walk and climb stairs. Patients will keep a diary and pain     symptoms and medications for 1 week before treatment begins and 1 week after it ends, and     will fill out questionnaires about pain during the entire study period.   "
162722|NCT00001967|"     Although highly active antiretroviral therapy (HAART) has been successful in suppressing     plasma HIV RNA levels in infected patients, it has not resulted in eradication of virus. It     is now clear that virus replication persists despite undetectable plasma viremia in     individuals receiving HAART. In this regard, withdrawing HAART, even after prolonged periods     of virus suppression, leads to an almost universal rapid rebound of plasma viremia. It is     also now clear that prolonged, continuous HAART carries a risk of significant toxicity and     side effects. These recent observations may argue for a different approach to HAART with the     goals of: 1) durable suppression of virus replication, without an attempt at eradication, and     2) minimization of toxicity and side effects and improvement in patient life-style.     Therefore, we propose to study the virologic and immunologic effects of intermittent versus     continuous HAART in HIV-infected individuals as a possible means to achieve these goals. The     primary protocol, Cohort 1, will be a randomized controlled study of 35 individuals receiving     continuous HAART and 35 individuals receiving intermittent HAART with intervals of one month     off therapy followed by two months on therapy. A second cohort of 10 individuals will serve     as a pilot of 2 arms of 5 patients each to evaluate the potential of shorter on-off cycles to     maintain suppression of plasma virus and boost HIV-specific immune responses. An extension of     Cohort 2 will add 5 patients to the 7 days on/7 days off HAART arm with modified exclusion     criteria and procedure schedule. We will analyze CD4+ T-cell counts, viral load, incidence of     toxicity and side effects, HIV-specific immune responses and viral resistance to therapy and     characterize the virus during rebound plasma viremia.   "
162723|NCT00001968|"     This study will examine the safety of giving antiviral therapy for HIV infection in a     once-daily dosing schedule, and assess how well patients tolerate this regimen. A once a day     dosing schedule may be easier for some people to follow than one that requires taking     medicine 2 or 3 times a day. The ease of treatment is important, because not following the     prescribed dosing regimen may make therapy less effective or ineffective.      HIV-infected patients 18 years and older who have never been treated for their infection may     be eligible for this study. Candidates will be screened with a history and physical     examination, including blood tests. Participants will take the following medications once a     day: 1200 mg of amprenavir (8 capsules); 300 mg of ritonavir (3 capsules); 600 mg of abacavir     (2 pills); and 300 mg of lamivudine (2 pills). Patients will have routine blood tests and be     seen by a nurse or doctor, or both, at follow-up visits at weeks 2, 4, 8, 12, and 16; then     every 8 weeks until week 48; and then every 3 months for up to 3 years. At week 2, a special     blood test will be done over the course of a day to measure blood drug levels. For this test,     blood samples will be drawn 8 times over a 24-hour period. A heparin lock (a device that     allows the needle to remain in the vein) will be used to avoid multiple needle sticks.   "
162724|NCT00001969|"     A series of studies in patients with major depression have consistently demonstrated a     doubling of the mortality rate at any age, independent of suicide. In addition, the relative     risk for clinically significant coronary artery disease in patients with major depression is     also 2 or more in studies that independently controlled for risk factors such as smoking,     hypertension, etc. The principal long-term goals of the CNE include the determination of the     mechanisms that underlie enhanced susceptibility to premature ischemic heart disease in     patients with major depression, documenting the age at which demonstrable pathophysiologic or     predictive changes begin to occur, and charting their rate of progression. Our long-term goal     is to use our understanding of underlying mechanisms to enhance our capacity to predict who     with major depression is most likely to develop premature ischemic heart disease, to     determine what the mechanisms underlying this susceptibility are, and to develop improved     means for treatment and prevention.      Depressed patients are known to manifest a variety of neuroendocrine changes that predispose     to coronary artery disease including hypercortisolism, decreased secretion of growth hormone     and a deficiency of sex steroids. A final common denominator of these neuroendocrine     abnormalities is insulin resistance. Insulin resistance promotes several changes that would     favor hypertension and increased coronary artery disease including increased sodium     retention, increased activity of the sympathetic nervous system, proliferation of vascular     smooth muscle and deposition of highly metabolically active visceral fat. The latter induces     additional risk factors for coronary disease, including dyslipidemia, hypercoagulation, and     enhanced inflammation. It is a matter of public health importance to document the frequency     and severity of insulin resistance in patients with major depression compared to a closely     matched group of healthy controls. To accurately quantify insulin resistance in each patient     and control, we will apply the hyperinsulinemic euglycemic glucose clamp procedure. This is     the gold standard method for measuring the insulin sensitivity since it reflects the direct     human body glucose metabolic response to a known insulin infusion. Moreover, it is essential     to use this technique in patients with major depression as data indicate that other     alternative procedures give unreliable results in the context of hypercortisolism.   "
162755|NCT00002004|"     To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human     CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To assess     pharmacokinetic properties of rCD4 in humans. To obtain a preliminary indication of the     antiviral effects of rCD4 in patients with AIDS and AIDS related complex (ARC).   "
162756|NCT00002005|"     To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human     CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To obtain a     preliminary indication of the antiviral effects of rCD4 in patients with AIDS and ARC. To     measure steady state serum levels of rCD4 following continuous infusion therapy.   "
200835|NCT00478231|"     To collect safety and tolerability data in a more diverse patient population of patients with     HIV/Aids, who have limited therapeutic options.   "
162727|NCT00001973|"     This study will investigate how a gene mutation (change in DNA) causes the abnormal bone in     fibrous dysplasia-a condition in which areas of normal bone are replaced with a fibrous     growth similar to a scar. The bone abnormalities in fibrous dysplasia can occur in a single     bone (monostotic fibrous dysplasia), multiple bones (polyostotic fibrous dysplasia), or in     McCune Albright syndrome, in which there are associated glandular abnormalities. This study     will also examine calcinosis samples that have been surgically removed from patients with     juvenile dermatomyositis.      Patients who are scheduled to have orthopedic surgery for treatment of polyostotic fibrous     dysplasia may participate in this study. A small sample of bone tissue removed during surgery     will be given to investigators in this study for research tests. DNA will be extracted from     the tissue and tested for the mutation. Investigators will attempt to grow cells from the     sample in the laboratory to evaluate them for their ability to grow and make proteins that     normal bone cells make. These tests are designed to help scientists understand how the     mutation leads to abnormal bone formation and provide information that might lead to better     treatments for fibrous dysplasia. Patients with juvenile Dermatomyositis who have a     calcinosis sample surgically removed are also eligible for participation. The removed tissues     will be examined for their composition and microscopic appearance, to better understand the     pathogenesis of dystrophic calcification in this disease.   "
162728|NCT00001975|"     Tuberous sclerosis is a rare, hereditary disease in which patients develop multiple tumors.     Although not cancerous, the tumors can affect various organs, including the heart, lungs,     kidneys, skin, and central nervous system, with serious medical consequences. The severity of     disease varies greatly among patients, from barely detectable to fatal. This study will     investigate what causes skin tumors to develop in patients with this disease.      Patients with tuberous sclerosis 18 years and older may enroll in this study. Participants     will undergo a medical history and thorough skin examination by a dermatologist. Those with     skin tumors will be asked to undergo biopsy (tissue removal) of up to eight lesions, under a     local anesthetic, for research purposes. The biopsies will all be done the same day. The     tissue samples will be used for: examination of genetic changes, measurement of certain     proteins and other substances, and growing in culture to study the genetics of tuberous     sclerosis.   "
162729|NCT00001976|"     This study will evaluate the reliability of a new test called Real-Time Polymerase chain     reaction (RT PCR) in detecting cytomegalovirus (CMV) in the blood and predicting the course     of CMV disease in patients who have recently had a bone marrow transplant. The test's     effectiveness will be compared with that of the pp65 antigenemia assay now routinely used     for this purpose.      CMV is a common virus that is transmitted from person to person by close personal contact. In     most healthy people, CVM can remain in the body indefinitely without causing any harm. But,     in people with weakened immune systems-including those who have just undergone bone marrow     transplant-CMV infection can cause serious, and possibly fatal, complications. Drugs are     available to treat this infection, however. Optimum treatment depends on early and accurate     detection.      Patients aged 10 to 80 years who are scheduled to undergo bone marrow transplant at the NIH     Clinical Center as part of an NIH protocol may be eligible for this 2-phase study. In phase     1, patients will have blood drawn for both RT PCR and antigenemia testing once before the     bone marrow transplantation and then weekly for the first 100 days after the transplant.     During Phase 2-which begins immediately after the end of phase 1 and continues for one year     after the transplant-blood samples for both tests will be drawn up to once a week. The     samples for both tests will be collected at the same time and will be taken through a     catheter (a thin flexible tube inserted into a vein) that has already been placed for the     transplant study. RT PCR testing will require an extra 5 milliliters (1 teaspoon) above what     is needed for antigenemia testing, amounting to a maximum of about one-half pint extra over     the course of the 1-year study.      It is hoped that the new RT PCR test will prove to be more accurate in detecting CMV     infection and predicting disease development, thus enabling doctors to plan early and     effective treatment.   "
162730|NCT00001977|"     This study will examine whether enhancing the chemical acetylcholine in the brain can improve     memory and attention. It will identify changes in brain function that occur during these     cognitive tasks. Animal and human studies have shown that a decrease in acetylcholine may be     responsible for some of the cognition deficits in Alzheimer's disease. Conversely, patients     taking medications that slow the breakdown of this neurotransmitter have experienced     improvements in memory.      Normal volunteers and patients with Alzheimer's disease may be eligible for this study of     functional brain imaging using positron emission tomography (PET) and magnetic resonance     imaging (MRI). These techniques can measure brain activity and identify brain regions     involved in memory and attention. Candidates for this study will be screened with a medical     and psychiatric history and a physical examination including blood tests, urinalysis, chest     X-ray, and electrocardiogram (ECG). Those enrolled will perform memory and attention tasks     during PET and MRI studies. The cognition tasks will be repeated twice-once during infusion     of saline (a fluid with no drug effect) through a catheter inserted into a blood vessel and     again during infusion of physostigmine, a drug that delays the breakdown of acetylcholine.     The PET procedure will be completed in one day; the MRI procedure will be done on two     different days.      During imaging, attention and memory tasks will be presented in short blocks of about     4-minutes duration. They will be repeated in sequence up to 10 times with a few minutes     separation. Subjects will be shown pictures of faces or other visual stimuli and asked to     decide whether the pictures are the same or different.      Information gained from this study may increase knowledge about how acetylcholine affects the     brain's response to memory and attention tasks and perhaps lead to better treatments for the     cognitive deficits in Alzheimer's disease.   "
162731|NCT00001978|"     Much more about kidney disorders can be learned by determining kidney function. This research     proposes to study the kidneys function by several parameters known as glomerular filtration     rate (GFR), Renal Plasma Flow (RPF), and Glomerular Capillary Wall Permselectivity.      The study will select patients suffering from different types of kidney diseases. These     patients will be selected based on the presence of significant amounts of protein in their     urine (proteinuria).      Standard blood and urine tests are often unable to provide completely accurate information     about the kidney. In order for researchers to have a more accurate idea of kidney function,     they will use alternative tests. Test materials (para aminohippurate and inulin) will be     injected into patients veins that provides information based on their filtration through the     kidneys.   "
176039|NCT00144625|"     This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy     and PK of MRA in patients with pJIA who participated in Study MRA318JP.   "
162732|NCT00001979|"     Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis,     membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue     disorders.      This study will allow researchers to admit and follow patients suffering from autoimmune     diseases of the kidney. It will attempt to provide information about the causes and specific     abnormalities associated with autoimmune kidney disease.      Patients with kidney disease as a result of their immune system, and patients with diseases     of the immune system who may later develop kidney disease, will be potential subjects for     this study.      Patients will undergo a history and physical examination, and standard laboratory test to     more closely understand the causes, signs, symptoms, and responses to medication of these     diseases. Based on these evaluations the patients may qualify as candidates for other     experimental studies. At any time these patients may be asked to submit blood or urine     samples for further research.   "
162735|NCT00001983|"     This screening protocol is designed to evaluate patients for participation in clinical     studies in the Gene Therapy and Therapeutics Branch (GTTB) of the National Institute of     Dental and Craniofacial Research. To participate, patients must meet the specific     requirements of at least one of the available research studies; this protocol serves as a     first step for admitting patients to an appropriate program.      People with diagnosed or undiagnosed conditions may participate in this screening protocol.     They will undergo procedures that may include questionnaires, a physical examination, routine     laboratory tests, and diagnostic imaging or radiological studies. Eligibility screening will     be limited to three visits within 12 months of entry into the protocol. If an appropriate     study is not found by the end of this time, the candidate's participation in the screening     program will terminate. No experimental treatments are offered under the screening protocol.      Patients who are found eligible for a current GTTB study will be notified of their options     and invited to enroll.   "
162736|NCT00001984|"     This protocol will test a humanized monoclonal antibody known as Campath-1H for its ability     to induce a state of permanent allograft acceptance, or tolerance, when administered in     combination with a brief course of the immunosuppressive drug deoxyspergualin (DSG) at the     time of human renal allotransplantation. Campath-1H is specific for the common lymphocyte and     monocyte antigen CD52. Its administration temporarily depletes mature lymphocytes and some     monocytes without altering neutrophils or hematopoietic stem cells. Deoxyspergualin inhibits     the NFkB pathway thus preventing monocyte and macrophage activation.      Recipients of living or cadaveric donor kidneys will be treated with one dose of Campath-1H     prior to transplantation to insure that peripheral depletion is achieved at the time of graft     reperfusion. Three subsequent doses of Campath-1H will be administered on the first, third     and fifth days after the transplant to deplete passenger donor leukocytes and residual     recipient cells that mobilize in response to the allograft. In addition, patients will be     treated with DSG for 14 days beginning on the day prior to surgery. This trial expands on     pilot studies at the NIH of 15 patients in which Campath was given alone at the time of     transplantation. In those studies, excellent peripheral depletion occurred after just one     dose of Campath though central depletion required additional dosing. This allowed for greatly     reduced immunosuppression to be used to prevent rejection, but to date, all patients have     required some immunosuppressive medication. It is hoped that the addition of DSG will     eliminate the need for long-term immunosuppression.      Patients will be followed closely in the post transplant period. If patients experience     rejection, they will be treated with methylprednisolone and have immunosuppression added     using sirolimus as the predominant immunosuppressive agent. In the previous phase of this     study without DSG, this maneuver has in all cases been successful in returning the allograft     to normal function.      In addition to evaluating graft function following transplantation, this protocol will also     characterize and evaluate the function of the immune system and the composition of the T cell     repertoire following the administration of Campath-1H and DSG, and during immune system     recovery after transplantation.   "
162737|NCT00001985|"     Type 1 diabetes mellitus is an autoimmune disease in which the body's immune cells attack the     insulin-producing cells of the pancreas. Several environmental and genetic factors may     predispose individuals to developing this disease, including changes in a gene called CD152.     This study will examine how this gene may influence the development of insulin-dependent     diabetes.      Patients with Type 1 diabetes mellitus enrolled in clinical trials at the National Institutes     of Health and at the University of Florida and healthy normal volunteers may participate in     this study. Participants will have up to three blood samples drawn over a period of less than     1 year. The first sample (about 20 milliliters, or 4 teaspoons), will be examined for changes     in the structure of the CD152 gene. If the CD152 structure is different from that normally     seen in the general population, a second sample (about 90 ml, or 6 tablespoons of blood) will     be drawn. This sample will be used to study the function of specialized immune system cells     (T cells), including their growth and survival, chemicals they produce when stimulated, and     other factors. If these cells function differently from what is generally seen in the     population, a third sample (90 ml) will be drawn for more detailed studies.      This investigation may help explain what makes certain individuals susceptible to Type 1     diabetes mellitus and may contribute to the development of improved treatments for the     disease.   "
162757|NCT00002006|"     To assess the safety and efficacy of subcutaneously administered sargramostim (     granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the     neutrophil count in HIV-infected adults who have developed neutropenia as a result of     receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of     subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in     HIV-infected adults with pre-existing neutropenia who are at high risk of developing     hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To     assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history     of HIV infection and associated infectious complications.   "
162783|NCT00002440|"     The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain     protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV     drugs. This study also examines how the body processes these drugs when they are given     together.   "
162738|NCT00001986|"     This study will evaluate the safety and effectiveness of the food additive 1-octanol for     treating essential tremor. This disorder, which is an involuntary shaking, usually of the     hands, has no satisfactory treatment. It affects more than one of every 100 people in the     general population, with the figure climbing to nearly 4 in every hundred among people over     40 years old. In animal studies, 1-octanol reduced chemically induced tremors in rats. This     study will test the effects of the accepted daily intake of 1-octanol (1 milligram per     kilogram of body weight) on essential tremor in humans.      Patients with essential tremor 21 years old and older who wish to enroll in this study will     undergo eligibility screening with a medical history and physical examination that includes     tests for thyroid, liver and kidney problems. Participants will be randomly assigned to     receive either 1-octanol or a placebo (an inactive substance). Patients in both groups will     have an intravenous catheter (a thin, plastic tube) placed in an arm vein for collecting     blood samples during the study. Those in the 1-octanol group will be given a 1-octanol     capsule; the placebo group will receive a look-alike capsule containing no active ingredient.     Neither the patient nor the doctor will know which patients are taking 1-octanol or placebo     until the end of the study.      Tremors will be measured once before the catheter is placed, every 15 minutes during the     first 2 hours after taking the capsule, twice during the third hour (30 minutes apart), and     once again after 5 hours. The tremors are measured using procedures called accelerometry and     surface electromyography. For these procedures, electrodes are taped to the skin; needles are     not used. Blood samples will be collected once before taking the capsule, every 15 minutes     for the first hour and a half after taking the capsule and again at 2 hours, 4 hours and 5     hours after taking the capsule. Vital signs (blood pressure, pulse, and respiratory rate)     will be measured every 15 minutes during the first 2 hours of taking the capsule, every 30     minutes during the third hour, and again at 4 hours and 5 hours.      Participants will stay in the hospital overnight for observation and return after 3 days for     a follow-up physical examination, including a blood test.   "
162796|NCT00002463|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of methotrexate, mechlorethamine,     vincristine, procarbazine, and prednisone in treating children with astrocytomas or primitive     neuroectodermal tumors.   "
162930|NCT00002622|"     RATIONALE: Talc may relieve malignant pleural effusion. It is not yet known whether wet talc     is more effective than dry talc in treating patients with malignant pleural effusion.      PURPOSE: Randomized phase III trial to compare the effectiveness of wet talc with dry talc in     treating patients with malignant pleural effusion.   "
162739|NCT00001987|"     The study will allow researchers to obtain blood, plasma, DNA, and RNA for genetic studies of     insulin. There will be a focus on the causes of insulin resistance and diabetes mellitus.     Insulin is a hormone found in the body that controls the level of sugar in the blood. Insulin     resistance refers to conditions like diabetes when insulin does not work properly. In this     study researchers would like to compare patients with diabetes and other forms of insulin     resistance to normal individuals. The study will investigate how insulin attaches to cells.      Researchers will take 4 to 6 ounces (100-150 ml) of blood from adult patients and may request     up to 12 ounces (one unit) of blood if necessary. Skin samples may be taken for a biopsy if     further genetic testing is necessary. In addition some patients may be asked not to eat for     up to 72 hours prior to testing.   "
162740|NCT00001989|"     This study involves GLQ223 administration to patients who have not previously been exposed to     it, but who have received at least 9 months of zidovudine therapy. Efficacy evaluations will     include survival, opportunistic infections, T4 cell count, and assessments of viral load.   "
162741|NCT00001990|"     To facilitate provision of atovaquone (566C80) to patients who have severe Pneumocystis     carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim /     sulfamethoxazole ( TMX / SMX ); to monitor serious adverse events attributable to 566C80.   "
162742|NCT00001991|"     To facilitate provision of atovaquone (566C80) to patients who have mild to moderate     Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim /     sulfamethoxazole (TMP / SMX ); to monitor serious adverse events attributable to 566C80.   "
162743|NCT00001992|"     To test the safety and immunogenicity of rgp 120/HIV-1IIIB vaccine in HIV-1 seropositive     adult patients.   "
162744|NCT00001993|"     The primary objective of this study is to determine the preliminary efficacy and tolerability     of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic     HIV+ patients with 200 to 500 CD4+ cells/mm3.      The secondary objective is to determine the pharmacokinetics and bioavailability of both     SC-48334 and AZT, when administered together, in symptomatic HIV+ patients with 200 - 500     CD4+ cells/mm3.   "
162745|NCT00001994|"     To evaluate the safety and tolerance of atovaquone (566C80) in AIDS patients with central     nervous system (CNS) toxoplasmosis. To evaluate the efficacy of 566C80 in the acute treatment     and suppression of CNS toxoplasmosis in AIDS patients who fail or who cannot tolerate     conventional therapy.   "
162746|NCT00001995|"     To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of     Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with     MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug     regimen.   "
162747|NCT00001996|"     To compare the safety of atovaquone (566C80) with intravenous (IV) pentamidine for the     treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients who are     intolerant of therapy with trimethoprim / sulfamethoxazole (TMP / SMX) by comparing the     incidence of premature discontinuation of therapy due to toxicity. To compare the efficacy of     566C80 with intravenous (IV) pentamidine for the treatment of mild to moderate PCP in the     same population.   "
162748|NCT00001997|"     To investigate the safety of polyethylene glycolated interleukin-2 (PEG IL-2) given     subcutaneously in conjunction with antiviral treatment and to explore the effects of     treatment on surrogate markers of efficacy and incidence of opportunistic infection and other     clinical markers of HIV disease.   "
162749|NCT00001998|"     To define the pharmacokinetic characteristics of Nystatin LF IV (intravenous) in human     subjects with AIDS-related complex (ARC) after administration of a single IV dose at each of     4 dose levels.   "
162750|NCT00001999|"     To evaluate whether immune globulin and ganciclovir (DHPG) results in faster initial response     as compared to DHPG alone. To evaluate whether immune globulin and DHPG gives longer duration     of remission than DHPG alone (i.e. 16 weeks). To evaluate the toxicities of the combination     of DHPG and immune globulin as compared to those of DHPG alone. To evaluate if there is a     difference between the two groups in regard to survival, immune functions, and CMV viremia     and viruria.   "
162751|NCT00002000|"     To evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir     in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or     equal to 100).   "
162752|NCT00002001|"     To evaluate the virologic effect of combined administration of zidovudine and ddI or ddC. To     evaluate the immunologic effects of zidovudine and ddI or ddC. To evaluate combined     administration of zidovudine and ddI or ddC for clinical efficacy. To evaluate the safety and     the tolerance of the coadministration of zidovudine and ddI or ddC.   "
162753|NCT00002002|"     The primary objective of the study is to evaluate the effectiveness of l-leucovorin in     preventing toxicity from high dose trimethoprim / sulfamethoxazole (TMP / SMX) used as a     therapy for Pneumocystis carinii pneumonia (PCP) in patients with AIDS.   "
162754|NCT00002003|"     To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride (     Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.   "
162789|NCT00002455|"     RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer     cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in     treating patients who have had surgery for breast cancer, colon cancer, or melanoma.      PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as     maintenance immunotherapy following surgery in treating patients with breast cancer, colon     cancer, or melanoma.   "
162790|NCT00002456|"     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were     destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make     an immune response against normal tissues. Methotrexate and cyclosporine may prevent this     from happening.      PURPOSE: Phase III trial to study the effectiveness of treatment with methotrexate and     cyclosporine after bone marrow transplantation to provide protection against acute     graft-versus-host disease.   "
162791|NCT00002458|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating     children with metastatic neuroblastoma in second remission.   "
162797|NCT00002465|"     RATIONALE: Some hormones can stimulate the growth of some types of cancer cells. Hormone     therapy using megestrol may fight cancer by reducing the production of these hormones.      PURPOSE: Phase I/II trial to study the effectiveness of high-dose megestrol in treating     patients with metastatic breast cancer, endometrial cancer, or mesothelioma which cannot be     treated with surgery or radiation therapy.   "
162798|NCT00002466|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug or combining chemotherapy with     radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's     sarcoma, Wilms' tumor, or bone cancer.   "
162799|NCT00002470|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells.     Combining interferon alfa with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of fluorouracil plus interferon alfa in     treating patients who have advanced metastatic carcinoid tumors.   "
162800|NCT00002471|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have acute B-lymphoblastic leukemia or recurrent non-Hodgkin's lymphoma.   "
162801|NCT00002472|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of cisplatin and etoposide in treating     patients with CNS tumors.   "
162802|NCT00002473|"     RATIONALE: Kidney-sparing surgery is a less invasive type of surgery for kidney cancer, and     may have fewer side effects and improve recovery. It is unknown whether kidney-sparing     surgery is more effective than kidney removal in treating kidney cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to completely     remove the kidney with kidney-sparing surgery in treating patients with resectable kidney     cancer.   "
162803|NCT00002474|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, carboplatin, and     mitoxantrone, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving chemotherapy with autologous bone marrow     transplant may allow the doctor to give higher doses of chemotherapy and kill more tumor     cells.      PURPOSE: This phase II trial is studying how well chemotherapy and autologous bone marrow     transplant work in treating patients with refractory or recurrent ovarian cancer.   "
162820|NCT00002494|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and     alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or     acute lymphocytic leukemia.   "
162804|NCT00002475|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Vaccines made from a patient's tumor tissue may make     the body build an immune response to kill tumor cells. Chemotherapy combined with vaccine     therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide with tumor     cell vaccine in treating patients who have metastatic cancer or cancer at high risk of     recurrence.   "
162805|NCT00002476|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known if radiation therapy plus chemotherapy is more effective than     radiation therapy alone in treating patients with advanced head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without chemotherapy in treating patients with advanced head and neck cancer.   "
162806|NCT00002477|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant therapy using     platinum-based chemotherapy drugs with no adjuvant therapy in treating patients with early     stage invasive ovarian epithelial cancer.   "
162807|NCT00002478|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients who have     refractory, recurrent, or metastatic ovarian or cervical cancer.   "
162808|NCT00002479|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of tretinoin in treating patients who have     any stage mycosis fungoides or Sezary syndrome.   "
162809|NCT00002480|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy     may be an effective treatment for prostate cancer.      PURPOSE: Phase I trial to study the effectiveness of radiation therapy in treating patients     who have stage II or stage III prostate cancer.   "
162810|NCT00002481|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Bone marrow transplantation may allow doctors to give higher doses of radiation     therapy and chemotherapy and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose etoposide and     cyclophosphamide plus total-body irradiation followed by bone marrow transplantation in     treating patients who have relapsed or refractory non-Hodgkin's lymphoma.   "
162811|NCT00002482|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody and     cyclophosphamide in treating patients with metastatic cancer.   "
163404|NCT00003505|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with primary central nervous system lymphoma.   "
162812|NCT00002484|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems     that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment     may result in more effective radiation therapy.      PURPOSE: Phase I trial to study the effectiveness of high-dose radiation therapy planned     using a 3-dimensional picture of the tumor in treating patients who have stage I, stage II,     or stage III non-small cell lung cancer.   "
162813|NCT00002485|"     RATIONALE: Taking part in a clinical trial may help children with cancer receive more     effective treatment.      PURPOSE: Determine why patients who are eligible for protocols made available through the     Pediatric Oncology Group do not enroll in them, and develop strategies to increase enrollment     on these clinical trials.   "
162814|NCT00002487|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Dipyridamole may increase the effectiveness of methotrexate and     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining methotrexate and dipyridamole     in treating patients with advanced ovarian cancer that is recurrent after or refractory to     cisplatin-based chemotherapy.   "
162815|NCT00002488|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of     cyclophosphamide, etoposide, and cisplatin in treating patients with intermediate or     high-grade non-Hodgkin's lymphoma who have relapsed following or are resistant to     anthracycline-containing primary combination chemotherapy.   "
162816|NCT00002489|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     children who have non-testicular malignant germ cell tumors.   "
162817|NCT00002490|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not known     whether receiving either radiation therapy, chemotherapy, or observation is more effective     for cancer of the bladder.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy,     chemotherapy, or observation following tumor surgery in treating patients who have bladder     cancer.   "
162818|NCT00002492|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and doxorubicin in     treating patients who have soft tissue sarcoma.   "
162819|NCT00002493|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known which treatment regimen is more effective for endometrial cancer.      PURPOSE: Randomized phase III trial to compare radiation therapy with chemotherapy in     treating patients who have advanced endometrial cancer.   "
167261|NCT00026533|"     RATIONALE: Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the     tumor.      PURPOSE: Phase II trial to study the effectiveness thalidomide in treating patients who have     thyroid cancer.   "
162821|NCT00002495|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor     cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without doxorubicin and vinblastine in treating patients with stage I or stage II Hodgkin's     disease.   "
162822|NCT00002496|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It     is not yet known if chemotherapy plus radiation therapy is more effective than radiation     therapy alone in treating patients with advanced cancer of the larynx.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without chemotherapy in treating patients with advanced cancer of the larynx.   "
162823|NCT00002498|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving drugs in different combinations may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of cyclophosphamide,     methotrexate, and fluorouracil with mitoxantrone in treating older patients with recurrent or     metastatic breast cancer.   "
162824|NCT00002499|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II/III trial to study the effectiveness of combination chemotherapy in     treating children with relapsed acute lymphocytic leukemia.   "
162825|NCT00002501|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide and filgrastim in     treating patients with stage IV, relapsed, or refractory low-grade follicular non-Hodgkin's     lymphoma.   "
162826|NCT00002502|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of     busulfan and cyclophosphamide followed by bone marrow transplantation in treating patients     who have acute or chronic leukemia or myelodysplastic syndrome.   "
162827|NCT00002503|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. This may be an     effective treatment for prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of strontium or radiation     therapy in treating patients with prostate cancer that is refractory to hormone therapy who     have painful bone metastases.   "
164418|NCT00004844|"     OBJECTIVES:      I. Assess the safety and efficacy of embryonic mesencephalic dopamine cell implants into the     putamen of patients with Parkinson's disease.   "
162828|NCT00002504|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill metastatic cancer     cells. Interferon alfa may interfere with the growth of the cancer cells. Combining     interleukin-2 and interferon alfa may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 plus interferon alfa in     treating adults with metastatic cancer.   "
162829|NCT00002505|"     RATIONALE: Vaccines made from the patient's cancer cells may make the body build an immune     response and kill their tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of autologous tumor cell     vaccination plus immunologic adjuvant in treating patients who have metastatic cancer.   "
162830|NCT00002506|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of isotretinoin may be an effective way to     prevent cancer or stop cancer from growing. Interferon alfa may interfere with the growth of     cancer cells. Combining isotretinoin and interferon may be an effective treatment for some     recurrent cancers.      PURPOSE: Phase II trial to study the effectiveness of interferon alfa plus isotretinoin in     treating patients with recurrent cancer.   "
162831|NCT00002507|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether combining mitomycin or porfiromycin with radiation therapy     is more effective in treating patients with head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus     either mitomycin or porfiromycin in treating patients with head and neck cancer.   "
162832|NCT00002508|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may allow doctors to give     higher doses of chemotherapy and kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by     peripheral stem cell transplantation or bone marrow transplantation in treating patients who     have relapsed or recurrent germ cell cancer.   "
162833|NCT00002509|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining peripheral stem cell transplantation with combinations of     drugs may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of high-dose combination chemotherapy     followed by peripheral stem cell transplantation or autologous bone marrow transplantation in     women with stage II breast cancer with eight or more positive axillary lymph nodes and in     women with stage III or metastatic breast cancer.   "
162834|NCT00002510|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Peripheral stem cell transplantation may allow doctors to give higher doses of     chemotherapy and radiation therapy and kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of etoposide plus radiation therapy     followed by peripheral stem cell transplantation in treating patients who have non-Hodgkin's     lymphoma.   "
162835|NCT00002511|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an     effective treatment for prostate cancer.      PURPOSE: Randomized phase III trial to compare radiation therapy with no further treatment in     treating patients with stage III prostate cancer following radical prostatectomy.   "
163188|NCT00002851|"     RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works compared to no further therapy in treating women with stage I, stage II, or stage III     breast cancer that has been surgically removed.   "
162836|NCT00002514|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from     dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous     stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and     kill more cancer cells. It is not yet known whether stem cell transplantation is more     effective than standard chemotherapy in treating acute lymphoblastic leukemia.      PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works     compared to standard combination chemotherapy in treating patients with acute lymphoblastic     leukemia in first remission.   "
162837|NCT00002515|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses     of chemotherapy and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with thiotepa,     carboplatin, and topotecan followed by bone marrow transplantation in treating patients who     have metastatic or progressive rare cancer.   "
162838|NCT00002516|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug with surgery and radiation therapy may kill more tumor cells. It     is not yet known which combination chemotherapy regimen is most effective in treating     patients with Ewing's sarcoma.      PURPOSE: Randomized phase III trial to compare various combination chemotherapy regimens plus     surgery and radiation therapy in treating patients who have Ewing's sarcoma.   "
162839|NCT00002517|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known which regimen of combination chemotherapy is more effective for acute myeloid     leukemia or myelodysplastic syndrome.      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination     chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or     myelodysplastic syndrome.   "
162840|NCT00002519|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor     cells.      PURPOSE: Phase I trial to study the effectiveness of chemotherapy with paclitaxel in     combination with radiation therapy to the chest in patients with previously untreated stage     III non-small cell lung cancer that cannot be surgically removed.   "
163601|NCT00003755|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of Ro 31-7453 in treating patients who have     locally advanced or metastatic solid tumor.   "
162842|NCT00002521|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Bone marrow and peripheral stem cell transplantation may allow     doctors to give high doses of chemotherapy and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with     cyclophosphamide, etoposide and cisplatin followed by bone marrow and/or peripheral stem cell     transplantation in patients with relapsed or refractory intermediate- or high-grade     non-Hodgkin's lymphoma.   "
162843|NCT00002522|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     bone marrow or peripheral stem cell transplantation in treating patients with relapsed or     refractory Hodgkin's lymphoma.   "
162844|NCT00002523|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug, giving the drugs in different ways,     and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with     radiation therapy plus fluorouracil and leucovorin before surgery, with and without     fluorouracil and leucovorin after surgery in patients with rectal cancer that can be     surgically removed.   "
162845|NCT00002524|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients with AIDS-related lymphoma.   "
162846|NCT00002525|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving drugs in different ways may     kill more tumor cells. It is not yet known if surgery is more effective with or without     chemotherapy for colon cancer.      PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU)     chemotherapy after curative resection could improve overall survival and disease-free     survival in patients with Duke's B3 or C colon cancer.   "
162847|NCT00002526|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of     ifosfamide and doxorubicin in patients with advanced sarcoma.   "
162848|NCT00002527|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of aspirin may be an effective way to prevent     the recurrence of polyps in colorectal cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of aspirin in treating     patients who have stage I, stage II, or stage III colorectal cancer that has been surgically     removed.   "
162849|NCT00002528|"     RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast     cancer cells. It is not yet known if surgery to remove breast cancer is more effective with     or without lymph node removal.      PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or     without removal of axillary lymph nodes in treating women who have stage I or stage IIA     breast cancer.   "
168483|NCT00033566|"     RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the     tumor.      PURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have     solid tumors.   "
162850|NCT00002529|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy may     fight breast cancer by blocking the uptake of estrogen. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which     treatment regimen is more effective for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy during or     after combination chemotherapy or hormone therapy alone in treating perimenopausal or     postmenopausal women who have stage II or stage IIIA breast cancer.   "
162851|NCT00002531|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Randomized phase II trial to study the effectiveness of various combination     chemotherapy regimens in treating patients with acute lymphocytic leukemia.   "
162852|NCT00002532|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have relapsed or refractory acute lymphocytic leukemia.   "
162853|NCT00002533|"     RATIONALE: Giving fluconazole may be effective in preventing or controlling mucositis caused     by radiation therapy to the head and neck.      PURPOSE: Randomized phase II/III trial to study the effectiveness of fluconazole in     preventing mucositis in patients undergoing radiation therapy for head and neck cancer.   "
162854|NCT00002534|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of bone marrow     transplantation using untreated or treated bone marrow in treating patients with acute     leukemia in first or second remission.   "
162855|NCT00002535|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     tumor cells from growing. Combining biological therapies with indomethacin and     cyclophosphamide may kill more tumor cells.      PURPOSE: Phase II trial to compare the effectiveness of indomethacin and biological therapy     with or without cyclophosphamide in treating patients who have advanced melanoma that has not     responded to previous therapy.   "
162856|NCT00002536|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so     that it can be removed during surgery.      PURPOSE: Randomized phase III trial to compare surgery with or without chemotherapy in     treating patients who have stage IB cervical cancer.   "
162859|NCT00002539|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of     immune cells found in bone marrow or peripheral blood and may help a person's immune system     recover from the side effects of chemotherapy. It is not yet known whether chemotherapy and     surgery plus G-CSF is more effective than chemotherapy and surgery alone in treating patients     with osteosarcoma.      PURPOSE: Randomized phase III trial to compare the effectiveness combination chemotherapy and     surgery with or without G-CSF in treating patients who have newly diagnosed osteosarcoma.   "
162860|NCT00002540|"     This clinical trial studies whether screening methods used to diagnose cancer of the     prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening     tests may help doctors find cancer cells early and plan better treatment for prostate cancer.   "
162861|NCT00002542|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses     different ways to stop tumor cells from dividing so they stop growing or die.      PURPOSE: Phase III trial to study the effectiveness of tamoxifen following surgery and     chemotherapy in treating women who have stage I breast cancer at high risk of recurrence or     stage II or stage III breast cancer.   "
162862|NCT00002543|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: : Phase I trial to study the effectiveness of gallium nitrate in young patients who     have malignant brain tumors, neuroblastoma, rhabdomyosarcoma, non-Hodgkin's lymphoma, or     refractory solid tumor.   "
162863|NCT00002544|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if mitoxantrone is more effective with or     without docetaxel.      PURPOSE: Randomized phase III trial to compare the effectiveness of mitoxantrone with or     without docetaxel in treating women who have metastatic breast cancer with a poor prognosis.   "
162864|NCT00002545|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy uses     different ways to stop tumor cells from dividing so they stop growing or die. Combining     radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy and     carmustine in treating patients who have supratentorial glioblastoma multiforme.   "
162865|NCT00002546|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether radiation therapy is more effective than combination     chemotherapy in treating patients with cancer of the uterus.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works compared to combination chemotherapy in treating patients with cancer of the uterus.   "
162866|NCT00002547|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may     allow the doctor to give higher doses of chemotherapy and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation following     combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic     syndrome .   "
162867|NCT00002548|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy and radiation therapy and kill more     cancer cells. It is not yet known which treatment regimen is more effective for multiple     myeloma.      PURPOSE: Randomized phase III trial to compare the effectiveness of melphalan, total-body     irradiation, and peripheral stem cell transplantation with that of combination chemotherapy     in treating patients who have previously untreated multiple myeloma.   "
162868|NCT00002549|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     followed by bone marrow or peripheral stem cell transplantation in treating patients with     acute myelogenous leukemia.   "
162869|NCT00002550|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor     cells. It is not yet known if chemotherapy plus radiation therapy is more effective with or     without surgery for lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combining cisplatin,     etoposide, and radiation therapy with or without surgery in treating patients who have stage     IIIA non-small cell lung cancer.   "
162870|NCT00002551|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It     is not yet known which treatment regimen is more effective for rectal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of     combination chemotherapy plus radiation therapy in treating patients who have rectal cancer     that has been surgically removed.   "
162871|NCT00002552|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining bone marrow transplantation with chemotherapy may allow     doctors to give higher doses of chemotherapy and kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving a bone marrow transplant     together with chemotherapy and to see how well it works in treating patients with refractory     non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.   "
162872|NCT00002553|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Bone marrow transplantation may be able to replace immune cells that were destroyed by     chemotherapy or radiation therapy used to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation using     unrelated bone marrow donors in treating patients who have hematologic cancer.   "
162873|NCT00002554|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Monoclonal antibody combined     with a radioactive substance and given prior to bone marrow transplantation may kill more     cancer cells.      PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody given     prior to bone marrow transplantation in treating patients with acute myelogenous leukemia.   "
162874|NCT00002555|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known if radiation therapy plus chemotherapy is more effective than     radiation therapy alone in treating patients with head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation     therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head     and neck cancer who have undergone surgery to remove the cancer.   "
162875|NCT00002556|"     This randomized phase III clinical trial studies combination chemotherapy with high dose     cyclophosphamide and recombinant interferon alfa-2b to see how well it works compared to     combination chemotherapy alone in treating patients with previously untreated stage I-III     multiple myeloma. Drugs used in chemotherapy, such as vincristine sulfate, carmustine,     melphalan, cyclophosphamide, and prednisone, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Recombinant     interferon alfa-2b may interfere with the growth of cancer cells. It is not yet know whether     giving combination chemotherapy with or without alternating high-dose cyclophosphamide and     recombinant interferon alfa-2b is more effective in treating multiple myeloma.   "
162876|NCT00002557|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of etoposide with or without doxorubicin     and methotrexate in treating patients who have mycosis fungoides.   "
162877|NCT00002558|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, carboplatin, and     etoposide work in different ways to stop the growth of tumor cells, either by killing them or     by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant     may allow more chemotherapy to be given so that more tumor cells are killed.      The design of this trial is a phase I/II trial of sequential accelerated chemotherapy cycles     with taxol/ifosfamide and carboplatin/etoposide administered with G-CSF and PBSC support.      PURPOSE: The purpose of this study is to determine the effects of an intensive sequence of     chemotherapy drugs in patients with metastatic germ cell cancer. All of these chemotherapy     drugs are known to be active in this disease.   "
163239|NCT00002915|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of penclomedine in treating patients who     have advanced solid tumors.   "
162878|NCT00002559|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting     of paclitaxel, cisplatin, and ifosfamide in treating patients who have ovarian or testicular     germ cell tumors that are refractory to platinum-containing chemotherapy.   "
162879|NCT00002560|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Combining colony-stimulating     factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for     advanced neuroblastoma.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus     sargramostim in treating patients who have advanced neuroblastoma.   "
162880|NCT00002561|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells.     Combining more than one drug or combining chemotherapy with radiation therapy may kill more     tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with     or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage     IIA Hodgkin's disease.   "
162881|NCT00002562|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with     advanced, refractory, or recurrent cervical or vaginal cancer.   "
162882|NCT00002563|"     RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help     determine the intermediate- and long-term effects of treatment on patients with cancer.      PURPOSE: This clinical trial studies the impact of therapy on the health status and quality     of life of patients with stage I or stage II Hodgkin's disease who are receiving radiation     therapy with or without chemotherapy.   "
162883|NCT00002564|"     RATIONALE: Dietary fat may be involved in the growth of cancer cells. Restricting dietary fat     may help fight cancer.      PURPOSE: Randomized clinical trial to study the effectiveness of a low fat diet in treating     postmenopausal women who have stage I, stage II, or stage IIIA breast cancer that has been     completely removed by surgery.   "
162884|NCT00002565|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known which combination chemotherapy regimen is more effective for intermediate-grade     or immunoblastic non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination     chemotherapy regimens in treating patients who have intermediate-grade or immunoblastic     non-Hodgkin's lymphoma.   "
162885|NCT00002566|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not known whether combining chemotherapy with bone marrow     transplantation is a more effective treatment for men with germ cell tumors.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with bone marrow transplantation in treating men with relapsed germ cell tumors.   "
164419|NCT00004845|"     The primary specific aim of this clinical trial is to determine whether treatment with     rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in     patients with Alzheimer's disease (AD) as measured by ADAScog.   "
162886|NCT00002567|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose radiation therapy and     etoposide followed by peripheral stem cell transplantation in treating patients with acute     leukemia.   "
162887|NCT00002568|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug or combining chemotherapy with surgery     may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     consisting of paclitaxel and cisplatin with or without surgery in treating patients with     stage III ovarian epithelial cancer.   "
162888|NCT00002569|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without chemotherapy in treating patients who have anaplastic oligodendroglioma.   "
162889|NCT00002570|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which treatment regimen is more effective for colorectal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of immediate with delayed     fluorouracil plus leucovorin in treating patients with advanced colorectal cancer without     signs or symptoms of disease.   "
162890|NCT00002571|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Antiviral therapy may be effective treatment for AIDS-related lymphoma.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation     therapy, and antiviral therapy in treating patients who have AIDS-related lymphoma.   "
162891|NCT00002572|"     RATIONALE: Biological therapy uses different ways to stimulate the immune system and stop     cancer cells from growing. Cytotoxic T cells combined with interleukin-2 may be an effective     treatment for recurrent brain tumors.      PURPOSE: Phase I trial to study the effectiveness of cytotoxic T cells and interleukin-2 in     treating adults with recurrent brain tumors.   "
162892|NCT00002574|"     Phase II trial to study the effectiveness of homoharringtonine and interferon alfa in     treating patients with chronic myelogenous leukemia. Drugs used in chemotherapy use different     ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may     interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may     kill more cancer cells.   "
162893|NCT00002575|"     RATIONALE: Less invasive types of surgery may help reduce the number of side effects and     improve recovery. It is not yet known which type of surgery is more effective for colon     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted     colectomy with open colectomy in treating patients who have colon cancer.   "
162894|NCT00002576|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     consisting of cyclophosphamide, vincristine, and prednisolone, with either mitoxantrone or     doxorubicin in treating patients with intermediate- or high-grade non-Hodgkin's lymphoma.   "
162895|NCT00002577|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating     patients with non-small cell lung cancer that cannot be surgically removed.   "
162896|NCT00002578|"     RATIONALE: Chemotherapy uses different ways to stop cancer cells from dividing so they stop     growing or die.      PURPOSE: Phase II trial to study the effectiveness of gallium nitrate in treating patients     with AIDS-related non-Hodgkin's lymphoma.   "
162897|NCT00002579|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining combination     chemotherapy with hormone therapy may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without tamoxifen in treating women with stage I or stage II breast cancer that can     be surgically removed.   "
162898|NCT00002580|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses     different ways to stop tumor cells from dividing so they stop growing or die. Combining     chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which     treatment regimen is most effective for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with that of     ovarian ablation, and/or combination chemotherapy in treating premenopausal women with stage     I, stage II, or stage IIIA breast cancer.   "
162899|NCT00002581|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining combination     chemotherapy with hormone therapy may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without     combination chemotherapy in treating postmenopausal women with stage I or stage II breast     cancer that can be surgically removed.   "
162900|NCT00002582|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination     chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or     die. Combining hormone therapy with chemotherapy may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without     chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA     breast cancer.   "
163085|NCT00002722|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving higher doses may kill more     tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of high-dose chemotherapy in     treating patients with advanced stomach cancer.   "
162901|NCT00002583|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if combination chemotherapy is more effective     than no further treatment for non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine plus     cisplatin with that of no further therapy in treating patients who have stage I or stage II     non-small cell lung cancer that has been completely removed during surgery.   "
162902|NCT00002585|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating women with     metastatic breast cancer.   "
162903|NCT00002586|"     RATIONALE: 13 Cis retinoic acid may prevent the development of cancer cells.      PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of 13-cis     retinoic acid with or without vitamin E for chemoprevention or observation of cancer in     persons at high risk of developing lung cancer.   "
162904|NCT00002587|"     Phase I trial to study the effectiveness of paclitaxel plus topotecan in treating patients     who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.   "
162905|NCT00002588|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of topotecan and etoposide in treating     patients who have recurrent or refractory leukemia.   "
162906|NCT00002589|"     RATIONALE: Treating a person's lymphocytes with interleukin-2 and monoclonal antibody may     help them kill more cancer cells when they are put back in the body.      PURPOSE: This phase II trial is studying how well lymphocyte therapy works in treating     patients with stage III or stage IV kidney cancer.   "
162907|NCT00002590|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     children who have lymphoma.   "
162908|NCT00002592|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by autologous     bone marrow transplantation in treating patients with chronic myelogenous leukemia.   "
162909|NCT00002593|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving drugs in different ways may     kill more cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given in     different ways in treating patients with surgically removed stage II or stage III colon     cancer at high risk of recurrence.   "
162923|NCT00002611|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. It     is not yet known whether combination chemotherapy alone or combination chemotherapy plus     radiation therapy is more effective for childhood kidney cancer.      PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy with or     without radiation therapy in treating children who have kidney cancer.   "
162910|NCT00002594|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     that they stop growing or die. bone marrow transplantation and peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     bone marrow transplantation and/or peripheral stem cell transplantation in treating patients     who have recurrent medulloblastoma or CNS germ cell tumors.   "
162911|NCT00002595|"     RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using     toremifene may fight the growth of desmoid tumors by reducing the production of estrogen.      PURPOSE: Phase II trial to study the effectiveness of toremifene in treating patients with     desmoid tumors.   "
162912|NCT00002596|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not known whether combining chemotherapy with bone marrow or     peripheral stem cell transplantation is more effective than combination chemotherapy alone in     treating men with germ cell tumors.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without bone marrow or peripheral stem cell transplantation in treating men with     previously untreated germ cell tumors.   "
162913|NCT00002597|"     RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens     can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide,     goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens.     It is not yet known which regimen of antiandrogen therapy is most effective for prostate     cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or     without antiandrogen therapy in treating patients who have stage I or stage II prostate     cancer.   "
162914|NCT00002598|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.     Interferon alfa may interfere with the growth of cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and interferon     alfa in treating patients with chronic myelogenous leukemia.   "
162931|NCT00002623|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so     that it can be removed during surgery. Radiation therapy uses high-energy x-rays to damage     tumor cells. It is not yet known whether chemotherapy followed by surgery with or without     radiation therapy is more effective than chemotherapy followed by radiation therapy alone in     treating non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by     surgery with or without radiation therapy to that of chemotherapy followed by radiation     therapy alone in treating patients who have stage III non-small cell lung cancer.   "
162915|NCT00002599|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with     chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more     cancer cells. Interferon alfa may interfere with the growth of cancer cells. It is not yet     known whether a more intensive chemotherapy regimen plus stem cell or bone marrow transplant     is more effective than standard chemotherapy in treating patients with myeloma.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of     combination chemotherapy plus interferon alfa with or without high dose melphalan or bone     marrow or peripheral stem cell transplantation in treating patients with previously untreated     myeloma.   "
162916|NCT00002600|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Bone marrow transplantation and peripheral stem cell     transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor     cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with     carboplatin and cyclophosphamide followed by bone marrow and peripheral stem cell     transplantation in treating patients who have advanced ovarian epithelial cancer.   "
162917|NCT00002601|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and combining chemotherapy with     peripheral stem cell transplantation may allow the doctor to give higher doses of     chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy and     peripheral stem cell transplantation in treating patients who have advanced or recurrent     sarcoma.   "
162918|NCT00002602|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an     effective treatment for prostate cancer.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating     patients who have previously untreated stage II or stage III prostate cancer.   "
162919|NCT00002604|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of O(6)-benzylguanine and carmustine in     treating patients who have solid tumors.   "
162920|NCT00002608|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and doxorubicin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Estrogen can stimulate     the growth of tumor cells. Hormone therapy using tamoxifen may fight cancer by blocking the     uptake of estrogen. Combining tamoxifen with chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cisplatin and doxorubicin together     with tamoxifen works in treating patients with solid tumors.   "
162921|NCT00002609|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     tumor-killing substances to them, without harming normal cells. Drugs used in chemotherapy     use different ways to stop cancer cells from dividing so they stop growing or die. Combining     chemotherapy with monoclonal antibody therapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus monoclonal antibody     therapy in treating patients with acute promyelocytic leukemia in remission.   "
162922|NCT00002610|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give     higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which     therapy regimen is most effective for treating patients with kidney tumors.      PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without     radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in     treating young patients with kidney tumors.   "
163065|NCT00002692|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous infusion or     intrahepatic infusion of fluorouracil and leucovorin in treating patients with colorectal     cancer metastatic to the liver.   "
162924|NCT00002615|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     known whether receiving chemotherapy before surgery may be more effective than surgery alone     in treating patients with stomach cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination     chemotherapy with surgery alone in treating patients with stomach cancer.   "
162925|NCT00002616|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Peripheral stem cell transplantation combined with biological     therapy may be an effective treatment for breast cancer.      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 with filgrastim to     stimulate cell production in treating patients with stage IIIB, stage IV, metastatic, or     recurrent breast cancer who will undergo peripheral stem cell transplantation.   "
162926|NCT00002618|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Giving the drugs in different doses may kill more cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various     combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.   "
162927|NCT00002619|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Bone marrow or peripheral stem cell transplantation may be able to     replace immune cells that were destroyed by chemotherapy used to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by autologous     bone marrow or peripheral stem cell transplantation in treating patients with glioblastoma     multiforme or brain stem tumors.   "
162928|NCT00002620|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an     effective treatment for patients with anaplastic astrocytomas.      PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in     treating patients with anaplastic astrocytomas.   "
162932|NCT00002624|"     RATIONALE: Video-assisted surgery followed by radiation therapy may be an effective treatment     in patients whose poor heart and lung function make them high risk for standard surgery.      PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery followed by     radiation therapy in treating patients with stage I non-small cell lung cancer and poor heart     and lung function.   "
162933|NCT00002625|"     Phase I trial to study the effectiveness of topotecan and radiation therapy in treating     patients who have solid tumors or lymphoma. Drugs used in chemotherapy use different ways to     stop cancer cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may     kill more cancer cells.   "
162934|NCT00002627|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune     cells that were destroyed by chemotherapy used to kill tumor cells, allowing higher doses of     chemotherapy to be used.      PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel when added to high-dose     combination chemotherapy followed by peripheral stem cell transplantation in treating women     with breast cancer at high risk of relapse.   "
162935|NCT00002628|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Peripheral     stem cell transplantation may be able to replace immune cells that were destroyed by     chemotherapy used to kill tumor cells, allowing higher doses of chemotherapy to be used.      PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel added to a regimen of     high-dose chemotherapy with cyclophosphamide and carboplatin followed by peripheral stem cell     transplantation in treating women with metastatic breast cancer.   "
162936|NCT00002630|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining peripheral stem cell transplantation with chemotherapy and radiation therapy may     allow the doctor to give higher doses of radiation and chemotherapy drugs and kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan plus total-body     irradiation and peripheral stem cell transplantation in treating patients with multiple     myeloma in first relapse.   "
162937|NCT00002631|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It     is not known whether high-dose radiation therapy is more effective than standard dose     radiation therapy in treating cancer of the esophagus.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     plus high- or standard-dose radiation therapy in treating patients with cancer of the     esophagus.   "
162938|NCT00002632|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with     metastatic or recurrent salivary gland cancer.   "
162939|NCT00002633|"     RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may     fight prostate cancer by reducing the production of androgens. Radiation therapy uses     high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus     surgery is more effective than hormone therapy plus radiation therapy for prostate cancer.      PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how     well it works compared to giving hormone therapy together with bilateral orchiectomy or     radiation therapy in treating patients with stage III or stage IV prostate cancer.   "
162940|NCT00002634|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow     the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation     therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies can locate tumor     cells and either kill them or deliver tumor-killing substances to them without harming normal     cells.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy, radiation     therapy, immunotherapy, and bone marrow transplantation in treating patients with     neuroblastoma.   "
162941|NCT00002635|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients     with advanced cutaneous T-cell lymphoma.   "
162942|NCT00002637|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells including natural killer     cells to kill prostate cancer cells. Interferon gamma may interfere with the growth of the     cancer cells. Combining interferon gamma with interleukin-2 may be a more effective treatment     for prostate cancer.      PURPOSE: Phase I/II trial to study the effectiveness of biological therapy using     interleukin-2 and interferon gamma in treating patients with advanced prostate cancer.   "
162943|NCT00002638|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     peripheral stem cell transplantation in treating children who have relapsed acute lymphocytic     leukemia.   "
162944|NCT00002639|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with     recurrent primary brain tumors following radiation therapy.   "
162945|NCT00002641|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether giving chemotherapy after surgery is     more effective than surgery alone in treating soft tissue sarcoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without     chemotherapy in treating patients who have soft tissue sarcoma.   "
163206|NCT00002876|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients with recurrent ependymomas following radiation therapy.   "
162946|NCT00002642|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to kill tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy using cisplatin and     etoposide, radiation therapy, and surgery, with adjuvant therapy using cisplatin and     etoposide, in treating patients who have stage III non-small cell lung cancer.   "
162947|NCT00002643|"     Phase II trial to study the effectiveness of combination chemotherapy in treating patients     with newly diagnosed metastatic Ewing's sarcoma or primitive neuroectodermal tumor. Drugs     used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining more than one drug may kill more tumor cells.   "
162948|NCT00002644|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by blocking the uptake of estrogen.      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of tamoxifen     with a placebo in preventing breast cancer in women at high risk.   "
162949|NCT00002646|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining chemotherapy     with hormone therapy may kill more tumor cells. Chemoprevention therapy is the use of certain     drugs to try to prevent the development or recurrence of cancer. The use of fenretinide may     be an effective way to prevent the recurrence of breast cancer. It is not yet known whether     tamoxifen plus fenretinide is more effective than tamoxifen alone for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen plus     fenretinide with tamoxifen alone in treating postmenopausal women who have stage II or stage     III breast cancer that is estrogen receptor positive and/or progesterone receptor positive.   "
162950|NCT00002647|"     RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and     may be an effective treatment for refractory brain tumors.      PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic     therapy using porfimer sodium in treating patients with refractory brain tumors, including     astrocytoma, ependymoma, and medulloblastoma.   "
162951|NCT00002649|"     Randomized phase III trial to compare the effectiveness of interleukin-2 with that of     observation following radiation therapy, combination chemotherapy, and peripheral stem cell     transplantation in treating patients who have refractory or relapsed non-Hodgkin's lymphoma.     Interleukin-2 may stimulate a person's white blood cells to kill non-Hodgkin's lymphoma     cells. Giving interleukin-2 after radiation therapy, chemotherapy, and peripheral stem cell     transplantation may kill more cancer cells   "
162952|NCT00002650|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of folic acid may be an effective way to prevent     colorectal cancer in patients with polyps that have been surgically removed.      PURPOSE: Randomized phase II trial to study the effectiveness of high-dose folic acid in     preventing colorectal cancer in patients who have had polyps surgically removed within 18     months of the trial.   "
163416|NCT00003520|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have stage IV kidney cancer.   "
162953|NCT00002651|"     RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy     may be effective treatment for prostate cancer. It is not yet known which regimen of hormone     therapy is most effective for stage IV prostate cancer.      PURPOSE: This randomized phase III trial is studying two different regimens of hormone     therapy and comparing how well they work in treating men with stage IV prostate cancer.   "
162954|NCT00002652|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients who have     refractory or relapsed multiple myeloma or Castleman's disease.   "
162955|NCT00002653|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is most effective in treating older patients     with multiple myeloma.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without cyclophosphamide and prednisone in treating older patients with multiple     myeloma.   "
162956|NCT00002654|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known if radiation therapy plus chemotherapy is more effective than     radiation therapy alone in treating patients with advanced head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus     cisplatin with radiation therapy alone in treating patients with advanced head and neck     cancer.   "
162957|NCT00002655|"     RATIONALE: Cryosurgery kills cancer cells by freezing them during surgery.      PURPOSE: Phase I/II trial to study the effectiveness of cryosurgery in treating patients with     unresectable primary liver cancer or liver metastases.   "
162958|NCT00002656|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy with pyrazoloacridine in     treating patients with stage IIIB or stage IV non-small cell lung cancer.   "
162959|NCT00002657|"     RATIONALE: Reducing the amount of drugs used to prevent transplant rejection may help a     person's body kill tumor cells. Giving biological therapy, such as interferon alfa, which may     interfere with the growth of cancer cells, or combination chemotherapy, which uses different     ways to stop tumor cells from dividing so they stop growing or die, may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of reducing immunosuppression, and giving     interferon alfa and combination chemotherapy, in treating patients who have malignant tumors     that develop after organ transplant.   "
163244|NCT00002921|"     RATIONALE: Some tumors need growth factors produced by the body to keep growing. Suramin may     interfere with the growth factor and stop the tumor from growing.      PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with stage     III or stage IV adrenocortical cancer.   "
162960|NCT00002658|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Biological therapies use different ways to stimulate the immune     system and stop cancer cells from growing. Combining chemotherapy with bone marrow     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of different treatment     regimens in treating patients who have acute myeloid leukemia.   "
162961|NCT00002659|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known if treatment with cisplatin plus epinephrine is effective for head and neck cancer.      PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of     cisplatin plus epinephrine in injectable gel form in treating patients who have recurrent or     refractory head and neck cancer.   "
162962|NCT00002662|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether paclitaxel is more effective than     docetaxel for breast cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in     treating women with stage IIIB or metastatic breast cancer.   "
162963|NCT00002663|"     The purpose of this phase I/II trial is to study the side effects and best dose of biological     therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or     lymphoproliferative disease.   "
162964|NCT00002664|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Colony-stimulating factors     such as G-CSF may increase the number of immune cells found in bone marrow or peripheral     blood, and may help a person's immune system kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus G-CSF     in treating patients with metastatic colorectal cancer that has not responded to treatment     with fluorouracil.   "
162965|NCT00002665|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or     without bone marrow transplantation in treating patients who have acute lymphocytic leukemia.   "
162966|NCT00002667|"     RATIONALE: Using new methods to examine sputum samples for the presence of cancer cells may     detect lung cancer earlier.      PURPOSE: Screening trial to study the effectiveness of new methods of examining sputum     samples to detect second primary lung cancer in patients with resected stage I non-small cell     lung cancer.   "
162967|NCT00002668|"     RATIONALE: An outpatient educational and behavioral skills training program may help patients     with metastatic breast or prostate cancer live longer and more comfortably.      PURPOSE: This randomized clinical trial studies whether an outpatient educational and     behavioral skills training program will improve pain control in patients who have metastatic     or recurrent breast or prostate cancer.   "
162968|NCT00002669|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells.     Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not     yet known which treatment regimen is more effective in treating melanoma.      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of     combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have     metastatic melanoma.   "
162969|NCT00002670|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether radiation therapy plus cisplatin is more effective than     radiation therapy alone in treating patients with head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus     cisplatin with radiation therapy alone in treating patients with head and neck cancer that     has been removed during surgery.   "
162970|NCT00002671|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients     with recurrent or unresectable epithelial ovarian cancer that has been previously treated     with platinum-based chemotherapy.   "
162971|NCT00002673|"     RATIONALE: White blood cells from donors who have been exposed to cytomegalovirus may be able     to help prevent this infection from occurring in patients who are undergoing bone marrow or     peripheral stem cell transplantation.      PURPOSE: Phase II trial to study the effectiveness of donated white blood cells to prevent     cytomegalovirus infection in patients who are undergoing bone marrow or peripheral stem cell     transplantation.   "
162972|NCT00002674|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Bone marrow transplantation may be able to replace immune cells     that were destroyed by chemotherapy used to kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     G-CSF and peripheral stem cell transplantation in treating patients with chronic myelogenous     leukemia.   "
162973|NCT00002675|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients with retinoblastoma.   "
162974|NCT00002676|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells and may be an     effective treatment for non-Hodgkin's lymphoma.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and     whole-brain radiation therapy in patients with primary central nervous system non-Hodgkin's     lymphoma.   "
163245|NCT00002922|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with     recurrent or metastatic head and neck cancer.   "
162975|NCT00001652|"     The purpose of this research protocol is to screen and enroll individuals who have bipolar     disorder and to track each person's course of illness in order to study the long-term course     of illness and to elucidate possible clinical and biological predictors of acute and     sustained treatment response. As a part of this protocol, subjects will: systematically be     administered psychiatric rating scales such as the life-chart method (LCM) for daily     assessment of mood, sleep, and behavior; be asked to participate in non-invasive research     procedures, such as blood drawing for measurement of thyroid antibodies and intracellular     calcium; and be medicated as is clinically appropriate. This protocol also serves as a     stepping stone to other protocols such as the comparative acute and long-term efficacy of     three antidepressants (#95-M-0129), and the efficacy of omega-3 fatty acids (#00-M-0004), for     which separate written informed consents are obtained. Patients in this study are     participants in the larger NIMH-Stanley Foundation Bipolar Network (SFBN), which involves six     academic sites focused on better understanding the long-term course and treatment of the     illness. The current protocol thus serves as an entry point for individuals with bipolar     disorder for screening and detailed longitudinal assessment both prior to and in between more     formal blind randomized IRB approved treatment protocols.   "
162976|NCT00001654|"     The dysregulated experience and expression of emotion is implicated in psychiatric disorders     associated both with externalizing problems (aggressive, antisocial behaviors) and     internalizing problems (anxiety, depression). Adolescence is a critical juncture in the     development of these disorders because of the increased incidence and differentiation of     clinical problems during this time period. This is a biobehavioral, longitudinal     investigation of the role of emotion in the development of psychopathology in adolescence.     The focus is on socialization experiences and biological processes that contribute to emotion     dysregulation and disorder in male and female youths between 11 and 16 years of age. Groups     studied include (1) comorbid externalizers and internalizers, (2) externalizers only, (3)     internalizers only, and (4) asymptomatic youth. The adolescents are assessed again two years     later, with instruments and paradigms similar to those used at Time 1. One theme pertains to     the integration and disconnection of emotions across systems (e.g., physiological and     self-report of experience), and how different patterns of emotion relate to psychopathology.     A second theme pertains to development changes in how disorders are manifested (e.g.,     increased differentiation along gender specific pathways). The anticipated number of patient     days per year is 240 for adolescents and mothers, and 120 days for fathers.   "
162977|NCT00001656|"     The purpose of this study is to compare the effectiveness and side effects of the drugs     clozapine and olanzapine in children and adolescents with schizophrenia and psychoses.      Childhood psychosis is a serious disorder that may have devastating consequences. Effective     treatments for the condition are under continual investigation. This study will examine the     causes of and offer treatment for childhood psychosis.      Participants in this study will undergo psychological tests, blood and urine tests,     electroencephalogram (EEG), electrocardiogram (EKG), and magnetic resonance imaging (MRI)     scans of the brain for the first 1 to 2 weeks of the study while taking their regular     medications. Participants will then be tapered off their medications over 1 to 3 weeks and     will continue to stay off medications for an additional 2 days to 3 weeks. During this time,     participants will undergo psychiatric, neurological, and cardiac examinations as well as     blood tests. After this period without medications, participants will be randomly assigned to     receive either clozapine or olanzapine for 8 weeks. An EEG will be performed prior to     treatment and after 6 weeks of study medication. Participants who respond well to the study     drugs may continue to receive them through their own physician. Participants who do not     respond to either clozapine or olanzapine or cannot tolerate their side effects will be     treated individually with other drugs until optimum treatment is identified. Regular     telephone updates and in person visits to NIH for repeat testing and MRIs will be conducted.   "
162978|NCT00001657|"     Posttraumatic stress disorder occurs in patients who have experienced, witnessed or have been     confronted with an event involving actual death or the threat of death, serious injury, or     the threat to physical health and felt fear, helplessness, or horror. As a result, patients     continue to re-experience, recollect, dream, or have flashbacks about the traumatic incident.      Research on PTSD continues to show metabolic changes in specific areas of the brain in     patients diagnosed with PTSD. For example, neuroimaging studies (functional MRI and PET     scans) reveal that blood flow and glucose utilization increases in the right frontal, limbic,     and paralimbic areas of the brain in patients with PTSD, particularly when they are recalling     the traumatic event associated with their symptoms.      One potential method for interfering with the neuronal circuitry associated with traumatic     memories is through the use of repetitive transcranial magnetic stimulation (rTMS). This     technique involves the placement of a cooled electromagnet with a figure-eight coil on the     patient's scalp and rapidly turning on and off the magnetic flux. This permits non-invasive,     relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of     magnetic stimulation varies, depending upon the location, intensity and frequency of the     magnetic pulses. Preliminary clinical data shows that low frequency rTMS stimulation leads to     a decrease in regional cerebral blood flow.      This study is designed to determine if rTMS stimulation in patients diagnosed with PTSD leads     to symptomatic improvement, reductions in blood flow to specific areas of the brain, and     improvements in the regulation of the autonomic nervous system.   "
162979|NCT00001658|"     Bacteria carry substances on their surface called antigens. When antigens come into contact     with the right kinds of cells in the body an immune reaction is caused. This reaction is     often the symptoms of sickness that a patient feels.      In order for the body to fight off the attack of antigens, it creates substances called     antibodies. Antibodies counter the action of antigens and make the bacteria harmless.     However, the immune system must learn how to make the right antibodies for the right     antigens. Sometimes the body creates antibodies that confuse normal tissues as foreign and     attack them. This is called an autoimmune reaction and sometimes occurs when the body is     exposed to certain bacteria.      One bacteria known for causing autoimmune reactions is Group A beta-hemolytic Streptococcus     (GABHS). This bacteria often causes throat infections commonly known as strep throat. Some     researchers believe that the autoimmune reaction associated with strep throat infections may     cause neuropsychiatric disorders, like obsessive-compulsive disorder and/or tic disorder in     children. As a result, each time a child with one of these disorders experiences an infection     with GABHS his/her symptoms can reoccur or worsen. Researchers believe that by giving     patients a certain antibiotic, they can prevent GABHS infection and thus prevent the return     of symptoms.      This study is designed to test the effectiveness of the antibiotic Amoxicillin for the     treatment of Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal     infections (PANDAS). Patients will receive Amoxicillin for six weeks and placebos inactive     sugar pills for six weeks in order to see if the medication is truly working. Effectiveness     of the treatment will be based on the presence or absence of symptoms. If at the end of the     study Amoxicillin is proven to be effective treatment for PANDAS patients may be offered the     opportunity to continue taking the medication for an additional six months.   "
162980|NCT00001659|"     Bereavement refers to the expected reactions and sadness associated with the loss of a loved     one. It has been reported that the loss of a spouse is rated as the major life stressor among     survivors of varying ages and diverse cultural backgrounds. Statistics have shown that in the     United States over 800,000 men and women lose a spouse each year.      A wide range of symptoms has been associated with bereavement including; depressed mood,     tearfulness, sleep disturbances, and irrational behavior. Previous studies have shown that up     to 50% of bereaved individuals can develop major depression. Bereavement has also been     associated with dysfunction of the immune system. As a result, bereaved adults are more     vulnerable to infection. However, the exact relationship between bereavement and immunity is     uncertain.      Researchers firmly believe that a relationship does exist between stress, more specifically     bereavement, immunity, and the increased chance of dying following the loss of a long-term     spouse.      The objective of this study is to find possible links between bereavement, depression, and     the immune system. This study will follow a group of elderly bereaved spouses and a group of     elderly people who have not lost a long-term spouse. The group of bereaved individuals will     be followed for approximately 13 months after the loss of their spouse and the group of     controls will be followed for 13 months after entering the study. Researchers will make note     of any clinical, biological, and immunological changes in any participants of the study.   "
162981|NCT00001661|"     The purpose of this study is to investigate the physiology associated with plasticity of the     motor system. Plasticity refers to the process by which neighboring brain cells assume the     responsibilities of damaged or diseased brain cells.      The mechanisms behind this process are unknown. However, researchers have several theories     about how plastic changes take place. Possible explanations include the growth of new     connections between brain cells and the use of previously unused connections.      Researchers plan to use transcranial magnetic stimulation and drug intervention in order to     determine the mechanisms responsible for specific types of plasticity.      Previous studies have shown that certain drugs can affect the mechanisms involved in these     changes. By using one drug at a time, researchers plan to evaluate the role of each of     several different mechanisms in brain reorganization.   "
162982|NCT00001662|"     Glutamate is an amino acid released by brain cells that acts to excite other cells. Glutamate     attaches to special sites on cells called AMPA (alpha-amino-2,3-dihydro-5 methyl     3-oxo-4-isoxazolepropanoic acid) receptors. The brain cells responsible for releasing     glutamate are damaged in Alzheimer's disease and other conditions affecting thinking and     reasoning.      Researchers would like to see if giving patients a drug that attaches to AMPA receptors     improves the symptoms of Alzheimer's disease.      CX516 (Ampalex) is a test drug that affects the AMPA receptors. This study will investigate     the effectiveness and safety of CX516 on patients with Alzheimer's disease.      Patients will be given capsules of CX516 or placebo (sugar pill that neither harms nor helps)     for up to 16 weeks in different amounts. The effectiveness of the drug will be measured by     neurological tests. Safety will be monitored by frequent check-ups and lab examinations.   "
163003|NCT00001688|"     This is a pilot study to evaluate the ability of highly active antiretroviral therapy     administered to children with HIV-1 infection to effect immunoreconstitution in children with     HIV-1 infection. In addition, this study will determine the safety of combination therapy     with ritonavir, nevirapine and stavudine (d4T) as well as the anti-HIV activity of     combination therapy with ritonavir, nevirapine and stavudine. A total of 25 HIV-1 infected     children will be studied, including both moderately and severely immunocompromised     individuals. The children will be treated with ritonavir, nevirapine and stavudine or with     predefined drug substitutions in the case of intolerance. Immunoreconstitution, defined as     the repopulation of naive T cells, will be studied by determining the presence and extent of     production of new naive (thymic derived) CD4+ T cells and their T cell receptor repertoire.     Drug pharmacokinetic profiles in this regimen will be examined.   "
162983|NCT00001663|"     Myoclonus is a condition related to epilepsy of involuntary twitching or jerking of the     limbs.      The purpose of this study is to determine if stimulation of the brain with magnetic pulses     can decrease myoclonus. Researchers believe that this may be possible because in studies on     normal volunteers, magnetic stimulation made areas of the brain difficult to activate for     several minutes. In addition, early studies on patients with myoclonus have shown magnetic     stimulation to be effective at decreasing involuntary movements.      Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to     stimulate brain activity and gather information about brain function. It is very useful when     studying the areas of the brain and spinal cord related to motor activity (motor cortex and     corticospinal tract). Repetitive transcranial magnetic stimulation (rTMS) involves the     placement of coil of wire (electromagnet) on the patient's scalp and rapidly turning on and     off the electrical current. The changing magnetic field produces weak electrical currents in     the brain near the coil. This permits non-invasive, relatively localized stimulation of the     surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending     upon the location, intensity and frequency of the magnetic pulses.      Researchers plan to use rTMS for 10 days on patients participating in the study. The 10 day     period will be broken into 5 days of active repetitive magnetic stimulation and 5 days of     placebo ineffective stimulation. At the end of the 10 day period, if the results show that     rTMS was beneficial, patients may undergo an additional 5 days of active rTMS.   "
162984|NCT00001664|"     The purpose of this study is to assist training doctors about different diseases of the     nervous system affecting sleep.      Patients selected to participate in this study will have any of a variety of sleep disorders.     They will undergo several tests including an overnight recording of brain activity, eye     movement, leg movement, breathing, heart rate, and other measures.      Results of these tests will be used to better understand diseases causing sleep disorders and     may be used to develop better treatments for them.   "
163051|NCT00001753|"     This study will examine the role of temperature in changing energy metabolism in human     muscle. In order to do this, researchers will use magnetic resonance imaging (MRI) to provide     information about how parts of muscle operate during exercise.      Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the     human body without the use of X-ray (radiation). In this study, MRI will be used to measure     the temperature and energy level of specific muscles during rest and exercise. In addition,     the muscles being tested will be heated and cooled to see if temperature directly affects     levels of energy in muscle.   "
162985|NCT00001665|"     The problems in motor activity associated with Parkinson's disease are still poorly     understood. Patients with Parkinson's disease often suffer from extremely slow movements     (bradykinesia) which result in the inability to perform complex physical acts.      Imaging studies of the brain have provided researchers with information about the specific     areas in the brain associated with these motor difficulties. One particular area involved is     the surface of the brain called the cerebral cortex.      Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to     stimulate brain activity and gather information about brain function. It is very useful when     studying the areas of the brain related to motor activity (motor cortex, corticospinal tract,     and corpus callosum). Repetitive transcranial magnetic stimulation (rTMS) involves the     placement of a cooled electromagnet with a figure-eight coil on the patient's scalp and     rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized     stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation     varies, depending upon the location, intensity and frequency of the magnetic pulses.      Researchers plan to study the therapeutic effects of repetitive transcranial magnetic     stimulation (rTMS) on complex motor behavior of patients with Parkinson's disease. In order     to measure its effectiveness, patients will be asked to perform complex tasks, such as     playing the piano while receiving transcranial magnetic stimulation.   "
162986|NCT00001666|"     Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to     stimulate brain activity and gather information about brain function. It is very useful when     studying the areas of the brain related to motor activity (motor cortex, corticospinal tract,     and corpus callosum).      Epilepsy is a condition associated with seizures as a result of an over excitable cerebral     cortex. Despite the introduction of several new antiepileptic medications, less than half of     the patients diagnosed with partial epilepsy are well controlled. However, studies have shown     that non-invasive stimulation of the brain can decrease the excitability of the cerebral     cortex.      Researchers are interested in the potential therapeutic effects of TMS on patients with     epilepsy that have responded poorly to standard medication. This study will use TMS to     decrease the excitability of the areas of the brain responsible for seizures.   "
162987|NCT00001667|"     The purpose of this protocol is to identify families with inherited neurologic conditions,     especially movement disorders, to evaluate affected and unaffected individuals clinically,     and to obtain blood samples for genetic analysis.   "
162988|NCT00001668|"     The von Hippel Lindau (VHL) gene has recently been identified as the genetic defect resulting     in a syndrome of multiple neoplasias. Patients with VHL disease develop retinal angiomata,     renal cysts and/or carcinomas, CNS hemangioblastomas as well as pancreatic cysts and     pheochromocytomas. Investigators have shown the gene to be a tumor suppressor type     proto-oncogene located at chromosomal locus 3p26. The gene includes three exons whose gene     product targets a cellular transcription factor Elongin SIII. Binding of the VHL proteins to     two subunits of this elongation factor inhibits transcription and may play a crucial role in     the clinical development of the von Hippel Lindau phenotype.   "
162989|NCT00001669|"     The drug rhIGF-1 (CEP-151) has been shown to play a key role preclinically in oligodendrocyte     differentiation and survival, as well as, myelin integrity and function. Moreover, in an     animal model of MS, myelin expression, as well as that of its receptors is upregulated at the     time the myelin sheaths regenerate. Finally, administration of exogenous rhIGF-1 to rats with     EAE effectively, closes the disrupted BBB, reduces the number and severity of demyelinating     lesions, and improves neurological function. Thus it seems reasonable to examine the efficacy     and safety, tolerability, and effect of CEP-151 on brain MRI lesions in patients with MS.   "
163004|NCT00001689|"     The pharmacokinetic behavior of vincristine in pediatric patients has not been well     characterized. The present study will obtain detailed information on vincristine     pharmacokinetics in patients being treated for standard risk ALL on CCG protocols 1952/1962.     A limited sampling strategy will be developed, and the interpatient and intrapatient     variability of vincristine pharmacokinetics in children will be studied. A correlation     between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.   "
163114|NCT00002762|"     RATIONALE: Timing of breast cancer surgery may improve effectiveness of treatment and may     help patients live longer.      PURPOSE: Clinical trial to determine whether timing of primary surgery in relation to     menstrual cycle is associated with disease-free survival 5 years after surgery in women who     have stage I or stage II breast cancer.   "
162990|NCT00001671|"     Leukodystrophy is a disease of the white matter of the brain. White matter is the portion of     the brain responsible for conducting electrical impulses from one area of the brain to the     other. Insulating cells called myelin cover the brain and nerve cells in the white matter. If     myelin becomes damaged electrical information cannot be transferred properly.      Many patients suffering from leukodystrophies do not fit the description of any of the     defined types of leukodystrophies and are therefore considered to have a leukodystrophy of     unknown cause.      The purpose of this study is to define groups of patients with leukodystrophies and to work     toward finding the cause of the disorders. In order to do this, researchers will analyze     patients with leukodystrophies of unknown causes. Patients will undergo clinical,     neurophysiologic, biochemical, and genetic examinations and tests.      Researchers believe that by studying these patients and their disorders they will be able to     better understand the causes of myelin destruction, and eventually lead to effective     treatments for these disorders.   "
162991|NCT00001672|"     Repetitive transcranial magnetic stimulation (rTMS) may be able to provide a moderately     detailed localization of language functions in the brain. We propose to test the ability of     rTMS to locate the substrate of visual naming to a limited area of the temporal lobe in     patients with temporal lobe epilepsy before and after surgical resections. The study is     expected to yield information on the organization of language in the temporal lobes and how     unilateral temporal lobe lesions and lobectomy cause relocation of language mechanisms in the     lesioned and in the other hemisphere. It will also be a preliminary step in the development     of a clinically useful procedure for locating critical language areas in potential surgical     candidates.   "
163246|NCT00002923|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to evaluate the effectiveness of KRN5500 in treating patients with     metastatic solid tumors.   "
162992|NCT00001673|"     This protocol has three purposes: (1) to evaluate subjects for inclusion or exclusion from     other NIAAA protocols; (2) to provide a common set of descriptive information that will be     available on all NIAAA research subjects; (3) to allow NIAAA medical and nursing staff to     treat alcoholic patients for acute alcohol intoxication or alcohol withdrawal before     requiring patients to consent to evaluation for participation in research studies.      Information collected will include such items as psychiatric diagnoses, presence or absence     of brain, liver or other organ damage, history of the amount of past alcohol consumption,     other substance use and family history of alcoholism. This information will allow     investigators to determine for which, if any, NIAAA research studies a subject is eligible.     In order to avoid requiring intoxicated subjects to consent for procedures such as HIV     testing, psychiatric interviews, and Magnetic Resonance Imaging (MRI) of the brain we will     obtain consent from all alcoholic subjects in two phases, using two separate consent forms.     The first consent form will express the subject's desire to be admitted to the NIAAA     inpatient unit for the purpose of treatment for alcoholism and will authorize only medical     evaluation and treatment for alcoholism and associated problems. After an alcoholic subject     has been admitted to the inpatient unit and is judged to be no longer intoxicated or     suffering from acute alcohol withdrawal he or she will be presented with the second consent     which will describe the evaluation for participation in other NIAAA research studies.     Non-alcoholic, healthy controls will sign only one consent form describing the data to be     collected and evaluation for participation in other NIAAA research studies.   "
162993|NCT00001675|"     This study was designed to learn more about the areas of the brain involved in the experience     of positive and negative emotions.      Patients who would like to participate in this study will first undergo a screening process     to see if they will be eligible for the study. Patients eligible to participate in the study     will go through two sessions.      During session one, researchers will attempt to evoke positive and negative emotions by     showing patients slides of different emotion-arousing stimuli (pictures of pleasant and     unpleasant scenes). While patients are viewing these slides, researchers will be measuring     patient's heart rate, sweating, and eye-blinking.      During session two, patients will undergo an MRI of the brain while seeing similar     emotion-arousing pictures as in session one. In addition, patients may be asked to play a     simple computer game for a reward of money while researchers use the MRI to measure brain     activity.      Researchers hope to develop methods to evoke positive and negative emotions and     simultaneously (at the same time) see brain activation in normal volunteers, alcoholics, and     recovered alcoholics.<TAB>   "
162994|NCT00001676|"     This study will test the safety and effectiveness of combination therapy with     cyclophosphamide (Cytoxan) and fludarabine in treating lupus nephritis (kidney inflammation).     This condition, common in patients with systemic lupus erythematosus, is caused by abnormal     action of immune cells called lymphocytes against the kidneys. Left untreated, severe cases     can result in loss of kidney function. The current treatment of choice-intermittent high     doses (pulses) of cyclophosphamide-does not work in all patients and causes infertility in     many women. The rate of infertility in men is not known. This study will examine whether     fludarabine can safely be given with significantly lower doses of cyclophosphamide, and if     this combination controls kidney inflammation.      Patients 18 years of age and older with severe lupus nephritis (called proliferative lupus     nephritis) may be eligible for this study. Candidates will have a history and physical     examination; blood and urine tests; chest X-ray; electrocardiogram; cancer screening that may     include a Pap smear, mammogram, rectal examination, PSA testing, and sigmoidoscopy.      Participants will be divided into one of the following treatment groups:      Group 1-Patients undergo three treatment cycles of cyclophosphamide, taken by mouth, and     fludarabine, injected subcutaneously (under the skin). Patients receive both drugs on day 1     of the cycle, and fludarabine alone on days 2 and 3. This regimen is repeated once every 5     weeks for three cycles.      Group 2-Same as for Group 1, except fludarabine injections are given intravenously (through a     vein) for the second treatment cycle. Patients in this group have frequent blood sampling     during the first and second treatment cycles to monitor blood levels of the drug. Samples are     collected before the first injection is given and at 0.5, 1, 1.5, 2, 4, 8, 24 and 48 hours     after the third injection. A total 12 tablespoons of blood is drawn over a 2-month period.      All patients will have blood drawn once or twice a week during the first two cycles and then     less frequently to monitor blood counts. Some patients will have the following additional     procedures to test the effects of treatment on lymphocytes:        1. Blood sample collection        2. Bone marrow aspiration-The skin over the hip bone is cleaned and a local anesthetic is          injected into the outer covering of the bone. Bone marrow is suctioned through the          needle into an attached syringe. The procedure is done before treatment begins, at the          end of treatment, and 6 months after treatment.        3. Tonsillar biopsy-The tonsils are numbed with a local anesthetic and 1 to 4 pieces of          tissue are removed using special forceps. The procedure is done before treatment begins,          at the end of treatment, and 6 months after treatment.        4. Magnetic resonance imaging (MRI) of the abdomen-The patients lies on a table in a narrow          cylinder (the MRI scanner) containing a strong magnetic field, which is used to create          images of parts of the body in small section views.      Patients will be followed for at least 24 months to monitor late side effects and the     response to treatment.   "
162995|NCT00001677|"     The safety profile and efficacy of combination therapy will be evaluated using methotrexate     (MTX) and the nucleoside analog fludarabine in 40 patients with severe refractory rheumatoid     arthritis. The patients enrolled will be those who have experienced inadequate disease     control with MTX alone or in combination with other immunosuppressive drugs such as     sulfasalazine (SSZ), cyclosporin A (CsA), or hydroxychloroquine (HCQ). In this randomized,     double-blind, placebo controlled trial, patients will be maintained on oral MTX at 17.5     mg/week to which either placebo or subcutaneous fludarabine at 30 mg/m(2) daily for three     consecutive days per month will be added for four months. The fludarabine (or placebo)     treatment period will be followed by two months of follow-up, at which time patients will be     evaluated for response. Patients will be monitored for adverse effects/tolerability, disease     activity, and changes in synovial volume as measured by magnetic resonance imaging (MRI).     Additionally synovial biopsies will be obtained before and after treatment for investigation     of infiltrating cell numbers and phenotypes, cytokine profiles, Th1 versus Th2 responses, and     angiogenesis.   "
163005|NCT00001693|"     This is a randomized, placebo-controlled Phase I/II multi-center trial, of the safety and     efficacy of Celecoxib in a cohort of 81 HNPCC subjects and gene carriers. The three proposed     intervention arms are: Celecoxib (to be provided by Searle) will be administered at 200mg     p.o. BID x 12 months or 400mg p.o. BID x 12 months vs. Placebo p.o. BID x 12 months.     Assessment of endoscopic and tissue-based biomarker endpoints will be conducted at baseline     and 12 months on study drug or placebo. Patients that present with polyps at baseline will     undergo a month 4 endoscopy. Plasma drug trough samples for pharmacokinetic analyses will be     collected at baseline and month 12. NCI-Chemoprevention Branch will coordinate the efforts     and activities of all sites.      Safety monitoring will occur via in-patient interviews with exams at month twelve; symptom     questionnaires completed at baseline, months one, four, eight and twelve; blood and     urinalysis at baseline and at months one, four, eight and twelve. A post-administration     telephone call to evaluate side effect resolution will occur at months 13-14 for patients who     have unresolved adverse events at the end of month 12.   "
162996|NCT00001678|"     This study attempts to identify the genes responsible for rheumatoid arthritis (RA), or     inflammation of the joints. It is known that genes play an important role in RA, but their     number and significance have not been determined. RA tends to run in families. This study     will examine the DNA (hereditary material) of patients with RA and their family members to     try to determine which chromosomes(s) contain the genes responsible for the disease.      Patients with rheumatoid arthritis and their family members may be eligible for this study.      Participants with RA who have a brother or sister with RA will undergo the following     procedures:        -  Review of their medical records        -  Medical history        -  Examination of the joints        -  Hand X-rays        -  Blood tests      Participants who 1) do not have RA but who have a relative with the disease, or 2) have RA     and a relative other than a brother or sister who has the disease will provide a blood sample     or a buccal (cheek) cell sample. Cheek cells are obtained by swishing a small amount of     mouthwash in the mouth or by lightly bushing the inside of the cheek with a swab or brush.      The samples will be tested for rheumatoid factor, DNA studies, and HLA type (a blood type     found on white blood cells). Certain HLA types have been associated with an increased risk or     severity of RA.   "
163069|NCT00002697|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with radiation therapy and peripheral stem     cell transplantation may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy plus     radiation therapy followed by peripheral stem cell transplantation in patients with     refractory or recurrent non-Hodgkin's lymphoma.   "
162997|NCT00001679|"     This study will evaluate the 2-5 year outcome of a cohort of 250 patients with early     synovitis, who were recruited into protocol 94-AR-0194 (The Pathogenesis of Inflammatory     Synovitis: A Study of Early Arthritis). Clinical, radiographic, and functional outcome     parameters, particularly those relating to articular damage and functional loss, will be     evaluated and related back to clinical, serologic, immunogenetic, and pathologic variables     identified at the onset of the arthropathy. A model will be generated which incorporates and     weighs the variables in order to determine diagnostic and prognostic markers in the early     stages of arthritis. Synovial tissue samples have been obtained from the entire cohort at the     initial visit of protocol 94-AR-0194. Studies of these biopsies have so far demonstrated     evidence for the presence of infectious agents in a proportion of the samples, and have     generated information regarding the cytokine profiles in the early stages of synovitis. In an     attempt to further define the pathogenetic mechanisms of synovitis longitudinally, biopsies     will be repeated on selected subsets of the cohort. Specific questions to be answered relate     to the persistence of microbial agents in the synovium, and to the evolution of cellular and     molecular mechanisms which mediate the invasive, destructive potential of the synovial     lesion. It is anticipated that these studies should prove valuable to clinicians who are     attempting to stratify patients for therapeutic strategies, early in their disease course.     They should also prove valuable in enhancing the understanding of the pathogenetic mechanisms     of synovitis.   "
162998|NCT00001680|"     The purpose of this double-masked, pilot trial is to determine whether 20 percent thalidomide     ointment is safe and effective for the treatment of chronic discoid lupus erythematosus     (CDLE) when used under an occlusive dressing. Seventeen patients with two similar lesions     will have lesions randomized to receive either intervention or placebo therapy.   "
162999|NCT00001681|"     The factors that influence HIV disease progression are not well understood. While larger     amounts of circulating virus (high 'viral loads') predict future adverse clinical events,     many of the clinical factors responsible for high viral loads and disease progression remain     unknown. Certain clinical events and defined interventions are associated with increases in     plasma viral RNA concentrations. One of these clinical interventions is immunization;     immunization with several vaccines have been shown to increase plasma HIV RNA concentrations.     Even though vaccination can lead to transient increases in plasma HIV concentrations, certain     vaccines, including influenza vaccine, are still recommended for HIV patients because the     risks of the disease targeted by the immunization are held to be greater than the     immunization itself. Therefore, immunization with influenza vaccine can be considered a     model, clinically indicated intervention, given at a known time which stimulates HIV     replication. For influenza immunization, and for other treatments leading to increases in     viral RNA concentrations is not available. We hypothesize that immunization with influenza     vaccine, and perhaps other immune stimulatory events, lead to an increase in HIV replication     through a regulatory system involving cytokines, signal transduction systems, transcription     factors, effects on the cell cycle, and increased expression of additional gene products     needed for viral replication, such as genes of the nucleic acid biosynthetic pathways. While     experiments aimed at investigating one or another particular part of this regulatory system     can be performed with traditionally available technologies, such technologies cannot provide     comprehensive information concerning a large number of the regulatory events that may be     involved in mediating the increase in HIV RNA concentration. In this protocol, we aim to     develop the methodologies needed to determine changes in expression of many of the genes     which may be involved in mediating the regulation of HIV expression in HIV-infected patients     using cDNA microarray technologies. Once the methodologies are developed, such work may     provide new insights into the regulatory systems controlling HIV expression in HIV-infected     patients may provide new insights into the pathogenesis of HIV disease.   "
163000|NCT00001683|"     Matrix metalloproteinases (MMPs) are a class of membrane bound enzymes that are involved in     the degradation of the extracellular matrix. MMP-2 and MMP-9 have been associated with the     progression of cancer. It is hypothesized than an imbalance between MMPs and MMP inhibitors     allows the destruction of the extracellular matrix and enhances the ability of the tumor     cells to grow and metastasize. By inhibiting MMPs, it is thought that angiogenesis and     metastasis can be inhibited. This is a phase I study of COL-3, an oral matrix     metalloproteinase inhibitor, in patients with refractory metastatic cancer. COL-3 is a     chemically modified tetracycline derivative. Patients must have clinically progressive     disease documented within 1 month prior to entry to be eligible for treatment. Patients must     have also failed therapy of proven efficacy for their disease and have an ECOG performance     status of less or equal than 2. Patients must be willing to travel from their home to the NIH     for follow-up visits. Patients with brain metastases or primary CNS malignancies are not     eligible. Concurrent therapy for their cancer (i.e., radiation therapy, chemotherapy, etc.)     will preclude participation. We will be defining the maximum tolerated dose, the toxicity     profile, characterizing the pharmacokinetics, and evaluating the effect of COL-3 on several     biological endpoints.   "
163001|NCT00001685|"     This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201     restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be     administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with     melanoma. The study is designed to evaluate the potential therapeutic role, immunologic     effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously.      Immune reactivity to the peptide epitope will be monitored in all patients by analysis of     melanoma-specific T cell precursors prior to and after immunization.   "
163002|NCT00001686|"     This protocol is designed to evaluate children with cancer who appear to be probable     candidates for future protocol entry or have disease manifestations that are of unique     scientific importance or educational value.   "
163258|NCT00002937|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel with or without     PSC 833 in treating patients with metastatic breast cancer.   "
163011|NCT00001702|"     Innate immunity plays an important role for fungal recognition and initiation of fungicidal     activity. We hypothesize that subtle differences in different molecules of innate immunity     may contribute to either the predisposition or clinical course of infection with     Blastomycosis dermatitidis. To test this hypothesis, we propose to analyze the allelic     frequencies of 15 different genes (mannose binding lectin, Fc-gamma receptor IIa and IIb,     Fc-gamma receptors IIIa and IIIb, myeloperoxidase, tumor necrosis factor-alpha and -beta,     interleukin 1A and 1B, interleukin-1 receptor antagonist, interleukin-10, NRAMP-1,     chitotriosidase, and chemokine receptor 5) and their intragenic polymorphic forms and to     compare this data to the incidence and severity of Blastomycosis dermatitidis infection. With     this study we hope to identify a group of molecules of innate immunity which influence the     risk and severity of invasive Blastomycosis dermatitidis infection.   "
163267|NCT00002946|"     Phase I trial to study the effectiveness of penclomedine in treating patients with malignant     solid tumors or lymphomas. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die.   "
163006|NCT00001695|"     Simultaneous use of alternative or complementary medical therapies by cancer patients     undergoing conventional medical treatment is extremely common and may not always be disclosed     to the patient's treating physician. Cancer patients undergoing Phase I therapy on clinical     trials constitute a special population of patients, since by definition, their prescribed     therapy is scientifically unproven in terms of efficacy. Phase I patients are closely     monitored for adverse effects in order to identify and characterize the toxicities and to     define a tolerable dose of their experimental treatment. Thus, the unrecognized use of     alternative therapies by patients actively enrolled in phase I trials may potentially     confound rational drug development by causing adverse side effects or by contributing to drug     interactions. Examples of clinical toxicities induced by alternative medical treatments     include liver dysfunction or renal failure caused by herbal preparations, or hematologic     abnormalities, such as eosinophilia-myalgia syndrome caused by tryptophan food supplements.     Therefore, it is important to document and determine the prevalence of alternative therapy     use in this specific patient population; however, this issue has not previously been examined     in a scientifically rigorous manner. We propose to conduct a survey and interview study of     phase I cancer patients enrolled in ongoing clinical trials at the National Cancer Institute     to determine the prevalence of alternative therapy use in this population. This study will     also examine patient attitudes and perceptions regarding their use of alternative therapy as     compared with their scientifically-sanctioned phase I experimental therapy. This information     has important implications for drug development.   "
163007|NCT00001696|"     Genistein is a natural product found in soy beans; its consumption has been associated with a     low incidence of metastatic prostate cancer. Genistein is a known protein-tyrosine kinase     inhibitor, and in preclinical studies it has been shown to increase cell adhesion. Increases     in cell adhesion in vivo would phenotypically reverse the first step in the metastatic     cascade, potentially preventing metastasis formation, and is consistent with epidemiologic     findings. This study seeks to determine the pharmacokinetics of genistein in humans by     administering a single dose of genistein and performing a pharmacokinetic analysis. Patients     will be treated with two formulations of genistein (a 43% genistein preparation or a 90%     preparation). This is a phase I study, and patients will be treated on one of three dosing     levels. Patients will be randomly assigned to receive one formulation first, followed by a     washout period, and will then receive the second preparation (i.e. a randomized cross over     design). Information from this study will be used to optimally design a multiple dose study     wherein patients will be treated for longer periods of time.   "
163008|NCT00001698|"     In Phase II trials, treatment with ketorolac tromethamine oral rinse has been shown to block     periodontal disease progression even in the absence of standard clinical intervention such as     scaling and root planing which is routinely done to reduce the periodontal pathogen load that     is driving the local destructive host inflammatory response. Resolution of periodontal     disease has a favorable effect on normalizing the cellular and biochemical indices of     inflammation as reflected by histological changes as well as the levels of prostaglandin E2     (PGE2) and interleukin I beta (IL-1beta). In this trial, we will prospectively evaluate if     eliminating the inflammatory process (via inhibition of PGE2 biosynthesis) in the oral cavity     has a favorable impact on reversing oropharyngeal leukoplakia. To test this hypothesis, up to     57 prospectively identified individuals with objective findings of oropharyngeal leukoplakia     will be randomized to receive either a mouth rinse containing ketorolac or placebo. Ketorolac     is a 7-fold selective inhibitor of cyclooxygenase-2 (Cox-2), which has been designed for     local delivery to maximize the drug exposure to critical oral target tissues while minimizing     gastric and systemic exposure to the drug. All responses will be determined at the three     month completion of trial using the response criteria developed at MD Anderson Cancer Center.     The drug will be given for three months and then all the patients will be followed for one     additional month off all oral treatment to observe for late side effects. Based on the     analysis of oral exam and photographically documented change in the pretreatment area of     leukoplakia, the response of all patients will be determined.      The evaluation of the outcome will include a measurable secondary endpoint consisting of an     assessment of histological change as determined by serial punch biopsies of the oral cavity.     In addition, a panel of carcinogenesis and inflammatory markers will be serially measured at     baseline, at one month follow up or at study conclusion. In the residual tissue, other     bioassays will be evaluated to determine their suitability as intermediate endpoint markers.     The purpose of this study is a preliminary evaluation of the effectiveness of ketorolac as a     potential chemoprevention agent for oropharyngeal cancer. If ketorolac administration in this     preliminary Phase IIB trial is associated with reversal of leukoplakia, then a definitive     Phase III chemoprevention trial with a cancer reduction endpoint (most likely in a     cooperative group-type setting) may be the next validation step.   "
163009|NCT00001699|"     The proposed study has two specific aims 1) to gather data about treatment adherence levels     among adolescents (11-21 years) with HIV and 2) to obtain information about the adolescents     and mothers' health beliefs and examine their relationship to the adolescents' adherence     levels. This pilot study is designed to gather preliminary data about the feasibility of     using several new measures with this population. To achieve these aims, a convenience sample     of approximately 45 adolescents with HIV will re recruited. The adolescents and their mothers     will complete a brief questionnaire about their health beliefs. A 24-hour recall interview     format will be used to assess the adolescents' treatment adherence to prescribed oral     medication. The adolescent will complete recall interviews on three random days over a two     week period. Data analysis will be primarily descriptive, but will be used to generate more     specific hypotheses for future research studies. The long-term goal of this research is to     better identify adolescents with HIV at risk for non-adherence and design empirically derived     interventions to improve their adherence levels. The health beliefs measure may also be     useful in identifying irrational beliefs about the illness or treatment that can then be     targeted for cognitive restructing in psychological interventions.   "
163010|NCT00001701|"     Innate immunity plays an important role for fungal recognition and initiation of fungicidal     activity. We hypothesize that subtle differences in different molecules of innate immunity     may contribute to either the predisposition or clinical course of infection with Cryptococcus     neoformans. To test this hypothesis, we propose to analyze the allelic frequencies of 15     different genes (mannose binding lectin, Fc-gamma receptor IIa and IIb, Fc-gamma receptors     IIIa and IIIb, myeloperoxidase, tumor necrosis factor-alpha and -beta, interleukin 1A and 1B,     interleukin-1 receptor antagonist, interleukin-10, NRAMP-1, chitotriosidase, and chemokine     receptor 5) and their intragenic polymorphic forms and to compare this data to the incidence     and severity of C neoformans infection. With this study we hope to identify a group of     molecules of innate immunity which influence the risk and severity of invasive C neoformans     infection.   "
163060|NCT00002684|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, use     different ways to stop tumor cells from dividing so they stop growing or die. Combining more     than one drug and giving drugs in different ways may kill more tumor cells.      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating     patients with metastatic urinary tract cancer that cannot be treated with surgery.   "
163012|NCT00001703|"     About 27,000 new cases of renal cell carcinoma (RCC) are diagnosed every year in the United     States. 11,000 of these cases will die from the disease. More than half of patients present     with advanced or metastatic disease for which chemotherapy plays a very limited role.     Therefore, development of another therapeutic approach is needed. Cancers in humans are     commonly associated with mutations in dominant and recessive oncogenes. These genes produce     mutated proteins that are unique to cancer cells. Von Hipple-Lindau (VHL) gene which is     associated with the development of the VHL disease, has been recently mapped and cloned, and     it is found to be mutated in 57% of sporadic renal cell carcinomas.      Data in mice have shown the generation of major histocompatibility complex (MHC) restricted     cytotoxic T lymphocyte (CTL) that are capable of detecting endogenous cytoplasmic peptide     derived from mutated oncogenes. In addition, we have recently demonstrated, by conducting     different phase I clinical trials in which we vaccinate cancer patients with mutated Ras or     p53 peptides corresponding to the abnormality patients harbor in their tumors, that in some     patients we can generate immunological responses represented by the generation of lymphocytes     (CD4+ and/or CD8+). In the current study, we would like to extend our observations to test     whether VHL tumor suppressor protein can be immunologically targeted by vaccination. We have     identified specific epitopes along the amino acid sequence of the VHL protein, which     represent known specific human leukocyte antigen (HLA) class-I binding motifs. These amino     acids stretches in the VHL protein correspond to the area of the point mutation hot spots.     Therefore, we propose to treat patients with sporadic RCC who carry VHL mutations in their     tumors with corresponding mutant VHL peptide vaccination. This vaccination will be done     either by using pulsed-autologous peripheral mononuclear cells with the peptides, or peptides     administered subcutaneously alone or in combination with cytokines.   "
163013|NCT00001705|"     Patients with metastatic melanoma who are HLA-A201+ will be immunized with a modified peptide     from the gp100 molecule that contains a signal sequence designed to improve peptide     presentation by antigen presenting cells. This peptide called gp100:ES209-217 (210M) will be     administered either alone or in combination with high or low dose IL-2. Patients will be     evaluated for clinical response, as well as undergo studies of the immunologic response to     the peptide immunization.   "
163014|NCT00001711|"     Magnetic resonance is an imaging technique that uses magnetic fields and radio waves to     create images of the body. The technology used in magnetic resonance imaging continues to     improve. Advancements in magnetic resonance imaging (MRI) requires researchers to study new     techniques in normal volunteers in order to understand how to use them in patients with     diseases.      In this study researchers plan to do a variety of diagnostic tests including magnetic     resonance imaging on normal volunteers. The studies may involve injections of contrast media,     substances injected into the blood of participant that improves the image created by the MRI     scanner. The study is not expected to benefit the participants. However, information gathered     from the study may be used to improve diagnostic techniques and develop new research studies.   "
163015|NCT00001712|"     Following guidelines issued by the Centers for Disease Control, the Clinical Center     implemented a Universal Precautions policy in November 1987 in an attempt to reduce     healthcare workers' risks for occupational exposures to bloodborne pathogens. All hospital     personnel whose jobs entailed potential exposure to patients' blood and body substances were     required to attend a training session and complete a written examination. Based on data from     surveys conducted before and twelve months after training in Universal Precautions, the     frequency of cutaneous exposure to blood decreased by 50% in temporal association with     implementation of Universal Precautions. Staff at the Clinical Center are required to take a     refresher course in Universal Precautions annually.      The prevalence of bloodborne infections is high in Japan; however, Universal Precautions are     not widely practiced in Japan. This study is designed: 1) to evaluate and compare nurses'     knowledge of the epidemiology, pathogenesis, occupational risks, and appropriate prevention     strategies for managing patients infected with bloodborne pathogens in the healthcare setting     in seven university hospitals in Japan and at the Clinical Center of the National Institutes     of Health in the US; 2) to compare self-reported levels of compliance with existing infection     control recommendations designed to limit risk for exposure to bloodborne pathogens in all     four institutions; 3) to compare self-reported frequencies of cutaneous exposures to blood at     the four hospitals in the study; and 4) to evaluate the effect of educational intervention on     nurses perceived compliance with recommendations and on the frequency of self-reported     exposures to blood.   "
163016|NCT00001713|"     Acute deep venous thrombosis (ADVT) of the lower extremity is a common disorder. Traditional     treatment with anticoagulation therapy is effective in reducing the associated risk of     pulmonary embolism, but is ineffective in restoring patency of the venous system of the lower     extremity. While systemic thrombolytic therapy has been shown to be more effective than     anticoagulation, catheter directed local thrombolytic therapy is the most effective treatment     in restoring venous patency. Current treatment regimens are based on use of urokinase,     infused continuously through catheters imbedded into the thrombus. These treatment regimens     require doses on the order of 10,000,000 units of urokinase, resulting in significant     bleeding complications and prohibitive costs.      Experience at NIH with pulse-spray treatment of axillary subclavian venous thrombosis with     rtPA indicates that this is a highly effective and safe alternative thrombolytic regimen. The     proposed protocol is designed to evaluate the efficiency, safety, and doses of rtPA     associated with pulse spray directed rtPA treatment of the more extensive venous thrombosis     encountered in the lower extremity.   "
163061|NCT00002687|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients who     have mycosis fungoides.   "
163062|NCT00002688|"     RATIONALE: Some cancers become resistant to chemotherapy drugs. Combining cyclosporine with     chemotherapy may prevent resistance to the drugs and allow the cancer cells to be killed.      PURPOSE: Randomized phase II trial to study the effectiveness of adding cyclosporine to     combination chemotherapy in treating patients with relapsed or refractory acute myeloid     leukemia.   "
163017|NCT00001714|"     This project will measure magnetization transfer (MT) parameters on normal subjects using two     novel approaches. The first is the investigation of asymmetric MT effects with respect to the     zero or on-resonance reference point. The technique measures the difference in MT effect     between two symmetrically positioned off-resonance MT pulses in the positive and negative     frequency ranges. Prior research with this technique in the kidney show a difference in the     macromolecular lineshape that correlates to a specific metabolite. The second approach,     utilizing a subset of the acquisitions from the first approach, will test newly developed     formulation to calculate the macromolecular fraction, or fraction of proton density that     accounts for MT. We foresee these measurements may significantly develop our understanding of     MT and introduce diagnostic and quantitative tools to study human tissues.   "
163018|NCT00001715|"     The Hematology Service provides hematology consultations for patients at the Clinical Center     and participates in the training of hematology fellows. Patients with a broad range of     hematologic disorders must be available in order for the senior staff of the Service to     maintain clinical expertise and to provide the breadth of experience necessary for the     fellowship program. The purpose of this protocol is to meet these needs by allowing the     Hematology Service to see patients with a spectrum of hematologic diseases not studied on     existing research protocols at the NIH. These patients will be evaluated over the course of     several outpatient visits and returned to the care of their referring physicians.This study     was developed to evaluate and possibly treat patients with blood disorders. The Hematology     Service of the National Institutes of Health is responsible for the care of patients     participating in research studies. In addition the Hematology Service also provides     consultation for small groups of patients with blood disorders that have not been diagnosed     or that may need special testing.      This study will also provide doctors at the NIH the opportunity to learn more about a wide     range of blood disorders and conditions. Patients participating in this study will be     evaluated over the course of several outpatient visits and will continue to be cared for by     their regular physician.   "
163019|NCT00001716|"     Sickle cell anemia is the most common genetic disease affecting African-Americans. About 1 in     every 1000 African-Americans has the disease and 1 in every 12 carry the genes that could be     passed on to their children. People with sickle cell anemia have abnormal hemoglobin, the     molecules responsible for carrying oxygen in the blood. The abnormal hemoglobin can cause     damage to the red blood cells. The damaged red blood cell may then stick in the blood vessels     and cause pain and injury to organs. Some of the complications caused by the sticking of     blood cells are called acute pain crisis and acute chest syndrome (ACS).      Nitric oxide (NO) is a gas that has been proposed as a possible therapy for the ACS     complication of sickle cell anemia. Studies have shown that NO may favorably affect sickle     cell hemoglobin molecules, thereby improving blood flow through small vessels.      This study is designed to evaluate the effects of NO, when taken in combination with a drug     called nitroglycerin on patients with sickle cell anemia and normal volunteers. The effects     of these two drugs only last while the patient is receiving them. Researchers hope the     information learned from this study will help to develop new therapies for sickle cell     anemia.   "
163020|NCT00001717|"     This protocol seeks to better understand the various factors which influence an HIV infected     individual's decision to participate in clinical research, and especially how the offer of     payment influences the decision to participate and understanding of the risks, benefits and     purpose of the research. Subjects will be HIV infected individuals participating in or being     screened for participation in intramural HIV studies being conducted by the NIAID, CCMD, and     NCI. Willing subjects will be recruited from studies that offer payment and comparable     studies that do not pay. The primary methodology is an interview via a survey schedule. Use     of the interview schedule will be preceded by a focus group of about 7-10 individuals and     pretesting of the survey instrument. Paid and unpaid subjects will be compared with respect     to motivations, understanding, willingness to withdraw, and sociodemographics.   "
163021|NCT00001718|"     Electropalatography (EPG), a noninvasive device that provides specific visual output on     tongue-palate contact, has well-established usefulness as a biofeedback tool in speech     therapy. While EPG has also been shown to be capable of revealing the details of     linguopalatal interactions during swallowing, its applicability in swallowing therapy has not     been evaluated to date. This study will determine if EPG can facilitate bolus propulsion in     patients presenting with swallowing problems of the oral phase. Seven patients with oral     dysphagia will be selected to serve as subjects based on specific inclusion and exclusion     criteria, and each will be custom-fitted with a pseudo-palate. Each patient will undergo four     45-minute sessions of biofeedback training with emphasis on developing systematic     front-to-back anchoring of the tongue against the palate during propulsion of liquid and     semisolid boluses. Ultrasound imaging will be used to determine swallow durations and     identify oral deficits of swallowing before the EPG biofeedback training, and to identify any     changes that may result from the training. Quantitative measurements will also be made of the     swallow-related EPG contact timing and pattern before and after training and compared for     each individual subject as a function of training and bolus volume. Appropriate statistical     analyses will be conducted.   "
163022|NCT00001719|"     This study will use magnetic resonance imaging (MRI) to examine blood flow patterns in the     arteries and veins of the liver and abdomen. It will 1) determine the best way to measure     blood flow in these vessels, and 2) make detailed measurements of the blood flow patterns of     these vessels. Information about normal liver blood flow may help explain the role of blood     flow in liver disease.      Normal healthy volunteers 18 years of age and older may be eligible for this study. They will     undergo MRI-a diagnostic tool that uses a strong magnetic field and radio waves to show     structural and chemical changes in tissue and the speed of moving blood. The patient lies on     a stretcher inside a metal cylinder (the scanner) for 1 to 1.5 hours and will be required to     lie very still for 10 to 15 minutes at a time. Blood pressure, heart rate, breathing and the     amount of oxygen in the fingertip are measured during the scan.   "
163063|NCT00002689|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Radiation therapy combined with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam     radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that     cannot be removed surgically.   "
163043|NCT00001741|"     The renin angiotensin system is a complex process involving hormones and enzymes that     regulate blood volume and blood pressure. The hormone angiotensin II is responsible for     making blood vessels narrow or constrict. Angiotensin II is found in the blood and can attach     to special sites called receptors on blood vessel walls. These receptors are programmed to     accept angiotensin II and cause a constriction of the blood vessel. This function is found in     the genetic information of each individual person.      Occasionally patients have changes in their genes related to angiotensin II receptors. These     changes may result in the receptors acting differently to angiotensin II, which may affect     the function of blood vessels.      This study is designed to improve researchers understanding of the physiological effects on     blood vessels associated with mutations of the genes responsible for angiotensin II receptor     function.   "
163023|NCT00001720|"     Bones grow and stay strong through a continuous process of formation (building) and     resorption (break down). When more bone is formed than resorbed, the density (level of     calcium) in bone increases and the bones become stronger. However, if more bone is resorbed     than formed the density of bone decreases and the bones become weak. This condition is called     osteoporosis.      Osteoporosis is a rare but serious condition in children. Childhood osteoporosis can occur     without a known cause (idiopathic juvenile osteoporosis). Children with osteoporosis suffer     from pain, inability to stay active, and increased amounts of broken bones, including     fractures of the spine. Even mild childhood osteoporosis may have long-term consequences     since individuals who achieve a less than normal bone composition (peak bone mass) during the     first 20-30 years of life may be at an increased risk for osteoporosis as adults.      Alendronate (Fosamax) is a drug that works by stopping bone resorption (break down). It has     been used to treat post-menopausal osteoporosis, male osteoporosis and adults with     osteoporosis due to long-term steroid therapy. The goal of this study is to determine the     effectiveness of alendronate in children with idiopathic juvenile osteoporosis. Researchers     believe that children treated with alendronate will improve bone strength and decrease the     amount of fractures caused by osteoporosis.   "
163024|NCT00001721|"     Smith-Lemli-Opitz Syndrome (SLOS) is a genetic disorder (autosomal recessive) caused by an     abnormality in the production of cholesterol. The disorder can occur in both a mild or     severe form. SLOS is associated with multiple birth defects and mental retardation. Some of     the birth defects include; abnormal facial features, poor muscle tone, poor growth, shortened     life span, and abnormalities of the heart, lungs, brain, gastrointestinal tract, limbs,     genitalia, and kidneys.      There is no known cure for SLOS but recently patients have been treated with increased     amounts of cholesterol in their diet. The cholesterol in a persons diet is unable to correct     the abnormalities in the patient's organs, but researchers hope it will improve growth     failure and mental retardation.      This study was developed to answer questions about the causes and complications of SLOS, as     well as the effectiveness of cholesterol treatment. The study will enroll patients diagnosed     with SLOS, and their mothers. The objectives of the study will be to address the following     questions:        1. <TAB> What is the prognosis / natural history of the demyelination in the nervous system          of patients with SLOS?        2. <TAB> Do patients with SLOS have other problems concerning the function of their          endocrine systems?        3. <TAB>What are the genetic make-ups of patients with SLOS?        4. <TAB>Can further studies of cholesterol metabolism and genetic testing, using SLOS          fibroblasts, increase the understanding of SLOS?<TAB>   "
163025|NCT00001722|"     Leptin is a hormone that acts in the body as a chemical messenger. It is produced in fat     cells and is believed to regulate body weight in humans. Leptin decreases appetite and     influences the energy balance of the body.      This study will attempt to measure levels of leptin production in the fat pad of the body by     using a process called microperfusion. Microperfusion works by inserting 2 to 3 probes (thin     tubes) into the fat pad around the belly button. These probes can measure chemicals in an     area known as the extracellular space. This is the small space between cells and blood     vessels that hormones, medicines, nutrients, and salts travel through.      The study will investigate the effects of a meal, insulin, glucose (sugar), and the     medication isoproterenol on leptin levels. Researchers believe that leptin levels are     regulated along with the enzyme, hormone sensitive lipase (HSL). When hormone sensitive     lipase is activated fat is broken down in a process called lipolysis. In addition, increased     levels of HSL result in decreased levels of leptin, which in turn increases appetite and food     intake.   "
163026|NCT00001723|"     Obesity is a condition affecting one-third off the U.S. population and is a major risk actor     for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the     blood), hypertension (high blood pressure), and other disorders of the heart and lungs.     Individuals with the onset of obesity during childhood or adolescence are at an increased     risk of obesity-related, diseases, both during adolescence and later in adult life.      African American girls and women are at an increased risk for obesity, and have substantial     rates of obesity-related diseases and causes of death. Further, many African American adult     women fail to respond to many of the therapeutic approaches used to treat obesity. At present     there are no medical therapies proven effective for the correction of severe obesity in     children or adolescents.      One medication that may have a favorable risk-benefit ratio in pediatric populations is     Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in     the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten     in the diet. Xenical appears to be effective for reducing weight and obesity-associated     diseases in obese adults.      Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17     year old severely obese African American and Caucasian children and adolescents who have one     or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic     steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).   "
163032|NCT00001729|"     Hepatitis C is a major cause of liver disease in the United States and leads to cirrhosis of     the liver in approximately one-third of patients some of whom will ultimately suffer from     liver failure or liver cancer. At present, the recommended therapy of hepatitis C is the     combination of alpha interferon and ribavirin given for 6 to 12 months. Ribavirin is a     antiviral drug that is given by mouth. Interferon is both an antiviral and an immune     medication which must be given by injections (three times a week) and has many difficult side     effects. The purpose of this study is to determine whether the combination of ribavirin and     interferon improve the liver disease of hepatitis C and whether improvements can be     maintained by continuing ribavirin therapy long-term. This study will take 100 to 120     patients suffering from hepatitis C and place them under combination drug therapy with alpha     interferon and ribavirin. The course of drug therapy is scheduled to last 6 to 12 months.     Patients will be selected after appropriate screening for hepatitis C virus and elevated     liver enzymes are conducted and liver biopsy shows chronic hepatitis with some degree of     injury and scarring.      During the first 6 months of the study, subjects will be asked to return to the outpatient     clinic for routine check-ups and blood tests every 2 to 4 weeks. Blood tests will include     tests for hepatitis C virus. If the virus test becomes negative on treatment, the therapy     will be considered successful and will be continued for a full 6 or 12 months (depending upon     the strain of virus).      If the virus test does not become negative during the first six months of treatment, subjects     will be considered non-responders and will stop taking interferon but will continue on     ribavirin alone or an identically appearing placebo tablet. These non-responsive subjects     will continue this therapy for an additional 12 months. (A year-and-a-half total).      Upon completion of the drug therapies, subjects will be requested to submit blood samples and     undergo a liver biopsy to determine if the therapy was successful. Test results that reveal a     loss of hepatitis C antibodies or normal levels of liver enzymes will be deemed successful.      Patients that have successful laboratory test results will be considered for continuation of     ribavirin therapy. Patients that received placebo for a year will be eligible to receive     ribavirin long-term at the end of the study.   "
164391|NCT00004802|"     OBJECTIVES:      I. Assess the efficacy of dichlorphenamide in the treatment of episodic weakness attacks in     patients with hyperkalemic periodic paralysis, paramyotonia congenita with periodic     paralysis, and hypokalemic periodic paralysis.   "
163027|NCT00001724|"     This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug     flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery.     Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain.      Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be     eligible for this study.      Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery,     they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and     a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At     the time of surgery, patients will also be given flurbiprofen or a placebo formulation     (look-alike substance with no active ingredient) directly into the extraction site and a     capsule that also may contain flurbiprofen or placebo. One in seven patients will receive     only placebo.      All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for     observation of bleeding and medication side effects. Patients who do not have satisfactory     pain relief from the test medicine after surgery may request a standard pain reliever. A     small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1,     2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of     33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the     day of surgery will be drawn from the catheter used to administer the sedative; the 24- and     48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be     collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.   "
163028|NCT00001725|"     This study will evaluate the safety and effectiveness of two drugs-dextromethorphan and     topiramate-in treating orofacial (mouth and face) pain. Dextromethorphan, a commonly used     cough suppressant, and topiramate, an anti-seizure medicine, block certain receptors on brain     and spinal nerve cells that may cause the cells to produce electrical discharges and pain.      Patients 18 years of age and older with oral and facial pain with trigeminal nerve damage and     who have had pain daily for at least 3 months may be eligible for this study. Candidates will     be screened with a medical history, physical examination, blood tests and psychiatric     evaluation. These results will serve as baseline values for participants. Those enrolled in     the study will take either dextromethorphan or topiramate in a 2-part study as follows:      Dextromethorphan      In Part 1, patients will take dextromethorphan and lorazepam (a commonly used anti-anxiety     drug) separately in two 6-week periods. (Lorazepam is used in this study as an active     placebo for comparison with dextromethorphan. An active placebo is a drug that does not work     for the problem being studied but whose side effects are like those of the test drug.) They     will take dextromethorphan for 4 weeks to determine the maximum tolerated dose (the highest     dose that does not cause troubling side effects) and will stay on that dose for the remaining     2 weeks. Then they will repeat this process with lorazepam. Patients who respond to either     drug may continue with Part 2 of the study, which compares these two drugs four more times to     confirm the response seen in Part 1. In Part 2, the maximum tolerated dose will be determined     in a 2-week period and that dose will be continued for another 2 weeks. This procedure will     be repeated eight times. Throughout the study, patients will keep a daily pain diary. They     will be contacted by telephone 2 to 3 times a week during dose escalation to check for side     effects. At the end of each of the two 6-week periods in Part 1 and at the end of each 4-week     period in Part 2 of the study, patients will have a 1-hour clinic visit. Participants who     live more than a few hours' drive from NIH will have a full telephone follow-up evaluation     instead of the clinic visits.      Topiramate      Patients who receive topiramate will follow a plan similar to that described above for     dextromethorphan, with the following exceptions. They will take topiramate and an inactive     placebo (a look-alike pill that has no active ingredients) in two separate 12-week periods.     Patients' maximum tolerated dose will be determined in the first 8 weeks and they will stay     on that dose for the remaining 4 weeks of each period. Patients who respond to the medication     in Part 1 may continue with Part 2 to confirm the response. Part 2 consists of six 6-week     periods. The first 4 weeks of each will be used to determine the maximum tolerated dose and     the patient will remain on that dose for the next 2 weeks. Patients will keep a daily pain     diary and will be contacted by phone 2 to 3 times a week while doses are being increased.     Patients who complete Part 2 of the topiramate study may participate in another phase of the     study that will last for 2 years. Those who continue for this phase will take topiramate for     the 2-year period. They will be followed regularly by a study nurse and will come to NIH     every 6 months for a follow-up visit.   "
163029|NCT00001726|"     This study will examine the composition of dental plaque-a naturally occurring substance that     sticks to the teeth and can cause tooth decay and gum disease. A better understanding of how     plaque builds up in the mouth may help in developing improved ways of controlling it.      Healthy normal volunteers between the ages of 18 and 65 who work at the National Institutes     of Health main campus in Bethesda, Maryland, may participate in this study. Candidates will     be screened for eligibility with a medical and dental history.      This study involves a maximum of five visits to the dental clinic. At the first visit,     participants will have a dental examination, and a mold will be made of the mouth. To make     the mold, a small plastic tray containing impression material will be placed in the     volunteer's mouth and held in place for about 2 minutes to set. The tray will then be removed     and a mold will be made from the impression. The mold will be used to make the mouthpiece     used in study 1, described below, and the tooth fittings used in study 2, also described     below. Volunteers will participate in one of these two studies.      Study 1. Volunteers in study 1 will have their mouthpiece checked at the second visit, have a     teeth cleaning, and have the mold put in place. The mouthpiece will be worn for up to 8     hours, during which time soft foods can be eaten. Mouthwash should not be used while the     device is in place. At the volunteer's third (last) visit, the mouthpiece will be removed and     the volunteer will spit into a tube to collect saliva for examination for bacteria.      Study 2. Volunteers in study 2 will have their teeth cleaned at the second visit and the     tooth fittings placed onto the back teeth with a dental adhesive. The fittings will be worn     for up to 72 hours, during which time volunteers can eat a regular diet and brush their     teeth. Mouthwash should not be used while the fittings are in place. At the third, fourth and     fifth visits, some of the fittings will be removed and, if necessary, the tooth surface will     be polished. The last of the fittings will be removed at the fifth visit and the volunteer     will spit into a tube to collect saliva for examination for bacteria.   "
163030|NCT00001727|"     Polyostotic fibrous dysplasia (PFD) is a sporadic disorder which affects multiple sites in     the skeleton. The bone at these sites is rapidly resorbed and replaced by abnormal fibrous     tissue or mechanically abnormal bone. PFD may occur alone or as part of the McCune-Albright     Syndrome (MAS), a syndrome originally defined by the triad of PFD, cafe-au-lait pigmentation     of the skin, and precocious puberty. The bony lesions are frequently disfiguring and painful,     and depending on the location of the lesion, can cause significant morbidity. Lesions in     weight-bearing bones can lead to disabling fractures, while lesions in the skull can lead to     compression of vital structures such as cranial nerves.      The natural history of this disease is poorly described and there are no clearly-defined     systemic therapies for the bone disease. The purpose of this study is to define the natural     history of the disease with or without treatment.   "
163031|NCT00001728|"     This study will evaluate the effectiveness of alendronate in treating the bone abnormality in     polyostotic fibrous dysplasia and McCune-Albright syndrome. In these diseases, areas of     normal bone are replaced with a fibrous growth similar to a scar. The weakened bone causes     pain and increases patients' risk of bone fractures and bone deformities. Alendronate belongs     to a class of drugs called bisphosphonates, which are approved by the Food and Drug     Administration to treat bone weakening, deformity and pain in other medical conditions. It is     thought that bisphosphonates might work by slowing the activity of osteoclasts-cells that     break down bone.      Patients 12 years of age and older with polyostotic fibrous dysplasia or McCune-Albright     syndrome may be eligible for this 3-year study. Candidates must also be enrolled in NIDCR's     protocol 98-D-0145 (Screening and Natural History of Patients with Polyostotic Fibrous     Dysplasia and McCune-Albright Syndrome).      Participants will be randomly assigned to one of two treatment groups: they will take one     capsule a day of either alendronate or placebo (a look-alike capsule that has no active     ingredient). They will take the capsules for 6 months, stop for 6 months, then take them for     another 6 months and then go off them for 6 months. They will then remain off the drug or     placebo for an additional 12 months and complete the study with a final follow-up visit at 36     months. While taking alendronate or placebo, patients will also take calcium and vitamin D to     prevent secondary hyperparathyroidism-a side effect of alendronate in which the bone does not     release enough calcium.      Patients will come to NIH for a physical examination and blood and urine tests every 6 months     and for monitoring of their bone disease, vision, hearing, pain levels, functional     evaluation, and photographs every 12 months. Many of the monitoring procedures, including     imaging studies and biopsies, are performed for the screening protocol (98-D-0145) and will     not be duplicated for this study. During the study periods when patients are taking     alendronate or placebo, they will have blood samples drawn by their local physician once     every 3 months and sent to NIH to check for secondary hyperparathyroidism.      If at the end of the study alendronate is found to be effective, patients who were in the     placebo treatment group will be offered alendronate for a 24-month period.   "
163033|NCT00001730|"     Thyroid cancer is typically treated with surgery, radiation or a combination of both.     Following surgical removal of thyroid tissue patients receive thyroid hormone replacement     medication. In addition patients undergo tests to determine the status of the disease. One of     the tests conducted is a whole body scan using radioactive iodine to detect and locate any     remaining cancerous thyroid tissue.      Thyroid tissue uses iodine to make thyroid hormones (T3 and T4). In order for a radioiodine     scan to work, cancerous thyroid tissue must be hungry for iodine. Thyroid stimulating     hormone (TSH) produced in the pituitary gland is responsible for making thyroid tissue     hungry for iodine. Once thyroid tissue absorbs the radioactive iodine it will be clearly     visible on the scan and can be located for removal. However, thyroid hormone replacement     medication tends to lower the activity of the pituitary gland and the amount of naturally     produced TSH. So it is necessary to stop thyroid hormone replacement to increase TSH. A     problem arises when there is a lack of thyroid hormone replacement causing patients to     experience hypothyroidism. This condition is associated with unpleasant physical and     emotional symptoms.      TSH has been created in a laboratory and called Thyrogen. It is basically the same as the TSH     produced in the human pituitary gland. However, Thyrogen increases the level of TSH in the     body without having to stop thyroid replacement medication. Therefore patients will not     experience hypothyroidism while preparing for a radioactive iodine scan.      The objective of this study is to compare the activity of radioiodine (131I) in patients     taking Thyrogen with normal thyroid activity versus patients with hypothyroid activity after     thyroid replacement medication is withdrawn. In addition the study will provide information     on how radioactive iodine is eliminated from the body. The study will help researchers     understand how to give Thyrogen and radioiodine for purposes of scanning and therapeutic     ablation (the destruction of function) of cancerous thyroid tissue.      The study will accept patients with non-medullary thyroid cancer who are preparing for     ablation therapy. The patients will be placed in one of two groups. Group one will receive     Thyrogen in 2 doses 24 hours apart. Group two will receive Thyrogen in 3 doses 72 hours     apart. The patients will undergo two 131I whole body scans: one after Thyrogen while taking     thyroid hormone suppressive and the second after withdrawal from thyroid hormone. 131I     ablative therapy will be given under hypothyroid conditions at the completion of the study.   "
163034|NCT00001731|"     This study will examine whether cyclosporin A eye drops alleviate dry eye syndrome, a     disorder of tear deficiency or excessive tear evaporation. The condition damages the surface     of the eye and causes discomfort.      Age-related dry eye syndrome may result from a problem with the immune system in which cells     called lymphocytes infiltrate the tear glands and cause a chronic, progressive inflammatory     process. Previous studies suggest that cyclosporin A may increase tear production or decrease     inflammation on the surface of the eye, or both, improving dry eye symptoms.      Patients in the study will undergo a complete eye examination, and a small tear sample will     be collected to study tear consistency and composition. A small amount of conjunctiva (the     clear, thin covering of the eye lining the eyelids and eyeball) will be removed to study     substances in it that might provide information on what causes dry eye. A blood sample also     will be taken to look for antibodies found in patients with Sjogren's syndrome, a disorder     characterized by dryness of the mouth, eyes and other mucous membranes. Patients will also     fill out forms providing information on the extent to which their dry eyes bother them.      Patients will be randomly divided into two treatment groups: one will take a cyclosporin 0.1%     eye drop emulsion; the other will take the emulsion vehicle alone-that is, the same drops but     without the active ingredient cyclosporin. Both groups will take one drop in each eye 4 times     a day for 2 months. Neither the patients nor the doctors will know which patients are     receiving which medication until the study ends. All patients will also be given artificial     teardrops to use for comfort if needed.   "
163035|NCT00001732|"     This screening protocol is designed to help recruit patients for National Eye Institute (NEI)     studies on inherited eye diseases. Patients must meet specific requirements of a research     study, and this protocol serves as a first step for admitting patients to an appropriate     program.      Candidates will undergo a medical history, physical examination, eye examination and blood     test. The eye examination includes measurement of eye pressure and dilation of the pupils to     fully examine the lens, vitreous and retina. Specialized tests will be done only if needed to     determine eligibility for a specific study in NEI's Ophthalmic Genetics Clinic. These include     routine laboratory tests, non-invasive imaging, questionnaires and other standard tests, as     well as specialized tests and procedures where needed, including genetic testing. Photographs     of the eye may be taken. Patients will be asked questions about family history, especially     relating to eye disease or cataracts, and a family tree will be drawn. A blood sample will     also be drawn.      When the screening is completed, patients will be informed of their options to participate in     a study. Patients who are ineligible for a current study will be informed of alternative     treatments or options. No treatment is offered under this protocol.   "
163036|NCT00001733|"     This screening protocol is designed to help recruit patients for National Eye Institute (NEI)     studies of the retina, such as diabetic retinopathy and macular degeneration. Patients must     meet the specific criteria of a research study, and this protocol serves as a first step for     admitting patients to a retinal disease study.      Candidates will undergo a medical history and comprehensive eye examination. The eye     examination includes dilation of the pupils to fully examine the retina. In some studies,     photographs of the eye are required. This is done using fluorescein angiography. In this     procedure, a dye called sodium fluorescein is injected into the blood stream through a vein.     After the dye reaches the blood vessels of the eye, photographs are taken of the retina.     Other diagnostic procedures may include physical examination, questionnaires, routine     laboratory tests and other standard or specialized tests, as needed.      When the screening is completed, patients will be informed of their options to participate in     a study. Patients who are ineligible for a current study will be informed of alternative     treatments or options. No treatment is offered under this protocol.   "
163037|NCT00001734|"     This screening protocol is designed to facilitate patient recruitment to National Eye     Institute (NEI) clinical research studies. Patients must meet specific requirements of a     research study; this protocol serves as a first step for admitting patients to an appropriate     program.      Candidates may have a diagnosed or undiagnosed eye condition. They will be screened with a     medical history, physical examination, eye examination and blood test. Other screening     procedures may include routine laboratory tests, non-invasive imaging, and questionnaires.     The eye examination includes measurement of eye pressure and dilation of the pupils to fully     examine the lens, vitreous and retina. Specialized eye tests will be done only if needed to     determine eligibility for a specific study. When the screening is completed, patients will be     informed of their options to participate in a study. Patients who are found ineligible for a     current study will be informed of alternative treatments or options. No treatment is offered     under this protocol.   "
163059|NCT00002682|"     RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of     the stomach. These treatments may also have an effect on gastric MALT lymphoma of the     stomach.      PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin,     clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma     of the stomach.   "
164411|NCT00004832|"     OBJECTIVES: I. Evaluate the safety and effectiveness of 3,4-diaminopyridine (DAP) in the     treatment of patients with Lambert-Eaton myasthenic syndrome (LEMS).      II. Determine the side-effects and benefits associated with DAP.   "
163038|NCT00001735|"     This study will evaluate the safety and effectiveness of gene therapy for patients with     gyrate atrophy, an inherited condition in which areas of the retina-the inner lining of the     wall of the eye-become thin. Over several decades, this degeneration of the retina causes     tunnel vision, night blindness, and other vision problems.      Gyrate atrophy is caused by a defect in the gene responsible for producing an enzyme,     ornithine aminotransferase (OAT), that breaks down an amino acid called ornithine. As a     result, excessive ornithine buildup causes the retinal thinning. Currently, this condition     can only be treated with amino acid tablets and a very low-protein diet with limited fruits     and vegetables and more than 2,000 calories a day from carbohydrates and fats. Some patients     cannot maintain this diet, and they need another treatment. One possible alternative is to     replace the defective gene with one that functions normally.      Patients who have been followed in NEI's Ocular Genetics service may be eligible to     participate in this study. Study patients will undergo the following gene therapy procedure:        1. Skin biopsy-A small piece of skin is surgically removed from the patient's thigh.        2. Gene transfer-Skin cells called keratinocytes are taken from the biopsied tissue and          grown in the laboratory. The normal gene that produces OAT is inserted into the cells,          causing them to produce more of the enzyme.        3. Skin graft-Under local anesthesia, a patch of skin about 2 1/4 inches x 2 1/4 inches is          surgically removed from the upper thigh and some of the cells with increased OAT are          grafted back onto this area.      Patients will be followed at 1 week and 2 weeks after the procedure, then monthly for 6     months, again at 9 months and 1 year. Follow-up will continue at 1-year intervals in patients     in whom the treatment is successful. During each follow-up visit patients will have 2 to 3     tablespoons of blood drawn for tests. A small biopsy (about 1/4 inch) of transplanted cells     will also be done at 1 week, 1 month, 3 months, 6 months, 1 year, and each year or so     thereafter. These tests will evaluate whether the treated skin cells are producing the     deficient OAT enzyme and, if so, how much and for how long. They will also indicate whether     the enzyme produced is sufficient to lower ornithine blood levels. Patients will also undergo     various eye examinations before grafting and at scheduled follow-up visits. These tests may     include electrophysiologic (ERG) testing, fundus photographs, scanning laser ophthalmoscope,     visual field test, fluorescein angiogram, visual acuity, and manifest reaction.   "
163039|NCT00001736|"     This study will evaluate the safety and effectiveness of a new formulation of eye drops used     to treat cystine crystals that form in the corneas of patients with cystinosis. Cystinosis is     an inherited disease caused by a defective enzyme, in which excessive amounts of the amino     acid cystine accumulate in the body. Among others, symptoms include poor growth and     development of kidney failure. In addition, after 10 to 20 years, the cornea-the outside     covering of the eye over the iris and pupils-becomes so packed with cystine crystals that     small, painful breaks may develop.      This corneal condition is treated with cysteamine eye drops. This study is designed to     provide additional information about this medication that the Food and Drug Administration     requires before approving it for marketing. The study will examine, in two separate but     simultaneous investigations, the safety and effectiveness of a new cysteamine formulation. In     both studies, before treatment begins, patients will have a complete eye examination, and     photographs of the eye will be taken using a bright flash.      Safety Study      Children and adults currently enrolled in a cystinosis study at the National Institutes of     Health may participate in this trial. They will receive the current cysteamine formulation in     one eye and the new preparation in the other eye. The drops will be given every hour during     waking hours. Patients will be observed daily for the first week of treatment and will be     called at 2 weeks and 4 weeks to check on side effects, if any. At 6 months, they will     undergo a repeat eye examination. Patients (or their parents) will keep a daily diary     recording the condition of each eye.      Effectiveness Study      Children and adults from Ann Arbor, Michigan, LaJolla, California, and the NEI clinic may be     enrolled in this study. Participants will receive medication as described above for the     safety trial. They will be observed daily for the first week and will have repeat eye     examinations, including photographs, at months 3, 6, 9 and 12 to see if the crystals have     decreased. Patients will keep a daily diary of the condition of both eyes.   "
163040|NCT00001737|"     This study will evaluate the safety and effectiveness of a sustained-release cyclosporin     implant to treat uveitis, a sight-threatening eye inflammation caused by an immune system     abnormality. Previous studies in humans have shown that, taken by mouth, the drug cyclosporin     is effective in treating chronic uveitis.      Uveitis may require long-term treatment with potent immune-suppressing drugs, such as     cyclosporin, cyclophosphamide, methotrexate, azathioprine or steroids. Taken systemically (by     mouth or injection), however, these drugs can do serious damage to the kidneys, liver or     lungs, and can raise blood pressure and lower blood cell counts. Because of this, some     patients cannot or will not use these medicines.      This small pilot study will evaluate the safety, and to some extent effectiveness, of     cyclosporin delivered directly into the eye, to try to prevent harmful side effects. In     animal studies, sustained-release cyclosporin implants did not cause the severe side effects     seen with systemic use of the drug. Some animals developed opacity of the lens and slowed     retinal responses, both of which reversed when the drug was stopped. Earlier animal studies     of cyclosporin injected directly into the eye reduced inflammation that had been produced     experimentally.      Patients with uveitis who have active inflammation and poor vision are eligible to     participate in this study. Patients will be randomly assigned to one of two treatment groups.     One group will receive a 1-mg implant that releases 0.8 micrograms of drug each day; the     second group will receive a 2-mg implant that delivers 1.4 micrograms of drug a day.      Before surgery, patients will have a medical history, basic physical examination, and     complete eye examination, including special tests called electroretinogram and fluorescein     angiography. An electroretinogram measures the electrical responses generated in the retina     in the back of the eye. Fluorescein angiography uses a special camera to photograph the     retina, showing the condition of the blood vessels in the eye.      The surgical procedure to place the implant takes about 1.5 hours and may be done under     either local or general anesthesia. Patients will stay in the hospital overnight. After     discharge from the hospital, they will return for follow-up visits 1 and 2 weeks after     surgery, then once a month for 6 months, and then every 3 months until the implant is     depleted of drug or removed. During these follow-up visits, eye examinations will be repeated     to evaluate the effects of the implant on the eye. Repeat blood tests will measure the amount     of cyclosporin in the blood and the drug's effect on the kidneys. When the implant runs out     of drug (between 2 and 3 years), it may be removed or left in place.   "
163041|NCT00001738|"     This study will look for the presence in blood of a substance called vascular endothelial     growth factor (VEGF) in patients with uveitis (eye inflammation). It will also look for this     substance in eye fluid samples taken from patients with uveitis who are undergoing eye     surgery.      Some patients with uveitis experience some vision loss during an inflammatory attack because     of swelling (edema) in a particular area of the retina called the macula, which is involved     in visual acuity. It may be that VEGF is involved in the development of macular edema.      Patients with uveitis who participate in this study will have about 10 cc (2 teaspoons) of     blood drawn to be examined for VEGF. They will also undergo a procedure called fluorescein     angiography to look at the blood vessels of the eye. A dye called sodium fluorescein is     injected into the blood stream through a vein. After the dye reaches the blood vessels of the     eye, photographs are taken of the retina.      In addition, patients with uveitis who are undergoing eye surgery will have a tissue specimen     (either aqueous fluid or vitreous gel) collected for examination for the presence of VEGF.   "
163042|NCT00001740|"     Quantitative measurements of left ventricular volume and ejection fraction are useful in the     management of patients with heart disease. Several imaging methods exist, but are limited by     cost, invasiveness, or exposure to radio-isotopes. Conventional echocardiography is a     noninvasive method that allows estimation of left ventricular size and function; however,     quantitative measurements of volume are not widely used due to lack of reproducibility and     inaccurate measurements. Real-time three-dimensional echocardiography is a new technique that     can be used to derive volume measurements from a single image acquisition. We hypothesize     that real-time three-dimensional echocardiography is an accurate method for making left     ventricular volume measurements. We therefore propose to measure left ventricular volumes     using real-time three-dimensional echocardiography in human subjects and correlate these     measurements with magnetic resonance imaging, a more accurate noninvasive method for     obtaining these measurements.   "
163064|NCT00002691|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and using drugs in different ways may     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     pediatric patients with stage III or stage IV non-Hodgkin's lymphoma.   "
163044|NCT00001742|"     A layer of cells called the endothelium line the walls of blood vessels. These cells produce     substances that control the tone of blood vessels and thus control blood flow through the     vessel. This regulating activity of the endothelium is dysfunctional in several diseases of     the heart and blood vessels, including high blood pressure and high levels of cholesterol.      Previous research has pointed toward a decrease in the action of nitric oxide (NO) as the     cause of this abnormality. Nitric oxide is a substance produced by the cells of the     endothelium that plays a role in the relaxation of blood vessels.      In this project researchers plan to study blood flow through the blood vessels in patients     forearms after receiving four different drugs: sodium nitroprusside, acetylcholine, L-NMMA,     and aspirin. These four drugs act on the blood vessels of the forearm through different     mechanisms. Acetylcholine and sodium nitroprusside are drugs that open the blood vessels of     the forearm and increase blood flow through the vessel. L-NMMA is a drug that blocks     production of nitric oxide (NO). Aspirin's role in controlling blood flow is unknown.      Patients participating in this research study will not directly benefit from it. However, the     study will contribute to researchers understanding of diseases of the blood vessels and     heart.   "
163045|NCT00001746|"     Genetically inherited heart diseases like hypertrophic cardiomyopathy (HCM) are conditions     affecting the heart passed on to family members by abnormalities in genetic information.     These conditions are responsible for many heart related deaths and illnesses.      Presently, there are several research studies being conducted in order to improve the     understanding of disease processes and symptoms associated with genetically inherited heart     diseases.      This study is designed to determine the eligibility of patients diagnosed with or suspected     to have inherited heart disease to participate in these research studies.   "
163046|NCT00001747|"     Black Americans tend to die more often from and have more diseases associated with heart     disease than White Americans. The exact cause of this is unknown, but it is likely a     combination of genetics, behavior, risk factors, strategies for education and prevention, and     socioeconomic factors.      Recent studies have suggested that faster biological processes in blood vessels of Black     Americans may be the cause of increased amounts of heart disease. In addition, small blood     vessels in Black Americans seem to be less responsive to substances that relax blood vessels,     which may explain increased blood pressure levels.      In this study researchers plan to study artery relaxation (dilation) in response substances     affecting the cells lining blood vessels (endothelin). Researchers will compare the results     of this study in black and white people to find out whether racial differences may contribute     to increases in heart disease and heart related deaths in blacks.   "
163047|NCT00001748|"     Many patients with hematological malignancies potentially curable by bone marrow     transplantation are not considered for transplantation because an HLA identical family or     unrelated donor is unavailable. For these patients the only curative option is a transplant     from a partially matched family donor. Such transplants are feasible but are less successful     than matched sibling donor transplants. The main problems with mismatched transplants are     graft rejection, graft-vs-host disease, and regimen-related mortality. This restricts the use     of mismatched transplants to patients less than 45 years at high risk of dying from the     hematological malignancy.      This protocol evaluates a new preparative regimen designed to ensure stem cell engraftment by     increased immunosuppression, followed by a G-CSF mobilized T cell depleted, stem cell rich,     peripheral blood progenitor cell (PBPC) transplant from a mismatched related donor in     patients with high risk hematological malignancies.      This phase I study evaluates engraftment and GVHD following T cell depleted, HLA-mismatched     PBPC transplants. Stopping rules will be used to make modifications to the protocol in the     event of graft failure.      The end points of the study are graft take, acute and chronic GVHD, leukemic relapse,     transplant-related mortality, death and leukemia-free survival. Patients will be followed up     for 5 years. It is planned to treat up to 35 patients aged between 10 and 45 years.   "
163048|NCT00001749|"     Diamond Blackfan anemia (DBA) is a condition in which the bone marrow is underdeveloped. DBA     is considered a congenital disease, meaning patients are born with it. In DBA there is a lack     of cells that give rise to red blood cells. The other elements produced in the bone marrow,     such as white blood cells and platelets, are normal.      Standard treatments used for this disorder such as steroids and bone marrow transplants are     associated with failure, relapse, side-effects, increased morbidity, and even death. Two     drugs, antithymocyte globulin (ATG) and cyclosporin have been used to treat DBA, but have     only provided occasional responses. No study has ever combined these two drugs for the     treatment of DBA.      This study is designed to explore the combined use of ATG and cyclosporine as a rational     approach to the treatment of DBA.   "
163049|NCT00001750|"     Some drugs have the ability to push stem cells (the cells responsible for producing new cell     types) out of the bone marrow and into the blood stream. The steps involved in this process     are still poorly understood. However, a better understanding of this process could lead to     improved results in transplantation, cancer treatment, and contribute to the development of     new genetic therapies for a wide variety of disorders.      In this study researchers plan to compare two different treatments, both that mobilize (push)     stem cells out of the bone marrow into the blood stream. In addition, researchers will     attempt to determine which is the most efficient at mobilizing blood cells of patients with     multiple myeloma.      Information and knowledge gained from this study will help to design future transplantation     and genetic therapy research studies.   "
168546|NCT00034593|"     Definition: Patients with bladder cancer will be participating in this study for the     treatment of abnormal cells in the bladder that have returned after initial treatment OR have     moved to a new site in the body.   "
163050|NCT00001752|"     Estrogen therapy has been associated with reduced risk of coronary heart disease events in     observational studies of postmenopausal women. Although favorable effects of estrogen on     lipoprotein cholesterol levels probably account for much of this benefit, direct vascular     effects (vasomotor, hemostatic, anti-inflammatory) regulated by nitric oxide (NO) may also be     of importance. We have recently shown that vasodilator effects of estrogen in the coronary     circulation are due to enhanced bioactivity of NO released from the endothelium. Estrogen has     been shown to stimulate synthesis and activity of the enzyme NO synthase with enhanced NO     synthesis in endothelial cells in culture. Because L-arginine is the natural substrate for     the enzyme NO synthase, we propose that the combination of L-arginine and estrogen might have     additive vasomotor, hemostatic and anti-inflammatory effects in hypercholesterolemic     postmenopausal women.   "
163052|NCT00001754|"     This study will determine the genes responsible for skeletal dysplasias (disorders of the     skeleton) and short stature and define the range and type of medical problems they cause over     time. It will investigate whether specific gene changes cause specific medical problems in     these disorders and identify the signs and symptoms upon which their diagnoses must be based.      Individuals with short stature or with a skeletal dysplasia known or suspected to be caused     by a gene mutation (change) may be eligible for this study. Family members may also     participate. Skeletal dysplasias under study include: achondroplasia, hypochondroplasia,     achondrogenesis type II, hypochondrogenesis, Kniest dysplasia, spondyloepiphyseal dysplasias,     Stickler syndrome; Shmid and Jansen metaphyseal dysplasias; pyknodysotosis, proximal     symphalangism, brachydactyly types B C and E, Ellis van Creveld and related disorders,     metatrophic chondrodysplasias, cartilage-hair hypoplasia and disorders with a skeletal     abnormality that have not yet been defined but might be the result of a genetic defect.      Patients will talk with two genetics specialists who will explain the study and its possible     implications for the patient and family and answer questions. The patient's medical records     will be reviewed, a personal and family history will be taken, and a physical examination     will be done. Various other procedures that may be done include drawing up to 6 tablespoons     of blood, some of which will be used for DNA (genetic) studies, X-rays, echocardiography     (ultrasound of the heart), magnetic resonance imaging (MRI), eye examination, hearing test,     sleep study, sperm analysis and skin biopsy (surgical removal of a small piece of skin done     under local anesthetic). There may be additional evaluations by specialists in rheumatology,     rehabilitation medicine and orthopedics. When the tests and examinations are completed (after     2 to 3 days), a doctor will discuss the results with the patient. Patients whose DNA studies     show that a gene change is responsible for their disorder will meet with a genetics nurse or     counselor to review the results, express their feelings and ask any questions they may have.     Patients may be asked to return to NIH every 6 months to 2 years for continued follow-up.     Medical management will be provided primarily by the patient's own physician.      Participating family members will be interviewed by telephone about their personal and family     health history and will have a blood sample drawn for DNA testing. If a gene change is found     that is responsible for the bone disorder or growth problem in the family, arrangements will     be made for the family member to discuss the implications of the findings with a genetics     specialist.   "
163053|NCT00001756|"     This study will investigate mast cell precursors that circulate in the blood. In a group of     diseases collectively known as mastocytosis, mast cells accumulate in abnormal amounts in the     skin, lymphoid tissues, bone marrow, liver and spleen. Some forms of mastocytosis have a     generally good prognosis; for others, the prognosis is poorer. There is no known cure for any     form of the disease. A better understanding of mast cells and how they respond to certain     substances may provide insights that will lead to effective treatments for mastocytosis.      Patients with systemic mastocytosis and normal healthy volunteers between the ages of 20 and     60 may be eligible for this 8-day study. Participants will undergo the following procedures:        -  Day 1 Medical history, physical examination, and blood tests to assess general health          status        -  Days 2 through 6 Daily injections under the skin of G-CSF a hormone that stimulates          white blood cell production        -  Day 7 Leukapheresis a procedure for collecting large numbers of white blood cells. In          leukapheresis, blood is drawn through a needle placed in an arm and channeled into a          cell separator machine. The white cells are collected and the rest of the blood is          returned to the body through a needle in the other arm. The procedure takes up to 3          hours.        -  Days 7 and 8 Blood draw (about 1 teaspoon) to monitor white blood cell counts.   "
163054|NCT00002677|"     Phase I trial to study the effectiveness of tributyrin in treating patients with refractory     stage IV prostate cancer or other solid tumors. Drugs used in chemotherapy use different ways     to stop tumor cells from dividing so they stop growing or die.   "
163055|NCT00002678|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is most effective in treating patients with     multiple myeloma.      PURPOSE: Randomized phase III trial to compare the effectiveness of various combination     chemotherapy regimens in treating patients with multiple myeloma.   "
163056|NCT00002679|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose sequential chemotherapy as     adjuvant therapy in treating patients with stage II or stage III breast cancer who have four     or more positive axillary lymph nodes.   "
163057|NCT00002680|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of sequential high-dose chemotherapy     followed by peripheral stem cell transplantation in treating patients with metastatic breast     cancer that is responding to chemotherapy.   "
163058|NCT00002681|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a     person's white blood cells to kill leukemia or lymphoma cells. Combining these two therapies     may be an effective treatment for leukemia and lymphoma.      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy plus     interleukin-2 in treating patients who have leukemia or lymphoma.   "
163259|NCT00002938|"     RATIONALE: Prostatectomy may be an effective treatment for prostate cancer that has not     responded to radiation therapy.      PURPOSE: This phase II trial is studying how well prostatectomy works in treating patients     with recurrent or persistent prostate cancer that has not responded to radiation therapy.   "
163066|NCT00002693|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with     carboplatin and topotecan in treating patients with chronic myelogenous leukemia or recurrent     acute leukemia.   "
163067|NCT00002695|"     RATIONALE: Diagnostic procedures, such as analysis of tumor tissue and lymph nodes that have     been surgically removed, may improve the treatment of patients with cancers of the head and     neck.      PURPOSE: Diagnostic trial to determine if analyzing tumor tissue and lymph nodes surgically     removed from patients with cancers of the head and neck can predict recurrence of the cancer.   "
163068|NCT00002696|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare cyclophosphamide, doxorubicin, and     fluorouracil with cyclophosphamide, methotrexate, and fluorouracil in treating women with     stage III breast cancer.   "
163084|NCT00002721|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus estramustine in     treating patients with metastatic recurrent prostate cancer that does not respond to hormone     therapy.   "
163070|NCT00002700|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor     cells. Bone marrow transplantation can replace immune cells that were destroyed by     chemotherapy.      PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with     or without bone marrow transplantation in treating patients with acute lymphoblastic     leukemia.   "
163071|NCT00002701|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Bone marrow transplantation may be able to replace immune cells     that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of     combination chemotherapy with or without bone marrow transplantation is more effective in     treating promyelocytic leukemia      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination     chemotherapy regimens with or without bone marrow transplantation in treating patients who     have promyelocytic leukemia.   "
163072|NCT00002702|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells of     the mouth or oropharynx. Radiation therapy uses high-energy x-rays to damage tumor cells. It     is not known whether giving interleukin-2 with surgery and radiation therapy is more     effective than surgery and radiation therapy alone.      PURPOSE: This randomized phase III trial is studying surgery and radiation therapy alone to     see how well they work compared to surgery, radiation therapy, and interleukin-2 in treating     patients with cancer of the mouth or oropharynx.   "
163073|NCT00002703|"     RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of conventional radiation     therapy with high-dose radiation therapy in treating men with stage I or stage II prostate     cancer.   "
163074|NCT00002704|"     Phase II trial to study the effectiveness of radiation therapy following chemotherapy in     treating children with CNS relapse from acute lymphoblastic leukemia. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Combining chemotherapy with radiation therapy may kill more cancer cells.   "
163075|NCT00002705|"     Phase I trial to study the effectiveness of topotecan in treating children with refractory     leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so     they stop growing or die.   "
163076|NCT00002706|"     This randomized phase III trial is studying laparoscopic surgery to see how well it works     compared to standard surgery in treating patients with endometrial cancer or cancer of the     uterus. Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and     may have fewer side effects and improve recovery. It is not known whether laparoscopic     surgery is more effective than standard surgery in treating endometrial cancer.   "
163077|NCT00002707|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if chemotherapy given before surgery is more     effective with or without docetaxel given before or after surgery for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy using     doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage     II or stage III breast cancer.   "
163078|NCT00002708|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known whether giving radiation therapy during surgery is more effective than standard     radiation therapy in treating brain metastases.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without radiosurgery in treating patients with brain metastases that cannot be removed during     surgery.   "
163079|NCT00002711|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and radiation     therapy in treating patients with cancer of the esophagus.   "
163080|NCT00002717|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which chemotherapy regimen is more effective for ovarian or peritoneal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of     paclitaxel plus cisplatin in treating patients who have residual disease after surgery to     remove stage III or stage IV ovarian cancer or primary peritoneal cancer.   "
163128|NCT00002779|"     RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop cancer     cells from dividing so they stop growing or die. Combining more than one drug may kill more     cancer cells.      PURPOSE: Phase II trial to study the effectiveness of fludarabine plus octreotide in treating     patients who have relapsed low-grade non-Hodgkin's lymphoma.   "
163081|NCT00002718|"     RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune     cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of T-cell depleted bone marrow and G-CSF     stimulated peripheral stem cell transplantation in treating patients with leukemia,     lymphoblastic lymphoma, myelodysplastic syndrome, or aplastic anemia.   "
163082|NCT00002719|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number     of immune cells found in the bone marrow or peripheral blood and may help a person's immune     system recover after chemotherapy and radiation therapy. Combining more than one drug and     giving drugs in different ways may kill more cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without G-CSF in treating older patients with acute myeloid leukemia.   "
163083|NCT00002720|"     RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women     with breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without     axillary lymph node dissection following quadrantectomy in treating older women with stage I     breast cancer that is estrogen receptor positive.   "
164444|NCT00004872|"     RATIONALE: Endostatin may stop the growth of solid tumors by stopping blood flow to the     tumor.      PURPOSE: Phase I trial to study the effectiveness of endostatin in treating patients who have     advanced refractory solid tumors.   "
163086|NCT00002723|"     Randomized phase III trial to compare the effectiveness of low, intermediate, and high dose     suramin in treating men with stage IV prostate cancer that is refractory to hormone therapy.     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. It is not yet known which regimen of suramin is more effective for prostate     cancer.   "
163087|NCT00002725|"     Phase II trial to study the effectiveness of bryostatin-1 in treating patients with recurrent     non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells     from dividing so they stop growing or die.   "
163088|NCT00002727|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known which radiation therapy regimen is more effective in treating patients with stage II     cancer of the vocal cord.      PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating     patients who have stage II cancer of the vocal cord.   "
163089|NCT00002730|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining     buthionine sulfoximine with chemotherapy may reduce resistance to the drug and allow more     tumor cells to be killed.      PURPOSE: Phase I trial to study the effectiveness of melphalan, buthionine sulfoximine, and     G-CSF in treating children with progressive neuroblastoma that has not responded to previous     therapy.   "
163090|NCT00002733|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Combining different types of biological therapies, including     interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, may kill more cancer     cells.      PURPOSE: Phase II trial to study the effectiveness of biological therapies, including     interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, in treating patients with     metastatic cancer.   "
163091|NCT00002734|"     Phase I trial to study the effectiveness of radiolabeled monoclonal antibody, paclitaxel, and     interferon alfa in treating patients who have ovarian cancer. Radiolabeled monoclonal     antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to     them without harming normal cells. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Interferon may interfere with the     growth of cancer cells. Combining monoclonal antibody, chemotherapy, and interferon alfa may     kill more tumor cells.   "
163092|NCT00002735|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation     therapy in treating patients with stage III or stage IV cancer of the hypopharynx or tongue.   "
163093|NCT00002737|"     RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the     growth of kidney cancer. Isotretinoin may help kidney cancer cells develop into normal cells.     It is not yet known whether interferon alfa plus isotretinoin is more effective than     interferon alfa alone for kidney cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or     without isotretinoin in treating patients who have metastatic kidney cancer.   "
163094|NCT00002738|"     RATIONALE: Drugs used in chemotherapy, such as trimetrexate glucuronate and leucovorin, use     different ways to stop cancer cells from dividing so they stop growing or die. Combining more     than one drug may kill more cancer cells.      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating     children with recurrent acute lymphoblastic leukemia, recurrent osteosarcoma, or refractory     non-Hodgkin's lymphoma.   "
163095|NCT00002740|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may allow doctors to give     higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses     high-energy x-rays to damage tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral     stem cell transplantation followed by surgery and/or radiation therapy in treating young     patients who have newly diagnosed advanced neuroblastoma.   "
168630|NCT00035724|"     To examine temporal trends from 1995 and 2000 in the incidence rates of heart failure, its     therapeutic management, and changes over time in the hospital and long-term survival of     patients with heart failure.   "
163096|NCT00002742|"     RATIONALE: Antifungal therapy with liposomal nystatin may reduce fever and neutropenia in     patients undergoing treatment for hematologic cancer. It is not yet known whether liposomal     nystatin is more effective than standard amphotericin B in treating patients with fever and     neutropenia who are receiving chemotherapy for hematologic cancer or bone marrow     transplantation for leukemia.      PURPOSE: Randomized phase III trial to study the effectiveness of liposomal nystatin compared     with standard amphotericin B to treat fever and neutropenia in patients receiving     chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.   "
163097|NCT00002744|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug and giving them in different ways     may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is     more effective for acute lymphoblastic leukemia      PURPOSE: Randomized phase III trial to compare different regimens of combination chemotherapy     in treating children who have newly diagnosed acute lymphoblastic leukemia.   "
163098|NCT00002745|"     Phase II trial to study the effectiveness of aminocamptothecin in treating patients who have     refractory or recurrent Hodgkin's disease or non-Hodgkin's lymphoma. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die.   "
163099|NCT00002746|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients with     myelodysplastic syndrome.   "
163145|NCT00002800|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose cytarabine plus idarubicin in     treating patients with newly diagnosed acute or chronic myelogenous leukemia or     myelodysplastic syndrome.   "
163100|NCT00002747|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It     is not yet known if surgery plus radiation therapy is more effective with or without     chemotherapy for treating mouth cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery and radiation     therapy with or without chemotherapy in treating patients with stage II, stage III, or stage     IV mouth cancer.   "
163101|NCT00002748|"     RATIONALE: Inserting the gene for interleukin-2 into a person's neuroblastoma cells may make     the body build an immune response and kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of using interleukin-2 gene-modified     neuroblastoma cells in treating children who have refractory or recurrent neuroblastoma.   "
163102|NCT00002749|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of carboplatin in patients with     progressive glioma.   "
163103|NCT00002750|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of melphalan in patients with persistent or     recurrent neoplastic meningitis.   "
163104|NCT00002751|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in     treating patients who have brain metastases.   "
163105|NCT00002752|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody     therapy in treating patients who have primary or metastatic brain cancer.   "
163106|NCT00002753|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to determine the effectiveness of monoclonal antibody in treating     patients with recurrent gliomas.   "
163107|NCT00002754|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to determine the effectiveness of monoclonal antibody therapy in     treating patients who have primary or metastatic melanoma or brain tumors.   "
163108|NCT00002755|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may allow doctors to give     higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which     treatment regimen is more effective for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of standard     cyclophosphamide, methotrexate, and fluorouracil with that of high-dose combination     chemotherapy plus peripheral stem cell transplantation in treating women who have stage II or     stage IIIA breast cancer.   "
163109|NCT00002756|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from     dividing so they stop growing or die. Combining more than one chemotherapy drug and giving     them as induction intensification may kill more cancer cells.      PURPOSE: This phase II trial is studying how well induction intensification works in treating     infants with newly diagnosed acute lymphocytic leukemia.   "
163110|NCT00002757|"     RATIONALE: Less intensive therapy may attain in the same results as intensive therapy in     children with non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to study the effectiveness of less intensive therapy for     children who have non-Hodgkin's lymphoma.   "
163111|NCT00002759|"     Phase I trial to study the effectiveness of irinotecan plus cyclosporine and phenobarbital in     treating patients who have solid tumors or lymphoma that is refractory to standard therapy.     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Cyclosporine and phenobarbital may enhance the effectiveness of irinotecan.   "
163112|NCT00002760|"     RATIONALE: Antiandrogen withdrawal may be an effective treatment for prostate cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of ketoconazole and     hydrocortisone for antiandrogen withdrawal in treating men with prostate cancer that is     refractory to hormone therapy.   "
163113|NCT00002761|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by     peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.   "
163115|NCT00002763|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not known     whether giving high-dose or low-dose interferon alfa is more effective than no further     therapy in treating patients with stage III melanoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of high- or low-dose     interferon alfa with that of no further therapy following surgery in treating patients who     have stage III melanoma.   "
163116|NCT00002764|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether surgery plus combination chemotherapy is more effective than surgery alone     in treating patients with lung metastases from soft tissue sarcoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination     chemotherapy with that of surgery alone in treating patients who have soft tissue sarcoma     that has spread to the lung.   "
163117|NCT00002765|"     RATIONALE: Immunotoxins can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of LMB-2 immunotoxin in treating patients     who have leukemia or lymphoma.   "
163159|NCT00002816|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy in treating     children who have relapsed acute lymphoblastic leukemia.   "
163118|NCT00002766|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic     leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.      PURPOSE: This randomized phase III trial is studying two different chemotherapy regimens and     comparing them to see how well they work in treating adults with acute lymphoblastic     leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.   "
163119|NCT00002767|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells.Vaccines may make     the body build an immune response to kill tumor cells. It is not yet known whether melanoma     vaccine plus interferon alfa is more effective than interferon alfa alone in treating     patients with metastatic melanoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or     without vaccine therapy in treating patients with metastatic melanoma.   "
163120|NCT00002768|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation     following chemotherapy in treating patients with acute myeloid leukemia in second remission.   "
163121|NCT00002771|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of various combination     chemotherapy regimens or bone marrow transplantation in treating patients with chronic     myelogenous leukemia.   "
163122|NCT00002772|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give     higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which     regimen of chemotherapy followed by peripheral stem cell transplantation is more effective     for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     plus peripheral stem cell transplantation in treating women who have undergone surgery for     breast cancer.   "
163123|NCT00002773|"     RATIONALE: Vaccines made from donated tumor cells treated with interferon alfa may make the     body build an immune response to and kill pancreatic tumor cells. Drugs used in chemotherapy     use different ways to stop tumor cells from dividing so they stop growing or die.     Colony-stimulating factors may help a person's immune system recover from the side effects of     chemotherapy. Combining these treatments may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy using donated     tumor cells treated with interferon alfa and radiation therapy and cyclophosphamide plus     GM-CSF in treating patients with advanced pancreatic cancer.   "
163124|NCT00002774|"     PURPOSE: Randomized phase 2 trial to compare the effectiveness of chemo-radiation therapy (RT     + cisplatin + 5-FU) with or without tirapazamine for the treatment of patients with stage III     or IV squamous cell carcinomas of the head and neck cancer (SCCHN).      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation     therapy uses high-energy x-rays to damage tumor cells.      Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making     tumor cells more sensitive to therapy.   "
163125|NCT00002775|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel and estramustine     in treating patients who have metastatic prostate cancer.   "
163126|NCT00002777|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen.      PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that     of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast     cancer.   "
163127|NCT00002778|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from     dividing so they stop growing or die. Combining chemotherapy with allogeneic bone marrow     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     cancer cells. Colony-stimulating factors such as sargramostim may increase the number of     immune cells found in bone marrow or peripheral blood, and may help a person's immune system     recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation     followed by sargramostim in treating patients who have chronic myelogenous leukemia.   "
163260|NCT00002939|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of irinotecan and paclitaxel in treating     patients with metastatic or recurrent cancer.   "
163129|NCT00002780|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Combining different types of biological therapies may kill more     tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of T cells and interleukin-2 combined     with peripheral stem cell transplantation or bone marrow transplantation in treating women     who have stage IIIB or metastatic breast cancer.   "
163130|NCT00002781|"     RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming     normal tissue.      PURPOSE: Phase I trial to study the effectiveness of boron neuron capture therapy in treating     patients with stage III melanoma.   "
163131|NCT00002783|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving them in different ways may     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy before and after surgery     in treating patients with high-risk stomach cancer.   "
174331|NCT00122928|"     The purpose of this study is to design and demonstrate the feasibility of implementing     moderate and intensive environmental obesity prevention programs at major worksites.   "
163132|NCT00002784|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It     is not yet known if high-dose combination chemotherapy plus peripheral stem cell     transplantation is more effective than standard combination chemotherapy for breast cancer.      PURPOSE: Randomized phase III trial to compare high-dose combination chemotherapy plus     peripheral stem cell transplantation with standard combination chemotherapy in treating women     with stage II or stage III breast cancer.   "
163133|NCT00002785|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. Bone     marrow transplantation may allow the doctor to give higher doses of chemotherapy and kill     more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, bone marrow     transplantation, and radiation therapy in treating infants with acute lymphoblastic leukemia.   "
163134|NCT00002786|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing.      PURPOSE: Phase I/II trial to study the effectiveness of biological therapy in treating     patients who have metastatic melanoma.   "
163135|NCT00002787|"     The purpose of this trial is to test the safety and immune response to four immunizations     with this vaccine made from a protein produced by the patient's tumor. There is no guarantee     or promise that this procedure will be successful   "
163136|NCT00002788|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of high-dose combination chemotherapy     followed by total-body irradiation and peripheral stem cell transplantation in treating     patients with chronic lymphocytic leukemia.   "
163137|NCT00002789|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell or bone marrow transplantation may be able     to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.     Sometimes the transplanted cells can make an immune response against the body's normal     tissues. Stem cells that have been treated in the laboratory with filgrastim may prevent this     from happening. Combining chemotherapy with bone marrow or peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     cancer cells. It is not yet known which treatment is more effective for chronic myeloid     leukemia.      PURPOSE: Randomized phase III trial to compare the effectiveness of donor peripheral stem     cell transplantation with donor bone marrow transplantation in treating patients with chronic     myeloid leukemia.   "
163138|NCT00002790|"     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were     destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make     an immune response against the body's normal tissues. Treatment with sirolimus, methotrexate,     and cyclosporine may prevent this from happening.      PURPOSE: Phase I/II trial to study the effectiveness of sirolimus plus methotrexate and     cyclosporine in preventing graft-versus-host disease in patients with hematologic     malignancies who are receiving a bone marrow transplant.   "
163139|NCT00002791|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with more than one chemotherapy drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation     therapy followed by surgery in treating patients who have soft tissue sarcoma.   "
163140|NCT00002792|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with     chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either     bone marrow or peripheral stem cell transplantation in treating patients with     myeloproliferative disorders.   "
163141|NCT00002793|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug or giving the drugs in different ways     may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy administered     via an implantable pump with a subcutaneous port for unresectable liver metastases in     patients with resected primary colorectal cancer.   "
163142|NCT00002794|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of carboplatin plus vincristine in     treating children with retinoblastoma.   "
163261|NCT00002940|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients with     Epstein-Barr virus-associated primary CNS lymphoma and AIDS.   "
163143|NCT00002796|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Interferon-gamma may interfere with the growth of tumor cells and slow the     growth of the tumor. Combining more than one drug with interferon-gamma may kill more tumor     cells. This phase I/II trial is studying the side effects and best dose of giving     fluorouracil together with phenylbutyrate, indomethacin, and interferon-gamma and to see how     well it works in treating patients with stage IV colorectal cancer   "
163144|NCT00002798|"     Randomized phase III trial to compare the effectiveness of different chemotherapy regimens     with or without bone marrow transplantation in treating children who have acute myelogenous     leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop     cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone     marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and     kill more cancer cells. It is not yet known which treatment regimen is more effective for     acute myelogenous leukemia or myelodysplastic syndrome   "
163146|NCT00002801|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and combining radiation therapy with     chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of     fluorouracil-uracil and leucovorin plus radiation therapy in treating patients with     colorectal cancer who have undergone surgery to remove the tumor.   "
163147|NCT00002802|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow     the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation     therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment     regimen is most effective in treating patients with different stages of and risk factors for     neuroblastoma.      PURPOSE: Phase III trial to study the effectiveness of therapy based on stage of disease and     risk assessment in treating children with neuroblastoma.   "
163148|NCT00002803|"     RATIONALE: Sometimes neuroblastoma will regress without treatment, but sometimes additional     treatment may be necessary. Giving more than one chemotherapy drug after surgery to remove     the tumor may kill more tumor cells.      PURPOSE: Phase II trial to study combination chemotherapy or observation following surgery in     treating infants with neuroblastoma.   "
163149|NCT00002804|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, surgery, and     radiation therapy in treating children who have advanced soft tissue sarcoma.   "
163150|NCT00002805|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did     not achieve first remission.   "
163151|NCT00002806|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of procarbazine, lomustine, and     vincristine followed by radiation therapy in treating adults who have supratentorial glioma.   "
163152|NCT00002807|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet     known whether radiation therapy is more effective than observation only after sugery in     treating endometrial cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works compared to observation only in treating patients with stage I or stage II endometrial     cancer who have undergone hysterectomy and oophorectomy.   "
163153|NCT00002809|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Combining chemotherapy and radiation therapy together with bone marrow transplant may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bone marrow transplant from an     unrelated donor together with cyclophosphamide and total-body irradiation works in treating     patients with hematologic cancer.   "
163154|NCT00002810|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma     cells, either by killing the cells or by stopping them from dividing. Having a peripheral     stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows     higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing     the number of plasma cells, the disease may progress more slowly.      PURPOSE: This phase II trial is studying how well giving high-dose melphalan together with     peripheral stem cell transplant works in treating patients with primary amyloidosis or     amyloidosis associated with multiple myeloma.   "
163155|NCT00002811|"     RATIONALE: Patients with xeroderma pigmentosum are more likely to develop skin lesions in     sun-affected areas. These skin lesions, such as actinic keratoses, can develop into skin     cancer. T4N5 liposome lotion may reduce actinic keratoses or other sun-induced skin damage in     patients with xeroderma pigmentosum.      PURPOSE: Randomized double-blinded phase III trial to compare treatment using T4N5 liposome     lotion with treatment using placebo in reducing actinic keratoses and other sun-induced skin     damage in patients with xeroderma pigmentosum.   "
163187|NCT00002850|"     RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection     in patients with multiple myeloma and may improve their response to chemotherapy.      PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work     compared to no antibiotics in preventing early infection in patients with multiple myeloma.   "
163156|NCT00002812|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug and giving the drugs in different     combinations may kill more cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination     chemotherapy treatment with more intensive combination chemotherapy in treating children with     acute lymphocytic leukemia.   "
163157|NCT00002813|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin     and vinorelbine in treating patients with refractory or recurrent squamous cell cervical     cancer that has not responded to local therapy.   "
163158|NCT00002814|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy using     paclitaxel and topotecan, plus G-CSF, in treating patients with glioblastoma multiforme or     anaplastic astrocytoma that is refractory or recurrent.   "
163160|NCT00002817|"     RATIONALE: Vaccines may make the body build an immune response to kill melanoma cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients     with metastatic melanoma.   "
163161|NCT00002818|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Deoxycytidine may protect patients from the side effects of     high-dose cytarabine.      PURPOSE: Phase I trial to study the effectiveness of high-dose cytarabine given with     deoxycytidine in treating patients who have refractory acute myelogenous leukemia or other     lymphoma or leukemia.   "
163162|NCT00002819|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune     cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It     is not yet known whether chemotherapy alone is more effective than chemotherapy plus     peripheral stem cell transplantation for ovarian epithelial cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and     carboplatin with that of carboplatin, mitoxantrone, and cyclophosphamide followed by     peripheral stem cell transplantation in treating patients who have persistent stage III or     stage IV ovarian epithelial cancer.   "
163163|NCT00002822|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug is a way to kill more tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effect of two combination chemotherapy     regimens followed by radiation therapy in treating patients with small cell lung cancer.   "
163164|NCT00002823|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if combination chemotherapy given after surgery     is more effective than surgery alone for non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     following surgery with that of surgery alone in treating patients who have stage I, stage II,     or stage IIIA non-small cell lung cancer.   "
163165|NCT00002824|"     RATIONALE: Inserting the gene for herpes virus into a person's cells may improve the body's     ability to fight cancer or make the cancer more sensitive to chemotherapy using antiviral     drugs such as ganciclovir.      PURPOSE: Phase I trial to study the effectivenesss of gene therapy in treating patients with     primary brain tumors.   "
163166|NCT00002825|"     Phase II trial to study the effectiveness of docetaxel in treating children with recurrent     solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing     so they stop growing or die.   "
163167|NCT00002826|"     RATIONALE: Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with a     chemotherapy drug may reduce resistance to the drug, and allow the tumor cells to be killed.      PURPOSE: Phase II trial to study the effectiveness of PSC 883 and paclitaxel in treating     women who have recurrent or metastatic breast cancer.   "
163168|NCT00002827|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not     yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's     disease.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy,     with or without dexrazoxane, followed by radiation therapy in treating young patients with     newly diagnosed stage I, stage II, or stage III Hodgkin's disease.   "
163169|NCT00002828|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of raltitrexed and fluorouracil in treating     patients who have colorectal cancer that is metastatic, recurrent, or cannot be surgically     removed.   "
163170|NCT00002829|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells, and may be an effective treatment for lymphoma. Bone marrow transplantation may be     able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to     kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating     patients with recurrent or residual low-grade lymphoma.   "
163171|NCT00002831|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus     peripheral stem cell transplantation in treating patients with chronic myelogenous or acute     leukemia.   "
163172|NCT00002832|"     RATIONALE: Peripheral stem cell transplantation may be an effective treatment for leukemia,     myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed following bone     marrow transplantation.      PURPOSE: Phase I/II trial to study the effectiveness of decitabine and peripheral stem cell     transplantation in treating patients who have leukemia, myelodysplastic syndrome, or chronic     myelogenous leukemia that has relapsed after bone marrow transplantation.   "
163173|NCT00002833|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.     Colony stimulating factors such as filgrastim may increase the number of immune cells found     in bone marrow or peripheral blood and may help a person's immune system recover from the     side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation     plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.   "
163174|NCT00002835|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of     combination chemotherapy in treating patients who have intermediate-grade or immunoblastic     lymphoma.   "
163716|NCT00002986|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of topotecan plus carmustine in patients     with recurrent primary malignant glioma.   "
163175|NCT00002836|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy. Peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus     filgrastim with filgrastim alone in treating women undergoing peripheral stem cell     transplantation for stage II, stage III, or metastatic breast cancer.   "
163176|NCT00002837|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining peripheral stem cell transplantation with chemotherapy     may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of high-dose combination chemotherapy     and peripheral stem cell transplantation in treating patients with recurrent or metastatic     breast cancer.   "
163177|NCT00002838|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy and kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus     peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic     leukemia.   "
163178|NCT00002839|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to     preserve the part of the body where the cancer started. It is not yet known which regimen of     cisplatin and fluorouracil combined with radiation therapy is more effective in treating     resectable cancer of the hypopharynx or larynx.      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of cisplatin     and fluorouracil combined with radiation therapy in preserving the larynx in patients who     have resectable cancer of the hypopharynx or larynx.   "
163179|NCT00002840|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, and may be an     effective treatment for anaplastic oligodendroglioma. Combining combination chemotherapy with     radiation therapy may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare radiation therapy with and without combination     chemotherapy in patients with resected anaplastic oligodendroglioma.   "
163180|NCT00002842|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving drugs in different ways may     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of surgery followed by floxuridine plus     systemic fluorouracil and leucovorin in treating patients with liver metastases from     colorectal cancer.   "
163181|NCT00002844|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating     patients with chronic lymphocytic leukemia.   "
163182|NCT00002845|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who     have metastatic melanoma.   "
163183|NCT00002846|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer     cells.      PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating     patients with metastatic or recurrent kidney cancer.   "
163184|NCT00002847|"     RATIONALE: Biological therapies use different ways to stimulate the immune system to try to     stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in     treating patients with metastatic kidney cancer.   "
163185|NCT00002848|"     RATIONALE: Developing coping strategies may help improve the quality of life of patients with     prostate cancer.      PURPOSE: This randomized clinical trial is comparing the effect of group therapy with written     educational materials on the quality of life of men with stage I or stage II prostate cancer.   "
163186|NCT00002849|"     RATIONALE: Chemotherapy plus interferon alfa may be effective for primary systemic     amyloidosis.      PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus interferon alfa in     treating patients who have primary systemic amyloidosis.   "
168631|NCT00035737|"     To investigate the role of endothelial dysfunction and increased vascular stiffness as     contributors to the pathogenesis of cardiovascular disease.   "
163189|NCT00002852|"     Randomized phase III trial to compare the effectiveness of surgery with or without     combination chemotherapy in treating patients who have stage I non-small cell lung cancer.     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining more than one drug may kill more tumor cells. It is not yet known     whether surgery is more effective with or without chemotherapy for non-small cell lung     cancer.   "
163190|NCT00002854|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give     higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral     stem cell transplantation in treating patients who have advanced cancer.   "
163191|NCT00002855|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining hormone therapy with chemotherapy and androgen     suppression may kill more tumor cells. It is not yet known which treatment regimen is more     effective for prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone     therapy versus androgen suppression alone as initial therapy in patients with prostate cancer     that is metastatic or that cannot be removed surgically.   "
179155|NCT00180076|"     The purpose of this study is to determine whether orale budesonide is effective in     maintaining clinical remission in patients with collagenous colitis.   "
163192|NCT00002858|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.     It is not yet known which treatment regimen is more effective for small cell lung cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy     using two different doses of cyclophosphamide followed by alternating chemotherapy and     radiation therapy in treating patients with small cell lung cancer.   "
163193|NCT00002860|"     RATIONALE: Surgery may be effective therapy in treating patients with metastatic melanoma.      PURPOSE: This phase II trial is studying how well surgery works in treating patients with     metastatic melanoma.   "
163194|NCT00002862|"     Phase I trial to study the effectiveness of perillyl alcohol in treating patients with     refractory cancer. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die.   "
163195|NCT00002863|"     RATIONALE: Cryosurgery kills cancer cells by freezing them. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     cryosurgery with chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of cryosurgery with or without chemotherapy     in treating patients who have soft tissue sarcoma.   "
163196|NCT00002864|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen with or without octreotide may fight breast cancer by blocking the uptake of     estrogen. It is not yet known which treatment regimen is more effective for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without     octreotide in treating postmenopausal women who have stage I, stage II, or stage III breast     cancer.   "
163197|NCT00002865|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of high-intensity, brief-duration     chemotherapy in treating patients with relapsed or refractory acute lymphocytic leukemia.   "
163198|NCT00002866|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of     immune cells found in bone marrow or peripheral blood and may help a person 's immune system     recover from the side effects of chemotherapy.      PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and epirubicin with and     without G-CSF in treating women with metastatic breast cancer.   "
163199|NCT00002868|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Combining interferon alfa with high-dose chemotherapy and peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or     without peripheral stem cell transplantation in treating patients who have newly diagnosed     chronic myelogenous leukemia in chronic phase.   "
163200|NCT00002869|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Low doses of     interferon alfa may be as effective as high doses.      PURPOSE: Randomized phase III trial to compare the effectiveness of low-dose or high-dose     interferon alfa in treating patients who have newly diagnosed chronic myelogenous leukemia.   "
163201|NCT00002870|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. It     is not yet known if high dose chemotherapy plus peripheral stem cell transplantation is more     effective than standard therapy for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy     plus peripheral stem cell transplantation with that of standard therapy in treating women who     have locally recurrent or metastatic breast cancer.   "
163202|NCT00002872|"     RATIONALE: Some drugs such as bleomycin or doxycycline, or other compounds like talc, may     help to control fluid in the chest caused by cancer. It is not yet known if bleomycin,     doxycycline, or talc is more effective in treating patients with malignant pleural effusions.      PURPOSE: Randomized phase III trial to compare the effectiveness of bleomycin, doxycycline,     or talc in treating patients with malignant pleural effusions.   "
163203|NCT00002873|"     RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.      PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating women who     have stage I or stage II breast cancer.   "
163220|NCT00002894|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of platinum-based     chemotherapy with or without paclitaxel in treating patients with relapsed ovarian epithelial     cancer.   "
163204|NCT00002874|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can     stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight     prostate cancer by reducing the production of androgens. It is not yet known if radiation     therapy is more effective with or without bicalutamide for prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without bicalutamide in treating patients who have stage II or stage III prostate cancer and     elevated prostate-specific antigen (PSA) levels following radical prostatectomy.   "
163205|NCT00002875|"     RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet     known which chemotherapy regimen is more effective when combined with radiation therapy for     treating medulloblastoma.      PURPOSE: Randomized phase III trial to compare two combination chemotherapy treatments plus     radiation therapy in treating children with newly diagnosed medulloblastoma.   "
164662|NCT00004999|"     The purpose of this study is to look at the effectiveness of giving a new anti-HIV drug     (AG1549) plus Viracept (nelfinavir) plus Combivir (a tablet containing zidovudine plus     lamivudine) to HIV-infected patients who are not taking anti-HIV drugs.   "
163207|NCT00002878|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining PSC     833 with chemotherapy may reduce resistance to the drug, and allow more tumor cells to be     killed. It is not yet known whether combination chemotherapy plus PSC 833 is more effective     than combination chemotherapy alone in treating patients with relapsed or refractory multiple     myeloma.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without PSC 833 in treating patients with relapsed or refractory multiple myeloma.   "
163208|NCT00002879|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effects of cladribine in previously treated or untreated     patients with mantle cell lymphoma.   "
163209|NCT00002880|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients with     relapsed non-Hodgkin's lymphoma.   "
163210|NCT00002881|"     RATIONALE: Hormone therapy may be an effective treatment for prostate cancer.      PURPOSE: Randomized phase III trial to evaluate the effectiveness of treatment with flutamide     and suramin with or without hydrocortisone in men who have metastatic or recurrent prostate     cancer.   "
163211|NCT00002882|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may     stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether     interferon alfa plus combination chemotherapy and interleukin-2 is more effective than     interferon alfa alone in treating patients with melanoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or     without combination chemotherapy plus interleukin-2 in treating patients with melanoma.   "
163212|NCT00002883|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not known whether combining chemotherapy with surgery is more     effective than surgery alone.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without     combination chemotherapy in treating patients with cancer of the esophagus.   "
163213|NCT00002884|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It     is not yet known whether external-beam radiation therapy plus chemotherapy is more effective     with or without internal radiation therapy.      PURPOSE: Randomized phase III trial to compare chemotherapy and external-beam radiation     therapy with or without internal radiation therapy in treating patients with stage I, stage     II, or stage III esophageal cancer.   "
163214|NCT00002887|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug is a way to kill more tumor cells.      PURPOSE: Phase I trial to study the effects of hydroxyurea plus combination chemotherapy in     patients with non-small cell lung cancer.   "
163215|NCT00002888|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether cisplatin plus fluorouracil are more effective than paclitaxel plus     cisplatin in treating patients with advanced head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination     chemotherapy regimens in treating patients with advanced head and neck cancer.   "
163216|NCT00002889|"     RATIONALE: Imaging procedures such as MRI may improve the ability to determine the response     of prostate tumors to therapy.      PURPOSE: Phase II trial to study MRI results in patients with prostate cancer that has been     treated with radiation therapy plus androgen suppression therapy.   "
163217|NCT00002890|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in     treating patients with myelodysplastic syndrome or relapsed or refractory acute myeloid     leukemia or chronic myelogenous leukemia.   "
163218|NCT00002892|"     RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet     known whether interferon alfa following surgery is more effective than surgery alone in     treating patients with melanoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with no     further therapy following surgery in treating patients with stage II, stage III, or recurrent     melanoma.   "
163219|NCT00002893|"     RATIONALE: Palliative chemotherapy may help patients with advanced colorectal cancer live     longer and more comfortably.      PURPOSE: Randomized phase III trial to compare the effectiveness of and quality of life     following three different palliative chemotherapy regimens in treating patients with advanced     metastatic or recurrent colorectal cancer.   "
168632|NCT00035750|"     To determine risk factors for atherogenesis in Type 1 diabetes.   "
163221|NCT00002895|"     RATIONALE: It is not yet known if treatment for recurrent ovarian epithelial, fallopian tube,     or primary peritoneal cancer is more effective if it is begun when blood levels of CA 125     become elevated rather than waiting for other indicators of disease recurrence.      PURPOSE: This randomized phase III trial is studying early chemotherapy based on blood levels     of CA 125 alone to see how well it works compared to chemotherapy based on conventional     clinical indicators in patients with recurrent ovarian epithelial, fallopian tube, or primary     peritoneal cancer.   "
163222|NCT00002896|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug, giving the drugs in different ways,     and combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus     fluorouracil and leucovorin before surgery given with or without fluorouracil and leucovorin     after surgery in patients with locally advanced rectal cancer.   "
163223|NCT00002897|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not known whether chemotherapy before surgery is more     effective than surgery alone in treating cancer of the esophagus.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without     chemotherapy in treating patients with stage II or stage III cancer of the esophagus.   "
163224|NCT00002898|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug with surgery and/or     radiation therapy may kill more tumor cells.      PURPOSE: This randomized phase III trial is studying surgery followed by different regimens     of combination chemotherapy given together with radiation therapy and/or additional surgery     to compare how well they work in treating patients with soft tissue sarcoma.   "
163225|NCT00002899|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Adjuvant     radiation therapy may kill any remaining tumor cells following surgery or radiosurgery for     brain metastases.      PURPOSE: This randomized phase III trial is studying surgery or radiosurgery alone to see how     well it works compared to surgery or radiosurgery and whole-brain radiation therapy in     treating brain metastases in patients with solid tumors.   "
163226|NCT00002900|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: This clinical trial is studying the effect of chemotherapy on heart function in     treating women who have breast cancer with negative axillary lymph nodes and who are     undergoing treatment on the SWOG-8897 clinical trial.   "
163227|NCT00002901|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of docetaxel in treating patients with     advanced solid tumors that have not responded to standard therapy or for which there is no     effective therapy.   "
163228|NCT00002902|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of irinotecan plus ICI D1694 in treating     patients with advanced solid tumors.   "
163229|NCT00002903|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with     recurrent or refractory germ cell cancer.   "
163230|NCT00002904|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults     with advanced solid tumors.   "
163231|NCT00002905|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients with HIV-related non-Hodgkin's lymphoma that has relapsed or has not responded to     chemotherapy.   "
163232|NCT00002907|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with     relapsed multiple myeloma.   "
163233|NCT00002908|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of bryostatin 1 in treating patients who     have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.   "
163234|NCT00002909|"     Phase I trial to study the effectivenes of phenylbutyrate in treating adults with refractory     solid tumor or lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die.   "
163235|NCT00002911|"     RATIONALE: Marimastat may stop the growth of non-small cell lung cancer by stopping blood     flow to the tumor.      PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of     marimastat in treating patients who have residual stage III non-small cell lung cancer.   "
163236|NCT00002912|"     Phase I trial to study the effectiveness of PSC-833 plus etoposide and mitoxantrone in     treating children who have refractory or relapsed acute leukemia. Drugs used in chemotherapy     use different ways to stop cancer cells from dividing so they stop growing or die. Some     cancers become resistant to chemotherapy drugs. Combining PSC-833 with chemotherapy may     reduce resistance to the drug and allow more cancer cells to be killed.   "
163237|NCT00002913|"     Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or     without filgrastim in treating patients who have newly diagnosed stage III or stage IV     epithelial ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may     increase the number of immune cells found in bone marrow or peripheral blood and may help a     person's immune system recover from the side effects of chemotherapy   "
163238|NCT00002914|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of piritrexim in treating patients with     advanced cancer of the urinary tract that has not responded to previous treatment.   "
163240|NCT00002916|"     RATIONALE: Vaccines made from human papillomavirus may make the body build an immune response     to and kill cervical cancer cells. Combining vaccine therapy with surgery may be a more     effective treatment for cervical cancer.      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with     surgery works in treating patients with early cervical cancer.   "
163241|NCT00002917|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel in treating patients with     early-stage bladder cancer.   "
163242|NCT00002919|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following     surgery in treating patients with stage II bladder cancer.   "
163243|NCT00002920|"     RATIONALE: It is not yet known whether medroxyprogesterone is effective in preventing     endometrial disorder in patients with breast cancer who are taking tamoxifen.      PURPOSE: Randomized phase III trial to study the effectiveness of medroxyprogesterone in     preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ,     lobular carcinoma in situ, Paget's disease of the nipple, stage I breast cancer, or stage II     breast cancer and who are taking tamoxifen.   "
163247|NCT00002924|"     RATIONALE: Gene mutations may make prostate cancer cells unable to attach to androgens. This     may permit the growth of prostate cancer. Gene testing may improve the identification of     patients with advanced prostate cancer.      PURPOSE: Clinical trial to study the androgen receptor gene in patients with prostate cancer     that is not responsive to hormone therapy.   "
163248|NCT00002925|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Some cancers may become resistant to chemotherapy drugs.     Combining PSC 833 with chemotherapy may reduce resistance to the drugs and allow the cancer     cells to be killed. Interleukin-2 may stimulate a person's white blood cells to kill leukemia     cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus PSC 833     followed by additional chemotherapy or peripheral stem cell transplantation and interleukin-2     in treating patients with untreated acute myelogenous leukemia.   "
163249|NCT00002926|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of peripheral stem cell     transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome     or acute myelogenous leukemia.   "
163250|NCT00002928|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with     recurrent or progressive advanced epithelial ovarian cancer following previous paclitaxel.   "
163251|NCT00002930|"     RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 positron emission tomography     (PET) scans, may improve the ability to detect lung and esophageal cancer or their     recurrence.      PURPOSE: Phase II/III trial to study the effectiveness of fludeoxyglucose F 18 PET scans in     measuring response to induction chemotherapy in patients with esophageal and lung cancer that     may be removed by surgery.   "
163252|NCT00002931|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with bone marrow transplantation or peripheral stem cell transplantation works in treating     patients with relapsed germ cell cancer.   "
163253|NCT00002932|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of cisplatin and radiation therapy in     treating patients with stage IV cancer of the head and neck.   "
163254|NCT00002933|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who     have metastatic or recurrent colorectal cancer.   "
163255|NCT00002934|"     RATIONALE: The evaluation of breast cancer recurrence rates may improve the ability to plan     cancer treatment for patients with breast cancer.      PURPOSE: Study to evaluate the rate of recurrence of breast cancer in women who have had     surgery for ductal carcinoma in situ.   "
163256|NCT00002935|"     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to     light to kill tumor cells. This may be an effective treatment for esophageal cancer.      PURPOSE: Phase II trial to study the effectiveness of photodynamic therapy in treating     patients with Barrett's esophagus who have in situ esophageal cancer.   "
163257|NCT00002936|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of altretamine plus etoposide in treating     patients with HIV-related cancer.   "
163262|NCT00002941|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give     higher doses of chemotherapy and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     peripheral stem cell transplantation in treating children who have recurrent or refractory     Hodgkin's lymphoma or non-Hodgkin's lymphoma.   "
163263|NCT00002942|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation     or peripheral stem cell transplantation may allow the doctor to give higher doses of     chemotherapy drugs and kill more tumor cells.      PURPOSE: Randomized phase III trial to compare bone marrow transplantation with peripheral     stem cell transplantation following carboplatin in treating patients with breast cancer.   "
163264|NCT00002943|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation     may help the body kill more tumor cells.      PURPOSE: Phase II trial to study the effects of high doses of carboplatin, etoposide, and     cyclophosphamide followed by autologous bone marrow transplantation in patients with relapsed     or refractory germ cell cancer and other chemotherapy-sensitive solid tumors.   "
163265|NCT00002944|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: This randomized phase III trial is studying two different combination chemotherapy     regimens and comparing how well they work in treating children with low-grade astrocytomas or     other residual tumors of the brain.   "
163266|NCT00002945|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.     Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.      PURPOSE: Phase III trial to study the effectiveness of high-dose combination chemotherapy,     peripheral stem cell transplantation, and interleukin-2 in treating patients who have acute     myeloid leukemia.   "
163269|NCT00002948|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of drugs and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of high-dose topotecan and peripheral stem     cell transplantation in treating patients with refractory cancer.   "
163270|NCT00002442|"     The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules     (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either     indinavir (IDV) or nelfinavir (NFV) for 24 weeks.   "
163271|NCT00002443|"     To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT     administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.   "
163272|NCT00002444|"     To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients     with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ     following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these     patients.      Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing     substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits     antimicrobial activity that may extend to Cryptosporidial infection.   "
163273|NCT00002445|"     The purpose of this study is to see if it is safe and effective to use IM862 to treat     Kaposi's sarcoma (KS) in AIDS patients.   "
163274|NCT00002446|"     The purpose of this study is to compare the safety and effectiveness of 2 treatments for     thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is     a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared     to fluconazole.   "
163275|NCT00002447|"     The purpose of this study is to compare 2 anti-HIV drug combinations.   "
163276|NCT00002448|"     The purpose of this study is to examine how the immune systems of HIV-infected patients react     to 2 anti-HIV drug combinations.   "
163277|NCT00002449|"     The purpose of this study is to see if it is safe and effective to give HIV-positive patients     L2-7001 (a type of interleukin-2) plus anti-HIV therapy. Interleukin-2 (IL-2) is a substance     naturally produced by the body's white blood cells that plays an important role in helping     the body fight infection. IL-2 may be able to boost the immune systems of people with HIV     infection.   "
163278|NCT00002450|"     The purpose of this study is to see if giving tenofovir DF plus a combination of other     anti-HIV drugs is safe and effective.   "
163279|NCT00002949|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining radiation therapy with chemotherapy with may kill more     tumor cells.      PURPOSE: Phase I trial to study the effectiveness of chemotherapy with vinorelbine and     paclitaxel plus radiation therapy in treating patients with advanced cancer arising in the     pelvis.   "
163280|NCT00002950|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as sargramostim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase I/II trial to study the effectiveness of topotecan plus sargramostim in     treating patients who have advanced cancer.   "
164718|NCT00005293|"     To identify risk factors for bronchopulmonary dysplasia/chronic pulmonary disease of     prematurity and to estimate proportions of this group of disorders attributable to antenatal     risk factors, perinatal events, and neonatal care procedures.   "
163281|NCT00002951|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in     treating patients with head and neck cancer.   "
163282|NCT00002952|"     RATIONALE: Vaccines made from a tumor antigen gene may make the body build an immune response     to kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor     and by stimulating a person's white blood cell to kill melanoma cells. Combining vaccine     therapy with interleukin-12 may kill more melanoma cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy plus interleukin-12     in treating patients who have metastatic melanoma.   "
163283|NCT00002953|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and     cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast     cancer.   "
163284|NCT00002955|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients with advanced cancer of the pancreas.   "
163285|NCT00002956|"     RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help     the body kill cancers associated with this virus.      PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells     derived from matched donors in organ transplant patients with lymphoproliferative diseases     associated with Epstein-Barr virus.   "
163286|NCT00002960|"     RATIONALE: Giving the p53 gene for ovarian, fallopian tube, or peritoneal cancer may inhibit     tumor growth. Giving the gene directly into the peritoneum may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of SCH-58500 in treating patients who have     recurrent or persistent primary ovarian, fallopian tube, or peritoneal cancer.   "
163287|NCT00002961|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.     Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy,     radiation therapy, and bone marrow transplantation may kill more cancer cells.      PURPOSE: Randomized phase III trial to compare high-dose chemotherapy with or without     total-body irradiation before bone marrow transplantation in treating children with acute     lymphoblastic leukemia.   "
163288|NCT00002963|"     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to     light to kill tumor cells. Photodynamic therapy using aminolevulinic acid cream may be     effective in treating patients with skin cancer.      PURPOSE: This randomized phase II trial is studying how well photodynamic therapy works in     treating patients with skin cancer.   "
163289|NCT00002964|"     RATIONALE: Drugs that make cancer cells more visible to light may help in the diagnosis of     head and neck cancer.      PURPOSE: Phase II trial to study the usefulness of porfimer sodium in diagnosing patients     with head and neck cancer.   "
163290|NCT00002965|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells.      PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating patients     with recurrent unresectable meningiomas and malignant meningiomas.   "
163291|NCT00002967|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor     cells.      PURPOSE: Randomized phase III trial to study the effectiveness of tamoxifen, octreotide, and     chemotherapy in treating women who have stage I or stage II breast cancer.   "
163292|NCT00002968|"     Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal     antibody therapy in treating patients who have stage II colon cancer. Monoclonal antibodies     such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing     substances to them without harming normal cells. It is not yet known whether surgery to     remove colon cancer is more effect with or without monoclonal antibody therapy.   "
163293|NCT00002969|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy with paclitaxel in     treating patients with stage IIIB or stage IV non-small cell lung cancer.   "
163294|NCT00002970|"     Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or     refractory hematologic cancer. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die.   "
163295|NCT00002971|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of O(6)-benzylguanine given before surgery     to patients who have malignant glioma.   "
163296|NCT00002972|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who     have unresectable stage IIIB, stage IV or recurrent lung cancer.   "
163297|NCT00002973|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several     degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of melphalan and whole-body hyperthermia     in treating patients with advanced melanoma.   "
163298|NCT00002974|"     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above     body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. Combining chemotherapy with whole-body hyperthermia may     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of whole-body hyperthermia plus     combination chemotherapy in treating patients who have advanced sarcoma that is metastatic or     that cannot be surgically removed.   "
163299|NCT00002975|"     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to     light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in     treating patients with skin cancer.      PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that     includes aminolevulinic acid works in treating patients with skin cancer.   "
163300|NCT00002976|"     RATIONALE: Estrogen replacement therapy may improve quality-of-life in postmenopausal women     with endometrial cancer. It is not yet known whether estrogen replacement therapy will affect     cancer recurrence.      PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of estrogen     replacement therapy in treating women who have stage I or stage II endometrial cancer.   "
163301|NCT00002977|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of melphalan and thiotepa followed by     peripheral stem cell transplantation in treating patients with stage III or stage IV     epithelial ovarian cancer in complete remission.   "
163302|NCT00002980|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients with     stage III or stage IV melanoma or other advanced cancer that has not responded to previous     therapy.   "
163303|NCT00002981|"     RATIONALE: New imaging procedures, such as PET scan, may improve the ability to detect new or     recurrent prostate cancer.   "
163304|NCT00002982|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give     higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with peripheral stem cell transplantation works in treating older patients with refractory or     relapsed intermediate-grade non-Hodgkin's lymphoma.   "
163305|NCT00003397|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.     Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing     substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation     plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.   "
164742|NCT00005318|"     To investigate the epidemiology of adult respiratory distress syndrome (ARDS) and the     evolution of the inflammatory process in patients with acute lung injury.   "
163306|NCT00003398|"     RATIONALE: Bone marrow that has been treated to remove certain white blood cells may be able     to replace immune cells that were destroyed by chemotherapy or radiation therapy, and may     reduce the chance of developing graft-versus-host disease following bone marrow     transplantation.      PURPOSE: Phase IV trial to study the incidence of graft-versus-host disease in patients who     have hematologic cancer and who are undergoing bone marrow transplantation from a donor.   "
163307|NCT00003399|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation     plus combination chemotherapy in treating patients who have multiple myeloma.   "
163308|NCT00003400|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug with peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of high dose chemotherapy plus peripheral     stem cell transplantation followed by combination chemotherapy in treating patients with     metastatic prostate cancer that has not responded to hormone therapy.   "
163309|NCT00003401|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation     plus combination chemotherapy in treating patients who have multiple myeloma that has been     treated for longer than 12 months.   "
163310|NCT00003402|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation     plus combination chemotherapy in treating patients who have low-grade non-Hodgkin's lymphoma     or chronic lymphocytic leukemia.   "
163311|NCT00003403|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of GPX-100 in treating patients who have     solid tumors.   "
163312|NCT00003404|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy     following surgery may be effective in treating patients with phyllodes tumor of the breast.      PURPOSE: This phase II trial is studying how well radiation therapy works after surgery in     treating women with phyllodes tumor of the breast.   "
163313|NCT00003405|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Biological therapies use different ways to stimulate the immune     system and stop cancer cell from growing. Combining more than one chemotherapy drug with     biological therapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, isotretinoin,     and interferon alfa in treating patients who have acute myelogenous leukemia.   "
163329|NCT00003421|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which chemotherapy regimen is more effective for advanced Hodgkin's disease.      PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in     treating patients with advanced Hodgkin's disease.   "
163314|NCT00003406|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel, ifosfamide, and     carboplatin followed by peripheral stem cell transplantation in treating patients with     refractory cancer.   "
163315|NCT00003407|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal     cells from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of amifostine and high-dose combination     chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous     leukemia.   "
163316|NCT00003408|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Combining chemotherapy and peripheral stem cell transplantation     with biological therapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of biological therapy with sargramostim,     interleukin-2, and interferon alfa following chemotherapy and peripheral stem cell     transplantation in treating patients who have cancer.   "
163317|NCT00003409|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin     gadolinium may increase the effectiveness of radiation therapy by making tumor cells more     sensitive to radiation.      PURPOSE: Phase I trial to study the effectiveness of motexafin gadolinium plus radiation     therapy in treating patients who have newly diagnosed glioblastoma multiforme.   "
163318|NCT00003410|"     RATIONALE: New imaging procedures such as the use of gadolinium texaphyrin with MRI may     improve the ability to detect the extent of gliomas.      PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin used with     MRI-guided surgery in treating patients with high-grade glioma.   "
163319|NCT00003411|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin     gadolinium may increase the effectiveness of radiation therapy by making tumor cells more     sensitive to treatment.      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus motexafin     gadolinium in treating patients with bile duct, gallbladder, or pancreatic cancer that cannot     be removed surgically.   "
163320|NCT00003412|"     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by     stimulating a person's white blood cells to kill breast cancer cells.      PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating women with     metastatic breast cancer who have received high-dose chemotherapy and peripheral stem cell     transplantation.   "
163321|NCT00003413|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug with peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian     epithelial cancer.   "
163322|NCT00003414|"     RATIONALE: Cyclosporine may induce graft-versus-host disease and make the body build an     immune response that will kill cancer cells. Interleukin-2 and interferon gamma may enhance     the effectiveness of graft-versus-host disease to kill cancer cells.      PURPOSE: Randomized phase III trial to determine the effectiveness of graft-versus-host     disease in treating patients who have recurrent or refractory lymphoma or Hodgkin's disease .   "
163323|NCT00003415|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells     from the side effects of chemotherapy.      PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus topotecan in treating     patients with myelodysplastic syndrome.   "
163324|NCT00003416|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.     Interferon alfa may interfere with the growth of the cancer cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan plus peripheral     stem cell transplantation followed by interferon alfa in treating patients with Waldenstrom's     macroglobulinemia.   "
163325|NCT00003417|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems     that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment     may result in more effective radiation therapy. Drugs used in chemotherapy use different ways     to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy     with chemotherapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy that has been     planned with a computer plus chemotherapy in treating patients who have glioblastoma     multiforme.   "
163326|NCT00003418|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     exemestane or tamoxifen may fight breast cancer by blocking the uptake of estrogen. It is not     yet known whether exemestane is more effective than tamoxifen in treating breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of exemestane with that of     tamoxifen in treating postmenopausal women with primary breast cancer who have already     received 2-3 years of tamoxifen following surgery.   "
163327|NCT00003419|"     RATIONALE: HIV virus is found in the lesions of most patients with Kaposi's sarcoma, and may     have a role in causing Kaposi's sarcoma. Antiviral therapy acts against the HIV virus and may     be an effective treatment for Kaposi's sarcoma.      PURPOSE: This phase II trial is studying how well antiviral therapy works in treating     patients with slowly progressing HIV-related Kaposi's sarcoma.   "
163328|NCT00003420|"     RATIONALE: Imaging procedures such as CT scans help the doctor in detecting cancer or the     recurrence of cancer. Increasing the number of times a CT scan is given may improve the     ability to detect stage I testicular cancer.      PURPOSE: Randomized clinical trial to determine if there is a different result from two     different schedules of CT scans in treating patients with stage I testicular cancer after     undergoing orchiectomy.   "
164719|NCT00005294|"     To determine the impact of bronchopulmonary dysplasia (BPD) on childhood development, family     functioning, and parental stress.   "
163330|NCT00003422|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether giving radiation therapy before surgery is more effective     than giving chemotherapy plus radiation therapy after surgery in treating patients with     rectal cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy given before surgery     to see how well it works compared to chemotherapy and radiation therapy given after surgery     in treating patients with rectal cancer that can be surgically removed.   "
163331|NCT00003423|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known which combination chemotherapy regimen is more effective for non-Hodgkin's     lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of     combination chemotherapy in treating children who have newly diagnosed non-Hodgkin's     lymphoma.   "
163332|NCT00003424|"     RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using tamoxifen     may fight liver cancer by blocking the absorption of estrogen. It is not yet known whether     receiving tamoxifen is more effective than no further therapy in treating patients with     primary liver cancer.      PURPOSE: Randomized phase III trial to compare high-dose tamoxifen with no further treatment     in treating patients with liver cancer that cannot be surgically removed.   "
163333|NCT00003425|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.     Chemoprotective drugs such as amifostine may protect normal cells from the side effects of     chemotherapy.      PURPOSE: Phase I/II trial to study the effectiveness of high-dose melphalan plus peripheral     stem cell transplantation and amifostine in treating patients with cancer.   "
163334|NCT00003426|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of gemcitabine plus radiation therapy in     treating patients with pancreatic cancer that can not be surgically removed.   "
163335|NCT00003427|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating     patients with previously treated metastatic gastrointestinal cancer that has not responded to     previous treatment.   "
163336|NCT00003428|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     arzoxifene hydrochloride may fight breast cancer by blocking the use of estrogen by the tumor     cells.      PURPOSE: This randomized phase II trial is comparing two different doses of arzoxifene     hydrochloride to see how well it works in treating women with advanced or metastatic breast     cancer.   "
163337|NCT00003429|"     RATIONALE: New imaging procedures such as fludeoxyglucose F 18 PET scan may improve the     ability to detect cancer or recurrence of cancer.      PURPOSE: Clinical trial to study the effectiveness of fludeoxyglucose F 18 PET scan in     diagnosing primary or recurrent cervical cancer in patients who are undergoing surgery.   "
163338|NCT00003430|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of L-778,123 in treating patients with     recurrent or refractory solid tumors.   "
163339|NCT00003431|"     RATIONALE: Flt3L may stimulate a person's immune system and help kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of flt3L given to patients before     undergoing surgery to remove metastases from colorectal cancer.   "
163340|NCT00003432|"     RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build     an immune response to and kill their tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white     blood cells in treating patients with metastatic breast cancer who have achieved a partial or     complete response after chemotherapy and peripheral stem cell transplantation.   "
163341|NCT00003433|"     RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build     an immune response to kill their tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white     blood cells in treating patients with resected liver metastases from colon cancer.   "
163342|NCT00003434|"     Rational: White blood cells that have been treated with carcinoembryonic antigen peptide-1     may help the body build an immune response to and kill tumor cells that express CEA.      Purpose: Phase II trial to study the effectiveness of white blood cells plus carcinoembryonic     antigen peptide-1 in treating patients with stage I, stage II, or stage III pancreatic cancer     that has been surgically removed.   "
163343|NCT00003435|"     RATIONALE: Antiviral agents are drugs that act against viruses and may be an effective     treatment for HIV. Peripheral stem cell transplantation or umbilical cord blood     transplantation may be able to replace immune cells that were destroyed by chemotherapy and     radiation therapy used to kill tumor cells. Combining either umbilical cord blood     transplantation or peripheral stem cell transplantation with antiviral therapy may be an     effective treatment for HIV-positive patients who have hematologic cancer.      PURPOSE: Phase I trial to study the effectiveness of antiviral therapy plus either peripheral     stem cell transplantation or umbilical cord blood transplantation in treating HIV-positive     patients who have refractory or recurrent hematologic cancer.   "
163344|NCT00003436|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may     allow doctors to give higher doses of chemotherapy and kill more cancer cells. It is not yet     known whether chemotherapy is more effective with or without bone marrow transplantation for     acute myeloid leukemia.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or     without bone marrow transplantation in treating children who have acute myeloid leukemia.   "
164720|NCT00005295|"     To determine risk factors for idiopathic pulmonary fibrosis.   "
163345|NCT00003437|"     RATIONALE: Hormone therapy may stop the growth of cancer cells. Drugs used in chemotherapy     use different ways to stop cancer cells from dividing so they stop growing or die. Combining     hormone therapy with chemotherapy may kill more cancer cells. It is not yet known which     hormone therapy and chemotherapy regimen is most effective for acute lymphoblastic leukemia.      PURPOSE: Randomized phase III trial to compare the effectiveness of different steroid therapy     and chemotherapy regimens in treating children who have acute lymphoblastic leukemia.   "
163346|NCT00003439|"     Phase I trial to study the effectiveness of interleukin-12 in treating patients with     refractory ovarian or abdominal cancers. Interleukin-12 may kill tumor cells by stopping     blood flow to the tumor and by stimulating a persons's white blood cells to kill cancer     cells.   "
163347|NCT00003440|"     This randomized phase III studies how well two different regimens of paclitaxel with or     without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that     is inoperable, recurrent, or metastatic. Drugs used in chemotherapy, such as paclitaxel, use     different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal     antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. It is not yet known what     regimen of paclitaxel is more effective with or without trastuzumab in treating patients with     breast cancer.   "
163348|NCT00003441|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with     metastatic colorectal cancer.   "
163349|NCT00003443|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with     metastatic or recurrent head and neck cancer.   "
163350|NCT00003444|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon     alfa-2b may interfere with the growth of cancer cells. It is not yet known whether giving     radiation therapy with interferon alfa-2b is more effective than giving interferon alfa-2b     alone in treating melanoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus     interferon alfa-2b with that of interferon alfa-2b alone in treating patients who have     melanoma that has metastasized to lymph nodes in the neck, under the arm, or in the groin.   "
163351|NCT00003445|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with     advanced cancer of the cervix.   "
179203|NCT00191360|"     To evaluate long-term safety of growth hormone replacement in adult patients with growth     hormone deficiency   "
163352|NCT00003446|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of trimetrexate glucuronate, fluorouracil,     and leucovorin in treating patients with recurrent or metastatic colorectal cancer.   "
163353|NCT00003447|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine, gemcitabine,     or both in treating patients who have stage IIIB or stage IV non-small cell lung cancer.   "
163354|NCT00003449|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and     gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.   "
163355|NCT00003450|"     RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability     to fight cancer or make the cancer more sensitive to chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of gene therapy using the p53 gene in     treating patients with advanced recurrent or persistent ovarian cancer or primary peritoneal     cavity cancer.   "
163356|NCT00003451|"     Phase I trial to study the effectiveness of combining interleukin-12 and interferon alfa in     treating patients who have residual, recurrent, or metastatic malignant melanoma or other     advanced cancer that has not responded to standard therapy. Interleukin-12 may stimulate a     person's white blood cells to kill cancer cells. Interferon alfa may interfere with the     growth of the cancer cells. Combining interleukin-12 with interferon alfa may kill more     cancer cells.   "
163357|NCT00003452|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy work in treating     patients with stage IV bladder cancer or newly diagnosed stage IV bladder cancer.   "
163358|NCT00003453|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with stage IV adrenal gland cancer.   "
163359|NCT00003454|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     women who have stage IV breast cancer that has not responded to previous therapy.   "
163360|NCT00003455|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     women with stage IV breast cancer that has not responded to standard therapy.   "
163361|NCT00003456|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have glioblastoma multiforme.   "
163379|NCT00003474|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have glioblastoma multiforme.   "
163362|NCT00003457|"     RATIONALE: Current therapies for adults with persistent or recurrent brain tumors provide     very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy     suggest that it may prove beneficial in the treatment of adults with persistent or recurrent     brain tumors.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on adults with persistent or recurrent brain tumors.   "
163363|NCT00003458|"     RATIONALE: Current therapies for childhood brain tumors provide limited benefit to the     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove     beneficial in the treatment of childhood brain tumors.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on children (> 6 months of age) with brain tumors.   "
163364|NCT00003459|"     RATIONALE: Current therapies for a brain stem glioma provide very limited benefit to the     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove     beneficial in the treatment of brain stem gliomas.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on children (> 6 months of age) and adults with newly-diagnosed or     recurrent brain stem gliomas.   "
163365|NCT00003460|"     RATIONALE: Current therapies for children with primitive neuroectodermal tumors that have not     responded to standard therapy provide very limited benefit to the patient. The anti-cancer     properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of     children with primitive neuroectodermal tumors that have not responded to standard therapy.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on children (> 6 months of age) with primitive neuroectodermal     tumors that has not responded to standard therapy.   "
163366|NCT00003461|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive     tumor-killing substances to them without harming normal cells. This may be effective     treatment for primary or metastatic brain tumors.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy     in treating patients with primary or metastatic brain tumors.   "
163367|NCT00003462|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving drugs into the thin space between the lining of the spinal     cord and brain may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of intrathecal busulfan in treating     patients with recurrent, refractory, or metastatic leptomeningeal tumors.   "
164746|NCT00005322|"     To identify genes involved in the pathogenesis of congenital heart disease, including atrial     septal defects (ASDs), paramembranous ventricular septal defects (VSDs), and atrioventricular     canal defects (AVCDs).   "
163368|NCT00003463|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in     treating patients with recurrent supratentorial high grade gliomas.   "
163369|NCT00003464|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating adults with     newly diagnosed primary malignant glioblastoma multiforme.   "
163370|NCT00003465|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with     anaplastic oligodendroglioma.   "
163371|NCT00003466|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients     with progressive low-grade glioma.   "
163372|NCT00003467|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with     recurrent supratentorial low-grade glioma.   "
163373|NCT00003468|"     RATIONALE: Current therapies for children with low grade astrocytomas that have not responded     to standard therapy provide limited benefit to the patient. The anti-cancer properties of     Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with     low grade astrocytomas that have not responded to standard therapy      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on children (> 6 months of age) with low grade astrocytomas that     has not responded to standard therapy.   "
163374|NCT00003469|"     RATIONALE: Current therapies for childhood Rhabdoid tumors provide limited benefit to the     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove     beneficial in the treatment of childhood Rhabdoid tumors.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on children (> 6 months of age) with Rhabdoid tumors.   "
163375|NCT00003470|"     RATIONALE: Current therapies for adults with anaplastic astrocytomas that have not responded     to standard therapy provide very limited benefit to the patient. The anti-cancer properties     of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults     with anaplastic astrocytomas that have not responded to standard therapy.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on adults with anaplastic astrocytomas that have not responded to     standard therapy.   "
163376|NCT00003471|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have low-grade astrocytoma.   "
163377|NCT00003472|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with recurrent or refractory oligodendroglioma after previous chemotherapy,     radiation therapy, and/or biological therapy.   "
163378|NCT00003473|"     RATIONALE: Current therapies for adults with recurrent or refractory mixed gliomas provide     very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy     suggest that it may prove beneficial in the treatment of adults with recurrent or refractory     mixed gliomas.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on adults with recurrent or refractory mixed gliomas.   "
163380|NCT00003475|"     RATIONALE: Current therapies for adults with primary malignant brain tumors that have not     responded to standard therapy provide very limited benefit to the patient. The anti-cancer     properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of     adults with primary malignant brain tumors that have not responded to standard therapy.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on adults with primary malignant brain tumors that have not     responded to standard therapy.   "
163381|NCT00003476|"     RATIONALE: Current therapies for children with primary malignant brain tumors provide limited     benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it     may prove beneficial in the treatment of children with primary malignant brain tumors.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on children with primary malignant brain tumors.   "
163382|NCT00003477|"     RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable     to or have not responded to standard therapy, provide limited benefit to the patient. The     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the     treatment of children with visual pathway gliomas, which are not amenable to or have not     responded to standard therapy.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on children with visual pathway gliomas, which are not amenable to     or have not responded to standard therapy.   "
163383|NCT00003478|"     RATIONALE: Monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing     substances such as radioactive iodine to them without harming normal cells.      PURPOSE: This randomized phase I/II trial is studying the side effects, best way to give, and     best dose of radiolabeled monoclonal antibody and to see how well it works in treating     patients with primary brain tumors.   "
163384|NCT00003479|"     RATIONALE: Current therapies for patients with ependymoma provide limited benefit to the     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove     beneficial in the treatment of patients with ependymoma .      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on patients with ependymoma.   "
163405|NCT00003508|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with advanced mesothelioma.   "
163385|NCT00003483|"     RATIONALE: Current therapies for adults with meningioma provide limited benefit to the     patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove     beneficial in the treatment of adults with meningioma.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on adults with meningioma.   "
163386|NCT00003484|"     RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances,     such as radioactive iodine, to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after     radiation therapy in treating patients with newly diagnosed primary brain tumors that can be     surgically resected.   "
163387|NCT00003485|"     RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have metastatic or unresectable colon cancer.   "
163388|NCT00003486|"     RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with colon cancer.   "
163389|NCT00003487|"     RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with cancer of the esophagus.   "
163390|NCT00003489|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have advanced head and neck cancer.   "
163391|NCT00003490|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. GM-CSF may make cancer cells more sensitive to the effects of     chemotherapy. Combining more than one drug with GM-CSF may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of     cyclophosphamide plus vincristine, following GM-CSF in treating patients with multiple     myeloma that has not responded to previous treatment.   "
163392|NCT00003491|"     Current therapies for Stage IV lung cancer provide very limited benefit to the patient. The     anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the     treatment of Stage IV lung cancer      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on patients with Stage IV lung cancer.   "
163393|NCT00003492|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with stage IV lung cancer.   "
163394|NCT00003493|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of     liposomal doxorubicin, vincristine, and dexamethasone in treating patients with newly     diagnosed or previously treated multiple myeloma.   "
163395|NCT00003494|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have recurrent or stage IV lung cancer.   "
163396|NCT00003495|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have recurrent or stage IV lung cancer.   "
163397|NCT00003496|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have recurrent or extensive-stage small cell lung cancer.   "
163398|NCT00003497|"     RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston capsules in treating     patients who have stage IV non-small cell lung cancer.   "
163399|NCT00003498|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with non-Hodgkin's lymphoma that has not responded to high-dose chemotherapy and     bone marrow transplantation.   "
163400|NCT00003499|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with low-grade non-Hodgkin's lymphoma.   "
163401|NCT00003500|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have refractory or recurrent intermediate-grade stage II, stage III, or stage IV     non-Hodgkin's lymphoma.   "
163402|NCT00003501|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have recurrent or refractory high-grade stage II, stage III, or stage IV     non-Hodgkin's lymphoma after receiving chemotherapy.   "
163403|NCT00003502|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with stage II, stage III, or stage IV mantle cell lymphoma.   "
163406|NCT00003509|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with progressive or recurrent stage IV melanoma.   "
163407|NCT00003511|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with recurrent or progressive multiple myeloma after treatment.   "
163408|NCT00003512|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have recurrent or refractory Waldenstrom's macroglobulinemia.   "
163409|NCT00003513|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have metastatic, recurrent, or refractory neuroblastoma.   "
163410|NCT00003514|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with neuroendocrine tumor that is metastatic or unlikely to respond to surgery or     radiation therapy.   "
163411|NCT00003515|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have metastatic, recurrent, or refractory primitive neuroectodermal tumors.   "
163412|NCT00003516|"     RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have stage III or stage IV prostate cancer.   "
163413|NCT00003517|"     RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with stage III or stage IV prostate cancer.   "
163414|NCT00003518|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus gemcitabine in treating     patients with refractory metastatic germ cell tumors that have not responded to surgery or     chemotherapy.   "
163415|NCT00003519|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is more effective for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination     chemotherapy regimens in treating women with breast cancer who have undergone surgery to     remove the tumor.   "
163417|NCT00003521|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have soft tissue sarcoma.   "
163418|NCT00003522|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have cancer of the small intestine.   "
163419|NCT00003523|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients     with recurrent or refractory ovarian epithelial cancer or primary cancer of the peritoneum.   "
163420|NCT00003524|"     RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have stomach cancer.   "
163421|NCT00003525|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have stage IV cancer of the cervix and/or vulva.   "
163422|NCT00003526|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with cancer of unknown primary origin.   "
163423|NCT00003528|"     Phase I trial to study the effectiveness of raltitrexed in treating children with refractory     acute leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die   "
163424|NCT00003530|"     RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have primary liver cancer.   "
163425|NCT00003531|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     patients with stage IV pancreatic cancer.   "
163426|NCT00003532|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have stage III or stage IV ovarian cancer   "
164747|NCT00005323|"     To conduct an epidemiologic study of persistent pulmonary hypertension of the newborn ( PPHN)     infant.   "
163427|NCT00003533|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have metastatic prostate cancer that has not responded to hormone therapy.   "
163428|NCT00003534|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating     patients who have refractory stage IV prostate cancer.   "
163429|NCT00003535|"     RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the     laboratory. Antineoplastons may inhibit the growth of cancer cells.      PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating     children with recurrent or refractory high grade glioma.   "
163430|NCT00003536|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Antineoplastons are naturally occurring substances that may also be     made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. It is not yet     known whether giving antineoplastons with chemotherapy is more effective than chemotherapy     alone in treating women with refractory breast cancer.      PURPOSE: This randomized phase II trial is studying methotrexate alone to see how well it     works campared to methotrexate and antineoplaston therapy in treating postmenopausal women     with advanced refractory breast cancer.   "
163431|NCT00003537|"     RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit     to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may     prove beneficial in the treatment of adults with anaplastic astrocytoma.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on adults with anaplastic astrocytoma.   "
163432|NCT00003538|"     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the     transplanted cells can make an immune response against the body's normal tissues. Stem cells     that have been treated in the laboratory to remove lymphocytes may prevent this from     happening.      PURPOSE: Clinical trial to prevent graft-versus-host disease in patients undergoing bone     marrow transplantation.   "
163433|NCT00003539|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them     or deliver tumor-killing substances to them without harming normal cells. Combining     chemotherapy with monoclonal antibody therapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus monoclonal antibody     therapy in treating women with recurrent or metastatic breast cancer.   "
163434|NCT00003540|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating women with     metastatic breast cancer previously treated with doxorubicin and paclitaxel.   "
163542|NCT00003693|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of dolastatin 10 in treating patients who     have refractory or relapsed acute leukemia, chronic myelogenous leukemia in blast phase, or     myelodysplastic syndrome.   "
163435|NCT00003541|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Combining chemotherapy, radiation therapy, and peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy, radiation     therapy, and peripheral stem cell transplantation in treating patients who have stage III or     stage IV mantle cell lymphoma.   "
163436|NCT00003542|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa in treating patients     with advanced kidney cancer.   "
163437|NCT00003543|"     RATIONALE: Monoclonal antibodies can find and locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than one drug and combining chemotherapy with monoclonal antibody therapy     may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy plus     combination chemotherapy in treating patients with advanced colorectal cancer.   "
163438|NCT00003544|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with     metastatic colorectal cancer.   "
163439|NCT00003545|"     Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or     relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy     use different ways to stop cancer cells from dividing so they stop growing or die.   "
163440|NCT00003546|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus radiation therapy in     treating patients with pancreatic cancer that cannot be removed surgically.   "
163441|NCT00003548|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of aminocamptothecin in treating patients     with advanced cancer of the peritoneal cavity.   "
163442|NCT00003549|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide,     methotrexate, and fluorouracil in treating patients with Merkel cell cancer.   "
180321|NCT00204386|"     The purpose of this study was to determine if Topiramate was safe and effective for use in     civilian subjects with Posttraumatic Stress Disorder.   "
163444|NCT00003552|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may allow doctors to give     higher doses of chemotherapy and kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy plus peripheral stem     cell transplantation in treating patients with metastatic melanoma.   "
163445|NCT00003553|"     RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before     a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It may     also stop the patient's immune system from rejecting the donor's stem cells. The donated stem     cells may replace the patient's immune cells and help destroy any remaining tumor cells     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte     infusion) after the transplant may help increase this effect. Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     cyclosporine with or without mycophenolate mofetil or methotrexate after the transplant may     stop this from happening.      PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in     treating patients with metastatic kidney cancer.   "
163446|NCT00003554|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them.      PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab in     treating patients with multiple myeloma that is newly diagnosed.   "
163447|NCT00003555|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells     from the side effects of chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of paclitaxel plus chemoprotection with     amifostine in treating patients with recurrent or refractory solid tumors.   "
163448|NCT00003556|"     Phase I trial to study the effectiveness of vaccine therapy in treating patients with     melanoma that cannot be treated with surgery. Vaccines may make the body build an immune     response that may kill tumor cells. Combining more than one vaccine may kill more tumor     cells.   "
163449|NCT00003557|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with     metastatic or recurrent liver, bile duct, or gallbladder cancer.   "
163450|NCT00003558|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is more effective for cancer of unknown     primary origin.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of     combination chemotherapy in treating patients with cancer of unknown primary origin.   "
163451|NCT00003560|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in     treating patients who have stage III or stage IV ovarian cancer, fallopian tube cancer, or     primary peritoneal cancer.   "
163452|NCT00003561|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating     factors such as sargramostim may increase the number of immune cells found in bone marrow or     peripheral blood and may help a person's immune system recover from the side effects of     therapy. Combining sargramostim with interferon alfa may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who     are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in     remission.   "
163453|NCT00003562|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in     treating patients who have stage IIIB or stage IV non-small cell lung cancer.   "
163454|NCT00003563|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gadolinium     texaphyrin may increase the effectiveness of radiation therapy by making tumor cells more     sensitive to radiation. It is not yet known whether giving gadolinium texaphyrin with     radiation therapy is more effective than radiation therapy alone in treating brain     metastases.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without gadolinium texaphyrin in treating patients who have brain metastases.   "
163455|NCT00003564|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether giving procarbazine alone or with isotretinoin is more effective for     recurrent primary malignant glioma.      PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or     with isotretinoin in treating patients with recurrent primary malignant gliomas.   "
163456|NCT00003565|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to compare the effectiveness of docetaxel in treating Caucasian and     African American patients who have solid tumors.   "
163457|NCT00003566|"     RATIONALE: Diagnostic procedures such as thoracoscopy may help to measure a patient's     response to previous treatment.      PURPOSE: Diagnostic trial to determine the accuracy of thoracoscopy in patients who have     stage IIIA non-small cell lung cancer.   "
163458|NCT00003567|"     RATIONALE: Gene therapy may improve the body's ability to fight cancer or make the cancer     more sensitive to chemotherapy. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy     together with chemotherapy in treating patients with advanced solid tumors or non-Hodgkin's     lymphoma.   "
163459|NCT00003568|"     RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells.     Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with     interleukin-2 in treating patients with metastatic melanoma.   "
163460|NCT00003569|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs such as dimesna may protect normal cells from     the side effects of chemotherapy.      PURPOSE: This phase I trial is studying the side effects and best dose of dimesna in treating     patients with solid tumors who are receiving cisplatin and paclitaxel.   "
163461|NCT00003571|"     RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors     improve methods of treating patients with colon cancer.      PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon     cancer.   "
163462|NCT00003572|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bone marrow     transplantation may be able to replace immune cells that have been destroyed by radiation     therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune     response against the body's normal tissues. Mycophenolate mofetil and tacrolimus may be an     effective treatment for graft-versus-host disease caused by bone marrow transplantation.      PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, tacrolimus, and     mycophenolate mofetil plus bone marrow transplantation in treating patients with hematologic     cancers.   "
163463|NCT00003573|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy     followed by combination chemotherapy in treating children with newly diagnosed advanced     medulloblastoma.   "
163464|NCT00003574|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation     therapy in different ways may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients     who are undergoing surgical removal of progressive or recurrent malignant brain tumors.   "
163465|NCT00003575|"     Phase II trial to compare the effectiveness of interleukin-12 following chemotherapy in     treating patients who have refractory HIV-associated non-Hodgkin's lymphoma. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by     stimulating a person' white blood cells to kill cancer cells.   "
163466|NCT00003576|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether surgery plus radiation therapy is more effective than     chemotherapy plus radiation therapy for head and neck cancer.      PURPOSE: This randomized phase III trial is studying surgery and radiation therapy to see how     well they work compared to chemotherapy and radiation therapy in treating patients with stage     III or stage IV head and neck cancer that can be removed during surgery.   "
163494|NCT00003607|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known whether radiation therapy to the prostate and pelvis is more effective than radiation     therapy to the prostate alone in treating prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the     prostate with or without radiation to the pelvis in treating patients with stage I, stage II,     or stage III prostate cancer.   "
163467|NCT00003577|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether combination chemotherapy plus epirubicin is more effective than combination     chemotherapy alone for stage I or stage II breast cancer.      PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see     how well it works compared to combination chemotherapy and epirubicin in treating women with     stage I or stage II breast cancer who have undergone surgery to remove the tumor.   "
163468|NCT00003578|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Bone marrow transplantation may allow doctors to give higher     doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether high dose     chemotherapy plus bone marrow transplantation is more effective than high dose chemotherapy     alone for intermediate- or high-grade non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy     with or without bone marrow transplantation in treating patients who have intermediate- or     high-grade non-Hodgkin's lymphoma.   "
163469|NCT00003580|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy     and radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of amifostine in treating side effects of     treatment in patients receiving radiation therapy and cisplatin for advanced head and neck     cancer.   "
163470|NCT00003582|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side     effects of radiation therapy and chemotherapy.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination     chemotherapy and amifostine in treating patients who have stage II, stage III, or stage IV     head and neck cancer that cannot be surgically removed.   "
163471|NCT00003583|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Drugs such as amifostine may protect normal cells from the side     effects of chemotherapy and radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of amifostine to prevent side effects in     patients who are receiving chemotherapy and radiation therapy for limited-stage small cell     lung cancer.   "
163472|NCT00003584|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Prednisone     may help to relieve symptoms in patients with recurrent and/or metastatic kidney cancer.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of     vinorelbine and estramustine with or without prednisone in treating patients who have     recurrent and/or metastatic kidney cancer.   "
163473|NCT00003585|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die. Combining biological therapy with chemotherapy may     kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of biological therapy plus chemotherapy     in treating patients with metastatic or recurrent kidney cancer.   "
163474|NCT00003587|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of two different combination     chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell     lung cancer   "
163475|NCT00003588|"     Phase I trial to study the effectiveness of gene therapy in treating patients with ovarian     cancer that has not responded to previous treatment. Inserting the p53 gene into a person's     cancer cells may improve the body's ability to fight cancer or make the cancer cells more     sensitive to treatment.   "
163476|NCT00003589|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is more effective in treating advanced     non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of three different     combination chemotherapy regimens in treating patients who have advanced non-small cell lung     cancer.   "
163477|NCT00003590|"     RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with     unresectable benign meningioma.   "
163478|NCT00003591|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in     treating patients who have nonmetastatic, unresectable pancreatic cancer.   "
163479|NCT00003592|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether methotrexate or paclitaxel is more     effective in treating patients with advanced head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of methotrexate with that of     paclitaxel in treating patients who have advanced head and neck cancer that cannot be treated     with cisplatin.   "
163480|NCT00003593|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating     children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia,     or myelodysplastic syndrome.   "
163541|NCT00003692|"     RATIONALE: Video-assisted surgery may be an effective treatment and have fewer side effects     than conventional surgery in patients with non-small cell lung cancer.      PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery in treating     patients who have non-small cell lung cancer.   "
163481|NCT00003594|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which regimen of combination chemotherapy is most effective in treating advanced     colorectal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of various combination     chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic     colorectal cancer that cannot be treated with surgery or radiation therapy.   "
163482|NCT00003595|"     Randomized phase III trial to compare the effectiveness of combination chemotherapy with or     without monoclonal antibody therapy in treating patients who have previously untreated     HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop     cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as     rituximab can locate cancer cells and either kill them or deliver cancer-killing substances     to them without harming normal cells. It is not yet known whether combination chemotherapy     plus monoclonal antibody therapy is more effective than combination chemotherapy alone in     treating HIV-associated non-Hodgkin's lymphoma.   "
163483|NCT00003596|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug or combining radiation therapy with     chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and     mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus     radiation therapy for anal cancer.      PURPOSE: This randomized phase III trial is studying fluorouracil and mitomycin plus     radiation therapy to see how well it works compared to fluorouracil and cisplatin plus     radiation therapy in treating patients with stage II or stage III anal cancer.   "
163484|NCT00003597|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as thrombopoietin and G-CSF may     increase the number of immune cells found in bone marrow or peripheral blood and may help a     person's immune system recover from the side effects of chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of colony-stimulating factors in treating     children who have recurrent or refractory solid tumors and who are receiving chemotherapy.   "
163485|NCT00003598|"     RATIONALE: Tretinoin may help cervical neoplasia cells develop into normal cervical cells. It     is not yet known whether tretinoin is more effective than a placebo in preventing cervical     cancer in patients with cervical neoplasia.      PURPOSE: Randomized clinical trial to study the effectiveness of tretinoin in preventing     cervical neoplasia from developing into cervical cancer.   "
163486|NCT00003599|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of isotretinoin may be an effective way to     prevent lung cancer. Vitamin E may prevent the side effects of isotretinoin therapy.      PURPOSE: Randomized clinical trial to study the effectiveness of vitamin E in preventing the     side effects of isotretinoin in former and current smokers who are receiving isotretinoin to     prevent lung cancer.   "
163487|NCT00003600|"     RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients     with cancer who are receiving chemotherapy. It is not yet known whether epoetin alfa is more     effective than a placebo in treating anemia in patients receiving chemotherapy.      PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of epoetin     alfa with a placebo in treating anemia in cancer patients who are receiving chemotherapy.   "
163488|NCT00003601|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of tretinoin and/or fenretinide may be an     effective way to prevent the recurrence or further development of dysplastic nevus syndrome.      PURPOSE: Randomized phase II trial to compare the effectiveness of tretinoin with or without     fenretinide in treating patients with dysplastic nevus syndrome.   "
163489|NCT00003602|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known which combination chemotherapy regimen is more effective in treating older     patients with acute myeloid leukemia.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination     chemotherapy regimens in treating older patients with acute myeloid leukemia in first     remission.   "
163490|NCT00003603|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.     Steroids, such as dexamethasone or prednisolone, may help relieve some of the side effects of     chemotherapy. It is not yet known which regimen of chemotherapy plus steroid therapy is more     effective in treating patients with multiple myeloma.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of     chemotherapy plus steroid therapy in treating patients with multiple myeloma that has     recurred for the first time.   "
163491|NCT00003604|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer     cells.      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with     stage III or stage IV kidney cancer that has been removed by surgery.   "
163492|NCT00003605|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy     use different ways to stop cancer cells from dividing so they stop growing or die. Combining     chemotherapy and monoclonal antibody therapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab plus cyclophosphamide in     treating patients who have indolent stage III or stage IV non-Hodgkin's lymphoma.   "
163493|NCT00003606|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether combination chemotherapy with or without epirubicin and cyclophosphamide is     more effective in treating patients with extensive stage small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without epirubicin and cyclophosphamide in treating patients who have extensive stage     small cell lung cancer.   "
164142|NCT00004265|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who     have recurrent or refractory non-small cell lung cancer.   "
163495|NCT00002714|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation     therapy in treating patients who have early stage Hodgkin's disease.   "
163496|NCT00002715|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have advanced Hodgkin's lymphoma.   "
163497|NCT00002716|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more cancer cells. It is not     yet known which chemotherapy regimen is more effective for metastatic colorectal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of intrahepatic floxuridine,     leucovorin, and dexamethasone with that of systemic fluorouracil and leucovorin in treating     patients who have unresectable liver metastases from colorectal cancer.   "
163498|NCT00003610|"     RATIONALE: Capsaicin lozenges may be effective treatment for mucositis caused by radiation     therapy. It is not yet known whether capsaicin lozenges are more effective than no treatment     for mucositis caused by radiation therapy.      PURPOSE: Randomized phase III trial to study the effectiveness of capsaicin lozenges in     treating patients with mucositis caused by radiation therapy.   "
163499|NCT00003611|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of acitretin may be an effective way to prevent     the recurrence or further development of skin cancer.      PURPOSE: Randomized clinical trial to study the effectiveness of acitretin in preventing skin     cancers in patients with at least two previously treated skin cancers who have undergone     organ transplantation.   "
163500|NCT00003612|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Monoclonal     antibodies such as trastuzumab can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, carboplatin, and     trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2.   "
163501|NCT00003613|"     This phase I trial is studying the side effects and best dose of carmustine given together     with O(6)-benzylguanine in treating patients with stage I or stage II cutaneous T-cell     lymphoma that has not responded to previous treatment. Drugs used in chemotherapy use     different ways to stop cancer cells from dividing so they stop growing or die. Combining more     than one drug may kill more cancer cells   "
163502|NCT00003614|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus estramustine in     treating patients who have metastatic prostate cancer that has not responded to hormone     therapy.   "
163503|NCT00003615|"     RATIONALE: Immunotoxins such as denileukin diftitox can locate cancer cells and kill them     without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.      PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating     patients who have non-Hodgkin's lymphoma that has not responded to previous treatment.   "
163504|NCT00003616|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of irinotecan in treating patients who     have progressive or recurrent malignant glioma.   "
163505|NCT00003617|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. It is not yet known whether chlorambucil is more effective than     observation in treating low-grade lymphoma of the stomach.      PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of     no further therapy following anti-Helicobacter therapy in treating patients with low-grade     lymphoma of the stomach.   "
163506|NCT00003619|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to     give higher doses of chemotherapy drugs and kill more cancer cells. Isotretinoin may help     cancer cells develop into normal white blood cells.      PURPOSE: Phase I/II trial of topotecan, fludarabine, cytarabine, and filgrastim followed by     peripheral stem cell transplantation or isotretinoin in treating patients who have acute     myeloid leukemia, myelodysplastic syndrome, or recurrent or refractory acute lymphocytic     leukemia.   "
163507|NCT00003620|"     Phase II trial to study the effectiveness of flavopiridol in treating patients who have     chronic lymphocytic leukemia that has not responded to treatment with fludarabine. Drugs used     in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die   "
163508|NCT00003621|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation     therapy in treating patients who have newly diagnosed anaplastic astrocytoma.   "
163509|NCT00003622|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of vinorelbine plus paclitaxel in treating     patients with metastatic prostate cancer that is refractory to hormone therapy.   "
163510|NCT00003623|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of high-dose multivitamins may be an effective     way to prevent the recurrence of early stage bladder cancer. It is not yet known whether     high-dose vitamins are more effective than no further therapy in decreasing the risk of     early-stage bladder cancer.      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of high-dose     multivitamins with a placebo in preventing the recurrence of cancer in patients with early     stage bladder cancer.   "
163511|NCT00003624|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells     from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of amifostine in reducing the risk of side     effects caused by cisplatin and paclitaxel in treating women who have ovarian, peritoneal,     cervical, fallopian tube, uterine, or endometrial cancer.   "
163512|NCT00003625|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation     therapy in treating patients with newly diagnosed brain stem glioma.   "
163513|NCT00003626|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with     metastatic prostate cancer that has not responded to previous hormone therapy.   "
163514|NCT00003627|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining chemotherapy with radiation therapy may kill more tumor cells and allow     doctors to preserve the part of the body where the cancer started. It is not yet known     whether radiation therapy with combination chemotherapy is more effective than radiation     therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically     removed.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus     cisplatin and fluorouracil with radiation therapy alone in treating patients who have     advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed.   "
163515|NCT00003630|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients     who have advanced solid tumors.   "
163516|NCT00003631|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells. Peripheral stem cell     transplantation may be able to replace immune cells that were destroyed by chemotherapy and     radiation therapy used to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in     treating patients with refractory or relapsed Hodgkin's lymphoma.   "
163718|NCT00002988|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of irinotecan plus carmustine in treating     patients who have recurrent primary malignant glioma.   "
163517|NCT00003632|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     peripheral stem cell transplantation in treating patients with newly diagnosed CNS lymphoma.   "
163518|NCT00003633|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of combination     chemotherapy in treating patients with advanced prostate cancer.   "
163519|NCT00003634|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. It is not yet known whether     giving monoclonal antibody therapy is more effective than a placebo in treating patients with     ovarian epithelial, fallopian tube, or peritoneal cancer who have responded to surgery and     chemotherapy.      PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy     in treating patients with residual disease from stage III or stage IV ovarian epithelial,     fallopian tube, or peritoneal cancer following surgery and chemotherapy.   "
163520|NCT00003635|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients with     chronic lymphocytic leukemia that has not responded to fludarabine or alkylating agents.   "
163521|NCT00003636|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It     is not yet known whether chemotherapy before surgery is more effective than chemotherapy     after surgery in treating ovarian, peritoneal, or fallopian tube cancer.      PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to see     how well it works compared to chemotherapy given after surgery with or without additional     surgery in treating patients with stage III or stage IV ovarian cancer, peritoneal cancer, or     fallopian tube cancer.   "
163522|NCT00003637|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether radiation therapy alone is more effective than radiation     therapy plus chemotherapy in treating cancer of the nasopharynx.      PURPOSE: This randomized phase III trial is studying how well radiation therapy and     chemotherapy works compared to radiation therapy alone in treating patients with previously     untreated cancer of the nasopharynx.   "
163523|NCT00003638|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Vaccines may make the body build an immune response to kill tumor     cells. It is not yet known whether THERATOPE vaccine therapy is more effective than standard     vaccine therapy in treating metastatic breast cancer.      PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of THERATOPE     vaccine therapy with that of standard vaccine therapy in treating women who have metastatic     breast cancer.   "
163524|NCT00003673|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating older patients who     have acute myeloid leukemia that has recurred for the first time following at least 3 months     of complete remission.   "
164721|NCT00005296|"     To identify the prevalence of sleep apnea in men and its relationship to age, assess the     natural history of the disorder, and predict those men at risk.   "
163525|NCT00003674|"     RATIONALE: Dalteparin may be effective in inhibiting the growth of blood vessels in tumors,     decreasing the risk of metastatic cancer, preventing the formation of blood clots, and     improving quality of life in treating patients with advanced cancer that has not responded to     previous treatment. It is not yet known if standard therapy is more effective with or without     dalteparin in treating advanced breast, lung, colorectal, and prostate cancer.      PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of standard     therapy with or without dalteparin in treating patients who have advanced breast, lung,     colorectal, or prostate cancer that has not responded to previous chemotherapy or hormone     therapy.   "
163526|NCT00003675|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Randomized phase II trial to study the effectiveness of topotecan in treating     patients who have myelodysplastic syndrome.   "
163527|NCT00003677|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients who     have metastatic pancreatic cancer.   "
163528|NCT00003678|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of at least 2 years of     tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast     cancer that has been surgically removed.   "
163529|NCT00003679|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether doxorubicin plus docetaxel is more effective than doxorubicin plus     cyclophosphamide for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of doxorubicin in     combination with either docetaxel or cyclophosphamide in treating women who have previously     untreated, advanced, or inflammatory breast cancer.   "
163530|NCT00003680|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It     is not yet known whether high-dose chemotherapy plus peripheral stem cell transplantation is     more effective than standard chemotherapy for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of standard chemotherapy     with that of high-dose chemotherapy plus peripheral stem cell transplantation in treating     women who have advanced breast cancer or inflammatory breast cancer.   "
163531|NCT00003681|"     RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome.     Epoetin alfa may stimulate red blood cell production and be an effective treatment for anemia     in patients with myelodysplastic syndrome.      PURPOSE: Phase II trial to study the effectiveness of amifostine with or without epoetin alfa     in treating patients who have myelodysplastic syndrome.   "
163532|NCT00003682|"     RATIONALE: Drugs used in chemotherapy use different ways to make cancer cells stop dividing     so they stop growing or die. Combining chemotherapy with corticosteroids may be an effective     treatment for prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with     or without doxorubicin in treating patients who have metastatic prostate cancer that has not     responded to hormone therapy.   "
163533|NCT00003683|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and ifosfamide in     treating patients who have metastatic kidney cancer.   "
163534|NCT00003684|"     RATIONALE: Theophylline may help to relieve shortness of breath in patients who have cancer.     It is not yet known whether theophylline is more effective than no further treatment for     shortness of breath.      PURPOSE: Randomized phase III trial to determine the effectiveness of theophylline in     treating shortness of breath in patients who have cancer.   "
163535|NCT00003685|"     RATIONALE: Radiation therapy may relieve symptoms in patients with non-small cell lung     cancer. It is not yet known which regimen of radiation therapy is most effective in relieving     symptoms in patients with non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of     radiation therapy to relieve symptoms in patients who have non-small cell lung cancer.   "
163536|NCT00003686|"     RATIONALE: Pilocarpine may help to relieve dry mouth in patients receiving opioids for cancer     therapy. It is not yet known whether pilocarpine is more effective than no further treatment     for this condition.      PURPOSE: Randomized phase III trial to determine the effectiveness of pilocarpine in treating     patients who have dry mouth caused by opioids.   "
163537|NCT00003687|"     RATIONALE: Different drug formulations and combinations of drugs may help patients with     chronic pain live more comfortably. It is not yet known which regimen is most effective for     chronic pain.      PURPOSE: Randomized phase III trial to compare the effectiveness of different morphine     formulations with or without dextromethorphan in treating chronic pain in patients who have     advanced cancer.   "
163538|NCT00003688|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of dactinomycin in treating patients who     have persistent or recurrent gestational trophoblastic neoplasia.   "
163539|NCT00003690|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of flavopiridol plus cisplatin or     carboplatin in treating patients who have advanced solid tumors.   "
163540|NCT00003691|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating     patients who have stage III, stage IV, or recurrent endometrial cancer.   "
163543|NCT00003694|"     Phase II trial to study the effectiveness of homoharringtonine plus low-dose cytarabine in     treating patients who have newly diagnosed chronic phase chronic myelogenous leukemia. Drugs     used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Combining more than one drug may kill more cancer cells.   "
163544|NCT00003695|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with surgery may kill more tumor cells. It     is not yet known whether chemotherapy plus surgery is more effective than chemotherapy alone     in treating patients with stage II or stage III ovarian cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or     without surgery in treating patients with stage II or stage III ovarian cancer.   "
163545|NCT00003696|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is most effective for extensive-stage small     cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination     chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.   "
163546|NCT00003697|"     RATIONALE: Dimethylxanthenone acetic acid may stop the growth of cancer cells by stopping     blood flow to the tumor.      PURPOSE: Phase I trial to study the effectiveness of dimethylxanthenone acetic acid in     treating patients with solid tumors that have not responded to previous therapy.   "
163547|NCT00003698|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of combretastatin A4 phosphate in treating     patients who have advanced malignant solid tumors.   "
163548|NCT00003700|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have untreated acute lymphoblastic leukemia.   "
163549|NCT00003701|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether four-drug combination chemotherapy is more effective than two-drug     combination chemotherapy in treating bladder cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination     chemotherapy regimens in treating patients who have bladder cancer.   "
164748|NCT00005324|"     To identify genetic mechanisms controlling apolipoprotein levels and other 'non-traditional'     risk factors in families ascertained through probands with premature coronary artery disease     (CAD).   "
163550|NCT00003702|"     Randomized phase III trial to compare the effectiveness of methotrexate with that of     dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether methotrexate is more effective than dactinomycin in treating     patients with gestational trophoblastic neoplasia.   "
163551|NCT00003703|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of chemotherapy using sarCNU in patients     who have advanced solid tumors.   "
163552|NCT00003704|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs such as     capecitabine may make the tumor cells more sensitive to radiation therapy.      PURPOSE: Phase I trial to study the effectiveness of capecitabine in combination with     radiation therapy in treating patients who have unresectable, residual, or recurrent     colorectal cancer located in the pelvis.   "
163553|NCT00003705|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of BMS-184476 in treating patients who have     advanced solid tumors.   "
163554|NCT00003706|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemotherapy drugs may have different effects in patients with     different degrees of kidney function.      PURPOSE: Phase I trial to study the effectiveness of LY231514 in treating patients who have     locally advanced or metastatic solid tumors and varying degrees of kidney function.   "
163555|NCT00003707|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of combining R115777 with gemcitabine in     treating patients with advanced cancer.   "
163556|NCT00003708|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of temozolomide in treating patients who     have advanced solid tumors.   "
163557|NCT00003709|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of carbendazim in treating patients who     have advanced solid tumors.   "
163558|NCT00003710|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of irinotecan plus mitomycin in treating     patients who have advanced solid tumors that are persistent or recurrent.   "
163559|NCT00003711|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with pemetrexed     disodium and irinotecan in treating patients who have metastatic solid tumors.   "
163560|NCT00003712|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have     advanced solid tumors.   "
163561|NCT00003713|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of intoplicine in treating patients who     have advanced or metastatic solid tumors.   "
163562|NCT00003714|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients     who have unresectable primary or metastatic kidney cancer that has not been previously     treated.   "
163563|NCT00003715|"     RATIONALE: Vaccines made from a person's melanoma cells may make the body build an immune     response to kill tumor cells. Interferon alfa may interfere with the growth of the cancer     cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of melanoma vaccine with     that of interferon alfa-2b in treating patients who have stage III melanoma that has spread     to regional lymph nodes following surgery.   "
163564|NCT00003716|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have     lymphoproliferative disorder that is associated with immunosuppression therapy.   "
163565|NCT00003717|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than once drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus estramustine in     treating patients who have metastatic prostate cancer that has not responded to hormone     therapy.   "
163566|NCT00003718|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who     have advanced soft tissue sarcoma.   "
163567|NCT00003719|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who     have stage IV or recurrent soft tissue sarcoma that has been previously treated with     chemotherapy.   "
163568|NCT00003720|"     RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the     tumor.      PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have     AIDS-related Kaposi's sarcoma.   "
163569|NCT00003721|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of COL-3 in treating patients who have     advanced solid tumors.   "
164749|NCT00005325|"     To seek out genes or genetic markers which identify subjects more vulnerable to hypertension     under the influence of environmental factors.   "
163570|NCT00003723|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating     patients with malignant mesothelioma of the pleura that cannot be removed by surgery.   "
163571|NCT00003724|"     RATIONALE: Video-assisted surgery may have fewer side effects than conventional surgery in     patients with lung metastases. It is not yet known whether conventional surgery or     video-assisted surgery is more effective in treating lung metastases.      PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with     that of video-assisted surgery in treating patients who have lung metastases.   "
163572|NCT00003725|"     RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer and     may have fewer side effects and improve recovery. Drugs used in chemotherapy use different     ways to stop tumor cells from dividing so they stop growing or die. It is not yet known     whether transurethral resection plus AD 32 is more effective than transurethral resection     alone for bladder cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of transurethral resection     surgery followed by AD 32 with that of transurethral resection alone in treating patients who     have newly diagnosed or recurrent bladder cancer.   "
163573|NCT00003726|"     RATIONALE: Anticoagulants, such as lepirudin, may help prevent blood clots from forming in     patients who have received chemotherapy for small cell lung cancer.      PURPOSE: This phase I/II trial is studying the side effects and best dose of lepirudin in     treating patients with recurrent or advanced small cell lung cancer.   "
163574|NCT00003727|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with a peripheral stem cell transplant     and immunotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill     more cancer cells. Biological therapies use different ways to stimulate the immune system and     stop cancer cells from growing.      PURPOSE: This phase II trial is studying giving chemotherapy together with a peripheral stem     cell transplant followed by immunotherapy to see how well it works in treating patients with     chronic phase chronic myelogenous leukemia.   "
163575|NCT00003728|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which regimen of combination chemotherapy plus steroid therapy is more effective     for acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of     combination chemotherapy plus steroid therapy in treating children who have acute     lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.   "
163576|NCT00003729|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     children who have relapsed or refractory acute lymphocytic leukemia.   "
163577|NCT00003730|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized clinical trial to study the effectiveness of vinorelbine plus     fluorouracil in treating women who have metastatic breast cancer that has been previously     treated with at least one regimen of chemotherapy.   "
163578|NCT00003731|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with     recurrent oligodendroglial tumors.   "
164722|NCT00005297|"     To determine the prevalence and longitudinal course of sleep apnea among men and women and to     examine the associations of apnea, oxygen desaturation, snoring, high blood pressure, and     other biomedical correlates.   "
163579|NCT00003732|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin     and paclitaxel in treating patients who have stage II, stage III, or stage IV ovarian cancer.   "
163580|NCT00003733|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of sequential chemotherapy in treating     patients with residual disease following surgery for stage IIB, stage III, or stage IV     ovarian cancer.   "
163581|NCT00003734|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using     triptorelin and flutamide may fight cancer by reducing the production of androgens. It is not     yet known whether giving hormone therapy for 4 months is more effective than giving therapy     for 8 months prior to radiation therapy for prostate cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of combination hormone therapy     for 4 or 8 months followed by radiation therapy in treating patients with prostate cancer.   "
163582|NCT00003735|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of topotecan in treating children who have     relapsed acute leukemia, acute myeloid leukemia, or blast phase chronic myelogenous leukemia.   "
163583|NCT00003736|"     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective     treatment for breast cancer. Diagnostic procedures such as MRI may improve the ability to     detect breast cancer.      PURPOSE: Screening and diagnostic trial to study the effectiveness of MRI scans in women who     are at high risk for developing breast cancer.   "
163584|NCT00003737|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analog in treating     children who have relapsed or refractory neuroblastoma.   "
163602|NCT00003757|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy consisting     of rituximab in treating patients with refractory or recurrent hairy cell leukemia following     cladribine therapy.   "
163585|NCT00003739|"     RATIONALE: Antibiotics may decrease the side effects of neutropenia and fever caused by     chemotherapy. Colony-stimulating factors such as G-CSF may increase the number of immune     cells found in bone marrow or peripheral blood and may help a person's immune system recover     from the side effects of chemotherapy. It is not yet known whether antibiotic therapy plus     G-CSF is more effective than antibiotic therapy alone for treating side effects caused by     chemotherapy.      PURPOSE: Randomized phase III trial to compare the effectiveness of antibiotic therapy with     or without G-CSF in treating children who have neutropenia and fever that are caused by     chemotherapy.   "
163586|NCT00003740|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who     have prostate cancer that has not responded to hormone therapy.   "
163587|NCT00003741|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.   "
163588|NCT00003742|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating     patients with locally advanced or metastatic solid tumors.   "
163589|NCT00003743|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill neuroblastoma     cells.      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating children with     stage IV neuroblastoma who have received induction therapy and peripheral stem cell     transplantation.   "
163590|NCT00003744|"     The purpose of this study is to see how patients with incurable salivary gland cancer, who     have not had chemotherapy before, respond to Gemcitabine. The investigators are trying to     find out what effects (good and bad) Gemcitabine has on participants and salivary gland     cancer.      Gemcitabine has been shown to be an effective chemotherapy agent in other types of cancer,     including; bladder cancer, breast cancer, certain types of lung cancer, ovarian cancer, and     pancreas cancer. Gemcitabine has yet to be studied for efficacy in subjects with salivary     gland cancer and in general other chemotherapy drugs have shown to be ineffective so far in     this population.   "
163591|NCT00003745|"     Phase II trial to study the effectiveness of topotecan in treating children who have     recurrent, relapsed, or refractory sarcoma. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die.   "
163592|NCT00003746|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if giving cladribine once a day is more     effective than giving cladribine once a week in patients with hairy cell leukemia.      PURPOSE: Randomized phase III trial to compare the effectiveness of cladribine given once a     day to cladribine given once a week in treating patients with hairy cell leukemia.   "
163593|NCT00003747|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and temozolomide     in treating patients who have unresectable or metastatic melanoma.   "
163594|NCT00003748|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who     have esophageal or stomach cancer.   "
163595|NCT00003749|"     RATIONALE: Lymphadenectomy may remove cancer cells that have spread to nearby lymph nodes.     Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether     conventional surgery is more effective with or without lymphadenectomy and/or radiation     therapy in treating endometrial cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with     or without lymphadenectomy and/or radiation therapy in treating patients who have endometrial     cancer.   "
163596|NCT00003750|"     RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein use different     ways to stimulate the immune system and stop cancer cells from growing.      PURPOSE: Phase I trial to study the effectiveness of hu14.18-interleukin-2 fusion protein in     treating children who have refractory or recurrent neuroblastoma or other tumors.   "
163597|NCT00003751|"     RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the     tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation     therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be     effective in treating glioblastoma.      PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and     radiation therapy in treating patients who have newly diagnosed glioblastoma.   "
163598|NCT00003752|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase II trial to study the effectiveness of bexarotene in treating     patients who have metastatic breast cancer.   "
163599|NCT00003753|"     RATIONALE: Drugs used in chemotherapy, such as floxuridine, dexamethasone, and irinotecan,     use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic     arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Combining     more than one drug and giving them in different ways may kill any tumor cells remaining after     surgery.      PURPOSE: Phase II trial to study the effectiveness of irinotecan combined with hepatic     arterial infusion with floxuridine and dexamethasone after surgery in treating patients who     have liver metastases from colorectal cancer.   "
163600|NCT00003754|"     RATIONALE: Thalidomide may kill tumor cells by stopping the growth of new blood vessels to     the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining thalidomide with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and     cyclophosphamide in treating children who have recurrent or refractory childhood cancers.   "
164750|NCT00005326|"     To continue studies on the two major neurological complications of sickle cell disease (SCD):     namely, stroke and chronic encephalopathy.   "
163603|NCT00003758|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of     cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.   "
163604|NCT00003759|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Biological therapies such as BCG use different ways to stimulate     the immune system and stop cancer cells from growing. It is not yet known whether AD 32 is     more effective with or without BCG after surgery for superficial bladder cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of AD 32 with or without BCG     after surgery in treating patients who have newly diagnosed or recurrent superficial bladder     cancer.   "
163605|NCT00003760|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have     stage III or stage IV pancreatic cancer that cannot be surgically removed.   "
163606|NCT00003761|"     This protocol is designed to evaluate the side effects of rV-DF3/MUC1 and to determine the     safest dose which should be used in the treatment of breast cancer.   "
163607|NCT00003762|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel     plus gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung     cancer.   "
163608|NCT00003763|"     RATIONALE: Diagnostic procedures using the drug radiolabeled folic acid and imaging may be     effective in detecting ovarian cancer.      PURPOSE: Diagnostic trial to study the effectiveness of radiolabeled folic acid plus imaging     in detecting ovarian cancer.   "
163609|NCT00003764|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known whether combining cyclophosphamide with fludarabine is more effective than     fludarabine alone in treating chronic lymphocytic leukemia.      PURPOSE: Randomized phase III trial to study the effectiveness of fludarabine with or without     cyclophosphamide in treating patients who have chronic lymphocytic leukemia that has not been     treated previously.   "
163610|NCT00003765|"     Phase I trial to study the effectiveness of O6-benzylguanine and carmustine in treating     children who have refractory CNS tumors. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may     kill more tumor cells.   "
163611|NCT00003766|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so     that it can be removed during surgery.      PURPOSE: Phase II trial to study the effectiveness of O6-benzylguanine followed by surgery in     treating patients who have solid tumors that can be removed during surgery.   "
163612|NCT00003768|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of combretastatin A4 phosphate in treating     patients who have advanced solid tumors that have not responded to previous therapy.   "
163778|NCT00003174|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of cladribine when     given with bryostatin 1 in treating patients with relapsed chronic lymphocytic leukemia.   "
163613|NCT00003769|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it     can be removed during surgery.      PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol followed by surgery in     treating patients who have stage II or stage III pancreatic cancer.   "
163614|NCT00003771|"     RATIONALE: Hormone replacement therapy is effective for relieving symptoms of menopause. It     is not yet known if hormone replacement therapy increases the risk of breast cancer     recurrence in women previously treated for early stage breast cancer.      PURPOSE: Randomized phase III trial to determine the risk of breast cancer recurrence in     women with previous early stage breast cancer who are receiving hormone replacement therapy     for menopause symptoms.   "
163615|NCT00003772|"     RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help     determine the intermediate- and long-term effects of treatment.      PURPOSE: This clinical trial studies the quality of life in patients with ovarian cancer.   "
163616|NCT00003773|"     RATIONALE: IM-862 may stop the growth of ovarian cancer by stopping blood flow to the tumor.      PURPOSE: Phase I trial to study the effectiveness of IM-862 in treating patients who have     recurrent ovarian cancer after treatment with chemotherapy and surgery.   "
163617|NCT00003775|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of leflunomide in treating patients who     have anaplastic astrocytoma in first relapse.   "
163618|NCT00003776|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug or combining chemotherapy with surgery     may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in     treating patients who have newly diagnosed metastatic osteosarcoma.   "
163619|NCT00003777|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more     than one drug and combining radiation therapy and surgery with chemotherapy may kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy,     and combination chemotherapy in treating patients who have recurrent head and neck cancer     that has been treated previously with radiation therapy.   "
163621|NCT00003779|"     RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system     and stop cancer cells from growing. It is not yet known which type of BCG is more effective     for bladder cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different types of     BCG in treating patients who have bladder cancer.   "
163622|NCT00003780|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Biological therapies use different ways to stimulate the immune     system and stop cancer cells from growing. It is not yet known whether chemotherapy is more     effective than biological therapy in treating patients with cancer of the pancreas.      PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine with     biological therapy in treating patients who have cancer of the pancreas that cannot be     surgically removed.   "
163623|NCT00003781|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial of docetaxel in treating patients who have stage IV prostate cancer     that has not responded to hormone therapy.   "
163624|NCT00003782|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving combination chemotherapy after surgery may kill any tumor     cells remaining following surgery. It is not yet known which regimen of combination     chemotherapy is more effective in treating breast cancer with positive axillary lymph nodes.      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of     combination chemotherapy in treating women who have undergone surgery for stage I, stage II,     or stage IIIA breast cancer with positive axillary lymph nodes.   "
163625|NCT00003783|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug and combining drugs in different     ways may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating children who     have very high risk acute lymphocytic leukemia.   "
163626|NCT00003784|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.     Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing     substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     monoclonal antibody therapy in treating patients who have newly diagnosed follicular     non-Hodgkin's lymphoma.   "
163627|NCT00003786|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with     metastatic or recurrent colorectal cancer.   "
163628|NCT00003787|"     RATIONALE: Dietary fats, fruits, vegetables, and fiber may affect the risk of breast cancer     recurrence.      PURPOSE: Randomized clinical trial to determine the effectiveness of a diet rich in     vegetables, fruit, and fiber and low in fat in women who have been treated for stage I, stage     II, or stage III breast cancer.   "
163629|NCT00003788|"     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to     light to kill tumor cells. It is not yet known if the addition of photodynamic therapy to     combined therapy with surgery, radiation therapy, and chemotherapy is more effective than     combined therapy alone for supratentorial gliomas.      PURPOSE: Randomized phase III trial to study the effectiveness of surgery, radiation therapy,     and chemotherapy with or without photodynamic therapy in treating patients who have newly     diagnosed or recurrent malignant supratentorial gliomas.   "
163630|NCT00003789|"     Randomized phase III trial to compare the effectiveness of hyperthermic isolated limb     perfusion of melphalan with or without tumor necrosis factor in treating patients who have     locally advanced melanoma of the arm or leg. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die. Heating melphalan to several     degrees above body temperature and infusing it only to the area around the tumor may kill     more tumor cells. It is not yet known whether combining melphalan with tumor necrosis factor     is more effective than melphalan alone in treating melanoma.   "
163631|NCT00003790|"     RATIONALE: Diagnostic procedures may improve the ability to detect residual disease.      PURPOSE: Clinical trial to detect the presence of residual disease in children who are     receiving therapy for acute myeloid leukemia or myelodysplastic syndrome.   "
163632|NCT00003792|"     RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the     body build an immune response and kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have metastatic melanoma.   "
163633|NCT00003793|"     RATIONALE: Determination of genetic markers for soft tissue sarcoma or rhabdomyosarcoma may     help doctors identify patients who are at risk for therapy-related leukemia.      PURPOSE: Clinical trial to study genetic testing of children with soft tissue sarcoma or     rhabdomyosarcoma to identify children who are at risk of developing leukemia from the     chemotherapy used to treat sarcoma.   "
163634|NCT00003794|"     RATIONALE: Quality-of-life assessment of patients undergoing cancer treatment may help     determine the intermediate- and long-term effects of treatment in patients with cancer.      PURPOSE: This clinical trial studies the quality of life in patients with previously treated     ovarian cancer.   "
163635|NCT00003795|"     RATIONALE: Quality-of-life assessment in cancer survivors may help determine the long-term     effects of having had gynecologic cancer and may help improve the quality of life for future     cancer survivors.      PURPOSE: This clinical trial is studying the quality of life in survivors of gynecologic     cancer.   "
163636|NCT00003796|"     Phase II trial to study the effectiveness of irofulven in treating patients who have     metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die.   "
163637|NCT00003797|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine and trastuzumab in treating     patients who have metastatic cancer of the pancreas that overexpresses HER2/neu.   "
163638|NCT00003798|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy.      PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation     therapy in treating patients who have cancer of the pancreas that cannot be removed by     surgery.   "
163639|NCT00003799|"     Phase I trial to study the effectiveness of radiation therapy plus chemotherapy followed by     surgery and additional chemotherapy in treating patients who have advanced nonmetastatic     primary cancer of the rectum. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to     damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may be an     effective treatment for rectal cancer   "
163640|NCT00003800|"     RATIONALE: Diagnostic procedures may improve a doctor's ability to predict the recurrence of     testicular cancer.      PURPOSE: Diagnostic trial to detect the risk of recurrent disease in patients who have stage     I testicular cancer and who have undergone orchiectomy within the previous 12 weeks.   "
163641|NCT00003801|"     RATIONALE: Cancer treatment may have risks that affect health outcomes later. It is not yet     known what health outcomes may be related to previous treatment for rhabdomyosarcoma.      PURPOSE: Study to determine health outcomes in patients who have survived 5 years after     receiving treatment for rhabdomyosarcoma on the Intergroup Rhabdomyosarcoma Study Group     protocols.   "
163642|NCT00003802|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients     who have metastatic skin or eye melanoma.   "
163643|NCT00003803|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy used high-energy x-rays to damage tumor cells. It     is not yet know whether chemotherapy followed by radiation therapy is more effective than     chemotherapy given with radiation therapy for non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of     chemotherapy and radiation therapy in treating patients who have unresectable stage I, stage     II, or stage III non-small cell lung cancer.   "
163644|NCT00003804|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. It is not yet known which regimen of chemotherapy is more     effective for stage I Wilms' tumor.      PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and surgery in     treating children who are at risk of or who have stage I Wilms' tumor.   "
163645|NCT00003805|"     RATIONALE: Antibiotic therapy may prevent the development of infection in patients with     hematologic cancer and the persistent fever caused by a low white blood cell count. It is not     yet known which regimen of antibiotics is most effective in preventing infection in these     patients.      PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam     with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or     Hodgkin's disease.   "
163646|NCT00003808|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of theophylline in treating patients who     have in situ, stage I, or stage II chronic lymphocytic leukemia.   "
163779|NCT00003175|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of fluorouracil given as a continuous     infusion in treating patients with recurrent or metastatic bladder cancer.   "
163647|NCT00003809|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. It is not yet     known whether cisplatin plus monoclonal antibody therapy is more effective than cisplatin     alone for metastatic or recurrent head and neck cancer.      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of cisplatin     with or without monoclonal antibody in treating patients who have metastatic or recurrent     head and neck cancer.   "
163648|NCT00003810|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more that one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and docetaxel in     treating patients who have locally advanced or metastatic cancer of the pancreas.   "
163649|NCT00003811|"     RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they     stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from     the side effects of chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin, etoposide, and     bleomycin plus amifostine in treating children who have malignant germ cell tumors.   "
163650|NCT00003812|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug and giving them before and with radiation therapy may be an     effective treatment for limited-stage small cell lung cancer.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in     treating patients who have limited-stage small cell lung cancer.   "
163651|NCT00003814|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if eflornithine is more effective than no     further therapy in treating bladder cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of eflornithine in     treating patients who have newly diagnosed or recurrent bladder cancer.   "
163652|NCT00003815|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy     drugs and kill more cancer cells.      PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and radiation     therapy plus bone marrow transplantation in treating patients who have aggressive     non-Hodgkin's lymphoma.   "
182493|NCT00224692|"     Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by     patient-controlled analgesia with morphine   "
163653|NCT00003816|"     RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor stem cell     helps stop the growth of cancer or abnormal cells. It may also stop the patient's immune     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are     infused into the patient they may help the patient's bone marrow make stem cells, red blood     cells, white blood cells, and platelets. It is not yet known which combination chemotherapy     regimen is most effective when given before a donor stem cell transplant in treating aplastic     anemia or hematologic cancer.      PURPOSE: This phase II/III trial is studying different combination chemotherapy regimens to     compare how well they work when given before donor stem cell transplant in treating patients     with aplastic anemia or hematologic cancer.   "
163654|NCT00003817|"     RATIONALE: Pressure or nerve stimulation applied to an acupuncture point on the inside of the     wrist may help control nausea and vomiting during chemotherapy.      PURPOSE: Randomized phase II trial to study the effectiveness of acupressure and     acustimulation wrist bands in treating nausea and vomiting in patients undergoing     chemotherapy for cancer.   "
163655|NCT00003819|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy given with QS21 in     treating patients who have progressive prostate cancer.   "
163656|NCT00003820|"     Phase 2 trial to study the effectiveness of rituximab in treating patients who have     lymphocyte-predominant Hodgkin's lymphoma.   "
163657|NCT00003821|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of aminopterin in treating patients who     have refractory or recurrent endometrial cancer.   "
163658|NCT00003822|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of SR-45023A in treating patients who have     advanced solid tumors.   "
163659|NCT00003824|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. It is not yet known whether ciprofloxacin is more     effective than cephalexin in preventing cancer recurrence in patients who are undergoing     surgery to treat bladder cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of ciprofloxacin with that     of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for     bladder cancer.   "
163660|NCT00003825|"     RATIONALE: Pentosan polysulfate may be effective in treating side effects of radiation     therapy to the abdomen or pelvis. It is not yet known whether pentosan polysulfate is more     effective than no further therapy for treating gastrointestinal disturbance caused by     previous radiation therapy.      PURPOSE: Randomized phase III trial to determine the effectiveness of pentosan polysulfate in     treating patients who have inflammation of the rectum, diarrhea, or blood in stools caused by     previous radiation therapy to the abdomen and pelvis.   "
163661|NCT00003827|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more cancer cells.     Chemoprotective drugs such as amifostine may protect normal cells from the side effects of     chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combining topotecan and cytarabine     given with amifostine in treating patients who have myelodysplastic syndrome.   "
163662|NCT00003828|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients who     have stage IV melanoma that has been previously treated.   "
202724|NCT00502385|"     The study will be conducted across multiple European centres to assess the safety and     tolerability of multiple doses of AZD2171 in patients with AML.   "
163663|NCT00003829|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Alternating treatment with more than one drug may kill more     cancer cells.      PURPOSE: Phase II trial to study the effectiveness of fludarabine alternating with     cyclophosphamide in treating patients who have previously untreated chronic lymphocytic     leukemia.   "
163664|NCT00003830|"     RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help     plan more effective surgery for breast cancer. It is not yet known if surgery to remove the     sentinel lymph nodes is more effective with or without removal of the lymph nodes in the     armpit in treating breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the     sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women     who have breast cancer.   "
163665|NCT00003831|"     RATIONALE: Surgical removal of all lymph nodes in the chest may kill cancer cells that have     spread from tumors in the lung. It is not yet known whether complete removal of all lymph     nodes in the chest is more effective than removal of selected lymph nodes in treating     patients who have stage I or stage II non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of complete removal of all     lymph nodes in the chest with that of selected removal of lymph nodes during lung cancer     surgery in treating patients who have stage I or stage II non-small cell lung cancer.   "
163666|NCT00003832|"     Phase II trial to study the effectiveness of broxuridine in treating patients who are     undergoing surgery for stage I or stage II prostate cancer. Broxuridine may help doctors     determine the rate of growth of prostate tumors and help them plan effective treatment   "
163667|NCT00003833|"     RATIONALE: Genetic studies may help in understanding the genetic processes that cause some     types of cancer.      PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III     colon cancer.   "
163668|NCT00003834|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients with liver metastases from colorectal cancer.   "
163752|NCT00003025|"     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune     response to and kill tumor cells. Combining vaccine therapy with surgery may be an effective     treatment for pancreatic cancer.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients     with stage I or stage II pancreatic cancer that has been surgically removed.   "
163669|NCT00003835|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining more than one drug may kill more tumor cells. It is not yet known     which chemotherapy regimen is more effective for stage III colon cancer. Randomized phase III     trial to compare the effectiveness of fluorouracil plus leucovorin with or without irinotecan     in treating patients who have undergone surgery for stage III colon cancer.   "
163670|NCT00003837|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have     relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.   "
163671|NCT00003838|"     The are a variety of cancerous diseases of the blood and bone marrow that can be potentially     cured by bone marrow transplantation (BMT). Diseases like leukemia, lymphoma, and multiple     myeloma are among the conditions that can be treated with BMT.      Some patients with these diseases can be treated with medical chemotherapy alone. However,     patients who relapse following chemotherapy are usually not curable with additional     chemotherapy treatments. The only option known to provide a potential cure if this occurs is     BMT.      Allogenic transplants are cells collected from relatives of the patient. The transplant     requires additional high intensity chemotherapy and radiation in order to destroy cancerous     cells. In the process, many normal bone marrow cells are also destroyed. This is the reason     for transplanting stem cells. The stem cells help to build new functioning bone marrow, red     cells, white cells, and platelets. In addition, the immune cells from the donor are implanted     into the recipient s body and help to fight off infection and kill remaining cancerous cells.      Unfortunately, the powerful doses of chemotherapy and radiation therapy associated with     allogenic BMT have toxic side effects and often make BMTs too dangerous to attempt in many     patients.      In order to reduce the complications of BMT, and make it a safer available option for     patients with cancers of the blood and bone marrow, researchers have developed a new approach     to the BMT.      In this study researchers plan to use stem cells collected from the blood stream of patient s     relatives rather than from the bone marrow (blood progenitor/stem cell transplant). In     addition, researchers plan to use low doses of chemotherapy and no radiation therapy to     reduce side effects. The majority of the cancer killing effect will be the responsibility of     the stem cell transplant rather than the chemotherapy.   "
163672|NCT00003840|"     RATIONALE: DTGM fusion protein may be able to locate cancer cells and stop them from growing.      PURPOSE: Phase I/II trial to study the effectiveness of DTGM fusion protein in treating     patients who have recurrent or refractory acute myeloid leukemia.   "
163673|NCT00003842|"     RATIONALE: IL-4(38-37)-PE38KDEL immunotoxin may locate tumor cells and kill them without     harming normal cells. This may be an effective treatment for recurrent malignant astrocytoma.      PURPOSE: Phase I trial to study the effectiveness of IL-4(38-37)-PE38KDEL immunotoxin in     treating patients who have recurrent malignant astrocytoma.   "
163674|NCT00003843|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who     have colorectal cancer.   "
163675|NCT00003846|"     RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy     use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral     stem cell transplantation may allow doctors to give higher doses of radiation therapy and     chemotherapy and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy, chemotherapy and     peripheral stem cell transplantation in treating patients with primitive neuroectodermal     tumors.   "
163676|NCT00003847|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy for the     treatment of patients who have recurrent small cell lung cancer following treatment.   "
163677|NCT00003849|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them.      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have     non-Hodgkin's lymphoma or Hodgkin's disease.   "
163678|NCT00003850|"     Phase II trial to study the effectiveness of thalidomide in treating patients with recurrent     or metastatic head and neck cancer. Thalidomide may stop the growth of head and neck cancer     by stopping blood flow to the tumor.   "
163709|NCT00003884|"     RATIONALE: Zoledronate may help to relieve some of the symptoms caused by bone metastases. It     is not yet known if zoledronate is more effective than no further therapy in relieving     symptoms of bone metastases or preventing disease progression.      PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in treating     patients who have solid tumors that have spread to the bone.   "
163679|NCT00003851|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Pancreatic enzymes may help kill cancer cells. It is not yet known     if gemcitabine is more effective than pancreatic enzyme therapy plus specialized diet for     pancreatic cancer.      PURPOSE: This clinical trial is comparing the effectiveness of gemcitabine with that of     pancreatic enzyme therapy plus specialized diet (Gonzalez regimen) in treating patients who     have stage II, stage III, or stage IV pancreatic cancer.   "
163680|NCT00003852|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow patients to tolerate higher doses of chemotherapy and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral     stem cell transplantation in treating patients who have germ cell tumors that have not     responded to previous chemotherapy.   "
163681|NCT00003853|"     RATIONALE: 4'-Iodo-4'-deoxydoxorubicin may improve organ dysfunction and ease symptoms caused     by primary systemic amyloidosis.      PURPOSE: Phase II trial to study the effectiveness of 4'-iodo-4'-deoxydoxorubicin in treating     patients who have primary systemic amyloidosis.   "
163682|NCT00003854|"     RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect     and determine the extent of cancer.      PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow     metastases in women who have stage I or stage IIA breast cancer.   "
163683|NCT00003855|"     RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have     spread from tumors in the breast.      PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in     the armpit in treating women who have stage I or stage IIA breast cancer.   "
163717|NCT00002987|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor     cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     plus radiation therapy with radiation therapy alone in treating patients with early-stage     Hodgkin's disease.   "
163684|NCT00003856|"     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to     light to kill tumor cells. This may be an effective palliative treatment for head and neck     cancer.      PURPOSE: Phase II trial to study the effectiveness of photodynamic therapy for palliative     treatment in patients who have recurrent, refractory, or second primary head and neck cancer     that cannot be treated with surgery or radiation therapy.   "
163685|NCT00003857|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can     stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast     cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if     radiation therapy is more effective than observation, with or without tamoxifen, in treating     ductal carcinoma in situ.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with     that of observation, with or without tamoxifen, in treating women who have ductal carcinoma     in situ.   "
163686|NCT00003858|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving chemotherapy after surgery may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of mitoxantrone given after surgery in     treating patients who have prostate cancer that is at high risk for recurrence.   "
163687|NCT00003859|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It     is not yet known whether undergoing surgery plus radiation therapy is more effective with or     without chemotherapy for primitive neuroectodermal tumors of the CNS.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus radiation     therapy with or without chemotherapy in treating patients who have primitive neuroectodermal     tumors of the CNS.   "
163688|NCT00003860|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     peripheral stem cell transplantation in treating patients who have small cell lung cancer.   "
163689|NCT00003861|"     This research trial studies molecular genetic features in blood and tissue samples from     patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia.     Studying samples of blood and tissue from patients with acute lymphoblastic leukemia or acute     promyelocytic leukemia in the laboratory may help doctors identify and learn more about     biomarkers related to cancer.   "
163690|NCT00003862|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in     treating patients who have stomach cancer.   "
163691|NCT00003863|"     RATIONALE: Determination of genetic markers for aggressive non-Hodgkin's lymphoma may help     identify patients with this disease and help predict the outcome of treatment.      PURPOSE: Diagnostic study to determine the genetic markers in patients who have aggressive     non-Hodgkin's lymphoma.   "
163692|NCT00003864|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating     patients who have advanced cancer of the esophagus.   "
163693|NCT00003865|"     RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using     toremifene may fight ovarian cancer by reducing the production of estrogen.      PURPOSE: Randomized phase II trial to study the effectiveness of toremifene in treating     patients who have recurrent or refractory ovarian cancer.   "
163694|NCT00003867|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating     patients who have solid tumors that have not responded to previous treatment.   "
163710|NCT00003885|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have recurrent or refractory acute leukemia, chronic myeloid leukemia, myelodysplasia,     lymphoma, or myeloma.   "
163695|NCT00003868|"     RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and either kill them or     deliver radioactive cancer-killing substances to them without harming normal cells. Drugs     used in chemotherapy work in different ways to stop cancer cells from dividing so they stop     growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Donor stem     cell transplantation may be able to replace immune cells that were destroyed by radiolabeled     monoclonal antibody therapy, chemotherapy and radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of combining radiolabeled monoclonal     antibody with cyclophosphamide and total-body irradiation followed by donor stem cell     transplantation in treating patients who have advanced acute myeloid leukemia.   "
163696|NCT00003869|"     Randomized phase III trial to determine the effectiveness of carboxyamidotriazole in treating     patients who have stage III or stage IV non-small cell lung cancer. Chemotherapeutic agents     are modestly effective for the treatment of advanced lung cancer, with rapid tumor relapse     and growth even after initial response to therapy. It is not yet known whether     carboxyamidotriazole is more effective than no further treatment after standard chemotherapy     for non-small cell lung cancer.   "
163697|NCT00003870|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy     use different ways to stop cancer cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell transplantation     may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy     used to kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy,     cyclophosphamide, and total-body irradiation followed by peripheral stem cell transplantation     in treating patients who have advanced recurrent acute lymphocytic leukemia.   "
163699|NCT00003873|"     Randomized phase III trial to compare the effectiveness of fluorouracil given by infusion     with that of fluorouracil plus eniluracil given by mouth in treating patients who have     metastatic, recurrent, or residual advanced colorectal cancer. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. It is not yet     known if fluorouracil is more effective with or without eniluracil for advanced colorectal     cancer   "
163700|NCT00003874|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances without harming normal cells.      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in     treating patients who have lymphoma or leukemia.   "
163701|NCT00003875|"     This phase II trial studies the side effects and how well giving busulfan and etoposide     followed by peripheral blood stem cell transplant (PBSCT) and low-dose aldesleukin works in     treating patients with acute myeloid leukemia (AML). Drugs used in chemotherapy, such as     busulfan and etoposide, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. A PBSCT may be able to replace     blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to     be given so that more cancer cells are killed. Aldesleukin may stimulate the white blood     cells to kill cancer cells. Giving busulfan and etoposide together followed by PBSCT and     aldesleukin may be an effective treatment for AML.   "
163702|NCT00003876|"     RATIONALE: Internal radiation uses high-energy radiation to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining internal radiation therapy with chemotherapy implants may kill remaining tumor     cells following surgery.      PURPOSE: Phase I trial to study the effectiveness of internal radiation therapy plus     carmustine implants in treating patients who have recurrent or refractory malignant glioma.   "
163703|NCT00003877|"     RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of     chemotherapy and kill more tumor cells. It is not yet known whether Stromagen improves the     success of stem cell transplantation in women with breast cancer.      PURPOSE: Randomized phase I/II trial to study the effectiveness of Stromagen during stem cell     transplantation following chemotherapy in treating women with metastatic breast cancer.   "
163704|NCT00003878|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving the drugs in different ways may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating     patients who have brain metastases and who are undergoing surgery to remove the tumor.   "
163705|NCT00003880|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with gene therapy using SCH-58500 may kill     more tumor cells.      PURPOSE: Randomized phase II/III trial to determine the effectiveness of paclitaxel plus     carboplatin with or without SCH-58500 in treating patients who have newly diagnosed stage III     ovarian or stage III primary peritoneal cancer with residual disease following surgery to     remove the tumor.   "
163706|NCT00003881|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     monoclonal antibody therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab     plus carboplatin and paclitaxel in treating patients who have advanced non-small cell lung     cancer.   "
163707|NCT00003882|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of anhydrovinblastine in treating patients     who have advanced recurrent solid tumors.   "
163708|NCT00003883|"     RATIONALE: Giving itraconazole or fluconazole may be effective in preventing infections in     patients undergoing peripheral stem cell or bone marrow transplantation. It is not yet known     whether itraconazole is more effective than fluconazole for preventing infections.      PURPOSE: Randomized phase III trial to compare the effectiveness of itraconazole with     fluconazole to prevent infections in patients undergoing peripheral stem cell or bone marrow     transplantation.   "
163711|NCT00003887|"     RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with     cancer that has recurred following bone marrow or peripheral stem cell transplantation.      PURPOSE: Phase II trial to study the effectiveness of donated white blood cells in treating     patients who have relapsed cancer following transplantation of donated bone marrow or     peripheral stem cells.   "
163712|NCT00003888|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug and combining chemotherapy with radiation therapy may kill more     tumor cells. It is not yet known which regimen of combination chemotherapy is more effective     for advanced head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of     combination chemotherapy plus radiation therapy in treating patients who have advanced head     and neck cancer.   "
163713|NCT00003890|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of MG98 in treating patients who have     advanced solid tumors.   "
163714|NCT00002984|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than on drug and combining chemotherapy with radiation therapy may kill more     tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus     radiation therapy in treating patients with advanced or metastatic cancer of the esophagus.   "
163715|NCT00002985|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether doxorubicin is more effective than     daunorubicin for AIDS-related Kaposi's sarcoma.      PURPOSE: Randomized double-blinded phase III trial to determine if doxorubicin is more     effective than daunorubicin in treating patients who have AIDS-related Kaposi's sarcoma.   "
163719|NCT00002989|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of idarubicin plus     peripheral stem cell transplantation using the patient's own or donated stem cells in     treating patients with leukemia or myelodysplastic syndrome.   "
163720|NCT00002990|"     RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system     and stop cancer cells from growing.      PURPOSE: This randomized phase III trial is studying four different regimens of BCG and     comparing how well they work in treating patients who have undergone surgery for bladder     cancer.   "
163721|NCT00002993|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with     mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer     of the uterus.   "
163722|NCT00002994|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill solid tumor     cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Pilot study to examine the effectiveness of interleukin-2 plus monoclonal antibody     in treating patients who have solid tumors.   "
163723|NCT00002995|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     tumor cells. It is not yet known whether chemotherapy is more effective with or without     radiation therapy in treating patients who have rhabdomyosarcoma.      PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without     radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma.   "
163724|NCT00002996|"     RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably.      PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with     chronic neuropathic pain from cancer or AIDS.   "
163725|NCT00002997|"     RATIONALE: Cryosurgery for liver metastases may have fewer side effects and improve recovery.      PURPOSE: Phase II trial to study the effectiveness of cryosurgery for patients with     unresectable liver metastases from colorectal cancer.   "
163726|NCT00002998|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine and cisplatin in treating     patients with metastatic breast cancer that has not responded to systemic therapy.   "
163727|NCT00002999|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug and combining chemotherapy with radiation therapy may kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in     treating patients with advanced cancer of the nasopharynx.   "
164723|NCT00005298|"     To determine whether airway inflammation secondary to inhalation of specific allergens and     other environmental agents and functional imbalance of the autonomic nervous system played     important roles in asthma and chronic bronchitis.   "
163728|NCT00003000|"     RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine     in different ways may offer more pain relief.      PURPOSE: This randomized clinical trial is studying how well morphine injected directly into     the underarm area works compared with morphine injected into the back of the shoulder in     treating pain in patients who have breast cancer and who are undergoing axillary lymph node     dissection.   "
163729|NCT00003001|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting     of fluorouracil, leucovorin, and gemcitabine in treating patients with recurrent or     metastatic colorectal cancer.   "
163730|NCT00003002|"     RATIONALE: Vaccines made from the HER2/neu antigen may make the body build an immune response     and kill tumor cells. Colony-stimulating factors such as GM-CSF increase the number of immune     cells found in bone marrow or peripheral blood.      PURPOSE: Phase I trial to study the effectiveness of HER-2/neu vaccine plus GM-CSF in     treating patients who have stage III or stage IV breast cancer, stage III or stage IV ovarian     cancer, or stage III or stage IV non-small cell lung cancer.   "
163731|NCT00003003|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Some cancers become resistant to chemotherapy drugs. Combining     mitomycin with a chemotherapy drug may reduce resistance to the drug and allow the cancer     cells to be killed.      PURPOSE: Phase I trial to study the effectiveness of mitomycin and mitoxantrone in treating     patients with acute myelogenous leukemia and to determine whether mitomycin can reduce the     cancer's resistance to chemotherapy.   "
163732|NCT00003004|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with paclitaxel     and cisplatin plus flavopiridol in treating patients who have refractory or recurrent solid     tumors.   "
163733|NCT00003005|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of chemotherapy consisting of cordycepin     plus pentostatin in treating patients with refractory acute lymphocytic or chronic     myelogenous leukemia.   "
163734|NCT00003006|"     RATIONALE: Detecting very early metastases in bone marrow and/or lymph nodes may help doctors     plan better treatment for non-small cell lung cancer.      PURPOSE: Clinical trial to detect the presence of metastatic cancer in patients with stage I     non-small cell lung cancer that has not been previously treated.   "
164751|NCT00005327|"     To conduct a prospective study aimed at the early detection and treatment of cerebral     vascular disease prior to irreversible brain injury in young children with sickle cell anemia     (SCA).   "
163735|NCT00003007|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give     higher doses of chemotherapy drugs and kill more tumor cells. Interferon alfa may interfere     with the growth of cancer cells.      PURPOSE: Phase II trial to determine the effectiveness of giving interferon alfa after     chemotherapy and peripheral stem cell transplantation to patients who have stage III or stage     IV multiple myeloma and who have been treated with high-dose melphalan.   "
163736|NCT00003008|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with     AIDS-related Kaposi's sarcoma.   "
163737|NCT00003009|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.     Giving interleukin-2 in different ways may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of inhaled interleukin-2 in treating     patients with metastatic or unresectable cancer.   "
163738|NCT00003010|"     RATIONALE: Marimastat may stop the growth of breast cancer by stopping blood flow to the     tumor. It is not known whether chemotherapy is more effective with or without marimastat for     breast cancer.      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of marimastat     with that of no further therapy in treating women who have metastatic breast cancer that is     responding or stable after chemotherapy.   "
163739|NCT00003011|"     RATIONALE: Marimastat may stop the growth of lung cancer by stopping blood flow to the tumor.     It is not yet known if marimastat is an effective treatment for small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of marimastat with a placebo     following chemotherapy in treating patients who have small cell lung cancer.   "
163740|NCT00003012|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which combination chemotherapy regimen is more     effective following surgery for breast cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy     consisting of cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin in     treating women who have early stage breast cancer.   "
163741|NCT00003013|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It     is not yet known which treatment regimen is more effective for breast cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy plus surgery     in treating women who have breast cancer.   "
163742|NCT00003014|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It     is not yet known whether chemotherapy is more effective than radiation therapy for testicular     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with that of     radiation therapy in treating patients who have stage I testicular cancer.   "
163743|NCT00003015|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus     vincristine in treating children and adolescents with low grade glioma.   "
164604|NCT00004030|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of VX-853 in treating patients who have     solid tumors who are receiving liposomal doxorubicin.   "
163744|NCT00003016|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known     if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative     treatment for breast cancer.      PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period     of time to see how well it works compared to giving tamoxifen over a shorter period of time     in treating patients who have had a breast tumor removed.   "
163745|NCT00003017|"     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by     stimulating a person's white blood cells to kill cancer cells in the cervix.      PURPOSE: Phase II trial to study the effectiveness of interleukin-12 in treating patients who     have advanced or recurrent cancer of the cervix.   "
163746|NCT00003018|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.     Chemotherapy following surgery may be an effective treatment for pancreatic cancer.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients with stage II or stage III pancreatic cancer that has not been surgically removed.   "
163747|NCT00003019|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy with vinblastine and     methotrexate in treating children who have desmoid tumors that are recurrent or untreatable     with surgery or radiation therapy.   "
163748|NCT00003020|"     RATIONALE: LMB-7 immunotoxin can locate tumor cells and kill them without harming normal     cells.      PURPOSE: Phase I trial to study the effectiveness of LMB-7 immunotoxin in treating patients     who have leptomeningeal metastases metastases.   "
163749|NCT00003021|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of bizelesin in treating patients who have     advanced cancer.   "
163750|NCT00003022|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have leptomeningeal metastases.   "
163751|NCT00003023|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Combining monoclonal antibody     A1G4 with BCG may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in     treating patients with cancer.   "
163753|NCT00003026|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using     triptorelin may fight prostate cancer by reducing the production of androgens.      PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy     and triptorelin with no further treatment in treating patients who have advanced prostate     cancer previously treated with radiation therapy and 6 months of androgen suppression.   "
163754|NCT00003027|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill     melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet     known whether combination chemotherapy plus interleukin-2 and interferon alfa is more     effective than combination chemotherapy alone for metastatic melanoma.      PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without     interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that     cannot be treated by surgery.   "
163755|NCT00003028|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have     recurrent or refractory solid tumors.   "
163756|NCT00003029|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving drugs in different ways may     kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more     effective than fluorouracil alone in treating patients with metastatic cancer of the     pancreas.      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or     without cisplatin in treating patients who have advanced or metastatic cancer of the     pancreas.   "
163757|NCT00003031|"     RATIONALE: Antifungal therapy with voriconazole or amphotericin B may be an effective     treatment for aspergillosis. It is not yet known whether voriconazole is more effective than     amphotericin B in treating patients with aspergillosis.      PURPOSE: Randomized phase III trial to compare the effectiveness of voriconazole with     amphotericin B in treating patients with aspergillosis.   "
163758|NCT00003032|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It     is not yet known whether standard therapy is more effective than high dose chemotherapy for     breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy     plus peripheral stem cell transplantation with that of standard therapy in treating women     with metastatic or recurrent breast cancer that has responded to previous chemotherapy.   "
163759|NCT00003034|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. It is not yet known whether Onconase plus doxorubicin     is more effective than doxorubicin alone in treating patients with malignant mesothelioma.      PURPOSE: This randomized phase III trial is studying doxorubicin alone to see how well it     works compared to doxorubicin and Onconase in treating patients with malignant mesothelioma.   "
164724|NCT00005299|"     To quantify the influence of genetic and environmental factors on the development of sleep     apnea.   "
163760|NCT00003035|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving the drugs in different ways     may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of doxorubicin with     paclitaxel in treating women who have locally advanced breast cancer.   "
163761|NCT00003037|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy with     docetaxel, gemcitabine, and cisplatin as induction therapy in treating patients with stage     III non-small cell lung cancer.   "
163762|NCT00003038|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with suramin     plus doxorubicin in treating patients with advanced solid tumors.   "
163763|NCT00003039|"     Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent     intermediate-grade or high-grade non-Hodgkin's lymphoma or mantle cell lymphoma. Drugs used     in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die.   "
163764|NCT00003040|"     RATIONALE: Laser surgery for cancer of the larynx may have fewer side effects and improve     recovery. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining     radiation therapy and laser surgery may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of laser surgery plus radiation therapy in     treating patients with early stage cancer of the larynx.   "
163765|NCT00003041|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating women who     have refractory metastatic breast cancer.   "
163766|NCT00003042|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation     work in treating patients with stage IIIB breast cancer.   "
163767|NCT00003044|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving drugs in different ways may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of cisplatin and epinephrine administered     directly into the tumor in treating patients who have primary liver cancer that cannot be     removed during surgery.   "
163787|NCT00003185|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing.      PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients     with glioblastoma multiforme.   "
163768|NCT00003045|"     Hyperthermia therapy may kill prostate cancer cells by heating them to several degrees above     body temperature. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining     hyperthermia with radiation therapy may kill more tumor cells.      The purpose of this study is to determine the ability of hyperthermia when combined with     radiation therapy and in some patients hormonal therapy to control prostate cancer.   "
163769|NCT00003162|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known which radiation therapy regimen is more effective for bone metastases.      PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in     treating patients who have bone metastases from breast or prostate cancer.   "
163770|NCT00003163|"     RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of     chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation in     treating patients who have multiple myeloma or other B-cell cancers.   "
163771|NCT00003165|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving drugs in different forms may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of doxorubicin in treating women with     advanced metastatic breast cancer.   "
163772|NCT00003166|"     This phase I trial is studying the side effects and best dose of bryostatin-1 when given     together with vincristine in treating patients with chronic lymphocytic leukemia,     non-Hodgkin's lymphoma, or multiple myeloma. Drugs used in chemotherapy use different ways to     stop cancer cells from dividing so they stop growing or die. Combining more than one drug may     kill more cancer cells   "
163773|NCT00003167|"     Phase I trial to study the effectiveness of gene therapy in treating patients with advanced     bladder cancer. Inserting the p53 gene into a person's bladder cancer cells may improve the     body's ability to fight cancer   "
163774|NCT00003170|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Glutamine may be     an effective treatment for acute diarrhea caused by radiation therapy. It is not known if     glutamine is an effective treatment for acute diarrhea caused by radiation therapy.      PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of     glutamine in preventing acute diarrhea in patients who have pelvic cancer and who are     receiving radiation therapy.   "
163775|NCT00003171|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with     myelodysplastic syndrome.   "
163776|NCT00003172|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving drugs in different combinations and combining them with     interferon alfa and G-CSF may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of different combination     chemotherapy regimens in treating patients with advanced stomach cancer.   "
163777|NCT00003173|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose thiotepa plus peripheral stem     cell transplantation in treating patients with refractory solid tumors.   "
164725|NCT00005300|"     To continue to follow the newborn cohort and the over-35 years of age cohort from the     Cooperative Study of Sickle Cell Disease (CSSCD), a study of the natural history of sickle     cell disease.   "
163780|NCT00003176|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of temozolomide and carmustine in treating     patients with anaplastic glioma.   "
163781|NCT00003178|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of idarubicin and cladribine in treating     children who have recurrent acute myeloid leukemia.   "
163782|NCT00003179|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of surgery with or without medroxyprogesterone     may be an effective way to prevent the development of endometrial cancer in patients who have     endometrial hyperplasia.      PURPOSE: Phase II trial to compare the effectiveness of surgery alone with that of     medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have     endometrial hyperplasia.   "
163783|NCT00003181|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill     cancer cells. Combining chemotherapy with interleukin-2 and GM-CSF may be a more effective     treatment for kidney cancer.      PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2, vinblastine,     and GM-CSF in treating patients with metastatic kidney cancer.   "
163784|NCT00003182|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of cisplatin and gemcitabine in treating     patients with advanced squamous cell cancer of the head and neck that cannot be surgically     removed.   "
163785|NCT00003183|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with G-CSF may make tumor cells more     sensitive to the chemotherapy drug and may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of mitoxantrone plus G-CSF in treating     patients with metastatic prostate cancer that has not responded to hormone therapy.   "
163786|NCT00003184|"     RATIONALE: Vaccines made from breast cancer cells may make the body build an immune response     to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccines made from breast cancer cells     in treating women with metastatic breast cancer.   "
164857|NCT00005433|"     To examine the appropriateness of angiographic and ultrasound endpoints as predictors of     subsequent clinical coronary events. Follow-up data from the Cholesterol Lowering in     Atherosclerosis Study (CLAS) were used.   "
163788|NCT00003186|"     RATIONALE: Diagnostic procedures, such as lymphography, may improve the identification of     patients with metastatic colorectal cancer.      PURPOSE: Clinical trial to study the effectiveness of lymphography in determining the     presence or absence of metastatic colorectal cancer in patients.   "
163789|NCT00003187|"     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy used to kill cancer cells. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Eliminating the T cells from the donor cells before transplanting them may prevent this from     happening.      PURPOSE: Randomized phase II/III trial to compare the effectiveness of conventional bone     marrow transplantation with T cell-depleted bone marrow transplantation in treating patients     who have leukemia, myelodysplasia, or lymphoblastic lymphoma.   "
163790|NCT00003190|"     Randomized phase III trial to compare the effectiveness of combination chemotherapy with or     without PSC 833 followed by interleukin-2 or no further therapy in treating older patients     who have acute myeloid leukemia. Some cancers become resistant to chemotherapy drugs.     Combining PSC 833 with more than one chemotherapy drug may reduce resistance to the drugs and     allow the cancer cells to be killed. Combining interleukin-2 with combination chemotherapy     plus PSC 833 may kill more cancer cells.   "
163791|NCT00003191|"     Phase I trial to study the effectiveness of fenretinide in treating children who have solid     tumors that have not responded to standard therapy. Drugs used in chemotherapy use different     ways to stop tumor cells from dividing so they stop growing or die.   "
163792|NCT00003192|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients     with locally advanced, metastatic, or recurrent cancer of the stomach or esophagus.   "
163793|NCT00003193|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of     chemotherapy.      PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel and radiation therapy plus     chemoprotection with amifostine in treating patients with stage III or stage IV head and neck     cancer.   "
163794|NCT00003194|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and peripheral     stem cell transplantation in treating patients who have recurrent or refractory solid tumors.   "
163795|NCT00003195|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Interferon alfa may interfere with the growth of cancer cells.      PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, busulfan, and     interferon alfa followed by peripheral stem cell or bone marrow transplantation in treating     patients with multiple myeloma.   "
163808|NCT00003210|"     Phase II trial to study the effectiveness of interleukin-12 in treating patients with     previously treated non-Hodgkin's lymphoma or Hodgkin's disease. Interleukin-12 may kill tumor     cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to     kill lymphoma cells.   "
163796|NCT00003196|"     This pilot clinical trial studies low-dose total body irradiation and donor peripheral blood     stem cell transplant followed by donor lymphocyte infusion in treatment patients with     non-Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma. Giving total-body     irradiation before a donor peripheral blood stem cell transplant helps stop the growth of     cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells.     When healthy stem cells from a donor are infused into the patient they may help the patient's     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Once the     donated stem cells begin working, the patient's immune system may see the remaining cancer     cells as not belonging in the patient's body and destroy them. Giving an infusion of the     donor's white blood cells (donor lymphocyte infusion) may boost this effect.   "
163797|NCT00003197|"     RATIONALE: Green tea extract contains ingredients that may slow the growth of certain     cancers, as well as prevent the development of new cancers.      PURPOSE: Phase I trial to study the effectiveness of green tea extract in treating patients     with advanced solid tumors that are refractory to standard therapy.   "
163798|NCT00003198|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of chemotherapy with ifosfamide and     topotecan in treating patients with refractory solid tumors.   "
163799|NCT00003199|"     This phase II trial studies how well giving combination chemotherapy and peripheral blood     stem cell transplant followed by aldesleukin and sargramostim works in treating patients with     inflammatory stage IIIB or metastatic stage IV breast cancer. Drugs used in chemotherapy,     such as busulfan, melphalan, and thiotepa, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell     transplant may be able to replace blood-forming cells that were destroyed by chemotherapy.     This may allow more chemotherapy to be given so that more tumor cells are killed. Aldesleukin     may stimulate the white blood cells to kill breast cancer cells. Giving aldesleukin together     with sargramostim may kill more tumor cells   "
163800|NCT00003200|"     The purpose of this research study is to develop a new chemo radiotherapy regimen for the     treatment of cancer of the head and neck for patients who have received induction     chemotherapy; and to determine the highest dose of Taxotere which can be safely given     together with radiotherapy.   "
163801|NCT00003202|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase I/II trial to compare the effectiveness of gemcitabine with radiation therapy     alone or following two-drug combination chemotherapy in treating patients with stage III     non-small cell lung cancer.   "
163802|NCT00003203|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and vincristine, work in different     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Combining carboplatin and vincristine with     radiation therapy followed by adjuvant chemotherapy may kill more tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy     plus radiation therapy followed adjuvant chemotherapy in treating young patients who have     newly diagnosed high-risk CNS embryonal tumors.   "
163803|NCT00003204|"     Randomized phase III trial to compare the effectiveness of two regimens of combination     chemotherapy followed by rituximab or observation in treating patients who have stage III or     stage IV low-grade non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to     stop cancer cells from dividing so they stop growing or die. Combining more than one drug may     kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.     It is not yet known which regimen of combination chemotherapy, with or without rituximab, is     more effective for non-Hodgkin's lymphoma   "
163804|NCT00003205|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with     stage IV breast cancer.   "
163805|NCT00003206|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating     patients with locally recurrent or metastatic nasopharyngeal cancer.   "
163806|NCT00003207|"     The rationale for conducting this study lies in the premise that if indeed the reason for a     limited response of Kaposi's sarcoma lesions and other advanced malignancies to chemotherapy     is attributable to a high expression of P-glycoprotein, then, by inhibiting this pump, tumor     kill would be enhanced and response rates as well as duration of responses would also     increase. Doxil is chosen since recent studies have shown that it is superior to combination     chemotherapy with ABV or BV. Doxil is also known to be active in other malignancies such as     breast and ovarian cancer (34,35). PSC 833 is chosen since it has been found to reverse P-gp     in vitro and in vivo, is non-immunosuppressive, and has been shown in recent Phase 1 studies     to be well tolerated.      There are yet no human studies reported on Doxil pharmacokinetics when combined with MDR     modulators. Preclinical data shows that pharmacokinetics of Doxil, unlike free doxorubicin,     is minimally affected by the addition of PSC 833 (36). Enhanced tumor toxicity was observed     when PSC 833 was combined with Doxil. Since doxorubicin, the active agent in Doxil, is     metabolized by the same cytochrome P450, interactions between these 2 agents may have very     significant clinical implications. The purpose of this study is to assess the toxicity and     determine the maximum tolerated dose of Doxil when combined with PSC 833 in the treatment of     AIDS-KS and other advanced malignancies.   "
163807|NCT00003209|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet     known whether giving radiation therapy with chemotherapy after surgery is more effective than     radiation therapy alone after surgery in treating cervical cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without chemotherapy after surgery in treating patients with stage IB or stage IIA cervical     cancer.   "
163809|NCT00003211|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy and radiation therapy with peripheral stem     cell transplantation may allow the doctor to give higher doses of chemotherapy or radiation     therapy and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy with topotecan,     cyclophosphamide, cisplatin, and vincristine plus radiation therapy and peripheral stem cell     transplantation in treating children with newly diagnosed medulloblastoma or supratentorial     primitive neuroectodermal tumor.   "
163810|NCT00003212|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether ifosfamide or doxorubicin is more     effective for advanced or metastatic soft tissue sarcoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with that of     doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma.   "
163811|NCT00003213|"     RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients     treated with chemotherapy. It is not known whether receiving dexamethasone with granisetron     is more effective than receiving dexamethasone with metoclopramide for reducing the side     effects of chemotherapy.      PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with either     granisetron or metoclopramide in patients treated with chemotherapy.   "
163812|NCT00003214|"     RATIONALE: Chemosensitizers may increase the effectiveness of a chemotherapy drug by making     tumor cells more sensitive to the drug.      PURPOSE: Randomized phase III trial to study the effectiveness of chemosensitivity testing to     assign treatment for patients with stage III or stage IV ovarian cancer who have undergone     surgery.   "
163813|NCT00003215|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining peripheral stem cell transplantation with more than one     drug regimen may kill more tumor cells. It is not known whether receiving standard     combination chemotherapy alone is more effective than receiving multiple combination     chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is comparing giving different combination     chemotherapy regimens together with peripheral stem cell transplantation to see how well they     work in treating patients with newly diagnosed aggressive non-Hodgkin's lymphoma.   "
163814|NCT00003216|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known     which treatment regimen is most effective for pancreatic cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and     gemcitabine plus radiation therapy in treating patients with cancer of the pancreas who have     undergone surgery.   "
163815|NCT00003217|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of     methotrexate and cyclophosphamide in treating children who have stage III or stage IV     non-Hodgkin's lymphoma or acute lymphoblastic leukemia.   "
163816|NCT00003219|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients     with metastatic breast cancer that has not responded to previous chemotherapy.   "
163817|NCT00003220|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with     metastatic colorectal cancer.   "
163818|NCT00003222|"     RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to     and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of     immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a     person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and     interleukin-2 may be kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with     or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV     melanoma.   "
163819|NCT00003223|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of fenretinide may be an effective way to     prevent the development of cancer in patients with neoplasia of the mouth.      PURPOSE: Phase II trial to study the effectiveness of fenretinide in preventing cancer in     patients who have neoplasia of the mouth.   "
163820|NCT00003224|"     RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill     tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with     either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma.      PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide     946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with     metastatic melanoma that cannot be surgically removed or with melanoma that is likely to     recur.   "
163821|NCT00003225|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus irinotecan in     treating patients with metastatic colorectal cancer.   "
163822|NCT00003229|"     RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the     body build an immune response and kill the tumor cells.      PURPOSE: Randomized phase I/II trial to study the effectiveness of vaccine therapy made from     white blood cells and melanoma cells in treating patients with metastatic melanoma who are     undergoing surgery for lymph node and tumor removal.   "
163823|NCT00003230|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel in treating patients with     refractory or recurrent acute leukemia or chronic myelogenous leukemia.   "
164726|NCT00005301|"     To evaluate factors influencing the risk of transfusion-transmitted human immunodeficiency     virus (HIV) infection and its progression to clinically significant manifestations.   "
163824|NCT00003231|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug with surgery may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with docetaxel     and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung     cancer.   "
163825|NCT00003232|"     RATIONALE: Some drugs used in chemotherapy can reduce the pain experienced by some people     with cancer. Combining more than one drug may be more effective at reducing cancer pain. It     is not known whether receiving combination chemotherapy with clodronate is more effective     than receiving combination chemotherapy without clodronate for hormone refractory metastatic     prostate cancer.      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of     combination chemotherapy using mitoxantrone plus prednisone with or without clodronate in     treating pain in patients with hormone refractory metastatic prostate cancer.   "
163826|NCT00003234|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with     recurrent or refractory cancer.   "
163827|NCT00003235|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug with either standard radiation therapy or radiation therapy     given at different times may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     consisting of paclitaxel and carboplatin, plus either standard radiation therapy or radiation     therapy given at different times, in treating patients with stage III non-small cell lung     cancer that cannot be surgically removed.   "
163828|NCT00003236|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase II trial to compare the effectiveness of ISIS 5132 with ISIS 3521     in treating women who have metastatic breast cancer that has not responded to previous     therapy.   "
163829|NCT00003237|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug, and giving them after surgery, may     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of     paclitaxel and cisplatin, given after surgery in treating patients with cancer of the     esophagus or stomach.   "
163830|NCT00003238|"     RATIONALE: Drugs used in chemotherapy use different way to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients     with metastatic prostate cancer that has not responded to hormone therapy with androgens.   "
163831|NCT00003239|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining biological therapy with chemotherapy may kill more     cancer cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy with cytarabine and     homoharringtonine and biological therapy with interferon alfa in treating patients with     chronic phase chronic myelogenous leukemia.   "
163832|NCT00003240|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not known whether giving chemotherapy in addition to standard     therapy is a more effective treatment for lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of standard therapy given     with or without combination chemotherapy in treating patients with non-small cell lung     cancer.   "
163833|NCT00003241|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of phenylacetate in treating children with     recurrent or progressive brain tumors.   "
163834|NCT00003242|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of chemotherapy with bryostatin 1 plus     paclitaxel and cisplatin in treating patients with advanced solid tumors.   "
163835|NCT00003243|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. White     blood cells from donors may be able to kill cancer cells in patients who have hematologic     cancer that has recurred following bone marrow transplantation.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus infusion     of donated white blood cells in treating patients who have hematologic cancer that has     recurred after bone marrow transplantation.   "
163836|NCT00003245|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with     recurrent or refractory non-Hodgkin's lymphoma.   "
163837|NCT00003248|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Combining     monoclonal antibody therapy with chemotherapy may kill more cancer cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine given with or     without monoclonal antibody therapy followed by monoclonal antibody therapy alone in treating     patients who have untreated B-cell chronic lymphocytic leukemia.   "
163838|NCT00003249|"     Phase I trial to study the effectiveness of carboxyamidotriazole and ketoconazole in treating     patients with advanced cancers. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die. Combining more than one drug may kill more     tumor cells.   "
163839|NCT00003250|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of fenretinide in treating patients who     have solid tumors.   "
163976|NCT00003910|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of methotrexate with or without     cyclophosphamide in treating patients who have lymphocytic leukemia with neutropenia or     anemia.   "
163840|NCT00003251|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as     amifostine, may protect normal cells from the side effects of chemotherapy and radiation     therapy.      PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus cisplatin,     paclitaxel, and radiation therapy in treating patients who have advanced unresectable head     and neck cancer.   "
163841|NCT00003252|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells     from the side effects of chemotherapy.      PURPOSE: Phase IV trial to study the effectiveness of amifostine in treating patients with     cancer who have neurological changes caused by chemotherapy.   "
163842|NCT00003253|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Some patients may develop a resistance to chemotherapy drugs.      PURPOSE: Phase II trial to determine the reliability of a test for measuring drug resistance     to paclitaxel in patients with metastatic breast cancer.   "
163843|NCT00003254|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Ethynyluracil may help fluorouracil kill more cancer cells by     making tumor cells more sensitive to the drug.      PURPOSE: Phase II trial to study the effectiveness of fluorouracil plus ethynyluracil in     treating patients with advanced colorectal cancer that has not responded to fluorouracil.   "
163844|NCT00003255|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining carboplatin and topotecan in     treating patients with relapsed acute myelogenous leukemia.   "
163845|NCT00003256|"     Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent     prostate cancer after hormone therapy. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die.   "
163846|NCT00003257|"     RATIONALE: Inserting the gene for p53 into a person's tumor may improve the body's ability to     fight cancer or make the cancer more sensitive to chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who     have recurrent head and neck cancer.   "
163847|NCT00003259|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients with     metastatic prostate cancer that has not responded to hormone therapy.   "
163848|NCT00003260|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving the drugs in different     combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with     fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil     and leucovorin in treating recurrent metastatic colorectal cancer      PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with     oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent     metastatic colorectal cancer.   "
163849|NCT00003261|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving methotrexate and zidovudine together     with radiation therapy works in treating patients with HIV-related primary central nervous     system lymphoma.   "
163850|NCT00003262|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens     in treating patients with Hodgkin's disease and HIV infection.   "
163851|NCT00003263|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy,     radiation therapy, and interferon alfa may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of cisplatin plus interferon alfa followed     by surgery and interferon alfa plus radiation therapy in treating patients with malignant     pleural mesothelioma.   "
163852|NCT00003264|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of cisplatin plus gemcitabine in treating     patients with advanced squamous cell head and neck cancer that cannot be treated by surgery     or radiation therapy.   "
163853|NCT00003266|"     RATIONALE: Methylphenidate may relieve some of the side effects of chemotherapy in patients     with melanoma. It is not known whether receiving methylphenidate is more effective than     receiving no further therapy in treating patients with melanoma.      PURPOSE: Randomized phase III trial to determine if methylphenidate is more effective than no     further therapy for the relief of fatigue and drowsiness in treating patients with melanoma     who have received high-dose interferon alfa for 8-24 weeks.   "
163854|NCT00003267|"     RATIONALE: The use of pelvic drains may help to prevent complications following radical     hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains     during surgery is more effective than receiving no pelvic drains during surgery in patients     with uterine, cervical, or vaginal cancer.      PURPOSE: Randomized phase III trial to determine if the use of pelvic drains following     radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with     uterine, cervical, or vaginal cancer.   "
163855|NCT00003268|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.     Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of     chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of amifostine in treating patients with     newly diagnosed acute myeloid leukemia who are receiving idarubicin plus cytarabine.   "
202961|NCT00497783|"     The purpose of this study is to demonstrate the safety of the gynecological formulation in     normal and usual usage condition of Dermacyd Femina Delicata.   "
163856|NCT00003269|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells     from the side effects of chemotherapy.      PURPOSE: Randomized phase II trial to study the effectiveness of amifostine followed by     high-dose chemotherapy in treating patients with hematologic cancer or solid tumors.   "
163857|NCT00003270|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Umbilical cord blood transplantation may allow doctors to give higher doses of     chemotherapy or radiation therapy and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and     umbilical cord blood transplantation in treating patients with hematologic cancer.   "
163858|NCT00003273|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of different regimens of combination     chemotherapy followed by peripheral stem cell transplantation in treating children who have     newly diagnosed brain tumor.   "
163859|NCT00003274|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not     yet known what preparation of vaccine therapy is most effective for treating melanoma.      PURPOSE: Randomized phase II trial to study the effectiveness of tyrosinase/gp100 peptide     vaccine in treating patients who have stage II melanoma that can be removed by surgery.   "
163860|NCT00003276|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with     advanced gallbladder or bile duct cancer that cannot be removed surgically.   "
163861|NCT00003278|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Combining     radiation therapy with a corticosteroid, such as dexamethasone, may be an effective treatment     for non-Hodgkin's lymphoma.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy and high-dose     dexamethasone in treating older patients with primary CNS non-Hodgkin's lymphoma.   "
163862|NCT00003279|"     RATIONALE: Vaccines may help the body build an immune response to kill tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of vaccination with     monoclonal antibody BEC2 and BCG with that of no further therapy in treating patients who     have limited-stage small cell lung cancer.   "
163863|NCT00003280|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. It is not yet     known which treatment regimen is more effective for lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of     rituximab in treating patients who have follicular or mantle cell lymphoma.   "
163864|NCT00003281|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating     patients who have recurrent or refractory small cell lung cancer.   "
163865|NCT00003282|"     Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may     help to plan effective treatment for solid tumors. This phase I trial is studying how well     EF5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors     that can be biopsied or removed by surgery   "
163866|NCT00003283|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to compare the effectiveness of octreotide alone or with prednisone     in treating patients with metastatic or recurrent thymoma.   "
163867|NCT00003284|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy     followed by peripheral stem cell transplantation in treating patients with lung cancer.   "
163868|NCT00003287|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which regimen of combination chemotherapy is more effective in treating patients     with recurrent or metastatic colorectal cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of combining fluorouracil,     leucovorin, and oxaliplatin in different ways in treating patients with recurrent or     metastatic colorectal cancer.   "
163869|NCT00003288|"     Phase I trial to study the effectiveness of tirapazamine plus cyclophosphamide in treating     children who have refractory solid tumors. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may     kill more tumor cells.   "
163870|NCT00003289|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of UCN-01 in treating patients with     advanced cancer that has not responded to previous treatment.   "
163871|NCT00003290|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known whether standard radiation therapy is more effective than high-dose radiation therapy     in treating patients with prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation     therapy with that of high-dose radiation therapy in treating patients with stage II or stage     III prostate cancer.   "
163872|NCT00003291|"     RATIONALE: The identification of gene mutations may allow doctors to better determine the     prognosis of children with acute lymphoblastic leukemia.      PURPOSE: This clinical trial is studying gene mutations to see if they are related to     prognosis of cancer in children with acute lymphoblastic leukemia.   "
163873|NCT00003292|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ifosfamide in treating patients with     meningeal tumors that have recurred or that cannot be removed surgically.   "
163874|NCT00003293|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether SU-101 is more effective than     procarbazine in treating patients with glioblastoma multiforme.      PURPOSE: Randomized phase III trial to compare the effectiveness of SU-101 with that of     procarbazine in treating patients with glioblastoma multiforme that has recurred.   "
163875|NCT00003294|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells     from the side effects of chemotherapy. Colony-stimulating factors such as filgrastim may     increase the number of immune cells found in bone marrow or peripheral blood and may help a     person's immune system recover from the side effects of chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of     paclitaxel plus carboplatin given with amifostine and filgrastim in treating patients with     recurrent or metastatic cancer.   "
163876|NCT00003296|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating     patients with liver or bile duct cancer.   "
163877|NCT00003297|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus     peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian     cancer that has not recurred or that has not responded to previous chemotherapy.   "
163878|NCT00003298|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells. E7296 was     conducted to study neoadjuvant chemotherapy and postoperative chemoradiation therapy in     patients diagnosed with high-risk gastric cancer using a new neoadjuvant regimen: paclitaxel     plus cisplatin. It was hypothesized that this new neoadjuvant chemotherapy followed by     surgery and chemoradiation therapy would be well tolerated and would have a high curative     resection rate.   "
163930|NCT00003361|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of decitabine in treating patients with     myelodysplastic syndrome.   "
163879|NCT00003299|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether cisplatin, etoposide, and paclitaxel are more effective than cisplatin and     etoposide alone in treating patients with extensive-stage small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide     with or without paclitaxel in treating patients with extensive-stage small cell lung cancer.   "
163880|NCT00003301|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of irinotecan in treating patients with     recurrent malignant glioma.   "
163881|NCT00003302|"     RATIONALE: New imaging procedures, such as MRI, may improve the ability to detect breast     tumors.      PURPOSE: Diagnostic study to determine the value of MRI in detecting breast tumors in women     who have had suspicious mammographic or clinical examinations.   "
163882|NCT00003304|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with     recurrent oligodendroglial tumors following combination chemotherapy.   "
163883|NCT00003305|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of aminopterin in treating patients who     have refractory leukemia.   "
163884|NCT00003307|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Amifostine may     protect normal cells from the side effects of radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus amifostine in     treating patients with primary prostate cancer.   "
163885|NCT00003308|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients     with newly diagnosed brain metastases from kidney cancer, melanoma, or sarcoma.   "
163886|NCT00003309|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug and combining chemotherapy with radiation therapy may kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     radiation therapy in treating adult patients with brain cancer.   "
163887|NCT00003311|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of different regimens of combination     chemotherapy in treating patients with newly diagnosed mantle cell lymphoma.   "
163888|NCT00003312|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation     therapy through seeds implanted into the prostate may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of brachytherapy in treating patients with     stage I or stage II prostate cancer.   "
163889|NCT00003313|"     RATIONALE: Amifostine may be an effective treatment for the toxic side effects caused by     radiation therapy and chemotherapy. It is not yet known whether chemotherapy and radiation     therapy are more effective with or without amifostine for non-small cell lung cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of amifostine in treating     patients who have stage II or stage III non-small cell lung cancer that cannot be surgically     removed and who are undergoing chemotherapy and radiation therapy.   "
163906|NCT00003334|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and paclitaxel in     treating patients who have recurrent or refractory endometrial cancer, fallopian tube cancer,     or sarcoma of the female reproductive tract.   "
163890|NCT00003315|"     RATIONALE: Drugs like liposomal amphotericin B may be able to relieve fungal infection which     can be a side effect of chemotherapy. Colony-stimulating factors such as sargramostim may     increase the number of immune cells found in bone marrow or peripheral blood and may help a     person's immune system recover from the side effects of chemotherapy. It is not yet known     whether receiving liposomal amphotericin B plus sargramostim is more effective than receiving     liposomal amphotericin B alone in treating patients with invasive fungal infection.      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of liposomal     amphotericin B with or without sargramostim in treating patients with invasive fungal     infection.   "
163891|NCT00003316|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with     recurrent or refractory cancer of the uterus.   "
163892|NCT00003317|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation     therapy uses high-energy x-rays to damage tumor cells. It is not yet known if combination     chemotherapy is more effective with or without radiation therapy for stage IIIA non-small     cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without radiation therapy in treating patients who have stage IIIA non-small cell     lung cancer that has been surgically removed.   "
163893|NCT00003320|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation     therapy after surgery to remove brain metastases may decrease the amount of radiation     required to treat brain metastases.      PURPOSE: Pilot trial to study the effectiveness of radiation therapy following surgery to     remove brain metastases.   "
163894|NCT00003321|"     RATIONALE: Questionnaires that measure quality of life may improve the ability to plan     treatment for patients who have cancer of the esophagus.      PURPOSE: This clinical trial studies quality-of-life assessments of patients with cancer of     the esophagus who are receiving treatment.   "
164858|NCT00005434|"     To confirm the preliminary findings of age, race, and hypertension chronicity effects on     opioid and cardiovascular responses to stress and to determine the opioid mechanisms     mediating these effects using an opioid receptor blockade strategy.   "
163895|NCT00003322|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving drugs in different ways may     kill more tumor cells. It is not yet known whether intravenous two-drug combination     chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug     combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous two-drug     combination chemotherapy with intravenous and intraperitoneal three-drug combination     chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian     cancer.   "
163896|NCT00003323|"     RATIONALE: Male hormones can stimulate the growth of prostate cancer cells. Hormone therapy     using flutamide and finasteride may fight prostate cancer by reducing the production of male     hormones.      PURPOSE: Phase II trial to study the effectiveness of flutamide and finasteride in treating     prostate cancer patients with high PSA levels who were previously treated with radiation     therapy or radical prostatectomy.   "
163897|NCT00003324|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells in a single high     dose. Combining radiation therapy with surgery may be a more effective treatment for brain     metastases.      PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without     surgery in treating patients who have brain metastases.   "
163898|NCT00003325|"     RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva.      PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating     patients with stage I or stage II cancer of the vulva.   "
163899|NCT00003326|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with     metastatic, recurrent, or unresectable cancer of the esophagus.   "
163900|NCT00003327|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with     recurrent or refractory head and neck cancer.   "
163901|NCT00003328|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether radiation therapy followed by porfiromycin is more effective     than radiation therapy alone in treating patients with head and neck cancer.      PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of     radiation therapy followed by porfiromycin in treating patients with stage III or stage IV     head and neck cancer.   "
163902|NCT00003329|"     RATIONALE: Identification of genes that may be associated with developing certain types of     cancer may someday provide important information about a person's risk of getting cancer.      PURPOSE: This clinical trial is studying to see if certain genes may be associated with     cancer in patients with cancer of the breast, prostate, lung, or colon and siblings of these     patients.   "
163903|NCT00003330|"     Phase I trial to study the effectiveness of interleukin-12 in treating patients who have     advanced cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and     by stimulating a person's white blood cells to kill cancer cells.   "
163904|NCT00003331|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining topotecan, fluorouracil, and     leucovorin in treating patients who have advanced cancer.   "
163905|NCT00003332|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug with radiation therapy and/or surgery     may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy, consisting     of gemcitabine and cisplatin, followed by chemotherapy and radiation therapy and/or surgery     in treating patients who have pancreatic cancer.   "
164007|NCT00004108|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have     liver cancer.   "
163907|NCT00003335|"     RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of     chemotherapy or radiation therapy and kill more cancer cells.      PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to     see how well it works when given with chemotherapy or radiation therapy in treating patients     with high-risk hematologic cancer.   "
163908|NCT00003336|"     RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of     chemotherapy or radiation therapy and kill more cancer cells.      PURPOSE: This phase II trial is studying how well umbilical cord blood transplantation works     in treating patients with severe aplastic anemia, malignant thymoma, or myelodysplasia.   "
163909|NCT00003337|"     RATIONALE: Diagnostic imaging procedures using radiolabeled monoclonal antibodies may improve     the ability to detect and stage non-Hodgkin's lymphoma.      PURPOSE: Phase III trial to study the effectiveness of a radiolabeled monoclonal antibody in     the detection and staging of patients with non-Hodgkin's lymphoma.   "
163910|NCT00003338|"     RATIONALE: Diagnostic imaging procedures, such as radiolabeled monoclonal antibodies, may     improve the ability to detect the residual disease in patients who have been treated for     non-Hodgkin's lymphoma.      PURPOSE: Phase II/III trial to study the effectiveness of monoclonal antibodies in detecting     residual disease in patients who have been treated for non-Hodgkin's lymphoma.   "
163911|NCT00003339|"     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune     response that will kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood     flow to the tumor and by stimulating white blood cells to kill melanoma cells.      PURPOSE: Randomized phase II trial to determine the effectiveness of vaccine therapy given     with interleukin-12 in treating patients who have stage III or stage IV melanoma.   "
163912|NCT00003340|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide plus topotecan in     treating patients who have refractory or relapsed acute myelogenous leukemia.   "
163913|NCT00003341|"     RATIONALE: Drugs such as epoetin alfa may relieve anemia caused by chemotherapy. The best     time for giving epoetin alfa during chemotherapy is not yet known.      PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating     anemia in patients with lymphoma, chronic lymphocytic leukemia, or multiple myeloma who are     receiving chemotherapy.   "
163914|NCT00003342|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects of giving gemcitabine, doxorubicin,     and paclitaxel together with carboplatin in treating patients with advanced bladder or kidney     cancer and impaired kidney function.   "
163915|NCT00003343|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether mitoxantrone and prednisone are more     effective with or without prinomastat in treating patients with metastatic prostate cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of mitoxantrone and     prednisone with or without prinomastat in treating patients who have metastatic prostate     cancer that has not responded to hormone therapy.   "
163916|NCT00003344|"     RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus irinotecan in     treating patients with colon cancer that is recurrent or that cannot be removed surgically.   "
163917|NCT00003345|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and irinotecan in     treating patients who have ovarian, fallopian tube, or peritoneal cancer.   "
163918|NCT00003346|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting     of acetaminophen plus carmustine in treating patients who have stage III or stage IV     melanoma.   "
163919|NCT00003348|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of carmustine plus O(6)-benzylguanine in     treating patients who have recurrent or progressive gliomas of the brain.   "
163920|NCT00003350|"     Randomized phase III trial to compare the effectiveness of paclitaxel with that of     doxorubicin in treating patients who have advanced AIDS-related Kaposi's sarcoma. Drugs used     in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether paclitaxel is more effective than doxorubicin in treating     patients with advanced AIDS-related Kaposi's sarcoma   "
163921|NCT00003351|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of irinotecan     in treating patients who have refractory metastatic breast cancer.   "
163922|NCT00003352|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of     doxorubicin, cyclophosphamide, and docetaxel in treating women with stage IIIB or stage IV     breast cancer.   "
163923|NCT00003353|"     RATIONALE: High-dose chemotherapy may destroy the amyloid-producing cells in bone marrow.     Peripheral stem cell transplantation      PURPOSE: Phase II trial to study the effectiveness of high dose melphalan plus peripheral     stem cell transplantation in treating patients who have primary systemic amyloidosis.   "
163973|NCT00003907|"     RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and     keeping chemotherapy drugs near the tumor.      PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients     who have primary liver cancer or metastases to the liver that cannot be surgically removed.   "
163924|NCT00003354|"     RATIONALE: Laparoscopic-assisted surgery is a less invasive type of surgery for colorectal     cancer and may have fewer side effects and improve recovery. It is not yet known if     undergoing conventional surgery is more effective than laparoscopic-assisted surgery for     colorectal cancer.      PURPOSE: This randomized phase III trial is studying conventional surgery to see how well it     works compared to laparoscopic-assisted surgery in treating patients with colorectal cancer.   "
163925|NCT00003356|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a     person's white blood cells to kill cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining rituximab and interleukin-2     intreating patients who have low-grade mantle cell lymphoma or follicular lymphoma.   "
163926|NCT00003357|"     RATIONALE: Vaccines made from GM2-KLH and given with QS21 may make the body build an immune     response to and kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of GM2-KLH vaccine plus QS21 in treating     patients with breast cancer who have no evidence of disease.   "
163927|NCT00003358|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of cisplatin plus gemcitabine in treating     patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary     peritoneal cancer.   "
163928|NCT00003359|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of T138067 sodium in treating patients with     advanced refractory cancer.   "
163929|NCT00003360|"     RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances,     such as radioactive iodine, to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in     treating patients with advanced colorectal cancer.   "
163931|NCT00003362|"     RATIONALE: Vaccines made from peptides that are found on melanoma cells may make the body     build an immune response and kill melanoma cells. Combining vaccine therapy with immune     adjuvants, such as GM-CSF, Montanide ISA-51, or QS21, may be a more effective treatment for     advanced melanoma.      PURPOSE: Randomized phase II trial to study the effectiveness of gp 100-tyrosinase peptide     vaccine with one of the immune adjuvants GM-CSF, Montanide ISA-51, or QS21 in treating     patients who have stage III or stage IV melanoma.   "
163932|NCT00003364|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than one drug with radiation therapy may kill more tumor cells. The best     timing for radiation therapy and combination chemotherapy in treating limited stage small     cell lung cancer is not yet known .      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy given     at different times along with combination chemotherapy in treating patients with limited     stage small cell lung cancer.   "
163933|NCT00003365|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of sulindac may be an effective way to prevent     colon cancer. Eating a diet rich in fruits and vegetables appears to reduce the risk of some     types of cancer. Curcumin, rutin, and quercetin are compounds found in plants that may     prevent the development of colon cancer.      PURPOSE: Randomized clinical trial to study the effectiveness of sulindac, curcumin, rutin,     and quercetin in preventing colon cancer.   "
163934|NCT00003367|"     RATIONALE: The amount of fat, fiber, soy, fruits, vegetables, vitamin E, and green tea in the     diet may affect androgen metabolism in men. This may affect PSA level in patients with     prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two diets, differing in     fat, fiber, soy, fruit, vegetable, vitamin E, and green tea content, in affecting PSA level     in patients with prostate cancer.   "
163935|NCT00003368|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Irinotecan may be effective in treating patients with abnormal     liver or kidney function or who have received radiation therapy.      PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating patients with     solid tumors or lymphoma who have abnormal liver or kidney function or who have had previous     radiation therapy to the pelvis.   "
163936|NCT00003369|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of     tirapazamine plus cisplatin in treating patients who have metastatic, recurrent, or     refractory cervical cancer.   "
163937|NCT00003370|"     Phase I trial to study the effectiveness of irofulven in treating children with recurrent or     refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells so     they stop growing or die.   "
163938|NCT00003372|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with     recurrent brain tumor.   "
163939|NCT00003375|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether radiation therapy combined with chemotherapy is more     effective than radiation therapy alone in treating patients with low-grade glioma.      PURPOSE: Phase II/III trial to evaluate observation and to compare the effectiveness of     radiation therapy with or without combination chemotherapy in treating patients with     low-grade glioma.   "
163974|NCT00003908|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating     patients who have metastatic or recurrent head and neck cancer.   "
163940|NCT00003376|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known if four-drug combination chemotherapy is more effective than two-drug combination     chemotherapy in treating advanced cancer of the urothelium.      PURPOSE: Randomized phase III trial to compare the effectiveness of four-drug combination     chemotherapy with that of two-drug combination chemotherapy in treating patients who have     advanced cancer of the urothelium.   "
163941|NCT00003377|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and     cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more     sensitive to the radiation. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may     kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel when     given with radiation therapy and cisplatin and to see how well they work in treating patients     with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen.   "
163942|NCT00003378|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating     patients with previously untreated stage III or stage IV ovarian or primary peritoneal     cancer.   "
163943|NCT00003379|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and     cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more     sensitive to radiation. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may     kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy to the pelvis plus     paclitaxel and cisplatin in treating patients who have cervical cancer.   "
163944|NCT00003380|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of     liposomal doxorubicin and etoposide in treating patients who have recurrent or persistent     ovarian, fallopian tube, or peritoneal cancer.   "
163945|NCT00003381|"     RATIONALE: Questionnaires that measure quality of life during treatment may improve the     ability to plan treatment for patients with esophageal cancer.      PURPOSE: This clinical trial is studying the quality of life in patients receiving treatment     for esophageal cancer.   "
163946|NCT00003382|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of     gemcitabine and topotecan in treating patients with refractory or recurrent ovarian or     fallopian tube cancer.   "
163947|NCT00003384|"     This diagnostic trial is studying the presence of a specific protein as a potential biomarker     of cervical dysplasia and/or cancer. The presence of specific proteins may allow a doctor to     determine whether a patient has cervical dysplasia and/or cancer.   "
163948|NCT00003385|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of     liposomal doxorubicin, paclitaxel, and carboplatin in treating patients who have untreated     ovarian, peritoneal, or fallopian tube cancer.   "
163949|NCT00003386|"     RATIONALE: Vaccines made from tumor tissue may make the body build an immune response and     kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients     who have stage III or stage IV ovarian epithelial cancer.   "
163950|NCT00003387|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It     is not yet known whether giving chemotherapy before combined chemotherapy and radiation     therapy is more effective than combined chemotherapy and radiation therapy alone in treating     patients with non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin and     paclitaxel followed by radiation therapy and chemotherapy with radiation therapy and     chemotherapy alone in treating patients with stage III non-small cell lung cancer that cannot     be removed during surgery.   "
163951|NCT00003388|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of     liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in treating patients     with AIDS-related lymphoma.   "
163952|NCT00003389|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is     not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's     lymphoma.      PURPOSE: This randomized phase III trial is studying two different combination chemotherapy     regimens and comparing how well they work, with or without radiation therapy, in treating     patients with Hodgkin's lymphoma.   "
163953|NCT00003390|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating     patients with metastatic kidney cancer.   "
163954|NCT00003391|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of muJ591 monoclonal antibody in treating     patients who have metastatic prostate cancer that has not responded to hormone therapy.   "
163975|NCT00003909|"     Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin     gadolinium may make the tumor cells more sensitive to radiation therapy. Phase I trial to     study the effectiveness of motexafin gadolinium plus radiation therapy in treating children     who have newly diagnosed brain stem glioma   "
163955|NCT00003392|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose chemotherapy and peripheral     stem cell transplantation in treating patients with recurrent or refractory metastatic breast     cancer.   "
163956|NCT00003394|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting     of estramustine, paclitaxel, and carboplatin in treating patients with advanced prostate     cancer.   "
163957|NCT00003395|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients     who have advanced hematologic cancer.   "
163958|NCT00003396|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy used to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation     from related donors to prevent graft-versus-host disease in treating patients with     hematologic cancer.   "
163959|NCT00003891|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of lurtotecan liposome in treating patients     who have advanced solid tumors.   "
163960|NCT00003892|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ISIS 5132 in treating patients who have     metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy.   "
163995|NCT00004095|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining irinotecan and gemcitabine in     treating patients who have unresectable or metastatic solid tumors.   "
163961|NCT00003893|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     tumors cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is     not yet known which regimen of chemotherapy plus radiation therapy is more effective for     early-stage breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of     adjuvant chemotherapy plus radiation therapy in treating women who have early-stage breast     cancer.   "
163962|NCT00003894|"     RATIONALE: Thalidomide may interfere with the body's ability to recognize transplanted bone     marrow cells as foreign and may help treat patients with graft-versus-host disease.      PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating     patients who have chronic graft-versus-host disease following bone marrow transplantation.   "
163963|NCT00003895|"     This randomized pilot phase II trial studies how well vaccine therapy works in treating human     leukocyte antigen class 1 histocompatibility, A-2 (HLA-A2) positive patients with melanoma.     Vaccines made from peptides may help the body build an effective immune response to kill     tumor cells.   "
163964|NCT00003896|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and     liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian     cancer, fallopian tube cancer, or primary peritoneal cancer.   "
163965|NCT00003897|"     RATIONALE: Vaccines made from gp100 and sargramostim may make the body build an immune     response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy with gp100 and/or     sargramostim in treating patients who have malignant melanoma.   "
163966|NCT00003898|"     RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system     in children who are undergoing stem cell transplantation.      PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in     reducing inflammation of the mouth and digestive system in children who are undergoing     peripheral stem cell transplantation.   "
163967|NCT00003899|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase I trial to study the effectiveness of melphalan and thiotepa plus bone marrow     or peripheral stem cell transplantation in treating patients who have recurrent or refractory     solid tumors.   "
163968|NCT00003900|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and docetaxel in     treating patients who have recurrent or metastatic non-small cell lung cancer.   "
163969|NCT00003901|"     RATIONALE: Prognostic testing for early signs of metastases may help doctors detect     metastases early and plan more effective treatment.      PURPOSE: Phase III trial to study the relationship between early signs of metastases and     survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that     can be removed by surgery.   "
163970|NCT00003902|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine and     vinorelbine and to see how well they work in treating older women with metastatic breast     cancer with or without bone involvement.   "
163971|NCT00003903|"     RATIONALE: Assessing the effect of androgen suppression on bone loss in prostate cancer     patients may improve the ability to plan treatment, may decrease the risk of fractures and     bony pain, and may help patients live more comfortably.      PURPOSE: Clinical trial to determine the effect of androgen suppression on bone loss in     patients who have prostate cancer.   "
163972|NCT00003906|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the     tumor cells.      PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene     with that of tamoxifen in preventing breast cancer in postmenopausal women.   "
163977|NCT00003911|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic     radiosurgery may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by     stereotactic radiosurgery in treating patients who have brain metastases from malignant     melanoma.   "
163978|NCT00003912|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which chemotherapy regimen is more effective in     treating children with liver cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of cisplatin with or without     doxorubicin and the effectiveness of combining cisplatin, carboplatin, and doxorubicin in     treating children who have liver cancer.   "
163979|NCT00003913|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Umbilical cord blood transplantation may be able to replace     immune cells that were destroyed by the chemotherapy or radiation therapy that was used to     kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation     plus combination chemotherapy in treating patients who have hematologic cancer or     nonmalignant hematologic disease.   "
163980|NCT00003914|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with     advanced kidney cancer.   "
163981|NCT00003915|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Androgens can stimulate the growth of prostate cancer cells.     Hormone therapy using bicalutamide and leuprolide may fight prostate cancer by reducing the     production of androgens.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy consisting of docetaxel     and estramustine plus hormone therapy in treating patients who have previously undergone     radiation therapy or surgical removal of the prostate for stage I prostate cancer.   "
163982|NCT00003916|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an     effective treatment for patients with glioma. Stereotactic radiation therapy may be able to     deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet     known if standard radiation therapy is more effective when followed by stereotactic radiation     therapy.      PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation     therapy with or without stereotactic radiation therapy in treating patients who have glioma.   "
163983|NCT00003917|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if topotecan is more effective given by     infusion or by mouth.      PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by     infusion with that of topotecan given by mouth in treating patients who have small cell lung     cancer that has relapsed following previous therapy.   "
163984|NCT00003920|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver     tumor-killing substances to them without harming normal cells. Peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells. Sometimes the transplanted cells can make an immune response against the body's     normal tissues. Cyclosporine may prevent this from happening.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus     cyclosporine and peripheral stem cell transplantation in treating patients who have     metastatic breast cancer that has not responded to previous therapy.   "
163985|NCT00004085|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver     tumor-killing substances to them. Peripheral stem cell transplantation may be able to replace     immune cells that were destroyed by radioimmunotherapy used to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody     therapy plus peripheral stem cell transplantation in treating patients who have stage IV     breast cancer.   "
163986|NCT00004086|"     RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and either kill them or     deliver cancer killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to     give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus     combination chemotherapy and peripheral stem cell transplantation in treating patients who     have recurrent or B-cell cancer.   "
163987|NCT00004087|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver     tumor-killing substances to them without harming normal cells. Peripheral stem cell     transplantation may be able to replace immune cells that were destroyed by monoclonal     antibody therapy used to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus     peripheral stem cell transplantation in treating patients who have metastatic or recurrent     colorectal cancer or pancreatic cancer that has not responded to previous treatment.   "
163988|NCT00004088|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from     dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors     to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies,     such as interferon alfa, use different ways to stimulate the immune system and stop cancer     cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to     the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma.      PURPOSE: This phase II trial is studying combination chemotherapy, peripheral stem cell     transplantation, biological therapy, pamidronate, and thalidomide to see how well they work     in treating patients with stage I, stage II, or stage III multiple myeloma.   "
163989|NCT00004089|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation     therapy in treating patients who have previously untreated anaplastic thyroid cancer.   "
164727|NCT00005302|"     To determine the role of drugs in the etiology of aplastic anemia, agranulocytosis, and     thrombocytopenic purpura. Drugs used in chemotherapy and immunotherapy were excluded.   "
163990|NCT00004090|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of gemcitabine and cisplatin in treating     patients who have metastatic or recurrent solid tumors.   "
163991|NCT00004091|"     RATIONALE: Examining biomarkers in abnormal cervical cells may improve the ability to detect     these cells and plan effective treatment.      PURPOSE: Diagnostic trial to detect specific biomarkers in abnormal cervical cells in women     who have abnormal Pap test results.   "
163992|NCT00004092|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying two different regimens of combination     chemotherapy and comparing them to see how well they work in treating patients with high-risk     primary stage II or stage III breast cancer.   "
163993|NCT00004093|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy and radiation therapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus     radiation therapy in treating patients who have stage III non-small cell lung cancer.   "
163994|NCT00004094|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation     therapy in treating patients who have previously untreated advanced cancer of the mouth,     pharynx, or larynx.   "
164859|NCT00005435|"     To determine the combined effects of hostility, harassment, lipids, and oral contraceptive     (0C) use on physiological responses in young and middle-aged premenopausal women.   "
163996|NCT00004096|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining carboplatin and vinorelbine     in treating patients who have stage IIIB or stage IV non-small cell lung cancer.   "
163997|NCT00004097|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation     therapy in treating patients who have advanced and/or recurrent head and neck cancer.   "
163998|NCT00004099|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if surgery alone or surgery combined with     chemotherapy is more effective in treating stomach cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without     combination chemotherapy in treating patients who have stage II, stage III, or stage IV     stomach cancer.   "
163999|NCT00004100|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which regimen of chemotherapy is more effective     for non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of     chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.   "
164000|NCT00004101|"     Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients     who have recurrent non-Hodgkin's lymphoma. Monoclonal antibodies can locate cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.   "
164001|NCT00004102|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Leucovorin     may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the     drug.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of     oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.   "
164002|NCT00004103|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and combining chemotherapy with     surgery may kill more tumor cells.      PURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by     surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.   "
164003|NCT00004104|"     RATIONALE: Vaccines may make the body build an immune response and kill tumor cells.     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Interferon     alfa-2b may interfere with the growth of tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus     interleukin-2 with or without interferon alfa-2b in treating patients who have stage III     melanoma.   "
164004|NCT00004105|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of vinorelbine, paclitaxel, and     estramustine in treating patients who have advanced cancer that has not responded to previous     treatment.   "
164005|NCT00004106|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: This phase II trial is studying temozolomide to see how well it works in treating     patients with mycosis fungoides or Sezary syndrome that has not responded to previous     treatment.   "
164006|NCT00004107|"     RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and deliver     cancer-killing substances to them without harming normal cells. Peripheral stem cell     transplantation may be able to replace immune cells that were destroyed by monoclonal     antibody therapy used to kill cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody     therapy plus peripheral stem cell transplantation in treating patients who have lymphoma or     Waldenstrom's macroglobulinemia that has not responded to previous therapy.   "
164008|NCT00004109|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation     therapy in treating patients who have soft tissue sarcoma.   "
164009|NCT00004110|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor     killing substances to them without harming normal cells. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     monoclonal antibody therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus     etoposide in treating patients who have neuroblastoma.   "
164010|NCT00004112|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer     cells and either kill them or deliver cancer-killing substances to them without harming     normal cells. It is not yet known whether combination chemotherapy plus rituximab is more     effective than combination chemotherapy alone for non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without rituximab in treating patients who have newly diagnosed non-Hodgkin's     lymphoma that has not been treated previously.   "
164011|NCT00004113|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who     have recurrent malignant glioma.   "
164012|NCT00004114|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may be able to replace     immune cells that were destroyed by chemotherapy used to kill cancer cells.      PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell     transplantation in treating patients who have advanced hematologic cancer.   "
164013|NCT00004115|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. It is not yet known whether     monoclonal antibody therapy is more effective than observation for ovarian cancer or primary     peritoneal cancer that is in remission.      PURPOSE: Randomized phase III trial to compare the effectiveness of monoclonal antibody     therapy with that of observation in treating patients who have ovarian cancer or primary     peritoneal cancer in remission following surgery and chemotherapy.   "
164014|NCT00004122|"     RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system     and stop cancer cells from growing. Interferon alfa may interfere with the growth of cancer     cells. Combining these therapies may be an effective treatment for bladder cancer.      PURPOSE: Phase II trial to study the effectiveness of BCG plus interferon alfa 2b in treating     patients who have bladder cancer.   "
164015|NCT00004123|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus doxorubicin in     treating patients who have resectable primary or recurrent peritoneal soft tissue sarcoma.   "
164016|NCT00004124|"     RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy     may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy     use different ways to stop tumor cells from dividing so they stop growing or die. It is not     yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than     hormone therapy alone for prostate cancer.      PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and     prednisone to see how well they work compared to hormone therapy alone in treating patients     who have undergone radical prostatectomy for prostate cancer.   "
164017|NCT00004125|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which regimen of chemotherapy is more effective     for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of     combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that     has spread to the lymph nodes.   "
164018|NCT00004126|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and oxaliplatin in     treating patients who have recurrent or advanced non-small cell lung cancer.   "
164019|NCT00004127|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with fluorouracil     and leucovorin in treating patients who have recurrent or metastatic cancer of the esophagus     or stomach.   "
164020|NCT00004128|"     RATIONALE: Giving combination chemotherapy before a peripheral blood stem cell transplant     stops the growth of cancer cells by stopping them from dividing or killing them. After     treatment, stem cells are collected from the patient's blood or bone marrow and stored. More     chemotherapy or radiation therapy is given prepare the bone marrow for the stem cell     transplant. The stem cells are then returned to the patient to replace the blood-forming     cells that were destroyed by the chemotherapy and radiation therapy. Interleukin-2 may     stimulate the patient's white blood cells to kill cancer cells.      PURPOSE: This randomized phase III trial is studying two different regimens of combination     chemotherapy, interleukin-2, and peripheral stem cell transplant and comparing them to see     how well they work in treating patients with acute myeloid leukemia.   "
164021|NCT00004129|"     RATIONALE: Radioactive drugs such as phosphorus 32 may be able to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of phosphorus 32 in     treating patients with glioblastoma multiforme.   "
164038|NCT00004151|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of acridine carboxamide in treating     patients who have advanced non-small cell lung cancer that cannot be treated with surgery.   "
164022|NCT00004132|"     RATIONALE: Keratinocyte growth factor may prevent symptoms of mucositis in patients receiving     radiation therapy and chemotherapy.      PURPOSE: Randomized phase II trial to study the effectiveness of keratinocyte growth factor     in preventing oral mucositis in patients who have hematologic cancers and who are undergoing     radiation therapy and chemotherapy before autologous peripheral stem cell transplantation.   "
164023|NCT00004135|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune     cells that were destroyed by chemotherapy used to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell     transplantation in treating patients who have metastatic kidney cancer or melanoma.   "
164024|NCT00004136|"     RATIONALE: Heating tumors to several degrees above body temperature may kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of heat therapy in treating patients who     have unresectable primary or metastatic liver cancer.   "
164025|NCT00004137|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.     Colony-stimulating factors such as filgrastim may increase the number of immune cells found     in bone marrow or peripheral blood and may help a person's immune system recover from the     side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     filgrastim in treating patients who have previously untreated extensive-stage small cell lung     cancer.   "
164026|NCT00004138|"     RATIONALE: Imaging procedures, such as positron emission tomography (PET), may improve the     ability to detect the extent of non-small cell lung cancer.      PURPOSE: Diagnostic trial to study the effectiveness of PET for detecting lesions in patients     who have newly diagnosed stage I, stage II, or stage IIIA non-small cell lung cancer.   "
164860|NCT00005436|"     To study longitudinally the incidence, pathogenesis, and risk factors for thrombotic events     and coronary artery disease in a cohort of patients with systemic lupus erythematosus (SLE).   "
164027|NCT00004139|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to compare the effectiveness of gemcitabine plus either docetaxel or     irinotecan in treating patients who have stage IIIB or stage IV non-small cell lung cancer.   "
164028|NCT00004141|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Biological therapies use different ways to stimulate the immune     system and stop cancer cell from growing. Combining more than one drug with different types     of biological therapies may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     biological therapy in treating patients who have metastatic melanoma.   "
164029|NCT00004142|"     RATIONALE: Radiofrequency ablation may be able to shrink or destroy cancer cells. Drugs used     in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Chemotherapy delivered directly into the blood vessels of the liver may prevent new     tumors from growing. Combining these therapies may be an effective treatment for colorectal     cancer that has spread to the liver.      PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation followed by     chemotherapy delivered directly into the blood vessels of the liver in treating patients who     have colorectal cancer that has spread to the liver.   "
164030|NCT00004143|"     RATIONALE: Although used primarily to treat malignant disorders of the blood, allogeneic stem     cell transplantation can also cure a variety of non-cancerous, inherited or acquired     disorders of the blood. Unfortunately, the conventional approach to allogeneic stem cell     transplantation is a risky procedure. For some non-cancerous conditions, the risks of this     procedure outweigh the potential benefits. This protocol is designed to test a new approach     to allogeneic stem cell transplantation. It is hoped that this approach will be better suited     for patients with non-cancerous blood and bone marrow disorders.   "
164031|NCT00004144|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in     treating patients who have advanced cancer that has not responded to previous treatment.   "
164032|NCT00004145|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.     Sometimes the transplanted cells are rejected by the body's normal tissues. Antithymocyte     globulin may prevent this from happening.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus biological therapy     followed by peripheral stem cell transplantation in treating patients who have hematologic     cancer.   "
164033|NCT00004146|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining     radiation therapy with chemotherapy may kill more tumor cells. Phase II trial to study the     effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have     newly diagnosed supratentorial glioblastoma multiforme.   "
164034|NCT00004147|"     RATIONALE: COL-3 may stop the growth of brain tumors by stopping blood flow to the tumor.      PURPOSE: Phase I/II trial to study the effectiveness of COL-3 in treating patients who have     progressive or recurrent brain tumors following radiation therapy or chemotherapy.   "
164035|NCT00004148|"     Phase I trial to study the effectiveness of vaccine therapy in treating patients who have     unresectable metastatic melanoma. Vaccines may make the body build an immune response to kill     tumor cells.   "
164036|NCT00004149|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have stage IV prostate cancer that has not responded to hormone therapy.   "
164037|NCT00004150|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which chemotherapy regimen is more effective     for colon cancer.      PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without     leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in     treating patients who have undergone surgery for stage III colon cancer.   "
164039|NCT00004152|"     RATIONALE: Diagnostic procedures may improve the ability to detect metastatic melanoma and to     determine the extent of disease.      PURPOSE: Phase II trial to evaluate the effectiveness of PET and CT scans to detect     metastatic disease in patients who have stage III or stage IV melanoma.   "
164040|NCT00004153|"     RATIONALE: Diagnostic procedures may improve the ability to detect the presence or recurrence     of disease.      PURPOSE: Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood     of patients who have melanoma.   "
164041|NCT00004154|"     RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing. It     is not yet known whether fenretinide is more effective than a placebo in preventing the     recurrence of bladder cancer after surgery to remove the tumor.      PURPOSE: This randomized phase III trial is studying fenretinide to see how well it works     compared to a placebo in treating patients who are at risk for recurrent bladder cancer     following surgery to remove the tumor.   "
164042|NCT00004156|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.   "
164043|NCT00004157|"     RATIONALE: Interleukin-11 and filgrastim stimulate the production of blood cells. Giving     these drugs to stimulate peripheral stem cells that can be collected for peripheral stem cell     transplantation may result in fewer side effects after transplant.      PURPOSE: Phase II trial to study the effectiveness of interleukin-11 plus filgrastim prior to     peripheral stem cell transplantation in patients who have non-Hodgkin's lymphoma, Hodgkin's     disease, breast cancer, or other solid tumors.   "
164058|NCT00004175|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel, doxorubicin, and     cyclophosphamide in treating women who have previously untreated stage III breast cancer.   "
164044|NCT00004158|"     RATIONALE: Radiation therapy using holmium Ho 166 DOTMP may damage cancer cells. Drugs used     in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy used to kill cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy using holmium Ho     166 DOTMP plus melphalan and peripheral stem cell transplantation in treating patients who     have multiple myeloma.   "
164045|NCT00004159|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of gemcitabine plus paclitaxel in     treating patients who have advanced non-small cell lung cancer or other solid tumor.   "
164046|NCT00004160|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy plus radiation therapy     in treating patients who have stage III non-small cell lung cancer that cannot be surgically     removed.   "
164047|NCT00004161|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of or treat early cancer. Fenretinide may be an effective drug in treating     leukoplakia.      PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide in treating     patients who have leukoplakia of the mouth.   "
164048|NCT00004162|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of liposomal doxorubicin plus combination     chemotherapy in treating patients who have AIDS-associated non-Hodgkin's lymphoma.   "
164049|NCT00004163|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who     have advanced salivary gland cancer.   "
164050|NCT00004164|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have stage IIB, stage III, or stage IV cancer of the nasopharynx.   "
164051|NCT00004165|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to     give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase III trial to study the effectiveness of melphalan followed by peripheral stem     cell transplantation in treating patients who have multiple myeloma.   "
164052|NCT00004166|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells     from the side effects of chemotherapy.      PURPOSE: Randomized phase III trial to study the effectiveness of amifostine in treating     patients who have ovarian epithelial cancer and who are receiving chemotherapy.   "
164053|NCT00004169|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor     to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and     peripheral stem cell transplantation in treating patients who have recurrent or refractory     Hodgkin's disease.   "
164054|NCT00004171|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to     give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral     stem cell transplantation in treating patients who have Hodgkin's disease or non-Hodgkin's     lymphoma.   "
164071|NCT00004189|"     Phase I trial to study the effectiveness of rebeccamycin analog and cisplatin with or without     filgrastim in treating patients who have advanced cancer. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining more     than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may     increase the number of immune cells found in bone marrow or peripheral blood and may help a     person's immune system recover from the side effects of chemotherapy.   "
164055|NCT00004172|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy. Combining chemotherapy with     autologous peripheral stem cell transplantation may allow the doctor to give higher doses of     chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to     damage tumor cells.      PURPOSE: Phase II trial to compare the effectiveness of two regimens of chemotherapy and     filgrastim plus stem cell transplantation in treating patients who have previously untreated     stage III or stage IV breast cancer.   "
164056|NCT00004173|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and paclitaxel in treating     patients who have metastatic or unresectable cancer.   "
164057|NCT00004174|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by     peripheral stem cell transplantation in treating patients who have stage III or stage IV     breast cancer.   "
182661|NCT00233597|"     The study will evaluate the safety and efficacy of a new intravenously administered iron drug     to treat anemia in patients on hemodialysis.   "
164059|NCT00004176|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and     radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of amifostine plus chemotherapy and     radiation therapy in treating patients who have limited-stage small cell lung cancer.   "
164060|NCT00004177|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell     transplantation may be able to replace immune cells that were destroyed by therapy used to     kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus     peripheral stem cell transplantation in treating patients who have refractory or recurrent     ovarian epithelial cancer.   "
164061|NCT00004178|"     RATIONALE: Inserting a gene that has been created in the laboratory into a person's white     blood cells may make the body build an immune response to kill cancer cells.      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who     have cancer that has not responded to previous therapy.   "
164062|NCT00004179|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells     and either kill them or deliver cancer-killing substances to them without harming normal     cells. It is not yet known whether chemotherapy is more effective with or without rituximab     for relapsed non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab     to see how well they work compared to combination chemotherapy alone in treating patients     with relapsed non-Hodgkin's lymphoma.   "
164063|NCT00004180|"     RATIONALE: Rosiglitazone may help liposarcoma cells develop into normal fat cells.      PURPOSE: Phase II trial to study the effectiveness of rosiglitazone in treating patients who     have liposarcoma.   "
164064|NCT00004181|"     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were     destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation     in treating patients who have multiple myeloma, chronic phase chronic myelogenous leukemia,     or agnogenic myeloid metaplasia.   "
164065|NCT00004182|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who     have metastatic or recurrent breast cancer.   "
164066|NCT00004183|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who     have malignant mesothelioma.   "
164067|NCT00004184|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in     treating patients who have stage III or stage IV melanoma at high risk for recurrence     following surgery to remove the tumor.   "
164068|NCT00004186|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating     patients who have small cell lung cancer.   "
164069|NCT00004187|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine and     oxaliplatin in treating patients who have advanced or metastatic colorectal cancer that     cannot be surgically removed.   "
164070|NCT00004188|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation     with treated peripheral stem cells following combination chemotherapy to see how well it     works compared to peripheral stem cell transplantation with untreated peripheral stem cells     following combination chemotherapy in treating patients with neuroblastoma.   "
164072|NCT00004190|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and oxaliplatin     in treating patients who have refractory locally advanced or metastatic pancreatic cancer.   "
164073|NCT00004192|"     RATIONALE: Colony-stimulating factors may increase the number of immune cells found in bone     marrow or peripheral blood and may help a person's immune system recover from the side     effects of chemotherapy.      PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim-SD/01 with that     of filgrastim to relieve the neutropenia following combination chemotherapy in patients who     have non-Hodgkin's lymphoma.   "
164074|NCT00004193|"     RATIONALE: ISIS 2503 may kill cancer cells by inhibiting a gene that promotes the development     and growth of cancer.      PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have     metastatic and/or locally recurrent colorectal cancer.   "
164075|NCT00004194|"     RATIONALE: Fludarabine may be an effective treatment for graft-versus-host disease caused by     bone marrow transplantation.      PURPOSE: Phase I/II trial to study the effectiveness of fludarabine in treating patients who     have chronic graft-versus-host disease that has not responded to steroid therapy.   "
164076|NCT00004195|"     RATIONALE: Eniluracil may increase the effectiveness of chemotherapy by blocking tumor     enzymes that break down chemotherapy drugs.      PURPOSE: Randomized phase II trial to determine the effectiveness of eniluracil followed by     surgery in treating patients who have primary or metastatic colorectal cancer.   "
164077|NCT00004196|"     RATIONALE: Interferon alfa-2b may interfere with the growth of cancer cells.      PURPOSE: Randomized phase III trial to study the effectiveness of interferon alfa-2b in     treating patients who have melanoma with early lymph node metastasis.   "
164078|NCT00004197|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Vaccines may make the body build an immune response to kill     cancer cells. Colony-stimulating factors such as sargramostim may increase the number of     immune cells found in bone marrow or peripheral blood and may help a person's immune system     recover from the side effects of chemotherapy.      PURPOSE: Phase II trial of vaccine therapy plus sargramostim following chemotherapy in     treating patients who have previously untreated aggressive non-Hodgkin's lymphoma.   "
164079|NCT00004198|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Vaccines may make the body build an immune response to kill tumor     cells. Sargramostim may stimulate a person's immune system and help to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus sargramostim     following chemotherapy in treating patients who have stage III or stage IV non-Hodgkin's     lymphoma.   "
164080|NCT00004199|"     RATIONALE: Prinomastat may stop the growth of non-small cell lung cancer by stopping blood     flow to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop     growing or die.      PURPOSE: Randomized phase III trial to determine the effectiveness of prinomastat plus     cisplatin and gemcitabine in treating patients who have metastatic or recurrent non-small     cell lung cancer.   "
164081|NCT00004200|"     RATIONALE: Prinomastat may stop the growth of glioblastoma multiforme by stopping blood flow     to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop growing     or die.      PURPOSE: Randomized phase II trial to study the effectiveness of prinomastat plus     temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.   "
164082|NCT00004201|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine plus     carboplatin with that of gemcitabine plus cisplatin in treating patients who have stage IIIB,     stage IV, or recurrent non-small cell lung cancer.   "
164083|NCT00004202|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation     therapy, and RSR13 in treating patients who have stage III non-small cell lung cancer that     cannot be removed by surgery.   "
164084|NCT00004203|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who     have metastatic bladder cancer.   "
164085|NCT00004204|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who     have recurrent or progressive malignant glioma.   "
164086|NCT00004205|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by reducing the production of estrogen. Hormone therapy     using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor     cells. If is not yet known which treatment regimen is most effective for breast cancer.      PURPOSE: Randomized double-blind phase III trial to compare the effectiveness of letrozole     with that of tamoxifen in treating postmenopausal women who have breast cancer that has been     surgically removed.   "
164087|NCT00004206|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin and fluorouracil     in treating patients who have recurrent ovarian cancer.   "
164088|NCT00004207|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of liposomal daunorubicin in treating     patients who have metastatic breast cancer.   "
164089|NCT00004208|"     The main objective of this trial is to evaluate the efficacy and toxicity of intensive     immuno-suppression with ATG + CSA versus best supportive care in patients with transfusion     dependent low and intermediate risk myelodysplastic syndrome (MDS).   "
164090|NCT00004209|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether three courses of combination chemotherapy are more effective than six     courses of combination chemotherapy for non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of three courses of     combination chemotherapy with that of six courses of combination chemotherapy in treating     patients who have stage IIIB or stage IV non-small cell lung cancer.   "
164091|NCT00004210|"     RATIONALE: Identifying family and individual characteristics may help plan education and     counseling for patients who are considering genetic testing.      PURPOSE: This clinical trial is studying education and counseling to see what effect they     have in patients who are undergoing genetic testing for hereditary nonpolyposis colon cancer     (recruitment of new families with HNPCC stopped as of 04-26-06, recruitment of persons within     families already participating continues).   "
164092|NCT00004211|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients     who have metastatic prostate cancer.   "
164093|NCT00004212|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of DX-8951f in treating children who have     advanced solid tumors or lymphomas that have not responded to previous therapy.   "
164094|NCT00004213|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of 3-aminopyridine-2-carboxaldehyde     thiosemicarbazone in treating patients who have solid tumors that have not responded to     previous treatment.   "
182989|NCT00237848|"     This study will examine the effectiveness of D-serine in increasing and sustaining the     benefits of cognitive retraining in people with schizophrenia.   "
164095|NCT00004215|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Colony-stimulating factors such as leridistim and filgrastim     increase the number of immune cells found in bone marrow or peripheral blood and may help a     person's immune system recover from the side effects of chemotherapy.      PURPOSE: Randomized phase II trial to compare the effectiveness of leridistim with that of     filgrastim to reduce side effects in older patients who are receiving cytarabine and     daunorubicin for acute myeloid leukemia.   "
164096|NCT00004216|"     RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune     system and stop cancer cells from growing.      PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have     advanced or metastatic solid tumors that have not responded to previous therapy.   "
164097|NCT00004217|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. PSC 833 may help chemotherapy drugs kill more cancer cells by     making them more sensitive to the drugs.      PURPOSE: Phase II trial to study the effectiveness of PSC 833, daunorubicin, and cytarabine     in treating older patients who have newly diagnosed acute myeloid leukemia.   "
164098|NCT00004218|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. It is not yet known which regimen of chemotherapy is more     effective for chronic lymphocytic leukemia.      PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works     compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with     newly diagnosed chronic lymphocytic leukemia.   "
164099|NCT00004219|"     RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients     treated with radiation therapy. It is not yet known whether lerisetron is more effective than     granisetron in preventing nausea and vomiting.      PURPOSE: Randomized phase III trial to compare the effectiveness of lerisetron with that of     granisetron in preventing nausea and vomiting in men who are being treated with radiation     therapy for stage I seminoma.   "
164100|NCT00004220|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and gemcitabine in treating     patients who have advanced cancer.   "
164101|NCT00004221|"     Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem     cell transplantation in treating patients who have undergone surgery for stage III ovarian     cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.   "
164102|NCT00004223|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating     patients who have progressive regional or metastatic bladder cancer.   "
164103|NCT00004224|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug and combining chemotherapy with radiation therapy may kill more     tumor cells.      PURPOSE: This phase II trial is studying combination chemotherapy and radiation therapy to     see how well they work in treating children with localized ependymoma.   "
164104|NCT00004225|"     RATIONALE: Inserting the gene for p53 into a person's cancer cells may improve the body's     ability to fight cancer. Radiation therapy uses high-energy x-rays to damage tumor cells.      PURPOSE: Phase I trial to study the effectiveness of gene therapy plus radiation therapy in     treating patients who have non-small cell lung cancer.   "
164105|NCT00004226|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy following surgery     in treating patients who have recurrent or second primary cancer of the head and neck     following previous radiation therapy.   "
164124|NCT00004246|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus fludarabine in     treating patients who have locally advanced cancer of the mouth, pharynx, or larynx.   "
164106|NCT00004227|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal     antibodies such as cetuximab can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. It is not yet known if     radiation therapy is more effective with or without cetuximab for cancer of the oropharynx,     hypopharynx, or larynx.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without cetuximab in treating patients who have stage III or stage IV cancer of the     oropharynx, hypopharynx, or larynx.   "
164107|NCT00004228|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. It is not yet known which regimen of combination chemotherapy is     most effective for lymphoblastic lymphoma.      PURPOSE: This randomized phase III trial is studying different regimens of combination     chemotherapy to compare how well they work in treating children or adolescents with newly     diagnosed stage III or stage IV lymphoblastic lymphoma.   "
164108|NCT00004229|"     Phase I trial to study the effectiveness of endostatin in treating patients who have advanced     solid tumors. Endostatin may stop the growth of cancer by stopping blood flow to the tumor.   "
164109|NCT00004230|"     RATIONALE: Captopril may protect the lungs from the side effects of bone marrow or stem cell     transplantation.      PURPOSE: Randomized phase III trial to determine the effectiveness of captopril to lessen the     side effects in patients who are undergoing bone marrow or stem cell transplantation     following chemotherapy and radiation therapy.   "
164164|NCT00004312|"     OBJECTIVES: I. Establish a computerized databank to monitor the progress of patients with     cystinosis treated with cysteamine.      II. Track and monitor all patients including renal transplant, dialysis and post renal     transplants.   "
164110|NCT00004231|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     cancer cells. Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     bone marrow or peripheral stem cell transplantation and/or biological therapy in treating     patients who have stage III, stage IV, or recurrent mantle cell lymphoma.   "
164111|NCT00004232|"     RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune     cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of bone marrow and peripheral stem cell     transplantation in treating patients who have hematologic cancer.   "
164112|NCT00004233|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs such as triacetyluridine may protect normal     cells from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of triacetyluridine, fluorouracil, and     leucovorin in treating patients who have unresectable, locally advanced, or metastatic cancer     of the esophagus or stomach.   "
164113|NCT00004234|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation     therapy at different times of the day may affect the chance of developing side effects such     as mucositis.      PURPOSE: Randomized phase III trial to compare the incidence of mucositis in patients who     have cancer of the mouth, pharynx, or larynx, who are receiving radiation therapy in either     the morning or afternoon.   "
164114|NCT00004235|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and irinotecan in     treating patients who have advanced cancer of the esophagus or stomach.   "
164115|NCT00004236|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating     patients who have advanced stomach cancer.   "
164116|NCT00004237|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying three regimens of combination     chemotherapy to compare how well they work in treating women with stage I or stage II breast     cancer.   "
164117|NCT00004238|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in     treating patients who have stage IIIB or stage IV non-small cell lung cancer.   "
164118|NCT00004239|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of 506U78 in treating patients who have     hematologic cancer and kidney or liver impairment.   "
164119|NCT00004241|"     Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they     stop growing or die. This phase I trial is studying the side effects and best dose of     17-N-allylamino-17-demethoxygeldanamycin in treating patients with advanced epithelial     cancer, malignant lymphoma, or sarcoma   "
164120|NCT00004242|"     Phase I trial to study the effectiveness of combination chemotherapy in treating patients who     have metastatic or unresectable solid tumors. Drugs used in chemotherapy use different ways     to stop tumor cells from dividing so they stop growing or die. Combining more than one drug     may kill more tumor cells.   "
164121|NCT00004243|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of docetaxel and oxaliplatin in treating     patients who have metastatic or recurrent solid tumor.   "
164122|NCT00004244|"     This phase I trial is studying the side effects and best dose of interleukin-12 and     interferon alfa in treating patients with metastatic kidney cancer or malignant melanoma.     Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a     person's white blood cells to kill cancer cells. Interferon alfa may interfere with the     growth of cancer cells. Combining interleukin-12 and interferon alfa may kill more cancer     cells.   "
164123|NCT00004245|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of sodium salicylate in treating patients     who have advanced myelodysplastic syndrome , acute myelogenous leukemia or chronic     lymphocytic leukemia.   "
164125|NCT00004248|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill     liver cancer cells.      PURPOSE: Phase II trial to study the effectiveness of doxorubicin and interleukin- 2 in     treating patients who have liver cancer that cannot be removed by surgery.   "
164126|NCT00004249|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Biological therapies, such as QS21, use different ways to stimulate the immune system and     stop cancer cells from growing.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus QS21 in treating     patients who have small cell lung cancer that has responded to initial therapy.   "
164127|NCT00004250|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Infusing chemotherapy to the tumor area only may kill more tumor     cells and cause less damage to healthy tissues.      PURPOSE: This phase II trial is studying isolated limb infusion of chemotherapy to see how     well it works in treating patients with melanoma or soft tissue sarcoma of the arm or leg     that cannot be removed by surgery.   "
164128|NCT00004251|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of letrozole in treating women who have     recurrent or metastatic endometrial cancer.   "
164129|NCT00004252|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. SU5416 may stop the growth of colorectal cancer by stopping blood     flow to the tumor. It is not yet known whether chemotherapy is more effective with or without     SU5416 in treating metastatic colorectal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of leucovorin and     fluorouracil with or without SU5416 in treating patients who have metastatic colorectal     cancer.   "
164130|NCT00004253|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Specialized radiation therapy delivers a high dose of radiation     directly to the tumor which may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and     specialized high-dose radiation therapy in treating patients who have stage II or stage III     non-small cell lung cancer that cannot be removed by surgery.   "
164131|NCT00004254|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of raltitrexed in treating patients who     have malignant mesothelioma that cannot be surgically removed.   "
164132|NCT00004255|"     RATIONALE: Bone marrow that has been treated to remove certain white blood cells may reduce     the chance of developing graft-versus-host disease following bone marrow transplantation.      PURPOSE: Randomized phase II/III trial to compare the effectiveness of treated bone marrow     with that of untreated bone marrow in preventing graft-versus-host disease in patients with     acute or chronic leukemia who are undergoing bone marrow transplantation.   "
164133|NCT00004256|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     sargramostim may protect normal cells from the side effects of radiation therapy.      PURPOSE: Randomized phase II trial to determine the effectiveness of sargramostim in     preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer.   "
164134|NCT00004257|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug and combining chemotherapy with radiation therapy may kill more     tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin and fluorouracil     plus radiation therapy in treating patients who have primary esophageal or stomach cancer.   "
164135|NCT00004258|"     RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor.      PURPOSE: Phase I trial to study the effectiveness of EMD 121974 in treating patients who have     locally advanced or metastatic cancer.   "
164136|NCT00004259|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy, such as temozolomide, carmustine, and lomustine, use different ways to stop     tumor cells from dividing so they stop growing or die. Combining radiation therapy with     chemotherapy may kill more tumor cells.      PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to     see how well they work compared to radiation therapy and carmustine or lomustine in treating     patients with anaplastic astrocytoma or mixed gliomas.   "
164137|NCT00004260|"     RATIONALE: Interleukin-12 may stimulate a person's white blood cells to kill lymphoma cells.     Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or     deliver cancer-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of interleukin-12 plus rituximab in     treating patients who have non-Hodgkin's lymphoma.   "
164138|NCT00004261|"     RATIONALE: EF5 may detect the presence of oxygen in tumor cells and help plan effective     cancer treatment.      PURPOSE: Phase I trial to study the effectiveness of EF5 in detecting the presence of oxygen     in tumor cells of patients who are undergoing surgery or biopsy for breast, prostate, or     cervical cancer or high grade soft tissue sarcoma.   "
164139|NCT00004262|"     Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in     treating patients who have supratentorial glioblastoma multiforme. Radiation therapy uses     high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the     tumor cells more sensitive to radiation therapy.   "
164140|NCT00004263|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. UCN-01 may make cancer cells more sensitive to cytarabine.      PURPOSE: Phase I trial to study the effectiveness of cytarabine and UCN-01 in treating     patients who have refractory or relapsed acute myelogenous leukemia or myelodysplastic     syndrome.   "
164141|NCT00004264|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells     from the side effects of chemotherapy.      PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel, cisplatin, and     amifostine in treating patients who have advanced non-small cell lung cancer that cannot be     surgically removed.   "
164143|NCT00004266|"     OBJECTIVES:      I. Establish a long-term working relationship between clinical investigators and the     Minnesota American Indian community.      II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and     nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in     Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria.      III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A     reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol     Education Program in preventing nephropathy and vascular diseases in these patients.   "
164144|NCT00004268|"     OBJECTIVES: I. Study further the safety and efficacy of the alpha-receptor agonist midodrine     in patients with neurogenic orthostatic hypotension.      II. Assess the quality of life in these patients with this treatment regimen.   "
164145|NCT00004274|"     RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X     chromosome and do not produce estrogen. Giving estrogen is standard treatment for girls who     have Turner's syndrome. Estrogen may be effective treatment for mental and social functioning     problems experienced by girls with Turner's syndrome.      PURPOSE: Clinical trial to study the effectiveness of long term estrogen therapy on mental     and social functioning in girls who have Turner's syndrome.   "
164146|NCT00004275|"     RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X     chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may     help girls with Turner's syndrome attain a more normal height. It is not yet known if growth     hormone is more effective with or without oxandrolone for Turner's syndrome.      PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who     have growth hormone-treated Turner's syndrome.   "
164147|NCT00004276|"     OBJECTIVES: I. Evaluate whether thalidomide modulates toxic host inflammatory responses in     patients receiving antitubercular therapy.      II. Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of     HIV and mycobacterial infections, and limits progression of HIV immunodeficiency.      III. Evaluate whether thalidomide stimulates immunity in patients with HIV and/or     mycobacterial infections.   "
164148|NCT00004278|"     OBJECTIVES:      I. Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates     with symptomatic congenital cytomegalovirus infection with central nervous system disease.   "
164149|NCT00004284|"     OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium     phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with     absorptive hypercalciuria.      II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate     to that of potassium citrate.   "
164150|NCT00004285|"     OBJECTIVES: I. Evaluate whether hemodialysis providing a 2-pool, variable volume urea kinetic     modelling value of 1.05 versus 1.45 reduces mortality and morbidity in patients with end     stage renal disease.      II. Compare the efficacy of high versus low flux dialyzer membranes.   "
164151|NCT00004286|"     OBJECTIVES:      I. Compare and evaluate the response to treatment with intravenous human immune globulin     (IVIG) or placebo in previously untreated patients with chronic inflammatory demyelinating     polyneuropathy.   "
164152|NCT00004287|"     OBJECTIVES:      I. Assess the safety and feasibility of gene transfer with the third generation adenovirus     H5.001CBCFTR in patients with cystic fibrosis.   "
164153|NCT00004288|"     OBJECTIVES:      I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men     with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and     physiotherapy.   "
164154|NCT00004293|"     OBJECTIVES:      I. Evaluate the efficacy and toxicity of glucocerebrosidase enzyme therapy in patients with     Gaucher disease.   "
164155|NCT00004294|"     OBJECTIVES: I. Transfer the human glucocerebrosidase (GC) gene into peripheral blood stem     cells (PBSC) obtained from patients with type I Gaucher disease using a retroviral vector.      II. Transplant the autologous transduced PBSC in these patients. III. Measure the carriage     and expression of the transferred gene and its duration in peripheral blood leukocytes.      IV. Assess the clinical effects of transplanting genetically corrected PBSC.   "
164156|NCT00004296|"     OBJECTIVES: I. Determine the prevalence of nontuberculous mycobacteria in sputum cultures     from patients with cystic fibrosis.      II. Compare the clinical course of patients with negative versus positive cultures.   "
164157|NCT00004297|"     OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and     complications of diazepam and lorazepam given intravenously as prehospital therapy to     patients in status epilepticus.      II. Determine the effect of prehospital therapy on the incidence of status epilepticus at the     subsequent emergency department admission.      III. Establish whether prehospital therapy alters hospital management of these patients and     ultimately affects patient outcome.   "
164158|NCT00004300|"     OBJECTIVES: I. Determine differences between persons with repetitive behavior disorders and     matched controls on measures of motor control relevant to basal ganglia pathophysiology.      II. Determine the efficacy of bromocriptine, a dopamine agonist, in the treatment of     stereotyped behavior and related behavior disorders.      III. Determine the efficacy of sertraline hydrochloride, a selective serotonin uptake     inhibitor, in the treatment of repetitive behavior disorders.      IV. Identify behavioral, environmental, and biological variables with differential drug     treatment response.   "
164159|NCT00004305|"     OBJECTIVES: I. Determine whether allelic differences associated with the fourth component of     complement, type-1 complement receptor expressed on erythrocytes, and Fc receptor FcgRIII     contribute to the pathogenesis of IgA glomerulonephritis (IgA-N).      II. Compare genetic anomalies of these key components in immune complex processing and     clearance between juvenile vs adult onset IgA-N vs normal controls.   "
164160|NCT00004306|"     OBJECTIVES: I. Clinically evaluate members from families with a dominantly inherited ataxia     and collect blood, skin and muscle samples for detailed molecular studies.      II. Perform detailed clinical evaluations on patients with recessively inherited ataxias.   "
164192|NCT00003066|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of docetaxel combined with estramustine in     treating women with metastatic breast cancer.   "
164161|NCT00004307|"     RATIONALE: The urea cycle is the process in which nitrogen is removed from the blood and     converted into urea, a waste product found in urine . Urea cycle disorders are inherited     disorders caused by the lack of an enzyme that removes ammonia from the bloodstream. Gene     therapy is treatment given to change a gene so that it functions normally. Studying the     treatment and metabolism of patients with urea cycle disorders may be helpful in developing     new treatments for these disorders.      PURPOSE: Two-part clinical trial to study the treatment and metabolism of patients who have     urea cycle disorders.   "
164162|NCT00004310|"     OBJECTIVES:      I. Evaluate the efficacy of intravenous versus oral pulse loading of clomipramine (CMI)     followed by a 12-week course of maintenance therapy in patients with obsessive compulsive     disorder.   "
164163|NCT00004311|"     OBJECTIVES: I. Evaluate insulin resistance in thin and obese hyperandrogenic women with     polycystic ovarian disease or hyperandrogenism insulin resistance acanthosis nigricans     syndrome and in thin and obese controls, using an estimation of tissue sensitivity to     insulin.      II. Evaluate the effect of androgen suppression with leuprolide acetate and spironolactone on     insulin secretion and resistance.   "
164165|NCT00004313|"     OBJECTIVES:      I. Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone,     for patients with primary adrenal insufficiency (Addison's disease).   "
164166|NCT00004314|"     OBJECTIVES: I. Determine the effects of aminoimidazole carboxamide riboside (AICAR) on     hematologic manifestations of Lesch-Nyhan disease.      II. Assess the behavioral and neurological benefits of AICAR in patients with Lesch-Nyhan     disease.      III. Examine the effect of AICAR on purine production.   "
164167|NCT00004315|"     OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol     (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated     liver disease or chronic cholestatic liver disease.      II. Compare the differences in pruritus, weight gain, and liver function for both treatments.   "
164168|NCT00004316|"     OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with     interstitial cystitis.      II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in     patients with vulvar vestibulitis.      III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar     skin.      IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and     prostaglandin.   "
164169|NCT00004317|"     RATIONALE: Congenital toxoplasmosis is an infection caused by the parasitic organism     Toxoplasma gondii, and it may be passed from an infected mother to her unborn child. The     mother may have mild symptoms or no symptoms; the fetus, however, may experience damage to     the eyes, nervous system, skin, and ears. The newborn may have a low birth weight, enlarged     liver and spleen, jaundice, anemia, petechiae, and eye damage. Giving the antiparasitic drugs     pyrimethamine and sulfadiazine is standard treatment for congenital toxoplasmosis, but it is     not yet known which regimen of pyrimethamine is most effective for the disease.      PURPOSE: Randomized phase IV trial to determine which regimen of pyrimethamine is most     effective when combined with sulfadiazine and leucovorin in treating patients who have     congenital toxoplasmosis.   "
164170|NCT00004323|"     OBJECTIVES: I. Evaluate the efficacy of related, HLA-identical bone marrow transplantation     following cyclophosphamide (CTX) and antithymocyte globulin in patients with aplastic anemia.      II. Evaluate the efficacy of related, HLA-nonidentical bone marrow transplantation following     CTX and total-body irradiation/total-lymphoid irradiation in patients with aplastic anemia.   "
164171|NCT00004324|"     OBJECTIVES: I. Characterize the natural history, associated features, and severity of     symptoms of obsessive compulsive disorder and Tourette syndrome in children and adolescents.      II. Identify factors that influence the clinical course and prognosis of these patients.   "
164172|NCT00004325|"     OBJECTIVES: I. Investigate the pathobiology of Tourette syndrome and related disorders by     measuring various compounds of interest in cerebrospinal fluid, plasma, and urine of patients     with Tourette syndrome, obsessive compulsive disorder, and/or chronic tics.      II. Determine the pattern of familial aggregation of Tourette syndrome and obsessive     compulsive disorder by systematic assessment of all first-degree family members of patients     selected for cerebrospinal fluid studies.      III. Establish the neurochemical and neuropeptide profile associated with the range of     expression of the putative Tourette gene expression in adult and adolescent patients.   "
164173|NCT00004326|"     OBJECTIVES: I. Evaluate whether chronic hypercortisolemia is specifically toxic to     hippocampal cells and causes structural reduction of hippocampal volume in patients with     Cushing's syndrome.      II. Determine whether reduced hippocampal volume is associated with specific memory     dysfunction.      III. Examine the relationships of adrenal androgen to hippocampal volume and memory     dysfunction.      IV. Examine the reversibility of hippocampal structural changes and cognitive dysfunction     after cortisol levels are normalized.   "
164174|NCT00004327|"     OBJECTIVES:      I. Evaluate the efficacy of octreotide, a somatostatin octapeptide analog, in decreasing     gastrointestinal bleeding in patients with hormone-refractory hereditary hemorrhagic     telangiectasia or senile ectasia.   "
164175|NCT00003046|"     RATIONALE: Interleukin-12 may kill tumor cells by stimulating a person's white blood cells to     kill cancer cells.      PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients with     cancer in the abdomen.   "
164176|NCT00003048|"     RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome.      PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with     myelodysplastic syndrome.   "
164193|NCT00003067|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill     cancer cells in patients with primary or advanced glioma.      PURPOSE: Clinical trial to study the effectiveness of biological therapy with interleukin-2     and lymphokine-activated killer cells in treating patients who have primary, recurrent, or     refractory malignant glioma.   "
164728|NCT00005303|"     To determine the effectiveness of efforts to eliminate the human immunodeficiency virus (HIV)     from whole blood and blood components in the blood supply.   "
164177|NCT00003049|"     RATIONALE: Surgery to remove the pancreas, some of the small intestine, and lymph nodes may     be more effective treatment for cancer of the pancreas than surgery to remove the pancreas     and some of the small intestine alone. Radiation therapy uses high-energy x-rays to damage     tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing     so they stop growing or die. Combining surgery, radiation therapy, and chemotherapy may be an     effective treatment for cancer of the pancreas.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the     pancreas and a portion of the small intestine with or without removing lymph nodes, followed     by radiation therapy and chemotherapy, in treating patients with cancer of the pancreas.   "
164178|NCT00003050|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in     treating patients with stage IIB or stage III breast cancer.   "
164196|NCT00003072|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving the drugs in different     combinations may kill more tumor cells.      PURPOSE: Randomized phase II double-blinded trial to study the effectiveness of paclitaxel     and carboplatin given with either amifostine or placebo in patients with metastatic stage III     or stage IV ovarian cancer or metastatic stage III or stage IV non-small cell lung cancer.   "
164179|NCT00003052|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several     degrees above body temperature. It is not known whether receiving chemotherapy plus     hyperthermia is more effective than receiving chemotherapy alone in treating patients with     soft tissue sarcoma.      PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see     how well it works compared to combination chemotherapy and hyperthermia therapy in treating     patients with soft tissue sarcoma.   "
164180|NCT00003053|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy     in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer     that has been surgically removed.   "
164181|NCT00003054|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with     recurrent or persistent cancer of the uterus.   "
164182|NCT00003055|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients with locally advanced or metastatic esophageal or gastric cancer.   "
164183|NCT00003056|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the     transplanted cells can make an immune response against the body's normal tissues.      PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine plus     methotrexate with cyclosporine plus T cell depletion for prevention of graft-versus-host     disease during peripheral stem cell transplantation in patients who have advanced leukemia or     lymphoma who are eligible for transplanted peripheral stem cells from a donor.   "
164184|NCT00003057|"     RATIONALE: Drugs such as octreotide and loperamide hydrochloride use different ways to     relieve the diarrhea caused by chemotherapy.      PURPOSE: Randomized phase III trial to compare the effectiveness of octreotide with     loperamide hydrochloride for the treatment of chemotherapy-related diarrhea in patients who     have colorectal cancer.   "
164185|NCT00003058|"     Troglitazone may help liposarcoma cells develop into normal cells. This was a single arm,     open-label study with a two-stage design to evaluate troglitazone in patients with     liposarcoma stratified by histologic subtype.   "
164186|NCT00003060|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow     the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Clinical trial to study the effectiveness of chemotherapy plus bone marrow     transplantation in treating patients with metastatic melanoma that has not responded to     previous therapy.   "
164187|NCT00003061|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus     radiation therapy in treating patients who have primary CNS lymphoma.   "
164188|NCT00003062|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effect of temozolomide in patients with progressive or     recurrent stage IV non-small cell lung cancer, with or without brain metastases, who have not     been treated for metastatic disease with chemotherapy.   "
164189|NCT00003063|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor     cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using     levamisole with treatment using interferon alfa and combination chemotherapy consisting of     fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.   "
164190|NCT00003064|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and autologous     peripheral stem cell transplantation in treating patients with recurrent or persistent     epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.   "
164191|NCT00003065|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating     patients who have recurrent or metastatic cancer of the cervix.   "
164245|NCT00003126|"     The purpose of this study is to assess the efficacy of post-operative high-dose bolus     interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).   "
164194|NCT00003068|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose mitoxantrone, thiotepa, and     cyclophosphamide plus autologous peripheral stem cell transplantation and amifostine in     treating patients with primary, locally advanced, or stage IV breast cancer.   "
164195|NCT00003070|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs, such as enalapril, may protect normal cells     from the toxic effects of chemotherapy. It is not known whether enalapril is more effective     than a placebo in treating heart damage in patients who received anthracycline chemotherapy     for childhood cancer.      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of enalapril     with a placebo in treating heart damage in patients who received anthracycline chemotherapy     for childhood cancer.   "
164197|NCT00003073|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of liposomal cytarabine in treating young     patients who have recurrent or refractory meningeal leukemia, lymphoma, or solid tumors.   "
164198|NCT00003075|"     RATIONALE: Chemoprevention uses drugs to try and prevent development of cancer. Fenretinide     may be effective in treating cervical neoplasia and preventing cervical cancer.      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of     fenretinide to placebo in treating patients with cervical neoplasia.   "
164199|NCT00003076|"     RATIONALE: Chemoprevention therapy is the use of drugs to try and prevent the development or     recurrence of cancer. It is not known whether eflornithine is effective in preventing cancer     in patients with Barrett's esophagus.      PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of eflornithine     in preventing cancer in patients with Barrett's esophagus.   "
164200|NCT00003077|"     RATIONALE: Omega-3 fatty acids are used by the body for energy and tissue development and may     be an effective treatment for patients with advanced cancer who are unable to maintain their     body weight.      PURPOSE: Phase I/II trial to study the effectiveness of omega-3 fatty acids in treating     patients with advanced cancer who have significant weight loss.   "
164201|NCT00003078|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining radiation therapy and chemotherapy may kill more tumor cells. It is not known     whether receiving radiation therapy plus cisplatin is more effective than receiving radiation     therapy plus fluorouracil in treating patients with cancer of the cervix.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus     cisplatin or fluorouracil in treating patients with primary stage IIB, stage IIIB, or stage     IVA cancer of the cervix.   "
164202|NCT00003079|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 and high dose cytarabine in     treating patients with refractory or relapsed acute myelocytic or acute lymphocytic leukemia,     chronic myelogenous leukemia or refractory or relapsed lymphoblastic lymphoma.   "
164203|NCT00003080|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of sequential chemotherapy followed by     peripheral stem cell transplantation in treating patients with persistent or platinum     refractory stage III or stage IV ovarian cancer.   "
164204|NCT00003081|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.     Radiation therapy uses high-energy x-rays to damage tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy, peripheral     stem cell transplantation, and radiation therapy in treating patients with recurrent     metastatic Ewing's sarcoma, peripheral primitive neuroectodermal tumor, or rhabdomyosarcoma.   "
164205|NCT00003082|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibodies in treating     patients who have advanced cancer.   "
164206|NCT00003084|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy     consisting of paclitaxel, etoposide, and estramustine as compared with ketoconazole plus     doxorubicin, vinblastine, and estramustine in treating patients with prostate cancer.   "
164207|NCT00003085|"     RATIONALE: New diagnostic procedures, such as laparoscopic ultrasound, may improve the     ability to detect pancreatic cancer and determine the extent of disease.      PURPOSE: Phase II trial to study the effectiveness of laparoscopic ultrasound in diagnosing     patients with stage I or stage II pancreatic cancer.   "
164208|NCT00003086|"     RATIONALE: Bone marrow transplantation may allow the doctor to give higher doses of     chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of repeated use of high-dose     chemotherapy plus bone marrow transplantation and samarium 153 in treating women who have     stage IV breast cancer.   "
164729|NCT00005304|"     To determine the prevalence of hepatitis delta virus (HDV) in a large cohort of hemophiliacs     and to elucidate the role of HDV in the development and progression of liver disease in this     population.   "
164209|NCT00003087|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug with radiation therapy before surgery may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation     therapy, and surgery in treating patients with cancer of the esophagus that can be surgically     removed.   "
164210|NCT00003088|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving drugs at different times or combining more than one drug may     kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for     breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting     of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of     combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by     paclitaxel in treating women with stage II or stage IIIA breast cancer.   "
164211|NCT00003089|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells     from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel, carboplatin, amifostine,     and radiation therapy in treating patients who have unresectable locally advanced or     partially resected non-small cell lung cancer.   "
164212|NCT00003090|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill non-small cell     lung cancer cells.      PURPOSE: Phase II trial to study the effect of biological therapy with interleukin-2 in     patients with previously treated non-small cell lung cancer.   "
164213|NCT00003091|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may     stimulate a person's white blood cells to kill kidney cancer or melanoma cells.      PURPOSE: Phase II trial to study the effectiveness of high-dose interferon alfa and     interleukin-2 in treating patients with metastatic kidney cancer or melanoma.   "
164214|NCT00003092|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase III trial to study the effectiveness of paclitaxel in treating older patients     who have solid tumors.   "
164215|NCT00003093|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Combination     chemotherapy plus surgery may be an effective treatment for neuroblastoma.      PURPOSE: This phase III trial is studying how well combination chemotherapy followed by     surgery works in treating young patients with neuroblastoma.   "
164216|NCT00003094|"     RATIONALE: A diet rich in carotenoids may be an effective treatment for cervical dysplasia.      PURPOSE: Randomized phase II trial to study the effectiveness of a carotenoid rich diet in     treating patients with cervical dysplasia.   "
164217|NCT00003095|"     RATIONALE: Drugs used in chemotherapy for breast cancer may damage the genes of cells. This     may lead to the development of secondary cancers.      PURPOSE: Pilot study to evaluate the degree of gene damage following chemotherapy in women     with stage II or stage III breast cancer involving four to nine axillary lymph nodes.   "
164218|NCT00003096|"     RATIONALE: Analyzing the number and structure of genes found in a child's cancer cells may     help doctors improve methods of diagnosing and treating children with brain tumors.      PURPOSE: This clinical trial is studying the number and structure of genes in cancer cells of     children with brain tumors.   "
164219|NCT00003097|"     RATIONALE: A low-fat, balanced diet may prevent disease progression in patients with     nonmelanomatous skin cancer.      PURPOSE: Randomized phase II trial to study the effectiveness of a low-fat, balanced diet to     prevent disease progression in patients with nonmelanomatous skin cancer.   "
164220|NCT00003098|"     RATIONALE: The amount of dietary fat or fiber may affect estrogen metabolism in     postmenopausal women, and this may affect the risk of developing cancer.      PURPOSE: Randomized dietary intervention to study the effectiveness of a low-fat diet     combined with either high fiber or low fiber on estrogen metabolism in healthy postmenopausal     women.   "
164221|NCT00003099|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of fenretinide and tamoxifen before surgery may     be an effective way to prevent the recurrence of or further development of breast cancer.      PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide and tamoxifen     given before surgery in treating women with breast cancer.   "
164222|NCT00003100|"     RATIONALE: Eating a diet rich in soy foods appears to reduce the risk of some types of     cancer. Isoflavones are compounds found in soy food that may prevent the development of     cancer.      PURPOSE: Clinical trial to determine the most effective amount and type of soy isoflavones     needed in the diets of healthy men and women to prevent cancer.   "
164223|NCT00003101|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and combining chemotherapy with     autologous bone marrow transplantation or peripheral stem cell transplantation may allow     doctors to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bone     marrow transplantation or peripheral stem cell transplantation in treating patients who have     oligodendroglioma.   "
164224|NCT00003102|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in     treating patients with advanced kidney cancer.   "
164225|NCT00003103|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of oblimersen in treating patients who     have solid tumors that have not responded to previous therapy.   "
164226|NCT00003104|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Computer systems     that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment     may result in more effective radiation therapy.      PURPOSE: This phase II trial is studying how well radiation therapy that has been planned     with a computer works in treating patients with prostate cancer.   "
164227|NCT00003105|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating     patients with metastatic or locally advanced bladder cancer.   "
164228|NCT00003107|"     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by     stimulating a person's white blood cells to kill cancer cells.      PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients who     have hematologic cancer or solid tumor.   "
164229|NCT00003108|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of cisplatin plus bryostatin 1 in treating     patients who have advanced cancer.   "
164230|NCT00003109|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of irinotecan plus raltitrexed in treating     patients who have refractory solid tumors that have not responded to previous therapy.   "
164231|NCT00003110|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of bleomycin in treating patients with     non-Hodgkin's lymphoma.   "
164232|NCT00003111|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with     irinotecan and cisplatin followed by surgery in treating patients with stage IIIA non-small     cell lung cancer.   "
164233|NCT00003113|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving the drugs in different ways     may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of oral combination chemotherapy and G-CSF     in elderly patients with intermediate- or high-grade non-Hodgkin's lymphomas.   "
164234|NCT00003114|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with     lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients with stage IIB,     stage III, or stage IV AIDS-related Hodgkin's disease.   "
164235|NCT00003115|"     RATIONALE: Giving hydromorphone in different ways may relieve the pain associated with cancer     surgery.      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of epidural     hydromorphone with hydromorphone infusion in patients with prostate cancer undergoing radical     prostatectomy.   "
164236|NCT00003116|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving busulfan, cyclophosphamide, and     filgrastim together with peripheral stem cell transplantation from a sibling donor works in     treating patients with hematologic cancer.   "
164237|NCT00003117|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or     without carboplatin in treating patients who have recurrent, stage IIIB, or stage IV     non-small cell lung cancer.   "
164238|NCT00003118|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It     is not yet known whether surgery is more effective with or without chemotherapy and radiation     therapy for cancer of the esophagus.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without     combination chemotherapy and radiation therapy in treating patients who have cancer of the     esophagus that can be surgically removed.   "
164239|NCT00003119|"     RATIONALE: Surgery alone may be effective in treating children with neuroblastoma.      PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who     have neuroblastoma.   "
164240|NCT00003120|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. It is not yet known whether giving paclitaxel for a shorter     period of time is as effective as a standard course of treatment for advanced ovarian cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel given for 3     months with that of paclitaxel given for 12 months in treating patients who have stage III or     stage IV ovarian, fallopian tube, or primary peritoneal cancer.   "
164241|NCT00003122|"     RATIONALE: Surgery may be an effective treatment for neuroblastoma.      PURPOSE: This phase II trial is studying how well surgery works in treating patients with     neuroblastoma.   "
164242|NCT00003123|"     RATIONALE: Amifostine may be effective in helping blood counts return to normal in treating     patients with myelodysplastic syndrome.      PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with     advanced myelodysplastic syndrome.   "
164243|NCT00003124|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using     leuprolide and flutamide may fight prostate cancer by reducing the production of androgens.     Combining radiation therapy with hormone therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy     in treating patients with prostate cancer.   "
164244|NCT00003125|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Colony-stimulating factors such as sargramostim may increase the number of immune cells.     Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining     vaccine therapy, sargramostim, and interleukin-2 may kill more cancer cells.      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy,     sargramostim, and interleukin-2 in treating patients who have advanced tumors.   "
164246|NCT00003127|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients with metastatic, recurrent, or refractory endometrial cancer.   "
164247|NCT00003128|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether ifosfamide alone is more effective than     ifosfamide plus paclitaxel in treating patients with cancer of the uterus.      PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with or     without paclitaxel in treating patients with advanced, refractory, or recurrent cancer of the     uterus.   "
164248|NCT00003129|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with     early-stage bladder cancer that has not responded to BCG therapy.   "
164249|NCT00003130|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women who have     recurrent solid tumors.   "
164250|NCT00003131|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating patients with acute     myeloid leukemia in first relapse.   "
164251|NCT00003132|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus cisplatin in treating     patients who have metastatic or unresectable cancer.   "
164252|NCT00003133|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following     surgery in treating patients with advanced bladder cancer.   "
164253|NCT00003134|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who     have recurrent glioma.   "
164254|NCT00003135|"     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above     body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. Combining chemotherapy with hyperthermia may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving fluorouracil and liposomal     doxorubicin together with systemic hyperthermia works in treating patients with metastatic     breast, ovarian, endometrial, or cervical cancer.   "
164255|NCT00003136|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of amifostine, carboplatin and     cyclophosphamide, followed by peripheral stem cell transplantation, in treating patients with     epithelial ovarian cancer or primary peritoneal cancer.   "
164256|NCT00003137|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who     have advanced cancer of the stomach.   "
164257|NCT00003138|"     RATIONALE: Erythropoietin and colony-stimulating factors such as filgrastim stimulate the     production of blood cells. It is not yet known whether erythropoietin with or without     filgrastim is more effective than standard blood transfusions in reducing the need for     transfusions in patients who have anemia associated with myelodysplastic syndrome.      PURPOSE: Randomized phase III trial to compare the effectiveness of erythropoietin with or     without filgrastim with that of standard blood transfusions in reducing the need for     transfusions in patients who have anemia associated with myelodysplastic syndrome.   "
164258|NCT00003139|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     pilocarpine may protect normal cells from the side effects of radiation therapy. It is not     yet known if pilocarpine may be effective in preventing mucositis and dry mouth in patients     receiving radiation therapy for head and neck cancer.      PURPOSE: Randomized, double-blinded, phase III trial to study the effectiveness of     pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for     head and neck cancer.   "
164259|NCT00003140|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by reducing the production of estrogen.      PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in     treating women with breast cancer who have received tamoxifen for at least 5 years.   "
164260|NCT00003141|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral     stem cell transplantation in treating infants with malignant brain or spinal cord tumors.   "
164261|NCT00003143|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal     cells from the side effects of chemotherapy.      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy     with or without amifostine in treating patients with recurrent or refractory non-Hodgkin's     lymphoma or Hodgkin's disease who are undergoing autologous stem cell transplantation.   "
164262|NCT00003144|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells     from the bad side effects of chemotherapy.      PURPOSE: Randomized phase I trial to study the effectiveness of amifostine in treating     patients who are receiving chemotherapy for recurrent or refractory solid tumors.   "
164263|NCT00003145|"     This clinical trial studies fludarabine phosphate, low-dose total-body irradiation, and     peripheral blood stem cell transplant followed by donor lymphocyte infusion in treating older     patients with chronic myeloid leukemia. Giving chemotherapy and total-body irradiation before     a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells     from a donor are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells     from a donor can make an immune response against the body's normal cells. Giving cyclosporine     and mycophenolate mofetil after the transplant may stop this from happening. Once the donated     stem cells begin working, the patient's immune system may see the remaining cancer cells as     not belonging in the patient's body and destroy them (called graft-versus-tumor effect).     Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost     this effect.   "
164264|NCT00003146|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     bone marrow or peripheral stem cell transplantation in treating patients with multiple     myeloma.   "
167816|NCT00024024|"     Phase I/II trial to study the effectiveness of BMS-275291 in treating patients who have     HIV-related Kaposi's sarcoma. Drugs such as BMS-275291 may stop the growth of Kaposi's     sarcoma by stopping blood flow to the tumor.   "
164265|NCT00003147|"     Phase I trial to study the effectiveness of gene therapy with the p53 gene in treating     patients who have cancer of the liver that cannot be surgically removed. Inserting the p53     gene into a person's tumor may improve the body's ability to fight liver cancer.   "
164266|NCT00003148|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myelogenous     leukemia cells.      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with     acute myelogenous leukemia that has relapsed following previous treatment.   "
164267|NCT00003149|"     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by     stimulating a person's blood cells to kill multiple myeloma cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of interleukin-12 given at     different times in treating patients with multiple myeloma.   "
164268|NCT00003150|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. It is not yet known if combination chemotherapy is more effective with or without     rituximab for non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without rituximab in treating older patients who have non-Hodgkin's lymphoma.   "
164269|NCT00003151|"     RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated     with gastric lymphoma.      PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients     with low grade gastric lymphoma that has not been previously treated.   "
164270|NCT00003152|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.     Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation     therapy and kill more cancer cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     followed by interferon alfa alone or combination chemotherapy plus radiation therapy and     peripheral stem cell transplantation in treating patients who have previously untreated stage     III or stage IV follicular non-Hodgkin's lymphoma.   "
164271|NCT00003153|"     RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with     multiple myeloma that has recurred following bone marrow transplantation.      PURPOSE: This phase II trial is studying how well giving donor white blood cells works in     treating patients with recurrent multiple myeloma who have undergone bone marrow     transplantation.   "
164272|NCT00003154|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients     with stage III or stage IV non-small cell lung cancer.   "
164273|NCT00003156|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with     recurrent or refractory cancer of the uterus.   "
164274|NCT00003157|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus chemotherapy in     treating patients who have cancer of the pancreas or stomach.   "
164275|NCT00003158|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy     consisting of carboplatin, etoposide and paclitaxel in treating patients with newly diagnosed     stage III non-small cell lung cancer.   "
164276|NCT00003159|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if surgery is more effective with or without     preoperative chemotherapy in treating non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying surgery and preoperative chemotherapy to     see how well they work compared to surgery alone in treating patients with resectable     non-small cell lung cancer.   "
164277|NCT00003160|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving the drugs in different ways may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women with stage     III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based regimens.   "
164278|NCT00003639|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells     and slow the growth of non-Hodgkin's lymphoma. It is not yet known whether combining more     than one chemotherapy drug with interferon alfa is more effective than chemotherapy alone in     treating patients with low-grade non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without interferon alfa in treating patients with low-grade non-Hodgkin's lymphoma.   "
164279|NCT00003640|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combination chemotherapy combined with transurethral resection may     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of transurethral resection plus     combination chemotherapy in treating patients who have stage II or stage III bladder cancer.   "
164280|NCT00003641|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known     whether treatment with interferon alfa is more effective than observation alone for stage II     or stage III melanoma that has been completely removed surgically.      PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how     well it works compared to observation only in treating patients with stage II or stage III     melanoma that has been completely removed by surgery.   "
164281|NCT00003642|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than one drug and combining radiation therapy with chemotherapy may kill     more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy combined with     fluorouracil and cisplatin in treating patients who have stage II or stage III bladder     cancer, and who have undergone transurethral resection.   "
164282|NCT00003643|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which regimen of combination chemotherapy may be more effective for germ cell     cancer.      PURPOSE: This randomized phase II/III trial is studying two different regimens of combination     chemotherapy and comparing how well they work in treating men with germ cell cancer.   "
164283|NCT00003644|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose     paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian     cancer.      PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see     how well they work compared to carboplatin and paclitaxel together with continued low-dose     paclitaxel in treating patients with early-stage ovarian cancer.   "
164284|NCT00003645|"     RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy     using leuprolide and flutamide may fight prostate cancer by reducing the production of     testosterone. It is not yet known whether receiving leuprolide and flutamide is more     effective than receiving no further therapy.      PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in     treating patients who have stage I or stage II prostate cancer that is at high risk of     recurrence and who have already undergone surgery.   "
164285|NCT00003646|"     RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an     immune response that will kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who     have stage III or stage IV melanoma that has not responded to previous treatment.   "
164286|NCT00003647|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the     body build an immune response that will kill tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or     without immunotherapy in treating patients who have stage III or stage IV melanoma.   "
164287|NCT00003648|"     RATIONALE: Determination of genetic markers for colorectal cancer may help doctors to     identify patients who are at risk.      PURPOSE: Genetic testing study of patients and families with a history of colorectal cancer     to identify patients who are at risk of developing colorectal cancer.   "
164288|NCT00003649|"     RATIONALE: Exposing tumor cells to the p53 gene may improve the body's ability to fight     non-small cell lung cancer.      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who     have non-small cell lung cancer that cannot be surgically removed.   "
164289|NCT00003650|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating     children who have non-Hodgkin's lymphoma.   "
164290|NCT00003652|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: This randomized phase III trial is studying different regimens of giving combination     chemotherapy together with radiation therapy and comparing how well they work in treating     patients with stage II or stage III anal cancer.   "
164291|NCT00003653|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy may     fight prostate cancer by reducing the production of androgens. It is not yet known which     androgen suppression regimen is more effective for prostate cancer.      PURPOSE: This randomized phase III trial is studying two hormone therapy regimens and     comparing them to see how well they work in treating patients with rising PSA levels     following radiation therapy for prostate cancer.   "
164292|NCT00003654|"     RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph     nodes, may improve the ability to detect the extent of disease and help plan effective     surgery for removing breast tumors.      PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to     identify the sentinel lymph node under the arm in women with stage I or stage II breast     cancer.   "
164730|NCT00005305|"     To elucidate the role of hepatitis delta virus (HDV) in the development of chronic liver     disease in patients with hemophilia.   "
164293|NCT00003656|"     RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa     may interfere with the growth of cancer cells.      PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon     alfa in treating patients who have metastatic kidney cancer.   "
164294|NCT00003657|"     The purpose of the study is to evaluate the combination of amifostine and high dose     chemotherapy with blood stem cell support. Amifostine is a druf developed to protect normal     tissues against the toxicities of chemotherapy and radiotherapy and has reduced the side     effects of chemotherapy given at conventional doses.   "
164295|NCT00003658|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining pentostatin,     cyclophosphamide, and rituximab in treating patients who have chronic lymphocytic leukemia or     other B-cell cancers that have been treated previously.   "
167972|NCT00038207|"     The goal of this clinical research study is to learn if treatment with the drug liposomal     vincristine can shrink or slow the growth of the patient's cancer. The safety of this drug     will also be studied.   "
164296|NCT00003659|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.     Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing     substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of fludarabine plus high-dose     cyclophosphamide and rituximab in treating patients who have previously untreated chronic     lymphocytic leukemia.   "
164297|NCT00003661|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Umbilical cord blood transplantation may be able to replace cells destroyed by     chemotherapy or radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and     umbilical cord blood transplantation in treating patients who have hematologic cancer.   "
164298|NCT00003662|"     RATIONALE: Umbilical cord blood transplantation may be able to replace cells destroyed by     chemotherapy or radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation in     treating patients who have hematologic cancer or other hematologic or metabolic diseases.   "
164299|NCT00003663|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Combining the monoclonal     antibody rituximab with dexamethasone may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab and dexamethasone in treating     patients with recurrent or refractory indolent non-Hodgkin's lymphoma.   "
164300|NCT00003664|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill     kidney cancer cells. Interferon alfa may interfere with the growth of cancer cells. Combining     chemotherapy with biological therapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and biological     therapy in treating patients with kidney cancer that is metastatic or cannot be removed     surgically.   "
164301|NCT00003665|"     Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients     who have stage IV melanoma. Vaccines may make the body build an immune response to kill tumor     cells.   "
164302|NCT00003666|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with     relapsed or refractory non-small cell lung cancer.   "
164303|NCT00003667|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Biological therapies use different ways to stimulate the immune     system and stop cancer cells from growing. Combining chemotherapy with biological therapy may     kill more tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy     with or without biological therapy in treating patients who have newly diagnosed high-risk     Ewing's sarcoma.   "
164304|NCT00003669|"     RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy     using arzoxifene hydrochloride may fight the endometrial cancer by blocking the use of     estrogen by the tumor cells      PURPOSE: This phase II trial is studying how well arzoxifene hydrochloride works in treating     women with recurrent, advanced, or metastatic endometrial cancer.   "
164305|NCT00003670|"     RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using     arzoxifene hydrochloride may fight ovarian or peritoneal cancer by blocking the use of     estrogen by the tumor cells.      PURPOSE: This phase II trial is studying how well arzoxifene hydrochloride works in treating     women with metastatic refractory ovarian cancer or primary peritoneal cancer.   "
164306|NCT00003671|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     children who have newly diagnosed acute lymphocytic leukemia.   "
164307|NCT00004328|"     OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic     state in a patient with pseudohypoaldosteronism.      II. Determine the effect of extracellular fluid volume and serum potassium manipulations on     exercise tolerance, cardiac function, and endurance.      III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.   "
164308|NCT00004329|"     OBJECTIVES: I. Determine the response in plasma norepinephrine concentration and plasma     glycerol to the agonist (clonidine) and the antagonist (yohimbine) of the alpha-2 adrenergic     receptor in 6 patients with regional lipoatrophy and in 6 controls.      II. Determine the full sequence of the alpha-2 adrenergic receptor structural gene in genomic     DNA from peripheral blood leukocytes.   "
164309|NCT00004330|"     OBJECTIVES:      Assess whether chronic administration of gonadotropin-releasing hormone analogues is safe and     effective for the prevention of cyclic attacks of acute porphyria in women.   "
164731|NCT00005306|"     To compare the clinical, biochemical, and histological status of Non-A, Non-B     post-transfusion hepatitis patients with that of patients who did not develop     post-transfusion hepatitis.   "
164310|NCT00004331|"     OBJECTIVES: I. Characterize enzyme defects in patients with known or suspected porphyria and     their family members.      II. Determine whether selected patients are eligible for other porphyria research protocols.      III. Provide blood, urine, and fecal samples from well characterized patients and their     family members to investigators studying the nature of specific mutations in genes for heme     biosynthetic pathway enzymes.   "
164311|NCT00004332|"     OBJECTIVES: I. Determine whether release of endogenous growth hormone (GH)-releasing hormone     is involved in GH responses to clonidine, pyridostigmine, levodopa, arginine, GH-releasing     peptide, insulin-induced hypoglycemia, and exercise in patients with acromegaly.      II. Determine whether endogenous GH-releasing hormone influences the maintenance of GH     hypersecretion.   "
164312|NCT00004333|"     OBJECTIVES:      Assess whether 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione (NTBC) at 0.6 mg/kg     per day prevents liver failure in at least 1 patient with tyrosinemia type I.   "
167973|NCT00038220|"     The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the     growth of HIV in patients infected with the virus.   "
164313|NCT00004334|"     OBJECTIVES: I. Study the relationship between dysregulation of the     hypothalamic-pituitary-adrenal (HPA) axis and disorders of mood, vegetative function, and     cognition in patients with Cushing's disease.      II. Identify subgroups of patients with Cushing's disease who differ in the presence and     severity of the depressive syndrome, and uncover HPA axis dysregulation differences among     them using corticotropin-releasing hormone, metyrapone, and dexamethasone challenge testing.   "
164314|NCT00004335|"     OBJECTIVES: I. Evaluate the sleep-entrained patterns of gonadotropin-releasing hormone (GnRH)     and sex steroid secretion in normal and hypogonadal children.      II. Examine the acute effects of sex steroids on the sleep-entrained patterns of GnRH     secretion in pubertal children and normal adults, either by stimulation of endogenous     production with pulsatile injection or by intravenous infusion of GnRH.      III. Examine the role of endogenous opioids by means of opioid receptor blockade in the sex     steroid regulation of GnRH secretion in pubertal children and normal adults.   "
164315|NCT00004336|"     OBJECTIVES:      I. Determine the mode of inheritance of nonsyndromal Mondini inner ear dysplasia, an inner     ear malformation causing deafness, vestibular dysfunction, and recurrent meningitis.   "
164316|NCT00004338|"     OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200     patients with Wilson disease.      II. Establish further the role of zinc in the prophylactic treatment of presymptomatic     patients by increasing the current cohort from 80 to at least 100 patients.      III. Establish further the role of zinc therapy in pregnant patients with Wilson disease.      IV. Establish further the role of zinc therapy in children with Wilson disease.   "
164317|NCT00004339|"     OBJECTIVES:      Evaluate the safety and efficacy of ammonium tetrathiomolybdate alone and compared with     trientine therapy as initial treatment in patients with Wilson disease presenting     neurologically.   "
164318|NCT00004340|"     OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human     growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy.      II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes     in bone formation.      III. Characterize the response to GH in cancellous bone and in growth plate cartilage in     patients with secondary hyperparathyroidism during calcitriol therapy.   "
164319|NCT00004341|"     OBJECTIVES: I. Identify the molecular defects responsible for primary immunodeficiency     disorders.      II. Explore the mutations within each syndrome to better understand the genetics of these     disorders.      III. Study the function of the Wiskott-Aldrich syndrome proteins (WASP). IV. Design methods     to identify carriers and for prenatal diagnosis. V. Explore new avenues for therapy.   "
164320|NCT00004342|"     OBJECTIVES: I. Document the clinical course of severe chronic neutropenia (SCN).      II. Monitor and assess long term safety of primary treatment in SCN patients in the United     States, Canada, Europe, and Australia.      III. Study the incidence and outcome of adverse events such as osteoporosis, splenomegaly,     cytogenetic abnormalities, myelodysplastic syndrome, and leukemia.      IV. Evaluate growth and development and hematologic parameters. V. Monitor for clinically     significant changes in primary treatment response over time.      VI. Establish a physician network to increase the understanding of SCN. VII. Establish a     demographic database to allow for future research.   "
164321|NCT00004343|"     OBJECTIVES:      I. Determine whether Cushing's syndrome and stress-induced pseudo-Cushing's syndrome can be     differentiated by evaluating endogenous corticotropin-releasing hormone activity.   "
164322|NCT00004344|"     OBJECTIVES:      Purify and characterize a testis-stimulating factor in the blood of adult volunteers who had     precocious puberty as boys.   "
164323|NCT00004345|"     OBJECTIVES: I. Examine the concentration of docosahexanoic acid (DHA) and other n-3 fatty     acids in plasma, erythrocyte, and adipose tissue in patients with various forms of retinitis     pigmentosa and Usher syndrome.      II. Determine the synthesis and catabolism of DHA from linolenic acid in these patients.      III. Determine the synthesis, absorption, and catabolism of DHA under different dietary     conditions in these patients.   "
164324|NCT00004346|"     OBJECTIVES: I. Assess the biosynthesis of cholesterol and cholestanol, and measure the     turnover of individual sterols and bile acids in patients with cerebrotendinous xanthomatosis     before and after a cholesterol- and cholestanol-free diet.      II. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of     individual sterols and bile acids in these patients before and after lovastatin and     chenodeoxycholic acid.   "
164325|NCT00004347|"     OBJECTIVES: I. Examine the intestinal absorption of dietary cholesterol in patients with     Smith-Lemli-Opitz syndrome.      II. Measure the effect of dietary cholesterol on plasma sterol composition. III. Quantify     basal cholesterol synthesis, turnover of cholesterol and 7-dehydrocholesterol, and the     effects of dietary cholesterol on these parameters.      IV. Identify fecal bile acid excretion quantitatively and qualitatively in these patients.      V. Compare the incorporation of deuterated water into plasma cholesterol,     7-dehydrocholesterol, and other intermediates, and assess the effect of dietary cholesterol     on this incorporation.   "
164326|NCT00004348|"     OBJECTIVES:      I. Characterize inheritance patterns of mutations in patients with beta-oxidation disorders.   "
164327|NCT00004350|"     OBJECTIVES:      I. Classify renal tubular defects using clinical and biochemical findings in patients with     Fanconi syndrome and cystinosis.   "
164328|NCT00004351|"     OBJECTIVES: I. Investigate phenotype and genotype correlations in patients with Smith-Magenis     syndrome (SMS) associated with del(17p11.2).      II. Clinically evaluate SMS patients with unusual deletions or duplication of proximal 17p.      III. Clinically evaluate patients with Williams syndrome with molecular characterization of     7q11.23.      IV. Perform clinical studies of Prader-Willi, Angelman, DiGeorge, and Shprintzen syndrome     patients with unique molecular findings in 15q11q13 or 22q11.2.      V. Perform genotype and phenotype correlations in Prader-Willi patients, particularly those     with loss of expression of only some of the imprinted transcripts in 15q11-q13.      VI. Evaluate putative Angelman syndrome patients who do not have classic large deletion,     uniparental disomy, or imprinting mutations, and perform molecular studies of the Angelman     gene, UBE3A, and identify mutations of this gene.      VII. Investigate phenotype and genotype correlations in patients with terminal deletions of     chromosome 1p.   "
164329|NCT00004353|"     OBJECTIVES: I. Study the metabolism of pyruvate and related problems in patients with lactic     acidemia.      II. Define the nature of the metabolic defect.   "
164330|NCT00004354|"     OBJECTIVES: I. Determine the prevalence of glucocorticoid-remediable aldosteronism (GRA) in     various hypertensive populations and screen at risk members of GRA pedigrees.      II. Investigate other factors regulating blood pressure in GRA (environmental, genetically     determined factors).      III. Investigate renal and hormonal mechanisms regulating potassium homeostasis in GRA.      IV. Describe clinical phenotype of GRA patients. V. Prospectively screen GRA-affected     patients with MRI angiography for intracranial aneurysm.   "
164331|NCT00004356|"     OBJECTIVES: I. Determine basal and postmethionine plasma homocysteine in patients with     premature vascular disease, cystathionine beta-synthase (CBS) or methylenetitrahydrofolate     reductase (MTHFR) deficiency, and in obligate heterozygotes for CBS or MTHFR.      II. Determine whole-body homocysteine metabolic rates with isotopically-labeled methionine.   "
164332|NCT00004357|"     Juvenile dermatomyositis (JDM) is a connective tissue disease that causes skin rash and weak     muscles in children. The purpose of this study is to measure the absorption of oral     prednisolone and intravenous (IV) methylprednisolone and to determine levels of disease     activity indicators in the blood. These levels will be compared to see if there are patterns     specific to active and less active JDM.   "
164333|NCT00004696|"     OBJECTIVES: I. Compare nonmechanically ventilated infants who receive morphine     postoperatively as intermittent intravenous bolus doses or as a continuous intravenous     infusion targeted to reach a steady-state concentration.      II. Assess ventilation (blood gases, continuous oximetry, and CO2 response curves) and     analgesia (infant pain score) between the two treatment groups of infants.      III. Compare ventilation parameters (blood gases, CO2 response curves, and time to wean from     assisted mechanical ventilation) in cyanotic and acyanotic infants after thoracotomies.   "
164334|NCT00004697|"     OBJECTIVES:      I. Determine whether intravenous choline supplementation will reverse the hepatic steatosis     and improve liver function in patients who receive long term total parenteral nutrition.   "
164335|NCT00004699|"     OBJECTIVES:      I. Determine the dose of recombinant human insulin-like growth factor I that minimizes or     decreases the need for exogenous glucose support without causing hypoglycemia.   "
164336|NCT00004700|"     OBJECTIVES:      Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I     in children with hyperinsulinism.   "
164337|NCT00004705|"     OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the     metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic     fibrosis.      II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic     fibrosis.   "
164338|NCT00004727|"     The African-American Antiplatelet Stroke Prevention Study is designed to prevent recurrent     strokes by administration of aspirin or ticlopidine. The study also provides community     information on reducing risk of stroke and recognizing the symptoms of stroke. The study     involves more than 50 participating hospitals located throughout the United States. Study     medication is provided free of charge, and a transportation stipend is available for those in     need.   "
164339|NCT00004728|"     The purpose of this study is to determine whether aspirin or warfarin is more effective in     preventing stroke in patients with intracranial stenosis.   "
164340|NCT00004729|"     Twenty to thirty percent of children with epilepsy continue to suffer from seizures, even     when treated with currently available anticonvulsant medications. Children with     Lennox-Gastaut Syndrome (LGS) are particularly handicapped by atonic-myoclonic seizures.     Preliminary data suggest that even when other medications have failed, these seizures may     respond rapidly and dramatically to a high-fat-low-carbohydrate ketogenic diet. The purpose     of the study is to assess if the classic ketogenic diet is efficacious in reducing seizure     frequency, medication toxicity, and improves quality of life.   "
164341|NCT00004730|"     The purpose of the study is to determine whether magnesium sulfate, given within 8 hours of a     moderate or severe traumatic brain injury improves survival, decreases the number of people     developing seizures, improves the survivors' mental and psychological functioning, including     the ability to return to daily life, live independently, and return to work or school.   "
164342|NCT00004731|"     The purpose of this study is to compare the effects of varying dosage of coenzyme Q10 (CoQ10)     versus a placebo in the treatment of Parkinson's disease (PD) in patients with early,     untreated PD.   "
164343|NCT00004732|"     The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is     to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the     traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment     of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA     (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in     those patients who have not had any symptoms within the past 6 months (asymptomatic).   "
164344|NCT00004733|"     The ELLDOPA study is a controlled clinical trial in patients with newly diagnosed PD to     determine the optimal timing and dosing with levodopa (Sinemet or its generic equivalents).   "
164374|NCT00004779|"     OBJECTIVES: I. Assess the safety and efficacy of gene transfer into the nasal epithelium     using Ad5-CB-CFTR, an E1-deleted adenovirus vector containing the cystic fibrosis     transmembrane conductance regulator gene, in patients with cystic fibrosis (CF).      II. Determine whether ion transport abnormalities in CF airway cells can be corrected.   "
164345|NCT00004734|"     A stroke occurs when part of the brain is damaged from lack of normal blood supply. This may     result in difficulty with feeling, speech, muscle strength or coordination, movement,     thinking, or other brain functions. Having a stroke increases the risk of another stroke     occurring in the future. Higher blood levels of a natural chemical known as homocysteine may     contribute to hardening of the arteries in the brain or heart and increase the risk of stroke     or heart attack. Folic acid, vitamin B6 (pyridoxine), and vitamin B12 (cyanocobalamin) may     lower blood levels of homocysteine and reduce the risk of having another stroke or a heart     attack.   "
164356|NCT00004754|"     OBJECTIVES: I. Provide epoprostenol (Flolan, prostaglandin I2) by chronic infusion to     patients with severe primary pulmonary hypertension for whom no alternative therapy is     available.      II. Obtain additional safety information on continuous infusion epoprostenol. III. Obtain     additional information on economic resource health consumption.   "
164346|NCT00004735|"     The purpose of this study is to determine the number of newly formed CD4 cells in children     who have taken anti-HIV drugs. The study will also evaluate the effectiveness of the new CD4     cells in producing an immune response to hepatitis A and tetanus toxoid vaccination.      Study hypothesis: 1) Immunologic reconstitution of individuals who have less than 15% CD4     cells may or may not be associated with functional activity. 2) The functional immunologic     responses to recall and newly experienced antigens may be different. 3) The functional     responses to antigens delivered in vaccine format may be a function of CD4 level, viral load,     or both.   "
164347|NCT00004736|"     The purpose of this study is to see if a type of anti-HIV therapy called HAART is effective     in lowering levels of HIV and boosting the immune system in HIV-infected patients with     tuberculosis (TB).      HIV-infected patients with TB have higher levels of HIV and lower CD4 cell counts (cells in     the body that fight infection) than HIV-infected patients without TB. HAART has been     effective in reducing HIV levels and increasing CD4 cells in patients without TB. However,     its effects in HIV-infected patients with TB are unknown.   "
164348|NCT00004738|"     The purpose of this study is to better understand the genetic factors related to the Chiari I     malformation. In people with this abnormality, the lower part of the skull is smaller than     normal. As a result, the lowest part of the brain, called the cerebellar tonsils, protrudes     out of the hole at the bottom of the skull into the spinal canal. This study will try to     discover the location of the genes responsible for the malformation.      Candidates for this study are: 1) Patients with Chiari I malformation who also have a family     member with the abnormality or a family member with syringomyelia (a cyst in the spinal cord     that is often associated with the Chiari I malformation). 2) Family members of patients with     the Chiari I malformation.      Participants will have a medical history and physical and neurologic examinations. They will     undergo magnetic resonance imaging (MRI) of the brain and cervical (neck) spinal cord to     measure the size of the head and determine the presence of the Chiari I malformation and     syringomyelia. A small blood sample (about 2 tablespoons) will be drawn for DNA studies     relating to the Chiari I malformation.   "
164349|NCT00004739|"     The use of protease inhibitors is increasing in HIV-infected children because this treatment     has resulted in improved body weight, improved immune status and less hospitalizations.     However, recent reports suggest that these drugs may also be associated with some negative     side-effects, specifically a syndrome of diabetes and fat redistribution. Development of the     fat redistribution/diabetes syndrome has recently been reported in HIV-infected children, as     well as in adults. Diabetes is associated with complications such as increased heart disease,     eye disease and loss of kidney function. Thus development of diabetes is a significant     problem which could outweigh the benefits obtained by treating patients with protease     inhibitors. One major cause of diabetes is lack of normal response to insulin (insulin     resistance). Insulin resistance tends to be worse in family members where one or more parent     has diabetes, and is also worse in certain ethnic groups. The first major purpose of our     study is measure insulin resistance in HIV-infected children who do not take protease     inhibitors, and compare our findings to those from patients who are treated with protease     inhibitors. We will also follow patients newly treated with protease inhibitors for two years     to evaluate changes in insulin sensitivity. These results will be correlated with each     patient's family history of diabetes and with ethnicity, and should help us better predict     which children are at risk for development of diabetes from protease inhibitor therapy.     Children with HIV infection often have problems with gaining enough weight and with poor     linear growth (height). One likely reason for this is the way their bodies use and store     protein. The second purpose of our study is measure protein turnover and to correlate our     findings with growth data. We also plan to study the effects of protease inhibitor therapy on     protein turnover. We believe that these studies will provide knowledge to help clinicians     formulate recommendations for nutritional and medical therapy.   "
164350|NCT00004740|"     OBJECTIVES: I. Recruit 300 injection drug users with positive tuberculin skin tests who are     candidates for isoniazid chemoprophylaxis into a trial of several interventions to enhance     adherence to preventive therapy.      II. Compare the effectiveness of self-administered isoniazid chemoprophylaxis supplemented     with peer education and support groups versus directly observed preventive therapy delivered     by a licensed nurse versus self-administered therapy with standard clinic follow-up and     education. Outcome measures are adherence to prescribed doses of medication and the     proportion of patients who complete therapy.      III. Compare the impact of monetary incentives on therapy adherence by random assignment to     immediate vs. deferred financial incentive.      IV. Assess attitudes, knowledge, and beliefs about tuberculosis and preventive therapy in     these patients and determine the association of these factors with demographic, social, and     clinical characteristics.      V. Assess attitudes and beliefs about tuberculosis susceptibility, seriousness, benefits of     preventive therapy, barriers to therapy, and self-efficacy as predictors of health-related     behaviors as measured by adherence with therapy, and determine the impact of the assigned     interventions on these attitudes and beliefs.   "
164351|NCT00004744|"     OBJECTIVES: I. Determine whether high-dose intravenous immune globulin (IVIG) is more     effective than placebo in restoring neurologic function (muscle strength) in patients with     multiple sclerosis.      II. Determine the time to recovery following IVIG.   "
164352|NCT00004747|"     OBJECTIVES: I. Assess the efficacy of monthly intravenous mucoid exopolysaccharide     Pseudomonas aeruginosa immune globulin (MEP IGIV) given over 1 year in reducing the frequency     of acute pulmonary exacerbation in patients with cystic fibrosis, mild to moderate pulmonary     disease, and mucoid P. aeruginosa colonization.      II. Assess the effect of MEP IGIV on FEV1, sputum density of mucoid P. aeruginosa, and the     quality of life in these patients.      III. Assess the safety of monthly MEP IGIV. IV. Assess population-based MEP IGIV     pharmacokinetics during chronic therapy.   "
164353|NCT00004748|"     OBJECTIVES:      I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus     colchicine and ursodiol in patients with primary biliary cirrhosis (PBC).      II. Determine the optimum dose and duration of MTX treatment.      III. Investigate the role of fibrogenic cytokines (FC) in PBC pathogenesis and the effect of     treatment on FC production.   "
164354|NCT00004751|"     OBJECTIVES:      I. Assess the efficacy and safety of selective dorsal rhizotomy and physiotherapy compared     with physiotherapy alone in improving gross motor function and reducing spasticity in     children with spastic diplegia.   "
164355|NCT00004753|"     OBJECTIVES: I. Correlate clinical outcome with cerebral glucose metabolism in patients with     Huntington's disease (HD) and their at-risk relatives.      II. Evaluate the efficacy of cerebral glucose metabolism in observing the pathophysiologic     development of HD, monitoring responses to experimental therapy, and predicting HD genotype.      III. Identify, define, and describe the natural history of pathophysiologic lesions in HD.      IV. Characterize the genotypic and phenotypic expression of the HD gene.   "
164357|NCT00004755|"     OBJECTIVE:      Compare the efficacy and side effects of allopurinol versus glucantime versus     allopurinol/glucantime in patients in Brazil with cutaneous leishmaniasis.   "
164358|NCT00004756|"     OBJECTIVES:      I. Evaluate an educational program that has been pretested for cultural appropriateness and     literacy requirements in patients with systemic lupus erythematosus (SLE).      II. Assess the impact of this educational program on patients with SLE, with an emphasis on     recognizing cardinal symptoms, coping with fatigue, regulating medications, and communicating     with the physician.   "
164359|NCT00004757|"     OBJECTIVES: I. Determine whether acyclovir (ACV) oral suspension suppresses recurrent skin     lesions and improves neurologic outcome in neonates with localized herpes simplex virus type     2 infection when administered for 6 months in a placebo-controlled study.      II. Determine whether the prevention of recurrent skin lesions reduces long-term neurologic     morbidity.      III. Determine whether resistant disease develops after oral ACV therapy. IV. Evaluate the     natural history of recurrent skin lesions. V. Measure any adverse effects and laboratory     abnormalities associated with long-term oral ACV therapy in infants and young children.   "
164360|NCT00004758|"     OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of     cortical abnormality versus multiple drug therapy in children with infantile spasms     refractory to standard therapy.      II. Assess how infantile spasms interfere with development and whether this is partially     reversible.      III. Determine the predictors of good surgical outcome and whether surgery permanently     controls seizures and improves development.   "
164361|NCT00004759|"     OBJECTIVES:      I. Compare the efficacy and safety of 24- versus 48-hour infusion of methylprednisolone     (MePRDL) versus tirilazad for patients with acute spinal cord injury.      II. Compare neurologic recovery following 24- and 48-hour MePRDL infusions.   "
164362|NCT00004760|"     OBJECTIVES:      I. Compare the benefit of exercise versus usual care (no exercise) on impairments and     functional limitations in patients with Parkinson disease.   "
164363|NCT00004761|"     OBJECTIVES: I. Develop a large roster of well-characterized patients with various forms of     inherited and acquired epidermolysis bullosa (EB).      II. Generate a large data bank of clinical, historical, and genetic information concerning     these patients.      III. Accumulate donated tissue specimens, including selected cells and DNA, from selected     patient subsets for the establishment of permanent tissue cell banks.      IV. Promote and facilitate research in EB.   "
164364|NCT00004762|"     OBJECTIVES:      I. Evaluate the effects of cladribine (2-chlorodeoxyadenosine; 2-CdA) on biochemical,     radiologic, and histologic parameters in patients with early stage primary sclerosing     cholangitis.   "
164365|NCT00004763|"     OBJECTIVES:      I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and     leuprolide/oral contraceptive therapy in the management of patients with ovarian     hyperandrogenism.   "
164366|NCT00004767|"     OBJECTIVES:      I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium     phenylacetate, and dietary intervention in patients with urea cycle disorders.   "
164367|NCT00004769|"     OBJECTIVES: I. Examine the interrelationships between muscle wasting (phenotype), the degree     of myotonic dystrophy (DM) gene expression (genotype) in patients with DM.      II. Characterize the insulin resistance in these patients. III. Assess the glucose uptake in     the leg and forearm tissues of these patients.      IV. Determine the stability of the DM gene lesion in muscles over a 5-10 year period.   "
164368|NCT00004770|"     OBJECTIVES:      I. Assess the efficacy of thioctic acid in treating a single patient with mitochondrial     myopathy.   "
164369|NCT00004771|"     OBJECTIVES:      I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with     testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron     disease.   "
164370|NCT00004772|"     OBJECTIVES:      I. Compare the response of previously untreated patients with chronic inflammatory     demyelinating polyneuropathy to intravenous immune globulin vs. placebo.   "
164371|NCT00004773|"     OBJECTIVES: I. Evaluate electrocardiographic parameters, including QT and PR intervals and     QRS morphology/duration, across clinical stages in patients with Rett syndrome.      II. Characterize abnormalities of cardiac conduction and repolarization. III. Assess     arrhythmias, heart rate variability, and autonomic nervous system function in these patients     using 24-hour Holter monitoring.      IV. Record events believed to represent seizures with video, electroencephalogram (EEG), and     polygraph monitoring in patients who have more than 1 clinical seizure every 5 days.      V. Characterize these events with respect to clinical manifestations, EEG correlates, and     other physiologic data.      VI. Determine the frequency of seizures vs. events without electrographic correlates in these     patients.      VII. Determine whether Rett syndrome patients have characteristic or unique types of seizures     and/or an epileptic syndrome.   "
164372|NCT00004776|"     OBJECTIVES:      I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut     syndrome.   "
164373|NCT00004778|"     OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of     initial lung disease and occurrence of chronic lung disease when given antenatally to women     with threatened premature delivery.      II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of     chronic lung disease.      III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after     birth influences the severity of lung disease and the development of chronic lung disease.   "
164375|NCT00004781|"     OBJECTIVES: I. Evaluate the development of oral manifestations of human immunodeficiency     virus infection in relationship to the onset of immunologic alterations and systemic symptoms     in different risk groups: gay/bisexual men, male intravenous drug users, and female     intravenous drug users.      II. Evaluate the immune and inflammatory response to periodontal and other microbial     pathogens.      III. Evaluate the bacterial species infecting the oral cavity in patients in these risk     groups.   "
164376|NCT00004784|"     OBJECTIVES: I. Compare the effects of ursodiol (ursodeoxycholic acid), with and without     methotrexate, on pruritus, incapacitation index, and serum markers of activity and severity     in patients with primary biliary cirrhosis.      II. Compare the effects of these regimens on the development of ascites, encephalopathy,     varices (or bleeding from pre-existing varices), histologic liver changes, transplantation,     and survival.      III. Compare the toxicity and safety of each regimen.   "
167974|NCT00038233|"     The objective of this protocol is to assess therapeutic activity of thalidomide in previously     untreated patients with asymptomatic multiple myeloma.   "
164377|NCT00004785|"     OBJECTIVES: I. Compare the efficacy of dexamethasone (DM) vs. DM/methylprednisolone treatment     vs. placebo, initiated within the first month of life, on long-term pulmonary and     developmental outcomes in premature infants with evolving bronchopulmonary dysplasia.      II. Compare the toxicities of these treatments. III. Assess treatment effects on adrenal     function.   "
164378|NCT00004786|"     OBJECTIVES:      I. Evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with     Raynaud's phenomenon secondary to systemic sclerosis.   "
164379|NCT00004787|"     OBJECTIVES: I. Assess the efficacy of recombinant human granulocyte colony-stimulating factor     (G-CSF) in raising the absolute neutrophil count, platelet count, and hemoglobin level in     patients with inherited bone marrow failure syndromes.      II. Assess the efficacy of a reduced maintenance dose in patients who respond to daily G-CSF.      III. Assess the toxic effects of G-CSF in these patients. IV. Measure bone marrow progenitor     colonies before and after G-CSF. V. Measure CD34-positive cells in marrow and blood before     and after G-CSF using flow cytometry and immunohistochemistry.   "
164380|NCT00004788|"     OBJECTIVES: I. Determine whether differences in dietary habits are associated with disease     activity in patients with acute intermittent porphyria.      II. Determine whether premenstrual porphyria attacks are associated with increased luteal     phase energy requirements.      III. Determine whether energy requirements are higher than intakes in men with unexplained     frequent porphyria attacks.      IV. Assess the nutritional status of women with acute intermittent porphyria using a     comprehensive series of laboratory methods, including zinc and pyridoxine status.      V. Determine whether the frequency of disease exacerbations decreases when dietary and     nutritional abnormalities are corrected in these patients.      VI. Evaluate the safety and efficacy of a parenteral nutrition regimen for patients with     acute porphyria attacks.   "
164381|NCT00004789|"     OBJECTIVES: I. Evaluate the efficacy and safety of heme arginate in the treatment of 20     patients with acute attacks of porphyria.      II. Evaluate the efficacy and safety of heme arginate in preventing frequent exacerbations of     acute porphyria in up to 15 patients.      III. Estimate the lowest effective dose of heme arginate (0.3, 1.0, or 3.0 mg/kg) in reducing     porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission.      IV. Evaluate the safety and efficacy of tin mesoporphyrin used in combination with heme     arginate in reducing porphyrin precursors in 12 stable patients with acute intermittent     porphyria in remission.   "
164382|NCT00004791|"     OBJECTIVES: I. Characterize the nutritional and metabolic profile of children and adolescents     with epidermolysis bullosa.      II. Determine patterns of body composition in these patients. III. Determine the energy     requirements of these patients by measuring resting energy expenditure.      IV. Assess protein nutrition by measuring lean body mass.   "
164383|NCT00004793|"     OBJECTIVES: I. Evaluate the effect of bromocriptine on luteinizing hormone (LH) secretion by     suppression of prolactin and stimulation of dopaminergic receptors in early pubertal boys and     girls.      II. Evaluate the effect of baclofen on LH secretion by stimulation of gamma-aminobutyric acid     receptors in early pubertal boys and girls.   "
164384|NCT00004794|"     OBJECTIVES: I. Evaluate the safety and efficacy of intravenous cidofovir in patients with     small peripheral cytomegalovirus retinitis.      II. Obtain safety and efficacy data related to different dosages of cidofovir.   "
164385|NCT00004795|"     OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone (GL701)     in women with prednisone-dependent systemic lupus erythematosus.      II. Describe the pharmacokinetics of GL701.   "
164386|NCT00004796|"     OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in     patients with subclinical hepatic encephalopathy.      II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological     tests.      III. Assess which elements of the neuropsychological test battery show the response to     lactulose.   "
164387|NCT00004797|"     OBJECTIVES: I. Evaluate the efficacy and tolerability of fructose administered every 6 hours     for up to 72 hours to patients in active sickle cell crisis.      II. Obtain tolerability information in selected patients treated with fructose for more than     72 hours.   "
164388|NCT00004799|"     OBJECTIVES: I. Compare the safety and efficacy of acellular 2-component vs. acellular     multicomponent vs. whole-cell pertussis vaccine vs. placebo in infants living in Sweden.      II. Compare the relative protection of each vaccine against atypical or subclinical pertussis     infection.      III. Analyze possible laboratory correlates to vaccine protection.   "
164389|NCT00004800|"     OBJECTIVES: I. Compare the efficacy of 2 acellular pertussis vaccines vs. whole-cell     pertussis vaccine vs. placebo in infants living in Italy.      II. Compare the relative protection of each of the acellular vaccines vs. the whole-cell     vaccine vs. laboratory-confirmed pertussis.      III. Assess the relative efficacy of the acellular vaccines with respect to one another.      IV. Assess the immunogenicity of acellular vs. whole-cell vaccines in the study population.      V. Compare the frequency of adverse events with each vaccine. VI. Compare the frequency of     adverse events attributable to the pertussis component in each of the 3 vaccines.      VII. Assess alternative laboratory diagnostic techniques for pertussis in estimating vaccine     efficacy, i.e., mucosal immune response, DNA probes, or antibody response to other components     of the organism.      VIII. Assess the relative efficacy estimates of each vaccine, using clinical criteria to     compare the relative incidence rates in each vaccine group.   "
164392|NCT00004804|"     OBJECTIVES: I. Determine whether the initial response to interferon alfa (IFN-A) can be     increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis     C.      II. Determine whether patients who had normalized alanine aminotransferase (ALT) levels can     maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 1.5 MU.   "
164393|NCT00004805|"     OBJECTIVES: I. Describe the psychosocial response of parents and caretakers who learn     cardiopulmonary resuscitation (CPR) techniques for infants at high risk for respiratory or     cardiac arrest.      II. Compare the effect of 4 methods of CPR instruction on psychosocial response.      III. Evaluate a psychological intervention based on social support theory designed to offset     the potential adverse psychological outcomes of CPR instruction.      IV. Evaluate a self-paced CPR learning module using the principles of adult learning theory.      V. Document the level of CPR knowledge and skill retention over time. VI. Document the     frequency of CPR and its outcome following a witnessed respiratory or cardiac arrest.   "
164395|NCT00004807|"     OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome     (RS).      II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of     cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine,     while continuing supportive care to modify seizures, respiratory abnormalities, and motor     disturbances, and improve nutrition, behavior, and learning.      IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence     neurologic recovery.   "
164396|NCT00004808|"     OBJECTIVES: I. Identify a preferred oral fluconazole dose regimen for patients with non-acute     histoplasmosis or blastomycosis, or ulcerocutaneous or deep sporotrichosis.      II. Study the safety and efficacy of fluconazole in these patients.   "
164397|NCT00004809|"     OBJECTIVES:      I. Develop an approach for treating patients with homozygous familial hypercholesterolemia     using gene therapy with autologous hepatocytes transduced with a normal low-density     lipoprotein receptor gene.   "
164398|NCT00004810|"     OBJECTIVES:      I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to     moderately severe ulcerative colitis.   "
164399|NCT00004811|"     OBJECTIVES: I. Evaluate the tolerance of patients with blastomycosis, histoplasmosis, and     sporotrichosis to different doses of itraconazole (R51,211).      II. Determine levels of itraconazole in serum and other body fluids. III. Assess the course     of illness during itraconazole therapy. IV. Determine the dosage of itraconazole that is safe     and well tolerated by 80%-90% of patients and estimate the potential of this dosage for use     in future comparative trials.   "
164400|NCT00004812|"     OBJECTIVES: I. Assess the ability of patients with and without sensorimotor loss below the     thoracic spinal cord injury to execute coordinated whole-limb synergies sufficient for     walking with full or partial weight support.      II. Promote weight bearing, balance, and reciprocal leg movement in these patients.      III. Elicit synchronized motor output within and between limbs in these patients.   "
164401|NCT00004814|"     OBJECTIVES:      I. Compare tolerance to and therapeutic impact of copolymer 1, a mixture of synthetic     polypeptides, with placebo in patients with relapsing-remitting multiple sclerosis.   "
164402|NCT00004815|"     OBJECTIVES:      I. Assess the safety and efficacy of recombinant human insulin-like growth factor 1 in a     patient with Werner's syndrome and osteoporosis.   "
164403|NCT00004816|"     OBJECTIVES: I. Evaluate the safety and immunogenicity of single and multiple doses of M-T412,     a chimeric murine-human anti-CD4 monoclonal antibody, in patients with multiple sclerosis.      II. Evaluate the pharmacokinetics of M-T412. III. Obtain preliminary data on the clinical     response to M-T412.   "
164404|NCT00004817|"     OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will     reduce the risk of developing seizures as a result of the head injury.      II. Determine the safety of valproate, the appropriate dose, and the effect valproate may     have on the recovery of the brain's ability to compute numbers, solve problems, remember     information, and control the movement of limbs after head injury.   "
164405|NCT00004825|"     OBJECTIVES: I. Confirm the inhibitory effect of recombinant human insulin-like growth factor     I (IGF-I) on insulin secretion in children with hyperinsulinism.      II. Define the effects of short term IGF-I therapy on postprandial blood sugar levels in this     patient population.      III. Characterize the effects of short term IGF-I therapy on fasting behavior, and other     insulin dependent parameters, in this patient population.   "
164406|NCT00004826|"     OBJECTIVES: I. Determine the efficacy and tolerability of clozapine in ameliorating psychosis     in patients with idiopathic Parkinson's disease (PD).      II. Determine the adverse effects of clozapine on motor function in this patient population.      III. Determine the safety of clozapine in psychotic PD patients taking multiple anti-PD     medications.      IV. Describe the phenomenology of drug induced psychosis in PD.   "
164407|NCT00004827|"     OBJECTIVES:      I. Evaluate the potential of nutritional docosahexaenoic acid (DHA) supplementation to     normalize the level of DHA in red blood cells, and to retard the progression of visual     function loss in patients with early stage X-linked retinitis pigmentosa.   "
164408|NCT00004828|"     OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in     children undergoing the modified Fontan procedure.      II. Determine the liothyronine supplementation dose that counters the fall in serum     liothyronine concentrations and provides the greatest potential myocardial benefit after the     modified Fontan procedure.      III. Evaluate the potential toxicity of exogenous liothyronine administered in children     undergoing a modified Fontan procedure.   "
164409|NCT00004829|"     OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic     fibrosis who are chronically colonized with Pseudomonas aeruginosa.      II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency     different from the placebo group and whether the emergence of resistance is associated with a     lack of clinical response.   "
164410|NCT00004831|"     OBJECTIVES:      I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing     photosensitivity in patients with erythropoietic protoporphyria.   "
164412|NCT00004833|"     OBJECTIVES:      I. Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing     morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome.      II. Compare the potential risks, in terms of treatment related side effects and adverse     clinical outcome, between these two treatment modalities.   "
164413|NCT00004834|"     OBJECTIVES:      I. Determine which treatment is most effective for patients with panic disorder:     cognitive-behavioral therapy (CBT) plus imipramine (IMI), CBT plus placebo, CBT alone, IMI     alone, or placebo alone.   "
164414|NCT00004838|"     OBJECTIVES:      Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA)     plus standard treatment to those receiving standard treatment only.   "
164415|NCT00004840|"     OBJECTIVES:      I. Assess the efficacy and safety of antenatal administration of thyrotropin-releasing     hormone to women in premature labor to improve pulmonary outcomes in preterm infants.   "
164416|NCT00004842|"     OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary     sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to     ursodeoxycholic acid.      II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating     the feasibility of a long-term randomized trial.   "
164420|NCT00004846|"     This study will evaluate the accuracy of an experimental test method called nucleic acid     amplification technology (NAT) in detecting human immunodeficiency virus (HIV) and hepatitis     C virus (HCV). This test amplifies the nucleic acid in a virus more than a million-fold,     allowing early detection of minute quantities of virus in the blood.      Blood donors to the National Institutes of Health's Department of Transfusion Medicine (blood     bank) will have their blood screened with transcription mediated amplification, a type of NAT     test. Donors whose blood is found positive for HIV or HCV by NAT testing will be notified and     asked to participate in this study. Those who agree will provide a blood sample about once a     week for 3 months. The samples will be tested with additional assays to detect evidence of     HIV or HCV infection. If the test results are confirmed positive, no more blood samples will     be collected. The results of the tests and their significance will be explained to     participants.      It is anticipated that NAT screening will reduce the risk of transfusion-related HIV     transmission from the current 1 in 650,000 to 1 in a million and the risk of HCV transmission     from the current 1 in 100,000 to 1 in 350,000. It is possible that these tests will     completely eliminate the risk of transmitting these diseases through blood transfusion.   "
164422|NCT00004848|"     This protocol represents a continuation of a series of prospective studies to define the     incidence and etiology of transfusion-associated hepatitis (TAH) and to examine the impact on     TAH of various modifications in the selection of blood donors.      The primary goal of the study will be to determine TAH incidence after the institution of a     variety of interventive measures to exclude hepatitis and AIDS virus carriers: including     surrogate assays (ALT, anti-HBc), a specific assay for the hepatitis C virus (HCV), a     specific assay for the human immunodeficiency virus (HIV) and intensified donor questioning     for high-risk behavior patterns. There is high probability that the exclusion of donors at     high risk for AIDS transmission will also exclude donors at high risk for hepatitis     transmission.      Incidence data obtained in the study will be enhanced by the simultaneous follow-up of a     control population undergoing identical surgical procedures, but receiving no blood or only     autologous blood. This control population, made possible by the recent dramatic increase in     the amount of autologous blood utilized, will allow for a clear distinction between     transfusion-associated hepatitis and that due to nosocomial transmission or other background     causes of hepatocellular inflammation in cardiac surgery patients.   "
164433|NCT00004860|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in     treating elderly patients who have metastatic colorectal cancer.   "
164434|NCT00004861|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug or giving drugs in different ways may     kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine with or     without CI-994 in treating patients who have advanced pancreatic cancer.   "
164732|NCT00005307|"     To quantify the role of drugs and other factors in the etiology of agranulocytosis and     aplastic anemia.   "
164423|NCT00004850|"     This study will evaluate hepatitis C virus (HCV) infection in blood donors who test positive     for antibodies to this virus. Most HCV-infected people do not become ill and are not aware     that they have hepatitis or have had it in the past. Some infected people recover completely,     whereas others remain chronically infected. The study will try to define infectivity of     anti-HCV positive individuals, routes of transmission of the virus, and the number of     HCV-infected persons who have evidence of liver disease.      Blood donors at the NIH Clinical Center or the Central Maryland Chapter of the American Red     Cross who test positive for HCV may be eligible for this study. Participants will have a     physical examination and history, including questions about socioeconomic status and current     sexual practices. They will have 100 milliliters (ml) (6 tablespoons) of blood drawn at the     first visit and 50 ml (3 tablespoons) drawn 3, 6, 9 and 12 months after the initial visit.     Some participants may undergo plasmapheresis, a procedure for collecting additional plasma     (the liquid portion of the blood). For this procedure, whole blood is collected through a     needle placed in an arm vein. The blood circulates through a machine that separates it into     its components. The plasma is then removed, and the red and white cells and platelets are     returned to the body, either through the same needle used to draw the blood or through a     second needle placed in the other arm. In some individuals, other body fluids (saliva, urine     or semen) may also be collected.      Participants may be asked to bring their household contacts and sexual partners to NIH for     interview and blood testing for evidence of HCV infection and liver disease. Although this is     not required for participation in the study, it would provide additional valuable     information.      Participants found to have chronic viral infection will be seen more often and will provide     additional blood samples for routine medical care. Further medical evaluation may include     X-rays or liver scans and referral to a specialist for additional tests or therapy.      Ten people in this study will be recruited to participate in a secondary investigation to     analyze changes in the level of HCV and the immune response to it, and to relate these     changes to the degree of liver damage. In addition to blood collected for the primary study,     participants in this investigation will have an additional 50 ml (3 tablespoons) of blood     drawn from an arm vein every week for 10 weeks to measure levels of virus, ALT (a liver     enzyme), and immune response.   "
164424|NCT00004851|"     To generate a library of genes that reflect the entirety of antibody responses to hepatitis C     virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose     viral quasispecies has been extensively characterized. In addition to characterizing the     sequential events in antibody formation and their relationship to the changing pattern of     viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which     they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress     viral replication and to translate this to therapeutic and preventive modalities.   "
164425|NCT00004852|"     The purpose of this study is to look at the safety and effectiveness of receiving lamivudine     (3TC) once a day versus twice a day as part of an anti-HIV drug combination.   "
164426|NCT00004853|"     Filgrastim (granulocyte colony-stimulating factor), which is administered by daily     subcutaneous injection after cytotoxic chemotherapy, shortens the duration of     chemotherapy-induced neutropenia and lowers the risk of infection. In children treated with     dose-intensive chemotherapy, filgrastim reduces the duration of severe neutropenia and, as a     result, has become a standard component of the treatment regimen. Filgrastim-SD/01 (AMGEN),     which is produced by PEGylation of the amino-terminus of filgrastim, is a sustained duration     form of granulocyte colony-stimulating factor. In phase I and phase II trials in adults, a     single dose of Filgrastim-SD/01 appears to be equivalent to daily dosing of filgrastim in     enhancing neutrophil recovery and has a comparable adverse event profile.      Dose-intensive vincristine/cyclophosphamide/doxorubicin (VDoxC) alternating with     ifosfamide/etoposide (IE) has become standard therapy for children and adolescents with     Ewing's sarcoma and other sarcomas treated at the POB/NCI and other cancer centers within the     US. Supportive care measures used in children who are treated with this regimen include mesna     to prevent oxazaphosphorine urotoxicity, dexrazoxane to reduce doxorubicin cardiotoxicity,     and filgrastim to shorten the duration of neutropenia. The purpose of this randomized open     label trial is to compare the tolerance, toxicity, and therapeutic effects of     Filgrastim-SD/01 given as a single injection after chemotherapy to daily subcutaneous     filgrastim in patients with newly diagnosed sarcoma. The pharmacokinetics of Filgrastim-SD/01     will also be compared to the pharmacokinetics of filgrastim. This trial will also be a     platform for performing biological studies of these tumors and for detailed cardiac studies.     High-risk patients who are treated on this front line trial and respond will also be     candidates for a planned transplant protocol. A total of 34 patients (17 patients per     treatment arm) will be entered onto the trial.   "
164427|NCT00004854|"     We would like to see if using Carvedilol in adjunct with Ace inhibitors will increase     ejection fraction of the heart under echo. All interpretation of data will be sent to Boston     Children's Hospital to be reviewed, which is the primary research center in this study. There     are 5 hospitals participating in this study. The population targeted are children with     moderate heart failure and must be on Ace inhibitors at the time of enrollment. Our outcome     after placing them on Carvedilol is to change their ejection fraction on echo. The patients     will be seen every 1-2 weeks, while we will titrate their medication to a maintenance dose.     Secondary outcome is to increase quality of life, exercise tolerance and decrease their     symptom scores as noted on their questionnaires.   "
164428|NCT00004855|"     This study will compare an anti-HIV drug combination of protease inhibitor plus a     nonnucleoside reverse transcriptase inhibitor (NNRTI) to one that includes three nucleoside     reverse transcriptase inhibitors (NRTIs) plus an NNRTI. NNRTIs, NRTIs, and protease     inhibitors are all types of anti-HIV drugs that block the virus in some way.      This study will try to find out if a treatment regimen containing a protease inhibitor plus     an NNRTI has a different effect on the rise of CD4 cells compared to a treatment made up of     three NRTIs plus an NNRTI. CD4 cells are cells of the immune system that fight infection.     This study will also try to see if the combination of drugs used in this study is safe to use     in HIV-positive patients.   "
164429|NCT00004856|"     Phase II trial to study the effectiveness of trastuzumab in treating patients who have     previously treated, locally advanced, or metastatic cancer of the urothelium. Monoclonal     antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to     them without harming normal cells.   "
164430|NCT00004857|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer     cells and either kill them or deliver cancer-killing substances to them without harming     normal cells.      PURPOSE: Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in     treating patients who have chronic lymphocytic leukemia.   "
164431|NCT00004858|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have recurrent acute lymphoblastic leukemia or non-Hodgkin's lymphoma.   "
164432|NCT00004859|"     This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and     thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation     therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer.     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping     blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation     therapy is more effective with or without thalidomide.   "
164453|NCT00004881|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have advanced cancer.   "
164435|NCT00004862|"     Phase I trial to study the effectiveness of augmerosen plus fludarabine and cytarabine in     treating patients who have refractory or relapsed acute myeloid leukemia or acute     lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells     from dividing so they stop growing or die. Gene therapy such as augmerosen may make cancer     cells more sensitive to chemotherapy drugs. Combining more than one drug with augmerosen may     kill more cancer cells.   "
164436|NCT00004863|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of paclitaxel and GEM 231 in treating     patients who have recurrent or refractory solid tumors.   "
164437|NCT00004864|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Gene therapy such as GEM 231 may inhibit the growth of cancer cells     and make the tumor more sensitive to chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of combining docetaxel and GEM 231 in     treating patients who have recurrent or refractory solid tumors.   "
164438|NCT00004865|"     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of cetuximab plus cisplatin in treating     patients who have metastatic or recurrent cancer of the head and neck that has not responded     to previous cisplatin-based chemotherapy.   "
164439|NCT00004866|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating women who have     advanced or recurrent cancer of the cervix.   "
164440|NCT00004867|"     RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to     determine the stage of esophageal cancer.      PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 positron emission     tomography determines tumor stage in patients with esophageal cancer.   "
164441|NCT00004868|"     RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the     tumor.      PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have     recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.   "
164442|NCT00004870|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Gene therapy such as oblimersen may make tumor cells more sensitive     to chemotherapy drugs. Combining irinotecan and oblimersen may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining oblimersen and irinotecan     in treating patients who have metastatic or recurrent colorectal cancer.   "
164443|NCT00004871|"     RATIONALE: Azacitidine plus phenylbutyrate may help leukemia cells develop into normal white     blood cells.      PURPOSE: Phase I trial to study the effectiveness of combining azacitidine and phenylbutyrate     in treating patients who have acute myeloid leukemia or myelodysplastic syndrome.   "
164445|NCT00004873|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is most effective in treating advanced     stomach cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of     combination chemotherapy in treating patients who have advanced stomach cancer.   "
164446|NCT00004874|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells.      PURPOSE: Phase III trial to determine the effectiveness of monoclonal antibody therapy in     treating patients who have relapsed or refractory non-Hodgkin's lymphoma.   "
164447|NCT00004875|"     RATIONALE: Heparin or enoxaparin may be effective in preventing the formation of blood clots     in patients with cancer who are undergoing surgery to remove the tumor.      PURPOSE: Randomized clinical trial to compare the effectiveness of heparin with that of     enoxaparin in patients who have cancer.   "
164448|NCT00004876|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Thalidomide may stop the growth of ovarian cancer by stopping blood     flow to the tumor.      PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with     thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial     cancer.   "
164449|NCT00004877|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of BMS-214662 in treating patients who have     advanced solid tumors.   "
164450|NCT00004878|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy used to kill cancer cells. Sometimes the transplanted cells can be     rejected by the body's normal tissues. Donor lymphocytes that have been treated in the     laboratory may prevent this from happening.      PURPOSE: Randomized phase II trial to study the effectiveness of donor lymphocytes to prevent     graft-versus-host disease in patients who are undergoing peripheral stem cell transplantation     for chronic myeloid leukemia.   "
164451|NCT00004879|"     RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them     or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating     patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon,     rectal, esophageal, or gastroesophageal junction cancer.   "
164452|NCT00004880|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have advanced kidney cancer.   "
164454|NCT00004883|"     Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage     IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies     can locate tumor cells and either kill them or deliver tumor-killing substances to them     without harming normal cells   "
164455|NCT00004884|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin     in treating advanced pancreatic cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine     with that of docetaxel and cisplatin in treating patients who have metastatic or locally     advanced pancreatic cancer.   "
164456|NCT00004885|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether fluorouracil and leucovorin plus     irinotecan is more effective than fluorouracil and leucovorin alone for colorectal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and     leucovorin with or without irinotecan in treating patients who have metastatic colorectal     cancer.   "
164457|NCT00004886|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of MS 209 plus docetaxel in treating     patients who have advanced solid tumors.   "
164458|NCT00004887|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether paclitaxel and carboplatin is more     effective than standard chemotherapy for advanced non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and     carboplatin chemotherapy with that of standard chemotherapy in treating patients who have     stage III or stage IV non-small cell lung cancer that cannot be removed during surgery.   "
164459|NCT00004888|"     Phase II trial to study the effectiveness of combination chemotherapy with or without     trastuzumab in treating women who have metastatic breast cancer. Drugs used in chemotherapy     use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal     antibodies such as trastuzumab can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.   "
164460|NCT00004889|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have     Waldenstrom's macroglobulinemia.   "
164461|NCT00004890|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer     cells. Biomed 101 may protect normal cells from the side effects of interleukin-2.      PURPOSE: Phase I trial to study the effectiveness of Biomed 101 in treating patients     receiving interleukin-2 for kidney cancer.   "
164462|NCT00004891|"     RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect     the extent of locally advanced primary rectal cancer and may also help to measure a patient's     response to treatment.      PURPOSE: This clinical trial is studying how well PET and CT scans detect residual or     metastatic disease in patients with locally advanced primary rectal cancer that can be     removed during surgery.   "
165371|NCT00005176|"     To investigate the clinical, genetic and cardiologic aspects of the Long QT Syndrome, a     predominantly hereditary disease with episodic malignant arrhythmias and sudden death, and a     demonstrated gene linkage in a large pedigree.   "
164463|NCT00004892|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving drugs in different ways may     kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of O6-benzylguanine and implanted     carmustine wafers in treating patients who have recurrent malignant glioma.   "
164464|NCT00004893|"     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by     stimulating a person's white blood cells to kill breast cancer cells.      PURPOSE: Randomized phase II trial to study the effectiveness of interleukin-12 in treating     patients who have metastatic or recurrent breast cancer.   "
164465|NCT00004895|"     RATIONALE: Palliative therapy with octreotide may help patients who have bowel obstruction     that cannot be removed by surgery to live longer and more comfortably.      PURPOSE: Phase II trial to study the effectiveness of octreotide as palliative therapy in     treating patients who have cancer-related bowel obstruction that cannot be removed by     surgery.   "
164466|NCT00004896|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with donor bone marrow transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of busulfan and cyclophosphamide followed     by bone marrow transplantation in treating patients who have acute myelogenous leukemia or     myelodysplastic syndrome.   "
164467|NCT00004897|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.     Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug     and combining chemotherapy with interferon alfa, surgery, and/or radiation therapy may kill     more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and interferon     alfa followed by surgery and/or radiation therapy in treating patients who have stage I,     stage II, or stage III esophageal cancer.   "
164468|NCT00004898|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Peripheral stem cell transplantation may allow doctors to give higher doses of     chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy and chemotherapy     plus peripheral stem cell transplantation in treating patients who have high-grade lymphoma     or acute lymphoblastic leukemia.   "
164484|NCT00004914|"     RATIONALE: Exercise may decrease anemia-related fatigue, improve strength, and build up lost     muscle tissue. Epoetin alfa may help improve cancer-related anemia, energy levels, and     quality of life. Exercise plus epoetin alfa may be effective treatment for anemia-related     fatigue.      PURPOSE: Phase II trial to study the effectiveness of exercise plus epoetin alfa in treating     cancer patients who have anemia-related fatigue.   "
164469|NCT00004899|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing and die. Bone marrow transplantation may be able to replace cells that     were destroyed by chemotherapy. Colony-stimulating factors such as filgrastim may increase     the number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus bone marrow     transplantation and filgrastim in treating patients who have acute myelogenous leukemia or     myelodysplastic syndrome.   "
164470|NCT00004900|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell     transplantation in treating women who have metastatic breast cancer.   "
164471|NCT00004901|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus     radiation therapy in treating patients who have advanced mouth cancer.   "
164472|NCT00004902|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of tocladesine in treating patients who     have recurrent or refractory multiple myeloma.   "
164473|NCT00004903|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral     stem cell transplantation in treating patients who have multiple myeloma.   "
164474|NCT00004904|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy and radiation therapy used to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of treated donor stem cell transplantation     in treating patients who have hematologic cancer.   "
164475|NCT00004905|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to     give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Clinical trial to study the effectiveness of combination chemotherapy plus     peripheral stem cell transplantation in treating patients who have chronic myelogenous     leukemia or acute leukemia.   "
164476|NCT00004906|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     peripheral stem cell transplantation in treating women who have metastatic breast cancer.   "
165372|NCT00005177|"     To study weight maintenance behaviors, weight trends, and behavioral differences between     healthy, normal weight and mildly obese adults.   "
164477|NCT00004907|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Bone marrow or peripheral stem cell transplantation may allow the doctor to give     higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and radiation therapy     plus bone marrow or peripheral stem cell transplantation in treating patients who have     refractory or relapsed T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma.   "
164478|NCT00004908|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Peripheral stem cell transplantation may allow doctors to give higher doses of     chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cyclophosphamide     plus peripheral stem cell transplantation in treating patients who have recurrent or     refractory Hodgkin's disease or non-Hodgkin's lymphoma.   "
164479|NCT00004909|"     RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help     determine the intermediate- and long-term effects of the treatment on these patients.      PURPOSE: This clinical trial studies the effects of chemotherapy given by mouth versus     chemotherapy given by infusion on quality of life in patients with recurrent ovarian     epithelial cancer.   "
164480|NCT00004910|"     RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than     surgery for treating cancer-related duodenal obstruction and may have fewer side effects and     improve recovery.      PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents     in treating patients who have cancer-related obstruction of the duodenum.   "
164481|NCT00004911|"     RATIONALE: The use of endoscopy to place a metal stent in the large intestine is less     invasive than surgery for treating cancer-related bowel obstruction and may have fewer side     effects and improve recovery.      PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of a metal stent     in treating patients who have cancer-related bowel obstruction.   "
164482|NCT00004912|"     RATIONALE: Megestrol helps improve appetite. Exercise may decrease cancer-related fatigue,     improve strength, and build up lost muscle tissue. Exercise plus megestrol may be effective     treatment for cancer-related weight loss.      PURPOSE: Phase II trial to study the effectiveness of megestrol plus exercise to improve     appetite, increase strength, gain lean body tissue, and decrease fatigue in patients who have     cancer-related weight loss.   "
164483|NCT00004913|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating     patients who have advanced solid tumors.   "
164569|NCT00003981|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of E7070 in treating patients who have     solid tumors.   "
164485|NCT00004915|"     RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy     using raloxifene may fight endometrial cancer by reducing the production of estrogen.      PURPOSE: Phase II trial to study the effectiveness of raloxifene in treating patients who     have persistent or recurrent endometrial cancer.   "
164486|NCT00004916|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of ifosfamide, teniposide, and     paclitaxel in treating patients who have relapsed non-Hodgkin's lymphoma.   "
164487|NCT00004917|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may     stimulate red blood cell production and treat anemia in patients with head and neck cancer.     It is not yet known whether receiving radiation therapy with epoetin alfa is more effective     than radiation therapy alone in treating anemic patients with head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without epoetin alfa in treating anemic patients who have head and neck cancer.   "
164488|NCT00004918|"     Vaccines made from peptides that are found on leukemia cells may make the body build an     immune response and kill cancer cells. Combining vaccine therapy with the immune adjuvant     Montanide ISA-51 may be a more effective treatment for chronic myeloid leukemia, acute     myeloid leukemia, or myelodysplastic syndrome. This phase I/II trial is studying the side     effects and best dose of vaccine therapy when given with Montanide ISA-51 and to see how well     they work in treating patients with chronic myeloid leukemia, acute myeloid leukemia, or     myelodysplastic syndrome   "
164489|NCT00004919|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the     side effects of chemotherapy. Phase I trial to study the effectiveness of irinotecan and     cisplatin with or without amifostine in treating children who have solid tumors that have not     responded to previous therapy.   "
164490|NCT00004920|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether receiving cisplatin with raltitrexed is     more effective than cisplatin alone for malignant mesothelioma.      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without     raltitrexed in treating patients who have malignant mesothelioma of the pleura.   "
164491|NCT00004921|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which chemotherapy regimen is most effective for ovarian epithelial cancer.      PURPOSE: This randomized phase III trial is studying high-dose chemotherapy to see how well     it works compared to standard chemotherapy in treating patients with stage III or stage IV     ovarian epithelial cancer that has been removed during surgery.   "
164492|NCT00004922|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who     have advanced neuroendocrine tumors.   "
164493|NCT00004923|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and irinotecan in treating     patients who have advanced solid tumors.   "
164494|NCT00004924|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel together with irinotecan     works in treating patients with advanced non-small cell lung cancer.   "
164495|NCT00004925|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells.      PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab     in treating women who have locally advanced, inflammatory, or metastatic breast cancer.   "
164496|NCT00004926|"     RATIONALE: ILX23-7553 may help solid tumor cells develop into normal cells.      PURPOSE: Phase I trial to study the effectiveness of ILX23-7553 in treating patients who have     solid tumors that have not responded to previous therapy.   "
164497|NCT00004927|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have     advanced solid tumors that have not responded to previous therapy.   "
164498|NCT00004928|"     RATIONALE: Calcitriol may help prostate cancer cells develop into normal cells. Zoledronate     may delay or prevent the formation of bone metastases. Combining calcitriol and zoledronate     may be an effective treatment for progressive prostate cancer.      PURPOSE: Phase I trial to study the effectiveness of combining calcitriol with zoledronate in     treating patients who have progressive prostate cancer.   "
164499|NCT00004929|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy given with QS21 in     treating patients who have progressive prostate cancer.   "
164500|NCT00004930|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients     who have primary lung cancer or lung metastases.   "
164501|NCT00004931|"     Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with     or without oxaliplatin in treating patients who have stage II or stage III colon cancer.     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining more than one drug may kill more tumor cells. It is not yet known     which combination chemotherapy regimen is more effective for colon cancer   "
164502|NCT00004932|"     RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an     effective treatment for leukemia.      PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients     who have recurrent leukemia.   "
164503|NCT00004933|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. It is not yet known if homoharringtonine is more effective than     hydroxyurea for chronic myelogenous leukemia that has not responded to interferon alfa.      PURPOSE: Randomized phase III trial to compare the effectiveness of homoharringtonine with     that of hydroxyurea in treating patients who have chronic myelogenous leukemia that has not     responded to interferon alfa.   "
164504|NCT00004934|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether receiving paclitaxel and carboplatin     with epirubicin is more effective than paclitaxel and carboplatin alone for ovarian     epithelial, fallopian tube, or peritoneal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and     carboplatin with or without epirubicin in treating patients who have stage IIB, stage III, or     stage IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer.   "
164505|NCT00004935|"     RATIONALE: To compare efficacy, toxicity and quality of life of the sequential administration     of Her alone followed, at PD, by the combination with Chemotherapy (Arm A) vs. the upfront     combination of Her and Chemotherapy (Arm B) in patients with advanced/metastatic breast     cancer.      PURPOSE: Trial SAKK 22/99 addresses clinically relevant and currently unresolved questions     regarding the optimal use of Herceptin in the treatment of patients with advanced/metastatic     breast cancer.   "
164506|NCT00004936|"     RATIONALE: Imaging procedures such as MRI or CT scans may improve the ability to detect     cervical cancer and determine the extent of disease.      PURPOSE: Diagnostic trial to determine the effectiveness of MRI and CT scans in evaluating     invasive cervical cancer before treatment of patients.   "
164507|NCT00004937|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of acridine carboxamide in treating     patients who have recurrent glioblastoma multiforme.   "
164508|NCT00004938|"     OBJECTIVE:      I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral     sporotrichosis.   "
164509|NCT00004939|"     OBJECTIVES:      I. Assess the efficacy of 3,4-diaminopyridine in patients with stable chronic demyelinating     polyneuropathy.   "
164510|NCT00004940|"     OBJECTIVES:      I. Determine the long-term efficacy and safety of L-cysteine in the prevention     photosensitivity in patients with erythropoietic protoporphyria.   "
164511|NCT00004941|"     OBJECTIVES:      I. Evaluate the efficacy of chimeric monoclonal antibody (cA2) compared with placebo in     closure of enterocutaneous fistulae in patients with Crohn's disease.   "
164526|NCT00003926|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.     Chemoprotective drugs such as amifostine may protect normal cells from the side effects of     high-dose chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side     effects of peripheral stem cell transplantation in treating patients who have high-risk or     relapsed solid tumors.   "
164512|NCT00004978|"     The purpose of this study is to see if it is effective to give HIV positive patients     recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed     over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease     progression.      Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping     viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the     body of the virus, and the immune system is never completely restored in HIV positive     patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to     their anti-HIV therapy will help improve their immune systems and keep them healthier over a     longer period of time. rIL-2 is a hormone naturally produced by the body during an immune     response to a microbial infection.   "
164513|NCT00004979|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining topotecan and paclitaxel in     treating patients who have advanced non-small cell lung cancer or other advanced solid     tumors.   "
164514|NCT00004980|"     OBJECTIVES:      I. Determine the effect of repetitive transcranial magnetic stimulation on treatment     refractory auditory hallucinations of patients with schizophrenia.   "
164515|NCT00004981|"     The purpose of this study is to look at the safety and effectiveness of a pill called     Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and     abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this     study, Trizivir will be compared to Combivir plus abacavir.   "
164516|NCT00004982|"     Patients with beta-thalassemia (Cooley's Anemia) continue to suffer from the     transfusion-induced iron overload due to the inadequacies of current iron-chelation therapy.     Compliance with the use of the only FDA-approved drug for removing excess iron from patients     (Desferal) continues to be a major problem despite convincing evidence that it markedly     reduces morbidity and prolongs life. The full potential of iron-chelation therapy will not be     realized until an orally-effective drug is available. This small trial is testing the premise     that a combination of drugs as a new approach to iron chelation therapy may reduce side     effects and increase efficacy. If both drugs can be given orally, there may be a better     chance of finding a suitable alternative to Desferal. Several combinations of experimental     iron chelating drugs are being used in this trial.   "
164517|NCT00004983|"     The purpose of this ongoing work in Starr County, located on the Texas-Mexico border, is to     conduct clinical studies to determine the effectiveness of diabetes self-management programs     designed specifically for Mexican Americans. The programs meet national standards for     diabetes self-management education. They are provided in community settings with the primary     purpose of improving the health of Mexican Americans with diabetes and their family members,     who either have diabetes or are at risk for developing diabetes.      The diabetes self-management programs are provided in Spanish and are directed by bilingual     Hispanic clinical nurse specialists, dietitians, and community health workers. Key elements     of the programs include instruction on nutrition, self-monitoring of blood glucose, exercise,     and other diabetes self-management topics, as well as group support to promote behavioral     changes.      In the original study (1994-1998), 256 Mexican American adults diagnosed with type 2 diabetes     and 256 family members or other support persons were enrolled. For one year, the people with     diabetes, along with their family members, attended small group sessions held in churches,     community health clinics, adult day care centers, and schools. Information on the     effectiveness of the program was collected at 3, 6, and 12 months; and annually thereafter.      Findings of the original study suggested that the program had a positive impact on diabetes     metabolic control. Levels of diabetes knowledge and rates of glucose self-monitoring and     attendance suggested that a shorter program - one that incorporated critical elements of the     previous successful strategy - might result in similar improvements. Thus, the goal of the     new study, funded in June 1999, was to shorten the original program and to compare it to the     previous successful program in terms of short- and long-term health outcomes.      To identify key components of the previous program, we are exploring differences between     subjects who successfully integrated self-care components of the program and who experienced     significant improvements in metabolic control and those who were not as successful. The     program is being revised and shortened, based on this information. Beginning in April 2000,     we will start recruiting participants for the clinical trial of the revised program.   "
164518|NCT00004984|"     The Diabetes Prevention Trial of Type 1 (DPT-1) is a multicenter randomized, controlled     clinical trial designed to determine whether it is possible to delay or prevent the clinical     onset of type 1 diabetes through daily doses of insulin in individuals determined to be at     risk for the disease. The parenteral insulin trial in DPT-1 has been completed, however, the     oral insulin trial is still recruiting. Over 350 sites in the United States, Canada, and     Puerto Rico are taking part in the study. Screening of patients is ongoing; approximately     100,000 nondiabetic relatives of persons with type 1 diabetes have been screened to detect     the presence of islet cell antibodies. Those individuals found to have islet cell antibodies     are being staged to determine their risk of diabetes based on genetic, immunologic, and     metabolic characteristics. Those individuals found to be at intermediate risk of diabetes are     randomized to receive insulin orally or to receive placebo. Patients are being followed for     up to six years.   "
164519|NCT00004985|"     The purpose of this study is to look at the effectiveness of an anti-HIV drug combination     that adds capravirine in patients who have failed their first drug combination treatment.   "
164520|NCT00004986|"     The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in     AIDS patients with nitazoxanide.   "
164521|NCT00004987|"     The purpose of this study is to look at the safety and effectiveness of dextrin sulfate in     AIDS patients who have failed conventional anti-HIV treatment.   "
164522|NCT00004988|"     This study will examine the safety and toxicities of intravenously administering a     genetically modified type of Salmonella bacteria (VNP20009) and its impact on tumor growth in     advanced or metastatic cancer (cancer that has spread from the primary site). The first     patients in the study will be given the smallest dose of VNP20009, and those who enter later     will receive increasingly larger doses. This will be done to determine the maximum dose that     can be given without serious side effects.      Normally, Salmonella bacteria ingested in food or water can cause diarrhea or more severe     illness. The bacteria in this study are altered genetically so they can be injected through a     vein and circulate in the blood with less likelihood of causing side effects. It is believed     that the bacteria will travel in the blood to the tumor and infect it. In studies of mice,     tumor growth slowed in animals whose tumors were infected with VNP0009.      Patients with advanced or metastatic cancer 18 years of age or older whose disease is not     responding to standard treatment, or for which there is no treatment, may be eligible for     this study. Candidates will undergo a medical history and physical examination, including     blood tests, scans, X-rays, electrocardiogram, and urine, stool and blood cultures.      Study participants will be admitted to the hospital for 2 to 4 days. On day 1, they will     receive the first dose of VNP0009, infused over a 30-minute period through an intravenous     catheter (a small plastic tube inserted into a vein). Blood will be drawn every day to     determine if the bacteria are still in the body. After discharge, patients will return to the     hospital on days after approximately 1-2 weeks and again after 4-5 weeks for additional blood     tests to measure levels of the bacteria and for collection of blood, urine and stool samples.     Patients whose tumors are on or just beneath the skin may be asked to have one or two tumors     removed surgically.      Patients will have tests after approximately 4-5 weeks, including CTs and X-rays, to     determine the size and extent of the tumor. Patients whose tumor remained the same size or     smaller than before starting treatment, and whose side effects were acceptable will be     offered a second treatment cycle. Those whose tumor grew during treatment will be taken off     the study. Patients remaining in the study will begin the second cycle on approximately day     36. Tumor growth will be evaluated again between days 64 and 70, and a third cycle will be     offered to patients whose tumors have remained stable or have shrunk. Patients may have up to     12 treatment cycles as long as evaluations continue to show the tumor is stable or shrinking.     Completing all 12 cycles takes about 13 months. Patients will continue to be evaluated after     treatment ends, if they agree to continued follow-up.      Patients must follow health precautions to prevent infecting others with Salmonella bacteria     as long as they, themselves, remain infected. These include, for example, stringent hand     washing practices and avoiding contact with people with weakened immune systems. All the     precautions will be explained to the study participants.      Patients who leave the study must take antibiotic therapy to rid the body of any remaining     bacteria. They will return for urine, stool and blood cultures 30 days after the start of     antibiotics, and may undergo three types of scans to look for sites of infection. Treatment     will be given as needed.   "
164523|NCT00003923|"     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to     light to kill tumor cells. This may be effective treatment for cancer of the bile duct,     gallbladder, or pancreas.      PURPOSE: Phase II trial to determine the effectiveness of photodynamic therapy in treating     patients who have cancer of the bile duct, gallbladder, or pancreas.   "
164524|NCT00003924|"     RATIONALE: Interferon-alfa may interfere with the growth of cancer cells. Giving     interferon-alfa following chemotherapy and peripheral stem cell transplantation may be an     effective treatment for Hodgkin's disease or non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa-2b     following chemotherapy and stem cell transplantation in treating patients who have recurrent     or refractory Hodgkin's disease or non-Hodgkin's lymphoma.   "
164525|NCT00003925|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine,     fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not     responded to previous therapy.   "
164527|NCT00003927|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.     Amifostine may protect normal cells from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, amifostine,     and peripheral stem cell transplantation in treating patients who have stage II, stage III,     or stage IV breast cancer.   "
164528|NCT00003928|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: This phase II trial is studying how well gemcitabine and cisplatin work in treating     patients with metastatic kidney cancer.   "
164529|NCT00003929|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Combining chemotherapy with radiation therapy may kill more cancer cells.     Colony-stimulating factors such as filgrastim allow doctors to give higher doses of     chemotherapy drugs to kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of lomustine, procarbazine, filgrastim,     and radiation therapy in treating patients who have primary central nervous system lymphoma.   "
164530|NCT00003930|"     RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy     use different ways to stop tumor cells from dividing so they stop growing or die. Combining     radiation therapy with chemotherapy and surgery may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination     chemotherapy in treating patients who have stage II or stage III bladder cancer that can be     removed by surgery.   "
164531|NCT00003931|"     RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect     acute myeloid leukemia and determine the extent of disease.      PURPOSE: Diagnostic study to try to detect changes in the genes of patients who have acute     myeloid leukemia.   "
164532|NCT00003933|"     RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect     acute lymphocytic leukemia and determine the extent of disease.      PURPOSE: Diagnostic study to try to detect changes in the genes of children who have been     treated for relapsed acute lymphocytic leukemia.   "
164533|NCT00003934|"     This randomized phase III trial is studying tretinoin and combination chemotherapy to see how     well they work compared to tretinoin, combination chemotherapy, and arsenic trioxide in     treating patients with acute promyelocytic leukemia that has not been treated previously.     Drugs used in chemotherapy, such as daunorubicin, cytarabine, mercaptopurine, methotrexate,     and arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop     growing or die. Tretinoin may help leukemia cells develop into normal white blood cells. It     is not yet known which regimen is more effective for acute promyelocytic leukemia.   "
164570|NCT00003982|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating patients who have     solid tumors.   "
164534|NCT00003935|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vincristine plus etoposide and radiation     therapy in treating children who have newly diagnosed brain stem glioma.   "
164535|NCT00003936|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who     have recurrent or refractory Hodgkin's disease.   "
164536|NCT00003937|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.     Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of     chemotherapy.      PURPOSE: Phase III trial to study the effectiveness of three combination chemotherapy     regimens plus dexrazoxane in treating patients who have newly diagnosed nonmetastatic     osteosarcoma.   "
164537|NCT00003938|"     RATIONALE: Liposomal amphotericin B may be effective in controlling fever and     granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more     effective in treating cancer patients who have these conditions.      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal     amphotericin B in treating granulocytopenia and fever in cancer patients.   "
164538|NCT00003939|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients     who have advanced soft tissue sarcoma.   "
164539|NCT00003941|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.     Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy and     kill more cancer cells. It is not yet known whether chemotherapy and peripheral stem cell     transplant is more effective than chemotherapy alone.      PURPOSE: This randomized phase III trial is studying how well combination chemotherapy works     when given with peripheral stem cell transplant and how it compares with combination     chemotherapy alone in treating men with previously untreated germ cell cancer.   "
164540|NCT00003942|"     RATIONALE: Inserting the gene for RevM10 into a person's peripheral stem cells may improve     the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.      PURPOSE: Phase I/II trial to study the effectiveness of RevM10-treated stem cells plus     chemotherapy and peripheral stem cell transplantation in treating patients who have     HIV-related non-Hodgkin's lymphoma.   "
164541|NCT00003943|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     peripheral stem cell transplantation in treating patients who have metastatic cancer.   "
164542|NCT00003944|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     peripheral stem cell transplantation in treating patients who have stage III or stage IV     ovarian, fallopian tube, or primary peritoneal cancer.   "
164543|NCT00003945|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which chemotherapy regimen is more effective for cervical cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of three different     chemotherapy regimens in treating patients with stage IVB, recurrent, or persistent cervical     cancer.   "
164544|NCT00003946|"     RATIONALE: Hormone therapy may be an effective treatment for endometrial cancer.      PURPOSE: Phase II trial to study the effectiveness of danazol in treating patients with     advanced or recurrent endometrial cancer.   "
164545|NCT00003950|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Cyclosporine may relieve the diarrhea caused by irinotecan.      PURPOSE: Phase II trial to study the effectiveness of irinotecan and cyclosporine in treating     patients who have metastatic, advanced, or locally recurrent colorectal cancer that has not     responded to fluorouracil.   "
164546|NCT00003951|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have     metastatic cancer of the pancreas that has not been previously treated or that has not     responded to previous chemotherapy.   "
164547|NCT00003953|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel followed by     surgery in treating women who have stage II or stage III breast cancer.   "
164548|NCT00003954|"     In this study donor bone marrow transplantation is divided into a two step process to try to     significantly reduce the side effects of the procedure yet still provide patients with     multiple myeloma the benefits of this procedure   "
164549|NCT00003955|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with     radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.   "
164550|NCT00003956|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of SCH 66336, fluorouracil, and leucovorin     in treating patients who have advanced cancer.   "
164551|NCT00003957|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with autologous peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's     lymphoma.   "
164552|NCT00003958|"     This randomized phase III trial is comparing two different combination chemotherapy regimens     to see how well each works in treating patients with previously untreated rhabdomyosarcoma or     sarcoma. Drugs used in chemotherapy, such as dactinomycin, cyclophosphamide, vincristine, and     topotecan, use different ways to stop tumor cells from dividing so they stop growing or die.     It is not yet known which combination chemotherapy regimen is more effective in treating     rhabdomyosarcoma.   "
164553|NCT00003959|"     RATIONALE: A vaccine made from a person's myelodysplasia cells may make the body build an     immune response to kill cancer cells. Combining vaccine therapy with sargramostim may kill     more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in     treating patients who have myelodysplastic syndrome.   "
164554|NCT00003960|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Bone marrow transplantation may allow the doctor to give higher     doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor     bone marrow transplantation in treating patients who have hematologic cancer.   "
164555|NCT00003961|"     RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of     immune cells found in bone marrow or peripheral blood.      PURPOSE: Phase II trial to study the effectiveness of sargramostim after bone marrow     transplantation in treating patients who have myelodysplastic syndrome.   "
164556|NCT00003962|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 following bone marrow     transplantation in treating patients who have hematologic cancer at risk of relapse.   "
164557|NCT00003963|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy     use different ways to stop cancer cells from dividing so they stop growing or die. Combining     monoclonal antibody therapy with chemotherapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab plus     chemotherapy with vinorelbine in treating patients with B-cell non-Hodgkin's lymphoma that     has relapsed following autologous peripheral stem cell transplantation.   "
164558|NCT00003966|"     RATIONALE: Giving defibrotide may be an effective treatment for liver damage that may result     following peripheral stem cell transplantation.      PURPOSE: This randomized phase II trial is studying defibrotide to see how well it works in     treating patients with severe liver disease after undergoing peripheral stem cell     transplantation.   "
165471|NCT00005982|"     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who     have recurrent or refractory cutaneous T-cell lymphoma   "
164559|NCT00003967|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of topotecan plus etoposide in treating     patients who have recurrent ovarian cancer, peritoneal cancer, or fallopian tube cancer.   "
164560|NCT00003968|"     Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have     metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die.   "
164561|NCT00003969|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of a geldanamycin     analogue in treating patients with advanced cancer.   "
164562|NCT00003970|"     Phase I trial to study genetic testing and the effectiveness of irinotecan in treating     patients who have solid tumors and lymphoma. Drugs used in chemotherapy use different ways to     stop cancer cells from dividing so they stop growing or die. Genetic testing for a specific     enzyme may help doctors determine whether side effects from or response to chemotherapy are     related to a person's genetic makeup   "
164563|NCT00003972|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It     is not yet known which regimen of combination chemotherapy is more effective for breast     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of     combination chemotherapy followed by peripheral stem cell transplantation in treating     patients who have stage II or stage IIIA breast cancer.   "
164564|NCT00003974|"     RATIONALE: Vaccines made from a person's tumor may help the body build an immune response to     kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have undergone surgery to remove stage I, stage II, or stage IIIA non-small cell lung cancer     or stage I or stage II mesothelioma.   "
164565|NCT00003976|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of E7070 in treating patients who have     solid tumors.   "
164566|NCT00003977|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients     with recurrent or persistent cervical cancer that cannot be treated with surgery or radiation     therapy.   "
164567|NCT00003979|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have     solid tumors.   "
164568|NCT00003980|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of BIBX 1382 in treating patients who have     solid tumors.   "
164761|NCT00005337|"     To determine whether deficient vagal antagonism of sympathetic nervous system (SNS) actions     on the heart contributed to increased coronary heart disease risk in hostile persons.   "
164571|NCT00003984|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have primary myelodysplastic syndrome.   "
164572|NCT00003985|"     RATIONALE: Biological therapies such as KRN7000 use different ways to stimulate the immune     system and stop cancer cells from growing.      PURPOSE: Phase I trial to study the effectiveness of KRN7000 in treating patients who have     solid tumors that have not responded to previous treatment.   "
164573|NCT00003989|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ISIS 3521 in treating patients who have     advanced, unresectable, or metastatic non-small cell lung cancer or unresectable or     metastatic melanoma.   "
164574|NCT00003991|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myeloid     leukemia cells. Histamine dihydrochloride may prolong remission and reduce the risk of     relapse in patients with acute myeloid leukemia in remission.      PURPOSE: Randomized phase III trial to determine the effectiveness of interleukin-2 plus     histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in     remission following previous therapy.   "
164575|NCT00003992|"     Randomized phase II trial to study the effectiveness of chemotherapy with paclitaxel and the     monoclonal antibody trastuzumab followed by chemotherapy in treating women who have stage II     or stage IIIA breast cancer that overexpresses HER2. Drugs used in chemotherapy use different     ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can     locate tumor cells and deliver tumor-killing substances to them without harming normal cells.     Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.   "
164576|NCT00003993|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill     cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-2 when     given together with bryostatin 1 in treating patients with refractory solid tumors or     lymphoma.   "
164577|NCT00003994|"     Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they     stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective     drugs such as amifostine may protect normal cells from the side effects of chemotherapy. It     is not yet known which chemotherapy regimen is most effective for children and young adults     with liver cancer. This randomized phase III trial is studying giving combination     chemotherapy together with amifostine to see how well it works compared to combination     chemotherapy alone in treating patients with liver cancer.   "
164861|NCT00005437|"     To conduct a longitudinal study investigating the physical activity patterns, the     psychosocial predictors of physical activity, and the effects of physical activity changes on     blood pressure and body fatness in a cohort of African-American girls, ages 11-17.   "
164578|NCT00003995|"     Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab and     chemotherapy with irinotecan in treating patients who have stage IV colorectal cancer that     overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.   "
164579|NCT00003996|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation     therapy in treating patients who have newly diagnosed glioblastoma multiforme.   "
164580|NCT00003997|"     Phase I trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating patients     who have refractory myelodysplastic syndrome, acute myeloid leukemia, acute lymphocytic     leukemia, or blastic phase chronic myelogenous leukemia. Drugs used in chemotherapy use     different ways to stop cancer cells from dividing so they stop growing or die.   "
164581|NCT00003998|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known which combination chemotherapy regimen is more effective for treating ovarian     epithelial cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus     paclitaxel with that of carboplatin plus docetaxel in treating patients who have ovarian     epithelial cancer.   "
164582|NCT00004001|"     RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop tumor     cells from dividing so they stop growing or die. Combining more than one drug and giving     drugs in different ways may kill more tumor cells. It is not yet known whether estramustine     plus docetaxel is more effective than mitoxantrone plus prednisone for prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of estramustine plus     docetaxel with that of mitoxantrone plus prednisone in treating patients who have stage IV     prostate cancer that has not responded to hormone therapy.   "
164583|NCT00004002|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have     advanced solid tumors or lymphoma that have not responded to previous treatment.   "
164584|NCT00004003|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     adult patients who have stage III or stage IV pancreatic cancer that cannot be removed by     surgery.   "
164585|NCT00004004|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of procarbazine in treating patients who     have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme     following treatment with radiation therapy.   "
164602|NCT00004028|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of carmustine in treating patients who are     undergoing surgery for recurrent malignant glioma.   "
164586|NCT00004005|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work     in different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy     drug with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with radiation therapy works in treating patients with stage III or stage IV colorectal     carcinoma (cancer), other refractory carcinoma (cancer), or metastatic adenocarcinoma     (cancer) of unknown primary origin.   "
164587|NCT00004006|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs     and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation     therapy followed by bone marrow transplantation in treating patients who have retinoblastoma.   "
164588|NCT00004008|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who     have ovarian epithelial cancer that has not responded to previous chemotherapy.   "
164589|NCT00004009|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have     refractory or recurrent acute leukemia or chronic myelogenous leukemia.   "
164590|NCT00004010|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.     Radiation therapy uses high-energy x-rays to damage cancer cells. Giving radiation therapy     after chemotherapy may be an effective treatment for Hodgkin's disease.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation     therapy in treating children who have previously untreated stage II, stage III, or stage IV     Hodgkin's disease.   "
164591|NCT00004011|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known if surgery plus combination chemotherapy is more effective than surgery alone for     non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without     combination chemotherapy in treating patients who have non-small cell lung cancer.   "
164592|NCT00004012|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who     have recurrent ovarian, fallopian tube, or primary peritoneal cancer.   "
164593|NCT00004013|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. Paclitaxel may stop the growth of breast cancer by stopping blood flow to the tumor.      PURPOSE: Phase II trial to compare the effectiveness of paclitaxel with or without     trastuzumab following peripheral stem cell transplantation in treating patients who have     refractory stage IV breast cancer.   "
164594|NCT00004014|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating     patients with prostate cancer that has not responded to hormone therapy.   "
164595|NCT00004015|"     RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming     normal tissue.      PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron     capture therapy following surgery in treating patients with glioblastoma multiforme removed     during surgery.   "
164596|NCT00004016|"     RATIONALE: Interferon gamma may interfere with the growth of cancer cells and may be an     effective treatment for melanoma and solid tumors.      PURPOSE: Phase I trial to study the effectiveness of interferon gamma in treating patients     with recurrent or metastatic melanoma or other solid tumors.   "
164597|NCT00004017|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver     tumor-killing substances to them without harming normal cells. This may be an effective     treatment for some types of brain tumors.      PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in     treating patients who have glioblastoma multiforme or anaplastic astrocytoma.   "
164598|NCT00004022|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Combining different types of biological therapies may kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery in     treating patients who have stage III or stage IV melanoma.   "
164599|NCT00004024|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Combining different types of biological therapies may kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery     and radiation therapy in treating patients who have primary or recurrent astrocytoma or     oligodendroglioma.   "
164600|NCT00004025|"     RATIONALE: Vaccines made from a person's white blood cells combined with melanoma antigens     may make the body build an immune response to tumor cells. Interleukin-2 may stimulate a     person's white blood cells to kill melanoma cells. Combining vaccine therapy with     interleukin-2 may be an effective treatment for stage III or stage IV melanoma.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without     interleukin-2 in treating patients who have stage III or stage IV melanoma that cannot be     surgically removed.   "
164601|NCT00004026|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. CT-2584 may stop the growth of prostate cancer by stopping blood     flow to the tumor.      PURPOSE: Randomized phase II trial to study the effectiveness of CT-2584 in treating patients     who have metastatic prostate cancer that has not responded to previous therapy.   "
164788|NCT00005364|"     To determine the genetic epidemiology of coronary heart disease (CHD) risk factors in Blacks.   "
164605|NCT00004031|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of     chemotherapy and radiation and kill more cancer cells. It is not yet known whether     chemoradiotherapy plus peripheral stem cell transplantation is more effective than     combination chemotherapy alone in treating non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying chemoradiotherapy and peripheral stem     cell transplantation to see how well they work compared to combination chemotherapy in     treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.   "
164606|NCT00004032|"     Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in     patients with refractory epithelial ovarian cancer. Vaccines made from a person's cancer     cells may make the body build an immune response to and kill their tumor cells. Combining     vaccine therapy with interferon gamma may be a more effective treatment for epithelial     ovarian cancer   "
164607|NCT00004033|"     RATIONALE: Patient abstract not available      PURPOSE: Patient abstract not available   "
164608|NCT00004036|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumors from dividing so they     stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from     the side effects of chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of amifostine plus combination chemotherapy     in treating patients with advanced cancer.   "
164609|NCT00004037|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with     recurrent or refractory ovarian or primary peritoneal cancer.   "
164610|NCT00004038|"     Phase I trial to study the effectiveness of gene therapy plus chemotherapy in treating     patients who have breast cancer. Inserting the p53 gene into a person's cancer cells may     improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.     Combining chemotherapy with gene therapy may kill more tumor cells.   "
164611|NCT00004039|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining interferon alfa or the monoclonal antibody rituximab     with chemotherapy may kill more cancer cells.      PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy plus     interferon alfa or rituximab in treating patients who have high risk stage III or stage IV     lymphoma.   "
164630|NCT00004060|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have     recurrent, metastatic, or unresectable ovarian, fallopian tube, or peritoneal cancer.   "
164612|NCT00004040|"     RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Biological     therapies such as interferon alfa-2b use different ways to stimulate the immune system and     stop cancer cells from growing.      PURPOSE: Phase II trial to study the effectiveness of rituximab or interferon alfa-2b in     treating patients who have chronic lymphocytic leukemia or multiple myeloma in remission.   "
164613|NCT00004041|"     RATIONALE: Inserting the gene for adenovirus p53 into a person's tumor may improve the body's     ability to fight cancer.      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who     have recurrent malignant gliomas.   "
164614|NCT00004042|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody F19 in treating     patients who have advanced or metastatic cancer.   "
164615|NCT00004043|"     RATIONALE: Calcitriol, a form of vitamin D, may be able to prevent or slow the growth of     prostate cancer cells.      PURPOSE: Phase II trial to study the effectiveness of calcitriol in treating patients who     have a rising PSA level following previous treatment for prostate cancer.   "
164616|NCT00004045|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have     metastatic prostate cancer that has not responded to hormone therapy.   "
164617|NCT00004046|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating women who have     metastatic breast cancer that has not responded to previous therapy.   "
164618|NCT00004047|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of DX-8951f in treating patients who have     hematologic cancer.   "
164619|NCT00004048|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver     tumor-killing substances to them without harming normal cells. Chemotherapy uses different     ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell     transplantation may be able to replace immune cells that were destroyed by radioimmunotherapy     or chemotherapy used to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of radioimmunotherapy with or without     doxorubicin plus peripheral stem cell transplantation in treating patients who have thyroid     cancer.   "
164620|NCT00004049|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of SR-45023A in treating patients who have     locally advanced or metastatic solid tumors that have not responded to previous treatment.   "
164621|NCT00004050|"     RATIONALE: Inserting the gene for interleukin-2 into a person's cancer cells may improve the     body's ability to fight cancer. Using Leuvectin to deliver this gene may be an effective     treatment for prostate cancer.      PURPOSE: Phase II trial to study the effectiveness of Leuvectin followed by surgery in     treating patients who have stage II or stage III prostate cancer.   "
164622|NCT00004051|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating patients who have     advanced solid tumors.   "
164623|NCT00004052|"     RATIONALE: Vaccines may make the body build an immune response to kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients     who have chronic myelogenous leukemia.   "
164624|NCT00004054|"     RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy     may fight prostate cancer by reducing the production of androgens. Radiation therapy uses     high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die. It is not yet known whether     hormone therapy plus radiation therapy is more effective with or without combination     chemotherapy for prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus     radiation therapy with or without combination chemotherapy in treating patients who have     prostate cancer.   "
164625|NCT00004055|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of topotecan, paclitaxel, and filgrastim     in treating patients who have previously untreated extensive-stage small cell lung cancer.   "
164626|NCT00004056|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give     higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by     melphalan and peripheral stem cell transplantation in treating children who have newly     diagnosed acute myeloid leukemia that has not been treated previously.   "
164627|NCT00004057|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel and L-778,123 in     treating patients who have recurrent or refractory solid tumors or lymphomas.   "
164628|NCT00004058|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of     12-O-tetradecanoylphorbol-13-acetate in treating patients with hematologic cancer or bone     marrow disorder that has not responded to previous treatment.   "
164629|NCT00004059|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. UCN-01 may increase the effectiveness of a chemotherapy drug by     making tumor cells more sensitive to the drug.      PURPOSE: Phase I trial to study the effectiveness of fluorouracil plus UCN-01 in treating     patients who have advanced or refractory solid tumors.   "
164631|NCT00004061|"     RATIONALE: Biological therapy using growth factors may be effective in reducing side effects     in patients who have hematologic cancer and are receiving radiation therapy, chemotherapy,     and peripheral stem cell transplantation.      PURPOSE: Randomized phase II trial to study the effectiveness of biological therapy to reduce     side effects in patients who are undergoing radiation therapy, chemotherapy, and peripheral     stem cell transplantation in treating lymphoma or leukemia.   "
164632|NCT00004062|"     RATIONALE: Azacitidine may help thyroid cancer cells regain the ability to take up iodine.     This would allow the cancer to be detected and treated by radioactive iodine.      PURPOSE: Phase I trial to study the effectiveness of azacitidine to restore thyroid function     in treating patients who have persistent or metastatic thyroid cancer.   "
164633|NCT00004063|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.     Hyperthermia therapy kills tumor cells by heating them to several degrees above body     temperature. Combining hyperthermia with chemotherapy and interferon alfa may kill more tumor     cells.      PURPOSE: This phase I/II trial is studying the side effects of cisplatin, gemcitabine,     interferon alfa, and whole-body hyperthermia and how well they work in treating patients with     metastatic, recurrent, or refractory cancer.   "
164634|NCT00004064|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy     in treating patients who have ovarian, fallopian tube, or peritoneal cancer.   "
164635|NCT00004065|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of     17-N-allylamino-17-demethoxygeldanamycin in treating patients with refractory advanced solid     tumors or hematologic cancers.   "
164636|NCT00004066|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, docetaxel, and     filgrastim in treating patients who have recurrent or persistent leiomyosarcoma or soft     tissue sarcoma that cannot be removed by surgery.   "
164637|NCT00004067|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel,     use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal     antibodies such as trastuzumab can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. It is not yet known whether     combination chemotherapy plus trastuzumab is more effective than combination chemotherapy     alone for treating breast cancer.      PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy     together with trastuzumab works compared to combination chemotherapy alone in treating women     with node-positive stage II or stage IIIA breast cancer that overexpresses HER2.   "
164695|NCT00005270|"     To map the major genetic loci underlying hypertension in approximately 1700 sibling pairs of     Asian-Pacific Chinese and Japanese origin. The study consists of a two grant network, which     in turn is part of an NHLBI initiative, the Family Blood Pressure Program (FBPP) consisting     of four networks.   "
164638|NCT00004068|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of irinotecan followed by radiation     therapy and temozolomide in treating children who have newly diagnosed brain tumor.   "
164639|NCT00004070|"     Participant with squamous cell cancer of head and neck are invited to participate in this     study. In this study the investigators will be Inserting the gene for interleukin-12 into a     person's cancer cells with the anticipation to make the body build an immune response to kill     more tumor cells.   "
164640|NCT00004071|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known if mitoxantrone and prednisone are more effective with or without leflunomide for     treating prostate cancer.      PURPOSE: Randomized phase II/III trial to compare the effectiveness of mitoxantrone and     prednisone with or without leflunomide in treating patients who have stage IV prostate cancer     that has not responded to hormone therapy.   "
164641|NCT00004072|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining O6-benzylguanine with     carmustine in treating patients who have previously untreated, refractory, or relapsing     multiple myeloma.   "
164642|NCT00004073|"     RATIONALE: Suramin may stop the growth of glioblastoma multiforme by stopping blood flow to     the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining suramin     with radiation therapy may be a more effective treatment for glioblastoma multiforme.      PURPOSE: Phase II trial to study the effectiveness of suramin plus radiation therapy in     treating patients who have newly diagnosed glioblastoma multiforme.   "
164643|NCT00004074|"     Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a     person's white blood cells to kill cancer cells. Monoclonal antibodies such as trastuzumab     can locate tumor cells and either kill them or deliver tumor-killing substances to them     without harming normal cells. Phase I trial to study the effectiveness of interleukin-12 and     trastuzumab in treating patients who have cancer that has high levels of HER2/neu and has not     responded to previous therapy   "
164644|NCT00004075|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of     17-N-allylamino-17-demethoxygeldanamycin in treating patients with solid tumors that cannot     be removed by surgery.   "
164862|NCT00005438|"     To identify those factors that contributed to cognitive deficiencies in children with sickle     cell disease (SCD) who had not demonstrated any overt or clinically apparent neurological     abnormalities.   "
164645|NCT00004076|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of PNU 166148 in treating patients who have     metastatic solid tumors that have not responded to previous treatment.   "
164646|NCT00004077|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, ifosfamide, and     cisplatin in treating patients who have metastatic testicular cancer that has recurred     following treatment.   "
164647|NCT00004078|"     This phase II trial is studying irinotecan to see how well it works in treating children with     refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die.   "
164648|NCT00004079|"     Phase I trial to study the effectiveness of sarcosinamide nitrosourea in treating patients     who have metastatic or unresectable solid tumors. Drugs used in chemotherapy use different     ways to stop tumor cells from dividing so they stop growing or die   "
164649|NCT00004080|"     RATIONALE: Inserting the gene for p53 into a person's brain cells may improve the body's     ability to fight cancer.      PURPOSE: Phase I trial to study the effectiveness of p53 gene therapy with SCH-58500 in     treating patients who have recurrent, or progressive glioblastoma multiforme, anaplastic     astrocytoma, or anaplastic mixed glioma that can be removed during surgery.   "
164650|NCT00004081|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have     ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous     treatment.   "
164651|NCT00004082|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining docetaxel, carboplatin, and     gemcitabine in treating patients who have previously untreated, newly diagnosed epithelial     cancer.   "
164652|NCT00004083|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of liposomal cisplatin in treating     patients who have recurrent ovarian cancer.   "
164653|NCT00004084|"     RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and deliver     cancer-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody     therapy in treating patients who have lymphoma or leukemia that has not responded to previous     chemotherapy.   "
164668|NCT00005005|"     This 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and     alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to     treat osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. We     will treat the study participants either with PTH and alendronate, alendronate alone, or PTH     alone. We will determine the effects of these treatments by looking for changes in bone     mineral density in the hip and spine.   "
164694|NCT00005269|"     To localize, identify, and evaluate common polymorphic variation in genes involved in     determining interindividual differences in blood pressure (BP) levels and essential     hypertension status in three racial groups: African-Americans, Mexican-Americans, and     Non-Hispanic Whites. The study consists of a six grant network, which in turn is part of an     NHLBI initiative, the Family Blood Pressure Program (FBPP) consisting of four networks.   "
164654|NCT00004990|"     This study will test the safety and effectiveness of a monthly dosing regimen of     dexamethasone-a strong steroid medication-to treat patients with focal segmental     glomerulosclerosis (FSGS). Patients with this disease have kidney fibrosis (scarring) and     proteinuria (excessive excretion of protein in the urine) that, in about half of the patients     eventually requires kidney dialysis or transplant. Currently, the most effective treatment     for FSGS is high-dose steroids (prednisone) taken daily for 4 to 6 months. However, only     about 30 percent of patients respond to this treatment, and it causes serious side effects in     many patients. Other drugs, such as cyclosporin and cyclophosphamide, improve proteinuria in     even fewer patients (about 10 percent) and also have serious side effects. This study will     explore whether a monthly pulse dose of steroids will achieve disease remission with less     toxicity.      Adults and children with FSGS who: 1) have not received steroid treatment, or 2) could not     tolerate daily steroid treatment, or 3) relapsed after conventional steroid treatment may be     eligible for this study. Those enrolled will take dexamethasone by mouth for 4 days every 4     weeks for a total of 8 months. Patients will undergo various tests before treatment starts     (baseline), during the course of treatment, and in follow-up visits to evaluate the effects     of treatment as follows:        1. Review of kidney biopsy, medical evaluation, measurement of total daily urine protein          excretion and kidney function, psychiatric testing for depression or other mood disorder        2. Measurements of blood pressure, blood chemistries and urine protein excretion - monthly          during treatment        3. Questionnaire about the effects of treatment, if any, on mood and feelings - monthly          during treatment        4. Photographs of the face and body (in underwear or shorts and tank top) to evaluate body          fat distribution- baseline and 8 months        5. Eye examinations for cataracts and glaucoma - baseline and 8 months        6. Bone density scan (DEXA scan) of the lower spine and hip - baseline, 4 and 12 months        7. Magnetic resonance imaging (MRI) of the hips        8. Psychological evaluation and quality of life evaluation - baseline, 1, 2 and 8 months        9. Blood tests for adrenal gland function - baseline, 4 and 8 months       10. Blood and urine tests - 10, 12, 15, and 18 months      Patients who achieve remission (whose urine protein levels decrease to normal) before     completing the 8 months of dexamethasone will take one more dose and then stop therapy, but     continue with follow-up. Patients who achieve remission but relapse may be offered a second     course of treatment.   "
164660|NCT00004997|"     The 5 q minus syndrome is a condition that occurs due to a missing segment of chromosome 5 in     the normal genetic make-up of the cells responsible for forming blood cells. The condition     causes patients to have the inability to make blood normally. Many patients with this     syndrome need transfusions of red blood cells, platelets, and/or white blood cells. Low     levels of platelets may cause the patient to bleed easily and low levels of whit blood cells     make the patient susceptible to infections. A small number of patients with 5 q minus     syndrome develop leukemia, which is often untreatable with chemotherapy.      Researchers believe that one of the genes missing in 5 q minus syndrome is the gene     responsible for making folic acid active in the body. Folic acid is a vitamin required for     normal blood production.      The purpose of this study to test the effectiveness of a drug called leucovorin for the     treatment of 5 q minus syndrome. Leucovorin is an active form of the vitamin folic acid that     does not require the missing genes to activate it.      Patients participating in this study may or may not improve with leucovorin treatment.     However, the study will improve researchers understanding of the disease and may lead other     potential therapies for the disease.   "
164661|NCT00004998|"     The purpose of this study is to see if two different doses of AG1549 plus other anti-HIV     drugs are safe and effective in HIV-infected patients who are not taking anti-HIV drugs.   "
164655|NCT00004991|"     The purpose of this study is to gain a better understanding of the brain's activity and     organization in the development of speech disorders. It will compare brain activity in people     with normal speech development with those who stutter or who have a phonological disorder (a     deficit in how the brain processes speech sounds).      Stuttering and phonological disorders emerge during the critical period of speech development     between 2.5 and 12 years of age. During this period, the brain is much more adaptable for     speech development than it is after puberty. This study will examine how the brain     organization for speech production and perception develops normally during the critical     period and how the normal pattern is altered when stuttering and phonological disorders     become chronic problems, persisting throughout life.      Volunteer adults and children with and without speech disorders may participate in this     study. Eligibility screening will include a brief neurological and physical examination and     tests to determine normal speech or a speech disorder. The speech testing will be videotaped.     The subject will speak aloud, describe pictures, recall words or numbers, imitate speech     sounds and words, and perform some listening tests.      Study participants will undergo magnetic resonance imaging (MRI) to study brain activity. For     this procedure, the subject lies on a stretcher that is moved into a donut-shaped machine     with a strong magnetic field. During the MRI scan, the subject will perform simple tasks,     such as listening to speech or other sounds and saying nonsense words. The procedure should     take less than 60 minutes, and usually takes from 20 to 40 minutes.   "
164656|NCT00004992|"     The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can     Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or     delayed? The study has recruited 3819 volunteers, who are at high risk of developing     diabetes, at twenty-five medical centers in the United States. It is sponsored by the     National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes     of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy     of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type     2 diabetes in persons with IGT, impaired glucose tolerance. Each person in the study will be     followed for 3 to 6 years.   "
164657|NCT00004993|"     Glucocorticoids are potent anti-inflammatory and immunosuppressive agents. However, prolonged     use of these potent agents results in severe bone loss and osteoporotic fractures.     Parathyroid hormone (1-34), when given as a daily injection has been found to dramatically     increase bone mass in osteoporotic animals and postmenopausal women. The purpose of this     study is to determine whether 2 years of daily PTH (1-34) injections will increase bone mass     and reduce the development of new fractures. In addition, we will follow the study subjects     for 2 more years to determine which type of anti-resorptive agent is required to maintain the     newly formed bone.      We are enrolling postmenopausal women that are on chronic corticosteroid therapy (prednisone     etc.) and have bone loss (osteopenia by DXA) to be a part of this four-year-long study. The     patients will receive two-year therapy with either PTH (1-34) or placebo, and for the second     part of the study subjects receive either estrogen and placebo or alendronate and placebo. We     will measure bone gain by standard bone densitometry, special x-rays of the spine and hip,     and serum and urine bone markers.   "
164658|NCT00004994|"     This study will examine the quality of life of patients undergoing bone marrow     transplantation to treat a blood disease. It will look at how this therapy affects many areas     of life, including for example, personal relationships, work, and general emotional state.     The information gained may lead to improved ways of dealing with problems that may arise     before or during treatment.      Patients receiving bone marrow stem cells donated by a family member may participate in this     study. They will be interviewed before treatment begins and will complete questionnaires at     the following intervals:        1. day of admission to the hospital        2. day of the transplant        3. 30 days after the transplant        4. 100 days after the transplant        5. 1 year after therapy        6. 2 years after therapy      All questionnaires to be completed after discharge from the hospital will be scheduled during     a regular follow-up visit. Each questionnaire takes about 15 to 20 minutes to complete. The     information provided is confidential and will not be shared.   "
164692|NCT00005267|"     To map and identify the major genetic determinants of hypertension and to study possible     interactions between genetic and non-genetic factors in defined populations. HyperGEN     initially consisted of a nine grant network, which in turn is part of an NHLBI initiative,     the Family Blood Pressure Program (FBPP) consisting of four networks.   "
164693|NCT00005268|"     To identify new genetic loci regulating blood pressure in hypertensive rats and in     case-controls from relevant human populations. The study consists of a four grant network,     which in turn is part of an NHLBI initiative, the Family Blood Pressure Program (FBPP)     consisting of four networks.   "
164716|NCT00005291|"     To provide information on morbidity and health care utilization for asthma for a large,     well-defined population over a 20 year period.   "
164659|NCT00004996|"     This study will compare the structure, chemical composition and other characteristics of skin     and blood in people with and without parasitic infections. Cell samples will be taken from     blisters produced by suction blistering. This study may provide new information about the     interactions between parasites and the immune system that could lead to better treatments for     these infections.      Normal volunteers and patients with acute helminth (a type of parasite) infections aged 18     years older may be eligible for this study. Following a medical history and physical exam,     participants will undergo suction blistering to provide cells needed for study. A suction     blister device is attached to the skin of the thigh. A heating element in the device heats     the skin to speed blister formation. (This will feel only a slightly warm.) The device is     removed after about two hours, when the blisters have formed. The blister tops are removed     with sterile scissors. The blistered areas are then treated with special dressings to promote     healing and the participant is discharged with further wound care instructions. A small     amount of blood (around four tablespoons) may be drawn to compare chemicals in the blood with     chemicals in the blister fluid. Participants will be contacted by telephone over the next 72     hours to check on healing. Further follow-up will occur by phone at 6 months and 1 year.      Up to 60 blisters may be produced over a one-year period (in three separate sessions every     six months) with no more than 20 raised per session.   "
164863|NCT00005439|"     To help clarify the validity, reliability, and utility of blood pressure (BP) and lipid     screening in childhood.   "
164663|NCT00005000|"     The purpose of this study is to compare two drugs (nelfinavir [NFV] and efavirenz [EFV]) used     in start-up anti-HIV treatment. Doctors want to see if one is better than the other in     extending the time that viral load (level of HIV in the blood) is kept low. The study will     also look at the response of the immune system to each drug.   "
164664|NCT00005001|"     The purpose of this study is to see if giving HIV-positive patients an HIV vaccine plus     anti-HIV drugs can help lower HIV levels in the blood (viral load).   "
164665|NCT00005002|"     The purpose of this study is to see if it is effective to add an HIV vaccine (Remune) to the     anti-HIV drug combination of Combivir (zidovudine plus lamivudine) and nelfinavir.   "
164666|NCT00005003|"     Some functions are generally controlled by the right side of the brain and others by the     left. One of the most easily observed examples of this lateral specialization of the brain     is handedness-that is, a person's preference for using either the right or the left hand.     This study will try to determine how the genetic component of handedness is inherited. It     will test the theory that a single gene is involved in determining handedness and will try to     locate the gene.      Families with at least two left-handed siblings aged eight years or older and at least one     right-handed parent are eligible to participate in this study.      The left-handed siblings and both parents will fill out a brief questionnaire on hand usage,     obtain a tissue sample taken from inside the cheek, and return the questionnaire and the     sample by mail to the study researchers. The tissue sample will be used for DNA gene mapping.      Participants will be given a kit and instructions for obtaining the sample, along with     mailing envelopes. Cheek swab sampling basically involves using a small brush to gently brush     a layer of cells off of the inner wall of the cheek and then dropping the brush tip into a     preservative.      The information gained from this study may provide insight into aspects of brain development     that can be of medical benefit in the future.   "
164667|NCT00005004|"     This research trial will study discourse processing-that is, how the brain processes the     meaning of language. It will examine, for example, how words and sentences are interpreted in     cases where more than one meaning is possible. The study will include two parts:        1. An investigation of the role of the prefrontal cortex of the brain in discourse          processing will compare test performance of patients with prefrontal cortex damage with          that of healthy age-matched normal volunteers.        2. An investigation of the role of aging in discourse processing will compare test          performance of young healthy subjects (18 to 40 years old) with older healthy subjects          (41 to 80 years old).      All study candidates-both normal volunteers and patients with brain damage-must be at least     18 years old, speak English as their native language, have a high school degree or equivalent     (GED), read on a minimum fourth grade level and be right-handed.      Study candidates who have central nervous system disease, dysfunction or trauma will have a     routine history and neurological examination. They will also undergo neuropsychological     testing if they have not already done so. Patients with neurological damage who have not had     a magnetic resonance imaging (MRI) scan within six months or a year will be asked to undergo     this procedure.      Study participants will take verbal or written tests; sit in front of a computer screen and     press computer keys in response to what they are shown; answer questions from an examiner,     which may be tape-recorded; and fill out questionnaires. There will be rest breaks between     tasks. The studies will be spread over three to four days, with sessions lasting from 30     minutes to three hours.   "
164669|NCT00005006|"     This study investigates the effectiveness of parathyroid hormone (PTH) in combination with     alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are     using alendronate because it may help protect patients against any possible harmful effects     of PTH in cortical bone such as the long bones or hip. We are testing two different treatment     schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of     every 6 months in a cyclical fashion. The entire study is 21 months long; the active     treatment period is 18 months with a 6-month followup period.      The main effects we will look for in this study are changes in body chemicals that are signs     of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We     will randomly assign all study participants, who are women aged 50 and over, to either stay     on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for     3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily     alendronate.   "
164670|NCT00005007|"     This study will determine if the drug etanercept, also called Enbrel, is effective in     producing and maintaining remission (reduction of disease symptoms) of Wegener's     granulomatosis (WG). Etanercept blocks the action of tumor necrosis factor-alpha, a substance     that may be involved in inflammatory conditions such as WG. Eight clinical centers around the     United States will enroll 181 people who have WG. Patients will have an equal chance to     receive either etanercept or placebo (inactive treatment). We will treat patients with     standard medications for WG in addition to either etanercept or placebo. We will treat all     patients with tapering doses of corticosteroids.      After the patients' disease is controlled (in remission), we will reduce the dosages of the     standard medications to lower the risk of side effects associated with these drugs. During     the study, we will collect and save blood and tissues samples from patients and use the     samples to address other medical questions, such as the cause of WG and factors that lead to     disease progression.   "
164671|NCT00005009|"     The purpose of this study is to find out whether Varivax is safe for use in children with     kidney transplants and whether it protects children from serious infection. Varivax is a     vaccine against varicella zoster virus (VZV), the virus that causes chickenpox (varicella)     and shingles (zoster).      Healthy children are already receiving Varivax shots to protect them from chickenpox. Few     children with kidney transplants have received Varivax because doctors have been concerned     that Varivax might cause serious reactions in them. On the other hand, VZV infection can be a     life-threatening disease in these children. For this reason, doctors ultimately want to learn     whether Varivax might safely prevent VZV infections in children who have had kidney     transplants.   "
164743|NCT00005319|"     To develop and apply quantitative methods by which to measure and characterize blood     transfusion practice in specific diagnoses and procedures; to open scientific communication     about transfusion practice within and across institutions; and to develop simpler methods for     estimating annual national blood collections and transfusions.   "
164864|NCT00005440|"     To identify risk factors for work disability among adults with asthma treated by pulmonary     and allergy specialists.   "
164672|NCT00005010|"     The purpose of this study is to see how effective 2 drugs, irbesartan and pravastatin, are at     slowing kidney transplant failure.      Many kidney transplant patients have some type of chronic rejection. Chronic rejection is a     disease that causes scarring and damage to the kidney. Over time, chronic rejection can lead     to kidney failure, making it necessary for patients to start dialysis and possibly receive     another kidney transplant. Doctors would like to see whether irbesartan and pravastatin can     slow this damage and prevent kidney failure in patients with signs of chronic rejection.   "
164673|NCT00005011|"     This study investigates the effects on symptoms of combined treatment with estrogen and     progesterone in women with severe premenstrual syndrome (PMDD).      Studies indicate that women with PMS experience improvement in symptoms following treatment     with leuprolide acetate, when estrogen and progesterone levels are low. Women with PMS, but     not women without the disorder, experience a return of symptoms within approximately a week     after re-exposure to either estrogen or progesterone. The cause of this hormone-induced     depression remains unclear. It is not known whether this depressed mood is due simply to the     change in the levels of estrogen and progesterone and whether it would remit following     continued exposure to stable levels of estrogen and progesterone. This study will determine     whether the maintenance of stable hormone levels will prevent mood disturbances in women with     PMS.      Participants in this study will receive leuprolide acetate injections once a month for up to     6 months. After 2 months, women whose symptoms have improved will receive a skin patch     containing either estrogen or placebo (an inactive substance) and will be asked to take daily     suppositories containing either progesterone or placebo. Women whose symptoms of PMS do not     respond to leuprolide treatment after 2 months will end the study and be offered other     treatment. Participants will be seen by a nurse in the clinic every two weeks and will fill     out ratings and have blood drawn to measure hormone levels.   "
164674|NCT00005012|"     The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to     HIV-infected patients who are not doing well with their current anti-HIV drug combination     (HAART).   "
164675|NCT00005013|"     The purpose of this trial is to study the acute efficacy and safety of a standardized extract     of the herb Hypericum perforatum (St. John's Wort), called hypericum for purposes of this     trial, in the treatment of patients with major depression.      Clinical depression is a serious medical disorder that can be debilitating and can lead to     suicide. There is growing public interest in claims that hypericum may be an effective     treatment for depression. Although it is widely prescribed in Europe, no studies of its     long-term use have been conducted, and published studies have treated different types of     patients and have used several different doses. The toxicity and side effects of hypericum     appear to be substantially less than those of standard tricyclic antidepressant medications,     and thus hypericum may be more acceptable to patients. In addition, the cost is significantly     less than standard antidepressant medications. Published studies assessed acute efficacy and     lasted between 4 and 12 weeks (most being 4-6 weeks). The longer-term effects of hypericum     have not been evaluated. There is a need for a large-scale, controlled clinical trial to     assess whether Hypericum has a significant therapeutic effect in patients with clinical     depression.      Patients are assigned randomly (like tossing a coin) to receive St. John's wort, Sertraline     (Zoloft), or a placebo (sugar pill) for 8 weeks. This is a double-blind study, meaning     neither the patient nor the doctor will know which treatment is being assigned. Patients who     respond well to the treatment will continue on the assigned treatment for an additional 4     months. Patients will have regular follow-up visits to monitor their symptoms and any side     effects they experience.   "
164717|NCT00005292|"     To collect data from the 37 participating clinical centers on patients with     alpha1-antitrypsin deficiency, including those who received replacement therapy with an     intravenous preparation of alpha1-proteinase inhibitor (A1Pi) concentrate.   "
164676|NCT00005014|"     This study is designed to determine the effectiveness of risperidone, a drug treatment for     the interfering symptoms of Autistic Disorder in children and adolescents between the ages of     5 and 17. Between 100 and 120 patients will be participating in this research study at five     academic medical centers in the United States. The primary aim of the treatment is to reduce     impairing behavioral symptoms such as aggression, explosive outbursts, or self-injurious     behavior, without significant side effects. A secondary aim is to evaluate possible     improvement in the level of social relatedness, attention, motor coordination, and short-term     memory.      This study is a placebo-controlled, double-blind study (neither the investigators nor     patients know if the treatment being given is risperidone or an inactive substance, placebo).     Patients will be asked to participate for 6 to 8 months. For the first 8 weeks, patients will     receive either risperidone or placebo, randomly chosen. At the end of the 8 weeks, those     patients who have improved and were on risperidone will be asked to continue on this     medication for another 4 months. The last two months of the study are again double-blind     (neither patients nor investigators know treatment). Patients will either continue     risperidone treatment or be gradually tapered from risperidone (placebo-substitution). This     blinded discontinuation phase will last 2 months during which patients will be closely     monitored for recurrence or worsening of symptoms. Patients who have been treated with     placebo in the first 8 weeks of the study and have not improved will be treated with     risperidone. Weekly visits are required for the first 8 weeks of the study, monthly visits     for the following 4 months, and weekly visits during the last 2 months of the study.   "
164677|NCT00005015|"     THIS STUDY HAS BEEN DISCONTINUED.      The study is designed to evaluate the safety and efficacy of fluoxetine for treating children     and adolescents with Bipolar Disorder who are experiencing an episode of major depression     while being treated with a mood stabilizer. The study involves a 2-week assessment period.     Patients who are on stable, therapeutic doses of lithium or valproate and continue to have     depression will be randomized to a 12-week treatment of fluoxetine or placebo. Those who     respond favorably to treatment will be followed openly for an 18-week continuation phase.   "
164744|NCT00005320|"     To determine the degree to which neuro-psychological performance and general health status     and function may be impaired in subjects with mild and moderate degrees of sleep-related     respiratory disturbances (SRRD), as compared to subjects with minimal apneic activity. Also,     to assess the degree to which improvement may occur following specific treatment.   "
167975|NCT00038246|"     The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all     chemotherapy drugs used in shrinking the cancer.   "
164678|NCT00005016|"     This study will examine the experiences of parents who decided to continue a pregnancy after     receiving a prenatal diagnosis of holopresencephaly (HPE). HPE results from a genetic defect     that can cause facial abnormalities such as cleft lip and cleft palate, learning     disabilities, muscle weakness, problems with digestion, sleep and muscle control, and other     disabilities. The severity of symptoms varies greatly among affected children.      Parents whose child was diagnosed before birth with HPE may be eligible for this study. It     involves a one-time interview that takes from about 45 to 60 minutes. The interview is     conducted either in person or by telephone and consists of three parts, as follows:        1. The experience of receiving the diagnosis of HPE during the pregnancy < includes general          questions such as when and how HPE was diagnosed, what kind of information the parent          received, the parent's reaction to the diagnosis, what genetic counseling, if any, the          parents received, and so forth.        2. Emotional and informational needs < includes questions about the parent's specific          emotional and informational needs from the time of diagnosis until the baby's birth, and          the parent's reactions to support that was given.        3. Questionnaire < includes questions about the parent and his or her child, such as the          parent's age, gender, marital status, and religious background, the child's age, gender,          medical problems, and so forth. The questionnaire will be completed verbally for          telephone interviews and in writing for in-person interviews. The interview will be          tape-recorded and will be kept confidential.      Information from this study will provide health professionals, including genetic counselors,     more effective strategies for helping other parents who face similar prenatal diagnoses.   "
164679|NCT00005017|"     The purpose of this study is to see how effective and safe it is to give 1 of the 3 following     treatments to patients who may not have received anti-HIV treatment: 1) lamivudine     (3TC)/abacavir (ABC)/stavudine (d4T); 2) 3TC/ABC/efavirenz (EFV); or 3) 3TC/ABC/amprenavir     (APV)/ritonavir (RTV).   "
164680|NCT00005255|"     To determine the association between ischemic heart disease incidence and anthropometric     indices of body-fat distribution.   "
164681|NCT00005256|"     To test the hypothesis that the incidence of coronary heart disease and cardiovascular     mortality could be accurately predicted by the presence of coronary calcific deposits     detected by cardiac fluoroscopy.   "
164682|NCT00005257|"     To define the role of dietary variables on changes in plasma cholesterol levels over time in     the Framingham cohort and the Framingham Offspring cohort.   "
164683|NCT00005258|"     To determine genetic mechanisms responsible for congenital cardiovascular malformations.   "
164684|NCT00005259|"     To determine whether the dietary intake of trans-fatty acids derived from partially     hydrogenated unsaturated fatty acids measured through a biomarker are directly associated     with the risk of primary cardiac arrest.   "
164685|NCT00005260|"     To examine the relationships among psychosocial factors and carotid atherosclerosis,     myocardial ischemia, arrhythmias, and thrombosis.   "
164686|NCT00005261|"     To determine whether low total urinary kallikrein activity was prospectively associated with     new hypertension onset or elevated blood pressures.   "
164687|NCT00005262|"     To identify risk factors for idiopathic dilated cardiomyopathy and to examine prognostic     factors over a follow-up period of two to three years.   "
164688|NCT00005263|"     To determine whether postprandial lipoproteins were associated with atherosclerosis, and if     so, whether the association was statistically independent of that between fasting     lipoproteins and atherosclerosis.   "
164689|NCT00005264|"     To conduct a longitudinal, natural history study of cardiovascular disease risk factors in     children. Growth curves were compared for levels of blood pressure, lipids, cardiac     structures and function, and related to physical growth and maturation, nutrient intake,     physical activity, body composition, puberty, and smoking.   "
164690|NCT00005265|"     To examine the natural history of mortality due to coronary heart disease in post-myocardial     infarction patients from the Beta-Blocker Heart Attack Trial (BHAT) and the Aspirin     Myocardial Infarction Study (AMIS).   "
164691|NCT00005266|"     To analyze cardiovascular disease mortality and total mortality in the NAS-NRC Twin Registry     using a new methodology that allowed for censored observations of outcomes, environmental     covariates, and unmeasured genotype-environment interactions.   "
164696|NCT00005271|"     To investigate the relationship between dietary factors, especially macronutrients, and blood     pressure in an international, multicenter observational study. A particular focus is to help     elucidate the role of these dietary factors in accounting for the even more adverse blood     pressure patterns of less educated population strata, especially in the United States, in     both less educated Blacks and whites.   "
164697|NCT00005272|"     To evaluate the relationships between smoking rate, gender, and body weight in the Hispanic     Health and Nutrition Examination I Survey (HHANES) I. Also, to evaluate the independent and     additive contribution of smoking rate and fasting glucose on body weight in HHANES I and     NHANES II.   "
164698|NCT00005273|"     To evaluate the types, incidence, course, and outcome of pulmonary disorders in newly     diagnosed cases of Acquired Immune Deficiency Syndrome (AIDS), newly diagnosed cases of     AIDS-related complex (ARC) and newly diagnosed asymptomatic human immunodeficiency virus     (HIV) infection.   "
164699|NCT00005274|"     To determine the prevalence and natural history of pulmonary and cardiac complications     associated with HIV infection in utero, in infancy, and during early childhood.   "
164700|NCT00005275|"     To test whether sleep-disordered breathing is associated with an increased risk of coronary     heart disease, stroke, all-cause mortality, and hypertension. The multicenter, longitudinal     study draws on existing, well-characterized, and established epidemiologic cohorts.   "
164701|NCT00005276|"     To test specific hypotheses concerning environmental, occupational, lifestyle, and other risk     factors for sarcoidosis. Also, to examine the familial aggregation of sarcoidosis and to test     genetic hypotheses concerning its etiology. Finally, to describe the natural history of     sarcoidosis, particularly in African-Americans who appear to be disproportionately affected,     and to implement a system for storing biological specimens including blood cells, plasma, and     serum.   "
164702|NCT00005277|"     To determine the natural history of sickle cell disease from birth to death in order to     identify those factors contributing to the morbidity and mortality of the disease.   "
164703|NCT00005278|"     To conduct a multicenter epidemiologic study of the human retroviruses HIV-1, HIV-2, HTLV-I,     and HTLV-II in volunteer blood donors from areas of the United States that were reportedly at     high and medium or low risk for HIV. Also, to determine the prevalence of retrovirus     seropositivity in first time blood donors; and the rate of retrovirus seroconversion in     repeat blood donors as a measure of incidence of infection; to ascertain risk factors for     antibody-positive donors; to characterize the blood donor population by geographic location,     age, sex, race/ethnicity, and donation history to permit analysis on prevalence, incidence,     and risk factors; to identify recipients of retrovirus-positive blood units and conduct     clinical and laboratory follow-up of these recipients; and to establish a blood specimen     repository for long-term storage of specimens from study donors and recipients for future     testing.   "
164704|NCT00005279|"     To determine the natural history, etiology, and interrelationships of emphysema, chronic     bronchitis, asthma, and related airways obstructive diseases. Also, to determine the     relationship of acute lower respiratory tract illnesses in infants and children to the     development of subsequent chronic lung disorders.   "
164705|NCT00005280|"     The overall objective of the Center was to develop a scientific data base for the control and     prevention of acute and chronic lung injury caused by the inhalation of a variety of agents     in the workplace and in the environment. There were two epidemiologic studies.      Respiratory Effects of Exposures to Irritant Gases: To collect longitudinal lung function and     symptom data in chemical manufacturing workers who were exposed to chemical irritants such as     ammonia, chlorine, phosgene, isocyanates, sulphur dioxide, nitrous oxide, formaldehyde,     organic acids, hydrochloric acid fluorides, other aldehydes, and acid anhydrides.      Workers in the Cotton Textile Industry: To detect and quantitate the risk for the development     of chronic obstructive airways disease which occurred in workers exposed to cotton dust in     textile manufacturing.   "
164706|NCT00005281|"     To continue to evaluate risk factors heretofore determined to be important predictors of     chronic respiratory symptoms, diagnosis of asthma, and alterations in expected levels of lung     function in children and adolescents in a new population of young adult women.   "
164707|NCT00005282|"     From 1981 to 1991, to characterize the role of allergy and airways responsiveness in     modifying growth of lung function in children and young adults in a community-based random     population, the Childhood Respiratory Study in East Boston. From 1992 to 1997, to examine the     relationship of respiratory symptoms and illnesses, cigarette smoking, airways     responsiveness, and markers of inflammation to growth and decline in lung function in two     well-characterized and investigated community-based populations of children and adults, the     Childhood Respiratory Study in East Boston and the Normative Aging Study.   "
164708|NCT00005283|"     To identify risk factors which predispose individuals to develop asthma and other     manifestations of allergic disease on exposure to laboratory animals in the workplace.   "
164709|NCT00005284|"     To prospectively identify factors that influence the rate of decline in pulmonary function     and to identify predictors of chronic obstructive lung disease (COLD) and asthma in a     population sample of older adults.   "
164710|NCT00005285|"     To determine factors, including maternal cigarette smoking and acute respiratory illness,     influencing infant lung function at birth and up to five years of age.   "
164711|NCT00005286|"     To define the prevalence of Sleep Apnea Syndrome (SAS) in a community-based sample of     Hispanic adults.   "
164712|NCT00005287|"     To measure the cardiopulmonary function in individuals who developed bronchopulmonary     dysplasia (BPD) at Stanford University Medical Center from 1964-1973 and to determine the     factors associated with the presence of cardiopulmonary function abnormalities in these     adolescents and young adults.   "
164713|NCT00005288|"     To characterize the nature of pulmonary responses to organic dust exposures in order to gain     insight into patterns of respiratory disease in agricultural workers.   "
164714|NCT00005289|"     To investigate risk factors in bronchopulmonary dysplasia (BPD) and to elucidate the     relationship between BPD, acute lung disease severity, respiration-related variables, water     balance, nutrition, familial predisposition, and environmental, pregnancy, and delivery     parameters.   "
164715|NCT00005290|"     To establish a population-based registry of interstitial lung disease in Bernalillo County,     New Mexico.   "
164733|NCT00005308|"     To estimate the risk of death for patients with different pre- and post-operative hemoglobin     levels who do not receive blood transfusions and to derive a multivariate model using     clinical information available pre-operatively that would predict the risk of death     post-operatively.   "
164734|NCT00005309|"     To examine mechanisms of individual differences in the progression of HIV infection in     hemophiliacs.   "
164735|NCT00005311|"     To develop a comprehensive database publication (databook) utilizing available published and     unpublished data on the prevalence of hypertension and its treatment and control in selected     minority populations in the United States -- Hispanic, Asian and American Indian.   "
164736|NCT00005312|"     To continue the work of the Collaborative Studies Coordinating Center (CSCC) on international     studies in cardiopulmonary disease epidemiology. The work was being performed under bilateral     agreements that the NHLBI had entered into with Russia, The People's Republic of China and     Pakistan. The contract provided nutritional, epidemiologic and biostatistical services in     support of these studies.   "
164737|NCT00005313|"     To conduct focused studies of lipoprotein physiology and pathophysiology in genetically     characterized patients with the objectives of understanding disease mechanisms, developing     better treatments, and identifying and preventing early vascular disease.   "
164738|NCT00005314|"     To elucidate the role of biobehavioral factors in the etiology, pathogenesis and course of     coronary heart disease (CHD) and to use this knowledge to devise more effective prevention,     treatment and rehabilitation approaches.   "
164739|NCT00005315|"     To evaluate the role of psychosocial factors in the development of hypertension and     cardiovascular disease.   "
164740|NCT00005316|"     To investigate the mechanisms of white coat hypertension and study it further as a risk     factor for heart damage.   "
164741|NCT00005317|"     To conduct cross-sectional and longitudinal studies of patients with idiopathic pulmonary     fibrosis (IPF) and patients with progressive systemic sclerosis (PSS), with and without     associated lung disease.   "
164752|NCT00005328|"     To identify the early emergence and stability of children's hostile behaviors and their     associated psychophysiological responses to behavioral challenges, which are possible risk     factors for cardiovascular diseases in adulthood; and to specify their determinants and     consequences.   "
164753|NCT00005329|"     To test the hypothesis that low levels of free protein S, a natural anticoagulant protein in     plasma, were associated with an increased incidence of myocardial infarction in middle aged     men and women.   "
164754|NCT00005330|"     To identify early childhood determinants of eating and exercise behaviors that relate to     cardiovascular disease.   "
164755|NCT00005331|"     To conduct a randomized controlled smoking prevention trial to evaluate quality of     implementation and effectiveness, as a function of provider type (school teacher vs. nurse)     and training (mediated vs. interactive).   "
164756|NCT00005332|"     To investigate drug-gene interactions on the incidence of non-fatal myocardial infarction and     stroke for hypertensive patients.   "
164757|NCT00005333|"     Originally from 1991 to 1991, to test the hypothesis that differences in hypertension     prevalence in Nigerian workers were primarily related to differences in socioeconomic status     (SES). At renewal in 1996, to determine the importance of weight gain and weight-related     factors in blood pressure.   "
164758|NCT00005334|"     To study the personality and environmental factors that may determine the short-term and     long-term sequelae of coronary artery bypass surgery (CABS).   "
164759|NCT00005335|"     To determine the contribution of polymorphic variation in candidate genes involved in lipid     metabolism in determining quantitative lipoprotein-lipid levels and cardiovascular risk     factors in Anglo and Hispanic populations of the San Luis Valley in southern Colorado. The     candidate genes included those for A-IV, B, D, E, H, APO(a), LDL receptor, hepatic lipase,     lipoprotein lipase, lethicin cholesterol acyletransferase (LCAT), and cholesteryl ester     transfer protein.   "
164760|NCT00005336|"     To conduct a dietary intervention trial to test the lipid lowering response to the National     Cholesterol Education Program (NCEP) Step Two Diet by free-living hyperlipidemic women and     men and to compare the response between them.   "
164762|NCT00005338|"     In the first phase, to establish the relationship of progression of peripheral vascular     disease (PVD) to plasma homocysteine. In the second phase, to conduct a randomized,     controlled trial of folic acid treatment of plasma homocysteine in peripheral vascular     disease.   "
164763|NCT00005339|"     To determine the risk of transfusion-transmitted hepatitis C virus (HCV) in cardiac surgery     patients before and after donor screening for anti-HCV and surrogate markers of non-A, non-B     hepatitis (NANBH). Also, to characterize donors who were HCV seronegative and who lacked     surrogate markers at the time of donation, but whose recipient seroconverted to HCV.   "
164764|NCT00005340|"     To continue an international collaborative study on hypertension in populations of West     African origin.   "
164765|NCT00005341|"     To determine if there were immune sequelae related to the long-term donation of blood or     blood products.   "
164766|NCT00005342|"     To investigate the differences in diet, fat cell morphology and lipoprotein metabolism in     previously- overweight and naturally lean men and women who ran and who lived sedentary     lifestyles in order to better understand the relationship between lipoprotein metabolism and     weight set-point.   "
164767|NCT00005343|"     To examine the mechanism through which social support affects morbidity and mortality from     coronary heart disease.   "
164768|NCT00005344|"     To determine prospectively the extent to which structural and functional aspects of social     support influences 'hard' cardiac events such as death and non-fatal myocardial infarction in     patients with coronary artery disease (CAD) and to identify the behavioral and biological     mediators of these influences.   "
164769|NCT00005345|"     To conduct a genetic epidemiologic study of the coronary heart disease (CHD) risk factors of     blood lipids and obesity in Black and white girls who participated in the NHLBI-supported     National Growth and Health Study (NGHS). The study was ancillary to NGHS.   "
164770|NCT00005346|"     To understand the mechanism(s) underlying sodium-dependent blood pressure control, and to     determine the consequences thereof.   "
164771|NCT00005347|"     To examine the associations between diet, nutrition and coronary heart disease (CHD)     incidence over seven years using the Cycle V Framingham Offspring/Spouse examination ; to     examine the cross-sectional associations between dietary variables and major cardiovascular     disease risk factors, to examine changes in dietary behaviors and their determinants over     seven years; and to characterize the influences of dietary behavior changes on risk factor     status between 1984-88 and 1991-94.   "
164772|NCT00005348|"     To relate distribution of adipose tissue measured by a then new imaging technique, Magnetic     Resonance Imaging (MRI) to extracranial carotid atherosclerosis, cardiovascular disease risk     factors, and to more conventional measures of fat distribution such as body mass index (BMI)     and waist/hip ratio. The primary hypothesis was that patients with extracranial carotid     atherosclerosis (cases) had more intra-abdominal fat and a higher ratio of intra-abdominal     fat to total or subcutaneous fat than age-sex-race matched controls.   "
164773|NCT00005349|"     Using subjects from the Rochester Family Heart Study (RFHS), to characterize predictors of     coronary artery calcification (CAC), a potent marker of atherosclerosis, among individuals     from the general population.   "
164774|NCT00005350|"     To determine the cost-effectiveness of alternative strategies for cholesterol reduction.   "
164775|NCT00005351|"     To identify the incidence cohort of Olmsted County Minnesota residents with deep venous     thrombosis (DVT)/pulmonary embolism (PE) from 1966 through 1990. Episodes of DVT or PE     acquired during hospitalization or in the community were identified for future studies.   "
164776|NCT00005352|"     To conduct a prospective, longitudinal, analysis of the psychophysiological effects of     chronic exposure to environmental stress. The study took advantage of a unique, naturally     occurring experiment caused by the relocation of a major international airport.   "
164777|NCT00005353|"     To establish the incidence, clinical spectrum, and natural history of cardiac dysautonomia as     defined by heart rate spectral analysis in both HIV infected and noninfected children and to     evaluate the value of heart rate spectral analysis for predicting dysrhythmias and sudden     death in infants and children born to HIV infected mothers.   "
164778|NCT00005354|"     To investigate the relationship between coronary heart disease risk factors and coronary     artery calcification in middle age adults from the Muscatine Study. From 1992 through 1995,     ultrafast computed tomography was used to measure coronary artery calcification. The study     has been extended through January, 2001 in order to examine the role of electron beam     computed tomography in detecting the presence and quantity of coronary artery calcification,     a marker of the atherosclerotic process.   "
164779|NCT00005355|"     To develop, test, and apply comprehensive mathematical models for the interaction of genetic     and environmental effect on cardiovascular risk with gender differences.   "
164780|NCT00005356|"     To investigate hemostatic variables in relation to cardiovascular risk in the Framingham     Offspring Study cohort.   "
164781|NCT00005357|"     To establish a registry of primary pulmonary hypertension (PPH), a lethal disease which     causes progressive obstruction of small pulmonary arteries and to investigate basic     mechanisms of the disease.   "
164782|NCT00005358|"     To determine if selected circulating blood factors that reflect enhanced thrombogenesis are     associated with an increased incidence of recurrent coronary events, including cardiac death     or non-fatal myocardial infarction.   "
164783|NCT00005359|"     To investigate the genetics of asthma by reexamining a carefully characterized population of     patients with asthma, and by studying their families.   "
164784|NCT00005360|"     To assess, in donor-recipient clusters, current models of HIV-1 genetic evolution and     pathogenesis, based on the sequence diversity displayed by this lentivirus.   "
164785|NCT00005361|"     To measure lung function and respiratory symptom status in a large cohort of healthy,     non-smoking 18-22 year old subjects, and relate these measurements to past histories of     passive smoke and air pollution exposures.   "
164786|NCT00005362|"     To modify and expand an existing pharmacokinetic model for nasal dose as well as to develop a     new model to estimate tracheobronchial dose of an active agent for each subject in a study of     acute respiratory health effects.   "
164787|NCT00005363|"     To continue a prospective study of the ability of ambulatory blood pressure to predict     cardiovascular morbidity in patients with mild hypertension.   "
164789|NCT00005365|"     To conduct a longitudinal study of central obesity and related risk factors found to be     associated with hypertension and atherosclerotic cardiovascular disease (ASCVD) in a     previously-examined cross-sectional cohort of second-generation Japanese Americans and in a     newly-recruited cohort of third generation Japanese Americans.   "
164790|NCT00005366|"     To investigate the role of biobehavioral factors in the pathogenesis of concentric left     ventricular hypertrophy.   "
164791|NCT00005367|"     To conduct a cross-sectional epidemiologic study of the determinants of prolonged heart rate     corrected QT interval (QTc) among 300 men and 300 woman in the population with the highest     known risk of SUDS: Southeast Asian refugees in Thailand. .   "
164792|NCT00005368|"     To determine prospectively the role of elevated plasma triglyceride (TG) as a risk factor for     20-year coronary heart disease (CHD) mortality in familial combined hyperlipidemia (FCHL) and     familial hypertriglyceridemia (FHTG), the familial forms of hypertriglyceridemia. Also, to     perform genetic epidemiologic studies of recently identified lipoprotein risk factors for     CHD, including Atherogenic Lipoprotein Phenotypes (ALP) based on subclasses of low-density     lipoproteins (LDL), Lipoprotein(a) (Lp(a)) and apolipoprotein (apo) B plasma levels, and apo     E isoforms.   "
164793|NCT00005369|"     To examine whether differences existed between asymptomatic white and African Americans known     to be at high risk for premature coronary artery disease (CAD) in risk factor distributions,     prevalence of occult coronary disease, and mechanisms of coronary disease expression.   "
164794|NCT00005370|"     To conduct a longitudinal study of the relationship between the rate of decline of pulmonary     function and measurements of cortisol concentration and excretion in a sample of middle-aged     and older men and their wives. The study tested the hypothesis that persons whose plasma     cortisol concentrations were relatively low, albeit within the normal range, were predisposed     to excessively rapid deterioration of pulmonary function during aging.   "
164795|NCT00005371|"     To use the Multiple Risk Factor Intervention Trial (MRFIT) stored serum bank to do nested     case-control studies of various serum risk factors in coronary heart disease incidence and     mortality.   "
164796|NCT00005372|"     To investigate the role of serum and dietary antioxidants, serum pro-oxidants, and smoking on     the progression/regression of carotid intima-media thickness (IMT).   "
164797|NCT00005373|"     To study mechanisms of excess coronary ischemia secondary to alterations in autoregulation     and arteriolar vasoreactivity in Black Americans with hypertension, varying degree of left     ventricular hypertrophy, and angiographically normal or mildly diseased coronary arteries.   "
164798|NCT00005374|"     To investigate the genetic influence of candidate gene polymorphisms on risk factors for the     metabolic insulin resistance syndrome in Japanese American sibships and kindreds. The     original grant in 1994 had as its objective to understand the genetic epidemiology of     coronary heart disease (CHD) risk factors in Japanese- American families with probands living     in Seattle, Washington.   "
164799|NCT00005375|"     To conduct a prospective study of the determinants of smoking onset in adolescents attending     Memphis City Schools and to determine the unique predictors of smoking onset in Black versus     white adolescent females.   "
164800|NCT00005376|"     To establish in children born prematurely a set of links between lung function in late     infancy and lung function at school age, between lung function at school age and that in     adolescence, and between lung function in adolescence and that in adulthood in order to     evaluate pulmonary outcomes of neonatal therapeutic strategies and to relate these strategies     to lung health in adult life.   "
164801|NCT00005377|"     To localize individual genes, called blood pressure quantitative trait genes [BPQTGs], which     influence blood pressure levels in the population-at- large, and to determine if these genes     are able to predict the occurrence of essential hypertension or coronary artery disease.   "
164802|NCT00005378|"     To test the hypothesis that clinically inapparent sleep-disordered breathing was associated     with blood pressure elevation, impairment of health-related quality of life, and depression.   "
182990|NCT00237861|"     This study will compare the effectiveness of newer atypical antipsychotics versus older     conventional antipsychotics in treating schizophrenia.   "
164803|NCT00005379|"     To determine the incidence of tuberculosis in an inner city population, identify risk factors     for TB, describe the natural history in adults and children, evaluate the effect of     Mycobacterium tuberculosis (Mtb) co-infection on the progression of human immunodeficiency     virus disease, and determine factors that contribute to compliance and non-compliance with     prophylaxis and treatment.   "
164804|NCT00005380|"     To distinguish whether the observed gender differences in plasma insulin and insulin     resistance reflect biologic differences, or whether the gender differences in insulinemia are     determined by greater adiposity in women. Also, to determine if the hyperinsulinemia per se     contributes to excess risk for cardiovascular disease in African American women. Finally,     since higher androgenicity is linked with cardiovascular risk in women, to determine if the     risk factors associated with hyperinsulinemia are modulated by sex hormones.   "
164805|NCT00005381|"     To identify the prevalence of sleep apnea (SA) in women and its relationship to age; to     predict those women at risk for sleep apnea; and to define the natural history of those with     sleep apnea.   "
164806|NCT00005382|"     To provide information necessary for the development of standards for peak expiratory flow     (PEF) test performance in populations studies.   "
164807|NCT00005383|"     To examine anger and cardiovascular disease risk in urban youth. The project studied patterns     of hemodynamic responses to social and nonsocial stressors, ambulatory blood pressure (BP),     fasting insulin, fasting glucose, lipid profiles, and central obesity in adolescents from a     wide range of socioeconomic status (SES) backgrounds.   "
164808|NCT00005384|"     To perform a follow-up study of physical activity and dietary behaviors and their     determinants in 10- to 11-year-old Anglo and Mexican-American children from low- and     middle-socioeconomic status (SES) families who were studied initially when they were 4 to 7     years old.   "
164809|NCT00005385|"     To describe and delineate in a prospective study the nature and causes of seasonal variation     of blood lipid levels in the general population.   "
164810|NCT00005386|"     To examine the biobehavioral determinants of obesity in Black as compared with white women.   "
164811|NCT00005387|"     To investigate the genetic determinants of hypertension in three populations of the African     diaspora, with a major focus on clarifying the role of genes that code for the     renin-angiotensin system (RAS).   "
164812|NCT00005388|"     To measure visceral (intraabdominal) fat by computerized tomography (CT) scan and to measure     resting metabolic rate by indirect calorimetry in 400 CARDIA subjects, ages 28-40 years (100     of each race/gender group) from the Oakland, California and Birmingham, Alabama centers.   "
164813|NCT00005389|"     To evaluate the safety of calcium-channel blockers in the secondary prevention of myocardial     infarction in women.   "
164814|NCT00005390|"     To examine the role of family processes in asthma regulation in three groups of children with     mild to moderate asthma.   "
164815|NCT00005391|"     To establish and maintain a national registry of children with different forms of     cardiomyopathy.   "
164816|NCT00005392|"     To conduct several studies on the epidemiology of venous disease.   "
164817|NCT00005393|"     To measure serum concentrations of alpha tocopherol, selenium and all major carotenoids     (alpha- and beta- carotene, lutein, (beta-cryptoxanthin and lycopene) in Black and white,     male and female, high and low education individuals aged 18-30 in 1985-86. In subsequent     renewals additional markers of oxidative stress and endothelial dysfunction have been     measured in blood collected 7 to 30 years after baseline.   "
164818|NCT00005394|"     To identify and study a large cohort of glucocorticoid remediable aldosteronism (GRA)     patients.   "
164819|NCT00005395|"     To clarify the relationship of the arterial lesions to aging, define the influence of the     arterial changes on the development of stroke, brain infarction, and dementia, and provide a     better understanding of vascular dementia.   "
164820|NCT00005396|"     To evaluate the efficacy of a motivational intervention designed to reduce children's     exposure to environmental tobacco smoke in the household and to increase parental motivation     towards smoking cessation.   "
164821|NCT00005397|"     To examine the relationship of risk factors measured in childhood to intimal medial thickness     (IMT) in early adulthood and to examine familial factors which may be related to increased     IMT, a measure of atherosclerosis.   "
164822|NCT00005398|"     To continue surveillance of the participants in the University of North Carolina Alumni Heart     Study, which tests the hypothesis that hostility and related psychosocial factors are     involved in the pathogenesis of coronary heart disease.   "
164823|NCT00005399|"     To examine factors affecting heart rate variability (HRV) and the role of HRV in heart     disease. Specifically, to examine the role of HRV: as a predictor of fatal and nonfatal     ischemic heart disease over a six year follow-up of the Atherosclerosis Risk in Communities     (ARIC) population based, bi-ethnic cohort; on the six year progression of carotid     atherosclerosis measured by B-mode ultrasound; and on the incidence of hypertension. Also, to     study the effect of elevated fasting insulin, glucose, diabetes mellitus, and other metabolic     abnormalities on changes in HRV over nine years of follow-up.   "
164824|NCT00005400|"     To examine angiotensinogen genetic variants and adverse pregnancy outcomes.   "
164825|NCT00005401|"     To determine whether objectively recorded sleep durations were mortality risk factors,     whether sleep duration could be distinguished from depression as a risk factor in Women's     Health Initiative (WHI) data, and whether sleep-associated risks were attributable to     specific pathophysiologic processes such as sleep apnea, circadian rhythm phase advances, or     deficiencies of melatonin, or deficiencies of reproductive steroids. The study was ancillary     to the WHI.   "
164826|NCT00005402|"     To identify a large cohort of children transfused in the decade prior to second-generation     anti-hepatitis C virus (HCV) donor screening (1982-1992). This will not only identify cases     for the study of persistent infection and chronic hepatitis in children, but will allow for     the determination of the annualized risk of transfusion-associated hepatitis (TAH) infection     in children, data that are not currently available.   "
164865|NCT00005441|"     To develop and evaluate a comprehensive lifestyle self-management (CLSM) program (low-fat     vegetarian diet, smoking cessation and stress management training) for postmenopausal women     with coronary heart disease and Type II (non-insulin dependent) diabetes.   "
164827|NCT00005403|"     To utilize national population data sets prepared by the National Center for Health     Statistics, to (1) examine the current Black disadvantage in cardiovascular (CV) health, (2)     explore potential clinical and epidemiologic causes, (3) incorporate emerging knowledge of     new risk factors and (4) compare trends in medical treatment and risk factors for the four     sex-race groups.   "
164828|NCT00005404|"     To evaluate the relationships of compliance in taking aspirin or aspirin placebo with the     risk of major cardiovascular endpoints, using data collected in the Physicians' Health Study.   "
164829|NCT00005405|"     To analyze the relationships between parity (childbirth) or gravidity (pregnancy) and     measures of lipids in groups of women from the Hispanic Health and Nutrition Examination     Survey (Hispanic HANES) and the Framingham Heart Study.   "
164830|NCT00005406|"     To prospectively examine changes in lipids, lipoproteins, and blood pressure among 295 young     adults who had been followed for sixteen years in the Beaver County Lipid Study. The Beaver     County Lipid Study tracked the cholesterol values of 295 children, ages 11 to 14 at baseline.   "
164831|NCT00005407|"     To define pediatric sex-specific blood pressure percentiles that were a function of both age     and height. Also, to define the precise age at which blood pressure distributions for     different racial groups diverged.   "
164832|NCT00005408|"     To reanalyze data on risk factors for cardiovascular disease (CVD) including total     cholesterol and high density lipoprotein (HDL) cholesterol for the subjects in the first,     second, and third exams of the NHLBI Twin Study.   "
164833|NCT00005409|"     To study further the association between blood pressure mortality among those who     participated in both the Hypertension Detection and Follow-up Program (HDFP) screen and the     East Boston Established Populations for Epidemiologic Studies in the Elderly (EPESE) study.   "
164834|NCT00005410|"     To conduct an analysis of the epidemiology of coronary heart disease (CHD) in Blacks using     data collected from the 'Survival and Ventricular Enlargement (SAVE) Following Myocardial     Infarction' study.   "
164835|NCT00005411|"     To continue analysis of data from a longitudinal study of 246 urban Black preschool children     and their families in order to identify the long-term effects of social and environmental     influences on nutrition and activity and the consequences of these influences for the     children's cardiovascular disease (CVD) risk status.   "
164836|NCT00005412|"     To examine the role of dietary antioxidants in the etiology of atherosclerosis in both sexes     and in whites and Blacks.   "
164837|NCT00005413|"     To investigate stroke risk using the National Academy of Sciences Twin Registry.   "
164840|NCT00005416|"     To analyze data collected over a four year period on an initial cohort of 3 or 4 year old     children and their parents in Galveston, Texas, and in Augusta, GA, in regard to     cardiovascular disease (CVD) physical risk factors and risk related behaviors.   "
164841|NCT00005417|"     To seek predictors of mortality, hospitalization, and dialysis using data from a hypertensive     population which began treatment in 1974.   "
164842|NCT00005418|"     To provide a comprehensive analysis of risk factors for the development of clinical     cardiotoxicities in over 6,000 children with cancer who had been treated on standardized     protocols involving the use of anthracyclines alone or in combination with other potentially     cardiotoxic therapies or with no use of anthracycline therapy.   "
164843|NCT00005419|"     To study the influences of physical activity on the incidence of hypertension,     non-insulin-dependent diabetes (NIDDM), and coronary heart disease (CHD), taking into account     the influences of other life-style elements such as body size, cigarette habit, alcohol     consumption habits, and parental history of disease on these same chronic diseases.   "
164844|NCT00005420|"     To develop an integrative predictive model of long-term quality of life in cardiovascular     disease that emphasized adaptive processes and outcomes.   "
164845|NCT00005421|"     To extend analyses of blood pressure (BP) tracking to a period that spanned childhood and     young adulthood. Data were used from the same cohort of 339 children who had been followed     for nine to twelve years in a previous study.   "
164846|NCT00005422|"     To conduct a longitudinal investigation of early childhood lower respiratory illness (LRI)     and patterns of lung growth using an existing electronic dataset generated by an 18-year     study (1972-1990) of a population of 102 Black children followed from birth at the Frank     Porter Graham Child Development Center.   "
164847|NCT00005423|"     To examine dietary quality and subsequent cardiovascular disease (CVD).   "
164848|NCT00005424|"     To determine the effect of widowhood on cardiovascular disease.   "
164849|NCT00005425|"     To determine the effects in early adulthood of asthma, increased bronchial responsiveness,     markers of allergy and smoking on pulmonary function level and the effects of these same risk     factors on subsequent decline in pulmonary function, because these early adult factors     presumably profoundly influence the risk for chronic obstructive pulmonary disease.   "
164850|NCT00005426|"     To assess the influence of HDL-subclasses with coronary disease progression, and to identify     factors influencing HDL subclasses at baseline and over time.   "
164851|NCT00005427|"     To analyze previously collected data on respiratory illness in early childhood.   "
164852|NCT00005428|"     To perform data analyses on the familial aggregation of the stress response as it relates to     hypertension.   "
164853|NCT00005429|"     To examine clinical cardiovascular outcomes of African Americans.   "
164854|NCT00005430|"     To determine and compare the long term (thirty year) relationship of total cholesterol and     mortality in Blacks and whites in a predominantly urban Charleston, South Carolina cohort and     a predominantly rural Evans County, Georgia cohort with special emphasis on the investigation     of the association of low cholesterol to all cause, cardiovascular disease (CVD), and non-CVD     mortality.   "
164855|NCT00005431|"     To use data from the Epidemiologic Follow-up Study of the National Health and Nutrition     Examination Survey (NHANES) to develop models to predict morbidity and mortality as a     function of risk factors for coronary artery disease. Bivariate dependent survival     distributions were examined.   "
164856|NCT00005432|"     To identify what happened to specific groups of newborns after surfactant was introduced to     the market. Were the same benefits with regard to morbidity, mortality, and resource use in     evidence post treatment investigational new drug (IND)?   "
164870|NCT00004358|"     OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of     calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact     parathyroid hormone levels in patients with tumoral calcinosis.      II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether     hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus.      IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone     metabolism in osteopenic patients with tumoral calcinosis.   "
164871|NCT00004359|"     OBJECTIVES: I. Evaluate immunomodulation with extracorporeal photochemotherapy (ECP) in     patients with epidermolysis bullosa acquisita.      II. Investigate the effect of ECP on lymphocyte activity.   "
164872|NCT00004360|"     OBJECTIVES:      I. Determine the relationship between genotype variations and clinical phenotype in patients     with congenital nephrogenic diabetes insipidus.   "
164873|NCT00004361|"     OBJECTIVES: I. Identify latent hypoparathyroidism in normocalcemic adult survivors with     repaired conotruncal cardiac defects, by evaluating parathyroid gland secretory function     after induced hypocalcemia.      II. Determine the relationship of parathyroid hormone secretion to microdeletions in the same     region of chromosome 22q11 as found in patients with DiGeorge anomaly.   "
164874|NCT00004363|"     OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II     (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by     directing the production of an abnormal preprohormone.      II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys     magnocellular neurons because it cannot be folded and processed efficiently.   "
164875|NCT00004364|"     OBJECTIVES:      I. Define the phenotype and genotype of previously unrecognized types of familial diabetes     insipidus (FDI) in kindreds with atypical or novel forms of FDI.   "
164876|NCT00004365|"     OBJECTIVES: I. Assess pituitary size and anatomic configuration by magnetic resonance imaging     (MRI) in 4 affected dwarfs in the province of Sindh, Pakistan.      II. Evaluate ultradian growth hormone (GH) secretory patterns in 4 affected dwarfs.   "
164877|NCT00004366|"     OBJECTIVES:      I. Evaluate whether vestibular rehabilitation training is of value in reducing anxiety     symptoms in patients with panic disorder with or without agoraphobia who have vestibular     dysfunction as identified by clinical vestibular tests.   "
164878|NCT00004367|"     OBJECTIVES: I. Determine whether the prevalence of abnormalities on clinical vestibular     (balance) tests is higher in panic disorder with agoraphobia than in uncomplicated panic     disorder and nonpanic anxiety disorder.      II. Determine whether the prevalence of abnormalities on audiological tests of cochlear or     brainstem function is elevated in panic disorder without agoraphobia or nonpanic anxiety     disorder.      III. Determine whether symptom patterns can be identified that are indicative of vestibular     abnormalities in panic disorder.      IV. Determine whether vestibular dysfunction can be induced by psychosomatic mechanisms.   "
164879|NCT00004368|"     OBJECTIVES:      I. Investigate the efficacy and safety of colchicine therapy in improving hepatic function     and reducing hepatic fibrosis (scarring) in children with hepatic cirrhosis.   "
164880|NCT00004373|"     OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication     behavior in anxious patients with varying histories of using other drugs.      II. Establish outpatient methods for the study of self-medication and drug reinforcement in     patients vulnerable to prescription drug abuse or dependence.      III. Evaluate the influence of alcohol and other non-prescription drug use as determinants of     vulnerability in these patients.      IV. Identify personality, attitudinal, or other variables that might predict different     patterns of self-medication.      V. Assess the effects of cognitive-behavioral therapy on alprazolam self-medication.   "
164881|NCT00004374|"     OBJECTIVES: I. Analyze prospectively the course of amyloid deposition in patients with     primary, secondary, myeloma-associated, and hereditary amyloidosis.      II. Determine abnormalities of humoral and delayed-type hypersensitivity in these patients.      III. Identify prognostic factors in hereditary amyloidosis and develop tests for genetic     defects associated with systemic amyloidosis.      IV. Diagnose familial amyloidotic polyneuropathy (FAP) prior to symptom onset. V. Validate     the correlation of low serum prealbumin and retinol binding protein levels with amyloidosis     in patients with FAP.   "
164882|NCT00004375|"     OBJECTIVES:      I. Evaluate the mechanisms of ultraviolet A-1 light therapy in patients with systemic lupus     erythematosus and normal controls.   "
164883|NCT00004376|"     OBJECTIVES:      I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children     and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit     hyperactivity disorder.   "
164884|NCT00004378|"     OBJECTIVES: I. Ascertain whether stem cell transplantation (SCT) is an effective method by     which missing or dysfunctional enzymes can be replaced in patients with various inborn errors     of metabolism.      II. Determine whether clinical manifestations of the specific disease may be arrested or     reversed by this treatment.   "
164885|NCT00004380|"     OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's     phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic     sclerosis (scleroderma).      II. Determine whether relaxin decreases collagen production by fibroblasts in vivo and     cultured from skin biopsies.   "
164886|NCT00004381|"     OBJECTIVES: I. Compare the efficacy of preventive vs. therapeutic tin mesoporphyrin in direct     Coombs' test-positive ABO hemolytic disease of the newborn and glucose-6-phosphate     dehydrogenase deficiency in infants living in Greece.      II. Assess the safety of tin mesoporphyrin in high-risk newborns.   "
164887|NCT00004382|"     OBJECTIVES: I. Compare the effectiveness of a single dose of tin mesoporphyrin and special     blue light phototherapy in controlling hyperbilirubinemia in premature newborns in Greece.      II. Evaluate the dose of tin mesoporphyrin sufficient to alleviate the need for phototherapy     without adverse effects in these newborns.   "
164888|NCT00004386|"     OBJECTIVES:      Evaluate the safety and feasibility of administering recombinant adenovirus containing the     ornithine transcarbamylase gene to adults with partial ornithine transcarbamylase deficiency.   "
164889|NCT00004387|"     OBJECTIVES:      I. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's     disease.   "
164890|NCT00004390|"     OBJECTIVES: I. Determine whether opioid (morphine) treatment results in better management of     pain than treatment with tricyclic antidepressant (nortriptyline).      II. Assess the effects the two treatments have on affective and cognitive functions.      III. Determine whether the presence of psychiatric comorbidity, particularly depression, can     predict the outcome of the two treatments.   "
164891|NCT00004392|"     OBJECTIVES: I. Assess and compare the incidence and severity of cardiorespiratory events     documented by home monitoring in infants at increased epidemiological risk for sudden infant     death syndrome (SIDS).      II. Determine the antecedent medical, demographic, physiologic, and behavioral     characteristics that predict the incidence of cardiorespiratory events documented by home     monitoring.   "
164892|NCT00004393|"     OBJECTIVES: I. Conduct a randomized, double blind, placebo controlled, parallel study of the     atypical neuroleptic risperidone (RIS) in the treatment of children and adults with moderate     to severe Tourette Syndrome.      II. Evaluate further the safety of RIS in this population.   "
164893|NCT00004396|"     OBJECTIVES: I. Compare the efficacy of heme arginate, singly or in combination with tin     mesoporphyrin, in lowering porphyrin precursors in patients with asymptomatic acute     intermittent porphyria.      II. Evaluate and compare the safety and tolerability of these treatment regimens in this     patient population.   "
164894|NCT00004397|"     OBJECTIVES: I. Evaluate the effectiveness of tin mesoporphyrin in reducing the number of heme     infusions needed to prevent acute attacks of porphyria.      II. Evaluate the safety and tolerability of tin mesoporphyrin in these patients.   "
164895|NCT00004398|"     OBJECTIVES: I. Evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria     attacks who are also treated with a standard course of heme arginate.      II. Evaluate the safety and tolerability of tin mesoporphyrin when administered to these     patients.   "
164896|NCT00004399|"     OBJECTIVES:      I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of     eclamptic seizures in patients with severe preeclampsia.   "
164897|NCT00004400|"     OBJECTIVES: I. Determine whether physiologic testosterone replacement can increase fat-free     mass, therefore contributing to weight maintenance, improved muscle function, and quality of     life in HIV-infected women.      II. Examine the mechanism of testosterone-induced increase in fat-free mass.   "
164898|NCT00004401|"     OBJECTIVES: I. Determine the safety of human botulism immune globulin (BIG) in patients with     infant botulism by monitoring side effects (e.g., rash, fever, hypotension, and anaphylaxis).      II. Assess the efficacy of BIG in these patients by monitoring disease severity, incidence of     complications (respiratory arrest, aspiration, pneumonia, etc.), and length of hospital stay.   "
164899|NCT00004402|"     OBJECTIVES: I. Compare the rate of treatment failure in osteopetrosis patients receiving     interferon gamma in combination with calcitriol to the rate of treatment failure in patients     receiving calcitriol alone.      II. Compare the number of adverse events or clinical manifestations of disease progression     occurring in these patients.      III. Assess the effects of interferon gamma on hematopoiesis, cranial nerve function, and     rate of infection in these patients.   "
164900|NCT00004403|"     OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the     severity and duration of epilepsy due to neurocysticercosis.      II. Determine the effect of a short course of albendazole on Taenia solium cysts present in     the brain.      III. Determine the natural regression of cerebral T. solium cysts in patients given placebo     and their response to treatment at the end of the study.   "
164901|NCT00004404|"     OBJECTIVES:      Determine the effectiveness of the combined use of clotrimazole and hydroxyurea on a specific     panel of red cell characteristics in patients with sickle cell syndromes.   "
164902|NCT00004406|"     OBJECTIVES:      I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men     with idiopathic osteoporosis.   "
164903|NCT00004407|"     OBJECTIVES: I. Determine the effect of intravenous immunoglobulin on recovery time of     patients with proximal diabetic neuropathy.      II. Determine whether rate of response is dose dependent in these patients.   "
164904|NCT00004408|"     OBJECTIVES: I. Assess the efficacy of poloxamer 188 in reducing the duration of painful     vaso-occlusive crisis in patients with sickle cell disease.      II. Assess the effect of poloxamer 188 on duration and intensity of pain, total analgesic     use, and length of hospitalization of these patients.   "
164905|NCT00004409|"     OBJECTIVES:      Evaluate the safety and efficacy of collagenase in improving flexion deformity, range of     motion, and grip strength in patients with residual Dupuytren's disease.   "
164906|NCT00004410|"     OBJECTIVES: I. Determine whether infants treated with tauroursodeoxycholic acid (TUDCA) have     a lower peak direct bilirubin, ALT, AST, glutamyltranspeptidase levels and a reduced duration     of cholestasis compared to the nontreatment arm.      II. Determine the significance of lower birth weight and longer duration of total parenteral     nutrition (TPN) on increasing risk of TPN associated cholestasis and increasing benefit from     TUDCA therapy.      III. Determine whether TUDCA therapy leads to significant reduction in the appearance of     biliary tract sludge and/or stone formation in these infants.      IV. Determine whether TUDCA therapy leads to reduced urinary excretion of potentially     hepatotoxic bile acids as compared to the untreated arm matched for birth weight and duration     of TPN.   "
164907|NCT00004412|"     OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate     in terms of healing rate in patients with refractory sickle cell ulcers.      II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion     or inhibition of wound healing in these patients.      III. Determine whether the regimen used in this study is appropriate for testing in pivotal     trials.   "
164908|NCT00004414|"     OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely     premature newborns on long term parenteral nutrition and given either sincalide or placebo.      II. Compare morbidity and mortality rates in this patient population. III. Evaluate     ultrasonographic images of the hepatobiliary tree during and 1 to 2 years after the     administration of sincalide or placebo to assess the development of biliary sludge and     biliary stone formation.   "
165106|NCT00005795|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have acute myeloid leukemia.   "
164909|NCT00004415|"     OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can     maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia     who are not candidates for phrenic nerve pacing alone.      II. Evaluate the efficacy of the Medlink device to produce synchronous intercostal and     diagram activation in these patients.   "
164910|NCT00004416|"     OBJECTIVES: I. Compare the efficacy of two doses of botulinum toxin in the treatment of     achalasia.      II. Compare the safety of these two doses in these patients.   "
164911|NCT00004418|"     OBJECTIVES: I. Evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl     trioleate (Lorenzo's Oil) therapy in boys with X-linked adrenoleukodystrophy.      II. Compare the frequency and severity of neurological disability of study patients with     untreated historical controls.   "
164912|NCT00004419|"     OBJECTIVES: I. Determine the efficacy and toxic effects of recombinant human insulin-like     growth factor I (rhIGF-I) on carbohydrate tolerance, insulin action, insulin secretion,     hyperandrogenism, and hyperlipidemia in patients with severe insulin resistance who have     failed other therapies.      II. Determine the dose and time response of rhIGF-I on carbohydrate homeostasis and secondary     abnormalities in this patient population.      III. Determine the effect of rhIGF-I on insulin clearance, the regulation of insulin-like     growth factor binding protein 1, the regulation of sex hormone binding globulin, and     hypothalamic pituitary gonadal axis in this patient population.   "
164913|NCT00004420|"     OBJECTIVES:      I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood     arthritis.   "
164914|NCT00004421|"     RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are     persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided     by a small, battery operated implant placed under the skin of the chest that delivers low     voltage electrical pulses through a wire under the skin that is connected to a specific area     of the brain. Deep brain stimulation may help lessen the symptoms of dystonia.      PURPOSE: Phase II/III trial to study the effectiveness of deep brain stimulation in treating     patients who have dystonia.   "
164915|NCT00004422|"     OBJECTIVES:      Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the     treatment of severe pertussis in children.   "
164916|NCT00004423|"     OBJECTIVES:      I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's     disease of the small bowel.   "
164917|NCT00004424|"     OBJECTIVES:      I. Assess the degree of amnesia afforded by study sedatives relative to the patient's     intensive care unit experiences.      II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional     sedative regimen consisting of continuous infusion fentanyl and midazolam.      III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to     combination drug therapy in acutely ill, mechanically ventilated pediatric patients.   "
164918|NCT00004426|"     RATIONALE: The body's response to one injection of leuprolide may provide more information     than the standard test for gonadotropin deficiency in determining whether the cause of     gonadotropin deficiency is related to the hypothalamus or the pituitary gland.      PURPOSE: Randomized double-blinded clinical trial to study the effectiveness of leuprolide in     determining the cause of gonadotropin deficiency.   "
164919|NCT00004428|"     OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients     with mild cystic fibrosis.      II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.   "
164920|NCT00004429|"     OBJECTIVES:      I. Assess the clinical safety and long term effects of recombinant human growth hormone on a     defined range of nutritional indices in malnourished chronic hemodialysis and continuous     ambulatory peritoneal dialysis patients.   "
164921|NCT00004430|"     OBJECTIVES:      I. Demonstrate the safety and efficacy of dihematoporphyrin derivative (DHP) in laser     photodynamic therapy (PDT) in patients with corneal neovascularization.      II. Document the histopathologic mechanism of action in selected patients undergoing     penetrating keratoplasty following PDT therapy for corneal neovascularization.      III. Facilitate FDA product approval of DHP as a photosensitizing agent for laser treatment     in these patients.      IV. Explore the use of this photosensitizer for ocular and cutaneous basal cell and squamous     cell carcinoma.   "
164922|NCT00004431|"     OBJECTIVES: I. Evaluate the efficacy of L-baclofen in patients with refractory trigeminal     neuralgia.      II. Evaluate the safety and tolerance of L-baclofen in these patients.   "
164923|NCT00004433|"     OBJECTIVES:      I. Evaluate the presumed mechanism of action of low dose pergolide to act acutely through the     dopaminergic autoreceptor or postsynaptically at D2 sites in children 7 to 17 with tourette     syndrome (GTS).      II. Compare tolerability and safety of pergolide in these patients to standard neuroleptic     therapy via naturalist assessment after 3-6 months of treatment using matched historical     controls on neuroleptics.      III. Determine efficacy of pergolide for tic control in these patients.   "
164924|NCT00004436|"     OBJECTIVES: I. Evaluate the clinical efficacy of leuprolide, a gonadotropin-releasing hormone     agonist (GnRHa), in treating infants with vision-endangering or large, disfiguring     hemangiomas.      II. Assess the impact of GnRHa on growth and development during infancy. III. Assess the     safety of GnHRa in these patients.   "
164925|NCT00004437|"     OBJECTIVES: I. Define the tonotopocity of multichannel brain stem stimulation and use this     information to better program the auditory brain stem implant for an individual.      II. Optimize device fitting by combining monopolar and bipolar stimulation, and individual     psychoacoustic channels for each patient, to increase the number of usable information     channels for each patient and reduce or eliminate undesirable side effects.      III. Evaluate performance and learning effects using optimized fitting procedures.   "
164926|NCT00004438|"     RATIONALE: Hypogonadotropism is an abnormal condition caused by decreased production of     gonadotropins, a group of hormones that stimulate the parts of the reproductive system that     produce and release eggs from the ovaries or sperm from the testicles. Leuprolide may     stimulate the production of gonadotropins and be effective in increasing testosterone in men     and inducing ovulation in women.      PURPOSE: Clinical trial to study the effectiveness of leuprolide in treating adults who have     hypogonadotropism.   "
176336|NCT00151099|"     The purpose of the study is to determine whether the oral administration of a high caloric     drink with protein decreases the postoperative nausea and vomiting in patients with     dysgnathia.   "
164927|NCT00004440|"     OBJECTIVES:      I. Determine the effect of different doses of ibuprofen on neutrophil (polymorphonuclear     leukocyte; PMN) delivery to a mucosal surface (the oral mucosa) in patients with cystic     fibrosis and healthy controls.      II. Determine the duration of effect (and possible rebound effect) of ibuprofen on PMN     delivery to a mucosal surface in these patients.   "
164928|NCT00004441|"     OBJECTIVES: I. Determine the optimum dose of tauroursodeoxycholic acid (TUDCA) required to     achieve maximal bioavailability for patients with cystic fibrosis-associated liver disease.      II. Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects     on biliary bile acid composition and metabolism, serum biochemistries, fat absorption, and     fat-soluble vitamin status in these patients.   "
164929|NCT00004442|"     OBJECTIVES: I. Determine the effectiveness of oral bile acid therapy with cholic acid,     chenodeoxycholic acid, and ursodeoxycholic acid in patients with peroxisomal disorders     involving impaired primary bile acid synthesis.      II. Determine whether suppression of synthesis of atypical bile acids and enrichment of bile     acid pool with this regimen is effective in treating this patient population and improving     quality of life.   "
164930|NCT00004443|"     OBJECTIVES: I. Assess the safety and efficacy of NTBC in children with tyrosinemia I.      II. Evaluate the effects of NTBC on survival, rate of neurologic crises, improvement in renal     tubular damage, reduction in the need for liver transplantation, and reduction in the     development of hepatocarcinoma in these patients.   "
164931|NCT00004444|"     OBJECTIVES: I. Compare the pharmacokinetics and early bactericidal activity of paromomycin     (aminosidine) vs streptomycin for the treatment of uncomplicated pulmonary tuberculosis.      II. Compare the tolerability of these two drugs in these patients. III. Establish the     relationships between achieved serum concentration, minimal inhibitory concentration, and     early bactericidal activity of paromomycin and streptomycin.   "
164932|NCT00004445|"     OBJECTIVES:      I. Establish the procedures for implementing and assessing the clinical utility of functional     neuromuscular stimulation using an implanted eight-channel standing and transfer system in     patients with incomplete tetraplegia or paraplegia.      II. Develop and apply quantitative functional evaluations of system performance in these     patients.      III. Perform long term follow up and monitor system use outside of the laboratory.   "
164933|NCT00004446|"     The purpose of this study is to:      1) Determine the effects of fluoxetine in the treatment of depersonalization disorder, 2)     Assess the durability of treatment response in these patients, 3) Assess the improvement in     psychiatric disability in these patients, and 4) Assess the effects of comorbid Axis I     disorders (depression, social phobia, panic/anxiety, obsessive-compulsive disorder) and Axis     II personality disorders on treatment outcome in these patients.   "
164934|NCT00004448|"     OBJECTIVES:      Evaluate the efficacy of alternate day prednisone versus daily fish oil supplements in     slowing or preventing the decline in renal function in children, adolescents, and young     adults with moderate to severe immunoglobulin A nephropathy.   "
164935|NCT00004449|"     OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in     the home or neighborhood compared with at home, individualized, parent training in preschool     aged children with autism.      II. Identify intake measures that predict differences in outcome between subjects in the     experimental group.   "
164936|NCT00004450|"     OBJECTIVES: I. Evaluate the efficacy of interferon beta and thalidomide in male patients with     adrenoleukodystrophy who show evidence of brain inflammatory response and are receiving     concurrent glyceryl trierucate and glyceryl trioleate (Lorenzo's oil).      II. Evaluate the progress of the disease and possible side effects of the medication in these     patients.   "
164937|NCT00004451|"     This study will determine whether glucose facilitates memory in healthy elderly people and     those with Parkinson's disease.   "
164938|NCT00004454|"     OBJECTIVES: I. Evaluate the safety and feasibility of treating mucopolysaccharidosis II (mild     Hunter syndrome) by lymphocyte gene therapy.      II. Determine the levels of iduronate-2-sulfatase enzyme in these patients attained by     infusing increasing doses of lymphocytes transduced with a retroviral vector designed for     insertion and expression of this iduronate-2-sulfatase gene (L2SN).      III. Determine the duration of survival of these transduced cells in these patients.      IV. Determine whether monthly infusion of L2SN-transduced lymphocytes accomplishes metabolic     correction (as measured by glycosaminoglycan excretion), decrease in liver or spleen volume,     any therapeutic effect upon cardiac and pulmonary dysfunction, or any other effects from     treatment.   "
164939|NCT00004457|"     OBJECTIVES:      I. Determine specific clinical features, molecular abnormalities, and laboratory-based     biological markers of free radical stress that are associated with amyotrophic lateral     sclerosis and influence disease severity.   "
164940|NCT00004458|"     OBJECTIVES:      I. Compare the developmental course (language acquisition, diagnostic stability, predictors     of outcome, and restricted interests and behaviors) of childhood disintegrative disorder     versus autism and non-autistic developmental delays.      II. Collect data on molecular genetics of proband and family members.   "
164941|NCT00004464|"     OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose     cyclophosphamide in patients with severe aplastic anemia.      II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide     shortens the time to recovery in these patients.      III. Determine whether this regimen is efficacious in treating paroxysmal nocturnal     hemoglobinuria.   "
164942|NCT00004465|"     OBJECTIVES: I. Determine the effect of SYNSORB Pk therapy on mortality and frequency of     severe extrarenal complications observed in children with acute stage E. coli-associated     hemolytic uremic syndrome.      II. Determine the effect of SYNSORB Pk therapy on the need for the duration of dialysis in     these patients.      III. Determine the effect of SYNSORB Pk therapy on the recovery of renal function and     resolution of urinary abnormalities in these patients.   "
164943|NCT00004466|"     OBJECTIVES:      I. Determine the effect of atorvastatin on the plasma levels of lipids, Lp(a), and     apoproteins for treating hyperlipidemia in children with nephrotic syndrome in whom     proteinuria and hyperlipidemia persist after other appropriate measures to treat their     primary disease have been exhausted.      II. Determine the safety and tolerability of atorvastatin in these patients.      III. Provide preliminary data for a future investigation into the potential effect that     lowering cholesterol levels may have on the rate of progression of renal insufficiency in     such patients.   "
164945|NCT00004468|"     OBJECTIVES: I. Evaluate the long term safety and efficacy of orally administered calcitriol     in patients with at least 5% of their body covered with psoriasis.      II. Evaluate the long term safety and efficacy of topically administered calcitriol in     patients with at least 5% of their body covered with psoriasis.      III. Compare the topical calcitriol treatment to the oral calcitriol treatment in these     patients.   "
164946|NCT00004471|"     OBJECTIVES:      Determine whether copies of the cystic fibrosis gene (pGT-1) can be delivered to the cells     lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated     gene transfer.   "
164947|NCT00004474|"     OBJECTIVES:      I. Compare outcome, including graft failure, graft versus host disease, and survival of     HLA-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with     or without antithymocyte globulin as a conditioning regimen.   "
164948|NCT00004475|"     OBJECTIVES:      I. Establish linkage in families with hereditary pancreatitis between the phenotype and a     chromosomal locus (loci) that contains the responsible gene.   "
164949|NCT00004478|"     Please note that the continuation study can be found at     http://clinicaltrials.gov/show/NCT00633880.      RATIONALE: Neurogenic hypotension is a fall in blood pressure that occurs when one moves from     a lying down to a standing position or after eating a meal. It causes one to feel dizzy,     light headed, and weak. Neurogenic hypotension is caused by a problem in the part of the     nervous system that controls such functions as heart rate and blood pressure. Droxidopa, a     drug that may increase blood pressure, may be an effective treatment for neurogenic     hypotension.      PURPOSE: Clinical trial to study the effectiveness of droxidopa in treating patients who have     neurogenic hypotension.   "
164950|NCT00004479|"     OBJECTIVES:      Determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing     neurally mediated syncope.   "
164951|NCT00004480|"     OBJECTIVES:      I. Determine the optimal dose of botulinum toxin necessary to decrease sweating in patients     with primary hyperhidrosis.   "
164952|NCT00004481|"     OBJECTIVES:      I. Identify the genetic defect and fine map the gene that causes sitosterolemia.   "
164953|NCT00004482|"     OBJECTIVES:      I. Assess the effect of immunosuppression with muromonab-CD3, cyclosporine,     methylprednisolone, and prednisone versus standard care in terms of death, heart     transplantation, or left ventricular assistive device placement in patients with giant cell     myocarditis.      II. Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in     these arms.      III. Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of     treatment in these arms.   "
164954|NCT00004483|"     OBJECTIVES:      I. Define the growth rates and clinical course of NF2-related tumors in patients with     neurofibromatosis type 2. Associate growth rate with physical function.   "
164955|NCT00004485|"     RATIONALE: Sickle cell disease is an inherited disorder in which abnormal, crescent-shaped     red blood cells interfere with the ability of the blood to carry oxygen through the body and     can cause severe pain, stroke, and organ damage. Bone marrow transplantation, is a procedure     in which the soft, sponge-like tissue in the center of bones producing white blood cells, red     blood cells, and platelets is replaced by bone marrow from a another person. Bone marrow     transplantation may be an effective treatment in relieving the symptoms of sickle cell     disease.      PURPOSE: Phase I/II trial to study the effectiveness of bone marrow transplantation in     treating children who have sickle cell disease.   "
164956|NCT00004486|"     OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global     severity and compulsive dimensions of children and adolescents with autism.      II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this     patient population.      III. Compare the baseline compulsive severity and treatment outcome in these patients.   "
164957|NCT00004487|"     OBJECTIVES: I. Determine the safety and efficacy of chondrocyte alginate gel suspension in     pediatric patients with vesicoureteral reflux.      II. Determine the long term efficacy of this treatment regimen in this patient population.      III. Evaluate the short and long term avoidance of surgery or antibiotic therapy after this     treatment regimen in this patient population.      IV. Estimate the risk:benefit ratio of this treatment regimen in these patients.   "
164958|NCT00004488|"     OBJECTIVES:      I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone     density and focal bone lesions) in patients with Gaucher's disease.   "
164959|NCT00004489|"     OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone     metabolism in patients with cystic fibrosis.      II. Assess the safety and efficacy of this treatment regimen in improving osteoporosis in     this patient population.   "
164960|NCT00004490|"     OBJECTIVES:      I. Compare the safety of sodium dichloroacetate (DCA) vs placebo in children with congenital     lactic acidosis.      II. Determine the quality of life of these patients.      III. Determine the pharmacokinetics and metabolic fate of DCA over the course of drug     administration in these patients.   "
164961|NCT00004492|"     OBJECTIVES:      I. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the     severity of anemia and the rate of hemolysis in patients with sickle cell anemia.   "
164962|NCT00004493|"     OBJECTIVES: I. Determine the pharmacokinetics of sodium dichloroacetate (DCA) in patients     with congenital lactic acidemia.      II. Determine the efficacy of DCA in decreasing the frequency and/or severity of acute     episodes of acidotic illness, improving linear growth, improving neurological or     developmental function, or slowing neurological or developmental deterioration in these     patients.   "
164963|NCT00004494|"     OBJECTIVES:      I. Determine the maximum tolerated dose of vasoactive intestinal peptide in patients with     acute respiratory distress syndrome.      II. Evaluate the safety and pharmacodynamic activity of this peptide in these patients.   "
164964|NCT00004495|"     OBJECTIVES: I. Compare the efficacy of two doses of folic acid in normalizing plasma total     homocysteine concentration in patients with end stage renal disease receiving regular     hemodialysis therapy resulting in hyperhomocysteinemia.      II. Determine the requirement of co-supplementation with extra pyridoxine (vitamin B6) and     cyanocobalamin (vitamin B12) daily in these patients.      III. Assess the safety and tolerability of this therapy in these patients.   "
176399|NCT00151866|"     The purpose of this study is to evaluate the clinical efficacy of transfusions with platelets     stored in platelet additive solution II compared to plasma storage.   "
164965|NCT00004496|"     OBJECTIVES: I. Determine the maximum tolerated dose and safety of alpha-melanocyte     stimulating hormone (alpha-MSH) in patients with acute renal failure.      II. Determine the safety and pharmacokinetics of alpha-MSH in patients at high risk of acute     renal failure after renal transplantation.      III. Determine the safety and pharmacokinetics of alpha-MSH in patients with established     ischemic acute renal failure.      IV. Determine the effect of alpha-MSH on interleukin-10 pharmacokinetics.   "
164966|NCT00004497|"     OBJECTIVES:      I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary     pulmonary hypertension.   "
164967|NCT00004498|"     OBJECTIVES:      I. Determine the safety, feasibility, and potential efficacy of intravascular adenoviral     vector mediated gene transfer in the liver in adults with partial ornithine transcarbamylase     deficiency.   "
164968|NCT00004500|"     OBJECTIVES:      Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL)     in the treatment of meconium aspiration syndrome (MAS) in newborn infants.   "
164969|NCT00004533|"     OBJECTIVES:      I. Determine the maximum tolerated dose of recombinant adeno-associated virus-CFTR vector in     patients with cystic fibrosis.      II. Assess the safety of this gene therapy in these patients.      III. Assess the in vivo gene transfer of this vector in these patients.      IV. Assess the CFTR gene expression and physiologic activity following gene transfer in these     patients.      V. Assess the clinical impact of CFTR gene expression following gene transfer in these     patients.      VI. Monitor patient immune response directed against CFTR or vector components following     vector administration.   "
164970|NCT00004547|"     This study will test the effectiveness of an experimental treatment for peritoneal cancer     involving surgical removal of the tumor, perfusion of the abdomen during surgery with a     heated solution of the drug cisplatin, and post-surgery combination chemotherapy in the     abdomen with fluorouracil (5-FU) and paclitaxel.      Patients with certain peritoneal cancer whose tumors are confined to the abdomen may be     eligible for this study. Candidates are screened with a medical history and physical     examination, including blood tests, electrocardiogram and possibly bone scan, brain magnetic     resonance imaging (MRI), and chest, abdomen and pelvic CT scans.      Participants undergo surgery to remove as much tumor as possible. Part of the intestines,     pancreas, stomach or the entire spleen may also be removed if they are affected. During     surgery, after the tumor has been removed, two catheters (thin plastic tubes) are placed in     the abdomen. A chemotherapy solution containing the anti-cancer drug cisplatin heated to a     temperature of about 108.6 degrees (10 degrees above normal body temperature) is then     delivered into the abdomen through one catheter and drained through another. During     treatment, a drug called sodium thiosulfate is given through a vein to reduce the risk of     side effects of cisplatin, particularly kidney damage. After 90 minutes of bathing the     abdomen with this solution, the drug is rinsed from the abdomen and the catheters removed.     Another small catheter is then placed and left inside the abdomen with one end coming out     through the skin. Seven to 12 days after the operation, the anti-cancer drugs 5-FU and     paclitaxel are given through this catheter.      After complete recovery from the surgery, the catheter is removed and the patient is     discharged from the hospital. Clinic visits are scheduled for periodic follow-up examination,     imaging, and tests 3 and 6 months after surgery and every 6 months for up to 5 years as long     as the disease does not worsen. Patients whose disease progresses are taken off the study and     referred back to their local physician or referred for alternative care or other research     studies.      Patients are also asked to assess how this therapy affects their general health and well     being. This will require filling out two quality-of-life (QOL) questionnaires before surgery     and again at each follow-up visit after surgery. Each questionnaire takes about 15 minutes to     complete.   "
164971|NCT00004549|"     This study will examine the use of magnetic resonance imaging (MRI) in detecting blood vessel     inflammation. The results of this study may later be applied to diagnosing inflammation of     arteries in patients with atherosclerosis, predicting disease progression in these patients,     and guiding therapy.      Patients with peripheral artery disease (for example, blockage of a leg artery) undergoing     balloon angioplasty at Suburban Hospital in Bethesda, Maryland, may be eligible to     participate in this study. Because this procedure, which opens blocked arteries, can cause     inflammation in the vessel wall, it affords an opportunity for studying MRI detection of such     inflammation.      Study candidates will be screened with a medical history and physical examination.     Participants will have a MRI scan and blood drawn at Suburban Hospital before the angioplasty     and again either 1 to 3 days or 2 weeks after the procedure. Before the MRI scan is begun, a     catheter (a thin plastic tube) is inserted in an arm vein and 90 milliliters (about 3 ounces)     of blood is drawn. The patient then lies on a table that slides into the MRI scanner-a large     donut-shaped machine with a magnetic field. A flexible, padded sensor called an MRI coil is     placed over the area to be imaged; this device is used to improve the quality of the     pictures. During the scan a contrast material called gadolinium is injected through the     catheter. Gadolinium brightens the image of the blood vessels. The procedure lasts up to 2     hours.   "
164972|NCT00004550|"     The purpose of this study is to better understand the long-term progress of people with     obsessive-compulsive disorder (OCD) and related conditions such as anorexia nervosa, Tourette     syndrome, and trichotillomania.      This study involves the screening and follow-up of individuals with OCD and OCD-related     disorders. Participants will be screened with a medical and psychiatric evaluation,     questionnaires, and neurological testing. Participants will then have study visits every 4 to     12 weeks to undergo symptom and daily functioning evaluations, personality tests, blood and     urine tests, memory tests, brain scans, and other clinical exams. Participants will be     assessed with interviews and paper-and-pencil or computer-assisted tests. Participants may     have the opportunity to participate in drug studies and to join a monthly OCD support group.     At the end of the study, participants will be referred to community or private treatment     centers.   "
164973|NCT00004551|"     This study is to evaluate the effectiveness of a mood management intervention on abstinent     alcoholic smokers with a history of major depression. The second aim is to determine the     effect of smoking treatments on alcohol abstinence and to identify factors associated with     smoking and alcohol outcomes (e.g., more days of abstinence). A randomized, two-group design     will be used to evaluate the added benefit of mood management compared to a state-of-the-art     smoking cessation treatment. Treatment will consist of 8 weekly group sessions and 1, 3, 6,     and 12-month follow-up.   "
164974|NCT00004552|"     This study will examine whether pretreatment with two doses of acamprosate for seven days     prior to abstinence lessens the intensity of acute withdrawal from alcohol compared with a     placebo. Subjects will be randomly assigned to receive either one of two doses of acamprosate     or placebo for seven days. This will be followed by a four- day inpatient period when     withdrawal will be monitored. Additional drinking information will be obtained at a three     month followup interview.   "
165067|NCT00005470|"     To continue examinations of 670 girls enrolled in the National Growth and Health Study (NGHS)     for four more years, adding measurements of total peripheral resistance, cardiac output, DEXA     scans for fat-free mass and fat mass, left ventricular mass and geometry, circulating blood     volume, whole blood viscosity, and left ventricular contractility.   "
164975|NCT00004553|"     This study will investigate problems with muscle weakness and control using     electromyography-a test of nerve-muscle cell communication. Advanced techniques called single     fiber electromyography and macro-electromyography, which evaluate individual muscle fibers,     will be used. Besides aiding in diagnosis, these tests provide information about disease     progression that may be useful in guiding therapy.      Adult patients with suspected neurological disorders of muscle control and weakness may be     eligible for this study. Normal volunteers may also participate. For the electromyography     procedure, a special needle is inserted into a muscle. The patient will slightly tense the     muscle and maintain the tension while electrical signals from the muscle fibers are being     recorded. The electrical signals are played through a loudspeaker, providing feedback to help     the patient tense the muscle the appropriate amount. The test, which is usually done for only     one muscle, takes 1 to 2 hours. If needed, short breaks can be taken.      If the patient cannot maintain tension in the muscle for the entire test period, a nerve will     be stimulated to activate the muscle. A thin needle is inserted near the nerve, and a series     of small electrical shocks are given to activate a nerve fiber. The electromyography needle     is inserted into the muscle to measure the response, as described above.      A neurologist receiving specialized training in clinical neurophysiology will do the     electromyography procedure under the direct supervision of an experienced neurologist.   "
164976|NCT00004554|"     This study will examine depressed alcoholic outpatients to assess whether combining     naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking     and depression over either medication alone or placebo. A secondary aim is to determine     whether certain patient features will predict response to sertraline, naltrexone or the     combination of the two drugs. Subjects will be randomized into treatment groups for 14 weeks.     The followup phase includes two visits at 6 and 9 months after treatment.   "
164977|NCT00004556|"     The purpose of this study is to determine the effects of the drug dextroamphetamine on the     brain function and mood of healthy volunteers.      Monoaminergic drugs are substances that affect the nervous system; these drugs can raise,     hamper, or have no effect on brain function when given to healthy individuals. Different     responses to a drug may be the result of genetic variations. This study will examine the     effects of the monoaminergic drug dextroamphetamine on thought and sensorimotor processes     while participants perform a variety of tasks.      Participants in this study will undergo a medical history, physical examination, blood tests,     and an electrocardiogram (EKG). Women of reproductive potential will undergo a pregnancy     test. Participants will be given either dextroamphetamine or placebo (an inactive solution)     on two occasions separated by at least 3 to 7 days. Participants will then perform     neuropsychological tests that will measure attention, problem solving, memory, and ability to     complete simple motor tasks.   "
164978|NCT00004557|"     Patients with Alzheimer's disease (AD) perform poorly on tasks dependent on access to, and     utilization of, previously acquired knowledge and skills. It has been commonly assumed that     impaired knowledge in AD, as well as in other patients with cortical lesions, is due to an     actual loss or disorganization of a specific knowledge base or system. This hypothesis has,     however, recently been called into question by data from tasks that purport to tap knowledge     on a more automatic and implicit level. For example, although AD patients are impaired on     object naming and verbal fluency tasks, they show a normal pattern of semantic facilitation     on reaction time based priming tasks. In fact, the level of facilitation or activation on     these tasks has often been reported to be greater in AD patients than in normal individuals.     These and similar data have been used to support arguments that performance decrements in AD     patients are due to deficits in attentional and/or retrieval processes rather than a     degradation of knowledge stores. The central focus of this project will be to test a model of     the semantic representations of object that predicts increased facilitation or hyperpriming     in AD patients as a result of degraded representations. The relationship between performance     on on-line priming tasks, visual attention and spatial processes, and explicit and implicit     measures of memory also will be examined. In addition to normal controls, patients with     cognitive and memory impairments, but without semantically-based naming difficulties (elderly     depressed, Huntington's disease, Korsakoff's disease) will serve as controls for overall     slowness of response and degree of explicit memory deficit.   "
164979|NCT00004558|"     To determine the antiarrhythmic effects of dietary N-3 fatty acids in patients with implanted     defibrillators.   "
164980|NCT00004559|"     To determine if the dietary N-3 class of polyunsaturated fatty acids (PUFAs) provided in the     diet largely from marine fish oils would prevent fatal ventricular tachycardia (VT) or     ventricular fibrillation (VF).   "
164981|NCT00004560|"     To measure survival to hospital discharge of patients with out-of-hospital cardiac arrest in     community units (e.g., apartment or office buildings, gated communities, sports venues,     senior centers, shopping malls) served by trained non-medical responders using automated     external defibrillators (AEDs), an approach called Public Access Defibrillation, compared to     units receiving the traditional optimum community standard of care (i.e., rescuers trained to     recognize a cardiac emergency, call 911, and initiate CPR).   "
164982|NCT00004561|"     To determine whether exercise training could significantly replace medication as a treatment     for mild essential hypertension.   "
164983|NCT00004562|"     The purpose of this study is to determine whether opening an occluded infarcted artery 3-28     days after an acute myocardial infarction in high-risk asymptomatic patients reduces the     composite endpoint of mortality, recurrent myocardial infarction, and hospitalization for     class IV congestive heart failure over an average 2.9-year follow-up with extended follow up     for an average of six years. Long term follow-up of patients were completed in March 2010.     Final collection of all regulatory documentation was completed June 2011.   "
164984|NCT00004563|"     To evaluate the efficacy and safety of cyclophosphamide versus placebo for the prevention and     progression of symptomatic pulmonary disease in patients with systemic sclerosis.   "
165004|NCT00004583|"     The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it     fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more     virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with     another PI, nelfinavir (NFV).      Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at     fighting HIV infection.   "
164985|NCT00004564|"     The objective of this study is to determine if the action of the drug called clopidogrel,     that you will start taking, will be decreased by another drug called atorvastatin, that you     will also start taking. Clopidogrel is an oral antiplatelet agent that has been shown to     prevent strokes and heart attacks. Atorvastatin is a cholesterol lowering agent.      Twenty adults 18-75 years of age requiring cholesterol-lowering agent and antiplatelet agent     therapy will be recruited for this study during their cardiology clinic visitation. In one     group, antiplatelet agent (clopidogrel) regimen will be administered first, then followed by     cholesterol-lowering medication (atorvastatin). In the second group, atorvastatin will be     administered first, followed by clopidogrel.      A new test called the erythromycin breath test will be administered to you three times during     the study to measure how your liver will metabolize these drugs. Blood samples will also be     obtained to assess platelet function. The criteria for exclusion are patient refusal or     inability to give written consent, patients with allergic reaction to erythromycin, patients     with known bleeding problems, liver disease, significant lung disease kidney disease and     pregnancy. Patients with psychiatric impairment and documented history of substance abuse     will also be excluded from the study.   "
164986|NCT00004565|"     This study will explore whether different forms, or variants, of genes are related to a     person s risk of developing breast cancer. The genes that are looked at have no clinical     significance today, and thus will not impact your personal healthcare at this time. However,     these results may help researchers better understand why some people develop breast cancer     and others do not. The study will try to determine:      if people with breast cancer have different gene variants from people without the disease;      if these genetic differences influence a person s susceptibility to breast cancer when they     are exposed to certain environmental substances, such as nicotine and estrogen; and      if breast cancer that occurs in families is related to a grouping of these variants.      The study will also look for certain proteins, cells, or other substances in fluid aspirated     (by the use of gentle suction; no needles) from the nipple that might represent a pattern, or     fingerprint, indicating increased risk for breast cancer.      Study participants will complete questionnaires on cancer risk factors, diet, and family     history. A small blood sample (3 tablespoons) will be drawn for study of genetic differences     between people with breast cancer and people who are cancer-free. Nipple aspirations, a     noninvasive method to obtain fluid from a women s breast, will be attempted 4 to 6 times,     over a 4 6 week period. For this procedure, the subject places a warm moist towel over the     breasts for about 20 minutes. The breasts are then cleansed with a rubbing alcohol pad. The     subject compresses the breast with both hands and a small plastic cup is inverted over the     breast. Suction is applied to a small syringe (no needles) attached to the cup for about 15     seconds. The procedure may be repeated up to 5 times on each breast. Any drops of fluid     obtained from the nipple will be collected in a glass tube.   "
164987|NCT00004566|"     This study will establish a database of fetal movements associated with feeding. It will use     information obtained from standard fetal ultrasound procedures to identify and measure the     growth of the baby's face, lips, tongue, jaw, throat and airway. Fetal movements involved in     breathing, sucking and swallowing will be recorded on videotape. This study may provide     information that will:      increase knowledge about how swallowing develops in the fetus;      help explain why some babies have difficulty sucking and swallowing at birth; help predict     what babies are at increased risk for feeding problems; and help design better ways to manage     feeding difficulties in babies.      Pregnant women scheduled for ultrasound examination at the National Naval Medical Center in     Bethesda, Maryland, or Georgetown University Hospital in Washington, D.C., are eligible for     this study. Mothers will fill out a questionnaire providing general medical and health     information. For the ultrasound procedure, a transducer (a small, wand-like device) is moved     across the belly to produce images of the fetus. When the baby is awake and swallowing,     images of the mouth, throat and air passages will be recorded on videotape. The movements     associated with feeding-breathing, sucking, yawning and swallowing-will then be measured to     document how swallowing develops.      When the baby is born, researchers will review the medical chart for any findings relevant to     this study. One to 2 weeks after delivery, the mother will be interviewed by telephone about     the baby's feeding skills. Follow-up visits at 4 and 8 weeks after the birth will include     observation of the baby's sucking and swallowing and an ultrasound examination, in which the     transducer is held under the baby's chin during swallowing.      Babies who show signs of slow sucking or swallowing development will have a follow-up     examination at ages 4 and 8 months. Follow-up visits at 4 and 8 months after the birth will     include observation of the baby's sucking and swallowing and an ultrasound examination, in     which the transducer is held under the baby's chin during swallowing.   "
164988|NCT00004567|"     This study will compare the safety and effectiveness of two drugs-methotrexate and     mycophenolate mofetil (MPM)-in preventing disease recurrence in patients with Wegener's     granulomatosis and related inflammatory blood vessel disorders. The standard treatment for     these conditions is combination drug therapy with prednisone plus cyclophosphamide. However,     although most patients improve on this therapy and achieve disease remission, many experience     a relapse (return of the disease) some time after therapy is stopped. Also, these drugs can     produce serious side effects during treatment. This study will test a new treatment regimen     to try to maintain disease remission in these patients with minimal side effects.      Patients with Wegener's granulomatosis or other related blood vessel disorders between 10 and     80 years old will be considered for this study. All participants will start therapy with     daily doses of prednisone and cyclophosphamide. Prednisone will be reduced gradually and then     stopped after symptoms improve significantly. Cyclophosphamide will continue until the     disease is in remission. Patients in remission will then be randomly assigned to continue     treatment with either MPM or methotrexate. MPM is taken twice a day by mouth. Methotrexate is     taken once a week, usually by mouth, but in some cases, by injection into a muscle or under     the skin. Patients who do well and have no side effects will continue treatment for 2 years.     Then, the drug will gradually be reduced (usually at monthly intervals) and finally stopped.     No further treatment will be given unless a relapse occurs. At that time, the type of     treatment will depend on various medical factors, including the severity of the recurrence     and the patient's history of drug side effects.      Physical examinations and various tests, including blood and urine analyses, and X-rays, will     be done periodically to evaluate the response to treatment and monitor drug side effects. The     total duration of the study-from the screening evaluation through a 2-year follow up after     all medications have been stopped-is about 5 to 6 years.   "
164989|NCT00004568|"     This study is designed to learn more about the natural history of inherited neurological     disorders and the role of heredity in their development. It will examine the genetics,     symptoms, disease progression, treatment, and psychological and behavioral impact of diseases     in the following categories: hereditary peripheral neuropathies; hereditary myopathies;     muscular dystrophies; hereditary motor neuron disorders; mitochondrial myopathies; ataxias;     hereditary neurocognitive disorders; inherited neurological disorders without known     diagnosis; and others. Many of these diseases, which affect the brain, spinal cord, muscles,     and nerves, are rare and poorly understood.      Children and adults of all ages with various inherited neurological disorders may be eligible     for this study. Participants will undergo a detailed medical and family history, and a family     tree will be drawn. They will also have a physical and neurological examination that may     include blood test and urine tests, an EEG (brain wave recordings), psychological tests, and     speech and language and rehabilitation evaluations. A blood sample or skin biopsy may be     taken for genetic testing. Depending on the individual patient s symptoms, imaging tests such     as X-rays, CT or MRI scans and muscle and nerve testing may also be done.      Information from this study may provide a better understanding of the genetic underpinnings     of these disorders, contributing to improved diagnosis, treatment, and genetic counseling,     and perhaps leading to additional studies in these areas.   "
165005|NCT00004584|"     The purpose of this study is to look at the safety and effectiveness of an experimental     protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an     anti-HIV drug combination that includes BMS-232632 to a drug combination that includes     ritonavir.   "
165006|NCT00004585|"     The purpose of this study is to see if a certain combination of anti-HIV drugs is safe and     effective in HIV-infected patients. The drug combination includes a tablet containing     lamivudine and zidovudine (called Combivir) plus abacavir plus efavirenz.   "
164990|NCT00004569|"     The diagnosis and treatment of sleep disordered breathing have come to the forefront of     clinical medicine following recognition of the high prevalence and associated morbidity of     sleep apnea. The effects on quality of life as well as societal costs have been well     documented. The NYU Sleep Research Laboratory has spent the last several years working on the     problem of improving the diagnosis of mild sleep disordered breathing which manifests as the     upper airway resistance syndrome. Our approach has been to develop a non-invasive technique     to detect increased upper airway resistance directly from analysis of the airflow signal. A     characteristic intermittent change of the inspiratory flow contour, which is indicative of     the occurrence of flow limitation, correlates well with increased airway resistance.      Currently all respiratory events are identified manually and totaled. This is time consuming     and subject to variability. The objective of the present project is to improve upon the     manual approach by implementing an artificially intelligent system for the identification and     quantification of sleep disordered breathing based solely on non-invasive cardiopulmonary     signals collected during a routine sleep study. The utility of other reported indices of     sleep disordered breathing obtained during a sleep study will be evaluated.      Successful development of an automated system that can identify and classify upper airway     resistance events will simplify, standardize and improve the diagnosis of sleep disordered     breathing, and greatly facilitate research and clinical work in this area. Using a     physiological based determination of disease should allow better assessment of treatment     responses in mild disease.   "
164991|NCT00004570|"     Some children with certain language disorders may not properly process the sounds they hear,     resulting in language impairments. The purpose of this study is to determine if deficits in     auditory temporal processing the way the brain analyzes the timing and patterns of sounds are     an inherited trait.      Families with auditory temporal processing deficits are sought in order to identify the genes     responsible for auditory temporal processing deficits. Children and adults with a diagnosis     or history of language impairment in the family and their family members both affected and     non-affected are eligible for this two-part study. In Part 1, participants undergo a series     of language tests and listening tests to measure various characteristics of how they perceive     sound. In Part 2, they are interviewed about language disorders, learning disabilities, and     other medical problems of family members. This information is used to construct a pedigree     (family tree diagram) showing the pattern of inheritance of family traits. Study subjects     whose pedigree indicates that language disorders may be hereditary in their family will     provide either a small blood sample (1 to 2 tablespoons) or a tissue specimen obtained from a     cheek swab (rubbing the inside of the cheek with a small brush or cotton swabs). The sample     will be used to isolate DNA for genetic analysis.   "
164992|NCT00004571|"     The purpose of this study is to use brain imaging technology to compare differences in brain     structure, chemistry, and functioning in individuals with brain and mental disorders compared     to healthy volunteers.      Schizophrenia is a brain disorder that results from subtle changes and abnormalities in     neurons. These deficits likely occur in localized regions of the brain and may result in     widespread, devastating consequences. The neuronal abnormalities are inherited through a     complex combination of genetic and environmental factors. Brain imaging technologies can be     used to better characterize brain changes in individuals with schizophrenia. This study will     use magnetic resonance imaging (MRI) scans to identify predictable, quantifiable     abnormalities in neurophysiology, neurochemistry and neuroanatomy that characterize     schizophrenia and other neurological and neuropsychiatric disorders.   "
164993|NCT00004572|"     The two major types of diabetes are type 1 and type 2 diabetes. Although most patients with     type 2 diabetes are older than age 40, type 2 diabetes has been reported with increasing     frequency among patients under the age of 20. This form of diabetes has been called type 2     diabetes of youth, abbreviated type 2Y. Little is known about the etiology of type 2Y;     however, clinicians believe that it occurs most commonly in obese children of particular     ethnic groups. A positive family history appears to be one major risk factor for developing     type 2Y diabetes. The individual contribution of ethnicity, obesity, and genetics to type 2Y     have yet to be elucidated. There is no consensus regarding treatment with type 2Y diabetes.     Observation of our Hispanic patients in the Houston area reveals a large number with type 2Y.     The major purpose of this study is to examine the genetic and environmental risk factors such     as family history, ethnicity, and obesity in Hispanic children with type 2Y diabetes.     SPECIFIC AIMS: 1) To examine the genetic and environmental risk factors and clinical signs     associated with type 1 diabetes and type 2 diabetes of youth. 2) To compare the efficacy of     the treatment modalities, insulin and oral agents, in type 2Y patients. METHODS: We will     undertake a retrospective case study, to include a review of hypothesized risk factors in all     the medical records of pediatric diabetes patients seen at University of Texas. We anticipate     that approximately 200 patients with type 1 diabetes and 30 patients with type 2Y diabetes     will be identified. A Sustacal challenge test will be done in patients with a suspected     diagnosis of type 2Y in order to confirm the clinical diagnosis. Parents will be contacted by     phone for a detailed pedigree intake. Type 1 and type 2Y patients will be compared for each     of the studied features. A retrospective review of diabetes type 2 therapies used in type 2Y     patients will be undertaken through further examination of the medical records in order to     compare insulin treatment to oral agents. We will also test a subset of the patients for the     gene identified in adult Hispanics with type 2 diabetes.   "
164994|NCT00004573|"     The overall purpose of this research is to develop and use a blood test to better understand     how quickly the viral drug ganciclovir works to clear infection with the CMV virus     (Cytomegalovirus) when it occurs. This test will potentially let doctors know early in the     course of therapy when a virus is not responding well to the therapy and could therefore be     resistant to the drug. The target population of this study will be primarily kidney and lung     transplant patients with CMV detected in the blood, although other patients may also be     included if they meet criteria. The study will be divided into two phases. Phase I will     evaluate a small number of exploratory patients initiating ganciclovir therapy and will     require frequent blood sampling to obtain detailed information regarding the kinetic response     of the virus to therapy. This information will be analyzed to help guide decisions regarding     the number and frequency of blood samples needed in the larger phase II portion of the study.     Strains will be characterized using phenotypic and genotypic methods to determine the     presence or absence of mutations potentially responsible for the resistance.   "
165007|NCT00004604|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing.      PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients     who have metastatic cancer that has not responded to previous treatment.   "
165037|NCT00004685|"     OBJECTIVES: I. Determine whether albuterol increases strength in patients with     facioscapulohumeral dystrophy as measured by quantitative voluntary isometric contraction     testing.      II. Determine whether albuterol increases muscle mass in this patient population as     determined by 24 hour urinary creatinine excretion and dual energy x-ray absorptiometry     (DEXA).      III. Examine the long term safety of albuterol in this patient population.   "
164995|NCT00004574|"     This study will determine whether short term intravenous infusion of vitamins A and E in     patients with abetalipoproteinemia can reverse disease symptoms in these patients.     Abetalipoproteinemia is an inherited metabolic defect that prevents fat-soluble vitamins,     such as A and E, from being absorbed from the intestines into the bloodstream and from being     secreted by the liver. The deficiencies of vitamins A and E can result in severe vision     impairment and a gait disorder. Treatment with megadoses of these vitamins, taken by mouth,     may delay or arrest symptoms, but many continue to progress.      For this study, a single patient with moderately severe eye and neurological defects will be     given essential fatty acids and fat soluble vitamins directly through a vein (intravenously)     using FDA-approved replacements with a fat emulsion and multivitamins containing fat-soluble     vitamins. This route of administration will bypass the digestive tract, where the absorption     problem occurs. The infusions will be given twice a week for one month and then weekly for     another month. Blood tests will be done weekly to measure blood lipids (fatty acids and other     substances), cell counts, and vitamin levels. Eye and neurological examinations will be done     once a month.   "
164996|NCT00004575|"     This study will investigate the effect of the drug miconazole on blood vessel dilation.     Miconazole stops production of EDHF, a substance that causes arteries to dilate. EDHF is     produced by the cells that line blood vessels.      Normal volunteers between the ages of 21 to 60 may participate in this study. Candidates will     be screened for eligibility with a medical history, physical examination, electrocardiogram     and routine laboratory tests. Those enrolled will be injected with miconazole to study its     effects on blood vessels.      Study participants will take three aspirin tablets. After administration of a local     anesthetic, small tubes will be inserted through a needle into the artery and vein of the     forearm. These will be used to measure blood pressure and to draw blood samples during the     study. Forearm blood flow will be measured using pressure cuffs placed on the wrist and upper     arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are     inflated, blood will flow into the arm, stretching the strain gauge, and the flow measurement     will be recorded.      Small doses of four drugs-bradykinin, sodium nitroprusside, miconazole, and LNMMA-will be     given through the arterial catheter. Bradykinin stimulates the release of EDHF and can lower     blood pressure. Sodium nitroprusside causes blood vessels to dilate and is used to treat high     blood pressure and heart failure. Miconazole is commonly prescribed to treat various     infections, including vaginal yeast infections, jock itch and athlete's foot. In much higher     doses, it is used to treat fungal infections that have spread to the lungs, brain, kidneys,     or bladder. LNMMA inhibits production of nitric oxide, another substance produced by the     lining cells of blood vessels.      Blood flow will be measured throughout the study, which will last approximately 3 hours.   "
164997|NCT00004576|"     This study will test the effectiveness of an experimental drug called LY300164 on improving     Parkinson's disease symptoms, such as movement impairments and tremor, as well as involuntary     movements produced by long-term treatment with levodopa.      Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 75     years of age may be eligible for this 8-week study. Participants will have a complete medical     history and physical examination, including blood tests and an electrocardiogram, and     possibly brain magnetic resonance imaging (MRI), CT scan, and chest X-ray.      Patients will stop taking all anti-parkinsonism medications except levodopa (Sinemet) and the     experimental drug during the study. For the first 1 to 3 days, patients will be in the     hospital for a levodopa dose-finding procedure. For this study, levodopa is infused through     a vein for up to 8 hours, with symptoms monitored frequently to determine the doses that will     produce two results: 1) the dose that is less than what is needed to relieve symptoms, and 2)     the dose that relieves symptoms, but may produce dyskinesias.      When these dose rates are determined, patients will begin treatment in one of two groups. One     will take LY300164 3 times a day, along with levodopa, for 3 weeks. The second group will     take placebo tablets (a look-alike tablet with no active ingredient) and levodopa on the same     schedule as the LY300164 group. A brief medical examination and routine blood and urine tests     will be done weekly. The drug dose will be increased every 3 to 4 days until significant side     effects occur or the maximal dose is reached. Patients will be closely monitored for 4 hours     after every increase. At the end of the 3 weeks, or when the maximal dose is reached,     patients will be readmitted to the hospital for 2 to 3 days for a second levodopa     dose-finding study, while continuing on LY300164 or placebo. After this test, patients will     resume taking levodopa and the experimental drug or placebo as before for another 2 weeks.      At the end of the 2-weeks, the entire procedure will be repeated in both groups, but the     treatments will be switched-that is, the patients who were taking LY300164 will now take     placebo, and the patients who took placebo will now take the drug. At the end of the second 3     weeks, the levodopa infusion procedure will be repeated once more.      Throughout the study, parkinsonism symptoms and dyskinesias will be evaluated and blood     samples will be drawn periodically to measure drug levels.   "
164998|NCT00004577|"     The purpose of this investigation is to develop improved magnetic resonance imaging (MRI)     techniques and hardware for studying brain function. MRI is a diagnostic tool that provides     information about brain chemistry and physiology. This study will evaluate new MRI methods     for monitoring blood flow to regions of the brain in response to simple tasks. The MRI     machine used in this study is more powerful than those in most hospitals, permitting a higher     visual resolution.      Normal healthy volunteers over 18 years old may be eligible for this study. Candidates will     be screened with a medical history and questionnaire, and a neurological examination. Study     participants will have a yearly MRI scan. For this procedure, the subject lies on a stretcher     that is moved into a donut-shaped machine with a strong magnetic field. A lightweight     circular or rectangular coil a device that improves the quality of the images may be placed     on the head. The scan time varies from 20 minutes to 3 hours; most scans last between 45 and     90 minutes. During the scan, the subject may perform simple tasks, such as listening to     tapes, tapping a finger, moving a hand, watching a screen, or smelling a fragrance. More     complex tasks may require thinking about tones or pictures and responding to them by pressing     buttons.      Information from this study will be used to develop better imaging methods that will, in     turn, permit a greater understanding of normal and abnormal brain behaviors.   "
164999|NCT00004578|"     To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when     administered orally in antiretroviral-HIV-1 infected subjects.   "
165000|NCT00004579|"     The purpose of this study is to see whether an HIV vaccine, ALVAC vCP205, is safe and can     prevent HIV infection. The vCP205 vaccine will be tested with another vaccine, gp160MN/LAI-2.   "
165001|NCT00004580|"     The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir     combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected     patients who previously have taken protease inhibitors. This study also examines how the body     handles this combination of anti-HIV drugs.   "
165002|NCT00004581|"     The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug     combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2     nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI).     One combination will include a new protease inhibitor, ABT-378, combined in a capsule with     ritonavir (RTV).   "
165003|NCT00004582|"     The purpose of this study is to see if ABT-378/ritonavir plus efavirenz is safe and effective     in lowering the amount of HIV in the blood of patients who have been treated with more than 1     protease inhibitor (PI).   "
165018|NCT00004647|"     OBJECTIVES:      I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain     in patients with diabetic neuropathy.   "
165065|NCT00005468|"     To investigate the variability of lipids and specifically the effects of stress on serum     triglyceride levels, total cholesterol, HDL, and LDL in a 2.5 year epidemiological study.   "
165008|NCT00004635|"     This multi-center study will evaluate whether thalidomide can improve the effectiveness of     the drugs leuprolide or goserelin in treating testosterone-dependent prostate cancer.     Leuprolide and goserelin-both approved to treat prostate cancer-reduce testosterone     production, which, in most patients, reduces the size of the tumor. Thalidomide, a drug used     for many years to treat leprosy, blocks the growth of blood vessels that may be important to     disease progression.      Patients 18 years or older with testosterone-dependent prostate cancer that has persisted or     recurred after having had surgery, radiation therapy, or cryosurgery, but whose disease has     not metastasized (spread beyond the prostate) may be eligible for this study. Candidates are     screened with a medical history and physical examination, including blood tests, bone and     computed tomography (CT) scans or other imaging studies.      Study participants are randomly assigned to one of two treatment groups. One group receives     leuprolide or goserelin followed by thalidomide; the other receives leuprolide or goserelin     followed by placebo (a look-alike pill with no active ingredients). Patients in both groups     receive an injection of leuprolide or goserelin once a month for 6 months. After that time     they take four capsules of either thalidomide or placebo once a day and remain on the drug     until their prostate-specific antigen (PSA) level returns to what it was before beginning     leuprolide or goserelin or to 5 nanograms per liter, whichever is lower.(PSA is a protein     secreted by the prostate gland. Monitoring changes in levels of this protein can help     evaluate tumor progression). At this point the entire procedure begins again, starting with     leuprolide or goserelin treatment, but the experimental drug is switched; patients originally     treated with thalidomide are crossed over to placebo, and patients originally treated with     placebo are crossed over to thalidomide.      Patients are monitored periodically with the following tests and procedures:      Medical histories and physical examinations. Blood and urine tests to monitor thalidomide and     PSA levels, the response to treatment, and routine laboratory values (e.g., cell counts and     kidney and liver function).      Computed tomography (CT) and bone scans, and possibly other imaging tests to assess the     tumor.      Electromyography (EMG) and nerve conduction studies, as needed. For electromyography, a thin     needle is inserted into a few muscles and the patient is asked to relax or to contract the     muscles.   "
165009|NCT00004637|"     This is a study to see if vitamin E helps children with epilepsy have fewer seizures. About     20-30% of children with epilepsy do not have adequate seizure control with established     antiepileptic drugs (AEDs). Other options for patients with uncontrolled epilepsy are newer     antiepileptic medications, ketogenic diet and surgery. However, a small percentage of     patients are candidates for these options. Therefore, additional treatments are needed to     improve seizure control in patients with uncontrolled epilepsy. Animal studies have shown an     association between vitamin E supplementation and seizure reduction. A study in children also     showed that vitamin E helped reduce seizures. However, a similar study in adults did not show     a reduction in seizures with vitamin E supplementation. Therefore, this research study is     being done to help define vitamin E's usefulness and safety as a treatment for epilepsy.     Fifty patients will be recruited from the Children's Epilepsy Program at The Children's     Hospital in Denver, Colorado. Qualifying patients will have a confirmed diagnosis of epilepsy     that is currently uncontrolled with standard AEDs. The study period is 6 months and includes     the following: Baseline period (1 month), Arm I (2 months), Wash-out period (1 month), and     Arm II (2 months). Patients must have been on the same AEDs for 2 months before enrollment.     All medications and complementary therapies must remain constant throughout the study. If at     any point the physician feels it is not best for the patient to continue the study they will     be discontinued. Before the study starts, study participants will be asked about seizure     activity, what they eat and about any complementary and/or alternative medicine they may use.     The study is two phases. Study participants will be given either vitamin E or placebo (fake     pill/liquid) in each phase of the study. They will receive both vitamin E and placebo during     the study. Which phase they receive vitamin E and placebo will be decided by chance (similar     to rolling dice). Study participants will take liquid vitamin E or placebo two times per day.     The study participants and study doctors will not know who is taking vitamin E and who is     taking placebo. Study participants will come to the hospital for 3 outpatient and 2 inpatient     visits. Health-related quality of life questionnaires will be filled out and blood will be     drawn at three of the visits. Seizure diaries will be maintained throughout the study.   "
165010|NCT00004638|"     Chronic sinusitis is a common pediatric disease; it ranks among the top five infectious     diseases of the upper respiratory tract. Its treatment is limited and may be due largely in     part to a lack of understanding of its cause. The investigators have preliminary data to     support the notion that pediatric chronic sinusitis is a distinct disease, different from     acute sinusitis and adult chronic sinusitis. We are proposing to perform pathogenesis studies     in children with chronic sinusitis. Specifically, we wish to elucidate the microbiologic     features and immunologic factors involved in the formation of this disease. The study plan     calls for microbiologic (bacterial, viral, and fungal) and immunologic (inflammatory     mediators and leukocyte populations) data to be evaluated through a maxillary sinus washing     and mucosal biopsies. Four populations will be studied and they are: 10 children with chronic     sinusitis, 5 children with acute sinusitis (positive control), 5 children without sinusitis     (negative control) and 5 adults with chronic sinusitis (positive secondary control).   "
165011|NCT00004639|"     Compare the outcome of two primary surgeries techniques (von Langenbeck and Furlow double     z-plasty) performed on children with cleft lip/palate to determine if one results in     significantly better velopharyngeal competency for speech.   "
165012|NCT00004640|"     The purpose of this study is to determine if regular rinsing with chlorhexidine is effective     as a long-term preventive method for reducing the incidence of tooth loss in low income older     adults. The true end-point of the study is tooth loss after five years of regular rinsing     with chlorhexidine or a placebo; surrogate endpoints are periodontal disease, root and     coronal decay.   "
165013|NCT00004642|"     OBJECTIVES: I. Evaluate the safety, tolerance, and potential efficacy of 3 doses of human     anti-cytomegalovirus (CMV) monoclonal antibody SDZ MSL-109 (MOAB MSL-109) in the treatment of     newborns with congenital CMV infection and no central nervous system disease.      II. Determine the relationship between plasma concentrations of MOAB MSL-109 and therapeutic     outcome.      III. Determine whether MOAB MSL-109 influences the antibody response and clearance of virus     from the urine.   "
165014|NCT00004643|"     OBJECTIVES: I. Evaluate the toxicity of cytarabine in patients with refractory systemic lupus     erythematosus.      II. Evaluate objective disease parameters, including serum complement levels, anti-DNA     antibody titers, sedimentation rate, and the systemic lupus activity measure in these     patients.   "
165015|NCT00004644|"     OBJECTIVES: I. Evaluate whether high-dose acyclovir decreases acute and long-term morbidity     and mortality in neonates with central nervous system or disseminated herpes simplex virus     (HSV) infection.      II. Evaluate whether high-dose acyclovir is safe and tolerated in the newborn. III. Assess     resistance to antiviral medication. IV. Amplify disease classification for the purpose of     predicting prognosis. V. Assess any changes in viral excretion patterns. VI. Evaluate whether     antigens and antibodies specific for HSV glycoproteins within the cerebrospinal fluid (CSF)     predict long-term neurologic outcome.      VII. Evaluate whether specific antigens and antibodies in the CSF appear late after treatment     and are indicative of insidious reactivation of virus in the brain.   "
165016|NCT00004645|"     OBJECTIVES:      I. Evaluate the effectiveness of plasma exchange in the treatment of acute severe attacks of     inflammatory demyelinating disease in patients who have failed intravenous steroid therapy.   "
165017|NCT00004646|"     OBJECTIVES: I. Characterize the effect of prednisone on muscle protein metabolism in patients     with Duchenne muscular dystrophy.      II. Determine whether prednisone changes levels of insulin-like growth factor 1, growth     hormone, and insulin.      III. Characterize the effect of prednisone on muscle morphometry and muscle localization of     utrophin.      IV. Compare the prednisone response in patients with Duchenne muscular dystrophy to that seen     in normal individuals and in patients with facioscapulohumeral dystrophy.   "
165019|NCT00004648|"     OBJECTIVES: I. Examine screening modalities for pulmonary vascular arteriovenous malformation     (PAVM) in individuals with endoglin mutations.      II. Examine the prevalence of cerebral arteriovenous malformations (CAVM) in individuals with     hereditary hemorrhagic telangiectasia (HHT).      III. Investigate whether modifier genes exist that determine which individuals with HHT due     to an endoglin mutation develop PAVMs and which develop CAVMs.      IV. Investigate the frequency of cardiac valve abnormalities in individuals affected with HHT     due to an endoglin mutations.   "
165020|NCT00004649|"     OBJECTIVES: I. Collect data regarding the natural history of hereditary hemorrhagic     telangiectasia (HHT).      II. Establish genotype-phenotype correlations in HHT. III. Create a database of information     for researchers throughout the world.   "
165021|NCT00004650|"     OBJECTIVES: I. Quantify periodontal alveolar bone loss rates in postmenopausal women.      II. Evaluate the effects of estrogen on alveolar bone loss rates in these patients.      III. Determine whether changes in periodontal bone mass relate to bone mass changes in other     skeletal sites in these patients.   "
165022|NCT00004652|"     OBJECTIVES: I. Determine whether the time period between randomization and endpoint is longer     in the short term pimozide therapy or longer term therapy in patients with Tourette syndrome.      II. Determine whether tic severity, medication side effects, academic performance and     psychosocial functioning are better in the short term pimozide therapy or longer term     pimozide therapy.   "
165023|NCT00004654|"     OBJECTIVES: I. Evaluate migraine prophylaxis with soy protein isolate in patients with     hereditary hemorrhagic telangiectasia.      II. Assess whether soy protein isolate reduces the frequency and severity of epistaxis and     gastrointestinal bleeding in these patients.   "
165024|NCT00004656|"     OBJECTIVES: I. Determine dietary macronutrient intake in children with Rett syndrome and in     healthy controls.      II. Measure sleeping and awake metabolic rates in various positions, i.e., reclining,     sitting, and standing, by whole-room indirect calorimetry and isotope dilution.      III. Quantify activity patterns by time-motion studies using 24-hour activity records and     12-hour videotaping.      IV. Correlate 24-hour activity patterns with 24-hour heart rate telemetry and short-term     oxygen consumption.      V. Estimate 24-hour fecal and urinary energy losses. VI. Determine body composition by     clinical anthropometry, whole-body potassium counting, and total-body electrical conductance.      VII. Calculate apparent energy needs based on measurement of energy intake and expenditure.   "
165025|NCT00004658|"     OBJECTIVES: I. Evaluate the efficacy of oral ribose in patients with a complex     5'-nucleotidase syndrome who have not received uridine (UR) and thymidine (TDR).      II. Evaluate the efficacy of UR/oral ribose and UR/TDR. III. Evaluate the efficacy of oral     ribose given in combination with UR/TDR.   "
165026|NCT00004659|"     OBJECTIVES: I. Evaluate whether stereotactic radiosurgery provides local control at multiple     sites in patients with primary or metastatic brain tumors, controlled systemic disease, and     preserved neurologic function.      II. Examine survival, clinical outcome, and local tumor imaging response in these patients.   "
165027|NCT00004660|"     OBJECTIVES: I. Evaluate the effects of 20 Gy of external-beam radiotherapy to 1 orbit vs. the     untreated orbit at 3 and 6 months after therapy in patients with Graves' ophthalmopathy.      II. Evaluate whether 20 Gy of external-beam radiotherapy delivered to the second orbit 6     months later in the course of the disease produces effects of equal magnitude to those     observed when the first orbit was treated.      III. Relate the magnitude of treatment effects to the time since onset of eye symptoms.      IV. Evaluate whether characteristics of radiation retinopathy are present 3 years after     orbital radiotherapy.   "
165028|NCT00004661|"     OBJECTIVES:      Determine the relationship between serum calcium concentrations and parathyroid hormone     secretion in patients with pseudohypoparathyroidism.   "
165029|NCT00004662|"     OBJECTIVES:      I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with     active systemic lupus erythematosus.   "
165030|NCT00004663|"     OBJECTIVES: I. Evaluate whether pregnancy is an independent risk factor that affects disease     activity in women with systemic lupus erythematosus.      II. Evaluate whether maternal disease activity is a risk factor for adverse pregnancy     outcome.   "
165031|NCT00004664|"     OBJECTIVES: I. Evaluate the effect of aerobic exercise and progressive resistance plus     megestrol acetate on lean body mass of patients with human immunodeficiency virus-related     weight loss (HIV-wasting).      II. Evaluate whether exercise acutely alters immune function. III. Evaluate whether long-term     exercise improves immunocompetence. IV. Evaluate the accuracy of multifrequency bioelectrical     impedance spectral analysis in measuring body composition.      V. Assess the impact of these therapies on quality of life. VI. Evaluate the effect of these     therapies on the balance of energy intake and energy expenditure.   "
165032|NCT00004665|"     OBJECTIVES:      I. Evaluate the long-term safety and tolerance of a synthetic formulation of     dehydroepiandrosterone, GL701, in patients with systemic lupus erythematosus who have     completed a prior GL701 protocol.   "
165033|NCT00004667|"     OBJECTIVES: I. Evaluate the effect of a new von Willebrand factor concentrate on bleeding     time, in vivo recovery, and circulating half-life of the infused factor in patients with von     Willebrand's disease.      II. Assess the safety of von Willebrand factor in these patients.   "
165034|NCT00004669|"     OBJECTIVES: I. Estimate the efficacy of cortisol replacement therapy during the first 12 days     of life for prevention of bronchopulmonary dysplasia.      II. Estimate the effect of cortisol replacement therapy on the signs of acute adrenal     insufficiency.      III. Evaluate the effects of cortisol replacement therapy on adrenal hormone concentrations     and on the ability of the adrenal gland to respond to ACTH.      IV. Determine the effect of this replacement therapy on markers of inflammation in lung     lavage fluid and peripheral blood leukocytes.   "
165035|NCT00004670|"     OBJECTIVES:      I. Evaluate the safety and efficacy of pallidotomy immediately following 3 preoperative     assessments vs. delayed pallidotomy following 6 months of standard medical therapy in     patients with Parkinson disease.   "
165036|NCT00004682|"     OBJECTIVES:      I. Determine whether intravenous immunoglobulin is an effective therapy for patients with     mild or moderate myasthenia gravis.   "
165066|NCT00005469|"     To examine a school-based population of children for maturational changes in blood pressure     and cardiac structures.   "
165038|NCT00004686|"     OBJECTIVES: I. Compare the long term outcomes in patients with giant cell arteritis after     glucocorticoid treatment with or without methotrexate.      II. Compare remission relapse rates in these patients after glucocorticoid therapy with or     without methotrexate.      III. Determine whether adjunctive use of methotrexate lowers cumulative dose and duration of     glucocorticoid therapy and whether there is less treatment related morbidity and mortality.      IV. Demonstrate the feasibility of long term, double blind, placebo controlled, randomized,     multicenter trials for treatment of systemic vasculitides.   "
165039|NCT00004688|"     OBJECTIVES:      I. Assess the clinical response of patients with refractory or recurrent brain neoplasms     treated with carmustine, streptozocin, and mercaptopurine.   "
165040|NCT00004689|"     OBJECTIVES: I. Determine the bacteriological activity of amithiozone against Mycobacterium     avium complex (MAC) pulmonary disease.      II. Define the ability of amithiozone to improve clinical outcomes in patients with MAC     infection.      III. Determine the safety and tolerance of amithiozone with chronic dosing in these patients.      IV. Assess the contribution of clarithromycin, streptomycin, rifampin, ethambutol, kanamycin,     and amithiozone in the treatment of pulmonary MAC infection.   "
165041|NCT00004690|"     OBJECTIVES: I. Compare the safety and efficacy of monolaurin cream versus a placebo vehicle     cream in suppressing the signs of nonbullous congenital ichthyosiform erythroderma.      II. Assess the incidence of posttreatment rebound or recrudescence in patients with     congenital ichthyosis.      III. Evaluate the long term safety of monolaurin cream with whole body application in these     patients.   "
165042|NCT00004694|"     OBJECTIVES:      I. Determine the safety and efficacy of inhaled and subcutaneously administered heparin in     the treatment of hereditary angioedema.   "
165043|NCT00004695|"     OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can     reduce the number of infections in patients with common variable immunodeficiency.      II. Determine whether this therapy can improve lung functions in these patients with     pulmonary impairment.   "
165044|NCT00005446|"     To investigate the relation between endogenous levels of estrogen in postmenopausal women and     the subsequent development of coronary heart disease.   "
165045|NCT00005447|"     To provide new scientific information regarding the role of physical activity in primary and     secondary disease prevention, particularly coronary heart disease (CHD).   "
165046|NCT00005448|"     To investigate in pregnant women the adverse pulmonary effects of magnesium sulfate (MgSO4),     a commonly used drug for tocolysis or arrest of labor.   "
165047|NCT00005449|"     To examine the role of social support in attenuating ischemic responses to psychological     stress, both in the laboratory and during daily life.   "
165048|NCT00005450|"     To develop an epidemiologic model to estimate the benefits, costs and risks of disease     prevention in the elderly.   "
165049|NCT00005451|"     To design Computer Aided Telephone Interviewing (CATI) software tools for survey research.   "
165050|NCT00005452|"     To develop TI (pronounced 'T-sub-I'), a personal computer program to analyze time-varying     data generated by periodic patient reports, repeatedly-observed disease signs, or serial     biomarkers to study chronic disease.   "
165051|NCT00005453|"     To examine the effects of two strategies of inducing enhanced adherence to medication in the     context of a clinical trial: habit training versus habit training plus problem solving.   "
165052|NCT00005455|"     A detailed review was made of data pertinent to the occurrence of chronic Chagas disease in     the United States.   "
165053|NCT00005456|"     To study calcium metabolism and the renin-angiotensin system in hypertensive and normal     pregnancy.   "
165054|NCT00005457|"     To enhance statistical methods for epidemiological studies by extending the Disturbed Highest     Derivative Polynomial (DHDP) to models for binary-logistic and Poisson data and by including     random subject effects in the Gaussian model.   "
165055|NCT00005458|"     To re-examine the relationship between suppressed anger, elevated blood pressure and     all-cause as well as coronary heart disease (CHD) mortality using data from the Life Change     Event Study (LCES) conducted on a representative sample of the Tecumseh Community Health     Study (TCHS), n=696, men and women, aged 30-69 in 1971-1972.   "
165056|NCT00005459|"     To investigate whether women with Polycystic Ovary syndrome (PCOS) have evidence of an     increased prevalence rate of subclinical atherosclerosis as measured by the presence of     plaque, increased intima-medial carotid artery wall thickness and lower brachial artery flow     mediated vasodilation.   "
165057|NCT00005460|"     To evaluate factors associated with cardiovascular morbidity and mortality in a cohort of 795     men and women aged 75 years or older at the time of a comprehensive examination conducted     between 1984 and 1987.   "
165058|NCT00005461|"     To investigate the determinants of valid symptom perception in childhood asthma and the     relation of symptom perception to asthma morbidity.   "
165059|NCT00005462|"     To identify individual genes that contribute to variation in susceptibility to coronary heart     disease (CHD) in Mexican Americans. The program project grant supports the San Antonio Family     Heart Study, the first comprehensive genetic epidemiological study of atherosclerosis and its     correlates in Mexican Americans.   "
165060|NCT00005463|"     To evaluate the cost-effectiveness of cholesterol-lowering strategies in the United States     population. The study used the Coronary Heart Disease (CHD) Policy Model, a state-transition     computer simulation model used to obtain forecasts of the public health impact and economic     cost of CHD in the United States population.   "
165061|NCT00005464|"     To perform extensive analyses of data from the Dietary Intervention Study of Hypertension     (DISH)..   "
165062|NCT00005465|"     To map the major gene influencing low-density lipoprotein subclass phenotypes, denoted     atherogenic lipoprotein (ALP) phenotypes, with a long term goal of cloning the ALP gene and     understanding its role in genetic susceptibility to atherosclerosis.   "
165063|NCT00005466|"     To estimate the relative risks of acute myocardial infarction (MI) and of stroke in     postmenopausal users of estrogen/progestogen (E/P) combinations and to estimate the relative     risks of MI and of stroke in users of estrogen alone.   "
165064|NCT00005467|"     To develop a clinical severity index that could prospectively identify sickle cell disease     patients who were at high risk for a turbulent clinical course and a poor prognosis.   "
165071|NCT00005758|"     The purpose of this study is to look at the effects of the HIV vaccine Remune on viral load     (level of HIV in the blood) and on the way the immune system responds to HIV. This study will     also try to see if the effects of the vaccine are different in patients entering the study     with a viral load below 50 copies/ml compared to those who have a viral load from 50 to 500     copies/ml. (This study is currently being redesigned and the purpose may be revised.)     Treatment with anti-HIV drugs does not always keep HIV viral load undetectable (so low that     it cannot be measured). This study originally added an HIV vaccine called Remune to treat     patients. Remune was thought to reduce viral load and improve immune responses. However, new     information suggests that Remune may not be as effective as was first believed. The study has     been changed to follow people already in the study and to let people enroll only if they     participate in the substudy. The substudy will look at the effect of another HIV vaccine,     vCP1452, on the immune response and how it works in combination with Remune. Information     about the safety of these vaccines in HIV-positive patients will be gathered.   "
165072|NCT00005760|"     This study is for women who have already decided to undergo liposuction at Georgetown     University Medical Center in Washington, D.C. To take part in this study, a woman must first     meet with the plastic surgeons there, and be accepted by them to have liposuction. This study     will investigate whether large volume liposuction improves risk factors for heart disease in     overweight women with type 2 (adult onset) diabetes, impaired glucose tolerance, or elevated     blood insulin levels. Large volume liposuction is the surgical removal of at least 10 pounds     (4.5 kg) of body fat, usually from the abdomen, hips or chest. Risk factors for heart disease     include high blood pressure and elevated levels of blood lipids (cholesterol and     triglycerides), blood glucose (sugar), and blood insulin. Subjects who participate in all     parts of this study will receive a total of $930.00.      Overweight women 18 years or older with high blood insulin levels, impaired glucose     tolerance, or type 2 diabetes, who are planning to have large volume liposuction performed at     Georgetown University Medical Center in Washington, D.C., may be eligible for this study. For     a subject to be accepted into this study, she must first meet with the plastic surgeons at     Georgetown University Medical Center, and they have to agree to perform large volume     liposuction. The decision that someone is suitable for liposuction is not under the control     of the NIH or of any NIH investigator.      Those enrolled will undergo the following procedures at four separate times - before     undergoing liposuction, 4 weeks after surgery, 4 months after surgery and 1 year after     surgery:        -  Body measurements - taken with calipers to measure several skinfold thicknesses (the          width of a fat fold) and with a tape measure to measure the circumference of parts of          the body.        -  Urine sample and 6-hour urine collection - to test for pregnancy and to evaluate kidney          function.        -  Glucose tolerance test - measures insulin sensitivity and how the body uses sugar, how          well insulin works, and insulin sensitivity. The procedure involves placement of two          catheters (thin, flexible tubes) through a needle into a vein in each arm. Sugar water          is infused into one catheter and 20 minutes into the test a small amount of insulin is          injected. Blood samples are drawn from the other catheter at frequent intervals for a          total of 5 hours.        -  Electrocardiogram (ECG) and echocardiography - measure the heart's electrical activity          and function.        -  Abdominal computerized tomography (CT) scan - produces images for measuring body fat in          the abdomen. (not done at the 4-week visit). Takes about half an hour to complete.        -  DXA X-ray - measures body fat, muscle and bone mineral content. Takes about half an hour          to complete.        -  Bod Pod - capsule-like device used to determine the proportion of body weight composed          of fat and non-fat tissue. Takes less than 10 minutes        -  Bioelectric impedance analysis device - measures the proportions of body fat based on          electrical conduction of a small electric current. Takes 2-3 minutes.        -  24-hour blood pressure monitoring - a device attached to a blood pressure cuff strapped          to the arm measures blood pressure every 15 to 30 minutes continuously for 24 hours.        -  Vascular reactivity tests - a blood pressure cuff is inflated for about 4 minutes before          deflating, providing information on the function of the small blood vessels in the skin,          as well as an idea of the function level of small blood vessels elsewhere in the body.          Takes half an hour.        -  Blood samples - collected to evaluate kidney and liver function and to measure body          lipids, such as cholesterol, minerals, and other substances.   "
165073|NCT00005761|"     This study will determine whether certain factors in the blood are associated with the     severity of diabetic retinopathy.      Patients age 10 years and older with diabetes mellitus and diabetic retinopathy may be     eligible for this study. Those enrolled will represent a range of diabetic retinopathy from     minimal to severe. Participants will undergo the following procedures:        -  medical history        -  thorough eye examination        -  photographs of the eye        -  blood tests to measure blood lipids (cholesterol and triglycerides) and serum creatinine          (for kidney function)        -  blood tests to measure levels of blood factors (cell adhesion molecules, chemokines and          vascular endothelial growth factor) that may be related to the progression of diabetic          retinopathy        -  blood pressure measurement        -  urinalysis      This study may lead to a better understanding of how diabetic retinopathy develops and     progresses.   "
165074|NCT00005762|"     The purpose of this study is to measure the blood levels of amprenavir (APV) alone, APV     combined with efavirenz (EFV), and APV/EFV combined with a third drug (nelfinavir [NFV],     indinavir [IDV], ritonavir soft gel capsules [RTV sgc], or saquinavir soft gel capsules [SQV     sgc]).      Anti-HIV therapy with 3 or 4 drugs is currently the recommended approach for treating HIV     infections. Doctors need to know the best dosages of certain drugs when they are given in     combination. This study will measure the blood levels of APV alone, APV combined with EFV,     and APV/EFV plus a second PI in healthy volunteers. It will study the safety and tolerance of     these drugs.   "
165075|NCT00005763|"     To coordinate an international study on the relationships between population mean sodium and     potassium intake and blood pressure.   "
165076|NCT00005764|"     The purpose of this study is to see if the findings of increased lactic acid and abnormal fat     distribution get better when d4T is replaced with abacavir, abacavir plus lamivudine, or     Combivir (a pill containing lamivudine plus zidovudine) in HIV-positive patients taking     anti-HIV therapy including stavudine (d4T).   "
165077|NCT00005765|"     The objective of this protocol is to examine the utility of behavioral economics for     understanding reinforcer interactions as they pertain to drug self-administration. In a     series of 6 experiments, the researchers will attempt to quantify the effects of     qualitatively different reinforcers (money, cigarettes, alcohol, nicotine gum) and their     interactions. This work represents a continuation of research by this investigator in the     area of addiction and pharmacology.   "
165078|NCT00005766|"     The objective of this study is to determine whether creatine slows disease progression in     subjects with amyotrophic lateral sclerosis (ALS). ALS is a progressive uniformly lethal     neurodegenerative disorder for which there is no known cure. Recent genetic and biochemical     studies implicate free radical toxicity, glutamate excitotoxicity and mitochondrial     dysfunction as possible causes of familial ALS (FALS) and sporadic ALS (SALS). It has been     hypothesized that in ALS there may be involvement of oxidative free radical damage and     impaired mitochondrial energy metabolism that could in turn lead to excitotoxic cell death.     Creatine, an agent that improves mitochondrial function, has been shown to be neuroprotective     in animal models of ALS and Huntington's disease.      This study is a double-blind, randomized, placebo-controlled trial of the safety and efficacy     of creatine in patients with ALS enrolled at sites distributed throughout the United States,     including Northeast ALS (NEALS) sites. The study will provide preliminary data on the safety     and efficacy of creatine in ALS. If creatine slows disease progression in ALS and is well     tolerated, a phase 3 study with survival as the primary outcome measure will be initiated.      114 eligible subjects will be randomized to receive treatment for 6 months of (1) active     creatine or (2) placebo. After randomization, subjects will be followed prospectively for 6     months. The primary outcome measure for the study is the change in upper extremity motor     function after 6 months of experimental therapy as tested with the Tufts Quantitative     Neuromuscular Exam. Strength in eight arm muscles will be measured (bilateral shoulder and     elbow flexion and extension). Secondary outcome measures include grip strength, motor unit     number estimates (MUNE), the ALS functional rating score-revised (ALSFRS-R), and rate of     change of a well established biochemical marker of oxidative damage to DNA (8OH2'dG levels in     urine), and the safety and tolerability of creatine.   "
165079|NCT00005767|"     This protocol seeks to define aspects of intestinal and hepatic uptake and metabolism of     several amino acids. The major hypothesis to be tested is that the splanchic bed (intestine     and liver) conserves essential amino acids and metabolites while synthesizing and     metabolizing nonessential amino acids. The aims of the study include defining the relative     roles of enteral and hepatic extraction/metabolism in the disposition of glutamate, alanine,     methionine and other amino acids. Emphasis will also be placed on studies of the     transamination of alpha-ketoisocaproic acid (KIC) to leucine since this reaction is of     potential importance in the design of nutritional regimens for patients with renal disease.   "
165080|NCT00005768|"     This study will examine whether estrogen administration in postmenopausal women can alter the     response to changes in brain chemistry brought about by dietary manipulation. Women who are     recently menopausal (50-60 yrs. of age) and over 20 years postmenopausal (>70 yrs. of age)     will take estrogen or placebo for three months. At the end of that time they will participate     in three challenges using dietary techniques to briefly change the relative amounts of     neurotransmitters in the brain that are believed to be related to mood regulation (serotonin,     dopamine, and norepinephrine). Previous research has shown that these dietary manipulations     can briefly produce negative changes in mood. The investigator hypothesizes that estrogen     administration will blunt or buffer these negative effects in a quantifiable way. The     investigator believes that this will provide a direct test of the ability of estrogen to     meaningfully change the brain chemistry of mood in a clinically measurable and positive way.     The proposed procedure will also allow assessment of the effects of estrogen on brain     neurotransmitter systems after many years of very low estrogen levels.   "
165081|NCT00005769|"     Considerable controversy exists regarding the effect of estrogen and progesterone on insulin     sensitivity in postmenopausal women. Thus, the goal is to examine the effect of estradiol and     progestin on in vivo insulin sensitivity and pathways of intracellular glucose metabolism in     postmenopausal women. This will be accomplished by examining the effects of unopposed     estrogen (CEE) or combination estrogen and progestin (CEE/MPA) versus placebo therapy in 30     early menopausal women (defined from 6 months to 3 years post-cessation of menses). Women     will be treated for 16 weeks and the outcome measures will be: 1) insulin sensitivity and     glucose oxidation as determined by euglycemic clamp, 2) assessments of insulin sensitivity on     muscle biopsy cultures with the primary endpoints being glucose uptake and glycogen     accumulation/synthesis, 3) protein levels of insulin action cascade steps based on muscle     biopsy Western blots.   "
165082|NCT00005770|"     During acupuncture treatment, acupuncture needles are inserted and manipulated until a     characteristic local tissue reaction termed de qi is observed. De qi can be perceived by     the acupuncturist in the form of needle grasp, a mechanical gripping of the needle by the     tissue. De qi is considered essential to the therapeutic effect of acupuncture. Therefore,     the investigator proposes that understanding this local tissue reaction will lead to an     understanding of how the therapeutic effect of acupuncture therapy arises. Specifically, it     is hypothesized that needle manipulation causes winding of collagen and elastic fibers around     the needle. This action induces tension in the collagen network surrounding the needling site     and results in a mechanical signal that is transduced into local cells. The objective of the     current work is to use ultrasound elastography, a recently developed ultrasound imaging     technique, to visualize and quantify changes in the elastic properties of skin and     subcutaneous tissue in 12 healthy human volunteers as a result of acupuncture needle     manipulation.   "
165083|NCT00005771|"     Recently, physical therapists have begun treating people who have mechanical low back pain,     hypothesized to be caused by segmental instability in the lumbar spine, with a very specific     exercise program consisting of trunk stabilization exercises. The theory behind the use of     trunk stabilization exercises to treat lower back pain is that active contraction of the     trunk local segmental muscles helps to control inter-segmental movement in the spine. The     initial trunk stabilization exercise that physical therapists teach patients is an abdominal     drawing in maneuver often called an abdominal hollowing exercise (AHE). A challenge for     physical therapists is to establish the most effective means of teaching people to contract     the relevant muscles needed to perform the AHE. The purpose of this study is to examine if     supplementing the typical clinical instruction for teaching the AHE with visual ultrasound     feedback to the patient is effective at reducing the length of time it takes an individual to     learn to perform an AHE.      Three groups of research volunteers will be taught how to do the AHE while receiving     different kinds of feedback about their performance in order to determine which type of     feedback is most effective in assisting people to learn the AHE. Group 1 will not receive any     feedback about performance; Group 2 will receive feedback from palpation and verbal     descriptive alone; and Group 3 will receive feedback from palpation, verbal descriptive     feedback, and real time ultrasound. For the initial test when subjects are learning the AHE,     the number of trials until the subject demonstrates his/her third correct AHE will be the     outcome variable. For the retention test, the outcome variable will be the percentage of     trials (out of ten) of correctly performed AHEs in the absence of visual, verbal or palpation     feedback.   "
165084|NCT00005772|"     This large multicenter trial tested whether cerebral cooling initiated within 6 hours of     birth and continued for 72 hours would reduce the risk of death and moderate to severe     neurodevelopmental injury at 18-22 months corrected age. Infants at least 36 weeks gestation     with an abnormal blood gas within 1 hour of birth, or a history of an acute perinatal event     and a 10-min Apgar score <5, or continued need for ventilation were screened. Following a     neurological exam, those with moderate to severe encephalopathy were randomized to a 72-hour     period of total body cooling (cooling blanket, followed by slow re-warming). The study was     conducted in two phases: Phase I (20 infants) were examined for the safety of an esophageal     temperature of 34-35 C; Phase II (main trial, 200 infants) were evaluated for the safety and     efficacy of an esophageal temperature of 33-34 C. Cardio-respiratory, electroencephalograms     (EEGs), renal, metabolic, and hematologic status, and esophageal and abdominal skin     temperature were monitored during the 72 hours of intervention. Surviving children were given     neurodevelopmental examinations at 18-22 months corrected age and again at school age (6-7     years of age).   "
165085|NCT00005773|"     This prospective, randomized controlled trial tested whether initiating iNO therapy earlier     would reduce death and reduce the use of extracorporeal membrane oxygenation (ECMO) --     temporary lung bypass -- therapy compared with the standard recommendation threshold. Infants     who were born at >34 weeks' gestation were enrolled when they required assisted ventilation     and had an oxygenation index (OI) >15 and <25 on any 2 measurements in a 12-hour interval.     Infants were randomized to receive either early iNO or to simulated initiation of iNO     (control). Infants who had an increase in OI to 25 or more were given iNO as standard     therapy. The neurodevelopment of the subjects were evaluated at 18-22 months corrected age.   "
165086|NCT00005774|"     Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is     associated with lung injury and nosocomial infection. Moderately premature infants with mild     respiratory distress do not routinely receive artificial surfactant early in their course of     treatment. This multi-center, randomized trial tested whether early surfactant therapy and     nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced     mechanical ventilation usage without added complications. Infants with mild to moderate     respiratory distress syndrome were enrolled in the trial and given either early     administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or     standard practice (surfactant according to current center practice, only after initiation of     mechanical ventilation), to see whether the experimental method would reduce the need for     subsequent mechanical ventilation.   "
165087|NCT00005775|"     This large multicenter double-masked clinical trial tested whether supplementation of     standard neonatal parenteral nutrition with glutamine would reduce the risk of death or     late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm)     infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or     TrophAmine supplemented with glutamine before 72 hours and continued until the infants are     tolerating full enteral feedings.   "
165088|NCT00005776|"     Respiratory failure in term newborns is associated with increased rates of death and     long-term neurodevelopmental problems. This large international multicenter trial randomized     newborns who had failed to respond to intensive care, including high levels of ventilator     support, to receive either inhaled nitric oxide (iNO) or 100 percent oxygen to test whether     iNO would decrease their risk of dying or requiring temporary lung bypass. Infants were     followed during their initial hospitalization; their outcome was assessed at 18 to 24 mos of     age.   "
165089|NCT00005777|"     This multicenter clinical trial tested whether minimal ventilation decreases death or BPD.     Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were     randomly assigned to minimal ventilation (partial pressure of carbon dioxide [PCO(2)] target     >52 mm Hg) or routine ventilation (PCO(2) target <48 mm Hg) and a tapered dexamethasone     course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was     death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were     recorded for 10 days; complications and outcomes were monitored to discharge. The infants'     neurodevelopment was evaluated at 18-22 months corrected age.   "
165090|NCT00005778|"     This study compares the effectiveness of high-dose cyclophosphamide treatment with the gold     standard treatment, monthly intravenous (IV) cyclophosphamide, in people with moderate to     severe lupus that does not respond to high-dose corticosteroid therapy. We will give patients     either IV cyclophosphamide (750 milligrams per square meter of body surface area) monthly for     6 months, followed by quarterly maintenance therapy, or high-dose IV cyclophosphamide (50     milligrams per kilogram body weight per day) for the first four days of the study. Patients     will be followed for 24 months after therapy.   "
165091|NCT00005779|"     The purpose of this study is to see if it is safe to give C4-V3, a possible HIV vaccine,     alone or in conjunction with 4 different doses of interleukin-12 (IL-12), to HIV-infected     patients who are taking anti-HIV drugs that have lowered the amount of HIV in patients'     blood. (This study has been changed so that vaccine is administered alone or with 4 different     doses of IL-12.) Immune cells known as cytotoxic T lymphocytes (CTLs) help destroy     HIV-infected cells. However, in most patients, CTLs decrease over time. This allows HIV     levels to rise and AIDS symptoms to develop. The C4-V3 vaccine contains small pieces of HIV     protein that can boost CTL levels, allowing the body's immune system to fight HIV. Giving     IL-12, a normal part of the immune system, with C4-V3 may make the vaccine more effective.   "
165092|NCT00005780|"     This study will evaluate the safety and effectiveness of an experimental cancer vaccine for     mantle cell lymphoma a form of cancer of the white blood cells called lymphocytes. Although     standard treatments for lymphoma may achieve disease remission, none provides a cure.      Patients with mantle cell lymphoma 18 years and older who have not been treated previously     with chemotherapy may participate in this study. Candidates will be screened for eligibility     with a medical history and physical examination. Other tests that may be required include     blood and urine tests; lung function studies; imaging tests such as magnetic resonance     imaging, computed tomography and X-rays; and biopsy (surgical removal of a small tissue     sample) of tumor, bone marrow, or other tissue.      Patients enrolled in the study will begin treatment with chemotherapy designed to reduce     disease to a minimum that is, to achieve remission or shrink the tumor as much as possible.     Chemotherapy will be administered on an outpatient basis over a period of around 12 to 18     weeks in 3-week cycles as follows: prednisone by mouth on days 1 through 5; etoposide,     doxorubicin and vincristine intravenously through (a vein) on days 1 through 5; and     cyclophosphamide intravenously on day 5. Starting day 6, patients receive no chemotherapy for     16 days. In addition, an antibody called rituximab, which attaches to lymphoma cells and may     increase the effectiveness of the chemotherapy, will be given on day 1 of the cycle. Patients     will also receive a protein called G-CSF starting day 6 of the cycle and continuing until the     white blood cell count recovers or until day 19. G-CSF is naturally produced by bone marrow     and may boost the immune system. The chemotherapy drugs and rituximab are infused through a     vein by means of a lightweight portable pump, which patients are taught how to use. Patients     are also how taught how to give themselves G-CSF injections under the skin, similar to     insulin injections.      The first vaccination will be given at least 3 months after chemotherapy ends and will be     repeated every 4 weeks for a maximum of 5 vaccinations. The vaccinations will be given in the     clinic. Patients will also receive daily injections of GM-CSF, a growth factor naturally     produced by bone marrow that can boost the immune system. These injections will be given the     day of the vaccination and for the next 3 days.      When vaccine therapy is completed, patients who were treated successfully will be followed     with periodic clinic visits for follow-up examinations and tests. Patients in whom the     lymphoma did not disappear entirely or who have a recurrence of disease will be advised of     further treatment possibilities.   "
165093|NCT00005781|"     This study will evaluate whether digital photography is a reliable tool for diagnosing hand     rashes, psoriasis and unusual moles. The findings will help determine if this method can be     used in the National Health and Nutrition Examination survey (NHANES), which monitors disease     in the United States.      Employees of the National Institutes of Health 19 years and older may enroll in this study.     Participants will complete a brief questionnaire that includes information on skin type,     history of skin conditions (moles, cancer, rashes, psoriasis), and demographic information     such as name, age and sex. They will be examined by a dermatologist, who will note in writing     the appearance of any hand rashes, unusual moles, or psoriasis. If any areas suspicious for     skin cancer are found, the participant will receive this information in writing, along with     advice about where to go for treatment.      A total of six photographs will then be taken of the participant's arms, legs, hands and     back. The face will not be photographed, and the participants will not be identifiable.   "
165094|NCT00005782|"     This study will examine the effects of granulocyte colony-stimulating factor (G-CSF) on bone     marrow stem cells in healthy volunteers with sickle cell trait and determine if cells     collected for transplantation from donors with sickle cell trait require special handling.      Stem cells, which the bone marrow produces, are responsible for making all the different     kinds of blood cells. They are the cells used in bone marrow, or stem cell, transplantation.     The drug G-CSF, which is a naturally occurring hormone, causes stem cells to mobilize-that     is, to be released from the bone marrow and enter the blood stream. This drug is given to     stem cell donors to increase the amount of cells that can be collected. Stem cell donors for     patients with sickle cell disease are often healthy siblings of the patient who have a     matching bone marrow type. Some siblings carry the sickle cell trait, however, and, even     though they do not have sickle cell disease and their blood and bone marrow are normal, it is     not known how their cells will react to G-CSF stimulation. Nor is it known if their stem     cells require special methods of removal, processing or storing.      Healthy volunteers 18 years or older with sickle cell trait who have no history of sickle     cell disease and no known medical problems may be eligible for this study. Participants will     have a medical history and physical examination, including blood tests and urinalysis. They     will receive injections of G-CSF under the skin once a day for 5 days. On the fifth day, stem     cells will be collected through leukapheresis. In this procedure, whole blood is drawn from     an arm vein, similar to donating whole blood. The blood then circulates through a cell     separator machine, the stem cells are removed, and the rest of the blood is transfused back     to the donor through a vein in the other arm.      The information gained from this study will be used to ensure the safety of stem cell donors     with sickle cell trait and to better prepare stem cells for transplantation in sickle cell     patients.   "
165104|NCT00005793|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating     patients who have previously untreated acute myeloid leukemia.   "
165105|NCT00005794|"     RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor.      PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have     advanced solid tumors.   "
165095|NCT00005783|"     Sickle cell anemia is a genetic disorder that results from a single nucleotide substitution     in codon 6 of the beta-globin gene which, in the homozygous state, produces an abnormal     hemoglobin that is prone to polymer formation when deoxygenated. The polymerized hemoglobin     leads to impaired deformability and sickling of red blood cells which subsequently lodge in     end-arterioles producing the classic and most prominent feature of the disorder, repeated     vasoocclusive crises. Despite knowledge of the precise genetic defect for decades, only     recently has there been therapeutic impact based upon this knowledge when a clear benefit     from treatment with hydroxyurea, a cell cycle-specific agent administered to induce     production of fetal hemoglobin (HbF) by stimulating gamma-globin synthesis, was reported in     patients with sickle cell disease (SCD). The reduction in the frequency and severity of     vasoocclusive crises seen has been attributed to the increase in HbF levels in responsive     patients. While the majority of patients demonstrate a rise in HbF, not all such patients     benefit from treatment. Given these results, alternative agents that also stimulate the     production of HbF warrant investigation in the treatment of SCD. Recombinant-methionyl human     stem cell factor (SCF) is a hematopoietic growth factor with activity on immature     hematopoietic progenitor cells. SCF stimulates the production of HbF in vitro and in vivo,     and this effect is attainable without the myelosuppression associated with hydroxyurea. In     this phase I/II trial, we will administer SCF in a dose escalating fashion to patients with     sickling disorders. Parameters to be measured are HbF levels, F cell levels, peripheral blood     CD34 levels, frequency, duration, and severity of vasoocclusive crises, and toxicity.   "
165096|NCT00005784|"     This study offers evaluation and treatment for patients with certain diseases of the retina     (the layer of light-sensitive tissue that lines the inside of the eyeball). The protocol is     not designed to test new treatments; rather, patients will receive the current standard of     care for his or her specific condition. The purpose of the study is twofold: 1) to allow     National Eye Institute physicians to increase their knowledge of retinal eye diseases and     identify possible new avenues of research in this area; and 2) to establish a pool of     patients who may be eligible for new studies as they are developed. (Participants in this     protocol will not be required to join a new study; the decision will be voluntary.)      Patients with diabetic retinopathy, age-related macular degeneration, vascular occlusive     disease, central serous retinopathy or another retinal disease may be eligible for this     study. Candidates will be screened with a medical history, brief physical examination,     thorough eye examination and blood test. The eye examination includes measurements of eye     pressure and visual acuity (ability to see the vision chart), examination of the pupils and     eye movements, and dilation of the pupils to examine the lens and retina. Patients will also     undergo fundus photography and fluorescein angiography, as follows:        -  Fundus photography - Special photographs of the inside of the eye to help evaluate the          status of the retina and evaluate changes that may occur in the future. From 2 to 20          pictures may be taken, depending on the eye condition. The camera flashes a bright light          into the eye for each picture.        -  Fluorescein angiography - Procedure to evaluate the eye's blood vessels. A yellow dye          injected into an arm vein travels to the blood vessels in the eyes. Pictures of the          retina are taken using a camera that flashes a blue light into the eye. The pictures          show if any dye has leaked from the vessels into the retina, indicating possible blood          vessel abnormality.      Participants will be followed at least 3 years. Follow-up visits are scheduled according to     the standard of care for the individual patient's eye problem. It is estimated that most     patients will have from one to four follow-up visits each year. Vision will be checked at     each visit, and some of the screening tests described above may be repeated to follow the     progress of disease and evaluate the response to treatment.   "
165097|NCT00005785|"     This study will investigate the safety and effectiveness of a new stem cell transplant     procedure to treat acute or chronic leukemia, multiple myeloma, myelodysplastic syndrome,     Hodgkin's and non-Hodgkin's lymphoma in HIV-infected patients.      HIV-infected patients usually are not offered bone marrow transplant treatments because they     are at increased risk of dying from the intense chemotherapy and radiation therapy used for     the procedure. This study uses a modified procedure, transplanting stem cells instead of bone     marrow, designed to be less dangerous for such patients. Patients will also undergo a     procedure called gene transfer to try to halt progression of their HIV infection. The     procedure in this study differs from standard bone marrow transplantation in three ways:      Stem cells will be transplanted instead of bone marrow. (Stem cells, which are produced by     the bone marrow, mature into the different blood components-white and red cells and     platelets.) The stem cell donor will be given a drug that releases these cells from their     bone marrow into the blood stream. The cells will then be collected from the donor by     apheresis, a procedure in which whole blood is drawn, the stem cells separated and removed,     and the rest of the blood returned to the donor.);      The procedure will use lower doses of chemotherapy than the conventional method, and will not     use radiation therapy; or      A laboratory-manufactured gene designed to obstruct HIV reproduction will be inserted into     the stem cells, rendering future cells that develop from resistance to the virus.      Prospective patients will be tested for matching with an HIV-negative donor (family member)     and will undergo a medical history, physical examination and several tests (e.g., breathing     tests, X-rays, etc.) to determine eligibility for the study. Study participants will then     undergo apheresis to collect white blood cells called lymphocytes. Stem cells will be     collected from the donor. Half the donated cells will have the HIV-resistant gene inserted;     the other half will have a control gene inserted. Additional stem cells collected a second     day will not be manipulated. All the donor cells will be frozen until transplantation.      Patients will be given drugs (cyclophosphamide, fludarabine and cyclosporin) to prevent the     donated cells from being rejected and to prevent them from damaging the patient's organs. The     thawed stem cells will then be infused through a vein. After 30, 60 and 100 days, bone marrow     cells and circulating lymphocytes will be checked to see how many are of donor cell origin.     If less than 100 percent are of donor origin, more lymphocytes will be transfused. Patients     will have physical examinations and blood tests once or twice a week for 2 to 3 months with     and then will be followed periodically for at least 5 years.   "
165098|NCT00005786|"     Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have     relapsed or refractory lymphoma or leukemia. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die   "
165099|NCT00005787|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy used to kill cancer cells. Treating the peripheral stem cells in     the laboratory may improve the effectiveness of the transplant.      PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in     patients who have relapsed or refractory non-Hodgkin's lymphoma and who will be treated with     high-dose chemotherapy.   "
165100|NCT00005788|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill lymphoma cells.      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who     have mycosis fungoides or Sezary syndrome.   "
165101|NCT00005790|"     RATIONALE: Perfusion magnetic resonance imaging may be an effective method of measuring the     growth of blood vessels in brain tumors. These measurements may help doctors better diagnose     and treat brain tumors.      PURPOSE: Pilot study to determine the effectiveness of perfusion magnetic resonance imaging     in measuring the growth of blood vessels in newly diagnosed brain tumors.   "
165102|NCT00005791|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating     patients who have locally advanced or metastatic solid tumors.   "
165103|NCT00005792|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus     peripheral stem cell transplantation in treating patients who have multiple myeloma.   "
165107|NCT00005796|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Inserting a     specific gene into a person's peripheral stem cells may improve the body's ability to fight     cancer or make the cancer more sensitive to chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus gene     therapy in treating patients who have CNS tumors.   "
165108|NCT00005797|"     RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor bone marrow     transplant helps stop the growth of cancer cells. It also helps stop the patient's immune     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are     infused into the patient they may help the patient's bone marrow make stem cells, red blood     cells, white blood cells, and platelets.      PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in     treating patients with hematologic cancers.   "
165109|NCT00005798|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     peripheral stem cell transplantation in treating women who have breast cancer.   "
165110|NCT00005799|"     This clinical trial studies fludarabine phosphate, low-dose total body irradiation, and donor     stem cell transplant in treating patients with hematologic malignancies or kidney cancer.     Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a     donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may     also stop the patient's immune system from rejecting the donor's stem cells. The donated stem     cells may replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte     infusion) after the transplant may help increase this effect. Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     cyclosporine before the transplant and cyclosporine and mycophenolate mofetil after the     transplant may stop this from happening.   "
165111|NCT00005800|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel in treating     women who have stage III breast cancer.   "
165112|NCT00005801|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem     cell transplantation may be able to replace immune cells that were destroyed by radiation     therapy used to kill tumor cells. Infusions of donor white blood cells may decrease the     body's rejection of the transplanted peripheral stem cells.      PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy, peripheral     stem cell transplantation, and donor white blood cell infusions in treating older patients     who have acute myeloid leukemia.   "
165113|NCT00005802|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill     leukemia cells. Treating donor white blood cells with interleukin-2 in the laboratory may     help them kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-2     when given after chemotherapy and donor white blood cells and to see how well they work in     treating patients with acute myeloid leukemia or acute lymphoid leukemia.   "
165114|NCT00005803|"     This phase I/II trial studies how well autologous stem cell transplant followed by donor stem     cell transplant works in treating patients with lymphoma that has returned or does not     respond to treatment. Peripheral blood stem cell transplant using stem cells from the patient     or a donor may be able to replace immune cells that were destroyed by chemotherapy used to     kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells     (graft-versus-tumor effect).   "
165115|NCT00005804|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give     higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating     patients who have hematologic cancer.   "
165116|NCT00005805|"     RATIONALE: Giving St. John's wort may be effective in relieving fatigue in patients with     cancer who are undergoing chemotherapy or hormone therapy.      PURPOSE: Randomized phase III trial to determine the effectiveness of St. John's wort in     relieving fatigue in patients who are undergoing chemotherapy or hormone therapy for cancer.   "
165117|NCT00005806|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating     patients who have advanced non-small cell lung cancer.   "
165118|NCT00005807|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have     metastatic, recurrent, or locally advanced, ovarian cancer, breast cancer, or metastatic or     unresectable solid tumors.   "
165119|NCT00005808|"     Phase I trial to study the effectiveness of photodynamic therapy with lutetium texaphyrin in     treating patients who have cervical intraepithelial neoplasia. Photodynamic therapy uses     light and drugs such as lutetium texaphyrin that make abnormal cells more sensitive to light     and may kill abnormal cells in the cervix and prevent the development of cervical cancer   "
165120|NCT00005809|"     RATIONALE: New diagnostic procedures such as computed tomographic colonography may provide a     less invasive method of identifying patients who have colorectal neoplasia.      PURPOSE: Diagnostic study to compare the effectiveness of computerized tomographic     colonography with that of standard diagnostic procedures in detecting colorectal neoplasia.   "
165156|NCT00005845|"     This phase I trial studies the side effects and best dose of tipifarnib in treating patients     with myelodysplastic syndromes. Tipifarnib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth.   "
165121|NCT00005810|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     filgrastim in treating patients who have stage IV prostate cancer that has not responded to     hormone therapy.   "
165122|NCT00005811|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. This phase II trial is studying how well topotecan hydrochloride works in     treating children with meningeal cancer that has not responded to previous treatment   "
165123|NCT00005812|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who     have leptomeningeal metastases from a solid tumor or lymphoma.   "
165124|NCT00005813|"     RATIONALE: Bispecific antibodies plus white blood cells may be able to locate tumor cells and     either kill them or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of combining bispecific antibodies with     white blood cells in treating patients who have recurrent or refractory glioblastoma     multiforme.   "
165125|NCT00005814|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy     with monoclonal antibody therapy and radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining cetuximab, cisplatin, and     radiation therapy in treating patients who have advanced stage III or stage IV head and neck     cancer.   "
165126|NCT00005815|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Thalidomide may stop the growth of melanoma by stopping blood flow     to the tumor. Combining chemotherapy with thalidomide may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness temozolomide plus thalidomide in     treating patients who have stage III or stage IV melanoma that cannot be removed during     surgery.   "
165127|NCT00005816|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have stage III or stage IV kidney cancer.   "
165128|NCT00005817|"     Randomized phase II trial to compare the effectiveness of two regimens of rebeccamycin     analogue in treating women who have stage IIIB or stage IV breast cancer. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. The best way to give rebeccamycin analog in breast cancer patients is not yet known   "
165129|NCT00005818|"     Phase I/II trial to study the effectiveness of combining SU5416 and irinotecan in treating     patients who have advanced colorectal cancer. SU5416 may stop the growth of colorectal cancer     by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die   "
165130|NCT00005819|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of combination     chemotherapy in treating patients with advanced solid tumors.   "
165131|NCT00005820|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating men who     have stage IV prostate cancer that has not responded to hormone therapy.   "
165132|NCT00005821|"     RATIONALE: Diagnostic procedures such as sentinel lymph node biopsy may improve the ability     to detect breast cancer and determine the extent of disease.      PURPOSE: Phase II trial to study the effectiveness of sentinel lymph node biopsy to assess     axillary lymph nodes in women who have stage I or stage II breast cancer.   "
165133|NCT00005822|"     RATIONALE: SU5416 may stop the growth of breast cancer by stopping blood flow to the tumor.     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of combining SU5416 and doxorubicin in     treating patients who have stage IIIB or stage IV inflammatory breast cancer.   "
165134|NCT00005823|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. It is not yet known if stronger doses of chemotherapy given over     a longer period of time are as well tolerated or as effective as less intensive chemotherapy.      PURPOSE: This randomized phase III trial is studying intensive regimens of chemotherapy to     see how well they work compared to nonintensive regimens of chemotherapy in treating older     patients with acute myeloid leukemia or myelodysplastic syndrome.   "
165135|NCT00005824|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to     give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral     stem cell transplantation in treating patients who have recurrent or refractory AIDS-related     lymphoma.   "
165136|NCT00005825|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have stage IIIB or stage IV non-small cell lung cancer.   "
165137|NCT00005826|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients     who have glioblastoma multiforme.   "
165138|NCT00005827|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase I trial to determine the effectiveness of genistein in treating     patients who have stage II, stage III, or stage IV prostate cancer.   "
165139|NCT00005828|"     RATIONALE: Green tea extract contains substances that may slow the growth of certain cancers     and may prevent the development of new cancers.      PURPOSE: Phase II trial to determine the effectiveness of green tea extract in treating     patients who have metastatic prostate cancer that has not responded to hormone therapy.   "
165140|NCT00005829|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who     have recurrent chronic lymphocytic leukemia.   "
165141|NCT00005830|"     Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy     in treating women who have stage III or stage IV endometrial cancer. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy     with radiation therapy may kill more tumor cells.   "
165142|NCT00005831|"     Phase II trial to study the effectiveness of combining trastuzumab with combination     chemotherapy in treating patients who have locally recurrent or metastatic urinary tract     cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them     or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor     cells   "
165143|NCT00005832|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have     locally advanced or metastatic pancreatic cancer.   "
165144|NCT00005833|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have     recurrent or advanced colorectal cancer.   "
165145|NCT00005834|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Thalidomide may stop the growth of tumor cells by stopping blood     flow to the tumor. It is not yet known if combination chemotherapy is more effective with or     without thalidomide for multiple myeloma.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without thalidomide in treating patients who have refractory multiple myeloma.   "
165146|NCT00005835|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase I trial to study the effectiveness of melphalan and buthionine sulfoximine     followed by bone marrow or peripheral stem cell transplantation in treating children who have     resistant or recurrent neuroblastoma.   "
165147|NCT00005836|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who     have recurrent or refractory ovarian epithelial cancer or primary peritoneal cancer that has     not responded to platinum-based chemotherapy.   "
165148|NCT00005837|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who     have recurrent or refractory cervical cancer.   "
165149|NCT00005838|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy     uses high-energy x-rays to damage tumor cells. AE-941 may help shrink or slow the growth of     non-small cell lung cancer cells. It is not yet known if combination chemotherapy plus     radiation therapy is more effective with or without AE-941 for non-small cell lung cancer.     This randomized phase III trial is studying combination chemotherapy and radiation therapy     given with AE-941 to see how well they work compared to combination chemotherapy and     radiation therapy alone in treating patients with stage III non-small cell lung cancer that     cannot be removed by surgery   "
165150|NCT00005839|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin combined with capecitabine     in treating patients who have metastatic or recurrent solid tumors.   "
165151|NCT00005840|"     This phase I trial is studying the side effects and best dose of combination chemotherapy     when given with radiation therapy in treating patients with stage III or stage IV endometrial     cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.   "
165152|NCT00005841|"     RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to     kill tumor cells. Vaccine therapy plus filgrastim combined with a specific protein may be a     more effective treatment for melanoma.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with stage III or stage IV melanoma that has been completely removed during     surgery.   "
165153|NCT00005842|"     Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who     have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate     tumor cells and either kill them or deliver tumor-killing substances to them without harming     normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing     so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.   "
165154|NCT00005843|"     Phase II trial to study the effectiveness of R115777 in treating patients who have metastatic     pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die.   "
165155|NCT00005844|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating children who     have advanced solid tumors.   "
203316|NCT00508950|"     The study will identify healthy adults who have been vaccinated against pneumococcus, and     collect blood for the purpose of developing laboratory assays.   "
165157|NCT00005846|"     RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary     for cancer cell growth.      PURPOSE: This phase I/II trial is studying the side effects of tipifarnib and to see how well     it works in treating patents with myeloproliferative disorders.   "
165158|NCT00005847|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Biological     therapies use different ways to stimulate the immune system and stop cancer cells from     growing. It is not yet known which treatment regimen is more effective in treating metastatic     prostate cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy     with that of chemotherapy plus biological therapy in treating patients who have progressive     or metastatic prostate cancer that has not responded to hormone therapy.   "
165159|NCT00005848|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have     progressive, metastatic prostate cancer that has not responded to hormone therapy.   "
165160|NCT00005849|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 plus paclitaxel in     treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.   "
165161|NCT00005850|"     This trial is designed to test the efficacy of fluoxetine to improve patient's quality of     life during chemotherapy. An innovative application of a selective serotonin reuptake     inhibitor may modulate the effects of fatigue, anxiety and depression which worsen quality of     life.   "
165162|NCT00005851|"     The reason for doing this study is to see if cancer will respond to immune therapy after     transplantation of blood stem cells (from the bone marrow) using a new kind of treatment     regimen that is less toxic than that previously used for blood stem cell transplants. This     type of transplant uses much less chemotherapy and radiation than standard bone marrow     transplants. The treatment consists of medications that weaken the immune system so it     doesn't reject the donor's marrow cells. Researchers hope that the immune cells from the     donor will attack the tumor. This is called a graft versus tumor effect and has been seen     in other types of cancer. In addition, 65 days or more after the transplant the patient may     be eligible for an immune treatment that uses additional immune cells from the donor to     increase the effect of the stem cells against the cancer.   "
165163|NCT00005852|"     RATIONALE: Bone marrow from donors may be able to treat patients with severe aplastic anemia     and patients whose bodies have rejected previous bone marrow transplantation.      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating     patients who have severe aplastic anemia or whose bodies have rejected previous bone marrow     transplant.   "
165164|NCT00005853|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Combining different types of biological therapies may kill more     cancer cells.      PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients     who have myelodysplastic syndrome.   "
165165|NCT00005854|"     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were     destroyed by chemotherapy and radiation therapy used to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating     patients who have hematologic cancer.   "
165166|NCT00005855|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of efaproxiral when     given with carmustine and to see how well they work in treating patients with progressive or     recurrent malignant glioma.   "
165167|NCT00005856|"     This phase I/II trial is studying the side effects and best dose of oxaliplatin in treating     patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing   "
165168|NCT00005857|"     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to compare the effectiveness of trastuzumab alone and in combination     with docetaxel in treating patients who have metastatic prostate cancer that is refractory to     hormone therapy.   "
165169|NCT00005858|"     Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have     advanced colon, breast, non-small cell lung, bladder, pancreatic, or ovarian cancer. The     LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells.   "
165170|NCT00005859|"     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary     for tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who     have recurrent or progressive malignant glioma.   "
165171|NCT00005860|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin with or without floxuridine     and leucovorin in treating patients who have metastatic cancer of the peritoneum.   "
165172|NCT00005861|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating women     who have recurrent, stage III, or stage IV endometrial cancer.   "
165173|NCT00005862|"     Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced,     metastatic, or recurrent soft tissue sarcomas. SU5416 may stop the growth of soft tissue     sarcomas by stopping blood flow to the tumor.   "
165250|NCT00005950|"     Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent     or refractory non-Hodgkin's lymphoma or T-cell lymphoma. Drugs used in chemotherapy use     different ways to stop cancer cells from dividing so they stop growing or die   "
165174|NCT00005863|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy. It is not yet known whether     combination chemotherapy with filgrastim and/or tretinoin is more effective than combination     chemotherapy alone for acute myeloid leukemia.      PURPOSE: This randomized phase III trial is studying combination chemotherapy with filgrastim     and/or tretinoin to see how well they work compared to combination chemotherapy alone in     treating patients with acute myeloid leukemia.   "
165175|NCT00005864|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of chloroquinoxaline sulfonamide in     treating patients who have stage IV colorectal cancer.   "
165176|NCT00005865|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving drugs in different ways may kill more tumor cells. It is not     yet known whether giving vinorelbine by mouth or infusion is more effective in treating non-     small cell lung cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of vinorelbine given by mouth     or as an infusion in treating patients who have stage IIIB or stage IV non-small cell lung     cancer.   "
165177|NCT00005866|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known     if total-body irradiation plus peripheral stem cell transplantation is more effective with     busulfan or with cyclophosphamide for myelodysplastic syndrome or acute myeloid leukemia.      PURPOSE: Randomized phase III trial to compare the effectiveness of busulfan with that of     cyclophosphamide in patients undergoing total-body irradiation plus peripheral stem cell     transplantation for advanced myelodysplastic syndrome or related acute myeloid leukemia.   "
165178|NCT00005867|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. It is not yet known which regimen of combination chemotherapy is     most effective for non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy     and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.   "
165179|NCT00005868|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of docetaxel and cisplatin in treating     patients who have untreated stage IIIA non-small cell lung cancer.   "
165180|NCT00005869|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether nitrocamptothecin is more effective     than gemcitabine for pancreatic cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with     gemcitabine in treating patients who have unresectable locally advanced or metastatic     pancreatic cancer.   "
165181|NCT00005870|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether nitrocamptothecin is more effective     than other chemotherapy for cancer of the pancreas.      PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with     that of other chemotherapy in treating patients who have recurrent or refractory cancer of     the pancreas.   "
165182|NCT00005871|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether nitrocamptothecin is more effective     than fluorouracil for pancreatic cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with     that of fluorouracil in treating patients who have recurrent or refractory pancreatic cancer     and who have been treated previously with gemcitabine.   "
165183|NCT00005872|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients     who have recurrent non-small cell lung cancer.   "
165184|NCT00005873|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients     who have locally recurrent or metastatic breast cancer.   "
165185|NCT00005874|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients     who have locally advanced or metastatic soft tissue sarcomas.   "
165186|NCT00005875|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients     who have metastatic melanoma.   "
165187|NCT00005876|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients     who have locally advanced or metastatic stomach cancer that cannot be removed during surgery.   "
165188|NCT00005877|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients     who have advanced or recurrent colorectal cancer.   "
165189|NCT00005878|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Celecoxib may be effective in preventing cancer in     patients with Barrett's esophagus.      PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing     cancer in patients who have Barrett's esophagus.   "
165190|NCT00005879|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of LY353381 may be an effective way to prevent     the development of breast cancer in women who have hyperplasia.      PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing     breast cancer in women who have hyperplasia.   "
165191|NCT00005880|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of budesonide may be an effective way to prevent     bronchial dysplasia.      PURPOSE: Randomized double-blinded phase II trial to determine the effectiveness of     budesonide in treating former or current smokers who have bronchial dysplasia.   "
165192|NCT00005881|"     RATIONALE: Questionnaires that measure quality of life may improve the ability to plan     treatment for children with cancer.      PURPOSE: This randomized clinical trial is studying the quality of life in children treated     for cancer.   "
165193|NCT00005883|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Phenethyl isothiocyanate may be effective in preventing     lung cancer in smokers.      PURPOSE: Phase I trial of phenethyl isothiocyanate in preventing lung cancer in people who     smoke.   "
165194|NCT00005884|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of eflornithine may be an effective way to     prevent the recurrence of or further development of skin cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of eflornithine in     preventing skin cancer in patients who have previously received treatment for early stage     skin cancer.   "
165195|NCT00005886|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen.      PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers     of the tumor tissue, compared with LY353381, in treating women with newly diagnosed breast     cancer.   "
165196|NCT00005887|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     RSR13 may make tumor cells more sensitive to radiation therapy.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the     brain with or without RSR13 in treating patients who have brain metastases.   "
165197|NCT00005888|"     OBJECTIVES: I. Compare the incidence of late onset sepsis and/or necrotizing enterocolitis     and duration of hospitalization in low birth weight infants fed with fortified mother's milk     supplemented with either fortified pasteurized donor human milk or preterm formula, and with     fortified mother's milk versus preterm formula.      II. Determine the relationship between functional antibody titers in serial milk samples and     the incidence of pathogen specific late onset sepsis (e.g., Staphylococcus epidermidis,     Staphylococcus aureus) in these patients.      III. Determine the long term sequelae (growth, body composition, health, and     neurodevelopment) of human milk versus formula feeding in these patients.      IV. Determine the relationship between stress and milk production in the mothers of these     patients.   "
165198|NCT00005889|"     RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels.     Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of     amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar     levels is not yet known.      PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids,     fat, and sugar given by intravenous infusion, and the effect of different combinations of     nutrients on the infants' ability to maintain normal blood sugar levels.   "
165199|NCT00005890|"     OBJECTIVES:      I. Examine adrenal cortical function and the incidence of adrenal dysfunction in children     with septic shock.      II. Examine the mortality, length of stay in the PICU, and incidence of multiorgan failure in     children with adrenal dysfunction and septic shock.   "
165200|NCT00005891|"     OBJECTIVES:      I. Determine the effectiveness of moderate dose cyclophosphamide and total lymphoid     radiotherapy in terms of improving the survival and reducing the morbidity following     allogeneic bone marrow transplantation in patients with Fanconi's aplastic anemia.   "
165201|NCT00005892|"     OBJECTIVES:      I. Determine the effectiveness of moderate dose cyclophosphamide and radiotherapy in terms of     improving survival and reducing the morbidity following allogeneic bone marrow     transplantation in patients with myelodysplastic syndrome and acute leukemia related to     Fanconi's anemia.   "
165202|NCT00005893|"     OBJECTIVES: I. Determine the efficacy of bone marrow transplantation using matched related     donors in patients with nonmalignant hematologic disorders.      II. Determine the quality of life, absence of adverse effects (e.g., graft versus host     disease and B cell lymphoproliferative disease), and completeness of recovery of their     underlying condition in these patients with this treatment regimen.   "
165203|NCT00005896|"     OBJECTIVES: I. Determine the safety of transferring the Fanconi anemia complementation group     C (FACC) gene to hematopoietic progenitors by retroviral mediated gene transfer in patients     with Fanconi's anemia, complementation group C.      II. Determine the extent of engraftment following this treatment regimen without prior     ablation of recipient marrow in these patients.      III. Determine the ability of this treatment regimen to correct the cell phenotype and     improve hematopoietic function in these patients.   "
165204|NCT00005898|"     OBJECTIVES: I. Determine the probability of engraftment with total body irradiation,     cyclophosphamide, fludarabine, and anti-thymocyte globulin followed by HLA nongenotypically     identical donor, T-cell depleted hematopoietic cell transplantation in patients with     Fanconi's anemia.      II. Determine the incidence of acute and chronic graft-versus-host disease in these patients     after undergoing this treatment regimen.      III. Determine the one-year survival rate in these patients after undergoing this treatment     regimen.      IV. Determine the toxicity of this treatment regimen in these patients. V. Determine the     incidence of relapse in patients with myelodysplastic syndrome or acute myeloid leukemia     after undergoing this treatment regimen.   "
165205|NCT00005900|"     OBJECTIVES: I. Evaluate bronchoalveolar lavage fluid and serum obtained from pediatric     patients with storage disorders prior to allogeneic hematopoietic stem cell transplantation     (HSCT) for the presence of proinflammatory cytokines and for the production of nitric oxide     by alveolar macrophages to identify possible risk factors for pulmonary complications.      II. Investigate the underlying mechanism for the development of significant pulmonary     complications in these patients during HSCT.      III. Evaluate bronchoalveolar lavage fluid and serum obtained from these same patients at the     time a pulmonary complication develops post-HSCT, or at 60 days post-HSCT if there has been     no pulmonary complications.   "
165206|NCT00005901|"     This study will evaluate the effect of pamidronate a drug that decreases bone resorption     (breakdown) on osteogenesis imperfecta. This is a genetic disorder of collagen, the major     protein in bone. The abnormal collagen causes weak bones, and children with severe     osteogenesis imperfecta sustain many fractures throughout their lives. They also have growth     deficiency, curvature of the spine, crumbling teeth, hearing loss, easy bruising and heart     and lung problems. The study will compare bone density, quality and strength, final adult     height, trunk height, and functional ability in children who receive 1) pamidronate every 3     months, 2) pamidronate every 3 months + growth hormone injections, 3) pamidronate every 6     months, or 4) pamidronate every 6 months + growth hormone injections.      Children 2 years of age and older with severe osteogenesis imperfecta (types III and IV) may     be eligible for this study. Those enrolled will be randomly assigned to groups according to     age; children two to four years of age will be randomly assigned to receive pamidronate every     3 or every 6 months. Children four years of age and older may participate in the growth     hormone treatment groups. These children will continue on growth hormone until they reach     their adult height or fail to grow as much as would be expected for someone on growth     hormone.      Patients will be followed in the clinic every 3 months for a history, physical examination,     X-rays, blood tests, and measurements (weight, head circumference, and bone lengths).     Children will receive a 3 to 4 hour infusion of pamidronate through an intravenous catheter     (thin flexible tube placed in a vein) once a day for 3 days each visit. (Once inserted, the     catheter is left in place to avoid multiple needle sticks for administering the drug and     collecting blood samples.) Children who are taking growth hormone will be given the drug at     the first treatment visit. At that time, the accompanying parent will be instructed on how to     mix the drug and give injections. The child receives an injection 6 days a week (Sunday off).   "
165207|NCT00005902|"     The purpose of this study is to learn more about the growth of brain and spinal cord tumors     and cysts that develop in association with them in patients with von Hippel-Lindau disease.     It will examine how fast the tumors grow and try to determine what factors (for example,     puberty , pregnancy, menopause, blood proteins, etc.) affect their growth.      Patients between the ages of 8 and 75 years who are enrolled in NIH s study of von     Hippel-Lindau disease may be eligible for this 5-year study. Participants will have magnetic     resonance imaging (MRI) of the brain and spinal cord and a thorough neurological history and     examination at the start of the study. A blood sample will be taken for analysis of factors     (hormones or other proteins) that may predict tumor growth. Follow-up clinic visits every 6     months will include a physical and neurological examination, blood tests, and MRI scans of     the brain and spine. If symptoms or tumor growth requires more frequent follow-up, scans will     be done at 3-month intervals.      Surgical removal of brain and spinal cord tumors is currently the treatment of choice when     these lesions cause neurological problems. A better understanding of which tumors are likely     to grow and which will remain stable may help guide physicians in treatment decisions and     avoid unnecessary procedures.   "
165208|NCT00005903|"     This study will examine the safety and effectiveness of an experimental drug called GDNF     delivered through an investigational device to treat progressive supranuclear palsy (PSP).     The drug will be administered directly into the brain through catheters attached to an     infusion pump implanted in the abdomen. The study will evaluate 1) if the drug is safe and     well tolerated when given by this method; 2) the performance of the catheters and pump     system, and 3) the effects of GDNF on PSP symptoms.      PSP is a rare neurological disease that causes eye movement dysfunction, muscle rigidity,     slowness of movement, swallowing, speech, emotional, cognitive and personality problems.     Patients 35 to 75 years old with PSP may be eligible for this study. Candidates will be     screened at the National Institutes of Health outpatient clinic in Bethesda, MD, with a     medical history, physical examination, neurological and neuropsychiatric evaluations, blood     tests, electrocardiogram, CT scan of the brain, and baseline studies including a special eye     examination, evaluation of symptoms, lumbar puncture (spinal tap) and psychiatric interview.      Patients enrolled in the study will undergo surgery to place two catheters into the brain and     two infusion pumps under the skin in the upper abdomen. The surgery will be performed at     Vanderbilt University Medical Center in Nashville, TN. It will be done under general     anesthesia and will require a 3 day hospitalization. Within 24 hours after the surgery, a CT     scan of the brain will be done to ensure the catheters are properly placed. Patients return     to NIH two weeks after surgery for post-surgery examination and treatment initiation.      All patients will receive continuous infusions of GNDF through one catheter and placebo (an     inactive salt solution) through the other for 6 months. Half of the patients will receive     placebo in the right side of the brain and GNDF in the left, and half will receive GNDF in     the right side of the brain and placebo in the left. All patients will also undergo the     following procedures:      Brief physical examination, and evaluation of symptoms and adverse side effects - every 2     weeks      Blood and urine tests - every 2 weeks for the first 2 months and then every 8 weeks until the     end of the study      CT scan to check catheter placement - weeks 9 and 27      Thorough evaluation of symptoms - before beginning treatment and weeks 1, 5, 9, 17 and 27      Neuropsychiatric evaluation - week 27      Special eye examination - weeks 1 and 27      Lumbar puncture - week 27      Additional blood tests to measure drug concentration and antibodies - 6 times during the     study      In addition, some patients may be asked to have positron emission tomography (PET) scans or a     single photon emission tomography (SPECT) scan, or both.      The potential benefit of GDNF is unknown. In studies with rats and monkeys, GNDF increased     the number and size of brain cells containing the chemical messenger dopamine and some     movement and balance problems were lessened. Earlier studies of GDNF infused into the     ventricles of patients with Parkinson's disease showed no benefit and no serious harm.   "
165209|NCT00005905|"     This study will evaluate the safety and effectiveness of the leptin replacement therapy in     treating lipoatrophy or lipodystrophy-a condition in which there is a total or partial loss     of fat cells. Patients with lipodystrophy lack sufficient leptin, because this hormone is     produced by fat cells. The leptin deficiency usually causes high blood lipid (fat) levels and     insulin resistance that may lead to diabetes. Patients may have hormone imbalances, fertility     problems, uncontrolled appetite, and liver disease due to fat accumulation.      Patients 15 years and older with lipodystrophy are eligible for this study. Candidates are     screened with a medical history and physical examination, and fasting blood tests. Those     enrolled undergo the following additional procedures:        -  Ultrasound of the liver and, if abnormalities are found, possibly a liver biopsy        -  Resting metabolic rate measurement - measures the amount of oxygen breathed at rest in          order to calculate how many calories are required to maintain resting body functions        -  Magnetic resonance imaging of the liver and other organs, and of muscle and fat        -  Estimation of body fat - measurements of height, weight, hip size, and skin folds over          the arms and abdomen to estimate body fat content        -  Insulin tolerance test - measures blood glucose levels after administration of insulin.          Insulin is given through an intravenous (IV) catheter (a thin tube placed in a vein) and          blood is drawn 5 minutes before the test begins, when the test begins, and 5, 10, 15, 20          and 30 minutes into the test        -  Oral glucose tolerance test - measures blood glucose and insulin levels after drinking a          glucose (sugar) solution. Blood samples are drawn through an IV catheter 15 minutes          before the test begins, at the time the test begins, and 30, 60, 90 and 180 minutes into          the test        -  Intravenous glucose tolerance test - measures tissue response to insulin and glucose          after glucose is injected into a vein. The glucose injection is followed by a short          infusion of insulin and then blood samples are taken over 3 hours to measure insulin and          glucose levels        -  Appetite level and food intake - measures hunger level and caloric intake. Patients are          questioned about their hunger level, given a variety of foods they may choose to eat and          questioned again at various intervals about hunger level. On another day, patients are          given breakfast (usually a milkshake) and when they want to eat again, the appetite          level and caloric intake study is repeated.        -  Hormone function tests - the function of three hormones influenced by leptin          (corticotropin-releasing hormone, thyrotropin-releasing hormone and luteinizing          hormone-releasing hormone) are assessed. The hormones are injected intravenously and          then blood samples are drawn.      When all the tests are completed, leptin therapy begins. The drug is injected under the skin     twice a day for 4 months by the patient or a caregiver (similar to self-administered insulin     injections for diabetes). Blood is drawn once a month to monitor the effects of treatment and     drug side effects. At clinic visits scheduled 1, 2 and 4 months after therapy starts,     patients have a physical examination and meet with a dietitian. Medication dosage is also     increased at these visits. At the end of 4 months, all baseline studies described above are     repeated. Throughout the study, all patients complete a form once a week, in which they     record their symptoms. Patients with diabetes also measure their blood glucose levels at home     before each meal and at bedtime.   "
165210|NCT00005906|"     Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is     characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas). Within the     LAM patient population is a subset of patients who develop chylous effusions and     lymphangioleiomyomas. Treatment of many of these symptoms has been ineffective. Previous     studies with somatostatin and octreotide in other clinical settings have shown reduction in     chylous effusions. This study assesses the effectiveness of octreotide in symptomatic     patients with LAM, lymphangioleiomyomas and/or chylous effusions/ascites, peripheral     lymphedema and chyluria.   "
165211|NCT00005907|"     This study will compare the immune system response to booster vaccines for tetanus/diphtheria     and hepatitis B in healthy volunteers with that of patients who have had a blood transplant.     (A blood transplant is an infusion of donated stem cells-i.e., cells that mature into white     blood cells, red blood cells and platelets). The study will also look at how age of the blood     cell donor and recipient, the type of blood transplant, the amount of certain types of white     cells in donor blood, and other variables may influence the vaccine response among the     transplant patients.      This study includes normal volunteers and patients who have had a blood transplant. Healthy     volunteers between the ages of 18 and 60 who have previously been vaccinated with the     hepatitis B or tetanus/diphtheria vaccine and have not had hepatitis B may be eligible for     this study. Patients enrolled in a blood cell transplant study at NIH who are between 5 and     60 years old, have been vaccinated against tetanus/diphtheria, and have not had hepatitis B     may be eligible. Candidates will be screened with a medical history and blood tests.      Those enrolled in the study will have about 2 tablespoons of blood drawn before vaccination     with a standard tetanus/diphtheria booster shot. Volunteers who have previously been     vaccinated with the hepatitis B vaccine and all blood transplant patients will also receive a     hepatitis B vaccination. Participants will have blood drawn (from 1 to 5 tablespoons) up to     once a week after vaccination for no more than 8 weeks to evaluate the immune response to     vaccination.   "
165212|NCT00005908|"     This study will assess the usefulness of a technique called complementary deoxyribonucleic     acid (cDNA) microarray-an examination of a wide array of genes to identify disease-associated     patterns-for measuring tumor response to chemotherapy in breast cancer patients. The study     will look for markers that can help select the most effective type of chemotherapy. It will     also evaluate the safety and effectiveness of a new drug combination of capecitabine and     docetaxel.      Patients age 18 years and older with stage II or III breast cancer whose tumor is 2     centimeters or larger may be eligible for this study. Those enrolled will be treated with     surgery, standard chemotherapy using doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan),     and the capecitabine and docetaxel combination.      Patients will have a physical examination, mammogram and magnetic resonance imaging to     evaluate their tumor before beginning treatment. They will then have four 21-day treatment     cycles of docetaxel and capecitabine, as follows: docetaxel intravenously (through a vein) on     day 1 and capecitabine pills (by mouth) twice a day from days 2 through 15. No drugs will be     given from days 16 through 21. This regimen will be repeated four times, after which the     tumor will be re-evaluated by physical examination, mammogram, and magnetic resonance     imaging.      Patients will then have surgery to remove the cancer-either lumpectomy with removal of the     underarm lymph nodes; mastectomy and removal of the underarm lymph nodes; or modified radical     mastectomy. After recovery, they will have four more cycles of chemotherapy, this time with a     doxorubicin and cyclophosphamide. Both drugs will be given intravenously on day 1 of four     21-day cycles.      Some patients who had a mastectomy (depending on their tumor characteristics and whether     tumor cells were found in their lymph nodes) and all those who had a lumpectomy will also     have radiation therapy. Patients with hormone receptor-positive tumors will also receive     tamoxifen treatment for 5 years.      In addition to the above procedures, all patients will have tumor biopsies (removal of a     small piece of tumor tissue) before beginning treatment, on day 1 of cycle 1, before cycle 2,     and at the time of surgery, and physical examinations, chest X-rays, bone scans, computerized     tomography (CT) scans, electrocardiograms, multi-gated acquisition scan-MUGA (nuclear     medicine test of cardiac function) or echocardiograms of heart function, mammograms and blood     tests at various times during the study. Patients will be followed at National Institutes of     Health (NIH) for 3 years after diagnosis with physical examinations, blood tests, X-rays, and     computed tomography (CT) scans.      Although it is not known whether this treatment will help an individual patient's cancer,     possible benefits are tumor shrinkage and decreased risk of disease recurrence. In addition,     the information gained about genetic changes after chemotherapy will help determine if     additional studies on the use of cDNA microarray to measure tumor response are warranted.   "
165251|NCT00005951|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating     patients who have recurrent primary malignant glioma.   "
165213|NCT00005909|"     The purpose of this study is to gain a better understanding of alkaptonuria and collect     medical data on patients who may later participate in new drug trials for this rare genetic     disease. In alkaptonuria, a pigment called homogentisic acid collects in bone and connective     tissue, causing arthritis and eventually bone fractures, and also causes discoloration in the     ears and whites of the eyes. Some patients also develop kidney stones and heart valve     problems. Alkaptonuria has not been studied for decades; and scientists expect to gain     comprehensive clinical information using current medical techniques.      Patients with alkaptonuria who are at least one month old may be eligible for this study.     Participants will be evaluated at NIH s Clinical Center for 5 days every 2 to 3 years. They     will have a medical history, physical examination, routine blood and urine tests. Blood may     also be collected to measure a type of collagen that indicates new bone formation and to     analyze DNA for genetic studies. 24-hour urine collections will be done to measure organic     acids and homogentisic acid excretion, assess overall kidney function, and evaluate bone     metabolism. A total of 89.5 ml (about 6 tablespoons) of blood will be drawn for these studies     in adults and 51 ml (about 3 tablespoons) in children.      Patients will also have bone X-rays, kidney ultrasound, brain and chest computerized     tomography (CT) scans, magnetic resonance imaging (MRI) scans of affected joints,     electrocardiograms, echocardiogram, lung function tests, and a hearing test. Photographs of     the face and full body (with underwear on) will be taken.      Patients will also have consultations with dentistry and ophthalmology, with physical therapy     and rehabilitation medicine for arthritis management, and with cardiology for heart valve     evaluation. When appropriate, patients may also have dermatology, pulmonology and neurology     consultations.      The information from this study will enable doctors to better advise patients with     alkaptonuria about their disease and treatment options. It will also prepare the way for     clinical studies of a new drug that blocks production of homogentisic acid.   "
165214|NCT00005910|"     This study will determine if laparoscopy can be used successfully to find and remove     insulinomas (insulin-secreting tumors of the pancreas). These tumors are very small and often     difficult to locate with magnetic resonance imaging (MRI), computed tomography (CT) or     ultrasound. Invasive procedures, such as arteriograms (X-ray imaging using a contrast agent     injected into the bloodstream through a catheter) and venous sampling are more successful but     involve more patient discomfort and greater risk. This study will test whether laparoscopy     can be used to replace some or all of these tests, as well as more extensive surgery.      Patients 11 years of age and older with low blood sugar (hypoglycemia) probably caused by an     insulinoma may be eligible for this study. Candidates will have their hypoglycemia confirmed     (with tests done under NIH protocol 91-DK-0066: Diagnosis and Treatment of Hypoglycemia) and     will have CT imaging of the abdomen and MRI and ultrasound tests of the liver and pancreas.     Patients whose tumors are not found by these studies will undergo arteriography of the     pancreas and hepatic (liver) venous sampling.      Patients will then have laparoscopy. This surgical procedure uses a laparoscope-a tube-like     device with special cameras and an ultrasound probe attached through which the surgeon can     see and operate inside the abdomen. Laparoscopy is commonly done to remove the gallbladder     and is also used to remove portions of the pancreas. For the current procedure, the surgeon     makes small incisions in the abdomen, inserts tubes, fills the abdomen with gas, and proceeds     to explore and operate on the pancreas. The surgeon will try to locate the tumor with the     laparoscope. If the tumor is found, the location will be verified by the imaging study     results. If it cannot be located by laparoscopy, the results of the imaging studies will be     disclosed to enable removal. If the tumor cannot be successfully removed using the     laparoscope, standard surgery will then be performed. If the tumor cannot be found though     laparoscopy, imaging studies, or traditional surgery, the operation will be concluded without     removing any of the pancreas. Medical treatment will be initiated and re-evaluation will be     recommended after 6 months.   "
165215|NCT00005911|"     This study will assess the value of improved magnetic resonance imaging (MRI) techniques to     study the lens of the human eye. Knowledge of how cataracts develop and progress has been     hampered by the lack of human tissue available for study; MRI may provide an effective means     for learning more about this eye disease.      Normal volunteers between 18 and 70 years of age may be eligible for this study. Participants     will undergo a medical history and complete eye examination, including vision assessment, eye     pressure measurement, lens and retina examinations, and photography of the eye.      MRI scans will be scheduled for a second visit. For this procedure, the volunteer's pupils     are dilated and he or she then lies on a stretcher that is moved into a cylinder containing a     magnetic field. A device similar to a welder's helmet is placed on the head. Attached to the     device are an imaging probe and a small blinking light. The probe receives radio signals from     the eye that a computer converts into images. During imaging, the participant gazes at the     blinking light; this helps keep the eyes from blinking and wandering. Scan times vary from 2     to 10 minutes; the total time for the study is less than an hour.   "
165216|NCT00005912|"     This study will examine how children's bodies metabolize and eliminate the anti-fungal drug     voriconazole. The results will yield information needed to make recommendations for safe and     effective dosing of the drug in children. Children with reduced immune function-such as those     receiving drugs for cancer treatment-are at high risk for serious fungal infections.      Children between 2 and 12 years old who need treatment to prevent fungal infections may be     eligible for this study. Candidates will be screened with a physical examination, eye     examination, and blood and urine tests.      Children in the study will be hospitalized for 21 days. They will receive voriconazole twice     a day (every 12 hours) for 8 days, infused through a vein over a period of 1 to 2 hours. The     dose will be determined based on the individual child's weight. Blood samples will be     collected at various intervals before and after the infusions on days 1, 2, 4 and 8 to     determine the amount of drug in the blood. On day 8, the child will have another physical and     eye examination, as well as additional blood and urine tests. If additional treatment is     required, voriconazole may be continued for up to day 21. (Children who require the drug for     more than 21 days may receive it under another research protocol.) On the last day of     treatment, the child will have another physical examination, and blood and urine tests. These     procedures will be repeated again at 30 to 35 days following the last dose of drug. A small     sample of blood will also be analyzed for genetic information related to the rate of     metabolism of voriconazole-that is, how fast or slow it is cleared (eliminated) by the liver.      Voriconazole is effective against several different fungi. It may protect children against     serious fungal infections with fewer side effects than standard available therapy.   "
165217|NCT00005914|"     This nationwide study will create a DNA collection to permit qualified scientists to search     for depression-related genes.      More than 750 families with at least two siblings who have experienced major depression are     needed for the study. Participants will be interviewed about psychiatric and family history,     and will be asked to provide a small blood specimen. The identification of predisposing genes     can lead to greater understanding of the brain mechanisms involved in severe depression which     can in turn lead to the discovery of new treatments.      A Certificate of Confidentiality from the federal government ensures that all information     will be strictly confidential. Blood specimens are identified only by code number (not by     name).      Reimbursement is provided.   "
165218|NCT00005915|"     The purpose of this study is to compare 2 treatment plans to try to increase the effects of     anti-HIV drugs in patients who are resistant to the drug effects.      Sometimes the increase in a patient's viral load (the level of HIV in the blood) can be     slowed or stopped by taking anti-HIV drugs. This does not always happen. Sometimes anti-HIV     drugs work at first but then stop working. When most of the usual anti-HIV drugs no longer     seem to work, the virus is called multidrug-resistant (MDR). This study will compare 2     treatment plans to try to increase the effects of anti-HIV drugs in patients with MDR virus.   "
165219|NCT00005916|"     This study will test the ability of an experimental vaccine to increase the number of     tumor-fighting immune cells (lymphocytes) in patients with localized prostate cancer and     prevent the disease from recurring following radiation therapy. The vaccine is intended to     stimulate lymphocytes to target and attack cells containing a protein called prostate     specific antigen, or PSA. It is composed of the following parts:        -  rV-PSA: Vaccinia virus plus human DNA that produces PSA (prostate specific antigen)        -  rV-B7.1: Vaccinia virus plus human DNA that produces B7.1 (a protein that helps guide          immune cells to their targets)        -  rF-PSA: Fowlpox virus plus human DNA that produces PSA        -  GM-CSF: Drug that boosts the immune system.        -  IL-2: Drug that boosts the immune system.      Patients 18 years of age and older with prostate cancer confined to the prostate who have     received a smallpox vaccine sometime in the past and who do not have a history of allergy to     eggs may be eligible for this study. Candidates are screened with a complete medical history     and physical examination, blood tests, and skin tests (similar to those for allergies or     tuberculosis) to assess immune function.      Participants are randomly assigned to receive one of the following three treatments: Group 1     - standard radiation therapy plus the experimental vaccine; Group 2 - standard radiation     therapy without the vaccine; Group 3 - standard radiation therapy with the vaccine, but with     a different dose of IL-2 from Group 1.      Patients in the vaccine groups receive injections in the arm or thigh in 28-day treatment     cycles, as follows:        -  GM-CSF: Days 1 through 4 of the first week        -  IL-2 5: for Group 1, 5 days in the second week of each cycle; for Group 3, 14 days          beginning in the second week of each cycle        -  rV-PSA and rV-B7.1: Day 2 of the first cycle only        -  rF-PSA (booster shots): Every 28 days, beginning day 2 of the second cycle (i.e., days          30, 58, 86, etc.)      Treatment continues for eight cycles unless serious side effects develop, PSA levels rise     significantly, or the doctors feel there is no reason to continue therapy.      All patients undergo radiation therapy and possibly hormone therapy, if indicated. Blood     samples are drawn once a week for the first month and then once every 4 weeks to monitor     safety. After treatment ends, patients are followed with examinations and blood tests every 3     months for the first 2 years and then every 6 months until the doctors determine follow-up is     no longer needed or the cancer returns.      All patients have HLA tissue typing at the beginning of the study. Those who are type HLA-A2     are asked to have additional procedures for studying the immune response that can be done     only with this tissue type. This involves collecting blood samples before treatment begins,     every 4 weeks during treatment, once after cycle 2, and once 4 months after the eighth     vaccine. They also undergo four leukapheresis procedures for collecting white blood cells.     For leukapheresis, blood is collected through a needle in an arm vein, similar to donating a     unit of blood. The blood flows through a machine that separates it into its components. The     white cells are removed, and the red cells, platelets and plasma are returned to the body,     either through the same needle or through a needle in the other arm.   "
165220|NCT00005917|"     Chediak-Higashi syndrome (CHS) is a rare autosomal recessive disorder characterized in its     classical form by oculocutaneous albinism, a bleeding diathesis, recurrent infection due to     abnormal neutrophil and natural killer cell function, and eventual progression to a     lymphohistiocytic infiltration known as the accelerated phase . Death often occurs within the     first decade as a result of infection or the development of the accelerated phase; bone     marrow transplantation is curative except for the late occurrence of neurological     deterioration. The basic defect is unknown, although it probably involves abnormal fusion or     trafficking of intracellular vesicles. Patients with classical CHS have their disease due to     mutations in the LYST gene, but mildly affected individuals have been reported whose genetic     defect has not been defined. It is likely that these variants of CHS have abnormalities in     proteins involved in the pathways responsible for vesicle fusion. Since the full clinical     spectrum of CHS and its variants has not been characterized, and the underlying defects     remain enigmatic, we plan to evaluate this group of patients clinically, biochemically, and     molecularly, and perform cell biological studies on their fibroblasts, melanocytes, and     transformed lymphoblasts. Routine admissions will be 5 days and may occur every two years, or     required by changes in clinical symptomatology.   "
165221|NCT00005918|"     The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine     (d4T). One form is taken once a day (extended release) and the other form is taken twice a     day (immediate release).   "
165222|NCT00005919|"     The purpose of this study is to learn how pigment is released from the iris (the colored part     of the eye) in patients with pigment dispersion syndrome. It will do this by examining the     response of the pupil (the central opening of the iris) to a flash of light to determine what     is happening in the iris to cause release of the pigment.      In pigment dispersion syndrome, pigment released from the iris is deposited in other parts of     the eye, including the trabecular meshwork-a filter-like tissue in the front of the eye.     Aqueous fluid (fluid continuously produced by the eye) normally flows out of the eye through     the trabecular meshwork. In some patients, the pigment deposits may block tiny holes in the     meshwork, preventing the fluid from flowing out. This can cause an increase in eye pressure     that may lead to glaucoma and some loss of vision. Understanding how pigment is released from     the iris may help predict the course of pigment dispersion syndrome and identify which     patients will likely develop increased eye pressure.      Patients with pigment dispersion syndrome and normal volunteers may be eligible for this     study. All participants will have the following procedures, which will be completed in two     clinic visits:      First visit        1. Examination of the front of the eyes, including the cornea, iris and lens.        2. Vision testing and measurements of visual field and eye pressure.        3. Examination of the trabecular meshwork. For this test, a contact lens is placed on the          eye after the eye has been numbed with anesthetic drops.      Second visit        1. Refraction (dilation of the pupils with drops) and examination of the back of the eyes,          including the optic nerve.        2. Reaction of the pupils to low-level infrared light (pupillography). During this          15-minute test, the patient or volunteer wears a lightweight headband with two small          cameras mounted on it. The cameras-one which views the eye and the other the subject's          field of view-record pupil dilation and position.      The test results in patients with pigment dispersion syndrome will be compared with those in     normal volunteers. Patients will be followed every 6 months (or more often, if medically     indicated) during the 3-year study to determine changes in eye pressure or visual field.     Volunteers will be asked to return about once a year for 3 years for repeat pupillography.   "
165223|NCT00005920|"     The purpose of this study is to see if it is safe and effective to give L-743,872 to patients     with thrush, an AIDS-related yeast infection of the mouth, that has not been cured with     fluconazole treatment.   "
165224|NCT00005921|"     The purpose of this study is to see if it is safe to give L-743,872 to men with candidal     esophagitis, an AIDS-related yeast infection in the esophagus.   "
165225|NCT00005922|"     This study uses the psychological principle known as classical conditioning to try to improve     the standard treatment of psoriasis. Classical conditioning is a process of behavioral     modification in which a person learns to connect a certain response-in this case, improvement     of psoriasis-with a new action, or stimulus-in this case, application of an inactive cream.     The goal of this study is to show that people with psoriasis who are maintained on     corticosteroid cream part of the time and an inactive (placebo) cream at other times show a     lower incidence of relapse and a reduced severity of psoriasis that patients treated with     that same (reduced) amount of medication administered all the time.   "
165226|NCT00005923|"     The proposed research is an observational study designed to compare estrogen and progesterone     serum levels with knee and ankle joint laxity, and muscle reaction time as a measure of     neuromuscular function. Three groups of women athletes with differing estrogen and     progesterone profiles (normal menstrual cycles, amenorrheic, and exogenous estrogen     supplementation) and one control group (male collegiate athletes) will be used to compare     differences in joint laxity and neuromuscular function. Blood levels of estrogen and     progesterone will be measured at four time points across the menstrual cycle. Joint laxity     and muscle reaction time will also be measured at each of these points. The investigator     hypothesizes that knee and ankle joint laxity and muscle reaction time will significantly     increase with increasing estrogen and progesterone levels.   "
165227|NCT00005924|"     This study will examine the effects of long-term antiviral therapy with valaciclovir     (Valtrex) on Epstein-Barr virus infection. This virus infects more than 95 percent of people     in the United States. Most are infected in childhood, have no symptoms, and are unaware of     their infection. People infected as adolescents or adults may develop infectious     mononucleosis, which usually resolves completely. Once infected, most people shed the virus     from their throat occasionally, and all carry the virus in their white blood cells for life.     This study will determine whether the amount of virus in the blood declines or disappears     with long-term valaciclovir treatment.      Normal volunteers who are not taking any antiviral medicines and patients enrolled in NIH's     protocol no. 97-I-0168 (Evaluation of Valaciclovir for Prevention of Herpes Simplex Virus     Transmission) or Glaxo-Wellcome protocol HS2AB 3009 at collaborating centers may be eligible     for this study. Patients in the multi-center study must be about to start valaciclovir     therapy for at least 1 year. All candidates must be 18 years of age or older.      Study participants will be seen in clinic for about 1 hour every 3 months for a year. During     these visits, they will provide information about the medicines they are taking, gargle twice     with salt water and spit the fluid into a tube, and have blood drawn (no more than 8     teaspoons each visit). The blood and gargled fluid will be tested for the amount of     Epstein-Barr virus and antibodies to the virus. (Blood samples will also be tested for HLA     type in order to do immunologic studies in the laboratory. HLA is a marker of the immune     system that is similar to blood-typing testing.)      The results in people taking valaciclovir will be compared with those in people not taking     the drug. People whose results show the virus has disappeared from the body will continue to     be followed twice a year for 5 years with the blood and gargling tests to continue to look     for evidence of virus. Also, people who develop symptoms resembling mononucleosis (e.g.,     enlarged lymph nodes with fever and sore throat) will be asked to have their blood tested for     the virus.   "
165228|NCT00005925|"     This study will examine the safety and effectiveness of infusing a chemical called muscimol     into the brain to control seizures in patients with intractable epilepsy (frequent seizures     that persist despite therapy). Muscimol, which is similar to a naturally occurring brain     chemical called GABA, has been shown to reduce seizures in rats. After the infusion study,     patients will undergo a standard surgical procedure for controlling seizures.      Patients 18 years of age or older with intractable epilepsy may be eligible for this study.     Before entering protocol 00-N-0158, candidates will be screened under protocol 01-N-0139,     Evaluation and Treatment of Patients with Epilepsy, with a medical history, physical and     neurologic examination, chest X-ray, electrocardiogram, blood and urine tests,     electroencephalographic (EEG) monitoring and magnetic resonance imaging (MRI) of the head.      Patients enrolled in this study will have the following procedures:        1. Computerized tomography (CT) and magnetic resonance imaging (MRI) of the head to guide          catheter/electrode placement (see #2).        2. Depth catheter/electrode placement into the presumed location of the seizure focus (the          part of the brain where the seizures originate) - A small hole is drilled through the          skull. A depth electrode with a hole in the center of the tubing is passed through the          brain into the structures usually involved in intractable epilepsy. MRI will be done to          check electrode placement. Video-EEG monitoring will continue for 5 days for this part          of the study. Patients will be tested for their ability to understand and produce          speech, see normally, move their arms and legs, distinguish sharp and dull objects, and          put pegs in a pegboard. They will be questioned about headache, weakness, numbness or          sleepiness. The electrode will be left in place for muscimol infusion (see #3).        3. Muscimol infusion - Into the seizure focus, patients will be given two infusions-one of          saline (salt water) alone and one of muscimol diluted in saline. Each infusion will be          given over a period of one-half to 5 1/2 days, infused at the rate of 0.1 ml (1/50th of          a teaspoon) per hour. During the infusions video-EEG recordings will continue and          patients will be interviewed and examined as described in #2 above).        4. Blood testing - About 2 tablespoons of blood will be drawn daily during the testing          period and for the first 2 days after surgery (see #5).        5. Surgery - Temporal lobectomy or topectomy (removal of a small, specific area of brain          tissue) is the standard surgical treatment for medically intractable epilepsy whose          seizure focus is not in a critical brain region, such as an area that controls language,          movement, or sensation. If the patient's seizures arise from one of these areas, an          alternative procedure called multiple subpial transection will be offered. In this          procedure, vertical cuts are made in the seizure focus to prevent neurons (nerve cells          that transmit electrical impulses) in the focus from spreading the seizure to the rest          of the brain.        6. Surgery follow-up - Patients will be monitored in the surgical intensive care unit for          24 to 48 hours and then in the NINDS nursing unit for 4 to 8 days before being          discharged to home. Another visit in the NINDS outpatient clinic will be scheduled for          6-12 weeks after surgery.   "
165229|NCT00005926|"     This study will examine the safety and effectiveness of the drugs Gemcitabine and Herceptin,     given in conjunction with radiation therapy, for treating patients with cancer of the     pancreas. Gemcitabine is standard therapy for advanced pancreatic cancer. It damages tumor     cells and may enhance the effects of radiation therapy. Herceptin is a genetically engineered     antibody that has prevented some tumors from growing in patients with breast cancer. Because     breast and pancreatic cancer cells share an characteristic related to how Herceptin works     (similar HER-2/neu receptor proteins), it is thought that this drug may also inhibit growth     of tumors of the pancreas.      Patients with pancreatic cancer may be eligible for this study. Candidates will be screened     with a physical examination, chest X-ray, blood tests, electrocardiogram, and computerized     tomography (CT) scan of the chest, abdomen and pelvis. They will also have a minor surgical     procedure called a laparoscopy to evaluate the extent of their cancer. This procedure, done     under general anesthesia, requires an overnight hospital stay. A small incision (about 1     inch) is made in the abdomen and a thin, flexible tube with a light and special fibers at the     end is inserted into the opening. This device, called a laparoscope, allows the surgeon to     see inside the abdominal cavity to evaluate the tumor and also to remove a small piece of     tumor tissue for examination.      Patients accepted into the study will be assigned to one of two treatment groups, according     to whether or not their tumor can be removed with surgery. Patients will be asked to complete     a Quality of Life Evaluation before treatment begins and again at each follow-up visit. This     15-minute questionnaire assesses patients' feelings, their ability to carry out usual     activities, and the effects of therapy on their general health and well being.      Patients in both treatment groups will be given the same chemotherapy, on an outpatient basis     unless special circumstances require hospitalization. Gemcitabine is infused over 30 to 60     minutes through an intravenous catheter (IV)-a thin plastic tube inserted into an arm vein.     Herceptin is then given over 30 to 90 minutes through the same IV line. Radiation therapy to     the abdomen will start the same day, after the drugs have been administered, and will     continue for the next 4 days. This treatment cycle-chemotherapy plus 5 days of radiation     therapy-will be repeated each week for 6 weeks.      Within 6 weeks after the last treatment, the patient's tumor will be evaluated with a blood     test and CT scan of the chest, abdomen and pelvis to determine if it can be removed with     surgery. If so, the procedure will be done under general anesthesia and will require a 7- to     10-day hospital stay. If the tumor cannot be removed with surgery, another biopsy will be     taken to evaluate the tumor's response to the chemotherapy and radiation treatment.      All patients will receive additional chemotherapy beginning 6 weeks after surgery (for     patients whose tumors were removed) or 6 weeks after radiation therapy (for patients whose     tumors could not be removed). Gemcitabine and Herceptin will be given IV once a week for 3     weeks followed by a week of rest. This 4-week treatment cycle will be repeated up to six     times.      After treatment ends, patients will be evaluated with CT scans or X-rays and blood tests     every 3 to 4 months for the first 2 years and every 6 months thereafter to evaluate disease     status.   "
165236|NCT00005936|"     This study will examine liver tissue to investigate the role of viral infections in fulminant     hepatitis, liver failure, and profound bone marrow failure.      All patients who are undergoing liver biopsy or liver transplantation may participate in this     study. For patients undergoing liver biopsy, a small piece of liver tissue will be taken from     the sample collected during the scheduled biopsy. For patients undergoing liver     transplantation, a small piece of tissue will be collected from the diseased liver that is to     be removed.   "
165320|NCT00005125|"     To continue a registry of World War II veteran twins maintained by the National Academy of     Sciences-National Research Council (NAS-NRC).   "
165230|NCT00005927|"     The adrenal glands, located atop the kidneys, normally produce several types of hormones.     Tumors of these glands may or may not secrete hormones. It is not known what causes these     tumors or why some secrete hormones and others do not. Some of the tumors are benign and     confined to the adrenal gland, and others are malignant (cancerous), and can spread to other     parts of the body. This study will investigate how adrenal gland tumors develop, why some     secrete steroid hormones and others do not, and why some are benign and others malignant.      Patients between 3 and 70 years old with a known or suspected adrenal gland tumor may be     eligible for this study. Participants will be hospitalized for 7 to 10 days for various tests     and procedures that may include the following:        1. Medical history and physical examination, including body measurements, as appropriate.          Children and adolescents will have Tanner staging, including examination of the          genitals, to determine the extent of sexual maturity.        2. 24-hour urine collection to measure hormones in the urine.        3. Imaging studies, including magnetic resonance imaging (MRI) of the brain, computed          tomography (CT) and other X-ray studies.        4. Blood tests to see if the tumor secretes hormones in response to specific stimuli,          including exercise, food, and various hormones. The hormones are given through an          intravenous catheter, or IV a thin plastic tube inserted into an arm vein. After the          stimulus, blood is drawn through the same IV every 30 minutes for up to 3 hours to          measure hormone levels. Based on the results of these tests, some patients may have          additional blood tests to check hormone response to special foods, an IV salt solution,          or other hormones or drugs given either IV or by mouth (in pill form).        5. Photographs to document the effects on the body of abnormal hormone secretion from the          adrenal tumor.        6. Small samples of blood and tumor tissue for research and DNA (genetic) analysis.      A discussion of treatment options will be based on the results of tests. If surgery to remove     the tumor is recommended, the procedure can be done at NIH under this study protocol. If a     malignant tumor is found that cannot be treated surgically, chemotherapy or radiation therapy     may be recommended. These options are not offered under this protocol, but may be available     under a different NIH study (for example, at the National Cancer Institute). Referrals will     be made at the patient s request.      Patients who had surgery may be followed at the NIH outpatient clinic for 1 year after     surgery. Patients with certain types of tumors may continue to be followed at NIH once a year     for up to 5 years.      A registry of study participants will be created to keep records and correlate medical     histories with tissues kept at NIH. The registry will also be used to inform participants of     research studies they may be interested in. No individuals or organizations outside of NIH     will have access to the registry.   "
165231|NCT00005928|"     This study will determine the effects of angiotensin-converting enzyme (ACE) inhibitor (trade     name Ramipril) therapy on inflammation and stiffness of artery walls. These are two risk     factors for developing atherosclerosis-deposits of fatty substances called plaques that can     block the blood vessel, causing a heart attack or stroke. Studies of patients with coronary     artery disease suggest that ACE inhibitor therapy reduces the risk of heart attack and heart     failure. This study will examine the effects of this treatment on the artery walls and on     levels of substances in the blood that indicate blood vessel inflammation.      Patients between 40 and 75 years old with coronary artery disease caused by atherosclerosis     may be eligible for this study. Candidates will be screened with a medical history,     cardiovascular (heart and blood vessel) examination, electrocardiogram and blood tests. Those     enrolled will be randomly assigned to take either an ACE inhibitor pill or a placebo     (look-alike pill with no medicine) once a day for 3 months. No pills will be taken for the     next month, and then participants will take the alternate pill for the next 3 months. That     is, those who took ACE inhibitor for the first 3-month period will take placebo for the     second 3-month period and vice versa. Blood pressures will be taken at the NIH Clinical     Center or by the patient's physician at the end of the first and second weeks of the study.     At the end of 3 weeks, patients will return to the Clinical Center for a blood draw of 6 cc     (1/2 teaspoon) to assess kidney function. In addition, at the end of each 3-month study     period, patients will undergo the following procedures at the Clinical Center:        1. Fasting blood draw of 60 cc (2 ounces) to measure electrolytes (e.g., sodium and          potassium) and blood markers for inflammation        2. Ultrasound (use of sound waves to create pictures) study of the carotid arteries          (arteries in the neck leading to the brain)-An ultrasound probe is applied gently on the          neck, and ultrasound pictures of the right and left carotid arteries are recorded on          tape. Heart activity and blood pressure are monitored during the procedure with an          electrocardiogram and blood pressure cuff.        3. Magnetic resonance imaging (MRI) of the carotid arteries-The patient lies on a table in          a narrow cylinder (the MRI machine) containing a magnetic field. A flexible padded          sensor called a MRI coil is placed over the neck area. Earplugs are placed in the ear to          muffle the loud thumping sounds the machine makes when the magnetic fields are switched.          During the second half of the exam, a contrast agent (gadolinium) is injected through an          intravenous catheter (flexible tube placed in a vein) to brighten the images. The heart          is monitored during the procedure with an electrocardiogram.   "
165232|NCT00005931|"     The purpose of this study is to test the effectiveness of SU5416 in patients with     AIDS-related Kaposi's sarcoma (KS).   "
165233|NCT00005933|"     This study will try to determine what causes learning, behavioral and emotional problems in     children with chronic granulomatous disease (GCD) and other phagocyte disorders. (Phagocytes     are a type of white blood cell.) Children with these disorders have frequent severe     infections that require hospitalization, sometimes for long periods of time. Many of them     also have problems with school, learning, behavior, anxiety and depression. This study will     explore whether these latter problems are a direct result of the illness itself or are a     consequence of frequent, long hospitalizations, or are due to other factors. Test findings in     these children will be compared with those of children with cystic fibrosis-another disease     that causes frequent infections requiring prolonged hospitalization.      Patients age 2 or older with GCD or other phagocytic disorders or cystic fibrosis may be     eligible for this study. Participants (or a parent or guardian) will complete questionnaires     including personal information such as age, gender and marital status, a family medical     history, and information on their illness. Patients will be given various psychological and     intelligence tests, and they and their parents or guardians will be interviewed by a child     psychiatrist. The tests and interviews take a total of about 5 hours and are given in two or     three separate sessions.      The tests may reveal problems such as learning disorders, attention-deficit hyperactivity     disorder, anxiety, or depression. If any of these problems are identified, appropriate     referrals will be made for specialized services, such as special school placement, tutoring,     or counseling.   "
165234|NCT00005934|"     This study will evaluate the safety and effectiveness of 5-azacytidine and phenylbutyrate for     treating thalassemia major. Patients with this disease have abnormal production of hemoglobin     (the oxygen-carrying protein in red blood cells), which leads to red blood cell destruction.     As a result, patients require frequent red cell transfusions over many years. Because of     these transfusions, however, excess iron is deposited in various body organs-such as the     heart, liver, thyroid gland and, in men, the testes-impairing their function.      Fetal hemoglobin-a type of hemoglobin that is produced during fetal and infant life-can     substitute for adult hemoglobin and increase the levels of red cells in the body. After     infancy, however, this type of hemoglobin is no longer produced in large quantities.     5-azacytidine can increase fetal hemoglobin levels, but this drug can damage DNA, which in     turn can increase the risk of cancer. This study will try to lessen the harmful effects of     5-azacytidine by using only one or two doses of it, followed by long-term therapy with     phenylbutyrate, a drug that may be as effective as 5-azacytidine with less harmful side     effects.      Patients 18 years of age and older with severe thalassemia major may be eligible for this     study. Before beginning treatment, candidates will have a medical history and physical     examination, blood tests, chest X-ray, electrocardiogram (EKG), bone marrow biopsy (removal     of a small sample of bone marrow from the hip for microscopic examination) and whole-body     magnetic resonance imaging (MRI). For the biopsy, the area of the hip is anesthetized and a     special needle is inserted to draw bone marrow from the hipbone. For the MRI scan, a strong     magnetic field is used to produce images that will identify sites where the body is making     red blood cells. During this procedure, the patient lies on a table in a narrow cylinder     containing a magnetic field. Earplugs are placed in the ears to muffle the loud thumping     sounds the machine makes when the magnetic fields are being switched.      An intravenous (IV) catheter (flexible tube inserted into a vein) is placed in a large vein     of the patient's neck, chest or arm for infusion of 5-azacytidine at a constant rate over 4     days. Patients who do not respond to this first dose of 5-azacytidine will be given the drug     again after about 50 days. If they do not respond to the second dose, alternate treatments     will have to be considered. Patients who respond to 5-azacytidine will begin taking     phenylbutyrate on the 14th day after 5-azacytidine was started. They will take about 10 large     pills 3 times a day, continuing for as long as the treatment is beneficial. All patients will     be hospitalized for at least 6 days starting with the beginning of 5-azacytidine therapy.     Those who are well enough may then be discharged and continue treatment as an outpatient.      Patients will be monitored with blood tests daily for 2 weeks and then will be seen weekly     for about another 5 weeks. Bone marrow biopsies will be repeated 6 days after treatment     begins and again at 2 weeks and 7 weeks. MRI will be repeated 7 weeks after treatment begins.     After 7 weeks, patients will be seen at 3-month intervals. Bone marrow biopsies will be done     every 6 months for the first 3 years after treatment. Patients will have red cell     transfusions as needed and chelation therapy to remove excess iron.   "
165235|NCT00005935|"     This study will examine the safety and effectiveness of a new drug combination for treating     patients with severe aplastic anemia. Patients with aplastic anemia produce too few blood     cells, causing fatigue, easy bruising and bleeding, and susceptibility to infections. In many     cases, the very low blood counts result from an autoimmune process-that is, the patient's own     immune system suppresses production of blood cells by the bone marrow. Although     immune-suppressing drugs, such as cyclosporine, can restore normal cell counts, many patients     have disease relapses. These patients require long-term therapy with cyclosporine, which can     cause harmful side effects. This study will examine whether a lower dose of cyclosporine     given together with mycophenolate mofetil (MMF) can maintain blood counts as effectively as     full-dose cyclosporine treatment, and whether MMF alone can reduce the chances of future     relapses.      Patients 4 years of age and older with severe aplastic anemia who have relapsed after immune     suppressing therapy may be eligible for this study. Participants will be randomly assigned to     receive either standard cyclosporine therapy or experimental therapy with cyclosporine and     MMF.      Patients receiving standard cyclosporine therapy will receive a full dose of the drug for at     least 3 months. Those taking both cyclosporine and MMF will take MMF plus half-dose     cyclosporine for 3 months and continue MMF for an additional 6 months. Both drugs are taken     twice a day by mouth. All patients will have about 120 milliliters (4 ounces) of blood drawn     at the beginning of the study to evaluate immune system activity and bone marrow function,     and to look for genetic material of certain viruses. Bone marrow aspirations and biopsies     will be done at the beginning of the study, and at 6 and 12 months. For these tests, the area     of the hip is anesthetized and a special needle is used to draw bone marrow from the hipbone.      The patient's local doctor will be asked to do blood tests for chemistries, liver function     and cyclosporine levels weekly for the first month and then every other week. Patients will     return to NIH for evaluations 3, 6 and 12 months after treatment and then once a year. About     100 ml (7 tablespoons) of blood will be drawn at each visit.   "
165249|NCT00005949|"     Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating     patients who have advanced melanoma. Vaccines made from a person's cancer cells may make the     body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's     white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more     cancer cells   "
165237|NCT00005937|"     This study will determine the safety and effectiveness of a combination of the     immune-suppressing drugs antithymocyte globulin (ATG) and cyclosporine for treating     myelodysplasia, a disorder of low blood cell counts. It will: evaluate whether this drug     combination can increase blood counts in patients and reduce their need for transfusions;     compare survival of patients who respond to ATG and cyclosporine treatment with those who do     not respond; and determine the side effects of the treatment.      Myelodysplasia is thought to result from an immune system abnormality in which cells called     lymphocytes attack the marrow's blood-forming cells. The resulting deficiencies of platelets     and red and white blood cells cause anemia, susceptibility to infections, and easy bruising     and bleeding. Various therapies, such as blood transfusions for anemia and bleeding,     antibiotics for infection, chemotherapy and bone marrow transplantation are used to treat     myelodysplasia, but all have disadvantages and some carry serious risks.      Patients 18 years of age and older with myelodysplasia may be eligible for this study.     Candidates will be screened with a physical examination and medical history, blood tests,     chest X-ray, electrocardiogram and bone marrow biopsy (removal of a marrow sample from the     hipbone for microscopic examination).   "
165238|NCT00005938|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have     biliary cancer.   "
165239|NCT00005939|"     RATIONALE: Radiation therapy uses high-energy radiation to damage tumor cells. Brachytherapy     uses radioactive material that is placed directly into or near the tumor. Brachytherapy may     kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating patients     who have recurrent prostate cancer that has not responded to standard therapy.   "
165240|NCT00005940|"     This phase II trial studies how well iodine I 131 monoclonal antibody BC8, busulfan, and     cyclophosphamide followed by donor stem cell transplant works in treating patients with acute     myeloid leukemia that has decreased or disappeared, but the cancer may still be in the body.     Giving chemotherapy drugs, such as busulfan and cyclophosphamide before a donor peripheral     blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop     the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled     monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells     and carry cancer-killing substances to them without harming normal cells. When the stem cells     from a related donor, that closely matches the patient's blood, are infused into the patient     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,     and platelets.   "
165241|NCT00005941|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.     It also stops the patient's immune system from rejecting the donor's stem cells. The donated     stem cells may replace the patient's immune system and help destroy any remaining cancer     cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor     lymphocyte infusion) after the transplant may help increase this effect. Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from     happening.      PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant plus     chemotherapy and total-body irradiation followed by donor white blood cell infusion work in     treating patients with recurrent metastatic or locally advanced cancer of the cervix or     vagina that is associated with human papillomavirus.   "
165242|NCT00005942|"     Phase I/II trial to study the effectiveness of liposomal daunorubicin and SU5416 in treating     patients who have hematologic cancer that has not responded to initial therapy. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. SU5416 may stop the growth of hematologic cancer by stopping blood flow to the cancer   "
165243|NCT00005943|"     RATIONALE: Inserting the gene for interleukin-2 into a person's melanoma cells may make the     body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who     have metastatic melanoma.   "
165244|NCT00005944|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor     cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of second-look surgery with     or without intraperitoneal infusions of mitomycin and fluorouracil in treating patients who     have colorectal cancer that is recurrent to the peritoneum.   "
165245|NCT00005945|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not     yet known which combination chemotherapy regimen is more effective in treating childhood     acute lymphoblastic leukemia.      PURPOSE: This randomized phase III trial is comparing different combination chemotherapy     regimens to see how well they work in treating children with acute lymphoblastic leukemia.   "
165246|NCT00005946|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. White blood cells from donors may be able to prevent     graft-versus-host disease in patients with hematologic cancer that has relapsed following     donor peripheral stem cell transplantation.      PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus donor white blood cell     infusion in treating patients who have relapsed hematologic cancer following donor peripheral     stem cell transplantation.   "
165247|NCT00005947|"     Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not     yet known if vaccine therapy is effective for prostate cancer.      Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in     treating patients who have metastatic prostate cancer that has not responded to hormone     therapy.   "
165248|NCT00005948|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Biological therapies use different ways to stimulate the immune     system and stop cancer cells from growing. Peripheral stem cell transplantation may be able     to replace immune cells that were destroyed by chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral     stem cell transplantation and biological therapy in treating patients who have chronic     myelogenous leukemia.   "
165252|NCT00005952|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide     when given with peripheral stem cell transplantation and to see how well they work in     treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other     solid tumors.   "
165253|NCT00005954|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who     have brain metastases.   "
165254|NCT00005955|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Chemotherapy combined with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by radiation     therapy in treating children who have newly diagnosed malignant central nervous system     tumors.   "
165255|NCT00005956|"     RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an     immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients     who have advanced cancer that shows no signs of disease following treatment.   "
165256|NCT00005957|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the     tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation     therapy to the breast alone following surgery is more effective than radiation therapy to the     breast plus surrounding tissue in treating invasive breast cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to     see how well it works compared to radiation therapy to the breast plus surrounding tissue in     treating women who have undergone surgery for early-stage invasive breast cancer.   "
165257|NCT00005958|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with     gemcitabine and docetaxel plus filgrastim in treating patients who have locally recurrent or     advanced urothelium cancer.   "
165258|NCT00005959|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Combining more than one chemotherapy drug with rituximab may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab plus combination chemotherapy     in treating patients who have intermediate-grade or high-grade non-Hodgkin's lymphoma.   "
165259|NCT00005960|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have prostate cancer that has not responded to hormone therapy.   "
165260|NCT00005060|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug with surgery may kill     more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective     than surgery followed by chemotherapy for stomach cancer.      PURPOSE: This randomized phase III trial is studying surgery followed by combination     chemotherapy to see how well it works compared to combination chemotherapy followed by     surgery in treating patients with locally advanced stomach cancer.   "
165261|NCT00005061|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have relapsed or refractory solid tumors.   "
165262|NCT00005062|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the     spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more     effective than high-dose radiation therapy in preventing the spread of limited-stage small     cell lung cancer cells to the brain.      PURPOSE: This randomized phase III trial is comparing two different regimens of radiation     therapy to see how well they work in treating patients with limited-stage small cell lung     cancer in complete remission.   "
165263|NCT00005064|"     Phase I trial to study the effectiveness of PS-341 in treating patients who have refractory     or relapsed acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia in     blast phase, or myelodysplastic syndrome. PS-341 may stop the growth of cancer cells by     blocking the enzymes necessary for cancer cell growth   "
165264|NCT00005065|"     Phase I trial to study the effectiveness of combining carboplatin and paclitaxel, radiation     therapy with gadolinium texaphyrin, and surgery in treating patients who have stage IIIA     non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to     damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more     sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and surgery may     kill more tumor cells.   "
165265|NCT00005066|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining O6-benzylguanine and     carmustine in treating patients who have recurrent, metastatic, or locally advanced soft     tissue sarcoma.   "
165266|NCT00005067|"     This phase I trial is studying the side effects and best dose of photodynamic therapy with     lutetium texaphyrin in treating patients with locally recurrent prostate cancer. Photodynamic     therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor     cells. This may be effective treatment for locally recurrent prostate cancer.     Photosensitizing drugs, such as lutetium texaphyrin, are absorbed by cancer cells and, when     exposed to light, become active and kill the cancer cells   "
165267|NCT00005068|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to determine the effectiveness of two different regimens of     combination chemotherapy in treating patients who have metastatic or unresectable solid     tumors.   "
165268|NCT00005069|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have metastatic kidney cancer.   "
165269|NCT00005070|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have     stage IVB or recurrent cervical cancer.   "
165270|NCT00005071|"     RATIONALE: Diagnostic procedures and treatment-planning systems may affect outcome in     patients suspected of having lung cancer.      PURPOSE: Randomized diagnostic trial to compare the effectiveness of two types of diagnostic     and treatment-planning systems in patients who are suspected of having lung cancer.   "
165271|NCT00005072|"     RATIONALE: Inserting the gene for interleukin-2 into a person's prostate cancer cells may     make the body build an immune response to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of Leuvectin in treating patients who     have locally recurrent prostate cancer after receiving treatment with radiation therapy.   "
165272|NCT00005073|"     RATIONALE: Zoledronate may be able to prevent bone metastases caused by prostate cancer. It     is not yet known if zoledronate is effective in preventing the spread of prostate cancer to     the bones.      PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate plus     standard therapy in preventing bone metastases in patients who have recurrent prostate cancer     that is not causing symptoms.   "
165273|NCT00005074|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who     have previously untreated or relapsed mantle cell lymphoma.   "
165274|NCT00005075|"     RATIONALE: Ultrasound therapy kills tumor cells by heating them to several degrees above body     temperature. This treatment may be effective for prostate cancer.      PURPOSE: Phase III trial to determine the effectiveness of ultrasound therapy in treating     patients who have stage I or stage II prostate cancer that has recurred following radiation     therapy.   "
165275|NCT00005076|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die.      PURPOSE: Phase II trial to study the effectiveness of cetuximab and irinotecan in treating     patients who have advanced colorectal cancer that has not responded to previous treatment.   "
165276|NCT00005077|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating patients who     have advanced cancer plus liver dysfunction.   "
165277|NCT00005078|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining tirapazamine, carboplatin, and     paclitaxel in treating patients who have advanced malignant solid tumors.   "
165278|NCT00005079|"     RATIONALE: The timing of breast cancer surgery within the menstrual cycle may affect outcome.     It is not yet known if treatment is more effective during the initial or final phase of the     menstrual cycle.      PURPOSE: Phase III trial to determine the effect of menstrual cycle phase at surgery in     treating premenopausal women who have stage I, stage II, or stage III breast cancer.   "
165279|NCT00005080|"     Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma     that has not been treated previously or that has not responded to previous treatment. Drugs     used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die   "
165280|NCT00005081|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining carmustine and     O6-benzylguanine in treating patients who have recurrent or progressive glioma.   "
165281|NCT00005082|"     RATIONALE: New imaging procedures such as magnetic resonance imaging may improve the ability     to detect the extent of newly diagnosed cancer.      PURPOSE: Diagnostic study of magnetic resonance imaging to determining the extent of cancer     in patients who have newly diagnosed glioma.   "
165282|NCT00005083|"     RATIONALE: New imaging procedures, such as functional magnetic resonance imaging and     1H-nuclear magnetic resonance spectroscopic imaging, may improve the ability to detect the     extent of cancer in the brain.      PURPOSE: Phase II trial to study the effectiveness of functional magnetic resonance imaging     and 1H-nuclear magnetic resonance spectroscopic imaging in treating patients who have newly     diagnosed brain tumors.   "
165283|NCT00005084|"     RATIONALE: New imaging procedures such as magnetic resonance imaging may improve the ability     to determine the growth rate of progressive astrocytoma.      PURPOSE: Phase II trial to study the effectiveness of magnetic resonance imaging in treating     children who have progressive low-grade astrocytoma.   "
165284|NCT00005085|"     Phase II trial to study the effectiveness of rebeccamycin analog in treating patients who     have metastatic or locally recurrent colorectal cancer. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die.   "
165285|NCT00005086|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have stage IV locally advanced or metastatic bladder cancer.   "
165321|NCT00005126|"     To conduct a baseline survey on cardiovascular, respiratory, and other major systemic disease     and risk factors in members of the Vietnam Era Twin Registry.   "
165286|NCT00005087|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy. Radiation therapy uses     high-energy x-rays to damage tumor cells.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel, cisplatin, and filgrastim     combined with radiation therapy in treating patients who have locally recurrent head and neck     cancer and have received previous treatment with radiation therapy.   "
165287|NCT00005088|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cisplatin in     treating patients who have advanced head and neck cancer.   "
165288|NCT00005089|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer     cells and either kill them or deliver cancer-killing substances to them without harming     normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining     chemotherapy with monoclonal antibody therapy and radiation therapy may kill more cancer     cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab     and radiation therapy in treating patients who have stage I or stage II non-Hodgkin's     lymphoma.   "
165289|NCT00005090|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It     is not yet known if combination chemotherapy is more effective with or without peripheral     stem cell transplantation in treating Hodgkin's Disease.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without peripheral stem cell transplantation in treating men who have stage III or     stage IV Hodgkin's disease.   "
165290|NCT00005091|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have     previously untreated stage IIIB or stage IV non-small cell lung cancer.   "
165291|NCT00005092|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by the chemotherapy or radiation therapy used to kill tumor cells. Sometimes the     transplanted cells are rejected by the body's normal tissues. Transplanting donated cells     that have been treated with psoralen may prevent this from happening.      PURPOSE: Phase I trial to study the effectiveness of chemotherapy, radiation therapy, and     psoralen-treated donor cells in treating patients who are undergoing peripheral stem cell     transplantation for hematologic cancer.   "
165292|NCT00005093|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether gemcitabine plus CI-994 is more     effective than gemcitabine alone for non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or     without CI-994 in treating patients who have advanced non-small cell lung cancer.   "
165293|NCT00005094|"     Chemoprevention therapy is the use of certain drugs to try to prevent the development of     cancer. The use of celecoxib has been approved for use in reducing the number of adenomatous     colorectal polyps in familial adenomatous polyposis (FAP). It is not known whether there is a     clinical benefit from a reduction in the number of colorectal polyps in FAP patients. The use     of celecoxib may be an effective way to prevent the development of sporadic adenomatous     polyps, precursors of colorectal cancer. This randomized phase III trial is studying     celecoxib to see how well it works compared to a placebo in preventing the development of     adenomatous colorectal polyps in patients who have had at least one polyp removed.   "
165294|NCT00005095|"     RATIONALE: To improve strategies for detection and prevention of early-stage disease.      PURPOSE: This research study is collecting specimens and data to develop better methods for     early detection and prevention of ovarian cancer among the high risk population and those who     have the disease.   "
165295|NCT00005096|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have     stage II or stage III prostate cancer.   "
165296|NCT00005097|"     RATIONALE: Green tea extract contains ingredients that may inhibit the growth of actinic     keratosis.      PURPOSE: Randomized phase II trial to determine the effectiveness of green tea extract in     treating patients who have actinic keratosis.   "
165297|NCT00005098|"     OBJECTIVES:      I. Establish cell lines from patients with alpha 1-antitrypsin deficiency in order to examine     genetic traits that predispose to liver injury.   "
165298|NCT00005100|"     OBJECTIVES: I. Compare growth hormone (GH) levels at baseline and after glucose suppression     measured with both a polyclonal radioimmunoassay and a highly sensitive immunoradiometric     assay (IRMA) in patients with acromegaly and normal volunteers.      II. Measure the levels of IGF-I and its binding protein, IGFBP-3, in these cohorts.      III. Determine any correlation between levels of IGF-I and IGFBP-3 and GH suppressibility as     assessed by sensitive IRMA.      IV. Determine if patients who demonstrate biochemical features of mild GH excess are at risk     for progression to active disease.   "
165299|NCT00005101|"     OBJECTIVES:      I. Determine the possible causes of bone loss in premenopausal or perimenopausal women.   "
165300|NCT00005102|"     OBJECTIVES:      I. Determine the pattern of immunologic reconstitution in patients with T-cell compromise due     to DiGeorge syndrome or velocardiofacial syndrome.      II. Determine any correlation between immunologic function in these patients and chromosome     22 deletion breakpoints.      III. Determine presence of sustained immunologic compromise in older patients.   "
165322|NCT00005127|"     To conduct longitudinal and cross-sectional studies of risk factors for coronary heart     disease and hypertension in school age children and adults who had been examined in previous     screens.   "
176472|NCT00154349|"     The objective of this study is to determine the efficacy and safety of imatinib mesylate in     patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia     (ALL).   "
165301|NCT00005103|"     OBJECTIVES: I. Determine the effect of standard treatments on various predisposing factors in     patients with porphyria cutanea tarda (PCT).      II. Investigate alcohol history, smoking, liver dysfunction and its etiology, estrogen use,     and family history of PCT in these patients.      III. Study the relationships of excess iron and the hemochromatosis gene to PCT, including     clinical features and risk of recurrence in these patients.      IV. Assess hepatitis C virus infections in these patients. V. Assess vitamin C levels in     these patients before and after treatment. VI. Assess dietary habits in these patients. VII.     Assess activity of cytochrome P450 enzymes (CYP) in vivo in these patients.      VIII. Study polymorphic genes for enzymes that metabolize foreign chemicals, including CYP     enzymes and glutathione transferases in these patients.   "
165302|NCT00005104|"     OBJECTIVES:      I. Determine whether reduction of serum insulin levels by metformin increases ovulatory     response to clomiphene citrate in women with polycystic ovary syndrome.   "
165303|NCT00005105|"     OBJECTIVES:      I. Determine if mutations in the gene encoding the insulin-like growth factor-I receptor lead     to relative insulin-like growth factor-I insensitivity and produce intrauterine growth     retardation in children.   "
165304|NCT00005106|"     The purpose of this study is to look at the effects of different anti-HIV drug combinations     on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.   "
165305|NCT00005107|"     This study is to determine whether a compound, nitric oxide, made within the body, is the     factor responsible for the changes in blood pressure and renal (kidney) functions that may     occur during the course of cirrhosis. Patients with cirrhosis (liver scarring which causes     poor liver function) will be eligible to participate. A group of healthy subjects will also     be studied to compare the effects of the treatment to patients with cirrhosis and to confirm     safety. A total number of 30 patients with cirrhosis and 10 healthy subjects will be enrolled     in the study.   "
165306|NCT00005108|"     This study will determine the effects of hormone replacement therapy (estrogen alone or     estrogen and progesterone) on the walls of arteries in postmenopausal women. Inflammation and     stiffness of artery walls are two risk factors for atherosclerosis-deposits of fatty     substances (plaques) that can block the vessel, causing a heart attack or stroke. Estrogen     raises the levels of certain substances in the blood that cause vessel inflammation and     lowers the levels of others. This study will measure the net effects of estrogen on artery     wall inflammation and stiffness.      Postmenopausal women in good health may participate in this study. Volunteers will be     screened for eligibility with a complete medical history, heart examination, and blood tests.     Participants will be randomly assigned to receive either: 1) hormone therapy (estradiol 2 mg     daily alone for women who have had a hysterectomy or estradiol plus micronized progesterone     200 mg daily for women with an intact uterus); or 2) placebo (look-alike pills that contain     no active drug). Women in both groups will take pills for 3 months, then no pills for 1     month, and then will crossover to the alternate therapy for 3 months (i.e., those in the     original placebo group will take hormones, and those in the hormone group will take placebo).     At the end of each 3-month treatment period, participants will undergo the following     procedures to assess blood vessel inflammation and stiffness:        1. Blood tests - 60 cc (about 2 ounces) of blood will be drawn to measure levels of          hormones, cholesterol, and substances in the blood that indicate inflammation of the          vessels.        2. Ultrasonography - an ultrasound probe will be applied gently on the neck to image the          right and left carotid arteries (arteries in the neck that lead to the brain). During          the procedure, the heart's electrical activity will also be monitored with an          electrocardiogram and a blood pressure cuff will be wrapped around the arm to obtain          blood pressure measurements every 5 minutes.        3. Magnetic resonance imaging (MRI) - Images of the carotid arteries are taken while the          volunteer lies on a table in a narrow cylinder containing a magnetic field. A padded          sensor called an MRI coil is placed over the neck and earplugs are placed in the ears to          muffle the loud noise of the machine during scanning. During the second half of the          exam, gadolinium is injected through a catheter (thin, flexible tube) inserted into a          vein. Gadolinium is a contrast agent that is used to brighten the scan images.      Information from this study will increase knowledge about the effects of estrogen on vessel     wall inflammation. As such, it may be used in the future to help guide decisions about     chronic hormone replacement therapy in postmenopausal women.   "
165307|NCT00005110|"     Long term use of bronchodilators in CF is beneficial to the improvement of pulmonary function     and symptoms. This study is investigating the long-term benefit of administration of the drug     Salmeterol, a bronchodilator. Salmeterol will be compared to albuterol or placebo. The     medication will be inhaled twice a day for 6 months.   "
165308|NCT00005111|"     This study will determine the rate of sugar metabolism in the brain of patients with Fabry     disease, a genetic disease of abnormal lipid metabolism. Compared with healthy people,     patients with Fabry disease have increased blood flow to the brain, which may result from     abnormal brain metabolic activity. This study will use positron emission tomography (PET) and     magnetic resonance imaging (MRI) to compare brain sugar metabolism in eight untreated     patients, eight patients who are receiving enzyme replacement therapy, and eight healthy     volunteers.      Patients with treated and untreated Fabry disease and normal volunteers may be eligible for     this study. Participants will undergo the following two procedures:        1. PET scan < The patient lies in the PET scanning machine. First, the chest is scanned for          a few minutes to determine how much radiation the tissues of the chest absorb. A          radioactive sugar called fluorodeoxyglucose (FDG) is then injected through a catheter          (thin plastic tube placed in a vein) and the heart is scanned for about 45 minutes to          measure the amount of FDG in the blood inside the heart. The head is then scanned for          about 20 minutes to measure FDG in the brain. This measurement tells how much sugar the          brain uses for energy. The procedure requires insertion of two or three catheters. A          special facemask may be molded to the patient's head to help hold the head still during          the scanning.        2. MRI scan < The patient lies on a table surrounded by the scanner (a metal cylinder) for          about 60 minutes. A strong magnetic field and radio waves are used to show images of          structural and chemical changes in tissues.      This study may provide information that will help explain abnormalities in Fabry disease and     the effect of treatment on the brain.   "
165323|NCT00005128|"     To conduct epidemiologic surveys of the distribution, causes, and consequences of the     dyslipoproteinemias. The Population Studies include the Prevalence Study, the Family Study,     and the Mortality Follow-up Study and shared the same general population base.   "
165324|NCT00005129|"     To determine the natural history of atherosclerosis, coronary artery disease, and     hypertension in children and adults from birth through mid-life in a total biracial     community.   "
165325|NCT00005130|"     To measure changes in coronary heart disease risk factors in cohorts of Black and white males     and females 18 to 30 years of age at baseline. Also, to identify life styles during this age     span which influence these changes in risk factors.   "
165370|NCT00005175|"     To evaluate the relation between blood pressure and socioeconomic status, electrolyte intake,     obesity and psychosocial factors in Black and white students. Also, to compare blood     pressure, cardiovascular risk factors, sodium and potassium excretion in United States Blacks     with West African Blacks.   "
165309|NCT00005112|"     Cystic Fibrosis (CF) is the most common lethal genetic disorder in America. Previous studies     by our group and others have shown that human recombinant growth hormone (GH) improves height     velocity, weight velocity, lean body mass (LBM) and pulmonary function. These positive     results have prompted us to ask further questions regarding GH use in CF including: a) Do     patients with better baseline body weight and pulmonary function derive more benefit from     treatment than those with worse weight and pulmonary function?, b) Does GH use improve the     patient's quality of life?, c) Once GH is discontinued, are the positive effects sustained?     We hypothesize that GH treatment in CF patients will improve their clinical status and their     quality of life. We further hypothesize that these effects will be present regardless of     baseline body weight or pulmonary function, and that positive outcome will be sustained for     at least one year after GH treatment is discontinued. To test our hypothesis, we will recruit     40 prepubertal children from five CF centers across the United States (8 per center).     Patients will be randomly assigned to receive treatment with GH (0.3mg/kg/wk) during either     the first or the second year. All subjects will be seen every three months. We will evaluate     the following parameters every three months: 1) height, height velocity and Z-score, 2) body     weight and weight velocity. Every six months we will measure: 1) lean body mass utilizing     DEXA, 2) pulmonary function, including measurement of respiratory muscle strength (peak     inspiratory and peak expiratory pressure), 3) quality of life (QOL), quantitated from QOL     forms specific for CF (The Cystic Fibrosis Questionnaire). After one year of study,     subjects will cross-over to the other treatment arm. This 24 month study will allow us to     statistically compare outcome measures in 20 treated and 20 nontreated subjects from multiple     centers, and will allow us to assess sustained effect in the 20 subjects who receive GH     during the first year, by comparing their results to results obtained during the year post     treatment.   "
165310|NCT00005113|"     The purpose of this study is to compare treatment with the new drug sirolimus (SRL) versus     the standard treatment with cyclosporine (CsA) or tacrolimus in children who have received     kidney transplants. SRL is a new medication that may prevent the body's immune system from     rejecting organ transplants.      After receiving a kidney transplant, the body recognizes the donated kidney as a foreign     invader and triggers the immune system to attack the kidney. This can lead to rejection of     the new kidney and a failed transplant. To help reduce the risk of kidney rejection,     transplant patients are given immunosuppressant drugs, which reduce the body's normal immune     response and allow the transplanted organ to function. CsA or tacrolimus are two drugs that     are often given to transplant patients. However, these are powerful drugs, and it can cause     serious side effects and put a patient at increased risk for infections. SRL is a new drug     that has been shown to reduce a transplant patient's chance of rejecting a new kidney,     without serious side effects. This study is necessary to test the safety and effectiveness of     SRL in children.   "
165311|NCT00005116|"     Depression is one of the most common emotional problems among youths with insulin dependent     diabetes mellitus (IDDM). It has been shown that depression in youths with IDDM lasts a while     and may have a role in later complications of the medical condition. And yet, there are no     psychological interventions appropriate for such youngsters. The purpose of this study is to     modify a treatment called ''Contextual Psychotherapy'' (that has been developed for depressed     youngsters) in order to address special needs of depressed youths with IDDM, and to ''pilot     test'' the treatment. The youngsters to be recruited are those being cared for at the     Diabetes Clinic of the Children's Hospital of Pittsburgh. The treatment includes a 3- month     phase (16 sessions), followed by a 3-month ''booster'' phase (3 sessions), and two later     follow-up evaluations.   "
165312|NCT00005117|"     There is significant evidence that HMG-CoA reductase inhibitors, a commonly used class of     cholesterol lowering medications, reduce the risk of death from coronary disease. Although     these medicines lower cholesterol levels, other studies suggest that they have an additional     effect on improving blood vessel functioning. It has also been shown that consumption of a     fatty meal temporarily alters blood vessel functioning, causing endothelial dysfunction. This     study will examine if pravastatin, an HMG-CoA reductase inhibitor, improves blood vessel     functioning after a fatty meal. We plan on enrolling 32 subjects, aged 18-40 years, who are     healthy with no history of diabetes, smoking, high blood pressure, or heart disease. These     subjects will be randomly assigned to initially receive four days of pravastatin or an     inactive substance, and then crossed over to the other group. Blood vessel functioning will     be monitored by a technique called flow mediated vasoactivity, which uses ultrasound     measurement of the forearm artery and its response to temporary occlusion. This primary     measure of flow mediated vasoactivity will be done before and after consumption of a fatty     meal. We hope to show that treatment with pravastatin prevents the blood vessel dysfunction     known to occur after a high fat meal. Secondary outcomes will include measurement of     endothelin-l, a mediator of blood vessel functioning, and assessment of changes in lipid     profiles. If pravastatin does prevent endothelial dysfunction in this setting, it could lead     to further studies about their use in more acute medical settings, including heart attacks or     strokes.   "
165313|NCT00005118|"     The purpose of this study is to see if it is safe and effective to give indinavir plus     ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.   "
165314|NCT00005119|"     Osteoporosis has become one of the most widely recognized disorders of our times affecting an     estimated 25 million women in this country. Recent evidence has suggested that premenstrual     syndrome (PMS) is associated with a calcium deficiency state and bone loss. This may place     premenopausal women at greater risk for osteoporosis. An entity such as PMS may be an     important physiological marker of a calcium disturbance. The purpose of this investigation is     to understand more completely the extent to which calcium balance is disturbed in severe PMS     or Premenstrual Dysphoric Disorder (PMDD) by utilizing new tools to assess calcium and bone     turnover. The long term objective is to elucidate the pathophysiology of PMDD or severe PMS     as it relates to calcium hormones and bone markers. The experimental design involves the     comparison between women witn severe PMS and asymptomatic controls.   "
165315|NCT00005120|"     The purpose of this study is to see if it is safe and effective to give calanolide A to     HIV-infected adults who have not used anti-HIV drugs in the past.   "
165316|NCT00005121|"     The Framingham Heart Study was initiated to study the factors associated with the development     of cardiovascular disease by employing long-term surveillance of an adult population in     Framingham, Massachusetts. The Framingham Offspring Study was initiated to assess familial     and genetic factors as determinants of coronary heart disease.   "
165317|NCT00005122|"     To conduct surveillance of cardiovascular morbidity and mortality and its correlation with     known risk factors in all cohort study groups in Evans County, Georgia.   "
165318|NCT00005123|"     To investigate coronary heart disease and stroke among American men of Japanese ancestry who     were living on the island of Oahu in 1965. Morbidity and mortality surveillance of the     original cohort is continuing.   "
165319|NCT00005124|"     To assess genetic effects on the variation of cardiovascular and pulmonary risk factors in a     cohort of 514 pairs of white male veteran twins.   "
165326|NCT00005131|"     To measure associations of established and suspected coronary heart disease risk factors with     both atherosclerosis and new coronary heart disease events in representative cohorts from     four diverse United States communities. To compare the communities with respect to risk     factors, medical care, atherosclerosis, and coronary heart disease incidence. ARIC has two     components in each community: study of representative cohorts of adult men and women, and     community surveillance of morbidity and mortality.   "
165327|NCT00005132|"     To determine if the Black-white differences in the development of obesity in pubescent     females were due to differences in psychosocial, socioeconomic and other environmental     factors. Also, to determine whether differences in the development of obesity led to     Black-white differences in other coronary heart disease risk factors, such as blood pressure     and serum lipids.   "
165328|NCT00005133|"     To determine the extent to which known risk factors predict coronary heart disease and stroke     in the elderly, to assess the precipitants of coronary heart disease and stroke in the     elderly, and to identify the predictors of mortality and functional impairments in clinical     coronary disease or stroke.   "
165329|NCT00005134|"     To determine morbidity and mortality from cardiovascular disease among American Indians and     to compare cardiovascular disease risk factor levels among Indian groups living in different     geographic areas.   "
165330|NCT00005135|"     To conduct a multicenter study of the relationship between insulin resistance and     cardiovascular disease (CVD) and its risk factors in a tri-ethnic (African-American,     Hispanic, and non-Hispanic white) population aged 40 to 69 years at baseline. Also, to     identify the genetic determinants of insulin resistance and visceral adiposity.   "
165331|NCT00005136|"     To identify and evaluate genetic and non-genetic determinants of coronary heart disease     (CHD), atherosclerosis, and their risk factors in ongoing population-based epidemiology     studies. The multicenter study was conducted in three phases which were: Phase I, the family     history component: Phase II, the clinical examination and follow-up component; and Phase III,     the molecular genetic and genetic epidemiology studies component.   "
165332|NCT00005137|"     To document the role of the genotype in the cardiovascular and metabolic responses to aerobic     exercise-training and the contribution of inherited factors in the changes brought about by     regular exercise for several cardiovascular disease and diabetes risk factors. A consortium     of laboratories from five institutions in the United States and Canada are carrying out this     study.   "
165333|NCT00005138|"     To continue a longitudinal study of blood pressure and blood pressure correlates in a     population of 1,140 young adults, first seen in 1973 as adolescents, aged 14-19 years.   "
165334|NCT00005139|"     To determine the genetics and epidemiology of different types of early familial coronary     disease. Accurate markers of major gene syndromes for early coronary disease were identified     using a genetic segregation and linkage study of lipids, lipoproteins, apolipoproteins, and     DNA probes in 36 large Utah pedigrees.   "
165335|NCT00005140|"     To continue the comprehensive research program on the epidemiology of cardiovascular and     other major chronic diseases, including cancer and diabetes, in four Chicago population     cohorts. The four cohorts include the Chicago Heart Association Detection Project in Industry     cohort, the Peoples Gas Company cohort first examined in 1958-1959, the Peoples Gas Company     cohort first examined in 1959-1962, and the Western Electric Company cohort.   "
165336|NCT00005141|"     To examine environmental and familial correlates of childhood blood pressure in order to     predict elevated blood pressure in young adulthood. Also, to investigate the phenomena of     tracking of blood pressure and obesity from childhood to young adulthood.   "
165337|NCT00005142|"     To determine the prevalence of peripheral arterial disease in a defined population by     non-invasive techniques; to evaluate the association of cardiovascular disease risk factors     with peripheral vascular disease; to determine whether non-invasive tests of peripheral     arterial disease can be utilized as markers for coronary heart disease; to determine the     status of the microvasculature using conjunctival photographs and to compare the results with     risk factors and the peripheral arterial disease testing results.   "
165338|NCT00005143|"     To conduct a large-scale demonstration and education project designed to evaluate the     feasibility and effectiveness of long-term community health education directed toward     lowering cardiovascular disease risk, morbidity, and mortality. Targeted risk factors     included general lifestyle, smoking, blood pressure, nutrition and weight, and exercise. The     program was evaluated by biennial cross-sectional independent surveys, longitudinal studies,     and morbidity and mortality surveillance.   "
165339|NCT00005144|"     To further clarify the concept of coronary-prone behavior and to develop methods of assessing     coronary-prone behavior. Specifically, to revise the component scoring system for Potential     for Hostility in the Structured Interviews measure of Type A behavior.   "
165340|NCT00005145|"     To continue surveillance of cardiovascular disease risk factors in the seven-county area of     Minneapolis-St. Paul.   "
165341|NCT00005146|"     To determine factors beyond obesity which contribute to diabetes and cardiovascular risk in     Mexicans and Mexican Americans. To test the hypothesis that at any given level of adiposity     Mexican Americans will be more insulin resistant than Anglos and that the insulin resistance     in Mexican Americans is proportional to the degree of Native American ancestry.   "
165342|NCT00005147|"     To determine the role of genetic factors in predicting resistance and susceptibility to     coronary artery disease.   "
165343|NCT00005148|"     To determine the incidence, secular trends, and outcomes of coronary heart disease in the     population of Rochester, Minnesota.   "
165344|NCT00005149|"     To determine the pathophysiology of different types of essential hypertension by identifying     the discrete effects of major genes and environmental variables as determinants of the     subtypes of essential hypertension.   "
165345|NCT00005150|"     To conduct a large-scale community-based demonstration and education research project     designed to evaluate the effectiveness of multiple educational strategies on risk factor     reduction and the primary prevention of population-wide cardiovascular diseases in three     intervention communities compared with three control communities. The program was evaluated     by cross-sectional surveys, a longitudinal survey, and morbidity and mortality surveillance.   "
176561|NCT00155532|"     To address the issues of skin denervation and its clinical and pathological correlations in     systemic lupus erythematosus   "
165346|NCT00005151|"     To conduct a community-based research and demonstration project in cardiovascular disease     prevention in the town of Pawtucket, Rhode Island. Targeted risk factors included high blood     pressure, elevated blood cholesterol, obesity, cigarette smoking, and sedentary living. To     evaluate the program, risk factor surveys on a cross-sectional and cohort basis were     conducted along with mortality and morbidity surveillance both in Pawtucket and in the     non-intervention comparison town of New Bedford, Massachusetts.   "
165347|NCT00005152|"     To determine the relationships of hormonal factors, a variety of nutrients, diabetes,     exercise, and brand of cigarettes smoked with the subsequent risk of coronary heart disease,     pulmonary embolism, and stroke in a cohort of female registered nurses.   "
165348|NCT00005153|"     To identify genetic and environmental risk factors for congenital cardiac disease.   "
165349|NCT00005154|"     To supplement the fourth National Health and Nutrition Examination Survey protocol to include     data on the common heart, vascular, lung, and blood diseases.   "
165350|NCT00005155|"     To test the physiological and psychosocial correlates of Type A behavior.   "
165351|NCT00005156|"     To ascertain the sixteen year mortality status of the 361,662 middle-aged men screened in     1973-1975 for the Multiple Risk Factor Intervention Trial (MRFIT).   "
165352|NCT00005157|"     To improve the predictive validity of Structured Interview assessments of Type A behavior by     comparing interviewer techniques in the Multiple Risk Factor Intervention Trial (MRFIT) and     the Western Collaborative Group Study (WCGS). To assess whether there were interviewer     differences in the predictiveness of Type A behavior and its components for coronary heart     disease incidence in MRFIT and WCGS and if so, to assess whether the interviewer differences     in disease predictiveness were related to interviewer stylistics.   "
165353|NCT00005158|"     To determine the genetic components of hypertension using a series of simulation experiments     designed to determine the power and validity of the then recently developed methods of     segregation and linkage analysis.   "
165354|NCT00005159|"     To estimate probabilities of death by cause for a representative United States population,     according to age, sex, race, occupation, industry, income, education, residence, country of     birth, calendar year, and a number of other demographic and epidemiologic factors. The     representative population is derived from selected Bureau of the Census files and is matched     to the National Death Index maintained by the National Center for Health Statistics. The     Bureau of the Census provides the data processing, coding and management necessary to     complete this objective.   "
165355|NCT00005160|"     To determine cardiovascular risk factors and the change in risk factors during and following     the menopause.   "
165356|NCT00005161|"     To analyze the genetic and environmental contributions of juvenile hemodynamic determinants     of blood pressure, including cardiac output and systemic vascular pressure, to adult     cardiovascular risk.   "
165357|NCT00005162|"     To continue a study of premature coronary heart disease mortality among men and women aged     35-54 in Allegheny County, Pennsylvania.   "
165358|NCT00005163|"     To field test the validity, reliability, cost, and cost-benefit of Health Risk Appraisal     (HRA) instruments.   "
165359|NCT00005164|"     To determine the role of insulin resistance in peripheral vascular dynamics, sodium     sensitivity, and blood pressure regulation in a young representative Black population and in     a group of young Blacks at high risk for hypertension.   "
165360|NCT00005165|"     To examine the role of isolated systolic hypertension and other predictors of all-cause and     coronary heart disease mortality in elderly Blacks and whites of the Charleston Heart Study     cohort of 1960 and to compare and pool those findings with the Evans County Heart Study     findings in order to develop a logistic risk function for Blacks. Also, to identify     predictors of physical functioning in older Blacks and whites and to prepare rosters of the     off-spring of the Charleston cohort for future studies of genetic/familial influences on     cardiovascular disease.   "
165361|NCT00005166|"     Originally, to determine whether genetic alterations in pathways of sodium ion transport in     the red blood cells of children could predict their risk of developing primary hypertension     in adulthood. In 1992, the objective was to determine the genetic basis of interindividual     variation in the risk of essential hypertension in the population at large using the     Rochester Family Heart Study.   "
165362|NCT00005167|"     To determine the effects of diet modification on blood pressure, blood cholesterol, and bone     density in healthy young people.   "
165363|NCT00005168|"     To determine the role of apolipoprotein B and apolipoprotein A1 in the etiology of coronary     artery disease.   "
165364|NCT00005169|"     To monitor the relationship of lifestyle variables, particularly exercise, to cardiovascular     mortality, all-cause mortality, projected longevity and aging, and cardiovascular morbidity     in a large cohort of college graduates. To assess changing patterns of exercise, cigarette     smoking, body weight, and blood pressure between the 1960s and 1990s for relationship to     cardiovascular morbidity and mortality.   "
165365|NCT00005170|"     To determine ways in which behavioral factors influenced the diagnosis and development of     hypertension in adult working populations.   "
165366|NCT00005171|"     To describe secular trends in cardiovascular risk factors in the adolescent and adult United     States population and to identify and quantify the changes in variables related to these risk     factors. Also, to modify and implement the statistical methodology available for the analysis     of complex sample survey data in order to model and test these secular trends across separate     nationally representative databases. The differences in risk factors in these samples were     contrasted with those from a special population group, Hispanic Americans.   "
165367|NCT00005172|"     To investigate psychosocial and dietary influences on blood pressure in Blacks.   "
165368|NCT00005173|"     To evaluate whether the long-term use of oral contraceptives, after discontinuation, was     associated with an increased incidence of first nonfatal myocardial infarction among women     above the age of 50.   "
165369|NCT00005174|"     To conduct a 25-year follow-up of the surviving participants in the Western Collaborative     Group Study, the first large prospective study of coronary heart disease risk factors to     incorporate direct assessment of Type A behavior.   "
176708|NCT00147966|"     Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers     will assess changes in the immune response that occur as a result of treatment with     rituximab.   "
165373|NCT00005178|"     In the first study, to identify children at high and low risk for cardiovascular disease and     study their nutritional and physical activity behaviors as they relate to cardiovascular     disease. In the second study, to make yearly assessments over a four year period of diet and     physical activity among children and their parents. The initial effort redefined and retested     methods to collect data on dietary intake and activity levels of young children.   "
165374|NCT00005179|"     To document the patterns of influence or socialization from parents to children in regard to     the transmission of cardiovascular disease risk related behaviors such as diet and physical     activity.   "
165375|NCT00005180|"     To determine the distribution of left ventricular hypertrophy and retinal vascular     abnormalities in children and adolescents with essential hypertension; to evaluate potential     risk factors and the time sequence for the development of these end-organ complications in     this population.   "
165376|NCT00005181|"     To correlate dietary factors and changes in pressor substances, including aldosterone and     norepinephrine, with blood pressure during growth and sexual development from childhood     through adolescence.   "
165377|NCT00005182|"     To test the hypothesis that increased risk of coronary heart disease, stroke, peripheral     vascular disease, and cancer is related to diets high in saturated fat, animal protein, and     hydrogenated vegetable oil, and low in polyunsaturated fat, fiber, vitamins A, C, and E,     calcium, selenium, and chromium.   "
165378|NCT00005183|"     To further define the linkage of the Apo A-I gene polymorphism to genetic high density     lipoprotein (HDL) deficiency and premature coronary artery disease. Also, to utilize this     gene marker to define the prevalence of genetic HDL deficiency in patients with premature     coronary disease and to determine the relative risk of premature coronary disease associated     with the Apo A-I gene polymorphism.   "
165379|NCT00005184|"     To assess the association of immunogenetic factors with onset of coronary heart disease and     the interrelationship of these factors with standard coronary heart disease risk factors.   "
165380|NCT00005185|"     To evaluate whether the use of noncontraceptive estrogen influenced the incidence of first     myocardial infarction in women.   "
165381|NCT00005186|"     To identify and describe the distribution of risk factors for cardiovascular disease in a     cohort of free-living elderly persons.   "
165382|NCT00005187|"     To characterize the epidemiology and genetics of apolipoproteins A-I, A-II, B, C-II, C-III,     and E in a population of Mexican-Americans in Starr County, Texas.   "
165383|NCT00005188|"     To assess the mode of inheritance of familial combined hyperlipidemia and familial primary     hypoalphalipoproteinemia and to resolve genetic and familial environmental effects on several     phenotypes of importance to coronary heart disease.   "
165384|NCT00005189|"     To determine whether the degree of carotid artery atherosclerosis, as measured by B-mode     ultrasound, predicts the development of myocardial infarction, stroke, and all-cause     mortality in patients with angiographically defined coronary status. Also, to quantify the     rate of progression of carotid artery disease and to evaluate the risk factors associated     with progression of carotid atherosclerosis.   "
165385|NCT00005190|"     To create a registry of all Oregon children undergoing surgical repair of congenital heart     disease since 1958 in order to determine mortality, morbidity, and disability after surgery     and to assess the safety of pregnancy in women with corrected congenital heart disease and     the risk of prematurity and occurrence of congenital heart defects in offspring.   "
165386|NCT00005191|"     To determine the clinical course of coronary artery disease among Blacks receiving medical     care for symptomatic heart diseases.   "
165387|NCT00005192|"     To determine why Black Americans have a higher prevalence of hypertension than whites by     examining the interactions of psychosocial stressors and suppressed hostility with genetic or     constitutional factors.   "
165388|NCT00005193|"     To study the relationship between diabetes and various macro- and microvascular complications     in Oklahoma Indians.   "
165389|NCT00005194|"     To determine the role played by insulin and biogenic amines in obesity-related hypertension     and cardiovascular disease.   "
165390|NCT00005195|"     To assess factors associated with safety and efficacy of catheter ablation using direct     current or radiofrequency energy for the management of patients with drug and/or pacemaker     resistant cardiac arrhythmias.   "
165391|NCT00005196|"     To examine time trends in the incidence rates of acute myocardial infarction and     out-of-hospital coronary heart disease deaths as well as changes in the in-hospital and     long-term case-fatality rates of acute myocardial infarction in the Worcester, Massachusetts     Standard Metropolitan Statistical Area (SMSA).   "
165392|NCT00005197|"     To determine the predictors of perioperative cardiac morbidity and mortality in patients at     high risk who underwent major noncardiac surgery with general anesthesia.   "
165393|NCT00005198|"     To determine the natural history of coronary heart disease in the biethnic community of     Corpus Christi, Texas.   "
165394|NCT00005199|"     To establish a registry in order to collect and analyze baseline and outcome data on patients     with severe valvular stenosis treated with balloon valvuloplasty.   "
165395|NCT00005200|"     To evaluate possible early neurogenic influence in essential hypertension by monitoring heart     growth in adolescents over a two year interval.   "
165396|NCT00005201|"     To determine the familial occurrence and pathogenesis of idiopathic dilated cardiomyopathy.   "
165397|NCT00005202|"     To validate two models which categorized patients with syncope into high and low risk for     either sudden death or diagnostic arrhythmias based on data available from the initial     history, physical examination, and electrocardiogram.   "
165398|NCT00005203|"     To perform genetic studies of low density lipoprotein (LDL) subclasses in 160 families in     whom the probands had metabolically defined hypercholesterolemia.   "
176709|NCT00147979|"     Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale:     PTFE with or without bounded heparin   "
165470|NCT00005981|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have metastatic colorectal cancer.   "
165399|NCT00005204|"     To determine if hypertensives and normotensives of similar ages had, on average, different     ratios of 24-hour to overnight excretion of sodium, potassium, and water. Also, to determine     the number of 24-hour collections needed to characterize individuals with respect to the     ratios of 24-hour to overnight excretion and to determine if the ratios of 24-hour to     overnight excretion vary by age and other factors related to blood pressure.   "
165400|NCT00005205|"     To determine the incidence of type II diabetes and cardiovascular disease among     Mexican-American and non-Hispanic whites in a 15 to 24 year follow-up of the San Antonio     Heart Study 1 participants. Also, to perform a 15 to 24 year mortality follow-up of the     cohort and to examine the Hispanic paradox.   "
165401|NCT00005206|"     To determine if low dietary calcium intake and disturbances in maternal calcium metabolism     were associated with increases in blood pressure in late pregnancy.   "
165402|NCT00005207|"     To determine the role of the prorenin-renin-angiotensin-aldosterone system (RAAS) in normal     and hypertensive pregnancy.   "
165403|NCT00005208|"     To elucidate the role of an imbalance in vasodilator prostacyclin (PGI2) and vasoconstrictor     thromboxane (TxA2) in pregnancy-induced hypertension   "
165404|NCT00005209|"     To relate observations at the DNA level to the distribution of coronary heart disease in the     population at large.   "
165405|NCT00005210|"     To prospectively explore the relationships of endogenous sex steroid hormones and obesity and     their interactions with lipoprotein cholesterol and apolipoprotein levels in nine and ten     year old Black and white adolescent girls for five years during puberty.   "
165406|NCT00005211|"     To assess the risk of cardiovascular mortality in workers with increased occupational     exposure to carbon monoxide.   "
165407|NCT00005212|"     To determine the combined effects of job strain and social isolation on cardiovascular     morbidity and mortality.   "
165408|NCT00005213|"     To conduct ancillary studies of sodium-stimulated lithium counter-transport in the Chicago     components of the Coronary Heart Disease Risk Development in Young Adults (CARDIA) cohort and     in the Treatment of Mild Hypertension Study (TOMHS) cohort.   "
165409|NCT00005214|"     To investigate the genetics and epidemiology of fasting and postprandial lipid, lipoprotein,     and apolipoprotein levels.   "
165410|NCT00005215|"     To determine the relationship of fatal and nonfatal coronary heart disease to lipoprotein     fractions and other risk factors in a prospective epidemiologic study conducted between 1954     and 1957.   "
165411|NCT00005216|"     To determine if silent myocardial ischemia was associated with an increased risk of cardiac     mortality and morbidity during a one to three year follow-up in patients with coronary heart     disease.   "
165412|NCT00005217|"     To determine if intermittent ST depression (STD) had an independent impact on survival among     myocardial infarction patients who participated in the Beta-Blocker Heart Attack Trial     (BHAT).   "
165413|NCT00005218|"     To develop a prototype questionnaire for the detection of angina pectoris in Blacks.   "
165414|NCT00005219|"     To conduct a two-year follow up of participants in a cross-sectional study of physical     activity determinants. Predictors of change in vigorous exercise habits and recreational     walking habits were identified as were determinants of change in the proportion of the sample     who initiated, maintained, or discontinued exercise.   "
165415|NCT00005220|"     To evaluate the cardiovascular effects of postmenopausal hormone replacement therapy and the     suspected beneficial effects on myocardial infarction and stroke.   "
165416|NCT00005221|"     To define new national norms for pediatric blood pressure by adjusting the available data set     of over 60,000 pediatric blood pressure readings for age, height and gender among children of     normal body weight.   "
165417|NCT00005222|"     To investigate possible mechanisms responsible for the decline in cardiovascular disease     mortality among the Framingham Heart Study population and to evaluate the health status of     survivors in terms of subsequent illness and functional limitations.   "
165418|NCT00005223|"     To examine the complex interactions among the traditional cardiovascular risk factors,     particularly lipoprotein and apoprotein levels, genetic and other characteristics, and     lifestyle habits in elderly women.   "
165419|NCT00005224|"     To examine sex differences in behavioral and psychosocial variables such as occupation, Type     A behavior, and hostility as they related to primary coronary risk factors.   "
165420|NCT00005225|"     To determine the relative risk in a defined population of angiographically demonstrated     coronary artery disease due to genetic polymorphisms at the four apolipoprotein genomic     regions.   "
165421|NCT00005226|"     To measure by gas-liquid chromatography the relative concentrations of all saturated and     unsaturated fatty acids found in the cholesterol ester and phospholipid fractions of plasma     from 4,000 subjects participating in the Atherosclerosis Risk in Communities (ARIC) study.     The data were used to clarify the role of various fatty acids in atherosclerosis.   "
165422|NCT00005227|"     To define the incidence and prevalence of AIDS-associated cardiomyopathy. Also, to conduct     immunopathology and serologic studies in endomyocardial biopsies and autopsy tissues.   "
165423|NCT00005228|"     To detect by Doppler echocardiography the incidence of cardiac abnormalities in HIV-positive     patients in a prospective, longitudinal study.   "
165424|NCT00005229|"     To develop natural history data regarding the incidence, clinical course, prognosis, and     effects of treatment with anti-viral and immunosuppressive agents on HIV-associated heart     disease. A second part of the study evaluated a number of possible mechanisms underlying the     development of HIV heart disease.   "
165425|NCT00005230|"     To determine whether a population with isolated systolic hypertension (ISH) had a higher     prevalence of carotid disease than a normotensive population matched for age and sex, and to     determine specific risk factors for carotid disease.   "
165426|NCT00005231|"     To develop a comprehensive protocol for assessing cardiovascular reactivity to stressors, for     use in epidemiological and clinical investigations of cardiovascular diseases in healthy     populations.   "
165427|NCT00005232|"     To conduct a five-year follow-up of the population of Gubbio, a town in north central Italy,     in order to determine the relationship of baseline sodium-stimulated lithium countertransport     to subsequent change in blood pressure and incidence of hypertension.   "
165428|NCT00005233|"     To study the absolute concentrations and percent of fatty acids in 480 plasma samples from an     age and sex stratified random sample of subjects in the Framingham Offspring Study in order     to calculate the distribution of fatty acids in this general population and to determine the     inter-relationships among levels of fatty acids, in particular w3 and w6 fatty acids, with     lipoproteins and apolipoproteins.   "
165429|NCT00005234|"     To examine the natural histories of coronary artery disease and hypertension in cohorts of     Black and white men of identical education and occupations.   "
165430|NCT00005235|"     To evaluate the ability of heart rate variability to identify myocardial infarction patients     at high risk of dying, particularly from sudden cardiac death.   "
165431|NCT00005236|"     To determine whether there were differences in the prevalence and extent of atherosclerotic     lesions in the coronaries and aortas between Alaskan natives and non-natives, and whether the     extent of the lesions was related to omega-3 fatty acids in blood and tissues.   "
165432|NCT00005237|"     To acquire a better understanding of the spontaneous clinical behavior of paroxysmal     tachycardia by studying epidemiologic features of symptomatic tachycardia patients.   "
165433|NCT00005238|"     To determine the role of environmental stressors in the development of hypertension in Black     and white school-age children from hypertensive families.   "
165434|NCT00005239|"     To examine genetic and environmental influences on several recently identified coronary heart     disease risk factors in identical and fraternal adult women twins. The risk factors included     low density lipoprotein (LDL) subclass patterns, plasma apolipoprotein levels, body fat     distribution, and serum insulin levels.   "
165435|NCT00005240|"     To test the hypotheses that hypertensive emergency was associated with non-compliance with     antihypertensive medication, low level of contact with the medical care system, and alcohol     abuse and cigarette smoking. Also, to describe the clinical characteristics of patients     hospitalized with hypertensive emergency including morbidity, mortality, and cost, and the     extent to which hypertensive emergency occured among previously diagnosed and treated     hypertensives.   "
165436|NCT00005241|"     To assess whether current oral contraceptive (OC) use (within the previous month) increased     the risk of myocardial infarction. Also, to assess the combined effects of cigarette smoking     and oral contraceptive use.   "
165437|NCT00005242|"     To determine the effects of long-term exposure to passive smoking on the cardiovascular and     oxygen transport systems in pre-adolescent twins.   "
165438|NCT00005243|"     To investigate factors which trigger the discharge of implantable cardioverter-defibrillators     (ICDs).   "
165439|NCT00005244|"     To identify behavioral factors underlying the development of cardiovascular risk in young     adults.   "
165440|NCT00005245|"     To assess the relationship of community socioeconomic (SE) structure to cardiovascular     disease and all-cause mortality trends in the United States.   "
165441|NCT00005246|"     To determine whether serum insulin is a risk factor for coronary heart disease morbidity and     mortality and whether dehydroepiandrosterone sulfate (DHEAS) is a risk factor for coronary     heart disease mortality. Also, to ascertain the determinants of serum insulin levels among     middle-aged men.   "
165442|NCT00005247|"     To define the role of nutritional and dietary variables in determining atherogenic traits and     morbidity and mortality due to coronary heart disease as observed in the Framingham Heart     Study cohort and the Framingham Offspring Study cohort.   "
165443|NCT00005248|"     To examine the relationships of obesity and fat patterning with morbidity and mortality in     Black Americans.   "
165444|NCT00005249|"     To determine the roles of insulin, lipids, body weight and ion transport in blood pressure     regulation.   "
165445|NCT00005250|"     To screen by electrocardiography the entire population of 1,400 individuals in seven Amish     Mennonite communities in order to perform genetic linkage studies of long QT syndrome (LQTS).   "
165446|NCT00005251|"     To map the genetic defect responsible for familial hypertrophic cardiomyopathy.   "
165447|NCT00005252|"     To explain the extremely low cardiovascular mortality among Physicians' Health Study (PHS)     participants by ascertaining all cardiovascular and total deaths among the 90,457 physicians     who returned enrollment forms but were not randomized into the study. Also, to compare the     mortality experience of randomized physicians with various subgroups of non-participants.   "
165448|NCT00005253|"     To determine whether treatment with antidepressant, anticonvulsant, and antiarrhythmic drug     therapies having the potential for proarrhythmia increased the risk of primary cardiac     arrest. The aim of the original grant, starting in 1990 and ending in 1994, was to determine     whether use of diuretics for hypertension increased the risk of primary cardiac arrest     compared to the use of other antihypertensive agents.   "
165449|NCT00005254|"     The Veterans Administration Patient Study examined the progression of peripheral arterial     disease (PAD) in patients with large vessel PAD or isolated small vessel PAD. The Community     Follow-up Study following subjects with and without PAD from a previous cohort to determine     subsequent coronary heart disease and cardiovascular disease morbidity and mortality.   "
165450|NCT00005961|"     Phase II trial to study the effectiveness of O6-benzylguanine and carmustine in treating     patients who have unresectable locally recurrent or metastatic melanoma. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than once chemotherapy drug may kill more tumor cells.   "
165451|NCT00005962|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate     cancer cells and either kill them or deliver cancer-killing substances to them without     harming normal cells. Combining more than one drug or combining monoclonal antibody with     chemotherapy may kill more cancer cells. It is not yet known which treatment regimen is more     effective for acute myelogenous leukemia.      PURPOSE: Randomized phase II trial to compare the effectiveness of three treatment regimens     in treating patients who have relapsed or refractory acute myelogenous leukemia.   "
165452|NCT00005963|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in     treating women who have metastatic breast cancer.   "
165453|NCT00005964|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor     cells. It is not yet known which combination chemotherapy regimen is most effective in     treating aggressive non-Hodgkin's lymphoma.      PURPOSE: Randomized phase II trial to compare the effectiveness of two combination     chemotherapy regimens in treating patients who have previously untreated aggressive stage II,     stage III, or stage IV non-Hodgkin's lymphoma.   "
165454|NCT00005965|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of bryostatin-1 plus cisplatin in treating     patients who have recurrent or advanced cancer of the cervix.   "
165455|NCT00005966|"     RATIONALE: Interferon alfa-2b may interfere with the growth of the cancer cells. Thalidomide     may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if     interferon alfa-2b is more effective with or without thalidomide in treating kidney cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa-2b with     or without thalidomide in treating patients who have previously untreated metastatic or     unresectable kidney cancer.   "
165456|NCT00005967|"     Randomized phase I trial to study the effectiveness of tipifarnib in treating patients who     have advanced hematologic cancer. Drugs used in chemotherapy use different ways to stop     cancer cells from dividing so they stop growing or die.   "
165457|NCT00005968|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have     stage IV melanoma.   "
165458|NCT00005969|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin in treating     patients who have recurrent or refractory Hodgkin's disease.   "
165459|NCT00005970|"     This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide,     paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy     alone in treating women with breast cancer that is human epidermal growth factor receptor 2     (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the     lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing     so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. It is not yet known whether combination chemotherapy is more effective with or without     trastuzumab in treating breast cancer.   "
165460|NCT00005971|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who     have metastatic malignant melanoma.   "
165461|NCT00005972|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have recurrent or refractory small cell lung cancer.   "
165462|NCT00005973|"     Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid     tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die   "
165463|NCT00005974|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who     have recurrent, locally advanced, or metastatic soft tissue sarcoma.   "
165464|NCT00005975|"     RATIONALE: Megestrol may be effective in treating hot flashes following treatment for breast     cancer. It is not yet known which regimen of megestrol is most effective for hot flashes.      PURPOSE: Randomized phase III trial to compare the effectiveness of different doses of     megestrol in treating hot flashes in patients who have undergone therapy for breast cancer.   "
165465|NCT00005976|"     Phase I/II trial to study the effectiveness of pyrazoloacridine plus carboplatin in treating     patients who have recurrent glioma. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Combining more than one drug may kill     more tumor cells.   "
165466|NCT00005977|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.   "
165467|NCT00005978|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor     cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell     or bone marrow transplantation may be able to replace immune cells that were destroyed by     chemotherapy or radiation therapy.      PURPOSE: This phase I trial is studying the side effects and best dose of combination     chemotherapy when given before stem cell transplant and radiation therapy in treating     patients with neuroblastoma that has not responded to previous treatments.   "
165468|NCT00005979|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known if combination chemotherapy is more effective with or without irinotecan in     treating colon cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without irinotecan in treating patients who have stage III colon cancer.   "
165469|NCT00005980|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more     effective for metastatic breast cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal     doxorubicin in treating women who have metastatic breast cancer.   "
176755|NCT00148577|"     We aimed to establish the reduction of labor pain by applying TENS at acupuncture points     during the first stage of labour, to assess their efficacy, and to ascertain their     acceptability.   "
165472|NCT00005983|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or     without radiation therapy in treating breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy,     and/or hormone therapy with or without radiation therapy in treating women who have stage II     breast cancer.   "
165473|NCT00005984|"     RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem     cells move from the patient's bone marrow to the blood so they can be collected and stored.     Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell     transplant. The stem cells are returned to the patient to replace the blood-forming cells     that were destroyed by the chemotherapy and radiation therapy.      PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed     by stem cell transplant works in treating patients with chronic phase or accelerated phase     chronic myelogenous leukemia.   "
165474|NCT00005985|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.     Colony-stimulating factors such as filgrastim may increase the number of immune cells found     in bone marrow or peripheral blood and may help a person's immune system recover from the     side effects of chemotherapy.      PURPOSE: This phase II trial is studying how well giving filgrastim together with     chemotherapy and peripheral stem cell transplant works in treating patients with Hodgkin's     lymphoma or non-Hodgkin's lymphoma.   "
165475|NCT00005986|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.     Colony-stimulating factors such as filgrastim may increase the number of immune cells found     in bone marrow or peripheral blood and may help a person's immune system recover from the     side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy and filgrastim followed by     peripheral stem cell transplantation in treating patients who have chronic myelogenous     leukemia.   "
165476|NCT00006207|"     The purpose of this study is to determine whether the vaginal gel PRO 2000/5 causes     irritation when used daily.      Studies have shown PRO 2000/5 is safe and well tolerated as a vaginal gel in healthy women     who are not sexually active. However, it was not determined what side effects to skin in the     vaginal area there might be in sexually active women.   "
165477|NCT00006208|"     The purpose of this study is to compare the safety and effectiveness of emtricitabine and     stavudine when given with didanosine plus efavirenz to HIV-infected patients.   "
165478|NCT00006209|"     The purpose of this study is to see if it is safe to give tucaresol to HIV-infected patients     who are taking combination anti-HIV therapy (HAART). This study also examines the effect     tucaresol has on viral load (level of HIV in the body) when tucaresol is used with HAART.   "
165479|NCT00006211|"     The purpose of this study is to see if the addition of capravirine to VIRACEPT (nelfinavir     mesylate) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is an effective     combination drug therapy for HIV patients who have failed a nonnucleoside reverse     transcriptase inhibitor (NNRTI) therapy.   "
165480|NCT00006212|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Drugs such as phosphorus-32 may make the tumor cells more sensitive to radiation therapy.     Chemotherapy combined with radiation therapy and phosphorus-32 may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of phosphorus-32 plus radiation therapy and     chemotherapy in treating patients who have stage II or stage III non-small cell lung cancer.   "
165481|NCT00006213|"     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Phase I trial to study the effectiveness of BMS-214662 in treating patients     who have acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia in blast phase   "
165482|NCT00006214|"     RATIONALE: Chemoprevention therapy is the use of certain drugs such as flutamide to try to     prevent the development of cancer. Flutamide may be effective in the prevention of prostate     cancer.      PURPOSE: Randomized clinical trial to study the effectiveness of flutamide in preventing     prostate cancer in patients who have neoplasia of the prostate.   "
165483|NCT00006215|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.     Colony-stimulating factors such as filgrastim may increase the number of immune cells found     in bone marrow or peripheral blood and may help a person's immune system recover from the     side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     filgrastim in treating patients who have stage IIIB or stage IV non-small cell lung cancer.   "
165484|NCT00006216|"     RATIONALE: Ganciclovir may ease some of the side effects of cancer treatment. Vaccines made     from a person's modified malignant mesothelioma cells may make the cancer more sensitive to     ganciclovir.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus ganciclovir in     treating patients who have stage I, stage II, or stage III malignant mesothelioma.   "
165485|NCT00006218|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of 3-AP in treating patients who have     advanced cancer.   "
168633|NCT00035763|"     To measure the variability in pain and response to pain in sickle cell disease, and to build     multivariate models to explain both patients' pain and their response to pain, especially,     utilization of health care.   "
165486|NCT00006219|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Dehydroepiandrosterone and clarithromycin may be     effective in preventing multiple myeloma.      PURPOSE: Randomized phase II trial to compare the effectiveness of dehydroepiandrosterone     with that of clarithromycin in treating patients who may be at a high risk of developing     multiple myeloma.   "
182991|NCT00237874|"     We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the     schizophrenia prodrome when they are prescribed aripiprazole.   "
165487|NCT00006220|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal     white blood cells.      PURPOSE: Phase I/II trial to study the effectiveness of arsenic trioxide with or without     tretinoin in treating patients who have hematologic cancer that has not responded to previous     therapy.   "
165488|NCT00006221|"     Phase I trial to study the effectiveness of BMS-247550 in treating patients who have     malignant solid tumors or lymphoma. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die.   "
165489|NCT00006222|"     Phase I trial to study the effectiveness of EMD 121974 in treating patients who have     HIV-related Kaposi's sarcoma. EMD 121974 may stop the growth of Kaposi's sarcoma by stopping     blood flow to the tumor.   "
165490|NCT00006223|"     RATIONALE: Drugs such as flt3L may stimulate a person's immune system and help kill cancer     cells. It is not yet known if flt3L is effective in treating acute myeloid leukemia.      PURPOSE: Randomized phase III trial to determine the effectiveness of flt3L in treating     patients who have acute myeloid leukemia that is in remission.   "
165491|NCT00006224|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who     have persistent or recurrent cancer of the cervix.   "
165492|NCT00006225|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy.      PURPOSE: Randomized phase I/II trial to study the effectiveness of peripheral stem cell     transplantation in treating patients who have breast cancer or hematologic cancer.   "
165493|NCT00006226|"     Phase II trial to study the effectiveness of thalidomide in treating patients who have     relapsed chronic lymphocytic leukemia. Thalidomide may stop the growth of chronic lymphocytic     leukemia by stopping blood flow to the tumor.   "
165494|NCT00006227|"     This phase II trial studies the effectiveness of paclitaxel in treating patients who have     ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die.   "
165495|NCT00006228|"     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Interleukin-2 may     stimulate a person's white blood cells to kill breast cancer cells. Phase II trial to study     the effectiveness of trastuzumab plus interleukin-2 in treating patients who have metastatic     breast cancer that has not responded to previous trastuzumab therapy.   "
165496|NCT00006229|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether paclitaxel and carboplatin are more     effective with or without BMS-275291 for non-small cell lung cancer.      PURPOSE: Randomized phase II/III trial to compare the effectiveness of paclitaxel and     carboplatin with or without BMS-275291 in treating patients who have advanced or metastatic     non-small cell lung cancer.   "
165497|NCT00006230|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients     who have advanced ovarian cancer.   "
165498|NCT00006231|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known if radiation therapy is effective in preventing metastatic cancer following surgery.      PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in     preventing metastatic cancer in patients who have undergone diagnostic procedures to identify     malignant mesothelioma.   "
165499|NCT00006232|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which combination chemotherapy regimen is more     effective for multiple myeloma.      PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens     to see how well they work in treating patients with stage II or stage III multiple myeloma.   "
165500|NCT00006233|"     RATIONALE: Drugs used in chemotherapy such as fludarabine use different ways to stop tumor     cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to     damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells     that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells     can reject the body's normal tissues. Donor lymphocytes that have been treated in the     laboratory may prevent this.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, total-body irradiation,     peripheral stem cell transplantation, and lymphocyte infusion in treating patients who have     stage IV melanoma.   "
165501|NCT00006234|"     RATIONALE: Radioactive drugs, such as holmium Ho 166 DOTMP, may carry radiation directly to     cancer cells and not harm normal cells. Peripheral stem cell transplantation may be able to     replace stem cells that were destroyed by the radioactive drug.      PURPOSE: This Phase I/II trial is studying the effectiveness of holmium Ho 166 DOTMP followed     by peripheral stem cell transplantation in treating patients who have metastatic Ewing's     sarcoma or rhabdomyosarcoma that has spread to the bone.   "
165502|NCT00006235|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin and     carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary     peritoneal cancer.   "
165603|NCT00006351|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining SCH 66336 and gemcitabine may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine in treating     patients who have advanced cancer of the urinary tract.   "
165530|NCT00006265|"     RATIONALE: Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.     Drugs used in chemotherapy, such as cytarabine, use different ways to stop cancer cells from     dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may     kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with     high-dose cytarabine in treating patients who have relapsed or refractory acute myeloid     leukemia.   "
165503|NCT00006237|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is     not yet known whether interferon alfa is more effective with or without combination     chemotherapy and interleukin-2 for melanoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or     without combination chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus     interleukin-2, in treating patients who have melanoma.   "
165504|NCT00006239|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal     white blood cells.      PURPOSE: Phase I trial to study the effectiveness of combining phenylbutyrate and tretinoin     in treating patients who have hematologic cancer.   "
165505|NCT00006240|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combining phenylbutyrate,     dexamethasone, and sargramostim in treating patients who have refractory or relapsed acute     myeloid leukemia.   "
165506|NCT00006241|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy. Treating the peripheral stem cells in the     laboratory to remove any existing cancer cells may improve the effectiveness of the     transplant.      PURPOSE: Randomized phase II trial to compare the effectiveness of treated peripheral stem     cells with that of untreated stem cells in patients who have relapsed low- or     intermediate-grade non-Hodgkin's lymphoma.   "
165507|NCT00006242|"     Phase I trial to study the effectiveness of BMS-214662 in treating patients who have advanced     solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing     so they stop growing or die   "
165508|NCT00006243|"     This randomized pilot clinical trial studies vaccine therapy and sargramostim in treating     patients with stage IV malignant melanoma. Vaccines made from melanoma peptides or antigens     may help the body build an effective immune response to kill tumor cells. Colony-stimulating     factors, such as sargramostim, increase the number of white blood cells and platelets found     in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be     an effective treatment for malignant melanoma   "
165509|NCT00006244|"     This phase II trial studies the effectiveness of melphalan, peripheral stem cell     transplantation, and interleukin-2 followed by interferon alfa in treating patients who have     advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem     cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill     more tumor cells. Interleukin-2 (IL2) may stimulate a person's white blood cells to kill     multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells   "
165510|NCT00006245|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining flavopiridol and paclitaxel     in treating patients who have locally advanced or metastatic esophageal cancer that has not     responded to previous paclitaxel therapy.   "
165511|NCT00006246|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the safety of delivering intrathecal busulfan in children and     adolescents who have refractory CNS cancer and to estimate the maximum tolerated dose of this     treatment regimen.   "
165512|NCT00006247|"     RATIONALE: SU5416 may stop the growth of brain cancer cells by stopping blood flow to the     tumor.      PURPOSE: Phase I trial to study the safety of delivering SU5416 in children who have     recurrent or progressive brain tumors.   "
165513|NCT00006248|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have metastatic or recurrent head and neck cancer.   "
165514|NCT00006249|"     RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet     known if this treatment is more effective than observation following surgery for stage III     melanoma.      PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in     treating patients who have undergone surgery for stage III melanoma.   "
165515|NCT00006250|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. It is not yet known which combination chemotherapy regimen is     more effective for non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination     chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's     lymphoma.   "
165516|NCT00006251|"     This clinical trial studies fludarabine phosphate, low-dose total-body irradiation, and donor     stem cell transplant followed by cyclosporine, mycophenolate mofetil, and donor lymphocyte     infusion in treating patients with hematopoietic cancer. Giving low doses of chemotherapy,     such as fludarabine phosphate, and total body irradiation (TBI) before a donor peripheral     blood stem cell transplant helps stop the growth of cancer cells. It may also keep the     patient's immune response from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte     infusion) after the transplant may help increase this effect. Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.   "
165639|NCT00006387|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. QS21 may     improve the ability of the immune system to respond to disease. Combining vaccine therapy     with QS21 may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus QS21 in treating     patients who have advanced pancreatic or colorectal cancer.   "
165517|NCT00006252|"     RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, before a     donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also     helps stop the patient's immune system from rejecting the donor's stem cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets.      PURPOSE: This phase II trial is studying how well fludarabine and cyclophosphamide followed     by peripheral stem cell transplant works in treating patients with leukemia or lymphoma.   "
165518|NCT00006253|"     Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue     at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher     on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management     attention control (SMAC) intervention, or to a 8-week, 6-contact experimental patient     intervention for management of symptoms and support (PIMSS) targeted toward symptom     management, reducing impact on physical role and social functioning and emotional distress.     Both groups will continue to receive conventional cancer care.      When compared with the self-management attention control intervention, patients exposed to     the experimental intervention will report statistically significant positive effects on the     following:        1. The primary outcome--total number of symptoms reported;        2. The secondary patient outcomes--reduced deterioration in physical role impact and social          functioning, emotional distress, levels of communication with caregiver about care, and          communication and satisfaction with provider care; and        3. Caregiver outcomes--greater involvement in symptom management, increased mastery of the          caregiving process, reduced levels of depression and burden.   "
165519|NCT00006254|"     RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune     system and stop cancer cells from growing.      PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have     advanced solid tumors.   "
165520|NCT00006255|"     RATIONALE: Radiofrequency ablation uses high-frequency electric current to heat and kill     tumor cells. Magnetic resonance imaging-guided radiofrequency ablation may an effective     treatment for primary kidney cancer, liver metastases, or other solid tumors.      PURPOSE: Phase II trial to study the effectiveness of magnetic-resonance-guided     radiofrequency ablation in treating patients who have primary kidney cancer, liver     metastases, or other solid tumors.   "
165521|NCT00006256|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining paclitaxel with radiation therapy may kill more tumor cells.      PURPOSE: This trial is to study the effectiveness of concurrent administration of     chemotherapy and radiation therapy in treating women who have stage II or stage III breast     cancer by examining the complications and cosmetic effects.   "
165522|NCT00006257|"     RATIONALE: Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the     tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining SU5416 with chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining SU5416 and paclitaxel in     treating patients who have advanced cancer.   "
165523|NCT00006258|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one drug or combining chemotherapy with radiation therapy may kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     radiation therapy in treating patients who have surgically resected, newly diagnosed     medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected     ependymoma.   "
165524|NCT00006259|"     RATIONALE: Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor     and cause less damage to normal tissue.      PURPOSE: Phase II trial to study the effectiveness of stereotactic radiation therapy in     treating patients who have brain metastases.   "
165525|NCT00006260|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Drugs such     as mesna may be effective in preventing some of the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of     etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have     metastatic breast cancer.   "
165526|NCT00006261|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune     cells that were destroyed by chemotherapy. Donor lymphocytes may attack and destroy cancer     cells.      PURPOSE: This phase II trial is studying the effectiveness of combination chemotherapy,     peripheral stem cell transplantation, and donor lymphocyte infusion in treating women with     stage IV breast cancer.   "
165527|NCT00006262|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating     patients who have refractory stage III or stage IV ovarian epithelial cancer.   "
165528|NCT00006263|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide,     and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.   "
165529|NCT00006264|"     RATIONALE: Antiviral drugs such as zidovudine and ganciclovir act against viruses and may be     an effective treatment for HIV. Interleukin-2 may stimulate a person's white blood cells to     kill lymphoma cells. Combining these treatments may be effective in treating AIDS-related     primary central nervous system lymphoma.      PURPOSE: Phase II trial to study the effectiveness of combining zidovudine, ganciclovir, and     interleukin-2 in treating patients who have AIDS-related primary central nervous system     lymphoma.   "
165652|NCT00006400|"     The purpose of this study is to determine if hydroxyurea therapy is effective in the     prevention of chronic end organ damage in pediatric patients with sickle cell anemia.   "
165531|NCT00006267|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients     who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer.   "
165532|NCT00006268|"     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.     This may be an effective treatment for malignant glioma.      PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating     patients who have malignant glioma.   "
165533|NCT00006269|"     RATIONALE: Octreotide may be effective in preventing diarrhea that is caused by treatment     with irinotecan.      PURPOSE: Randomized phase III trial to study the effectiveness of octreotide in preventing     diarrhea in patients who are receiving irinotecan for metastatic colon cancer.   "
165534|NCT00006270|"     OBJECTIVES: I. Determine the randomness of adrenocorticotropic hormone (ACTH) and cortisol     secretion using approximate entropy in patients who have sustained a head injury.      II. Determine the correlation between randomness of ACTH and cortisol secretion and stages of     sleep in these patients.   "
165535|NCT00006271|"     OBJECTIVES:      I. Determine the incidence of neuroendocrine dysfunction in patients with closed head     injuries admitted to the Transitional Learning Community in Galveston, Texas, for     rehabilitation.   "
165536|NCT00006272|"     OBJECTIVES:      I. Compare the total daily energy expenditure in infants with ventricular septal defects vs     healthy control infants.   "
165537|NCT00006273|"     OBJECTIVES: I. Compare the resting energy expenditure using respiratory calorimetry in     infants and children with moderate to severe cystic fibrosis versus age matched healthy     controls.      II. Determine the total energy expenditure and energy spent on physical activity using the     doubly labeled water method in these patient populations.   "
165538|NCT00006274|"     OBJECTIVES:      I. Determine the total energy expenditure in term and preterm infants in both well and ill     states using the doubly labeled water method.   "
165539|NCT00006275|"     OBJECTIVES:      I. Determine the therapeutic efficacy and safety of topical calcitriol in children with     psoriasis.   "
165540|NCT00006276|"     This study will evaluate the safety and effectiveness of micellar paclitaxel for treating     severe psoriasis. Paclitaxel in another formulation (Taxol) is approved by the Food and Drug     Administration for use in patients with cancer. This drug can decrease growth of cancer cells     and of new blood vessels. Because patients with psoriasis have an increase in skin cell and     blood vessel growth, paclitaxel may also improve their condition. The dose of drug used in     this study is much lower than those used to treat cancer patients and is expected to cause     relatively few side effects.      Patients 18 to 70 years of age with psoriasis lesions affecting at least 20% of their skin     may be eligible for this study. Candidates will be screened with a history and physical     examination, blood and urine tests, electrocardiogram, and possibly an exercise stress test.      Participants will receive six intravenous (through a vein) infusions of paclitaxel over a     6-month period. Each infusion will take about 2 hours. Patients will stay in the clinic for     observation for at least 1 hour before going home and will return to the clinic for follow-up     examination and tests one week after each infusion. However, on weeks 0 and 8 visit will last     for approximately 8 hours and will require a return to the clinic the following morning.     Blood collection will be performed during the week 0 and 8 visits to determine how fast     Micellar Paclitaxel is eliminated from your body. Approximately 2 teaspoons of blood will be     taken prior to the infusion, twice during the infusion, and eight times during the 22 hours     following the infusion for a total of eleven samples. These return visits will last     approximately 1-2 hours. Patients will have the following procedures:        1. A skin biopsy (removal of a small tissue sample for microscopic examination) will be          done at the first visit (week 0) and again at weeks 6, 14 and 22. The area of the biopsy          will be numbed with an anesthetic, and a small circle of skin about the width of a          pencil eraser and half as deep will be cut and lifted away. Stitches will be placed and          removed 1 to 2 weeks later.        2. A history and physical examination will be done at every visit. Patients will be          interviewed about changes in their skin condition and about treatment side effects and          will be examined by a nurse or physician.        3. Blood and urine samples will be collected at frequent intervals (nearly every visit) to          test for side effects.        4. Photographs of the skin will be taken at the first visit and at several later visits to          document changes in psoriasis.        5. A blood sample will be drawn for genetic testing to look for gene changes in people with          psoriasis.        6. An electrocardiogram will be taken at the last visit. This will be done at week 24 and          compared to the screening EKG.        7. Gonadal toxicity monitoring will be started with all patients entered into the protocol          as of May 2001. Blood will be drawn to measure Inhibit A for females and Inhibit B for          males at weeks 0, 6, 14, and 22.   "
165541|NCT00006278|"     This study is designed to provide information about the cause of two unusual types of     Cushing's syndrome and to evaluate quality of life before and after cure of the disease. In     Cushing's syndrome, the adrenal glands produce too much of the hormone cortisol. This often     causes weight gain, skin changes (bruising and stretch marks), and mood changes such as     irritability, easy crying and depression. Adrenocorticotrophic hormone (ACTH) normally     regulates cortisol production; when cortisol is low, ACTH rises, stimulating the adrenals to     produce more cortisol, and when cortisol is high, ACTH levels fall. In two forms of Cushing's     syndrome, however, the adrenal glands produce cortisol even when ACTH is low.      Patients 18 years of age and older with Cushing's syndrome not related to ACTH production may     participate in this study. Candidates will be have a history and physical examination,     electrocardiogram, urine, blood and saliva tests, and a computerized tomography (CT) scan of     one or both adrenal glands. They will fill out questionnaires on their disease symptoms,     quality of life, and on basic information about themselves, such as marital status, education     level, place of residence, etc. Finally, they will have a corticotropin-releasing hormone     (CRH) test to confirm that they have the form of Cushing's syndrome under study in this     protocol. This test involves collecting blood samples at intervals before and after     administration of sheep CRH to measure cortisol and ACTH levels.      Participants will undergo 3 to 7 days of testing to determine if their cortisol level rises     after taking certain medicines or eating certain foods. These foods and medicines, chosen to     mimic or stimulate substances already in the body, are: glucagon, ACTH,     gonadotropin-releasing hormone, vasopressin, thyrotropin-releasing hormone, and a mixed meal     consisting of a protein, carbohydrate and fat (usually chicken breast and a milkshake-like     drink). Blood will be collected at intervals before and after taking the food or medicine to     measure cortisol blood levels. Blood will also be collected while the patient is in a     standing position and while lying in bed, because changes in posture can cause substances in     the body to increase or decrease. Depending on the individual's response to these tests,     additional tests may be done with insulin, glucose, luteinizing hormone and     follicle-stimulating hormone.      Patients who do not respond to these substances will undergo adrenalectomy (surgery to remove     one or both adrenal glands). This is standard treatment for this type of Cushing's syndrome.     It is usually done by laparoscopy, in which air is injected into the abdomen through tubes     inserted through a small incision, enabling the surgeon to see the organs and remove the     gland. Part of the removed tissue will be examined to learn about what causes this type of     Cushing's syndrome; it may also be used for genetic studies related to the disease. Patients     will stay in the hospital for a week to 10 days for observation and treatment and then will     be discharged to the care of their own doctor. They will continue to complete the quality of     life questionnaire every 3 months for 2 years.      Patients with normal adrenal glands who are participating in National Cancer Institute     studies and are scheduled for adrenalectomy as part of their standard treatment will also be     recruited for this study to serve as controls. The patients will have a 24-hour urine     collection, and part of the adrenal gland tissue removed for their treatment will be used for     research purposes of this study, possibly including genetic study.   "
165542|NCT00006279|"     The purpose of this study is to see if it is safe to give nevirapine (NVP) to breast-feeding     babies from birth to the age of 6 months and to determine what dose of NVP should be given.      Breast-feeding has been shown to be very important for the physical and mental health of     infants. This is especially true during the first 6 months of life. However, an HIV-positive     mother can pass the virus on to her baby by breast-feeding. Because of this risk,     HIV-positive mothers are encouraged to formula-feed, not breast-feed, their babies. In     developing countries, however, some women cannot afford to formula-feed. If they do     formula-feed, these women risk exposing their HIV status. These women have great need for     methods that can lower the chance that they will pass HIV on to their babies. This study will     test NVP as a way of doing this.   "
165543|NCT00006280|"     This study's primary goals are to test the safety and effectiveness of Tobramycin for     Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of     age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already     been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung     fluid will be examined for bacteria before and after the 28-day treatment. The amount of     bacteria before and after treatment will be compared. This will indicate whether the     antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients     will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the     patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr     but contains no medication).   "
165604|NCT00006352|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. BCG may activate the immune     system to kill tumor cells. Combining monoclonal antibody therapy with BCG may kill more     tumor cells. It is not yet known if monoclonal antibody therapy plus BCG is an effective     treatment for limited-stage small cell lung cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of monoclonal antibody     therapy plus BCG in treating patients who have limited-stage small cell lung cancer.   "
165605|NCT00006353|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known if radiation therapy is more effective with or without temozolomide     for glioblastoma multiforme.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.   "
165544|NCT00006285|"     The purpose of this study is to learn more about how the brain allows people to focus on     important objects and filter out unimportant ones when looking at visual images.      Our senses provide us with a vast amount of information at any given moment in time. For     example, visual scenes contain many different objects that cannot be processed simultaneously     because of the limited processing capacity of the brain's visual system. Evidence suggests     that a a network of brain regions selects relevant information and filters out irrelevant     information when people view cluttered visual scenes. This study will use transcranial     magnetic stimulation (TMS) and functional magnetic resonance imaging (fMRI) to determine how     the different brain regions involved in attentional control and filtering interact.      Participants in this study will undergo computer tests, an MRI scan, and TMS. During the MRI,     participants will look at pictures and count objects appearing on a screen. During the TMS,     participants will perform a computer test. Participants' ability to pay attention will be     tested with and without TMS. Participants may be asked to return for additional tests in the     future....   "
165545|NCT00006286|"     TADS is designed to compare the effectiveness of established treatments for teenagers     suffering from major depressive disorder (MDD). The treatments are: psychotherapy (talking     therapy); medication; and the combination of psychotherapy and medication. Altogether, 432     teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in     the United States.      The TADS design will provide answers to the following questions: What is the long-term     effectiveness of medication treatment of teenagers who have major depression? What is the     long-term effectiveness of a specific psychotherapy (talking therapy) in the treatment of     teenagers who have major depression? How does medication treatment compare with psychotherapy     in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the     cost-effectiveness of medication, psychotherapy and combined treatments?      The medication being used in this study is called fluoxetine. Fluoxetine is also known as     Prozac. Research has shown that medications like Prozac help depression in young persons.     Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent     (ages 7 to 17 years) depression.      The psychotherapy or talking therapy being used in this study is called Cognitive     Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his     or her family member (e.g., parent) new skills to cope better with depression. Specific     topics include education about depression and the causes of depression, setting goals,     monitoring mood, increasing pleasant activities, social problem-solving, correcting negative     thinking, negotiation, compromise and assertiveness. CBT sessions may also help with     resolving disagreements as they affect families.   "
165546|NCT00006289|"     This study will examine the effectiveness of the drug neurotropin in treating chronic pain     after injury to a limb or a large nerve.      Two groups of patients will participate in this study: patients with complex regional pain     syndrome type 1, or CRPS-I (also called reflex sympathetic dystrophy) and patients with     complex regional pain syndrome type 2, or CRPS-II. CRPS-I is pain that develops after     relatively minor injury to an arm or leg, but lasts much longer and is much more severe than     would normally be expected. CRPS-II is pain resulting from injury to a large nerve.     Candidates will have a history and physical examination, blood tests, and electrocardiogram.     Participants will undergo the following tests and procedures:      Patients with CRPS I and II will receive an individualized regimen of physical therapy and     standard treatment to control their pain. In addition, they will receive neurotropin or     placebo tablets for 5 weeks, then no trial medicine for at least 1 week, and then the other     trial drug for the next 5 weeks. That is, patients who took placebo the first 5 weeks will     take neurotropin the second 5 weeks and vice versa. Neither the patients nor the doctors will     know who received which drug during the two intervals until the study is over. Patients will     complete questionnaires about their pain, quality of life, and ability to perform daily     living activities. They will have various tests to measure pain (such as sensitivity to heat     and cold, to an electric current, to a mild pin prick, etc.); to provide information about     changes in their condition (such as tests of range of motion of joints and limb size); to     measure blood circulation and sweating in the arm or leg (such as measurements of blood flow     to the limb, skin temperature, and sweat production), and other procedures.   "
165547|NCT00006290|"     The purpose of this study is to learn how changes in body build affect the lives of people     taking anti-HIV medications. By learning this, a set of questions can be created to help     understand how changes in body build and image affect people living with HIV infection.      A set of questions used to measure body image might be useful in future HIV studies. It may     help doctors understand patient concerns about their body image and why some patients stop     taking their anti-HIV medications.   "
165548|NCT00006291|"     The purpose of this study is to see if adding an HIV vaccine (ALVAC-HIV vCP1452), IL-2     (interleukin-2, a protein found in the blood that helps boost the immune system), or both to     anti-HIV-drug therapy is safe, tolerable, and effective in controlling viral load (level of     HIV in the body). (This study has been changed to clarify drug name.) Anti-HIV drugs can help     reduce a patient's viral load. However, HIV can still remain in CD4 cells (cells of the     immune system that help fight infection). Combining an HIV vaccine, IL-2, or both with     anti-HIV drugs may help reduce the number of HIV-infected cells.   "
165557|NCT00006301|"     This study will identify and characterize immune factors involved in hepatitis C infection     and elimination of the virus. Individual responses to hepatitis C infection vary; some people     are able to eliminate the virus, whereas others remain chronically infected. This study may     identify factors important in preventing infection that may be of help in developing a     vaccine or more effective treatments.      People over 18 years old who have been exposed to hepatitis C virus may participate in this     study. Subjects will be recruited from the National Institutes of Health, Inova Fairfax     Hospital, Occupational Medical Services-IDP P.C., Washington Hospital Center and Holy Cross     Hospital, all in the Washington, D.C. metropolitan area. Individual patients from other     centers will also be recruited on a case by case basis.      Participants will have 40 to 60 cc (1 to 2 ounces) of blood drawn at seven intervals. The     first collection will be as soon as possible after exposure to hepatitis C virus and then     again at 2, 4, 6, 12, 24, and 48 weeks after exposure. The white blood cells will be studied     for their response to the virus, and markers for infection will be followed. If infection     develops, additional samples of blood may be requested, and patients will be offered     evaluation for treatment. Test results will be kept confidential and will not be entered into     any medical records.   "
165549|NCT00006292|"     This study will test whether the drug combination of methotrexate and infliximab     (anti-TNF-alpha antibody) is more effective than methotrexate alone for treating rheumatoid     arthritis early in the disease. (The Food and Drug Administration has approved both treatment     regimens for patients with long-standing rheumatoid arthritis.) The study will also evaluate     how effectively magnetic resonance imaging (MRI) can detect differences in the development of     bone damage in the two treatment groups by as early as 6 months.      Patients 18 years of age and older who have had rheumatoid arthritis for less than 2 years     and who have four or more affected joints may be eligible for this 1-year study. Patients     must have received methotrexate treatment in the past without complete success, and must not     have been treated previously with Anti-Thymocyte therapy.      All participants will receive 20 Mg./week of methotrexate. In addition, patients will be     randomly assigned to receive a monthly infusion of infliximab or placebo (a fluid that     contains no active drug). After 6 months, all patients will receive active infliximab for the     remaining half year of the study. Patients will also receive folic acid (1mg/day), Vitamin D     (400 IU/day), and calcium supplements. They may continue to take prednisone (no more than 10     Mg./day) and non-steroidal anti-inflammatory drugs (NSAIDS). Medication dosages will be     adjusted as needed if pain and joint swelling worsen. Over the course of the study, patients     will come to NIH for 15 visits and undergo the following tests and procedures:        1. Joint examination-at every visit.        2. Drug side effects evaluation-at every visit during the study and after the study at 24          and 36 months by questionnaires to be filled out and returned.        3. Hand and feet X-rays at the first visit, at 6 months and at 12 months.        4. MRIs of the wrist to examine damage in the bone and synovial tissue (tissue lining the          joint)-before treatment begins and at weeks 15, 27 and 54. For this study, the patient          lies still in a narrow cylinder (the scanner) with a strong magnetic field. A contrast          material (gadolinium) is injected into the blood to enhance the images of the synovium.          The MRI takes about 45 minutes.        5. DEXA scans (dual emission X-ray absorptiometry) of the lower spine, one hip and one          wrist to measure bone density and assess bone loss-before treatment begins and at weeks          27 and 54. This X-ray test takes about 5 to 10 minutes.        6. CTs (computed tomography) of one hand to assess joint damage in the wrist-before          treatment begins and at weeks 27 and 54. Only half the patients in the study will have          this X-ray study, which produces 3-dimensional images of the hand. It will be done to          compare the location, size and change of damage in the wrist seen on CT with the          information obtained on MRI. The procedure takes about 5 to 10 minutes to complete.        7. Blood tests-at every visit to evaluate treatment response and side effects.   "
165550|NCT00006294|"     To examine whether the association between selected hypertensive genes and combined fatal     coronary heart disease and nonfatal myocardial infarction in high-risk hypertensives is     modified by the type of antihypertensive treatment, leading to differential risks of coronary     heart disease.   "
165551|NCT00006295|"     To study the genetic cause of low HDL-C, a risk factor for premature atherosclerotic vascular     disease in patients with normal total cholesterol. The focus is primarily on the     identification of a single mutation, as has been demonstrated in one family.   "
165552|NCT00006296|"     To assess in four large Chicago population cohorts whether young adult and middle-aged risk     factor status has an impact not only on average annual Medicare costs, but also on cumulative     and lifetime Medicare costs, to ages 70, 75, 80, >80, including to death, and during the last     one to two years of life.   "
165553|NCT00006297|"     To investigate whether traditional risk factors and novel risk factors predict higher risk of     atherosclerotic cardiovascular disease (ASCVD) in a prospective study of incident dialysis     patients.   "
165554|NCT00006298|"     The main goal of this study is to find out how the immune system responds to a specific type     of HIV infection, known as C HIV-1, in order to develop a vaccine against this type of     infection. The study involves Southern African populations.      The HIV-1 virus changes rapidly and many different subtypes have been found. In South Africa,     limited data have suggested Subtype C HIV-1 is the most common. This study strives to verify     the most common subtype and also look at genetic differences and immune responses among newly     infected individuals. Results will aid in the development of vaccines specific for certain     geographical areas.   "
165555|NCT00006299|"     This study will evaluate the effects of the new anti-inflammatory drug, Celebrex, on     relieving pain after oral surgery. It is also designed to assess the drug's selective     inhibition of a chemical called cyclooxygenase-2 and not its closely related form,     cyclooxygenase-1. This selective inhibition allows pain alleviation without the adverse side     effects (e.g., bleeding and stomach upset) often associated with anti-inflammatory drugs.      Healthy volunteers who require removal of their third molars are eligible for this study.     Participants will have oral surgery for tooth extraction after receiving a local anesthetic     (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. On the evening     before and 1 hour before surgery, patients will be given a dose of either the standard     anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or Celebrex, or a placebo (a pill     with no active ingredient). After surgery, a small piece of tubing will be placed in each     extraction site and tied to an adjacent tooth to hold it in place. Samples will be collected     from the tubing to measure chemicals involved in pain and inflammation. Patients will stay in     the clinic for up to 6 hours after surgery while the anesthetic wears off and will complete     pain questionnaires. During that time, they may receive acetaminophen plus codeine (Tylenol     3), if needed, for pain. The tubing then will be removed and the patient discharged with     standard pain medication.   "
165556|NCT00006300|"     The purposes of this study are threefold: 1) to evaluate the prevalence and risks of oral     complications in patients with aplastic anemia; 2) to evaluate if oral problems in these     patients can predict their response to treatment; and 3) to review complications of dental     treatment in these patients in order to establish treatment guidelines.      This study will be performed through a review of medical charts of 79 patients with aplastic     anemia and 67 patients with schizophrenia who were treated at the National Institutes of     Health Dental Clinic between 1993 and 1999. The schizophrenia patients will serve as a     control population.      Demographic, clinical and radiographic information will be collected for all patients.     Additional data collected only for aplastic anemia patients will include medical therapy,     disease duration, blood cell counts, oral problems that developed during treatment and     treatment response.   "
165558|NCT00006304|"     As new drugs and vaccines are developed to prevent HIV disease progression and prolong     survival of HIV infected patients, the short-term safety and effectiveness of these     treatments are evaluated in research studies. However, the long-term effects, whether they     are benefits or side effects, need to be studied as well. These long-term effects may have a     greater impact on infants and children who are still growing and developing. The purpose of     this study is to follow HIV-exposed and HIV infected infants, children, and adolescents who     are seen at Pediatric AIDS Clinical Trials Group (PACTG) study sites. These patients will be     observed for long-term benefits or any late harmful effects of medications or vaccines.   "
165622|NCT00006370|"     RATIONALE: Radiolabeled drugs such as yttrium Y 90-DOTA-tyr3-octreotide can locate tumor     cells and either kill them or deliver tumor-killing substances to them without harming normal     cells.      PURPOSE: Phase II trial to study the effectiveness of yttrium Y 90-DOTA-tyr3-octreotide in     treating patients who have refractory small cell lung cancer or metastatic breast cancer.   "
165559|NCT00006305|"     The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients     being assigned at random to initial elective revascularization with aggressive medical     therapy or aggressive medical therapy alone with equal probability, and simultaneously being     assigned at random to an insulin providing or insulin sensitizing strategy of glycemic     control (with a target value for HbA1c of less than 7.0% for all patients).      SPECIFIC AIMS      A. Primary Aim      The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment     efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the     setting of uniform glycemic control and intensive management of all other risk factors     including dyslipidemia, hypertension, smoking, and obesity:        1. Coronary Revascularization Hypothesis: a strategy of initial elective revascularization          of choice (surgical or catheter-based) combined with aggressive medical therapy results          in lower 5-year mortality compared to a strategy of aggressive medical therapy alone;        2. Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a          strategy of hyperglycemia management directed at insulin sensitization results in lower          5-year mortality compared to a strategy of insulin provision.      B. Secondary Aims      The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial     infarction or stroke combined endpoint event rate between the revascularization versus     medical therapy groups and between the insulin sensitization versus insulin provision groups;     b) comparing rates of myocardial infarction, other ischemic events, angina and quality of     life associated with each revascularization and hyperglycemia management strategy; c)     evaluating the relative economic costs associated with the trial treatment strategies, d)     exploring the effect of glycemic control strategy on the progression and mechanism of     vasculopathy including changes in PAI-1 gene expression.   "
165560|NCT00006306|"     To determine the effects of chronic ozone exposure on lung function in young men and women.   "
165561|NCT00006307|"     To investigate the relationship between obesity, body mass index (BMI) rebound, body     composition changes, associated factors (e.g., diet, physical activity), and cardiovascular     risk factor status in a longitudinal study of young children, age three at the beginning of     the study.   "
165562|NCT00006308|"     To investigate cardiovascular events among individuals with low sodium intake or large weight     changes in a prospective observational follow-up of subjects from the Trials of Hypertension     Prevention (TOHP) study.   "
165563|NCT00006309|"     To quantify the role of dietary factors in the etiology of coronary heart disease by pooling     data from 10 major prospective studies on diet and coronary heart disease.   "
165564|NCT00006310|"     To determine the seroprevalence of Kaposi's sarcoma-associated herpesvirus (KSHV/HHV8) in     blood donors from Texas. Also to examine the donors' demographic characteristics and to     characterize the KSHV using polymerase chain reaction.   "
165565|NCT00006311|"     To examine the role of reduced vagal control of heart rate in the increased risk of cardiac     mortality associated with anxiety in a population with established coronary artery disease     (CAD). A second objective is to determine whether the effects of anxiety are independent of     the effects of depression.   "
165566|NCT00006312|"     To examine the cost effectiveness of hereditary hemochromatosis (HH) screening in primary     care.   "
165567|NCT00006313|"     To conduct extended analysis of the Postmenopausal Estrogen/Progestins Intervention PEPI     trial database to address questions related to cardiovascular disease risk factor response     and the possible determinants of this response.   "
165568|NCT00006314|"     To investigate the relationship between HCMV and bone marrow progenitor cells to understand     whether HCMV is latent in CD34 + bone marrow progenitors and the mechanism by which the virus     remains in a latent state.   "
165569|NCT00006315|"     To examine the dose-response of exercise on long-term weight loss in overweight adult women.   "
165570|NCT00006316|"     The purpose of this study is to determine whether stopping preventive histoplasmosis     medications in patients who are currently receiving effective anti-HIV drugs will place them     at risk for getting histoplasmosis again.      Histoplasmosis is a serious opportunistic (AIDS-related) infection that responds well to     antifungal medications. Before anti-HIV drugs, patients with histoplasmosis required lifelong     antifungal therapy. Patients who take anti-HIV drugs for a long time may see an improvement     in their immune system functions. Improved immune function may eliminate the need for     long-term preventive treatment with antifungal agents. Doctors want to see if the improved     immune functions allow preventive treatment for histoplasmosis to be stopped. (This study has     been changed to include histoplasmosis treatment with drugs other than itraconazole.)   "
165571|NCT00006318|"     This study will use magnetic resonance imaging (MRI) to examine the role of prostaglandins-a     type of fatty acid with hormone-like actions-in the regulation of brain blood flow. The     results will provide information on how to better use this technique to study brain function,     which, in turn, may lead to a better understanding of certain illnesses and more effective     treatments.      Healthy normal volunteers 18 years of age and older may be eligible for this study.     Participants will fill out a health questionnaire and undergo a history, physical examination     and MRI studies. MRI is a diagnostic tool that uses a strong magnetic field and radio waves     instead of X-rays to show structural and chemical changes in tissues. During the scanning,     the subject lies on a table in a narrow cylinder containing a magnetic field. An intercom     system allows the subject to speak with the staff member performing the study at all times     during the procedure. Four separate studies will be done-two carbon dioxide inhalation     studies and two functional activation studies-as follows:      Carbon dioxide inhalation (indomethacin): This study is done in two parts. In both parts, an     MRI brain scan is done. During the scan, the subject inhales an air mixture containing 6%     carbon dioxide through a facemask or mouthpiece. Blood pressure and heart rate are monitored     during inhalation of the mixture. For the second part of the study, indomethacin-a     non-steroidal anti-inflammatory drug-is injected through a catheter (thin flexible tube) in     an arm vein. Indomethacin inhibits prostaglandin production. Total scan time averages between     45 and 90 minutes, with a maximum of 2 hours.      Carbon dioxide inhalation (rofecoxib and celecoxib): This study is identical to the one     above, except either rofecoxib or celecoxib is given instead of indomethacin. Both of these     drugs are also non-steroidal anti-inflammatory drugs that inhibit prostaglandin production.     Unlike indomethacin, rofecoxib and celecoxib are given orally instead of through a vein, so,     to allow time for the drug to be absorbed, the second scan is delayed for 2 hours.      Functional activation (indomethacin): This study is done in two parts. In both parts, a MRI     brain scan is done. During the study, the subject performs a simple motor task, such as     finger tapping. For the second part of the study, indomethacin is injected through a catheter     in an arm vein.      Functional activation (rofecoxib and celecoxib): This study is identical to the indomethacin     functional activation study, except either rofecoxib or celecoxib is given instead of     indomethacin. Because they are given orally instead of through a vein, the second scan is     delayed 2 hours to allow time for the drug to be absorbed.   "
165582|NCT00006329|"     Parathyroid glands are small endocrine glands that secrete a hormone which controls blood     calcium levels. Primary hyperparathyroidism (PH) is a common disorder whereby one or more of     these glands may enlarge and overproduce their hormone. Subsequently, the elevated blood     calcium can cause many other symptoms and problems. The standard treatment is surgical     removal of the gland(s) causing the disorder. The standard safe and effective operation has     been the bilateral open parathyroid exploration (BOPE). A newer procedure using a radioactive     compound that concentrates in the parathyroid glands allows a more limited operation to find     and remove the causative gland [Minimally-Invasive Radioguided Parathyroidectomy (MIRP)]. The     radiation exposure is minimal and safe. Although the operation may prove to be less     expensive, it is not certain whether it is as effective or as safe as BOPE. This study serves     to directly compare the costs, the effectiveness, and the safety associated with each type of     operation. All patients (adolescents and older) with PH are candidates to participate. The     participants will be randomly assigned to the MIRP group or the BOPE group independently of     patient or physician preferences. MIRP patients will undergo a sestamibi nuclear medicine     scan to attempt to localize the specific parathyroid gland causing the hyperparathyroidism     and subsequently a limited operation under local anesthesia to remove the single gland.     Parathyroid hormone levels will be measured during the operation to ensure that the patient     has been cured. If not, the standard BOPE procedure will be completed. The total cost of the     care will be tracked for each group. Careful testing for complications such as vocal cord     dysfunction will be done. General Health status and pain levels will be measured before and     after each operation. Patient satisfaction with the operation and care will also be assessed.   "
165653|NCT00006401|"     To determine whether or not inhaled nitric oxide (iNO) safely decreases the incidence of     chronic lung disease (CLD) in premature infants.   "
165572|NCT00006319|"     This study will try to identify mutations in the genes responsible for primary     immunodeficiency disorders (inherited diseases of the immune system) and evaluate the course     of these diseases in patients over time to learn more about the medical problems they cause.     The immune system is composed of various cells (e.g., T and B cells and phagocytes) and other     substances (complement system) that protect the body from infections and cancer.     Abnormalities in the gene(s) responsible for the function of these components can lead to     serious infections and other immune problems.      Patients with Wiskott-Aldrich syndrome, adenosine deaminase (ADA) deficiency, Janus     Associated Kinase 3 (JAK3) deficiency, common variable immunodeficiency (CVID) and other     immunodeficiencies may be eligible for this study. Participants will undergo a medical and     family history, physical examination, and additional procedures and tests that may include     the following:        1. Blood tests for: routine laboratory studies (i.e. cell counts, enzyme levels,          electrolytes, etc.); HIV testing; immune response to various substances; genetic          testing; and establishment of cell lines to maintain a supply of cells for continued          study        2. Urine and saliva tests for biochemical studies        3. Skin tests to assess response to antigens such as the viruses and bacteria responsible          for tetanus, candida, tuberculosis, diphtheria, chicken pox, and other diseases.        4. Skin and lymph node biopsies for tissue and DNA studies        5. Chest X-ray, CT scans, or both to look for cancer or various infections.        6. Pulmonary function test to assess lung capacity and a breath test to test for H. pylori          infection.        7. Dental, skin and eye examinations.        8. Treatment with intravenous immunoglobulins or antibodies to prevent infections.        9. Apheresis for collecting white blood cells to study cell function. In this procedure,          whole blood is collected through a needle placed in an arm vein. The blood circulates          through a machine that separates it into its components. The white cells are then          removed, and the red cells, platelets and plasma are returned to the body, either          through the same needle or through a second needle placed in the other arm.       10. Bone marrow sampling to study the disease. A small amount of marrow from the hipbone is          drawn (aspirated) through a needle. The procedure can be done under local anesthesia or          light sedation.       11. Placental and umbilical cord blood studies, if cord blood is available, to study stem          cells (cells that form blood cells).      Information gained from this study may provide a better understanding of primary     immunodeficiencies, leading to better diagnosis and treatment. In addition, study     participants may receive medical and genetic counseling and may be found eligible for other     NIH studies on these diseases.   "
165573|NCT00006320|"     This study will determine if blood levels of anti-HIV drugs in pregnant women change at     different stages of pregnancy and if these changes require dosage adjustments in order to     maintain adequate drug levels during pregnancy. Anti-HIV medications are recommended for     HIV-infected women during pregnancy not only to treat their infection, but also to reduce the     chance of passing the virus to the baby during pregnancy. Changes in the body that occur     during pregnancy may affect how the body uses and eliminates these drugs, reducing their     levels during pregnancy.      Pregnant women 18 years of age or older who are infected with HIV may be eligible for this     study. Candidates will have a medical history and physical examination, pregnancy test and     blood tests.      Participants will come to the NIH Clinical Center once every 6 to 12 weeks until around their     34th week (8 months) of pregnancy and then again at least 1 month after the birth of the baby     to have blood drawn. A catheter (thin plastic tube) will be placed in a vein to avoid     multiple needle sticks for blood sampling during the day. The first sample will be collected     before the patient takes the morning doses of anti-HIV medicines and additional samples will     be drawn at 1, 2, 4, 8 and 12 hours after taking the medication. A urine sample will also be     collected at each visit.   "
165574|NCT00006321|"     To assess associations between behavioral/neuropsychological measures and various measures of     sleep disordered breathing (SDB) and to determine the prevalence of SDB in children with     Attention Deficit Hyperactivity Disorder (ADHD).   "
165575|NCT00006322|"     To investigate the relationship of birth weight and childhood blood pressure.   "
165576|NCT00006323|"     To identify physiological and clinical measures of obstructive sleep-disordered breathing     that are associated with increased morbidity in children.   "
165577|NCT00006324|"     The purpose of this study is to find out whether hormonal birth control increases, decreases,     or does not change the risk of women becoming infected with HIV.      Sexual intercourse between men and women is the main way HIV is transmitted. About 90 percent     of HIV infections in women are caused by sexual intercourse. Also, hormonal birth controls     are widely used. This study hopes to find out whether hormonal birth control changes the risk     of women becoming infected with HIV.   "
165578|NCT00006325|"     The purpose of this study is to see if PEG-Intron is safe and tolerated when given to     children, to see how much gets into the blood and how long it stays in the blood, and to see     how well it works to reduce viral load (level of HIV in the blood).      PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It     decreases the ability of HIV to infect the T cells (a special type of cell that helps fight     infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat     hepatitis C in adults, but in this study, it is being used as an investigational agent for     the treatment of HIV/AIDS. It has not been tested in children before and experience with     PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of     PEG-Intron for treating hepatitic C in adults.)   "
165579|NCT00006326|"     The purpose of this study is to see if 3 anti-HIV drug combinations are safe and effective in     patients who have failed previous anti-HIV treatments using nelfinavir (NFV).   "
165580|NCT00006327|"     The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect     intravenous drug users from becoming infected with HIV.   "
165581|NCT00006328|"     This study is intended to help doctors learn about the relationships between specific genetic     makeup (gene markers) and the development of chronic rejection. This study is being done to     see if there is a relationship between genetic patterns and the development of Chronic     Allograft Nephropathy (CAN). Medical scientists also hope to learn more about how genetic     differences between people determine their response to a drug or a disease by storing a small     blood sample in a special bank. This sample may be tested at some point in the future in an     attempt to better understand the factors that may influence rejection, transplantation     outcomes and transplant success rates.   "
165600|NCT00006348|"     RATIONALE: Antiemetic drugs, such as ondansetron, may help to reduce or prevent nausea and     vomiting in patients with advanced cancer.      PURPOSE: This randomized phase III trial is studying how well ondansetron works compared to a     placebo in treating patients with advanced cancer and chronic nausea and vomiting that is not     caused by cancer therapy.   "
165601|NCT00006349|"     RATIONALE: Donepezil and vitamin E may be able to decrease side effects caused by radiation     therapy given to prevent brain metastases in patients with small cell lung cancer. It is not     yet known if donepezil and vitamin E are effective in preventing side effects caused by     radiation therapy to the head.      PURPOSE: Randomized phase III trial to determine the effectiveness of donepezil and vitamin E     in preventing side effects caused by radiation therapy given to prevent brain metastases in     patients who have small cell lung cancer.   "
165583|NCT00006330|"     Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American     herbal medicine practice. Some of its cardiac uses include the treatment of high and low     blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used     as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To     date, little information is known about the effect of hawthorn when taken with other drugs     and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is     to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects     will be recruited by advertisement. The design of the study will include a 10-day and a     three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special     extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover.     There will be a three-week washout period in between treatment phases. On day 10 (phase I)     and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic     analysis. The plasma samples will be measured for digoxin concentration. Additionally, the     subjects will be assessed for any clinical toxicities or adverse events. The significance of     this study is to provide the clinician with information regarding the safe use of digoxin in     combination with the herbal supplement, hawthorn.   "
165584|NCT00006331|"     Research participants will be asked to undergo complete medical history, physical examination     and blood tests. The purpose of these tests is to determine whether persons are predisposed     to develop diabetes mellitus after kidney transplantation and also to make an early diagnosis     if a patient develops diabetes mellitus. Medical information collected as part of the     standard transplant evaluation and posttransplant medical care may be incorporated into this     study. It is important to realize that research subjects will not be given an experimental     drug as part of this study.      After kidney transplantation, research subjects will be followed in the posttransplant clinic     visits. The study will last up to 6 months. During this time the subjects may be asked to     participate in clinical assessment visits (medical history and physical examination), and     also during the third or fourth month after transplant will be asked to do a repeat glucose     tolerance test.   "
165585|NCT00006332|"     Hepatocellular carcinoma (HCC) is a deadly tumor for which the incidence is increasing in the     United States, primarily due to prevalence of hepatitis C infection. An important aspect of     the development of HCC is that it occurs in patients who have underlying cirrhosis of the     liver, thereby limiting the therapeutic options. There is potential curative treatment for     these patients, such as resection of the tumor lesion and liver transplantation, but these     treatments are feasible in a small percent of patients only. Furthermore, the majority of the     patients with HCC are also not candidates for palliative treatments such as percutaneous     ablation of the tumor, chemotherapy or radiation. Additionally, it has been shown that these     palliative treatment modalities do not alter survival, and are associated with significant     risks. Therefore, there are no treatment options for most patients with HCC. A new theory has     emerged in the fight against cancer through inhibition of angiogenesis (development of new     blood vessels). The hypothesis being that if there is no blood supply feeding the tumor     cells cannot divide or survive. One such approach, pioneered in this institution by Drs.     George Brewer and Sofia Merajver, is the anticopper approach using the medication     tetrathiomolybdate (TM). By creating a mild copper deficiency state, several pathways     required for angiogenesis are inhibited. They performed a Phase I trial in which patients     with metastatic cancer were treated with TM resulting in decrease tumor vascularity. TM had     excellent safety profile in this patient population. HCC is well known to be a hypervascular     tumor. An antiangiogenesis approach might provide a novel treatment for this HCC. This is a     pilot study of 10 patients with HCC who are not candidates for curative surgical therapy with     resection or liver transplantation, nor for ablative techniques. Patients seen in the General     Liver clinic and Liver Transplant clinic who have an overall good performance status, with an     expected survival of more than 6 months will be enrolled. After an initial evaluation, they     will be given 120 mg/day of TM in divided doses for one year. The size and vascularity of the     tumor will be evaluated by magnetic resonance imaging (MRI). The primary outcome of this     study is to prevent tumor progression.   "
165586|NCT00006333|"     This research protocol will recruit patients with arthritis and related conditions for the     purpose of screening patients for treatment protocols, and evaluating the natural history of     arthritis and related conditions. Patients will be evaluated clinically, radiographically and     serologically, and standardized data will be uniformly collected on all patients. Additional     imaging using sensitive MRI methods will be obtained in some patients. The collected blood     and tissue will be utilized for laboratory studies to continue research on the pathogenic     mechanisms of rheumatoid arthritis and related autoimmune joint diseases. Data from the     history and physical examination as well as several disability questionnaires in the adult     and pediatric population will be used to phenotypically characterize these patients and     assess outcome and functional status. Any medical care recommended or provided to the     patients will be consistent with routine standards of practice and provided in consultation     with the patient's referring physician.   "
165587|NCT00006334|"     This study examines the clinical and genetic factors related to Turner syndrome, a disorder     of the sex chromosomes. Humans usually have 23 pairs of chromosomes-thin strands of DNA-in     the nucleus of every cell, which contain genes that determine our hereditary makeup. One pair     of chromosomes is the sex chromosomes, designated X and Y. Females usually have two X     chromosomes; however, patients with Turner syndrome have only a single X chromosome or one     normal and one defective X or Y chromosome. This abnormality can cause medical problems such     as short stature, premature ovarian failure and heart or kidney defects. Individuals with     Turner syndrome have an increased risk of thyroid disorders, high blood pressure, diabetes     mellitus, abnormal liver function, hearing loss and osteoporosis. This study will try to     identify the genes responsible for the specific medical problems associated with the     disorder.      Females 10 years of age and older with X chromosome defects may be eligible for this 3- to 5-     day inpatient study at the National Institutes of Health Clinical Center in Bethesda,     Maryland. Participants will have a physical examination, body measurements (height, weight,     hip and waist) and blood drawn for clinical and research purposes.      Participants will have a comprehensive cardiovascular evaluation, including an     electrocardiogram (ECG), 24 hour blood pressure monitoring, magnetic resonance imaging (MRI)     of the heart and aorta, ultrasound imaging of the heart (cardiac echo) and expert     consultation with the NIH Cardiology Service. Women 35 years of age and older may have a     computerized tomography (CT) scan of the coronary arteries to investigate possible blockage     of the heart blood supply.      Risk for diabetes is investigated by studies of the body fat content and an oral glucose     tolerance test. The risk for coronary artery disease is assessed by measurement of     cholesterol and other known risk factors in the blood. Thyroid function and presence of     antibodies to the thyroid gland are also evaluated by blood tests.      Liver function is tested by measurement of products of liver metabolism in the blood and by a     liver ultrasound. Ovary function is investigated by blood tests of estrogen and FSH levels     and pelvic untrasound which visualizes the uterus.      Bone structure and strength are evaluated by routine X-rays of the wrists and spine, and DEXA     scan (a type of X-ray study that measures body fat, muscle and bone thickness). Adults will     also have bone density of the spine and abdominal fat content measured by CT, which is more     accurate than DEXA. Vitamin D levels are measured in blood tests.These are state of the art     diagnostic tests which may uncover unsuspected anatomic problems such as abnormalities of the     aorta or aortic valve which have serious clinical implications and would indicate the need     for close medical follow-up, as well as uncover potential risk for development of diabetes or     osteoporosis in the future, which would also indicate the need for changes in lifestyle or     medical management. Study participants are invited to return for re-evaluation at 1-3 year     intervals. A major goal of follow-up visits is to determine whether there is any enlargement     of aortic diameter or impairment of cardiac function over time.      Some patients may be asked to undergo a skin biopsy (removal of a small sample of skin     tissue) to obtain more information about genetic make-up of cells. Parents of patients may be     contacted (with the patient's permission) to provide a blood or saliva sample for genetic     study to help understand how and why certain traits of Turner syndrome are expressed.   "
165588|NCT00006335|"     The purpose of this study is to learn what factors influence adolescent girls' decisions     regarding testing for carrier status of X-Linked Severe Combined Immunodeficiency (XSCID). It     will provide information about how healthy relatives feel about whether they could be XSCID     carriers, whether carrier testing should be pursued, and, if so, at what age. Commonly known     as Bubble Boy Disease, XSCID is a rare, life-threatening immune system disorder that     affects only males, but females who carry the gene mutation can pass the disease to their     male children.      Adolescent girls 13 to 17 years old who have a relative with XSCID and are known to be at     risk for being carriers are eligible for this study.      Participants will receive genetic counseling to help them decide if they want to be tested     for the XSCID gene. Those who elect to be tested will provide a DNA sample from either a     blood draw or brushing taken from inside the mouth. They will receive the test results from     the same genetic counselor they spoke with before the testing.      All participants will also talk with a psychologist over the phone once a year for 3 years to     answer questions about how they are feeling and what they know about XSCID. They will be     asked to discuss their decision and feelings about carrier testing.   "
165602|NCT00006350|"     RATIONALE: Monoclonal antibodies such as daclizumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Peripheral     stem cell transplantation from a brother or sister may be effective treatment for hematologic     cancer. Sometimes the transplanted cells can be rejected by the body's tissue. Mycophenolate     mofetil, tacrolimus, and donor white blood cells may prevent this from happening.      PURPOSE: Phase II trial to study the effectiveness of mycophenolate mofetil, tacrolimus,     daclizumab, and donor peripheral stem cell transplantation in treating patients who have     hematologic cancer.   "
165654|NCT00006402|"     To determine the influences of diet and physical activity (PA) on total body fatness and     regional fat distribution and the relationship of these to risk factors of cardiovascular     disease during adolescence.   "
165589|NCT00006336|"     This study will examine the effectiveness of Braille reading as a sensory training program     for improving symptoms of focal (localized) dystonia, a movement disorder caused by sustained     muscle contractions. Musicians, writers, typists, athletes and others whose work involves     frequent repetitive movements may develop focal dystonia of the hand. Dystonia patients have     an impaired sense of touch, and it is thought that symptoms may improve with sensory tactile     (touch) training.      Patients with task-specific dystonia and healthy normal volunteers may be eligible for this     8-week study. Patients will undergo evaluation of their dystonia and a complete neurologic     examination. Healthy volunteers will have a complete physical examination.      On the first day of the study, after 4 weeks and after 8 weeks, all participants will have a     gap detection test for sensory perception testing. The test uses eight plastic devices called     JVP-Domes with ridges of different widths on the surface. The subject's arm and hand are held     in palm-up position and the right index finger is tested for about 1 second 20 times with     each dome. The subject is asked to report whether the direction of the dome is vertical or     horizontal. The test takes about 30 minutes. Patients with dystonia will also have a their     symptoms evaluated at these visits. The evaluation involves completing a written     questionnaire and writing a paragraph.      All participants will be trained in Braille reading at NIH. Sessions will be given every day     the first week, twice a week the second and third weeks, and once a week the following weeks.   "
165590|NCT00006337|"     This study will evaluate the effects of an experimental drug called KW-6002 on Parkinson's     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of     long-term treatment with levodopa. This drug blocks the action of the neurotransmitter     adenosine, thought to be involved in producing Parkinson's symptoms.      Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 80     years of age may be eligible for this 7-week study. Participants will have a complete medical     history and physical examination, including blood tests and an electrocardiogram, and     possibly brain magnetic resonance imaging (MRI), CT scan, and chest X-ray.      Patients enrolled in the study will, if possible, stop taking all antiparkinsonian     medications except levodopa (Sinemet) for one month before the study begins and throughout     its duration. For the first 1 to 3 days, patients will be admitted to the NIH Clinical center     to undergo a levodopa dose-finding procedure. For this study, patients will stop taking     Sinemet and instead will have levodopa infused through a vein for up to 8 hours/day. During     the infusions, the drug dose will be increased slowly until either 1) parkinsonian symptoms     improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached.     Symptoms will be monitored frequently to find two infusion rates: 1) one that is less than     what is needed to relieve symptoms, and 2) one that relieves symptoms but may produce     dyskinesias. This procedure will be repeated at the end of weeks 2, 4 and 6 of the study.      When the patient's optimal dose is determined treatment will begin. Patients will take     tablets or capsules containing KW-6002 or placebo (a look-alike pill with no active     ingredient) once a day for 2 weeks, in addition to their regular Sinemet. All participants     will receive placebo at least 2 weeks during the study; some patients will receive only     placebo throughout the entire 7 weeks. At the end of weeks 1, 3 and 5, patients will be     evaluated with a brief physical examination, routine blood and urine tests, and assessment of     any adverse effects.      Throughout the study, parkinsonian symptoms and dyskinesias will be evaluated and blood     samples will be drawn periodically to measure drug levels.   "
165591|NCT00006339|"     The purpose of this study is to compare the safety and effectiveness of an anti-HIV drug     combination with and without hydroxyurea in patients with early HIV infection.      Certain combinations of anti-HIV drugs have been effective in lowering levels of HIV in the     blood and keeping them down. However, these treatments are not effective in some patients.     This study will see if using a combination containing more drugs will help in patients with     early HIV infection.   "
165592|NCT00006340|"     RATIONALE: The Epstein Barr virus can cause cancer and lymphoproliferative disorders.     Ganciclovir is an antiviral drug that acts against the Epstein Barr virus. Arginine butyrate     may make virus cells more sensitive to ganciclovir. Combining ganciclovir and arginine     butyrate may kill more Epstein Barr virus cells and tumor cells.      PURPOSE: Phase I trial to study the effectiveness of arginine butyrate plus ganciclovir in     treating patients who have cancer or lymphoproliferative disorders that are associated with     the Epstein Barr virus.   "
165593|NCT00006341|"     RATIONALE: The use of dentures and dental implants may help maintain chewing and speaking     ability following surgery to remove tumors in the mouth.      PURPOSE: Phase II trial to study the effectiveness of dentures and dental implants in     maintaining the ability to chew and speak in patients undergoing surgery for mouth cancer.   "
165594|NCT00006342|"     RATIONALE: Determination of genetic markers for leukemia or non-Hodgkin's lymphoma that is     secondary to Hodgkin's disease and childhood brain tumors may help doctors to identify     patients who are at risk for these cancers.      PURPOSE: Clinical trial to determine the presence of certain genes in patients who are     receiving treatment for Hodgkin's disease or childhood brain tumors.   "
165595|NCT00006343|"     RATIONALE: Biological therapies such as interferon-alfa and STI571 may interfere with the     growth of cancer cells. It is not yet known if STI571 is more effective than interferon alfa     plus cytarabine for chronic myelogenous leukemia.      PURPOSE: Randomized phase III trial to compare the effectiveness of STI571 with that of     interferon alfa plus cytarabine in treating patients who have newly diagnosed chronic     myelogenous leukemia.   "
165596|NCT00006344|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known which regimen of radiation therapy may be more effective in preventing brain     metastases.      PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in     preventing brain metastases in patients who have small cell lung cancer that has been     diagnosed within the past year.   "
165597|NCT00006345|"     RATIONALE: Denileukin diftitox may be able to deliver cancer-killing substances directly to     T-cell lymphoma cells. Dexamethasone may decrease the side effects of denileukin diftitox.      PURPOSE: Phase II trial to study the effectiveness of dexamethasone in preventing side     effects following treatment with denileukin diftitox in treating patients who have persistent     or recurrent T-cell lymphoma.   "
165598|NCT00006346|"     RATIONALE: Transcendental meditation may be an effective way to decrease the amount of stress     in older women with breast cancer. It is not yet known if transcendental meditation is more     effective than basic breast cancer education in improving quality of life.      PURPOSE: This randomized clinical trialstudies stress reduction in improvingquality of life     in older women with stage II, stage III, or stage IV breast cancer.   "
165599|NCT00006347|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have relapsed or refractory small cell lung cancer.   "
165655|NCT00006403|"     To determine the relation between cardiovascular disease risk factors and systemic markers of     vascular inflammation in the Framingham Study cohort.   "
165606|NCT00006354|"     RATIONALE: Mistletoe lectin may slow the growth of cancer cells and be an effective treatment     for solid tumors.      PURPOSE: Phase I trial to study the effectiveness of mistletoe lectin in treating patients     who have advanced solid tumors that have not responded to previous therapy.   "
165607|NCT00006355|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy and radiation therapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of pyrazoloacridine followed by     radiation therapy in treating adults who have newly diagnosed supratentorial glioblastoma     multiforme.   "
165608|NCT00006356|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so     that it can be removed during surgery.      PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy with or     without surgery in treating patients who have recurrent epithelial ovarian cancer.   "
165609|NCT00006357|"     RATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective     treatment for soft tissue sarcoma.      PURPOSE: Phase I/II trial to study the effectiveness of STI571 in treating patients who have     recurrent or refractory soft tissue sarcoma.   "
165610|NCT00006358|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to     the tumor.      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide     in treating patients who have recurrent or progressive brain tumor.   "
165611|NCT00006359|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as     leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making     androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these     drugs together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide     or goserelin and either flutamide or bicalutamide together with radiation therapy works in     treating patients with prostate cancer.   "
165612|NCT00006360|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating     patients who have stage II or stage III oropharyngeal cancer.   "
165613|NCT00006361|"     RATIONALE: SU5416 may stop the growth of cancer cells by stopping blood flow to the tumor.      PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have     advanced or recurrent cancer of the head and neck.   "
165614|NCT00006362|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have     advanced cancer.   "
165615|NCT00006363|"     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. PSC 833 may increase the effectiveness of chemotherapy by making cancer cells     more sensitive to the drugs. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.     Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. This     randomized phase III trial is studying giving combination chemotherapy together with PSC 833     followed by a peripheral stem cell transplant with or without interleukin-2 to see how well     it works compared to combination chemotherapy alone followed by a peripheral stem cell     transplant with or without interleukin-2 in treating patients with acute myeloid leukemia.   "
165616|NCT00006364|"     Phase II trial to study the effectiveness of homoharringtonine in treating patients who have     chronic phase chronic myelogenous leukemia. Drugs used in chemotherapy, such as     homoharringtonine, work in different ways to stop cancer cells from dividing so they stop     growing or die   "
165617|NCT00006365|"     RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells.     Giving radiation therapy in different ways may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of external-beam radiation therapy     followed by implanted radiation therapy in treating patients who have prostate cancer.   "
165618|NCT00006366|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known which regimen of radiation therapy plus chemotherapy is more     effective for rectal cancer.      PURPOSE: Randomized phase II trial to compare two regimens of radiation therapy plus     chemotherapy followed by surgery in treating patients who have locally advanced cancer of the     rectum.   "
165619|NCT00006367|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral     stem cell transplantation in treating patients who have myelofibrosis.   "
165620|NCT00006368|"     RATIONALE: Radiolabeled drugs such as yttrium Y 90 SMT 487 can locate tumor cells and deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 SMT 487 in treating     patients who have refractory or recurrent cancer.   "
165621|NCT00006369|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     ERA-923 may fight breast cancer by blocking the uptake of estrogen by the tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of ERA-923 in treating     postmenopausal women who have metastatic breast cancer that no longer responds to tamoxifen.   "
165656|NCT00006404|"     To evaluate the role of maternal diet and birth weight in the etiology of childhood asthma     and other allergic disorders.   "
165623|NCT00006371|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as     aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones.     Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective     treatment for prostate cancer.      PURPOSE: Phase II trial to study the effectiveness of combining hydrocortisone with either     aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate     cancer.   "
165624|NCT00006372|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating     patients who have advanced solid tumors.   "
165625|NCT00006373|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     autologous bone marrow transplantation or peripheral stem cell transplantation in treating     patients who have non-Hodgkin's lymphoma or Hodgkin's lymphoma.   "
165626|NCT00006374|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is more effective for treating     extensive-stage small cell lung cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of combining topotecan and     paclitaxel with that of combining etoposide and cisplatin in treating patients who have     extensive-stage small cell lung cancer.   "
165627|NCT00006375|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of LY293111 in treating patients who have     advanced solid tumors.   "
165628|NCT00006376|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have     advanced bladder cancer.   "
165629|NCT00006377|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin, paclitaxel, and     carboplatin in treating patients who have primary stage III, stage IV, or recurrent     endometrial cancer.   "
165630|NCT00006378|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells      PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens     of combining paclitaxel and carboplatin plus radiation therapy in treating patients who have     stage III non-small cell lung cancer that cannot be removed during surgery.   "
165631|NCT00006379|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may be able to replace     immune cells that were destroyed by chemotherapy used to kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     peripheral stem cell transplantation in treating patients who have hematologic cancer or     aplastic anemia.   "
165632|NCT00006380|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have prostate cancer that no longer responds to antiandrogen therapy.   "
165633|NCT00006381|"     RATIONALE: Celecoxib may be effective in preventing the further development of cancer.     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Combining trastuzumab     with celecoxib may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and trastuzumab in     treating women who have metastatic breast cancer that has not responded to previous     trastuzumab.   "
165634|NCT00006382|"     RATIONALE: New imaging procedures such as spiral CT may improve the ability to detect lung     cancer in patients who are at high risk for the disease.      PURPOSE: Randomized clinical trial to compare the effectiveness of a spiral CT scan with that     of a chest x-ray in detecting lung cancer in patients who are at high risk for the disease.   "
165635|NCT00006383|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of liposomal vincristine in treating     patients who have refractory or relapsed non-Hodgkin's lymphoma.   "
165636|NCT00006384|"     RATIONALE: SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor.     Interferon alfa-2b may interfere with the growth of the cancer cells. Combining interferon     alfa-2b with SU5416 may be an effective treatment for kidney cancer.      PURPOSE: Phase II trial to study the effectiveness of combining SU5416 and interferon alfa-2b     in treating patients who have unresectable or metastatic kidney cancer.   "
165637|NCT00006385|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Biological therapies such as sargramostim and interferon alfa use different ways to stimulate     the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy     if more effective with or without biological therapy for melanoma.      PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or     without biological therapy in treating patients who have metastatic melanoma.   "
165638|NCT00006386|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by     carmustine in treating patients who have supratentorial glioblastoma multiforme.   "
165657|NCT00006405|"     To determine whether a one year afternoon exercise program will reduce adiposity in African     American girls, ages 8 to 10.   "
165640|NCT00006388|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     tamoxifen may make the tumor cells more sensitive to radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with     tamoxifen in treating patients who have newly diagnosed supratentorial glioblastoma     multiforme.   "
168284|NCT00043797|"     This clinical trial is to determine an effective dosage and to study the safety of an     investigational drug -lidorestat (IDD-676)- which is intended to stop or slow the progression     of diabetic peripheral neuropathy.   "
165641|NCT00006389|"     Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients     who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different     ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase     the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining     cisplatin with bryostatin 1 may kill more tumor cells.   "
165642|NCT00006390|"     RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Peripheral     stem cell transplantation may be able to replace immune cells that were destroyed by     chemotherapy or radiation therapy. Combining monoclonal antibody therapy, chemotherapy,     radiation therapy, and peripheral stem cell transplantation may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of alemtuzumab plus peripheral stem cell     transplantation in treating patients who have chronic lymphocytic leukemia.   "
165643|NCT00006391|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin with topotecan in     treating patients who have previously treated ovarian epithelial, primary peritoneal, or     fallopian tube cancer.   "
165644|NCT00006392|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be     more effective in preventing prostate cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E,     either alone or together, in preventing prostate cancer.   "
165645|NCT00006393|"     OBJECTIVES: I. Determine whether defects in fibrillin-1 cellular processing are present in     the tsk1 mouse model that carries a known FBN1 gene rearrangement and in a population of     Choctaw Native American patients with systemic sclerosis who have a strong genetic     predisposition to the disease.      II. Determine the ultrastructural features of fibrillin-1 in these patients. III. Screen the     FBN1 gene for mutations beginning at the regions homologous to the tsk1 duplication and     latent transforming growth factor binding proteins in these patients and in an unaffected     Choctaw control group.      IV. Determine the correlation between fibrillin-1 abnormalities and clinical presentation,     autoantibodies, and ethnicity.   "
165646|NCT00006394|"     OBJECTIVES: I. Compare whether the bone tissue in the spine and hip improves in patients with     adult onset growth hormone deficiency treated with growth hormone (GH) vs placebo.      II. Determine whether the blood samples of these patients show evidence of beneficial bone     effects after treatment with GH.      III. Compare the quality of life of these patients treated with these 2 regimens.      IV. Determine the side effects of GH in these patients.   "
165647|NCT00006395|"     St. John's Wort is a popular dietary supplement that many patients-including those with     epilepsy or seizures-take in addition to their regular medicines to elevate mood or relieve     stress. Preliminary research indicates that this supplement can speed the metabolism of the     anti-seizure drug Tegretol, causing reduced blood levels of the drug. Patients who take     Tegretol to control their seizures may have more frequent seizures if the blood level of the     drug drops too low. A recent study shows that this effect is not seen when Tegretol is taken     for at least 3 weeks. The present study will examine whether there is a medically important     drug interaction between St. John's wort and Tegretol when Tegretol is taken for 1 day.      Normal healthy volunteers between 21 and 65 years old who are not taking medicines that can     affect the metabolism of drugs in the liver and have not used St. John's wort for at least 30     days may be eligible for this 25-day study.      Participants will take a 400-mg dose of Tegretol after fasting overnight. Blood samples will     be drawn the next day during a 12-hour clinic stay at the following intervals: just before     the Tegretol dose and at 1, 2, 4, 6, 8, 10, 24, 34, 48 and 72 hours after the dose. A     catheter will be placed in the vein to prevent the need for multiple needle sticks until     after the 10-hour sample. After completing the blood sampling, participants will take 300 mg     of St. John's wort 3 times a day with meals for 2 weeks. After 2 weeks, another fasting dose     of Tegretol will be given and the 72-hour blood study will be repeated.      This study may provide information important for the care of patients with epilepsy who take     both Tegretol and St. John's Wort.   "
165648|NCT00006396|"     The purpose of this study is to see if nevirapine (NVP) or zidovudine (AZT), given to mothers     during labor and delivery and to their babies during the first week of life, can reduce the     rate of mothers passing HIV to their babies.      About 25 percent of HIV-infected mothers pass HIV infection to their babies during labor and     delivery. There is an urgent need to find a simpler way to prevent mother-to-infant     transmission during labor and delivery. The proposed NVP schedule is simpler and possibly     could be used in Uganda.   "
165649|NCT00006397|"     The purpose of this study is to see how safe and effective it is to give multi-drug treatment     with indinavir (IDV) plus ritonavir (RTV) plus enteric-coated didanosine (ddI) plus stavudine     (d4T) and if there are differences in responses between men and women.   "
165650|NCT00006398|"     The purpose of this study is to learn whether timolol is useful in preventing or delaying the     appearance of gastroesophageal varices, a complication that may develop in the future as a     consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing     through the liver. This leads to an increased pressure in the portal vein (the vein that     takes blood to your liver). High portal pressure is responsible for the appearance of     complications of chronic liver disease such as varices and variceal bleeding (bleeding from     veins in your esophagus). Timolol belongs to a group of medications called beta-blockers.     Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker     pills are useful in preventing bleeding from varices in patients who already have varices. A     more desirable effect would be if these pills could prevent not only bleeding from varices     but the appearance of varices (and therefore of bleeding).   "
165651|NCT00006399|"     The goal of this study is to examine whether the administration of estrogen to     post-menopausal women and women with mild to moderate Alzheimer's disease will enhance their     memory and their capacity for learning.   "
165802|NCT00005608|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in     treating women who have metastatic breast cancer.   "
165662|NCT00006411|"     The Cornea Donor Study (CDS) was designed as a prospective cohort study with the following     objectives:      To determine whether the graft-failure rate over a 5-year follow-up period following corneal     transplantation is the same when using corneal tissue from donors older than 65 years of age     compared with tissue from younger donors.      To assess the relationship between donor/recipient ABO blood type compatibility and graft     failure due to rejection.      To assess corneal endothelial cell density as an indicator of the health of the cornea and as     a alternate outcome measure (in an optional Specular Microscopy Ancillary Study).   "
165663|NCT00006412|"     The purpose of this study is to compare the safety and effectiveness of fenofibrate and     pravastatin in treating HIV-positive patients who have abnormal levels of fat (lipids) in the     blood.      Increased lipids in the blood associated with HIV infection and anti-HIV drugs is a growing     problem. The drugs used in this study are known to reduce certain lipids, but little is known     about their safety and effectiveness. This study will see if one of the drugs is safer and     more effective than the other, or if combining the drugs is the safest and most effective way     to lower lipids. This study has been changed. On June 26, 2001, this study was reviewed by     the Data and Safety Monitoring Board (DSMB). The DSMB is an independent board monitoring the     progress of the study. The review showed that neither pravastatin nor fenofibrate alone were     effective in reaching all the cholesterol and triglyceride goals. There were no safety     concerns. It is not known if the combination of fenofibrate and pravastatin is effective and     safe. Therefore, it is important to continue this study.   "
165664|NCT00006413|"     This study will investigate the safety and effectiveness of an experimental stem cell     transplant procedure for treating mastocytosis-a disease of abnormal mast cell growth.     Patients often feel faint, have skin problems, joint and bone pain, low blood counts and     enlarged liver, spleen or lymph nodes. As yet, there is no cure for mastocytosis, and     treatment is aimed at controlling symptoms.      Stem cells are cells produced by the bone marrow that mature into the different blood     components-white cells, red cells and platelets. Transplantation of allogeneic (donated) stem     cells is a mainstay of therapy for some forms of leukemia. Patients first receive intensive     chemotherapy and radiation to rid the body of cancer cells. This conditioning is followed     by transplantation of donated stem cells to generate new, healthy bone marrow. In addition to     producing the new bone marrow, the donated cells also fight any residual tumor cells that     might have remained in the body. This is called a graft-versus-tumor effect. This study     will examine whether a stem cell transplant from a healthy donor can similarly target and     destroy mast cells in a graft-versus-mast cell effect. Also, to try to reduce the harmful     side effects of chemotherapy and radiation, this study will use lower dose chemotherapy and     no radiation.      Patients with advanced mastocytosis between 10 and 80 years old may be eligible for this     study. They will be      tested for HLA type matching with a sibling and will undergo a medical history, physical     examination and several tests to determine eligibility for the study.      Participants will undergo apheresis to collect lymphocytes (a type of white blood cell) for     immune function tests. In this procedure, blood is drawn through a needle in the arm, similar     to donating a unit of blood. The lymphocytes are then separated and collected by a cell     separator machine, and the rest of the blood is returned through a needle in the other arm.     Patients will also have a central venous line (flexible plastic tube) placed in their upper     chest leading to a vein. This line will remain in place throughout the transplant and     recovery period and will be used to transfuse blood components, administer medicines, infuse     the donated stem cells, and draw blood for tests. Patients will begin conditioning with     cyclophosphamide, starting 7 days before the transplant, and fludarabine, starting 5 days     before the transplant, to prevent rejection of the donated cells. From 1 to 3 days after the     chemotherapy is completed, the stem cells will be transfused through the central venous line.     Also, from 4 days before the transplantation until about 3 months after the procedure,     patients will receive cyclosporine and mycophenolate mofetil-drugs that help prevent both     rejection of the donated cells and attack by the donor cells on the patient's cells (called     graft-versus-host disease).      Patients will stay in the hospital about 20 to 30 days after the transplant. After discharge,     they will continue to take antibiotics, cyclosporine and mycophenolate mofetil at home. If     the mastocytosis progresses, cyclosporine and mycophenolate mofetil will be tapered over 4     weeks. If the mastocytosis persists, patients may receive additional transfusions of donor     lymphocytes to help kill the mast cells.      Patients' progress will be followed weekly or twice weekly for 3 months, then at 6, 12, 18,     24, 30, 36, 48 and 60 months after transplant, and then twice a year for various tests,     treatments and examinations.   "
165665|NCT00006414|"     This study will examine the effectiveness of an experimental treatment to improve hand     function in patients who have had a stroke affecting one side of the body. One of the main     problems of stroke patients is difficulty using the affected hand. Most treatments focus on     acute (early) intervention, although special exercises may help some chronic patients.     Previous studies have indicated that combining hand exercises with anesthesia (blocking motor     and sensory function) of the upper arm may improve hand movement in stroke patients, even in     the chronic state. This study will examine whether the exercise plus anesthesia treatment is     more beneficial for these patients over the long-term than exercise alone.      Patients 18 years or older who are at least 12 months post stroke, which has affected only     one side of the body, may be eligible for this study. Candidates will have a medical history     and physical and neurological examinations.      Participants will be randomly divided into two groups: one will practice hand exercises     without upper arm anesthesia and the other will exercise with anesthesia. All patients will     perform two consecutive sessions of 30-minute pinch practice-forceful pinching of the thumb     and index finger. Patients in the anesthesia group will have the anesthetic injected in the     lower neck. Enough anesthetic will be administered to block motor and sensory function in the     shoulder and upper arm, while maintaining as much function as possible in the forearm and     hand.      All patients will also have transcranial magnetic stimulation (TMS) testing. For this     procedure, a very brief electrical current is passed through an insulated wire coil placed on     the head, producing a magnetic pulse. The pulse travels through the scalp and skull and     causes small electrical currents in the outer part of the brain. During the study, the     patient will be asked to make movements, do simple tasks, or tense muscles, while the     electrical activity of the muscles is recorded.      Patients will have four sessions at 3-week intervals and three follow-up sessions at 3 weeks,     9 weeks and 24 weeks after the testing. Follow-up evaluations will include pinch power     testing, TMS, sensory function test and hand function measurement.   "
165666|NCT00005018|"     The purpose of this study is to see if it is safe and effective to give HIV-positive patients     a combination of anti-HIV drugs (abacavir [ABC] plus efavirenz [EFV] plus didanosine [ddI])     with and without hydroxyurea (HU).   "
165667|NCT00005020|"     The purpose of this study is to monitor patients who have recently been infected with HIV in     order to learn how their immune systems respond to HIV infection and to study how the virus     multiplies in their bodies.      Patients who have been infected with HIV recently are considered to have acute, or early, HIV     infection. During this period, viral load (level of HIV in the body) rises sharply to a high     level at first but then decreases significantly on its own. Doctors are not sure why this     decrease in viral load happens and how the body is able to accomplish this. In this study,     patients with acute HIV infection will be monitored so that doctors can study their immune     systems to try to learn more about this rise and fall in viral load.   "
165668|NCT00005021|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug, giving the drugs in different     ways, and combining biological therapy with chemotherapy may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of topotecan, paclitaxel, and carboplatin     with or without filgrastim in treating patients who have advanced solid tumor or lymphoma     that has not responded to standard therapy.   "
165669|NCT00005022|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus combination     chemotherapy in treating patients with limited-stage small cell lung cancer.   "
165670|NCT00005023|"     RATIONALE: Vaccines may make the body build an immune response to tumor cells.     Colony-stimulating factors such as sargramostim increase the number of immune cells found in     bone marrow or peripheral blood.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in     treating patients who have stage III or stage IV cancer.   "
165671|NCT00005024|"     RATIONALE: Antiemetic drugs such as granisetron may help to prevent nausea and vomiting in     patients treated with chemotherapy.      PURPOSE: Randomized phase III trial to compare the effectiveness of granisetron with that of     a placebo in preventing nausea and vomiting after chemotherapy in patients who have malignant     disease.   "
165672|NCT00005025|"     RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating women who have     refractory or relapsed ovarian epithelial cancer, fallopian tube cancer, or peritoneal     cancer.   "
165673|NCT00005026|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating     patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer.   "
165674|NCT00005027|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analog in treating     patients who have advanced kidney cancer.   "
165743|NCT00005512|"     To determine how genetic and environmental factors influence the co-occurrence of obesity and     hypertension during development and to identify cardiovascular risk factors in adolescence     that will predict cardiovascular disease in adults.   "
165675|NCT00005028|"     Phase II trial to study the effectiveness of combining paclitaxel and bryostatin 1 in     treating patients who have metastatic prostate cancer that has not responded to hormone     therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.   "
165676|NCT00005029|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients who have     recurrent ovarian epithelial or primary peritoneal cancer.   "
165677|NCT00005030|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase I trial to compare the effectiveness of different doses of SCH     66336 before surgery in treating patients who have colorectal cancer that has metastasized to     the liver.   "
165678|NCT00005031|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have     persistent or recurrent refractory endometrial cancer.   "
165679|NCT00005032|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Bcl-2 antisense oligodeoxynucleotide G3139 may increase the     effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.      PURPOSE: Phase I/II trial to study the effectiveness of bcl-2 antisense oligodeoxynucleotide     G3139 and paclitaxel in treating patients who have recurrent small cell lung cancer.   "
165680|NCT00005033|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who     have recurrent osteosarcoma.   "
165681|NCT00005035|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who     have advanced head and neck cancer.   "
165682|NCT00005036|"     Randomized phase III trial to compare the effectiveness of irinotecan with that of     combination chemotherapy in treating patients who have advanced colorectal cancer that has     not responded to previous treatment. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Combining more than one drug may kill     more tumor cells. It is not yet known which chemotherapy regimen is more effective for     colorectal cancer.   "
165683|NCT00005037|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who     have stage IIIB, stage IV, or recurrent non-small cell lung cancer.   "
165684|NCT00005038|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer     cells. Histamine dihydrochloride may prolong survival and improve quality of life in patients     with metastatic kidney cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of interleukin-2 with or     without histamine dihydrochloride in treating patients who have metastatic kidney cancer.   "
165685|NCT00005039|"     Randomized phase II trial to determine the effectiveness of vaccine therapy in treating     patients who have advanced adenocarcinoma of the prostate (prostate cancer). Vaccines made     from a person's prostate cancer cells may make the body build an immune response to kill     tumor cells   "
165686|NCT00005040|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have relapsed or refractory non-Hodgkin's lymphoma.   "
165687|NCT00005041|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have     relapsed small cell lung cancer.   "
165688|NCT00005042|"     RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the     tumor.      PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have     AIDS-related Kaposi's sarcoma.   "
165689|NCT00005044|"     RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may     fight prostate cancer by reducing the production of androgens. Radiation therapy uses     high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone     therapy and radiation therapy is more effective for prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of     hormone therapy and radiation therapy in treating patients who have prostate cancer.   "
165690|NCT00005045|"     RATIONALE: Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow     to the tumor.      PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole in treating     patients who have advanced kidney cancer that has not responded to biological therapy.   "
165691|NCT00005046|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of paclitaxel in treating patients who have     recurrent or persistent ovarian or primary peritoneal cancer.   "
165692|NCT00005047|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether combination chemotherapy is more effective than observation alone in     treating bladder cancer.      PURPOSE: This randomized phase III trial is studying combination chemotherapy to see how well     it works compared to observation alone in treating patients with bladder cancer.   "
165693|NCT00005048|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining estramustine and paclitaxel in     treating patients who have prostate cancer that has not responded to hormone therapy.   "
166881|NCT00009867|"     Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have     recurrent cancer of the bladder or urinary tract. Arsenic trioxide may kill tumor cells that     have become resistant to standard chemotherapy regimens.   "
165694|NCT00005049|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving them by intraperitoneal     infusion may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of intraperitoneal combination     chemotherapy in treating patients who have stage III ovarian epithelial cancer or     gastrointestinal cancer.   "
165695|NCT00005050|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining eniluracil, fluorouracil,     and oxaliplatin in treating patients who have advanced colorectal cancer that has been     treated previously.   "
165696|NCT00005051|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have advanced ovarian epithelial cancer.   "
165697|NCT00005052|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not     yet known whether vaccine therapy is more effective than observation alone for melanoma.      PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works     compared to observation alone in treating patients with primary stage II melanoma.   "
165698|NCT00005053|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Hydration with a saline solution may protect kidney cells from the     side effects of chemotherapy.      PURPOSE: Randomized phase II trial to compare the effectiveness of glufosfamide with or     without hydration in treating patients who have pancreatic cancer that is metastatic or     cannot be removed by surgery.   "
165699|NCT00005054|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating women who have     advanced breast cancer.   "
165700|NCT00005055|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Hydration with saline solution may protect kidney cells from the     side effects of chemotherapy.      PURPOSE: Randomized phase II trial to study the effectiveness of glufosfamide with or without     hydration in treating patients who have advanced non-small cell lung cancer.   "
165701|NCT00005056|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who     have progressive kidney cancer   "
165702|NCT00005057|"     RATIONALE: Inserting a modified herpesvirus gene into a person's melanoma cells may make the     cancer more sensitive to the antiviral agent ganciclovir.      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who     have stage IV melanoma.   "
165703|NCT00005058|"     RATIONALE: New imaging procedures, such as enhanced ultrasound may improve the ability to     determine the extent of breast cancer.      PURPOSE: Diagnostic study of enhanced ultrasound in women who have locally advanced primary     breast cancer.   "
165704|NCT00005059|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating     patients who have metastatic or recurrent unresectable non-small cell lung cancer.   "
165705|NCT00005473|"     To test hypotheses related to gender differences in cardiovascular mortality trends between     1980 and 1991 in two southeastern New England communities which were part of the Pawtucket     Heart Health Program.   "
165706|NCT00005474|"     To elucidate the biochemical, metabolic, and genetic markers and mechanisms of macrovascular     disease in insulin dependent diabetes mellitus (IDDM).   "
165707|NCT00005475|"     To extend follow-up of a birth cohort of asthmatic children through adolescence and on to     adulthood. .   "
165708|NCT00005476|"     To establish the aspects of ethnicity that are associated with the differential expression of     cardiovascular disease processes in African Americans and Caucasian Americans twin children.   "
165709|NCT00005477|"     To elucidate the influence of ethnicity and socioeconomic status (SES) on women's     cardiovascular health, using recently completed risk factor and mortality data from the     Stanford Five-City Project.   "
165710|NCT00005478|"     To elucidate the changes in body size, composition, and configuration occurring in     adolescence, because these are important precursors of change in blood pressure and blood     lipids.   "
165711|NCT00005479|"     To better understand the excess cardiovascular disease associated with diabetes mellitus.   "
165712|NCT00005480|"     To elucidate the interrelationship of level of cardiovascular disease knowledge and     subsequent clinical health status by merging population-based cardiovascular disease risk     factor survey data with patient-level hospital data. The overall goal was to assess outcomes     in the positive/negative association between level of cardiovascular disease knowledge and     incidence and relative degree of morbidity among a cohort with and without major     cardiovascular disease risk factors.   "
165713|NCT00005481|"     To determine the nature, extent and molecular mechanisms responsible for impaired     fibrinolysis in White, Black, Hispanic and American Indian populations with respect to the     presence or absence of diabetes. The overall objective is to determine whether impairments of     fibrinolysis underlie subclinical and clinical vascular disease in diabetes in specific     populations with and without accelerated microvascular disease.   "
165714|NCT00005482|"     To test the hypotheses that the risk of myocardial infarction and/or stroke is associated     with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12     and B6.   "
165744|NCT00005513|"     To examine hypotheses concerning the relationships between nutrient intake (in particular,     specific fatty acids, antioxidant nutrients, and B vitamins), dietary patterns, plasma     lipoproteins, and heart disease endpoints in the population-based Framingham Offspring     Studies.   "
167623|NCT00030030|"     To investigate the effect of silymarin, derived from the milk thistle plant, Silybum     marianum, in preventing and reversing the complications of chronic infection with hepatitis C     virus and/or clearing hepatitis C infections.   "
165715|NCT00005483|"     To describe the distribution of homocysteine and prevalence of hyperhomocysteinemia with     emphasis on race, sex and age. To determine the extent to which hyperhomocysteinemia is     associated with status of folate and vitamin B12. Finally, to describe the relationships     between prevalence of hyperhomocysteinemia and prevalence of cardiovascular disease and     assess the importance of this risk factor as a cause of vascular disease among US adults. The     study was renewed for one year to investigate normal homocysteine concentrations among     children and to identify nutritional and non-nutritional determinants of total homocysteine     concentrations in children.   "
165716|NCT00005484|"     To identify clinical predictors of episodes of hospital-based care in people with asthma.   "
165717|NCT00005485|"     This is a prospective study of the environmental and genetic factors that influence the     development of cardiovascular disease (CVD) in African American men and women. The cohort is     an expansion of the Jackson, Mississippi site of the Atherosclerosis Risk in Communities     (ARIC) study and is a partnership among two minority institutions (Jackson State University     and Tougaloo College), one majority institution in Jackson, Mississippi (the University of     Mississippi Medical Center), the National Institutes of Health (NIH) National Center on     Minority Health and Health Disparities (NCMHD), and the National Heart, Lung, and Blood     Institute (NHLBI).   "
165718|NCT00005486|"     To establish a registry of individuals with LAM by forming a consortium of six clinical     centers and referring physicians who treat LAM patients.   "
165719|NCT00005487|"     To conduct a prospective observational study of the characteristics of subclinical     cardiovascular disease (disease detected non-invasively before it has produced signs and     symptoms) that predict progression to clinically overt cardiovascular disease in a diverse     and representative population-based sample of men and women aged 35-84. Specifically the     study shall: determine characteristics related to progression of subclinical to clinical     cardiovascular disease; identify factors related to newer measures of subclinical disease and     examine relationship of new to established measures; and develop population-based methods,     suitable for application in future screening and intervention studies, for identifying     asymptomatic persons at highest risk of clinical events.   "
165720|NCT00005488|"     To examine the impact of an interaction between common genetic susceptibility markers and     environmental exposures on risk for early onset myocardial infarction in cases with     myocardial infarction and matching controls.   "
165721|NCT00005489|"     To identify the role of salt-sensitivity of blood pressure in the pathogenesis of     hypertension.   "
165722|NCT00005490|"     To identify and measure DNA sequence variation in 13 genes that play a central role in key     physiological functions involved in the development of cardiovascular disease, that is, genes     involved in lipid metabolism, carbohydrate metabolism, and blood pressure regulation.   "
165723|NCT00005492|"     To conduct a pooled analysis of NHANES I/II data on race, gender, and coronary heart disease.   "
165724|NCT00005493|"     To analyze existing data from the Physicians Health Study (PHS), a randomized primary     prevention trial of low-dose aspirin and beta carotene conducted among 22,071 U.S. male     physicians, to address questions concerning aspirin and cardiovascular (CV) disease that     could not adequately be addressed during the randomized aspirin period.   "
165725|NCT00005494|"     To compare rates of coronary heart disease (CHD), cancer, total mortality and exercise     injuries in 68,000 runners and 68,000 walkers during four years of surveillance   "
165726|NCT00005495|"     To evaluate the effectiveness of primary prevention of coronary heart disease risk factors by     examining data from the National Health Examination Survey (NHES) and the National Health and     Nutrition Examination Surveys (NHANES) to determine whether more recent birth cohorts were     attaining lower blood pressure and cholesterol levels than earlier birth cohorts.   "
165727|NCT00005496|"     To examine markers of underlying chronic inflammation and infection as potential risk factors     for future myocardial infarction (MI), stroke (CVA), and venous thromboembolism (VTE) in     plasma samples collected at baseline from healthy participants in the Physicians' Health     Study (PHS).   "
165728|NCT00005497|"     To conduct a multicenter case-control study of persistent pulmonary hypertension of the     newborn (PPHN) in relation to maternal exposure to smoking and non-steroidal     anti-inflammatory drugs (NSAIDs). Also, to assess other potential antenatal risk factors and     collect and store buccal cell specimens for future analyses.   "
165729|NCT00005498|"     To test the hypothesis that high levels of hostility, depressive symptoms, and stressful life     events would be associated with all cause and cardiovascular disease (CVD) mortality after 16     years of follow-up in the Multiple Risk Factor Intervention Trial (MRFIT).   "
165730|NCT00005499|"     To investigate trends in the incidence and survival rates of congestive heart failure (CHF)     in two successive cohorts of elderly people (1970-74, 1990-94) in a health maintenance     organization (HMO).   "
165731|NCT00005500|"     To conduct molecular genetic studies in human pedigrees in order to identify the major genes     responsible for asthma.   "
165732|NCT00005501|"     To determine the impact of the treatment of hypertension on the epidemiological analyses of     blood pressure from observational studies.   "
165733|NCT00005502|"     To study the entire population of Olmsted County, Minnesota, including all age categories, to     examine the secular trends in coronary heart disease (CHD) mortality, myocardial infarction     (MI) incidence, and natural history, including MI severity, case fatality and post-MI     morbidity. Also, to examine the time trends in the prevalence of CHD at post-mortem because     of the uniquely high autopsy rate in Olmsted County.   "
165734|NCT00005503|"     To document normal developmental changes in cardiac structure and function during late     childhood and adolescence.   "
165735|NCT00005504|"     To investigate venous thromboembolism in two carefully conducted prospective epidemiologic     studies of African American and white adults -- the Atherosclerosis Risk in Communities     (ARIC) Study and the Cardiovascular Health Study (CHS).   "
165736|NCT00005505|"     To investigate the contributions of neighborhood environments to the distribution of     cardiovascular disease (CVD) risk across different age ranges and racial/ethnic groups, using     data from three ongoing cohort studies of cardiovascular disease: the Coronary Artery Disease     Risk Development in Young Adults (CARDIA) Study, the Atherosclerosis Risk in Communities     (ARIC) Study, and the Cardiovascular Health Study (CHS).   "
165745|NCT00005514|"     To study, prospectively, the association between dietary patterns and risk of coronary heart     disease (CHD), ischemic stroke, and hemorrhagic stroke in cohort studies of 121,700 women age     30 to 55 years at baseline in 1976 (the Nurses; Health Study; NHS) and 51,529 men aged 40-75     years at baseline in 1986 (the Health Professionals Follow-up Study; HPFS).   "
165746|NCT00005515|"     To assess the interaction between hormone replacement therapy and the prothrombotic     mutations, Factor V Leiden and the recently described prothrombin mutation (20210A) on the     incidence of venous thromboembolism (VTE) in a population-based case-control study conducted     at Group Health Cooperative of Puget Sound (GHC).   "
165747|NCT00005516|"     To collect fundamental data regarding the distribution of measures of sleep disordered     breathing (SDB) in a pediatric population, prevalence of clinically significant SDB in     children, risk factors, and associated co-morbidity.   "
165748|NCT00005517|"     To conduct a surveillance study of congestive heart failure (CHF).   "
165749|NCT00005518|"     To determine the risk factors associated with inhibitor formation in hemophilia A and to     study the mechanism of tolerance in the murine hemophilia A model.   "
165750|NCT00005551|"     To investigate the causes, consequences and quantitation of sleep disordered breathing (SDB).   "
165751|NCT00005552|"     To characterize the skin route of exposure to the allergen hexamethylene diisocyanate (HDI)     in the auto body industry.   "
165752|NCT00005553|"     To evaluate children undergoing catheter ablation at pediatric centers in North America in     order to provide information on the incidence rate of serious cardiac damage as a result of     ablation, the incidence rate and time course of recurrence after initially successful     ablation, and the incidence rate of proarrhythmia following ablation.   "
165753|NCT00005554|"     To examine some of the psychosocial predictors of poor outcome among revascularized coronary     artery disease patients.   "
165754|NCT00005555|"     To determine the minimal dose of physical activity necessary to improve cardiovascular (CV)     health by evaluating and aerobically training 500 healthy men and women, 30-65 years of age.   "
165755|NCT00005556|"     To identify factors that affected the National Marrow Donor Program's (NMDP) success in     retention of bone marrow volunteers.   "
165756|NCT00005557|"     To characterize the natural history and biologic spectrum of sleep disordered breathing (SDB)     and other sleep problems and disorders, and test hypotheses regarding the causes and     consequences of SDB and other sleep problems and disorders.   "
165757|NCT00005559|"     To determine optimal values for transferrin saturation for use in population screening for     hereditary hemochromatosis.   "
165758|NCT00005560|"     To determine if there are anatomic and physical characteristics that distinguish     pre-adolescent children with sleep disordered breathing and if the sleep disordered breathing     is associated with adverse effects on school and neurocognitive performance.   "
165759|NCT00005562|"     To investigate coronary artery calcium (CAC), detected by electron beam computed tomography     (EBCT), as a predictor of coronary heart disease (CHD) mortality and morbidity, stroke, and     all-cause mortality in a historical cohort epidemiological study.   "
165760|NCT00005563|"     To study the epidemiology of emergency asthma by focusing on three Multicenter Asthma     Research Collaboration (MARC) databases collected over a two-year period in adult and     pediatric emergency departments.   "
165761|NCT00005564|"     To assess the separate and interactive effects of asthma severity, subspecialty practice     variation, asthma-related psychosocial variables, and other factors on asthma outcomes,     including asthma-specific quality of life and activity limitations, health care utilization     for asthma, and direct and indirect costs of asthma.   "
165762|NCT00005565|"     To determine mechanisms of low levels of apolipoprotein B.   "
165763|NCT00005566|"     The purpose of this project is to pilot a new scale, The Desperation Scale, in a sample of     young adolescents (aged 10-16) seen in the pediatric emergency room who require a psychiatric     consultation. The proposed study is designed to assess the psychometric properties of this     new scale and to provide information about the cognitive state of young suicidal individuals.     It is hypothesized that this scale will be able to discriminate between those who are     suicidal and those who are not. Data obtained in this pilot study will provide information     about the usefulness of the construct of desperation and will guide future projects aimed at     the assessment and treatment of suicidal individuals. The use of cognitive factors to predict     suicidal behavior is appealing because they allow the clinician to tap into an individual's     perception of his/her life circumstances. However, we believe the popular conceptualization     of suicide as a result of hopeless thinking ignores an important aspect of suicidal     behavior-the motivation to escape. We propose that a model of suicidal behavior that includes     escape motivation, which we call the desperation model, will be better able to predict     suicide than existing measures. We conceptualize desperation as consisting of three core     elements: a sense of entrapment, feelings of anxiety/agitation, and a sense of time urgency.     The current pilot study will test a 35-item scale that assesses these three elements of     desperation. A pilot study of the Desperation Scale is currently being conducted at the     Cornell University Medical Center (P.I. P.M. Marzuk) with depressed, adult inpatients. Our     study is original in its use of the scale with an adolescent population and its focus on     patients in the emergency room, when they are presumably in a purer suicidal state. It is     hypothesized that those who are admitted to the emergency room for recent suicidal behavior     will endorse feelings of entrapment, anxiety, and time urgency.   "
165764|NCT00005567|"     In the United States, Sudden Infant Death Syndrome (SIDS)is the leading cause of death in     infants between the ages of 1 and 12 months. The etiology of SIDS is still not clear although     a number of risk factors have been identified. Sleeping on the stomach has been identified as     a major risk for SIDS. The rates of SIDS have dropped substantially in countries in which the     usual sleep position has changed from the stomach to the side or back. Back sleep has been     shown to be the most stable and safest position. The American Academy of Pediatrics now     recommends the back sleeping position for all healthy infants. Since the American Academy of     Pediatrics began advocating the back sleep position, the incidence of SIDS has decreased by     more than 40% in this country. However, the decrease has not been uniform across segments of     the population. Black infants continue to have a higher rate of SIDS compared with other     groups. This discrepancy could be related to infant sleep position practices. Several studies     have shown that infants born to low income, minority, inner-city families were more likely to     be placed on the stomach to sleep. Education appears to influence choice of sleep position     and may explain, at least to some degree, the difference in choice of sleep position among     certain groups. We believe that uniform education of parents will influence the sleep     position that parents choose for their baby. We will undertake this initial study to document     what parents choose to do with their infants regarding sleep position and why they make these     choices so that we can improve our educational approach.   "
165765|NCT00005569|"     This study will evaluate the effects of a protein called secretory leukocyte protease     inhibitor (SLPI), on skin wound healing. Produced naturally by the body, SLPI modifies levels     of elastase, a substance that breaks down the skin. Older people are at greater risk of     impaired wound healing, with increased elastase activity and inflammation. In addition, men     heal more slowly than women. Delayed healing is associated with infection and pain and can     lead to the development of chronic non-healing skin wounds.      Healthy men and women between 60 and 80 years old who wish to participate in this study will     have a brief history and physical evaluation to determine their eligibility. Those enrolled     will be randomly assigned to receive a gel form of SLPI applied topically (on the skin     surface) to a skin wound or a placebo (a look-alike gel with no active ingredient).     Participants will undergo the following procedures:      First visit - The skin will be numbed with a local anesthetic and two small (4 mm) wounds     (about the size of a pencil eraser) made in each upper arm. The drug or placebo will be     applied to the wound and gauze placed over it. Two blood samples (20 ml and 7 ml) will be     drawn an hour apart to determine blood levels of SLPI.      Second visit - The day after the first visit, the wound dressing will be removed and the     participant will be evaluated for pain at the wound site, allergic reactions or infection. A     blood sample (7 ml) will be taken.      Third visit - The wounds will be examined and photographed to evaluate healing. In addition,     the strength of the wound may be assessed by means of a vacuum system placed on the skin.     (This may cause a tingling sensation over the wound.) A piece of all four wounds will be     removed after the skin has been numbed and a dressing applied.      Fourth visit - The wounds will be examined for healing and the dressing removed.   "
165766|NCT00005570|"     This study involves the collection of blood samples from patients with immune     thrombocytopenic purpura (ITP) to evaluate the relationship between platelet counts, blood     levels of a hormone called thrombopoietin that controls platelet production by the bone     marrow, and blood levels of antibodies against thrombopoietin that could interfere with the     action of this hormone. Blood samples will also be stored if separately agreed to by the     patient for analysis of genes that might affect platelet production. At a single outpatient     clinic visit, patients will have a medical history taken, and blood samples drawn for     testing. Results from this study may help further understand the control of platelet     production in patients with ITP, and suggest new therapeutic approaches.   "
165767|NCT00005571|"     This study will evaluate the safety and effectiveness of the experimental drug h5G1.1-mAb in     treating patients with dermatomyositis. This disease, which causes skin rash, muscle     weakness, and sometimes various other symptoms, may be due to an immune system abnormality.     Drugs currently used to treat dermatomyositis, such as prednisone and various anticancer     drugs, often have serious side effects and may not work in all patients. h5G1.1-mAb is a     genetically engineered antibody that blocks the activity of certain proteins involved in the     immune reaction that produces inflammation.      Patients age 18 years and older who have had dermatomyositis for at least 6 months and who     have not improved with prednisone or other therapies, or who cannot tolerate prednisone or     other therapies, may be eligible for this 12-week study. Candidates will have a history and     physical examination, including blood and urine tests, throat culture, and muscle strength     testing. Participants will be randomly assigned to receive either h5G1.1-mAb or placebo (an     inactive substance). The drug or placebo will be given intravenously (through a thin tube     inserted into a vein) once a week for five doses and then every other week for two more     doses.      Participants will undergo the following additional tests at various intervals during the     study as follows:        1. Complete physical examination ( visit 9)        2. Blood and urine tests (various intervals)        3. Muscle strength testing, assessment of ability to perform daily tasks, and completion of          questionnaire regarding functional abilities (visits 2, 6 and 9)        4. Ultrasound imaging of muscle (during certain muscle exercises) (visits 2, 6 and 9)        5. Electrocardiogram (EKG) (visits 2 and 9)        6. Throat swab (culture) (visit 6)        7. Examination and photography of skin lesions (visits 2 and 9)        8. Skin biopsy - removal of small sample of skin tissue under local anesthetic (visits 2          and 9)        9. Magnetic resonance imaging (MRI) scan of muscles (visits 2 and 9)       10. Possible muscle biopsy - removal of small sample of muscle tissue under local anesthetic          (visits 2 and 9).   "
165768|NCT00005572|"     The purpose of this study is to understand how changes in the immune system of HIV-infected     patients affect their risk for 3 serious infections: Pneumocystis carinii pneumonia (PCP),     cytomegalovirus (CMV) retinitis, or CMV organ disease. The purpose also is to understand how     anti-HIV medicines may improve the immune system in these patients. (This purpose reflects a     change in the AIDS-related [opportunistic] infections studied.) Presently, HIV-infected     patients who have had PCP or CMV disease stay on lifelong therapy to prevent the return of     the disease. This study is trying to see if a special lab test can help identify which     patients can stop this preventive therapy without having another episode of PCP or CMV organ     disease. (This rationale reflects a change in the AIDS-related infections studied.)   "
165769|NCT00005574|"     This study will evaluate the antibiotic gentamicin for treating patients with muscular     dystrophy caused by a specific genetic abnormality known as a nonsense mutation. In studies     of mice with this type of muscular dystrophy, gentamicin treatment produced positive changes     in muscle tissue.      Patients with Duchenne or Becker muscular dystrophy caused by nonsense mutations by may be     eligible for this 2-week study. Before starting treatment, patients will have evaluations of     muscle strength and general well being. Two muscle tissue samples will be taken by needle     biopsy, under local anesthetic and sedation. Because of potential risks of hearing loss and     kidney toxicity associated with gentamicin, patients will also have a hearing test and blood     and urine tests for kidney function before starting treatment. (Currently, gentamicin is     commonly prescribed for serious infections of the lungs, heart, and digestive and urinary     tracts; adverse effects of hearing loss and kidney toxicity can occur with excessively high     drug doses.)      Patients will be hospitalized during drug treatment. Gentamicin will be given intravenously     (through a vein) once a day for 14 days. Blood samples will be collected daily to monitor     drug levels and determine dosage adjustments, if necessary. Urine samples will be collected     to assess kidney function. Hearing tests will be done on days 7 and 10.      On the last day of the study, hearing, kidney function, and muscle strength will be tested     and the results compared with pre-treatment levels. Blood and muscle samples will also be     taken again for pre-treatment comparison. Hearing, blood, urine, and muscle strength tests     will be repeated one month after treatment ends for comparison with previous results.   "
165770|NCT00005575|"     Approximately 75,000-150,000 patients each year in the United States undergo intensive     cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings.     These patients often have high levels of disability and suffering and account for     $250,000,000-$500,000,000 in estimated health care costs each year. There is some evidence     from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of     training in pain coping skills and cognitive-behavioral therapy (CBT) both produce short-term     reductions in pain intensity. However, no studies have compared the effects of these two     treatments on measures of pain, suffering, and disability at post-treatment and over a     one-year follow-up period.      Our investigation is a 16-week, randomized controlled outcome study of these interventions     and their respective placebo control procedures. One hundred and sixty patients are being     recruited for this study. We will assess the effects of our interventions on patients' pain     levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month     follow-up, and at 12-month follow-up. We will evaluate the clinical significance of our     treatment effects as well as their statistical significance.   "
165771|NCT00005576|"     Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing     substances to them without harming normal cells. Colony-stimulating factors such as     sargramostim may increase the number of immune cells found in bone marrow or peripheral     blood. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.     Combining monoclonal antibody therapy with sargramostim or interleukin-2 may kill more tumor     cells. Phase I trial to study the effectiveness of monoclonal antibody therapy given with     sargramostim and interleukin-2 in treating children with neuroblastoma who have just     completed bone marrow or peripheral stem cell transplantation   "
165772|NCT00005577|"     Phase I trial to study the effectiveness of gemcitabine in treating children who have     refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die.   "
165773|NCT00005578|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal     cells from the side effects of chemotherapy.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without dexrazoxane in treating children who have Hodgkin's disease.   "
165774|NCT00005579|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with     indolent lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia.   "
165775|NCT00005580|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in     treating patients who have chronic lymphocytic leukemia or relapsed, indolent non-Hodgkin's     lymphoma.   "
165776|NCT00005581|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which regimen of chemotherapy is more effective for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of     combination chemotherapy in treating women who have stage II or stage III breast cancer.   "
165777|NCT00005583|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether radiation therapy with chemotherapy is more effective than     radiation therapy alone in treating high-risk endometrial cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy and chemotherapy to     see how well they work compared to radiation therapy alone in treating patients with     high-risk endometrial cancer.   "
165778|NCT00005584|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not     yet known which combination chemotherapy regimen is most effective in treating Hodgkin's     lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of     combination chemotherapy with or without radiation therapy in treating patients who have     Hodgkin's lymphoma.   "
165779|NCT00005585|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known which regimen of combination chemotherapy is more effective for childhood acute     lymphoblastic leukemia.      PURPOSE: This randomized phase III trial is comparing different regimens of combination     chemotherapy to see how well they work in treating children with acute lymphoblastic     leukemia.   "
165780|NCT00005586|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether chemotherapy is more effective than observation in patients who have had     surgery to remove colorectal cancer.      PURPOSE: This randomized phase III trial is studying leucovorin and fluorouracil to see how     well they work compared to observation in treating patients with colorectal cancer that has     been surgically removed.   "
165781|NCT00005587|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known which regimen of radiation therapy is more effective following surgery for breast     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of radiation     therapy following surgery in treating women who have early stage breast cancer.   "
165782|NCT00005588|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known which regimen of radiation therapy is more effective following surgery for breast     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of     radiation therapy following surgery in treating women who have early stage breast cancer.   "
165783|NCT00005589|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to     give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies     such as rituximab can locate cancer cells and either kill them or deliver cancer-killing     substances to them without harming normal cells. It is not yet known if combination     chemotherapy plus peripheral stem cell transplantation is more effective with or without     rituximab for non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and     peripheral stem cell transplantation together with rituximab to see how well it works     compared to combination chemotherapy and peripheral stem cell transplantation alone in     treating patients with relapsed non-Hodgkin's lymphoma.   "
165784|NCT00005590|"     RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection     in patients receiving chemotherapy for solid tumors or lymphoma. It is not yet known if     levofloxacin if effective in preventing infection.      PURPOSE: Randomized phase III trial to determine the effectiveness of levofloxacin in     preventing infection in patients receiving chemotherapy for solid tumors or lymphoma.   "
165821|NCT00005629|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients     who have liver cancer.   "
165785|NCT00005591|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cell from dividing so they stop growing or die.     Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of cetuximab plus gemcitabine in treating     patients who have locally advanced, metastatic, or recurrent cancer of the pancreas.   "
165786|NCT00005592|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radiation to     them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab and ibritumomab tiuxetan in     treating patients who have relapsed or refractory non-Hodgkin's lymphoma.   "
165787|NCT00005593|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of fludarabine, carboplatin, and topotecan     in treating patients who have relapsed or refractory acute leukemia or advanced     myelodysplastic syndrome.   "
165788|NCT00005594|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have     advanced cancer of the pancreas.   "
165789|NCT00005595|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have relapsed or refractory Hodgkin's disease.   "
165790|NCT00005596|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known which regimen of chemotherapy is more effective for acute lymphoblastic     leukemia.      PURPOSE: This randomized phase III trial is comparing four regimens of combination     chemotherapy to see how well they work in treating children with newly diagnosed acute     lymphoblastic leukemia.   "
165791|NCT00005597|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who     have unresectable or metastatic gastrointestinal stromal tumors.   "
165792|NCT00005598|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Amifostine may improve blood counts in patients with     myelodysplastic syndrome. Combining azacitidine with amifostine may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of azacitidine plus amifostine in treating     patients who have myelodysplastic syndrome.   "
165793|NCT00005599|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 and paclitaxel in treating     patients who have locally advanced or metastatic esophageal cancer or stomach cancer.   "
165794|NCT00005600|"     RATIONALE: The use of axillary drains may help to prevent complications following axillary     lymph node dissection.      PURPOSE: This randomized clinical trial is comparing three methods of axillary drainage to     see how well they work following lymph node dissection in women with stage I or stage II     breast cancer.   "
165795|NCT00005601|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer     cells and either kill them or deliver cancer-killing substances to them without harming     normal cells. Combining combination chemotherapy with monoclonal antibody therapy may kill     more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab     in treating patients who have relapsed non-Hodgkin's lymphoma.   "
165796|NCT00005602|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.      PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with     carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.   "
165797|NCT00005603|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from     dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more     cancer cells. It is not yet known which combination chemotherapy regimen is more effective     for acute lymphoblastic leukemia.      PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy in     treating children who have newly diagnosed acute lymphoblastic leukemia.   "
165798|NCT00005604|"     Phase I trial to study the effectiveness of interleukin-12 plus interleukin-2 in treating     patients who have advanced solid tumors. Interleukin-12 may kill tumor cells by stopping     blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells.     Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining the     two drugs may kill more cancer cells   "
165799|NCT00005605|"     RATIONALE: Tamoxifen may be able to increase bone density and decrease cholesterol in women     who are undergoing chemotherapy for breast cancer.      PURPOSE: Clinical trial to study the effectiveness of tamoxifen in preventing bone loss and     heart disease caused by chemotherapy treatment in premenopausal women who have stage I or     stage II breast cancer.   "
165800|NCT00005606|"     RATIONALE: Peripheral blood lymphocyte therapy may be effective in the treatment and     prevention of Epstein-Barr virus infection following transplantation.      PURPOSE: Phase II trial to study the effectiveness of peripheral blood lymphocyte therapy in     treating and preventing lymphoproliferative disorders in patients who have Epstein-Barr virus     infection following transplantation.   "
165801|NCT00005607|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have metastatic or recurrent cancer of the stomach or esophagus.   "
165840|NCT00005648|"     The purpose of this study is to compare the effectiveness of gemcitabine with or without     tipifarnib (R115777) in patients who have advanced pancreatic cancer.   "
165803|NCT00005609|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have     Waldenstrom's macroglobulinemia.   "
165804|NCT00005610|"     RATIONALE: Colony-stimulating factors, such as sargramostim, may help the body's immune     system to kill cancer cells. Giving sargramostim in different ways may kill more cancer     cells.      PURPOSE: Phase II trial to study the effectiveness of sargramostim given as a breathing     treatment for treating patients who have melanoma that is metastatic to the lung.   "
165805|NCT00005611|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of BMS-188797 in treating patients who have     advanced solid tumors that have not responded to previous treatment.   "
165806|NCT00005612|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with autologous peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by     peripheral stem cell transplantation in treating patients who have ovarian epithelial cancer.   "
165807|NCT00005613|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with allogeneic or autologous peripheral     stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and     kill more cancer cells.      PURPOSE: Phase II trial to compare the effectiveness of allogeneic stem cell transplantation     with that of autologous peripheral stem cell transplantation in treating patients who have     non-Hodgkin's lymphoma or Hodgkin's disease.   "
165808|NCT00005614|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating elderly women     who have metastatic breast cancer.   "
165809|NCT00005615|"     RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Radiation therapy     uses high-energy x-rays to damage tumor cells. Combining interferon alfa plus radiation     therapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa plus radiation     therapy in treating patients who have stage III or recurrent melanoma that has been removed     by surgery.   "
165810|NCT00005616|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have colorectal cancer.   "
165811|NCT00005617|"     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill     tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients     who have stage IV, or relapsed malignant melanoma.   "
165812|NCT00005618|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have relapsed or refractory chronic myelogenous leukemia.   "
165813|NCT00005619|"     RATIONALE: Diagnostic procedures that detect residual disease may predict disease relapse in     patients who have hairy cell leukemia.      PURPOSE: Diagnostic trial to determine the effectiveness of analyzing blood and bone marrow     to detect residual disease in patients who have previously treated hairy cell leukemia.   "
165814|NCT00005622|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow     transplant helps stop the growth of cancer cells. It also helps stop the patient's immune     system from rejecting the donor's stem cells. When the stem cells from a related or unrelated     donor, that closely matches the patient's blood, are infused into the patient they may help     the patient's bone marrow to make stem cells, red blood cells, white blood cells, and     platelets.      PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in     treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.   "
165815|NCT00005623|"     RATIONALE: Cyproterone acetate may be effective treatment for hot flashes following surgical     or chemical castration for prostate cancer. It is not yet known which regimen of cyproterone     acetate is more effective for hot flashes.      PURPOSE: Randomized phase III trial to determine the effectiveness of cyproterone acetate in     treating patients who have hot flashes following surgical or chemical castration for prostate     cancer.   "
165816|NCT00005624|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of CI-994 in treating patients who have     advanced myeloma.   "
165817|NCT00005625|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients     who have previously treated metastatic osteosarcoma.   "
165818|NCT00005626|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who     have newly diagnosed or relapsed non-Hodgkin's lymphoma or leukemia.   "
165819|NCT00005627|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of estramustine, docetaxel, and carboplatin     in treating patients who have prostate cancer that has not responded to hormonal therapy.   "
165820|NCT00005628|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients     who have recurrent soft tissue sarcoma.   "
165822|NCT00005630|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Colony-stimulating factors such as sargramostim may increase the number of immune cells found     in bone marrow or peripheral blood.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy and sargramostim in     treating patients who have non-small cell lung cancer.   "
165823|NCT00005631|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer     cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy     in treating patients who have relapsed or refractory large cell lymphoma.   "
165824|NCT00005632|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining     a vaccine with QS21 may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus immune adjuvant     QS21 in treating patients who have prostate cancer.   "
165825|NCT00005633|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with stage III or stage IV melanoma.   "
165826|NCT00005634|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in     treating patients who have advanced primary or metastatic solid tumors that have not     responded to previous therapy.   "
165827|NCT00005635|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of two different regimens of     trastuzumab plus paclitaxel in treating women who have metastatic breast cancer that     overexpresses HER2.   "
165828|NCT00005636|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if cisplatin is more effective with or without     pemetrexed disodium for malignant mesothelioma of the pleura.      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without     pemetrexed disodium in treating patients who have malignant mesothelioma of the pleura that     cannot be removed by surgery.   "
165829|NCT00005637|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor     cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following     radiation therapy in treating patients who have malignant glioma.   "
165830|NCT00005638|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus radiation therapy in     treating patients who have advanced cancer of the esophagus.   "
165831|NCT00005639|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine plus     phenylbutyrate in treating patients with advanced or metastatic solid tumors that have not     responded to previous treatment.   "
165832|NCT00005640|"     RATIONALE: Diagnostic procedures, such as lymph node mapping and biopsy, may improve the     ability to detect the extent of colorectal cancer.      PURPOSE: Diagnostic trial to study the feasibility of lymph node mapping and sentinel lymph     node biopsy in patients who have stage I, stage II, or stage III colorectal cancer.   "
165833|NCT00005641|"     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Eliminating the T cells from the donor cells before transplanting them may prevent this from     happening.      PURPOSE: Phase II trial to study the effectiveness of T cell removal to prevent     graft-versus-host disease in patients who are undergoing bone marrow transplantation from a     donor.   "
165834|NCT00005642|"     RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor.      PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have     advanced solid tumors.   "
165835|NCT00005643|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating     patients who have advanced or recurrent sarcoma of the uterus.   "
165836|NCT00005644|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have advanced cancer of the urothelium with decreased kidney function.   "
165837|NCT00005645|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ILX-295501 in treating patients who     have stage III or stage IV ovarian cancer that has not responded to previous therapy.   "
165838|NCT00005646|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who     have extensive-stage small cell lung cancer.   "
165839|NCT00005647|"     RATIONALE: SU5416 may stop the growth of head and neck cancer by stopping blood flow to the     tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating     patients who have recurrent, locally advanced, or metastatic cancer of the head and neck.   "
165841|NCT00005649|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel and capecitabine in treating     women who have metastatic breast cancer.   "
165843|NCT00005652|"     OBJECTIVES: I. Determine the response rate and response duration to rituximab in patients     with immune thrombocytopenic purpura.      II. Evaluate the toxicity associated with this treatment regimen in these patients.      III. Evaluate the alteration in antiplatelet antibody with this treatment regimen in these     patients.   "
165844|NCT00005654|"     OBJECTIVES:      I. Determine whether reduction of serum insulin levels by metformin increases ovulatory     response to clomiphene or spontaneous ovulation in obese women with polycystic ovary     syndrome.   "
165845|NCT00005655|"     The purposes of this study are fourfold. It will 1) determine what dose of interleukin-12     (IL-12) and interleukin-2 (IL-2) combination therapy can be given safely to patients with     advanced cancer; 2) evaluate the side effects of this treatment; 3) examine how the body     handles this drug combination; and 4) determine whether and how the therapy may cause the     immune system to stop or slow tumor growth.      IL-2 is an approved drug for treating melanoma and kidney cancer. IL-12 is an experimental     drug that has shown anti-cancer activity in animals, shrinking tumors and slowing their     growth. Animal studies suggest that given together, the drugs may be more effective against     cancer than either one singly.      Patients 18 years of age and older with advanced solid-tumor cancers (kidney, breast, lung,     sarcomas and others) that do not improve with standard treatment may qualify for this study.     Candidates will have a physical examination, including blood and urine tests,     electrocardiogram (EKG) and echocardiogram, DTH skin test (to test the function of the immune     system), chest X-ray and lung function tests to determine eligibility. Bone marrow biopsy and     imaging procedures such as CT and MRI scans may also be required. Patients over 50 years old     will also undergo exercise stress testing.      Treatment will consist of four courses of IL-2 and IL-12. On days one and nine of each     course, patients will receive three doses (one every 8 hours) of IL-2 intravenously (through     a vein). On days two, four, six, 10, 12 and 14, they will receive IL-12 intravenously. This     will be followed by a recovery period from days 15 through 35. This regimen will be repeated     for another three cycles; patients who show benefit without severe side effects may continue     for additional cycles. Treatment for the first cycle will be administered in the hospital. If     the drugs are well tolerated, additional therapy may be given on an outpatient basis.      A biopsy (removal of a small sample of tumor tissue) will be done at the beginning of the     study, after completing the first treatment cycle, and possibly again when the cancer slows,     stops or gets worse, or if the patient leaves the study. These tumor samples will be examined     to evaluate the effects of treatment. Several blood samples also will be collected during the     course of treatment to monitor immune system effects. A device called a heparin lock may be     put in place to avoid multiple needle sticks.   "
165846|NCT00005657|"     The diverse clinical syndromes associated with hepatitis C underscore the multifactorial and     polygenic nature of HCV infection. Both viral and host factors likely contribute to     variations in infection outcome, disease susceptibility and progression, and treatment     response. This protocol will focus on the immunogenetics of HCV infection. Various candidate     genes, most of them related to host immune response in microbial infection, have defined     genetic polymorphisms that have been associated with variable manifestations of infections     including malaria, tuberculosis, leprosy, AIDS and hepatitis B. In this proposal, we plan to     collect peripheral blood mononuclear cells as a source of DNA from approximately 1500     patients with HCV infection, analyze genetic polymorphisms of various candidate genes in     association with viral clearance, disease progression or treatment response, and characterize     the functional consequences of these polymorphisms in patients with well-defined clinical     sequelae of HCV infection. We will also collect blood from patients with other forms of liver     diseases (approximately 300) or normal volunteers (approximately 200) as controls. By     identifying relevant host factors genetically and investigating their molecular interactions     with HCV, we may gain additional insights into HCV pathogenesis and uncover new potential     targets for vaccine development and treatment intervention.   "
165847|NCT00005658|"     This study will test the safety and effectiveness of the amino acid glycine in treating     psychotic disorders in children. The drug will be given as an adjunct (in addition) to the     patient's current antipsychotic medication.      Children age nine to 18 with schizophrenia or schizoaffective disorder whose symptoms began     before age 13 may be eligible for this 10-week study. Patients will be hospitalized during     the course of the trial. Weekend visits home may be permitted.      Children enrolled in the study will be evaluated during a two-week pre-treatment period with     written tests for IQ and academic functioning and with a magnetic resonance imaging (MRI)     scan of the brain. For the MRI, the child lies on a table that slides into a large     donut-shaped machine with a strong magnetic field. This procedure produces images of the     brain that may help identify brain abnormalities in schizophrenia that develop in childhood.      During the eight-week treatment phase, patients will receive glycine powder dissolved in     water once a day, in addition to their other antipsychotic medications. They will undergo the     following additional procedures during the course of treatment:        1. Comprehensive psychiatric examination        2. Blood pressure and pulse monitoring once a week        3. Blood tests every other week - About one ounce of blood is drawn per week to measure          glycine levels        4. Eye movement study at week eight - Using a technique called infrared oculography,          special detectors measure infrared light reflected off the child's eyes while he or she          watches a moving square on a video monitor.        5. Lumbar puncture (spinal tap) once during the study - About one-half ounce of          cerebrospinal fluid (the fluid surrounding the brain and spinal cord) is withdrawn          through a needle placed in the lower part of the spine for analysis of brain chemicals.      Patients who respond well may continue to receive glycine treatment through their referring     physician after the study is completed.      NIMH will follow patients by phone every six months and with visits at two-year intervals.   "
165848|NCT00005660|"     This is a continuing study which evaluates the long-term safety and efficacy of oral     acitretin in an open manner in the treatment of psoriasis, cutaneous disorders of     keratinization, multiple basal cell carcinomas and other retinoid responsive diseases.   "
165849|NCT00005663|"     The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective     treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and     external genitals) in HIV-infected patients.   "
165850|NCT00005664|"     This study will evaluate patients with a variety of endocrine disorders in order to 1) learn     more about conditions that affect the endocrine glands (glands that secrete hormones) and 2)     to train physicians in endocrinology.      Patients of all ages with endocrine-related conditions may be eligible for evaluation under     this protocol. Those enrolled may be required to provide blood, saliva, urine or stool     samples, and to undergo ultrasound examination of the thyroid gland, ovaries or testes,     adrenal glands or other parts of the body. Laboratory or X-ray studies may be done for     diagnostic or treatment purposes. In some cases, patients will receive medical or surgical     treatment for their disorder. Patients and family members of patients with a hereditary     disorder may be asked to provide a blood sample for genetic analysis.   "
165873|NCT00005689|"     To provide a comprehensive description of smoking beliefs and behavior among rural Blacks,     and to test the effectiveness of smoking cessation strategies delivered through Black     churches.   "
165876|NCT00005692|"     To determine inflammation markers over time in cardiovascular disease. To test the hypothesis     that measures of coagulation and fibrinolysis correlate with the incidence of coronary heart     disease (CHD) and other thrombosis related disorders, and to help identify those individuals     at greatest risk, using the Cardiovascular Health Study (CHS) and Honolulu Heart Program     (HHP) populations. These two genetically distinct populations had different event rates for     CHD, and offered a unique opportunity to test associations that were uncovered by comparing     results across populations.   "
165851|NCT00005665|"     We hypothesize that ingested human recombinant interferon-alpha (hrIFN-a) will prolong the     honeymoon period and enhance B cell survival in type 1 diabetes in a phase II randomized,     placebo-controlled, double-blind clinical trial. We have demonstrated that ingested IFN-a     prevents type 1 diabetes in the NOD mouse, prolongs the honeymoon period in newly diagnosed     type 1 diabetics, and delays murine islet allograft rejection. The natural history of type 1     diabetes is unique for a phase frequently referred as the honeymoon, a period in which the     insulin need becomes minimal and glycemic control improves. The B cell (the insulin producing     cell) partially recovers. However, as with all honeymoons, they end and the patient becomes     completely insulin-deficient. The general consensus of the international diabetes community     is to test potential preventive therapies for type 1 diabetes in newly diagnosed patients.     Prolongation of the honeymoon as the reversal of the disease is considered a positive result.      In this phase II randomized, double-blind, parallel-design clinical trial we will determine     whether ingested (oral) human recombinant IFN-a will prolong the honeymoon period and     increase counterregulatory anti-inflammatory cytokine(s).      We will determine the safety and efficacy of 30,000 units ingested hrIFN-a vs placebo in     eighty patients with newly diagnosed type 1 diabetes in a phase II trial for one year.     Primary outcome measures will be a 30% increase in C-peptide levels released after Sustacal     stimulation at 3, 6, 9, and 12 months after entry. Secondary outcome will be decreasing     titers of islet cell antibodies (ICA). If successful, a larger and longer phase III trial of     prevention of type 1 diabetes in high risk patients will be undertaken. We will also     determine if ingested hrIFN-a increases IL-4, IL-10 or IFN-a production in peripheral blood     mononuclear cells (PMNC) from patients with recent onset type 1 diabetes.   "
165852|NCT00005666|"     This is a research study for patients with inoperable lung cancer called non-small cell lung     cancer (NSCLC). Currently, the information from a radiological test, computed tomography (CT)     scan of the chest, is used to design the best arrangement of radiation beams which will kill     tumor cells and still spare the normal parts of lungs and other normal organs in the chest.     The purpose of this study is to explore whether adding information from another radiological     test, called positron emission tomography (PET), will improve the accuracy of the radiation     beam arrangement designed to treat lung cancer. A PET scan is a way to picture the     biochemistry of tissues and organs: of how tissues in the body take up glucose, a normal     nutrient of the body. The researchers will attempt to create radiation treatment plans from     PET images alone and compare differences between hypothetical plans and standard-of-care     CT-based radiation treatment plans. Because there is honest uncertainty about the     contribution of PET to radiation treatment planning, it is possible that there will be no     difference between a CT-based treatment plan and one resulting from PET information. It is     also possible that the addition of PET may result in a radiation beam arrangement that may     better control lung cancer. The addition of PET may also result in treating less normal     tissues, which may lower the risk of radiation side effects. This study will provide the     preliminary data necessary to design a larger clinical trial that may define the role of PET     in radiation treatment planning.   "
165853|NCT00005667|"     Enterococci, especially vancomycin resistant enterococci (VRE), are increasing in prevalence     in many hospitals in the United States. Patients undergoing liver transplantation are at     particular risk for developing infection due to VRE. The effect of prior colonization with     VRE on the outcome of liver transplantation is unknown. This prospective study will ascertain     the prevalence of gastrointestinal colonization with vancomycin resistant enterococci among     patients awaiting liver transplantation at the University of Michigan Health System. Risk     factors for acquisition of the organism, natural history of colonization and outcome in     colonized patients will also be determined. All patients currently listed on a priority     waiting list for liver transplantation at UMHS will be invited to participate. Patients will     receive a standardized letter from their primary gastroenterologist describing the rationale     for the study. Patients will be contacted by telephone by a member of the study team in order     to arrange an appointment in the GCRC at the time of their regularly scheduled Transplant     Clinic appointment in order discuss their potential participation in the study. Patients who     give informed consent, will be interviewed using a standard interview questionnaire.     Demographic and historical data relevant to the risk of VRE colonization will be collected     during the interview. A sample will be obtained via rectal swab for culture. Rectal swabs for     culture and collection of information on the standardized questionnaire will be repeated     every six months while the patient is awaiting liver transplantation. When a patient     undergoes liver transplantation, a culture will be obtained at the time of admission and     weekly after post-operatively until discharge. All patients will be followed for 60 days     after transplantation to assess several primary outcomes, including operative and     post-operative complications, VRE infection and mortality. Rectal swabs will be the only     procedure performed for the purposes of this study. Culture results will not be made     available to the transplant team in order to avoid bias in clinical care. All data will be     entered into an electronic database. GCRC statisticians will assist in the analysis of risk     factors and outcome analysis.   "
165854|NCT00005668|"     To compare the safety and effectiveness of itraconazole oral solution to placebo in the     treatment of a pulmonary aspergilloma.      Aspergilloma is a fungal ball in the lungs caused by Aspergillus. The infection can spread     from the lungs through the blood to other organs. Aspergilloma can be life-threatening;     therefore, an effective treatment is needed.   "
165855|NCT00005669|"     This study will examine the safety and effectiveness of the medicine metformin to help     overweight children control their food intake, weight, insulin, cholesterol, and triglyceride     (blood fat) levels. Obesity and high insulin levels can lead to high blood pressure,     diabetes, high cholesterol and triglyceride levels and heart disease. Metformin-approved by     the Food and Drug Administration to treat adults with type 2 diabetes mellitus-helps lower     insulin levels and may control weight gain in adults.      Overweight children 6 to 11 years old who are in general good health may be eligible for this     study. Children will be studied at the National Institutes of Health in Bethesda, Maryland.     Candidates will have a medical history and physical examination and fasting blood test, and     will provide a 7-day record of their food intake as part of the screening process. Those     enrolled will be randomly assigned to receive either metformin or placebo (a look-alike     tablet with no active medicine) twice a day for a six month period. After the 6 month study     period, all children will be offered the opportunity to take metformin for another 6 months.      Participants will be hospitalized for 2-3 days for the following procedures: history and     physical examination; fasting blood test; several urine collections; X-ray studies to     determine bone age and amount of body fat and muscle; magnetic resonance imaging (MRI) scan     to measure body fat; hyperglycemic clamp study to evaluate insulin resistance; food intake     testing; nutrition consultation; resting metabolic rate; and a doubly labeled water test.      For the hyperglycemic clamp study, a catheter (thin flexible tube) is inserted into a vein in     each arm. A sugar solution is given through one tube and blood samples are drawn every 5     minutes through the other to measure insulin. For the food intake testing, the child is asked     about his or her hunger level, then given various foods he or she may choose to eat, then     questioned again at various intervals both during and after finishing eating about his or her     hunger level. The doubly labeled water study involves drinking heavy water (water which is     enriched to have special kinds of hydrogen and oxygen). Urine specimens are collected 2, 3     and 4 hours after drinking the water. The child also drinks a special milk shake called a     Scandishake and repeats the calorie intake and hunger study. (Two food intake studies are     done on separate days.) One week after the heavy water test, additional urine samples are     collected one week later.      After completing the tests, the child will begin treatment with metformin or placebo, plus a     daily vitamin tablet. Participants will be followed once a month with a brief history and     physical examination, including a blood test. After 6 months, all of the tests described     above will be repeated. All children who complete the second round of tests-both those who     took metformin and those who took placebo-will be offered metformin for an additional 6     months and will be seen once a month for follow-up evaluations. Parents will not be told     which children received metformin and which received placebo until all children in the study     complete the first 6 months of the trial.   "
165856|NCT00005671|"     This study will examine the health-related quality of life in patients being treated for     chronic heart disease.      Patients 18 years or older with chronic ischemic heart disease and left ventricular     dysfunction enrolled in protocols in the National Heart Lung and Blood Institute's Cardiology     Branch may participate in this study.      Participants will complete five questionnaires at 3 separate times during the study-once     during hospitalization at the NIH Clinical Center and again at home 6 months and 1 year     later. The questionnaires, described below, require a total of about 30 minutes to complete.        1. Demographic Information Sheet -General information such as age, marital status,          employment, education, and history of cardiac medical procedures.        2. General Health Survey -Patient's self-assessment, on a rating scale, of physical and          emotional well being. Questions are related to the ability to perform work and daily          living activities, mood and state of mind, limitations on social activities, energy          level, pain level, general quality of life, etc.        3. Heart Disease Survey - Patient's self-assessment, on a rating scale, of the level of          physical, social, emotional and functional well being related to his or her heart          condition. Questions concern fatigue level, emotional outlook, social well being, etc.        4. Angina Survey - Information on the frequency of chest pain, chest tightness, or angina.        5. Symptom Distress Survey - Patient's ranking of the degree of symptom distress from chest          discomfort, difficulty breathing, heart rate irregularities, wheezing and coughing.      All information provided in the questionnaires will be kept confidential. Upon request,     patients will be sent a summary of the study results when the study is completed.   "
165874|NCT00005690|"     Among patients undergoing elective primary coronary artery bypass graft (CABG), the principal     objective of this randomized trial was to compare the efficacy of two strategies of     intra-operative hemodynamic management during cardiopulmonary bypass in preventing     peri-operative cardiac, cognitive and neurologic morbidity and mortality, and post-operative     deterioration in patients' quality of life as measured by the SF-36.   "
165875|NCT00005691|"     To study psychosocial risk factors for coronary heart disease in Swedish women.   "
165901|NCT00005717|"     To test the effectiveness of a self-management program for chronic obstructive disease (COPD)     patients. The program to improve adherence could be conducted by nurses or other clinic staff     in settings where comprehensive rehabilitation services were not available.   "
165857|NCT00005673|"     This 2-part study will test the safety and anti-HIV activity of capravirine alone, and the     safety, anti-HIV activity, and drug interactions of capravirine combined with other anti-HIV     drugs. Capravirine belongs to a class of drugs called non-nucleoside reverse transcriptase     inhibitors (NNRTIs), which are effective when used together with other drugs, including     nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitors.      Normal volunteers 18 years of age and older may enroll in Part 1 of the study. HIV-infected     patients 18 years of age and older who have not previously been treated with a NNRTI     (efavirenz, nevirapine, and delavirdine) may participate in Part 2. All prospective study     participants will be screened for eligibility with a physical examination, blood tests, a     urine test and an electrocardiogram (ECG).      Part 1 - Volunteers will be randomly assigned to one of two treatment groups as follows:      Group 1 will receive capravirine alone for 7 days and capravirine plus efavirenz (another     NNRTI) for an additional 10 days. On day 1, participants will have a physical examination,     urine test and laboratory blood tests. Blood samples will be collected just before the first     dose of capravirine is given and again at 0.5, 1, 2, 4, 6, 8 and 12 hours after the dose. A     small plastic tube will be placed in a vein to avoid multiple needle sticks. On day 8,     participants will have another physical examination and laboratory blood tests. Blood samples     will be drawn again as described above. In the evening of day 8, efavirenz will be added to     the regimen. On day 18 (the last day of the study), participants will have another physical     examination and blood tests. Blood will again be collected as described above.      Group 2 will take capravirine alone for 8) days and capravirine plus ritonavir (a protease     inhibitor) for an additional 8 days. Physical examinations, urine tests, and blood     collections will be done as described above on day 1, day 8 and day 16 (the last day) of the     study.      Part 2 - Patients will take capravirine alone for 7 days. On day 1, patients will have a     physical examination, urine test and laboratory blood tests. Blood samples will be collected     just before the first dose of capravirine is given and again at 0.5, 1, 2, 4, 6, 8 and 12     hours after the dose. A small plastic tube will be placed in a vein to avoid multiple needle     sticks. On day 8, patients will have another physical examination and laboratory blood tests.     Blood samples will be drawn again as described above. Additional drugs will then be added to     the regimen (in varying doses according to group), as follows:      Group 1 - efavirenz plus abacavir      Group 2 - ritonavir plus efavirenz plus abacavir      Group 3 - ritonavir plus efavirenz plus abacavir      On day 15, the procedures performed on day 8 will be repeated.      Patients will have the option of having blood drawn daily on days 2 through 7 to measure     HIV-1 viral load and of having a lumbar puncture (spinal tap) done between days 2 and 7 to     measure how well capravirine gets into the central nervous system.      After day 15, patients in all groups will continue with their drug regimen until week 48 or     until it is determined that the treatment is not effective for the patient. Physical     examinations, viral load measurements, white blood cell counts and other blood tests will be     done periodically throughout the trial. Within 4 weeks after the end of the study, patients     will be followed with another physical examination, blood and urine tests, and an ECG.   "
165858|NCT00005674|"     The purpose of this study is to evaluate the safety and effectiveness of creatine treatment     in amyotrophic lateral sclerosis (ALS). There is currently no known effective treatment for     ALS. It is known that nerve cells die in the brains and spinal cords of patients with ALS but     the cause of the cell death is unknown. It has been shown that there is overactive nerve     activity due to increased levels of a chemical called glutamate and that there is abnormal     cellular metabolism along with increased production of substance called free radicals.     Improving cellular metabolism and readjusting the activity of glutamate in the brain may be     beneficial to ALS patients.      Creatine is a naturally occurring compound, which improves energy metabolism in cells.     Creatine has been given to patients with energy metabolism defects in their muscles, and to     athletes. Creatine improves survival in a mouse model of ALS. Three human subjects with ALS     have received creatine for up to six months without any side effects. Overall, creatine has     been well tolerated and safe.   "
165859|NCT00005675|"     Diffuse systemic sclerosis (SSc), or scleroderma, is a connective tissue disease causing     damage to skin and other organs. The purpose of this study is to determine if taking oral     bovine type I collagen (CI) will improve the condition of SSc patients.   "
165860|NCT00005676|"     To investigate the relative contributions of high density lipoprotein-C (HDL-C) subspecies to     risk for coronary heart disease (CHD) in two distinct existing populations (samples from the     VA-HIT study and the Framingham Offspring Study [FOS]) as well as the response of these     subfractions to gemfibrozil treatment.   "
165861|NCT00005677|"     To evaluate the long-term efficacy of percutaneous transluminal coronary angioplasty (PTCA)     and alternative angioplasty devices in patients with coronary heart disease. There are four     registries. The first registry followed 3,079 patients who received PTCA between 1977 and     1982. The second registry followed 1,500 patients from the first registry for a minimum of     five years and followed 2,000 newly entered patients who received PTCA in 1985 and 1986 so     that the second cohort would also be followed for five years. The third registry, the New     Approaches to Coronary Intervention (NACI), followed approximately 4,424 patients between     November 1990 and February 1997. The dynamic evaluation study will follow a total of 6,000     procedures.   "
165862|NCT00005678|"     To foster collaboration between the World Health Organization MONICA Project and the NHLBI     Study of Atherosclerosis Risk in Communities (ARIC). To ensure that valid comparisons could     made between findings in MONICA and ARIC by supporting activities to standardize coding,     classification, and analysis of coronary and stroke events, risk factors, and medical care     according to MONICA protocol.   "
165863|NCT00005679|"     To conduct a multicenter prevalence survey for characterizing pathologically the extent of     atherosclerosis in the aortas and coronary arteries of young persons dying from accidental     causes, suicide, or homicide.   "
165864|NCT00005680|"     To examine the effect on health and disease of the work environment, psychological workload,     control over work pacing and content, opportunity for use of skills, social support at work;     the moderating effect on these relationships of social supports; and, the interaction between     these psychosocial factors and other established risk factors in the etiology of chronic     disease.   "
165865|NCT00005681|"     To test the hypothesis that the aggressive treatment of plasma LDL and oxidized LDL will     result in improvements in the activity of ischemia in patients with coronary artery disease     and will reverse characteristic cell/vessel wall dysfunctions in the arteries of these     patients.   "
165866|NCT00005682|"     To conduct incidence and case-control studies of aplastic anemia in metropolitan Bangkok,     Thailand   "
165867|NCT00005683|"     To conduct clinical interventions directed at neonatal lung disease and injury, with a focus     on infants having surfactant-deficiency or inactivation as a component of pathophysiology. A     major emphasis was on the surfactant-deficient Respiratory Distress Syndrome (RDS) of     premature infants, and on acute neonatal respiratory failure in term infants with pulmonary     edema and potential surfactant inactivation (ARDS-related).   "
165868|NCT00005684|"     To perform a randomized clinical trial comparing continuing one month of treatment with     heparin in patients with deep venous thrombosis to standard care using heparin for five days     and oral warfarin for three months.   "
165869|NCT00005685|"     To examine racial and psychosocial influences on blood pressure control.   "
165870|NCT00005686|"     To develop a dietary intervention method that was capable of producing large sustained weight     losses and was thus suitable for use in clinical trials related to obesity.   "
165871|NCT00005687|"     To study the process of recycling failed smoking cessation attempts and relapses.   "
165872|NCT00005688|"     To investigate the differential diagnosis and longitudinal course of medical outpatients     complaining of palpitations. Also, to further examine the process of cardiac perception, the     psychological factors which influence it, and the accurate awareness of cardiac arrhythmias.   "
165908|NCT00005724|"     To develop cardiovascular disease nutrition modules tailored to subjects with low literacy     skills.   "
165877|NCT00005693|"     To develop and evaluate a computer assisted instruction (CAI) weight management program in an     adult population with low literacy at Sheehan Memorial Hospital's Family Care Center (FCC),     an outpatient clinic serving the inner city of Buffalo, New York.   "
165878|NCT00005694|"     To study the relative effectiveness of teaching occupational nurses to conduct cholesterol     screening, counseling and referral events (SCOREs) in their own worksites versus using an     external organization to implement these programs. Also. to study the relative effectiveness     of face-to-face behavior change counseling following the cholesterol measurement versus     automated feedback of essentially the same individualized educational material.   "
165879|NCT00005695|"     To determine the effects of physical activity on blood pressure and body fat in children     varying in ethnicity, gender, and health status.   "
165880|NCT00005696|"     To complete end point analysis for the Monitored Atherosclerosis Regression Study (MARS) and     to compare coronary versus carotid treatment effect relationships in MARS to coronary versus     carotid treatment effect relationships in the Cholesterol Lowering Atherosclerosis Study     (CLAS). Both MARS and CLAS were serial arterial imaging trials that explored the     reversibility of atherosclerosis with lipid-lowering therapy in native coronary, carotid, and     femoral arterial beds, as well as in coronary artery bypass grafts.   "
165881|NCT00005697|"     This 31-month supplement to Sustaining Women's Smoking Cessation Postpartum (Project PANDA)     designed, implemented, and evaluated an intensified intervention for pregnant women who were     unable to stop smoking with minimal assistance.   "
165882|NCT00005698|"     To implement and evaluate with a randomized, controlled trial interventions to improve     control of hypertension among inner city low- income and minority residents of Seattle.   "
165883|NCT00005699|"     To conduct a community based education program using existing resources to improve     hypertension control in the inner city through multiple interventions.   "
165884|NCT00005700|"     To conduct a randomized controlled trial to evaluate the effectiveness of an intervention to     reduce dietary fat.   "
165885|NCT00005701|"     To conduct a series of five inter-related studies on acute cardiac ischemia (ACI) in women.   "
165886|NCT00005702|"     To experimentally test methods to promote long-term smoking cessation in hospitalized     patients.   "
165887|NCT00005703|"     To assess in older children and adults with sickle cell disease (SCD) whether intrinsic     activation (relevant to the origin of pain and acute inflammation) occurs only during     vasocclusive crisis (VOC).   "
165888|NCT00005704|"     To test pharmacologic intervention for smoking postcessation weight gain using nicotine gum     and phenylpropanolamine (PPA).   "
165889|NCT00005705|"     To evaluate three adherence promoting interventions within the Childhood Asthma Management     Program (CAMP), an eight center clinical trial that compared pediatric asthma therapies in     children five to twelve years old.   "
165890|NCT00005706|"     To investigate whether a health education program, developed in partnership with the     community and delivered by nurse supervised community health workers (CHWs), lowered high     blood pressure (HBP) in inner city African American adults.   "
165891|NCT00005707|"     To improve long-term blood pressure BP) control in a predominantly African-American, low SES     community of a large city.   "
165892|NCT00005708|"     To develop effective strategies for enhancing adherence to therapeutic interventions designed     to improve care for hypertensive minority populations.   "
165893|NCT00005709|"     To study relationships among lipoprotein metabolism, hypertension, and     hyperinsulinemia-insulin resistance in African American males and females. The study was part     of a Collaborative Project on Minority Health which investigated the mechanisms by which     insulin contributes to cardiovascular disease.   "
165894|NCT00005710|"     To develop and to test a brief telephone intervention following clinic treatment for smoking     cessation.   "
165895|NCT00005711|"     To design, implement, and evaluate an intervention program for Hispanic children with asthma     which included both a physician education and a patient/family education component.   "
165896|NCT00005712|"     To evaluate the effects of a new statewide program to enhance identification, referral and     provision of care to rural families of Hispanic children with moderately severe to severe     asthma. Specifically, to determine if comprehensive medical care (CMC) plus an educational     self-management program for rural Hispanic children and their families had an impact on     asthma morbidity, as well as on cost and family adaptation.   "
165897|NCT00005713|"     To demonstrate that the New York City Department of Health Child Health Clinics could improve     the health status of Black and Hispanic children with asthma by providing them with a     comprehensive system of continuity of care that included pharmacologic treatment, family     health education and community outreach.      Recent studies have shown that lack of continuing primary care for asthma is associated with     increased levels of morbidity in low-income minority children. Although effective preventive     therapy is available, many African-American and Latino children receive episodic treatment     for asthma that does not follow current guidelines for care. To see if access, continuity,     and quality of care could be improved in pediatric clinics serving low-income children in New     York City, we trained staff in New York City Bureau of Child Health clinics to provide     continuing, preventive care for asthma.   "
165898|NCT00005714|"     To evaluate a community organization approach to promoting asthma management in four     neighborhoods in St. Louis with predominantly low income, Black populations.   "
165899|NCT00005715|"     To test the effectiveness of school-based asthma education interventions, community-based     asthma health workers' programs and the combination of these on asthmatic children. Also, to     examine the separate and combined impact of asthma interventions designed to address problems     associated with effective asthma self-management amd difficulties in establishing and     maintaining continuity of medical care.   "
165906|NCT00005722|"     For State Health Departments located in Stroke Belt states, to assess high risk target     audiences' needs and identify opportunities for more effective delivery of medical and/or     educational services to reduce the high rate of stroke mortality experienced in the     southeastern United States.   "
165907|NCT00005723|"     To evaluate the impact of organizational-level health promotion activities and worksite     characteristics on employee dietary and smoking behaviors.   "
165909|NCT00005725|"     To develop and demonstrate the efficacy of a set of original, cardiovascular (CVD) nutrition     education materials designed to reduce intake of sodium (Na) fat, and cholesterol and which     would be appropriate for urban Black adults with 5th to 8th grade reading levels.   "
165910|NCT00005726|"     To develop and evaluate a nutrition education program to reduce cardiovascular disease risk     in persons with low literacy skills.   "
165911|NCT00005727|"     To conduct a randomized, controlled trial of cardiovascular disease nutrition education using     a cluster design with two conditions, special intervention (SI) and usual care (UC).   "
165912|NCT00005728|"     To utilize a community-based approach to nutrition education in an urban African American     community.   "
165913|NCT00005729|"     To promote cardiovascular health through nutritional education in a low literacy population     enrolled in English as a Second Language (ESL) courses in the San Diego Community College     District.   "
165914|NCT00005730|"     To serve as a focal point for bone-marrow research.   "
165915|NCT00005731|"     To develop and implement asthma-controlling educational strategies for inner city and high     risk populations.   "
165916|NCT00005732|"     To develop and implement asthma controlling strategies for inner city and high risk     populations.   "
165917|NCT00005733|"     To develop and implement asthma controlling strategies for inner city and high risk     populations.   "
165918|NCT00005734|"     To implement and evaluate a comprehensive asthma education and prevention program in all 54     public elementary schools in the predominantly minority Birmingham, Alabama school system.   "
165919|NCT00005735|"     To implement and evaluate a coordinated set of activities for asthma identification,     education, management, and prevention in the predominantly minority inner city schools in the     Detroit metropolitan area.   "
165920|NCT00005736|"     To design, develop, implement, and test the effectiveness of a three component health     services and health education intervention for primarily Hispanic inner-city elementary     school students at high risk for asthma morbidity and mortality.   "
165921|NCT00005737|"     To conduct a three-arm, randomized controlled trial of methods to improve adherence to     biweekly directly observed prophylaxis (DOPT) for tuberculosis in homeless adults in San     Francisco.   "
165922|NCT00005738|"     To test a public health model of screening, preventive isoniazid treatment, and adherence     counseling plus medical education of primary care clinicians to enhance their skills and     attention to TB control. Also, to test a behavioral adherence intervention for Latino     adolescents with latent disease and a medical education program designed to enhance primary     care (community clinic) practitioners' treatment of active and latent TB infection.   "
165923|NCT00005739|"     To compare alternative methods to ensure completion of treatment and preventive therapy for     tuberculosis (TB) in inner cities, and to identify the most cost-effective methods to     accomplish that. The basis for comparison included adherence rates and cost savings as     primary outcomes, and other parameters such as patient satisfaction, development of social     networks, and participation in support programs as secondary outcomes.      Two clinical trials were conducted with patients from Harlem. Among those with active     disease, a clinic-based surrogate family model was compared to traditional community-based     directly observed therapy (DOT). Among those eligible for preventive therapy, a     community-based intervention conducted by trained graduates of a TB DOT program (peer     workers) was compared to traditional self-administered preventive treatment.   "
165924|NCT00005740|"     To develop a behavioral intervention aimed at public health workers who perform tuberculosis     contact investigation and designed to enhance the contact investigation process.   "
165925|NCT00005741|"     The Community Outreach Intervention Project (COIP) implemented and evaluated a TB     intervention with injection drug users (IDUs) in two Chicago Neighborhoods, guided by the     indigenous outreach leadership model that had been used for AIDS prevention among drug users.   "
165926|NCT00005742|"     To develop and test various educational strategies targeting primarily minority TB-infected     adolescents at two health centers in Los Angeles in an experimental design to assess the     relative effectiveness on medication adherence, appointment keeping, and completion of     therapy.   "
165927|NCT00005743|"     To develop intervention strategies that improve long-term exercise adherence in obese adults     in in order to improve long-term weight loss.   "
165928|NCT00005744|"     To conduct a randomized demonstration and education trial of churches in East Baltimore     testing a self-help, minimal intervention compared with an intensive physical activity     intervention.   "
165929|NCT00005745|"     To quantify the association between multiple intentional weight losses (i.e., weight     fluctuations) and the development of hypertension and diabetes mellitus among 50,790 female     nurses participating in the ongoing Nurses' Health Study II. In addition to assessing the     consequences of weight fluctuations, their correlates and course were identified.   "
165930|NCT00005746|"     To test the effectiveness of a community site neighborhood health worker/nurse (NHW/N) case     management strategy for coronary heart disease risk reduction compared with usual care in     apparently healthy African American siblings of persons with documented premature coronary     heart disease.   "
165931|NCT00005748|"     To examine the role of Transcendental Meditation in stress reduction and prevention of     hypertension in Blacks.   "
165932|NCT00005749|"     To determine the differential effectiveness of a culturally tailored program to shape and     maintain moderate intensity physical activity and to improve cardiorespiratory fitness among     low SES sedentary Latino women.   "
165933|NCT00005750|"     To conduct an integrated, multiple-component, school- and community-based intervention     targeting both primary and secondary prevention of obesity among third-fourth-and     fifth-graders (School- and Family-Based Obesity Prevention for Children).   "
165938|NCT00005755|"     To examine the occupations, industries and exposures in the work-place which were associated     with a high risk for asthma and other adverse respiratory health effects, with particular     emphasis on specific exposures of predominantly female occupations (irritants, detergents and     other asthmagens), and of other high risk major occupations which had not been adequately     examined.   "
165939|NCT00005756|"     To investigate the prevalence and prognostic value of subclinical atherosclerosis in the     Pittsburgh SHEP cohort and a cohort of normal controls.   "
165940|NCT00006415|"     The purpose of this study is to find out if anti-HIV drugs, taken by patients who are newly     infected with HIV, can make the level of HIV in the body too low to detect.      Studying patients who recently have been infected with HIV may help researchers understand     how HIV infection works and how anti-HIV drugs may help these patients. Approved anti-HIV     drugs can reduce the amount of HIV, but more research needs to be done in newly infected     patients. This study will look at recently HIV-infected patients to study the progression of     HIV disease and to see whether anti-HIV drugs can reduce the level of HIV.   "
165941|NCT00006417|"     This study will investigate the safety and effectiveness of a new stem cell transplant     procedure for treating chronic granulomatous disease (CGD) in patients with active infection.     CGD is an inherited disorder of neutrophils-a type of infection-fighting white blood     cell-that leaves patients vulnerable to life-threatening infections. Standard treatment with     antibiotics, and sometimes surgery, is not always successful, and patients with persisting     infections have a poor long-term prognosis.      Transplantation of donated stem cells (cells produced by the bone marrow that mature into the     different blood components-white cells, red cells and platelets) can cure CGD. However, this     procedure carries a significant risk of death, particularly in patients with active     infection, because it requires completely suppressing the immune system with high-dose     chemotherapy and radiation. In addition, lymphocytes-another type of infection-fighting white     blood cell-from the donor may cause what is called graft vs. host disease (GvHD), in which     the donor cells see patient's cells as foreign and mount an immune response to reject     them. To try to reduce these risks, patients in this study will be given low-dose     chemotherapy and no radiation, a regimen that is easier for the body to tolerate and involves     a shorter period of complete immune suppression. Also, the donor's lymphocytes will be     removed from the rest of the stem cells to be transplanted, reducing the risk of GvHD.      Patients with CGD between the ages of age 1 and 55 years old who have an active non-viral     infection may be eligible for this study. They will have a medical history, physical     examination and blood tests (including testing for adequacy of the genetic match with the     donor). A bone marrow sample will be taken to evaluate disease status. This test, done under     a local anesthetic, uses a special needle to draw out bone marrow from the hipbone. A central     venous catheter (flexible plastic tube placed in a vein) will be put in place before     treatment begins. It will be used to draw and transfuse blood, give medications, and infuse     the donated stem cells.      Several days before the transplant procedure, patients will start low-dose chemotherapy with     cyclophosphamide and fludarabine, two commonly used anti-cancer drugs. They will also be     given anti-thymocyte globulin to prevent rejection of the donated cells. When this     conditioning therapy is completed, the stem cells will be infused through the central line.     Patients will be given cyclosporine 4 days before and 3 months after the stem cell transplant     to help prevent rejection.      About 3 weeks after the transplant, patients will be discharged from the hospital. They will     return for follow-up clinic visits weekly and then twice weekly for 3 months. These visits     will include a symptom check, physical examination, and blood tests. Blood transfusions will     be given if needed. Subsequent visits will be scheduled at 4, 6, 12, 18, 24, 30 and 36 months     after the transplant, or more often if required, and then yearly.   "
165942|NCT00006418|"     This study will create a DNA collection with blood samples from families with at least two     siblings who have schizophrenia symptoms. This collection will help scientists identify genes     that predispose people to schizophrenia.   "
165943|NCT00006419|"     To examine the relationship of specific dietary factors to risk of chronic obstructive     pulmonary disease.   "
165944|NCT00006420|"     To continue surveillance of coronary heart disease (CHD) mortality and morbidity in the seven     county metropolitan Minneapolis/St. Paul (Twin Cities) areas.   "
165945|NCT00006421|"     This study will explore new screening methods for early detection of breast and ovarian     cancer in women at high risk for these diseases, because they have an altered breast cancer 1     (BRCA1) or breast cancer 2 (BRCA2) gene. It will also try to determine if breast tissue     characteristics in women with a BRCA1 or BRCA2 mutation differ from those in women with a     normal gene.      Premenopausal women between 25 and 45 years of age who have participated in National Cancer     Institute studies for families or individuals at high genetic risk of cancer (78-C-0039 or     99-C-0081) and who have at least a 50 percent probability of carrying an altered BRCA1 or     BRCA2 gene may be eligible for this study.      At the first visit, participants will have from 4 to 24 tablespoons of blood drawn and will     be interviewed about breast and ovarian cancer risk factors, family and personal history of     cancer, history of pregnancies, use of oral contraceptives and other hormones and drugs, and     previous surgery on the breasts and ovaries. In addition, they will undergo the following     procedures:      Routine breast and ovarian cancer screening for high-risk women, including a mammogram,     breast and pelvic exam, instruction in breast self-examination, CA 125 blood test and     transvaginal ultrasound of the ovaries.      Magnetic Resonance Imaging (MRI) of the breast MRI uses a strong magnetic field to show     structural and chemical changes in tissues.      Breast Duct Lavage In this procedure samples of fluid and cells from the lining of the breast     milk ducts are collected to look for cancerous or pre-cancerous cell changes.      Positron Emission Tomography (PET) scan PET scanning will be done only in participants whose     mammogram or MRI findings require additional evaluation. This diagnostic test is based on     differences in how cells take up and use glucose (sugar), one of the body s main fuels.      Annual follow-up visits will be scheduled for 3 years and will include routine high-risk     screening as described above, blood draw, update of family history and risk factors, breast     MRI, breast duct lavage and, if there are changes on the MRI or mammogram that need further     evaluation, the PET will be repeated.   "
165946|NCT00006422|"     This study offers evaluation and treatment for patients with pediatric eye diseases,     particularly amblyopia and strabismus. The protocol is not designed to test new treatments;     rather, patients will receive current standard of care treatments. The purpose of the study     is twofold: 1) to allow National Eye Institute physicians to increase their knowledge of     inflammatory eye conditions and identify possible new avenues of research in this area; and     2) to establish a pool of patients who may be eligible for new studies as they are developed.     (Participants in this protocol will not be required to join a new study; the decision will be     voluntary.)      Patients age 6 months and older with pediatric eye diseases, including amblyopia, strabismus,     cataracts, glaucoma, and developmental abnormalities may be eligible for this study.     Candidates will be screened with a medical history, eye examination, and diagnostic     procedures that may include routine laboratory testing, X-rays, questionnaires, physical     examination, and other standard or specialized tests or procedures as needed. The eye     examination includes measurements of eye pressure and visual acuity (ability to see the     vision chart), examination of the pupils and eye movements, and dilation of the pupils to     examine the lens and retina. In addition, patients will undergo a procedure to record eye     movements called oculography, in which special detectors measure infrared light reflected off     the patient's eyes while he or she watches lights on a computer screen.      Participants will be followed for at least 3 years. Visits will be scheduled from 1 to 6     times a year, according to the standard of care for the individual patient's eye problem.     Vision will be checked at each visit, and some of the screening tests described above may be     repeated to follow the progress of disease and evaluate the response to treatment.   "
165947|NCT00006424|"     This study will use magnetic resonance imaging (MRI) scans to explore how the brain changes     (reorganizes itself) in response to learning and to brain lesions in healthy people and     people with various physical disabilities.      Normal volunteers and patients with disabilities including blindness, limb amputation,     hemispherectomy (removal of a cerebral hemisphere), and stroke may be eligible for this     study. Candidates will be screened with medical and neurological examinations.      Participants will have MRI scans while they lie still or perform certain movements, as     instructed. MRI uses a strong magnetic field and radio waves instead of X-rays to show     structural and chemical changes in tissues. During the scan, the subject lies on a table in a     narrow cylinder containing a magnetic field. He or she can speak with a staff member through     an intercom system at all times during the procedure. All participants will first have a scan     to show brain structure, which will take about 30 minutes. A second scan will measure blood     flow or biochemical concentration and will take from 1 to 2 1/2 hours.      Depending on their disability, patients will participate in one of the following tests:        -  Blindness-This will study the ability of blind people to process tactile information.        -  Stroke- This will study mechanisms underlying recovery of motor function after stroke.          The patient will perform voluntary movements or remain still during the scan.        -  Amputation- This will study mechanisms underlying the ability of the brain to reorganize          after amputation. The patient will move different parts of the body or remain still          during the scan.        -  Hemispherectomy- This will study mechanisms underlying the ability of one side of the          brain to control movements of both arms. The patient will make different kinds of          movements during the scan.      Normal volunteers will participate in one of the following tests:        -  Use-dependent plasticity- This will evaluate the effectiveness of amphetamine and          placebo in demonstrating brain flexibility. The volunteer will take an amphetamine or          placebo (inactive pill) before the scan and then perform a specific exercise using the          thumb.        -  Motor fatigue- This will study the mechanisms that underlie fatigue, which affect many          patients with neurological conditions. The volunteer will contract muscles in the          forearm and hand for several minutes until he or she feels fatigue.        -  Light deprivation- This will evaluate changes in the brain that occur after light          deprivation. The volunteer will remain at rest in the scanner for up to 150 minutes.        -  Somatosensory stimulation-This will examine whether stimulation of the wrist can cause          changes in hand representation in the part of the brain that controls movement. The          volunteer will make hand movements at different times during the test. In addition, mild          electric shocks will be delivered to the wrist for up to 2 hours. Although the shock          intensity is regulated to avoid pain, there may be some discomfort.   "
165975|NCT00006484|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is more effective for non-small cell lung     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus     paclitaxel with or without tirapazamine in treating patients who have stage IIIB or stage IV     non-small cell lung cancer.   "
165976|NCT00006485|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with irinotecan     in treating patients who have locally advanced or metastatic solid tumors.   "
165978|NCT00006487|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation     therapy in treating patients who have limited-stage small cell lung cancer.   "
174449|NCT00117611|"     The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair     (omalizumab), will improve objective and subjective evidence of chronic sinusitis.   "
165948|NCT00006425|"     Women who carrying a BRCA1 or BRCA2 gene mutation or who are the first- or second-degree     relative of an individual with a BRCA-associated cancer in a family documented to have a     BRCA1 or BRCA2 mutation will be eligible for enrollment into this pilot study of breast     cancer screening modalities. We will recruit up to fifty women (twenty-five women who carry     an altered BRCA1 or BRCA2 gene and 25 non-carriers matched by age and family mutation type)     with regular menstrual cycling (documented by menstrual history and premenopausal FSH level).     A physical exam including exam of the breast and pelvis, a standard four view mammogram,     breast MRI and PET scan will be scheduled initially during either the follicular or     mid-luteal phase of the menstrual cycle. A unilateral cranio-caudal mammogram, and bilateral     MRI and PET scan will be repeated three months after entry during the phase not initially     studied. A CA125 and transvaginal color doppler ultrasonography will be done in the     follicular phase. Carriers and non-carriers will be compared with respect to menstrual cycle     differences in: (1) two measures of mammographic density (qualitative and semiquantitative);     (2) a semiquantitative measure of fibroglandular volume (MRI); (3) a semiquantitative measure     of contrast enhancement (MRI); and (4) FDG uptake measured over time (PET scan). On the     initial and three-month visit, all participants will undergo breast duct lavage to     investigate if there are consistent menstrual cycle differences in breast ductal cytologies.     Participants will be seen annually thereafter for an additional three years of follow-up. A     physical exam, standard four-view mammography, breast MRI, CA 125, transvaginal color doppler     ultrasonography and breast duct lavage will be done annually. Consent for a PET study will be     requested if an abnormality is detected on mammography or breast MRI requiring additional     clinical or radiographic follow-up.      Participants in the Menstrual Cycle Pilot Study, will complete a self-administered     questionnaire and telephone interview and will complete periodic follow-up questionnaires to     assess various behavioral and psychosocial endpoints.      As part of the Menstrual Cycle Pilot Study, we will recruit 25 volunteers to assist in     training study investigators in performing breast duct lavage. Cytologies obtained from     volunteers will be used to develop oncogene probe panels to be used in the study.   "
165949|NCT00006426|"     People with diabetes often develop severe skin problems (ulcers) on their feet. Sometimes     these are treated with surgery and other times by temporarily immobilizing the foot in a     cast. This study compares the effect of surgery to lengthen the Achilles tendon and put the     foot in a cast, to using a cast alone. The study will also examine how foot strength, joint     movement, and overall ability to walk, balance and climb stairs is affected.   "
165950|NCT00006427|"     This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults     that have had an amputation   "
165951|NCT00006428|"     This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic     pain in adults that have had a spinal cord injury.   "
165952|NCT00006429|"     This is a trial to test whether treadmill training can be used to improve the walking of     patients with partial spinal cord injury. While on the treadmill, patients will be partially     supported through the use of a specially designed harness attached to an overhead lift (also     called Body Weight Supported Treadmill Training, BWSTT). Patients who enroll in this study     will be randomly assigned to either the experimental group, which receives 12 weeks of this     specialized treadmill training with regular physical therapy, or to the control group, which     receives 12 weeks regular physical therapy. The ability of the patients to walk will be     measured before and after treatment as well as 6 and 12 months later, using standard tests     that examine mobility independence and speed of ambulation. The trial takes place across five     sites in the US and Canada. Patients eligible for this trial will have had a traumatic spinal     cord injury within 8 weeks of trial entry.   "
165953|NCT00006430|"     Purpose: This protocol proposes a safety and feasibility trial in patients with metastatic     prostate cancer (stages D1-D3) investigating the induction of antitumor immunity by     administration of cultured autologous peripheral blood precursor derived dendritic cells     (DC), transfected with mRNA amplified from autologous prostate tumor tissue. The feasibility     and dose-limiting toxicity of administering escalating doses of tumor RNA transfected     dendritic cells will be defined. As a secondary endpoint, the ability of tumor RNA     transfected dendritic cells to induce tumor-specific immune responses will be evaluated.     Finally, the anti-tumor effect based on PSA (biochemical) response criteria will be defined.      Background: Because prostate cancer is incurable when metastatic and conventional therapies     do not offer a clear survival benefit, new therapeutic strategies are warranted. This study     is based on the premise that clinically effective cell mediated immune responses against     prostate tumors can be elicited by activation of tumor associated antigen specific T cells.     Work performed by others and our group suggests that PSA, a protein expressed in virtually     all prostate cancers, can serve as a widely expressed candidate antigen for prostate cancer     immunotherapy. In particular, we have shown that cultured dendritic cells transfected with     mRNA encoding PSA are remarkably effective in stimulating antigen specific immunity in vitro.     Therefore, we hypothesize that administration of PSA RNA transfected DC will lead to     detectable levels of PSA specific CTL in the peripheral blood of patients with PSA expressing     metastatic prostate cancer. It is hoped that these T cell responses also have clinical     antitumor activity.   "
165954|NCT00006431|"     The feasibility and dose-limiting toxicity of administering escalating doses of dendritic     cells transfected with autologous renal cell carcinoma RNA DC(DCRCC-RNA) will be defined. As     a secondary endpoint, the ability of DCRCC-RNA to induce tumor-specific immune responses will     be evaluated. Finally, the anti-tumor effects measured by clinical response criteria, their     duration and overall survival (calculated at 2-year follow-up) will be determined in each     patient receiving dendritic cell therapy.      Background: Prognosis in metastatic renal cell carcinoma is poor with a median survival of     less than one year. Although renal cell carcinoma has shown some response to immunotherapy,     the results of systemic administration of biologic response modifiers in disseminated renal     cell carcinoma have been poor. Growing evidence suggests that active immunotherapy,     particularly dendritic cells (DC) based vaccines, may prove to be a viable and clinically     effective therapeutic option for patients with advanced or metastatic renal cell carcinoma.   "
165960|NCT00006437|"     This study will compare blood from healthy volunteers and with wound fluid and tissue samples     from patients with acute and chronic wounds enrolled in other NIH studies. Chronic wounds,     such as venous leg ulcers, pressure sores, ischemic ulcers and diabetic foot ulcers, affect     more than 4 million Americans each year and cost about $9 billion to treat. The nature of     these wounds is not well understood and treatments are not always successful, for unknown     reasons. Blood collected from healthy volunteers will be used to prepare a model for studying     various processes involved in wound healing.      Normal healthy volunteers 21 years of age and older who do not smoke and have no medical     problems of the heart, bones, muscles, stomach, lungs, blood, or nervous system, do not have     problems going to the bathroom, and have no infections may be eligible for this study.      Participants will be interviewed briefly for information on their date of birth, gender,     ethnic identity and medical history and will have a brief physical examination, including a     check of height and weight, vital signs and heart and lung sounds. About 14 milliliters (2     tablespoons) of blood will be drawn from the arm.   "
165955|NCT00006432|"     There is some consensus that high fat diets can contribute to the development of obesity and     type 2 diabetes in humans and animals. An increase in dietary fat has been shown to produce     obesity and diabetes in mice; such diet-induced diabetes can be reversed by reducing the fat     in the diet. In humans, there is some evidence that low-fat diets can produce acute     improvements in blood sugar control in type 2 diabetes-even in the absence of weight loss. In     most human studies, however, dietary fat reduction has been accompanied by a reduction in     total calorie intake. It is thus not possible to separate the effects of these 2 metabolic     changes. The purpose of this study is to gather preliminary information on the effect of a     very-low-fat diet on blood metabolism in persons with type 2 diabetes. The design     incorporates controlled feeding procedures, and 30 men and women with type 2 diabetes will be     given all foods for 4 weeks--a 2-week diet standardization period (diet composition: 35% fat,     15% protein, 50% carbohydrate), followed by a 2-week experimental diet period. The     experimental diet conditions are A) continuation of the moderately-high-fat standardization     diet, or B) a very-low-fat diet composed of 10% fat, 15% protein, 75% carbohydrate. Outcomes     will be measured after the standardization and the experimental periods. The primary outcome     variable is fasting plasma glucose; secondary outcomes are fasting insulin, carbohydrate     (meal) tolerance, insulin secretion and blood lipids. In addition, we will gather descriptive     data on the potential acceptability and utility of a very-low-fat diet constructed using the     fat substitute, olestra (sucrose polyester). There are no results yet.   "
165956|NCT00006433|"     Purpose: The purpose of this protocol is to evaluate the combination of Doxil chemotherapy     and heat treatment for recurrent breast cancer located on the chestwall following mastectomy.     This protocol also includes patients with metastatic breast cancer who have not had     mastectomy but have advanced tumor remaining within the breast. Doxil is the drug adriamycin     (also called doxorubicin) encapsulated in liposomes, which coats the drug with a small amount     of lipid (fat). This chemotherapy is in a newer form which can be better delivered to the     tumor tissue without causing as much systemic toxicity. We are combining heat treatment with     this drug in an effort to further increase the delivery of drug to the tumor, which may give     an increased tumor response.      Methods: The patients will be treated with chemotherapy followed by heat treatment. This will     be given for 6 cycles approximately every 4 weeks. For the first cycle patients will need to     be hospitalized 3 days for measurement of blood levels of drug as well as some additional     radiology studies which will help us to determine whether the drug is preferentially     distributed within tumor.   "
165957|NCT00006434|"     When patients relapse after primary chemotherapy for Non-Hodgkin's lymphoma, they may be     eligible to receive high-dose chemotherapy with autologous stem cell support. Unfortunately     high-dose chemotherapy is curative in less than half the patients who receive it. This study     is being conducted to determine the safety, side effects, and the ability to respond to an     investigational vaccine that consists of tumor-pulsed dendritic cells given with an immune     stimulating drug called interleukin-2. The patient must have a lymphomatous node accessible     for excision to prepare the vaccine. Dendritic cells are immune cells that are obtained from     the blood, and are important in the body's immune response to foreign substances. This study     will examine the response of the immune system after three vaccinations (composed of     dendritic cells, which have been exposed to dead fragments of lymphoma cells) given beginning     three months after transplant. Vaccination may result in sensitizing the patient's dendritic     cells to his lymphoma cells, potentially resulting in an immune response against the     lymphoma. Twelve patients will be treated on study.   "
165958|NCT00006435|"     Background:      -Plexiform neurofibromas in patients with NF1 are a significant cause of morbidity but little     is known about the natural history of these lesions.      Objectives:        -  The purpose of this study is to monitor the natural history of plexiform neurofibromas          and to evaluate the usefulness of volumetric MRI tumor measurements in this disease.        -  Other goals of the study are to provide a body of normative data on the growth rate of          plexiform neurofibromas and to establish a tissue repository and pathology review center          to allow future studies of the pathogenesis of neurofibromas and clinical trials of          potential therapeutic agents.      Design      - This study is coordinated by Dr. Bruce Korf, and was initiated when he was at the Partners     Center for Human Genetics, Boston, MA.   "
165959|NCT00006436|"     Background:        -  HIV-infected patients have a weakened immune system, and chemotherapy, which is used to          treat lymphoma, probably causes further damage to the immune system.        -  Limiting the amount of immune damage due to chemotherapy might decrease the number of          infections and the risk of developing cancer in the future in HIV-infected patients with          non-Hodgkin's lymphoma.      Objectives:        -  To determine whether reducing the total amount of chemotherapy using a specific          combination of drugs called EPOCH-R (etoposide, doxorubicin, vincristine,          cyclophosphamide and rituximab) will rid the body of lymphoma quickly while decreasing          the risk of infections and future cancers.        -  To determine whether the lymphoma will remain undetectable for at least one year if          treatment is stopped one cycle after the patient enters remission.      Eligibility:      -Patients with non-Hodgkin's lymphoma and HIV infection 4 years of age and older who have not     been treated previously with rituximab or cytotoxic chemotherapy.      Design:        -  Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than          six cycles.        -  The lymphoma is evaluated using CT and PET scans at the end of treatment cycles 2 and 3.          A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on          screening for participation in the study.        -  Anti-HIV therapy is stopped before chemotherapy begins and is restarted when EPOCH-R          treatment ends.        -  Patients are monitored for treatment response with blood tests and imaging scans at          baseline, when treatment ends, 2 months after treatment ends and then every 3 to 6          months for a total of 24 months following chemotherapy.   "
165961|NCT00006438|"     The purpose of this study is to compare how 3 special types of shoes with rocker-shaped soles     help people with foot deformities to walk better. This study will use modern gait lab     techniques to measure the forces on the bottom of the feet and to examine whether there is     any effect higher on the leg from the rocker soles.   "
165977|NCT00006486|"     Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating     patients who have metastatic kidney cancer. Carboxyamidotriazole may stop the growth of     kidney cancer by stopping blood flow to the tumor   "
165962|NCT00006439|"     Adherence to complex medication regimens is critical to successful treatment of HIV     infection. Unfortunately, adherence to medical regimens with conventional interventions     averages 50% in chronic disease. We have observed that adherence barriers that were     unrecognized by providers in the clinic setting have been detected during home visits. It is     possible that recognition and interventions to resolve adherence barriers observed during     home visits may improve adherence. This proposal will test the hypothesis that home-visits     which identify previously unrecognized adherence barriers and provide support and education     will increase medication adherence among children and youth with HIV infection and improve     the patient/health care provider relationship. Specific aims of the study are: 1. Determine     the impact of a series of home-visits on adherence to medication regimens for HIV infected     youth and children. 1a. Adherence to medical regimens will be assessed before and after the     series of home-visits using a self-report questionnaire and Microelectronic Monitoring System     (MEMS) or in-home pill count. 1b. For each of these measures a percentage of adherence will     be calculated and compared from a baseline to after the final home visit and after the six     month follow up period. 2. Assess the changes in patient satisfaction from baseline to after     the home-visits using a questionnaire completed by the patient/family. 3. Incorporate a pilot     study to assess the changes in the provider's knowledge of the patient's family     characteristics and home circumstances relevant to adherence following the home visits.   "
165963|NCT00006440|"     The purpose of this study is to find out if it is possible to conduct a group counseling     program for women at risk for HIV infection.      Women have been the fastest-growing group with new AIDS diagnoses. The need for ways to     reduce HIV infection in women is urgent. It is important to reduce the risk of HIV infection     through sexual contact, but it is also important to address drug use. Group counseling may be     an effective method.   "
165964|NCT00006441|"     The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV     drugs affects the course of HIV disease in patients with primary HIV infection (the time     period that immediately follows infection with HIV).      After primary HIV infection, the actual infection is spread through an increasing amount of     HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it     is possible to reduce the amount of HIV in the body to almost undetectable levels. This study     will find out if starting anti-HIV drugs during primary infection will interrupt or reduce     the spread of HIV in patients' bodies.   "
165965|NCT00006442|"     The purpose of this study is to examine the HIV virus in the blood and lymphoid tissues of     patients taking anti-HIV medications.      HIV infection is closely linked to the growth of the HIV virus in the body. Much of this     information was obtained from studying how the HIV virus grows in circulating blood. Recent     studies have shown that the lymphoid tissue (part of the immune system) is a major site where     HIV is found in the body and is also where much of the HIV virus growth occurs. This study     will examine not only blood but also lymphoid tissue to gain a better understanding of the     disease and how to treat it.   "
165966|NCT00006475|"     RATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective     treatment for leukemia.      PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have     chronic myelogenous leukemia in blast crisis.   "
165967|NCT00006476|"     RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor.      PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have     recurrent bladder cancer.   "
165968|NCT00006477|"     RATIONALE: Mistletoe lectin may slow the growth of cancer cells and be an effective treatment     for solid tumors.      PURPOSE: Phase I trial to study the effectiveness of mistletoe lectin in treating patients     who have refractory advanced solid tumors.   "
165969|NCT00006478|"     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune     response to kill cancer cells. Vaccine therapy may be an effective treatment for     non-Hodgkin's lymphoma.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy     and peripheral stem cell transplantation in treating patients who have non-Hodgkin's     lymphoma.   "
165970|NCT00006479|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and combining chemotherapy with     surgery may kill more tumor cells. It is not yet known if surgery is more effective with or     without chemotherapy for liver metastases.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without     combination chemotherapy in treating patients who have liver metastases from colorectal     cancer.   "
165971|NCT00006480|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cell from growing. Inserting genetic material made in the laboratory into a person's     blood cells may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of biological therapy and gene therapy in     treating children who have recurrent or refractory neuroblastoma.   "
165972|NCT00006481|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, but may cause     skin irritation and inflammation. Biafine cream may be effective in lessening side effects     caused by radiation therapy.      PURPOSE: Randomized phase III trial to determine the effectiveness of Biafine cream in     reducing side effects of radiation therapy in patients receiving treatment for head and neck     cancer.   "
165973|NCT00006482|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and cisplatin in     treating patients who have refractory or recurrent cancer of the cervix.   "
165974|NCT00006483|"     RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune     cells found in bone marrow or peripheral blood and may be an effective treatment for patients     with kidney cancer that has spread to the lung.      PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who     have kidney cancer that has spread to the lung.   "
166004|NCT00006515|"     This study will examine late effects of treatment for sarcoma (bone and soft tissue cancers)     in children. Survival of patients with these diseases has improved over the years, but     long-term adverse effects of treatment have also been noted.      Patients previously treated for sarcoma in the NCI's Pediatric Oncology Branch who are in     their first remission from sarcoma after completion of therapy and who have had no further     cancer treatment (chemotherapy, radiation therapy, cancer related surgery or immunotherapy)     for at least 24 months may be eligible for this 3- to 4-day study. It will review the     incidence and extent of the following late effects of therapy.        -  Heart problems-The chemotherapy drug doxorubicin can cause acute and late injuries to          the heart muscle. Patients will undergo magnetic resonance imaging (MRI) of the heart to          look for changes and compare the findings with information obtained by standard          echocardiogram (ultrasound test of the heart) and by MUGA (nuclear medicine scan of the          heart).        -  Gonadal dysfunction-The chemotherapy drug cyclophosphamide may affect sex hormone          production, leading to infertility, early menopause or brittle bones. Low sex hormone          levels may also increase the risk for heart attack, obesity or fracture. Patients will          have blood tests to measure hormone levels as well as mineral levels, lipid levels and          blood cell counts. They will also have a DEXA scan to measure bone mineral density and a          CT scan of the abdomen to evaluate the distribution of fatty tissue in the abdomen.          Males will be offered a semen analysis as part of the fertility evaluation.        -  Psychosocial problems- Cancer diagnosis and treatment pose a major life stress that can          lead to problems with personal relationships, jobs, insurance, education, health care,          and personal and professional goal setting. Some patients may become depressed or          develop a psychiatric illness. Patients will fill out a questionnaire about their          treatment, recovery, and aspects of their current life and will meet with a psychologist          and psychiatrist.        -  Changes in bodily function and capabilities-Patients who undergo surgery and radiation          to treat sarcoma treatment may experience muscle, bone and joint changes. Patients will          be interviewed about their performance of daily activities, physical limitations, and          changes in skill levels. They will do a series of exercises and will have measurements          of strength, mobility and physical skills, focusing on the parts of the body that were          affected by the sarcoma and subsequent local therapy.        -  Exposure to viruses-A number of patients received blood transfusions as part of their          cancer treatment. Some transfusions were given before HIV screening became available.          Patients will be tested for this virus as well as the hepatitis virus and HTLV-1 (human          T-cell leukemia virus-1), for which there are also small transfusion-associated risks.        -  Kidney function-The chemotherapy drug ifosfamide may affect kidney function. Patients          will provide a urine specimen for kidney function tests.        -  Immune function-Chemotherapy affects the function of infection-fighting immune cells          called T-lymphocytes. A blood sample will be drawn for studies of the time involved in          recovering full immune function.   "
166005|NCT00006516|"     This study examines the potential benefits of a home stimulation program to treat infants who     have suffered from brain asphyxiation (lack of oxygen). The program involves one year of     stimulatory activities. Progress will be evaluated through neurological and behavioral exams.   "
165979|NCT00006488|"     Parkinson's disease is characterized by loss of neurons that produce dopamine in a region of     the brain called the substantia nigra. In the early stages of the disease, the disease     responds to agents that replace dopamine such as levodopa. Patients with more advanced     disease have wide fluctuations in their response to levodopa, exhibiting on and off periods.     This is due to continued degeneration of neurons. Recombinant-methionyl human glial cell     line-derived neurotrophic factor (r-metHuGDNF or GDNF) is a neurotrophic factor that promotes     survival of dopaminergic neurons. This is a protein produced by recombinant technology that     is almost identical to the naturally produced factor. Results of animal studies indicate that     GDNF has the potential to benefit patients with advanced Parkinson's disease.      The purpose of this clinical trial is to determine whether GDNF works to relieve symptoms of     advanced Parkinson's disease. The study will also test the delivery of GDNF using a catheter     implanted into the putamen, the area of the brain associated with Parkinson's disease, and an     infusion pump that is implanted under the skin in the abdomen or chest. GDNF will be placed     into the pump and delivered through the catheter to the brain. The purposes of this study are     to determine the potential benefits and side effects of GDNF. The performance and safety of     the catheter/infusion pump system will also be assessed. The study will last for 6 months.     Subjects will undergo neurological testing, computerized gait assessment and neurological     imaging.   "
165980|NCT00006489|"     This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol     dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a     6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial     therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced     medication management intervention will accompany all treatment conditions. Follow-up     assessments will be completed at 9 and 12 months after treatment.   "
165981|NCT00006490|"     The purpose of this study is to compare 2 different types of tests of the HIV virus to see     which specific anti-HIV drugs would work the best.      Drug resistance is a major reason for therapy failure in HIV patients. Two types of tests can     detect resistance to drugs: 1) genotyping (sequencing), which looks at the DNA sequence of a     virus to see whether it has developed any genetic resistance; 2) phenotyping, which looks at     the ability of different drugs to suppress virus growth in the laboratory. Genotyping and     phenotyping can help doctors give patients the most effective drug therapy.   "
165982|NCT00006492|"     This study will screen patients with cerebellar ataxia to check for antibodies that indicate     allergy to gluten (wheat protein) and will study the effect of a gluten-free diet in patients     with these antibodies. Patients with cerebellar ataxia have problems with coordination,     resulting in clumsiness and unsteadiness of posture and walking.      There are many known causes of cerebellar ataxia, but in many patients the cause is unknown     and there are no available treatments. Cerebellar ataxia has been recognized as a     complication of celiac disease, a syndrome characterized by sensitivity to gluten.     Recognizing gluten sensitivity in patients with cerebellar ataxia would be important for two     reasons: it would be one of the rare causes of the disease that are potentially treatable,     and it would identify patients at risk for developing gastrointestinal cancers, particularly     intestinal lymphoma.      Patients with cerebellar ataxia of known or unknown cause and normal healthy volunteers of     any age are eligible for this study.      All participants will have a medical history, physical examination, blood drawn (30     milliliters, or 2 tablespoons) to check for celiac disease antibodies, and possibly other lab     tests. This completes the participation of normal volunteers.      All patients will have magnetic resonance imaging (MRI) of the brain. This diagnostic tool     uses a strong magnetic field and radio waves instead of X-rays to show structural and     chemical changes in tissues. During the scanning, the patient lies on a table in a narrow     cylinder containing a magnetic field. He or she can speak with a staff member via an intercom     system at all times during the procedure. Scanning times vary from 20 minutes to 2 hours.      Patients who have celiac disease antibodies will have an upper gastrointestinal (GI)     endoscopy intestinal biopsy. For this procedure, a flexible tube is inserted into the mouth     and down the throat into the stomach and duodenum (the upper part of the small intestine),     where a small tissue sample is taken for microscopic examination. Patients with these     antibodies will be put on a gluten-free diet and will be followed at NIH every 3 months for     12 months. On the first visit, patients will have their ataxia evaluated using NINDS's ataxia     scale and will meet with a dietitian for instructions for a gluten-free diet. On the second     through fifth visits (after 3, 6, 9 and 12 months, respectively, on the gluten-free diet),     patients will have their ataxia evaluated, speak with a dietitian to assess their nutritional     status, weight, and compliance with the diet, and provide a blood sample for celiac disease     antibody testing.      At the completion of the study, patients may choose to continue or stop the gluten-free diet.     If the ataxia assessments show improvement, patients will be advised to continue the     gluten-free diet permanently.   "
165983|NCT00006493|"     The purpose of this research is to study the effects of rosiglitazone, a drug usually taken     for Type II diabetes, on HIV-associated hyperlipidemia. HIV-associated lipodystrophy is a     medical condition characterized by gradual changes in the distribution of body fat. The body     fat located in the extremities and face disappears while body fat around the abdomen and     upper back increases. Certain biochemical changes occur in association with these changes in     fat distribution. Lipid levels particularly serum triglycerides are increased. HDL, the good     cholesterol is decreased. Higher than normal level of insulin or insulin resistance is also     found in this condition. This latter condition is one of the hallmarks of Type II diabetes.     The protease inhibitors, a class of HIV medications, are associated with the occurrence of     HIV-associated lipodystrophy. It has been suggested that a biochemical pathway known as the     peripheral peroxisomal activating receptor (PPAR) gamma system is blocked leading to the     onset of this condition.      Rosiglitazone is a new drug approved by the FDA in 1999 for the treatment of type II     diabetes. It lowers blood sugar by improving insulin resistance, which as mentioned before,     is the hallmark of Type II diabetes. It has also been noted to improve blood lipid levels.     Rosiglitazone works by stimulating the PPAR gamma system. It is hoped that this drug can turn     on the PPAR system and reverse the HIV-associated lipodystrophy syndrome.   "
166006|NCT00006517|"     We are offering non-pharmacologic therapy for alleviation of symptoms associated with     depressed mood that recurs annually in fall or winter. The treatments are self-administered     at home by the patient, with close clinical supervision. Our trials use specially designed     devices that replenish two different environmental elements, naturally occurring light and     negative ions in the air. Both factors may be reduced in winter, bringing on depression.   "
166032|NCT00006825|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing.     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy     with monoclonal antibody therapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab     in treating women who have advanced breast cancer.   "
166034|NCT00006877|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who     have metastatic non-small cell lung cancer.   "
165984|NCT00006494|"     The purpose of this study is to determine how laboratory tests called genotyping and     phenotyping assess the effectiveness of antiretroviral drugs used to treat HIV infection.     Some HIV-infected patients have measurable levels of virus in their blood even though they     are taking combination drug therapy-including didanosine, stavudine, or efavirenz-against     HIV. Genotyping and phenotyping can be used to test for resistance to a specific drug,     thereby providing information that can help doctors decide on optimal drug treatment for a     given patient. Genotyping identifies mutations, or changes, the virus undergoes that allow it     to continue to grow despite drug treatment. Phenotyping involves growing the virus in test     tubes with different amounts of drug and then calculating how much drug is required to stop     its growth.      Patients 18 years of age and older with HIV infection and viral levels between 5000 and     100,000 copies per milliliter of blood who have been taking antiretroviral therapy for at     least 6 months may be eligible for this study. Candidates will be screened with a urine test     and various blood tests, including genotyping and phenotyping.      Participants will have a series of tests to determine whether or not a drug is active against     HIV. This involves temporarily stopping the drug under study (i.e., either efavirenz or     didanosine or stavudine). The study procedure is as follows:        1. Patients will have six blood tests over 10 days to measure viral load while on all          current anti-HIV medications. On one of those days two blood tests will be done to          measure levels of didanosine or stavudine. Efavirenz will also be measured if this drug          is to be stopped.        2. The patient will temporarily stop the drug under while continuing to take the other          drugs. (Efavirenz will be stopped for 3 weeks; stavudine and didanosine will be stopped          for 2 weeks.) Seven blood tests will be done at the following intervals to measure viral          load: For patients who stop efavirenz, blood will be drawn on days 13, 18, 20, 22, 24,28          and 30. (Day 0 is the first day of the study.) Patients who stop stavudine or didanosine          will have blood drawn on days 11, 13, 15, 17, 19, 22 and 24. Repeat genotype and          phenotype testing will also be done during this time, and a CD4 count (measurement of a          certain type of white blood cell) will be done at the end of this 2- or 3-week period.        3. The drug that was stopped will be restarted and viral load tests will be repeated. For          pati...   "
165985|NCT00006495|"     The purpose of this study is to see how the vaccines Remune (HIV-1 immunogen) and vCP1452     affect immune responses in patients who also are taking anti-HIV medications. This study also     will see if these vaccines are safe to use either alone or in combination.      Treatment with anti-HIV drugs does not always keep HIV viral load low and under control. This     study will look at the effect of the HIV vaccine, vCP1452, on the immune response and how it     works in combination with Remune. Information about immune responses and the safety of these     vaccines in HIV-positive patients will be gathered.   "
165986|NCT00006496|"     To examine the possible relationship between genetic factors and the acute respiratory     distress syndrome (ARDS).   "
165987|NCT00006497|"     To assess changes in coronary calcium measured by electron beam computed tomography (EBCT) as     a predictor of coronary heart disease (CHD) events.   "
165988|NCT00006498|"     To prospectively examine the association between a specific chronic life stressor (i.e.,     intimate violence exposure) and adult asthma in women.   "
165989|NCT00006499|"     To define the underlying genetics of hypertension in an Asian population by studying     intermediate phenotypes.   "
165990|NCT00006500|"     To examine trends in trans-fatty acid intake by using newly available nutrient data to     recalculate 24 dietary recalls from the Minnesota Heart Survey.   "
165991|NCT00006501|"     To evaluate whether T Wave Alternans can predict ventricular arrhythmias and sudden cardiac     death (SCD) in a prospective epidemiologic natural history study.      The prospective epidemiologic pilot study included 550 patients that had left ventricular     dysfunction and no history of sustained ventricular arrhythmias. The primary hypothesis     tested was whether there was an increased risk of having an arrhythmic event when T Wave     Alternans was present in the patient. The secondary aims included comparing risk due to T     Wave Alternans between the ischemic patients and non-ischemic patients and assessing whether     T Wave Alternans remained an independent predictor of risk upon adjustment for other known     risk factors for arrhythmic events such as ejection fraction, ventricular ectopy, NSVT,     average NN interval, and RR interval variability.      The study approach was a standard epidemiologic surveillance technique. The subject     population consisted of individuals with Class I to III heart failure who will underwent a     TWA and Holter monitor test and then were followed for up to two years or until arrhythmic     events occured.   "
165992|NCT00006502|"     To determine whether an impairment of myocardial perfusion reserve is an early indicator of     coronary artery disease.   "
165993|NCT00006503|"     To evaluate subclinical atherosclerotic disease in menopausal women.   "
165994|NCT00006504|"     To determine the association between flavonoids intake and the prevention of incident     cardiovascular disease (CVD).   "
165995|NCT00006505|"     This study will test whether a new islet transplant procedure will enable patients with type     1 diabetes mellitus to stop insulin therapy. Islets are cell clusters in the pancreas that     contain insulin-producing cells. The new procedure features three important advances, first     developed by a group in Edmonton, Canada, over the way islet transplants have traditionally     been performed: 1) the islets are transplanted immediately after they are removed from the     donor; 2) islets are transplanted from two different donors in order to obtain the number of     islets in a normal pancreas; and 3) the anti-rejection drug regimen is designed to reduce the     harmful side effects of conditioning chemotherapy. (In the standard transplant procedure,     patients receive intensive chemotherapy following the transplant. This study will use no     radiation and lower-dose chemotherapy.)      Patients between the ages of 18 and 65 with the diagnosis of type 1 diabetes mellitus for at     least 5 years may be eligible for this study. Candidates will be screened with a medical     history and physical examination, blood tests, chest X-ray and tuberculin skin test,     electrocardiogram and exercise test for heart function, abdominal ultrasound, psychological     evaluation, and an arginine stimulated c-peptide test. The latter test determines if the     patient is producing any insulin. Eligibility is restricted to patients who make no insulin     at all.      The study has an active phase lasting 15 months and follow-up that continues indefinitely.     Patients will receive 10,000 islet equivalents per kilogram (2.2 pounds) of body weight.     This will likely require two separate transplant procedures from two donors. Before the first     surgery, patients will be given anti-rejection (immune suppressing) drugs, including FK506     and rapamycin (orally) and daclizumab (intravenously). The islets will be infused through a     tube placed in the portal vein (the large vein that feeds the liver). After surgery, patients     will receive insulin intravenously for 24 hours. They will then have an abdominal ultrasound     and blood tests to determine liver function. If fewer than 10,000 islets were transplanted,     patients will continue insulin treatment, with the dosages adjusted to account for the     transplanted islets. They will take Daclizumab every 2 weeks, and FK506 and rapamycin daily.     Blood tests to follow how much of these drugs are in the blood stream will be performed daily     at first and then weekly after blood levels of these drugs stabilize. They will be given     antibiotics to prevent infections. The arginine test will be repeated 2 weeks after the     transplant and periodically thereafter. Blood will be drawn weekly to check drug levels, and     monthly for other tests. The investigators will track daily insulin requirements, and these     will be recorded monthly.      Patients who require a second transplant to achieve the required amount of islets will return     for the procedure when a compatible organ is donated. The second procedure will be done as     described above. As before, insulin will be infused for 24 hours following surgery. It will     then be stopped, however, and will not be resumed unless blood glucose levels reach above 180     milligrams/deciliter. Patients will continue taking FK506 and rapamycin indefinitely.     Daclizumab will be given every 2 weeks for 4 doses following the second transplant, and then     stopped. Patients will take an antiviral called ganciclovir for 14 weeks and another     antibiotic for 1 year following surgery. For the first year after surgery, patients will have     frequent blood tests to monitor drug levels and immune function. They will return to NIH for     a complete history and physical examination 2 and 3 years after the final islet transplant     and will be contacted yearly by phone to ascertain their general health status and whether     they remain insulin independent.   "
165996|NCT00006507|"     Children with Sensory Modulation Dysfunction (SMD) either over- or under-react to stimuli in     their environment. This can cause significant problems with daily activities and may lead to     anxiety, poor attention, low self-esteem, and further complications in motor, cognitive,     social and emotional development. Diagnosis of SMD is based on physiological responses to     specific stimuli, measures of behavioral/social/emotional symptoms, and studies of the     resulting functional limitation and disability. Treatments involve direct biomedical and     behavioral intervention to improve sensory processing, as well as adjustments to the home,     school and community environment. This study will compare the effect of occupational therapy     vs. alternative therapy on the reactivity and function of children who have SMD.   "
165997|NCT00006508|"     We wish to identify people with hypoglycemia (low blood sugar) and ultimately determine why     the blood sugar levels are so low. To do so, we will contrast the responses of patients     suspected to have hypoglycemia with those of healthy subjects during standardized tests.     Those tests may include: 1) a controlled hypoglycemia produced by administration of insulin,     a blood sugar-lowering hormone, and sugar, 2) a formula meal, and 3) a period of up to 72     hours without food.   "
165998|NCT00006509|"     The purpose of this study is to see if 2 study vaccines, ALVAC-HIV (vCP1452) and gp160     MN/LAI-2, are safe and effective in boosting the body's attacks on HIV in HIV-positive     patients.      HIV-infected patients who have been treated with anti-HIV drugs for a long time may have     weakened immune responses. One way to strengthen these responses may be to have a safe and     effective vaccine, which will boost immune responses that are specific to HIV.   "
165999|NCT00006510|"     To identify susceptibility genes associated with asthma and asthma related phenotypes.   "
166000|NCT00006511|"     To identify gene variants in human chromosome 5Q31-33 that may be involved in the     pathogenesis of asthma.   "
166001|NCT00006512|"     To identify the predisposing genes responsible for asthma and bronchial hyperresponsiveness     (BHR) at region 5p13.3 in an inbred Hutterite community.   "
166002|NCT00006513|"     To assess the population burden of occupational exposures in the prevalence and progression     of chronic obstructive pulmonary disease (COPD).   "
166003|NCT00006514|"     To statistically examine cardiovascular disease (CVD) risk in different populations based on     data from studies representing national samples, cohort studies, and clinical trials.   "
166007|NCT00006518|"     BACKGROUND: A number of important scientific advances can be made through the study of blood,     bone marrow, tumor, or other tissue samples from patients with HIV infection, infection with     Kaposi s sarcoma associated herpesvirus (KSHV), infection with other oncogenic viruses, or     cancer. This protocol provides a mechanism to effect a variety of such studies.      OBJECTIVES: Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue     samples from patients with HIV infection, KSHV infection, or with cancer.      ELIGIBILITY: Eligibility criteria include age 18 years or older and at lest one of the     following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV     seropositive; HTLV-1 seropositive; malignancy, Castleman s disease, or skin lesions with     appearance of Kaposi s sarcoma; or cervical or anal intraepithelial lesion.      DESIGN: Blood samples may be collected at the initial visit, and at follow-up visits. Tumor     samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid,     by skin punch biopsy, or by excisional biopsy, providing the tumor is accessible with minimal     risk to the patients. Specific risks will be described in a separate consent to be obtained     at the time of the biopsy. Samples will be studied in the HIV and AIDS Malignancy Branch,     CCR, NCI; laboratories in NCI-Frederick; or those of collaborating investigators.   "
166008|NCT00006519|"     This study will test the safety, side effects and anti-HIV activity of different doses of     capravirine in children and adolescents with HIV infection. Capravirine belongs to a class of     drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which prevent the     virus from replicating (making more copies of itself). Other NNRTIs are nevirapine,     delavirdine and efavirenz.      HIV-infected children between the ages of 4 months and 21 years may be eligible for this     study if they: 1) have received less than 6 weeks of treatment with antiretroviral drugs; 2)     have not benefited from antiretroviral therapy after 12 weeks of treatment; 3) cannot     continue antiretroviral treatment because of harmful side effects.      For the first week of the study, participants will have a 1-week washout period in which     they will receive no anti-HIV therapy. During this time, they will have physical, eye and     neuropsychologic examinations, blood and urine tests, echocardiogram, electrocardiogram     (EKG), chest X-ray, head CT scan and skin tests. These physical exams and tests will be     repeated throughout the study to determine changes in health.      After the washout period, patients will take capravirine once a day in the morning for 6     days. After each dose, a small amount of blood will be drawn at 8 different times over 12     hours to measure the activity of the drug and HIV blood levels. A heparin lock will be placed     in the vein to avoid multiple needlesticks. After the 6 days of capravirine there will be     another washout period, this time for 21 days. During this time, doctors will determine the     optimum combination therapy for the individual patient.      After the second washout, patients will begin combination therapy with capravirine plus at     least two other anti-HIV medicines. (These may include a reverse transcriptase inhibitor such     as zidovudine, didanosine, lamuvidine, zalcitabine, or stavudine, and maybe one or more     protease inhibitors such as ritonavir, nelfinavir, saquinavir, indinavir or amprenavir.) For     the first week, patients will have a daily blood test to determine HIV blood levels.     Afterwards, treatment will continue on an outpatient basis with clinic visits every 4 to 8     weeks for physical exams, lab tests and other procedures as required. The study will last     approximately 48 weeks. Patients who benefit from capravirine therapy may be able to continue     to receive the drug from the drug company sponsor or as part of another study, or the     protocol for this study may be amended to lengthen the treatment period.   "
166009|NCT00006526|"     To investigate use of Fast Gated Helical Computed Tomography (FGHCT) measures of coronary     artery calcium (CAC), FGHCT-CAC, for discrimination of coronary artery disease (CAD) and to     quantify progression of coronary artery calcium over time.   "
166010|NCT00006539|"     To evaluate a series of thrombotic, inflammatory, and genetic markers for myocardial     infarction among participants in the Women's Health Initiative Observational Study (WHI-OS).   "
166011|NCT00006552|"     To assess factors that may influence adherence to antihypertensive drug therapy.   "
166012|NCT00006565|"     The purpose of this study is to test the effects of reducing indoor environmental tobacco     smoke (ETS) on unscheduled asthma visits, asthma symptoms, airway inflammation, and exposure     to tobacco smoke measured using air nicotine dosimeters, serum and hair cotinine.   "
166013|NCT00006578|"     The purpose of this study is to see if the amount of stem cells (cells that can develop into     many kinds of cells) in the blood before anti-HIV drugs are taken can predict if the immune     system will become stronger after anti-HIV drugs are given and if anti-HIV drugs can restore     stem cells.      HIV infection has been shown to cause stem cells not to function well. Granulocyte     colony-stimulating factor (G-CSF), which causes stem cells to go from the bone marrow     (tissues in the bones where blood cells are formed) into the bloodstream, could possibly help     boost immunity after anti-HIV treatment. This study examines the effects of G-CSF in helping     the immune system become stronger after beginning anti-HIV treatment.   "
166014|NCT00006591|"     The purpose of this study is to determine if treatment with an anti-HIV drug containing     ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who     have failed an anti-HIV drug treatment containing nelfinavir.   "
166015|NCT00006604|"     The purpose of this study was to find a safe and tolerable dose of the protease inhibitor     (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken     with other anti-HIV drugs in HIV infected infants, children, and adolescents.      Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to     make, in part because these patients often do not take the drugs as prescribed. ATV may be a     better option because it is available in the form of powder which children and adolescents     may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV     may also increase the chances of virologic response of highly active antiretroviral treatment     (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with     or without low-dose RTV boost in infants, children, and adolescents. For this study,     participants were enrolled in the United States and South Africa.   "
166016|NCT00006617|"     The purpose of this study is to see if the multidrug combination of zidovudine (ZDV),     lamivudine (3TC), 1592U89 (abacavir [ABC]), and 141W94 (amprenavir [APV]) is a safe and     effective treatment for HIV-infected patients and if there is a reduction of active HIV in     blood and other tissues.      HIV infection is a life-changing illness and new HIV treatments must be tested. This study     will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues     and if it is safe and well tolerated. Doctors also want to know if the multidrug combination     is able to decrease viral activity over a long time period.   "
166017|NCT00006630|"     The purpose of this study is to follow responses to treatment with vaccinia immune globulin     (VIG) for safety and clinical benefit [during HIV vaccine research].      VIG is purified from human blood and used to treat serious infections of the vaccinia     (smallpox vaccine) virus or similar viruses. It is the only treatment available for those     viruses. The only available supply of VIG has developed a discoloration over time and     therefore is considered an investigational new drug by the FDA. This study will allow it to     be used for intramuscular injection in a controlled setting for people who may need it     [during HIV vaccine research].   "
166018|NCT00006643|"     The purpose of this study is to find if the Single Photon Emission Computed Tomography     (SPECT) scan is as effective as a liver biopsy (using a special needle to remove tissue from     the liver) in examining liver damage in patients with HIV and hepatitis C virus (HCV).      A standard way to examine the liver for disease has been to perform a liver biopsy. The SPECT     scan, which takes a picture of the liver, has been found to be effective in determining liver     damage but studies need to be done in patients with hepatitis. This study will compare the     effectiveness of the liver biopsy and SPECT scan in determining liver disease in patients     with HIV and HCV. The SPECT scan might be a good replacement for the liver biopsy if it is     found to be as good as or better than liver biopsies.   "
166019|NCT00006656|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who     have progressive or recurrent glioblastoma multiforme.   "
166020|NCT00006669|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to kill cancer cells. Combining monoclonal antibody therapy     with chemotherapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab followed by combination     chemotherapy in treating patients who have refractory or recurrent non-Hodgkin's lymphoma.   "
166021|NCT00006682|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vinorelbine combined with docetaxel in     treating women who have metastatic breast cancer.   "
166022|NCT00006695|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy     use different ways to stop cancer cells from dividing so they stop growing or die. Combining     chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses     of chemotherapy drugs and kill more cancer cells.      PURPOSE: This phase II trial is studying how well monoclonal antibody therapy, chemotherapy,     and peripheral stem cell transplant work in treating patients with relapsed or refractory     non-Hodgkin's lymphoma.   "
166023|NCT00006708|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells     and either kill them or deliver cancer-killing substances to them without harming normal     cells. It is not yet known whether combination chemotherapy is more effective with or without     rituximab for non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without rituximab in treating patients who have relapsed or refractory non-Hodgkin's     lymphoma.   "
166024|NCT00006721|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from     dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either     kill them or deliver radioactive tumor-killing substances to them without harming normal     cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is     more effective in treating non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given     together with combination chemotherapy to see how well they work in treating patients with     newly-diagnosed non-Hodgkin's lymphoma.   "
166025|NCT00006734|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     tumor cells. It is not yet known which chemotherapy regimen combined with radiation therapy     and/or surgery is more effective in treating Ewing's sarcoma or primitive neuroectodermal     tumor.      PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy     regimens combined with radiation therapy and/or surgery in treating patients who have Ewing's     sarcoma or primitive neuroectodermal tumor.   "
166026|NCT00006747|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.     Peripheral stem cell transplantation may be able to replace immune cells that were destroyed     by chemotherapy used to kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     donor peripheral stem cell transplantation in treating patients who have mantle cell     lymphoma.   "
166027|NCT00006760|"     RATIONALE: Drugs used in chemotherapy, such as ifosfamide and vinorelbine, work in different     ways to stop cancer cells from dividing so they stop growing or die. Combining more than one     drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     children who have refractory or relapsed Hodgkin's lymphoma.   "
166028|NCT00006773|"     Phase I trial to study the effectiveness of bortezomib in treating patients who have     recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes     necessary for tumor cell growth   "
166029|NCT00006786|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Bevacizumab may stop the growth of colorectal cancer by stopping     blood flow to the tumor.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     bevacizumab in treating patients who have advanced colorectal cancer.   "
166030|NCT00006799|"     RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in     limiting weight loss caused by cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting     weight loss and improving quality of life in patients who have head and neck cancer and are     undergoing radiation therapy.   "
166031|NCT00006812|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who     have recurrent ovarian epithelial or primary peritoneal cavity cancer.   "
166033|NCT00006864|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer     cells.      PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who     have metastatic kidney cancer.   "
166035|NCT00006890|"     RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the     tumor. Prednisone may be effective in preventing relapse of multiple myeloma.      PURPOSE: Randomized phase II trial to compare the effectiveness of two doses of thalidomide     combined with prednisone following peripheral stem cell transplantation in treating patients     who have multiple myeloma.   "
166036|NCT00006903|"     This phase II trial is studying fulvestrant to see how well it works in treating patients     with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the     growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the     uptake of estrogen by the tumor cells.   "
166037|NCT00006916|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by bleomycin     in treating adult patients who have newly diagnosed supratentorial glioblastoma multiforme.   "
166038|NCT00006929|"     Phase II trial to study the effectiveness of combining suramin, paclitaxel, and carboplatin     in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Drugs used     in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than one drug may kill more tumor cells.   "
166039|NCT00006942|"     Phase II trial to study the effectiveness of combining bryostatin 1 and cisplatin in treating     patients who have advanced recurrent or residual ovarian epithelial, fallopian tube, or     primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die. Combining more than one drug may kill more tumor     cells.   "
166040|NCT00006968|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with donor peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of pentostatin followed by peripheral     stem cell transplantation in treating patients who have advanced kidney cancer.   "
166041|NCT00006981|"     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.     Immunotoxin therapy may be an effective treatment for advanced cancer.      PURPOSE: Phase I trial to study the effectiveness of immunotoxins in treating patients who     have advanced cancer.   "
166042|NCT00006994|"     RATIONALE: Glutamine may be effective in decreasing side effects, such as inflammation of the     mouth and throat, caused by radiation therapy. The effectiveness of glutamine for mucositis     is not yet known.      PURPOSE: Randomized phase III trial to determine the effectiveness of glutamine in treating     patients who develop mucositis following radiation therapy for newly diagnosed cancer of the     mouth or throat.   "
166043|NCT00007007|"     RATIONALE: Assessment of patients undergoing radiation therapy may help to determine the     effects of the treatment and may help improve cancer treatment.      PURPOSE: This clinical trial is studying the memory skills in patients receiving radiation     therapy for brain metastases.   "
166044|NCT00007020|"     OBJECTIVES:      I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate     treatment to patients with identified inborn errors of bile acid synthesis and metabolism      II. To assess the safety and tolerability of cholic acid   "
166045|NCT00007033|"     OBJECTIVES:      I. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin     D and reduced bone density in children with chronic cholestatic liver disease.   "
166046|NCT00007046|"     OBJECTIVES: I. Identify and characterize the gene causing diaphyseal medullary stenosis with     malignant fibrous histiocytoma of the bone.      II. Determine the clinical manifestations of this disease in these patients.   "
166047|NCT00007059|"     OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization     on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic     liver transplantation.      II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate     dehydrogenase activity in these patients.   "
166048|NCT00007085|"     To determine the value of contrast enhanced spiral computed tomography (spiral CT) for the     diagnosis of acute pulmonary embolism (PE).   "
166049|NCT00007098|"     To define the relation of insulin resistance during childhood and adolescence to the     development of the insulin resistance syndrome in young adulthood.   "
166050|NCT00007111|"     To track blood pressure from childhood through adolescence.   "
166051|NCT00007124|"     This study will examine the effect of a restricted-carbohydrate diet (ketogenic diet) on     Lafora disease-a severe neurological disease in which brain cells die because of abnormal     accumulation of glucose (a type of sugar). Patients with Lafora disease have rapid     neurological deterioration with myoclonus (brief muscle jerks), seizures and mental decline.     At present there is no treatment to halt disease progression.      Patients 10 years of age and older with relatively advanced Lafora disease may be eligible     for this study. Participants will be admitted to the Clinical Center for the first 4 weeks of     this 6-month study for baseline testing and to start the ketogenic diet. They will have a     complete medical history and physical examination, plus a detailed neurological examination     and blood and urine tests. Procedures include:        -  Magnetic resonance imaging (MRI) brain scans to provide information about brain          chemistry        -  Lumbar puncture (spinal tap) to analyze chemicals in cerebrospinal fluid        -  Metabolic and endocrinological tests, including a glucose tolerance test, to evaluate          the body's response to a large intake of oral glucose        -  Standard neuropsychological tests        -  Magnetic resonance spectroscopy of the brain and muscle        -  Electroencephalography (EEG) to measure brain wave activity        -  Electromyography (EMG) to measure muscle activity        -  Evoked potentials (SEP and VEP) to study brain responses to mild electric or visual          stimulation.      Transcranial magnetic stimulation (magnetic stimulation of the brain) may also be done to     study the function of the brain cortex (outer nervous tissue of the brain) and the effects of     treatment on brain excitability.      The ketogenic diet will begin after the tests are completed. The diet provides mainly fats to     fuel the body, plus the recommended amount of protein and minimum carbohydrate. Vitamin and     mineral supplements are provided to meet daily requirements. After 2 weeks on the diet, the     patient will be discharged from the hospital and seen daily as an outpatient for another 1 to     2 weeks. During this time the patient or caregiver is trained in preparing the ketogenic     diet, and then the patient is discharged to home. Throughout the study, disease symptoms will     be assessed using standardized rating scales. Blood and urine tests will be done as needed,     as will follow-up brain imaging, neuropsychological and neurophysiological evaluations.      A skin and/or muscle biopsy may be done at the first clinic visit to grow skin cells in     culture and to analyze the skin and muscle under a microscope. The biopsy area is numbed with     an anesthetic and a small piece of tissue is removed either with a needle, an instrument     similar to a cookie-cutter or a knife. The skin cells may be used for metabolic studies and     to obtain DNA for genetic testing.      At the end of the study, patients who responded well to the treatment with no significant     adverse side effects may continue the diet for another 12 months. They will be followed at     3-month intervals to monitor side effects and treatment response.   "
166052|NCT00007137|"     This study will use magnetic resonance imaging (MRI) and ultrasound to examine changes in     tongue volume and blood circulation during tongue exercises that require the use of different     tongue muscle movements and contractions. More information on the structure and function of     the human tongue is needed to develop better treatments for people with certain diseases     affecting speech and swallowing.      Normal volunteers between 21 and 80 years old who live in the metropolitan Washington, D.C.,     area may be eligible for this study. Candidates will be screened with a brief medical history     and physical examination, including suitability for MRI testing, and a brief examination of     tongue, lip and jaw movements.      Participants will undergo ultrasound and MRI studies. During both tests, they will perform     tongue exercises, such as holding a soft round object on the tongue or exerting tongue     pressure against the back of the throat or roof of the mouth.      During the ultrasound, the subject lies on a flattened dental chair. A small transducer is     placed under the chin to take images of the tongue during the exercises. A thin rubber strip     with air-filled pressure bulbs is attached to the roof of the mouth (with dental adhesive) to     measure tongue pressure.      For the MRI, the subject lies on a table that slides inside a donut's machine containing a     magnetic field. MRI coils-special padded sensors that improve image quality-are placed around     the head and neck. A pressure cuff placed around the arm measures blood pressure. The subject     wears earplugs to muffle loud thumping noises that occur during electrical switching of the     magnetic fields. The subject is in constant visual contact with the researchers and MR     technologist and may request to stop the study at any time.      Participants may undergo another procedure, called magnetic resonance diffusion tensor     imaging, to examine how the fluid (water) in the tongue tissue shifts during tongue     maneuvers. This procedure is essentially the same as the first MRI study, but two small round     coils are placed in the mouth (one on each side) between the cheeks and the teeth.   "
167624|NCT00030043|"     This is a study to gather some information on the safety and efficacy of the penetrating     auditory brainstem implant (PABI) in patients with neurofibromatosis type 2.   "
166437|NCT00014625|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of E7070 in treating patients who have     stage IV melanoma.   "
166053|NCT00007150|"     This study will evaluate the effectiveness of a test called MCV in guiding phlebotomy (blood     drawing) therapy in patients with hemochromatosis an inherited disorder that causes too much     iron to be absorbed by the intestine. The excess damages body tissues, most severely in the     liver, heart, pancreas and joints. Because iron is carried in the hemoglobin of red blood     cells, removing blood can effectively lower the body s iron stores.      Patients with hemochromatosis undergo weekly phlebotomy treatments (1 pint per session) to     deplete iron stores. This usually requires 10 to 50 treatments, after which blood is drawn     every 8 to 12 weeks to prevent a re-build up of iron. A test that measures ferritin a protein     involved in storing iron is commonly used to guide phlebotomy therapy in hemochromatosis     patients. This study will compare the usefulness of the ferritin test with that of MCV, which     measures red blood cell size, in guiding phlebotomy therapy. In addition, the study will 1)     examine whether keeping iron levels low during maintenance therapy can help heal severe liver     disease and improve arthritis in affected patients, and 2) design a system for making blood     collected from hemochromatosis donors available for transfusion into other patients.      Patients 15 years and older with diagnosed hemochromatosis or very high iron levels     suggesting possible hemochromatosis may be eligible for this study. Candidates will have a     history, physical evaluation, review of medical records and blood tests, and complete a     symptoms questionnaire. Participants will have the following procedures:        -  Phlebotomy therapy every 1 to 2 weeks, depending on iron levels        -  Blood sample collection for blood cell counts and iron studies at every phlebotomy          session        -  Blood sample collection (about 2 tablespoons) every 1 to 2 weeks after iron stores have          been depleted        -  Phlebotomy every 8 to 12 weeks after iron stores are used up to prevent re-build up of          excess iron      With each blood donation that will be made available for transfusion to other patients,     participants will answer the same health history screening questions and undergo the same     blood tests given to all regular volunteer blood donors. These include screening for the HIV     and hepatitis viruses and for syphilis.      Patients who meet height and weight requirements may be asked to consider double red cell     donations using apheresis. In this procedure, whole blood is collected through a needle     placed in an arm vein, similar to routine phlebotomy. The blood then circulates through a     machine that separates it into its components. The red cells are removed and the rest of the     blood is returned to the body, either through the same needle or through a second needle in     the other arm. Patients who have very high iron levels or an enlarged liver will be offered     evaluation by the NIH Liver Service. Those judged to be at increased risk for cirrhosis may     be advised to undergo a liver biopsy. If cirrhosis is found, the patient will be asked to     consider a repeat biopsy after 3 to 5 years of continuous iron depletion to see if scarring     has improved. Patients with arthritis will be offered evaluation by the NIH Arthritis Service     and, depending on symptoms, may be advised to have X-ray studies or a joint biopsy.   "
166054|NCT00007163|"     This study will examine the safety and effectiveness of an experimental drug called J695 for     treating patients with Crohn's disease-a long-term recurring inflammation of the small and     large intestine. This disease is currently treated with steroids, sulfasalazine (Azulfidine),     5-ASA drugs (Pentasa, Asacol), immune suppressants, antibiotics, and an antibody against     TNF-alpha. Despite the number and variety of available therapies for Crohn's disease, many     patients do not respond adequately to treatment or they develop severe side effects from the     medicines. Therefore, new treatments must be developed. J695 is an antibody that is identical     to a human antibody but chemically changed so that it can attach to and eliminate an     inflammatory chemical made by the body called interleukin-12 (IL-12). Animal studies have     shown that eliminating IL-12 with an antibody can prevent inflammation in the gut and can     also heal inflammation that has already developed.      Patients 18 years of age and older who have had Crohn's disease for at least 4 months may be     eligible for this study. Candidates will be screened with a medical history and physical     examination, electrocardiogram, chest X-ray, blood and urine tests, stool analysis and     possibly a review of medical records. They will complete a Crohn's Disease Activity Index     Questionnaire for 7 days. Participants will be randomly assigned to one of two treatment     groups, as follows:      Group 1      Patients in this group will receive an injection of either J695 or placebo (a solution that     does not contain any active medicine) under the skin on day 1 of the study, on day 29, and     then weekly for a total of seven injections. After the last injection, patients will be     followed for an additional 18 weeks. They will be monitored periodically throughout the study     with physical examinations, disease activity index scores, and blood and urine tests.      Group 2      Patients in group 2 will receive an injection of J695 or placebo on day 1 of the study and     then weekly for a total of six injections. They will be followed for an additional 18 weeks.     Patients will be monitored as described above for group 1.      Participants may be asked to undergo additional tests as part of a sub-study in this     protocol. These include colonoscopies to examine changes in inflammation in the gut and blood     tests to analyze changes in the cells and body chemicals that affect the inflammation.   "
166055|NCT00007189|"     The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory     medications naproxen and celecoxib to delay or prevent the onset of AD and age-related     cognitive decline.   "
166056|NCT00007202|"     The purpose of this study is to determine the safety and effectiveness of stavudine (d4T),     didanosine (ddI), and BMS-232632 when given early in the course of HIV infection.      Acute HIV infection may develop in patients that are exposed to the HIV virus. Following     infection, the viral load (level of HIV in the blood) rises rapidly over the next few days to     weeks. It is not known which is the best treatment in patients with very early HIV infection.     Researchers believe these patients may respond well to strong early treatment. A combination     consisting of enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease     inhibitor, BMS-232632, will be tested.   "
166057|NCT00007215|"     This study will use a newly developed instrument called dynamic light scattering device (DLS)     to examine age-related changes in the human lens and to study the causes and development of     cataracts. DLS uses a low intensity laser light (similar to that used in supermarket     checkouts) to measures lens cloudiness. It detects changes in the human lens at the earliest     stages, when anti-cataract treatment would be most effective in reversing, delaying or     preventing cataract formation.      Patients 18 years of age and older with cataracts and normal volunteers between the ages of     18 and 70 years may be eligible for this study. Participants will have a standard eye     examination, including a vision check, pressure measurement, lens examination using DLS and     examination of the retina. Photographs of the lens or retina, or both, may be taken.      This study does not involve treatment. No anti-cataract medications will be given.   "
166058|NCT00007228|"     The purpose of this study is to learn about heart and skeletal muscle problems related to     neuroacanthocytosis (also called Mcleod's syndrome and Levine-Critchley disease). This     inherited condition causes problems of blood, brain, heart and muscle function. About 60     percent of patients have an unusual heart muscle abnormality that increases the risk of     sudden death. Although the molecular (genetic) changes responsible for neuroacanthocytosis     have recently been identified, the heart and skeletal muscle problems are not well     understood. This study will try to correlate the specific genetic abnormalities with the     clinical features of the disease and identify possible causes of sudden death.      Patients and first degree relatives of patients with neuroacanthocytosis 18 years of age or     older may be eligible for this study. Participants will be admitted to the National     Institutes of Health Clinical Center for 2 to 5 days for the following tests:        -  Electrocardiogram - to measure the electrical function of the heart        -  Echocardiogram - uses ultrasound to measure heart thickness and detect heart vessel          obstructions        -  Cardiac magnetic resonance imaging (MRI) - uses a magnetic field and radio waves to          provide pictures of the heart for measurements of muscle thickness and muscle function        -  Exercise testing on a stationary bicycle - to measure and record symptoms during          exercise, exercise duration, heart rate and blood pressure, oxygen consumption and          aerobic threshold        -  Holter monitoring - uses a device attached to the chest for continuous recording of          heart rhythms        -  Blood tests - to look for muscle damage, to exclude other causes of muscle disease, and          to perform DNA (genetic) testing        -  Neurological consultation - to test muscle function, coordination and tests of certain          brain functions such as memory and concentration      Patients with evidence of muscle disease may also undergo a muscle biopsy. This is done under     a local anesthetic and possibly small amounts of sedation. A small area of skin over a large     arm muscle (biceps) is numbed, a short incision is made and a small sample of muscle tissue     is removed for microscopic examination.      Patients with evidence of heart disease may also undergo the following additional tests:        -  Cardiac catheterization and electrophysiological study - to determine the extent of          heart disease and study abnormal heart rhythms. Cardiac catheterization is done under          mild sedation. The groin is numbed with an anesthetic and catheters (thin plastic tubes)          are inserted and passed through the blood vessels into the chambers of the heart.          Pressures inside the heart are measured and pictures may be taken of the heart arteries.          During this procedure an electrophysiology test may be done to study abnormal heart          rhythms.        -  Cardiac biopsy - to examine heart muscle tissue. This may be done at the end of the          cardiac catheterization. Small samples of heart muscle are obtained using a fine          instrument passed through the catheter in the groin.      Family members who do not have signs of heart or muscle disease will only undergo     non-invasive tests. All participants will be given the results of all tests and treatment     options will be discussed.   "
166059|NCT00007241|"     Studies have shown that isometric strengthening helps people with osteoarthritis of the knee.     Isometric strengthening is muscle-strengthening exercise without movement, in which a person     applies a force against a resistant object--for example, pushing against a brick wall. This     study will test the effectiveness of a portable isometric exercise device for home use that     guides a person through an exercise program using various forms of feedback. We will look at     whether people exercising with the device achieve better outcomes (results) in pain,     stiffness, strength, and functional measures compared to people who do not use the device or     people exercising according to printed material from arthritis organizations.   "
166060|NCT00007254|"     This study tests the effectiveness of a morphine-containing gel for reducing pain caused by     pressure ulcers, also known as bedsores or pressure sores. We will apply the gel containing     morphine, or the gel alone, directly onto painful pressure ulcers and compare the results.   "
166061|NCT00007267|"     This study will examine the effectiveness of two psychological treatment approaches designed     to help people who have scleroderma with three important areas of daily living: pain,     depression, and distress about changes in appearance. The study will also evaluate the impact     of depression on the two psychological treatments. Because psychological approaches requiring     a trained professional can be expensive and are often not available to most patients, this     study will also look at the effectiveness of a self-help treatment approach.   "
166099|NCT00007800|"     This clinical trial examines whether the addition of individual sessions of a motivational     intervention to a state-of-the art behavioral group weight loss intervention for overweight     women with Type 2 diabetes improves the weight losses and glycemic control outcomes.   "
166062|NCT00007280|"     This study will look at whether a graft of bioengineered skin (BSC), known commercially as     Apligraf, stimulates the healing process in a person's own skin at the edge of a wound (known     as the edge effect). The information from this study will provide a better understanding of     the ways that grafts of bioengineered skin help the healing of chronic wounds.      We will assign study participants to either the bioengineered skin group or the control     group. People in the control group will receive compression therapy with a multilayered     compression bandage. We will examine each participant before starting treatment and then once     a week for 24 weeks or until the wound heals. On the first day of treatment (day 0) and at     week 3, week 6, and week 24 (end of treatment) we will take a small tissue sample from the     wound for a biopsy. After the wound is completely healed, we will ask the patient to return     once a month for 6 months to make sure the wound stays healed.   "
166063|NCT00007293|"     This study will test the safety and effectiveness of a novel fiber optic device for treating     scalp psoriasis with ultraviolet (UV-B) light. A effective treatment is not currently     available for people with scalp psoriasis. Present methods for treating psoriasis with UV-B     light cannot be used for the scalp because hair is usually blocking the light from reaching     the affected skin. Our method overcomes this problem with the use of a comb that has optical     fibers to deliver light directly to the skin. We will evaluate this device in a clinical     setting and will use the results to tailor the design of the comb before producing it in     large quantities.   "
166064|NCT00007306|"     This is a clinical study in two phases. The first phase compares the effect of an ointment     containing parathyroid hormone (PTH) with the effect of a placebo ointment (inactive ointment     without PTH) on psoriasis lesions. Neither the study participants nor the researchers will     know who is receiving PTH ointment and who is receiving placebo until the end of this first     study phase. The second phase is a study of the PTH ointment on large areas of psoriasis to     find out how long the effects last.   "
166065|NCT00007319|"     The intima-media thickness (IMT) test is a low cost, non-invasive way to measure the     thickness of the carotid artery (the large artery in the neck). The purpose of this study is     to compare the thickness of the carotid artery among HIV infected adults taking protease     inhibitors (PIs), HIV infected adults not taking PIs, and HIV uninfected adults, and to     examine how the thickness may change over time.   "
166066|NCT00007332|"     The purpose of this study is to see if the vaccines tested are safe when given alone and when     given together, and how the immune system responds to the vaccines.      Vaccines are given to people to try to prevent an infection or disease. Early testing in a     few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to     use.   "
166067|NCT00007345|"     Background:      NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent     cytotoxic activity against human tumor cell lines and in vivo efficacy against both human     tumor xenografts and murine tumors (1-3).      NSC 630176, herein referred to as depsipeptide, shows a lack of cross resistance with several     commonly used cytotoxic agents such as vincristine, 5-fluorouracil, mitomycin C and     cyclophosphamide (2). However, it has been defined as a P-glycoprotein (Pgp) substrate by     COMPARE analysis of the National Cancer Institute (NCI) drug screen cytotoxicity profile (4).      Depsipeptide is a member of a novel class of antineoplastic agents, the histone deacetylase     inhibitors.      In the phase I trial conducted at the National Cancer Institute (NCI), responses were     observed at the maximum tolerated dose (MTD) in patients with cutaneous and peripheral T-cell     lymphoma.      Objectives:      In patients with cutaneous T-cell lymphoma, the primary end points to be examined are overall     response rate, complete response rate and duration of response.      In patients with relapsed peripheral T-cell lymphoma, the endpoints to be examined are     overall response rate and complete response rate.      To evaluate the tolerability of depsipeptide with extended cycles of therapy.      Eligibility:      Patients with cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) or other     peripheral T-cell lymphomas are eligible.      Design:      Depsipeptide will be administered at 14 mg/m^2, over 4 hours on days 1, 8 and 15.      This trial will accrue in six cohorts; Arm 1, patients with cutaneous T-cell lymphoma who     have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 2, patients     with peripheral T-cell lymphoma who have had less than or equal to two prior cytotoxic     chemotherapy regimens; Arm 3, patients with cutaneous and peripheral T-cell lymphoma who have     had more than two prior cytotoxic chemotherapy regimens; Arm 4, patients with other mature     T-cell lymphomas; Arm 5, a replicate arm of arm 1; Arm 6, patients with peripheral T-cell     lymphoma who have had more than two prior cytotoxic chemotherapy regimens; Arm 7, patients     with cutaneous T cell lymphoma who have received vorinostat.      Dose may be adjusted based on toxicities.   "
166068|NCT00007358|"     Some newborns are born with congenital heart block (CHB), a condition occurring in babies     with neonatal lupus. The first part of the study will test the effectiveness of fluorinated     steroids, including dexamethasone, in improving the heart function and general health of     newborns who have auto-antibody-associated CHB. The second part of this study will use     ultrasound and heart monitoring to observe high-risk pregnant women and their fetuses during     the third trimester of pregnancy.   "
166069|NCT00007371|"     To define the natural history, immunologic, and genetic factors that influence the clinical     outcome of hepatitis C in a cohort of hemophilic siblings.   "
166070|NCT00007384|"     To longitudinally investigate multigenerational familial clustering of plasma low density     lipoprotein cholesterol (LDL-C), with particular emphasis on the influences of apoE genotypes     and various 'behaviors'.   "
166071|NCT00007397|"     To relate cardiovascular disease (CHD) risk factors to cognitive performance among     middle-aged and elderly men and women over a 10 year longitudinal study period.   "
166072|NCT00007410|"     To determine the effects of six genes on thrombotic risk factors known to be associated with     the development of heart disease.   "
166073|NCT00007423|"     The purpose of this study is to see if it is safe to give ALVAC-HIV vCP205, a possible HIV     vaccine, and to study the immune responses in adult HIV-1 uninfected volunteers.      Uganda has been severely affected by HIV infection and AIDS and has been selected to     participate in HIV-vaccine development. The HIV viruses commonly isolated from Uganda are 2     kinds that are not used in making current vaccines. Current vaccines generate several kinds     of immune responses. Researchers would like to see if a response to the kind of virus in a     current vaccine will also protect people from the viruses commonly found in Uganda.   "
166074|NCT00007436|"     The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate     (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in     other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at     different doses, and may benefit from having tenofovir DF treatment.   "
166075|NCT00007449|"     The purpose of this study is to determine the safety and tolerability of the study drug DPC     083 combined with 2 nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected     patients who are failing their nonnucleoside reverse transcriptase inhibitor (NNRTI)     treatment.      In some studies DPC 083 (an NNRTI) has been found to lower the amount of HIV in the blood     (viral load), where drug-resistant types of HIV were not lowered by other NNRTIs. This study     will attempt to determine how safe DPC 083 is when it is taken in combination with 2 NRTIs.   "
166076|NCT00007475|"     Focal segmental glomerulosclerosis (FSGS) is a renal syndrome characterized by proteinuria     (usually nephrotic range), limited response to conventional therapy, and a poor renal     prognosis, with progression to end stage renal failure in at least 50% of patients. As a     syndrome, FSGS likely has many specific etiologies, only a few of which are well-defined.     Recently, it has been suggested that some idiopathic FSGS patients have elevated circulating     levels of a protein that induces glomerular permeability in vitro and in vivo. While there     has been no consistent term for this factor, it will be termed here FSGS permeability factor     (FPF).      The purposes of the present study are five fold:        1. To identify a population of FSGS patients with elevated FPF levels        2. To examine RNA expression profiles of peripheral blood mononuclear cells (PBMC) in FSGS          patients with elevated FPF levels        3. To define the kinetics of FPF disappearance and reappearance in FSGS patients receiving          immunomodulatory therapy and in the case of patients with recurrent FSGS following renal          transplant, those receiving plasma exchange        4. To identify immunosuppressive agents which are successful in inducing sustained          reduction in FPF levels        5. To determine in patients with FSGS who are awaiting renal transplant, whether sustained          reduction in FPF levels is associated with reduced risk of recurrent FSGS.      Patient participation is divided into an evaluation phase, in which FPF levels, RNA     expression profiles, and patient eligibility for participation in treatment protocols are     determined, and a treatment phase in which specific immunomodulatory therapy is introduced in     an open label fashion. We propose to define carefully the relationship between elevated FPF     and remission of proteinuria in patients with FSGS in native kidneys, following treatment     with standard therapies (daily prednisone, cyclophosphamide) and experimental therapies     (pulse dexamethasone, pirfenidone). In patients with recurrent FSGS in renal allografts, we     will determine the kinetics of FPF following plasma exchange and following plasma exchange     plus cyclophosphamide. In patients with elevated FPF levels who are awaiting renal     transplantation, we will determine the kinetics of FPF following plasma exchange and     following plasma exchange plus cyclophosphamide, and examine the rate of recurrent FSGS in     these patients.   "
166077|NCT00007488|"     The purpose of this study is to gain information on how the type and amount of HIV present in     certain places in the body and in the blood are affected when potent (powerful) anti-HIV     drugs are given.      Researchers know that the type and amount of HIV may differ in certain places in the body     (called compartments) but are not sure how anti-HIV treatment affects these differences. This     study gathers information to help understand how the virus grows and changes between blood     and nonblood compartments in patients receiving anti-HIV treatment.   "
166078|NCT00007501|"     The incidence and severity of HZ (or shingles), as well as the frequency and severity of its     complications, increases markedly with increasing age. More than half of all cases occur in     persons over the age of 60. Even without complications, HZ can interfere with an elderly     patient's ability to perform essential activities of daily living, resulting in a loss of     independence that is emotionally devastating and frequently irreversible. The most common     complication of HZ in elderly persons is postherpetic neuralgia (PHN), which frequently     results in disordered sleep, chronic fatigue, anxiety and severe depression. Antiviral     therapy has a modest impact on the acute phase of HZ. However, it does not appear to prevent     the development of PHN.      This study is a 5.5 year randomized, double-blind, placebo-controlled, efficacy trial to     determine whether vaccination with live-attenuated Oka/Merck varicella-zoster decreases the     incidence and/or severity of herpes zoster (HZ) and its complications in adults 60 years of     age and older.   "
166079|NCT00007514|"     Significant subsets of military veterans have reported such health problems as headache,     joint pain, fatigue, and memory/concentration difficulties subsequent to their participation     in the Gulf War. However, the etiology remains controversial. A number of toxins have been     implicated as etiologic factors for GW-related health problems; however, exposure levels have     been difficult, if not impossible, to document retrospectively. These difficulties with     exposure verification have led GW researchers to de-emphasize methods typical of     neurotoxicological research examining exposure-symptom relationships and instead focus on     epidemiological approaches emphasizing identification of coherent symptom patterns.   "
166080|NCT00007527|"     The CS 1018 study will recruit a total of 600 patients seeking treatment for opiate     dependence. They will be recruited from six states (Florida, New York, Texas, California,     Washington, and Illinois), with up to ten private physician sites or clinics participating in     each state. Coordination of the participating sites and clinics in each of the six states     will be performed from an associated Department of Veterans Affairs Medical Center (Tampa     VAMC, New York City VAMC, San Antonio VAMC, Long Beach VAMC, Seattle VAMC, and Hines VAMC).     The Principal Investigator (PI) at each of the six VAMC?s will be a physician experienced in     the treatment of opiate dependent patients.      Patients will be recruited by any of numerous strategies including word of mouth,     self-referral, local fliers, newspapers, and radio advertisements. This study will be     conducted open label with no random assignment or stratification. Patients may be accepted     for detoxification or longer-term treatment (6 to 12 months of buprenorphine/naloxone     therapy). Patients under the age of 21 will initially be admitted for detoxification; longer     treatment of these patients will be based on physician judgement of the necessary of     continued treatment. Patients will be inducted directly into buprenorphine/naloxone 4:1     combination tablets. Patients treated in private practice will be asked to sign a treatment     contract which will delineate the terms and conditions of treatment.   "
166081|NCT00007540|"     Prostate cancer is diagnosed in approximately 334,500 men each year and accounts for nearly     41,800 deaths in the United States. Prostate cancer is the leading cancer affecting veterans     and the second leading cancer among all Americans. The causes of prostate cancer and,     particularly, the reasons for the unusually high incidence rates in African-Americans remain     obscure. Dietary factors likely play a role in fatal cases, while hormones are also important     in regulating prostate cancer growth. Dr. Charles Huggins recognized this effect in the     1940?s, with androgen deprivation remaining as the cornerstone of therapy for advanced     disease. Despite the strong circumstantial evidence, neither epidemiologic studies nor basic     sciences have produced clear insight into the etiologic role of hormones. However, recent     observations regarding androgen receptor gene polymorphisms and their relation to endocrine     expression and prostate cancer risk may be providing important clues as to how an etiologic     role might be mediated at the molecular level. Thus, it is important to attempt to identify     genetic markers of high-risk cancer patients for necessary screening and counseling efforts.   "
166090|NCT00007683|"     Whether patients with chronic heart failure (CHF) should be anticoagulated is one of the     oldest unresolved questions in cardiovascular therapeutics. Some authorities do not recommend     anticoagulation for CHF patients in sinus rhythm, others recommend anticoagulation in     patients with primary cardiomyopathy, and still others consider it more appropriate in     patients with coronary artery disease (CAD). This absence of consensus reflects the lack of     evidence in this area and different outlooks on the objectives of such therapy (e.g.,     prevention of arterial emboli or reduction in vascular events).   "
166579|NCT00016939|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who     have unresectable or metastatic kidney cancer.   "
166082|NCT00007579|"     Primary Objectives: To explore racial differences in potential risk factors for developing     prostate cancer in the VA population and to compare and contrast the results of this study     with that of an ongoing NCI-funded study in North Carolina.      Secondary Objectives: To investigate familial aggregation of prostate cancer in blacks and     whites. To determine whether screening behavior differs in men diagnosed with early stage     prostate cancer versus those with later stage disease as well as to determine if screening     behavior differences exist between blacks and whites.      Primary Outcomes: The primary outcomes are pesticide, occupational and chemical exposure, and     dietary history. Other major endpoints include: 1) familial aggregation of prostate cancer;     2) weight, weight history, and weight cycling; 3) subject's knowledge, attitudes, and     behaviors about prostate cancer; and 4) treatment choices.      Intervention: N/A      Study Abstract: Prostate cancer is the most commonly diagnosed cancer in American men. Among     African Americans the incidence and mortality from prostate cancer is even greater. Although     incidence rates in the Southern United States tend to be only slightly higher than that of     the nation, a clear discrepancy exists between national mortality rates and those in the     Southeastern United States. Notably high rates, particularly among African Americans are     observed and in North Carolina the prostate cancer mortality rate among African Americans is     the highest of any state in the nation. In spite of these statistics, very little is known     about racially based differences in the etiology of this disease.      This study hypothesizes that racial differences in the incidence and mortality of prostate     cancer may be a result of multiple factors including those that are socioeconomic,     environmental, dietary and genetic. This research will provide insight into     gene-environmental interactions that initiate and promote prostatic neoplasia as well as     address whether there are differences in patterns of care which impact morbidity and     survival. The results of this study will also be compared to findings in non-veterans that     are being generated through an NCI-funded sister study of these issues under the direction of     co-investigator, Dr. JoEllen Schildkraut of Duke University.      Subjects were identified from pathology reports extracted from VISTA. Additionally, subjects     were identified by reviewing radiation/oncology clinic records for those subjects referred     for radiation treatment. Subject enrollment concluded with 100 cases and 98 controls enrolled     in the study   "
166083|NCT00007592|"     Hypertension is one of the most common medical problems in the United States and in the VA     health care system. It has been well-documented that hypertension can be effectively treated.     However, there remain important unresolved clinical questions in the area of antihypertensive     treatment. For example, how much is mortality affected by visit compliance, blood pressure     control and type of antihypertensive agent? Or, are some regimens associated with more     morbidity than others? Or, are there inexpensive regimens that are as effective as more     expensive regimens? The amount of data that is available from this demonstration project     (currently 6,100 patients) will help address these questions. The answers to these questions     should result in better care for veterans with hypertension.   "
166084|NCT00007605|"     Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million     cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of     the latter occurring annually in patients with atrial fibrillation. The safety of the most     widely used antiarrhythmic agent for this group of patients, quinidine, has been called into     question. This study seeks to determine whether two other agents, amiodarone and sotalol, are     safe and effective treatments for patients with atrial fibrillation.   "
166085|NCT00007618|"     Colorectal cancer is the second leading cause of cancer death in the United States each year.     Approximately one million veterans aged 50 and older will develop colorectal cancer over the     remainder of their lives and nearly 433,000 will die from it. Because most cancers are     diagnosed after local or regional spread, nearly half of all patients diagnosed with     colorectal cancer will die. On a national basis, the relative five year survival with     colorectal cancer was estimated at approximately 40% among veterans, substantially lower than     SEER estimates in the general population of 61.7% (colon) and 59.3% (rectum). Colorectal     cancer is preventable through screening, however and, if diagnosed in an early stage (Dukes'     A and B), is curable.      This is the first study to examine factors that might explain the worsened prognosis for     veterans with colorectal cancer. If modifiable factors such as physician and patient delay in     diagnosis, or poverty, explain the increased mortality among veterans, educational programs     and interventions that improve the process of care associated with screening and diagnosis     can be instituted.   "
166086|NCT00007631|"     One-third of all malignancies in the United States (approximately one million cases diagnosed     annually) are nonmelanoma skin cancer (NMSC). NMSC causes considerable morbidity, economic     burden, facial deformity and at least 1,000 deaths annually. Prevention of these malignancies     with a topical agent free of serious side effects would confer substantial public health     benefit. Three hundred fifty thousand veterans were expected to develop NMSC in 1994. NMSC is     one of the most common conditions requiring dermatologic care in the VA system. Topical     tretinoin has been used extensively to treat photoaged skin. Retinoids administered orally in     high doses appear to be effective in chemoprevention of nonmelanoma skin cancer but have     unacceptable toxicity. In this study, 1131 patients with a recent history of squamous cell     and/or basal cell carcinoma were enrolled at six participating centers over a four-year     period and were randomly assigned to either 0.1% tretinoin cream or placebo. They were     followed for a minimum of two years to determine if topical tretinoin is effective in     reducing the risk of new occurrences.   "
166087|NCT00007644|"     Radical prostatectomy provides potentially curative removal of the cancer. However, it     subjects patients to the morbidity and mortality of the surgery and may be neither necessary     nor effective. Expectant management does not offer potential cure. However, it provides     palliative therapy for symptomatic or metastatic disease progression, avoids potentially     excessive and morbid interventions in asymptomatic patients, and emphasizes management     approaches for focus on relieving symptoms while minimizing therapeutic complications.      The primary objective of this study is to determine which of two strategies is superior for     the management of clinically localized CAP: 1) radical prostatectomy with early aggressive     intervention for disease persistence or recurrence, 2) expectant management with reservation     of therapy for palliative treatment of symptomatic or metastatic disease progression.     Outcomes include total mortality, CAP mortality, disease free and progression free survival,     morbidity, quality of life, and cost effectiveness.   "
166088|NCT00007657|"     PCI (optimal catheter-based coronary revascularization) + intensive medical therapy is     superior to intensive medical therapy alone using the combined endpoint of all-cause     mortality or nonfatal MI.   "
166089|NCT00007670|"     New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These     patients are especially vulnerable to side effects from medications because of changes caused     by the aging process and the fact that these patients often have many common diseases for     which they are already receiving medications for so that the likelihood of drug interactions     is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the     FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of     partial onset seizures, the most common seizures in the elderly. These new compounds also     have favorable side effect profiles and infrequent drug-drug interactions and, therefore,     would be expected to be well-tolerated in the elderly.   "
166091|NCT00007696|"     Population-based screening for diabetes mellitus in non-pregnant adults remains     controversial. For a screening strategy to be successful, patients identified by surveillance     will have to have better outcomes than if they had been diagnosed at a later, more     symptomatic phase of disease. However, little is known about the fate of patients diagnosed     with diabetes by screening. Additionally, while about half of the cases of diabetes among the     general population at any given time are undiagnosed, the prevalence of undiagnosed diabetes     among veterans is unknown. The annual incidence of diabetes among veterans is also unknown.      Assessing risk factors prior to blood testing will improve the specificity, with little cost     in sensitivity, of screening for diabetes in a medical center setting. The target population     which optimizes the potential value of diabetes screening is patients with at least 1 of the     above 3 risk factors for diabetes (obesity, hypertension, family history). Hypertension is     strongly associated with unrecognized diabetes in veterans. VA and other health care     providers considering whether to perform systematic screening for diabetes should use known     risk factors to identify an appropriate target population for screening.   "
166092|NCT00007709|"     It is suspected, but not well documented, that persons with severe mental illness (SMI)     represent a significant transmission source of serious infectious diseases. SMI diagnoses are     defined as schizophrenia, schizoaffective disorder, bipolar disorder, or posttraumatic stress     disorder (PTSD). Severely mentally ill persons are at high risk for Human Immunodeficiency     Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS). To assess the risk of HIV and related     infections among these individuals, the National Institute of Mental Health (NIMH) Office on     AIDS funded the HIV/SMI five site collaborative study Assessing HIV/AIDS and Associated     Health Risks in People with Severe Mental Illness. This Durham ERIC study supplements the     NIMH HIV/SMI study with a four-year longitudinal cohort study of 300-plus SMI veterans in     order to estimate the prevalence of HIV risk behaviors and HIV infection, as well as to     measure utilization of health services over time. The Durham VA is the only VA site     represented in the study and is collaborating with four non-VA sites including Dartmouth,     University of New Hampshire, University of Connecticut and Duke University. As such, we have     the additional goals of investigating health and health-care-service issues relevant to     veterans with SMI and of establishing a database for the longitudinal study of veterans with     SMI.   "
166093|NCT00007722|"     Recently, concern has arisen regarding a possible elevated occurrence of ALS among veterans     who served in the Persian Gulf during Operations Desert Shield (August 2, 1990 - January 15,     1991), Desert Storm (January 16, 1991 - February 28, 1991) and Clean-up (March 1, 1991 - July     31, 1991). This study involves an epidemiologic investigation into the occurrence of ALS     among veterans of the Gulf War. This study will further define the epidemiology of this     neurological disease among younger individuals while determining whether there is a higher     than expected occurrence. It will also ascertain the etiologic importance of deployment to     the Persian Gulf and exposure to specific environmental factors in that geographic area. VA     is leading this joint federal government epidemiologic study that also involves DoD, HHS,     CDC, and academic centers of excellence in neurology, with advice from the ALS Association.   "
166094|NCT00007735|"     In 1990 and 1991, the U.S. deployed approximately 700,000 troops to the Persian Gulf to     liberate Kuwait from Iraqi occupation. While there were few casualties associated with the     Gulf War, many individuals returned from this conflict with unexplained symptoms and     illnesses. This constellation of symptoms has been termed Gulf War Veterans' Illnesses (GWI).     Although several explanations have been offered as to the cause of GWI, none of the putative     etiologic agents or conditions is currently supported by sufficient evidence. One explanation     that has received fairly widespread attention is systemic Mycoplasma fermentans infection. It     is the purpose of this study to determine if antibiotic treatment directed against Mycoplasma     species (i.e. doxycycline) will improve functioning and symptoms in deployed Gulf War     veterans with GWI.   "
166095|NCT00007748|"     This trial is a study of Gulf War era veterans who have unexplained chronic medical symptoms     such as pain, fatigue, and/or cognitive difficulties. The treatments to be studied, cognitive     behavior therapy (CBT) and aerobic exercise, have been shown to be effective in alleviating     symptoms in individuals with other similar types of illnesses, such as chronic fatigue     syndrome and fibromyalgia. This is a Phase 3, 2X2 factorial designed study. All study     participants are assigned to one of four treatment groups - CBT and aerobic exercise, aerobic     exercise alone, CBT alone or usual and customary care. This study durations is 28 months;     1092 participants were enrolled and will be followed in clinic at 3, 6 and 12 months after     enrollment.   "
166096|NCT00007761|"     Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized     controlled trial of a high-intensity ambulatory treatment program for bipolar disorder     against standard office-based, physician-centered care. The major characteristics of this     program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2)     continuity of care with identified primary mental health nurse clinicians supported by     psychiatrist back-up, and (3) patient education to improve treatment alliance and illness     management skills.   "
166097|NCT00007774|"     Although currently marketed antipsychotic drugs are useful in the treatment of schizophrenia,     efficacy and safety profiles need to be improved. Forty to eighty percent of patients either     fail to respond or only partially respond to conventional antipsychotic agents. Secondary     symptoms may be unimproved even in patients who respond to treatment. A variety of adverse     events occur in patients receiving currently available agents. The severity of these events     contributes to the poor compliance that is observed in this patient population. Olanzapine is     a novel antipsychotic agent with a reduced incidence of extrapyramidal symptoms. Other side     effects are minimal.   "
166098|NCT00007787|"     The purpose of this study is to see if kidney function can be improved during transplants by     giving the drug Thymoglobulin with delayed cyclosporine treatment instead of initial     cyclosporine treatment.      There have been improvements for patients receiving kidney transplants, yet acute rejection     is still a problem. This can lead to kidney failure over time. Patients whose graft fails to     function properly in the first week after transplant do not do as well after 5 years as     compared to patients without early problems. This study will see if Thymoglobulin, a drug     that suppresses the immune system, will improve early graft function.   "
176891|NCT00157677|"     The purpose of this study is to compare two diagnostic interventions to improve the way     D-dimer blood testing (MDA D-dimer) is used to diagnose first time symptomatic deep vein     thrombosis.   "
166100|NCT00007813|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy used to kill tumor cells. Drugs used in chemotherapy use different     ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy     with peripheral stem cell transplantation may allow the doctor to give higher doses of     chemotherapy drugs and kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide     when given together with combination chemotherapy and a peripheral stem cell transplant in     treating patients with malignant solid tumors.   "
166101|NCT00007826|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Vaccines made from cancer     cells may make the body build an immune response to kill colorectal tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy and/or     vaccine therapy in treating patients who have locally advanced or metastatic colorectal     cancer.   "
166102|NCT00007839|"     RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the     immune system and stop cancer cells from growing.      PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients     who have low-grade lymphoma.   "
166103|NCT00007852|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy     followed by bone marrow or peripheral stem cell transplantation in treating patients who have     relapsed or refractory non-Hodgkin's lymphoma.   "
166104|NCT00007865|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells     and either kill them or deliver cancer-killing substances to them without harming normal     cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with     rituximab in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.   "
166105|NCT00007878|"     This phase I trial studies the side effects and best dose of bortezomib when given together     with fluorouracil and leucovorin calcium in treating patients with solid tumors that are     metastatic or cannot be removed by surgery. Bortezomib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     fluorouracil and leucovorin calcium, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving bortezomib     together with chemotherapy may be an effective treatment for solid tumors.   "
166106|NCT00007891|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell     transplantation or bone marrow transplantation may be able to replace immune cells that were     destroyed by monoclonal antibody therapy used to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy     followed by bone marrow or peripheral stem cell transplantation in treating patients who have     metastatic breast cancer.   "
166107|NCT00007904|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy. Radiation therapy uses     high-energy x-rays to damage tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA     breast cancer.   "
166108|NCT00007917|"     Phase I trial to study the effectiveness of gemcitabine plus flavopiridol in treating     patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may     kill more tumor cells.   "
166109|NCT00007930|"     RATIONALE: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is     not yet known whether one type of surgery is more effective than another for rectal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in     treating patients who have rectal cancer.   "
166110|NCT00007943|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who     have advanced colorectal cancer.   "
166111|NCT00007956|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have recurrent or refractory lymphoma.   "
166112|NCT00007969|"     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to     light to kill tumor cells. Photodynamic therapy may be effective in treating melanoma.      PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy in treating     patients who have stage III or stage IV melanoma.   "
166113|NCT00007982|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell     transplant work in treating patients with central nervous system cancer.   "
166114|NCT00007995|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell     transplant work in treating patients with multiple myeloma or primary systemic amyloidosis.   "
166115|NCT00008008|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell or bone     marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill     more tumor cells.      PURPOSE: This phase II trial is studying how well thiotepa followed by peripheral stem cell     or bone marrow transplant works in treating patients with malignant glioma.   "
166116|NCT00008021|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use     different ways to stop cancer cells from dividing so they stop growing or die. Peripheral     stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill     more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy,     cyclosporine, and paclitaxel followed by peripheral stem cell transplantation in treating     patients who have refractory non-Hodgkin's lymphoma.   "
166117|NCT00008034|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells and shrink     tumors so they can be removed during surgery.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy before surgery     in treating women who have locally advanced, inflammatory, or large surgically removable     breast cancer.   "
166118|NCT00008047|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Randomized phase I/II trial to study the effectiveness of combination chemotherapy     with or without paclitaxel combined with radiation therapy in treating patients who have     stage II or stage III cancer of the esophagus.   "
166119|NCT00008060|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which regimen of combination chemotherapy is more effective for advanced colorectal     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil combined     with leucovorin and either irinotecan or oxaliplatin in treating patients who have     unresectable metastatic colorectal cancer.   "
166120|NCT00008073|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Octreotide may help doxorubicin kill more cancer cells by making     tumor cells more sensitive to the drug.      PURPOSE: Phase I trial to study the effectiveness of octreotide and doxorubicin in treating     patients who have advanced cancer.   "
166121|NCT00008086|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Calcitriol may help solid tumor cells develop into normal cells.     Combining calcitriol with chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with carboplatin in     treating patients who have advanced solid tumors.   "
166122|NCT00008099|"     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with resected or locally advanced unresectable pancreatic cancer.   "
166123|NCT00008112|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Hyperthermia therapy kills tumor cells by heating them to several degrees above body     temperature. Combining hyperthermia with radiation therapy and chemotherapy may kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of cisplatin combined with radiation     therapy and hyperthermia in treating patients who have stage II, stage III, or stage IV     cervical cancer.   "
166124|NCT00008125|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of gemcitabine combined with docetaxel and     carboplatin with or without filgrastim in treating patients who have advanced solid tumors.   "
166125|NCT00008138|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug or combining chemotherapy with surgery     may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in     treating patients who have stage III or stage IV ovarian epithelial cancer, primary     peritoneal cancer, or fallopian tube cancer.   "
166126|NCT00008151|"     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.     Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that     were destroyed by chemotherapy and radiation therapy used to kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin combined with     fludarabine and total-body irradiation followed by donor peripheral stem cell or bone marrow     transplantation in treating patients who have advanced acute myeloid leukemia or     myelodysplastic syndrome.   "
166127|NCT00008164|"     RATIONALE: Umbilical cord blood or placental blood transplantation may be able to replace     immune cells that were destroyed by the chemotherapy or radiation therapy that was used to     kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood and placental     blood transplantation in treating patients who have hematologic cancer or aplastic anemia.   "
166140|NCT00008333|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of vinorelbine taken by mouth in treating     older patients who have stage IIIB or stage IV non-small cell lung cancer.   "
166141|NCT00008346|"     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective     treatment for cancer. It is not yet known which type of mammography is more effective in     detecting breast cancer.      PURPOSE: Screening and diagnostic trial to compare the effectiveness of two types of     mammography in detecting breast cancer in women.   "
166128|NCT00008177|"     This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody     BC8 when given together with fludarabine phosphate and low-dose total-body irradiation     followed by donor stem cell transplant and immunosuppression therapy in treating older     patients with acute myeloid leukemia or high-risk myelodysplastic syndromes that cannot be     controlled with treatment. Radiolabeled monoclonal antibodies, such as iodine I 131     monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them.     Giving chemotherapy, such as fludarabine phosphate, and total-body irradiation before a donor     peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells. It     may also stop the patient's immune system from rejecting the donor's stem cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem     cells may also replace the patient's immune cells and help destroy any remaining cancer     cells. Sometimes the transplanted cells from a donor can also make an immune response against     the body's normal cells. Giving radiolabeled monoclonal antibody therapy together with     fludarabine phosphate and total-body irradiation before the transplant together with     cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.   "
166129|NCT00008190|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.     Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     peripheral stem cell transplantation and interleukin-2 in treating patients who have acute     leukemia.   "
166130|NCT00008203|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or     bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs     and kill more tumor cells. Biological therapy may interfere with the growth of the cancer     cells. It is not yet known which post-transplant biological therapy regimen is more effective     for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine and     interferon gamma to that of interleukin-2 following combination chemotherapy and bone marrow     or peripheral stem cell transplantation in women who have stage II or stage III breast     cancer.   "
166131|NCT00008216|"     RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor peripheral     blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells     from a donor are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets.      PURPOSE: This phase II trial is studying the effectiveness of donor peripheral blood stem     cell transplant in treating patients with hematologic cancer.   "
166132|NCT00008229|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radioactive drugs such as holmium Ho 166 DOTMP can kill cancer     cells without harming healthy cells. Peripheral stem cell transplantation may be able to     replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill     tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of melphalan with or without     holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients     who have multiple myeloma.   "
166133|NCT00008242|"     RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the     cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from     dividing so they stop growing or die. Combining thalidomide with chemotherapy may kill more     cancer cells.      PURPOSE: Phase II trial to study the effectiveness of thalidomide, doxorubicin, and     dexamethasone in treating patients who have untreated stage II or stage III multiple myeloma.   "
166134|NCT00008255|"     RATIONALE: Doctors can diagnose lung cancer by collecting mucus coughed up from the lungs and     examining it under a microscope to look for cancer cells. Breathing in INS316 may make it     easier for patients to cough up mucus.      PURPOSE: Randomized phase II trial to study the effectiveness of INS316 in helping to     diagnose lung cancer.   "
166135|NCT00008268|"     RATIONALE: Melphalan and colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood.      PURPOSE: Phase II trial to study the effectiveness of melphalan combined with filgrastim in     stimulating peripheral stem cells in patients who have multiple myeloma.   "
166136|NCT00008281|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which regimen of chemotherapy is more effective     for metastatic colorectal cancer.      PURPOSE: Phase III trial to compare the effectiveness of three chemotherapy regimens in     treating patients who have metastatic colorectal cancer.   "
166137|NCT00008294|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Cryosurgery kills cancer cells by freezing them. Combining more     than one chemotherapy drug with cryosurgery and giving drugs in different ways may kill more     tumor cells.      PURPOSE: Phase I trial to study the effectiveness of intrahepatic and intravenous combination     chemotherapy with or without cryosurgery in treating unresectable liver metastases from     colorectal cancer.   "
166138|NCT00008307|"     RATIONALE: Giving chemotherapy drugs, such as fludarabine and melphalan, before a donor bone     marrow transplant or peripheral blood stem cell transplant helps stop the patient's immune     system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal     cells. When the healthy stem cells from a donor are infused into the patient they may help     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by     donor bone marrow transplant or peripheral stem cell transplant works in treating patients     with hematologic cancer or genetic disorders.   "
166139|NCT00008320|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ceramide cream in treating women who     have cutaneous breast cancer.   "
166142|NCT00008359|"     RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or     controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or     peripheral stem cell transplantation. It is not yet known whether caspofungin acetate or     amphotericin B liposomal is more effective for treating these side effects.      PURPOSE: Randomized phase III trial to compare the effectiveness of caspofungin acetate with     that of amphotericin B liposomal in treating patients who have persistent fever and     neutropenia after receiving anticancer therapy.   "
166143|NCT00008372|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of chloroquinoxaline sulfonamide in     treating patients who have small cell lung cancer that has not responded to platinum-based     chemotherapy.   "
166144|NCT00008385|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. It is not yet known if selenium is effective in     preventing the growth of new tumors in patients with previously resected non-small cell lung     cancer.      PURPOSE: This randomized phase III trial is studying selenium to see how well it works     compared to a placebo in preventing the development of second primary lung tumors in patients     who have undergone surgery to remove stage I non-small cell lung cancer.   "
166145|NCT00008398|"     RATIONALE: Sargramostim may lessen symptoms of mucositis in patients receiving radiation     therapy for head and neck cancer. It is not yet known if sargramostim is more effective than     no treatment in reducing mucositis caused by radiation therapy.      PURPOSE: Randomized phase III trial to determine the effectiveness of sargramostim in     decreasing mucositis in patients who are receiving radiation therapy for head and neck     cancer.   "
166146|NCT00008411|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating     patients who have metastatic breast cancer.   "
166147|NCT00008424|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children with     refractory or advanced solid tumors who are receiving anticonvulsants.   "
166148|NCT00008437|"     RATIONALE: Imaging procedures, such as MRI, may allow the doctor to better detect the tumor.     Highly focused ultrasound energy may be able to kill tumor cells by heating the breast tumor     cells without affecting the surrounding tissue.      PURPOSE: Phase II trial to study the effectiveness of MRI-guided ultrasound energy in     treating women who have stage I, stage II, or stage IIIA breast cancer.   "
166149|NCT00008450|"     This pilot clinical trial studies total-body irradiation followed by cyclosporine and     mycophenolate mofetil in treating patients with severe combined immunodeficiency (SCID)     undergoing donor bone marrow transplant. Giving total-body irradiation (TBI) before a donor     bone marrow transplant using stem cells that closely match the patient's stem cells, helps     stop the growth of abnormal cells. It may also stop the patient's immune system from     rejecting the donor's stem cells. The donated stem cells may mix with the patient's immune     cells and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a     donor can also make an immune response against the body's normal cells. Giving cyclosporine     and mycophenolate mofetil after the transplant may stop this from happening.   "
166150|NCT00008463|"     The purpose of this study is to see if treatment with PEG-interferon-alfa-2a (PEG-IFN) plus     ribavirin is a more effective treatment for hepatitis C virus (HCV) than interferon-alfa-2a     (IFN) plus ribavirin for patients infected with both HCV and HIV. The study will also compare     the 2 regimens to see which has fewer side effects.      HCV infection is common in patients infected with HIV. Patients infected with both HIV and     HCV viruses seem to have more severe hepatitis C. A combination of IFN and ribavirin has been     shown to lessen the severity of HCV. PEG-IFN is a modified form of IFN that stays in the     blood longer, which means that patients would not have to take the treatment as often. This     study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with     ribavirin.   "
166151|NCT00008476|"     This study will test the effectiveness of the drug capsaicin in controlling pain after third     molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them     hot, belongs to a class of drugs called vanilloids, which have been found to temporarily     inactivate pain-sensing nerves.      Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom     tooth) extraction may be eligible for this study. Participants will undergo the following     procedures in three visits:      Visit 1:      Patients will have touch (sensory) testing by the following three methods: 1) a warm sensor     applied to the gums and the patient will rate when they first feel heat and when the heat     feels painful; 2) the bristles of a small paint brush will be gently stroked across the gums,     and the patient will say whether it feels painful; 3) a light touch will be applied to the     gums with a small needle, and the patient will rate the pain intensity following the touch.      After testing, patients will be numbed with a local anesthetic (bupivacaine) and then     capsaicin or placebo (an inactive solution) will be injected next to the tooth. The tooth     then will be extracted one day later.      Visit 2:      Patients will return to the clinic after 24 hours to repeat the same type of sensory testing.     After testing, patients will be sedated and numbed with a local anesthetic (lidocaine) and     given an intravenous injection of either saline or ketorolac (30 mg). After the extraction,     pain ratings will be recorded every 20 minutes, for up to 6 hours. During this time, patients     will be monitored for numbness, pain, side effects and vital signs (heart rate, blood     pressure, respiration, etc.). Those who request pain medicine will receive acetaminophen and     codeine. Patients will be required to stay for up to 3 more hours after this and then they     will then be discharged with pain medicine.      Visit 3:      Patients will return to the clinic after another 48 hours to repeat the same sensory testing.     Remaining wisdom teeth will be removed off-study at least three weeks following the first     visit.   "
166152|NCT00008489|"     The purpose of this study is to compare gastrointestinal (stomach and intestines) side     effects of 2 forms of Videx in HIV-infected patients.      Videx can be an effective anti-HIV treatment but many patients will not take the medication     due to its side effects. Videx EC is a capsule form of the drug and may have fewer side     effects. Also, patients would not have to take as many pills since patients taking Videx EC     would have to take only 1 capsule per day instead of 2 tablets per day. This study will see     if patients taking Videx EC have fewer side effects.   "
166176|NCT00005540|"     To study prospectively the interrelationships among physical fitness, activity, other     measured risk factors, coronary heart disease (CHD) and all-cause mortality in a cohort of     3,403 firefighters.   "
166198|NCT00006009|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have advanced or recurrent lymphoma.   "
166153|NCT00008502|"     The purpose of this study is to identify the gene or genes responsible for keloid formation.     Keloids are raised scars on the skin that form after a minor injury. A tendency to develop     keloids often runs in families, suggesting a possible genetic basis.      People who have had a classic (butterfly-shaped or wound-overflowing) keloid for at least one     year may be eligible for this study. In addition to these probands (original participants),     family members over 12 years of age who have either classic or non-classic keloids and those     18 years of age or older without keloids may participate.      Probands and family members with keloids will have a medical history focusing on skin     problems particularly keloids and a skin examination. In some cases, with the subject s     permission, photos of the keloids will be taken. All participants will have 35 milliliters     (about 2 tablespoons) of blood drawn for DNA (genetic) testing and for measurement of blood     proteins, including cytokines, which can affect other tissues and cause scarring. Part of the     blood sample will be used for additional genetic studies unrelated to keloids. The samples     will be coded for confidentiality.   "
166154|NCT00008515|"     This study will test the safety and effectiveness of a fluocinolone implant to treat     age-related macular degeneration. This eye disease can severely impair central vision,     affecting a person's ability to read, drive, and carry out daily activities. It is the     leading cause of vision loss in people over age 60. The fluocinolone implant is a tiny     plastic rod with a pellet of the steroid fluocinolone on the end. The pellet slowly dissolves     and releases the medication into the fluid in the eye.      Vision loss in macular degeneration is caused by the formation of new blood vessels in the     choroid-a thin, pigmented vascular layer of the eye behind the retina. These abnormal vessels     leak blood under the macula, the part of the retina that determines central vision. Tissue     studies show evidence of inflammation in the retinas of patients. This study will test     whether the slow release of the steroid fluocinolone directly into the affected part of the     eye can prevent or slow further vision loss. Preliminary animal and human studies with     fluocinolone implants have shown some benefit in reducing blood vessel growth and improving     or stabilizing vision.      Patients 50 years of age and older with age-related macular degeneration may be eligible for     this study. Study patients will be randomly assigned to one of two treatment groups. One will     receive a 0.5-mg dose implant; the other will receive a 2-mg dose implant. Theoretically, the     implants can release the medicine for 2 to 3 years.      Participants will have a medical history, physical examination and complete eye examination.     The latter will include a vision test, eye pressure measurement, examination of the pupils,     lens, retina, and eye movements. Photographs of the eye will be taken with a special camera.     Patients will also undergo fluorescein angiography, a test that takes pictures of the retina     using a yellow dye called sodium fluorescein. The dye is injected into the blood stream     through a vein. After it reaches the blood vessels of the eye, photographs are taken of the     retina.      When the above tests are completed, patients will be scheduled for surgery to place the     implant. The procedure will be done under either local or general anesthesia. Follow-up     visits will be scheduled 1, 2, 4, and 6 weeks after surgery, then at 3 and 6 months after     surgery, and then every 6 months until the implant is depleted of medicine or is removed.     Several of the exams described above will be repeated during the follow-up period to evaluate     the treatment and side effects, if any.   "
166155|NCT00008528|"     The purpose of this study is to compare the change in viral load (amount of HIV in the blood)     of patients who receive T-20 with selected anti-HIV drugs to that of patients who receive     only selected anti-HIV drugs.   "
166156|NCT00005519|"     To examine associations between various dietary elements and the risk of coronary heart     disease and stroke.   "
166157|NCT00005520|"     To determine whether measured variation in genes coding for components of vasoconstriction     and volume regulating systems predict interindividual differences in blood pressure response     to therapy with a thiazide diuretic, hydrochlorothiazide, or an angiotensin II receptor     blocker, candesartan, in hypertensive African-Americans (N=300 treated with each drug) and in     hypertensive European Americans (N=300 treated with each drug).   "
166158|NCT00005521|"     To use the meta-analytic approach to examine the effects of aerobic exercise on resting     systolic and diastolic blood pressure in children.   "
166159|NCT00005522|"     To examine biopsychosocial processes that might contribute to the associations among social     dominance, gender, and cardiovascular reactivity,.   "
166160|NCT00005523|"     To conduct a randomized trial in asthmatic children to compare the effectiveness of a     home-based allergen control program with a customary educational program delivered in offices   "
166161|NCT00005524|"     To examine the vagal, vascular sympathetic, and mechno-structural components of baroreflex     regulation in coronary artery disease (CAD) patients and healthy age-matched controls during     rest and acute laboratory stress.   "
166162|NCT00005525|"     To conduct a genetic analysis of anatomic risk factors for sleep apnea in a     well-characterized United States population-based registry of elderly male twins who have     been successfully followed for the past 30 years.   "
166163|NCT00005526|"     To identify the genetic (major genes) and environmental factors responsible for the     significant aggregation of abdominal aortic aneurysm (AAA) among relatives of affected     individuals.   "
166164|NCT00005528|"     To evaluate the role of known genes involved in lipid metabolism on serum lipid and     apolipoprotein levels in Samoans residing in American and Western Samoa, who were exposed to     the biobehavioral changes of modernization.   "
166165|NCT00005529|"     To develop and test a self-scored cardiovascular disease health risk appraisal.   "
166166|NCT00005530|"     To elucidate dietary factors that elevate risk for cardiovascular disease (CVD) in     conjunction with insulin resistance.   "
166167|NCT00005531|"     To determine if hereditary susceptibility predisposes African Americans to sarcoidosis and to     identify sarcoidosis susceptibility genes in African Americans.   "
166168|NCT00005532|"     To assess the extent to which consumption of different sources of hydrogenated fat relative     to unhydrogenated oil or butter alters plasma lipoprotein concentrations and measures of     lipid metabolism.   "
166169|NCT00005533|"     To examine the separate and interactive effects of hostility, depressive symptomatology and     socioeconomic status (SES) in predicting coronary heart disease risk.   "
166170|NCT00005534|"     To conduct a population-based study of the prevalence of asymptomatic ventricular     dysfunction.   "
166171|NCT00005535|"     To conduct gene mapping studies for quantitative traits.   "
166172|NCT00005536|"     To identify genes causing hypertensive end-stage renal disease (H-ESRD) in high risk     African-American populations   "
166173|NCT00005537|"     To perform a genome-wide search for genes affecting two phenotypes related to asthma and     chronic obstructive pulmonary disease (COPD) in a Chinese population.   "
166174|NCT00005538|"     To determine the effects of behavioral stress and reproductive hormones on coronary heart     disease (CHD) risk.   "
166175|NCT00005539|"     To investigate the prevalence and incidence rates of cardiovascular disease morbidity and     mortality in people with Type 1 diabetes of long duration.   "
203317|NCT00508963|"     Patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be     treated with sodium stibogluconate (Pentostam).   "
166177|NCT00005541|"     To determine the prevalence, genetic and environmental determinants, and potential clinical,     personal, and societal impact of iron overload and hereditary hemochromatosis, in a     multi-center, multiethnic, primary care-based sample of 100,000 adults. The study is     conducted by the Division of Epidemiology and Clinical Applications of the NHLBI, the     Division of Blood Diseases and Resources of the NHLBI, and the Ethical, Legal, and Social     Implications (ELSI) Research Program of the NHGRI.   "
166178|NCT00005542|"     To identify sarcoidosis susceptibility genes and to determine how these genes and     environmental risk factors interact to cause sarcoidosis.   "
166179|NCT00005543|"     To determine the genetic epidemiology, including genetic and environmental interactions of     the multifactorial disease, venous thromboembolism (VTE).   "
166180|NCT00005544|"     To identify the role of irritant exposure in adult-onset asthma by simultaneously using both     clinical and case control methods in a community-based perspective study of asthma incidence.   "
166181|NCT00005545|"     To determine if risk factors measured in childhood can predict the development of     atherosclerotic coronary and carotid artery disease in adulthood.   "
166182|NCT00005546|"     To identify genes involved in the pathogenesis of three types of congenital heart disease,     atrial septal defects, paramembranous ventricular septal defects, and atrioventricular canal     defects.   "
166183|NCT00005547|"     To investigate the role of chronic infection as a risk factor for vascular disease in a study     of Native Americans. The primary focus is on the two most common agents Chlamydia pneumoniae     and cytomegalovirus with a secondary emphasis on Helicobacter pylori.   "
166184|NCT00005548|"     To examine the prospective association of green tea consumption to the incidence and     mortality of coronary heart disease (CHD) using multivariate analysis while controlling for     the potential confounding effects of cholesterol, triglycerides, glucose and dietary     nutrients.   "
166185|NCT00005549|"     To investigate whether isocyanate-induced asthma is dependent on isocyanate antigen-driven     T-cell mediated, airway inflammation.   "
166186|NCT00005550|"     To evaluate airway inflammation in persons with asthma exposed to endotoxin, a common     occupational air contaminant. Subjects are subsequently challenged with allergen.   "
166187|NCT00005987|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to     give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating     factors such as filgrastim and sargramostim may increase the number of immune cells found in     bone marrow or peripheral blood and may help a person's immune system recover from the side     effects of chemotherapy. Interferon alfa may interfere with the growth of cancer cells. It is     not yet known which treatment regimen is more effective for multiple myeloma.      PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim with that of     sargramostim plus chemotherapy, peripheral stem cell transplantation, and interferon alfa in     treating patients who have multiple myeloma.   "
166188|NCT00005988|"     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the     transplanted cells can make an immune response against the body's normal tissues. Treatment     of the donor bone marrow with the patient's white blood cells and a monoclonal antibody may     prevent this from happening.      PURPOSE: Phase I trial to study the effectiveness of bone marrow transplantation with     specially treated bone marrow in treating patients who have hematologic cancer that has not     responded to previous therapy.   "
166189|NCT00005989|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have     recurrent or metastatic non-small cell lung cancer.   "
166190|NCT00005990|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of R115777 plus topotecan in treating     patients who have advanced solid tumors.   "
166191|NCT00005991|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine and liposomal doxorubicin     in treating women who have metastatic breast cancer.   "
166192|NCT00006003|"     SU5416 may stop the growth of malignant melanoma by stopping blood flow to the tumor. Phase     II trial to study the effectiveness of SU5416 in treating patients who have metastatic     melanoma that has been previously treated   "
166193|NCT00006004|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is more effective for treating non-small     cell lung cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of two combination     chemotherapy regimens in treating patients who have non-small cell lung cancer.   "
166194|NCT00006005|"     RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to     the tumor.      PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who     have recurrent or persistent gynecologic sarcomas.   "
166195|NCT00006006|"     Phase II trial to study the effectiveness of thalidomide plus interferon alfa in treating     patients who have progressive liver cancer that cannot be surgically removed. Thalidomide may     stop the growth of liver cancer by stopping blood flow to the tumor. Interferon alfa may     interfere with the growth of the cancer cells. Combining thalidomide and interferon alfa may     kill more tumor cells.   "
166196|NCT00006007|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in     treating women who have metastatic breast cancer.   "
166197|NCT00006008|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have relapsed or refractory acute lymphoblastic leukemia.   "
166199|NCT00006010|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus docetaxel in treating     patients who have unresectable or metastatic liver cancer.   "
166200|NCT00006011|"     Randomized phase III trial to compare the effectiveness of two combination chemotherapy     regimens plus radiation therapy in treating patients who have stage III or stage IV     endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs     used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining more than one chemotherapy drug with radiation therapy may kill     more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation     therapy is more effective for endometrial cancer.   "
166201|NCT00006012|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     tumor cells. Combining chemotherapy with radiation therapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy before,     during, and after radiation therapy in treating patients who have limited-stage small cell     lung cancer.   "
166202|NCT00006013|"     RATIONALE: SU5416 may stop the growth of multiple myeloma by stopping blood flow to the     cancer cells.      PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have     refractory or relapsed multiple myeloma.   "
166203|NCT00006014|"     Phase II trial to study the effectiveness of SU5416 in treating patients who have malignant     mesothelioma. SU5416 may stop the growth of malignant mesothelioma by stopping blood flow to     the tumor.   "
166204|NCT00006015|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells.      PURPOSE: This phase II trial is studying combination chemotherapy plus trastuzumab to see how     well it works in treating patients with advanced, recurrent, or metastatic colorectal cancer.   "
166205|NCT00006016|"     This phase II trial is studying the effectiveness of combining thalidomide and     chemoembolization in treating patients who have liver cancer that cannot be removed by     surgery. Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor.     Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping     chemotherapy drugs near the tumor. Combining thalidomide with chemoembolization may kill more     tumor cells.   "
166206|NCT00006017|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which regimen of rebeccamycin analogue is more     effective in treating non-small cell lung cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of two rebeccamycin analogue     regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung     cancer.   "
166207|NCT00006018|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of paclitaxel and BMS-214662 in treating     patients who have advanced solid tumors.   "
166208|NCT00006019|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer     cells.      PURPOSE: Phase II trial to study the effectiveness of phenylbutyrate plus azacitidine in     treating patients who have acute myeloid leukemia, myelodysplasia, non-Hodgkin's lymphoma,     multiple myeloma, non-small cell lung cancer, or prostate cancer.   "
166209|NCT00006020|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have     recurrent or refractory acute lymphocytic leukemia.   "
166210|NCT00006021|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by     making cancer cells more sensitive to the drug.      PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C     in treating patients who have recurrent or refractory multiple myeloma.   "
166211|NCT00006022|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill     tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.      PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin     1 in treating patients who have melanoma or kidney cancer that cannot be removed during     surgery.   "
166212|NCT00006023|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who     have metastatic prostate cancer that has not responded to hormone therapy.   "
166213|NCT00006024|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by     radiation therapy in treating patients who have high-grade malignant glioma.   "
166214|NCT00006025|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in     treating patients who have recurrent malignant glioma.   "
166215|NCT00006026|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients     who have metastatic cancer of the urinary tract.   "
167625|NCT00030056|"     This is a study to determine the efficacy and safety of granulocyte-macrophage     colony-stimulating factor (GM-CSF, sargramostim) administered subcutaneously to patients with     pulmonary alveolar proteinosis (PAP).   "
166216|NCT00006027|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor tissue. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known if radiation therapy is more effective with or without combination     chemotherapy for endometrial cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without combination chemotherapy following surgery in treating patients who have stage I or     stage II endometrial cancer.   "
166217|NCT00006028|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating     patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is     recurrent or has not responded to platinum-based chemotherapy.   "
166218|NCT00006029|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating     patients who have relapsed or refractory Hodgkin's lymphoma.   "
166219|NCT00006030|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can     stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast     cancer by blocking the uptake of estrogen by the tumor cells. Combining radiation therapy and     tamoxifen with surgery may kill more tumor cells. It is not yet known which treatment regimen     is most effective for stage I breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of four different treatment     regimens in treating women who have stage I breast cancer.   "
166220|NCT00006031|"     RATIONALE: Biopsy is the removal of cells or tissue for examination under a microscope. It is     not yet known which type of breast biopsy is more effective for diagnosing breast lesions.      PURPOSE: Randomized diagnostic trial to compare the effectiveness of two different types of     biopsy in patients who have breast lesions that cannot be felt upon examination.   "
166221|NCT00006032|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     autologous peripheral stem cell transplantation in treating women who have metastatic breast     cancer.   "
166222|NCT00006033|"     RATIONALE: Inserting the gene for interleukin-2 into head and neck cancer cells may make the     body build an immune response to kill the tumor cells. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. It is not yet     known whether the interleukin-2 gene is more effective than methotrexate for advanced head     and neck cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of the interleukin-2 gene     with that of methotrexate in treating patients who have recurrent or refractory stage III or     stage IV head and neck cancer.   "
166223|NCT00006034|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die. It is not yet known whether keyhole limpet     hemocyanin is more effective than doxorubicin for bladder cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of keyhole limpet hemocyanin     with that of doxorubicin in treating patients who have bladder cancer that has not responded     to BCG or in those patients who cannot tolerate BCG.   "
166224|NCT00006035|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy     drugs to enter tumor cells. Combining chemotherapy with electroporation therapy may kill more     tumor cells.      PURPOSE: Randomized phase I trial to compare the effectiveness of bleomycin with or without     electroporation therapy in treating patients who have stage III or stage IV melanoma.   "
166225|NCT00006036|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor     cells.      PURPOSE: Phase I trial to study the effectiveness of liposomal lurtotecan plus cisplatin in     treating patients who have advanced or metastatic solid tumors.   "
166226|NCT00006037|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. IM-862 may stop the growth of colorectal cancer by stopping blood     flow to the tumor. It is not yet known if chemotherapy is more effective with or without     IM-862 in treating colorectal cancer.      PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy plus IM-862 in     treating patients who have metastatic colorectal cancer.   "
166227|NCT00006038|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     surgery and intraperitoneal chemotherapy in treating patients who have locally advanced     stomach cancer.   "
166228|NCT00006039|"     RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the     growth of non-Hodgkin's lymphoma.      PURPOSE: Phase II trial to study the effectiveness of interferon alfa-2b in treating patients     who have advanced low-grade non-Hodgkin's lymphoma.   "
166229|NCT00006040|"     RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and deliver radiation     to them without harming normal cells. Drugs used in chemotherapy use different ways to stop     cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation     may allow the doctor to give higher doses of radiation and chemotherapy drugs and kill more     cancer cells.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy     plus etoposide followed by peripheral stem cell transplantation in treating patients who have     advanced myelodysplastic syndrome or refractory leukemia.   "
166230|NCT00006041|"     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune     response to kill the tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have ovarian, fallopian tube, or peritoneal cancer.   "
166231|NCT00006042|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Bone marrow transplantation may be able to replace immune cells     that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.      PURPOSE: Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow     transplantation in treating patients who have hematologic cancer.   "
166232|NCT00006043|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who     have metastatic germ cell tumors that have not responded to cisplatin.   "
166233|NCT00006044|"     RATIONALE: High doses of testosterone may be effective in killing prostate cancer cells that     no longer respond to hormone therapy.      PURPOSE: Phase I trial to study the effectiveness of testosterone in treating patients who     have progressive prostate cancer that no longer responds to hormone therapy.   "
166234|NCT00006045|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them     or deliver tumor-killing substances to them without harming normal cells. It is not yet known     if chemotherapy is more effective with or without monoclonal antibody therapy for acute     myelogenous leukemia.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without monoclonal antibody therapy in treating patients who have refractory or     relapsed acute myelogenous leukemia.   "
166235|NCT00006046|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have advanced colorectal cancer.   "
166236|NCT00006047|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of nitrocamptothecin plus etoposide in     treating patients who have advanced solid tumors.   "
166237|NCT00006048|"     RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep     growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs     used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. It is not yet known whether chemotherapy is more effective with or without ZD     1839 for non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without ZD 1839 in treating patients who have stage IIIB or stage IV non-small cell     lung cancer.   "
166238|NCT00006049|"     RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep     growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs     used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. It is not yet known whether combination chemotherapy is more effective with     or without ZD 1839 for non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without ZD 1839 in treating patients who have stage III or stage IV non-small cell     lung cancer.   "
166239|NCT00006050|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving drugs in different ways may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus     leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer     that has spread to the liver.   "
166240|NCT00006051|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation     therapy in treating patients who have head and neck cancer.   "
166241|NCT00006052|"     RATIONALE: STI571 may interfere with the growth of cancer cells and may be effective     treatment for chronic myelogenous leukemia.      PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have     accelerated phase chronic myelogenous leukemia.   "
166242|NCT00006053|"     RATIONALE: STI571 may interfere with the growth of cancer cells and may be effective     treatment for chronic myelogenous leukemia.      PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have     chronic myeloid leukemia that has not responded to interferon alfa.   "
166243|NCT00006054|"     OBJECTIVES: I. Provide curative immunoreconstituting allogeneic bone marrow transplantation     for patients with primary immunodeficiencies.      II. Determine relevant outcomes of this treatment in these patients including quality of     survival, extent of morbidity and mortality from complications of the treatment (e.g., graft     versus host disease, regimen related toxicities, B- cell lymphoproliferative disease), and     completeness of functional immunoreconstitution.   "
166244|NCT00006055|"     OBJECTIVES: I. Determine whether there is prompt engraftment after autologous peripheral     blood stem cell transplantation using filgrastim (G-CSF) mobilization in patients with life     threatening autoimmune diseases.      II. Determine the kinetics of T- and B-cell immune reconstitution after a combination of     timed plasmapheresis, high dose cyclophosphamide and total lymphoid irradiation, and     posttransplant immunosuppression with cyclosporine in these patients.      III. Determine whether this treatment regimen beneficially influences the clinical course of     these patients.   "
166245|NCT00006056|"     OBJECTIVES: I. Determine the efficacy of unrelated donor hematopoietic stem cell     transplantation in the treatment of patients with life threatening hemophagocytic disorders.      II. Determine the rate of disease free survival, incidence of graft failure, and incidence of     graft versus host disease in these patients after undergoing this treatment regimen.   "
166275|NCT00006090|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have chronic lymphocytic leukemia that has relapsed or has not responded to treatment     with fludarabine.   "
166246|NCT00006057|"     OBJECTIVES: I. Determine the phenotypic heterogeneity of patients with genetic disorders     including their clinical spectrum and natural history.      II. Develop and evaluate novel methods for the treatment of genetic disorders including     metabolic manipulation, enzyme manipulation, enzyme replacement, enzyme transplantation, and     gene transfer techniques in these patients.      III. Develop and evaluate methods for the prenatal diagnosis of genetic disorders using     improved cytogenetic, biochemical, and nucleic acid techniques and amniotic fluid cells or     chorionic villi in these patients.   "
166247|NCT00006058|"     OBJECTIVES:      I. Create a clinical sample bank of neonates with lung disease to test hypotheses regarding     the pathogenesis of bronchopulmonary dysplasia (BPD).      II. Determine whether a developmental deficiency of surfactant protein B (SP-B) contributes     to the occurrence of respiratory distress and BPD in these patients.      III. Study metabolic abnormalities associated with inherited deficiency of SP-B in these     patients.      IV. Determine whether plasma nitrotyrosine levels, a marker of peroxynitrite mediated oxidant     stress, are elevated in premature infants who develop BPD.      V. Measure the temporal changes in critical components of the inflammatory process (cell     composition, inducible nitric oxide synthase, hyaluronan (HA), receptor for HA mediated     mobility, and selected cytokines) in bronchoalveolar lavage, blood, and urine samples     obtained from these patients, and to correlate these changes with their clinical course.      VI. Examine changes in the insulin-like growth factor axis that occur in the lungs of infants     with respiratory distress syndrome (RDS) and BPD.      VII. Determine the relationship between degradation of elastin and the clinical course of     BPD.      VIII. Determine whether the normal fall in plasma endothelin-1 concentrations after birth are     delayed in infants with RDS and BPD.   "
166248|NCT00006059|"     OBJECTIVES:      I. Determine the chromosomal regions that contain genes that raise the risk of epilepsy in     families by performing genetic linkage analysis of idiopathic/cryptogenic epilepsy.   "
166249|NCT00006060|"     OBJECTIVES: I. Determine by quantitative magnetic resonance imaging measurements the change     in the total volume of brain parenchyma as well as its gray and white matter, T2 and enhanced     T1 lesion volume, and the magnetization transfer ratio histogram parameters, and correlate     these measurements with clinical measures of disability in patients with multiple sclerosis.      II. Measure the quantity of whole brain N-acetylaspartate in patients with multiple sclerosis     and compare these values to those from age matched controls.      III. Determine the correlation between specific neuropsychological tests which assess global     cognitive functioning and the quantitative measurements taken in these patients in this     study.   "
166250|NCT00006061|"     OBJECTIVES: I. Determine whether plasma choline and breast milk choline levels are low at     fasting in a patient with methionine adenosyltransferase deficiency, and if the choline     levels are low, determine whether choline levels respond to dietary supplementation with     phosphatidylcholine.      II. Determine whether this patient has a fatty liver by magnetic resonance spectroscopy.   "
166251|NCT00006062|"     This is a phase I study of the experimental anticancer drug oxaliplatin. It is designed to     establish the maximum dose of the drug that can be given safely to patients with cancer who     have impaired liver function and to determine the drug's side effects. It will also examine     how liver function affects the drug's elimination from the body. The liver plays an important     role in the elimination of many anticancer drugs, and patients with impaired liver function     should not take certain drugs or should take them in reduced doses.      Patients 18 years of age and older with cancer that has metastasized (spread from the     original tumor site) and for whom standard treatment is not available or is no longer     effective may be eligible for this study. Candidates will be screened with various tests and     procedures that may include physical examination, computerized tomography (CT) or magnetic     resonance imaging (MRI) scans, chest X-rays, and blood and urine tests.      Participants will be given oxaliplatin in doses determined according to their level of liver     function. Patients may have normal liver function or mildly, moderately or severely impaired     liver function, or may have had a liver transplant. Oxaliplatin will be infused intravenously     (through a vein) over two hours on the first day of 21-day treatment cycles-that is, once     every 3 weeks. Treatment will continue as long as the cancer is under control and side     effects do not require stopping the drug. Urine will be collected over 48 hours after the     infusion to determine how much of the drug is eliminated in urine. Blood tests will be done     to monitor safety of the treatment, and imaging studies, such as X-rays, CT and MRI scans,     will be done periodically to evaluate the tumor's response to treatment.      Special blood tests will also be done to study how oxaliplatin is eliminated from the body.     With the first dose of the drug, blood samples will be collected just before the infusion     begins, just before it ends, 15 minutes, 30 minutes, 1, 2, 4, 6, 24, 48, and 72 hours after     the infusion, and again 1 week and 3 weeks later. Additional blood samples may be collected     at the third treatment cycle.   "
166252|NCT00006063|"     OBJECTIVES:      I. Compare the efficacy of enteric coated pancrelipase with bicarbonate (PANCRECARB) capsules     versus the patient's usual enteric coated pancreatic enzyme without bicarbonate in decreasing     fecal fat and nitrogen losses in patients with cystic fibrosis.   "
166253|NCT00006064|"     The purpose of this study is to see how beginning or changing anti-HIV medications affects     the body composition (weight, height, growth, body fat, and muscle mass, or fat and muscle     distribution) of HIV-infected children. This study also looks at how changes in body     composition relate to changes in viral load (level of HIV in the blood), CD4 cell counts,     height, and weight in HIV-infected children. This study also compares changes in body     composition to levels of cytokines (proteins in the body that affect some immune cells) in     HIV-infected children who are beginning or changing anti-HIV therapy.      Though studies have been done on adults, little is known about the effects of HIV infection     and anti-HIV drugs on body composition in children. One theory is that changes in body     composition can predict the failure of anti-HIV treatment. If this is true, body composition     measurements can be as useful as CD4+ cell counts in determining drug effectiveness.   "
166254|NCT00006066|"     The purpose of this study is to determine the safety of a drug called interleukin-2 (IL-2)     given with anti-HIV therapy in children with HIV infection. This study will also determine     the best dose of IL-2 to give children.      IL-2 is an important substance produced by the body's white blood cells that helps the body     fight infection. People with HIV infection do not produce enough IL-2. It is hoped that IL-2     treatment will help boost the immune system in people with HIV infection. It has not been     studied very much in children and doctors need to know what doses are safe to give.   "
166276|NCT00006091|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have chronic phase chronic myelogenous leukemia that has not responded to previous     treatment.   "
166277|NCT00006092|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous     leukemia.   "
166255|NCT00006068|"     Low blood sugar (hypoglycemia) is a recurrent problem for many people with diabetes.     Successful transplantation of clusters (islets) of normal cells, that include those which     produce the sugar-lowering hormone insulin, from the pancreas of a person who did not have     diabetes into a person with diabetes should eliminate high blood sugar levels. We wish to     determine if it will also eliminate low blood sugar. To do so we will give insulin to lower     the blood sugar, measure the levels of the hormones that normally raise blood sugar levels     (e.g., glucagon and epinephrine) and then stop the insulin and see if blood sugar levels     return to normal. Because we anticipate that the transplanted islets will produce insulin,     but not glucagon, this study may also tell us if regulated insulin production alone can     prevent hypoglycemia in humans.   "
166256|NCT00006070|"     This study will evaluate the effects of the anti-inflammatory drug etanercept (Enbrel) on     relieving pain and swelling after oral surgery. The Food and Drug Administration has approved     Enbrel for treating symptoms of rheumatoid arthritis, including pain.      Healthy volunteers 16 to 35 years of age who require third molar (wisdom teeth) extractions     may be eligible for this study. Participants must not be allergic to aspirin or to     non-steroidal anti-inflammatory drugs (NSAIDs). Candidates will be screened for eligibility     with a medical history and oral examination, including X-rays if needed.      Participation in the study requires four clinic visits: two for surgery and two for     follow-up:      Visit 1:      Patients will have ultrasound pictures taken to measure cheek size. One hour before surgery,     they will receive a dose of either 25 milligrams (mg) of Enbrel; 15 mg of the standard pain     medicine Toradol; or a placebo (salt-water) through an arm vein. A local injection of an     anesthetic (lidocaine) will be given before surgery to numb the mouth, and a sedative     (Versed) will be infused through a vein to induce sleepiness. When the anesthetic takes     effect, a small piece of tissue will be removed from the inside of the cheek, and then the     upper and lower molars on one side of the mouth will be extracted. After surgery, a small     piece of tubing will be placed in the lower extraction site, from which samples will be     collected to measure chemicals involved in pain and inflammation. Patients will stay in the     clinic for 4 hours after surgery while the anesthetic wears off and will complete pain     questionnaires during that time. If, an hour after surgery, patients have pain that is not     relieved by the treatment given before surgery, they may receive acetaminophen (Tylenol) and     codeine for pain. Another biopsy will be taken (under local anesthetic) from the inside of     the cheek when pain occurs or at the end of the 4-hour observation period. The tubing then     will be removed and the patient discharged with Tylenol and codeine for pain.      Visit 2:      Patients will return to the clinic in the morning 48 hours after the oral surgery for a 1- to     2-hour visit. They will fill out questionnaires, undergo ultrasound imaging of both cheeks     and have another biopsy taken from the inside of the cheek on the operated side.      Visits 3 and 4:      Three weeks after the first surgery patients will schedule extraction of the two wisdom teeth     on the other side of the mouth, and the procedures for visits 1 and 2 will be repeated.   "
166257|NCT00006071|"     Cells in the lining of blood vessels produce various substances that cause the vessels to     dilate (relax) and constrict (tighten), thereby regulating blood flow. In patients with high     blood pressure and high cholesterol, the blood vessels do not dilate properly. This study     will investigate the effects of rosiglitazone-a drug used to improve the action of insulin in     diabetic patients-on blood flow by examining its effects on endothelin (a substance that     causes vessel constriction), and other substances produced by the vessel-lining cells.      Adults with blood pressure recordings of 140/90 mmHg or higher on at least three separate     days or with a blood cholesterol level of at least 240 mg/dl may be eligible for this study.     Candidates will be screened with a medical history and physical examination, blood pressure     recordings, blood and urine tests.      This crossover study involves two separate treatment periods; that is, participants will     take either rosiglitazone or placebo (an inactive look-alike pill) once a day for 8 weeks,     then no drug for 4 weeks, and then the alternative treatment for the next 8 weeks. Patients     will continue to take their high blood pressure medicines during the first 6 weeks of each     treatment period. They will stop the medication 2 weeks before the following procedures,     which are done at the end of each 8-week treatment period:      Strain gauge plethysmography-A small catheter is placed through a needle into an artery at     the bend of the arm for measuring blood pressure and drawing blood samples during the study.     Pressure cuffs are placed on the wrist and upper arm, and a strain gauge (a rubber band     device) is placed around the forearm to measure forearm blood flow. When the cuffs are     inflated, blood flows into the arm, stretching the strain gauge at a rate proportional to the     flow, and the measurement is recorded.      Small doses of four drugs-acetylcholine, bradykinin, sodium nitroprusside and BQ-123-are     given through the catheter. Acetylcholine slows the heart rate. Bradykinin stimulates the     release of a substance that causes blood vessels to dilate and can lower blood pressure.     Sodium nitroprusside causes blood vessels to dilate and is used to treat high blood pressure     and heart failure. BQ-123 blocks the blood vessel-constricting activity of endothelin.      Brachial ultrasound reactivity study-A baseline ultrasound image (picture produced using     sound waves) of the brachial artery (artery located at the bend of the arm) is taken and     blood flow measurements are recorded. Then, a pressure cuff is placed around the upper     forearm, inflated for 5 minutes to stop blood flow to the forearm, and then released. Images     of the artery and flow measurements are repeated. After a 15-minute rest, new baseline images     are taken and flow measurements obtained. A small amount of nitroglycerin is then sprayed     under the tongue and after 3 minutes, blood flow measurements and brachial artery images are     recorded once more.   "
166258|NCT00006072|"     Peripheral neuropathies cause weakness and sensory loss that can produce severe disability.     Some neuropathies are immune-mediated and associated with antibodies. It has been postulated     that Rituxan treatment may reduce the level of antibody production limiting the loss of     muscle strength and hence improve activities of daily living. The purpose of this open-label     study (all participants get Rituxan and not placebo) is to determine the safety and     effectiveness of Rituxan in the treatment of polyneuropathies associated with serum IgM     autoantibodies in those who have already been treated with one course of Rituxan. Subjects     will be treated on the in-patient Clinical Research Center with Rituxan for two treatments     one week a part and then individual treatments every 10 weeks for one year. The effectiveness     of Rituxan will be followed by looking for increases in muscle strength and decreases in the     serum IgM autoantibodies.   "
166259|NCT00006073|"     This study will evaluate healthy normal volunteers and patients with a variety of endocrine     disorders to 1) learn more about conditions that affect the endocrine glands (glands that     secrete hormones) and 2) train physicians in endocrinology.      Patients with endocrine-related conditions and healthy volunteers of all ages may be eligible     for this study.      All participants will have a physical examination medical and history. They may be required     to provide blood, saliva or urine samples and undergo ultrasound (using sound waves) or     magnetic resonance (using a magnetic field) imaging to visualize internal body structures.      Some healthy adult volunteers will have hormone-stimulating tests to assess endocrine     function. These tests measure blood hormone levels before and after injection of a synthetic     form of a hormone. A device called a heparin lock, through which the hormone is injected and     the blood samples are collected, is placed in a vein in the arm or hand. Blood samples are     drawn before the hormone is injected and at various intervals after the injection to measure     levels of the hormone. These tests, which last from 1 to 3 hours, may include the following:        1. CRH stimulation test corticotropin-releasing hormone is given to test pituitary and          adrenal gland function        2. ACTH stimulation test adrenocorticotrophic hormone is given to test adrenal gland          function        3. LHRH stimulation test luteinizing hormone-releasing hormone is given to test pituitary          gland function        4. TRH stimulation test thyroid-releasing hormone is given to test pituitary and thyroid          gland function        5. GHRH stimulation test growth hormone releasing hormone is given to measure growth          hormone levels.      An oral glucose tolerance test, which is similar to the stimulation tests, may also be done     to measure blood glucose (sugar) and insulin levels after drinking a sugary liquid.      Healthy volunteers and patients with a hereditary endocrine disorder and their family members     may also be asked to provide a blood sample for genetic studies of inherited endocrine     disorders. Patients with endocrine-related disorders may be offered medical or surgical     treatment for their disorder.      AcAccess http://turners.nichd.nih.gov/ for additional study publications.   "
166260|NCT00006075|"     The purpose of this study is to find the best strength of chlorhexidine (a solution that     kills germs), for washing the mother's vagina during labor and the newborn baby, that may     reduce the chance of HIV being passed from an HIV-positive mother to the baby.      When used as a wash on the vagina during labor, and on a newborn shortly after birth, a     higher dose of chlorhexidine is more likely to reduce the rate of HIV-1 transmission from     mother to baby. Laboratory tests suggest that a higher dose of chlorhexidine will be more     effective in killing HIV.   "
166278|NCT00006093|"     RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor.      PURPOSE: Phase I/II trial to study the effectiveness of EMD 121974 in treating patients who     have progressive or recurrent malignant glioma.   "
166261|NCT00006076|"     This study will examine the hereditary basis of tone deafness by identifying regions of the     human genome linked to this condition. Both exceptionally good pitch recognition (perfect     pitch) and exceptionally poor pitch recognition (tone deafness) run in families. A better     understanding of what causes tone deafness may provide new insights into auditory (hearing)     function.      Individuals with two or more family members 15 years of age or older who are tone deaf or     have trouble recognizing different melodies may be eligible for this study. Candidates will     be screened with a short listening test for pitch and a short written test. Those identified     with poor pitch recognition will fill out a brief questionnaire about their family tree and     family members (without identifying names) who have trouble recognizing melodies or tones.     Individuals with poor pitch recognition will be asked to help contact family members who may     be interested in participating.      Members of families with two or more first-degree relatives (parents, grandparents, siblings)     who are tone deaf may enroll in the study. They will provide a blood sample (about 2     tablespoons) for genetic studies and may take a 20-minute hearing test using headphones.   "
166262|NCT00006077|"     This study will evaluate the effects of an experimental drug called NS2330 on Parkinson's     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of     long-term treatment with levodopa. This drug prevents the neurotransmitter dopamine from     entering nerve cells.      Patients between 18 and 75 years old who have moderately advanced Parkinson's disease and     motor problems resulting from levodopa therapy may be eligible for this 5-week study.     Candidates will have a complete medical history and physical examination with a detailed     neurological evaluation. If needed, some patients will undergo a magnetic resonance imaging     (MRI) or computerized tomography (CT) scan of the brain and a chest X-ray. All patients will     have blood and urine tests and an electrocardiogram (EKG) and will take a written test for     evaluation of depression.      Patients enrolled in the study will, if possible, stop taking all antiparkinson medications     except levodopa (Sinemet) for one month before the study begins and through its duration. For     the first 1 to 3 days, patients will undergo a levodopa dose-finding procedure. For this     study, patients will stop taking their usual oral levodopa medicine and instead will have     levodopa infused through a vein for up to 12 hours. During the infusions, the drug dose will     be increased slowly until either 1) parkinsonism symptoms improve, 2) dyskinesias appear, 3)     unacceptable side effects occur, or 4) the maximum study dose is reached.      When the patient's optimal dose is determined, treatment will begin. Patients will take three     pills containing NS2330 or placebo (a look-alike pill with no active ingredient) 3 days a     week for up to 5 weeks, in addition to their regular levodopa medication. All participants     will receive placebo at some point in the study; some patients will receive only placebo     throughout the entire 5 weeks.      On treatment days, patients will have a brief medical examination before receiving the drug     and will then be monitored for side effects for about 6 to 8 hours after taking the drug. At     the beginning of weeks 2 and 5, the levodopa infusions will be repeated at the previously     determined optimum rate. Throughout the study, parkinsonism symptoms, dyskinesias and     depression will be evaluated. Blood and urine samples will be collected each week for     standard safety tests, and blood will also be drawn periodically to measure NS2330 levels.   "
166263|NCT00006078|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. The use of lycopene may be an effective way to prevent prostate     cancer.      PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.   "
166264|NCT00006079|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of eflornithine may be an effective way to     prevent the recurrence of or further development of cervical cancer.      PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in     preventing cervical cancer in patients who have cervical intraepithelial neoplasia.   "
166265|NCT00006080|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who     have recurrent malignant glioma.   "
166266|NCT00006081|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 and paclitaxel     in treating patients who have unresectable locally advanced or metastatic stomach cancer.   "
166267|NCT00006082|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients     who have advanced small cell lung cancer.   "
166268|NCT00006083|"     RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a     catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is     effective in reducing these complications.      PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in     preventing catheter-related complications in cancer patients who are receiving chemotherapy     through a catheter.   "
166269|NCT00006084|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating     patients who have acute myelogenous leukemia that did not respond to standard treatment given     in clinical trial PDL 195-301.   "
166270|NCT00006085|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of CP-609,754 in treating patients who have     advanced solid tumors.   "
166271|NCT00006086|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of BMS-188797 and carboplatin in treating     patients who have advanced nonhematologic cancer.   "
166272|NCT00006087|"     RATIONALE: Diagnostic procedures such as chest x-ray and chest CT scans may be effective in     early detection of lung cancer.      PURPOSE: Randomized clinical trial to compare the effectiveness of a chest CT scan given once     a year with that of a chest x-ray given once a year in detecting lung cancer in patients at a     high-risk of developing lung cancer.   "
166273|NCT00006088|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase I trial to compare the effectiveness of two different regimens of     vinorelbine in treating patients who have metastatic or advanced solid tumors.   "
166274|NCT00006089|"     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Phase II trial to     study the effectiveness of trastuzumab in treating patients who have stage III, stage IV, or     recurrent endometrial cancer.   "
167626|NCT00030069|"     This is a study to determine the response rate in patients with myelodysplastic syndromes     treated with calcitriol and dexamethasone.   "
166279|NCT00006094|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining     chemotherapy, radiation therapy, and surgery may be a more effective treatment for cancer of     the rectum. Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil,     and external-beam radiation therapy followed by surgery in treating patients who have locally     advanced cancer of the rectum   "
166280|NCT00006095|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vincristine plus irinotecan in treating     children who have solid tumors that have not responded to previous therapy.   "
166281|NCT00006096|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known if radiation therapy combined with chemotherapy kills more tumor     cells than radiation therapy alone in treating cancer of the vulva.      PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy with     or without cisplatin in treating patients who have stage I, stage II, or stage III cancer of     the vulva.   "
166282|NCT00006097|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of CC-1088 in treating patients who have     chronic lymphocytic leukemia that has not responded to previous therapy.   "
166283|NCT00006098|"     RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth.      PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have     hematologic cancer.   "
166284|NCT00006099|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Giving monoclonal antibodies     in different ways may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have ovarian cancer.   "
166285|NCT00006100|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Donor white blood cells that are treated in the laboratory with     Epstein-Barr virus may be effective treatment for Hodgkin's lymphoma.      PURPOSE: Phase I trial to study the effectiveness of allogeneic Epstein-Barr virus-specific     cytotoxic T cells in treating patients who have progressive, relapsed, or refractory     Hodgkin's lymphoma.   "
166286|NCT00006101|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. The use of eflornithine may be an effective way to prevent the     development of prostate cancer.      PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in     preventing prostate cancer in patients who are at high risk of developing the disease.   "
166287|NCT00006102|"     Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who     have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to     stop cancer cells from dividing so they stop growing or die.   "
166288|NCT00006103|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if the effectiveness of irinotecan combined     with fluorouracil in treating colorectal cancer varies depending on the patient's racial     background.      PURPOSE: Phase III trial to study the effectiveness of irinotecan combined with fluorouracil     in treating patients from different racial backgrounds who have colorectal cancer that is     advanced, recurrent, metastatic or has not responded to treatment with fluorouracil.   "
166289|NCT00006104|"     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus docetaxel in treating     women who have recurrent or metastatic breast cancer.   "
166290|NCT00006105|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells     from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, cisplatin, and     amifostine following surgery in treating patients who have locally advanced bladder cancer.   "
166291|NCT00006106|"     RATIONALE: A specially modified virus called ONYX-015 may be able to kill tumor cells while     leaving normal cells undamaged. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die. Combining ONYX-015 with chemotherapy may     kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of ONYX-015 combined with cisplatin and     fluorouracil in treating patients who have advanced head and neck cancer.   "
166292|NCT00006107|"     Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating     patients who have stage III or stage IV head and neck cancer.   "
166293|NCT00006108|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel,     and trastuzumab in treating patients who have metastatic breast cancer.   "
166294|NCT00006110|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. Combining chemotherapy, monoclonal antibody therapy, and surgery may be a more     effective treatment for breast cancer.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, monoclonal     antibody therapy, and surgery in treating women who have stage II, stage III, or stage IV     breast cancer.   "
203337|NCT00502775|"     The primary objective of the study is to compare nighttime symptom relief of fluticasone     furoate nasal spray versus oral fexofenadine   "
166295|NCT00006111|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining surgery with chemotherapy and radiation therapy may be an effective way to treat     cancer of the urinary tract.      PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy and     radiation therapy in treating patients who have stage II, stage III, or stage IV cancer of     the urinary tract .   "
166296|NCT00006112|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of fluorouracil with or     without mitomycin in treating patients who have peritoneal cancer.   "
166297|NCT00006113|"     RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to     kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use     different ways to stimulate the immune system and stop cancer cells from growing. Combining     vaccine therapy with biological therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon     gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.   "
166298|NCT00006114|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have metastatic prostate cancer that has not responded to hormone therapy.   "
166299|NCT00006115|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have metastatic colorectal cancer that has not responded to previous     chemotherapy.   "
166300|NCT00006116|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining cisplatin with gemcitabine in     treating patients who have stage IIIB or stage IV non-small cell lung cancer.   "
166301|NCT00006117|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating     patients who have locally advanced or metastatic pancreatic cancer.   "
166302|NCT00006118|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining cisplatin, paclitaxel, and     gemcitabine in treating patients who have progressive unresectable regional or metastatic     bladder cancer.   "
166303|NCT00006119|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients who     have recurrent and/or unresectable meningioma.   "
166304|NCT00006120|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of     docetaxel or paclitaxel in treating women who have unresectable locally advanced or     metastatic breast cancer.   "
166305|NCT00006121|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating women who have     advanced or metastatic breast cancer that has not responded to previous chemotherapy.   "
166306|NCT00006122|"     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.     Drugs used in chemotherapy uses different ways to stop cancer cells from dividing so they     stop growing or die. Combining gemtuzumab ozogamicin with chemotherapy may kill more cancer     cells.      PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin with or without     chemotherapy in treating older patients who have acute myeloid leukemia.   "
166307|NCT00006123|"     RATIONALE: Chemotherapy uses different ways to stop tumor cells from dividing so they stop     growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow     the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal     antibodies such as trastuzumab can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and peripheral stem cell     transplantation followed by trastuzumab in treating women who have metastatic breast cancer.   "
166308|NCT00006124|"     This randomized phase IIb/III trial is studying celecoxib to see how well it works in     preventing disease recurrence in patients who have bladder cancer. Chemoprevention therapy is     the use of certain drugs to try to prevent the development or recurrence of cancer. The use     of celecoxib may be an effective way to prevent the recurrence of bladder cancer   "
166309|NCT00006125|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and topotecan in     treating patients who have relapsed or refractory intermediate-grade or high-grade     non-Hodgkin's lymphoma.   "
166310|NCT00006126|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in     treating patients who have melanoma or small cell lung, breast, testicular, or kidney cancer     that is metastatic or that cannot be treated with surgery.   "
166322|NCT00006138|"     OBJECTIVES:      I. Determine the frequency and severity of osteopenia and osteoporosis in patients with     thalassemia major who undergo dual energy x-ray absorptiometry, and correlate these findings     with other relevant endocrinologic measurements.   "
166311|NCT00006127|"     OBJECTIVES:      I. Evaluate the toxicity of amifostine in patients with bone marrow failure related to     Fanconi's anemia.      II. Determine the efficacy of this treatment regimen in this patient population.      III. Evaluate the effect of this treatment regimen on bone marrow progenitor cell     proliferation and peripheral blood mononuclear cell apoptosis in these patients.   "
166312|NCT00006128|"     OBJECTIVES: I. Determine the relationship of closed head injury (CHI) severity, focal brain     lesions, and the age at injury to the development of working memory, inhibition, and     metacognitive skills in children or adolescents with CHI of varying severity.      II. Assess the development of working memory, inhibition, and metacognitive skills in     relation to discourse functions, scholastic achievement, and adaptive behavior in these     patients.      III. Determine the relationship between impaired inhibition, metacognitive skills, and the     emergence of psychiatric disorder in these patients.   "
166313|NCT00006129|"     OBJECTIVES: I. Determine whether testosterone normalization ameliorates muscle protein     hypercatabolism by increasing net protein synthesis in men with burn injury.      II. Determine whether the effectiveness of testosterone is enhanced by stimulation of inward     amino acid transport as a consequence of hyperaminoacidemia in these men.      III. Determine whether testosterone normalization during hospitalization minimizes the need     for rehabilitation by increasing net protein synthesis and preserving skeletal muscle in     these men.      IV. Determine whether testosterone normalization after hospital discharge and throughout     convalescence increases muscle strength and lean body mass after burn injury by increasing     net protein synthesis.      V. Determine whether testosterone combined with progressive resistance exercise during     convalescence confers added benefits on muscle protein synthesis, and in turn, lean body mass     and muscle strength in these patients.   "
166314|NCT00006130|"     OBJECTIVES: I. Phase II trial to determine surgical morbidity of decompression coring,     including any adverse events in the perioperative period and the rate of secondary medical or     surgical interventions.      II. Collect preliminary data to determine if decompression coring results in a substantial     improvement in pain and mobility compared to conservative therapy in patients with avascular     necrosis of the hip related to sickle cell disease.   "
166315|NCT00006131|"     OBJECTIVES:      I. Compare the efficacy and safety of two doses of oral valacyclovir in immunocompromised     patients with uncomplicated herpes zoster.      II. Compare quality of life, pain, and medical resource utilization in patients treated with     these 2 regimens.   "
166316|NCT00006132|"     OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir in     infants with herpes simplex virus infection involving the central nervous system.      II. Determine whether neurologic outcome is improved in these patients when treated with this     regimen.      III. Determine whether continuous administration of this drug suppresses recurrent skin     lesions in these patients.      IV. Determine the safety of this regimen in these patients.   "
166317|NCT00006133|"     OBJECTIVES: I. Determine the effect of oral contraceptives containing low-dose synthetic     estrogens and progestins on disease activity in premenopausal women with inactive, stable, or     moderate systemic lupus erythematosus (SLE).      II. Determine the effect of hormone replacement therapy with conjugated estrogens and     progestins on disease activity in postmenopausal women with inactive, stable, or moderate     SLE.   "
166318|NCT00006134|"     OBJECTIVES: I. Continue yearly ascertainment visits of all patients of the established Lupus     in Minority Populations: Nature vs Nurture (LUMINA) study cohort.      II. Recruit into the LUMINA cohort newly diagnosed patients with systemic lupus erythematosus     (SLE).      III. Determine the impact of additional major histocompatibility complex (MHC) and non-MHC     genetic factors not previously examined, specifically tumor necrosis factor, mannose binding     protein, interleukin-1 receptor antagonist, and bcl-2, on the course and outcome of SLE.      IV. Refine the assessment of those clinical and behavioral-cultural factors found to be     important predictors of disease activity, damage, and functioning, thus far in these     patients.      V. Determine the relationships among disease activity, disease damage, and physical and     mental functioning in these patients as the SLE progresses and the factors that predict them.   "
166319|NCT00006135|"     OBJECTIVES:      I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants     with herpes simplex virus infection limited to skin, eyes, and mouth.      II. Determine the neurologic outcome in these patients when treated with this regimen.      III. Evaluate the significance of a positive cerebrospinal fluid (CSF) polymerase chain     reaction (PCR) result when all other CSF parameters remain normal in these patients.      IV. Correlate the time to first positive CSF PCR result in the first 12 months of life with     clinical neurological assessment in these patients when treated with this regimen.      V. Determine whether the continuous administration of this drug suppresses recurrent skin     lesions in these patients.      VI. Determine the safety of this regimen in these patients.   "
166320|NCT00006136|"     OBJECTIVES: I. Determine whether arginine butyrate with or without epoetin alfa can stimulate     gamma-globin chain production to a degree that decreases anemia and results in hematologic     improvement in patients with thalassemia intermedia.      II. Determine whether a proportional increase in gamma-globin synthesis and mRNA and an     improvement in nonalfa and alfaglobin chain imbalance by at least 10% over baseline correlate     with improved hematologic response in these patients when treated with this regimen.      III. Determine whether a decrease in hemolysis, as assayed by a decrease in LDH, compared to     baseline levels correlates with improved hematologic response in these patients when treated     with this regimen.      IV. Determine whether any particular genotypes are more responsive than others to this     therapy in these patients.      V. Determine whether baseline epoetin alfa levels, gender, and/or baseline reticulocyte     counts (or percent circulating nucleated erythroblasts) correlate with improved hematologic     response in these patients when treated with this regimen.   "
166321|NCT00006137|"     OBJECTIVES: I. Determine the most sensitive outcome measures (functional or morphological) of     a progressive renal injury in patients with IgA nephropathy.      II. Determine which of these patients are destined to progress to further injury in order to     target them for therapy.      III. Elucidate the determinants of progression in those patients who exhibit evidence of     either increasing impairment of ultrafiltration capacity or ongoing destruction of nephrons.   "
166323|NCT00006142|"     OBJECTIVES:      I. Assess the impact of a phenylalanine restricted diet during pregnancy on symptoms in     offspring of patients with phenylketonuria.   "
166324|NCT00006143|"     The purpose of this study is to determine the effectiveness of recombinant human growth     hormone (r-hGH) on growth in HIV-infected children.      Studies have shown that HIV-infected children do not grow at a normal rate and are shorter     than HIV-uninfected children who are the same age. Growth hormone has been used for many     years to treat children with growth hormone deficiency and has been safe and effective in     helping them to grow normally. The growth hormone to be used in this study, r-hGH, is an     investigational hormone (not yet approved by the Food and Drug Administration [FDA]) made in     the laboratory. It has helped HIV-positive adults gain weight and improve their physical     performance. This study has been changed to include a needle-free device for drug delivery     which will improve patient comfort and acceptability. Patients will no longer receive growth     hormone through traditional needles but through a needle-free device.   "
166325|NCT00006144|"     The purpose of this study is to better understand the relationship between age and HIV     disease progression.      This study will explore the possible relationship between age and HIV disease progression.     Older age is an important risk factor for faster disease development, but older people may     respond better to combination drug therapy. This relationship needs to be understood better.   "
166326|NCT00006145|"     Cytomegalovirus (CMV) infection is a common opportunistic infection (OI) in HIV patients. The     purpose of this study is to find out whether valganciclovir, an antiviral approved by the FDA     for the treatment of CMV in the eye, is safe and effective in preventing CMV organ damage in     people with HIV.   "
166327|NCT00006146|"     It appears likely that there will be a delay and possibly a reduction in the amount of     influenza vaccine available for the 2000-2001 influenza season. One possible way of     increasing the availability of influenza vaccine for this year is to use a half-dose in     healthy adults. The objective of this study is to determine if the immune system responds to     a half-dose the same way it responds to a whole dose. This study will use the currently     approved inactivated influenza vaccine in healthy adults ages 18 to 49 years old.      If the immune response to the half-dose is not significantly different than the immune     response generated to the whole dose, this could be a strategy to extend the amount of     vaccine that could be available in this age group.   "
166328|NCT00006148|"     This study will determine whether the spleen in people who donate stem cells (bone marrow     cells collected from the blood) enlarges as a result of taking granulocyte colony-stimulating     factor (G-CSF). Donors take this growth factor to maximize the amount of stem cells that can     be collected for transplantation to patients with leukemia or other diseases. The study will     also examine whether changes in the donor's white blood cell count, blood stem cell count,     and blood chemistries can predict a change in spleen size.      Stem cells donors take G-CSF for 5 to 6 days before donating. Besides increasing the number     of stem cells and white blood cells in the bloodstream, the drug also causes some other     temporary changes in blood chemistry. Many people who take G-CSF for a few days get a     headache, feel an ache in their bones, or feel tired for a few days. About one-third of     patients chronically treated with G-CSF to raise blood cell counts develop an enlarged     spleen. It is not known if a brief 5- to 6-day course of G-CSF also affects the size of the     spleen, but about 1 in 10,000 blood stem cell donors have had a spontaneous rupture of the     spleen.      Adults and children 18 years of age and older who are donating stem cells for relatives     enrolled in clinical trials at the National Institutes of Health may participate in this     study. They will donate stem cells according to the standard procedure, but will give an     extra 15 milliliters (3 teaspoons) of blood both before receiving G-CSF and after donating     stem cells. Donors' spleen size will be measured by ultrasound scanning of the abdomen three     times: the day before receiving G-CSF, the day after donating the stem cells and 4 days after     donating.   "
166329|NCT00006150|"     The Hyper IgE Syndromes (HIES) are primary immunodeficiencies resulting in eczema and     recurrent skin and lung infections. Autosomal dominant Hyper IgE syndrome (AD-HIES; Job's     syndrome) is caused by STAT3 mutations, and is a multisystem disorder with skeletal,     vascular, and connective tissue manifestations. Understanding how STAT3 mutations cause these     diverse clinical manifestations is critical to our complete understanding of bone metabolism,     bronchiectasis, dental maturation, and atherosclerosis. Mutations in DOCK8 cause many cases     of autosomalrecessive Hyper IgE syndrome. These individuals suffer from extensive viral     infections as well as have a high incidence of malignancy and mortality. The pathogenesis of     this disease is being investigated. Therefore, we seek to enroll patients and families with a     confirmed or suspected diagnosis of HIES syndrome for extensive phenotypic and genotypic     study as well as disease management. Patients will be carefully examined by a     multidisciplinary team and followed longitudinally. Through these studies we hope to better     characterize the clinical presentation of HIES and to be able to identify further genetic     etiologies, as well as understand the pathogenesis of HIES. We seek to enroll 200 patients     and 300 relatives.   "
166330|NCT00006151|"     The purpose of this study is to combine a smoke ending aid with behavioral treatment.   "
166331|NCT00006152|"     The purpose of this study is to see if adding 1 or 2 drugs to the anti-HIV therapy of     patients whose HIV levels increased while taking their anti-HIV drugs can lower viral load     (amount of HIV in the blood) and keep it low up to Week 24. (This study has been changed.     Previously, only patients whose levels increased on their first round of anti-HIV drugs were     being studied.) Anti-HIV drug treatments that contain a combination of 3 or more drugs can     lower HIV levels, raise CD4 cell counts, and improve survival. Unfortunately, many patients     fail their anti-HIV drug treatment when their HIV levels go above 500 copies/ml. Usually     the next step is to switch the patient to different anti-HIV drugs. Doctors would like to see     whether adding 1 or 2 different drugs to the failed treatment also can lower HIV levels.     Adding 1 or 2 drugs might be better than switching all of the drugs since patients who take     many different drugs can develop drug-resistant HIV. (This study has been changed.     Previously, only patients taking protease inhibitors (PI) whose levels increased on their     first round of anti-HIV drugs were being studied.)   "
166379|NCT00006204|"     This study will examine the effects of combing naltrexone and fluoxetine (Prozac) versus     fluoxetine and placebo in alcoholics with co-occurring major depression. Both groups will     actively participate in the 6-month study, which includes weekly individual Dual Disorders     Recovery Counseling during the first month and every two weeks during the second through     sixth months, plus the naltrexone and fluoxetine or fluoxetine and placebo. Subjects will     complete follow-up assessments at 9 and 12 months.   "
166332|NCT00006153|"     The purpose of this study is to see if giving a vaccine (Remune) is effective in HIV-positive     patients who are also taking anti-HIV therapy.      Regular treatment of HIV-positive patients with anti-HIV drugs slows the multiplication of     the HIV virus in the body. A vaccine called Remune works to stop the virus infection by     boosting the body's immune cell defense against the HIV virus before the virus enters     cells. It also blocks the virus from entering the cells. This study will see whether Remune     will improve the immune cell natural defense in patients who are also taking anti-HIV drugs.   "
166333|NCT00006154|"     The purpose of this study is to look at the effectiveness of combination anti-HIV drug     therapy (with protease inhibitors [PIs] or without) in patients with early HIV infections.     This study also looks at whether a drug called interleukin-2 (IL-2) can boost the immune     system of these patients.      Doctors are not sure which anti-HIV drug combination is best to use in patients who have     early HIV infection and have never received anti-HIV treatment. PIs are anti-HIV drugs that     decrease viral load (level of HIV in the blood). However, PIs can cause serious side effects     in some patients. Doctors would like to know if a drug combination that does not contain a PI     is just as good as one that contains PIs.   "
166334|NCT00006155|"     SU5416, a novel antiangiogenesis agent, has been shown to be a potent and selective inhibitor     of the tyrosine kinase activity of FlK-1 (a downstream effector of VEGF) in vitro and to     inhibit the growth of endothelial cells. Since VEGF mRNA levels and vessel counts in tumor     tissues have been shown to be inversely related to prognosis in ovarian cancer, SU5416 may     prove to be a useful agent in this disease. Platinum agents currently provide the most     effective treatment for ovarian cancer. However, ovarian cancer often becomes refractory to     platinum therapy, leaving the patient with a poor prognosis. This is a phase I study designed     to: a) determine a dose level of carboplatin to use in combination with an established dose     of SU5416 for treatment of patients with platinum-refractory ovarian cancer, b) assess the     side effect profile of SU5416 and carboplatin combination therapy, c) characterize any     alterations in SU5416 pharmacokinetic and pharmacodynamic parameters when given in     combination with carboplatin, d) characterize carboplatin pharmacokinetic and pharmacodynamic     parameters when given in combination with SU5416, e) do exploratory studies to assess the     effect of SU5416 on platinum-DNA adduct levels, f) do exploratory studies to assess any     alterations in ERCC1 mRNA levels when carboplatin is administered with SU5416, and g) obtain     preliminary evidence of the ability of SU5416 to reverse platinum resistance in patients with     platinum-refractory ovarian carcinoma.   "
166335|NCT00006156|"     This purpose of this study is to gain information about normal ovarian function that will be     useful in developing a test for early detection of ovarian failure. The ovaries produce     female hormones, such as estrogen, that are important in maintaining a woman's health. When     the ovaries do not work properly, problems can develop. Unfortunately, there is no test that     can detect ovarian failure early in its course. By the time premature ovarian failure is     diagnosed in young women, two-thirds have already developed osteopenia (loss of some bone     mass) and nearly one in ten have osteoporosis, a greater loss of bone mineral density that     weakens bones and increases the risk of fractures.      Women with normal ovarian function ages 18 to 55 and postmenopausal women 60 years of age or     older may be eligible for this study. Candidates will be screened with a medical history,     physical examination, blood tests and vaginal ultrasound examination. For the ultrasound     study, a probe that emits sound waves is inserted into the vagina, and the sound waves are     converted to form images of the ovaries. The procedure is done with an empty bladder and     takes about 10 minutes. After this screening visit (Visit 1), those enrolled in the study     will return to the NIH Clinical Center for the following additional procedures:      Visit 2-Will be scheduled between days 3 and 5 of the menstrual cycle (for women who are     still menstruating). Participants will have blood tests to measure hormone levels and to     check for pregnancy, and will have another transvaginal ultrasound examination. They will     then receive an injection of a synthetic form of follicle stimulating hormone (FSH), a     hormone the body makes normally.      Visits 3 and 4-Will be scheduled 24 and 36 hours after the FSH injection given during Visit 2     for collection of blood samples.      Visit 5-Will be scheduled 48 hours after the FSH injection for additional blood sampling and     a final transvaginal ultrasound examination.   "
166336|NCT00006157|"     The primary purpose for this study is to compare clinical treatments for patients with     functional bowel disorders (irritable bowel syndrome, abdominal pain, painful constipation)     in women. We also plan to: 1) determine what clinical features (medical or psychological)     determine which patients will improve to these treatments, and 2) understand if there are any     physiological features that relate to improvement in symptoms and response to the treatments.      We will compare a psychological treatment (cognitive-behavioral therapy - CBT) with     education/attention placebo, and an antidepressant drug (desipramine) with a pill placebo.     This is the first large-scale study designed to determine the therapeutic effects of these     methods, and to also determine interactions among physiologic measures, psychologic and     sociodemographic factors, severity of symptoms, and therapeutic improvement including quality     of life.   "
166337|NCT00006158|"     The study is a 6 month, placebo-controlled study of transdermal testosterone for women with     HIV-associated weight loss. Women with AIDS wasting have been found to have low testosterone     levels. This study is designed to test the efficacy of physiologic testosterone dosing to     improve weight, muscle mass and quality of life indices, including energy level, appetite and     libido, in androgen deficient women with AIDS wasting. After 6 months, all women receive open     label transdermal testosterone for an additional 6 months.   "
166338|NCT00006159|"     The purpose of this project is to determine whether a diabetes lifestyle program will improve     the lives of Native American people living with diabetes. We recruited Native American people     living in 8 Pueblo communities served by 3 Indian Health Service clinics. Forty percent of     people living with diabetes in those communities participated in an interview and had height,     weight, blood pressure and hemoglobin A1c measured at the beginning. Then they received a     lifestyle program in either groups or one-on-one, or another group which got the intervention     after one year (comparison group). The program was developed using input from community     members, tribal leaders, and clinic staff, and was taught by community members in or near the     participating communities. After each session, participants were asked for feedback about the     curriculum. After the program ended, the interview and clinical measures were repeated.     Feedback to tribal leaders and clinical staff is ongoing.   "
166339|NCT00006160|"     A controlled trial to assess the potential benefit of a home based worker in improving     control in African-American children with insulin dependent diabetes.   "
166380|NCT00006205|"     The purpose of this study is to learn whether ondansetron and topiramate either alone or in     combination is safe and effective in the treatment of alcohol dependence. This 13 week     out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are     post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will     receive ondansetron and topiramate either alone or in combination or a placebo coupled with     psychotherapy.   "
166340|NCT00006161|"     The Decompression Intervention of Variceal Rebleeding Trial (DIVERT) is a multi-center     prospective randomized clinical trial comparing the radiologic procedure of transjugular     intrahepatic portal-systemic shunt (TIPS) with the surgical procedure of distal splenorenal     shunt (DSRS) for variceal bleeding in patients with Child's Class A and B cirrhosis.      This is recognized nationally and internationally as the study that will answer the question     as to which of these is the best treatment for decompression of varices in patients who have     failed endoscopic and pharmacologic therapy.   "
166341|NCT00006162|"     Type 2 diabetes is more frequent in Japanese Americans than in Japan or the U.S. non-Hispanic     white population. This appears to be due to the effects of ''westernization'' to bring out     metabolic changes that lead to diabetes. This study will look at whether increased physical     activity and dietary changes will reduce or prevent the metabolic changes that lead to type 2     diabetes in Japanese Americans who have impaired glucose tolerance, a condition intermediate     between normal glucose tolerance and diabetes.   "
166342|NCT00006163|"     This project evaluates the effectiveness of different aspects of a program to assist type 2     diabetes patients with dietary changes. It evaluates the effectiveness of Personalized     Self-Management Training and Community Resources support, using a randomized design. This     study will also evaluate what percent of patients are willing to participate in such a     program, and what percent of primary care physicians are willing to recommend it to their     patients.   "
166343|NCT00006164|"     The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases     sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated     interferon) in patients who failed to respond to prior interferon treatment. All patients who     enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin.     Patients who respond to this 6 month treatment will continue to be treated for an additional     6 months.      Patients who do not respond to this treatment will be eligible for the long-term maintenance     phase of this study where patients will be randomly selected to be treated with Peginterferon     alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will     be followed closely with quarterly study visits.      The combination of peginterferon plus ribavirin has recently been approved by the FDA for     treatment of chronic HCV. Patients who remain HCV-RNA positive after being treated for at     least 6 months with peginterferon and ribavirin outside of this study may be eligible to     directly enter the randomized portion of the HALT-C Trial.      The HALT-C study is designed to determine if continuing interferon long-term over several     years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer     and reduce the need for liver transplantation.   "
166344|NCT00006165|"     The Native Hawaiian Diabetes Intervention Program is a project focused on determining whether     a cultural-based, healthy lifestyles program with family support will have a positive effect     on lifestyle behaviors and psychosocial and clinical outcomes. A culturally sensitive,     lifestyle intervention program was administered via community peer educators to a population     of Native Hawaiians with or at risk for diabetes. The effect of this intervention program on     selected outcomes is being compared to a ''standard'' program given to a similar population     in a second Native Hawaiian community.   "
166345|NCT00006166|"     The NASTRA Clinical Trial is a multi-center, randomized, controlled clinical trial designed     to determine if treatment with transjugular intrahepatic portasystemic shunts (TIPS) is     superior to high volume paracentesis (total paracentesis, TP) for the treatment of refractory     ascites due to cirrhosis. Only patients with clinically tense symptomatic ascites (shortness     of breath, umbilical hernia, abdominal pain and/or distension, and/or limitation of activity)     who have either diuretic-resistant ascites or diuretic-intractable ascites are being studied.   "
166346|NCT00006167|"     There are no guidelines for appropriate nutritional management of weight loss or wasting in     HIV infection. Some treatments may increase weight, but without improving muscle mass or     quality of life. In this clinical trial AIDS patients with wasting are randomized to one of     three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition     with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral     nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition     with progressive resistance training (PRT). In all participants, dietary intervention is     maximized by weekly personalized counseling to address individual issues and concerns. Two     primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be     used to develop guidelines for standards of nutritional care among AIDS patient with the     wasting syndrome.   "
166347|NCT00006168|"     The major thrust is to determine whether treatment of patients with Primary Biliary Cirrhosis     (PBC) with Ursodiol (Ursodeoxycholic Acid-UDCA) plus methotrexate (MTX) is more effective     than treatment with UDCA alone.   "
166348|NCT00006169|"     The current study examines the efficacy of two treatments to help children with cystic     fibrosis (CF) meet their dietary calorie requirements of 120% to 150% of the recommended     daily allowance of energy and the effect of these treatments on weight gain and maintenance.     One treatment provides children with CF and their parents nutrition education about the best     foods for meeting their dietary needs. The second treatment gives children with CF and their     families similar nutritional information plus behavioral parenting methods for motivating     children to eat the recommended foods. Children with CF and their families are seen weekly     for 7 treatment sessions across 9 weeks for the active phase of treatment. Families are then     followed for 2 years after treatment in order to better understand how long the treatments     are effective and to determine the health benefits of better nutrition status and weight     gain.   "
166349|NCT00006170|"     The purpose of this study is to determine whether the addition of bupropion (Zyban) to     cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.   "
166381|NCT00006206|"     Combine is a multicenter, randomized clinical trial that will evaluate combinations of three     interventions for treating alcohol dependence. The goal is to determine whether improvement     in treatment outcomes can be achieved by various combinations of drug and behavioral     interventions. Two of the interventions will consist of pharmacological treatment with     naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent     behavioral therapy including such components as motivational enhancement therapy, cognitive     behavioral therapy, and referral to self-help groups, including AA. All three interventions     will include a component supporting compliance to medications and reduction in drinking.   "
166350|NCT00006171|"     Background:      Kaposi s sarcoma (KS) is caused by a gammaherpesvirus called Kaposi s sarcoma-associated     herpesvirus (KSHV), or human herpesvirus-8 (HHV-8). However, infection with KSHV is not     sufficient to cause KS, and HIV infection is an important cofactor. Treatment of HIV with     potent antiretroviral therapy can reduce the risk of KS, and can also induce regression in     patients with established HIV-KS. One mechanism by which HIV is believed to contribute to KS     is through HIV-induced immunodeficiency which leads to a loss of immunologic control of KSHV     and/or KS itself. However, other mechanisms may also contribute.      Objectives:      One primary objective is to assess the effects of the initiation of potent anti-HIV therapy     on specific factors possibly linked to the control or pathogenesis of KS, namely serum viral     IL-6 and plasma VEGF levels, in patients with KS or at risk for KS by virtue of being     infected with KSHV/HHV-8. Another is to assess the effects of anti-HIV therapy on KSHV     infection. Secondary objectives are to assess the effects of potent antiretroviral therapy on     established KS and other factors related to KS or KSHV infection.      Eligibility:      The principal eligibility factors are age 13 or above, HIV infection, and either KS or     infection with KSHV. Exclusion factors include KS that requires specific therapy, recent     corticosteroid therapy, recent cytokine therapy, or opportunistic infections requiring     therapy.      Design:      Patients will be treated with potent antiretroviral therapy. For patients with established     KS, the effects of the therapy on the KS will be monitored. In addition, a variety of factors     related to KS, HIV infection, therapy, or KSHV infection will be monitored. These include the     HIV viral load, KSHV secretion in saliva, the CD4 count, serum VEGF levels, and serum IL-6     levels.   "
166351|NCT00006172|"     This study investigates the potential efficacy of two nonpharmacologic treatments for     nonseasonal depression, bright light exposure or high-density negative air ion exposure.     Treatments are self-administered at home by the patient under close clinical supervision.   "
166352|NCT00006173|"     Renovascular hypertension (RVH) is a potentially curable disease affecting 0.5-5 percent of     patients with hypertension. The current diagnostic work-up of RVH involves a complex     algorithm which includes doppler ultrasound, captopril renography and conventional     angiography. Because of the expense, risk and inconvenience of this workup, patients may not     be correctly diagnosed.      Advances in MR technology present the opportunity to develop a single comprehensive test.     This would combine an MR angiogram that provides anatomic information about the renal     arteries, and an MR renogram that provides information about the functional impact of a     stenosis as a cause of hypertension. Our main purpose is to test MR renography with and     without an oral angiotensin converting enzyme inhibitor (ACEI) combined with MR angiography     against the reference standard of captopril radionuclide renography. Secondary goals of this     study are to test whether hypoxia within ischemic kidneys affected by RVH is detectable by T2     weighted (Blood oxygen level dependent or BOLD) MRI. This is considered of value since such a     test of oxygenation would further shorten and simplify the diagnostic MR test. Information     gained from this study could lead to important changes in the diagnostic and pathophysiologic     understanding of RVH.   "
166353|NCT00006174|"     This study will test the safety and effectiveness of letrozole in treating precocious (early)     puberty in girls with McCune-Albright syndrome (MAS). The physical changes of puberty, such     as breast enlargement, menstruation and growth spurt, as well as the emotional changes of     this developmental stage, usually begin in girls between the ages of 8 and 14. Girls with     MAS, however, often begin puberty before age 7. In MAS, large ovarian cysts produce high     levels of estrogens (female hormones) that cause the changes of puberty. Children with MAS     also have polyostotic fibrous dysplasia (PFD), a disease of bones that, depending on what     parts of the skeleton are affected, can lead to broken bones or disfigurement of the head,     face, arms and legs, or can cause pressure on nerves and blood vessels. Many children with     MAS have cafe-au-lait spots (increased pigmentation) on areas of their skin as well.      Letrozole is an estrogen-lowering drug that has been approved for treating women with breast     and other cancers. Although the drug has not been tested or approved for use in children,     some pediatric specialists have given it to girls with precocious puberty and MAS and found     that it improves their condition without harmful side effects. This study will examine     whether letrozole can lower estrogen in girls with MAS and arrest puberty. It will also study     the drug's effects on substances involved in bone growth, including calcium, phosphate and     amino acids.      Girls 1 to 8 years old with MAS may be eligible for this study. Patients who were enrolled in     NIH protocol 98-D-0145 (Screening and Natural History of Patients with Polyostotic Fibrous     Dysplasia and the McCune-Albright syndrome) are also eligible. Participants will be admitted     to the hospital for 2 to 3 days every 3 months for 15 months, for a total of 6 visits. They     will undergo a complete history and physical examination and routine blood and urine tests     every visit, as well as evaluations of their general health, growth and bone development,     endocrine system (hormone-secreting glands) status and PFD status. A hand X-ray will be taken     at the first visit and every 6 months to measure bone age advance. The children will begin     taking letrozole at the second visit and continue the drug for 6 months. They will be     evaluated after 3 months and 6 months on the drug (visits 3 and 4), and again after 3 months     and 6 months after stopping treatment (visits 5 and 6).      Parents of children who weigh more than 18 kilograms (about 40 pounds) may be asked if extra     blood may be drawn after 3 months (visit 3) and 6 months (visit 4) of treatment to measure     letrozole levels. The blood will be drawn before the morning dose and at 0.5, 1, 1.5, 2, 3,     4, 6, 8, and 24 hours after the dose through an indwelling needle placed in the vein for 8 to     24 hours.      Parents will keep a record of all episodes of menstrual bleeding and any other symptoms or     complaints. Children who respond well to therapy (decreased menses, slowed breast     development, slowed growth and bone age advance) will be offered another 12 months of     letrozole treatment.   "
166354|NCT00006175|"     This study will measure levels of an enzyme called cyclooxygenase in gum tissue following     third molar (wisdom tooth) extraction. Cyclooxygenase is thought to contribute to pain that     normally follows tissue injury or surgery.      Healthy volunteers between 16 and 35 years of age who require removal of their third molars     may be eligible for this study. Participants will receive an injection of a local anesthetic     (lidocaine) in the mouth and a sedative (midazolam) through an arm vein before surgery.     Before the tooth is removed, a small tissue sample (biopsy) will be collected from the gum     tissue covering one of the lower third molars to be extracted. After surgery, a second biopsy     will be taken at some point between just after surgery to the time when pain from the     extraction starts to develop. These tissue samples will be analyzed for cyclooxygenase     levels.      Patients will stay in the clinic for up to 4 hours after surgery while the anesthetic wears     off. During this time, they will complete pain questionnaires. If needed, patients may     receive additional medicine for pain relief at any time during the surgery or the 4-hour     observation period. They will also be given standard pain medication to take home at the end     of the study.   "
166355|NCT00006176|"     The purpose of this study is to learn more about the medical problems and the genetic factors     involved in a recently defined form of inherited dementia called familial dementia with     neuroserpin inclusion bodies (FDNIB). Abnormal substances in nerve cells of patients with     this disease affect brain and nervous system function, causing confusion, memory decline and     impaired cognition (thinking ability). Patients also develop movement disorders and,     possibly, seizures. Symptoms begin in midlife, between 45 and 55 years of age.      Patients with FDNIB and family members 18 years of age or older at risk for the disease may     be eligible for this 3-year study.      Participants will have a medical and family history and review of medical records; interview     with a medical geneticist (specialist in genetics); physical, neurological and psychiatric     examinations; and the following tests and procedures:        1. Blood tests to assess general health        2. Chest and skull X-rays        3. Electrocardiogram (EKG)-record of the electrical activity of the heart using electrodes          placed on the chest        4. Electroencephalogram (EEG)-record of the electrical activity of the brain using          electrodes placed on the head        5. Ultrasound of the abdomen-imaging of abdominal organs using sound waves        6. Brain magnetic resonance imaging (MRI)-imaging of the brain using a strong magnetic          field and radio waves        7. Hearing evaluation        8. Assessment of performance of daily living activities        9. Single photon emission computed tomography (SPECT)-imaging of brain metabolism and blood          flow using a radioactive substance injected into a vein      The evaluation will be done over a 3- to 4-day period. At their completion, participants will     meet with a physician and a genetics counselor to discuss the clinically significant     findings. Participants may be asked to return for follow-up evaluations every 6 months to a     year (depending on the individual's condition) for 3 years.   "
166363|NCT00006185|"     With the advent of highly active anti-retroviral therapy(HAART), patients with HIV disease     are developing a series of metabolic abnormalities including peripheral fat wasting, increase     in truncal fat, high serum triglyceride levels, insulin(a hormone that controls blood sugar)     resistance with an increased incidence of Type 2 Diabetes Mellitus and elevated blood     pressure. The premise of this study is that abnormalities in the ability of fat and muscle     tissue to respond to the hormone insulin may be the cause of the diabetes mellitus, high     serum triglyceride levels and abnormal fat distribution. The purpose of the study is to     assess how insulin resistant patients with HIV disease are and if their fat and muscle tissue     are responding abnormally to insulin. This is done by administering insulin and taking small     tissue samples of fat and muscle from the upper thigh and assessing how good insulin acts in     these tissues.      Patients with HIV disease will be admitted into the study after undergoing a screening     medical history and examination. Once patients qualify, they will have their insulin     resistance measured as well as the response of their fat and muscle to insulin; blood levels     of glucose (sugar), cholesterol and triglycerides will be measured; body fat will be assessed     using radiological tests; a detailed medical history will be obtained to assess risk factors     for developing this syndrome.      Patients who are found to be insulin resistant will be offered a trial of an insulin     sensitizing agent, called Avandia, for 6-12 weeks. It is hoped that the Avandia will restore     the body's ability to respond normally to insulin (as it does in patients with Diabetes) and     perhaps improve the fat abnormalities as well. All the same measures will be performed at the     end of the course of Avandia as were done at baseline.      Patients who are not insulin resistant will be asked to come back yearly to assess whether     they develop insulin resistance over time. This study will continue to recruit patients over     the next 3 years.   "
166394|NCT00008853|"     The purpose of this study is to test the safety and favorable immune response to an     anti-streptococcal vaccine (a vaccine that treats a common bacterial infection) in healthy     non-pregnant women.      Group B Streptococcus (GBS) continues to be the single most frequent cause of     life-threatening bacterial infection during the first 2 months of life. Further, GBS     pregnancy-related morbidity afflicts more than 50,000 women annually in the US. Therefore,     active immunization of women is an appealing strategy for the prevention of GBS disease in     pregnant women and their infants during the first 3 months of infant life.   "
166357|NCT00006178|"     This study will test the safety and effectiveness of two drugs, Sirolimus and Thymoglobulin,     for preventing rejection of transplanted kidneys. Standard anti-rejection therapy uses a     combination of drugs, such as cyclosporine, tacrolimus, azathioprine, steroids, and others,     that are taken daily for life. However, even with this daily therapy, more than half of     kidney recipients slowly reject their transplant within 10 years. Both Thymoglobulin, an     antibody, and Sirolimus, an anti-rejection drug, prevent rejection by lowering the response     of the immune system to the transplanted organ. Thymoglobulin is given in the pre- and     postoperative period, and Sirolimus is taken long term.      Patients who receive a kidney transplant at the National Institutes of Health Clinical Center     are eligible for this study. Candidates will be screened with a medical history, physical     examination, and blood and urine tests.      Participants will undergo a kidney transplant. Before the surgery, a central line     (intravenous catheter), through which blood and medicine can be given, is placed in the neck     or chest. Patients may also undergo leukapheresis, a procedure for collecting white blood     cells. The cells can be stored for transfusion later if white cell counts drop following     Thymoglobulin treatment. For this procedure, blood is drawn from a needle placed in the arm     and flows into a machine that separates the blood components by spinning. The white cells are     collected in a bag and the red cells and plasma are returned through a second needle in the     other arm.      Thymoglobulin will be given intravenously the day before the transplant and days 1 through 9     after the operation. Sirolimus will be taken by mouth, mixed with water or orange juice.     Sirolimus therapy starts the day of the transplant and continues for life.      Follow-up study visits will be scheduled weekly for the first month after the transplant,     then every 6 months for 1 year and then once a year for 4 years. Procedures during these     visits may include blood and urine tests, physical examination, and check of vital signs     (i.e., blood pressure, heart rate, breathing rate, temperature). Kidney biopsies (removal of     a small piece of tissue for examination under the microscope) will be done at 2 weeks, 1     month and 6 months after surgery and then yearly for 4 years to check for any damage to the     kidney. In addition, a local doctor will do routine laboratory tests 2 to 3 times a week for     the first 2 to 3 months aft...   "
166358|NCT00006180|"     The purpose of this study is to determine whether women with major depression lose bone mass     at a faster rate than women without depression. This study will also determine if the drug     alendronate can maintain or increase bone mass in premenopausal women with major depression     and osteoporosis.      Depression may be a major risk factor for osteoporosis; it is associated with abnormally     elevated stress hormone levels that may contribute to bone loss. This study will evaluate     bone mass in women with depression and healthy volunteers.      Participants will undergo psychiatric, medical, dietary, and stress hormone evaluations and     bone mineral density (BMD) measurements.      Participants with depression will be divided into two groups: those with normal BMD and those     with low BMD. Depressed participants with normal BMD will be compared to a control group of     healthy premenopausal women with normal BMD and followed for 36 months. Dual energy X-ray     absorptiometry (DEXA) determinations will be made at months 6, 12, 24 and 36; bone turnover     and endocrine parameters of depression will be      measured every 3 to 6 months.      Participants with depression and low BMD will be randomly assigned to receive either     alendronate or placebo (an inactive pill) once a week for 24 months. Participants will     receive calcium and vitamin D supplements daily. DEXA determinations will be performed at     screening, and at Months 6, 12, 18 and 24; bone turnover and endocrine parameters of     depression will be measured every 3 to 6 months.      For both groups, up to four of the visits may optimally be done as inpatient stays of two     nights. All remaining visits are as outpatients.   "
166359|NCT00006181|"     Promoting Healthy Lifestyles: Alternative Models' Effects (PHLAME) is a research study to     evaluate and compare two ways to promote healthy behaviors, (regular physical activity, less     than 30% calories from fat, 5 or more servings of fruits plus vegetables each day and     maintain a healthy weight). Unhealthy nutrition practices and sedentary (inactive) lifestyles     are the two most common harmful behaviors in the United States. Our two health promotion     methods are 1) a team-based approach and 2) a one-on-one approach involving meetings with a     health counselor. A third group only receives the same evaluation and their results and is     the control group. Study participants are firefighters from 36 fire stations in Oregon and     Washington.      The goals of the study are increased physical activity and fitness, improved nutrition, and     improved energy balance (reduced body fat). Changes in these factors can help lower risks for     heart disease, some types of cancer, diabetes, hypertension and musculoskeletal injuries.     Results from PHLAME will provide information on how best to help adults achieve and maintain     healthy lifestyles.   "
166360|NCT00006182|"     To determine how long blood transfusions are needed for primary stroke prevention. Also, to     determine the duration of risk associated with abnormal transcranial Doppler ultrasound (TCD)     and to determine the specificity of the stroke risk model developed in STOP 1 in patients     with abnormal TCD measurements.   "
166361|NCT00006183|"     The purpose of this study is to compare the effects of diluted hematocrit (HCT) levels of 35%     versus 25% during hypothermic cardiopulmonary bypass (CPB) in infants with d-transposition of     the great arteries, a malformation of the heart vessels.   "
166362|NCT00006184|"     Background:      The mainstay of therapy for newly diagnosed multiple myeloma patients remains systemic     chemotherapy. Although partial remissions of up to 60% are obtained with conventional     regimens, multiple myeloma is essentially an incurable disease with a median survival of     approximately 30 months.      Allogeneic stem cell transplantation (SCT) results in a high percentage of complete     remissions, but it can be associated with significant treatment-related mortality, which has     been primarily attributed to conventional myeloablative transplant regimens.      Recent clinical studies have shown that highly immunosuppressive yet non-myeloablative doses     of fludarabine-based chemotherapy can result in alloengraftment. Even with a reduction in     treatment related mortality, success with allogeneic SCT is limited by a significant risk of     relapse.      Donor immunization with myeloma Id in the setting of a non-myeloablative allogeneic SCT may     represent a novel strategy for the treatment of multiple myeloma.      Objectives:      Primary Objectives:      To induce cellular and humoral immunity in allogeneic stem cell donors and recipients against     the unique idiotype expressed by the recipient's myeloma.      To determine whether antigen-specific immunity, induced in the stem cell donor, can be     passively transferred to the allogeneic SCT recipient in the setting of a non-myeloablative     conditioning regimen.      Secondary Objectives:      To evaluate the effect of the Fludarabine-(etoposide, doxorubicin, vincristine, prednisone,     cyclophosphamide) EPOCH regimen on host T cell depletion and myeloid depletion prior to     allogeneic SCT.      To determine the efficacy of a novel conventional chemotherapy regimen (Fludarabine-EPOCH) in     the setting multiple myeloma.      To determine the treatment-related morbidity and mortality of allogeneic stem cell     transplantation using a non-myeloablative conditioning regimen in multiple myeloma.      To determine if the re-vaccination of allogeneic stem cell donors with the unique idiotype     expressed by the recipient's myeloma will enhance cellular and humoral immunity to patient     specific-idiotype prior to lymphocyte donation for the treatment of patients with recurrent     or progressive disease after transplantation.      Eligibility:      Patients 18-75 years of age with Immunoglobulin G (IgG) or Immunoglobulin A (IgA) multiple     myeloma.      Patients must have achieved at least a partial remission following initial conventional     chemotherapy regimen or after autologous stem cell transplantation.      Consenting first degree relative matched at 6/6 or 5/6 human leukocyte antigen (HLA)     antigens.      Design:      Phase 2 trial using a non-myeloablative conditioning regimen to reduce treatment-related     toxicity.      Recipient will undergo a plasmapheresis to obtain starting material for the isolation of     idiotype      protein. Donors would be immunized with an Id vaccine prepared from the patient.      Prior to transplantation patients would receive a conventional chemotherapy regimen which     contains agents active in myeloma and is T cell depleting. The allogeneic SCT would be     performed with a conditioning regimen consisting of cyclophosphamide and fludarabine. The     stem cell source would be blood mobilized with filgrastim. Recipients will be immunized with     the Id vaccine following transplantation.   "
166371|NCT00006194|"     Decreased skeletal muscle mass is a prevalent condition among the elderly, and an important     cause of disability and functional decline. The declines in muscle mass associated with aging     may be related to alterations in specific kinds of growth factors in the muscle. Elderly hip     fracture patients often have significant decreases in muscle mass. The purpose of this study     is to investigate whether an exercise program can induce changes in muscle growth factors     that are associated with increases in muscle mass and strength in elderly hip fracture     patients.   "
166364|NCT00006186|"     Dilution of blood caused by cardiopulmonary bypass (the heart-lung machine) during open heart     surgery is associated with decreased concentrations in the blood of coagulation factors. This     can be extreme in infants because of their small blood volumes and can lead to impairment of     the normal blood clotting mechanism and excessive bleeding after the operation. Transfusion     of fresh whole blood has been shown to be an effective treatment because fresh blood is rich     in coagulation factors. However, it is difficult to obtain truly fresh blood from a blood     bank. We hypothesized that fresh blood drawn from the patient and given back after     cardiopulmonary bypass would improve the clotting mechanism. In our study, the infants in the     treatment group have some of their own fresh blood removed after they are anesthetized for     the operation and before they are placed on cardiopulmonary bypass. This blood is then given     back to them after completion of cardiopulmonary bypass. Infants in the control group will     not have their own blood removed but will undergo cardiopulmonary bypass. We will compare the     two groups by drawing blood samples that measure coagulation tests.   "
166365|NCT00006187|"     This is a 15-month study with two phases. During the first 12-month phase of this study,     patients will be randomly assigned to receive either active study drug or placebo     (approximately half of all patients will be on active study drug, the other half on placebo).     The second phase is a 3-month randomized withdrawal period. For this phase approximately 10%     of the patients will remain on the active drug.   "
166366|NCT00006188|"     This study offers evaluation and treatment for patients with inflammatory eye diseases, such     as uveitis. The protocol is not designed to test new treatments; rather, patients will     receive current standard of care treatments. The purpose of the study is twofold: 1) to allow     National Eye Institute physicians to increase their knowledge of inflammatory eye conditions     and identify new avenues of possible research in this area; and 2) to establish a pool of     patients who may be eligible for new studies as they are developed. (Participants in this     protocol will not be required to join a new study; the decision will be voluntary.)      Children and adults with uveitis and other inflammatory eye diseases may be eligible for this     study. Candidates will be screened with a medical history, brief physical examination,     thorough eye examination and blood tests. The eye examination includes measurements of visual     acuity (ability to see the vision chart), eye pressure and dilation of the pupils to examine     the lens and retina (back part of the eye). Patients may also undergo the following     procedures:        1. Fundus photography - Special photographs of the inside of the eye to help evaluate the          status of the retina and evaluate changes that may occur in the future. From 2 to 20          pictures may be taken, depending on the eye condition. The camera flashes a bright light          into the eye for each picture.        2. Fluorescein angiography - Procedure to evaluate the eye's blood vessels. A yellow dye          injected into an arm vein travels to the blood vessels in the eyes. Pictures of the          retina are taken using a camera that flashes a blue light into the eye. The pictures          show if any dye has leaked from the vessels into the retina, indicating possible blood          vessel abnormality.      Participants will be followed at least 3 years. Follow-up visits are scheduled according to     the standard of care for the individual patient's eye problem. Vision will be checked at each     visit, and some of the screening tests described above may be repeated to follow the progress     of disease and evaluate the response to treatment.   "
166367|NCT00006190|"     HIV infection is a major global health problem. Survival and quality of life for HIV subjects     has tremendously improved with the advent of a class of antivirals called protease inhibitors     and the utilization of highly active combination therapy. However, such therapy has been     associated with a syndrome called lipodystrophy. This lipodystrophy syndrome causes body     shape changes; typically thinning and loss of fat from the arms, legs and face, with     increased fat appearing in the abdomen and neck. There are also metabolic changes which     occur, and subjects can develop increased triglycerides, increased cholesterol and an     increased risk for diabetes as indicated by increasing insulin resistance. This study will     take HIV positive subjects who have not yet started antiviral medications (treatment     naive)and randomly assign them to one of two treatment arms. These treatment arms will be:     Sustiva/Zerit/Epivir vs. Viracept/Zerit/Epivir The subjects will be treated and followed for     two years and have extensive metabolic testing, skinfold thickness measurements, MRI scans     and other measures to determine if and how they are experiencing changes in metabolism or     body shape and to discover the mechanism of why this occurs. Understanding the mechanism     should allow researchers to design interventions for subjects who have lipodystrophy and     strategies to prevent lipodystrophy from occurring to subjects treated with antivirals in the     future.   "
166368|NCT00006191|"     This study will examine the effect of the newly developed anti-epileptic drug, levetiracetam,     on excitability of the cortex (surface layer) of the brain. Levetiracetam works differently     from other anti-seizure drugs, but its mechanism is not well understood. This study may     provide insight into a new protection mechanism against seizures as well as the effect of the     drug on cortical excitability.      Healthy normal volunteers 18 years of age and older may be eligible for this study.     Candidates will have a medical history taken and undergo physical and neurological     examinations.      Participants will undergo two different procedures in four separate sessions. One procedure     (cortical excitability) involves taking either levetiracetam or placebo (a look-alike     inactive substance) and having transcranial magnetic stimulation (TMS). The other procedure     (pinch-training related changes) involves taking levetiracetam or placebo, doing a motor     exercise called pinch training, and having transcranial magnetic stimulation. For TMS, a very     brief electrical current is passed through an insulated coil wire placed on the scalp. The     magnetic pulse travels through the scalp and skull, causing small electrical currents in the     cortex that may cause muscle, hand, or arm twitching or it may affect movements or reflexes.     During the study, subjects may be asked to make movements, do simple tasks or tense muscles.     Electrical activity of the muscles will be recorded using electrodes taped to the skin over     the muscle. For the pinch training, the subject makes a brief, brisk pinch after each beat of     a metronome every two seconds and then completely relaxes the hand until the next beat.      Subjects will be tested on four different days at least 72 hours apart. Each session will     last about 3 to 4 hours.      Approximate schedule for cortical excitability testing:      TMS (study 1)      Take levetiracetam or placebo      TMS (study 2) < 60 minutes after drug or placebo      TMS (study 3) < 120 minutes after drug or placebo      Approximate schedule for pinch-training related changes:      Take levetiracetam or placebo      TMS and pinch power measurement < 60 minutes after drug or placebo      Pinch training for 30 minutes      TMS and pinch power measurement      Sample schedule:      Session 1 < LTC and cortical excitability testing      Session 2 < Placebo and cortical excitability testing      Session 3 < LTC and pinch-training related changes      Session 4 < Placebo and pinch-training related changes   "
166369|NCT00006192|"     To document cardiovascular disease and cardiovascular disease risk factors among 1,200 Native     Alaskans who are members of approximately 40 families.   "
166370|NCT00006193|"     Dr. Atkins' New Diet Revolution has sold over 10 million copies and has been on the New York     Times best seller list for 158 weeks. This and other low-carbohydrate diets, such as the     ZONE, Sugar Busters, and the Carbohydrate Addicts Diet, have attracted much popular attention     but little scientific evaluation. Given the widespread use of these diets, it seems prudent     to evaluate them both for safety and efficacy. Therefore, the purpose of the study is to     compare the effectiveness of two different weight control programs over the course of 52     weeks. These two programs are 1) the Atkins' New Diet Revolution, a low-carbohydrate,     high-protein diet, and 2) Brownell's LEARN Program, a high carbohydrate, low fat diet based     on behavior modification. Specifically, this study will compare short-term changes in weight,     food intake, blood chemistries and mood in adult males (n=10) and females (n=10) who are     randomized to either the Atkins' Diet or the LEARN Program for a period of one year. During     this year, they will be under medical supervision. We will examine the effect of the two     weight loss plans on changes in lipids, blood pressure, insulin sensitivity and ketones, and     eating behavior. This is a feasibility study and thus the data will ultimately be used to     design a large randomized trial with adequate statistical power.   "
166372|NCT00006195|"     The overall purpose of this research is to look at how two of the most commonly prescribed     newer antipsychotic medications, risperidone and olanzapine, affect substances in the body     such as glucose and insulin. Undesirable changes in blood sugar control, or glucose     regulation, and type 2 diabetes can occur more commonly in individuals with schizophrenia     compared to healthy subjects and subjects with other psychiatric conditions. While     abnormalities in glucose regulation were first reported in schizophrenia before the     introduction of antipsychotic medications, antipsychotic treatment may contribute     significantly to abnormalities in glucose regulation. Attention to the way that antipsychotic     medications may affect glucose regulation has increased as doctors have become more concerned     in general about disease- and drug-related medical complications, including weight gain     during antipsychotic treatment.   "
166373|NCT00006196|"     Vitamin D deficiency is common in the elderly and contributes to the increased incidence of     falls, hip fracture and depression in this population. An unknown number of elderly have     vitamin D resistance resulting in a functional vitamin D deficiency state. Because there are     no simple procedures or blood tests that identify vitamin D resistance, its prevalence and     contribution to disability in the elderly is unknown. Our inability to screen for this     condition precludes our ability to initiate and monitor treatment.      Previous studies indicate that fingernail thickness correlates with vitamin D status and may     therefore provide a simple cost effective procedure to not only identify patients with     vitamin D deficiency but also, those with vitamin D resistance. This procedure may also     provide a way to monitor an individual's response to treatment.      This study is designed to demonstrate the association between fingernail thickness and     vitamin D status.   "
166374|NCT00006198|"     This is a clinical trial to test the safety and efficacy of the drug thalidomide in     combination with a procedure called chemoembolization in patients with inoperable liver     cancer. Chemoembolization is the process by which chemotherapy is instilled directly into the     blood vessels feeding the tumor, so that the blood vessels feeding the tumor may be blocked.     Chemoembolization consists of two separate procedures. It will be done by infusing     chemotherapy with the drug doxorubicin through the hepatic artery into the liver and then by     infusing collagen to cut off the blood supply to the tumor. A catheter will be inserted at     various times to allow for these infusions.      The objectives are to investigate the feasibility and potential activity of chronic     administration of thalidomide in patients with unresectable hepatocellular cancer who receive     chemoembolization to predominant tumor masses. The toxicity of thalidomide in these patients     will be evaluated. Overall safety will also be assessed. Serum levels of angiogenic cytokines     such as VEGF, bFGF, and TNF-a, that are believed to have a role in hepatocellular carcinoma,     will be collected.   "
166375|NCT00006199|"     The purpose of this clinical trial is to establish the safest doses for the combination of a     farnesyl transferase inhibitor, R115777 plus topotecan in patients with advanced solid     tumors, previously treated or beyond standard therapy of clinical benefit. Maximum tolerated     dose, dose limiting toxicity and the activity of this combination will be assessed.      This chemotherapy regimen is a two-pronged attack at the way cancer cells replicate. R115777     is a compound that may inhibit cancer cell growth by interfering with the p21 ras oncogene,     while topotecan, a topoisomerase-1 inhibitor, works on cancer cells not subject to control by     the ras oncogene. Animal studies suggest that the combination may be synergistic. Another     advantage is that R115777 can be taken by mouth.   "
166376|NCT00006200|"     The purpose of this clinical trial is to assess the activity of thalidomide in combination     with dacarbazine (DTIC) in patients with metastatic melanoma. Safety and toxicity of the two     drugs will also be assessed. Dacarbazine is the standard medical treatment for metastatic     melanoma. It has been shown to produce tumor shrinkage in approximately 20% of patients with     advanced melanoma. This shrinkage is usually incomplete and lasts a short time. Thalidomide     is a drug that inhibits tumor blood vessel growth. It can be given orally. It is hoped that     this combination can be given to patients with metastatic melanoma without causing too much     toxicity while increasing the response rate.   "
166377|NCT00006202|"     This study will examine whether taking the vitamin lutein changes lutein blood levels.     Lutein, vitamin C, vitamin E and beta-carotene may be useful in treating the eye disease     age-related macular degeneration, but more information is needed to support this. Age-related     macular degeneration can significantly impair the ability to read, drive, and carry out daily     activities. It is the most common cause of vision loss in people over age 60. Lutein a     carotenoid that occurs naturally in the retina (the back part of the eye), especially the     macula-the part of the retina that is important for fine, detailed vision.      Men and women 60 years of age and older, with or without age-related macular degeneration,     may be eligible for this study. Candidates will undergo the following tests:        1. Medical history and physical examination.        2. Eye examination-Includes evaluation of visual acuity, measurement of eye pressure,          examination of the lens, retina, pupils and eye movements, and photographs of the eye.        3. Visual field study-Examines the ability to see objects in the periphery. The subject          looks at a target on a screen and indicates when lights that appear in other places on          the screen are visible.        4. Flicker photometry-The subject looks at a flashing light and turns a knob until the          light stops flashing.        5. Blood tests-To measure blood levels of lutein and other carotenoids, liver function,          cholesterol and triglycerides.      Participants will be randomly assigned to take one of three dosages of lutein (2.5     milligrams, 5 milligrams or 10 milligrams) for 6 months and will be examined at follow-up     visits scheduled 1, 3, 6, 9 and 12 months after starting lutein. During these visits, many of     the exams described above will be repeated to evaluate the effects of lutein treatment on the     eye.   "
166378|NCT00006203|"     This 5-week study will examine the effects of naltrexone on alcohol craving, drinking rates,     and reaction to drinking-related triggers, or cues, in participants' everyday environment and     in laboratory sessions. Participants will monitor and record their daily desires to drink,     environmental circumstances in which urges occur, and drinking behavior using a palm top     computer. Participants will receive naltrexone or a placebo. One week after receiving     medication, all participants will be asked to respond to alcohol-related cues that may or may     not arouse the desire to drink.   "
166643|NCT00017212|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients     who have metastatic stomach cancer.   "
166382|NCT00008541|"     This study offers evaluation and treatment for patients with certain corneal and external     diseases of the eye (diseases of the surface of the eye and its surrounding structures). The     protocol is not designed to test new treatments; rather, patients will receive current     standard of care treatments. The purpose of the study is twofold: 1) to allow National Eye     Institute physicians to increase their knowledge of various corneal and external conditions     and identify possible new avenues of research in this area; and 2) to establish a pool of     patients who may be eligible for new studies as they are developed. (Participants in this     protocol will not be required to join a new study; the decision will be voluntary.)      Children and adults with corneal or external eye diseases may be eligible for this study.     Candidates will be screened with a medical history, brief physical examination, thorough eye     examination and blood test. The eye examination includes measurements of eye pressure and     visual acuity (ability to see the vision chart) and dilation of the pupils to examine the     lens and retina (back part of the eye). Patients will also undergo the following procedures:        1. Eye photography - Special photographs of the inside of the eye to help evaluate the          status of the cornea and conjunctiva (the most superficial layer of the eye) evaluate          changes that may occur in the future. From two to 20 pictures may be taken, depending on          the eye condition. The camera flashes a bright light into the eye for each picture.        2. Conjunctival or lacrimal gland biopsy - A small piece of the conjunctiva or the lacrimal          (tear) gland, is removed for examination under the microscope. Anesthetic drops and          possibly an injection of anesthetic are given to numb the eye. An antibiotic ointment          and patch may be placed over the eye for several hours after the procedure.      Participants will be followed at least 3 years. Follow-up visits are scheduled according to     the standard of care for the individual patient's eye problem. Vision will be checked at each     visit, and some of the tests described above may be repeated to follow the progress of     disease and evaluate the response to any treatment that is given.   "
166383|NCT00008554|"     The purpose of this study is to compare GW433908 and nelfinavir when each is given with     abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.   "
166384|NCT00008697|"     The purpose of this study is to evaluate both the efficacy and toxicity of infusional arsenic     trioxide in the treatment of patients with relapsed or refractory acute promyelocytic     leukemia (APML). In addition, correlation between pharmacokinetic data and both therapeutic     response and therapy-related toxicities will be sought.   "
166385|NCT00008736|"     Serial EGC measurements in premature infants attempting to correlate EGC measurements with     signs of feeding intolerance and response to metoclopramide therapy.   "
166386|NCT00008749|"     Systemic lupus erythematosus is an often devastating autoimmune disease which affects 1 in     2,000 women in the United States. Recently, several research laboratories have reported that     a protein, named CD40-ligand (CD154), is overexpressed by a subset of white blood cells,     called lymphocytes, in patients with lupus. Expression of CD154 appears critical to the     generation of antibodies that cause disease in lupus. Blocking CD154 interactions in the     immune system has been shown to decrease disease activity in animal models of lupus. We     propose to study the regulation of CD154 in patients with lupus in hopes of inhibiting its     abnormal and deleterious expression.   "
166387|NCT00008762|"     People with cystic fibrosis (CF) now frequently live into adulthood and with this extended     life expectancy has come new clinical problems. Poor bone health, including osteoporosis and     bone fractures, is one of these increasingly important conditions. Preventing the negative     outcomes of poor bone health in later life is primarily related to ensuring optimal growth     (weight and height) and obtaining maximal amount of bone mass during growth and development.     This study will identify factors that influence bone health in a sample of children,     adolescents and young adults as measured by dual energy x-ray absorptiometry and new bone     densitometry methods (peripheral quantitative computerized tomography [p-QCT] and bone     sonometer). We will also identify factors which influence changes in bone status over a     12-month follow-up period in a subsample of people with CF.   "
166388|NCT00008775|"     Chest physiotherapy is recognized as a mainstay of cystic fibrosis therapy, and is     particularly important during treatment of pulmonary exacerbations. For some patients,     especially those with moderate to severe compromise of lung function, this therapy may impose     a high demand in the work of breathing and energy expenditure. The goal of this study is to     evaluate the effectiveness of adding pressure support ventilation (PSV) during chest     physiotherapy sessions in patients with cystic fibrosis with moderate to severe lung function     compromise being treated for a pulmonary exacerbation.   "
166389|NCT00008788|"     This pilot project aims to 1) estimate the prevalence of osteoporosis in adults having     undergone liver transplantation in childhood, and 2) identify risk factors for osteoporosis     in this group. We aim to study 40 individuals.   "
166390|NCT00008801|"     The broad, long-term goal of this proposal is to improve the results and applicability of     islet allotransplantation early in the course of type 1 diabetes through the administration     of selective and short-term immunotherapy. More specifically, the objectives of these studies     is to conduct an open-labeled, one-year follow-up Phase I/II study in patients with surgical     and type 1 diabetes to determine the safety, tolerability, immune activity, and     pharmacokinetics of hOKT3gamma1 (Ala-ala) administration for the prevention of autoimmune     destruction and rejection of allogeneic islet transplants.   "
166391|NCT00008814|"     The study proposes to evaluate cognitive development in infants four months or younger by     functional MRI and event related potential recording. fMRI imaging will be obtained following     an auditory stimulus inside the 4 tesla magnet at the Center for Magnetic Resonance Research     and will be correlated with ERP response to the same stimulus.   "
166392|NCT00008827|"     This project is assessing the effectiveness of using the Internet as a tool to facilitate the     maintenance of weight lost in a behavioral weight control program. Participants attend a     standard behavioral weight control intervention via Interactive Television and after 6 months     are randomly assigned to one of three groups; a control group, an in-person weight     maintenance group and a maintenance group that meets over the Internet. This research project     is being conducted in Vermont.   "
166393|NCT00008840|"     The purpose of this study is to evaluate the safety and effectiveness of 2 drugs (AmBisome     versus voriconazole) in treating fungal infections. Immunocompromised patients, especially     those with persistent fever and neutropenia, are at a high risk of developing deeply     invasive, life-threatening fungal infections with Candida, Aspergillus, and other     opportunistic fungal pathogens. The risk of fungal infection increases in direct proportion     with severity of neutropenia and duration of fever. Antifungal therapy, therefore, is an     important step in the amelioration of fungal disease.   "
166412|NCT00014287|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving the drugs in different ways may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of gemcitabine given directly into the     bladder in treating patients who have recurrent or refractory bladder cancer.   "
166395|NCT00008866|"     The purpose of this study is to find out whether or not the addition of hydroxyurea to     didanosine (ddI) and other anti-HIV medications will result in better control of HIV     infection.      The Food and Drug Administration (FDA) has approved ddI for treating HIV infections.     Hydroxyurea is approved for treating some cancers and blood disorders. It works against HIV-1     when combined with ddI. Researchers need to look at how well patients may respond to     hydroxyurea in combination with ddI and other anti-HIV drugs, and at any side effects.   "
166396|NCT00008892|"     The purpose of this study is to use brain imaging technology to study the connections between     brain regions in children with attention deficit hyperactivity disorder (AD/HD), and     comparing them to children without AD/HD.      This study will build upon previous brain imaging studies of healthy volunteers and children     who have AD/HD. This study will use diffusion tensor magnetic resonance imaging (DT-MRI) to     visualize and measure certain parts of the brains of identical twin pairs in which one twin     has AD/HD, combined type.      Participants in this study will be screened with questionnaires and interviews, psychometric     testing, and a physical examination. Participants' medical and educational records may be     reviewed. Participants will undergo an MRI scan of the brain. Prior to the MRI, participants     will have a training session in a simulated MRI scanner to learn how to lie still during MRI     scanning. Participants may be asked to return for a follow-up scan in about 2 years.   "
166397|NCT00009009|"     This study will examine the safety and effectiveness of renal (kidney) transplantation for     HIV-infected patients with end-stage renal disease (kidney failure). Although kidney     transplant is the best treatment for most causes of kidney failure, people infected with HIV     are not offered this procedure because the immunosuppressive drugs (drugs that suppress     immune function) required to prevent organ rejection could further impair the patient's     already weakened immune system. This study will use a regimen of immunosuppressants designed     to complement treatment for patients taking highly active antiretroviral therapy (HAART).      HIV-infected patients between 18 and 60 years of age with renal failure who have not had any     opportunistic infections for 5 years may be eligible for this study. Candidates will be     screened with a medical history, physical examination, and blood and urine tests.      Before the transplant procedure, participants will undergo additional tests and procedures,     including blood studies, 24-hour urine collection, infectious disease consultation,     tuberculin skin test, PAP smear for women, chest X-ray, brain and hip MRI studies and     DEXA-scan to evaluate bone density. In addition, patients may undergo leukapheresis to obtain     white blood cells for study. For this procedure, whole blood is drawn through a needle in an     arm vein and passed through a cell separator machine. The white cells are collected for     removal, and the rest of the blood is returned to the body through the same needle or another     needle in the other arm.      When a donor organ becomes available for transplant, the patient will receive three     anti-rejection drugs-cyclosporine, mycophenolate mofetil and prednisone-to prevent organ     rejection. Immediately after the surgery, HAART drugs will be stopped for 7 days until stable     levels of the immune suppressants can be achieved. Then, HAART will be re-started and all     medications will be adjusted to achieve adequate blood levels. Patients must stay in the     local area 60 days after discharge from the hospital for monitoring. Frequent blood samples     will be taken to monitor kidney function, viral load and CD4+ T cell counts. Follow-up visits     will then be scheduled monthly for the first 6 months after transplant, then every other     month for 1 year. Kidney biopsies will be done at the end of the first month, after 6 months,     and yearly for 5 years. For the biopsy, a special needle is used to remove a small piece of     kidney tissue for microscopic examination. The biopsies and blood tests are done to evaluate     the immune response to the transplanted organ and to study how HAART interacts with the     immune suppressing drugs.   "
166398|NCT00009035|"     This study offers evaluation of patients with brain and spinal cord tumors. Its purpose is     threefold: 1) to allow physicians in NIH s Neuro-Oncology Branch to increase their knowledge     of the course of central nervous system tumors and identify areas that need further research;     2) to inform participants of new studies at the National Cancer Institute and other centers     as they are developed; and 3) to provide patients consultation on possible treatment options.      Children (at least 1 year old) and adults with primary malignant brain and spinal cord tumors     may be eligible for this study. Participants will have a medical history, physical and     neurological examinations and routine blood tests. They may also undergo one or more of the     following procedures:        -  Magnetic resonance imaging (MRI) MRI is a diagnostic tool that uses a strong magnetic          field and radio waves instead of X-rays to show detailed changes in brain structure and          chemistry. For the procedure, the patient lies on a table in a narrow cylinder          containing a magnetic field. A contrast material called gadolinium may be used (injected          into a vein) to enhance the images. The procedure takes about an hour, and the patient          can speak with a staff member via an intercom system at all times.        -  Computed axial tomography (CAT or CT) CT is a specialized form of X-ray imaging that          produces 3-dimensional images of the brain in sections. The scanner is a ring device          that surrounds the patient and contains a moveable X-ray source. The scan takes about 30          minutes and may be done with or without the use of a contrast dye.        -  Positron emission tomography (PET) PET is a diagnostic test that is based on differences          in how cells take up and use glucose (sugar), one of the body s main fuels. The patient          is given an injection of radioactive glucose. A special camera surrounding the patient          detects the radiation emitted by the radioactive material and produces images that show          how much glucose is being used by various tissues. Fast-growing cells, such as tumors,          take up and use more glucose than normal cells do, and therefore, the scan might          indicate the overall activity or aggressiveness of the tumor. The procedure takes about          an hour.      When all the tests are completed, the physician will discuss the results and potential     treatment options with the patient. Follow-up will vary according to the individual. Some     patients may end the study with just one visit to NIH, while others may be followed at NIH     regularly, in conjunction with their local physicians. Patients with aggressive tumors may be     seen every 3 or 4 months, while those with less active tumors may be seen every 6 to 12     months. Permission may be requested for telephone follow-up (with the patient or physician)     of patients not seen regularly at NIH.   "
166413|NCT00014300|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of glufosfamide in treating patients who     have recurrent glioblastoma multiforme.   "
166414|NCT00014313|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have metastatic Ewing's sarcoma or primitive neuroectodermal tumor.   "
166415|NCT00014326|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation     therapy in different ways may kill more tumor cells. It is not yet known which regimen of     radiation therapy is more effective for non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the     involved area with or without total-body irradiation in treating patients who have low-grade     stage I or stage II non-Hodgkin's lymphoma that has not previously been treated.   "
166452|NCT00014859|"     The purpose of this study is to test the hypothesis that excess, rare, functionally     disruptive single nucleotide polymorphisms (SNPs) characterize genes (e.g., the surfactant     protein-B gene)(SFTPB) and gene networks (e.g., the pulmonary surfactant metabolic network)     associated with increased risk of neonatal respiratory distress syndrome (RDS).   "
166420|NCT00014391|"     RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is     not yet known if ribavirin is more effective with or without monoclonal antibody therapy in     treating patients who develop RSV pneumonia following peripheral stem cell transplantation.      PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with or without     monoclonal antibody in treating patients who develop RSV pneumonia following peripheral stem     cell transplantation.   "
166399|NCT00009048|"     This study will evaluate the effects of an experimental drug called EMD 128130 on Parkinson's     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of     long-term treatment with levodopa. EMD 128130 inhibits the function of serotonin, a chemical     messenger thought to regulate dopamine release, and thus affect Parkinson's disease symptoms.      Patients with relatively advanced Parkinson's disease between 30 and 80 years of age may be     eligible for this 3-phase study.        -  Phase 1 - Baseline Evaluation      Participants will have a medical history, physical examination, detailed neurologic     evaluation, routine blood tests, urinalysis and an electrocardiogram. A chest X-ray and MRI     or CT scan of the brain will be done if needed. In addition, an ACTH stimulation test will be     done before and at the end of the study. For this test, a hormone called ACTH is injected     into a vein. A small amount of blood is drawn before the injection and 30 and 60 minutes     afterwards to measure levels of another hormone called cortisol. After these tests are     completed, patients will, if possible, stop taking all antiparkinsonian medications except     levodopa (Sinemet) for one month before the study begins and throughout its duration.        -  Phase 2 - Levodopa and Apomorphine Dose Finding      For 1 to 3 days, patients will be admitted to the NIH Clinical center to undergo a levodopa     and apomorphine (a dopamine agonist) dose-finding procedure. For this procedure, patients     will stop taking Sinemet and instead will have levodopa, and subsequently apomorphine,     infused through a vein. During the infusions, the drug dose will be increased slowly until     either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the     maximum study dose is reached. Symptoms will be monitored frequently to find two infusion     rates: 1) one that is less than what is needed to relieve symptoms, and 2) one that relieves     symptoms but may produce dyskinesias.        -  Phase 3 - Active Study      Patients will begin the treatment phase within 3 months of the dose-finding phase. After a     brief physical examination, routine blood tests, and evaluation of parkinsonism symptoms,     patients will begin taking either EMD 128130 tablets or capsules or a placebo (a look-alike     pill with no active ingredient) twice a day, along with Sinemet, for 3 weeks. All     participants will receive placebo at least 1 week during the study, and about four patients,     selected at random, will receive only placebo the entire 3 weeks. Levodopa and apomorphine     infusions will be repeated at the end of weeks 1, 2 and 3 of Phase 3. The procedure for the     infusions will be the same as in the dose-finding phase.      Throughout the study, parkinsonian symptoms and dyskinesias will be assessed and blood     samples will be drawn periodically to measure drug levels. Patients will return for a     follow-up evaluation 2 weeks after the end of the study.   "
166400|NCT00009061|"     The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral     response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that     have not taken antiretroviral (ART) drugs.   "
166401|NCT00009178|"     Bulimia Nervosa is a frequent problem for young women. It is widely assumed that this     disorder cannot be treated effectively in a primary care setting. This assumption has never     been tested empirically, and is probably incorrect.      In the last 15 years, effective treatment interventions for Bulimia Nervosa have been     developed and validated in specialized treatment centers. The broad aim of this proposal is     to examine whether these treatments, suitably adapted, can be usefully transferred to general     health care settings. Specifically, the proposed study will determine the relative and     combined effectiveness of the two leading treatments for Bulimia Nervosa in a primary care     setting. The two major interventions are treatment with an antidepressant medication,     fluoxetine, and with a form of cognitive behavioral therapy, guided self-help, designed for     use in primary care.   "
166402|NCT00009191|"     Major depression afflicts approximately 25 percent of patients with AD. Depression in AD     patients leads to mental suffering, behavioral disturbance (such as aggression), poor     cognition, poor self-care, caregiver depression, caregiver burden, and early entry into the     nursing home. Since major depression is treatable, this additional disability may be     avoidable. The use of antidepressants to treat major depression in AD is supported by two     studies, although a third does not show a benefit for antidepressants over placebo. Also, the     safety of antidepressant treatment in depressed AD patients is poorly studied. A conclusive     study showing that depression reduction in AD can be accomplished safely with antidepressant     medications, and that depression reduction is associated with improvements in activities of     daily living, non-mood behavioral disturbances, caregiver burden, and caregiver depression     would have major clinical and cost implications for the care of the AD patient. This study is     a 13-week, double blind, flexible dose, placebo controlled trial of sertraline in the     treatment of outpatients with AD and co-morbid major depression. The hypothesis is that     antidepressant treatment is superior to placebo in improving mood, in improving cognition, in     reducing physical dependency, in reducing caregiver depression, and in reducing caregiver     burden. It is also hypothesized that the degree of depression reduction is correlated with     these improvements. It is further hypothesized that the safety profile of sertraline when     compared to placebo is acceptable, especially with regard to risk of falls, sleep     disturbance, and delirium. One hundred community residing outpatients with probable AD who     also meet DSM-IV criteria for major depressive episode will be recruited into the study. They     will be randomized to sertraline or placebo and followed through weekly telephone contact by     an experienced clinical trials team. Outcomes will be assessed every 3 weeks, for a total of     four followup data points. Scales assessing the following domains will be used: depression,     cognition, behavioral disturbance, physical dependency, delirium, falls, sleep, other side     effects, caregiver depression, caregiver burden, caregiver functioning, and caregiver health.   "
166403|NCT00009204|"     This study is a randomized, double-blind, placebo-controlled, fixed dose study currently     being conducted on two geropsychiatric units at Western Psychiatric Institute and Clinic. It     seeks to evaluate the short-term safety and efficacy of citalopram and perphenazine in the     treatment of 112 patients suffering from behavioral disturbances associated with dementia.     Findings from this research may directly lead to improved acute pharmacotherapy for psychosis     and behavioral problems in patients diagnosed with dementia. Improved treatment of behavioral     complications with reduced side effects would reduce excess disability in patients diagnosed     with dementia, allowing them to be maintained in the community for greater periods of time.   "
166404|NCT00009217|"     The optimal strategy for the treatment of behavioral complications in patients with probable     Alzheimer's disease (AD) remains unclear.      The objective of this study is to evaluate the risk of relapse following discontinuation of     haloperidol in patients with Alzheimer's disease (AD) with psychosis or agitation who respond     to it.      In Phase A of this study, AD outpatients with behavioral complications receive 20 weeks of     open haloperidol treatment with an oral dose of 1-5 mg daily, titrated individually to     achieve the optimal trade-off between efficacy and side effects. Responders to Phase A     participate in Phase B, a 24-week continuation trial in which patients are randomized to     continuation haloperidol or placebo.      The primary outcome is the time to relapse of psychosis or behavioral disturbance.   "
166416|NCT00014339|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Enzyme products such as Wobe-Mugos E may help to reduce the side     effects of multiple myeloma therapy. It is not yet known if chemotherapy is more effective     with or without Wobe-Mugos E in treating multiple myeloma.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or     without Wobe-Mugos E in treating patients who have stage II or stage III multiple myeloma.   "
166417|NCT00014352|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.     Anticoagulant drugs such as warfarin may reduce the risk of blood clots.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus warfarin     in treating patients who have prostate cancer.   "
166418|NCT00014365|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase I trial to determine if Ro 31-7453 is more effective with or     without food in treating patients who have metastatic solid tumors.   "
166453|NCT00014872|"     To investigate the role of genes and energy metabolism in the pathogenesis of obesity in     adolescent Black girls.   "
166405|NCT00009230|"     This project is designed to study whether anti-inflammatory drugs, such as celecoxib, may     delay age-related mental decline. We are also looking at genetic risk and brain structure as     potential predictors of mental decline. We believe people with age-associated memory     impairment who take celecoxib will show less evidence of mental decline than those receiving     placebo (an inactive pill) after 18 months. We expect that brain structure at the start of     the study, memory performance as indicated by tests, and age will be additional predictors of     mental decline. We also predict that cognitive decline (i.e., decline in thinking and memory)     and treatment response will vary according to genetic factors that may correlate with the age     at which dementia begins. We believe other variables such as prior educational achievement,     memory capability at the outset of the study, and gender may influence mental decline and     treatment response. We will study people with age-associated memory impairment (mild memory     complaints, decreased performance in selected memory tests), between 40 and 90 years of age.     The subjects will be randomly (i.e., by a process similar to flipping a coin) assigned to     treatment groups. The subjects will receive either an inactive substance (placebo) or     celecoxib (400 mg/day). The subjects will receive a magnetic resonance imaging (MRI) scan,     FDG PET scan, routine laboratory blood tests, electrocardiogram and cognitive tests. They     will be followed for approximately 18 months and asked to return at specific intervals for     follow-up testing. Measures of brain structure will be derived from baseline MRI scans and     metabolic activity from PET scans, and blood will be drawn and tested to determine which     forms (genotypes) of certain genetically determined cellular components the patient has.   "
166406|NCT00009243|"     The purpose of this study is to learn more about stroke and obtain information that may serve     as the basis for future investigations. It will 1) establish a registry of patients with     cerebrovascular disease (stroke); 2) characterize the natural history of acute stroke and     transient ischemic attacks (TIA) an interruption of blood flow to the brain that causes     stroke symptoms for a short period of time); and 3) evaluate the data to generate ideas for     future studies.      Patients 18 years of age or older with suspected acute stroke or TIA may be eligible for this     study. Subjects will be recruited from patients who present with stroke at the emergency     department of Suburban Hospital in Bethesda, Maryland.      The study will gather data collected from diagnostic and laboratory tests the patient     undergoes as part of standard medical care, including findings of medical and neurological     examinations and other tests. In addition, studies will be done for research purposes only to     gather data about stroke and TIA. These may include the following:        -  Blood and urine tests not more than 2 tablespoons of blood will be drawn for various          tests.        -  Electrocardiogram (EKG) (heart tracing) electrodes placed on the chest wall detect the          heartbeat and heart rhythm.        -  Computed tomography (CT) scan of the head specialized X-rays are used to obtain images          of the brain.        -  Magnetic resonance imaging (MRI) of the brain a strong magnetic field and radio waves          are used to produce images that provide information about the brain tissue and blood          vessels.        -  Transcranial Doppler (TCD) sound waves are used to image the arteries of the brain and          neck.        -  Echocardiogram sound waves are used to image the heart and evaluate heart function.      Patients may be asked to return to Suburban Hospital for follow-up testing in 1, 3, and/or 12     months, when some of these tests may be repeated to assess changes over time   "
166407|NCT00009256|"     The purpose of this study is to gain knowledge about why drug therapy sometimes stops working     in people infected with the human immunodeficiency virus (HIV). This occurs in 30 to 40% of     patients treated with powerful antiretroviral drugs. The study will examine how the virus     becomes resistant to drug treatment through mutations (changes) and how different mutations     produce new variants that are resistant to more than one drug.      HIV-infected patients 18 years and older who have not been treated with antiretroviral     medications and who have a relatively stable amount of virus in their blood (viral load) may     be eligible for this study. Pregnant or breastfeeding women may not participate. Candidates     will be screened with blood tests to determine viral load and to study the genetics of the     virus.      Participants will be hospitalized at the NIH Clinical Center for 10 days for daily blood     sampling. (In exceptional circumstances, the sampling may be done on an outpatient basis.)     After discharge, patients will be followed by weekly visits for blood tests for a total of     120 days. When antiretroviral treatment begins, the patient may do one of the following:        1. Continue on this study with antiretroviral treatment. Therapy will consist of D4T, 3TC,          and efavirenz. Other drugs may be substituted for any of these that cannot be tolerated.          HIV protease inhibitors will not be included in the regimen.        2. Complete participation in this study and, if eligible, enroll in another NIH protocol          (AVBIO).        3. Begin standard antiretroviral therapy with a private physician.      Patients for whom treatment is not yet recommended or who choose not to be treated may     continue to be monitored with blood tests for a total of 18 months. (Patients who leave the     study after this time may re-join when they decide to start treatment.)      Participants may also undergo the following optional procedures to study the genetic     variation of HIV: lymph node biopsy, spinal tap, and semen donation or female genital washing     to collect secretion samples.      Sexual partners or needle-sharing partners of study patients are invited to enroll in this     study to provide blood samples at the time the patient enrolls and at two intervals after any     needle sharing or unsafe sex event they may report to NIH. Partners may also donate genital     secretions or semen, and a lymph node or spinal fluid sample.      Information from this study may help in the development of new drug treatments that will be     effective in controlling HIV infection when other treatments no longer work.   "
166408|NCT00014235|"     This clinical trial studies fludarabine phosphate and total-body radiation followed by donor     peripheral blood stem cell transplant and immunosuppression in treating patients with     hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor     peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop     the patient's immune system from rejecting the donor's stem cells. When the healthy stem     cells from a donor are infused into the patient they may help the patient's bone marrow make     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted     cells from a donor can make an immune response against the body's normal cells. Giving     total-body irradiation together with fludarabine phosphate, cyclosporine, and mycophenolate     mofetil before transplant may stop this from happening.   "
166409|NCT00014248|"     RATIONALE: Adenosine triphosphate may decrease weight loss and improve muscle strength in     patients with advanced solid tumors.      PURPOSE: Phase I trial to study the effectiveness of adenosine triphosphate in controlling     loss of weight and loss of muscle mass in patients who have advanced solid tumors.   "
166410|NCT00014261|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. PEG-interferon alfa-2B may interfere with the growth of cancer     cells. Combining temozolomide with PEG-interferon alfa-2B may be an effective treatment for     advanced solid tumors.      PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and     PEG-interferon alfa-2B in treating patients who have advanced solid tumors.   "
166411|NCT00014274|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is most effective for transitional cell     cancer of the urothelium.      PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens     in treating patients who have transitional cell cancer of the urothelium.   "
166419|NCT00014378|"     RATIONALE: The Chinese herb Huang Lian contains ingredients that may slow the growth of     cancer cells and may be an effective treatment for solid tumors.      PURPOSE: Phase I trial to study the effectiveness of Huang Lian in treating patients who have     advanced solid tumors.   "
166421|NCT00014404|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. The use of celecoxib may be an effective way to prevent the further     development of precancerous lesions in the mouth.      PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of     celecoxib in treating patients who have precancerous lesions in the mouth.   "
166422|NCT00014430|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells.      PURPOSE: Phase I trial to study the effectiveness of vinorelbine plus trastuzumab in treating     patients who have refractory or metastatic breast cancer.   "
166423|NCT00014443|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to     the tumor.      PURPOSE: Phase I trial to study the effectiveness of combining topotecan and thalidomide in     treating patients who have recurrent or refractory malignant glioma.   "
166424|NCT00014456|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus filgrastim     in treating patients who have advanced solid tumors.   "
166425|NCT00014469|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with bone marrow transplantation may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of busulfan and melphalan followed by     donor bone marrow transplantation in treating patients who have advanced hematologic cancer.   "
166426|NCT00014482|"     RATIONALE: Music therapy may be effective in relieving pain and emotional distress in     patients who are undergoing cancer therapy.      PURPOSE: Randomized trial to determine the effectiveness of music therapy to ease pain and     emotional distress in patients with hematologic cancer who are undergoing high-dose therapy     and stem cell transplantation.   "
166427|NCT00014495|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill     more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy and monoclonal     antibody therapy in treating patients who have advanced myeloid cancer.   "
166428|NCT00014508|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may be able to replace     immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells are     rejected by the body's tissues. Peripheral stem cell transplantation with the person's own     stem cells followed by donor peripheral stem cell transplantation may prevent this from     happening.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with autologous     peripheral stem cell transplantation and donor peripheral stem cell transplantation in     treating patients who have multiple myeloma.   "
166429|NCT00014521|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of karenitecin in treating patients who     have recurrent malignant glioma.   "
166430|NCT00014534|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in     treating patients who have advanced bladder cancer.   "
166431|NCT00014547|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BBR 3464 in treating patients who have     metastatic small cell lung cancer that has not responded to previous treatment.   "
166432|NCT00014560|"     RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing     substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients     who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.   "
166433|NCT00014573|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells. Vaccines made from a person's white blood cells and tumor cells may make the     body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's     white blood cells to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and vaccine     therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in     treating patients who have recurrent or refractory brain cancer.   "
166434|NCT00014586|"     RATIONALE: Testosterone can stimulate the growth of cancer cells. Bicalutamide and goserelin     may fight prostate cancer by reducing the production of testosterone. It is not yet known     which hormone therapy regimen is most effective for prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of bicalutamide with that of     observation followed by bicalutamide plus either goserelin or orchiectomy for patients who     have prostate cancer.   "
166435|NCT00014599|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who     have locally advanced, metastatic, or recurrent cancer of the vulva.   "
166436|NCT00014612|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less     invasive treatment and cause fewer side effects than complete axillary lymph node dissection.     It is not yet known which treatment is more effective for invasive breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph     node dissection with that of axillary radiation therapy in treating women who have invasive     breast cancer.   "
166438|NCT00014638|"     RATIONALE: Estrogen can stimulate the growth of cancer cells. Letrozole may fight breast     cancer by reducing the production of estrogen.      PURPOSE: Phase IV trial to study the effectiveness of letrozole in treating postmenopausal     women who have metastatic breast cancer that has been previously treated with tamoxifen.   "
166439|NCT00014651|"     RATIONALE: Drugs such as vapreotide may prevent complications following pancreatic resection.     It is not yet known if vapreotide is more effective than no further therapy in preventing     side effects of pancreatic resection.      PURPOSE: This randomized phase III trial is studying vapreotide to see how well it works     compared to a placebo in preventing complications in patients undergoing surgery for     pancreatic cancer.   "
166440|NCT00014664|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of two different monoclonal     antibody regimens in treating patients who have relapsed or refractory non-Hodgkin's     lymphoma.   "
166441|NCT00014677|"     RATIONALE: NBI-3001 may be able to locate cancer cells and stop them from growing. This may     be an effective treatment for glioblastoma multiforme.      PURPOSE: Randomized phase II trial to compare different regimens of NBI-3001 followed by     surgery to remove the tumor in treating patients who have glioblastoma multiforme.   "
166442|NCT00014690|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining two or more drugs may kill more tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of ZD9331     with or without topotecan in treating patients who have refractory or recurrent epithelial     ovarian cancer, fallopian tube cancer or primary peritoneal cancer.   "
166443|NCT00014729|"     OBJECTIVES:      I. Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis     bullosa.   "
166444|NCT00014742|"     OBJECTIVES: I. Compare the safety and efficacy of clostridial collagenase vs placebo in terms     of improving the degree of flexion deformity, range of finger motion, and grip strength in     patients with residual stage Dupuytren's disease.      II. Compare the overall clinical success rate, time to return to normal finger contracture to     within 0-5 degrees of normal (zero degrees), and frequency of cord rupture in the joint of     patients treated with these regimens.      III. Compare the baseline change in degree of finger flexion deformity, range of motion of     the treated finger, and strength of hand grip (in pounds) in patients treated with these     regimens.      IV. Compare the frequency distribution of the number of patients with reduction in finger     contracture to within 0-5 degrees of normal (zero degrees) and the number who require     re-treatment with open-label collagenase after treatment with these regimens.   "
166445|NCT00014755|"     OBJECTIVES: I. Determine the toxicity of total-body irradiation, anti-thymocyte globulin, and     cyclophosphamide followed by syngeneic or autologous peripheral blood stem cell (PBSC)     transplantation in patients with multiple sclerosis.      II. Determine the disease response of patients treated with this regimen. III. Determine the     safety and efficacy of filgrastim (G-CSF) for PBSC mobilization in this patient population.   "
166446|NCT00014768|"     OBJECTIVES: I. Compare the clinical status of pregnant vs non-pregnant women with cystic     fibrosis.      II. Determine glucose tolerance during each trimester of pregnancy in these women.      III. Evaluate peripheral insulin sensitivity in these women. IV. Evaluate whole body protein     turnover and hepatic glucose production in these women.      V. Determine resting energy expenditure in these women.   "
166447|NCT00014781|"     OBJECTIVES:      I. Determine the amount of hepatic glucose production derived from gluconeogenesis and     glycogenolysis in the post-absorptive state in patients with cystic fibrosis.      II. Determine de novo lipogenesis in relationship to resting energy expenditure in this     patient population.   "
166448|NCT00014794|"     This study will test whether positron emission tomography (PET) imaging can be used to     measure blood flow to joints in patients with rheumatoid arthritis (RA). It will also compare     blood flow measurements using PET with measurements obtained with magnetic resonance imaging     (MRI) to determine how useful MRI is in measuring blood flow to joints.      Much of the joint damage in RA is caused by the synovium-the lining of the joint. In RA, the     synovium increases in size and destroys bone and cartilage. The synovium maintains its growth     by forming many new small blood vessels to nourish it. New drug treatments are being     developed to stop the growth of these new blood vessels. The effect of these treatments on     the synovium is usually measured by performing a biopsy-removing a small piece of synovium     for examination under a microscope. The biopsy requires inserting a needle into the joint to     withdraw the synovial tissue. This study will see if changes in blood flow can be assessed     accurately using noninvasive imaging procedures, such as PET scanning, instead of a biopsy.      Patients 18 years of age and older with rheumatoid arthritis who have at least one tender and     swollen knee due to synovitis may be eligible for this study. Candidates will be screened     with a medical history and physical examination.      Participants will have a mold made of the knee to be studied and will have routine blood     tests. Women who are able to become pregnant will have a pregnancy test. All participants     will then undergo PET and MRI scanning as described below:      PET - A needle is used to insert a catheter (small plastic tube) into an arm vein for     injection of the radioactive substance H215O. The patient lies in a doughnut-shaped machine     (the PET scanner) and a quick scan is done to measure body thickness. Then, a separate scan     is taken following each of six or fewer injections of H215O. Each scan lasts about 13     minutes.      MRI - The patient lies on a stretcher that is moved into a cylinder containing a magnetic     field (the MRI scanner). A special coil is placed over the knee to improve the quality of the     images. Earplugs are worn to muffle the loud thumping sound produced by electrical switching     of the magnetic fields during the imaging. A contrast agent called gadolinium is injected     through a catheter into a vein to improve the quality of the images. An intercom system     permits the patient to communicate with the technician at all times during the procedure.   "
166449|NCT00014807|"     This is a community-based participatory research program focusing on pesticide contamination     in migrant farmworker families.   "
166450|NCT00014820|"     To study work-related asthma in a low-income, urban population.   "
166451|NCT00014833|"     To investigate the inverse association between socioeconomic status (SES) and cardiovascular     disease (CVD) in the Atherosclerosis Risk in Communities (ARIC) Study cohort.   "
166454|NCT00014885|"     This project studies the relationship between lead exposure and academic achievement in     college students. Most studies of the neurobehavioral effects of lead have focused on     performances at the low end of the distribution. There is evidence that lead affects outcome     across the entire distribution. This is a retrospective cohort study of subjects whose     cognitive function is adequate to gain admission to college. We will use x-ray fluorescence     to measure bone lead concentrations in undergraduate college students and test the hypothesis     that achievement scores are related to early lead exposure. Early lead exposure has been     shown to have measurable effects on academic performance and neurobehavioral outcomes at 18     years of age. Should an effect be found in this study, the spectrum of lead toxicity would be     expanded to include subjects with above average function.   "
166455|NCT00014898|"     We are examining the past exposure to lead in 250 well characterized children with ADHD, and     a suitable group of controls. Our measure of past exposure is bone lead levels obtained by     XRay fluorescence spectroscopy, a relatively new way of estimating bone lead concentrations,     and by inference, body lead burdens. By comparing the lead concentrations in these two     groups, controlling for other factors which could confound, we will estimate odds ratios for     ADHD given elevated bone lead, and estimate the contribution of lead to this disease of     childhood.   "
166456|NCT00014911|"     The purpose of this study is to test whether the islet cell transplantation procedures and     results from a previous study in Edmonton, Canada, can be repeated. The study also is     designed to learn more about diabetes control using islet cell transplantation.      This is a Phase I/II study (a study that examines effectiveness and looks for side effects).     The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood     sugar levels will not stay normal, despite intensive insulin therapy. A recent study     conducted in Edmonton, Canada, was able to demonstrate that islet transplantation led to     insulin independence in a majority of the patients treated. This study extends the results     obtained from the Edmonton study, which used islet transplantation in Type 1 diabetic     patients with steroid-free immunosuppression.   "
166457|NCT00014937|"     ACTG 388 was a clinical trial that compared three- and four-drug anti-HIV drug regimens and     demonstrated the effectiveness of a three-drug regimen. This study will compare the ability     of two different three-drug anti-HIV drug regimens to reduce levels of HIV in the blood. The     study will also evaluate whether patients discontinue the regimens because of drug side     effects.   "
166458|NCT00014950|"     Although cystic fibrosis (CF) is the most common, life-threatening autosomal recessive     genetic disorder of the white population, there are often delays in diagnosis and hence start     of treatment. Advances of the past two decades have made CF screening feasible using     routinely collected neonatal blood specimens and measuring an enzyme level followed by CF     mutation DNA analysis. Our overall goal of the study is to see if early diagnosis of CF     through neonatal screening will be medically beneficial without major risks. ''Medically     beneficial'' refers to better nutrition and/or pulmonary status, whereas '' risks'' include     laboratory errors, miscommunication or misunderstanding, and adverse psychosocial     consequences. Specific aims include assessment of the benefits, risks, costs, quality of     life, and cognitive function associated with CF neonatal screening and a better understanding     of the epidemiology of CF.      A comprehensive, randomized clinical trial emphasizing early diagnosis as the key variable     has been underway since 1985. Nutritional status has been assessed using height and weight     measurements and biochemical methods. The results have demonstrated significant benefits in     the screened (early diagnosis) group. We are now focusing on the effect of early diagnosis of     CF on pulmonary outcome. Pulmonary status is measured using chest radiographs, chest scans     using high resolution computerized tomography, and pulmonary function tests. Other factors     that we are looking at include risk factors for the acquisition of respiratory pathogens such     as Pseudomonas aeruginosa, quality of life and cognitive function of children with CF who     underwent early versus delayed diagnosis, as well as the cost effectiveness of screening and     the costs of diagnosis and treatment of CF throughout childhood.      If the questions underlying this study are answered favorably, it is likely that neonatal     screening using a combination of enzyme level (immunoreactive trypsinogen) and DNA test will     become the routine method for identifying new cases of CF not only in the State of Wisconsin,     but throughout the country.   "
166459|NCT00014963|"     This study compares air pollution exposures of residents in a South Baltimore community next     to major industry with those in a comparison community with much less industry nearby.     Parents and children as well as adults alone will be included. Air levels of 3 chemicals that     have been found in increased amounts in the community as well as two urinary breakdown     products of benzene will be measured. Participants will limit the amount of sorbate preserved     foods they eat as this preservative interferes with one of the benzene breakdown products.     Benzene air and urine exposure measurements will be compared in each community as well as     between communities. By including children and parents we will gather exposure information on     children who may be more sensitive that adults to these types of pollution. Lastly, by     restricting the amount of food preserved with sorbates, we can decide if this improves the     use of ttMA for people exposed to benzene from air pollution.   "
166460|NCT00014976|"     This study will provide information about changes that occur in the motor neurons of the     spinal cord (the nerve cells that control the muscles) when the motor cortex (the region of     the brain that controls movement) is unable to send messages to the spinal cord and muscles     in the normal way. This information will help elucidate how the nervous system adapts after     injury or disease of the motor cortex.      Healthy adult volunteers and adults with a spasticity disorder and moderate weakness may be     eligible for this study. Patients will be screened with a medical history, physical     examination and diagnostic studies as needed. Healthy volunteers will have a neurological     examination. Muscle weakness and spasticity will be evaluated in both groups of subjects.      All participants will have electromyography (measurement of electrical activity in muscles)     during nerve stimulation and transcranial magnetic stimulation, described below. (Some     patients, such as those with a pacemaker or implanted medication pumps, metal objects in the     eye, history of epilepsy and others, will not have magnetic stimulation.)      Electromyography - The electrical activity of muscles will be measured either by 1) using     metal electrodes taped to the skin overlying a muscle, or 2) using thin wires inserted into     the muscle through a needle.      Nerve stimulation - The nerves will be stimulated by applying a small electrical pulse     through metal disks on the skin of the arm or leg.      Transcranial magnetic stimulation - A brief electrical current is passed through a wire coil     placed on the scalp. This creates a magnetic pulse, which stimulates the brain. During the     test, the participant may be asked to tense certain muscles slightly or perform other simple     actions.      Nerve block - Some patients will have a nerve block of one of the nerves in the arm. For this     procedure, a local anesthetic is injected under the skin to produce numbness and weakness in     some arm muscles.   "
166461|NCT00014989|"     As many more premature infants survive, the numbers of these infants with health problems     increases. The rate of cerebral palsy (CP) in extremely premature infants is approximately     20%. Magnesium sulfate, the most commonly used drug in the US to stop premature labor, may     prevent CP. This trial tests whether magnesium sulfate given to a woman in labor with a     premature fetus (24 to 31 weeks out of 40) will reduce the rate of death or moderate to     severe CP in the children at 2 years. The children receive ultrasounds of their brains as     infants and attend three follow-up visits over two years to assess their health and     development.   "
167681|NCT00022152|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who     have stage IV breast cancer.   "
166462|NCT00015002|"     A course of steroids given to a mother who is in labor with a premature fetus will reduce the     risk of the premature infant dying or having serious complications. This trial will test     whether more than one course of antenatal steroids is more beneficial or risky to the infant     than a single course.   "
166463|NCT00015015|"     Dichloroacetate (DCA) is a product of water chlorination and a metabolite of certain     industrial solvents, thus making it a chemical of environmental concern. However, DCA is also     used as an investigational drug for treating various diseases of adults and children, at     doses far greater than those to which humans are normally exposed in the environment. Our     research involves how DCA is metabolized by healthy adults and by children with a fatal     genetic disease, congenital lactic acidosis (CLA) who are treated with DCA.   "
166464|NCT00015028|"     The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone     sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The     developmental objective for this combination product is an expansion of therapeutic options     for the treatment of opiate dependence.   "
166465|NCT00015041|"     The purpose of this study is to evaluate the effect, pharmacokinetics and dose     proportionality of buprenorphine when administered to non-dependent opiate users. 1) To     evaluate whether plasma concentrations of buprenorphine increase proportionally to     buprenorphine dose. 2) To evaluate the dose-response of subjective and physiological effects     of buprenorphine; and 3) To determine the safety of buprenorphine.   "
166466|NCT00015054|"     The purpose of this study is to demonstrate the feasibility of methylphenidate (MPD) as     effective and safe in the outpatient treatment of cocaine-dependent patients with a comorbid     DSM-IV diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), to demonstrate the     ability of each site to participate in a subsequent anticipated controlled trial of MPD     (recruitment and execution), and to gather preliminary data on the ability of sweat patches     to detect episodes of cocaine use.   "
166467|NCT00015067|"     The purpose of this study is to attempt to identify possible dangerous interactions between     cocaine and methylphenidate (MPD). Additional objectives are to determine: a) if MPD reduces     the craving and high for cocaine; b) if there are pharmacokinetic and pharmacodynamic     interactions between cocaine and MPD; and c) the relationship between cocaine and     benzoylecgonine (BE) levels in plasma and BE levels in urine.   "
166468|NCT00015080|"     The purpose of this study is to determine the efficacy of naltrexone in the treatment of     cocaine dependence as measured by: 1) decreased urine benzoylecgonine (BE) levels, 2)     decreased cocaine use by self-report, 3) decreased cocaine craving, and 4) retention in     treatment.   "
166469|NCT00015106|"     The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the treatment     of cocaine dependence using reserpine, gabapentin, or lamotrigine vs. an unmatched placebo     control.   "
166470|NCT00015132|"     The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the use of     tiagabine, sertraline, or donepezil for the treatment of cocaine dependence using a modified     placebo-controlled experimental design.   "
166471|NCT00015171|"     The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid     dependence.   "
166472|NCT00015210|"     The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and     depression comorbidity.   "
166473|NCT00015223|"     The purpose of this study is the use of Methylphenidate in the treatment of cocaine     dependence and Attention Deficit Hyperactivity Disorder (ADHD) comorbidity.   "
166474|NCT00015236|"     The purpose of this study is for the modeling of impaired judgement in cocaine abusers.   "
166475|NCT00015249|"     The purpose of this study is to assess the effects of chronic cocaine use on the acoustic     startle response and on gating of this response in humans.   "
166476|NCT00015275|"     The purpose of this study is to define pathophysiological subtypes of abnormalities in     subjects with cocaine dependence.   "
166477|NCT00015288|"     The purpose of this study is to examine pharmacokinetics and dose proportionality of     sublingual tablets containing varying doses of buprenorphine and naloxone.   "
166478|NCT00015301|"     The purpose of this study is to evaluate PET methodology to study in vivo synaptic dopamine     release.   "
166479|NCT00015340|"     The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the     treatment of opioid dependence. A compassionate use study.   "
166480|NCT00015431|"     This study will determine whether people with common variable immunodeficiency (CVID) with     and without gastrointestinal (GI) symptoms have gut abnormalities (inflammation or loss of     function) and changes in immune system cells and chemicals in the blood and gut. People with     CVID have decreased levels of serum immunoglobulin IgG and IgA. Patients have sinus, lung and     other infections, and many also have stomach and intestinal problems, such as chronic     diarrhea, inability to absorb nutrition from food, and intestinal infections caused by     bacteria.      CVID patients with gastrointestinal symptoms 10 years of age and older may be eligible for     this study; CVID patients without gastrointestinal symptoms 18 years of age and older will be     enrolled as control subjects. Candidates will be screened with a review of their medical     records, a medical history and physical examination, HIV blood test, stool sample, and     hydrogen breath test. The breath test measures the amount of hydrogen in the breath after     drinking sugar water, showing the digestive effects of bacteria in the upper intestine.      Participants will be admitted to the NIH Clinical Center for several days to undergo the     following procedures:        -  Medical history and physical examination        -  Blood tests        -  Urine and stool samples        -  48-hour stool fat collection measures the amount of undigested fat in the stool to          determine the ability of the gut to digest and absorb fat in the diet        -  D-Xylose absorption test measures the ability of a sugar compound to travel across the          lining of the intestine to determine the ability of the gut to absorb nutrients        -  Upper endoscopy a thin flexible lighted tube is advanced through the mouth to evaluate          the esophagus, stomach and beginning of the small intestine        -  Lower endoscopy a thin lighted tube is advanced through the rectum to evaluate the colon      Identification of GI abnormalities associated with changes in immune response in CVID     patients will help in developing and testing new treatments for this disease.   "
166490|NCT00015613|"     The most persistent and intractable cause of infant and child mortality and morbidity in the     US remains preterm and low birthweight deliveries. Pregnant women in the United States     experience the highest incidence of these complications among developed countries. Even more     disturbing is the observation that immigrant Hispanic women experience worsening birth     outcomes the longer they live here, despite increasing access to prenatal care, improved     socio-economic status and better education. The purpose of this study is to identify the     potential acculturation-related risk factors for preterm and low birthweight (PTLBW) delivery     among Hispanic women of varying lengths of US residency. It is hypothesized that changes in     factors associated with acculturation, such as poor nutritional intake, job stress and     occupational exposures to pesticides or other hazards, and certain types of genital     infections, can best explain the worsening of pregnancy outcomes among Hispanic immigrant     women.   "
166491|NCT00015626|"     The goal of this study is to aggressively treat insulin resistance and its clinical     manifestations when they first appear in childhood, and to prevent the subsequent progression     towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical     trial, we will learn more about the early manifestations of insulin resistance, its     treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and     in-vitro studies.   "
166780|NCT00019539|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them.      PURPOSE: Randomized phase II trial to determine the effectiveness of monoclonal antibody     therapy in treating patients who have advanced kidney cancer that cannot be surgically     removed.   "
166481|NCT00015444|"     Objective:      The objectives of this protocol are:      to develop and maintain a repository of clinically characterized patients with primary     lateral sclerosis for future research protocols,      to characterize the natural history of neurodegenerative disorders with corticospinal neuron     degeneration,      to investigate proposed etiologies, risk factors, and biomarkers for the development of these     disorders and for disease progression      Study Population:      240 patients with adult-onset progressive spasticity with a diagnosis of primary lateral     sclerosis or related upper motor neuron disorder      Design:      Patients who have been referred by physicians for primary lateral sclerosis will undergo a     screening evaluation at the first visit. The screening visit will include review of outside     medical records, neurological examination, and diagnostic testing to determine possible     causes of spasticity. Patients fulfilling the clinical criteria for primary lateral sclerosis     by history or examination will be followed to determine the natural history of this disorder.     Measures of motor and cognitive function will be made at baseline and follow-up visits to     follow clinical progression. Magnetic resonance imaging will be carried out to determine if     imaging changes occur over time. Patients identified in this protocol who are eligible for     other research protocols will be invited to participate in additional protocols.      Outcome Measures:      Clinical progression will be documented by measures of finger-tapping, timed gait, speech.     The association between clinical progression and MRI measures will be assessed as a secondary     outcome.   "
166482|NCT00015457|"     Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of     botulinum toxin injections in the treatment of focal dystonia.      Study Population: 20 patients with cervical dystonia      Design: Double-bind, placebo-controlled clinical trail.      Outcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale,     NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers:     Amplitude of EDB MEP.   "
166483|NCT00015470|"     The objectives of this protocol are to: 1) screen patients with various neuromuscular     disorders and facilitate their entry into appropriate research protocols; 2) help resolve     puzzling diagnostic neuromuscular problems and train fellows in the evaluation and treatment     of Neuromuscular Diseases; and 3) provide follow up to patients who finished their     participation in a previous study but they are not currently entered in another research     protocol. No investigational treatments will be performed on this protocol but the tissues     collected can be used for future research studies.   "
166484|NCT00015483|"     Hematotoxicity is caused by a number of agents such as a benzene by-product called     hydroquinone and the antitumor agent doxorubicin. This is a basic research study, conducted     using normal human donors, of mechanisms involved in hematotoxicity and of the protective     response of human hematopoietic progenitor cells to hematotoxic agents. Tumor necrosis factor     exposure protects these cells from a subsequent exposure to hematotoxic agents. The     alteration of gene expression in these cells caused by tumor necrosis factor is being     studied. Additionally, the tumor necrosis factor-induced biochemical pathways involved in     protection of human hematopoietic progenitor cells will be studied.   "
166485|NCT00015548|"     The CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of     Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease     who are having trouble with their thinking or behavior. In particular, this study is trying     to find out the best treatment for people who have hallucinations (seeing or hearing things     that aren't there), delusions (false beliefs), or agitation. The design of the trial helps to     increase the chance that participants in the study receive a medication that helps them. The     study uses three medications known as atypical antipsychotics (olanzapine, quetiapine,     risperidone), which are the newest medications that are currently available for treating     these problems. Participants may also receive an antidepressant (citalopram). The trial lasts     for 36 weeks. Participants are given a thorough evaluation at no cost to ensure that this     study is appropriate. In addition, the caregiver, family member, or friend who comes with the     participant will be offered an educational program about Alzheimer's disease.   "
166486|NCT00015561|"     This project is designed to establish whether pesticides or other environmental agents have a     role in the excess birth defects identified in the Red River Valley of Minnesota. In this     human study, laboratory based health parameters will be used to key in health survey data. In     vitro data will be developed to mechanistic information. Concordant results among these study     features will provide a weight of evidence approach.   "
166487|NCT00015574|"     Community based studies have shown increased cardiovascular mortality associated with acute     exposures to particulate air pollution. Electrocardiographic changes have also been reported     in animals exposed to particles in controlled conditions. We have hypothesized that     cardiovascular patients may experience life-threatening arrhythmias associated with     particulate air pollution episodes. Implanted cardioverter defibrillator (ICD) devices     continuously monitor the heart rhythm, and on detecting arrhythmias can initiate     interventions. These devices provide a passive, continuous monitor of cardiac arrhythmias. We     are assessing the association between community exposures to air pollution measured by     ambient monitors and these cardiac arrhythmias detected by implanted cardioverter     defibrillator devices.   "
166488|NCT00015587|"     This study is a case-control study investigating the causes of childhood leukemia in Northern     California. The overall purpose of this epidemiologic study is to find specific genetic or     environmental factors that may increase the risk of leukemia in children. The study is being     conducted by Patricia Buffler, PhD at the School of Public Health - University of California     Berkeley in collaboration with the California Department of Health Services and 16 hospitals     located throughout the state of California. The study began in 1995 and will continue to     2014.   "
166489|NCT00015600|"     This community-based project, called the Together for Agricultural Safety project, was     developed to help farmworkers reduce their exposure to dangerous agricultural chemicals (such     as pesticides) through education and social marketing. The project is a partnership of     university researchers and the Farmworkers Association of Florida. After collecting extensive     data from farmworkers, health providers and farm owners about primary means of pesticide     exposure we are collaboratively developing an intervention that will reduce pesticide     exposure by educating workers and owners about: the need to have adequate washing facilities;     to wash hands frequently; to obey reentry intervals; to change work clothes after work to     prevent child exposure and more.   "
166492|NCT00015639|"     Plasma histidine-rich glycoprotein (HRG) binds to platelets in the presence of zinc (1). This     binding is totally blocked by a monoclonal antibody directed against platelet membrane CD36.     Therefore, CD36 is assumed to carry the platelet binding site for HRG (2). Because CD36 also     has a variety of other ligands, including polyanionic lipids, it is also possible that it     contains the binding site for heparin (also polyanionic) and might be involve in the     pathogenesis of heparin-induced thrombocytopenia. Demonstrating absent HRG or heparin binding     to platelets lacking CD36 would confirm that the binding sites for either or both of these     ligands are located on this membrane protein. Because 3% to 11% of healthy Japanese are     reported to lack CD36 on their platelets, this population is a practical source of cells for     examining the physiologic role(s) for CD36. Therefore, we will recruit blood donors from the     Japanese community on the NIH campus. Their platelets will tested for the presence of CD36.     Recruitment will be closed after two individuals have been identified whose platelets lack     CD36 and who are willing to donate 30 cc of blood on 4 or 5 subsequent occasions for binding     studies with radiolabeled HRG and heparin.   "
166493|NCT00015652|"     This study will test the safety and effectiveness of a new treatment for hepatitis C (HCV) in     patients who also have HIV.      The usual treatment for HCV in people who are not HIV-infected is interferon-alfa (IFN) with     ribavirin (RBV), an approved treatment by the Food and Drug Administration (FDA). This study     will use a new, longer acting form of IFN called PEG-IFN alfa-2b. PEG-IFN alfa-2b is approved     by the FDA for use in treating HCV but has not yet been approved for use with RBV. This study     also will use IL-2, which is a substance that the body naturally produces. People with HIV     infection usually do not make enough IL-2. IL-2 is being tested in this study to see if it     will boost the immune system's response to HCV. The FDA has approved IL-2 for the treatment     of some cancers.   "
166494|NCT00015665|"     This protocol provides for emergency treatment with the experimental anti-fungal drug     voriconazole for patients with life-threatening invasive fungal infections. The increase in     the number of patients whose immune function is suppressed because of chemotherapy, tissue or     organ transplantation, or HIV infection has led to an increase in fungal infections. New     drugs are needed to combat these infections in patients who do not respond to or cannot     tolerate standard treatments.      Patients on other primary NIH protocols who have an invasive life-threatening fungal     infection that does not respond to currently available treatments or who cannot tolerate     these treatments may be eligible for this study.      Participants will have a blood test and a physical examination before receiving voriconazole.     They will receive voriconazole twice a day either as an infusion into a vein or as tablets     taken by mouth. Adult patients will be asked to provide a blood sample any time after the     first dose of voriconazole to be used for developing a test to measure voriconazole     concentration in the blood. Patients will be evaluated about 10 days after starting treatment     and then at least once every 4 weeks with a symptom check and blood test.   "
166495|NCT00015678|"     This study will investigate the effects of the drug flumazenil on brain excitability and the     drug's relationship to a natural brain chemical called GABA. Flumazenil is commonly used in     hospitals to reverse the effects of a group of drugs called benzodiazepines, one of which is     Valium. Benzodiazepines act by enhancing the effects of GABA.      Healthy volunteers 21 years of age and older may be eligible for this study. Candidates will     be screened with a medical history and physical and neurological examinations.      Participants will have transcranial magnetic stimulation (TMS) four times on two different     days, before and after receiving an intravenous (through a vein) infusion of either     flumazenil or placebo (an inactive sugar solution), as follows:      TMS study 1      Drug or placebo infusion      TMS study 2 - 15 minutes after infusion      TMS study 3 - 60 minutes after infusion      TMS study 4 - 120 minutes after infusion      In transcranial magnetic stimulation, a very brief electrical current is passed through an     insulated coil wire placed on the scalp. These currents stimulate the cortex (outer part of     the brain). They may cause muscle, hand, or arm twitching if the coil is near the part of the     brain that controls movement, or they may affect other reflexes or movements. During the     study, subjects may be asked to make movements, do simple tasks or tense muscles. To record     the electrical activity of muscles, electrodes will be taped to the skin over the muscles     tested. In some cases, the studies will be videotaped.      Flumazenil will be infused through a catheter (thin plastic tube) attached to a needle placed     in an arm vein. On one day, subjects will receive a 1-mg injection of flumazenil followed by     a continuous infusion of 0.5 mg of the drug for about 30 minutes. On the other day, they will     receive placebo, administered in the same manner.   "
166496|NCT00015691|"     The purpose of this study is to see whether metformin alone, rosiglitazone alone, or     metformin and rosiglitazone together will lower insulin levels in the blood and decrease fat     in the abdomen or other parts of the body.      Studies have shown that certain anti-HIV medications can cause a number of side effects,     including high blood sugar (resulting from the body's failure to use insulin), high insulin,     and excess fat build-up in the abdominal area. These side effects are known to increase the     risk of heart disease. Metformin and rosiglitazone are 2 drugs that have been shown to lower     insulin resistance and lessen abdominal fat in patients who are not HIV-infected. This study     will investigate the use of these drugs in HIV-infected patients.   "
166497|NCT00015704|"     Interleukin-2 (IL-2) helps the body make infection-fighting white blood cells, including CD4     and CD8 T cells. One HIV treatment strategy is planned treatment interruption (stopping     anti-HIV drugs when CD4 count and level of virus in the blood are at certain levels). The     purpose of this study is to see if IL-2 used with potent anti-HIV drugs allows for longer HIV     treatment interruptions.   "
166514|NCT00015951|"     RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Combining     monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic     cancer.      PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine     and mitoxantrone in treating patients who have hematologic cancer.   "
166515|NCT00015964|"     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells     and slow the growth of head and neck cancer.      PURPOSE: Phase II trial to study the effectiveness of ZD1839 in treating patients who have     metastatic or recurrent cancer of the head and neck.   "
168006|NCT00038662|"     The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study     is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as     measured by rate of rise in the PSA (primary objective).   "
166518|NCT00016016|"     Phase II trial to study the effectiveness of combining flavopiridol and cytarabine with     mitoxantrone in treating patients who have acute leukemia. Drugs used in chemotherapy work in     different ways to stop cancer cells from dividing so they stop growing or die. Combining more     than one drug may kill more cancer cells.   "
166498|NCT00015717|"     This study will use magnetic resonance imaging (MRI) to determine if silent strokes occur     during angioplasty of the blood vessels in the neck or skull. Neck and skull angioplasties     are relatively new procedures whose possible complications are still under investigation.      Patients 18 years of age or older who are admitted to Suburban Hospital in Bethesda,     Maryland, for angioplasty of one or more of the blood vessels in the neck or skull may     participate in this study. Participants must be able to undergo a brain MRI. Within 24 hours     before their angioplasty, patients will provide a medical history and have a physical     examination and brain MRI. The physical examination and MRI will be repeated within 24 hours     after the angioplasty.      MRI is a diagnostic test that uses a magnetic field and radio waves to show structural and     chemical changes in tissues. This technique is more sensitive than X-rays in detecting some     changes that occur in diseases of the brain. For the procedure, the patient lies on a table     that slides into a metal cylinder (the scanner). The confined space may produce anxiety in     some patients, and patients can talk to the technician at all times during the procedure.     Earplugs are provided to muffle loud knocking and pulsing noises that occur while the scanner     is taking pictures. During the study, the contrast material gadolinium may be injected into     an arm vein. Gadolinium brightens the pictures, producing better images of brain blood     flow.      Patients will be contacted by telephone 30 days after the procedure to follow how they are     doing and learn whether any complications resulted from the angioplasty.   "
166499|NCT00015756|"     This study will examine the relationship between bacterial products in lung infections in     cystic fibrosis and disease severity. It will examine plasma and lung tissue from cystic     fibrosis patients.      Patients with cystic fibrosis and having certain genetic characteristics, who are between 9     and 65 years of age and any cystic fibrosis patient undergoing lung transplantation at INOVA     Fairfax Hospital in Fairfax, Virginia, may be eligible for this study.      Patients who cannot undergo apheresis may be asked to provide up to an additional 100 cc (7     tablespoons) of blood for research to look at bacterial products.      Lung specimens of participating transplant patients will be collected at INOVA Fairfax     Hospital. Patients who participate in the apheresis portion of the study will be admitted to     the NIH Clinical Center for 2 to 3 days. Apheresis is a procedure for collecting large     quantities of specific blood components. For this study, plasma-the liquid part of the     blood-will be collected. For the procedure, whole blood is collected through a needle in an     arm vein, similar to donating blood. The blood is separated into its components by     centrifugation (spinning), the plasma and white cells are extracted and collected in a bag,     and the red cells are returned to the body, either through the same needle or through another     needle in the other arm.      During the hospital stay, patients may also be asked to participate in other cystic fibrosis     studies involving blood tests, an echocardiogram (ultrasound test of the heart), urine     pregnancy test, and pulmonary function (breathing) tests.   "
166500|NCT00015769|"     This study will explore the possible effectiveness of levetiracetam in patients with bipolar     illness who have not responded adequately to standard treatments. Levetiracetam was recently     approved to treat seizures. Other drugs in the same class as levetiracetam, including     carbamazepine and valproate, are widely recognized as substitute medications for lithium or     are used as an adjunct to it, and other anticonvulsants have also shown promise in improving     bipolar symptoms.      Patients with bipolar illness whose manic, depressed or unstable moods are not adequately     controlled by their current treatment and who have not responded previously to two standard     treatments (i.e., lithium, valproate, carbamazepine or neuroleptics) may be eligible for this     study.      Participants will take levetiracetam starting at 500 mg daily. If this dose is well     tolerated, it will be increased to 500 mg twice a day. Every 3 days, doses may be increased     until the target dose of 3000 mg/day is reached. Higher doses, not to exceed 4000 mg/day, may     be tried in patients who do not respond fully to the lower doses. Patients and observers will     use standard ratings to evaluate the patients' response to therapy during the 8-week study.     If, after 8 weeks, the results appear promising, patients may continue treatment for an     additional 6 months to evaluate longer-term effects.   "
166501|NCT00015782|"     Mucolipidosis Type IV (ML-IV) is a metabolic disorder that causes mental and motor     retardation as well as visual impairment. There is storage of material in practically all the     cells of the body, causing problems in the brain and the eyes. The disease is caused by a     defect in a gene that makes a protein called mucolipin. Patients with ML-IV do not make     enough normal mucolipin.      More than 80 patients have been diagnosed, most of whom are Ashkenazi Jews. The disease often     appears in the first year of life as either delayed motor development or corneal clouding.     There are conflicting reports concerning the progressive nature of the disease. Some patients     have clear deterioration, while others seem to stay at the same level of the disease for a     long time. This study may lead to a better understanding of the disease, the medical     difficulties of patients, and better ways of diagnosing ML-IV.      Patients with a definite diagnosis of this disease, as well as those patients who need     confirmation of the disease, are candidates for this study. Patients will be admitted     annually to the Clinical Center for a maximum of five days. A history will be taken and a     physical exam done. Blood and urine tests will be done along with brain wave recording,     complete eye examination, psychological tests, and speech and language and rehabilitation     evaluations. A maximum of 3 mL/kg of blood will be drawn from children and a total of 60 mL     from adults. Various eye tests will also be done, some under sedation. DNA will be extracted     for possible use in other studies. A skin biopsy will be taken on the first visit.      There is a possibility of improved medical management and rehabilitative treatment as a     result of participating in this study.   "
166516|NCT00015977|"     RATIONALE: Vaccines made from a patient's white blood cells may make the body build an immune     response to kill cancer cells. Interleukin-12 may kill cancer cells by stopping blood flow to     the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining     vaccine therapy with interleukin-12 may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy combined with     interleukin-12 in treating patients who have metastatic prostate cancer that has not     responded to hormone therapy.   "
166517|NCT00015990|"     Phase II trial to study the effectiveness of thalidomide in treating patients who have     myelodysplastic syndrome. Thalidomide may improve the immune system's ability to fight     myelodysplastic syndrome   "
182992|NCT00237887|"     A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects     with Moderate to Severe Chronic Plaque Psoriasis   "
166502|NCT00015795|"     This study will investigate and compare the air stream during voice production in patients     with abductor spasmodic dysphonia and in normal volunteers. People with abductor spasmodic     dysphonia have uncontrolled muscle spasms during speech, resulting in a weak voice. A better     understanding of the abnormalities of this disorder may help in the development of more     effective treatments.      Healthy volunteers and patients with abductor spasmodic dysphonia may be eligible for this     study. Candidates will have a physical examination and medical history. (Patients will be     videotaped and voice-recorded during the medical interview for review by specialists who will     identify the type and severity of their speech disorder.) All candidates will also undergo a     procedure called flexible fiberoptic laryngoscopy to record the movement of the vocal folds     during speech, breathing and other tasks such as singing, whistling and prolonging vowels.     For this test, the inside of the nose is sprayed with an anesthetic (lidocaine) to numb the     nasal cavity and a decongestant (oxymetazoline) to widen the nasal passage. Then, a thin     flexible tube called a nasolaryngoscope is passed through the nose to the larynx (voice box).     A camera attached to the eyepiece of the nasolaryngoscope records the movements of the vocal     folds.      Participants will then have an airway interruption test to detect pressure changes in the     voice box during production of continuous sounds. A nose clip is placed over the subject's     nose and two sensor devices are placed on the neck to pick up changes in movement and     position of the vocal cords during voicing. A mouthpiece is placed in the mouth, and subjects     are asked to say ah continuously at a specified sound level. This voicing is repeated 33     times with periodic breaks.      Patients only will also be given an injection of botulinum toxin. These injections are     effective, in varying degrees, in about 60 percent of patients with abductor spasmodic     dysphonia. This study will use a different approach to botulinum toxin injections to test     their effect in patients with pressures higher than normal. Rather than inject the posterior     cricoarytenoid muscle or the cricothyroid muscle, as is typically done, the thyroarytenoid     muscle, which closes the voice box, will be injected on one side. A second one-sided     injection may be given after 2 or 3 weeks if no effect is seen after the first injection.     Speech will be recorded at each visit to measure any change in symptoms after the injection.   "
166503|NCT00015808|"     This study will determine the highest dose of idebonone that can safely be given to patients     with Friedrich's ataxia, an inherited degenerative disease that causes loss of muscle     coordination, speech problems, weakness and sensory loss. Enlargement of the left ventricle     (the large pumping chamber of the heart) is also common in this disease. In studies in France     and Canada, patients with Friedrich's ataxia who were given idebonone, an antioxidant similar     to the dietary supplement coenzyme Q, had a decrease in the size of their left ventricle.      Patients 5 years and older with Friedrich's ataxia may be eligible for this study. Pregnant     and lactating women may not participate. Candidates will be screened with a medical history     and physical examination and a review of genetic studies. Patients who have not had genetic     studies will be offered genetic counseling and testing to confirm or rule out Friedrich's     ataxia.      Participants will be admitted to the NIH Clinical Center for 3 days. They will have blood and     urine tests and a heart evaluation, including an echocardiogram-a procedure that uses sound     waves to produce images of the heart, and an electrocardiogram-a study of the electrical     activity of the heart. When these tests have been completed, patients will take an idebonone     capsule. They will be monitored for side effects for 72 hours. Blood samples will be     collected through an intravenous catheter (flexible plastic tube placed in a vein) 0.5, 1, 2,     3, 4, 6, 12, 24, 48 and 72 hours after the drug is taken to determine how long it takes for     the drug to be eliminated from the body.      Patients will return for a follow-up visit within 1 to 8 weeks. Those who experienced no     serious side effects may receive another, higher dose of the drug, with at least 6 days     between doses.   "
166504|NCT00015821|"     Phase II trial to study the effectiveness of thalidomide in treating patients who have     myelofibrosis. Thalidomide may stop the growth of myelofibrosis by stopping blood flow to the     cancer cells.   "
166505|NCT00015834|"     Phase I/II trial to study the effectiveness of combining STI571 and chemotherapy in treating     patients who have chronic myelogenous leukemia. Drugs used in chemotherapy use different ways     to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of     leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells   "
166506|NCT00015847|"     RATIONALE: Imatinib mesylate and interferon alfa may interfere with the growth of the cancer     cells. Combining imatinib mesylate with interferon alfa may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining imatinib mesylate with     interferon alfa in treating patients who have chronic myelogenous leukemia.   "
166507|NCT00015860|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining     chemotherapy and STI571 may kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus STI571     in treating patients who have chronic myelogenous leukemia or acute lymphocytic leukemia.   "
166508|NCT00015873|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known which combination chemotherapy regimen is most effective for treating infants     with acute lymphoblastic leukemia.      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination     chemotherapy regimens in treating infants who have newly diagnosed acute lymphoblastic     leukemia.   "
166509|NCT00015886|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     women who have breast cancer that is metastatic or cannot be treated with surgery.   "
166510|NCT00015899|"     RATIONALE: SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for     cancer cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of SCH 66336 in     treating children with recurrent or progressive brain tumors.   "
166511|NCT00015912|"     Phase II trial to study the effectiveness of combining thalidomide with interferon alfa in     treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Thalidomide may     stop the growth of cancer by stopping blood flow to the tumor. Interferon alfa may interfere     with the growth of cancer cells. Combining thalidomide with interferon alfa may kill more     tumor cells   "
166512|NCT00015925|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of MS-275 in treating patients who have     hematologic cancer.   "
166513|NCT00015938|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel, vinorelbine, and     filgrastim in treating women who have stage IV breast cancer.   "
166519|NCT00016029|"     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective     treatment for cancer. New diagnostic procedures such as computed tomographic colonography may     provide a less invasive method of identifying patients who have colon cancer.      PURPOSE: Diagnostic and screening trial to compare the effectiveness of barium enema,     computed tomographic colonography, and colonoscopy in detecting of colon cancer.   "
166520|NCT00016042|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Biological therapies use different ways to stimulate the immune     system and stop cancer cells from growing. Combining chemotherapy with biological therapy may     kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of fluorouracil combined with biological     therapy in treating patients who have metastatic kidney or colorectal cancer.   "
166521|NCT00016055|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die. Combining biological therapy with chemotherapy may     kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of biological therapy combined with     temozolomide in treating patients who have metastatic melanoma.   "
166522|NCT00016068|"     RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in     preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing     cytomegalovirus.      PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works     in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation.   "
166523|NCT00016081|"     RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is     not yet known if ribavirin is more effective than standard therapy in preventing pneumonia in     patients who have respiratory syncytial virus (RSV) infection following stem cell     transplantation.      PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with that of     standard therapy in preventing pneumonia in patients who have RSV infection following stem     cell transplantation.   "
166524|NCT00016094|"     Phase II trial to study the effectiveness of bevacizumab in treating patients who have     non-Hodgkin's lymphoma. Monoclonal antibodies such as bevacizumab may stop the growth of     cancer by stopping blood flow to the tumor. Bevacizumab may be an effective treatment for     non-Hodgkin's lymphoma   "
166525|NCT00016107|"     Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal     antibody therapy in treating patients who have metastatic prostate cancer that has not     responded to previous hormone therapy. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as     bevacizumab may stop the growth of cancer cells by stopping blood flow to the tumor.     Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.   "
166526|NCT00016133|"     RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body     build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways     to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with     chemotherapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy combined with     leucovorin and fluorouracil in treating patients who have undergone surgery to completely     remove stage II or stage III colon cancer.   "
166527|NCT00016146|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Biological therapies use different ways to stimulate the immune system and stop cancer cells     from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness in combining vaccine therapy and biological     therapy in treating patients who have relapsed prostate cancer.   "
166528|NCT00016159|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Combining     monoclonal antibody therapy with chemotherapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and monoclonal     antibody in treating patients who have acute promyelocytic leukemia.   "
166529|NCT00016172|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of combining ZD0473 and doxorubicin in     treating patients who have advanced solid tumors or lymphoma.   "
166530|NCT00016185|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol and docetaxel in     treating patients who have advanced solid tumors.   "
166531|NCT00016198|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and     leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic     colorectal cancer.   "
166532|NCT00016211|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy     to the brain may be effective in preventing brain metastases. It is not yet known if     radiation therapy is effective following chemotherapy in preventing brain metastases.      PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in     preventing brain metastases in patients who have received chemotherapy for extensive-stage     small cell lung cancer.   "
166533|NCT00016224|"     RATIONALE: Drugs such as thalidomide may stop the growth of cancer cells by stopping blood     flow to the tumor.      PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating women who have     epithelial ovarian cancer that has not responded to previous therapy.   "
166779|NCT00019513|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine, fluorouracil, and     leucovorin in treating patients with recurrent, refractory, or metastatic solid tumors or     lymphomas.   "
166534|NCT00016237|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.     Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing     substances to them without harming normal cells. Interleukin-2 combined with a monoclonal     antibody may be an effective treatment for kidney, bladder, or lung cancer.      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 combined with a monoclonal     antibody in treating patients who have kidney, bladder, or lung cancer that has not responded     to previous treatment.   "
166535|NCT00016250|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of     Ro 31-7453 in treating patients who have recurrent or refractory metastatic colorectal     cancer.   "
166536|NCT00016263|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Oblimersen (G3139) may help dacarbazine kill more cancer cells by     making tumor cells more sensitive to the drug. It is not yet known if dacarbazine is more     effective with or without oblimersen (G3139).      PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or     without oblimersen (G3139) in treating patients who have advanced malignant melanoma.   "
166537|NCT00016276|"     Randomized phase III trial to compare the effectiveness of combination chemotherapy, surgery,     and radiation therapy with or without dexrazoxane and trastuzumab in treating women who have     stage IIIA, stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different     ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs,     such as dexrazoxane, may protect normal cells from the side effects of chemotherapy.     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses     high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy combined with     surgery and radiation therapy is more effective with or without dexrazoxane and trastuzumab     in treating breast cancer   "
166538|NCT00016289|"     Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating     patients who have ovarian epithelial cancer or primary peritoneal cancer. Interleukin-12 may     kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white     blood cells to kill tumor cells. Giving interleukin-12 directly into the peritoneal cavity     may kill cancer cells   "
166539|NCT00016302|"     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Combining more than one drug may kill more cancer cells. This phase II trial     is studying several different combination chemotherapy regimens to see how well they work in     treating patients with newly diagnosed acute lymphoblastic leukemia   "
166540|NCT00016315|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, work     in different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with     chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining combination chemotherapy with     radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung     cancer.   "
166541|NCT00016328|"     Phase II trial to study the effectiveness of CCI-779 in treating patients who have recurrent     glioblastoma multiforme. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die.   "
166542|NCT00016341|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Estrogen can stimulate the growth of tumor cells. Hormone therapy     using tamoxifen and megestrol may fight endometrial cancer by blocking the absorption of     estrogen. It is not yet known whether chemotherapy is more effective than hormone therapy in     treating endometrial cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with that of hormone therapy in treating patients who have recurrent, stage III, or stage IV     endometrial cancer.   "
166543|NCT00016354|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of benzoylphenylurea in treating patients     who have advanced solid tumors.   "
166544|NCT00016367|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.      PURPOSE: Phase II trial to study effectiveness of combining cisplatin, gemcitabine, and     trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer.   "
166545|NCT00016380|"     RATIONALE: Antiemetic drugs may help to reduce or prevent vomiting in patients treated with     radiation therapy. It is not yet known if ondansetron is more effective with or without     dexamethasone in preventing vomiting caused by radiation therapy.      PURPOSE: This randomized phase III trial is comparing how well ondansetron works with or     without dexamethasone in preventing vomiting in patients with cancer who are receiving     radiation therapy to the upper abdomen.   "
166546|NCT00016393|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who     have prostate cancer that has not responded to hormone therapy.   "
166547|NCT00016406|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether combination chemotherapy is more     effective with or without filgrastim in treating breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combining doxorubicin,     cyclophosphamide, and paclitaxel with or without filgrastim in treating women who have     inflammatory or locally advanced breast cancer.   "
166548|NCT00016419|"     RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be an     effective treatment for myelodysplastic syndrome.      PURPOSE: Phase II trial to study the effectiveness of antithymocyte globulin plus     cyclosporine in treating patients who have myelodysplastic syndrome.   "
182993|NCT00237900|"     To assess safety, efficacy and explorative objectives of gefitinib in combination with     chemoradiation in resectable gastric cancer   "
166549|NCT00016432|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells.     It is not yet known whether exemestane is effective in preventing the recurrence of breast     cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing     cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA     breast cancer and have completed 5 years of tamoxifen.   "
166550|NCT00016445|"     OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body     weight, and lean body mass in patients with cystic fibrosis.      II. Determine the effect of growth hormone on pulmonary function in these patients.      III. Determine the impact of this drug on the quality of life in these patients.      IV. Determine if the clinical response from this drug is sustained in these patients.   "
166551|NCT00016458|"     OBJECTIVES: I. Determine the toxicity of cyclophosphamide and rabbit anti-thymocyte globulin     in patients with diffuse systemic sclerosis.      II. Determine the efficacy of this regimen in terms of controlling disease in these patients.   "
166552|NCT00016471|"     Hearing loss and loss of vision can be very harmful to the well-being and life of people who     suffer from them. Usher syndrome is the name of a disease where people have both hearing loss     and visual loss. In fact more than half of people who are deaf and blind have Usher syndrome.     In this study we are trying to find the causes of all types of Usher syndrome and to learn     more about how the eyes and ears work. Usher syndrome is caused by changes in our genes that     lead to mistakes in the functioning of our eyes and ears.      We may conduct hearing tests called audiograms to test hearing and a vision test called an     electroretinogram (ERG) to test how well the retina (the part of your eye that senses light)     is working on participants in the study. From these tests we can tell what kind of Usher     syndrome a participant may have.      We will then get DNA from participants by drawing blood. The DNA will be studied, along with     DNA from members of the participant's family and other families, to try to find the gene that     is causing Usher syndrome in the participant.      Once the gene is found we will be able to study it to learn more about how the eyes and ears     work.      If a subject has already been diagnosed we may just need copies of their medical records and     blood can be drawn locally.      In order to increase the power of the study and the likelihood of detecting relevant genes     participants will be taken from the Ashkenazi Jewish population group only. This will make it     much easier to find the genes.   "
166553|NCT00016497|"     The purpose of this study is to evaluate the efficacy of three different surgical treatments     (1. Bilateral myringotomy and tube insertion (M&T); 2. Adenoidectomy and bilateral     myringotomy (A&T); 3. Adenoidectomy with myringotomy and tympanostomy tube insertion (A-M&T))     in reducing subsequent episodes of middle ear disease and hearing loss caused by the fluid in     the middle ear in children aged 24-47 months. The fluid in the middle ear is of at least     three months' duration and unresponsive to standardized, recent antimicrobial treatment. The     children are assigned to one of the three surgical treatments. After surgery, they are     followed with examinations monthly and at the time of intercurrent infections for three     years.   "
166554|NCT00016510|"     This study will examine differences in how the brain processes English and Korean in native     Korean speakers who are fluent and non-fluent in English as a second language. It is thought     that people who are non-fluent in a second language process the second language differently     from their native language-using different areas of the brain and requiring additional     working memory. The study will increase understanding of language acquisition, brain     plasticity and bilingualism.      Native Korean speakers between 18 and 50 years of age with English as a second language may     be eligible for this study. Three groups of individuals will be enrolled: 1) less fluent     bilinguals - those who have lived in the United States for at least 1, but less than 2 years     and studied English after age 12 and who have a TOEFL (Test of English as a Foreign Language)     score above 550; 2) fluent bilinguals with early acquisition - those who were exposed to     English before age 7 and lived in the United States after that; and 3) fluent bilinguals with     late acquisition - those who were exposed to English after age 12 and lived in the United     States after age 10. People with a history of head injury or neurological or thought     disorder, left-handed people, and people who cannot read the material used in the study will     be excluded from the study.      Participants will undergo magnetic resonance imaging (MRI) scanning while reading words in     English or Korean; while translating from one language to the other; and while answering     questions about the meaning of words in each language. MRI uses a strong magnetic field to     image brain tissue. The patient lies on a table that slides into a narrow metal cylinder,     which is the scanner. The head is restrained gently with foam padding to limit movement. The     patient can see out of the scanner through a mirror and is in contact with the technician via     an intercom at all times during the procedure. The scans measures blood flow to different     parts of the brain, providing information about what brain regions are being used during the     tasks performed. Another scan will be done to obtain a detailed picture of the brain's     structure.      This study will evaluate the usefulness of MRI in identifying brain areas involved in     processing different languages and increase knowledge about how illness affects brain     function. It may help plan treatment for bilingual patients who must undergo brain surgery     for uncontrolled epilepsy or who have a neurological disorder affecting different languages     with varying degrees.   "
166555|NCT00016523|"     This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for     oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.   "
166556|NCT00016536|"     The purpose of this study is to find out if there are any bad effects when BufferGel or PRO     2000/5 Gel are applied to the penis of HIV-infected men.      Microbicides are products to be used by women for placing into the vagina to prevent passing     HIV from 1 person to another during sex. Studies have shown 2 investigational microbicides,     BufferGel and PRO 2000/5 Gel, to be safe and acceptable for women and HIV-negative men. It is     important to see if the side effects of these products are the same in men as those in women     and to see if there is any difference in the side effects between circumcised and     uncircumcised men.   "
166557|NCT00016549|"     This study will evaluate the effectiveness of the drug bevacizumab, in combination with     doxorubicin and docetaxel, in improving survival of patients with inflammatory breast cancer     or locally advanced breast cancer. Inflammatory breast cancer is an aggressive form of     locally advanced breast cancer that often causes a red, swollen, tender breast and is     associated with a poor prognosis. Bevacizumab blocks the growth of new blood vessels that     supply oxygen and nutrients to tumors, and therefore, may kill cancer cells or stop their     growth. Doxorubicin and docetaxel are approved drugs for treating breast cancer.      Patients 18 years of age or older with stage inflammatory breast cancer who have not been     treated with chemotherapy or radiation therapy may be eligible for this study. Candidates are     screened with a medical history and physical examination, blood and urine tests, chest x-ray,     electrocardiogram, and MUGA scan or echocardiography (see below). A mammogram of both     breasts, dynamic MRI imaging of the affected breast, computed tomography (CT) of the head,     chest, abdomen and pelvis, and a bone scan are done to determine the extent of disease.      Participants undergo the following procedures at various intervals before, during and/or     after completing chemotherapy:      Tumor and skin biopsies to study the effects of bevacizumab on tumor blood vessels, tumor     growth, and the biology of inflammatory breast cancer. A small piece of tumor tissue and a     small piece of skin from the affected breast are removed under local anesthesia for     microscopic study.      Dynamic MRI to examine changes in the blood vessels and breast cancer following bevacizumab     treatment. This test involves injecting a contrast liquid into a vein before scanning. A     standard MRI scan is done before the dynamic MRI.      Blood tests are done to 1) study clot formation and breakdown, 2) measure levels of VEGF (a     substance produced by breast cancer cells) and VCAM-1 (a substance produced by cells lining     blood vessel walls), and 3) check blood counts and liver and kidney function.      MUGA (a nuclear medicine scan that checks the heart's pumping ability) or echocardiogram     (ultrasound scan of the heart to evaluate heart function.      Blood pressure monitoring      Urine tests      CT scans and x-rays to evaluate disease before and after treatment.      Patients will have a central venous line (plastic tube) placed into a major vein in the chest     before beginning treatment. The line stays in the body during the entire treatment period and     is used to give chemotherapy and other medications, if needed, and to draw blood samples. All     treatment is given on a single day every 3 weeks. This constitutes one treatment cycle. Cycle     1 consists of bevacizumab alone; cycles 2 through 7 consist of bevacizumab with doxorubicin     and docetaxel. During each cycle, patients also receive injections under the skin of G-CSF, a     drug that raises the number of infection-fighting white blood cells, which are often     decreased as a side effect of chemotherapy. After cycle 7, patients may require surgery and     radiation or radiation alone. After radiation treatment, bevacizumab is re-started, given     alone every 3 weeks for an additional eight cycles. Patients whose tumors are positive for     estrogen or progesterone receptors will be advised to take the drug tamoxifen or anastrozole     for 5 years to decrease the chances of disease recurrence. This would begin with cycle 8.   "
166566|NCT00016718|"     Treatment of HIV-infected patients involves combining drugs from different classes of     anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase     inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too     complicated or the drugs may be too difficult to take by mouth. The purpose of this study is     to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz     (EFV), and emtricitabine (FTC) in pediatric patients who have taken few or no anti-HIV drugs.   "
166567|NCT00016731|"     The purpose of this study is to use brain imaging technology to compare how the brains of     adolescents and adults are activated during tasks that involve emotional responses.      Evidence suggests that adolescents and adults experience activation in similar brain regions     when they engage in tasks that involve the processing of emotional stimuli. However, the     degree of task-associated activation may differ between adolescents and adults. This study     will use functional magnetic resonance imaging (fMRI) to compare brain activation patterns in     adolescents and adults. This study will also be used to develop emotion-evoking fMRI tasks to     determine whether there are puberty and age-linked components of brain development.   "
166558|NCT00016562|"     This study will examine the origin and development of certain neurological diseases involving     abnormal metabolism. A significant number of patients with progressive neurological disorders     have not been diagnosed despite extensive workups. Lack of a specific diagnosis may amplify     the distress of both the patient and family and decrease the chance of obtaining effective     therapy. This study will try to advance the diagnosis and management of such patients.      Patients with a metabolic neurological disease of unknown cause or one which presents an     unusual or difficult management problem may be eligible for this study. This study does not     include patients with known or suspected leukodystrophy.      Participants will undergo various procedures, including physical and neurologic examinations,     blood and urine tests, and magnetic resonance imaging (MRI) to determine the extent and     severity of disease. MRI scanning uses a strong magnetic field and radio waves to show     structural and chemical changes in the brain. During the procedure, the patient lies on a     table in a narrow cylinder containing a magnetic field. He or she can speak with a staff     member via an intercom system at all times during the procedure. Patients will also have a     lumbar puncture (spinal tap) to examine the cerebrospinal fluid (CSF), which bathes the brain     and spinal cord. To obtain the fluid, a local anesthetic is administered and a needle is     inserted in the space between the bones in the lower back where the CSF circulates below the     spinal cord. A small amount of fluid is collected through the needle. Although spinal fluid     will not be examined regularly, this test may be requested during some clinic visits.      X-rays, nuclear medicine scans and consultations may be obtained as needed. Other tests may     include electroencephalograms (brain wave recordings), psychological tests, and speech and     language and rehabilitation evaluations. A skin biopsy may be done to grow cells in culture     for metabolic and genetic testing and to analyze the skin under a microscope. For the biopsy,     an area of skin is numbed with an anesthetic and a small circular area is removed, using a     sharp cookie cutter-type instrument.      First degree relatives (parents, children or siblings) of patients with a metabolic disorder     of unknown cause will be asked to provide a blood sample for DNA studies to try to identify     genetic basis of the disorder.      The study is expected to continue for 3 years, with yearly monitoring of patients for changes     in neurological, ophthalmological and general medical status.   "
166559|NCT00016588|"     The purpose of this study is to look at the effectiveness of tenofovir disoproxil fumarate     (TDF) in HIV-infected patients who have never taken anti-HIV drugs.   "
166560|NCT00016601|"     The purpose of this study is to look at the level of depo-medroxyprogesterone acetate (DMPA     or Depo-Provera) in the blood to see if is affected by certain anti-HIV drugs (nelfinavir     [NFV], efavirenz [EFV], indinavir [IDV] in combination with ritonavir [RTV], and nevirapine     [NVP]). This study will also look at the levels of these anti-HIV drugs to see if they are     affected by DMPA.      DMPA is a hormonal birth control method that is given as an injection. It is not known if     taking DMPA together with anti-HIV drugs changes the amount of DMPA and/or the amount of     anti-HIV drugs in the blood. If higher levels of DMPA occur, side effects may increase. If     lower levels of anti-HIV drugs occur, the drugs may become less effective against HIV. This     study will look at the levels of anti-HIV drugs and DMPA in the blood when these medications     are used together.   "
166561|NCT00016627|"     To map the gene (or genes) for familial pulmonary fibrosis.   "
166562|NCT00016653|"     This study will help to determine the effectiveness of glutamine and creatine as a possible     therapy for DMD. Boys with DMD who are enrolled in this trial will be randomly chosen to     receive creatine monohydrate or glutamine or an inactive placebo orally for six months. Once     a month during the six-month treatment period, the study participants will have their muscle     strength evaluated using manual and computerized testing methods. This study will be     conducted at several CINRG Centers throughout the U.S., Belgium, Israel and Puerto Rico. This     study is supported by the Muscular Dystrophy Association.   "
166563|NCT00016666|"     The purpose of this study is to determine what dose of a new timed-release tablet of the drug     propranolol will reduce secretion of the hormone melatonin in healthy volunteers. This study     will also determine whether suppressing melatonin will improve depressive symptoms in people     with seasonal affective disorder (SAD).      SAD (sometimes referred to as winter depression) is a condition in which people experience     depression as a result of seasonal variations in light. Human brains have a circadian     pacemaker that regulates many body functions. As the seasons change and light duration     varies, the circadian pacemaker regulates seasonal behavior by transmitting a signal of day     length to the pineal gland, which secretes the hormone melatonin. Melatonin secretion     increases in the winter as the duration of light decreases. Evidence suggests that the     melatonin signal of seasonal change is present in people with SAD but not in healthy     volunteers; thus there is a possibility that seasonal changes which influence the duration of     melatonin secretion control the course of illness in individuals with SAD. This study will     determine whether propranolol can shorten the duration of melatonin secretion and mimic the     effect of summer days to improve symptoms of depression in people with SAD.      Healthy volunteers will be admitted to the hospital for about 2 days. The volunteers will     receive either propranolol or placebo (an inactive pill) before going to bed and upon     awakening. Blood samples will be collected at various times throughout the study.      Participants with SAD will be interviewed periodically on an outpatient basis to determine     the onset of depression in the fall or winter. Two weeks after depressive symptoms arise,     participants will begin treatment with either propranolol or placebo. At the beginning of the     treatment, participants will be hospitalized for about 2 days and will have blood collected     at various times. During the hospital stay, participants will continue treatment with either     propranolol or placebo in the morning and at night; all participants will receive propranolol     at some point during the study. Participants will be interviewed weekly for 4 weeks.      Premenopausal women with or without SAD will keep a record of their menstrual cycles and will     use a urine test kit to identify the time of ovulation during the month before and after     admission to the hospital.   "
166564|NCT00016679|"     This study will determine the optimal dose of 1-octanol that will safely reduce tremors in     patients with essential tremor-a disorder in which the hands, and sometimes the head, shake     involuntarily. Current treatments may be ineffective or produce unwanted side effects.     Ethanol (the chemical in beer and wine that causes intoxication) reduces tremor in many     patients, but patients generally don't use it regularly because it interferes with daily     activities. Laboratory studies show that 1-octanol, a drug that is similar to ethanol, may     have the same beneficial effect on tremors with less likelihood of intoxication.      Patients 21 years of age and older with essential tremor may be eligible for this 10-day     study. Candidates will be evaluated with a neurological examination, blood tests, urinalysis     and electrocardiogram (EKG). Those enrolled will be admitted to the hospital for 4 days for     1-octanol administration and monitoring. On day 1, patients will have a medical history and     physical examination. A catheter (a thin plastic tube) will be placed in a vein of the     forearm for sampling blood. Patients will take one 1-octanol capsule (at one of seven doses)     by mouth and will be monitored for tremors and drug side effects. Blood will be sampled     periodically in the first 3 hours to determine 1-octanol blood levels. On days 2 and 3,     patients will be monitored for additional side effects. On days 3 and 4, laboratory tests     (blood and urine) will be done to evaluate liver and kidney function. On day 4, the catheter     will be removed and the patient will be discharged from the hospital. A follow-up visit will     be scheduled 1 week after discharge for a physical examination and blood, urine and EKG     tests.   "
166565|NCT00016692|"     The purpose of the study is to see if Z-100 (an investigational drug) treatment is safe in     HIV patients who have never received treatment for their HIV, who have not been taking highly     active antiretroviral therapy (HAART) for at least 8 weeks, or who have been stable on their     current first or second HAART regimen for at least 12 weeks.   "
166578|NCT00016926|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who     have advanced, persistent, or recurrent cervical cancer.   "
166568|NCT00016744|"     We are testing a new combination of medicines, to determine if they could be used to treat     cystic fibrosis (CF). Subjects with CF who have two copies of the most common mutation     (change) found in patients with CF called DF508. CF is caused by a lack of chloride movement     in the nose, sinuses, lungs, intestines, pancreas and sweat glands. We are conducting this     study to determine the safety of using a combination of two medicines, Phenylbutyrate and     Genistein, to improve the ability of the cells lining the nose to regulate movement of salt     (chloride) and water in people with CF.      Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases     (which are very different from CF), Phenylbutyrate is an investigational drug for the purpose     of this study. Genistein is a naturally occurring substance that is found in food products     such as soy and tofu, but is also an investigational drug for this study. Both drugs may be     able to restore normal chloride movements in body organs and glands. We will be studying salt     and water in the nose movement by a technique called nasal transepithelial potential     difference (NPD).   "
166569|NCT00016783|"     Some patients taking anti-HIV drugs as part of highly active antiretroviral therapy (HAART)     do not show any HIV in the blood; however, some HIV will remain hidden in the body and, if     the drugs are stopped, will return to the blood. The purpose of this study is to determine if     short periods of stopping HAART increase the activity of CD8 and CD4 cells (cells of the     immune system that fight infection), if repeated stopping of these drugs for longer periods     of time and restarting them will increase effectiveness of HAART, and if the increased immune     system activity as a result of stopping treatment leads to lower levels of HIV over time.   "
166570|NCT00016796|"     This study will determine baseline language skills in children 4 to 8 years old. The data     will be used to design studies using functional magnetic resonance imaging (fMRI) to identify     what areas of the brain in children are involved in understanding language. This information     is important for children who require brain surgery to control seizures.      Healthy normal volunteers between the ages of 4 and 8 years who have an IQ of 70 or more; who     have no history of neurologic, psychiatric or language disorder; who are performing at or     above grade level, and who are native English speakers may be eligible for this study.      Participants will be asked to do the following:        -  name pictures or read words that appear on a computer screen        -  listen to stories and answer questions about them        -  match pictures to a spoken word      The children's responses will be recorded.   "
166571|NCT00016835|"     The purpose of this project is to obtain important preliminary data necessary to support     design of a full scale, multicenter randomized clinical trial (RCT) to evaluate the effect of     treating periodontal infection on glycemic control in type 2 diabetes mellitus.   "
166572|NCT00016848|"     This study will try to determine if intake of dietary fats or carbohydrates influences the     tendency to gain weight or accumulate body fat. It will examine how the hormones that     regulate weight may change with a shift from a balanced diet to one that is low in fat or     carbohydrate, irrespective of caloric intake.      Men and women between the ages of 18 and 40 years with a body mass index of 30 to 49 kg/m2     may be eligible for this study. Candidates will be screened with a history, physical     examination, blood tests and questionnaires regarding activity, prior diets, and eating     patterns.      Participants will follow two separate diet regimens for 5 days each. The first will be a     balanced diet, and the second will be either a low-fat/high-carbohydrate diet or a     low-carbohydrate/high-fat diet. The diets are not designed to produce weight loss.     Participants will receive all their meals and snacks for the two diets from the National     Institutes of Health and, for the first 3 days of each diet, will be seen as outpatients. For     days 4 and 5 of each diet, they will be admitted to the Clinical Center and will undergo the     following procedures:        -  Blood tests - Blood samples will be collected every 30 minutes over a 24-hour period          through an indwelling catheter in the arm. A total of about 15 tablespoons will be drawn          for each of the two diets.        -  24-hour urine collection - One 24 hour urine collection will be done at home the day          before admission to the Clinical Center, and the other will be done during the hospital          stay.        -  Urinalysis and pregnancy test - A small urine sample will be taken and women will          provide an additional sample for a pregnancy test.        -  Body measurements - Height and weight will be measured using scales. Body fat will be          measured by two methods: skin fold thickness, measured with calipers in 5 separate          places; and body circumference measurements, in which body parts are measured with a          tape measure.        -  Bod pod measurement - Proportions of fat and non-fat tissue in body weight are measured          while the participant sits in a capsule-like device for 5 minutes.        -  Bioelectric impedance analysis - Proportions of body fat are measured based on          conduction of a small electric current.        -  Total body water estimate -The proportion of body weight that is water is determined,          using a method that involves drinking a cup of a special kind of heavy water          (deuterium) and then measuring the amount of heavy water in a urine sample taken after 4          hours.        -  Exercise - Participants will maintain their usual exercise routine, as it was before          beginning the study.   "
166573|NCT00016861|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children who have     refractory or progressive solid tumors.   "
166574|NCT00016874|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining 3-AP, cisplatin, and     paclitaxel in treating patients who have advanced or metastatic cancer.   "
166575|NCT00016887|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill cancer cells. Peripheral stem cell transplant may allow the doctor     to give higher doses of chemotherapy drugs and kill more cancer cells. Interferon alfa may     interfere with the growth of cancer cells. It is not yet known whether giving more than one     drug (combination chemotherapy) with radiation therapy and peripheral stem cell transplant is     more effective than chemotherapy followed by interferon alfa in treating mantle cell     lymphoma.      PURPOSE: This randomized phase III trial compares how well chemotherapy followed by radiation     therapy, chemotherapy, and peripheral stem cell transplant works compared to chemotherapy     plus interferon alfa in treating patients who have stage III or stage IV mantle cell     lymphoma.   "
166576|NCT00016900|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of PNU-93914 in treating patients who have     locally advanced or metastatic cancer of the esophagus.   "
166577|NCT00016913|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs     such as goserelin or leuprolide may stop the adrenal glands from producing androgens.     Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy,     hormone therapy, and radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying giving chemotherapy together with hormone therapy     and radiation therapy in treating patients with locally advanced prostate cancer.   "
166580|NCT00016952|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving the drugs in different combinations may kill more tumor     cells.      PURPOSE: Phase II trial to compare the effectiveness of either irinotecan or fluorouracil     plus leucovorin in treating patients who have metastatic colorectal cancer that has been     previously treated with oxaliplatin with or without irinotecan.   "
166581|NCT00016965|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who     have advanced pancreatic cancer.   "
166582|NCT00016978|"     Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil and     leucovorin in treating patients who have metastatic colorectal cancer that has been     previously treated with irinotecan. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Combining more than one drug may kill     more tumor cells.   "
166583|NCT00016991|"     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells     and slow the growth of glioblastoma multiforme.      PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have     glioblastoma multiforme in first relapse.   "
166584|NCT00017004|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa     may stimulate red blood cell production to treat anemia in patients who have received     chemotherapy and/or radiation therapy for cervical cancer. Randomized phase III trial to     study the effectiveness of epoetin alfa in treating anemia in patients who have cervical     cancer.   "
166585|NCT00017017|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of CT-2103 in treating patients who have     recurrent ovarian epithelial or fallopian tube cancer or primary peritoneal cancer.   "
166586|NCT00017030|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients     who have unresectable advanced or metastatic soft tissue sarcoma.   "
166587|NCT00017043|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who     have metastatic stomach cancer previously treated with chemotherapy.   "
166588|NCT00017056|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who     have recurrent metastatic stomach cancer that has been previously treated with chemotherapy.   "
166589|NCT00017069|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and     dexamethasone in treating patients who have recurrent or refractory stage II or stage III     multiple myeloma.   "
166590|NCT00017082|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who     have recurrent metastatic colorectal cancer.   "
166591|NCT00017095|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Currently patients with breast cancer are treated with     one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may     help doctors predict how well patients with breast cancer will respond to treatment and help     doctors choose the best drug regimen to treat each patient.      PURPOSE: This randomized phase III trial is studying giving different regimens of     chemotherapy and comparing how well they work in treating women with large operable or     locally advanced or inflammatory breast cancer. This study is also looking at whether     analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well     patients will respond to treatment and help doctors choose the best drug to treat each     patient.   "
166592|NCT00017108|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. It is not yet known which chlorambucil regimen is more effective     in treating advanced chronic lymphocytic leukemia.      PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of     chlorambucil in treating patients who have advanced chronic lymphocytic leukemia.   "
166593|NCT00017121|"     RATIONALE: Inhaling sargramostim may interfere with the growth of tumor cells and may be an     effective treatment for melanoma that has spread to the lung.      PURPOSE: This phase I trial is studying the side effects and best dose of inhaled     sargramostim in treating patients with melanoma that is metastatic to the lung.   "
166594|NCT00017134|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. It is not yet known whether fenretinide given before surgery is more     effective in preventing ovarian cancer than surgery alone.      PURPOSE: Randomized clinical trial to compare the effectiveness of fenretinide followed by     surgery with that of surgery alone in preventing ovarian cancer in patients who are at     increased risk.   "
166595|NCT00017147|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     O6-benzylguanine may help carmustine kill more tumor cells by making tumor cells more     sensitive to the drug. It is not yet known whether radiation therapy and carmustine are more     effective with or without O6-benzylguanine.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus     carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed     glioblastoma multiforme or gliosarcoma.   "
166624|NCT00006458|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy     in treating patients who have relapsed or refractory non-small cell lung cancer.   "
166596|NCT00017160|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation     therapy, and surgery in treating patients who have primary or recurrent sarcoma.   "
166597|NCT00017173|"     RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability     to fight cancer. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     tumor cells. Combining chemotherapy and radiation therapy with the p53 gene may kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of gene therapy plus surgery followed by     cisplatin and radiation therapy in treating patients who have newly diagnosed resectable     stage III or stage IV cancer of the mouth or throat.   "
166598|NCT00005992|"     RATIONALE: Vaccines made from a person's peripheral stem cells may make the body build an     immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have metastatic prostate cancer that has not responded to hormone therapy.   "
166599|NCT00005993|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.     Filgrastim and stem cell factor may increase the number of immune cells found in bone marrow     or peripheral blood and may help a person's immune system recover from the side effects of     cancer therapy. Peripheral stem cell transplantation may be able to replace immune cells that     were destroyed by therapy used to kill cancer cells.      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 and stem cell factor     following peripheral stem cell transplantation in treating patients who have non-Hodgkin's     lymphoma, Hodgkin's disease, or advanced breast cancer.   "
166600|NCT00005994|"     RATIONALE: Patient education may improve the effectiveness of ondansetron in preventing     nausea and vomiting in patients receiving chemotherapy.      PURPOSE: This randomized clinical trial is studying how well patient education works in     preventing nausea and vomiting in cancer patients receiving chemotherapy.   "
166601|NCT00005995|"     RATIONALE: AE-941 may stop the growth of kidney cancer by stopping blood flow to the tumor.      PURPOSE: Randomized phase III trial to determine the effectiveness of AE-941 in treating     patients who have metastatic kidney cancer that has not responded to biological therapy.   "
166602|NCT00005996|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. SU5416 may stop the growth of solid tumors by stopping blood flow     to the tumor. Combining more than once chemotherapy drug with SU5416 may kill more tumor     cells.      PURPOSE: Phase I trial to study the effectiveness of SU5416 combined with gemcitabine and     cisplatin in treating patients who have advanced solid tumors.   "
166603|NCT00005997|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating     patients who have advanced liver and/or biliary cancer.   "
166604|NCT00005998|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation     using specially treated stem cells may allow the doctor to give higher doses of chemotherapy     drugs and radiation therapy and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation     using specially treated stem cells in treating patients who have non-Hodgkin's lymphoma or     Hodgkin's disease.   "
166605|NCT00005999|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have stage IVB or recurrent cervical cancer.   "
166606|NCT00006000|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. SU5416 may stop the growth of solid tumors by stopping blood flow     to the tumor. Combining SU5416 with chemotherapy may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of SU5416 plus irinotecan and cisplatin in     treating patients who have advanced solid tumors.   "
166607|NCT00006001|"     Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic     or locally recurrent colorectal cancer. SU5416 may stop the growth of colorectal cancer by     stopping blood flow to the tumor.   "
166608|NCT00006002|"     RATIONALE: SU5416 may stop the growth of prostate cancer by stopping blood flow to the tumor.     Dexamethasone may be effective in slowing the growth of prostate cancer cells. It is not yet     known whether SU5416 or dexamethasone is more effective in treating progressive prostate     cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of SU5416 with that of     dexamethasone in treating patients who have progressive prostate cancer that has not     responded to hormone therapy.   "
166609|NCT00006443|"     The purpose of this study is to compare changes in HIV levels and certain immune cells among     patients at different stages of HIV infection. This study will also see how a combination of     stavudine (d4T), lamivudine (3TC), indinavir (IDV), and nelfinavir (NFV) affects these     levels.      Current findings in anti-HIV drug treatment have led to a greater understanding of the     background of HIV. To find the best anti-HIV treatment to eliminate all HIV viruses, cells     and tissues infected with the HIV virus are examined after combination anti-HIV treatment,     when the level of HIV infection is low. The ERADICATE study will examine the idea that HIV     viruses can be eliminated at any stage of infection over time.   "
166610|NCT00006444|"     The purpose of this study is to see how often human papillomavirus (HPV) occurs in     HIV-infected women who have not taken anti-HIV drugs and to learn whether taking anti-HIV     drugs will affect HPV in women.      HIV infection increases the risk of getting HPV infection. Findings suggest that HIV     infection as well as a weakened immune system may increase the chances of getting HPV.     Aggressive anti-HIV medication has been shown to strengthen the immune system. Researchers     want to learn whether anti-HIV drugs affect the HPV virus or decrease the chances of getting     HPV. This study is important because it may provide important information to help manage a     woman's health and to determine a woman's risk for developing problems with the cervix (outer     end of the uterus).   "
166611|NCT00006445|"     Too much or too little genetic information (chromosome material) can cause abnormal     development of the fetus or death. Each year approximately 2.5 million pregnant women are     screened for Down Syndrome using invasive screening methods (amniocentesis or chorionic     villus sampling). This 11 center study of 38,000 women will compare the accuracy of the     several non-invasive tests in the first and second trimesters of pregnancy versus     amniocentesis or diagnosis at birth to diagnose aneuploidy or Down Syndrome.   "
166612|NCT00006446|"     Children who are at risk for problems in school may do better if they and their parents are     taught how to communicate with each other between age 3 and 6 when the children enter     kindergarten. Three groups of 3 year olds who are in Head Start in the Nashville area will be     randomized with their parents to either a 3 year program of skill building or to a control     (Head Start only). The children will be tested at the end of the 3 year study and 6 months, 1     year and 2 years later.   "
166613|NCT00006447|"     This randomized trial tested a 6 month intervention of computer network vs a control group     (standard care) to improve quality of life and health status for traumatic brain injury (TBI)     patients and their caregivers. The network, termed the Trauma Recovery Support System (TRSS),     consisted of a central computer system connected via modem to a personal computer in the     caregiver's home. Users could access via the Internet special modules and communication     services to help them cope with their new roles as caregivers and with accompanying social     isolation. These modules were an on-line discussion group, an ask an expert questions     function, a database of previously asked questions with answers, a database of community     resources, and a reference library.   "
166614|NCT00006448|"     Pain is a major problem for people after spinal cord injuries and amputations. This is a     study to test how pain is affected by adding methadone to a six-week program of weekly     physical therapy, relaxation training and counseling. Individuals who qualify for this study     will receive a comprehensive medical and physical therapy evaluation.   "
166615|NCT00006449|"     The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with     two psychotherapies that differ in scope and intensity. The effect of these treatments will     be assessed with patients who differ in their psychosocial need and resources at their     disposal, and in their level of cravings for alcohol.   "
166616|NCT00006450|"     This study will examine the safety and effectiveness of treating brain tumors in children     with a continuous infusion of phenylbutyrate. A breakdown product of this drug,     phenylacetate, is normally found in low concentrations in the blood. At much higher     concentrations, phenylbutyrate and phenylacetate are active against cancer in animals.      Patients between 2 and 21 years old with a brain tumor that has progressed or recurred after     radiation or chemotherapy, including bone marrow transplant, may be eligible for this study.     Candidates will be screened with a medical history and physical examination, blood tests,     magnetic resonance imaging (MRI) or computerized tomography (CT) of the head and, if needed,     a spinal fluid test and bone marrow test.      Study participants will have a continuous infusion of phenylbutyrate for two 28-day     cycles-every day, 24 hours a day, 7 days a week. The medicine will be infused through a thin     tube (catheter) placed in a large vein in the upper chest, delivered through a portable     infusion pump. Patients will be hospitalized for at least 3 days when the treatment begins.     If there are no side effects at that time, the infusions can continue on an outpatient basis.     The patient or care giver will receive the medicine in 4-day supplies and will be taught how     to change the bag and tubing daily for drug administration, as well as how to use the     infusion pump. Patients will be monitored with weekly blood tests to look for side effects     and measure blood levels of phenylbutyrate. They will have a physical examination at least     once a week. At the end of the second 28-day cycle, patients will have a CT or MRI scan to     evaluate the tumor's response to treatment. Patients whose tumor has grown will stop     treatment and come off the study. Those whose tumor has remained stable or shrunk may     continue phenylbutyrate as long as the treatment is beneficial and there are no serious side     effects. CT or MRI scans will be done after every 2 cycles (or sooner if needed) to evaluate     the treatment.      Patients with certain tumor types (medulloblastoma, PNET, ependymoma, malignant germ cell     tumor and pineoblastoma) or who have symptoms that indicate there might be tumor along the     spinal cord may have a spinal tap. For this procedure, the patient lies on the side and a     needle is inserted between two vertebrae (bones of the spine) in the lower back, into the     cerebrospinal fluid space. A sample of fluid is drawn for testing for cancer cells. If the     tumor has spread through the spinal fluid, a spinal tap will be done every other cycle (every     2 months) to monitor the effects of therapy.   "
166617|NCT00006451|"     RATIONALE: Bone marrow transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy used to kill cancer cells.      PURPOSE: Randomized phase II/III trial to determine the effectiveness of bone marrow     transplantation in treating patients who have leukemia.   "
166618|NCT00006452|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     gadolinium texaphyrin may make tumor cells more sensitive to radiation therapy.      PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation     therapy in treating patients who have supratentorial glioblastoma multiforme that has not     been previously treated.   "
166619|NCT00006453|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or     without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has     not responded to previous chemotherapy.   "
166620|NCT00006454|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known if paclitaxel plus carboplatin is more effective with or without topotecan for     ovarian epithelial cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel plus     carboplatin with or without topotecan in treating patients who have stage IIB, stage III, or     stage IV ovarian epithelial cancer.   "
166621|NCT00006455|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is more effective for treating anaplastic     large cell lymphoma.      PURPOSE: This randomized phase III trial is studying several different regimens of     combination chemotherapy to compare how well they work in treating children with anaplastic     large cell lymphoma.   "
166622|NCT00006456|"     RATIONALE: Stereotactic radiosurgery delivers x-rays directly to the tumor and may cause less     damage to normal tissue.      PURPOSE: Phase II trial to study the effectiveness of stereotactic radiosurgery in treating     patients who have liver metastases, lung metastases, or other advanced solid tumors.   "
166623|NCT00006457|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer.      PURPOSE: Randomized phase I trial to study the effectiveness of oltipraz in preventing lung     cancer in people who smoke.   "
166625|NCT00006459|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known if paclitaxel is more effective with or without gemcitabine for advanced breast     cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel with or without     gemcitabine in treating women who have advanced breast cancer.   "
166626|NCT00006460|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperbaric oxygen     may increase the effectiveness of radiation therapy. Combining hyperbaric oxygen with     radiation therapy may be an effective treatment for glioblastoma multiforme.      PURPOSE: Phase I/II trial to study the effectiveness of combining radiation therapy with     hyperbaric oxygen in treating patients who have newly diagnosed glioblastoma multiforme.   "
166627|NCT00006461|"     This phase III trial is studying how well combination chemotherapy followed by second-look     surgery and radiation therapy works in treating children with nonmetastatic medulloblastoma     or primitive neuroectodermal tumor. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy     x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with     surgery and radiation therapy may kill more tumor cells.   "
166628|NCT00006462|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who     have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.   "
166629|NCT00006463|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.      PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children     who have refractory solid tumors.   "
166630|NCT00006464|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of UCN-01 and cisplatin in treating     patients who have advanced or metastatic solid tumors.   "
166631|NCT00006465|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating     patients who have advanced solid tumors.   "
166632|NCT00006466|"     RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the     immune system and stop cancer cells from growing.      PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients     who have myeloma.   "
166633|NCT00006467|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with ISIS 2503 in     treating patients who have advanced or metastatic cancer of the pancreas.   "
166634|NCT00006468|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which regimen of combination chemotherapy is more effective for metastatic     colorectal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination     chemotherapy regimens in treating patients who have metastatic colorectal cancer.   "
166635|NCT00006469|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining these treatments before surgery may kill more tumor cells in patients with     non-small cell lung cancer.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation     therapy before surgery in treating patients who have stage IIB non-small cell lung cancer or     stage IIIA non-small cell lung cancer.   "
166636|NCT00006470|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation     therapy uses high-energy x-rays to damage tumor cells. Combining these two treatments may     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with     radiation therapy in treating patients who have stage II or stage IIIA non-small cell lung     cancer that has been completely removed in surgery.   "
166637|NCT00006471|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who     have recurrent or metastatic head and neck cancer.   "
166638|NCT00006472|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Giving chemotherapy drugs and radiation therapy before surgery may shrink the tumor so that     it can be removed during surgery.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation     therapy given before surgery in treating patients who have stage I, stage II, or stage III     esophageal cancer.   "
166639|NCT00006473|"     Phase II trial to study the effectiveness of oxaliplatin in treating patients who have     relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways     to stop tumor cells from dividing so they stop growing or die   "
166640|NCT00006474|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and     O6-benzylguanine in treating patients who have newly diagnosed, recurrent, or progressive     anaplastic glioma.   "
166641|NCT00017186|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and epirubicin in     treating patients who have malignant mesothelioma.   "
166642|NCT00017199|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have     metastatic neuroendocrine tumors.   "
166644|NCT00017225|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Peripheral stem cell transplantation may be able to replace immune cells that were destroyed     by chemotherapy or radiation therapy used to kill tumor cells. Combining these therapies may     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation     therapy with or without peripheral stem cell transplantation in treating patients who have     neuroblastoma.   "
166645|NCT00017238|"     Phase I trial to study the effectiveness of KRN5500 in treating patients who have solid     tumors. Drugs used in chemotherapy, such as KRN5500, work in different ways to stop cancer     cells from dividing so they stop growing or die   "
166646|NCT00017251|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs. Phase I     trial to study the effectiveness of combination chemotherapy and oblimersen in treating     patients who have extensive-stage small cell lung cancer   "
166647|NCT00017264|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of atrasentan in treating patients who have     progressive or recurrent malignant glioma.   "
166648|NCT00017277|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may     help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is     more effective with or without epoetin alfa in treating head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without epoetin alfa in treating patients who have head and neck cancer.   "
166649|NCT00017290|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Vaccines may make the body build an immune response to kill     cancer cells. It is not yet known which regimen of chemotherapy combined with vaccine therapy     is more effective for non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to determine the effectiveness of combination     chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have     stage III or stage IV non-Hodgkin's lymphoma.   "
166650|NCT00017303|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and     by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and     IM-862 may kill more tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and     IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal     cancer.   "
166651|NCT00017316|"     Phase II trial to study the effectiveness of combining thalidomide and SU5416 in treating     patients who have metastatic melanoma. Thalidomide combined with SU5416 may stop the growth     of metastatic melanoma by stopping blood flow to the tumor.   "
166652|NCT00017329|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have     metastatic kidney cancer.   "
166653|NCT00017342|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 with cytarabine     in treating patients who have relapsed primary acute myelogenous leukemia.   "
166654|NCT00017355|"     RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may     make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have metastatic melanoma.   "
166655|NCT00017368|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Peripheral     stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     peripheral stem cell transplantation in treating children who have newly diagnosed     neuroblastoma.   "
166656|NCT00017381|"     This phase I trial is studying how well monoclonal antibody therapy with peripheral stem cell     transplant works in treating patients with non-Hodgkin's lymphoma. Monoclonal antibodies,     such as rituximab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Peripheral stem cell transplant may allow the doctor to     give higher doses of monoclonal antibodies and kill more cancer cells   "
166657|NCT00017394|"     Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in     treating patients who have stage IV breast cancer. Monoclonal antibodies such as bevacizumab     can locate tumor cells and either kill them or deliver tumor-killing substances to them     without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die. Combining monoclonal antibody with     chemotherapy may kill more cancer cells   "
166658|NCT00017407|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. ISIS 3521 may help kill more cancer cells by making tumor cells     more sensitive to chemotherapy. It is not yet known if carboplatin and paclitaxel are more     effective with or without ISIS 3521.      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin and     paclitaxel with or without ISIS 3521 in treating patients who have stage IIIB or stage IV     non-small cell lung cancer.   "
166659|NCT00017433|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have relapsed or refractory stage II or stage III multiple myeloma.   "
166660|NCT00017446|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of CP4071 in treating patients who have     locally advanced or metastatic soft tissue sarcoma.   "
166661|NCT00017459|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if cisplatin and vinorelbine are more effective     with or without tirapazamine in treating non-small cell lung cancer      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus     vinorelbine with or without tirapazamine in treating patients who have stage IIIB or stage IV     non-small cell lung cancer.   "
166662|NCT00017472|"     Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing     substances to them without harming normal cells. Phase I trial to study the effectiveness of     monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia,     lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia.   "
166663|NCT00017485|"     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to     light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by cancer cells     and, when exposed to light, become active and kill the cancer cells.      PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in     treating patients who have basal cell skin cancer.   "
166664|NCT00017498|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who     have recurrent or metastatic adenoid cystic cancer of the head and neck.   "
166665|NCT00017511|"     RATIONALE: Cevimeline may be effective in treating dry mouth that is caused by radiation     therapy for head and neck cancer. It is not yet known if cevimeline is more effective than no     therapy in treating dry mouth caused by radiation therapy.      PURPOSE: Randomized phase III trial to determine the effectiveness of cevimeline in treating     patients who have dryness of the mouth caused by radiation therapy for head and neck cancer.   "
166666|NCT00017524|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of AG2037 in treating patients who have     advanced, metastatic, or recurrent solid tumors.   "
166667|NCT00017862|"     This study will examine the safety and effectiveness of a single dose of anti-interleukin-5     antibody (SCH 55700) in reducing the number of eosinophils (a type of white blood cell) in     patients with hypereosinophilic syndrome. Patients with this disease have too many     eosinophils in the blood and in body tissues, which cause damage to the affected organs-most     commonly the heart, nerves and skin. SCH 55700 is an antibody to interleukin 5-a hormone-like     substance produced by white blood cells that plays a significant role in eosinophilia. SCH     55700 has lowered eosinophilia blood counts in patients with asthma and reduced the number of     these cells in tissues of animals with asthma.      Patients with hypereosinophilic syndrome 18 years of age and older who have not responded to     standard therapy with steroids, interferon and hydroxyurea or cannot take these drugs may be     eligible for this study. Candidates will be screened with a medical history, physical     examination, eye examination, and blood tests. Depending on the patient's symptoms, other     diagnostic tests may be done, including studies of the eyes, lungs, skin, nerves or heart.     Skin biopsy and bronchoalveolar lavage may be included in the diagnostic evaluation. For the     skin biopsy, a small area about 1/3 inch in diameter is numbed and a small core of skin is     surgically removed for study under the microscope. Bronchoalveolar lavage involves inserting     a catheter (flexible tube) into the lungs to instill saline (salt water) and obtain a tissue     sample. This test will be done only if clinically necessary.      Those enrolled in the study will be admitted to the NIH Clinical Center for a single dose of     SCH 55700, injected into an arm vein. They will be monitored in the hospital for at least 72     hours for changes in eosinophil count and side effects of the injection. After discharge,     laboratory tests will be done weekly for the first month, either at the Clinical Center or by     the patient's local physician. Follow-up visits will then be scheduled monthly for 1 year or     until the patient's eosinophil count returns to pre-treatment levels for 2 consecutive     months. Follow-up visits will include a history, physical examination and blood tests,     including studies on how immune cells and other substances in the blood activate or stimulate     eosinophilia. A chest X-ray, electrocardiogram and pulmonary function tests will be done at     1, 3, 6 and 12 months to evaluate organ damage. Other tests may be done if medically     indicated.      Bone marrow biopsy and aspiration will be done before receiving SCH 55700 and one month after     the injection to evaluate the effects of SCH 55700 on eosinophil production in the bone     marrow. For this test, an area of skin and bone is numbed and a very sharp needle is used to     withdraw a sample of the bone marrow. Leukapheresis will also be done before and 1 month     after SCH 55700 treatment to obtain cells for studying the effect of SCH 55700 on eosinophil     activation, function and survival. For this procedure, whole blood is collected through a     needle in an arm vein. The blood circulates through a machine that separates it into its     components. The white cells are then removed, and the rest of the blood is returned to the     body, either through the same needle used to draw the blood or through a second needle placed     in the other arm.   "
166668|NCT00017875|"     This study will use transcranial magnetic stimulation to examine how the brain controls     muscle movement in focal and generalized types of dystonia. Dystonia is a movement disorder     in which involuntary muscle contractions cause uncontrolled twisting or abnormal postures.     Dystonia may be focal, involving just one region of the body, such as the hand, neck or face.     Focal dystonia usually begins in adulthood. Generalized dystonia, on the other hand,     generally begins in childhood or adolescence. Symptoms begin in one area and then become more     widespread.      Healthy normal volunteers and patients with focal or generalized dystonia 8 years of age and     older may be eligible for this study. First-degree relatives of patients will also be     enrolled.      In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp     and brief electrical currents are passed through the coil, creating magnetic pulses that pass     into the brain. These pulses generate very small electrical currents in the cortex-the outer     part of the brain-briefly disrupting the function of the brain cells in the stimulated area.     The stimulation may cause muscle twitching or tingling in the scalp, face and limbs. During     the stimulation, the subject will be asked to either keep the hand relaxed or to slightly     tense certain muscles in the hand or arm. The test will last about 1.5 hours.      The cause of dystonia is unknown. It is hoped that a comparison of brain activity in normal     volunteers, patients and their relatives not affected by dystonia will help scientists learn     why some people develop dystonic movements.   "
166669|NCT00017914|"     This study will evaluate subjects with adult- and childhood-onset myositis to learn more     about their cause and the immune system changes and medical problems associated with them.     Myositis is an inflammatory muscle disease that can damage muscles and other organs,     resulting in significant disability.      Children or adults with polymyositis or dermatomyositis or a related condition may be     evaluated under this study. Healthy children or adults will also be enrolled as controls,     for comparison of test results.      All patients will undergo a complete history (including completing some questionnaires) and     physical examination, review of medical records, and blood and urine tests. Patients may then     choose to participate in an additional 1- to 5-day evaluation, which will include some or all     of the following diagnostic, treatment or research procedures:        1. Standardized muscle strength testing, range of motion of joints and walking (gait)          analysis by a physiotherapist; completion of a questionnaire regarding ability to          perform daily tasks        2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of          a small skin sample under local anesthetic)        3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg          muscles        4. Swallowing studies, including a physical examination and questionnaire on swallowing          ability, studies of tongue strength, and ultrasound imaging during swallowing, and          possibly, a modified barium swallow        5. Voice and speech assessment, possibly including computerized voice analysis and          laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera          placed in the mouth to view and record vocal cord function        6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a          breathing machine) to evaluate lung function and, possibly, chest X-ray        7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly,          echocardiogram (ultrasound imaging of the heart)        8. Endocrine evaluation        9. Eye examination, in patients with vision loss or other eye symptoms       10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape          measurements or bioelectric impedance testing, a painless procedure in which wires are          attached to the extremities with a sticky paste.       11. Muscle ultrasound.       12. Electromyography (record of the electrical activity of muscles)       13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic          examination)      All patients may have only a one-time evaluation or may return for one follow-up evaluations     (either the 1-day or 3- to 5-day evaluation) over a 1-year period.      Healthy children will undergo a medical history and brief physical examination; blood and     urine tests; speech and swallowing studies including questionnaires and physical examination,     tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18     years old may also have exercise testing.   "
166670|NCT00017927|"     This study will examine the effect of pegvisomant on growth hormone excess in patients with     McCune-Albright syndrome (MAS). Patients with this disease have polyostotic fibrous     dysplasia-a condition in which areas of normal bone are replaced with fibrous growth similar     to scar tissue, abnormal skin pigmentation (birth marks) and precocious (early) puberty.     About 10 percent of patients have excess growth hormone (GH). GH stimulates the production of     another hormone called insulin-like growth factor 1 (IGF-1). Together, GH and IGF-1 affect     bone growth. The excess of these hormones in MAS can cause overgrowth of the bones of the     face, hands and feet, excess sweating, or increased height.      Pegvisomant is a synthetic drug that binds to cell receptors where GH would normally bind,     thus preventing the naturally occurring hormone from stimulating IGF-1 and bone growth as it     normally would. This study will see if pegvisomant will reduce blood levels of IGF-1 and     mitigate the effects of growth hormone excess, including bone pain, bone turnover, hand and     foot swelling and sweating, and abnormal levels of related hormones.      Patients who were screened for polyostotic fibrous dysplasia and MAS under NIH protocol     98-D-0145 and were found to have MAS with excess growth hormone are eligible for this 36-week     study. The screening protocol includes a history and physical examination, blood and urine     tests, hearing, eye and dental examinations, pain and physical function evaluations,     endocrine and bone screening tests, various bone imaging studies, including magnetic     resonance imaging (MRI) and computed tomography (CT) scans and bone biopsy in patients over 6     years old.      Participants in the current study will receive daily injections of either pegvisomant or     placebo (an inactive substance) for 12 weeks, followed by a 6-week washout period with no     drug. Then, patients who received placebo will be switched, or crossed over, to receive     pegvisomant for another 12 weeks, and those who received pegvisomant will receive placebo.     This will be followed by another 6-week washout period. The drug and placebo will be injected     under the skin, similar to insulin injections. Blood and urine tests will be done at the     beginning of the study and repeated every 6 weeks until the study ends.   "
166671|NCT00017940|"     This Phase I clinical trial is the first step in testing gene therapy. This study is called a     Safety/Toxicity study by the Food and Drug Administration, and primarily aims to determine     whether the experimental protocol is safe for humans. It will determine whether the study     procedure causes side effects in humans, and may also give us a preliminary sense of whether     this will be effective in combating Alzheimer's disease in humans.   "
166672|NCT00017953|"     The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term     effects of a lifestyle intervention designed to achieve and maintain weight loss. The study     will investigate the effects of the intervention on heart attacks, stroke and     cardiovascular-related death in individuals with type 2 diabetes who are also overweight or     obese.   "
166673|NCT00017966|"     This study will use transcranial magnetic stimulation to examine how the brain controls     movement by sending messages to the spinal cord and muscles and what goes wrong with this     process in disease. Normal healthy volunteers 18 years of age and older may be eligible to     participate.      In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp     or skin. Brief electrical currents are passed through the coil, creating magnetic pulses that     stimulate the brain. During the stimulation, participants will be asked to tense certain     muscles slightly or perform other simple actions. The electrical activity of the muscle will     be recorded on a computer through electrodes applied to the skin over the muscle. In most     cases, the study will last less than 3 hours.   "
166674|NCT00017979|"     This study will use transcranial magnetic stimulation to examine how the brain controls     movement by sending messages to the spinal cord and muscles and what goes wrong with this     process in disease. Normal healthy volunteers between the ages of 18 and 65 years may be     eligible to participate.      In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp     or skin. Brief electrical currents are passed through the coil, creating magnetic pulses that     stimulate the brain. During the stimulation, participants will be asked to tense certain     muscles slightly or perform other simple actions. The electrical activity of the muscle will     be recorded on a computer through electrodes applied to the skin over the muscle. In most     cases, the study will last less than 3 hours.   "
166675|NCT00017992|"     The purpose of this study is to see if emtricitabine is safe in children infected with HIV     and to determine the best dose.   "
166676|NCT00018005|"     This study will test whether a self-management (SM) intervention, compared to usual care,     will reduce the risk for adverse clinical outcome in patients with mild to moderate heart     failure.   "
166677|NCT00018018|"     This study will evaluate a new method for delivering gene transfer therapy to patients with     severe combined immunodeficiency disease (SCID) due to a defective adenosine deaminase (ADA)     gene. This gene codes for the adenosine deaminase enzyme, which is essential for the proper     growth and function of infection-fighting white blood cells called T and B lymphocytes.     Patients who lack this enzyme are vulnerable to frequent and severe infections.      Some patients with this disease receive enzyme replacement therapy with weekly injections of     the drug PEG-ADA (ADAGEN). This drug may increase the number of immune cells and reduce     infections, but it is not a cure. Gene transfer therapy, in which a normal ADA gene is     inserted into the patient s cells, attempts to correct the underlying cause of disease. This     therapy has been tried in a small number of patients with varying degrees of success. In this     study, the gene will be inserted into the patient s stem cells (cells produced by the bone     marrow that mature into the different blood components white cells, red cells and platelets).      Patients with ADA deficiency and SCID who are taking PEG-ADA and are not candidates for     HLA-identical sibling donor bone marrow transplantation may be eligible for this study.      Participants will be admitted to the NIH Clinical Center for 2 to 3 days. Stem cells will be     collected either from cord blood (in newborn patients) or from the bone marrow. The bone     marrow procedure is done under light sedation or general anesthesia. It involves drawing a     small amount of marrow through a needle inserted into the hip bone. The stem cells in the     marrow will be grown in the laboratory and a normal human ADA gene will be transferred into     them through a special type of disabled mouse virus. A few days later, the patient will     receive the ADA-corrected cells through an infusion in the vein that will last from 10     minutes to 2 hours.      Patients will be evaluated periodically for immune function with blood tests, skin tests, and     reactions to tetanus, diphtheria, H. influenza B and S. pneumoniae vaccinations. The survival     of ADA-corrected cells will be monitored through blood tests. The number and amount of blood     tests will depend on the patient s age, weight and health, but is expected that blood will     not be drawn more than twice a month. Patients will also undergo bone marrow biopsy aspirate     (as described above) twice a year. Patients will be followed once a year indefinitely to     evaluate the long-term effects of therapy.   "
166678|NCT00018031|"     This study will evaluate the safety and effectiveness of combination therapy with     peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in     HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus     ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is     a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b.     This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher     blood concentration and thus maintaining activity against the hepatitis C virus.      HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a     viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates     will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is     not available. The liver biopsy is done to determine the severity of liver disease. For this     test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is     injected into an arm vein, the skin in the area over the biopsy site is numbed with a local     anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small     tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray,     electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening     tests, candidates who appear eligible for the study will have a physical examination, medical     history and repeat blood tests. Women who can become pregnant will have serial pregnancy     tests throughout the study.      Patients who meet the study criteria and decide to participate will begin treatment with     weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a     day by mouth. In addition, patients will continue to take all other medications prescribed by     their doctor. Clinic visits will be scheduled as follows:        -  Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood          levels of HIV and HCV.        -  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests          will be done to determine the side effects of treatment and its effect on the HCV          infection.        -  Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or          earlier for those who do not complete the 48 weeks, patients will return to the clinic          for a routine test.   "
166685|NCT00018122|"     This grant is to study patients that have received a kidney transplant AND an Islet Cell     transplant and to discover how the transplant is functioning. We will seek to have several     patients who have had a kidney transplant but do NOT have either type of diabetes. These     patients will serve as the control group since they will also be on immunosuppressive     medications but are not affected by abnormal blood sugars. This will allow investigators to     develop an understanding of how these immunosuppressive medications affect glucose metabolism     (blood sugar levels) and insulin utilization (how the body uses insulin).   "
166761|NCT00019201|"     RATIONALE: Fluorescent bronchoscopy, when used in combination with conventional white light     bronchoscopy, may improve the ability to detect early lung cancer.      PURPOSE: A pilot study to evaluate fluorescent light bronchoscopy plus conventional     bronchoscopy as a tool for screening and detecting lung cancer in persons with completely     resected head and neck cancer or successfully treated early-stage lung cancer.   "
166679|NCT00018044|"     This study will examine the symptoms, course of disease and treatment of non-tuberculous     mycobacterial (NTM) infections, as well as the genetics involved in these infections.     Patients with NTM have recurrent lung infections and sometimes infections of the skin and     other organs as well. They may also have curvature of the spine, barrel chest, and heart     valve weakness. The study will compare the features of NTM with those of Job syndrome and     cystic fibrosis, other diseases involving recurrent infections of the lungs and possibly     other organs.      Patients with diagnosed or suspected non-tuberculous mycobacterial infection, cystic fibrosis     or Job syndrome may be eligible for this study. All participants will have a medical and     family history, blood and urine tests, imaging studies that may include X-rays, computed     tomography (CT) or magnetic resonance imaging (MRI) scans, and DNA and other genetic studies.     In addition, all patients with Job syndrome and cystic fibrosis, and patients with NTM who     have lung disease undergo the following procedures:        -  Scoliosis survey X-rays of the spine to look for curvature or other abnormalities of the          spinal column        -  Echocardiography imaging test that uses sound waves to examine the heart chambers and          valves        -  Electrocardiogram measurement of the electrical activity of the heart        -  Pulmonary function tests breathing tests to measure how much air the patient can move          into and out of the lungs        -  Body measurements measurements of height, weight, arm span, finger length, etc.        -  Joint function assessment of joint mobility using different maneuvers to test          flexibility of joints and ligaments        -  Examination of physical features that might be associated with NTM, such as high arched          palate of the mouth, flat feet, or certain skin features        -  Dermatology (skin) examination for reactive skin conditions or other skin problems and          possibly a skin biopsy (surgical removal of a small skin tissue sample for microscopic          examination)        -  Interview with genetics specialist      These tests may require several days to complete. Patients with NTM will also be examined by     a cystic fibrosis specialist and may have a sweat test. In addition, NTM patients will be     asked to return to NIH every year for 5 years for follow-up tests, if medically indicated,     including CT of the chest, scoliosis survey and examination by other specialists.   "
166680|NCT00018057|"     This study uses functional magnetic resonance imaging (fMRI) to learn how the brain functions     in adolescents receiving fluoxetine (Prozac) cognitive behavioral therapy (CBT) or     interpersonal therapy (IPT) for anxiety or depression in children/adolescents.      All participants will receive interviews to assess how they are doing in general, including     general mood, degree of nervousness and behavior. Each participant and one of his or her     parents will be interviewed separately and together. Those electing the medication study will     also receive a physical examination. Participants are asked to complete tasks involving     problem-solving and memory that involve looking at pictures, remembering things, testing     reaction times, and making simple choices.      Participants with anxiety or depression will first meet with a psychiatrist or psychologist     for two weekly sessions of talk therapy.      Those who remain anxious or depressed after these 2 weeks will have the 3 options based on     their choice: 1) treatment with fluoxetine daily for 8 weeks 2) cognitive-behavioral therapy     or interpersonal therapy (two kinds of talk therapy) once a week for 8 weeks 3) a random     assignment (50% chance) to either placebo or fluoxetine for 8 weeks. In addition, subjects     also will be randomly and blindly assigned to receive either an active computer-based     training task or an inactive computer-based training task, administered as part of the     other,along with their medication or talk -therapy treatment. The active training is thought     to help anxiety whereas the inactive training is thought to have no effect. The purpose of     this part of the study is to understand the best way to help children and adolescents who are     having problems with anxiety. However, more research is needed to find the best way to help     such children and adolescents. During and after the 8 weeks of treatment, each participant     will complete verbal and written symptom ratings. Blood samples will be drawn for laboratory     tests before drug treatment and after it ends.      Those who have not improved by the end of the study will be offered other treatment for 1 to     3 months, and the clinicians will help with finding subsequent aftercare. Those who improve     with treatment will continue therapy at NIH until an outside physician is able to assume     responsibility for monitoring medication.      FOR MORE INFORMATION REGARDING THIS STUDY CALL THE CORE PHONE NUMBER: 301-496-5645   "
166681|NCT00018070|"     This study will try to identify and treat feeder vessels in age-related macular degeneration.     The macula is the part of the retina in the back of the eye that determines central or best     vision. In macular degeneration, leaking blood vessels under the macula lead to loss of     central vision. These vessels branch out tree-like from one or more feeder vessels. Instead     of treating all the abnormal branching vessels, this study will try to find and close only     the feeder vessels, thereby depriving the abnormal vessels of nutrition. The vessels will be     closed with laser beam treatment.      People 50 years of age and older with macular degeneration and visual acuity worse than 20/50     in the study eye and the same or better vision in the other eye may be eligible for this     study. Candidates will undergo fluorescein angiography to try to locate feeder vessels. For     this procedure, a yellow dye is injected into an arm vein. The dye travels to the blood     vessels in the eyes, and pictures of the retina are taken using a camera that flashes a blue     light into the eye. The pictures show if any dye has leaked from the vessels into the retina,     indicating possible blood vessel abnormality.      Before laser treatment, participants will have a complete eye examination, including     measurement of visual acuity, evaluation of the front part of the eye with a slit lamp     microscope, examination of the retina with an ophthalmoscope, and measurement of eye pressure     using a tonometer.      During the laser treatment phase of the study, participants will have indocyanine green     angiography-a procedure similar to fluorescein angiography, but using a green dye-to     photograph the retina and identify feeder vessels. If feeder vessels are located, laser beam     treatment will begin. For this procedure, the eye is anesthetized with numbing drops. A     special contact lens is then placed on the eye for the laser treatment. The number of     treatments depends on how well the individual patient responds, but usually between two and     eight treatments are required.      The indocyanine green angiogram will be repeated after the laser beam treatment to determine     if the feeder vessels have been successfully closed. If the vessels remain partially open, a     repeat application will be done, followed by another indocyanine green angiogram to check the     results.      Patients will be checked in the clinic after 1 week to see if additional treatment is needed.     If so, re-treatment will be done in a week. If no re-treatment is required, follow-up visits     will be scheduled 2, 3, and 6 weeks after treatment, 3 and 6 months after treatment, and     every 6 months after that for 2 years to evaluate treatment results. The evaluations will     include fluorescein angiograms and other examinations that were done before starting     treatment. If abnormal vessels are still present or growing, repeat treatments will be     applied following the same procedure.   "
166682|NCT00018083|"     The primary objective of this multi-center sub-study of USPHS Study 23: Intensive     Pharmacokinetic Study of Intermittent Rifabutin and Isoniazid with Daily Efavirenz in     Combination with Two Nucleoside Analogs for Treatment of HIV and Tuberculosis Co-infections,     is to compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with     efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without     efavirenz. Secondary objectives are: (1) To describe pharmacokinetics of both rifabutin and     efavirenz in combination regimen, (2) To evaluate the safety of concomitant efavirenz and     rifabutin, (3) To assess the effect on absolute neutrophil count by changing rifabutin dose     and adding efavirenz to the regimen, (4) To develop models of optimal sampling times for     rifabutin dosed twice a week, (5) To describe the pharmacokinetics of isoniazid in     combination with efavirenz daily with two NRTIs, (6) To compare the pharmacokinetics of     isoniazid with and without efavirenz.   "
166683|NCT00018096|"     In this project, we hypothesize that polymorphisms of genes expressed by the airway epithelia     in asthmatics following specific airway challenges predispose individuals to the development     of asthma. To test this hypothesis, we identify the genes that are differentially expressed     by airway epithelial cells following challenge with stimuli that induce acquired (house dust     mite) or innate (LPS) immune responses, and then determine whether polymorphisms in these     genes are associated with the development of asthma in a separate, well characterized,     familial cohort of asthmatics. This is a powerful approach that is designed to identify novel     genes that are associated with both asthma pathogenesis (differentially expressed in the     exposure-response study) and asthma susceptibility (genetically associated with asthma in a     linkage/association study).   "
166684|NCT00018109|"     To establish a collaborative group of clinical trial centers, with standardized equipment and     protocols, able to conduct both drug and gene therapy trials in DMD. To evaluate the     therapeutic effect of glutamine and creatine monohydrate on muscle strength in children with     DMD. To validate the use of QMT (quantitative muscle strength testing) and gait analysis in     children with DMD as reliable tools to quantify muscle strength, monitor disease progression     and assess therapeutic response.   "
166923|NCT00012064|"     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune     response to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients     who have stage IV or recurrent melanoma.   "
166686|NCT00018135|"     Patients on hemodialysis tend to have chronic elevations in the level of phosphorus in the     blood and a secondary increase in the iPTH level. This chronic elevation in iPTH can have     adverse consequences, thus a variety of phosphate binders are given in an attempt to decrease     the absorption of phosphorus present in the normal diet. Some preliminary studies have     indicated that the iPTH level may change based on the amount of phosphorus present in a meal     prior to any significant absorption of phosphorus. If this is true in hemodialysis patients,     then the timing of the administration of phosphate binders in relation to the ingestion of     meals needs to be considered   "
166687|NCT00018148|"     Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco     withdrawal symptoms and increases long term cessation rates when combined with transdermal     nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized,     parallel group trial in which smokers aged 18-70 will be subject to the combination of oral     and patch treatments.   "
166688|NCT00018161|"     This protocol evaluates the efficacy of combining pharmacologic treatments for smoking     cessation, entailing the use of the nicotine skin patch with the nicotinic antagonist     mecamylamine, with a specific behavioral therapy designed to inhibit the smoking urge.   "
166689|NCT00018174|"     This project is a treatment-matching study to test whether adding antidepressant     pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's     ability to quit, while not undermining cessation goals for the smoker who lacks a history of     depression. The study target is to randomize 120 smokers with a prior history of depression     and 120 smokers who lack such a history to a double-blind treatment with either 60 mg     fluoxetine or placebo, while they undergo cognitive behavioral treatment to quit smoking.   "
166690|NCT00018187|"     The purpose of this study is to test the effectiveness of a combination of the drugs     bupropion and mecamylamine along with a nicotine patch as a therapy for smoking cessation.   "
166691|NCT00018200|"     The purpose of this study is to determine whether different types of antidepressant medicines     relieve back pain that has lasted at least six months on a daily basis. Study participants     will be assigned to treatment with either a antidepressant acting on the serotonin system in     the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control     medication not expected to relieve pain (benztropine). Each participant will be seen at least     nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.   "
166692|NCT00018213|"     The aim of this study is to investigate the effects of naltrexone, alone and combined with     nicotine patch, on responses of smokers to smoking cues after 10 hours of tobacco     deprivation. Smokers who are not seeking treatment will be assigned to one of six conditions:     They will receive either 50 mg of naltrexone or a placebo pill, and also will wear a nicotine     patch that has 0, 21, or 42 mg of nicotine during the tobacco deprivation period. Both the     day before the medication and deprivation and at the end of 10 hours of deprivation all will     be exposed to lit cigarette cues in the laboratory. Effects of the medications will be     assessed on withdrawal measures, urge to smoke, psychophysiological measures, and the     topography of smoking three test cigarettes. Studies such as these can help to identify     potential interventions for tobacco cessation or withdrawal, and thereby could result in less     suffering and mortality.   "
166693|NCT00018226|"     The purpose of this project is to assess whether enhanced outreach counseling (EOC) is an     effective outreach strategy for discharged methadone maintenance patients compared to a     standard referral procedure. EOC is a brief (30 minute) face-to-face intervention, followed     by six weeks of ongoing telephone counseling/case management designed to help eligible     out-of-treatment methadone patients re-enter treatment. Several studies have shown those     patients who voluntarily re-enter treatment improve significantly following re-enrollment.   "
166694|NCT00018239|"     This study will determine whether the metabolic and cellular mechanisms contributing to     improved insulin action after aerobic or resistive exercise are different in older, obese,     insulin resistant veterans. The hypothesis is that regular exercise, whether aerobic or     resistive, will improve whole body insulin action, but the nature and magnitude of changes in     skeletal muscle will differ between the two types of exercise.   "
166695|NCT00018252|"     Coronary artery disease (CAD) remains the leading cause of death in the elderly. Silent     myocardial ischemia (SI) is a manifestation of CAD in which there is a transient alteration     in myocardial perfusion, function, and/or electrical activity not accompanied by chest pain.     Mental and emotional stress, in particular hostility and anger are potent inducers of SI,     Individuals with SI are at a 3-5 fold higher risk for the development of angina, myocardial     infarction and death than subjects without SI.   "
166696|NCT00018265|"     The purpose of this study is to examine the impact of aerobic fitness on the ability of able     and disabled older adults to perform daily functional activities. Subjects are tested in     their oxygen use patterns as they perform a series of functional tasks (such as walking on     stairs) and following a 24-week training program focused on improving the ability to perform     daily tasks likely requiring aerobic fitness (such as walking on stairs).   "
166697|NCT00018278|"     The main purpose of this study is to determine the electrophysiological effects of     cholinergic therapy (cholinesterase inhibitors and transdermal nicotine) in Alzheimer     disease. The attempt will be to locate electrophysiological markers and predictors of     cognitive and clinical treatment response.   "
166698|NCT00018291|"     This study is aimed at investigating specific pharmacological interventions in the treatment     of the disruptive, agitated behavior associated with Alzheimer's patients. In addition, it is     hoped that specific clinical profiles will be found to predict which treatment is most     effective for these particular patients.   "
166699|NCT00018304|"     The overall objective of this proposal is to examine the contribution of changes in total     body fat, enhancement in insulin-mediated vasodilatation and enhancement in     endothelium-derived nitric oxide production to the improvements in metabolic insulin action.     In addition, the study will track whether these improvements are related to changes in blood     pressure.   "
166729|NCT00018694|"     The treatment of cerebrotendinous xanthomatosis an in born error of bile acid synthesis with     chenodeoxycholic acid. Patients with this disease over produce cholestanol and bile acid     precursors because of the block in synthesis. Replacement with chenodeoxycholic acid shut     down abnormal pathway and reduces elevated level of cholestanol and improves the clinical     syndrome.   "
166700|NCT00018317|"     This study will examine the effects of long-term adherence to a low protein diet (LPD) of 0.6     g/kg-1/d-1 with and without progressive resistance exercise training in patients with     impaired renal function on body composition, renal function (glomerular filtration rate),     nitrogen balance, muscle strength and size, and functional capacity. The hypothesis is that     adherence to a LPD will result in a reduction in skeletal muscle mass and reduced strength     and functional capacity while those patients who adhere to the LPD and exercise will     demonstrate a similar preservation of renal function but will have greater fat free mass,     muscle mass and strength. The intervention trial will last 18 months in which patients with     moderate renal failure will be randomly assigned to one of 4 interventions: standard care,     standard care + exercise, LPD, and LPD with exercise. In this way the independent and     combined effects of diet and exercise on the progression of renal disease and body     composition will be monitored. This study will have important implications for the treatment     of patients with chronic renal failure. New strategies of combining exercise with     recommendations of a low protein diet may slow the progression of renal disease and improve     strength and functional capacity in these at-risk patients.   "
166701|NCT00018330|"     This study is designed to determine whether sequence variation in the lipoprotein lipase     (LPQ) gene affects the amount of weight loss and metabolic responses during a hypocaloric     diet treatment for overweight and obese (BMI=25-35 kg/m2), older (50-65 yrs), sedentary     veterans.   "
166702|NCT00018343|"     This study is designed to evaluate the potential beneficial effects of estrogen on cognitive     function of women with Alzheimer's Disease.   "
166703|NCT00018356|"     This study's primary objective is to determine the independent and combined effects of     progressive resistance muscle strength training and testosterone on the development of     sustainable improvements in physical function.   "
166704|NCT00018369|"     Studies investigating physiological processes involved in aging-related deficits in     regulation of stress hormone systems.   "
166705|NCT00018382|"     This study examines the use of insulin-sensitizing compounds, as therapeutic agents for     cognitive impairment in Alzheimer's disease.   "
166706|NCT00018395|"     The purpose of this cohort study is to estimate the risk of cardiovascular mortality     associated with abnormal calcium metabolism   "
166707|NCT00018408|"     The purpose of this study is to determine whether genetic factors contribute to an     individuals risk of developing obstructive lung disease from smoking cigarettes.   "
166708|NCT00018421|"     This randomized trial investigates the hypothesis that regular aerobic exercise training     using a task specific gait training modality will improve cardiovascular fitness, functional     mobility, and reduce risk factors for recurrent cardiovascular events in chronic hemiparetic     stroke patients, when compared to matched controls performing just stretching.   "
166709|NCT00018434|"     Current projects study veteran patients with chronic ulcers and MRSA colonization and     infection, patients with imipenem-resistant P. aeruginosa colonization and infection, the     relationships between staffing pattern, severity of illness and nosocomial infections in     intensive care units and infection control practices for veteran patients with suspected     tuberculosis.   "
166710|NCT00018447|"     This study is designed to determine if combining parathyroid (PTH 1-34) with fluoride (MFPSR)     therapy in a cyclic treatment regimen will: (1) produce a greater increase in bone density of     the spine than would be produced by either treatment alone; (2) prevent the resistance (i.e.,     decreased bone formation and no further increase in bone density) that is observed within     18-24 months of PTH therapy; (3) eliminate the calcium deficiency and osteomalacia that can     occur with fluoride; (4) prevent excessive bone fluoride content; and (5) result in an     increase in bone density which is maintained after treatment is discontinued.   "
166711|NCT00018460|"     Determine whether low or high dose B vitamin therapy will lower homocysteine and     thrombomodulin in patients anticoagulated with warfarin.   "
166712|NCT00018473|"     This study will create Alzheimer 's disease risk profiles for defined combinations of     genotypes and environmental exposures. This study will carry out a molecular epidemiologic     study to identify genetic and environmental risks factors using state of the art techniques.     The following will be done during the course of this study 1) Recruit both Alzheimer's     patients and cognitively normal aged veterans. 2) Evaluate gene interaction in Alzheimer's     disease. 3) Evaluate gene-environment interactions on the risk of Alzheimer's disease. These     procedures should initially address the question as to whether certain genes either     independently or synergistically modify the risk of Alzheimer's disease. This study will also     determine whether certain environmental factors (smoking, alcohol consumption etc.) can     modify the risk of AD and whether this effect is dependent on certain genetic backgrounds.     This study will provide information that will be useful in designing therapies, develop risk     factor profiles to be further tested in future studies, designating patients for specific     therapies based on genetic factors and providing data and genetic material for future     studies. This study will also provide a cohort of older and well characterized cognitively     normal veterans for prospective genetic epidemiological studies on aging.   "
166713|NCT00018486|"     The purpose of this study is to determine if individuals with diabetes are at increased risk     of hearing impairment or tinnitus (the perception of ringing or noises in the ears or head).     An important goal of this research is also to obtain a better understanding of possible     interactions between hearing disorders and other chronic conditions, such as diabetes.     Participation in this research will be for a few hours only, to be scheduled at the     participant's convenience and according to the testing schedules of the different clinics     involved.   "
166714|NCT00018499|"     Genetic differences in response to brain injury may reasonably be expected to play a role in     the initial consequences of traumatic brain injury and in the rate of recovery from such     injury.   "
166730|NCT00018707|"     This is the follow-up to an observational epidemiological study of psychological and     neuropsychological outcomes of deployed and non-deployed Gulf War-era veterans.   "
166778|NCT00019500|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of raloxifene may be an effective way to prevent     breast cancer in premenopausal women.      PURPOSE: Phase II trial to study the effectiveness of raloxifene in preventing invasive     breast cancer in premenopausal women.   "
166715|NCT00018512|"     The primary term goal of these research efforts has been to enhance the functional status,     comfort and quality of life of edentulous patients by evaluating clinical procedures, denture     designs and adjunctive therapies based upon a clear understanding of: (1) oral functional     impairments caused by the loss of teeth and subsequent tissue changes; (2) neurophysiological     mechanisms associated with oral functions; (3) metabolism of oral tissues; and (4)     interactions between biological and psychological processes and denture characteristics. The     primary purpose of the proposed clinical outcome study is to compare the relative efficacies     of three different combinations of implant-supported maxillary and mandibular prostheses with     traditional complete dentures for edentulous patients. Completion of this study will     determine the relative cost-effectiveness of the implant-supported denture treatments for use     in the general population of edentulous patients.   "
166716|NCT00018525|"     The main objectives of this study are to see if a type of lung surgery, known as lung     reduction surgery, in addition to standard medical treatment improves the quality of life,     lung function, and reduces the high mortality associated with severe emphysema when compared     to standard medical treatment alone. Another goal of this study is to better identify the     patients most likely to benefit from this surgical treatment. The information obtained in     this study is important because lung reduction surgery is being done in several centers     around the country but its long term benefits, if any, over standard medical treatment, are     not known.   "
166717|NCT00018538|"     Prostate cancer is a common occurrence in the aging population, with one in ten men destined     to develop the disease. 40% of patients with prostate cancer experience a recurrence after     definitive treatment. This study addresses the as-yet unresolved problem of the optimal     management of early recurrence as manifested by increase in the accepted marker for this     disease, PSA. Vitamin D, an agent with cell-differentiating properties, has been shown to     inhibit angiogenesis and cause differentiation of prostate cancer cells in the laboratory and     to affect PSA favorably in clinical studies of patients with advanced prostate cancer. This     study will assess the effects of vitamin D in patients with sub-clinical biochemical relapses     of prostate cancer as indicated by rising PSA but low tumor burdens, with the potential for     developing an approach to this problem that will delay or prevent progression.   "
166718|NCT00018551|"     Colorectal neoplasia is the second most common cancer in the United States and other Western     countries with about 140,000 newly diagnosed cases per year in the United States with a     mortality rate of about 40%. The identification of a specific natural or synthetic compound     with the ability to reverse or suppress the process of colon carcinogenesis would have     profound implication in the development of colorectal adenomas and their subsequent     transformation to colon cancer. Furthermore, the establishment of a correlative relationship     between biomarkers of cell proliferation, differentiation, apoptosis and adenoma recurrence     would provide pivotal data required to elucidate cell signaling mechanisms in future colon     cancer chemoprevention trials.   "
166719|NCT00018564|"     This clinical research program is designed to evaluate medications as new treatments for     essential tremor. Essential tremor is a common condition with few available therapies.   "
166720|NCT00018577|"     This program aims to investigate factors associated with development of parkinsonism or     idiopathic Parkinson's Disease in an ongoing cohort of patients established in 1965 who are     currently undergoing their sixth examination.   "
166721|NCT00018590|"     This is a working registry of a longitudinal cohort of Hispanics, Native Americans, and     non-Hispanic whites (as controls) for tracking of vascular disease endpoints. Blood samples     collected for ongoing pilot projects as well as specimen banking. Pilot studies are     observational and involve risk measures for stroke, atherosclerosis, and vascular     inflammatory responses. Questionnaires on demographics, risk factors, and vascular disease     history are performed. No interventions proposed as yet.   "
166722|NCT00018603|"     This is a double-blind, placebo-controlled, randomized study lasting 8 weeks. Purpose of the     study is two-fold: first, to use a pharmacological agent to treat symptoms of PTSD, and     second, to explore neurobiological mechanisms of action of guanfacine.   "
166723|NCT00018616|"     This is a randomized controlled trial of adherence. The study involves monitoring and     managing focused intervention in patients prescribed metformin.   "
166724|NCT00018629|"     The purpose of this study is to determine if Cognitive - Behavioral Social Skills Training     (CBSST) improves functioning in older patients with schizophrenia.   "
166725|NCT00018642|"     The purpose of this research study is to determine whether a new drug for schizophrenia is     better for the maintenance treatment than a standard drugs currently prescribed. The new     medication is called quetiapine and it will be compared with a standard medication called     haloperidol decanoate. The study will determine if quetiapine causes fewer problems than     haloperidol with side effects such as stiffness and restlessness and whether it costs the VA     more or less to treat patients with quetiapine. In addition, blood samples will be collected     every three months to determine if certain chemicals in the blood can influence the outcome     of the subjects' illness.   "
166726|NCT00018655|"     This study is a randomized clinical trial comparing outcomes of Integrated Cognitive     Behavioral Treatment plus standard medications for veterans with both substance use     disorders, depressive disorders versus the most commonly administered form of therapy for     substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group     treatment plus medications.   "
166727|NCT00018668|"     Motor slowing is a hallmark, clinical sign in mental illness. Slowness can be related to a     specific disease process, as in negative schizophrenia or depression or it can be the result     of medications used to treat forms of mental illness. Prior research has lead to a novel     instrumental approach for distinguishing subtypes of motor slowing - one type related to     cognitive processes and another related to parkinsonism. The purpose of this study is to test     whether new medications used to treat schizophrenia improve the cognitive or parkinsonian     components of motor slowing. Patients will be studied in the laboratory before and 8-weeks     after starting a new antipsychotic. The n of this study = 60 patients. The results of this     study will improve our understanding of the complex interactions between cognitive processing     and motor behavior in patients with psychotic illnesses and how drugs work to treat these     problems.   "
166728|NCT00018681|"     This study investigates distribution and regulation of bile acid transport in the human     intestine.   "
166731|NCT00018720|"     The purpose of this study is to determine how people with high triglycerides metabolize and     absorb bile acids, compounds made in the body from cholesterol.      This project has two objectives: A) To define the mechanism of impaired bile acid absorption     in hypertriglyceridemia (specifically we will determine if the active or passive component of     absorption is abnormal) and B) to determine the contribution of an alternative pathway of     bile acid synthesis which begins with 27-hydroxylation of cholesterol. Because 27-hydroxylase     is present in endothelial cells as well as liver, this pathway may play a role in removal of     cholesterol from incipient atherosclerotic plaque.   "
166732|NCT00018733|"     This study will be measuring changes in depressive symptoms over a 7 week time period.     Double-blind placebo controlled trial using the pharmacologic agents Paroxetine or     Desipramine.   "
166733|NCT00018746|"     The study examines efficacy of repetitive transcranial magnetic stimulation in treating     severely depressed patients who are medicated.   "
166734|NCT00018759|"     This study aims to determine if treatment with an SSRI antidepressant medication, paroxetine,     is associated with cellular calcium response to serotonin, platelet serotonin receptors, and     improvement in mood in depressed patients with or without hypertension. It is hypothesized     that platelets of hypertensive patients with depressive symptomatology with be     hyper-responsive to serotonin. Additionally, treatment with an SSRI antidepressant is     expected to produce a down-regulation of the serotonin receptor with an associated reduction     in platelet cytosolic calcium response as well as improved mood.   "
166735|NCT00018772|"     Deep venous thrombosis is the presence of blood clots, usually in the legs that lead to     either local problems or breathing problems if the clot moves to the lungs. This study is     designed to assess both clinical conditions as well as common genetic factors that lead to     more risk of deep venous thrombosis. Clinical conditions of venous thrombosis include:     stroke, malignancy, and situations such as surgery, pregnancy, trauma, or travel.   "
166736|NCT00018785|"     Diabetes and end-stage kidney, liver and heart disease are prominent health issues among     veteran patients. Successful solid organ transplantation in the absence of chronic     immunosuppressive therapy (specific acquired immunological tolerance) is a desirable     therapeutic option. This project extends recent observations supporting the use of     concommitant donor bone marrow cell infusion as a means of modulating the immune response in     kidney transplantation, thereby allowing a substantial decrease or withdrawal of potentially     toxic immunosuppressive drugs.   "
166737|NCT00018798|"     The primary goals for this investigation are to quantify: (1) fluctuations in PTSD symptom     reports when assessed at bi-weekly intervals; (2) change in PTSD symptoms associated with     stressful life events; and (3) change in PTSD symptoms associated with perceived social     support.   "
166738|NCT00018811|"     Subjects with chronic migraine or tension headaches will receive 12 sessions of biofeedback     or relaxation training after fulfilling screening, intake interviews, & psychological testing     requirements. They will chart headache pain, anger level, & medication usage throughout     baseline, treatment, and 3 month follow-up periods.      Migraine sufferers will receive a combination of progressive muscle relaxation training and     thermal biofeedback (learning to warm hands). Subjects are randomly assigned to receive     treatment either in the office with the therapist or from another room (where communication     will be over a computer). The research is designed to compare the effectiveness of treatment     based on location.      Tension headache sufferers will receive training in how to reduce their muscle tension     levels. They will be randomly assigned to have equipment monitor muscle tension levels either     in the forehead or shoulder regions. The research is designed to compare the effectiveness of     feedback to the forehead versus the shoulder muscles.   "
166739|NCT00018824|"     The purpose of this study is to test the efficacy combining a treatment for depression with a     treatment for alcohol dependence.   "
166740|NCT00018837|"     The goal of this research program is to implement a series of psychoeducational training     classes designed to teach individuals with schizophrenia the importance of medication     treatment, how to identify and manage medication side effects, and how to make appointments     and emergency plans. The skills taught to the research subjects will lead to demonstrable     increases (compared to the control group) in adherence to both the prescribed medication     regimen and scheduled outpatient appointments and thereby cause a decrease (again compared to     the control group) in rehospitalization rates and bed-days during subsequent twelve months     following the intervention. A secondary objective of this work is that if the CREP program is     successful and/or illness education is effective, the data will be able to disseminated     throughout the VISN 22 via the recently awarded Mental Illness Research Education and     Clinical Center (MIRECC) program.   "
166741|NCT00018850|"     The target groups in this study are brain waves and neurotransmitters (chemical messengers)     in the brain. Subjects with diagnosed with schizophrenia will be studied. The study will help     understand more about normal brain functioning and how that functioning differs in people     with schizophrenia. Another purpose of this study is to determine how the altered brain     functioning in schizophrenia contributes the symptoms found in the illness.   "
166742|NCT00018863|"     This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in     very young children. The medication being used is methylphenidate (Ritalin); it is being     studied to determine its safety and how well it works to treat ADHD in preschool-age children     (3-5.5 year olds).   "
166743|NCT00018876|"     More than 10,000 people each year in the United States have failed back surgery syndrome     caused by scars that form around the outer surface of the spinal cord. Such scarring, known     as peridural fibrosis, is common after back surgery known as either lumbar discectomy or     laminectomy. Peridural fibrosis may cause recurring low back pain or leg pain after surgery.     Operating again to remove the scar tissue often leads to more scarring.      Researchers have not previously studied radiation as a way to prevent peridural fibrosis. We     will test whether low-dose radiation given 24 hours before surgery will decrease the amount     of peridural fibrosis and if this reduction will lead to improved results of surgery. Half of     the participants will receive radiation before surgery and the other half will not. We will     evaluate patients at followup visits 1, 3, 6, and 12 months after surgery with a physical     exam and questionnaire. At 12 months, we will obtain magnetic resonance imaging (MRI) of the     lower spine.   "
183281|NCT00242437|"     Evaluating clinical performance of Hemostatic Matrix with bovine thrombin in achieving     hemostasis in patients undergoing endoscopic sinus surgery.   "
166744|NCT00018889|"     The goal of this protocol is to identify families with inherited movement disorders and     evaluate disease manifestations to establish an accurate clinical diagnosis by using newest     technological advances and investigate the underlying molecular mechanisms. Studies of     inherited movement disorders in large families with good genealogical records are especially     valuable. Patients with diseases of known molecular basis will be genotyped in order to     investigate phenotype/genotype correlation. Patients with disease of unknown or incomplete     genetic characterization will be studied with a hope of contributing to the identification of     specific disease-causing genes and genetic mechanisms responsible for a specific disorder.   "
166745|NCT00018902|"     The purpose of the study is to determine how best to treat adolescents with depression that     is resistant to the first SSRI antidepressant they have tried. Participants receive one of     three other antidepressant medications, either alone or in combination with cognitive     behavioral therapy.   "
166746|NCT00018941|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. It     is not yet known which regimen of interleukin-2 is most effective for kidney cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of     interleukin-2 in treating patients who have metastatic kidney cancer.   "
166747|NCT00018954|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of two treatment regimens for patients in     developing countries with diffuse non-Hodgkin's lymphoma and acute lymphoblastic leukemia.   "
166748|NCT00018967|"     RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from     the toxic effects of chemotherapy.      PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous     system toxic effects in patients given an accidental overdose of intrathecal methotrexate.   "
166749|NCT00019006|"     RATIONALE: Vaccines made from mutated ras peptides may make the body build an immune response     to and kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of a vaccine containing mutated ras     peptides and an immune adjuvant in treating patients who have colon, pancreatic, or lung     cancer.   "
166750|NCT00019019|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of     carboxyamidotriazole and paclitaxel in treating patients with advanced solid tumors or     refractory lymphomas.   "
166751|NCT00019032|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have chronic lymphocytic leukemia.   "
166752|NCT00019058|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     pentoxifylline and hydroxyurea may make tumor cells more sensitive to radiation therapy.      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus pentoxifylline     and hydroxyurea in treating patients who have high-grade astrocytoma or glioblastoma.   "
166753|NCT00019071|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of cladribine followed by radiation therapy     in treating patients who have malignant glioma.   "
166754|NCT00019084|"     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make     the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's     white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an     effective treatment for advanced cancer.      PURPOSE: Phase II trial to study the effectiveness of a vaccine made with the patients' white     blood cells mixed with tumor proteins in treating patients who have advanced cancer.   "
166755|NCT00019097|"     RATIONALE: Vaccines made from a person's tumor cells may make the body build an immune     response and kill their tumor cells. Peripheral stem cell transplantation may be able to     replace immune cells that were destroyed by chemotherapy used to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation     plus vaccine therapy and chemotherapy in treating patients who have multiple myeloma.   "
166756|NCT00019110|"     RATIONALE: Vaccines made from certain human papillomaviruses may be able to help the body to     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of human papillomavirus vaccine therapy in     treating patients who have advanced or recurrent cancer of the cervix, vagina, penis, anus,     esophagus, or head and neck.   "
166757|NCT00019123|"     RATIONALE: Thalidomide may kill cancer cells by stopping the growth of new blood vessels to     the tumor.      PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients with     HIV-associated Kaposi's sarcoma.   "
166758|NCT00019136|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill ovarian cancer     cells. Interleukin-2 combined with white blood cells that are gene-modified to recognize and     kill ovarian cancer cells may be an effective treatment for recurrent or residual ovarian     cancer.      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 plus gene-modified white     blood cells in treating patients who have advanced ovarian epithelial cancer.   "
166759|NCT00019175|"     RATIONALE: Vaccines made from an antigen combined with a modified virus may make the body     build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white     blood cells to kill melanoma cells. Combining vaccine therapy with interleukin-2 may kill     more tumor cells.      PURPOSE: Phase I trial to compare the effectiveness of vaccine therapy with or without     interleukin-2 in treating patients who have recurrent metastatic melanoma that has not     responded to previous therapy.   "
166760|NCT00019188|"     RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by     stimulating a person's white blood cells to kill their tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of interleukin-12 in treating patients     with AIDS -related Kaposi's sarcoma.   "
166762|NCT00019214|"     RATIONALE: Vaccines made from white blood cells treated with antigens may make the body build     an immune response to kill melanoma cells. Interleukin-2 may stimulate a person's white blood     cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may kill more     melanoma cells.      PURPOSE: This phase I/II trial is studying the side effects and how well giving vaccine     therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with     metastatic melanoma that has not responded to previous therapy.   "
166763|NCT00019227|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus     pentetic acid calcium in patients with leukemia.   "
166764|NCT00019240|"     RATIONALE: Herpesvirus is found in Kaposi's sarcoma lesions in most patients; it is therefore     possible that the herpesvirus has a role in causing Kaposi's sarcoma. Cidofovir is an     antiviral drug that acts against many types of herpesvirus, and may be an effective treatment     for Kaposi's sarcoma.      PURPOSE: Phase II trial to study the effectiveness of cidofovir in treating patients with     Kaposi's sarcoma with or without HIV infection.   "
166765|NCT00019318|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of depsipeptide in treating patients who     have solid tumors for which no standard therapy exists.   "
166766|NCT00019331|"     RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill     tumor cells. Combining vaccine therapy with interleukin-2 and/or sargramostim may be a more     effective treatment for solid tumors.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2     and/or sargramostim in treating adults who have metastatic solid tumors.   "
166767|NCT00019344|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of flavopiridol in treating patients who     have refractory cancer.   "
166768|NCT00019357|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.     Combining white blood cells, which have been activated by a vaccine, with interleukin-2 may     kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 plus activated white blood     cells in treating patients with cancer that has not responded to chemotherapy or radiation     therapy.   "
166769|NCT00019383|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving     the vaccine with interleukin-2 or sargramostim may help kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of peptide vaccine with or without     adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory     metastatic melanoma.   "
166770|NCT00019396|"     RATIONALE: The drug flt3L may stimulate a person's immune system and help to kill tumor     cells. Vaccines made from melanoma cells may make the body build an immune response to and     kill their tumor cells.      PURPOSE: Phase II trial to study the effectiveness of flt3L with or without vaccine therapy     in treating patients with metastatic melanoma or renal cell cancer.   "
166771|NCT00019409|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. Giving radiation therapy to the head or intrathecal chemotherapy may prevent cancer     cells from spreading to the brain. It is not yet known which treatment regimen is more     effective for acute lymphoblastic leukemia.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the     head or intrathecal chemotherapy plus high dose cytarabine in preventing CNS disease in     children who have acute lymphoblastic leukemia.   "
166772|NCT00019422|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Lobradimil may increase the effectiveness of a chemotherapy drug by     making tumor cells more sensitive to the drug.      PURPOSE: Phase II trial to study the effectiveness of carboplatin and lobradimil in treating     children with brain tumors that have not responded to previous treatment.   "
166773|NCT00019435|"     RATIONALE: The LMB-9 immunotoxin may be able to locate tumor cells and kill them without     harming normal cells. This may be an effective treatment for advanced solid tumors.      PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients     who have advanced solid tumors that have not responded to standard therapy.   "
166774|NCT00019448|"     RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor     cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.     Combining vaccine therapy and interleukin-2 may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy with or without     interleukin-2 in treating patients with metastatic melanoma that has not responded to     previous treatment.   "
166775|NCT00019461|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole in treating     patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary     peritoneal cancer.   "
166776|NCT00019474|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.     Colony-stimulating factors such as filgrastim may increase the number of immune cells found     in bone marrow or peripheral blood and may help a person recover from the side effects of     chemotherapy. Combining chemotherapy with interferon alfa may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and interferon     alfa followed by filgrastim in treating patients who have gastrointestinal tract cancer.   "
166777|NCT00019487|"     RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune     response and kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients     who have metastatic melanoma that has not responded to previous therapy.   "
166928|NCT00012142|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase II trial to determine the effectiveness of CCI-779 in treating     patients who have progressive prostate cancer.   "
166781|NCT00019552|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have     recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.   "
166782|NCT00019565|"     RATIONALE: Diagnostic procedures, such as PET and MRI scans, may help to measure a patient's     response to treatment.      PURPOSE: This diagnostic trial is studying how well PET and/or MRI scans work in assessing     changes in tumor blood supply in patients receiving antiangiogenesis therapy.   "
166783|NCT00019578|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I     trial to study the effectiveness of stereotactic radiosurgery in treating patients who have     brain tumors.   "
166784|NCT00019591|"     RATIONALE: Vaccines may make the body build an immune response that will kill cancer cells.     Combining vaccine therapy with interleukin-2 may kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without     interleukin-2 in treating patients who have locally advanced or metastatic colorectal cancer.   "
166785|NCT00019604|"     RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above     body temperature and may kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating     patients who have unresectable primary or metastatic liver cancer.   "
166786|NCT00019630|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of liposomal doxorubicin in treating     children who have refractory solid tumors.   "
166787|NCT00019643|"     RATIONALE: Chemotherapy may affect various factors that can lead to weight gain.      PURPOSE: Clinical trial to evaluate factors that may affect weight gain in women receiving     adjuvant chemotherapy for stage I, stage II, or stage IIIA breast cancer.   "
166788|NCT00019656|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have     refractory solid tumors or hematologic cancer.   "
166789|NCT00019669|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not     yet known whether combining melanoma vaccine with interleukin-2 is more effective than     vaccine therapy alone in treating metastatic melanoma.      PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2     with that of melanoma vaccine alone in treating patients who have metastatic melanoma that     has not responded to previous treatment.   "
166790|NCT00019682|"     This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it     works compared to aldesleukin alone in treating patients with melanoma that has spread from     where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin     may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body     build an immune response to kill tumor cells. It is not yet known whether combining     aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating     melanoma.   "
166791|NCT00019695|"     RATIONALE: Ketoconazole may suppress the production of hormones and may interfere in the     growth of prostate cancer cells. Alendronate sodium may be effective in preventing bone     metastases and bone pain associated with prostate cancer. It is not known if ketoconazole is     more effective with or without alendronate sodium.      PURPOSE: Randomized phase II trial to study the effectiveness of ketoconazole with or without     alendronate sodium in treating patients who have metastatic prostate cancer.   "
166792|NCT00019708|"     Phase I trial to study the effectiveness of geldanamycin analogue in treating patients who     have advanced solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy work in     different ways to stop tumor cells from dividing so they stop growing or die.   "
166793|NCT00019721|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining     vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.      PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without     interleukin-2 in treating patients who have metastatic melanoma that has not responded to     previous therapy.   "
166794|NCT00019734|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with and     without interleukin-2 in treating patients who have metastatic melanoma that has not     responded to previous treatment.   "
166795|NCT00019747|"     RATIONALE: Thalidomide may stop the growth of colorectal cancer by stopping blood flow to the     tumor. Giving thalidomide after surgery may kill any remaining tumor cells.      PURPOSE: This randomized phase II trial is studying surgery and thalidomide to see how well     they work compared to surgery alone in treating patients with recurrent or metastatic     colorectal cancer.   "
166796|NCT00019760|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving them in different ways may     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of melphalan given as an isolated hepatic     perfusion followed by chemotherapy infused into the liver in patients who have unresectable     colorectal cancer that is metastatic to the liver.   "
166929|NCT00012155|"     RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the safety of NV1020 in patients who have colon cancer that     has spread to the liver and has not responded to previous chemotherapy.   "
166797|NCT00019773|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin with capecitabine     in treating patients who have colorectal, appendix, or small bowel cancer.   "
166798|NCT00019786|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving drugs in different ways may kill more tumor cells.      PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan     works in treating patients with primary unresectable liver cancer or liver metastases.   "
166799|NCT00019812|"     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and deliver     tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use     different ways to make tumor cells stop dividing so they stop growing or die. Combining     monoclonal antibody therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus paclitaxel in treating     patients who have metastatic breast cancer that overexpresses HER2.   "
166800|NCT00019825|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients who have     unresectable lung or esophageal cancer or malignant mesothelioma of the pleura.   "
166801|NCT00019838|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from     dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when     given with UCN-01 in treating patients with recurrent or refractory low-grade lymphoma or     leukemia.   "
166802|NCT00019864|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it     can be removed during surgery. Giving chemotherapy after surgery may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving chemotherapy before and after     surgery works in treating patients with osteosarcoma.   "
166803|NCT00019890|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating     patients who have high-risk stage III or completely resected metastatic melanoma.   "
166804|NCT00019916|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. It is not yet     known whether combining vaccine therapy with interleukin-2 is effective in treating breast     and ovarian cancer.      PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and     interleukin-2 and to see how well they work in treating women with stage IV, recurrent, or     progressive breast or ovarian cancer.   "
166805|NCT00019929|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: This phase II trial is studying vaccine therapy given after standard therapy to see     how well it works in treating patients with stage III non-small cell lung cancer.   "
166806|NCT00019955|"     RATIONALE: Radiofrequency interstitial tissue ablation may kill tumor cells by heating tumors     to several degrees above body temperature.      PURPOSE: This phase II trial is studying radiofrequency interstitial tissue ablation to see     how well it works in treating patients with localized renal cell carcinoma (kidney cancer).   "
166807|NCT00019968|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Infusing melphalan directly to the tumor may kill more tumor cells     and cause less damage to healthy tissues. It is not yet known whether melphalan plus tumor     necrosis factor is more effective than melphalan alone for soft tissue sarcoma.      PURPOSE: Randomized phase II trial to study the effectiveness of isolated limb perfusion of     melphalan with or without tumor necrosis factor in treating patients who have soft tissue     sarcoma of the arm or leg.   "
166808|NCT00019994|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients     who have metastatic melanoma that has not responded to previous therapy.   "
166809|NCT00020007|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Heating paclitaxel to several degrees above body temperature and     infusing it to the affected area around the tumor may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel given by     hyperthermic perfusion in treating patients with lung cancer or lung metastases that cannot     be removed by surgery.   "
166810|NCT00020046|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping     blood flow to the tumor.      PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel with or without     thalidomide in treating patients who have metastatic prostate cancer.   "
166811|NCT00020072|"     RATIONALE: Analyzing genes that are present in cancer cells may be useful in developing     better methods to detect, predict, and treat cutaneous T-cell lymphoma.      PURPOSE: Clinical trial to study genes that are present in cutaneous T-cell lymphoma cells.   "
166812|NCT00020098|"     RATIONALE: Increasing knowledge about the complementary or alternative medicine practices     used by women who are at increased risk for breast cancer may provide useful information for     planning breast-cancer-prevention strategies.      PURPOSE: Clinical trial to determine how many women who are at increased risk for breast     cancer use complementary or alternative medicine.   "
166813|NCT00020111|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from     dividing so they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide in     treating young patients with leukemia or lymphoma.   "
166814|NCT00020124|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving drugs in different ways may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients     who have advanced solid tumors affecting the lungs.   "
166815|NCT00020150|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and     O6-benzylguanine in treating children who have solid tumors that have not responded to     previous therapy.   "
166816|NCT00020176|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy used to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of allogeneic peripheral stem cell     transplantation in treating patients who have stage IV breast cancer.   "
166817|NCT00020189|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who     have recurrent or metastatic head and neck cancer.   "
166818|NCT00020202|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have     refractory or progressive small cell lung cancer or non-small cell lung cancer.   "
166819|NCT00020254|"     RATIONALE: Vaccines made from prostate cancer cells may make the body build an immune     response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase     the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may     stimulate a person's white blood cells to kill prostate cancer cells. Androgens can stimulate     the growth of prostate cancer cells. Hormone therapy using nilutamide may fight prostate     cancer by reducing the production of androgens. It is not yet known which treatment regimen     is more effective for treating prostate cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus     sargramostim and interleukin-2 with that of nilutamide alone in treating patients who have     prostate cancer that has not responded to hormone therapy.   "
166820|NCT00020267|"     RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill     tumor cells.      PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating     patients who have metastatic cancer that has not responded to previous therapy.   "
166821|NCT00020332|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating     patients who have locally advanced or metastatic breast cancer.   "
166822|NCT00020345|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving the drugs in different ways, such as directly into the     abdomen, and combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation     therapy plus surgery in treating patients who have advanced cancer of the pancreas.   "
166823|NCT00020358|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine     therapy may be an effective treatment for melanoma.      PURPOSE: Randomized phase II trial to study the effectiveness of three vaccine therapy     regimens in treating patients who have melanoma.   "
166824|NCT00020371|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have     cancers that have not responded to previous therapy.   "
166825|NCT00020397|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating     patients who have refractory metastatic melanoma.   "
166826|NCT00020410|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell     transplantation may allow the doctor to give higher doses of monoclonal antibody therapy and     kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody     followed by peripheral stem cell transplantation in treating patients who have relapsed or     metastatic breast cancer.   "
166827|NCT00020449|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood     flow to the tumor and by stimulating a person's white blood cells to kill the tumor cells.     Combining chemotherapy with interleukin-12 may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with     interleukin-12 in treating patients who have AIDS-related Kaposi's sarcoma.   "
166828|NCT00020462|"     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune     response to kill tumor cells. Combining vaccine therapy with interleukin-2 may be a more     effective treatment for follicular lymphoma .      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus interleukin-2 in     treating patients who have stage III, stage IV, or recurrent follicular lymphoma.   "
166829|NCT00020475|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining     vaccine therapy with interleukin-2 may be a more effective treatment for metastatic melanoma     of the eye.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy and interleukin-2 in     treating patients who have metastatic melanoma of the eye.   "
166830|NCT00020488|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating     patients who have advanced solid tumors.   "
166831|NCT00020501|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving them in different ways may     kill more tumor cells. It is not yet known which chemotherapy regimen is most effective for     colorectal cancer that has spread to the liver.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without isolated hepatic perfusion with melphalan in treating patients who have     colorectal cancer that has spread to the liver.   "
166832|NCT00020527|"     RATIONALE: Giving caspofungin acetate may be effective in preventing or controlling fever and     neutropenia caused by chemotherapy or bone marrow transplantation.      PURPOSE: Clinical trial to study the effectiveness of caspofungin acetate in treating     children who have fever and neutropenia caused by a weakened immune system.   "
166833|NCT00020540|"     RATIONALE: Biological therapies such as flt3L and CD40-ligand use different ways to stimulate     the immune system and stop cancer cells from growing. Biological therapy may be an effective     treatment for metastatic melanoma and metastatic kidney cancer.      PURPOSE: Phase I trial to study the effectiveness of flt3L combined with CD40-ligand in     treating patients who have metastatic melanoma or metastatic kidney cancer.   "
166834|NCT00020553|"     RATIONALE: A videotape support program may help families improve communication and coping     skills when a parent is diagnosed with cancer.      PURPOSE: Randomized trial to study the effectiveness of a video support program for families     who have a parent who has been newly diagnosed with cancer.   "
166835|NCT00020566|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Peripheral stem cell transplantation may allow the doctor to give higher doses of     chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is     more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.      PURPOSE: This randomized phase III trial is studying different combination chemotherapy     regimens to see how well they work when given with or without peripheral stem cell     transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.   "
166836|NCT00020579|"     RATIONALE: MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for     their growth.      PURPOSE: This phase I trial is studying the side effects and best dose of MS-275 in treating     patients with advanced solid tumors or lymphoma.   "
166837|NCT00020605|"     RATIONALE: Naloxone may be effective in treating constipation that may be caused by opioid     pain medications such as morphine.      PURPOSE: Phase III trial to determine the effectiveness of naloxone in relieving constiption     in patients who are receiving opioids for chronic pain.   "
166838|NCT00020618|"     RATIONALE: Morphine that is inhaled may be more rapidly absorbed than morphine that is given     by mouth. It is not yet known if inhaled morphine is more effective than morphine given by     mouth in relieving breakthrough pain.      PURPOSE: Randomized phase II trial to compare the effectiveness of inhaled morphine with that     of morphine given by mouth in treating cancer patients who have breakthrough pain.   "
166839|NCT00020631|"     RATIONALE: Pirfenidone may prevent or lessen fibrosis caused by radiation therapy.      PURPOSE: Pilot trial to study the effectiveness of pirfenidone in preventing or lessening     fibrosis in patients who have undergone radiation therapy for cancer.   "
166840|NCT00020644|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of gemcitabine given as a continuous     infusion in treating patients who have advanced metastatic cancer.   "
166841|NCT00020657|"     RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients     being treated with chemotherapy.      PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs     work in preventing delayed nausea after chemotherapy in patients who have cancer.   "
166842|NCT00020670|"     The prognosis for children and adults with acute lymphoblastic leukemia (ALL) has improved     significantly over the years. Nevertheless, patients who experience disease relapse or     induction failure along with patients having unfavorable genetics [t(4;11) or t(9;22)] have     dismal prognosis. For these patients, novel therapeutic approaches such as immunotherapy are     needed. In this clinical trial, investigators evaluate whether it is feasible to make a     vaccine from leukemia cells and whether this vaccine enables direct immunity against cancer     cells in patients.   "
166843|NCT00020683|"     COL-3 may stop the growth of cancer by stopping blood flow to the tumor. Randomized phase II     trial to compare the effectiveness of two different regimens of COL-3 in treating patients     who have HIV-related Kaposi's sarcoma.   "
166844|NCT00020696|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining tirapazamine with cisplatin     in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.   "
166845|NCT00020709|"     Randomized phase III trial to compare the effectiveness of combination chemotherapy plus     radiation therapy with or without gefitinib in treating unresectable stage III non-small cell     lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Biological therapies such as gefitinib may interfere with the growth of the tumor cells and     slow the growth of tumors. It is not yet known whether combination chemotherapy plus     radiation therapy is more effective with or without gefitinib in treating non-small cell lung     cancer   "
166846|NCT00020722|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     plus biological therapy may allow the doctor to give higher doses of chemotherapy drugs and     kill more tumor cells.      PURPOSE: This phase II trial is studying how well chemotherapy followed by peripheral stem     cell transplantation plus biological therapy works in treating women with stage IV breast     cancer.   "
166847|NCT00020735|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using     toremifene may fight prostate cancer by reducing the production of androgens.      PURPOSE: Randomized phase II trial to study the effectiveness of toremifene followed by     radical prostatectomy in treating patients who have stage I or stage II prostate cancer.   "
166848|NCT00020748|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of epirubicin plus irinotecan in treating     patients who have advanced cancer.   "
168825|NCT00047450|"     The purpose of this study is to evaluate the safety and effectiveness of citalopram (Celexa)     for the treatment of depressive symptoms in middle-aged and elderly patients with     schizophrenia.   "
166849|NCT00020761|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and paclitaxel in     treating patients who have metastatic or recurrent cancer of the esophagus or stomach.   "
166850|NCT00020774|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of SCH 66336 with or without     gemcitabine followed by surgery with that of surgery alone in treating patients who have     primary liver cancer.   "
166851|NCT00020787|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs     used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy and     chemotherapy in treating patients who have metastatic or locally recurrent stomach cancer or     esophageal cancer.   "
166852|NCT00020800|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different way to stop cancer cells from dividing so they stop growing or     die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating     patients who have Waldenstrom's macroglobulinemia.   "
166853|NCT00020826|"     RATIONALE: Assessing quality of life in patients who are undergoing cancer treatment may help     determine the effect of treatment on these patients.      PURPOSE: Clinical trial to study the effectiveness of a quality of life assessment in     patients who are receiving treatment for stomach cancer.   "
166854|NCT00020839|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It     is not yet known if chemotherapy is more effective with or without radiation therapy in     treating brain metastases.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or     without radiation therapy to the brain in treating patients who have stage IV melanoma with     asymptomatic brain metastases.   "
166855|NCT00020852|"     RATIONALE: Cryosurgery kills cancer cells by freezing them. Cryosurgery followed by     lumpectomy or mastectomy may be an effective treatment for breast lesions.      PURPOSE: Phase I trial to study the effectiveness of cryosurgery in treating women who have     breast lesions.   "
166856|NCT00020865|"     RATIONALE: Levofloxacin may be effective in reducing fever and controlling other symptoms of     neutropenia in patients who are being treated for cancer. It is not yet known whether     levofloxacin is more effective than cefepime in reducing fever and controlling symptoms of     neutropenia.      PURPOSE: Randomized phase III trial to compare the effectiveness of levofloxacin with that of     cefepime in reducing fever and controlling symptoms of neutropenia in patients who are being     treated for cancer.   "
166857|NCT00009529|"     To examine the effects of rigid gas permeable contact lenses on the progression of myopia     (nearsightedness) in children      To determine what changes in the eyes cause certain eyes to progress in nearsightedness more     slowly   "
166858|NCT00009542|"     This study will examine how kava-a widely used herbal remedy-may affect the body's     elimination of other medicines. Many people take kava to reduce anxiety or cause sedation.     Since this product is considered a food supplement and not a drug, it is not subject to the     rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a     result, information has not been collected on possible interactions between kava and other     medications. This study will look at how kava affects the elimination of caffeine-a compound     commonly found in chocolate, coffee, tea and soft drinks-and dextromethorphan-an OTC cough     suppressant.      Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study.     Candidates will provide a medical history and undergo a physical examination and routine     blood tests. Women of childbearing age will have a urine pregnancy test.      Study participants will not drink alcoholic beverages or take any medications (except those     given in the study) for 2 weeks prior to the study and throughout its duration. In addition,     they will abstain from caffeine, grapefruit and grapefruit juice and charbroiled foods for at     least 72 hours before and throughout each study day that urine is collected.      On day 1 of the study, study subjects will take one dose each of caffeine and     dextromethorphan at 4:00 P.M.. They will empty their bladder before the dosing and then     collect all their urine after the dosing for the rest of the day and including the next     mornings first urine. They will bring the urine samples to the Clinical Center when the     collection is complete. This procedure will be repeated 1 week later (study day 8). After the     second urine collection is completed, subjects will take 200 milligrams of kava 3 times a day     for 21 days. On study day 29 (after 21 days of kava), subjects will repeat the     dextromethorphan and caffeine dosing and urine collection described above, while continuing     to take kava.      Subjects will have an electroencephalograph (EEG) done before starting kava and again at the     end of kava (study day 30). For this procedure, several electrodes (metal cups attached to     wires) are secured to the scalp with a glue-like substance. A conductive gel fills the space     between the electrode and the scalp to ensure good contact. The electrodes will remain in     place for about 2 hours and then removed. The subject lies quietly on a bed during the EEG     recording.      Participation in the study will end with another physical examination and blood tests     following the second EEG and urine collection.   "
166859|NCT00009555|"     The purpose of this study is to see if treatment with testosterone will reduce abdominal fat     in HIV-positive men.      Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have     shown that treatment with testosterone may decrease abdominal fat. This study will determine     if testosterone will reduce abdominal fat in HIV patients.   "
166860|NCT00009568|"     This study will examine the effect of a class of antidepressant medications called selective     serotonin reuptake inhibitors (SSRIs) on platelet function. Platelets are small blood cells     that help stop bleeding after injury to a blood vessel by forming a clot, or plug, in the     vessel. Some medications impair platelet function, leading to increased bruising and     bleeding. SSRIs decrease an important platelet component called serotonin, which may cause     bleeding in some patients. SSRIs include fluoxetine (Prozac), sertraline (Zoloft), paroxetine     (Paxil), fluvoxamine (Luvox) and citalopram (Celexa).      Patients 18 years of age and older being treated for depression with a SSRI or the non-SSRI     bupropion (Wellbutrin) may be eligible for this study. Subjects will be recruited from a     private clinic in Washington, D.C.      Participants will provide a history of their current medications and past history of     bleeding. They will have about 4 tablespoons of blood drawn for tests to measure blood cell     counts and platelet function. The study takes about 1 hour. The results of the SSRI-treated     group and the bupropion-treated group will be analyzed and compared.      This study may provide information that will help health care providers make treatment     decisions to minimize possible adverse effects of medications in patients with depression.   "
166882|NCT00009880|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy and radiation therapy may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy     plus radiation therapy with and without fluorouracil in treating patients who have cancer of     the esophagus or stomach.   "
166883|NCT00009893|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have unresectable or metastatic biliary tract or gallbladder cancer.   "
166861|NCT00009581|"     Nitric oxide is important in regulating blood vessel dilation, and consequently, blood flow.     This gas is continuously produced by cells that line the blood vessels. It is also     transported from the lungs by hemoglobin in red blood cells. This study will examine how this     gas regulates blood vessels and blood flow in people with sickle cell anemia. It will also     look at a possible benefit of using certain genetic information to compare the white blood     cells of people with sickle cell anemia to those without the disease.      Patients with sickle cell anemia and healthy normal volunteers 18 to 65 years of age may be     eligible for this study. Candidates will be screened with a medical history, cardiovascular     physical examination, electrocardiogram and routine blood tests. Participation of volunteers     without sickle cell anemia will be limited to a single blood draw for genetic study. Sickle     cell disease patients will undergo the following procedures:      Patients will lie in a reclining chair during the study. After administration of a local     anesthetic, small tubes will be inserted through a needle into the artery and vein of the     patient's forearm. These are used to measure blood pressure and draw blood samples during the     study. Forearm blood flow will be measured using pressure cuffs placed on the wrist and upper     arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are     inflated, blood flows into the arm, stretching the strain gauge, and the flow measurement is     recorded. A small lamp will be positioned over the hand. Light reflected back from the hand     provides information about nitric oxide and hemoglobin in the blood of the skin. A squeezing     device called a dynamometer will be used to measure handgrip strength.      Baseline blood flow, nitric oxide, hemoglobin, and handgrip will be measured after an     infusion of glucose (sugar) and water. These measurements will be repeated at various times     before, during and after administration of small doses of the following drugs:        -  Sodium nitroprusside - causes blood vessels to dilate and increases blood flow to the          heart        -  Acetylcholine - causes blood vessels to dilate and slows heart rate        -  LNMMA - decreases blood flow by blocking the production of nitric oxide      There will be a 20- to 30-minute rest period between injections of the different drugs.      When the above tests are completed, the patient will breathe a mixture of room air and nitric     oxide for 1 hour through a facemask placed over the face, after which forearm blood flow and     light reflected from the hand will be measured. Then the patient will do the handgrip     exercise for 5 minutes, after which blood flow and hand lamp measurements will be taken.     After a 20-minute rest period (with continued breathing of room air/nitric oxide), L-NMMA     will be infused again. The handgrip exercise, blood flow and hand lamp measurements will be     repeated. The face mask will then be removed, and the tubes will be removed 20 minutes later.      Blood samples will be collected at various times during the 5- to 6-hour study through the     tubes in the arm. Some of the blood will be used to look at genes that make proteins involved     in cell-to-cell communication, inflammation, and in making red and white blood cells stick to     the lining of blood vessels.   "
166862|NCT00009594|"     Temporomandibular disorders (TMD) are characterized by pain and tenderness in the muscles of     mastication and/or the temporomandibular joint (TMJ), limitations of jaw opening often     accompanied by deviations in mandibular path, and clicking, popping or grating TMJ sounds.      TMD is often found in association with other problems: depression, anxiety, sleep     disturbances, gastrointestinal symptoms, frequent infections, etc. This project proposes to     holistically address patient symptoms through three different approaches, Naturopathic     Medicine (NM), Traditional Chinese Medicine (TCM), and usual care at KPNW. We will conduct a     pilot test and Phase II trial to evaluate the two alternative healing approaches, TCM (n=50)     and NM (n=50) delivered by TCM and NM practitioners, are as effective as usual TMD care     (n=50) provided by dental clinicians in the KPNW TMD Clinic. Subjects will be females 25-55     years of age with multiple health problems (defined as patients who have had at least 4 organ     system-grouped diagnoses in the past year, not including TMD). Subjects will be evaluated at     baseline, 6 and 12 months after start of treatment. The primary endpoint is change from     baseline in the Axis II Pain Related Disability and Psychological Status Scale. Clinical     examinations, saliva samples to assess salivary cortisol levels, and responses to a series of     questionnaires to assess pain, chronic pain, psychosocial functioning, and other physical     symptoms will be used to assess outcomes. We will passively monitor health care utilization     within KPNW using clinical, research, and administrative databases to determine whether the     interventions have an impact on overall health care utilization. If either of these     alternative interventions is shown to merit Phase III trial, our goal is to design and     implement such a clinical trial to further evaluate the health consequences and costs of     these alternative healing paradigms.   "
166863|NCT00009620|"     This large randomized trial tested whether phenobarbital given to a pregnant woman about to     deliver a premature infant would prevent brain injuries in their newborns. Women with 24 to     32 week fetuses who were in preterm labor and were expected to deliver within 24 hrs were     randomized to phenobarbital or usual care. They were treated until they deliver or the fetus     reaches 33 wks gestation. Babies were followed until discharge and evaluated at 18-22 mos     corrected age for neurodevelopmental outcome.   "
166864|NCT00009633|"     The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which     surviving extremely low birth-weight infants born in participating network centers receive     neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age     (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding     pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential     maternal and neonatal risk factors that may affect infant neurodevelopment.   "
166865|NCT00009646|"     This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999     grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy     or developmental problems at 18 to 22 months of age.   "
166866|NCT00009659|"     This study will examine the safety and effectiveness of a synthetic hormone, CDB-2914, for     treating symptoms of menopause. It will compare the effects of estrogen and CDB-2914 with     those of estrogen and progesterone in postmenopausal women. The study will also evaluate     whether CDB-2914 affects adrenal gland function. CDB-2914 is chemically similar to cortisol,     a hormone that is produced by the adrenal glands and regulates the body's response to     stresses, such as infection or injury.      Healthy women volunteers between the ages of 45 and 70 who have not had a menstrual period     for over a year, are not currently taking hormone replacement therapy, do not smoke and have     not had a hysterectomy may be eligible for this study. Candidates will provide a medical     history and have a physical examination, including a breast and pelvic exam. They will also     provide a blood sample, have a mammogram and pap smear, and be instructed in dietary sources     and/or supplements required to be sure they consume at least 1,000 mg. of calcium each day.      Participants will be randomly assigned to take: a) estrogen plus CDB-2914, b) estrogen plus     progesterone, or c) estrogen plus a placebo (look-alike tablet with no active ingredient)     daily by mouth for 6 weeks. During the study period, they will keep a record of any symptoms,     vaginal bleeding, and other medicines they take. They will return to the NIH Clinical Center     weekly for blood tests and to fill out a questionnaire on mood, appetite, sleep patterns,     menopausal symptoms, and other quality of life issues. At the 6-week visit, participants     will:        -  Bring a 24-hour urine collection        -  Have a vaginal ultrasound to evaluate the effects of the medication on the thickness of          the endometrium (lining of the uterus)        -  Bring all bottles of study medication for a pill count        -  Discuss any unusual or troubling symptoms with the study nurse or physician      A final visit will be scheduled 1 to 3 weeks after the 6-week visit, when participants will     turn in their calendar of daily symptoms and return unused progesterone pills.   "
166877|NCT00009815|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor     cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating     patients who have advanced solid tumors.   "
166878|NCT00009828|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of paclitaxel combined with     fluorouracil-uracil and leucovorin in treating patients who have solid tumors.   "
166879|NCT00009841|"     RATIONALE: Gene therapy may kill cancer cells by inhibiting a gene that promotes the     development and growth of cancer.      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who     have advanced head and neck cancer.   "
166880|NCT00009854|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of carmustine followed by surgery in     treating patients who have recurrent supratentorial malignant glioma or metastatic brain     neoplasm.   "
166867|NCT00009672|"     This study will test the effectiveness of two drugs-nortriptyline and MS Contin (a type of     morphine)-to treat pain caused by lumbar radiculopathy, or sciatica. Sciatica results from     damage to the lumbar nerve roots, typically causing back pain and sharp, shooting pain down     one or both legs. Although sciatica is common, there are no good treatments for it. Tricyclic     antidepressants, such as nortriptyline, and opioids, such as morphine, have been effective in     treating other kinds of pain from nerve damage.      Patients between 18 and 65 years of age who have had sciatica pain daily for at least 3     months may be eligible for this study.      Participants will provide a medical history and occupational and other social information.     They will undergo a neurological examination, routine blood tests and an electrocardiogram     and will fill out three questionnaires providing information on daily functioning and     psychological well-being.      This cross-over study consists of several parts, including a baseline study and four     different treatment regimens. During each part, patients keep a daily log in which they rate     their pain, record other procedures they undergo, such as injections and manipulations, and     record medication side effects.      In the first week of the study, patients remain on their current medications. Any     antidepressants or opioids are stopped gradually before starting the drug trials. After the     first week, patients go through the following four drug trials in random order:        1. Nortriptyline and inert placebo-Patients take nortriptyline in doses ranging from 25 mg.          to 100 mg. and an inert placebo for morphine. (An inert placebo is a dummy pill; it          looks like the test drug but has no active ingredient.)        2. MS Contin (morphine) and inert placebo-Patients take MS Contin in doses ranging from 30          mg. to 90 mg. and an inert placebo for nortriptyline.        3. Nortriptyline and MS Contin-Patients take MS Contin and nortriptyline in the same dose          ranges as for each drug alone.        4. Active placebo and inactive placebo-Patients take an active placebo-in this case          benztropine-and an inert placebo. An active placebo is a drug that does not work for the          problem being studied but whose side effects are like those of the test drug-in this          case, slight sleepiness or dry mouth. Benztropine is given at one-third the recommended          dosage.      For each drug regimen, the medication dose is increased gradually over 5 weeks until the     maximum tolerated dose is reached. At the end of each regimen, patients are taken off the     study drugs over a 12-day tapering period and are off drugs completely for another 2 days.      Patients are seen by a doctor or nurse at the 7-week point in each study period. After all     the drug trials are finished, patients repeat the questionnaires they filled out at the     beginning of the study. Patients and their doctors will be informed of the medications that     were effective in each individual's care.   "
166868|NCT00009685|"     This study will test the safety of an experimental vaccine against HIV and will examine     whether it causes an immune response to HIV virus proteins. A vaccine is given to try to     create resistance or immunity to a disease or infection. The vaccine in this study is made     from DNA (genetic material) of two HIV proteins called gag and pol. Injected into a     human, the viral DNA instructs the body to make small amounts of some HIV proteins. This     study will see if the body then creates an immune response to these proteins. Study     participants cannot catch HIV or AIDS from the DNA vaccine or proteins that may be made from     it.      Healthy normal volunteers between 18 and 60 years of age may be eligible for this study.     Candidates will provide a medical history, including information on sexual activity and drug     use. They will have a physical examination, blood tests, urine test and chest X-ray. All     candidates enrolled in the study must use a barrier method of contraception for sexual     intercourse from the start of the study until 3 months after the last vaccination.      Participants will be assigned to one of two treatment groups: one will receive the     experimental vaccine; the other will receive a control substance (inactive salt solution).     The first five people assigned to the vaccine group will receive the lowest study dose of the     vaccine. If this dose is safe, it will be increased three times for the next group of five     and then eight times for the last group of five. Each group will have a total of seven people     - five will receive the vaccine and two will get the salt solution.      Before the first injection, and possibly the second and third, a catheter (thin plastic tube)     will be placed into a vein so that treatment can be given quickly if there is a reaction to     the vaccine. Participants will receive three injections in an upper arm muscle-one injection     a month for three months-with a needle-less device called a Biojector. For each injection,     the volunteer will        -  be observed for at least 1 hour after immunization        -  record temperature and symptoms, including any effects at the injection site, for 2 days          and report them to the clinic staff        -  immediately report any side effects to a study physician or nurse.      Volunteers will have physical examinations and laboratory tests at certain times while they     receive the vaccine and for a period afterwards. These procedures will require about 14     clinic visits of about 1 to 2 hours each, and up to 6 hours on vaccination days. Blood will     be drawn at all visits. Some of the blood will be used for genetic tests, and some will be     stored for future tests of the immune system and the body's response to the study vaccine.     The study will last about 12 months from the date of the first injection. After it is     completed, clinic staff may contact volunteers once or twice a year for at least 3 years to     follow up.   "
166869|NCT00009698|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill more cancer     cells.      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating children who     have undergone bone marrow transplantation for acute myeloid leukemia.   "
166870|NCT00009711|"     RATIONALE: Assessing the long-term effects of bone marrow transplant on lung function in     patients may improve the ability to plan treatment.      PURPOSE: This clinical trial studies lung function in pediatric patients who have undergone     bone marrow transplant.   "
166871|NCT00009737|"     This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in     combination with leucovorin, in patients who have undergone surgery for colon cancer.     Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21     days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every     28 days. The anticipated time on study treatment is 3-12 months, and the target sample size     is 500+ individuals.   "
166872|NCT00009750|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining monoclonal antibody therapy and chemotherapy with peripheral stem cell     transplantation may be an effective treatment for metastatic prostate cancer.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy plus     chemotherapy followed by peripheral stem cell transplantation in treating patients who have     metastatic prostate cancer that has not responded to hormone therapy.   "
166873|NCT00009763|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Combining monoclonal antibody     therapy with cyclosporine and paclitaxel may be an effective treatment for metastatic breast     cancer.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody     therapy, cyclosporine, and paclitaxel in treating patients who have recurrent or refractory     metastatic breast cancer.   "
166874|NCT00009776|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Combining monoclonal antibody     therapy with cyclosporine and paclitaxel may be an effective treatment for non-Hodgkin's     lymphoma.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy     combined with paclitaxel and cyclosporine in treating patients who have recurrent or     refractory non-Hodgkin's lymphoma.   "
166875|NCT00009789|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy     in treating patients who have stage I non-small cell lung cancer and lung dysfunction.   "
166876|NCT00009802|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Calcitriol may increase the effectiveness of paclitaxel by making     tumor cells more sensitive to the drug.      PURPOSE: Phase I trial to study the effectiveness of combining calcitriol with paclitaxel in     treating patients who have advanced solid tumors.   "
177138|NCT00153296|"     The purpose of this study was to determine whether antiepileptic drug carbamazepine is     effective in the treatment of chronic moderate persistent and severe asthma.   "
166884|NCT00009906|"     Randomized phase III trial to compare the effectiveness of two different doses of STI571 in     treating patients who have metastatic or unresectable gastrointestinal stromal tumor. STI571     may interfere with the growth of tumor cells and may be an effective treatment for cancer. It     is not yet known which dose of STI571 is more effective in treating gastrointestinal stromal     tumors.   "
166885|NCT00009919|"     Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic     kidney cancer that has not responded to previous therapy with interleukin-2. SU5416 may stop     the growth of kidney cancer by stopping blood flow to the tumor   "
166886|NCT00009932|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining fenretinide, paclitaxel, and     cisplatin in treating patients who have solid tumors that have not responded to previous     therapy.   "
166887|NCT00009945|"     RATIONALE: Clodronate may be effective in preventing the spread of cancer to the bones and     other parts of the body. It is not yet known whether clodronate is more effective alone or     combined with chemotherapy and /or hormonal therapy in preventing metastatic breast cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of clodronate with or     without chemotherapy and /or hormonal therapy in preventing metastases in women who have     stage I or stage II breast cancer.   "
166888|NCT00009958|"     Phase I trial to compare the effectiveness of vaccine therapy with or without sargramostim in     treating patients who have solid tumors. Vaccines may make the body build an immune response     to kill tumor cells. Combining colony-stimulating factors such as sargramostim with vaccines     may kill more tumor cells.   "
166889|NCT00011583|"     Our long term objectives are to understand the mechanisms of motor impairment following     neurologic injury and to develop interventions to improve motor recovery. A series of     complementary, overlapping clinical trials and development activities will validate and     optimize the use of robot-assisted upper limb therapy for neuro rehabilitation.      We have developed a robotic system that assists or resists elbow and shoulder movements in     three dimensional space. In addition to unilateral exercise modes, a novel bimanual mode     enables hemiparetic subjects to practice mirror image upper limb exercises.   "
166890|NCT00011596|"     To date, conventional rehabilitation is not able to restore normal, safe, gait for many     individuals with stroke. We have identified nine gait component deficits which respond to the     FNS-IM intervention. This study will test a refined treatment protocol of 3 months duration     to restore volitional gait by restoring those nine gait components simultaneously. In     addition, we will incorporate into the treatment protocol a promising non-invasive technique     of partial body weight-supported (BWS) gait training on a treadmill. BWS and FNS-IM have the     potential to provide additive effects for the patient and restore volitional gait more     quickly and more completely than would otherwise be possible with one technique alone.   "
166891|NCT00011609|"     The primary purpose of this project, is to evaluate the effect of a wheelchair mounted     robotic arm (WMRA) to improve the functional independence of veterans with SCI.      The study will determine if the ability to perform marker tasks within the following four     categories is improved after the 4 week training period using the robotic arm:      1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific     tasks.   "
166892|NCT00011622|"     This proposal is a pilot study to describe the variations of blood sugar in pregnant women     with various degrees of glucose intolerance, and how they relate to standardized meals. Blood     sugar control during pregnancy is important to prevent complications for the newborn. The     variation and timing of the blood sugar measurements in gestational diabetics and how this     relates to the baby's outcome is controversial. We will use an FDA approved device called     Minimed Glucose Continuous Monitor, which is used in clinical practice for certain diabetics.     It is very small, similar to a beeper, and is connected to the patient through a small     plastic catheter subcutaneously. This measures blood sugar every five minutes for a total of     288 readings a day with minimum discomfort. The hypothesis of this study is that use of the     Minimed glucose monitor will provide information about variations of blood sugar in     gestational diabetics that is missed by capillary glucose monitors.      Our conclusions will allow us to compare blood glucose trends among the groups. After the     data is analyzed in this pilot study, we plan to design a bigger study involving more     subjects to study the impact of the blood sugar variations in the outcome of the newborn, and     to obtain generalizable results for the population in general.   "
166893|NCT00011635|"     Complementary and alternative medicines are widely used in the HIV-infected population.     Recent data have shown serious drug interactions between certain complementary medicines and     protease inhibitors. Silymarin (Milk thistle) is a commonly used dietary supplement in     HIV-infected patients for treatment of hepatitis or as a hepato-protectant. Data are     available suggesting that it may alter cytochrome P4503A4-mediated drug metabolism. To     evaluate the effect of milk thistle on the protease inhibitor, indinavir (IDV), ten healthy     subjects will receive IDV (Crixivan) alone and in combination with an over-the-counter     silymarin preparation. IDV will initially be administered alone at a dose of 800 mg Q8H for     four doses and serial samples will be collected for determination of IDV pharmacokinetics     after the morning dose on day 2. Subjects will then initiate therapy will milk thistle using     a standardized formulation and dose for three weeks after which subjects will then again take     4 doses of IDV and have serial samples collected for IDV plasma concentrations. There will     then be a 11-day washout period with no drugs, after which IDV will again be given for 4     doses and samples will be collected evaluate the offset of the effects of milk thistle. To     examine the effect of milk thistle on other CYP450 pathways, subjects will receive a single     dose of caffeine and dextromethorphan and have urine collected before and after milk thistle,     and after the washout period. Indinavir, caffeine, and dextromethorphan concentrations in     plasma or urine will be determined using validated HPLC methods. Steady-state     noncompartmental parameters of indinavir in the presence and absence of milk thistle will be     determined. Pharmacokinetic parameters will be compared using ANOVA that will include factors     for a period effect and a treatment effect. Statistical analyses will include calculation of     the mean ratio of the AUC in the treatment phases compared to IDV alone and determination of     95% confidence intervals. This study will help define the drug interaction potential of     complementary and alternative therapies in HIV-infected patients.   "
166930|NCT00012168|"     RATIONALE: New imaging procedures such as lymphoscintigraphy may improve the ability to     detect the spread of mouth and throat cancer to lymph nodes in the neck.      PURPOSE: Pilot study of lymphoscintigraphy followed by sentinel lymph node mapping and     sentinel lymph node biopsy to detect lymph node metastases in the neck in patients who have     mouth or throat cancer.   "
166931|NCT00012181|"     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Phase I trial to study the effectiveness of flavopiridol in treating children     who have relapsed or refractory solid tumors or lymphoma.   "
174890|NCT00130871|"     The study evaluates the efficacy of intravenous levosimendan treatment started during a     coronary artery bypass operation to wean patients from a heart lung machine.   "
166894|NCT00011648|"     The purpose of this study is to determine how often people with sickle cell anemia develop     pulmonary hypertension a serious disease in which blood pressure in the artery to the lungs     is elevated.      Men and women 18 years of age and older with sickle cell anemia may be eligible for this     study. Participants will undergo an evaluation at Howard University s Comprehensive Sickle     Cell Center in Washington, D.C. or at the National Institutes of Health in Bethesda,     Maryland. It will include the following:        -  medical history        -  physical examination        -  blood collection (no more than 50 ml., or about 1/3 cup) to confirm the diagnosis of          sickle cell anemia, sickle cell trait or beta-thalassemia (Some blood will be stored for          future research testing on sickle cell anemia.)        -  echocardiogram (ultrasound test of the heart) to check the pumping action of the heart          and the rate at which blood travels through the tricuspid valve.      Following this evaluation, a study nurse will contact participants twice a month for 2 months     and then once every 3 months for the next 3 years for a telephone interview. The interview     will include questions about general health and recent health-related events, such as     hospitalizations or emergency room visits.   "
166895|NCT00011661|"     The purpose of this study is to examine whether adding an inter-generational component to an     existing social network-based lay health advisor intervention increases its effectiveness in     mobilizing a Native American community to respond to heavy metal contamination from lead and     zinc mining.   "
166896|NCT00011674|"     This prospective cohort study examines the role of prenatal and early postnatal lead exposure     on the neuropsychological status and social adjustment of adolescents enrolled in the     Cincinnati Lead Study. We are examining the relationship between moderate exposure to lead     and neuropsychological deficits, difficulties in peer relationships, personality disturbances     and juvenile delinquency. This birth cohort of approximately 300 subjects has been followed     since 1980 with regularly scheduled assessments of blood lead concentrations, health history,     social and hereditary factors, and neurobehavioral development.   "
166897|NCT00011687|"     The Study for Future Families is a multi-center study that is recruiting pregnant women and     their partners in four US cities to look for differences between cities in several measures     of reproductive health. These measures include how long it took couples to conceive as well     as hormone levels and semen quality in the male partners. This study is modeled after a study     in four European cities so that,when complete, data on the 300 couples in each of the eight     cities can be compared.   "
166898|NCT00011700|"     The majority of the workscope of this project is focussed on an infant animal model of     toxigenic mold induced pulmonary hemorrhage. Clinically related studies are directed only to     the description of human infants diagnosed with idiopathic pulmonary hemorrhage regarding     their clinical parameters, and collecting samples of secretion, blood, and urine for analysis     for fungal spores and mycotoxins. These latter analyses are being developed using the infant     rat model.   "
166899|NCT00011713|"     The purpose of the study is to investigate the relationship between environmental agents and     reproductive health. Environmental agents of interest include exposure to chemicals such as     polychlorinated biphenyls (PCBs), flame retardants, dioxins, bisphenol A, phthalates,     pesticides, and metals like lead and cadmium. We are also interested in the relationship     between reproductive health and lifestyle risk factors, such as exposure to environmental     tobacco smoke. Enrollees are asked to participate in this study because they and their     partner are patients of the MGH Fertility Center, trying to get pregnant, either naturally or     by undergoing Intrauterine Insemination (IUI) and/or In Vitro Fertilization (IVF).   "
166900|NCT00011726|"     We are examining the role of maternal bone lead turnover during pregnancy and lactation as a     potential source of lead exposure for the fetus and the infant (via breast milk). A cohort,     ascertained at entry to care, consists of >1000 women to be followed through pregnancy. In     the postpartum subjects are recruited for a nested case control study to assess the influence     of lactation on maternal bone density, maternal blood lead and breast milk lead.   "
166901|NCT00011739|"     Low back pain is a frequent cause of disability and a common reason for outpatient care in     veterans. Magnetic resonance imaging (MRI) of the lower back often reveals     abnormalities,which may be used to justify expensive and invasive therapy, such as surgery.     Yet the link between MRI abnormalities and the risk of developing clinically significant back     pain is far from clear. This longitudinal study will determine the prevalence and incidence     of MRI abnormalities among veterans and determine the extent to which specific MRI     abnormalities predict future development of back pain. The result should help clinicians use     MR imaging more efficiently, and they may ultimately help reduce the frequency of unnecessary     back surgery.   "
166902|NCT00011752|"     This study uses positron emission tomography (PET) scanning to study how serotonin works in     alcoholics. Serotonin is a chemical that allows brain cells to communicate. There is evidence     that people with alcoholism have altered serotonin; their brains begin to make and break down     serotonin more slowly than people who do not drink. PET scans use radioactive substances     injected into the body. A special camera detects the radiation emitted by the radioactive     fluid and a computer processes the radioactivity into images of the brain, which show the     activity of brain chemicals like serotonin.      People with alcohol dependency may participate in this study. Candidates are screened with a     medical history, including questions about alcohol and drug use, physical examination, blood     tests, breath alcohol tests, electrocardiogram (ECG), urine test for illicit drugs and, for     women, a pregnancy test, and a stool test for hidden blood. They also undergo magnetic     resonance imaging (MRI) scan of the brain and complete questionnaires on their alcohol and     drug history.      Participants undergo the following tests and procedures:        -  Diet low in tryptophan. Tryptophan is an amino acid from which serotonin is made.        -  Brain MRI before starting the study to make sure brain structure is normal.        -  Lumbar puncture (spinal tap) to collect a small sample of cerebrospinal fluid (CSF). A          local anesthetic is given and a needle is inserted in the space between the bones          (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the          needle.        -  Arterial catheter (plastic tube) placed in an artery in the wrist area for drawing blood          samples. The skin is numbed with a local anesthetic for placement of the catheter.        -  Intravenous (IV) catheter placed in a vein for injecting the radioactive isotope used in          the PET scan.        -  Two PET scans - baseline and active.        -  Amino acid drink (orange flavored) before the active PET scan. The drink lowers          tryptophan levels.        -  Amino acid capsules - 23 amino acid capsules are taken with the orange drink.        -  Genetic analysis to help understand serotonin and alcoholism. A blood sample is          collected for DNA testing and possibly establishment of a cell line (collection of cells          that are grown in the laboratory from an original tissue specimen) for other genetic          studies.      Patients are admitted to the intensive care unit for the lumbar puncture and arterial line     procedures. After these procedures are complete, the patient is transferred by stretcher to     the PET suite for scanning. During the two scans, blood samples are drawn from the artery and     a small amount of CSF is collected each hour of the study. Each PET scanning session lasts     about 3 hours. The study lasts 36 hours, during which time the subject remains in bed.   "
166903|NCT00011765|"     This study will evaluate whether fluoxetine (Prozac), used together with traditional     psychotherapy, can reduce aggression in people who are physically violent towards their     spouses or significant others. Treatment for domestic violence has centered on behavioral     therapies, such as anger management and self-control exercises. Recent studies have shown     that fluoxetine-a drug commonly used to treat depression and panic disorder-can decrease acts     of aggression.      Men and women between the ages of 18 and 65 who have a history of inflicting physical     aggression on a spouses or significant others in the past year (with at least one episode     occurring not under the influence of alcohol) may be eligible for this study. Participants     spouses or significant others will also be asked to participate. All potential participants     will be screened with a medical and psychiatric evaluation and history, breath alcohol     analysis, blood tests, urine drug screen and electrocardiogram.      Those enrolled will undergo the following procedures:      Perpetrator        -  Interview and questionnaires - Participants will be interviewed by a social worker about          past and current mental health and use of alcohol and illicit drugs and will complete          questionnaires assessing emotional state and personality, depression, anxiety,          aggression and alcohol consumption. Some of the questionnaires will be repeated at          monthly intervals.        -  Physical performance testing - Performance and speed will be measured in three separate          training sessions that involve repeatedly pressing a button on a button box console,          earning points worth money.        -  Dyadic interaction paradigm - Participants will interact with their spouse/significant          other in a small room, first discussing a neutral topic, such as the day's events, and          then a subject that has been a source of conflict.        -  Fluoxetine administration - Participants will be randomly assigned to receive either 10          mg. of fluoxetine or placebo (identical capsules with no active ingredients) once a day          for 3 days, then twice a day, increasing up to four capsules a day if there are no          serious side effects. Blood will be drawn once a month to measure drug levels. At the          end of 3 months, participants taking placebo may remain in the study and receive          fluoxetine.        -  Clinic visits - Participants are followed in the clinic weekly for the first month, then          twice a month for the next 2 months for adjustment of number of pills, evaluation of          aggressive behavior and alcohol consumption, and therapy for issues of self-esteem,          anger management and communication skills. Couples therapy aimed at conflict resolution          and improving communication skills will be offered.        -  Genetic tests (optional) - Blood will be drawn to determine if there is a relationship          between genes involved in a chemical process (serotonin reuptake) that is influenced by          fluoxetine and the participant's response to the drug.      Spouse/Significant other:      Spouses/significant others will complete several questionnaires once a month (total 4 times)     to rate their partners' behavior while in the study. They will also participate in the dyadic     interaction paradigm described above at the beginning and end of the study.   "
166904|NCT00011778|"     This study will test the safety and effects of the experimental drug PS-341 plus radiation     therapy in patients with head and neck cancer. PS-341 can slow or halt the growth of cancer     cells grown in culture or in mice. In addition, the drug appears to enhance the effectiveness     of radiation treatment.      Patients 18 years of age and older with head and neck cancer that cannot be treated     adequately with surgery and cannot be cured with standard radiation and chemotherapy may be     eligible for this study. Patients whose cancer has spread to the brain may not participate.      Before treatment begins participants are evaluated with CT or MRI scans of the head, neck and     chest area to determine the extent of the cancer; an electrocardiogram and blood tests; and a     neurocardiovascular evaluation that includes measuring blood pressure in different body     positions and involves injections of phenylephrine and nitroglycerine. Some patients may     undergo a procedure in which a tube is inserted into the larynx (voice box), bronchi     (breathing tubes) and esophagus (food tube) and tissue samples removed. This procedure is     done under general anesthesia in the operating room.      Patients receive radiation treatments Monday through Friday and injections of PS-341 twice a     week during the radiation therapy. After 3 weeks of treatment, PS-341 injections are stopped     for 2 weeks. Some patients continue to receive radiation treatments during the 2-week break,     and others do not, depending upon when they enter the trial. The total duration of radiation     treatment varies from 6 to 8 weeks, depending on whether the patient received radiation in     the region of the head and neck cancer before entering the study.      Patients have a blood sample drawn before and after each new PS-341 injection to measure the     drug action in the blood and to see how strong and how long the effects on the blood last.     They are seen in the clinic at least once a week for a history and physical examination. A     blood sample is collected at each visit to look for toxic effects of PS-341. Near the end of     treatment, the neurocardiovascular evaluation is repeated, and if the results are abnormal,     it is repeated again 3 months after treatment is completed. X-rays or MRI scans are done 12     weeks after radiation therapy has ended and then every few months after that to determine the     extent of disease. Patients whose tumor is accessible are asked to undergo a biopsy (removal     of a small piece of tumor tissue) on the first and second day after receiving the first     PS-341 dose to examine the effect of the drug on the tumor.      The PS-341 dose is increased in successive groups of at least 3 patients until the highest     dose that can be given safely with radiation is reached. Patients who develop severe side     effects from the drug temporarily stop taking it to allow the side effects to improve. If     needed, the dose may be decreased. Radiation therapy may also be stopped temporarily in     patients who develop severe effects on the mouth, throat or skin. Side effects may be treated     with increased fluid (by mouth, stomach tube, or vein), anti-nausea or anti-diarrhea     medications, pain medications and medications to boost red or white cell counts or platelets.     The drug Florinef may be given to help regulate body fluids and blood pressure.   "
166905|NCT00011791|"     This study will examine and compare the effects of intense exercise on the release of     catecholamines in patients with congenital adrenal hyperplasia (CAH) and in healthy persons.     Catecholamines are hormones (adrenaline and noradrenaline) that are produced by the adrenal     glands and released into the blood stream during stress, such as trauma, illness, intense     exercise, or low blood sugar. The study will also assess exercise tolerance in patients with     CAH, compared with healthy persons.      Patients with CAH between the ages of 10 and 40 years who are managing well on standard     treatment (glucocorticoids, mineralocorticoids) may be eligible for this study. Healthy     volunteers that match the enrolled patients in age, sex, race and body fat will be recruited     as control subjects. All candidates will be screened with a medical history, physical     examination and electrocardiogram (EKG). Body fat will be measured using an instrument called     a Bod Pod. The body fat measurement has two parts: first, the subject sits quietly in a large     egg-shaped capsule for about 2 to 3 minutes; then the subject breathes into a plastic tube     for one minute, followed by three quick panting breaths. Women will have a urine pregnancy     test; pregnant women cannot participate in the study.      Participants will undergo three exercise sessions on separate consecutive mornings after     fasting overnight. Before each test, patients (not healthy volunteers) will take either an     additional morning dose of hydrocortisone or a placebo (a lookalike pill with no active     ingredient). Before each test a thin catheter (plastic tube) will be placed into an arm vein     through a needle. A numbing cream can be applied to make the needle stick hurt less. Blood     will be drawn through this intravenous (IV) line before, during and after the exercise tests.     The first test is a maximal exercise test to determine the individual's maximum exercise     fitness capacity. The second two and third tests are a standardized exercise tests. Before     the two standardized tests, patients (not healthy volunteers) will take either an additional     morning dose of hydrocortisone or a placebo (a lookalike pill with no active ingredient). All     tests are done on a stationary bicycle.      Maximal Exercise Test - The subject pedals on a stationary bicycle for about 10 minutes.     After a 3-minute warm-up, the workload is increased continuously until either the subject can     no longer continue or the physician stops the test for medical reasons. During the exercise,     heart rate and heart activity are monitored with an EKG, and the subject wears a nose clip     and mouthpiece connected to a breathing tube to measure oxygen use. Blood is drawn before and     during the test, totaling no more than 2 tablespoons.      Standardized Exercise Test - The subject pedals on a stationary bicycle for 20 minutes, while     wearing the nose clip and mouthpiece to measure oxygen use. For the first 5 minutes, the     subject pedals at a speed that elicits 50 percent of maximal effort (determined by the     maximal exercise test); the next 10 minutes are at 70 percent of maximal effort; and the last     5 minutes are at 90 percent. Blood samples drawn before, during (at 15 and 20 minutes) and     after exercise (at 30, 40 and 60 minutes) total less than 1/2 cup. Heart rate and heart     activity are monitored during the test with an EKG, and temperature is measured before and at     the end of the test.   "
166906|NCT00011804|"     This study will test the effectiveness of topiramate to treat pain caused by lumbar     radiculopathy, or sciatica. Sciatica results from damage to the lumbar nerve roots, typically     causing back pain and sharp, shooting pain down one or both legs. Although sciatica is     common, there are no good treatments for it. Topiramate belongs to a group of medications     commonly used to treat pain caused by nerve damage.      Patients between 18 and 75 years of age who have had sciatica pain daily for at least 3     months may be eligible for this study. (This is taken from the first paragraph of the     Qualification Criteria in the consent form. The inclusion criteria on page 6 of the protocol     say low back pain of 3 months duration or longer present at least 5 out of 7 days a week     and signs and symptoms of lumbar radiculopathy. Which is correct?)      Participants will provide a medical history, as well as occupational and social information.     They will undergo a standard neurological examination, including a test of cognitive     (thinking) abilities, muscular function, reflexes and a sensory examination. The latter     involves testing with a pin placed on the surface of the skin. Participants will also have     routine blood tests and will fill out questionnaires on their daily functioning and     psychological well being. Additional procedures may include magnetic resonance imaging (MRI)     scans and possible referral to a psychiatrist for evaluation of depression or emotional     difficulties.      This cross-over study consists of two parts. In one part, patients will receive topiramate     and in the other, an active placebo. An active placebo is a drug that does not work for the     problem being studied but whose side effects are like those of the test drug. Diphenhydramine     (Benadryl) is the active placebo used in this study. Diphenhydramine is an allergy medication     with very mild side effects, such as drowsiness. During both parts of the study-topiramate     and placebo-patients will keep a daily log in which they rate their pain, record other     procedures they undergo, such as injections and manipulations, and record medication side     effects.      In the first week of the study, patients will remain on their current medications and record     pain levels once a day. After the first week, they will begin taking the study drugs-either     topiramate in increasing doses ranging from 50 to 400 mg. or diphenhydramine in doses ranging     from 6.25 to 50 mg. The drug doses will be increased gradually over 4 weeks to minimize     possible side effects. Increases will continue until the maximum tolerated dose is reached.     Patients will continue on the highest tolerated dose for two weeks and then be tapered off     gradually over 12 days. They will remain off drugs completely for a 2-day washout period and     then begin the next treatment. Those who took topiramate for the first part will take     diphenhydramine for the second part and vice versa.      A study nurse will call patients twice a week throughout the study to check for problems and     answer questions. A physician will see patients 6 weeks after the start of each treatment.     During the last visit, at the end of the study, patients will repeat the questionnaires they     filled out at the beginning of the study. Patients and their doctors will be informed of the     medications that were effective in each individual's care.   "
166907|NCT00011817|"     This study offers evaluation and treatment for patients with inherited (genetic) eye     diseases. The protocol is not designed to test new treatments; rather, patients will receive     current standard of care treatments. The purpose of the study is twofold: 1) to allow     National Eye (NEI) Institute physicians to increase their knowledge of various genetic eye     diseases, identify possible new avenues of research in this area, and maintain their clinical     skills; and 2) to establish a pool of patients who may be eligible for new studies as they     are developed. (Participants in this protocol will not be required to join a new study; the     decision will be voluntary.)      Children and adults with genetic eye diseases may be eligible for this study. Candidates will     be screened with a medical and family history, thorough eye examination and blood test. The     eye examination includes measurements of eye pressure and visual acuity (ability to see the     vision chart) and dilation of the pupils with eye drops to examine the lens and retina (back     part of the eye). Patients may also undergo additional diagnostic tests needed to determine     eligibility for other NEI studies, including routine laboratory testing, imaging,     questionnaires, a physical examination, and other standard and specialized tests and     procedures as needed. In addition, patients will have special photographs taken of the eye to     document the clarity or opacity of the eye lens. They will also undergo a procedure called     electroretinography to assess the eye's response to bright lights. For this procedure, the     eye is numbed with anesthetic drops and a contact lens is placed in the eye. The patient     looks inside a large, hollow sphere and sees flashes of light, first in darkness and then in     light. The contact lenses sense small electrical signals generated by the retina.      Patients who need medical care will be given appropriate standard medical treatment. Those     who are found eligible for a research study will be recommended for participation in that     study and taken off this one.      Participants will be followed at least 3 years. Follow-up visits are scheduled according to     the standard of care for the individual patient's eye problem. Patients in this protocol will     probably have 1 to 3 follow-up visits per year.   "
166908|NCT00011830|"     This study will examine 1) whether it is possible to collect enough stem cells (cells     produced by the bone marrow that mature into white and red blood cells and platelets) from     patients with aplastic anemia to use for future treatment, and 2) whether patients who have     been treated successfully and relapse will benefit from autologous stem cell transfusion     (transfusion of their own stem cells).      Patients 12 years of age or older with aplastic anemia who have been successfully treated     with immunosuppressive drugs and are now in remission may be eligible for this study.     Participants will undergo a complete history and physical examination, bone marrow biopsy     (removal of a small sample of bone marrow from the hip bone) and blood tests, plus procedures     to collect stem cells, as follows:        -  G-CSF (Filgrastim) administration - G-CSF will be given by injection under the skin          daily for up to 10 days. This drug causes stem cells to move from the marrow into the          blood where they can be collected more easily.        -  Apheresis - Stem cells will be collected through apheresis, usually starting the 5th to          6th day of Filgrastim injections. For this procedure, whole blood is collected through a          needle in an arm vein. The blood circulates through a cell separator machine where the          white cells and stem cells are removed. The red cells, platelets and plasma are returned          to the body through a second needle in the other arm. The procedure takes about 5 hours.          Up to five procedures, done on consecutive days, may be required to collect enough cells          for transplantation. If enough cells are collected, they will be purified (treated to          remove the white blood cells) using an experimental device. Removing the lymphocytes may          reduce the chance of relapse of aplastic anemia following the stem cell transplant. The          stem cells will be frozen for later use, if needed.        -  Follow-up - Participants are followed at NIH at 6-month intervals.   "
166909|NCT00011843|"     This study will try to learn more about the genetic cause and symptoms of microphthalmia     (small eyes) or anophthalmia (absence of one or both eyes).      Patients with microphthalmia or anophthalmia with mental retardation may be eligible for this     study. Patients' parents and siblings will also be included for genetic studies. Patients may     participate in both the clinical and laboratory parts of the study or just the laboratory     part, as described below:      Laboratory      The laboratory study consists of DNA analysis to determine the genetic cause of     microphthalmia/anophthalmia. The DNA sample is obtained using one of the following methods:        -  Blood draw - for young children, a numbing cream is applied to the skin before the          needlestick to decrease the pain        -  Skin biopsy - a small piece of skin (about 1/8-inch in diameter) is removed surgically          after the area has been numbed with an anesthetic        -  Cotton swab - a specimen is collected from inside the cheek using a cotton swab. This is          done only for patients who cannot provide a blood or skin sample.        -  Prenatal sample - If, in the case of newborns, specimens are left from prenatal testing,          these can be used instead of a blood sample.      Some patients may have a permanent cell line grown from the blood or skin sample for use in     future research tests.      Clinical      For the clinical study, participants undergo some or all of the following procedures at the     NIH Clinical Center:        -  Physical examination        -  Clinical photographs, X-rays, blood tests        -  Magnetic resonance imaging (MRI) scan of the brain - a diagnostic procedure that uses a          magnetic field and radio waves instead of X-rays to produce images of the brain   "
166910|NCT00011856|"     This study will investigate cerebral (brain) aneurysms and their possible inheritance     patterns in families. It will try to determine how often brain aneurysms occur in families in     which more than one member has had an aneurysm and to find the gene or genes that contribute     to their development.      People in families in which more than one family member had a cerebral aneurysm are eligible     for this 1-day study. They will undergo the following procedures:        -  Blood will be drawn (no more than 3 to 4 tablespoons) for research to identify genes          that contribute to the development of brain aneurysms.        -  A magnetic resonance angiograph (MRA) scan will be done to examine a specific brain area          where aneurysms typically occur. Magnetic resonance imaging uses a strong magnetic field          and radio waves to produce images of the brain and detect abnormalities.      If a more detailed picture of the brain is needed than can be obtained with MRA, a more     specific MRA scan will be done using a contrast dye to enhance the images.      Patients may be invited to participate in related NIH research studies.   "
166911|NCT00011895|"     The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus     efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).   "
166924|NCT00012090|"     RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep     growing. Goserelin may interfere with the growth factor and may stop the tumor from growing.     Bicalutamide may prevent androgens from stimulating the growth of cancer cells.      PURPOSE: Phase II trial to study the effectiveness of goserelin plus bicalutamide in treating     patients who have refractory or recurrent cancer of the ovary, fallopian tube, or peritoneum.   "
166925|NCT00012103|"     RATIONALE: Imaging procedures such as computed tomography may improve the ability to detect     lung cancer earlier.      PURPOSE: Screening and diagnostic study of computed tomography in women who are at risk for     lung cancer.   "
166926|NCT00012116|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who     have advanced solid tumors that have spread to the brain.   "
166927|NCT00012129|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of annamycin liposomal in treating     patients who have locally advanced or metastatic breast cancer that has not responded to     previous chemotherapy.   "
166912|NCT00011908|"     This study will examine the safety of a new genetically engineered antibody called hLL2     (epratuzumab) in patients with systemic lupus erythematosus (SLE). It will also evaluate     whether hLL2 can lessen overall disease activity in SLE or kidney damage in patients with     lupus nephritis.      Patients 18 years of age and older with mild to moderately active SLE may be eligible for     this study. Candidates will be screened with blood and urine tests, a chest X-ray,     electrocardiogram (EKG), tuberculin skin test, and screening tests for certain cancers.      All participants will receive weekly infusions of hLL2 for 4 weeks. The drug is given through     a catheter (small plastic tube) placed through a needle in an arm vein. Each infusion takes     about 2 hours, after which the patient is observed in the clinic for 1 to 2 hours before     being discharged from the clinic.      The first 3 patients in the study will receive the lowest of three different doses used in     the study. If this dose is well tolerated, the next 5 patients will receive a higher dose. If     the second dose is tolerated, the last 5 patients will be given the highest dose. If any     serious problems are encountered at a dose, patients in the next group will receive either     the same or lower dose before being advanced to the next level. Patients in the first group     will continue taking prednisone at their regular dose. All other patients will have their     prednisone tapered gradually, if their condition permits. Patients who have a disease flare     may have their prednisone increased for up to 2 weeks, followed by a gradual taper. If the     flare is severe or does not respond to the increased prednisone, the patient will be taken     off the study and treated to control the disease.      Patients will be evaluated at various intervals for up to 8 weeks after the last dose.     Several of the screening tests will be repeated throughout the study. No more than 500 ml of     blood-the equivalent of a single blood donation-will be collected during a 2-month period.     Participants may also be asked to undergo the following optional procedures before starting     treatment, 1 week after the last dose and 8 weeks after the last treatment dose:        -  Bone marrow aspiration - to collect cells from the bone marrow. The hip area is          anesthetized and a special needle is used to draw bone marrow from the hipbone.        -  Tonsil biopsy - The area to be biopsied is numbed with a local anesthetic and small          pieces of tissue will be removed with a special type of forceps. (The procedure may be          done under general anesthetic.)        -  Magnetic resonance imaging (MRI) of the abdomen - The patient lies on a table within a          metal cylinder (the MRI scanner) for about 30 to 40 minutes while images are obtained          with the use of a strong magnetic field and radio waves.   "
166913|NCT00011921|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving chemotherapy with peripheral stem cell transplant or bone     marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill     more tumor cells. It is not yet known whether high-dose chemotherapy plus peripheral stem     cell or bone marrow transplant is more effective than chemotherapy alone in treating small     cell lung cancer.      PURPOSE: This randomized phase III trial is studying how well chemotherapy followed by     peripheral stem cell or bone marrow transplant works compared to chemotherapy alone in     treating patients with limited-stage or extensive-stage small cell lung cancer.   "
166914|NCT00011934|"     RATIONALE: Biological therapy may increase the number of immune cells found in bone marrow     and may help a person's immune system recover from the side effects of the chemotherapy used     in treating chronic myeloid leukemia. Bone marrow transplantation may be able to replace     immune cells that were destroyed by chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation,     chemotherapy, and biological therapy in treating patients who have chronic myeloid leukemia.   "
166915|NCT00011960|"     RATIONALE: Drugs used in chemotherapy such as cisplatin and paclitaxel use different ways to     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Cisplatin and paclitaxel may make the tumor cells     more sensitive to radiation therapy and may kill any tumor cells remaining after surgery.      PURPOSE: Randomized phase II trial to study the effectiveness of cisplatin, paclitaxel, and     radiation therapy with or without fluorouracil in treating patients who have stage IB, stage     IIB, or stage IIIB stomach cancer that has been removed during surgery.   "
166916|NCT00011973|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who     have advanced kidney cancer.   "
166917|NCT00011986|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. It is not yet known which combination chemotherapy regimen is most effective     in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to     compare the effectiveness of various combination chemotherapy regimens in treating patients     who have stage III or stage IV ovarian cancer or primary peritoneal cancer.   "
166918|NCT00011999|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy following surgery may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in     treating patients who have undergone surgery for stage III or stage IV head and neck cancer.   "
166919|NCT00012012|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor     cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to     damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.     Drugs such as amifostine may protect normal cells from the side effects of radiation therapy.      PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation     therapy with or without amifostine in treating patients who have stage IIIB or stage IVA     cancer of the cervix.   "
166920|NCT00012025|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells.      PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who     have metastatic breast cancer that has not responded to previous hormone therapy.   "
166921|NCT00012038|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of irofulven in treating patients who     have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme.   "
166922|NCT00012051|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Peripheral stem cell     transplant may be able to replace immune cells that were destroyed by the chemotherapy.     Monoclonal antibodies, such as rituximab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. It is not yet known if giving more than one     drug (combination chemotherapy) plus peripheral stem cell transplant is more effective with     or without monoclonal antibody therapy in treating non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying how well chemotherapy plus peripheral     stem cell transplant with or without monoclonal antibody therapy works in treating patients     with relapsed non-Hodgkin's lymphoma.   "
166932|NCT00012194|"     Phase I trial to study the effectiveness of combining UCN-01 with cisplatin in treating     patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of     tumor cells by blocking the enzymes necessary for tumor cell growth and may help cisplatin     kill more cancer cells by making tumor cells more sensitive to the drug.   "
166933|NCT00012207|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Drugs used in chemotherapy use different ways to stop cancer cells     from dividing so they stop growing or die. Combining biological therapy with chemotherapy may     kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of biological therapy after chemotherapy in     treating patients who have relapsed or refractory non-Hodgkin's lymphoma.   "
166934|NCT00012220|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if gemcitabine is more effective when given     alone or in combination with another chemotherapy drug in treating cancer of the pancreas.      PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine given alone or     in combination with other chemotherapy drugs in treating patients who have metastatic cancer     of the pancreas.   "
166935|NCT00012246|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of two different vaccines in     treating patients who have cancer of the gastrointestinal tract.   "
166936|NCT00012259|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of troxacitabine in treating patients who     have blast phase chronic myelogenous leukemia.   "
166937|NCT00012298|"     Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibody     therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who     have relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal antibodies can     locate cancer cells and deliver cancer-killing substances to them without harming normal     cells. Biological therapies such as filgrastim and interleukin-11 use different ways to     stimulate the immune system and stop cancer cells from growing.   "
166938|NCT00012311|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give     higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if     chemotherapy followed by peripheral stem cell transplantation is more effective than     chemotherapy alone in treating metastatic breast cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy     plus peripheral stem cell transplantation with that of chemotherapy alone in treating women     who have stage IV breast cancer.   "
166939|NCT00012324|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which chemotherapy regimen is more effective     for liver cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different     chemotherapy regimens in treating patients who have recurrent or unresectable liver cancer.   "
166940|NCT00012337|"     RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep     growing. Drugs such as ZD 1839 may interfere with the growth factors and cause tumor cells to     die.      PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have     metastatic kidney cancer.   "
166941|NCT00012350|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have     relapsed or refractory multiple myeloma.   "
166942|NCT00012363|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have metastatic or recurrent cancer of the esophagus.   "
166943|NCT00012376|"     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Colony-stimulating factors such as sargramostim may increase the number of     immune cells found in bone marrow or peripheral blood and may help a person's immune system     recover from the side effects of chemotherapy. Phase I trial to study the effectiveness of     bryostatin 1 combined with sargramostim in treating patients who have refractory myeloid     cancer   "
166944|NCT00012389|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if irinotecan is more effective with or without     oxaliplatin in treating metastatic colorectal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or     without oxaliplatin in treating patients who have metastatic colorectal cancer.   "
166945|NCT00012428|"     This project is designed to investigate the association between prenatal exposure to     environmental contaminants on cognitive development of school-age children   "
166955|NCT00012584|"     The purpose of this NIMH-sponsored pilot study is to collect information on the efficacy and     safety of drug treatments for children and adolescents who suffer from both ADHD and anxiety     disorders. Specifically, the study will examine the benefits of the stimulant medication both     alone and in combination with fluvoxamine, a selective serotonin reuptake inhibitor (SSRI)     that has antianxiety effects. Young people aged 6 to 17 diagnosed with these co-occurring     disorders may be eligible to participate.   "
166956|NCT00012597|"     A Web-based telemedicine system for monitoring the status of patients with pressure ulcers     has been developed. It consists of three major data collection components: (1) digital     photograph of ulcer; (2) quantitative measurements of wound status (i.e., ulcer area and     volume, skin elasticity); and (3) other wound and patient data collected by a nurse. Data are     collected via laptop computer and transmitted to a central database, where a computer program     transforms the data into the necessary reporting format. The output is posted onto a World     Wide Web page for access by the consulting physician. The system incorporates all data     requirements for assessment recommended by AHCPR's Clinical Practice Guideline, Treatment of     Pressure Ulcers.   "
166946|NCT00012441|"     Hemodialysis remains associated with a high mortality (approximately 22% per year) and many     complications despite improvements over the last twenty years. Several nephrologists have     suggested that increasing the frequency and amount of dialysis will result in improved     outcomes. In fact, various forms of daily dialysis have been performed in over 300 patients     in the last 30 years with improvements in blood pressure, quality-of-life, bone disease, and     other complications of renal failure. Whether this form of treatment can be expanded to the     220,000 Americans on hemodialysis is unknown. The primary outcome of this study is to     determine the effectiveness of nocturnal dialysis in hemodialysis patients in St. Louis. If     the pilot study is effective, then participation in a larger, multicenter trial is expected.     The endpoints measured are use of antihypertensive medications, improvement in secondary     hyperparathyroidism and use of phosphorus binders, quality-of-life measured by SF-36 surveys,     and improvement in physical function as measured by maximal oxygen uptake.   "
166947|NCT00012454|"     This study will test the safety and effectiveness of a protein called E-selectin, given as a     nasal spray, in preventing the formation of blood clots that can cause stroke. In animal     studies, animals that received E-selectin in the nose on a regular schedule had almost no     strokes compared with those that did not receive it.      Patients over age 45 who have had a stroke or transient ischemic attack (TIA) within 1 to 4     months of this study may be eligible to participate. Candidates will be screened with a     review of their past medical records and neurologic and medical evaluations that may include     magnetic resonance imaging (MRI) of the brain, ultrasound or magnetic resonance angiography     (a type of MRI) of the carotid arteries (arteries in the neck that supply blood to the     brain), echocardiography (ultrasound test of the heart), electrocardiography (EKG) and blood     tests.      Participants will have a blood and urine test and will be assigned to one of four treatment     groups. Patients in each group will spray a small amount of fluid into their nose according     to the following schedule: 5 doses once every other day for 10-days, followed in 3 weeks by     another 5 doses every other day for 10-days, followed in 3 weeks by a final series of 5 doses     every other day for 10 days. The spray for patients in each group contains the following:        -  Group 1 - fluid with low dose of E-selectin        -  Group 2 - fluid with medium dose of E-selectin        -  Group 3 - fluid with high dose of E-selectin        -  Group 4 - fluid with no E-selectin      Patients will be seen for follow-up visits at 1 month and 3 months after starting E-selectin     therapy. The visits will include a neurologic examination and blood and urine tests. Patients     will be contacted by phone, fax or e-mail in between the 1- and 3-month visits.   "
166948|NCT00012467|"     The purpose of this study is to examine the antifungal activity of recombinant     interferon-gamma 1b (rIFN-gamma 1b) given with standard antifungal therapy.   "
166949|NCT00012480|"     Our data indicate that environmental exposure to the heavy metal lead are more widespread     than currently appreciated and that such exposures are associated with the production of     human male subfertility. Lead's effects are observed in male partners of infertile couples     attending an IVF clinical, in men acting as semen donors in an artificial insemination     program and in men representative of the general public. Our goal is to identify the     mechanism(s) underlying lead's anti-fertility action.   "
166950|NCT00012493|"     This project is part of a program project directed toward assessing cardiac effects of     particulate and other ambient air pollutants. In this project patient who have recently     suffered a cardiac event are being monitored with cardiac monitors for 24 hours up to 4 times     during the year following their cardiac event. Similarly a second group of patients with     moderate to severe heart failure will undergo similar cardiac monitoring for 24 hours, twice     a week separated by 3 months. In both sets of patients home indoor pollution measures will be     continuously made and used to correlate with measures of heart rate variability.   "
166951|NCT00012506|"     This study will investigate the safety and effectiveness of the drug Enbrel (TNFR:Fc) to     treat uveitis (eye inflammation) in patients with juvenile rheumatoid arthritis.   "
166952|NCT00012519|"     Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has     not been approved for use in children and the doses for the combination of the two drugs has     not been studied in children. The purpose of this study is to find a combination of RTV and     IDV that is safe, well tolerated, and produces drug levels in the blood of children that are     comparable to effective drug levels in the blood of adults. The effectiveness of the drug     combination in decreasing the amount of virus in the body will also be studied. The children     enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs.   "
166953|NCT00012545|"     This study will determine the best ways to collect, process and store umbilical cord blood     from babies with sickle cell disease, sickle cell trait and unaffected babies. Sickle cell     disease is an abnormality of the hemoglobin in red blood cells that causes the cells to     change shape and clump together, preventing their normal flow in the bloodstream. This     impairs blood flow to various organs, and the resulting oxygen deprivation causes organ     damage.      Cord blood is rich in stem cells (cells produced in the bone marrow that mature to different     types of blood cells), which may prove useful in new sickle cell therapies. However, cord     blood from babies with sickle cell trait, sickle cell disease and normal babies may act     differently under laboratory conditions, so it is important to learn how best to work with     blood from all three groups of babies for future use in possible treatments.      Pregnant women between 18 and 45 years of age who are at risk of having an infant with sickle     cell disease and normal volunteers who are pregnant and not at risk for this disease may be     eligible for this study. Potential participants will be counseled about donating her infant s     blood in order to make an informed choice.      All women who participate in the study will provide a medical history and have blood     collected from the umbilical cord and placenta (afterbirth) after the baby s delivery. The     blood will be tested for various infectious diseases, processed, frozen and stored for     research purposes. In addition, blood from women with babies at risk for sickle cell disease     will be tested for the presence of the sickle cell gene, tissue typed, and used for research     as follows:        -  Sickle cell disease If cord blood tests show the baby has sickle cell disease, the blood          will be frozen for an indefinite period of time for possible use in future treatment of          the child. This treatment could include stem cell transplantation or gene therapy,          treatments are not currently considered routine for sickle cell disease.        -  Sickle cell trait or normal hemoglobin If cord blood tests show the baby has sickle cell          trait or is unaffected, the blood will be processed and stored for up to 3 years, during          which time it may possibly be used to treat a currently living or future sibling with          sickle cell disease. After 3 years, the participant may agree to either have the blood          discarded, given to research or moved to another facility for continued storage at the          participant s expense, if there is a storage fee. Alternatively, if there is no          anticipated future need for the collected blood, or if it does not meet standards needed          for future treatment, it will be used in NIH-approved research studies.      Participants and their family doctor or the baby s pediatrician will be contacted twice a     year for information about changes in the baby s health. Participants may also be asked     permission to perform new tests developed by researchers.   "
166954|NCT00012558|"     A long-term study of current treatments for bipolar disorder, including medications and     psychosocial therapies.   "
167073|NCT00014144|"     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor     cells and slow the growth of cancer of the urinary tract.      PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have     advanced cancer of the urinary tract.   "
166957|NCT00012610|"     Telepsychiatry is a novel means of providing expert psychiatric treatment to patients who     live far from a source of care. If it can be demonstrated that treatment via telepsychiatry     is as effective as in-person treatment, then many individuals with psychiatric illness will     have easy access to psychiatric care, even if they live in geographically remote areas.   "
166958|NCT00012623|"     CBOCs represent one of VA's main managed care strategies for shifting the focus of care from     the inpatient to the outpatient setting and for improving the health of our nation's     veterans. Hypothesis-driven research is critically needed to test the basic assumptions     motivating the expansion of CBOCs throughout the VA health care system.   "
166959|NCT00012636|"     Hypertension is a major risk factor for heart disease and stroke. Evidence-based guidelines     support the use of specific drugs for patients with specific comorbidities to maximize the     decrease in cardiovascular risk; yet, many physicians do not follow these guidelines in     choosing drug therapy.   "
166960|NCT00012649|"     The purpose of this study is to improve the quality of VA diabetes care using an automated     telephone disease management (ATDM) system that administers patient assessments and targeted     self-care education between clinic visits.   "
166961|NCT00012662|"     Social, medical and economic burdens of diabetes care result from microvascular,     macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce     the incidence of these complications by as much as 50 percent. Studies have demonstrated     improved glycemic control with nurse case-management or educational care models. However,     none have controlled for their independent contributions, intervened with advanced practice     nurses (APN), or targeted highest risk individuals.   "
166962|NCT00012675|"     Many patients with diabetes are under sub-optimal glycemic control. Central to the     clinician's task in improving glycemic control is the management of hypoglycemic medication     therapy, including the use of drugs such as insulin and sulfonylureas. Clinical trials have     demonstrated that more intensive hypoglycemic medication therapy results in improved glycemic     control. Yet quality measures for this critical process of care have not been developed and     we know little about how physicians actually manage hypoglycemic medications.   "
166963|NCT00012688|"     Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care     include the prevention and/or delay of complications via adequate glycemic control.     Improvements in periodontal status may also improve diabetes control.   "
166964|NCT00012701|"     The VA is the largest single provider of HIV care in the United States. The late 1990's have     seen a revolution in the quality standards for this disease with the onset of Highly Active     Antiretroviral Therapy (HAART) and other developments.   "
166965|NCT00012714|"     Prior rehabilitation outcome studies had many weaknesses. They had: a) evaluated     rehabilitation effects only in isolated subgroups, b) focused on functional ability rather     than on quality of life, c) not used randomized control groups, and d) had inadequate sample     sizes. Differences in methodological approaches have resulted in inconsistent findings. The     lack of long-term benefits suggests that services may need to be continued at home or in     subacute care settings to optimize their effectiveness. Unfortunately, prior research did not     include behavioral outcomes. The potential benefits of rehabilitative care could thus not be     evaluated by these studies in more meaningful detail, and they did not accurately reflect the     psychosocial objectives of rehabilitation.   "
166966|NCT00012727|"     This project�s goal is to improve the quality of care and reduce treatment costs for veterans     with substance abuse and psychiatric problems.   "
166967|NCT00012740|"     Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many     innovative geriatric care programs exist within VHA, we still lack a systematic process for     identifying at-risk elders from the larger VA population who are likely to benefit from     specialized geriatric services.   "
166968|NCT00012753|"     Regular outpatient follow-up is important for all diabetes patients, with some needing     frequent attention because their health is unstable, their treatment regimen is complex, or     their social supports are inadequate. However, many patients live with access barriers that     limit their use of outpatient services, fail to attend outpatient appointments, and     experience worse outcomes than trials of aggressive management suggest is possible. Although     labor-intensive, telephone care programs are one potential strategy for bringing diabetes     management services into patients� homes and improving their glycemic control. Automated     telephone disease management (ATDM) systems can augment telephone care by providing frequent     monitoring and health education to large patient panels while focusing clinicians� attention     on individuals who need it most. Although this technology has shown some promise, it has not     been rigorously evaluated, particularly in VA.   "
166969|NCT00012766|"     Most depression treatment takes place in primary care, where the condition continues to be     under-detected and under-treated. A collaborative care model derived from chronic illness     management theory has been successful in improving care in other managed care settings.   "
166970|NCT00012779|"     This study was designed to assess the effectiveness of a Health Education Program (HEP) for     improving the well-being and reducing the health care use and cost of care of frail older     outpatient veterans, and for improving the well-being of their spouse caregivers. HEP is a     multi-component group program delivered in 8 weekly, 2-hour sessions, and 10 monthly 2-hour     follow-up sessions, it includes emotion-focused and problem focused coping strategies,     education and support.   "
167074|NCT00014170|"     Biological therapies such as gefitinib may interfere with the growth of the tumor cells and     slow the growth of glioblastoma multiforme. Phase II trial to study the effectiveness of     gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.   "
167009|NCT00013286|"     This project will identify risk factors for diabetic foot ulcer by studying the relationship     between endothelial dysfunction and foot ulcer risk. A fundamental defect in type 1 and 2     diabetic subjects is impaired vasodilatory reserve which is reflected in the dysfunction of     endothelium-dependent vasodilation. Findings thus far point to an important role of the     microvasculature in the development of diabetic foot ulcer and amputation.      In this study a a well-characterized cohort of 750 diabetic veterans without foot ulcer will     be followed over 3-years.   "
167628|NCT00030095|"     RATIONALE: 2-Methoxyestradiol may stop the growth of cancer by stopping blood flow to the     tumor.      PURPOSE: Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients     who have advanced solid tumors.   "
166971|NCT00012792|"     Chronic obstructive pulmonary disease (COPD) is one of the most common chronic illnesses in     the adult population and accounts for approximately 25,000 discharges from VA hospitals in a     calendar year. In addition to the burden put on the health care system, COPD is a disabling     condition that adversely affects functional status and quality of life (QOL). Several reports     have suggested that exercise training programs can reduce the frequency of hospitalization     for COPD; however, these reports have important methodological limitations and such programs     have not been widely implemented in the VA health care system. Although the underlying lung     pathology of COPD may be unalterable, physical reconditioning has been clearly demonstrated     to improve cardiorespiratory status in COPD patients. These physiologic changes have the     potential to substantially improve QOL and reduce functional disability. Moreover, improved     cardiorespiratory reserve may decrease the utilization of health care resources during mild     to moderate exacerbation of COPD.   "
166972|NCT00012805|"     Chronic obstructive pulmonary disease (COPD) is one of the most common chronic illnesses     among veterans in the adult population, and accounts for substantial morbidity and mortality     in this population. Interventions that enhance symptom self-monitoring and increase     understanding of COPD therapy may lead to earlier detection of clinical deterioration     permitting more timely intervention by health care providers. However, such interventions are     labor-intensive and expensive, and typically require patients to go to a medical facility on     a regular basis. A novel means of providing such interventions is a Telephone-Linked Computer     (TLC) system, a computer-based telecommunications system that can monitor, educate, and     counsel patients through regular automated conversations in patients� homes. In previous     studies, we have demonstrated the applicability of TLC technology in the clinical monitoring     of adults with chronic disease conditions such as hypertension and hypercholesterolemia.   "
166973|NCT00012818|"     Despite the development of significant pharmaceutical treatments, morbidity and mortality of     chronic heart failure (CHF) patients remain high, patients� quality of life is poor, and     their health care utilization is heavy. It is therefore important to find a cost effective     non-pharmaceutical treatment to help CHF patients manage the disease. The relaxation response     has been found to be effective in managing CHF-related conditions. With its favorable     physiological changes, the relaxation response is likely to benefit CHF patients.   "
166974|NCT00012831|"     This study evaluates the effectiveness of a nurse-managed interdisciplinary (nursing and     occupational therapy) clinic serving community dwelling dementia patients and their spouse     caregivers. It is grounded in a nursing self-care model that guides nurses to identify     interventions that fit with the capabilities of individual patients and compensate for their     specific deficits. The occupational therapy assessment uses the Allen Cognitive Levels that     identify the abilities and deficits of a particular functional level so that the strategies     and approaches taught to caregivers can be tailored to the specific needs of the patient.   "
166975|NCT00012844|"     This study is one of several initiated by the investigators to reduce musculoskeletal     injuries in patient care providers. Nurses have one of the highest incidences of work related     back injuries of any profession. Over the past 20 years, efforts to reduce work-related     injuries in nursing have been largely unsuccessful.   "
166976|NCT00012857|"     Dementia illness often co-exists with painful medical conditions associated with aging (e.g.,     degenerative joint disease, osteoarthritis, skin ulcers, back pain, headaches, cancer, or     angina). While the standard practice is pain assessment for all patients, the elderly with     dementia have special needs for assessment, management, and evaluation. When they are unable     to verbalize pain, objective measurement of their discomfort are possible manifestations of     pain. No research relates systemic pain treatment with reduction of negative problematic     behaviors in patient dementia.   "
166977|NCT00012870|"     Nurses play an important role in helping patients to manage symptoms, adhere to treatment,     and change behavior. There has been a lack of research regarding nonpharmacologic     interventions with patients with heart failure and other chronic conditions.   "
166978|NCT00012883|"     Heart failure is a major public health burden in the United States characterized by increased     morbidity and mortality, and reduce exercise capacity with distressing symptoms of dyspnea     and fatigue. Evaluating the effects of complementary intervention (such as exercise training)     on functional status and QOL are clinically important and relevant to HF patients.      In the last decade, hospital-based and a home bicycle exercise programs for HF have been     shown to improve peak oxygen consumption (VO2) and symptom scores, and restore autonomic     balance. These programs may be costly for patients to perform. Improved peak VO2 may not     necessarily translate into improved functional status and quality of life. To date, the     effects of a home walking exercise program alone on functional status, QOL and autonomic tone     has not been evaluated.   "
166979|NCT00012896|"     Cancer pain is a pervasive problem for the person with cancer. Despite advances in knowledge,     effective cancer management is infrequently achieved. While this problem is multi-factorial,     the patient may have attitudinal barriers to effective pain management that can be     ameliorated with novel interventions.   "
166980|NCT00012909|"     The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT)     is complex because patients must balance the short and long-term risks and benefits.     Information from new and important clinical trials must also be considered. The purpose of     this research is to develop and evaluate the efficacy of a HT CD-ROM decision-aid in     improving the decision making process for women considering the use of estrogen HT.   "
166981|NCT00012922|"     Of 17 performance measures of hospital quality regularly reported for the Veterans     Administration (VA) health care system, rates of colorectal cancer screening are the lowest.   "
166982|NCT00012935|"     Newly diagnosed localized prostate cancer patients face difficult decisions about treatment     and management; including radiation therapy, radical prostatectomy, brachytherapy, and     observation. Previous studies have cited patient preference and physician recommendation for     treatment as major roles in treatment decisions.   "
167075|NCT00014183|"     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor     cells and slow the growth of kidney cancer.      PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have     recurrent or stage IV kidney cancer.   "
187135|NCT00294970|"     Cognitive profile of patients who suffer both from PTSD and OCD, as compared to those who     suffer from PTSD or OCD without other comorbidity.   "
166983|NCT00012948|"     Smoking cessation interventions including behavioral and pharmacological components have been     demonstrated to be both effective and cost-effective. Although there is a high prevalence of     smoking and smoking-related disorders among veterans who use VA medical centers for health     care, rates of identification of tobacco use and provision of brief and/or intensive smoking     cessation services are suboptimal. Telephone outreach (TO) may serve to increase access to     counseling and medications to assist smoking cessation. From the standpoint of health     systems, TO provides the opportunity for centralized oversight and quality assurance, economy     of scale, and dissemination strategies that are practical to implement. At the provider     level, TO addresses barriers to delivery of services such as limited time and skills. From     the standpoint of the smoker, attractions of TO include accessibility, convenience, and     privacy.   "
166984|NCT00012961|"     Schizophrenia exacts a high toll on the lives of patients and their families and constitutes     a major health care cost. VISN 5 has placed special emphasis on improving care for veterans     with severe mental disorders, an effort recently recognized by the VA as a Program of     Excellence in the Care of Seriously Mentally Ill Veterans.   "
166985|NCT00012974|"     The purpose of this study is to examine the efficacy of telephone-administered     cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by     community-based outpatient clinics (CBOCs) in the Veteran�s Integrated Service Network (VISN)     21, which serves rural areas in Northern California   "
166986|NCT00012987|"     Smoking is a serious and common health risk among veterans. Given the press of national     initiatives and local incentives to improve smoking cessation care in response to VA     performance measures, this study tests a widely applicable approach to clinical practice     guidelines implementation, namely evidence-based quality improvement, which is directly     relevant to the translation of efficacious treatments into enhancements in VA health care     policy and practice. Evidence-Based Quality Improvement (EBQI) focuses on improved provider     adherence to smoking cessation guidelines and a decrease in patient smoking rates in a manner     designed to produce short- and long-term health improvements and cost benefits at the     organizational level.   "
166987|NCT00013000|"     Schizophrenia, a chronic psychiatric disorder, is the second most frequent VA discharge     diagnosis. Medication management practices for schizophrenia often are not     guideline-concordant and place patients at risk for adverse outcomes. This project tests a     new strategy to standard implementation for VHA Schizophrenia Guidelines.   "
166988|NCT00013013|"     Among veterans, smoking is the single most important risk factor for preventable mortality     and morbidity, and studies suggest a higher prevalence of smoking among veterans than the     general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking     Cessation, yet most hospitals have poorly developed smoking cessation programs.   "
166989|NCT00013026|"     Congestive heart failure is a serious health problem in the United States and is associated     with excessive morbidity and mortality. Several classes of medications have been shown to     improve mortality in patients with CHF. Despite this these medications are widely under     prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on     the management of CHF have been published. Implementation of guidelines is challenging and     most strategies have focused on changing physician behavior. Patient-based interventions have     been shown to be effective in implementing guidelines on CHF but they have been very labor     intensive. A computer based intervention to implement CHF guidelines, if effective, would be     beneficial.   "
166990|NCT00013039|"     Physician compliance with practice guidelines is imperfect. Computer-generated reminders from     electronic medical record systems have been shown to increase compliance with guidelines, but     they often require symptom and history data, which limits computer facilitation. Heart     failure is a serious condition for which compliance with established guidelines is     suboptimal. Physicians� compliance with heart failure guidelines may improve if such     reminders use symptom and history data.   "
166991|NCT00013052|"     Control of the blood sugar prevents complications and results in extra years of life in     patients with diabetes. Practice Guidelines delineating specific ways physicians manage     diabetes have been outlined. Missing are guidelines for health care providers to encourage     patients to take responsibility for their diabetes. Traditional patient education models have     been ineffective in managing diabetic persons because they have relied upon information given     alone and are disease centered rather than patient centered. This study will explore the role     of self-efficacy in helping veterans move toward healthy behaviors.   "
166992|NCT00013065|"     It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To     benefit from recent improvements in anti-HIV therapy, patients need to take their medications     consistently.   "
166993|NCT00013078|"     Falls are the leading cause of nonfatal injuries in the United States and the second leading     cause of all unintentional injury deaths. Each year fractures of the hip account for about     200,000 hospitalizations among the elderly and falls are contributing factors in 40 percent     of admissions to nursing homes. About 30 percent of community-dwelling elderly fall each     year, with about 10 percent seeking emergency medical help for a fall injury. Data from     CDC-funded study to assess falls among the elderly (SAFE) suggest that as many as 41 percent     of elderly patients fall at home in the year following discharge from hospitalization due in     part to deconditioning associated with inactivity.   "
166994|NCT00013091|"     Post-traumatic stress disorder is a mental health problem of enormous proportion within the     VA system for both male and female veterans. The 40 percent of veterans with PTSD and     concurrent clinically significant depression are particularly difficult to treat. Effective     and efficient treatment of veterans with this combination of disorders would be of benefit to     a significant number of veterans.   "
166995|NCT00013104|"     The purpose of this study is to design and evaluate targeted implementation strategies to     fully integrate the VHA clinical practice guidelines for ischemic heart disease into VHA     clinical practice. Effectively implementing the guideline will enhance the quality,     appropriateness, timeliness, and cost effectiveness of care delivered to veterans with     ischemic heart disease.   "
167080|NCT00020891|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Multiple CT scans     may improve the accuracy of radiation therapy for prostate cancer.      PURPOSE: Phase I trial to study the effectiveness of multiple CT scans in guiding the     treatment of patients who have prostate cancer and are undergoing radiation therapy.   "
166996|NCT00013117|"     The goal of this research was to determine if providing specialist input to primary care     providers (PCPs) by means of informal consultation could improve the process and outcomes of     care for diabetes. Several studies support the role for specialists and their specific     knowledge and expertise in a variety of disorders including diabetes. A variety of methods     have been designed to optimize the use of specialty expertise including practice guidelines     and disease management approaches as well as the consultation/referral process. The     referral-consultation process is an important mechanism for obtaining clinically useful     information. At one end of the spectrum of this process, informal consultation involves     discussion about a patient with a colleague without the consultant seeing the patient; at the     other end of the spectrum, care of the patient is transferred to another physician and the     process is formalized. Because much specialist expertise resides in the specialists     themselves, the expansion of primary care sites to include community-based outpatient clinics     has implications for access to the specialists located elsewhere. This study was designed to     evaluate a computer-assisted voice mail system which is relatively inexpensive and more     convenient than video-telemedicine systems, making it more practical and more easily     exportable. Diabetes care delivery was chosen as the model in which to assess informal     consultation based on its frequency among veterans, management challenges, and the emphasis     on improvement in diabetes care in VA. A secondary goal of the project was to better     characterize the consultation process.   "
166997|NCT00013130|"     Health care organizations, including the VA, are investing substantial effort to improve     quality of care. As part of this process, greater emphasis is being placed on measurement of     outcomes, and in particular, functional outcomes and satisfaction as reported by patients.   "
166998|NCT00013143|"     Adverse drug events (ADE) present a unique focus for error reduction. Computerized provider     order entry, with embedded clinical decision support, has great promise in reducing     medication errors but preventable adverse drug events may still occur despite such systems.   "
166999|NCT00013156|"     Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve     quality of life in patients with COPD, but to date no controlled studies have evaluated the     impact of LVRS.   "
167000|NCT00013169|"     A variety of models of psychiatric hospital alternative care have been developed over the     past several decades. San Diego�s Short-Term Acute Residential Treatment (START) model is one     of the best established of these alternatives, comprising a network of 6 facilities with a     total of 77 beds. Although veterans have been among those served at START programs for many     years, no previous study of START or any other model has focused specifically on veterans.   "
167001|NCT00013182|"     Sleep-activity rhythm disturbance is a prevalent, disabling symptom in cognitively-impaired     (CI) elders. Their nocturnal sleep is light and inefficient with frequent awakenings.     Multiple short daytime napping episodes interfere with daytime activity and functioning.     Daytime disruptive behaviors, such as pacing, hitting, and cursing are related significantly     to sleep-activity rhythm disturbance. Medical treatment for sleep and behavior disturbances     with benzodiazepines or antipsychotic medications has proven minimally effective and has     serious side effects such as impairments in cognition, memory, coordination, and balance,     tolerance and severe rebound insomnia, and tardive dyskinesia.   "
167002|NCT00013195|"     Many elderly primary care patients are at high risk for health complications and functional     impairment due to low levels of physical activity. Previous trials of counseling of elderly     patients in primary care clinics have not demonstrated lasting physical activity change and     have not evaluated fitness changes associated with any increased activity.   "
167003|NCT00013208|"     Despite a growing array of therapeutic options and efficacious treatment strategies to     prevent or delay some of the most severe complications of type 2 diabetes, there continue to     be many individuals with outcomes that are far from optimal. Interventions to improve     diabetes care by educating providers and patients have been disappointing. In the past     several years, case management has been widely advocated as a cost-effective approach to     coordinate diabetes care and improve outcomes, although there is little rigorous evidence     demonstrating the benefits of this type of intervention.   "
167004|NCT00013221|"     Chronic heart failure (HF) is a syndrome of impaired ventricular function resulting in     clinical symptoms of fatigue, dyspnea, and decreased exercise capacity. These symptoms lead     to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning     and deterioration of muscle function. Until recently, the prescription for individuals with     HF was rest and minimization of physical exertion.   "
167005|NCT00013234|"     We have previously shown (IIR 95-045) that teledermatology, using store and forward     technology, can result in reliable and accurate diagnostic outcomes when compared to     clinic-based dermatology consultations. This investigation builds on that fundamental     diagnostic information by assessing the health services implications of a teledermatology     consult system.   "
167006|NCT00013247|"     Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most     authorities recommend that providers inform and involve patients in CaP screening decisions.   "
167007|NCT00013260|"     Managed care systems rely on primary care providers as gatekeepers to make sensible decisions     regarding the use of expensive health care resources. While this model has some intuitive     appeal in terms of its potential for decreasing health care costs, it may not be applicable     in VA medical centers, where patients are often medically complex and socioeconomically     vulnerable. Thus, other strategies to integrate generalist and specialist care are required.   "
167008|NCT00013273|"     The purpose of this research is to evaluate the efficacy of a structured program of physical     therapy in ameliorating the adverse consequences of Chronic Venous Insufficiency (CVI). The     study will also investigate the interrelationship among measure of chronic venous diseases:     lower limb muscle strength, mobility, and other symptoms of CVI important to the quality of     life. Sixty patients will be randomized to a 6 months physical therapy program or to a     control group.   "
167076|NCT00014196|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation     therapy in treating patients who have stage IIIB non-small cell lung cancer.   "
167010|NCT00013299|"     This is a randomized clinical trial to: (1) Determine the extent to which custom made study     shoes will reduce the incidence of reulceration in diabetic individuals with prior history of     foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.   "
167011|NCT00013312|"     This study will compare individuals with acute SCI to control patients in order to: 1.     Determine if there are changes in colonic tone and sensation after SCI by comparing the     fasting responses to the postprandial responses; 2. Determine if there are changes in colonic     phasic motility after SCI by comparing the fasting responses to the postprandial responses;     3. Determine if colonic motor and sensory function after SCI change over time by repeating     these studies six month later in SCI and control patients.   "
167012|NCT00013325|"     The purpose of this three-year study is to determine the prevalence and incidence of the     different types of cardiac disease and ECG abnormalities in SCI patients. Study goals are:     (i) delineation of the specific types of heart disease that occur in the SCI population as     manifested both pre-clinically and clinically and (ii) demonstration of their association     with ECG findings. This will enable validation of scores and algorithms using the inexpensive     and widely available ECG for the prevention of heart disease as well as it's early treatment     and rehabilitation in SCI patients.      The findings will be helpful in demonstrating what cardiological tests are appropriate for     the mandated annual evaluation of SCI patients.   "
167013|NCT00013338|"     This is a randomized, controlled trial to compare supported treadmill ambulation training     (STAT) to conventional gait training for improving gait speed, gait endurance, gait     efficiency and muscle function in SCI subjects injured more than six months prior to start of     training. Each subject will receive twelve weeks of either CGT or STAT, given as 20 minutes     of training within a one-hour period per day, five days per week. These subjects will be     studied baseline, 4,8 and 12 weeks of training, and three months after the end of training     with a battery of tests designed to evaluate the subjects' gait and muscle function.   "
167014|NCT00013351|"     The relationship between Useful Field of Vision (UFOV) and falls taken by the elderly will be     investigated. UFOV is a test which measures visual attention. The test has been used in     correlating the visual attention in the elderly with their driving safety record. The test is     administered using a computer and consists of three parts: a) subject views figures which     appear in the center of the computer screen and identified them as quickly as possible; b)the     subject has to identify figures in the center of the screen while at the same time point to     another symbol which will appear in one of eight places on the outer portion of the screen;     c) the third section is similar to the second except while the subject is identifying and     pointing there is a background noise.   "
167015|NCT00013364|"     The effects of talker variability will be investigated with four groups of listeners (young     normal-hearing; old normal-hearing; young hearing-impaired; old hearing-impaired).     Experimental conditions will include between-talker differences, speaking rate, lexical     difficult and semantic/linguistic context. A preliminary experiment will evaluate the     relative merit of adaptive vs fixed-level methods of stimulus presentation.   "
167016|NCT00013377|"     There are two diseases in particular that may have serious consequences for driving and     mobility due to their potentially severe impact on visual function: glaucoma and diabetic     neuropathy. In this project we will develop predictive models of driving for these patients     and will train them to use low-vision aids to improve driving mobility. We will determine how     best to train patients with hemianopic field loss due to cerebral vascular accidents and     identify predictors of long-term success in the use of low-vision aids.   "
167017|NCT00013390|"     The investigators propose to evaluate two different approaches to the alleviation of tinnitus     symptoms by comparing changes from baseline performance on the Tinnitus Severity Index. They     propose to provide an unbiased evaluation of competing methodologies. The design is one in     which pairs of prospective subjects are randomly assigned to one of two treatment groups.     Changes in group performance will be compared for selected measures.   "
167018|NCT00013403|"     The project has four primary objectives: 1) Determine if blind rehabilitation improves the     quality of life of legally blind veterans; 2) Determine the relationship between quality of     life and visual function; 3) Determine if factors, such as cognitive status, level of     depression, age and the presence of additional medical conditions besides vision loss,     intervention of blind rehabilitation extends beyond the visually impaired individual and     improve the quality of life of their primary caregiver (e.g. spouse, partner, family member     or friend.)   "
167019|NCT00013416|"     The long-term goal of this research program is to develop methods to predict both the benefit     and the satisfaction that hearing-impaired patients will derive from auditory amplification     in daily life. This proposal has three primary objectives: (1) To determine the influence of     extra-audiological variables, such as personality attributes and expectations, on the     subjective outcomes of hearing aid fittings, (2) To establish a scientific basis for     selection, administration, and interpretation of self-report measures of hearing aid fitting     outcome, (3) To resolve the long-standing debate about the efficacy of using clinically     measured loudness perception data in hearing aid prescriptions.   "
167020|NCT00013429|"     The project objective is to validate the types of eye trackers that may most effectively be     employed in the rehabilitation evaluation and training of people with central scotomas. The     eye trackers will include the three basic types of eye trackers, namely, 1)electrophysical,     2) front surface trackers, and 3) retinal trackers.   "
167077|NCT00014209|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have Hodgkin's disease or non-Hodgkin's lymphoma that has not responded to     previous treatment.   "
167082|NCT00020917|"     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of combining cetuximab with combination     chemotherapy in treating patients who have stage IV colorectal cancer.   "
187136|NCT00294983|"     Estimating the prevalence of OCD symptoms among patients with burns   "
167021|NCT00013442|"     Over one million persons in the United States are aphasic subsequent to a stroke. Most of the     individuals improve through spontaneous recovery and treatment. However, there are no precise     methods for predicting which patients will improve and, for those who do, how much     improvement will occur. There is a need to improve prognostic precision in aphasia. The     purpose of this investigation is to test the precision of auditory evoked responses (AERs) to     provide a prognosis for improvement in aphasia subsequent to a left hemisphere thromboembolic     infarct. We hypothesize that the presence, absence, and pattern of the AER responses will     predict severity of aphasia and prognosis for improvement. Phonemic, phonologic, semantic,     and syntactic language tasks will be used to elicit AERs, including the auditory late     response, the mismatch negativity response (MMN), the N400, and the P600.   "
167022|NCT00013455|"     The purpose of this study is to examine and relate physiological, behavioral, and     self-perceived changes after a period of hearing aid use and as a function of auditory     training. The project will focus on the following questions: 1)Is experience-related     behavioral change in hearing aid performance reflected as a neurophysiologic change? 2)Does a     neurophysiologic change occur prior to or in conjunction with an experience-related     behavioral change? 3) Does behavioral training modify the neurophysiologic representation of     speech following the provision of hearing aids? 4)What is the relationship between     physiologic, behavioral,and self-perceived change impacted by behavioral training? 5)Are     neurophysiologic changes limited to trained stimuli or does auditory training alter     neurophysiological responses?   "
167023|NCT00013468|"     Tinnitus is a prevalent issue for veterans who are proportionally more hearing-impaired than     the civilian population.      This study will be conducted as three concurrent projects designed to develop an efficient     clinical technique to quantify tinnitus perception:      (1)Laboratory development of the automated technique for comprehensive tinnitus     quantification;(2)Development of a technique to test for tinnitus malingering; and     (3)Evaluation of the automated technique in the clinical environment.   "
167024|NCT00013481|"     This study will determine whether a therapeutic exercise program for improving motor     coordination in locomotor tasks in post-stroke, hemiparesis patients will result in CNS     recovery. The study will develop relationships between the improved motor performance and     motor coordination during the locomotor task and the functional effects of the exercise     program(e.g., gait variables.)   "
167025|NCT00013494|"     For hemiplegic, stroke patients wheelchair transfers is a critical, safety-related area of     physical function.      This project will develop a personalized training and clinical assessment instrument based on     the Video-Based F-PAT (Functional Performance Assessment and Training.) The objectives of the     study are: (1) Enhance the pilot F-PAT web site to allow clinicians password-protected access     to the digitized video and assessment information; and (2) train an Occupational Therapist     collaborator to create the personalized videotapes for patients to take home with them. This     study has the dual goal of evaluating the effectiveness of the personalized training     videotapes and the effectiveness of the video-based assessment methodology.   "
167026|NCT00013507|"     This research on Functional Incidental Training ( FIT) primarily involves women residing in     community nursing homes. It is an individualized rehabilitative protocol intended to improve     mobility, endurance, strength and continence in frail, older, functionally impaired and     disabled veterans.      Objectives of the project are as follows:      1) Test the effects of FIT on transfer ability, continence, ambulation/mobility, balance and     fall risk, strength, and endurance; 2) Determine the characteristics of NHCU residents who     respond to FIT; 3)Identify the most sensitive outcome measures related to FIT; and 4)     Determine the labor costs of FIT relative to usual care.   "
167027|NCT00013520|"     The purpose of this study is to compare the effectiveness, safety, and tolerability of 3     anti-HIV combination treatments that do not use protease inhibitors (PIs).      The current rule for starting treatment of HIV infection is to combine members from different     classes of anti-HIV drugs, such as 2 nucleoside reverse transcriptase inhibitors (NRTIs) and     either a PI or a nonnucleoside reverse transcriptase inhibitor (NNRTI). However, these     combinations can be complicated and difficult to take, can cause a number of side effects,     and may become ineffective. Combinations that are simpler, better tolerated, and more     effective are needed. Because PIs can cause long-term side effects and because HIV can become     resistant to many of them at the same time, anti-HIV combination treatments that do not use     PIs are being tested.   "
167028|NCT00013533|"     Background:        -  Allogeneic blood and marrow stem cell transplantation (BMT) plays an important role in          the curative treatment of a number of pediatric malignancies. Unfortunately, the success          of conventional allogeneic BMT is limited in part by the multiple toxicities associated          with myeloablative preparative regimens.        -  Non-myeloablative pre-transplant regimens are associated with less toxic side effects          than standard BMT. Recently, a novel immunosuppressive, non-myeloablative pre-transplant          chemotherapy regimen has been shown to facilitate complete donor engraftment in an adult          trial at the NCI.      Objectives:      The primary objective of this protocol is to evaluate the efficacy and safety of this     treatment approach in pediatric patients with hematopoietic malignancies      Eligibility:      Inclusion Criteria      Age: Patient must be greater than or equal to 5 years and less than 22 years of age.      Diagnosis:        -  Hodgkin s and Non-Hodgkin s Lymphoma: Refractory disease or relapse after salvage          regimen.        -  Acute Myelogenous Leukemia: History of bone marrow relapse in remission (CR) #2 or          greater.        -  Acute Lymphocytic Leukemia: History of bone marrow relapse in CR #2 or greater (CR#1          with Philadelphia chromosome positive or prior induction failure).        -  Acute Hybrid Leukemia including mixed lineage, biphenotypic and undifferentiated:          History of bone marrow relapse in CR #2 or greater (CR#1 with Philadelphia chromosome          positive or prior induction failure).        -  Myelodysplastic Syndrome: RAEB or RAEB-t with less than 10% blasts in marrow and blood.        -  Chronic Myelogenous Leukemia: Chronic phase or accelerated phase with less than 10%          blasts in marrow and blood.        -  Juvenile Myelomonocytic Leukemia: less than 10% blasts in marrow and blood.      Prior Therapy: Chemotherapy to achieve above criteria allowed. Prior BMT allowed as long as     at least day 100+ post-prior BMT, no evidence of GVHD, and no detectable residual donor     chimerism.      Donor: First degree related donors, who are HLA matched (single HLA-A or B locus mismatch     allowed), weight greater than or equal to 15 kilograms, and who meet standard donation     criteria will be considered. The same donor from a prior BMT is allowed.      ECOG Performance Status: 0, 1, or 2. and life expectancy: greater than 3 months.      Liver Function: Serum direct bilirubin less than 2.0 mg/dL and serum ALT and AST values less     than or equal to 2.5x upper limit of normal. (Values above these levels may be accepted if     due to malignancy.)      Renal Function: Age adjusted normal serum creatinine or Cr clearance greater than or equal to     60 mL/min/1.73 m(2).      Pulmonary Function: DLCO greater than or equal to 50%.      Cardiac Function: LVEF greater than or equal to 45% by MUGA or LVSF greater than or equal to     28% by ECHO      Exclusion Criteria        -  Active CNS malignancy: Tumor mass on CT or leptomeningeal disease. (Patients with a          history of CNS involvement and no current evidence of CNS disease are allowed.)        -  HIV infection, active hepatitis B or C infection: HbSAg or HCV seropositive and elevated          liver transaminases.        -  Fanconi Anemia.        -  Lactating or pregnant females.      Design:      Pilot Study        -  Initial evaluation: Patient and donor will be screened for eligibility. G-CSF primed          bone marrow derived stem cells will be collected from the donor.        -  Induction/Consolidation chemotherapy: 1 to 3 cycles will be given every 22 days          depending on disease response, CD4 count, and toxicities.        -  Lymphoma: fludarabine, etoposide, doxorubicin, vincristine, cyclophohamide, prednisone,          and filgrastim (EPOCH-fludarabine).        -  Leukemia and MDS: Fludarabine, cytarabine, and filgrastim (FLAG).        -  Transplantation: Fludarabine and cyclophosphamide will be administered over 4 days          followed by bone marrow transplant. Patients will remain hospitalized until bone marrow          recovery. Patients will be monitored closely at the NIH for at least 100 days post-BMT.        -  Post-transplant CNS prophylaxis for ALL: Standard post-transplant CNS prophylaxis will          be employed with intrathecal methotrexate to decrease the risk of CNS relapse for all          patients with ALL.        -  Total number of recipient and donors to be accrued is 56.   "
167029|NCT00013546|"     This study will evaluate the effects of hormone replacement therapy on patients with Turner     syndrome (TS)-a genetic disorder in females in which part or all of one X chromosome is     missing. Most girls and women with TS have underdeveloped ovaries-the female reproductive     organs that produce the female sex hormones estrogen and progesterone, and smaller amounts of     the male sex hormone, testosterone. These hormones affect muscle and bone strength, sex     drive, energy, and an overall sense of well being. Estrogen may also play a role in memory     and mood and have a protective effect against heart disease. Women with TS have a much higher     risk of developing osteoporosis (loss of bone density), high blood pressure, high cholesterol     and diabetes than women without this disorder.      Girls and women with Turner syndrome between the ages of 14 and 50 years may be eligible for     this 2-year study. Three months before beginning treatment, all patients will wear an     estrogen patch and take a progesterone tablet daily for 10 days each month. They will then be     randomly assigned to one of two treatment groups to compare the effects of estrogen alone     with estrogen plus testosterone on bone strength, muscle and fat mass and psychosocial well     being. Both groups will wear an estrogen patch and take oral progesterone. One group will     also wear a testosterone patch while the other group will wear a placebo patch (a patch that     does not contain any testosterone). Neither study participants nor the doctors will know who     is getting the testosterone until the study is complete. Patients will undergo the following     procedures before beginning treatment and at 6, 12 and 24 months after starting treatment:        -  Physical examination.        -  DEXA scans (dual energy X-ray absorptiometry) to measure body composition and bone          thickness. Low radiation X-rays scan the whole body to measure fat, muscle and bone          mineral content..        -  Magnetic resonance imaging (MRI) scan of the abdomen to measure the amount of fat around          the internal organs. The patient lies on a stretcher in a large tube surrounded by a          magnetic field during the scanning. The procedure uses a strong magnet and radio waves          to produce the images.        -  Heel ultrasound to measure bone thickness. The heel is placed in a chamber and sound          waves pass through it to produce images.        -  Oral glucose tolerance test (OGTT) for diabetes and problems with carbohydrate          metabolism. The patient drinks a sugary substance. A small amount of blood is drawn          before taking the drink and four times afterwards.        -  Blood and urine tests to measure blood counts, liver and kidney function, ovarian          hormones, growth factors, thyroid function, blood lipids, bone strength markers, and to          test for pregnancy.        -  Blood pressure measurements.        -  Psychological testing for the effect of treatment on mood, self-esteem, quality of life,          social shyness, anxiety and sexual function.        -  Neurocognitive tests (at first inpatient visit and 1 and 2 years after starting          treatment) to measure nonverbal memory and visual-perceptual abilities.      During the hospital admissions, patients will be given a metabolic diet that contains     specific amounts of salt and carbohydrates to ensure accurate blood pressure and sugar     metabolism measurements. Patients will keep a record of their menstrual periods and physical     activity throughout the treatment period.   "
167030|NCT00013559|"     This study will examine how a rare disease called Smith-Magenis syndrome (SMS) affects people     and how they change over time. SMS is caused by a small chromosome 17p11.2 deletion (missing     piece). The syndrome is associated with distinct physical, developmental and behavioral     characteristics, but it is not fully understood. To learn more about this disease, a     multidisciplinary research team will study:        -  The range and type of medical, behavioral, and learning problems of people with SMS        -  The deletion of chromosome 17p11.2 to find the gene or genes that cause SMS        -  Whether certain specific genetic changes cause certain specific medical problems        -  What signs and symptoms must be present to make a diagnosis of SMS        -  The impact that a child with SMS has on his or her family members.      Patients of all ages with SMS may be eligible for this study. They will be evaluated by a     team of medical specialists at the NIH Clinical Center over the course of several days.     Parents of patients will be asked to provide copies of past medical records and tests results     for review. They will provide a family medical history and information on the child s     prenatal, developmental, behavioral and medical histories.      The study may involve the following evaluations: physical, neurological and psychological     exams; ear, nose and throat evaluation; speech, language and swallowing evaluation; hearing     test; eye examination; imaging studies (e.g., X-rays, ultrasound, MRI); developmental and     behavioral assessment; rehabilitation evaluation with gait (walking) analysis; urinalysis,     blood, and/or skin cell studies; sleep study; other consultations as required. A tissue     sample (blood or cheek swab or skin biopsy) may be taken for genetic studies. To obtain a     cheek swab, a small brush is rubbed against the inside of the cheek to wipe off some cells.     For a skin biopsy, a small area of skin is numbed with a local anesthetic and a small circle     of skin, usually about 1/8 inch, is removed with a biopsy tool. Parents may be asked to     complete questionnaires about their child s growth and development, therapies, medications,     sleep, development and behavioral concerns. They also may be asked to bring their child to     NIH for follow-up visits every 6 months to 3 years, depending on the child s age. The purpose     of these visits is to see how the child changes over time and to conduct additional tests.      Parents may also be asked to enroll their child in a SMS Research Registry and provide tissue     samples for a SMS Research Core Tissue Bank. The research registry is a confidential database     of individuals diagnosed with SMS. Its purpose is to facilitate SMS research initiatives and     promote the development of improved treatments for SMS. Enrollment requires completing a     30-minute questionnaire. The tissue bank stores tissue cultures and cell lines created for     future SMS research. About 2 teaspoons of blood are drawn from adult patients and 1 to 3     teaspoons from children, depending on their size. Tissue samples can be obtained by skin     biopsy or during a scheduled surgical procedure.   "
167031|NCT00013572|"     The purpose of this study is to determine the best way to administer the candidate HIV     vaccine, ALVAC HIV-1 (vCP205).   "
167032|NCT00013585|"     A decrease in mental function often occurs in patients with HIV. Antiretroviral (ARV) drugs     are used to treat this but are not entirely effective. Some other therapy could play a role.     The drug selegiline in its pill form is used to treat Parkinson's disease, a serious brain     disorder. It is believed this drug might protect the brain and repair some damage. This study     will use this drug in a patch form, which has not been approved by the Food and Drug     Administration (FDA), to see if it helps with decreased mental function in patients with HIV.     The purpose of this study is to evaluate the use of selegiline transdermal system (STS) in     the treatment of decreased mental function in patients with HIV.   "
167033|NCT00013598|"     This study will evaluate the effectiveness of pioglitazone, a new diabetes medicine, on     decreasing insulin resistance and improving liver disease in patients with nonalcoholic     steatohepatitis (NASH). NASH is a chronic liver disease with unknown cause that involves fat     accumulation and inflammation in the liver, leading to liver cirrhosis in 10 to 15 percent of     patients and significant liver scarring in another 30 percent. Although similar to a     condition that affects people who drink excessive amounts of alcohol, NASH occurs in people     who drink only minimal or no alcohol. It is most often seen in patients with insulin     resistance. Pioglitazone decreases insulin resistance and improves blood lipid (fat) levels,     so that it may improve liver disease in NASH.      Patients with NASH 18 years of age or older may be eligible for this study. Candidates will     be screened with a medical history and physical examination and routine blood tests. They     will see a dietitian for counseling on diet and weight reduction, if needed. They will stop     taking any medications for liver disease and take a daily multivitamin pill. After 2 months,     those eligible for participation will be enrolled in the study.      Participants will be admitted to the Clinical Center for 2 to 3 days for a complete medical     history, physical examination, blood tests, urinalysis, chest X-ray, electrocardiogram,     abdominal ultrasound and a liver biopsy. After the diagnosis of NASH is confirmed, the     following procedures will be performed:        -  Echocardiography - imaging test using sound waves shows the heart structure and function        -  Resting metabolic rate - measures amount of oxygen (and calories) used to maintain body          functions at rest. While lying down, the patient wears a clear plastic hood over the          head for 20 minutes while the amount of oxygen used is measured.        -  Magnetic resonance imaging (MRI) scans - shows the size of the liver and other organs.          The patient lies on a table in a metal cylinder that contains a magnetic field (the          scanner) for no more than 30 minutes while the organs are imaged.        -  Dual energy X-ray absorptiometry (DEXA) scan measures whole body composition, including          amount of fat. The patient lies under an X-ray scanning machine for about 2 minutes.        -  Oral glucose tolerance test (OGTT) - measures blood sugar and insulin levels. The          patient drinks a very sweet drink containing glucose (sugar), after which blood samples          are collected at various intervals during the 3-hour test. The blood is drawn through a          catheter (thin plastic tube) placed in the arm before the test begins.        -  Intravenous glucose tolerance test (IVGTT) - determines how the tissues respond to          insulin and glucose. Glucose is injected into a vein, followed by a short infusion of          insulin. Blood samples are collected through a catheter at various intervals during the          3-hour test.      When the above procedures are completed, patients start taking pioglitazone by mouth once a     day for 48 weeks, keeping track of the medication and any side effects. They will be seen at     the clinic every 2 weeks for the first month and then every 4 weeks for the rest of the     treatment period. The visits will include an interview and examination by a physician and     blood draw for laboratory tests. Female patients will have a pregnancy test at each clinic     visit. At the end of the treatment period patients will be admitted to the Clinical Center     for a repeat medical evaluation that will include the procedures described above.   "
167049|NCT00013819|"     This is a study of the effects that lead has on the health of the central nervous system (for     example, memory), peripheral nervous system (for example, sensation and strength in the hands     and fingers), kidneys, blood pressure, and the blood forming system. A total of 803 lead     workers and 135 persons without occupational lead exposure are being studied in South Korea.     Lead in the body is being assessed by measurement of blood lead, chelatable lead (an estimate     of lead in the tissues), and lead in bone. Subjects are tested three times each over three     years. Several genetic factors are also being assessed for the role they play in the health     effects of lead. These genes are known to differ among individuals. We are interested to know     whether different forms of the same genes can modify the effect lead has on health.   "
167081|NCT00020904|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating women who have     stage IV or recurrent metastatic breast cancer.   "
167034|NCT00013611|"     This study will examine whether interleukin-2 (IL-2) plus antiretroviral therapy (ART) slows     HIV disease progression in patients with low CD4+ T cell counts compared with patients taking     ART alone. CD4+ T cells are a subset of lymphocytes-white blood cells that are part of the     body's immune system. IL-2 is a protein that is naturally produced by lymphocytes. Given in     intermittent cycles, IL-2 can raise CD4+ T cell counts in some HIV-infected patients taking     antiretroviral drugs. This study will examine whether the increase in CD4+ T cells lowers the     risk of AIDS-related illnesses and death.      HIV-infected patients 18 years of age and older with a viral load under 10,000 copies per     milliliter and a CD4+ T cell count between 50 and 299 cells per cubic millimeter who are     taking antiretroviral therapy and who have not previously received IL-2 therapy may be     eligible for this study. Candidates will be screened with a medical history, physical     examination, and blood and urine tests. Participation in the study will be from 4.5 to 6     years, depending on what point in the duration of the study the individual patient is     enrolled.      Patients will be randomly assigned to receive IL-2 plus ART or ART alone. All participants     will be advised individually about the best ART regimen for them. Patients in the IL-2     treatment group will be taught how to self-inject IL-2 under the skin (similar to insulin     injections). They will inject IL-2 twice a day for 5 days every 8 weeks for the first year     (until week 49 of the study). From week 49 on they may receive 5-day cycles of IL-2 every 4     months when needed to maintain CD4+ T cell count elevations. An extra cycle may be given 2     months after the week 49 follow-up visit (see follow-up schedule below), depending on their     CD4+ T cell count. Patients whose cell counts have not increased after 12 to 16 months of     IL-2 treatment will discuss with the doctor the possibility of stopping IL-2. Those who do     stop IL-2 treatment will be asked to remain in the study for follow-up evaluations.      All patients will be followed in the clinic every 2 months for the first year of the study     (weeks 1, 9, 17, 25, 33, 41 and 49) and every 4 months during years 2-6 for a brief history     and physical exam, urine and blood tests, return of diary cards (record of drug side effects)     and medication review. During the visits from the second year on, patients will also be asked     about their ability to do certain ordinary tasks, such as taking care of themselves; ...   "
167035|NCT00013624|"     This study will evaluate the effects of the drug riluzole on Parkinson's disease symptoms and     on dyskinesias (involuntary movements) that develop as a result of long-term treatment with     levodopa. Riluzole blocks the action of the chemical messenger glutamate, thought to be     involved in producing Parkinson's symptoms. The drug is currently approved to treat     amyotrophic lateral sclerosis, another neurologic condition.      Patients with relatively advanced Parkinson's disease between 20 and 80 years of age may be     eligible for this 4-week study. Participants will have a complete medical history and     physical examination, and a detailed neurological evaluation. The evaluations will include     blood tests and an electrocardiogram, and possibly brain magnetic resonance imaging (MRI), CT     scan, and chest X-ray.      Participants will, if possible, stop taking all antiparkinsonian medications except levodopa     (Sinemet) for one month before the study begins and throughout its duration. For the first 1     to 3 days, patients will be admitted to the NIH Clinical Center to undergo a levodopa     dose-finding procedure. For this study, patients will stop taking their oral Sinemet and     instead will have levodopa infused through a vein for up to 8 hours/day. During the     infusions, the levodopa dose will be increased slowly until either 1) parkinsonian symptoms     improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached.     Symptoms will be monitored frequently to find two infusion rates: 1) one that is less than     what is needed to relieve symptoms (suboptimal rate), and 2) one that relieves symptoms but     may produce dyskinesias (optimal rate).      When the dose-finding phase is completed, treatment will begin. Patients will take riluzole     or placebo (a look-a-like pill with no active ingredient) twice a day, along with their     regular Sinemet, for 3 weeks. (All participants will receive placebo at some time during the     study, and some patients will receive only placebo throughout the entire 4 weeks.) At the end     of each week, patients will be readmitted to the hospital and receive the previous week's     dose of riluzole or placebo in combination with a levodopa infusion at the rate determined in     the dose-finding phase of the study. The procedure for the infusion will be the same as that     for the dose-finding phase. The dose of riluzole will be increased until the optimum dose has     been achieved or until side effects occur (at which time the dose will be lowered or the drug     stopped).      Throughout the study, parkinsonian symptoms and dyskinesias will be evaluated using     standardized rating scales and blood samples will be drawn periodically to measure drug     levels.   "
167036|NCT00013637|"     This study's primary objective is to assess the effects of environmental lead exposures and     genetic risk factors on the development of osteoporosis in middle-aged women.   "
167037|NCT00013650|"     The purpose of this study is to evaluate the effects of the drug cyclophosphamide (CY) on     inflammation and immune responses in individuals with Alzheimer's Disease (AD).      Inflammation and immunologic response appear to contribute to neurodegeneration in people     with AD. In a process called gliosis, the brain immune cells microglia and astroglia undergo     activation and possible proliferation, which promotes neuronal injury and death. Activated     microglia and astroglia produce compounds that are cytotoxic to neurons, and they express     molecules that greatly amplify immune and inflammatory processes in the brain. Excessive     glial activation and proliferation are thought to be pivotal events that hasten the demise of     synapses and neurons in AD. Fortunately, increased understanding of immune and inflammatory     pathology in AD has provided new opportunities for designing disease-altering treatments for     AD. Studies suggest that medications such as nonsteroidal anti-inflammatory drugs (NSAIDs)     and immunomodulatory agents may have an important role in altering the course of AD. CY is a     potent anti-inflammatory and immunomodulatory drug that inhibits proliferation of immune     cells. This study will evaluate the effects of CY on individuals with mild to moderate AD.      Participants in this study will be randomly assigned to receive either two different doses of     CY or placebo (an inactive pill) for 6 months. Participants who receive placebo during the 6     months will have the option of receiving CY for an additional 6 months. Participants will     undergo magnetic resonance imaging (MRI) scans of the brain. Measures of cerebral spinal     fluid biomarkers or neurodegeneration, neuroinflammation, and neuroimmune activation will be     taken. In addition, peripheral lymphocyte subsets and peripheral markers of inflammation will     be assessed.   "
167038|NCT00013663|"     The purpose of this study is to determine if HIV-specific canarypox vaccine and/or     interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment     is withdrawn for a certain time period.   "
167039|NCT00013689|"     This study will evaluate the safety and effectiveness of an antibiotic called Fansidar on     autoimmune lymphoproliferative syndrome (ALPS). Patients with ALPS have enlarged lymph     glands, spleen and/or liver, abnormal blood cell counts and overactive immune function.     Current treatments are aimed at suppressing the immune system and improving symptoms, such as     anemia (low red blood cell count) and low white blood cell and platelet counts. These     treatments, however, are only partially effective and may have complications. Fansidar is a     combination of two drugs, sulfadoxine and pyrimethamine, that is used to treat or prevent     parasitic infections such as malaria. Recently a child with ALPS who was treated with     Fansidar for a different illness had a marked shrinkage of the lymph organs. This study will     examine whether Fansidar can shrink the lymph glands or spleen in patients with ALPS.      Patients with ALPS between the ages of 4 and 70 years who have had lymph gland enlargement     for at least 1 year and are not allergic to sulfa drugs may be eligible for this study.     Candidates will be screened with a medical history and physical examination and blood tests.     Females of reproductive age will have a urine pregnancy test.      Participants will be evaluated at the NIH Clinical Center in Bethesda, MD, with blood tests     and a computed tomography (CT) scan of the lymph nodes. For the CT scan, the patient lies on     a table during an X-ray scan of the neck, part of the chest, and, if the spleen has not been     removed, the stomach area.      When these baseline tests are completed, patients will be given Fansidar pills to take once a     week for 12 weeks. The dosage will be increased after 2 weeks and again after 4 weeks. At 2,     4, 6, 8 and 10 weeks after starting the treatment and 2 weeks after the last dose, patients     will have blood drawn to check for possible side effects of therapy. Women will have a repeat     urine pregnancy test at week 6 of treatment.      Within a week before completing treatment or after completing treatment, patients will return     to NIH for a history, physical examination, blood tests and CT scan. Patients who responded     well to treatment will be offered to return to NIH again 3, 6 and 12 months later to repeat     the evaluations. If ALPS symptoms recur during this time, patients will be offered another     12-week course of Fansidar and the procedure, including the 3, 6 and 12-month evaluations     will be repeated again. If symptoms recur again, patients will be asked to resume Fansidar     for 6 months or longer, with doses adjusted as needed. During this time, patients will be     seen at NIH every 12 weeks for evaluation and blood will be drawn by the patient's private     physician every 6 weeks or 2 and 4 weeks after the dose is increased to check for side     effects.   "
167128|NCT00024531|"     The purpose of this study is to assess the clinical benefit of Lipitor, a     cholesterol-lowering drug, in the treatment of Alzheimer's disease.   "
167040|NCT00013702|"     This study will evaluate the safety and effectiveness of adding the experimental drug     adefovir dipivoxil to lamivudine for treating hepatitis B virus (HBV) infection in     HIV-infected patients with liver cirrhosis. Adefovir inhibits HBV by interfering with     replication of the virus's genetic material. In some people, the drug has been active against     strains of HBV that are resistant to lamivudine; it may also have some activity against HIV.      HIV-infected patients 21 years of age and older with chronic hepatitis B infection and liver     cirrhosis who have received lamivudine treatment for at least 1 year may be eligible for this     48-week study. Candidates will be screened with a complete medical history, blood tests and a     24-hour urine collection. Blood tests include HLA typing (a test of genetic markers on white     blood cells that permit specialized immunology studies). Within 4 weeks, candidates who     appear eligible for the study will have a physical examination and medical history, an     abdominal ultrasound (imaging test using sound waves) to check for cancer of the liver, chest     X-ray and electrocardiogram (EKG). Blood and urine tests will also be done, and women who can     become pregnant will have a pregnancy test.      Patients who meet the study criteria and decide to participate will then start treatment with     one 10-mg adefovir pill per day by mouth. In addition, patients will continue to take all     other medications prescribed by their doctor. Follow-up clinic visits will be scheduled as     follows:        -  Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for specialized immunology tests and to          measure blood levels of HIV and HBV.        -  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 - Blood and urine (single sample)          tests will be done to determine the side effects of adefovir and its effect on the HBV          infection.        -  Week 48 or early termination (end of study) - Blood tests (including tests for hepatitis          C and D), abdominal ultrasound and a 24-hour urine collection to evaluate kidney          function will be done.        -  Monthly visits beyond week 48 - Based on the HBV response to treatment and the          availability of the drug from the sponsor, patients may be offered to extend their          treatment with adefovir. Those who continue will have monthly follow-up visits for blood          and urine (single sample) tests.   "
167041|NCT00013715|"     In the U.S., morbidity associated with human rhinovirus (RV) infection represents a major     health problem. In asthmatics, up to 80% of asthma exacerbations are associated with upper     respiratory infections. Despite evidence that environmental oxidant pollutants, such as     ozone, may increase the severity of viral disease, the mechanisms underlying such an effect     have not been identified. This study will test the hypothesis that exposure of allergic     asthmatic subjects to ambient levels of ozone directly enhances viral disease by increasing     infectivity and intensifying virus-induced inflammation.   "
167042|NCT00013728|"     We are testing the following two hypotheses: 1) Peaks in hourly exposures to airborne     particulate matter (PM) of outdoor origin will be more closely associated with acute     asthmatic responses to particles than 24-hour average exposures in susceptible individuals;     2) Personal exposure to PM, and estimated particle dose to the lungs, will be more closely     associated with daily asthma severity than standard outdoor particle concentrations measured     as 24-hour averages at governmental monitoring sites.   "
167043|NCT00013741|"     The purpose of the study is to examine ways in which a clinical information system can help     patients better recognize the signs and symptoms of an acute myocardial infarction (heart     attack) and to take actions to decrease morbidity and mortality that may be related to delay     in seeking treatment. The software-based intervention will use the best scientific evidence     to create tailored strategies using a patient's specific health data. This approach is based     on well-established cognitive and behavioral educational models.   "
167044|NCT00013754|"     This project is aimed at better understanding how children living in agricultural     environments are exposed to pesticides, and how such exposures can be prevented or reduced.     The current project will characterize pesticide exposure pathways for children of     farmworkers.   "
167045|NCT00013767|"     This project is aimed at better understanding how children living in agricultural     environments are exposed to pesticides, and how such exposures can be prevented or reduced.     The project will develop and implement a community-wide intervention to reduce the transfer     of pesticides from the workplace to the home (take home pathway).   "
167046|NCT00013780|"     Ozone is an air pollutant formed in at ground level by the chemical reaction between oxygen     and automobile emissions in the presence of sunlight. The objective of this research is to     determine how lung size, chemical composition, and normal functioning of the respiratory     system affect the amount of inhaled ozone that reaches internal sites of tissue irritation     and damage. To infer the distribution of inhaled ozone within the respiratory system,     measurements of ozone concentration and air flow are made just outside the nose and mouth of     healthy subjects who breathe laboratory-generated, ozonated air for about one hour.     Biochemical composition of respiratory mucus is then inferred from nasal washings made with     salt water. The amount of ozone that a subject retains in one of these experiments is less     than the daily exposure in a large city such as New York or Los Angeles.   "
167047|NCT00013793|"     The primary purpose of this randomized clinical trial is to test the efficacy of motivational     enhancement (ME) therapy combined with biologic feedback (fetal ultrasound) for increasing     smoking quit rates among low-income pregnant women considered resistant smokers. We     hypothesize that ME along with biofeedback will increase the rate of validated smoking     cessation at 8 months gestation by at least 10 percentage points above that produced by Best     Practice (BP) counseling alone. This study will also examine reduction of smoking among     non-quitters and maintenance of smoking cessation through 6 weeks postpartum among women who     quit.      Prenatal smoking is the leading preventable cause of low birth weight in the US. Reduction in     smoking during pregnancy could result in significant improvements in pregnancy outcomes and     reducing the cost of health care. There is evidence that low-intensity pregnancy smoking     cessation programs may be inadequate for women who are more addicted, and at educational and     economic disadvantage. Motivational enhancement strategies have shown considerable promise in     the treatment of addictive behaviors. Physiological feedback highlighting prenatal effects of     smoking and benefits of cessation has been found to enhance prenatal smoking cessation     counseling. An intervention that combines motivational enhancement counseling and     physiological feedback may have powerful effects beyond low-intensity interventions or usual     counseling.   "
167048|NCT00013806|"     131I-metaiodobenzylguanidine (131I-MIBG) is a norepinephrine analog that concentrates in     adrenergic tissue and therefore holds promise for cell-specific treatment of neuroblastoma.     This is a dual institution, Phase II study of 131I-MIBG administered at the previously     defined maximum practical dose of 18 mCi/kg to children with relapsed or refractory     neuroblastoma.   "
167078|NCT00014222|"     RATIONALE:        1. . To compare the effects on breast cancer of three different combinations of drugs which          are commonly used to treat this disease.        2. . It is not yet known which treatment regimen is most effective for breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     given with or without epoetin alfa in treating women who have undergone surgery for stage I,     stage II, or stage III breast cancer.   "
167050|NCT00013832|"     This study will examine tongue strength and endurance, how the tongue applies pressure during     swallowing, and how the chin muscles react during swallowing in healthy volunteers and in     patients with dysphagia (difficulty swallowing). The information from this study may be     helpful in developing better treatments for people with swallowing problems.      Healthy volunteers who have no history of speech, swallowing or breathing problems and     patients who have difficulty swallowing because of a neurologic disorder, musculoskeletal     disease or head and neck cancer that caused tongue weakness and dysphagia may be eligible for     this study. Such medical conditions may include stroke, Parkinson's disease, multiple     sclerosis corticobasal degeneration, progressive supranuclear palsy, Gaucher's disease,     leukodystrophy, cerebral palsy, myositis, or mouth, throat or neck cancer. Volunteers who     have not participated in a NIH protocol for 1 year will be screened with a brief medical     history and physical examination. Dysphagic patients not currently enrolled in a NIH protocol     will also have a brief medical history and physical examination. In addition, they will have     a modified barium swallow to determine the nature and degree of their swallowing difficulty.      Participants will have a 15-minute examination of movements of their tongue, lips and jaw and     will fill out a questionnaire about their swallowing ability. They will then begin the tongue     pressure test. To monitor and record tongue pressure, a thin rubber strip with air-filled     pressure bulbs will be attached to the roof of the mouth with dental adhesive. The pressure     bulbs are connected to an external pressure-reading device. In addition, a small plastic pad     with adhesive backing will be placed under the chin. Electrodes (wires) attached to the pad     record chin muscle activities.      With the pressure bulbs and chin electrodes in place, the patient will perform tongue     pressure tasks to test tongue strength, how long the patient can maintain a certain tongue     pressure, and how fast tongue pressure drops. The tasks include saliva swallows, water     swallows and cup-drinking.   "
167051|NCT00013845|"     This protocol has three purposes: 1) to screen patients with seizures for participation in     research studies of NINDS s Clinical Epilepsy Section (CES), 2) to follow the natural course     of seizure disorders, and 3) to train CES fellows in evaluating and treating epilepsy. Only     standard diagnostic tests and treatments will be used in this study.      Patients of any age with seizures who are referred to CES may participate in this study. At     the end of the study, patients may be discharged to the care of their referring physician,     offered participation in another NINDS research protocol, or followed for teaching purposes.      Participants will undergo standard diagnostic procedures used to determine the type of their     seizures, what part of the brain they are coming from, what is causing them, and whether     standard drug treatments can help them. These may include some or all of the following:        -  Physical and neurological examination        -  Neuropsychological tests tests of learning and memory        -  Electroencephalography (EEG) brain wave recording        -  Evoked potentials tests of nerve reactions to lights and sounds        -  Polysomnography simultaneous recordings of brain waves, breathing and eye movements        -  Video-EEG monitoring simultaneous recording of seizures using a video camera and brain          waves        -  Video-EEG monitoring with extra electrodes to record muscle activity, breathing and eye          movements for analyzing sleep patterns        -  Imaging studies, such as magnetic resonance imaging (MRI) and positron emission          tomography (PET) scans to examine the structure and function of the brain        -  Frequent blood tests to measure blood levels of anti-seizure drugs   "
167052|NCT00013858|"     This study is designed to examine the effects of prenatal exposure to environmental     contaminants on cognitive and behavioral development and physical growth in two groups of     Inuit infants-one in Northern Quebec; the other in Greenland.   "
167053|NCT00013871|"     The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV)     followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on     anti-HIV therapy is helpful and safe in fighting pneumococcal infections in this group of     children. This study will also look at the protection provided by childhood vaccination     against measles, pertussis, and hepatitis B virus.      Pneumococcal infections are the most common AIDS-related infection in HIV-infected children.     PCV may help reduce the chances of HIV-infected children getting pneumococcal infections.     This study will look at whether pneumococcal vaccines are safe and effective in HIV-infected     children receiving HAART. It will look at whether HIV-infected children are protected by     childhood vaccines received previously and if more doses are safe and improve protection.   "
167054|NCT00013884|"     This study will evaluate whether a drug called T-20 can slow or prevent a rapid return of HIV     in the blood when HAART (highly active antiretroviral therapy) is stopped temporarily. HAART     is a multi-dose regimen that is very effective in suppressing HIV and perhaps slowing or     halting progression of the viral infection towards AIDS. However, this treatment is not     problem-oriented. It cannot completely rid the body of virus, and long-term therapy carries a     risk of toxicity (harmful side effects). Moreover, the treatment is difficult to adhere to     because of the many pills and capsules that must be taken daily. When patients stop taking     HAART, their viral levels climb again. This study will see if T-20 can prolong the time it     takes for HIV blood levels to rise in patients who stop HAART temporarily. The results may     provide insight into possible new HAART-sparing treatments.      HIV-infected patients 18 years of age and older who have received HAART for at least 1 month     may be eligible for this study. Candidates will be screened with a medical history, physical     examination, blood and urine tests and possibly a chest X-ray and electrocardiogram (EKG).      Participants will receive either 100 Mg. of T-20 twice a day or 200 Mg. once a day, injected     under the skin, and their normal HAART regimen for 3 days. (Patients or a caregiver will be     taught how to give the T-20 injections.) On the fourth day, HAART will be stopped and all     patients will receive 100 Mg. of T-20 twice a day for 6 weeks. Blood will be drawn weekly     from the second to the sixth week after stopping HAART to check viral levels and CD4+ T cell     counts. At the end of the 6 weeks, T-20 will be stopped and HAART will be restarted. Patients     will then be evaluated once a month until their viral level is less than 50. The final clinic     visit will be one month after this time.      In addition to blood draws, patients will undergo leukapheresis before beginning T-20 and     possibly again when they restart HAART and at the end of the study. For this procedure, whole     blood is collected through a needle placed in an arm vein, similar to donating blood. The     blood circulates through a machine that separates it into its components. The white cells are     then removed, and the red cells, platelets and plasma are returned to the body, either     through the same needle used to draw the blood or through a second needle placed in the other     arm. The white cells are used to study T cell function and levels and to detect hidden virus.   "
167055|NCT00013897|"     The purpose of this study is to compare the effectiveness of treatment with BMS-232632 to     that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC).   "
167062|NCT00014001|"     The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention     Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the     long-term effects and usefulness of antipsychotic medications in persons with schizophrenia.     It is designed for people with schizophrenia who may benefit from a medication change. The     study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone,     clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine     decanoate). All participants will receive an initial comprehensive medical and psychiatric     evaluation and will be closely followed throughout the study. For most participants the study     will last up to 18 months. Everyone in the study will be offered an educational program about     schizophrenia and family members will be encouraged to participate.   "
167079|NCT00020878|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco     smokers.      PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell     lung cancer in tobacco smokers.   "
167056|NCT00013910|"     The purpose of this research study is to investigate the mechanism of action of a new     investigational medication (drug), NNC 90-1170, which is being developed for the treatment of     type 2 diabetes (adult onset type of diabetes.      NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or GLP-1), which is     important for controlling insulin levels. Insulin, another hormone, is also important for     controlling blood glucose levels, which are higher than normal in people who have type 2     diabetes. This study will measure the effect of NNC 90-1170, active investigational drug, to     cause insulin to be released from the pancreas in response to increasing blood glucose     concentrations. These results will be compared to that of a group of healthy volunteers of     similar age and body weight who do not have diabetes. Also, various other hormones and     substances that are known to control blood sugar will be measured in blood samples that will     be drawn.      One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study,     and the effects of this dose will be compared to a placebo (inactive substance that looks     like the active drug). This is a crossover study, which means that subjects will be treated     both with NNC 90-1170 and with placebo. The order in which subjects will receive the     treatments will be determined by chance (randomly).      The study will be conducted as a so-called double-blind study, meaning that neither     subjects nor study doctors will know the order in which subjects will be given each treatment     until the study is over.      The study will include approximately 15 healthy volunteers and 15 volunteers with type 2     diabetes, and it will be conducted at 1 clinic (the University of Michigan Health System) in     the United States.   "
167057|NCT00013923|"     The purpose of this study is to evaluate the effectiveness of a nutritional supplement that     has been developed to improve the brain function of a patient with Alzheimer's disease.   "
167058|NCT00013936|"     The purpose of this protocol is to develop a valid, reliable, better standardized, and more     efficient test of visual acuity (ability to see fine details) for use in clinical trials.     Recent improvements in computer video hardware permit calibration, characterization, and     accurate rendering of eye-chart-quality letters. The computer can then be used to measure     acuity. The modified binary search (MOBS) testing strategy is one method of computer-based     testing. This study will compare the accuracy, precision, stability and utility of the MOBS     technique with the eye chart method used in the National Eye Institute's Early Treatment for     Diabetic Retinopathy Study (ETDRS). The ETDRS method is currently the gold standard for     acuity testing in clinical trials.      Study subjects will include NEI clinic patients between 7 and 90 years of age with or without     eye disease. Eye diseases include poor visual acuity, age-related macular degeneration,     cataract, optic nerve abnormality, corneal abnormality, uveitis, glaucoma, other retinal or     choroid abnormality, amblyopia or other eye disease.      Participants will have their vision tested in each eye using both the ETDRS eye chart method     and the MOBS method. The ETDRS method will require subjects to read all the letters on the     chart until they can no longer see the details. For the MOBS method, they will read a single     letter at a time that will appear on the computer screen. After reading each letter, a new     letter will be presented that is either bigger or smaller in size. After completing the last     acuity test, participants will fill out a questionnaire regarding their preference for one     test type over the other.   "
167059|NCT00013949|"     This project is part of a program project directed toward assessing cardiac effects of     particulate and other ambient air pollutants. In this project active elderly adults living in     the communities of Boston and Steubenville have attended 12 weekly sessions including     approximately 40 minutes of Holter monitoring, blood pressure, and oximetry evaluation     before, during, and after outdoor exercise. To investigate the relation of air pollution to     cardiac and pulmonary rehabilitation, a second portion of this study involves abstraction of     blood pressure and symptom data and downloading of available repeated measures telemetry data     in two populations. These populations include: 1) 200 outpatients attending 8 to 36 repeated     weekly exercise training sessions in a major hospital cardiac rehabilitation unit.   "
167060|NCT00013962|"     The Williams syndrome is a disease in which supravalvular aortic stenosis, an elfin facies,     mental retardation and other congenital defects are sometimes associated with abnormal     vitamin D and calcium metabolism. Whereas some patients have been reported to show increased     sensitivity to vitamin D or an exaggerated response of serum 25-hydroxyvitamin D {25(OH)D} to     administration of vitamin D and to have hypercalcemia caused by increased circulating     1,25-dihydroxyvitamin D{1,25(OH)2D} in infancy and early childhood, most patients have normal     calcium metabolism and normal values for circulating 25(OH)D and 1,25(OH)2D. We propose to     carry out further studies of vitamin D metabolism to elucidate the mechanism(s) for abnormal     vitamin D metabolism. We will determine the response of serum 1,25(OH)2D to administration of     1,25(OH)2D3. Measurement of the 1,25(OH)2D in the patients compared to normal subjects will     be the primary outcome.   "
167061|NCT00013975|"     This study will measure and compare the levels of endothelial progenitor cells (EPCs) in the     blood of people with and without risk factors for atherosclerosis (hardening of the arteries)     to see if there is a relationship between these cells and cardiovascular risk factors such as     smoking, high cholesterol level and high blood pressure.      Healthy male volunteers between the ages of 21 and 55 years with and without heart disease     risk factors may be eligible for this study. Candidates must have no evidence of coronary or     peripheral vascular disease, proliferative retinopathy, or other chronic disease and no     history of cancer, migraine-type headache, cluster headache, raised intraocular pressure,     raised intracranial pressure, hyperthyroidism.      Participants will undergo the following procedures at the NIH Clinical Center:        -  Medical history and physical examination        -  Blood tests to measure EPC level and various risk and growth factors        -  Brachial reactivity study - This ultrasound study tests how well the subject's arteries          widen. The subject rests on a bed for 30 minutes. An ultrasound measuring device is          placed over the artery just above the elbow. The size of the artery and blood flow          through it are measured before and after inflating a pressure cuff around the forearm.          The pressure cuff stops the flow of blood to the arm for a few minutes. After a          15-minute rest, the drug nitroglycerin is sprayed under the subject's tongue. Before the          nitroglycerin spray and 3 minutes after it, the size of the artery and blood flow          through it are measured again.   "
168423|NCT00032760|"     The purpose of this study is to assess the relative effectiveness of a mindfulness     meditation-based intervention for binge eating disorder in comparison to a psycho-educational     intervention and a waiting-list control group.   "
167063|NCT00014014|"     The purpose of this study is to see if the full daily dose of Combivir (zidovudine     [ZDV]/lamivudine [3TC]) taken once a day is as effective as the usual recommended twice-a-day     dose.      Studies have shown that the antiviral activity of ZDV can continue in the body even after     there does not appear to be any ZDV left in the blood. This occurs because the body breaks     down the drug into substances that remain active against HIV. The body also breaks down 3TC,     a drug that is combined with ZDV in the Combivir product, in a similar way. Since antiviral     activity may continue after Combivir is removed from the body, it may not be necessary to     take the drug as often as once thought. This study carefully measures levels of the active     substances in order to find out whether the same amount of antiviral activity occurs with     less-frequent dosing.   "
167064|NCT00014027|"     This research study is designed to find out if increasing the dietary intake of     polyunsaturated fats improves concentration, motor skills and cardiovascular responses under     stress. These polyunsaturated fats may also change the chemicals in the brain that control     these responses. Specifically, these polyunsaturated fats may raise brain levels of     neurotransmitters called dopamine and serotonin. Polyunsaturated fats are important for     improving the function of both the brain and the heart. People cannot make these     polyunsaturated fats and they can only be obtained from the oils that we eat. For three     months subjects will take 8 capsules a day that contain either corn oils flavored with fish     oils or fish oil that taste a little like corn oils. Subjects will not be told which oils we     expect to work better. An initial evaluation will determine if subjects fit the criteria     necessary to enter the study. A battery of tests will be conducted twice, once before     starting the capsules and again after three months of taking the capsules. These batteries of     tests will include an MRI of the head, paper and pencil tests to evaluate changes in mood,     and tests of concentration and motor skills and cardiovascular responses under stress. Two     lumbar punctures will be performed to collect cerebrospinal fluid so that changes in     neurotransmitters can be evaluated. Subjects will be on a no seafood diet to equalize their     dietary intake of polyunsaturated fatty acids. Subjects will be expected to complete all     parts of this study.   "
167065|NCT00014040|"     This study will test whether inhaling nitric oxide gas can improve blood flow to the heart,     ventricular function, exercise tolerance in patients with coronary artery disease and chest     pain that has not improved with medical or surgical therapy.      Patients with coronary artery disease who have chest pain despite treatment with medicines     and angioplasty or surgery may be eligible for this study. Those enrolled will receive     monetary compensation for their participation in this study.      The duration of the study is 5 days, with 2 testing periods lasting 2 days each. During one     of the periods, the study participants will breathe nitric oxide mixed with room air through     a face mask during the tests. During the other period, the participants will breathe room air     alone through a face mask during the tests. At least 1 day will separate the treatment     periods. During each of the 2 treatment periods (nitric oxide and room air), participants     will undergo 4 tests to determine whether the treatment improves the heart's response to     stress with increased heart rate and contraction. Approximately one hour before each of the     tests, participants will breathe either nitric oxide mixed with room air or room air alone     through the face mask, and continue the inhalation treatment while each test is being     performed. The face mask will be removed at the end of each test.      On the morning of the first day of each treatment period, participants will have a special     echocardiogram with imaging of the heart. The echocardiogram will be performed during an     infusion of dobutamine, a medicine that increases heart rate and contraction, and serves to     stress the heart. This manner of stress testing is commonly used in hospitals around the     country to determine if walls of the heart are receiving sufficient blood supply. That     afternoon, participants will undergo a magnetic resonance imaging (MRI) study of the heart.     The MRI will determine the heart's blood flow and contraction while receiving the same dosage     of dobutamine as was used earlier in the day. On the morning of the second day of each     treatment period, participants will exercise on a treadmill until moderately uncomfortable     chest pain is reported. Later that morning, participants will undergo cardiac     catheterization. For the cardiac catheterization, a long tube (catheter) will be placed into     a vein of the neck once the skin is numbed with xylocaine. This tube will be positioned     within the right atrium of the heart and into a tube-like structure called the coronary     sinus, where venous blood exits the heart muscle. A small catheter will also be placed in an     artery of the upper forearm after the skin has been numbed with xylocaine. Blood samples will     be taken to allow us to measure the amount of nitric oxide transported in the blood. The     blood samples will be drawn (through the tube in the heart and through the small tube in the     artery) at the beginning of the study and during infusion of dobutamine to stress the heart.     The dose of the dobutamine infusion will be the same dose used in the previous day's stress     studies.      After the completion of the first treatment period, we will stop testing for at least one     day. Participants will begin the second treatment period with the inhalation treatment not     received during the first treatment period.   "
167066|NCT00014053|"     The purpose of this study is to compare immune system activity in young people and older     people who do not have HIV. This information will be compared to that of HIV patients in     another study.      Aging affects immune system activity. This study will look at some of the factors involved.     HIV also affects immune system activity. The results from this study, using healthy     volunteers, will be compared to those in another study of HIV-infected patients. This may     provide information on immune system activity in aging and HIV.   "
167067|NCT00014066|"     RATIONALE: Photodynamic therapy uses light and drugs that make cnacer cells more sensitive to     light to kill tumor cells. Brachytherapy uses radiation to damage tumor cells. Photodynamic     therapy combined with brachytherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy plus brachytherapy     in treating patients with recurrent lung cancer that is blocking the lung passages.   "
167068|NCT00014079|"     RATIONALE: Determination of genetic markers for colorectal cancer may improve the     identification of patients who are at highest risk for relapse.      PURPOSE: This clinical trial is studying the importance of genetic markers for detecting     relapse in patients with colorectal cancer.   "
167069|NCT00014092|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa     stimulate a person's white blood cells to kill cancer cells or may interfere with the growth     of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim,     interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that     cannot be treated with surgery.   "
167070|NCT00014105|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating     patients who have recurrent glioblastoma multiforme.   "
167071|NCT00014118|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer     of the larynx or stage III or stage IV cancer of the oropharynx.   "
167072|NCT00014131|"     RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body     build an immune response to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients     who have recurrent or stage III or stage IV kidney cancer.   "
167083|NCT00020930|"     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of cetuximab in treating patients who have     stage IV colorectal cancer that has not responded to previous treatment.   "
167084|NCT00020943|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and     either kill them or deliver tumor-killing substances to them without harming normal cells.     Peripheral stem cell transplantation may allow the doctor to give higher doses of     chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and rituximab     with peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.   "
167085|NCT00020969|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have myelodysplastic syndromes.   "
167086|NCT00020995|"     RATIONALE: A low-fat, high-fiber diet may slow the growth of prostate cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of a low-fat, high-fiber diet     with that of a standard diet in treating patients who have prostate cancer.   "
167087|NCT00021008|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ZD0473 in treating patients who have     progressive or relapsed non-small cell lung cancer.   "
167088|NCT00021021|"     RATIONALE: RPI.4610 may stop the growth of metastatic kidney cancer by stopping blood flow to     the tumor.      PURPOSE: Phase II trial to study the effectiveness of RPI.4610 in treating patients who have     metastatic kidney cancer.   "
167089|NCT00021034|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of taurolidine in treating patients who     have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal     cancer.   "
167090|NCT00021047|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin, carboplatin,     and capecitabine in treating patients who have unresectable locally advanced, metastatic, or     recurrent solid tumor.   "
167091|NCT00021060|"     Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they     stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy     with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is     to see if combination chemotherapy works better with or without bevacizumab in treating     patients who have advanced, metastatic, or recurrent non-small cell lung cance   "
167092|NCT00021073|"     Phase I trial to study the effectiveness of combining flavopiridol, fluorouracil, and     leucovorin with or without irinotecan in treating patients who have advanced cancer. Drugs     used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining more than one drug may kill more tumor cells.   "
167093|NCT00021099|"     Phase II trial to study the effectiveness of ixabepilone in treating patients who have     progressive or metastatic urinary tract cancer. Drugs used in chemotherapy use different ways     to stop tumor cells from dividing so they stop growing or die   "
167094|NCT00021112|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation     therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.   "
167095|NCT00021125|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known which regimen of radiation therapy is more effective for head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of     radiation therapy in treating patients who have head and neck cancer.   "
167096|NCT00021138|"     RATIONALE: Computer-assisted scheduling of nicotine inhaler use may be an effective method to     help people stop smoking.      PURPOSE: Randomized cinical trial to compare the effectiveness of computer-assisted     scheduling of nicotine inhaler use with that of self-scheduled nicotine inhaler use in     participants who plan to stop smoking.   "
167097|NCT00021151|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Compassionate use refers to     providing a drug to a patient on humanitarian grounds before the drug has received official     approval.      PURPOSE: Compassionate use of Campath-1H in treating patients who have refractory     prolymphocytic leukemia or chronic lymphocytic leukemia.   "
167098|NCT00021164|"     RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill     tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating     patients who have metastatic cancer.   "
167099|NCT00021216|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Phase I trial to study the effectiveness of bortezomib in treating children     who have advanced solid tumors that have not responded to previous treatment.   "
167100|NCT00021229|"     Phase I/II trial to estimate the maximum tolerated dose of imatinib mesylate in newly     diagnosed brain stem gliomas and recurrent high grade gliomas and to assess the effectiveness     of imatinib mesylate in treating young patients who have newly diagnosed intrinsic brain stem     glioma. Imatinib mesylate may interfere with the growth of tumor cells by blocking the     enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor     cells. Combining imatinib mesylate with radiation therapy may kill more tumor cells.   "
187278|NCT00288691|"     The aim of this study is to explore effects of the investigational product for the treatment     of treatment-resistant menorrhagia without organic cause.   "
167101|NCT00021242|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop     cancer cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children who have     relapsed or refractory acute lymphoblastic or acute myeloid leukemia.   "
167102|NCT00021255|"     Primary objective:        -  Compare disease-free survival in women with human epidermal growth factor receptor 2          (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer          treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without          trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin.      Secondary objective:        -  Compare overall survival of participants treated with these regimens.        -  Compare the toxic effects (including cardiac) of these regimens in these participants.        -  Compare quality of life of participants treated with these regimens.        -  Compare pathologic and molecular markers for predicting efficacy of these regimens in          these participants.        -  For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with          fluorescence in situ hybridization in predicting outcome in participants treated with          these regimens.   "
167103|NCT00021268|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of tocladesine in treating patients who     have recurrent or progressive metastatic colorectal cancer.   "
167104|NCT00021281|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. SU5416 may stop the growth of tumor cells by stopping blood flow to     the tumor. It is not yet known whether combination chemotherapy will be more effective with     or without SU5416 in treating metastatic colorectal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with or without SU5416 in treating patients who have metastatic colorectal cancer.   "
167105|NCT00024232|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have prostate cancer that has not responded to hormone therapy.   "
167106|NCT00024245|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Probenecid may increase the effectiveness of     10-propargyl-10-deazaaminopterin by making tumor cells more sensitive to the drug.      PURPOSE: Phase I trial to study the effectiveness of combining     10-propargyl-10-deazaaminopterin and probenecid in treating patients who have advanced solid     tumors.   "
167107|NCT00024258|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating children     who have advanced neuroblastoma or other solid tumors.   "
167108|NCT00024271|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving the drugs directly into the tumor after surgery and     combining them with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy, and     radiation therapy in treating patients who have peritoneal cancer.   "
167109|NCT00024284|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and irinotecan in     treating children who have refractory solid tumors.   "
167110|NCT00024297|"     RATIONALE: Warfarin may be effective in preventing the formation of blood clots in patients     with central venous catheters.      PURPOSE: Randomized clinical trial to study the effectiveness of warfarin in preventing blood     clots in cancer patients who have central venous catheters.   "
167111|NCT00024310|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Folic acid may protect normal cells from the side effects of     chemotherapy and may increase the effectiveness of chemotherapy by making tumor cells more     sensitive to the drug. Lometrexol may stop the growth of tumors by blocking one of the     enzymes necessary for cancer cell growth. Combining chemotherapy with folic acid and     lometrexol may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel, folic acid, and     lometrexol in treating patients who have locally advanced or metastatic solid tumors.   "
167112|NCT00024323|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining 3-AP with cisplatin in     treating patients who have advanced cancer.   "
167113|NCT00024336|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Tamoxifen may     kill tumor cells by blocking the enzymes necessary for cell growth. Combining radiation     therapy with tamoxifen may be effective in treating newly diagnosed brain stem glioma.      PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy and     tamoxifen in treating children who have newly diagnosed brain stem glioma.   "
167114|NCT00024349|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy such as fluorouracil and mitomycin use different ways to stop tumor cells from     dividing so they stop growing or die. Fluorouracil and mitomycin may make the tumor cells     more sensitive to radiation therapy. It is not yet known if radiation therapy is more     effective with or without chemotherapy in treating bladder cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to all     or part of the bladder with or without chemotherapy in treating patients who have stage II or     stage III bladder cancer.   "
167115|NCT00024362|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BBR 3464 in treating patients who have     locally advanced or metastatic pancreatic cancer that cannot be treated with surgery.   "
167116|NCT00024375|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who     have metastatic pancreatic cancer.   "
167117|NCT00024388|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who     have locally advanced, metastatic, or unresectable kidney cancer.   "
167118|NCT00024401|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who     have metastatic colorectal cancer.   "
167119|NCT00024414|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who     have metastatic prostate cancer that has not responded to hormone therapy.   "
167120|NCT00024427|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving the drugs in different combinations may kill more tumor     cells. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side     effects of chemotherapy. It is not yet known which chemotherapy regimen is more effective in     treating pancreatic cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus     triacetyluridine with that of gemcitabine in treating patients who have locally advanced or     metastatic pancreatic cancer that cannot be treated with surgery.   "
167121|NCT00024440|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Oblimersen may help fludarabine and cyclophosphamide kill more     cancer cells by making them more sensitive to the drugs. It is not yet known if fludarabine     and cyclophosphamide are more effective with or without oblimersen.      PURPOSE: Randomized phase III trial to compare the effectiveness of fludarabine and     cyclophosphamide with or without oblimersen in treating patients who have relapsed or     refractory chronic lymphocytic leukemia.   "
167122|NCT00024453|"     RATIONALE: Giving the antibiotic teicoplanin by infusion and allowing bacteria to be exposed     to the antibiotic for a longer period of time may be effective in preventing or controlling     septicemia.      PURPOSE: Randomized clinical trial to compare two different methods of giving teicoplanin in     treating septicemia in patients who are receiving chemotherapy through a central venous     catheter.   "
167123|NCT00024466|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Vaccines made from a person's cancer cells may make the body     build an immune response to kill cancer cells. Peripheral stem cell transplantation may be     able to replace immune cells that were destroyed by chemotherapy. Combining chemotherapy with     vaccine therapy and peripheral stem cell transplantation may be effective in treating     multiple myeloma.      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by vaccine     therapy and peripheral stem cell transplantation in treating patients who have newly     diagnosed multiple myeloma.   "
167124|NCT00024479|"     This study will explore the causes of rheumatic diseases and why many of them affect certain     minority communities more severely. Rheumatic diseases may cause joint pain, stiffness or     swelling. Some can involve bones, muscles, tendons or ligaments. Some cause abnormalities of     the immune system the body s defense against disease. Some rheumatic diseases are painful or     deforming and some can be life threatening. Information obtained from this study will be used     to learn about the disparities in rheumatic disease in the minority community and to design     further, more targeted, research studies to address this issue.      Patients with known or suspected rheumatic disease 18 years of age or older may be eligible     for this study. Candidates will undergo a medical history and physical examination to confirm     the diagnosis of rheumatic disease and determine what is needed for evaluation and treatment.      Participants will receive standard medical care for rheumatic disease and arthritis. No     experimental treatments, medications or procedures will be included in this study. Procedures     may include routine blood tests for blood chemistries, cell counts, and antibodies commonly     found in patients with rheumatic disease; a urine test for proteins and cells; and X-rays and     other imaging tests to check for abnormalities in the lungs or other organs. All medical     information will be kept confidential.      Patients who are found to be eligible for other current NIH research studies will be offered     an opportunity to participate in these studies.   "
167125|NCT00024492|"     Liposome entrapped mitoxantrone (LEM) is a mixture of commercially available mitoxantrone HCL     (Novantrone) and a combination of lyophilized lipids. Mitoxantrone, the active agent in the     investigational formulation, is a currently marketed chemotherapeutic agent. The rationale     for development of liposomal formulations is primarily that of improving the safety profile     of the drug, which may permit dose intensification and/or an increase in the cumulative dose     that may be administered, resulting in enhanced efficacy.      LEM will be given to patients with advanced solid tumors to determine the dose of drug these     patients can tolerate. Patients will receive intravenous LEM every 21 days until the disease     progresses or toxicity occurs requiring treatment discontinuation. Anti-tumor effects of LEM     will be assessed and patients will be evaluated for safety and tolerability.   "
167126|NCT00024505|"     The purpose of this study is to investigate the cardiac, clinical, and genetic aspects of     arrhythmogenic right ventricular dysplasia (ARVD), a progressive disorder that predominantly     affects the right side of the heart and causes ventricular arrhythmias.   "
167127|NCT00024518|"     This study will see if interferon-alpha given early in the disease can stop or slow the     immune attack on insulin-producing cells. In addition, the study will examine the safety and     efficacy of interferon-alpha (given by mouth) to protect beta cell function. Patients between     3 and 25 years of age with Type 1 Diabetes Mellitus less then six weeks may be eligible for     this study. All study-related tests and medications at the NIH Clinical Center are provided     at no cost.   "
167129|NCT00024544|"     The purpose of the study is to evaluate an investigational medication to treat chronic     asthma. The research is being conducted at 20 clinical research sites in the US and is open     to both men and women ages 18 to 70 years. Participants in the study will have a number of     visits to a research site over an 8-month period. All study-related care and medication is     provided to qualified participants at no cost. This includes all visits, examinations and     laboratory work.   "
174922|NCT00131287|"     The purpose of this study is to examine whether the extract of the Agaricus blazei Murill     mushroom is effective in the supplementary treatment of type II DM patients.   "
167130|NCT00024557|"     IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a     bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a     variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic     benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the     IL13 receptors was shown to be highly specific for human glioma cells.      Patients will receive IL13-PE38QQR via a catheter placed directly into the brain tumor. Tumor     recurrence will be confirmed by biopsy. The next day, patients will start a continuous     48-hour infusion of IL13-PE38QQR into the tumor. The dose (concentration) will be increased     in the pre-resection infusion until the endpoint is reached (histologic evidence of tumor     cytotoxicity or a maximum tolerated dose). Tumor resection will be planned for one week after     biopsy, plus or minus 1 day. A histologically-effective concentration (HEC) will be     determined using pathologic observations. At the end of resection, three catheters will be     placed in brain tissue next to the resection site and assessed within 24 hours using MRI. On     the second day after surgery, IL13-PE38QQR infusion will begin and will continue for 4 days.     The lowest pre-resection IL13-PE38QQR concentration will be used as the starting dose for     post-resection infusions. After an HEC or maximum tolerated dose (MTD) is determined, the     pre-resection infusion will no longer be administered. Subsequent patients will have tumor     resection and placement of three peri-tumoral catheters at study entry. IL13-PE38QQR will be     infused starting on the second day after surgery and continuing for 4 days. Escalation of the     post-resection IL13-PE38QQR concentration will be continued until the previously-defined HEC     or MTD is reached, after which duration of the post-resection infusion will be increased in     one day increments for up to 6 days. If a post-resection MTD is obtained, there will be no     increase in duration of infusion. In the final stage of the study, catheters will be placed 2     days after tumor resection, and a 4-day IL13-PE38QQR infusion will begin the day after     catheter placement. Patients will be observed clinically and radiographically for toxicity     and duration of tumor control.   "
167131|NCT00024570|"     IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a     bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a     variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic     benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the     IL13 receptors was shown to be highly specific for human glioma cells.      IL13-PE38QQR will be infused in two courses of 96 hours each, eight weeks apart, directly     into the malignant brain tumors of patients to determine the dose of drug these patients can     tolerate. After that, the selected dose will be studied to give an estimate of the response     rate, response duration, time to response, and survival after infusing that dose of     IL13-PE38QQR into the recurrent malignant glioma.   "
167132|NCT00024583|"     To determine whether maternal undernutrition in pregnancy is associated with differences     between siblings for cardiovascular risk factors in adulthood.   "
167133|NCT00024596|"     To determine familial and non-familial causes for susceptibility to atherosclerosis and the     inflammatory response.   "
167134|NCT00024622|"     This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and     blood flow in normal volunteers, persons with Parkinson s disease (both familial and     sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for     NIH approved protocol 89-M-0160, Inpatient Evaluation of Neuropsychiatric Patients, PI:     Daniel Eisenberg, M.D. Using PET with 6-[F-18] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a     single scan session, both presynaptic dopaminergic function and regional cerebral blood flow     (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in     striatum and other regions is calculated. We compare Ki across subject groups and relate the     findings to rCBF. Findings are also related to allelic variation in genes of interest, for     determination of which participants sign separate consent for NIH approved protocol 95-M-0150     Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their     Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited     vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both     groups, and we compare system-level, circuit-based pathophysiology across PD and     schizophrenia groups. Each subject is further screened with an MRI to rule out structural     abnormalities and also to further delineate areas of interest in the PET scans.   "
167135|NCT00024635|"     The purpose of this protocol is to allow for the careful screening of patients and healthy     volunteers for participation in research protocols in the Experimental Therapeutics and     Pathophysiology Lab (ETPB) at the National Institute of Mental Health (NIMH) and for the     collection of natural history data. In addition the protocol will allow clinicians to gain     more experience in the use of a variety of polysomnographic and high-density EEG recordings.     Subjects in this protocol will undergo an evaluation which may include: a psychiatric     interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain     magnetic resonance imaging (MRI); electroencephalography (EEG); electrocardiography (EKG),     magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request     for medical records. Subjects may also be asked to complete questionnaires about attitudes     towards research and motivation for research participation. The data collected may also be     linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA,     psychophysiology tests, treatment studies, etc) for the purposes of better understanding the     diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents     of minors will be interviewed. Upon conclusion of the screening process, subjects will either     be offered participation in a research protocol and will sign the appropriate informed     consent, or will be considered not appropriate for participation in research and will be     referred back into the community. The current protocol thus serves as an entry point for     individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved     ETPB protocols.   "
167156|NCT00025077|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving a chemotherapy drug before surgery or radiation therapy may     shrink the tumor so that it can be removed during surgery or radiation therapy. Peripheral     stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy     or radiation therapy and allow doctors to give higher doses of chemotherapy.      PURPOSE: This phase II trial is studying how well combination chemotherapy followed by     surgery or radiation therapy and peripheral stem cell transplant work in treating patients     with recurrent medulloblastoma or primitive neuroectodermal and pineal tumors.   "
167306|NCT00010114|"     RATIONALE: Genetic studies may help in understanding the genetic processes involved in the     development of some types of cancer.      PURPOSE: Genetic study to learn more about genes involved in the development of central     nervous system tumors in young children.   "
167161|NCT00025142|"     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor     cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Combining more than one drug with     gefitinib may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of gefitinib and oxaliplatin combined with     leucovorin and fluorouracil in treating patients who have advanced solid tumors or colorectal     cancer.   "
167136|NCT00024648|"     LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein     produced by human cells, both normal and cancerous, which may help protect tumor cells from     radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount     of a certain target protein by blocking the gene that makes it. Antisense oligonucleotide to     raf gene can reduce the amount of Raf-1 protein in tumor cells. Liposomes are tiny globules     of fat, which can carry drugs in the body. The experimental agent LErafAON is composed of     liposomes carrying antisense oligonucleotide against the Raf-1 protein. It is hoped that     decreased Raf-1 in the cancer cells will make them more sensitive to the radiation therapy.      Patients with advanced malignancies will receive daily IV infusions of LErafAON for 2 weeks     (total of 10 doses) during clinically indicated palliative radiotherapy. Cohorts of at least     three patients will be entered at escalating dose-levels. Each cohort will be observed for     toxicity for at least two weeks after completion of treatment with study medication before     the next cohort is enrolled. The study will be stopped when a maximum tolerated dose (MTD) is     identified. Dose escalation within a patient will not be allowed. Safety and supportive care     requirements will be assessed.   "
167137|NCT00024661|"     LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein     produced by human cells, both normal and cancerous, which may help protect tumor cells from     radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount     of a certain target protein by blocking the gene that makes it. Antisense oligonucleotide to     raf gene can reduce the amount of Raf-1 protein in tumor cells. Liposomes are tiny globules     of fat, which can carry drugs in the body. The experimental agent LErafAON is composed of     liposomes carrying antisense oligonucleotide against the Raf-1 protein. It is hoped that     decreased Raf-1 in the cancer cells will make them more sensitive to the radiation therapy.      Patients with advanced solid tumors will receive IV infusions of LErafAON over at least 60     minutes, once per week, for 8 weeks. In the absence of progression, patients may continue on     weekly treatment. Pre-medications will be administered prior to each dose of study     medication.      Cohorts of at least three patients will be entered at escalating dose-levels. Each cohort     will be observed for at least ten days after receiving the first dose of treatment before     additional patients are treated at a higher dose level. Patients will be followed for one     month after receiving the last dose of study medication. The study will stop when a maximum     tolerated dose (MTD) is identified. Dose escalation within a patient will not be allowed.   "
167138|NCT00024674|"     Although Neopharm has terminated its sponsorship of this study, it is continuing under the     sponsorship of the NCI. Please see Experimental Drug SS1(dsFv)-PE38 to Treat Cancer (Study     ID number 010011).      SS1(dsFv)-PE38 is an oncology drug product containing a bacteria toxin, fused to a high     affinity, disulfide stabilized antibody. The fused protein retains cell killing activity, but     binds only to cells expressing mesothelin. Tumors characterized by very high surface     mesothelin expression include mesothelioma; epithelial carcinomas of ovary and peritoneum;     and squamous cancers of cervix and upper aerodigestive tract, including esophagus, head, and     neck cancers.      This is a dose-escalating study to determine the maximum tolerated dose (MTD) of intravenous     SS1(dsFv)-PE38 administered continuously for 10 days every four weeks for a maximum of four     courses of treatment. Dose escalation will proceed in cohorts of 3 until dose-limiting     toxicity (DLT) is observed.   "
167139|NCT00024687|"     Although Neopharm has terminated its sponsorship of this study, it is continuing under the     sponsorship of the NCI. Please contact Raffit Hassan, MD at 301-451-8742 for more     information. Also see the related NCI study Experimental Drug SS1(dsFv)-PE38 to Treat     Cancer (Study ID number 010011).      SS1(dsFv)-PE38 is an oncology drug product containing a bacteria toxin, fused to a high     affinity, disulfide stabilized antibody. The fused protein retains cell killing activity, but     binds only to cells expressing mesothelin. Tumors characterized by very high surface     mesothelin expression include mesothelioma; epithelial carcinomas of ovary and peritoneum;     and squamous cancers of cervix and upper aerodigestive tract, including esophagus, head, and     neck cancers.      This is a dose-escalating study to determine the maximum tolerated dose (MTD) of intravenous     SS1(dsFv)-PE38 administered once every other day for six doses. Dose escalation will proceed     in cohorts of 3 until dose-limiting toxicity (DLT) is observed.   "
167140|NCT00024791|"     This study will examine how the brain controls eye-hand coordination (visuomotor skills) in     children with spastic diplegia and will determine whether impairment of this skill is related     to the learning difficulties in school that some of these children experience. Spastic     diplegia is a form of cerebral palsy that affects the legs more than the hands. The brain     injury causing the leg problem in this disease may also cause difficulty with eye-hand     coordination.      Healthy normal volunteers and children with spastic diplegia between 6 and 12 years of age     may be eligible for this study. Candidates will be screened with a review of medical and     school records, psychological testing, neurological and physical examinations, and assessment     of muscle function in the arms and legs.      Participants may undergo one or more of the following procedures:      Neuropsychological testing (1 to 2 hours) - involves sitting at a computer and answering     questions, such as whether the letters on the screen make up a real word.      Magnetic resonance imaging (MRI) (45 minutes) - uses a strong magnetic field and radio waves     to provide images of the brain. The child lies on a table in a narrow cylindrical machine     while the scans are obtained. Both the child and parent wear earplugs to muffle the loud     noise the radio waves make while the images are formed.      Electroencephalography (EEG) and electromyography (EMG) (1 to 2 hours) - EEG uses electrodes     to record the electrical activity of the brain. The electrodes are in a special cap that is     worn on the head during the procedure. EMG records electrical activity from muscles.     Electrodes are placed on the skin over certain muscles. During the test, the child makes     simple repetitive movements, such as finger tapping. The cap and the electrodes on the skin     are removed at the end of the test.   "
167157|NCT00025090|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet     known if fluorouracil plus radiation therapy is more effective with or without additional     chemotherapy in treating anal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus     radiation therapy with or without additional chemotherapy in treating patients who have     primary anal cancer.   "
167141|NCT00024804|"     This study has four objectives: 1) to provide investigators the opportunity to study bone     specimens from patients with various skeletal diseases; 2) to treat patients with skeletal     diseases at the NIH; 3) to expose NIH trainees to certain skeletal diseases; and 4) to gain     more knowledge about skeletal diseases and stimulate further study of bone biology.      Anyone with a disease that affects the skeleton may be eligible for this study.      All evaluations, tests, procedures and treatments given study participants are used in the     standard care of skeletal diseases. No experimental evaluations or treatments are offered.     Patient evaluations include a medical history, review of medical records and routine physical     examination. Based on the findings, other procedures may be recommended, including blood     tests, urine tests, and imaging tests, such as X-rays, bone densitometry, bone scan, computed     tomography (CT) and magnetic resonance imaging (MRI).      Bone specimens from participants will be collected for research use. Specimens will be     obtained from bone removed during a patient s planned surgical procedure performed for     medical care, or patients may be requested to have a bone biopsy removal of a small piece of     bone tissue as part of the patient evaluation procedure.   "
167142|NCT00024817|"     To characterize the pattern of change over a two year period in energy expenditure and energy     intake in two cohorts of American Indian (AI) children.   "
167143|NCT00024830|"     To evaluate the efficacy of peer-based skills training to enhance weight control and improve     psychosocial functioning in overweight adolescents.   "
167144|NCT00024843|"     To assess the efficacy of a 2-year family-based weight prevention program in a cohort of     overweight preschool children and overweight parent pairs.   "
167145|NCT00024908|"     This study will examine the underlying mental processes that determine how people understand     social behavior, remember information, and think. Language, planning, problem solving,     reasoning, social behavior, and memory are the critical parts of cognition that make up daily     life. This study will explore the association between performance on various experimental     tasks and day-to-day functioning.      Healthy normal volunteers and patients with certain kinds of brain damage (primarily focal or     degenerative lesions of the human prefrontal cortex) or psychiatric disorders may be eligible     for this study. Candidates with central nervous system trauma, disease or dysfunction will be     screened with a routine neurological examination and history.      Participants may be asked to complete written tests, sit in front of a computer monitor and     press a key to indicate a decision about what appears on the screen (for example, whether a     statement is accurate) and answer questions from a test examiner. A skin conductance response     (SCR) test may be done along with some of the cognitive tests. SCR uses electrodes (pieces of     metal attached to wires) placed on the fingers to measure the subject's emotional reaction to     a test. Participants may also do an evoked response test, in which the subject watches words     or scenes on a TV screen while his or her responses are recorded from electrodes placed on     the scalp (similar to an electroencephalogram). The tests will be scheduled for an average of     one session a week, with each session lasting from 30 minutes to 3 hours. Generally, 15     sessions will be scheduled over a 1-year period. Special arrangements will be made to     accommodate participants from out-of-town.      Participants may have a magnetic resonance imaging (MRI) scan of the brain. This test uses     radio waves and a strong magnetic field to picture structural and chemical changes in tissue.     For the procedure, the subject lies on a table in a space enclosed by a metal cylinder (the     scanner) for about 1 hour.      In addition, some study subjects will be invited to participate in a training study designed     to improve their planning or social behavior. Participation requires coming to NIH daily over     a 1- to 2-month period for 1 to 2 hours each visit.   "
167146|NCT00024921|"     Kidney disease in diabetes (diabetic nephropathy) tends to run in families. It is likely,     therefore, that there are genes that predict or are associated with either getting or not     getting diabetic nephropathy. The GoKinD Study will provide clinical information and DNA for     investigators to look for these genes. Evaluation will be performed and DNA obtained from     approximately 1100 diabetic persons with kidney disease and 1000 diabetic persons without     kidney disease. In some cases, samples for DNA will also be obtained from the parents of     these subjects. Clinical information and DNA will be coded so that individuals cannot be     identified, but the DNA can be linked to the clinical data from the individual. Multiple     investigators will be able to use this genetic material to test hypotheses about the genetics     of kidney disease in diabetes.   "
167147|NCT00024934|"     This study will examine the safety of BlyS, an experimental drug being developed to treat     immune deficiency. As of July 17, 2001, 7 persons with common variable immune deficiency     (CVID) have received BlyS, with no problems reported. This study will test the safety of the     drug in people with IgA deficiency.      Patients 18 years of age and older with IgA deficiency who have recurrent or chronic sinus or     lung infections or chronic diarrhea or malabsorption may be eligible for this study.     Candidates will be screened with a physical examination, blood and urine tests,     electrocardiogram (EKG), chest X-ray and a breathing test (spirometry).      Participants will be divided into five groups of three persons each to receive different     doses (0.1, 1, 5, 15 or 45 micrograms/kilogram of body weight) of BlyS. The first group will     receive a single dose at the lowest dose level (0.l mg). Each succeeding group will receive a     single higher dose following a 2-week observation period of the preceding group. The drug     will be injected under the skin, with vital signs (temperature, pulse, blood pressure and     breathing rate) monitored for one hour after dosing. Blood samples will be collected several     times on the day of dosing (before the dose and at 1.5, 3, 5, 8 and 12 hours after the dose)     and again at 1,2, 4, 8 and 12 weeks after the dose to measure BlyS levels and evaluate     safety. Participants receiving one of the three higher doses will have additional blood     samples collected 36, 48 and 60 hours after the dose. Blood will also be collected from all     participants 6 and 12 months after dosing to look for any unexpected long-term effects. A     total of 289 ml (1.2 cups) of blood will be collected.      Blood will be checked for changes in blood count, kidney and liver function, antibody levels     and autoimmune problems. Saliva will be collected four times by placing a cotton ball in the     mouth-once before the dose and three times after the dose-to measure antibody levels.      Urine samples will also be collected during the study.   "
167158|NCT00025103|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may     allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: This phase II trial is studying how well chemotherapy followed by surgery and     radiation therapy with or without stem cell transplant work in treating patients with     relapsed or refractory Wilms' tumor or clear cell sarcoma of the kidney.   "
167159|NCT00025116|"     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells     and slow the growth of prostate cancer. It is not yet known which dose of ZD 1839 is more     effective in treating prostate cancer that has not responded to hormone therapy.      PURPOSE: Randomized phase II trial to compare different doses of ZD 1839 in treating patients     who have prostate cancer that has not responded to hormone therapy.   "
167160|NCT00025129|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have     advanced solid tumors or lymphomas.   "
167307|NCT00010127|"     RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune     response to kill prostate tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have metastatic prostate cancer.   "
167148|NCT00024960|"     This study will use positron emission tomography (PET) to examine the role of the chemical     messenger dopamine in stuttering. It will measure and compare the number of dopamine     receptors and the amount of dopamine released in the brains of stutterers with that of normal     volunteers. The results may provide information about how drugs that block dopamine's effect     might work to enable fluent speech.      Healthy normal volunteers and people with developmental stuttering between the ages of 18 and     55 may be eligible for this study. Candidates will be screened with a medical history and     possibly a physical examination and laboratory tests.      Participants will have a hearing test and cognitive function tests to measure speech,     language, memory and visual skills. In addition, they will undergo the following procedures:        -  PET scanning to measure brain blood flow and dopamine distribution in the brain. PET          uses radioactive materials to show cellular activity in specific tissues of the body.          Before starting the procedure, a thin plastic tube (intravenous, or IV line) is placed          in a vein in each arm of the subject and a special plastic mask is molded to the face.          (The mask is used to insure that the position of the head does not change during the          scan.) For the scan, the subject lies on a bed that is positioned into the scanner. A          preliminary transmission scan is done to make necessary measurements and adjustments.          Following this scan, 10 injections of radioactive water are given through an IV line.          During these injections, the subject performs a series of speech tasks-such as singing,          telling a story, or reciting nursery rhymes-that will elicit either fluent speech or          stuttering. A special camera detects the radiation emitted and produces images of brain          blood flow during stuttering and normal speech. Next, raclopride (a radioactive material          that attaches to dopamine receptors on the cell surface) is given through an IV line and          more pictures of the brain are taken. Fifty minutes after the raclopride injection,          amphetamine-a drug that increases brain dopamine levels-is injected through the other IV          line and more pictures are taken to show dopamine distribution in the brain. Fifty          minutes after the amphetamine infusion, the IV lines are removed.        -  Magnetic resonance imaging (MRI) of the brain to complement and interpret information          from the PET scans. MRI uses a strong magnetic field and radio waves to show structural          changes in tissues. The subject lies on a table surrounded by a metal cylinder (the          scanner). During the procedure, which may take from 20 minutes to 2 hours, subjects may          be asked to perform simple tasks, such as speaking or moving their arms. They can speak          with a staff member via an intercom at all times during the procedure and can be moved          out of the machine any time they request.      Participants may be asked to return for up to two scanning sessions within a year. For these     scans, only 1 injection of radioactive water will be given.   "
167149|NCT00024986|"     This study will test the safety, side effects and antiviral activity of different doses of     tenofovir DF in children and adolescents with human immunodeficiency virus (HIV) infection.     Tenofovir DF belongs to a group of drugs called nucleotide analog reverse transcriptase     inhibitors. These drugs prevent the virus from replicating (making more copies of itself).      HIV becomes resistant to many drugs used to fight the virus and these drugs become     ineffective. In laboratory tests, tenofovir DF has remained effective against HIV longer than     other anti-HIV medicines, and when resistance does develop, the virus may still be sensitive     to other drugs.      HIV-infected children between the ages of 4 and 18 years who weigh at least 10 kg (22 pounds)     may be eligible for this study. They must be able to receive antiretroviral therapy and have     completed at least two previous antiretroviral courses of treatment without benefit.      Upon entering the study, participants will have physical, eye and neuropsychiatric     examinations, blood tests, including tests to determine what anti-HIV drugs the patient is     resistant to, an echocardiogram (echo), electrocardiogram (EKG), chest X-ray, head CT scan,     skin tests, and special tests to examine the bones. These physical exams and tests will be     repeated throughout the study to determine changes in health.      Participants will continue their current anti-HIV therapy for 2 weeks and then stop all     medicines for a 1-week 'washout' period. After the washout period, patients will begin taking     tenofovir DF. For the first 2 days on the drug, a small blood sample (1/2 teaspoon) will be     collected 11 times over a 48-hour period through. A heparin lock (a tube kept in place in a     vein) may be put in place to avoid multiple needle sticks. Blood samples will be collected     for another 4 days to measure how well tenofovir DF alone works against HIV before other     drugs are added to the treatment regimen. After these first 6 days, at least two other     anti-HIV drugs will be added. They will be selected based on the results of the earlier blood     tests for resistance and on the child's medication history.      After 3 days of combination therapy, patients will continue therapy on an outpatient basis.     They will be seen in the clinic every 4 weeks at the start of the study and then every 12     weeks for physical exams, lab tests and other procedures as needed. The study will last     approximately 48 weeks. Patients who benefit from therapy may be able to continue to receive     tenofovir DF from the drug company sponsor or as part of another study, or the protocol for     this study may be amended to lengthen the treatment period.   "
167150|NCT00024999|"     This study will examine how the brain operates during execution and control of voluntary     movement and what goes wrong with these processes in disease. It will use     electroencephalography (EEG) and electromyography (EMG) to compare brain function in normal     subjects and in patients with-a disorder affecting patients with stroke and other brain     lesions. These patients have problems with timing, sequence and spatial organization of     certain types of movements.      EEG measures the electrical activity of the brain. The activity is recorded using wire     electrodes attached to the scalp or mounted on a Lycra cap placed on the head. EMG measures     electrical activity from muscles. It uses wire electrodes placed on the skin over the     muscles.      Adult healthy normal volunteers and patients with ideomotor apraxia with a single left brain     lesion may be eligible for this study.      Study participants will be asked to make certain movements with their arms or hands, such as     waving and using scissors. Brain and muscle activity will be measured during these tasks with     EEG and EMG recordings. Patients may be asked to repeat these tests over time as their     condition changes (such as during recovery from a stroke) to gain information about the     recovery process.   "
167151|NCT00025012|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Isotretinoin may be effective in preventing the     development or recurrence of skin cancer.      PURPOSE: Clinical trial to study the effectiveness of isotretinoin in preventing or slowing     the growth of skin cancer in patients who have xeroderma pigmentosum or basal cell carcinoma.   "
167152|NCT00025025|"     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective     treatment for colorectal cancer.      PURPOSE: Randomized screening trial to compare the effectiveness of fecal occult blood     testing with that of DNA-based testing of stool and blood in identifying colorectal cancer.   "
167153|NCT00025038|"     Giving chemotherapy drugs, such as R115777, isotretinoin, cytarabine, and fludarabine, before     a donor bone marrow transplant or an umbilical cord transplant helps stop the growth of     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem     cells. When the healthy stem cells from a donor are infused into the patient they may help     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     This phase II trial is studying how well giving combination chemotherapy together with donor     bone marrow or umbilical cord blood transplant works in treating children with newly     diagnosed juvenile myelomonocytic leukemia   "
167154|NCT00025051|"     RATIONALE: Celecoxib may be effective in preventing skin cancer by decreasing redness caused     by exposure to ultraviolet light and changing potential skin cancer biomarkers. It is not yet     known whether celecoxib is more effective than a placebo in preventing skin cancer.      PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing skin     cancer in participants exposed to ultraviolet light.   "
167155|NCT00025064|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Peripheral stem cell transplant may be able to replace immune cells that were destroyed by     chemotherapy.      PURPOSE: This phase II trial is studying how well combination chemotherapy regimens with or     without radiation therapy or peripheral stem cell transplant works in treating children with     Hodgkin's lymphoma.   "
167162|NCT00025155|"     Phase II trial to study the effectiveness of ixabepilone in treating patients who have     recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not     responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop     tumor cells from dividing so they stop growing or die.   "
167163|NCT00025168|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different     ways to stop tumor cells from dividing so they stop growing or die. Combining radiation     therapy with chemotherapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation     therapy in treating patients who have locally advanced, unresectable pancreatic cancer.   "
167164|NCT00025181|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Vaccines made from a person's     cancer cells may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining monoclonal antibody therapy     and vaccine therapy in treating patients who have stage III or stage IV melanoma that has     been removed during surgery.   "
167165|NCT00025194|"     RATIONALE: Drugs used in chemotherapy, such as ixabepilone and estramustine, use different     ways to stop tumor cells from dividing so they stop growing or die. It is not yet known     whether BMS-247550 is more effective with or without estramustine in treating prostate     cancer.      PURPOSE: This randomized phase I/II trial is studying the best dose of ixabepilone when given     together with estramustine and to see how well giving ixabepilone together with estramustine     works compared to ixabepilone alone in treating patients with progressive prostate cancer.   "
167166|NCT00025207|"     Phase II trial to study the effectiveness of gefitinib in treating patients who have     malignant mesothelioma. Biological therapies such as gefitinib may interfere with the growth     of the tumor cells and slow the growth of malignant mesothelioma   "
167167|NCT00025220|"     Phase II trial to study the effectiveness of thalidomide in treating patients who have     recurrent or persistent cancer of the uterus. Thalidomide may stop the growth of cancer by     stopping blood flow to the tumor.   "
167168|NCT00025233|"     This phase II trial is to see if bevacizumab works in treating patients who have persistent     or recurrent cancer of the cervix. Monoclonal antibodies, such as bevacizumab, can block     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.     Others find cancer cells and help kill them or deliver cancer-killing substances to them.   "
167169|NCT00025246|"     This phase II trial is studying how well imatinib mesylate works in treating patients with     gastrointestinal stromal tumor that was completely removed during surgery. Imatinib mesylate     may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth   "
167170|NCT00025259|"     This randomized phase III trial is studying different chemotherapy regimens given with or     without radiation therapy to compare how well they work in treating children with newly     diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer     cells from dividing so they stop growing or die. Giving the drugs in different combinations     may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells.     It is not yet known if chemotherapy is more effective with or without additional chemotherapy     and/or radiation therapy in treating Hodgkin's disease.   "
167171|NCT00025272|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving them in different ways may     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining topotecan, carboplatin, and     etoposide in treating patients who have extensive-stage small cell lung cancer.   "
167172|NCT00025285|"     RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.     Combining thalidomide with chemotherapy may kill more tumor cells and be an effective     treatment for stage IIIB or stage IV non-small cell lung cancer.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     thalidomide in treating patients who have stage IIIB or stage IV non-small cell lung cancer.   "
167173|NCT00025298|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining radiation therapy with chemotherapy may kill more tumor cells. Giving     chemoprotective drugs such as amifostine may protect normal cells from the side effects of     chemotherapy and radiation therapy.      PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel and carboplatin     followed by cisplatin plus radiation therapy with or without amifostine in treating patients     who have locally advanced cancer of the nasopharynx.   "
167174|NCT00025311|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular     topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the     lining around the brain.   "
167175|NCT00025324|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.     Radiation therapy uses high-energy x-rays to damage tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, surgery, radiation     therapy, and bone marrow or peripheral stem cell transplantation in treating patients who     have primary CNS germ cell tumors.   "
167191|NCT00025532|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver     tumor-killing substances to them without harming normal cells. This may be an effective     treatment for gastrointestinal cancer.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy     in treating patients who have gastrointestinal cancer.   "
167192|NCT00025545|"     RATIONALE: Transplanted peripheral stem cells can sometimes be rejected by the body's     tissues. Treating donor peripheral stem cells with filgrastim may increase the number of     donor white blood cells. This may help to decrease the rejection of the transplanted cells in     patients receiving them as treatment for acute leukemia.      PURPOSE: Phase II trial to study the effectiveness of filgrastim-treated donor peripheral     stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell     transplantation.   "
167176|NCT00025337|"     Randomized phase III trial to compare the effectiveness of combination chemotherapy with or     without bevacizumab in treating patients who have advanced or metastatic colorectal cancer     that has been previously treated. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab     can locate tumor cells and either kill them or deliver tumor-killing substances to them     without harming normal cells. Combining monoclonal antibody therapy with combination     chemotherapy may kill more tumor cells. It is not yet known if bevacizumab is more effective     with or without combination chemotherapy in treating colorectal cancer   "
167177|NCT00025350|"     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor     cells and slow the growth of recurrent metastatic colorectal cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of     gefitinib in treating patients who have recurrent metastatic colorectal cancer.   "
167178|NCT00025363|"     Randomized phase II trial to compare the effectiveness of different combination chemotherapy     regimens in treating children who have rhabdomyosarcoma. Drugs used in chemotherapy work in     different ways to stop tumor cells from dividing so they stop growing or die. Combining more     than one drug may kill more tumor cells   "
167179|NCT00025376|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which regimen of PS-341 is more effective in     treating metastatic kidney cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients     who have metastatic kidney cancer.   "
167180|NCT00025389|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work     in different ways to stop tumor cells from dividing so they stop growing or die. Combining     monoclonal antibody therapy with chemotherapy before surgery may may shrink the tumor so that     it can be removed.      PURPOSE: This phase II trial is to see if bevacizumab, paclitaxel, and carboplatin given     before surgery work in treating patients who have stage IB, stage II, or stage IIIA non-small     cell lung cancer.   "
167181|NCT00025402|"     RATIONALE: Giving chemotherapy, such as hydroxyurea, cytarabine, idarubicin, and etoposide     before a donor bone marrow transplant or stem cell transplant helps stop the growth of cancer     cells. It also helps stop the patient's immune system from rejecting the donor's stem cells.     Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer.     When the healthy stem cells from a donor are infused into the patient they may help the     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It     is not yet known whether chemotherapy is more effective with or without interferon alfa     and/or bone marrow or stem cell transplant in treating patients with chronic myelogenous     leukemia.      PURPOSE: This randomized phase III trial is studying chemotherapy and biological therapy to     see how well it works compared with chemotherapy, biological therapy, and donor bone marrow     transplant or autologous stem cell transplant in treating patients with chronic phase chronic     myelogenous leukemia.   "
167182|NCT00025415|"     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Phase I trial to study the effectiveness of imatinib mesylate in treating     patients who have advanced cancer and liver dysfunction   "
167183|NCT00025428|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so     that it can be removed during surgery.      PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy given     before surgery in treating children who have localized neuroblastoma.   "
167184|NCT00025441|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors.   "
167185|NCT00025454|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have     advanced solid tumors.   "
167186|NCT00025467|"     Phase II trial to study the effectiveness of thalidomide in treating patients who have     recurrent or persistent endometrial cancer. Thalidomide may stop the growth of cancer by     stopping blood flow to the tumor   "
167187|NCT00025480|"     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by making tumor cells more sensitive to radiation therapy.     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells     either by killing the cells or by stopping them from dividing and may also make tumor cells     more sensitive to radiation therapy.      PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when     given together with radiation therapy after combination chemotherapy in treating patients     with stage III non-small cell lung cancer.   "
167188|NCT00025493|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating older women who     have metastatic breast cancer.   "
167189|NCT00025506|"     This phase II trial is studying how well thalidomide works in treating patients with     carcinosarcoma of the uterus that has come back or that does not go to remission (decrease or     disappear but may still be in the body) despite treatment. Thalidomide may stop the growth of     cancer by stopping blood flow to the tumor.   "
167190|NCT00025519|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy and radiation therapy used to kill cancer cells. Sometimes the     transplanted cells can be rejected by the body's tissues. Mycophenolate mofetil, tacrolimus,     and donor white blood cells may prevent this from happening.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral     stem cell transplantation in treating patients who have metastatic or recurrent kidney     cancer.   "
167193|NCT00025558|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining temozolomide, thiotepa, and     carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation     in treating patients who have brain cancer.   "
167194|NCT00025571|"     RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to     light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells     and, when exposed to light, become active and kill the tumor cells.      PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in     treating patients who have non-small cell lung cancer.   "
167195|NCT00025584|"     PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell     growth. Phase II trial to study the effectiveness of PS-341 in treating women who have     metastatic breast cancer   "
167196|NCT00025597|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so     that it can be removed during surgery.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     surgery in treating infants who have newly diagnosed neuroblastoma.   "
167197|NCT00025610|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of different combination chemotherapy     regimens in treating infants who have newly diagnosed neuroblastoma.   "
167198|NCT00025623|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug, and giving them before surgery, may     shrink the tumor so that it can be removed during surgery.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     surgery in treating infants who have newly diagnosed neuroblastoma.   "
167199|NCT00025636|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give     higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which     combination chemotherapy regimen given before peripheral stem cell transplant is more     effective in treating relapsed Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is comparing different regimens of combination     chemotherapy followed by peripheral stem cell transplant to see how well they work in     treating patients with relapsed Hodgkin's lymphoma.   "
167200|NCT00025649|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow     transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy given before     surgery followed by peripheral stem cell or bone marrow transplantation in treating infants     who have newly diagnosed neuroblastoma.   "
167201|NCT00025662|"     This study will evaluate the safety and effectiveness of stem cell transplantation in which     the donors T lymphocytes have undergone selective depletion. Certain patients with cancers     of the blood undergo transplantation of donated stem cells to generate new and normally     functioning bone marrow. In addition to producing the new bone marrow, the donor's     T-lymphocytes also fight any tumor cells that might have remained in the body. This attack on     tumor cells is called a graft-versus-leukemia (GVL) effect. However, another type of     T-lymphocyte from the donor may cause what is called graft-versus-host-disease (GVHD), in     which the donor cells recognize the patient's cells as foreign and mount an immune response     to reject them. Selective depletion is a technique that was developed to remove the     T-lymphocytes that cause harmful GVHD, while keeping those that produce the desirable GVL     effect.   "
167202|NCT00025675|"     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor     cells and slow the growth of CNS tumors.      PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have     recurrent or progressive CNS tumors.   "
167203|NCT00025688|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if paclitaxel is more effective with or without     carboplatin in treating stage IV breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or     without carboplatin in treating women who have stage IV breast cancer.   "
167204|NCT00025701|"     This study will examine how the brain operates during execution and control of voluntary     movement and what goes wrong with these processes in disease. It will use     electroencephalography (EEG) and electromyography (EMG) to compare brain function in normal     subjects and in patients with focal hand dystonia. In dystonia, involuntary muscle movements,     or spasms, cause uncontrolled twisting and repetitive movement or abnormal postures. Focal     dystonia involves just one region of the body, such as the hand, neck or face.      EEG measures the electrical activity of the brain. The activity is recorded using wire     electrodes attached to the scalp or mounted on a Lycra cap placed on the head. EMG measures     electrical activity from muscles. It uses wire electrodes placed on the skin over the     muscles.      Adult healthy normal volunteers and patients with focal hand dystonia may be eligible for     this study. Patients will be selected from NINDS's dystonia patient database.      Participants will sit in a semi-reclining chair in a darkened room and be asked to move     either their right index finger, right foot, or the angle of their mouth on the right side at     a rate of one movement every 10 seconds. Brain and muscle activity will be measured during     this task with EEG and EMG recordings.   "
167246|NCT00026273|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving them after surgery may kill     more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and     leucovorin with or without irinotecan in treating patients who have undergone surgery for     stage III colorectal cancer.   "
168441|NCT00033007|"     The purpose of this study is to test the utilization of incentive values (considerably lower     than those typically used in research clinics) to motivate clients to attend treatment and     initiate and sustain abstinence.   "
167205|NCT00025714|"     This study will collect brain tissue samples for research purposes from patients undergoing     surgery to treat epilepsy. The standard surgical procedure for medically intractable epilepsy     i.e., epilepsy that cannot be controlled with medicine requires removal of more brain tissue     than is needed for diagnostic study. This extra tissue, which would otherwise be discarded,     will be used for research purposes. In addition, a blood vessel in the scalp, called the     superficial temporal artery, is also normally cut during surgery, and a piece of this vessel     will be taken for research use.      Patients 4 years of age or older who undergo surgery for medically intractable epilepsy may     be eligible for this study.      Brain tissue collected under this protocol will be used for studies of brain cells in other     diseases and of serotonin receptors. Any remaining brain tissue will be frozen for use in     future research. The superficial temporal artery will be used for comparison with carotid     arteries (a neck artery that supplies the brain) from patients with blockage of this blood     vessel.   "
167206|NCT00025727|"     The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV)     versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors     (RTIs), in patients who have taken anti-HIV drugs without success.   "
167207|NCT00025740|"     Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that follows exposure to an     extremely traumatic stressors. PTSD is associated with serious symptoms. While numerous     approaches have been used to treat PTSD, these treatments have several limiting factors. This     study will evaluate a combination of the drugs clonazepam and paroxetine for the treatment of     PTSD symptoms.      The main goal of treatment in patients with PTSD is to significantly reduce symptom severity     and improve functioning. While numerous approaches have been used to treat PTSD, these     treatments are limited by variable response rates, up to a 6-week lag period before clinical     response, and sub-optimal side effect profile, including possible worsening of anxiety and     insomnia prior to clinical response. The proposed study will examine whether combined     treatment with a benzodiazepine (clonazepam) and a selective serotonin reuptake inhibitor     (paroxetine) in patients with PTSD will accelerate the onset of clinical response. A second     goal is to evaluate whether the rapid and clinically meaningful benefits are sustained until     the end of the study, despite tapering off the benzodiazepine at the midpoint of the study.     The safety and tolerability of a combination of paroxetine and clonazepam will be compared to     paroxetine and placebo (an inactive pill) in the treatment of PTSD.      Participants in this study will be randomly assigned to receive either paroxetine plus     clonazepam or paroxetine plus a placebo for 12 weeks. Participants will have weekly clinic     visits for the first 4 weeks of the study and every other week for the last 8 weeks. Symptoms     of PTSD, anxiety, and depression will be evaluated and drug side effects will be noted during     the follow-up visits.   "
167208|NCT00025753|"     Several complications have become prevalent in people living with HIV/AIDS, including     increased blood sugar, increased blood fats and cholesterol, and fat tissue redistribution.     The causes of these complications are not well understood and effective treatments have not     been identified. We propose to test the efficacy and safety of 2 treatments for these     complications in people living with HIV/AIDS: aerobic, weight lifting exercise training, and     a new insulin-sensitizing agent called rosiglitazone (Avandia). Exercise and rosiglitazone     have been effective and moderately safe when used in HIV-seronegative people with diabetes,     but a specific trial is needed to test efficacy and safety in people living with HIV/AIDS.   "
167209|NCT00025766|"     The purpose of this study is to evaluate arterial patency and left ventricular ejection     fraction by examining angiographic data one year following a heart attack and treatment with     late revascularization.   "
167210|NCT00025779|"     This study will evaluate the efficacy and safety of methylphenidate for treating     hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with     Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and     Drug Administration for the treatment of children and adolescents with Attention Deficit     Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD     symptoms in PDD are limited. Children and adolescents who do not show a positive response to     methylphenidate will be invited to participate in a pilot study of the non-stimulant     medication guanfacine (Tenex).   "
167211|NCT00025792|"     The purpose of this study is to examine the safety and effectiveness of the drug pramipexole     given in combination with lithium or divalproex for the short-term treatment of acute     depression in patients with bipolar disorder.      Bipolar disorder is a severe, chronic, and often life-threatening illness. Treatments for     acute unipolar depression have been extensively researched. However, despite the availability     of a wide range of antidepressant drugs, a significant proportion of depressed patients fail     to respond to first-line antidepressant treatment. Novel and improved therapeutics for     bipolar depression are needed. This study will evaluate the antidepressant properties of     pramipexole.      This study will be conducted in three phases. Phase 1 is a 14-day washout period in which     participants will be tapered off all their psychiatric medicines except divalproex or     lithium. Participants will also be asked to adhere to a low caffeine and low monoamine diet.     During Phase 2, participants will be randomly assigned to receive either pramipexole or     placebo (an inactive pill) for 6 weeks. Participants who respond to treatment will be given     either open-label pramipexole or another clinical treatment.      Participants will be screened with a medical history, physical examination, electrocardiogram     (EKG), blood and urine tests, and a psychiatric evaluation. Women of childbearing potential     will have a pregnancy test. Participants will have a physical exam and EKG at study entry and     study completion. Blood will be drawn at various times throughout the study. Pulse and blood     pressure measurements will be taken daily. Weekly interviews will be conducted. Participants     and a control group of healthy volunteers will undergo positron emission tomography (PET) and     magnetic resonance imaging (MRI) scans of the brain.   "
167222|NCT00025935|"     This study seeks to learn more about the symptoms of severe mood dysregulation in children     and adolescents ages 7-17. Children and adolescents with severe mood dysregulation (SMD)     display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia,     distractibility, hyperactivity) and extreme responses to frustration (such as frequent,     severe temper tantrums). Researchers will describe the moods and behaviors of children with     these symptoms and use specialized testing and brain imaging to learn about the brain changes     associated with this disorder.   "
167212|NCT00025805|"     This study will examine the effectiveness of G-CSF in treating patients with Crohn's     disease-a long-term recurring inflammation of the small and large intestine. Patients may     have swelling and bleeding of the intestinal lining, which can lead to infection and     abdominal pain, weight loss, fever, diarrhea, bloody stools, fistula (connections between the     skin and intestine), intestinal blockages, and abscesses. Although there are various     treatments for Crohn's disease, many patients continue to have inflammation that is difficult     to control or severe side effects from the medications. G-CSF is an approved drug that is     used to increase white blood cell counts. Other cells, immune cells, exposed to G-CSF can     develop a specific immune action-a Th-2 response-that decreases the inflammatory response in     Crohn's disease-a Th-1 response.      Patients 18 years of age or older who have had mild to moderately severe Crohn's disease for     at least 4 months may be eligible for this study. Candidates will be screened with a medical     history and possible review of medical records, physical examination, blood tests,     electrocardiogram (EKG), urine and stool analyses and, for women, a pregnancy test. They will     fill out a Crohn's Disease Activity Index questionnaire daily for 7 days and an Inflammatory     Bowel Disease questionnaire.      Participants will have G-CSF therapy. Before starting therapy, they will have a series of     pre-treatment tests, including a colonoscopy and leukapheresis. Colonoscopy is an examination     of the colon. For the procedure, patients are given a medication to lessen anxiety and any     discomfort. An endoscope-a lighted flexible tube-is inserted into the rectum, allowing     examination of the extent of inflammation. The endoscope can also be used to take pictures of     the colon and extract tissue samples for testing (biopsy). Leukapheresis is a procedure for     collecting quantities of white blood cells. Whole blood is collected through a needle placed     in an arm vein and circulated through a machine that separates it into its components. The     white cells are removed, and the rest of the blood is returned to the body, either through     the same needle used to draw the blood or through another needle placed in the other arm.      After the colonoscopy and leukapheresis, patients receive G-CSF injections every day for 29     days. The patient or a caregiver, such as a family member, will be taught to give the     injections. Blood samples will be collected on treatment days 4, 8, 11 and 15, and a physical     examination and interview, blood tests and a stool exam will be done once a week. Patients     will have a repeat colonoscopy and leukapheresis 24 hours after the last treatment dose (day     29).      After the 29-day treatment, patients will be followed in the clinic as follows:        -  Week 4 after treatment - physical exam and interview, routine blood work and stool exam        -  Week 8 - interview and blood work        -  Week 16 - interview, blood work and stool exam        -  Week 24 - physical exam and interview, blood work, stool exam and colonoscopy   "
167213|NCT00025818|"     A six-month clinical research trial to evaluate the effectiveness of an investigational     medication for the treatment of dry eye syndrome in patients that have been diagnosed with     moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or     older.   "
167214|NCT00025831|"     This study will collect biological samples-buccal cells, blood sample, skin sample-to be used     in developing and testing laboratory methods for measuring and analyzing genes. Such methods     can be used for research on identifying genetic factors that may affect a person's cancer     risk.      All individuals age 21 and older may participate in this study. Participants will provide one     or more of the following samples:        -  Buccal (mouth) cells - obtained by swishing a small amount of mouthwash in the mouth or          by swabbing or bushing the inside of the cheek with a swab or brush.        -  Blood - obtained by pricking the finger and collecting the drops or by blood drawing          through a needle placed in an arm vein.        -  Skin - obtained by a punch biopsy on the inner upper arm. For this procedure, the skin          is anesthetized and a small piece of skin is removed with a sharp instrument similar to          a cookie cutter. The wound is then covered and held together with a sterile bandage. A          small scar, approximately 1/8-inch long, will be left.      Most participants will be asked to provide only a buccal sample; blood and/or skin samples     will be requested from a few participants. The blood and skin samples may be used to grow     cell lines; that is, to make them grow indefinitely for research uses.   "
167215|NCT00025844|"     The purpose of this study is to use a computer-generated virtual reality environment to study     fear conditioning. Fear conditioning is used to explore the causes and persistence of anxiety     and anxiety disorders.      When confronted with fearful or unpleasant events, people can develop fear of specific cues     that were associated with these events as well as to the environmental context in which the     events occurred via a process called classical or aversive conditioning. Advances in     computer-generated visual stimulations could facilitate the design of new aversive     conditioning studies. This study will develop a virtual reality environment to examine human     contextual fear conditioning in the laboratory. During the procedure, moderately painful     stimuli will be administered. Participants in this study will be screened with a medical     history, physical examination, psychiatric evaluation, and hearing test. Participants will     wear headphones and special goggles that will enable them to view a virtual reality     environment. Measures will be taken during the study to see how the brain adapts to     environmental stimuli.   "
167216|NCT00025857|"     The purpose of this study is to use brain imaging technology to examine the brain activity of     adolescents with post-traumatic stress disorder (PTSD) and/or major depressive disorder (MDD)     before and after treatment.      Adults with PTSD or MDD exhibit abnormalities in the structure and function of certain parts     of the brain. Although PTSD and MDD are psychiatric disorders that often emerge in childhood,     the relationship between these disorders and brain structures has not been thoroughly studied     in adolescents with the disorders. This study will use functional magnetic resonance imaging     (fMRI) to study the parts of the brain that are involved in PTSD and MDD in adolescents.      Adolescents with PTSD and/or MDD will be enrolled along with healthy adolescents with or     without a history of abuse. Healthy adults will also be enrolled. Participants will be     screened with a physical examination; blood tests; and interviews about mood, general degree     of nervousness, and behavior. Adolescents and their parents will be interviewed separately     and together. Following the interviews, participants will undergo psychological tests.     Participants with PTSD and/or MDD will have two weekly sessions of talk therapy. Participants     who continue to experience PTSD or MDD symptoms after the talk therapy may continue the talk     therapy alone, begin treatment with fluoxetine (Prozac ) alone, or begin fluoxetine in     addition to the talk therapy. Participants who take fluoxetine will have blood collected     before treatment and 8 weeks after treatment has begun. If participants do not respond to the     treatment, the treatment will be stopped and the participants will be offered another     treatment. Participants who respond to treatment will continue treatment at NIH until a     referral to an outside physician is made. Depending on the experiment in which they are     enrolled, participants will undergo one or four MRI scans. Participants who will have four     MRI scans will undergo the scans on separate days. During the MRI, participants will complete     tasks on a computer. Saliva samples will be collected before and after the scans.     Participants with PTSD and/or MDD will collect their saliva one or two days before the MRI     scan.   "
167223|NCT00025974|"     The purpose of this study is to examine how certain brain chemicals work in patients with     Panic Disorder (PD) and Post-Traumatic Stress Disorder (PTSD) with and without major     depressive disorder (MDD).      Brain chemicals that regulate emotion, anxiety, sleep, stress hormones, and other body     functions bind to serotonin (5-HT1A) and benzodiazepine (BZD) receptors. Evidence suggests     that 5-HT1A and BZD receptor function is abnormal in patients with PD, PTSD, and depression.     This study will use positron emission tomography (PET) scans to examine BZD and 5-HT1A     receptor binding potential in patients with PD and patients with PTSD with and without     co-morbid MDD, as well as in healthy volunteers. This study will also determine the effects     of the stress hormone cortisol on 5-HT1A and BZD receptors.      The current emotional state and psychiatric, medical, and family history of potential     participants will be evaluated during an initial telephone interview. After entering the     study, participants will be asked questions about general mood, degree of nervousness, and     behavior. A physical examination, an electrocardiogram (EKG), and tests of intelligence and     cognition will be given. Urine, blood, and saliva samples will be taken. Women will be given     pregnancy tests and tests to determine menstrual phase and time of ovulation. All volunteers     will undergo magnetic resonance imaging (MRI) and PET scans of the brain.   "
167217|NCT00025870|"     This study will provide medical evaluations for patients with known or suspected metabolic     and genetic disorders. It will allow NICHD investigators and trainees experience in     diagnosing, managing, and treating patients with metabolic and genetic disorders who may not     be eligible for an active NIH research trial. Participants in this protocol will only have     tests and procedures used in the standard practice of medicine; there will be no experimental     tests or treatments. Patients who are found eligible for an active research protocol will be     offered participation in that study. The medical evaluations in this trial may uncover new     disease processes that prompt new research initiatives.      People of all ages with a suspected or diagnosed genetic or metabolic condition may be     eligible for this study. In addition, children with unexplained developmental delay,     deafness, dysmorphism, congenital malformations, acidosis, failure to thrive, feeding     problems, short stature, birth defects, and other syndromes of unknown cause may qualify.      Participants will have a medical history, including a family history, with possible review of     previous medical records, and a physical examination. Other procedures may include:        -  Consultation with medical specialists.        -  Hearing and/or vision tests.        -  Imaging studies, such as X-rays, ultrasound and magnetic resonance imaging (MRI).        -  Blood drawing Blood samples (2 to 4 tablespoons from adults and 1 to 2 tablespoons from          children) may be used for routine lab tests, genetic study, and other research purposes.        -  Cheek swab DNA may be obtained by a cheek swab. A small brush is rubbed against the          inside of the cheek to collect some cells.        -  Skin biopsy Under local anesthetic, a small circle of skin (about 1/8-inch) is removed          with a sharp cutting instrument similar to a cookie cutter.        -  Muscle biopsy Under local anesthetic, a small piece of muscle tissue is removed to aid          in diagnosis.      Participants will undergo only diagnostic procedures that are clinically indicated; that is,     only tests needed to confirm or rule out a diagnosis will be done. Tissue samples collected     for diagnostic purposes may also be used to obtain DNA for genetic studies and to establish     cell lines (cells grown in the laboratory to be maintained indefinitely) for future research.      The results of the medical evaluation may indicate whether or not the participant has the     disease that runs in the family (if a genetic disorder is indeed confirmed). Unless he or she     requests otherwise, the subject (and parent in the case of a minor) will receive counseling     regarding the test results. The implications of a positive test result will be explained,     specifically, the participant s risk of having the disease, and the risk of passing the     condition on to offspring.   "
167218|NCT00025883|"     This study will evaluate the safety and effectiveness of leptin replacement therapy in     patients with lipodystrophy (also called lipoatrophy). Patients have a total or partial loss     of fat cells. They also lack the hormone leptin, which is produced by fat cells. The leptin     deficiency usually causes high blood lipid (fat) levels and insulin resistance that may lead     to diabetes. Patients may have hormone imbalances, fertility problems, large appetite, and     liver disease due to fat accumulation.      Patients age greater than or equal to 6 months with significant lipodystrophy may be eligible     for this study. Participants will be admitted to the NIH Clinical Center for 10 days for the     following studies before beginning 12 months of leptin therapy:        -  Insulin tolerance test        -  Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies.        -  Fasting blood tests        -  Resting metabolic rate        -  Magnetic resonance imaging of the liver and other organs, and of muscle and fat.        -  Pelvic ultrasound in women to detect ovarian cysts.        -  Estimation of body fat        -  Oral glucose tolerance test        -  Intravenous glucose tolerance test        -  Appetite level and food intake        -  Hormone function tests        -  Questionnaires to assess activity and mood        -  24-hour urine collections      Additional studies may include blood tests for genetic studies of lipodystrophy, a muscle     biopsy to study muscle proteins involved in regulating energy expenditure before and after     leptin replacement, and examination of a surgical specimen (if available) to study molecules     that may be involved in energy storage and use.      When the above tests are completed, leptin therapy begins. The drug is injected under the     skin twice a day for 4 months and then once a day, if feasible. The dose is increased at the     1- and 2-month visits. Follow-up visits at 1, 2, 4, 6, 8 and 12 months after therapy starts     include a physical examination, blood tests and a meeting with a dietitian. At the end of 12     months, all baseline studies described above are repeated. Patients record their symptoms     weekly throughout the study. Those with diabetes measure their blood glucose levels daily     before each meal and at bedtime.   "
167219|NCT00025896|"     Pompe disease is caused by a deficiency of a critical enzyme in the body called acid alpha     glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored     form of sugar) within specialized structures called lysosomes. In infants with severe cases     of Pompe disease (called Classical Infantile Pompe disease), an excessive amount of glycogen     accumulates and is stored in various tissues, especially heart, skeletal muscle, and liver,     which prevents their normal function. This study being conducted to evaluate the safety and     effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme     replacement therapy for Pompe disease. Patients diagnosed with Classical Infantile Pompe     disease who have a small, but inactive, amount of natural GAA enzyme present in their bodies     (called Cross-Reacting Immunologic Material-Positive or CRIM (+) patients), will be     studied.   "
167220|NCT00025909|"     This study will evaluate the effects of intermittent short cycles of HAART (highly active     antiretroviral therapy) for treating HIV infection. HAART is a multi-drug regimen that is     very effective in suppressing HIV and perhaps slowing or halting progression to AIDS.     However, the treatment has significant drawbacks: it cannot completely rid the body of virus;     long-term therapy carries a risk of toxicity (harmful side effects); and the regimen is     difficult to comply with because many pills and capsules must be taken daily. When patients     stop taking HAART, their HIV levels climb again. This study will see if giving HAART in short     cycles of 7 days on, 7 days off, can keep viral levels low while maintaining CD4+ T cell     counts.      HIV-infected people age 18 or older who are receiving HAART and have a viral load of less     than 50 copies/ml and a CD4+ T cell count of at least 175 cells/mm3 may be eligible for this     study. Candidates will be screened with a medical history and physical examination, blood and     urine tests, and possibly a chest X-ray and electrocardiogram. Women of childbearing     potential will have a pregnancy test.      Participants will be randomly assigned to either continue their current medication regimen or     to take HAART in intermittent cycles of 7 days off, 7 days on. Patients will continue     treatment for 72 weeks or until viral levels increase or CD4+ T cell counts decline to a     level of concern.      Upon entering the study, patients will have blood tests to monitor the amount of virus in the     blood, CD4+ T cell count, viral resistance to HAART medications, side effects of the drug,     and immune response to HIV in the test tube. They will have clinic visits for a history,     physical examination and blood draws every month for 12 months. At that time, depending on T     cell counts and viral load, the number of visits may be reduced, but never less frequently     than every other month.      Patients will also undergo leukapheresis-a procedure for collecting quantities of white blood     cells-every 3 to 4 months while on the study. For this procedure, whole blood is collected     through a needle in an arm vein (similar to donating blood). The blood is circulated through     a cell separator where the white cells are removed, and the rest of the blood (plasma, red     cells and platelets) is returned through the same needle or through a second one in the other     arm. The collected white cells are used for special studies on the level and function of T     cells and to detect hidden virus.   "
167221|NCT00025922|"     This 2-part study will examine 1) the immune response to influenza (flu) vaccine in     HIV-infected patients, and 2) the effect of flu vaccine on HIV viral loads. Earlier studies     have shown that people with HIV infection do not respond as well to flu vaccine as healthy     subjects; that is, they don't make as many antibodies in response to the vaccine. Also,     studies done before the use of HAART (highly active antiretroviral treatment) have shown that     HIV levels increase for a period of time after flu vaccination. One small study showed a     small brief increase in HIV even in patients taking HAART. The current trial will examine     whether the flu vaccine does, in fact, cause an elevation in viral load and whether this     increase is harmful or indicates a better response to the vaccine.      HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be     eligible for part1of this study. (Healthy volunteers will serve as control subjects to make     sure the flu vaccine stimulates production of enough antibody to protect against the flu).     Part 2 will include only HIV-infected patients with fewer than 50 copies per milliliter of     HIV. Patients in both parts of the study must have been receiving HAART (consisting of at     least two nucleoside reverse transcriptase inhibitors plus a non-nucleoside reverse     transcriptase inhibitor or a protease inhibitor) for at least 3 months before enrollment in     the study. Candidates will be screened with a medical history and blood tests, including HLA     testing (a genetic test of immune system markers). Women who are able to have children will     have a pregnancy test. Pregnant women are excluded from the study.      Participants will undergo the following procedures:        -  Part 1 - Immune Response to Flu Vaccine      In the first of two visits, participants will have blood drawn for flu antibody levels before     vaccination and, in HIV-infected patients, measures of T cell count and viral load. They will     then receive the flu vaccine. Blood will be drawn at a second visit 28 days later for the     same tests.        -  Part 2 - Effect of Flu Vaccine on Viral Levels      Participants will be randomly assigned to receive the flu vaccine either at the beginning of     their enrollment in the study (immediate) or 3 weeks after enrollment (deferred). Those in     the immediate group receive the flu vaccine on the first day (day 0) and have blood drawn on     days 0, 3, 7, 10, 14, 17, 21, 24, 28, 31, 35, 38 and 42. Those in the deferred group are     vaccinated on day 21 and have blood drawn on days 0, 3, 7, 10, 14, 17, 21, 24, 28, 31, 35,     38, 42 and 49. The blood is tested for viral load, CD4 cell counts and antibody levels.   "
167224|NCT00025987|"     This study will evaluate the effectiveness of a specially designed head-neck cooling system     for way lowering the body's central, or core, temperature and cooling the brain. Brain     cooling has an effect on stopping seizure discharges in the brain as well as the seizures     themselves. If this system works to cool the brain, a similar study may be tried in patients     with epilepsy.      Normal volunteers 21 years of age and older who have no medical or neurological condition and     do not use any medications may be eligible for this study. Candidates will be screened with     an interview. Women will have a pregnancy test. Those enrolled will be hospitalized twice for     overnight stays, with the admissions 2 to 3 days apart.      Participants will have a medical history, physical and neurological examinations,     electroencephalogram (EEG) and electrocardiogram (EKG). Then, electrodes will be attached to     their scalp, forearm and calf to measure temperatures in those locations. Intestinal (core)     temperature will be measured with a temperature-sensing pill, which will be swallowed     earlier), and a hand-held infrared thermometer will be used to measure temperatures from the     ear canal, face, head, arms legs, and abdomen. Electrodes on the scalp will also measure     changes in blood volume in the brain for a study of brain blood flow. Subjects will be seated     in a comfortable chair and fitted with the cooling system, a portable unit with a circulating     coolant. Cooling will last 30 minutes for the first session and 60 minutes for the second.     Participants will be monitored for at least 30 minutes after each session to track     temperature changes and have a post-cooling EEG recording.   "
167225|NCT00026000|"     This study will investigate the brain areas that are activated by vocal and motor tics in     patients with Tourette's syndrome and other tic disorders. Tics are involuntary repetitive     movements similar to voluntary movements. They may be simple, involving only a few muscles or     simple sounds, or complex, involving several groups of muscles in orchestrated bouts. This     study will involve only simple motor tics, such as eye blinking, nose wrinkling, facial     grimacing and abdominal tensing, and simple vocal tics, such as throat clearing, sniffing and     snorting.      Healthy normal volunteers and patients between 14 and 65 years of age with simple motor or     vocal tics may be eligible for this study.      Participants will have a brief medical history and physical examination and magnetic     resonance imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to produce     images. For the procedure, the subject lies on a table that is moved into a cylindrical     chamber containing a strong magnet. Earplugs are worn to muffle the loud thumping sounds made     by electrical switching of the radio frequency circuits and protect against temporary hearing     impairment.      During the scan, normal volunteers will be asked to make simple movements or sounds designed     to imitate tics, such as raising eyebrows, blinking or coughing. Patients with tic disorders     will have two parts to the scanning session. First they will relax and allow tics to occur     spontaneously, then they will be asked to imitate a specific tic when there is no urge to     tic.      Patients and healthy subjects will have electromyography (EMG) to record the timing of the     voluntary movements and tics. For this procedure, several pairs of small, saucer-like     electrodes are attached to the skin with a gel or paste. Electric signals from the electrodes     are amplified and recorded on a computer. A microphone may be placed near patients to record     any vocal tics. A video camera may also be used to record the tics.   "
167226|NCT00026013|"     The purpose of this study is to evaluate the effects of a common herbal remedy, St. John's     Wort, on the effectiveness of birth control pills. St. John's Wort has recently been shown to     increase metabolism of some drugs. If it could increase metabolism of oral contraceptives as     well, it may increase the risk of contraceptive failure and unintended pregnancy. Study     participants will be evaluated for risk of ovulation on oral contraceptives before and during     simultaneous therapy with St. John's Wort.   "
167227|NCT00026026|"     The congenital absence of teeth, commonly referred to as hypodontia or tooth agenesis, is a     common developmental anomaly of human dentition that affects approximately 20% of the     population. Although new genetic and molecular approaches in humans and mice have increased     our understanding of the molecules that control tooth patterning (number, position, shape and     size), the precise nature of the genes involved in hypodontia in humans is poorly understood.     Hence, understanding the molecular basis for missing teeth is an issue of paramount     importance that is both timely and significant to the practice of dentistry. So far, only two     genes have been associated with non-syndromic familial tooth agenesis: MSX1 and PAX9.     Substitution mutations in the homeodomain region of MSX1 were linked to premolar agenesis     while an insertion mutation in the paired box domain of PAX9 was shown to be responsible for     molar oligodontia.      The long-term goals of this research are to elucidate the molecular pathology of human tooth     agenesis, in particular, to evaluate whether genes other than MSX1 and PAX9 (locus     heterogeneity) are involved. Alternatively, as in the case of MSX1, it will be interesting to     know whether allelic variations, different mutations in these genes, are associated with     tooth agenesis. We propose to study a potentially large kindred that report the developmental     absence of several posterior teeth. The fundamental hypothesis to be tested states that the     gene responsible for the congenital absence of molar teeth in this kindred is a critical     element in the genesis of molars. The specific goals are to perform linkage analysis followed     by direct sequencing of PCR products to identify the gene and to characterize the nature of     the underlying defect. Identifying the underlying gene defect in this family affected by     tooth agenesis will add new knowledge to our understanding of the pathogenesis of this defect     and will provide the basis for future studies.   "
167228|NCT00026039|"     To determine if estrogen hormone replacement therapy reduces the risk of stroke or death in     postmenopausal women who have already had stroke or a transient ischemic attack (TIA).   "
167229|NCT00026052|"     This study will examine the safety and effectiveness of the drug riluzole (Rilutek®     (Registered Trademark)) for short-term treatment of depression symptoms, such as depressed     mood, psychomotor retardation, and excessive sleeping. Despite the availability of a wide     range of antidepressant drugs, studies indicate that 30 to 40 percent of patients with major     depression do not respond to first-line antidepressant treatment with drugs such as     fluoxetine, upropion, venlafaxine and others. Riluzole, which is approved by the Food and     Drug Administration (FDA) for amyotrophic lateral sclerosis (ALS), causes chemical changes in     the brain that may also have antidepressant properties.      Patients between 18 and 70 years of age with major depressive disorder without psychotic     features may be eligible for this 2-stage 7-week study. Candidates will be screened with a     medical history and physical examination, including an electrocardiogram (EKG), blood and     urine tests, and a psychiatric evaluation. A      blood or urine sample will be tested for illegal drugs.Women of childbearing potential will     have a pregnancy test.      Participants will complete stage 1 of the study, which lasts 1 week, and may then continue     with stage 2 for an additional 6 weeks. At the start of the study, patients will be tapered     off all psychiatric medicines and will begin treatment with a placebo (a sugar pill     formulated to look like the active drug). At some point, they will be switched from placebo     to riluzole. In addition, participants will undergo the following procedures:        -  Physical examination and electrocardiograms (EKG) at the beginning and end of the study,          with vital signs (temperature, blood pressure and heart rate) checked daily        -  Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to          assess treatment response        -  Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects      At the end of the study, participants' psychiatric status will be reassessed and appropriate     long-term psychiatric treatment arranged.      Patients, ages 18 to 70 with a diagnosis of major depression without psychotic features, will     in this pilot study (single arm, single blind) receive riluzole (50-200 mg/day) for a period     of 6 weeks. Acute efficacy will be determined by demonstrating a greater response rate using     specified criteria.      Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6 weeks     of acute riluzole treatment. Therefore, if 7/22 patients or greater have greater than 50%     improvement on the primary efficacy measure, then based on statistically guidelines from the     Optimal Two Stage Design for Clinical Trials, a controlled trial would be indicated to     scientifically confirm the signal observed in the single arm trial.   "
167245|NCT00026260|"     RATIONALE: Biological therapy with drugs such as SU5416 may stop the growth of cervical     cancer by stopping blood flow to the tumor.      PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have     persistent or recurrent cervical cancer.   "
177590|NCT00165412|"     The purpose of this study is to determine if the use of breast MRI in detecting breast     malignancies in survivors of Hodgkin's disease is more successful than the traditional     mammogram.   "
167230|NCT00026065|"     Hypertension, present in more than 50 million Americans, increases the risk of cardiovascular     disease and its associated complications. More persons are turning to alternative medicine to     deal with their health problems. Biofeedback may reduce blood pressure and/or allow the     reduction of antihypertensive medications in some patients, while having no adverse effects.     Yet biofeedback therapy is time-intensive and technician-intensive. Therefore, it is critical     to be able to predict which patients with essential hypertension are most likely to lower     his/her blood pressure using these techniques. This research proposes to test three different     means of predicting whether a hypertensive subject will or will not be successful in lowering     his/her blood pressure using biofeedback. Sixty hypertensive subjects will be studied over a     three-year period. The results of this study will enable those caring for hypertensive     persons to recommend biofeedback in an individualized way, thereby promoting adherence.   "
167231|NCT00026078|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating     women who have metastatic breast cancer.   "
167232|NCT00026091|"     Phase II trial to study the effectiveness of fenretinide in treating patients who have     recurrent or metastatic ovarian epithelial or primary peritoneal cancer. Drugs used in     chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing   "
167233|NCT00026104|"     Randomized phase II trial to compare the effectiveness of gemcitabine, paclitaxel, and     radiation therapy with or without tipifarnib in treating patients who have locally advanced     pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     tumor cells. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary     for tumor cell growth. Combining chemotherapy and radiation therapy with tipifarnib may be an     effective treatment for pancreatic cancer.   "
167234|NCT00026117|"     RATIONALE: Shark cartilage extract may help shrink or slow the growth of colorectal cancer or     breast cancer cells.      PURPOSE: Randomized phase III trial to determine the effectiveness of shark cartilage in     treating patients who have advanced colorectal cancer or advanced breast cancer.   "
167235|NCT00026130|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation     therapy in treating patients who have locally advanced pancreatic cancer.   "
167236|NCT00026143|"     Phase II trial to study the effectiveness of combining interleukin-12 and interferon alfa in     treating patients who have metastatic malignant melanoma. Interleukin-12 may kill tumor cells     by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill     cancer cells. Interferon alfa may interfere with the growth of the cancer cells. Combining     interleukin-12 and interferon alfa may kill more tumor cells.   "
167237|NCT00026156|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of vinorelbine followed by docetaxel in     treating patients who have advanced non-small cell lung cancer.   "
167238|NCT00026169|"     Phase I trial to determine the dose of imatinib mesylate that is most effective with the     least amount of toxic side effects in treating patients who have advanced cancer and kidney     failure. Imatinib mesylate may stop the growth of cancer cells by stopping the enzyme     necessary for cancer cell growth. Kidney failure may delay the elimination of imatinib     mesylate from the body, which may lead to longer drug exposure and increase toxic side     effects   "
167239|NCT00026182|"     Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or     deliver cancer-killing substances to them without harming normal cells. Interleukin-12 may     kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white     blood cells to kill cancer cells. Combining rituximab with interleukin-12 may kill more     cancer cells. This randomized phase II trial is comparing how well giving rituximab together     with two different schedules of interleukin-12 works in treating patients with B-cell     non-Hodgkin lymphoma.   "
167240|NCT00026195|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Aging may affect the way these drugs work.      PURPOSE: Phase I trial to determine the relationship between aging and the effectiveness of     irinotecan in treating patients who have solid tumors.   "
167241|NCT00026208|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with low-dose radiation therapy works in treating patients with stage I or stage IIA     Hodgkin's lymphoma.   "
167242|NCT00026221|"     This randomized phase II trial is studying giving bevacizumab together with interferon alpha     to see how well it works compared to giving bevacizumab alone in treating patients with     metastatic malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block cancer     growth in different ways. Some block the ability of cancer cells to grow and spread. Others     find cancer cells and help kill them or deliver cancer-killing substances to them. Interferon     alpha may interfere with the growth of the cancer cells and slow the growth of the tumor.     Combining bevacizumab with interferon alpha may kill more tumor cells.   "
167243|NCT00026234|"     Phase II trial to study the effectiveness of hepatic arterial infusion plus chemotherapy in     treating patients who have colorectal cancer metastatic to the liver. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Giving the drugs in different combinations and different ways may kill more tumor cells.   "
167244|NCT00026247|"     RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases.      PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing     pain in patients who have bone metastases.   "
177650|NCT00167908|"     The purpose of this study is to determine whether Amifostine provides additional protection     of salivary gland function over that achieved with IMRT alone.   "
167247|NCT00026286|"     RATIONALE: Hormone replacement therapy may be effective in managing the hot flashes and/or     vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of hormone replacement     therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are     receiving tamoxifen for breast cancer.   "
167248|NCT00026299|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Biological therapies such as gefitinib may interfere with the     growth of the tumor cells and slow the growth of colorectal cancer. Combining chemotherapy     with gefitinib may kill more tumor cells.      PURPOSE: Phase I/II trial to compare the effectiveness of chemotherapy with or without     gefitinib in treating patients who have metastatic or locally recurrent colorectal cancer.   "
167249|NCT00026312|"     This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin,     and sargramostim to see how well it works compared to isotretinoin alone following stem cell     transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as     isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal     antibodies, such as dinutuximab, may block tumor growth in different ways by targeting     certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to     kill cancer cells. It is not yet known if chemotherapy is more effective with or without     dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating     neuroblastoma.   "
167250|NCT00026338|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Biological therapies such as erlotinib use different ways to     stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and     biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more     effective with or without erlotinib in treating pancreatic cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and     without erlotinib in treating patients who have unresectable locally advanced or metastatic     pancreatic cancer.   "
167251|NCT00026351|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells     and either kill them or deliver cancer-killing substances to them without harming normal     cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and rituximab in     treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.   "
167252|NCT00026364|"     Phase I trial to study the effectiveness of ZD 1839 combined with irinotecan, leucovorin, and     fluorouracil in treating patients who have locally advanced, locally recurrent, or metastatic     colorectal cancer. Biological therapies such as ZD 1839 may interfere with the growth of     tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways     to stop tumor cells from dividing so they stop growing or die. Combining ZD 1839 with     combination chemotherapy may kill more tumor cells.   "
167253|NCT00026377|"     RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor.     Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide,     bicalutamide, leuprolide, or goserelin may fight prostate cancer by reducing the production     of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining     SU5416, hormone therapy, and radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of SU5416 plus hormone therapy and     radiation therapy in treating patients who have prostate cancer.   "
167254|NCT00026403|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation     therapy in treating patients who have locally advanced pancreatic cancer.   "
167255|NCT00026416|"     RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.     Interferon alfa may interfere with the growth of cancer cells. Combining interferon alfa and     thalidomide may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa and     thalidomide in treating patients who have undergone surgery for soft tissue sarcoma or bone     sarcoma.   "
167256|NCT00026429|"     RATIONALE: Biological therapies such as denileukin diftitox may be able to deliver     cancer-killing substances directly to non-Hodgkin's lymphoma cells.      PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating     patients who have non-Hodgkin's lymphoma.   "
167257|NCT00026442|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of     capecitabine in treating women who have advanced or metastatic breast cancer.   "
167258|NCT00026468|"     RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in     patients who have familial adenomatous polyposis.      PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in     preventing the development and growth of polyps in patients who have familial adenomatous     polyposis.   "
167259|NCT00026494|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of temozolomide and vinorelbine in     treating patients who have recurrent brain metastases.   "
167260|NCT00026520|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth     of the tumor. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.     Combining interferon alfa with thalidomide may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with     thalidomide in treating patients who have stage IV melanoma.   "
167315|NCT00010231|"     RATIONALE: Combining calcitriol with dexamethasone may increase the effectiveness of therapy     by making cancer cells more sensitive to dexamethasone.      PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with dexamethasone     in treating patients who have prostate cancer that has not responded to previous hormone     therapy.   "
167262|NCT00026546|"     The purpose of this study is to determine how the brain controls motor activity in children     with attention deficit hyperactivity disorder (ADHD).      The inability to control one s behavior is an important symptom of many psychiatric     illnesses. The stop signal paradigm which involves withholding a motor response to a go     signal, has proved useful in assessing uncontrolled behavior in children with ADHD and other     disorders. This study will use a stop signal paradigm in order to evaluate the ability of     children with and without ADHD to control their motor behavior. A magnetic resonance imaging     (MRI) scan will be used to study how the brain works during specific activities.      This study will evaluate the stop signal paradigm in three groups of people: healthy     children, children with ADHD, and healthy adults. This study comprises two sub-studies: a     behavioral study in which participants perform simple activities and an MRI study.      Participants will be asked to stop any over-the-counter medication 5 days before entering the     behavioral or MRI study. Children with ADHD will be asked to stop taking medication for ADHD     72 hours before the study. All participants will have a medical history and a psychiatric     evaluation (for children, both parents and children provide information for the assessment).     Participants in the MRI study will also have physical examinations and blood and urine tests.     All children will undergo intelligence tests; and those with ADHD will have tests to confirm     the diagnosis. The parents of child participants will complete an autism screening     questionnaire.   "
167263|NCT00026559|"     This study has several parts. One part will examine the influence of factors such as     personality and past experience on reactions to unpleasant stimuli. Others will examine the     effect of personality and emotional and attentional states on learning and memory.      When confronted with fearful or unpleasant events, people can develop fear of specific cues     that were associated with these events as well as to the environmental context in which the     events occurred via a process called classical conditioning. Classical conditioning has been     used to model anxiety disorders, but the relationship between stress and anxiety and     conditioned responses remains unclear. This study will examine the relationship between cued     conditioning and context conditioning . This study will also explore the acquisition and     retention of different types of motor, emotional, and cognitive associative processes during     various tasks that range from mildly arousing to stressful.   "
167264|NCT00026585|"     The purpose of this study is to examine how the drug tamoxifen affects the brain in patients     with bipolar I disorder.      Bipolar Disorder (BD) is a severe, chronic, and often life-threatening illness for which safe     and effective treatments are necessary. The mood stabilizing effects of lithium and valproate     have revolutionized the treatment of patients with BD. However, a significant percentage of     patients do not respond fully to these drugs, and the biochemical basis for the antimanic and     mood-stabilizing actions of lithium and valproate is unclear. Both drugs inhibit protein     kinase C (PKC). There is a need to investigate the efficacy of a direct PKC inhibitor in the     treatment of acute mania. Tamoxifen is currently the only relatively selective PKC inhibitor     available for human use.      Participants in this study will be screened with a physical, psychiatric, and eye examination     and blood and urine tests. Eligible participants will be hospitalized at the Clinical Center     for at least 4 weeks. They will be tapered off all psychiatric medication and kept drug free     for 2 to 7 days. They will also be put on a low-monoamine, low-caffeine diet. Participants     will be randomly assigned to receive either tamoxifen or placebo (an inactive pill) for 3     weeks. During this time, participants will have daily pulse and blood pressure measurements,     several electrocardiograms (EKGs), and blood draws. Weight measurements will be taken at     least twice during the study, and caffeine or dextromethorphan will be given at the beginning     and end of the study to test how tamoxifen affects the way the body eliminates other     medications. Participants will have a physical examination at the end of the study.      At the end of this 4-week study, some participants may continue the study and will receive     tamoxifen for an additional 3 weeks. At the conclusion of the study, participants'     psychiatric status will be reassessed and long-term psychiatric treatment for their mood     disorders will be arranged.   "
167265|NCT00026598|"     The purpose of this study is to investigate how changes in the brain associated with     Parkinson's disease influence the control of motor and thinking speed. There is disagreement     over whether patients with Parkinson's disease are slow in thinking as well as movement. This     study may provide a new framework to explain the relationship between motor and cognitive     aspects of human behavior and help to clarify the pathophysiology of Parkinson's disease.      There are two parts to the study: behavioral tests and functional magnetic resonance imaging     (fMRI). All participants will be asked about their medical history, have a physical     examination, and complete a questionnaire. They must not take regular medications, including     levodopa and dopamine agonists, for 8 hours prior to the study.      The behavioral study involves computer-generated neuropsychological tasks, including hand     movements, imagination of movements, and mental calculations. Response will be recorded and     evaluated. Electrodes may be placed on the participant's skin to measure surface     electromyogram (EMG).      The fMRI study involves MRI scanning in which motor and thinking tasks are performed.     Electrodes may be placed on the skin to monitor muscle activity.      Thirty patients, ages 40 and up, with early-stage Parkinson's disease will be recruited.     Sixty normal volunteers ages 21-75 will be included as well for comparison.   "
167266|NCT00026611|"     The purpose of this study is to see how many people respond to a smallpox vaccine when a sore     forms where the shot was given.      The world was declared free of smallpox in 1980. General routine vaccinations for smallpox     were stopped in the U.S. in 1971. In 1976, the recommendation for routine vaccination of     healthcare workers was also discontinued. The only people who presently receive this vaccine     are people who work with vaccinia virus or monkeypox virus. Because the world was considered     free of smallpox infections, this vaccine was no longer produced; there is a limited supply     available in the United States.      Because of the limited amount of Dryvax vaccine (vaccinia virus) against smallpox, this study     will look at the ability to dilute the vaccine making more doses available in the event of a     smallpox outbreak. The study seeks to characterize a strategy of vaccination against smallpox     with various doses of Dryvax, followed by revaccination with the same dose, if required, in     volunteers 18-32 years of age with a negative history of smallpox vaccination.   "
167267|NCT00026624|"     The purpose of this study is to determine how safe it is to give patients a shot that has a     mixture of a vaccine and dendritic cells (DCs), a special kind of immune cell, and how safe     it is to give a shot of the vaccine alone.      Current HIV vaccines have not been strong enough to give good immune responses. Research has     shown that the immune response to a vaccine delivered by DCs is greater than the response     without DC delivery. A5130 is a study that seeks to give good delivery of the vaccine to     important immune cells of the body.   "
167268|NCT00026637|"     To define the benefits of antidepressant treatment or cognitive behavior therapy on mood,     function, and quality of life in persons with depression and refractory epilepsy.   "
178066|NCT00175825|"     This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50     mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.   "
167269|NCT00026650|"     Background:      -This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our     patients, to continue to follow those who have been treated with radiotherapy at ROB and are     not otherwise eligible for current active research protocols. it also provides a mechanism     for the correlation and interpretation of disparatc data for research into the long term side     effects and outcomes for a variety of disease entities and treatments, such as combined     modality treatment, MoAb, PDT, radiation modifiers, intraoperative radiotherapy, etc.      Objectives:      -The objective of this protocol is to provide follow-up care for patients previously treated     with radiotherapy in the Radiation Oncology Branch (ROB) in order to assess the late effects     of treatment and the natural history of disease.      Eligibility:      -Patients who received radiation therapy at the NCI IRB who are long-term survivors and are     not currently entered on an active research protocol.      Design:      -This is a natural history protocol that will provide follow-up care for Radiation Oncology     Branch patients and will allow for appropriate long-term follow up care and evaluation,     including NIH consultation services as required. It will be made clear to patients in the     consent form, that data collected in their follow-up may be used anonymously for publications     concerning the natural history of disease processes and long term effects of treatment.   "
167270|NCT00026663|"     This study will examine blood, bone marrow, tumor and tissue samples from patients with     cancer to study tumor resistance to chemotherapy (drug treatment). Many patients with cancer     improve initially with chemotherapy, but then have a disease relapse, after which their tumor     no longer responds to treatment. Other patients tumors are drug-resistant from the start. The     study will look for resistance factors substances in blood and tissues that render tumors     resistant to chemotherapy. The findings may provide information needed to develop methods of     combating drug resistance.      Patients with cancer who are 18 years or older may be eligible for this study. Participants     will have 40 milliliters (3 tablespoons) of blood drawn at the beginning of the study;     additional samples will be obtained periodically during the course of treatment. A small     sample of tumor or normal tissue will be taken from patients who undergo surgery or tumor     biopsy (removal of a small piece of tumor) for medical reasons or as part of a research     treatment protocol. Patients who do not require surgery or biopsy may be asked permission to     obtain a tumor sample. Depending on the location of the tumor, this may be done by: 1)     withdrawing bone marrow through a small needle; 2) removing fluid from the chest or abdomen;     3) removing a small tumor sample through a needle; or 4) removing the sample with a small     incision into or around the tumor. These procedures will be done only if they are of low risk     to the patient.   "
167271|NCT00026676|"     Recent studies have shown that patients receiving state-of-the-art treatment for HIV     infection (highly active antiretroviral therapy, or HAART) show discordant responses to     therapy-that is, they improve both clinically and immunologically (increased CD4 immune cell     counts), but their levels of HIV in the blood do not drop. This study will examine blood     samples taken from HIV-infected children treated with 2',3'-dideoxyinosine (didanosine, or     ddI) in an earlier NCI study to determine if these patients had similar discordant responses     to therapy. If so, the study will also examine how these factors may be predictive of disease     progression and survival.      Investigators will measure HIV levels in blood specimens from children previously enrolled in     NCI protocol 88-C-0129. The measurements will be done in specimens drawn before initiation of     treatment with ddI and at various times during the course of treatment. The viral responses     to therapy will then be correlated with short- and long-term clinical and immunologic     outcomes.      In addition, researchers will examine these patients' blood samples for additional factors     recently discovered to potentially influence disease progression. They include selenium     levels and certain genetic factors.      A better understanding of discordant responses to therapy will help physicians determine the     best treatment option in situations where therapy results do not show uniform benefit.      This protocol involves the scientific examination of laboratory specimens only and is not a     clinical study open to patient enrollment.   "
167272|NCT00026689|"     Background:      -This protocol will provide a means for screening potential candidates for NCI Radiation     Oncology Branch (ROB) protocols.      Objectives:      -To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to     identify individuals who will be suitable candidates for Radiation Oncology Branch clinical     research protocols.      Eligibility:      -Patients suspected of having, or with biopsy proven malignant disease or patients with a     benign condition for whom radiotherapy is a potential treatment.      Design:      -This is a screening protocol. No investigational treatments will be administered on this     protocol.   "
167273|NCT00026702|"     The purpose of this study is to find substances in the blood and urine that indicate that a     person has kidney damage. It will identify proteins found only in patients with acute kidney     failure but not in normal healthy people or in patients with volume depletion.      Adults and children who are at least 3 years old who fall into one of the following four     categories may be eligible for this study:        1. Are healthy and have normal kidney function        2. Have volume depletion (this condition differs from acute kidney failure in that it is          easily treated with fluids)        3. Are at high risk of kidney failure        4. Have acute kidney failure (kidney shutdown)      All study participants will have a history and physical examination. Up to four blood samples     of 3 tablespoons each will be taken for laboratory analysis. Urine will be collected for     analysis and to measure urine output. The participants length of stay in the study varies.     People with normal kidney function will be in the study for 1 day and patients with volume     depletion will be studied 3 days. The length of hospitalization of patients at high risk of     kidney failure or in acute kidney failure will depend on the patient s condition and     medication requirements.      The results of this study may lead to the development of earlier and more accurate methods     for diagnosing acute kidney failure. With earlier detection, treatment could be started     earlier, possibly preventing further damage and helping recovery of injury that has already     occurred.   "
167308|NCT00010140|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Hormone therapy using tamoxifen may fight breast cancer by blocking     the uptake of estrogen by the tumor cells. Combining chemotherapy with hormone therapy may     kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and tamoxifen     with or without docetaxel in treating postmenopausal women who have breast cancer that has     spread to the lymph nodes.   "
167274|NCT00026715|"     This study will test the accuracy of a new Fast GFR (glomerular filtration rate) test to     evaluate kidney function. Accurate assessment of kidney function is important in many     clinical situations, including detecting kidney disease early, determining appropriate drug     dosages, deciding when to begin dialysis, and evaluating heart and kidney organ donors and     recipients. The current GFR test is used mostly for research purposes, as it is too costly     and complicated for general medical use. Another significant drawback to its use in     diagnosing acute kidney failure is the time it takes (3 to 24 hours) to complete, since     effective therapy for this condition requires its detection as soon as possible. The Fast     GFR, by comparison, takes only 45 minutes.      Patients 6 years old and older with kidney disease or with impaired kidney function caused by     abnormal heart function or swelling-from congestive heart failure, severe infections,     swelling from fluid accumulation, fluid in the abdomen, or burns-may be eligible for this     study. Patients will undergo both the standard and the Fast GFR tests, described below, to     evaluate the accuracy of the new test.      Fast GFR: Two catheters (thin flexible tubes) are placed into two arm veins, one for     injecting iothalamate-an agent commonly used in CT scanning and blood vessel imaging-and the     other for collecting blood samples. Baseline blood and urine samples are collected and then     0.5 milliliter (ml) iothalamate is injected into a vein. Blood samples are collected at 5,     10, 15, 20, 30, and 45 minutes in adults and at 5, 15, and 45 minutes in children. Urine is     collected at 45 minutes. The size of the bladder is measured using ultrasound to determine if     the bladder has completely emptied.      Standard GFR: Iothalamate (1 ml) is injected under the skin. Blood samples are collected at     60, 90, 120, 180 and 240 minutes. (A heparin lock is used to avoid multiple needle sticks.)     Urine is collected at 60, 90, 120, 180 and 240 minutes. The size of the bladder is measured     using ultrasound to determine if the bladder has completely emptied.   "
167275|NCT00026728|"     This study will investigate patterns of Kaposi's sarcoma herpes virus (KSHV) in the United     States and its potential impact on the U.S. population. KSHV is a newly discovered virus that     is strongly associated with Kaposi's sarcoma and primary effusion lymphoma. The high     prevalence of KS and KSHV among HIV-infected homosexual men suggests sexual contact as a     primary mode of transmission. Reports of non-sexual transmission in parts of Africa and the     Mediterranean where Kaposi's sarcoma is endemic, and the identification of viral DNA in     saliva and other bodily fluids, however, indicate the virus is also transmitted non-sexually.     This study will:        -  Compare the prevalence of KSHV among different demographic groups in the United States        -  Examine the association between KSHV and high risk behaviors such as drug use (marijuana          and cocaine), sexual behavior (age at first sexual intercourse and number of sexual          partners), and medical risk factors (herpes simplex virus II, hepatitis B and hepatitis          C)        -  Estimate the prevalence of KSHV in the United States.      Data and blood samples for the study will be taken from the NHANES III survey. NHANES is a     program of periodic surveys conducted by the Centers for Disease Control and Prevention's     National Center for Health Statistics. The survey is designed to provide national estimates     of health status for the United States non-institutionalized civilian population by means of     household interviews, standardized physical examinations, and blood sample collection and     testing. NHANES III-the seventh in a series of national examination studies-was conducted     from 1988 to 1994.      This study will use the HANES data to identify risks associated with a KSHV-positive blood     test in the survey population. The study plans to include all 19,754 participants (67% of the     29,314 participants originally examined) for whom blood samples were collected and remain     available.   "
167276|NCT00026741|"     This study will examine the production of proteins called chemokines in inflammatory skin     reactions. It is thought that chemokines attract or recruit white blood cells from the blood     stream into the skin when there is a skin injury or infection, causing inflammation. This     study will examine chemokine production in induced inflammatory reactions to try to gain a     better understanding of how white blood cells are attracted to inflamed areas of the body.      Healthy normal volunteers between 33 and 60 years old may be eligible for this study if they     1) have no history of chronic skin disease; 2) are not allergic to eggs; and 3) do not tend     to form large irregular scars after trauma to the skin from, for example, cuts, scratches and     surgical incisions. Candidates will be asked a short series of questions and have a limited     skin examination.      Participants will have 10 ml (2 tablespoons) of blood drawn from an arm vein at the start and     end of the 5-day study and undergo the following procedures:        1. Day 1 - Participants receive an injection in the right upper arm of mumps antigen (a          protein commonly used to tests for immunization against mumps) and an injection of          vehicle (saline plus the preservatives thimerosal, glycine and formaldehyde) in the          left upper arm.        2. Day 3 - Participants who develop a swelling from the mumps antigen larger than 5 mm wide          will receive another injection of antigen in the right arm and another injection of          vehicle in the left arm. Those whose swelling is not greater than 5 mm will be excluded          from the study at this point.        3. Day 5 - All four injection sites, plus another site on the left upper arm will be          biopsied. For this procedure the five injection areas are numbed with a local          anesthetic. A punch biopsy instrument that resembles a small cookie cutter (about          one-third the diameter of a dime) is inserted about one-fifth of an inch deep into the          skin and the tissue is removed. Two stitches are used to close the wound. Antibiotic and          bandages are applied for 5 days. Nine days after the biopsy the participant returns to          NIH for removal of the stitches.      New molecular biology techniques will be used to measure changes in chemokine production in     the biopsied tissue.   "
167278|NCT00026767|"     This study will collect data on the incidence (rate of occurrence) of fungal infections in     recipients of bone marrow, stem cell or organ transplants. The data will provide information     needed to develop strategies for prevention and early treatment of fungal infections in these     patients.      Any patient receiving bone marrow transplantation, peripheral stem cell transplantation or     solid organ transplantation is eligible for this study.      The survey will be conducted over a 3-year period at about 20 collaborating transplant     centers. Through the annual accrual of more than 9,000 patients, it is estimated that at     least 5 to 8 percent per year will have documented or suspected invasive fungal infections.      The study will be conducted in three phases as follows:        -  Phase 1 A 6-month start-up phase during which sites will initiate screening and begin          collecting data on incident cases of invasive fungal infections.        -  Phase 2 A 2-year phase in which all sites will conduct surveillance and collect data and          specimens in a standardized fashion.        -  Phase 3 A 6-month wrap-up phase during which active surveillance for invasive fungal          infections will be conducted only among patients who were transplanted before the          beginning of this phase.      Patient care will be provided through the patient s primary protocol and standard of care.   "
167309|NCT00010153|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent     metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer     metastases.      PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before     surgery in treating women who have stage I or stage II primary breast cancer.   "
170773|NCT00073528|"     This study will compare the efficacy and tolerability of GW572016 administered in combination     with letrozole, versus letrozole and placebo, as treatment for hormone receptor-positive     advanced or metastatic breast cancer.   "
167284|NCT00026858|"     Most bone marrow transplantations for malignant and non-malignant disease include whole body     irradiation. Techniques for administering that treatment, including patient positioning, lung     and soft tissue compensation, dose rate, total dose and fractionation differ between     institutions. These differences are optimized at each institution to limit toxicity and     maximize therapeutic outcome.      Technically complex procedures such as total body radiation are subject to equipment     failures. Such failures mid-treatment could be catastrophic to the patient, since therapy     must be timely and compatible therapy may not be available elsewhere in the community. The     purpose of this protocol is to provide backup between George Washington University Medical     Center and the Radiation Oncology Branch of the NCI to allow for orderly, safe, and     compatible therapies in the event of equipment failure; or replacement of a linear     accelerator or any other malfunctioning equipment necessary to deliver TBI; or any emergent     situation.   "
167279|NCT00026780|"     Patients who are being considered for participation in a NCI Pediatric Oncology Branch     research study will be screened for eligibility under this protocol. For every NCI research     study, patients must meet defined medical criteria in order to ensure the integrity of the     research study and to maximize patient safety.      Tests and procedures required for determining eligibility depend on the specific study for     which the patient is being considered. Some of the more common tests and procedures are:        -  History and physical examination        -  Blood and urine samples for routine laboratory tests and possibly research studies        -  Quality of life assessment questionnaire        -  Magnetic resonance imaging (MRI) scan uses a magnetic field and radio waves to produce          pictures of body structures, including tumors        -  Computerized tomography (CT) scan uses radiation to produce multiple detailed pictures          of body structures        -  X-rays uses radiation to provide a single picture of a body part        -  Nuclear medicine scans uses a chemical tagged with a radioactive substance to detect          tumors, measure kidney or heart function, or monitor the flow of cerebrospinal fluid          (fluid that bathes the brain and spinal cord)        -  Electrocardiogram (EKG) uses electrodes placed on the skin to evaluates heart rate and          rhythm by measuring electrical impulses from the heart        -  Echocardiogram uses high-frequency sound waves to evaluate heart structure and function        -  Lumbar puncture tests for cancer cells and other substances in cerebrospinal fluid.          Involves placing a needle into the lower back between the bones of the spine and          withdrawing a fluid sample from the fluid-containing space below the spinal cord        -  Ommaya reservoir surgically implanted catheter inserted into the fluid-filled ventricles          of the brain, used to withdraw spinal fluid samples and to give medication        -  Eye examination vision test and eye examination        -  Biopsies removal of a small piece of tissue, by needle or by surgery, for examination          under the microscope. An area of skin over the biopsy site is numbed with an anesthetic.          For a needle biopsy, a needle is inserted into the tumor, tissue or bone marrow to pull          out a small sample. A surgical biopsy may be done in the operating room, clinic, or          hospital room, depending on the biopsy location. The tissue or tumor is removed by          cutting a small piece of it with a sharp knife or scalpel and the area will be closed          with sutures or staples.   "
167280|NCT00026793|"     The purpose of this study is to develop imaging techniques to determine the density of blood     vessels and the amount of blood flow in Kaposi s sarcoma (KS) tumors. KS tumors depend on the     formation of new blood vessels for their growth. Some experimental therapies for KS are     directed at reducing the amount of blood vessels and blood flow in these lesions. Measurement     of blood vessel density and blood flow in these lesions could be useful in evaluating the     effectiveness of both standard and experimental treatments for this disease.      Patients 18 years of age or older with Kaposi s sarcoma involving the skin may be eligible     for this study. Participants will have photographs taken of their lesions and will undergo     three imaging procedures (described below) at the beginning of the study (baseline) and then     about once every 3 months or so while on the study (up to 2 years) to compare the test     results over time. (Imaging may be done at more or less frequent intervals depending on the     findings.) A small amount of blood (less than a tablespoon) will be drawn the day of each     imaging procedure.      Laser Doppler imaging This technique measures the amount of blood flow in KS lesions by     scanning the lesions with a low-power laser beam. Each lesion takes about 3 minutes to scan.     The imaging may be done before and after a blood pressure cuff around the arm is inflated for     a short time (usually less than 30 seconds).      Multi-spectral imaging This technique uses light to measure the total blood volume in each     lesion and how much oxygen is in the blood. Oxygen is carried to the body s cells by a     protein in red blood cells called hemoglobin. The light on the multi-spectral imaging     instrument is absorbed differently depending on whether the hemoglobin has oxygen attached to     it or not. It takes about 2 minutes to scan each lesion.      Infrared thermal imaging This test uses a special camera to take digital infrared pictures of     the skin. Images formed of the temperature of the KS lesions are used to assess blood flow in     the lesions. This imaging takes about 1 minute per lesion.   "
167281|NCT00026806|"     This study will examine the emotional and behavioral aspects of long-term survival of     HIV/AIDS among adolescents and young adults with HIV infection.      HIV-infected individuals between 13 and 23 years of age may be eligible for this study. They     must be aware of their HIV diagnosis, have been infected for at least 13 years and have been     on an active NIH protocol during the past 5 years.      In addition to the usual stresses of growing up, children with HIV infection may have spent     much of their time in hospitals and may have lost parents, friends and other loved ones. This     study will explore psychological aspects of growing up with HIV, including self esteem,     possible risk behaviors, how disclosure to others changes over time, the commonness of     anxiety and depression, and the impact that losses have had on the adolescents' emotional     health. To gather this information, participants will be interviewed and asked to fill out a     set of forms. Caregivers will also fill out forms.      Patients who are not currently on an active NIH protocol will have the option of having a     physical examination and routine blood work. The results will be sent to their home care     provider.   "
167282|NCT00026819|"     This study will evaluate the ability of a new non-steroidal anti-inflammatory drug (NSAID)     called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food     and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis,     menstrual cramps, and pain.      Healthy normal volunteers between 16 and 35 years of age in general good health who require     third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be     screened with a medical history and oral examination, including dental x-rays as needed to     confirm the need for third molar removal.      Participants will have all four wisdom teeth extracted, and a biopsy (removal of a small     piece of tissue) will be taken from the inside of the cheek around the area behind the lower     wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard     anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill     with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine)     in the mouth and a sedative (midazolam) through an arm vein.      After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and     the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is     unrelieved an hour after surgery may request and receive morphine intravenously (through a     vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol     with codeine and the study drug) and instructions for their use. They will also be given a     pain diary to record pain ratings and medications taken at home. A clinic staff member will     telephone patients at home the morning after surgery to ensure they are rating their pain     intensity at the proper time and are taking their medications as instructed.      Patients will return to the clinic 48 hours after surgery with the pain diary and pain     relievers. At this visit, another biopsy will be taken under local anesthetic.   "
167283|NCT00026832|"     The purpose of this study is to evaluate the function of certain brain chemicals and     receptors in patients with mood disorders. This study will also examine how the stress     hormone cortisol affects brain function.      Data suggest that serotonin 1A (5-HT1A) receptor function is abnormal in patients with mood     disorders, such as major depressive disorder (MDD) and bipolar disorder (BP). However, these     data are limited because they are based on small sample sizes. In this study, PET scans will     be used to compare 5-HT1A receptor binding potential between mood disorder patients and     healthy volunteers.      All participants will have an initial medical and psychiatric evaluation. Depression     severity, anxiety, negative thinking, level of functioning, intelligence, and cognitive     functions will be measured. Urine, saliva, and blood will be collected. Women will have a     pregnancy test and tests to determine menstrual phase and time of ovulation. Participants     will undergo magnetic resonance imaging (MRI) and PET scans of the brain. Some participants     will have other procedures such as a lumbar puncture. Participants with Cushing's disease     will undergo imaging as a comparison group.   "
167310|NCT00010166|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may     make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation     therapy after surgery may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation     therapy in treating patients who have undergone surgery to remove cancer of the pancreas.   "
172303|NCT00097643|"     The purpose of this study is to examine the relative and combined efficacy of a physical     activity and health promotion program to help sedentary adults over age 70 maintain an     independent life style.   "
167285|NCT00026871|"     We propose to determine the response of a newly developed laser heated, vycor glass     fiberoptic radiation dosimetry system to ionizing radiation in a clinical radiotherapy     environment. Present systems measure only total dose or have limitations, such as     instability, non-linearity, excessive size or a decoupled measurement system, making them     unsuitable in a variety of clinical applications. This fiberoptic coupled dosimetry system is     a new and innovative technology application which allows on-line measurement of instantaneous     dose rate and total dose never before achievable. It offers a clear advantage in patient     treatment delivery, allowing on-line corrections essential to a new generation of     radiotherapy treatment machines with development of beam intensity modulation as an adjunct     to 3D conformal therapy. It also has the advantage of submillimeter size and is minimally     invasive, making it ideal for brachytherapy.      This system has the potential for stable, accurate, reproducible, clinically feasible     measurements of total dose and dose rate. The output of this system will be measured under     various clinical conditions encountered in a clinical setting and compared against existing     thermolumeniscent and diode dosimetry standards. Initial measurements will use a tissue     equivalent phantom for depth dose and accuracy measurements. Additional studies will include     dosimetric measurements of routine clinical treatment setups on patients receiving     therapeutic irradiation.   "
167286|NCT00026884|"     Selected patients suspected of having or with prior biopsy proof of malignant disease will be     seen in the Urologic Oncology Branch, NCI. Blood samples may be collected at the time of the     initial visit and at periodic intervals during the course of the disease. These samples will     be stored in the tissue bank of the Urologic Oncology Branch. Aliquots of malignant and     normal tissue will be collected at the time of surgery and stored in the tissue bank,     Urologic Oncology Branch, NCI. These materials will be used in the research efforts of the     Urologic Oncology Branch, NCI.   "
167287|NCT00026897|"     Patients undergoing immunotherapy for advanced cancer under IRB-approved protocols, who are     to receive immune cells in adoptive transfer, will have less than or equal to 50% of those     cells labeled with In-111-oxine and administered along with the remainder of their unlabeled     cells. They will then undergo gamma-camera imaging over the next 0-7 days and blood samples     and tumor sites which are accessible with minimal surgery (low-risk biopsy) may be sampled in     some patients for enumeration of radiolabeled cells. End-points will be tumor and normal     organ imaging and the amount of In-111 per gram of tissue in biopsies or per ml. of blood.   "
167288|NCT00026910|"     Although the cause(s) of clinical drug resistance in non-Hodgkin's lymphomas (NHL) are     unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of     apoptosis may play an important role. Clinical studies have now shown that p53, bcl-2 and     tumor proliferation all have significant effects on clinical drug resistance. To further     investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate     the expression of multiple molecular targets [including but not restricted to bcl-2, BAX,     bcl-6, MIB-1, p53, p21, p27, p16, cyclin D(1), cyclin A, cyclin E, mdm-2, cpp 32, mcl-1,     EBER-1, ALK, and a panel of B, T and other cell lineage markers], involving these pathways,     with clinical outcome following treatment with combination chemotherapy. All clinical data     and tissue samples for this study will come from patients who have been previously enrolled     on two protocols for the initial treatment of aggressive lymphomas. No new patients will be     enrolled for this study.   "
167289|NCT00026923|"     This study evaluates a system of remote supervision of laparoscopic surgery. Laparoscopic     surgery is performed through small holes in the abdomen called ports. A camera is passed     through one port for visualization. Laparoscopic surgery requires an assistant to hold the     camera and help the operating surgeon view the surgical field. The assistant camera holder     may be a surgeon or a robotic arm. The robotic arm is usually controlled by the operating     surgeon. In this study, a robotic arm holding the camera will be used, and will be controlled     by a surgeon outside the operating room.   "
167290|NCT00026936|"     The utility of PEREGRINE Monte Carlo calculations for radiation treatment planning in a     clinical setting will be assessed by comparing results with other fully three-dimensional     programs. ROB will investigate PEREGRINE for clinical use at NCI in collaboration with     Lawrence Livermore National Laboratory (LLNL).   "
167291|NCT00026949|"     This study will examine how the body handles etoposide, a drug used to treat breast cancer.     The knowledge gained may lead to more effective use of the drug with fewer side effects in     the future.      Breast cancer patients who are receiving etoposide as part of their treatment may participate     in this study. Patients will have 18 blood samples (about a teaspoon or less each) drawn over     a 72-hour period during and after their infusion of etoposide. The initial blood samples     cannot be taken from the same intravenous line (small tube placed in a vein) used to deliver     the etoposide, so a second line may have to be placed temporarily to obtain these samples.   "
167311|NCT00010179|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing of die.      PURPOSE: Randomized phase II trial to compare the effectiveness of two treatment regimens of     lurtotecan liposome in patients who have advanced or recurrent ovarian epithelial cancer,     primary fallopian tube cancer, or peritoneal cancer that has been previously treated with     chemotherapy.   "
167526|NCT00028574|"     RATIONALE: Gabapentin may be effective in relieving hot flashes in men who have prostate     cancer. It is not yet known which regimen of gabapentin is most effective in treating hot     flashes.      PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating     men who have prostate cancer.   "
167292|NCT00026962|"     Blood levels of the hormones estradiol and progesterone are of interest in evaluating ovarian     function. However, because these hormone levels vary from day to day, blood samples must be     taken very often or elaborately timed to specific phases of the menstrual cycle. A method has     now been developed for measuring estradiol and progesterone levels in saliva. This study will     test the accuracy of this method and examine whether salivary levels of these hormones change     after treatment with raloxifene.      Hormone levels will be measured during 3 menstrual cycles in women currently enrolled in the     clinical study, A Phase II Trial of Two Doses of Raloxifene in Women at Risk of Developing     Invasive Breast Cancer. Participants will provide a saliva sample every morning for about a     month during three collection periods-1 month before beginning raloxifene treatment, and 3     and 12 months after treatment starts. Patients will be given kits for collecting the samples     and mailing them to the laboratory at the end of each collection period.   "
167293|NCT00026975|"     This study is designed to develop a predictive model for the development of wound     complications in patients undergoing laryngectomy surgery for laryngeal/adjoining structure     cancers, and to evaluate the clinical efficacy of hyperbaric oxygen for the     prevention/management of wound complications in this previously irradiated population. The     eligibility profile welcomes the involvement of patients in need of laryngectomies for newly     diagnosed cancers and for failed chemoradiation. Patients are afforded the opportunity to be     cared for by some of the most distinguished head & neck surgeons and hyperbaric medicine     physicians at the University of Pennsylvania in Philadelphia, the oldest teaching medical     facility in the country, as well as the Philadelphia Veterans Affairs Medical Center. In     addition, participants will be contributing to a body of research uncovering new methods for     the assessment of tissue/tumor oxygenation, modeling to promote early wound complication     identification, and confirming the role of hyperbaric oxygen therapy in the care and     prevention of these problem wounds.   "
167294|NCT00026988|"     This study, CREST-HD, will examine the safety and tolerability of 8 grams of creatine in     subjects affected by Huntington's disease (HD). Biochemistry and neuroimaging will be used to     examine the potential effects of creatine on HD.   "
167295|NCT00009971|"     Phase II trial to study the effectiveness of fenretinide in treating patients who have     recurrent small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die.   "
167296|NCT00009984|"     This randomized phase II trial is studying thalidomide and fludarabine to see how well they     work compared to thalidomide alone in treating patients with hematologic cancer that has not     responded to previous treatment with fludarabine. Thalidomide may stop the growth of     hematologic cancer by stopping blood flow to the cancer. Combining thalidomide with     fludarabine may increase the effectiveness of chemotherapy by making cancer cells more     sensitive to the drug. It is not yet known whether thalidomide is more effective with or     without fludarabine for hematologic cancer.   "
167297|NCT00009997|"     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining monoclonal antibody therapy with combination chemotherapy may be an effective     treatment for locally advanced breast cancer.      PURPOSE: Phase I trial to study the effectiveness of trastuzumab plus paclitaxel followed by     surgery and combination chemotherapy in treating women who have locally advanced breast     cancer.   "
167298|NCT00010010|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     exemestane plus goserelin may fight breast cancer by reducing the production of estrogen.      PURPOSE: Phase II trial to study the effectiveness of exemestane and goserelin in treating     premenopausal women who have metastatic breast cancer that has not responded to previous     tamoxifen.   "
167299|NCT00010023|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor     cells.      PURPOSE: Phase I trial to study the effectiveness of capecitabine combined with cisplatin in     treating patients who have locally advanced or metastatic solid tumors .   "
167300|NCT00010036|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining carboplatin with irinotecan     in treating patients who have glioblastoma multiforme.   "
167301|NCT00010049|"     RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an     effective treatment for recurrent glioma and meningioma.      PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating     patients who have progressive, recurrent, or unresectable malignant glioma or meningioma.   "
167302|NCT00010062|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.      PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation     therapy in treating patients who have undergone surgery for pancreatic cancer.   "
167303|NCT00010075|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     older women who have metastatic breast cancer.   "
167304|NCT00010088|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, leucovorin, and     fluorouracil in treating patients who have locally advanced or metastatic cancer of the     pancreas or bile duct.   "
167305|NCT00010101|"     RATIONALE: Genetic studies may help in understanding the genetic processes involved in the     development of some types of cancer.      PURPOSE: Genetic study to understand how genes may be involved in the development of brain     tumors in young children.   "
167331|NCT00010465|"     The purpose of this study is to determine the efficacy of echinacea therapy and osteopathic     manipulation for the prevention of further ear infections in children with recurrent ear     infections (otitis media).   "
167312|NCT00010192|"     Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or     deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may     stimulate a person's white blood cells to kill cancer cells. Combining rituximab with     interleukin-2 may kill more cancer cells. Phase I trial to study the effectiveness of     rituximab plus interleukin-2 in treating patients who have hematologic cancer.   "
167313|NCT00010205|"     This phase I trial is studying the side effects and best dose of benzoylphenylurea in     treating patients with advanced cancer. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die   "
167314|NCT00010218|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of karenitecin in treating patients who     have relapsed or refractory non-small cell lung cancer   "
167316|NCT00010244|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known which regimen of radiation therapy is more effective for prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of     radiation therapy in treating patients who have localized prostate cancer.   "
167317|NCT00010257|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in     treating patients who have advanced thymoma.   "
167318|NCT00010270|"     RATIONALE: LMB-9 immunotoxin can locate tumor cells and kill them without harming normal     cells. This may be an effective treatment for advanced pancreatic, esophageal, stomach, colon     or rectal cancer.      PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients     who have advanced pancreatic, esophageal, stomach, colon, or rectal cancer.   "
167319|NCT00010283|"     RATIONALE: Beclomethasone may be an effective treatment for graft-versus-host disease.      PURPOSE: Phase I/II trial to study the effectiveness of beclomethasone in treating patients     who have graft-versus-host disease of the esophagus, stomach, small intestine, or colon.   "
167320|NCT00010309|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients     who have stage II, stage III, or stage IV melanoma.   "
167321|NCT00010322|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Toremifene may fight     breast cancer by blocking the uptake of estrogen by the tumor cells. Atamestane may fight     breast cancer by blocking the production of estrogen. It is not yet known if toremifene is     more effective with or without atamestane.      PURPOSE: Randomized phase III trial to compare the effectiveness of toremifene with or     without atamestane in treating postmenopausal women who have metastatic breast cancer.   "
167322|NCT00010335|"     OBJECTIVES: I. Determine the safety and long term complications of total body irradiation in     combination with cyclophosphamide, anti-thymocyte globulin, and autologous CD34-selected     peripheral blood stem cell (PBSC) transplantation in children with refractory autoimmune     disorders.      II. Determine the efficacy of this treatment regimen in these patients. III. Determine the     reconstitution of immunity after autologous CD34-selected PBSC transplantation in these     patients.      IV. Determine engraftment of autologous CD34-selected PBSC in these patients.   "
167323|NCT00010361|"     OBJECTIVES: I. Determine the safety of total body irradiation and fludarabine followed by     allogeneic peripheral blood stem cell or bone marrow transplantation in combination with     cyclosporine and mycophenolate mofetil for establishing mixed chimerism in patients with     inherited disorders.      II. Determine whether this regimen can establish mixed chimerism in these patients.      III. Determine whether mixed chimerism is sufficient to reverse disease symptoms in these     patients.      IV. Determine the safety of donor lymphocyte infusions to eliminate persistent disease in     these patients with mixed chimerism.   "
167324|NCT00010374|"     OBJECTIVES:      The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for     treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis. The     hypothesis being tested in the clinical trial is that laparoscopic stimulation of the     diaphragm at the motor point with intramuscular electrodes is safe and effective in providing     significant ventilatory support to individuals who are otherwise dependant on a mechanical     ventilator. Patients in our initial study group have all suffered from high-level spinal cord     injury and were full-time dependant on positive pressure mechanical ventilation prior to     inclusion.   "
167325|NCT00010387|"     OBJECTIVES:      I. Determine the response rate and 1-year event-free survival in patients with severe     autoimmune hematologic disease treated with high-dose cyclophosphamide.   "
167326|NCT00010400|"     OBJECTIVES:      I. Determine the induction of durable remission in patients with life-threatening systemic     lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide.      II. Determine the toxicity of this drug in these patients.   "
167327|NCT00010413|"     OBJECTIVES:      I. Determine the response rate and 1-year event-free survival of patients with refractory     pemphigus treated with high-dose cyclophosphamide.   "
167328|NCT00010426|"     OBJECTIVES: I. Determine the proportion of patients with cystinosis who experience a serious     adverse effect when treated with a new formulation of cysteamine hydrochloride for corneal     cystine accumulation.      II. Determine the proportion of patients with a reduction in corneal crystal density of 1.00     unit when treated with this regimen.   "
167329|NCT00010439|"     OBJECTIVES:      I. Determine the effects of alendronate sodium on skeletal remodeling and bone mineral     density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis.   "
167330|NCT00010452|"     OBJECTIVES:      I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic     lymphangioma.   "
178067|NCT00175838|"     The purpose of this trial is to see if Hydroxyurea + aspirin is a better treatment than     aspirin alone for Intermediate Risk Primary Thrombocythemia (PT) patients.   "
167332|NCT00010478|"     Although traditional Chinese medicine advocates the use of acupuncture not only to induce     analgesia but also to treat essential hypertension, acupuncture's postulated antihypertensive     efficacy in humans has not been subjected to rigorous Western scientific testing. Before     advocating acupuncture as an effective complementary/alternative medicine strategy for     essential hypertension, it is necessary to demonstrate that the beneficial effects of     acupuncture are scientifically robust, long-lasting, and explicable in terms of modern     scientific mechanisms. In spontaneously hypertensive rats, acupuncture-like electrical     stimulation of thinly myelinated (Group III) somatic afferents activates central endorphin     (naloxone-sensitive) pathways that elicit long-lasting decreases in sympathetic nerve     activity (SNA) and blood pressure. The ability to record SNA with microelectrodes in     conscious humans provides a new opportunity to test this novel mechanistic hypothesis in     patients undergoing electroacupuncture, a modification of the ancient technique that provides     a quantifiable and reproducible stimulus to human skeletal muscle afferents. Using a     randomized, double-blind placebo-controlled design, we will test the following major     hypotheses: Electroacupuncture produces a long-lasting reduction in SNA, thereby providing a     safe and effective complementary treatment of human hypertension. Given the enormous interest     in acupuncture by our lay public, but the paucity of Western scientific data about its     efficacy in cardiovascular disorders, our studies in normotensive and hypertensive humans     should provide a conceptual framework for deciding whether to accept or reject the large body     of Chinese (and Russian) literature advocating acupuncture as a safe and effective treatment     of essential hypertension and other cardiovascular disorders (such as heart failure, and     myocardial ischemia).   "
167333|NCT00010491|"     The objective of this study is to test alternative treatment strategies to reduce the     frequency of chronic diarrhea among HIV positive individuals. 60 percent of patients with HIV     disease in the U.S. will have diarrhea at some point in their illness. Although in general     many of the opportunistic infections (OI's) associated with HIV have decreased due to new     drug cocktails, many of these drugs, however, have diarrhea as a side effect. In Asian     countries, acupuncture (including moxibustion) has been widely used for the treatment of     various gastrointestinal (GI) disorders. However, there are no published studies that test     treatment protocols using acupuncture or moxibustion on patients with HIV experiencing     chronic diarrhea.   "
167334|NCT00010504|"     Fibromyalgia is the second most common rheumatic disorder, affecting approximately 8-10     million persons in the U.S., and is characterized by widespread musculoskeletal pain and soft     tissue tenderness upon examination. This study focuses on the use of acupuncture as a mode of     therapy for fibromyalgia. The issues under examination are: 1) the optimal duration of     treatment, 2) the independent and synergistic effects of needle placement and needle     stimulation, and 3) appropriate control strategies. The proposal utilizes a randomized,     blinded, sham-controlled design to achieve these aims. Subjects are randomly assigned to one     of four groups: 1)active site with stimulation, 2) active site, without stimulation, 3) sham     site with stimulation, and 4) sham site, without stimulation. All subjects will receive     acupuncture at escalating frequency, beginning at once per week and ending at 3 times per     week. This forced titration design allows for the detection of inter-subject differences in     responsiveness to acupuncture, as well as the factors which may predict responsiveness (or     lack thereof). Secondary goals of the study are to collect data on the mechanism, safety, and     cost-effectiveness of acupuncture in fibromyalgia, and to determine the optimal outcome     measures, for a full scale research clinical trial.   "
167335|NCT00010517|"     The current large randomized placebo-controlled trial is testing the ability of acupuncture     to treat major depression. The study is unique in that treatment effects will be from the     perspective of both Western psychiatry and Chinese medicine.   "
167336|NCT00010530|"     The purpose of this study is to evaluate the effects of meditation on older African Americans     with documented cardiovascular disease (CVD).   "
167337|NCT00010608|"     The purpose of this study is to evaluate the effectiveness of meditation in preventing of     atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women.   "
167338|NCT00010621|"     This study will determine whether selected complementary approaches to temporomandibular     joint (TMJ) pain management-acupuncture are as effective as usual care.   "
167339|NCT00010634|"     This study aims to assess selected naturopathic medicines for adult periodontitis and to     identify variables that influence successful outcomes when traditional and alternative     approaches to preventing and treating periodontal diseases are combined. Collaboration     between Kaiser Permanente, Oregon Health Science University and the National College of     Naturopathic Medicine provides an unsurpassed environment for such investigations.     Periodontitis is a major cause of tooth loss and negatively impacts systemic health. The     limitations of traditional periodontal treatment have compelled scientists and clinicians to     investigate new remedies, and naturopathic medicine holds several promising interventions.      Because they are used to improve elements of host resistance that are known to be important     in periodontal health and disease, three naturopathic medicines are potential adjuncts in     preventing and treating periodontitis. Connective tissue components are enzymatically     degraded in periodontitis. In naturopathy, Connective Tissue Nutrient Formula (CTNF)     (vitamins A, C and D, glucosamine sulfate, oligoproanthocyanindins, copper, zinc, manganese,     boron, silicon, magnesium, and calcium) is prescribed specifically to enhance the integrity     of key connective tissue elements and improve their resistance to degradation. Periodontitis     begins when permeability of the oral sulcular epithelium permits pathogenic bacterial     components to invade deeper periodontal connective tissues. In naturopathy, glutamine is     prescribed to reduce oral-intestinal epithelial membrane permeability. Chronic activation of     the hypothalamic-pituitary-adrenal (HPA) axis during the stress response, is a risk factor     for periodontitis. Adaptogenic herbs (AH) (Panax ginseng, Withania somnifera and     Eleutherococcus senticosus) are prescribed by naturopathic physicians to reverse the impact     of bacterial and psychosocial stressors. Because glutamine, CTNF and AH target     pathophysiologic mechanisms known to underline periodontitis, they are compelling candidates     in clinical and mechanistic investigations of complementary medicine approaches to the     management of periodontitis.      Kaiser Permanente adult periodontitis patients will serve as subjects and receive standard     periodontal treatment. Three of the four randomly assigned groups will also receive     supplements of glutamine, CTNF, or AH. We will determine the effects of these supplements on     clinical outcomes (attachment loss, pocket depths, indicators of inflammation, plaque     composition, need for periodontal surgery, acute periodontal problems, tooth loss). In     addition to completing the battery of self-report measures (stress, coping, quality of life),     study subjects will provide samples of blood, saliva, gingival cervicular fluid and bacterial     dental plaque. These samples will be examined as part of the Laboratory Core to identify     biologic and genetic characteristics that correlate with successful outcomes. Storage of     portions of the samples will allow future examination of additional variables as part of the     Developmental Projects carried out as the Craniofacial Complementary & Alternative Center is     established and Phase III trials are undertaken.   "
167340|NCT00010647|"     The purpose of this study is to estimate the cost-effectiveness of acupuncture and to     determine the long-term outcomes and health care utilization of people with osteoarthritis     (OA) of the knee.   "
167341|NCT00010686|"     The purpose of this study is to determine whether dietary phytoestrogens are an effective     alternative to postmenopausal exogenous estrogen replacement therapy in preventing bone loss.   "
167342|NCT00010699|"     The primary aim of the present study is to test the effect of alpha-tocopherol     supplementation on the progression of carotid atherosclerosis in patients with coronary     artery disease   "
167343|NCT00010712|"     This study will assess whether treatment with black cohosh is effective in reducing the     frequency and intensity of menopausal hot flashes. In addition, this study will determine     whether or not black cohosh reduces the frequency of other menopausal symptoms and improves     quality of life.   "
167344|NCT00010725|"     The purpose of this study is to compare an herbal supplement, nonfood-derived vitamins, and     placebo for the care of cardiovascular disease in high risk older African Americans.   "
167345|NCT00010738|"     To study the effects of Transcendental Meditation on Coronary Heart Disease   "
167346|NCT00010751|"     The object of this study is to determine if Reiki will improve glycemic control and cardiac     autonomic function diabetic patients with painful neuropathy.   "
167355|NCT00010881|"     The mission of the Oregon Center for Complementary and Alternative Medicine in Neurological     Disorders (ORCCAMIND) is to facilitate research and education on the effectiveness and     mechanisms of action of complementary and alternative medicine (CAM) therapies in the     treatment of neurological disorders. The integration of conventional medicine and CAM     communities is critical for the success of ORCCAMIND. Thus, ORCCAMIND is composed of six     institutions: Oregon Health Sciences University; National College of Naturopathic Medicine;     Western States Chiropractic College; Oregon College of Oriental Medicine; the Linus Pauling     Institute at Oregon State University; and the Portland Veterans Affairs Medical Center.      ORCCAMIND will initially focus on the use of CAM antioxidants and stress reduction as     treatments for neurodegenerative and demyelinating diseases because many of these diseases     have oxidative injury as a causative or contributory factor and several CAM approaches have     direct or indirect anti-oxidant effects. Through the Career Development Program the     Developmental Research Program and the activities of the Education and Information Core, we     will also foster and promote research into other CAM approaches for neurologic diseases that     extend beyond anti-oxidant therapies. ORCCAMIND will achieve its goals by carrying out 4     Research Projects and maintaining 4 Core facilities that integrate the research strengths of     conventional medicine and CAM practitioners and researchers. ORCCAMIND draws its strength     from the multi-institutional support and the quality of all its investigators. The     investigators join ORCCCAMIND with extensive experience with clinical trials, patient care,     externally funded basic and clinical neuroscience research, and training programs, including     federally-funded training grants. ORCCAMIND is a bold initiative that integrates basic and     clinical research scientists, conventional neurologists and CAM practitioners. It will     promote the exploration of new areas of CAM research and lead research on CAM therapies for     neurological disorders.   "
167356|NCT00010907|"     This research will determine whether the Chinese herbal medicine (NPI-028) can make a     significant contribution to the management of withdrawal and to follow-up treatment aimed at     preventing or managing relapse in both women and men alcoholics. The herbal preparation has     been used historically in the treatment of alcohol intoxication and is still prescribed in     China and Southeast Asia. Efficacy has been documented but awaits the application of current     research methods to establish efficacy, safety, and probable mechanisms of action.     Preclinical studies have been carried out in alcohol-preferring rats and vervet monkeys to     test efficacy in reducing voluntary alcohol intake, measure tolerance effects, and     toxicological affects. The proposed human trial will develop a placebo, establish quality     control, test methods of administration, and examine compliance issues. Following these     preliminary steps, a placebo controlled trial will be conducted using 160 subjects (80     subjects per treatment condition with 40 of each gender). Alcohol use, craving, health     status, psychological status, and at rates will be assessed using established measures that     are current in addiction research.   "
167704|NCT00022464|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have     metastatic melanoma.   "
167347|NCT00010764|"     Fibromyalgia (FM), one of the most common rheumatic conditions, is a condition of unknown     etiology characterized by widespread muscle pain and stiffness. Treatment is generally     unsatisfactory and most randomized, controlled treatment trials have been unable to     demonstrate a sustained effective intervention. A single, brief trial of electroacupuncture     demonstrated remarkable improvement among patients with FM, although lasting effects were not     evaluated. Nonetheless, the recently published National Institutes of Health Consensus     Development Statement on Acupuncture says musculoskeletal conditions such as fibromyalgia,     myofascial pain ....are conditions for which acupuncture may be beneficial. Thus, 96     patients will be recruited from a referral clinic for fatigue for a 12 week (24 treatments)     trial. These patients will be randomized into 3 control groups and 1 true acupuncture     group. The control groups will consist of a group receiving acupuncture treatment for an     unrelated condition (morning sickness), a group receiving needle insertion at non-channel,     non-point locations, and a true placebo group. This latter group will have acupuncture     needle guides tapped on the skin, then needles tapped. Thus, the specific aims of this study     are to 1) evaluate the short and long term efficacy and side effects of a 12 week randomized,     controlled trial of bi-weekly acupuncture in the treatment of FM; 2) establish the most     useful and scientifically sound control group for studies of acupuncture using FM as a model     for conditions characterized by chronic pain; 3) use both subjective and objective measures     of overall health and pain to determine the optimal time length of treatment; and 4) examine     the concordance of allopathic and acupuncture-based measures of outcome. For the purposes of     this study, subjects will be asked to complete a unique set of study measures at enrollment,     at 4, 8, and 12 weeks, and then again at 1 and 6 months post-treatment. Our primary outcomes     will be patient global assessment, subjective pain, and mean number of tender points.     Secondary outcomes will be pain threshold, analgesic use, physician global assessment,     functional status, sleep, psychological distress, and fatigue. Thus, this trial will have     both immediate and longer term implications for the scientific study of acupuncture as well     as the clinical care of the estimated 5 million patients with FM in the US. From a     methodological point of view, the proposed trial will establish the most appropriate methods     for choosing a control group should larger trials be conducted, suggest the optimum duration     of treatment, and evaluate the utility of diverse allopathic and alternative outcome     measures. Of equal importance, however, this research will test and potentially establish the     effectiveness of acupuncture.   "
167348|NCT00010777|"     The goal of this proposal is to evaluate the efficacy of a multiple component mind-body     (MCMB) therapy for fibromyalgia, both in short and long term outcomes. Preliminary work     suggests that FM patients do benefit from MCMB therapy (Singh et al 1998; Creamer et al     1998). This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB     intervention or a 12 week education/attention intervention. The primary aims of this study     are 1) to determine if a 12 week MCMB intervention improves short term (i.e. at 12 weeks)     outcomes in FM patients compared to an education/attention control group; and 2) to determine     if a 12 week MCMB intervention improves long term (i.e. at 24 weeks) outcomes in FM patients     compared to an education/attention control group.      A secondary aim of this project involves determining if there are patient characteristics     (i.e. disease severity and duration, demographics, psychological factors) associated with     improvements in short or long term outcomes as well as responses to the MCMB intervention.      The primary outcome measure will include physical functioning and pain as measured by the     Fibromyalgia Impact Questionnaire.   "
167349|NCT00010803|"     This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence     of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and     functional disability, reducing incidence of cardiovascular disease, and decreasing total     mortality.   "
167350|NCT00010816|"     Hepatitis C (HCV) is a chronic viral illness leading to progressive liver damage that has     emerged as a major public health issue in the United States. While HCV affects all population     groups, individuals with a history of intravenous drug use form the largest known risk group.     Between 90 and 100 percent of long term intravenous drug use will eventually test positive     for HCV, and there is substantial risk that even short term experimentation will result in     infection. Studies suggest that HCV will be the major cause of cirrhosis and liver cancer in     the next century. Currently, approved therapy includes recombinant interferons, which lead to     sustained remission in a minority of patients. However, patients abusing other substances,     including alcohol, are not eligible for interferon therapy. The need for investigation into     other potential therapies is clear. Current practice patterns in the Far East include the use     of traditional herbal remedies for symptomatic chronic viral hepatitis. This study is     intended to examine the effect of commonly used herbal remedies for the treatment of     symptomatic HCV.   "
167351|NCT00010829|"     This study will assess whether alternative, high phytoestrogen dietary interventions result     in favorable effects on biological parameters that have been associated with     hormone-dependent cancers, cardiovascular disease, and osteoporosis.   "
167352|NCT00010842|"     The purpose of this study is to compare the effectiveness of three antioxidant regimens in     treating the symptoms of multiple sclerosis (MS).   "
167353|NCT00010855|"     Analgesics and sedatives administered to control distress from minimally invasive surgical     procedures have limited effectiveness and serious side effects. Unabated distress not only     interferes with smooth progression of the ongoing procedure, but can elicit adverse responses     when patients need additional intervention. The long-term objective of this research is to     provide a safe and practical behavioral method for reducing cognitive and physiologic     distress associated with invasive procedures. Currently, this method should benefit at least     8 million patients annually in the US. Extrapolating the risk of intravenous conscious     sedation to the number of invasive procedures performed annually, we predict that 47,000     patients will suffer serious cardiorespiratory complications and 2,600 will die. These     numbers do not include effects of the psychological damage inflicted by poorly managed     procedure-related stress on patients' subsequent health behavior. This application sets out     to pursue three aims: 1) Prospectively determine the impact of self-hypnotic relaxation on     cognitive and physiologic distress during tumor embolizations; 2) Prospectively determine the     impact of self-hypnotic relaxation on distress in the postoperative period; 3) Determine the     impact of intraprocedural self-hypnotic relaxation on distress during subsequent tumor     embolization. We hypothesize that: 1) Self-hypnotic relaxation decreases cognitive and     physiologic distress during tumor embolizations. 2) Self-hypnotic relaxation decreases     cognitive and physiologic distress after tumor embolization when post-embolization ischemia     is expected to induce painful stimuli and systemic distress. 3) The beneficial effect of     self-hypnotic coping skills acquired during an invasive procedure carries over to the next     invasive procedure. Upon completion, the efficacy and durability of procedural administration     of nonpharmacologic analgesia will be known by a rigorous and practical assessment. The     relative performance of self-hypnotic relaxation will be quantified compared to standard care     and empathic controls in a well-characterized population of patients within the controlled     and monitored environment of a busy interventional radiology practice. Results from this     competing renewal will provide the next level of data needed for future study design to     determine broad clinical utility in a multicenter randomized controlled trial.   "
167354|NCT00010868|"     This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a     12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3     fatty acids vs. placebo in 120 bipolar I patients. All subjects entering the primary     prophylactic study will be euthymic or have only subsyndromal mood symptoms for at least 4     weeks. In addition, their concomitant medication (only lithium, divalproex, or no medication     will be permitted) will also be stable and at accepted therapeutic levels for at least 4     weeks. An 8-week lead-in phase will be available to subjects who do not meet the current     symptom and concomitant medication inclusion criteria (however, subjects must meet all of the     other inclusion/exclusion criteria): 1. 4 weeks of euthymic or subsyndromal mood. 2. Subjects     who are not already receiving lithium or divalproex. 3. Subjects receiving other psychotropic     medications.   "
167357|NCT00010920|"     Preventing dementia is an important goal for our aging population. This proposal is an     initial 42 months study of the effect of standardized ginkgo biloba extract (GBE) on     preventing or delaying cognitive decline in people age 85 years or older (the oldest old).     The study focuses on the oldest old who present a distinct advantage for primary prevention     studies because of their particularly high risk for developing mild cognitive impairment     (MCI), a precursor to dementia. Because this is a population that has previously been out of     the mainstream for use of alternative medicine, the safety of GBE in this age group will also     be tested in this study. The study is randomized, placebo controlled and double blind.     Approximately 200 elderly cognitively healthy subjects will be enrolled and followed for     detection of conversion to MCI. This pilot study is viewed as a necessary first step in order     to demonstrate that GBE, an alternative or complementary therapy, has a disease modifying     effect on the brain, distinct from a symptomatic effect. The study will test the feasibility     of the randomized start design, a trial design proposed as a method for discerning brain- or     disease- modifying from symptomatic effects. The magnitude of biological effect of the     treatments will also be assessed with volumetric quantitative MRI, a complementary means of     confirming whether there is a brain modifying effect (measured as a decrease in brain volume     loss with treatment). Peripheral markers of oxidation status will measure possible     anti-oxidant effects of GBE.   "
167358|NCT00010933|"     The purpose of this study is to investigate novel methods from CAM aimed at alleviating     chronic pain related to functional bowel disorders in children. To that end, two CAM     modalities will be investigated independently of each other, namely Guided Imagery and the     use of Chamomile teas as a form of botanical therapy.      Functional abdominal pain is defined as pain unrelated to an identifiable organic     gastrointestinal disorder. The two subcategories of functional bowel disorders examined by     this study will be RAP and IBS. The definition of RAP in children will follow Apley's classic     definition of paroxysmal abdominal pain occurring in children between the ages of 4 and 16     years that persists for more than three months, with a frequency of three or more episodes of     abdominal pain over a three month interval. A similar pattern of abdominal pain relieved by     defecation and/or associated with altered bowel habits and/or stool consistency will be     defined as IBS. Despite the above definitions, note that the typical frequency of pain     episodes associated with functional bowel disorders is at least three times per month.   "
167359|NCT00010946|"     The goal of this research is to determine the efficacy and safety of Traditional Chinese     Acupuncture (TCA) in patients with osteoarthritis of the knee. A three arm randomized     controlled trial (RCT) using sham TCA, true TCA, and an education/attention comparison group     with a total sample of 525 is proposed. Primary hypothesis to be tested is that patients     randomized to true TCA will have significantly more improvement in pain and function as     measured by the Womac Pain & Function Scales and patient global assessments than patients     randomized to the sham acupuncture and education/attention control groups.      Secondary aims of the study are to 1) determine if improvement with TCA differs between     patients below age 65 vs. those aged 65 and above, 2) to determine if improvement with TCA     differs by racial/ethnic group (ie., Caucasian, Black, Hispanic), and 3) to determine if     improvement with TCA differs by stage of radiographic severity of knee OA at baseline (KL     grade 2, 3 or 4)   "
167360|NCT00010959|"     This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense     (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose     of one botanical preparation. The observation period will be one week. Drug toxicity,     absorption, distribution, metabolism and elimination data will be collected, and dosages to     be utilized in a Phase II clinical trial will be determined.   "
167361|NCT00010972|"     This study is testing the safety and effectiveness of acupuncture in controlling pain related     to the removal of partially impacted mandibular third molars. Acupuncture is the Chinese art     of healing by inserting needles into the skin.      Participants ages 18 - 40 are given an initial x-ray to determine if one lower molar is     partially bony impacted. Eligible participants will then undergo standard oral surgery to     remove the impacted molar. A local anesthetic will be used prior to surgery. Directly after     surgery the participant will be assigned to one of three groups. Participants will not be     able to select which group they are assigned. Participants will receive either real or sham     (fake) acupuncture as a treatment for post-extraction pain. After the initial acupuncture     treatment, participants are required to remain for six hours at the dental site to be     monitored. If a participants discomfort is measured as moderate or higher then a second     acupuncture treatment will be administered. All participants will be administered     questionnaires during the day of surgery. Participants will also be required to complete two     diaries during the seven days following surgery. On the seventh day, participants return to     have stitches removed and hand in completed diaries.   "
167376|NCT00011167|"     To determine whether retinal arteriolar changes (generalized narrowing, focal narrowing and     arterio-venous nicking) and retinopathy were associated with 10-year stroke-and ischemic     heart disease-related mortality.   "
167377|NCT00011180|"     To evaluate the trends in the incidence of venous thromboembolism, to determine the risk     factors for venous thromboembolism in patients with medical and surgical illness, and to     evaluate the efficacy of the anticoagulant therapy in reducing venous thromboembolism.   "
167406|NCT00017576|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Calcitriol may help carboplatin kill more cancer cells by making     tumor cells more sensitive to the drug.      PURPOSE: Phase II trial to study the effectiveness of carboplatin plus calcitriol in treating     patients who have prostate cancer that has not responded to hormone therapy.   "
167407|NCT00017589|"     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and     either kill them or deliver tumor-killing substances to them without harming normal cells.     Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more     sensitive to the drug.      PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab     ozogamicin in treating older patients who have relapsed acute myeloid leukemia.   "
167629|NCT00030108|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in     treating young patients with relapsed or refractory solid tumors or leukemia.   "
167362|NCT00010985|"     This study compares two approaches to the management of acute low back pain: usual care     (standard benefit) vs. the choice of: usual care, chiropractic, acupuncture or massage     therapy (expanded benefit). 480 subjects with uncomplicated, acute low back pain will be     recruited from a health maintenance organization, and randomized to either usual care (n=160)     or choice of expanded benefits (n=320). Patients' preferences for individual therapies and     expectations of improvement will be measured at baseline and throughout the study. Subjects     randomized to the expanded benefits arm who choose chiropractic, acupuncture or massage will     receive up to 10 treatments over a five-week period. Additional treatments will be available     after the fifth week but will require a copayment. Treatments will be provided by licensed     providers who have met strict credentialing criteria. Chiropractic, acupuncture or massage     treatments will begin within 48 hours. Chiropractic, acupuncture and massage therapy scope of     practice guidelines for the treatment of acute low back pain have been developed as have     detailed data tracking procedures to be used at each patient visit. Symptom relief,     functional status, restricted activity days, use of health care, and patient and provider     satisfaction will be assessed at 2, 5,12, 26 and 52 weeks after initiation of treatment.     Primary outcomes will include: 1) change in symptoms; 2) change in functional status; 3)     patient satisfaction; and 4) total utilization of services associated with care for low back     pain. Medical records and the HMO's cost management information system will identify use of     services. It is hypothesized that patients offered their choice of expanded benefits will     experience a more rapid improvement in symptoms, a faster return to baseline functional     status, a decrease in utilization of conventional medical services, and will be more     satisfied with their care. The study is a direct examination of the effectiveness of an     insurance eligibility intervention, not a test of the efficacy of specific, non-allopathic     treatment regimens. The results of this study will provide valuable information to     clinicians, patients and third party payers on the relative benefits and costs of an     expanded benefits treatment option which incorporates chiropractic, acupuncture and massage     services for low back pain.   "
167363|NCT00010998|"     Changes in visual attention are common among elders and people with multiple sclerosis. The     visual attention changes contribute to difficulty with day to day functioning including     falls, driving and even finding one's keys on the kitchen counter as well as contributing to     deficits in other cognitive domains. Yoga emphasizes the ability to focus attention and there     is some evidence that the practice of yoga may improve one's cognitive abilities.     Additionally, yoga practice may improve cognitive function through other non-specific means     such as improved mood, decreased stress or declines in oxidative injury. We propose a     randomized, controlled 6 month phase II trial of yoga in two separate cohorts: healthy elders     and subjects with mild multiple sclerosis. We will determine if yoga intervention produces     improvements on a broad attentional battery that especially emphasizes attentional control.     To further understand the reported beneficial effect of yoga on its practitioners, we will     also determine if there is a positive impact on measures directly related to yoga practice     (flexibility and balance) as well as mood, quality of life and oxidative injury markers. The     yoga intervention consists of a Hatha yoga class meeting twice per week. The class is taught     by experienced yoga teachers who are supervised by a nationally known yoga instructor. There     are two control groups. An exercise group will have a structured walking program prescribed     by a certified Health and Fitness Instructor and Personal Trainer. The program will attempt     to match the Hatha yoga class for metabolic demand. The second control group will be assigned     to a 6 month waiting list. The outcome measures are assessed at baseline and after the 6     month period. The primary outcome measures are alertness (quantitative EEG and self-rated     scale), ability to focus attention (Stroop) and ability to shift attention (extradimensional     set shifting task). Secondary attention outcome measures include the ability to sustain     attention (decrement in reaction time) and ability to divide attention (Useful Field of     View). Other secondary outcome measures include flexibility, balance, mood, quality of life,     fatigue (in MS cohort) and decreased markers of lipid, protein, and DNA oxidative injury.   "
167364|NCT00011011|"     Long-term control of HIV depends on improvement in an individual's immune system. The purpose     of this study is to see if either stopping anti-HIV drugs for short periods of time and/or     adding a vaccine to the anti-HIV drugs being taken will help to better control HIV infection.     The study will test whether these treatment approaches are safe. The HIV vaccine in this     study has been tested in people who did not have HIV infection and improved the way their     immune system worked. This study will evaluate whether these same immune system changes     happen in people with HIV, and, if such changes do occur, assess whether these changes help     to improve control of HIV in these patients.   "
167365|NCT00011024|"     We propose to identify patients and families for inclusion in pilot studies of the three     modalities. Patients and their families will be asked to participate in these studies.      Our research group has done some preliminary work with the modality of hypnotherapy, but has     no experience to date with the other two modalities. The idea to try relaxation techniques     was generated by the observation that there is great variation in the degree to spasticity at     different times in the same patient with CP. When queried, mothers responded that they were     able to get their child to relax and decrease the tension in their muscles by stroking,     talking softly, and/or by playing certain types of music. The availability of hypnosis and     training in self-hypnosis was presented to several families of our patients. Their     understanding and acceptance of this alternate therapy was gratifying. The results of this     therapy have been promising and have encouraged us to proceed with this modality and to     consider making other nonconventional modalities available to our patients.      We hypothesize that at least one of the two modalities will be accepted readily by patients     with CP and their families, and with their acceptance compliance with the method chosen will     be at levels of 80 percent or more.   "
167366|NCT00011037|"     The purpose of this study is to test how the body's immune system responds to the vaccine     ALVAC-HIV vCP1452 and to determine if the vaccine is safe when given alone and with MN     rgp120.      HIV infection and AIDS have no cure, in spite of recent advances in anti-HIV drugs. Many     worldwide populations cannot afford the antiviral treatments for infected people. HIV     vaccines offer hope for disease prevention. In this trial, 2 experimental HIV vaccines called     ALVAC vCP1452 and MN rgp120 will be given to volunteers in Haiti, Brazil, Peru, and Trinidad     and Tobago. The study will determine how volunteers' immune systems respond to the vaccines.     (This protocol has been changed by adding new international sites.)   "
167367|NCT00011050|"     The purpose of this study is to determine whether laboratory storage of samples affects the     amount of lactate over 3 years.      Lactate is a natural substance normally present in the body. Lactate levels can go up for     many different reasons, including treatment with nucleotide reverse transcriptase inhibitor     drugs. This study will help researchers know if stored blood samples can be used to test     lactate levels.   "
167378|NCT00011193|"     To investigate the effects of different amounts of exercise on both cardiorespiratory fitness     and risk factors for cardiovascular disease in sedentary, overweight, mildly hypertensive,     but healthy, postmenopausal women aged 45 to 75 years.   "
167379|NCT00011206|"     To extend mortality followup through 25 years for two cohorts of men in the Multiple Risk     Factor intervention Trial (MRFIT): the 361,662 men screened and the 12,866 men randomized,     and to pursue the general aim of elucidating unresolved research issues on the epidemiology,     natural history, etiology, prevention, and control of major chronic diseases, particularly     cardiovascular and neoplastic diseases and diabetes.   "
167404|NCT00017550|"     RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be     effective treatment for myelodysplastic syndrome. It is not yet known whether     immunosuppressive therapy is more effective than supportive care in treating myelodysplastic     syndrome.      PURPOSE: Randomized phase II trial to compare the effectiveness of antithymocyte globulin     with that of supportive care in treating patients who have myelodysplastic syndrome.   "
167368|NCT00011063|"     This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination     of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and     overall feeling of well being. Since this product is considered a food supplement and not a     drug, it is not subject to the rigorous pre-market testing required for prescription and     over-the-counter (OTC) drugs. As a result, information has not been collected on possible     interactions between ginkgo biloba and other medications. This study will look at how ginkgo     biloba affects the elimination of phenytoin-a medication used to treat patients with     seizures.      Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study.     Candidates will provide a medical history and undergo a physical examination and routine     blood tests. Women of childbearing age must use a reliable form of birth control other than     oral contraceptives (the pill).      For at least 2 weeks before the study and throughout its duration, study participants may not     have any of the following: 1) medications that can affect platelet function (e.g., aspirin,     Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit     juice; and 4) all medications except those given by study personnel.      On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty     stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat     breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at     0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on     this first study day is collected through a catheter (small plastic tube) placed in a vein to     avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and     then returns to the clinic for the remaining blood draws, which are taken by direct     needlestick.      When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center     provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and     8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of     phenytoin as described above and repeat the blood sampling procedure. Subjects continue     taking ginkgo during this second phenytoin study.   "
167369|NCT00011076|"     This study will examine the effectiveness of the drug pirfenidone (Deskar) in improving heart     function in patients with hypertrophic cardiomyopathy (HCM). Stiffening of the heart muscle     in patients with HCM impairs the heart's ability to relax and thus fill and empty properly.     This can lead to heart failure, breathlessness and excessive fatigue. The heart's inability     to relax may be due to scarring, or fibrosis, in the muscle wall. This study will test     whether pirfenidone can reduce fibrosis, improve heart relaxation and reduce abnormal heart     rhythms.      Men and women 20 to 75 years old with HCM may be eligible for this study. Participants will     undergo a physical examination, blood tests, and other tests and procedures, described below,     to assess heart function. When the tests are completed, patients will be randomly assigned to     one of two treatment groups. One group will take a pirfenidone capsule and the other will     take a placebo (a look-alike pill with no active ingredient) twice a day with meals for 6     months. For the pirfenidone group, the dose of drug will be increased gradually from 400 to     800 milligrams. At the end of 6 months, all patients will repeat the physical examination and     heart tests that were done before starting medication. These include:        -  Electrocardiogram (ECG) - electrodes are attached to the heart to record the heart's          electrical activity, providing information on the heartbeat.        -  Echocardiogram - a probe held against the chest wall uses sound waves to produce images          of the heart, providing information on the function of the heart chambers.        -  24-hour Holter monitor - a 24-hour recording of the electrical activity of the heart          monitors for abnormal heartbeats or conduction abnormalities.        -  Magnetic resonance imaging (MRI) - Radiowaves and a strong magnetic field are used to          produce images of the heart, providing information on the thickness and movement of the          heart muscle.        -  Radionuclide angiogram - a radioactive tracer is injected into a vein and a special          camera is used to scan the heart, providing information on the beating motion of the          heart. Scans are obtained at rest and after exercise.        -  Cardiac (heart) catheterization - a catheter (thin plastic tube) is inserted into a          blood vessel in the groin and advanced to the heart to record pressures and take          pictures inside the heart.        -  Electrophysiology study - a catheter is inserted into a blood vessel in the groin and          advanced to the heart to record electrical activity, providing information on abnormal          heart rhythms. This procedure is done at the time of the heart catheterization.        -  Cardiac biopsy - a catheter is inserted into a blood vessel in the groin and advanced to          the heart to remove a small sample of heart muscle for microscopic examination. This          procedure is done at the end of the heart catheterization.   "
167370|NCT00011089|"     The purpose of this study is to make tenofovir disoproxil fumarate (DF) available to     HIV-infected patients who have failed other anti-HIV drug combinations, who have few     treatment choices available, and whose disease may get worse. This study will allow patients     to obtain tenofovir DF before it is approved for marketing.   "
167371|NCT00011102|"     The purpose of this study is to test methods for preventing weight gain in normal-weight and     overweight women aged 25 through 44. Participants will complete brief questionnaires about     their health, eating and exercise habits, and use of weight control strategies. They will     then be randomly assigned to 1 of 3 treatment conditions. All 3 treatments receive     information on the importance of maintaining a healthy body weight, the components of a     healthy diet, and ways to increase activity levels. The 3 treatment differ in how this     information is delivered. At 12, 24 and 36 months after enrolling in the study, participants     will attend assessment sessions. They will complete questionnaires and have body weight     measured.   "
167372|NCT00011115|"     This study tests the effects of emphasizing different motivations for wanting to lose weight     on weight loss maintenance in women. At the start of the study, participants will be weighed     and will complete questionnaires about their health, weight history, eating and exercise     habits, body satisfaction and mood. Participants will then be randomly assigned to 1 of 4     treatments. Participants in all 4 groups will receive information on topics related to eating     and exercise, and will receive calorie and fat intake goals, and exercise goals. The 4     treatments will differ in the emphasis given to various reasons for wanting to lose weight.     At 6, 12 and 18 months after enrollment, participants will again have weights measured and     fill out questionnaires.   "
167373|NCT00011128|"     The purpose of this study is to test another way to control the amount of HIV in the blood     (viral load).      Studies show that stopping all anti-HIV drugs for a time before switching to new anti-HIV     drugs may improve the response in some individuals who are failing treatment. Other studies     suggest a benefit if drug-resistance tests are used in selecting a new anti-HIV drug     treatment. This study tests the effect of stopping anti-HIV drugs for a time before switching     to anti-HIV drugs selected using drug-resistance test results.   "
167374|NCT00011141|"     The etiology of immune-mediated diabetes mellitus (IMD) remains unclear. However, previous     studies indicate that autoimmunity may be a result of dysfunction of natural killer T cells     (NK-T cells). Newly diagnoses patients with IMD have been shown in our laboratory to have     significantly lower NK-T cells than normal controls. Other studies have shown that oral     administration of lactobacillus can boost NK-T cell activity in children with HIV without     side effects. Our objective is to evaluate the effect of lactobacillus administration on NK-T     cell activity in patients with IMD   "
167375|NCT00011154|"     Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a fatal     neurodegenerative disease that poses a significant burden for affected individuals and their     family members. The principal objective of this epidemiologic study is to identify     environmental and genetic risk factors for ALS. Of primary interest is whether environmental     chemicals such as heavy metals, pesticides and organic solvents contribute to the cause of     ALS. We also aim to identify genetic factors that contribute to the risk of ALS because     individuals with certain genetic traits may be unable to protect against the toxic effects of     chemical exposure. Other factors that may protect against the development of ALS, such as     dietary antioxidants, are also under investigation. If modifiable factors affecting the risk     for ALS could be identified, interventions to delay or even prevent the development of ALS     could be developed.   "
167380|NCT00011245|"     The goal of this study is to establish the mechanism(s) of progression of primarily spinal     syringomyelia (PSS). Our preliminary study of syringomyelia emphasized syringomyelia     associated with craniocervical junction abnormalities (CCJAS), such as the Chiari I     malformation. This new protocol will expand the scope of our investigation to include     primarily spinal syringomyelia (PSS), which is defined as syringomyelia not associated with     craniocervical junction abnormalities (CCJAS). Etiologies of primarily spinal syringomyelia     include 1) intradural scarring which is post-traumatic, post-inflammatory, or post-operative,     2) intradural-extramedullary masses such as arachnoid cysts or meningiomas, and 3)     extramedullary-extradural spinal lesions such as cervical spondylosis or spinal deformity.      Our hypothesis is the following: Primarily spinal syringomyelia (PSS), results from     obstruction of cerebrospinal fluid (CSF) flow within the spinal subarachnoid space; this     obstruction affects spinal CSF dynamics because the spinal subarachnoid space accepts the     fluid that is displaced from the intracranial subarachnoid space as the brain expands during     cardiac systole; in the case of primarily spinal syringomyelia (PSS), a subarachnoid block     effectively shortens the spinal subarachnoid space, reducing CSF compliance and the capacity     of the spinal theca to dampen the subarachnoid CSF pressure waves produced by the brain     expansion during cardiac systole; the exaggerated spinal subarachnoid pressure waves occur     with every heartbeat and act on the spinal cord above the block to drive CSF into the spinal     cord and create a syrinx. Presyringomyelia, a recently described state of spinal cord edema     associated with progressive myelopathy and obstruction in CSF flow, is a precursor stage to     syringomyelia that is consistent with this hypothesis. Because of the importance of this     condition to the pathophysiology of syringomyelia, we will also study patients with     presyringomyelia in this protocol. After a syrinx is formed, the enlarged subarachnoid     pressure waves compress the external surface of the spinal cord, propel the syrinx fluid, and     promote syrinx progression.      Many neurosurgeons at prominent academic centers routinely use syrinx shunts to treat     primarily spinal syringomyelia. This study should provide data that a surgical procedure that     opens the spinal subarachnoid space corrects the underlying pathophysiology and resolves the     syrinx and that invasion of the spinal cord is unnecessary.   "
167381|NCT00011258|"     Atherosclerosis of the carotid arteries is a common cause of stroke. The prevalence and     progression of carotid atherosclerosis are believed to be influenced by genetically inherited     variations in lipoprotein metabolism. This study investigates the specific role of     paraoxonase, an enzyme thought to detoxify atherogenic oxidized low-density lipoprotein. This     study compares veterans who have significant carotid atherosclerosis on ultrasound     examination with controls without carotid atherosclerosis. Both paraoxonase activity and     genotype will be determined and compared between groups. The results may eventually make it     possible to screen for a paraoxonase allele that confers high risk of atherosclerosis, and to     diminish the risk by early treatment.   "
167382|NCT00011284|"     White blood cells can cause liver damage if they inappropriately accumulate in the liver in     large numbers. Such an event can occur if an individual's blood is exposed to endotoxin, a     substance released from the cell walls of many species of bacteria. The purpose of this study     is to isolate neutrophils, an important white blood cell, from the blood of normal     volunteers, and put them in tissue culture with isolated liver cells. The experiments will     determine how endotoxin can increase the ability of neutrophils to damage liver cells. All     studies supported by this grant will be done with isolated cells in tissue culture. This     experimental model will reveal possible mechanisms that can in the future be evaluated in     human diseases such as bacterial sepsis.   "
167383|NCT00011297|"     This study will evaluate a safe and useful medication for outpatient detoxification that is     as effective as benzodiazepines in the short-term, and more effective in the protracted     withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine,     lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.   "
167384|NCT00011310|"     The aim of this study is to assess cardiac rate and respiratory responses and rhythm after     workplace exposure to combustion particulates. A repeated measurement study is being     performed on acute boilermakers (apprentices and journeymen). A stratified analysis is then     done on those with and without chronic bronchitis, after adjustment for relevant covariates.   "
167385|NCT00011323|"     The goals of this project are to establish a new cohort of male veterans and describe     associations between potential risk factors and baseline bone mineral density (BMD) as well     as rates of BMD loss.   "
167386|NCT00011336|"     This study is using a standardized method to assess respiratory function in SCI in order to     determine the association between level of SCI with chronic respiratory symptoms, measures of     pulmonary function, and respiratory illness, both cross-sectionally and longitudinally.   "
167387|NCT00011349|"     Environmental factors such as diet and cigarette smoking may play a role in predicting the     progression of early stage prostate cancer to advance disease. The goal of this project is to     establish an observational cohort of patients with early stage prostate cancer who elect not     to undergo radical prostatectomy or radiation therapy to evaluate risk factors which predict     the transformation of early stage to clinically aggressive disease.   "
167388|NCT00011362|"     Infants who are on breathing support are often treated with steroids (dexamethasone);     however, the best timing of therapy is not known. This trial looked at the benefits and     hazards of starting dexamethasone therapy at two weeks of age and four weeks of age in     premature infants.   "
167389|NCT00011375|"     This study will evaluate the safety, tolerability, and effect of the drug Rolipram on     multiple sclerosis (MS). It will examine whether Rolipram can dampen the part of the immune     response believed to lead to MS and reduce disease activity.      Patient with multiple sclerosis who are between the ages of 18 and 65 may be eligible for     this study. Candidates will be screened with a complete neurological and medical evaluation.     Participants will complete three study phases-baseline, treatment and follow-up, as follows:      Baseline (3 months) - Approximately four magnetic resonance imaging (MRI) scans will be     obtained to assess MS activity. Participants with MS activity above a certain level will     continue with the treatment phase.      Treatment (8 months) - Patients will take Rolipram tablets in increasing doses every 2 to 3     days for the first month of this phase until their individual maximum tolerated dose is     established. Dosing will continue at that level for the rest of the treatment phase. Dosing     is in the morning, midday and evening. Patients will be seen monthly in the clinic for     examination and MRI scans.      Follow-up - Participants will have monthly exams and MRIs for 3 months following the     treatment phase, after which their participation in the study ends.      Patients' monthly visits during treatment and follow-up include a neurological examination to     assess disease status; MRI to assess brain changes; and blood and urine collection to monitor     liver, kidney and other functions. In addition, a lumbar puncture (spinal tap) is done during     the last month of the baseline phase and one month after treatment ends to study changes in     the spinal fluid surrounding the brain and spinal cord, and leukapheresis is done once during     the last month of the baseline phase and once during the last month of treatment to collect     white blood cells for study. These procedures involve the following:      MRI uses a strong magnetic field and radio waves instead of X-rays to produce images showing     structural and chemical changes in tissues. The patient lies on a table in a narrow cylinder     (the scanner) containing a magnetic field and images are taken. A contrast agent called     gadolinium is injected into a vein during the last set of images to help identify new     lesions. Magnetic resonance spectroscopy, which is similar to MRI, is also done once during     the baseline phase, at 4 months and at 8 months to measure brain chemicals. For the spinal     tap, a local anesthetic is given and a needle is inserted in the space between the bones     (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.     For leukapheresis, whole blood is collected through a needle placed in an arm vein. The blood     circulates through a machine that separates it into its components. The white cells are     removed and the red cells, platelets and plasma are returned to the body through a second     needle placed in the other arm.      Patients may also have studies to measure levels of Rolipram in the blood. These are done on     study days 1 and 29 and at months 2, 4, and 6. For days 1 and 29, a catheter is placed in an     arm vein and 4 ml. of blood is drawn immediately before the morning dose and at several     intervals from 20 minutes to 6 hours after the dose. For the other tests, a single 4-ml     sample is collected before the noon dose.   "
167390|NCT00011388|"     This project is examining the reproductive effects of exposure to certain compounds that are     suspected to act on the endocrine system, e.g. they may act like or interfere with hormones     such as estrogen. The study is being conducted among Laotian women, as it is suspected that     they may have higher exposures to the compounds of interest (pesticides and PCBs) from their     homeland and from consumption of fish caught in the San Francisco Bay. Fifty Laotian     immigrants were recruited by community workers to collect urine daily during 3 menstrual     cycles for measurement of steroid hormones (estrogen and progesterone). Additionally, they     provided a blood sample to measure exposure levels, and completed 2 interviews in their     native language. These measured levels, as well as the self-reported data on a number of     factors including fish consumption, will be examined for possible effects on hormone levels     and menstrual function.   "
167402|NCT00011570|"     The investigators will continue their work with implanted stimulators to improve bladder and     bowel function. Electrical stimulation produces simultaneous contraction of sphincters with     the target organs, making emptying difficult. By optimizing electrode placement, employing a     new electrode design and waveform choice, it is hoped to improve the 50% of subjects able to     defecate with existing approaches. This is part of a multi-center study with multiple support     sources, including Rehab R&D, PVA and a commercial stimulator company.   "
167403|NCT00017537|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have metastatic or recurrent cancer.   "
167589|NCT00029523|"     The purpose of this study is to find out how well an experimental drug called DepoCyt works     for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal     cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine).     Cytarabine has been used for many years to treat cancer.   "
167391|NCT00011414|"     This study will evaluate the tolerance and effects of tariquidar, given in combination with     one of three anticancer drugs, for treating solid tumors. Tariquidar works by blocking a pump     on a cancer cell. The pump on a cell that prevents anticancer drugs from accumulating is     called Pgp (P-glycoprotein). Researchers hope to see whether cancer-fighting drugs can stay     in the cells longer.      Patients ages 2 to 18 who have solid tumors may be eligible for this study. Tariquidar is     infused intravenously (IV) over 30 minutes, given every 21 to 28 days, with one drug that     kills cancer cells. Patients are examined by a doctor at least once weekly during treatment     and will have routine blood tests twice weekly. They will receive one of the following drugs     with tariquidar: doxorubicin (Adriamycin ), vinorelbine (Navelbine ), or docetaxel (Taxotere     ). At the first treatment cycle only, there is a baseline Sestamibi scan before treatment and     a second one immediately after drug administration. If patients receive tariquidar with     doxorubicin, tariquidar is given alone. Then 48 to 72 hours later, the second dose is given,     followed by doxorubicin by IV over 15 minutes. Dexrazoxane, which decreases damaging effects     of doxorubicin on the heart, is also given by IV over 15 minutes. Granulocyte colony     stimulating factor (G-CSF) is injected daily 48 hours after doxorubicin, to alleviate     doxorubicin s effect on white blood cells. If patients receive tariquidar with vinorelbine,     tariquidar is given alone. Then 48 to 72 hours later, the second dose is given, immediately     followed by vinorelbine by IV over 10 minutes; then 1 week later, tariquidar is again given,     immediately followed by vinorelbine by IV for 10 minutes. G-CSF is given daily. If patients     receive tariquidar with docetaxel, tariquidar is given alone. Then 48 to 72 hours later, the     second dose is given, followed by docetaxel by IV over 60 minutes. Drugs to prevent allergic     reactions are given before and after each docetaxel dose. G-CSF is given daily.      Tariquidar may affect blood pressure during infusion, and there can be reduction of normal     blood cells, gastrointestinal problems, and allergic reactions. The radioactive Sestamibi can     cause headache, chest pain, and nausea. Radiation used in this study has been approved as     involving a slightly greater than minimal risk for adults and an acceptable risk for     children. This radiation is considered necessary to obtain information desired. One possible     effect is a slight increase in the risk of cancer.      This study may or may not have a direct benefit for participants. However, knowledge gained     may benefit people with cancer in the future.   "
167392|NCT00011440|"     This study is designed to investigate whether exposure to particulate air pollution increases     the allergic response to allergens. Research studies suggest that symptoms in individuals     with allergies may be aggravated by exposure to particulate air pollution. We sought to     experimental determine this by exposing human volunteers to combustion particles, a component     of air pollution, and then challenge them with an allergen such as ragweed or oak tree     pollen. Using biological tests we can measure whether the allergen response is magnified by     prior particulate exposure.   "
167393|NCT00011453|"     We are investigating the role of an enzyme (NQO1) in protection against the bone marrow     toxicity of the occupational and environmental toxicant benzene. All of the proposed studies     involve use of human bone marrow cells in-vitro to define mechanisms of NQO1-mediated     protection. Cells are obtained from healthy volunteers and protocols have undergone IRB     review and approval.   "
167394|NCT00011466|"     Specific nutrient deficiencies have been described in children with ADHD including zinc,     magnesium, calcium, and essential fatty acids. In addition, children with ADHD have been     noted to behave and concentrate better in some studies when the ratio of protein compared     with carbohydrate in their diets was increased, however, this was anecdotal information noted     from studies designed to study other factors, so its not clear if the increased protein is     actually the cause of the improved behavior. In our clinical practice, we have noted a high     incidence of what appears to be carbohydrate craving among children with ADHD, which can     put children at risk for obesity, diabetes type II, and additional dysregulation of mood and     concentration. Carbohydrate craving is a well-documented phenomenon in adults, particularly     those with certain patterns of obesity, mood disorders, or those undergoing smoking cessation     programs. It has not been studied in children, however. Thus, this initial study was designed     to determine 1) whether or not children with ADHD have different patterns of nutrient intake     compared with children in the same family and children in families without a child with ADHD,     2) if the described nutrient deficiencies are due to decreased intake, and 3) whether there     is an increased occurrence of carbohydrate craving, based on parents' perceptions, eating     patterns, and actual intake, among children (or certain subgroups of children) with ADHD. The     information gained from this study will be used to design additional studies to test     causative hypotheses and intervention strategies.   "
167395|NCT00011479|"     The purpose of this study is to measure blood levels of abacavir in children and adolescents     over a period of time following a single dose so that a dosage for adolescents can be     determined.      Little is known about how abacavir is cleared by the body in adolescents. It has been shown     that young children require a higher abacavir dose based on weight than adults. Older     children, or adolescents, may not require as high a dose. This study may provide information     as to whether the children's dose or the adult dose is better for HIV-infected adolescents.   "
167396|NCT00011492|"     This protocol offers evaluation and, in some cases, standard treatment for patients with head     and neck cancer in NIDCD s Head and Neck Surgery Branch (HNSB). The study is not designed to     test new treatments. Its purpose is twofold: 1) to identify patients who may be eligible for     investigational protocols. (Participants in this protocol will not be required to join a     research study; the decision will be voluntary.); and 2) to provide standard treatment for     patients who are not eligible for an investigational study but who present an education and     training opportunity for HNSB physicians and clinical fellows.      Patients with head and neck cancer may enroll in this study. Participants may undergo various     tests, described below, to determine their eligibility for participation in a specific     clinical trial. Other tests may also be required, depending on the protocol or treatment for     which the patient is being considered:        -  Blood tests About 3 to 5 tablespoons of blood will be drawn for routine tests, HLA          typing and hepatitis and HIV screening.        -  Magnetic resonance imaging (MRI) This imaging procedure uses a powerful magnetic field          to produce pictures of parts of the body in small section views. The test does not use          radiation and may be done with or without a contrast dye material.        -  Computerized tomography (CT) This procedure uses x-rays to produces three-dimensional          images of body organs in small section views. A contrast dye may or may not be used.        -  Positron emission tomography (PET) PET scans allow the doctor to see the activity of          cells in specific body tissues. It requires injection of a radioactive material that          attaches to a sugar fluid. The fluid goes to very active cells, such as cancer cells,          revealing tumors.        -  Pulmonary function tests These tests use a machine the patient breathes into to measure          the volume of air the patient can move in and out of the lungs.        -  Arteriogram, or angiogram The anatomy of the blood vessels can be seen using this          procedure, which involves placing a small catheter (plastic tube) into an artery and          injecting a contrast solution. Special X-rays are then taken to show the blood vessels.        -  Endoscopy This procedure is done to evaluate the mouth and throat. A tube with a light          on the end and special fibers is inserted down the throat to allow the surgeon to          examine the throat and, if needed, biopsy a piece of tissue for microscopic study. The          test is usually done under general anesthesia in the operating room.        -  Biopsy A piece of tissue or tumor is removed for examination under the microscope. When          a biopsy is done in the neck area, a small amount of anesthetic is injected into the          area of the biopsy. The biopsy may be done with 1) a small needle to pull out some          tissue, 2) a cookie-cutter-like instrument to punch out a small piece of tissue, or 3) a          small knife to cut out a piece of tissue. A knife biopsy may be done in the operating          room or the clinic depending on the location of the biopsy and precautions required.      When the tests are done, the physician will discuss the results with the patient. Patients     eligible for a research study will be offered participation. For those not eligible for a     study, other therapies will be discussed and the patient will return to the care of his or     her primary physician. In special circumstances, patients may be offered standard     non-experimental treatment at NIH.   "
167397|NCT00011505|"     This study will provide information needed to develop more effective treatments for patients     with Diamond-Blackfan anemia (DBA). Current treatments include steroids, such as prednisone,     and blood transfusions. These treatments have potential long-term risk and side effects,     including osteoporosis and impaired growth from steroids or iron overload from transfusions.     In addition, as patients reach adulthood, they can develop acute leukemia or bone marrow     failure. The only cure for DBA is bone marrow transplant, a procedure that itself carries     serious risks and is an option for only about 25 percent of patients.      DBA is caused by a mutation (error) in a gene that codes for producing red blood cells from     stem cells (blood-forming cells produced by the bone marrow). In 5 to 10 years, gene transfer     therapy may prove to be an effective treatment for DBA. Before this treatment can be     considered, however, more information is needed about DBA patients and how their stem cells     function. This study will examine: 1) whether stem cells of patients with DBA respond to     G-CSF the same way those of healthy people do. (G-CSF is a drug that causes stem cells to     move from the bone marrow to the blood stream, where they can be collected more easily and in     larger numbers by a procedure called leukapheresis, described below. If G-CSF does not work     well in DBA patients, other collection strategies will have to be explored); and 2) whether     the genetic error in DBA can be corrected by gene transfer into patients' stem cells.      Patients with Diamond-Blackfan anemia 4 years of age and older who weigh at least 27 pounds     and who are dependent on red blood cell transfusions may be eligible for this study.     Candidates will have a medical history taken and a physical examination and will be seen by     the Clinical Center's Department of Medicine Transfusion for leukapheresis evaluation. They     will have a bone marrow aspiration and biopsy to confirm the diagnosis of DBA. For these     tests, the hip area is anesthetized and a needle is used to draw bone marrow from the     hipbone. If needed, the procedure will be done under sedation.      Patients will be given G-CSF by injection under the skin for up to 6 days. Blood and stem     cell counts will be measured from a teaspoon of blood drawn each morning. On the morning of     the fifth dose, the patient will undergo leukapheresis for collection of stem cells. For this     procedure, a large catheter (with a diameter no larger than that of a straw) is placed in an     arm vein to allow blood to flow into a cell separator machine. Most children and some adults     do not have veins large and strong enough for this tubing, so a large intravenous line called     a central line is placed into a large vein in the neck or groin. This is done under     sedation and with a local anesthetic. While the patient lies on a bed or recliner, whole     blood is collected through a catheter in one arm or the central line, the stem cells are     separated out by spinning, then the red cells, platelets and plasma are returned through a     second catheter in the other arm or a second opening in the central line. The procedure takes     about 3 to 5 hours, during which the patient can watch television or videos and have family     members at the bedside for company. When the procedure is completed, the patient's     participation in the protocol ends.      Some of the stem cells collected by leukapheresis will be used for research and some will be     frozen and stored for possible future transplantation into the patient, if required.   "
167398|NCT00011518|"     This study is examining the relationship between ingested arsenic and bladder cancer in two     areas of California where a large percentage of the population was exposed to drinking water     containing arsenic at low to moderate levels.   "
167399|NCT00011531|"     Many spinal cord injury (SCI) and otherwise debilitated patients develop pressure ulcers over     the course of their injury or disease. Despite enhanced wound care management, many pressure     ulcers do not heal completely and require surgical myocutaneous rotational flap coverage.     Even then they often recur.      The objectives of this study are: (1) to conduct a controlled comparative study of the     effectiveness of subatmospheric pressure dressing (SPD) in healing pressure ulcers versus     conventional saline wet-to-moist dressing techniques; (2) to establish indications and     contra-indications for use of SPD In treating pressure ulcers; and (3) to develop a     noninvasive, clinically usable optical digitizer and associated software for measurement of     wound geometry for standardized quantitative assessment and longitudinal monitoring of wound     healing.   "
167400|NCT00011544|"     The project is intended to modify the Functional Independence Measure (FIM) for manual     wheelchair users. It will determine if the new measure is a better measure of community     independence for manual wheelchair users than the FIM. During the Phase 1 of the study it     will then use this new measure to determine whether a home exercise program increases     functional independence in wheelchair users. In Phases II and III of the study 120 manual     wheelchair users will participate to test and validate the new measure and to test the     effectiveness of therapeutic exercise. Subjects will range in age from 20 to 79 yrs. and have     a variety of disabilities.   "
167401|NCT00011557|"     This project will determine the ultimate usefulness of functional magnetic stimulation (FMS)     as an assistive device for voiding in patients with SCI.   "
167405|NCT00017563|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving chemotherapy before surgery     may shrink the tumor so that it can be removed during surgery.      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by     surgery in treating patients who have localized prostate cancer.   "
167408|NCT00017602|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Oblimersen may increase the effectiveness of dexamethasone by     making cancer cells more sensitive to the drug. It is not yet known if dexamethasone is more     effective with or without oblimersen in treating multiple myeloma.      PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with or     without oblimersen in treating patients who have relapsed or refractory multiple myeloma.   "
167409|NCT00017628|"     OBJECTIVES:      I. Determine the efficacy, in terms of disease progression, of high-dose cyclophosphamide and     total body irradiation with T lymphocyte-depleted autologous peripheral blood stem cell or     bone marrow rescue in patients with multiple sclerosis.   "
167410|NCT00017641|"     OBJECTIVES:      I. Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte     globulin followed by peripheral blood stem cell support in patients with systemic lupus     erythematosus.   "
167411|NCT00017654|"     OBJECTIVES:      I. Determine the effect of supplementation with donor T-cell depleted, CD34+ peripheral blood     stem cells on durable engraftment and incidence of graft-versus-host disease in patients with     aplastic anemia undergoing allogeneic bone marrow transplantation.   "
167412|NCT00017680|"     OBJECTIVES: I. Determine the response, disease-free survival, and overall survival of     patients with primary light chain amyloidosis treated with high-dose melphalan and autologous     stem cell transplantation.      II. Determine the toxicity of this regimen in these patients.   "
167413|NCT00017693|"     The purpose is to measure the effectiveness of recombinant human interleukin-4 receptor     (IL-4R) in treating asthma.      Asthma can be caused by the allergic response from breathing in certain irritants.     Interleukin 4 (IL-4), which is naturally produced by the body, plays a major role in this     allergic response. Doctors feel that IL-4 activity may be stopped by giving IL-4R, a product     that binds to IL-4, and thereby decrease the problems of asthma.   "
167414|NCT00017706|"     This randomized clinical trial will determine the efficacy of physicians providing weight     control advice to their overweight and obese patients in primary care practice.   "
167415|NCT00017719|"     The best anti-HIV treatment regimen for pregnant women is not known. Protease inhibitors     (PIs) are often used, but they have side effects that may be harmful for pregnant women. It     is not known if treatment regimens that do not include PIs are as effective in pregnant women     as those that include PIs. This trial will compare two anti-HIV treatment plans, one with and     one without PIs, in women who start HIV treatment during pregnancy. The study will evaluate     the effects of the anti-HIV drugs on the developing infant and prevention of mother-to-child     HIV transmission during pregnancy.   "
167416|NCT00017732|"     RSH/Smith-Lemli-Opitz syndrome (SLOS) is one that causes mental retardation. It is common in     the Caucasian population but rare in African American and African black populations. It has     been shown that SLOS is caused by a specific defect in DHCR7, an enzyme used in cholesterol     metabolism. Studies have already been done to determine the frequency of the SLOS-causing     mutations in various geographic Caucasian populations. This study will investigate the     frequency of the DHCR7 mutations in the African American population. If the frequency     observed suggests that SLOS cases are not being identified in this ethnic group, the study     will provide the rationale for future studies to identify these patients.      The sample size will be 1,600. The study population will consist of archived biological     specimens in the form of newborn screening blood spots from two newborn screening centers,     one in Maryland and one in Pennsylvania. Subjects will be of African American ethnicity,     including blacks of African, Caribbean, and Central American descent.      Genomic DNA will be extracted from blood spots and screened for the six common SLOS     mutations. If SLOS syndrome is found, followup will be attempted for the Maryland samples     (the Pennsylvania samples will be totally anonymous).   "
167417|NCT00017745|"     The Neuromuscular Diseases Section (NDS) is conducting research on certain inherited     myopathies and neuropathies, disorders that lead to disability and sometimes death. NDS,     along with other groups, has identified some disease-causing genes. The National Institutes     of Health Clinical Center proposes new research to identify additional hereditary     neuromuscular diseases and conduct genetic studies in order to localize, clone, and     characterize the diseases.      An expected 50 patients with known or suspected inherited myopathy or neuropathy and their     families will be recruited for this study. If travel to the Clinical Center is impossible,     investigators may come to them to do the tests. Ten to twenty cubic centimeters of blood will     be drawn for DNA extraction and genotyping. Some abnormal movements of muscle atrophy will be     documented by videotaping. If necessary, diagnostic laboratory and radiographic studies will     be done to confirm diagnosis. Because the diseases are hereditary, blood may also be drawn     from family members. The family will be counseled and the participants invited back annually     to investigate the progression of the disease.      Each participant will be evaluated by a history and initial neurological exam. Up to another     20 mL of blood will be drawn for routine blood studies. Other medical care procedures may     include a chest x-ray, EKG and echocardiogram, CT (computed tomography) or MRI (magnetic     resonance imaging) scan, pulmonary function tests, and physical therapy assessment. Possible     research procedures may include MR spectroscopy, nerve conduction study, electromyography,     muscle or nerve biopsy, and lumbar puncture.      The researchers have decided not to inform the family if nonpaternity or adoption is     discovered by the DNA genotyping. Also, because a carrier of the disease gene may not     necessarily develop the disease, family members will not be informed if they are carriers.   "
167429|NCT00027053|"     This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and     placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an     inpatient detoxification program. Subjects will undergo a baseline assessment and random     assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol     detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of     Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)   "
167430|NCT00027066|"     The goal of this study is to compare aspirin to warfarin for the prevention of recurrent     stroke.   "
167418|NCT00017758|"     The purpose of this study is to find out whether certain anti-HIV drugs (efavirenz [EFV] and     nelfinavir [NFV]) affect the amount of certain fat-lowering drugs (atorvastatin, pravastatin,     and simvastatin) in the blood.      Protease inhibitors (PIs), a type of anti-HIV drug, are known to cause increased lipids     (fats) in the blood of HIV-infected patients. EFV also is known to increase blood fats.     HIV-infected patients who take PIs and/or EFV may need to take fat-lowering drugs to correct     this problem. So it is important to look at possible drug interactions when these drugs are     taken together. This study will see if taking EFV or NFV, a protease inhibitor, affects the     blood level of simvastatin, atorvastatin, or pravastatin (all fat-lowering drugs). To obtain     results more quickly, the study population will be healthy HIV-negative volunteers.   "
167419|NCT00017771|"     The purpose of this study is to find out what might increase nerve damage in people with HIV     who have taken drugs for treatment of HIV disease. Another purpose is to see if nerve exams     are done correctly before clinical research sites enroll HIV-infected patients.      Nerve damage is common in patients with HIV infection and can cause serious problems. The     factors that place patients at risk are not well understood. This study will examine these     factors in patients with advanced HIV infection and who have been taking anti-HIV drugs.   "
167420|NCT00017784|"     The purpose of this study is to make valganciclovir available, before it is approved for     marketing, to HIV-infected patients who have cytomegalovirus (CMV) retinitis (eye infection)     and cannot take drugs by injection. This study also will look at the safety of using     valganciclovir as starting and/or ongoing therapy.      CMV can cause serious AIDS-related infections in patients with HIV. Drugs that are effective     against CMV eye infections can be given only by injection; this calls for a thin tube to be     placed into a vein in the chest so that the patient is not put through getting too many     needle sticks. An experimental drug, valganciclovir, is similar to 1 of these approved drugs,     ganciclovir, but is more convenient and easier to use since it can be taken by mouth. Once in     the body, valganciclovir changes to ganciclovir. Studies have shown that valganciclovir     tablets can result in the same level of ganciclovir in the blood as ganciclovir injection.   "
167421|NCT00017797|"     The purpose of this study is to find out if HIV-infected pregnant women who take protease     inhibitors (PIs) are more likely to have blood sugar problems than those who do not take PIs.      HIV-infected people generally are treated with a combination of different types of anti-HIV     drugs, 1 of which is usually a PI. The same holds true for pregnant women, but not much is     known about the use of these drugs in pregnancy. Blood sugar and liver problems caused by     anti-HIV drugs in nonpregnant patients are well known but their effects in pregnancy are not.     Also, certain physical changes brought about by pregnancy may affect the way drugs are     handled in the body. There remains a need for further study into the use of anti-HIV drugs     during pregnancy and their effect on the safety of the mother and baby.   "
167422|NCT00017810|"     The purpose of this study is to see whether changes in diet and behavior lessen the number of     times HIV-positive people get diarrhea (soft or loose stools).   "
167423|NCT00017823|"     The purpose of this study is to see whether acupressure (acupuncture using pressure applied     by the hands instead of needles) can help nausea and vomiting in persons with HIV/AIDS.   "
167424|NCT00017836|"     To examine the role of depression on risk for cardiovascular disease in twins.   "
167425|NCT00027001|"     The goal of this study is to improve the overall physical health and quality of life of     patients attached to mechanical heart devices while awaiting heart transplantation. Qigong,     an ancient Chinese exercise that involves active participation of the individual in the form     of meditation, breathing exercises and simple physical movements, is used in combination with     a structured exercise program. We are testing the hypotheses that Qigong, in combination with     a structured exercise program that combines aerobic and resistance training will improve the     cardiovascular health and improve the quality of life of patients on mechanical heart     devices. To test these hypotheses, we are measuring cardiovascular function and quality of     life parameters in patients attached to mechanical heart devices who have participated in the     exercise program and have practiced Qigong, and comparing these measures to patients who     participated in the exercise program, but did not practice Qigong. Information gained from     this research will serve as a basis from which the application of exercise training and     Qigong can be applied to the treatment of other chronic diseases in which the physical     conditioning and/or quality of life of individuals is compromised.   "
167426|NCT00027014|"     This is a series of studies in healthy volunteers to assess the potential for adverse     interactions between St. John's wort (SJW) extract and two narcotic (opioid) pain     medications: oxycodone and fentanyl. In the case of oxycodone, we are interested in whether     SJW treatment promotes the metabolism of oxycodone, such that it lowers the effectiveness of     standard doses of oxycodone in treating pain problems. For the fentanyl study, we will     investigate whether SJW treatment will interfere with the delivery of fentanyl to the brain     and diminish it's effectiveness to relieve pain. There is evidence to suggest that SJW     treatment may increase the activity of a transporter protein, named P-glycoprotein (Pgp), in     the blood-brain barrier (BBB) that protects the brain from exposure to drugs and other     dietary and environmental toxins.   "
167427|NCT00027027|"     The purpose of this Phase I study is to test the safety of rhuMAb 2C4 to see what effects     (good and bad) it has on patients with certain types of cancer, and also to find the highest     dose of rhuMAb that can be given without causing severe side effects. All study participants     will be assigned to specific group to evaluate different dosages of rhuMAb 2C4. The study is     scheduled to run for up to one year depending on how patients respond to the study treatment.   "
167428|NCT00027040|"     The purpose of this study is to compare pictures of the brain of HIV-infected people with     memory problems before and after treatment with selegiline. Selegiline is the study drug     received through A5090.      HIV patients generally develop memory problems late in the disease. This will be examined     using noninvasive proton magnetic resonance spectroscopy (1H-MRS). The effect of the drug     selegiline on memory problems also will be examined.   "
167431|NCT00027079|"     This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both     alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All     subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will     be completed at 1, 3, 6, and 9 months after treatment.   "
167432|NCT00027092|"     The purpose of this study is to find out if testosterone gel affects how the body handles     insulin and glucose.      Specific anti-HIV treatments may increase a patient's risk of certain diseases by causing     metabolic problems such as reduced sensitivity to insulin. This substudy will examine how     testosterone affects insulin sensitivity. If testosterone increases insulin sensitivity in     the patients, then giving testosterone to HIV-infected patients may allow the continuation of     anti-HIV treatments without increasing the patients' risk of disease. The test used to     determine insulin sensitivity will be a modified frequently sampled intravenous glucose     tolerance test (FSIVGTT), which can accurately measure insulin sensitivity.   "
167630|NCT00030121|"     The purpose of this study is to determine whether Carperitide is safe and effective in the     management of Acute Respiratory Distress Syndrome (ARDS).   "
167433|NCT00027105|"     This study will examine the frequency and severity of problems in women with breast cancer     during the first year after initial medical treatment, including:        -  Physical impairments, such as loss of strength or flexibility, increased weight and          swelling        -  Symptom distress, such as pain, fatigue and weakness.        -  Functional limitations and disabilities, such as loss of independence in activities of          daily living (e.g., grooming, bathing, dressing, driving a car), work and social and          recreational activities.      It will identify factors associated with these problems and try to determine their     relationship to them.      Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible     for this study. Participants will be drawn from patients referred to the National Naval     Medical Center for diagnosis and treatment during 2000-20001.      Participants will be interviewed and their medical records reviewed for past medical history,     history of the present illness and social and recreational history. They will be seen five     times over a 1-year period (initial visit and at 3, 6, 9, and 12 months), for 30-minute     visits, which will include the following:        -  Interview about past medical history and present illness, social and recreational          activities, functional independence at work and during activities of daily living.        -  Complete health survey and upper limb disability questionnaire; physical activity          questionnaire to be completed at 6 and 12 months after medical treatment begins. The          questionnaires take about 30 to 40 minutes to complete.        -  Upper body examination, including pain measurement using a 10-point scale, an upper limb          lift test, and measures of upper limb volume and girth.   "
167434|NCT00027118|"     This study will examine the frequency and severity of problems in women with breast cancer     for 2 years following initial medical treatment, including:        -  Physical impairments, such as loss of strength or flexibility, increased weight and          swelling.        -  Symptom distress, such as pain, fatigue and weakness.        -  Functional limitations and disabilities, such as loss of independence in activities of          daily living (e.g., grooming, bathing, dressing, driving a car), work and social and          recreational activities.      It will identify factors associated with these problems and try to determine their     relationship to them.      Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible     for this study. Women who have a breast biopsy negative for cancer will also be enrolled as     control subjects. Participants will be drawn from patients referred to the National Naval     Medical Center for diagnosis and treatment during 2001-2003.      Participants will be evaluated over a 2-year period during an initial baseline visit (before     medical treatment or biopsy) and follow-up visits at 1, 3, 6, 12, 18 and 24 months following     procedures:        -  Interview about past medical history and present illness, social and recreational          activities, functional independence at work and during activities of daily living.        -  Completion of questionnaires including health survey, upper limb disability          questionnaire, and physical activity questionnaire. (Questionnaires are completed only          at baseline and 12 and 24 months after medical treatment begins.) The questionnaires          take about 30 to 40 minutes to complete.        -  Upper body examination, including pain measurement using a 10-point scale, active and          passive range of motion measures, manual muscle testing measures using a 10-point scale,          timed upper limb lift test, and measures of upper limb volume and girth.   "
167435|NCT00027131|"     Description: The trial is designed to determine the response of the immune system of patients     with breast cancer to a vaccine made from their own tumor. Researchers believe that this     particular vaccine, which is made from purified heat shock proteins taken from each patient's     tumor, might alert the body's immune system to recognize and attack invading cancer. To be     considered potentially eligible for this study you must be a high risk breast cancer patient     and have a tumor that can be removed surgically.      Length/Duration: Vaccinations are administered weekly for six weeks. Follow up visits to the     clinic are every three months for two years, then every six months thereafter.   "
167436|NCT00027144|"     Description: The trial is designed to determine the response of the immune system of patients     with CML to a vaccine made from their own tumor. Researchers believe that this particular     vaccine, which is made from purified heat shock proteins taken from each patient's tumor,     alerts the body's immune system to recognize and attack invading cancer. To be considered     potentially eligible for this study you must have CML in the chronic phase.      Length/Duration: Vaccinations will be administered weekly for eight weeks. One clinic follow     up visit will be scheduled two weeks after the final vaccination.   "
167437|NCT00027157|"     This study will determine whether and how nitrites and nitrates in the diet affect the level     of nitric oxide gas that is breathed out in air. Nitric oxide is involved in many bodily     processes, such as immune function, nerve signal transmission, inflammation, and dilation of     blood vessels and bronchial tubes (tubes that branch out from the trachea into the lungs).      Healthy male volunteers age 18 years or older who have not smoked for at least 5 years may be     eligible for this study. Candidates will undergo blood and urine tests, breathing tests, and     an electrocardiogram.      Participants will follow two special diets for 3 days each. One is a low-nitrate and nitrite     diet, and the other is a high-nitrate and nitrite diet. Both diets must be completed within a     month's time. Participants will be admitted to the NIH Clinical Center for two 3-night     hospital stays during the two diet periods, but may go out on passes at any time. While on     the diets, they may consume only food prepared by the NIH Nutrition Department; eating other     foods will seriously affect the study results. Meals may be eaten at the NIH Clinical Center,     or packaged meals prepared by the Nutrition Department can be taken out. Participants may not     engage in any heavy exercise during the diet periods, as exercise affects nitric oxide     levels.      Blood samples of about 4 milliliters, or 1 teaspoon, each will be collected before starting     each diet and at the end of each diet to measure blood levels of nitrate and nitrite.     Additional blood samples, totaling about 2 tablespoons, will be collected for research. Each     day, participants will have a test to measure exhaled nitric oxide levels. This involves     blowing air into a mouthpiece attached to a machine that measures levels of the gas in each     breath.   "
167438|NCT00027170|"     This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate the     heart and blood vessels of patients with cardiovascular disease, including better detection     of myocardial infarction (heart attack) and blockage of heart and leg arteries.      Patients 18 years of age and older with cardiovascular disease may be eligible for this     study.      All participants will have magnetic resonance imaging of the heart. MRI uses a magnetic field     and radio waves to show structural and chemical changes in tissues. For the procedure, the     patient lies on a table surrounded by a metal cylinder (the scanner). A 'gadolinium contrast'     material may be injected into the patient s vein during part of the study to brighten the     images. Patients wear earplugs during the scan to muffle loud knocking sounds caused by the     electrical switching of the magnetic fields. They will be asked to hold their breath     intermittently for 5 to 20 seconds during the scan. They will be monitored with an     electrocardiogram (EKG) during the procedure and will be in contact by intercom at all times     with the person performing the scan. Patients can request to stop the study and come out of     the scanner at any time. The procedure may last from 30 to 90 minutes. An echocardiogram a     test that uses sound waves to produce pictures of the heart and blood vessels-may be done to     confirm the MRI findings. In addition, patients may undergo one or more of the following     optional studies:        -  Dobutamine stress MRI - This test uses dobutamine-a medicine that simulates exercise by          increasing heart rate and heart function-to detect blockages in the coronary arteries          (vessels that supply oxygen and nutrients to the heart) and locate areas of the heart          that are permanently damaged, perhaps by a previous heart attack. For this test, MRI          pictures of the heart are taken before, during and after administration of dobutamine.          Gadolinium may be injected during part of the study to brighten the images. An EKG will          be used to monitor the heart during the procedure.        -  Vasodilator MRI - The procedure and objectives of this test are the same as those          described for dobutamine stress MRI, except that this study uses dipyridamole or          adenosine. These drugs dilate blood vessels, causing increased blood flow to the heart.        -  Plethysmography MRI - This test determines the presence and severity of narrowing in          arteries that supply blood to the leg. Blockage of these vessels often causes pain while          walking. This study will compare plethysmography MRI with venous occlusion          plethysmography, an older method of measuring blood flow in the legs. For venous          occlusion plethysmography, a large blood pressure cuff is placed around the upper leg          and a strain gauge (thin elastic band) is placed around the calf. The pressure cuff is          inflated very tightly for 5 minutes to block blood flow to the leg, and another pressure          cuff over the ankle is also inflated. When the large cuff is deflated, blood rushes to          the leg, a smaller cuff is inflated to a low pressure, and the strain gauge measures the          maximum blood flow to the leg for 1 or 2 more minutes. This procedure is done once or          twice outside the MRI scanner and once or twice inside the scanner. The scans are          performed as described above for the dobutamine and vasodilator studies. The strain          gauge is not used for plethysmography MRI the MRI pictures are used to measure flow.   "
167590|NCT00029536|"     The purpose of this investigation was to determine if cyclic adjunctive progesterone     supplement is superior to placebo in the treatment of intractable seizures in women with and     without catamenial epilepsy.   "
167439|NCT00027183|"     Some bacteria that cause disease can produce toxic substances that may worsen the disease.     Pseudomonas aeruginosa is a bacteria that can produce a variety of toxins and is of special     interest for patients with cystic fibrosis and repeated long term lung infections.      The goal of this study is to determine whether specific toxins produced by Pseudomonas     aeruginosa may be important in the disease process of chronic lung infections of patients     with cystic fibrosis.      This study will attempt to measure bacterial production of toxins in blood and sputum and     immune system response to toxins in the blood.   "
168025|NCT00038922|"     To explore the safety of orally delivered rhIL-11 in patients with mild to moderate     left-sided ulcerative colitis.      To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples     and in colonic biopsy tissue samples.   "
167440|NCT00027196|"     Genetically inherited heart diseases (familial cardiopathies) are conditions affecting the     heart passed on to family members by abnormalities in genetic information. These conditions     are responsible for many heart related deaths and illnesses.      Researchers are interested in learning more about the specific genetic abnormalities causing     heart diseases. In addition, they would like to find out how these abnormal genes can     contribute to the development of other medical problems.      In order to do this, researchers plan to study patients and family members of patients     diagnosed with genetically inherited heart disease. Those people participating in the study     will undergo a variety of tests including blood tests, echocardiograms, and magnetic     resonance imaging studies (MRI). These tests will be used to help researchers find the     genetic problem causing the familial cardiopathy.      Researchers hope that the information gathered from this study can be used to develop better     medical care through early diagnosis, management, and treatment plans.   "
167441|NCT00027209|"     The goal of this study is to evaluate the effect of synthetic hormone replacement therapy on     anti-seizure medication levels, menopausal symptom relief, and seizure frequency and safety     in menopausal women with epilepsy.   "
167442|NCT00027222|"     The goal of the Early Treatment for Retinopathy of Prematurity Study (ETROP) is to test the     hypothesis that earlier treatment in carefully selected cases will result in an overall     better visual outcome than treatment at the conventional CRYO-ROP threshold point in the     disease.   "
167443|NCT00027235|"     Recently, an epidemic of pulmonary disease has been recognized among workers in a popcorn     factory in Jasper, Missouri. The exposure agent has not yet been identified, but suspects     include butter flavoring and the powdered salt used in the mixing room. This disease     resembles Bronchiolitis Obliterans Syndrome, an illness that makes it difficult to breathe.     Of the 117 workers studied, one year later, 25 subjects whom were working in the mixing room     or in the microwave packaging area have had decreases in lung function seven times the norm     for their age. Industrial hygiene experts revealed that dust concentrations of salt and other     flavorings were much higher in the mixing room compared to the office and outdoor work areas.     Recently, rats were exposed to vapors created by heating the butter flavor compound obtained     from this plant. Six-hour exposure to vapors at very high concentration resulted in     significant damage to the breathing apparatus. Thus, there is clinical, epidemiological, and     animal toxicity data that appears to implicate some constituent present during the mixing of     the butter flavoring, salt, and oil causing a form of obstructive airway disease that has     been rapidly progressive in a number of workers. It is not clear what the pathophysiologic     nature of this entity is, though it resembles Bronchiolitis Obliterans Syndrome. It is not     known what the long term consequence of this will be on the active workers, nor is it clear     whether preventive measures taken to reduce exposures in the mixing room and elsewhere in the     plant are going to be effective.   "
167444|NCT00027248|"     Central venous catheters (CVCs) are used in patient care for such purposes as the     administration of medication, fluids, blood products and for functions such as hemodialysis     and plasmapheresis. However, the use of CVCs can cause complications such as life-threatening     bloodstream infections (BSI).      BSIs are caused by organisms from the skin's surface tracking down the catheter's outer     surface. The organisms grow on the catheter surface (catheter colonization) which is followed     by seeding into the bloodstream. BSIs can be difficult to treat and the mortality rate is as     high as 35% in Intensive Care patients with a catheter-related BSI. It is estimated that up     to 70,000 patients in the US die each year from catheter-related BSI.      MBI 226 is a new drug that, when applied to the skin surrounding the catheter insertion site,     may prevent organisms on the skin from migrating down the catheter and entering the     bloodstream and therefore decrease the incidence of catheter-related BSI in patients with     CVCs.   "
167445|NCT00027261|"     The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe     and to study how the immune system responds to the vaccine. This trial is designed to     determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune     response.      As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose.     The higher dose of the vaccine to be used in this study has not been given to humans     previously. High doses of a similar vaccine have been given to a few people without serious     side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger     immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the     amount needed for the maximum immune response. Because the exact relationship between an     increased immune response and its effectiveness in preventing HIV infection is uncertain, the     HVTN will use the highest dose that can be manufactured.   "
167465|NCT00027664|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Thalidomide may     stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if     interferon alfa is more effective with or without thalidomide in treating metastatic kidney     cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of interferon alfa with or     without thalidomide in treating patients who have metastatic kidney cancer.   "
167466|NCT00027677|"     RATIONALE: Halofuginone hydrobromide may stop the growth of solid tumors by stopping blood     flow to the tumor.      PURPOSE: Phase I trial to study the effectiveness of halofuginone hydrobromide in treating     patients who have progressive advanced solid tumors.   "
167467|NCT00027690|"     Phase II trial to study the effectiveness of gefitinib in treating patients who have     persistent or recurrent endometrial cancer. Biological therapies such as gefitinib may     interfere with the growth of tumor cells and slow the growth of endometrial cancer.   "
167611|NCT00029848|"     To assess the effect on weight loss and weight maintenance over a period of one year when     prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes   "
167471|NCT00027742|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.     Combining chemotherapy with interferon alfa may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon     alfa in treating patients who have stage III or stage IV melanoma.   "
167705|NCT00022477|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who     have recurrent or metastatic colorectal cancer.   "
167446|NCT00027274|"     Background:      A prospective cohort of Inherited Bone Marrow Failure Syndrome (IBMFS) will provide new     information regarding cancer rates and types in these disorders.      Mutations in IBMFS genes are relevant to carcinogenesis in sporadic cancers.      Patients with IBMFS who develop cancer differ in their genetic and/or environmental features     from patients with IBMFS who do not develop cancer.      These cancer-prone families are well suited for cancer screening and prevention trials     targeting those at increased genetic risk of cancer.      Carriers of IBMFS gene mutations are at increased risk of cancer.      The prototype disorder is Fanconi's Anemia (FA); other IBMFS will also be studied.      Objectives:      To determine the types and incidence of specific cancers in patients with an IBMFS.      To investigate the relevance of IBMFS gene mutations in the carcinogenesis pathway of the     sporadic counterparts of IBMFS-associated cancers.      To identify risk factors for IBMFS-related cancers in addition to the primary germline     mutations.      To determine the risk of cancer in IBMFS carriers.      Eligibility:      North American families with a proband with an IBMFS.      IBMFS suspected by phenotype, confirmed by mutation in an IBMFS gene, or by clinical     diagnostic test.      Fanconi's anemia: birth defects, marrow failure, early onset malignancy; positive chromosome     breakage result.      Diamond-Blackfan anemia: pure red cell aplasia; elevated red cell adenosine deaminase.      Dyskeratosis congenita: dysplastic nails, lacey pigmentation, leukoplakia; marrow failure.      Shwachman-Diamond Syndrome: malabsorption; neutropenia.      Amegakaryocytic thrombocytopenia: early onset thrombocytopenia.      Thrombocytopenia absent radii: absent radii; early onset thrombocytopenia.      Severe Congenital Neutropenia: neutropenia, pyogenic infections, bone marrow maturation     arrest.      Pearson's Syndrome: malabsorption, neutropenia, marrow failure, metabolic acidosis; ringed     sideroblasts.      Other bone marrow failure syndromes: e.g. Revesz Syndrome, WT, IVIC, radio-ulnar synostosis,     ataxia-pancytopenia.      First degree relatives of IBMFS-affected subjects as defined here, i.e. siblings (half or     full), biologic parents, and children.      Grandparents of IBMFS-affected subjects.      Patients in the general population with sporadic tumors of the types seen in the IBMFS (head     and neck, gastrointestinal, and anogenital cancer), with none of the usual risk factors (e.g.     smoking, drinking, HPV).      Design:      Natural history study, with questionnaires, clinical evaluations, clinical and research     laboratory test, review of medical records, cancer surveillance.      Primary endpoints are all cancers, solid tumors, and cancers specific to each type of IBMFS.      Secondary endpoints are markers of pre-malignant conditions, such as leukoplakia, serum or     tissue evidence of carcinogenic viruses, and bone marrow morphologic myelodyplastic syndrome     or cytogenetic clones..   "
167447|NCT00027287|"     This study will compare the side effects of two laser treatments for diabetic macular edema,     a common condition in patients with diabetes. In macular edema, blood vessels in the retina-a     thin layer of tissue that lines the back of the eye-become leaky and the retina swells. The     macula-the center part of the retina that is responsible for fine vision-may also swell and     cause vision loss. Traditional laser treatment (argon blue or green or yellow) for macular     swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision.     Studies with a different type of laser (diode) have shown no adverse effects to the retina,     but long-term effects of this treatment are not known. The results of this study on side     effects of the treatments will be used to design a larger study of effectiveness. This study     will also examine whether vitamin E can reduce the damage caused by laser treatment. Patients     with diabetic eye disease who take vitamin E have increased blood flow through the vessels of     the retina, as well as improved kidney function. Patients with elevated cholesterol levels     will be invited to participate in a cholesterol reduction part of the study to compare     normal-pace cholesterol reduction with accelerated reduction.      Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema may be     eligible for this study. Candidates will be screened with the following tests and procedures:        -  Medical history - to review past medical conditions and treatments.        -  Physical examination - to measure vital signs (pulse, blood pressure, temperature,          breathing rate) and examine the head and neck, heart, lungs, abdomen, arms and legs.        -  Eye examination - to assess visual acuity (eye chart test) and examine pupils, lens,          retina, and eye movements. The pupils will be dilated with drops for this examination.        -  Blood tests - to measure cholesterol and vitamin E blood levels, blood clotting time,          hemoglobin A1C (a measure of diabetes control), and to evaluate liver and kidney          function.        -  Photography - to help evaluate the status of the retina and changes that may occur in          the future. Special photographs of the inside of the eye are taken using a camera that          flashes a bright light into the eye. From 2 to 20 pictures may be taken, depending on          the eye condition.        -  Fluorescein angiography - to evaluate the eye's blood vessels. A yellow dye is injected          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina          are taken using a camera that flashes a blue light into the eye. The pictures show if          any dye has leaked from the vessels into the retina, indicating possible blood vessel          abnormality.      Participants will be randomly assigned to receive one of the two laser treatments. They will     also be randomly assigned to take 1600 IU of vitamin E or placebo (an inactive, look-alike     pill) daily. For the laser treatment, eye drops are put in the eye to numb the surface and a     contact lens is placed on the eye during the laser beam application. Several visits may be     required for additional laser treatments. The maximum number of treatments depends on how     well the treatment is working.      On their first visit, patients will be given vitamin C. After taking the vitamin for 1 month,     they will return to the clinic for the first laser treatment. They will followed 1, 3, 6, 9,     and 12 months after the first treatment, and then every 6 months until either 1) the patient     returns for a 3-year visit; 2) the last enrolled patient returns for the 1-year visit, or the     patient requests to leave the study. During these visits, several of the exams described     above will be repeated to evaluate the response to treatment and check for side effects of     the vitamin E.   "
167448|NCT00027300|"     The purpose of this study is to determine the safety and efficacy of natalizumab in the     treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis     (MS). It is hoped that natalizumab will prevent certain types of white blood cells from     moving out of the bloodstream into organs, including the brain, that are being damaged by     autoimmune disease (a disease in which the body's own immune system attacks certain organs).     These white blood cells are thought to cause inflammation that can result in lesions (small     areas of damage) in the brain. These lesions are thought to be the cause of relapses and     disability in MS.   "
167449|NCT00027326|"     Background:      -Research in NCI's Radiation Oncology Branch depends on the availability of blood and urine     samples from patients receiving radiation therapy.      Objectives:      -To explore the effects of radiation therapy on gene expression in white blood cells, to     measure radiation damage in red blood cells and to examine changes in hormone levels in the     blood and urine after radiation therapy.      Eligibility:      -Patients 18 years of age and older who are receiving radiation therapy.      Design:        -  Blood and urine samples are collected when participants enter the study.        -  Additional samples may be collected at different times during and after treatment.          Ideally, samples are obtained before, at the completion of, and 1 month following          radiation therapy. Blood samples usually will be collected during routine patient          monitoring procedures and will not require an additional needle stick.        -  A total of 300 patients will be studied at the NCI in Bethesda, MD, Johns Hopkins          University in Baltimore and the University of Pennsylvania in Philadelphia.   "
167450|NCT00027339|"     Because people infected with HIV strains that are resistant to anti-HIV drugs have fewer     effective treatment options, selecting an effective anti-HIV drug combination is difficult. A     combination of protease inhibitors (PIs), when added to a patient's current anti-HIV therapy,     may decrease viral load and increase drug activity. Tests that measure drug levels in the     blood and tests to evaluate the drug resistance of HIV may also be helpful in choosing the     best anti-HIV drug combination for a patient. This study will determine whether using these     tests to choose a drug combination and adding PIs to that combination will improve the     patient's response to anti-HIV therapy.   "
167451|NCT00027469|"     This study will use magnetic resonance imaging (MRI) to picture the kidney and renal arteries     (arteries that supply blood to the kidney) in patients scheduled for kidney artery angiogram     and angioplasty/stenting procedures. An angiogram is a way of taking pictures of arteries     that shows areas of narrowing caused by atherosclerosis-a buildup of plaque on the vessel     wall. Angioplasty/stent is a treatment procedure in which a balloon-tipped catheter is     inserted in the artery and advanced to the area of blockage to open the vessel, increasing     blood flow to the kidney. A permanent metal tube (stent) may or may not be put in place to     maintain the opening. During either of these invasive procedures, small pieces of plaque can     break off and travel in the blood to lodge elsewhere in the body. This is called     embolization. Lodged in the kidney, the embolus can impair kidney function. Currently, these     emboli cannot be detected. A new way of visualizing the kidneys that allows detection of     emboli may reveal whether material has moved to the kidneys and predict if there will be any     kidney damage.      Patients 21 years of age and older with suspected kidney artery disease scheduled for     invasive angiographic evaluation in NIH protocol 95-H-0047 may be eligible for this study.      Participants will be assigned to one of two study groups, based on the angiogram findings and     the decision to have the angioplasty/stent procedure. Participants in both groups will have     baseline MRI scans up to 2 weeks before the invasive procedure (angiogram with or without     angioplasty/stent) and again within a day after the procedure. Patients who undergo     angioplasty/stent will have another MRI study within about a month following the procedure.      MRI uses a magnetic field and radio waves to produce images of body tissues. The patient lies     on a table that slides into a large hollow tube (the scanner). During part of the scan, a     material called gadolinium contrast may be injected into a vein. This substance brightens the     images to better show the kidneys, their blood vessels and blood flow. The procedure lasts     from about 1 to 2 hours. During the MRI, the heart is monitored with an electrocardiogram     (EKG) and breathing is monitored with a flexible belt. Blood pressure is measured     intermittently. The patient can communicate with a staff member at all times.      Blood samples will be drawn from an arm vein at the initial clinic visit, within a day after     the procedure and about 1 week after the procedure. For patients who had the     angioplasty/stent procedure, a third blood sample will be taken within another 6 six weeks.     The blood samples will be used to check for changes in kidney function.   "
167468|NCT00027703|"     This randomized phase II trial is to see if combination chemotherapy works better with or     without bevacizumab in treating patients who have malignant mesothelioma. Drugs used in     chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or     die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways.     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help     kill them or deliver cancer-killing substances to them. It is not yet known if combination     chemotherapy works better with or without bevacizumab in treating malignant mesothelioma.   "
167469|NCT00027716|"     RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for     tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who     have advanced or metastatic sarcoma.   "
167470|NCT00027729|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in     treating patients who have advanced colorectal cancer that has not responded to irinotecan.   "
167452|NCT00027482|"     This study will explore the responses of the immune system to infection with HIV and other     pathogens and the changes in these responses over time.      Healthy normal volunteers and HIV-infected patients 18 years of age or older may be eligible     for this study.      Prior to enrollment and yearly thereafter, vital signs, height and weight will be recorded. A     medical history will be obtained if relevant to the laboratory research for which the sample     will be used. A more extensive history and physical exam is not required but may be performed     if deemed necessary by the VRC clinician. A complete blood count will be performed on the day     of enrollment and yearly thereafter. Samples will be collected in the following manner:      Blood will be drawn from a needle in an arm vein one or more times during the course of the     study. From 20 to 150 cc (4 to 30 teaspoonfuls) of blood will be collected at a time. No more     than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period.      Urine and saliva samples will be collected by the volunteer in private.      Swab samples will be collected by a nurse or doctor, using a cotton swab to brush inside the     mouth.      Samples may be used for the following tests:        -  Hepatitis and other viral screening-This may include screening for different types of          viral liver infections, such as hepatitis A, B, C, D, E, or G; for cytomegalovirus          (related to the herpes virus); and for varicella zoster virus (responsible for chicken          pox in children and shingles in adults).        -  Genetic testing-DNA in blood cells may be examined for genetic mutations (physical or          chemical changes) or deletions (missing pieces) that affect substances involved in the          body's ability to mount an inflammatory immune response. Alterations in the genes for          some of these substances have been shown to influence HIV infection.        -  HLA testing-HLA type is a genetic marker of the immune system. Determining HLA type is          necessary in order to do certain research studies. Some HLA types have been associated          with an increased risk of diseases like arthritis and other rheumatologic problems. HLA          testing may be used to try to identify factors associated with the rate of progression          of HIV disease or related conditions.        -  Other laboratory tests as clinically indicated or required for research needs.      Some samples collected in this study may be stored for future research.They will be labeled     without identifying information.      Those with interesting or strongly positive immune responses may be asked to return to the     VRC Clinic to provide samples of urine or oral secretions.   "
167453|NCT00027495|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. Curcumin may be effective in preventing the development of colon     cancer.      PURPOSE: Phase I trial to determine the dose amount of curcumin that can be tolerated to help     in preventing colon cancer in healthy men and women.   "
167454|NCT00027508|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients     who have malignant mesothelioma that cannot be removed by surgery.   "
167455|NCT00027521|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy     drugs to enter tumor cells. Combining chemotherapy with electroporation therapy may kill more     tumor cells.      PURPOSE: Phase I trial to study the effectiveness of electroporation therapy and bleomycin in     treating patients who have locally advanced pancreatic cancer.   "
167456|NCT00027534|"     RATIONALE: Vaccines made from a person's white blood cells that have been treated in the     laboratory may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have advanced or metastatic cancer.   "
167457|NCT00027547|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may be able to replace     immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the     transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and donor     white blood cells may prevent this from happening.      PURPOSE: Phase I/II trial to determine the effectiveness of combination chemotherapy and     total-body irradiation followed by peripheral stem cell transplantation in treating patients     who have acute lymphoblastic leukemia.   "
167458|NCT00027560|"     RATIONALE: Giving low doses of chemotherapy, such as melphalan and fludarabine, and a     monoclonal antibody, such as alemtuzumab, before a donor bone marrow or peripheral blood stem     cell transplant helps stop the growth of cancer cells. It also stops the patient's immune     system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor     effect). Sometimes the transplanted cells from a donor can also make an immune response     against the body's normal cells. Giving cyclosporine after the transplant may stop this from     happening.      PURPOSE: This phase II trial is studying how well fludarabine, melphalan, alemtuzumab, and     peripheral stem cell transplant work in treating patients with hematologic cancer.   "
167459|NCT00027573|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune     cells that were destroyed by chemotherapy used to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by donor     peripheral stem cell transplantation in treating patients who have metastatic or unresectable     kidney cancer.   "
167460|NCT00027586|"     RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an     effective treatment for metastatic melanoma.      PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients     who have metastatic melanoma.   "
167461|NCT00027599|"     Phase II trial to study the effectiveness of APC8015 combined with bevacizumab in treating     patients who have undergone radiation therapy and/or surgery and who have progressive     prostate cancer. Biological therapies such as APC8015 use different ways to stimulate the     immune system and stop cancer cells from growing. Monoclonal antibodies such as bevacizumab     can locate tumor cells and kill them without harming normal cells. Combining monoclonal     antibody therapy with biological therapy may kill more cancer cells.   "
167462|NCT00027612|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     tumor cells. Irinotecan may make the tumor cells more sensitive to radiation therapy.      PURPOSE: This phase I/II trial is studying the side effects of irinotecan given together with     radiation therapy followed by irinotecan and carmustine and to see how well it works in     treating patients with newly-diagnosed glioblastoma multiforme.   "
167463|NCT00027625|"     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer     cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Combining gefitinib with chemotherapy     may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining gefitinib with temozolomide in     treating patients who have malignant primary glioma.   "
167464|NCT00027638|"     RATIONALE: Thalidomide may stop the growth of neuroendocrine tumors by stopping blood flow to     the tumor.      PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who     have metastatic neuroendocrine tumors.   "
167472|NCT00027768|"     RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver     cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more     effective than no further treatment after surgery.      PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in     treating patients who have undergone surgery for liver cancer.   "
167473|NCT00027781|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who have     progressive prostate cancer that has not responded to hormone therapy.   "
167474|NCT00027794|"     RATIONALE: Radical prostatectomy may be an effective treatment for locally advanced prostate     cancer.      PURPOSE: Phase II trial to study the effectiveness of radical prostatectomy in treating     patients who have locally advanced prostate cancer.   "
167475|NCT00027807|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Combining different types of biological therapies may kill more     tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining different biological     therapies in treating women who have stage IV breast cancer.   "
167476|NCT00027820|"     This phase I/II trial studies whether a new kind of blood stem cell (bone marrow) transplant,     that may be less toxic, is able to treat underlying blood cancer. Stem cells are seed cells     necessary to make blood cells. Researchers want to see if using less radiation and less     chemotherapy with new immune suppressing drugs will enable a stem cell transplant to work.     Researchers are hoping to see a mixture of recipient and donor stem cells after transplant.     This mixture of donor and recipient stem cells is called mixed-chimerism. Researchers hope     to see these donor cells eliminate tumor cells. This is called a graft-versus-leukemia     response.   "
167477|NCT00027833|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs     used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Tetanus toxoid may make tumor cells more sensitive to chemotherapy and     vaccine therapy.      PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy and vaccine     therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients     who have metastatic colorectal cancer.   "
167478|NCT00027846|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during     surgery.      PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy     either alone or after chemotherapy and second surgery in treating children who have undergone     surgery for localized ependymoma.   "
167479|NCT00027859|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as     ketoconazole may stop the production of androgens. Drugs used in chemotherapy use different     ways to stop tumor cells from dividing so they stop growing or die. It is not yet known     whether hormone therapy is more effective than combination chemotherapy in treating prostate     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with that     of combination chemotherapy in treating patients who have prostate cancer that has been     previously treated with androgen suppression.   "
167480|NCT00027872|"     Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their     growth. Phase II trial to study the effectiveness of tipifarnib in treating older patients     who have previously untreated acute myeloid leukemia   "
167481|NCT00027885|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.     Others find cancer cells and help kill them or deliver cancer-killing substances to them.     Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.      PURPOSE: This randomized phase II trial is to see if docetaxel with or without bevacizumab     followed by surgery, radiation therapy, and combination chemotherapy works better in treating     patients who have stage III or stage IV breast cancer.   "
167482|NCT00027898|"     Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their     growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Phase I trial to study the effectiveness of combining bortezomib     with carboplatin and etoposide in treating patients who have advanced solid tumors that have     not responded to previous treatment   "
167483|NCT00027911|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Colony-stimulating factors such as sargramostim increase the number of immune cells found in     bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may be effective     in treating soft tissue sarcoma.      PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with     sargramostim in treating patients who have stage II, stage III, or stage IV soft tissue     sarcoma.   "
167484|NCT00027924|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may be able to replace immune     cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the     transplanted cells are rejected by the body's normal tissues. Drugs such as cyclosporine may     prevent this from happening.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     peripheral stem cell transplantation in treating patients who have chronic myelogenous     leukemia or myelodysplastic syndrome.   "
167612|NCT00029861|"     To assess the effects of weight loss and weight maintenance over a period of two years when     prescribed with a hypocaloric diet in obese patients with or without comorbidities   "
167513|NCT00028353|"     If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or     III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate     biopsy, you may be eligible for this study. This is a study of an investigational medication     that may reduce high grade PIN and prevent the occurrence of prostate cancer. This study is     currently enrolling up to 500 men at approximately 60 locations in the United States.   "
167485|NCT00027937|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.     Biological therapies such as interleukin-2 use different ways to stimulate the immune system     and stop cancer cells from growing.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, peripheral     stem cell transplantation, and interleukin-2 in treating patients who have solid tumors or     lymphoma.   "
167486|NCT00027963|"     RATIONALE: Gabapentin may be effective in relieving pain and other symptoms of peripheral     neuropathy. It is not yet known if gabapentin is effective in treating peripheral neuropathy     in cancer patients undergoing chemotherapy.      PURPOSE: Randomized phase III trial to determine the effectiveness of gabapentin in treating     pain and other symptoms of peripheral neuropathy in cancer patients undergoing chemotherapy.   "
167487|NCT00027976|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of celecoxib may be an effective way to prevent     actinic keratoses.      PURPOSE: Randomized phase II/III trial to determine the effectiveness of celecoxib in     preventing skin cancer in patients who have actinic keratoses.   "
167488|NCT00027989|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with     gemcitabine in treating women who have metastatic breast cancer.   "
167489|NCT00028002|"     Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in     treating patients who are undergoing surgery for primary or recurrent malignant     gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by     blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after     surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining     after surgery.   "
167490|NCT00028015|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have     recurrent or metastatic colorectal cancer.   "
167491|NCT00028028|"     Randomized phase II trial to compare the effectiveness of different doses of CCI-779 in     treating patients who have extensive-stage small cell lung cancer. Drugs used in chemotherapy     use different ways to stop tumor cells from dividing so they stop growing or die   "
167492|NCT00028067|"     The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in     their ability to reduce viral load.   "
167493|NCT00028080|"     This study is designed to establish a population of patients with Lyme disease for     evaluation, treatment and follow-up to learn more about the infection.      Patients with active Lyme disease may be eligible for this study.      Participants will have a medical history and physical examination and diagnostic evaluations     as appropriate to their individual condition. Laboratory tests may include routing blood and     urine tests, X-rays, or other imaging studies, body fluid or tissue cultures, skin biopsy and     tests for allergic or immune responses. Treatment will include only medications approved by     the Food and Drug Administration, given according to accepted dose schedules and ways of     taking the medicines. All diagnostic tests and treatments will be according to standard     medical practice for the disease. No experimental procedures will be offered under this     protocol.      Patients will be followed as needed for evaluation and treatment of their condition. In     general, they will be asked to return at the end of therapy, then 3, 6 and 12 months later,     and then every 6 to 12 months. More frequent visits may be required or less frequent visits     may be allowed, depending on the individual s condition.      Participants may be asked to undergo the following additional procedures for research     purposes:        -  Extra blood draws to study Lyme disease and other inflammatory conditions. Blood will be          drawn from arm veins. The total amount drawn during any 6-week period will not exceed          450 cc (30 tablespoons) for adults and 7 cc (1/2 tablespoon) per kilogram (2.2 pounds)          of body weight for children under 18 years of age.        -  Leukapheresis to collect large numbers of white blood cells. Whole blood is collected          through a needle in an arm vein, similar to donating blood. The blood circulates through          a machine that separates it into its components, and the white cells are removed. The          rest of the blood is returned to the body through the same needle. Only adults 18 years          of age and older will be asked to undergo leukapheresis.   "
167494|NCT00028093|"     This study will examine the effectiveness of pegylated interferon, or peginterferon (a     long-acting form of alpha interferon) plus ribavirin in treating hepatitis C (genotype 1)     infection with and without kidney disease.   "
167495|NCT00028106|"     This study will evaluate the effectiveness of 131MIBG in treating malignant pheochromocytoma     and whether sensitization medications improve the response to treatment. Pheochromocytoma is     a rare type of tumor that usually occurs in the adrenal glands. The tumor cells release     chemicals like adrenaline that can cause large increases in blood pressure and pulse rate,     with serious health consequences. Tumor in the adrenal glands usually can be removed     surgically, but if the pheochromocytoma is malignant-i.e., has spread to many sites in the     body-or is located in places where surgery is difficult or impossible, no satisfactory     treatment is available. 131MIBG is a combination of an adrenaline-like chemical and a     radioactive form of iodine. The 131MIBG attaches to the tumor cells and the high     concentration of radioactive iodine kills them. Previous studies using 131MIBG to treat     pheochromocytoma had a 36% response rate in terms of complete or partial improvement. This     study will examine whether adding other sensitization medications to the 131MIBG treatment     regimen will enhance its effectiveness in reducing the size and number of tumors.      Patients 18 years of age and older with malignant or inoperable pheochromocytoma may be     eligible for this 18-month study. Candidates will be screened with various tests and     procedures, which may include a medical history, physical examination, blood and urine tests,     lung function studies, electrocardiogram, echocardiogram, computed tomography (CT), magnetic     resonance imaging (MRI), positron emission tomography (PET), and bone scans and other scans     using radioactive MIBG and octreotide.      Participants will be randomly assigned to one of two treatment groups: 1) 131MIBG plus     sensitization medications, or 2) 131MIBG alone. All patients will be hospitalized 3 to 5 days     for each 131MIBG treatment. The drug will be infused through a vein (intravenously, or I.V.)     over 10 to 30 minutes. Patients will receive up to 3 treatments, separated by at least 3     months. All patients will also take potassium to protect the thyroid gland from radioactive     iodine generated by the 131MIBG. The potassium is taken twice a day for 30 days, beginning     the day before the 131MIBG treatment. Patients in the sensitization group will receive the     following additional drugs for sensitization: methylprednisolone, intravenously a few minutes     before 131MIBG treatment; Roaccutan, by mouth (capsules) twice a day for 6 weeks before     treatment; Demser, by mouth 3 times a week for 1 week before treatment, and Carbidopa, by     mouth every 6 hours for 4 days before treatment.      After each treatment, patients will have a clinical evaluation and periodic blood tests to     check for adverse side effects of radiotherapy. Follow-up visits at NIH will be scheduled at     12 and 18 months after the first 131MIBG treatment for clinical, laboratory and imaging     tests. Patients who had tumors in the lungs before treatment will have lung function tests 1,     3, and 6 months after each treatment. CT, MRI 131MIBG, and PET scanning will be done 1 week     before each treatment.      Patients who have tumors that have grown by more than 25% and none that have shrunk by more     than 50% or who have developed one or more new tumors while on 131MIBG treatment will be     taken off the study.   "
167496|NCT00028119|"     The purpose of this study is to ensure that the HIV Prevention Trials Unit (HPTU) in Pune     will be able to enroll and retain participants for 2 upcoming HPTN clinical trials.     Specifically, this study seeks to find the rate of HIV infection and follow-up among a group     of high-risk, HIV-negative non-sexworker women in Pune, as well as among HIV-discordant     couples (couples where 1 partner is HIV-infected and the other is not).      Phase III studies of HIV prevention require the participation of a large number of people at     high risk for HIV infection. It is also important that these participants continue and follow     through with the study through the extended period of follow-up. A measurement of HIV     incidence and retention rate among high-risk women and HIV-discordant couples is necessary     for upcoming HPTN trials. Taken together with the need for estimates of HIV incidence and the     need for data to ensure high retention rates, this protocol is important for the HPTN     generally and for HPTU in Pune in particular.   "
167497|NCT00028132|"     The purpose of this study is to evaluate the PMPA gel, which kills microbes, in HIV-infected     and HIV-uninfected women.      The majority of new HIV infections occur through heterosexual contact. A product that stops     or slows the replication of HIV during sexual contact is needed. At present, there are no     products that are completely effective. PMPA gel, also known as tenofovir, is an anti-microbe     agent that may fight against sexual transmission of HIV and other sexually transmitted     diseases (STDs). It is applied to the vagina and gives women the ability to control their     disease-prevention activity.   "
167498|NCT00028145|"     The purpose of this study is to collect and study clinical and laboratory information about a     pregnant or new mother and her medical care that will increase our knowledge of the best care     for HIV-infected pregnant women and their children.      The rate of transmission of HIV from mothers to their infants has gone down. Specific U.S.     Public Health Service guidelines recommend that HIV-infected pregnant women be treated with     anti-HIV therapies; but the effectiveness of treatment and safety for the mother and her     infant have not been fully examined. This study will monitor the health of women and their     infants while they receive anti-HIV therapy. Also, this study will provide information that     may be used for future studies.   "
167499|NCT00028158|"     This clinical trial will study the safety and effectiveness of an engineered herpes virus,     G207, administered directly into the brain of patients with recurrent brain cancer. G207 has     been modified from the herpes virus that causes cold sores (called herpes simplex virus type     1 or HSV-1). G207 has been designed so that it should kill tumor cells, but not harm normal     brain cells. G207 has been shown to be safe in animal testing completed to date and in     previous studies in patients with brain tumors.      This is a phase Ib/II study. In the phase Ib portion of the study, patients will receive G207     at a dose that is higher than tested in previous human studies. Patients will initially     receive 15% of the assigned dose injected directly into the brain tumor. Approximately two     days later, as much of the tumor as possible will be surgically removed, and more G207 will     be injected into the brain tumor bed. Patients will be monitored, and medical tests will be     done at specific study timepoints.      The phase II portion will begin only if there are no safety concerns in the phase Ib portion.     The goals of the phase II portion of the study are to determine the safety of G207 and to     study patient survival at six months after G207 dosing. In the phase II portion of the study,     patients will receive a single dose of G207 at the highest dose determined to be safe in the     phase Ib portion of the study. The tumor will be removed, and G207 will be injected into any     remaining tumor tissue in the brain tumor bed. Patients will be closely monitored, medical     tests will be performed at specific study visits, and survival will be evaluated.   "
167500|NCT00028171|"     Tacrolimus is a medication given to transplant patients to help prevent rejection. The     purpose of this study is to see if tacrolimus can be taken once a day instead of twice a day     in kidney transplant patients.      Transplant patients are required to take several medications to prevent rejection and to     treat complications after their transplantation. Because of the complicated dosing schedule,     it can be difficult for patients to follow their medication schedule. Taking fewer     medications less frequently may help transplant patients to better manage their drug therapy.      Tacrolimus is better absorbed in the body if it is taken in the morning than if it is taken     in the evening. This suggests that tacrolimus can be taken once every morning instead of     twice daily in order to produce appropriate drug exposure to prevent organ rejection without     increased side effects.   "
167501|NCT00028184|"     The purpose of this study is to better understand the role of the motor part of the brain in     the recovery of motor function after stroke. The motor deficits that follow a stroke are     compensated for over several months. It has been proposed that the ipsilateral motor cortex     mediates these recovery processes. The results of this study will provide fundamental     information on the role of ipsilateral M1 in recovery of motor function after chronic stroke.      A general patient evaluation will determine the location of the lesion site and assess the     degree of impairment in motor and global cognitive functioning. An assessment of motor     function will also be performed. Patients will be divided into two groups: well and poorly     recovered. An MRI (magnetic resonance imaging) scan may also be done if one has not been     performed in the past 6 months.      Two main procedures will be performed: transcranial magnetic stimulation (TMS) and test of     motor performance. In the first procedure, a metal coil surrounded by a plastic mold will be     placed on the head and electrical current will be pulsed through it. The electrical muscle     activity will be recorded through these electrodes with a computer. The second procedure     involves a reaction time test. The task will consist of reacting to a visual stimulus by     performing a voluntary movement. TMS pulses will be given before each movement. This is done     to determine whether this type of stimulation interferes with reaction time, which would     indicated that it interferes with the brain centers executing the reaction to the visual     Go-signal.      Patients with single ischemic hemispheric lesions at least 12 months after the stroke who     initially had a severe paralysis of the arm will be recruited for the study. Healthy normal     volunteers will also be included in the study. A special effort will be made to increase the     participation of women and diverse racial groups.   "
167502|NCT00028197|"     This study will use magnetic resonance imaging (MRI) to investigate how the brain controls     voluntary movements triggered by an external stimulus or self-initiated.      Registered HCMS healthy normal volunteers may participate. They will complete a questionnaire     and will have a medical history and brief physical examination.      The study consists of two parts: 1) body movement training and 2) magnetic resonance imaging,     as follows:      Part 1 - Body movement training      Participants will train to do three different body movements involving the hands and feet.     The movements will either be self-initiated or in response to a stimulus, such as a visual or     auditory trigger.      Part 2 - Magnetic resonance imaging      Participants will do one or more of the trained movements, with or without a triggering     stimulus, during MRI scanning. MRI is a diagnostic procedure that uses a magnetic field and     radio waves to produce images of brain structure and activity. For the procedure, the subject     lies on a stretcher that is moved into the scanner-a cylinder containing a strong magnet.     Earplugs are worn to protect the ears from loud thumping noises that occur with electrical     switching of radio frequency circuits. Scanning time varies from 20 minutes to 2 hours, with     most examinations lasting 1 to 1-1/2 hours. The subject can communicate with the staff person     conducting the test at all times during the scan. A device compatible with magnetic resonance     will be used to record the participant's body movements. The participant may be asked to push     buttons of the device during the tasks.   "
167503|NCT00028210|"     This study will examine whether tactile (touch) abilities at the lip are more acute in people     with upper limb amputation compared with healthy normal volunteers. People with an amputated     upper limb have an expanded brain representation of the lip that may correlate with     heightened tactile spatial acuity.      Normal volunteers will be recruited for this study. Candidates will be screened with physical     and neurological examinations. (Amputee volunteers will be studied at the amputee clinic at     the University of Tubingen, Germany.)      Participants will sit comfortably in a chair, wearing a blindfold, during the following     experiments:        -  Plastic domes with grooves are placed on parts of the lower lip on either side for a few          seconds. The volunteer is then asked to identify the direction of the grooves relative          to the long axis of the lip.        -  The participant's arm is placed in a cast and the index finger is immobilized. The same          test done on the lip is repeated on the distal part of the index finger.      Each part of the test lasts about 20 minutes, and the entire experiment takes about 2 hours.   "
167511|NCT00028327|"     Many HIV infected patients admitted to the intensive care area (ICA) have never taken     anti-HIV drugs. The purpose of this study is to learn whether starting anti-HIV drugs while     patients are in an ICA will help them to survive and get better faster. This study will also     evaluate patients who, though not in an ICA, have been admitted to the hospital for serious     illnesses or infections.   "
167512|NCT00028340|"     Background:      Breast cancer is the most common malignancy in women, occurring in over 230,000 women     annually in the United States.      The vast majority of breast cancers originate in the single layer of epithelial cells that     line the ductal/lobular system of the breast milk ducts. The premalignant changes which occur     in the transformed epithelium are not well understood, however several cytologic or     histologic changes have been identified which are associated with an increased risk for     breast cancer, including ductal or lobular hyperplasia, hyperplasia with atypia, and lobular     or ductal carcinoma in situ.      The identification of cytological or histological abnormalities in breast epithelial cells is     an important component of risk assessment.      Objectives:      The primary objectives are:      To determine the incidence and nature of cytologic changes in ductal epithelial cells from     the high risk breast, in specimens collected by breast duct lavage, and to determine if these     cytologic findings are different from those of normal women not at increased risk for breast      cancer.      To characterize by breast duct endoscopy, high risk breast ductal epithelium and     architecture, and correlate these findings with the cytologic findings from above.      To determine what is the global gene expression pattern of high risk breast epithelial cells     from the high risk breast, and does this differ from that of breast epithelial cells from     normal women not at increased risk for breast cancer. The gene expression profile will be      determined by cDNA microarray and validated by RT-PCR.      Eligibility:      Eligibility for high risk individuals will include:        -  Women of any age with a unilateral invasive or noninvasive (DCIS) breast cancer of          epithelial origin.        -  Women without breast cancer, but with a Gail Index greater than 1.67%, or a cumulative          lifetime risk greater than or equal to double the age- and race-matched general          population risk.        -  Women known to be BRCA1/2 or other hereditary genes mutation carriers.        -  Women with cytologic or histologic evidence of ductal hyperplasia, atypical ductal          hyperplasia, or lobular carcinoma in situ.        -  Women may be either premenopausal or postmenopausal. Postmenopausal is defined by the          absence of menstrual periods for at least 12 months.        -  Postmenopausal women who have previously undergone a hysterectomy without oophorectomy          must have a serum FSH level of >40 IU/ml, and a serum estradiol level of less than40          pg/ml to document postmenopausal status.      Eligibility for normal volunteers will include:        -  Women who are premenopausal or postmenopausal with a Gail model risk index less than          1.67%, and without a cumulative lifetime risk greater than or equal to double the age-          and racematched general population risk.        -  Women who have previously undergone a hysterectomy without oophorectomy must have a          serum FSH level of >40 IU/ml, and a serum estradiol level of less than 40 pg/ml to          document postmenopausal status.        -  Both breasts must be free of any suspicious areas by physical examination and, for women          over 30 years of age by mammogram. There must be no past history of atypical          hyperplasia, invasive or in situ carcinoma.      Both groups must have acceptable WBC and platelet counts.      Design:      Breast ductal epithelial cells will be collected by breast duct lavage from a.) the breast in     women at increased risk for breast cancer, and b.) the breast of female normal volunteers who     are not at increased risk for breast cancer.      Ductal epithelial cell specimens will be analyzed cytologically for the presence of     hyperplasia, atypia, or in situ changes.      Breast duct endoscopy will be performed in breast cancer patients and in normal volunteers     with cytologic atypia on ductal lavage to determine ductal architectural changes associated     with increased risk for breast cancer, and to provide correlation with cytologic atypia.      The gene expression profile of normal and high risk ductal epithelial cells will be studied     by cDNA-microarray to determine changes in gene expression associated with increased risk for     breast cancer.      Additional molecular profiling experiments which will be performed as lavage cells are     available include DNA whole exome sequencing, Comparative Genomic Hybridization (CGH),     proteomic tissue lysate arrays, and identification of mammary stem cells.      A total of 104 high risk subjects and 80 normal volunteers will be studied, divided     approximately evenly between premenopausal and postmenopausal women.   "
167613|NCT00029874|"     This is a study to determine whether treatment with minocycline is safe and tolerable in     patients with Huntington's disease (HD) and whether minocycline reduces symptoms of HD in     these patients.   "
167504|NCT00028236|"     This is a clinical trial of gene therapy for X-linked severe combined immunodeficiency     (XSCID), a genetic disease caused by defects in a protein called the common gamma chain,     which is normally on the surface of immune cells called lymphocytes. XSCID patients cannot     make T lymphocytes, and their B lymphocytes fail to make essential antibodies for fighting     infections. Without T and B lymphocytes patients develop fatal infections in infancy unless     they are rescued by a bone marrow transplant from a healthy donor. However, even transplanted     patients may achieve only partial immune recovery and still suffer from many infections,     auto-immunity and/or and poor growth. A recent, successful trial in France used gene therapy     instead of bone marrow transplantation for infants with XSCID. This experience indicates that     gene therapy can provide clinical benefit to XSCID patients. We will enroll eight older XSCID     patients (1.5-20 years-old), who have previously received at least one bone marrow     transplant, but still have poor T and B lymphocyte function that compromises their quality of     life. Before enrollment, these subjects will have had some of their own blood-forming stem     cells harvested and frozen in a blood bank. These cells have a defective gene, but a correct     copy of the gene will be inserted while the cells are grown in sterile conditions outside the     patient's body. To do this, the cells will be unfrozen and exposed for four days in a row to     growth factors and particles of a retrovirus we have constructed and tested called GALV     MFGS-gc. Retrovirus particles will attach to the patient cells and introduce a correct copy     of the common gamma chain gene into cells capable of growing into all types of blood cells,     including T and B lymphocytes. XSCID patients who are enrolled in the study will receive a     single dose of their own cells that have been modified by the GALV MFGS-gc treatment and also     will be given another drug called palifermin to help prevent side effects from the     chemotherapy and possibly try to improve the development of the T cells. After this, the     patients will be monitored to find out if the treatment is safe and to see if their immune     function improves. Study endpoints are (1) efficient and safe clinical-scale transduction of     HSC from post-BMT XSCID subjects; (2) administration of a nonmyeloablative conditioning     regimen in older patients to improve engraftment; (3) administration of a transduced HSC to     eight subjects; (4) administration of KGF to improve thymic function post transplant to     improve T cell development; and (5) appropriate follow-up of the treated subjects to monitor     vector sequence distribution, gc expression in hematopoietic lineages, and lymphoctye numbers     and function as well as general health and immune status.   "
167505|NCT00028249|"     This study will investigate the most effective approach for managing pain and providing     palliative care (lessening of pain or symptoms).      Patients with advanced cancer who are enrolled in a National Cancer Institute (NCI) protocol     and will undergo major surgery as part of their treatment may be eligible for this study.      Participants will be randomly assigned to pain management provided by either 1) their     attending physician or 2) the Clinical Center's Pain and Palliative Care Service. Patients in     the first group may be reassigned to the Pain and Palliative Care Service at any time during     the study.      Participants will be interviewed every 3 months for as long as 1 year about their pain, its     effect on several areas of their lives, changes in their needs, and how well they think their     pain is being managed.. As the patients progress through the NCI study, they will meet     regularly and as often as needed with either their attending physician or the Pain and     Palliative Care team. Each interview will last about 20 to 30 minutes. With the patient's     permission, the interviews will be tape recorded.   "
167506|NCT00028262|"     This study will examine the effectiveness of a drug called Cystagon in treating infantile     neuronal ceroid lipofuscinosis (INCL), a progressive neurological disease affecting children.     At around 11 to 13 months of age, patients develop slowed head growth, mild brain atrophy     (wasting), electroencephalographic (EEG) changes and retinal deterioration, with symptoms     worsening over time. The disease results from an enzyme deficiency that causes fatty     compounds called ceroid to accumulate in cells. In laboratory experiments, Cystagon has     helped remove ceroid from cells of patients with INCL.      Children with INCL between 6 months and 3 years of age may be eligible for this study.     Participants take Cystagon daily by mouth every 6 hours. They are admitted to the NIH     Clinical Center for a 4- to 5-day period every 6 months for the following tests and     evaluations:        -  Review of medical history, including a detailed record of seizures, physical          examination, blood tests and clinical photographs. For the initial baseline studies,          examinations may also be scheduled with pediatric neurology, ophthalmology and          anesthesia services.        -  Magnetic resonance imaging (MRI) of the brain MRI uses a powerful magnet, radio waves,          and computers to provide detailed images of the brain without the use of X-rays. The          patient lies on a table that slides inside a donut-shaped machine containing a magnetic          field. The child requires general anesthesia for the procedure.        -  Electroretinogram (ERG) measures the function of the retina, the light-sensitive tissue          in the back of the eye. To record the flash ERG, a special contact lens is placed on the          eye s surface and the eye is stimulated with flashes of light. Infants and very young          children require general anesthesia for the procedure.        -  Visual evoked potential (VEP) measures the function of the visual pathway from the eye          to the brain. To record the VEP, five electrodes are placed on the scalp and the eye is          stimulated with flashes of light. Infants and very young children must be anesthetized          for the procedure.        -  Electroencephalogram (EEG) measures brain electrical activity, using electrodes placed          on the scalp. The test is useful in defining seizures. The child may need to be sedated          to keep still during the test.        -  Skin biopsy A small piece of skin is removed (usually from the upper arm or shoulder)          under local anesthetic to grow cells in the laboratory. This procedure is done at the          start of the study and is repeated after 1 year if therapy results are promising.      Children s condition may improve, stabilize or worsen during this study. Life may be     prolonged without significant improvement in quality. The information gained from the study     may help scientists develop more potent drugs to treat INCL.   "
167507|NCT00028275|"     This study will test whether gamma interferon is effective in treating chronic hepatitis C     infection-a long-lasting viral infection affecting the liver. One-third of patients with     hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or     liver cancer. The current treatment for hepatitis C infection is pegylated alpha interferon     (peginterferon) plus ribavirin; however, this treatment is successful in only about half of     patients. Gamma interferon works similarly to alpha interferon, but through different     pathways, and therefore might be helpful in patients who do not respond to alpha interferon.      Patients 18 years of age and older with chronic hepatitis C infection, genotype 1, who did     not respond to alpha interferon and ribavirin therapy may be eligible for this study.     (Genotype 1 is a strain of hepatitis C virus that has a lower treatment success rate.)      Potential participants will be admitted to the NIH Clinical Center for 2 to 3 days for a     medical evaluation to determine eligibility for the study and, if enrolled, to begin gamma     interferon therapy. Screening will include a medical history and physical examination, blood     and urine tests, and possibly chest X-ray, abdominal ultrasound, and psychiatric evaluation.      Participants will receive injections of gamma interferon under the skin 3 times a week for 4     weeks (a total of 12 injections). They will be randomly assigned to receive either 100 or 200     micrograms of drug per injection. Blood will be drawn just before the first injection and     then 6, 12, 24 and 48 hours later to monitor changes in the levels of hepatitis C virus and     immune responses to treatment. The amount and rapidity of decrease in virus will be compared     with what occurs with alpha interferon treatment to define the relative effectiveness of     gamma interferon. (Patients may leave the hospital at any time after the first day, but must     return in time for the final blood test.)      Patients will be seen in the clinic each week during treatment to report symptoms and drug     side effects and to have blood drawn for routine tests and viral levels. After the 4-week     treatment is completed, patients will return for follow-up visits at weeks 6 and 8 for     routine blood tests.   "
167508|NCT00028288|"     The purpose of the study is to evaluate an investigational medication to treat chronic     persistent asthma. The research is being conducted at up to 22 clinical research sites in the     US and is open to both men and women ages 18 to 70 years old. Participants in the study will     have a number of visits to a research site over a 10-month period. All study-related care and     medication is provided to qualified participants at no cost: this includes all visits,     examinations and laboratory work.   "
167509|NCT00028301|"     This study will compare 2 treatments in the way they affect cholesterol levels and the amount     of HIV in the blood.   "
167510|NCT00028314|"     The goals of this study are to find out if fat wasting and weight loss in the arms and legs     of HIV patients taking highly active antiretroviral therapy (HAART) are caused by     nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and if wasting can be reversed     if the NRTI is stopped and replaced with other anti-HIV drugs.   "
167614|NCT00029900|"     This is a study to determine the safety and toxicity of increasing doses of arginine     deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic     melanoma.   "
167514|NCT00028366|"     Ritonavir (RTV) is a protease inhibitor (PI) commonly used to increase drug levels of other     PIs in HIV drug treatment. The purpose of this study is to compare a combination of drugs     which includes RTV and 2 protease inhibitors (PIs) with 2 combinations that include RTV and     another PI. This study also will compare the effectiveness, safety, tolerability, and drug     levels in the blood of these anti-HIV drug combinations.   "
167515|NCT00028379|"     Recent studies have demonstrated that electrical stimulation delivered over the skin     increases the muscle strength as measured by a dynamometer in chronic stroke patients. We     recently also found out that such stimulation enhances the ability of healthy brains to learn     faster, enhancing the beneficial effects of the motor training.      The purpose of this study is to find out if this stimulation can enhance the ability of     stroke patients to experience plastic changes in the brain. It may aid in the development of     new strategies for rehabilitation after brain injury in the future.      A clinical and neurological exam will be administered. Each patient will participate in three     different sessions separated by at least 48 hours: a 2-hour peripheral nerve stimulation to     the weak hand, a 2-hour peripheral nerve stimulation to the leg, and no stimulation. The     sessions will be randomly ordered. A magnetic resonance imaging scan of the brain will be     done as well.      Nerve stimulation will be done by transcranial magnetic stimulation (TMS). In TMS, the head     is immobilized within a frame. An insulated coil wire is placed on the scalp and brief     electrical current passed through it. Participants may be asked to perform movements, do     simple tasks, or simply tense muscles. Electrical activity of the muscles will be recorded     with a computer. Some experiments may be recorded on videotape.      Participants must be stroke patients who have recovered to the point of being able to make     thumb movements, and the stroke must have occurred more than 6 months ago.   "
167516|NCT00028405|"     This multi-center photodynamic therapy study plans to treat patients with large tumors in any     superficial location, sarcoma, tumors of oral/oro-pharyngeal cavity, tumors with extensive     pelvic involvement, or liver metastasis. The treatment is limited to patients that have     failed to respond to currently approved methods of treatment. The study involves a single,     intravenous administration of an investigational drug, LS11 (previously studied in     approximately 80 cancer patients) and the placement of a novel, flexible light delivery     catheter inside the tumor by a minor surgical procedure. The activation of LS11 by the light     delivery catheter over a period of 1-24 hrs may result in destruction of tumor tissue.   "
167517|NCT00028418|"     This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of     clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias.     Clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the     better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against     lymphoproliferative disorders. Thus, it is hoped that this drug will be more active and less     toxic than similar drugs.   "
167518|NCT00028431|"     This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail     composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's     adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV     melanoma.   "
167519|NCT00028483|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies can locate tumor cells and deliver     tumor-killing substances to them without harming normal cells. Combining chemotherapy with     monoclonal antibody therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and monoclonal     antibody therapy in treating women who have metastatic or recurrent breast cancer.   "
167520|NCT00028496|"     Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in     treating patients who have advanced or metastatic cancer. Vaccines may make the body build an     immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may     increase the number of immune cells found in bone marrow or peripheral blood. Combining     vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may     kill more tumor cells   "
167521|NCT00028509|"     RATIONALE: Assessing the effects of methotrexate on brain function in children may improve     the ability to plan treatment and decrease side effects.      PURPOSE: Clinical trial to compare brain function of children who have been previously     treated with methotrexate.   "
167522|NCT00028522|"     This phase I trial is studying the side effects and best dose of R(+)XK469 in treating     patients with advanced neuroblastoma. Drugs used in chemotherapy work in different ways to     stop cancer cells from dividing so they stop growing or die.   "
167523|NCT00028535|"     Phase I trial to study the effectiveness of interleukin-12, paclitaxel, and trastuzumab in     treating patients who have solid tumors. Interleukin-12 may kill tumor cells by stopping     blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells.     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either     kill them or deliver tumor-killing substances to them without harming normal cells. Combining     interleukin-12, chemotherapy, and monoclonal antibody therapy may kill more tumor cells.   "
167524|NCT00028548|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of XK469 in treating patients who have     advanced solid tumors.   "
167525|NCT00028561|"     This phase I trial is studying the side effects and best dose of BMS-247550 when given     together with carboplatin in treating patients with recurrent or refractory solid tumors.     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining more than one drug may kill more tumor cells   "
167621|NCT00029991|"     This study will determine if a highly standardized herbal extract of the leaves of the Ginkgo     Biloba tree will benefit patients who have pain on walking due to narrowing of the arteries     of the legs.   "
167527|NCT00028587|"     Phase I trial to study the effectiveness of combining PS-341 and combination chemotherapy in     treating patients who have advanced solid tumors. PS-341 may stop the growth of tumor cells     by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     PS-341 and chemotherapy may kill more tumor cells   "
167528|NCT00028600|"     RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor     may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor     cells. The donated stem cells may also help destroy any remaining cancer cells     (graft-versus-tumor effect).      PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant     followed by donor peripheral stem cell transplant works in treating patients with multiple     myeloma.   "
167529|NCT00028613|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver     tumor-killing substances such as radioactive iodine to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibodies in     treating patients who have large cell lymphoma that has been previously treated.   "
167530|NCT00028626|"     RATIONALE: Embolization blocks blood flow to part of an organ and/or tumor. Blocking the     portal vein on one side of the liver may cause the opposite side of the liver to increase in     size and decrease the risk of liver failure following surgery.      PURPOSE: Phase II trial to study the effectiveness of portal vein embolization in treating     patients who have liver metastases from primary colorectal cancer.   "
167531|NCT00028639|"     RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for     cancer cell growth.      PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating women who have     metastatic breast cancer.   "
167532|NCT00028652|"     RATIONALE: Inserting the gene for interleukin-12 into a person's skin tumor cells may make     the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of interleukin-12 gene therapy in treating     patients who have skin metastases.   "
167533|NCT00028665|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to     give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known if     combining rituximab with cyclophosphamide is more effective than cyclophosphamide alone in     stimulating peripheral stem cells for transplantation.      PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide with or     without rituximab followed by chemotherapy and peripheral stem cell transplantation works in     treating patients with recurrent non-Hodgkin's lymphoma.   "
167534|NCT00028678|"     RATIONALE: Dalteparin may stop the growth of cancer by stopping blood flow to the tumor and     by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy     x-rays to damage tumor cells. Combining dalteparin with radiation therapy may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of combining dalteparin with radiation     therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.   "
167535|NCT00028691|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer     cells. It is not yet known if chlorambucil is more effective than radiation therapy in     treating follicular lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of     radiation therapy in treating patients who have stage III or stage IV follicular lymphoma     that has not been previously treated.   "
167536|NCT00028704|"     RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less     invasive than mastectomy and may improve the quality of life. It is not yet known if     breast-conserving treatments are as effective as mastectomy followed by radiation therapy in     treating locally advanced breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy     with mastectomy followed by radiation therapy in treating women who have locally advanced     breast cancer that has been previously treated with chemotherapy.   "
167537|NCT00028717|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. It     is not yet known if combination chemotherapy plus filgrastim is more effective with or     without rituximab in treating non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to determine the effectiveness of combination     chemotherapy plus filgrastim with or without rituximab in treating older patients who have     non-Hodgkin's lymphoma.   "
167538|NCT00028730|"     RATIONALE: Giving chemotherapy and total body irradiation before a donor bone marrow     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor     can make an immune response against the body's normal cells. Giving antithymocyte globulin     and removing the T cells from the donor cells before transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well total-body irradiation and chemotherapy     followed by T-cell depleted donor bone marrow transplant works in treating young patients     with hematologic cancer.   "
167539|NCT00028743|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving the drugs in different     combinations may kill more tumor cells. It is not yet known which combination chemotherapy     regimen is more effective in treating ovarian epithelial, primary peritoneal, or fallopian     tube cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination     chemotherapy regimens in treating patients who have stage IIB, stage III, or stage IV ovarian     epithelial cancer , primary peritoneal cancer, or fallopian tube cancer.   "
167627|NCT00030082|"     RATIONALE: Heating melphalan to several degrees above body temperature and infusing it to the     affected area directly around the tumor may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of hepatic arterial infusion with melphalan     in treating patients who have unresectable liver cancer.   "
168026|NCT00038935|"     The purpose of this study is to determine the relative bioavailability of ReFacto AF as     compared to ReFacto, when each is administered as 2-minute bolus infusions.   "
167540|NCT00028756|"     Randomized phase III trial to compare the effectiveness of immediate adjuvant chemotherapy     with that of adjuvant chemotherapy given when the cancer returns in treating patients who     have undergone a radical cystectomy for stage III or stage IV transitional cell carcinoma of     the bladder urothelium. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die. Combining more than one drug and giving them after     surgery may kill any remaining tumor cells. It is not yet known if adjuvant chemotherapy is     more effective when given immediately after radical cystectomy (surgery to remove the     bladder) or when the cancer returns.   "
167541|NCT00028769|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs     such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from     producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone     therapy in treating patients who have metastatic prostate cancer.   "
167542|NCT00028782|"     This phase II trial is studying how well EF5 works in detecting oxygen level and blood     vessels in tumor cells of patients who are undergoing photodynamic therapy for     intraperitoneal or pleural cancer. Diagnostic procedures using EF5 to detect oxygen level and     blood vessels in tumor cells may help to improve the way photodynamic therapy is given   "
167543|NCT00028795|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Giving chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation     therapy after surgery followed by chemotherapy alone works in children with newly diagnosed     astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.   "
167544|NCT00028821|"     Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have     advanced solid tumors. 2-methoxyestradiol may stop or slow the growth of solid tumors by     stopping blood flow to the tumor   "
167545|NCT00028834|"     This phase II trial is to see if combining gemcitabine with bevacizumab works in treating     patients who have advanced pancreatic cancer. Drugs used in chemotherapy work in different     ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies,     such as bevacizumab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or deliver     cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill     more tumor cells   "
167546|NCT00028847|"     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes     necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop     cancer cells from dividing so they stop growing or die. Combining imatinib mesylate and     chemotherapy may kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate plus cytarabine in     treating patients who have newly diagnosed chronic myeloid leukemia.   "
167547|NCT00028860|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following     surgery in treating patients who have urinary tract cancer.   "
167548|NCT00028873|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining     R101933 with paclitaxel or docetaxel may reduce resistance to the drug and allow the tumor     cells to be killed.      PURPOSE: Phase II trial to study the effectiveness of combining R101933 with either     paclitaxel or docetaxel in treating patients who have metastatic breast cancer that has not     responded to previous chemotherapy.   "
167549|NCT00028886|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping     blood flow to the cancer. Peripheral blood stem cell transplant using stem cells from the     patient or a donor may be able to replace immune cells that were destroyed by chemotherapy     used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer     cells (graft-versus-tumor effect). It is not yet known whether chemotherapy followed by     peripheral blood stem cell transplant is more effective with or without thalidomide in     treating multiple myeloma.      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with     thalidomide to see how well it works compared with giving combination chemotherapy without     thalidomide in treating patients with multiple myeloma.   "
167550|NCT00028899|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from     dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can     locate cancer cells and either kill them or deliver cancer-killing substances to them without     harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may     kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with     combination chemotherapy in treating children who have relapsed or refractory acute myeloid     leukemia or myelodysplastic syndrome.   "
167551|NCT00028912|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary     for tumor cell growth. Drugs used in chemotherapy such as carboplatin use different ways to     stop tumor cells from dividing so they stop growing or die. Bortezomib may help carboplatin     kill more tumor cells by making tumor cells more sensitive to the drug.      PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with carboplatin in     treating patients who have recurrent or progressive ovarian epithelial, primary peritoneal,     or fallopian tube cancer.   "
167552|NCT00028925|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as filgrastim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or     without filgrastim in treating patients who have extensive-stage small cell lung cancer that     has not been previously treated.   "
167553|NCT00028938|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Epoetin alfa may stimulate red blood cell production and prevent or treat anemia in patients     who are undergoing radiation therapy and chemotherapy. It is not yet known if chemotherapy     combined with radiation therapy is more effective with or without epoetin alfa in treating     non-small cell lung cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of chemotherapy combined     with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA     or stage IIIB non-small cell lung cancer.   "
167554|NCT00028951|"     RATIONALE: Fibrin sealant may decrease lymphedema following surgery to remove lymph nodes in     the groin by helping to seal the lymphatic vessels. It is not yet known if fibrin sealant is     effective in decreasing lymphedema following surgery to remove lymph nodes.      PURPOSE: Randomized phase III trial to determine the effectiveness of fibrin sealant in     reducing lymphedema following surgical removal of lymph nodes in patients who have cancer of     the vulva.   "
167555|NCT00028964|"     RATIONALE: Herbs used in traditional Chinese medicine may decrease the side effects of     chemotherapy.      PURPOSE: Randomized phase I/II trial to study the effectiveness of herbs used in traditional     Chinese medicine in decreasing the side effects of chemotherapy after surgery in women who     have stage I, stage II, or early stage III breast cancer.   "
167556|NCT00028977|"     RATIONALE: The Chinese herb Scutellaria barbata contains ingredients that may slow the growth     of cancer cells and may be an effective treatment for metastatic breast cancer.      PURPOSE: Phase I/II trial to study the effectiveness of Scutellaria barbata in treating women     who have metastatic breast cancer.   "
167557|NCT00028990|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as     bevacizumab, can block cancer growth in different ways. Some block the ability of cancer     cells to grow and spread. Others find cancer cells and help kill them or deliver     cancer-killing substances to them. It is not yet known whether paclitaxel works better with     or without bevacizumab in treating breast cancer.      PURPOSE: This randomized phase III trial is to see if paclitaxel works better with or without     bevacizumab in treating patients who have locally recurrent or metastatic breast cancer.   "
167558|NCT00029003|"     Phase II trial to study the effectiveness of gefitinib in treating patients who have stage     IIIB or stage IV non-small cell lung cancer. Biological therapies such as gefitinib may     interfere with the growth of the tumor cells and slow the growth of non-small cell lung     cancer   "
167559|NCT00029029|"     RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells     and may help to relieve pain caused by bone metastases.      PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in relieving     pain in patients who have bone metastases.   "
167560|NCT00029042|"     This study will determine whether a stepwise increase of the drug infliximab (Remicade®     (Registered Trademark)) controls juvenile rheumatoid arthritis more effectively than a fixed     dose. It will look at the safety and effectiveness of increasing the dose to a maximum of     15mg/kg body weight per dose, examining the drug's effect on bone and cartilage, and whether     it can improve abnormal growth, metabolism and hormones. Infliximab is approved for treating     adults with rheumatoid arthritis and Crohn's disease.      Children between 4 and 17 years of age with active juvenile rheumatoid arthritis who do not     respond adequately to standard therapy may be eligible for this study.      Participants will receive nine infusions of infliximab during this 62-week study. The drug is     given intravenously (IV, into a vein) over 2 hours. The first three infusions will be at a     dose of 5 mg/kg of body weight. Children who improve on this regimen will receive another 6     infusions at the same dose. Children who do not significantly improve on 5 mg/kg at the end     of 6 weeks (the third infusion) may continue with phase 2 of the study, in which they will be     randomly assigned to receive either: 1) 6 additional doses of the drug at 5 mg/kg per dose,     or 2) a gradually increased dose to a maximum of 15 mg/kg. In addition, all children will     continue to take methotrexate at the same dose as when they entered the study.      Participants will visit the NIH Clinical Center 12 times (about every 8 weeks) during the     study for the following tests and procedures:        -  History and physical examination, including a complete joint exam        -  Puberty assessment - breast development in girls, testicle size in boys, and pubic hair        -  Height and weight measurements      Children will have imaging studies (x-rays, MRI and Dexa scan) at the beginning and end of     the study and will collect a 24-hour urine sample before each infliximab infusion.      Patients may elect to have an endocrine evaluation. This involves Clinical Center     hospitalizations for 1-1/2 days on visits 1, 4 and 12. Small amounts of blood will be drawn     every 20 minutes (through an indwelling catheter to avoid multiple needle sticks) for 8 hours     while the child sleeps. The blood will be examined for the normal rhythm of growth hormone     and other substances in the body and how they are affected by arthritis.      Participants will complete a questionnaire once a year for 2 years to provide information on     their health status and any problems that might be related to the study drug.   "
167561|NCT00029068|"     This study will use transcranial magnetic stimulation (TMS) to study the function of the     cerebral cortex (outer layer of the brain) in people with obsessive compulsive disorder (OCD)     and related disorders. A non-invasive procedure, TMS activates areas of the brain with     magnetic pulses that travel through the scalp and head and cause small electrical currents in     the brain.      People 18 years of age and older with OCD and disorders that may be related-tic disorders,     such as Tourette's syndrome, focal dystonia (localized muscle cramps), body dysmorphic     disorder (hypersensitivity to changes in appearance), eating disorders, such as anorexia     nervosa, trichotillomania (compulsive hair-pulling)-may be eligible for this study. Healthy     normal volunteers will also be enrolled. Candidates will be screened by telephone interview.      Participants will undergo TMS. For this procedure, an insulated wire coil is placed on the     subject's head. A brief electrical current passes through the coil, creating a magnetic pulse     that travels through the scalp and skull and causes small electrical currents in the outer     part of the brain. The stimulation may cause muscle, hand or arm twitching, or may affect     movement or reflexes. During the stimulation, the subject may be asked to tense certain     muscles slightly or perform other simple actions. The electrical activity of muscles during     stimulation is recorded with a computer or other recording device, using electrodes attached     to the skin with tape.      Subjects will receive fewer than 500 magnetic pulses, and the study will take less than 3     hours. Participants may repeat the procedure on several occasions, if they agree.   "
167622|NCT00030004|"     This study is designed to determine whether a medicine that can produce temporary amnesia     (midazolam) can be used to block the memory of treatment with spinal manipulation. This is     important since any study that is designed to determine whether spinal manipulation is     effective would be better if patients were not aware of whether or not they were treated.     This would allow a true assessment of treatment effects without the complication of a strong     placebo effect that manipulative treatment may produce.   "
167562|NCT00029107|"     The purpose of this study is to assess the efficacy of Rituximab (anti-CD20) in the treatment     of patients with hepatitis C associated cryoglobulinemic vasculitis (HCV-CV) who have failed     or are intolerant to interferon-alpha/ribavirin therapy. Up to 75 patients may be screened to     enroll 34 adult patients with active HCV-CV in this randomized, non-blinded phase I/II trial.     Patients will be randomized to receive either Rituximab 375 mg/M(2) on days 1, 8, 15 and 22     beginning at the time of enrollment or standard therapy. Patients in both groups will be     maintained on stable doses of any immunosuppressive therapies that they were receiving at the     time of enrollment. Response to Rituximab will be assessed by clinical and laboratory     parameters.      Although the cause of cryoglobulinemic vasculitis is not known, a critical component is the     presence of cryoglobulins-abnormal proteins that white blood cells called B lymphocytes     produce in response to the chronic hepatitis C infection. Rituximab decreases the number of B     cells. The Food and Drug Administration approved Rituximab in 1997 for the treatment of     B-cell non-Hodgkin's lymphoma.      Patients between 18 and 75 years of age with hepatitis C and signs and symptoms of     cryoglobulinemic vasculitis may be eligible for this study. They must have failed, or been     unable to tolerate, treatment with IFN-a and ribavirin. Candidates will be screened with a     history and physical examination, electrocardiogram (ECG), blood and urine tests, 24-hour     urine collection and chest X-ray, if clinically indicated.      Participants will be randomly assigned to receive Rituximab upon entering the study or 6     months after entering the study. Those whose treatment is delayed 6 months will be followed     once a month at NIH for disease evaluation and blood tests during that time.      Patients will be given Rituximab intravenously (through a vein) once a week for 4 weeks. For     the first dose, patients will be admitted to the hospital for at least 24 hours after the     infusion for monitoring. Subsequent infusions will be given on an inpatient or outpatient     basis, depending on how the infusion is tolerated. The day before each infusion they will     have a history and physical examination, blood work, and other tests, such as X-rays, as     clinically indicated.      After the four infusions, patients will be followed for drug side effects and response to     treatment. They will have blood tests every week for 4 weeks and will then return to NIH for     1 day every month for 12 months for a physical examination, blood tests, and X-rays, if     medically indicated. Visits may be more frequent, if necessary, and patients may be asked to     stay longer than a day if test findings requ...   "
167563|NCT00029120|"     The purpose of this study is to examine how a part of the brain called the hippocampus     contributes to memory changes that occur with aging and Alzheimer's disease (AD).      Memory problems are the most important early symptoms of AD. The hippocampal region of the     brain may be responsible for many age- and AD-related memory disorders. This study will use     magnetic resonance imaging (MRI) scans to examine the structure, chemical composition, and     function of the hippocampus in participants with AD, participants with mild memory problems,     participants who are healthy but are at risk for AD, and healthy volunteers.      Participants in this study will undergo MRI scans of the brain. During the MRI, participants     will perform memory tests to demonstrate hippocampal functioning.   "
167564|NCT00029133|"     This is a large multi-center, prospective, randomized trial designed to determine whether     mild intraoperative hypothermia results in improved neurological outcome in patients with an     acute subarachnoid hemorrhage (SAH) who are undergoing an open craniotomy to clip their     aneurysms.   "
167565|NCT00029146|"     The purpose of this study is to determine if extracranial-intracranial bypass surgery when     added to best medical therapy can reduce the subsequent risk of ipsilateral stroke in     high-risk patients with recently symptomatic carotid occlusion and increased cerebral oxygen     extraction fraction measured by positron emission tomography (PET).   "
167566|NCT00029159|"     The purposes of this study are to learn whether treatment with an androgen type hormone will     improve the visual-spatial problems associated with Turner syndrome, and to evaluate the     effect growth hormone, with and without androgen, has on growth.   "
167567|NCT00029172|"     The purpose of this study is to evaluate a program of education, medicine, and monitoring for     the treatment of depression after a stroke.   "
167568|NCT00029185|"     This is a compassionate-use treatment study to provide Dehydrex to patients with corneal     erosion syndrome who have previously used Dehydrex.   "
167569|NCT00029198|"     The specific aims of this study are: 1) to replicate the data that following ten days of     massage therapy, preterm infants show greater daily weight gain and are discharged from the     hospital earlier than the controls, thus demonstrating the cost-effectiveness of the     intervention; 2) to test a model on two potential underlying mechanisms for weight gain     including a) enhanced vagal activity leading to greater gastric motility, higher levels of     insulin, IGF-1, and oxytocin and lower cortisol levels in the massage versus the control     infants at the end of the study; and/or b) increased physical activity and its associated     increase in heart rate oxygen consumption and temperature leading to greater weight gain.     These pathways (vagal activity and physical activity) will be tested by path analyses.     Determining underlying mechanisms for the massage therapy/weight gain relationship is a     critical process required by the neonatology community for massage therapy to be adopted as a     standard neonatal intensive care unit.   "
167570|NCT00029211|"     This is a randomized trial to determine if echinacea is effective in shortening the length     and/or lessening the severity of colds in children 2 through 11 years old.   "
167571|NCT00029224|"     Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or     prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be     evaluated, as well as time in chair, quality of life and safety of Zometa.   "
167572|NCT00029237|"     The overall purpose of the proposed study is to determine whether three short-term stress     management interventions along with booster strategies will improve and sustain improvements     in psychosocial functioning, quality of life, and somatic health among persons with varying     stages of HIV disease. The 10-week group interventions are designed to reduce perceived     stress and increase coping effectiveness and include cognitive-behavioral stress management     focused on positively living (+LIVE), focused Tai Chi (TCHI) training, and spiritual growth     groups (SPRT). Effects of the interventions will be evaluated immediately upon completion of     the group training and at 6 months and 12 months following stress management training.   "
167573|NCT00029250|"     The purpose of this study is to test the effectiveness and tolerability of garlic pills in     lowering cholesterol and triglycerides in hyperlipidemic HIV-infected individuals who are     being treated with highly active antiretroviral therapy (HAART).   "
167574|NCT00029263|"     The purpose of this study is to detect potential herb-drug interactions in volunteers.   "
167575|NCT00029276|"     During transcranial magnetic stimulation (TMS), a magnetic coil is placed on the front part     of the head. Electric current passes through the coil in brief pulses. Magnetism from the     current produces a separate, small electric current inside the brain, which activates brain     cells below the coil. This treatment may result in decreased depression and improved     Parkinson's disease symptoms.   "
167576|NCT00029289|"     Phase I/II double-masked, randomized, placebo-controlled, cross-over trial to determine     effects of lutein on vision in retinitis pigmentosa, including safety and effective dosage     assessment   "
167577|NCT00029302|"     This study will use magnetic resonance imaging (MRI) to investigate how the brain controls     bimanual movements (movements of both hands).      Healthy normal volunteers between 21 and 65 years of age may be eligible for this study.      Participants will have a medical history, physical and neurological examinations, and will     complete a questionnaire before and after testing. The study consists of two parts: 1) finger     movement training and 2) magnetic resonance imaging, as follows:      Part 1 - Finger movement training      Participants will train to do three different finger movements using the index finger of both     hands. The fingers will be taped to a device that measures their movement. The movements are:        -  Lifting and dropping the index fingers of each hand repetitively and in synchrony          (starting and stopping at the same time). The amplitude of finger movements is the same          for both hands.        -  Lifting and dropping the index fingers of each hand repetitively and in synchrony, but          with a different amplitude for each hand.        -  Lifting and dropping of the index finger of each hand repetitively, but each with a          different amplitude and not in synchrony.      Part 2 - Magnetic resonance imaging      Participants will perform the trained movements during MRI scanning. This diagnostic     procedure uses a magnetic field and radio waves to produce images of brain structure and     activity. For MRI, the subject lies on a stretcher that is moved into the scanner-a cylinder     containing a strong magnet. Earplugs are worn to protect the ears from loud thumping noises     that occur with electrical switching of radio frequency circuits. Scanning time varies from     20 minutes to 2 hours, with most examinations lasting 1 to 1 1/2 hours. The subject can     communicate with the staff person conducting the test at all times during the scan.   "
167578|NCT00029315|"     This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized     in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to     dissolve blood, and may allow intraventricular catheters to be more effective for a longer     period of time.   "
167579|NCT00029328|"     The purpose of this study is to determine the effects of etanercept, and define the toxicity,     when administered to patients with acute non-infectious lung injury (idiopathic pneumonia     syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell     transplantation.   "
167580|NCT00029341|"     The purpose of this study is to find out if anti-HIV drugs can be stopped without the virus     becoming resistant to the drugs. The study will also examine how fast anti-HIV drugs leave     the body.      Not all HIV-infected patients may require continuous and indefinite anti-HIV therapy. There     is evidence that stopping anti-HIV therapy will not make the virus resistant to efavirenz     (EFV), an anti-HIV drug that remains in the body longer than most treatment drugs. In another     study, patients were treated with EFV, zidovudine (ZDV), and lamivudine (3TC). The patients'     virus was controlled despite the fact that some patients missed medication dosages. Many     patients stop anti-HIV therapy because of negative effects. This study will examine the     body's ability to fight and control virus in patients who stop therapy.   "
167581|NCT00029380|"     This study will develop a national cord blood bank for siblings of patients with     hemoglobinopathies and thalassemia.   "
167582|NCT00029393|"     To investigate a modified hematopoeitic cell transplantation (HCT) procedure for sickle cell     disease that significantly reduces the toxicity of HCT, yet retains its therapeutic benefit.   "
167583|NCT00029406|"     To conduct a prospective study of pediatric transfusion recipients to determine the risk of     transmitting various infectious agents by blood transfusion.   "
167584|NCT00029445|"     This study will collect white blood cells and plasma for research on how the immune system     controls HIV infection. The immune system of a very small group of HIV-infected patients,     called non-progressors, has been able to control HIV for long periods without antiretroviral     therapy. Some immune system-related genes important for this control have been identified in     these patients. This study will examine the contribution of HLA genes B*57+, B*27+ and A*01+     to HIV disease in progressors and long-term non-progressors. (HLA type is a genetic marker of     the immune system.)      HIV-infected patients 18 years of age and older with HLA types B*57+, B*27+ and/or A*01+ may     be eligible for this study.      Participants will undergo apheresis-a method for collecting larger quantities of certain     blood components than can safely be collected through a simple blood draw-by one of the     following two methods:        -  Automated pheresis - Blood is drawn through a needle placed in an arm vein and spun in a          machine, separating the blood components. The white cells are extracted and the red          cells, with or without plasma (liquid part of the blood), are re-infused into the donor          through the same needle or a needle in the other arm. An anticoagulant (medication to          prevent blood from clotting) is usually added to the blood while in the machine to          prevent it from clotting during processing.        -  Manual pheresis - One unit (1 pint) of blood is drawn through a needle placed in an arm          vein, similar to donating a pint of whole blood. The red blood cells, with or without          plasma, are separated from the rest of the blood and re-infused to the donor through the          same needle. Manual pheresis will be done only when a person s estimated total blood          volume or red cell count is too low to safely permit removal of blood through a pheresis          machine. An adult small in size or markedly anemic, for example, may fall into this          category.      Some of the blood collected through apheresis may be stored for future studies of HIV disease     and immune function and for HLA testing, a genetic test of markers of the immune system. Some     of the blood may be used to screen for different types of viral liver infections, such as     hepatitis A, B, C, D, E, F, or G.   "
167585|NCT00029458|"     The purpose of this study is to evaluate the safety and effectiveness of clozapine as a     treatment for the manic phase of bipolar disorder.      A significant proportion of manic patients either do not respond adequately to conventional     treatment or cannot tolerate the adverse effects associated with therapeutic doses of these     agents. Clozapine may be a safe and effective treatment for mania. However, the efficacy of     clozapine as an alternative therapy in treatment-resistant bipolar disorder mania has not     been extensively researched.      The study will be conducted in three phases. Phase 1 is a screening phase that will take     place for 2 to 7 days. Participants will undergo a baseline positron emission tomography     (PET) scan of the brain at the end of this period. In Phase 2, participants will be randomly     assigned to receive either clozapine or placebo (an inactive pill) for 3 weeks. They may also     receive lorazepam for the first 10 days of Phase 2. After 3 weeks, patients treated with     clozapine will undergo a second PET scan. During Phase 3, participants who received placebo     and did not improve will be offered clozapine for 3 weeks. Those who received clozapine and     did not improve will receive other treatment for 3 weeks. At the end of Phase 3, participants     who were treated with clozapine will have another PET scan.   "
167586|NCT00029484|"     A randomized control trial testing whether a relaxation response based intervention, Tai Chi     Chih, will affect Varicella Zoster Virus (VZV) specific immunity measures of psychological     adaptation and health function in the older adult.   "
167587|NCT00029497|"     This study investigates the role of two active interventions and their placebo effects in     randomized control trials. The study conducts two parallel trials of treatments for upper     extremity pain secondary to repetitive stress disorder, including carpal tunnel syndrome. The     active interventions are amitriptyline and acupuncture. The placebo are sham acupuncture     device and placebo pill.   "
167588|NCT00029510|"     Asthma currently affects an estimated 15 million Americans. A number of studies have found an     association between low dietary magnesium (Mg) intake and increased asthma incidence and     severity of symptoms. However, clinical intervention trials are necessary to directly assess     whether there is a true protective or preventative causal relationship between low Mg and     asthma. In our study, we will assess the effects of 6 1/2 months of oral Mg supplements or     placebo on clinical markers of asthma control, indirect biomarkers of inflammation, bronchial     hyperresponsiveness, and indices of oxidative defense and damage in subjects with mild to     moderate persistent asthma.   "
167591|NCT00029575|"     This study will compare four methods of imaging arteries:        -  angiography (x-ray picture)        -  intravascular ultrasound (ultrasound from inside the artery)        -  magnetic resonance imaging (MRI) from outside the body        -  MRI using an antenna to take pictures inside the arteries of the pelvis      Standard angiography shows blockages inside the artery, but does not provide any information     about the arterial wall itself. New ways of looking at the artery walls with MRI and     ultrasound may provide insight into how arteries cause disease.      Patients 21 years of age and older who require catheterization and angiography of the heart,     kidney, or leg arteries because of atherosclerosis (narrowing of the arteries), may be     eligible for this study. Participants will undergo MRI and intravascular ultrasound of the     arteries immediately after their catheterization and angiography. The additional imaging will     add from 1 to 2 hours to the angiogram procedure.        -  Angiography: Using the sheaths already in place in the groin artery, catheters (flexible          plastic tubes) are placed inside the arteries in order to inject a contrast dye to take          x-ray pictures. (Patients who had an angiogram of the leg artery as part of their          medical care will not repeat this test.)        -  Intravascular ultrasound: An anti-clotting drug called heparin is given through a vein          to prevent clot formation. Blood samples are taken during the test to see if more          heparin is needed. Special wires are used to guide the catheters to the proper location          inside the arteries. A special ultrasound catheter is advanced over one of these wires          to the large artery that supplies blood to the legs. X-rays are used to help the          physician place the ultrasound in the correct location to take ultrasound pictures of          the artery wall.        -  Magnetic resonance imaging: A special MRI catheter is advanced through the catheter in          the groin. With the catheter in place, the patient is carried to a stretcher and moved          into a long metal cylinder (the MRI scanner) for imaging. During the scanning, a          contrast drug called gadolinium is injected into an arm vein to brighten the images. The          patient is able to speak through a microphone at all times to the person taking the          pictures.   "
167592|NCT00029588|"     This study will examine and compare brain changes during decision-making in healthy     adolescents and adolescents who are anxious or depressed. The findings may provide a better     understanding of mechanisms that lead to depression or anxiety.      Adolescents between 9 and 17 years of age and adults between 20 and 40 years of age in the     following categories will be enrolled in this study:        -  Healthy adults        -  Healthy adolescents        -  Adolescents with major depression        -  Adolescents with anxiety disorder (generalized anxiety disorder, social phobia, or/and          separation anxiety disorder)      The study involves three visits, as follows:      Visit 1      Visit 1 consists of three parts for both child and adult participants:        -  Part 1: Staff will meet with participants for a standard psychiatric interview, which          will include questions about the participants feelings, experiences and behavior both          past and present. For adolescent participants, staff will meet with the child alone, the          parent alone, and the child and parent together.        -  Part 2: Participants will perform a series of simple tasks involving shapes, letters,          and numbers. They will have a medical history, physical examination and blood draw. In          addition, adolescents will have a urine drug test.        -  Part 3: Adults and those adolescents who will undergo magnetic resonance imaging (MRI)          in Visit 3 will receive training to familiarize them with the procedure.      Visit 2        -  Adolescents will again be asked standardized questions regarding their feelings,          experiences and behavior, and will then perform a series of simple decision-making tasks          on a computer.        -  Adults will undergo MRI scanning, as described below in Visit 3 for adolescents. This          concludes the participation of adults in the study.      Visit 3      Adolescents will have one of the following two procedures:      - Decision-making task using a computer. Small electrodes will be placed on the child s     wrists, face and fingers to monitor muscle tone and skin humidity during the task.      Or        -  MRI, a test that uses a strong magnetic field and radio waves to show changes in brain          function. During the scan, the participant lies on a table in a space enclosed by a          metal cylinder (the MRI scanner). The procedure takes 60-90 minutes; subjects must lie          still for 10-15 minutes at a time. During imaging, the subject will be asked to perform          a decision-making task on a computer.   "
167593|NCT00029601|"     This study will use transcranial magnetic stimulation (TMS) to examine how the brain controls     muscle movement in dystonia. Dystonia is a movement disorder in which involuntary muscle     contractions cause uncontrolled twisting and repetitive movement or abnormal postures.     Dystonia may be focal, involving just one region of the body, such as the hand, neck or face.     Focal dystonia usually begins in adulthood. Generalized dystonia, on the other hand,     generally begins in childhood or adolescence. Symptoms begin in one area and then become more     widespread.      Healthy normal volunteers and patients with focal [or generalized] dystonia [between 21 and     65 years of age] may be eligible for this study.      Participants will have transcranial magnetic stimulation. For this test, subjects are seated     in a comfortable chair, with their hands placed on a pillow on their lap. An insulated wire     coil is placed on the scalp. A brief electrical current is passed through the coil, creating     a magnetic pulse that stimulates the brain. (This may cause muscle, hand or arm twitching if     the coil is near the part of the brain that controls movement, or it may induce twitches or     transient tingling in the forearm, head or face muscles.) During the stimulation, subjects     will be asked to either keep their hand relaxed or move a certain part of the hand in     response to a loud beep or visual cue. Metal electrodes will be taped to the skin over the     muscle for computer recording of the electrical activity of the hand and arm muscles     activated by the stimulation.      There are three parts to the study, each lasting 2-3 hours and each performed on a separate     day.   "
167594|NCT00029614|"     The purpose of this study is to compare the effectiveness and safety of atomoxetine in the     treatment of adolescents with coexisting alcohol or substance use disorders and Attention     Deficit Hyperactivity Disorder (ADHD).   "
167595|NCT00029627|"     The purpose of this study is to investigate the role of brain receptors called     alpha2-adrenoreceptors in regulating the sympathetic nervous system, which maintains the     supply of blood and fuel to the body's organs in times of stress, fear, anger, or exercise.      Alpha(2)-adrenergic receptors (alpha(2)-AR) play a role in a variety of physiological     functions. There are three subtypes of alpha(2)-ARs, and their differences are unknown. This     study will examine the functional roles of these three subtypes by comparing the behavioral,     biochemical, psychophysiological, and autonomic function effects of the alpha(2)-AR drugs     clonidine and yohimbine.      Participants in this study will undergo a physical examination, electrocardiogram (ECG), and     blood, urine, and saliva tests. Women will have hormone tests to determine the time of their     last period and the time of their next ovulation. Participants will undergo     neuropsychological testing and other procedures.   "
167596|NCT00029640|"     This study seeks to learn about brain function in adolescents with depression and to     determine whether adding lithium carbonate to antidepressant medication can reduce depression     in children and adolescents. Functional magnetic resonance imaging (fMRI) and magnetic     resonance spectroscopy (MRS) will examine brain chemistry and function.   "
167597|NCT00029653|"     This study will use transcranial magnetic stimulation (TMS) to investigate how the brain     controls movement by sending messages to the spinal cord and muscles.      Healthy normal volunteers 21 years of age or older may participate in this study.      They must have no medical, neurological or psychiatric illnesses nor have been taking     medications that affect nervous system function.      Participants will undergo transcranial magnetic stimulation. For this procedure, an insulated     wire coil is placed on the scalp or skin. A brief electrical current is passed through the     coil, creating a magnetic pulse that stimulates the brain. If the coil is placed over a nerve     or area of the brain that controls muscles, it may cause a muscle twitch, possibly strong     enough to move the limb. In other cases, the subject may have a feeling of movement or feel a     tingling sensation in a limb. Stimulation over the muscles on the side of the head may cause     some discomfort in that area or twitching of the jaw.      During the stimulation, the subject may be asked to tense certain muscles slightly or perform     other simple actions. The electrical activity of the muscles activated by the stimulation     will be recorded using metal electrodes taped to the skin over the muscle. In most cases, the     study takes less than 3 hours.   "
167598|NCT00029666|"     This study will examine the effects of repetitive transcranial magnetic stimulation (rTMS) on     Parkinson's disease symptoms. rTMS is a way of stimulating the brain that may be able to     change the electrical activity of the nerve cells in the brain. It has been proposed as a     treatment for brain disorders, including Parkinson's disease. In preliminary studies, some     patients' symptoms improved; in some they worsened temporarily, and some showed no change.      Patients between 40 and 80 years of age with moderately severe Parkinson's disease, whose     main problem is slowness of movement and stiffness, may be eligible for this study.      Participants will be randomly assigned to one of two treatment groups: one will receive rTMS     to parts of the brain involved in controlling movement; the other will receive sham, or     placebo, stimulation. Nine treatments will be given over a 4-1/2 week period. Patients will     take their Parkinson's disease medications during the study, but will stop taking the     medicines for 4 to 5 hours before one of the sessions.      For rTMS, an insulated wire coil is placed on the scalp. A brief electrical current is passed     through the coil, creating a magnetic pulse that stimulates the brain. The pulses are     delivered in trains, or short bursts, lasting 1 second each. There will be 48 trains for a     total of 1200 pulses per 24-minute session. The stimulation may cause muscle twitching in the     scalp or face and may also cause small movements of the limbs.      Just before and after each rTMS session, patients will have a neurologic examination,     including an evaluation of walking. Their motor function tests will be recorded on videotape     to document possible improvement and to allow physicians to rate the improvement. The     physicians will not know which patients are receiving actual rTMS and which are receiving     sham treatment. Ratings before the first and after the last rTMS sessions will be more     detailed.   "
167599|NCT00029679|"     This study will assess clinical efficacy and/or adverse effects of dietary borage oil (which     contains gamma-linolenic acid [GLA]) and Ginkgo biloba in patients with mild persistent to     moderate asthma.   "
167600|NCT00029692|"     This study will assess the effects of ginseng and ginkgo on 1) cognitive function, 2) enzymes     that process drugs, and 3) enzymes that may help prevent cancer.   "
167601|NCT00029718|"     This study will use transcranial magnetic stimulation (TMS) to identify interactions between     the unaffected and affected side of the brain in stroke patients. Results from previous     studies suggest that after a stroke, the motor cortex (part of the brain that controls     movement) of the unaffected side of the brain might negatively influence the motor cortex of     the affected side. TMS is a procedure that delivers brief electrical currents that stimulate     the brain. Studies of a small number of patients have shown that TMS can cause a temporary     decrease in activity of the motor cortex.      Healthy normal volunteers and chronic stroke patients may be eligible for this study.     Subjects may participate in up to four sessions of reaction time (speed of motor response)     testing. They will perform a series of movements with the index and middle fingers of either     the left or right hand in response to a signal from a computer monitor. The time it takes to     do the tasks will be measured and scored. There will be rest periods during each session.      TMS will be done each session to examine how the motor cortex affects recovery of function     after stroke. For this procedure, an insulated wire coil is placed on the scalp. A brief     electrical current is passed through the coil, creating a magnetic pulse that stimulates the     brain. Depending on where the coil is placed, the stimulation may cause a muscle twitch     (sometimes strong enough to move the limb), a feeling of movement or tingling in a limb, or     twitching of the jaw. During stimulation, the subject may be asked to tense certain muscles     slightly or to perform other simple actions. The electrical activity in the muscles activated     by the stimulation will be recorded using metal electrodes taped to the skin over the     muscles.      Subjects will also be asked to draw a mark on a line on paper to rate their attention and     level of fatigue, and how well they think they are executing the tasks.      Participants will also have magnetic resonance imaging (MRI). This procedure uses a strong     magnetic field and radio waves to provide detailed images of the brain. During the scanning,     the subject wears earplugs to muffle loud thumping sounds that occur with electrical     switching of the radio frequency circuits. The subject can communicate with the staff member     performing the study at all times through an intercom system.   "
167602|NCT00029731|"     This is a study to determine if oral arginine will increase nitric oxide in sickle cell     disease (SCD) patients with acute chest syndrome (ACS). It will also assess the effects of     arginine in the body and how the body uses nitric oxide in ACS.   "
167603|NCT00029744|"     The purpose of this study is to determine the ability of HVTN sites to recruit and retain     people at risk for HIV infection for possible future HIV vaccine research studies. This study     also aims to learn more about the risk behaviors of people at high risk for HIV infection.      In order for studies to be successful, study sites must be able to recruit, enroll, retain,     and inform groups at high risk for HIV infection. The plan for Phase III HIV vaccine trials     will depend on the number of participants enrolled, the rate at which participants become     HIV-infected, the length of follow-up, and the number of participants who continue and follow     through with the entire study. At existing sites, it is necessary to evaluate the potential     to recruit new groups. At possible expansion sites, work is necessary to establish effective     procedures to recruit and retain participants and to identify HIV incidence rates. This study     will accomplish those goals.   "
167604|NCT00029757|"     Background: The use of estrogen in postmenopausal (or surgically menopausal) women is a     common practice. Compliance is problematic in that estimates show only 1/3 of women use     hormone replacement therapy (HRT) and only 30% are compliant. Estrogen has many documented     benefits including symptomatic relief of hot flashes, improvement of the dry vagina and     dyspareunia. Estrogen has been found to improve bone mineral density and increase the high-     density lipoprotein portion of a cholesterol panel. To improve compliance and to provide an     alternate method of delivery, we propose the use of estrogen which is admixed in toothpaste     and propose to study the absorption, rate of build-up and rate of decline.      Hypothesis: Estrogen can potentially be absorbed systemically when toothpaste is admixed with     estradiol and is applied in a timed, consistent fashion to postmenopausal or surgically     postmenopausal women, not on HRT. Absorption takes place across the buccal mucosa.      Specific Aims:1) To estimate the systemic absorption of estrogen from daily use of estrogen     containing toothpaste.      2) To estimate the rate of build-up of serum estrogen levels based upon daily use of     toothpaste containing estrogen for eight days.      3) To estimate the rate of decline in serum estrogen levels when the use of estrogen     containing toothpaste is discontinued for a week.   "
167605|NCT00029770|"     This study will compare the effectiveness of chiropractic care, medications, and self-care on     neck pain, a very common condition. The broad, long-term objective of this study is to     identify effective therapies for neck pain sufferers and to increase understanding of neck     pain conditions.   "
167606|NCT00029783|"     This study will assess whether distant healing effects survival time and loss of function for     glioblastoma patients.   "
167607|NCT00029796|"     This is a randomized, double-blinded dietary intervention in hemodialysis patients to     determine the clinical and metabolic effects of soy isoflavones on disease activity,     including improvement of blood markers of acute-phase response, and decreased blood levels of     markers of metabolic bone disease.   "
167608|NCT00029809|"     This study will compare the effects of two Chinese and one Western exercise modalities on the     signs and symptoms of Parkinson's disease.   "
167609|NCT00029822|"     A study to determine the effect on prevention of Acute Urinary Retention (inability to     urinate) in males with an enlarged prostate, also known as BPH.        -  Free study-related medical care provided.   "
167610|NCT00029835|"     To assess the effect on weight loss and weight maintenance over a period of one year when     prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia   "
167615|NCT00029913|"     Despite risk reduction counseling, some individuals in HIV vaccine trials or vaccine     preparedness studies may engage in risk behavior that results in HIV infection. The purpose     of the HVTN 403 study is to find out more about how persons respond to HIV infection if they     have received an experimental HIV-1 vaccine before they became HIV infected.      Some people in HVTN 403 received an experimental HIV vaccine as a participant in a clinical     trial before getting infected with HIV. Other people in this study were in a vaccine     preparedness study when they got infected with HIV. None of these individuals became infected     with HIV as result of their participation in an HIV vaccine or vaccine preparedness study.     HVTN 403 will compare immune responses between those who previously received an experimental     HIV vaccine and those who did not. Information learned from this study may be important in     guiding future developments of new HIV vaccines and other treatments for HIV and AIDS.   "
167616|NCT00029926|"     This study will examine whether PET imaging can reveal what is happening in lymph nodes of     patients with systemic lupus erythematosus, or lupus, during periods of active disease.     Patients may have periods of active disease when they may feel sick with fever, fatigue, and     aching or swollen joints. Their blood tests are abnormal and their kidney, lungs or heart may     be affected. At other times, the disease is inactive, and patients feel well, their blood is     normal, and there is no evidence of organ disease.      In lupus, like other autoimmune diseases, the body's immune system attacks it own healthy     tissues. Activated lymphocytes (a type of immune cell) lead to the production of antibodies     and chemical signals that contribute to the disease process. In animals with lupus, these     cells are activated in the lymphoid organs, such as the lymph nodes or spleen. It is not     known exactly where these cells are activated in humans. Because some lymph nodes are located     deep inside the chest and abdomen; surgery is currently the only way to examining them. PET     imaging may provide an alternative, non-invasive, means of obtaining information on lymph     node activity in humans. This test uses a radioactive sugar molecule called F18-FDG to find     areas of increased cellular activity in the body. (Cells use sugar for fuel, so active cells,     such as active lymphocytes, uses more FDG than other body tissues.) This study will determine     whether PET can detect these areas of increased activity in lupus during active disease.      Patients with active or inactive lupus may be eligible for this study. Candidates are     screened with a history, physical examination, and routine blood and urine tests. Women who     are pregnant or breastfeeding may not participate.      Participants will undergo PET scanning. On the day of the scan they have a brief medical     history and physical examination and a blood sample is drawn to check blood count and look     for markers of lymphocyte activation. Then, a small plastic tube (catheter) is placed into a     vein in the patient's arm, the FDG is injected through the catheter, and the patient rests     for an hour. For the scan, the patient lies flat in a cradle that is moved into the central     hole of the doughnut-shaped PET camera, and pictures are taken over the next 2 hours, with     the patient lies quietly, without moving the head or arms. After the scan is finished, the     patient empties the bladder approximately every hour for 6 hours to excrete the radioactive     sugar.   "
167617|NCT00029939|"     This study will use electroencephalography (EEG) to examine how the brain prepares for     movement. It will look at 1) what changes occur in a person's brain just before voluntary     movement, 2) when the changes occur, 3) how consistent the changes are, and 4) how the     changes vary from person to person. The information from this study will be applied to other     studies, such as exploring how brain changes that signal movement can be used to control     prostheses in patients with spinal cord injuries or stroke.      Healthy normal volunteers 18 years of age and older may be eligible for this study. People     with neurologic or psychiatric disorders and people taking medicines that may affect brain     signals (e.g., Valium) may not participate.      Participants will come to the NIH Clinical Center on two separate days for testing sessions     of 2 to 3 hours each. At each session, an EEG cap will be placed on the head to record brain     signals, and electrodes will be placed on the arms to record movement. Subjects will perform     simple movements during the EEG recording, such as flexing their arm of clenching their fist.     Researchers will use the first recording to determine the pattern of how the brain prepares     for movement. During the second recording, they will try to predict the subjects' movements,     based on the patterns discerned in the first recording.   "
167618|NCT00029952|"     Although most patients with hypercortisolism can be diagnosed and treated the long-term     effects of hypercortisolism and its treatment are unknown. This study will attempt to answer     the following questions:        1. What is the rate of perioperative complications? Patients with Cushing syndrome often          undergo transsphenoidal surgery of the pituitary gland as treatment for the disease.          During this surgical procedure the pituitary gland is reached by passing through the          sphenoid bone. The risk for patients to develop hypopituitarism in the immediate          postoperative period is unknown. Patients with Cushing syndrome have abnormal levels of          hormones circulating in the blood and affects of the surgery are often not apparent          until long after the procedure.        2. What is the recurrence rate? The recurrence rate of the disease has been estimated          between 5 - 10%. However, these figures have not been confirmed. If the actual rate of          recurrence is higher than estimated many patients may elect to undergo radiation therapy          which has a lower rate of recurrence.        3. Do any factors in the immediate postoperative period predict who will experience a          recurrence of Cushing syndrome?        4. What are the long-term complications of hypercortisolism? Studies have shown that          patients with hypercortisolism have a four times greater risk of death than people of          the same age without hypercortisolism. Researchers tend to believe this figure is too          high. However, it is well established that hypercortisolism weakens bones (decreased          bone density), causes secondary hypogonadism, increases levels of fat in the blood          (hyperlipidemia), and decreases thyroid function (hypothyroidism). The potential for          these conditions to be reversed is not known.      These questions will be addressed by blood and urine sampling in the postoperative period,     and by outpatient follow-up and periodic questionnaires in the first 10 years after curative     surgery for Cushing syndrome performed at the NIH.   "
167619|NCT00029965|"     This study will evaluate children with glycosphingolipid (GSL) storage disorders to     investigate brain changes that cause nervous system degeneration. No experimental treatments     are offered in this study; participants will receive standard medical care for their disease.     The information from this study may help researchers develop new therapies for these     disorders and monitor the effects of treatment.      Patients of any age with Tay-Sachs disease, Sandhoff disease, GM1 gangliosidosis, or type 2     Gaucher disease may be eligible for this study.      Participants will be admitted to the NIH Clinical Center for 4 to 5 days every 6 months for a     clinical evaluation involving the following tests and procedures:        -  Medical history        -  Physical, neurologic, and eye examinations        -  Developmental evaluations by a physical therapist, nutritionist and psychologist        -  Blood tests to check nutritional status, liver and kidney function, and, in patients          treated for seizures, level of anti-seizure drugs. Some blood will also be used for          research purposes.        -  Urinalysis to check urine sugar levels and kidney function        -  Skin biopsy to obtain cells to grow in culture. The biopsy area is numbed with an          anesthetic cream and a 1/8-inch piece of skin is removed with a circular punch and          scissors.        -  Genetic analysis of DNA to screen for mutations responsible for the patient s GSL          storage disorder        -  Magnetic resonance imaging (MRI) brain scans. Children with type 2 Gaucher disease,          Sandhoff disease and GM1 gangliosidosis will also have liver and spleen scans. Brain          scans will be done every 6 months the first year. After that, they may be done less          often, depending on the results. For the MRI, the child lies still in a narrow cylinder          (the scanner). A magnetic field and radio waves are used to produce pictures of the          organs under study. (Children will be sedated for MRI. Children who cannot be sedated          will not have this test.)        -  Electroencephalogram (EEG) to measure electrical activity of the brain and detect          possible seizures. For this test, electrodes (small metal discs attached to wires) are          attached to the child s head with a paste and the brain waves (electrical activity) are          recorded while the child rests quietly.        -  Brainstem auditory evoked response (BAER) to measure hearing. Electrodes are attached to          the child s head (similar to the EEG procedure) and the brain waves are recorded when a          sound stimulation is given.        -  Lumbar puncture (spinal tap) to study proteins in the cerebrospinal fluid, which bathes          the brain and spinal cord. A needle is inserted in the space between the bones          (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the          needle. This test is done under anesthetic at the same time the MRI is done. If the          child cannot be sedated, a local anesthetic will be used.   "
167620|NCT00029978|"     The purpose of this study is to determine whether visual evoked potentials generated in one     human brain by photostimulation can generate a correlated EEG signal in the brain of another     human subject who is located at a distance and who is not visually stimulated.   "
167631|NCT00030134|"     This protocol will collect information needed to design a clinical study for the symptoms and     problems of women with Fabry disease, an inherited metabolic disorder. In this disease, an     enzyme called a-galactosidase A, which normally breaks down fatty substances called     glycolipids, does not function properly. The resulting accumulation of glycolipids in various     tissues causes arm and leg pain, skin lesions, and problems with the kidneys, heart, nerves,     and blood vessels. This protocol does not involve any experimental drug treatments, but     participants may be offered enrollment in future studies and registries.      Women 18 years of age and older with Fabry disease who have not had enzyme replacement     therapy may participate in this study. Pregnant women are eligible, but may be excluded from     certain procedures, such as magnetic resonance imaging (MRI).      Participants will have the following tests and procedures over a 3-day period:        -  Personal and family medical history        -  Physical, neurological, and eye examinations        -  Blood and urine tests        -  Electrocardiogram (ECG) to measure electrical activity of the heart        -  Echocardiogram (ultrasound) to examine the heart muscles and pumping action        -  Magnetic resonance imaging (MRI) to examine the brain. This test uses a magnetic field          and radio waves to produce images of the brain. The patient lies in a narrow cylinder          (the MRI scanner) during the imaging and may talk with staff at any time during the          procedure.        -  Magnetic resonance angiogram (MRA) to examine the blood vessels in the head and neck.          This procedure is similar to MRI.        -  Genotyping to confirm the diagnosis of Fabry disease. DNA from a blood sample will be          examined for the gene associated with Fabry disease.        -  Skin punch biopsy for microscopic examination of tissue. A piece of skin tissue about          1/8-inch thick is removed with a cookie cutter-like instrument.      Participants will also complete two questionnaires regarding pain and quality of life. They     will be asked to stop taking pain medications for 7 days before completing the pain     questionnaire, but may resume medications before 7 days if the pain is too intense. The     questionnaire will be completed by telephone interview.      Patients will also be asked to keep a diary of pain medications taken for 7 days while on the     study.   "
167632|NCT00030147|"     The purpose of this study is to evaluate the effectiveness of the drugs raloxifene and     rimostil in treating perimenopause-related depression.      Perimenopause-related mood disorders cause significant distress to a large number of women;     the demand for effective therapies to treat these mood disorders is considerable. Estradiol     replacement therapy (ERT) has demonstrated efficacy in treating perimenopause-related     depression. Unfortunately, there are long-term risks associated with ERT. Selective estrogen     receptor modulators (SERMS), such as raloxifene, and phytoestrogens, such as rimostil, have     estrogen-like properties and may offer a safer alternative to ERT. The effect of SERMS and     phytoestrogens on mood and cognitive functioning need to be examined in women with     perimenopause-related depression.      Participants in this study will undergo a medical history, physical examination,     electrocardiogram (EKG), and blood and urine tests. They will then be randomly assigned to     receive one of four treatments for 8 weeks: raloxifene pills plus a placebo (an inactive     substance) skin patch, rimostil pills plus placebo skin patch, estradiol skin patch plus     placebo pills, or placebo patch plus placebo pills. Participants will have clinic visits     every 2 weeks. During the visits, blood will be drawn and participants will meet with staff     members and complete symptom self-rating scales. A urine and blood sample will be collected     at the beginning and end of the study. At the end of the study, participants who received     placebo or whose study medication was ineffective will be offered treatment with standard     antidepressant medications for 8 weeks. Non-menstruating women will receive progesterone for     10 days to induce menstrual bleeding and shedding of the inner layer of the uterus, which may     have been stimulated by the study medications.   "
167633|NCT00030160|"     Recent obesity prevalence increases have made obesity prevention a clear and pressing public     health issue. The average US. woman gains about 0.5 kg per year. Overweight women aged 25 to     44 have a higher prevalence of significant weight gains (BMI increases of > 5 kg/m2) than men     or older or thinner women. The difficulty in successfully losing weight and maintaining     weight loss has resulted in recommendations from several expert panels to advise overweight     and mildly obese individuals free of co-morbidities to avoid weight gains rather than to lose     weight. Physical activity is observed to decline with age while caloric intake remains stable     or declines slightly. There is strong observational evidence that physical activity could     prevent or attenuate age associated fat gains. This randomized, controlled behavioral     intervention trial will test the hypothesis that regular participation in a twice weekly     strength training program over 2 years, can prevent age associated body fat increases (total     and abdominal fat) in 80 overweight to mildly obese premenopausal women between the ages of     25 and 44 years, compared to a 'standard care' group (n=80). The overall aim of the study is     to prevent body fat gains and to reduce health risks associated with obesity. Treatment     effects will be assessed for insulin sensitivity, blood pressure, blood lipids, muscle     strength, and psychosocial predictors of strength training adherence. The innovation of this     approach rests in its simplicity and the minimal time requirement for full participation (2     exercise sessions weekly). A preliminary study of this innovative approach resulted in 88%     exercise session attendance over 12 months and maintenance of treatment effects on total body     fat percentage to the end of pilot study measurements (9 months). This supports the     feasibility and potential for long term efficacy of the proposed intervention approach. The     long-term implication of success in this efficacy trial would be that this modest behavior     change could prevent the fat gains and associated co-morbidities commonly observed in midlife     women.   "
167634|NCT00030173|"     Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic     arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis,     motility, secretion and proliferation, the observed antitumor effects of epothilones have     been attributed to their ability to initiate cell death by inhibiting such processes.     Epothilone D has demonstrated in vitro cytotoxic activity in a panel of human cell lines,     equipotent to that of paclitaxel. In vivo, Epothilone D has also shown significant antitumor     activity in a range of xenograft models, including paclitaxel-resistant xenografts.     Epothilone D is more potent than paclitaxel in cell lines that demonstrate multiple drug     resistant activity overexpressing p-glycoprotein.   "
167635|NCT00030186|"     The purpose of this study is to determine the response rate of patients with refractory,     relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at     a dosage of 60 mg 2 times a day.   "
167832|NCT00030290|"     RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the     tumor without affecting the surrounding tissue.      PURPOSE: Phase I trial to study the effectiveness of focused ultrasound energy in treating     patients who have prostate cancer that has not spread beyond the prostate.   "
167683|NCT00022178|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which combination chemotherapy regimen is more     effective for metastatic cancer of an unknown site of origin.      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination     chemotherapy regimens in treating patients who have metastatic cancer of an unknown site of     origin.   "
167684|NCT00022191|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which combination chemotherapy regimen is more     effective for urinary tract cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus     gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract     cancer.   "
168027|NCT00038948|"     The purpose of this study is to determine the effect of conversion from calcineurin inhibitor     to sirolimus based therapy on renal function.   "
167636|NCT00030199|"     This study will use transcranial magnetic stimulation (TMS) to study how the brain controls     movement of muscles in the face-in particular, those involved in eye blinking. TMS is a     procedure that activates areas of the brain with magnetic pulses that travel through the     scalp and the skull.      Healthy normal volunteers 21 years of age and older may be eligible for this study. They must     be free of any serious medical illness, have no neurological or psychiatric disorders or     history of seizures, and must not be taking any medications that can affect nervous system     function.      Participants will undergo TMS and the electrical activity in muscles activated by the     stimulation will be recorded. For TMS, an insulated wire coil is placed on the patient's     scalp, and a brief electrical current is passed through the coil. This creates a magnetic     pulse that travels through the scalp and skull and causes small electrical currents in the     outer part of the brain. If the coil is placed over a nerve that controls muscles, there may     be a twitch in the muscles, sometimes large enough to move the face. In other cases, there     may be a feeling of movement or tingling sensation in the face. Stimulation over the muscles     on the side of the head may cause some discomfort there or twitching of the jaw. During the     stimulation, subjects may be asked to tense certain muscles slightly or perform other simple     actions.      Electrical activity of the muscles activated by the stimulation is recorded. This is done     with both metal electrodes taped to the skin over the muscle and with fine needle electrodes     inserted into the muscles around the eyes.      The study usually takes less than 3 hours, with frequent breaks. If more time is required,     the study will be broken into more than one session.   "
167637|NCT00030212|"     This study will examine the abnormal immune response in patients with sporadic inclusion body     myositis (s-IBM)-the most common inflammatory muscle disease in people over the age of 50.     s-IBM progresses steadily and may lead to severe weakness and wasting of arm and leg muscles.     Patients may become unable to perform daily living activities and be confined to wheelchairs.     s-IBM is thought to be an autoimmune disease, in which the body's own immune system attacks     healthy muscles. This study will explore the causes of the muscle tissue inflammation that is     responsible for destruction of muscle fibers and weakness in this disease. Information from     the study may help in the development of an effective treatment for this disease.      Patients with s-IBM may be eligible for this study. Those who are unable to travel or who     have severe cardiovascular, renal or other end-stage organ disease will be excluded.     Candidates will be screened for eligibility with a medical history and physical and     neurological examinations.      Participants will be seen at the NIH Clinical Center every six months over a 12-month period     (visits at enrollment, 6 months and 12 months) either on an inpatient or outpatient basis,     depending on their disease severity. Each 2- to 3-day visit will involve the following tests     and evaluations:        -  Blood samples for routine laboratory tests are collected at every visit. Additional          blood for research studies is collected at 12 months.        -  Quantitative muscle strength testing is done at every visit. The patient pulls against          straps connected to dynamometers (devices that measure muscle power) to evaluate          strength of the main muscle groups in the arms and legs.        -  Lymphapheresis is done at enrollment and at 12 months. This is a procedure for          collecting quantities of lymphocytes (white blood cells that are an important part of          the immune system). Blood is collected through a needle placed in an arm vein and          circulated through a machine that spins it, separating it into its components. The          lymphocytes are removed and the rest of the blood (red cells, platelets and plasma) is          returned to the body through the same needle or another needle placed in the other arm.        -  Electrophysiologic studies (electromyography and nerve conduction testing) are done at          enrollment and 12 months. Electromyography evaluates the electrical activity of muscles.          A small needle is inserted into the muscle and the patient is asked to relax or to          contract the muscle. For nerve conduction testing, nerves are stimulated by electrodes          (small wires taped to the skin over the muscle).        -  Muscle biopsy is done at enrollment and 12 months. A sample of muscle tissue (about the          size of a lima bean) from an arm or leg is surgically removed to confirm the diagnosis          of s-IBM and for analysis of proteins involved in the muscle inflammation process. A          local anesthetic is used to numb the area before the surgery and the wound is closed          with stitches.   "
167638|NCT00030225|"     The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver     Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver     transplant or bridge to native liver recovery.   "
167639|NCT00030238|"     This study will examine the health effects of calcium supplements in overweight adults.     Overweight adults often eat a diet low in calcium. Some studies have found low calcium intake     in people who have some of the medical problems often seen in overweight adults. This study     will see if extra calcium improves the health of overweight adults.      Volunteers in general good health 18 years of age or older who are overweight (body mass     index equal to or greater than 25 kilograms per square meter of body surface) may be eligible     for this study. Women who are pregnant or breastfeeding may not participate. The study     includes four visits, described below.      Visit 1      Volunteers will be screened for participation in the study with a medical history, physical     examination, and blood and urine tests. At home, they will collect a 24-hour urine sample;     fill out questionnaires to assess their average calcium intake; and record their food intake     for 7 days. Those enrolled in the study will continue with the next 3 visits.      Visit 2      Participants will complete a physical activity questionnaire, have their food diary reviewed,     and meet with a dietitian for nutritional counseling. Triceps fold thickness and waist and     hip circumferences will be measured three times. Body composition will be analyzed by a DEXA     study. For this procedure, the subject lies on a flat table while a small dose of X-rays is     passed through the body.      Participants will be randomly assigned to take either calcium carbonate (1500 mg/day) or     placebo capsules twice a day by mouth for 2 years. (The placebo looks like the calcium     capsules but contains no calcium.) They will receive a 6-month supply of study capsules     during visit 2 and return to NIH every 6 months for the next supply. They will also be sent     questionnaires by mail every 3 months to complete information about health problems and how     often the study capsules are being taken.      Visits 3 and 4      Visit 3 is scheduled after participants have taken the study capsules for 1 year; visit 4 is     scheduled after 2 years (the end of the study). At each of these visits, participants will     have a DEXA scan, blood and urine tests, blood pressure measurements, and measurements of     height, weight, waist and hip circumference. They will complete questionnaires about their     medical history, side effects of the study medications, dietary calcium intake, and physical     activity, and they will meet with one of the study investigators to talk about any concerns     regarding the study. At the fourth visit, participants will answer some additional questions     about their study participation and return the Diet History Questionnaire that was mailed to     them before the visit.   "
167640|NCT00030264|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining methotrexate with vinblastine may be effective treatment     for neurofibromatosis type 1 associated with progressive plexiform neurofibromas.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have neurofibromatosis type 1 associated with progressive plexiform     neurofibromas.   "
167641|NCT00021554|"     The purpose of this study is to show if a dose of T-20 added to an anti-HIV combination     (chosen specifically for each patient) lowers viral load by at least a certain level after 24     weeks as compared to an anti-HIV combination (chosen specifically for each patient) alone.     Another purpose is to show if the patient response to T-20 will be maintained for 48 weeks.   "
167679|NCT00022126|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Giving the drugs in different combinations may kill more cancer     cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and     kill more cancer cells.      PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or     without donor bone marrow transplantation in treating infants who have previously untreated     acute lymphoblastic leukemia.   "
167682|NCT00022165|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. Selenium may be effective in preventing cancer. It is not yet known     which dose of selenium may be most effective in preventing cancer.      PURPOSE: Randomized pilot study to determine the effectiveness of selenium in preventing     cancer in healthy people.   "
167642|NCT00021567|"     This study will test the safety and effectiveness of inhaled interferon gamma-1b and oral     antibiotics for treating mycobacterium avium complex (MAC) infection of the lungs.      Patients 18 years of age or older with MAC infection of the lungs who 1) have been previously     treated for MAC, or 2) have moderate or severe lung disease due to MAC that has not been     previously treated may be eligible for this study.      Participants will be randomly assigned to one of two treatment groups. Group 1 will receive     500 micrograms of interferon gamma-1b 3 times a week for 48 weeks by inhalation. Group 2 will     inhale a placebo (inactive substance) according to the same regimen. In addition, all     patients will receive standard MAC treatment with three antibiotics-clarithromycin or     azithromycin, ethambutol and rifampin or rifabutin-taken by mouth times a week.      Patients will come to the clinic for a screening visit, baseline visit, 1 month after     beginning treatment, and at 3-month intervals thereafter until the end of the study. During     these various visits, they will undergo the following tests and procedures:        -  Medical history and physical examination, including height and weight measurements,          heart rate, breathing rate, blood pressure and temperature        -  Possibly computed tomography (CT) and X-ray of the lungs        -  Sputum sample        -  Pulmonary function studies        -  Blood and urine tests      Patients' eyes will be examined monthly to check for side effects of ethambutol, and hearing     and balance will be tested to check for side effects of clarithromycin or azithromycin.      At the baseline visit, the patient or caretaker will be trained to use a nebulizer (a special     breathing device) to take the study medication.   "
167643|NCT00021580|"     The experience of the Edmonton Group with islet transplantation and use of the Edmonton     Protocol provides much promise for T1DM patients. However, the need to use 2 or more donor     pancreases to achieve freedom from insulin shots limits the widespread use of this protocol.     Two classes of oral antidiabetic drugs improve insulin action and reduce the amount of     insulin needed to have normal blood sugars. The first part of the proposed project (Group 1)     will use these drugs in conjunction with the Edmonton Protocol to allow for successful islet     transplantation from islets isolated from a single pancreas.      The Edmonton Protocol is a treatment, not a cure. It requires the long-term use of powerful     immunosuppressive drugs that are expensive and increase the risk of infection and cancer.     T1DM patients who have a functioning kidney transplant already have to use immunosuppressive     drugs, and they are still at risk of recurrent diabetic kidney disease and other     complications of diabetes. Islet transplantation in these patients has only rarely been     successful in the past in part because the usual immunosuppressive drugs used in kidney     transplantation cause diabetes and actually harm the transplant kidney in other ways. The     immunosuppressive drugs used in the Edmonton Protocol are less likely to cause diabetes and     are also less harmful to the kidney. In the second part of this project (Group 2), we will     transplant islets into kidney transplant patients after they have switched to the     immunosuppressive medications used in the Edmonton Protocol. Even if some of the patients do     not get islet transplants or still need insulin shots after islet transplantation, we expect     to see improvement in kidney function and blood glucose control.   "
167644|NCT00021632|"     The purpose of this study is to see how treatment of hepatitis C (HCV) patients with     ribavirin (RBV) affects the anti-HIV drugs stavudine (d4T) or zidovudine (ZDV).      Studies have shown that RBV may interfere with the action of ZDV and d4T. There is little     information about the way these drugs interact in the body. This study will examine how the     drug RBV affects levels of ZDV or d4T in patients who are currently on stable anti-HIV     therapy.   "
167645|NCT00021645|"     This study will evaluate whether vitamin E can help treat swelling of the macular area of the     retina (the back part of the eye) associated with uveitis (inflammatory eye disease). The     macula is responsible for sharp vision; swelling in this area is one cause of vision loss in     uveitis patients. Macular swelling is also associated with eye problems related to diabetes.     In these patients, the swelling is thought to be caused by a substance called vascular     endothelial growth factor, or VEGF. High doses of vitamin E have been used to treat these eye     problems in diabetics. This study is a first step to find out if vitamin E will help reduce     the retinal swelling in uveitis, which may also be caused by VEGF.      Patients 9 years of age and older with macular edema associated with uveitis may be eligible     for this study. Candidates will be screened with the following tests and procedures:        -  Medical history and physical examination. This includes measurement of vital signs          (blood pressure, pulse, temperature and breathing rate) and examination of the head and          neck, heart, lungs, abdomen, arms and legs.        -  Eye examination. This includes measurement of visual acuity using a vision chart,          measurement of eye pressure and examination of the pupils and eye movements. The pupils          will be dilated with drops to permit examination of the back of the eye.        -  Fluorescein angiography. This test uses a yellow dye (fluorescein) to take photos of the          retina. The fluorescein is injected into an arm vein and travels to the blood vessels in          the eye. The camera flashes a blue light into the eye and takes pictures of the retina.          The pictures show if the dye has leaked from the blood vessels into the retina.        -  Stereoscopic color fundus photography. These are photographs of the back of the eye,          taken after the pupils have been dilated with drops.        -  Optical coherence tomography. This test measures the macular swelling. It is used to          determine if the swelling is getting worse, better or staying the same.        -  Blood tests. About a tablespoon of blood is drawn to measure inflammation and cell          counts and side effects of treatment.        -  Pregnancy test. All women of child-bearing potential are tested for pregnancy.      Participants will be randomly assigned to daily treatment with oral high-dose vitamin E (1600     units) or placebo (a pill with no active ingredient) for 4 months. They will be examined at 2     months and 4 months with the same tests performed for screening and will return for a final     clinic visit 1 month after treatment has ended.   "
167646|NCT00021658|"     Exposure and health study of pesticide and allergen exposures to pregnant women and children.     Intervention study is planned after assessment is completed.   "
167647|NCT00021671|"     The purpose of this study is to see if antibiotic drugs given to treat an infection of the     uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive     mother to her baby.      A link between bacterial disease of the vagina, premature birth, infection of the uterus     during pregnancy, and the passing of HIV from a mother to her baby has been found. Early     treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to     her baby.      [Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed     that the study antibiotics were not effective in preventing mother-to-child HIV     transmission.]   "
167648|NCT00021697|"     The purpose of this study is to compare and evaluate the safety of AVP-923     (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.   "
167680|NCT00022139|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy, such as paclitaxel, carboplatin, and fluorouracil, work in different ways to     stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with     chemotherapy and giving them before surgery may shrink the tumor so that it can be removed     during surgery.      PURPOSE: This phase II trial is studying how well giving radiation therapy together with     combination chemotherapy followed by esophagectomy works in treating patients with locally     advanced cancer of the esophagus or gastroesophageal junction.   "
167649|NCT00021710|"     This study will try to elucidate learning processes associated with motor training in the     weak arm of stroke patients compared with healthy controls. Results from previous clinical     trials indicate that training may enhance motor function in healthy volunteers, and perhaps     also in stroke patients, even more than 1 year after the stroke. Normal, healthy volunteers     and stroke patients 18 years of age and older may be eligible for this study.      Study subjects will have a physical examination and participate in 6 additional clinic     visits-training and testing sessions on study days 1, 2, 3, 4 and 5, and a final testing     session on day 12. During these sessions, they will perform a series of motor tasks,     including writing, picking up objects, turning cards, stacking checkers and moving cans,     which will be timed and videotaped. Each session will be divided into blocks of 10 trials for     each task, separated by 2-minute rest periods.      Before and after training on days 1, 2, 5 and 12, subjects will have transcranial magnetic     stimulation (TMS) to determine brain changes associated with learning a motor task. For this     procedure, the patient is seated in a comfortable chair, and an insulated wire coil is placed     on the scalp or skin. A brief electrical current is passed through the coil, creating a     magnetic pulse that stimulates the brain. These pulses generate very small electrical     currents in the brain cortex, briefly disrupting the function of the brain cells in the     stimulated area. The stimulation may cause muscle twitching or tingling in the scalp, face,     or limb. During the stimulation, the subject may be asked to slightly tense certain muscles     or perform other simple actions.      Electrical nerve stimulation and electromyography will be done to record muscle responses to     stimulation. A nerve is stimulated by placing wires on the skin over the nerve and passing a     brief electrical current between the wires. Electromyography involves taping metal electrodes     to the skin over the muscle.      Before and after each session, subjects' muscle strength will be tested with a pinch gauge.     They will also be asked to make a mark on a line drawn on paper, to rate their test     performance and levels of attentiveness and fatigue.   "
167650|NCT00021723|"     A multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot     efficacy study of intramuscular AN-1792 in patients with mild to moderate Alzheimer's     disease.   "
167651|NCT00021736|"     The purpose of the study is to determine whether the anti-VEGF drug is effective at     stabilizing and/or improving vision in patients with the wet form of AMD   "
167652|NCT00021749|"     This non-randomized study will test the safety and effectiveness of Genasense in patients     with CLL.   "
167653|NCT00021762|"     The purpose of this study is to see whether or not an HIV vaccination will help the body     control the amount of HIV virus in blood (viral load) in patients who are not taking anti-HIV     medicines.      Doctors are not sure why the body fails to control HIV viral load in most people infected     with HIV. The vaccine Remune has been shown to boost part of the body's immune response to     HIV in patients whose viral load has been lowered with anti-HIV drugs. This study will test     the ability of Remune to improve the body's immune response and to lower HIV viral load in     patients who stop taking anti-HIV drugs for short periods of time.   "
167654|NCT00021775|"     The purpose of this study is to set up a system for doing research on HIV prevention in     various parts of the world.      In order to plan large, long-term studies on the prevention of HIV in different areas of the     world, it is necessary to get certain information first. It is important to know about the     rate of HIV infection and how to get people to enroll for any future studies. This study will     be done at 4 study locations.   "
167655|NCT00021788|"     The goal of islet cell transplantation in patients with Type 1 Diabetes Mellitus is to     provide constant normal blood glucose levels. This may eliminate the need for insulin     altogether or provide a significant reduction in the amount of insulin necessary to maintain     constant normal blood glucose levels. This normalization may prevent or slow progression of     diabetic complications. Furthermore, the participant may enjoy a healthier lifestyle and a     better quality of life.      If you meet the initial inclusion criteria for the trial, you must be able to give informed     consent personally. Then you will need to participate in an extensive screening process that     involves many standard tests and collection of laboratory samples to make sure that the     transplant is suitable and safe for you.   "
167656|NCT00021801|"     The goal of islet cell transplantation in Type 1 diabetics is to provide those affected with     constant normal blood glucose levels, thereby reducing or eliminating altogether the need for     injected insulin. This normalization may prevent or slow progression of diabetic     complications, result in a healthier lifestyle, and lead to a better quality of life.      Participants who meet the inclusion criteria will undergo an extensive screening process     which typically includes a series of blood tests, EKG, chest x-rays, and a psychological     evaluation, among others. Those who are eligible for and chose to participate in the trial     will receive an islet cell transplant and bone marrow infusion from the same donor, together     with following immunosuppressive medications: tacrolimus, sirolimus, daclizumab and     infliximab. Because the bone marrow infusion may successfully prevent the transplanted islet     cells from rejecting, some participants may be able to stop taking the immunosuppressive     medications after a year.      The islet cell transplant is done under local anesthesia in a special procedure radiology     room. Several days after the islet cell transplant, the participant is admitted to the     hospital as an outpatient in order to receive bone marrow via a simple intra-venous infusion     procedure.      All participants will need to be seen at the Diabetes Research Institute after the transplant     for follow-up testing and post-islet cell transplant care.   "
167657|NCT00021814|"     The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by     the National Institutes of Health (NIH). The study will test whether the oral drugs     finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent     further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH).      MTOPS is the largest and longest study to simultaneously test whether these drugs can delay     or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical     centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March     1998. Study doctors will continue to follow these men through November 2001 on a quarterly     basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of     prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality     of life.   "
167658|NCT00021827|"     PTH-related protein, or ''PTHrP'', is a hormone which was discovered in 1987. As its name     implies, it is closely related to another hormone discovered in the 1920's named parathyroid     hormone or ''PTH''. PTH has been shown to be effective in treating osteoporosis in both     animals and humans. PTHrP has been shown to be effective in treating osteoporosis in     laboratory animals, and there are strong scientific reasons to think that it may be effective     in humans as well. However, no human trials with PTHrP in the treatment of osteoporosis have     been performed. The studies in this trial are focussed on determining whether PTHrP can     indeed increase bone mass in postmenopausal women with osteoporosis, when administered daily     by subcutaneous injection for three months.   "
167659|NCT00021840|"     To identify genetic factors that influence the development of asthma in Hispanics.   "
167660|NCT00021853|"     This study will evaluate the effect of motor training on focal hand dystonia in people with     writer's cramp and will examine whether this training affects excitability of the motor     cortex of the brain. In dystonia, muscle spasms cause uncontrolled twisting and repetitive     movement or abnormal postures. Focal dystonia involves just one part of the body, such as the     hand, neck or face. Patients with focal hand dystonia have difficulty with individualized     finger movements, which may be due to increased excitability of the motor cortex.      Patients with hand dystonia 21 years of age or older may be eligible for this 2-month study.     Those taking botulinum toxin injections must stop medication 3 months before entering the     study.      Participants will undergo a complete neurologic examination. They will undergo motor training     with constraint-induced movement therapy. This therapy involves constraining some fingers     while allowing others to move. Participants will have the following tests and procedures at     baseline (before motor training), after 4 weeks of motor training, and again after 8 weeks:        -  Handwriting analysis - A computerized program evaluates the degree of automatic          movements the patient uses in writing, as well as writing pressure and speed.        -  Symptoms evaluation - Patients fill out a written questionnaire about symptoms and rate          their improvement, if any, after training.        -  Transcranial magnetic stimulation - The patient is seated in a comfortable chair, and an          insulated wire coil is placed on the scalp. Brief electrical currents pass through the          coil, creating magnetic pulses that travel to the brain. These pulses generate very          small electrical currents in the brain cortex, briefly disrupting the function of the          brain cells in the stimulated area. The stimulation may cause muscle twitching or          tingling in the scalp, face, arm or hand. During the stimulation, the patient is asked          to slightly tense certain muscles in the hand or arm or perform simple actions.          Electrodes are taped to the skin over the muscles activated by the stimulation, and the          electrical activity in the muscles will be recorded with a computer.        -  Electroencephalogram (EEG) - Wire electrodes are taped to the scalp or placed on a Lycra          cap the patient wears to record the brain's electrical activity.      Participants will have 50-minute motor training sessions 3 times during the first week of the     study, twice the second week and once each in weeks 3 and 4. In addition, they will be     required to practice the training at home for 25 minutes each day during week 1 and 50     minutes each day for the remaining 3 weeks. Fingers not being trained will be splinted.   "
167661|NCT00021866|"     The purpose of this study is to determine if antiepileptic drugs (AEDs) differ in their     neurodevelopmental effects. Specifically, do the children of the women with epilepsy differ     in their behavioral and cognitive development depending on which AED their mother takes     during pregnancy?   "
167662|NCT00021879|"     To investigate the influence of total body fat and visceral fat on risk factors of diabetes     and cardiovascular disease (CVD) in black and white women.   "
167663|NCT00021892|"     To assess the diagnostic and prognostic usefulness of serum markers of left ventricular     remodeling for predicting congestive heart failure.   "
167664|NCT00021905|"     To assess the risk of incident atrial fibrillation after stopping anti-hypertensive     medication including beta-blockers and ACE inhibitors. Also, to assess the role of genetics     in subsequent risk of stroke among patients with atrial fibrillation.   "
167665|NCT00021918|"     To examine the independent association of serum total homocysteine and C-reactive protein     with arteriosclerotic cardiovascular disease morbidity and mortality.   "
167666|NCT00021931|"     To examine the cellular and molecular mechanisms of corticosteroid and leukotriene receptor     antagonists, focusing on their effects on T lymphocytes during both chronic (18 months) and     acute therapy.   "
167667|NCT00021944|"     To test whether novel cardiovascular risk factors are related to the presence and development     of atherosclerosis and macrovascular events in Type 2 diabetes mellitus and to determine     whether intensive glucose lowering therapy will reduce the levels of these cardiovascular     risk factors.   "
167668|NCT00021957|"     To determine the value of serum markers as surrogate endpoints and hemodynamic biomarkers of     congestive heart failure.   "
167669|NCT00021970|"     To determine the effects of four treatments (placebo, a vitamin E and C regimen, a hormone     replacement regimen, and a combined vitamin/hormone replacement regimen) on specific markers     of oxidative damage in coronary arteries of postmenopausal women.   "
167670|NCT00021983|"     RATIONALE: An immunotoxin can locate cancer cells and kill them without harming normal cells.     This may be an effective treatment for hairy cell leukemia.      PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients     who have refractory or recurrent hairy cell leukemia.   "
167671|NCT00021996|"     RATIONALE: Valdecoxib may be effective in relieving chronic pain in cancer patients. It is     not yet known if valdecoxib is effective in treating chronic pain.      PURPOSE: Randomized clinical trial to study the effectiveness of valdecoxib in relieving     chronic pain in cancer patients.   "
167672|NCT00022009|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Treatment plus supportive care may improve quality of life in     patients undergoing cancer treatment.      PURPOSE: Randomized phase II/III trial to compare the effect of different gemcitabine     regimens plus supportive care on quality of life in patients who have locally advanced or     metastatic non-small cell lung cancer.   "
167673|NCT00022022|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which chemotherapy regimen is more effective in     treating non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare two different docetaxel regimens in treating     patients who have stage IIIB or stage IV non-small cell lung cancer.   "
167674|NCT00022035|"     RATIONALE: Flu vaccine may help the body build an immune response and decrease the occurrence     of flu in children who are receiving chemotherapy for acute lymphoblastic leukemia.      PURPOSE: Clinical trial to study the effectiveness of vaccine therapy in preventing flu in     children who have acute lymphoblastic leukemia.   "
167675|NCT00022048|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or deliver cancer-killing substances to them.      PURPOSE: This phase I/II trial is to see if bevacizumab works in treating patients who have     myelodysplastic syndrome.   "
167676|NCT00022074|"     RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if     gabapentin is effective in treating hot flashes.      PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling     hot flashes in women who have breast cancer.   "
167677|NCT00022087|"     RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving     adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective     in preventing bone loss.      PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus     calcium and vitamin D to see how well they work in preventing bone loss in women who are     receiving adjuvant chemotherapy for breast cancer.   "
167678|NCT00022113|"     Phase I trial to study the effectiveness of EMD 121974 in treating patients who have advanced     solid tumors. EMD 121974 may slow the growth of solid tumors by stopping blood flow to the     tumor   "
167685|NCT00022204|"     RATIONALE: Vitamin E and pentoxifylline may be effective in decreasing lymphedema in women     who have received radiation therapy for breast cancer.      PURPOSE: Randomized phase II trial to determine the effectiveness of combining vitamin E and     pentoxifylline in treating women who have lymphedema after receiving radiation therapy for     breast cancer.   "
167686|NCT00022217|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving more than one drug and giving the drugs in different ways     may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of cisplatin-epinephrine injectable gel     plus paclitaxel and carboplatin in treating patients who have recurrent head and neck cancer.   "
167687|NCT00022230|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Biological therapies use different ways to stimulate the immune     system and stop tumor cells from growing. Combining chemotherapy with biological therapy may     kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects of giving chemotherapy together     with biological therapy and to see how well they work in treating patients with stage II or     stage III breast cancer.   "
167688|NCT00022243|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of T138067 in treating patients who have     locally advanced or metastatic non-small cell lung cancer that has not responded to previous     chemotherapy.   "
167689|NCT00022256|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     motexafin gadolinium may make tumor cells more sensitive to radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of motexafin gadolinium plus radiation     therapy to the brain in treating patients who have newly diagnosed glioblastoma multiforme.   "
167690|NCT00022282|"     RATIONALE: AE-941 may help to slow the growth of multiple myeloma.      PURPOSE: Phase II trial to study the effectiveness of neovastat in treating patients who have     relapsed or refractory multiple myeloma.   "
167691|NCT00022295|"     RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary     for cancer cell growth.      PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who     have refractory solid tumors.   "
167692|NCT00022308|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and radiation     therapy in treating patients who have locally advanced non-small cell lung cancer.   "
167693|NCT00022321|"     RATIONALE: Monoclonal antibodies such as gemtuzumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: Randomized phase II trial to study the effectiveness of gemtuzumab in treating     patients who have myelodysplastic syndrome.   "
167694|NCT00022334|"     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make     the body build an immune response to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients     who have liver cancer.   "
167695|NCT00022347|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of TLK286 in treating patients who have     advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.   "
167696|NCT00022360|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of taurolidine in treating patients who     have recurrent or progressive glioma.   "
167697|NCT00022373|"     RATIONALE: Iseganan hydrochloride may be effective in preventing or lessening oral mucositis     in patients who are receiving radiation therapy for head and neck cancer. It is not yet known     if iseganan hydrochloride is effective in preventing oral mucositis.      PURPOSE: Randomized phase III trial to determine the effectiveness of iseganan hydrochloride     in preventing oral mucositis in patients who are receiving radiation therapy for head and     neck cancer.   "
167698|NCT00022386|"     RATIONALE: Epoetin alfa may stimulate red blood cell production to treat patients who have     anemia following chemotherapy.      PURPOSE: Phase IV trial to study the effectiveness of epoetin alfa in treating     chemotherapy-related anemia in women who have stage I, stage II, or stage III breast cancer.   "
167699|NCT00022399|"     RATIONALE: Celecoxib may be an effective treatment for early stage prostate cancer. It is not     yet known if celecoxib is more effective than no treatment before surgery for prostate     cancer.      PURPOSE: Randomized phase I trial to determine the effectiveness of celecoxib given before     surgery to remove the prostate in treating patients who have localized prostate cancer.   "
167700|NCT00022412|"     RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before     surgery.      PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol     before surgery in treating patients who have localized prostate cancer.   "
167701|NCT00022425|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     recurrence of cancer. The use of perillyl alcohol may be effective in preventing the     recurrence of breast cancer.      PURPOSE: Phase I trial to study the effectiveness of perillyl alcohol in preventing the     recurrence of breast cancer in women who have been treated with surgery with or without     adjuvant therapy.   "
167702|NCT00022438|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining     vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.      PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus     interleukin-2 to that of vaccine therapy alone in treating patients who have metastatic     melanoma that has not responded to previous treatment.   "
167703|NCT00022451|"     RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary     for cancer cell growth.      PURPOSE: Phase I trial to study the effectiveness of tipifarnib in treating young patients     who have refractory leukemia.   "
167706|NCT00022490|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by     blocking the enzymes necessary for cancer cell growth.      PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to     see how well it works in treating patients with chronic phase chronic myelogenous leukemia.   "
167707|NCT00022516|"     This randomized, phase III trial was designed to test the efficacy of a low-dose     chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered     following standard chemotherapy in patients with early breast cancer whose tumors are hormone     receptor negative.   "
167708|NCT00022529|"     Phase I trial to study the effectiveness of BMS-214662 plus trastuzumab in treating patients     who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab     can locate tumor cells and either kill them or deliver tumor-killing substances to them     without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may     kill more tumor cells   "
167709|NCT00022542|"     Phase II trial to study the effectiveness of BMS-247550 in treating patients who have     advanced soft tissue sarcoma. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die.   "
167710|NCT00022555|"     Phase I trial to study the effectiveness of bryostatin 1 plus vincristine in treating     patients who have recurrent or refractory lymphoma. Drugs used in chemotherapy use different     ways to stop cancer cells from dividing so they stop growing or die. Bryostatin 1 may help     vincristine kill more cancer cells by making them more sensitive to the drug   "
167711|NCT00022568|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have metastatic melanoma.   "
167712|NCT00022581|"     Phase II trial to study the effectiveness of thalidomide in treating patients who have     relapsed or refractory low-grade non-Hodgkin's lymphoma. Thalidomide may stop the growth of     non-Hodgkin's lymphoma by stopping blood flow to the tumor   "
167713|NCT00022594|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of liposomal lurtotecan in treating     patients who have metastatic or locally recurrent head and neck cancer.   "
167714|NCT00022607|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or deliver cancer-killing substances to them. Thalidomide may stop the growth     of cancer cells by stopping blood flow to the tumor. It is not yet known whether bevacizumab     works better with or without thalidomide for multiple myeloma.      PURPOSE: This randomized phase II trial is to see if bevacizumab works better with or without     thalidomide in treating patients who have relapsed or refractory multiple myeloma.   "
167715|NCT00022620|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who     have refractory or recurrent endometrial cancer.   "
167716|NCT00022633|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in     treating patients who have advanced or recurrent cancer of the urinary tract.   "
167717|NCT00022646|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving more than one drug and giving the drugs in different ways     may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens     of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or     metastatic non-small cell lung cancer.   "
167718|NCT00022659|"     This phase II trial is to see if bevacizumab works in treating patients who have persistent     or recurrent ovarian epithelial cancer or primary peritoneal cancer. Monoclonal antibodies,     such as bevacizumab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or deliver     cancer-killing substances to them.   "
167719|NCT00022672|"     This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab     (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line     treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2)     overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to     receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading     dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg     iv. The anticipated time on study treatment was until disease progression, and the target     sample size was 100-500 individuals.   "
167720|NCT00022685|"     RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: Phase III trial to determine the effectiveness of epratuzumab in treating patients     who have low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or     rituximab.   "
167721|NCT00022698|"     PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan     in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.   "
167722|NCT00022711|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who     have relapsed or progressive small cell lung cancer.   "
167723|NCT00022724|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of CCI-779 in treating patients who have     malignant glioma.   "
167911|NCT00037401|"     To compare the effects of statin therapy alone with statin plus fibrate therapy on several     emerging risk factors for atherosclerotic cardiovascular disease in a representative subgroup     of the ACCORD cohort that is being followed for cardiovascular endpoints.   "
167724|NCT00022737|"     This phase II trial is studying how well combination chemotherapy with or without donor     peripheral stem cell transplant works in treating children with acute lymphoblastic leukemia.     Giving combination chemotherapy before a donor peripheral stem cell transplant helps stop the     growth of cancer cells. It also helps stop the patient's immune system from rejecting the     donor's stem cells. When the healthy stem cells from a donor are infused into the patient     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,     and platelets.   "
167725|NCT00022750|"     Diabetes mellitus imposes a major burden on the public health of the United States, leading     annually to over 300,000 deaths and over $130 billion in costs. This burden falls     disproportionately upon ethnic minority groups, particularly African Americans, who are at     excess risk for the development of type 2 diabetes and for a variety of its most serious     complications. Suboptimal health care - in terms of access, quality, and adherence -appears     to be an important contributing factor. Prior work suggests two possible approaches aimed at     prevention to enhance risk factor control in outpatients with type 2 diabetes. One approach     uses Nurse Case Managers (NCMs) to coordinate care plans with the provider team following     protocols/clinical guidelines and algorithms designed to guide treatment including initiating     and adjusting drug therapy, enhancing continuity of care, promoting interventions and     self-management which include educational and behavioral strategies incorporating feedback     and self-regulation. Another approach uses Community Health Workers (CHWs) to enhance     culturally sensitive outreach, linkage, and monitoring service; to provide important patient     and family education; and to improve access to and continuity of care. Results indicate that     this intensive team approach, compared to usual care alone, produces substantial improvements     in metabolic control. However, the cost-effectiveness of such interventions is unknown in the     ''real-world''.      This has led to our current study, a randomized controlled trial within a managed care     organization to determine the effects of a NCM/CHW team on metabolic control, on the     occurrence of diabetes-related health events, health care utilization, and on direct health     care costs. The participants will be African American adults with type 2 diabetes who receive     primary care within a managed care organization in inner-city Baltimore.   "
167726|NCT00022763|"     This study will evaluate T-20 in children.   "
167727|NCT00022776|"     Lumbar spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the     spinal cord and/or nerve roots) is a condition that occurs frequently, particularly in the     elderly. This condition can lead to significant pain and limit a person's ability to     function. Moreover, doctors disagree about the best way to treat people with lumbar spinal     stenosis.      In this study we will compare surgical treatment of lumbar spinal stenosis with nonsurgical     treatment using physical therapy. The results of this study should help clarify which     treatment strategies are the most effective for patients with lumbar spinal stenosis.   "
167728|NCT00022789|"     To investigate the prevalence and clinical significance of sleep-disordered breathing (SDB)     in children.   "
167729|NCT00022802|"     This project focuses on the further development and clinical testing of an image-guided     surgical system. The system will help surgeons perform procedures that involve inserting a     screw, guide pin, drill bit, or other straight object into bone-for example, inserting screws     in a broken hip bone. These surgeries are currently done with the help of a mobile x-ray     device called a C-arm, which provides the surgeon with x-ray images during the procedure.      C-arms have some disadvantages, including image distortion, radiation exposure, and the need     for time-consuming adjustments of the C-arm during the surgery. The new method would deal     with these shortcomings with a computer-based system that adds to the existing C-arm system.     It would provide the surgeon with a real-time view of the insertion process, and could     improve the accuracy and speed of certain surgical procedures.      Disadvantages associated with C-arms include image distortion, radiation exposure, and time     consuming reconfiguration of the C-arm during the insertion process. The proposed system     would address these shortcomings with a computer-based system that augments the existing     C-arm system.   "
167730|NCT00022815|"     This study will test the safety of a new treatment method called tissue ultrafiltration. We     will test this method in the treatment of compartment syndrome, a condition that occurs when     pressure within the muscles builds to dangerous levels. In the legs and other parts of the     body, a tough, stiff membrane covers groups of muscles and the nerves and blood vessels that     run next to and through them. The entire unit is called a compartment. The causes of     compartment syndrome include traumatic leg injuries and loss of blood supply. In tissue     ultrafiltration, a doctor places hollow probes, or catheters, directly into the muscle     compartment in the injured area of the lower leg. The probes remove fluid from the     compartment (extra fluid can cause increased pressure).      We will do an initial safety study in a group of patients who have had surgery for a broken     tibia (the inner, larger bone of the lower leg) and are at high risk for developing     compartment syndrome. The goals of this initial study are to show that inserting tissue     ultrafiltration catheters in the muscle compartment is safe and can be done repeatedly     without problems; to show that tissue ultrafiltration can be used to monitor the biochemical     environment inside tissues; and to show that the catheter apparatus provides an accurate     measurement of pressure in the compartment.   "
167771|NCT00023387|"     Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl     rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg.      Secondary objective: To describe any correlation between pharmacokinetic parameters of three     different doses of rifapentine plus a standard dose of isoniazid and the occurrence of     toxicity attributed to anti-tuberculosis treatment.   "
168464|NCT00033306|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who     have metastatic colorectal cancer.   "
167731|NCT00022828|"     The goal of this research project is to develop a new system that uses lasers to provide     3-dimensional (3-D) images of the cervical spine (the seven spinal bones in the neck) in a     moving person. Doctors and researchers could use this system to examine people with spinal     disorders and to learn more about how the spine works. The laser technique would be better     than existing imaging methods because it would provide 3-D views of the cervical spine and     would not expose patients to radiation. These two features would make a laser system a safer     and more effective tool than other imaging systems. This technique should be suitable for a     wide variety of uses because the sensitivity of the measurement can be adjusted depending on     what is being studied. The benefits of this research will include helping doctors and other     health practitioners to detect and diagnose painful spinal disorders more effectively. This     should lead to improved treatment and management of spinal disorders.   "
167912|NCT00037414|"     To evaluate the relationship bone marrow density and coronary artery and aortic     calcification.   "
167732|NCT00022841|"     The purpose of this study is to determine whether the drug pamidronate can safely and     effectively improve bone mineral density in growing children who have bone disease caused by     taking steroid medications. People who take steroid medications called glucocorticoids, like     prednisone or dexamethasone, for long periods almost always have decreased bone density and     are at increased risk of breaking a bone. Research has shown that pamidronate improves bone     density in adults who take glucocorticoids. However, use of pamidronate is not approved in     children because it has not been extensively tested in children. It is possible that children     will have a different response or unique problems with the medication because their bones are     still growing. We will assign all study participants to one of two groups. One group will     receive pamidronate intravenously (through a vein) every 3 months in addition of daily oral     calcium and vitamin D and the other group will receive calcium and vitamin D. The study is     scheduled to run for 36 months, with visits to the study center once every 3 months.   "
167733|NCT00022854|"     Anterior cruciate ligament (ACL) reconstruction is surgery that is done to repair a damaged     ligament in the knee. In this study we will look at whether the femoral nerve block, a     commonly used method for pain relief after ACL reconstruction, affects the way patients feel     after surgery. We will study recovery during the first week after surgery and also 3-12 weeks     after surgery. We will give all patients spinal anesthesia. Some patients will also receive a     continuous femoral nerve block for 2 days, or by a single injection. We predict that patients     who received the nerve block will have significantly improved pain results, compared to     patients who did not receive the nerve block.   "
167734|NCT00022867|"     Increasing bone mass during puberty can ultimately decrease the risk of developing     osteoporosis, which causes bones to weaken and break more easily later in life. The purpose     of this study is to compare calcium absorption and bone growth in boys and girls on diets     including either a nondigestible oligosaccharide (NDO) or simple sugar.   "
167735|NCT00022880|"     The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody, to see what     effects it has on patients with CLL and to determine the highest dose of Iodine-131 Anti-B1     Antibody that can be given without causing severe side effects.   "
167736|NCT00022893|"     The purpose of this study is to enable retreatment with Iodine-131 Anti-B1 Antibody therapy     for patients with non-Hodgkin's lymphoma (NHL) who previously responded (PR, CCR, or CR) for     at least 3 months to Iodine-131 Anti-B1 Antibody therapy.   "
167737|NCT00022906|"     The purpose of this study is to determine the proper dose, effectiveness, and safety of using     Iodine-131 Anti-B1 Antibody for the treatment of patients with previously treated     non-Hodgkin's lymphoma (NHL) who have greater than 25% bone marrow involvement with lymphoma.   "
167738|NCT00022919|"     This study will examine prostate tumor tissue cultures to try to identify genetic     abnormalities that contribute to the cause or progression of the disease.      Patients with prostate cancer enrolled in the National Cancer Institute protocol 97-C-0147     (Collection of Serum and Tissue Samples from Patients with Biopsy-Proved or Suspected     Malignant Disease) may be eligible for this study.      Specimens for tissue culture for this study will be obtained from tumors surgically removed     from patients participating in NCI protocol 97-C-0146.      The findings of this study may lead to better methods of predicting the course of disease in     individual patients.   "
167739|NCT00022932|"     The purpose of this study is to determine the safety and effectiveness of using Iodine-131     Anti-B1 Antibody for the treatment of patients with large B-cell non-Hodgkin's lymphoma (NHL)     who have achieved a response following 6-8 cycles of CHOP therapy.   "
167740|NCT00022945|"     The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody followed by     CHOP and to see what effects it has on patients with previously untreated mantel cell     lymphoma.   "
167741|NCT00022958|"     The primary objective of this study is to make Iodine-131 Anti-B1 Antibody more broadly     available to patients. Secondary endpoints of the study will be to obtain additional     information on the efficacy and safety of Iodine-131 Anti-B1 Antibody.   "
167742|NCT00022971|"     This study will evaluate the safety and effectiveness of a combination of two antibodies,     apolizumab and rituximab (Rituxan ), in treating B-cell lymphomas and chronic lymphocytic     leukemia. Rituximab attaches to a molecule called CD20 on B-cell lymphomas and can cause     significant shrinkage of these tumors in up to half of patients. However, it does not cure     the lymphoma, which usually returns. Also, it is not as effective against leukemia.     Apolizumab attaches to a protein called 1D10 on B-cell cancers and has also been able to     shrink tumors in some patients. There is little experience apolizumab in patients with     leukemia. This study will test whether the two antibodies together are more effective against     these tumors than either one alone.      Patients 18 years and older with B-cell lymphoma or chronic lymphocytic leukemia may be     eligible for this study. Patients' leukemia or lymphoma cells must have both the CD20 and     1D10 antigen receptors and must have had at least one systemic treatment for their disease.     Candidates are screened with a medical history and physical examination, blood and urine     tests, electrocardiogram, x-rays and other imaging studies, and possibly a bone marrow     aspirate (withdrawal of a small marrow sample through a needle inserted into the hip bone)     and lumbar puncture (withdrawal of a small sample of cerebrospinal fluid-fluid that bathes     the brain and spinal cord-through a needle placed between the bones in the lower back).      Participants receive infusions of rituximab and apolizumab once a week for 4 weeks. The first     patients in the study receive lower doses of apolizumab with standard doses of rituximab. If     the apolizumab is well tolerated, subsequent patients are given higher doses. Patients are     also given dexamethasone or another similar steroid, diphenhydramine (Benadryl ), and     acetominophen (Tylenol ) to reduce reactions to the antibodies. After 4 weeks of treatment,     patients are followed frequently to examine the response to treatment and evaluate drug side     effects. Patients whose tumors do not grow during the 4 weeks of therapy may be offered     another course of treatment at a later time. Participants are followed periodically after     treatment ends until their disease worsens or the study ends.   "
167833|NCT00030303|"     RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune     response to kill cancer cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have chronic myelogenous leukemia.   "
167799|NCT00023790|"     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to     light to kill tumor cells. This may be effective treatment for skin cancer and cancer that is     metastatic to the skin.      PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy in treating     patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors     metastatic to the skin.   "
167800|NCT00023816|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of carbendazim in treating patients who     have advanced solid tumors or lymphoma.   "
167913|NCT00037427|"     To determine lung airway responses following chlorine gas exposure.   "
167743|NCT00022984|"     This study will explore how people with an implanted cardioverter defibrillator (ICD) feel     that dependence on this life-saving technology affects their health-related quality of life.     ICD therapy is an important treatment option for patients with serious recurrent abnormal     heart rhythms. Overall survival is significantly improved in high risk patients who receive     this therapy. This study will explore patients' perceptions of the impact of this device on     their health status and well being, and their physical, psychological and social functioning.      Patients 18 years of age or older who have an implanted cardioverter defibrillator may be     eligible for this study.      Participants will fill out a questionnaire booklet containing 170 questions about how they     feel about their health, including their concerns and stresses, feelings about dependency on     life-saving technology, and illness perception. There are also questions on demography, such     as age, marital status, employment, etc. The booklet may take up to 30 minutes to complete.      Information obtained from this study may lead to a better understanding of how people feel     about their health after receiving an ICD and help patients and families adapt to living with     the device.   "
167744|NCT00022997|"     This study will explore the genetics of taste and taste deficits. The sense of taste plays a     crucial role in food choices, allowing people to identify beneficial foods (those with high     caloric value, which are typically sweet) and foods likely to be toxic (usually bitter     substances). The loss of sense of taste in older people plays a role in decreased appetite     and poor nutrition. Taste deficits may adversely affect people in ways that are not well     understood. This study will examine why some people (about one-fourth of all people in the     United States) cannot taste a substance called phenylthiocarbamide (PTC). The inability to     taste PTC is due to inherited factors that are not yet clear.      Individuals age 18 and older who can taste PTC and individuals who cannot taste PTC may be     eligible for this study. Participants will taste a number of liquid solutions until they find     one with a clear taste. Then they will taste another group of solutions and decide which ones     have that taste and which have no taste. Finally, they will taste a third group of solutions     until they find one with a different taste. About 2 tablespoons of blood will be drawn from     participants for genetic tests related to the sense of taste.   "
167745|NCT00023010|"     This study will provide long-term monitoring of two patients who received gene therapy for     leukocyte adherence deficiency (LAD) under the Food and Drug Administration investigational     new drug study BB-IND-7949. The IND protocol has been closed. No other patients are eligible     for this study.      Patients previously enrolled in BB-IND-7949 (Retrovirus-Mediated Transfer of the cDNA for     Human CD18 into Peripheral Blood Repopulating cells of Patients with Leukocyte Adherence     Deficiency) will be followed at least yearly for an indefinite period of time to evaluate     their medical status and look for treatment side effects. The follow-up visits at the NIH     Clinical Center will involve the following:        -  Interview regarding health status during the past year        -  Blood draw of approximately 15 milliliters for 3 years, then 5 ml annually thereafter          for studies related to LAD and to make sure no unexpected effects of gene therapy have          occurred      The blood samples collected at the follow-up visits will be frozen and stored. If a serious     medical problem arises, the sample may be checked for replication competent virus. If the     gene therapy is suspected to be related to a medical problem, investigation may include a     review of the patient's medical records or collection of additional blood or tissues for     testing. If the patient should die, the family will be asked permission to perform an     autopsy, regardless of the cause of death. Tissues taken at autopsy will be tested for any     long-term effects from the gene therapy.   "
167746|NCT00023023|"     This study will follow blood transfusion recipients for 6 to 9 months following transfusion     to monitor the quality and safety of blood transfusion. Improved viral testing and careful     donor screening in the last several years has dramatically reduced the rates of     transfusion-related HIV and hepatitis. Nevertheless, ongoing surveillance of     transfusion-related infections is essential to maintain a high safety standard and to     determine the transfusion risk of other infectious agents, such as cytomegalovirus,     Epstein-Barr virus, parvovirus B-19, HHV-8 (Kaposi s sarcoma virus) and other possible     hepatitis viruses that might be blood-transmitted. Transfused patients blood will be tested     for various infectious agents. Their blood samples and blood samples from their donors will     be frozen and stored in a repository so that any new infectious agent can be rapidly     evaluated for its danger to the safety of the blood supply.      Adult patients at the National Institutes of Health and children at the Children s National     Medical Center who are scheduled to receive a blood transfusion or to undergo surgery for     which a blood transfusion may be needed are eligible for this study.      All participants will have a 20- to 25-milliliter (about 2 tablespoonfuls) blood sample drawn     before their transfusion and again at 1, 2, 3 and 6 months after the transfusion. Patients     who are transfused on more than one occasion over the course of the study will provide three     additional monthly samples. Patients who develop a transfusion-transmitted infection during     the study will provide up to four more samples to study the infection and its effects.     Participants will complete a brief questionnaire at the end of the study regarding prior     blood transfusions and the development of any illnesses, such as hepatitis, that might have     been caused by the transfusion.   "
167747|NCT00023036|"     This study will try to identify and understand the genetic factors that lead to an inner ear     malformation called enlarged vestibular aqueducts, that can be associated with hearing     loss.      Patients with sensorineural hearing loss with or without inner ear malformations and their     parents and siblings may be eligible for this study. Participants and their immediate family     members, may undergo some or all of the following tests and procedures:        -  Medical and family history, including questions about hearing, balance and other          ear-related issues, and review of medical records.        -  Routine physical examination.        -  Blood draw or buccal swab (brushing inside the cheek to collect cells) - Tissue is          collected for DNA analysis to look for changes in genes that may be related to hearing          loss.        -  Hearing tests - The subject listens for tones emitted through a small earphone.        -  Balance test (VEMP) to see if balance functions of the inner ear are associated with the          hearing loss Electrodes will be placed behind your ear and at the base of your neck.          From a reclining position, you will be asked to raise your head while clicking sounds          are played into your ears. - Ultrasound tests - An inner ear malformation called EVA          (enlargement of the vestibular aqueduct) indicates that a genetic disorder called          Pendred syndrome may be the cause. Because thyroid abnormalities are also associated          with Pendred syndrome, an ultrasound examination of the thyroid gland may be done.        -  Computed tomography (CT) and magnetic resonance imaging (MRI) scans - These tests show          the structure of the inner ear. For CT, the subject lies still for a short time while          X-ray images are obtained. For MRI, the patient lies on a stretcher that is moved into a          cylindrical machine with a strong magnetic field. The magnetic field and radio waves          produce images of the inner ear. The radio waves cause loud thumping noises that can be          muffled by the use of earplugs.   "
178068|NCT00175851|"     This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients     who have participated in a previous seletracetam study   "
167748|NCT00023049|"     This study will try to identify the genetic causes of hereditary hearing loss or balance     disorders.      People with a hearing or balance disorder that affects more than one family member may be     eligible for this study. They and their immediate family members may undergo some or all of     the following procedures:        -  Medical and family history, including questions about hearing, balance and other          ear-related issues, and review of medical records.        -  Routine physical examination.        -  Blood draw or buccal swab (brushing inside the cheek to collect cells) Tissue is          collected for DNA analysis to look for changes in genes that may be related to hearing          loss.        -  Hearing tests The subject listens for tones emitted through a small earphone.        -  Balance tests to see if balance functions of the inner ear are associated with the          hearing loss In one test the subject wears goggles and watches moving lights while cold          or warm air is blown into the ears. A second test involves sitting in a spinning chair          in a quiet, dark room.        -  Photograph A photograph may be taken as a record of eye shape and color, distance          between the eyes, and hair color.        -  Computed tomography (CT) and magnetic resonance imaging (MRI) scans These tests show the          structure of the inner ear. For CT, the subject lies still for a short time while X-ray          images are obtained. For MRI, the patient lies on a stretcher that is moved into a          cylindrical machine with a strong magnetic field. The magnetic field and radio waves          produce images of the inner ear. The radio waves cause loud thumping noises that can be          muffled by the use of earplugs.   "
167749|NCT00023062|"     This study will use transcranial magnetic stimulation (TMS) to explore how the brain controls     movement by sending messages to the spinal cord and muscles and what goes wrong with this     process in disease. Activity in the motor cortex-the outer part of the brain-will be examined     use TMS in patients with Parkinson's disease and in healthy volunteers.      Normal volunteers and patients with Parkinson's disease (stage I to III) 21 years of age and     older may be eligible for this study.      All participants will have transcranial magnetic stimulation. For this procedure, an     insulated wire coil is placed on the subject's scalp and a brief electrical current is passed     through the coil. This creates a magnetic pulse that passes into the brain and generates very     small electrical currents in the cortex, briefly disrupting the function of the brain cells     in the stimulated area. This may cause muscle twitching or tingling in the face, jaw or limb.     During the stimulation, participants will be asked to tense certain muscles slightly or     perform other simple actions. The electrical activity of the muscle will be recorded on a     computer through electrodes taped to the skin over the muscle. In most cases, the study will     last less than 3 hours. Participants will also fill out questionnaires about aspects of     personality and will be tested for their ability to perform certain cognitive (thinking) and     movement tasks. Patients with Parkinson's disease will, in addition, be administered the     Uniform Parkinson's Disease Rating Scale to measure disease severity.      Patients will be requested to stop all Parkinson's disease medications 12 hours before the     study. They may resume medications immediately after the study. Patients who so wish may be     admitted to the hospital the day or evening before the study while they are off medications     and stay there until they feel ready to leave.   "
167750|NCT00023075|"     This study will use a magnetic resonance imaging technique called nuclear magnetic     spectroscopy (H-MRS) to define the pathology and progression of primary lateral sclerosis,     hereditary spastic paraplegia and amyotrophic lateral sclerosis and assess the usefulness of     this technique in evaluating patients' response to therapy. H-MRS will be used to examine     metabolic changes in the parts of the brain and spinal cord (motor cortex and corticospinal     tract) involved in movement.      Normal volunteers and patients with primary lateral sclerosis, hereditary spastic paraplegia     or amyotrophic lateral sclerosis between 21 and 65 years of age may be eligible for this     study. Participants will have up to five H-MRS studies, including baseline and follow-up     tests. For this procedure, the subject lies on a stretcher that is moved into a strong     magnetic field. Earplugs are worn to muffle the loud knocking noise that occurs during     switching of radio frequencies. The subject will be asked to lie still during each scan, for     1 to 8 minutes at a time. Total scanning time varies from 20 minutes to 2 hours, with most     examinations lasting between 45 and 90 minutes. Communication with the medical staff is     possible at all times during the scan.   "
167751|NCT00023088|"     The primary function of the Department of Rehabilitation Medicine (RMD) is to diagnose and     treat patients at the NIH who have problems in locomotion, activities of daily living,     occupational roles, communication, swallowing, or problems with chronic pain. The major goal     of this department s to help patients achieve maximal function so that they can resume their     daily living activities as normal as possible.      In order for the department to accomplish it's goal it requires the involvement of medical     staff and the use of a variety of tests and instruments. Before a new test, evaluation     technique, or piece of physical equipment can be considered for use in the treatment of     patients it must be carefully studied.      Researchers must make sure the test, technique, or instrument is safe, sensitive, accurate,     specific, and reproducible. Therefore all of these tests, techniques, and instruments must     first undergo a trial period. Normal volunteers and patients from the RMD and outside of the     RMD may be selected to participate in the trial period.      This study provides a framework for researchers in the Department of Rehabilitation Medicine     (RMD) to develop new tests, techniques, technology, and equipment.   "
167752|NCT00023101|"     This prospective cohort study of 400 lead exposed and 400 non-lead exposed women and their     husbands assesses endocrine dysfunction and adverse reproductive outcomes. Residing in two     study areas in Shenyang, China, the women are married, 20 and 34 years of age, never smokers,     have obtained permission to have a child, and have attempted to become pregnant over the     course of the study. Lead exposure is defined by lead levels in blood samples collected at     the baseline survey (both women and their husbands), first and second trimesters, and at     delivery (both maternal and cord blood). Endocrine dysfunction is monitored by urinary     hormone metabolites including follicle-stimulating hormone (FSH), luteinizing hormone (LH),     estrone conjugates (E1C), and pregnanediol-3-glucuronide (PdG). Reproductive endpoints     include menstrual disturbance, time to conception, spontaneous abortion, preterm delivery,     and low birth weight.   "
167796|NCT00023751|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining surgery with chemotherapy and radiation therapy may kill more tumor cells and     prevent recurrence of the cancer.      PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy     and radiation therapy in treating patients who have stage I rectal cancer.   "
167797|NCT00023764|"     Phase II trial to study the effectiveness of bortezomib in treating patients who have     low-grade lymphoproliferative disorders. Bortezomib may stop the growth of cancer cells by     blocking the enzymes necessary for cancer cell growth.   "
178069|NCT00175864|"     This is a safety and efficacy study of add on therapy with seletracetam in patients     experiencing refractory epilepsy.   "
167753|NCT00023114|"     The purpose of this project is to do cross species comparisons of the metabolism and toxicity     of a number of toxicants which require metabolism for toxicity. All of the toxicants in     question are encountered by humans in the workplace, through lifestyle choices (cigarette     smoking) and as a result of environmental contamination. The high incidence of pulmonary     diseases in the human population means that it will be difficult if not impossible to     determine whether humans are at risk from exposure to these chemicals without solid     mechanistic data. Recent rodent bioassays suggest that these compounds have oncogenic     potential further supporting the need to test the potential for injury in primates. As part     of this testing, we intend to establish in vitro methods for assessing critical steps in the     metabolism of these agents and their interaction with cellular macromolecules. Once this is     done, similar studies can be conducted in Rhesus or in human lung tissue that is available     because it cannot be used for transplant purposes.   "
167754|NCT00023127|"     Controlled trial of an intervention to reduce indoor exposures to cockroach allergens among     asthmatic children in NYC.   "
167755|NCT00023140|"     Butadiene is a suspect human carcinogen to which most people are exposed daily. Exposures are     difficult to measure by air sampling. This study examines the relationship between air levels     and several biomarkers of exposure. Biomarkers are substances analyzed in human tissues or     waste products. Adducts are materials formed when a chemical reacts with a biological     material. In this study we are looking at biomarkers in the blood: hemoglobin and DNA     adducts, and urinary metabolites. If a strong relationship is found then the amounts of     biomarkers in a person's blood or urine can tell us how much they have been exposed. The     tests are being conducted on petrochemical workers who have a wide range of exposures to     butadiene. An international group of investigators is conducting the study.   "
167756|NCT00023153|"     This study will evaluate the safety and effectiveness of adefovir plus lamivudine for chronic     hepatitis B infection in people with and without HIV infection. Lamuvidine, an FDA-approved     treatment for hepatitis B infection, also works against HIV. In some patients, the hepatitis     B virus (HBV) continues to reproduce despite lamivudine treatment. Adefovir is an     experimental drug that inhibits HBV replication and may work against some strains of the     virus that have become resistant to lamivudine.      Patients 21 years of age or older with active hepatitis B infection despite treatment with     lamivudine for at least 1 year may be eligible for this 48-week study. Patients both with or     without HIV infection may participate. Candidates will be screened with a medical history,     blood and urine tests, liver ultrasound exam, electrocardiogram (EKG) and chest X-ray.      Participants will have a physical examination, review of their medical history, blood tests,     and a 24-hour urine collection. They will be admitted to the hospital for a liver biopsy to     determine if they can receive the study drug. For this procedure, the patient is given a     sedative for relaxation. The skin over the biopsy is numbed with an anesthetic and the biopsy     needle is passed rapidly into and out of the liver to collect a tissue specimen. Patients are     monitored in the hospital overnight for possible complications. After discharge, they return     home and begin taking the study medications.      Patients will be randomized to two treatment groups. One group will take 10 milligrams/day of     adefovir by mouth, and the other will take a placebo-a lookalike pill with no active     ingredient. Both groups will also take 150 mg lamivudine by mouth and L-carnitine pills or     liquid. Patients with HIV infection will continue to take antiretroviral therapy as well.      Patients will be followed in the clinic at study weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36,     40 and 44 for blood and urine tests to determine the safety of the drug and to evaluate the     response to treatment. On week 48, a repeat 24-hour urine test and repeat liver biopsy will     be done. At the end of the 48 weeks, patients may continue to receive adefovir for another 48     weeks and possibly longer. All those who participate in this extension phase will receive     active adefovir, regardless of whether they had previously taken adefovir or placebo.      All patients will have the option to enroll in a separate study to examine the levels of HBV     (and levels of HIV in HIV-infected patients) in the blood immediately after starting     treatment and to determine if these initial levels can predict later outcome. This involves     seven additional visits, for which participants will be compensated. At these visits, blood     will be drawn on study days 0 (before starting drug treatment), 1, 3, 5, 7, 10 and 21 for HIV     and HBV viral loads and specialized immunology tests.   "
167757|NCT00023166|"     Studies of PEG-paclitaxel have been terminated   "
167758|NCT00023192|"     This study will compare the health and well being of children treated with a modified stem     cell transplantation procedure for chronic granulomatous disease (CGD) with that of children     receiving standard of care treatment. CGD is an inherited disorder of neutrophils-a type of     infection-fighting white blood cell-that leaves patients vulnerable to life-threatening     infections. Standard treatment with antibiotics, and sometimes surgery, is not always     successful, and patients with persisting infections have a poor long-term prognosis.      Transplantation of donated stem cells (cells produced by the bone marrow that mature into     white and red blood cells and platelets) can improve immune function in patients with CGD and     possibly cure the disease. However, this procedure carries a significant risk of death,     because it requires complete suppression of the immune system with high-dose chemotherapy. In     addition, lymphocytes-another type of infection-fighting white blood cell-from the donor may     cause what is called graft versus host disease (GvHD), in which the donor cells 'see'     patient's cells as foreign and mount an immune response to reject them. To try to reduce     these risks, patients in this study will be given low-dose chemotherapy that is easier for     the body to tolerate and involves a shorter period of complete immune suppression. Also, the     donor's lymphocytes will be removed from the rest of the stem cells to be transplanted,     reducing the risk of GvHD.      Patients with CGD between 2 and 17 years of age who 1) are currently free of active     infection, and 2) have a history of at least one life-threatening infection or a family     member with CGD and a history of at least one life-threatening infection, and 3) a family     member that is a suitable donor may be eligible for this study. Candidates will have a     medical history, physical examination and blood tests, lung and heart function tests, x-rays     or CT scans of the body, and dental and eye examinations. They will fill out questionnaires     that measure emotional well being, quality of life, and intelligence (ability to learn and     understand).      Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF     will be injected under the skin for several days to move stem cells from the bone marrow to     the bloodstream. Then, the stem cells will be collected by apheresis. In this procedure the     blood is drawn through a needle placed in one arm and pumped into a machine where the     required cells are separated out and removed. Then, the rest of the blood is returned through     a needle in the other arm.      Several days before the transplant procedure, patients will start a 'conditioning regimen' of     chemotherapy with cyclophosphamide, fludarabine and Campath 1H. When the conditioning therapy     is completed, the donor's stem cells will be infused. To help prevent rejection of donor     cells, cyclosporine will be given by mouth or by vein starting 1 month after the transplant     procedure.      The average hospital stay for stem cell transplantation is 21 days. After discharge, patients     will return to the NIH clinic for follow-up clinic visits weekly or twice weekly for 2 to 3     months. These visits will include a symptom check, physical examination and blood tests.     Subsequent clinic visits will be scheduled 1 to 3 times a year for at least 5 years.   "
167759|NCT00023205|"     People with poor literacy may have worse health and less knowledge about how to manage their     disease than patients at high reading levels. Patients with arthritis usually receive     information on how to manage their disease that is written at an 11th grade reading level.     The purpose of this study is to compare the health outcomes of patients with arthritis given     either standard 11th grade level materials or interactive, in-person arthritis education     along with materials written at a lower reading level.   "
167760|NCT00023218|"     The purpose of this study is to look at how 2 different anti-HIV drug treatments affect the     liver.      The use of anti-HIV drugs like the nucleoside reverse transcriptase inhibitors (NRTIs) may be     linked to liver problems like fatty changes, scarring, abnormal liver function tests (LFTs),     and lactic acidemia (an increase in lactic acid in the blood). Increased liver enzymes may     mean liver damage. The way that the liver changes in people with abnormal LFTs and lactic     acidemia is not completely understood.   "
167761|NCT00023231|"     The purpose of this study is to see the effect of using drugs other than calcineurin     inhibitors to improve the rate of kidney transplant failure.      Kidney transplantation can help children with end-stage kidney disease. However, it has been     difficult to find treatment for donor graft rejection that does not have a lot of side     effects. Researchers hope to find treatments (immunosuppressants) with fewer side effects.     One approach is to avoid using calcineurin inhibitors and to try a new drug known as     sirolimus instead. Another is to use steroids less often. This study will test whether using     sirolimus, fewer steroid treatments, MMF, and certain antibodies will improve long-term graft     survival in children receiving kidney transplants from living donors.   "
167762|NCT00023244|"     The purpose of this study is to examine the effects of withdrawing steroids on graft     rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20     years (prior to their 21st birthday).      Graft survival has improved in recent years in children with kidney transplants. One bad side     effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids     might be safely withdrawn in patients that are receiving other maintenance therapies. If     steroids are removed, children might catch up in their growth and also might have fewer side     effects of other kinds. This study evaluates whether steroid therapy can be withdrawn in a     way that does not increase graft rejection.   "
167763|NCT00023283|"     The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM     enhanced with additional education about addiction and recovery (Enhanced Medical Management,     EMM)   "
167798|NCT00023777|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and daunorubicin     in treating older patients who have acute myeloid leukemia that has not been previously     treated.   "
167764|NCT00023296|"     This study will test whether inhaling nitric oxide (NO) gas mixed with room air can improve     pulmonary hypertension (high blood pressure in the lungs) in patients with sickle cell     anemia.      Patients with sickle cell disease 18 years of age or older may be eligible to participate in     one or more parts of this three-stage study, as follows:      Stage 1      Patients undergo the following tests to determine the cause of their pulmonary hypertension:     blood tests; echocardiogram (heart ultrasound); asthma test; oxygen breathing study with     measurement of arterial blood oxygen levels; chest X-ray; lung scans; MRI of the heart;     6-minute walk test; night-time oxygen measurement while sleeping; and exercise studies.      Stage 2      Patients have a detailed MRI evaluation of the heart and are admitted to the NIH Clinical     Center intensive care unit (ICU) for the following test: A plastic tube is placed in a vein     in the patient's arm and another tube is placed in a deeper neck or leg vein. A third tube is     inserted through the vein into the heart and the lung artery to measure blood pressures in     the heart and lungs directly. Following baseline measurements, three medications (inhaled     oxygen, infused prostaglandin, and inhaled NO) are delivered for 2 hours each, separated by a     30-minute washout period. A small blood sample is drawn during the NO administration.      Patients who cannot be treated with nitric oxide or for whom the treatment does not work may     receive monthly exchange transfusions for 3 months. For this procedure, 3 to 5 five units of     the patient's blood is removed and replaced with 3 to 5 units that do not have sickle     hemoglobin. Some patients who do not respond to NO or exchange transfusions may receive an     alternative therapy, such as oxygen, prostacyclin, L-arginine, bosentan or sidenafil.      Stage 3      Patients remain in the ICU with catheters in place for another 24 hours. During this time     they breathe NO. Lung pressures are measured every 4 hours and blood is drawn every 8 hours.     They then stay in the hospital 1 more day for observation. Patients then breathe nitric oxide     continuously for 2 months using a tank of gas that delivers the NO through tubes placed in     the nose. They may do this at home on an outpatient basis or may remain in the hospital for     the 2 months.      Patients have an echocardiogram and blood tests every week and do a 6-minute walk test every     2 weeks.   "
167765|NCT00023309|"     This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus     adefovir alone to treat chronic hepatitis B infection. The Food and Drug Administration has     approved lamivudine for the treatment of hepatitis B. However, the drug is not effective in     all patients, and many of those in whom it initially works develop resistance after 1 to 3     years. Adefovir is an experimental drug that inhibits replication of the hepatitis B virus     (HBV). Adefovir used alone may be adequate to provide sustained suppression of the virus and     improvement in liver disease. However combining two anti-viral agents may be superior to     using one alone, similar to the strategy employed for the treatment of AIDS. This study will     test whether the combination of lamivudine and adefovir is better than adefovir alone for the     treatment of chronic hepatitis B.      Patients 18 years of age and older, who have been infected with HBV for at least 6 months,     may be eligible for this study. Candidates may not have received lamivudine treatment in the     past 6 months or prior treatment with adefovir and must not be taking other anti-viral     treatments for their hepatitis. They will have a blood test to confirm HBV infection.      Participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical     evaluation. One to 2 weeks after the evaluation, patients will be randomized to begin taking     lamivudine and adefovir, or adefovir alone. Therapy will continue for at least 12 months.     Follow-up clinic visits will be scheduled weekly for the first month, then every 4 to 8 weeks     for the rest of the treatment period. Patients will be evaluated at the end of 1 year.     Patients who have not improved with treatment will stop taking the treatment and will be     evaluated in the clinic once every 4 weeks for another 6 months. Patients who show an     improvement in their liver injury may continue taking lamivudine and adefovir or adefovir     alone for 4 more years, as long as they continue to improve with the medication. Progress     will be evaluated. If the test results show no continued improvement or are negative for     hepatitis B antigens, therapy will be stopped.      Patients who continue treatment for 5 years will be readmitted at year 4 for another medical     evaluation to assess the effects of treatment at that time. After the 5 years all patients     will stop therapy at and be followed with regular clinic visits for at least 6 months.   "
167766|NCT00023322|"     This study will evaluate the safety and effectiveness of a long-acting form of alpha     interferon called pegylated interferon in treating hepatitis D virus (HDV) infection. HDV     only infects people who already have hepatitis B infection. HDV is often severe and     progressive. Alpha interferon is the standard treatment for HDV, given by injection once a     day or three times a week for up to 12 months. However, this treatment does not work for     everyone, and those who respond usually relapse when the drug is stopped. The     sustained-release form of the drug, pegylated interferon, is given just once a week.     Pegylated interferon is more effective than standard interferon in hepatitis C patients, with     patients experiencing longer-term improvement. This study will evaluate the effects of     pegylated interferon on hepatitis D and hepatitis B. It will determine whether long-term     therapy with this drug improves inflammation and scarring of the liver, thereby delaying or     reversing cirrhosis, and whether the improvement can be maintained.      Patients with chronic hepatitis D over 6 years old may be eligible for this study.     Participants will have a medical evaluation, including a history and physical examination,     blood tests, routine urinalysis and 24-hour urine collection. Chest X-ray, electrocardiogram,     abdominal ultrasound and liver biopsy will be done if these tests have not been done within     the last year. In addition, depending on their age and individual health status, some     patients may have exercise stress testing, an eye examination, hearing test, and psychiatric     consultation. All patients will fill out a health-related quality of life questionnaire.      Patients will receive pegylated interferon by injection once a week and have blood tests to     measure the effects of treatment on the liver and on HBV and HDV levels. The medical     examination and liver biopsy will be repeated at the end of 12 months. Patients who improved     with treatment may continue therapy long-term. Medical evaluations and liver biopsies will be     repeated at 3 years and at 5 years.   "
167767|NCT00023335|"     Primary Objective: To compare, at the completion of the follow-up phase, the clinical and     bacteriologic relapse rates associated with the two study regimens.      Secondary Objectives:      To compare the clinical and bacteriologic failure rates of the two study regimens at the     completion of the study phase therapy.      To compare the clinical and bacteriologic response rates for the two study regimens among     patients who began study phase therapy with signs and symptoms of tuberculosis or cultures     positive for M. tuberculosis.      To compare the toxicity associated with the two study regimens by comparing discontinuation     rates due to adverse events and occurrence rates of signs and symptoms associated with     adverse events during study phase therapy.      To compare mortality rates of the two study regimens. To compare the rates of completion of     therapy within 22 weeks for the two study regimens.      To compare the rate of development of drug-resistant tuberculosis in the two study regimens     among study patients classified as treatment failures or relapses.      To compare all of the above performance characteristics for the two study regimens in a small     subset of HIV seropositive patients.      To compare attitudes and beliefs about participation in this study between patients who     complete study therapy and those who fail to complete study therapy.   "
167768|NCT00023348|"     Primary Objectives:      1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal     pharmacokinetic parameters for isoniazid and rifabutin.      Secondary Objectives:        1. To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and          rifabutin.        2. To evaluate the correlation between pharmacokinetic parameters of isoniazid and          rifabutin and the occurrence of toxicity attributed to antituberculous therapy.        3. To evaluate the correlation between pharmacokinetic parameters of isoniazid and          rifabutin and the efficacy of TB therapy.        4. To define and correlate phenotypic INH acetylator status with the results of genotypic          acetylator data obtained in the parent trial.   "
167769|NCT00023361|"     Primary objective:      To determine the rate of confirmed treatment failure and relapse with an intermittent     rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related     tuberculosis (TB).   "
167770|NCT00023374|"     This study is a prospective, open-label, nonrandomized trial using a largely-intermittent,     six-month tuberculosis treatment regimen among patients who will not receive isoniazid due to     the presence of initial isoniazid resistance or intolerance. Subjects are enrolled after     resistance or intolerance to isoniazid has been documented, and are treated for a total of     six months (nine months if baseline chest x-ray shows cavitation and 2-month sputum culture     is positive) with twice weekly or thrice weekly rifampin, ethambutol, and pyrazinamide.   "
173339|NCT00110955|"     The purpose of this study is to compare the effect of darbepoetin alfa against placebo for     the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle     chemotherapy.   "
167772|NCT00023400|"     Primary Objective:      To define the impact of nelfinavir (given at 1250mg bid as part of a combination     antiretroviral regimen) on peak levels and area under the curve for rifabutin and the     rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as     part of tuberculosis chemotherapy.      Secondary Objectives:      To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with     twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg     twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin.      To evaluate the correlation between pharmacokinetic parameters of rifabutin and     25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients     with HIV-related tuberculosis.      To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with     HIV-related tuberculosis.      To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic     studies.   "
167773|NCT00023413|"     The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will     enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based     regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg     daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in     this study.      Primary Objective:      To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with     efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without     efavirenz.   "
167774|NCT00023426|"     Randomized, double-blind study of the tolerability of three different doses of rifapentine   "
167775|NCT00023439|"     This is a pilot study to evaluate the performance of several nucleic acid amplification     methodologies in the diagnosis and management of active tuberculosis   "
167776|NCT00023452|"     Open-label, multi-center, Phase III clinical trial to compare the effectiveness and     tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid     (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH)     to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including     children and HIV-infected persons, who require treatment of latent TB infection (LTBI).   "
167777|NCT00023465|"     It has been shown that neutrophils (a specific type of cell) are involved in inflammation in     the lungs of CF patients. Neutrophil levels in CF patients have been measured by     bronchoalveolar lavage (BAL), which samples cells in the fluid lining of the lungs. Other     studies have measured neutrophil levels and inflammation in other parts of the body using PET     scanning. This study aims to show that PET scanning can be used as a non-invasive marker of     inflammation in the lungs of patients with CF, which would be a useful tool in treatment.      The primary goal of this study is to draw a connection between the level of inflammation     shown in the PET scan and the number of neutrophils obtained from the BAL. This study will     also look at how the PET images relate to inflammatory molecules in the lungs and to the     FEV-1 obtained through spirometry.   "
167778|NCT00023491|"     This study will examine whether transplanted stem cells can turn into salivary gland cells in     stem cell recipients. If so, stem cells might be used to restore salivary gland function in     patients with Sjogren's syndrome and other causes of dry mouth. People with severe dry mouth     may develop difficulty swallowing, severe tooth decay, infections of the mouth and pharynx,     and mouth sores.      Female patients 18 years of age and older who are enrolled in the National Heart, Lung and     Blood Institute's protocol 97-H-009 or 97-H-0202 and who have received a stem cell transplant     from a male donor may be eligible for this study. Five patients with graft-versus host     disease (GVHD) and five without GVHD will be included. GVHD is a transplantation reaction in     which the donor's cells mount an immune response against the recipient's tissues. Patients     with chronic GVHD have mouth ulcerations and dry mouth similar to that of patients with     Sjogren's syndrome. Five healthy female volunteers will also be enrolled.      Participants will have a medical and dental history. Then, cells will be collected from the     inside of the cheek (buccal cell scraping) and from the salivary glands (labial gland biopsy)     as described below:      Buccal cell scraping - Cells are collected from the inside of the cheek by wiping for 5     seconds with a plastic brush.      Labial glands biopsy - The lower lip will be numbed and a small incision will be made on the     inside of the lower lip. Six small salivary glands in the lower lip will be removed and the     incision will be closed with four stitches.      Cells collected from these procedures will be examined to see if donated stem cells turned     into salivary gland or cheek cells.      Patients will return to the clinic 5 to 10 days after the biopsy to have the stitches removed     and assess healing.   "
167779|NCT00023504|"     This study will evaluate immune function in people with a known or suspected immune disorder.     It will determine participants immune response to vaccines by measuring blood antibody levels     after vaccination.      Patients enrolled in a NIH protocol involving immune reconstitution (bone marrow     transplantation or gene therapy) for a known or suspected primary immune disorder may be     eligible for this study.      Participants may be asked to have more than one vaccine, based on their age, use of IVIG,     past immunization history and underlying immune problem. The possible vaccinations include:      Rabies vaccine      Diphtheria and tetanus booster      23 valent pneumococcal polysaccharide vaccine      Pneumococcal 7-valent conjugate vaccine      The diphtheria, tetanus, pneumococcus and rabies vaccines are approved by the Food and Drug     Administration (FDA) and used routinely to protect against disease.      Study participants will have a blood sample drawn before vaccination. The number of     additional samples collected will vary according to the vaccines administered; 1 for rabies;     1 for tetanus; and 1 to 2 for the pneumococcal vaccines. Each sample will be up to 5     teaspoonfuls. Participation in the study may last up to a year, depending on the blood     sampling scheduling   "
167780|NCT00023530|"     The purpose of this network is to accelerate research in hematopoietic stem cell     transplantation by comparing novel therapies to existing ones.   "
167781|NCT00023543|"     The purpose of this study is to test the effect of lifestyle intervention on subclinical     cardiovascular disease measures in women taking hormone replacement therapy (HRT).   "
167782|NCT00023556|"     To examine the genetics of human susceptibility to Chagas' disease, a leading cause of heart     disease throughout Latin America.   "
167903|NCT00037297|"     To locate and identify genes contributing to the genetic component of subclinical     cardiovascular disease (CVD) in Type 2 diabetes and to evaluate the impact of lifestyle and     environment on the expression of these genetic components of subclinical CVD.   "
167783|NCT00023569|"     This study will determine whether an electric shock to the forearm can improve hand function     in patients with chronic stroke and, if so, whether the improvement is related to brain     reorganization. Some studies indicate that electromyography-triggered neuromuscular     electrical stimulation (EMG-triggered NMES) on the forearm improves wrist motor function in     patients with chronic stroke. The shock is delivered to the wrist extensor muscle of the     forearm, causing greater hand movement than the patient can make on his or her own. The study     will determine if the electric shock is more effective given after the patient initiates the     hand movement (EMG-triggered NMES) than at times unrelated to patient effort (NMES alone).      Stroke patients with muscle weakness on one side of the body may be eligible for this study.     The stroke must have occurred at least 12 months before the patient enters the study.     Candidates will have a medical history and physical and neurological examinations.      Participants will be divided randomly into two groups: EMG-triggered NMES, and NMES alone.     For EMG-triggered NMES, two electrodes from the NMES machine and two EMG electrodes are     placed on the wrist extensor muscle of the forearm. The patient relaxes the hand, then     contracts the wrist extensor muscle to produce movement. This movement triggers the NMES to     deliver enough electrical stimulation to produce maximum wrist extension. For NMES alone,     only the two NMES electrodes are placed on the forearm. The patient relaxes the hand and     stimulation is applied at an intensity to produce full wrist extension without any patient     effort.      At the first clinic visit, baseline hand function is measured with the following tests:        -  Wrist extension - wrist extension is measured with a digital instrument called an          accelerometer        -  Pinch power - grip strength between thumb and index finger is measured with a digital          pinch analyzer        -  Jebsen-Taylor hand function - function is evaluated through activities such as moving a          can and lifting a pin        -  H reflex - (Note: I could not find a description of this test or its purpose in the          consent or the protocol)      In addition, transcranial magnetic stimulation (TMS) is done to examine brain activity. For     this test, an insulated wire coil is placed on the patient's scalp. A brief electrical     current passes through the coil, creating a magnetic pulse that travels through the scalp and     skull and causes small electrical currents in the outer part of the brain. The stimulation     may cause muscle, hand or arm twitching, or may affect movement or reflexes. During the     stimulation, electrical activity of muscles are recorded with a computer or other recording     device, using electrodes attached to the skin with tape.      Participants will be instructed in how to use the NMES machine at the first visit. They will     be required to practice with the machine at home 30 minutes twice a day every day for 4     weeks, for a total of about 56 sessions. Follow-up evaluations of hand function will be done     one day after the first NMES or EGM-triggered NMES task, then after 2 weeks and after 4 weeks     of performing the exercise. These evaluations include the tests described above for baseline     measurements, plus TMS.   "
167784|NCT00023582|"     The purpose of this study is to provide biomedical and behavioral information that is     necessary for planning and starting HIV prevention trials in Lima, Peru.      The occurrence of HIV is high among men who have sex with men (MSM) in Lima, Peru, and     bacterial sexually transmitted diseases (STDs) and HSV-2 (genital herpes) are very prevalent     in HIV-positive and -negative MSM there. Methods to reduce both HIV and STDs are urgently     needed among MSM in Peru. The information gained from this study is very important for future     HIV prevention and vaccine trials that will take place in Peru.   "
167785|NCT00023595|"     This study will compare medical therapy with coronary bypass surgery and/or surgical     ventricular reconstruction for patients with congestive heart failure and coronary artery     disease (CAD).   "
167786|NCT00023621|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. The use of celecoxib may be an effective way to prevent the     development of basal cell carcinoma.      PURPOSE: Randomized phase II trial to determine the effectiveness of celecoxib in preventing     basal cell carcinoma in patients who have basal cell nevus syndrome.   "
167787|NCT00023634|"     RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill     cancer cells.      PURPOSE: This phase I trial is studying two different vaccines to treat patients who have     gastric, prostate, or ovarian cancer.   "
167788|NCT00023647|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing     the vaccine directly into a lymph node may cause a stronger immune response and kill more     tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy given directly into a     lymph node in treating patients who have stage IV melanoma.   "
167789|NCT00023660|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Giving radiation therapy in different ways and combining it with chemotherapy may kill     more tumor cells. Celecoxib may slow the growth of cervical cancer by stopping blood flow to     the tumor.      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus celecoxib,     fluorouracil, and cisplatin in treating patients who have locally advanced cervical cancer.   "
167790|NCT00023673|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells     from dividing so they stop growing or die. Combining more than one drug and giving them with     specialized radiation therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined     with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung     cancer.   "
167791|NCT00023686|"     RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor     to kill tumor cells. It is not yet known whether surgery is more effective than internal     radiation in treating prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of     internal radiation in treating patients who have stage II prostate cancer.   "
167792|NCT00023699|"     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor     cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer.      PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have     recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.   "
167793|NCT00023712|"     Phase II trial to study the effectiveness of bortezomib in treating patients who have     persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Bortezomib     may stop the growth of cancer cells by blocking the enzymes necessary for their growth.   "
167794|NCT00023725|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     SU5416 may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known     if radiation therapy is more effective with or without SU5416 in treating soft tissue     sarcoma.      PURPOSE: Phase I/II trial to compare the effectiveness of radiation therapy with or without     SU5416 in treating patients who have stage IB or stage IIA soft tissue sarcoma.   "
167795|NCT00023738|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Drugs such as SU5416 may stop the growth of cancer by stopping     blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells.     Giving chemotherapy, SU5416, and radiation therapy before and after surgery may kill more     tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy, SU5416, radiation     therapy, and surgery in treating patients who have soft tissue sarcoma.   "
167904|NCT00037310|"     To explore the associations between cognitive functioning and three major cardiovascular     disease risk factors: high blood pressure; high total plasma homocysteine (tHcy); and ApoE e4     genotype.   "
167801|NCT00023829|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can     stimulate the growth of prostate cancer cells. Drugs such as, flutamide or bicalutamide may     stop the adrenal glands from producing androgens. Giving radiation therapy with hormone     therapy after surgery to remove the tumor may kill any tumor cells remaining after surgery     and be an effective treatment for stage II or stage III prostate cancer. It is not yet known     if radiation therapy combined with hormone therapy is more effective than either radiation     therapy alone or hormone therapy alone in treating stage II or stage III prostate cancer.     (Hormone therapy alone group closed as of 12/9/2002.)      PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant radiation     therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in     treating patients who have stage II or stage III prostate cancer.   "
167802|NCT00023842|"     RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system     and stop tumor cells from growing. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Combining chemotherapy with biological     therapy may kill more tumor cells. It is not yet known if BCG is more effective with or     without mitomycin.      PURPOSE: Randomized phase II trial to compare the effectiveness of BCG plus mitomycin with     that of BCG alone in treating patients who have bladder cancer.   "
167803|NCT00023855|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of combining PS-341 and doxorubicin in     treating patients who have advanced solid tumors.   "
167804|NCT00023868|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood     flow to the tumor and keeping chemotherapy drugs near the tumor. It is not yet known if     chemoembolization is more effective than standard chemotherapy in treating metastatic cancer.      PURPOSE: This phase I trial and randomized phase III trial is studying the effectiveness of     chemoembolization in treating patients who have colorectal cancer metastatic to the liver.   "
167805|NCT00023881|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who     have chronic myelogenous leukemia in chronic or accelerated phase.   "
167806|NCT00023894|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who     have recurrent or persistent endometrial cancer.   "
167807|NCT00023907|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who     have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.   "
167808|NCT00023920|"     This phase II trial is to see if combining bevacizumab with idarubicin and cytarabine works     better in treating patients who have blast phase chronic myelogenous leukemia. Monoclonal     antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or     deliver cancer-killing substances to them. Drugs used in chemotherapy, such as idarubicin and     cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or     die. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment     for blast phase chronic myelogenous leukemia   "
167809|NCT00023933|"     Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in     treating patients who have recurrent or persistent metastatic colorectal cancer. Radiolabeled     monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them     without harming normal cells. Radiolabeled monoclonal antibody therapy may be effective     treatment for colorectal cancer   "
167810|NCT00023946|"     Phase II trial to study the effectiveness of BMS-247550 in treating patients who have liver     or gallbladder cancer. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die.   "
167811|NCT00023959|"     Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in     different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy     with chemotherapy and radiation therapy may be an effective treatment for head and neck     cancer. This phase I trial is to see if combining bevacizumab, fluorouracil, and hydroxyurea     with radiation therapy works in treating patients who have advanced head and neck cancer   "
167812|NCT00023972|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if gemcitabine is more effective with or     without exatecan mesylate in treating pancreatic cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine alone to that     of gemcitabine and exatecan mesylate in treating patients who have locally advanced or     metastatic pancreatic cancer.   "
167813|NCT00023985|"     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body     build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have non-small cell lung cancer.   "
167814|NCT00023998|"     Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they     stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and     kill them without harming normal cells. Combining monoclonal antibody therapy with     chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of     chemotherapy with or without trastuzumab in treating patients who have metastatic     osteosarcoma   "
167815|NCT00024011|"     Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic     malignant melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die   "
167817|NCT00024037|"     RATIONALE: Laser therapy may reduce the severity of symptoms and speed healing of oral     mucositis. It is not yet known if laser therapy is effective in preventing oral mucositis.      PURPOSE: Randomized phase II/III trial to determine the effectiveness of laser therapy in     preventing oral mucositis in patients who are undergoing bone marrow transplantation.   "
167818|NCT00024050|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Peripheral stem cell transplantation may be able to replace     immune cells that were destroyed by chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral     stem cell transplantation in treating patients who have myelodysplastic syndrome.   "
167819|NCT00024063|"     RATIONALE: Drugs such as SU006668 may stop the growth of solid tumors by stopping blood flow     to the tumor.      PURPOSE: Phase I trial to study the effectiveness of SU006668 in treating patients who have     advanced solid tumors.   "
167820|NCT00024076|"     RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells.     CT-guided radiofrequency ablation may be effective treatment for lung cancer.      PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating     patients who have refractory or advanced lung cancer.   "
167821|NCT00024089|"     Phase II trial to study the effectiveness of gefitinib in treating patients who have     recurrent and/or metastatic head and neck cancer. Biological therapies such as gefitinib may     interfere with the growth of tumor cells by blocking an enzyme necessary for cell growth.   "
167822|NCT00024102|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving them in different ways     after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is     more effective in treating older women with breast cancer.      PURPOSE: This randomized phase III trial is studying different combination chemotherapy     regimens to see how well they work in treating older women who have undergone surgery for     breast cancer.   "
167823|NCT00024115|"     RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal     cells.      PURPOSE: Phase I trial to study the effectiveness of the BL22 immunotoxin in treating     patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.   "
167824|NCT00024128|"     RATIONALE: Donor peripheral stem cell transplantation may be able to replace immune cells     that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells     are rejected by the body's normal tissues. Treatment with donor white blood cells may prevent     this from happening.      PURPOSE: Phase II trial to study the effectiveness of donor peripheral stem cell     transplantation followed by infusions of donor white blood cells in treating patients who     have AIDS-related lymphoma.   "
167825|NCT00024141|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in     treating patients who have advanced solid tumors.   "
167826|NCT00024154|"     This phase II trial is studying how well giving trastuzumab together with gefitinib works in     treating patients with HER2-positive breast cancer. The monoclonal antibody trastuzumab can     locate breast cancer cells that have HER2 on their surface and either kill them or deliver     tumor-killing substances to them without harming normal cells. Biological therapies such as     gefitinib may also interfere with the growth of tumor cells and may enhance the effects of     trastuzumab. Combining trastuzumab with gefitinib may be an effective treatment for     metastatic breast cancers with high amounts of HER2   "
167827|NCT00024167|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radioactive substances such as strontium-89 may relieve bone pain     associated with prostate cancer. It is not yet known whether chemotherapy is more effective     with or without strontium-89 in treating bone metastases.      PURPOSE: This randomized phase III trial is studying giving chemotherapy together with     strontium-89 to see how well it works compared to chemotherapy alone in treating patients     with prostate cancer that has spread to the bone.   "
167828|NCT00024180|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have     hematologic cancer.   "
167829|NCT00024193|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give     higher doses of chemotherapy drugs to kill more tumor cells. Chemotherapy, given before and     after surgery, followed by peripheral stem cell transplantation may be an effective treatment     for metastatic neuroblastoma.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, given before and after     surgery, followed by peripheral stem cell transplantation in treating patients who have     metastatic neuroblastoma.   "
167830|NCT00024206|"     Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced     solid tumors. SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor   "
167831|NCT00030277|"     RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the     tumor without affecting the surrounding tissue.      PURPOSE: This phase I trial is studying focused ultrasound energy to see how well it works in     treating patients with locally recurrent prostate cancer.   "
167834|NCT00030342|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells     from dividing so they stop growing or die. Combining biological therapy with chemotherapy may     kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of biological therapy combined with     chemotherapy in treating patients who have metastatic kidney cancer or colorectal cancer.   "
167835|NCT00030355|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of homoharringtonine in treating     patients who have refractory acute promyelocytic leukemia.   "
167914|NCT00037440|"     To extend knowledge of the genetic factors affecting the course of cardiovascular disease     risk factor development over a substantial portion of an individual's lifetime.   "
167915|NCT00037453|"     To analyze the relationship of sex hormones to lipoproteins in young males.   "
167836|NCT00030368|"     Phase I trial to study the effectiveness of combining bortezomib with paclitaxel in treating     patients who have advanced or metastatic solid tumors. Bortezomib may stop the growth of     cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy     work in different ways to stop tumor cells from dividing so they stop growing or die.     Combining bortezomib with paclitaxel may kill more tumor cells.   "
167837|NCT00030381|"     Iododoxorubicin may dissolve protein deposits and be an effective treatment for primary     systemic amyloidosis. Phase I trial to determine the effectiveness of iododoxorubicin in     treating patients who have primary systemic amyloidosis   "
167838|NCT00030394|"     This phase II trial is studying imatinib mesylate to see how well it works in treating     patients with chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer     cells by blocking the enzymes necessary for cancer cell growth   "
167839|NCT00030407|"     RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs     used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining chemotherapy and celecoxib may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of celecoxib and docetaxel in treating     patients who have non-small cell lung cancer.   "
167840|NCT00030420|"     RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs     used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining chemotherapy with celecoxib may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and docetaxel in     treating patients who have advanced non-small cell lung cancer that has been previously     treated with platinum-based chemotherapy.   "
167841|NCT00030433|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have extensive-stage small cell lung cancer.   "
167842|NCT00030446|"     RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor     cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin     may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining erlotinib and carboplatin in     treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.   "
167843|NCT00030459|"     RATIONALE: Palliative therapy may help patients with advanced cancer live more comfortably.     It is not yet known if palliative therapy is more effective with or without chemotherapy in     treating patients who have malignant mesothelioma.      PURPOSE: Randomized phase II trial to compare the effectiveness of palliative therapy with or     without different chemotherapy regimens in treating patients who have malignant mesothelioma.   "
167844|NCT00030472|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness liposomal doxorubicin in treating patients     who have persistent or recurrent cancer of the cervix.   "
167845|NCT00030485|"     RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor     cells and slow the growth of the tumor.      PURPOSE: Phase II trial to determine the effectiveness of erlotinib in treating patients who     have locally advanced and/or metastatic endometrial cancer.   "
167846|NCT00030498|"     Phase I trial to study the effectiveness of erlotinib in treating patients who have     metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies     such as erlotinib may interfere with the growth of tumor cells and slow the growth of the     tumor   "
167847|NCT00030511|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so     that it can be removed during surgery.      PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with     fluorouracil before surgery in treating patients who have primary or recurrent bile duct     cancer.   "
167848|NCT00030524|"     RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells     and slow the growth of colorectal cancer.      PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have     locally advanced or metastatic colorectal cancer that has not responded to chemotherapy.   "
167849|NCT00030537|"     RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor     cells and slow the growth of the tumor.      PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have     locally advanced or metastatic breast cancer.   "
167850|NCT00030550|"     RATIONALE: Thalidomide may be an effective treatment for anemia caused by myelodysplastic     syndrome.      PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating     anemia in patients who have myelodysplastic syndrome.   "
167851|NCT00030563|"     RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells.     Combining radiofrequency ablation with surgery may kill more tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Giving a chemotherapy drug after surgery and radiofrequency ablation may kill any     remaining tumor cells.      PURPOSE: Phase II trial to determine the effectiveness of surgery with or without     radiofrequency ablation followed by irinotecan in treating patients who have colorectal     cancer that is metastatic to the liver.   "
167852|NCT00030576|"     RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor     cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Combining erlotinib with cisplatin may     kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and cisplatin in     treating patients who have recurrent or metastatic head and neck cancer.   "
167916|NCT00037466|"     To examine the relation between diet and plasma total homocysteine levels in an ethnically     and geographically diverse cohort of adolescents.   "
175585|NCT00140660|"     This study is a multicentric randomized trial evaluating the efficacy of the combination     R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma.   "
167853|NCT00030589|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Photodynamic therapy uses light and drugs that make cancer cells     more sensitive to light to kill cancer cells. Photosensitizing drugs, such as methoxsalen,     are absorbed by cancer cells and, when exposed to light, become active and kill the cancer     cells. Combining chemotherapy with photodynamic therapy may be an effective treatment for     cutaneous T-cell lymphoma.      PURPOSE: Randomized phase II trial to study the effectiveness of combining different doses of     bexarotene with photodynamic therapy in treating patients who have stage IB or stage IIA     cutaneous T-cell lymphoma.   "
167854|NCT00030602|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients     who have recurrent prostate cancer.   "
167855|NCT00030615|"     This phase I trial is studying the side effects and best dose of decitabine in treating     patients with advanced solid tumors that have not responded to previous treatment. Drugs used     in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die   "
167856|NCT00030628|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may     be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is     not yet known if radiosurgery is more effective with or without whole-brain radiation therapy     in treating brain metastases.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or     without whole-brain radiation therapy in treating patients who have brain metastases.   "
167857|NCT00036634|"     This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate     (tenofovir DF).   "
167858|NCT00036647|"     The purpose of this study is to determine if OSI-774 will improve overall survival of     patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of     care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor     receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the     U.S. Food and Drug Administration (FDA).   "
167859|NCT00036660|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have     recurrent malignant glioma.   "
167860|NCT00036686|"     RATIONALE: Eating a diet rich in soy foods may slow the progression of some types of cancer.     Isoflavones are compounds found in soy food that may slow the growth of breast cancer cells     and prevent further development of breast cancer.      PURPOSE: Randomized pilot trial to study the effectiveness of isoflavones in preventing     further development of breast cancer in women who are planning to undergo mastectomy or     lumpectomy.   "
167861|NCT00036712|"     RATIONALE: Light-emitting diode (LED) therapy may be able to prevent mucositis of the mouth.      PURPOSE: Randomized phase II trial to determine the effectiveness of LED therapy in     preventing mucositis of the mouth in children who are receiving chemotherapy with or without     radiation therapy before donor bone marrow transplantation.   "
167862|NCT00036738|"     This phase II trial is studying how well fludarabine phosphate and total-body irradiation     followed by donor peripheral blood stem cell transplant work in treating patients with acute     lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous     treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy,     such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral     blood stem cell transplant helps stop the growth of cancer cells. It may also stop the     patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune system and help destroy any remaining cancer cells     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte     infusion) after the transplant may help increase this effect. Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.   "
167863|NCT00036751|"     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have     stage III or stage IV ovarian epithelial or primary peritoneal cancer that has not responded     to previous treatment. Imatinib mesylate may stop the growth of tumor cells by blocking the     enzymes necessary for cancer cell growth   "
167864|NCT00036764|"     Phase II trial to study the effectiveness of BMS-247550 in treating patients who have stage     IV melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing     so they stop growing or die   "
167865|NCT00036777|"     Phase I trial to study the effectiveness of combining UCN-01 with carboplatin in treating     patients who have advanced solid tumors. UCN-01 may stop the growth of tumor cells by     blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     UCN-01 with carboplatin may kill more tumor cells.   "
167866|NCT00036790|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Motexafin gadolinium may increase the effectiveness of doxorubicin     by making tumor cells more sensitive to the drug.      PURPOSE: Phase I trial to study the effectiveness of combining motexafin gadolinium with     doxorubicin in treating patients who have recurrent or metastatic cancer.   "
167867|NCT00036816|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and     decrease the recurrence of melanoma of the eye.      PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in     treating patients who are at high risk for recurrent melanoma of the eye.   "
167868|NCT00036829|"     RATIONALE: A pain assessment and management system for people with cancer may help doctors     accurately assess and plan more effective pain treatment for patients who have cancer.      PURPOSE: Clinical trial to determine the effectiveness of a pain assessment and management     system in improving pain management in patients who have nonhematologic cancer.   "
167869|NCT00036842|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating men who     have germ cell cancer that has not responded to previous treatment.   "
187300|NCT00288977|"     Study hypothesis is that we can reproduce results of islet transplantation in type one     diabetics in patients with a kidney transplant.   "
167870|NCT00036855|"     Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy with or     without peripheral stem cell transplantation in treating patients who have recurrent or     refractory lymphoma. Radiolabeled monoclonal antibodies can locate cancer cells and deliver     radioactive tumor-killing substances to them without harming normal cells. Peripheral stem     cell transplantation may be able to replace immune cells that were destroyed by anticancer     therapy   "
167871|NCT00036868|"     RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, methotrexate, and     fluorouracil use different ways to stop tumor cells from dividing so they stop growing or     die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them     or deliver tumor-killing substances to them without harming normal cells. Combining     chemotherapy with trastuzumab may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining combination chemotherapy with     trastuzumab in treating women who have metastatic breast cancer.   "
167872|NCT00036881|"     RATIONALE: It is not yet known whether zinc sulfate is effective in preventing the loss of     ability to taste food in cancer patients who are undergoing radiation therapy for head and     neck cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of zinc sulfate in     preventing loss of sense of taste in patients who are undergoing radiation therapy for head     and neck cancer.   "
167873|NCT00036894|"     RATIONALE: CC-5013 may stop the growth of gliomas by stopping blood flow to the tumor.      PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have     recurrent glioma.   "
167874|NCT00036920|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of TLK286 in treating patients who have     advanced non-small cell lung cancer.   "
167875|NCT00036933|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Biological therapies such as QS21 use different ways to stimulate the immune system and stop     cancer cells from growing. Combining vaccine therapy with QS21 may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with QS21 in     treating patients who have prostate cancer.   "
167876|NCT00036946|"     RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by     stopping blood flow to the cancer.      PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in patients who have relapsed     or refractory solid tumors or non-Hodgkin's lymphoma.   "
167877|NCT00036959|"     RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase I trial is studying the side effects of ABT-751 in treating young     patients with refractory solid tumors.   "
167878|NCT00036972|"     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.     Immunotoxin therapy may be effective in treating malignant glioma.      PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy before and after     surgery in treating patients who have recurrent malignant glioma.   "
167879|NCT00036985|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to     several degrees above body temperature. Combining chemotherapy with microwave thermotherapy     before surgery may shrink the tumor so that it can be removed during surgery.      PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy     with or without microwave thermotherapy before surgery in treating women who have locally     advanced breast cancer.   "
167880|NCT00036998|"     RATIONALE: Microwave thermotherapy kills tumor cells by heating them to several degrees above     body temperature.      PURPOSE: Randomized phase II trial to compare the effectiveness of microwave thermotherapy     before surgery to that of surgery alone in treating women who have stage I or stage II breast     cancer.   "
167881|NCT00037011|"     RATIONALE: Biological therapies such as beta-glucan use different ways to stimulate the     immune system and stop cancer cells from growing. Monoclonal antibodies can locate tumor     cells and either kill them or deliver tumor-killing substances to them without harming normal     cells. Combining beta-glucan and monoclonal antibody may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining beta-glucan and monoclonal     antibody in treating patients who have metastatic neuroblastoma.   "
167882|NCT00037024|"     RATIONALE: Telephone counseling by a nutritionist and a personal trainer may improve physical     function and quality of life in patients who have early-stage breast cancer or prostate     cancer.      PURPOSE: Randomized clinical trial to compare the effectiveness of a home-based, diet and     exercise-based counseling program with that of a standard home-based counseling program in     promoting health in patients who have early-stage breast cancer or prostate cancer.   "
167883|NCT00037037|"     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill     tumor cells. Colony-stimulating factors such as sargramostim may increase the number of     immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with     sargramostim may kill more tumor cells.      PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or     without sargramostim in treating patients who have metastatic melanoma.   "
167884|NCT00037050|"     This study will treat patients who have a short term central catheter that is thought to be     infected with a specific bacteria (gram positive bacteria)   "
167905|NCT00037323|"     To examine the relationship between psychosocial characteristics, health behaviors, and the     development of coronary heart disease among participants in the Framingham Offspring Study.   "
167906|NCT00037336|"     To test the theory that accelerated inflammation-promoted atherosclerosis occurs in patients     with rheumatoid arthritis (RA).   "
167907|NCT00037349|"     To investigate whether impaired heart-rate recovery after exercise is a powerful and     independent predictor of mortality.   "
167908|NCT00037362|"     To develop a new statistical index that measures sensitivity to non-ignorability (index of     sensitivity to nonignorability, or ISNI) for model-based inferences.   "
168028|NCT00038961|"     This is a multicentre, randomized, double-blind, placebo controlled study. During this study     all the patients will receive background venous thromboembolism (VTE) mechanical prophylaxis     with intermittent pneumatic compression (IPC).   "
187301|NCT00288990|"     Study Title: A Serologic Study to Correlate b-IFN NAb titers to b-IFN Induced Biomarker     Response in Patients with Multiple Sclerosis      Objectives: Subjects currently on any of the three b-IFN preparations (Avonex (Interferon     b-1a 30 mcg IM Q 7 days), Rebif (Interferon b-1a 22 or 44mcg SC TIW), or Betaseron     (Interferon b-1b 250mcg SC QOD)) will be enrolled to one of 3 groups:      Group 1: Approximately 200 subjects will be enrolled who are NAb+ (titer ³ 20NU/ml) Group 2:     Approximately 50 subjects will be enrolled who are BAb- (titer <8U) and NAb- (titer <20     NU/ml) Group 3: Approximately 50 subjects will be enrolled who are BAb+ (titer ³8U) and NAb-     (titer <20 NU/ml)      The primary objective of this study is to compare baseline b-IFN induced MxA mRNA response in     neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-,     titers < 20NU/ml, BAb-, titers <8U, Group 2) patients.      Secondary objectives are:        1. To compare b-IFN induced MxA mRNA response in neutralizing antibody positive (NAb+,          titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers < 20NU/ml, BAb-, titers          <8U, Group 2) patients at the month 6 visit.        2. To compare b-IFN induced biomarker response (viperin, IFIT1) in neutralizing antibody          positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers <          20NU/ml, BAb-, titers <8U, Group 2) patients (data compared at baseline and month 6          visits)        3. To compare b-IFN induced biomarker response (MxA, viperin, IFIT1) in neutralizing          antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. BAb+ (titers ³8U)/NAb- (titers          <20 NU/ml, Group 3) patients at baseline and month 6 visits.        4. To correlate NAb titer levels with b-IFN induced biomarker response (data taken from          baseline and month 6 visits from Group 1).        5. To compare b-IFN induced biomarker response (MxA, viperin, IFIT1) in BAb-/NAb- patients          (Group 2) vs. BAb +/NAb- patients (Group 3) in order to determine if BAbs affect b-IFN          induced biomarker response (data compared at baseline and month 6 visits).      Tertiary objectives are:      1. To explore patient characteristics that may predict NAb positivity.      Design: This is a multi-center, open-label study of approximately 300 (200 NAb+ and 100 NAb-     (50 BAb+ and 50 BAb-)) MS patients that will compare b-IFN induced biomarker response     following b-IFN injection in neutralizing antibody positive vs. antibody negative patients.      Study Population: Approximately 300 subjects (200 in Group 1, 50 in Group 2, and 50 in Group     3) will be recruited for the study.      Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of the     following eligibility criteria at the time of randomization:        1. Patients (male or female) diagnosed with relapsing forms of MS.        2. Currently being treated with the same b-IFN (in accordance with FDA approved dosing and          schedules) for 12 to 48 months inclusive.        3. All levels of disability        4. Age 18-65 years inclusive        5. Subjects must be willing to be followed for the 6-month study period.      Exclusion Criteria: Candidates will be excluded from study entry if any of the following     exclusion criteria exist at the time of study initiation.        1. Patients with prior b-IFN NAb test (whether positive or negative).        2. Patients who are currently being treated or have been treated within 6 months prior to          screening with combination therapy (b-IFN plus any other          immunosuppressant/immunomodulatory) other than IV steroids (either pulse or for a          relapse).        3. Unwillingness or inability to comply with the requirements of this protocol including          the presence of any condition (physical, mental, or social) that is likely to affect the          subject's ability to comply with the study protocol.        4. Any other reasons that, in the opinion of the Investigator, the subject is determined to          be unsuitable for enrollment into this study.      Treatment Groups: This is a multi-center, open-label study of approximately 300 (200 NAb+     patients and 100 NAb- patients (50 BAb+ and 50 BAb-)) relapsing MS patients that will compare     b-IFN induced biomarker response following b-IFN injection in neutralizing antibody positive     vs. antibody negative patients.      Subjects currently on any of the three b-IFN preparations (Avonex (Interferon b-1a 30 mcg IM     Q 7 days), Rebif (Interferon b-1a 22 or 44mcg SC TIW), or Betaseron (Interferon b-1b 250mcg     SC QOD)) will be enrolled to one of 3 groups:      Group 1: Approximately 200 subjects will be enrolled who are NAb+ (titer ³ 20NU/ml)      Group 2: Approximately 50 subjects will be enrolled who are BAb- (titer <8U) and NAb- (titer     <20 NU/ml)      Group 3: Approximately 50 subjects will be enrolled who are BAb+ (titer ³8U) and NAb- (titer     <20 NU/ml)   "
167885|NCT00037063|"     The purpose of this study is to see if certain vitamins (C, E, B1, and B2) can keep lactate     levels from becoming too high in patients who are taking nucleoside reverse transcriptase     inhibitor (NRTI) anti-HIV drugs.      Some patients taking anti-HIV drugs develop hyperlactatemia. Hyperlactatemia is a condition     in which lactate (a natural substance normally present in the body) levels are too high. Too     much lactate in the body can lead to serious health problems. When patients suffer from     hyperlactatemia while taking anti-HIV drugs, most doctors temporarily stop the drugs.     Patients then restart the anti-HIV drugs when their lactate levels return to normal. If     patients restart the same drugs they were taking when they developed hyperlactatemia, there     is a risk that they may develop high lactate levels again. This study wants to find out if     taking antioxidants (substances that reduce tissue damage due to oxygen radicals) and certain     B vitamins may help prevent patients from developing hyperlactatemia when they restart the     same anti-HIV drugs.   "
167886|NCT00037076|"     The purpose of this study is to find out how many children who are infected with HIV are also     infected with hepatitis C virus (HCV).      HCV infection is a major health concern. HIV-infected adults who are co-infected with HCV     appear to have more rapid HIV disease progression. There is little data on how widespread HCV     is among children who are HIV-infected. Information from this study will help determine the     need for future HCV studies. This study also will obtain blood samples for future testing for     other hepatitis viruses such as hepatitis G virus (HGV or GB virus C).   "
167887|NCT00037089|"     This study is for patients with esophageal cancer that has spread to other areas. The purpose     of this study is to:        1. Determine how well a combination of taxol, UFT, and leucovorin work in these patients,        2. Determine the survival of patients with metastatic esophageal carcinoma treated with          this combination of drugs.        3. Identify the side effects of this drug combination.   "
167888|NCT00037102|"     The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta     1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue.   "
167889|NCT00037115|"     The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta     1-a) and a one-time high dose intravenous methotrexate with Leucovorin rescue, along with the     standard solumedrol treatment before beginning AVONEX® treatment.   "
167890|NCT00037128|"     Lupus flares and other symptoms associated with systemic lupus erythematosus (SLE) may be     caused by a deficiency of dehydroepiandrosterone (DHEA). GL701 is an investigational new drug     meant to enhance DHEA levels. This study is designed to evaluate both the safety and efficacy     of GL701 in male lupus patients.   "
167891|NCT00037141|"     Multi-center, prospective randomized dosing and safety research study. A maximum of 150 men     will be enrolled in the study. Qualifying patients will receive one of three possible doses     of the study drug. Symptoms will be evaluated before treatment, and then 1-week, 1-month,     3-months, and 6-months following treatment.   "
167892|NCT00037154|"     The purpose of this study is to test whether an extract of the saw palmetto plant is     effective for relieving symptoms of Benign Prostatic Hyperplasia (BPH).   "
167893|NCT00037167|"     This study uses a patented type of exercise poles, developed to assist runners rehabilitating     from lower body injuries. These poles may offer older adults improved stability, reduced fear     of falling, and lessened lower body pain when exercise walking.   "
167894|NCT00037180|"     The Diarrhea Prevention with an investigational drug trial, will evaluate whether adding an     investigational drug to the standard treatment for advanced colorectal cancer can reduce the     amount of diarrhea a patient experiences. The standard and approved treatment for patients     with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a     combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as     5FU), and leucovorin (also known as LV). Preclinical data from animal models suggest that the     investigational drug may offer an effective means for preventing CPT-11/5FU/LV-induced     diarrhea. It is also hypothesized that the investigational drug-mediated anti-angiogenesis     could induce a favorable tumor response.   "
167895|NCT00037193|"     Patients with end stage renal disease often have secondary hyperparathyroidism due to high     phosphorus and low calcium levels in the blood. Preliminary animal studies and our initial     human study indicate that the parathyroid hormone levels may change quickly based on the     ingestion of phosphorus, prior to any change in the blood levels of calcium or phosphorus.     This follow-up study will attempt to determine if the effect is independent of an increase in     the blood glucose level. If so, this would suggest an as yet unidentified gastrointestinal     receptor that mediates parathyroid hormone levels. This may affect the timing of     administration and the type of phosphate binder used in treating patients with secondary     hyperparathyroidism. The knowledge that parathyroid hormone levels can change acutely may     also affect the recommended timing of blood samples   "
167896|NCT00037206|"     The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients     treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety     and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated     patients located in the United States, Europe, and South Africa.   "
167897|NCT00037219|"     Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose     of the study is to find the balance between dose tolerance and effectiveness of several doses     for the treatment of United States patients with invasive candidiasis.   "
167898|NCT00037232|"     To develop statistical methodologies to study genetic and environmental factors in     cardiovascular disease, using age at onset data from population-based family studies of     disease incidence.   "
167899|NCT00037245|"     To examine whether serum androgens, measured earlier in life, and variation in genes related     to androgen synthesis, metabolism, and signaling are associated with early-onset subclinical     coronary atherosclerosis in young adult women from the community.   "
167900|NCT00037258|"     To determine the role of dyslipidemia, markers of endothelial dysfunction genetic     susceptibility, and dietary fat intake on the development of cardiovascular disease (CVD)     complications in Type II diabetes mellitus.   "
167901|NCT00037271|"     To scan the genome for obesity in a multi-ethnic sample.   "
167902|NCT00037284|"     To explore the immune/inflammatory processes as pathways between depression/exhaustion and     coronary artery disease (CAD) progression.   "
167917|NCT00037479|"     The purpose of this study is to determine whether patients with persistent memory problems     after Lyme disease benefit from an additional longer course of IV antibiotic therapy; to use     modern brain imaging technology to determine whether the problem in the central nervous     system is primarily one of poor blood flow or one of impaired nerve cell functioning; and to     try to identify biological markers prior to treatment that will identify patients who are     more or less likely to respond to the study treatment.   "
167918|NCT00037492|"     The purpose of this trial is to assess the effects of a psychosocial intervention on     functional recovery after stroke.   "
167919|NCT00037505|"     The overall purpose of this research is to examine whether depression influences immune     system function. Studies indicate that individuals who are depressed experience coronary     heart disease at a higher rate than expected. This study's goal is to begin identifying     mechanisms that might be responsible for this process. This research also examines whether     behavioral processes (e.g. smoking) or hormonal processes (e.g. adrenaline release) are     responsible for immune system differences between depressed and nondepressed people   "
167920|NCT00037518|"     This study will assess an investigational medication for patients with severe primary     hyperparathyroidism or parathyroid cancer.   "
167921|NCT00037531|"     To evaluate the safety of long-term administration of sirolimus oral solution for up to 5     additional years, or until the tablet formulation is commercially available (whichever occurs     first) in solid organ transplant recipients who are currently receiving sirolimus and who     have completed clinical trials with sirolimus (with or without cyclosporine (CsA). To     evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets     administered for up to 5 years, or until the tablet formulation is commercially available in     solid organ transplant recipients who are currently receiving sirolimus and who have     completed clinical trials with sirolimus (with or without CsA) or who are currently enrolled     in protocol 0468E1-306-US.   "
167922|NCT00037544|"     To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes     during prophylaxis treatment, including neoantigenicity.   "
167923|NCT00037557|"     To characterize the safety and efficacy of rFIX in children less than 6 years of age with     severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery.      This study will provide an opportunity for systematic observation of treatment with rFIX in     children less than 6 years of age regardless of prior FIX treatment. Younger patients exhibit     a different pharmacokinetic profile and therefore may respond differently to rFIX infusions     when compared with older children and adults. This evaluation will provide data from which     recommendations can be made regarding rFIX dosing and treatment of these patients.     Surveillance for certain observations that have been made in patients treated with rFIX in     the clinical and postmarketing setting will be performed, including inhibitor development,     thrombogenicity, FIX recovery/lack of effect, allergic-type manifestations, and RBC     agglutination. Comparisons will be derived from published reports and communications     describing experience with other FIX products and protein therapeutics in general.   "
167924|NCT00037570|"     This is a multicenter, randomized, double-blind, parallel-group, dose-ranging,     comparator-controlled study of the effect of pantoprazole on intragastric pH after successful     endoscopic hemostasis in hospitalized patients. Patients will receive either intravenous     pantoprazole (one of two regimens) or ranitidine (the comparator) within 2 hours of     successful hemostasis and administration will continue for 72 hours after hemostasis.   "
167925|NCT00037583|"     The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab     ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of     gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.   "
167926|NCT00037596|"     The primary objectives are a) to establish the maximum tolerated dose of gemtuzumab     ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab     ozogamicin when given concurrently with cytarabine.   "
167927|NCT00037609|"     The primary objective of the phase I study is to determine a safe dose for combination     therapy with capecitabine and exisulind. A secondary objective is to assess pharmacokinetic     interactions between the two drugs and assess the biological activity of exisulind.      The primary objective of the Phase II part of this study is to assess the anti-tumor activity     of this combination therapy measured by objective tumor response. Secondary end points also     assessed will be toxicity of therapy, duration of response and time to progression.   "
167928|NCT00037622|"     The purpose of this study is to determine the safety and antiviral HBV activity of     ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase     1 and 2 Studies in Chronic Hepatitis B Infection.   "
167929|NCT00037635|"     This 6 month long study will assess an investigational medication for patients on dialysis     with secondary hyperparathyroidism. The study will look at the effects on parathyroid     hormone, calcium and phosphorus levels.   "
167930|NCT00037648|"     The purpose of this study is to determine the safety of anakinra in patients with     Polyarticular-Course Juvenile Rheumatoid Arthritis, a form of rheumatoid arthritis affecting     children.   "
167931|NCT00037661|"     Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry     eye.   "
167932|NCT00037674|"     This primary purpose of this study is to evaluate the safety and efficacy of topiramate     compared with lithium or placebo in the treatment of acute manic or mixed episodes in     patients with Bipolar I Disorder.   "
167934|NCT00037700|"     The purpose of this study is to evaluate the effect of anakinra (IL-1 ra) and pegsunercept     (PEG sTNF-RI) when they are used together in improving the signs and symptoms of rheumatoid     arthritis. The study will also evaluate the safety of the combination treatment and its     effect on slowing down bone and joint destruction due to rheumatoid arthritis. The results     will be compared to the effect when only 1 single medication (anakinra or pegsunercept) is     used.   "
167970|NCT00038181|"     The goal of this clinical research study is to find out whether it is safe to treat patients     diagnosed with locally advanced prostate cancer with the drug Thalidomide before removing the     tumor (radical retropubic prostatectomy).      Researchers also want to learn if Thalidomide can shrink or slow the growth of the prostate     cancer before the surgery   "
188585|NCT00319917|"     The purpose of the study is to assess the efficacy on joint damage and safety in RA patients     treated with DMARDs in a double blind, placebo controlled study.   "
167935|NCT00037713|"     This trial is designed to test the impact of adjuvant BEC2 (2.5 mg)/BCG vaccination on     survival in patients with LD Small Cell Lung Cancer (SCLC). Patients will be stratified by     institution, KPS (60 - 70% vs 80 - 100%), and response to first line combined modality     therapy (CR vs PR) that consisted of at least a 2 drug regimen (4 - 6 cycles) and a chest     radiotherapy regimen. Patients will be randomized to one of two treatment arms: standard arm     (Observational cohort) or best supportive care, or the treatment arm (5 intradermal     vaccinations of BEC2 (2.5 mg) + BCG given on day 1 of weeks 0, 2, 4, 6, and 10.   "
167936|NCT00037726|"     To examine possible relationships between antibiotic use, as determined by prescriptions     filled, and asthma in children ages 6 to 7.   "
167937|NCT00037739|"     To localize within the genome a chronic obstructive pulmonary disease susceptibility gene.   "
167938|NCT00037752|"     The purpose of this study is to determine if sibutramine will decrease post-cessation weight     gain and cigarette smoking in overweight and obese smokers who quit smoking.   "
167939|NCT00037765|"     The purpose of this study is to examine genetic modifiers of the severity of cystic fibrosis     lung disease.   "
167940|NCT00037778|"     The purpose of this study is to identify modifier genes in cystic fibrosis (CF).   "
167941|NCT00037791|"     Intensive chemotherapy is associated with significant thrombocytopenia, often requiring     platelet transfusion to maintain platelet counts. This investigational drug has demonstrated     the ability to increase platelet counts. This study will test the safety and efficacy of this     investigational drug in the prevention of thrombocytopenia in patients with solid tumors,     lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring     platelet transfusion support.   "
167942|NCT00037804|"     Drugs used in chemotherapy us different ways to stop tumor cells from dividing so they stop     growing or die. Irinotecan may be effective in treating patients with refractory solid tumors     and liver dysfunction.   "
167943|NCT00037817|"     Background:      Previously we have demonstrated induction of tumor antigen and tumor suppressor gene     expression in lung cancer cells following exposure to the DNA demethylating agent, Decitabine     (DAC). We have also demonstrated that DAC mediated target gene expression and apoptosis can     be significantly enhanced in cancer cells by subsequent exposure to the histone deacetylase     (HDAC) inhibitor Depsipeptide FK228 (DP). Furthermore, we have demonstrated that following     DAC, or DAC/DP exposure, cancer cells can be recognized by cytolytic T cells specific for the     cancer testis antigen, NY-FSO-1.      This Phase I study will evaluate gene induction in thoracic oncology patients mediated by     sequential DAC/DP treatment with or without the selective COX-2 inhibitor, celecoxib.      Objectives:      Evaluation of the pharmacokinetics and toxicity of continuous 72-hour intravenous Decitabine     (DAC) infusion followed by 4-hour intravenous infusion of Depsipeptide FK228 (DP) with or     without oral celecoxib in patients with unresectable cancers involving the lungs or pleura.      Analysis of NY-ESO-1, p16 and p21 expression in cancer specimens before and after sequential     Decitabine/Depsipeptide treatment.      Analysis of serologic response to NY-ESO-1 before and after sequential drug treatment.      Analysis of apoptosis in tumor biopsies before and after sequential Decitabine/Depsipeptide     treatment.      Refinement of laser capture microdissection and micro-array techniques for analysis of gene     expression profiles in tumor tissues.      Eligibility:      Patients with histologically or cytologically proven primary small cell or non-small cell     lung cancers, advanced esophageal cancers, pleural mesotheliomas, or non-thoracic cancers     with metastases to the lungs or pleura.      Patients must be 18 years or older with an ECOG performance status of 0-2 and have adequate     pulmonary reserve evidenced by FEV1 and DLCO greater than the 30% predicted, and less than 50     mm Hg and p02 greater than 60 mm Hg on room air ABG.      Patients must have a platelet count greater than 100.000. an ANC equal to or greater than     1500 without transfusion or cytokine support, a normal PT, and adequate hepatic function as     evidenced by a total bilirubin of less than 1.5 x upper limits of normal. Serum creatinine     less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70     ml/min/1.73m(2).      Design:      Patients with inoperable malignancies involving lungs or pleura will receive two cycles of     72-hour intravenous infusion of Decitabine followed by 4-hour Depsipeptide infusion using a     Phase I study design.      Decitabine will be administered by continuous infusion on days 1-4, and patient cohorts will     receive escalating doses of Depsipeptide administered on day 4 and day 10 of a 34 day cycle.      Once the MTD and toxicities for sequential DAC/DP have been identified, additional cohorts of     6 lung cancer patients and 6 mesothelioma patients will receive sequential DAC/DP     administered at the MTD as outlined above with celecoxib (400mg bid) administered on days     4-34 of each treatment cycle, as a means to enhance target cell apoptosis and facilitate     anti-tumor immune recognition/response.      Pharmacokinetics, systemic toxicity, and response to therapy will be recorded. Tumor biopsies     will be obtained prior to, and after therapy to evaluate expression of NY-ESO-1 tumor     antigen, as well as p16 and p21 tumor suppressor genes, which are known to be modulated by     chromatin structure. Additional analysis will be undertaken to evaluate the extent of     apoptosis in tumor tissues, and to determine if immune recognition of NY-ESO-1 can be     demonstrated following sequential DAC?DP +/- celecoxib treatment.      As the exact set of comparisons and analyses to be performed will be determined following     completion of the trial and will be based on limited numbers of patients, the analyses will     be considered exploratory and hypothesis generating rather than definitive.      A total of 40 patients will be enrolled.   "
167944|NCT00037830|"     The purpose of this trial is to examine the short term effects (24 Weeks) of GM1 on     Parkinson's disease (PD) symptoms, as well as the effects of long-term treatment (120 Weeks)     with GM1 on disease progression, and to examine the extent to which GM1 treatment influences     the underlying disease process in PD.   "
167945|NCT00037843|"     This is a clinical research study using I-131 Iodocholesterol which is an experimental     radioactive chemical that when injected into the vein, is picked up in the adrenal glands and     permits visualization with gamma imaging devices. These images are used in diagnosing a     variety of adrenal abnormalities.Prior to the injection of I-131 Iodocholesterol, the patient     will receive perchlorate capsules to block any uptake of I-131 by the thyroid gland if this     is deemed important. The patient will continue to take these capsules throughout the period     of imaging, which may last up to 1 week. The injection of I-131 Iodocholesterol will be given     into a vein and the patient will return for images on at least 1 and possibly 2 occasions     between 3-7 days after injection. If the case requires it, the patient may also be given a     steroid in tablet form, dexamethasone, to take orally prior to and after the injection to     suppress normal adrenal function so that the abnormal tissues can be more easily detected.   "
167946|NCT00037869|"     The goal of this clinical research study is to learn if I-131 Metaiodobenzylguanidine (MIBG)     can shrink or slow the growth of the tumor(s) in patients with metastatic neuroendocrine     tumors. The safety of this treatment will also be studied.   "
167947|NCT00037882|"     The purpose of this study is to determine if PEG-Intron is better tolerated and more     efficacious than standard interferons (Roferon, Intron) in patients with     Philadelphia-positive Chronic Myelogenous Leukemia. These patients should have previously     received standard interferon therapy and have been intolerant, resistant, or have relapsed     disease.   "
167948|NCT00037895|"     This project seeks to overcome the reduced walking capability, poor health status, decreased     functional capacity, and sedentary lifestyle of stroke patients. The specific objectives are     to compare the effects of regular inpatient stroke rehabilitation to regular rehabilitation     combined with STAT after an acute stroke on: a) gait performance; b) functional outcomes; c)     oxygen consumption during a seated task; and finally: d) using Brain Motor Control Assessment     to obtain neurophysiological characteristics, as possible predictors of rehabilitation     outcomes.   "
167949|NCT00037908|"     Our overall goal is to develop therapeutic interventions to improve upper-limb motor function     in hemiparetic persons based on an improved understanding of the mechanisms responsible for     its loss and recovery. We intend to rigorously evaluate the efficacy of these interventions     with clinical trials, and to study the mechanisms by which these interventions affect motor     recovery. In this proposal, we will use a controlled, randomized, double blind clinical trial     to study the effects of shoulder and elbow strength training in subjects in the subacute     phase of recovery following stroke.   "
167967|NCT00038142|"     Objectives:        1. To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and          Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free          survival seen with standard VAC therapy.        2. To evaluate the feasibility and describe the toxicity associated with VACdxr.        3. To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a          weekly basis for 50- 52 weeks.        4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.   "
167969|NCT00038168|"     Phase I: The goal of this clinical research study is to find the highest dose of estramustine     phosphate administered intravenously in combination with a fixed dose of Taxol (paclitaxel)     that can be given safely to participants with prostate cancer who have failed to further     benefit from hormone treatment.      Phase II: The goal of this clinical research study is to find out if the combination of the     drugs estramustine phosphate and paclitaxel will shrink or control prostate cancer that has     not responded to hormone treatment. A second goal is to find out if the side effects of these     drugs can be reversed. The safety of these drugs will also be studied.   "
167971|NCT00038194|"     The goal of this clinical research study is to find the highest safe dose of docetaxel in     combination with Gleevec (imatinib mesylate) that can be given to men with advanced     androgen-independent metastatic prostate cancer that involves bone. Docetaxel is a commercial     chemotherapy which interferes with the cancer cell ability to divide and grow.   "
167950|NCT00037921|"     Urinary tract infection (UTI) is the most common infection in patients with SCI and is a     major cause of morbidity and mortality in this population. The bladder of patients with SCI,     especially those who have indwelling catheters, is often colonized by bacteria that may or     may not cause symptoms of UTI. Bacteria that do not cause symptoms are usually considered     benign colonizers and are often left untreated because they may afford some protection     against symptomatic infection with more harmful bacteria.      We applied the concept of using benign bacteria to prevent symptomatic infection, so-called     bacterial interference, by deliberately colonizing the bladder of patients with SCI with a     non-pathogenic prototype of Escherichia coli (strain 83972). The preliminary results of our     VA-funded study that compared the rates of symptomatic UTI in patients with SCI while     colonized with E. coli 83972 vs. historical rates of symptomatic UTI prior to study     enrollment indicated that deliberate colonization of the bladder of patients with SCI with E.     coli 83972 is safe and very promising as to its ability to prevent symptomatic UTI. However,     before this innovative approach of bacterial interference can be successfully applied in the     population of patients with SCI, it is essential to: (A) confirm the ultimate efficacy of     bacterial interference by conducting a prospective, randomized, placebo-controlled clinical     trial (objective #1); and (B) enhance the practicality of applying this innovative approach     in SCI patients by delineating the bacterial and host factors that can promote successful     colonization with E. coli 83972 (objectives #2-3).   "
167951|NCT00037934|"     We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke     patients using a robot for neurological rehabilitation designed and built by MIT. Results of     a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated     by patients and produces a significant, measurable benefit. We propose to test that the     robotic upper extremity trainer is an acceptable cost effective adjunct to standard     occupational therapy for patients with dysfunction of the shoulder and elbow due to     hemiparetic stroke in a VA rehabilitation program.   "
167952|NCT00037947|"     We propose to evaluate auditory function and neuropsychologic function in 150 Multiple     Sclerosis (MS) patients and in 150 patients who do not have MS. Experimental subjects will be     recruited by selecting patients with a verified diagnosis of MS from the registry of patients     established by the Oregon Health Sciences University, Multiple Sclerosis Research Center.     Control subjects will be matched with respect to age, to gender and to audiometric     configuration.   "
167953|NCT00037960|"     We propose to develop and evaluate a workstation that significantly enhances the application     of Constraint-Induced (CI) Therapy by automating and instrumenting several of the tasks     currently used in the shaping training. The motivation for development of such a device is as     follows: 1) Patients could receive CI therapy at home without the need for constant     supervision from a therapist. Many veterans do not have the resources to travel to their     local VAMC for the two or three week period required for the treatment. A home-based device     would expand the pool of veterans who could receive CI therapy. 2) For subjects who were able     to receive CI therapy in the clinic, this device would facilitate an effective post-treatment     home-practice program. 3) Currently, patients are treated on a one-on-one basis in the     clinic. This device could allow one therapist to treat 3 or 4 patients at one time, thereby     substantially reducing the cost of the therapy. 4) This workstation would provide clear and     comprehensive quantification of the progress of the treatment. This could indicate on which     tasks the patient was progressing most and least rapidly, and would therefore enable     effective modifications of the treatment plan while treatment was in progress.      The hypothesis is that the positive outcomes of CI therapy can be achieved, and possibly     enhanced, if the shaping training component is performed in a workstation that guides,     motivates and records exercise of the more-affected limb. In the first 18 months, the     workstation will be designed and fabricated. To expedite the design, we will rely on simple     modifications to off the shelf components. In the last 18 months, a controlled, randomized,     clinical trial will compare the effectiveness of automated CI therapy programs with standard     CI therapy. The standard CI therapy group would receive shaping training in a clinical     setting, one-on-one with a therapist. The clinic-based automated CI therapy group would     perform the shaping training in the workstation, in a clinical setting and with minimal     supervision. The home-based automated CI therapy group would perform the shaping training at     home in the workstation, and with no direct supervision. All other aspects of the three     treatment programs will be identical. At the end of this 3-year project, a device will have     been designed, built and evaluated that could significantly enhance the application of CI     therapy for chronic stroke patients.   "
167954|NCT00037973|"     The primary objective of the study is to determine whether individuals with Chronic     Obstructive Pulmonary Disease (COPD) who complete ventilation-feedback training combined with     a moderately-high intensity exercise and upper body strength program will demonstrate     significantly longer exercise duration on a constant work rate treadmill test when compared     to subjects who are randomly assigned to a moderately-high intensity exercise and upper body     strength training program without ventilation-feedback or ventilation-feedback only.     Secondary study objectives are to determine whether individuals with COPD who complete     ventilation-feedback training combined with a moderately-high intensity exercise and upper     body strength training program will demonstrate significantly: (a) greater exercise tolerance     and aerobic power; (b) lower perception of breathlessness during progressive and constant     work rate leg-cycle and treadmill exercise testing; (c) higher tidal volume and lower     breathing frequency during constant work rate and at any given workload during progressive     testing; (d) lower score on the Chronic Respiratory Disease Questionnaire indicating improved     quality of life; (e) higher transition focal score (less dyspnea) on the Transition Dyspnea     Index; (f) maintain a sustained breathing-pattern adjustment to exercise when compared to     subjects who are randomly assigned to a moderately-high intensity exercise and upper body     strength program without ventilation-feedback or ventilation-feedback only.   "
167968|NCT00038155|"     Hospitalization for an acute medical condition often results in functional decline in older     adults. This loss of function often is not reversed after hospital discharge. Our general     hypothesis is that patients will benefit from rehabilitation that occurs simultaneously with     the medical management of acute conditions and when linked with a home exercise program that     can be implemented after discharge from the hospital. This approach differs from the     traditional approach of addressing rehabilitation needs after acute conditions have resolved     and providing rehabilitation services for selected patients in institutional settings, such     as subacute units or nursing homes. The feasibility of the program will be assessed by     documenting the participation of subjects during the inpatient phase and adherence of     subjects with the home-based program. Fifty subjects will be recruited from individuals who     are 60 years of age or older who have been admitted to the Birmingham Veterans Affairs     Medical Center (VAMC) for treatment of an acute medical condition. Subjects will be either     unable to ambulate, require assistance for ambulation, or be unable to ambulate a functional     distance (150 feet) at a functional velocity (30m/min). Subjects will be randomly assigned to     a physical rehabilitation group (PR) or to a control group (CON). During hospitalization,     subjects in the PR group daily will have one 45-minute morning rehabilitation session and one     30-minute evening rehabilitation session. Both sessions will include ambulation and transfer     training. The longer morning session will also include resistance exercise. Subjects in the     CON group will have medial care as it is currently provided. During the six months after     discharge, subjects in the PR group will perform a home-based exercise program consisting of     ambulation and resistance exercises. The program will be monitored and progressed by an     exercise physiologist who will visit subjects weekly for the first month after discharge,     every other week for the second and third months after discharge, and monthly in the fourth,     fifth, and six months after discharge. This study is designed to test the feasibility and     effectiveness of a practical and potentially cost-effective rehabilitation program.   "
168001|NCT00038597|"     The goal of this research is to see if giving the drug SCH66336 by mouth can improve the     disease in patients with chronic or accelerated phase CML. The safety of this treatment will     also be studied.   "
167955|NCT00037986|"     The short-term research objectives of the proposed study are as follows:        1. To measure the effects of audiological intervention on selected domain specific (i.e.,          Communicative, Interpersonal, and Social roles) and overall functioning using the          WHO-DASII, a generic health measure conceptually grounded in the ICIDH-2 model of          disablement and functioning.        2. To measure the effects of audiological intervention on selected domain specific (i.e.,          Role Functioning-Emotional; and, Social Functioning) and overall functioning using the          MOS-SF36V, a generic health measure currently utilized in the Veteran's Health          Administration.        3. To determine the accuracy with which measures of audibility (SII), hearing handicap          (HHIE), and, hearing disability (APHAB) predict domain specific and overall functioning,          and life-satisfaction as measured by the WHO-DASII and the MOS-SF36V will be evaluated.        4. To compare hearing aid treatment effects as measured by changes in WHO-DASII domain          specific and overall functioning scores to those measured by changes in disease specific          instruments examining similar constructs.        5. To compare hearing aid treatment effects as measured by changes in MOS-SF36V domain          specific and overall functioning scores to those measured by changes in disease specific          instruments examining similar constructs.        6. To determine and compare cost-effectiveness of hearing aid intervention as calculated          using WHO-DASII and MOS SF-36V outcome data.      The long-term research objective is to compare the cost-effectiveness and cost-utility of     audiologic intervention with those of other health care interventions commonly associated     with the veteran population (e.g. mental health, cardiology, pulmonary, orthopedic, etc.).   "
167956|NCT00037999|"     The objective of this project is to determine the safety and efficacy of testosterone     supplementation as an adjunct to traditional rehabilitation therapy in the care of     deconditioned older men. Our long range goal is to determine whether other hormones (e.g.,     combined testosterone and growth hormone) are helpful as an adjunct to traditional     rehabilitation therapy.      This project is important to the VA health care system because 38% of American veterans are     aged (age > 65 years), bioavailable testosterone is diminished in older age men, low     testosterone is associated with impaired muscle strength, and lack of muscle strength hinders     rehabilitation. Older men who are not successfully rehabilitated often get admitted to     nursing homes for long term care, at a cost of approximately $40,000/year. Payment for long     term care is currently one of our most difficult health care problems. If testosterone     supplementation improves rehabilitation outcomes, as our pilot data suggest it will, patients     will be more satisfied and long-term care financial resources will be saved.      We will conduct a randomized, placebo-controlled trial to test the hypothesis that     supplementation with testosterone improves rehabilitation outcomes in deconditioned older     men. Specifically, we will screen all hospitalized older men with delayed discharge from the     hospital (> 7 day hospital stay). Men who have at least one new impairment in their ability     to perform activities of daily living (e.g., inability to walk), low serum testosterone     concentration, and no contraindications (e.g., prostate or breast cancer) will be offered the     opportunity to participate. Study participants will be randomized to receive either     testosterone (5 mg transdermally each night) or placebo (matching transdermal patch) daily in     a double-blind fashion for the duration of their hospital course (expected average duration     of study is 29 days). Subjects will then receive their rehabilitation as usual, with all     members of the health care team blinded as to whether the subject is receiving testosterone     or placebo. At baseline, weekly, at discharge, and at 6 and 12 months after discharge,     subjects will be assessed using validated measures (i.e., Functional Independence Measure -     FIM). Our hypothesis is that testosterone supplementation, as an adjunct to traditional     rehabilitation therapy, will improve rehabilitation outcomes.   "
167957|NCT00038012|"     A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with     ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin   "
167958|NCT00038025|"     The purpose of this study is to determine the side effects and antitumor response of patients     with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.   "
167959|NCT00038038|"     The purpose of this clinical research study is to answer the following questions using     18F-fluoromisonidazole as an imaging agent:        1. Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)?        2. If hypoxic cells exist in human tumors, do they effect the ability of radiotherapy to          control human tumors?        3. Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?   "
167960|NCT00038051|"     The goal of this clinical research study is to find the highest safe dose of the anti-CD33     immunotoxin HuM-195/rGel that can be given to patients with advanced myeloid malignancies.     This treatment will be given to patients whose leukemia has not responded to prior     chemotherapy.   "
167961|NCT00038064|"     Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red     blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and     shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone     marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in     the laboratory and has the same effect as the hormone produced by the body. Use of     recombinant human erythropoietin allows the body to produce more red blood cells, possibly     eliminating or decreasing your symptoms and the need for a red blood cell transfusion.     Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving     chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for     the treatment of anemia in patients with non-myeloid malignancies who are receiving     multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that     stimulates the production of red blood cells. This medication has not been approved to treat     cancer patients with anemia, however it has been approved by the FDA to treat chronic renal     failure patients with anemia.   "
167962|NCT00038077|"     The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in     asymptomatic heart failure subjects will improve their heart structure and thus prevent the     progression to symptomatic disease.   "
167963|NCT00038090|"     Objective is to assess the activity of the combination of thalidomide and dexamethasone in     patients with previously untreated multiple myeloma.   "
167964|NCT00038103|"     This is an open-label, multicenter, randomized (1:1 randomization ratio) study of either     exemestane or exemestane plus celecoxib in postmenopausal women with ABC having progressed on     tamoxifen.   "
167965|NCT00038116|"     The purpose of this trial is to determine if patients who received embryonic dopamine cell     implant surgery showed significantly greater improvement in their Parkinson's disease than a     control group undergoing the placebo treatment, and to determine if the cell implant surgery     was more effective in younger or older patients.   "
167966|NCT00038129|"     The purpose of this study is to determine if there is a difference in the rate of healing of     a tibia fracture treated with an intramedullary nail based on whether or not the bone was     reamed prior to nail insertion.   "
168634|NCT00035776|"     To investigate associations between hemostatic and inflammatory blood factors and progression     of lower extremity arterial ischemia and cardiovascular events in men and women with and     without lower extremity peripheral arterial disease.   "
167976|NCT00038259|"     When an HIV infected person taking strong anti-HIV drugs temporarily stops taking them, viral     load rises and the body's immune system is exposed to more HIV. This may lead to the body     mounting a better immune response against the virus. The purpose of this study is to find out     if taking interleukin-2 (also called IL-2 or aldesleukin) while stopping anti-HIV drugs for     short periods of time can help patients control their HIV viral load.      Study hypothesis: Patients in this study will have lower virologic rebound and will maintain     their CD4 cell counts for a longer time than other patients in comparative studies.   "
167977|NCT00038272|"     The purpose of this study is to evaluate the safety, efficacy, and side effects of     beta-D-2,6-diaminopurine dioxolane (DAPD) compared to DAPD plus mycophenolate mofetil (MMF)     when these drugs are added to the anti-HIV treatment regimens of people infected with HIV.      Some studies have shown that DAPD and MMF can help fight HIV. However, neither DAPD nor MMF     has been approved by the Food and Drug Administration for treating HIV infection. This study     will help doctors decide if DAPD and MMF are good drugs for treating HIV.   "
167978|NCT00038285|"     In the VA, we are achieving progress in decreasing amputation rates through early     identification and multidisciplinary treatment of patients at risk for limb loss. Despite     these accomplishments, however, clinical outcomes post-amputation, especially for PVD     patients, have changed little because of patients' poor cardiovascular condition complicated     by the injurious consequences of imposed inactivity begun in the preoperative period and     continuing through convalescence. If not aggressively managed throughout all phases of     recovery, these problems quickly render patients, already at risk, incapable of the rigors of     rehabilitation as well as lead to reamputation, rehabilitation failure, and secondary     complications. In our research, we are trying to transform this clinical scenario by applying     what has succeeded in cardiac rehabilitation to services provided to amputees. In a series of     studies, we are studying how to incorporate secondary CV risk factor modification and     aggressive exercise interventions into conventional amputation rehabilitation through a     program that we have named Healthy Heart Amputation Rehabilitation Therapy (Healthy     H.A.R.T.). Our goal is to better: 1) increase aerobic capacity and promote rehabilitation     achievements and quality of life, and 2) prevent postoperative complications and curtail     further peripheral vascular deterioration through interventions found successful in cardiac     rehabilitation. The basic assumption of this study will be that cardiovascular status and,     thus, aerobic capacity is a most critical factor for rehabilitation success.   "
167979|NCT00038298|"     This clinical study is investigating AMG 719, an investigational drug, for the treatment of     patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug     which is self-injected beneath the skin (similarly to the way insulin is self-injected by     diabetics). Patients on this study are on study for 28-weeks. They visit the study facility     at least 11 times while participating in the study.   "
167980|NCT00038311|"     Intensive chemotherapy is associated with significant thrombocytopenia, often requiring     platelet transfusion to maintain platelet counts. This investigational drug has demonstrated     the ability to increase platelet counts. This study will test the safety and efficacy of an     investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma     receiving AI (Adriamycin/Ifosfamide) chemotherapy.   "
167981|NCT00038337|"     The objective of this two parallel component study is to develop interventions for the visual     and cognitive related health literacy disabilities of older veterans. The first component     will test two interventions for improving functional health literacy performance (enhancing     the design of health literacy materials and training reading skills) by using a 2 x 2 between     subjects factorial design. The second component consists of patient, family, and provider     focus groups who will help determine where to apply and disseminate the interventions by     identifying problematic sources of text-based health materials. Finally, as a result of both     components improved health information design guidelines and training protocols will be     developed as rehabilitative interventions for health literacy disability.   "
167982|NCT00038350|"     The long-term goal of this research program is to advance the treatment of swallowing     disorders in elderly adults. This study will identify the impact of an 8-week progressive     resistance exercise program for oral muscles on swallowing physiology, anatomy, dietary     intake, and Quality of Life (QOL) in frail dysphagic adults. Findings from the exercise     program may indicate new directions for treatments and techniques designed to influence the     biological underpinnings of dysphagia in elderly persons. Translation of these findings into     clinical practice will have far-reaching significance in the fields of gerontology, speech     language pathology, and long-term care.   "
168002|NCT00038610|"     The goal of this clinical research study is to learn if intensive chemotherapy, combined with     imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by     maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate     indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of     this treatment will also be studied.   "
167983|NCT00038363|"     The proposed study objective is to compare hospital-based rehabilitative care with     transitional subacute rehabilitation for adults recently diagnosed with a disabling disorder.     Clinical outcomes, cost and utilization of services will be compared in order to test the     hypotheses that medically-stable patients receiving rehabilitation from subacute care     facilities will: 1) function as well physically, 2) report less family dysfunction, 3) have     better psychological adjustment and well-being than controls who receive only hospital-based     inpatient care, and 4) receive services at lower cost. We intend to assess the impact of     hospital-based versus subacute care on clinical and cost outcomes at admission, discharge [3     months post-admission] and at 12 months. The first set of analyses will determine predictors     of physical function, family function, psychological adjustment and well-being over a 1 year     period.   "
167984|NCT00038376|"     The purpose of this study is to determine the response rate of patients with T-cell     malignancies to combination therapy using interferon-alpha (Roferon) and Isotretinoin     (Accutane).   "
168010|NCT00038714|"     Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and     can obstruct the airway or become malignant. The cause has been related to specific types of     Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness     of a trial drug, SGN-00101, in children with RRP and also assess its safety.   "
167985|NCT00038389|"     It is of interest to determine whether COX-2 inhibitors given with radiation therapy can     prolong the progression-free survival in brain stem glioma. Diffuse pontine brainstem gliomas     are more common in children, but are also seen in adults. However, the use of commercially     available COX-2 inhibitors has not been evaluated in the pediatric population and the proper     dosing in pediatrics is unknown. Therefore a Phase I study will need to be conducted as a     first step. Rofecoxib is an FDA approved COX-2 inhibitor for use in adults. This phase I     study is designed to determine the maximum tolerated dose of Rofecoxib given concurrently     with standard radiation therapy for diffuse pontine brainstem glioma.   "
167986|NCT00038402|"     The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy     treatment of patients newly diagnosed with operable breast cancer.      Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the     tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of     this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side     effect profile with the addition of Herceptin, and 4) evaluate significance of HER2     expression by two different methods.   "
167987|NCT00038415|"     The goal of this clinical research study is learn if a vaccine that contains the patient's     own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia     (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine     will be studied. This is a dose escalation study in which each patient will receive vaccine     at one dose level. Patients will be injected with a fragment of Deoxyribonucleic acid (DNA)     containing the sequence of their own immunoglobulin gene. Patients will be required to have     their diagnosis of CLL and stage confirmed prior to initiating vaccination. After vaccination     patients will receive clinical and immunologic evaluation, including both humoral and     cellular responses. The investigator will be assessing the patient's immune response or     whether the patient's body recognizes the DNA vaccine. In addition, side effects and     reactions to the vaccine will be evaluated.   "
167988|NCT00038428|"     The purpose of this study is to determine the effectiveness and safety of TLK286 given     intravenously once every week in the treatment of patients with advanced ovarian cancer that     is resistant to platinum-based chemotherapy.   "
167989|NCT00038441|"     This is a clinical research study of a new investigational treatment for cancer called     DTI-015 to be given by intratumoral injection. Intratumoral injection is when drug is     injected directly into the tumor. This study will help doctors find out what is the best dose     level for DTI-015 and if this treatment can shrink tumors without causing severe side     effects. The effects of the drug on the patient's quality of life (how the patient feels and     what the patient can do) and their mental functions (reasoning and thinking abilities) will     also be studied.   "
167990|NCT00038454|"     To evaluate the efficacy of Hemolink™ in combination with Intraoperative Autologous Donation     (IAD) versus control (IAD alone) in facilitating avoidance of allogeneic RBC transfusion     during and following primary CABG surgery   "
167991|NCT00038467|"     To compare the sequential administration of exemestane with administration of further     tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already     received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall     survival (OS), incidence of contralateral breast cancer and long-term tolerability.   "
167992|NCT00038480|"     The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe     and well tolerated in HIV infected infants. This study will also determine the most effective     dose of LPV/RTV for infants.   "
167993|NCT00038493|"     This study will combine the chemotherapy agent temozolomide with the investigational drug     SCH66336 (an agent which interferes with new cell growth). Patients will be treated with oral     temozolomide on days 1-5 and oral SCH66336 on days 8-28 every 28 days.   "
167994|NCT00038506|"     This study is a 48-week study to evaluate the efficacy and safety of an investigational     regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on     their first highly active antiretroviral therapy regimen.   "
167995|NCT00038519|"     The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or     saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second     protease inhibitor based HAART.   "
167996|NCT00038532|"     The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz     in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first     protease inhibitor based HAART.   "
167997|NCT00038545|"     For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma   "
167998|NCT00038558|"     Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD     chemotherapy.   "
167999|NCT00038571|"     Purpose of Phase II study for B-cell lymphoma using PS341: Evaluate efficacy and toxicity of     bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.   "
168000|NCT00038584|"     SCH66336 is a drug that has been designed to block the growth of tumor cells and encourage     tumor cell death.      This is a randomized study where patients will receive study drug or no drug. Participants in     this study are scheduled to have surgery to remove head and neck cancer.   "
168003|NCT00038623|"     Study of Yttrium-ibritumomab (Zevalin) For the treatment of Patients with Relapsed &     Refractory Mantle Cell Lymphoma   "
168007|NCT00038675|"     The goal of this clinical research study is to see if Gleevec, known as imatinib mesylate     (STI571), can improve the disease condition in patients with hypereosinophilic syndrome,     polycythemia vera, atypical CML or CMML with PDGF-R fusion genes, or mastocytosis.   "
168008|NCT00038688|"     Injection drug use is the major mode of HIV transmission in many countries. Injection drug     users (IDUs) transmit HIV not only through shared drug injection equipment but also through     heterosexual and homosexual transmission and mother-to-child transmission. Studies have shown     that peer education programs can reduce HIV risk behavior in IDUs. However, it is not known     if reduced HIV risk behavior leads to fewer HIV infections. The purpose of this study is to     find out if a peer education program can reduce the number of new HIV infections by changing     the behavior of IDUs and their HIV risk contacts.   "
168009|NCT00038701|"     The goal is to assess survival and patterns of failure in patients treated with Gemzar-based     chemoradiation and TNP-470 for locally advanced adenocarcinoma of the pancreas.   "
168011|NCT00038727|"     The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an     intensive lifestyle or metformin to prevent or delay the development of diabetes in a high     risk population due to the presence of impaired glucose tolerance (IGT). The DPP has ended     early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced     diabetes onset by 31%.      The DPPOS is designed to take advantage of the scientifically and clinically valuable DPP     participants. This group of participants is nearly 50% minority and represents the largest     IFG/IGT population ever studied. Clinically important research questions remain that focus on     1) durability of the prior DPP intervention, 2) determination of the clinical course of     precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk     factors and atherosclerosis, 3) close examination of these topics in men vs women and in     minority populations.   "
168012|NCT00038753|"     To identify vision-screening tests that can accurately predict those three- and four-year old     preschoolers who would benefit from a comprehensive vision examination because of signs of     amblyopia, strabismus, and/or significant refractive error.   "
168013|NCT00038766|"     The purpose of this study is to determine whether CNI-1493 is safe and effective in the     treatment of moderate to severe Crohn's Disease.   "
168014|NCT00038779|"     The purpose of this study is to assess early treatment failure within 100 days and to assess     the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and     survival.   "
168015|NCT00038792|"     Phase II efficacy evaluation, phase I/II efficacy and toxicity trial of recombinant human     keratinocyte growth factor for the treatment of steroid refractory gastrointestinal graft     versus host disease.   "
168016|NCT00038805|"     Primary Objective:      To determine the safety and maximum tolerated dose of CMA-676 as part of an intensive but     nonmyeloablative preparative regimen in older or medically infirm patients undergoing     mini-allogeneic peripheral blood stem cell transplantation      Secondary Objectives:        1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with          this strategy.        2. To evaluate disease-free and overall survival and relapse rates.        3. To evaluate the need and ability to give multiple cycles of Mylotarg plus FA and          mobilized DLI in patients not achieving complete remission.   "
168017|NCT00038818|"     Primary Objectives:      To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8     depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic     leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple     Myeloma (MM) and Hodgkin's Lymphoma (HD).      Secondary Objectives:        -  To evaluate safety and treatment related mortality after CD8 depleted DLI.        -  To evaluate the time to onset of GVHD following DLI and response to GVHD treatment.        -  To evaluate the incidence and timing of pancytopenia following DLI.        -  To evaluate disease-free survival, overall survival and relapse rates in three cohorts          of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD,          CLL, NHL and MM).        -  To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte          infusions.        -  To evaluate the number of apheresis procedures needed to collect appropriate doses of          CD4+ cells.   "
168018|NCT00038831|"     The goal of this clinical research study is to find the highest safe dose of Mylotarg that     can be combined with chemotherapy in patients receiving allogeneic bone marrow     transplantation. Researchers will study the effects of this treatment combination on patients     with high-risk acute leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome.      Primary Objective:      1. To determine the safety and maximum tolerated dose of Mylotarg as part of a     reduced-intensity preparative regimen patients undergoing related, mismatched-related or     matched unrelated donor transplantation.      Secondary Objectives:        1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with          this strategy.        2. To evaluate the incidence and severity of GVHD in this population        3. To evaluate disease-free and overall survival and relapse rates.   "
168019|NCT00038844|"     Objective of the low-dose transplant regimen must produce the following effects:        1. Suppression of the patient's immune system to prevent rejection of the donor cells;        2. Control of the lymphoma. The pretransplant regimen must suppress the lymphoma          sufficiently to prevent marked progression of the tumor and allow time for the GVT          effect to occur.   "
168020|NCT00038857|"     Donor:      This clinical study will evaluate the feasibility of a purified CD34 peripheral blood     progenitor cell (PBPC) transplants in patients with hematological malignancies.      The primary objectives of the study are to evaluate the recipient obtaining donor derived     neutrophil engraftment and the incidence of acute graft versus host disease [GvHD] (grade     III-IV).      Secondary objectives include assessments of recipient having donor derived platelet     engraftment, incidence of graft failure and chronic GvHD, overall and disease free survival,     clinical safety and device performance of the CliniMACS CD34 selection device.   "
168021|NCT00038870|"     1. Determine the feasibility of generation of autologous Acute Myelogenous Leukemia (AML)          or Chronic Myelogenous Leukemia in myeloid blast crisis (CML/BC) derived dendritic cell          activated lymphocytes (DC/AL) in poor prognosis patients.        2. Determine the toxicity of autologous leukemia derived dendritic cell activated          lymphocytes (DC/AL) in patients with AML or CML/BC.        3. Quantitate circulating immune effector cells in patients after infusion of DC/AL.        4. Record the efficacy of AML or CML/BC derived dendritic cells and activated lymphocytes          in promoting and sustaining remission in patients with AML or CML/BC.   "
168022|NCT00038883|"     High dose chemotherapy followed by transplantation of allogeneic hematopoietic stem cell with     the use of Campath-1h, a monoclonal antibody that have a synergistic effect to chemotherapy     with minimal toxicity. In addition Campath-1H can improve engraftment of donor cells through     its immunosuppressive properties.   "
168023|NCT00038896|"     The primary objective of this study is to determine the efficacy, safety, and tolerability of     a flexible dose of venlafaxine extended-release (ER) capsules administered for 10 weeks in     the treatment of adult outpatients with panic disorder (PD) in a placebo-controlled phase III     study.   "
168024|NCT00038909|"     To identify the causative mutations in previously untreated patients with hemophilia A     enrolled in the ReFacto® clinical safety and efficacy study CTN 93-R833-0XX/C9741-28, using     two established hemophilia mutation testing laboratories (one in Europe and one in North     America).   "
168029|NCT00038974|"     This study is designed to test the hypothesis that African-Americans respond less well to     combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have     chronic hepatitis C genotype 1 and who were not previously treated with either interferon or     ribavirin. Reasons for differences in response, regardless of race, will be studied.   "
168030|NCT00038987|"     To define the safety of vaccination with APSV as determined by the reactogenicity of the     vaccine and the development of expected and un-expected adverse events associated with     vaccination.      To assess the proportion of individuals who respond to vaccination with a take (those who     form a visible lesion at the injection site) 6 to 8 days after the vaccination.   "
168031|NCT00039000|"     The primary goal of this study is to determine if people with metastatic melanoma who receive     Heat Shock Protein-Peptide Complex - 96 (HSPPC-96 or Oncophage) after surgery live longer     than people who may or may not have surgery but who receive conventional chemotherapy     including IL-2/DTIC. A second goal is to determine the safety and frequency of side effects     in subjects who receive therapy with HSPPC-96.   "
168032|NCT00039013|"     This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on     glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients     will be randomized into one of two AC2993 treatment arms or to placebo treatment and will     continue with their required existing diabetes medication (metformin) throughout the study.   "
168033|NCT00039026|"     This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on     glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients     will be randomized into one of two AC2993 treatment arms or to placebo treatment and will     continue with their required existing diabetes medication (sulfonylurea) throughout the     study.   "
168034|NCT00039039|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Drugs such as paclitaxel may make tumor cells more sensitive to radiation therapy. It is not     yet known if combination chemotherapy followed by radiation therapy is more effective with or     without paclitaxel in treating unresectable stage III non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     followed by radiation therapy with or without paclitaxel in treating patients who have     unresectable stage III non-small cell lung cancer.   "
168035|NCT00039052|"     RATIONALE: Interleukin-4 PE38KDEL cytotoxin may be able to deliver cancer-killing substances     directly to solid tumor cells.      PURPOSE: Phase I trial to study the effectiveness of intravenous interleukin-4 PE38KDEL     cytotoxin in treating patients who have recurrent or metastatic kidney cancer, non-small cell     lung cancer, or breast cancer that has not responded to previous treatment.   "
168036|NCT00039078|"     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near     a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be     effective treatment for liver cancer that cannot be removed by surgery.      PURPOSE: This phase II trial is studying the side effects of hepatic arterial infusion using     yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with     liver cancer that cannot be removed by surgery.   "
168037|NCT00039091|"     This phase I trial is studying the side effects of monoclonal antibody therapy in treating     patients with ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic     syndrome, or non-small cell lung cancer. Monoclonal antibodies can locate tumor cells and     either kill them or deliver tumor-killing substances to them without harming normal cells   "
168038|NCT00039104|"     Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in     treating patients who have prostate cancer that has not responded to previous hormone     therapy. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone.     BMS-275291 may stop the growth of tumor cells by blocking the enzymes necessary for cancer     cell growth. Combining zoledronate with BMS-275291 may kill more tumor cells.   "
168039|NCT00039117|"     Phase I trial to study the effectiveness of combining oblimersen with cytarabine and     daunorubicin in treating older patients who have previously untreated acute myeloid leukemia.     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Oblimersen may help cytarabine and daunorubicin kill more cancer cells by     making them more sensitive to chemotherapy.   "
168040|NCT00039130|"     RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Colony-stimulating factors such as filgrastim may increase the numbers of immune cells     found in bone marrow or peripheral blood and may help a person's immune system recover from     the side effects of chemotherapy. Combining chemotherapy with rituximab and filgrastim may     kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy     and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.   "
168041|NCT00039156|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who     have refractory non-Hodgkin's lymphoma.   "
168042|NCT00039169|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who     have advanced kidney cancer.   "
168043|NCT00039182|"     Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This     phase II trial is studying how well erlotinib works in treating patients with malignant     mesothelioma of the lung   "
168083|NCT00039390|"     This phase I trial is studying the side effects and best dose of gefitinib and capecitabine     in treating patients with advanced solid tumors. Biological therapies such as gefitinib may     interfere with the growth of tumor cells and slow the growth of solid tumors. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining gefitinib and capecitabine may kill more tumor cells   "
175921|NCT00137202|"     The purpose of this study is to see if a drug called ondansetron (Zofran) controls itching     from healing burn wounds as well or better than the usual drug used, diphenhydramine     (Benadryl).   "
168044|NCT00039195|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells     and either kill them or deliver cancer-killing substances to them without harming normal     cells. Combining chemotherapy with monoclonal antibody therapy, total-body irradiation, and     peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy     drugs and kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving chemotherapy with rituximab followed     by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral     stem cell transplant works in treating patients with lymphoma.   "
168045|NCT00039208|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving drugs at the time of day that allows for the best drug     response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor     cells.      PURPOSE: Randomized phase II trial to determine the best time to give irinotecan combined     with fluorouracil, leucovorin, and oxaliplatin in treating patients who have colorectal     cancer.   "
168046|NCT00039234|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.     Histamine dihydrochloride may help interleukin-2 kill more tumor cells by making tumor cells     more sensitive to the drug. It is not yet known if interleukin-2 is more effective with or     without histamine dihydrochloride in treating stage IV melanoma that is metastatic to the     liver.      PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with or     without histamine dihydrochloride in treating patients who have stage IV melanoma that is     metastatic to the liver.   "
168047|NCT00021294|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Eflornithine with or without triamcinolone may be     effective in preventing nonmelanoma skin cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of eflornithine with or     without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic     keratosis.   "
168048|NCT00021307|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus carboplatin in     treating patients who have recurrent glioblastoma multiforme.   "
168049|NCT00021320|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or     without radiation therapy in treating patients who have esophageal cancer.   "
168050|NCT00021333|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may make tumor cells more sensitive to     radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of paclitaxel and cisplatin plus radiation     therapy followed by filgrastim in treating patients who have recurrent head and neck cancer     or lung cancer.   "
168051|NCT00021346|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and gemcitabine in     treating patients who have advanced solid tumors.   "
168052|NCT00021359|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with dexamethasone may be an effective     treatment for multiple myeloma.      PURPOSE: Phase II trial to study the effectiveness of combining isotretinoin and     dexamethasone in treating patients who have multiple myeloma.   "
168053|NCT00021372|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and estramustine     in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.   "
168095|NCT00039559|"     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective     treatment for ovarian cancer.      PURPOSE: Screening trial to determine the significance of cancer antigen 125 (CA125) levels     in detecting ovarian cancer in participants who have a high genetic risk of developing     ovarian cancer.   "
168054|NCT00021385|"     RATIONALE: Squalamine lactate may stop or slow the growth of ovarian cancer by stopping blood     flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. Combining squalamine lactate with carboplatin may kill     more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining squalamine lactate and     carboplatin in treating patients who have recurrent or refractory stage III or stage IV     ovarian cancer.   "
168055|NCT00021398|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining radiation therapy and chemotherapy may shrink the tumor so that it can be     removed during surgery.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy     followed by surgery and combination chemotherapy in treating patients who have stage II or     stage III rectal cancer.   "
168056|NCT00021424|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who     have stage IV head and neck cancer.   "
168079|NCT00039338|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so     that it can be removed during surgery. Radiation therapy uses high-energy x-rays to kill     tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is     not yet known whether chemotherapy is more effective followed by surgery or combined with     radiation therapy in treating cervical cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by     radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients     who have stage IB or stage II cervical cancer.   "
168057|NCT00021437|"     Since 1960, persons with the very rare disorder Bloom's syndrome (BS) have been followed     clinically, documenting clinical matters as obtained from their doctors. This has been a     worldwide search for cases, though a few in the New York City area are seen (personally, by     us) perhaps once every 2-3 years. BS is a rare genetically-determined disorder described in     NYC in 1954. The clinical courses of the 169 persons diagnosed BS by 1991 are followed in a     program referred to as the Bloom's Syndrome Registry. BS is the prototype of the     chromosome-breakage syndromes. BS cells mutate at a greater rate than any other, and the     consequence is the greatest known predisposition to cancers of the types that affect the     general human population. We are defining the clinical syndrome and at the same time are     studying cells from affected families in the experimental laboratory. BS is a model for     learning about cancer. Our contact with families lets us know of cancers arising, but blood,     and sometimes tiny biopsies of skin, is taken if available so that (a) the chromosomes can be     studied and (b) the gene mutations can be defined in molecular terms.   "
168058|NCT00021450|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and     goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet     known if radiation therapy is more effective with or without bicalutamide and goserelin in     treating prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without bicalutamide and goserelin in treating patients who have localized prostate cancer.   "
168059|NCT00021463|"     The purpose of this study is to learn whether changing from a type of anti-HIV drug called a     protease inhibitor (PI) to another type of anti-HIV drug will help to lower the amount of     fats or sugars in the blood.      PIs have been effective at keeping HIV viral load (amount of HIV in the blood) down. However,     some people who take PIs have higher than normal levels of fats and/or sugars in the blood.     Doctors believe that switching to anti-HIV drugs that do not contain PIs will improve the     abnormal side effects. This study will test 3 different combinations of non-PI drugs to see     which may improve side effects while keeping viral loads low.   "
168060|NCT00021476|"     This study is aimed at developing ways to prevent acute pain from becoming chronic     pain--specifically, pain associated with whiplash-associated disorders (WADs) from motor     vehicle accidents. Research on the development of chronic pain due to musculoskeletal injury     suggests that a person's initial emotional reactions, particularly fear of reinjury and     subsequent avoidance of activity, contribute significantly to chronic pain and persistent     disability. This study will treat people with WADs during the first three months after a     motor vehicle accident with a behavioral and physical exercise program designed to encourage     activity and discourage continued fear of movement, pain, and disability. The study will     compare the effectiveness of two anxiety-reduction treatments to standard care in reducing     pain and activity limitations in people with WADs in the 2 to 3 months after motor vehicle     accidents.   "
168061|NCT00021489|"     The purpose of this study is to learn how safe and well-tolerated mycophenolate mofetil (MMF)     is when given with abacavir (ABC). Another purpose is to see if adding MMF to ABC decreases     viral load (amount of HIV in the blood) more than ABC alone.      Many HIV-infected patients who have had heavy exposure to anti-HIV drugs and have experienced     treatment failure need new treatment combinations. One promising combination is ABC and MMF     as part of a drug combination. Laboratory studies show that MMF helps ABC destroy HIV in the     cells and further clinical testing is needed. MMF is not FDA-approved as a treatment for HIV     infection but has been approved by FDA to prevent rejection of organ transplants. Doses of     MMF tested in this study will be lower than those used to treat people with organ     transplants.   "
168062|NCT00021502|"     To determine the safety and effectiveness of pyridoxylated hemoglobin polyoxyethylene     conjugate (PHP) administered by continuous intravenous (IV) infusion in systemic inflammatory     response syndrome (SIRS) patients with shock. PHP is a human-derived chemically modified     hemoglobin preparation. PHP selectively scavenges excess nitric oxide (NO) and does so in a     catalytic, concentration-dependent reaction that results in the formation of the non-toxic NO     metabolite, nitrate. PHP is postulated to reduce excess, toxic levels of NO while allowing     critical beneficial levels of the molecule to persist.   "
168063|NCT00021528|"     STAR*D focuses on non-psychotic major depressive disorder in adults who are seen in     outpatient settings. The primary purpose of this research study is to determine which     treatments work best if the first treatment with medication does not produce an acceptable     response. Participants will first receive citalopram, an SSRI medication; if symptoms remain     after 8-12 weeks of treatment, up to four other levels of treatment will be offered,     including cognitive therapy and other medications. There are no placebo treatments. Some     patients may require a combination of two or more treatments to obtain full benefit.     Participation could last from 15 to 27 months and involve up to 30 clinic visits.     Participants will be interviewed by telephone throughout the study about their symptoms,     daily functioning, treatment side effects, use of the health care system, and satisfaction     with treatment. There will be a one-year follow up for participants once their depression has     been successfully treated   "
173400|NCT00111761|"     The purpose of this study is to determine if panitumumab, in combination with irinotecan,     leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic     colorectal cancer.   "
168080|NCT00039351|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     older patients who have non-Hodgkin's lymphoma.   "
168081|NCT00039364|"     RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth     of the tumor.      PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients     who have gliomas.   "
168082|NCT00039377|"     This phase II trial studies how well giving imatinib mesylate together with chemotherapy and     peripheral stem cell transplantation works in treating patients with newly diagnosed acute     lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells     from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer     cells by blocking the enzymes necessary for cancer cell growth. Giving imatinib mesylate     together with chemotherapy and peripheral stem cell transplantation may be an effective     treatment for acute lymphoblastic leukemia.   "
168064|NCT00021541|"     This study will examine whether the experimental drug R115777 (Tipifarnib) can shrink or slow     the growth of plexiform neurofibromas in children and young adults with neurofibromatosis     type 1 (NF1) and determine what side effects are related to treatment. Plexiform tumors arise     from nerves; the only effective treatment is surgical removal. Often, however, not all the     tumors can be removed, because of their number or location.      Patients with NF1 have a reduced amount of the protein neurofibromin. Neurofibromin is     thought to help control the activity of another protein, called ras, which regulates cell     growth. Too little neurofibromin, therefore, may allow for uncontrolled cell growth and tumor     formation. R115777 interferes with the function of the ras and other proteins. In test tube     and animal studies, R115777 has blocked the growth of cancer cells. This study will examine     whether the drug is effective against plexiform tumors.      Patients with NF1 and progressive plexiform neurofibromas between 3 and 25 years of age may     be eligible for this study. Patients whose tumors can be successfully removed surgically may     not participate in this study. Candidates are screened with a medical history and physical     and eye examinations, blood and urine tests, and magnetic resonance imaging (MRI).     Photographs are taken of tumors visible on the body surface.      Study participants are randomly assigned to receive either R115777 or placebo (an inactive     substance). They take R115777 or placebo tablets every 12 hours for 21 days, followed by a     7-day rest period. This constitutes one 28-day treatment cycle. Treatment continues for as     long as the tumors remain stable or shrink and side effects are tolerable. The treatment is     switched (for example, from placebo to R115777) or stopped if the tumors grow or if side     effects become unacceptable. Patients (or their parents) keep a record of side effects.      For the first 3 treatment cycles, patients have a physical examination and blood tests every     other week. Blood tests are also done before starting treatment, and at one time point after     at least 14 days of treatment to measure the effect of R115777 on proteins in blood cells. A     blood sample is obtained before starting treatment and before cycles 4, 7 and 10 and then     after every 6 cycles to measure the level of a substance called nerve growth factor. The     analysis of nerve growth factor is used to determine if it can predict which patients might     be at risk of developing side effects from R115777.   "
168065|NCT00027352|"     The purpose of this study is to compare two ways of using anti-HIV drugs to help health care     providers and patients decide how to best use anti-HIV treatments over many years. Many     health care providers now treat patients with daily drugs to keep the viral load as low as     possible. This approach helps patients with CD4 counts less than 200-250 cells/mm3 live     longer without serious diseases. But it is not known if this is the best way to treat     patients with higher CD4 counts. There is information suggesting that these patients may be     able to wait to use anti-HIV drugs while CD4 counts are above 250 cells/mm3. Because this     study will be carried out over several years, it will provide information on the long-term     advantages and disadvantages of these two treatment strategies.   "
168066|NCT00027365|"     The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are     safe and tolerable in humans and to see how the immune system responds to the vaccines.      There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS     is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to     prevent HIV disease is the best way to try to deal with this situation. Several vaccine     products have been tested, but only 2 are still in trial. There is a need for a new product.   "
168067|NCT00027378|"     This is a large scale study involving fluoxetine (Prozac) versus a placebo in the treatment     of adolescents with alcohol use disorder (AUD) and major depression (MDD). All individuals     will receive treatment for 12 weeks with a followup phase lasting 9 months.   "
168068|NCT00027391|"     This is a study to determine whether albuterol or oxandrolone, alone or in combination, are     able to increase strength and muscle mass in patients with FSHD. It also will determine if     albuterol given in pulsed fashion will have more effect than when given continuously.   "
168069|NCT00027404|"     This is a study to determine the effect of fluoxetine in the treatment of adult autism and on     functional ability and behavior associated with autism. Evidence suggests abnormal serotonin     function in autism. Fluoxetine is a selective inhibitor of the serotonin transporter.   "
168070|NCT00027417|"     This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine     (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease     during cardiopulmonary bypass surgery.   "
168071|NCT00027430|"     This is a study to determine whether testosterone replacement with TheraDerm can improve bone     density, mood, sex drive, thinking, and distribution of body fat and muscle mass in women     with hypopituitarism.   "
168072|NCT00027443|"     This is a study to determine the efficacy of muromonab-CD3 and cyclosporine as treatment in     patients with giant cell myocarditis (GCM). T lymphocytes appear to be involved in GCM.     Muromonab-CD3 has been shown to reduce the number of lymphocytes and cyclosporine inhibits     lymphocyte activation. This treatment may prolong patient survival until transplantation or     ventricular assist device placement is possible.   "
168073|NCT00027456|"     This pilot study will evaluate the safety and effectiveness of leptin therapy in two children     with severe insulin resistance syndrome. Patients with this condition often have high blood     sugar levels and may have hormone imbalances, a constant feeling of warmth, fertility     problems, large appetite, and enlarged liver due to fat accumulation. Leptin is a hormone     produced by fat cells. It influences appetite, affects levels of reproductive hormones, and     possibly manages how the body reacts to insufficient food. Certain people with severe insulin     resistance syndromes have decreased amounts of fat tissue and make little or no leptin.      A 13-year-old male and an 11-year-old female with severe insulin resistance will participate     in this study. They will have the following tests and procedures before beginning 4 months of     leptin therapy:        -  Insulin tolerance test - measures blood sugar levels after intravenous (IV)          administration of insulin. Blood samples are collected through the IV tube at various          intervals during the 1-hour test.        -  Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies.        -  Fasting blood tests - to measure blood count, blood lipids, and various hormones and          assess liver function.        -  Resting metabolic rate - to measure the amount of oxygen breathed at rest in order to          calculate how many calories are required to maintain resting body functions.        -  Magnetic resonance imaging of the liver and other organs, and of muscle and fat.        -  Pelvic ultrasound in female patient - to detect ovarian cysts.        -  Estimation of body fat - measurements of height, weight, waist, hip size, and skin folds          over the arms and abdomen to estimate body fat content.        -  Oral glucose tolerance test - measures blood sugar and insulin levels. The patient          drinks a very sweet drink containing glucose (sugar), after which blood samples are          collected through an IV tube in an arm vein at various intervals during the 3-hour test.        -  Intravenous glucose tolerance test - measures tissue response to insulin and glucose          after glucose injection and insulin infusion. Blood is collected over 3 hours to measure          insulin and glucose levels.        -  Appetite level and food intake - to measure hunger level and caloric intake. Patients          are questioned about their hunger level, given a variety of foods they may choose to eat          and questioned again at various intervals about hunger level. On another day, patients          are given breakfast (usually a milkshake) and when they want to eat again, the appetite          level and caloric intake study is repeated.        -  Hormone function tests - the function of three hormones influenced by leptin          (corticotropin-releasing hormone, thyrotropin-releasing hormone and luteinizing          hormone-releasing hormone) are assessed. The hormones are injected intravenously and          then blood samples are drawn.        -  Questionnaire - patients complete a questionnaire about their activities and how they          feel.        -  24-hour urine collections - to measure specific hormones, proteins and sugars excreted          in the urine.      When the above tests are completed, leptin therapy will start. The drug is injected under the     skin twice a day for 4 months. Patients will record their symptoms weekly throughout the     study. Those with diabetes will measure their blood glucose levels daily before each meal and     at bedtime. Follow-up visits at 1, 2 and 4 months after therapy will include a physical     examination, blood tests and a meeting with a dietitian. At the 4-month visit, the tests done     at the beginning of the study will be repeated.   "
168074|NCT00039273|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have relapsed or refractory metastatic colorectal cancer.   "
168075|NCT00039286|"     RATIONALE: Imaging procedures such as positron emission tomography (PET) may improve the     ability to detect the extent of breast cancer.      PURPOSE: Diagnostic trial to study the effectiveness of PET to detect the extent of breast     cancer in women who have primary or recurrent breast cancer.   "
168076|NCT00039299|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     tumor cells from growing. Treating a person's T cells in the laboratory and then reinfusing     them may cause a stronger immune response and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of T-cell therapy in treating patients who     have prostate cancer that has not responded to hormone therapy.   "
168077|NCT00039312|"     RATIONALE: Screening tests may help doctors detect abnormal cells in the cervix early and     plan effective treatment.      PURPOSE: Screening trial to compare different types of screening tests used to detect     cervical neoplasia.   "
168078|NCT00039325|"     RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's white blood     cells may make the body build an immune response to kill tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy     and to see how well it works in treating patients with stage IV or recurrent malignant     melanoma.   "
168096|NCT00039572|"     RATIONALE: Radiation therapy such as boron neutron capture therapy may kill tumor cells     without harming normal tissue.      PURPOSE: Phase I/II trial to study the effectiveness of boron neutron capture therapy in     treating patients who have glioblastoma multiforme or melanoma metastatic to the brain.   "
168547|NCT00034606|"     The purpose of the study is to measure tumor response rates for three schedules of     Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or     metastatic non small cell lung cancer who have received no prior chemotherapy regimen.   "
168084|NCT00039403|"     Phase I trial to study the effectiveness of combining UCN-01 with gemcitabine in treating     patients who have unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy     use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may     help gemcitabine kill more cancer cells by making tumor cells more sensitive to the drug   "
168085|NCT00039416|"     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have     myelofibrosis. Imatinib mesylate may stop the growth of myelofibrosis by blocking certain     enzymes necessary for cell growth.   "
168086|NCT00039429|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with     locally recurrent or metastatic kidney cancer.   "
168087|NCT00039442|"     Phase II trial to study the effectiveness of capecitabine in treating patients who have     persistent or recurrent cervical cancer. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die.   "
168088|NCT00039455|"     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining trastuzumab with flavopiridol may kill more tumor cells. Phase I trial to     study the effectiveness of combining trastuzumab with flavopiridol in treating patients who     have metastatic breast cancer   "
168089|NCT00039468|"     RATIONALE: Thalidomide may stop the growth of glioblastoma multiforme by stopping blood flow     to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing     so they stop growing or die. Combining thalidomide with irinotecan may kill any tumor cells     remaining after radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan     in treating patients who have glioblastoma multiforme that has been treated with radiation     therapy.   "
168090|NCT00039481|"     Phase I trial to study the effectiveness of oblimersen plus combination chemotherapy and     dexrazoxane in treating children and adolescents who have relapsed or refractory solid     tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and     cyclophosphamide by making the tumor cells more sensitive to the drug. Chemoprotective drugs     such as dexrazoxane may protect normal cells from the side effects of chemotherapy   "
168091|NCT00039494|"     This pilot phase II trial is studying the side effects and best dose of erlotinib when given     with temozolomide and radiation therapy and to see how well they work in treating patients     with glioblastoma multiforme or other brain tumors. Radiation therapy uses high-energy x-rays     to damage tumor cells. Erlotinib may interfere with the growth of tumor cells, slow the     growth of the tumor, and make the tumor cells more sensitive to radiation therapy. Drugs used     in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from     dividing so they stop growing or die. Combining erlotinib and temozolomide with radiation     therapy may kill more tumor cells.   "
168092|NCT00039507|"     RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells.     Combining radiofrequency ablation with surgery may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining radiofrequency ablation with     surgery in treating patients who have stage I or stage II non-small cell lung cancer.   "
168093|NCT00039520|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining sulindac with docetaxel in     treating women who have metastatic or recurrent breast cancer.   "
168094|NCT00039546|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which chemotherapy regimen is more effective in treating women after surgery for     breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel, epirubicin,     and cyclophosphamide with or without gemcitabine in treating women who have undergone surgery     for breast cancer.   "
168097|NCT00039585|"     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes     necessary for cancer cell growth.      PURPOSE: Phase II trial to determine the effectiveness of imatinib mesylate in treating     patients who have refractory or relapsed ovarian epithelial, fallopian tube, or primary     peritoneal cancer, or ovarian low malignant potential tumor.   "
168098|NCT00039611|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Clinical trial to study the effectiveness of combination chemotherapy in treating     patients who have advanced colorectal cancer.   "
168112|NCT00041392|"     The purpose of this study is to examine the effects of supplemental magnesium on the     neurocognitive function of individuals undergoing coronary artery bypass graft (CABG)     surgery.   "
168113|NCT00041405|"     To determine the effect of the method of hyperglycemic management on pro- thrombotic     potential in diabetic subjects.   "
168114|NCT00041418|"     To use magnetic resonance imaging to identify subclinical atherosclerosis and left     ventricular hypertrophy in the Framingham Heart Study cohort.   "
168115|NCT00041431|"     To determine the effects of estrogen therapy on postmenopausal women with congestive heart     failure.   "
168116|NCT00041444|"     To evaluate the relation of retinal microvascular characteristics to subclinical     cardiovascular disease, clinical disease, and their risk factors in the Multi-Ethnic Study of     Atherosclerosis (MESA) cohort.   "
168117|NCT00041457|"     To evaluate potentially modifiable lifestyle predictors of venous thromboembolism and their     joint associations with biochemical and genetic determinants.   "
168118|NCT00041470|"     The purposes of this are:        -  To determine the highest doses of Taxol and Navelbine that we can safely give to          patients;        -  To determine what kind of side effects are caused by the combination of Taxol, Navelbine          and G-CSF;        -  To determine whether the combination of Taxol, Navelbine and G-CSF is more effective          than standard therapy in treating metastatic breast cancer and prolonging life;   "
168099|NCT00039624|"     This study will evaluate the use of magnetic resonance imaging (MRI) for guiding placement of     hollow needles into the prostate gland for delivering internal radiation therapy to patients     with prostate cancer. Prostate cancer is often treated with a combination of external beam     radiation therapy and brachytherapy (internal radiation delivered close to the tumor). This     study will determine whether MRI is more accurate in guiding needle placement than     ultrasound, which is currently used for this purpose. Patients will have one brachytherapy     treatment followed by 5 weeks of external beam treatments and a second brachytherapy.      Patients 18 years of age and older with prostate cancer that has not spread to the bone may     be eligible for this study. Candidates will be screened with a physical examination, blood     and urine tests, and a bone scan.      To plan for radiation therapy, patients will have standard computed tomography (CT) and MRI     scans of the pelvis and prostate. In addition, CT and MRI scans will be done to determine if     the prostate is in a good position for brachytherapy. For these scans, patients will have an     enema and a tube will be placed in the rectum. They will then lie still on their side for     about 45 minutes during the scan. Patients who have blood in their urine will also undergo     cystoscopy. This is an examination of the bladder using a small camera that is advanced     through the penis into the bladder.      Patients are given an antibiotic for 2 days before the brachytherapy and on the morning of     the procedure. Before the test, they have a small enema and are given medicines through the     vein and into the spine for relaxation and to decrease any discomfort. (The test is done     under general anesthesia for patients who require it.) The patient is moved on a stretcher     into the MRI scanner and a catheter is inserted into the bladder through the penis. The     bladder is filled with water and a tube is placed in the rectum. With the help of a plastic     guide placed against the skin, about 14 to 18 needles are then placed in the prostate. Some     stitches are sewn to hold the needles and the guide in place, and the tube in the rectum is     removed. The patient is the transferred from the MR scanner into the CT scanner, where the     rectal tube is reinserted and the needles are adjusted. A cystoscopy is done to make sure the     needles do not enter the bladder. When the needles are adjusted, the tube is removed from the     rectum and the patient is moved to the radiation oncology clinic.      After a few hours, when the radiation dose has been calculated, a radioactive substance     called iridium is administered. The needles placed in the prostate are connected to a     radiation machine, and thin wires with radioactive material on the tips are inserted into     each needle and withdrawn a little at a time. The process takes about 20 to 30 minutes. The     patient is then disconnected from the machine and undergoes another MRI scan to confirm the     position of the needles. The needles and catheter are then removed and the patient is     monitored for a while before going home. Patients then have 5 weeks of external beam therapy,     followed by a second brachytherapy treatment.      Patients return to the clinic at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after treatment     for blood tests, physical examination, and review of symptoms.   "
168100|NCT00041223|"     RATIONALE: IH636 grape seed extract may lessen hardening of breast tissue caused by radiation     therapy and may help patients live more comfortably.      PURPOSE: Randomized phase II trial to study the effectiveness of IH636 grape seed extract in     treating hardening of breast tissue in women who have undergone radiation therapy for early     breast cancer.   "
168101|NCT00041236|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients     who have advanced soft tissue sarcoma.   "
168102|NCT00041249|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of brostallicin in treating patients who     have locally advanced or metastatic soft tissue sarcoma that has not responded to one     previous chemotherapy regimen.   "
168103|NCT00041262|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which regimen of combination chemotherapy is more effective in treating esophageal     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of     combination chemotherapy in treating patients who are undergoing surgery for esophageal     cancer.   "
168104|NCT00041275|"     RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using megestrol     may fight liver cancer by blocking the uptake of estrogen. It is not yet known if megestrol     is an effective treatment for liver cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in treating     patients who have liver cancer that cannot be removed by surgery.   "
168105|NCT00041288|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Peripheral stem cell transplantation may be able to replace immune cells that were destroyed     by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the     body's normal tissues. Cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus may     prevent this from happening.      PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine plus     total-body irradiation with that of combination chemotherapy followed by donor peripheral     stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma or     chronic lymphocytic leukemia.   "
168106|NCT00041301|"     RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may     help determine the intermediate and long-term effects of the treatment on these patients.      PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality     of life of patients who have prostate cancer.   "
168107|NCT00041314|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind     in treating patients who have advanced non-small cell lung cancer.   "
168108|NCT00041327|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Antiviral therapy may kill viruses such as HTLV-1 that can cause     cancer. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy     with antiviral drugs and interferon alfa may be effective in treating adult T-cell     leukemia/lymphoma.      PURPOSE: Phase II trial to determine the effectiveness of combination chemotherapy followed     by antiviral therapy and interferon alfa in treating patients who have adult T-cell     leukemia/lymphoma caused by HTLV-1.   "
168109|NCT00041340|"     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have     stage IV colorectal cancer. Imatinib mesylate may interfere with the growth of tumor cells by     blocking certain enzymes necessary for cancer cell growth   "
168131|NCT00041652|"     The purpose of this trial is to determine the safety of hMN14 at different dose levels in the     treatment of either colorectal or breast cancer.   "
168110|NCT00041353|"     RATIONALE: Examining biomarkers in fine-needle aspiration specimens from women at risk for     breast cancer may improve the ability to detect breast cancer cells early and plan effective     treatment.      PURPOSE: Screening trial to compare specific biomarkers based on fine-needle aspiration     specimens from women at increased or normal risk of breast cancer.   "
168111|NCT00041379|"     RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the     immune system and stop cancer cells from growing.      PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients     who have Waldenstrom's macroglobulinemia.   "
188586|NCT00319930|"     The purpose of the study is to evaluate the effects of increasing doses of CNF1010 on     pharmacodynamic markers and hematological response.   "
168119|NCT00041483|"     The purpose of this study is to demonstrate that Anecortave Acetate is as effective after     twelve months of treatment as photodynamic therapy (PDT) with Visudyne in patients eligible     for initial PDT treatment for wet age-related macular degeneration.   "
168120|NCT00041496|"     The purpose of this study is to determine whether the study drug is effective in preventing     the recurrence of atrial fibrillation (an abnormal heart rhythm).   "
168121|NCT00041509|"     The purpose of this study is to gain additional safety information as well as to determine     after the study drug has been given to patients who have undergone total hip replacement     surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood     clots in legs) or pulmonary embolism (blood clots in lungs).   "
168122|NCT00041535|"     Gaucher disease is an inherited functional deficiency of glucocerebrosidase. This enzyme     breaks down a fatty substance (lipid) called glucocerebroside, which is present in all cells     of the body. When cells renew themselves, the lipids must be broken down and discarded.     Because the enzyme does not function well, the lipid builds up in certain tissues, such as     the liver and spleen. The nervous system is involved as well; memory is impaired and it is     difficult to move the eyes from side to side. It has been shown that repeated infusions of     glucocerebrosidase help break down the stored lipid. However, this treatment does not improve     any neurological symptoms.      A medicine called OGT 918 has been shown to slow the production of the lipid that builds up     in Gaucher disease. It also has been shown to enter the brain. It is hoped that taking OGT     918 will reduce the storage of glycolipids in cells and improve the neurological symptoms of     the disease. This clinical trial seeks to evaluate OGT 918 as a treatment for neuronopathic     Gaucher disease by assessing changes in eye movement velocity. A secondary goal is to assess     the clinical safety and tolerability of OGT 918 therapy.      Up to 30 patients from the National Institutes of Health and the Institute of Child Health     (London) will be randomly assigned to OGT 918 or no treatment for 12 months. Study     participants must be clinically diagnosed with neuronopathic Gaucher disease, 12 years of age     or older, and able to swallow capsules. They must have been stable on ERT for at least 6     months before the study.      Patients receiving OGT 918 will receive a dose of 200 mg OGT 918 three times daily. Data     analysis will be done after 12 months. The study will be extended up to 12 months to collect     safety and efficacy data. All patients who complete the main study and enter the extension     study will receive OGT 918.      During a 4-week screening period, eye movement velocity will be measured. These assessments     will be repeated at months 12 and 24. Also at screening and months 12 and 24, the following     tests will be done: MRI/CT, to measure spleen and liver volume; pulmonary imaging (by X-ray)     and function tests; nerve conduction velocity studies and neuropsychological assessments;     evoked response studies (to measure how the brain conducts electrical messages); and tremor     measurements. Additional assessments for tremor will be conducted at months 6 and 18.      Plasma samples will be obtained every 3 months to measure disease markers and safety     profiles. Proteasome samples will be taken at screening and month 6 to identify proteins that     may be associated with Gaucher disease. Blood will be obtained at month 1 from the first 6     consenting patients who have been randomly assigned to take OGT 918. These patients will also     have a cerebrospinal fluid sample taken by lumbar puncture at month 1. These samples will be     measured for how much OGT 918 is present.      All patients receiving OGT 918 will have an initial assessment 1 week after beginning     treatment to evaluate tolerance of the therapy. Clinic visits will be every 3 months. All     patients will be asked to keep a simple diary of adverse events and dietary information. Dose     levels may be reduced if a patient experiences severe gastrointestinal problems.   "
168123|NCT00041548|"     The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas     by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen),     within one hour of initiation and with no significant adverse effects.   "
168124|NCT00041561|"     The purpose of this study is to determine the effect of nitric oxide for inhalation on the     duration of mechanical ventilation in pediatric patients with AHRF.   "
168125|NCT00041574|"     The purpose of this program is to evaluate the logistic issues and patient requirements for     chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient     needs, patients with a variety of underlying diseases will be included. Safety of chronic     therapy will be monitored by serial measurements of methemoglobin, platelet function assay     and reported adverse events.   "
168126|NCT00041587|"     IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a     bacteria toxin). IL13-PE38QQR is a protein that exhibits cell killing activity against a     variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic     benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the     IL13 receptors was shown to be highly specific for human glioma cells.      Prior to treatment, patients will have physical and neurologic exams, MRI to measure the     extent of tumor, tumor biopsy, and screening laboratory tests. On Day 1, one or two catheters     will be inserted directly into the tumor, after which a CT scan will be used to confirm     placement. Each patient will receive one IL13-PE38QQR infusion, and the tumor will be     surgically removed on approximately Day 15. In the first group of patients, IL13-PE38QQR will     be infused directly into the tumor for 4 days. Depending on effectiveness or side effects of     the study drug, the duration will be increased stepwise to a maximum of 7 days in subsequent     groups of patients. Once duration of infusion has been determined, the dose of IL13-PE38QQR     will be increased stepwise (in separate groups of patients), depending on effectiveness or     side effects of the study drug. The activity of the drug against the tumor cells will be     judged by examining the removed tumor tissue. Patients will have neurologic exams and MRI     scans immediately after the resection and every eight weeks until disease progression is     observed.   "
168127|NCT00041600|"     The purpose of this study is to identify genes responsible for epilepsy and disorders of     human cognition.   "
168128|NCT00041613|"     There is a need for more treatment options for patients with recurrent squamous cell cancer     of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that     include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the     development of tumors. In this study the transfer of the p53 gene to tumor cells using a     modified adenovirus (INGN 201) will be compared to methotrexate in patients who have failed     surgery, radiotherapy and chemotherapy with platinum or taxanes.   "
168129|NCT00041626|"     There is a need for more treatment options for patients with recurrent squamous cell cancer     of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that     include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the     development of tumors. In this study the transfer of the p53 gene to tumor cells using a     modified adenovirus (INGN 201) in combination with chemotherapy (cisplatin and fluorouracil)     will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed     surgery and radiotherapy.   "
168130|NCT00041639|"     The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in     the treatment of pancreatic cancer.   "
168132|NCT00041665|"     Radiotherapy and high dose chemotherapy with bone marrow transplantation or peripheral blood     stem cell transplantation is frequently used as treatment for patients with cancers of the     bone marrow or lymph nodes such as Hodgkin's disease, non-Hodgkin's lymphoma, leukemia or     multiple myeloma. A common side effect of the radiotherapy and high dose chemotherapy is     mucositis (inflammation of the inside of the mouth and throat resulting in pain and     difficulty swallowing). Mucositis is often very severe such that patients receive intravenous     nutrition and pain medication in the hospital.      In this study, an investigational recombinant human growth factor called Keratinocyte Growth     Factor (rHuKGF) is being evaluated to determine its protective effect on the mucosal tissue     and its ability to reduce the mouth and throat soreness.   "
168133|NCT00041678|"     The purpose of this study is to learn if aripiprazole is safe and effective in the treatment     of psychosis associated with dementia of the Alzheimer's type.   "
168134|NCT00041691|"     The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in     the treatment of residual colorectal cancer following recent surgery.   "
168135|NCT00041704|"     Anidulafungin is an antifungal agent of the echinocandin class which is highly active in     vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has     demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as,     in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC     an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety     are inadequate in the treatment of this disease.   "
168190|NCT00042445|"     The aim of this study is to examine the association of exposure to air contaminants (PAH &     VOC) emitted from the petrochemical industries, specific genetic polymorphisms (P4501A1 (MspI     & exon 7) and GSTM1 & T1) of study subjects and their parents, and the risks of brain tumors     and leukemia among children and youths in metropolitan Kaohsiung, southern Taiwan.   "
168442|NCT00033020|"     The purpose of this study is to test the utilization of incentive values (considerably lower     than those typically used in research clinics) to motivate clients to attend treatment and     initiate and sustain abstinence.   "
168136|NCT00041717|"     Normally, nerve fibers carry electrical impulses through the spinal cord, providing     communication between the brain and the arms and legs. In people with spinal cord injury,     some fibers may be destroyed at the site of injury, while others remain connected but do not     work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal     cord injury may have spasticity which is muscle spasms or muscle stiffness that makes     movement difficult. Fampridine-SR is an experimental drug that increases the ability of the     nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on     moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as     bladder control, bowel function and sexual function. The study will also examine the possible     risks of taking Fampridine-SR.   "
168137|NCT00041730|"     The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus     FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their     idiotype.   "
168138|NCT00041743|"     This is a study examining the use of different degrees of therapist involvement in the     treatment of Binge Eating Disorder. The study will examine both which approaches work best     for decreasing symptoms and which are most cost-effective.   "
168139|NCT00041756|"     Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742     inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This     study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate     knee osteoarthritis.   "
168140|NCT00041769|"     Drug resistance testing can be used to see which anti-HIV drugs are likely to suppress the     growth of HIV and to select an anti-HIV regimen for HIV infected patients who have failed     previous drug regimens. Therapeutic drug monitoring (TDM) is a process that involves     measuring blood levels of a drug and may further increase the benefits that resistance     testing offers by optimizing protease inhibitor (PI) drug concentrations. The purpose of this     study is to determine whether changing the dose of PIs, as indicated by TDM, reduces the     viral load in PI-experienced patients.      Hypothesis: Treatment-naive study participants who undergo TDM and whose clinicians'     interpret their TDM results and adjust their PI doses will have better virologic response     rates and decreased toxicities (and thus better treatment outcomes) than participants who do     not undergo TDM.   "
168141|NCT00041782|"     Study Plan: Adult cancer patients who have a low risk profile and present with DVT will     receive dalteparin 200 IU/kg subcutaneously daily (based on actual body weight with a maximum     dose of 18,000 IU). Eligible patients who have signed the informed consent will be instructed     on injection technique, will give themselves their first subcutaneous injection under     supervision of the physician or the nurse and will be observed for a minimum of 1-2 hours     prior to discharge. Patients may be admitted to an observation unit for up to 24 hours prior     to discharge if medically necessary. Those patients without complications during the     observation period will be given discharge instructions and an outpatient schedule to see one     of the physician investigators daily for their subcutaneous injection of dalteparin, routine     lab work and initiation of oral anticoagulation therapy.      Patients that are proficient in administering their own injection with dalteparin will be     evaluated every other day by the physician investigator. On days of home injection, the study     nurse will call the patient to check on the patient's status and to remind the patient of     his/her daily injection. Patients will undergo a physical examination every other day by the     physician investigator directed towards the clinically affected areas until a therapeutic     response (INR 2-3) on oral warfarin has been achieved or the patient's clinical condition     warrants modification of therapy with or without hospitalization. Patients will remain on     study for a minimum of 5 days with at least 1 day of therapeutic oral anticoagulation.      The quality of life of the patients enrolled will be assessed by using the Modified Medical     Outcome Study Short Form-20. An adapted version of the Rotterdam Symptom Checklist will be     used to specifically assess patients with thrombosis. Patients will complete these two     instruments at study entry, day 3, day 5 and at the end of study if different from day 5.   "
168142|NCT00041795|"     This study will assess the safety and efficacy of Neotrofin in treating the peripheral     neuropathy that results from chemotherapy for cancer.   "
168143|NCT00041808|"     MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to “stick”, to     magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is     added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and     deposited in the area of a tumor, where it is thought that it then leaks through the blood     vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes free     from the magnetic beads and will then be able to act against the tumor cells. The iron     component of the particle has magnetic properties, making it possible to direct MTC-DOX to     specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that     MTC-DOX used with the magnet may target the chemotherapy drug directly to liver tumors and     provide a treatment to patients with cancers that have spread to the liver.   "
168144|NCT00041821|"     This study seeks to document differences in nasal irritant sensitivity within the population.     The investigators are interested in knowing whether age, gender, and allergy status (nasal     allergies) predict nasal irritant sensitivity. This is important in understanding symptom     reporting patterns in air pollution situations (particularly in so-called problem     buildings), as well as in understanding the reflex mechanism of a response of the nose to     irritants (e.g., nasal congestion).   "
168145|NCT00041834|"     This study surveys the parents/guardians about symptoms and diagnosis of asthma in     kindergarten and first-grade students in 13 schools around the city of Anchorage, Alaska.     Traffic information is also measured and entered in geographical information mapping system     with student's home and school locations. The study will assess whether students living in     high traffic areas have greater risk of diagnosis of asthma.   "
168146|NCT00041847|"     The purpose of this study is to determine whether certain environmental factors, namely     occupational exposures and diet, have a greater effect on prostate cancer risk in the     presence of selected inherited genetic factors.   "
168147|NCT00041860|"     The research is to evaluate benzene metabolism after exposure at levels that can be found in     the environment, such as the higher end concentrations in the air inside cars and buses while     being driven in heavy traffic and inside private and public parking garages. To do so breath,     urine, and blood samples prior to, during and after being exposed to benzene as well as     benzene levels and benzene metabolites present are measured.   "
168191|NCT00042458|"     This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the     safety of pramlintide treatment using pramlintide dose-titration coupled with insulin     adjustments in subjects with type 1 diabetes who are actively trying to improve their     glycemic control.   "
168192|NCT00042471|"     This is a randomized, open-label, crossover study to examine the bioavailability of     pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus     using insulin.   "
168148|NCT00041886|"     Radiofrequency ablation is used to treat patients with many different conditions. It is used     to treat heart arrhythmia and benign bone tumors, and to control bleeding during surgery. It     has been approved by the Food and Drug Administration for soft tissue ablation (removal). The     technique involves inserting a probe, guided by computed tomography or ultrasound, and     sending radio waves through the probe. The radio waves generate heat, which both destroys     adjacent tissue and cauterizes blood vessels.      This study will enroll 15 adults (age 18 or older) with soft tissue metastases who suffer     pain that is not well controlled by other means, such as drugs. The goal is to reduce their     pain or their use of analgesics by partially destroying some of their tumors.      Patients will be ineligible for the study if they change the class of pain medication they     use within 2 weeks before or 2 weeks after the study treatment. Patients will fill out short     questionnaires about pain and daily activities (Brief Pain Inventory) before treatment and 1     day, 1 week, 1 month, 3 months, and 12 months after treatment to ascertain whether their pain     is better controlled with less pain medication.      For the treatment, most patients will receive local anesthetic in the area where the probe is     inserted. Some patients may require general anesthesia. The probe will remain in place     typically for 10 to 30 minutes. For larger tumors, it may be inserted at different positions.   "
168149|NCT00041899|"     This study will compare blood levels of the drug CDB-2914 in healthy women receiving the     compound in crystalline powder form with the blood levels of women receiving an identical     dose of the drug in micronized form. Generally, absorption of compounds made into a     crystalline powder is less than that of micronized compounds, in which the substance is     processed into many similar-sized particles.      CDB-2914 is a manmade hormone similar to the hormones cortisol and progesterone. The National     Institute of Child Health and Human Development is evaluating the ability of this drug to     treat reproductive conditions. Institute studies have shown that CDB-2914 can increase the     time to produce a mature egg in the ovary, and cause an early menstrual period, CDB-2914     might be used to treat fibroids and endometriosis pain. As part of its evaluation for these     purposes, this study will determine if absorption of crystalline and micronized powder forms     of CDB-2914 result in the same blood levels of the drug.      Women between 18 and 50 years of age who are in good health may be eligible for this study.     Premenopausal women must not be pregnant (as determined by a urine pregnancy test) or     breastfeeding and must practice birth control during the study. Candidates will be screened     with a medical history, physical examination, and blood and urine tests. Women who use an IUD     for contraception are advised to also use a barrier contraceptive (diaphragm or condom) the     week after taking CDB-2914.      Participants will be admitted to the NIH Clinical Center inpatient service or the outpatient     day hospital twice for pharmacokinetic studies (blood drawing to measure blood levels of     CDB-2914 after a single dose of the drug). They will come to the Clinical Center at 7:00 a.m.     and have a catheter (thin plastic tube) inserted into an arm vein for drawing blood for the     first 24 hours of the study. Eight milliliters (about 2 teaspoons) of blood will be drawn 5     minutes and 1 minute before taking CDB-2914 (in either crystalline or micronized powder form)     and then at the following times after taking the drug: 15, 30, 45, 60, 75, 90, 105, 120, 150     and 180 minutes (3 hours), and 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hours (5 days).      Participants will take all their meals in the day hospital or ward during the first 26 hours     of sampling. Inpatients will leave the hospital after the 24-hour blood draw and return as an     outpatient on days 2 through 5. At the 48-hour time point, additional blood will be drawn to     check blood counts and chemistries, and for liver and kidney function tests.   "
168150|NCT00041925|"     The purpose of this study is to determine the efficacy of graft pretreatment with the E2F     decoy, CGT003, as compared to placebo, on the occurrence of graft failure among patients who     receive autogenous vein grafts to treat chronic critical limb ischemia; on the occurrence of     clinically significant graft stenosis (more than or equal to 70%); and on the incidence of     critical limb ischemia (e.g., gangrene, non-healing ischemic ulcers or ischemic rest pain).   "
168151|NCT00041938|"     The purpose of this study is to determine which of two treatments, Warfarin or aspirin, is     better for preventing death and stroke in patients with poor heart function.      We are now transitioning into the sub-analysis part of the WARCEF patient data.      The study has recently completed data analysis for its Primary Aim. All randomized patients     have completed their follow up. All study related procedure as per the protocol has been     completed. We are now in the extension phase of the study to obtain more patient data to     address further aims of the study. No new procedures are performed and data already in place     at the sites will be collected (EKG and echocardiograms).      The aims for this study extension are:        -  To assess progression of cardiac dysfunction over time among heart failure patients        -  To correlate prognosis with cardiac dysfunction   "
168152|NCT00041951|"     The purpose of our study is to identify gene(s) involved in the cause of childhood absence     epilepsy (CAE).   "
168153|NCT00041964|"     The purpose of this study is to find out if HIV-infected pregnant women taking anti-HIV drugs     have an increased amount of HIV in their blood (viral load) after having the baby.      The purpose of A5153s, a substudy of A5150, is to characterize two anti-HIV drugs (nelfinavir     [NFV] and lopinavir/ritonavir [LPV/r]) in HIV-infected women during pregnancy and after     childbirth.      Sometimes pregnant women have an increase in their HIV viral load after their baby is born.     This study will try to find out how often this happens. It will also examine possible reasons     why the increase in viral load occurs.   "
168154|NCT00041977|"     The purpose of this study is to determine whether Periostat(R), Doxycycline Hyclate 20 mg     Tablets, taken twice daily is effective in reducing the red and white heads and overall     redness associated with rosacea.   "
168155|NCT00041990|"     To determine the safety and efficacy of decitabine in patients with Philadelphia     chromosome-positive chronic myelogenous leukemia accelerated phase that were previously     treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be     intolerant to the drug.   "
168156|NCT00042003|"     To determine the safety and efficacy of decitabine in patients with Philadelphia     chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated     with imatinib mesylate (STI 571) and became resistant/refractory or were found to be     intolerant to the drug.   "
168157|NCT00042016|"     To determine the safety and efficacy of decitabine in patients with Philadelphia     chromosome-positive chronic myelogenous leukemia chronic phase that were previously treated     with imatinib mesylate (STI 571) and became resistant/refractory or were found to be     intolerant to the drug.   "
168158|NCT00042029|"     A clinical study to determine the efficacy and safety of MK0869 in the treatment of     depression.   "
168193|NCT00042484|"     The Community Organizing Network for Environmental Health is a part of Community Action     Against Asthma (CAAA), which, in turn is a part of the Michigan Center for the Environment     and Children's Health. It is a community-based intervention research partnership between the     University of Michigan, community-based organizations, and health care institutions in     Detroit.   "
168194|NCT00042497|"     The objective is to determine the safety and efficacy of dexosome immunotherapy in patients     with Stage IV malignant melanoma   "
168159|NCT00042042|"     The purpose of this study is to evaluate the prevalence of Type 2 diabetes or impaired     glucose tolerance in a subset of children 10-19 years of age in an inner city community     clinic. The demographics of the clinic are 75% African American, 20% Hispanic, 5% other.     African American and Hispanic patients have a higher prevalence of diabetes with significant     morbidity, predominantly from microvascular and macrovascular disease. Obesity is commonly     seen in patients with Type 2 diabetes and contributes to the underlying insulin resistance     seen in the disease. Obesity is an increasing health problem among adolescents. Since Type 2     diabetes can be present for several years before diagnosis, it is worrisome that younger     children will have undiagnosed Type 2 diabetes for years. This will increase the risk of     earlier complications in these patients as young adults.      We hypothesize that the occurrence of abnormal glucose metabolism in 400 children with either     a history of obesity, family history of diabetes mellitus, or symptoms suggestive of diabetes     mellitus will be higher than the general pediatric population. We believe that a family based     educational program can reduce fasting plasma glucose.   "
168160|NCT00042055|"     Patients with moderately to severely active Crohn's disease will be treated with oral CP-461     200 mg (2 x 100 mg capsules) twice-daily for 8 weeks.      The purpose of this study is to see if CP-461 improves the symptoms of Crohn's disease and/or     the patient's quality of life. Patient's safety will be monitored throughout the study.   "
168161|NCT00042068|"     A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective     and safe three different doses of meloxicam are compared with placebo in Rheumatoid     Arthritis. Patient will take one dose of study medication daily.   "
168162|NCT00042081|"     The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 (E2F     Duplex Decoy), as compared to placebo, on the incidence of patients experiencing vein graft     failure after coronary artery bypass surgery.   "
168163|NCT00042094|"     This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured     vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will     be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a     blinded fashion. Subjects will be followed closely for up to 6 months and a subgroup of     volunteers will be followed up to 3 years in order to evaluate the duration of immunity     following vaccination. Another cohort will enroll 100 vaccinia-experienced volunteers and     randomly assign them to receive either CCSV (50 volunteers) or Dryvax® (50 volunteers) and a     sub group will be followed up to 3 years. A fifth cohort will enroll 100 vaccinia-naive     volunteers and randomly assign them to receive different dilutions of CCSV (1:1, 1:5, 1:25,     and 1:50).   "
168164|NCT00042107|"     The aim of this research is to discover genes which modify risk for Parkinson's disease. The     study includes 800 patients with Parkinson's disease, and their estimated 1,222 available     siblings. Common variations of at least 9 genes will be studied, including genes associated     with personality, substance use, and anxiety and depression.   "
168165|NCT00042120|"     The long term goal of this research is to elucidate the cause(s) of Parkinson's disease, with     a focus on environmental determinants. We propose to investigate the relationship between     Parkinson's disease and exposure to pesticides and other factors by conducting a nested     case-control study in the Agricultural Health Study.   "
168166|NCT00042133|"     The overall goal of the proposed project is to examine the reasons for the higher levels of     disability in older people of lower socio-economic status.   "
168167|NCT00042146|"     This study will evaluate the long- and short-term effects of cognitive-behavior therapy     (CBT), alone and in combination with zolpidem (Ambien®), for chronic insomnia.   "
168168|NCT00042159|"     This study will evaluate the long-term effects of repetitive transcranial magnetic     stimulation (rTMS) in patients with auditory hallucinations.   "
168169|NCT00042172|"     The purpose of this study is to evaluate the effectiveness of donepezil (Aricept) for the     treatment of mild cognitive impairment (MCI) in elderly adults. This study will also     determine whether adding ginkgo biloba extract (GBE) enhances the effects of donepezil.   "
168170|NCT00042185|"     This study evaluated 2 eating disorder prevention programs designed to increase body     satisfaction among adolescent females with body image concerns.   "
168171|NCT00042198|"     This randomized controlled trial will test the efficacy of (1) cognitive behavior therapy and     (2) supportive stress management as treatments for depression in people who have recently     undergone coronary artery bypass graft surgery.   "
168172|NCT00042211|"     This study will evaluate the effectiveness of a Problem Solving Treatment in preventing     depression in elderly patients with age-related macular degeneration (AMD).   "
168173|NCT00042224|"     This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded     adequately to clozapine.   "
168174|NCT00042237|"     The purpose of this study is to compare Schema-Focused Therapy plus antidepressant medication     and antidepressant medication alone for the treatment of major depression in women with a     history of childhood sexual abuse.   "
168175|NCT00042250|"     To determine cell cycle parameters and changes after treatment, the labelling agent is given     and a bone marrow aspiration is accomplished before treatment and after treatment for     comparison. Participants must be undergoing concurrent therapy for hematologic malignancy.   "
168188|NCT00042419|"     This is a study of the effects of fast paced assembly line work on women. We are studying     problems women in poultry processing have with their muscles, tendons, and nerves as well as     acute injuries they have in the workplace. We are also studying how their work affects the     quality of their lives.   "
168189|NCT00042432|"     This study will assess an investigational medication for patients with chronic renal     insufficiency (pre-dialysis) who have secondary hyperparathyroidism.   "
168548|NCT00034619|"     The purpose of this study is to assess the antitumor activity of ALIMTA plus Oxaliplatin     combination therapy in patients with previously untreated advanced colorectal cancer   "
168195|NCT00042510|"     This study will test whether the G17DT Immunogen, when administered in combination with     chemotherapy, is an effective and safe treatment for gastric cancer.   "
168443|NCT00033033|"     The purpose of this study is to assess the efficacy and safety of reserpine for the treatment     of cocaine dependence.   "
168176|NCT00042263|"     The Healthy Environments Partnership was established in October 2000, as a part of the     National Institute of Environmental Health Sciences “Health Disparities Initiative.” The     Healthy Environments Partnership seeks to expand the knowledge base of how social and     economic inequalities are linked to disparities in cardiovascular health among residents of     Detroit. The Healthy Environments Partnership is a project of the Detroit Community-Academic     Urban Research Center. The partners are: Brightmoor Community Center, Butzel Family Center,     the Detroit Health Department, Friends of Parkside, Henry Ford Health System, Southwest     Counseling and Development Services, Southwest Detroit Environmental Vision and University of     Detroit Mercy and the University of Michigan School of Public Health, School of Nursing, and     the Institute for Social Research.   "
168177|NCT00042276|"     This study will use microdialysis to investigate myofascial pain. This pain is characterized     by trigger points (exquisitely tender spots) in a group of tense muscle fibers that extend     from the trigger point to the muscle attachments. Trigger points in the trapezius, a large     muscle lying between the neck and shoulder, are typically caused by emotional stress,     postures such as hunching shoulders, certain activities like using a telephone receiver     without elbow support, or by wearing certain articles such as a heavy coat or heavy purse.     Microdialysis uses a very thin needle probe (about the size and shape of an acupuncture     needle) to collect and measure chemicals directly from soft tissue. Analysis of these     chemicals will show whether changes in the tissue around a muscle with trigger points are     confined to that muscle, or if these changes also occur in more distant muscles.      The study will examine two types of trigger points. An active trigger point causes pain or     other abnormal symptoms and often causes problems with movement. A latent trigger point     often causes movement problems without causing pain. Many healthy adults have latent trigger     points.      People between 21 and 65 years of age with the following characteristics may be eligible for     this study: 1) no neck pain or trigger points in either upper trapezius muscle; 2) no neck     pain but a latent trigger point in at least one upper trapezius muscle; or 3) neck pain of     less than 3 months' duration and an active trigger point in at least one upper trapezius     muscle. Participants undergo the following procedures:        -  Physical examination of the muscles of the neck and shoulder area, testing strength and          range of motion, and response to palpation to find trigger points.        -  Pain inventory. Subjects complete a questionnaire for measuring pain and its intensity,          location, quality, causes, relievers, and associated symptoms. The questionnaire is          filled in before and after each microdialysis procedure.        -  Microdialysis in upper trapezius muscle. An electrode patch is placed on either side of          the site for insertion of the microdialysis probe and another electrode is placed on the          outer edge of the shoulder. The electrodes are used to measure any electrical activity          that occurs with insertion or movement of the probe. The subject lies face down and the          probe is inserted in the upper trapezius muscle. It remains in place for 5 minutes while          chemical substances are collected from the muscle. It is then advanced about 1.5 cm          deeper into the muscle until a twitch response is obtained and remains in place for 10          more minutes while substances are collected.        -  Microdialysis in the gastrocnemius muscle (large muscle of the calf). The same procedure          for the upper trapezius muscle is done in the calf muscle.   "
168178|NCT00042289|"     The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV)     and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are     the various interactions between a drug and the body.) This study will also evaluate the PKs     of certain ARVs in postpartum women before and after starting hormonal contraceptives. The     PKs of these drugs will be evaluated by measuring the amount of medicine present in blood     and/or vaginal secretions.   "
168179|NCT00042302|"     To determine whether tariquidar + combined first-line chemotherapy of paclitaxel/carboplatin     in patients with Stage IIIb/IV NSCLC will, with an acceptable safety profile, significantly     improve overall survival compared with placebo + paclitaxel/carboplatin. To compare the     effects of tariquidar/paclitaxel/carboplatin with placebo/paclitaxel/carboplatin on tumor     response, time to disease progression, performance status, symptom progression, and quality     of life in patients with Stage IIIb/IV NSCLC.   "
168180|NCT00042315|"     To determine whether tariquidar + first-line single agent vinorelbine chemotherapy in     patients with Stage IIIb/IV NSCLC will, with an acceptable safety profile, significantly     improve overall survival compared with placebo + vinorelbine. To compare the effects of     tariquidar/vinorelbine with placebo/vinorelbine on tumor response, time to disease     progression, performance status, symptom progression, and quality of life in patients with     Stage IIIb/IV NSCLC.   "
168181|NCT00042328|"     The purpose of this research is to study the pharmacology (how the body handles this drug) of     valacyclovir in children receiving treatment for cancer. This study will last approximately 7     days.   "
168182|NCT00042341|"     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia     (ALL) who have had at least 2 prior treatment regimens.      The purpose of this study is to determine whether Clofarabine is safe and effective in the     treatment of Acute Lymphoblastic Leukemia (ALL.)   "
168183|NCT00042354|"     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia     (ALL) who have had at least 2 prior treatment regimens.      The purpose of this study is to determine whether Clofarabine is safe and effective in the     treatment of Acute Myelogenous Leukemia (AML.)   "
168184|NCT00042367|"     The purposes of this study are to find the highest dose of mafosfamide that can be given     without causing severe side effects, to see how well the combination of these chemotherapy     drugs and lower doses of radiation work to delay or stop the growth of the tumor, and to     evaluate the pharmacokinetics (how the body handles) of Mafosfamide.   "
168185|NCT00042380|"     The purpose of this study is to find out if the soy-based dietary supplement Novasoy     (Registered Trademark) is effective for the short-term treatment of clinical depression. This     study will also evaluate whether Novasoy (Registered Trademark) is effective in treating the     anxiety that often accompanies depression and will assess the best dose level.      Novasoy (Registered Trademark) is a marketed botanical dietary supplement containing soy     isoflavones. The active form of the soy isoflavone genistin may be a novel treatment for     neuropsychiatric illnesses. The soy isoflavone's specific hormonal properties may also have     beneficial effects on brain function in depressed patients.      This study will be conducted in two phases. During Phase I, participants will stop all     medications for at least 1 week. A psychiatric and medical examination will be conducted.     During Phase II, participants will be randomly assigned to receive either Novasoy (Registered     Trademark) or a placebo (an inactive pill) for 8 weeks. Participants who do not respond to     treatment after 5 weeks will be given a higher dose of their assigned medication. After the     8-week period, participants will be monitored for up to 3 months before being referred back     to their clinician for further treatment.   "
168186|NCT00042393|"     The purpose of this early access protocol is to provide access to adefovir dipivoxil prior to     its commercial availability to people with lamivudine-resistant chronic hepatitis B who have     limited treatment options.   "
168187|NCT00042406|"     The purpose of this study is to determine whether HuMax-CD4 is effective in the treatment of     active rheumatoid arthritis in patients who have failed treatment with Methotrexate and at     least one TNF-alpha blocking agent.   "
168196|NCT00042523|"     This study will examine the possible relationship between certain antibodies found in     patients with systemic lupus erythematosus (SLE) and cognitive (thought processing)     impairment in these patients. Antibodies are proteins produced by cells of the immune system     to fight foreign invaders such as bacteria and viruses. In autoimmune diseases like SLE,     however, the immune system produces antibodies against the body's own healthy tissues.     Antibodies targeting the brain may cause cognitive dysfunction. Many patients with SLE have     mild to severe cognitive impairment involving, for example, short- or long-term memory,     thought processing and relating objects in time and space.      Patients 18 years of age and older with SLE may be eligible for this study. Participants will     undergo the following tests and procedures:        -  Medical history and physical examination, including blood and urine tests        -  Psychiatric interview and questionnaire to assess depression        -  Neuropsychological tests - answering questions given by an examiner or filling out a          test form or questionnaire        -  Tests of cognitive function - answering questions given by an automated computer program          or performing tasks using a computer mouse        -  Magnetic resonance imaging (MRI) of the brain - a test that uses strong magnetic fields          and radio waves to generate images of the brain. The patient lies still on a stretcher          inside a cylinder containing a magnetic field. The patient's head is stabilized with a          plastic strap and foam pads. During the imaging, a substance called gadolinium-DTPA is          injected into an arm vein through a catheter (thin plastic tube). This substance is used          to enhance the images.      Patients may also be asked to undergo an optional procedure called a lumbar puncture (spinal     tap) to examine the relationship between cognitive impairment and the amount of antibodies in     the cerebrospinal fluid (CSF)- fluid that circulates around the brain and spinal cord. For     this procedure a small area of skin on the lower back is numbed with a local anesthetic. A     needle is then inserted in the space between the bones in the lower back, and about 2     tablespoons of CSF is withdrawn through the needle.   "
168197|NCT00042536|"     The purpose of this study is to evaluate the safety and effectiveness of the drugs yohimbine     and naltrexone in treating men with erectile dysfunction (ED) (the inability to achieve or     maintain penile erection for satisfactory sexual performance).      ED is a medical and psychological problem that is usually associated with increased age.     Evidence suggests that specific neurotransmitter systems are involved in the regulation of     sexual function. Yohimbine and naltrexone are drugs that may influence these neurotransmitter     systems. This study will use different doses of yohimbine and fixed doses of naltrexone to     determine their effectiveness in treating ED.      Participants in this study will be screened with a medical history, physical examination,     blood and urine tests, and an electrocardiogram (ECG). The study will consist of three     outpatient visists.   "
168198|NCT00042549|"     The purpose of this study is to determine the effectiveness and safety of using the Medstone     lithotripter to treat single non-calcified gallstones from 4 to 20 mm in diameter.   "
168199|NCT00042562|"     The purposes of this study are to determine:      The safety of duloxetine and any side effects that might be associated with it.      Whether duloxetine can help patients with major depression.      The safety associated with switching from a medication you may be taking for depression to     taking duloxetine.      It is possible that information collected during this study will be analyzed by the sponsor     in the future to evaluate duloxetine for other possible uses or for other medical or     scientific purposes other than those currently proposed.   "
168200|NCT00042575|"     The Purposes of this Study are to determine:      The safety of duloxetine and any side effects that might be associated with it.      Whether duloxetine can help patients with major depression.      It is possible that information collected during this study will be analyzed by the sponsor     in the future to evaluate duloxetine for other possible uses or for other medical or     scientific purposes other than those currently proposed.      Duloxetine might not have any good effects for you.   "
168201|NCT00042588|"     The objective of this study is to demonstrate the safety and efficacy of IC14 in the     treatment of hospitalized patients with community-acquired pneumonia and sepsis.   "
168202|NCT00042601|"     This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over     study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and     obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.   "
168203|NCT00042614|"     This study will investigate the causes of acute and chronic rejection of transplanted hearts.     To find better ways to detect, treat and possibly prevent heart transplant rejection, more     information about the cause is needed. Acute and chronic heart transplant rejection may be     caused by certain substances the body produces in response to the new heart. This study will     try to find a blood or urine test that detects genes and proteins that can serve as markers     of rejection. Such a test may lead to earlier detection and improved treatment.      Patients 18 years and above who are on a wait list for heart transplant at a UNOS-approved     heart transplant center, whose institutional review board has approved this protocol, may be     eligible for this study. Healthy volunteers will also be included in the study to establish a     database of normal values for comparison with patients undergoing heart transplant. In     addition, patients who have had a heart transplant within the past 1 to 5 years will be     enrolled in a pilot study. Normal volunteers will be screened for participation with an     electrocardiogram (EKG) and echocardiogram, non-invasive tests to evaluate heart function.      Participants will undergo the following procedures:        -  Review of medical records Patients who have had a heart transplant and those on a wait          list to receive a heart will have their medical records reviewed to collect information          on their condition.        -  Blood samples 60 cc (about 3 tablespoons) of blood will be collected from all          participants by needle stick in a vein. The sample will be analyzed for genes and          proteins that might predict heart rejection. In addition, many genes in blood cells and          cells lining blood vessels that are unrelated to heart transplant rejection and whose          functions or significance are unknown will also be examined for ideas for future          research. Patients enrolled while on a wait list will, after transplantation, have an          additional 44 cc (about 2 tablespoons) of blood collected at each heart biopsy and          rejection episode during the first year of transplant, and 60 cc collected with each          yearly biopsy for the next 9 years.        -  Urine samples Between 100 and 300 cc (3 to 10 ounces) of urine may be collected from all          participants to confirm blood test results   "
168204|NCT00042627|"     This study will investigate whether people who donate granulocytes (a type of white blood     cell) by leukapheresis are at increased risk of developing cataracts (changes in the lens of     the eye that can impair vision). Apheresis is a method of collecting large numbers of white     blood cells. The procedure is similar to donating whole blood, but the collected blood is     circulated through a cell separator machine, the white cells are extracted, and the rest of     the blood is returned to the donor. Before the procedure, donors are given a steroid called     dexamethasone. This drug temporarily increases the number of granulocytes circulating in the     blood, thus allowing twice as many of these cells to be collected.      Recently, one blood collection center reported greater numbers of cataracts in a small number     of granulocyte donors who had received repeated doses of steroids for granulocyte     mobilization. The donors were unaware that they had the cataracts, which were small and did     not affect their vision. Although people who take high doses of steroids over a long period     time are known to have an increased risk of cataracts, steroids given infrequently (and in     the doses used for granulocyte donation) have not been associated with cataracts. This study     will examine the eyes of granulocyte donors and of platelet donors. Platelets-blood     components necessary for clotting-are also collected by pheresis, but donors are not given     steroids before the procedure. The examination findings will be compared to see if there is a     difference in the risk of cataract formation in the two groups.      People 18 years of age and older who have donated granulocytes or platelets at the NIH     Department of Transfusion Medicine four times or more since 1984 may be eligible for this     study. Participants will undergo the following procedures:        -  Detailed medical history, including allergies, corticosteroid use, diabetes mellitus,          and asthma        -  Detailed eye history, including cataracts, glaucoma, other eye diseases and infections,          eye trauma, and corrective lenses        -  Detailed history of sun exposure        -  Eye examination, including measurement of visual acuity (eye chart test) and eye          pressure, examination of the lens and retina.        -  Photographs of the eye using a special camera   "
168205|NCT00042653|"     This 6 month study will assess an investigational medication for patients on dialysis with     secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone,     calcium and phosphorus levels.   "
168207|NCT00042679|"     The purposes of this study are to determine the following:      Whether LY900003 plus gemcitabine and carboplatin can make your tumor smaller or disappear,     and for how long.      If treatment with LY900003 plus gemcitabine and carboplatin can help you live longer.      The safety of LY900003 plus gemcitabine and carboplatin and any side effects that might be     associated with the combination of these three drugs.      How LY900003 is distributed and broken down by your body when it is given with carboplatin     and gemcitabine.      Whether LY900003 affects the way gemcitabine and carboplatin are distributed and broken down     by your body.   "
168208|NCT00042692|"     The goal of the clinical trial aim in this project is to test whether catechol thioethers can     be used as biomarkers of dopaminergic neurodegeneration.   "
168209|NCT00042705|"     This study measures residential exposures (indoor allergens, mold, nitrogen dioxide,     nicotine) and relates exposure levels to daily symptoms (wheeze, persistent cough, chest     tightness, shortness of breath) and medication use, in a population of children with     physician diagnosed asthma, followed for 12 months.   "
168210|NCT00042718|"     The purpose of this study is to evaluate the safety and effectiveness of four oral antibiotic     treatment regimens for bacterial infections in patients with chronic bronchitis. The study     goals are to demonstrate that 1) levofloxacin 750 mg once daily for three days is no worse     than azithromycin 250 mg twice a day for one day and then 250 mg once a day for four more     days, and 2) levofloxacin 750 mg once daily for five days is no worse than amoxicillin/     clavulanate (875/125 mg) twice daily for 10 days.   "
168211|NCT00042731|"     RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a     substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or     lycopene before surgery may be an effective treatment for prostate cancer.      PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of     lycopene before surgery in treating patients who have stage I or stage II prostate cancer.   "
168212|NCT00042770|"     RATIONALE: It is not yet known whether pleurodesis using a chest tube with infusions of talc     is more effective in improving quality of life than pleurodesis using a small catheter in     treating malignant pleural effusion.      PURPOSE: Randomized phase III trial to compare the effectiveness of a chest tube and talc     with that of a small catheter in treating malignant pleural effusion in patients who have     cancer.   "
168213|NCT00042783|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine     therapy may be effective in treating stage IV melanoma.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients     who have stage IV melanoma.   "
168214|NCT00042796|"     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. This phase I trial is studying the side effects and best dose of decitabine     in treating children with relapsed or refractory acute myeloid leukemia or acute     lymphoblastic leukemia   "
168215|NCT00042809|"     Phase I trial to study the effectiveness of combining erlotinib and trastuzumab with     paclitaxel in treating patients who have advanced solid tumors. Biological therapies such as     erlotinib may interfere with the growth of the tumor cells and slow the growth of the tumor.     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining erlotinib and trastuzumab with paclitaxel may kill more tumor cells   "
168216|NCT00042822|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have     myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.   "
168217|NCT00042835|"     Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their     growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or     die. Combining erlotinib and radiation therapy with combination chemotherapy may kill more     tumor cells. Phase I trial to study the effectiveness of combining erlotinib and radiation     therapy with combination chemotherapy in treating patients who have inoperable stage III     non-small cell lung cancer   "
168218|NCT00042848|"     RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are     undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related     fatigue is not yet known.      PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in     treating fatigue in patients who are receiving chemotherapy for cancer.   "
168219|NCT00042861|"     RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor     cells.      PURPOSE: Phase I trial to study the effectiveness of combining UCN-01, fluorouracil, and     leucovorin in treating patients who have metastatic or unresectable solid tumors.   "
168220|NCT00042874|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining more than one drug may kill more tumor cells. This phase I trial is     studying the side effects and best dose of combination chemotherapy in treating patients with     locally advanced or metastatic solid tumors.   "
168221|NCT00042887|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Infusing chemotherapy drugs directly into the bladder may kill more     cancer cells. It is not yet known if surgery followed by chemotherapy is more effective than     chemotherapy alone in treating bladder cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy alone with     that of transurethral resection followed by chemotherapy in treating patients who have     bladder cancer.   "
168222|NCT00042900|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have     advanced cancer.   "
168223|NCT00042913|"     RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: Randomized phase II trial to study the effectiveness of epratuzumab in treating     patients who have non-Hodgkin's lymphoma.   "
168224|NCT00042926|"     RATIONALE: Diagnostic procedures to detect cancer cells in sentinel lymph nodes may help plan     effective cancer treatment.      PURPOSE: Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph     node lymphadenectomy in patients who are undergoing surgery to remove early-stage cancer of     the mouth.   "
168225|NCT00042939|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and     either kill them or deliver tumor-killing substances to them without harming normal cells.     Combining chemotherapy with cetuximab may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together     with cetuximab to see how well it works compared to irinotecan and docetaxel alone in     treating patients with metastatic pancreatic cancer .   "
168226|NCT00042952|"     Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth. Phase II trial to study the effectiveness of imatinib mesylate in treating     patients who have progressive, refractory, or recurrent stage II or stage III testicular     cancer or stage II or stage III ovarian cancer following cisplatin-based chemotherapy   "
168227|NCT00042965|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining capecitabine with gemcitabine     in treating patients who have metastatic kidney cancer.   "
168228|NCT00042978|"     This phase II trial studies how well carboplatin and etoposide with or without oblimersen     sodium works in treating patients with extensive stage small cell lung cancer. Drugs used in     chemotherapy, such as carboplatin and etoposide, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Biological     therapies, such as oblimersen sodium, may stimulate the immune system in different ways and     stop cancer cells from growing. Giving carboplatin and etoposide together with oblimersen     sodium may kill not tumor cells   "
168229|NCT00042991|"     Biological therapies such as gefitinib may interfere with the growth of the tumor cells and     may make the tumor cells more sensitive to radiation therapy. This phase I/II trial is     studying how well giving gefitinib together with radiation therapy works in treating children     with newly diagnosed glioma.   "
168230|NCT00043004|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread by blocking blood     flow. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not     yet known if chemotherapy is more effective with or without radiofrequency ablation in     treating liver metastases.      PURPOSE: This randomized phase II trial is studying combination chemotherapy, bevacizumab,     and radiofrequency ablation to see how well they work compared to combination chemotherapy     and bevacizumab alone in treating unresectable liver metastases in patients with colorectal     cancer.   "
168231|NCT00043017|"     RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may help determine     the effectiveness of chemotherapy in killing breast cancer and allow doctors to plan more     effective treatment.      PURPOSE: Diagnostic trial to study the effectiveness of MRI in monitoring tumor response in     women who are receiving chemotherapy for stage III breast cancer.   "
168232|NCT00043030|"     RATIONALE: Understanding why patients participate in a phase I clinical trial may help     doctors plan better treatment for cancer.      PURPOSE: This clinical trial is studying to determine the reasons for participation,     perceptions, and expectations of patients receiving treatment for cancer in phase I clinical     trials.   "
168233|NCT00043043|"     RATIONALE: Celecoxib may be effective in preventing colorectal cancer in patients who have a     history of rectal polyps or colorectal neoplasia.      PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing     colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.   "
168234|NCT00043069|"     RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate     cancer may decrease the risk of fractures and may help patients live more comfortably. It is     not yet known whether calcium is more effective with or without estrogen and/or risedronate     in preventing osteoporosis.      PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with     or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate     cancer who are receiving androgen ablation therapy.   "
168235|NCT00043082|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known if carboplatin is more effective with or without liposomal doxorubicin in treating     recurrent ovarian epithelial or primary peritoneal cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of carboplatin with or     without liposomal doxorubicin in treating patients who have recurrent ovarian epithelial or     primary peritoneal cancer.   "
168236|NCT00043095|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with gemcitabine in     treating patients who have advanced solid tumors.   "
168237|NCT00043108|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Giving combination chemotherapy with radiation therapy before and after surgery may shrink     the tumor so it can be removed during surgery and may kill any remaining tumor cells     following surgery.      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin     with radiation therapy and surgery in treating patients who have newly diagnosed locally     advanced non-small cell lung cancer.   "
168238|NCT00043121|"     This phase I trial studies the side effects and best dose of capecitabine when given together     with oxaliplatin, leucovorin calcium, and fluorouracil in treating patients with advanced     cancer that is metastatic or cannot be removed by surgery. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining more     than one drug may kill more tumor cells.   "
168239|NCT00043134|"     RATIONALE: Decitabine may help myelodysplasia cells develop into normal stem cells. It is not     yet known if decitabine is more effective than standard supportive care in treating     myelodysplastic syndrome.      PURPOSE: Randomized phase III trial to compare the effectiveness of low-dose decitabine with     that of standard supportive care in treating older patients who have myelodysplastic     syndrome.   "
168240|NCT00043147|"     RATIONALE: Beclomethasone combined with prednisone may be an effective treatment for     graft-versus-host disease caused by stem cell transplantation. It is not yet known if     prednisone is more effective with or without beclomethasone in treating gastrointestinal     graft-versus-host disease.      PURPOSE: Randomized phase III trial to determine the effectiveness of prednisone with or     without beclomethasone in treating patients who have graft-versus-host disease afftecting the     gastrointestinal system.   "
168241|NCT00043186|"     To determine the effect of denosumab treatment compared with placebo over 12 months on bone     mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical     hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12     months will significantly increase lumbar spine bone mineral density and will be well     tolerated.   "
168242|NCT00043199|"     To determine the rate of response and duration of reponse following therapy with Aroplatin in     subjects with advanced colorectal cancer resistant to standard therapies. Secondary     objectives are to determine safety and tolerability of the Aroplatin therapy.   "
168243|NCT00043212|"     The purpose of this clinical research study is to assess the safety and efficacy of an     investigational therapy called DCVax(TM)-Prostate.   "
168244|NCT00043225|"     This study will examine 1) the role of hereditary factors in cystic fibrosis; i.e., the     relationship of the disease to specific gene variations, and 2) the role of bacterial     products involved in lung infections substances produced by bacteria may worsen the disease.      Patients with cystic fibrosis who are being followed by the Medical College of Wisconsin or     the University of Wisconsin-Madison are eligible for this study. Participants will have blood     tests, pulmonary function tests, a sputum culture, and buccal swabbing (cotton swabbing of     the inside of the cheek to collect cells for DNA study). In addition, their medical records     will be reviewed for a history of lung infections and the results of various tests, including     pulmonary function studies, chest X-rays and bacterial cultures. Blood samples collected     previously at the Medical College of Wisconsin or the University of Wisconsin-Madison will     also be analyzed for antibodies to bacteria.      Although this is a one-time study, participants may be asked to return for repeated tests.   "
168245|NCT00043238|"     This study will determine the pathways between Mohawk cultural identification and specific     behaviors related to pollutant exposure, and determine the effects of these factors and the     pollutant exposure on physiologically and socially significant outcomes.   "
168246|NCT00043264|"     Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central     nervous system (CNS). The etiology of MS is unknown, although the immune system appears to     play a role. Many different infectious agents have been proposed as potential causes for MS,     including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at     Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS     of MS patients. These findings have been replicated in part by other laboratories.      The purpose of the current study is to test whether antibiotic treatment aimed at eradicating     Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will     be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into     the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal     fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these     criteria will be randomized to either placebo or antibiotic therapy, and followed for 6     months on treatment.   "
168247|NCT00043277|"     The goals of this study are:        1. To assess the safety of bivalirudin in infants under six months with arterial or venous          thrombosis;        2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as          measured by the activated clotting time (ACT) or activated partial thromboplastin time          (aPTT) in Infants Under Six Months with arterial or venous thrombosis;        3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution          and bleeding complications compared to patients on unfractionated heparin (UH) or low          molecular weight heparin (LMWH).   "
168574|NCT00034970|"     The purpose of this study is to determine whether cancer patients who receive the     mindfulness-based art therapy (MBAT) program demonstrate improvement in health-related     quality of life, a reduction in stress-related symptoms, and enhanced coping responses.   "
168248|NCT00043303|"     The purpose of this research study is to test the safety and effectiveness of Interferon     gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of advanced     liver fibrosis and cirrhosis in patients with chronic hepatitis C infections.      IFN-g 1b is not currently approved for the treatment of liver fibrosis.   "
168249|NCT00043316|"     The purpose of this research study is to evaluate the safety and effectiveness of Interferon     gamma-1b (IFN-g 1b) on lung function when given to patients with cystic fibrosis by     inhalation (breathed into the lungs) three times a week for 12 weeks.      The FDA has not approved Interferon gamma-1b for use with cystic fibrosis patients, which is     the condition being examined in this study.   "
168250|NCT00043329|"     The purpose of this study is to establish a registry of all children with severe, malignant     osteopetrosis who are treated with Actimmune (IFN-g 1b or Interferon gamma-1b) to monitor the     effects of IFN-g 1b on preventing progression of this disease and to follow the safety of     patients receiving it on a long-term basis. In addition, evaluation of the possible effect of     Actimmune therapy on the humoral response to normal childhood vaccinations in this same     patient population will be examined.Interferon gamma is a substance that the body makes     naturally.   "
168251|NCT00043342|"     The purpose of this research study is to evaluate the safety, tolerability, and efficacy of     Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period     of 4 weeks to patients with mild-to-moderate cystic fibrosis. Additionally, preliminary     assessments on the effects of IFN-gamma 1b on lung function and other indicators of health     will be made.   "
168444|NCT00033046|"     The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its     interactions with intravenous (IV) cocaine.   "
168252|NCT00043355|"     The purpose of this research study is to test the safety and effectiveness of inhaled     Interferon gamma-1b (IFN-g 1b), when administered for 48 weeks and in combination with oral     antibiotics which may be administered for up to 72 weeks for the treatment of a lung     infection caused by a bacterium called Mycobacterium avium complex .      FDA has not approved Interferon gamma-1b for use in patients with MAC infection of the lungs,     which is the purpose of this study.Interferon gamma-1b and similar proteins play important     roles in establishing and maintaining protective immune responses against a variety of     microorganisms.   "
168253|NCT00043368|"     This protocol allows patients who completed Coley oncology studies using PF-3512676 (CPG     7909) Injection to continue receiving the treatment until disease progression.   "
168254|NCT00043381|"     To compare the safety and efficacy profiles of decitabine to those of supportive care in     adults with advanced-stage myelodysplastic syndrome (MDS)   "
168255|NCT00043394|"     To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients     with metastatic breast cancer.   "
168256|NCT00043407|"     CPG 7909 given alone to patients with renal cell cancer after their nephrectomy. CPG 7909 is     as a subcutaneous injection once per week for up to 24 weeks. Up to 40 patients will be     included in the study.   "
168257|NCT00043420|"     To assess the effect of CPG 7909 Injection on Cutaneous T-cell lymphoma and the safety of CPG     7909 Injection in patients with this cancer.   "
168258|NCT00043433|"     The purpose of the study is to determine whether T900607-sodium is effective and safe in     treating hepatocellular carcinoma, a type of liver cancer.   "
168259|NCT00043446|"     The purpose of this study is to determine whether T900607-sodium is effective and safe in     treating ovarian cancer.   "
168260|NCT00043459|"     The purpose of the study is to determine whether T900607-sodium is effective and safe in     treating non-Hodgkin's lymphoma.   "
168261|NCT00043472|"     This study will evaluate women who are at increased genetic risk of developing ovarian cancer     because they or a close relative have a mutation in the BRCA1 or BRCA2 gene (the genes that     cause most of the genetic forms of ovarian cancer) or because they have a very strong family     history of breast and/or ovarian cancer. The study has two aspects. There will be two groups     of subjects in this study. One group of women who will have their ovaries and fallopian tubes     surgically removed as a prophylactic (preventive) measure against developing     ovarian/fallopian tube cancer. These women will be studied to determine whether the surgery     does, in fact, decrease the risk of ovarian or tubal cancer and whether it decreases the risk     of breast and other cancers. The tissue removed at surgery will also be investigated to see     whether a new way of examining the ovaries after they are removed provides better information     about cancer-related tissue changes. A second group of subjects will be women who choose not     to have preventive surgery. These women will be followed closely to see if screening with     multiple CA-125 blood testing over time (see below) can detect ovarian or tubal cancers in     their early stages. Both groups of women will undergo examination of the process by which     women decide upon various options for lowering their ovarian cancer risk and a detailed     assessment of how their choice impacts their quality of life. It will look at how those who     opt for ovariectomy feel after their surgery and how those who choose screening feel during     the time of screening.      All participants will undergo the following procedures:        -  Medical history, physical examination, and blood drawing upon entering the study,          including blood samples for future ovarian cancer research.        -  Screening mammogram, CA-125 blood test, and transvaginal ultrasound upon entering the          study, with yearly repeat mammograms for all participants and yearly transvaginal          ultrasound exams for women in the screening arm of the study. CA-125 is a protein found          in the blood whose levels are elevated in most women with ovarian cancer. Transvaginal          ultrasound is a way of taking pictures of the ovaries using sound waves. If the results          of these tests are not normal, additional tests may be required to learn the reason for          the abnormality.        -  Questionnaires about personal, medical and family history, ovarian cancer risk factors,          medication use, medical choices, and quality of life on entering the study, with repeat          quality of life and medication use questionnaires every 6 months during the study          period.        -  Blood samples for follow-up visits and for CA-125 testing every 3 months as a screen for          ovarian/fallopian tube cancers. Some blood from these samples will be saved for future          ovarian cancer research.        -  Semi-annual report during the duration of the study regarding health and quality of life          changes that occur over the prior 6-month period.      Researchers will use the pattern and rate of change of CA-125 levels over time in women in     the screening group to decide if more tests are needed to test for ovarian cancer. Women in     the surgery portion will undergo surgical removal of their ovaries and fallopian tubes. The     removed tissues will be studied using new methods to examine the cells more closely than     usual, and a portion of the tissues will be stored for future research on ovarian cancer.     This study is being conducted in collaboration with the Gynecologic Oncology Group (GOG), and     is designated GOG Protocol 0199. Subjects may join the study at any participating GOG     institution (http://www.gog.org).   "
168262|NCT00043498|"     A molecular epidemiologic study of African American and Hispanic mothers and newborns to     investigate the role of common urban pollutants on procarcinogenic and developmental damage.   "
168263|NCT00043511|"     The purpose of this study is to see if the experimental HIV vaccine pGA2/JS2 is safe and is     well tolerated at two different doses. Another important purpose of this study is to observe     how the immune system responds to the vaccine at different dose levels.      Vaccines are given to people to help their bodies fight infection. The vaccine being tested     in this study is a DNA vaccine. The pGA2/JS2 plasmid DNA vaccine instructs the body to make     some HIV proteins. These HIV proteins may trigger an immune response. Because only a few of     the many proteins HIV needs are made through DNA vaccination, there is no risk of getting HIV     from the vaccination. This and other similar DNA vaccines have been tested for safety in     mice, rabbits, and monkeys. The vaccine has been well tolerated at doses to be used in this     study.   "
168264|NCT00043537|"     This 4-year study will compare the long-term effectiveness of behavioral treatment,     fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.   "
168265|NCT00043550|"     This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®),     venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which     is more effective in treating major depression.   "
168266|NCT00043563|"     This study will compare the effectiveness of cognitive-behavior therapy (CBT) to a minimal     attention control (AC) condition for treatment of pediatric trichotillomania (TTM).   "
168267|NCT00043576|"     The purposes of this study are to determine if DN-101 plus Taxotere lowers PSA levels, delays     or limits disease progression and is safe with minimal side effects.   "
168268|NCT00043589|"     This study will evaluate the effectiveness of donepezil (Aricept®) and cognitive training in     improving memory performance in elderly adults.   "
168269|NCT00043602|"     This 12-week study will evaluate the effectiveness of Clinician-Managed Interpersonal     Psychotherapy (CM-IPT) in treating postpartum depression and will compare CM-IPT to standard     IPT.   "
168278|NCT00043719|"     Osteopenia and osteoporosis cause thinning of bone tissue and loss of bone density over time.     The purpose of this study is to determine the safety and effectiveness of nitroglycerin     ointment for the treatment of osteopenia in postmenopausal women.      Study hypothesis: On average, participants in the base therapy cohort who receive placebo     ointment control and calcium/vitamin D will lose more bone density than participants in the     nitroglycerin cohort over the 36-month period.   "
168567|NCT00034866|"     The purpose of this research study is to determine which of three different dose combinations     of tipranavir and ritonavir, when taken with a standard approved anti-HIV drug therapy, is     most effective and safe. Tipranavir is an investigational protease inhibitor which has been     demonstrated to have in vitro activity against HIV-1.   "
168270|NCT00043615|"     This study will collect biological samples-blood, bone marrow, tumor or other tissue     samples-for use in cancer-related research. The specimens will be used for various tests of     drug resistance, blood vessel formation, cancer-causing proteins and immune functions. The     purpose is to identify steps in the cancer development process that may serve as targets for     treatment and to test various therapies for current and future cancer treatment clinical     trials.      Individuals 18 years of age and older with cancer or a pre-cancerous condition, such as colon     polyps or cervical dysplasia, are eligible for this study, as are patients at high risk for     cancer. In addition, patients who do not have cancer but require surgery, biopsy or other     procedure for another medical reason may be included as normal specimen donors.      Participants will have about 40 milliliters (3 tablespoons) of blood drawn upon entering the     study and additional 40-ml samples drawn periodically during the course of treatment. No more     than 120 ml of blood will be drawn over a 12-month period. Some patients may require a     surgical procedure or biopsy (removal of tumor tissue) for medical reasons or as part of     their enrollment in a research treatment study. In such cases, a portion of the specimens     collected during those procedures will be used for the research studies in this protocol.   "
168305|NCT00031096|"     Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female     patients with mild to moderate acne.      Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks.     Subjects will be required to return to the doctor's office for up to 5 visits.   "
168271|NCT00043628|"     This two-part study will determine whether stem cells (primitive cells produced by the bone     marrow that can develop into blood cells or other types of cells) can be pushed out into the     bloodstream, relocate in the heart, and grow new heart muscle and blood vessels in patients     with chest pain caused by narrowing of their coronary (heart) arteries. The new blood vessels     may enable patients to do more activities before experiencing chest pain. Part 1 of the study     will evaluate in a small number of patients whether an increase in white blood cells     following administration of G-CSF (a drug used to move stem cells from the bone marrow to the     bloodstream) is safe in people with coronary heart disease. Part 2 will evaluate the effects     of the circulating stem cells on heart function.      Patients 21 years of age and older with coronary artery blockage that limits blood flow to     the heart (as shown by coronary angiography within 6 months of entering the study) and causes     chest pain that interferes with the ability to carry out daily living activities may be     eligible for this study. Candidates will be screened with blood tests, an exercise test,     magnetic resonance imaging (MRI), and 24-hour Holter monitoring of heart rate and rhythm.     Participants will undergo the following tests and procedures:      Part 1: Patients will be hospitalized at the NIH Clinical Center for 5 days. On the first day     after admission, an indwelling catheter (short plastic tube) will be placed in an arm vein to     avoid multiple needle sticks for blood sampling. Patients will then exercise on a treadmill.     Blood samples will be drawn before the exercise test and 2 hours after the test. The next 2     days, patients will receive a daily injection of G-CSF under the skin. Blood samples will be     drawn every day for 5 days to monitor the effect of G-CSF on moving cells into the     bloodstream. Additional samples will be drawn to determine the effects of G-CSF on the number     of stem cells that become heart cells, as well as any effects on blood clotting ability.     After discharge for the hospital, patients will return to the clinic 2 weeks after the     initiation of G-CSF treatment for a physical examination, blood tests, and a treadmill     exercise test. One month after the initiation of treatment, patients will return to the     clinic for a physical examination, blood tests, treadmill exercise test, an MRI study, and     fitting with a Holter monitor for 24-hour heart monitoring.      Part 2: Patients will be hospitalized at the NIH Clinical Center for 5 days, undergoing the     same procedures as in Part 1, except they will receive G-CSF for 5 days instead of 2. They     will also undergo the same procedures detailed for the 2-week and 1-month follow-up visits.     Then, at 3 months they will again return to the clinic for a physical examination, routine     blood tests, and a treadmill exercise test. This concludes formal participation in the study.     However, patients are requested to return to the outpatient clinic once a year for follow-up.   "
168272|NCT00043641|"     This study will investigate low-level viral loads in HIV-infected patients taking highly     active antiretroviral therapy (HAART). Although HAART reduces viral levels and restores     immune function to some degree, it does not cure HIV infection. The virus persists even at     levels below that which it can be detected. This study will examine where this residual virus     comes from in order to better understand the infection and the effectiveness of therapies. In     addition, the study will 1) evaluate the ability of a new test to detect the virus at low     levels; and 2) determine whether adding the protease inhibitor Kaletra to the HAART treatment     regimen for patients with a low viral load will further decrease their viral load.      HIV-infected patients 18 years of age and older may be eligible for this study. Patients     involved in the viral load test will be recruited from an NIAID HIV study in which they are     already participating. Three groups of patients will be enrolled: those with a viral load of     less than 50 copies/ml plasma, those with 51-500 copies/ml, and those with 501-5000     copies/ml. Patients involved in the Kaletra trial must have been taking HAART for 6 months or     more and have less than 50 viral copies/ml plasma. They will be screened for this study with     a history, physical examination, and routine laboratory tests.      Participants in the viral load test evaluation will donate 70 ml of blood up to four times.     No more than one sample will be collected per day.      Participants in the Kaletra trial will have blood samples drawn on two successive days and     will then be randomly assigned to one of two treatment groups. One group will begin Kaletra     therapy (four capsules two times a day) immediately; the other will undergo observation for 4     weeks before starting Kaletra. Depending on what group they are in, patients will provide     blood samples for viral load measurements and clinical samples according to the following     schedule:      Immediate Kaletra      One sample each during weeks 1, 2, and 3, of therapy and two samples during week 4.      Delayed Kaletra      One sample each during weeks 1, 2, and 3 of observation and two samples during week 4. After     starting therapy, one sample will be collected each week during weeks 1, 2, and 3 of therapy     and two samples during week 4.      In both groups, after the last dose of medicine on day 28, Kaletra therapy will be complete.     At the end of therapy, additional blood will be collected for viral sampling as follows: one     sample each during weeks 1, 2, and 3, and two samples during week 4 after Kaletra therapy.   "
168273|NCT00043654|"     Bipolar Depression is a severe illness with high rates of psychiatric comorbidity and     increased mortality related to suicide and medical illness. Hypothalamic pituitary axis (HPA)     hyperactivity are found in bipolar disorder related to depression and mixed states. Patients     with bipolar disorder also have cognitive difficulties and endocrine disturbances may     contribute to such dysfunction. Antiglucorticoid therapies are novel treatments of mood     disorder. Preliminary data in psychotic depression suggesting that mifepristone (RU-486), a     glucocorticoid receptor antagonist, has antidepressant and salutary cognitive effects in a     matter of days. In this study we examine the effects of mifepristone in severe bipolar     depression in a parallel, double blind placebo controlled experiment. Bipolar subjects     maintained on either lithium or valproate, after washout or prior antidepressants have a     detailed neuroendocrine assessment. Patients approximately or almost 75 will receive eight     days of mifepristone versus placebo after which patients are blindly crossed over to the     opposite arm. Patients and a group of matched controls approximately or almost 35 will be     compared with neuroendocrine, cognitive, and neurophysiologic testing to fully characterize     their phenotype and explore biomarkers of response. It is hypothesized that stigmata of HPA     axis hyperactivity and cognitive impairment will be predictive of response to     antiglucocorticoid therapy with mifepristone.   "
168274|NCT00043667|"     This study will examine the safety and effectiveness of a monoclonal antibody called     daclizumab in treating uveitis, an eye inflammation. Monoclonal antibodies are genetically     engineered proteins made in large quantities and directed against a specific target in the     body. Daclizumab is designed to prevent a specific chemical interaction needed for immune     cells called lymphocytes to produce inflammation. In an ongoing NIH study of 10 adults with     uveitis, 8 patients were able to decrease corticosteroids and other immunosuppressive     medicines they were taking while receiving daclizumab for months or even years. The study     will be conducted at three different sites, including the NIH Clinical Center.      Patients 6 years of age and older with non-infectious uveitis of at least 3 months' duration     who require treatment with immune suppressing medicines, such as prednisone,     cyclophosphamide, cyclosporine, azathioprine, methotrexate, or others, may be eligible for     this study. Candidates will be screened with a medical history and physical examination,     blood tests, complete eye examination, and a questionnaire about the patient's vision and     daily activities.      Participants will come to the study center every 2 weeks for treatment and evaluation.     Daclizumab treatments are given by injection under the skin, usually in the arm. Patients     will receive a maximum of 28 treatments over a 1-year period. Treatment may be extended for a     few months while other participants reach their 1-year mark. The first two induction     treatments are at a higher dose (2 mg/kg of body weight) than the maintenance dose of 1     mg/kg. After the first daclizumab treatment, other uveitis medications will be tapered, one     at a time. If the disease remains quiet, these drugs may eventually be stopped completely.      For the first 6 months, all patients will receive daclizumab injections and evaluations every     2 weeks. After that, if other medications have been reduced and vision has remained stable,     treatments and evaluations may be spread out to every 3 or 4 weeks. Over time, fewer tests     may be required during the biweekly examinations if the patient is doing well, but nearly all     the examinations done at screening will be repeated at 3-month intervals. If inflammation or     vision loss occurs during drug tapering, appropriate treatment will be administered. If the     vision loss is too great, the patient will be treated with steroids or other medicines and     taken off the study.      Additional, special tests done at selected study centers include the following:        -  Fluorescein angiography: This test is done to check for abnormalities of eye blood          vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in          the eyes. Pictures of the retina are taken with a special camera that flashes a blue          light into the eye. The pictures show if any dye has leaked from the vessels into the          retina, indicating possible abnormalities.        -  Pelvic ultrasound and urine test: These tests are done at enrollment and after 1 year to          check the kidneys, lymph nodes, and pelvic area.        -  Blood tests: Additional blood tests are done at enrollment and every 3 to 6 months for          laboratory and immunology study.   "
168275|NCT00043680|"     This study will determine whether the drug celecoxib (Celebrex® (Registered Trademark)) can     help stabilize or improve vision in patients with age-related macular degeneration (AMD) who     are receiving photodynamic therapy, or PDT (also called cold laser treatment). The macula is     the part of the retina in the back of the eye that determines central or best vision. AMD can     severely impair central vision, affecting a person's ability to read, drive, and carry out     daily activities. This vision loss is caused by the formation of abnormal new blood vessels     in the choroid-a thin, pigmented vascular layer of the eye behind the retina-that leak blood     under the macula. PTD stops the growth of these blood vessels and slows the rate of vision     loss. However, the treatment usually does not cause vision to improve, and it has only a     temporary effect, requiring several treatments over 2 years. Furthermore, PDT does not work     in all patients and may actually cause some swelling and re-growth of blood vessels.     Celecoxib is an anti-inflammatory drug that, in animal studies, has prevented the growth of     abnormal blood vessels associated with tumors and with injury to the cornea. Thus, the drug     might reduce swelling and prevent vessel re-growth in AMD, enhancing the effectiveness of     PDT.      Patients 55 years of age and older with AMD and visual acuity of 20/20 to 20/200 may be     eligible for this study. Participants will be randomly assigned to take either celecoxib or a     placebo (a look-alike pill with no active drug) twice a day and undergo the various tests and     procedures detailed below. Not every examination will be done at every visit, but all may be     required at one visit.        -  Medical history and physical examination        -  Blood drawing: A blood sample is drawn from an arm vein to evaluate liver and kidney          function        -  Eye examination: Visual acuity and eye pressure are measured, and the lens, retina,          pupils and eye movements are examined        -  Photography: Photographs of the eye are taken using a special camera with a bright flash        -  Fluorescein angiography: Pictures of the retina are taken to look for abnormal blood          vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in          the eyes. The retina is photographed using a camera that flashes a blue light into the          eye. The pictures show if any dye has leaked from the vessels into the retina,          indicating possible blood vessel abnormality.        -  Indocyanine green angiography: This procedure, similar to fluorescein angiography, uses          a green dye to photograph the retina and identify portions of abnormal vessels in the          deepest part of the retina.        -  Optical coherence tomography: This new technique uses light to produce a 2-dimensional          cross-sectional picture of the retina. The patient looks into a machine called an          optical coherence tomograph at a pattern of flashing and rotating red and green lights,          first with one eye and then the other.      One week after starting the study medications, laser treatment will begin. For this     procedure, a needle is placed in an arm vein and a chemical called verteporfin (Visudyne®     (Registered Trademark)) is infused into the vein over 10 minutes. After 15 minutes, the eye     is anesthetized with numbing drops. A special contact lens is then placed on the eye and the     laser beam is directed to the eye for 83 seconds.      Patients will be followed in the clinic every 6 weeks for 36 weeks for various examinations     and possible re-treatment, if needed. Some patients will be asked to return 1 to 2 weeks     after the first PDT for an eye examination and fluorescein angiography.   "
168276|NCT00043693|"     This study will evaluate a family intervention program for individuals with bipolar disorder,     schizophrenia, or schizoaffective disorder and co-occurring substance use disorders.   "
168277|NCT00043706|"     Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the     connective tissue generally classified as one of the rheumatic diseases. Systemic Sclerosis     causes fibrosis (scar tissue) to be formed in the skin and internal organs. The fibrosis     eventually causes the involved skin to harden, limiting mobility, and can also damage other     organs. Excess Transforming Growth Factor Beta-1 (TGF-beta1) activity may result in the     abnormal fibrosis characteristic of Systemic Sclerosis. An antibody against TGF-beta1 may     modify pathologic processes characterized by inappropriate fibrosis. Genzyme Corporation is     currently investigating a human monoclonal antibody (CAT-192) that neutralizes active     TGF-beta1. This study is being conducted in the U.S. and Europe to evaluate the safety,     tolerability, and pharmacokinetics of repeated treatments with CAT-192 in patients with early     stage diffuse Systemic Sclerosis.   "
168575|NCT00034983|"     A clinical study to determine the efficacy and safety of an investigational medication     (MK0869) in the treatment of depression   "
168279|NCT00043732|"     The main objective of the study is to evaluate the safety and tolerability of six escalating     doses of SCIO-469 in RA patients. SCIO-469 belongs to a new class of treatments that inhibit     p38 kinase, a stimulatory modulator of pro-inflammatory factors including tumor necrosis     factor-alpha (TNF-alpha), interleukin-1 (IL-1), and cyclooxygenase-2 (COX-2), all of which     are known to contribute to both symptoms and disease progression in patients with Rheumatoid     Arthritis.   "
168280|NCT00043745|"     This study will provide valuable data on whether soy isoflavones impact bone loss in     postmenopausal women. The study will help clarify potential mechanisms and contribute to our     understanding of isoflavones as an alternative to traditional hormone therapy.   "
168281|NCT00043758|"     The purpose of this study is to study the effects of tolvaptan on the size and function of     the left heart chamber (ventricle) in patients with congestive heart failure (CHF)   "
168282|NCT00043771|"     Patients with congestive heart failure will be assessed for safety and clinical effects of     Tolvaptan 30 mg every day versus 15 mg twice a day over a period of 7 days.   "
168285|NCT00043810|"     Patients with Acute Myelogenous Leukemia or Myelodysplastic are able to achieve a complete     remission but fail to achieve a prolonged disease-free survival. High dose chemotherapy and     autologous bone marrow transplantation has been shown to be effective in this group of     patients but hematopoietic recovery is slow, and infectious or bleeding complications are     common. The delay in hematopoietic recover is accentuated by the use of purging techniques.     This is a novel purging approach for autologous stem cell transplantation in patients with     Acute Myelogenous Leukemia or Myelodysplastic syndrome to allow for rapid engraftment with a     lower relapse rate therefore improving the therapeutic outcomes   "
168286|NCT00043823|"     Primary Objectives:        1. (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the          combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced          Non-small-cell lung carcinoma (NSCLC).        2. (Phase II) To assess response rate and tolerability of the regimen at the dose level          established in the phase I portion of this study.      Secondary Objectives:        1. (Phase I and II) To evaluate the pharmacokinetic interaction between the combination.        2. (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for          further study alone or in combination with cytotoxic chemotherapy.   "
168287|NCT00043836|"     The purpose of this study is to test the hypothesis that treatment with oral ALT-711 twice     daily for 16 weeks will improve aortic distensibility, exercise tolerance, and quality of     life in elderly patients with isolated diastolic heart failure (DHF), and that the     improvements in exercise tolerance will correlate with the improvements in aortic     distensibility.   "
168288|NCT00043849|"     The primary aim of this study is to determine the safety and efficacy of quetiapine     (Seroquel) for the treatment of psychosis and/or agitation in patients with primary dementia     complicated by coexistent parkinsonism, or patients with Parkinson's disease with dementia     [PDD] who have episodes of agitation or psychosis. The secondary aim is to determine the     safety and tolerability, particularly the influence on parkinsonism, of quetiapine when used     to treat psychosis and/or agitation in patients with dementia complicated by coexistent     parkinsonism.   "
168289|NCT00043862|"     This study will gather information on the effectiveness and safety of a treatment program for     small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation     therapy, and an oral investigational drug that may enhance the effects of radiation therapy.     Study patients will receive two additional courses of the standard chemotherapy combination     after completing radiation therapy.   "
168290|NCT00030888|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of UCN-01 in treating patients who have     unresectable stage III or stage IV kidney cancer.   "
168291|NCT00030901|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. The use of selenium may be an effective way to prevent prostate cancer     in patients who have neoplasia of the prostate.      PURPOSE: Randomized phase III trial to study the effectiveness of selenium in preventing     prostate cancer in patients who have neoplasia of the prostate.   "
168292|NCT00030914|"     RATIONALE: Medroxyprogesterone and venlafaxine may be effective in relieving hot flashes. It     is not yet known whether venlafaxine is more effective than medroxyprogesterone in relieving     hot flashes.      PURPOSE: Randomized phase III trial to compare the effectiveness of medroxyprogesterone with     that of venlafaxine in treating women who are experiencing hot flashes.   "
168299|NCT00031018|"     In this phase I-II parallel design, randomized, double-blind clinical trial we will determine     if 3,000 or 30,000 units ingested hrIFN-a prevents deterioration of cognitive functioning in     patients with dementia of Alzheimer's type (AD) and whether ingested hrIFN-a treatment     decreases acute phase reactants and pro-inflammatory cytokine IL-6 in mild to moderate AD. We     predict that the novel anti-inflammatory agent ingested human recombinant interferon alpha     (hrIFN-a) will modulate inflammation and inhibit the natural history of AD progression. If     you are eligible, you will receive Aricept for 5 weeks (donezepil) and thereafter in addition     to Aricept either placebo (inactive substance) or interferon alpha at 3,000 or 30,000 units     every day for 12 months.   "
168300|NCT00031031|"     The Kanglaite Injection (KLT)is a novel broad spectrum anti-cancer injection produced from     traditional Chinese medicinal herbs (the Coix Seed). It was approved in China in 1995 and has     become the most popular anti-cancer drug in China. In June of 2001, the Phase I study of KLT     commenced at the Huntsman Cancer Institute in Salt Lake City, Utah, with the objectives of 1)     To determine the maximum tolerated dose (MTD) and the safety profile of KLT in patients with     refractory solid tumors; 2) To determine the pharmacokinetics of KLT in patients with     refractory solid tumors; and 3) To gather preliminary efficacy data. The method of testing is     open-label, sequential cohort, dose-escalation study.   "
168576|NCT00035009|"     A clinical study to determine the efficacy and safety of MK0869 in the treatment of     depression   "
168302|NCT00031057|"     The purpose of this study is to see if vitamin B can treat mild hyperlactatemia (a higher     than normal level of lactate in the blood) in patients who take nucleoside reverse     transcriptase inhibitors (NRTIs).      Hyperlactatemia is a potentially life-threatening condition that can be associated with NRTI     therapy. A lack of vitamin B may be related to the development of hyperlactatemia. However,     no studies have been done to evaluate this. This study proposes that high doses of vitamin B     may bring elevated lactate levels back to normal among patients taking NRTIs.   "
168303|NCT00031070|"     The purpose of this study is to see if cyclosporine, taken when a patient begins highly     active antiretroviral therapy (HAART), increases the number of CD4 T-cells (blood cells that     fight infection) in a patient's blood. This study also will explore the safety of briefly     giving cyclosporine to patients starting HAART.   "
168304|NCT00031083|"     In this study an investigational replication-defective, recombinant adenovirus expressing the     interferon-beta gene (BG00001) will be directly injected into tumors, in patients with     recurrent Grade III and Grade IV Gliomas, in order to deliver the hIFN-beta gene. The purpose     of the study is to evaluate the safety and any harmful effects of injection of BG00001 into     brain tumors. Also, this study will help determine whether the virus carrying the beta     interferon gene will enter brain tumor cells and cause the cancer cells to die. This study     will require one hospital admission for the actual procedure of drug administration. All     other visits will be conducted on an out-patient basis   "
168293|NCT00030940|"     This study will explore the role of various immune factors involved in producing the disease     symptoms in stiff-person syndrome (SPS) and follow disease progression in patients. SPS is a     progressive disease in which unexpected noises, touches or stressful events set off muscle     spasms and stiffness. It is thought to be an autoimmune disease in which the body produces     antibodies that attack certain healthy tissues. A better understanding of the disease may     help researchers design new therapies.      Patients of any age with SPS may be eligible for this study, except those who:        -  Lack of serum anti-GAD antibodies        -  Have very advanced disease that precludes traveling        -  Have severe cardiovascular, renal, or other end-organ-disease states      Candidates will be screened with a medical history and physical and neurological examinations     to confirm the diagnosis of SPS.      After screening, those enrolled in the study will be followed at the NIH Clinical Center     every 6 months for 2 years (months 6, 12, 18, and 24) to have the following tests and     procedures:        -  Physical and neurological examinations and review of symptoms (every visit)        -  Blood draw for routine tests and for research studies (every visit)        -  Stiffness assessment (every visit) - Patients are asked a series of questions about          their stiffness, which physicians rate according to the number of stiff areas (e.g.,          0-no stiff areas; 1-stiffness of the lower trunk; 2-stiffness of the upper trunk, etc.).        -  Lymphapheresis (at the beginning of the study and at 12 months) - This is a procedure          for collecting large quantities of white blood cells. A needle is placed in a vein in          the arm. Blood flows from the vein through a plastic tube (catheter) into a machine that          spins the blood, separating it into its components. The white blood cells (lymphocytes)          are removed, and the rest of the blood-plasma, red cells and platelets-is returned to          the body through a second needle placed in the other arm.        -  Electrophysiologic studies - These studies include electromyography and nerve conduction          testing. For electromyography, a small needle is inserted into a few muscles and the          patient is asked to relax or to contract the muscles. The electrical activity of the          muscle cells is recorded and analyzed by a computer. For nerve conduction testing,          nerves are stimulated through small wire electrodes attached to the skin, and the          response is recorded and analyzed.        -  Lumbar puncture (at the beginning of the study and at 12 months) - This procedure is          done to examine the cerebrospinal fluid (CSF), which bathes the brain and spinal cord.          After a local anesthetic is administered, a needle is inserted in the space between the          bones in the lower back where the CSF circulates below the spinal cord. About 2          tablespoons of fluid is collected through the needle.   "
168294|NCT00030953|"     This study will use magnetic resonance imaging (MRI) and magnetic resonance spectroscopy     (MRS) of the brain to try to gain a better understanding of the disease process in Tourette s     syndrome, a neuropsychiatric disorder characterized by motor and vocal tics. Tourette s     syndrome is also associated with behavioral and emotional disturbances, including symptoms of     attention deficit hyperactivity disorder (ADHD) and obsessive-compulsive disorder (OCD). MRI     and MRS show chemical substances in the brain. Findings in normal volunteers will be compared     with those of patients.      Healthy volunteers and patients with Tourette s syndrome 14 years of age and older may be     eligible for this study. Volunteers will be screened with a medical history and physical and     neurological examinations. Patients will be screened through NINDS protocol 93-N-0202.      Participants will undergo MRI and MRS. MRI uses a strong magnetic field and radio waves to     visualize brain anatomy and chemistry. For this study, the subject lies on a stretcher, which     is moved into a strong magnetic field (the MRI scanner). Earplugs are worn to muffle loud     thumping noises caused by the electrical switching of the radio frequency circuits. During     the study, the subject lies still during each scan, for 1 to 8 minutes at a time. Total     scanning time varies from 20 minutes to 2 hours, with most examinations lasting between 45     and 90 minutes. The subject can speak through an intercom with the staff member performing     the study at all times during the procedure. Up to 5 studies may be performed.   "
168295|NCT00030966|"     The purpose of this study is to determine if natalizumab in combination with AVONEX is safe     and effective in delaying progression of individuals diagnosed with relapsing remitting     Multiple Sclerosis (MS).   "
168296|NCT00030979|"     This study will evaluate the safety and effectiveness of donepezil (Aricept) for treating     mild dementia in patients with Parkinson's disease. Donepezil is approved for treating     patients with Alzheimer's disease, whose memory and cognition problems are similar to those     of patients with Parkinson's disease who are affected by dementia. Donepezil prevents the     breakdown of a chemical messenger called acetylcholine, which is involved in memory and other     cognitive functions, and may improve cognition in patients.      Patients 40 years of age and older with Parkinson's disease who have mild to moderate     dementia may be eligible for this 6-month study. It involves 6 clinic visits of approximately     2 hours each, described below. Candidates will be screened for participation during Visit 1.        -  Visit 1 (screening visit): Study candidates will have a medical history, physical and          neurological examinations, electrocardiogram (EKG), and possibly blood tests. They will          also undergo neuropsychological testing (tests of memory, language, mood and, other          brain functions) and fill out a quality of life questionnaire. Those enrolled will be          randomly assigned to receive either donepezil (5 mg per day) or placebo-a look-alike          pill with no active ingredients. After 4 weeks, the dose of donepezil will be increased          to 10 mg per day. Patients who do not tolerate the higher dose will have it reduced to 5          mg. Those who do not tolerate the 5-mg dose will be taken off medication but will          continue to be followed and tested.        -  Visit 2 (week 7): Patients will have a neurological examination and neuropsychological          testing and will fill out a quality of life questionnaire.        -  Visit 3 (week 10): Patients will repeat the evaluations done during visit 2 and will          stop taking the study medication.        -  Visit 4 (week 16): Patients will repeat the evaluations done during visit 2 and will          have their study medication switched. That is, patients previously on placebo will be          switched to donepezil, and patients who were taking donepezil will be switched to          placebo. After 4 weeks, the dose of donepezil will be increased to 10 mg per day.          Patients who do not tolerate the higher dose will have it reduced to 5 mg. Those who do          not tolerate the 5-mg dose will be taken off medication but will continue to be followed          and tested.        -  Visits 5 and 6 (weeks 23 and 26): Patients will repeat the evaluations done during visit          2.      This study is being conducted at the National Institutes of Health, the University of     Pennsylvania, and Northwestern University   "
168297|NCT00030992|"     This study will examine whether the experimental drug BMS 247550 (Ixabepilone) is an     effective treatment for kidney cancer. BMS 247550 belongs to a class of drugs called     epothilones that interfere with the ability of cancer cells to divide. In the way they kill     cells, they are very similar to a class of compounds known as the taxanes, which include the     drug Taxol. Other characteristics of the epothilones, however, enable them to work in cells     that are resistant to Taxol.      Patients 18 years of age or older with kidney cancer that has not spread to the central     nervous system (unless the brain tumor has remained stable for at least six months after     surgical or radiation treatment) may be eligible for this study. Pregnant or nursing women     may not participate. Candidates are screened with various tests that may include blood and     urine tests, electrocardiogram (EKG), and chest x-ray. Computerized tomography (CT) scans or     X-rays, and possibly nuclear medicine studies may be done to determine the extent of disease.      Participants receive BMS 247550 by a 1-hour infusion into a vein for 5 consecutive days (days     1, 2, 3, 4 and 5) of each 21-day treatment cycle. Patients must stay in the National     Institutes of Health (NIH) area near Bethesda, Maryland, for 7 to 8 days during the first     treatment cycle and for the 5 days of treatment in subsequent cycles. The total number of     cycles will vary among patients, depending on their individual clinical situation. The drug     dose may be increased gradually in subsequent cycles in patients who can tolerate such     increases. In addition, participants undergo the following tests and procedures:        -  Periodic physical examinations and frequent blood tests        -  X-ray and other imaging studies to determine if the tumor is responding to the          treatment.        -  Tumor biopsies to confirm the diagnosis or spread of tumor and to examine the reaction          of certain proteins in cancer cells to BMS 247550. Two biopsies will be done. For this          procedure, a small piece of tumor tissue is withdrawn through a needle under local          anesthetic.      Treatment will be stopped in patients whose tumor grows while receiving BMS 247550. Patients     whose tumor disappears completely will be followed at NIH periodically for examinations and     tests. Patients whose disease does not completely resolve or whose disease recurs may be     advised of other appropriate research protocols at NIH or, if none are available, will be     returned to the care of their local doctor.   "
168298|NCT00031005|"     This study will investigate the safety and effectiveness of a modified stem cell transplant     procedure for treating leukocyte adhesion deficiency (LAD). LAD is an inherited blood     disorder of leukocytes (infection-fighting white blood cells) that leaves patients vulnerable     to life-threatening infections. Transplantation of donated stem cells (cells produced by the     bone marrow that mature into blood cells) can improve the immune system of patients with LAD.     However, this procedure carries a significant risk of death, particularly in patients with     active infection because it requires completely suppressing the immune system with high-dose     chemotherapy and radiation. In addition, T-cells (a type of white blood cell) from the donor     may cause what is called graft vs. host disease (GvHD), in which the donor cells recognize     the patient's cells as foreign and mount an immune response to destroy them. To try to reduce     these risks, the donor's T-cells will be removed from the rest of the stem cells to be     transplanted.      Patients with LAD who weigh at least 12 kg (26.4 LB), who do not have an active infection,     and who have a family member that is a well-matched donor may be eligible for this study.     Pregnant or breast feeding women may not participate. Candidates will have a medical history,     physical examination and blood tests, lung and heart function tests, X-rays or computed     tomography (CT) scans of the body, and dental and eye examinations. They will fill out     questionnaires that measure emotional well being, quality of life and intelligence (the     ability to learn and understand).      Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF     will be injected under the skin for several days to move stem cells from the bone marrow to     the bloodstream. The stem cells will be collected by apheresis, where blood is drawn through     a needle placed in one arm and pumped into a machine separating and removing the required     cells. The rest of the blood is then returned through a needle in the other arm.      Before the transplant, a central venous line (large plastic tube) is placed into a major     vein. This tube can stay in the body and be used during the entire treatment period to     deliver the donated stem cells, give medications, transfuse blood, if needed, and withdraw     blood samples. Several days before the transplant procedure, patients will begin a     conditioning regimen of low-dose chemotherapy with cyclophosphamide, fludarabine, and Campath     1H. When the conditioning therapy is completed, the stem cells will be infused. To help     prevent rejection of donor cells, cyclosporine will be given by mouth or by vein starting 1     month after the transplant procedure.      The average hospital stay for stem cell transplantation is 21 days. After discharge, patients     will return for follow-up clinic visits weekly or twice weekly for 2 to 3 months. These     visits will include a symptom check, physical examination, and blood tests. Subsequent visits     will be scheduled at 4, 6, 9, and 12 months after the transplant, or more often if required,     and then yearly   "
168301|NCT00031044|"     Even though powerful anti-HIV drug combinations have been successful in patients with little     or no prior anti-HIV therapy, studies have shown that these treatments are less effective in     patients who have been treated with nucleoside analogues. This study will test the safety and     effectiveness of adding one or two new drugs to a personalized anti-HIV regimen for patients     whose previous HIV treatments have failed.   "
168577|NCT00035022|"     The purpose of this study is to determine if intravenous BCX-1777 can be given safely to     improve relapsed or refractory aggressive T-cell leukemias and lymphomas.   "
168306|NCT00031109|"     The purpose of this study is to see if an investigational vaccine can make antibodies     (proteins found in blood) in humans that will influence the course of an AIDS-like disease in     monkeys. Hopefully, the results of this study can be applied to humans.      AIDS, which is caused by infection with HIV, is associated with many deaths and occurrences     of disease. Although recent advances have been made in anti-HIV therapy for AIDS, there is no     cure for HIV infection or AIDS, and drug therapy is too expensive for most infected     populations. Some organizations are trying to make safe and effective vaccines that may     prevent HIV infection and AIDS worldwide. Certain vaccines can generate specific antibodies     in humans, but they do not inhibit HIV infection in laboratory tests. It is possible,     however, that these antibodies may make HIV disease less severe following infection. For this     reason, monkeys will be used to evaluate the role of specific human antibodies.   "
168307|NCT00031122|"     The purpose of this study is to describe the genetic contribution to the neural tube defects     spina bifida (SB) and anencephaly (A), which includes identifying patients, defining the     roles of certain genes, and studying gene-environment interactions.   "
168308|NCT00031135|"     This is a study to determine whether choline, when added to total parenteral nutrition (TPN),     can help prevent the development of hepatic steatosis, a liver disease, in patients on TPN.   "
168309|NCT00031148|"     This is a study to determine the safety and efficacy of keratinocyte growth factor (KGF) to     prevent acute graft-versus-host disease (GVHD) in patients undergoing allogeneic bone marrow     (BM) or peripheral blood progenitor cell (PBPC) transplantation.   "
168310|NCT00031161|"     This is a study to determine the safety of dichloroacetate (DCA) with a low-tyrosine diet     given with or without nitisinone (NTBC) in children with chronic lactic acidosis (CLA).   "
168311|NCT00031174|"     This study will collect white blood cells or plasma (the liquid part of the blood), or both,     from healthy volunteers and from patients with rheumatic or kidney disorders for research     purposes. Rheumatic disorders involve abnormalities of the immune system, the body s defense     against disease. The immune system consists of white blood cells such as lymphocytes and     monocytes, which produce substances such as antibodies and cytokines. White cells and plasma     will be collected through a procedure called apheresis (described below).      Healthy volunteers and patients with confirmed or suspected rheumatic or kidney disease who     are 18 years of age or older may be eligible for this study. Patients must be participating     in a current protocol of the National Institute of Arthritis and Musculoskeletal and Skin     Diseases or the National Institute of Digestive, Diabetes and Kidney Diseases. All candidates     will be screened with a history, physical examination, and blood tests for hepatitis B and C     and HIV infection. Women of childbearing age will be tested for pregnancy. Routine blood     tests will be done in all volunteers, and in patients where needed. Pregnant women and people     who test positive for hepatitis or HIV may not participate.      Participants will undergo apheresis to collect lymphocytes, monocytes, or plasma from the     blood. For this procedure, a needle is placed in a vein in the arm. Blood flows from the vein     through a tube (catheter) into a machine that spins the blood, separating it into its     components. The required cells or plasma are extracted, and the rest of the blood, including     the red cells and platelets, is returned to the body through the same needle or through a     second needle placed in the other arm.      Cells collected from volunteers will be used in studies comparing the number and function of     similar cells from patients with rheumatic diseases, focusing on the differences in number     and function of the cells in health and disease. Components collected from patients will be     used only for studies described in the protocol in which they are currently enrolled.   "
168312|NCT00031187|"     SGN-15 is being investigated for therapy of patients with prostate cancer in combination with     the cytotoxic agent, Taxotere. The study is an open label, randomized phase II study for     patients with documented hormone refractory prostate cancer who have not had any prior     therapy with Taxotere or Novantrone. Both SGN-15 and Taxotere will be administered weekly     over two 6 week courses separated by a 2 week rest period.   "
168313|NCT00031200|"     To investigate the composition and nature of weight loss and weight maintenance during the     Look AHEAD trial. Also, to model changes in resting energy expenditure and changes in cardiac     structure and function associated with weight loss.   "
168314|NCT00031213|"     To evaluate the relationship of baseline toenail chromium concentrations to weight loss, as     well as the interaction between heavy metals and the beneficial effects of weight loss.   "
168315|NCT00031226|"     To determine how weight loss achieved by intensive lifestyle intervention including diet and     exercise alters lipoprotein oxidation/oxidative stress and antioxidant status in overweight     diabetic individuals.   "
168316|NCT00031239|"     To assess the effects of weight loss on sleep disordered breathing in obese, Type 2 diabetics     with obstructive sleep apnea.   "
168317|NCT00031252|"     To test the independent and interrelated effects of the neighborhood social environment, the     neighborhood physical environment, and individual risk factors in predicting all-cause and     cardiovascular disease mortality.   "
168318|NCT00031265|"     The purpose of this trial is to determine if a family intervention administered by telephone     to stroke patients and their caregivers increases adaptation and functioning after stroke.   "
168319|NCT00031278|"     The purpose of this study is to determine if the combination of CPG 7909 and Herceptin is     safe and effective in the treatment of metastatic breast cancer.      RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may     potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety     and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with     metastatic breast cancer who have previously been treated with Herceptin and chemotherapy.      SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.   "
168320|NCT00031291|"     This protocol is a joint project of the National Institutes of Health, the Centers for     Disease Control and the United States Army Medical Research Institute for Infectious     Diseases. It is designed to collect plasma from healthy employees of the Department of     Defense who have been vaccinated against anthrax. The collected plasma will be pooled to make     an anthrax-fighting antibody solution called anthrax immune globulin intravenous (AIGIV).     This solution will be used for:        -  Animal experiments to test its effectiveness in preventing the development of anthrax          after inhalation exposure;        -  Treating people severely ill with anthrax who are not improving with standard antibiotic          therapy; and        -  Treating people exposed to spores of the bacteria that cause anthrax to try to prevent          development of the disease.      Healthy volunteers between 18 and 65 years of age who have received at least four doses of     the anthrax vaccine and who meet the criteria for blood donors may be eligible to participate     in this study. Volunteers will be recruited from Department of Defense civilian and military     employees. Candidates will be screened with an interview and blood tests.      Participants will undergo the following procedures:        -  Have a health history screen for donating plasma        -  Measurement of heart rate, blood pressure and temperature        -  Fingerstick to check hemoglobin level        -  Blood tests for HIV, hepatitis B and C, syphilis and other infectious diseases        -  Blood test for anthrax antibody levels        -  Plasmapheresis to collect blood plasma (the liquid part of the blood)      In plasmapheresis, whole blood is drawn through a needle placed in an arm vein. The blood     flows into a cell separator machine, where it is spun to separate the plasma from the blood     cells. The plasma is collected in a plastic bag in the machine, while the rest of the blood     is returned to the donor through the needle in the arm. During the procedure, the donor is     given a blood thinner called citrate to prevent the blood from clotting while it is in the     cell separator machine. The procedure lasts from 60 to 90 minutes. Only a small fraction of     the body's total plasma is removed, and it is quickly replaced by the body with no long-term     health effects. Participants may be requested to donate plasma as often as every 3 to 4 days     or as infrequently as once a month for a maximum of six donations.   "
168321|NCT00031304|"     Healthy volunteers will be screened under this protocol for possible participation in a study     testing a vaccine against HIV, the virus that causes AIDS.      Healthy adults 18 to 60 years of age may be eligible for this study. Participants must be in     good general health with no history of significant medical problems or abnormal laboratory     test results. Pregnant or breast-feeding women and people infected with HIV will not be     enrolled.      Participants enrolled in this protocol will undergo the following tests and procedures within     8 weeks before the start of the experimental vaccine study:        -  Medical history, including history of sexual activity and drug use        -  Physical examination        -  Pregnancy test for women of childbearing age        -  Blood and urine tests to evaluate possible medical problems such as liver and kidney          function; to evaluate immune function; and to test for HIV, hepatitis and syphilis      Individuals who are identified through this screening protocol as possible candidates for an     HIV vaccine trial will be provided additional information about study options.   "
168322|NCT00031317|"     The purpose of this study is to examine the safety and effectiveness of the drug combination     paroxetine and clonazepam in treating people with panic disorder (PD) and major depression.      The main goal in treating people with PD is to rapidly reduce symptom severity and improve     functioning. While numerous drug therapies have been used to treat PD, these treatments are     limited by variable response rates and suboptimal side effect profiles. Evidence suggests     that clonazepam given with a selective serotonin reuptake inhibitor (SSRI) can facilitate a     rapid reduction in PD symptoms. However, it is unclear whether comorbid depression influences     treatment response to the clonazepam and SSRI regimen. This study will examine whether     combined treatment with clonazepam and the SSRI paroxetine will accelerate clinical response     in participants with PD and comorbid depression. This study will also examine whether the     benefits of treatment will be sustained until the end of the study despite tapering of     clonazepam at the midpoint of the study.      Participants in this study will be screened with medical and psychiatric interviews, a     physical examination, electrocardiogram (ECG), and blood tests. Participants will then be     randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus placebo (an     inactive pill) for 12 weeks. Participants will have weekly clinic visits during which     symptoms and drug side effects will be checked and an interview to evaluate panic disorder     and depression symptoms will be conducted.   "
168323|NCT00031343|"     This study will evaluate how controlling HIV infection with HAART (highly active     antiretroviral therapy) affects the response to hepatitis C treatment with peginterferon     alpha-2b and ribavirin in HIV-infected patients with chronic hepatitis C. HIV worsens liver     disease caused by hepatitis C. Since treatment of HIV infection with HAART improves immune     function, it may be beneficial to start HAART before treating HCV.      HIV-infected patients 18 years of age and older with chronic hepatitis C infection may be     eligible for this study. Patients must have an HCV viral load greater than 2000 copies/mL and     a CD4 count that is either more than 500 cells/mm3, or more than 350 cells/mm3 with an HIV     viral load no greater than 40,000 particles/mL. Candidates will be screened for current or     previous diseases, conditions or treatments that may exclude them from this study. Screening     includes a medical history and physical examination, eye examination, blood and urine tests,     chest X-ray, electrocardiogram (EKG), liver ultrasound, and, possibly, a liver biopsy, if a     recent one is not available. The liver biopsy is optional and is done to determine the     severity of liver disease. Patients will be sedated for this test. The skin in the area over     the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and     out of the liver to obtain a small tissue sample. Patients remain in the hospital overnight     for monitoring. Women of childbearing age will have a pregnancy test.      Patients enrolled in the study will be randomly assigned to one of the following treatment     groups: 1) pegylated interferon and ribavirin for 48 weeks (control group); or 2) HAART for 6     months, followed by 48 weeks of pegylated interferon and ribavirin.      HAART group - Patients taking HAART will be followed in the clinic every 2 weeks for the     first month and then monthly for the next 5 months. After 6 months of HAART they will begin     taking pegylated interferon and ribavirin and will follow the dosing and follow-up schedule     outlined below for patients in the control group.      Control group - Patients will have weekly injections under the skin of peginterferon alpha-2b     and ribavirin pills daily by mouth. Clinic visits will be scheduled as follows:        -  Days 1, 3, 7, and 21 - Blood will be drawn for safety tests and to measure blood levels          of HIV and HCV. HCV medications will be injected on days 7 and 21.        -  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56, and 64 - Blood and urine          tests will be done to determine the side effects of pegylated interferon and ribavirin          treatment and its effect on the HCV infection. Eye examinations will be done every 3          months.        -  Week 48 or end of treatment - Treatment with pegylated interferon and ribavirin will          stop after 48 weeks. At this time (or earlier for those who do not complete the 48 weeks          of treatment), patients will return to the clinic for a routine visit, blood tests          (including a test for hepatitis B) and abdominal ultrasound. Patients may also be          hospitalized for 2 days for a repeat optional liver biopsy.        -  Week 72 and extended follow-up visits - At week 72, patients will return for blood tests          and a routine clinic visit. HCV viral load will be measured. Follow-up visits every 3          months for an additional year will include a blood test to measure HCV viral load and a          complete physical examination.   "
168324|NCT00031369|"     This study will use high-resolution magnetic resonance imaging (MRI) to look for subtle     differences in brain anatomy between patients with focal hand dystonia (also called writer s     cramp) and healthy normal volunteers. Patients with hand dystonia have prolonged muscle     contractions that cause sustained twisting movements and abnormal postures. These abnormal     movements often occur with activities such as writing, typing, playing certain musical     instruments such as guitar or piano, or playing golf or darts.      Patients with focal hand dystonia and healthy volunteers will be enrolled in this study.     Patients will be recruited from NINDS s database of patients with focal hand dystonia.     Volunteers will be selected to match the patients in age, sex and handedness.      This study involves two visits to the NIH Clinical Center. The first visit is a screening     visit, in which patients and volunteers will have a medical history, physical examination,     neurological examination, and assessment of handedness. Women of childbearing age will be     screened with a pregnancy test. Pregnant women are exclude from this study.      Those who join the study will return for a second visit for magnetic resonance imaging. MRI     uses a magnetic field and radio waves to produce images of the brain. For the procedure, the     participant lies still on a stretcher that is moved into the scanner (a narrow cylinder     containing the magnet). Earplugs are worn to muffle loud noises caused by electrical     switching of radio frequency circuits used in the scanning process. The scan will last about     45 to 60 minutes, at most. Some volunteers may be asked to return for a third visit to obtain     a second MRI on a different scanner.   "
168342|NCT00031629|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating     factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in     bone marrow or peripheral blood and may help a person's immune system recover from the side     effects of chemotherapy. This phase II trial is studying how well combination chemotherapy     plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent     cancer of the uterus.   "
173401|NCT00111774|"     The purpose of this study is to determine if ABX-EGF is safe and efficacious in patients with     metastatic colorectal cancer.   "
168325|NCT00031382|"     This study uses magnetic resonance imaging (MRI) to explore the brain activities involved in     performing learned automatic movements. Automatic movements are performed without     concentrating on the details of the movement.      Healthy adult volunteers are eligible for this study. Candidates will have a medical history     and brief physical examination and will fill out a questionnaire. Women of childbearing     potential will have a urine pregnancy test. Pregnant women will not be enrolled.      Participants will perform certain tasks involving movement of the right or left hand while     undergoing MRI scanning. They will undergo scanning twice-before and after practicing the     movement tasks. Before the second scan, participants will practice the following tasks for 1     week:        -  Tapping task - subjects use their left index finger to tap a button at a certain          frequency.        -  Sequential movement task - subjects perform sequential finger-tapping movements with          their right hand, in which they tap buttons with their fingers at a certain frequency in          a 25-second period. There are two sequences of different lengths, referred to as          sequence-4 and sequence-12, based on the number of movements in each unit of the          sequence.        -  Visual distraction task - 14-letter sequences consisting of the letters A, G, L, and O          will be presented and subjects will be asked to identify the number of times they see a          target letter.        -  Dual tasks - after completing all the above tasks, subjects perform the following dual          tasks:      Tapping and visual task      Sequence-4 finger tap and visual task      Sequence-12 finger tap and visual task      Tapping and sequence-4 finger tap      Tapping and sequence-12 finger tap      When the participants can perform the dual tasks correctly 90 percent of the time, the     movements will be considered automatic, and the subjects will undergo MRI scanning. MRI uses     a magnetic field and radio waves to produce images of the brain. For the procedure, the     subject lies still on a stretcher that is moved into the scanner (a narrow cylinder     containing the magnet). Earplugs are worn to muffle loud noises caused by electrical     switching of radio frequency circuits used in the scanning process. The scan will last about     1.5 hours.   "
168326|NCT00031395|"     The purpose of this study is to determine the safety and efficacy of clonidine alone or in     combination with methylphenidate for children 7-12 years of age with attention-deficit,     hyperactivity disorder.   "
168327|NCT00031408|"     The purpose of this study is to obtain informed consent to use stored human biological     materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic     testing.   "
168439|NCT00032981|"     The purpose of this study is to evaluate the therapeutic usefulness of incorporating     Motivational Enhancement Treatment into the standard drug abuse treatment entry process of     Community Treatment Programs on improving treatment engagement, retention, and outcome.   "
168328|NCT00031421|"     The purpose of this study is to document the developments associated with puberty and     determine if any of the children who previously participated in another research study have     been diagnosed with cancer. The previous study was a Collaborative Antiviral Study Group     (CASG) protocol entitled Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic     Congenital Cytomegalovirus Infections. One of the medications used in this study to treat     cytomegalovirus (CMV), ganciclovir, has been known to cause cancer and affect the development     of gonads (ovaries in females and testes in males) when administered to animals. Children,     9-14 years old, who participated in the previous research study, will participate in this     study for 1 day. Subjects will be evaluated by an endocrinologist and will have the following     procedures performed: a complete physical examination, a single blood sample collected, an     x-ray of the left wrist.   "
168329|NCT00031434|"     The purpose of this study is to evaluate how ganciclovir is metabolized when administered     intravenously (by a needle inserted into a vein) following valganciclovir syrup, given by     mouth to newborns and young infants with symptoms of congenital (present at birth)     cytomegalovirus (CMV) disease. The study also seeks to identify a dose of valganciclovir that     provides a comparable blood concentration to ganciclovir present in the blood of newborns     with symptomatic congenital CMV disease. All study participants will receive 6 weeks of     antiviral therapy (defined as ganciclovir and/or valganciclovir). Infants from 0 to 30 days     old will participate in the study for 2 years.   "
168330|NCT00031447|"     The purpose of this study is to test whether long-term treatment with oral acyclovir improves     the outcome for infants with herpes simplex virus (HSV) disease of the skin, eyes, and mouth     (SEM). Study participants will include infants in the United States and Canada who have HSV     disease of the skin, eyes, and mouth, with no central nervous system disease present.     Initially, all subjects will be treated with acyclovir administered through IV access     (through the vein) for 14 days while hospitalized. Participants will then be placed in one of     two groups, acyclovir given by mouth or a placebo (substance with no medication present). The     participant and the study site will not know to which group the subject is assigned. All     children will be followed at 6, 12, 24, 36, 48, and 60 months of age. During the follow up     visits, physicals, hearing assessments, eye assessments, and neurological assessments will be     completed.   "
168331|NCT00031460|"     The purpose of this study is to test whether long term treatment with acyclovir given orally     (by mouth) improves the outcome for infants with herpes simplex virus infection of the brain     or spinal cord (known as the central nervous system [CNS]). Infants with herpes viral     infection of the CNS that has or has not spread to other parts of the body will be enrolled     in this study. All participants will receive treatment in a hospital for 21 days with     acyclovir, given intravenously (by a needle inserted into a vein). Participants will then be     divided into two groups: those with CNS disease that has or has not spread to the skin, and     those whose viral infection has spread and involves the CNS. Both groups will be randomly     assigned to receive either oral acyclovir or placebo (inactive substance) for 6 months.     Infants in the US and Canada will participate for 5 years. A physical exam, hearing exam, eye     exam, and an evaluation of the nervous system will be performed throughout the study.   "
168332|NCT00031473|"     The purpose of this study is to test the safety and effectiveness of ribavirin, administered     as an aerosol, in preventing progression of upper respiratory tract RSV infection to RSV     pneumonia in bone marrow and peripheral blood transplant recipients.   "
168333|NCT00031486|"     This study involves patients 12 years and older who have been diagnosed with herpes simplex     encephalitis (HSE) by a specific laboratory test and have completed treatment or are being     treated with intravenous (given through a needle inserted into a vein) acyclovir. The purpose     of the study is to determine if treatment with 4 tablets, 500 milligrams each, of     valacyclovir given 3 times daily by mouth for 90 days is both effective and safe after     completing intravenous acyclovir treatment and if it can increase survival with or without     mild impairment of the brain and mental functions. Participants will be assigned to either     drug or placebo (inactive substance) randomly (by chance). Study procedures will include     blood samples and lumbar punctures (procedure in which a needle is inserted into the lower     back to collect cerebral spinal fluid). Subjects will participate for up to 24 months.   "
168343|NCT00031642|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver     cancer-killing substances to them without harming normal cells. Radiolabeled monoclonal     antibodies can locate and deliver radioactive cancer-killing substances.      PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal     antibodies with rituximab in treating patients who have non-Hodgkin's lymphoma that has not     responded to high-dose chemotherapy and autologous stem cell transplantation.   "
173442|NCT00112021|"     This is a study to examine the effect of pramlintide on body weight and its safety and     tolerability in obese subjects.   "
168334|NCT00031499|"     The purpose of this study is to determine if azithromycin, a drug approved for treatment of     other infections, is as effective for syphilis (a sexually transmitted disease) as the     standard treatment. Approximately 600 healthy adults, who are HIV-negative, ages 18 to 55     years of age, with primary, secondary or early latent syphilis, will participate in this     research study. Volunteers will be enrolled in 5 U.S. cities and in Madagascar. Participants     will be chosen randomly (by chance) to receive 1 of 2 study drugs: benzathine penicillin     given (2 shots in the buttocks) or 4 tablets of azithromycin. Subjects who report a history     of a penicillin allergy will be given either 2.0 g of oral azithromycin or 100 mg doxycycline     taken orally, twice a day for 14 days. Over 2 years, 10 visits will be required. Procedures     will include blood samples, physical exams, and swabs of sores.   "
168358|NCT00031837|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may     help prevent blood clots in patients being treated with gemcitabine for unresectable or     metastatic pancreatic cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or     without dalteparin in treating patients who have unresectable or metastatic pancreatic     cancer.   "
168361|NCT00031876|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to determine the effectiveness of combining capecitabine and     paclitaxel in treating patients who have metastatic breast cancer.   "
168335|NCT00031512|"     A common group of viruses that infect humans are enteroviruses. Enteroviruses produce     illnesses in children which may range from very mild (summer colds) to severe (infections of     the brain, liver, and heart). The purpose of this study is to determine if a new drug called     pleconaril helps treat babies with enteroviral sepsis. In addition, researchers are     attempting to determine a safe and effective dose of pleconaril to help babies with this     disease. Infants who are 15 days or younger when diagnosed with enteroviral disease are     eligible for this study. Two out of 3 babies will be randomly assigned to receive Pleconaril     and the other one out of three will receive a placebo (inactive substitute). Participants     will be hospitalized while receiving study medication. Babies will receive standard treatment     care for their symptoms and will be observed for their medical progress. Participants may be     in the study for up to 2 years.   "
168336|NCT00031538|"     This study will analyze tissue and blood samples from patients with gliomas (a type of brain     tumor) to develop a new classification system for these tumors. Tumor classification can help     guide treatment, in part by predicting how aggressive a tumor may be. Gliomas are currently     classified according to their grade (how quickly they may grow) and the type of cells they     are composed of. This system, however, is not always accurate, and sometimes two tumors that     appear to be identical under the microscope will have very different growth patterns and     responses to treatment. The new classification system is based on tumor genes and proteins,     and may be used in the future to better predict a given tumor s behavior and response to     therapy.      Patients with evidence of a primary brain tumor and patients with a known glioma who will be     undergoing surgery to remove the tumor may participate in this study.      A sample of tumor tissue removed in the course of a participant s normal clinical care will     be used in this study for laboratory analysis of genes and chromosome abnormalities. A small     blood sample will also be collected for genetic analysis. In addition, clinical information     on patients condition and response to treatment will be collected every 6 months over several     years. This information will include findings from physical and neurologic examinations,     radiographic findings, and response to therapy, including surgery, radiation and     chemotherapy.   "
168337|NCT00031551|"     This study consisted of two parts: the pilot study and the main study. The purpose of the     pilot study is to demonstrate the effectiveness of planned laboratory techniques to assess     for TNF-alpha gene expression from unstimulated saliva, plasma, and mucosal epithelial cells     in patients who have chemotherapy-related stomatitis.      Main Study Description: Stomatitis is defined as inflammation of the mucous membranes of the     oral cavity and oropharynx characterized by tissue erythema, edema, and atrophy, often     progressing to ulceration. Stomatitis is a biologically complex, multifactorial, cancer     treatment-related oral condition experienced by many oncology patients, which often leads to     a cascade of negative sequelae including oropharyngeal pain, critical treatment alterations     or cessation, and decreased quality of life. The optimal treatment strategies for stomatitis     have not been established. There is a critical need to examine the pathogenesis of and to     evaluate interventions for stomatitis and related acute oropharyngeal pain in the randomized     controlled clinical trial setting using valid and reliable stomatitis assessment tools to     both advance the science of cancer treatment-related oral toxicities and improve patient     care. Therefore, the purpose of this randomized controlled clinical trial is to elucidate the     role of inflammation in stomatitis by testing the effects of a novel tumor necrosis factor     (TNF) fusion protein etanercept, (Enbrel, Immunex Corporation, Seattle, WA) on the incidence     and severity of stomatitis. The actions of this fusion protein, which binds specifically to     TNF preventing its interaction with cellular receptors and altering the inflammatory cascade,     may provide insight into the role of inflammation in stomatitis. An etanercept effect is     defined as a prevention or amelioration of stomatitis and acute oropharyngeal pain and/or     changes in levels of tissue mediators. If stomatitis is primarily a consequence of a mucosal     inflammatory response, then we hypothesize that this oral condition will be responsive to     binding of TNF(alpha). Elaboration of the role of inflammatory cell signaling associated with     stomatitis and the effect of TNF(alpha) may elucidate the mechanisms related to the     pathogenesis of stomatitis and to other mucosal conditions.      Patients who are scheduled to receive autologous or allogenic peripheral blood stem cell or     bone marrow transplant will be invited to participate in this study during a regularly     scheduled pre-treatment visit. Written informed consent will be obtained from all     participants. Patients will be randomized to receive either etanercept mouthwash or placebo,     which will both be administered by protocol schedule. Stomatitis and oropharyngeal pain will     be measured at baseline and at specified post-chemotherapy time points corresponding with the     predicted stomatitis onset, peak, and healing time course. TNF(alpha) levels in buccal     mucosa, analyzed by reverse transcriptase polymerase chain reaction techniques, and blood     levels of pro-inflammatory cytokines, growth factors, and inflammatory mediators will also be     measured at baseline and at specified post-chemotherapy time points corresponding with the     predicted stomatitis onset, peak, and healing time course.   "
168338|NCT00031564|"     RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells     may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a     person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2     may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with     interleukin-2 in treating patients who have stage IV kidney cancer.   "
168339|NCT00031577|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Paclitaxel may make the tumor cells more sensitive to radiation therapy.      PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel with radiation     therapy in treating children who have newly diagnosed brain stem glioma.   "
168340|NCT00031590|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or     die. Combining low-dose radiation therapy with combination chemotherapy may be effective in     treating primitive neuroectodermal tumor and medulloblastoma.      PURPOSE: This phase II trial is studying giving low-dose radiation therapy together with     combination chemotherapy after surgery to see how well it works in treating children with     newly diagnosed primitive neuroectodermal tumor or medulloblastoma.   "
168341|NCT00031616|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of NB1011 in treating patients who have     metastatic or recurrent colorectal cancer that has not responded to previous treatment.   "
168568|NCT00034879|"     A program for patients with non small cell lung cancer who may benefit from Iressa, but     cannot enter another clinical trial due to them not being eligible, or for whom no trials are     available.   "
168359|NCT00031850|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of raloxifene and goserelin may be effective in     preventing breast cancer.      PURPOSE: Randomized pilot study to study the effectiveness of combining raloxifene and     goserelin in preventing breast cancer in women who have a family history of breast cancer.   "
168360|NCT00031863|"     RATIONALE: Rofecoxib may stop the growth of cancer by stopping blood flow to the tumor and     killing tumor cells that remain after surgery. It is not yet known if rofecoxib is effective     in treating colorectal cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of giving rofecoxib after     surgery in treating patients who have stage II or stage III colorectal cancer.   "
168344|NCT00031655|"     The reason for doing this study is to determine whether a new method of blood stem cell     transplant (also known as bone marrow transplant) is able to treat acute lymphocytic     leukemia. Blood stem cells are the seed cells necessary to make all blood cells. This new     method of transplant uses a combination of low dose radiation and chemotherapy that may be     less toxic and cause less harm than a conventional transplant. This lower dose transplant is     called a nonmyeloablative transplant. Researchers want to see if using less radiation and     less chemotherapy combined with new immune suppressing drugs after the transplant will help a     stem cell transplant to work. Researchers hope that this treatment will cure acute     lymphocytic leukemia with fewer side effects. Researchers are hoping to see a mixture of     recipient and donor blood cells after transplant. This mixture of donor and recipient blood     cells is called mixed chimerism. Researchers hope that donor cells will attack and     eliminate the leukemia. This is called the graft-versus-leukemia effect. In addition, after     the transplant, white blood cells from the donor may be given to enhance or boost the     graft-versus-leukemia effect, and hopefully remove all remaining cancer cells. This study is     being done because at the present time blood stem cell transplantation (or bone marrow     transplantation) is the only known curative therapy for acute lymphocytic leukemia. Because     of age or underlying health status acute lymphocytic leukemia patients have a higher     likelihood of experiencing severe harm from a conventional blood stem cell transplant.     Researchers are doing this study to see if this new nonmyeloablative method of low dose     radiation and low dose chemotherapy given before transplant and immune suppressive drugs     after transplant will help make the transplant safer and also cure acute lymphocytic leukemia   "
168345|NCT00031668|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known if giving radiation therapy after stem cell transplantation is more effective than stem     cell transplantation alone in treating relapsed or refractory non-Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in     treating patients who have relapsed or refractory non-Hodgkin's lymphoma and have undergone     autologous stem cell transplantation.   "
168346|NCT00031681|"     This phase I trial is studying the side effects and best dose of giving     7-hydroxystaurosporine together with irinotecan hydrochloride in treating patients with     metastatic or unresectable solid tumors, including triple-negative breast cancer (currently     enrolling only patients with triple-negative breast cancer since 6/8/2007). Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Giving 7-hydroxystaurosporine together with irinotecan hydrochloride may help kill more     cancer cells by making tumor cells more sensitive to the drug.   "
168347|NCT00031694|"     Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in     treating patients who have locally advanced unresectable or metastatic pancreatic cancer.     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells     more sensitive to the drug.   "
168348|NCT00031707|"     RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may     improve cancer-related weight loss and lack of appetite. It is not yet known whether     megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a     combination of both is most effective in treating cancer-related weight loss and loss of     appetite.      PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without     an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty     acid-enriched nutritional supplement alone in treating patients who have cancer-related     weight loss and lack of appetite.   "
168349|NCT00031720|"     RATIONALE: Soy protein supplement may be effective in reducing hot flushes in postmenopausal     women who are receiving tamoxifen for breast disease.      PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement     in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast     disease such as ductal hyperplasia or breast cancer.   "
168350|NCT00031733|"     RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining     vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor     cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy     with interleukin-12 and either alum or sargramostim in treating patients who have undergone     surgery for stage II, stage III, or stage IV melanoma.   "
168351|NCT00031746|"     RATIONALE: Soy protein supplement may prevent or delay the development of prostate cancer in     patients who have elevated prostate-specific antigen (PSA) levels.      PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement     in preventing prostate cancer in patients who have elevated PSA levels.   "
168352|NCT00031759|"     RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the     development of cancer. Applying topical imiquimod before abnormal cervical cells are removed     may be effective in preventing cervical cancer.      PURPOSE: Randomized phase II trial to study the effectiveness of applying topical imiquimod     before abnormal cervical cells are removed in preventing cervical cancer in patients who have     recurrent or persistent cervical neoplasia.   "
168353|NCT00031772|"     RATIONALE: Telephone counseling by breast cancer survivors may enhance the well-being and     quality of life of women who have recurrent breast cancer.      PURPOSE: Randomized clinical trial to study the effectiveness of telephone counseling by     breast cancer survivors on the well-being of women who have recurrent breast cancer.   "
168354|NCT00031785|"     RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in     limiting weight loss in patients who are undergoing radiation therapy.      PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting     weight loss in patients who are undergoing radiation therapy for lung cancer.   "
168355|NCT00031798|"     RATIONALE: Methylphenidate may decrease side effects of radiation therapy. It is not yet     known if methylphenidate is effective in improving quality of life in patients with primary     or metastatic brain tumors.      PURPOSE: Randomized phase III trial to determine the effectiveness of methylphenidate in     improving quality of life in patients who have brain tumors and are undergoing radiation     therapy.   "
168356|NCT00031811|"     RATIONALE: Raloxifene and exercise may improve bone health and quality of life in breast     cancer survivors. Assessing bone health and quality of life may improve the ability to plan     treatment.      PURPOSE: Randomized clinical trial to study the effectiveness of raloxifene with or without     exercise compared with exercise alone in women who have been previously treated for breast     cancer.   "
168357|NCT00031824|"     RATIONALE: Hydroxychloroquine may decrease the immune response and be effective in treating     chronic graft-versus-host disease. It is not yet known if standard therapy for     graft-versus-host disease is more effective with or without hydroxychloroquine.      PURPOSE: Randomized phase III trial to compare the effectiveness of standard therapy alone     with that of standard therapy plus hydroxychloroquine in treating patients who have newly     diagnosed chronic graft-versus-host disease.   "
168434|NCT00032916|"     The purpose of this study is to conduct a drug interaction study with NS2359 and cocaine in     cocaine experienced volunteers.   "
168362|NCT00031889|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using     exemestane plus bicalutamide may fight prostate cancer by reducing the production of     androgens. It is not yet known if exemestane is more effective with or without bicalutamide     in treating prostate cancer.      PURPOSE: Randomized phase II trial to study the effectiveness of exemestane with or without     bicalutamide in treating patients who have stage IV prostate cancer that has been previously     treated with hormone therapy or surgery.   "
168363|NCT00031902|"     RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Combining rituximab with chemotherapy may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy     in treating patients who have HIV-related non-Hodgkin's lymphoma.   "
168364|NCT00031915|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes     necessary for cancer cell growth.      PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients     who have metastatic or unresectable locally advanced soft tissue sarcoma or bone sarcoma.   "
168365|NCT00031928|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who     have progressive or refractory meningeal tumors.   "
168366|NCT00031941|"     RATIONALE: CC-5013 may stop the growth of cancer by stopping blood flow to the tumor.      PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have     solid tumors and/or lymphoma that did not respond to previous therapy.   "
168367|NCT00031954|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian     tube, or peritoneal cancer that has not been previously treated.   "
168368|NCT00031967|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     melatonin may make tumor cells more sensitive to radiation therapy and may protect normal     cells from the side effects of radiation therapy.      PURPOSE: Randomized phase II trial to determine the effectiveness of combining melatonin with     radiation therapy in treating patients who have brain metastases.   "
168369|NCT00031980|"     RATIONALE: Cyclosporine may improve low blood counts caused by hematologic cancer.      PURPOSE: Phase II trial to study the effectiveness of cyclosporine in treating patients who     have low blood counts caused by hematologic cancer.   "
168370|NCT00031993|"     This phase II trial is studying erlotinib to see how well it works in treating patients with     persistent or recurrent cancer of the cervix. Biological therapies such as erlotinib may     interfere with the growth of tumor cells and slow the growth of the tumor   "
168371|NCT00032006|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as     goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing     androgens. Internal radiation uses radioactive material placed directly into or near a tumor     to kill tumor cells. Combining hormone therapy with internal radiation may be effective in     treating locally recurrent prostate cancer.      PURPOSE: Phase II trial to study the effectiveness of hormone therapy followed by internal     radiation in treating patients who have locally recurrent prostate cancer following     external-beam radiation therapy.   "
168372|NCT00032019|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. Combining rituximab with combination chemotherapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination     chemotherapy in treating patients who have previously untreated non-Hodgkin's lymphoma.   "
168373|NCT00032032|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy and radiation therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation     therapy when given with combination chemotherapy and to see how well they work in treating     patients with non-small cell lung cancer that cannot be surgically removed.   "
168419|NCT00032708|"     A double-blind, randomized, dose-response study of four dilutions of Dryvax in previously     vaccinated adults in order to assess the clinical success rates, humoral responses, and     virus-specific actifity of cytotoxi T cells and interferon-y producing T cells   "
168374|NCT00032045|"     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill     tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Combining vaccine therapy with     a monoclonal antibody may cause a stronger immune response and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with     monoclonal antibody therapy in treating patients who have stage IV melanoma.   "
168375|NCT00032058|"     RATIONALE: Imaging procedures such as magnetic resonance imaging (MRI) and magnetic resonance     spectroscopic imaging (MRSI) may improve the ability to detect the extent of prostate cancer.     It is not yet known if MRI combined with MRSI is more effective than MRI alone in detecting     the extent of prostate cancer.      PURPOSE: Diagnostic trial to compare the effectiveness of combining MRI with MRSI to that of     MRI alone in determining the extent of prostate cancer in patients who are scheduled to     undergo surgery to remove the prostate gland.   "
168376|NCT00032084|"     RATIONALE: A program that includes bupropion may be more effective in helping early-stage     lung cancer patients to quit smoking. It is not yet known if a program to quit smoking is     more effective with or without bupropion.      PURPOSE: Randomized phase III trial to determine the effectiveness of a program to quit     smoking with or without bupropion in treating patients who have undergone surgery for stage I     or stage II non-small cell lung cancer.   "
168377|NCT00032097|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     motexafin gadolinium may make the tumor cells more sensitive to radiation therapy.      PURPOSE: Phase I trial to study the effectiveness motexafin gadolinium in treating patients     with glioblastoma multiforme who are undergoing radiation therapy to the brain.   "
168378|NCT00032110|"     Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow     the growth of the tumor. Phase II trial to study the effectiveness of erlotinib in treating     patients who have recurrent or metastatic colorectal cancer.   "
168379|NCT00032123|"     RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor     cells and slow the growth of the tumor.      PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have     locally advanced or metastatic stomach cancer or cancer of the gastroesophageal junction.   "
168380|NCT00032136|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     exemestane may fight breast cancer by reducing the production of estrogen. It is not yet     known if exemestane is more effective than tamoxifen in preventing the recurrence of breast     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of exemestane with that of     tamoxifen in treating postmenopausal women who have undergone surgery to remove early-stage     breast cancer.   "
168381|NCT00032149|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.     Colony-stimulating factors such as filgrastim may increase the number of immune cells found     in bone marrow or peripheral blood and may help a person's immune system recover from the     side effects of chemotherapy.      PURPOSE: Phase I/II trial to study the effectiveness of combining filgrastim with combination     chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.   "
168382|NCT00032162|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining liposomal doxorubicin with     carboplatin in treating patients who have gynecologic cancer.   "
168383|NCT00032175|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if gemcitabine is more effective with or     without capecitabine in treating pancreatic cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or     without capecitabine in treating patients who have locally advanced or metastatic pancreatic     cancer.   "
168384|NCT00032188|"     Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining bryostatin 1 with interleukin-2 may cause a stronger immune response and kill     more tumor cells. Randomized phase II trial to study the effectiveness of combining     interleukin-2 and bryostatin 1 in treating patients who have advanced kidney cancer   "
168385|NCT00032201|"     Background:        -  Many risk factors for breast cancer have been identified, including family history,          endocrine background, changes in breast tissue, cancer in one breast, radiation          exposure, obesity and others. There is a spectrum of tissue changes seen in cancerous          and pre-cancerous breast tissue.        -  A cell line is a collection of cells that are grown in the laboratory from an original          tissue specimen. Cell lines developed from high-risk breast tissue allow researchers to          perform metabolic and molecular studies of breast cells over time.      Objective: To establish a repository (facility in which tissue samples can be preserved and     stored for many years) of cell lines from high-risk breast tissue to allow researchers to     learn more about changes in breast cells that may cause them to develop into breast cancer.      Eligibility: Women between 20 and 80 years of age who:        -  Have an increased risk of breast cancer because they are members of a high-risk breast          or ovarian cancer family.        -  Have had breast cancer in one or both breasts.        -  Have had radiation for lymphoma before the age of 30.        -  Have a mutation in a breast cancer susceptibility gene, but whose family history is not          known.        -  Are not at increased risk of breast cancer.      Design:        -  A small piece of breast tissue will be obtained from about 10 women without an          identified risk of breast cancer and up to 100 women at high risk of developing breast          cancer.        -  Cell lines will be developed from each high-risk category.        -  The cell lines and tissues will be used to establish a repository of high-risk breast          cell lines and breast tissues that can be used to study how the cells develop into          breast cancer.   "
168420|NCT00032721|"     This study will investigate the use of Reiki, an energy-based complementary and alternative     medicine (CAM) intervention, as an approach to improve well-being for patients with advanced     AIDS, and evaluate its effects on dimensions of well-being and quality of life.   "
168386|NCT00032227|"     The Carpal Tunnel Syndrome Diagnosis and Treatment Trial is project #1 of the     Multidisciplinary Clinical Research Center focused on upper extremity pain. It is a     randomized trial comparing surgical and nonsurgical treatments for patients with early, mild     to moderate carpal tunnel syndrome. In addition the study will evaluate the ability of a new     magnetic resonance (MR) technique at predicting who will likely benefit from carpal tunnel     syndrome (CTS) surgery.   "
168387|NCT00032240|"     This trial will test shoe inserts for the treatment of knee osteoarthritis, the most common     form of knee arthritis. Those with disease on the inner (medial) aspect of the knee will be     studied.   "
168388|NCT00032279|"     The purpose of this phase II study is to evaluate an investigational monoclonal antibody for     the treatment of glucocorticoid-refractory Graft Versus Host Disease (GVHD). Patients     diagnosed with GVHD who have not responded satisfactorily to, or are intolerant of, treatment     with standard agents will be considered for entry. Patients will be allowed to continue on     their other immunosuppressive drugs at stable doses during the trial. The research is being     conducted at up to 20 clinical research sites in the US.   "
168389|NCT00032292|"     The purpose of this Phase I/II, open-label, dose-escalation study is to evaluate an     investigational monoclonal antibody administered as a first-line therapy to patients with     acute, Grade II, III, or IV graft-versus-host disease (GVHD). Patients will be eligible for     enrollment within 24 hours of beginning standard steroid treatment. The research is being     conducted at up to 10 clinical research sites in the US.   "
168390|NCT00032305|"     The purpose of the study is to evaluate an intravenous (by injection) investigational     medication to treat severe ulcerative colitis refractory to steroid therapy. The research is     being conducted at up to 8 clinical research sites in the US and is open to both men and     women ages 18 to 70 years old. Participants in the study will have a number of visits to a     research site. All study-related care and medication is provided to qualified participants at     no cost: this includes all visits, examinations and laboratory work.   "
168391|NCT00032331|"     All patients with a new, untreated solitary pulmonary nodule (SPN) between 7 mm and 3 cm in     diameter identified by chest x-ray, will be approached to undergo positron emission     tomography (PET) and computerized tomography (CT). The PET and CT scans will be interpreted     independently.      The Primary Care Physician will be provided the results of the baseline chest x-ray and the     CT scan, and will be asked for a management and treatment decision. Then the results of the     PET will be provided to the Primary Care Physician who will be asked for a management and     treatment decision based on all findings (chest x-ray, CT, and PET).   "
168392|NCT00032344|"     Colorectal cancer is a leading cause of cancer death in the United States. Mortality remains     high because most colorectal cancers are detected after there has been regional or distant     spread, precluding curative surgical resection. With this in mind, screening strategies have     been recommended for asymptomatic individuals which hope to reduce mortality from colon     cancer by detecting and removing premalignant adenomatous polyps or early malignant lesions.     Screening of asymptomatic individuals over age 50 with sigmoidoscopy and fecal occult blood     tests has been advocated by the American Cancer Society. However, current screening will     identify only 50% of patients who have adenomatous polyps. More sensitive tests for polyp     detection, like colonoscopy, are costly, require extensive resources and are unlikely to be     used for screening large populations. Ideal screening would identify patients with the     highest risk of cancer and target more sensitive screening tests at this population. The     identification of low cost, easily collectible risk factors which can be used to target     patients for the more sensitive screening tests is the primary purpose of this study. Since a     major segment of the veteran population is over the age of 50, there will be a substantial     impact in reduction of both mortality and morbidity due to colon cancer and attendant cost     savings to the VA for treatment if such risk factors can be identified.      Phase I is a cross-sectional study designed to identify risk factors for large (>1 cm)     adenomatous polyps. Approximately 3200 asymptomatic subjects (age 50-75) have completed risk     factor assessment, medical and dietary histories, and have undergone complete colonoscopy     examination. This will identify for comparison purposes a polyp-free control group and is the     first large prospective study to include such a group. Data at colonoscopy will characterize     the prevalence, size and distribution of adenomatous polyps. This will permit an assessment     of sensitivity of sigmoidoscopy in this population. In addition, tissue from normal rectal     mucosa will be analyzed for evidence of cell proliferation activity. The primary focus of     Phase I is a risk factor analysis. A multivariate analysis will be performed to determine the     relationship of historical and environmental factors as well as cell proliferation activity     with the presence of adenomatous polyps. A cohort consisting of a subgroup of polyp patients     (large and small) and matched polyp-free controls will be tracked longitudinally to determine     polyp occurrence/recurrence rates.      Phase II of the study is a long-term follow-up study designed to evaluate the relative risk     of two repeat colonoscopies.      Phase III is an extension in follow-up of an additional five years, a total of ten years in     all, to include all study patients. The primary focus will be on documenting long-term     mortality and medical outcomes as well as occurrence/reoccurrence of neoplasia with special     emphasis on ten-year cancer rates.   "
168393|NCT00032357|"     Veterans Affairs Cooperative Study #410, The Iron and Atherosclerosis Trial, FeAST, a     24-hospital prospective randomized single-blinded clinical trial of graded iron reduction was     conducted between May 1, 1999 and April 30, 2005, and has now been completed. A total of     1,277 primarily male participants with peripheral arterial disease were entered. The primary     outcome was all cause mortality and the secondary outcome combined death plus non-fatal     myocardial infarction (MI) and stroke.   "
168394|NCT00032370|"     Although a number of sophisticated diagnostic tests have been shown to be helpful in     identifying patients at high risk for perioperative cardiac complications, no study has     addressed the most important question: Should prophylactic coronary revascularization be     performed prior to elective vascular surgery? This study is designed to answer this question.   "
168395|NCT00032383|"     The purpose of this study is to determine the relative merits of vestibular rehabilitation     and Tai Chi for patients with inner ear (vestibular) disorders.   "
168396|NCT00032396|"     A study evaluating Retisert in patients with age-related macular degeneration   "
168397|NCT00032409|"     The purpose of this study is to determine the effects of music therapy-based relaxation     stress/reduction strategies on the frequency/severity of toxic side-effects of marrow     ablative chemotherapy and the timing of immune reconstitution in patients undergoing bone     marrow/stem cell transplantation.   "
168398|NCT00032422|"     The purpose of this study is to determine if acupuncture decreases adrenaline levels in heart     failure, thereby potentially improving survival and quality of life.   "
168399|NCT00032435|"     The primary objective of this study is to test the hypothesis that administration of folate,     pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with     advanced chronic renal failure or end stage renal disease and abnormally high plasma     homocysteine levels will lower the homocysteine levels and the death rate compared to     patients who receive placebo. The secondary objective is to test the hypothesis that intake     of the vitamins compared to placebo decreases the incidence of myocardial infarction,     disabling stroke, and amputation of a lower extremity and, in hemodialysis patients,     thrombosis of the vascular access.   "
168400|NCT00032448|"     Inguinal hernia is one of the most common worldwide afflictions of men. The presence of an     inguinal hernia is indication for its repair. Approximately 700,000 hernia repairs are     performed in the U.S. each year, and this procedure accounts for 10% of all general surgery     procedures in the Veterans Health Administration (VHA) (10,000 inguinal herniorrhaphies     performed per year). There are many different techniques currently in use for repairing     inguinal hernias and with the advent of laparoscopy, yet another technique is being     advocated. Laparoscopic repair has been reported in some studies to be superior to open     repair because of less pain and earlier return to work. However, laparoscopic repair requires     a general or regional anesthetic and expensive equipment and supplies to perform. There is     also evidence that open tension-free mesh repair may have results similar to laparoscopic     repair for these patient centered outcome measures. The general acceptance of this procedure,     especially in the VHA, has not been uniform. Furthermore, no randomized trial of sufficient     size and power to be conclusive has been done to set forth the operative gold standard for     hernia repair.   "
168401|NCT00032461|"     Primary Hypothesis: Gulf War veterans will have an equal prevalence or mean level of the     following medical and psychological conditions frequently reported in the literature compared     to a control group of nondeployed veterans: (1) chronic fatigue syndrome, (2) fibromyalgia,     (3) post-traumatic stress disorder, (4) neurologic abnormalities, including peripheral     neuropathy and cognitive dysfunction, and (5) general health status.   "
168435|NCT00032929|"     The purpose of this study is to evaluate the Selegiline Transdermal System for the treatment     of cocaine dependence.   "
168402|NCT00032474|"     The purpose of this study is to examine whether the ingestion of the herbal dietary     supplement Ginkgo biloba extract has any effect on the efficacy of three classes of diabetic     medications - (Glucotrol, Glucophage and Actose). Additionally, the study will examine the     effect of Ginkgo biloba extract on pancreatic insulin production in non-diabetic subjects     between the ages of 20 and 75 years old.   "
168403|NCT00032487|"     This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic     control, achieved through intensification of treatment, is effective in preventing clinical     macrovascular complications in patients with type 2 DM who are no longer responsive to oral     agents alone. The study consists of a two-year accrual period and five years of follow-up (7     years total) of 1700 patients across 20 centers. We have powered the study to detect a 21%     reduction in the primary event rate. Additional study goals are to determine whether the     expenditures, discomfort, and adverse effects associated with intensive intervention are     justified in terms of their clinical benefits, considering both macrovascular and     microvascular complications.   "
168404|NCT00032500|"     The purpose of this study is to determine whether three Echinacea preparations with different     chemical compositions are effective for prevention or treatment of the common cold.   "
168405|NCT00032513|"     Epstein-Barr virus (EBV) is a member of the human herpes virus family that infects more than     95 percent of the U.S. population. Most infections occur in childhood and cause no symptoms;     in adolescents and adults, EBV often causes infectious mononucleosis. It has also been     associated with certain forms of cancer. Chronic Epstein-Barr virus (CAEBV) is a rare     disease, primarily of children and young adults, that leads to life-threatening infections.      This study seeks to identify genetic mutations responsible for CAEBV. A secondary goal is to     learn more about the natural history of CAEBV.      The study will examine blood and tissue samples from up to 50 patients (age 2 and above) with     CAEBV and up to 150 of their relatives (age 2 and above). Autopsy samples may be included in     the study. Up to 300 anonymous blood samples from the NIH Clinical Center Blood Transfusion     Medicine will also be examined for comparison.      No more than 450 milligrams (30 tablespoons) of blood per 8 weeks will be drawn from adult     patients, and no more than 7 milliliters per kilogram of blood per 8 weeks will be drawn from     patients under age 18. Local health care providers will refer patients to the study and will     obtain the samples. Some patients may also be seen at the NIH Clinical Center. Those patients     will have a full medical history and physical examination, along with chest X-ray, blood     counts, blood chemistry, EBV serologies, and viral load. Other tests, such as CT scan or MRI,     may be performed if medically indicated. Patients will be asked to undergo leukapheresis.      In vitro tests on the blood or tissue samples will include analysis for proteins or genes     that are involved in the immune response; cloning of portions of patient DNA; transformation     of B cells with EBV; measurement of the ability of patient blood cells to kill EBV-infected     cells; determination of lymphocyte subsets; and determination of antibodies to EBV or other     herpes viruses.      If a genetic cause for CAEBV is found, the investigators will be available to discuss the     results with patients in person or by telephone. Genetic indications of risk for other     diseases will also be discussed with patients.   "
168406|NCT00032526|"     Most clinicians who care for patients with inflammatory airway diseases such as allergic     rhinitis and asthma are aware of the negative effects of certain sights, sounds and smells     that can precipitate clinical exacerbations in certain susceptible patients. This is thought     to be due to subconscious associations between these observable stimuli paired and actual     exposure to allergens that induce clinical symptoms. The severity and duration of these     symptoms are typically related to levels of anxiety and/or depression in affected patients.     Classical conditioning of the immune response has been described in many animal and some     human studies in association with administration of immunosuppressive drugs. In successfully     conditioned individuals, subsequent exposure to the conditioning stimulus alone produces     immunosuppressive changes similar to those caused by the drugs themselves. Since disease     exacerbating conditioning appears to be prevalent in allergic patients, these conditions make     an excellent human model for understanding the relationships between classical conditioning,     psychological stress (particularly anxiety and depression) and immune regulation. Thus this     proposal will seek to examine the hypothesis that antiinflammatory effects of     pharmacotherapeutic agents can be classically conditioned and are clinically effective due to     changes in immunoregulatory imbalances known to occur in patients with allergic airway     diseases. The effectiveness of this therapeutic approach will be significantly affected by     levels of psychological stress and individual suggestibility. This will be investigated with     the following Specific Aims: (1). Determine the relative effectiveness of classical     conditioning by a novel gustatory stimulus paired with immunosuppressive doses of     corticosteroid on in vivo and in vitro immune responses (allergen - specific vs. general) of     patients before, during and after classical conditioning correlated with level of clinical     response; (2) Determine the role of neuroendocrine mechanisms (particularly catecholamines)     on the inducibility and duration of the conditioned immune responses; and (3) Investigate the     influence of psychological stress levels (including anxiety and depression) and/or     suggestibility on baseline immune changes, success and duration of the classical     conditioning.      These data will help define parameters for classical conditioning in humans, establish a     model to investigate mechanisms and serve as the basis for development of future     interventional protocols for severe inflammatory diseases involving classical conditioning.   "
168407|NCT00032539|"     Patients in 'parent' cooperative study projects are interviewed about their experiences in     the informed consent process.   "
168408|NCT00032552|"     Patients in 'parent' cooperative studies projects are interviewed about their experiences in     the informed consent process.   "
168409|NCT00032565|"     Patients in 'parent' cooperative studies projects are interviewed about their experiences in     the informed consent process.   "
168421|NCT00032734|"     The study is designed to assess the efficacy of an investigational drug called SR121463B     (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood     associated with the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).      This double blind period study is followed by 2 open label extension studies with flexible     doses of satavaptan.   "
168422|NCT00032747|"     This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration     study. Randomization will be stratified according to the patient's baseline serum sodium     concentration (137-144 and <137 mmol/L). The dose of study drug will be increased to the next     level on Day 15, and the total duration of the double-blind treatment period is 120 days.   "
168410|NCT00032578|"     This project is a program-wide genetic tissue databank for the Department of Veterans Affairs     Cooperative Studies Program (CSP). The genetic tissue bank has four components: a central     repository for DNA and other genetic tissue specimens; a Scientific Advisory Committee of     individuals with expertise in the genetics and epidemiology of diseases with special     importance to the VA (including cardiovascular, neurologic, respiratory, psychological and     other disorders); an Ethics Oversight Committee of individuals with expertise in bioethics     and the law, as they apply to the collection and use of genetic tissue, and a Coordinating     Center that administers the tissue bank, coordinates the scientific and ethics oversight     committees, maintains central access to clinical study data linked to the tissue bank, and     provides statistical analysis.   "
168411|NCT00032591|"     Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and     convenience of chronic anticoagulation management, it is likely that there will be demands     from providers, patients, and manufacturers to make home monitors available to VA patients.     The rationale for patient self-testing (PST) is that, compared to conventional high quality     anticoagulation management (HQACM), it would permit more intense monitoring and increased     patient participation in his/her own care, resulting in increased precision in     anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The     secondary hypothesis is that PST and HQACM will be comparable in terms of health care     utilization and cost.   "
168412|NCT00032617|"     The purpose of the proposed DVA cooperative study is to evaluate the efficacy of exposure     therapy for treating PTSD and associated problems in female veterans and active duty military     personnel. We propose to compare exposure therapy, Prolonged Exposure, with a comparison     therapy that focuses on current problems, Present Centered Therapy.      The study is a randomized clinical trial involving 384 female veterans and active duty     personnel in 11 VA medical centers and 1 DoD medical center. All subjects, even     self-referrals, will enter the study through referrals by mental health clinicians at the     participating sites. Following informed consent, subjects will be screened for inclusion and     exclusion diagnoses. If they meet these criteria and agree to participate, they will be     randomly assigned to one of the two treatments, which will occur weekly for 10 weeks.     Subjects will be assessed before treatment, immediately following treatment, and 3 and 6     months after the end of treatment. The primary outcome is PTSD severity. Secondary outcomes     are anxiety and depression. Exploratory outcomes include associated features of PTSD, such as     dissociation and substance abuse; psychosocial functioning, quality of life, physical health,     satisfaction with treatment, and service utilization. Both treatments will be described in     detail in a treatment manual and monitored intensively to ensure that they are administered     correctly.   "
168413|NCT00032630|"     Ischemic heart disease is one of the most frequent diagnoses in the VA system. Moreover,     5,819 coronary artery bypass graft (CABG-only) procedures were performed in the VA in Fiscal     Year (FY) 1999. Throughout VA and non-VA cardiac surgery programs nationwide, myocardial     revascularization is now being performed using two surgical techniques. One technique is     performed with cardiopulmonary bypass (CPB) usually with cardioplegic arrest (on-pump) and     the other without CPB on a beating heart (off-pump). The overall purpose of this proposed     randomized, controlled, clinical trial is to rigorously evaluate the impact of using an     on-pump versus off-pump surgical technique for coronary artery bypass graft (CABG-only)     procedures (performed with a traditional median sternotomy incision) upon patient clinical     outcomes and resource utilization.   "
168414|NCT00032643|"     Congestive heart failure (CHF) affects 4-5 million Americans, and its prevalence is predicted     to increase over the next few decades. Thyroid hormone has unique actions which make it a     novel and potentially useful agent for treatment of CHF. Due to possible adverse affects of     thyroid hormone, there is interest in developing analogs with fewer undesirable side effects.     3,5- diiodothyropropionic acid (DITPA) has been shown to improve diastolic function in both     animal models and a recently completed double-blind placebo controlled trial in 19 humans.      The goal of the proposed Phase II study is to show safety and demonstrate a medication of     efficacy of DITPA needed in patients with CHF. This study is a prerequisite for a larger     Phase III trial which would determine whether mortality is improved with DITPA. To better     define the appropriate doses, prior to the Phase II study we will conduct an initial     pharmacokinetic study.   "
168415|NCT00032656|"     The purpose of this study is to help improve our understanding of when and why adolescents     decide to use alternative and complimentary medicines, and to understand factors that lead to     better communication between youth and their clinicians.   "
168416|NCT00032669|"     This study will evaluate a new treatment strategy called therapeutic drug monitoring (TDM) in     HIV-infected children and adolescents. TDM involves analyzing the virus, giving drugs the     virus is most sensitive to, monitoring drug blood levels to make sure there is enough drug to     work against the virus, and changing the drug dose if it is too low.      HIV-infected children between 0 and 21 years of age who may benefit from treatment with a     protease inhibitor and who are not benefiting from their current antiretroviral drug     treatment regimen may be enrolled in this 48-week study. Patients who are not currently     receiving antiretroviral treatment, including patients who have never received antiretroviral     treatment, may be enrolled in the study.      Participants will have blood drawn to learn what anti-HIV drugs the patient's virus is     resistant to-that is, what drugs are no longer effective against the virus. This is     determined by analyzing the virus's genotype (detailed genetic structure) and phenotype     (response to exposure to anti-viral drugs). Based on these test results and the patient's     prior medication history, a drug regimen tailored to the individual patient will be     prescribed. It may include one or two nucleoside reverse transcriptase inhibitors, such as     zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse     transcriptase inhibitor such as nevirapine or efavirenz, and a protease inhibitor such as     amprenavir, nelfinavir, saquinavir, ritonavir, or Kaletra (a combination of lopinavir and     ritonavir).      After the patients begin treatment, the amount of the protease inhibitor in the blood will be     measured. If not enough of the drug is found in the blood, the dose of the drug will be     increased and the amount of the drug in the blood will be checked again. In this study, the     dose may be increased up to three times.      Patients will be seen in clinic for 6 days when treatment begins to measure blood levels of     the medicines and evaluate the response of the virus. Treatment will then continue on an     outpatient basis. Drug levels will be measured periodically throughout the study. The viral     load will also be measured and additional tests to determine whether the resistance pattern     of the patients' virus has changed. In addition, patients will undergo the following tests     and procedures at various times throughout the study, more frequently for the first few     months and then less often:        -  Blood tests to measure cell counts and viral load        -  Routine laboratory tests to measure kidney, liver, bone marrow, and other organ          functioning        -  Eye and neuropsychologic examinations        -  Echocardiogram (heart ultrasound)        -  Electrocardiogram (EKG - heart rhythm test)        -  Chest X-ray        -  Computed tomography (CT) scan of the head        -  Skin tests      To make sure the medicines work, they must be taken as directed. In addition, since higher     than usual doses of some of the anti-HIV drugs may be given, it will be important to know     whether the patients are taking all of the medicine that has been prescribed. This study will     therefore also measure patients' adherence to their medication regimen in two ways: 1) some     medicines will be packaged in a bottle with an electronic medicine bottle cap that will     record when the bottle is opened, and 2) patients and their parents will be interviewed by     phone or in person at various times during the study about adherence and may be asked to fill     out forms that record the number of doses taken. This will allow the doctor and patient to     work together to make sure the medicines are being taken properly. Patients and parents will     also be interviewed periodically about their understanding of HIV disease, about social     supports that are available, and about the child's emotional adjustment.   "
168417|NCT00032682|"     This study will evaluate a questionnaire for measuring constipation in children with cancer.     The questionnaire used in this study (Constipation Assessment Scale) reliably predicts the     presence and severity of constipation in adult patients, but has not been tested in children.     The answers to the questionnaire will be used to determine the child's level of constipation     and to plan and provide appropriate care.      Patients up to 21 years of age who are enrolled in National Cancer Institute trials and are     taking weekly vinca alkaloids or narcotics twice a day or more may be eligible for this     study.      On admission to the study, participants will undergo the following procedures:        -  The child (or the child's parent) will be interviewed about the child's bowel habits.        -  The results of the child's most recent physical examination related to bowel function          will be obtained from the medical record for review.        -  A registered dietitian will interview the child or parent about the child's eating          habits.      During the study, participants will undergo the following procedures:        -  A registered nurse will interview the child or parent about the child's bowel movements.          This will be done every other day for hospitalized children and three times a week (by          phone) for outpatients.        -  The child or parent will complete a daily diary of bowel movements.        -  A registered dietitian will evaluate the child's nutritional status periodically (by          phone).      Children who are not constipated when they enter the study will receive a stool softener     every day to prevent constipation. Children who become constipated during the study will be     treated as needed. Patients will be followed for 7 days after the last dose of vinca alkaloid     or narcotic for a maximum of 6 weeks.   "
168418|NCT00032695|"     The purpose of this study is to determine whether methionine, an amino acid present in low     doses in the normal diet, can improve myelopathy or stop its progression.   "
168424|NCT00032773|"     To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to     identify the minimal effective dose of pentostatin defined as the lowest dose that produces a     response in 20% or more of patients while producing treatment failure (defines as death,     grade 3/4 toxicity, or progressive disease) in 40% or less of patients.   "
168425|NCT00032786|"     The purpose of this study is to determine the safety and efficacy of natalizumab in     individuals diagnosed with moderate to severely active Crohn's disease. It is thought that     natalizumab may stop the movement of certain cells, known as white blood cells, into bowel     tissue. These cells are thought to cause damage in the bowel leading to the symptoms of     Crohn's disease.   "
168426|NCT00032799|"     The purpose of this study is to determine the safety and efficacy of natalizumab in     individuals diagnosed with moderately to severely active Crohn's disease. It is thought that     natalizumab may stop the movement of certain cells, known as white blood cells, into bowel     tissue. These cells are thought to cause damage in the bowel leading to the symptoms of     Crohn's disease.   "
168427|NCT00032812|"     This study will examine and compare what happens in the brains of patients with Parkinson's     disease with that of healthy normal subjects while they train to react as fast as possible to     the appearance of a visual signal. Particularly, we will measure the amount of the chemical     dopamine released in the brain as well as the electrical activity during training. Indeed,     patients with Parkinson's disease frequently complain of slowness and early fatigue during     movements. These symptoms are believed to be related to a decrease of dopamine in the brain     which may be associated with abnormalities in cerebral electrical activity.      Adult patients with Parkinson's disease who are right-handed, do not have dementia, and are     not depressed may be eligible for this study. Healthy volunteers who match patients in age,     gender, handedness, and level of education will also be studied. Candidates will be screened     with a medical history, physical and neurological examinations, memory test, mood evaluation,     and urine toxicology.      All participants will be required to stop taking any medications that can influence the     central nervous system and to abstain from alcohol consumption for 1 week before the     screening examination and during the study training period. Patients with Parkinson's disease     will also be required to stop using antiparkinsonian medications for at least 12 hours before     the first visit and each training session.      Participants will have several 1-hour training sessions. During these sessions, they will sit     facing a computer screen at a distance of about 32 inches (80 centimeters) from their eyes.     Six permanent position markers will be displayed. A keyboard with six spatially compatible     response keys will be within reach of their right hand. Participants will respond as quickly     and as accurately as possible to the appearance of a stimulus (e.g., white circle) below one     of the markers by pressing the spatially corresponding key. About a second later, the next     stimulus will be displayed below one of the other markers, and so on. Reaction times and     accuracy will be recorded. After 3 to 10 minutes of practice (one block), there will be a     rest period during which the computer will display information about the subject's accuracy     of movements and reaction time. Then, a new block will start. There will be about 6 to 20     practice blocks per training session. The number of training session will vary between 3 and     6 depending on accuracy and reaction time during the task.      During each training session, subjects will have encephalographic (EEG) recordings to measure     the electrical activity of the brain. In addition, they will have one or two positron     emission tomography (PET) scans during the first training session, and some will also have     one or two PET scans during the last session. For the PET scan, the subject will be injected     with a substance called raclopride, which is taken up by the brain. The raclopride is tagged     with a radioactive substance so that it can be detected by the PET camera. The amount of     raclopride detected in the brain will provide an indirect measure of the amount of dopamine     released during training.      Before or after one of the training sessions, participants will undergo magnetic resonance     imaging (MRI) to study brain anatomy. MRI uses a strong magnetic field and radio waves to     produce images of the brain. The subject lies on a table in a space enclosed by a metal     cylinder (the scanner). The test takes about 45 to 60 minutes, during which the participant     must lie very still for 10 to 15 minutes at a time.   "
168436|NCT00032942|"     The purpose of this study is to evaluate lofexidine for opiate withdrawal.   "
168437|NCT00032955|"     The purpose of this study is to assess buprenorphine/naloxone versus clonidine for inpatient     opiate detoxification.   "
168438|NCT00032968|"     The purpose of this study is to assess buprenorphine/naloxone versus clonidine for outpatient     opiate detoxification.   "
168428|NCT00032825|"     This study will determine the maximum dose of docetaxel that can be given safely in     combination with ketoconazole for treating advanced prostate cancer. Docetaxel is approved     for the treatment of several other types of cancers; ketoconazole is an approved antifungal     medication that is also commonly used in high doses to treat prostate cancer.      Patients 18 years of age and older with advanced prostate cancer that does not respond to     hormone therapy may be eligible for this study. Candidates will be screened with blood tests     to evaluate liver, kidney and other organ function and with x-rays, scans, or other imaging     tests to determine the extent of disease.      Participants will take the following medications:        -  Docetaxel daily, infused through a vein over 30 minutes, in 4-week cycles-3 consecutive          weeks of drug followed by one week of rest        -  Dexamethasone, 12 hours and 1 hour before and 12 hours after docetaxel infusions to help          prevent fluid retention caused by the docetaxel        -  Ketoconazole, 3 times a day        -  Hydrocortisone, twice a day to replace a loss of natural steroids caused by the          ketoconazole      Patients will be hospitalized 1 to 2 days each for the first and second doses of docetaxel to     allow for frequent blood draws to measure blood levels of the drug. Ketoconazole will be     started about 2 weeks after the first dose of docetaxel and the second dose of docetaxel will     be given 2 days after that. In order to determine the maximum tolerated dose of docetaxel,     the first few patients in the study will be given a low dose of the drug, and subsequent     patients will get increasingly higher doses until unacceptable side effects occur. Because     prostate cancer cells may grow if exposed to testosterone, patients may have to have their     testosterone production suppressed either surgically (removal of the testicles) or medically     with an injection of leuprolide or goserelin, which are luteinizing hormone-release hormone     agonists that reduce the amount of testosterone.      Imaging studies, such as x-rays, bone scans or computed tomography (CT) scans, will be done     about every 3 months to examine how the tumor is responding to therapy. After six treatment     cycles, patients will have monthly chest x-rays to check for fluid around the lining of the     lungs, which may occur as a result of docetaxel therapy.      Treatment is expected to continue for at least 3 to 6 months, although this time could be     shortened or extended depending on the tumor response to therapy or side effects of the     drugs. Patients who do not experience bad side effects and whose tumor does not grow during     the first 3 treatment cycles will continue treatment; those who experience unacceptable side     effects will be taken off the study.   "
168429|NCT00032838|"     The purpose of this study is to examine how hormonal changes that occur during stressful     situations affect thought and emotions. Results from this study may lead to treatments that     can alleviate the psychological effects of trauma.      Levels of cortisol and norepinephrine increase in response to stress; these hormones also     influence thought processes. This study will give hydrocortisone and/or yohimbine (a     stimulator of central norepinephrine) to healthy adults in order to model the stress response     and to better understand the way people process information during traumatic events.      This study comprises two experiments in which the stress response is pharmacologically     modeled. Participants in the study will have two study visits. During Visit 1, participants     will undergo a psychiatric assessment, complete neuropsychological tasks, and have their IQ     measured. During Visit 2, participants will be given hydrocortisone and/or yohimbine. Blood     will be collected before and during this. Participants will then perform two experiments. In     one experiment, participants will hear a story with emotional and non-emotional segments; in     a second experiment, participants will view both emotional and non-emotional stimuli.   "
168430|NCT00032864|"     A Seattle VA study indicated lower extremity ulcers preceded 84% of diabetic amputations.     Nearly half of the events that ban the causal chain leading to ulcers and amputation were     initiated by ill-fitting footwear. Other investigators report similar findings for injurious     footwear in their diabetic patient populations. Yet, the efficacy of footwear in preventing     ulcers and amputations in the high-risk diabetic population has received limited experimental     investigation. A British descriptive study followed diabetic patients with healed foot ulcers     for two years and found reulceration occurred in 72% of patients who resume wearing their own     footwear compared to 26% of patients who continued wearing prescribed footwear. A Swedish     cohort study identified individuals with a foot ulcer and reported their 1, 3, and 5 year     reulceration rates at 34%, 61%, and 70%, respectively, without further specifying footwear     components. In a German diabetic population the reulceration rate was 87% in-patients who     abandoned their custom shoes and resumed wearing their own shoes compared to 42% of those who     continued to wear their custom shoes. Unfortunately, none of these studies compared the     single or combined contribution of therapeutic shoes or insoles on foot ulcer prevention. Nor     did these studies address patient adherence to prescribed footwear; thus the actual efficacy     of various footwear interventions in foot ulcer prevention in this high-risk population is     still to be tested.   "
168431|NCT00032877|"     This study will examine blood or other tissue samples from patients with Fraser syndrome and     patients with Fryns syndrome to try to identify the gene responsible for these diseases.     Fraser syndrome is characterized by congenital abnormalities including cryptophthalmos (lack     of eyelid formation), syndactyly (webbed fingers or toes) and abnormal genitalia. Patients     may also have abnormalities of the nose, ears and larynx (voice box), cleft lip or palate,     and kidney agenesis. Fryns syndrome is characterized by hernia through the diaphragm, cloudy     cornea, coarse facial features, cleft lip or palate, abnormal fingers and toes, heart, kidney     and brain malformations and hydrocephalus (accumulation of fluid around the brain). This     protocol consists of laboratory study only; it does not involve patient care or patient     counseling.      Patients with Fraser syndrome or Fryns syndrome are eligible for this study. Parents and     healthy siblings of patients will also be included for genetic study, and parents of children     with undiagnosed multiple congenital anomalies syndromes will be included for comparison     study.      Participants will provide a blood sample (about 8 to 10 teaspoons from adults; 1 to 3     teaspoons from children) or sample of skin cells collected by swabbing the inner surface of     the cheek. Some patients may undergo a skin biopsy, in which a small skin sample (about     1/8-inch in diameter) is surgically removed. The tissue samples will be used to obtain DNA     (genetic material) for laboratory testing. A permanent cell line-a collection of cells grown     in the laboratory from the original tissue specimen-will also be established to enable     additional testing in the future.   "
168432|NCT00032890|"     This study will determine whether glucosamine, chondroitin sulfate and/or the combination of     glucosamine and chondroitin sulfate are more effective than placebo and whether the     combination is more effective than glucosamine or chondroitin sulfate alone in the treatment     of knee pain associated with osteoarthritis (OA) of the knee after six months of follow-up.     These substances, marketed in the United States as dietary supplements, have been widely     touted by the lay press and by anecdotal personal experience as effective in treating OA. To     date, however, only a few small studies have been published in the worldwide literature. The     study proposed herein has been carefully constructed to definitively determine the efficacy     of these agents.   "
168433|NCT00032903|"     Gimatecan® is Sigma-Tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this     class play a crucial role in destroying DNA replication in tumors. We are conducting this     study to determine the Maximum Tolerated Dose of our compound. In addition, we plan to assess     the drug's ability to affect the evolution of malignant gliomas, when given as a capsule,     rather than by intravenous injection.   "
168451|NCT00033137|"     This study will investigate the genetic cause of Birt Hogg-Dube (BHD) syndrome and the     relationship of this disorder to kidney cancer. BHD is a rare inherited condition     characterized by papules, or bumps benign tumors involving hair follicles on the head and     neck. People with BHD are at increased risk of developing kidney cancer. Scientists have     identified the chromosome (strand of genetic material in the cell nucleus) that contains the     BHD gene and the region of the gene on the chromosome. This study will try to learn more     about:        -  The characteristics and type of kidney tumors associated with BHD        -  The risk of kidney cancer in people with BHD        -  Whether more than one gene causes BHD        -  The genetic mutations (changes) responsible for BHD      Patients with known or suspected Birt Hogg-Dube syndrome, and their family members, may be     eligible for this study. Candidates will be screened with a family history and review of     medical records, including pathology reports for tumors, and films of computed tomography     (CT) and magnetic resonance imaging (MRI) scans.      Participants may undergo various tests and procedures, including the following:        -  Physical examination        -  Review of personal and family history with a cancer doctor, cancer nurses, kidney          surgeon, and genetic counselor        -  Chest and other x-rays        -  Ultrasound (imaging study using sound waves)        -  MRI (imaging study using radiowaves and a magnetic field)        -  CT scans of the chest and abdomen (imaging studies using radiation)        -  Blood tests for blood chemistries and genetic testing        -  Skin evaluation, including a skin biopsy (surgical removal of a small skin tissue sample          for microscopic evaluation)        -  Cheek swab or mouthwash to collect cells for genetic analysis        -  Lung function studies        -  Medical photography of skin lesions      These tests will be done on an outpatient basis in either one day or over 3 to 4 days. When     the studies are complete, participants will receive counseling about the findings and     recommendations. Patients with kidney lesions may be asked to return periodically, such as     every 3 to 36 months, based on their individual condition, to document the rate of     progression of the lesions.   "
168465|NCT00033319|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of aspirin and/or folic acid may be effective in     preventing recurrent polyps in patients who have had polyps removed previously.      PURPOSE: Randomized clinical trial to determine the effectiveness of aspirin and/or folic     acid in preventing the recurrence of colorectal polyps.   "
168466|NCT00033332|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow     to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not     yet known whether dexamethasone is more effective with or without thalidomide in treating     multiple myeloma.      PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or     without thalidomide in treating patients who have multiple myeloma.   "
168467|NCT00033345|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Indole-3-carbinol may be effective in preventing breast     cancer.      PURPOSE: Phase I trial to study the effectiveness of indole-3-carbinol in preventing breast     cancer in nonsmoking women who are at high risk for breast cancer.   "
168452|NCT00033150|"     Brief Summary:      Nearly 7% of elementary school children present with difficulties learning and using     language. Unfortunately, language impairments are often long lasting and may have serious     social, academic, and vocational ramifications. More than 1 million children receive language     intervention in the public schools each year, and many more are seen in hospitals and other     clinical settings.      This randomized clinical trial compares the language outcomes of Fast ForWord to two other     interventions (computer assisted language intervention without acoustically modified speech     and individual language intervention) and to the outcomes of an academic enrichment (control)     condition. Each year for 3 years, children will be randomly assigned to each of the four     conditions at three regional sites (Austin, Texas, Dallas, Texas, and Lawrence, Kansas). The     treatments will be administered in special summer programs. The primary research question is     which intervention results in the most improvement in the composite language score from the     Oral and Written Language Scales. Secondary questions include which intervention results in     the greatest gains in conversational language,which intervention results in the greatest     gains 3 and 6 months after training, which intervention results in the greatest improvement     in auditory perception, and which intervention is the most cost effective.      The results of the study will have theoretical and practical value. Theoretically, the study     tests the temporal processing hypothesis of language impairment. Practically, the study will     describe and compare the language, communication, auditory processing and academic outcomes     of different language interventions. The study will help clinicians and administrators choose     the most effective and least expensive treatment for the children they serve.   "
168453|NCT00033163|"     Control of hepatitis B virus (HBV) infection can be difficult in HIV infected people who have     taken the antiviral lamivudine (3TC). These people may have HBV that has become resistant to     3TC. Adefovir dipivoxil (ADV) has shown promising anti-HBV activity in clinical trials;     tenofovir disoproxil fumarate (TDF) is used to treat HIV and may also be effective against     HBV. The purpose of this study is to find out if adding ADV or TDF to a highly active     antiretroviral therapy (HAART) regimen that includes 3TC has an effect on HBV infection in     patients coinfected with HIV and HBV. The tolerability and safety of these drugs will be     examined.   "
168454|NCT00033176|"     The purpose of this study is to determine the immunomodulatory and antiviral effects of the     glutathione-restoring dithiol, alpha lipoic acid (ALA) in HIV-infected persons unresponsive     to highly active antiretroviral treatment (HAART).   "
168455|NCT00033189|"     This study will help to determine the safety and efficacy of the nutritional supplement     Coenzyme Q10 when added to steroids as a treatment for Duchenne muscular dystrophy (DMD).     Boys with DMD who are enrolled in this study will should be on a stable dose of steroids for     at least six months, and will remain on their usual dose throughout the study. They will     complete two screening visits within a one-week period, and if enrolled will then have their     strength tested monthly for three months before beginning therapy with Coenzyme Q10. Once     Coenzyme Q10 therapy is started, participants will have their strength tested monthly for six     months. Following the six month treatment period, participants will be given the option to     remain on Coenzyme Q10 until the study is completed.   "
168456|NCT00033202|"     Gimatecan® is sigma-tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this     class play a crucial role in destroying DNA replication in tumors. We are conducting this     study to determine the Maximum Tolerated Dose of our compound, when given as a capsule,     rather than by intravenous injection.   "
168457|NCT00033215|"     To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy     accessible cancer who have failed previous therapy or to whom no standard therapies are     available. To determine the pharmacokinetic profile of S-3304 in this patient population   "
179282|NCT00194948|"     This study will determine the effectiveness of offering primary care patients their preferred     treatment versus one that is less desirable in improving treatment adherence and outcome.   "
168458|NCT00033228|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing     the vaccine directly into a lymph node may cause a stronger immune response and kill more     tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients     who have stage IV melanoma.   "
168459|NCT00033241|"     RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the     tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining erlotinib with gemcitabine may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with gemcitabine in     treating patients who have newly diagnosed locally advanced or metastatic pancreatic cancer     or other solid tumors.   "
168460|NCT00033254|"     Randomized phase III trial to compare the effectiveness of radiation therapy with or without     thalidomide in treating patients who have brain metastases. Radiation therapy uses     high-energy x-rays to damage tumor cells. Drugs such as thalidomide may stop the growth of     brain metastases by stopping blood flow to the tumor. It is not yet known whether radiation     therapy is more effective with or without thalidomide in treating brain metastases.   "
168461|NCT00033267|"     Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle     cell non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer     cells from dividing so they stop growing or die.   "
168462|NCT00033280|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy and radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation     therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed     anaplastic oligoastrocytomas.   "
168463|NCT00033293|"     This randomized phase III trial is studying cyclophosphamide, prednisone, and immunoglobulin     to see how well they work compared to cyclophosphamide and prednisone alone in treating     patients with abnormal eye and trunk muscle movements (known as opsoclonus myoclonus ataxia)     associated with neuroblastoma. Drugs used in chemotherapy work in different ways to stop     tumor cells from dividing so they stop growing or die. Steroid therapy decreases     inflammation. Combining chemotherapy and steroid therapy with immunoglobulin may be effective     in treating abnormal muscle movement associated with neuroblastoma.     Chemotherapy(cyclophosphamide), prednisone and intravenous gamma globulin all suppress the     immune system which may be helpful in treating opsoclonus-myoclonus-ataxia (OMA).   "
168468|NCT00033358|"     Randomized phase II trial to compare two different hormone therapy regimens in preventing     endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon cancer.     Hormone therapy may prevent the development of endometrial cancer in women with a genetic     risk for hereditary nonpolyposis colon cancer. It is not yet known which hormone therapy     regimen is more effective in preventing endometrial cancer.   "
168469|NCT00033371|"     This randomized phase II trial studies how well giving celecoxib with or without eflornithine     works in preventing colorectal cancer in patients with familial adenomatous polyposis.     Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib     and eflornithine may keep cancer from forming in patients with familial adenomatous     polyposis.   "
168470|NCT00033384|"     RATIONALE: CI-1040 may stop the growth of tumors by blocking the enzymes necessary for cancer     cell growth and by stopping blood flow to the tumor.      PURPOSE: Phase II trial to study the effectiveness of CI-1040 in treating patients who have     metastatic or unresectable breast, colon, pancreatic, or non-small cell lung cancer.   "
168471|NCT00033397|"     RATIONALE: Comparing results of diagnostic procedures performed before, during, and after     chemotherapy may help doctors predict a patient's response to treatment and help plan the     most effective treatment.      PURPOSE: Diagnostic trial to study magnetic resonance imaging (MRI) and biomarkers in women     who are receiving chemotherapy before surgery for locally advanced breast cancer.   "
168472|NCT00033410|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Tirapazamine may make the tumor cells more sensitive to radiation therapy. Combining     chemotherapy, radiation therapy, and tirapazamine may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with tirapazamine     and radiation therapy in treating patients who have stage II or stage III non-small cell lung     cancer.   "
168473|NCT00033423|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in     treating patients who have relapsed or refractory non-Hodgkin's lymphoma.   "
168474|NCT00033436|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     carbogen and niacinamide may make tumor cells more sensitive to radiation therapy. It is not     yet known whether radiation therapy is more effective with or without carbogen and     niacinamide in treating patients who have bladder cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or     without carbogen and niacinamide in treating patients who have locally advanced bladder     cancer.   "
168475|NCT00033449|"     This phase I trial is studying the side effects and best dose of gefitinib when given     together with radiation therapy with or without cisplatin in treating patients with stage III     or stage IV head and neck cancer. Biological therapies such as gefitinib may interfere with     the growth of tumor cells and slow the growth of cancer. Radiation therapy uses high-energy     x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die. Combining gefitinib and radiation therapy     with cisplatin may kill more tumor cells   "
168476|NCT00033462|"     Phase II trial to study the effectiveness of erlotinib in treating patients who have     unresectable liver, bile duct, or gallbladder cancer. Biological therapies such as erlotinib     may interfere with the growth of cancer cells and slow the growth of the tumor.   "
168505|NCT00033904|"     Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected,     locally advanced renal cell carcinoma have improved recurrence-free survival as compared to     subjects with no adjuvant treatment.   "
168477|NCT00033475|"     RATIONALE: Some types of lymphoproliferative disease are associated with Epstein-Barr virus.     Combining reduced immunosuppressive therapy with donor white blood cells that have been     treated in the laboratory to kill cells infected with Epstein-Barr virus may be an effective     treatment for lymphoproliferative disease.      PURPOSE: Randomized phase III trial to compare the effectiveness of reducing     immunosuppressive therapy with or without donor white blood cells in treating patients who     have Epstein-Barr virus-associated lymphoproliferative disease after organ transplantation.   "
168478|NCT00033488|"     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective     treatment for ovarian cancer.      PURPOSE: Screening trial to determine the best procedure to detect ovarian cancer in women     who have a high genetic risk for developing ovarian cancer.   "
168479|NCT00033514|"     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Biological     therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth     of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as     first-line therapy in treating women who have metastatic breast cancer associated with     HER2/neu overexpression.   "
168480|NCT00033527|"     RATIONALE: INS316 may produce a better sputum sample for laboratory analysis and may provide     a less invasive method of diagnosing lung cancer.      PURPOSE: Randomized diagnostic trial to compare the effectiveness of INS316 with that of     saline for sputum collection in diagnosing lung cancer in patients suspected of having lung     cancer.   "
168481|NCT00033540|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, use different     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one     drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine     in treating patients who have locally advanced or metastatic gallbladder cancer or     cholangiocarcinoma.   "
168482|NCT00033553|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan     treatment may result in more effective radiation therapy. It is not yet known which     chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell     lung cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of different combination     chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have     unresectable stage III non-small cell lung cancer.   "
168484|NCT00033592|"     RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop     smoking and prevent them from starting smoking again. It is not yet known whether a nicotine     inhaler or bupropion are more effective alone or combined for stopping smoking.      PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or     bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to     stop smoking and prevent starting smoking again.   "
168485|NCT00033605|"     RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who     are undergoing radiation therapy to the pelvis. It is not yet known whether octreotide is     effective for diarrhea.      PURPOSE: Randomized phase III trial to determine the effectiveness of octreotide in     preventing diarrhea in patients who are undergoing radiation therapy to the pelvis.   "
168486|NCT00033618|"     Randomized phase II trial to study the effectiveness of ixabepilone in treating patients who     have metastatic or recurrent head and neck cancer. Drugs used in chemotherapy use different     ways to stop tumor cells from dividing so they stop growing or die   "
168487|NCT00033631|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet     known which dose of radiation therapy is more effective in treating stage II prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of     specialized radiation therapy in treating patients who have stage II prostate cancer.   "
168488|NCT00033644|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Colony-stimulating factors such as sargramostim may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus     sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the     uterus.   "
168489|NCT00033657|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining radiation therapy with chemotherapy before and after surgery may kill more     tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of combining radiation     therapy with two different chemotherapy regimens before and after surgery in treating     patients who have esophageal cancer.   "
168490|NCT00033683|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving them after surgery may kill     any tumor cells remaining after surgery. It is not yet known which combination chemotherapy     regimen is more effective in treating resected stage I or stage II breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination     chemotherapy regimens in treating women who have resected stage I or stage II breast cancer.   "
168491|NCT00033696|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy and radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation     therapy in treating patients who have limited-stage small cell lung cancer.   "
168506|NCT00034034|"     This study investigates the effect of acupuncture in reducing symptom distress in adults with     advanced colon cancer.   "
168507|NCT00034047|"     This 36-week study will determine whether traditional Chinese medicine (acupuncture and     Chinese herbs) is as effective as hormone therapy for alleviating endometriosis-related     pelvic pain.   "
168492|NCT00033709|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to     the tumor. Combining temozolomide with thalidomide may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with thalidomide     in treating patients who have metastatic, locally advanced, or unresectable leiomyosarcoma.   "
168493|NCT00033722|"     RATIONALE: Lometrexol may stop or slow the growth of tumor cells by blocking the enzymes     necessary for tumor cell growth. Folic acid may be effective in preventing or lessening the     side effects of lometrexol. Combining lometrexol with folic acid may be an effective     treatment for non-small cell lung cancer.      PURPOSE: Phase II trial to study the effectiveness of combining lometrexol with folic acid in     treating patients who have stage IIIB or stage IV non-small cell lung cancer that has been     previously treated.   "
168494|NCT00033735|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether irofulven is effective in treating     pancreatic cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of irofulven with that of     fluorouracil in treating patients who have locally advanced or metastatic pancreatic cancer     that has not responded to previous treatment with gemcitabine.   "
168495|NCT00033748|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients     who have colorectal cancer that has spread to the liver.   "
168496|NCT00033774|"     This study will examine the development of stem cells (very immature cells produced by the     bone marrow) and their potential to change into cells of other organ types. These cells will     be studied for their potential use in creating replacement tissue for diseases ranging from     diabetes to Parkinson s.      Healthy volunteers 18 years of age or older may be eligible for this study. Candidates will     be screened with a medical history, physical examination, and blood tests.      Participants will undergo a process called 'stem cell mobilization and apheresis' to collect     bone marrow stem cells. For five days before the collection they will receive injections of a     hormone called G-CSF, which stimulates release of stem cells from the bone marrow into the     bloodstream. On the fifth day of the injections, stem cells will be collected through     apheresis. For this procedure, blood is collected through a catheter (plastic tube) placed in     an arm vein and directed into a cell separator machine. There, the white cells and stem cells     are separated from the other blood components through a spinning process and collected in a     bag inside the machine. The rest of the blood is returned to the donor through a catheter in     the other arm.   "
168569|NCT00034892|"     The purpose of this study is to compare the effectiveness, tolerability, and efficacy of the     currently available atypical antipsychotic drugs olanzapine (2.5-20 mg/day), quetiapine     (100-800 mg/day) and risperidone (0.5-4 mg/day) in patients with schizophrenia,     schizophreniform disorder, or schizoaffective disorder who are experiencing their first     psychotic episode.   "
168497|NCT00033787|"     Serotonin is a chemical involved in regulation of emotions, anxiety, sleep, stress hormones,     and other body functions. The purpose of this study is to use a procedure called tryptophan     depletion to study the function of serotonin in people with depression and in healthy     volunteers.      Major depressive disorder (MDD) has been associated with reduced functioning of central     serotonergic systems. Tryptophan depletion (TD) is a procedure used to investigate the     relationship between serotonergic function and depression. Evidence suggests that the mood     lowering effects of TD depend upon family history and differences in genes for a specific     protein called 5-HTTLPR. Healthy females with a particular gene for 5-HTTLPR and a family     history of mood disorders appear to be at a greater risk for the development of depressive     symptoms during TD. This study will use positron emission tomography (PET) scans of the brain     to investigate the effect of variant 5-HTTLPR genotypes on response to TD. The relationship     between 5-HTTLPR genotypes and the effect of TD on brain activity in individuals with     different 5-HTTLPR genes will be determined. This study will also examine how the reduced     serotonin function that occurs in MDD affects the brain's response to sensory stimulation.      Participants in this study will be screened by telephone about their psychiatric and medical     history, current emotional state, anxiety and sleep patterns, and family history of     psychiatric disorders. At study entry, participants will have an interview, physical     examination, electrocardiogram (EKG), and blood and laboratory tests. Menstruating women will     have a pregnancy test and tests to determine menstrual phase and time of ovulation. At the     second clinic visit, participants will undergo tests of intelligence and cognitive abilities     and a magnetic resonance imaging (MRI) scan of the brain. Prior to Visits 3 and 4,     participants will collect their saliva and urine. Menstruating women will have a pregnancy     test. At Visits 3 and 4, participants will undergo TD studies and PET scanning. During one of     these visits, participants will take capsules of an amino acid. On the other day, they will     take lactose capsules. Throughout the study, participants will be asked about their emotional     state, anxiety, ability to concentrate, and well being.   "
168498|NCT00033813|"     This study will help to determine the safety and efficacy of the mast cell stabilizer     Oxatomide as a treatment for Duchenne muscular dystrophy (DMD). Boys with DMD who are     enrolled in this study will should not have taken steroids to treat DMD for at least twelve     months, and should not have taken any nutritional supplements for at least three months.     Subjects will complete a two screening visits within a one-week period, and if enrolled will     then have their strength tested monthly for three months before beginning therapy with     Oxatomide. Once Oxatomide therapy is started, participants will have their strength tested     monthly for six months. Following the six month treatment period, participants will be given     the option to remain on Oxatomide until the study is completed.   "
168499|NCT00033826|"     Vitamin D is a fat soluble vitamin that has important effects on calcium (including     absorption of calcium from the diet) and bone metabolism. Vitamin D is known to be stored in     fat tissue, and it is also present in the circulation. The purpose of this study is to     investigate the relationship between levels of vitamin D in fat tissue and in blood.   "
168500|NCT00033839|"     This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in     the treatment of an episodic cluster headache period compared to placebo (medically inactive     substance which does not contain any active ingredients).   "
168501|NCT00033852|"     The purpose of this study is to determine the effect of massage therapy on depression,     quality of life and plasma cortisol levels in subjects with advanced HIV disease.   "
168502|NCT00033865|"     The purpose of this study is to evaluate the effectiveness of a daily, 8-week treatment for     insomnia using yoga, relaxation exercises or sleep hygiene.   "
168503|NCT00033878|"     The purpose of this Phase 1 study is to: 1. determine the maximum tolerated dose of capsules     containing 500mg of freeze dried noni fruit extract, 2. define toxicities associated with the     ingestion of noni, 3. collect preliminary information on the efficacy of noni in respect to     anti-tumor and symptom control properties to help select specific patients for subsequent     Phase 2 studies, 4. identify chemical constituents of the extract that can be used to     characterize the bioavailability and pharmacokinetics of noni food supplement.   "
168509|NCT00034073|"     This study will use magnetic resonance imaging (MRI) to examine how blood flow to the brain     differs at different ages with the brain is at rest, and during performance of tasks that     involve language, memory, motor control, and sight. The study will evaluate the usefulness of     MRI in identifying language function and location, and may provide information on how the     brain develops over time to process brain functions, such as language and memory.      Healthy normal volunteers in three age groups-children 8-10, adolescents 13-16, and young     adults 21-30-may be eligible for this study. Participants must be right-handed and be native     English speakers. Candidates will be screened via a telephone interview and examination by a     neurologist.      Participants will undergo MRI scanning of the brain during rest or while performing a task     designed to test a skill. The tasks may involve remembering numbers, reading a word, tapping     fingers, or looking at a flashing picture. MRI uses a magnetic field and radio waves to     produce pictures of the brain. For the procedure, the subject lies still on a table that is     moved into the scanner (a cylinder containing the magnet). Earplugs are worn to muffle loud     noises caused by electrical switching of radio frequency circuits used in the scanning     process. Adults may spend as long as 90 minutes in the scanner, usually less than 45 minutes.     For children, the time is less than 75 minutes-usually 30 to 40 minutes. Participants may be     asked to repeat the scans up to 5 times in different sessions to test different brain     functions or confirm findings.   "
168523|NCT00034268|"     The purposes of this study are to determine:        1. If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer,          compared with gemcitabine and cisplatin alone.        2. The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be          associated with the combination of these three drugs.        3. Whether LY900003 plus gemcitabine and cisplatin can make your tumor smaller or          disappear, and for how long, compared with gemcitabine and cisplatin alone.      It is possible that information collected during this study will be analyzed by the sponsor     in the future to evaluate LY900003 plus gemcitabine and cisplatin for other possible uses or     for other medical or scientific purposes other than those currently proposed.      LY900003 may not add any benefit to gemcitabine plus cisplatin.   "
168524|NCT00034281|"     The purpose of this study is to investigate a safe dose of TAK-165, once daily (QD), in     patients with HER2-tumor expression.   "
168510|NCT00034086|"     The purpose of this study is to see how the body's immune system changes after replacing and     adding new anti-HIV drugs to a patient's current anti-HIV therapy. This study will also see     whether adding drugs is safe. Patients who take part in A5136 are also eligible to take part     in 2 substudies. The purpose of substudy A5140s is to see how many latently infected cells     (cells in which the HIV virus survives) are in the lymph node (small, rounded structures that     make disease-fighting cells). Substudy A5155s will be performed to see how many latently     infected cells are in the blood before and after replacing and adding anti-HIV drugs.      ACTG A5136 is a follow-up study to ACTG 315 and ACTG 375, which were designed to examine the     effects of highly active antiretroviral therapy (HAART) in certain HIV-infected patients.     Many HIV-infected patients have undergone long-term anti-HIV therapy and have had the virus     suppressed. However, most of these patients still have problems with their immune systems.     The reason for these problems is unknown. This study may help researchers understand what     causes immune system problems in people who have low levels of HIV in their blood.   "
168511|NCT00034112|"     The purpose of this study is to determine if osteopathic manipulative treatment (OMT) is     effective for persons with emphysema as a component of their chronic obstructive pulmonary     disease.   "
168512|NCT00034125|"     To determine the safety and efficacy of LY353381 when compared to tamoxifen in women with     advanced or metastatic breast cancer.   "
168513|NCT00034138|"     The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product     and OvaRex MAb-B43.13 cell culture product. Safety and immune responses following treatment     with the cell culture product will be evaluated.   "
168514|NCT00034151|"     Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly     S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or     IV platinum resistant ovarian cancer or primary peritoneal carcinoma.   "
168515|NCT00034164|"     Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly     S-8184 paclitaxel injectable emulsion in second line treatment of patients with relapsed     stage IIIB or IV non small cell lung cancer.   "
168516|NCT00034177|"     Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly     S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced,     metastatic, or recurrent transitional cell carcinoma of the urothelium.   "
168517|NCT00034190|"     Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly     S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or     IV colorectal adenocarcinoma.   "
168518|NCT00034203|"     The purpose of this study is to determine whether a humanized monoclonal antibody     (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.   "
168519|NCT00034216|"     This study will collect blood from patients with cancer to study the level of cells which     decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18     years of age and older with cancer may participate. This study does not involve treatment.      Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their     condition, patients may be invited to enroll in a clinical research study involving     chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during     the course of treatment.   "
168529|NCT00034359|"     The purpose of this study is to determine the safety and anti-HBV activity of ACH-126, 443     (beta-L-Fd4C) in comparison to lamivudine or placebo in treatment naive adults with chronic     Hepatitis B infection.   "
168535|NCT00034450|"     L-carnitine is a supplement (type of vitamin) that has been suggested to be decreased in     patients with cancer. We will identify patients that have terminal cancer and fatigue. The     purpose of this study is to determine if L-carnitine replacement improves fatigue in cancer     patients with L-carnitine deficiency.   "
168588|NCT00035165|"     This study will examine whether the new investigational drug EPO906, given by intravenous     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the     growth of cells that cause melanoma.   "
168520|NCT00034229|"     The purpose of this study is to evaluate the safety and effectiveness of the drug felbamate     for treating depression in patients with bipolar disorder that has not responded to standard     treatments.      Bipolar disorder is a severe, chronic, and often life-threatening illness. Despite the     availability of a wide range of antidepressant drugs, a proportion of patients fail to     respond to first-line antidepressant treatment despite adequate dosage, duration, and     compliance. Studies suggest that the glutamatergic system may play a role in the     pathophysiology and treatment of depression. Felbamate and other agents which reduce     glutamatergic neurotransmission may represent a novel class of antidepressants.      Participants in this study will be admitted to the Clinical Center for up to 10 weeks. At     study entry, participants will have a 7-day washout period in which they will be tapered off     all psychiatric medications, with the possible exception of lithium, and will be given a     placebo (an inactive pill). After the washout period, participants will be randomly assigned     to receive either felbamate or placebo for 8 weeks. Participants whose depression symptoms     worsen by more than 30% or those for whom study continuation is considered potentially     harmful will be taken off the study and offered open-label treatment. Participants who     received felbamate and responded well to treatment will have the option of continuing     treatment.   "
168521|NCT00034242|"     This study will examine whether high-dose intravenous immunoglobulin (IVIG) is safe and     effective for treating cerebellar ataxia-degeneration of the cerebellum, the part of the     brain responsible for coordinating muscle movements and balance. The disease causes a slowly     progressive impairment of speech and balance, with patients often developing slurred speech,     tremor, clumsiness of the hands, and walking difficulties (ataxia). IVIG is derived from     donated blood that has been purified, cleaned and processed into a form that can be infused.     IVIG is an immune suppressant that is routinely used to treat other neurological conditions.      Patients 18 years of age and older with hereditary (genetic) or sporadic (unknown cause)     cerebellar degeneration may be eligible for this 5-month study. They must have evidence of an     immune component to their condition, such as gluten sensitivity or antiganglioside     antibodies. Candidates will be screened with a neurological examination, a review of medical     records and possibly blood tests.      Participants will be randomly assigned to receive infusions of either IVIG or placebo (an     inactive substance) through an arm vein once a month for two months. The infusions will be     given in the hospital in doses divided over 2 days, each lasting 6 to 10 hours. Before the     infusions, patients will undergo ataxia assessments through tests of coordination and balance     that may involve finger tapping, walking in a straight line, talking, and eye movements. When     the treatment is finished, patients will be followed in the clinic once a month for 3 months     for blood tests repeat ataxia assessments to evaluate the effects of treatment.   "
168522|NCT00034255|"     The purpose of this study is to evaluate the safety and tolerability of single and multiple     doses of intramuscular INGAP Peptide given for the first time in humans as a potential     treatment for diabetes.   "
168570|NCT00034905|"     The purpose of this study is to show equal efficacy of both quetiapine and risperidone in     subjects treated with study medication for up to 8 weeks.   "
168525|NCT00034294|"     Approximately 300 patients will be entered into this study taking place throughout the United     States, Canada and the United Kingdom. This study aims to determine if an investigational     drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and     lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated     in comparison to current standard antibiotic treatment, so all patients will receive active     medication.      All study-related care is provided including doctor visits, physical exams, laboratory tests     and study medication. Total length of participation is approximately 10 weeks.   "
168526|NCT00034307|"     This is a clinical research study designed to evaluate an investigational new medication     called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA     functional class II, III or IV). The purpose of this study is to evaluate the safety and     effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment)     for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be     eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive     placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.   "
168527|NCT00034333|"     MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to stick, to     magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is     added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and     deposited in the area of a tumor, where it is thought that it then leaks through the blood     vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes free     from the magnetic beads and will then be able to act against the tumor cells. The iron     component of the particle has magnetic properties, making it possible to direct MTC-DOX to     specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that     MTC-DOX used with the magnet may target the chemotherapy directly to liver tumors and provide     a treatment to patients with liver cancer.      To be sure of the effect of MTC-DOX on liver cancer, it will be compared to the effect of     Doxorubicin given through the vein.      The study treatments will be administered every three weeks, (which is considered a study     treatment cycle), until you complete six treatment cycles, the tumor grows, disappears, or     you experience a side effect, which may cause you to leave the study. Follow-up visits will     occur on Days 3, 10, and 21 following treatment in the first cycle and Days 7 and 21 for the     remaining cycles, and also 60 days after you receive your last treatment cycle.      Therefore, the purpose of this Phase 2/3 study is to evaluate safety, tolerance, and efficacy     (survival time) of an MTC-DOX dosing strategy where the DOX dose is determined by tumor size   "
168528|NCT00034346|"     Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in     kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor     prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor     types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth.     Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal     antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a     Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in combination with     paclitaxel and carboplatin in the treatment of advanced NSCLC.   "
168530|NCT00034372|"     In this study, patients will be randomized to one of three dose regimen groups. Each dose of     OvaRex MAb-B43.13 is 2 mg by slow intravenous administration.      Group 1 will receive two doses, one month apart.      Group 2 will receive three consecutive monthly doses, then at 12-week intervals through 2     years or until disease relapse up to a total of 9 doses.      Group 3 will receive six consecutive monthly doses, then at 12-week intervals through 2 years     or until disease relapse up to a total of 11 doses.      The study will compare the time to disease relapse of patients who demonstrate an immune     response to OvaRex MAb-B43.13 with time to disease relapse of those who do not demonstrate an     immune response to OvaRex MAb-B43.13. Differences in the percentage of patients demonstrating     an immune response in each dose regimen group will also be assessed.   "
168531|NCT00034385|"     This study will compare different ways of giving the drugs ganciclovir and valganciclovir to     kidney or kidney and pancreas transplant recipients to determine the most effective dose of     valganciclovir for protecting against cytomegalovirus (CMV) infection in these patients. One     of the most common viral infections following organ transplant, CMV can cause serious illness     and even death.      Ganciclovir reduces the incidence of CMV disease after kidney transplantation. The drug is     given either intravenously (through a vein) twice a day or by mouth 3 times a day.     Valganciclovir is converted to ganciclovir in the body and is absorbed into the bloodstream     better than oral ganciclovir. In most transplant patients, a single daily dose of     valganciclovir prevents CMV. Because of these advantages, some transplant patients are being     given valganciclovir instead of ganciclovir to prevent CMV infection. However, the drug has     not been studied in kidney and kidney transplant patients. This study will provide dosing     information for this patient population.      Patients 18 years of age and older who have had a kidney or kidney and pancreas transplant at     the NIH Clinical Center may be eligible for this study. Participants will undergo the     following treatments and procedures:      - Phase 1 - Treatment with intravenous ganciclovir for at least 7 days after transplantation.      Sometime before starting phase 2, patients will provide a 24-hour urine collection to test     for kidney function. The day before starting phase 2, they will have a cannula (small needle)     inserted into an arm vein for about 12 hours to draw blood samples-one before starting the     ganciclovir infusion, then at 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 12 hours after     the dose.        -  Phase 2 - Treatment with oral valganciclovir once a day for 7 to 21 days at a dose          approximately equivalent to intravenous ganciclovir. Sometime between 4 and 21 days on          this dose, patients will have blood sampling in the morning before taking the drug and          then at 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours after the dose.        -  Phase 3 - Treatment with valganciclovir at a dose reduced by half to approximate oral          ganciclovir dosing.      After at least 4 days on this dose, patients will be admitted to the hospital for 1 day for     blood sampling before the drug dose and then at 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours     after the dose. Kidney function will be assessed by blood tests within 2 days of the blood     sampling. If kidney function is not within the normal range, further dosing and blood     sampling will be delayed until kidney function returns to the normal range.      - Phase 4 - Treatment with oral ganciclovir every 8 hours. After at least 4 days on this     regimen, patients will be admitted to the hospital for 1 day for blood sampling before the     drug dose and then at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after the dose. Kidney function will     be estimated by blood tests within 2 days of the blood sampling. If kidney function is not     within the normal range, further dosing and blood sampling will be delayed until kidney     function returns to normal range.      After completing phase 4, patients will continue valganciclovir daily or oral ganciclovir     treatment and blood sampling for a length of time prescribed by the transplant surgeon.   "
168543|NCT00034554|"     Up to 24 patients with stage III or stage IV melanoma will be enrolled. Patients who are     currently disease-free but at high risk for relapse are also eligible. Patients will receive     vaccinations of gp75 at assigned dose levels. Patients who exhibit serologic and     stable/clinical response are eligible to receive booster vaccinations. Patients will be     evaluated for safety and efficacy throughout the duration of the study. In this study, the     optimal biologically effective dose is defined as the lowest dose of gp75 that results in the     production of anti-gp75 antibodies.   "
168544|NCT00034567|"     This project will focus on the development and testing of efficient, cost effective measures     that are specifically designed for use in Alzheimer's Disease (AD) primary prevention trials.   "
168532|NCT00034398|"     This study will investigate how the brain generates tics in patients with Tourette's syndrome     and which areas of the brain are primarily affected. Tourette's syndrome is a     neuropsychiatric disorder characterized by motor and vocal tics, and is associated with     behavioral and emotional disturbances, including symptoms of attention deficit hyperactivity     disorder and obsessive-compulsive disorder. This study will examine whether tic generation is     related to changes in brain cell receptors for a chemical messenger called gamma-aminobutyric     acid (GABA).      Healthy normal volunteers and patients with Tourette's syndrome between 21 and 65 years of     age may be eligible for this study. Candidates will be screened with a medical history and     physical and neurological examinations.      Participants will undergo positron emission tomography (PET) scanning to measure brain blood     flow. For this procedure, the subject receives an injection of H215O, a radioactive substance     similar to water. A special camera detects the radiation emitted by the H215O, allowing     measurement of the blood flow. Subjects will receive up to five injections of H215O during     the scanning. They will also be injected with another radioactive chemical, (11C) flumazenil,     which binds to GABA receptors, to measure the density and distribution of these receptors.     This will reveal which areas of the brain in patients with Tourette's syndrome have abnormal     binding of flumazenil compared with the brains of healthy control subjects.      During the PET procedure, the subject lies on a table in the PET scanner. A small catheter     (plastic tube) is placed in an arm vein for injecting the radioactive tracers, and a mask is     placed on the face to help keep the head still during scanning. The mask has large openings     for eyes, nose and mouth, so that it does not interfere with talking or breathing. The entire     test takes about 3 hours.      On a separate day, participants will also undergo magnetic resonance imaging (MRI), a     diagnostic test that uses a magnetic field and radio waves to produce images of the brain.     For this procedure, the subject lies still on a stretcher that is moved into the scanner (a     narrow cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by     electrical switching of radio frequency circuits used in the scanning process. The scan lasts     about 45 to 60 minutes.   "
168533|NCT00034424|"     Background:      People with a family history of testicular cancer may be at increased risk for the disease.      Genetic and clinical studies of patients with testicular cancer and their family members may     help clarify the cause of the disease and identify clinical features.      Objectives:      To characterize the clinical features of testicular cancer.      To identify genes that may lead to increased risk of the disease.      To examine emotional and behavioral issues of members of families at increased risk of the     disease.      Eligibility:      Males and females from a family with at least two cases of testicular cancer in blood     relatives.      Males with testicular cancer in both testicles.      Males with testicular cancer who have an identical twin.      Participants must be at least 12 years of age.      Design:      Participants may take part in Part 1 or Parts 1 and 2 of this 2-part study.      Part 1 participants:        -  Provide a blood or cheek cell sample to obtain DNA for gene studies.        -  Provide permission for researchers to obtain their medical records for review.        -  Complete questionnaires about their personal and family medical history, exposure to          factors that might influence the risk of testicular cancer, and their feelings about          being a member of a family in which several members have testicular cancer.        -  These data are collected from participants in their home communities.      Part 2 participants:        -  All participants provide a medical history, have a complete physical examination,          including routine lab tests, and have an ultrasound test of the abdomen to look at the          kidneys.        -  Males have an ultrasound test of the testicles and scrotum.        -  Females have an ultrasound test of the pelvis to look at the ovaries, uterus and          fallopian tubes.        -  Males 18 years of age and older provide a semen sample.        -  Some participants have computed tomography (CT) scanning of the chest, abdomen and          pelvis instead of kidney ultrasound. Children under 18 years of age may have magnetic          resonance imaging (MRI) instead of CT.        -  These data are collected from participants during a 2-day visit to the NIH Clinical          Center in Bethesda, MD. Travel costs are covered by the protocol.   "
168534|NCT00034437|"     This study will evaluate immune responses against cytomegalovirus (CMV). About 80 percent of     adults have been exposed to this virus. CMV typically remains dormant (inactive) in the body,     causing no problems. In people with immune suppression, however, the virus can become     reactivated and cause life-threatening pneumonia. The knowledge gained from this study may be     useful in developing ways to improve immune responses to CMV in stem cell transplant     recipients.      Healthy normal volunteers between 18 and 65 years of age who have been exposed to     cytomegalovirus are eligible for this study. Candidates will be screened with a medical     history and blood tests. Those enrolled will provide a 30-milliliter (6-tablespoon) blood     sample once a week for 4 weeks and a final sample 2 months later. The blood will be used to     design a test to detect immune responses against CMV and determine the differences in these     responses among healthy individuals.   "
168617|NCT00035542|"     The purpose of this clinical research study is to see if Glucovance, a medication currently     approved for use in adults with type 2 diabetes, can control type 2 diabetes safely and     effectively in children 9 to 16 years of age.   "
168536|NCT00034463|"     This is a non-randomized, phase 1, study with the primary objective of determining the     toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10     minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in     lightly or heavily pre-treated patients with locally advanced or metastatic cancer.   "
168537|NCT00034476|"     The purpose of this study is to determine whether the administration of the study drug is     effective in increasing the chance of survival in patients with severe sepsis. Patients     entered into this study will be randomly assigned to one of two treatment groups. Patients in     each treatment group will be given either the study drug or placebo as a continuous infusion     directly into the bloodstream through a catheter placed in one of the patient's veins.      The study drug is an investigational drug that is still in development. It has been studied     in approximately 30 healthy subjects, approximately 30 patients with either kidney failure or     arthritis, and approximately 600 patients with severe sepsis. Patient participation in this     study will last for about one month.   "
168538|NCT00034489|"     This is a study to explore how well the combination of LY231514 and Gemcitabine work together     in patients with breast cancer that has spread beyond the location of the original tumor.     Patients must have previously received treatment with anthracycline and taxane chemotherapy     drugs.   "
168539|NCT00034502|"     This is a non-randomized study in patients who have received prior 5-FU therapy for     colorectal cancer. The objective of this trial is to establish a maximum tolerated dose of     ALIMTA and irinotecan given in combination as well as to assess the safety and efficacy of     this combination for patients with locally advanced or metastatic colorectal cancer. ALIMTA     and irinotecan will be given every 21 days.   "
168540|NCT00034515|"     The purpose of this ascending dose group study is to assess the safety, tolerability, and     effects of multiple dose levels of INS37217 and placebo followed by five days twice daily     treatment with maximum tolerated dose administered by inhalation via the Pari LC Star     nebulizer in adult and pediatric patients with cystic fibrosis   "
168541|NCT00034528|"     The purpose of this study is to find out if using a lower dose of chemotherapy before stem     cell transplantation can cure patients of sickle cell anemia or thalassemia while causing     fewer severe side effects than conventional high dose chemotherapy with transplantation.   "
168542|NCT00034541|"     The study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small     cell lung cancer patients. Patients will receive cetuximab in combination with carboplatin     and paclitaxel for two cycles or until disease progression or until the patient exhibits     intolerable toxicities. Patients will be evaluated for efficacy and safety throughout the     duration of the study.   "
168571|NCT00034918|"     The purpose of this study is to assess the efficacy of ZD6474 in patients with metastatic     breast cancer at 2 dose levels.   "
168549|NCT00034632|"     This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH     56592) under an open label, treatment protocol for subjects with invasive fungal infections:      A. which are refractory or resistant to standard antifungal therapies; B. for which there are     currently no effective therapies; C. with a prior history of serious, severe or     life-threatening toxicities while receiving antifungal therapy; D. with pre-existing organ     dysfunction which precludes the administration of standard antifungal therapies.   "
168550|NCT00034645|"     This trial is in high risk patients to determine the safety, tolerance and efficacy of     posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal     infections (IFI).   "
168551|NCT00034658|"     This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH     56592) under an open label, treatment protocol for subjects with invasive fungal infections:      A: which are refractory or resistant to standard antifungal therapies; B: for which there are     currently no effective therapies; C: with a prior history of serious, severe or     life-threatening toxicities while receiving antifungal therapy; D: with pre-existing organ     dysfunction which precludes the administration of standard antifungal therapies.   "
168552|NCT00034671|"     This phase II study will be conducted to:        1. evaluate the pharmacokinetics, safety, tolerance, and efficacy of different dosing          schedules of Posaconazole in immunocompromised hosts with a variety of refractory          invasive fungal infections or in subjects who require empiric antifungal therapy and        2. identify the dosing schedule that provides the most consistent therapeutic drug exposure          in this patient population.   "
168553|NCT00034684|"     The purpose of this study is to determine the safety and tolerability of an oral Farnesyl     Protein Transferase Inhibitor (SCH 66336) as a single agent in patients with Advanced     Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia in Blast     Crisis, or Acute Lymphoblastic Leukemia.   "
168554|NCT00034697|"     Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually.     Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain     radiation and steroids will improve neurologic symptoms in about 50% of patients although     survival is short. This study will test the safety and efficacy of temozolomide in     combination with radiation therapy in the treatment of patients with brain mets form nonsmall     cell lung cancer.   "
168555|NCT00034710|"     The purpose of this study is to gain initial information on the tolerability of high-dose     capsaicin patches in patients with Painful Postherpetic Neuralgia. The study will also     collect preliminary information on safety and efficacy.   "
168586|NCT00035139|"     Traumatic Brain Injury (TBI) is the leading cause of acquired long term disability among     children and young adults. Deficits in attention and memory are common and persist for years     after moderate or severe TBI. The similarity between these symptoms and those of children     with AD/HD, the efficacy of methylphenidate in the treatment of AD/HD, and the efficacy of     methylphenidate in improving recovery of animals with brain injuries, support the need to     study methylphenidate effects in children with TBI. This investigation of methylphenidate in     children with moderate to severe TBI aims to: (1) Assess the acute effects of 2 different     dosages of methylphenidate on attention and reaction time when the medication is administered     to children early in recovery; (2) Assess the ability of 8 weeks of methylphenidate to     improve the rate of recovery of cognitive, memory, and attentional skills in children with     TBI; (3) Identify the frequency of common methylphenidate side effects in children with TBI.   "
168556|NCT00034723|"     This study will use three different magnetic resonance imaging (MRI) techniques to study     HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/STP)-a disease of slowly     progressive weakness in the legs. It is not known how the HTLV-1 virus causes this disease,     but it is thought that as the body's immune system tries to destroy the virus, parts of the     nervous system-primarily the spinal cord-are damaged.      Patients 18 years of age and older with HAM/TSP and healthy normal volunteers may be eligible     for this study.      Participants will undergo diffusion tensor MRI, MR-spectroscopy, and magnetization transfer     imaging to look at different compositional, architectural, and microscopic properties of the     brain. All of these techniques are similar to conventional MRI, and like the conventional     method they use a strong magnetic field and radio waves to measure structural and chemical     changes in brain tissue. Each of the three scans will be done on separate days, each lasting     about 1 hour. For the procedures, the patient or volunteer lies on a stretcher in a narrow     metal cylinder (the scanner) and is asked to remain still for 15 to 30 minutes at a time. A     special lightweight coil may be placed on the head to enhance the brain images. The subject     can communicate with the person doing the scan at all times.   "
168557|NCT00034736|"     The purpose of this study is to determine the safety and efficacy of levofloxacin in the     treatment of children with community acquired pneumonia.   "
168558|NCT00034749|"     A clinical study to compare the safety and effectiveness of two different dose ranges of     risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia.   "
168559|NCT00034762|"     The purpose of this study is to evaluate the efficacy and safety of risperidone compared with     placebo in the treatment of psychotic symptoms in patients with Alzheimer's disease   "
168560|NCT00034775|"     The primary purpose of the study is to assess the safety and tolerability of a long-acting     injectable formulation of risperidone when switching from an oral antipsychotic in patients     with schizophrenia.   "
168561|NCT00034788|"     The purpose of this study is to evaluate the efficacy and safety of REGRANEXÂ® Gel compared     with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers     of the ankle or foot related to diabetes.   "
168562|NCT00034801|"     This is a research study comparing the safety and efficacy of two active study medications   "
168563|NCT00034814|"     To compare seizure frequency in patients with refactory partial seizures (with or without     generalization) who are taking Talampanel versus placebo as an add-on therapy to other     licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in     this group of patients.   "
168564|NCT00034827|"     CI-1040 is an experimental drug that is being tested in patients who have advanced colorectal     and lung cancer who failed no more than one prior chemotherapy regimen, breast cancer who     have failed no more than 2 prior regimens and in patients with pancreatic cancer who have     received no prior chemotherapy. CI-1040 is taken orally twice daily with meals. Patients are     required to have blood tests periodically while receiving treatment and will be monitored     closely throughout the trial for possible side effects and for response.   "
168565|NCT00034840|"     The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically     superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed     dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to     demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the     last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active     study medication at the end of a 6 to 8-week treatment period.   "
168566|NCT00034853|"     To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral     suspension in children with Juvenile Rheumatoid Arthritis (JRA)   "
168578|NCT00035035|"     Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA     for the treatment of cancer of the pancreas. Patients may be able to participate in this     study if they have cancer in their pancreas that cannot be removed by surgery OR that has     spread to a new site in their body.   "
168579|NCT00035048|"     A clinical study to determine the efficacy and safety of an investigational medication     (MK0869) in the treatment of depression.   "
168580|NCT00035061|"     Patients with bladder cancer will be participating in this study for the treatment of     abnormal cells in the bladder that have returned after initial treatment OR have moved to a     new site in the body.   "
168581|NCT00035074|"     Patients with inflammatory bowel disease (IBD) who require methotrexate (MTX)for treatment     currently receive this drug by injection. MTX is also available as a pill that can be given     by mouth but it is not known how well the drug enters the body in patients with Crohn's     disease or ulcerative colitis. This study is being done to compare how much MTX enters the     body when the drug is taken by mouth compared to when it is given by injection. If the drug     is well absorbed, it may allow patients to receive the drug by mouth.   "
168582|NCT00035087|"     This study will examine whether the new investigational drug EPO906, given by intravenous     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the     growth of cells that cause colorectal cancer.   "
168583|NCT00035100|"     This study will examine whether the new investigational drug EPO906, given by intravenous     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the     growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the     United States is complete but the study is still enrolling in other countries.   "
168584|NCT00035113|"     This study will examine whether the new investigational drug EPO906, given by intravenous     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the     growth of cells that cause prostate cancer.   "
168585|NCT00035126|"     This study will examine whether the investigational drug EPO906, given by intravenous     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the     growth of cells that cause breast cancer.   "
168587|NCT00035152|"     Taxol and carboplatin are commonly used drugs for the treatment of stage IIIB or IV non small     cell lung carcinoma.      This study compares treatment with Taxol/carboplatin given every 3 weeks to a schedule where     it is given weekly.      The purpose of the study is to determine the most effective and safe schedule for giving     these drugs in non small cell lung carcinoma.   "
168589|NCT00035178|"     The primary goals of this investigation are to provide guidance on how to dose Argatroban in     patients undergoing hemodialysis and to assess the safety and tolerability of Argatroban in     hemodialysis patients. The secondary goal of the study will be to assess the adequacy of     anticoagulation during hemodialysis.   "
168590|NCT00035191|"     This is a trial to evaluate the safety and effectiveness of galantamine in patients with     dementia secondary to blood vessel disease in the brain.   "
168591|NCT00035204|"     The purpose of this study is to evaluate the relative effects of galantamine compared to     donepezil (both cholinesteraste inhibitors), on sleep, attention, and gastrointestinal     tolerance in patients with Alzheimer's disease.   "
168592|NCT00035217|"     There is controversy concerning the preferred treatment for men with localized prostate     cancer with regard to the relative effectiveness of different treatments in controlling the     cancer and how different treatments affect the patient's quality of life. The purpose of this     research is to describe the disease course of prostate cancer and to determine the     effectiveness, potential complications, and quality of life after different treatments in men     with prostate cancer detected via screening with prostate-specific antigen (PSA) and/or     digital rectal examination   "
168593|NCT00035230|"     The primary purpose of this study is to evaluate the safety and efficacy of topiramate     compared with placebo in the treatment of acute manic or mixed episodes in patients with     Bipolar I Disorder.   "
168594|NCT00035243|"     This study will examine whether the investigational drug EPO906, given by intravenous     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the     growth of cells that cause kidney cancer.   "
168595|NCT00035256|"     The purpose of this study is to determine whether the increase in spine bone mineral density     that has been generally observed in previous clinical studies involving the study drug can be     maintained or even increased if followed with raloxifene HCl. All qualifying study     participants will receive the study drug followed by treatment with raloxifene HCl or     placebo. All study participants will receive raloxifene HCl in the third phase of the study.   "
168596|NCT00035269|"     This study will treat patients who have a community-acquired pneumonia that is due to a     specific bacteria (S. pneumoniae)   "
168597|NCT00035282|"     A clinical study to determine the efficacy and safety of an investigational medication     (MK0869) in the treatment of depression.   "
168598|NCT00035295|"     A clinical study to determine the efficacy and safety of an Treatment of MK0869      in the treatment of depression.   "
168599|NCT00035308|"     The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and     effective in delaying and reducing renal flares in patients with lupus nephritis.   "
168600|NCT00035321|"     The purposes of this study are to determine:        -  Whether olanzapine plus fluoxetine in combination will help patients with          treatment-resistant major depression.        -  The safety of olanzapine plus fluoxetine in combination, plus and any side effects that          might be associated with the combination.        -  The effectiveness of olanzapine plus fluoxetine compared to olanzapine and fluoxetine          alone.   "
168601|NCT00035334|"     The main objective of this study is to evaluate the safety and efficacy of NC-503 compared to     placebo in patients with secondary (AA) amyloidosis using a composite assessment of clinical     improvement/worsening of both renal and gastrointestinal functions.   "
168602|NCT00035347|"     A trial in which patients over 18 years of age who are hospitalized with community acquired     pneumonia and are otherwise eligible for entry into the study are randomly selected to     receive one of two treatment regimens. After written informed consent is obtained, patients     will receive one of the following two treatment regimens: 1) intravenous administration of     azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous     administration of levofloxacin followed by levofloxacin tablets. At least four study visits     are normally conducted up to approximately one month after starting therapy. The objective of     this study is to compare the safety and efficacy of the two treatment regimens.   "
168603|NCT00035360|"     This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron,     1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients     compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added     to stable optimized background antiretroviral therapy in this patient population.   "
168604|NCT00035373|"     The objective of this study is to evaluate patients with tumors of the central nervous system     (CNS) for eligibility in the National Cancer Institute s research studies. These patients     will undergo a series of procedures, usually including a complete medical history and     physical examination; laboratory testing of blood, CSF, urine, bone marrow, or other samples;     an evaluation of tumor location and size by x-rays, CT (computed tomography) or MRI (magnetic     resonance imaging) scans, or nuclear medicine scans; lumbar puncture; electrocardiogram and     echocardiogram; and procedures to evaluate the function of specific organs. A bone marrow     biopsy is occasionally performed. Research samples may also be collected and stored to avoid     having to do a painful test more than once. Tissue specimens collected during this process     may be stored and used in future studies.      Patients of both genders, any age, and all racial and ethnic groups with tumors of the CNS or     a history of a CNS tumor are eligible. Up to 100 people are expected to participate.      The physician will discuss the results of these procedures with the patient and his or her     family. On the basis of the eligibility screening and the patient s wishes, the patient may     then be enrolled in a primary research protocol.   "
168613|NCT00035490|"     Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular     tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the     heart. ICD therapy is established as highly effective for stopping life-threatening     arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to     decrease the frequency of ICD shocks.      The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of     ICD shocks has been investigated previously in a placebo-controlled study in patients with     ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled     study with approximately 600 patients.   "
168614|NCT00035503|"     The purpose of this study is to see if etiprednol dicloacetate is safe and effective for the     treatment of acute Crohn's disease.   "
168605|NCT00035386|"     This study will test the feasibility of a modified procedure for treating obstructive     hypertrophic cardiomyopathy (OHC). Patients with OHC have a thickening of the heart muscle     that obstructs blood flow out of the heart, causing breathlessness, chest pain, palpitations,     tiredness, lightheadedness, and fainting.      The current treatment for OHC is a procedure called alcohol septal ablation (also     percutaneous transluminal septal ablation, or PTSA), which involves injecting a small amount     of alcohol into a tiny artery that supplies the part of muscle causing blood flow     obstruction. The success of PTSA is limited, however, by problems of heart anatomy and the     ability to find the appropriate artery to inject. Modifying the procedure by injecting the     alcohol through the wall of the lower right chamber of the heart may improve its safety and     effectiveness. The new technique requires positioning a catheter (a flexible tube) into the     appropriate area of the heart. This study will test the ability to accurately guide the     catheter to that area.      Patients with OHC 18 years of age and older who are scheduled to have a cardiac     catheterization may be eligible for this study. At the end of the catheterization procedure,     participants will undergo intra-cardiac echocardiographic imaging. For this test, one of the     catheters placed in the femoral artery (at the top of the leg) for cardiac catheterization     will be substituted for a larger one. Through this catheter, a special catheter will be     introduced and advanced to the heart to provide images. This pilot feasibility study does not     involve injection of alcohol.   "
168606|NCT00035399|"     This study will examine the efficacy of acupuncture in combination with exercise physical     therapy for moderate osteoarthritis (OA) of the knee.   "
168607|NCT00035412|"     The purpose of this study is to determine the effectiveness of St. John’s Wort as compared to     placebo (an inactive substance) in the treatment of outpatients with social phobia.   "
168608|NCT00035425|"     This study will treat patients who have fever and neutropenia (after cancer chemotherapy)     that is possibly due to a specific bacteria (gram positive bacteria).   "
168609|NCT00035438|"     The purpose of this study is to determine the effectiveness of St. John’s Wort as compared to     placebo (an inactive substance) in the treatment of outpatients with obsessive compulsive     disorder.   "
168610|NCT00035451|"     Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common     supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic     therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm     (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.      The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy     and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug,     in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct     heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a     second phase with a different study design will be conducted. The second phase is an     open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate     the long-term safety of a daily oral dose of azimilide in patients who complete the     double-blind, placebo-controlled phase of this study.   "
168624|NCT00035633|"     The purpose of this clinical research study is to assess the safety effectiveness of     entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B     infection who are hepatitis B e antigen positive.   "
168625|NCT00035659|"     To study the natural history of the accumulation of intra-abdominal fat as women progress     through the menopause.   "
168626|NCT00035672|"     To evaluate how current genetic information about cardiovascular disease susceptibility genes     contributes to the prediction of future cardiovascular disease outcomes.   "
168611|NCT00035464|"     Atrial fibrillation (an abnormal rhythm in the upper chamber of the heart) is a common     supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic     therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm     (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.     Azimilide may have an effect on increasing the time to first recurrence of symptomatic atrial     fibrillation or atrial flutter and symptomatic paroxysmal supraventricular tachycardia (other     types of abnormal heart rhythms).      This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety     of azimilide compared with placebo in prolonging the time to the first symptomatic arrhythmia     recurrence in patients with a history of atrial fibrillation and congestive heart failure     and/or ischemic heart disease) and those without these conditions. Once this phase of the     study is completed, a second phase with a different study design will be conducted. The     second phase is an open-label, follow-up phase. The follow-up phase of the study is designed     to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in patients     who complete the double-blind, placebo-controlled phase of this study.   "
168612|NCT00035477|"     Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common     supraventricular arrhythmia (abnormal heart rhythm) for which antiarrhythmic therapy is often     prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm)     and to reduce the occurrence of episodes of atrial fibrillation. Azimilide may have an effect     on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial     flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal     heart rhythms).      This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety     of azimilide compared with placebo in maintaining sinus rhythm in patients who require     cardioversion (electric shock to correct heart rhythm) to reduce atrial fibrillation. Once     this phase of the study is completed, a second phase with a different study design will be     conducted. The second phase is an open-label follow-up phase to the study. This follow-up     phase will continue to evaluate the long-term efficacy and safety of a daily oral dose of     azimilide in patients who complete the double-blind, placebo-controlled phase of this study.   "
168615|NCT00035516|"     The purpose of this clinical research study is to learn if BMS-247550 can shrink or slow the     growth of the cancer in patients with non-small cell lung cancer who have failed first-line     platinum based chemotherapy. The safety of this treatment will also be studied.   "
168616|NCT00035529|"     The purpose of this study is to determine whether BMS-188667 will decrease multiple sclerosis     disease activity on MRI examinations, as well as decrease the rate of clinical MS     exacerbations, compared to placebo   "
168618|NCT00035555|"     The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is     as efficacious as treatment with cyclosporine at preventing acute rejection and with a     superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid     problems, less diabetes mellitus).   "
168619|NCT00035568|"     The purpose of this clinical research study is to support earlier observations that     Glucovance controls glucose levels after a mean, and improves overall glucose control better     than metformin or glyburide therapy alone in adults with type 2 diabetes.   "
168620|NCT00035581|"     This is an open-label, prospective, randomized, controlled study of the safety and efficacy     including clinical, immunologic, and virologic assessments of adding Ampligen to HAART in     HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml     (PCR).   "
168621|NCT00035594|"     Physicians are conducting a clinical trial for patients with advanced breast cancer. Breast     cancer can be treated with chemotherapy which can affect the bone marrow, where blood cells     are produced. Neutrophils are a type of white blood cells that fight infection and are     produced in the bone marrow. If the neutrophil count becomes low due to chemotherapy, a     potentially serious condition called neutropenia occurs. Neutropenia is serious because it     can affect the body's ability to protect against many types of infections. Pegfilgrastim is     an investigational drug being evaluated for its potential ability to increase the number of     neutrophils. The purpose of this study is to determine the safety and effectiveness of     pegfilgrastim in preventing neutropenia following chemotherapy in patients with advanced     breast cancer.   "
168622|NCT00035607|"     This study is investigating darbepoetin alfa for the treatment of anemia in patients with     non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein     that stimulates the production of red blood cells. In this study, darbepoetin alfa will be     administered as either an injection under the skin (subcutaneously) or directly into a vein     (intravenously).   "
168623|NCT00035620|"     Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a     type of bone cancer that can be treated with chemotherapy which can affect the bone marrow,     where blood cells are produced. Neutrophils are a type of white blood cells that fight     infection and are produced in the bone marrow. If the neutrophil count becomes too low due to     chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is     serious because it can affect the body's ability to protect against many types of infections.     Pegfilgrastim is an investigational drug being evaluated for its potential ability to     increase the number of neutrophils. The purpose of this study is to determine the safety and     effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric     patients up through the age of 21 with sarcoma.   "
168635|NCT00035789|"     The purpose of this clinical research study is to assess the safety and effectiveness of     entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B     infection who are hepatitis B e antigen negative.   "
168636|NCT00035802|"     The purpose of this study is to determine the safety and efficacy of topiramate in     adolescents with manic or mixed episodes of Bipolar I Disorder.   "
168637|NCT00035815|"     The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I)     slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients. Study     participants will be followed for 2 years once enrolled. They will receive either placebo or     the active IGF-I. Examinations will take place at approximately 6-month intervals.   "
168638|NCT00035828|"     To determine if ABX-IL8 will improve shortness of breath.   "
168639|NCT00035841|"     The purpose of this study is to determine the effectiveness of TLK286 in treatment of     metastatic breast cancer.   "
168640|NCT00035854|"     This study will treat pediatric patients who have infections that are due to a specific     bacteria (Vancomycin-Resistant Enterococcus)   "
168641|NCT00035867|"     The purpose of this study is to determine the safety and efficacy of TLK199 in patients with     myelodysplastic syndrome (MDS).   "
168642|NCT00035880|"     Trial evaluating the improvement in survival at 180 days of two therapies (Atgam versus     ABX-CBL, a monoclonal antibody) in patients with acute graft versus host disease that does     not respond to steroid therapy.   "
168643|NCT00035893|"     This is an open-label, prospective, randomized, controlled study of the safety and efficacy     including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic     Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR)     and CD4 levels > 400.   "
168644|NCT00035906|"     The purpose of this clinical research study is to evaluate the safety and effectiveness of an     investigational medication to treat macular edema that persists despite current treatment     methods. Participants will be evaluated for improvement in vision and side effects.      Macular edema is a condition that affects the back of the eye (retina). It frequently occurs     in people who have a history of diabetes, and is also associated with high blood pressure,     uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision,     generally a blurring of central vision.      There are no direct costs to participants for assessments and treatment as defined in the     study protocol. All candidates must be available for required scheduled visits during the     trial's 6-month follow-up period. Although the disease called age-related macular     degeneration (AMD) affects the same region of the eye as macular edema, they are not the same     condition and AMD is not studied in this research trial.   "
168655|NCT00036075|"     The purpose of this study is to investigate whether an investigational drug, CP-461, is safe     and effective for the treatment of patients with prostate cancer and who have measurable     disease.   "
168656|NCT00036088|"     The purpose of this study is to determine how Olanzapine compares to an active comparator in     the treatment of schizophrenia   "
168657|NCT00036101|"     The purpose of this study is to learn if aripiprazole is effective for the treatment of     patients with acute symptoms of Bipolar disorder.   "
168658|NCT00036114|"     The purpose of this study is to learn if aripiprazole is safe and effective in the treatment     of psychosis associated with dementia of the Alzheimer's type.   "
168659|NCT00036127|"     Study to learn if the alternate formulation is effective in agitated schizophrenic patients   "
168645|NCT00035919|"     This is a Phase I safety study of a gene transfer drug for colorectal cancer that has spread     to the liver. The main purpose of this study is to determine if it is safe to give this new     intervention to persons with cancer, but we will also look for indications that the drug is     effective. Although the findings in animals that have cancer are encouraging, this is the     first time humans will receive this experimental gene transfer drug. A gene called cyclin G1     has been shown to play a very important part in cancer growth. In animal experiments, a     genetically modified virus (or vector)carrying a modified cyclin G1 gene caused the cancerous     tumors to grow much slower or even die. In this safety study, the drug will be injected     through the liver artery to get it near the cancer that has spread to the liver. The way the     gene gets into the cancer cells is by using a targeted vector that concentrates in the area     of the cancer to improve the delivery of the killing gene into cancer cells. The vector we     are using is a virus that has been changed so that the infectious genes have been removed and     instead carries the modified cyclin G1 gene.   "
168646|NCT00035932|"     The purpose of this study is to learn how well atazanavir (ATV) works in combination with     ritonavir (RTV) or saquinavir (SQV) with tenofovir (TDF) and a nucleoside to reduce the viral     load of treatment experienced subjects with human immunodeficiency virus (HIV). There is a     comparison arm with lopinavir (LPV)/RTV and TDF and a nucleoside.   "
168647|NCT00035945|"     Purpose of this study is to evaluate the safety, tolerability, antiviral activity, and     pharmacokinetic behavior of ISIS 14803 administered for up to 12 weeks by intravenous     infusions in patients with chronic hepatitis C.   "
168648|NCT00035958|"     Juvenile dermatomyositis (JDMS) is one of the most serious of the childhood rheumatic     diseases. The theory behind this trial is that early introduction of etanercept or     methotrexate will prove to be effective in the treatment of JDMS. Pretreatment muscle     biopsies, we believe there will be abnormalities in the blood vessels that will be correlated     with worse physical strength and daily functional ability. The long-term goal is to improve     the treatment of this serious childhood onset rheumatic disease and to better understand the     pathogenic mechanism for the development of the vasculopathy (disorder of blood vessels) of     JDMS. Identification of the specific mechanism of the vasculopathy may allow for the rational     introduction of biologic treatments focused on vascular growth.   "
168649|NCT00035971|"     The purpose of this study is to determine how treatment with raloxifene compares to treatment     with alendronate in postmenopausal women with osteoporosis on the chance of experiencing     fractures   "
168650|NCT00035984|"     This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on     glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients     will be randomized into one of two AC2993 treatment arms or to placebo treatment and will     continue with their required existing diabetes medications (metformin and a sulfonylurea)     throughout the study.   "
168672|NCT00036296|"     The purpose of this research study is to test the safety and effectiveness of the study drug,     Talampanel, when used to treat patients with involuntary movements known as dyskinesias, as a     result of treatment to Parkinson's disease.      It is not clear why people with Parkinson's disease develop involuntary movements     (dyskinesias) but studies show that blocking receptors in the brain for a chemical called     glutamate decreases these movements. Talampanel is a drug which blocks these receptors.   "
168673|NCT00036309|"     The purpose of this study is to determine if duloxetine is effective when compared to placebo     in preventing recurrence of major depressive disorder in patients who have responded to     open-label duloxetine treatment.   "
168651|NCT00035997|"     The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic     acid for injection in 100mg solution ) has in preventing associated bone loss in prostate     cancer patients with bone metastasis when administered in conjunction with hormonal cancer     therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing     bone mineral density in these patients.      This prospective, open-label, single arm, multicenter study will enroll approximately 200     prostate cancer patients with a history of at least one documented bone lesion documented by     bone scan or radiograph. Patients must already be receiving hormone therapy and meet the     following additional criteria:        -  18 years of age or older        -  Histologically confirmed diagnoses of prostate cancer        -  Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or          radiograph        -  Received or will receive hormonal treatment also know as androgen deprivation therapy          with an LHRH agonist or other hormonal treatments      Throughout the course of this 12-month trial, patients will be identified based on the     duration of established hormonal treatment at the time of enrollment. Each patients duration     of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a     4 week follow up.   "
168652|NCT00036023|"     Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red     blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and     shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone     marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in     the laboratory and has the same effect as the hormone produced by the body. Use of     recombinant human erythropoietin allows the body to produce more red blood cells, possibly     eliminating or decreasing your symptoms and the need for a red blood cell transfusion.     Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving     chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for     the treatment of anemia in patients with non-myeloid malignancies who are receiving     chemotherapy every three weeks. Darbepoetin alfa is a recombinant erythropoietic protein that     stimulates the production of red blood cells. This medication has not been approved to treat     cancer patients with anemia, however it has been approved by the FDA to treat chronic renal     failure patients with anemia.   "
168653|NCT00036036|"     The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in     locally advanced or metastatic renal cell cancer and to evaluate the safety profile of CP-461     in this patient population.   "
168654|NCT00036062|"     The purpose of this study is to determine whether sivelestat will reduce the amount of time a     patient must spend on a ventilator and/or increase the chance of survival of patients with     acute lung injury.   "
192013|NCT00359671|"     A study to evaluate safety and tolerability of MK6592 in combination with an anti-cancer drug     in adult patients with advanced solid tumors.   "
168660|NCT00036140|"     The primary goal of the study is to determine the best dose of an investigational drug to     give to patients with multiple myeloma and to evaluate the investigational drug's     effectiveness as a treatment for multiple myeloma.   "
168661|NCT00036153|"     The purpose of this study is to evaluate the efficacy of the combination of tacrolimus +     methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of     rheumatoid arthritis over 6 months in patients with partial response to methotrexate.   "
168662|NCT00036166|"     The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with     proven or probable invasive infections due to Aspergillus species.   "
168663|NCT00036179|"     The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of     patients with confirmed candidemia or invasive candidiasis.   "
168664|NCT00036192|"     The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic     subjects receiving sulfonylurea (SU) monotherapy.   "
168665|NCT00036205|"     The primary objective is to assess the long term safety and tolerability of sumanirole as     measured by safety labs, ECG monitoring, vital signs, and adverse event reports in subjects     with Parkinson's Disease who participated in previous sumanirole studies.   "
168666|NCT00036218|"     The primary purpose of this study is to determine whether sumanirole is effective and safe in     the treatment of the signs and symptoms of early Parkinson's disease.   "
168667|NCT00036231|"     The purpose of the study is to determine the effect of multiple doses of secretin on autism.   "
168668|NCT00036244|"     The purpose of the study is to determine whether multiple doses of secretin are safe and     effective in the treatment of children with autism.   "
168669|NCT00036257|"     The purposes of this study are to determine a maximum tolerated dose and to evaluate the     safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.   "
168670|NCT00036270|"     To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given     sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast     cancer.      This Pfizer sponsored trial is part of an international collaboration of investigators     conducting 7 similar yet independent studies in 9 countries. This study is designed to be     part of the larger TEAM trial where the data from these 7 studies will be combined. A     pre-specified analysis of the pooled data will be conducted.   "
168671|NCT00036283|"     Reduction in size and number of oral premalignant lesions   "
168674|NCT00036335|"     The purposes of this study are to determine whether an investigational drug can help patients     suffering from major depression with pain symptoms, and gather data on the safety of the     investigational drug including any side effects that might be associated with it.   "
168678|NCT00036387|"     The purpose of this study is to evaluate the safety and effectiveness of Infliximab     (Remicade) in patients with Rheumatoid Arthritis. Infliximab (Remicade) targets specific     proteins in the body's immune system to help control the development of inflammation to help     reduce the pain of rheumatoid arthritis.   "
168679|NCT00036400|"     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa on the     reduction in red blood cell transfusions needed in gastric cancer patients and rectal cancer     patients undergoing a treatment plan of preoperative chemotherapy and radiation therapy,     followed by surgery.   "
168680|NCT00036413|"     This study is the first to be performed in Amyotrophic Lateral Sclerosis (ALS) patients with     the novel compound TCH346. Its purpose is to evaluate the safety and clinical effects of 3     dose levels of TCH 346 compared to placebo in patients with a clinical diagnosis of     laboratory-supported probable, probable or definite ALS. The study will require patients to     visit the study center a total of at least 7 times over the course of up to 14 weeks. The     study consists of 2 phases: A screening phase (up to 2 weeks) when patients will be evaluated     for eligibility to participate in the study, and a double-blind treatment phase (12 weeks)     when patients will receive daily doses of either TCH346 or placebo and will be evaluated for     clinical effects. In addition, patients eligible to participate in this study will be     required to have 3 magnetic resonance spectroscopic (MRS) scans. The MRS is a non-invasive,     painless, brain scan. The MRS will require traveling to a designated center in Montreal,     Canada, which is very experienced in performing such MRS scans in ALS patients.   "
168681|NCT00036426|"     The purpose of this study was to determine if an idiotype vaccine, made from a patient's     lymphoma that has returned after chemotherapy and/or rituximab, would be able to shrink their     tumor.   "
168682|NCT00036439|"     The purpose of this study is to evaluate the effectiveness and safety of infliximab     (Remicade) in patients with Ulcerative Colitis.   "
168683|NCT00036452|"     Anti-HIV drug therapy works best when the drugs are taken exactly as prescribed by a doctor.     Because anti-HIV therapy often involves multiple drugs, some people have difficulty taking     them all correctly. The easier it is to take anti-HIV drugs, the more likely people will take     them as prescribed and get the best results. This study will see if people are more     successful in taking anti-HIV drugs once a day or twice a day. It also will determine if     having a health care professional oversee each weekday dose helps people control their HIV     infection. The study will compare taking a three-drug combination twice a day versus taking a     three-drug combination just once a day. The study will also compare patients taking the drugs     on their own to patients taking the drugs in the presence of a clinical worker. Viral load     (amount of HIV in the blood) and drug side effects will be measured.   "
168697|NCT00030654|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as     luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the     adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to     stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with     chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the     same time as hormone therapy is more effective than chemotherapy given after hormone therapy     in treating prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the     same time as hormone therapy with that of chemotherapy given after hormone therapy in     treating patients who have prostate cancer.   "
179529|NCT00186368|"     The purpose of this study is to investigate gene expression profiles and biologic features of     prostate tissue and how they relate to prostate cancer development and growth.   "
168684|NCT00036465|"     This study will look at people who have been taking anti-HIV drugs but still have detectable     levels of HIV. The purpose of the study is to find out what happens in those people who     change anti-HIV drugs when their viral load reaches 200 copies compared to those who change     anti-HIV drugs when their viral load reaches 10,000 copies. This study will also look at drug     resistance (how well HIV responds to drugs), viral fitness (how well drug-resistant HIV     copies itself), and immunologic reconstitution (how well the immune system recognizes various     infections, including HIV).      Many patients experience virologic relapse (increase in viral load after sustained viral load     suppression) within 1 to 2 years of taking anti-HIV drugs. The approach to treatment for     patients who experience virologic relapse while on a highly active antiretroviral therapy     (HAART) has not been defined. Current guidelines recommend switching to a new treatment     regimen as soon as possible to prevent HIV from becoming even more resistant to anti-HIV     drugs. However, there is evidence that patients can benefit from staying on the same HAART     drugs, even after virologic relapse. This study wants to find what happens when drugs are     changed immediately after virologic relapse (when the viral load is lower) compared to what     happens if drugs are changed only after a delay (when the viral load is higher).   "
168685|NCT00036478|"     The purpose of this study is to see if magnetic resonance spectroscopy (MRS) can be used to     detect damage to the mitochondria in HIV-infected patients taking nucleoside reverse     transcriptase inhibitor (NRTI) drugs.      HIV-infected patients taking NRTI drugs may have an increase in a chemical in their blood     called lactate. High lactate levels may damage the energy source of the cell (mitochondria).     Damage to mitochondria may cause lactic acidosis, liver failure, and other problems. It is     important to find effective ways to see if the mitochondria of HIV-infected patients have     been damaged. This study will see if MRS can be used to determine mitochondrial damage.   "
168686|NCT00036491|"     The purpose of this study is to determine the safety and effectiveness of rituximab     (anti-CD20) in treating systemic lupus erythematosus (SLE).      White blood cells in the body called B cells give off substances that are active in promoting     SLE disease. Researchers have found that anti-CD20 can block production of these substances     in another disease. This study explores whether anti-CD20 will also be safe in people with     SLE and whether it may be effective in treating SLE.   "
168687|NCT00036504|"     The purposes of this study are to determine: 1. If patients taking insulin lispro LM with     metformin will have better overall control of their blood sugar than patients taking a long     acting insulin comparator with metformin. 2. If there is a difference in the way the two     treatments affect blood sugar control before and after meals and at night. 3. If there is a     difference in the insulin dose required with the two treatments. 4. If there is a difference     in the numbers of times patients experience low blood sugar with the two treatments. 5. If     there is a difference in the effect on patients's body weight.   "
168688|NCT00036517|"     The triple combination chemotherapy of irinotecan, 5-fluorouracil and leucovorin     (CPT-11/5-FU/LV or Saltz regimen) is the treatment of choice for patients with advanced     colorectal cancer. Severe diarrhea, unfortunately, is a side effect of such treatment.     Preclinical studies have indicated that the botanical drug PHY906 can reduce such diarrhea     without compromising the effectiveness of the chemotherapy. The primary purpose of this     clinical study is to evaluate the safety, tolerability and minimum effective dose of PHY906     when administered in conjunction with the Saltz regimen.   "
168689|NCT00036543|"     This study is being done to evaluate the safety and efficacy of atrasentan in men with     metastatic hormone-refractory prostate cancer.   "
168690|NCT00036556|"     This study is being done to evaluate the safety and efficacy of atrasentan in men with     non-metastatic hormone-refractory prostate cancer.   "
168692|NCT00036582|"     The purpose of this study is to determine the safety and effectiveness of clozapine in     children and adolescents with treatment resistant bipolar disorder. This study will also     explore how the brain functions in early-onset bipolar disorder.   "
168693|NCT00036595|"     This study examines the relationship between a cerebral hemisphere and control of muscles on     the same side of the body (ipsilateral control). One good way to study this relationship is     to record electroencephalogram (EEG) activity directly from the cortical surface. Because     patients with epilepsy who are surgical candidates are already undergoing monitoring with     subdural and/or depth electrodes, they present an opportunity to study ipsilateral control.     Studying the electrocorticographic (ECoG) activity associated with simple voluntary movement     in such patients would not disturb ongoing monitoring of nearby areas of the brain, nor would     it endanger the patients.      Ten patients, who may be children or adults, will be recruited for this study. Brain activity     will be measured while they move the corner of their mouth and their fingers, wrists, arms,     and feet. The baseline measurements will be done with scalp electrodes. Once subdural     electrodes have been placed, a second set of measurements will be done. Surface EMG     electrodes will be placed on the muscles whose movements are being tested. The tests will be     done on no more than 3 separate days, in sessions no longer than 2 hours, for each patient.   "
168694|NCT00036608|"     The purpose of this clinical research study is to assess the safety and effectiveness of     switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.   "
168695|NCT00036621|"     This clinical trial will assess whether BMS-275291 can be administered safely in combination     with standard adjuvant therapy for early breast cancer and whether plasma concentrations at     trough exceed a target minimum.   "
168696|NCT00030641|"     RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor     cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of     docetaxel by making the tumor cells more sensitive to the drug. It is not yet known if     docetaxel is more effective with or without oblimersen in treating non-small cell lung     cancer.      PURPOSE: Randomized phase II/III trial to compare the effectiveness of docetaxel with or     without oblimersen in treating patients who have relapsed or refractory non-small cell lung     cancer that has been previously treated.   "
168698|NCT00030667|"     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have     relapsed or refractory solid tumors of childhood. Imatinib mesylate may stop the growth of     tumor cells by blocking the enzymes necessary for their growth.   "
179530|NCT00186381|"     Evaluate the role of high dose chemotherapy with autologous hematopoietic cell     transplantation for AML.   "
168699|NCT00030680|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients     who have aggressive fibromatoses.   "
168700|NCT00030693|"     Randomized phase I trial to compare the effectiveness of two different vaccines given     directly into the tumor in treating patients who have metastatic solid tumors. Vaccines may     make the body build an immune response to kill tumor cells. Infusing the vaccine directly     into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet     known which vaccine may be more effective in treating metastatic solid tumors   "
168701|NCT00030706|"     RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who     have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary     peritoneal cancer.   "
168702|NCT00030719|"     RATIONALE: Colony-stimulating factors such as filgrastim may increase the number of immune     cells found in bone marrow or peripheral blood and may help a person's immune system recover     from the side effects of chemotherapy. Combining chemotherapy with peripheral stem cell     transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more     tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Combining isotretinoin and     monoclonal antibodies may kill any remaining tumor cells following surgery. It is not yet     known which treatment regimen is more effective in treating neuroblastoma.      PURPOSE: This randomized phase III trial is studying how well combination chemotherapy with     or without filgrastim before surgery, high-dose chemotherapy, and radiation therapy followed     by isotretinoin with or without monoclonal antibody work in treating patients with     neuroblastoma.   "
168703|NCT00030732|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if gemcitabine is more effective with or     without capecitabine in treating pancreatic cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or     without capecitabine in treating patients who have advanced pancreatic cancer.   "
168704|NCT00030745|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so     that it can be removed during surgery.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have mesothelioma of the lung.   "
168720|NCT00043953|"     The objectives of this study are to explore the metabolic toxicities associated with     lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in     antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of     LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the     pharmacokinetics of 400 mg INV taken twice a day (BID), 600 mg INV BID and 800 mg INV BID in     combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine     BID.   "
168705|NCT00030758|"     RATIONALE: Colony-stimulating factors, such as filgrastim or pegfilgrastim, may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system recover from the side effects of chemotherapy. It is not yet known whether     filgrastim or pegfilgrastim is more effective than standard treatment in preventing     neutropenia in women who are receiving adjuvant chemotherapy for breast cancer.      PURPOSE: Randomized phase IV trial to compare the effectiveness of filgrastim or     pegfilgrastim with that of standard treatment in preventing neutropenia in women who are     receiving chemotherapy after undergoing surgery for breast cancer.   "
168706|NCT00030771|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed. It is not yet known if chemotherapy plus radiation therapy is more effective than     chemotherapy alone before surgery in treating non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying docetaxel and cisplatin with or without     radiation therapy to see how well they work when given before surgery in treating patients     with stage IIIA non-small cell lung cancer that has spread to lymph nodes in the chest.   "
168707|NCT00030784|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin with     ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma.   "
168708|NCT00030797|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy in     treating patients who have advanced or metastatic colorectal cancer.   "
168709|NCT00030810|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it     can be removed during surgery.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung     cancer.   "
168710|NCT00030823|"     RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of     breast cancer.      PURPOSE: Pilot trial to study the effectiveness of vaccine therapy in treating patients who     are at high risk for breast cancer recurrence.   "
168711|NCT00030849|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.     Combining chemotherapy with interferon alfa may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon     alfa in treating patients who have cutaneous T-cell lymphoma.   "
179531|NCT00186394|"     To evaluate the role of allogeneic hematopoietic cell transplantation in the treatment of     NHL.   "
168712|NCT00030862|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and cisplatin in     treating patients who have locally advanced unresectable or metastatic cancer of the     esophagus that has not been previously treated.   "
168713|NCT00030875|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary     for cancer cell growth.      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who     have previously untreated or relapsed mantle cell lymphoma.   "
168714|NCT00043875|"     This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to     the current therapy of pediatric patients age 1-24 months old with partial seizures. The     medication used in this study has been approved by FDA for the adjunctive treatment of     partial seizures in patients 2 years and older.   "
168715|NCT00043888|"     Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study     to test the safety and tolerability of fosamprenavir with or without ritonavir in combination     TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy.   "
168716|NCT00043901|"     The purpose of this study is to evaluate the effectiveness and safety of an investigational     new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC)     seizures.   "
168717|NCT00043914|"     This study includes patients 16 years of age or older with a confident diagnosis of epilepsy     who are currently treated with an antiepileptic drug (AED) monotherapy but require a change     in therapy due to inadequate seizure control and/or unacceptable side effects.   "
168718|NCT00043927|"     This study will gather and compare data about the effectiveness and safety of two different     treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received     previous chemotherapy. One treatment will use an investigational drug in combination with an     FDA approved chemotherapy. The other treatment will use a combination of two FDA approved     chemotherapy drugs.   "
168719|NCT00043940|"     Primary Objective:      To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with     new or previous heparin-induced thrombocytopenia (HIT) / heparin-induced thrombocytopenia and     thrombosis syndrome (HITTS) undergoing percutaneous coronary intervention (PCI). This will be     measured by the composite incidence of major bleeding events during administration or within     48 hours after stopping bivalirudin (or at hospital discharge, whichever occurs first). The     components of the composite endpoint are: a) intracranial bleeding; b) retroperitoneal     bleeding; c) bleeding that results in hemodynamic compromise; d) bleeding that requires     transfusion of three or more units of whole blood or packed red cells; and e) a decrease in     hemoglobin of greater than or equal to g/dL or in hematocrit of greater than or equal to 9%.      Secondary Objectives:      Each component of the primary composite endpoint.      To evaluate the level of anticoagulation achieved with bivalirudin. The goal is to achieve an     activated clotting time (ACT) between 300 and 350 sec during PCI and 4-hour bivalirudin     infusion.      To evaluate bivalirudin's effects on platelet counts.   "
168721|NCT00043966|"     The purpose of this study is to compare the safety, tolerability and antiviral activity     between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further     characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir.   "
168722|NCT00043979|"     This study will examine the safety and effectiveness of stem cell transplantation for     treating patients with sarcomas (tumors of the bone, nerves, or soft tissue). Stem cells are     immature cells in the bone marrow and blood stream that develop into blood cells. Stem cells     transplanted from a healthy donor travel to the patient's bone marrow and begin producing     normal cells. In patients with certain cancers, such as leukemia and lymphoma, the donor's     immune cells attack the patient's cancer cells in what is called a graft-versus-tumor     effect, contributing to cure of the disease. This study will determine whether this treatment     can be used successfully to treat patients with sarcomas.      Patients between 4 and 35 years of age with a sarcoma that has spread from the primary site     or cannot be removed surgically, and for whom effective treatment is not available, may be     eligible for this study. Candidates must have been diagnosed by the age of 30 at the time of     enrollment. They must have a matched donor (usually a sibling). Participants undergo the     following procedures:      Donors: Stem cells are collected from the donor. To do this, the hormone granulocyte colony     stimulating factor (G-CSF) is injected under the skin for several days to move stem cells out     of the bone marrow into the bloodstream. Then, the cells are collected by apheresis. In this     procedure the blood is drawn through a needle placed in one arm and pumped into a machine     where the stem cells are separated out and removed. The rest of the blood is returned to the     donor through a needle in the other arm.      Patients: For patients who do not already have a central venous catheter (plastic tube), one     is placed into a major vein. This tube can stay in the body the entire treatment period for     giving medications, transfusing blood, , withdrawing blood samples, and delivering the     donated stem cells. Before the transplant procedure, patients receive from one to three     cycles of induction chemotherapy, with each cycle consisting of 5 days of fludarabine,     cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone followed by at least a     17-day rest period. All the drugs are infused through the catheter except prednisone, which     is taken by mouth. After the induction therapy, the patient is admitted to the hospital for 5     days of chemotherapy with high doses of cyclophosphamide, melphalan, and fludarabine. Two     days later, the stem cells are infused. The anticipated hospital stay is about 3 weeks, but     may be longer if complications arise. Patients are discharged when their white cell count is     near normal, they have no fever or infection, they can take sufficient food and fluids by     mouth, and they have no signs of serious graft-versus-host disease (GVHD)-a condition in     which the donor's cells see the patient's cells as foreign and mount an immune response     against them.      After hospital discharge, patients are followed in the clinic at least once or twice weekly     for a medical history, physical exam, and blood tests for 100 days. They receive medications     to prevent infection and GVHD and, if needed, blood transfusions. If GVHD has not developed     by about 120 days post transplant, patients receive additional white cells to boost the     immune response. After 100 days, follow-up visits may be less frequent. Follow-up continues     for at least 5 years. During the course of the study, patients undergo repeated medical     evaluations, including blood tests and radiology studies, to check on the cancer and on any     treatment side effects. On four occasions, white blood cells may be collected through     apheresis to see if immune responses can be generated against the sarcomas treated in this     study. Positron emission tomography (PET) scans may be done on five occasions. This test uses     a radioactive material to produce images useful in detecting primary tumors and cancer that     has spread.   "
168723|NCT00043992|"     To examine the role of outdoor pollen grains and fungal spores in the exacerbation of asthma     and to produce forecasting models to predict days of high concentration.   "
168724|NCT00044005|"     The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with     schizophrenia.   "
168725|NCT00044018|"     The purpose of the study is to select the dose regimen of CDC-501 that provides the most     promising evidence of efficacy.   "
168726|NCT00044031|"     This study will test whether the G17DT Immunogen, when administered in combination with     chemotherapy, is an effective and safe treatment for pancreatic cancer.   "
168727|NCT00044044|"     The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a     placebo and to haloperidol in patients with schizophrenia.   "
168728|NCT00044057|"     The purpose of this study is to determine if YM872 in combination with t-PA can reduce     disability and brain damage from stroke. YM872 or placebo will be given as a continuous     intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or     placebo, is administered prior to the completion of the t-PA administration. The clinical     effects of YM872 in addition to t-PA will be determined by assessing neurological function     and disability scores at follow up visits through Day 90 of the study.   "
168729|NCT00044070|"     This study will investigate the effects of a potential neuroprotectant compound, YM872, in     the treatment of acute ischemic stroke. The study will determine if a 24-hour infusion of     YM872, given within 6 hours of stroke onset, reduces the ischemic lesion volume as measured     by MRI at 28 days after the infusion is given. The clinical effects of YM872 will also be     determined by neurological function and disability scores at follow up visits through Day 90     of the study.   "
168730|NCT00044083|"     This study will evaluate whether Tolcapone improves cognition in healthy volunteers as well     as patients with schizophrenia. Talcapone is a drug that has been FDA approved for Attention     Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the     frontal cortex of the brain.   "
168749|NCT00046371|"     The purpose of this study is to examine the immunological response rate to administration of     the THERATOPE® vaccine in women with stable metastatic breast cancer who are being treated     with aromatase inhibitors or Faslodex® and who do not require chemotherapy.      Post-menopausal women on aromatase inhibitors or Faslodex® alone and pre-menopausal women on     aromatase inhibitors plus luteinising hormone-releasing hormone (LH/RH)-agonist may be     eligible to be enrolled.      Patients must not have had radiotherapy or major surgery within four (4) weeks prior to     entering the study.      Information about the safety and tolerability of administration of the THERATOPE® vaccine     will also be gathered during the course of the study.   "
168750|NCT00046384|"     The purpose of this study is to learn if aripiprazole is effective in the treatment of     patients with acute symptoms of Bipolar Disorder.   "
168751|NCT00046397|"     This study will test the safety of an experimental vaccine called Modified Vaccinia Virus     Ankara (MVA) for use against the smallpox virus. It will also investigate how many injections     of MVA are needed to produce immunity against vaccinia virus, which is closely related to the     smallpox virus. An effective smallpox vaccine exists, but it can cause side effects that, on     rare occasions, can be life-threatening. The FDA gave new license approval for Dryvax on     10/25/02, but has not been used in the general population since smallpox was eradicated     worldwide. Both the MVA and Dryvax® (Registered Trademark) vaccines are made using the     vaccinia virus, however the MVA vaccine contains a more attenuated, or weakened, form of the     virus. [http://www.fda.gov/cber/products/smalwye102502.htm]      Healthy normal volunteers between 18 and 30 years of age, who have never been vaccinated with     a smallpox vaccine, may be eligible for this study. Candidates will be screened with a     medical history, physical examination, and blood and urine tests, including an HIV test and a     pregnancy test for women of childbearing potential.      MVA, placebo and Dryvax® (Registered Trademark) will be administered by different methods.     The MVA vaccine and placebo are injected into an arm muscle with a needle and syringe. The     Dryvax® (Registered Trademark) vaccine is administered, as it was for many years, with a     special forked needle that is poked lightly into the skin of the upper arm, usually 15 times,     in a process called scarification. When the vaccine works, a small pus-filled blister forms,     followed by a scab and then scarring at the site of the vaccination. The formation of the     blister and scab is called a take, indicating that the vaccine is effective and is evidence     of the development of immunity. The development of a take suggests that an individual will be     protected against smallpox for at least a few years. If scarification does not take, it can     either mean that the person already has immunity or that the vaccine did not work.      Participants will be assigned to groups, as well as, product randomly. For instance, the     first study participant could be enrolled into group 3. The Dryvax® (Registered Trademark)     dose is given as a challenge to see if the person has a take. A reduced take response or no     take, could suggest that MVA is able to produce an immune response. The dosing schedules vary     from 12 to 24 weeks and volunteers are in the study a total of 24 to 36 weeks, depending on     the number of injections.      Participants will be observed for at least 1 hour after each injection. They will come to the     clinic a week after MVA or placebo injections and at least twice a week after Dryvax®     (Registered Trademark) for about 21 days to have the injection site evaluated and     photographed. At each visit, participants will be asked about how they are feeling and if     they are taking any medications. Blood and urine tests will be done on injection days and at     follow up visits scheduled 1 and 4 weeks after each immunization as well as 12 weeks after     the Dryvax® (Registered Trademark) challenge dose. Additional tests may be done between     visits if medically necessary.   "
168731|NCT00044096|"     The purpose of this study is to understand the effects of the drug alprazolam (Xanax ) on     anxiety.      To understand the effect of anxiety-relieving drugs on fear and anxiety, researchers often     have participants anticipate unpleasant stimuli. Anticipating unpleasant stimuli increases or     potentiates a simple reflex called the startle reflex. The so-called fear-potentiated startle     reflex (FPS) effect may be blocked or reduced by anxiety-relieving drugs. Evidence suggests     that the FPS can be mediated by two mechanisms that regulate the phasic- and sustained     enhancement of startle. This study will elicit phasic and sustained FPS in participants by     having them anticipate moderately painful stimuli that are administered predictably and     unpredictably. The main goal of this study is to assess the affect of alprazolam on the     phasic and sustained enhancement of startle.      This study comprises two pilot experiments and a main study. Participants in the study will     be screened with a psychiatric history, physical examination, electrocardiogram (EKG), and     blood and urine tests. Participants will four testing sessions separated by 5 to 10 days. At     each session, participants will be given one of two doses of alprazolam, diphenhydramine, or     placebo (an inactive pill). Questionnaires and other tests will be performed.   "
168732|NCT00044109|"     Despite much popularity among the public, magnetic devices used for the treatment of various     musculoskeletal and neuropathic pain syndromes have been the subject of few randomized     controlled trials.      We propose to study the effects of permanent 200 gauss magnets on lumbar radicular pain. This     study will include 52 men and women of all ethnic backgrounds between the ages of 28 and 75     who have had signs and symptoms of sciatica for 3 months or more.      This is a double-blind, randomized, placebo-control, two phase study. In the first phase,     after one week baseline, subjects will be randomized to 4 different treatments in a     cross-over design. These 4 treatments which will last two weeks each are: 1 magnetic device     positioned in 2 different ways along the spinal axis (up-down along the lumbo-sacral spine     and left-right across the lumbo-sacral spine), a sham device of similar configuration and a     no treatment control. The length of phase I will be 8 weeks. At the end of this phase, codes     will be broken to select the magnetic device associated with the greatest amount of pain     score reduction. During the second phase which will also be double-blinded, subjects will be     randomized to wear the selected magnetic device and sham in a cross-over design. Each of the     2 periods will be 5 weeks in duration. The primary outcome measures will be the daily pain     score in the leg. Daily pain level in the low back and the back and leg combined in addition     to the patients' quality of life and activities of daily living will be secondary outcome     measures as assessed by the SF 36, Oswestry, and Beck depression inventory.   "
168733|NCT00044122|"     This study will examine growth factors that promote and inhibit mast cell proliferation     resulting in mastocytosis, a disease of excessive mast cells in the body. These cells can     release chemicals that cause itching, blisters, flushing, bone pain and abdominal pain.      Patients up to 80 years of age with mastocytosis may be eligible for this 1-day study.     Participants will have one visit at NIH lasting up to 8 hours, during which they will undergo     the following tests and procedures:        -  Medical history and physical examination.        -  Laboratory studies, if medically indicated.        -  Blood tests to identify genetic changes important in the growth, development, and          functioning of mast cells.        -  Bone marrow aspiration and biopsy.      For the bone marrow procedure, the skin over the hipbone and the outer surface of the bone     itself are numbed with local anesthesia. Then, a special needle is inserted into the hipbone     and about 1 tablespoon of bone marrow is drawn into a syringe. Another needle is inserted     into the same area to collect a small piece of the bone marrow. Additional procedures may     include allergen testing, urinalysis, and 24-hour urine collection.      Participants will receive an evaluation of their mastocytosis.   "
168734|NCT00044135|"     The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment     with clevudine, at one of three doses, in patients chronically infected with hepatitis B     virus.   "
168735|NCT00044148|"     The purpose of this study are to determine 1) Whether Ly333531 can reduce urinary     albumin/creatinine excretion in patients with Type II diabetes and persistent albuminuria 2)     Whether LY333531 reduces urinary TGF-B, 3) the safety of LY333531 and any side effects that     may be associated with it.   "
168736|NCT00044174|"     This study will examine 1) differences among mothers behaviors and how these behaviors     influence their infants reactions, and 2) how mother-child interactions relate to children s     temperament, and cognitive (thought processing) abilities, and other areas of development.      Depressed and non-depressed English-speaking mothers between 20 and 45 years of age, with an     infant 4 months or younger, may be eligible for this study. Candidates will be screened with     a mailed survey regarding their moods and feelings. Participants will undergo the following     procedures:        -  Psychiatric Interview: Subjects will participate in a 30-90 minute interview consisting          of a series of standardized questions about the their behaviors and feelings.          Participants whose interviews suggest a condition that may impact their mental health          will be referred to the study clinician for follow-up to confirm or clarify the          preliminary findings. Continued participation in the study will be determined following          this.        -  Home Visit: A study investigator will visit the home for 1 hour to film the mother and          baby during the mother s typical daily activities. This visit will take place when the          baby is about 5 months old. At the end of the visit, the mother will be given a variety          of surveys to fill out at home and return at the next visit (see Lab Visit below). The          survey questions deal with the mother s relationship with her partner, support from          people in her life, typical behaviors of her infant, and how often she feels certain          emotions. A packet of surveys will also be left for the participant s partner to          complete and mail back to the investigator. The partner may or may not be the child s          biological father and may or may not choose to participate in the study.        -  Lab Visit: Within 1 week of the home visit, the mother and child will come to the NICHD          clinic for about 2 hours. During this time, the mother will return the previous surveys          and fill out another one regarding her current mood. She will then interact with her          child, who will be seated in front of her. The 20-minute session will be videotaped.          (There will be breaks during the session.) The mother will be instructed about how she          should act (happy or sad). She and her baby will then participate in a variety of filmed          situations that will induce certain emotions in the baby, such as happiness, fear,          activity, frustration, and interest, in order to learn how different children react to          different situations.      Participants will be contacted to continue the study when their babies are 12 months old and     again when the children are 24 months old. The above procedures will be repeated and some new     measures will be added for toddlers that involve activities investigating aspects of early     language and social reasoning..   "
168737|NCT00044187|"     Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes     with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of     obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight     gain that may be associated with taking olanzapine.      The purposes of this study are to determine the safety of olanzapine when given in     combination with the Anti-obesity Agent and any side effects that might be associated with it     and whether weight-gain agent can help treat weight gain that may be associated with taking     olanzapine.   "
168781|NCT00046787|"     The purpose of this study is to determine whether OSI-211 (Liposomal Lurtotecan) is an     effective and safe treatment for patients with recurrent small cell lung cancer.   "
168738|NCT00044200|"     This study uses positron emission tomography (PET) to examine brain function and signaling     involving phospholipids, and to see how signaling is related to blood flow. Much of the brain     is composed of fatty molecules called phospholipids. These molecules are involved in the way     brain cells signal each other to direct brain function. Brain disease may change     phospholipids and disturb brain structure and signaling. Studies of brain phospholipid     composition and metabolism may help clarify how the brain works in healthy people or stops     working effectively in disease states.      Healthy volunteers between 18 and 45 years of age may be eligible for this study. Candidates     are screened with a medical history, physical examination, and blood and urine tests.     Participants undergo magnetic resonance imaging (MRI) and PET scanning as follows:      MRI      MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For     this procedure, the subject lies on a table that is moved into a metal cylinder (the scanner)     and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning     process. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45     and 90 minutes. Subjects may be asked to lie still for up to 30 minutes at a time.      PET      For the PET scan, a catheter (thin plastic tube) is inserted into an artery in the subject's     wrist or elbow crease to collect blood samples during the procedure, and a second catheter is     placed in a vein in the opposite arm to inject radioactive tracers. The subject lies on the     scanner bed, wearing a special facemask and goggles. The mask helps hold the head still     during the scans, and the goggles either block all light or administer bright flashing     lights. Radioactive water is injected into the vein, followed by a 1-minute PET scan to     measure brain blood flow. This is repeated three more times. Then, a radioactive fatty acid     is injected into the vein, followed by a 1-hour PET scan to measure brain phospholipid     metabolism. This is repeated once. The images of blood flow and phospholipid metabolism in     the different regions of the brain under the conditions of darkness and during visual     stimulation provide information on how and where the brain responds to visual stimulation.     The entire procedure takes about 3 hours.   "
168739|NCT00044213|"     The purpose of this study is to determine the safety and effectiveness of ethylene diamine     tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.   "
168740|NCT00046254|"     The purpose of this study is to evaluate whether zoledronic acid given once yearly for two     years to men and women after surgical repair of a recent hip fracture will significantly     reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive     vitamin D and calcium.   "
168741|NCT00046267|"     The purpose of this study is to evaluate the safety, efficacy, and tolerability of     extended-release niacin (Niaspan) in improving the level of fats in the blood of HIV-infected     patients.   "
168742|NCT00046280|"     This is a comprehensive observational study of HIV infection in homosexual and bisexual men.   "
168743|NCT00046293|"     This study will determine the dose of Retavase that can safely be combined with ReoPro in     treating acute ischemic stroke (stroke resulting from a blood clot in the brain). ReoPro and     Retavase are currently approved by the Food and Drug Administration to treat heart problems     caused by blockage of heart arteries. The only therapy approved by the Food and Drug     Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment is     effective only if begun within 3 hours of onset of the stroke, however, and most patients do     not get to the hospital early enough to benefit from it.      Patients between 18 and 80 years of age who have had a mild or moderate acute stroke between     3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be     screened with a medical history and physical examination, blood tests, rating of neurological     deficits such as cognition deficits or problems walking that resulted from the stroke, and a     computed tomography (CT) scan of the head. CT involves the use of specialized X-rays to     obtain images of the brain. The patient lies on a table that is moved into a cylindrical     machine (the scanner) for the imaging study, which usually takes about 5 to 10 minutes.      All participants will receive 0.25 mg/kg of ReoPro (maximum dose of 30 mg). The drug is     infused into the vein over 12 hours. Some patients will also receive one of four doses of     Retavase, which may boost the effectiveness of ReoPro in opening the blocked blood vessel.     Retavase is given through a needle in the vein over 2 minutes. Patients will be monitored     daily until discharge from the hospital, or until day 5, whichever is earlier. Assessments     will include physical examinations, blood tests to examine factors involved in blood     clotting, and CT scans to evaluate both the response to treatment and drug side effects. They     will return for a follow-up examination and CT scan 30 days after treatment.   "
168758|NCT00046488|"     To determine what side effects and what clinical effects if any the administration of this     investigational product, IDEC-152 (an antibody against CD23 which is an important protein on     leukemia cells and certain cells in the body's immune system), has on the CLL patient     population.   "
168759|NCT00046501|"     The purpose of the study is to compare the effect in blood sugar control between Lantus and     twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a     multiple daily injection setting with fast acting insulin (Lispro)   "
168826|NCT00047463|"     The purpose of this trial is to work out design issues prior to conducting a definitive phase     3 trial to determine whether treating sleep-related breathing disorders in people with     epilepsy results in improvement in seizure control or an improvement in alertness during the     day.   "
168744|NCT00046306|"     Workplace exposure to secondhand cigarette smoke or environmental tobacco smoke (ETS)is     widespread, effecting between 19 and 49% of the U.S. workforce. The first part of this study     is designed to test whether exposure to ETS in the workplace effects a person's risk of     developing chronic diseases such as cardiovascular disease and cancer. The second part of     this study is designed to test whether antioxidant supplementation in this group of ETS     exposed individuals can reduce their risk of developing chronic disease.      The study will look at 375 non-smokers who either work on a casino floor or as bartenders or     cocktail servers. Initial baseline data will be collected (questionnaires and blood samples     taken) and the subjects will be randomized into one of three groups, placebo, low antioxidant     supplementation and high antioxidant supplementation. They will be followed over a two-year     period, coming in for follow-up testing every six months. Statistical analysis will be     conducted to see whether this group of ETS exposed individuals has a greater risk of     developing chronic disease and whether the use of antioxidant supplements can moderate any     risks.   "
168745|NCT00046319|"     The purpose of this study is to determine if treating patients suffering from moderate to     severe pulmonary arterial hypertension with BSF 208075 will improve the patients' ability to     exercise.   "
168746|NCT00046332|"     This study will evaluate the drop in viral load over 10 days of treatment with S-1360 versus     placebo in HIV-infected patients who have not previously taken anti-HIV medications.   "
168747|NCT00046345|"     The purpose of this clinical research study is to provide atazanavir to patients infected     with human immunodeficiency virus (HIV) whose antiviral medications are no longer working to     control HIV activity within the body and who are unable to create a new treatment regimen     using other available anti-HIV drugs, because of either side effects or treatment failure     previously taken. The safety of this treatment will also be studied.   "
168748|NCT00046358|"     The purpose of this study is to determine whether short-term use of the drugs ibuprofen and     lovastatin affects levels of a protein called beta-amyloid in people who are at risk for     developing Alzheimer's Disease (AD).   "
168782|NCT00046800|"     The purpose of this study is to estimate the efficacy and safety of OSI-211 and topotecan in     patients with relapsed epithelial ovarian cancer.   "
168752|NCT00046410|"     This study will compare the safety of coronary artery bypass grafting (CABG) with and without     the use of heart-lung bypass during surgery (on- versus off-pump surgery). CABG carries a     risk of stroke and of cognition problems (problems with thought processes) that may be caused     by small strokes. This study will use magnetic resonance imaging (MRI) to determine whether     the newer technique of off-pump CABG carries a lower risk of stroke than on-pump CABG. The     study will also evaluate the relative risk (the risk of stroke in CABG patients exposed to     the following factors compared to CABG patients who are not exposed to the following factors)     of other factors for stroke and cognitive problems, such as atherosclerosis (hardening of the     arteries), age, sex, pre-surgery intellectual function and performance, previous stroke,     chronic kidney failure, diabetes, high blood pressure, carotid artery disease (narrowing of     the neck arteries to the brain), peripheral blood vessel disease, and micro embolism (tiny     blood clots that travel to the brain).      Patients 18 years of age and older with chest pain or narrowing of the coronary arteries who     are scheduled to undergo CABG surgery may be eligible for this study.      Participants will be randomly assigned to have CABG either on-pump or off-pump. They will     undergo the following tests and procedures:        -  Tests of cognitive and neurological function before surgery and 6 months after surgery        -  Blood tests to look for cytokines (substances that indicate inflammation) before          surgery, immediately after surgery and 1 day after surgery        -  MRI scans to detect stroke before surgery, 1 day after surgery and 1 month after          surgery.      MRI is a diagnostic test that uses a strong magnetic field and radio waves to show structural     and chemical changes in tissue. For the procedure, the patient lies on a table that slides     into the scanner-a metal cylinder surrounded by a magnetic field. Earplugs are worn to muffle     the loud knocking sounds that occur when the pictures are being taken. The scan, taken before     surgery, will last about 20 minutes; the two after surgery take about 10 minutes to perform.   "
168753|NCT00046423|"     This trial will treat patients with advanced (metastatic) cancer with a new chemotherapeutic     agent that may be more readily tolerated than some standard therapies. Patients will be given     the new chemotherapeutic medicine once a week, by intravenous route, for three weeks,     followed by a rest week. Treatment will be repeated in four week cycles if the patient     improves on the therapy, and if there are no adverse events that require withdrawal of     medication.   "
168754|NCT00046436|"     This study will look at how well the OraQuick HIV 1/2 Antibody rapid test works and how women     accept being tested for HIV late in pregnancy and during labor. For women with positive test     results, the study will look at whether or not these women accept anti-HIV drugs and which     drugs they receive.   "
168755|NCT00046449|"     A Placebo Controlled Study Evaluating The Effectivess Of Medication In Preventing Seasonal     Affective Disorder   "
168756|NCT00046462|"     The purposes of the study is to determine whether blood sugar control is different between     Lantus and a third oral anti-diabetic agent when added to patients who fail a     thiazolidinedione and sulfonylurea or metformin combination.   "
168757|NCT00046475|"     We are seeking male and female patients to voluntarily take part in a clinical research     study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic     hypotension (low blood pressure while in the upright position) due to Parkinson's disease,     multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic     orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness,     changes in vision and generalized weakness upon standing. The main effect of the drug being     studied is to increase blood pressure in the upright position so symptoms will decrease.      The purpose of this clinical study is to further assess the clinical benefit of midodrine     hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the     course of the study, participants will receive either ProAmatine® or a placebo. Assessments     will be made using questionnaires that measure symptom and activity levels. Blood pressure in     the lying down and standing positions will be measured at each visit.   "
168822|NCT00047411|"     To compare home use of an automatic external defibrillator (AED) to the use of local     emergency medical system in treating survivors of sudden cardiac arrest.   "
168760|NCT00046514|"     The anticancer agent paclitaxel (marketed as Taxol) has shown remarkable activity against     metastatic breast cancer. However, the Taxol formulation requires prolonged administration     times, and there are safety problems that have been attributed to the solvent rather than the     active ingredient, paclitaxel. This is a new formulation of paclitaxel that has been found to     have fewer safety problems than Taxol, and may be administered safely at higher doses. This     study will investigate the safety and efficacy of this new formulation of paclitaxel given     intravenously once a week for three weeks, followed by a rest week. This cycle will be     repeated until safety problems or treatment failure require that the patient stop therapy.   "
168761|NCT00046527|"     Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against     metastatic breast cancer, as well as other cancers. Because the Taxol formulation of     paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol,     prolonged intravenous administration times are required; and because the solvent has caused     hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer     medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a     protein-stabilized material that is suspended in salt water and administered intravenously.     The time of administration is reduced, the dose of paclitaxel can be higher than is safe for     Taxol, and there is no premedication required.      This study will determine the efficacy of this new formulation of paclitaxel, as compared to     Taxol, for patients with metastatic breast cancer.      This is an open label comparative study, so patients will be randomly assigned to receive     either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are     receiving. Treatment will be repeated every three weeks unless adverse events or treatment     failure require discontinuing study medication.   "
168762|NCT00046540|"     Liposome Encapsulated SN38 (LE-SN38) is an oncology drug product consisting of the active     metabolite of irinotecan (CPT-11), a known anticancer drug, encapsulated in a liposome.     Formulation of a relatively insoluble compound (SN38) and improvement in drug delivery     (pharmacodynamic profile) may be obtained with liposomal formulations. An improved safety and     efficacy profile, compared with the pro-drug CPT-11, may be possible. This rationale is     supported by the results from animal toxicity studies in both the mouse and dog.      LE-SN38 will be infused intravenously every 3 weeks to assess safety and tolerability of     study drug until there is disease progression or toxicity requiring early treatment     discontinuation. Disease status will be assessed after every second cycle of treatment. In     the event of disease progression, study treatment will be discontinued, all end-of-treatment     study evaluations will be performed and further treatment options will be reviewed.   "
168783|NCT00046813|"     The purpose of this study is to test the use of High-Dose versus Regular-Dose Nicotine Patch     for Nicotine Dependence in Individuals with Schizophrenia or Schizoaffective Disorder   "
179532|NCT00186407|"     To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for     amyloidosis.   "
168763|NCT00046553|"     The purpose of this study is to examine the function of cortisol receptors in post-traumatic     stress disorder (PTSD).      Patients with PTSD have neurobiological dysregulation of the hypothalamic-pituitary-adrenal     (HPA) axis function. High corticotrophin releasing hormone (CRH) levels and decreased     hippocampal volume are major features of the disorder. The mechanisms responsible for these     alterations are not known. This study will evaluate the function of cortisol receptors to     determine their roles in maintaining PTSD HPA axis dysregulation. Three groups of subjects     will take part in the study: Patients with PTSD, healthy control subjects who were exposed to     trauma in the past and remained healthy and healthy control subjects who were never     traumatized      At study entry, the cerebral spinal fluid (CSF) of all participants will be sampled and     evaluated. Participants will also undergo a magnetic resonance imaging (MRI) scan of the     brain as well as eye blink trace conditioning and neuropsychological tests.      Participants will be admitted to the Clinical Center for two nights on three different     occasions. At each overnight visits, blood levels of stress hormones will be measured every     hour for 26 hours after medication or placebo are given. This will be the end of the study     for both groups of healthy control subjects, with the exception that they may be asked to     repeat neuropsychologic and eye blink tests after 12 weeks.      Participants with PTSD will receive paroxetine for 10 weeks. After 10 weeks these     participants will be reevaluated in exactly the same way as before treatment (except they     will not repeat the MRI scan).   "
168764|NCT00046566|"     The purpose of this study is to examine the effect of dietary protein supplements on high     blood pressure (BP).   "
168765|NCT00046579|"     To better understand the determinants of nutrient intake in black and white adolescent girls     and to examine the effects of nutrient intake and eating behaviors on obesity, a significant     risk factor for CVD.   "
168766|NCT00046592|"     To determine the mechanisms by which atherosclerotic peripheral artery disease (PAD) causes     functional impairment and to define the degree to which peripheral artery disease associated     pathophysiologic findings change over time.   "
168767|NCT00046605|"     To examine the associations of common variation in inflammation/thrombosis genes with     intermediate quantitative phenotypes and subclinical coronary atherosclerosis in the Coronary     Artery Risk Factor Development in Young Adults (CARDIA) Study, a large, bi-racial cohort     study.   "
168768|NCT00046618|"     To identify new dilated cardiomyopathy genes by genetic linkage and mutational analyses.   "
168769|NCT00046631|"     To investigate the role of community characteristics in physical activity levels of     adolescent girls.   "
168770|NCT00046644|"     To elucidate the mechanisms underlying inter-patient variation in response to montelukast, a     drug for asthma.   "
168771|NCT00046657|"     To examine how neighborhood-level factors interact with individual characteristics to predict     incidence of cardiovascular disease and all-cause mortality.   "
168772|NCT00046670|"     To examine the relationship between obstructive sleep apnea and lipid metabolism.   "
168773|NCT00046683|"     This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus     chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia     (B-CLL). Eligible patients must have previously untreated, Rai stage I-IV disease, and be     experiencing progression of their B-CLL requiring treatment. Patients who meet all     eligibility criteria may be randomized on a 1:1 basis to receive either Campath or     chlorambucil. An estimated 284 patients (142 per treatment arm) from approximately 40 or more     investigational sites will be randomized to one of the two treatment arms.   "
168774|NCT00046696|"     A study for patients who have failed standard therapy. If there is no dose limiting     toxicities the patients will receive further cycles of therapy if there is no evidence of     disease progression.   "
168775|NCT00046709|"     To find out if it is safe and effective to use smoked marijuana in combination with opioids     to treat cancer pain. The study will evaluate whether smoked marijuana, when used with     opioids, will have an effect on pain relief, and to see if marijuana reduces the side effects     of opioids, which include nausea and/or vomiting.   "
168776|NCT00046722|"     To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral     neuropathy.   "
168777|NCT00046735|"     To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week     cycle in patients with solid tumors that are refractory after standard treatment.   "
168778|NCT00046748|"     The purpose of this study is to determine the effect of omalizumab, compared to placebo, on     clinically significant asthma exacerbation rates in adolescents and adults with asthma.   "
168779|NCT00046761|"     The primary objective of this study is to compare the efficacy of ONO-2506 versus placebo in     neurological stroke outcome in patients with acute ischemic stroke.   "
168780|NCT00046774|"     This study will examine the safety and effects of the monoclonal antibody MRA in patients     with systemic lupus erythematosus (SLE). Antibodies normally fight invading organisms. In     autoimmune diseases, such as lupus, however, antibodies attack the body s own tissues. MRA is     an antibody manufactured in the laboratory that blocks the action of interleukin-6 (IL-6), a     substance that increases antibody production and is involved in inflammation that may cause     organ damage in SLE.      Patients 18 years of age and older with moderately active systemic lupus erythematosus may be     eligible for this 6-month study. Candidates will be screened with blood and urine tests,     chest X-ray, electrocardiogram (EKG), and screening tests for certain cancers.      Participants will receive a total of up to seven infusions of MRA given every 2 weeks in the     clinic. The MRA is infused over a period of about 1 hour through a catheter (thin plastic     tube) inserted into an arm vein. Patients will be observed for 1 to 2 hours after each     infusion for drug side effects. For the first and last infusions, patients will return to the     clinic for blood tests 24 to 48 hours after the infusion. Additional tests may be done if     medically indicated.      Three different doses of MRA will be used in three groups of patients. The first group (4     patients) will receive the lowest dose. If this dose is well tolerated, a second group (6     patients) will receive a higher dose. If this dose is also well tolerated, a third group (6     patients) will receive the highest study dose.      Patients will be evaluated at various intervals for up to 3 months after the last dose of     MRA. The follow-up visits will include a review of the patient s medical history, a physical     examination, blood and urine tests, and an EKG.   "
168784|NCT00046826|"     RATIONALE: Thalidomide may stop the growth of prostate cancer by stopping blood flow to the     tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with thalidomide may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and estramustine     with thalidomide in treating patients who have prostate cancer previously treated with     hormone therapy.   "
168785|NCT00046839|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may     stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor     cells more sensitive to radiation therapy.      PURPOSE: Phase I/II trial to study the effectiveness of combining celecoxib with radiation     therapy in treating patients who have locally advanced non-small cell lung cancer.   "
168786|NCT00046852|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with autologous peripheral stem cell     transplantation and immunotherapy may allow the doctor to give higher doses of chemotherapy     drugs and kill more cancer cells. Biological therapies use different ways to stimulate the     immune system and stop cancer cells from growing.      PURPOSE: Randomized phase I/II trial to study the effectiveness of combining chemotherapy     with peripheral stem cell transplantation followed by immunotherapy in treating patients who     have multiple myeloma.   "
168787|NCT00046865|"     RATIONALE: Acupressure may help to reduce or prevent nausea in patients who are undergoing     chemotherapy. It is not yet known whether acupressure plus standard care for nausea is more     effective than standard care alone for nausea in women who are receiving chemotherapy for     breast cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of acupressure in treating     nausea in women who are receiving combination chemotherapy for breast cancer.   "
168788|NCT00046878|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. O(6)-benzylguanine may increase the effectiveness of carmustine by     making tumor cells more sensitive to the drug.      PURPOSE: Phase II trial to study the effectiveness of combining carmustine with     O(6)-benzylguanine in treating patients who have newly diagnosed supratentorial glioblastoma     multiforme.   "
168789|NCT00046891|"     RATIONALE: Chemotherapy may cause memory loss, attention loss, and other problems that make     it difficult for patients to think clearly. EGb761 may help maintain mental clarity in     patients undergoing chemotherapy.      PURPOSE: Randomized clinical trial to study the effectiveness of EGb761 in preventing loss of     mental clarity in women who are receiving chemotherapy for newly diagnosed breast cancer.   "
168790|NCT00046904|"     RATIONALE: Etanercept is a substance that is being studied as a treatment for cachexia     (weight loss) and anorexia (lack of appetite) in patients who have cancer. It is not yet     known whether etanercept is effective in improving cancer-related cachexia and anorexia.      PURPOSE: Randomized phase III trial to determine the effectiveness of etanercept in treating     cancer-related cachexia and anorexia in patients who have advanced cancer.   "
168823|NCT00047424|"     To compare aggressive lowering of low density lipoprotein (LDL) cholesterol and blood     pressure to the usual care standard in Native American diabetics.   "
168791|NCT00046917|"     Phase I trial to study the effectiveness of combining alvocidib, irinotecan hydrochloride,     and cisplatin in treating patients who have advanced solid tumors. Drugs used in chemotherapy     use different ways to stop tumor cells from dividing so they stop growing or die. Combining     more than one drug may kill more tumor cells.   "
168792|NCT00046930|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Zosuquidar trihydrochloride, a modulator of multidrug resistance     (MDR), may help daunorubicin and cytarabine kill more cancer cells by making cancer cells     more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more     effective with or without zosuquidar trihydrochloride in treating acute myeloid leukemia or     anemia.      PURPOSE: This randomized phase III trial is studying how well giving zosuquidar     trihydrochloride together with daunorubicin and cytarabine works compared to daunorubicin and     cytarabine alone in treating older patients with newly diagnosed acute myeloid leukemia or     anemia that has not responded to previous treatment.   "
168793|NCT00046943|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients     who have prostate cancer that has not responded to hormone therapy.   "
168794|NCT00046969|"     RATIONALE: Epoetin beta may stimulate red blood cell production to prevent or control anemia     in patients treated with chemotherapy and radiation therapy.      PURPOSE: Randomized phase IV trial to determine the effectiveness of epoetin beta in treating     anemia in patients who are receiving cisplatin and radiation therapy for stage IIB, stage     III, or stage IVA cervical cancer.   "
168795|NCT00046995|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which schedule of chemotherapy is most     effective in treating colon cancer.      PURPOSE: Randomized phase III trial to compare different schedules of chemotherapy using     carboplatin with fluorouracil and leucovorin in treating patients who have stage IIB or stage     III colon cancer.   "
168796|NCT00047008|"     RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving     radiation therapy in different ways and combining it with chemotherapy before surgery may     kill more tumor cells. It is not yet known which radiation therapy regimen combined with     chemotherapy with or without surgery is more effective for head and neck cancer.      PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens     combined with cisplatin with or without surgery in treating patients who have stage III or     stage IV head and neck cancer.   "
168797|NCT00047021|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone     in treating patients who have recurrent or refractory leukemia or lymphoma.   "
168798|NCT00047034|"     Phase I trial to study the effectiveness of E7389 in treating patients who have advanced     solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing     so they stop growing or die   "
168799|NCT00047047|"     This phase I trial studies the side effects, best way to give, and best doses of tanespimycin     with or without gemcitabine hydrochloride and cisplatin in treating patients with advanced     solid tumors. Drugs used in chemotherapy, such as tanespimycin, gemcitabine hydrochloride,     and cisplatin, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Using more than one drug (combination     chemotherapy) may kill more tumor cells.   "
168800|NCT00047060|"     This study will investigate the safety and effectiveness of a modified donor stem cell     transplantation procedure for treating advanced mycosis fungoides (MF), a lymphoma primarily     affecting the skin, and Sezary syndrome (SS), a leukemic form of the disease. Donated stem     cells (cells produced by the bone marrow that mature into the different blood components     white cells, red cells and platelets) can cure patients with certain leukemias and lymphomas     and multiple myeloma. These cells generate a completely new, functioning bone marrow. In     addition, immune cells from the donor grow and generate a new immune system to help fight     infections. The new immune cells also attack any residual tumor cells left in the body after     intensive chemotherapy. However, stem cell transplantation carries a significant risk of     death, because it requires completely suppressing the immune system with high-dose     chemotherapy and radiation. In addition, lymphocytes from the donor may cause what is called     graft vs. host disease (GvHD), in which these cells see the patient s cells as foreign and     mount an immune response to destroy them. To try to reduce these risks, patients in this     study will be given low-dose chemotherapy and no radiation, a regimen that is easier for the     body to tolerate and involves a shorter period of complete immune suppression. In addition, a     monoclonal antibody called Campath-1H will be given to target lymphocytes, including those     that have become cancerous.      Patients with advanced MF or SS who are between 18 and 70 years of age and have a matched     family donor 18 years of age or older may be eligible for this study. Candidates will have a     medical history, physical examination and blood tests, lung and heart function tests, X-rays     of the chest, eye examination, and bone marrow sampling (withdrawal through a needle of about     a tablespoon of marrow from the hip bone), and small skin biopsy (surgical removal of a piece     of tissue for microscopic examination) or needle biopsy of the tumor.      Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF     will be injected under the skin for several days to push stem cells out of the bone marrow     into the bloodstream. Then, the stem cells will be collected by apheresis. In this procedure     the blood is drawn through a needle placed in one arm and pumped into a machine where the     required cells are separated out and removed. The rest of the blood is returned through a     needle in the other arm.      Before the transplant, a central venous line (large plastic tube) is placed into a major     vein. This tube can stay in the body and be used the entire treatment period to deliver the     donated stem cells, give medications, transfuse blood, if needed, and withdraw blood samples.     Several days before the transplant procedure, patients will start a conditioning regimen of     low-dose chemotherapy with Campath 1H, fludarabine, and, if necessary, cyclophosphamide. When     the conditioning therapy is completed, the stem cells will be infused over a period of up to     4 hours. To help prevent rejection of donor cells and GvHD, cyclosporine and mycophenolate     mofetil will be given by mouth or by vein for about 3 months starting 4 days before the     transplantation.      The anticipated hospital stay is 3 to 4 days, when the first 3 doses of Campath will be     monitored for drug side effects. The rest of the procedures, including the transplant, can be     done on an outpatient basis. Follow-up visits for the first 3 months after the transplant     will be scheduled once or twice a week for a physical examination, blood tests and symptoms     check. Then, visits will be scheduled at 6, 12, 18, 24, 30, 36, and 48 months     post-transplant. Visits for the first 3 years will include blood tests, skin biopsies, and     bone marrow biopsies.   "
168801|NCT00047073|"     RATIONALE: Chemotherapy drugs such as sirolimus use different ways to stop tumor cells from     dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink     the tumor so that it can be removed during surgery.      PURPOSE: Phase I/II trial to study the effectiveness of sirolimus in treating patients who     have glioblastoma multiforme that did not respond to previous radiation therapy.   "
168802|NCT00047099|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and giving them after surgery may kill     any remaining tumor cells following surgery. It is not yet known which combination     chemotherapy regimen is more effective in treating breast cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination     chemotherapy regimens in treating women who have primary breast cancer.   "
168803|NCT00047112|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving combination chemotherapy with radiation therapy before     surgery may shrink the tumor so it can be removed during surgery. It is not yet known if     surgery is more effective with or without radiation therapy and chemotherapy in treating     esophageal cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without     radiation therapy and chemotherapy in treating patients who have esophageal cancer.   "
168804|NCT00047125|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation     therapy in different ways may kill more tumor cells. It is not yet known which regimen of     radiation therapy is more effective in treating patients who have metastases to the lymph     nodes in the neck.      PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in     treating patients who have metastases to the lymph nodes in the neck from an unknown primary     tumor.   "
168805|NCT00047138|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor     so it can be removed during surgery. Giving more chemotherapy after surgery may kill any     remaining tumor cells. It is not yet known which chemotherapy regimen after surgery is most     effective in treating Wilm's tumor.      PURPOSE: Phase III trial to study the effectiveness of chemotherapy before and after surgery     in treating children who have Wilm's tumor.   "
168806|NCT00047164|"     RATIONALE: Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can     locate cancer cells and either kill them or deliver cancer-killing substances to them without     harming normal cells.      PURPOSE: This phase II trial is studying anti-cytotoxic T-lymphocyte-associated antigen-4     monoclonal antibody to see how well it works in treating patients with lymphoma or colon     cancer that has not responded to vaccine therapy.   "
168807|NCT00047177|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating children who     have recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal or     atypical teratoid rhabdoid tumor.   "
168808|NCT00047190|"     Phase II trial to study the effectiveness of tipifarnib in treating patients who have     myelofibrosis with myeloid metaplasia. Tipifarnib may stop the growth of tumor cells by     blocking the enzymes necessary for tumor cell growth.   "
168809|NCT00047203|"     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Phase II trial to study the effectiveness of flavopiridol in treating     patients who have relapsed or refractory multiple myeloma   "
168810|NCT00047216|"     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary     for tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who     have recurrent bladder cancer.   "
168811|NCT00047229|"     RATIONALE: Drugs used in chemotherapy such as doxorubicin use different ways to stop tumor     cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of     doxorubicin by making tumor cells more sensitive to the drug.      PURPOSE: Phase II trial to study the effectiveness of combining oblimersen with doxorubicin     in treating patients who have locally advanced, recurrent, or metastatic hepatocellular     carcinoma (liver cancer).   "
168812|NCT00047242|"     RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor     cells.      PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with irinotecan in     treating patients who have advanced solid tumors.   "
168813|NCT00047255|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. It is not yet known if docetaxel and trastuzumab are more effective with or without     carboplatin in treating women who have HER2-positive breast cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of combining docetaxel and     trastuzumab with or without carboplatin in treating women who have HER2-positive stage IIIB     or stage IV breast cancer.   "
168814|NCT00047268|"     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the patient's     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. It is not yet known whether donor stem cell     transplant is more effective with or without chemotherapy in treating primary myelodysplastic     syndrome.      PURPOSE: This phase III trial is studying how well donor stem cell transplant given with     chemotherapy works and compares it with donor stem cell transplant without chemotherapy in     treating children with primary myelodysplastic syndrome.   "
168815|NCT00047281|"     RATIONALE: Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood     flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. Combining thalidomide and celecoxib with etoposide and     cyclophosphamide may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and celecoxib     with etoposide and cyclophosphamide in treating patients who have relapsed or refractory     malignant glioma.   "
168816|NCT00047294|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Thalidomide and celecoxib may stop the growth of tumor cells by     stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making     tumor cells more sensitive to the drug.      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide, thalidomide,     and celecoxib following radiation therapy in treating patients who have newly diagnosed     glioblastoma multiforme.   "
168817|NCT00047307|"     Drugs used in chemotherapy work different ways to stop tumor cells from dividing so they stop     growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Flavopiridol     may make the tumor cells more sensitive to radiation therapy. Phase I trial to study the     effectiveness of combining flavopiridol with radiation therapy followed by gemcitabine     hydrochloride in treating patients who have locally advanced, unresectable pancreatic cancer.   "
168818|NCT00047320|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink     the tumor so that it is no longer present by conventional imaging and tumor markers from     serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor     cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of     chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill     more tumor cells.      PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without     surgery and with or without high dose chemotherapy and peripheral stem cell transplantation,     can increase response rates prior to radiation therapy and increase progression free and     overall surviving patients with newly diagnosed intracranial germ cell tumors.   "
168819|NCT00047333|"     Phase II trial to study the effectiveness of erlotinib in treating patients who have liver     cancer that cannot be surgically removed. Erlotinib may stop the growth of tumor cells by     blocking the enzymes necessary for their growth   "
168820|NCT00047346|"     Phase I trial to study the effectiveness of erlotinib in treating patients who have     unresectable liver cancer and liver dysfunction. Biological therapies such as erlotinib may     interfere with the growth of tumor cells and slow the growth of the tumor   "
168821|NCT00047385|"     RATIONALE: Effective screening tests should help doctors detect lung cancer early and plan     curative treatment. It is not yet known whether low-dose helical computed tomography (LDCT)     screening is more effective than chest radiography (CXR) screening in reducing death from     lung cancer.      PURPOSE: Randomized clinical trial to compare the effectiveness of LDCT scan with that of CXR     in screening individuals who are at high risk for developing lung cancer.   "
168827|NCT00047476|"     To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of     chemotherapy-related fatigue in adult cancer subjects.   "
168828|NCT00047489|"     ABT-751 is a new antitumor drug that that interferes with cell division. The goal of this     clinical research study is to find the highest safe dose of ABT-751 that can be given as a     treatment for refractory hematologic malignancies. The safety and side effects of ABT-751     will also be studied.   "
168829|NCT00047502|"     The purpose of this study if to investigate the effect of lonafarnib (SCH66336) in     combination with Gleevec in the treatment of CML.   "
168830|NCT00047515|"     To compare intraocular pressure lowering effectiveness of a combination drug vs. two     individual drugs dosed alone.   "
168831|NCT00047528|"     To compare intraocular pressure lowering effectiveness of a combination drug vs. two     individual drugs dosed alone.   "
168832|NCT00047541|"     To compare intraocular pressure lowering effectiveness of a combination drug vs. two     individual drugs dosed alone.   "
168833|NCT00047554|"     The purpose of this study was to monitor iris pigmentation changes over a 5-year period in     patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these     individuals must have experienced an iris pigmentation change while previously dosing with     TRAVATAN.   "
168834|NCT00047567|"     To study the safety and efficacy of zonisamide as adjunctive therapy for children and     adolescents with bipolar I or II disorder.   "
168835|NCT00047580|"     This study is being conducted to compare the impact of somnolence (sleepiness) on cognition     (awareness) as well as the safety and effectiveness of tizanidine hydrochloride capsules     versus Zanaflex® (tizanidine hydrochloride tablets) taken while in the fed state (just after     a meal) and in the fasted state (before a meal) in patients with moderate to severe     spasticity.   "
168836|NCT00047593|"     The purpose of this study is to evaluate safety and efficacy of two different IOP lowering     medications after twelve months of treatment in Japanese subjects.   "
168837|NCT00047606|"     The purpose of this study is to evaluate safety and efficacy of two different IOP lowering     medications after six weeks of treatment in Caucasian and Japanese subjects.   "
168838|NCT00047619|"     The purpose of this study is to investigate the use of pulsatile lavage to enhance the     healing of pressure ulcers in individuals with spinal cord injury (SCI).      The goals will be achieved using a repeated-measures double-blinded randomized controlled     study of individuals with SCI who have pelvic region pressure ulcers. A total of 60 subjects     will be recruited to this study. Participants will be randomly assigned to a treatment or     control group. Pulsatile lavage treatment will be administered to the treatment group daily     for a 3 week period. The control group subjects will receive daily sham pulsatile lavage     treatment for 3 weeks. All subjects will be monitored for a 3 week period and will continue     to receive routine pressure ulcer care, i.e. dressings and bedrest with a regular turning     regime during their participation in the study.      All study participants will be monitored following the study period until complete closure of     the pressure ulcer is achieved in order to determine total interval to final closure,     including any surgical procedures required. In addition, the economic effects of pulsatile     lavage treatment will be evaluated through monitoring of data collected in the Computerized     Patient Record System (CPRS), including duration of admission, duration of total bedrest     order and duration of treatment for pressure ulcer. This data will give an initial measure of     the cost benefits that may be achieved with the use of pulsatile lavage for the treatment of     pressure ulcers.      Subjects will be recruited from the Louis Stokes Cleveland Veterans Affairs Medical Center     (CVAMC). All individuals with spinal cord injury who are admitted to the SCI Unit with pelvic     region pressure ulcers will be considered eligible for this study. Further selection criteria     will be employed to screen potential participants as described below. On recruitment subjects     will be randomly assigned to 2 groups of 20 subjects. The assessment methods employed will be     the same for each volunteer. One group will participate in the pulsatile lavage intervention,     the second group will act as controls.   "
168839|NCT00047632|"     The purposes of this study are to determine: 1) if treatment with interferon gamma-1b plus     standard chemotherapy (carboplatin and paclitaxel) can increase the overall survival of     patients with advanced ovarian or primary peritoneal carcinoma compared with chemotherapy     alone; 2) how effective interferon gamma-1b plus standard chemotherapy is in preventing the     progression or return of cancer; 3) the effects on quality of life; and 4) the safety of     interferon gamma-1b combined with standard chemotherapy compared to chemotherapy alone.   "
168840|NCT00047645|"     Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b     administered by subcutaneous injection; compared to placebo in patients with IPF who are     unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g     1b group or a placebo group.   "
168841|NCT00047658|"     Study GIPF-002 is a phase 2 study designed to characterize the biologic and clinical effects     of IFN-g 1b. The objective of the Study is to characterize the biologic and clinical effects     of IFN-g 1b administered to patients with idiopathic pulmonary fibrosis (IPF). The Study will     be conducted at multiple sites and enroll 30 patients with IPF who have failed treatment with     corticosteroids.   "
168842|NCT00047671|"     This 11-week study aims to determine how genetic factors affect the way African Americans and     Caucasians with major depression respond to antidepressant medication [citalopram (Celexa®)].   "
168843|NCT00047684|"     The purpose of this study is to refine Brief Integrative Therapy (BIT) and to evaluate its     effectiveness in treating women with Post-Traumatic Stress Disorder (PTSD) following     childhood sexual abuse. This study will also promote the development of skills that are     necessary for increasing quality of life and improving self-esteem.   "
168844|NCT00047697|"     This 11-week study will examine the safety and effectiveness of the medication donepezil     (Aricept®) compared to placebo for treating cognitive deficits in children and adolescents     with Autism Spectrum Disorder.   "
168845|NCT00047710|"     The goal of this clinical research study is to find the highest safe dose of the drug     Bevacizumab that can be given in combination with chemoradiation for the treatment of     pancreatic cancer. The effect that this combination treatment has on the tumor will also be     studied.   "
168846|NCT00047723|"     The purpose of this trial is to test the safety, tolerability, and effectiveness of     minocycline compared to placebo in patients with amyotrophic lateral sclerosis (ALS).   "
168847|NCT00047736|"     The purpose of this study is to determine if Tarceva plus standard chemotherapy is more     effective than standard chemotherapy alone in the treatment of lung cancer.   "
168848|NCT00047749|"     The purpose of this study is to understand the effects of intrathecal ziconotide (an     experimental pain medication) when the dose is slowly increased over a 3-week period in     patients with severe chronic pain. During the weaning phase, the study will also gather     information about switching from other intrathecal or IT medication (slowly pumped directly     into the space around the spine) to other systemic pain medication (by mouth or through the     skin using a patch). After being weaned off current IT medication, patients will be placed on     IT ziconotide or placebo (non-active substance) as well as being allowed a stable dose of     systemic pain medications.      Patients who complete this study may be eligible for long-term ziconotide therapy via     extension protocol ELN92045-352.   "
168849|NCT00047762|"     The purpose of this study is test the safety of Tarceva, find the best dose, and see what     effects (good and bad) it has on you and your colorectal cancer. The effects of Tarceva will     be evaluated in combination with 5-fluorouracil, leucovorin, and irinotecan, with or without     Bevacizumab.   "
168850|NCT00047775|"     A placebo-controlled trial of BiDil added to standard therapy in African-American patients     with heart failure.   "
168851|NCT00047788|"     The primary objective is to assess the efficacy of ZD6474 when given orally to patients with     relapsed multiple myeloma. A minimum of 15 and a maximum of 30 evaluable patients will be     entered on study   "
168852|NCT00047801|"     The purpose of this study is to determine the effectiveness and safety of TLK286 given     intravenously once every three weeks in combination with docetaxel (Taxotere) in the     treatment of patients with non-small cell lung cancer that is resistant to platinum-based     chemotherapy.   "
168853|NCT00047814|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of 4     weeks therapy with FK788 in subjects with chronic hepatitis C virus (HCV) infection. Also, to     assess the effect of FK788 on serum ALT concentration and hepatitis C viral level during     therapy and for four weeks following therapy.   "
168854|NCT00047827|"     The purpose of this study is to evaluate the safety and effectiveness of micafungin in     combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.   "
168855|NCT00047840|"     The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with     NSCLC after Failure of Prior Platinum-based Chemotherapy.   "
168856|NCT00047853|"     The purpose of this study is to use brain imaging technology to investigate brain changes in     people exposed to predictable versus unpredictable unpleasant stimuli. Unpleasant events that     can be predicted evoke a response of fear, whereas unpredictable, unpleasant stimuli cause     chronic anxiety not associated with a specific event. Information gained from this study may     help in the development of more effective treatments for anxiety disorders.      When confronted with fearful events, people eventually develop fear of specific cues that     were associated with these events as well as to the environmental context in which the     fearful event occurred. Evidence suggests that cued fear and contextual fear model different     aspects of anxiety. However, studies that examine the way the brain affects expression of     contextual fear have not been conducted. This study will use magnetic resonance imaging (MRI)     or Magneto-encephalography (MEG) to compare the brain activity underlying fear brought on by     predictable and unpredictable aversive stimuli.   "
168872|NCT00048087|"     Patients will receive 250 mg Iressa by mouth daily each day while on this study. Patients     will also receive docetaxel 30 mg/m2 by by vein (IV) on day 1 weekly for the first 3 weeks of     each course of therapy. A course of therapy is 4 weeks. Patients will not receive docetaxel     during week 4. A maximum of 8 full cycles of docetaxel plus Iressa are planned. Patients may     continue on daily Iressa until progressive disease and/or unacceptable toxicity.   "
179533|NCT00186420|"     The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with     high risk prostate cancer after definitive therapy.   "
168857|NCT00047866|"     This study seeks more information about the biology of substance dependency by exploring the     brain areas involved in feeling positive and negative emotions. Specifically, it will     determine whether a brain chemical called dopamine affects activity in certain brain regions     during performance of a game that involves winning and losing money. Brain activity will be     examined using magnetic resonance imaging (MRI), a test that uses a magnetic field and radio     waves to produce images of brain structure and function.      Young to middle-aged healthy adults may participate in this study. Candidates will be     screened with a medical history, physical examination, electrocardiogram (EKG), psychiatric     interview, and blood and urine tests. Participants will be assigned to one of the two study     procedures, as follows:      Tyrosine/Phenylalanine      This study requires two overnight stays at the NIH Clinical Center. For each stay, subjects     are admitted to the hospital the afternoon before the MRI scan. From the time of admission     until after the scan, their diets are restricted to food relatively low in amino acids,     prepared by NIH dietitians. The next day, participants undergo MRI scanning. For this     procedure, the subject lies on a table that is moved into the scanner, a metal cylindrical     machine. Earplugs are worn to muffle loud noises that occur with electrical switching of the     radio frequency circuits. Imaging of brain structure takes about 10 to 15 minutes. Additional     scans are then taken to measure brain activity while the subject plays simple computer games     for money. These scans take about another 20 to 45 minutes. Five hours before the MRI, the     subject drinks one of two beverages containing amino acids. A different beverage is given for     each of the two visits: one drink lacks the essential amino acids tyrosine and phenylalanine,     from which the body makes dopamine; the other contains balanced amounts of these two amino     acids. Finally, subjects fill out mood-rating questionnaires before and after drinking each     of the beverages.      Dextroamphetamine      This study requires two outpatient visits to the NIH Clinical Center. For one visit,     participants are given an injection of 0.2 mg/kg body weight of the drug dextroamphetamine;     for the other, they are given an injection of saline (salt water). After each injection, they     undergo MRI scanning while playing computer games for money, as described above. They will     fill out mood-rating questionnaires before and after each brain scan.   "
168858|NCT00047879|"     This study will examine the safety and effectiveness of peginterferon alpha-2b (PEG-Intron)     alone and together with thalidomide in patients with gliomas (a type of brain tumor). Gliomas     are nourished by blood delivered through blood vessels whose formation is stimulated by     substances produced by the tumor itself. Stopping the growth of new vessels can slow or     prevent tumor growth. The Food and Drug Administration has approved various interferons for     treating several diseases, including melanoma and some leukemias. These drugs block new     vessel growth in patients with recurrent tumors, but in high doses they produce serious side     effects. Therefore, this study will use a low dose of PEG-Intron given weekly instead of high     doses given several times a week. Thalidomide, currently approved to treat leprosy, also     blocks development of new blood vessel formation. In a recent study of thalidomide given to     36 patients with gliomas, 4 patients had tumor shrinkage, 12 had stable disease for at least     2 months, and at least 3 had responses to treatment lasting 6 to 14 months.      Patients 18 years of age and older with a primary glioma whose tumor has recurred or is     growing following standard treatment and does not respond to radiation therapy may be     eligible for this study. Candidates will be screened with a physical examination, blood and     urine tests (including a pregnancy test for women of childbearing potential), and magnetic     resonance imaging (MRI) or computed tomography (CT) of the head.      Patients will continue treatment cycles as long as the drug is tolerated without serious side     effects and the tumor is not growing. While on the study, patients will undergo various tests     and procedures as follows:      Physical and neurologic examinations every 6 weeks MRI or CT brain scan every 6 weeks to     assess tumor status. MRI is a diagnostic test that uses a strong magnetic field and radio     waves to show structural and chemical changes in tissues. During the scan, the patient lies     on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff     member through an intercom system at all times during the procedure.   "
168859|NCT00047905|"     This study will examine the process of prenatal genetic counseling to determine how various     client and counselor factors affect the communication process in a counseling session. The     specific aims of the study are to:        -  Provide information on prenatal genetic counselors' interactions with clients for the          basis of a future larger study of the genetic counseling process.        -  Determine the average length and the range of length of prenatal genetic counselors'          interactions with clients when family history information has already been provided.        -  Document on videotape the communication content and interaction dynamics of prenatal          genetic counselors interacting with clients in order to:        -  Characterize different models of prenatal genetic counseling        -  Determine the nature of discussions concerning cystic fibrosis carrier testing within          the context of prenatal genetic counseling.        -  Examine the impact of prenatal genetic counselors' characteristics (years of experience,          training and background, age, clinical setting, anxiety) on the communication content          and interaction dynamics of sessions with clients.        -  Examine the impact of the presence of a spouse on the communication content and          interaction dynamics of prenatal genetic counseling sessions with clients.        -  Examine the impact of client verbal emotional cues on the communication content and          interaction dynamics of prenatal genetic counseling sessions.      Counselors will be recruited for this study from among practicing prenatal genetic counselors     at regional meetings and a national meeting of the National Society of Genetic Counselors.     They will perform prenatal genetic counseling sessions with actors in the roles of client and     client's spouse. The sessions will be videotaped, and the counselor and actors will fill out     questionnaires regarding the characteristics of the counselor and the session.      Counselors may be contacted later to request permission to use segments of their videotaped     sessions for creating a video teaching tool for counseling professionals that illustrates     different ways to practice the genetic counseling.   "
168867|NCT00048022|"     The primary objective of the study is to evaluate the anti-inflammatory action and safety of     Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The     research is being conducted at up to 40 clinical research sites in the US. Study participants     will have a number of visits to a research site over a 4-month period.   "
168860|NCT00047918|"     This study will 1) identify characteristics of bone marrow mast cells in patients with     unexplained anaphylaxis and flushing or with mastocytosis and 2) determine whether     mastocytosis might be the underlying cause of unexplained anaphylaxis in some patients with     this condition. Anaphylaxis is a hypersensitivity reaction in which patients may have     flushing, hives, stuffy nose, red itchy eyes, difficulty breathing, swelling of the tongue,     throat, palms and soles, abdominal cramping, lightheadedness, decreased blood pressure, and     loss of consciousness. Although allergens are a common cause of anaphylactic episodes, no     cause can be identified in up to 50 percent of patients who have recurrent events.     Mastocytosis is a disease of excessive mast cells in tissues such as skin and bone marrow.     These cells can release chemicals that result in itching, blisters, flushing, bone pain, and     abdominal pain.      Patients 18 years of age and older who have episodes of anaphylaxis or flushing with no     apparent cause or who have mastocytosis may be eligible for this study. Participants will     have a medical history and physical examination; blood tests to identify genetic changes that     are important in the growth, development, and functioning of human mast cells; and bone     marrow aspiration and biopsy. For the bone marrow procedure, the skin over the hipbone and     the outer surface of the bone itself are numbed with local anesthesia. Then, a special needle     is inserted into the hipbone and about 1 tablespoon of bone marrow is drawn into a syringe.     Another needle is inserted into the same area to collect a small piece of the bone marrow.     Additional procedures may include allergen testing, urinalysis, and 24-hour urine collection.      Participants will return to NIH for reassessment of disease status in 12 to 18 months. The     follow-up evaluation will include a history and physical examination, blood tests, possible     repeat bone marrow and aspiration in patients whose clinical signs or symptoms change     significantly, and other tests as clinically indicated.      First-degree relatives (parents, children, siblings) may be enrolled in limited instances to     provide a blood sample for genetic analysis related to mast cell development and function for     comparison with that of patients when they have similar symptoms.   "
168873|NCT00048100|"     Objectives:        1. Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute          leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell          transplants.        2. Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in          patients after infusion.        3. Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in          Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting          and sustaining remission in patients with relapse after allo-BMT or stem cell          transplant.   "
168874|NCT00048113|"     ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific     protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant     role in the increase of inflammation. People with Crohn's disease have been shown to     over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA,     the instruction molecule that is required for the production of ICAM-1 protein. This trial     will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week     period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or     immunosuppressive drugs, and prednisone (or equivalent) at </= 30 mg per day.   "
168861|NCT00047931|"     This study will test the safety of an experimental vaccine against HIV and examine whether it     induces an immune response to HIV. A vaccine is a substance given to try to create resistance     or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic     material) of four HIV proteins called 'gag', 'pol', 'Nef', and 'Env'. Injected into a human,     the viral DNA instructs the body to make small amounts of some HIV proteins. This study will     see if the body then creates an immune response to these proteins. Study participants cannot     catch HIV or AIDS from the DNA vaccine or any proteins made from it.      Healthy normal volunteers between 18 and 40 years of age may be eligible for this study.     Candidates will be screened with a medical history, physical examination and blood and urine     tests. Women will also have a pregnancy test. Women enrolled in the study must either be     infertile (e.g., due to menopause or hysterectomy) or must agree either to abstain from     heterosexual sex or to practice birth control for at least 21 days before beginning the study     and throughout its duration.      Participants will be randomly assigned to receive either the experimental vaccine or a     placebo (a salt solution that does not contain any active substance) and will be divided into     three groups, based on their entry into the study. Of the first seven people enrolled (Group     1), five will receive a 2-mg dose of vaccine and two will receive placebo. If the vaccine is     safe at this dose, then in Group 2, five people will receive a 4-mg dose of vaccine and two     will receive placebo. If this dose is safe, then in Group 3, thirty people will receive an     8-mg dose of vaccine and six will receive placebo.      All participants will receive three injections in an upper arm muscle-one injection a month     for three months-with a needle-less device called a Biojector 2000® (Registered Trademark).     At the time of each injection, participants will be observed for at least 1 hour after     immunization. At home, they will record their temperature and any symptoms they may     experience, including any effects at the injection site, for at least 7 days, or as long as     the symptoms remain. If symptoms occur, participants will report them immediately to the     clinic staff and, if necessary, come to the clinic for an examination.      Participants will have about 10 clinic visits during the study. Most visits will last about 2     hours; those on vaccination days will last about 4 hours. ...   "
168862|NCT00047944|"     Anxiety in children of parents with major depressive disorder (MDD) poses a particularly high     risk for later-life MDD. In adults, MDD involves dysfunction in prefrontal brain regions that     regulate attention to emotional stimuli. These abnormalities: i) have been found primarily in     adults with specific familial forms of MDD; ii) persist after recovery from MDD, and iii)     relate to anxiety. These findings raise the possibility that risk for MDD is tied to     dysfunction in prefrontal regions involved in regulation of emotion, which possibly manifests     as early-life anxiety. If this possibility were confirmed in never-depressed adolescents at     high risk for MDD, the findings would provide key insights into the developmental     neurobiology of MDD. The goal of this protocol is to study the neural substrate of risk for     MDD in young people. This protocol tests the hypothesis that adolescents at high risk for MDD     by virtue of childhood anxiety and parental history of MDD exhibit dysfunction in prefrontal     cortex and amygdala, regions involved in emotion regulation. This goal will be accomplished     through fMRI studies of emotion regulation in high and low-risk adolescents.      For this research, at-risk adolescents will be recruited from participants in an NIMH-funded     extramural study at New York University (NYU) examining the biology of risk for anxiety and     depressive disorders. Over a three-year period, 45 high-risk probands and 60 low-risk     comparisons will be studied, including 20 comparisons from the NYU sample and 40 from the     Washington DC metropolitan area. In the present protocol, to be conducted at NIH, subjects     will undergo volumetric MRI scans to assess structural abnormalities in the prefrontal cortex     and medial temporal lobe. They will complete a series of four out-of-scanner cognitive tasks     and two fMRI-based cognitive tasks that measure modulation of attention to emotional stimuli.     The fMRI tasks are hypothesized to differentially engage the prefrontal cortex and amygdala     in low vs. high risk subjects. These tasks will be used to test the hypothesis that at-risk     individuals exhibit enhanced amygdala and reduced prefrontal activation on the fMRI     emotion/attention tasks.   "
168863|NCT00047957|"     This study will use transcranial magnetic stimulation, or TMS (described below), to examine     how the brain controls muscle movement to prevent unwanted movements in surrounding muscles.     For example, when a person moves a finger, a part of the brain called the cortex prevents     unwanted movements in other fingers by a process called cortical inhibition. In people with     the muscle disorder dystonia, cortical inhibition does not work properly and patients suffer     from uncontrolled and sometimes painful movements. A better understanding of how this process     works in normal people may shed light on what goes wrong in dystonia and how the condition     can be treated.      Healthy normal volunteers 19 years of age and older may be eligible for this study.     Candidates will be screened with a medical history and physical and neurological     examinations. People with a current medical or surgical condition or neurological or     psychiatric illness may not participate, nor may individuals who are taking medication that     may influence nervous system function.      Participants will undergo TMS to record the electrical activity of muscles in the hand and     arm that are activated by magnetic stimulation. For the procedure, subjects are seated in a     chair with their hands placed on a pillow in their laps. A wire coil in placed on their     scalps. A brief electrical current is passed through the coil, creating a magnetic pulse that     stimulates the brain. Subjects will be asked to move their second finger in response to a     loud beep or visual cue. In some trials, a brief, mild electrical shock will also be applied     to the end of either the second or fifth finger. The shock is not painful.      TMS may cause muscle, hand or arm twitching if the coil is near the part of the brain that     controls movement, or it may induce twitches or temporary tingling in the forearm, head, or     face muscles. The twitching may cause mild discomfort, but the procedure is rarely considered     painful.   "
168864|NCT00047970|"     The Sister Study is prospectively examining environmental and familial risk factors for     breast cancer and other diseases in a cohort of 50,884 sisters of women who have had breast     cancer. Such sisters have about twice the risk of developing breast cancer as other women.   "
168865|NCT00047983|"     The purpose of this study is to evaluate the effectiveness of nutritional supplements in     increasing the amount of omega-3 fatty acids (and arginine) in the red blood cell membranes     and plasma of kidney transplant patients, and, secondarily, to compare patient compliance.     The long-term goal of this study is to develop low risk therapies that will allow improved     and lasting survival of donor tissue with minimal suppression of the immune system.   "
168866|NCT00048009|"     The purpose of this study is to determine the appropriate dose of Ro 27-2441 (test drug) to     be used in future studies, assess the efficacy and safety, and the anti-inflammatory action     of the test drug in the treatment of asthmatic patients who are not currently receiving     chronic therapy with corticosteroids. The research is being conducted at up to 80 clinical     research sites in the US, Mexico, and Canada. Study participants will have a number of visits     to a research site over approximately a 4-month period.   "
168911|NCT00048646|"     The purpose of this study is to determine if progesterone treatment safely reduces brain     swelling and damage after injury.   "
168868|NCT00048035|"     This study will determine the appropriate dose and frequency of administration of iv Mircera     maintenance therapy in hemodialysis patients with chronic renal anemia who were previously     receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target     sample size is <100 individuals.   "
168869|NCT00048048|"     This study will evaluate the efficacy and safety of different subcutaneous starting doses and     dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on     dialysis. The anticipated time on study treatment is 3-12 months and the target sample size     is <100 individuals.   "
168870|NCT00048061|"     This study will compare the efficacy and safety of different treatment regimens of oral     Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily     supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+     years, and the target sample size is 500+ individuals.   "
168871|NCT00048074|"     This study will assess the efficacy and safety of intravenous administration of Bonviva     regimens in women with post-menopausal osteoporosis, compared to oral daily administration.     Patients will also receive daily supplementation with vitamin D and calcium. The anticipated     time of study treatment is 2+ years, and the target sample size is 500+ individuals.   "
179546|NCT00186589|"     To test a new way to approach hematopoietic stem cell transplantation for Relapsed or     Resistant Non-Hodgkin's Lymphoma.   "
168875|NCT00048126|"     This study will assess the efficacy and safety of continuous oral Xeloda administration in     combination with intravenous irinotecan as a first-line treatment in patients with advanced     and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months     and the target sample size is <100 individuals.   "
168876|NCT00048139|"     This study will assess the efficacy and safety of intermittent oral Xeloda administration in     combination with irinotecan as a first-line treatment in patients with advanced and/or     metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the     target sample size is <100 individuals.   "
168877|NCT00048152|"     This study will compare kidney function in kidney transplant patients following treatment     with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine).     The anticipated time on study treatment is 6-12 months, and the target sample size is 500+     individuals.   "
168878|NCT00048165|"     The purpose of the study is to compare the number of randomized participants in each     treatment group who experience an acute rejection episode in the first 6 months after     undergoing cardiac transplantation.   "
168879|NCT00048204|"     A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With     Major Depressive Disorder (MDD)   "
168880|NCT00048217|"     Patients who complete study T1249-102 (must be currently failing a T-20 containing regimen to     participate in this study) will receive T-1249 at a dose of 200mg daily in combination with a     background antiretroviral regimen for 96 weeks. Only patients that participated in study     T1249-102 can participate in study T1249-105.   "
168881|NCT00048230|"     This study will compare the efficacy of PS-341 versus high dose dexamethasone.   "
168882|NCT00048256|"     This study will look at how people cope with an upcoming bone marrow transplant and how     personality characteristics influence coping styles in stressful medical situations.     Personality traits, such as extraversion, optimism and self-esteem have been related to     active, problem-focused coping styles, whereas neuroticism has been related to increased     psychological distress and denial as a way of coping. Coping styles, in turn, have been     related to disease outcome. For example, a fighting spirit and avoidance have been correlated     with longer survival, whereas fatalism, anxious preoccupation and feelings of helplessness     and hopelessness were related to a poor disease outcome. A better understanding of the     relationship between coping styles and personality may help improve supportive care for     people undergoing bone marrow transplants. This study will:        -  Explore the relationship between personality traits, coping styles and psychological          stress in patients awaiting bone marrow transplantation        -  Identify what coping styles people use to prepare for bone marrow transplantation        -  Identify what personality traits are related to particular coping styles in patients          awaiting bone marrow transplantation        -  Identify the relationship between personality factors and level of psychological          distress in patients awaiting bone marrow transplantation      Cancer patients 18 years of age and older who are scheduled for bone marrow transplant are     eligible for this study.      Participants will fill out pencil-and-paper questionnaires providing demographic information     (such as age, gender, marital status, ethnicity, and so forth) and answering questions about     their opinions and preferences. The information will be used to assess the participants'     personality characteristics, coping styles, and psychological distress. The questionnaires     take about 45 to 50 minutes to complete.   "
168883|NCT00048282|"     The purpose of this study is to provide researchers with information that will help them     prepare for a future study to test the efficacy of two anti-HIV vaginal gels. This study will     also estimate how likely people living in certain areas are to become infected with HIV and     other infections passed during sex.   "
168912|NCT00048659|"     The purpose of this study is to determine if patients who take YM598 in addition to     mitoxantrone and prednisone (standard therapy) experience improvement in the pain associated     with prostate cancer metastases in the bone.   "
169089|NCT00051298|"     This study is to determine the efficacy (how well the drug works), safety, and any side     effects of olanzapine compared to placebo in the treatment of schizophrenia in adolescents.     Both the potential benefits and side effects of olanzapine will be evaluated throughout this     trial.   "
168884|NCT00048295|"     ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific     protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant     role in the increase of inflammation. People with Crohn’s disease have been shown to     over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA,     the “instruction” molecule that is required for the production of ICAM-1 protein. This trial     will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week     period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or     immunosuppressive drugs, and prednisone (or equivalent) at </= 30 mg per day.   "
168885|NCT00048308|"     During a heart bypass procedure, a substance called complement is released by the body.     This complement causes inflammation, which can lead to side effects such as chest pain, heart     attacks, heart failure, or impairment of memory, language and motor skills. The purpose of     this study is to find out if the study drug (pexelizumab), which blocks complement release,     can reduce such side effects and be taken safely.   "
168886|NCT00048321|"     ISIS 104838 is an antisense oligonucleotide drug that reduces the production of a specific     protein called tumor necrosis factor (TNF-alpha), a substance that contributes to joint pain     and swelling in rheumatoid arthritis. ISIS 104838 works by blocking TNF-alpha messenger RNA,     the instruction molecule that is required for the production of TNF-alpha protein. This     trial will assess the safety and efficacy of ISIS 1048383 by subcutaneous injection,     administered by 3 different dosing regimens for 3 months, versus placebo. Approximately 160     TNF-alpha inhibitor-naïve rheumatoid arthritis patients will be evaluated at 32 sites in the     U.S. and Canada.   "
168887|NCT00048334|"     This phase I study will evaluate the experimental drug Romidepsinin patients with advanced     cancer. The study will: 1) determine how well patients tolerate Romidepsin; 2) measure blood     levels of Romidepsin during treatment; 3) analyze the cellular and molecular effects of the     drug; and 4) determine if Romidepsin can shrink tumors. Romidepsin has been shown to kill     cancer cells growing in the laboratory and to shrink tumors in animals with various tumor     types. In preliminary studies, several patients with a type of lymphoma and one patient with     kidney cancer responded to treatment.      Patients 18 years of age and older with advanced cancer (excluding acute leukemia) may be     eligible for this study. Candidates are screened with a medical history and physical     examination, x-rays and CT scans, and blood and urine tests. Patients with thyroid cancer may     also have magnetic resonance imaging (MRI). This test uses a magnetic field instead of x-rays     to obtain images or body organs and tissues.      Participants receive three infusions of Romidepsin administered through an intravenous line     over 4 hours on days 1, 3 and 5 of a 21-day treatment cycle. The intravenous line is a     catheter (plastic tube) placed in a vein and may be a peripheral line, inserted in a vein in     the arm, or a central line, in which the tube is placed under the skin of the chest or neck     into a major vein. Patients are hospitalized for the first 6 days of the first cycle to     monitor heart rate. Those who tolerate the treatment well may continue as an outpatient.      In addition to drug therapy, participants undergo the following procedures:        -  Blood tests: Small amounts of blood are drawn frequently during the first five days of          treatment to measure Romidepsin levels and to see how the body uses and excretes the          drug. A heparin lock (an indwelling device to keep the vein open) may be put in the vein          to prevent the need for repeated needle sticks.        -  Biopsies (removal of a small sample of tumor tissue): Tumors that are accessible may be          biopsied at the start of the study and at different times during treatment. Biopsies are          done no more than three times per cycle, and no more than nine biopsies are done within          a year. The samples are examined for the effects of Romidepsin on proteins that control          the way cells divide and stay alive.        -  Apheresis: This procedure is done to collect white blood cells and cancer cells for          research. Blood is collected through a needle in an arm vein and directed into a machine          that separates it into its components by centrifugation (spinning). The white cells are          removed and the red cells are returned to the patient through the same needle or through          another needle in the other arm.        -  Scans and x-rays: Imaging studies are usually done before starting treatment. Some of          them are repeated at every 2 cycles (6 weeks), and some at the end of the patient's          participation in the study. The tests may include chest x-rays, plain x-rays of affected          bones, CT scans of the chest, abdomen, and pelvis, bone scans, and a MUGA scan (special          X-ray of the heart) or echocardiogram (ultrasound of the heart) to test heart function          before and during the study. MRI or positron emission tomography (PET) scans may also be          done to detect tumors. PET scans use a small amount of a radioactive substance injected          into a vein. The radioactivity is detected by a special camera during scanning to detect          cancer cells.        -  Other tests include an electrocardiogram (recording of the electrical activity of the          heart) before and after each dose of depsipeptide. Eye exams are done if there are          vision changes or if the doctor recommends an eye test.   "
168932|NCT00033956|"     The clinical use of IL-2 is currently limited by development of dose-dependent hypotension     (systolic blood pressure (SBP) < 90 mm Hg). The overall outcome is constant across sites with     20-50% of the patients requiring ICU management because of unresponsive hypotension and     hyporeactivity (loss of response to vasoconstrictors). Because of the dose-limiting side     effects, the duration of IL-2 dosing is frequently curtailed. Thus, hemodynamic toxicities     have limited the usefulness of IL-2 therapy. M40403 has prevented both the hypotension and     hyporeactivity associated with IL-2 treatment in preclinical studies. This trial will study     the safety and efficacy of M40403 in the prevention or reduction of hypotension in patients     receiving IL-2 therapy.   "
169036|NCT00041093|"     Phase II trial to study the effectiveness of docetaxel in treating patients who have     persistent or recurrent cervical cancer. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die.   "
169070|NCT00051038|"     The purpose of this clinical research study is to assess the safety and effectiveness of     entecavir, when being added to lamivudine, in the treatment of adults with chronic hepatitis     B infection who are co-infected with HIV.   "
168888|NCT00048347|"     This study will evaluate the safety and effectiveness of the drug interferon-beta1a (AVONEX)     in treating ulcerative colitis and examine the drug's effect on the immune system. People     with ulcerative colitis have increased amounts of inflammatory chemicals (cytokines) made by     immune cells in the lining of the colon. Studies have shown that interferon-beta may block     the activity of these cytokines. Interferon-beta1a (AVONEX) is currently FDA-approved to     treat multiple sclerosis, a disease involving inflammation of the brain and spinal cord.      Patients 18 years of age and older who have had ulcerative colitis for at least 4 months may     be eligible for this study. Candidates will be screened with a review of their medical     records, a medical history and physical examination, electrocardiogram (EKG), blood, urine,     and stool tests, and a pregnancy test for women of childbearing potential. A colonoscopy will     also be done to determine disease activity and extent. This test uses a lighted tube to     examine the amount of inflammation in the colon and take tissue samples (biopsies) for     testing. Before the test, the patient is given a medicine to allay anxiety and the discomfort     of inserting the endoscope into the rectum. This flexible tube allows the doctor to see the     intestinal mucosa and project an image of the inner lining of the intestine onto a TV     monitor. At various places in the intestine, small pieces of tissue are plucked out by a     special device at the tip of the endoscope. The procedure generally lasts 30 minutes to 1     hour.      Participants will come to the NIH Clinical Center once a week for 4 weeks to receive an     injection of interferon-beta, fill out questionnaires, and have a symptoms check, physical     examination, and blood tests. Patients whose colitis has not worsened at the end of the 4     weeks and who have not had significant drug side effects will continue to receive weekly     injections for an additional 8 weeks. Some patients may receive some of the last eight     injections outside of NIH, but all patients will visit the Clinical Center visits every 3 to     4 weeks for a physical exam, symptoms check and blood tests.      After the 12 injections are completed, patients will have another colonoscopy to evaluate the     response to treatment and will return to the Clinical Center every 6 weeks for a total of     four visits, for a physical examination, symptoms check and blood tests.   "
168889|NCT00048360|"     This is a placebo controlled study evaluating the efficacy and safety of medication in adults     with Attention-Deficit Hyperactivity Disorder (ADHD).   "
168890|NCT00048373|"     The purpose of this study is to learn about the response of Langerhans cell histiocytosis     (LCH) to Enbrel in patients who have failed to respond to standard therapies. We are also     looking specifically at what side effects Enbrel has on patients. We expect to enroll 20     patients on this study and anticipate the subjects active participation to last up to one     year.   "
168891|NCT00048386|"     PRIMARY OBJECTIVE To determine the percentage of patients with high risk neuroblastoma in     first or subsequent partial response or better, or with microscopic residual bone marrow     disease, who demonstrate an immunological anti-tumor response at any time during, and for up     to 12 months from initiation of, treatment with subcutaneous injections of autologous     neuroblastoma cells, genetically modified by adenoviral vectors to secrete interleukin-2     (IL-2) (autologous neuroblastoma vaccine)      SECONDARY OBJECTIVES 1. To determine the toxicity of the autologous neuroblastoma vaccine     given according to this schedule 2. To obtain preliminary data on the effect of vaccine     administration on progression-free survival from high-risk neuroblastoma   "
168892|NCT00048399|"     To assess the safety, feasibility, and rate of donor engraftment for patients with primary or     secondary engraftment failure after treatment with fludarabine and CAMPATH 1H used as a     preparative regimen for HLA-identical sibling blood stem cell transplantation (SCT).      To assess the safety, feasibility, and rate of donor engraftment for patients with primary or     secondary engraftment failure after treatment with fludarabine and CAMPATH 1H as a     preparative regimen for matched unrelated or single antigen mismatched family donor marrow     transplantation.   "
168893|NCT00048412|"     1. To assess the treatment related mortality of allogeneic stem cell transplantation with          non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients          with hematological diseases and renal cell carcinoma not eligible for conventional          (myeloablative) therapy.        2. To assess the time to engraftment and incidence of graft failure in patients receiving          this transplant regimen.        3. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used          as part of a subablative conditioning regimen.   "
168894|NCT00048425|"     The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan     compared with placebo in the treatment of decompensated chronic heart failure.   "
168895|NCT00048438|"     The objective of this study is to determine whether paricalcitol is safe and effective     compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney     disease.   "
168896|NCT00048451|"     The objective of this study is to determine whether paricalcitol is safe and effective     compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney     disease.   "
168897|NCT00048464|"     Patients will have immune cells collected and then expanded outside of the body. Patients     will undergo standard treatment with high dose chemotherapy followed by peripheral blood stem     cell transplantation. Three days following the transplant, patients will receive an infusion     of a large number of expanded immune cells. The goal of the study will be to determine the     safety as well as potential efficacy of this treatment.   "
169090|NCT00051311|"     This study will investigate the safety and effectiveness of a modified stem cell transplant     procedure for treating cancers of the blood and immune system. Patients with cancers and     pre-cancerous conditions originating in blood or immune system cells can sometimes benefit     greatly from, and even be cured by, transplants of stem cells (cells produced by the bone     marrow that mature into blood cells). In addition to producing new bone marrow and restoring     normal blood production and immunity, the donated cells fight any residual tumor cells that     might have remained in the body, in what is called a graft-versus-tumor effect.      However, severe problems, and sometimes death, may follow these transplants as a result of     the high-dose chemotherapy and radiation that accompany the procedure. Also, donated immune     system cells called T cells sometimes attack healthy tissues in a reaction called     graft-versus-host-disease (GVHD), damaging organs such as the liver, intestines and skin.     This study will use the following strategies to try to reduce these risks:        -  induction chemotherapy to reduce patients immunity in an attempt to prevent rejection of          the donated stem cells;        -  reduced-intensity conditioning chemotherapy that is easier for the body to tolerate and          involves a shorter period of complete immune suppression;        -  donation of immune cells called Th2 cells instead of T cells to try to reduce the risk          of serious GVHD;        -  treatment with methotrexate and cyclosporine to try to reduce the risk of serious GVHD.      Patients between 12 and 75 years of age with non-Hodgkin s lymphoma, Hodgkin s lymphoma,     multiple myeloma, chronic lymphocytic leukemia, chronic myelogenous leukemia, acute     myelogenous leukemia, acute lymphocytic leukemia, myelodysplasia, idiopathic myelofibrosis,     polycythemia vera, or chronic myelomonocytic leukemia may be eligible for this study.     Candidates will have a medical history, physical and dental examinations, blood and urine     tests (including a blood test for genetic match with the donor), lung and heart function     tests, and X-ray studies. A bone marrow biopsy may be done to evaluate disease status.     Patients with lymphoma may have a nuclear medicine test called a positron emission tomography     (PET) scan.      Participants will have a central venous line (large plastic tube) placed into a major vein.     This tube can stay in the body and be used during the entire treatment period to deliver the     donated stem cells and give medications, including chemotherapy and other drugs, antibiotics     and blood transfusions, and to withdraw blood samples. Treatment will start with induction     chemotherapy, which will include the drugs fludarabine, cyclophosphamide, etoposide,     doxorubicin, vincristine, and prednisone. Some patients may also receive an antibody called     rituximab. Patients will receive one to three cycles of this treatment, depending on their     response to the drugs. (One cycle consists of 5 days on drug therapy followed by a 16-day     rest period.) Several days before the transplant procedure, patients will start conditioning     chemotherapy with cyclophosphamide and fludarabine. Three days after the conditioning therapy     is completed, the stem cells will be infused. To help prevent GVHD, patients will take four     doses of methotrexate (by vein) shortly after the transplant, and cyclosporine (by mouth or     by vein) for about 6 months after the transplant.      The average hospital stay for stem cell transplantation is 3 to 4 weeks. After discharge,     patients will return for frequent follow-up visits for 3 months. Monthly visits will be     scheduled for the next 3 months, then every 3 months for the next 18 months, and less     frequently for a total of at least 5 years post-transplant. These visits will include bone     marrow aspirates and biopsies, blood draws, and other tests to monitor disease status.   "
168898|NCT00048477|"     Nitric oxide gas is important in regulating blood vessel dilation, and consequently, blood     flow. This gas is continuously produced by endothelial cells, which line the blood vessels.     This study will examine whether nitrite, a molecule that normally circulates in the blood     stream, can also dilate blood vessels. The results of this study may be valuable in     developing treatments for people with conditions associated with impaired endothelial     production of nitric oxide, including high blood pressure, high blood cholesterol, diabetes,     estrogen deficiency, and others.      Healthy, non-smoking normal volunteers 21 years of age or older may be eligible for this     study. People who lack the enzyme G6PD or cytochrome B5 in their red blood cells may not     participate. Absence of these enzymes can lead to episodes of sudden shortness of breath and     cyanosis (blueness of the skin due to lack of sufficient oxygen). Participants will undergo     the procedures described in study Parts A and B, as follows:        -  Part A - After numbing the skin, small tubes are placed in the artery and vein at the          inside of the elbow of the dominant arm (right- or left-handed) and a small tube is          placed in a vein of the other arm. The tubes are used for infusing saline (salt water)          and for drawing blood samples. A pressure cuff is placed around the upper part of the          dominant arm, and a rubber band device called a strain gauge is also placed around the          arm to measure blood flow. When the cuff is inflated, blood flows into the arm,          stretching the strain gauge at a rate proportional to the flow. Grip-strength of the          dominant arm is measured with a dynamometer to determine maximum grip-strength. Then,          several measurements of blood flow, nitrite, hemoglobin, and handgrip are made before          and after administration of L-NMMA, a drug that blocks endothelial production of nitric          oxide.        -  Part B - Part A testing is repeated, except that sodium nitrite dissolved in a saline          solution is infused into the artery of the forearm for a few minutes before and during          the hand-grip exercises. In addition, blood samples are drawn before and after each          handgrip exercise to measure methemoglobin, a substance that, at excessive levels, can          cause adverse side effects.   "
169037|NCT00041106|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Biological therapies such as gefitinib may interfere with the growth of the     tumor cells and slow the growth of the tumor. Combining chemotherapy with gefitinib may kill     more tumor cells. Phase II trial to study the effectiveness of combining chemotherapy with     gefitinib in treating patients who have metastatic transitional cell cancer of the urothelium   "
168899|NCT00048490|"     This study will use transcranial magnetic stimulation, or TMS (described below), to treat     epilepsy in certain patients whose seizures persist despite optimum medical treatment. TMS     used in this study is intended to lessen the number of seizures a patient has by decreasing     excitability of the brain in the region where the seizures originate.      Patients between 5 and 65 years of age who have had epilepsy for two or more years and have     had at least one seizure a week for at least 6 months may be eligible for this 18-week study.     Their seizures must come from a neocortical focus-that is, near the surface of the brain.     Candidates will be selected from the NIH Epilepsy clinic and will be screened with an     electroencephalogram (EEG), magnetic resonance imaging (MRI) scans, and blood tests.      Participants will keep a diary of the seizures they experience over an 8-week period. After     the 8 weeks, they will come to the NIH outpatient clinic for 6 consecutive days for the     following procedures:        -  Day 1: A regular clinic visit, plus 6 hours of video-EEG recording (described below)        -  Days 2 through 5: Video-EEG monitoring and TMS as follows:      8:00 - 11: 00 a.m. 3 hours video-EEG monitoring      11:00 - 12:30 p.m. TMS (includes set-up time; actual stimulation time lasts 30 minutes)      12:30 - 3:00 p.m. Lunch + rest      3:00 - 4:30 p.m. TMS      4:30 - 7:30 p.m. 3 hours video-EEG monitoring      (On the fifth day, subjects will have 6 hours of video-EEG monitoring in the afternoon     instead of 3 hours.)      Participants will be randomly assigned to one of two TMS groups. One group will have TMS     delivered in a way that is thought to have a chance of reducing seizures; the other will have     sham, or placebo, stimulation.      When the TMS sessions are completed, participants will keep a diary of their seizures for     another 8 weeks.      Transcranial Magnetic Stimulation      For TMS, an insulated wire coil is placed on the subject's scalp. A brief electrical current     passes through the coil, creating a magnetic pulse that travels through the scalp and skull     and causes small electrical currents in the cortex, or outer part of the brain. The     stimulation may cause muscle, hand or arm twitching, or may cause twitches or temporary     tingling in the forearm, head, or face muscles. During the stimulation, electrical activity     of muscles is recorded with a computer or other recording device, using electrodes attached     to the skin with tape. Some TMS sessions may be videotaped.      Video-EEG Recordings      The EEG recording device is housed in a small pouchlike container that is worn below the     shoulder, attached to a belt worn around the waist.   "
168900|NCT00048503|"     The purpose of this study is to determine if giving tipifarnib after standard treatment will     prevent leukemia from coming back (relapsing). Tipifarnib belongs to a class of drugs called     Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.   "
168901|NCT00048516|"     The objective of this study is to determine whether paricalcitol is safe and effective     compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney     disease.   "
168902|NCT00048529|"     This is a clinical research study of T900607-sodium to determine if it is effective and safe     in treating gastric cancer and adenocarcinoma of the esophagus. Patients will be treated on a     weekly basis with an intravenous injection of the study drug.   "
168903|NCT00048542|"     This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate     adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis     (JIA) who are either methotrexate (MTX) treated or non-MTX treated.   "
168904|NCT00048555|"     To determine what side effects and what clinical effect, if any, the administration of this     investigational product, IDEC-114 in combination with Rituxan® [Rituxan® as a single agent is     approved by the United States Food and Drug Administration (FDA) to treat patients with     relapsed or refractory follicular NHL], has in this patient population.   "
168905|NCT00048568|"     Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667)     in combination with methotrexate is better than methotrexate alone in participants that have     active rheumatoid arthritis and are not responding to methotrexate. The safety of this     treatment will also be studied.      Long Term Extension: The purpose of this amendment is to provide participants who have     completed the initial 12-month double-blind treatment period the opportunity to receive open     label treatment with active drug treatment until abatacept is approved in the local country     or until clinical development has been discontinued.   "
168906|NCT00048581|"     The purpose of this clinical research study is to determine whether abatacept treatment on a     background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of     rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis     factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF     therapy in the last 3 months and did not respond. The safety of treatment with abatacept will     also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months     after the start of the study.   "
168907|NCT00048594|"     A clinical study to determine the efficacy and safety of an investigational medication     (MK0869) in the treatment of depression.   "
168908|NCT00048607|"     A clinical study to determine the efficacy and safety of MK0869 in the treatment of     depression   "
168909|NCT00048620|"     The purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of two dose     levels of weekly intravenous infusions of recombinant human N-acetylgalactosamine 4-sulfatase     (rhASB) for a minimum of 24 weeks in patients diagnosed with MPS VI.   "
168910|NCT00048633|"     The primary objective of this phase II study is to assess if XR9576, a selective MDR-1     inhibitor, is able to reverse primary doxorubicin or taxane resistance in advanced breast     cancer. Clinical activity will be measured by objective tumor response rates observed after     treatment with XR9576 in combination with taxane or anthracycline containing chemotherapy in     patients previously resistant to the same agent(s).      The secondary objectives of the study are to assess the biological activity of XR9576 and     evaluate MDR-1 expression in these tumors. The MDR-1 inhibitory activity of XR9576 will be     evaluated by serial sestamibi scans of the tumor. MDR-1 expression will be detected by     immunohistochemistry.   "
168913|NCT00048672|"     The goal of this clinical research study is to see if imatinib mesylate (Gleevec, STI571) can     improve CML in chronic phase.      Objectives:      Primary Objective:      To increase the proportion of patients achieving a complete cytogenetic response in patients     with Ph-positive early chronic phase CML using initial Gleevec therapy.      Secondary Objective:      To evaluate the duration of cytogenetic response, duration of hematologic response and     survival.   "
169034|NCT00041067|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate     tumor cells and either kill them or deliver tumor-killing substances to them without harming     normal cells. Colony-stimulating factors, such as filgrastim, may help a person's immune     system recover from the side effects of chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with docetaxel,     vinorelbine, and filgrastim in treating women who have stage IV breast cancer.   "
169096|NCT00051389|"     To determine the effects of an angiotensin converting enzyme inhibitor (ACE inhibitor),     fosinopril, on multiple blood markers in 286 adults at high risk for cardiovascular disease.   "
192834|NCT00370721|"     To evaluate the effect of intravitreal bevacizumab on the course of diabetic retinopathy in     cases with the signs of active progressive PDR   "
168914|NCT00048685|"     This study will examine the types of bacteria present in the dental plaque of patients with     persistent dry mouth. Saliva is essential for digestion and swallowing and for maintaining     the normal mineralization of teeth. People who suffer from dry mouth usually have a     significant increase in tooth decay (caries). This study will determine if this increase is     due solely to reduced salivary flow or also to an increase in certain types of bacteria in     the mouth.      Patients participating in the following NIDCR protocols may be eligible for this study:     Evaluation and Treatment of Salivary Dysfunction (84-D-0056), Natural History of Salivary     Gland Dysfunction and Sjogren's Syndrome Research Project (99-D-0070), and Salivary     Evaluation in Normal Volunteers (94-D-0018).      Participants will have three appointments at the NIH dental clinic as follows:      Visit 1      Dental examination and instruction on keeping a detailed diary of food intake.      Visit 2 (1 week after visit 1)      Attachment of a bacteria collection device (described below) to the side of a tooth.      Visit 3 (48 hours after visit 2)      Removal of the collection device, tooth cleaning and polishing, and submission of food diary.      The bacteria collection device is a 4mm x 2mm x 2mm square of sterilized tooth obtained from     slicing an extracted healthy tooth donated by another patient. The donated teeth are either     extracted impacted third molars (wisdom teeth) or teeth extracted for teeth straightening     (orthodontics). The device is heat-sterilized before being bonded to the participant's tooth.     The dental cement used for bonding can be removed after 48 hours with no damage to the     surface of the participant's tooth.   "
168915|NCT00048698|"     This study will examine the effects of direct current (DC) electrical polarization of the     brain on thinking speed, reaction time, mood, and brain waves in healthy individuals. The     results will provide information for designing further studies to examine the safety and     effectiveness of this technique in treating certain brain diseases involving impaired     cognition (thought processing). The study consists of three experiments; participants will     take part in either one or two of the experiments.      Healthy right-handed volunteers between 18 and 80 years of age with 12 or more years of     education may be eligible for this study. Candidates will be screened with a medical and     educational history and a brief neurological examination. Participants in experiments 2 and 3     will also be screened with a verbal fluency test in which they will be asked to say as many     words beginning with certain letters as they can in 1 minute.      Participants will undergo the following procedures for the experiment(s) in which they     participate:      Experiment 1      While resting quietly, subjects receive 20 minutes of weak electrical current stimulation or     sham stimulation with no current. For the stimulation, two gauze pads soaked with a     conducting salt solution are placed on the head-one on the left side and one above the right     eye. The current is passed between the pads and may cause an itching or tingling sensation     under the electrodes. Before and after the stimulation, the participant's reaction     time-tested by moving a finger as fast as possible at the sound of a tone-and mood are     evaluated. Some participants also have an electroencephalogram, or EEG (brain wave recording)     during the experiment. After the stimulation, participants take two brief tests of thinking     speed, and the mood and reaction time tests are repeated.      Experiment 2      The participant sits in a chair with electrodes attached to the muscles that control movement     in a finger on the right hand. Reaction time is tested as described in experiment 1. Then,     transcranial magnetic stimulation (TMS) is used to test the activity of the brain's motor     cortex (the part of the brain that controls movement). For TMS, an insulated wire coil is     placed on the subject's scalp. A brief electrical current is passed through the coil,     creating a magnetic pulse that travels through the scalp and skull and causes small     electrical currents in the brain cortex. The stimulation may cause twitching of the right     hand or arm or produce a mild snapping sensation on the scalp. During the stimulation, the     electrical activity of muscles in the right hand is recorded on a computer. Following the     TMS, DC stimulation is applied, as described in experiment 1. The stimulation begins at a low     level and is followed by repeat TMS and DC stimulation at increasingly higher levels. This     continues until there is a clear effect on the muscle response to the magnetic pulses, or     until the stimulation becomes uncomfortable. At the end of the electrical stimulation,     reaction time is tested again.      Experiment 3      This experiment uses the average DC level that produced a change in the size of the responses     to magnetic stimulation in experiment 2. Thinking speed and reaction time are tested during     the DC stimulation, and the mood test is given before and during the stimulation. This test     does not use TMS or EEG recording.   "
168916|NCT00048711|"     The purpose of the study is evaluate the efficacy, safety, and pharmacokinetics of weekly     intravenous infusions of 1 mg/kg recombinant human N-acetylgalactosamine 4-sulfatase (rhASB)     in patients diagnosed with Mucopolysaccharidosis VI (MPS VI)   "
168917|NCT00048724|"     The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no     treatment for the prevention of disease progression in adult subjects with compensated     cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a     interferon plus ribavirin.   "
168918|NCT00048737|"     The goal of this clinical research study is to see if low intensity chemotherapy given     together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem     cells from a donor can increase the length of remission in patients with leukemia and     lymphoma. The safety of this treatment will also be studied.   "
168919|NCT00048750|"     The purpose of this study is to determine the efficacy and safety of intravenous micafungin     versus placebo as prophylactic therapy for invasive fungal infections in patients in the     intensive care unit considered to be at high risk.   "
168920|NCT00048763|"     Juvenile primary Raynaud’s (ray-knows) Phenomenon is a disorder of the blood vessels in the     fingers and sometimes can affect the toes, nose, or ears. When children with primary     Raynaud’s Phenomenon are exposed to chilly or cold conditions from weather, cold     temperatures, or even holding cold items from the refrigerator, their fingers may become     cold, numb, hurt, and/or turn purple or white. Children with primary Raynaud’s Phenomenon     have no underlying systemic disease. The cause for their symptoms is unknown. The     investigational drug, Pletal(cilostazol), which has been approved for other conditions,     inhibits the ability of one type of blood cell, platelets, to form blood clots, and also     widens narrowed blood vessels. It has been used in a variety of other conditions in which     blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol)     to lessen the severity of the symptoms and decrease the number of primary Raynaud’s episodes     in juvenile patients.   "
168921|NCT00048776|"     Juvenile secondary Raynaud’s (ray-knows) Phenomenon is a disorder of the blood vessels in the     fingers and sometimes can affect the toes, nose, or ears. Children with secondary Raynaud’s     Phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed     connective tissue disease. When children with secondary Raynaud’s are exposed to chilly or     cold conditions from weather, cold temperatures, or even holding cold items from the     refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. The     investigational drug, Pletal(cilostazol), which has been approved for other conditions,     inhibits the ability of one type of blood cell, platelets, to form blood clots, and also     widens narrowed blood vessels. It has been used in a variety of other conditions in which     blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol)     to lessen the severity of the symptoms and decrease the number of secondary Raynaud’s     episodes in juvenile patients.   "
169068|NCT00049296|"     RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Combining thalidomide with docetaxel may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining thalidomide with docetaxel in     treating patients who have advanced cancer.   "
168922|NCT00048789|"     This study will examine the safety and effectiveness of extracorporeal photopheresis (ECP)     for treating chronic graft-versus-host disease (GvHD). GvHD is a common complication of stem     cell transplantation using donated stem cells. It occurs when the donor's T-lymphocytes (a     type of immune cell) see the patient's cells as foreign and mount an immune response to     reject them. The attack can cause skin rash, mouth sores, liver or lung inflammation, lack of     appetite, and muscle stiffness. Chronic GvHD can cause serious illness, and even death, from     the long-term effects of immune dysfunction and from toxic effects of medications (such as     cyclosporine and prednisone) used to treat it.      ECP is an experimental treatment designed to stop the lymphocytes from attacking the body. It     involves collecting some of the cells that cause GvHD, treating them with a combination of     drug and light therapy and returning them to the body. Sixty to 80 percent of patients with     chronic GvHD improve with ECP treatment, and some patients can stop treatment with prednisone     or cyclosporine, or reduce the drug dosages.      Patients with chronic GvHD whose condition has not improved after a minimum 14-day course of     cyclosporine and prednisone may be eligible for this study. Patients must be able to travel     to the NIH Clinical Center in Bethesda, Maryland, twice a week during the 3-month study     period.      Upon entering the study, participants will have a baseline evaluation to measure the extent     of GvHD. This assessment includes blood tests, eye and dental examinations, skin biopsy for     patients with skin involvement, and CT scans and lung function tests to look for possible     lung involvement. Biopsies of the lung, liver, mouth, or eye may be requested if needed to     confirm GvHD in these tissues. The skin will be photographed before starting ECP treatment     and once a month during the treatment period. Following baseline tests, participants will     undergo treatment and evaluations as follows:      ECP Treatment      Patients will have blood drawn to collect lymphocytes causing GvHD. This may be done with a     special needle or catheter (tube inserted into a vein) or for patients who need or prefer it     with a temporary central venous catheter similar to that used for the stem cell     transplantation. Patients will have three 2- to 3-hour treatments a week for the first week     and two treatments a week after that for a total of 25 treatments over 3 months. Patients who     do not tolerate the treatment...   "
168923|NCT00048802|"     This study will compare the effectiveness in the maintenance of continuing adjunctive     atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the     maintenance treatment of adolescents with bipolar disorder.   "
168924|NCT00048815|"     This 6-month study will compare the effectiveness of citalopram (Celexa®), hypericum (St.     John's Wort), and placebo for the treatment of minor depression.   "
168925|NCT00048828|"     This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and     adolescents who have failed standard antipsychotic treatment for schizophrenia.   "
168926|NCT00048841|"     The purpose of this two year study is to examine the safety and effectiveness of alendronate     (Fosamax) for the prevention of bone loss in men with prostate cancer who are on therapy to     lower their testosterone levels. All men will receive appropriate calcium and vitamin D     supplements and one to two years of alendronate therapy. Bone density tests will be done     every six months.   "
168927|NCT00048854|"     This study will determine whether characteristics of women with Premenstrual Syndrome     influence response to treatment with serotonin reuptake inhibitors and whether SRIs can     alleviate premenstrual symptoms.   "
168928|NCT00048880|"     Background:        -  Some cancers, such as Hodgkin's disease, anaplastic large cell lymphoma and others, have          a protein on the surface of the cancer cell called CD30.        -  HeFi-1 is an antibody that binds to the CD30 protein and sends signals to the cancer          cells that can cause them to die.      Objectives:        -  To determine the highest dose of HeFi-1 that can safely be given to patients with tumors          that have the CD30 protein.        -  To determine the response of the tumor to treatment with HeFi-1.      Eligibility:        -  Patients 18 years of age and older with Hodgkin's disease, anaplastic large cell          lymphoma, cutaneous T cell lymphoma and adult T cell leukemia or lymphoma who have signs          of tumor growth or recurrence following standard treatment        -  Patients' tumor cells must have the CD30 protein.      Design:        -  Groups of three patients are treated with increasingly higher doses of HeFi-1 (ranging          from 0.5 to 5 mg/kg) to determine the highest safe dose.        -  HeFi-1 is infused through a vein on 4 days, followed by 2 days of rest over a 10-day          period. Patients may receive up to 2 treatment courses if they show some response and do          not have severe side effects.        -  Blood samples are collected several times during the study to determine safety. A lymph          node biopsy is done at the beginning of the study to test the effect of HeFi-1 on cancer          cells in the test tube, and a bone marrow biopsy may be done at the end of treatment if          the bone marrow was positive for tumor cells at the beginning of treatment.   "
168929|NCT00048893|"     This study will evaluate the effectiveness of chemotherapy and a combination of vaccines to     treat metastatic breast cancer (breast cancer that has spread beyond the breast) in patients     whose cancer cells have a protein called carcinoembryonic antigen (CEA) on their surface.     Patients who require surgery or radiation therapy, or both, will receive these treatments as     well.      Patients 18 years of age and older with previously untreated metastatic breast cancer may be     eligible for this study. Newly diagnosed patients may not have received prior chemotherapy.     Patients previously diagnosed with local disease may have received chemotherapy or radiation     therapy at least 18 months before entering the current study. Patients may have received     hormonal therapy for stage IV disease. Candidates are screened with a medical history and     physical examination, blood and urine tests, x-rays, heart and lung tests, and a test to     determine the presence of CEA on their tumor cells.      Participants undergo the following procedures:        1. Central venous line: Under local or general anesthesia, an intravenous catheter (plastic          tube) is inserted into a major vein in the chest. It is used to give chemotherapy and          other medications and to withdraw blood samples.        2. Apheresis: Before beginning treatment and at various times before and after          chemotherapy, patients undergo apheresis to collect white blood cells for later          re-infusion at the time of immunizations and to evaluate the body's response to the          vaccines. For this procedure, blood is collected through the central venous catheter and          circulated through a machine that separates the white cells from the rest of the blood.          The white cells are removed and frozen for later use. The rest of the blood is returned          to the patient through the catheter.        3. First vaccine: Before starting chemotherapy, patients receive one subcutaneous (under          the skin) injection of a vaccine called rV-CEA-Tricom, along with subcutaneous          injections of granulocyte macrophage colony stimulating factor (GM-CSF) (Sargramostim),          a drug that stimulates the bone marrow to release white blood cells and white cell          precursors into the bloodstream.        4. Chemotherapy:             -  Taxol (paclitaxel)/Cytoxan (cyclophosphamide): Patients receive three to five               cycles of Taxol and Cytoxan. Taxol is given as a continuous 72-hour intravenous               (intravenous (IV), through a vein) infusion and Cytoxan is given daily for 3 days,               intravenously, over 1 hour. Cycles are 21 to 42 (usually 28) days. After each               cycle, patients also receive growth colony stimulating factor (G-CSF) (a drug that               helps boost white cells.   "
168930|NCT00033917|"     The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in     the brain of very low birth weight preterm infants.   "
168931|NCT00033943|"     This study will evaluate the effectiveness and safety of the experimental compound OP2000     (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study     will have received (and will continue to receive) stable doses of aminosalicylates (oral,     enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with     anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the     treatment of ulcerative colitis.   "
169018|NCT00040807|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of irinotecan and docetaxel in treating     patients who have metastatic or locally recurrent head and neck cancer.   "
168933|NCT00033969|"     This study will try to learn more about complex regional pain syndrome, or CRPS (previously     known as reflex sympathetic dystrophy, spreading neuralgia, and sympathalgia), by examining     the release of small proteins in the blood of patients with this condition. Patients with     CRPS usually have three types of symptoms:        -  Sensory abnormalities increased sensitivity to pain or a painful reaction to a harmless          stimulus        -  Perfusion abnormalities alterations in blood flow, temperature abnormality, swelling,          decrease or increased nail growth, and hair and skin changes        -  Motor abnormalities weakness, guarding (Holding the limb in such a fashion that it          minimizes accidental or intentional contact from possible sources of pain), and atrophy          (wasting)      The cause of CRPS is unknown, and there are no definitive diagnostic tests for the condition.     Because early treatment improves the prognosis of CRPS, a test that enables early diagnosis     would be important for optimal medical management. The findings of this study may contribute     to the development of such a test and possibly new drug treatments.      Normal healthy volunteers and patients of any age with complex regional pain syndrome who are     in otherwise good general health may be eligible for this study.      Participants will have a medical history, physical examination and collection of a blood     sample. They will fill out several questionnaires, providing information on their health,     personality, mood, pain levels, and symptoms. Participation in the study requires one     outpatient clinic visit.   "
168934|NCT00033982|"     This study will evaluate the safety and effectiveness of posaconazole for treating invasive     fungal infections. New therapies for these infections are needed for patients who do not     respond, to or cannot tolerate, standard treatment. These patients include those with immune     defects who have significant side effects from treatment with amphotericin or other     antifungals.      Patients 13 years of age or older who are on other primary NIH protocols with an invasive     fungal infection 1) that does not respond to standard antifungal therapies; 2) for which     there is no effective therapy; 3) who develop serious side effects from their current     treatment; or 4) who have organ dysfunction that does not permit use of standard antifungal     treatments may be eligible for this study. Candidates will be screened with a medical     history, including a review of current and previous antifungal treatments, pregnancy test for     women of childbearing potential, electrocardiogram (EKG), and detailed neurologic     examination.      Participants will take either 200 mg (1 teaspoonful) of liquid posaconazole by mouth four     times a day or 400 mg (two teaspoonfuls) twice a day for a period of 28 days to 24 months.     (The physician will determine the duration of treatment.) Patients will have monthly     follow-up visits during the treatment period and 1 month after treatment is completed for the     following procedures:        -  Detailed neurologic exam every 3 months        -  Blood tests every month        -  EKG every month        -  Imaging studies, including chest x-ray, computed tomography (CT), magnetic resonance          imaging (MRI) radionuclide scanning or ultrasound, every month until the infection has          been stable for three determinations. Thereafter, imaging studies will be done every 3          months as long as the infection remains stable or improves.      On the last day of the study treatment period, participants will have a detailed neurologic     exam and review of medications and medical complaints since their last visit.   "
168935|NCT00033995|"     This study will investigate which areas of the brain are primarily involved in and     responsible for tics in patients with Tourette's syndrome and chronic motor disorder.     Tourette's syndrome is a neuropsychiatric disorder characterized by motor and vocal tics and     is associated with behavioral and emotional disturbances, including symptoms of attention     deficit hyperactivity disorder and obsessive-compulsive disorder. Chronic motor disorder has     the same characteristics as Tourette's syndrome, except that patients do not have vocal tics.      Healthy normal volunteers and patients with Tourette's syndrome or chronic motor tic disorder     between 18 and 65 years of age may be eligible for this study. Candidates will be screened     with a medical history and physical and neurological examinations.      Participants will undergo positron emission tomography (PET) scanning to study tics under     three conditions- spontaneous tics, suppression of tics, and sleep-to determine which areas     of the brain are responsible for generation of tics. For this procedure, the subject is     injected with H215O, a radioactive substance similar to water. A special camera detects the     radiation emitted by the H215O, allowing measurement of brain blood flow. Subjects will     receive up to 20 injections of H215O during the scanning.      Participants will be asked not to sleep the entire night before the test. Before the scan,     both patients and volunteers will have EEG electrodes placed on their heads to record the     electrical activity of their brains. Patients will also have EMG electrodes placed in areas     of the body where tics occur. A small catheter (plastic tube) will be placed in an arm vein     for injecting the radioactive tracers, and a mask will be placed on the face to help keep the     head still during scanning. The mask has large openings for eyes, nose and mouth, so that it     does not interfere with talking or breathing. The entire test takes about 4 hours. During     this time, the subject will sleep for 1.5 hours either at the beginning or end of the scan.     For the other 2.5 hours, scans will be done every 10 minutes for 1 minute under the different     conditions of tic suppression or release of tics.      On a separate day, participants will also undergo magnetic resonance imaging (MRI), a     diagnostic test that uses a magnetic field and radio waves to produce images of the brain.     For this procedure, the subject lies still on a stretcher that is moved into the scanner (a     narrow cylinder containing the magnet). ...   "
168936|NCT00034008|"     The purpose of this project is to evaluate whether or not Healing Touch therapy (HT) helps to     treat the stress of babies in the Neonatal Intensive Care Unit (NICU). Healing Touch is a     gentle use of human touch – a light, soft placement without moving of the HT therapist’s hand     on a baby’s body - and energy to create balance and relaxation. The goal of HT treatment is     to help babies rest better, have less pain and discomfort and to heal more quickly. Healing     Touch works along with all the treatments and medicines babies receive as part of ordinary     care in the NICU.   "
168937|NCT00034021|"     The purpose of this study is to provide the first empirical examination of the effects of     Ginkgo biloba (GBE), sex therapy, and a combination of the two on subjective and     physiological measures of sexual function in women who are experiencing sexual disorders     secondary to antidepressants.   "
168949|NCT00039819|"     This study will determine whether stimulating the nerves or the brain can modify the spinal     reflex that controls the muscles that flex and extend the ankle. Training spinal nerve     networks with sensory input may provide a way of re-establishing movements, such as walking,     in patients with spinal injury.      Healthy normal volunteers with no history of peripheral neuropathy or radiculopathy, ankle     contractures or tendon surgery may be eligible for this study. Participants will undergo     three stimulation procedures, each in a different session, to measure leg muscle reflexes.     The procedures are:        -  Reflex testing - Metal electrodes are taped to the skin over the leg muscles. A small          electrical pulse is delivered through the electrodes to stimulate two nerves to the          muscles. This evokes a reflex between the ankle flexor and extensor muscles. The          responses to several dozen stimuli are averaged.        -  Nerve stimulation - The nerve to the muscle that flexes the leg is electrically          stimulated near the knee through electrodes taped to the skin. The strength of the          stimulus is adjusted to produce little or no muscle movement. The stimulation is          repeated every few seconds for 45 minutes.        -  Transcranial magnetic stimulation - An insulated wire coil is placed on the subject's          scalp. A brief electrical current passes through the coil, creating a magnetic pulse          that travels through the scalp and skull and causes small electrical currents in the          outer part of the brain. There may be twitching in the muscles of the arm or leg. During          the stimulation, the subject may be asked to tense certain muscles slightly or perform          other simple actions to help determine the best position for the coil over the part of          the brain that controls the leg. The leg is then stimulated once every 10 seconds,          combined with nerve stimulation every 1 to 2 seconds.   "
169035|NCT00041080|"     Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide     in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or     primary peritoneal cancer. Estrogen can stimulate the growth of some types of cancer cells.     Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen.     Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet     known whether thalidomide is more effective than tamoxifen in treating ovarian epithelial     cancer, fallopian tube cancer, or primary peritoneal cancer.   "
169069|NCT00051025|"     The purpose of this study is to look at the safety and effectiveness of ONTAK in previously     treated patients with NHL.   "
168938|NCT00039650|"     This study will evaluate changes in T cells-infection-fighting white blood cells of the     immune system-in people given a drug called G-CSF before donating stem cells (immature bone     marrow cells) for transplantation. Originally, bone marrow cells were obtained using a needle     inserted into the hipbone of the donor. However, when it was discovered that immature bone     marrow cells also circulate in the blood, scientists began to develop techniques to collect     quantities of these cells from the blood instead of the bone. G-CSF is a blood cell growth     factor that pushes stem cells from the bone marrow into the bloodstream. Stem cell donors are     given this drug 5 to 6 days before donation to make more cells available in the circulating     blood for collection.      Stem cell transplantation requires careful regulation of immune cell function to allow the     donated stem cells to grow in the transplant recipient, to prevent the transplanted cells     from damaging the recipient, and to allow the recipient's new immune system to develop     normally so it can fight infections. Studies comparing the outcome of patients transplanted     with bone marrow cells with those transplanted with stem cells suggest that the G-CSF given     to stem cell donors affects the function of T cells in transplant recipients. This study will     collect white cells containing T cells before and after G-CSF administration to determine the     effects of the drug on both T cells and stem cells.      Healthy normal volunteers 18 years of age and older who meet the health criteria for donating     blood may participate in this study. Pregnant and breastfeeding women are not eligible.      Participants will undergo the following procedures:        -  Blood sample collection (15 milliliters, or 3 teaspoons) to measure blood cell counts        -  Electrocardiogram to assess heart function        -  Apheresis to donate white blood cells. Participants will undergo two apheresis          procedures-once before receiving G-CSF and a second time immediately after finishing the          5-day course of the drug. For this procedure, whole blood is removed using a needle          placed in an arm vein. The blood is circulated through a cell separator machine, where          the white cells are removed and collected in a plastic bag. The rest of the blood,          including the red cells, platelets, and plasma, are returned to the donor through a          needle in the other arm. The procedure takes 2 to 3 hours, during which time the donor          lies quietly.   "
168939|NCT00039663|"     Highly active antiretroviral therapy (HAART) has proven effective in altering the natural     history of HIV infection in many patients. However, this therapy may not be sustainable     because of the toxicities of the medications. Evidence suggests that HIV-infected patients on     HAART may be at risk for premature coronary artery disease. The exact cause is unknown. It is     possible that the medications directly affect the endothelium (the lining of the arteries     that supply blood to the heart) and lead to premature heart disease. Or because the     medications cause lipid abnormalities (high cholesterol) and a condition of relative insulin     resistance, in which the body has a difficult time processing sugars; known risk factors for     endothelial dysfunction and heart disease. Therapeutic intervention that reverses these lipid     abnormalities and/or insulin resistance may lower these risk factors, normalize endothelial     function, and decrease the risk of heart disease.      This protocol aims to assess endothelial function among a group of HIV-infected patients with     varying degrees of viral activity and levels of immune function on a variety of HAART     regimens. It also aims to evaluate the effect of three different medications on lipids,     insulin resistance, and thus endothelial function. Understanding the factors involved in     causing endothelial dysfunction will help better characterize the relative risks and benefits     of early versus late and continuous versus intermittent HAART therapy. The research may offer     some insights into the causes of premature heart disease among HIV-infected patients on HAART     that could be more thoroughly investigated in subsequent clinical trials.      A total of 75 patients will be recruited: 25 for each arm of the study. Each arm evaluates     the potential benefit of a particular medication and will enroll sequentially. An endothelial     function test will be performed on an outpatient basis. The first 25 patients will be     assigned at random to receive pravastatin sodium or placebo; the next 25 will receive     gemfibrozil or placebo; the final 25 will receive rosiglitazone or placebo. Patients will     take the pills for 6 weeks, no pills for the next 4 weeks, and then the opposite treatment     for 6 more weeks. Two weeks after the start of the study drug, blood will be taken to check     for potential toxic side effects. After each 6-week treatment, blood will be drawn and     endothelial function tests will be performed.   "
168940|NCT00039676|"     Background:        -  Individuals may be prone to develop blood or lymph node cancers (leukemia or lymphoma)          for a variety of reasons, including genetic predisposition to these cancers,          environmental exposures or other medical conditions.        -  Studies of people and families at high risk of cancer often lead to clues about their          cause that may also be important regarding the sporadic occurrence of these cancers in          the general population.        -  Identifying genetic or environmental factors that play a role in the development of          these diseases may be important in developing prevention trials, screening programs and          treatments.      Objectives:        -  Describe the cancers and other conditions in families with blood or lymph node cancer.        -  Find and describe genes that may cause blood and lymph node cancer, and understand how          they work in families.        -  Use laboratory methods to try to determine if it is possible to identify who is at          highest risk of blood or lymph node cancer.        -  Test how genes act with other factors to alter the risk of disease, its severity or its          manifestations in families.      Eligibility:        -  Individuals of any age with a personal or family history of a blood or lymph node          cancer.        -  Individuals with a personal or family history of medical conditions or environmental          exposures that may predispose to blood or lymph node cancer.      Design:        -  Participants complete questionnaires about their personal and family medical history and          provide consent for researchers to review their medical records and pathology materials          related to their care and those of deceased relatives with blood or lymph node cancer,          tumors, or other related illnesses for whom they are the legally authorized          representative.        -  Participants donate a sample of blood or cheek cells, or a lock of hair for genetic          studies.        -  Patients may also be evaluated at the NIH Clinical Center by one or more of the          following specialists: cancer doctor or blood specialist, medical geneticist, research          nurses or clinical social worker. They may have blood and urine tests and a cheek swab          or mouth wash to collect cheek cells. Some patients may also be asked to have x-rays and          routine imaging, such as CT scans or ultrasound tests, cell surface markers, skin          biopsy, and, with special consents, bone marrow biopsy, MRI or PET scans, apheresis or          fluorescein angiography and photography.   "
168941|NCT00039689|"     There is evidence that early and aggressive treatment with antiretroviral drugs can prevent     the loss of immune cell function that accompanies HIV infection. This study will use     leukapheresis (drawing blood, separating out the white cells and returning the blood to the     patient) to obtain blood cells from HIV-infected patients in either the acute or chronic     stage of infection who are being treated with early highly active antiretroviral therapy     (HAART). Leukapheresis is necessary to obtain enough cells to delineate the response of B     cells to CD4+ T cell help, the CD8 factors associated with suppression of viral replication     and normalization of immune function, and natural killer function relative to HIV disease.      Study participants will be adult (older than 18 years) HIV primary or acutely affected     patients (those with a history of exposure to HIV but not yet showing chronic symptoms of HIV     disease) and HIV chronically infected patients (those infected with HIV for longer than 12     months or showing other symptoms of HIV disease) who are not receiving HAART at the beginning     of the study. The study seeks to enroll 30 primary and 30 chronic patients. Pregnant women     will not be enrolled in the study; women who become pregnant will be dropped from the study.      Leukapheresis will be performed on each patient before HAART therapy begins and then three     times a year. Each session will take between 1 and 3 hours.      This longitudinal study will enable researchers to examine the function of certain B cells,     natural killer cells, and CD8+ T cells in people who do not have chronic HIV disease and in     those who do have the disease and are treated with HAART.   "
168957|NCT00039936|"     This is a multicenter (2 sites) randomized trial evaluating three group treatment models for     subjects with binge eating disorder. One model is a cognitive behavior treatment (CBT) group,     one is partial self help, and one is self help only.   "
169019|NCT00040820|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Clinical trial to study the effectiveness of oxaliplatin in treating patients who     have locally advanced or metastatic colorectal cancer that has been previously treated.   "
169020|NCT00040833|"     RATIONALE: Acupuncture and acupressure may help relieve moderate or severe pain associated     with stage III or stage IV pancreatic cancer.      PURPOSE: Phase II trial to study the effectiveness of acupuncture and accupressure in     treating patients who have moderate or severe pain associated with stage III or stage IV     pancreatic cancer.   "
169091|NCT00051324|"     The purpose of this trial is to study early brain and behavioral changes in people who have     the gene expansion for Huntington's disease, but are currently healthy and have no symptoms.   "
168942|NCT00039702|"     The purpose of this study is to use brain imaging technology to examine the role of certain     brain chemicals in individuals with Alzheimer's disease (AD) and in healthy volunteers.      Cognitive dysfunction in people with AD is thought to arise from decreased chemical activity     in specific parts of the brain. Decreases in alpha4beta2 nicotinic acetycholine receptors     (nAChRs) have been found in the brains of people who died with AD; however, the status of     this receptor system in living brains remains unclear. This study will use single photon     emission computed tomography (SPECT) to study this receptor system in people with AD who have     mild to moderate dementia and in healthy volunteers. In addition, this study will examine the     relationship between cognitive dysfunction and nAChR deficits in the brains of individuals     with AD.      Participants with AD will have four clinic visits; healthy volunteers will have three visits.     At Visit 1, participants will undergo a medical history, physical examination, and laboratory     tests. Healthy volunteers will have a Mini-Mental State Examination (MMSE) cognitive function     test. Participants with AD will have a MMSE and measurement of the severity of their     dementia.      During Visit 2, participants will undergo a magnetic resonance imaging (MRI) scan of the     brain.      At Visit 3, participants will undergo SPECT imaging.      Only participants with AD will participate in Visit 4. During this visit, cognitive testing     will be performed.   "
168943|NCT00039715|"     The purpose of this study is to determine whether people who develop Post-Traumatic Stress     Disorder (PTSD) after a trauma have increased sensitivity to the effects of a stress hormone.      Patients with PTSD have small hippocampal volume and deficits in hippocampal-mediated memory     as compared to healthy people. However, it is unclear whether the smaller hippocampi are a     consequence of PTSD or a risk factor for the development of PTSD. Some researchers believe     that people who develop PTSD have an increase in cortisol levels during traumatic experiences     and that this could be neurotoxic to the hippocampus. Others hypothesize that increased     sensitivity of glucocorticoid receptors to cortisol, regardless of the cortisol levels, could     lead to neurotoxic damage to the hippocampus. This study will compare responses to a stress     hormone in patients with PTSD, participants who have experienced trauma but do not have PTSD,     and healthy volunteers.      Participants will be screened with a medical and psychiatric interview, physical examination,     blood tests, electrocardiogram, and an emotional intelligence evaluation. Those eligible for     the study will be asked to collect urine and saliva samples for 3 days. Participation will     also include blood draws, a PET scan (brain imaging), an eye-blink test, neuropsychological     testing, and other procedures.      At another study visit, participants will undergo a magnetic resonance imaging (MRI) scan     (brain imaging), questionnaires, and other procedures.   "
168944|NCT00039741|"     Little is known about what treatment combinations are best for HIV infected children. This     study examined the long-term effectiveness of different anti-HIV drug combinations in     children and strategies for switching treatment if the first treatment does not work. The     study enrolled children who had not previously taken anti-HIV medication. Participants in     this study were recruited in the United States, South America and Europe.      Some European children may also enroll in a substudy that will observe changes in body fat in     children taking anti-HIV medications.   "
168945|NCT00039754|"     Multiple myeloma is a disease that resides primarily in the bone and has shown to be     sensitive to radiation. Administration of a radiotherapy agent that targets the bone, such as     Holmium-166-DOTMP, in conjunction with melphalan and an autologous stem cell transplant, may     improve the patient's chance of responding to treatment. The purpose of this study is to     determine the amount of Holmium-166-DOTMP that localizes in the bone and in normal organs,     and to evaluate the safety and efficacy of Holmium-166-DOTMP in the treatment of patients     with multiple myeloma.   "
168946|NCT00039767|"     This study will compare the effectiveness of two blood thinners, heparin and lepirudin, in     preventing withdrawal occlusion (blockage) in a venous access device (VAD). A VAD is a     catheter (plastic tube) placed in a vein beneath the collarbone to deliver medication and     withdraw blood samples during treatment. The device may become clogged, possibly by formation     of a clot around the tip, blocking its opening and making it difficult or impossible to use.     The clot can be dissolved by a medication called tPA. The blood thinner heparin has been used     for many years to try to prevent the blockage from occurring, but it is still a problem in as     many as 25 percent of VADs. This study will test whether a new blood thinner called lepirudin     is more effective than heparin in preventing withdrawal occlusion caused by a small clot.      Patients 21 years of age and older who are enrolled in NIH protocols at the Clinical Center     and who require tunneled, open-ended VADs for their medical care may be eligible for this     study. Candidates must expect to receive all of their primary medical care at the Clinical     Center during the first 4 weeks after their VAD is inserted and most of their care at the     Clinical Center for the next 3 months.      Participants will be randomly assigned to receive either heparin or lepirudin flushes for the     first 3 or 4 weeks after placement of their VAD-the period during which withdrawal occlusion     is most likely to occur. After this period, all patients will use routine heparin flushes     until the VAD is removed.      The patient's VAD will be closely monitored for withdrawal occlusion during the 3- to 4-week     test period and will continue to be observed for up to 3 months to check for lasting effects     of the blood thinner.   "
168947|NCT00039780|"     The purpose of this study is to determine whether BNP7787 is effective in preventing or     reducing neurotoxicity (nerve damage) caused by paclitaxel (Taxol®).   "
168948|NCT00039793|"     The purpose of this study is to develop methods for studying the effect of bodywork therapy     on symptoms of fatigue in patients undergoing cancer chemotherapy.   "
168973|NCT00040183|"     The purpose of this study is to determine if OSI-774 will improve overall survival when     combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with     pancreatic cancer.   "
168974|NCT00040196|"     This study has two purposes: 1) to understand the effect of a decline of dopamine in the     brain during normal aging and in patients with Parkinson's disease, and 2) to investigate how     medicines used to treat Parkinson's disease improve movement performance in patients.      Patients with Parkinson's disease have difficulty performing precise finger movements, mainly     because of a dramatic decrease of a substance called dopamine in parts of the brain.     Medicines such as levodopa, which help restore dopamine levels, can greatly improve function;     however, little is known about how these drugs work. In normal aging, dopamine decreases     slightly in certain parts of the brain, but the importance of this decline is poorly     understood. This study may provide new information about Parkinson's disease and normal aging     that might lead to better treatment strategies.      Patients with mild to moderate Parkinson's disease and healthy volunteers 21 years of age and     older may be eligible for this study. All participants must be right-handed. All candidates     will be screened with a medical history and physical and neurological examinations, including     memory tests and mood examination.      Brain function will be studied using functional magnetic resonance imaging (fMRI) study and     positron emission tomography (PET). Participants may be asked to stop using medications that     can affect the central nervous system, such as sleeping pills or drugs for depression or     anxiety, for 1 week before each study visit. Patients with Parkinson's disease may also be     asked to stop using antiparkinsonian medications at least 12 hours before each visit. In     addition, all participants will be asked to abstain from alcoholic beverages at least 24     hours before the fMRI and PET scans, and from nicotine and caffeine for at least 12 hours     before the scans.      Participants will have fMRI, which uses a strong magnetic field and radio waves to create     images of the brain. The subject lies on a table in a tunnel-like cylinder (the scanner) for     1 to 2 hours, lying still for 5 to 15 minutes at a time. He or she can communicate with the     technician or researcher at all times during the test through an intercom system. Scans will     be done while the subject is at rest and while he or she is performing finger movements. The     movements involve pushing five buttons on a box-each button every 3 seconds on average in a     specific order. Patients with Parkinson's disease will be studied off- and then on-     medications that restore the levels of levodopa in the brain.      Some participants may be asked to undergo a PET scan on a separate visit. A PET scanner is a     doughnut-shaped machine similar in appearance to a CT (computed tomography) scanner. PET     scans detect radioactivity used to provide information on brain activity. Before the test     begins, subjects are given a dose of carbidopa-a medicine that increases the amount of     levodopa in the brain. A catheter (thin, plastic tube) is then inserted into an arm or wrist     vein, and a radioactive form of levodopa called 18Fluorodopa is injected through the     catheter. A moldable plastic mask with large openings for eyes, nose, and mouth is placed on     the face to help keep the head still during scanning. The total scan time is 2 hours or less.   "
168975|NCT00040209|"     This study will evaluate the effects of an experimental drug called JP-1730 on Parkinson's     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of     long-term treatment with levodopa. JP-1730 affects chemical messengers believed to affect     Parkinson's disease symptoms.      Patients between 30 and 80 years of age with relatively advanced Parkinson's disease may be     eligible for this 3-phase study.        -  Phase 1 - Baseline evaluation      Participants will be evaluated with a medical history, physical examination, detailed     neurologic evaluation, routine blood tests, urinalysis and an electrocardiogram. They will     also have a 24-hour holter monitor (heart monitoring) and cardiology consultation. A chest     X-ray and MRI or CT scan of the brain will be done if needed. Patients will, if possible,     stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before     the study begins and throughout its duration. (If necessary, patients may use short-acting     dopamine agonists, such as Mirapex and Requip.)        -  Phase 2 - Dose Finding Phase      For 2 to 3 days, patients will be admitted to the NIH Clinical Center for a levodopa (a     dopamine agonist) dose-finding procedure. For this procedure, patients stop taking Sinemet     and instead have levodopa, and subsequently apomorphine, infused through a vein. During the     infusions, the drug dose is increased slowly until either 1) parkinsonian symptoms improve,     2) unacceptable side effects occur, or 3) the maximum study dose is reached. Symptoms are     monitored frequently to find the optimal dose. (Patients who have had dosing infusions in the     last 3 months will not have to undergo this phase of the study.)        -  Phase 3 - Active Study Phase      Within 3 months of the dose-finding phase, treatment will begin. Patients will receive seven     doses of JD-1730 or placebo (an inactive substance) via puffs from an oral spray together     with levodopa infusions over a 3-week period. The doses are given on days 1, 2, and 3 of the     first week and then approximately twice a week for the next 2 weeks. For these doses,     patients are hospitalized 4 days the first week and 2 days each for the next 2 weeks. All     participants will receive placebo at some time during the study, and a few patients, selected     at random, will receive only placebo the entire 3 weeks. The procedure for the infusions is     the same as that for the dose-finding phase, with frequent evaluation of symptoms. Also,     small blood samples are drawn up to three times each study day. At the end of the third week,     patients will be discharged from the hospital. Their anti-parkinsonian medications may be     readjusted, as needed. Patients will be contacted 2 weeks after the end of the study for a     check on side effects and, if necessary, will be scheduled for a follow-up evaluation at the     clinic.      In addition to the above procedures, patients will be asked to have an optional lumbar a     puncture (spinal tap) on the first and last days of the study to measure various brain     chemicals and drug levels that cannot be measured in blood and urine. For this procedure, a     local anesthetic is given and a needle is inserted in the space between the bones (vertebrae)     in the lower back. About 2 tablespoons of fluid is collected through the needle.   "
168976|NCT00040222|"     Individuals and families with known or suspected syndromes that include breast, ovarian or     genetically-related cancers are enrolled in this family study, which is a syndrome-specific     sub-set of the long-standing DCEG Human Genetics Program umbrella family studies protocol     (78-C-0039). Cancer outcomes are documented through review of medical, vital, and pathology     records. Selected individuals and family members are asked to complete questionnaires to     assess etiologic risk factors and to undergo clinical evaluations specifically tailored to     the relevant familial syndrome. Study participants are monitored prospectively for the     development of outcomes of interest, typically by means of periodic mail or telephone     contact. In selected instances, subjects may return to the Clinical Center periodically for     study-specific follow-up examinations. Study participants are asked to donate biologic     specimens to be used in the laboratory search for cancer etiology and mechanisms of     carcinogenesis. DNA and serial serum samples will be collected. Tumor tissue will be obtained     whenever feasible.      Clinical genetic testing for tumor susceptibility gene(s) mutations and risk notification     will be offered consistent with ASCO guidelines when reasonable individual cancer risk     estimates can be delivered, and only to those participants who choose to know their     individual genetic status after appropriate education and counseling. The testing will be     conducted exclusively in Clinical Laboratory Improvement Amendments (CLIA)-licensed     laboratories. Clinical genetic testing and risk notification are entirely optional and do not     affect subject eligibility for other aspects of the protocol. A separate consent procedure     and consent form will be used for genetic testing and risk notification.      This protocol, developed in response to recommendations developed by the Clinical Center IRB,     is intended to:        1. Provide a mechanism under which the Clinical Genetics Branch can honor the commitment          made to the members of over 60 hereditary breast/ovarian cancer families which have been          participated in various Human Genetics Program research studies conducted over the past          3 decades to provide genetic counseling,           clinical germline mutation testing, and consultative services now that several of the          major breast/ovarian cancer susceptibility genes have been identified;        2. Provide a mechanism through which new families with various familial syndromes          associated with an increased risk of breast and ovarian cancer can be studied, as          research interests in these syndromes evolve over time; and        3. Create a resource of well-characterized, carefully documented high-risk families to          facilitate the development of new etiologic and translational research studies in the          future.      While we do not offer specific anti-cancer therapy as part of this protocol, we provide     assistance to ensure that study participants who require treatment for problems that develop     during the course of the study are referred to appropriate health providers. We      remain available to provide advice and consultation related to the management of the familial     cancer syndrome to study participants and their health care providers.   "
169047|NCT00048971|"     RATIONALE: Genetic testing may help predict how patients will respond to chemotherapy drugs     and may help doctors plan more effective treatment with fewer side effects.      PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients     with stage III colon cancer who are receiving chemotherapy.   "
169048|NCT00048984|"     Diagnostic trial to study genetic differences in patients who have Ewing's sarcoma. Genetic     testing may help predict how cancer will respond to treatment and allow doctors to plan more     effective therapy.   "
168950|NCT00039832|"     This study will evaluate the safety and effectiveness of two types of blood thinners,     abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after     ischemic stroke (stroke resulting from a blood clot in the brain).      The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the     clot buster drug rt-PA. This treatment, however, is effective only if begun within 3 hours of     onset of the stroke and most patients do not get to the hospital early enough to benefit from     it. There is thus a pressing need to develop effective stroke treatments that can be     initiated more than 3 hours after onset.      Patients between 18 and 80 years of age who have experienced a mild or moderate acute stroke     between 3 and 24 hours before starting study drugs may be eligible for this study. Candidates     will be screened with a physical examination, blood tests and a magnetic resonance imaging     (MRI) scan (if an MRI was not done during the stroke evaluation).      All participants will receive ReoPro. Some will also receive Retavase, which may boost the     effectiveness of ReoPro. Retavase is administered in a single dose through a needle in the     vein over 2 minutes. ReoPro is infused into the vein over 12 hours. Patients will be     monitored with physical examinations, blood tests, computed tomography (CT) scans, and three     or four MRI scans of the brain to evaluate both the response to treatment and side effects of     the drugs. An MRI scan will be done 24 hours, 5 days and 30 days after starting the study     medication, and possibly during screening for this study.      CT involves the use of specialized x-rays to obtain images of the brain. The patient lies     still in the scanner for a short time while the X-ray images are formed. MRI uses a strong     magnetic field and radio waves to demonstrate structural and chemical changes in tissue. MRI     is more sensitive than x-ray in evaluating acute stroke. The patient lies on a table in a     metal cylinder (the scanner) while the pictures are being taken. During part of the MRI, a     medicine called gadolinium contrast is injected in a vein. This medicine brightens the     images, creating better pictures of the blood flow.   "
168951|NCT00039845|"     This study will use magnetic resonance imaging (MRI) to investigate language function in     children-that is, how language skills such as naming objects, understanding spoken language     and reading are organized in the brain. The study focuses on children between 4 and 7 years     old. Children 8 to 12 years old and adults will be studied before the younger children to     test study paradigms appropriate for pre-literate children. The results of this study will     help evaluate the usefulness of MRI in identifying language function and location and may     improve the treatment of children with seizures.      Right-handed, native English-speaking adults and children between 4 and 12 years of age may     be eligible for this study. Candidates will be screened with a routine neurological     examination. Children will also undergo neuropsychological testing (standard tests of     language, memory, perception and attention) either at the screening visit or at a later time.     Parents will fill out a form to identify children with attention deficit and hyperactivity     disorders. These children will be excluded form the study.      All participants will undergo MRI scanning of the brain while performing a task designed to     test a language skill, such as identifying a picture or listening to or reading a word. The     MRI detects changes in blood properties in the areas of the brain that perform each task.     Before the MRI, children will be rehearsed for the tests and will have a session in the     scanner to know what to expect and feel more at ease during the actual test. The time in the     MRI machine is usually between 15 and 20 minutes, but will be no more than 40 minutes for     children 8 to 12 years old, and not more than 20 minutes for younger children. Children may     be requested to have up to five MRI sessions to test different brain functions or confirm     findings.   "
168952|NCT00039858|"     The purpose of this study is to evaluate the safe and effective dose of Argatroban for     prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous     diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who     in the opinion of the investigator require alternative anticoagulation due to an underlying     condition.   "
168953|NCT00039871|"     The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus     REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to     severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha     interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus     REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the     effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease     progression (Protocols P02569 and P02570).   "
168954|NCT00039884|"     This is a clinical trial (a type of research study) designed to describe the efficacy     (effectiveness) and toxicity (safety) of a new medical treatment, NESP (Novel Erythropoiesis     Stimulating Protein). This study will be offered to patients with cervical cancer undergoing     a combination of chemotherapy and radiation. This treatment may lower your red blood cells.     The use of NESP may stimulate the body to produce more red blood cells. Our hypothesis is     that higher red blood cells will be beneficial to the patient during treatment for cervical     cancer.   "
168955|NCT00039910|"     Intensive chemotherapy is associated with significant thrombocytopenia, often requiring     platelet transfusion to maintain platelet counts. This investigational drug has been     demonstrated to increase platelet counts. This study will test the safety and efficacy of the     investigational drug in the prevention of thrombocytopenia in patients with recurrent or     refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL), or     Hodgkin's disease receiving DHAP (Dexamethasone, high-dose Cytarabine, and Cisplatin)     chemotherapy.   "
168956|NCT00039923|"     This study will examine blood cells of patients with paroxysmal nocturnal hemoglobinuria     (PNH) after they receive a blood transfusion to determine if certain proteins (GPI-linked     proteins) in the transfused blood transfer to the patient's blood cells. GPI-linked proteins,     which are normally present on red cells and regulate red cell survival, are absent in     patients with PNH. Their lack is believed to account for the premature destruction of red     blood cells in these patients, resulting in a low hemoglobin and hematocrit. Patients may     experience fatigue, flank pain and other symptoms, requiring treatment with blood     transfusion.      Patients with PNH 18 years of age or older with group A1 blood who require at least three     units of red cells and who have not been transfused with group O blood within the last 3     months may be eligible for this study.      Participants will come to the NIH Clinical Center for the following procedures:        -  Interview about the severity of their anemia-related symptoms        -  Blood test        -  Blood transfusion, if required. Patients will be transfused with compatible group O          blood. The donor blood will be washed (rinsed with a salt solution) until it is 99% free          of donor plasma. Group O blood is given instead of group A1 in order to be able to          distinguish the patient's cells from the transfused cells.      Blood samples of 3 teaspoons each will be drawn 1 day, 1 week, and 3 weeks after the     transfusion. These samples may be collected by the patient's doctor locally and sent to NIH     by mail.      If it is found that GPI-linked proteins transfer to the patient's cells, the study will also     examine how long the proteins remain attached and will assess whether the proteins are     functional and prevent cell destruction.   "
168958|NCT00039962|"     Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the     United States. Approximately one-third of patients with hepatitis C infection develop     cirrhosis of the liver, which can lead to liver failure or liver cancer. The current     treatment for hepatitis C infection in previously untreated patients is successful in only     about half of patients. There is no established therapy for non-responders.      This is a randomized, double-blinded, multicenter trial to determine the effectiveness of     thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk     compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C with early     cirrhosis or progression to cirrhosis who are non-responders to previous treatment with     interferon or interferon plus ribavirin. The definition of non-response requires a positive     HCV RNA test at the end of a course of at least 12 weeks of therapy. Patients will receive     treatment for 12 months, and will be followed-up for a further 6 months after the end of     therapy   "
168959|NCT00039975|"     Diltiazem CD and amlodipine are drugs used to treat heart disease and high blood pressure.     The purpose of this study is to find out if these drugs interact with the anti-HIV drugs     indinavir and ritonavir. The study will also look at the safety of taking the study drugs     together.      Heart disease and high blood pressure are major health concerns for people with HIV. Standard     treatment for these illnesses often includes calcium channel blockers (CCBs). There is a     potential for significant drug interactions between CCBs and HIV protease inhibitors (PIs)     that may influence the dosing, monitoring, and choosing of CCBs and PIs when used in people     infected with HIV. This study will examine the drug interactions between 2 commonly used CCBs     and the PI combination indinavir and ritonavir (IDV/RTV). This information should help     doctors choose the appropriate treatment for high blood pressure or heart disease in people     taking PIs.   "
168960|NCT00039988|"     The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone     compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS).      MS is thought to be an autoimmune disease of the central nervous system. Certain white blood     cells of the immune system become abnormally active and mistakenly attack the myelin of nerve     fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like     insulation around an electrical wire. Without proper myelin insulation, messages sent between     the brain and other parts of the body may be confused or fail completely. Damage to myelin     causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR),     where partial or total recovery occurs after attacks. Four therapies are currently approved     for the treatment of MS. These therapies, however, are only moderately effective and can     cause undesirable side effects. For this reason, there is a need to find new therapies that     have minimal side effects and may stop the disease from getting worse.   "
168961|NCT00040001|"     This study is designed to evaluate the safety of DTI-0009 in patients with atrial     fibrillation and to find the dose of DTI-0009 that lowers heart rates in patients with atrial     fibrillation with rapid ventricular response.   "
168962|NCT00040014|"     The purpose of this study is to find out if the two different formulations of exemestane     (Aromasin), oral and injectable, are equivalent in terms of pharmacodynamics and     pharmacokinetics, i.e., if ultimately both formulations have the same efficacy in     postmenopausal women with metastatic breast cancer who have failed previous antiestrogens     therapy and are equally safe.   "
168963|NCT00040027|"     Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the     United States. Approximately one-third of patients with hepatitis C infection develop     cirrhosis of the liver, which can lead to liver failure or liver cancer. The current     treatment for hepatitis C infection in previously untreated patients is successful in only     about half of patients. There is no established therapy for non-responders.      This is a randomized, double-blinded, multicenter trial to determine the effectiveness of     thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk     compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C without     cirrhosis who are non-responders to previous treatment with interferon or interferon plus     ribavirin. The definition of non-response requires a positive HCV RNA test at the end of a     course of at least 12 weeks of therapy. Patients will receive treatment for 12 months, and     will be followed-up for a further 6 months after the end of therapy.   "
168964|NCT00040040|"     The purpose of this study is to assess potential interactions between intravenous (IV)     methamphetamine and oral bupropion.   "
168965|NCT00040053|"     The purpose of this study is to assess ondansetron for the treatment of methamphetamine     dependence.   "
168966|NCT00040066|"     The purpose of this study is to assess the development of human laboratory study model of     cocaine relapse prevention.   "
168967|NCT00040092|"     Virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's     immune system, which in turn may slow the growth of tumors. It is presented in vials as a     sterile preparation for IM injection. The purpose of the trial is to investigate if Virulizin     in combination with gemcitabine provides better efficacy than gemcitabine alone (with     placebo) against pancreatic cancer.Virulizin® efficacy will continue to be assessed if     chemotherapy is changed to 5-Fluorouracil.   "
168968|NCT00040105|"     The goal of this clinical research study is to find the highest safe dose of the drugs     ZarnestraTM (R115777) and Gleevec (imatinib mesylate) that can be given in combination for     the treatment of chronic myelogenous leukemia (CML) in chronic phase. The effect of this     combination on the leukemia will also be studied.   "
168969|NCT00040131|"     The purpose of this study is to determine if a single dose of IL-10 compared to placebo is     safe and effective in reducing the incidence of post-ERCP acute pancreatitis for subjects     with increased risk.   "
168970|NCT00040144|"     The purpose of this study is to determine the safety and antiviral HBV activity of ACH126,     433 (b-L-Fd4C) in the treatment of adults with lamivudine-resistant chronic Hepatitis B.   "
168971|NCT00040157|"     To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection     who have modestly detectable viral load while on stable triple combination antiretroviral     therapy including 3TC.   "
168972|NCT00040170|"     This study involves the use of an experimental product, TG4010. The purpose of the study is     to determine if TG4010 can stimulate the body's immune system to help it fight the cancer.   "
169088|NCT00051285|"     To determine if low-dose enoximone therapy is an effective treatment for advanced chronic     heart failure.   "
168977|NCT00040235|"     This study will determine whether magnesium replacement during apheresis can decrease side     effects that donors commonly experience. Apheresis is a method of collecting large numbers of     certain blood cells, such as white cells, stem cells, or platelets. In this procedure, whole     blood is collected through a needle in an arm vein, similar to donating blood. The blood is     separated into its components by centrifugation (spinning), the required cells are extracted,     and the rest of the blood is returned to the body, either through the same needle or through     another needle in the other arm.      When healthy people donate cells by apheresis, a blood thinner called citrate is added to     prevent the blood from clotting in the apheresis machine. Citrate works by reducing calcium     in the blood. When the blood is returned to the donor, citrate from the machine is also     returned, lowering the donor's calcium levels. As a result, donors often feel tingling around     the mouth, hands, and feet. Some of these symptoms can be prevented by giving calcium     intravenously (through a vein) during the procedure. Even with the added calcium, however,     some donors still have symptoms. Magnesium levels are also lowered by citrate, but it is not     known if this causes symptoms. This study will examine whether the decrease in magnesium     levels also contributes to the side effects of apheresis and whether magnesium replacement     can reduce these symptoms.      Healthy apheresis donors 18 years of age or older who are enrolled in NIH protocols may     participate in this study.      Donors will undergo the apheresis procedures required by the NIH protocol they are enrolled     in. Throughout the procedure, they will receive an intravenous infusion of a salt solution     that may or may not contain magnesium. Blood samples of 5 milliliters (1 teaspoon) each will     be taken from the apheresis machine at the beginning and end of the procedure and at 30- to     60-minute intervals during the procedure. No more than 50 ml (3 tablespoons) will be taken     during any single apheresis. The last sample will be drawn 60 minutes after completion of the     apheresis. In addition, donors will:        -  Provide a urine sample at the beginning and end of each apheresis procedure.        -  Donate an additional urine sample and an additional 5 ml blood sample the morning after          apheresis        -  Describe any symptoms experienced during apheresis to the apheresis nurse   "
168978|NCT00040248|"     This study will examine the safety and effectiveness of daclizumab (also called Zenapax or     anti-CD25) in patients with Wegener's granulomatosis, a type of vasculitis (blood vessel     inflammation). Wegener's granulomatosis can affect many parts of the body, including the     brain, nerves, eyes, sinuses, lungs, kidneys, intestinal tract, skin, joints, heart, and     other sites. Standard treatment is a combination of prednisone and a cytotoxic agent (a drug     that interferes with cell growth), usually cyclophosphamide or methotrexate. However, many     patients treated with this regimen have a disease relapse, and others cannot take these drugs     because of severe side effects. This study will focus on the effectiveness of daclizumab in     preventing disease relapse.      The Food and Drug Administration approved daclizumab in 1997 for preventing kidney transplant     rejection, and the drug has also been studied in people with an eye infection called uveitis.     The drug works by binding to a protein on T lymphocytes (white blood cells of the immune     system) called CD25. This prevents another protein, called interleukin-2, from binding to     this site, thereby preventing a series of events that normally results in inflammation.      Patients between 10 and 75 years of age with Wegener's granulomatosis may be eligible for     this study.      Participants will have a medical history review and physical examination, including     laboratory studies. If medically indicated, x-rays, consultations and biopsies (surgical     removal of a small tissue sample) of affected organs will also be conducted. All patients     will begin treatment with prednisone and cyclophosphamide daily. Those who improve on this     regimen will reduce the prednisone gradually and continue with cyclophosphamide until their     disease is in remission. While taking cyclophosphamide, patients must have blood and urine     tests done every 1 to 2 weeks. Those who achieve disease remission will stop cyclophosphamide     and start taking methotrexate once a week, usually by mouth but possibly by injection into     the muscle or skin. Blood and urine tests will be conducted once a week for 4 weeks while the     dosage is being adjusted and then once a month for the duration of treatment. Patients on     methotrexate whose prednisone dose is reduced to 10 to 30 mg every other day will be randomly     assigned either to receive or not receive daclizumab in addition to the methotrexate.     Daclizumab is given intravenously (through a plastic tube inserted into a vein) the day after     the randomization, then again in 2 weeks, 4 weeks, and once a month for 18 months.      All patients will continue to taper their prednisone dose until it is stopped. Methotrexate     will continue for 2 years. Patients whose disease remains in remission at this time will     decrease the methotrexate dose. If there is no active disease when both prednisone and     methotrexate have been stopped, no further treatment will be given. If disease recurs at a     later time, treatment will be reinstituted. The treatment will be determined by the severity     of disease, other medical conditions, and history of side effects. Patients not randomized to     daclizumab who relapse while still taking methotrexate may be offered re-treatment with     daclizumab.      Patients will be evaluated in the outpatient clinic every 4 to 8 weeks until randomization.     Patients not taking daclizumab will be followed every 4 to 12 weeks; those taking the drug     will be seen every 2 weeks for the first month, every month after that during the 18-month     treatment period, and every 4 to 12 weeks until all medications stop. Follow-up evaluations     include a physical examination, blood draws and, if medically indicated, X-rays. The total     study duration is 60 to 70 months.   "
168979|NCT00040261|"     The purpose of this study is to determine the safety and effectiveness of the drug memantine     for treating major depression.      Major depression is a serious public health concern that contributes to significant morbidity     and mortality. Despite the availability of a wide range of antidepressant drugs, a proportion     of patients with major depression fail to respond to first-line antidepressant treatment,     despite adequate dosage, duration, and compliance. Recent studies suggest that the     glutamatergic system may play a role in the pathophysiology and treatment of depression.     Memantine and other agents which reduce glutamatergic neurotransmission may represent a novel     class of antidepressants.      The study consists of three phases. In Phase 1, participants will be tapered off all     psychiatric medications over a 2-week washout period. In Phase 2, participants will be     randomly assigned to receive either memantine or placebo (an inactive pill) three times a day     for 8 weeks. Participants who do not respond to the treatment after 8 weeks will be taken off     the study and offered standard treatment. Weekly psychiatric evaluations will evaluate     treatment response. During Phase 2, participants who respond well to treatment will enter     Phase 3, a 16-week continuation phase of either memantine or placebo. Interviews will be     conducted every other week in the first month , then monthly thereafter.      Participants will have a physical examination, neuropsychological tests, and eye blink tests     at baseline and at the end of the study. Pulse, blood pressure, and blood samples will be     taken throughout the study. Participants will undergo an electrocardiogram as well as     positron emission tomography (PET) and magnetic resonance imaging (MRI) scans of the brain.   "
168980|NCT00040274|"     The purpose of this study is to evaluate DPC 817. The safety, dosages, and how the body     responds to the drug will be studied.   "
168981|NCT00040287|"     The purpose of this study is to examine a new theory for understanding the processes that     govern behavior change by observing how people’s beliefs and feelings about smoking cessation     or weight loss change as they participate in smoking cessation or weight control programs.     This study also seeks to improve the ability of treatment programs to help people maintain     changes in their behavior.   "
168982|NCT00040300|"     The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how     the body reacts to Racivir will be studied.   "
168983|NCT00040313|"     The purpose of the study is to determine whether pegaptanib sodium (Macugen) is safe and     effective in slowing the leakage of fluid within the retina and thereby stabilizing or     improving vision when compared to placebo injections. A total of 176 patients will be     enrolled   "
168984|NCT00040326|"     The purpose of this trial is to compare the effectiveness of early surgical intervention for     mesial temporal lobe epilepsy to continued treatment with antiepileptic drugs.   "
168985|NCT00040339|"     The purpose of this trial is to determine if hypothermia (body cooling), administered very     soon after a severe brain injury improves functional outcome. This pilot trial ended in July     2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of     the trial (see link below).   "
168986|NCT00040352|"     This study will investigate how genetic and environmental factors contribute to the     development of melanoma, a type of skin cancer, and related conditions.      Individuals of any age with a personal or family history of melanoma may be eligible for this     study. Participants will:        -  Fill out one or two questionnaires about their personal and family medical history.        -  Provide written consent for researchers to review their medical records and pathology          materials related to their care and those of deceased relatives with melanomas, tumors,          cancer, or other related illnesses for whom they are the next-of-kin or legally          authorized representative.        -  Donate a blood or cheek cell sample to be used for genetic studies. (The blood sample is          collected through a needle in an arm vein. The cheek cell sample is obtained either by          gently brushing the inside of the mouth with a soft brush or by swishing a tablespoon of          mouthwash and then spitting it into a container.)        -  Undergo a skin biopsy (removal of a small piece of skin tissue) for genetic study. For          this procedure, the area of skin to be removed is numbed with a local anesthetic and a          1/4-inch piece of skin is excised with a cookie cutter-like instrument. The wound is          then covered with a band-aid.      Participants may be asked to travel to the NIH Clinical Center for evaluation, including a     medical history, physical examination, and some of the following procedures:        -  Full body skin examination to evaluate the type and number of moles and document any          evidence of sun damage to the skin. The examination involves all the skin from the scalp          to the bottoms of the feet. After the examination, a medical photographer will          photograph the skin, with close-ups of skin lesions marked by the examiner. If there are          parts of the skin the participant does not want examined or photographed, he or she can          tell the examiner.        -  Blood draw of about 120 milliliters (4 ounces) or less        -  Skin biopsy        -  Cheek cell sample        -  X-rays, ultrasound and magnetic resonance imaging (MRI) studies to detect tumors or          changes in tumors or other types of changes in specific tissues. MRI is a diagnostic          test that uses strong magnetic fields and radiowaves to examine body tissues. The          subject lies on a table that is moved into a large tunnel-like machine (the scanner) for          about 45 minutes to 1 hour.      When the tests are finished, a doctor will discuss the results with the participant and the     need, if any, for clinical follow-up.   "
169017|NCT00040794|"     This phase II clinical trial studies how well combining different regimens of chemotherapy     and gefitinib with radiation therapy work in treating patients with stage III non-small cell     lung cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Biological therapies     such as gefitinib may interfere with the growth of tumor cells and slow the growth of     non-small cell lung cancer. Radiation therapy uses high-energy x-rays to damage tumor cells.     Giving different regimens of combination therapy together with gefitinib and radiation     therapy may be an effective treatment for non-small cell lung cancer.   "
168987|NCT00040365|"     This study will evaluate the safety and effectiveness of a drug called amifostine in reducing     the bowel side effects of radiation treatment for prostate cancer. Amifostine is a     'radioprotector' medicine that to protects normal tissue from radiation damage. This study     will determine whether placing amifostine in the rectum during radiation treatment for     prostate cancer can decrease common side effects of treatment, including diarrhea, painful     bowel movements, bleeding, and gas.      Patients 18 years of age or older with prostate cancer may be eligible for this study.     Candidates will be screened with a medical history and physical examination, blood tests,     bone scan if a recent one is not available, and possibly computed tomography (CT) and     magnetic resonance imaging (MRI) scans of the pelvis. They will also have a liquid retention     test, in which they are given an enema of 4 tablespoons of salt water that they must retain     for 20 minutes.      Participants will receive standard radiation therapy for prostate cancer-5 consecutive days     for 8 weeks-in the National Institutes of Health (NIH) Radiation Oncology Clinic. Amifostine     will be placed in the rectum by a mini-enema before each radiation treatment so that it     covers the lining of the rectum. To determine the side effects of the treatment, patients     will undergo a proctoscopic examination before beginning radiation therapy, two times during     therapy, and at each follow-up visit for 5 years after treatment ends. This examination     involves inserting a proctoscope (a thin flexible tube with a light at the end) into the     rectum and taking pictures.      Patients will be followed in the clinic at visits scheduled 1, 3, 6, 12, 18, 24, 36, 48, and     60 months after treatment for a physical examination and routine blood tests, proctoscopic     examination, and review of bowel symptoms.   "
168988|NCT00040378|"     The Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE) prevention trial     is an important addition to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). As a     prevention trial, PREADVISE is trying to find out if taking selenium and/or Vitamin E     supplements can help to prevent memory loss and dementia such as Alzheimer's disease.   "
168989|NCT00040391|"     The study will combine a new investigational drug with standard anti-cancer drugs for the     treatment of advanced colorectal cancer. The standard and approved treatment for colorectal     cancer is to undergo chemotherapy with a combination of irinotecan (also known as CPT-11,     Camptosar), 5-fluorouracil (also known as 5-FU), and leucovorin (also known as LV). This is     known as the triple therapy. One of the major side effects of CPT-11/5-FU/LV chemotherapy     treatment is diarrhea. The purpose of this research study is to see whether adding this     investigational drug to the standard treatment for advanced colorectal cancer can reduce the     amount of diarrhea a patient experiences. This study will also determine if adding the     investigational drug to triple therapy has a positive effect on tumors.   "
168990|NCT00040404|"     The purpose of this study is to establish safety for CEP-1347 and to determine an efficacious     dose in the treatment of Parkinson's disease.   "
168991|NCT00040417|"     The major goal of this study is to determine the risks and benefits of stem cell transplants     in combination with a newer, less toxic conditioning chemotherapy treatment in patients with     severe sickle cell disease (SCD) or sickle hemoglobin variants (hemoglobin SC or hemoglobin     SB0/+), or homozygous b0/+ thalassemia or severe B0/+ thalassemia variants. Participation in     this project will be for one year, with follow up evaluations done every 6 months thereafter     for 10 years or until participants are 18 years old.   "
168992|NCT00040430|"     The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when     used with planar and SPECT imaging for the detection of breast cancer.   "
168993|NCT00040443|"     Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild     cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is     evidence CX516 enhances brain activity by specifically targeting remaining glutamate     receptors in the affected portions of the brain. This study will test the safety and efficacy     of CX516 in the symptomatic treatment of participants with mild cognitive impairment.   "
168994|NCT00040456|"     Subjects have a form of sickle cell disease, called hemoglobin SC disease. This results in     abnormally shaped red blood cells that get 'stuck' in blood vessels and then results in     episodes of severe pain (pain crises). Patients with the more common form of sickle cell     disease, called hemoglobin SS disease, also suffer from pain crises. Treatment with the drug     hydroxyurea is available to help prevent the pain crises in hemoglobin SS disease, but there     is no good treatment to help prevent the pain crises in hemoglobin SC disease.      It has been shown that one of the reasons for the formation of the abnormally shaped red     blood cells in patients with SC disease is the fact that these cells do not contain enough     water; they are dehydrated. Drinking more water will not increase the amount of water in the     cells. Certain salts and minerals can however have an effect on the amount of water in the     red blood cells. One of the most important minerals influencing this is called magnesium.     Magnesium is present in food and also in certain medications used to treat heartburn.     Magnesium has been used successfully both in animals and people to increase the amount of     water in the red blood cells and is very well tolerated by most people.      Investigators are using a new form of magnesium known as magnesium pidolate because this form     of magnesium may help with the symptoms of disease without causing diarrhea (a common side     effect of magnesium products).      Purpose The purpose of this study is to find out whether treatment with magnesium pidolate     will increase the amount of water in the red blood cell and result in fewer painful crises in     patients with hemoglobin SC disease while not causing diarrhea.      The study will last for about 64 weeks (about 16 months).   "
168995|NCT00040469|"     The major goal of this study is to determine the risks and benefits of bone marrow     transplants in patients with severe thalassemia or sickle cell disease. Participation in this     project will be for two years.   "
168996|NCT00040482|"     Multiple Sclerosis is a disease that may be caused by the immune system reacting against the     nervous system. It is possible, that by changing the immune system we can modify the     progression of this disease. In this study, we will try to learn whether treatment with a     bone marrow transplant (BMT) can help patients with multiple sclerosis. We will also try to     learn what the side effects are of this treatment in patients with multiple sclerosis.   "
168997|NCT00040495|"     The purpose of this study is to evaluate the efficacy and safety of intravenous pantoprazole     in the prevention of rebleeding in patients with bleeding peptic ulcer disease after     successful endoscopic hemostatic therapy.   "
168998|NCT00040508|"     This study will determine the safety and effectiveness of sirolimus (Rapamune® (Registered     Trademark)) in treating focal segmental glomerulosclerosis (FSGS), a disease involving kidney     scarring and increased protein in the urine. About one-half of patients with FSGS go on to     develop end-stage kidney disease within 6 years, requiring dialysis or kidney transplant.     Therapies to reduce urine protein are likely to stop the progression of renal scarring and     reduce the chance of developing kidney failure. However, current treatments for FSGS, such as     prednisone, cyclophosphamide, and cyclosporine, are not effective in many patients and can     cause serious side effects. This study will see if sirolimus, a drug with both anti-scarring     and immune suppressing properties, can lower the amount of protein in the urine and slow or     stop the kidney disease.      Patients 13 years of age and older with FSGS who have had at least one standard treatment for     FSGS may be eligible for this 24-month study. Pregnant and nursing women may not participate.     Candidates will be screened with a medical history and physical examination, review of     medical records and kidney biopsy, 24-hour urine collection, and blood tests.      Participants will take sirolimus tablets once a day for 1 year. Three 24-hour urine     collections will be done before starting treatment. Blood will be drawn to measure drug     levels every week for the first month after starting treatment, then every other week for 1     month, and then every 2 months until treatment stops. Patients who do not have a complete     response to the drug at low levels will have their dose increased. Patients will be seen at     the NIH clinic in Bethesda, Md., for the screening visit and then at 1, 4, 8, 12, and 15     months for blood and urine tests. Additional urine collections and blood tests will be done     periodically throughout the 24-month study period by the patient's local physician.      Patients whose urine protein decreases on therapy will be asked to wait 3 months before     starting another treatment and will monitored during that time to determine if the response     is sustained. Patients whose urine protein levels do not decrease with sirolimus will not be     asked to wait 3 months before starting another therapy. Follow-up with the local physician     will continue at 18 and 24 months after starting the study.      Patients whose urine protein levels increase with sirolimus treatment will be taken off the     study and may seek other treatment at any time.   "
168999|NCT00040521|"     The purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in     patients with active Crohn's disease (Crohn's Disease Activity Index [CDAI] score from     220-400).   "
169000|NCT00040534|"     The purpose of this study is to determine the safety and tolerability of an oral Farnesyl     Protein Transferase      Inhibitor (SCH 66336) when given in combination with Gemcitabine and Cisplatin in patients     with advanced cancer.   "
169001|NCT00040547|"     The purpose of this study is to determine the safety and tolerability of an oral Farnesyl     Protein Transferase Inhibitor (SCH 66336) when given in combination with intravenous     docetaxel in cancer patients with advanced solid tumors.   "
169002|NCT00040560|"     The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when     used with planar and SPECT imaging for the detection of lung cancer and brain cancer     consistent with metastatic lung cancer.   "
169003|NCT00040573|"     This drug is being developed to treat a type of brain cancer, glioma. This study was designed     to determine a safe and well tolerated dose. Patients must have had prior treatment for their     glioma and be eligible for removal of their recurring tumor.   "
169004|NCT00040586|"     The monoclonal antibody J591 is being investigated as therapy for patients with prostate     cancer, in combination with recombinant interleukin-2 (Proleukin, Aldesleukin). The study is     an open-label, non-randomized phase II study for patients with documented hormone refractory     prostate cancer.   "
169005|NCT00040599|"     The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in     the treatment of colorectal cancer.   "
169006|NCT00040625|"     This study is to evaluate the effects (good and bad) of ALIMTA and Cisplatin or ALIMTA alone     on you and your malignant pleural mesothelioma as well as make ALIMTA available to patients     who qualify for treatment.   "
169007|NCT00040638|"     The purpose of this study is to determine the effectiveness of TLK286 in the treatment of     advanced non-small cell lung cancer.   "
169008|NCT00040651|"     Scleroderma, or systemic sclerosis (SSc), is a diffuse connective tissue disease     characterized by changes in the skin, blood vessels, skeletal muscles, and internal organs.     The purpose of this study is to determine the safety and value of self bone marrow     transplants after chemotherapy in patients with severe SSc.   "
169009|NCT00040664|"     This is a 48-week study to collect additional information on the safety, tolerability,     pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy)     including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old.   "
169010|NCT00040677|"     ICA-17043 is being developed for the chronic treatment of patients with sickle cell disease     (SCD) in both adults and children. ICA-17043 is a potent and specific inhibitor of a channel     in human red blood cells (RBCs) that blocks RBC dehydration. ICA-17043 is expected to inhibit     RBC dehydration and thus should prevent or delay the sickling process. By reducing sickled     cells, an improvement in anemia, a reduction in painful crises, and ultimately, less     end-organ disease is anticipated.   "
169011|NCT00040690|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have Burkitt's lymphoma or Burkitt's leukemia.   "
169012|NCT00040729|"     RATIONALE: Genetic testing for a specific enzyme may help doctors determine whether side     effects from or response to chemotherapy are related to a person's genetic makeup.      PURPOSE: Genetic trial to determine whether different forms of the UGT1A1 gene are related to     the body's ability to break down drugs and to the gastrointestinal side effects seen in     patients previously treated with flavopiridol.   "
169013|NCT00040742|"     RATIONALE: Ginger may help reduce or prevent nausea. It is not yet known if antiemetic drugs     are more effective with or without ginger in treating nausea caused by chemotherapy.      PURPOSE: This randomized phase II/III trial is studying giving antiemetic drugs together with     ginger to see how well they work compared to antiemetic drugs alone in treating nausea in     patients who are receiving chemotherapy for cancer.   "
169014|NCT00040755|"     BMS-275291 may stop the growth of prostate cancer by stopping blood flow to the tumor and by     blocking the enzymes necessary for tumor cell growth. Randomized phase II trial to study the     effectiveness of BMS-275291 in treating patients who have prostate cancer that has not     responded to hormone therapy   "
169015|NCT00040768|"     Phase II trial to study the effectiveness of bortezomib in treating patients who have stage     IIIB, stage IV, or recurrent non-small cell lung cancer. Bortezomib may interfere with the     growth of tumor cells by blocking certain enzymes necessary for tumor cell growth   "
169016|NCT00040781|"     Phase I trial to study the effectiveness of gefitinib in treating children who have     refractory solid tumors. Gefitinib may stop the growth of cancer cells by blocking the     enzymes necessary for tumor cell growth   "
178348|NCT00178087|"     This study will determine the changes in brain structure and function that are responsible     for mood and cognition changes that are sometimes associated with late-life depression.   "
169021|NCT00040846|"     This phase II trial studies the side effects and the best dose of alemtuzumab when given     together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it     works before donor stem cell transplant in treating patients with hematological malignancies.     Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant     helps stop the growth of cancer cells. It may also stop the patient's immune system from     rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find     cancer cells and either kill them or deliver cancer-killing substances to them without     harming normal cells. When the healthy stem cells from a donor are infused into the patient     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,     and platelets. Sometimes the transplanted cells from a donor can also make an immune response     against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF)     after transplant may stop this from happening.   "
169022|NCT00040859|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine     in treating patients who have advanced esophageal cancer or stomach cancer.   "
169023|NCT00040872|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.     Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing     substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to     damage tumor cells. Biological therapies use different ways to stimulate the immune system     and stop cancer cell from growing. Combining different types of therapies may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy, monoclonal     antibody therapy, surgery, peripheral stem cell transplantation, radiation therapy, and     biological therapy in treating patients who have advanced neuroblastoma.   "
169024|NCT00040885|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. Infliximab may improve cancer-related     weight loss, lack of appetite, and fatigue. It is not yet known whether docetaxel is more     effective with or without infliximab in preventing weight loss and fatigue in patients with     advanced cancer. (Infliximab treatment discontinued effective 10/05/05)      PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel with or     without infliximab in preventing weight loss, loss of appetite, and fatigue in patients who     have unresectable non-small cell lung cancer. (Infliximab treatment discontinued effective     10/05/05)   "
169025|NCT00040898|"     RATIONALE: The Chinese herbal medicine Sho-saiko-to contains ingredients that may slow the     growth of tumor cells and stimulate a person's immune system to help kill tumor cells. This     may be an effective treatment following hepatic artery embolization.      PURPOSE: Phase II trial to study the effectiveness of Sho-saiko-to following hepatic artery     embolization in treating patients who have liver cancer.   "
169026|NCT00040911|"     RATIONALE: Electroacupuncture may help to reduce or prevent delayed nausea and vomiting in     patients treated with chemotherapy.      PURPOSE: This randomized clinical trial is studying the effectiveness of electroacupuncture     in treating delayed nausea and vomiting in patients who are receiving chemotherapy for newly     diagnosed childhood sarcoma, neuroblastoma, nasopharyngeal cancer, germ cell tumors, or     Hodgkin lymphoma.   "
169027|NCT00040937|"     RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the     cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.     Giving thalidomide before and after peripheral stem cell transplant may be effective in     treating newly diagnosed multiple myeloma.      PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and     peripheral stem cell transplant work in treating patients with newly diagnosed multiple     myeloma.   "
169028|NCT00040950|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Biological     therapies such as CpG 7909 use different ways to stimulate the immune system and stop cancer     cells from growing. Combining CpG 7909 with rituximab may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of CpG 7909 plus rituximab in treating     patients who have relapsed or refractory non-Hodgkin's lymphoma.   "
169029|NCT00040989|"     RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary     for tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who     have recurrent, unresectable, or metastatic kidney cancer.   "
169030|NCT00041015|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is more effective in treating     extensive-stage small cell lung cancer.      PURPOSE: Randomized phase III trial to compare different chemotherapy regimens in treating     patients who have extensive-stage small cell lung cancer.   "
169031|NCT00041028|"     RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of     anticancer therapy. EF5 is a drug used in the measurement of oxygen in tumor tissue.      PURPOSE: Phase II trial to study the effectiveness of EF5 in assessing tumor response to     anticancer therapy in patients who have stage I, stage II, or stage III non-small cell lung     cancer.   "
169032|NCT00041041|"     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have     persistent or recurrent ovarian epithelial or primary peritoneal cancer. Imatinib mesylate     may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth   "
169033|NCT00041054|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Exisulind may make tumor cells more sensitive to chemotherapy.     Combining chemotherapy with exisulind may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with exisulind     in treating patients who have extensive-stage small cell lung cancer.   "
169038|NCT00041119|"     This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride     compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3     positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to     lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy,     such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways     to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. It is not yet known whether the standard     adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than     paclitaxel in treating women with breast cancer   "
169039|NCT00041132|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells     and either kill them or deliver cancer-killing substances to them without harming normal     cells. Combining rituximab with chemotherapy may kill more cancer cells.      PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with     rituximab in treating patients who have newly diagnosed mantle cell lymphoma.   "
169040|NCT00041171|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. St. John's wort may interfere with the effectiveness of     chemotherapy. It is not yet known if chemotherapy is more effective with or without St.     John's Wort in treating solid tumors.      PURPOSE: Randomized phase III trial to compare the effectiveness of docetaxel with or without     St. John's wort in treating patients who have solid tumors that cannot be removed by surgery.   "
169041|NCT00041197|"     This randomized phase III trial is studying imatinib mesylate to see how well it works     compared to placebo in treating patients with primary gastrointestinal stromal tumor that has     been completely removed by surgery. Imatinib mesylate may interfere with the growth of tumor     cells and may be an effective treatment for patients with primary gastrointestinal stromal     tumor that has been completely removed by surgery.   "
169042|NCT00041210|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known which combination chemotherapy regimen is more effective in treating patients     who have advanced Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination     chemotherapy regimens in treating patients who have advanced Hodgkin's lymphoma.   "
169043|NCT00048906|"     This study will determine the safety of the drug Replagal or treating patients with Fabry     disease, an inherited metabolic disorder. In this disease, an enzyme called     Alpha-galactosidase A, which normally breaks down a fatty substance called     globotriaosylceramide (Gb3), is missing or does not function properly. The resulting     accumulation of Gb3 causes problems with the kidneys, heart, nerves, and blood vessels.     Replagal is a genetically engineered form of Alpha-galactosidase A. Previous studies have     shown that patients with Fabry disease who had not progressed to end-stage kidney failure     tolerated Replagal replacement therapy well. This study will examine the effects of the drug     in patients with kidney problems associated with Fabry disease.      Patients with Fabry disease who are on kidney dialysis, or have had a kidney transplant, may     be eligible for this study.      During this 6 to 12-month study, participants will receive a 40-minute intravenous (IV)     infusion of Replagal every other week, with close monitoring during and after the infusions.     Before the first infusion, patients will be evaluated with a medical history, physical and     neurological examinations, electrocardiogram (ECG), routine blood and urine tests, kidney     test, and measurements of height, weight, and vital signs (blood pressure, pulse, breathing     rate, temperature). In addition, they will have pharmacokinetic studies immediately before     and following the first infusion of Replagal. For these studies, blood samples of less than a     teaspoon each will be drawn to measure the level of Replagal enzyme activity. The samples     will be collected at the following time points: immediately before the infusion; 20 minutes     into the infusion; at the end of the infusion; after the infusion at 50, 60, and 90 minutes,     and 2, 3, 4, and 8 hours.      Safety evaluations will be done once a week for the first month and then once a month for the     rest of the study period. These evaluations include a physical examination, measurement of     vital signs, electrocardiogram, routine blood and urine tests, and kidney testing.   "
169044|NCT00048932|"     The purpose of this clinical research study is to learn if abatacept is safe when     co-administered with other approved rheumatoid arthritis medications.   "
169045|NCT00048945|"     The purpose of this study is to determine the safety and efficacy of Pegasys + placebo +     lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in     patients with hepatitis B antigen CHB.   "
169046|NCT00048958|"     Chromosomal analysis or the study of genetic differences in patients previously untreated     with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It     may also improve the ability to predict the course of disease and the selection of therapy.     Institutions must have either an Alliance-approved cytogeneticist or an agreement from an     Alliance-approved main member cytogenetics laboratory to enroll a patient on CALGB 8461. The     Alliance Approved Institutional Cytogeneticists list is posted on the Alliance for Clinical     Trials in Oncology website.   "
169049|NCT00048997|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known if giving radiation therapy to the head is effective in preventing CNS metastases in     patients who have stage III non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head     works in preventing CNS metastases in patients who have been previously treated for stage III     non-small cell lung cancer.   "
169050|NCT00049010|"     RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node     samples may help doctors identify patients with melanoma who are at risk for developing     metastatic cancer.      PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well     they work in predicting the development of metastatic cancer in patients with stage I or     stage II melanoma.   "
169051|NCT00049023|"     RATIONALE: Radiolabeled octreotide can locate tumor cells and deliver radioactive     tumor-killing substances to them without harming normal cells.      PURPOSE: This phase I trial is to study the safety and effectiveness of radiolabeled     octreotide in treating children who have advanced or refractory solid tumors.   "
169052|NCT00049036|"     This randomized phase II trial is studying how well giving combination chemotherapy together     with rituximab works in treating patients with HIV-associated stage I, stage II, stage III,     or stage IV non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop     cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as     rituximab can locate cancer cells and either kill them or deliver cancer-killing substances     to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy     may kill more cancer cells.   "
180322|NCT00204399|"     The purpose of this study is to systematically test the efficacy of two physician-based     interventions in changing physical activity patterns of adults over a 20-month period.   "
169053|NCT00049062|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight     breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies     such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of     advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in     treating postmenopausal women who have metastatic breast cancer that has not responded to     hormone therapy.   "
169054|NCT00049075|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who     have chronic lymphocytic leukemia that has not been previously treated.   "
169055|NCT00049088|"     Phase I trial to study the effectiveness of combining bortezomib with docetaxel in treating     patients who have advanced solid tumors. Bortezomib may stop the growth of tumor cells by     blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     bortezomib with docetaxel may kill more tumor cells   "
169056|NCT00049101|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the     enzymes necessary for tumor cell growth. Combining erlotinib with combination chemotherapy     may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib with oxaliplatin,     leucovorin, and fluorouracil in treating patients who have metastatic colorectal cancer.   "
169057|NCT00049114|"     Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways     to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth     of tumor cells by blocking the enzymes necessary for their growth. Combining tipifarnib with     doxorubicin and cyclophosphamide may kill more tumor cells. Phase II trial to study the     effectiveness of combining tipifarnib with doxorubicin and cyclophosphamide in treating women     who have locally advanced breast cancer.   "
169058|NCT00049127|"     This phase I/II trial is studying the side effects and best dose of imatinib mesylate and to     see how well it works in treating patients with a recurrent brain tumor that has not     responded to previous surgery and radiation therapy. Imatinib mesylate may stop the growth of     tumor cells by blocking the enzymes necessary for tumor cell growth.   "
169059|NCT00049140|"     RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor     cells may help to plan effective treatment for solid tumors.      PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods     of detecting oxygen levels in tumor cells of patients who have head and neck cancer.   "
169060|NCT00049166|"     Phase I trial to study the effectiveness of combining erlotinib with radiation therapy with     or without cisplatin in treating patients who have advanced mouth or throat cancer. Erlotinib     may stop the growth of tumor cells by blocking the enzymes necessary for their growth.     Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy     use different ways to stop tumor cells from dividing so they stop growing or die. Combining     erlotinib with radiation therapy with or without cisplatin may kill more tumor cells.   "
169061|NCT00049179|"     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.     Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from     dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may     kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with     cytarabine in treating patients who have relapsed acute myeloid leukemia.   "
169062|NCT00049192|"     Phase II trial to study the effectiveness of combining oblimersen with imatinib mesylate in     treating patients who have chronic myelogenous leukemia that has not responded to previous     treatment with imatinib mesylate. Imatinib mesylate may stop the growth of cancer cells by     blocking the enzymes necessary for cancer cell growth. Oblimersen may help imatinib mesylate     kill more cancer cells by making cancer cells more sensitive to the drug.   "
169063|NCT00049218|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Vaccines made from a gene-modified virus may make the body build an     immune response to kill tumor cells. Combining vaccine therapy with chemotherapy may kill     more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by adenovirus     p53 vaccine therapy in treating patients who have extensive-stage small cell lung cancer.   "
169064|NCT00049231|"     RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of     anticancer therapy. EF5 may be effective in measuring oxygen in tumor tissue and helping to     predict the effectiveness of anticancer therapy.      PURPOSE: Diagnostic trial to study the effectiveness of EF5 in detecting tumor hypoxia in     patients who have stage IIB, stage IIIB, or stage IVA cervical cancer.   "
169065|NCT00049244|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with capecitabine     in treating patients who have metastatic breast cancer that has not responded to previous     chemotherapy with a taxane and an anthracycline.   "
169066|NCT00049257|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin     in treating patients who have metastatic prostate cancer that has not responded to hormone     therapy.   "
169067|NCT00049283|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes     necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor     cells. Combining erlotinib with docetaxel may make the tumor cells more sensitive to     radiation therapy and may kill more tumor cells. Phase I trial to study the maximum tolerated     dose (MTD) of combining erlotinib with docetaxel and radiation therapy in treating patients     who have locally advanced head and neck cancer   "
169071|NCT00051051|"     CI-1033 is an experimental drug that acts as an inhibitor of erbB (EGFR) receptors, which may     be involved in tumor growth. The primary objective of this study is to assess the antitumor     activity of CI-1033 in patients with metastatic breast cancer. Patients with histologically     confirmed metastatic (Stage IV) breast cancer and who have received no more than 2 prior     cytotoxic chemotherapy regimens are eligible for this study. CI-1033 is administered orally.     Patients are required to have blood tests periodically while receiving treatment and will be     closely monitored throughout the study for possible side effects and response to treatment.     Patients may not have received any prior treatment with other agents that target erbB     receptors, including Herceptin (trastuzumab) or Iressa (gefitinib).   "
169072|NCT00051077|"     This study will investigate the safety and effectiveness of using adefovir dipivoxil (ADV),     pegylated interferon (PEG-INF), and ribavirin (RBV) in patients triple-infected with     hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV. Patients in this study must be     taking lamivudine (3TC).   "
169073|NCT00051090|"     This study will evaluate the drug telbivudine (LdT) for treatment of hepatitis B virus (HBV)     in HIV infected patients. Patients will take telbivudine alone for 24 weeks, add anti-HIV     drugs for 24 weeks, then stop taking telbivudine while continuing their anti-HIV drug     regimen. To enroll in this study, patients must not be taking any anti-HIV drugs and cannot     have taken more than 31 days of treatment with lamivudine (3TC), protease inhibitors (PIs),     or nonnucleoside reverse transcriptase inhibitors (NNRTIs).   "
169074|NCT00051103|"     The purpose of this study is to determine the efficacy of an oral investigational drug for     the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.   "
169075|NCT00051116|"     To evaluate the response rate, response duration, and survival of patients treated with     CC-5013 in a chronic dosing schedule versus a syncopated dosing schedule.   "
169076|NCT00051129|"     The purpose of this study was to evaluate anecortave acetate compared to placebo for     maintenance of visual acuity after 24 months of treatment in patients with subfovial     choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD).   "
169077|NCT00051142|"     The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost     (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or     ocular hypertension.   "
169078|NCT00051155|"     To compare the safety and IOP-lowering efficacy of TRAVATAN and XALCOM in subjects with     open-angle glaucoma or ocular hypertension.   "
169079|NCT00051168|"     Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular     hypertension.   "
169080|NCT00051181|"     To demonstrate that the intraocular pressure(IOP)-lowering efficacy of Travoprost (0.004%) is     equal or better than that of Latanoprost 0.005% in patients with chronic angle-closure     glaucoma.   "
169081|NCT00051194|"     To compare the intraocular pressure(IOP)-lowering efficacy of morning or evening     instillations of a combination IOP-lowering therapy in patients with open-angle glaucoma or     ocular hypertension.   "
169082|NCT00051207|"     This 6-month study, with a 3-month follow up period, will compare the effectiveness of new     and traditional psychotherapies for depression with panic or anxiety symptoms.   "
169083|NCT00051220|"     This study will compare the effectiveness of three treatments in reducing symptoms of phobia     in children and adolescents.   "
169084|NCT00051233|"     The purpose of this study is to assess the effectiveness of a Web-based psychoeducational     program in helping people with schizophrenia and their families manage the disease.   "
169085|NCT00051246|"     This study will compare standard individual treatment to group therapy for the treatment of     postpartum depression.   "
169086|NCT00051259|"     The purpose of this trial is to study the effects of two depression medications on sexual     functioning.   "
169087|NCT00051272|"     This study will evaluate the effects of two antidepression medications on sexual functioning.   "
169092|NCT00051337|"     This study will use single photon emission computed tomography (SPECT) to determine what     areas of the brain are responsible for paroxysmal hyperkinetic movement disorders. Patients     with these disorders have sudden, brief attacks of movement, similar to epileptic seizures,     but without loss of consciousness. SPECT is a nuclear medicine test that produces     three-dimensional images of the brain, showing blood flow and function in different brain     regions. This test, which can detect the focus of epileptic seizures, will be used in this     study to scan patients while they are experiencing a hyperkinetic movement attack, while they     are not having and attack, and while they are simulating an attack.      Patients 18 years of age and older who have paroxysmal movement attacks that can be easily     induced by a specific trigger, such as a sudden movement or prolonged exercise, may be     eligible for this study. Candidates will be screened with a medical history and review of     their medical records, physical examination, videotape of attacks, and, for women, a     pregnancy test.      Participants will have three SPECT scans, separated from each other by at least 48 hours.     Before each scan, the subject will perform an activity that ordinarily precipitates a     movement attack, such as standing up from a chair, assuming a certain posture, or doing     something strenuous. Each scan will try to record one of the following conditions:        -  The subject performs the trigger activity, but does not have an attack;        -  The subject performs the trigger activity and has an involuntary attack as a result;        -  The subject performs the trigger activity and does not have an attack, but then mimics          an attack voluntarily.      After the condition is recorded, the subject will be given an injection of a radioactive     agent called 99m Technetium and will then relax quietly for 40 to 60 minutes before the SPECT     scan. For the scan, the subject lies on an examination table and the SPECT camera is moved     near and around the head to image the brain. The scan takes about 40 minutes.      Participants will also undergo one magnetic resonance imaging (MRI) scan. For this test, the     subject lies in a narrow cylinder (the scanner), while pictures of the brain are taken.     Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency     circuits used in the scanning process. The procedure takes about 30 minutes.   "
169093|NCT00051350|"     To compare the effects on blood pressure and plasma lipids of three different diets--a     carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.   "
169094|NCT00051363|"     The purpose of this study is to determine the effectiveness of nasal continuous positive     airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea syndrome (OSAS).   "
169095|NCT00051376|"     The body produces a natural compound, nitric oxide (NO), which is known to improve the     elasticity of blood vessels effect cardiac function and play a role in the remodeling process     after a heart attack. The primary source of NO is one of the amino acids that the body uses     to form new proteins, L-Arginine; although many individuals with heart disease also take     medicines to increase the concentrations of NO such as nitroglycerine. The VINTAGE-MI trial     is intended to investigate wether supplementation of the bodies supply of NO with oral     administration of L-Arginine will improve the functional recovery of older patients who have     recently suffered their first heart attack.   "
169097|NCT00051402|"     The purpose of this study is to investigate whether soy-derived phytoestrogens taken as     dietary supplements improve memory function in postmenopausal women who have experienced     early memory decline.   "
169098|NCT00051415|"     Flaxseed, a rich source of fiber, may be a significant component of a cholesterol-reducing     diet. The purpose of this study is to evaluate the safety and effectiveness of flaxseed in     reducing high cholesterol.   "
169099|NCT00051428|"     The purpose of this study is to investigate the effectiveness of Reiki in the treatment of     fibromyalgia (FM), a condition characterized by widespread muscle pain and stiffness, often     accompanied by sleep disturbance, headaches, irritable bowel syndrome, and psychological     distress. Reiki is a form of energy medicine in which practitioners reportedly access     universal life energy to heal patients, either by direct contact at specific hand positions     or from a distance.   "
169100|NCT00051441|"     The purpose of this study is to compare the effectiveness and safety of benzydamine     hydrochloride 0.15% oral rinse to a vehicle oral rinse in the treatment of radiation-induced     oral mucositis, and to compare the care normally used for radiation-induced oral mucositis to     vehicle oral rinse to ensure that the vehicle does not have detrimental effects on the oral     mucosa   "
169101|NCT00051454|"     This study will examine the safety and immune response to a two-part HIV vaccine. Healthy     volunteers who are at low risk of HIV infection will receive either active vaccine or a     placebo.   "
169102|NCT00051467|"     The primary purpose of this study is to assess the safety and effectiveness of TNFerade™     Biologic when administered concurrently with 5-FU and radiation therapy as first-line     treatment of unresectable locally advanced pancreatic cancer.      TNFerade™ is a replication deficient adenovirus vector containing the gene for TNF-alpha     controlled by a chemoradiation inducible promoter. This allows the expression of TNF-alpha to     be greatest in the area receiving radiation. TNF-alpha is a cytokine that has been shown to     have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at     effective doses. TNFerade™ Biologic is a novel way of selective delivery of TNF-alpha to     tumor cells.      TNFerade™ Biologic will be injected during five weekly injection sessions, concomitant with     radiation and 5-FU. TNFerade™ Biologic will be administered by direct intratumoral injection     using a percutaneous approach (PTA) or endoscopic ultrasound (EUS).   "
169103|NCT00051480|"     The primary purpose of this study is to assess the safety and feasibility of giving TNFerade™     with 5-FU, Cisplatin and radiation therapy to patients with locally advanced, esophageal     cancer prior to surgical resection. TNFerade™ is a replication deficient (E1, E3 and E4     deleted) adenovirus vector containing the gene for TNF-alpha controlled by a radiation     inducible promoter. This allows the expression of TNF-alpha to be greatest in the area     receiving radiation. TNF-alpha is a potent cytokine that has been shown to have potent     anti-cancer activities but, due to systemic toxicity, could not be delivered at effective     doses. TNFerade™ is a novel way of selective delivery of TNF-alpha to tumor cells.      TNFerade™ will be delivered once a week for five weeks by direct intratumoral injection by     using endoscopy or Endoscopic Ultrasound. 5-FU (1000 mg/m2/day) will be delivered via     continuous infusion for 96 hours during weeks 1 and 4. Cisplatin (75 mg/m2) will be delivered     on Day 1 and Day 29 intravenously. The dose of radiation delivered will be 45 Gy in 1.8 Gy     fractions for 5 weeks.   "
169104|NCT00051493|"     The purpose of this study is to evaluate the effects (good and bad) of LY231514 (ALIMTA) and     Carboplatin on you and your non-small cell lung cancer.   "
169105|NCT00051506|"     The purpose of this study is to evaluate the effects (good and bad) of ALIMTA plus     Carboplatin or ALIMTA plus Cisplatin on you and your small cell lung cancer.   "
169122|NCT00051753|"     The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with     amoxicillin/clavulanate on the clinical response at the end of therapy in infants and     children who have recurrent and/or persistent acute otitis media.   "
169106|NCT00051519|"     This screening study will evaluate potential study volunteers with HIV infection to see if     they are suitable candidates for trials of experimental vaccines against HIV (therapeutic),     and against other infections (preventive).        -  Preventive vaccines against other infections. Preventive vaccines prevent a person from          getting a disease. Preventive vaccines have been developed for many diseases, including,          for example, whooping cough, measles, mumps, influenza, and hepatitis B. Some preventive          vaccines may also prevent a disease from taking hold if given immediately after          infection, such as vaccines for rabies, smallpox and hepatitis.        -  Therapeutic vaccines against HIV. Therapeutic vaccines are intended to treat someone who          has already been infected, with the goal of controlling the disease or preventing it          from causing severe illness. As yet, there are no therapeutic vaccines for any diseases.        -  Vaccines against other infections. Vaccines to prevent other infections besides HIV may          need to be tested separately in people with HIV infection because the immune system          works differently when HIV infection is present.      HIV-infected patients 18 years of age or older may be eligible for this screening study.     Women who are pregnant or breast feeding may not participate.      Participants will be screened with the following:        -  A health history, including questions about sexual activity and drug use;        -  Physical examination, including blood and urine tests;        -  HIV testing to confirm HIV infection;        -  Pregnancy test for premenopausal women;        -  PPD test for tuberculosis for those who have not been tested in the previous 6 months.      Candidates who meet the requirements for investigational vaccine studies will be invited to     participate in a study. Those who do not begin a study within 1 month of the screening tests     may need to repeat some tests for continued consideration. In addition, some studies require     repeated measures of CD4 counts and viral load over a period of a few months.   "
169107|NCT00051532|"     The purpose of the study is to determine whether seocalcitol is effective in the treatment of     advanced primary liver cancer (hepatocellular carcinoma [HCC]).   "
169108|NCT00051545|"     To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended     curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol     injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation     therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma (HCC).   "
169109|NCT00051558|"     Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and     there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed     to treat a large number of conditions such as arthritis and asthma. When taken for several     months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis     called glucocorticoid-induced osteoporosis. This study compared the effects of     teriparatide, the study drug, with alendronate, an approved drug for treating     glucocorticoid-induced osteoporosis.   "
169150|NCT00052117|"     This is a 48 week study for HIV-infected patients who have failed several regimens including     PI's, NNRTs and NRTIs. Patients will be randomly selected to be in 1 of 4 groups. Three of     the 4 groups will contain capravirine in different doses combined with Kaletra and     nucleosides and one of the groups will be a combination of Kaletra and nucleosides without     the capravirine.   "
169110|NCT00051571|"     This randomized phase II clinical trial evaluates the combination of a monoclonal     antibody-based drug (SGN-15) with a chemotherapeutic agent compared to chemotherapy given     alone in patients with non-small cell lung cancer that has failed at least one prior systemic     therapy. The objective of the study is to determine the safety and clinical benefit, as     measured by tumor response and quality of life, to the combination regimen.      Monoclonal antibody therapy has been used in other types of cancer to target therapy to the     tumor, thereby allowing for the chemotherapeutic agent to have a lesser effect on normal,     healthy tissue.   "
169111|NCT00051584|"     This is an open-label, randomized phase II trial comparing treatment with a monoclonal     antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly     Gemzar® (Gemcitabine) to treatment with Gemzar® alone. The primary objectives of this study     are to determine the toxicity and safety profile of the combination of SGN-15 and Gemzar®, to     estimate the clinical response rate and to estimate the duration of response of this     combination therapy administered to patients with advanced ovarian cancer, compared to     treatment with Gemzar® alone.   "
169112|NCT00051597|"     The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric     monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic     malignancies.      This is a single-arm, open-label phase I/II study designed to define the toxicity profile,     pharmacokinetic (PK) profile, and anti-tumor activity of a multi-dose regimen of SGN-30 in     patients with refractory or recurrent CD30+ hematologic malignancies. The phase I study will     be a modified dose escalation of SGN-30. Based on preclinical pharmacology and toxicokinetics     (TK) and the first use in human single-dose phase I study, SGN-30 will be administered on a     weekly schedule. An initial dose of 2 mg/kg will escalate until the maximum tolerated dose     (MTD) has been reached or until a weekly dose of 12 mg/kg is achieved.   "
169113|NCT00051623|"     The purpose of this study is to determine if Infliximab is safe and effective in the     treatment of psoriatic arthritis. Infliximab (Remicade) targets specific proteins in the     body's immune system to help control the development of inflammation to help reduce painful     disease.   "
169114|NCT00051636|"     The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.)     infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone.     The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The     extended observation period included participants of the core study who responded to     treatment.   "
169115|NCT00051662|"     The purpose of this study is to determine whether a humanized monoclonal antibody     (efalizumab) is safe and effective in the treatment of psoriatic arthritis (PsA)   "
169116|NCT00051675|"     The purpose of this study is to evaluate the safety, immunogenicity, and tolerability of a     monoclonal antibody administered subcutaneously in the treatment of advanced cancers of the     ovary, breast, lung, prostate, colon or rectum that are either refractory to standard     therapies or for which therapies that may potentially be of major benefit do not exist.   "
169117|NCT00051688|"     The primary purpose of this study is to determine the best dose of tezacitabine when combined     with oxaliplatin in patients with metastatic colorectal cancer. This study will also evaluate     tumor response to the combination of anti-cancer drugs.   "
169118|NCT00051701|"     The purpose of this study is to determine the optimal dose of Campath for patients with     relapsing or refractory (failed standard therapy) non-Hodgkin's lymphoma. The study will also     evaluate the safety of the drug and whether it is effective in treating these patients.   "
169119|NCT00051714|"     The purpose of this study is to examine the immediate and long-term effects of a prevention     program in children at risk for developing conduct problems and antisocial behavior.   "
169120|NCT00051727|"     The purpose of this study is to test the efficacy of a family-based psychosocial intervention     to prevent school disengagement and reduce the incidence of depression, conduct disorders,     and school dropout for Mexican American adolescents.   "
169121|NCT00051740|"     This study will compare Cognitive Adaptation Training (CAT) to minimal schizophrenia     treatment. This study will also determine whether the intensity of CAT can be reduced and     still provide benefits to patients with schizophrenia.   "
169124|NCT00051779|"     This study is intended to evaluate the safety, tolerability, and possible effectiveness of an     investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related     protein (PTHrP) when compared to zoledronic acid in patients with breast cancer metastatic to     bone.      The study will also evaluate the possible effects of both study drugs on performance status,     markers of bone metabolism, and skeletal events related to bone metastasis including elevated     blood calcium levels, bone pain, metastatic lesions, complications and interventions. The     levels of CAL in the blood will also be evaluated.   "
169125|NCT00051792|"     The purpose of this study is to evaluate the safety and effectiveness of yoga in reducing     shortness of breath in people with chronic obstructive pulmonary disease (COPD). Patients in     this study must have moderate to severe COPD and be primarily limited by shortness of breath.   "
169126|NCT00051805|"     One of the main causes of treatment failure in HIV infected individuals is lack of adherence     to complicated drug regimens. The purpose of this study is to evaluate the effectiveness of a     behavioral intervention program designed to improve adherence to anti-HIV drug regimens.     Participants in this study will be recruited from the University of Alabama at Birmingham     (UAB) Outpatient HIV Clinic.   "
169127|NCT00051818|"     The purpose of this study is to determine if stopping anti-HIV drugs for a period of time is     safe and effective for enhancing the immune function of patients with HIV.   "
169128|NCT00051831|"     HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy     the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called     a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced     treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.   "
169129|NCT00051844|"     This is a 48 week study that is intended for HIV Infected persons whose first treatment     regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now     failing that regimen. They must be currently on their failing regimen to be eligible.   "
180396|NCT00186238|"     To assess the role of autologous hematopoietic cell rescue in the treatment of multiple     myeloma.   "
169130|NCT00051857|"     This study will use magnetic resonance imaging (MRI) and ultrasound images to study how     muscles, tendons, and bones work together to cause motion. The procedure is one of several     tools being developed to characterize normal and impaired musculoskeletal function, with the     goal of developing improved methods of diagnosis and treatment of movement disorders.      Healthy normal volunteers must be age 5 to unlimited, with or without joint impairment, may     be eligible for this study. Volunteers with joint impairment may not have serious injury to     the joint being studied, previous surgery on the joint being studied, or extreme pain at the     joint being studied.      MRI uses a strong magnet and radio waves to create images of the inside of the body. The     subject lies on a long narrow couch inside a metal cylinder (the scanner) for up to 3 hours     while the scanner gathers data. Earplugs are worn to muffle loud noises caused by electrical     switching of radiofrequency circuits used in the scanning process. A special pad or tube may     be placed over or around the region being scanned to improve the quality of the data. The     subject will be asked to repeatedly move a specific joint, such as the knee, for brief     periods, usually less than 5 minutes. The subject can communicate via intercom with the     person performing the study at all times during the procedure, and may request to stop the     study at any time.   "
169131|NCT00051870|"     This two-part study will use transcranial magnetic stimulation, or TMS (see below), to     explore how the brain forms memories. People remember only some of the events they experience     every day, such as faces they perceive, words they read, speech they hear and interpret, and     so forth. The events remembered are those that have been saved or formed in the brain. Part 1     of this study involves testing materials for Part 2, the TMS experiment. Part 2 uses TMS to     examine what parts of the brain are involved in forming memories. Information gained from     this study may be used in developing methods of enhancing memory in both healthy people and     in patients with memory impairments.      Healthy right-handed volunteers between 18 and 35 years of age may be eligible for this     study. Candidates may be screened with a medical interview and physical examination and a     brief test of short- and long-term visual and verbal memory. Eligible volunteers may     participate in Part 1 or Part 2 of the study, as follows:      Part 1 - Preparation of Words and Picture Materials      Participants look at several words or shapes that appear in random order on a computer screen     and try to remember them as well as possible for a memory test that will be given 20 minutes     later. Each image appears on the screen for 3/4 of a second, with 1-1/4-second intervals     between them. For the test, words and shapes are again shown on the computer screen at the     same timing and intervals. When the items appear, the subject presses one of three buttons as     quickly as possible, determining if he or she has recognized the items with a high or low     level of confidence. The entire procedure lasts up to 1 hour, with breaks in between. The     purpose of this experiment is to find appropriate words and pictures to use as stimuli in the     TMS study described below.      Part 2 - TMS Experiment      For TMS, the subject sits in a comfortable chair. An insulated wire coil is placed on the     scalp, and brief electrical currents are passed through the coil, creating magnetic pulses     that stimulate the brain. The pulses may cause a pulling sensation on the skin under the coil     and twitching in muscles of the arm or leg. Electrodes are taped to the skin over some     muscles of the hands to record the electrical activity of the muscles. Pulses are delivered     in trains or short bursts of impulses, each lasting half a second. Participants receive 90     trains for a total of 900 pulses. TMS is applied during the first part of the memory study,     when the words and shapes are first presented on the computer screen, but not during the     second presentation for memory testing. The entire procedure takes up to 2 hours, with breaks     in between.      Before the TMS session, participants undergo magnetic resonance imaging (MRI) to determine     where to place the coil for TMS. For MRI, the subject lies still for up to 30 minutes at a     time on a table that slides into the scanner, a narrow metal cylinder surrounded by a strong     magnetic field. Earplugs are worn to muffle loud knocking sounds that occur while the scanner     takes pictures. Subjects can communicate with the MRI staff at all times and can ask to stop     the procedure at any time.   "
169132|NCT00051883|"     The purpose of this study is to asses patient views on smoking cessation and tobacco harm     reduction during drug treatment.   "
169133|NCT00051896|"     The purpose of this study is to assess the potential interactions between iv cocaine and GBR     12909.   "
169134|NCT00051909|"     Study of an investigational medication for the treatment of Alzheimer's Disease in patients     who are not taking Aricept, Reminyl, Exelon.   "
169135|NCT00051922|"     The purpose of the study is to determine the safety of a new HIV vaccine and to evaluate the     immune response to the vaccine. Only some HIV genes are used to make the vaccine and     therefore the vaccine cannot itself cause HIV or AIDS.   "
169136|NCT00051935|"     GSD-II (also known as Pompe disease) is caused by a deficiency of a critical enzyme in the     body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break     down glycogen (a stored form of sugar) within specialized structures called lysosomes. In     patients with GSD-II, an excessive amount of glycogen accumulates and is stored in various     tissues, especially heart and skeletal muscle, which prevents their normal function. This     study is being conducted to evaluate the safety, pharmacokinetics, pharmacodynamics and     efficacy of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme     replacement therapy for a pair of siblings with GSD-II. To be eligible for this study, a     patient must have a confirmed diagnosis of GSD-II and have a sister or brother who also has a     confirmed diagnosis of GSD-II.   "
169137|NCT00051948|"     This is a dose-ranging, open label, Phase 1-2a study of TLK286 in combination with Paraplatin     (carboplatin) in patients with recurrent ovarian cancer.   "
169138|NCT00051961|"     This study will examine the effects of the drug Ropinirole on spinal cord reflexes and on     symptoms of restless legs syndrome (RLS). Patients with RLS have uncomfortable sensations in     the legs, usually in the evening or early part of the night. Most patients also have periodic     involuntary leg movements. The condition tends to worsen over time, resulting in severe     discomfort and sleep disturbances. Ropinirole affects chemical messengers thought to be     involved in spinal cord function and in modulating RLS symptoms.      Healthy normal volunteers and patients with RLS between 18 and 80 years of age may be     eligible for this study. Patients must have mild to moderate RLS and periodic limb movements.     All candidates will be screened with a medical history, physical and neurological     evaluations, electromyogram (see below), polysomnogram (see below), electrocardiogram (ECG),     and blood and urine tests. They may also have magnetic resonance imaging (MRI) or     computerized tomography (CT) scans and a chest x-ray. Participants must stop taking all     medications prohibited by the study for at least 1 week before the study starts and     throughout its duration.      The study will last approximately 2 to 3 weeks for healthy volunteers and 7 to 8 weeks for     patients. Participants will undergo the following baseline evaluations:     electroencephalography (EEG), a measure of brain wave activity; polysomnography (PSG), an     overnight sleep study; electromyography (EMG), a measure of muscle activity; and spinal     flexor reflex studies (spinal cord responses to electrical stimulation). For these studies,     several electrodes are attached to the scalp or to the legs and arms using a cream that helps     conduct brain signals through the cables to be recorded. The nervous system activity can be     assessed at rest or after stimulation with an electric current. For EMG, a small needle is     inserted into a few muscles and the subject is asked to relax or to contract the muscles. The     electrical activity of the muscle cells is recorded and analyzed by a computer. Spinal flexor     reflex studies usually involve stimulating the nerves in the legs with very brief electric     currents of mild to moderate intensity. Flexor reflex studies will be done early in the night     while the subject is awake and also during sleep. Brain, muscle and breathing activities will     be monitored continuously during sleep.      A suggested immobilization test (SIT) will be done around 10 p.m. During the test, the     subject sits still for about 1 hour, while the leg muscle activity is recorded using special     electronic devices attached to the skin. At the end of the test, volunteers will be asked     questions about symptoms they may have experienced during the test, and patients will be     asked questions about their RLS symptoms during the test.      After the baseline tests, participants will be randomly assigned to take either Ropinirole     tablets or a placebo (a look-alike inactive substance) daily for 5 weeks. They will be     admitted to the NIH Clinical Center for 3 to 4 nights at the end of the second week and for 2     nights at the end of the study to repeat the baseline tests described above. Volunteers will     take Ropinirole or placebo daily for 1 week. They will be admitted to the Clinical Center for     3 to 4 days at the beginning and then at the end of the study for repeat testing.      Medical examinations, ECGs and blood tests will be done at various times during the study for     safety monitoring. Patients' blood pressure will be monitored weekly. Small amounts of blood     will be drawn up to three times each day for routine studies, research and drug levels.     Throughout the study volunteers will complete questionnaires for evaluation of possible RLS     symptoms, and patients will have their symptoms assessed using a RLS Severity Rating Scale.     Two weeks after the study ends, participants will be interviewed by telephone about any     adverse experiences.   "
169139|NCT00051974|"     The purpose of this study is to evaluate how tumors in patients with non-small cell lung     cancer respond to treatment with VELCADE alone versus VELCADE given with docetaxel and also     to see what effects (good and bad) it has on you and your cancer.   "
169140|NCT00051987|"     The purpose of this study is to evaluate how tumors in patients with colorectal carcinoma     respond to treatment with VELCADE alone versus VELCADE given with irinotecan, and also to see     what effects (good and bad) it has on you and your cancer.   "
169141|NCT00052000|"     This is the first study of MLN2704 administered to humans. The purpose of the study is to     determine the highest dose of MLN2704 that can be given safely to patients with prostate     cancer, and to identify any side effects associated with taking the drug. This study will     also evaluate how MLN2704 is taken up (absorbed), broken down (metabolized) and eliminated     (excreted) by the body. This process is called pharmacokinetic analysis.   "
169142|NCT00052013|"     The purpose of this study is to determine whether PTK787/ZK 222584 is effective in treating     hemangioblastoma of the brain and/or retina in patients with von Hippel-Lindau disease. The     study will also assess safety and tolerability of PTK787/ZK 222584, and changes in markers of     angiogenesis (new blood vessel growth).   "
173536|NCT00115323|"     This is a randomized, controlled study that will compare two medication adherence strategies     in adults with moderate or severe persistent asthma as a method for improving or maintaining     treatment adherence.   "
169143|NCT00052026|"     The purpose of this study is to determine whether a new medicine, called carvedilol, improves     symptoms and heart function in children who have congestive heart failure (diminished     function of their heart muscle that pumps blood to the body). To accomplish this, we will     give carvedilol to some patients who have diminished heart function and congestive heart     failure and see whether symptoms and heart function are better at the end of an 8 month     period in those who received carvedilol compared to the other patients who did not receive     carvedilol. We will be testing 2 different doses of carvedilol compared to no additional     medicine.   "
169144|NCT00052039|"     Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b     in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210     patients.   "
169145|NCT00052052|"     Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250     patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety     and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up     to 48 weeks.   "
169146|NCT00052065|"     This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in     patients with platinum refractory or resistant ovarian cancer.   "
169147|NCT00052078|"     This randomized, controlled trial compared the efficacy of the medication sertraline     (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for     youth with anxiety disorders.   "
169148|NCT00052091|"     This study will compare the effectiveness of Problem Solving Therapy and Brief Supportive     Therapy in treating elderly patients with major depression and thought problems.   "
169149|NCT00052104|"     The purpose of this study is to develop an effective, low-cost, telephone-based intervention     to reduce anxiety, depression, and feelings of burden and stress in caregivers of patients     with dementia. This study will also determine whether the intervention can alter the course     of dementia.   "
169151|NCT00052130|"     This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage     III), and who have had all of their cancer surgically removed. The purpose of this study is     to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of     melanoma.   "
169152|NCT00052143|"     The purpose of this study is to define the natural history and experiences of people who are     at risk for developing Huntington's disease but who do not know their genetic status.   "
169153|NCT00052156|"     This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or     a distant organ, and who have had all of their cancer surgically removed. The purpose of this     study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence     of melanoma.   "
169154|NCT00052169|"     The purpose of this study is to learn how breast cancer tumors respond to treatment combining     the drugs docetaxel and ZD1839.   "
169155|NCT00052182|"     HIV-1-infected patients who have been treated with anti-HIV drugs for a long time may have     weakened immune responses to HIV. The DNA-based vaccine in this study is designed to boost     the immune system's responses against many HIV-1 proteins. The main purposes of this study     are to test the safety of this HIV vaccine (EP HIV-1090) and to test whether the vaccine can     stimulate immune system responses in people who have HIV-1 infection.   "
169156|NCT00052195|"     A significant number of HIV infected patients in Africa also have disseminated tuberculosis     (infection throughout multiple organs). This type of tuberculosis is a significant cause of     mortality in these patients. The purpose of this study is to evaluate the safety and     effectiveness of a vaccine designed to prevent disseminated tuberculosis.   "
169157|NCT00052208|"     This phase I/II trial studies the side effects and best dose of gefitinib when given together     with radiation therapy and to see how well it works in treating patients with glioblastoma     multiforme. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving     gefitinib together with radiation therapy may be an effective treatment for glioblastoma     multiforme.   "
169158|NCT00052221|"     RATIONALE: Epoetin alfa may help improve energy levels and quality of life in patients who     have advanced solid tumors.      PURPOSE: Randomized clinical trial to study the effectiveness of epoetin alfa in treating     fatigue in patients who are not receiving chemotherapy for advanced solid tumors.   "
169159|NCT00052273|"     RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for     cancer cell growth and by stopping blood flow to the tumor. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     LY317615 with capecitabine may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining LY317615 with capecitabine in     treating patients who have advanced solid tumors.   "
169160|NCT00052286|"     RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes     such as memory loss in patients who have undergone treatment for primary brain cancer. The     effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet     known.      PURPOSE: This randomized clinical trial is comparing how well two different doses of     modafinil work in treating fatigue and behavioral changes in patients who have undergone     treatment for primary brain cancer.   "
169161|NCT00052299|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. It is not yet     known if combining combination chemotherapy with monoclonal antibody therapy will kill more     cancer cells.      PURPOSE: Randomized phase III trial to determine the effectiveness of combination     chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute     myeloid leukemia.   "
169221|NCT00053326|"     This phase II trial is studying how well fenretinide works in treating children with     recurrent or resistant neuroblastoma. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die.   "
169162|NCT00052312|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.     It is not yet known whether doxorubicin and cisplatin are more effective with or without     paclitaxel in treating endometrial cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and     cisplatin with or without paclitaxel in treating patients who have locally advanced,     metastatic, and/or relapsed endometrial cancer.   "
169163|NCT00052325|"     RATIONALE: Mistletoe may help the body build an immune response and may improve quality of     life to help patients live more comfortably.      PURPOSE: This phase II trial is studying mistletoe to see how well it works in treating     patients who are receiving palliative chemotherapy for stage IIIB or stage IV non-small cell     lung cancer.   "
169164|NCT00052338|"     Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer     cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing     so they stop growing or die. Combining more than one chemotherapy drug and bortezomib may     kill more tumor cells   "
169165|NCT00052351|"     RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune     response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase     the number of immune cells found in bone marrow or peripheral blood. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining vaccine therapy with sargramostim and chemotherapy may kill more tumor cells.      PURPOSE: Randomized clinical trial to study the effectiveness of vaccine therapy plus     sargramostim and combination chemotherapy in treating women who have undergone surgery for     stage II or stage III breast cancer that has spread to the lymph nodes.   "
169166|NCT00052364|"     Phase II trial to study the effectiveness of oxaliplatin in treating patients who have     unresectable, recurrent or metastatic liver cancer. Drugs used in chemotherapy use different     ways to stop tumor cells from dividing so they stop growing or die.   "
169257|NCT00053846|"     RATIONALE: Buspirone may be effective in reducing dyspnea (shortness of breath) in patients     with cancer who are undergoing chemotherapy.      PURPOSE: Randomized clinical trial to study the effectiveness of buspirone in reducing     shortness of breath in patients who are undergoing chemotherapy for cancer.   "
169167|NCT00052377|"     Phase I/II trial to study the effectiveness of combining interleukin-12 with interleukin-2 in     treating patients who have mycosis fungoides. Biological therapies, such as interleukin-12     and interleukin-2, use different ways to stimulate the immune system and stop cancer cells     from growing. Combining more than one biological therapy may kill more tumor cells   "
169168|NCT00052390|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Bevacizumab may stop the growth of tumor cells by stopping blood     flow to the tumor. Combining doxorubicin with bevacizumab may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin with bevacizumab     in treating patients who have locally recurrent or metastatic soft tissue sarcoma.   "
169169|NCT00052403|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have advanced solid tumors.   "
169170|NCT00052416|"     RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.      PURPOSE: Phase I trial to determine the effectiveness of thalidomide in treating patients who     have asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.   "
169171|NCT00052429|"     RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may     kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     high-dose radiation with chemotherapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy     with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage     IV nasopharyngeal cancer.   "
169172|NCT00052442|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in     treating patients who have recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's     lymphoma.   "
169173|NCT00052455|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which regimen of chemotherapy is more effective in treating recurrent malignant     glioma.      PURPOSE: Randomized phase III trial to compare the effectiveness of temozolomide alone to     that of procarbazine, lomustine, and vincristine in treating patients who have recurrent     malignant glioma.   "
169174|NCT00052468|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than     carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.      PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with     gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating     patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.   "
169175|NCT00052481|"     RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may     help determine the intermediate-term and long-term effects of surgery and brachytherapy.      PURPOSE: Randomized clinical trial to study quality of life in patients undergoing radical     prostatectomy or brachytherapy for stage II prostate cancer.   "
169176|NCT00052494|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by     blocking the enzymes necessary for their growth. Combining more than one chemotherapy drug     with imatinib mesylate may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining cisplatin, irinotecan, and     imatinib mesylate in treating patients who have extensive-stage small cell lung cancer.   "
169177|NCT00052507|"     RATIONALE: Bortezomib may interfere with the growth of tumor cells by blocking the enzymes     necessary for cancer cell growth.      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who     have metastatic or recurrent colorectal cancer.   "
169178|NCT00052520|"     This phase I/II trial is studying the side effects of biological therapy and to see how well     it works in treating patients with advanced myelodysplastic syndrome, chronic myeloid     leukemia, acute myeloid leukemia, or acute lymphoblastic leukemia. Biological therapies,     including immunotherapy, can potentially be used to stimulate the immune system and stop     cancer cells from growing. Immunotherapy given to patients who have undergone donor stem cell     transplantation may be a way to eradicate remaining cancer cells   "
169179|NCT00052559|"     This phase I trial is studying the side effects and best dose of bevacizumab when given     together with fluorouracil and external-beam radiation therapy in treating patients with     stage II or stage III rectal cancer. Monoclonal antibodies, such as bevacizumab, can block     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.     Others find cancer cells and help kill them or deliver cancer-killing substances to them.     Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they     stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining monoclonal antibody therapy with chemotherapy and radiation therapy may kill more     tumor cells.   "
169180|NCT00052572|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who     have relapsed or refractory lymphoproliferative disorders.   "
169181|NCT00052585|"     Phase II trial to study the effectiveness of combining gefitinib with fluorouracil,     leucovorin, and irinotecan in treating patients who have advanced or recurrent colorectal     cancer. Biological therapies such as gefitinib may stop the growth of tumor cells by blocking     the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to     stop tumor cells from dividing so they stop growing or die. Combining gefitinib with     fluorouracil, leucovorin, and irinotecan may kill more tumor cells   "
169366|NCT00045864|"     The purpose of this study is to determine the safety and effectiveness of combination therapy     with Proleukin and Rituxan on patients with intermediate-and high- grade Non-Hodgkin's     lymphoma.   "
169182|NCT00052598|"     This phase I/II trial is studies the side effects of giving therapeutic allogeneic     lymphocytes together with aldesleukin and to see how well it works in treating patients with     high-risk or recurrent myeloid leukemia after undergoing donor stem cell transplant.     Biological therapies, such as therapeutic autologous lymphocytes, may stimulate the immune     system in different ways and stop cancer cells from growing. Aldesleukin may stimulate the     white blood cells to kill cancer cells. Giving therapeutic autologous lymphocytes together     with aldesleukin may kill more cancer cells   "
169183|NCT00052611|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Celecoxib may be effective in preventing head and neck     cancer in patients who have oral leukoplakia or head and neck dysplasia.      PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing cancer in     patients who have oral leukoplakia and/or head and neck dysplasia.   "
169184|NCT00052624|"     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.     Immunotoxin therapy may be an effective treatment for glioblastoma multiforme and anaplastic     astrocytoma.      PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy in treating children     who have progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma   "
169185|NCT00052637|"     RATIONALE: Diagnostic procedures such as cystoscopy may improve the ability to detect cancer     and to determine the extent of disease.      PURPOSE: Diagnostic trial to compare the effectiveness of cystoscopy using hexyl     5-aminolevulinate and two light sources in detecting carcinoma in situ in patients who have     bladder cancer.   "
169186|NCT00052676|"     RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue     dye near the tumor is more effective than injecting them near the nipple in identifying     sentinel lymph nodes in patients with stage I or stage II breast cancer.      PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc     99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in     detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.   "
169187|NCT00052689|"     Randomized phase II trial to compare the effectiveness of bortezomib with or without     gemcitabine in treating patients who have metastatic pancreatic cancer. Bortezomib may stop     the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used     in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining bortezomib with gemcitabine may kill more tumor cells.   "
169188|NCT00052715|"     RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune     system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage     tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation     therapy in treating patients who have newly diagnosed glioblastoma multiforme.   "
169189|NCT00052728|"     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary     for tumor cell growth. Tamoxifen may fight breast cancer by blocking the use of estrogen.     Combining tipifarnib with tamoxifen may be effective treatment for metastatic breast cancer.      PURPOSE: This phase II trial is studying how well giving tipifarnib together with tamoxifen     works in treating women with metastatic breast cancer.   "
169190|NCT00052754|"     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor     cells and slow the growth of synovial sarcoma.      PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have     locally advanced or metastatic synovial sarcoma.   "
169191|NCT00052780|"     Phase I trial to study the safety of combining O6-benzylguanine with temozolomide in treating     children who have recurrent or refractory brain tumors. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die.     O6-benzylguanine may increase the effectiveness of temozolomide by making tumor cells more     sensitive to the drug.   "
169192|NCT00052832|"     RATIONALE: Doxercalciferol may improve low blood cell counts and decrease the need for blood     transfusions and may be an effective treatment for myelodysplastic syndrome or chronic     myelomonocytic leukemia.      PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients     who have myelodysplastic syndrome or chronic myelomonocytic leukemia.   "
169193|NCT00052845|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Estramustine may     fight prostate cancer by reducing the production of androgens. Exisulind may stop the growth     of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining these     therapies may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining estramustine with exisulind     and docetaxel in treating patients who have metastatic prostate cancer that has not responded     to hormone therapy.   "
169194|NCT00052884|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma     cells, either by killing the cells or by stopping them from dividing. Having a peripheral     stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows     higher dose of chemotherapy to be given so that more plasma cells are killed. Giving a     chemoprotective drug such as amifostine may protect kidney cells from the side effects of     chemotherapy.      PURPOSE: This phase I trial is studying the side effects and best dose of melphalan given     together with amifostine in treating patients who are undergoing peripheral stem cell     transplant for primary systemic amyloidosis.   "
169195|NCT00052897|"     Phase I/II trial to study the effectiveness of SGN-00101 in preventing anal cancer in     HIV-positive patients who have high-grade anal neoplasia. Chemoprevention therapy is the use     of certain drugs to try to prevent the development of cancer. SGN-00101 may be effective in     preventing anal cancer.   "
169196|NCT00052910|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor     cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen     is more effective in treating stomach or esophageal cancer.      PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation     therapy regimens in treating patients who have undergone surgery for stomach or esophageal     cancer.   "
169197|NCT00052923|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Combining chemotherapy with stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.     Monoclonal antibodies, such as rituximab, can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. It is not yet known     whether stem cell transplantation is more effective with or without rituximab in treating     relapsed or progressive B-cell diffuse large cell lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of stem cell transplantation     with or without rituximab in treating patients who have relapsed or progressive B-cell     diffuse large cell lymphoma.   "
169198|NCT00052936|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. It is not yet known whether combination chemotherapy is more effective with or without     rituximab in treating aggressive non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying how well giving cyclophosphamide,     doxorubicin, vincristine, and prednisone together with or without rituximab works in treating     older patients who have aggressive non-Hodgkin's lymphoma. (This trial is no longer     randomized as of 6/2005).   "
169199|NCT00052949|"     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have     recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by     blocking the enzymes necessary for cancer cell growth.   "
169200|NCT00052962|"     This study will determine which of the two following treatment regimens provides greater     benefit to patients with peritoneal carcinomatosis (gastrointestinal cancer that has spread     throughout the abdomen):        -  Surgical removal of tumors plus heated chemotherapy during surgery, followed by one dose          of chemotherapy 7 to 12 days after surgery, followed 3 weeks later by 4 months of          chemotherapy; or        -  Surgical removal of tumors followed by 4 months of chemotherapy, starting 1 month after          surgery.      Patients 18 years of age and older with peritoneal carcinomatosis may be eligible for this     study. Candidates are screened with a medical history, physical examination, and blood tests;     chest X-ray and computed tomography (CT) scans; review of pathology slides; electrocardiogram     (EKG), bone scan, and brain magnetic resonance imaging (MRI), as needed; and laparotomy.     Laparatomy is a surgical procedure in which an incision is made in the abdomen to look at the     amount and location of tumors in the abdominal cavity. Patients whose surgery reveals that     the tumors cannot be removed are taken off study. Those eligible for the study have their     tumors removed during this screening laparotomy as part of the study procedure, as follows:      All participants undergo laparotomy and removal of as much tumor as possible, as described     above. Patients are then randomly assigned to one of two treatment groups:        -  Group 1 - During laparotomy, after tumor removal, patients receive continuous          hyperthermic peritoneal perfusion (CHPP) with the anti-cancer drug cisplatin. For CHPP,          the cisplatin solution is heated and delivered to the abdomen through a catheter          (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the          body through another catheter. At the close of surgery, a small catheter, called a          Tenckhoff catheter, is left in the abdomen and brought out through the skin. Between          days 7 and 12 after surgery, one dose of fluorouracil and paclitaxel chemotherapy is          delivered through this catheter. The catheter is removed following complete recovery          from surgery and the patient is discharged from the hospital. Four to 6 weeks after the          surgery, patients have CT scans of the chest, pelvis, and abdomen, and then begin          intravenous (IV, through a vein) chemotherapy with oxaliplatin, 5-fluorouracil (5-FU),          and leucovorin. The chemotherapy is given in 4-week courses as follows: oxaliplatin on          day 1, infused over 2 hours through a vein in the arm or neck; leucovorin on days 1 and          2, infused over 2 hours, followed by 5-fluorouracil over 22 hours; leucovorin and 5-FU          repeated two weeks later on days 15 and 16. This regimen is repeated two weeks later.          Between each week of chemotherapy is a week break. A course of chemotherapy consists of          28 days (two weeks of chemotherapy and two 1-week breaks). Patients may receive up to          four courses (total of 16 weeks) unless their disease progresses or they cannot tolerate          further doses. Doses of the chemotherapy can be reduced if the side effects are too          severe.        -  Group 2 - Patients follow the same procedure as those in Group 1 for laparotomy, CT          imaging, and IV chemotherapy with oxaliplatin, 5-fluorouracil, and leucovorin. They do          not receive CHPP or chemotherapy into the abdomen.      All patients undergo repeat imaging tests six weeks after surgery and at the conclusion of     the intravenous (IV) chemotherapy. They return for a physical examination and CT scans every     three months for the first year, every four months for the next two years, and then every six     months for up to five years after treatment. They are also asked to complete quality of life     questionnaires before and after surgery, at the completion of chemotherapy, and at every     follow-up visit.   "
169201|NCT00053001|"     RATIONALE: Thalidomide may stop or slow the growth of cancer cells. Epoetin alfa may     stimulate red blood cell production. Combining thalidomide with epoetin alfa may improve     anemia, decrease the need for blood transfusions, and improve the quality of life in patients     with myelodysplastic syndrome.      PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with epoetin alfa     in treating anemia in patients who have myelodysplastic syndrome.   "
169202|NCT00053014|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an     immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may     prevent this from happening.      PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation     followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate     mofetil in treating older patients who have acute myeloid leukemia.   "
169203|NCT00053027|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy such as cladribine work in different ways to stop cancer cells from dividing so     they stop growing or die. Combining rituximab with cladribine may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with cladribine     works in treating patients with newly-diagnosed mantle cell lymphoma.   "
169204|NCT00053040|"     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of immunotoxin     therapy and to see how well it works in treating children undergoing surgery for recurrent or     progressive malignant glioma.   "
169205|NCT00053053|"     RATIONALE: Nutritional supplements may help prevent loss of appetite, weight loss, and     fatigue in patients with advanced cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two nutritional     supplements in preventing loss of appetite, weight loss, and fatigue in patients who have     stage III or stage IV solid tumors.   "
169206|NCT00053092|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells     and either kill them or deliver cancer-killing substances to them without harming normal     cells. It is not yet known if combination chemotherapy is more effective with or without     rituximab in treating mantle cell lymphoma.      PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and     cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in     treating patients who have mantle cell lymphoma.   "
169207|NCT00053105|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effect of combination chemotherapy on the body when     treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.   "
169208|NCT00053118|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with peripheral     stem cell transplantation in treating children who have central nervous system cancer.   "
169209|NCT00053131|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Colony-stimulating factors such as filgrastim and sargramostim     may increase the number of immune cells found in bone marrow or peripheral blood and may help     a person's immune system recover from the side effects of chemotherapy. It is not yet known     whether combination chemotherapy is more effective followed by filgrastim or sargramostim in     treating leukemia.      PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy     followed by filgrastim with that of combination chemotherapy followed by sargramostim in     treating patients who have relapsed or refractory acute myeloid leukemia or acute     lymphoblastic leukemia.   "
169210|NCT00053144|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with cytarabine in     treating patients who have refractory or recurrent acute myeloid leukemia or chronic     myelogenous leukemia.   "
169367|NCT00045877|"     The purpose of this study is to determine the safety and effectiveness of combination therapy     with Proleukin and Rituxan on patients with low-grade Non-Hodgkin's Lymphoma who have     previously failed Rituxan treatments.   "
169211|NCT00053157|"     RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune     cells found in bone marrow or peripheral blood and may help a person's immune system recover     from the side effects of chemotherapy or radiation therapy. Giving sargramostim to the stem     cell donor and the patient may reduce the chance of developing graft-versus-host disease     following stem cell transplantation.      PURPOSE: Clinical trial to study the effectiveness of sargramostim in decreasing     graft-versus-host disease in patients who are undergoing donor stem cell transplantation for     hematologic cancer or aplastic anemia.   "
169212|NCT00053183|"     RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor     to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor     cells. Combining internal radiation with external-beam radiation therapy may kill any     remaining tumor cells following surgery.      PURPOSE: Phase I trial to study the effectiveness of combining internal radiation therapy     with external-beam radiation therapy in treating patients who have undergone surgery for     glioblastoma multiforme.   "
169213|NCT00053196|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor     bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells.     It also stops the patient's immune system from rejecting the donor's stem cells. The donated     stem cells may replace the patient's immune system and help destroy any remaining cancer     cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor     lymphocyte infusion) after the transplant may help increase this effect. Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving immunosuppressive therapy after the transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell     transplant works in treating patients with relapsed hematologic cancer after treatment with     chemotherapy and autologous stem cell transplant.   "
169214|NCT00053209|"     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes     necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Combining     pemetrexed disodium with gemcitabine may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with     gemcitabine in treating patients who have advanced cancer of the urothelium.   "
169215|NCT00053222|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients     who have locally advanced or metastatic pancreatic cancer that has not responded to     gemcitabine.   "
169216|NCT00053235|"     This research trial studies tissue samples from patients with ovarian cancer in the     laboratory. Analyzing tissue samples from patients in the laboratory may help doctors learn     more about cancer.   "
169217|NCT00053248|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by     blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib     mesylate may kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with     imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia.   "
169218|NCT00053261|"     RATIONALE: Vaginal changes that may effect sexual function occur in patients undergoing     treatment for cervical cancer.      PURPOSE: Clinical trial to determine the type of vaginal changes such as vaginal dryness that     occur in patients receiving treatment for cervical cancer and the effect these changes have     on sexual function.   "
169219|NCT00053287|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping     blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining fludarabine, carboplatin, and     topotecan with thalidomide in treating patients who have relapsed or refractory acute myeloid     leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes.   "
169220|NCT00053300|"     RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.      PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who     have extensive-stage small cell lung cancer that has responded to previous chemotherapy.   "
169222|NCT00053339|"     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Estrogen can     stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast     cancer by blocking the uptake of estrogen. Combining trastuzumab with tamoxifen may kill more     tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of trastuzumab with or     without trastuzumab in treating women who have invasive stage IV breast cancer.   "
169223|NCT00053352|"     This phase III trial is studying surgery followed by combination chemotherapy to see how well     it works in treating children with germ cell tumors that are not located in the head. Drugs     used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining more than one drug, and giving them after surgery, may kill any     remaining tumor cells following surgery. It is not yet known whether combination chemotherapy     is effective in decreasing the recurrence of childhood germ cell tumors.   "
169224|NCT00053365|"     Phase II trial to study the effectiveness of irofulven in treating patients who have     recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die.   "
169225|NCT00053378|"     A study to determine the effect of Zemplar on the regulation of serum calcium levels and the     need for administration of elemental calcium in hypocalcemic intensive care patients   "
169226|NCT00053391|"     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make     the body build an immune response to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients     who have stage III or stage IV melanoma.   "
169368|NCT00045903|"     This study will evaluate the effectiveness of two cognitive behavioral therapies (CBTs) in     treating obsessive compulsive disorder (OCD) in patients who are taking medication but still     have residual symptoms.   "
169227|NCT00053404|"     Drug resistant HIV strains often develop in patients who have taken anti-HIV drugs for an     extended time. However, these drug resistant HIV strains do not always cause an increase in     the level of HIV in the blood. This study will explore why some patients with drug resistant     virus continue to have low viral loads.   "
169228|NCT00053417|"     Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central     Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal     cord, providing communication between the brain and the arms and legs. In people with MS, the     fatty sheath that surrounds and insulates the nerve fibers (called myelin) deteriorates,     causing nerve impulses to be slowed or stopped. As a result patients with MS may experience     periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of     coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the     ability to think and/or remember. These periods of illness may come (exacerbations) and go     (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases     the ability of the nerve to conduct electrical impulses. This study will evaluate the effects     of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the     effects on muscle strength and spasticity. The study will also examine the possible risks of     taking Fampridine-SR.   "
169229|NCT00053430|"     Despite treatment with anti-HIV drugs, people infected with HIV continue to have problems     with their immune systems. This study will evaluate whether the drug thalidomide, which     stimulates the immune system's T cells, can improve immune system function in people with     HIV.   "
169230|NCT00053443|"     While anti-HIV drugs can significantly reduce viral loads, the medication regimens can be     complex, and patients must take them correctly for the best effect. Nonadherent patients risk     developing drug resistant HIV strains. The purpose of this study is to evaluate the     effectiveness of a handheld computerized system designed to help patients take their drugs     correctly.   "
169231|NCT00053456|"     This study will look at the effect of a cardiac rehabilitation exercise program on release of     stem cells from the bone marrow and on heart function. Stem cells are primitive cells     produced and released by the bone marrow, circulate in the bloodstream and develop into white     blood cells, red blood cells and platelets. Some stem cells may also develop into other kinds     of cells, including those that make up heart muscle, especially if the heart has been damaged     or is not getting sufficient blood. Stem cells called endothelial progenitor cells (EPCs) are     thought to form new blood vessels that can carry blood to areas of the heart muscle that are     oxygen-deprived because of clogged arteries. Previous experiments have shown that some EPCs     can be forced out of the bone marrow by exercise. This study will examine whether repeated     exercise and lifestyle changes increase the number of EPCs released into the bloodstream and     if these cells improve heart and blood vessel function.      Patients 21 years of age and older with coronary artery disease may be eligible for this     study. Candidates will be screened with a medical history and physical examination, including     a cardiovascular evaluation, and blood tests. The participants will be enrolled in a 2- to     3-month cardiac rehabilitation program that includes 24 to 36 60-minute sessions of exercise,     plus instruction on lifestyle changes related to diet, stress management, and relaxation     techniques. In addition, participants will undergo the following tests and procedures:        -  Brachial reactivity study: This test measures how well the arteries widen. The patients          rest for 30 minutes, and then an ultrasound device is placed over the artery just above          the elbow. The device measures the size of the artery and blood flow through it before          and after the patient is given a spray of nitroglycerin under the tongue.        -  Blood tests for EPC levels and genetic testing: These measure EPCs and determine whether          certain genes that may regulate EPC function are turned on or off. Genes are made up of          DNA, the molecules that lead to the production of proteins by cells. Some of these          proteins may be important in releasing EPCs from the bone marrow to travel in the          bloodstream to the heart and repair blood vessels and muscle cells.        -  Treadmill exercise testing: Patients exercise on a treadmill with continuous monitoring          of the heartbeat and frequent measurements of oxygen saturation, using a finger clip          device. The patient continues to exercise until moderate chest pain, shortness of          breath, or fatigue develops.        -  Questionnaire: Patients fill out a 15-minute questionnaire about their general physical          and mental health status at the first and last visits to the clinic.        -  Magnetic resonance imaging (MRI) of the heart: Patients who are eligible to undergo MRI          have this test twice during the study, once before beginning the rehabilitation program          and again after completing the program. The MRI shows heart function and blood flow in          the heart. For this test, the patient lies on a stretcher inside a long narrow cylinder          (the scanner). During the scan, the drug dipyridamole, which increases blood flow to the          heart, is infused into a vein of the hand or arm. Another drug, gadolinium, is also          infused to brighten the images produced.   "
169232|NCT00053469|"     This study will explore how babies become able to use their experience with objects to plan     to manipulate them appropriately. For example, an adult knows that picking up a grocery bag     full of canned food requires different actions than are needed for lifting an empty bag. This     study will examine when and how infants first begin to adapt their actions to manipulate     specific objects that weigh different amounts.      Participants will include normal healthy babies within 2 weeks of their first birthday. If     the expected results are obtained from testing, 9-month-old children will then be studied to     identify a lower age boundary in task performance. If the expected results are not obtained     at the 12-month test age, older children will be recruited to participate.      The study involves one 30-minute session with the baby and his or her mother or father. The     parent will answer some questions about the family, such as its size and ethnic make-up. The     infant will then have small magnetic sensors taped to the underside of each arm and to the     back. While sitting on the parent s lap, the infant will be presented with plastic toys, and     his or her actions will be measured by the sensors as he or she reaches for and picks up the     toys. The sensors will be connected to a computer that will track and record the motion of     the infant s arms.   "
169233|NCT00053482|"     The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a     cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age     and previously vaccinated against smallpox.   "
169234|NCT00053495|"     The purpose of this study is to examine the safety and the effectiveness of a new vaccine for     the prevention of the disease, smallpox.   "
169235|NCT00053508|"     The purpose of this study is to examine the safety and the effectiveness of a new vaccine for     the prevention of the disease, smallpox.   "
169236|NCT00053521|"     To determine the role of genetic factors influencing risk factors for cardiovascular disease,     ultimately identifying specific genes influencing the age-related progression of     cardiovascular disease risks.   "
169237|NCT00053534|"     To monitor trends in congestive heart failure in Olmsted County, Minnesota.   "
169238|NCT00053547|"     The purpose of this study is to see if Zemplar, a vitamin D medication, safely and     effectively decreases parathyroid hormone in children ages 2-20 with End Stage Renal Disease.   "
169239|NCT00053560|"     The purpose of this clinical trial is to study the effects of GL701 on bone mineral density     in women with active systemic lupus erythematosus (SLE) who are also receiving treatment with     glucocorticoids (e.g., prednisone).   "
169240|NCT00053573|"     Glycogen Storage Disease Type II (GSD-II; also known as Pompe disease) is caused by a     deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally,     GAA is used by the body's cells to break down glycogen (a stored form of sugar) within     specialized structures called lysosomes. In patients with GSD-II, an excessive amount of     glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle,     which prevents their normal function. This study is being conducted to evaluate the safety     and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme     replacement therapy for GSD-II. Patients diagnosed with infantile-onset GSD-II who are     greater than 6 months old, but less than or equal to 36 months old will be studied.   "
169241|NCT00053599|"     CLASP is a research study to investigate the safety and effectiveness of simvastatin (a     cholesterol lowering drug or statin) to slow the progression of Alzheimer's disease (AD).     Statins are commonly used to treat high cholesterol levels, which increase the risk of heart     disease and stroke.   "
169242|NCT00053612|"     HIV infected individuals with vitamin A deficiency may be more likely to transmit the virus     to others than HIV infected individuals who have normal levels of vitamin A. The presence of     HIV DNA in vaginal secretions may indicate a greater risk for transmission of HIV to others.     The purpose of this study is to determine if taking vitamin A decreases the level of HIV DNA     in vaginal secretions.   "
169243|NCT00053625|"     The purpose of this trial is to evaluate the effect of deep brain stimulation in the the     globus pallidus (Gpi) and the subthalamic nucleus (STN) on motor, neuropsychological and     psychiatric function, and quality of life in patients with Parkinson's disease.   "
169369|NCT00045916|"     This study will evaluate the effectiveness of electroconvulsive therapy (ECT) administered     with medication for the treatment of a major depressive episode (unipolar or bipolar) and     will compare two types of ECT.   "
169244|NCT00053638|"     This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation     containing two FDA-approved drugs in HIV-infected patients who have not received prior     therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily     regimen. Study physicians will evaluate subjects to determine if they have certain medical     conditions, laboratory test values, medication use, or drug allergies that would exclude them     from the study.   "
169245|NCT00053651|"     This study will determine whether a prevention program reduces the incidence of postpartum     depression in pregnant women who receive public assistance and are at risk for postpartum     depression.   "
169246|NCT00053677|"     This study will establish the best dose of the drug naltrexone to treat patients with     Pathological Gambling Disorder (PGD) and severe urge symptoms.   "
169247|NCT00053690|"     The purpose of this study is to develop an effective treatment for people with Post Traumatic     Stress Disorder (PTSD) along with other mental illnesses.   "
169248|NCT00053703|"     This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine     (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with     schizophrenia or schizoaffective disorder.   "
169249|NCT00053716|"     This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a     vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure     to treat or open up a blocked artery within one lower limb or the most affected of two limbs     in subjects with Peripheral Arterial Occlusive Disease.   "
169250|NCT00053742|"     This study will test the safety of an experimental vaccine called modified vaccinia virus     ankara (MVA) and determine if it confers protection against the smallpox virus (variola).     There is an existing vaccine, called Dryvax® (Registered Trademark), which is effective     against smallpox; however, this vaccine can cause various side effects, including some that,     on rare occasions, can be life-threatening. Dryvax® (Registered Trademark) has not been used     in the United States since childhood vaccination was stopped in 1971, and though it is given     to certain healthcare and laboratory workers, and some people in the armed forces, it is not     recommended for the general population. Both the MVA and Dryvax® (Registered Trademark)     vaccines are made using the vaccinia virus, which is closely related to variola.      Healthy normal volunteers between 31 and 60 years of age who have been vaccinated with a     smallpox vaccine more than 10 years before entering the study may be eligible for this     protocol. Candidates will be screened with a medical history, physical examination, and blood     and urine tests, including an HIV test and a pregnancy test for women of childbearing     potential.      Participants will receive MVA vaccine or placebo, followed by a dose of Dryvax® (Registered     Trademark). The MVA vaccine and placebo are injected into an arm muscle with a needle and     syringe. The Dryvax® (Registered Trademark) vaccine is administered with a special forked     needle that is poked lightly into the skin of the upper arm, usually 15 times, in a process     called scarification. When the vaccine works, a small pus-filled blister forms, followed by a     scab and then scarring at the site of the vaccination. The formation of the blister and scab     is called a take, indicating that the vaccine is effective and will protect against smallpox     for at least a few years. If scarification does not take, it can either mean that the person     already has immunity or that the vaccine did not work.      Study participants will be randomly assigned to one of the following dosing groups: 1) one     injection of MVA; 2) one injection of placebo; 3) two injections of MVA 4 weeks apart; or 4)     two injections of placebo 4 weeks apart. All participants will receive a challenge dose of     Dryvax® (Registered Trademark) 12 weeks after their last injection of MVA or placebo to     determine if the MVA vaccine has conferred immunity. A take, that occurs in response to the     Dryvax® (Registered Trademark) dose indicates lack of prior immunity, and thus tells whether     one or two doses of MVA is needed to produce an immune response.      Participants will be observed for at least 1 hour after each injection. They will come to the     clinic at least once a week after MVA or placebo injections and at least twice a week after     Dryvax® (Registered Trademark) to have the injection site evaluated and photographed. At each     visit, participants will be asked how they are feeling and what medications, if any, they are     taking. Blood and urine tests will be done according to the following schedule:        -  Before each injection;        -  1 week after each injection;        -  4 weeks after the MVA or placebo injections are finished;        -  At the time of the Dryvax® (Registered Trademark) dose;        -  4 weeks after the Dryvax® (Registered Trademark) dose;        -  12 weeks after the Dryvax® (Registered Trademark) dose.      Additional laboratory tests may be done between visits if medically necessary.   "
169251|NCT00053768|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug and giving the drugs in different     ways may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer     cells. It is not yet known which combination chemotherapy regimen followed by radiation     therapy is more effective in treating aggressive non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens     followed by radiation therapy to compare how well they work in treating patients with     aggressive non-Hodgkin's lymphoma.   "
169252|NCT00053781|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who     have metastatic or recurrent malignant melanoma.   "
169253|NCT00053794|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who     have metastatic or locally advanced soft tissue sarcoma.   "
169263|NCT00044278|"     This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with     partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age     who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will     be added to the subject's current epilepsy medications.   "
169254|NCT00053807|"     RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may     stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     interferon alfa and interleukin-2 with fluorouracil may kill any remaining tumor cells     following surgery. It is not yet known whether combining interferon alfa and interleukin-2     with fluorouracil is more effective than observation after surgery for kidney cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combining interleukin-2,     interferon alfa, and fluorouracil to that of observation alone in treating patients who have     undergone surgery for kidney cancer and are at high risk of relapse.   "
169255|NCT00053820|"     RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may     stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     interferon alfa with interleukin-2 and fluorouracil may kill more tumor cells. It is not yet     known whether interferon alfa is more effective with or without interleukin-2 and     fluorouracil in treating metastatic kidney cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa combined     with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who     have advanced metastatic kidney cancer.   "
169256|NCT00053833|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who     have refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer.   "
169258|NCT00053872|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Giving radiation therapy in different ways with combination chemotherapy may kill any     remaining tumor cells following surgery. It is not yet known which radiation therapy regimen     combined with combination chemotherapy is more effective in treating medulloblastoma.      PURPOSE: Randomized phase III trial to compare different radiation therapy regimens plus     combination chemotherapy in treating children who have undergone surgery for medulloblastoma.   "
169259|NCT00044226|"     Patients who are currently symptomatic and have been diagnosed with BPH by a physician may     qualify for this 20-week study. Patients must not be diabetic, must not have prostate cancer     and must not have had any surgery to repair your prostate or treat your BPH. Patients will     first undergo a phone screening to confirm their eligibility and interest and to rule out any     exclusionary history or medications. Eligible patients will be scheduled to come in to the     clinic to sign an Informed Consent Form. Patients will then undergo blood and urine tests, a     complete physical examination and history and answer several questionnaires to determine     their eligibility. Patients will have a total of at least 7-8 visits over 20 weeks to the     clinic during this study.Qualified patients receive free study medication, free medical care     (physical examinations, EKG, laboratory tests) for the duration of the study.   "
169260|NCT00044239|"     The purpose of this study is to learn more about Obsessive-compulsive Disorder (OCD) in     children. OCD usually has a slow onset, and symptoms that may remain at a stable level over     time. A subset of children with OCD has a sudden onset and symptoms that fluctuate in     severity over time. This study will also compare healthy children to those with OCD. This is     an observational study; children who participate will not receive any new or experimental     therapies.      OCD affects nearly 1% of the pediatric population. The symptoms of this illness can interrupt     development, causing significant psychological distress and producing life-long impairments     in social, academic, and occupational functioning. A subgroup of pediatric OCD has been     designated by the acronym PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated     with Streptococcal Infections). This type of OCD is characterized by sudden symptom onset and     a relapsing-remitting course of illness; exacerbation of symptoms occurs with scarlet fever     or strep. throat infections. This study will identify factors that distinguish children with     PANDAS OCD from children with non-PANDAS OCD, and will compare both groups to healthy     children.      Children with OCD and their parents are screened with interviews and a review of the child's     medical records. Participants have an initial evaluation that includes a psychiatric,     physical and neuromotor exam, neuropsychological testing, psychological interviews, and a     blood test. Structural magnetic resonance imaging (MRS) scans of the brain are also obtained.     The MRS scan does not use radiation.      After the initial evaluation, children with OCD have follow-up visits every 6 weeks for 12 to     24 months. They are seen yearly for 8 years after the study. If they have a significant     improvement or worsening of their symptoms, they are asked to make a maximum of two extra     visits. Parents of OCD patients are called four times a year to discuss any changes in the     child's condition between yearly visits. All participants have a 1-year follow-up visit upon     study completion.   "
169261|NCT00044252|"     This study will measure and compare hormone levels in women with catamenial epilepsy     (epilepsy in which seizures are more frequent during menstrual periods), women with seizures     not related to their menstrual cycle, and normal control subjects. It will determine whether     there are differences among the three groups in their hormone levels or in how fast the     levels change. It will also examine what relationship, if any, exists between hormone changes     and seizures in women with catamenial epilepsy. The hormones under study include the gonadal     hormones estrone, estradiol and progesterone, and the neuroactive steroids allopregnanolone,     pregnenolone, and dehydroepiandrosterone.      Women who meet the following criteria may be eligible for this 3-month study:        -  Between 18 and 45 years of age, with catamenial epilepsy        -  Between 18 and 45 years of age, with seizures, but not catamenial epilepsy        -  Between 18 and 45 years of age, without seizures      All participants will have a physical examination at the beginning of the study, at each     clinic visit, and at completion or withdrawal from the study. In addition, they will undergo     the following procedures:      Baseline Monitoring      For the first 2 months, all participants will keep a diary of their temperature and onset of     menses. Women with epilepsy will also record their seizures.      Electroencephalography (EEG)      Healthy volunteers will have a 45-minute EEG (recording of the electrical activity of the     brain) at the beginning of each menstrual cycle and each day during the menses. Women with     epilepsy will have continuous EEG monitoring for 8 days, beginning 5 days before their     menstrual period is expected. The continuous monitoring can be done on an outpatient basis,     using a portable EEG recording device, or as an inpatient, with admission to the hospital for     the 8 days of recording.      Blood Sampling      All participants will have a small blood sample (2 teaspoons) drawn once a day on days 10,     14, 17, 19 and 21 of their menstrual cycle and three times a day on day 6 and for a period of     8 days, starting 5 days before the expected menses and continuing for 3 days of the next     cycle. For the days with three blood draws, a small needle that can stay in place for up to     72 hours will be placed in the arm to avoid the discomfort of multiple needle sticks.   "
169262|NCT00044265|"     Ramipril is an ACE inhibitor that has been marketed in the US for the treatment of     hypertension since 1991. It has been shown to be effective in reducing both systolic and     diastolic blood pressure in adults when used once daily. ACE inhibitors are frequently used     to treat hypertension in children, however ramipril has not been extensively tested in     children, and information regarding the efficacy and safety would therefore be of benefit to     children. This study is designed to demonstrate the efficacy and safety of ramipril in the     treatment of hypertension in children ages 6 through 16 years.   "
169264|NCT00044291|"     The purpose of this study is to determine whether the first line combination hormonal therapy     of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is     more effective than another approved drug, letrozole (Femara®), in delaying the growth of     breast cancer in postmenopausal patients with locally advanced or metastatic breast cancer,     and whether the side effects of the combination are different from the side effects of     letrozole.   "
169265|NCT00044304|"     The purpose of this study is to evaluate the safety and efficacy of the tyrosine kinase     inhibitor, imatinib mesylate (Gleevec ) in reducing peripheral blood eosinophilia in patients     with the myeloid form of hypereosinophilic syndrome (HES). Patients with the     hypereosinophilic syndrome who meet a set of criteria designed to select patients with the     myeloid form of the disease, as well as patients without myeloid disease who are refractory     to standard therapy for HES, will be admitted on this protocol. A thorough clinical     evaluation will be performed with emphasis on potential sequelae of eosinophil-mediated     tissue damage. A baseline bone marrow will be obtained to exclude leukemia or lymphoma and to     assess the degree and nature of eosinophilopoiesis. Bone marrow, blood cells and/or serum     will also be collected to test for the presence of a recently described mutation that is     associated with imatinib-responsiveness in HES, and to provide reagents (such as DNA, RNA,     and specific antibodies) and for use in the laboratory to address issues related to the     mechanism of action of imatinib mesylate in HES. Imatinib mesylate will be initiated at a     dose of 400 mg daily, the FDA-approved dose for the treatment of chronic myelogenous     leukemia. In patients who demonstrate a complete clinical and hematologic response to     imatinib therapy and who do not have life-threatening disease, the dose will be decreased     gradually to 100mg daily and then discontinued. In order to minimize bone marrow suppression,     other myelosuppressive agents will be tapered and discontinued during the first week of     therapy with imatinib mesylate. Complete blood counts will be performed weekly for the first     month and biweekly thereafter. Clinical assessments will be performed every three months to     assess progression of end organ damage.      In patients who demonstrate a complete clinical and hematologic response to imatinib therapy     and who do not have life-threatening disease, the dose will be decreased gradually to 100 mg     daily and then discontinued. In the event of clinical, hematologic or molecular relapse     during the taper, the imatinib dose will be increased to a maximum of 600 mg daily to achieve     a second remission. Laboratory monitoring will be performed as above except for molecular     monitoring which will be monitored monthly if drug is discontinued or molecular relapse     occurs. Once a stable dosing regimen is achieved for greater than or equal to 6 months in     subjects who have undergone dose descalation or greater than or equal to 2 years in subjects     receiving 300-400 mg of imatinib daily who did not qualify for dose de-escalation, the     frequency of NIH visits and end organ assessments will be decreased to 6 months, with     molecular monitoring every 3 months and monthly routine laboratory assessments.   "
169469|NCT00056667|"     This study will evaluate the relative effectiveness of Relaxation Response (RR) training for     the treatment of rheumatoid arthritis (RA). The study will compare RR training to RR training     with cognitive behavioral therapy and to a standard RA education program.   "
169266|NCT00044317|"     This study was designed to follow a group of adolescents who were previously examined by     questionnaire and pulmonary function tests when they were aged 8-10 years old. Approximately     50% of the population in 10 towns were seen again at age 17-18. Questionnaires and pulmonary     function were repeated. The hypotheses being tested related to whether the previously seen     levels of pulmonary function that were related to pollution levels in the towns persisted as     the lungs of these children grew and whether dietary antioxidants influences level of     attained pulmonary function.   "
169267|NCT00044343|"     The purpose of this study is to determine the efficacy of an oral investigational drug in     patients with refractory metastatic colorectal cancer after receiving prior therapy with     5-fluorouracil in combination with irinotecan and/or oxaliplatin.   "
169268|NCT00044356|"     The purpose of this clinical trial is to determine if Allovectin-7®, an experimental     gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this     treatment can improve the time to disease progression.   "
169269|NCT00044369|"     Varicose veins in the scrotum (varicocele) are responsible for >20% of male infertility in     the US. Varicocele are associated with decreased sperm number and markedly reduced sperm     fertilizing ability. Surgical repair or removal of varicocele restores fertility in only 1/3     of cases. The goal of this study is to identify markers that predict the outcome of variocele     correction. This would offer considerable health cost savings.      Based on preliminary findings, we will obtain testis biopsies and semen specimens from     infertile men with varicocele and prospectively examining the levels of cadmium, a toxic     metal, and expression of genes required for normal sperm function. The semen and biopsies     will be obtained during clinically dictated procedures. Cadmium and gene expression will be     compared with response to varicocele repair (i.e., increased sperm production; pregnancy).   "
169270|NCT00044382|"     To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience     erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .   "
169271|NCT00044395|"     The purpose of this protocol is to determine if an investigational drug is effective in     treating nerve malfunction in diabetes.   "
169272|NCT00044408|"     The purpose of this protocol is to determine if an investigational drug known as LY333531 is     effective in treating nerve malfunction in diabetes.   "
169273|NCT00044421|"     The purpose of this protocol is to determine if an investigational drug is effective in     treating nerve malfunction in diabetes.   "
169274|NCT00044434|"     The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in     patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients     will receive either a time-released bupropion or placebo. Both groups will receive nicotine     replacement therapy during the 9 week study. A final followup assessment will be conducted 6     months from the start of treatment.   "
169275|NCT00044447|"     The purpose of this study is to assess the efficacy and safety of Amaryl when added to     Metformin and Thiazolidinedione (TZD) in non-insulin dependent diabetes mellitus (NIDDM)     patients.   "
169276|NCT00044460|"     The purpose of this study is to gain safety and efficacy information in patients with type 2     diabetes, who have not previously taken any oral antidiabetic medications, and who have an     HbA1c value of greater than or equal to 10%, despite diet and exercise.   "
169277|NCT00044473|"     The purpose of the study is to assess the rate of elimination of bacteria by levofloxacin in     middle ear fluid of children with a rapid and severe onset of infection and inflammation of     the middle ear who are at high risk for infections that are difficult to treat.   "
169278|NCT00044486|"     This trial is in high risk patients to determine the safety and efficacy of posaconazole vs.     fluconazole in the prophylaxis against development of invasive fungal infections.      Profound, prolonged neutropenia (Absolute neutrophil count<500 cells/cubic mm for at least 7     days) due to induction chemotherapy for acute myelogenous leukemia, or myelodysplastic     syndrome.      Treatment Duration: maximum of 12 weeks Follow-Up 2 months. Endpoints: incidence of proven or     probable IFI according to EORTC/MSG criteria within the neutropenic episode and within 100     days of randomization as determined by external expert review.   "
169279|NCT00044512|"     Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response     or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular     carcinoma.   "
169299|NCT00044772|"     The primary objective is to determine the efficacy, safety, and tolerability of venlafaxine     extended release (ER) capsules in the treatment of outpatients with panic disorder (PD) in     comparison to those of placebo.   "
169280|NCT00044525|"     Breast cancer is the most common form of cancer among women in developing countries,     accounting for approximately one-fifth of all female cancers in the United States. Although     mortality rates are declining in some countries, it remains the leading cause of death in     women aged 40-55 years. The median survival for women with metastatic breast cancer is 2-3     years but there is significant variability in this population. The primary goals of treatment     in patients with metastatic breast cancer are improvement or maintenance of quality of life     and prolongation of survival. The taxanes, paclitaxel and docetaxel, were incorporated into     the treatment of metastatic breast cancer in the 1990's. The usefulness of the taxanes is     limited by the development of tumor resistance to these agents. This phase II trial with     BAY59-8862 will be conducted to determine the anti-tumor efficacy of BAY59-8862 in     taxane-resistant metastatic breast cancer.   "
169281|NCT00044538|"     Lung cancer is among the most common cancers in the world and its incidence continues to     increase. Chemotherapy for patients with Non-Small Cell Lung Cancer (NSCLC) has been under     investigation for several decades and several new drugs with activity in NSCLC have been     identified. These include the taxanes, which are among the most commonly used class of     chemotherapy agents in clinical oncology today. The usefulness of the taxanes is limited by     the development of tumor resistance to these agents. This phase II trial with BAY 59-8862     will be conducted to determine the anti-tumor efficacy of BAY 59-8862 in taxane-resistant     NSCLC.   "
169348|NCT00045565|"     This phase I trial is studying the side effects and best dose of arsenic trioxide and     radiation therapy in treating patients with newly diagnosed malignant glioma. Drugs such as     arsenic trioxide may stop the growth of malignant glioma by stopping blood flow to the tumor.     Radiation therapy uses high-energy x-rays to damage tumor cells. Combining arsenic trioxide     with radiation therapy may kill more tumor cells.   "
169282|NCT00044551|"     Almost two-thirds of lymphoma cases are Non-Hodgkin's Lymphomas (NHL). NHL is a malignant     process that affects lymphoid cells found both in the lymph nodes and extranodally. Incidence     and mortality rates from NHL are highest in developed countries. While many patients with     aggressive NHL are curable with initial anthracycline-containing regimens, the majority of     patients will relapse or prove refractory to initial therapy. The prognosis of patients with     disease recurrence following a multidrug regimen is also limited. The current protocol is     designed to test the safety and efficacy of BAY 59-8862 in patients with Aggressive     Refractory Non-Hodgkin's Lymphoma.   "
169283|NCT00044564|"     In patients with renal cell cancer, most frequent methods of treatment include surgery,     chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered     to be radioresistant and chemoresistant. In patients with metastatic disease, the options are     limited. The taxanes are among the most commonly used class of chemotherapy agents in     clinical oncology today but they are not effective in renal cancers; the development of Bay     59-8862 targets taxane-resistant tumors and the current protocol is designed to test the     safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.   "
169284|NCT00044577|"     A 48-week study to investigate the safety and effectiveness of a new compact formulation of     two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment     for their HIV infection.   "
169285|NCT00044590|"     Parkinson's disease (PD) occurrence is higher in rural than in urban populations of     industrialized countries. Epidemiologic and human tissue studies suggest that pesticides may     be responsible for causing dopaminergic cell death at increased rates. While many     pathophysiologic pathways may be involved in the neurodegeneration responsible for PD,     genetic factors are likely to determine a general susceptibility to neurodegeneration.   "
169286|NCT00044603|"     The goal of this study is to examine the effects of in utero and postnatal exposure to     environmental pollutants in a cohort of pregnant women and their newborns in Krakow, Poland   "
169287|NCT00044616|"     This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®),     lithium, the combination of these two medications, and placebo in treating and preventing     recurrent depressive episodes in people with bipolar type II disorder.   "
169288|NCT00044629|"     This study will determine how sleeping pills can be combined with nondrug treatments to     maximize the benefits of therapy for insomnia.   "
169289|NCT00044642|"     This study will compare the effects of an acute dose of lorazepam to a placebo in elderly     patients with generalized anxiety disorder (GAD).   "
169290|NCT00044655|"     This study will evaluate the effectiveness of switching medications in decreasing     schizophrenia symptoms in individuals who are currently taking an antipsychotic medication     for the treatment of schizophrenia.   "
169291|NCT00044668|"     This multi-center, open-label study is designed to examine the effects on long-term glucose     control and safety of AC2993 in patients with type 2 diabetes treated with metformin,     sulfonylurea, or metformin and sulfonylurea combination.   "
169292|NCT00044681|"     The purpose of this study is to evaluate the effectiveness and safety of risperidone to     augment SSRI therapy in patients with treatment-resistant depression and to demonstrate the     long-term maintenance effect of risperidone as augmentation therapy compared with placebo     augmentation in these patients.   "
169293|NCT00044694|"     This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response     study to examine the effects on glucose control of AC2993 as compared to placebo in patients     with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with     metformin for at least 3 months prior to screening. Patients whose diabetes management     consists of diet and exercise will also be eligible for this study.   "
169294|NCT00044707|"     This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect     of pramlintide on the pharmacokinetics of an orally administered medication   "
169295|NCT00044720|"     The incidence of efficacy failure at 12 months between two regimens.   "
169296|NCT00044733|"     The primary objective of this study is to evaluate the safety of gemtuzumab ozogamicin in     relapsed CD33-positive AML patients who received HSCT. If the MTD dose is not reached, 9     mg/m2 will be the maximum tested dose. A secondary objective is to assess efficacy in terms     of the number of patients attaining a complete (CR) or morphological (CRp) remission.   "
169297|NCT00044746|"     Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy     and Safety data in Diabetic Inpatients.   "
169298|NCT00044759|"     To compare the safety and efficacy of piperacillin/tazobactam (4 g/500 mg) administered     intravenously every 6 hours to cefepime (2 g) administered intravenously every 8 hours for     the empiric treatment of neutropenic fever in patients with a hematologic malignancy or     lymphoma.   "
169300|NCT00044785|"     CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for     colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could     increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU,     leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well     tolerated and therefore potentially increase effectiveness.   "
169301|NCT00044798|"     This 12-week study will evaluate the effectiveness of repetitive transcranial magnetic     stimulation (rTMS) of the brain, followed by citalopram (Celexa®), for treatment of     depression associated with small vascular lesions in the brain (vascular depression).   "
169302|NCT00044811|"     The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID     compared to placebo in the treatment of subjects with mild to moderate persistent asthma   "
169303|NCT00044824|"     The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID     compared to placebo in the treatment of subjects with mild to moderate persistent asthma   "
169304|NCT00044837|"     The purpose of this study is to find out if the anti-HIV drugs nelfinavir (NFV),     lopinavir/ritonavir (LPV/r), and efavirenz (EFV) change the amount of estrogen in the blood     when taken along with hormone replacement therapy (HRT) for menopause.      HRT can be helpful for treating bothersome symptoms of menopause. However, it is not     routinely used in HIV-infected postmenopausal women because it is not known how HRT interacts     with anti-HIV drugs. The information obtained from this study will help doctors make     recommendations for HRT in postmenopausal HIV-infected women.   "
169305|NCT00044863|"     This is a phase II, multicenter, target enrollment of 250 evaluable patients, open-label     study of cetuximab in patients with refractory, metastatic colorectal carcinoma. Based on     prior studies, we predict that 70 to 75% of patients will be EGFR-positive. Patients must     have documented failure after receiving either at least two chemotherapy regimens for     metastatic disease or adjuvant therapy plus one chemotherapy regimen for metastatic disease     provided that the patient progressed within 6 months of completing adjuvant therapy. Prior     chemotherapy must have included irinotecan, oxaliplatin, and a fluoropyrimidine.      Patients will receive an initial dose of cetuximab, 400 mg/m2, intravenously (i.v.) over 120     minutes, followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes.     Patients who experience unacceptable toxicity or who have progressive disease will not     receive further cetuximab therapy.      Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on     cetuximab therapy. Patients with stable disease or a partial or complete response may     continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued     because of toxicity. Patients who have a partial or complete response must have a     confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating     a response.      In addition, there is a pharmacokinetic companion protocol which will determine the trough     and peak levels of cetuximab in 25 patients enrolled in the study at four to eight centers. A     pharmacologic serum sample for the determination of levels of cetuximab will be obtained     prior to the initial, fourth and sixth cetuximab infusions and 1 hour following the     completion of the initial, fourth and sixth cetuximab infusions in the first course; and     prior to and 1 hour post the completion of the first cetuximab infusion of each subsequent     course of therapy. A course of therapy is defined as six weekly infusions of cetuximab     monotherapy. ImClone will perform the pharmacokinetic analyses.   "
169306|NCT00044876|"     Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in     premenopausal women. These tumors may cause bleeding, pelvic pain and pressure. Because     fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels     (like GnRH analog) cause fibroids to shrink and so may relieve symptoms. However, such     medication can only be given short-term and has inconvenient side effects such as     hot-flushes. Thus, many women with symptomatic fibroids choose to have them removed     surgically, either individually or by removing the uterus via hysterectomy.      The study evaluates a new medical treatment for fibroids using the progesterone receptor     modulator CDB-2914. A similar compound, mifepristone (Registered Trademark), reduced fibroid     size when given for twelve weeks. This study will compare fibroid size, hormone levels and     symptoms before and during daily administration of CDB-2914 (10 or 25 mg) or placebo for 10 -     14 weeks. To do this, women will undergo MRI and a saline hysterosonogram (ultrasound with     fluid) of the uterus before and at the end of the treatment; they will have blood drawn every     7 - 14 days, and will fill out a symptom calendar at home. Hysterectomy will be performed at     the end of the treatment to evaluate the effects of the medication on the uterine and fibroid     tissues, and to provide treatment for the study participant. Women will be randomly assigned     to the treatment groups; during the treatment period neither the participants nor the     investigators will know the type of treatment that a woman receives.   "
169307|NCT00044889|"     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia     (ALL) who have had at least 2 prior treatment regimens.      This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with     refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be     refractory to one or two induction regimens, or have relapsed < one year from the date of     confirmation of the initial complete remission (CR). There will be two phases in this study -     an Induction phase and a Consolidation phase.   "
169308|NCT00044902|"     Epratuzumab is currently being studied in combination with rituximab, for the treatment of     patients with low-grade NHL who failed previous chemotherapy and have never received     rituximab or who received rituximab as a single agent or in combination with chemotherapy as     their last treatment and who demonstrated a partial response or complete response for at     least 12 months.   "
169309|NCT00044915|"     The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic     stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1     ratio. The total treatment period wil be 72 hours.   "
169310|NCT00044928|"     A Phase IV, multicenter study of hospitalized patients with complicated intra-abdominal     infection.   "
169311|NCT00044954|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the     doctor to give higher doses of chemotherapy drugs and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with     fludarabine and donor peripheral stem cell transplantation in treating patients who have     hematologic cancer.   "
169312|NCT00044967|"     RATIONALE: Identifying gene mutations (microsatellite instability) may allow doctors to plan     effective treatment for patients who develop colorectal cancer at an early age.      PURPOSE: Genetic trial to determine the significance of gene mutations in helping predict the     outcome of treatment in patients who develop stage I, stage II, or stage III colorectal     cancer at an early age.   "
169313|NCT00044980|"     RATIONALE: An individualized, computer-designed health program may promote changes in diet     and physical activity and may improve quality of life in patients who have early-stage     prostate cancer.      PURPOSE: Randomized clinical trial to compare the effectiveness of an individualized,     computer-designed diet and exercise-based counseling program with that of a standard     counseling program in promoting health in patients who have early-stage prostate cancer.   "
169314|NCT00044993|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Inserting the p53 gene into the tumor may increase the     effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.     Combining chemotherapy with gene therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with gene     therapy in treating patients who have stage III or stage IV breast cancer.   "
169315|NCT00045006|"     RATIONALE: Suberoylanilide hydroxamic acid may stop the growth of cancer cells by blocking     the enzymes necessary for cancer cell growth.      PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in     treating patients who have advanced cancer.   "
169316|NCT00045019|"     RATIONALE: Questionnaires may help determine cancer patients' satisfaction with the quality     of care they received in the hospital.      PURPOSE: Clinical trial to determine the effectiveness of questionnaires in assessing cancer     patients' satisfaction with the quality of care they received in the hospital.   "
169401|NCT00054015|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have     advanced prostate cancer that has been previously treated with hormone therapy.   "
169317|NCT00045032|"     The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus     observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have     completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if     applicable. Efficacy and safety will be assessed for 10 years from randomization for each     participant. All participants will continue to be followed for survival until 10 years after     enrollment of the last participant.   "
169318|NCT00045045|"     RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to     detect the extent of cancer and allow doctors to plan more effective treatment for patients     who have testicle cancer.      PURPOSE: Diagnostic trial to study the effectiveness of positron emission tomography using     fludeoxyglucose F 18 in predicting relapse in patients who have stage I germ cell tumor of     the testicle.   "
169319|NCT00045097|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with     locally advanced or metastatic breast cancer.   "
169320|NCT00045110|"     Phase I/II trial to study the effectiveness of erlotinib in treating patients who have     recurrent malignant glioma or recurrent or progressive meningioma. Erlotinib may stop the     growth of tumor cells by blocking the enzymes necessary for tumor cell growth.   "
169321|NCT00045123|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. R-flurbiprofen may be effective in delaying the recurrence of     localized prostate cancer.      PURPOSE: Randomized phase II trial to study the effectiveness of R-flurbiprofen in treating     patients who have localized prostate cancer at risk of recurrence following radiation therapy     and/or prostatectomy.   "
169322|NCT00045136|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Holmium Ho 166 DOTMP may deliver radiation directly to cancer     cells and cause less damage to normal tissue. Combining chemotherapy and holmium Ho 166 DOTMP     with peripheral stem cell transplantation may allow the doctor to give higher doses of     chemotherapy and holmium Ho 166 DOTMP and kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining holmium Ho 166 DOTMP with     melphalan and peripheral stem cell transplantation in treating patients who have multiple     myeloma.   "
169323|NCT00045149|"     RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to     stimulate the immune system and stop cancer cells from growing. Treating a person's white     blood cells in the laboratory and then reinfusing them may cause a stronger immune response     and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients     who have metastatic melanoma.   "
169324|NCT00045162|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether cisplatin combined with irinotecan is more effective than cisplatin     combined with etoposide in treating extensive-stage small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with     either irinotecan or etoposide in treating patients who have extensive-stage small cell lung     cancer.   "
169325|NCT00045175|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Topotecan may stop the growth of tumor cells by blocking the     enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more     tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with topotecan in     treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or     primary peritoneal cavity cancer.   "
169326|NCT00045188|"     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have     metastatic breast cancer. Imatinib mesylate may stop the growth of cancer by blocking the     enzymes necessary for tumor cell growth   "
169327|NCT00045201|"     Phase I trial to study the effectiveness of combining erlotinib hydrochloride with irinotecan     hydrochloride in treating patients who have advanced solid tumors. Erlotinib hydrochloride     may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining erlotinib hydrochloride and chemotherapy may kill more tumor cells.   "
169328|NCT00045227|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs     used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or     without docetaxel in treating patients who have metastatic prostate cancer.   "
169329|NCT00045266|"     RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by     stopping blood flow to the cancer.      PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in treating patients who have     relapsed or refractory solid tumors or non-Hodgkin's lymphoma.   "
169330|NCT00045279|"     RATIONALE: PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood flow     to the tumor.      PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating     patients who have metastatic kidney cancer.   "
169331|NCT00045292|"     RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in     preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing     cytomegalovirus in patients undergoing stem cell transplantation.      PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in     preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.   "
169349|NCT00045591|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth and by stopping blood flow to the tumor. It is not yet known which regimen of     celecoxib is more effective in treating breast cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib     in treating women who have metastatic or recurrent breast cancer   "
169621|NCT00049530|"     RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping     blood flow to the tumor.      PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating     patients who have stage IV melanoma.   "
169332|NCT00045305|"     RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside     the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation     therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune     system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor     effect). Sometimes the transplanted cells from a donor can also make an immune response     against the body's normal cells. Giving pentostatin before transplant and cyclosporine or     mycophenolate mofetil after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving pentostatin together with     photopheresis and total-body irradiation work before donor bone marrow transplant in treating     patients with myelodysplastic syndromes.   "
169333|NCT00045318|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of exatecan mesylate in treating patients     who have advanced solid tumors and kidney dysfunction.   "
169334|NCT00045331|"     RATIONALE: Proteins found in blood and urine samples may help predict outcome and allow     doctors to plan more effective treatment.      PURPOSE: Diagnostic trial to study blood and urine proteins in predicting treatment outcome     in patients who are undergoing radiation therapy for prostate cancer.   "
169335|NCT00045357|"     RATIONALE: Biological therapies use different ways to stimulate the immune system and stop     tumor cells from growing. Treating a person's white blood cells in the laboratory and     reinfusing them may cause a stronger immune response and kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients     who have metastatic melanoma.   "
169336|NCT00045370|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Biological therapies such as interferon alfa use different ways to     stimulate the immune system and stop cancer cells from growing. Combining biological therapy     with chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with biological     therapy in treating patients who have locally advanced or metastatic kidney cancer.   "
169337|NCT00045396|"     Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their     growth. Phase II trial to study the effectiveness of tipifarnib in treating patients who have     acute myeloid leukemia or myelodysplastic syndrome in first complete remission   "
169338|NCT00045422|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Imatinib mesylate     may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.     Combining interferon alfa with imatinib mesylate may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with imatinib     mesylate in treating patients who have chronic myelogenous leukemia.   "
169339|NCT00045435|"     This phase II trial studies how well reduced intensity donor peripheral blood stem cell     (PBSC) transplant works in treating patients with de novo or secondary acute myeloid leukemia     (AML) in remission. Giving low doses of chemotherapy, such as fludarabine phosphate, and     total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer     cells. It may also stop the patient's immune system from rejecting the donor's stem cells.     The donated stem cells may replace the patient's immune cells and help destroy any remaining     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can     also make an immune response against the body's normal cells. Giving cyclosporine and     mycophenolate mofetil after the transplant may stop this from happening   "
169340|NCT00045448|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with docetaxel in     treating patients who have advanced solid tumors.   "
169341|NCT00045461|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several     degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor     cells. It is not yet known if chemotherapy is more effective with or without whole-body     hyperthermia therapy in treating gynecologic cancer.      PURPOSE: Randomized phase II/III trial to compare the effectiveness of chemotherapy with or     without whole-body hyperthermia in treating patients who have recurrent ovarian epithelial,     fallopian tube, or peritoneal cancer.   "
169342|NCT00045474|"     RATIONALE: Brachytherapy uses radioactive material to kill cancer cells remaining after     surgery.      PURPOSE: Phase I trial to study the effectiveness of brachytherapy in treating patients who     have recurrent malignant glioma.   "
169343|NCT00045487|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have     advanced kidney cancer.   "
169344|NCT00045500|"     RATIONALE: UCN-01 may stop the growth of cancer cells by blocking the enzymes necessary for     cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from     dividing so they stop growing or die. Combining UCN-01 with prednisone may kill more cancer     cells.      PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with prednisone in     treating patients who have refractory solid tumors or lymphoma.   "
169345|NCT00045513|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining UCN-01 with fludarabine in     treating patients who have relapsed or refractory chronic lymphocytic leukemia or lymphocytic     lymphoma.   "
169346|NCT00045526|"     This phase II trial is studying erlotinib hydrochloride to see how well it works in treating     patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop     the growth of cancer by blocking the enzymes necessary for tumor cell growth.   "
169347|NCT00045539|"     RATIONALE: Drugs used in chemotherapy, such as methotrexate and thiotepa, work in different     ways to stop cancer cells from dividing so they stop growing or die. Combining more than one     drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining methotrexate with thiotepa in     treating patients who have newly-diagnosed primary CNS lymphoma.   "
169350|NCT00045604|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes     necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die. Combining imatinib mesylate with     chemotherapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining imatinib mesylate with     irinotecan and cisplatin in treating patients who have extensive-stage small cell lung cancer   "
169351|NCT00045617|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells.     Vaccines may make the body build an immune response to kill tumor cells. Combining     chemotherapy and radiation therapy with vaccine therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation     therapy with vaccine therapy in treating patients who have limited-stage small cell lung     cancer.   "
169352|NCT00045630|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells and decrease     the need for surgery.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by     observation or surgery to remove the bladder (cystectomy) in treating patients who have stage     II or stage III cancer of the urothelium.   "
169353|NCT00045669|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes     necessary for tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients     who have unresectable and/or metastatic salivary gland cancer.   "
169354|NCT00045682|"     Phase II trial to study the effectiveness of CT-2103 in treating patients who have recurrent     or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die.   "
169355|NCT00045695|"     RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for     tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who     have untreated or relapsed Waldenstrom's macroglobulinemia.   "
169356|NCT00045708|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. This phase I/II trial is studying the side effects and best dose of     ixabepilone and how well it works in treating patients with recurrent glioma.   "
169357|NCT00045721|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Chemotherapy placed into the surrounding tissue after surgery to     remove the tumor may kill any remaining tumor cells. O(6)-benzylguanine may increase the     effectiveness of carmustine by making tumor cells more sensitive to the drug.      PURPOSE: Phase I trial to study the safety of combining O(6)-benzylguanine with carmustine     implants in treating children who have recurrent malignant glioma.   "
169358|NCT00045734|"     Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have     recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the     enzymes necessary for tumor cell growth   "
169359|NCT00045747|"     RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with fluorouracil in     treating patients who have metastatic pancreatic cancer that has not responded to treatment     with gemcitabine.   "
169360|NCT00045760|"     Severe sepsis is defined as a systemic inflammatory response syndrome that results from     infection and is associated with acute organ dysfunction. It usually results from bacterial     infections, but it may occur in response to other pathogens, such as fungi, viruses, and     parasites.   "
169361|NCT00045773|"     This 12-week study will evaluate the effectiveness of sertraline (Zoloft®) for treatment of     depression associated with small vascular lesions in the brain (vascular depression).   "
169362|NCT00045786|"     The primary objective of the study is to assess the safety of CC-1088 to patients with     myelodysplastic syndromes (MDS).   "
169503|NCT00057122|"     This study compares three different tuberculosis (TB) prevention regimens against the     standard regimen of 6 months of isoniazid. It is being conducted in Soweto, South Africa.     People who are HIV positive and have a positive tuberculin skin test without signs of active     tuberculosis may join.   "
169363|NCT00045799|"     Critically ill patients are at an increased risk of having upper gastrointestinal (GI)     bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through     intravenous infusion, is the only drug that the FDA has approved for the prevention of upper     GI bleeding in critically ill patients. The present trial is intended to assess the safety     and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this     indication.   "
169364|NCT00045812|"     This study will test the safety and effectiveness of SCH-58235 (Ezetimibe) in lowering     sitosterol, plant sterol and cholesterol blood levels in patients with homozygous     sitosterolemia when added to the patients' current treatment regimen. Homozygous     sitosterolemia is an inherited disorder of sterol metabolism in which an excess of many plant     sterols, including sitosterol, is absorbed and not enough excreted. (Sterols are substances     used to form hormones, vitamins and membranes found in animal and plant lipids.). Patients     can develop atherosclerosis with coronary heart disease as early as childhood, as well as     other problems including arthritis, arthralgia, and tendon xanthomas (lipid deposits).     Current sitosterolemia treatments may include a low sterol diet, medications, intestinal     surgery, or a combination of these. Ezetimibe is a member of a new class of drugs called     specific cholesterol absorption inhibitors that may lower cholesterol, sitosterol and other     plant sterol blood levels.      Patients with homozygous sitosterolemia 10 years of age and older may be eligible for this     study. Participants will have a medical history and physical examination and will be randomly     assigned to one of two treatment groups. One group, which will include about 80 percent of     all study participants, will take 10 mg of Ezetimibe a day, and the second group (20 percent     of participants) will take a placebo (an inactive look-a-like pill).      Patients will have 7 clinic visits during the 12-week study, when some or all of the     following procedures and tests will be done:        -  Measurement of vital signs (heart rate, blood pressure, breathing rate and temperature)        -  Dietary maintenance - interview about how well that patient is adhering to the diet        -  Medication review - interview about other medications the patient is taking        -  Blood draw for tests        -  Urine sample for tests        -  Pregnancy test for women of childbearing potential        -  Electrocardiogram (ECG) to measure the electrical activity of the heart        -  Blood draw to determine sitosterol, other plant sterol levels, and lipid levels          (cholesterol and other blood lipid concentrations)        -  Xanthoma measurement (with a ruler and X-ray of the foot)   "
169365|NCT00045838|"     This study will test the safety of an experimental vaccine against HIV and examine whether it     induces an immune response to HIV. A vaccine is a substance given to try to create resistance     or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic     material) of four HIV proteins called gag, pol, Nef, and Env. Injected into a human, the     viral DNA instructs the body to make small amounts of some HIV proteins. This study will see     if the body then creates an immune response to these proteins. Study participants cannot     catch HIV or AIDS from the DNA vaccine or any proteins made from it.      Healthy normal volunteers between 18 and 60 years of age may be eligible for this study.     Candidates will provide a medical history, including information on sexual behaviors and drug     use. They will have a physical examination and blood and urine tests. Women will also have a     pregnancy test. Women enrolled in the study must either be infertile (e.g., due to menopause     or hysterectomy) or must agree either to abstain from heterosexual sex or to practice birth     control for at least 21 days before beginning the study and throughout its duration.      Participants will be randomly assigned to receive either the experimental vaccine or a     placebo (a control substance made up of an inactive salt solution) and will be divided into     three groups, based on their entry into the study. Of the first seven people enrolled (Group     1), five will receive a 2-mg dose of vaccine and two will receive placebo. If the vaccine is     safe at this dose, then in Group 2, five people will receive a 4-mg dose of vaccine and two     will receive placebo. If this dose is safe, then in Group 3, thirty people will receive an     8-mg dose of vaccine and six will receive placebo.      All participants will receive three injections in an upper arm muscle-one injection a month     for three months-with a needle-less device called a Biojector 2000® (Registered Trademark).     At the time of each injection, participants will be observed for at least 1 hour after     immunization. At home, they will record their temperature and any symptoms they may     experience, including any effects at the injection site, for at least 2 days, or as long as     the symptoms remain. If symptoms occur, participants will report them immediately to the     clinic staff and, if necessary, come to the clinic for an examination.      Participants will have about 10 clinic visits during the study. Most visits will last about 2     hours; those on vaccination days will last about 4 hours. At each visit, participants will be     checked for health changes or problems and will be asked about medications they are taking.     Blood will be drawn for immune system testing. Additional laboratory tests may be requested     between visits. Participants will be tested several times for HIV, will be questioned about     their sexual behavior and drug use, and about social effects they may have experienced from     their participation in the study.      Some of the blood drawn for this study will be used to test for HLA type-a genetic test of     immune system markers. For research, HLA testing is sometimes used to try to identify factors     associated with the progression of HIV disease or related conditions.   "
169370|NCT00045942|"     CPKC412A2104 core had a 2 stage design. In stage 1, eight participants were treated. If at     least one participant showed a clinical response, four more participants were recruited to     stage 2. The trial was to be stopped if no participants showed a response in stage 1. POC was     achieved if at least 2 participants out of 12 responded. In PKC412A2104E1, participants with     AML or high risk MDS with wild-type or mutant FTL3 who had not previously received a FLT3     inhibitor were randomized to receive continuous twice daily oral doses of either 50 or 100 mg     midostaurin in 1 28-day cycle regimen. Participants were to be treated until disease     progression or the occurrence of unacceptable treatment-related toxicity. PKC412A2104 E2     contained 2 dosing regimens: 1) intra-participant midostaurin dose escalation and 2)     midostaurin with itraconazole in participants with AML and high risk MDS irrespective of FLT3     status. Eligible participants were alternately assigned to the regimens. At the     Investigator's discretion, intra-participant dose escalation was allowed for any previously     enrolled CPKC412A2104E1 participant receiving midostaurin at the time of the approval of     amendment 4. Participants were treated until the time of disease progression.   "
169371|NCT00045955|"     The purpose of this study is to assess the long-term safety performance of fexofenadine     compared to montelukast in subjects with asthma   "
169372|NCT00045968|"     The primary purpose of the study is to determine the efficacy of an investigational therapy     called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated.     Patients must enter screening at a participating site prior to surgical resection of the     tumor. Patients will receive the standard of care, including radiation and Temodar therapy     and two out of three will additionally receive DCVax-L, with the remaining one third     receiving a placebo. Patients randomized to the placebo arm will have the option to receive     DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for     patients with brain cancer is sometimes also referred to as DCVax-Brain)   "
169373|NCT00045981|"     The purpose of this study is to evaluate the safety and efficacy of ALT-711 in the treatment     of isolated systolic hypertension in a formal dose-ranging study in patients without left     ventricular hypertrophy. Eligible patients will be randomized to double-blind treatment once     daily for 6 months with oral ALT-711 (35, 70, 140, or 210 mg) or placebo.   "
169374|NCT00045994|"     The purpose of this study is to evaluate the safety and efficacy of ALT-711 in the treatment     of isolated systolic hypertension in a formal study in patients with left ventricular     hypertrophy. Eligible patients will be randomized to double-blind treatment once daily for 6     months with oral ALT-711 (210 mg) or placebo.   "
169375|NCT00046020|"     The purpose of this study is to review the long-term comparative efficacy of venlafaxine ER     in achieving and sustaining remission (wellness) in patients with recurrent major depression   "
169376|NCT00046033|"     The purpose of this study is to see if adjusting the dose of lopinavir/ritonavir (LPV/r) has     a better effect on lowering HIV viral load (the amount of HIV in the blood) compared to     taking the standard FDA-approved LPV/r dose. This study will also compare the safety and     tolerability of these two types of dosing.   "
169412|NCT00054184|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether polyglutamate paclitaxel is more     effective than docetaxel in treating non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel     with that of docetaxel in treating patients who have progressive non-small cell lung cancer.   "
169504|NCT00057135|"     This is a randomized controlled trial examining the effectiveness of a pharmacy-based     intervention designed to improve adherence with antipsychotic medications among patients with     serious mental illness.   "
169377|NCT00046059|"     Attention Deficit Hyperactivity Disorder (ADHD) is the most common behavioral disorder in     childhood, affecting 3-5% of children between the ages of 7 and 17. Family studies suggest     that there is a genetic component to ADHD. Scientists believe that it is a complex disorder     in which two or more genes may be involved.      Potentially eligible families will be asked to give written consent to participate and will     be asked to complete questionnaires for each member in the family. In addition, an interview     will be administered to the parent of minors enrolled in the study to determine their     eligibility for being in the study. This screening tool is computerized and will take     approximately 45 minutes to administer per child.      Once screenings are completed, a blood collection kit will be sent to the family to take to     their local medical care provider, have blood samples drawn and sent to NIH. There is no cost     to the family to participate. We would like to enroll entire families, with both parents and     all children.   "
169378|NCT00046072|"     Sepsis is a serious condition where there is inflammation and damage to body tissue, usually     caused by an infection. This infection can lead to decreased function of vital body organs     and in some cases may lead to permanent health problems or death.      Much of the injury is due to endotoxin, a harmful substance produced by certain types of     bacteria. An endotoxin antagonist is designed to block the effects of endotoxin.      This study is designed to study the safety and efficacy when treating patients with severe     sepsis.   "
169379|NCT00046085|"     This study evaluated the benefits of providing relatives of patients diagnosed with     schizophrenia the opportunity to interact with each other using the Internet. It was     hypothesized that patients whose relatives had access to the internet intervention would have     reduced symptoms and greater community tenure, compared to their counterparts who did not     have relative access to the internet education and support program. We also collected     information on how frequently the relatives used the website and how well they liked its     features.   "
169380|NCT00046111|"     The purpose of this study is to compare two capsules of topotecan made by slightly different     methods. This will be done by giving the drug made by the two different methods to patients     orally and testing blood levels.   "
169402|NCT00054028|"     This phase I/II trial studies the best dose of suramin when given together with paclitaxel in     treating women with stage IIIB-IV breast cancer. Drugs used in chemotherapy use different     ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the     effectiveness of paclitaxel by making tumor cells more sensitive to the drug.   "
169988|NCT00054847|"     VA patients with coronary artery disease and who have agreed to undergo coronary artery     bypass graft surgery would be randomized to receive either radial artery or saphenous vein to     the study vessel. The primary outcome variable is graft patency at one year.   "
169381|NCT00046124|"     This prospective cohort study assesses the effects of exposure to organophosphate (OP)     pesticides on adverse reproductive outcomes in both male and female agricultural workers in     China. We will enroll women and their spouses, who are attempting to become pregnant, and     observe reproductive endpoints including (1) semen parameters (concentration, total count,     motility, progression and morphology), (2) menstrual disorders (oligomenorrhea, amenorrhea,     polymenorrhea, intermenstrual bleeding, prolonged menstrual bleeding, dysmenorrhea, and     irregular menstruation); (3) alterations in hormone patterns including reduced estrogen     excretion (REE), anovulation, abnormal luteal phase (ALP), and abnormal follicular phase     (AFP) in women and abnormalities of LH, FSH, TSH, SHBG, inhibin-B and testosterone in men;     (4) fecundability; and (5) pregnancy outcomes including spontaneous abortion, preterm     delivery, low birth weight, and intrauterine growth retardation.   "
169382|NCT00046137|"     The purpose of this study is to compare treatment with both teriparatide and raloxifene with     teriparatide alone. The study will evaluate any side effects that may be associated with the     two drugs and may help to determine whether teriparatide and raloxifene together can help     patients with osteoporosis more than teriparatide alone.   "
169383|NCT00046150|"     The purpose of this study is to compare the safety of HMR 1964 and insulin aspart when used     in external pumps with respect to catheter occlusions, GHb assessment, insulin doses, blood     glucose parameters, hypoglycemic episodes, unexplained hyperglycemia, adverse events,     laboratory data, and vital signs.   "
169384|NCT00046163|"     We are seeking male and female patients to voluntarily take part in a clinical research     study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic     hypotension (low blood pressure while in the upright position) due to Parkinson's disease,     multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic     orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness,     changes in vision and generalized weakness upon standing. The main effect of the drug being     studied is to increase blood pressure in the upright position so symptoms will decrease.      The purpose of this clinical study is to further assess the clinical effect of high dose     midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension.     During the course of the study, participants will receive either ProAmatine® or a placebo.     Assessments will be made using questionnaires that measure symptom and activity levels. Blood     pressure in the lying down, sitting and standing positions will be measured. Patients will     also complete standing time assessments. They will be asked to remain standing without moving     until they feel sufficiently lightheaded, or dizzy, or feel faint so that they would feel     more comfortable sitting down.   "
169385|NCT00046176|"     This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose     combination tablet administered once-a-day versus the individual tablets administered     twice-a-day within 3-drug combination regimens in ART (antiretroviral)-experienced HIV-1     infected patients.   "
169386|NCT00046189|"     This study will determine if family members of patients with xeroderma pigmentosum (XP) have     various abnormalities, including: skin abnormalities; nervous system abnormalities, such as     hearing problems; skin, eye, or internal cancers, or other changes. XP is a rare inherited     disease that involves an inability to repair damage to cell DNA (genetic material). It can     affect several organ systems, including the skin, eye, nervous system, and bones. Patients     have a more than thousand-fold increase in frequency in all major skin cancers.      Parents of patients with XP are carriers of the abnormal XP gene. Other family members may     also be carriers of the abnormal XP gene. Carriers do not develop the disease themselves;     symptoms develop only in children who have inherited the faulty gene from both parents. This     study will try to clarify the genetic basis for XP and to understand the increased frequency     of cancer in the disease.      XP patients who have been evaluated at the NIH Clinical Center and their relatives are     eligible for this study. Newly diagnosed XP patients are also eligible. Spouses of relatives     will also be included as control subjects.      Patients and their family members will undergo some or all of the following procedures:        -  Parental permission to review the child s relevant medical records and pathology          material from treatments or surgery for cancer or other related illnesses        -  Medical history and physical examination, with particular attention to the skin and          possible eye, hearing or neurological examinations        -  Photographs to document skin and other physical findings        -  Nuclear medicine scans to evaluate the brain and nervous system        -  X-rays of the skull or other parts of the body        -  Nervous system testing with an electroencephalogram (EEG), electroretinogram (ERG),          electromyogram (EMG) or nerve conduction velocity measurement        -  Collection of blood and skin samples for gene studies        -  Establishment of cell lines from collected blood or tissues to study DNA repair, skin          cancer, cancers related to XP, immune defects, and related studies.        -  Biopsy (surgical removal of a small piece of tissue) of suspicious skin lesions for          examination under a microscope        -  Collection of a cheek cell sample, obtained by twirling a soft brush against the inside          of the cheek        -  Collection of a hair sample for microscopic examination and composition analysis        -  Surgery to treat skin cancers or other lesions   "
169387|NCT00046202|"     This study will investigate the cause and medical problems associated with a group of genetic     disorders known as inborn errors of cholesterol synthesis, in which the body does not produce     cholesterol. People with this disorder may have birth defects and learning and behavioral     problems.      People with an inborn error of cholesterol synthesis and related disorders, including     Smith-Lemli-Opitz syndrome, lathosterolosis, desmosterolosis, X-linked dominant     chondrodysplasia, CHILD syndrome, Greenberg dysplasia, and some cases of Antley-Bixler     syndrome, may be eligible for this study. People who are carriers of the disorders also may     enroll.      Participants and family members will provide blood and urine samples, as well as other tissue     samples collected during medically indicated procedures such as biopsy or surgery. These     tissues may include, for example, gallstones, cataracts, cerebrospinal fluid, amniotic fluid,     lymph tissue, and DNA samples. In rare instances, a skin biopsy may be requested to aid in     establishing a diagnosis.      Medical information will also be gathered from medical records, photographs, and X-rays.   "
169399|NCT00053989|"     RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell     transplant helps stop the growth of cancer cells. It also stops the patient's immune system     from rejecting the donor's stem cells. The donated stem cells may replace the patient's     immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving     an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help     increase this effect. Sometimes the transplanted cells from a donor can also make an immune     response against the body's normal cells. Giving immunosuppressive therapy before or after     the transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well chemotherapy followed by donor peripheral     stem cell transplant works in treating patients with hematologic cancer or aplastic anemia.   "
169400|NCT00054002|"     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to     light to kill cancer cells. Combining photodynamic therapy with surgery may be an effective     treatment for malignant mesothelioma.      PURPOSE: Phase II trial to study the effectiveness of combining photodynamic therapy with     surgery in treating patients who have malignant mesothelioma.   "
169388|NCT00046215|"     This study will use transcranial magnetic stimulation (TMS) to examine the relationship     between cognitive processing and motor control by determining whether a part of the brain     called the premotor cortex is essential to imagining movement. TMS, described below, is a     method of brain stimulation that can temporarily inhibit brain functions of the area     underlying the stimulator.      Healthy right-handed normal volunteers may be eligible for this study. Candidates will be     screened with a medical history, neurological examination, and test of finger dexterity.      Participants will perform a sequential finger tapping movement in response to a series of     numbers (stimuli) displayed on a computer monitor. After 10 stimuli, they will be asked which     finger they tapped last. They will then imagine the same finger tapping movement and will be     asked which finger they tapped last in their imagination. During these exercises,     participants will undergo transcranial magnetic stimulation. For this procedure, the subject     is seated comfortably in a chair. A wire coil is placed on the scalp and a brief electrical     current is passed through the coil, creating a magnetic pulse that passes into the brain.     This generates a very small electrical current in the brain, which briefly disrupts the     function of the brain cells in the stimulated area. The stimulation may cause twitching in     arm or leg muscles. During the stimulation, the electrical activity of muscles is recorded     with a computer or other recording device, using electrodes attached to the skin with tape.      Subjects will complete eight experimental blocks of testing. One block consists of 20     experimental trials, with each trial lasting about 10 seconds. Five pairs of TMS stimuli are     given per trial, with pulses delivered in short bursts of one second each. After each block,     subjects draw a mark on a line on paper, showing how much attention they are paying, how much     fatigue they are experiencing, and how well they think they are executing the tasks. Each TMS     session takes up to 3.5 hours.      Before the TMS session, participants will undergo magnetic resonance imaging (MRI) for use in     determining proper placement of the TMS coil. MRI uses a strong magnetic field and radio     waves to obtain images of body organs and tissues. For this procedure, the subject lies still     in a narrow metal cylinder (the scanner) for about 30 minutes during the scan.   "
169389|NCT00046228|"     The purpose of this study is to determine whether abciximab given in combination with     reteplase, before patients have a coronary intervention (a standard treatment where a     catheter is inserted into the heart artery to get blood flowing past the clot), is safe and     effective in the treatment of heart attacks compared to only abciximab given during coronary     intervention.   "
169390|NCT00046241|"     This is a placebo controlled study evaluating the effectiveness of medication in preventing     depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).   "
169391|NCT00053885|"     RATIONALE: PTK787/ZK 222584 may stop the growth of tumor cells by blocking the enzymes     necessary for tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of PTK787/ZK 222584 in treating patients     with unresectable malignant mesothelioma.   "
169392|NCT00053898|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight     breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by     decreasing estrogen production. It is not yet known whether anastrozole is more effective     than tamoxifen in preventing the recurrence of breast cancer.      PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works     compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women     with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.   "
169393|NCT00053911|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug, and giving them after surgery, may     kill any remaining tumor cells following surgery. It is not yet known whether combination     chemotherapy is more effective than observation in treating relapsed nonmetastatic breast     cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy     with that of observation in treating women who have undergone surgery for relapsed     nonmetastatic breast cancer.   "
169394|NCT00053924|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who     have locally advanced or metastatic pancreatic cancer.   "
169395|NCT00053937|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Pirfenidone may slow the growth or prevent further     development of plexiform neurofibromas.      PURPOSE: Phase I trial to study the effectiveness of pirfenidone in treating young patients     who have neurofibromatosis type 1 and plexiform neurofibroma.   "
169396|NCT00053950|"     This phase I trial is studying the side effects and best dose of pyrazoloacridine given     together with peripheral stem cell or bone marrow transplantation in treating young patients     with high-risk neuroblastoma. Drugs used in chemotherapy use different ways to stop tumor     cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem     cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy     drugs and kill more tumor cells.   "
169397|NCT00053963|"     This phase I trial is studying the side effects and best dose of FR901228 in treating     children with refractory or recurrent solid tumors or leukemia. Drugs used in chemotherapy     use different ways to stop cancer cells from dividing so they stop growing or die   "
169413|NCT00054197|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether polyglutamate paclitaxel is more effective than gemcitabine or vinorelbine     in treating non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel     with that of gemcitabine or vinorelbine in treating patients who have stage IIIB, stage IV,     or recurrent non-small cell lung cancer.   "
169520|NCT00057343|"     The purpose of this study is to provide treatment for patients who have relapsed NHL or     refractory NHL, and to determine the effectiveness and safety of the Zevalin and Rituxan     regimens or Rituxan therapy alone on your disease.   "
169398|NCT00053976|"     The purpose of this study is to compare the effects of IL2 receptor antibody (also known as     Daclizumab or Zenapax) and corticosteroids alone for control of GVHD. Treatment with     corticosteroids is standard care for GVHD. This research is being done because the     investigators do not know whether addition of this new medication to standard corticosteroid     therapy improves response rates. Since Zenapax binds to a type of cell which is thought to     cause GVHD and possibly inactivates them, investigators have reason to believe that addition     of Zenapax night result in better control of GVHD This study will determine whether the     addition of another medication, Zenapax, will be more effective than steroids alone in     suppressing GVHD and improving symptoms of GVHD.      Daclizumab (Zenapax) is approved by the Food and Drug Administration (FDA) for use in patient     with kidney transplant to help prevent graft rejection. This medication has been used in bone     marrow transplant patients to treat GVHD.   "
180397|NCT00186251|"     To evaluate the role of high dose chemotherapy with autologous hematopoietic cell     transplantation in the treatment of Hodgkin's Disease.   "
169403|NCT00054041|"     Vaccines made from antigens may make the body build an immune response to kill abnormal     cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial     to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who     have cervical intraepithelial neoplasia   "
169404|NCT00054054|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation     therapy in treating patients with stage III or stage IV head and neck cancer.   "
169405|NCT00054067|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known which regimen of radiation therapy combined with chemotherapy, with     or without surgery, is more effective in treating early cancer of the cervix.      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery followed by     different regimens of radiation therapy and chemotherapy with that of chemotherapy and     radiation therapy alone in treating patients who have stage I cancer of the cervix.   "
169406|NCT00054106|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as     flutamide and buserelin may stop the adrenal glands from producing androgens. OGX-011 may     help flutamide and buserelin kill more tumor cells by making tumor cells more sensitive to     the drugs. Giving flutamide and buserelin with OGX-011 before surgery may shrink the tumor so     it can be removed during surgery.      PURPOSE: Phase I trial to study the effectiveness of combining hormone therapy with OGX-011     before radical prostatectomy in treating patients who have prostate cancer.   "
169407|NCT00054119|"     Phase II trial to study the effectiveness of karenitecin in treating patients who have     persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not     responded to platinum-based treatment. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die.   "
169408|NCT00054132|"     This phase II trial studies how well erlotinib hydrochloride and bevacizumab work in treating     patients with stage IV breast cancer. Erlotinib hydrochloride may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving     erlotinib hydrochloride and bevacizumab may be an effective treatment for breast cancer.   "
169409|NCT00054145|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who     have recurrent, refractory, locally advanced, or metastatic breast cancer.   "
169410|NCT00054158|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from     dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping     blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and     thalidomide in treating patients who have newly diagnosed stage I, stage II, or stage III     multiple myeloma.   "
169411|NCT00054171|"     RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to     light to kill cancer cells. Photosensitizing drugs such as aminolevulinic acid are absorbed     by cancer cells and, when exposed to light, become active and kill the cancer cells.      PURPOSE: Randomized phase II trial to study the effectiveness of photodynamic therapy using     aminolevulinic acid in treating patients who have cutaneous T-cell lymphoma, B-cell lymphoma,     or early chronic lymphocytic leukemia involving the skin.   "
169414|NCT00054210|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which regimen of chemotherapy is more effective in treating stage IIIB, stage IV,     or recurrent non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel     plus carboplatin to that of paclitaxel plus carboplatin in treating patients who have stage     IIIB, stage IV, or recurrent non-small cell lung cancer.   "
169415|NCT00054223|"     RATIONALE: Studying individuals who are enrolled in phase I clinical trials may help to     improve the way in which clinical trials are conducted.      PURPOSE: This clinical trial is studying patients' personality traits, reasons for     participating in the trial, and understanding of their medical situation, prognosis, and     risks and benefits of participating in a phase I trial.   "
169416|NCT00054236|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Umbilical cord blood transplantation may be able to replace     cells destroyed by chemotherapy.      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by     umbilical cord blood transplantation in treating patients who have hematologic cancer or     severe aplastic anemia.   "
169417|NCT00055913|"     This randomized phase I/II trial is to see if combining erlotinib with bevacizumab works     better in treating patients who have recurrent or metastatic head and neck cancer. Erlotinib     may stop the growth of tumor cells by blocking the enzymes needed for tumor cell growth.     Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or deliver cancer-killing substances to them. Combining erlotinib with bevacizumab may     kill more tumor cells.   "
169418|NCT00055926|"     RATIONALE: CP-724,714 may stop the growth of tumor cells by blocking the enzymes necessary     for tumor cell growth.      PURPOSE: Phase I trial to study the effectiveness of CP-724,714 in treating patients who have     metastatic HER2-overexpressing breast cancer.   "
169419|NCT00055939|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating children     who have relapsed or refractory rhabdomyosarcoma.   "
169470|NCT00056680|"     This study evaluated the efficacy of a comprehensive, three-part program for parents of     premature infants. This program was designed to improve development in preterm children and     includes an educational video, tests to evaluate the child's strengths and abilities, and     instruction in infant massage.   "
169420|NCT00055952|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients     who have relapsed or refractory Ewing's sarcoma or peripheral primitive neuroectodermal tumor     or desmoplastic small round cell tumor.   "
169421|NCT00055965|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known if one regimen will require patients to spend more time in the hospital than the     other regimen for treatment of chemotherapy-related side effects.      PURPOSE: Randomized phase III trial to compare the hospitalization rates of patients who are     receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine     combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer.   "
169422|NCT00055978|"     RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or     recurrence of cancer. Celecoxib may be effective in preventing the development or recurrence     of lung cancer in former heavy smokers.      PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing the     development or recurrence of lung cancer in former heavy smokers who are at risk of     developing cancer.   "
169423|NCT00055991|"     RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or     recurrence of cancer. It is not yet known whether bexarotene is effective in preventing     breast cancer.      PURPOSE: Randomized clinical trial to study the effectiveness of bexarotene in preventing     breast cancer in women who are at genetic risk of developing breast cancer.   "
169424|NCT00056004|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of zileuton may be an effective way to prevent     lung cancer in patients who have bronchial dysplasia.      PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung     cancer in patients who have bronchial dysplasia.   "
169425|NCT00056030|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and     either kill them or deliver tumor-killing substances to them without harming normal cells.     Combining chemotherapy with cetuximab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with cetuximab works in treating patients with unresectable liver metastases from colorectal     cancer.   "
169426|NCT00056056|"     RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more     sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy     is more effective with or without bexarotene in treating mycosis fungoides.      PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy     using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.   "
169427|NCT00056069|"     RATIONALE: Studying the physical and emotional needs of parents who are caring for children     receiving chemotherapy for cancer may help doctors plan effective treatments for the patient     that allow for improved quality of life of the patient's family.      PURPOSE: This clinical trial is studying the different physical and emotional needs of     parents whose children are undergoing chemotherapy for acute lymphoblastic leukemia either in     an outpatient clinic or in the hospital.   "
169428|NCT00056082|"     RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or     recurrence of cancer. Celecoxib may be effective in preventing breast cancer in at-risk     women.      PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing breast cancer     in premenopausal women who are at risk of developing cancer.   "
169464|NCT00056589|"     This trial was conducted in the United States of America (USA). The aim of this trial was to     investigate safety and pharmacokinetics of escalating single doses of catridecacog     (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.   "
169429|NCT00056095|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may     allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in     treating patients with metastatic kidney cancer.   "
169430|NCT00056134|"     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make     the body build an immune response to kill tumor cells. Biological therapies such as     denileukin diftitox may be able to deliver cancer-killing substances directly to melanoma     cells. Combining vaccine therapy with biological therapy may kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining vaccine therapy with     denileukin diftitox in treating patients who have stage III or stage IV melanoma.   "
169431|NCT00056147|"     The purpose of this study is to assess the safety and effectiveness of multiple dosages of     INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis     (CF) lung disease. Study drug will be administered through a nebulizer (a device that     delivers medication as a mist by breathing it in).   "
169432|NCT00056160|"     Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing     identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will     participate in a treatment phase and a follow-up phase.   "
169433|NCT00056173|"     This phase II, 43 patient trial, will evaluate the efficacy of GTI-2040, an antisense     oligonucleotide complementary to the R2 component of ribonucleotide reductase (RNR) mRNA, in     combination with capecitabine, in the setting of advanced/metastatic renal cell carcinoma.     Preclinical studies have shown synergy between GTI-2040 and capecitabine against renal cell     carcinoma.   "
169467|NCT00056641|"     This is an open-label, randomized, parallel group pharmacokinetics trial of     tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV),     amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple     antiretroviral (ARV) experienced HIV-1 patients.      The primary objective is to determine the safety and pharmacokinetics of:      TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination     with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).   "
169434|NCT00056186|"     The purposes of this study are to learn about significant life changes for people with     Friedreich's ataxia and about patients' experiences with health care providers. Friedreich's     ataxia is a rare genetic disorder in which patients experience progressive muscle weakness     and loss of coordination in the arms and legs. They may have other complications, such as     vision and hearing impairment, dysarthria, scoliosis, diabetes, and heart disease. The study     will explore the impact of this chronic progressive illness on transitional life events, such     as career choice and marriage, and the role of family members and health care     providers-particularly genetic counselors-in helping patients progress through these events.      Patients with Friedreich's ataxia who are 18 years of age or older may be eligible for this     study. Those enrolled will participate in a 45- to 60-minute interview by phone or in person,     in which they will be asked questions about important changes in their lives and their past     experiences with health care providers. The interview will be audiotaped.   "
169435|NCT00056199|"     This study will test the ability of the experimental drug EYE001 to reduce retinal thickening     and improve vision in patients with Von Hippel-Lindau syndrome (VHL). Angiomas (blood vessel     tumors) commonly develop in the back of the eye on the retina and the optic nerve in patients     with VHL. Although the tumors are not cancerous, they may cause significant vision loss.     Current treatments, including laser therapy, cryotherapy, and vitrectomy, may not be     successful or possible for all patients. EYE001 decreases production of VEGF, a growth factor     that is important for the formation of new blood vessels and that is elevated in VHL.     Preliminary findings from studies of other retinal diseases suggest that EYE001 can reduce     retinal thickening and improve vision.      Patients 18 years of age and older with retinal angiomas due to VHL in one or both eyes and     central vision loss of 20/40 or worse may be eligible for this study. Participants will     undergo the following tests and procedures:        -  Medical history, physical examination, electrocardiogram (EKG) and blood tests.        -  Eye examination, including eye pressure measurement and dilation of the pupils to          examine the retina.        -  Fluorescein angiography to evaluate the eye's blood vessels. For this test, a yellow dye          is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of          the retina are taken using a camera that flashes a blue light into the eye. The pictures          will reveal if any dye has leaked from the vessels into the retina, indicating possible          blood vessel abnormality.        -  Optical coherence tomography to measure retinal thickness. The eyes are examined through          a machine that produces cross-sectional pictures of the retina. These measures are          repeated during the study to determine changes, if any, in retinal thickening.        -  Electroretinogram (ERG) to measure electrical responses generated from within the          retina. For this test, the patient sits in a dark room for 30 minutes with his or her          eyes patched. Then, a small silver disk electrode is taped to the forehead, the eye          patches are removed, the surface of the eye is numbed with eye drops, and contact lenses          are placed on the eyes. The patient looks inside an open white globe that emits a series          of light flashes for about 20 minutes. The contact lenses sense small electrical signals          generated by the retina when the light flashes.        -  Stereoscopic color fundus photography to examine the back of the eye. The pupils are          dilated with eye drops to examine and photograph the back of the eye.        -  EYE001 injections to treat ocular angiomas. Patients receive EYE001 injections through a          needle into the eye's vitreous (gel-like substance that fills the inside of the eye).          Six injections are given over a 30-week period. Before each injection, the surface of          the eye is numbed with anesthetic eye drops. This is followed by injection of another          anesthetic into the lower portion of they eye in the clear tissue surrounding the white          of the eye. After a few minutes, the EYE001 is injected into the vitreous. Patients          receive EYE001 injections at the first visit (during enrollment) and again at 6, 12, 18,          24, and 30 weeks after the first injection.      At each injection visit, participants repeat most of the tests described above to evaluate     the response to treatment and return a week later for another eye examination. After the last     injection, patients whose vision has improved may receive three more treatments at visits 36,     42, and 48. All participants will return for examinations at week 54 and at 2 months after     their final injection.   "
169436|NCT00056212|"     This study will compare the effectiveness of yoga classes, exercise classes, and a self-care     book in the management of pain and function for people with low back pain.   "
169437|NCT00056225|"     The purpose of this study is to determine whether reduction of homocysteine levels with     high-dose folate (folic acid), B6, and B12 supplementation will slow the rate of cognitive     decline in persons with Alzheimer's disease.   "
169438|NCT00056238|"     The main objective of this study is to evaluate the safety, tolerability and pharmacokinetics     of Cerebril™ in Cerebral Amyloid Angiopathy (CAA) patients who have had lobar cerebral     hemorrhage.   "
169439|NCT00056251|"     Patients with interstitial cystitis who meet eligibility requirements will be randomized to     one of four treatment arms (3 RTX, Placebo). Study drug is administered as a single     instillation within the urinary bladder. Study duration is 12 weeks.   "
169440|NCT00056264|"     The purpose of this study is to evaluate the safety and effectiveness of infliximab     (Remicade) in patients with Chronic Obstructive Pulmonary Disease (COPD). Infliximab     (Remicade) targets specific proteins in the body's immune system to help control the     development of inflammation to help reduce painful disease.   "
169441|NCT00056277|"     A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with     Bipolar Disorder   "
169442|NCT00056290|"     This gene therapy study is being conducted to evaluate intramuscular gene transfer using VEGF     (Vascular Endothelial Growth Factor) in patients with diabetic neuropathy in the legs. This     condition causes a decrease in feeling and sensation due to diabetes. VEGF is DNA, or genetic     material that is injected into the muscles of the leg. Once in the leg, it has been shown to     cause new blood vessels to grow under a variety of conditions.   "
169443|NCT00056303|"     This study will determine the effectiveness of a relationship-based intervention in improving     the interaction between caregivers and young children placed in their care.   "
169444|NCT00056316|"     The purpose of this study was to develop and examine the initial impact of a distance-based     intervention for female family dementia caregivers. As stated in the original proposal, the     primary hypothesis of the study was that family caregivers who participated in the Video     Intervention would show greater reduction in psychological distress (i.e., on measures of     depression and emotional distress following problematic patient behaviors) compared to those     in the Basic Education condition, and that this effect would be maintained over time (3 and 6     months post-tx).   "
169445|NCT00056329|"     The goal of this study is to determine the safety and efficacy of the administration of     vitamin E, which has been shown to delay the progression of Alzheimer's disease, in slowing     the rate of cognitive/functional decline in older persons with Down syndrome.   "
169446|NCT00056355|"     This study will examine the safety and effectiveness of extracorporeal photopheresis (ECP) in     controlling Crohn's disease symptoms as patients taper their corticosteroid dose. Crohn's     disease is a chronic inflammatory bowel disease. Patients commonly have chronic diarrhea with     abdominal pain, loss of appetite and weight loss. Acute disease flares are treated with large     doses of corticosteroids, but long-term use of these drugs can have harmful side effects. ECP     (described below), is approved to treat skin symptoms associated with a type of cancer called     cutaneous T-cell lymphoma and has been used experimentally in conditions involving abnormal     inflammation.      Patients 18 years of age and older who have had Crohn's disease for at least 6 months, who     are corticosteroid-dependent, and whose symptoms are controlled well enough so that their     Crohn's Disease Activity Index (CDAI) is less than 220, may be eligible for this study.     Candidates will be screened with a medical history and review of medical records, physical     examination, electrocardiogram, blood tests, urine pregnancy test for women of childbearing     potential, and a questionnaire about how Crohn's disease affects their life and activities.      Patients with a CDAI score of less than 150 will begin ECP treatments as soon as possible.     Those with scores from 150 to 219 will have their corticosteroid dose increased enough to     bring their CDAI score to below 150 before beginning ECP. Patients who do not achieve a CDAI     of less than 150 after 4 to 6 weeks of increased corticosteroids will be excluded from the     study.      Participants will have ECP treatments for 2 consecutive days every 2 weeks for 24 weeks, for     a total of 26 treatments. For ECP, patients undergo leukapheresis, a method of collecting     large numbers of white blood cells, or leukocytes-cells that may be responsible for many of     the medical problems in Crohn's disease. Whole blood is collected through a needle in an arm     vein, similar to donating a unit of blood. The blood flows through a machine that separates     it into its components by spinning. The white cells are removed and collected in a plastic     bag, and the red blood cells and plasma are returned to the patient's bloodstream through the     same needle. The collected white cells are mixed with a drug called UVADEX® (Registered     Trademark), exposed to ultraviolet (UVA) light, and then returned to the patients'     bloodstream. (The UVADEX allows the blood cells to absorb more UVA.) The UVA changes the     cells in a way that, once they are back in the body, they cause changes in other cells like     them. Each ECP treatment takes 3 to 4 hours. On the first day of each 2-day treatment,     patients will undergo a review of symptoms, check of vital signs, and blood draw. They will     complete a CDAI diary for 7 days before the first of the two ECP treatments and a     questionnaire about their life and activities at 4-week intervals. During the ECP treatment     period, corticosteroids will be slowly reduced as long as disease symptoms do not worsen.      Patients whose disease remains under control with cessation of all steroids may begin     maintenance ECP, 2 days in a row every 4 weeks for an additional 20 weeks (another 10     treatments), with the same follow-up as described above, and a full physical examination 4     weeks after the final treatment. Patients who were able to reduce, but not stop, steroid     treatment may be considered for maintenance therapy if it is thought that continuing     treatment may enable further reduction of steroids. Patients whose disease symptoms worsen     with ECP or who have not been able to decrease their steroid dose will not be eligible for     maintenance therapy and their participation in the study will end.   "
169447|NCT00056368|"     Anidulafungin is a medicine being developed for treatment of patients with certain kinds of     fungal infections. These infections due to yeast (a type of fungus) in the mouth/esophagus,     in the blood or in other areas within the body.   "
169448|NCT00056381|"     Anidulafungin is a medicine being developed for treatment of adults with certain kinds of     fungal infections. This study is evaluating anidulafungin in children and adolescents who     have fever and a low white blood cell count (neutropenia).   "
169521|NCT00057356|"     This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine     the effects of conivaptan in patients with acute decompensated heart failure.   "
169449|NCT00056394|"     Rheumatoid arthritis (RA) is the most common inflammatory arthritis and a major health     problem. Medical treatments are now being used much earlier in the course of RA, but these     treatments do not address the challenges of coping with the early stages of this disease.     This study will determine whether a comprehensive coping skills training program can decrease     pain, psychological disability, and physical disability in patients with early RA.   "
169450|NCT00056407|"     This 4-year study will compare how safe and effective an oral investigational medicine is     (compared to placebo) in preventing the development of prostate cancer in men that are     defined by the study entrance criteria as being at an increased risk for prostate cancer.     Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits),     and a prostate biopsy will be performed at 2 and 4 years of treatment.   "
169451|NCT00056420|"     This study will use electroencephalography (EEG) and electromyography (EMG) to examine how     the brain generates tics and controls voluntary movement in patients with Tourette's syndrome     and chronic motor tic disorder. EEG records the electrical activity of the brain. For this     test, a cap with built-in electrodes is placed on the subject's head, and the electrodes are     connected to a monitor that records the brain activity. EMG records muscle activity using     electrodes placed on the skin over muscles on the fingers or above the outer corner of the     eyes.      Healthy normal volunteers and patients with Tourette's syndrome and chronic motor tic     disorder between 21 and 65 years of age may be eligible for this 2- to 3-hour study. Each     candidate will be screened with a medical history, physical and neurological examinations,     and a questionnaire that screens for psychiatric disorders.      During EEG and EMG recordings, participants undergo the following tasks while seated     comfortably in a sound-shielded room:      Patients        -  Finger task: Patients raise their index finger once every 10 seconds for about 25          minutes.        -  Tic evaluation and mimicking: Patients allow their tics to occur as they do naturally.          After each tic, they report whether the tic was voluntary and whether it was preceded by          a sensation of urge. They then mimic tics that they normally have, at a rate of about          once every 10 seconds.        -  Tic suppression task: Patients suppress tics they normally have for several minutes.          They then allow the tics to occur naturally, without attempting to suppress them.      Normal Volunteers        -  Finger task: Volunteers raise their index finger once every 10 seconds for about 25          minutes.        -  Open eye task: Volunteers keep their eyes open for a minute or so, and then resume          blinking as often as feels comfortable. The process is repeated several times.   "
169471|NCT00056693|"     To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.   "
169452|NCT00056433|"     Patients with sickle cell disease have abnormal hemoglobin (the protein in red blood cells     that carries oxygen to the body). This abnormality causes red blood cells to take on a sickle     shape, producing disease symptoms. Fetal hemoglobin, a type of hemoglobin present in fetuses     and babies, can prevent red cells from sickling. The drug hydroxyurea increases fetal     hemoglobin production in patients with sickle cell disease by making a molecule called nitric     oxide. The drugs L-arginine and Sildenafil (Viagra) increase the amount or the effect of     nitric oxide. This study will evaluate:        -  The safety of giving L-arginine or Sildenafil together with hydroxyurea in patients with          sickle cell disease;        -  The effectiveness of L-arginine plus hydroxyurea or Sildenafil plus hydroxyurea in          increasing fetal hemoglobin in patients with sickle cell disease; and        -  The effectiveness of L-arginine plus hydroxyurea or Sildenafil and hydroxyurea in          lowering blood pressure in the lungs of patients with sickle cell disease. (Pulmonary          blood pressure is elevated in about one-third of patients with sickle cell disease, and          this condition increases the risk of dying from the disease.)      Patients with hemoglobin S-only, S-beta-thalassemia, or other sickle cell disease genotype     may be eligible for this study.      Before starting treatment, patients will have a complete medical history and physical     examination. All patients will take hydroxyurea once a day every day by mouth for at least 2     months. They will be admitted to the NIH Clinical Center to take their first dose of     hydroxyurea, and will have blood drawn through a catheter (plastic tube placed in a vein)     every hour for 6 hours for tests to determine nitric oxide levels. After discharge, they will     return to the clinic once every 2 weeks to check for treatment side effects and for blood     tests to monitor hemoglobin and fetal hemoglobin levels. After fetal hemoglobin levels have     been stable for 2 months, patients will be admitted to the Clinical Center for their first     dose of L-arginine (for men) or Sildenafil (for women). Again, blood samples will be     collected through a catheter once an hour for 6 hours. If there are no complications,     patients will be discharged and will continue taking hydroxyurea once a day and L-arginine or     Sildenafil three times a day for at least 3 months until fetal hemoglobin levels have been     stable for at least 2 months. Patients will return to the clinic for blood tests every week     for 2 weeks and then every 2 weeks to monitor hemoglobin and fetal hemoglobin levels and to     check for treatment side effects.      Patients will have eye examinations before and during treatment. Some patients with sickle     cell disease develop abnormalities in the blood vessels of the eye. Also, Sildenafil can     cause temporary changes in color vision. Rarely, more serious eye problems can occur, such as     bleeding from the eye blood vessels or damage to the retina a layer of tissue that lines the     back of the eye. Patients will also have an echocardiogram (ultrasound of the heart) before     beginning treatment, after hydroxyurea treatment, and after 1 and 3 months of combined     treatment with hydroxyurea and L-arginine or Sildenafil to help measure blood pressure in the     lungs.      Patients who develop complications from L-arginine or Sildenafil may continue in the study on     hydroxyurea alone. Patients whose fetal hemoglobin levels increase with the combination     therapy of hydroxyurea and L-arginine or Sildenafil may continue to take them.   "
169453|NCT00056446|"     The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus     vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer     that has spread to other organs and whose disease has worsened after treatment with     irinotecan.   "
169454|NCT00056459|"     To compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus     oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread     to other organs and are seeking first chemotherapy treatment   "
169455|NCT00056472|"     This study will determine the effectiveness of combining selective serotonin reuptake     inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.   "
169456|NCT00056485|"     This study will implement a treatment for depression in a nursing home setting.   "
169457|NCT00056498|"     This study will determine whether adding the drug risperidone (Risperdal®) is more effective     than placebo in treating schizophrenic patients who are taking the drug clozapine.   "
169458|NCT00056511|"     The purpose of this study is to determine whether fresh garlic can positively affect     cholesterol in adults with moderately high cholesterol levels. This study will also determine     whether the same effects can be found for two main types of garlic supplements: a dried     powdered garlic (designed to yield the same effect as fresh garlic) and an aged garlic     extract preparation.   "
169459|NCT00056524|"     The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of     Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes     of uncontrolled crying and/or laughter).   "
169460|NCT00056537|"     The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one     that triggers an attack on the tumor cells by activating some white blood cells belonging to     the body's normal immune system. In animals, this results in an accumulation of white blood     cells in the cancer that can fight the cancer. This study will test how much of the drug can     be given to patients with non-small cell lung cancer, renal clear cell carcinoma, or     pancreatic cancer without causing unacceptable side effects.   "
169461|NCT00056550|"     Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous     thrombosis and pulmonary embolism, particularly during certain high risk procedures. The     trial is focusing on patients with confirmed hereditary antithrombin deficiency who are     undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will     test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior     to, during and following the period of risk or surgical procedure.   "
169462|NCT00056563|"     The goals of this study are to determine if simultaneous bilateral subthalamic nucleus     stimulation or simultaneous bilateral globus pallidus stimulation is more effective in     reducing symptoms of Parkinson's disease, and if deep brain stimulation or best medical     therapy is more effective in improving Parkinson's disease symptoms   "
169463|NCT00056576|"     The purpose of this study is to determine whether zonisamide alone is effective as a     treatment for epilepsy in newly diagnosed cases.   "
169465|NCT00056602|"     This study will explore how patients with rheumatoid arthritis evaluate, or rate, symptom     improvements. Physicians generally evaluate patients health and treatment benefits based on     laboratory measures, such as the number of tender or swollen joints, duration of morning     stiffness, grip strength, pain severity and others. Less attention is given to whether these     treatment results are meaningful to patients. This study will examine how much of an     improvement in pain, stiffness, function, and other symptoms is needed before patients     consider the change an important improvement.      Patients 18 years of age or older who were diagnosed with rheumatoid arthritis after age 16     and who have active arthritis (6 or more tender joints) may be eligible for this study. Of     particular interest are patients beginning treatment with prednisone, methotrexate,     leflunomide, infliximab, or etanercept, although patients receiving any type of treatment may     be included.      Participants will be evaluated twice at the NIH Clinical Center, once at the start of the     study and again at either 1 month or 4 months later, depending on the individual s treatment     regimen. Permission will also be requested to review patients medical records for results of     previous blood tests and x-rays. At each NIH visit, patients will undergo the following tests     and procedures:        -  Medical history and physical examination, including evaluation of joint swelling and          tenderness;        -  Questionnaires about rheumatoid arthritis symptoms;        -  Computer-based exercise to assess preferences for various state-of-health choices;        -  Grip strength test;        -  Walking test on level ground, with or without the use of a cane or walker;        -  Blood test to measure inflammation.      At the second visit, in addition to the above procedures, participants will complete a     questionnaire to rate the importance of changes, if any, in pain, morning stiffness, fatigue,     joint swelling, functioning, worry, depression, and overall impressions, since the first     visit.   "
169466|NCT00056628|"     This is a study of the effect on the progression of Alzheimer's Disease of a surgically     implanted shunt (tube) to increase the flow of cerebrospinal fluid and improve the clearance     of potential neurotoxins from the fluid bathing the brain.   "
169468|NCT00056654|"     The primary purpose of the study is to determine if a new sustained-release 45 mg (depot)     formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them     at medically castrate levels in subjects with prostatic adenocarcinoma.   "
180398|NCT00186264|"     The primary purpose of this study is to examine whether IV hydrocortisone can speed up the     time required for Venlafaxine XR to work.   "
169472|NCT00056706|"     This study will determine whether impaired hand function due to stroke can be improved by     blocking nerve impulses to the unaffected arm. Following a stroke, the unaffected side of the     brain might negatively influence the affected side. Studies in healthy volunteers show that     function in one hand improves when ischemic nerve block (inflating a pressure cuff to block     nerve impulses) is applied to the forearm of the other hand. This study will examine whether     similar improvement also occurs in the affected hand of patients with chronic impairment     after stroke.      Stroke patients with sensory (numbness) or motor impairment (weakness) in the hand that has     persisted at least 12 months after the stroke may be eligible for this study. Patients who     have had more than one stroke, whose stroke affected both sides of the body, who have a     history of deep vein thrombosis (blood clotting), or who are receiving anticoagulant     (blood-thinning) treatment at the time of the study will not be enrolled.      Participants will have physical and neurological examinations and will undergo the following     procedures:      Session 1        -  Magnetic resonance imaging (if one has not been done within the previous 6 months): MRI          uses a magnetic field and radio waves to produce images of body tissues and organs. For          this procedure, the patient lies on a table that is moved into the scanner (a narrow          cylinder) and wears earplugs to muffle loud knocking and thumping sounds that occur          during the scanning process. The procedure lasts about 45 to 90 minutes, during which          the patient lies still up to a few minutes at a time.        -  Mini Mental State Examination - Patients will take a short test to assess cognitive          function.      Sessions 2 (and possibly 3 and 4)        -  Motor task practice: Patients practice a motor task several times to achieve optimal          performance. The task is a rhythmic, repetitive pinch grip at maximal strength at a          frequency of one grip every 10 seconds. If technical difficulties arise during the          session, the procedure will be repeated in sessions 3 and 4.      Sessions 5 (and possibly 6)        -  Pinch grip and ischemic nerve block (INB): Patients perform the pinch grip task several          times and then INB is applied. For INB, a blood pressure cuff is inflated around the arm          at the level of the elbow for 35 to 50 minutes. The procedure causes temporary numbness,          tingling, loss of muscle strength, and discoloration or the forearm and hand. Patients          repeat the pinch grip task during the INB and again 20 minutes after the INB is          released. If technical difficulties arise during the session, the procedure will be          repeated in session 6.      Session 7      This session is identical to session 5, except the INB is applied immediately above the ankle     instead of on the forearm.   "
169473|NCT00056719|"     This study will explore how genes may influence the severity of ankylosing spondylitis, a     form of arthritis that affects the spine. Patients have inflammation of the joints of the     spine, which may cause the bones of the spine to fuse, resulting in difficulty performing     daily activities.      Patients who developed ankylosing spondylitis after age 16 may be eligible for this study.     The onset of disease is dated to the first appearance of symptoms of inflammatory low back     pain or restricted spinal motion. Patients with a spondyloarthropathy other than AS may not     participate. Candidates will be screened with a medical history and physical examination,     blood test, and review of their medical records. They will also complete a questionnaire     about their disease symptoms and medical history.      Those enrolled in the study will return to the NIH Clinical Center at 6, 12, 18, 24, 30, 36,     42, 48, 54, and 60 months after screening for examination of the joints, measurement of     flexibility of the spine, and a blood test. They will also complete symptoms assessment and     coping questionnaires. At the first study visit (screening visit), x-rays will be taken of     the pelvis, lower back, and neck, if recent X-rays (within 1 year) are not available. These     x-ray studies will be repeated on all patients every two years during the study (at 24 and 48     months after screening).   "
169474|NCT00056745|"     The purpose of this study is to determine the safety and immune system response to the TBC-3B     HIV vaccine when it is injected either into the groin area or into the arm. The goal is to     determine which injection site is better at producing a particular type of immune response.     This study is not evaluating the effectiveness of the vaccine, so volunteers must maintain     low risk behavior for HIV transmission throughout the study.   "
169475|NCT00056758|"     This study will evaluate the safety of and immune responses to a dendritic cell vaccination     for HIV-1 infection. The vaccine will be made from a patient's own cells combined with small     fragments of HIV-1 (made synthetically in a laboratory). These cells will be administered     back to the patient either into a vein (intravenously) or the skin (subcutaneously).   "
169476|NCT00056771|"     This study will explore the clinical and hereditary (genetic) features of inherited     cataracts. A cataract is a clouding of the eye lens, which focuses light on the back of the     eye. When the lens becomes cloudy and does not let light through, vision is impaired.     Cataracts may be associated with vision problems alone, or with other problems, such as     changes in facial appearance or skin problems. A better understanding of these genetic     conditions may help in the development of better diagnostic tests.      Patients with inherited cataracts and their family members may be eligible for this study.     Participants will be drawn from patients enrolled in other studies of inherited cataracts at     the NEI and collaborating clinics.      Participants will undergo the following tests and procedures:        -  Medical and surgical history;        -  Verification of diagnosis;        -  Construction of a family tree regarding familial vision problems;        -  Complete eye examination, including dilation of the pupils and photography of the lens,          tests of color vision and field of vision, and of the ability to see in the dark;        -  Blood sample collection (20 ml, or 4 teaspoons) for genetic studies of hereditary          cataracts.   "
169477|NCT00056784|"     This study will examine whether measurements of connective tissue growth factor (CTGF) and     other cell proteins can identify which kidney transplant recipients are likely to develop     chronic allograft nephropathy (CAN), a disease of the transplanted kidney. CAN may occur     months to years after the transplant. The kidney becomes progressively scarred and eventually     loses all function, so that dialysis or another transplant is needed. A better understanding     of how CTGF and other proteins are involved in the development of CAN may provide new targets     for treating for the disease.      Patients who are scheduled to receive a kidney or combined kidney-pancreas transplant or who     have received a transplant recently (within 6 months) may be eligible for this study.     Participants will be enrolled before the transplant, if possible, or after the transplant,     and will undergo the following tests and procedures:        -  Physical examinations at the screening visit, at 1, 6, 12, and 24 months, and then once          yearly.        -  Blood sample collections at the screening visit, at 1, 6, 12, 18, and 24 months and then          once yearly.        -  Urine sample collections at the screening visit, at 1, 6, 12, 18, and 24 months and then          once yearly.        -  Kidney biopsies at the beginning of the study, at 1, 6, 12, and 24 months, and then once          a year for research purposes. Participants may refuse to have a research biopsy at any          time during the study. Also, patients who are having a kidney biopsy for another reason          at these time points will not have a second biopsy. The biopsy procedure takes about 15          minutes and is done in the hospital. The patient lies on his or her back and the skin          over the transplanted kidney is cleaned with alcohol and iodine. The area is numbed with          an injection of an anesthetic, and then a biopsy needle is placed through the kin. The          biopsy may be repeated up to three times to get enough tissue to test for CAN. Patients          lie flat for 4 hours after the procedure to reduce the risk of bleeding, and are          observed for another 2 hours for possible complications.   "
169478|NCT00056797|"     This study will evaluate whether the HIV vaccine ALVAC vCP1452 given in combination with     interleukin-2 (IL-2), also known as aldesleukin, can increase immune system function in     people with HIV infection.   "
169528|NCT00057447|"     Evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b     (IFN g-1b) administered 3 times per week with Rituximab for 4 weeks, in patients with     progressive or relapsed low-grade Non-Hodgkin's Lymphoma (NHL)      International study with sites in the Czech Republic and Poland   "
169820|NCT00061126|"     A clinical trial examining the safety and effectiveness of ABX-EGF when given to patients     with prostate cancer with or without tumor in other parts of the body.      Patients will be treated for a maximum of 48 doses (6 treatment courses; 8 doses per course)     or until evidence of progressive disease.   "
169479|NCT00056810|"     In developed countries, Guillain-Barre Syndrome (GBS) is the most common cause of acute     neuromuscular paralysis, afflicting about 5,000 persons annually in the United States. Over     20% of GBS patients have permanent residual motor deficits that affect their activities of     daily living.      The goal of this study is to assess the potential usefulness and safety of 4-aminopyridine     (4-AP) in those patients who suffer chronic functional deficits from GBS.This medication is a     potassium channel blocker that has the potential to improve nerve conduction, particularly     across partially demyelinated axons. It is felt that by increasing nerve conduction there     will be improved motor performance for walking and activities of daily living, as well as     decreased fatiguability. This medication has demonstrated potential usefulness in central     demyelinating diseases such as multiple sclerosis.Because the peripheral nervous system is     much more accessible to systemic medication delivery it is felt that this medication may     improve the functional status of those patients who are suffering from the residual side     effects of this medication.   "
169480|NCT00056823|"     The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in     combination with verteporfin photodynamic therapy (PDT) is a safe and efficacious treatment     for patients with age-related macular degeneration.   "
169481|NCT00056836|"     The purpose of this study is to determine whether injections of rhuFab V2 into the eye can     prevent vision loss in patients with age-related macular degeneration, and also to evaluate     the safety of this treatment.   "
169482|NCT00056849|"     This study will explore how genes-units of heredity-may influence the severity of ankylosing     spondylitis. It will examine whether some genes may cause people with ankylosing spondylitis     to have more rapid fusion of the bones of the spine, more difficulty performing daily     activities, or be more likely to need joint surgery.      Patients who developed ankylosing spondylitis after age 16 and have had the disease for 20     years or more may be eligible for this study. The onset of disease is dated to the first     appearance of symptoms of inflammatory low back pain or restricted spinal motion. Patients     with a spondyloarthropathy other than AS may not enroll.      Participants will complete a brief medical history and physical exam. They will fill out a     30-minute questionnaire that includes questions on demographics (such as age, ethnicity,     marital status, etc.), medication history, work history, hip surgeries, and assessment of     functional disability. Fifty milliliters (about 3-1/3 tablespoons) of blood will be drawn for     gene testing, and X-rays will be taken of the pelvis, lower back, and neck, if recent X-rays     (within 1 year) are not available. Women of childbearing age will have a urine pregnancy test     before having X-rays.   "
169483|NCT00056862|"     This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for     certain patients with chronic hepatitis C-a liver disease that, in some patients, can     progress to cirrhosis of the liver, liver cancer, and liver failure.   "
169484|NCT00056875|"     This is a single arm dose escalation study of recombinant human keratinocyte growth factor     given to patients undergoing allogeneic bone marrow transplantation who are at high risk for     graft versus host disease (GVHD).   "
169499|NCT00057070|"     The adverse impact of tobacco use on disease prevalence and health care costs is well     documented. Hence, finding effective ways to reduce tobacco dependence is an essential     component of improving the outcomes, quality and efficiency of VHA care. The U.S. Public     Health Service (PHS) Smoking Cessation Clinical Practice Guideline provides specific     recommendations for treating tobacco dependence. Despite their strong evidence base, however,     these recommendations have not been fully integrated into clinical practice within the VHA.     Recent data suggest that logistical difficulties associated with identifying and linking     smokers with appropriate treatments may explain why the PHS Smoking Cessation Guideline has     not been more broadly implemented.   "
169500|NCT00057083|"     The purpose of this study is to determine whether the physical separation between patient and     physician required during telemedicine has an affect on physician-patient communication and     related outcomes, including patient and physician satisfaction, patient compliance, and     patient understanding of medical care.   "
169485|NCT00056888|"     This study will use three neurophysiological tests (see below) to determine what areas of the     brain are responsible for paroxysmal hyperkinetic movement disorders. Patients with these     disorders have sudden, brief attacks of movement, similar to epileptic seizures, but without     loss of consciousness.      Normal volunteers and patients with two subtypes of paroxysmal hyperkinetic movement     disorder, paroxysmal dyskinesia and psychogenic variant, that can be induced by a specific     trigger, such as a sudden movement or prolonged exercise, will be included in this study.     Candidates must be 12 years of age or older. Women of childbearing potential will be screened     with a pregnancy test.      Participants will undergo one or more of the procedures detailed below. Patients' test     results will be compared with those of normal volunteers. Before each test, participants will     provide a medical history and undergo a brief physical examination. During each procedure,     the subject will have surface electromyography (EMG) to measure the electrical activity of     muscles. For EMG, electrodes (metal discs) filled with a conductive gel are taped to the skin     over the muscle to be evaluated.      Functional Magnetic Resonance Imaging (fMRI)      MRI uses a strong magnetic field, radio waves, and computer technology to provide detailed     images of the brain. For this test, the subject lies in a narrow cylinder (the scanner),     while pictures of the brain are taken. Earplugs are worn to muffle loud noises caused by     electrical switching of radio frequency circuits used in the scanning process. For functional     MRI (fMRI), the subject is asked to mimic a movement that occurs during an attack, such as     stiffening the hand to make a fist or flexing and rotating the arm inward, to detect changes     in the brain regions involved in the movement. During the procedure, involuntary movements     and voluntary movements will be monitored by surface EMG and by video camera. The test will     last about 1-1/2 hours.      Electroencephalography (EEG)      EEG measures the electrical activity of the brain (brain waves) with electrodes placed on the     scalp. During the procedure, muscle activity will be recorded with EMG. The subject will     first relax and then will be asked to mimic a movement attack. The test will last from 1-1/2     to 2 hours.      Startle Reflex      The subject will put on a headphone and hear loud noises in a random fashion. During the     test, muscle activity will be recorded with EMG and with a video c...   "
169505|NCT00057148|"     Postoperative pain is often undertreated. Although studies have demonstrated that many     patients experience a substantial degree of unrelieved pain following operative procedures     and that this pain can increase the incidence of serious complications, the management of     discomfort continues to be suboptimal. Narcotic analgesia is the mainstay of acute     postoperative pain management but patient, clinician, and institutional barriers often limit     the effectiveness of drug treatment. Furthermore, pharmacologic interventions alone may not     address all the factors involved in the conscious experience of pain. Massage is a     complementary or adjunctive medical technique that has been used for thousands of years. Yet     there is scant research related to the use of massage therapy in postoperative pain     management. Used in tandem with pharmacologic treatments, massage may have the potential to     substantially improve acute pain relief.   "
170705|NCT00072618|"     The purpose of this study is to determine if the combination of Taxotere and exisulind is an     effective and safe treatment for patients with advanced NSCLC who have failed a prior     platinum-containing regimen.   "
169486|NCT00056901|"     This study evaluates the relationship between mood changes and hormones in women with     postpartum depression (PPD).      This is an observational study; volunteers who participate will not receive any new or     experimental therapies.      PPD is similar to major depression, but develops around the time a woman gives birth. Women     with PPD often suffer serious physical and emotional impairments. Controversy exists     regarding the role of hormone changes in postpartum depression. This study will examine the     role of hormone changes in three groups of women: those who recently gave birth and have mild     to moderately severe PDD (Group 1), women who recently gave birth and do not have PDD (Group     2), and those who are currently pregnant and experienced an episode of PDD with a previous     birth (Group 3).      Participants will be screened with a medical history, physical examination, and blood and     urine tests. Upon study entry, they will be interviewed about their moods, behaviors, and     medical status during and immediately following their last pregnancy. Some women will be     asked to participate in interviews, psychological tests, and blood tests. They will also     complete self-rating scales and may be asked to collect samples of their urine. Women in     Group 3 will complete self-rating scales for 6 months postpartum. Participants will     participate in genetic studies that involve completing a questionnaire and providing a blood     sample. If the participant allows, sisters and parents may be asked to provide a blood sample     and undergo a psychiatric interview.      Participants who meet the criteria for minor depression or major depression that is no     greater than moderate severity will be asked to participate in a companion study that will     evaluate the effectiveness of estradiol in reducing depression symptoms.   "
169487|NCT00056914|"     This study will develop new techniques for optimizing resolution in magnetic resonance     imaging (MRI) with a high magnetic field of 7 Tesla. MRI is a diagnostic tool that generates     high-quality images of the body without the use of x-rays. It can also provide information     about brain chemistry and physiology. The test is routinely done at magnetic field strengths     of from 1.5 to 4 Tesla. This study will use an investigational device that operates at a high     magnetic field of 7 Tesla. Except for the increase in magnetic field, all other aspects of     imaging are the same as those at lower magnetic fields. This study will use techniques in     conjunction with the higher magnetic field that may improve diagnostic imaging. The MRI will     monitor the brain at high resolution to see structural features, to measure brain chemicals,     and to determine how much and how fast blood flows into brain regions in response to simple     tasks.      Healthy normal volunteers 18 years of age and older may participate in this study. Candidates     will be screened with a medical history, neurological examination, and questionnaire.      Participants will have a standard 1.5 or 3 Tesla MRI before the 7 Tesla scan, adding about 5     minutes to the procedure. The procedure for both scans is the same. The subject lies on a     table that is moved into the scanner. Because the machine makes loud sounds during the     imaging, earplugs are provided to help reduce the noise. An insulated wire coil may be placed     around the subject's head to obtain better images. Scanning time varies from 20 minutes to 3     hours, with most examinations lasting between 45 and 90 minutes. During the scan, the subject     may be asked to perform simple tasks, such as listening to tones, tapping fingers, moving a     hand, watching a movie on a screen, or smelling pleasant odors. More complex tasks may     require thinking about tones or pictures and responding to them by pressing buttons.     Following the test, subjects will complete a brief questionnaire about comfort level and any     unusual sensations they may have experienced during the test.      Participants who undergo repeated MRIs for the evaluation of new techniques will have a     standard 1.5 or 3 Tesla MRI brain study once a year while participating in the research     protocol. A radiologist at NIH will read the MRIs, and if any abnormalities are discovered,     the individual will be referred to his or her private physician or to a consult service at     NIH.   "
169488|NCT00056927|"     The purpose of this study is to determine whether an anti-smoking program for parents who     smoke will lower the odds that their children will start smoking. The study will evaluate an     activity-based program for parents and their children. The program is home-based and uses the     mail for program delivery.   "
169489|NCT00056940|"     Violence is one of the major causes of death and injury for children, adolescents, and young     adults 10 to 25 years of age. This study will examine the effectiveness of a violence     prevention program in pediatricians’ offices. The program is designed for families who bring     their 2 to 11 year old children in for a well child exam. It focuses on helping parents     change behaviors related to the development of violent behavior in children.   "
169490|NCT00056953|"     This study will evaluate the effectiveness of a peer mentoring program designed for youths     ages 9 to 15 whose parents or guardians are HIV infected. The program will focus on the     youths' mental health, school performance, alcohol and drug use, personal and social     behaviors, and behaviors that might expose them to HIV. The study is expected to enroll     predominantly minority youth.   "
169501|NCT00057096|"     Veterans presenting for treatment of substance use disorders (SUDs) often have multiple and     serious comorbid medical conditions that affect functional health status and health care     costs. Prior studies show higher rates of medical follow-up when onsite primary health care     was provided to patients with SUDs within an addictions clinic (onsite care). However, no     data are available on differences between onsite versus referral models of primary care     delivery in terms of clinical outcomes and total health care costs.   "
169502|NCT00057109|"     We have previously shown that: 1) time tradeoff utilities for current health are high,     indicating that patients have a strong will to live; 2) half of patients felt that their life     was better now than before they were HIV-infected; and 3) certain non-health-related factors     such as spirituality and concern and love for one�s children correlated with health values     and a sense that life has improved.   "
169506|NCT00057161|"     Money management is a neglected issue in maintaining persons with mental illness in the     community. This randomized controlled trial (RCT) assessed whether a community-based     representative payee program, i.e., money management of Social Security and/or VA benefits,     coordinated with VA psychiatric care (CO-RP) could be more effective than customary treatment     for veterans who had no representative payee.   "
169507|NCT00057174|"     This is a series of two prospective studies based on the Department of Veterans Affairs drug     treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Our     hypothesis is that novel strategies for medical management of gastroesophageal reflux disease     (GERD) can decrease resource utilization without adversely affecting patient quality of life.     The strategies tested in this project included 1) step-down management, whereby patients     rendered asymptomatic on proton pump inhibitors (PPIs) are treated with less expensive     medication, and 2) intermittent therapy, defined as administration of medication only for     recurrence of GERD symptoms. We chose to examine an intermittent strategy of PPI     administration since in addition to the VA guideline requiring step-down therapy,     over-the-counter PPIs administered by intermittent therapy became available for use by     patients during the study period.   "
169508|NCT00057187|"     Although substance abuse treatment continuing care participation is strongly related to     positive treatment outcomes, participation rates are low and few interventions have been     developed that improve continuing care adherence and outcome.   "
169491|NCT00056966|"     Participants in this study have a hematologic malignancy (a disorder in the bone marrow that     affects the body's ability to create blood) that might benefit from receiving an allogeneic     stem cell transplant (meaning the cells come from a donor) from a family member or nearly     identical matched donor. The donor may either be a matched sibling, a mismatched family     member, or an unrelated person.      Usually these patients are given high doses of chemotherapy before receiving a stem cell     transplant to keep their immune system from rejecting the donor stem cells and to kill any     diseased cells that remain in the body. However, this group of patients have a high risk of     developing possibly life-threatening treatment-related side effects such as infections,     damage to vital organs such as lungs, liver, kidney and heart, as well as graft versus host     disease (GVHD).      Instead of the high dose chemotherapy and radiotherapy usually given before a transplant,     this research study uses a new pre-transplant combination of three drugs, Fludarabine,     Anti-CD45 and CAMPATH-1H with low dose radiotherapy. Fludarabine is a chemotherapy drug while     Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells, including those     which are causing this disease. CAMPATH-1H is particularly important because it stays active     in the body for a long time after it is given, which means it may work longer to prevent GVHD     symptoms. Anti-CD45 may help in eradicating residual malignant cells. All these agents also     help in preventing rejection of donor stem cells. This study is designed to give a less     intense chemotherapy and radiotherapy, so that the life-threatening toxicities of     conventional high dose chemotherapy and radiotherapy regimen can be reduced, while     maintaining the ability to cure cancer.   "
169492|NCT00056979|"     This study treats patients with an inherited disease that prevents the body from making a     specific protein or enzyme needed for the body's metabolism. Lack of this enzyme causes     accumulation of harmful or toxic substances in the body, which leads to deterioration and     failure of organs such as the brain or the heart. This disease can be fatal.      Some patients with inherited metabolic storage disease may benefit from an allogeneic stem     cell transplant ('allogeneic' means that the stem cells come from another person). Stem cells     are created in the bone marrow. They mature into different types of blood cells that are     needed including red blood cells, white blood cells, and platelets. Stem cells, when     transplanted, can make a new blood system. Donor stem cells can make the protein or enzyme     patients with this disease cells cannot. The donor cells may prevent further accumulation of     toxic substances. It is hoped that the donor cells can prevent or stop the disease from     progressing.      This research study uses a new pre-treatment combination of two drugs, Anti-CD45 and     CAMPATH-1H. Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells.     CAMPATH-1H is particularly important because it stays active in the body for a long time     after infusion, which means it may work longer at preventing GVHD symptoms. In addition to     antibodies, patients will receive Fludarabine, which is a chemotherapy drug. Fludarabine     kills bone marrow cells and is given to reduce the bone marrow cells so that donor stem cells     may 'take.'   "
169493|NCT00056992|"     Amino acid deprivation therapy is an effective means for the treatment of some forms of     cancer. Recently it has been found that human hepatocellular carcinomas (HCC) cell lines     appear to require arginine for growth. Arginine is not an essential amino acid for human     adults or infants as it can be synthesized from citrulline (for review see Rogers 1994).     Therefore, selective elimination of arginine from the circulation may be a means of treating     patients with metastatic melanoma or non resectable HCC.      The enzyme arginine deiminase (ADI) metabolizes arginine into citrulline (Cunin 1986).     However, ADI is only found in microbes and not in humans. ADI is therefore, highly     immunogenic and has a short serum half-life following injection. These potential drawbacks     (microbial source and thus viewed as foreign by the human immune system, and a short serum     half-life) can be overcome by covalent attachment of polyethylene glycol (PEG) to     argininedeiminase and termed this drug ADI-PEG 20.      ADI-PEG 20 appears to be an effective anti-cancer treatment for human HCC. Pharmacokinetic     and pharmacodynamic data indicates a once a week injection of 160 IU/m2 of ADI-PEG 20     eliminates all detectable arginine from the circulation for at least 7 days. This treatment     appears to be well tolerated. The purpose of this study is to determine the efficacy of this     treatment in patients with HCC. Efficacy is a primary end point of this study. No patients     will recieve placebo.   "
169494|NCT00057005|"     Participants in this study have a hematologic malignancy which is a disorder in the bone     marrow that affects the body's ability to create blood. Participants might benefit from     receiving an allogeneic stem cell transplant (meaning the cells come from a donor). The     participants donor is a family member. Stem cells are cells in the bone marrow and blood that     can form a whole new blood system.   "
169495|NCT00057018|"     An individual suffering a stroke or other brain injury may lose function on one side of the     body (partial paralysis). As the individual shifts activities to favor the unaffected side,     the problem worsens. Constraint induced (CI) therapy forces the individual to use the     neglected arm by restraining the good arm in a sling. This study examines the effectiveness     of CI therapy for improving arm motion after stroke.   "
169496|NCT00057031|"     The purpose of this study is to determine the safety and efficacy of DN-101 (calcitriol) in     patients with myelodysplastic syndrome who are dependent on repeat blood transfusions.   "
169497|NCT00057044|"     The overall purpose of this project is to improve the clinical outcomes of veterans with     ischemic heart disease (IHD) through implementation of evidence-based lipid management, with     a particular focus on veterans whose primary lipid abnormality is a low level of     HDL-cholesterol (the �good� cholesterol).   "
169498|NCT00057057|"     In addition to medical treatment for heart failure (HF), a variety of non-pharmacological     interventions have been demonstrated to benefit these patients. Some of these include systems     for weight monitoring and medication reminders, exercise programs, and individually tailored     evaluation and treatment plans with dietitians, social workers, psychologists, and nurse case     managers. While many of these approaches have been shown to increase adherence to medication     guidelines and result in decreased health care utilization, most rely heavily on a large team     of specialized health care providers. It remains unknown whether or not an intervention with     a lower intensity of specialized care using sophisticated automated computer tracking and     Interactive Voice Response (IVR) techniques can impact the care of HF patients.   "
173537|NCT00115336|"     The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory     drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis     of sickle cell disease (SCD).   "
169509|NCT00057200|"     Congestive heart failure (CHF) is one of the most common reasons for hospitalization in     patients aged 65 years and older. Many hospitalizations for CHF are potentially preventable     if the warning signs of decompensation are recognized and treated before the situation     becomes emergent. Home-based intervention programs have reduced unplanned readmission rates     for patients with CHF by up to 50 percent. Using advanced telecommunications technologies it     is now possible to provide greatly improved access and availability of services in a more     timely and cost effective manner directly to patients� homes. Although telehealth offers a     number of theoretical advantages, few empirical studies have compared telehealth to     traditional delivery modes, and virtually no studies have compared the effectiveness of     alternative telehealth applications.   "
169510|NCT00057213|"     A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in     Patients with Major Depressive Disorder (MDD)   "
169511|NCT00057226|"     A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in     Patients with Major Depressive Disorder (MDD)   "
169512|NCT00057239|"     A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Radafaxine in     Patients with Major Depressive Disorder (MDD)   "
169513|NCT00057252|"     This study will develop and evaluate new techniques for computer-aided detection and     diagnosis (CAD) of medical problems using images from diagnostic tests such as computed     tomography (CT), ultrasound, nuclear medicine and x-ray images. The Food and Drug     Administration has approved CAD techniques for detecting masses and calcifications on     mammography and lung nodules using chest x-rays. Many other applications of CAD would     potentially benefit patients. This study will explore additional uses of CAD.      The study will use imaging data, demographic information, and other medical information from     the medical charts of Clinical Center patients to test and evaluate new CAD applications.     Such applications include detection of subcutaneous (under the skin) lesions in melanoma     patients, bone lesions in patients with advanced cancer, and pulmonary emboli (blood clot     lodged in a lung artery) in patients who are known to have pulmonary emboli, and other uses.   "
169514|NCT00057265|"     This study is being conducted to compare the safety and effectiveness of the investigational     medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European     and Asian Health Authorities for the treatment of hepatitis B infection. The results for     patients taking LdT will be compared to results for patients taking Lamivudine.   "
169515|NCT00057278|"     This study will assess the safety and effectiveness of the drug gabapentin in reducing pain     associated with primary fibromyalgia.   "
169516|NCT00057291|"     This study evaluates the effect on children and caregivers of providing training in warm,     sensitive, responsive caregiving to caregivers in three orphanages in St. Petersburg, Russia.     The study also assesses the effectiveness of having more consistent care from fewer     caregivers in a family-like environment.   "
169517|NCT00057304|"     The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to     placebo, are efficacious, safe and tolerable in improving glycemic control in patients with     type 2 diabetes. Doses of 2 to 5 mg/day will be studied.   "
169518|NCT00057317|"     The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to     placebo, are efficacious, safe and tolerable in improving glycemic control in patients with     type 2 diabetes. Doses of 5 to 20 mg/day will be studied.   "
169519|NCT00057330|"     The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes     disease in women who are not infected. The study will enroll approximately 7550 healthy     women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine     (experimental group) or hepatitis A vaccine (control group). Participants will receive their     assigned vaccine at 0, 1, and 6 months. Participants will have 9 scheduled study visits and     additional unscheduled visits for an evaluation of herpes if it is suspected. Participants     will be involved in study related procedures for up to 20 months.   "
169522|NCT00057369|"     This is a study to evaluate a new medication dosed once a week in the treatment of bacterial     infections in the blood from intravenous catheters (CR-BSI). The primary objective is to     evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI     relative to a standard of care treatment, vancomycin.   "
169523|NCT00057382|"     This is an international, multicenter, randomized study of intravenous T138067 versus     intravenous doxorubicin in hepatocellular carcinoma (liver cancer). Patients can not have     been treated before with chemotherapy and surgery is not recommended for their cancer. A     total of 750 subjects will be enrolled in this study.   "
169524|NCT00057395|"     To determine the rate of response and the duration of the response following therapy with     Aroplatinin patients with advanced solid malignancies.   "
169525|NCT00057408|"     This is a 12-week study which investigates the use of olanzapine to decrease disruptive     behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six     weeks of the study are double-blind and placebo controlled, meaning that patients receive     either placebo or olanzapine, and that neither the researchers nor the patients know whether     or not they are receiving placebo or olanzapine. In the second six weeks all of the patients     receive olanzapine. The purpose in using placebo is that it is otherwise impossible to know     how effective the drug is or whether or not the drug causes side effects. Patients treated     with placebo can have improvement and can have side effects. In the study patients receive a     psychiatric evaluation, physical examination, laboratory tests, and study medication     (olanzapine or placebo), free of charge.   "
169526|NCT00057421|"     This was a clinical trial in HIV infected patients with tuberculosis. The study assessed     whether the addition of prednisolone, a type of steroid medication, to the standard treatment     for tuberculosis improved immune and viral outcomes in the patients. The study demonstrated     that prednisolone increased the CD4 cell count as was hoped, but the beneficial effect was     short-lived and was gone within 4 months of stopping therapy. Therefore, the use of     prednisolone for tuberculosis in HIV infected patients is not recommended at this time.   "
169527|NCT00057434|"     The study will determine whether a daily vitamin and mineral supplement (a multivitamin     including Vitamin A) will improve health when added to standard chemotherapy for     tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected     and HIV uninfected patients.   "
169529|NCT00057460|"     This study will use transcranial magnetic stimulation (TMS) and electroencephalography (EEG)     to test the safety of an experimental anti-epileptic drug called Talampanel and learn how it     affects brain activity. Talampanel blocks a type of brain receptor called AMPA; inhibiting     this receptor may result in anti-seizure activity.      TMS stimulates the outer part of the brain, called the cortex. For this procedure, an     insulated wire coil is placed on the subject's scalp. A brief electrical current is passed     through the coil, creating a magnetic pulse that stimulates the brain. This may cause a     pulling sensation on the skin under the coil and muscle twitching in the face, arm, or leg.      EEG records the electrical activity of the brain, in the form of brain waves. For this     procedure, electrodes (metal discs with a conductive gel) attached to wires are affixed to     the scalp with a paste and the brain activity is recorded.      Healthy normal volunteers between 18 and 45 years of age may participate in this study.     Candidates will be screened with a physical and neurological examination, electrocardiogram     (EKG), blood tests, and blood pressure measurement. Women who are pregnant or nursing are     excluded from the study.      Participants will come to the NIH Clinical Center for three testing sessions, at least 1 week     apart, and a final follow-up visit. The procedure for each test session is as follows:      7 AM - Blood pressure is measured, EKG and EEC leads are placed, a heparin lock is inserted,     and a blood sample is drawn. The heparin lock is a thin needle enclosed in a thin plastic     tube. The needle guides the tube into a vein and is then removed, leaving the tube in place.     The indwelling tube allows multiple blood samples to be drawn without repeated needle sticks.      8 - 9 AM - TMS followed by EEG recording.      9 AM - Administration of Talampanel or placebo (pill with no active ingredient) by mouth.      10 AM - Blood sample #2.      10 AM -11 AM - TMS, followed by EEG recording every 5 minutes.      11 AM - Blood sample #3.      12 PM - Blood sample #4.      11 AM - 1 PM - EEG recording every 5 minutes/      4 PM - Blood sample #5.      5 PM - Discharge from Clinical Center.      At the final follow-up visit, the participant will talk with the doctor and have one final     blood draw.   "
169530|NCT00057473|"     This clinical research study is being conducted to investigate the effectiveness of combining     carboplatin and irinotecan, versus irinotecan alone, in treating children who have refractory     solid tumors.   "
169531|NCT00057486|"     There is no proven effective treatment for chronic diarrhea caused by the parasite     Cryptosporidium in advanced AIDS. This trial will test the safety of interleukin-12 (IL-12)     as part of a combination therapy for this parasite.   "
169532|NCT00057499|"     Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused     by the destruction of insulin-producing cells in the pancreas. People with T1DM do not     produce enough insulin, which is necessary for proper regulation of blood sugar levels.      T1DM is an autoimmune disease. An autoimmune disease is a disease in which the body's immune     system attacks the body itself. In addition to regulating blood sugar, insulin may have the     ability to protect cells in the pancreas from attack by the immune system. This study will     evaluate whether an insulin-based vaccine can protect cells from autoimmune destruction.      Study hypothesis: IFA-enhanced human insulin B-chain vaccination will lead to the arrest or     slowing of the ongoing autoimmunity, and this will result in an appreciable difference in     functioning B cell mass compared to the placebo treated group by the end of the study.   "
169533|NCT00057512|"     The purpose of this study will be to determine the safety and tolerability of intratumoral     M4N. Patients suffering from cancer of the head and neck that is recurrent after primary     treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. The design is     a Phase 1 dose escalation study of M4N administered intratumorally once weekly, initially for     three weeks. Dose will be escalated on the starting schedule to a target of 20 mg/cm3 tumor     volume and then, new patient cohorts will have their schedule extended to weekly M4N for 4     weeks. Dose escalation will continue, assuming tolerability, so that cohorts will be treated     for 6 weeks, and finally, 8 weeks.   "
169534|NCT00057525|"     This study will provide preliminary safety and comparative immunogenicity data for the E.coli     derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses     will range from 5 μg to 100 μg rPA, and at each dose-level, rPA will either be combined with     phosphate-buffered saline (PBS) or adsorbed to Alhydrogel.   "
169535|NCT00057538|"     The purpose of this study is to determine the effectiveness of a stress management group     intervention for people with HIV. The study will evaluate several outcomes, including     perceived stress, quality of life, psychosocial factors, and physiological measures of     stress.   "
169536|NCT00057551|"     This 24-week study, with a 12-month follow up period, will compare the effectiveness of     antidepressant medication alone to the combination of psychotherapy and antidepressant     medication in patients with chronic depression.   "
169537|NCT00057564|"     To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to     that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects     with active multiple myeloma   "
169538|NCT00057577|"     This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant     medication (ADM) enhances treatment for depression. This study will also test whether the     addition of CT to ADM will prevent recurrences of depression after therapy is over.   "
169539|NCT00057590|"     This study will assess the effects of depression treatment on employee productivity. This     study will also evaluate the impact of depression screening and outreach on employees'     receptivity to treatment.   "
169540|NCT00057603|"     This study will evaluate the use of Deep Brain Stimulation (DBS) to reduce symptom severity     and enhance the quality of life for patients with treatment-resistant obsessive compulsive     disorder (OCD).   "
169541|NCT00057616|"     Subjects are randomized to one of two treatment arms. All subjects are screened for     eligibility within 28 days prior to randomization. The study consists of a treatment phase     and a follow-up phase. Subjects are treated in repeating 4 week cycles.   "
169542|NCT00057629|"     This study will evaluate the effectiveness of a brief cognitive behavioral therapy,     administered by community agencies, for the treatment of patients with Post Traumatic Stress     Disorder (PTSD).   "
169543|NCT00057642|"     This study will develop an intervention that will increase the retention of Hispanics with     major depression in antidepressant therapy.   "
169544|NCT00057655|"     The purpose of this study is to determine whether access to behavioral health services has     been affected by welfare reform.   "
169545|NCT00057668|"     This study will determine the effectiveness of a combination of treatments in preventing     behaviors that are typically associated with Attention Deficit Hyperactivity Disorder (ADHD)     in young children.   "
169546|NCT00057681|"     This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate     (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar     disorder or symptoms of mania.   "
169841|NCT00061412|"     This project is evaluating programs to improve reading and writing skills in children who     have or are at risk for having reading disabilities. The project focuses on children who are     at-risk for low achievement in school and on children with dyslexia.   "
169547|NCT00057694|"     This study will explore adult adoptees' perceptions of the potential value of genetic and     family history information. Unlike most people, many adopted individuals do not have access     to personal or family medical information because of laws and practices that prevent     disclosure. Research suggests that adopted individuals are interested in obtaining this     information about their biological families. This study will examine adoptees':        -  Satisfaction with the amount of genetic information they have, their motivations for          wanting more information, and when it becomes important for them to have this          information.        -  Perceptions of the degree to which they believe genetics and family history influence          various traits and conditions.      The study will also explore adoptees' interactions with health care providers so that     recommendations can be developed for helping genetic counselors meet the needs of these     individuals.      English-speaking adoptees 18 years of age and older are eligible for this study. Those     enrolled will participate in a one-time telephone interview that will take about 45 to 60     minutes. The interview will obtain demographic information, such as the adoptee's age, sex,     racial and ethnic background, marital status, and education level, and will include questions     in the following areas:        -  Personal adoption story;        -  Perceptions of the role of the biological family history and medical information and its          importance and usefulness;        -  Perceptions of the influence of genetics and family history on health;        -  Reproductive history and pregnancy concerns related to being adopted;        -  Experiences and interactions with health care providers related to adoption;        -  Suggestions for improving interactions with health care providers.   "
169548|NCT00057707|"     This study will evaluate whether modafinil improves cognition in patients with schizophrenia     and healthy volunteers. Modafinil is a drug that has been FDA approved for day-time     sleepiness and allegedly increase the amount of the neurotransmitter dopamine in the frontal     cortex of the brain   "
169549|NCT00057720|"     The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as     compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT)     populations.   "
169550|NCT00057733|"     RATIONALE: Stress management techniques such as muscle relaxation, guided imagery, and     abdominal breathing may improve quality of life and decrease emotional distress in patients     who are undergoing radiation therapy for cancer.      PURPOSE: Randomized clinical trial to determine the effectiveness of stress management     training in helping cancer patients cope with the emotional distress of radiation therapy.   "
169551|NCT00057746|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known which radiation therapy regimen is more effective in preventing brain metastases in     patients with limited-stage small cell lung cancer while taking into account chronic     neurotoxicity from radiation therapy.      PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity     between three different brain irradiation regimens. The corresponding phase III component     addressing the prevention of brain metastases was run by EORTC and reported separately     (NCT00005062).   "
169552|NCT00057759|"     RATIONALE: Sildenafil may be effective in helping patients who have undergone treatment for     prostate cancer to have an erection for sexual activity and may improve sexual satisfaction     and quality of life.      PURPOSE: Randomized clinical trial to study the effectiveness of sildenafil in treating     erectile dysfunction in patients who have undergone radiation therapy and hormone therapy for     prostate cancer in clinical trial RTOG-9910.   "
169553|NCT00057785|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation     therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth     dryness, and may help patients live more comfortably. Drugs used in chemotherapy use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy     techniques with or without chemotherapy in reducing mouth dryness in patients who have     nasopharyngeal cancer.   "
169554|NCT00057798|"     RATIONALE: Determination of genetic changes in patients with non-small cell lung cancer may     help predict the outcome of treatment. Drugs used in chemotherapy use different ways to stop     tumor cells from dividing so they stop growing or die. Combining more than one drug, and     giving them before surgery, may shrink the tumor so that it can be removed during surgery.      PURPOSE: Phase II trial to study genetic changes and the effectiveness of combining     vinorelbine with gemcitabine before surgery in treating patients who have stage IB, stage II,     or stage III non-small cell lung cancer.   "
169555|NCT00057811|"     Phase II trial to study the effectiveness of combining rituximab and rasburicase with     combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell     leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.     Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they     stop growing or die. Combining more than one drug with rituximab may kill more cancer cells.     Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of     chemotherapy.   "
169556|NCT00057837|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is more effective in treating     extensive-stage small cell lung cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of two combination     chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.   "
169557|NCT00057850|"     Phase I/II trial to study the effectiveness of combining BMS-247550 with cisplatin in     treating patients who have metastatic or recurrent head and neck cancer. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than one drug may kill more tumor cells.   "
169558|NCT00057863|"     Phase II trial to study the effectiveness of combining oxaliplatin with paclitaxel in     treating patients who have locally recurrent or metastatic cervical cancer. Drugs used in     chemotherapy use different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than one drug may kill more tumor cells.   "
170706|NCT00072631|"     The purpose of this study is to determine if erlotinib will improve disease at doses that     produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.   "
169559|NCT00057876|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     tumor cells. It is not yet known whether gemcitabine is more effective with or without     radiation therapy in treating pancreatic cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without     radiation therapy in treating patients who have locally advanced, unresectable pancreatic     cancer.   "
169560|NCT00057889|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have metastatic renal cell cancer (kidney cancer) that is refractory to     treatment with interleukin-2 or unable to be treated with interleukin-2.   "
169561|NCT00057915|"     RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may make the     body build an immune response to kill cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with refractory stage IV cancer.   "
169562|NCT00057928|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known whether cisplatin is more effective when combined with paclitaxel or gemcitabine in     treating cervical cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with     paclitaxel to that of cisplatin combined with gemcitabine in treating women who have     recurrent, persistent, or metastatic cervical cancer.   "
169563|NCT00057941|"     This randomized phase II trial is studying how well giving gefitinib together with     anastrozole works compared to giving gefitinib together with fulvestrant in treating     postmenopausal women with recurrent or metastatic breast cancer. Estrogen can stimulate the     growth of breast cancer cells. Hormone therapy using anastrozole and fulvestrant may fight     breast cancer by blocking the use of estrogen. Gefitinib (ZD1839) may stop the growth of     cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether     gefitinib is more effective when combined with anastrozole or fulvestrant in treating breast     cancer.   "
169564|NCT00057954|"     RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet (UV)     light and drugs outside the body to inactivate T cells. Pentostatin may suppress the immune     system and reduce the chance of developing graft-versus-host disease (GVHD) following bone     marrow transplantation. Combining photopheresis with pentostatin and total-body irradiation     may be effective in killing cancer cells before bone marrow transplantation.      PURPOSE: This phase II trial is studying how well giving photophoresis together with     pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone     marrow transplantation works in treating patients with relapsed non-Hodgkin's or Hodgkin's     lymphoma.   "
169565|NCT00057967|"     RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with     relapsed or refractory advanced mycosis fungoides or Sézary syndrome.   "
169566|NCT00057980|"     RATIONALE: Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor.     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining celecoxib with epirubicin may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of epirubicin when     given together with celecoxib and to see how well it works in treating patients with     hepatocellular carcinoma (liver cancer).   "
169595|NCT00058448|"     RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have     locally advanced or metastatic penile cancer.   "
173631|NCT00116558|"     The purposes of the study are to determine the energy balance and evaluate the nutritional     status of patients with ALS, and to investigate the use of NIPPV as respiratory support to     treat patients with ALS.   "
169567|NCT00057993|"     RATIONALE: The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2     on their surface and either kill them or deliver tumor-killing substances to them without     harming normal cells. Estrogen can stimulate the growth of breast cancer cells. Hormone     therapy using exemestane may fight breast cancer by reducing the production of estrogen.     Combining trastuzumab with exemestane may be an effective treatment for breast cancer with     high amounts of HER2.      PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with exemestane     in treating postmenopausal women who have metastatic or locally advanced HER2-positive breast     cancer.   "
169568|NCT00058006|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of celecoxib may be an effective way to prevent     the recurrence of stage I or stage II head and neck cancer or stage I non-small cell lung     cancer.      PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works     compared to that of a placebo in preventing disease recurrence in patients with stage I or     stage II head and neck cancer or stage I non-small cell lung cancer.   "
169569|NCT00058019|"     This phase II trial is studying how well ixabepilone works in treating patients with relapsed     or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as     ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing     or die.   "
169570|NCT00058032|"     RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective     treatment for cancer. It is not yet known if ultrasound is more effective with or without     measuring CA 125 levels in detecting ovarian cancer in postmenopausal women.      PURPOSE: Randomized clinical trial to study the effectiveness of ultrasound with or without     measuring CA 125 levels in detecting ovarian cancer in postmenopausal women.   "
169571|NCT00058045|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.     Stem cell factor may increase the number of immune cells found in bone marrow or peripheral     blood and may help a person's immune system recover from the side effects of cancer therapy.      PURPOSE: Phase I trial to study the effectiveness of combining interleukin-2 with stem cell     factor in treating patients who have AIDS or AIDS-related cancer.   "
169572|NCT00058058|"     RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the     ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral     breast cancer.      PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected     breast of women recently diagnosed with unilateral breast cancer.   "
169573|NCT00058071|"     RATIONALE: Amifostine may be effective in relieving numbness, tingling, and other symptoms of     peripheral neuropathy. It is not yet known whether amifostine is effective in treating     peripheral neuropathy in patients who have received chemotherapy for cancer.      PURPOSE: This randomized phase III trial is studying amifostine to see how well it works     compared to observation in relieving numbness, tingling, and other symptoms of peripheral     neuropathy in patients who have received platinum-based chemotherapy (such as cisplatin or     carboplatin) for cancer.   "
169574|NCT00058084|"     This randomized phase II trial is studying ixabepilone to see how well it works compared to     mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not     responded to paclitaxel, docetaxel, or hormone therapy. Drugs used in chemotherapy work in     different ways to stop tumor cells from dividing so they stop growing or die. Some tumors     become resistant to chemotherapy drugs. Ixabepilone may reduce resistance to the drugs and     allow the tumor cells to be killed. It is not yet known which chemotherapy regimen is more     effective in treating metastatic prostate cancer   "
169575|NCT00058097|"     Phase II trial to study the effectiveness of combining tipifarnib with radiation therapy in     treating patients who have newly diagnosed glioblastoma multiforme. Tipifarnib may stop the     growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation     therapy uses high-energy x-rays to damage tumor cells. Combining tipifarnib with radiation     therapy may make the tumor cells more sensitive to radiation therapy and may kill more tumor     cells.   "
169576|NCT00058123|"     RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune     system and stop tumor cells from growing.      PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with     recurrent, progressive, or relapsed anaplastic glioma.   "
169577|NCT00058149|"     RATIONALE: Drugs used in chemotherapy such as gemcitabine and oxaliplatin use different ways     to stop tumor cells from dividing so they stop growing or die. Combining more than one drug     and giving them in different ways may kill more tumor cells. It is not yet known whether     gemcitabine is more effective with or without oxaliplatin in treating pancreatic cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or     without oxaliplatin in treating patients who have locally advanced or metastatic pancreatic     cancer.   "
169578|NCT00058188|"     RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation     therapy. It is not yet known whether zoledronate combined with calcium is more effective than     calcium alone in preventing bone loss.      PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with     calcium with that of calcium alone in preventing bone loss in patients with stage III or     stage IV prostate cancer who have received long-term androgen deprivation therapy.   "
169579|NCT00058201|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known which chemotherapy regimen is more effective,     or whether chemotherapy is more effective than observation, in treating pancreatic cancer     after surgery.      PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no     further therapy in treating patients who have completely resected pancreatic cancer.   "
169580|NCT00058214|"     Phase II trial to study the effectiveness of perifosine in treating patients who have     recurrent prostate cancer. Drugs used in chemotherapy such as perifosine use different ways     to stop tumor cells from dividing so they stop growing or die   "
169618|NCT00049465|"     RATIONALE: Telephone counseling by trained counselors may enhance the well-being and quality     of life of patients who have undergone stem cell transplantation for cancer.      PURPOSE: Randomized clinical trial to compare the effectiveness of standard follow-up care     with extended follow-up care in treating patients who have undergone stem cell     transplantation for cancer.   "
169581|NCT00058227|"     This phase I trial studies the side effects, best way to give, and the best dose of alvocidib     when given together with fludarabine phosphate and rituximab in treating patients with     previously untreated or relapsed lymphoproliferative disorders or mantle cell lymphoma.     Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or     deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy such as alvocidib and fludarabine use different ways to stop cancer cells from     dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy     may kill more cancer cells.   "
169582|NCT00058240|"     This phase I/II trial studies the side effects and best dose of flavopiridol in treating     patients with previously treated chronic lymphocytic leukemia or lymphocytic lymphoma. Drugs     used in chemotherapy such as flavopiridol work in different ways to stop cancer cells from     dividing so they stop growing or die.   "
169583|NCT00058253|"     This phase I trial is studying the side effects and best dose of combination chemotherapy in     treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy,     such as docetaxel and 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may     kill more tumor cells.   "
169584|NCT00058266|"     RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary     for cancer cell growth.      PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with     localized prostate cancer who are planning to undergo radical prostatectomy.   "
169585|NCT00058279|"     RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the     immune system and stop tumor cells from growing. Interleukin-2 may stimulate a person's white     blood cells to kill tumor cells. Combining monoclonal antibody therapy with interleukin-2 may     kill more tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of combining monoclonal antibody therapy     with interleukin-2 in treating patients who have metastatic melanoma.   "
169842|NCT00061425|"     The purpose of this trial is to determine the safety of a 90Y-radiolabeled, humanized     (CDR-grafted) form of the LL2 monoclonal antibody in patients with Non-Hodgkin's lymphoma     (NHL) at different dose levels.   "
169586|NCT00058292|"     RATIONALE: Radiolabeled monoclonal antibodies such as yttrium Y90 ibritumomab tiuxetan can     locate cancer cells and deliver radioactive cancer-killing substances to them without harming     normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from     dividing so they stop growing or die. Combining yttrium Y90 ibritumomab tiuxetan and     chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses     of chemotherapy drugs and kill more cancer cells.      PURPOSE: This phase I trial is studying how well giving yttrium Y90 ibritumomab tiuxetan with     high-dose chemotherapy followed by autologous stem cell transplant work in treating patients     with relapsed or refractory non-Hodgkin's lymphoma.   "
169587|NCT00058305|"     Phase II trial to study the effectiveness of combining bryostatin 1 with vincristine in     treating patients who have progressive or relapsed non-Hodgkin's lymphoma after autologous     bone marrow transplantation or autologous stem cell transplantation. Drugs used in     chemotherapy such as vincristine use different ways to stop cancer cells from dividing so     they stop growing or die. Bryostatin 1 may help vincristine kill more cancer cells by making     the cells more sensitive to the drug   "
169588|NCT00058318|"     RATIONALE: Drugs used in chemotherapy such as gemcitabine and capecitabine use different ways     to stop tumor cells from dividing so they stop growing or die. Combining more than one     chemotherapy drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine     in treating patients who have advanced renal cell cancer (kidney cancer).   "
169589|NCT00058331|"     RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients     with solid tumors. It is not yet known whether epoetin alfa given once a week is more     effective than epoetin alfa given once every 3 weeks in treating anemia.      PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating     anemia in patients who have solid tumors.   "
169590|NCT00058357|"     RATIONALE: A lidocaine patch may be effective in relieving numbness, tingling, and other     symptoms of neuropathy. It is not yet known whether a lidocaine patch is effective in     treating neuropathy in patients who have undergone surgery for cancer.      PURPOSE: This randomized phase III trial is studying lidocaine patch to see how well it works     compared to a placebo patch in relieving numbness, tingling, and other symptoms of neuropathy     in patients who have undergone surgery for cancer.   "
169591|NCT00058370|"     RATIONALE: Radioimmunotherapy uses radiolabeled monoclonal antibodies to locate tumor cells     and deliver radioactive tumor-killing substances to them without harming normal cells.     Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy     use different ways to stop tumor cells from dividing so they stop growing or die. Combining     intrathecal radioimmunotherapy and radiation therapy with combination chemotherapy may kill     any tumor cells remaining after surgery.      PURPOSE: Phase II trial to study the effectiveness of combining intrathecal     radioimmunotherapy and radiation therapy with combination chemotherapy in treating patients     who have undergone surgery for medulloblastoma.   "
169592|NCT00058396|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic     lymphoma.   "
169593|NCT00058422|"     RATIONALE: Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can     locate cancer cells and either kill them or deliver radioactive cancer-killing substances to     them without harming normal cells. Drugs used in chemotherapy use different ways to stop     cancer cells from dividing so they stop growing or die. Combining rituximab and combination     chemotherapy with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining rituximab and combination     chemotherapy with yttrium Y 90 ibritumomab tiuxetan in treating older patients who have     B-cell lymphoma that has not been previously treated.   "
169594|NCT00058435|"     RATIONALE: Vaccines made from monoclonal antibodies combined with tumor cells may make the     body build an immune response to kill tumor cells.      PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating     patients who have ovarian epithelial, fallopian tube, or peritoneal cancer.   "
169596|NCT00058461|"     This phase II trial is studying how well rituximab together with ifosfamide, carboplatin, and     etoposide works in treating young patients with recurrent or refractory non-Hodgkin's     lymphoma or acute lymphoblastic leukemia. Chemotherapy drugs, such as ifosfamide,     carboplatin, and etoposide, work in different ways to stop cancer cells from dividing so they     stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.     Combining ifosfamide, carboplatin, and etoposide with rituximab may kill more cancer cells.   "
169597|NCT00058474|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, fluorouracil, and oxaliplatin     work in different ways to stop tumor cells from dividing so they stop growing or die.     Radiation therapy uses high-energy x-rays to damage tumor cells.      PURPOSE: This randomized phase III trial is studying radiation therapy and either     capecitabine or fluorouracil with or without oxaliplatin and comparing them to see how well     they work when given before surgery in treating patients with resectable rectal cancer. It is     not yet known whether radiation therapy and either capecitabine or fluorouracil is more     effective with or without oxaliplatin in treating rectal cancer.   "
169598|NCT00058487|"     RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop tumor     cells from dividing so they stop growing or die. Thalidomide may stop the growth of     hepatocellular (liver) cancer by stopping blood flow to the tumor. Combining epirubicin with     thalidomide may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with thalidomide     in treating patients who have unresectable or metastatic liver cancer.   "
169607|NCT00049309|"     RATIONALE: A diet that is low in fat and/or high in flaxseed may slow or prevent disease     progression of prostate cancer.      PURPOSE: Randomized phase II trial to study the effectiveness of a diet that is low in fat     and/or high in flaxseed in slowing or preventing disease progression in patients who have     newly diagnosed prostate cancer.   "
170757|NCT00073320|"     The purpose of the study is to compare the pharmacokinetic parameters (blood concentrations)     of i.m. paliperidone palmitate after administration in 2 different injection sites (deltoid     or gluteal).   "
169599|NCT00058526|"     Treatment phase:      The purpose of this study is to evaluate the safety and the immune response elicited by a new     anti-cancer therapy in patients with breast cancer in remission but who are at high risk of     relapse. The study product is an immunotherapeutic consisting of the recombinant dHER2     protein combined with an immunostimulant called AS15. The study aims to determine the optimal     of three different dose levels of dHER2 combined with the same fixed dose of AS15 by     assessing the safety and the immune response elicited after a series of injections of the     study product.      Five-year follow-up phase:      This part of the study aims to assess any late onset toxicity of the study treatment through     yearly follow-up visits and to monitor the patients' survival and disease status up to five     years after the last administration of the study treatment. The patients' immune response is     also measured to assess the robustness of the immune response elicited by the study     treatment.   "
169600|NCT00058539|"     The purpose of this study is to evaluate safety and efficacy of Omnitarg (Pertuzumab) on     cancerous lesions in men with castration-resistant (hormone-refractory) prostate cancer.   "
169601|NCT00058552|"     The purpose of this study is to determine if the study drug pertuzumab is effective in     treating patients with advanced ovarian cancer that is refractory to, or has recurred     following, prior chemotherapy.   "
169602|NCT00058578|"     Systemic Sclerosis is a disease that may be caused by the immune system reacting against skin     and certain organs. It is possible, that by changing the immune system we can modify the     progression of this disease.      Stem cells are created in the bone marrow. They mature into different types of blood cells     that are needed including red blood cells, white blood cells, and platelets. In this study,     we will stimulate the bone marrow to make extra stem cells. Next we will collect the stem     cells, select specific cells, and store them. We will then give high dose chemotherapy that     will destroy the patients immune system. We will then give back the selected stem cells we     collected. We believe that these selected stem cells may be able to re-create the immune     system without the portion that causes Systemic Sclerosis.      The purpose of this study is to try to discover if stem cell transplantation can help     patients with Systemic Sclerosis. We will also try to learn what the side effects are of this     treatment in patients with Systemic Sclerosis. We hope that this treatment will help to     relieve the symptoms patients are experiencing, although we do not know if it will.   "
169603|NCT00058591|"     Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or     commonly known as mono or the kissing disease) associated disorder. This disorder may cause     chronic tiredness and fevers and sometimes be complicated by life threatening problems such     as multi-organ failure, chronic (ongoing) pneumonia, and lymphoproliferative diseases     (diseases involving the lymph nodes which could eventually show up as leukemia or a tumor).     The reasons for the body's inability to control the EBV infection are still unknown and no     effective treatment is currently available.      This research study uses Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). We     want to see if we can grow special white blood cells, called T cells, that have been trained     to kill EBV infected cells in the laboratory and see if these cells may help control the EBV     infection when given back to the patient.      The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn     what the side effects are, and to see whether this therapy might help the body fight off the     SCAEBV infection.   "
169604|NCT00058604|"     Patients who may have been infected with EBV (Epstein-Barr Virus) before or after the time of     their transplant have a higher risk of developing Lymphoproliferative Disease (LPD) or may     already have a form of this disease.      This research study uses Epstein Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs).     These cells have been trained to attack and kill (cytotoxic) EB virus infected cells.      We make these cells from the patients blood by first growing an EBV infected B cell line by     infecting the blood with an EBV virus called B-95. We then treat these EBV infected B cells     with radiation so they cannot grow and use them to stimulate T cells. This stimulation will     train the T cells to kill EBV infected cells. We will then test the T cells to make sure they     kill the EBV infected cells.      The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn     what the side effects are, and to see whether this therapy might help prevent or cure EBV     related cancers in solid organ transplant patients   "
169632|NCT00049699|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have     advanced or metastatic cancer.   "
169633|NCT00049712|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have refractory advanced solid tumors or lymphoma.   "
169605|NCT00058617|"     Patients have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma which has     come back or not gone away after treatment, including the best treatment known for relapsed     Lymphoma.      Patients are being asked to volunteer to be in a research study using Epstein Barr virus     specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has never been     used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been     used successfully in children with other types of blood cancer caused by EBV after bone     marrow transplantation. Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of     infection with the virus that causes infectious mononucleosis Epstein Barr virus before or at     the time of their diagnosis of the Lymphoma. EBV is often found in the cancer cells     suggesting that it may play a role in causing Lymphoma. The cancer cells infected by EBV are     very clever because they are able to hide from the body's immune system and escape     destruction. Investigators want to see if it's possible to grow special white blood cells,     called T cells, that have been trained to kill EBV infected cells.      Purpose The purpose of this study is to find the largest safe dose of EBV specific cytotoxic     T cells, to learn what the side effects are and to see whether this therapy might help     patients with Hodgkin disease and non-Hodgkin Lymphoma.   "
169606|NCT00058656|"     Patients will have immune cells collected and then expanded outside of the body. Patients     will receive an infusion of a large number of expanded immune cells. There will be three dose     levels studied. The goal of the study will be to determine the safety as well as potential     efficacy of this treatment.   "
169608|NCT00049322|"     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, cisplatin, and     mitomycin, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking     the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Monoclonal     antibodies, such as bevacizumab, can kill any tumor cells that are left after     chemoembolization by blocking their ability to grow and spread.      PURPOSE: This randomized phase II trial is studying to see if chemoembolization followed by     bevacizumab works better than chemoembolization alone in treating patients who have liver     cancer that cannot be removed with surgery.   "
169609|NCT00049335|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating older patients     who have metastatic or recurrent colorectal cancer that cannot be surgically removed.   "
169610|NCT00049348|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it     can be removed during surgery.      PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens     combining chemotherapy with radiation therapy in treating patients who are undergoing surgery     for locally advanced pancreatic cancer.   "
169611|NCT00049361|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining     whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy     with thalidomide and temozolomide in treating patients who have newly diagnosed brain     metastases.   "
169612|NCT00049374|"     RATIONALE: Thalidomide may slow the growth of cancer cells. Oblimersen may increase the     effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the     drugs.      PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and dexamethasone     with oblimersen in treating patients who have relapsed or refractory multiple myeloma.   "
169613|NCT00049387|"     This phase I trial is studying the side effects and best dose of tipifarnib when given     together with temozolomide and radiation therapy in treating patients with newly diagnosed     glioblastoma multiforme or gliosarcoma. Tipifarnib may stop the growth of tumor cells by     blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy, such as     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage     tumor cells. Combining tipifarnib, temozolomide, and radiation therapy may kill more tumor     cells.   "
169614|NCT00049400|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in     treating patients with advanced solid tumors or lymphomas and liver dysfunction.   "
169615|NCT00049413|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Combining     chemotherapy with monoclonal antibody therapy may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and     cyclophosphamide with rituximab in treating patients who have chronic lymphocytic leukemia or     lymphocytic lymphoma.   "
169616|NCT00049439|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining lomustine, etoposide,     cyclophosphamide, and procarbazine in treating patients who have AIDS-related non-Hodgkin's     lymphoma.   "
169617|NCT00049452|"     RATIONALE: It is not yet known whether zoledronate is effective in preventing bone loss in     premenopausal women who are receiving adjuvant chemotherapy after undergoing surgery for     early stage breast cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in     preventing bone loss in premenopausal women who are receiving chemotherapy after surgery for     early stage breast cancer.   "
169619|NCT00049504|"     This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide,     tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone     marrow transplant works in treating patients with high-risk hematologic cancer. Giving low     doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body     irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by     stopping them from dividing or killing them. Giving cyclophosphamide after transplant may     also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The     donated stem cells may replace the patient's immune system cells and help destroy any     remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a     donor can also make an immune response against the body's normal cells. Giving tacrolimus and     mycophenolate mofetil after the transplant may stop this from happening   "
169620|NCT00049517|"     RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the     growth of cancer cells. It also helps stop the patient's immune system from rejecting the     transplanted stem cells. When the healthy stem cells are infused into the patient they may     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and     platelets. If the patient's stem cells are to be transplanted, the patient is also treated     with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells     or deliver cancer-killing substances to them without harming normal cells. It is not yet     known whether combination chemotherapy is more effective with or without gemtuzumab     ozogamicin followed by stem cell transplant in treating acute myeloid leukemia.      PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab     ozogamicin, and stem cell transplant to see how well they work compared to combination     chemotherapy and peripheral stem cell transplant alone in treating patients with acute     myeloid leukemia.   "
170758|NCT00073333|"     This study will determine whether people with social phobia are deficient in certain social     skills.   "
169622|NCT00049543|"     This randomized phase III trial studies how well gefitinib works in treating patients with     stage IB, II, or IIIA non-small cell lung cancer that was completely removed by surgery.     Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. It is not yet known if gefitinib may be an effective treatment in preventing tumors     from returning after they have been removed by surgery.   "
169623|NCT00049556|"     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor     cells and slow the growth of cervical cancer. Comparing results of diagnostic procedures     performed before, during, and after treatment with gefitinib may help doctors predict a     patient's response to treatment and help plan the most effective treatment.      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with     cervical cancer.   "
169624|NCT00049569|"     Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop     growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes     necessary for cancer cell growth. Combining more than one chemotherapy drug with imatinib     mesylate may kill more cancer cells. Randomized phase II trial to study the effectiveness of     combination chemotherapy and imatinib mesylate in treating children who have relapsed acute     lymphoblastic leukemia.   "
169625|NCT00049582|"     This phase I trial is studying the side effects and best dose of decitabine in treating     patients with myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy     use different ways to stop cancer cells from dividing so they stop growing or die.   "
169626|NCT00049595|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known which combination chemotherapy regimen is more effective in treating stage III     or stage IV Hodgkin's lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination     chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.   "
169627|NCT00049608|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor     cells from dividing so they stop growing or die. Mistletoe may slow the growth of tumor cells     and may be an effective treatment for solid tumors.      PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine with mistletoe in     treating patients who have advanced solid tumors.   "
169628|NCT00049634|"     RATIONALE: Giving chemotherapy drugs before a donor peripheral blood stem cell transplant     helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system     from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused     into the patient they may help the patient's bone marrow make stem cells, red blood cells,     white blood cells, and platelets. Giving colony-stimulating factors, such as G-CSF, to the     donor helps the stem cells move from the bone marrow to the blood so they can be collected     and stored.      PURPOSE: This phase I/II trial is studying how well donor peripheral stem cell transplant     works in treating patients with myelodysplastic syndrome, acute myeloid leukemia, or     myeloproliferative disorder.   "
169629|NCT00049660|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known if capecitabine is more effective than     vinorelbine in treating metastatic breast cancer.      PURPOSE: Randomized phase II/III trial to compare the effectiveness of capecitabine with that     of vinorelbine in treating women who have metastatic breast cancer that has been previously     treated with chemotherapy.   "
169630|NCT00049673|"     RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the     tumor. It is not yet known whether combining thalidomide with prednisone and giving them     after autologous stem cell transplantation may be effective in treating multiple myeloma.      PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how     well they work compared to observation in treating patients who have undergone stem cell     transplantation for multiple myeloma.   "
169631|NCT00049686|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have     relapsed or refractory leukemia or myelodysplastic syndrome.   "
169634|NCT00049725|"     This study will evaluate the effectiveness of the drug daclizumab for treating patients with     chronic immune thrombocytopenia (ITP), a disease in which the immune system destroys     platelets (blood cells involved in the clotting process). Patients with ITP have abnormal     bruising and bleeding; severe disease can be life-threatening. For many patients, standard     drug treatments are not effective, and many of the drugs used may have significant side     effects with long-term use. Daclizumab is a genetically engineered antibody that suppresses     the immune system and has been used primarily to prevent rejection in patients who have had     organ transplants. Daclizumab has fewer side effects than other immune suppressant drugs.      Patients with ITP 18 years of age or older who have platelet counts less than     30,000/microliter and have not responded to prednisone treatment may be eligible for this     study. Candidates will be screened with a medical history, physical examination, and blood     tests.      Participants will have a 15-minute infusion of daclizumab every 2 weeks for five doses. They     will be seen by a physician at least once every 2 weeks while receiving the drug and then at     weeks 12, 20, and 32 of the study. Blood will be drawn at the 4- and 8-week visits during     treatment for diagnostic tests, and at each follow-up visit after treatment to assess the     response to therapy.      Patients who respond well to treatment will have their pre-study immunosuppressive medicines     tapered gradually one at a time starting with the 1-month follow-up visit. If their platelet     count falls to pre-treatment levels at any time during the tapering, the dose reduction will     stop and pre-study medications will be re-started, if necessary.   "
169666|NCT00050141|"     The purpose of this study is to determine if the addition of tipifarnib to standard letrozole     therapy leads to a better response to treatment for your cancer in comparison to letrozole     plus a placebo. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors     (FTI). It blocks proteins that make cancer cells grow.   "
169667|NCT00050154|"     The purpose of this study is to characterize the hematological response rate, as well as     other parameters of efficacy and safety induced by tipifarnib in patients with high-risk     myelodysplastic syndrome (MDS). Tipifarnib belongs to a class of drugs called Farnesyl     Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.   "
169635|NCT00049738|"     The purpose of this study is to screen and evaluate children with psychotic disorders to     establish or confirm their diagnosis and to collect data about their condition. This study     will also recruit individuals for various treatment studies.      Childhood psychotic disorders are debilitating conditions in which children have auditory or     visual hallucinations and disorganized thoughts. This study will examine psychotic disorders     in children in an inpatient setting.      Participants in this study will be admitted to the NIH Clinical Center for up to 9 weeks     under one or more of the following conditions: current medication, no medication, or tapered     medication. Participants will undergo blood, urine, metabolic, and intellectual functioning     tests. An electrocardiogram (EKG) and electroencephalogram (EEG) will be performed. A     magnetic resonance imaging (MRI) scan of the brain will be taken and infrared oculography     will be used to measure eye movements. Participants and their family members may also be     asked to participate in a study of genetics in children with psychotic illnesses. Children     meeting criteria for childhood onset schizophrenia may be offered participation in a     medication comparison protocol.   "
169636|NCT00049751|"     The purpose of the study is to evaluate safety by collecting serious adverse events in     subjects with moderately to severely active rheumatoid arthritis who are unable to obtain     etanercept and who have failed one or more prior disease-modifying antirheumatic drugs     (DMARDs).   "
169637|NCT00049764|"     The purposes of this study are to determine:        1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their          condition more often or recover faster than children who do not receive drotrecogin alfa          (activated).        2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with          severe sepsis.        3. The side effects that might be associated with drotrecogin alfa (activated)          administration to children with severe sepsis.   "
169638|NCT00049777|"     The purpose of this study is to evaluate the relative efficacy and safety of prophylactic     heparin co-administration during drotrecogin alfa (activated) infusion in the treatment of     severe sepsis in the adult.   "
169639|NCT00049790|"     The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein     administered in combination with paclitaxel and carboplatin to patients with non-small-cell     lung cancer.   "
169640|NCT00049803|"     The initial portion of the protocol involves discontinuing any medications for cataplexy that     the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of     study drug or placebo over a 10-11 week period. During the trial, narcolepsy symptoms will be     evaluated. Participants are allowed to continue using stimulant medications at constant doses     during the study. A total of 1 to 3 daytime visits in addition to 4 overnight visits to the     sleep center will be required to complete the study.   "
169641|NCT00049816|"     This trial will test if walking or bicycling exercise is effective as a non-surgical     treatment option for patients with knee osteoarthritis.   "
169642|NCT00049829|"     HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per     year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures     are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine     the benefits of zoledronic acid in fracture reduction at both the hip and spine.   "
169643|NCT00049842|"     The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no     treatment for the prevention of fibrosis progression in adult participants with moderate to     severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol     treatment in protocol P02370 (NCT00039871).   "
169644|NCT00049855|"     To develop new statistical methods to explore genetic mechanisms that contribute to the     development of hypertension.   "
169645|NCT00049868|"     To develop genetic maps for the genome-wide screening markers used by multiple investigators     and to investigate map differences between sexes and different ethnic groups.   "
169646|NCT00049881|"     To conduct genetic studies of the metabolic syndrome characterized by very low levels of high     density lipoprotein cholesterol (HDL-C), hypertriglyceridemia, and obesity.   "
169647|NCT00049894|"     To investigate mechanisms of recurrent stroke.   "
169648|NCT00049907|"     To examine the epidemiology of renal disease and its relationship to cardiovascular disease.   "
169649|NCT00049920|"     To perform a follow-up study of cerebrovascular disease in the Atherosclerosis Risk in     Communities (ARIC) magnetic resonance imaging subcohort.   "
169650|NCT00049933|"     To examine in postmenopausal women the potential interactions of hormone replacement therapy     with other blood clotting factors on the risk of cardiovascular diseases such as heart attack     or stroke.   "
169651|NCT00049946|"     A Placebo Controlled Study For Patients With Schizophrenia   "
169652|NCT00049959|"     The purpose of the two studies is to determine whether an experimental therapy using a     photoactive drug, verteporfin, in combination with direct light exposure of basal cell     carcinoma of the skin can safely eliminate these skin tumors.   "
169653|NCT00049972|"     A study to obtain safety and tolerability data   "
169654|NCT00049985|"     The purpose of this study is to determine whether increasing hemoglobin concentration in     patients with heart failure and anemia will improve the patients' functional status,     including exercise tolerance and New York Heart Association (NYHA) classification.   "
169655|NCT00049998|"     The purpose of this study is to collect information on how effective and how well tolerated     an oral investigational drug is compared to a standard intravenous drug in patients with     pretreated, advanced non-small lung cancer (NSCLC).   "
169656|NCT00050011|"     This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6     months when given upfront versus delayed start (based on a post-baseline BMD T- Score below     -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to     trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage     I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive     Letrozole 2.5 mg daily as an adjuvant therapy.   "
169676|NCT00050284|"     The purpose of this study is to determine whether patients who have asymptomatic HIV     infection can discontinue antiretroviral therapy (ART) without adverse clinical, virologic,     or immunologic consequences. This study will also assess the virologic, immunologic, and     clinical outcomes in any patients who restart ART.   "
169657|NCT00050024|"     This study will use transcranial magnetic stimulation (TMS) and electrical stimulation of     nerves to examine how the brain controls muscle movement in focal hand dystonia (writer's     cramp). Normally, when a person moves a finger, the brain's motor cortex prevents the other     fingers from moving involuntarily. Patients with focal hand dystonia have difficulty with     individualized finger movements, possibly due to increased excitability of the motor cortex.     Musicians, writers, typists, athletes and others whose work involves frequent repetitive     movements may develop focal dystonia of the hand.      Healthy normal volunteers and patients with focal dystonia 18 years of age and older may be     eligible for this study.      For the TMS procedure, subjects are seated in a comfortable chair with their hands placed on     a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical     current is passed through the coil, creating a magnetic pulse that stimulates the brain. This     may cause muscle, hand or arm twitching if the coil is near the part of the brain that     controls movement, or it may induce twitches or transient tingling in the forearm, head or     face muscles. Subjects will be asked to move a finger. Just before this movement, a brief     electrical stimulation will be applied to the end of either the second or fifth finger. Metal     electrodes will be taped to the skin over the muscle for computer recording of the electrical     activity of the hand and arm muscles activated by the stimulation. The testing will last 2-3     hours.   "
169658|NCT00050037|"     The purpose of this study is to compare the efficacy of a CD-ROM-based cognitive-behavioral     therapy (CBT) to traditional manual-based group therapy for obese individuals with     binge-eating disorder (BED) and other unhealthy eating behaviors. A second goal is to     encourage a healthy lifestyle in patients with BED.   "
169659|NCT00050050|"     This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating     the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not     responded to drug treatment.      Study hypothesis: CBT is an effective treatment for adult ADHD.   "
169660|NCT00050063|"     The purpose of this study is to determine whether therapeutic HIV vaccines can help the     immune system control HIV viral load after anti-HIV drugs are discontinued.   "
169661|NCT00050076|"     The purpose of this study is to determine the effect of two different doses of MCC-135, once     daily (QD) or twice daily (BID), on the disease state and the quality of life in subjects     with congestive heart failure.   "
169662|NCT00050089|"     This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who     have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including     all three classes of anti-HIV drugs. The first randomization will allocate patients to an     intended 3-month antiretroviral drug-free period (ARDFP) or No ARDFP. The second     randomization will allocate patients to Mega-ART (5+ drugs) or to Standard-ART (up to 4     drugs). The total study duration is 6.5 years with 5 years of intake and 1.5 year (minimum)     of follow-up; median duration of patient follow-up is about 4 years. The target sample size     is 390 patients and will provide 75% power to detect a 30% reduction in the hazard rate for     the primary endpoint with mega-ART. Sixty-four sites will be participating in the trial--24     VA, 19 UK and 21 Canada.   "
169663|NCT00050102|"     The objectives of this study are to determine the safety and activity profile of multiple     doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy     (decarbazine [DTIC]) can augment the effects of MDX-010 in patients with chemotherapy naïve     metastatic melanoma with a tolerable toxicity profile.   "
169664|NCT00050115|"     This study will collect samples of blood, stool, bone marrow, or other tissues from patients     with hepatitis-associated aplastic anemia to investigate a possible association between     exposure to viruses and the development of aplastic anemia in these patients. Cells from the     samples obtained may be grown in the laboratory for future studies. Patients samples may be     used to:        -  Study abnormalities that occur in hepatitis-associated aplastic anemia;        -  Test for various viruses;        -  Test immune function;        -  Measure factors related to the patients disease or diseases they may be at risk for;        -  Evaluate the effectiveness of current therapies, refine treatment approaches, and          identify potential new therapies;        -  Identify possible measures for disease prevention;        -  Identify possible genetic factors associated with hepatitis-associated aplastic anemia.      Patients 2 years of age and older with severe aplastic anemia that developed within 6 months     of an episode of hepatitis may be eligible for this study.      Participants will complete questionnaires and provide tissue samples as described below.      Questionnaires      All patients (or another respondent for the patient) will fill out a questionnaire including     demographic information (age, gender, race, ethnic group, education level, state of     residence), current symptoms, medications, medical history, and history of possible exposures     to toxins or viruses. A second questionnaire, which includes questions related to mental     health, sexual behavior, alcohol and drug use, is optional for participants age 21 and older.     These questionnaires are designed to uncover features of hepatitis-associated aplastic anemia     and possibly reveal a common cause of the disease.      Sample Collections        -  Blood- will be collected at the time of the patient s initial evaluation or upon          enrollment into the study and possibly periodically during the study. Blood will be          drawn through a needle in an arm vein.        -  Bone marrow- may be collected as part of the patient s standard medical care or          specifically for research purposes of this study. For this procedure, the skin over the          hipbone and the outer surface of the bone itself are numbed with an injection of a local          anesthesia. Then, a larger needle is inserted into the hipbone and marrow is drawn into          a syringe. Marrow cells are suctioned two to six times during the 15-minute procedure.        -  Stool- will be provided by the patient.      Liver- tissue may be biopsied as part of the patient s general medical care or for NIH     patients, as part of their enrollment in a treatment protocol.   "
169688|NCT00050440|"     The purpose of this is to test the safety and effectiveness of an investigational     chemotherapy agent in patients with persistent or recurrent endometrial cancer.   "
169665|NCT00050128|"     This is a preliminary study to evaluate the possible use of transcranial magnetic stimulation     (TMS), together with exercise, for rehabilitation of chronic stroke patients. It will     identify the optimum stimulation settings (within the limits of current safety guidelines) to     be used in a later rehabilitation study and confirm the safety of the procedure at these     settings. Some previous studies using TMS to treat movement disorders such as Parkinson's     disease have shown improvement in motor function; others have not. The results of this study     may provide information to help researchers design better rehabilitation treatments after     stroke.      Stroke patients with residual arm function and no history of seizures may be eligible for     this study. The stroke must have occurred at least 6 months before entry into the study and     must have affected only one side of the brain.      For the TMS procedure, subjects are seated in a comfortable chair with their hands placed on     a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical     current is passed through the coil, creating a magnetic pulse that stimulates the outer part     of the brain, called the cortex. This may cause muscle, hand or arm twitching if the coil is     near the part of the brain that controls movement, or it may affect movements or reflexes.     Subjects are asked to make movements, do simple tasks, or tense muscles. Metal electrodes are     taped to the skin over the muscle for computer recording of the electrical activity of the     hand and arm muscles activated by the stimulation. The testing lasts 2-3 hours.   "
169668|NCT00050167|"     Primary Objectives:        -  Determine the impact of each regimen on the disease free and overall survival of          patients with operable breast cancer.        -  Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when          administered in the neoadjuvant setting when compared with weekly paclitaxel.        -  Determine the ability of each regimen to enhance breast conservation therapy when          administered in the neoadjuvant setting. (See protocol text for additional objectives          and details).   "
169669|NCT00050180|"     This study will examine whether a particular type of gene (MDR1) in the body can affect blood     levels of two protease inhibitors, indinavir and saquinavir, which are used to treat people     with HIV. If blood levels of these drugs are too low or too high, they may not work well or     may cause side effects in patients. This study will determine how MDR1 genes might affect     absorption of these medicines.      Healthy normal volunteers between 18 and 50 years of age may be eligible for this study.     Candidates will be screened with a medical history and blood and urine tests. The blood will     be tested for:        -  Routine laboratory values for assessing general health        -  HIV        -  MDR1 gene type        -  Amount of P-glycoprotein (a protein made by the MDR1 gene) on T cells.      Participants will have blood drawn three more times, as follows:        -  After one dose of the sedative midazolam (Versed(Registered Trademark)): Participants          will take an 8-milligram dose of midazolam syrup by mouth. Four hours later, a single          blood sample will be drawn through a needle in an arm vein. This part of the study will          assess the efficiency of a certain enzyme involved in metabolizing (breaking down)          indinavir and saquinavir.        -  After four doses of indinavir: About a week after taking the midazolam, participants          will take 800 mg of indinavir (two capsules) 3 times a day (every 8 hours) for 1 day.          The following morning they will come to the clinic, where a catheter (flexible plastic          tube) will be placed in an arm vein for repeated blood draws. A blood sample will be          drawn, and a fourth and final dose of indinavir will be given. Seven blood samples of          about a teaspoon each will then be collected through the catheter over an 8-hour period          to measure blood levels of the drug.        -  After 10 doses of saquinavir: About a week after the last dose of indinavir,          participants will start taking 1,200 mg (6 capsules) of saquinavir soft-gelatin capsules          3 times a day for 3 days. On the fourth day, participants will come to the clinic. A          catheter will be inserted into an arm vein and about 4 teaspoons of blood will be          collected for routine laboratory tests and to measure saquinavir levels. A urine sample          will also be collected for routine tests. Participants will then receive the tenth and          final dose of saquinavir, and eight blood samples of about a teaspoon each will be          collected through the catheter over an 8-hour period.   "
169670|NCT00050193|"     This study will evaluate children with mastocytosis, a disease of excessive mast cells in     tissues such as skin and bone marrow, to identify the cause of the disease and describe its     course. Mast cells can release chemicals that cause itching, blisters, flushing, bone pain,     and abdominal pain. Usually, mastocytosis in children involves the skin only and is of     limited duration. This study, however, will focus on children with more severe disease that     more closely resembles adult-onset mastocytosis.      Patients up to 21 years of age with childhood-onset mastocytosis may be eligible for this     study. Candidates must have one or more of the following abnormalities, which indicate severe     disease: enlarged liver or spleen; diffuse skin involvement; history of gastrointestinal     bleeding or peptic ulcer; bone marrow biopsy with abnormal mast cells either in number or     shape; elevated blood levels of the enzyme tryptase; or abnormal hemoglobin, white blood     cells, platelets, or clotting factors.      Participants will have a medical history and physical examination; various blood tests,     including studies to identify genetic changes that are important in the growth, development,     and functioning of human mast cells; and bone marrow aspiration and biopsy. For the bone     marrow procedure, the skin over the hipbone and the outer surface of the bone itself are     numbed with an injection of local anesthesia. Then, a special needle is inserted into the     hipbone and about 2 tablespoons of bone marrow are drawn into a syringe. Another needle is     then inserted through the first needle to collect a small piece of the bone marrow. Pain will     be managed according to the individual patient s needs. Additional procedures, such as a     gastroenterology consultation, colonoscopy to examine the colon, or computerized axial     tomography (CT) or ultrasound of the abdomen to assess the liver and spleen, may be done if     medically indicated. Standard medical treatment, including antihistamines for itching or     steroids for abdominal cramping or diarrhea, will be recommended as appropriate.      Patients biologic parents may also be enrolled to provide a blood sample for genetic analysis     and a bone marrow aspirate and biopsy for clinical and research purposes.      Patients will return to NIH once a year for follow-up evaluations until their disease is     stable or until the 5-year study ends.   "
169671|NCT00050206|"     The purpose of this study is to determine the efficacy (how well the drug works), safety, and     any side effects of olanzapine compared to placebo in the treatment of mania in bipolar     disorder in adolescents. Both the potential benefits and side effects of olanzapine will be     evaluated throughout this trial.   "
169672|NCT00050219|"     This study will examine the role of the brain chemical dopamine in people's response to     alcohol consumption. Dopamine is thought to influence whether people have a strong or weak     response to alcohol and how pleasurable that response is. The findings of this study may shed     light on why some people are at higher risk of developing problem drinking behaviors.      Healthy normal volunteers between 21 and 25 years of age who have never had a serious problem     with alcohol abuse or drug abuse may be eligible for this study. Candidates will be screened     with a medical history and physical examination, and will be interviewed about their smoking     and drinking behaviors. Participants will undergo test procedures on two separate days, as     follows:      Test Day 1      Upon arrival at the Clinical Center, participants will take a breathalyzer test for alcohol     and provide a urine sample for a drug screen. Women will also have a urine pregnancy test.     They will then lie on a hospital bed and two intravenous catheters (IV lines) will be placed,     one into each arm. One line will be used to collect blood samples during the test session;     the other will be used to infuse alcohol into the bloodstream. The alcohol will rapidly     increase the blood alcohol level to between 0.06 and 0.08 grams per deciliter. (0.08 g/dL is     the level at which a person is charge with driving under the influence of alcohol in all     States.) Before, during, and after the infusion, subjects will be asked about their feelings     in response to the alcohol, such as confusion, elation, level of discomfort or dizziness,     ability to concentrate, and so forth. At 35 and 60 minutes after the infusion begins,     subjects will take a body sway test. This involves standing on a machine to determine how the     alcohol has affected the sense of balance. Subjects will then relax in the clinic for a few     hours. During this time, a blood sample will be collected and a questionnaire will be given     hourly until the blood alcohol level has gone down to 0.02 g/dL. When the alcohol level has     declined to 0.02 g/dL (usually 3 to 4 hours after the infusion), the subject will be sent     home in a taxi.      Test Day 2      Participants will again take a breathalyzer test for alcohol and provide a urine sample for     drug screen and, for women, a pregnancy test. Subjects will lie on a hospital bed and three     IV lines will be inserted, one to draw blood samples, one to infuse alcohol, and one to give     raclopride, a radioactive substance used for positron emission tomography (PET) scanning. For     PET, the subject lies on a table in the scanner with a mask placed over his or her head to     help hold the head still during the scan. After a brief scan to adjust the machine, a small     amount of radioactive water (O-15 water) is injected through the IV line and a series of     pictures is taken over a period of about 1 minute. These images show how the radioactive     water distributes in the brain, indicating blood flow. After the water scan, raclopride is     given through the IV line and more pictures of the brain are taken over the next 2 hours.     Blood samples are collected during and after the raclopride scan. During this procedure,     subjects are asked the same questions about their feelings in response to the alcohol as they     did during the earlier session. After he scans, they will be monitored in the clinic with     hourly blood tests and questionnaires until the blood alcohol concentration decreases to 0.02     g/dL and will then be sent home in a taxi.   "
169673|NCT00050232|"     Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying     out of proportion. Other terms used to describe this condition include emotional lability,     emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and     pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the     reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923     in the treatment of MS patients suffering from pseudobulbar affect.   "
169725|NCT00050960|"     This study evaluates the use of Targretin capsules (bexarotene) in combination with standard     chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients     who have not yet received chemotherapy for their lung cancer.   "
169674|NCT00050245|"     This study will test the safety and effectiveness of the drug Rituximab in treating a nerve     disease called MGUS (also known as neuropathy with anti-MAG antibodies). Patients with MGUS     have an abnormal protein called monoclonal IgM immunoglobulin that attacks the myelin sheath     (protective coating) of nerves, causing them to not function properly. The disease affects     the nerves in the legs or arms, and patients have numbness, tingling, muscle weakness, and     unsteady gait. There are no adequate treatments. Immunosuppressive drugs or human     immunoglobulin infusions can produce mild and transient improvement, but the benefits of     these therapies are not significant.      The abnormal immunoglobulin protein in MGUS is produced by white cells called B lymphocytes.     Rituximab is approved to treat B cell lymphomas. Also, the drug showed promise in a recent     study of patients with demyelinating neuropathy associated with production of antibodies from     B lymphocytes directed against certain nerve proteins. Although the number of patients     treated with Rituximab was small, the drug was well tolerated and caused significant     improvement in several of the patients.      Patients 25 years of age and older with MGUS may be eligible for this 2-year study.     Candidates will be screened with a medical history, physical and neurological examinations,     and blood tests.      Participants will be randomly assigned to receive intravenous (through a vein) infusions of     either Rituximab or placebo (a solution that looks like Rituximab but has no active     ingredient) once a week for 4 consecutive weeks. In addition, they will undergo the following     tests and procedures:        -  Monthly follow-up visits following Rituximab treatment for repeat physical and          neurological examinations, blood tests, muscle strength measurements, and review of          signs and symptoms.        -  Two sessions of lymphapheresis, one at the beginning of the study and one a year          later-to collect lymphocytes. For this procedure, whole blood is drawn through a needle          in an arm vein, much like donating a unit of blood. The blood then flows through a          catheter (plastic tube) into a cell separating machine, where the white blood cells are          extracted and removed. The red cells and plasma are then returned to the body through a          needle in the other arm. The procedure takes about 60 to 90 minutes.        -  Electrophysiologic studies (electromyography and nerve conduction testing) are done once          at the beginning of the study and again one year later. For electromyography, a small          needle is inserted into a few muscles and the patient is asked to relax or to contract          the muscles. The electrical activity of the muscle cells is recorded and analyzed by a          computer. For nerve conduction testing, nerves are stimulated through small wire          electrodes attached to the skin and the response is recorded and analyzed.      If this study indicates that Rituximab is beneficial against MGUS, patients who were assigned     to receive placebo during the trial will be offered treatment with Rituximab (four weekly     infusions) at the end of the study.   "
169675|NCT00050271|"     The purpose of this study is to determine if acetyl-L-carnitine (ALC) reduces pain, numbness,     and tingling in the feet and legs of patients with nucleoside reverse transcriptase inhibitor     (NRTI)-associated peripheral neuropathy. Another purpose is to determine if ALC is safe and     tolerable in HIV patients who have taken certain anti-HIV drugs.   "
169677|NCT00050297|"     The purpose of this study is to determine the optimal dosage of YM598 for slowing down     disease progression in patients with rising PSA after initial therapy for localized prostate     cancer.   "
169678|NCT00050310|"     This study will examine pathophysiology and immune response of anthrax in infected or exposed     individuals to learn more about the disease symptoms, prevention and response to treatment.     In addition, it will evaluate immune response to the anthrax vaccine AVA (Anthrax Vaccine     Adsorbed) in healthy, non-infected individuals.      The following individuals may be eligible for this study:        1. People with confirmed or suspected anthrax (inhalational, cutaneous or gastrointestinal,          either acute or recovering);        2. People exposed to anthrax who have no clinical symptoms.        3. Healthy people who have not been exposed to anthrax and have been vaccinated with AVA.      Those enrolled in the study will undergo the following tests and procedures.      Infected and exposed individuals:        -  Symptomatic participants will have the following clinical procedures if medically          necessary:        -  a) blood tests for cell counts, chemistries and evidence of anthrax bacteria;        -  b) nasal swab to test for evidence of anthrax        -  c) chest X-ray;        -  d) computed tomography (CT) scan (special X-rays to examine the lungs or abdomen);        -  e) echocardiogram to examine the heart        -  f) magnetic resonance imaging (MRI), a special imaging test using a magnetic field and          radio waves to examine the infected area of skin and soft tissue for patients with          cutaneous anthrax.        -  All subjects (with or without symptoms) will have the following research procedures:        -  a) blood tests to examine immune response to anthrax;        -  b) throat swab to test for evidence of anthrax        -  c) nasopharyngeal wash to test for anthrax. Water is sprayed into the nostrils and then          allowed to drain for collection in a cup;        -  d) induced sputum to test for presence of and immune response to anthrax. A mask with a          saline mist is placed over the subject s mouth and nose, causing the subject to cough          and produce sputum from the lungs. The sputum is collected in a cup this is for          individuals 18 and older who do not undergo bronchoscopy, described below.        -  Participants 18 years of age and older may have the following optional research          procedures:        -  a) leukapheresis or plasmapheresis (see description under non-infected, vaccinated          individuals above);        -  b) lymph node biopsy. A sample of lymph node tissue is surgically removed under local          anesthetic;        -  c) bronchoalveolar lavage. This 15- to 30-minute procedure is done in the intensive care          unit. The mouth, nasal passages, throat and airways are numbed with lidocaine and a thin          flexible tube is passed through the nose into the lung airways. Samples of cells and          secretions are obtained by rinsing (lavage) the airways with salt water. The fluid is          analyzed for infection, inflammatory cells and inflammatory chemicals.      All infected and exposed individuals will have periodic medical history and physical exam     evaluations and be offered treatment or prophylaxis (treatment to prevent infection) with     antibiotics, according to the guidelines of the Centers for Disease Control and Prevention     (CDC). Patients will be monitored for at least 24 months after antibiotic treatment, or     longer if circumstances warrant.      Non-infected, vaccinated individuals        1. medical history and physical examination        2. blood tests-- between 10 and 50 ml (2-10 teaspoons) of blood will be drawn at a time,          and not more than 450 ml will be taken in a 6-week period. Based on the blood test          results, other optional research procedures may be requested        3. leukapheresis to collect white blood cells and plasmapheresis to collect plasma (the          liquid part of the blood). For both of these procedures, blood is collected through a          needle placed in an arm vein. The blood flows into a special machine that separates it          into its components by spinning. The desired components (white cells or plasma) are          removed and the rest of the blood is returned to the body through the same needle or a          second needle in the other arm.   "
169679|NCT00050323|"     The primary purpose of this study is to determine the safety of injections prepared from     donor blood cells fused to a patient's own tumor cells which are then used to treat advanced     (Stage IV) kidney cancer (renal cell carcinoma or RCC). The study will also explore the     effect the injections have on the size of the tumor and the response in the patient's immune     system following administration.   "
169680|NCT00050336|"     The purpose of this study is to determine the overall survival of patients diagnosed with     Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein     Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin     with that of patients treated with placebo in combination with paclitaxel and carboplatin.   "
169681|NCT00050349|"     This study will examine whether the new investigational drug EPO906, given by intravenous     infusion (IV directly into the vein), is effective in shrinking tumors and preventing the     growth of cells that cause metastatic carcinoid and other neuroendocrine tumors.   "
169682|NCT00050362|"     This study will evaluate the ability of the drugs rofecoxib and bupivacaine to prevent pain     following third molar (wisdom tooth) extraction. Rofecoxib is approved to treat pain of     arthritis and menstrual cramps. Bupivacaine is a local anesthetic similar to lidocaine, but     longer acting.      Healthy normal volunteers between 16 and 35 years of age who are in general good health and     require extraction of their two lower wisdom teeth may be eligible for this study.      Participants will have their two lower wisdom teeth extracted, and a biopsy (removal of a     small piece of tissue) will be taken from the inside of the cheek around the area behind one     of the extraction sites. Ninety minutes before surgery, patients will take a dose of either     rofecoxib, or a placebo (a pill with no active ingredient) by mouth. Just before surgery,     they will receive an injection of either lidocaine or bupivacaine to numb the mouth and a     sedative called midazolam (Versed® (Registered Trademark)) through an arm vein to cause     drowsiness. After surgery, a small piece of tubing will be placed into one of the two     extraction sites. Samples will be collected from the tubing to measure chemicals involved in     pain and inflammation.      Patients will remain in the clinic for up to 4 hours after surgery to monitor pain and drug     side effects while the anesthetic wears off. During this time, they will complete pain     questionnaires every 20 minutes. (Patients whose pain is unrelieved an hour after surgery may     request and receive acetaminophen (Tylenol) and codeine.) The tubing then will be removed and     they will be discharged with pain medicines (Tylenol, codeine and the study drug) and forms     to record pain ratings. They will be given detailed instructions on how and when to take the     medicines and how to record information in the pain diary.      Patients will return to the clinic 48 hours after surgery with the pain diary and pain     relievers. At this visit, another biopsy will be taken under local anesthetic (lidocaine).   "
169683|NCT00050375|"     This study will compare the time to disease relapse between OvaRex® MAb-B43.13-treated     patients and placebo-treated patients. This study will also compare assessments of survival,     quality of life, immune response and safety between active and placebo groups.   "
169684|NCT00050388|"     The purpose of this clinical trial is to determine if Allovectin-7®, an experimental     gene-based immunotherapy, can shrink head and neck tumors. The trial will also examine if     treatment can boost the immune system and if this treatment can improve the time to disease     progression.   "
169686|NCT00050414|"     The purpose of this study is to test the safety and effectiveness of an investigational     chemotherapy agent in patients with advanced ovarian cancer.   "
169687|NCT00050427|"     The purpose of this study is to test the safety and effectiveness of an investigational     chemotherapy agent in patients with advanced breast cancer.   "
169689|NCT00050466|"     This pilot study will examine the usefulness of a new instrument called the Dynamic Light     Scattering (DLS) device for documenting and monitoring changes in the cornea, the front part     of the eye where contact lenses are placed. The DLS device uses a low-intensity laser similar     to that used in supermarket checkouts to measure the cloudiness of the cornea. The results of     this study may lead to further investigations using DLS to discover the cause of corneal     clouding and to develop treatments to prevent it.      Healthy volunteers and patients with corneal clouding or opacification 18 years of age and     older may be eligible for this study.      Participants will have a standard eye examination, including a check of visual acuity and eye     pressure. The retina will also be examined and photographs of the cornea may be taken. For     the DLS test, the subject sits in front of the device and looks at a yellow-green target     while the cloudiness of the cornea is measured. Subjects will be tested four times. The     entire procedure takes less than 30 minutes.   "
169690|NCT00050479|"     This study will compare the side effects of two laser treatments for diabetic macular edema,     a common condition in patients with diabetes. In macular edema, blood vessels in the retina,     a thin layer of tissue that lines the back of the eye become leaky and the retina swells. The     macula, the center part of the retina that is responsible for fine vision may also swell,     causing vision loss. Traditional laser treatment (argon blue or green or yellow) for macular     swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision.     Studies with a different type of laser (diode) may be less damaging. The results of this     study on side effects of the treatments will be used to design a larger study of     effectiveness. This study will also examine whether celecoxib (Celebrex® (Registered     Trademark)), an anti-arthritis drug that reduces inflammation and swelling, can reduce     inflammation and swelling of the retina. Patients with elevated cholesterol levels will be     invited to participate in a cholesterol reduction part of the study to compare normal-pace     cholesterol reduction with accelerated reduction.      Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema that     requires laser treatment may be eligible for this study. Candidates will be screened with the     following tests and procedures:        -  Medical history: to review past medical conditions and treatments.        -  Physical examination: to measure vital signs (pulse, blood pressure, temperature,          breathing rate) and examine the head and neck, heart, lungs, abdomen, arms and legs.        -  Eye examination: to assess visual acuity (eye chart test) and examine pupils, lens,          retina, and eye movements. The pupils will be dilated with drops for this examination.        -  Blood tests: to measure cholesterol, blood clotting time, hemoglobin A1C (a measure of          diabetes control), and to evaluate liver and kidney function.        -  Eye photography: to help evaluate the status of the retina and changes that may occur in          the future. Special photographs of the inside of the eye are taken using a camera that          flashes a bright light into the eye. From 2 to 20 pictures may be taken, depending on          the eye condition.        -  Fluorescein angiography: to evaluate the eye's blood vessels. A yellow dye is injected          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina          are taken using a camera that flashes a blue light into the eye. The pictures show if          any dye has leaked from the vessels into the retina, indicating possible blood vessel          abnormality.      Participants will be randomly assigned to take celecoxib or placebo (an inactive, look-alike     pill). Participants who have elevated cholesterol levels may return for a brief visit after 1     month. All patients will return for follow-up visits at 3, 6, and 12 months. Patients who     require laser treatment will be randomly assigned to one of the two laser treatments. For     these procedures, eye drops are put in the eye to numb the surface and a contact lens is     placed on the eye during the laser beam application. Several visits may be required for     additional laser treatments. The maximum number of treatments depends on how well the     treatment is working. Patients who respond well to the study medication may receive no laser     treatments. After the first year, patients will be followed every 6 months until either the     patient returns for a 3-year visit, the last enrolled patient returns for the 1-year visit,     or the patient requests to leave the study. During the follow-up visits, patients' response     to treatment will be evaluated with repeat tests of several of the screening exams.   "
169691|NCT00050492|"     This study will look for biological markers of primary retinal vasculitis that can be useful     in understanding what causes the disease. It will evaluate its progression, and develop and     monitor treatments. Biological markers are substances (e.g., chemicals called cytokines and     chemokines or antibodies) that are associated with a disease or condition such as retinal     vasculitis. Retinal vasculitis is an inflammation of blood vessels in the retina that can     cause retinal damage and subsequent loss of vision. It can occur by itself (primary retinal     vasculitis), or it can be part of a systemic vascular disease.      The study will evaluate patients with primary retinal vasculitis and compare the findings     with those of two other groups of patients with retinal vasculitis patients with Behcet's     syndrome and HIV-infected patients undergoing HAART therapy.      Patients over 10 years of age with sight-threatening retinal vasculitis may be eligible for     this study. (page 6 of the protocol, under #4 Study Design and Methods, says the age range is     2 years old and above; page 10, under #5 Participant Inclusion and Exclusion Criteria, says     initial enrollment will include all patients over the age of 10 years).      Upon entering the study, participants will have about 10 teaspoons of blood withdrawn from an     arm vein through a needle and again 6 months and 12 months later. The blood samples will be     analyzed for cytokines, chemokines or adhesion molecules, certain types of antibodies, and     infectious agents.   "
169692|NCT00050505|"     The purpose of this study is to determine the safety and effect of diluting smallpox vaccine,     making a larger number of doses in case smallpox is released into the environment. A total of     up to 927 healthy adults between the ages of 32 and 70 years who were already vaccinated     against smallpox (but not since 1989) will volunteer for this study for up to 34 weeks and     receive different strengths of vaccine. Some subjects may participate for longer if they     choose to be revaccinated because the first vaccination does not take. The vaccine will be     given by making small cuts in the skin and putting the vaccine into these cuts. After the     screening visit, volunteers will be followed through study visits and follow up phone calls.     Blood will be collected during some study visits to look at the immune system (body system     that fights infection) response.   "
169968|NCT00054574|"     RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them     or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of ABX-EGF in treating patients who have     prostate cancer that has not responded to hormone therapy.   "
169693|NCT00050518|"     The study seeks to define, with precision, the safety and efficacy of APSV, two dose     potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a     classic �take� as defined by formation of a lesion at the injection site consistent with the     �Jennerian� process (see Appendix A) and vaccine specific immune responses will be assessed.     The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of     live, replicating smallpox vaccines. Neutralizing antibody formation has been correlated with     takes for the Dryvax vaccine and is considered to be cross-protective for other     orthopoxviruses, including variola. The study also seeks to characterize preliminarily the     cell mediated immune (CMI) response to APSV (as compared to Dryvax).   "
169694|NCT00050531|"     The goal of this clinical research study is to learn if giving PEG-Alpha Interferon     (PEG-Intron) and Sargramostim (GM-CSF) to patients receiving treatment with high dose Gleevec     (imatinib mesylate) is more effective in treating CML in chronic phase than therapy with     imatinib mesylate alone.   "
169695|NCT00050557|"     The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation     Group for the families of children with mood disorders.   "
169696|NCT00050570|"     The purpose of this study is to determine whether a web-based program is effective in     reducing the incidence of eating disorders in college women who are at high risk for     developing an eating disorder.   "
169697|NCT00050583|"     The purpose of this study is to compare cognitive behavior therapy (CBT) to medical     care-as-usual for the treatment of patients with high levels of medically unexplained     physical symptoms (Somatization Disorder). A second goal is to examine the effectiveness of     CBT in Latinos, since Latinos suffer a relatively high prevalence of Somatization Disorder.   "
169698|NCT00050596|"     The primary objectives of the study are to determine the safety and activity of multiple     doses of MDX-010 in patients with hormone-refractory prostate cancer (HRPC), and to determine     the safety and activity profile of a single dose of cytotoxic chemotherapy (docetaxel) in     combination with MDX-010   "
169699|NCT00050609|"     The purposes of this study are to determine whether an experimental drug known as tadalafil     can reduce symptoms of dyspepsia (fullness after eating, inability to finish a regular meal,     bloating, discomfort or pain in the upper abdomen, belching after meals, nausea, vomiting) in     diabetic patients, and/or reduce the amount of time the stomach takes to empty the contents     of a standard meal. The safety of tadalafil given once daily for 8 weeks in this population     will also be studied.   "
169700|NCT00050622|"     The purpose of this study is to determine the effectiveness of behavioral treatment, drug     treatment, and combined treatment for children with Attention Deficit Hyperactivity Disorder     (ADHD). This study will also examine the interactions between different levels of behavioral     and drug treatments.   "
169711|NCT00050778|"     This was a Phase II, randomized, open-label, rater-blinded, three-arm study comparing two     different doses of alemtuzumab (Lemtrada™) and one dose of subcutaneous (SC) interferon     beta-1a (Rebif®) in participants with early, active relapsing-remitting multiple sclerosis     (MS) who had not been previously treated with MS therapies other than steroids. The study was     conducted for an initial period of 3 years and a follow-up to 5 years or more.   "
169701|NCT00050635|"     Currently there is an ongoing clinical trial for patients with chemotherapy induced diarrhea.     This trial is being conducted to evaluate the efficacy of two dose levels (30 mg and 40 mg)     of an investigational drug in reducing the occurrence of severe (Grade 3 or 4) diarrhea     during chemotherapy. Eligible patients must either have experienced NCI Common Toxicity Grade     1 - 4 chemotherapy-induced diarrhea during previous chemotherapy treatment or be experiencing     Grade 1-4 chemotherapy-induced diarrhea currently.      In order to participate in this clinical trial, patients must be male or female 18 years of     age or older. Inclusion into this investigational drug trial is based on the protocol entry     criteria and a detailed evaluation from a participating trial investigator   "
169702|NCT00050648|"     This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab)     and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed     study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and     Cyclosporine.   "
169703|NCT00050661|"     This study is designed to study disease relapse after NBUVB and how the administration of     Daclizumab/placebo alters disease relapse.   "
169704|NCT00050674|"     Determine whether patients have a decreased incidence of grade 3 and grade 4 neutropenia when     Filgrastim-SD/01 is given with docetaxel and gemcitabine in patients with advanced non-small     cell lung cancer.   "
169705|NCT00050687|"     This study will test the safety, tolerance, and efficacy of different doses of oral gallium     maltolate. Patients will receive oral gallium maltolate twice daily for 28-consecutive days     followed by 14 days off treatment. This dosing cycle will be repeated. Adverse effects will     be assessed and the levels of gallium in serum will be measured. Any effect of the drug on     the cancer and any improvement in cancer-related symptoms will also be measured.   "
169706|NCT00050700|"     The purpose of this study is to use brain imaging technology to examine the role of certain     brain receptors and the nervous system chemical acetylcholine in major depression.      The cholinergic system involves the regulation of neurotransmitters and the brain receptors     to which they bind. Evidence suggests that the cholinergic system may play a role in the     development of depression. Acetylcholine is a neurotransmitter that binds to certain brain     receptors called muscarinic cholinergic receptors. Cholinomimetic drugs (drugs that stimulate     the cholinergic system) often exacerbate depressive symptoms in people with mood disorders     and in healthy individuals. This increase in depressive symptoms may be caused by stimulation     of muscarinic acetylcholine receptors (mAChRs), but further study is needed to confirm this.     This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI)     to study the function of mAChRs in individuals with depression.      Participants in this study will undergo a physical examination, psychiatric interviews,     neuropsychological tests, PET and MRI scans, and rating scales of depression, anxiety, and     negative thinking symptoms. Questions about behavior and functioning will be asked and blood     samples will be collected for genetic analysis.   "
169707|NCT00050713|"     This study will evaluate the safety and effectiveness of a new immunosuppressive drug,     sirolimus, in reducing the amount of protein in the urine in patients with membranous     nephropathy. This condition involves damage to the walls of tiny blood vessel filters in the     kidneys called glomeruli, which allows blood proteins to leak into the urine. Patients have     low blood protein levels and high blood cholesterol. Some patients may have leg swelling,     impaired kidney function, blood vessel and heart disease, and a risk of emboli (blood clots     that travel to the lungs). Drugs currently used to treat membranous nephropathy vary in their     effectiveness among patients and can cause severe side effects.      The Food and Drug Administration has approved sirolimus for suppressing the immune system of     patients who have had a kidney transplant to reduce the risk of organ rejection. The drug     does not have certain side effects that have caused problems for patients treated with other     immunosuppressants, such as: prednisone (weight gain, round face, diabetes, weak and     fractured bones, and cataracts); cyclophosphamide (fertility problems, bladder injury and     bladder cancer, and other cancers); chlorambucil (fertility problems, seizures, acute     leukemia, and other cancers); and cyclosporine (kidney toxicity, increased facial hair, and     seizures).      Patients 13 years of age or older with idiopathic membranous nephropathy or lupus membranous     nephropathy may be eligible for this study. Candidates must have completed at least one month     of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or     angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical     examination, blood tests, skin test for exposure to tuberculosis, and an examination for     infection, cancers, and other conditions that can cause membranous nephropathy.      Participants will take sirolimus once a day for 1 year, except for the first day of     treatment, when they will take three doses to quickly bring their blood levels of the drug up     to a therapeutic level. They will undergo evaluations at the NIH in Bethesda, Maryland, at     baseline (before starting treatment) and again at 1- to 4-month intervals during the study.     In addition, they will have blood tests every week for the first month and every 2 weeks for     the second month; then blood and urine tests once a month for the next 10 months of treatment     and then every 4 months for a 12-month period after treatment stops. These tests will     evaluate drug side effects and the response to therapy, and will determine if the therapeutic     benefits persist long-term when treatment stops.      Patients will also be asked to have optional kidney function tests during the baseline     evaluation and at the end of the follow-up period to measure kidney filtration and blood flow     rates. Those who participate will be given fluids and other substances by vein to accurately     measure kidney function. They will then have blood and urine samples collected about four     times over a 1-hour period after drinking fluids to increase urine output.      Patients who experience a substantial increase in proteinuria or substantial decrease in     kidney function during the course of treatment will stop taking sirolimus and be taken off     the study.   "
169979|NCT00054717|"     Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment     regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected     patients.   "
169708|NCT00050726|"     This investigation is a sub-study of the 6-year multinational ESPRIT (Evaluation of     Subcutaneous Proleukin in a Randomized International Trial) protocol. It will compare the     effectiveness of the influenza (FLUVAC) and tetanus-pneumococcal (TEPVAC) vaccines in     HIV-infected patients receiving interleukin-2 (IL-2) plus anti-HIV drugs with those receiving     only anti-HIV drugs. IL-2 is a protein naturally produced by immune cells called lymphocytes.     Lymphocytes from patients with HIV do not produce IL-2 normally. The ESPRIT trial is     evaluating whether HIV-infected patients treated with antiretroviral drugs plus IL-2 have     fewer serious infections and improved survival than those receiving only anti-HIV drugs.      Participants in this sub-study will be drawn from patients enrolled in ESPRIT. They must be     18 years of age or older, have HIV infection with no symptoms of significant HIV illness.     They will be vaccinated against either influenza or tetanus and pneumococcus, as follows:      FLUVAC      Potentially eligible patients will be screened for the FLUVAC study during an ESPRIT     follow-up visit. Those who are eligible and agree to participate will have 10 ml (1     tablespoon) of blood drawn to assess baseline antibody levels and then receive the     vaccination. They will be vaccinated annually for 3 years. A blood sample (10 ml) will be     drawn 1 month after each vaccination to measure the immune response. Some of the blood drawn     for this study will be stored and used for research purposes.      TEPVAC      Participants will have 10 ml of blood drawn to assess their baseline antibody levels. They     will receive two vaccinations (tetanus and pneumococcus) 12 months after enrolling in ESPRIT     and another two vaccinations 24 months after enrollment. A blood sample (10 ml) will be drawn     1 month after each vaccination to measure the immune response. Some of the blood drawn for     this study will be stored and used for research purposes.   "
169709|NCT00050752|"     This study will investigate what causes hereditary leiomyomatosis renal (kidney) cell cancer,     or HLRCC, and how the disease is related to the development of kidney tumors. Leiomyomas are     benign (non-cancerous) tumors arising from smooth muscle. HLRCC can cause various health     problems. Some people develop red bumps on their skin that can be painful at times. Some     women with HLRCC can develop leiomyomas of the uterus. In some families, people with HLRCC     develop kidney tumors. This study will try to determine:        -  What gene changes (mutations) cause HLRCC        -  What kind of kidney tumors develop in HLRCC and how they grow        -  What the chance is that a person with HLRCC will develop a kidney tumor      People with known or suspected HLRCC (and their family members of any age) may be eligible     for this study. This includes people in families in which one or more members has skin     leiomyoma and kidney cancer; skin leiomyoma and uterine leiomyoma; multiple skin leiomyomas;     kidney cancer and uterine leiomyomas, or kidney cancer consistent with HLRCC, including, but     not limited to, collecting duct or papillary, type II. Candidates will be screened with a     physical examination, family history, and, for affected family members, a review of medical     records, including pathology slides and computed tomography (CT) or magnetic resonance     imaging (MRI) scans.      Participants will undergo tests and procedures that may include the following:        -  Review of medical records, x-rays, and tissue slides        -  Physical examination and family history        -  Skin examination        -  Gynecological examination for women        -  Interviews with a cancer doctor, cancer nurses, kidney surgeon, and genetic counselor        -  Blood tests for:             1. Genetic research to identify the gene responsible for HLRCC             2. Evaluation of liver, kidney, heart, pancreas, and thyroid function             3. Complete blood count and clotting profile             4. Pregnancy test for pre-menopausal women             5. PSA test for prostate cancer in men over age 40        -  CT or MRI scans (for participants 15 years of age and older only)        -  Skin biopsy (surgical removal of a small sample of skin tissue)        -  Cheek swab or mouth rinse to collect cells for genetic analysis        -  Medical photographs of lesions        -  Questionnaire      When the tests are completed, participants will discuss the results with a doctor and     possibly a genetic nurse or genetic counselor. The genetic findings will not be revealed to     participants because their meaning and implications may not yet be understood. Participants     may be asked to return to NIH from every 3 months to every 3 years, depending on their     condition, for follow-up examinations and tests.   "
169710|NCT00050765|"     MyoCell™ implantation by epicardial injection during CABG surgery has the potential to add a     new dimension to the management of post-infarct deterioration of cardiac function. Based on     existing non-clinical studies and clinical reports, implantation of autologous skeletal     myoblasts appears to lead to the replacement of non-functioning myocardial scar with     functioning muscle and appears to improve myocardial performance relative to case without     myoblast implantation. In a few investigational patients, myoblast implantation can be, and     has been, done in conjunction with CABG and appears to have the potential to provide for     additive treatment during surgery. The present study is being conducted to evaluate more     fully the safety of MyoCell™ implantation via epicardial injection during CABG surgery and     its effect on regional myocardial function.   "
169712|NCT00050791|"     This is a double blind placebo controlled clinical study designed to determine the effects of     leptin on the changes that occur in the body during weight loss achieved by a very low     calorie diet.   "
169713|NCT00050804|"     The purpose of this study is to examine the short-term consequences of trauma and to     determine the effectiveness of the drug sertraline in preventing and treating post-traumatic     stress disorder (PTSD) and acute stress disorder (ASD) symptoms.      ASD and PTSD are common consequences of exposure to traumatic events. Despite growing     evidence of neurobiological dysfunction in ASD and PTSD, the origin of these disorders is     still unknown. This study will attempt to identify psychophysiological markers of ASD and     find an effective treatment for its symptoms.      Victims of serious motor vehicle collisions will be evaluated with clinical assessments and     standardized questionnaires within 2 weeks after the accident. Symptoms of exaggerated     startle, emotional reactivity to trauma-related and trauma-unrelated cues, and cerebellum     functioning will be evaluated. Participants will be randomized to receive either sertraline     or placebo (an inactive sugar pill) for 8 weeks. Psychometric testing and psychological     evaluations will be conducted 4, 10, and 14 weeks after the accident and after a 2-week taper     of the study medication.   "
169714|NCT00050817|"     RATIONALE:        -  Atherothrombosis is a progressive and generalized vascular disease resulting in events          leading to myocardial infarction (heart attack), stroke, and vascular death.        -  In patients at risk for this disease, it is characterized by an unpredictable, sudden          disruption of atherosclerotic plaques, which may lead to total occlusion of artery due          to formation of a clot. The use of aspirin (blood thinner agent) for reducing those          major ischemic events is either indicated, or recommended by international guidelines.          However, aspirin fails to prevent a high percentage of such life-threatening events.          Therefore, more effective blood thinning therapy may provide additional clinical benefit          to such patients.        -  The results of the CURE trial in patients with unstable angina demonstrate the          additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood          thinner agent), when administered in combination with standard therapy including          aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of          clopidogrel may apply to a broad population of high-risk patients receiving low-dose          aspirin therapy. Such population includes patients with previous cardiovascular,          neurovascular or peripheral arterial manifestations of atherothrombosis and patients          with combinations of recognized risk factors for atherosclerosis.      OBJECTIVES:        -  To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in          preventing cardiovascular morbidity/mortality. The study will compare the efficacy of          the two regimens in preventing the occurrence of major cardiovascular complications          (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise          receiving low-dose aspirin therapy (75-162 mg daily).        -  To evaluate the safety of clopidogrel in this population, and more specifically the          incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate          the global benefit of clopidogrel in this patient population.   "
169715|NCT00050830|"     The purpose of study to determine the activity of CI 1033 against tumors in patients with     advanced or metastatic NSCLC who have failed prior platinum-based combination chemotherapy.     Another objective is to determine the safety of CI 1033.   "
169716|NCT00050843|"     The primary objective of the study is to determine the efficacy of thalidomide for the     treatment of anemia in patients with myelodysplastic syndromes (MDS).   "
169746|NCT00058903|"     The goal of this study is to find an effective and well-tolerated medical therapy for itching     due to liver disease. Persons with primary biliary cirrhosis or chronic hepatitis C are     currently being enrolled in the study. Persons participating in the study are given     sertraline, a medication which is also often used for depression,to treat their itching. The     dose is gradually increased as the effect on itching and any other potential side effects are     carefully monitored.   "
169717|NCT00050856|"     This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together     with other treatments for HIV infection in patients with advanced HIV disease. Fuzeon is an     antiretroviral drug. Unlike other antiretrovirals, however, which work against the virus once     it is already in the cell, Fuzeon prevents the virus from getting into healthy cells.      Patients 18 years of age and older with advanced HIV-1 infection, who do not respond to     approved antiretroviral therapy, may be eligible for this study. Candidates must have a CD4     lymphocyte count less than 100 cells/mm3 and a viral load greater than 10,000 copies/mL. They     will be screened with a medical history, physical examination, and blood tests, and may also     have an electrocardiogram (ECG), chest x-ray and urine test.      Patients enrolled in the study will be re-examined and have additional blood tests before     beginning treatment with Fuzeon. They will then be taught how to self-inject the medicine     under the skin and will take two doses daily (less than 1/4 teaspoon each), 12 hours apart.     After the first treatment, participants will have follow-up visits at weeks 1, 2, 4, 8, 12,     24, 36, 48, and every 12 weeks after that, if necessary, until 12 weeks after the drug     becomes commercially available. Visits may be scheduled more often if a problem arises.     During the follow-up visits, patients will have blood drawn, and their blood pressure, pulse     rate and temperature will be checked. They will also report any drug side effects they have     experienced.      Patients may continue to take Fuzeon as long as they benefit from therapy and do not     experience severe side effects from the treatment. The drug will be provided to participants     until 12 weeks after it is sold in the United States.   "
169718|NCT00050869|"     Motor training results in use dependent plasticity (UDP), thought to underlie recovery of     motor function after brain injury. The purpose of this protocol is to determine (a) if     movement observation results in encoding of a motor memory in the primary motor cortex and     (b) if observation of motor training can enhance the effects of physical training in healthy     volunteers. If so, this may become an important tool in rehabilitative treatment for patients     who are unable or partially able to train. We will test our hypotheses by means of focal     single pulse transcranial magnetic stimulation (TMS) in a group of healthy volunteers. Our     outcome measure will be the change in TMS-evoked movement direction as a function of training     strategy. So far we found that this is the case in healthy volunteers (see data in analysis     of the study). The purpose of this amendment is to determine if action observation can elicit     the same effects in adult chronic ischemic stroke patients who have had originally     significant motor weakness but recovered to the point of being able to perform the motor     tasks, possibly resulting in a useful rehabilitative strategy.   "
169719|NCT00050882|"     This study is intended to evaluate the potential to relieve the symptoms associated with     gastroparesis during 12 weeks of treatment with oral tablets given twice a day of GM-611 5mg,     10mg or placebo to type I or II diabetics who require insulin.      Additionally the study will evaluate the safety and tolerability of GM-611 compared to     placebo, the levels of GM-611 in the blood, and the possible effect of GM-611 on diabetic     control.   "
169720|NCT00050895|"     With new strategies and drugs available, many different regimens exist for the treatment of     HIV. The purpose of this study is to compare three different anti-HIV drug regimens as     first-time treatments for HIV infection.   "
169721|NCT00050908|"     This is a substudy of ACTG A5142. The purpose of this substudy is to evaluate blood vessel     function in HIV-infected patients taking anti-HIV drugs.   "
169722|NCT00050921|"     This study is designed to evaluate the ability of growth hormone (GH, also known as     somatropin) to increase CD4+ cell counts in patients taking anti-HIV drugs. The study is     targeted toward patients with low levels of HIV who continue to have low CD4+ cell counts.   "
169723|NCT00050934|"     This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on     therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.   "
169726|NCT00050973|"     This study evaluates the use of Targretin capsules (bexarotene) in combination with standard     chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients     who have not yet received chemotherapy for their lung cancer.   "
169727|NCT00050986|"     The goal of this clinical research study is to find the highest safe dose of the new drug     ZARNESTRA (R115777) and temozolomide that can be given to patients with brain tumors     (glioblastoma multiforme, GBM). The second goal is to learn if these drugs given in     combination can shrink or slow the growth of brain tumors. The safety of this treatment will     also be studied.   "
169728|NCT00050999|"     The purpose of this study is to compare the effectiveness of two dose levels of ONTAK     (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell     lymphoma.   "
169729|NCT00051012|"     The purpose of this study is to provide an opportunity for patients who exhibit progressive     disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also     designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients     whose tumors do not express CD25.   "
169730|NCT00058669|"     To examine potential differences in the prevalence and pattern of risk factors for coronary     heart disease in a sample of 500 self-identified lesbians and 500 heterosexual women, matched     for age, socioeconomic status, and ethnicity.   "
169731|NCT00058682|"     Fluconazole is an FDA-approved drug that is widely used to treat fungal infections due to     candida. The experimental drug anidulafungin has been found to be active in treating     life-threatening fungal infections. The purpose of this study is to determine whether     anidulafungin is as effective as fluconazole in treating candidemia, an invasive form of     candidiasis.      Three hundred patients 16 years of age or older will participate in this study. Participants     will be randomly assigned to one of two groups: one-half will receive anidulafungin; the     other half will receive fluconazole. They will receive the drug for as few as 10 days or for     up to 42 days, depending on the seriousness of the infection. The drug will be given over a     four-hour period on the first day, and over two hours on the remaining days. While taking the     study medication, participants will be required to give blood samples every week until the     end of treatment. At two weeks and six weeks following the end of therapy, participants will     return for evaluation.      Prior to their participation in this study, patients will undergo the following evaluations:     a physical exam, an eye exam, an electrocardiogram, and possibly blood work.   "
170759|NCT00073346|"     This study will develop and test a cognitive behavioral treatment for compulsive accumulation     of goods.   "
169732|NCT00058695|"     This study will examine whether certain polymorphisms (small gene variances) predispose     people to develop age-related macular degeneration (AMD). This eye condition affects people     over 50 years of age and can cause permanent loss of central vision. The study will examine     and compare the frequency of polymorphisms in patients with AMD to that of individuals     without AMD. This information will help identify genetic risk factors for the AMD and may     lead to the development of more effective treatments.      Patients 50 years of age and older with advanced AMD and healthy normal volunteers may be     eligible for this study. All participants will provide an eye health history and will have 10     milliliters (2 teaspoons) of blood drawn from an arm vein. The DNA in the blood will be     isolated and tested for certain genes that other research indicates are important in aging     and age-related diseases. The normal and polymorphic gene sequences will be identified and     compared in patients with AMD and control subjects to determine if any of the polymorphisms     are related to development of AMD.      In addition, control subjects will have a routine eye examination, including dilation of the     pupils for examination of the back of the eye.   "
169733|NCT00058721|"     This study will use single photon emission computed tomography, or SPECT (see below), to     examine brain nicotine receptors in evaluating the role of a chemical called acetylcholine in     memory and other problems in Parkinson's disease (PD). Acetylcholine acts by binding to these     nicotine receptors.      Healthy normal volunteers and patients with Parkinson's disease 40 years of age and older,     with or without dementia, may be eligible for this study. Candidates will be screened with     physical and neurological examinations, a pen and paper test of memory and other mental     functions, blood tests, and, for women of childbearing potential, a pregnancy test. Patients     with cognition problems will have more intensive mental function tests.      All participants will undergo the following procedures:        -  Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves          to show structural and chemical changes in the brain. During the scan, the subject lies          on a table in a narrow cylinder (the scanner). The time required in the scanner is about          1 hour, during which the subject is asked to lie very still for 10 to 15 minutes at a          time. He or she can speak with a staff member via an intercom system at all times during          the procedure.        -  SPECT: This nuclear medicine test produces a picture of the receptors in the brain. On          the night before the scan, the day of the scan, and for 4 days after the scan, subjects          take an oral dose of potassium iodide to protect the thyroid gland from the radioactive          tracer used in the SPECT procedure. (People allergic to potassium iodide will take          potassium perchlorate instead.) Before the scan, small radioactive markers containing          99Tc are glued to the subject's head. Two catheters (thin, flexible tubes) are placed in          veins in the arms to inject the radioactive tracer [123I]5-I-A-85380 and to draw blood          samples. Another catheter is placed in an artery in the wrist to draw arterial blood          samples. During the scan, the subject lies on a bed with his or her head held still with          a head holder. The scans are taken over a 6-hour period after injection of          [123I]5-I-A-85380. An electrocardiogram, respiration, and blood pressure measures are          taken before the tracer is injected, then 5 minutes after the injection, and again 30 to          60 minutes after the injection. Blood and urine samples are collected 5 to 6 hours after          starting the scan. Participants are asked to urinate at least every 2 hours for 12 hours          after injection of [123I]5-I-A-85380 to decrease radiation exposure.   "
169734|NCT00058734|"     The aim of this trial is to find out if immune responses to HIV can be boosted in individuals     who start medicines soon after being infected. If immune responses can be boosted to the     virus, this may allow the body to control HIV without the need for medications. This study is     designed to test a new strategy for boosting immune responses to HIV and to evaluate if these     responses allow people to have control of HIV without medicines.   "
169735|NCT00058747|"     This is a Phase II, exploratory, open-label study of the investigational product AG-858, in     patients who are cytogenetically positive after treatment with Gleevec.      The trial will consist of three independent Phase II evaluations of patient groups according     to their cytogenetic status as defined in the eligibility criteria (Eligibility Criteria 4a,     4b, and 4c).   "
169736|NCT00058760|"     This study will evaluate the effectiveness of a program designed to prevent early sexual     behavior in middle school-aged African American girls.   "
169764|NCT00060385|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known which combination chemotherapy regimen is more effective in treating     non-Hodgkin's lymphoma.      PURPOSE: Randomized phase II/III trial to compare the effectiveness of combination     chemotherapy with or without etoposide in treating older patients who have non-Hodgkin's     lymphoma that has not been previously treated.   "
169737|NCT00058773|"     Subjects have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma, which has     come back or not gone away after treatment, including the best treatment we know for relapsed     Lymphoma. We are asking subjects to volunteer to be in a research study using Epstein Barr     virus (EBV) specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has     never been used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it     has been used successfully in children with other types of blood cancer caused by EBV after     bone marrow transplantation.      Some patients with Hodgkin disease or non-Hodgkin Lymphoma show evidence of infection with     the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time     of their diagnosis of Lymphoma. EBV is often found in the cancer cells suggesting that it may     play a role in causing Lymphoma. The cancer cells infected by EBV are very clever because     they are able to hide from the body's immune system and escape destruction. We want to see if     we can grow special white blood cells, called T cells, that have been trained to kill EBV     infected cells and give them back to subjects.   "
169738|NCT00058786|"     This is a research study to determine the safety and dosage of special cells that may make     the patients own immune system fight the cancer. To do this, we will put a special gene into     cancer cells that have been taken from the patient. This will be done in the laboratory. This     gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may     help the immune system kill cancer cells. Additionally, we will stimulate the cancer cells     with another natural protein called CD40 ligand (CD40L), which preclinical human and animal     studies suggest will help IL-2 perform better. Some of these cells will then be put back into     the body. The cells are grown with normal embryonic fibroblasts. Studies of cancers in     animals and in cancer cells that are grown in laboratories suggest that combining substances     like IL-2 and CD40L helps the body kill cancer cells.      The purpose of this study is to learn the side effects and the safest effective dose of these     special cells on the disease   "
169756|NCT00060268|"     RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to     light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells     and, when exposed to light, become active and kill the tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy with HPPH in     treating patients who have obstructive esophageal tumors.   "
170760|NCT00073359|"     The purpose of this study is to identify and evaluate therapist behaviors that affect how     well and how long adolescent patients stay in treatment for depression.   "
169739|NCT00058799|"     This research study is to determine the safety and dosage of special cells that may make the     patients own immune system fight the leukemia. To do this we will put special genes into     cells called fibroblasts that we have grown in the laboratory from a skin sample. The genes     we put in these fibroblasts make them produce substances called CD40 Ligand (CD40L) and     interleukin-2 (IL-2). These are natural substances that may help the immune system kill     leukemia cells. Some of these fibroblasts producing CD40L and IL-2 mixed with a small     quantity of the leukemic cells will then be put back into the body.      Studies of cancers in animals and in cell lines suggest that substances like CD40L and IL-2     when mixed with cancer cells do help the body to recognize and kill these cancer cells. A     treatment using IL-2 has been previously used in more than 40 children with neuroblastoma and     similar treatments are being used in adults with other cancers. Some of the patients have     shown significant tumor responses. However, we do not know if this treatment will work and we     do not know the right amount of each of the special cells to use, so different patients will     get different combination and numbers of cells.      The purpose of this study is to learn the side effects and safe dosage of these special     cells.   "
169740|NCT00058812|"     Patients have a type of blood cell cancer or other blood problem that is very hard to cure     with standard treatments and s/he will receive a bone marrow transplant. If the patient does     not have a brother or sister whose marrow is a perfect match, this bone marrow will come     from a donor whose marrow is the best match available. This person may be a close relative or     an unrelated person whose bone marrow best matches the patient's, and who agrees to donate     marrow.      In normal people, the Epstein-Barr (EB) virus infection causes a flu like illness and usually     gets better when the immune system controls the infection. The virus, however, remains hidden     in the body for life. After a transplant, while the new immune system is growing back, the EB     virus can come out and infect cells and cause them to grow in an uncontrolled manner.     Patients can develop fevers, swollen lymph nodes and damage to other organs such as kidneys     and lungs. This infection acts like a cancer because the cells infected with EB virus grow     very quickly and there is no known effective treatment. This sort of infection will occur in     between 10-30% of patients receiving a transplant from a donor who is not a perfect match,     and has been fatal in nearly all these cases.      This infection occurs because the immune system cannot control the growth of the cells. We     want to see if we can prevent it from happening or treat it by giving the patient a kind of     white blood cell called T cells that we have grown from the marrow donor. These cells have     been trained to attack EB virus infected cells. We will grow these T cells from blood taken     from the donor at the time of bone marrow harvest. These T cells will be stimulated with the     donor's EB virus-infected cells which have been treated with radiation so they cannot grow.     After mixing these cells together we will be able to grow special T cells from the donor that     can attack EB virus infected cells. We will then collect the T cells and make sure they can     kill the virus infected cells. These EBV specific T cells are an investigational product not     approved by the Food and Drug Administration.   "
169741|NCT00058825|"     Patients are being asked to participate in this study because they have a cancer in their     blood, Fanconi's Anemia, or have been unsuccessfully treated for bone marrow failure such as     Aplastic Anemia or Paroxysmal Nocturnal Hemoglobinuria. Any of these conditions could benefit     from an allogeneic stem cell transplant using a donor that is related to the patient.      Stem cells are created in the bone marrow. They grow into different types of blood cells that     the patient needs, including red blood cells, white blood cells, and platelets. In a     transplant, the patient's own stem cells are killed and then replaced by stem cells from the     donor.      Usually, patients are given very strong doses of chemotherapy prior to receiving a stem cell     transplant. However, because of the patient's condition, they have a high risk of     experiencing life-threatening treatment-related side-effects. Recently, some doctors have     begun to use chemotherapy that does not cause as many side-effects before patients receive a     transplant.      This research study adds CAMPATH 1H to a low-dose chemotherapy regimen, followed by an     allogeneic stem cell transplantation. We want to see whether adding CAMPATH 1H to the     transplant medications helps in treating the disease. We also want to see whether there are     fewer life-threatening side-effects from the treatment. CAMPATH 1H is a drug that is still     being studied. CAMPATH 1H stays active in the body for a long time after patients receive it,     which means it may work longer at preventing graft-versus-host-disease (GvHD) symptoms.   "
169742|NCT00058838|"     The primary purpose of this study is to determine whether sumanirole, at three different dose     levels, is effective and safe in the treatment of the signs and symptoms of early Parkinson's     disease   "
169743|NCT00058851|"     The purpose of this study is to examine the short-term and long-term efficacy of massage     therapy alone compared to massage therapy plus compression bandaging in the treatment of     breast cancer treatment-related swelling of the arms and legs.   "
169788|NCT00060697|"     The goal of this study is to enhance the mother's role in promoting avoidance of sexual risks     and problem behaviors in 6- to 12-year-old children. Consenting mothers will attend a     10-session program designed to enhance the quality of mother-child communication, identify     sexual risks, and increase parental monitoring and self-efficacy.   "
169744|NCT00058864|"     HIP PRO is a multicenter randomized, controlled trial of an energy absorbing and distributing     padding system designed to reduce the incidence of hip fractures in 546 nursing home (NH)     residents. The trial is being conducted in three geographic regions of the US: Boston, St.     Louis, and Baltimore. Non bed- or chair-bound residents over the age of 65 are given     protective underwear containing a single pocket and hip pad so that each resident becomes     his/her own control. During the trial, hip fracture incidence will be compared in padded and     unpadded hips using an intent to treat analysis. A secondary aim is to identify resident and     facility factors contributing to non-adherence with the use of the hip protector.   "
169745|NCT00058890|"     In this study, the effect of the medication gabapentin to treat itching secondary to liver     disease is being studied.      There are some funds to cover travel expenses for patients who are not from New York.      Gabapentin is approved to treat seizures in human beings. In this study, patients with liver     disease who meet inclusion criteria are admitted to the research hospital of the New York     Presbyterian Hospital to record scratching behavior by the use of a machine designed for that     purpose. Blood work will be obtained. After completion of recording, patients are assigned by     chance to receive active medication or placebo (a capsule that does not contain active     medication). The patients will come to the outpatient office of the research hospital 2 weeks     into the study for an interview and blood work. After 4 weeks, patients are readmitted to the     hospital to record scratching behavior. After data are collected, the code is broken, if     patient had been on inactive drug, active drug will be supplied as per protocol for 4 weeks.     Blood work will be obtained. If patient had been randomized to active medication, the study     will provide one week supply of drug. After that, the referring physician, with whom the     study was previously discussed, could prescribe the medication as it is available.   "
169803|NCT00060905|"     The purpose of this study is to determine the safety and effectiveness of Depakote ER     compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.   "
169747|NCT00058929|"     This trial is a study of Remodulin in patients with pulmonary arterial hypertension who have     been transitioned from Flolan therapy. The study consists of Screening, Baseline and     Treatment Phases.      Patients meeting all inclusion/exclusion criteria during the Screening Phase will enter the     Baseline Phase, during which baseline exercise capacity, vital signs, and clinical signs and     symptoms of the disease will be assessed. After confirmation of all inclusion/exclusion     criteria, patients will be assigned to study drug (Remodulin or placebo) and will enter the     Treatment Phase. The Treatment Phase begins with a Dose Transition Period, during which     patients will begin receiving subcutaneous study drug at a low dose determined by the     patient's current dose of Flolan. The study drug dose will be increased gradually while the     Flolan dose is decreased gradually over a period of up to 14 days. The dose changes will     continue until Flolan therapy has been discontinued and the patient is stable on study drug.      Patients who are transitioned off Flolan, who are stable on study drug will be discharged     from the clinic, and will continue to receive study drug on an outpatient basis. The patient     will return to the clinic at Weeks 4 and 8 for assessments. Patients will remain on study     drug for 8 weeks from the first dose of study drug. At Week 8, final assessments will be     conducted and the patient will be dismissed from the study. Patients who successfully     complete Week 8 assessments may be offered Remodulin therapy or other therapy, at the     investigator's discretion.   "
169748|NCT00058942|"     This study is being conducted in Sonoma County, California.      Gastrointestinal illness and diarrhea are recognized as a significant cause of morbidity and     mortality in the elderly. One study showed that 51% of deaths caused by diarrhea over a     9-year period occurred in individuals over the age of 74 years. Although many infectious     diseases are more problematic in the elderly because of a decline in immune function and a     higher incidence of pre-existing malnutrition and dehydration, it is still not known what the     principal modes of transmission are and which infectious agents are responsible.      The principal objective of this study is to evaluate the ability of in-home treatment of     tapwater to reduce gastrointestinal illness in non-institutionalized elderly individuals. The     trial will test household-level treatment of drinking water by joint use of ultraviolet light     and filtration devices. A secondary objective is an estimate of the incidence of specific     bacterial, viral, and protozoan agents in stool specimens collected from elderly individuals     with gastrointestinal symptoms that might be related to water consumption.   "
169749|NCT00058955|"     The purpose of this study is to learn more about the effects of gamma-hydroxybutyric acid     (GHB) by comparing its physiological, behavioral and subjective effects with those of several     other drugs.   "
169750|NCT00058968|"     The purpose of the study is to determine if duloxetine can help patients with painful     diabetic neuropathy.   "
169751|NCT00058981|"     Randomized, double-blind, parallel-group study to evaluate safety and efficacy of multiple     subcutaneous doses of DiaPep277 in patients with Latent Autoimmune Diabetes in Adults (LADA).     Study medication will be administered at time 0, 1 and 3 months, and then every 3 months for     a total of 8 administrations. The total duration of the trial is 24 months (treatment for 18     months and follow-up for an additional 6 months). Patients will be male or female between the     ages of 30 and 65 years, inclusive, within 2 to 60 months of the diagnosis of diabetes     mellitus. Subjects must be positive for glutamic acid decarboxylate (GAD) autoantibodies. At     the Screen Visit (Visit 2), all subjects will be asked to discontinue their use of all oral     antidiabetic medications with the exception of metformin. The subjects will be placed on a     stable regimen of insulin and diet (plus metformin if needed). Prior to the Baseline Visit     (Visit 3), diabetic control must be achieved by diet and insulin (plus metformin if needed).   "
169752|NCT00058994|"     The purpose of this study is to demonstrate that anecortave acetate is superior to placebo in     maintenance of visual acuity at the 12- and 24-month visits.   "
169789|NCT00060710|"     The purpose of this study is to determine the efficacy of CP-461 given twice daily orally in     patients with advanced or metastatic malignant melanoma and to evaluate the safety profile of     CP-461 in this patient population.   "
169753|NCT00059020|"     This study will examine tissue from gliomas (a type of brain tumor) removed during surgery     for gene mutations, or changes, thought to be involved in tumor formation and growth. One     common gene mutation causes the receptor for a protein called epidermal growth factor (EGF)     to be in an active state all of the time, allowing uncontrolled cell growth that can lead to     tumor formation. This study will analyze blood and tumor tissue samples from patients with     gliomas for:        -  Changes in the EGF gene in the tumor        -  Changes in other genes, such as that for the EGF receptor (EGFR)        -  Changes in levels of EGF and EGFR, and in other proteins and genes that respond to          changes in the levels of these proteins in the tumor        -  Changes in the EGF gene and protein in the blood      The study will also determine if production of EGF and EGFR obtained from glioma and from     blood cells derived from the tumor can be altered in the laboratory to grow indefinitely in     culture.      Patients between 18 and 75 years of age with a brain tumor that requires surgical treatment     may be eligible for this study.      Participants will be admitted to the NIH Clinical Center for about 3 to 10 days. They will     have a physical and neurological examination, blood and urine tests, other tests, if     medically necessary, and will be evaluated and prepared for surgery. During surgery, as much     of the tumor as possible will be removed. A small amount of the tumor tissue will be     collected for this study. No tissue will be removed for this study that would not otherwise     have been removed. Some of the tissue will be used to culture glioma cells and the rest will     be frozen and stored for examination, as described above. If any normal-appearing brain     tissue is removed during surgery in order to enhance safety in removing the tumor, the normal     tissue will be studied as well. Brain tissue that appears normal will not be removed strictly     for research.      During surgery and the day after surgery, a blood sample will be drawn from a catheter     (plastic tube) that was placed in an artery or vein for surgery. If catheters are no longer     in place, blood will be drawn through a needle in a vein.   "
169755|NCT00059046|"     Serotonin is a chemical involved in the regulation of emotions, anxiety, sleep, stress, and     other body functions. The purpose of this study is to use brain imaging technology to study     how serotonin works in the brain.      The serotonin transporter (SERT) regulates the release of sertonin throughout the body. Until     recently, radioactive chemicals called tracers were not suitable for viewing SERT activity.     However, a newly developed tracer called [11C]DASB can be used with positron emission     tomography (PET) imaging to view the parts of the brain that use serotonin.      Participants in this study will be screened with medical and psychiatric examinations, an     electrocardiogram (EKG), and blood and urine tests. This study comprises two parts. During     Part 1, participants will undergo a whole-body PET scan. During Part 2, participants will     undergo a magnetic resonance imaging (MRI) scan of the brain. At the next study visit,     participants will have one or two PET head scans. If not is not possible to perform both     scans on the same day, an additional visit will be scheduled for the second PET scan.   "
169804|NCT00060918|"     To evaluate the effects of two different antihypertensive medications in the drug class of     beta-blockers on control of glucose in Type II diabetic patients with high blood pressure.   "
169757|NCT00060294|"     RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can     locate cancer cells and either kill them or deliver radioactive cancer-killing substances to     them without harming normal cells.      PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 ibritumomab tiuxetan in     treating patients who have Waldenstrom's macroglobulinemia.   "
169758|NCT00060307|"     This phase II trial is studying how well erlotinib works in treating patients with locally     advanced or metastatic papillary renal cell (kidney) cancer. Erlotinib may stop the growth of     tumor cells by blocking the enzymes necessary for tumor cell growth   "
169759|NCT00060320|"     RATIONALE: The herbal supplement black cohosh may be effective in relieving hot flashes in     women.      PURPOSE: Randomized phase III trial to determine the effectiveness of black cohosh in     relieving hot flashes in women who have breast cancer or who are at risk of developing breast     cancer.   "
169760|NCT00060333|"     This phase II trial is studying how well adjuvant radiation therapy works in treating     patients who have undergone surgery for desmoplastic melanoma. Radiation therapy uses     high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery may kill any     tumor cells remaining after surgery.   "
169761|NCT00060346|"     RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy work in different ways to stop cancer cells from dividing so they stop growing     or die. Combining rituximab with combination chemotherapy may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with combination     chemotherapy works in treating patients with newly diagnosed Waldenstrom's macroglobulinemia.   "
169762|NCT00060359|"     This phase I trial is studying the side effects and best dose of polyglutamate paclitaxel     when given together with carboplatin in treating patients with ovarian epithelial,     peritoneal, or fallopian tube cancer. Drugs used in chemotherapy such as polyglutamate     paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop     growing or die. Polyglutamate paclitaxel may be able to deliver the drug directly to tumor     cells while leaving normal cells undamaged. Combining polyglutamate paclitaxel with     carboplatin may kill more tumor cells.   "
169763|NCT00060372|"     This phase I trial is studying how well ipilimumab works after allogeneic stem cell     transplant in treating patients with persistent or progressive cancer. Monoclonal antibodies     can locate cancer cells and either kill them or deliver cancer-killing substances to them     without harming normal cells.   "
169765|NCT00060398|"     RATIONALE: Epoetin alfa may stimulate red blood cell production and may help improve     cancer-related anemia and fatigue. Steroid therapy with dexamethasone may increase the     effectiveness of epoetin alfa. It is not yet known if epoetin alfa is more effective with or     without dexamethasone in treating anemia-related fatigue in patients with prostate cancer.      PURPOSE: This randomized phase III trial is studying epoetin alfa and dexamethasone to see     how well they work compared to epoetin alfa alone in treating anemia-related fatigue in     patients with prostate cancer that is refractory to treatment with hormone therapy.   "
169766|NCT00060411|"     Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their     growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of     colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy work in     different ways to stop tumor cells from dividing so they stop growing or die. Combining     erlotinib and bevacizumab with combination chemotherapy may kill more tumor cells. This phase     I trial is studying the side effects and best dose of erlotinib when given together with     bevacizumab, fluorouracil, leucovorin, and oxaliplatin in treating patients with metastatic     or locally advanced colorectal cancer.   "
169767|NCT00060424|"     This clinical trial studies how well giving fludarabine phosphate together with total-body     irradiation (TBI) before donor peripheral blood stem cell transplant works in treating     patients with chronic lymphocytic leukemia or small lymphocytic leukemia. Giving low doses of     chemotherapy, such as fludarabine phosphate, and TBI before a donor peripheral blood stem     cell transplant helps stop the growth of cancer cells. Giving chemotherapy before or after     peripheral blood stem cell transplant also stops the patient's immune system from rejecting     the donor's stem cells. The donated stem cells may replace the patient's immune cells and     help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving cyclosporine and mycophenolate mofetil before and after the transplant may stop     this from happening.   "
169768|NCT00060437|"     RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who     have prostate cancer that no longer responds to androgen ablation therapy.   "
169769|NCT00060450|"     The purpose of this study is to evaluate the effects of inhaled nitric oxide on both     short-term physiology as well as on the development of ischemia-reperfusion lung injury     (IRLI) in the immediate post transplant period. The specific hypothesis is that inhaled NO     post lung transplantation will improve gas exchange/hemodynamic and thus reduce the     development of post transplant IRLI.   "
169770|NCT00060463|"     This study will evaluate the effect of easy access to emergency contraceptive pills (ECPs) on     the rates of pregnancy and sexually transmitted infections (STIs).   "
169771|NCT00060476|"     To determine the efficacy and safety of an investigational compound (MK0966) for the     prevention of prostate cancer.   "
169772|NCT00060489|"     The purpose of this study is to evaluate the efficacy and safety of quetiapine in the     treatment of a major depressive episode in patients with bipolar disorder.   "
169773|NCT00060502|"     The purpose of this study is to evaluate the effectiveness and safety of infliximab, the     active ingredient in Remicade, for the treatment of cachexia in pancreatic cancer patients     who are receiving chemotherapy with gemcitabine.   "
169774|NCT00060515|"     The objective of the study is to determine the safety and tolerability of RG2133 in patients     with Mitochondrial Disease.   "
170761|NCT00073372|"     The purpose of this study is to determine the effectiveness of abciximab in the treatment of     acute ischemic stroke.   "
169775|NCT00060528|"     Background:       Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and     follows lung cancer as the leading cause of cancer death.       Vaccine strategies represent a novel therapeutic approach in the treatment for prostate     cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen     (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial     cells.      Objectives:       The primary objective is to determine the impact of granulocyte-macrophage colony     stimulating factor (GM-CSF) and recombinant fowlpox granulocyte-macrophage colony stimulating     factor (rF-GM-CSF) on the immunologic response in patients treated with these vaccines.       Secondary - to determine the change in prostatic specific antigen (PSA)-specific T cells in     patients treated with these vaccines using enzyme linked immunosorbent spot (ELISPOT) assay     analysis.       To document any objective anti-tumor responses that may occur.      Eligibility:       Patients must have androgen insensitive metastatic prostate cancer.       All patients will have received and progressed on hormonal therapy.       Must have objective evidence of metastasis or relapsing local disease. Therefore, must have     a rising PSA and at least one of the following: positive bone scan, palpable disease, or     positive imaging studies.       Must have a life expectancy of more than 6 months and Eastern Cooperative Oncology Group     (ECOG) status of 0 to 2.      Patients must be human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+).       Granulocyte count greater than or equal to 1,500/mm^3, Platelet greater than or equal to     100,000/mm^3, hemoglobin (Hgb) greater than or equal to 10Gm/dL, Lymphocyte count greater     than or equal to 500/mm^3 ;Bilirubin less than 1.5mg/dL, aspartate aminotransferase (AST) and     alanine aminotransferase (ALT) less than 2.5x upper limit of normal (ULN),Creatinine     Clearance greater than or equal to 60       No significant cardiac disease, no significant pulmonary disease, no serious inter-current     medical illness.      Design:       Cohorts three, four and five will provide safety data combining cohort two with rGM-CSF as     well as two doses of rFGM-CSF respectively.      This study will be conducted as a small, randomized pilot study to compare the immunologic     effects of the above vaccine strategy alone, with recombinant granulocyte-macrophage colony     stimulating factor (GM-CSF), or with either of 2 doses of fowlpox-GM-CSF.      This study will consist of 4 randomized arms of 8 patients each, all of whom are HLA-A2+.      The maximum accrual to the trial should be 62.   "
169785|NCT00060658|"     This study will use magnetic resonance imaging (MRI) to identify brain regions involved in     solving algebraic math problems. It will examine brain activation according to the level of     difficulty and the number of steps required to solve the problem. This information will help     identify a possible correlation between problem-solving strategies and patterns of brain     activation.      Undergraduate or graduate students between 19 and 36 years of age who have completed at least     2 years of college, have had at least one college course in integral calculus, and who have     no history of neurological disease may be eligible for this study. Candidates will be     screened with a medical history, including psychiatric and neurological information.      Participants will be asked to mentally solve a variety of integral calculus problems while     undergoing MRI scanning, a procedure that uses a strong magnetic field and radio waves to     produce images of structural and chemical changes in the brain. During the scan, the subject     lies on a table in a narrow cylinder (the scanner) containing a magnetic field. A problem and     possible solution are presented to the subject, who presses a button to verify if the answer     is correct. At the end of the test, the participant completes a follow-up questionnaire to     determine the problem-solving strategies used.   "
169776|NCT00060541|"     This study offers evaluation and treatment of patients with a variety of neurological     disorders that may require surgery. The protocol is not designed to test new treatments;     rather, patients will receive standard care. The study is designed to: 1) allow NINDS s     Surgical Neurology Branch staff to learn more about changes that cause nervous system     disorders, 2) train physicians in the evaluation and treatment of these disorders; and 3)     establish a pool of patients who may be eligible for other NINDS protocols. (Participants in     this protocol will not be required to join another study; the decision will be voluntary.)      Patients of all ages with a disorder of the central nervous system (brain and spinal cord) or     pituitary gland that may require surgery for diagnosis or treatment may be eligible for this     study. In some cases surgery will not be needed. Candidates will be screened with a medical     history and physical examination.      Participants may undergo tests, medial treatment, or surgical treatment to help diagnose or     treat their condition. In most cases, care provided at the NIH will be limited to evaluation     and surgery. Procedures may include laboratory tests, imaging tests, such as magnetic     resonance imaging (MRI), computed tomography (CT) scans, angiograms, and other procedures to     confirm the patient s diagnosis or help guide treatment. Patients who require surgery will be     offered standard surgical care at NIH. Those whose procedure includes removal of tissues or     fluids for diagnostic studies will be asked to allow a portion of the tissue to be used for     research purposes, including analysis for gene and protein abnormalities that may be involved     in causing the disorder or in influencing the patient s response to treatment. Blood samples     will also be drawn for research.   "
169777|NCT00060554|"     The purpose of this research study is to obtain experience in the use of fondaparinux     (Arixtra) as compared to heparin when administered to patients who undergo percutaneous     coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a     coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and     heparin are drugs that inhibit blood clotting.   "
169778|NCT00060567|"     E7070 and irinotecan will be administered to patients with GI tract, pancreatic or lung     tumors on Days 1 and 8 of a 21-day cycle, or Days 1 and 15 of a 28-day cycle according to one     of two E7070 dose escalation schemes.   "
169779|NCT00060580|"     This study will evaluate the ease and reliability of Raman scattering spectroscopy, a new     technique to measure the amount of the pigment lutein in the retina, the light-sensitive     tissue lining the back of the eye. The highest concentrations of lutein are in the center of     the retina, called the macula, which is the area most important for fine, detailed vision.     The functions of lutein are not fully known. Besides absorbing blue light, it may help     protect against abnormal changes in the retina, such as age-related macular degeneration.     Until recently, lutein was measured using long, cumbersome, and difficult tests. This study     will evaluate a new instrument that provides faster measurements. It will be tested under     different conditions, such as wearing or not wearing glasses or contact lenses, or dilating     or not dilating the pupil of the eye.      Healthy normal volunteers between 20 and 65 years of age may be eligible for this study,     which involves two visits to the NIH Clinical Center, as follows:      Visit 1 - Screening        -  Medical history and physical examination, including measurement of vital signs (blood          pressure, pulse, temperature, and breathing rate), and examination of the head and neck,          heart and lungs, and arms and legs.        -  Eye examination, including eye chart test, eye pressure measurement, examination of          pupils and eye movements, and examination of the retina (back part of the eye) using a          strong light and magnifying lens after dilation of the pupils.        -  Raman scattering spectroscopy to measure lutein. For this test, the subject looks with          one eye at a brief, bright flash of bluish light (similar to a flashbulb light) from a          laser. This is repeated several times. Subjects who wear glasses or contact lenses for          distance vision will be tested without them and then again with a lens in front of the          eye. Subjects who do not wear glasses or contact lenses will be tested before and after          dilation of the pupil.        -  Contrast sensitivity to assess ability to identify an object from the background and to          see everyday objects. The subject looks at and identifies a variety of objects of          different shapes and sizes.        -  Color vision to determine the ability to identify different shades of color. The subject          arranges a line of colorful discs, similar to checkers, in order of similar shades.      Visit 2 - Repeat Spectroscopy      Subjects return 1 week after the screening visit for a repeat Raman scattering spectroscopy     to evaluate the precision of the measurements.   "
169805|NCT00060931|"     Evaluation of the effect of two different antihypertensive treatments on control of glucose     in Type II diabetic patients with high blood pressure   "
180399|NCT00186277|"     To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in     bladder cancer.   "
169780|NCT00060593|"     This study will use functional magnetic resonance imaging (MRI) to examine loss of balance in     the elderly. Falls due to balance problems are a major health issue in older people, often     resulting in bone fractures and other bodily injuries, and in functional decline. Risk     factors for falling in the elderly include some standing positions in which older people     usually experience balance problems, such as leaning forwards or backwards. Functional MRI     records brain function while the subject performs a task, such as moving a limb or speaking,     and detects changes in the brain regions involved in those tasks. This study will look at     different brain areas to see which areas might control what people see around them while they     are standing.      Healthy normal volunteers between 20 and 90 years of age may be eligible for this study.     Candidates must be in good health, have no difficulties in performing activities of daily     living, and be able to walk for at least 400 meters (1/4 mile). They will be screened with a     medical history and physical examination.      Participants will undergo functional MRI while performing visual recognition tasks in two     experiments, described below. For the MRI procedure, the subject lies in the MRI scanner, a     narrow metal cylinder containing a strong magnet, for 20 minutes to 3 hours, with most scans     lasting between 45 and 90 minutes. The experiments are as follows:      Experiment 1      During MRI scanning, the subject watches computer-generated movies of a person leaning     forwards and backwards. When the subject recognizes an unstable body position in the     movements, he or she presses a computer mouse.      Experiment 2      During MRI scanning, the subject watches still pictures of people leaning in stable and     unstable postures and presses a button as soon as he or she recognizes that the posture is     unstable.   "
169781|NCT00060606|"     Spina bifida (myelomeningocele) is a complex birth defect in which a portion of the spinal     cord is not fully developed. The overlying bones and skin are incompletely formed and the     underdeveloped area of the spinal cord is exposed on the surface of the back. Spina bifida     defects are closed soon after birth to prevent further damage to the spinal cord and nerves.     The Management of Myelomeningocele Study (MOMS) is a research study comparing two approaches     to the treatment of babies with spina bifida: surgery before birth (prenatal surgery) and the     standard closure, surgery after birth (postnatal surgery).   "
169782|NCT00060619|"     This study will evaluate a new model for assessing and treating migraine and recurrent     abdominal pain in children. The model combines behavioral techniques such as relaxation     training with biologic components such as thermal biofeedback.   "
169783|NCT00060632|"     Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of     ridaforolimus in patients with refractory or recurrent malignancies, including myeloma and     lymphoma.   "
169784|NCT00060645|"     Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of     AP23573 in patients with refractory or recurrent malignancies, including myeloma and     lymphoma.   "
169786|NCT00060671|"     The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name     pending) with the monoclonal antibody rituximab, leads to an increase in the period of     patients' remission, compared to rituximab alone.   "
169787|NCT00060684|"     The aim of this trial is to determine the appropriate dose of pixantrone to be used in this     combination and obtain data on the combination's safety and activity profile.   "
173728|NCT00107952|"     Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug,     telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.   "
169790|NCT00060723|"     Sleep-disordered breathing (SDB) in children may be responsible for disruptive daytime     behaviors such as inattention and hyperactivity. Many children undergo tonsillectomy for SDB     and disruptive daytime behaviors. However, the link between SDB and disruptive behavior is     not clearly understood. This study will evaluate the relationship between SDB and disruptive     behavior.   "
169791|NCT00060736|"     This study evaluates the effects on mood when stopping estrogen replacement therapy.      The purpose of this study is to investigate the effects of estrogen levels on perimenopausal     depression. This study will examine short-term withdrawal of estrogen in women whose mood had     improved with estrogen therapy.      Perimenopause-related mood disorders cause significant distress in a large number of women.     Evidence suggests that estradiol may have beneficial effects in women with perimenopausal     depression. However, the effect of declining estradiol secretion during perimenopause has not     been fully examined.      Peri- and post-menopausal women who experience a remission of perimenopause-related     depression symptoms while on estrogen therapy and a control group of healthy volunteers on     hormone replacement therapy (HRT) will be switched from their current form of HRT to     estradiol for a 3-week period; volunteers will also complete symptom ratings to confirm the     absence of mood symptoms. Participants will then be randomly assigned to either continue     estradiol or take a placebo (an inactive pill) for an additional 3 weeks. Mood ratings will     be used to determine response to estradiol withdrawal.   "
169792|NCT00060749|"     This study will evaluate whether docosahexaenoic acid (DHA) dietary supplementation can     improve macular function in patients with Stargardt macular dystrophy and Stargardt-like     macular dystrophy. Stargardt macular dystrophy is a recessive inherited trait that causes a     severe form of macular degeneration. (The macula is the center part of the retina in the back     of the eye that is responsible for fine vision.) The disorder begins in late childhood and     progresses to a significant decrease in central vision. One of the earliest signs of the     disorder is accumulation in and under the macula of a fatty pigment called lipofuscin.     Stargardt-like macular dystrophy is a dominant inherited trait involving loss of central     vision, but it begins later than Stargardt macular dystrophy, and the accumulation of     lipofuscin extends beyond the central region of the macula. DHA is a fatty acid that is     essential for normal brain and eye development. It is normally found in the diet, but not in     large amounts. Supplements may help prevent or slow the progression of some eye diseases.      Patients with autosomal dominant Stargardt-like macular dystrophy or autosomal recessive     Stargardt macular dystrophy are eligible for this study. Candidates will be screened with the     following tests and procedures:        -  Medical history and physical examination.        -  Blood test to measure levels of DHA and vitamins.        -  Eye examination: The patient's vision and eye pressure are tested, then the pupils are          dilated to examine structures inside the eye. Photographs are also taken.        -  Visual field test: The patient looks at a tiny spot of light projected onto a white          screen and is asked to note when other lights appear at other places on the screen.        -  Electroretinogram (ERG): An electrode (small silver disk) is taped to the patient's          forehead. Drops are given to numb the eyes and special contact lenses are inserted in          the eyes. For the first part of the test, the patient looks at the center of a black and          white checkerboard screen that flickers for 30 seconds at a time. This is repeated 16 or          more times. For the second part of the test, the patient looks inside a sphere, in which          flashes of light flicker for 20 seconds at a time. This is repeated four or more times.          The contact lenses sense small electrical signals generated by the retina during the          tests.      Participants will begin taking DHA capsules or a placebo (look-alike capsules with no active     ingredient) from 1 week to 3 months after enrolling in the study and will repeat several of     the screening tests at follow-up visits scheduled 3, 6, 9, 12, and 15 months after they start     taking the capsules. They will also be interviewed about any treatment side effects.   "
169793|NCT00060762|"     This study will evaluate the long-term effectiveness of interpersonal psychotherapy,     behavioral weight loss interventions, and guided self help treatments in treating binge     eating disorder (BED).   "
169806|NCT00060944|"     The purpose of this study is to test the safety and effectiveness of an investigational     chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or     leiomyosarcoma.   "
169807|NCT00060957|"     This study examines botulinum toxin (BOTOX, or BTX) for the treatment of muscle twitches and     spasticity associated with cerebral palsy in children. Botulinum toxin is a naturally     occurring bacterial toxin (botulinum toxin) that inactivates certain parts of muscles.   "
169794|NCT00060775|"     The purpose of this study is to use brain imaging technology to examine brain changes that     occur in children when they are exposed to various kinds of emotional tasks and to determine     if these changes are related to the child's temperament.      Studies suggest that the risk for developing mood and anxiety disorders in preschool children     may be linked to differences in temperament. The relationship between temperament and risk or     resilience may reflect the influences of brain activity on behavior at different stages of     childhood development. Behavioral inhibition and mood or anxiety disorders have been linked     to disturbances in the circuitry of several areas in the brain. However, the involvement of     this circuitry in temperament remains unclear. This study will use functional magnetic     resonance imaging (fMRI) to examine the function of different parts of the brain in children     who have previously undergone temperament studies and have had their temperaments classified.      Two sets of studies will be performed in the current protocol. A small set of pilot studies     will be performed in infants, by staff at the University of Maryland. In terms of the studies     among infants, these subjects will initially be contacted by staff at Maryland and then will     be seen at the NIH for up to three visits lasting between 4- to 5- hours during the first     year of life. These subjects also will undergo visits at the University of Maryland     throughout the first year of life.      This study will comprise up to four clinic visits. At Visit 1, children and their parents     will meet with study staff individually and together for psychiatric interviews. Children     will undergo a physical examination, medical history, a urine drug test, and practice in an     fMRI simulator. Saliva samples will be collected from the children and tests will be given to     assess stage of puberty, temperament, intelligence, feelings, experiences, and behavior.     Other visits include fMRI scans of the brain and other tasks.   "
169795|NCT00060788|"     Antisocial behavior often occurs in different generations within the same family. However, it     is not known what factors contribute to this passing of antisocial behavior from parent to     child to grandchild. This study is part of a project evaluating antisocial behavior in     families; it focuses on the passage of such behavior from one generation to the next.   "
169796|NCT00060801|"     The purpose of this study is to determine the effect of 24 weeks of treatment with BIIL 284     BS compared with placebo on pulmonary function and incidence of pulmonary exacerbation in     adult and pediatric cystic fibrosis patients.   "
169797|NCT00060814|"     The purpose of this pilot study is to examine the effects of combined pharmacotherapy     (Zyban/NRT)/behavioral treatment on smoking cessation among methadone maintenance therapy     patients.   "
169798|NCT00060827|"     Head impacts in sports can lead to brain injury even when the participant is wearing a     helmet. The forces that contribute to brain injury from sports-related head impacts are not     well understood. This study will test a new device to measure the speed of head impacts among     football players.   "
169799|NCT00060840|"     The purpose of this study is to assess the utility of nitric oxide for inhalation during left     ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is     to be assessed by the number of patients in each treatment group meeting failure criteria     within 24 hours on study drug, as defined by two or more of the following:        -  Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2        -  Administration of ≥ 20 inotropic equivalents (IE)             -  10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE             -  0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE             -  1 µg/kg/min milrinone is equivalent to 15 IE             -  0.1 U/min vasopressin is equivalent to 10 IE        -  Mean arterial pressure (MAP) ≤ 55 mmHg        -  Central venous pressure (CVP) ≥ 16 mmHg        -  Percent mixed venous oxygen saturation (SvO2) ≤ 55%      Or at least one of the following criteria:        -  Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure.          Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues          will not be considere 'failure to wean'        -  Death   "
169800|NCT00060853|"     This study will use magnetic resonance imaging (MRI) to identify brain regions involved in     social and emotional reasoning. It will identify differences in brain activity during task     performance between people who have a nervous system illness and those who do not. MRI is a     diagnostic tool that uses a strong magnetic field and radio waves to produce images of     structural and chemical changes in the brain.      Healthy normal volunteers between 21 and 55 years of age who are right-handed and are native     English speakers may be eligible for this study. Candidates will be screened with a medical     history, including psychiatric and neurological information.      Participants will be asked to perform social and emotional reasoning tasks, such as sorting     and judging rules and rule violations, while undergoing MRI scanning. Some tasks may simply     involve viewing items on a screen. Others may involve solving complex problems and responding     by pressing buttons. During the scan, the subject lies on a table in a narrow cylinder (the     scanner) containing a magnetic field. The scan will last about 2 hours, with subjects asked     to lie still for up to 10 minutes at a time.   "
169801|NCT00060866|"     This study will examine the effectiveness of the drug propranolol in preventing fainting in     patients with sympathoadrenal imbalance (SAI). SAI is a particular pattern of nervous system     and chemical responses in which the blood vessels in skeletal muscles do not remain     constricted appropriately during standing for a long time. This can lower blood pressure and     cause fainting. Propranolol Inderal (registered trademark) is a Food and Drug     Administration-approved drug that belongs to a class of drugs called beta-blockers. These     drugs slow the heart rate and maintain blood pressure in certain situations.      Patients 18 years of age and older with SAI may be eligible for this study. Screening     includes a tilt table test, described below, to determine if the patient has a particular     chemical pattern in the blood.      Patients enrolled in the study take propranolol pills in increasing doses during the first     week of the study to determine the proper dose for the individual. Then, the drug is stopped     until the experimental phase of the study begins. In this phase, patients are randomly     assigned to take either propranolol or placebo (look-alike pill with no active ingredient)     for 4 days. On the fourth day, the patient undergoes a tilt table test to determine whether     the treatment affects the patient's ability to tolerate tilt. For this test, the patient lies     on a padded table with a motorized tilt mechanism that can move the patient from a flat     position to an upright position in about 10 seconds. The patient remains upright for up to 45     minutes while the following measurements are taken:        -  Arterial blood pressure monitoring and arterial blood sampling. A catheter (thin,          plastic tube) is inserted into an artery in the elbow crease area of the arm or the          wrist. This catheter allows continuous blood pressure monitoring and sampling of          arterial (oxygenated) blood during the tilt test.        -  Venous blood sampling and measurement of epinephrine and norepinephrine release. A          catheter is inserted into a vein in each arm, one to collect venous (deoxygenated) blood          samples, and the other to inject radioactive epinephrine (adrenaline) and norepinephrine          (noradrenaline). These radioactive drugs, or ,tracers, allow measurement of the rate of          release of the body's own norepinephrine and epinephrine into the bloodstream.        -  Physiologic measurements. Blood pressure, heart rate, and EKG are measured continuously          during the tilt test session, and blood flows and skin electrical conduction are          measured intermittently. Blood flow is measured using sensors applied to the skin and a          blood pressure cuff around the limb. For skin blood flow measurements, a laser beam          scans the skin surface. The skin electrical conduction test measures how well the skin          conducts electricity. This is measured through sensors placed on the fingers or other          sites.      The effects of the test drug are allowed to wear off for 1 week, after which the entire tilt     test procedure is repeated. Patients who were given propranolol for the first test session     take placebo for the repeat session, and those who were given placebo take propranolol.   "
169802|NCT00060892|"     The primary purpose of this study was to assess the overall safety of different dose regimens     of AMG0001 (HGF transferred via plasmid vector) as well as evaluate the improvement of blood     perfusion in subjects with critical limb ischemia (CLI). This study also evaluated the     improvement in wound healing without adverse effects on the quality of life, as well as the     potential reduction of amputation, mortality and rest pain in the CLI population.   "
169817|NCT00061087|"     The purpose of this study is to treat Adult Attention Deficit Hyperactivity Disorder (ADHD)     in methadone patients.   "
169808|NCT00060970|"     Patients who are forced to rest or reduce activity as a result of illness, injury, or surgery     often experience resulting muscle weakness. This study will evaluate muscle features and     muscle strength in patients who are recovering from surgery for broken ankles. The goal of     this study is to improve the recovery of muscle function and overall ability after prolonged     periods of ankle inactivity due to surgery.   "
169809|NCT00060983|"     This study is part of a larger clinical trial that examines the potential of a 12-week     treadmill-training program to improve walking in patients with spinal cord injuries (SCIs).     Patients in the trial are at least 1 year past their injury. This substudy tests a     combination of two strategies to enhance the treadmill training program: electrically     stimulating a muscle withdrawal reflex and providing body weight support by partially     suspending patients as they walk on the treadmill.   "
169810|NCT00060996|"     The purpose of this study is to assess and compare the safety of continuous and daily     subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned     vascular interventional procedures; and to determine the effect of Remodulin on wound healing     and treadmill walk distance.   "
169833|NCT00061308|"     This research study was designed to determine the effectiveness of the drug, topotecan, given     intravenously (into a vein) together with the drug gemcitabine in patients with recurrent     platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of     mixed mullerian origin. Additional purposes are to determine the long term outcome and side     effects of this combination treatment.      Since topotecan and gemcitabine have different mechanisms of action, the combination of these     2 drugs may provide better results than either drug alone. Prior studies suggest that the     combination of topotecan and gemcitabine improves the effects on the tumor and also appeared     to be well tolerated.   "
169834|NCT00061321|"     Infants who are breast-fed by HIV infected mothers have an increased risk of becoming     infected with HIV. Standard therapy for the prevention of HIV infections in infants included     zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women     during labor, and a single dose of NVP for newborns given 72 hours after birth. This study     will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in     addition to standard therapy, will be more effective than standard therapy alone at     preventing HIV infections in these infants.   "
169811|NCT00061009|"     This study will investigate the relationship between susceptibility to hypnosis and     regulation of the autonomic nervous system (nerves that control involuntary body functions,     such as heart rate and sweating).      Hypnosis is a state of mind in which the individual is highly focused, relatively unaware of     his or her surroundings, and possibly more able to accept and use therapeutic suggestions.     People vary in their responsiveness, or susceptibility, while in hypnosis. People with     certain conditions, such as chronic fatigue syndrome (CFS), chronic pain, posttraumatic     stress disorder (PTSD), and generalized anxiety disorder (GAD) have altered hypnotic     susceptibility. Patients with chronic orthostatic intolerance (COI) often have symptoms     similar to those of individuals with CFS, chronic pain, PTSD, and GAD, and this study will     examine how patients with COI respond to hypnosis as compared with healthy normal volunteers.     COI is a group of disorders characterized by intolerance to prolonged standing. Among them     are neurocardiogenic syncope (NCS), in which patients have recurrent episodes of sudden loss     of consciousness, and postural tachycardia syndrome (POTS), in which patients have a     sustained increase in heart rate after standing.      In addition to the comparison of COI and normal volunteer responses to hypnosis, the study     will examine how hypnotic susceptibility is related to the ability to control autonomic     functions such as blood pressure, heart rate, and sweating. The autonomic nervous system is     activated when the body is stressed, not only from physical stimuli such as cold temperature,     but also from mental stimuli, such as seeing a rattlesnake up close. Hypnosis may, therefore,     be a useful tool to understand how the mind controls the autonomic nervous system.      Healthy normal volunteers and patients with NCS or POTS who are 18 years of age or older may     be eligible for this two-part study. In part 1, participants complete a questionnaire and are     then tested for hypnotic susceptibility. For this test, a professionally trained physician     guides the subject through a procedure to achieve a hypnotic state. The subject is asked to     perform several simple tasks and is then guided back to a normal state of being. In part 2,     the subject undergoes hypnosis again, during which the physician offers various suggestions     while monitoring activity of the subject's autonomic nervous system. The subject is connected     to various sensors that continuously monitor blood pressure, heart rate, blood flow, sweat     response, skin electrical conduction, and brain wave activity. An intravenous catheter is     inserted into an arm vein to collect blood samples. At the end, the subject is guided back to     a normal state of being.      The hypnosis session in part 1 is videotaped in order to: 1) permit review by a scientist who     is unaware of the subject's condition and whose judgment will not, therefore, be biased; and     2) have a record of the experimental data. Only qualified investigators will view the     videotape.   "
169812|NCT00061022|"     This study will determine if NXY-059 will improve recovery from an acute stroke. The study is     designed to look at both overall recovery and recovery of motor function, for example muscle     strengthen and coordination.   "
169813|NCT00061035|"     Dr. Frederick Millard, MD, Associate Clinical Professor at the UCSD Cancer Center, will be     conducting a 12-week study in advanced prostate cancer patients. The study will be held at     the UCSD Medical Center and will test an experimental investigational gene therapy vaccine     designed to make the patient's immune system react against telomerase, an enzyme expressed in     prostate cancer cells.   "
169814|NCT00061048|"     This study will examine the safety and effectiveness of Alemtuzumab (Campath-1H) for treating     patients with adult T-cell leukemia/lymphoma (ATL). ATL is caused by a virus called human     T-cell lymphotrophic virus type-1 (HTLV-1) that infects lymphocytes (white blood cells)     called T-cells. Cancerous cells can be found not only in the blood, but also in the skin,     lungs, lymph nodes, liver, bone, bone marrow, spleen, and meninges (tissues covering the     brain). There are four categories of ATL, based on the aggressiveness of disease-smoldering,     chronic, lymphoma, and acute. Campath-1H is a monoclonal antibody that attaches to and kills     normal and cancerous lymphocytes, including T cells. Although Campath-1H is an experimental     drug for treating ATL, it is approved by the Food and Drug Administration for treating     chronic lymphocytic leukemia.      Patients 18 years of age and older with any type of ATL except smoldering may be eligible for     this study. Candidates are screened with a medical history and physical examination, photos     of skin lesions, measurement of lesions such as lymph nodes and skin nodules, blood and urine     tests, electrocardiogram (EKG), chest x-ray, computed tomography (CT) scan or ultrasound of     the abdomen, skin biopsy, bone marrow aspirate and biopsy, skin test, and lumbar puncture     (spinal tap). Participants undergo treatment in two phases, as follows:        -  Dose escalation phase: Patients receive an infusion of Campath-1H daily for three days.          The initial dose is low and is increased daily as long as there are no side effects, or          only mild reactions, until the patient is receiving the maximum dose of 30 milligrams          per day.        -  Stable dose phase: Patients receive infusions of Campath-1H 30 mg three times a week for          up to 12 weeks.      In addition to treatment, patients are evaluated with the following tests and procedures:        -  History and physical examination every 4 weeks.        -  Blood tests every 4 weeks.        -  CT scans to measure the size of the tumors every 4 weeks.        -  Skin biopsies (if skin disease is present) and lymph note aspirates: Up to five biopsies          and five aspirates may be taken to help diagnose the disease and evaluate the effect of          Campath-1H on the cancer.        -  Bone marrow biopsy: This procedure may be done to document or monitor disease progress.      Patients receive treatment for up to 12 weeks. Treatment may stop earlier if the patient     achieves a complete response before the end of 12 weeks. Patients completing the study are     followed periodically with a history and physical examination, blood and urine tests, tumor     evaluation, skin biopsy and skin testing. They are seen monthly at first and then at 3-month     intervals the first year; every 4 months the second year, every 6 months for the third     through fifth years, and then yearly.   "
169815|NCT00061061|"     The purpose of this study is to evaluate the effects of ERT on appetitive behavior and     withdrawal in short-term smoking cessation compared to smoking ad lib in postmenopausal     female smokers.   "
169816|NCT00061074|"     The purpose of this study is to evaluate the effects of ERT on appetitive behavior and     withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine     replacement   "
169821|NCT00061139|"     Pediatric Constraint-Induced (CI) Movement therapy is a rehabilitation program designed to     improve motor function in children with partial paralysis. Children with cerebral palsy may     have one arm that has significantly greater function (good arm) than the other (bad arm).     Restricting the use of the good arm may improve the use of the bad arm. In pediatric CI     therapy, the good arm is put in a sling to force increased use of the bad arm. The bad arm is     also trained each day for several weeks. This study will test the ability of pediatric CI     therapy to improve motor function in children with cerebral palsy.   "
169822|NCT00061152|"     The purpose of the study is to gain initial information on the tolerability and feasibility     of high-concentration capsaicin patches for the treatment of painful HIV-associated     neuropathy, whether resulting from HIV disease and/or antiretroviral drug exposure. The study     will also provide preliminary safety and efficacy information.   "
169845|NCT00061464|"     The purposes of this study are to determine:        1. The safety of pemetrexed plus Gemcitabine and any side effects that might be associated          with the combination of these two drugs.        2. Whether pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer          live longer.        3. Whether pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how          long.        4. To see if patients feel better while taking pemetrexed plus Gemcitabine.   "
169848|NCT00061503|"     The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic     Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle     glaucoma (OAG) or ocular hypertension (OHT).   "
169823|NCT00061165|"     Obesity is the second leading preventable cause of disease and death in the United States.     Low socioeconomic status (SES) and minorities are disproportionately affected. Obesity     prevention among children and adolescents is a public health priority. Schools have been     identified as key settings for obesity prevention; however, most health education     interventions have had only a moderate effect on body weight. We propose a randomized     intervention trial (pilot study) to test the feasibility and effectiveness of a school-based,     environmental obesity prevention program in urban low-SES African American students. Schools,     students and their families, and local communities will be involved to promote healthy eating     and physical activity (HEPA) for prevention of childhood obesity. Six Chicago public schools     will be randomly assigned as intervention (4 schools) and controls (2 schools). Focus group     studies will assess needs and barriers for promotion of HEPA and guide the intervention. The     intervention group will receive a School Environment Enrichment (SEE) program to modify the     school physical and social environment, targeting food service, recess, physical education     (PE) and school climate, and a Community Support & Environment Modification (CSEM) program,     involving local corner and chain grocery stores to promote healthy eating among students and     their families. Family involvement will be included for 5th and 6th graders, who will be     followed for two years, to test ways to modify family environment. To assess the intervention     effectiveness, multilevel data will be collected from schools (eg, food service, recess and     PE), students (eg, body weight, eating and physical activity), parents (eg, family food     purchasing practices) and communities (eg, available choices of snack foods in local stores).     In addition, process evaluation data will be collected to assess the feasibility and     acceptance (participation and satisfaction) of various intervention components by the target     audience. The primary outcome variable is change in students' body weight status; secondary     outcomes include changes in students' eating behavior and physical activity and changes in     target environmental factors. In addition, cost-effectiveness of the intervention will be     determined. If the intervention proves effective, a full-scale study will be developed.     Findings from this study will provide insights into the prevention of obesity among low-SES     and minority students.   "
169824|NCT00061178|"     The purpose of this study is to determine whether rhuMAb VEGF (Bevacizumab) is safe and     effective for the treatment of renal cell cancer when other treatments have failed.   "
169825|NCT00061204|"     This study will use magnetic resonance imaging (MRI) to identify brain regions involved in     performing certain tasks, especially those involving emotions. MRI is a diagnostic tool that     uses a strong magnetic field and radio waves to produce images of structural and chemical     changes in the brain. The study will also examine which MRI techniques are best to use when     scanning brain areas involved in different emotions.      Healthy normal volunteers between 18 and 40 years of age who are right-handed and are native     English speakers may be eligible for this study. Individuals with a history of neurological     disease, post-traumatic stress disorder or other psychiatric disorder, or who have a history     of physical or sexual abuse may not participate. Candidates will be screened with a written     questionnaire and a medical history, including psychiatric and neurological information.      Participants will perform tasks involving emotions while undergoing MRI scanning. For this     procedure, the subject lies on a table in a narrow metal cylinder (the scanner) containing a     magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting     between 45 and 90 minutes. The subject is asked to lie still for up to 10 minutes at a time.     During the scan, the subject performs simple tasks involving the viewing of pictures on a     screen. Other tasks involve viewing pictures and responding to them by pressing buttons. Some     pictures are violent or pornographic, while others are pleasant to view. Of a total of 162     pictures, 30 percent are categorized as graphic and possibly disturbing.   "
169826|NCT00061217|"     People who have had a leg amputated often choose to use a prosthetic (artificial) leg. This     study will evaluate a new method of making prosthetic legs for people who have had an     amputation below the knee.   "
169827|NCT00061230|"     This study will examine the effectiveness of relaxation training for providing pain relief     and improving physical and psychological functioning in youth with physical disabilities due     to cerebral palsy.   "
169828|NCT00061243|"     This study will evaluate the safety of and immune response to a new HIV vaccine. The vaccine     in this trial uses pieces of HIV DNA and HIV proteins. The vaccine itself cannot cause HIV     infection or AIDS.   "
169829|NCT00061256|"     Alendronate is a drug that is used to treat osteoporosis. The purpose of this study is to     examine whether alendronate in combination with calcium and vitamin D is safe and effective     for treating bone loss in people with HIV.   "
169830|NCT00061269|"     The VARD (Videoendoscopic Assisted Retroperitoneal Drainage) approach as treatment for     necrotizing pancreatitis proposes an alternative to standard complicated open abdomen     treatment methods.      This treatment involves making a small incision and looking inside the abdomen with a     videoendoscope. A videoendoscope is an instrument with a small camera and light on the end.     It also has an extension tool that the surgeon can use to clean out any dead and infected     tissue in the abdomen.      This approach may reveal a treatment opportunity with faster recovery potential and shorter     hospitalizations for patients with necrotizing pancreatitis.   "
169844|NCT00061451|"     The purposes of this study are to determine:        1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated          with the combination of these two drugs.        2. Whether Pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer          live longer.        3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how          long.        4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.   "
169831|NCT00061282|"     Colectomy with creation of an ileal pouch (IPAA) is now the treatment of choice for patients     with ulcerative colitis that is resistant to existing medical therapies. The development of     inflammation in these ileal reservoirs, a clinical entity referred to as pouchitis, is the     most common long-term complication of this procedure and can affect 50-60% of adults and     children. We have previously demonstrated that clotrimazole (delivered as a rectal     suppository) is generally safe, effective, and displays poor systemic absorption when used in     pediatric and adults with active pouchitis. We saw clinical benefit in patients with pouch     disease that had previously failed to respond to standard antibiotic, steroid, or     immunosuppressive therapies. The clinical trial outlined here will define the effectiveness     and safety of topical clotrimazole therapy (delivered as a rectal enema) in pediatric (aged     greater than two years) and adult patients with pouchitis.      Subjects in this study will be randomly assigned to receive either placebo (no active drug, 4     subjects) or one of two clotrimazole therapy groups: 2500 mg/day (8 subjects) or 4000mg/day     (8 subjects). No washout period is required, and subjects will be allowed to continue their     existing anti-inflammatory medications during their participation in the study. Clotrimazole     will be delivered nightly in the form of an enema. Subjects will undergo flexible     sigmoidoscopy (pouchoscopy) prior to and again after completing one month of study therapy,     and pouch disease activity will be graded at after each procedure using the Pouchitis Disease     Activity Index (PDAI). Clinical improvement will be defined as a drop in PDAI score. If the     drop in PDAI scores between placebo and either active clotrimazole treatment group is not     significant, and no subject experiences what are determined to be study-related adverse     effects, a second cohort of subjects will be recruited and studied after receiving one month     of either placebo (4 subjects), 6000 mg/day clotrimazole (8 subjects), or 7500mg/day     clotrimazole (8 subjects).      Subjects will be assessed for adverse effects at the midpoint of the study. Clotrimazole     blood levels will be measured during the first and last day of study participation. In     addition, adults will complete a health related quality of life assessment at baseline and     after completing study drug therapy.      All subjects will be eligible for one month of open-label study drug therapy after completing     one month of study drug therapy.   "
169832|NCT00061295|"     Body weight support (BWS) treadmill training uses an overhead harness to give partial support     to patients walking on a treadmill. This study will determine whether BWS training is more     effective than conventional rehabilitation therapy in improving walking ability in patients     with spinal cord injuries (SCI).   "
169846|NCT00061477|"     The purposes of this study are to determine:        1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated          with the combination of these two drugs.        2. Whether Pemetrexed plus Gemcitabine can help patients with mesothelioma live longer.        3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how          long.        4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.   "
169835|NCT00061334|"     The purpose of the protocol is to localize the neural regions and systems mediating the forms     of knowledge representations hypothesized by the principal investigator to be stored in the     human prefrontal cortex. Utilizing a variety of experimental neuropsychological tasks during     functional MRI, we will investigate hypotheses regarding the role of the dorsolateral and     ventromedial prefrontal cortex in social cognition and emotional processing. We will     ascertain the relationship between so-called cold cognition such as event knowledge and hot     social cognition such as attitude formation and specific brain regions within the prefrontal     cortex. We will also attempt to determine the relationship between non-frontal neural     structures involved in emotional expressions, such as amygdala, and those frontal neural     structures involved in executive functions that may modulate emotion. The data that we     collect in this protocol will be of value in (1) identifying a set of neural regions and     distributed networks mediating the forms of knowledge representation stored in the prefrontal     cortex and (2) developing functional MRI screening measures for subjects at-risk for     developing a neurological disorder. We will also use the data obtained in these studies with     healthy adult volunteers to constrain theories of frontal lobe function based on the study of     patients with focal or diffuse frontal lobe lesions and to provide convergent evidence for     the role of specific frontal cortex sectors in specific cognitive functions.   "
169836|NCT00061347|"     To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the     prostate gland during radiation therapy. To help improve this view, doctors may insert gold     markers called fiducials into the prostate by placing hollow gold needles through the rectum     and moving a fiducial through each needle. The purpose of the study is to determine whether     an MRI scan can help doctors improve their placement of these needles.      Fifteen men will participate in this study. Patients will take the antibiotic levofloxacin     for two days prior to the placement of the fiducials, then will have a small enema and     another dose of the antibiotic on the morning of the procedure. After being anesthetized,     patients will have an antenna-like tube placed into the rectum and have MRI images taken of     the area. The doctor will then use these scans to place four fiducials into the prostate. The     procedure will require approximately 45 minutes. Patients will be allowed to go home the same     day of the procedure, which will be followed by a seven-week course of standard radiation     therapy.      Prior to their participation in this study, patients will undergo the following evaluations:     a physical exam, blood work, urine tests, and, if appropriate, an MRI or bone scan.   "
169837|NCT00061360|"     Severe aplastic anemia (SAA) is a life-threatening bone marrow failure disorder characterized     by pancytopenia and a hypocellular bone marrow. Allogeneic bone marrow transplantation and     immunosuppressive treatment with anti-thymocyte globulin (ATG) and cyclosporine (CsA) have     dramatically changed the natural course of this illness, with 5 year survival of 75% in     patients undergoing either treatment. Since most patients are not suitable candidates for     hematopoietic stem cell transplantation (HSCT) due to advanced age or lack of a     histocompatible sibling, efforts at NHLBI have focused on improving immunosuppression     treatment in order to improve response rates, survival, and to decrease relapse.      In our experience of 122 patients treated at NHLBI with the combination of ATG and     cyclosporine, one quarter to one third did not respond; about 50% of responders relapsed; and     5 year survival was correlated with the robustness in blood cell count improvement at 3     months (reticulocyte or platelet count greater than or equal to 50,000 /uL). Why some     patients do not respond initially while others relapse is unclear. Autoreactive T cells may     be resistant to the effect of ATG/CsA (nonresponders), while in others residual autoreactive     T cells expand post-treatment leading to hematopoietic stem cell destruction and recurrent     pancytopenia (relapse). Therefore, novel immunosuppressive regimens to increase response     rates and hematologic recovery at 3 months and to decrease relapse rates are needed. An     ongoing NHLBI trial, which is close to completing accrual, has added mycophenolate mofetil     (MMF) for a total of 18 months to standard ATG + CsA in an attempt to reduce the relapse rate     after cyclosporine is discontinued. Preliminary results have been disappointing, with no     marked reduction in relapse among patients who received MMF.      Sirolimus (rapamycin, Rapamune , RAPA) is a novel immunosuppressive agent, which acts     synergistically with cyclosporine by blocking T cell activation through CsA-resistant     pathways. The potentiation of the combination of CsA-RAPA has been established in vitro and     in the clinical setting, mainly in islet cell and solid organ transplantation. The     significant increase in response rate seen with the addition of CsA to ATG indicated that an     inhibitory effect on T lymphocytes is important in blocking autoreactive T cells in aplastic     anemia. The combination of CsA-RAPA may further block activated autoreactive T cells and     therefore lead to improved response rates (and survival) and decreased relapse rates.      This prospective randomized phase II study will investigate two different immunosuppressive     regimens in patients with severe aplastic anemia who have not received prior     immunosuppressive therapy. One arm will receive ATG + CsA in addition to sirolimus for 6     months, and the second arm will receive standard ATG + CsA for 6 months followed by a slow     taper of CsA with a 25% dose reduction every 3 months for the subsequent 18 months. This     trial will determine the effectiveness of sirolimus in patients with aplastic anemia as well     as the role of a cyclosporine taper in preventing relapses. Primary endpoint will be no     longer meeting criteria for severe aplastic anemia while secondary endpoints are relapse,     robustness of hematologic recovery at 3 months, survival, clonal evolution to PNH,     myelodysplasia and acute leukemia.      10/11/2005. The Sirolimus (Rapamune) arm of the trial was stopped for lack of efficacy. The     study will continue as a single arm study to establish if slow taper of CsA prevents relapse     rates after initial standard treatment with ATG followed by CsA for six months....   "
169838|NCT00061373|"     Ischemic stroke is caused by a blood clot that blocks the flow of blood to the brain and     damages brain cells. The clot, or thrombus, is made up of platelets and fibrin. The medicine     alteplase, also known as tPA , is the standard drug used to treat patients with acute     ischemic stroke. tPA attacks the fibrin portion of the blood clot. While intravenous (iv) tPA     alone is effective in treating the fibrin part of the clot approximately 30% of the time,     adding other commercially available drugs such eptifibatide to treat other clot components     may improve the effectiveness of iv tPA therapy.      This is a clinical trial to determine an acceptable dose of eptifibatide in combination with     aspirin, the low molecular weight heparin tinzaparin, and standard iv tPA therapy for the     treatment of acute ischemic stroke. Use of clinical and imaging based selection criteria are     hypothesized to contribute to treatment safety by selecting patients at lower risk of     intracerebral hemorrhage. Also,selection and evaluation of patients by magnetic resonance     imaging (MRI) criteria will result in a different risk to benefit ratio than selecting     patients without MRI criteria and will lead to a different acceptable dose.   "
169839|NCT00061386|"     This study will evaluate a community-based program to improve diet and physical activity in     women during the first 12 months following the birth of a child. The program is designed to     complement existing federal programs for low-income families and is directed toward     low-income, postpartum, multi-ethnic women.   "
169840|NCT00061399|"     Prospective memory (PM) is memory to complete future tasks, such as recalling to give a note     to someone when you next see them, pick up milk on the way home, or remembering to keep an     appointment. This study will evaluate PM in children with traumatic brain injury (TBI).   "
172406|NCT00089648|"     The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in     patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab     (Avastin) -based treatment.   "
169849|NCT00061516|"     The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT in     pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve     weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at     each visit. Patients will have a dilated fundus exam and corneal measurements taken at first     and last visit.   "
169850|NCT00061529|"     The primary objective of this study is to compare the safety and efficacy of Brimonidine     Tartrate Ophthalmic Solution, 0.15% in patients with open-angle glaucoma or ocular     hypertension.   "
169851|NCT00061542|"     The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol     Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8     pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure     and pulse checks at each visit. Patients will have a dilated fundus exam and corneal     measurements taken at first and last visit.   "
169852|NCT00061568|"     People with severe congenital anemias, such as sickle cell anemia and beta-thalassemia, have     been cured with bone marrow transplantation (BMT). The procedure, however, is limited to     children younger than the age of 16 because the risks are lower for children than for adults.      The purpose of this study is to explore the use of a BMT regimen that, instead of     chemotherapy, uses a low dose of radiation, combined with two immunosuppressive drugs. This     type BMT procedure is described as nonmyeloablative, meaning that it does not destroy the     patient s bone marrow. It is hoped that this type of BMT will be safe for patients normally     excluded from the procedure because of their age and other reasons.      To participate in this study, patients must be between the ages of 18 and 65 and have a     sibling who is a well-matched stem-cell donor. Beyond the standard BMT protocol, study     participants will undergo additional procedures. The donor will receive G-CSF by injection     for five days; then his or her stem cells will be collected and frozen one month prior to     BMT. Approximately one month later, the patient will be given two immune-suppressing drugs,     Campath 1-H and Sirolimus, as well as a single low dose of total body irradiation and then     the cells from the donor will be infused.      Prior to their participation in this study, patients will undergo the following evaluations:     a physical exam, blood work, breathing tests, heart-function tests, chest and sinus x-rays,     and bone-marrow sampling.   "
169853|NCT00061581|"     Bone marrow transplantation (BMT) is a risky procedure. If doctors could reduce the     complications, BMT would be safer to use for a wider range of conditions. The purposes of     this study are        -  to prevent graft rejection by increasing the amount of immunosuppression and by giving          some lymphocytes from the donor before transplant;        -  to prevent graft-versus-host disease (GVHD) by transplanting T-cell depleted stem cells;        -  to improve the immune effect against residual leukemia by the add-back of donor          lymphocytes before transplant and six or more weeks after transplant.      Beyond the standard transplant protocol, study participants will undergo additional     procedures. First, along with total body irradiation, patients will receive two drugs (a high     dose of cyclophosphamide and fludarabine) to suppress immunity and prevent rejection of the     transplant. Second, four days before the transplant, patients will be given donor lymphocytes     that have been irradiated to make them incapable of causing GVHD. On the day of the     transplant, patients will receive an infusion of T-cell depleted bone marrow stem cells.     Finally, patients will receive two doses of add-back donor T-cells (45 and 100 days post     transplant) and the immunosuppressive drug cyclosporine starting on day 44 until about six     months after transplant.      Study participants must be between the ages of 10 and 56 and have a family member who is a     suitable stem cell donor match.   "
169854|NCT00061594|"     This is a phase III, multicenter, randomized, double-masked, active treatment-controlled     study of intravitreally administered ranibizumab compared with verteporfin (Visudyne)     photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.   "
169855|NCT00061607|"     Spinal muscular atrophy (SMA) is a disorder that affects the motor neurons. SMA is caused by     a mutation in a part of the DNA called the survival motor neuron (SMN1) gene, which normally     produces a protein called SMN. Because of their gene mutation, people with SMA make less SMN     protein, which results in the loss of motor neurons. SMA symptoms may be improved by     increasing the levels of SMN protein. The purpose of this study is to determine whether a     drug called a histone deacetylase inhibitor can increase SMN levels.      After undergoing a general medical and neurological evaluation, study participants will     donate a blood sample. Researchers will use this sample to measure SMN levels. They will also     isolate cells from the blood and treat the cells with various drugs that may increase SMN     levels.   "
169856|NCT00061620|"     The goal of this clinical research study is to find the highest dose of Tezacitabine (FMdC)     which can be safely given as a continuous infusion by vein to patients with hematologic     malignancies. The general safety and effectiveness of this drug will also be studied.   "
169857|NCT00061633|"     Serious infections caused by resistant bacteria are becoming more of a medical problem     throughout the world. One of the ways to deal with this problem is to develop new drugs that     can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control     infections and whether this drug can be safely given to patients.   "
169858|NCT00061646|"     The primary objective of this Phase II study is to assess the safety, pharmacokinetics and     effectiveness of ABT-510 in combination with standard carboplatin/paclitaxel chemotherapy in     subjects with stage IIIb or IV NSCLC.   "
169859|NCT00061659|"     The primary objective of this study is to assess the safety and effectiveness of ABT-510 in     subjects with locally advanced or metastatic soft tissue sarcoma.   "
169860|NCT00061672|"     The primary objective of this study is to assess the safety and effectiveness of ABT-510 in     subjects with refractory lymphoma.   "
169861|NCT00061698|"     This study will compare the effectiveness of three therapies for the treatment of depression     in preadolescent girls.   "
169862|NCT00061711|"     This randomized, controlled trial will evaluate the efficacy and safety of three alternative     approaches utilizing phytoestrogens to treat hot flashes and night sweats in peri- and     post-menopausal women. The treatments were chosen because of the scientific evidence     supporting a possible benefit, the availability of products with adequate quality control,     and their frequency of use in naturopathic medicine. RECRUITMENT FOR THIS STUDY SHOULD END BY     AUGUST 1, 2003.   "
169863|NCT00061724|"     The purpose of this project is to lay the groundwork for a proposed clinical trial to compare     the effectiveness of two approaches to gastroesophageal reflux disease: treatment with     medications and treatment with anti-reflux surgery. This project includes a     non-interventional pilot study to test ways of measuring outcomes of treatment, and to gauge     potential participants' willingness to enroll in the proposed clinical trial.   "
169864|NCT00061737|"     Measurement of the quality of life (QoL) of children and adolescents with inflammatory bowel     diseases (IBD) has had little attention, despite the importance of understanding key factors     affecting QoL, especially for measuring the effects of clinical trials to improve IBD     outcomes. The main purpose of this pilot study is to examine the impact of clinical severity     and treatment social factors on the quality of life (QoL) of a diverse population of children     and adolescents with inflammatory bowel disease (IBD). Secondary purposes include determining     the effects of sociodemographic factors on QoL and exploring the concordance of views of     parents and children of QoL. The study aims are to 1) determine the associations of of     clinical characteristics (condition type, activity/severity, and treatment) with specific     components of general health-related quality of life and IBD-specific QoL; 2) describe the     effects of sociodemographic characteristics (SES, age, and gender) on these measures; and 3)     compare the views of different observers (parent and child with IBD) of the child's QoL. The     study will apply both general and condition-specific QoL measures among a random sample of     250 children and adolescents with IBD, ages 5-18 years, in six clinical sites. We will obtain     measures of QoL from both the child and a parent in each case. The study will obtain     additional data regarding the subjects' clinical condition (condition type,     severity/activity, treatment [including surgery], age of onset) and socioeconomic status     (household structure and income). Main analyses will compare general and specific measures of     QoL and examine the influence of clinical and sociodemographic variables on QoL, through     multivariate regression techniques. We will also examine the differences in child and parent     assessments of QoL. The information from this study will provide a stronger base for future     studies of treatment and natural history of IBD. It will help to clarify the life domains     that are affected by IBD and will inform interventions to improve QoL for children with IBD.   "
169865|NCT00061750|"     The purpose of this study is to deterimine if the new orally active iron chelator, ICL670, is     as effective and as safe as deferoxamine in preventing accumulation of iron in the body while     a patient is undergoing repeated blood transfusions.   "
169866|NCT00061763|"     The purpose of this study is to determine the effects of the oral iron chelator Deferasirox     on liver iron content after one year of treatment in patients with iron overload from     repeated blood transfusions. Beta-thalassemia patients unable to be treated with deferoxamine     or patients with rare chronic anemias such as Myelodysplastic Syndrome, Fanconi's Syndrome,     Blackfan-Diamond Syndrome, and Pure Red Blood Cell Anemia are eligible for this study. Liver     iron content will be measured by liver biopsy at the beginning of the study and after one     year of treatment. However, those patients living in the San Francisco/Oakland area may have     a SQUID in place of the liver biopsy if the biopsy is not medically possible for them. The     SQUID is a non-invasive magnetic means to measure liver iron content.   "
169867|NCT00061776|"     The purpose of the study is determine if an investigational drug, NGX-4010     (high-concentration capsaicin dermal patches) is effective in treating pain associated with     post-herpetic neuralgia (PHN).   "
169868|NCT00061789|"     This study will use single photon emission computed tomography (SPECT) to study brain     nicotine receptors (proteins on the surface of brain cells) in healthy subjects and in     patients with schizophrenia. Autopsy findings in patients with schizophrenia show changes in     their nicotine receptors. This study will use SPECT to look at these receptors in living     schizophrenia patients and compare them with those in healthy subjects.      The following individuals between 21 and 50 years of age (or between 21 and 80 years of age     for Group 1 only) are eligible for this study: healthy non-smokers (Group 1); schizophrenia     patients who smoke (Group 2); schizophrenia patients who do not smoke (Group 3); healthy     smokers (Group 4); healthy non-smokers (Group 5). Patients with schizophrenia must be taking     olanzapine (Zyprexa) or risperidone (Risperdal) for at least 6 months. All candidates will be     screened at the first visit. Group 1 participants will have three more visits; Groups 2     through 5 will have two more visits.      Visit 1      All participants will be screened with physical and neurological examinations; blood and     urine tests; and neuropsychological tests to assess their ability to learn and remember words     and numbers, to pay attention, and to quickly perform motor tasks, such as putting pegs into     a piece of wood. In addition, they will have an eye movement test and event-related potential     testing. For the eye test, the subject sits in a chair and leans forward with the chin on a     chin rest. A band is tied around the head and very small amounts of invisible (infrared)     light are shined into the eyes. The light is reflected back and measured. Wire electrodes are     placed around the area of the eye and cheek to monitor eye blinks and eye movements. Subjects     are asked to follow a light with their eyes and to look away from a light. For event- related     potential testing, electrodes are placed on the scalp, forehead and cheeks, and brain     activity is recorded while the subject identifies particular pictures and sounds.      Visit 2 (and Visit 3 for Group 1)      Participants will have a SPECT scan. On the night before the scan, the day of the scan, and     for 4 days after the scan, subject take an oral dose of potassium iodide to protect the     thyroid gland from the radioactive tracer used in the SPECT procedure. (Individuals allergic     to potassium iodide will take potassium perchlorate instead.) For the SPECT scan, small     radioactive markers containing 99mTc are glued to the subject's head. Two catheters (thin,     flexible tubes) are placed in veins in the arms to inject the radioactive tracer     [123I]5-I-A-85380 and to draw blood samples. During the scan, the subject lies on a bed with     his or her head held still with a headholder. The scans are taken over a 9-hour period after     injection of the tracer injection. An electrocardiogram, respiration, and blood pressure     measures are taken before injection of [123I]5-I-A-85380, then 5 minutes after the injection,     and again 30 to 60 minutes after the injection. Breath samples are collected every 60     minutes. Blood and urine samples are collected 5 to 6 hours after starting the scan. Group 1     subjects will have a second SPECT scan within 4 weeks of the first.      Visit 3 (Visit 4 for Group 1)      Participants will have a magnetic resonance imaging (MRI) scan. For this procedure, the     subject lies on a table that slides into a narrow metal cylinder with a strong magnetic field     for the scan. The scanner uses a magnetic field and radio waves to produce images that show     structural and chemical changes in tissues. The test lasts up to 1 hour.   "
169869|NCT00061802|"     A study to evaluate the efficacy and safety of two atypical antipsychotics vs. placebo in     patients with an acute exacerbation of either schizophrenia or schizoaffective disorder   "
169870|NCT00061815|"     The purpose of this study is to compare overall survival in patients with previously-treated     metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with     oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.   "
169871|NCT00061828|"     Biliary atresia and idiopathic neonatal hepatitis are the most common causes of jaundice and     hyperbilirubinemia that continue beyond the newborn period. The long term goal of the Biliary     Atresia Research Consortium (BARC) is to establish a database of clinical information and     serum and tissue samples from children with biliary atresia (BA) and idiopathic neonatal     hepatitis (INH) to facilitate research and to perform clinical, epidemiological and     therapeutic trials in these two important pediatric liver diseases.   "
169872|NCT00061841|"     This project will determine whether exposing youths to a fitogenic after-school environment     that emphasizes vigorous exercise and healthy snacks will have a favorable effect on body     composition (i.e., less fat tissue and more lean tissue), cardiovascular fitness and     cardiovascular disease risk profile. The environmental intervention will be provided in nine     schools in Augusta, Georgia, with another nine schools serving as non-intervention comparison     schools. Children in the 3rd grade will be recruited to participate. They will be followed     for 3 years, through the 5th grade. Measurements will be made at the beginning and end of     each school year. The 2-hour after-school intervention will be offered every school day. It     will consist of three components: (1) homework assistance; (2) a healthy snack; and (3)     exercise designed to improve skills and fitness.   "
169873|NCT00061854|"     RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who     have progressive locally advanced or metastatic non-small cell lung cancer.   "
169874|NCT00061867|"     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, use different ways to     stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills     tumor cells by heating them to several degrees above body temperature. Combining liposomal     doxorubicin with microwave thermotherapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of liposomal     doxorubicin when given together with microwave thermotherapy in treating patients with     prostate cancer.   "
169875|NCT00061880|"     RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for     cancer cell growth.      PURPOSE: Phase I/II trial to study the effectiveness BCX-1777 in treating patients who have     refractory cutaneous T-cell lymphoma.   "
169876|NCT00061893|"     RATIONALE: Drugs used in chemotherapy, such as vinblastine, work in different ways to stop     tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of     Ewing's sarcoma by stopping blood flow to the tumor. Combining more than one chemotherapy     drug with celecoxib may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining low-dose vinblastine and     celecoxib with standard regimens of combination chemotherapy in treating patients who have     newly-diagnosed metastatic Ewing's sarcoma family of tumors.   "
169877|NCT00061906|"     RATIONALE: Celecoxib may stop the growth of thyroid cancer by stopping blood flow to the     tumor and by blocking the enzymes necessary for tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who have     progressive metastatic differentiated thyroid cancer.   "
169878|NCT00061919|"     RATIONALE: Drugs used in chemotherapy such as carboplatin and etoposide use different ways to     stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth     of cancer by stopping blood flow to the tumor. It is not yet known if combination     chemotherapy is more effective with or without thalidomide in treating small cell lung     cancer.      PURPOSE: This randomized phase III trial is studying carboplatin, etoposide, and thalidomide     to see how well they work compared to carboplatin and etoposide in treating patients with     limited- or extensive-stage small cell lung cancer.   "
169879|NCT00061932|"     This phase II trial is studying how well bortezomib with or without irinotecan works in     treating patients with gastroesophageal junction or stomach cancer that can not be removed by     surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth. Drugs used in chemotherapy such as irinotecan use different ways to stop     tumor cells from dividing so they stop growing or die. Combining bortezomib with irinotecan     may kill more tumor cells.   "
169880|NCT00061945|"     This phase I/II trial studies the side effects and best dose of alemtuzumab when given     together with combination chemotherapy and to see how well it works in treating patients with     untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, can block     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.     Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs     used in chemotherapy also work in different ways to kill cancer cells or stop them from     growing. Giving alemtuzumab together with combination chemotherapy may be a better way to     block cancer growth.   "
169881|NCT00061958|"     This phase II trial is studying how well arsenic trioxide works in treating patients with     metastatic or unresectable cancer of the esophagus or gastroesophageal junction. Drugs used     in chemotherapy such as arsenic trioxide use different ways to stop tumor cells from dividing     so they stop growing or die   "
169882|NCT00061984|"     RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways     to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors,     such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether     doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating     soft tissue sarcoma.      PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well     it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in     treating patients with locally advanced or metastatic soft tissue sarcoma.   "
169883|NCT00061997|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Inositol may be effective in preventing the development     of lung cancer in patients with bronchial epithelial dysplasia.      PURPOSE: This phase I trial is studying the side effects and best dose of inositol in     preventing lung cancer in current or former smokers with bronchial epithelial dysplasia.   "
169884|NCT00062010|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. Some tumors become resistant to     chemotherapy drugs. Giving interferon alfa and isotretinoin together with paclitaxel may     reduce resistance to the drug and allow the tumor cells to be killed.      PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin     together with paclitaxel works in treating patients with recurrent small cell lung cancer.   "
169885|NCT00062023|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. It is not yet known whether sulindac, aspirin, or     ursodiol is more effective in preventing colorectal cancer.      PURPOSE: This randomized phase II trial is studying how well sulindac works compared to     aspirin or ursodiol in preventing colorectal cancer.   "
169886|NCT00062036|"     RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and fludarabine use different     ways to stop tumor cells from dividing so they stop growing or die. Inserting the gene for     interleukin-2 into a person's tumor infiltrating lymphocytes may make the body build an     immune response to kill tumor cells. Combining cyclophosphamide and fludarabine with     gene-modified tumor cells may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of gene-modified     tumor infiltrating lymphocytes when given together with cyclophosphamide and fludarabine and     to see how well they work in patients with metastatic melanoma (phase I is closed to accrual     3/29/06).   "
169887|NCT00062049|"     RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in     treating patients with refractory solid tumors.   "
169888|NCT00062062|"     RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer     cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and     paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die.     Combining gefitinib with carboplatin and paclitaxel may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gefitinib alone or together with     carboplatin and paclitaxel works in treating older patients with unresectable or metastatic     non-small cell lung cancer.   "
169889|NCT00062075|"     This phase II trial is studying how well romidepsin works in treating patients with relapsed     or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as romidepsin, work in     different ways to stop tumor cells from dividing so they stop growing or die.   "
169890|NCT00062101|"     This phase II trial is studying how well giving erlotinib together with celecoxib works in     treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer. Erlotinib     and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor     cell growth. Celecoxib may slow the growth of a tumor by stopping blood flow to the tumor.     Combining erlotinib with celecoxib may kill more tumor cells.   "
169891|NCT00062114|"     RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can     locate cancer cells and either kill them or deliver radioactive cancer-killing substances to     them without harming normal cells.      PURPOSE: This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan     together with rituximab works in treating patients with progressive non-Hodgkin's lymphoma.   "
173729|NCT00107965|"     The purpose of this study is to determine whether topical application of PEP005 is safe for     the treatment of actinic keratoses.   "
169892|NCT00062127|"     Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in     chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they     stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells. This     randomized phase I trial is studying the side effects and best way to give irinotecan and     thalidomide in treating patients with metastatic or unresectable solid tumors   "
169893|NCT00062140|"     RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may     decrease side effects while stopping cancer cells from dividing so they stop growing or die.     Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation     may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy     used to kill cancer cells.      PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide     combined with total-body irradiation and donor stem cell transplantation in treating patients     who have hematologic cancer.   "
169894|NCT00062166|"     Von Hippel-Lindau disease (VHL) is an inherited cancer syndrome. Patients are at risk for     developing pancreatic cysts and tumors. These tumors are more aggressive in some people than     in others. To learn more about this disease, its genetic cause and how best to treat it, this     study will 1) identify patients with VHL who have pancreatic lesions; 2) examine the     characteristics of the lesions and how fast they grow; 3) study how well imaging tests can     reveal lesion characteristics that will help in diagnosis; and 4) perform genetic studies     using blood and, when possible, tissue samples.      Patients 12 years of age and older with VHL involving the pancreas may be eligible for this     study. Participants will undergo some or all of the following tests and procedures:        -  Interviews with a cancer doctor, cancer nurses, and a surgeon (if surgery is          recommended).        -  Computed tomography (CT) scan of the abdomen, chest, or pelvis. This test uses x-rays to          produce images of body tissues and organs in small sections.        -  Magnetic resonance imaging (MRI) of the abdomen. This test uses radio waves and a strong          magnetic field to produce images of body tissues and organs.        -  Ultrasound of the abdomen. This test uses sound waves to create images body tissues and          organs.        -  Blood tests for routine laboratory chemistries, for tests specific to the pancreas, and          for genetic studies        -  24-hour urine studies      After the tests are completed, the doctor will discuss the results with the patient. Patients     with a pancreatic tumor that requires surgery will be offered the option of an operation to     remove as much tumor as possible. Patients with lesions that are not appropriate for surgery     will be asked to return to NIH for scans and x-rays every year to monitor growth of the     lesions. If surgery should become advisable in the future, the option will be discussed at     that time. Patients with pancreatic cysts will be asked to return to NIH every 2 years for     scans and x-rays to monitor their condition.   "
169895|NCT00062179|"     RATIONALE: Drugs used in chemotherapy such as paclitaxel and carboplatin use different ways     to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the     effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug, may     stop the growth of tumor cells by stopping blood flow to the tumor, and/or may block the     enzymes necessary for tumor cell growth. Giving combination chemotherapy with celecoxib     before surgery may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well giving paclitaxel together with     carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin     and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung     cancer.   "
169896|NCT00062205|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes     necessary for tumor cell growth.      PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating     patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.   "
169897|NCT00062231|"     RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective     in preventing or controlling fever and neutropenia in patients with cancer. It is not yet     known whether moxifloxacin alone is more effective than amoxicillin combined with     ciprofloxacin in treating neutropenia and fever.      PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares     it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients     with cancer.   "
169898|NCT00062244|"     This phase I/II trial is studying the side effects and best dose of oblimersen and to see how     well it works in treating patients with relapsed or refractory Waldenstrom's     macroglobulinemia. Biological therapies such as oblimersen may interfere with the growth of     the cancer cells and slow or stop the growth of Waldenstrom's macroglobulinemia.   "
169899|NCT00062257|"     RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well irofulven works in treating patients with     recurrent or metastatic gastric cancer.   "
169900|NCT00062270|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Biological therapies such as gefitinib may interfere with the growth of the tumor cells and     slow the growth of the tumor. Combining chemotherapy and radiation therapy with gefitinib     before surgery may shrink the tumor so that it can be removed during surgery.      PURPOSE: Phase I/II trial to compare the effectiveness of neoadjuvant chemoradiotherapy with     or without gefitinib in treating patients who are undergoing surgery for stage III non-small     cell lung cancer.   "
169901|NCT00062283|"     RATIONALE: Drugs used in chemotherapy such as alanosine use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well alanosine works in treating patients with     soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or     pancreatic cancer.   "
169902|NCT00062296|"     RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop cancer     cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can     locate cancer cells and either kill them or deliver cancer-killing substances to them without     harming normal cells. Combining epirubicin with rituximab may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with rituximab in     treating patients who have relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic     lymphocytic leukemia.   "
169903|NCT00062309|"     RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill     tumor cells. It is not yet known which radiation therapy regimen is more effective in     treating prostate cancer.      PURPOSE: This randomized phase III trial is comparing two different regimens of radiation     therapy to see how well they work in treating patients with stage II or stage III prostate     cancer.   "
169926|NCT00062634|"     The female condom offers women a potentially important option for HIV prevention. This study     will develop and evaluate a health education program to increase female condom use among     ethnically diverse women.   "
180400|NCT00186290|"     To evaluate the role of ablative allogeneic hematopoietic cell transplantation in the     treatment of advanced leukemia or lymphoma.   "
169904|NCT00062322|"     RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Irinotecan and cisplatin may also make the tumor     cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy     before surgery may shrink the tumor so that it can be removed during surgery.      PURPOSE: This phase I trial is studying the side effects of neoadjuvant radiation therapy     given together with irinotecan and cisplatin followed by surgery in treating patients with     limited-stage small cell lung cancer.   "
169905|NCT00062335|"     RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan     treatment may enable doctors to provide more effective radiation therapy that will cause less     damage to normal tissue.      PURPOSE: This phase I trial is studying the side effects and best dose of high-dose     3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage     II, or stage IIIA non-small cell lung cancer.   "
169906|NCT00062348|"     RATIONALE: Diagnostic procedures using boronophenylalanine-fructose complex (BPA-F) and/or     sodium borocaptate (BSH) to detect the presence of boron in tumor cells may help determine     whether patients who have thyroid cancer, head and neck cancer, or liver metastases may     benefit from boron neutron capture therapy.      PURPOSE: This phase I trial is studying the side effects of giving BPA-F and/or BSH before     surgery to detect boron uptake in tissues of patients with primary, metastatic, or recurrent     thyroid cancer, head and neck cancer, or liver metastases from colorectal cancer.   "
169907|NCT00062374|"     This phase II trial is studying how well giving irinotecan together with cisplatin works in     treating patients who are undergoing surgical resection for locally advanced cancer of the     stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than one chemotherapy drug and giving them before surgery may shrink the     tumor so that it can be removed during surgery.   "
169908|NCT00062387|"     Phase II trial to study the effectiveness of perifosine in treating patients who have     recurrent or metastatic head and neck cancer. Drugs used in chemotherapy such as perifosine     use different ways to stop tumor cells from dividing so they stop growing or die.   "
169909|NCT00062400|"     RATIONALE: Adjuvant therapy given after surgery for early breast cancer may cause     infertility. Assessing young women's attitudes and feelings about the risk of infertility may     help improve the ability to plan effective treatment.      PURPOSE: This clinical trial is studying young women's attitudes and feelings about the risk     of infertility related to adjuvant therapy for stage I or stage II breast cancer.   "
169910|NCT00062426|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and     capecitabine, work in different ways to stop tumor cells from dividing so they stop growing     or die. Combining more than one drug and giving them in different combinations may kill more     tumor cells. Monoclonal antibodies, such as bevacizumab (Avastin™), can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet     known which regimen works better in treating advanced colorectal cancer.      PURPOSE: This randomized phase III trial is to see if oxaliplatin and bevacizumab work better     when combined with either fluorouracil and leucovorin or capecitabine in treating patients     who have metastatic or recurrent colorectal cancer.   "
169911|NCT00062439|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, use     different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Combining cisplatin and etoposide with     radiation therapy may shrink the tumor so it can be removed by surgery. Giving docetaxel     after surgery may kill any remaining tumor cells.      PURPOSE: This phase II trial is studying how well giving chemoradiotherapy together with     cisplatin and etoposide followed by surgery and docetaxel works in treating patients with     newly diagnosed Pancoast tumors, a type of non-small cell lung cancer.   "
169912|NCT00062452|"     Feeding difficulties and airway related consequences contribute significantly to the infant     mortality and morbidity. Some of these problems may be dependent on neural control and     muscular function. Prematurity, congenital anomalies and perinatal depression represent three     important conditions in infants, that may have feeding and airway difficulties.Development of     motility of the foregut and the adaptation during normal and disease in developing infants is     unclear.   "
169913|NCT00062465|"     Various forms of the plant extract Tripterygium wilfordi Hook F (TwHF) have been used in     China as a remedy for inflammatory diseases, including rheumatoid arthritis. The purpose of     this study is to investigate how tolerable, safe, and effective TwHF is for patients with     rheumatoid arthritis. Investigators will compare the therapeutic effects of TwHF with     Sulfasalazine, an FDA-approved drug for arthritis.      Participants in this 24-week study must have had active rheumatoid arthritis for at least six     months. Approximately 120 patients will participate. Participants will be assigned to one of     two drug-treatment groups, TwHF or Sulfasalazine. They will be given the study drug at each     of six clinic visits and will be asked to take two capsules three times each day with meals     and water. During the clinic visits, investigators will obtain multiple blood samples; give     physical exams; assess swollen, tender, and painful joints; and administer x-rays.      Study participants will be compensated up to $260 for their involvement in this study.   "
169914|NCT00062478|"     The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a     treatment of adults with brain tumors.   "
169915|NCT00062491|"     The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as     a treatment for Malignant Melanoma.   "
169916|NCT00062504|"     To analyze the effect of Talampanel on progression free survival in patients with recurrent     high grade gliomas.   "
169927|NCT00062647|"     The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety     administered to patients with bloodstream infections and whether telavancin is effective in     treating these infections.   "
170153|NCT00064636|"     The purpose of this study is to evaluate how safe VELCADE (PS-341) is when given with     Taxotere (Docetaxel) to patients with non-small cell lung cancer or other solid tumors, and     also to see what effects (good and bad) it has on you and your cancer.   "
169917|NCT00062517|"     The purpose of this study is to increase researchers understanding of the biological basis of     generalized anxiety disorder and social anxiety disorder. They will investigate how the brain     activity associated with specific thoughts and feelings may play a role in these anxiety     disorders. This knowledge will be used to design interventions to help those with these     illnesses.      To qualify for this study, participants must be evaluated via an initial telephone screening     interview and material sent through the mail.      Participants will then be required to make three visits to NIH. During the first visit, they     will be asked questions about their general mood, degree of nervousness, thinking skills, and     behavior. They will undergo a thorough physical exam, including an EKG, blood work,     urinalysis, and a pregnancy test for women of childbearing potential. During the second     visit, participants will spend about 2.5 hours doing various tasks while sitting and looking     at a computer screen. These tasks will guide them to experience specific kinds of thoughts     and emotions. Researchers will attach electrodes to the participants hands to monitor the     amount of electricity conducted by the skin. The third visit will be similar to the second     visit, but participants will perform the tasks while lying in a MRI scanner.      Participants will be compensated up to $400 for their involvement in this study.   "
169918|NCT00062530|"     This study will test the safety of and immune response to an oral HIV vaccine in healthy     volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to     deliver an HIV gene into the body through the mouth. The body then produces an HIV protein     from the gene; this protein stimulates an anti-HIV immune response. The vaccine contains only     one of the many substances that HIV needs to make more copies of itself, so the vaccine     itself cannot cause HIV or AIDS.   "
169919|NCT00062543|"     The primary objective is to determine whether donor stem cells administered via hepatic     artery infusion can produce liver cells in patients with severe hepatic dysfunction post stem     cell transplantation (SCT) and the safety of this procedure. The secondary objective is to     improve liver function and improve survival.   "
169920|NCT00062556|"     The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses,     compared to diet control (this group will receive a tablet containing 50 mg. of     immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused     by a narrowing of their leg arteries, a condition called intermittent claudication.      At least 366 subjects with leg pain caused by a narrowing of their leg arteries will     participate in this study.      Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration)     approved cholesterol modifying medications: Niaspan® (extended-release niacin) and     lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved     by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The     use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic     relief of intermittent claudication is considered investigational. An investigational use is     one that is not approved by the FDA.   "
169921|NCT00062569|"     This study will evaluate the effectiveness of a 3-week reminiscence intervention applied     during bathing persons with Alzheimer's disease (AD) in decreasing resistiveness to care     (RTC), relieving patient discomfort, and improving spouse caregiver appraisals of burden,     capabilities and confidence while bathing the patient. Reminiscence provides opportunities     for the patient to feel good and recall pleasant memories, easily done by caregivers in a     home setting. Home visits and telephone calls from trained nurses provide coaching and     practice for caregivers for the preliminary phase of this study. Each couple will be enrolled     in the study for approximately 9 weeks. The study will recruit 100 patient/spouse caregiver     couples randomly divided into one of two groups: reminiscence with coaching, or bathing     support (control). Bathing support will be provided to participants in both conditions     including: individualized assessment; education regarding bathing techniques for people with     dementia; and individualized problem solving. In addition to the bathing support     intervention, participants in the experimental group will receive a pleasant memories     interview and reminiscence script with coaching for implementation. Caregivers will keep a     journal of their experiences in bathing the care recipient.   "
169922|NCT00062582|"     The aim of the study is to compare the effect of roflumilast and placebo on the lung function     in patients with COPD.   "
169923|NCT00062595|"     This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study     supplementation effects on bone turnover and bone density. Women at least 5 years     postmenopause with normal bone density who do not use estrogen therapy or the following     medications may be eligible:      alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel),     zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin     (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will     take calcium and vitamin D (Citracal) twice a day for the first two months and through-out     the study. After the first two months, subjects are randomized to the K1, MK4 or placebo     groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at     each visit and bone density is performed at 3 study visits.   "
169924|NCT00062608|"     The aims are to evaluate: (1) the effectiveness of written self-disclosure (WSD) on health     status of youth ages 12-18 with functional recurrent abdominal pain (RAP); (2) whether     effectiveness of WSD is similar for younger (12-14) and older (15-18) youth with functional     RAP; and (3) the feasibility and acceptability of WSD when extended to the pediatric health     care setting.We will implement a randomized, controlled trial (RCT) designed to compare     health status in 140 youths (ages 12-18) with functional RAP assigned either to standard     medical care (SMC) or WSD provided in the health care setting in addition to SMC. Health     status will be measured at Baseline and 3- and 6-months thereafter. Primary measures of     health status are symptom severity and episode frequency, consistent with the definition of     RAP. Secondary measures of health are functional health, psychological distress,     health-related quality of life, and health care utilization. Total use and diagnostic tests     will index health care utilization, collected for the 6-mos prior to and following Baseline.     Mixed model ANOVA or MANOVA will be used to test directional hypotheses corresponding to the     specific aims.   "
169925|NCT00062621|"     The purpose of this study is to determine whether a combined bone marrow and kidney     transplant will be effective in treating stage II or greater multiple myeloma and associated     kidney failure. This study will determine whether transplant rejection and the need for     immunosuppressive drugs are decreased with this combined transplant approach.   "
169928|NCT00062660|"     To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir     combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have     failed or are intolerant to currently approved treatments for HIV infection, who are unable     to participate in another tipranavir controlled clinical trial and have an urgent need for     anti-HIV treatment.   "
169929|NCT00062673|"     A study of the safety and efficacy of duloxetine in elderly patients (greater than 65 years     old) with major depressive disorder   "
169930|NCT00062686|"     This study was designed to determine the efficacy of an oral dual kinase inhibitor for the     treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a     refractory patient population.   "
169931|NCT00062699|"     To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for     the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney     disease on hemodialysis as measured by time to death.   "
169932|NCT00062712|"     Patients with renal failure need chronic dialysis or a kidney transplant to survive. Most     kidney transplant patients must take medicines indefinitely to prevent their immune systems     from rejecting the kidney. Long-term exposure to these anti-rejection medicines can damage     the transplanted kidney.      The purpose of this study is to determine whether giving patients cells from the donor's bone     marrow will reduce or eliminate the need for long-term use of these anti-rejection drugs. In     addition to the donor's bone marrow cells, patients will receive the drugs thymoglobulin and     sirolimus.      A total of 20 patients will participate in this five-year study.   "
169933|NCT00062738|"     The goal of this study is to evaluate the effectiveness and safety of two     antidepressants--nortriptyline and paroxetine, compared to placebo in patients with     Parkinson's disease and depression.   "
169934|NCT00062751|"     To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules     of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole,     compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer     in postmenopausal women. All patients must be appropriate to receive endocrine therapy as     treatment for advanced disease.   "
169935|NCT00062764|"     Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic     hepatitis but occurs in persons who drink little or no alcohol. The etiology of NASH is     unclear, but it is commonly associated with diabetes, obesity, and insulin resistance.     Several pilot studies, including a study of pioglitazone at the NIH Clinical Center     (01-DK-0130), have shown that the insulin-sensitizing thiazolidinediones lead to decreases in     serum alanine aminotransferase (ALT) levels and improved liver histology. Once therapy is     stopped, however, ALT levels rapidly return to pre-treatment values. Inaddition we are     currently enrolling patients with NASH in a pilot study of metformin therapy for 48-weeks,     however our results in 3 patients thus far have not been very encouraging.      In the current study, patients who have completed the pilot study of pioglitazone and have     been off therapy for 48 weeks will be offered re-treatment for 3 years. We also propose to     treat patients who have not had a satisfactory response to metformin with pioglitazone for     the same duration. After a repeat medical and metabolic evaluation and liver biopsy, patients     with moderate-to-severe NASH (activity score greater than or equal to 4) will restart     pioglitazone at a dose of 15 mg daily. If after 48 weeks, ALT levels are not normal or     improved to the degree identified during the pilot study, the dose will be increased to 30 mg     daily at the end of 3 years, all patients will undergo repeat medical and metabolic     evaluation and liver biopsy. The primary end point will be improvement in liver histology.     Secondary end points will be improvements in insulin sensitivity, reduction in visceral fat,     liver volume, and liver biochemistry. The aim of this study is to evaluate whether long-term     pioglitazone therapy can safely achieve and maintain biochemical and histological     improvements in NASH.   "
169936|NCT00062777|"     Since 1948, residents of Framingham, Massachusetts, have participated in a program that     collects blood samples and clinical data to provide a rare and valuable database for     scientific research.      The purpose of this study is to support this national resource by aiding in its research     capacity. Specifically, researchers in this study will (1) investigate heart, lung, and blood     diseases; stroke; memory loss; joint disease; bone loss; deafness; cancer; blood vessel     diseases and other health conditions, and (2) examine DNA and its relationship to risk of     developing these disease and health conditions.      Approximately 330 families have participated in the Framingham Study. Participants will be     required to undergo a four-hour exam and to take that exam every two years thereafter. During     the exam, the Framingham investigators will (1) interview participants about medical status,     health issues, and lifestyles; (2) perform a regular physical exam; (3) obtain blood and     urine samples and administer a glucose-tolerance test; (4) supervise a brisk six-minute     treadmill walk; (5) administer an ultrasound procedure; and (6) review and obtain copies of     medical and hospital records. Participants will also be asked to complete a questionnaire at     home regarding dietary and health habits.   "
169937|NCT00062790|"     This study is being done to determine how much certain hormone levels in the prostate     decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male     patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill)     once daily by mouth for 3 months prior to having a surgery to reduce the size of their     prostate. During the surgery, very small pieces of the prostate that are removed will be     tested to see how much dihydrotestosterone and testosterone (male hormones) are in the     tissue.   "
169938|NCT00062803|"     Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this     study. The purpose of the study is to compare the safety and effectiveness of a new     injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a     pulmonary embolism. The standard treatment includes injections or infusions of an     anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets     (warfarin or acenocoumarol) which are taken by mouth.      Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by     chance and will be known by both patients and their doctors.   "
169939|NCT00062816|"     The purposes of this Phase 1/2 study are to examine the safety, tolerability, and antiviral     activity of ISIS 14803, when given in combination with peginterferon alfa and ribavirin, to     patients who either failed to have at least a 100-fold HCV reduction at Week 12 of standard     therapy or still have detectable HCV at Week 24.   "
169940|NCT00062829|"     The purpose of this study is to evaluate the effectiveness of a program designed to reduce     teen crashes and risky driving by increasing parental monitoring and restriction of their     adolescents' driving practices during the first year of licensed driving.   "
170154|NCT00064649|"     The primary objective of this randomized clinical trial is to determine the efficacy and     safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle     ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin     and finasteride.   "
169941|NCT00062842|"     The medicine being offered in this study is called Irinotecan. Irinotecan has been effective     against many animal cancers. It has been given to both adults and children. We are now     attempting to determine how much of the drug can be given to children when Irinotecan is     given weekly for four weeks in a row every 6 weeks and the toxicities (bad side effects) that     occur when irinotecan is administered on this schedule.      The purposes of this study are to:        1. To determine the highest dose of Irinotecan that can safely be given to children whose          cancer no longer responds to standard treatment.        2. To determine the toxicities of Irinotecan.        3. To determine what studies (laboratory or x-rays) need to be done to evaluate the          toxicities of this drug.        4. To determine if irinotecan is beneficial to the patient.        5. To understand how the drug Irinotecan works in the body.   "
169942|NCT00062855|"     This research study is designed to determine the safety and dosage of special cells that may     make a patients own immune system fight the cancer. To do this we will put two special genes     into cancer cells taken from the patients body. The genes we put in make the cancer cells     produce lymphotactin, a natural substance that attracts immune system cells to the cancer,     and IL-2 a natural substance that may help the immune system kill cancer cells. Some of these     cells will then be put back in the patient's body. Studies of cancers in animals and in     cancer cells that are grown in laboratories suggest that substances like lymphotactin and     IL-2 help the body kill cancer cells. A treatment similar to this has been used in ten     children previously and similar treatments are being used in adults with other cancers.      The purpose of this study is to learn the side effects and safe 'dosage' of these special     cells.   "
169944|NCT00062881|"     This research study is an investigational treatment with the experimental drug Mafosfamide.     This treatment is only for children with cancer that has spread to the meninges (tissues that     cover the spinal column and brain) and has continued to grow despite treatment with standard     therapy.      Mafosfamide is a drug reported to have antitumor effects in animals and that has been given     safely into the cerebrospinal fluid (the fluid within and surrounding the brain) in a small     number of children and adults. Since there is limited experience in adults and children in     giving mafosfamide in this way, the main purpose of this study is to determine the     appropriate safe dose of mafosfamide when given intrathecally, that is directly into the     cerebrospinal fluid.      The purposes for this study are to (a) determine what dose of mafosfamide can be safely given     into the cerebrospinal fluid through an Ommaya reservoir (surgically implanted catheters used     to sample cerebrospinal fluid and to instill medication into the cerebrospinal fluid) and     lumbar puncture (spinal tap) or lumbar reservoir; (b) look for side effects of drug     treatment; (c) to study the pharmacology (how the human body handles the drug) when given     directly into the spinal fluid; and (d) see if this drug is beneficial to the patient.   "
169945|NCT00062894|"     The purpose of this study is to assess the blood pharmacokinetics in patients with previously     untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma who have     received a dosimetric dose of fission-derived iodine I 131 tositumomab.   "
169946|NCT00054249|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of T900607 in treating patients who have     gastroesophageal junction cancer.   "
169947|NCT00054262|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of T900607 in treating patients who have     unresectable liver cancer.   "
169948|NCT00054275|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in     treating patients who have stage IV or recurrent breast cancer.   "
169949|NCT00054288|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with gemcitabine in     treating patients who have refractory advanced solid tumors.   "
169950|NCT00054301|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation     during surgery followed by external-beam radiation to the entire breast may kill more tumor     cells.      PURPOSE: Phase II trial to study the effectiveness of radiation therapy during surgery     followed by whole-breast radiation therapy in treating women who have undergone lumpectomy     for ductal carcinoma in situ or invasive breast cancer   "
169951|NCT00054314|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who     have non-small cell lung cancer.   "
170167|NCT00064818|"     The purpose of this study is to investigate the effect of acupuncture needling on connective     tissue using ultrasound techniques both in animals and in humans.   "
169952|NCT00054327|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's     immune system from rejecting the donor's stem cells. When the stem cells from a related     donor, that do not exactly match the patient's blood, are infused into the patient they may     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and     platelets.      PURPOSE: This phase II trial is studying how well giving chemotherapy with or without     radiation therapy followed by donor stem cell transplant works in treating patients with     hematologic cancer.   "
169953|NCT00054340|"     RATIONALE: Combining antithymocyte globulin with combination chemotherapy before donor     peripheral stem cell transplantation may reduce the chance of developing graft-versus-host     disease following transplantation.      PURPOSE: Phase I/II trial to study the effectiveness of combining antithymocyte globulin with     busulfan and cyclophosphamide in reducing graft-versus-host disease in patients who are     undergoing donor stem cell transplantation for myelodysplastic syndrome or other     myeloproliferative disorder.   "
172407|NCT00089661|"     The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects     undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.   "
169954|NCT00054353|"     This phase I/II trial studies the side effects of giving reduced-intensity conditioning     followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in     treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as     fludarabine phosphate and melphalan, and total-body irradiation (TBI) before a donor PBSCT     helps stop the growth of cancer cells. It may also stop the patient's immune system from     rejecting the donor's stem cells. The donated stem cells may replace the patient's immune     cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving mycophenolate mofetil and cyclosporine after transplant may stop this from     happening.   "
169955|NCT00054392|"     RATIONALE: Drugs used in chemotherapy such as gemcitabine, carboplatin, and paclitaxel use     different ways to stop tumor cells from dividing so they stop growing or die. Combining more     than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is     more effective in treating non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination     chemotherapy regimens in treating patients who have stage IIIB, stage IV, or recurrent     non-small cell lung cancer.   "
169956|NCT00054405|"     Phase I trial to compare the effectiveness of interleukin-12 with or without interleukin-2 in     treating young patients who have refractory or recurrent neuroblastoma. Biological therapies     use different ways to stimulate the immune system and stop cancer cells from growing.     Combining interleukin-2 with interleukin-12 may kill more tumor cells.   "
169957|NCT00054418|"     RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer     may decrease the risk of fractures and may help patients live more comfortably. It is not yet     known whether calcium is more effective with or without risedronate in preventing bone loss.      PURPOSE: This randomized phase III trial is studying two forms of calcium with or without     risedronate to compare how well they work in preventing bone loss in premenopausal women who     are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast     cancer.   "
169958|NCT00054431|"     This phase II trial is studying how well giving imatinib mesylate together with decitabine     works in treating patients with accelerated or blast phase chronic myelogenous leukemia.     Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for     cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from     dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may     kill more cancer cells   "
169959|NCT00054444|"     This phase I trial is studying the side effects and best way to give radiation therapy when     given together with topotecan and cisplatin in treating patients with locally advanced     cervical cancer. This trial is also studying the best dose of topotecan when given in this     regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from     dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill     more tumor cells.   "
169960|NCT00054457|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study of the effectiveness of combining docetaxel with     capecitabine in treating patients who have metastatic cancer of the stomach or     gastroesophageal junction.   "
169961|NCT00054470|"     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary     for tumor cell growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and     either kill them or deliver tumor-killing substances to them without harming normal cells.     Combining tipifarnib with trastuzumab may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining tipifarnib with trastuzumab     in treating patients who have metastatic breast cancer.   "
169962|NCT00054483|"     Phase I trial to study the effectiveness of bortezomib in treating patients who have advanced     cancer and kidney dysfunction. Bortezomib may stop the growth of cancer cells by blocking the     enzymes necessary for cancer cell growth.   "
169963|NCT00054496|"     RATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary     for cancer cell growth.      PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have     recurrent or progressive glioblastoma multiforme.   "
169964|NCT00054522|"     RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may     increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug.      PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone     in treating patients with prostate cancer who have undergone surgery or radiation therapy.   "
169965|NCT00054535|"     RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells.     Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.      PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with     interleukin-2 in treating patients who have metastatic melanoma.   "
170168|NCT00064831|"     The purpose of the study is to determine if black cohosh extract (BCE) administration in     symptomatic postmenopausal women results in estrogenic stimulation of the breast, as     determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid.   "
169966|NCT00054548|"     Phase I trial to study the effectiveness of combining carboplatin and paclitaxel with     oblimersen in treating patients who have advanced solid tumors. Drugs used in chemotherapy     use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen     may increase the effectiveness of carboplatin and paclitaxel by making tumor cells more     sensitive to the drugs.   "
169967|NCT00054561|"     RATIONALE: Drugs used in chemotherapy such as isotretinoin use different ways to stop tumor     cells from dividing so they stop growing or die. Interferon alfa may interfere with the     growth of tumor cells. Vitamin E may be able to decrease side effects caused by isotretinoin.     It is not yet known whether combining isotretinoin and interferon alfa with vitamin E is more     effective than observation in preventing recurrence of head and neck cancer after surgery     and/or radiation therapy.      PURPOSE: Randomized phase III trial to compare the effectiveness of isotretinoin and     interferon alfa combined with vitamin E with that of observation in treating patients who     have undergone surgery and/or radiation therapy for stage III or stage IV head and neck     cancer.   "
169969|NCT00054587|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells     and either kill them or deliver tumor-killing substances to them without harming normal     cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known     which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more     effective in treating breast cancer.      PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus     radiation therapy with or without trastuzumab in treating women who have breast cancer that     has spread to lymph nodes in the axilla (under the arm).   "
169970|NCT00054600|"     The purpose of this study is to determine whether Extracorporeal Photopheresis with UVADEX     (ECP) prior to bone marrow or peripheral blood stem cell transplantation is effective in the     prevention of Graft-versus-Host Disease (GvHD).   "
169971|NCT00054613|"     The purpose of this study is to determine whether extracorporeal photoimmune therapy with     UVADEX (ECP) added to standard therapy is effective in the treatment of chronic     graft-versus-host disease (GvHD).   "
169972|NCT00054626|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. It is not yet known if combination chemotherapy is effective in     preventing relapse in patients who have undergone radical cystectomy for bladder cancer.      PURPOSE: Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine     with that of observation in treating patients with bladder cancer who have undergone surgery     to remove the bladder.   "
169973|NCT00054639|"     The goal of this clinical research study is to learn if the combination of oblimersen sodium     and rituximab can help to shrink or slow the growth of the tumor in patients with B-cell     non-Hodgkin's lymphoma who have not responded to earlier treatment. Oblimersen Sodium is an     investigational drug. The safety of this combination treatment will also be studied   "
169974|NCT00054652|"     This study will collect information on (tricks) patients with focal dystonia use to relieve     their symptoms. Dystonia is a movement disorder caused by sustained muscle contractions often     causing twisting and abnormal posturing. Dystonia may be generalized, affecting at least one     leg and the trunk of the body, segmental, affecting adjacent body parts, or focal, affecting     a single body part, such as the hand or eyelid. It may be task-specific, such as writer's,     musician's or sportsman's cramps. Some patients with focal dystonia use (tricks), such as     touching the face or hand, to stop or alleviate the abnormal movement. This study will survey     the types of tricks people with focal dystonia use in order to learn more about the disorder.      Patients 18 years of age and older with focal dystonia may be eligible for this study.     Candidates will be screened for eligibility with a medical history, clinical evaluation, and     review of their medical records.      In one 30- to 45-minute clinic visit, participants will be interviewed about their dystonia     symptoms and the tricks they use to relieve the symptoms. They may be asked to show the     investigators how the tricks work   "
169975|NCT00054665|"     This study will examine the safety and effectiveness of an experimental drug called     Bortezomib (PS-341), given alone and in combination with a chemotherapy regimen called     Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin and Filgrastim (EPOCH), in     treating non-Hodgkin's B-cell lymphoma. In the laboratory, PS-341 kills lymphoma cells and     makes them more sensitive to chemotherapy. The EPOCH treatment regimen includes the drugs     doxorubicin, etoposide, vincristine, cyclophosphamide, prednisone, and filgrastim.      Patients 18 years of age and older with an aggressive non-Hodgkin's lymphoma that has     relapsed after treatment or is not responding to chemotherapy may be eligible for this study.     Candidates will be screened with a medical history and physical examination. Other tests that     may be required include blood and urine tests; lung function studies; imaging tests such as     magnetic resonance imaging, computed tomography and x-rays; and biopsy (surgical removal of a     small tissue sample) of tumor, bone marrow, or other tissue.      Upon entering the study, all participants will receive PS-341. The drug is given as a 3- to     5-second intravenous (through a vein) injection twice a week for 2 weeks. This is followed by     a 1-week rest. Each 3-week period comprises one treatment cycle. The number of cycles a     patient receives depends on how well he or she responds to the drug. Patients who do not have     a complete remission or whose tumor grows on this therapy will be offered PS-341 in     combination with up to six cycles of EPOCH chemotherapy. The treatment for patients taking     PS-341 plus EPOCH is as follows:        -  PS-341, given by 3- to 5-second intravenous (IV) injection on days 1 and 4 of each          cycle.        -  Doxorubicin, etoposide, and vincristine, given by continuous IV infusion over 4 days,          beginning on day 1 and ending on day 5 of each cycle. The drugs are delivered through a          lightweight portable infusion pump to an indwelling IV catheter (plastic tube) in a          vein.        -  Cyclophosphamide, given by IV infusion over 15 minutes on day 5 of each cycle.        -  Prednisone, given by mouth (pills) twice a day on days 1 through 5 of each cycle.        -  Filgrastim, given by injection under the skin starting on day 6 of each cycle and          continuing until the white blood cell count increases or until day 19 of the cycle.      Patients also take a combination of antibiotics 3 days a week during EPOCH to prevent     infection while resistance is lowered because of the chemotherapy. Etoposide, doxorubicin,     and cyclophosphamide doses are adjusted as needed, based on white blood cell counts of the     previous cycle. The first patients in the study will receive a low dose of PS-341. The dose     will be increased in subsequent small groups of patients as long as the preceding dose is     well tolerated.      Drug therapy for patients who are candidates for bone marrow transplant will be tailored to     permit transplantation. Patients who are not eligible for or who choose not to have a bone     marrow transplant will be followed at the National Institutes of Health (NIH) every 3 months     the first year, every 4 months the second year, every 6 months the third year, and then once     a year until their disease progresses or the study ends. Patients may have tumor and bone     marrow biopsies, blood draws, and computed tomography (CT) scans periodically to evaluate     disease status and drug side effects.   "
169976|NCT00054678|"     The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential     to add a new dimension to the management of post-infarct deterioration of cardiac function in     subjects with congestive heart failure. Based on pre-clinical studies, implantation of     autologous skeletal myoblasts may lead to replacement of non-functioning myocardial scar with     functioning muscle and improvement in myocardial performance. Preliminary data in human     subjects suggest skeletal myoblast implantation at the time of CABG may lead to the same     effects. In principal, myoblast implantation by catheter delivery may offer the same     therapeutic benefit. The present clinical study is to be conducted primarily to evaluate the     safety of MyoCell™ implantation using the MyoCath™ delivery system and secondarily to     evaluate the effect on regional myocardial function post treatment.   "
169977|NCT00054691|"     The goal of this clinical research study is to learn if the drug ZD1839 (Iressa) can shrink     or slow the growth of cancer in participants with recurrent and/or metastatic squamous cell     cancer (SCC) of the skin. The safety of this drug will also be studied.   "
170030|NCT00055432|"     This study hopes to evaluate whether the combination of Gemzar plus Alimta will have any     beneficial effects for patients with recurrent platinum-sensitive or platinum-resistant     ovarian or peritoneal cancer. Treatments are weekly for two weeks, with the 3rd week off and     will be repeated every 21 days. Side effects and the overall safety of the treatment will     also be monitored and evaluated. In addition, a Quality of Life questionnaire is part of this     study to help measure patient perceived benefits or drawbacks to this treatment regimen.   "
170031|NCT00055445|"     This study will measure the safety and tolerability of three different doses of IdB 1016 in     patients with hepatitis C disease who have not responded to or are poor candidates for     interferon-based therapies.      NOTE: THE STUDY WILL ONLY RECRUIT STUDY PARTICIPANTS AT UNIVERSITY OF WASHINGTON MEDICAL     CENTER IN SEATTLE   "
170032|NCT00055471|"     The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in     men with prostate cancer   "
169978|NCT00054704|"     This study examines if Riluzole, FDA approved for ALS, will improve symptoms of depression in     Bipolar Disorder.      Purpose: This study will examine the safety and effectiveness of riluzole (Rilutek trademark)     for short-term treatment of depression symptoms, such as depressed mood, psychomotor     retardation, and excessive sleeping in patients with bipolar disease. Riluzole is approved by     the Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis (ALS, also     known as Lou Gehrig's disease). Preliminary findings of a study using riluzole to treat acute     depression in patients with unipolar depression indicate that it may have antidepressant     properties in some patients.      Patients between 18 and 70 years of age with bipolar I or II disorder without psychosis may     be eligible for this 8-week study. Candidates must be currently depressed, must have had at     least one previous major depressive episode, and must have failed to improve with prior     treatment with at least one antidepressant. They will be screened with a medical history,     physical examination, electrocardiogram (EKG), blood and urine tests, and psychiatric     evaluation. A blood or urine sample will be analyzed for illegal drugs. Women of childbearing     potential will have a pregnancy test.      Participants will begin an 8-week course of treatment, starting with a placebo (a sugar pill     formulated to look like the active drug) and, at some point, switching to riluzole. In     addition to drug treatment, participants will undergo the following procedures:      Physical examination and electrocardiogram (EKG) at the beginning and end of the study;      Weekly check of vital signs (temperature, blood pressure and heart rate);      Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess     treatment response;      Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects.      At the end of the study, participants' psychiatric status will be reassessed and appropriate     long-term psychiatric treatment arranged.      Atendemos pacientes de habla hispana.      We enroll eligible participants locally and from around the country. Travel arrangements are     provided and costs covered by the National Institute of Mental Health (NIMH). (Arrangements     vary by distance and by specific study.) After completing the study participants receive     short-term follow-up care while transitioning back to a provider.   "
169980|NCT00054730|"     This study will investigate whether CX516 can improve attention, memory, language, or     behavior in adults with Fragile X Syndrome and/or Autism.      CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength. There is     evidence to suggest that the synapses in the brain of an individual with fragile X syndrome     are immature and abnormal. It is possible CX516 may partially correct this synaptic     transmission defect and lead to improvement in cognitive and behavioral functioning.      There is also reason to believe that these changes caused by CX516 could be helpful in     managing cognitive and behavioral symptoms in patients with autistic disorder.      Involvement for each participant will last 28 days. Participants will be given study     medication, a physical exam, and a variety of cognitive assessment tests to study potential     drug effectiveness at improving disease symptoms.   "
169981|NCT00054743|"     This study will determine whether blood levels of the anti-HIV medicine nevirapine are     different in HIV-infected patients in the United States from patients in Uganda. People from     all over the world take medications to treat HIV infection. These medicines work well in some     people but not in others, and they cause harmful side effects in some people and not in     others. These differences may be related to variations in how much of the drug reaches the     blood. Differences in drug blood levels among people in various areas of the world may be     attributed to differences in diet, state of health, ability to absorb the medicines from the     stomach, ability to eliminate the drugs from the body, and the brand of medicine taken. This     study will help scientists learn whether differences in blood levels of HIV medicines are     important in determining how well the drugs work in different patient populations.      HIV-infected patients 18 years of age and older in the United States and in Kampala, Uganda     who have been on an antiretroviral treatment regimen that includes at least 28 consecutive     days of nevirapine may be eligible for this study. Candidates will be screened with a medical     history, physical examination, and blood tests.      Participants will have a total of approximately about 5 ounces of blood drawn during this 6-     to 8-hour study. They will come to the NIH clinic in the morning, and a catheter (plastic     tube) will be inserted into an arm vein for collecting blood. (Alternatively, blood can be     collected by a needle inserted into an arm vein.) Blood will be withdrawn according to the     following schedule:        -  About 5 tablespoons will be collected upon arrival at the clinic after an overnight          fast. Within 30 minutes of this blood draw, the patient will have breakfast and take his          or her morning dose of nevirapine, along with any other medications that need to be          taken at that time.        -  1 tablespoon of blood will be drawn 2 hours after the nevirapine dose.        -  1 tablespoon of blood will be drawn 4 hours later (6 hours after the nevirapine dose).      The blood will be analyzed for levels of nevirapine and possibly other HIV medicines. Some of     the blood will be stored for later analysis of genes (cytochrome P450 and MDR1) that are     involved in eliminating medicines from the body.   "
169982|NCT00054756|"     This study will determine the safety and activity of a new formulation of     thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with     certain thyroid gland abnormalities. Normal thyroid gland function depends on proper chemical     signaling between the thyroid gland, the hypothalamus (the part of the brain where TRH is     made), and the pituitary (another part of the brain). The TRH test helps assess this     interaction. Production of the only FDA-approved preparation of TRH was stopped in July 2002.     As a result, to have a continuous source of TRH available for NIH clinical and research     purposes, the NIH Clinical Center (CC) Pharmacy Department produced a pharmaceutical grade     formulation of TRH for patient use. This study will test the CC formulation in healthy     volunteers to show that its activity and side effects are similar to those of the previously     available commercial test preparation. It will then be studied in CC patients for whom the     diagnostic test is recommended.      Healthy volunteers between 18 and 65 years of age and all patients requiring TRH evaluation     of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study. Patients     include those with pituitary reserve, inconsistent thyroid function test, inappropriate TSH     secretion, or pre- and post-operative evaluation of pituitary tumors. Normal volunteers will     be screened with a medical history, physical examination, and blood tests. Women of     child-bearing potential will be given a pregnancy test; pregnant and breast-feeding women may     not participate.      The TRH test procedure will be the same for healthy volunteers and patients. All participants     fast from midnight before the morning of the test. In the morning, a catheter (flexible     plastic tube) is inserted into an arm vein for easy injection of the TRH and collection of     blood samples. Blood pressure is monitored before and during the test. A blood sample is     drawn, and then TRH is given through the catheter over a 1-minute period. Another nine blood     samples are collected over a 3-hour period from the time of the TRH injection for measuring     levels of various hormones. A total of less than 4 tablespoons of blood is taken for the     test.   "
169983|NCT00054769|"     Tuberculosis is a major cause of mortality among AIDS patients in the developing world. The     diagnosis of tuberculosis in HIV infected children is complicated by inefficient and     expensive tuberculosis tests and vague diagnostic criteria. This study will evaluate the     accuracy and efficiency of several different tuberculosis tests that could be used in     developing countries.   "
169984|NCT00054795|"     The primary purpose of the study is to determine if patients with brain metastases from     non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation     therapy retain their neurologic function and ability to think for a longer time compared to     patients treated with whole brain radiation therapy alone.   "
169985|NCT00054808|"     Eligible patients will have low- or intermediate-grade Non-Hodgkin's Lymphoma (NHL) that has     progressed after standard chemotherapy. Patients will receive gallium nitrate 300 mg/m2/day     by continuous IV infusion for 7 consecutive days using a portable infusion pump.     Hospitalization is not required. Stable or responding patients will receive additional     gallium nitrate infusions every 3 weeks until the time of disease progression, for a maximum     total of 8 infusions, or 2 cycles after complete remission has been documented.   "
170033|NCT00055484|"     The purpose of this study is to determine if zonisamide is effective as a preventative     medication for individuals with migraine headache.   "
170254|NCT00066027|"     The primary purpose of this clinical trial is to determine whether low-dose doxycycline can     reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and     not on hormone replacement therapy (i.e., estrogen deficient).   "
169986|NCT00054821|"     Joint injury and trauma dramatically increase the risk of developing osteoarthritis (OA). The     purpose of this study is to determine what factors lead to decreased pain, improved joint     function, and repair of the joint surface in post-traumatic OA.      Study hypotheses: 1) Ankle motion during distraction will result in clinically significant     improvements in Ankle Osteoarthritis Scale scores, SF-36 scores, and improved cartilage     thickness distribution over the habitually most heavily loaded portion of the articular     surface, as compared to the use of distraction without ankle motion. 2a) Ankles with low     geometric surface irregularity and greater range of motion will have better preservation of     neo-chondroid tissue (increased normalized cartilage thickness and reduced longitudinal     compressive strain in the habitually heavily regions of the articular surface) than those     with high surface irregularity. 2b) Low geometric surface irregularity and greater range of     motion will have reduced habitual focal or regional contact stress elevation. 3) Joints that     have better improvements in Ankle Osteoarthritis Scale scores and improved cartilage     thickness distribution over habitually heavily loaded portion of the articular surface will     have improved normalization of synovial fluid markers of biosynthetic/degradative activity     and oxidative stress.   "
169987|NCT00054834|"     The purpose of this trial is to determine the safety of 90Y-hLL2 at different dose levels in     the treatment of Non-Hodgkin's lymphoma.   "
172408|NCT00089674|"     This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing     Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.   "
169989|NCT00054860|"     The purpose of this study is to test the safety of an HIV DNA vaccine (EP HIV-1090) and to     test whether or not the vaccine can stimulate immune system responses in HIV uninfected     people. This vaccine uses only parts of the virus's DNA and cannot cause HIV infection.   "
169990|NCT00054873|"     The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given     alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal     or gastric adenocarcinoma.   "
169991|NCT00054886|"     The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a     treatment for metastatic kidney cancer.   "
169992|NCT00054899|"     EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is     designed to activate the immune system to develop a response against tumor cells in order to     delay or prevent the recurrence of cancer. This study will test the safety and measure the     level of immune stimulating capability of EP2101 in patients with Non-Small Cell Lung Cancer.   "
169993|NCT00054912|"     EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is     designed to activate the immune system to develop a response against tumor cells in order to     delay or prevent the recurrence of cancer. This study will test the safety and measure the     level of immune stimulating capability of EP2101 in patients with Colon Cancer.   "
169994|NCT00054925|"     To determine the effectiveness of continuous patient contact on weight loss maintenance.   "
169995|NCT00054938|"     The purpose of this study is to find the best way to prevent heart disease and stroke in     people with lupus (systemic lupus erythematosis, or SLE). The study will evaluate the     effectiveness of medication and a phone-based education program in controlling four risk     factors for heart disease: smoking, obesity, high blood pressure, and inactivity. The study     will also test the safety of commonly used heart medications in people with lupus.   "
169996|NCT00054951|"     MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to “stick,” to     magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is     added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and     deposited in the area of a tumor, where it is thought that it then “leaks” through the blood     vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes “free     from” the magnetic beads and will then be able to act against the tumor cells. The iron     component of the particle has magnetic properties making it possible to direct MTC-DOX to     specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that     MTC-DOX used with the magnet may target the chemotherapy directly to liver tumors and provide     a treatment to patients with liver cancer.      Patients enrolled in the study will be administered MTC-DOX through a hepatic artery catheter     inserted under radiological guidance. During and following injection of the MTC-DOX, the drug     will be localized to the hepatic tumor site by use of an external magnet. Dose may be divided     in order to localize MTC-DOX to all lesions. The MTC-DOX intrahepatic infusions will be     repeated every three weeks until tumor progression, complete remission, unacceptable     toxicity, or a maximum of six treatment cycles.      The purpose of this Phase 1/2 study is to evaluate time to disease progression following     administration of MTC-DOX.   "
169997|NCT00054964|"     This study was designed to examine the effectiveness of a breath-operated albuterol inhaler     in asthma patients who have difficulty using their standard press-and-breathe inhaler.   "
169998|NCT00054977|"     This is a Phase I, multi-center study of GM-CT-01, which has been shown to increase the     anti-tumor activity of 5-fluorouracil in mice. The primary reason for doing the study is to     determine the safety of GM-CT-01 given alone and in combination with therapeutical dosage of     5-Fluorouracil, in patients who have advanced cancer that can be measured by CT scan.   "
170034|NCT00055497|"     The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of     clinical remission up to 56 weeks in participants with Crohn's disease who participated in     NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with     Crohn's disease up to 56 weeks.   "
170035|NCT00055510|"     This research study is intended to evaluate the safety and effectiveness of 3 different doses     of BO-653, an investigational inhibitor of LDL cholesterol oxidation, when given orally twice     a day compared to placebo (an inactive substance) in preventing restenosis (closure of     vessel) within six months after stent implantation. Patients must be enrolled into this study     within 24 hours after the stenting procedure.      Additionally, over a 1- to 9-month post-stent period, the study will compare the safety and     effectiveness of BO-653 versus placebo for measures of coronary artery vessel size by     quantitative coronary angiography, major adverse cardiac events, and effects on the oxidative     status of plasma lipids and other plasma components.   "
169999|NCT00054990|"     This study will evaluate the usefulness of transcranial magnetic stimulation (TMS) in     measuring cortical excitability. The cortex is the outer part of the brain. Patients with     seizures have increased cortical excitability and are often treated with antiepileptic drugs     to reduce this excitability. The therapeutic effects of antiepileptic drugs are usually     tracked with blood tests that measure their blood levels. However, these blood tests may not     always correctly reflect the effects of the drugs on the brain.      TMS has been used successfully to measure cortical excitability in many neurological     diseases, including epilepsy, and may be helpful in measuring drug effects on the brain     directly. For this procedure, a wire coil is held over the scalp. A brief electrical current     is passed through the coil, creating a magnetic pulse that stimulates the brain. This may     cause a pulling sensation on the skin under the coil and twitching in muscles of the face,     arm, or leg. During the stimulation, the participant may be asked to tense certain muscles     slightly or perform other simple actions.      Healthy normal volunteers between 18 and 55 years of age may be eligible for this study.     Candidates will be screened with a medical history, physical and neurological examination,     electroencephalogram (EEG), and blood tests.      On the first day of the study, participants will have a baseline TMS and will be randomly     assigned to take one of two antiepileptic drugs: group A will take the carbamazepine; group B     will take lamotrigine. If they wish, participants may be admitted to the NIH Clinical Center     for the first 5 days of drug administration while the proper dosage is being determined. They     will then be discharged and continue taking the drug for a total of 36 days. During this     time, they will have daily blood tests and TMS from days 2 through 5, and again on days 12     and 36. Group A will have additional blood sampling and TMS on days 37, 39, 44, and 53; Group     B will have blood tests and TMS on days 38, 40, 45, and 53.   "
170053|NCT00055770|"     Phase I/II trial to study the effectiveness of combining erlotinib with docetaxel in treating     patients who have locally advanced, recurrent, or metastatic head and neck cancer. Erlotinib     may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs     used in chemotherapy work in different ways to stop tumor cells from dividing so they stop     growing or die. Combining erlotinib with docetaxel may kill more tumor cells.   "
172409|NCT00089687|"     The purpose of this study is to assess GBR 12909 in cocaine experienced African American     Volunteers.   "
170000|NCT00055003|"     The purpose of this study is to use brain imaging technology to examine the effect of the     hormone hydrocortisone on the brain's response to various facial expressions.      Glucocorticoids can influence emotional behavior and cognition; when given long-term, the     hormones may lead to mania or depression. One way glucocorticoids may influence emotional     behavior is by affecting the activity of certain parts of the brain that participate in     emotional processing. Brain imaging studies indicate that the amygdala, ventral medial     prefrontal, and other prefrontal cortical areas of the brain are activated during tasks that     require processing of emotional stimuli. These brain structures contain dense concentrations     of glucocorticoid receptors. This study will use functional magnetic resonance imaging (fMRI)     to study the brain activity of participants as they view faces that express different     emotions. Participants will perform this task under a dose of either the glucocorticoid     hydrocortisone or placebo (an inactive solution).      Participants in this study will be screened with a medical history, physical examination,     blood tests, and an interview about their mood, degree of nervousness, and behavior. On Visit     1, participants will undergo screening and neuropsychological testing. For 3 days prior to     Visit 2, participants will collect their saliva. During Visit 2, participants will undergo     MRI scans of the brain after infusion with either a high or low dose of hydrocortisone or     placebo. Participants will also undergo functional MRI (fMRI). Blood samples will be     collected every 15 minutes during the scan. Following the MRI, participants will take     attention and memory tests.   "
170001|NCT00055016|"     The purpose of this study is to compile a registry of patients with Fabry disease, an     inherited metabolic disorder. In this disease, an enzyme called a-galactosidase A, which     normally breaks down a lipid (fatty substance) called globotriaosylceramide (Gb3), is missing     or does not function properly. As a result, Gb3 accumulates, causing problems with the     kidneys, heart, nerves, and blood vessels. It is not known exactly how lipid accumulation     causes these problems, but in another lipid storage disease called Gaucher disease the     illness can be reversed if the accumulated lipid is removed by repeated intravenous (into a     vein) infusions of the deficient enzyme.      The Fabry disease registry is a voluntary and anonymous list of patients that includes     information about their health and allows doctors to follow changes in their symptoms and     test results over time. It also allows doctors to compare symptoms between patients who are     receiving certain therapies with those who are not receiving therapy. The goals of the     registry are to:        -  Better understand the natural history of Fabry disease, including disease variations          within and between affected families;        -  Provide a basis for developing guidelines for disease management;        -  Evaluate how treatment affects the course of disease;        -  Provide high-quality data and analyses that will help to continuously develop better          treatments.      Patients of all ages with biochemical or genetic evidence of Fabry disease (i.e., individuals     who have a deficiency of the enzyme a-galactosidase A or a mutation in the gene that encodes     this enzyme, or both) are eligible for this study. This worldwide study will include 100     patients participating in Fabry disease studies at the NIH. These patients will come to the     NIH Clinical Center only as required for participation their Fabry disease study. No     additional procedures will be required for the current registry study.      NIH patients will take part in the registry study for their lifetime, or as long as they are     being followed at the NIH for their Fabry disease. At their regularly scheduled NIH clinic     visits, participants will have routine medical procedures and examinations deemed necessary     by the doctor. The results of blood and urine tests taken at these visits will be entered     into the registry database. Blood tests will include information on genotype (determination     of which gene mutation is responsible for the disease), a-galactosidase A levels, Gb3 levels,     and creatinine. Urine tests results will include creatinine clearance (a measure of kidney     function) and protein evaluation.   "
170002|NCT00055029|"     This study will explore the causes and eye problems of X-linked juvenile retinoschisis     (XLRS), an inherited disease that causes vision loss primarily in young males. The vision     loss, which worsens over time, is a result of schisis, or splitting, of the layers of the     retina (tissue that lines the back of the eye). A better understanding of why and how XLRS     develops might lead to improved treatments.      Patients 9 months of age and older with XLRS and females who are suspected carriers of the     gene responsible for the disease (such as the mother of the patient) may be eligible for this     study. Other family members of patients also may be enrolled.      Patients will undergo the following tests and procedures:        -  Personal and family medical history to review past and current medical conditions and          treatments, particularly regarding eye disease, and to construct a family tree.        -  Eye examination to assess visual acuity (eye chart test) and examine pupils, lens,          retina, and eye movements. The pupils will be dilated with drops for this examination.        -  Photography of the retina to help evaluate the status of the retina.        -  Specialized eye tests to evaluate color vision, field of vision, and ability to see in          the dark.        -  Electroretinogram (ERG) to examine what happens to the eyes after a flash of bright          light. For this test, the patient sits in a dark room for 30 minutes with his or her          eyes patched. Then, a small silver disk electrode is taped to the forehead, the eye          patches are removed, the surface of the eye is numbed with eye drops and contact lenses          are placed on the eyes. The patient looks inside a large empty bowl and then a light          flashes, first in the dark and then with a light turned on inside the bowl. The contact          lenses sense small electrical signals generated by the retina when the light flashes.        -  Blood test to examine DNA for genetic study of XLRS.      Family members will provide a blood sample for genetic study.   "
170003|NCT00055042|"     This study will compare the side effects of two laser treatments for diabetic macular edema,     a common condition in patients with diabetes. In macular edema, blood vessels in the retina-a     thin layer of tissue that lines the back of the eye-become leaky and the retina swells. The     macula-the center part of the retina that is responsible for fine vision-may also swell and     cause vision loss. Traditional laser treatment (argon blue or green, or yellow) for macular     swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision.     A different type of laser (diode) may have less damaging effects to the eye and fewer     long-term adverse effects, but this is not known. The results of this study on side effects     of the treatments will be used to design a larger study of effectiveness. The study will also     examine whether vitamin E can reduce the damage caused by laser treatment. Patients with     elevated cholesterol levels will be invited to participate in a cholesterol reduction part of     the study to compare normal-pace cholesterol reduction with accelerated reduction.      Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema may be     eligible for this study. Candidates will be screened with the following tests and procedures:        -  Medical history and physical examination.        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to          examine pupils, lens, retina and eye movements. The pupils will be dilated with drops          for this examination.        -  Blood tests to measure cholesterol and vitamin E blood levels, blood clotting time,          hemoglobin A1C (a measure of diabetes control), and to evaluate liver and kidney          function.        -  Eye photography to help evaluate the status of the retina and changes that may occur in          the future. Special photographs of the inside of the eye are taken using a camera that          flashes a bright light into the eye.        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina          are taken using a camera that flashes a blue light into the eye. The pictures show if          any dye has leaked from the vessels into the retina, indicating possible blood vessel          abnormality.        -  Multifocal electroretinogram to measure electrical responses generated within the          retina. The test, which takes about 1-1/2 hours, is painless.      Participants will be randomly assigned to take 1600 IU of vitamin E or placebo (an inactive,     look-alike pill) daily. After taking the pills for 3 months or more, patients who require     laser treatment will be randomly assigned to one of the two laser therapies. (Patients with     macular edema in both eyes will receive both treatments, one in each eye.) For these     procedures, eye drops are put in the eye to numb the surface and a contact lens is placed on     the eye during the laser beam application. Several visits may be required for additional     laser treatments. The maximum number of treatments depends on how well they are working.     Patients will return for follow-up visits 1, 3, and 6 months after the first treatment, and     then every 6 months until either the patient returns for a 3-year visit; the last enrolled     patient returns for the 1-year visit; or the patient requests to leave the study. During the     follow-up visits, patients' response to treatment will be evaluated with repeat tests of     several of the screening exams.   "
170036|NCT00055523|"     Purpose of the study is to test whether adalimumab can induce clinical remission in subjects     with active Crohn's disease when compared to placebo (an inactive substance)   "
170037|NCT00055536|"     The purpose of this study is to determine the safety, tolerability, and efficacy of     natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission     (CDAI greater than/equal to 150) and are currently taking Remicade. It is thought that     natalizumab may stop the movement of certain cells, known as white blood cells, into bowel     tissue. These cells are thought to cause damage in the bowel leading to the symptoms of     Crohn's disease.      Patients who complete this study may be eligible for long-term natalizumab therapy via     extension protocol ELN100226-351.   "
170190|NCT00065143|"     The goal of this clinical research study is to learn if clofarabine, when given in     combination with ara-C (cytarabine), can help to improve the disease's response to therapy     and to increase the duration of response in patients who are 50 years or older with leukemia.     The safety of this combination treatment will also be studied.   "
170051|NCT00055731|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as     nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from     producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from     dividing so they stop growing or die. It is not yet known whether hormone therapy is more     effective with or without chemotherapy in treating prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or     without docetaxel and estramustine in treating patients who have prostate cancer that is     locally advanced or at high risk of relapse.   "
170052|NCT00055757|"     Phase II trial to study the effectiveness of combining tipifarnib with gemcitabine and     cisplatin in treating patients who have stage III or stage IV non-small cell lung cancer.     Drugs used in chemotherapy such as gemcitabine and cisplatin use different ways to stop tumor     cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor     cells by blocking the enzymes necessary for tumor cell growth. Combining tipifarnib with     combination chemotherapy may kill more tumor cells.   "
172637|NCT00102843|"     The purpose of this study is to determine whether lowering of fasting homocysteine     concentrations improves vascular function in healthy volunteers, irrespective of the     homocysteine-lowering agent.   "
170004|NCT00055055|"     This study will examine families in which one sibling of a sibling pair, or twin pair, has     developed a systemic rheumatic disease and one has not, to see if and how the two differ in     the following:        -  Blood cell metabolism;        -  Types of cells in the blood;        -  Environmental exposures or genetic factors that might explain why one developed disease          and the other did not.      Families in which one sibling has developed a systemic rheumatic disease, rheumatoid     arthritis, systemic lupus erythematosus, scleroderma, dermatomyositis, or myositis, and the     other has not, are eligible for this study. The siblings may or may not be twins, but must be     of the same gender and be within a 5-year age difference. Biological parents, or, in some     cases, children, will also be included in the study. Normal, healthy volunteers will serve as     control subjects.      Participants will undergo some or all of the following tests and procedures:        -  Medical history and physical examination. Participants will also be asked permission to          obtain medical records for review.        -  Questionnaires about environmental exposures at work, at home, and elsewhere. Probands          (participants with rheumatic disease) and their healthy siblings will also answer          questions about infections, vaccinations, medications or dietary supplements, sun          exposure, and stressful events during the year before disease diagnosis in the affected          sibling.        -  Blood and urine collection for the following tests:        -  Routine blood chemistries and other studies to rule out certain diseases or medical          problems;        -  Evidence of past toxic exposures and certain infections;        -  Presence of cells from the mother in the child s blood and vice versa. (Recent studies          suggest that during pregnancy or delivery, cells from the mother and baby may be          exchanged and circulate in the body for many years, possibly causing problems);        -  In twin or sibling pairs, presence of certain genes that may be more common in patients          with systematic rheumatic diseases as compared with their unaffected siblings and normal          volunteers;        -  In identical twins, comparison of their blood cell metabolism to see if and how the          metabolism differs in people with rheumatic disease.      Participants may be asked for permission to have some of their blood and urine samples stored     and to obtain previously collected blood or tissue biopsy specimens that are no longer needed     for clinical care, for research purposes. They may also be asked to give additional blood or     urine samples.      Participants will be followed every year for 5 years (either in person or by questionnaire)     to evaluate any changes in their condition. The final 5-year evaluation will repeat some of     the questionnaires and procedures described above.   "
170005|NCT00055068|"     This study will evaluate a treatment program for young children with Obsessive Compulsive     Disorder (OCD) and their families.   "
170006|NCT00055081|"     The purpose of this study is to examine how services and housing provided for homeless     families affect the mental health and behavior of homeless children over time.   "
170007|NCT00055094|"     While most people with HIV experience significant destruction of their immune systems, some     people appear to have preserved immune function and can control the virus without drugs.     Early treatment with anti-HIV drugs may help preserve the immune system, allowing it to     control the virus once the drugs are stopped. This study will evaluate the immune system     response of HIV infected people who are treated with anti-HIV drugs soon after being     infected.   "
170008|NCT00055107|"     Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a     significant problem for HIV infected children in developing countries. C. parvum infection     can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV     infected children. The purpose of this study is to test the safety of NTZ in HIV infected     children who have chronic diarrhea caused by C. parvum.      Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants,     children, and adolescents with chronic diarrhea caused by C. parvum infection.   "
170009|NCT00055120|"     The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV     infected patients who are being treated for opportunistic infections (OIs). This study will     follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with     an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from     the OI.   "
170010|NCT00055133|"     Paxceed™ is being developed by Angiotech Pharmaceuticals, Inc. for the treatment of     Rheumatoid Arthritis (RA). The main objective of this study is to determine the effectiveness     of treatment with Paxceed™ in patients with RA. In RA, there is an increase in cell growth     and changes in cell function. The active substance in Paxceed™, paclitaxel, has undergone     clinical studies as a cancer chemotherapeutic agent and has demonstrated its usefulness as an     agent that stops growth of cells and blocks certain types of cell function associated with     RA. Because of these effects, it is thought that Paxceed™ might alter the destructive course     of RA.   "
170011|NCT00055146|"     The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously     treated patients with chronic lymphocytic leukemia (CLL)   "
170012|NCT00055159|"     This study will test the effectiveness of low-dose recombinant tissue plasminogen activator     (rtPA, or alteplase) in dissolving blood clots in major arm or neck veins. rtPA is given to     patients with heart attacks to dissolve blood clots in blocked coronary arteries. Blood clots     that develop in major arm or neck veins usually develop after a venous access device (VAD) or     catheter has been placed in the vein. The clot often causes arm, shoulder or neck swelling     and pressure or discomfort. Current treatments include removing the VAD, using blood thinners     such as heparin and warfarin, or using rtPA to dissolve the clot. All these options have     disadvantages, however, including the risk of abnormal bleeding. This study will evaluate     whether lower doses of rtPA can effectively dissolve clots without requiring an extended     hospital stay, as is needed with the current higher-dose regimen.      Patients 18 years of age and older who are enrolled in or are being evaluated for a Clinical     Center study and who have a blocked jugular, axillary, subclavian, or brachiocephalic vein     may be eligible for this study. The blockage may or may not be associated with use of a VAD.      Participants will have one or two treatments with a low dose of rtPA, followed by a blood     thinner taken by mouth or by injection for 5 to 7 weeks. On the first treatment day, the     patient has a venogram, in which a catheter is placed in an arm vein and passed up to and     through the blood clot that is blocking the blood flow in the vein. This is done under an     x-ray machine so the radiologist can see exactly where the tube is going. Then, rtPA is     injected into the clot about every 30 seconds for 15 to 30 minutes. The catheter is kept in     place to maintain access to the vein for additional treatment the next day, if needed. The     patient then begins treatment with heparin, either as an outpatient or an inpatient. A second     venogram is done the next day. If the venogram shows that the vein is open, anti-clotting     treatment with heparin or warfarin continues. If the venogram shows that the vein is still     blocked, the rtPA treatment is repeated while the blood thinner treatment continues. The     patient has a third venogram the following day. If the vein has opened, heparin and warfarin     treatment continues. If the vein is still blocked, the patient's participation in the study     ends. Although the patient is no longer formally in the study, he or she may choose to     receive additional treatments with rtPA in higher doses at NIH or to continue using blood     thinners under the direction of the primary physician.      Blood tests are done during blood thinning therapy to monitor and adjust the dosage.     Additional blood samples are taken before and at timed intervals after each rtPA treatment to     measure the response to therapy. Patients who benefit from rtPA treatment remain on blood     thinners for 5 to 7 weeks and then return to NIH for a follow-up venogram to see if the vein     is still open. During warfarin therapy, blood tests are done every few days during the first     week or two and every 2 weeks thereafter to ensure the optimal drug dose is being     administered. If the repeat venogram at 5 to 7 weeks shows that the vein has closed, the     blood thinners (warfarin or heparin) will be stopped and the patient's participation in this     study will end. If the vein has remained open, the patient's doctor will decide whether or     not to continue anti-clotting therapy.   "
170013|NCT00055172|"     This study will examine the role of hereditary factors in different forms of severe combined     immunodeficiency (SCID).      Patients with immunodeficiencies may be eligible for this study. Candidates include:        -  Patients with diminished numbers of T cells or NK cells or both, or        -  Patients with normal T cell and NK cell numbers but diminished T cell, B cell, or NK          cell function.      Relatives of patients will also be studied.      Participants will have blood samples collected for genetic analysis in studies related to     SCID at the National Institutes of Health and other institutions.   "
170014|NCT00055185|"     The purpose of this study is to determine any adverse effects of PRO 542 after administration     and to determine the anti-HIV effects of PRO 542 in the patient.   "
170015|NCT00055198|"     The purpose of this study is to provide daptomycin, an antibiotic, to patients who are     failing conventional therapy, or who cannot take approved antibiotics for one reason or     another.   "
170016|NCT00055224|"     Fear and anxiety are normal responses to a threat. However, anxiety is considered abnormal     when the response to the threat is excessive or inappropriate. This study will examine     changes in the body and brain that occur during unpleasant learning experiences in healthy     volunteers with high, moderate, and low levels of anxiety.      A high degree of generalized anxiety is a component of many anxiety disorders and is regarded     as a marker of vulnerability for these disorders. People with anxiety disorders and     individuals with high degrees of anxiety have inappropriate expectations of unpleasant     events. This study will investigate the development of expecting unpleasant events in healthy     volunteers with varying degrees of anxiety using aversive conditioning models. A later phase     of the study will enroll participants with anxiety disorders and compare their responses to     those of healthy volunteers.      Patients who meet criteria for an anxiety disorder, and healthy volunteers who have no     history of psychiatric or major medical illness will be enrolled in this study. Volunteers     will come to the NIH Clinical Center three times for outpatient testing.   "
170087|NCT00063258|"     The goal of this clinical research study is to learn about the safety and effectiveness of     OSI-774 when combined with standard chemotherapy (carboplatin and paclitaxel) before surgery     in the treatment of non-small cell lung cancer.   "
170088|NCT00063726|"     The purpose of this study is to allow patients to receive VELCADE™ (bortezomib) for Injection     who experienced progressive disease(PD) while receiving high-dose dexamethasone from the     M34101-039 study.   "
170017|NCT00055237|"     This study will examine the safety and effectiveness of the experimental drug bevacizumab for     treating both non-acquired immune deficiency syndrome (AIDS) and AIDS-associated Kaposi's     sarcoma (KS). KS tumors depend on the formation of new blood vessels for their growth.     Bevacizumab is an antibody to a protein called vascular endothelial growth factor (VEGF) that     is produced by the body and is involved in blood vessel growth. Bevacizumab may block the     action of VEGF, and thus help shrink KS lesions.      Patients 18 years of age and older with Kaposi's sarcoma that is restricted to the skin and     is not life threatening may be eligible for this study. Candidates will be screened with a     medical history and physical examination, blood and urine tests, electrocardiogram (EKG),     chest x-ray, and, if needed, imaging studies to evaluate internal tumors.      Participants will receive bevacizumab intravenously (by vein) once a week for 2 weeks and     then every 3 weeks at the National Institutes of Health (NIH) Clinical Center. The first     infusion takes about 90 minutes, the second takes about 60 minutes, and subsequent infusions     take about 30 minutes. Infusions may take longer, however, if the drug is better tolerated at     a slower infusion rate. Patients will be evaluated with the following tests and procedures:        -  Physical examination, assessment of drug side effects, measurement of KS lesions, and          photographs of lesions once a week for the first 6 weeks of therapy, and then every 3          weeks.        -  cluster of differentiation 4 (CD4) cell counts and human immunodeficiency virus (HIV)          viral load in HIV-positive patients every 12 weeks.        -  Biopsies of lesions: upon entering the study, at week 12, and at the time of a response          of the tumor to therapy or at the end of treatment, if treatment ends at week 18 or          later.        -  Additional biopsies, if requested. (Additional biopsies are not required.)        -  Other procedures, such as computed tomography (CT) or magnetic resonance imaging (MRI)          scans, if medically indicated.      Patients may continue bevacizumab therapy indefinitely if they are benefiting from it, as     long as they have no substantial toxicity or other conditions that would cause them to stop     receiving it and the protocol remains open.   "
170018|NCT00055250|"     The purpose of this study is to determine the effectiveness and side effects of LY293111     given in combination with gemcitabine in patients with pancreatic cancer.   "
170019|NCT00055263|"     The purposes of this study are to:        -  Test the safety of DN-101 in patients with advanced malignancies        -  Understand how fast the body absorbs, processes, and eliminates DN-101        -  Determine the highest dose of DN-101 that is well tolerated by cancer patients        -  Learn how fast the body absorbs, processes, and eliminates DN-101 compared to the          approved product   "
170020|NCT00055289|"     This study will use transcranial magnetic stimulation (TMS) to investigate functions of brain     regions that may use information from sensory organs, such as the eyes or ears, to generate     movements.      For TMS, a wire coil is held over the scalp. A brief electrical current is passed through the     coil, creating a magnetic pulse that stimulates the brain. This may cause a pulling sensation     on the skin under the coil and twitching in muscles of the face, arm, or leg. During the     stimulation, the participant may be asked to tense certain muscles slightly or perform other     simple actions.      Healthy normal volunteers 18 years of age and older may be eligible for this study.     Individuals with a history of neuropsychiatric disorders, brain lesions such as tumors,     stroke, or trauma, or a history of significant medical disorders, such as cancer, may not     participate. Candidates will be screened with a medical history, brief physical examination,     and questionnaire.      Participants will be presented a sequence of shapes (circles, rectangles, and triangle) and     will count the number of a specified shape. Each number is assigned to a corresponding     response button. The subject will push the appropriate button with the corresponding finger.     During these experiments, the scalp will be stimulated by TMS. Each set of TMS measurements     will take up to 3-1/2 hours.   "
170021|NCT00055302|"     The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1     mg given once daily in subjects with McCune-Albright Syndrome.   "
170022|NCT00055315|"     This study will expose patients to either a Systems Training for Emotional Predictability and     Problem Solving (STEPPS) or treatment as usual (TAU) to determine the more effective therapy     for treating borderline personality disorder.   "
170023|NCT00055328|"     This study will compare a brief form of counseling to usual care for the treatment of minor     depression in the primary care setting.   "
170024|NCT00055341|"     Pegylated interferon (PEG-interferon) and ribavirin are accepted treatments for hepatitis C     virus (HCV) infection. However, HCV infection progresses differently in patients who are     coinfected with HIV and in hemophiliacs. This study will evaluate the effectiveness of     PEG-interferon and ribavirin for treating HCV in HIV infected hemophiliacs.   "
170025|NCT00055354|"     The purpose of this study is to evaluate acupuncture as a treatment for Post-Traumatic Stress     Disorder (PTSD) and to correlate the diagnosis of PTSD with Traditional Chinese Medicine     (TCM) diagnostic patterns.   "
170026|NCT00055367|"     The purpose of this study is to determine the safety and tolerability of natalizumab in     adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD).     It is thought that natalizumab may stop the movement of certain cells, known as white blood     cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the     symptoms of Crohn's disease.      Patients who complete this study may be eligible for long-term natalizumab therapy via     extension protocol ELN100226-352.   "
170027|NCT00055380|"     This study will examine the effects of certain investigational anti-cancer drugs on the     genetic and protein makeup of cells. The findings will be entered into a database that may be     used to: 1) determine the optimal dose of drug that will provide the most benefit with the     least harmful side effects; and 2) predict which patients will have a greater chance of     developing side effects or a greater chance of benefiting from the drug.      Patients 18 years of age and older who are receiving the anti-cancer drugs flavopiridol or     perifosine in an NIH clinical trial may be eligible for this study.      Participants will undergo the following procedures both before starting treatment and during     the first treatment cycle to look for genetic or chemical changes produced in response to the     study drug:        -  Blood draws.        -  Buccal cell brushings: Collection of buccal cells (cells lining the inside of the          cheeks) from the inside of the cheeks using a soft bristle brush for a few seconds          several times. The patient then rinses the mouth with salt water for 1 minute and then          spits into a cup.        -  Buccal cell biopsies (on both sides of the mouth): For this procedure, a local          anesthetic is given to numb the biopsy area. Then, a small piece of tissue from the          inner lining of the mouth is removed with a small sharp cookie-cutter instrument. The          biopsy findings will be compared with those of the cheek brushings to see if the          information is similar.        -  Tumor biopsies: In patients whose tumor is easily accessible, such as the skin abdominal          fluid, tissue biopsies will be requested. Depending on the type and location of the          tumor, the biopsy may be done with a forceps, a large needle (needle biopsy), a          cookie-cutter instrument (punch biopsy), or a small knife (excisional biopsy). All of          these procedures are done with a local anesthetic.   "
170028|NCT00055393|"     This study will determine whether the drug bupropion is an effective treatment for     Pathological Gambling.   "
170029|NCT00055419|"     The purpose of this clinical research study is to learn about the safety of cetuximab in     patients with stage IV colorectal cancer, and who may benefit from cetuximab.   "
170089|NCT00063752|"     The purpose of this study is to determine if the use of PI-0824 in patients with Pemphigus     vulgaris is safe.   "
179018|NCT00189748|"     To assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who     are eligible for the administration after 100 days post transplant (up to 1 year)   "
170038|NCT00055549|"     This study will examine how dextromethorphan, a drug that alters reflexes of the larynx     (voice box), might change voice symptoms in people with voice disorders due to uncontrolled     laryngeal muscle spasms. These include abductor spasmodic dysphonia (breathy voice breaks),     adductor spasmodic dysphonia (vowel breaks), muscular tension dysphonia (tight strained     voice), and vocal tremor (tremulous voice). Dextromethorphan-one of a group of drugs called     NMDA antagonists-has been used for years in over-the-counter cough suppressant medicines. In     animal studies, the drug has blocked one of the reflexes in the larynx that may be associated     with spasms in the laryngeal muscles. This study will compare the effects of     dextromethorphan, lorazepam (a valium-type drug), and a placebo (inactive substance) in     patients with the four types of voice disorders described above.      Patients with spasmodic dysphonia, muscular tension dysphonia and vocal tremor may be     eligible for this study. Individuals who smoke or use tobacco, who have vocal nodules or     polyps, or who have a history of airway obstruction may not participate. Candidates will be     screened with a medical history and physical examination, a questionnaire, voice recording     (repeating sentences into a microphone), and nasolaryngoscopy (examination of the larynx with     a tube advanced through the nose). For the nasolaryngoscopy, the inside of the nose is     sprayed with a decongestant (to open the nasal passages) and possibly a local anesthetic. A     small, flexible tube called a nasolaryngoscope is passed through the nose to look at the     larynx during speech and other tasks, such as singing, whistling and prolonged vowels.      Participants will be admitted to the NIH Clinical Center for each of three visits, which will     last from the afternoon of one day to late afternoon of the following day. At each visit,     patients will complete a questionnaire, baseline speech recording, and a test for sedation     level. They will take three pills-either dextromethorphan, lorazepam, or placebo-one every 6     hours. Vital signs will be checked every 6 hours and the level of sedation during waking     hours will be monitored. One to three hours after taking the third pill, speech recording,     questionnaire and test of sedation will be repeated to check for possible voice changes.     Patients will be given a different pill at each visit.   "
170039|NCT00055562|"     Subjects are randomized to one of two treatment arms. All subjects are screened for     eligibility within 28 days prior to randomization. The study consists of a treatment phase     and a follow-up phase. Subjects will be treated in repeating 4 week cycles.   "
170040|NCT00055575|"     This study looks at the role of a specific brain chemical system in the mood and attention     symptoms seen in major depression and bipolar disorders using functional brain imaging.   "
170041|NCT00055588|"     This study will identify changes that occur in the nervous system of healthy normal     volunteers while they are learning a cycling task.      Healthy subjects 18 years of age and older who can cycle for 16 minutes may be eligible for     this study. Candidates will be screened with a brief medical history and physical     examination.      Participants will be assigned to one of three groups:        -  Complex training: Cycling for 16 minutes at a constant speed of 60 rpm with frequent          changes in pedal resistance.        -  Simple training: Cycling for 16 minutes at a constant speed of 60 rpm with no changes in          pedal resistance.        -  No training: Remaining seated on the bike for 16 minutes performing no exercise.      Participants will cycle for 16 minutes for the training task, plus 4 minutes before and after     the training. Reflexes will be measured with nerve conduction studies and somatosensory     evoked potential (SSEP) recordings before and after training. Nerve conduction studies     measure the speed with which nerves conduct electrical impulses and the strength of the     connection between the nerve and the muscle. For these studies, a probe is placed on the skin     over the calf muscles and the knee to deliver a small electrical stimulus, and wires are     taped to the skin to record the impulses. SSEP recordings, which measure of the excitability     of the brain to sensory stimuli, are collected from electrodes placed on the scalp.      After the training period, multiple train stimulation (MTS) is applied for 10 minutes. For     MTS, weak electrical currents are delivered for 10 seconds every 10 seconds. These stimuli     produce a buzzing sensation without pain, discomfort, or muscle twitching. The MTS is     followed by another 4 minutes of cycling.      Participants also undergo transcranial magnetic stimulation (TMS). For this procedure, an     insulated wire coil is held over the scalp. A brief electrical current is passed through the     coil, creating a magnetic pulse that travels through the scalp and skull and causes small     electrical currents in the brain cortex (outer part of the brain). The stimulation may cause     twitching in the muscles of the face, arm, or leg. The electrical activity of the muscles is     recorded with a computer or other recording device, using electrodes attached to the skin     with tape.   "
170042|NCT00055601|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy (RT) uses high-energy x-rays to     damage tumor cells. It is not yet known which regimen of combination chemotherapy plus     radiation therapy with or without surgery is more effective in treating bladder cancer.      PURPOSE: Randomized phase II trial to study the effectiveness of two combination chemotherapy     regimens and radiation therapy with or without radical cystectomy in treating patients who     have stage II or stage III bladder cancer.   "
170043|NCT00055614|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have     advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.   "
170044|NCT00055640|"     RATIONALE: Analyzing genes that are present in cancer cells may be useful as a method for     predicting the response of non-Hodgkin's lymphoma to cancer treatment. Imaging procedures     such as positron emission tomography (PET) scans may improve the ability to measure how well     cancer has responded to treatment.      PURPOSE: This phase II trial is studying molecular risk assessment to see how well it works     in predicting response to therapy in patients who are receiving treatment for non-Hodgkin's     lymphoma.   "
170045|NCT00055653|"     RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were     destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.      PURPOSE: Phase II trial to study the effectiveness of allogeneic umbilical cord blood     transplantation in treating patients who have leukemia, lymphoma, or nonmalignant hematologic     disorders.   "
170046|NCT00055666|"     RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host     disease of the gastrointestinal tract.      PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host     disease of the gastrointestinal tract that has not responded to previous therapy.   "
170047|NCT00055679|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is more effective in treating early breast     cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of     combination chemotherapy in treating women who have stage I breast cancer.   "
170048|NCT00055692|"     This phase II trial is to see if bevacizumab works in treating patients who have unresectable     nonmetastatic liver cancer that has not spread to the main portal vein. Monoclonal     antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or     deliver cancer-killing substances to them.   "
170049|NCT00055705|"     RATIONALE: PV701 may be able to kill tumor cells while leaving normal cells undamaged.      PURPOSE: Phase I trial to study the effectiveness of PV701 in treating patients who have     advanced or recurrent ovarian epithelial, fallopian tube, primary peritoneal, colorectal, or     other cancer found primarily within the peritoneal cavity.   "
170050|NCT00055718|"     RATIONALE: Silymarin (milk thistle extract) is an herb that may be effective in treating     liver disorders caused by cancer therapy.      PURPOSE: Randomized phase II trial to study the effectiveness of silymarin in treating     patients who have acute lymphoblastic leukemia with chemotherapy-related side effects to the     liver.   "
170054|NCT00055783|"     RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating     patients who have progressive or recurrent Hodgkin's lymphoma.   "
170055|NCT00055809|"     This randomized phase II trial is to see if combining bevacizumab with PEG-interferon alfa-2b     works in treating patients who have metastatic or unresectable carcinoid tumors. Monoclonal     antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or     deliver cancer-killing substances to them. PEG-interferon alfa-2b may stop the growth of     cancer by stopping blood flow to the tumor. Combining bevacizumab with PEG-interferon alfa-2b     may kill more cancer cells   "
170056|NCT00055822|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells. Oblimersen     may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the     drugs.      PURPOSE: Phase I/II trial to study the effectiveness of combining oxaliplatin, fluorouracil,     and leucovorin with oblimersen in treating patients who have unresectable, metastatic, or     recurrent colorectal cancer.   "
170057|NCT00055835|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine, and     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or     die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy     before radiation therapy, and combining chemotherapy with radiation therapy, may kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of neoadjuvant gemcitabine, paclitaxel,     and carboplatin followed by cisplatin and radiation therapy in treating patients who have     locally advanced or recurrent carcinoma (cancer) of the urothelium.   "
170058|NCT00055848|"     RATIONALE: Genetic studies may help in understanding the genetic processes involved in the     development of some types of cancer.      PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer     or adenomatous polyps.   "
170059|NCT00055861|"     This phase II trial is to see if combining bevacizumab with docetaxel works in treating women     who have locally advanced or metastatic breast cancer. Drugs used in chemotherapy work in     different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal     antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or     deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody     therapy may kill more tumor cells.   "
170060|NCT00055874|"     RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem     cells. Also, imatinib mesylate may stop the growth of cancer cells by blocking the enzymes     needed for cancer cell growth. Interferon alfa may interfere with the growth of cancer cells     and slow the growth of cancer. When the healthy stem cells from a donor are infused into the     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood     cells, and platelets. It is not yet known which treatment regimen is most effective in     treating chronic phase chronic myelogenous leukemia.      PURPOSE: This randomized phase III trial is studying imatinib mesylate with or without     interferon alfa or cytarabine to see how well it works compared with interferon alfa followed     by donor stem cell transplant in treating patients with newly diagnosed chronic phase chronic     myelogenous leukemia.   "
170061|NCT00055887|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Drugs such as efaproxiral may make the tumor cells more sensitive to radiation therapy. It is     not yet known if chemotherapy combined with radiation therapy is more effective with or     without efaproxiral in treating non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy combined     with radiation therapy with or without efaproxiral in treating patients who have stage III     non-small cell lung cancer.   "
170062|NCT00062907|"     The purpose of this trial is to examine the safety and immunogenicity of a therapeutic     vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with     early stage non-small cell lung cancer. The vaccine regimen will consist of two fixed doses     of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S).     The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients.   "
170100|NCT00063895|"     This phase I/II trial is studying the side effects of erlotinib and to see how well it works     in treating patients with metastatic or unresectable non-small cell lung cancer, ovarian     cancer, or squamous cell carcinoma (cancer) of the head and neck. Erlotinib may stop the     growth of tumor cells by blocking the enzymes necessary for their growth   "
170063|NCT00062933|"     Ocular melanoma, or cancer of the eye, is a rare form of cancer that can spread to the liver.     A tumor in the liver, because of its size or location, sometimes cannot be removed with     surgery.      The purpose of this study is to determine whether chemotherapy delivered only to the liver,     called isolated hepatic perfusion (IHP), followed by systemic (to the whole body)     chemotherapy improves the ability to treat cancer.      Study participants must be 18 years or older and have ocular melanoma that has spread to the     liver. Before enrolling in the study, they will undergo the following evaluations: a physical     exam; x-rays; blood tests; electrocardiogram; computed tomography (CT) scan of the chest,     abdomen and pelvis; and a magnetic resonance imaging (MRI) scan of the liver.      The study includes a 15-minute quality-of-life questionnaire. Participants will complete the     questionnaire 7 times over a period of 2 years to help investigators gauge their health     status and progress.      A laparotomy is done, which allows a surgeon to view the tumor in the liver through a small     incision in the abdomen while the patient is under general anesthesia. Sometimes the tumor     can spread outside the liver in a way that cannot be seen by pre-operative scans. When this     happens, the participant is ineligible to continue in the study, since an important part of     the treatment is given only to the liver.      If the laparotomy reveals that the participant is eligible for the remainder of the study,     the participant will receive IHP treatment during the surgery. Plastic tubes called catheters     are placed in the vein and artery that feed and drain the liver. This creates a separate     blood supply for the liver alone. Heated chemotherapy is then given into the liver blood     supply for one hour, while being carefully kept out of the rest of the body.      After recovering from the surgery, eligible participants will receive a systemic chemotherapy     called temozolomide for up to one year. This chemotherapy is taken by mouth in capsule form.      Participants will be asked to return to NIH 10-11 times during the first year to evaluate     their progress.   "
170078|NCT00063128|"     This is a research study of a study drug known as LY041001 or human insulin inhalation powder     (HIIP). HIIP is a powder form of insulin made to be inhaled through the mouth and into the     lungs using a special handheld device.   "
170064|NCT00062946|"     The purpose of this study is to measure molecules on or in cells that interact with a     chemical in the nervous system, called dopamine. Investigators will obtain two kinds of     images of the brain-a position emission tomography (PET) scan and a magnetic resonance     imaging (MRI) scan.      Thirty-eight participants aged 18 to 45 will be enrolled in this study. They must have no     history of medical or psychiatric illness, including substance abuse. Participants will have     four appointments at NIH. On the first visit, they will undergo a physical exam, a medical     history, and lab tests. The second and third visits will involve PET scans and the fourth     visit will involve an MRI scan.      Participants will be compensated up to $430 for their involvement in this study.   "
170065|NCT00062959|"     Problem behaviors such as drug use, violence, and school misconduct increase during     adolescence. This study evaluated a program designed to prevent problem behaviors in middle     school students; the program includes classroom instruction for students and home instruction     for parents.   "
170066|NCT00062972|"     People with multiple sclerosis (MS) suffer from cognitive and other brain problems. This     study will examine the effectiveness of the drug donepezil and of sugar water for enhancing     memory in individuals with MS. Donepezil (also known as Aricept) has been FDA approved for     improving memory and learning in individuals with Alzheimer's disease.   "
170067|NCT00062985|"     The aim of the present study is to evaluate the effectiveness of two different delivery     formats for weight management in a managed care setting. Mail-based weight counseling and     phone-based weight counseling will be compared to each other and a control condition. Primary     outcomes are participation rates in programs, weight change, and cost.   "
170068|NCT00062998|"     We have recently validated a new device for measurement of physical activity and found it to     detect type, duration and intensity of many types of physical activity at better than 98%     accuracy. After further validating this device to determine if it can also accurately assess     energy expenditure, we will use it to collect cross-sectional data on free-living physical     activity and energy expenditure in adolescent girls.   "
170069|NCT00063011|"     Osteoporosis is a major public health problem. Prevention of osteoporosis depends in part on     good bone development in childhood and adolescence. This study will evaluate a weight-bearing     exercise program and high-calcium diet on bone development in adolescent girls.   "
170070|NCT00063024|"     Osteoporosis is a condition defined by decreased bone mass. Osteoporosis generally affects     older women and can lead to bone fractures. One way to prevent osteoporosis is to build     strong, healthy bones during childhood. This study will evaluate a program designed to     improve girls' bones. The program encourages eating foods rich in calcium and participating     in physical activity.   "
170071|NCT00063037|"     Calcium is important for healthy bone growth in children. Poor bone growth and development     during childhood can lead to osteoporosis later in life. This study will evaluate a nutrition     education program designed to increase the amount of calcium children receive. The study will     determine whether the program will result in long-term dietary changes and healthier bones in     children.   "
170072|NCT00063050|"     The purpose of this study is to determine whether educating parents about health and behavior     management techniques will increase physical activity, calcium intake, fitness, and bone     density in their children.   "
170073|NCT00063063|"     The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD     Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both     mothers and infants, and the therapies used and outcomes of the infants. The information     collected is not specific to a disease or treatment (i.e., it is generic). Data are     analyzed to find associations and trends between baseline information, treatments, and infant     outcome, and to develop future NRN trials.   "
170074|NCT00063076|"     The goal of this clinical research study is to find the most effective dose of Targretin®     (bexarotene) Gel 1% that can be given to patients as a treatment for alopecia areata. The     safety and tolerability of this drug will also be studied.      Objectives:        1. Determine the safety and tolerability of Targretin® Gel 1% in the treatment of patients          with alopecia areata.        2. Determine the efficacy of Targretin® Gel 1% in the treatment of patients with alopecia          areata.   "
170075|NCT00063089|"     Altastaph has been developed to help the removal of S. aureus from the bloodstream. The main     objective of this study will be to test the safety and behavior of Altastaph in patients with     S.aureus bacteremia and continuing fever   "
170076|NCT00063102|"     The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how     long the tumor shrinkage can be maintained in patients with breast cancer after having had     taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be     off drug for 7 days before starting the next cycle of drug.   "
170151|NCT00064610|"     The purpose of this study is to evaluate how safe PS-341(VELCADE) is when given with     Docetaxel (Taxotere) to patients with androgen-independent prostate cancer, and also to see     what effects (good and bad) it has on you and on your cancer.   "
170152|NCT00064623|"     The purpose of the study is to determine if an investigational drug, NGX-4010     (high-concentration capsaicin patch), is effective in treating painful HIV-associated     neuropathy.   "
170077|NCT00063115|"     Ideomotor apraxia, a disorder that affects patients with stroke and a variety of other brain     lesions, features disturbed timing, sequence, and spatial organization of skilled movements.     This study will look at how different areas of the human brain control fine hand movements.      Thirty-five participants 21 years and older will be enrolled in this study-25 healthy,     right-handed people, and 10 stroke patients. They will undergo two outpatient sessions, each     lasting up to 3 hours. The first visit for the stroke patients will occur between 2 weeks and     3 months after the stroke; the second visit will be at least 6 months after the stroke.      Participants will have a physical exam, give a medical history, and complete a questionnaire.     Then they will undergo magnetic resonance imaging (MRI) scans. They will lie in the MRI     scanner and will be asked to do a number of skilled hand movements using the right hand (such     as pretending to use a hammer or waving goodbye) in response to directions that will appear     on a screen mounted over their head. Their movements will be recorded on videotape during the     procedures.   "
172638|NCT00102856|"     The purpose of this study is to determine whether rivastigmine or pramipexol are effective in     boosting semantic language acquisition in healthy subjects.   "
170079|NCT00063141|"     The purpose of this study is to determine whether overall survival is prolonged in subjects     with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated     with cetuximab in combination with irinotecan compared with irinotecan alone as second-line     therapy following treatment with a fluoropyrimidine and oxaliplatin based,     non-irinotecan-containing regimen.   "
170080|NCT00063154|"     The purpose of this study is to determine if the study drug pertuzumab is effective in     treating patients with advanced lung cancer that has recurred following prior chemotherapy.   "
170081|NCT00063180|"     Patients with stroke sometimes have a condition called diaschisis, a loss of function in a     part of the brain located some distance from the original stroke-injury site. Doctors do not     know why this happens.      The purpose of this study is to get a better understanding as to why diaschisis occurs by     studying people who have experienced a stroke and people who have aged in good health.      Forty-four participants who are older than 40 year of age will be enrolled in this study-18     healthy people and 26 stroke patients. They will have 3 to 4 study visits. The first visit     will involve a medical history and a physical and neurological exam. Participants will then     have a magnetic resonance imaging (MRI) scan, either on the first visit or on a later day. On     the next visit, they will undergo a position emission tomography (PET) scan. Finally, they     will return for another MRI scan.   "
170082|NCT00063193|"     The goal of this study is to assess the impact of minocycline and creatine on the progression     of Parkinson's disease, in order to determine whether it is reasonable to proceed with     further study of either of these agents.   "
170083|NCT00063206|"     Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR     versus subjects receiving placebo.      Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global     evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric     Rating Scale for Depression, 17-item [HAM-D<sub>17</sub>] < 7) versus those subjects     receiving placebo.   "
170084|NCT00063219|"     This non-randomized, open-label clinical trial is designed to determine safety and clinical     activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with     non-small cell lung cancer. Clinical activity will be evaluated by determining the percentage     of patients with an objective tumor response after treatment with MAC-321. Patients must have     been previously treated with a platinum-containing chemotherapy regimen.      A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321     intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will     receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside     of this research trial.   "
170085|NCT00063232|"     Nonalcoholic Steatohepatitis (NASH) is associated with progressive liver disease, fibrosis,     and cirrhosis. Although the cause of NASH is unknown, it is often associated with obesity,     type 2 diabetes, and insulin resistance. At present, there are no approved treatments for     NASH patients, but an experimental approach has focused on improving their insulin     sensitivity. Metformin is one of the most commonly used medications for the treatment of     diabetes.      The purpose of this study is to determine whether the medical problems of NASH patients,     specifically liver damage, improves when their insulin sensitivity is enhanced with     metformin.      The study will last 3 to 5 years and will enroll up to 30 patients. Participants will undergo     a complete medical examination, a series of lab tests, and a liver biopsy. They will then     start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage     twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to     1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will     undergo a repeat medical examination and liver biopsy.   "
170086|NCT00063245|"     The purpose of this study is to determine whether a special coil designed for magnetic     stimulation of areas deep in the brain can affect mood and emotion in healthy volunteers.     Researchers hope to better understand how the brain controls mood and motivation and what     goes wrong with this process in disease.      For transcranial magnetic stimulation (TMS), a wire coil is held over the scalp. A brief     electrical current passes through the coil and creates a magnetic pulse that stimulates the     brain.      Eighteen participants, 9 men and 9 women, will be enrolled in this study. They will be     assigned to one or both of the following two experiments.      Experiment 1      In this experiment, researchers will test the effectiveness of a new type of wire coil. They     will deliver magnetic impulses of varying strength. Approximately 150 stimulations will be     given over of about 20 minutes. To determine whether the coil causes any problem with     hearing, participants will undergo a hearing test immediately before and after the     experiment.      Experiment 2      This experiment, which has two parts, is designed to determine whether TMS can affect mood.     In the first part, participants will be asked to report any changes in mood before, during     and after the magnetic stimulation. In the second part, they will be asked to choose between     sets of 2 identical pictures-choosing one will result in full magnetic stimulation, choosing     the other will result in stimulation at 10 percent of full intensity.      Participants will be compensated up to $100 for their involvement in this study.   "
170101|NCT00063934|"     This phase I/II trial is studying the side effects and best dose of oblimersen when given     together with doxorubicin and docetaxel and to see how well they work in treating women with     metastatic or locally advanced breast cancer. Drugs used in chemotherapy, such as doxorubicin     and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing     or die. Oblimersen may increase the effectiveness of doxorubicin and docetaxel by making the     tumor cells more sensitive to the drugs.   "
170102|NCT00063947|"     This phase I trial is studying the side effects and best dose of erlotinib when given     together with gemcitabine and radiation therapy in treating patients with locally advanced     unresectable pancreatic cancer. Erlotinib may stop the growth of tumor cells by blocking the     enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with gemcitabine     may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.   "
170198|NCT00065247|"     The Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project is an after-school     program that includes weight loading physical activity, nutrition and bone health education,     and calcium-rich snacks. The program is designed to improve bone health in early elementary     school children.   "
170090|NCT00063765|"     This study will evaluate the safety of a ciliary neurotrophic factor (CNTF) implant placed in     the eye to allow the release of CNTF directly on the retina. The results of this study may     lead to a larger investigation of CNTF implants to treat retinitis pigmentosa (RP), a     progressive degenerative eye disease that begins with loss of peripheral vision and night     blindness and often leads to blindness in later life.      Currently, there are no effective treatments for RP. Researchers have found, however, that     certain proteins, called ciliary neurotrophic factor (CNTF), can partially protect cells in     the eye if given directly inside the eye. A major challenge in treating RP is to deliver     medicine directly into the eye. One way to ensure that CNTF gets into the eye is to     surgically place an implant inside the eye to release the protein.      Patients 18 years of age and older with retinitis pigmentosa whose visual acuity is 20/100 or     worse may be eligible for this study. Candidates will be screened with a medical history,     physical examination, eye examinations, and eye photographs. The eye examination includes     measurement of visual acuity and eye pressure, examination of the pupils and eye movements,     and examination of the lens and back of the eye. In addition, patients will have the     following tests:        -  Visual field test: Patients look at a central spot on a white screen and tell the          examiner whenever they see a small light appear at other places on the screen.        -  Electroretinogram (ERG): Electrodes are taped to the patient's forehead. Special contact          lenses are placed on the eyes, similar to normal contact lenses, after the eye has been          numbed with drops. The contact lenses sense small electrical signals generated by the          retina. The ERG measures the electrical activity of the retina when it is stimulated by          light. For the ERG recording, the patient looks inside a large, hollow, dark sphere, and          sees flashes of light, first in the dark, and then with a light turned on in the sphere.        -  Optical coherence tomography: This test, done with the machine used to examine the eye,          measures retinal thickness by producing cross-sectional pictures of the retina.      Participants undergo surgery at the NIH Clinical Center in a 30-minute operation to place the     implant in one eye. The surgery is done under local anesthetic. Before the procedure,     patients are given a steroid injection along side the eye to minimize inflammation after     surgery. Following the procedure, patients return for follow-up visits once a month for 6     months. At these visits, several of the exams described above are repeated to evaluate     treatment effects and check for adverse side effects. After 6 months, the implant is     surgically removed. Post-surgical care for both implant and explant surgeries include     examinations the day and week after surgery to examine the wound, a high dose of steroid     immediately after surgery, oral antibiotics for 7 days, and eye drops for 1 week to prevent     infection and inflammation.   "
170091|NCT00063778|"     The purpose of this study is to see if different doses of an experimental HIV vaccine are     safe and to study how the immune system responds to the vaccine. The vaccine will be tested     in healthy, HIV uninfected volunteers. AVX101 contains only one of the many substances that     HIV needs to make more copies of itself; therefore, the vaccine cannot cause HIV or AIDS.   "
170092|NCT00063791|"     The purpose of this study is to give patients who have had 4 or more prior lines of therapy     for multiple myeloma access to VELCADE. The study is for patients who are not eligible for     other clinical trials with VELCADE and for who VELCADE would otherwise not be available.   "
170093|NCT00063804|"     Most currently approved anti-HIV drugs work by stopping the replication of HIV after it has     entered cells. AMD070 (also known as AMD11070) is designed to block HIV from entering cells     and may be effective in treating patients who have developed resistance to or are unable to     take other anti-HIV drugs. This study will evaluate the safety of different doses of AMD070     along with AMD070 boosted with ritonavir (RTV) in HIV uninfected men.   "
170094|NCT00063817|"     This study will examine the safety and effectiveness of a combination kidney and bone marrow     transplant from a relative with the same (or nearly the same) blood cell type as the     transplant recipient. An investigational medication will be given prior to and after the     transplant to help protect the transplanted kidney from attack by the body's immune system.   "
170095|NCT00063830|"     This is a multi-center trial in the US and Europe to test the safety, efficacy and     tolerability of alicaforsen (ISIS 2302), a new type of drug called an antisense drug, in     patients with mild to moderate active Ulcerative Colitis (UC). Alicaforsen is designed to     reduce the production of a specific protein, called ICAM-1, a substance that plays a     significant role in the increase of inflammation and is likely to be involved in inflammatory     bowel diseases such as ulcerative colitis. The ISIS 2302-CS27 study will compare four dosing     regimens and determine the minimum effective dose of alicaforsen enema in UC patients over     six weeks as compared to a placebo enema. (The probability of receiving active formulation is     4:1). The primary objective of this study is to evaluate the percentage reduction in DAI at     Week 6.   "
170096|NCT00063843|"     The primary objective is to determine the tolerability and safety, from days 0 to 210, of     escalating doses of rPA either with or without Alhydrogel (an adjuvant; used to increase the     action of the principle drug) given in a two-dose, intramuscular regimen to health adults.     The secondary objective is to evaluate antibody responses to rPA, from days 0 to 210,     following one of four escalating doses of vaccine given with and without Alhydrogel given in     a two-dose series to healthy adults, and to compare immune responses following rPA with those     following BioThrax (tm) given by either the intramuscular or SQ route. The tertiary objective     is to describe the antibody kinetics following vaccination. This information will be used to     determine the most probable optimal dose of rPA and/or Alhydrogel that is safe, well     tolerated, and maximally immunogenic for use in future phase II trials.   "
170097|NCT00063856|"     The primary purpose of this study is to find out the risk of spreading the vaccine virus,     vaccinia, from the smallpox vaccination site when different types of bandages are used to     cover the site. The study will also look at how each bandage type affects the healing of the     sore. Study participants will include healthy individuals, 18-50 years old, who have not     previously received a smallpox vaccine and healthy individuals, 18-50 years old, who have     received a previous smallpox vaccine. All participants will receive the smallpox vaccine and     be randomly assigned to 1 of 3 different bandage groups to cover the vaccine site: standard     gauze dressing attached with paper tape, Opsite gauze-impregnanted occlusive dressing     (attached by paper tape and waterproof), and Allevyn hydropolymer dressing (which is     self-adhesive and highly absorbent). Volunteers will be involved in study related procedures     for up to 252 days.   "
170098|NCT00063869|"     The objective of the study is to evaluate the safety and efficacy of etanercept in comparison     with placebo in a double-blind, parallel, randomized fashion in subjects with idiopathic     pulmonary fibrosis (IPF) who failed previous therapy. The treatment period will be up to 1     year. The primary objective is evaluation of safety and efficacy. Secondary: The secondary     objective is to evaluate quality of life (QoL) and pharmacokinetics (PK).   "
170099|NCT00063882|"     RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells.     Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to     kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy     may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more     effective with or without external-beam radiation therapy in treating prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial     brachytherapy with or without external-beam radiation therapy in treating patients who have     prostate cancer.   "
170103|NCT00063960|"     RATIONALE: Drugs used in chemotherapy such as floxuridine and irinotecan use different ways     to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses     a catheter to deliver chemotherapy directly to the liver. Combining more than one drug and     giving them in different ways may kill any tumor cells remaining after surgery.      PURPOSE: Phase II trial to study the effectiveness of systemic irinotecan and hepatic     arterial infusion with floxuridine after surgery in treating patients who have hepatic     (liver) metastases from colorectal cancer.   "
170104|NCT00063973|"     This phase I trial is studying the side effects and best dose of cilengitide in treating     children with recurrent, progressive, or refractory primary CNS tumors. Cilengitide may slow     the growth of brain cancer cells by stopping blood flow to the tumor.   "
170105|NCT00063986|"     RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive     types of surgery for esophageal cancer that may have fewer side effects and improve recovery.      PURPOSE: This phase II trial is studying how well laparoscopic-assisted surgery and     video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for     high-grade dysplasia of the esophagus or stage I, stage II, or stage III esophageal cancer.   "
170106|NCT00063999|"     This randomized phase III trial compares how well two different combination chemotherapy     regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and     paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has     come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride,     cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. It is not yet known which combination chemotherapy regimen is more effective in     treating endometrial cancer.   "
170107|NCT00064012|"     RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor     cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer     cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether     bortezomib is more effective with or without docetaxel in treating patients with advanced     non-small cell lung cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without     docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV     non-small cell lung cancer.   "
170108|NCT00064025|"     This phase II trial is studying how well medroxyprogesterone works in treating patients with     endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not     including the cervix). Hormone therapy using medroxyprogesterone may be effective in treating     endometrioid cancer.   "
170109|NCT00064038|"     RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer     cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple     myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is     more effective with or without lenalidomide in treating multiple myeloma.      PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see     how well they work compared to dexamethasone alone in treating patients with previously     untreated stage I, stage II, or stage III multiple myeloma.   "
170110|NCT00064051|"     RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor     cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by     blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more     cancer cells by making them more sensitive to the drug.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with 3-AP works     in treating patients with unresectable or metastatic pancreatic cancer.   "
170111|NCT00064064|"     RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor     cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by     blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more     cancer cells by making them more sensitive to the drug.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with 3-AP in     treating patients who have metastatic non-small cell lung cancer.   "
170112|NCT00064077|"     This randomized phase III trial is studying four combination chemotherapy regimens using     cisplatin to compare how well they work in treating women with stage IVB, recurrent, or     persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel,     vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing     so they stop growing or die. It is not yet known which combination chemotherapy regimen     containing cisplatin is most effective in treating cervical cancer.   "
170113|NCT00064090|"     RATIONALE: Drugs used in chemotherapy such as cytarabine use different ways to stop cancer     cells from dividing so they stop growing or die. 3-AP may stop the growth of cancer cells by     blocking the enzymes necessary for cancer cell growth and may help cytarabine kill more     cancer cells by making them more sensitive to the drug.      PURPOSE: Phase I trial to study the effectiveness of combining cytarabine with 3-AP in     treating patients who have relapsed or refractory hematologic cancer.   "
170114|NCT00064103|"     This phase I/II trial is studying the side effects and best dose of gene therapy and to see     how well it works in preventing cancer in patients with premalignant carcinoma of the oral     cavity or pharynx. Inserting the p53 gene into a person's tumor cells may improve the body's     ability to kill the tumor cells   "
170115|NCT00064116|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells     and either kill them or deliver cancer-killing substances to them without harming normal     cells. It is not yet known whether combination chemotherapy is more effective with or without     rituximab in treating patients with non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying four different combination chemotherapy     regimens and rituximab to see how well they work compared to four different combination     chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.   "
170156|NCT00064675|"     To evaluate individual differences in cardiovascular responses to acute stress in Black     adolescents.   "
170157|NCT00064688|"     To search for the genetic cause of the metabolic syndrome, a lipid disorder that poses a     major risk for coronary heart disease.   "
170116|NCT00064129|"     This phase I trial is studying the side effects and best dose of ipilimumab when given with     sargramostim in treating patients with metastatic prostate cancer. Monoclonal antibodies can     locate tumor cells and either kill them or deliver tumor-killing substances to them without     harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the     number of immune cells found in bone marrow or peripheral blood and may help a person's     immune system kill more tumor cells.   "
170117|NCT00064142|"     This phase II trial studies how well halofuginone hydrobromide works in treating patients     with human immunodeficiency virus (HIV)-related Kaposi's sarcoma. Halofuginone hydrobromide     ointment may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.   "
170118|NCT00064181|"     RATIONALE: Drugs used in chemotherapy such as irinotecan, capecitabine, leucovorin, and     fluorouracil use different ways to stop tumor cells from dividing so they stop growing or     die. Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor.     It is not yet known which combination chemotherapy regimen with or without celecoxib is more     effective in treating metastatic colorectal cancer.      PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens     and celecoxib to see how well they work compared to two combination chemotherapy regimens     alone in treating patients with metastatic colorectal cancer.   "
170119|NCT00064194|"     RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the     development or recurrence of cancer. Vitamin E, selenium, and soy protein may be effective in     preventing the development of prostate cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of combining vitamin E,     selenium, and soy protein in preventing prostate cancer in patients who have high-grade     prostate neoplasia.   "
170120|NCT00064207|"     RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after     surgery may kill any tumor cells that remain after surgery. It is not yet known whether     giving gemcitabine together with radiation therapy is more effective than gemcitabine alone     following surgery in treating pancreatic cancer.      PURPOSE: This randomized phase II/III trial is studying how well giving gemcitabine together     with radiation therapy works and compares it to gemcitabine alone in treating patients who     have undergone surgery for pancreatic cancer.   "
170121|NCT00064220|"     RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who     have advanced or metastatic soft tissue sarcoma.   "
170122|NCT00064233|"     RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary     for cancer cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in     treating patients with chronic phase chronic myelogenous leukemia that is resistant to     imatinib mesylate.   "
170123|NCT00064246|"     Phase I/II trial to study the effectiveness of combining yttrium Y 90 ibritumomab tiuxetan     with rituximab in treating patients who have localized or recurrent lymphoproliferative     disorder after an organ transplant. Monoclonal antibodies such as yttrium Y 90 ibritumomab     tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive     cancer-killing substances to them without harming normal cells   "
170124|NCT00064259|"     Drugs used in chemotherapy such as cisplatin and fluorouracil use different ways to stop     tumor cells from dividing so they stop growing or die. Oblimersen may increase the     effectiveness of chemotherapy by making tumor cells more sensitive to the drugs. This phase     I/II trial is studying the side effects and best dose of oblimersen when given with cisplatin     and fluorouracil and to see how well they work in treating patients with locally advanced,     recurrent, or metastatic cancer of the esophagus, gastroesophageal junction, or stomach.   "
170125|NCT00064272|"     RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients     receiving chemotherapy for cancer.      PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or     preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.   "
170126|NCT00064285|"     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes     necessary for cancer cell growth. Drugs used in chemotherapy such as flavopiridol use     different ways to stop cancer cells from dividing so they stop growing or die. Combining     imatinib mesylate with flavopiridol may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol and     imatinib mesylate in treating patients with hematologic cancer.   "
170127|NCT00064298|"     RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the     development or recurrence of cancer. Fruit and vegetable extracts may be effective in     preventing the recurrence or further development of head and neck cancer.      PURPOSE: This randomized phase II trial is studying how well fruit and vegetable extracts     work in preventing the recurrence of stage I, stage II, stage III, stage IVA, or stage IVB     head and neck cancer.   "
170128|NCT00064311|"     RATIONALE: Antifungals such as ravuconazole may be effective in preventing fungal infections     in patients undergoing chemotherapy and stem cell transplantation.      PURPOSE: Phase I/II trial to study the effectiveness of ravuconazole in preventing fungal     infections in patients undergoing allogeneic stem cell transplantation.   "
170129|NCT00064324|"     Phase II trial to study the effectiveness of perifosine in treating patients who have     advanced soft tissue sarcoma. Drugs used in chemotherapy such as perifosine use different     ways to stop tumor cells from dividing so they stop growing or die.   "
170130|NCT00064337|"     RATIONALE: Drugs used in chemotherapy such as melphalan work in different ways to stop cancer     cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral     stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and     kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving melphalan together with autologous     stem cell transplantation works in treating patients with multiple myeloma or primary     systemic amyloidosis.   "
170158|NCT00064701|"     The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate     mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney     transplant recipients.   "
170131|NCT00064350|"     RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in     vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different     human tumor types including colon, pancreatic, lung, and ovarian. This activity was     cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is     suspended while the drug is administered but returns to baseline rates when the agent is     withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the     activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized     discontinuation design was adopted in the present trial, conducted in a population who were     potentially sensitive to sorafenib.      PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works     compared to placebo in treating patients with refractory non-small cell lung cancer.   "
170132|NCT00064363|"     RATIONALE: Drugs used in chemotherapy such as talampanel use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well talampanel works in treating patients with     recurrent, progressive high-grade glioma.   "
170133|NCT00064376|"     RATIONALE: Paricalcitol is a form of vitamin D that may help myelodysplastic cells develop     into normal bone marrow cells.      PURPOSE: Phase II trial to study the effectiveness of paricalcitol in treating patients who     have myelodysplastic syndrome.   "
170134|NCT00064389|"     The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic     albuterol based on the frequencies of adverse events reporting during a 12-month period of     chronic dosing of adolescent and adult subjects with asthma.   "
170135|NCT00064402|"     The purpose of this study is to assess the bronchodilator effect and safety of multiple daily     doses of arformoterol administered for 12 weeks as maintenance treatment in patients with     COPD   "
170136|NCT00064415|"     The purpose of this study is to determine the long-term safety of arformoterol over a period     of 12 months in subjects with COPD   "
170137|NCT00064428|"     This is a randomized, double blindcontrolled, parallel group, multi-center, multinational     study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction)     randomized within 24 hours of the onset of symptoms.   "
170138|NCT00064441|"     The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535     compared to a placebo in patients with active Ulcerative Colitis.      Depending on their response, participants will be offered the investigational medication for     up to one year after the study's completion at select sites.   "
170139|NCT00064454|"     The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535     compared to a placebo in patients with active Ulcerative Colitis.      Depending on their response, participants will be offered the investigational medication for     up to one year after the study's completion at select sites.   "
170140|NCT00064467|"     This is a study of Major Depressive Disorder (MDD) in patients with decreased energy,     pleasure and interests.   "
170141|NCT00064480|"     To conduct a person-level meta-analysis by pooling 9 United States studies with both black     and white cohorts.   "
170142|NCT00064493|"     To identify genetic variation in reverse cholesterol transport (RCT) and its role in     cardiovascular disease and atherosclerosis.   "
170143|NCT00064506|"     To assess genetic variation in 87 different cardiovascular disease candidate genes and to     measure the associations of these variants with cardiovascular disease and its risk factors.   "
170144|NCT00064519|"     To investigate the genetics of C reactive protein in families with myocardial infarction.   "
170145|NCT00064532|"     To assess the associations of serum sex hormones with the presence and progression of     subclinical atherosclerosis.   "
170146|NCT00064545|"     To evaluate common genetic variations, that in combination with exposure to tobacco smoke,     may modify the risk of atherosclerosis.   "
170147|NCT00064558|"     To evaluate whether genetic variation in selected candidate genes is associated with risk of     sudden cardiac death in the general population.   "
170148|NCT00064571|"     Unilateral vocal fold paralysis (UVFP) is caused by injury to the nerve to the affected vocal     fold. The injury to the vocal fold makes the affected person's voice sound breathy. Voice     therapy is usually tried first, and, if unsuccessful, surgical treatment is considered. The     standard surgical treatment is called vocal fold medialization and aims to bring the injured     cord to the midline. An alternative surgical treatment, vocal fold reinnervation, aims to     bring a new nerve supply to the injured vocal fold. The reinnervation operation, which has     some potential advantages over the medialization operation also requires several months for     final results to be gained. The goal of this multicenter, randomized clinical trial is to see     which of the two surgical treatments produces a better outcome.      In order to participate in this study patients with UVFP must meet all entry criteria and     must be released from voice therapy by a speech-language pathologist. Information collected     for the study (pre-surgery, and at 6 and 12 months after surgery) includes voice recordings,     movies made of vocal fold function, airflow and pressure measurements of the voicebox, and an     outcomes questionnaire.   "
170149|NCT00064584|"     This is the first study of the drug CT53518 when given to humans. The purpose of this study     is to determine the highest dose of CT53518 that can safely be given to patients with Acute     Myelogenous Leukemia (AML) and to identify the side effects associated with taking the drug.     The study will evaluate how CT53518 is absorbed, broken down, and eliminated by the body.     Additionally, the study will evaluate the effects of the drug on a specific type of cell in     bone marrow and blood, known as a blast.   "
170150|NCT00064597|"     This purpose of this study is to develop noninvasive methods of prenatal diagnosis. Fetal     cells can be found in maternal blood. This study is designed to isolate these fetal cells     from a sample of the pregnant woman’s blood and use those cells to test for fetal chromosome     abnormalities.   "
170155|NCT00064662|"     The primary aim of this clinical trial is to compare the treatment success for two surgical     procedures that are frequently used and have similar cure rates, yet have not been compared     directly to each other in a large, rigorously conducted randomized trial. The secondary aims     of the trial are to compare other outcomes for the two surgical procedures, including quality     of life, sexual function, satisfaction with treatment outcomes, complications, and need for     other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four     years.   "
170159|NCT00064714|"     This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the     ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on     beta cell function.      Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells     of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve     the pancreas's ability to produce insulin and help control blood sugar, but it may also     activate the original immune response that caused the diabetes. Thus, this study will examine     the effects of AC2993 alone as well as in combination with immunosuppressive drugs.      Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for     this 20-month study. They must have had diabetes for at least 5 years and require insulin     treatment. Candidates will be screened with a questionnaire, followed by medical history and     physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis,     electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below).     Participants will undergo the following tests and procedures:      Advanced screening phase: Participants undergo a diabetes education program, including     instruction on frequent blood glucose monitoring, dietary education on counting     carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar     (hypoglycemia), and potential treatment with glucagon shots.      Patients must administer insulin via an insulin pump or take at least four injections per day     including glargine (Lantus) insulin.      4-month run-in phase        -  Arginine-stimulated C-peptide test: This test measures the body's insulin production.          The patient is injected with a liquid containing arginine, a normal constituent of food          that increases insulin release from beta cells into the blood stream. After the          injection, seven blood samples are collected over 10 minutes.        -  Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response          of the beta cells to an ordinary meal and the time it takes for food to pass through the          stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood          samples are then drawn through a catheter (plastic tube placed in a vein) every 30          minutes for 4 hours to measure levels of various hormones and the concentration of          acetaminophen.        -  Euglycemic clamp: This test measures the body's level of insulin resistance by measuring          the amount of glucose necessary to compensate for an increased insulin level while          maintaining a prespecified blood glucose level.   "
170160|NCT00064727|"     This study will evaluate the safety and effectiveness of the drug rosiglitazone for improving     heart function in patients with heart failure and glucose intolerance or type II     (adult-onset) diabetes, or both. Because of a lowered sensitivity to the hormone insulin,     patients with type II diabetes or glucose-intolerance do not regulate glucose (sugar)     effectively. Rosiglitazone is used to treat type II diabetes, but it is not commonly given to     patients with heart failure because it can cause leg swelling and, rarely, pulmonary edema.     However, patients with heart failure who also have glucose intolerance or type II diabetes     generally fare worse than those with heart failure alone, and therapies that decrease insulin     resistance may be beneficial to these patients.      Patients 21 years of age and older with heart failure and type II diabetes or glucose     intolerance, or both, may be eligible for this study. Patients must be stable on current     therapy for heart failure and must not have any planned surgeries for coronary artery     disease. Candidates will be admitted to the NIH Clinical Center for from 2 to 7 days for     screening procedures, which include a medical history and physical examination, blood and     urine tests, electrocardiogram (ECG), chest x-ray, magnetic resonance imaging (MRI), exercise     testing, and echocardiography (ultrasound test of the heart).      Participants will be randomly assigned to receive either rosiglitazone or placebo (an     identical-looking pill with no active ingredient). They will take one tablet a day for the     first month, one tablet twice a day for the second month, and then two tablets twice a day     from the third month to the end of the study at 6 months. During the treatment period,     patients will have a history, physical examination, and blood tests every 4 weeks, exercise     testing and echocardiography at 3 and 6 months, and urinalysis, electrocardiogram and MRI at     6 months. To check for fluid accumulation in the legs or lungs, patients will report their     weight and symptoms every 2 weeks throughout the study. After the 6-month treatment period,     patients will be put back on the diabetes medicines they were taking before the study. Their     physicians will be notified of possible modifications in treatment for maintaining optimum     glucose tolerance.      Six months after completing treatment (one year after beginning the study), patients will     return to the Clinical Center for blood tests to measure the long-term effects of     rosiglitazone and to evaluate progress. They will then be invited to return to the clinic for     annual checkups, if possible, or for yearly follow-up by mail or telephone to review their     health status.   "
170161|NCT00064740|"     Advances in treatment has turned HIV/AIDS into a chronic illness. Relaxation response is a     state in which individuals evoke a bodily calm, effecting physiological changes that are     shown to be associated with improved immune functioning. Acupuncture and relaxation are     thought to both induce calm and deep relaxation in mind and body. This trial will study the     combined effects of acupuncture and relaxation response in HIV patients.   "
170162|NCT00064753|"     The purpose of this randomized clinical trial is to determine if lowering homocysteine levels     in renal transplant recipients with a multivitamin will reduce the occurrence of     cardiovascular disease outcomes.   "
170163|NCT00064766|"     Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients     using progestin-only hormonal contraception such as levonorgestrel implants (Norplant).     Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease,     may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This     study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using     Norplant.   "
170164|NCT00064779|"     The experimental anti-cancer drug IL13-PE38QQR, which is being developed for the treatment of     malignant brain tumors, is composed of parts of two proteins: the immune system cytokine IL13     and a toxin from the bacterium Pseudomonas aeruginosa. The IL13 part of the drug binds to     another protein, the IL13 receptor, when this receptor is displayed on the outside surface of     cells. Cells with drug bound to the IL13 receptor take up the drug, and the toxin part of the     drug then kills those cells. Since brain tumor cells display the IL13 receptor, they are     potential targets that may be killed by this drug. This is a pilot study to visualize the     distribution of IL13-PE38QQR infused into and around brain tumor tissue before and after     surgical removal of the tumor in adult patients with recurrent malignant glioma.      Stored tumor tissue will be tested for presence of the receptor protein, which is required     for study entry. Eligible patients will then undergo biopsy to confirm the diagnosis of     recurrent malignant glioma. IL13-PE38QQR will be infused for 96 hours into and around tumor     tissue through catheters that have been placed surgically. For the first 48 hours the drug     will be mixed with a radioactive tracer, so that the distribution of the drug can be followed     by a type of scanning called SPECT. Surgery to remove the tumor will be performed     approximately 15 days after the end of the infusion. Catheters will again be placed     surgically, and IL13-PE38QQR will be infused a second time for 96 hours. Radioactive tracer     will be included in the infusion for the first 48 hours. For both infusions, SPECT scans will     be taken at 6, 24, and 48 hours after the start of infusion. MRI scans will be taken within     90 minutes of the 24 and 48 hour SPECT scans. Patients will be followed closely with further     scans and laboratory tests until completion of the study approximately 58 days after     completion of the second infusion.   "
170165|NCT00064792|"     This study will evaluate the safety and effectiveness of simvastatin in treating children     with Smith-Lemli-Opitz syndrome (SLOS). Patients with this inherited disease are deficient in     an enzyme that converts a substance called 7-dehydrocholesterol (7-DHC) to cholesterol.     Cholesterol synthesis is impaired, causing birth defects and mental retardation. This study     will examine whether simvastatin can increase the amount of the deficient enzyme, thereby     lowering 7-DHC and increasing cholesterol. It will examine the safety of simvastatin in     affected children and its effects on their behavioral problems.      Children between 4 and 18 years of age with mild to typical SLOS may be eligible for this     study. Participants will be evaluated at the NIH Clinical Center in Bethesda, MD, and at the     Kennedy Krieger Institute in Baltimore, MD, upon admission to the study and again at 6, 12,     20, and 26 months. The visits will last 3 to 4 days, and will include a medical history and     physical examination, photographs to document medical findings, and other procedures detailed     below. In addition, blood samples will be collected at 1, 3, 9, 14, 15, 17, and 23 months.     Parents will complete several questionnaires during the study. Procedures include the     following:        -  Simvastatin and cholesterol supplementation therapy. Patients take cholesterol          supplements (50 milligrams per kilogram per day) plus simvastatin (0.5 mg/kg/day for 6          weeks and then 1 mg/kg/day) for 12 months, and cholesterol supplements plus a placebo          for 12 months.        -  Blood draws to check liver, muscle, and kidney function, hormone levels, vitamin D          levels, blood counts, cholesterol and 7-DHC levels, and lipoprotein levels. Some extra          blood is drawn for research purposes.        -  Urine collection. Urine is collected using a toilet hat. For children who are not toilet          trained, urine is collected in a bag taped to the skin with an adhesive.        -  Electroretinogram (ERG) to measure the function of the retina, the light-sensitive          tissue at the back of the eye. ERG is done under sedation. After adapting the child's          eyes to the dark, an electrode is taped to the child's forehead, the surface of one eye          is numbed with eye drops, and a contact lens is placed on the eye. The child looks          inside a globe that emits a series of light flashes. The contact lens senses electrical          signals generated by the retina when the light flashes. After the ERG, the patient has a          full eye exam, including pupil dilation and photographs of the eye.        -  Lumbar puncture (spinal tap) to collect a sample of cerebral spinal fluid (CSF). This          procedure, done while the patient is sedated for the ERG, shows whether simvastatin          affects brain cholesterol and chemical levels. Under local anesthetic, a needle is          inserted in the space between the bones in the lower back where the CSF circulates below          the spinal cord. A small amount of fluid is collected through the needle.        -  CRH stimulation test to detect hormone-related problems in cholesterol synthesis. The          patient is given CRH, a hormone involved in cholesterol synthesis, through a plastic          tube placed in a vein. Blood samples are collected through the same catheter to measure          levels of other hormones involved in cholesterol production.        -  Electroencephalogram (EEG) to look at the electrical activity (brain waves) of the          child's brain.        -  Activity monitoring. An activity monitor, which looks like and is worn like a watch, is          used to record the child's level of activity for a 48-hour period.        -  Urine pregnancy test at every visit for female patients over age 10.        -  Skin swab for sterol (solid alcohol, such as cholesterol) analysis. An alcohol pad is          rubbed lightly against the child's arm or thigh to collect skin cells.        -  Stool collection. A small stool sample is collected from the child's diaper or, for          children who are toilet trained, from a toilet hat like that used to collect urine.   "
170166|NCT00064805|"     Adults who sustain brain damage due to stroke, head injury, or traumatic surgery may develop     difficulty reading. This study examines the effectiveness of behavior-based programs to     improve reading ability in these individuals.   "
170169|NCT00064844|"     The overall objective of the study is to develop recommendations for treatment programs to     help alcoholic smokers to stop smoking. A sample of 175 alcohol dependent cigarette smokers     will be recruited from the community and treated in a 6-month outpatient alcohol and tobacco     treatment program. The 175 patients will be divided into two groups. One group will receive     an active nicotine patch and active nicotine gum. The other group will receive an active     nicotine patch and placebo nicotine gum. Followup assessments will be conducted for 1-year     from the beginning of treatment.   "
170170|NCT00064857|"     The goal of this study is to evaluate the effectiveness of a standardized botanical extract     of Pycnogenol as a treatment for stable arm lymphedema in breast cancer survivors.   "
170171|NCT00064870|"     The purpose of the Alzheimer's Disease Genetics Study is to identify the genes that are     responsible for causing Alzheimer's Disease (AD). One of the ways in which the risk factor     genes for late onset AD can be investigated is by identifying and collecting genetic material     from families with multiple members diagnosed with AD or dementia.   "
170173|NCT00064896|"     The goal of this study is to develop advances in cardiovascular diagnostic and treatment     methods using magnetic resonance imaging (MRI), a test that uses a strong magnetic field and     radio waves to show anatomic detail. For the scan, the patient lies on a table in a cylinder     containing a magnetic field. He or she can communicate with a staff member at all times     during the procedure.      Patients 18 years of age or older who require 1) catheterization of the leg arteries for     diagnosis or treatment of blocked arteries, or 2) heart catheterization for diagnosis or     treatment of coronary artery disease or other heart problems may be eligible for this study.     Participants will undergo one of the following procedures:      Blood Flow Measurement Using Standard Techniques and MRI      For patients with blockage in a leg artery, blood flow will be measured before and after     successful catheter-based treatment (angioplasty or stenting) using standard venous occlusion     plethysmography and a newer MRI technique. (Patients whose treatment is not successful will     not undergo follow-up blood flow measurements in this study.) For venous occlusion     plethysmography, a large pressure cuff is placed around the upper or lower legs. Thin elastic     bands called a strain gauge are placed around the calves to measure blood blow to the legs.     The pressure cuffs are inflated for 5 minutes, preventing blood from flowing to the legs, and     are then deflated, allowing the blood to rush to the legs. A smaller cuff is inflated to a     low pressure, and the strain gauge measures this maximum blood flow to the legs for 1 or 2     more minutes. For the new MRI technique, blood flow is measured while the patient is in the     MRI scanner. Flow is first measured with the patient at rest. Then, the large pressure cuff     is inflated for 5 minutes. The cuff is deflated and additional images are taken. Before the     cuff is deflated, a dye called gadolinium contrast is injected into an arm vein to brighten     the images. Patients may undergo six to eight cuff inflations on four to six different days.      Fusion of X-Ray and MRI Images of Peripheral Arteries      For patients with blockage in a leg artery Participants will undergo catheterization and MRI     of the legs. Special plastic beads are taped to the leg(s) to help compare the MRI and x-ray     pictures. For the catheterization procedure, x-rays of the blood vessels are taken to guide     placement of the catheters. Contrast dye is injected to brighten the images of the blood     vessels. These injections work well in normal and partly blocked arteries, but not in     arteries that are completely blocked. For this study, patients first have an MRI scan of     their legs. During the scan, gadolinium contrast dye is injected into an arm vein. Then,     during the catheterization procedure, a computer aligns the MRI pictures with the x-ray     pictures to see if the combined images allow the doctor to better see where to place the     catheters.      Fusion of X-ray and MRI Images of the Heart      For patients undergoing heart catheterization will undergo MRI and heart catheterization.     Special plastic beads are taped to the chest to help compare the MRI and x-ray pictures.     Patients first have an MRI scan of their heart. During the scan, gadolinium contrast dye is     injected into an arm vein. Then, during the catheterization procedure, a computer aligns the     MRI pictures with the x-ray pictures to see if the combined images allow the doctor to learn     more about the pattern of heart disease.      Heart rhythm, blood pressure, heart function, and breathing will be monitored during all the     MRIs.   "
170174|NCT00064909|"     This study will use magnetic resonance imaging (MRI) to examine and compare changes in blood     flow and blood volume in the brains of normal volunteers and patients with multiple sclerosis     (MS). Patients with MS-an inflammatory disease that attacks the brain and spine-may have new     blood vessel formation (called angiogenesis) within the brain that may or may not contribute     to the disease or help in repairing the brain. It is not known if these new vessels behave in     the same way as the naturally occurring vessels. MRI uses a strong magnetic field and radio     waves to generate brain images that provide information on brain chemistry, function, and     blood flow. The results of this study may lead to a better understanding of MS.      Healthy normal volunteers and patients with multiple sclerosis 18 years of age and older may     be eligible for this study. Normal volunteers must have no history of signs or symptoms of     central nervous system disease. Patients with MS will be recruited from the NIH     Neuroimmunology MS clinic.      All participants will undergo MRI. For this procedure, the subject lies still on a table that     slides into a narrow metal cylinder (the MRI scanner). Scanning varies from 20 minutes to 3     hours, with most scans lasting between 45 and 90 minutes. During the scan, the subject wears     earplugs to muffle loud knocking noises caused by electrical switching of the radio frequency     circuits. The subject can communicate with the MRI staff at all times during the procedure.      During the scan, the subject wears a mask and breathes in room air or air containing 6%     carbon dioxide (CO2). (Room air contains approximately 0.04% CO2, which is about 150 times     less than the 6% CO2. Air that is normally breathed out contains about 5% CO2.) Breathing 6%     CO2 increases the amount of blood flow in the brain that can be measured using MRI. The total     duration of a single 6 percent CO2 inhalation will not exceed 10 minutes.      A catheter (thin plastic tube) is placed in a vein in the subject's arm before he or she     enters the scanner. At some point during the scan, a contrast agent called gadolinium DTPA is     injected into the vein through the catheter. This agent enables clearer images of the brain.   "
170175|NCT00064922|"     The purpose of this study is to examine the effects of incentive programs for the treatment     of nicotine dependence in women who have problems with substance dependence.   "
170176|NCT00064935|"     When a woman becomes pregnant, the fertilized egg attaches itself to the lining of the uterus     (endometrium). The endometrium is constantly changing throughout a woman’s menstrual cycle in     response to the female hormones estrogen and progesterone. The endometrium must have certain     characteristics (be at a specific phase in its cycle) in order for the fertilized egg to     successfully attach. Infertility may be caused by an out of phase endometrium (i.e., the     endometrium doesn’t have the right characteristics when the fertilized egg reaches it). The     purpose of this study is to evaluate whether the endometrial biopsy is useful in predicting     the potential for becoming pregnant and bearing a child.   "
170207|NCT00065364|"     Premature infants born between 28 and 33 weeks’ gestation often have significant brain     damage. Brain damage can be caused by the much greater stimulation the infant receives in the     neonatal intensive care unit (NICU) as compared to the mother’s womb. This study will test     the effectiveness of specialized and individualized NICU developmental care in preventing     brain damage.   "
170177|NCT00064961|"     This study addresses the high risk of weight gain associated with smoking cessation in women.     The obesity prevention pilot study is designed for the primary prevention of weight gain that     can lead to overweight in normal-weight women, that can progress to obesity in women who are     already overweight, and for the prevention of additional weight gain in obese women with BMI     greater than or equal to 30.0. Fat and other macronutrient intake, specifically, sugar,     complex carbohydrates, and protein, are analyzed as a target for individually tailored,     weight control intervention following smoking cessation in Caucasian and African American     women.   "
170178|NCT00064974|"     This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy     administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood     cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not     have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28     days of first day of study drug treatment. Subjects will receive study drug (CC-5013) in     28-day cycles for up to 6 cycles, or until bone marrow disease progression or     progression/relapse following erythroid hematologic improvement (Appendix I) is documented.     Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess     hematological parameters will occur every 14 days. Safety and efficacy assessments to be     performed during the study are outlined in the Schedule of Study Assessments.   "
170179|NCT00064987|"     Men with idiopathic hypogonadotropic hypogonadism (IHH, Kallmann Syndrome) may have small     testicular size, low testosterone levels, no history of puberty, and infertility. These men     lack a hormone called gonadotropin releasing hormone (GnRH) that stimulates the development     and maturation of the testes. This study will investigate the impact of hormonal treatments     on men with IHH. The goal of hormonal therapy is to maximize the potential fertility in these     individuals.   "
170180|NCT00065000|"     This is a 3-year pilot study funded by National Institute of Health will assess and evaluate     obesity-related health outcomes of a real-life policy decision, recently voted on and adopted     by the Seattle School Board.   "
170181|NCT00065013|"     We will assess whether undesirable loss of lean tissue following gastric bypass surgery for     obesity can be minimized by protein supplementation and exercise training.   "
170182|NCT00065026|"     Regular physical activity is important for good health. Women, particularly women with low     incomes, have many personal barriers to regular physical activity. The purpose of this study     is to reduce environmental barriers to physical activity for women in two specific low-income     neighborhoods (in Louisville, KY) by providing opportunities for safe physical activity and     addressing barriers such as lack of child care. Two groups of women will have pretest     information (cholesterol, blood sugar, blood pressure, percent body fat, height, weight,     waist and hip measurements) collected and the same information 6 months later at post-test.     One group will have access to multiple physical activity opportunities in their neighborhood     and at the neighborhood community center. An advanced registered nurse practitioner will     facilitate the activity opportunities. The groups will be compared on their pretest and     post-test information to see if the group with the physical activity opportunities has     increased physical activity as measured by pedometer and self-report questionnaire, and to     see if there are changes in the measures tested at pre and post (measures that may be     improved by regular physical activity).   "
170183|NCT00065039|"     The study will be conducted in four Catholic schools with children enrolled in Grades 2     through 6. Girls and boys and children of all racial types are eligible for participation in     the study. We anticipate that approximately 1,000 to 1200 children will volunteer for the     study. We request enrollment of 1200 children. To participate, parents must grant written     consent and the child must assent by signing a consent form that is attached. Two of the four     schools that volunteer for participation in the study and are approved by the research team,     will be randomly assigned to a health promotion program called Wise Mind for Diet and     Physical Activity. The other two schools will be randomly assigned to a program called Wise     Mind for Avoidance of Alcohol, Drugs, and Tobacco. Students will receive the program in the     school that they attend. They will not be allowed to select one of the programs and will     receive only one program, i.e., the program in their school. Both health promotion programs     will last for two academic years. Each year, every child that is a research participant will     be tested on two occasions, once during the first two months of school (Sept and Oct), and     once during the last two months of school (March and April). Testing will not be conducted     during May in order to avoid interference with school activities at the end of the academic     year. All children (in all four schools) will have the same testing. The testing will involve     confidential measurement of eating habits, food intake, physical activity habits, attitudes     about alcohol, drugs, and tobacco, body weight and height, body fatness, body image, mood,     and self-esteem. The measurement techniques that will be used for this measurement will     include: questionnaires, weighing, measurement of height, and photography of foods before and     after eating. All measurements will be confidential and will not be released to anyone that     is not involved in the management of the study, including school personnel. The total time     requirement for each testing period is expected to be approximately three hours, spread over     four testing periods during a two-week period. The testing periods will be conducted in     conjunction with school administrators and will not be scheduled to conflict with important     school activities, classes, or academic tests. A Data and Safety Monitoring Board (DSMB) will     be organized to provide oversight for the conduct of the study.   "
170184|NCT00065052|"     The purpose of this study is to determine if limiting television (TV) and computer time will     result in a stabilization or smaller increase in body mass index (BMI), lower energy intake,     and increased physical activity in 4-7 year old obese (>85th BMI percentile) children over     two years.   "
170185|NCT00065065|"     This is a multicenter, randomized, double-blind, placebo-controlled study evaluating     rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks.     The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the     treatment of mild to moderately active ulcerative colitis. Disease activity will be measured     using a standard disease activity index. Calculation of the index requires patients to     undergo flexible sigmoidoscopy at the start of the study and at week 12.   "
170186|NCT00065078|"     This study will evaluate a program that provides birth control to low income and minority     women through home visits by a community health nurse. The goal of the program is to reduce     unwanted pregnancies.   "
170187|NCT00065104|"     This study's purpose is to learn how dehydroepiandrosterone (DHEA) affects the HIV virus, the     immune system, hormone levels, body composition and quality of life.   "
170188|NCT00065117|"     The purpose of this study is to assess the Safety, Tolerability and Efficacy of ZD6126 in     Combination with Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects with Metastatic     Colorectal Cancer.   "
170189|NCT00065130|"     This trial is conducted in the United States of America (USA). The purpose of this study is     to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to     regular human insulin for the control of blood glucose after meals in women who develop     diabetes during pregnancy.   "
179019|NCT00189761|"     A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation     (MR4) in de novo bone marrow transplant recipients   "
170191|NCT00065156|"     This study is a multicenter, single-arm, open-label study of oral lenalidomide monotherapy     administered to red blood cell (RBC) transfusion-dependent subjects with low- or     intermediate-1-risk Myelodysplastic Syndromes (MDS) associated with a del (5q31-33)     cytogenetic abnormality. Screening procedures will take place within 28 days of the first day     of lenalidomide treatment. Subjects will receive lenalidomide in 28-day cycles for up to 6     cycles, or until bone marrow disease progression or progression/relapse following erythroid     hematologic improvement is documented. Study visits will occur every cycle (every 28 days)     and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety     and efficacy assessments to be performed during the study are outlined in the Schedule of     Study Assessments.   "
170192|NCT00065169|"     The purpose of this study is to determine whether the anti-inflammatory drug celecoxib can     delay the onset of Alzheimer Disease (AD) in people with Age Associated Memory Impairment     (AAMI). This study will also evaluate genetic risk and brain structure as potential     predictors of mental decline.   "
170193|NCT00065182|"     The purpose of this study is to compare the efficacy and safety of a weekly regimen of two     FDA approved drugs in combination versus one FDA approved drug in subjects with advanced     non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or     HYCAMTIN.   "
170194|NCT00065195|"     The purpose of this study is to determine whether massage therapy is effective in reducing     pain and distress and improving quality of life among cancer patients at life's end.   "
170195|NCT00065208|"     The purpose of this study is to determine whether Reiki energy healing affects anxiety and     disease progression in patients with localized prostate cancer who are candidates for radical     prostatectomy.   "
170196|NCT00065221|"     This is a trial to determine the safety and efficacy of ginger in reducing the prevalence and     severity of chemotherapy induced nausea and vomiting.   "
170197|NCT00065234|"     The purpose of this study is to determine if acupuncture is effective in preventing prolonged     postoperative paralysis of the gastrointestinal tract among patients undergoing     colostomy/ileostomy closure.   "
170199|NCT00065260|"     Severe aplastic anemia, characterized by pancytopenia and a hypocellular bone marrow, is     effectively treated by immunosuppressive therapy, usually a combination of antithymocyte     globulin (ATG) and cyclosporine (CsA). Survival rates following this regimen are equivalent     to those achieved with allogeneic stem cells transplantation. However, approximately 1/3 of     patients will not show blood count improvement after ATG/CsA. General experience and small     pilot studies have suggested that such patients may benefit from further immunosuppression.     Furthermore, analysis of our own clinical data suggest that patients with poor blood count     responses to a single course of ATG, even when transfusion-independence is achieved, have a     markedly worse prognosis than patients with robust hematologic improvement. The management of     such cases is uncertain.      This study will enroll patients who are either refractory to h-ATG (continued severe     pancytopenia) or who have only modest improvement in blood counts (weak hematologic     responders) to receive a further immunosuppressive therapy, delivered either as rabbit ATG     (Thymoglobulin, r-ATG) or a humanized monoclonal antibody to T-cells, alemtuzumab (Campath-1H     ). Primary endpoint will be response rate at 3 months defined as no longer meeting criteria     for severe aplastic anemia. Relapse, robustness of hematopoietic recovery at 3 months,     survival and clonal evolution to paroxysmal nocturnal hemoglobinuria (PNH), myelodysplasia     and acute leukemia will be the secondary endpoints.   "
170200|NCT00065273|"     Psychiatric drugs are often used to treat behavioral symptoms of mental     retardation/developmental delay (MR/DD). These drugs can cause serious side effects. Newer     drugs may have decreased side effects. This study will compare new and old drugs used to     treat behavioral symptoms in people with MR/DD.   "
170201|NCT00065286|"     Akathisia is a movement disorder that is often a side effect of certain psychiatric drugs.     People with akathisia are unable to sit or keep still, complain of restlessness, fidget, rock     from foot to foot, and pace. Akathisia is sometimes called “restless legs syndrome.” The     drugs that can cause akathisia are most often used to treat patients with schizophrenia or     mental retardation (MR). This study will evaluate akathisia in both schizophrenic and MR     patients who either have long-term akathisia or who are starting treatment with psychiatric     drugs.   "
170202|NCT00065299|"     Phenylketonuria (PKU) is a rare genetic condition. If not treated, PKU can cause severe     mental retardation. Women with PKU are advised to eat a special diet when pregnant to prevent     mental retardation in their children. This study will evaluate the effects of that diet on     the children of mothers with PKU.   "
170203|NCT00065312|"     The purpose of this study is to determine if an investigational drug is safe and efficacious     for poorly controlled type 2 diabetes mellitus.   "
170204|NCT00065325|"     The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin     (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer.     Patients will be treated until disease progression or until the investigator has determined     that treatment is not in the best interest of the patient, whichever occurs first.   "
170205|NCT00065338|"     These studies will provide us with enormous insight regarding how obese patients adapt     energetically during negative energy balance. We will gain fundamental information regarding     the metabolic implications of combining food restriction with a walking program compatible to     that advocated by statutory agencies. These studies will lead to improved understanding of     the energetic adaptation that occurs during negative energy balance and how best to treat     patients with obesity.   "
170206|NCT00065351|"     For each subject the study will consist of two phases: a treatment phase and a follow-up     phase. Screening procedures will take place within 28 days of baseline.      Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent     CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma     paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every     4 weeks thereafter.      Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will     continue to be followed for survival and post-treatment phase anti-myeloma treatment.   "
170208|NCT00065377|"     This study will examine whether glucosamine affects the way the body responds to insulin.     Insulin is a hormone that causes the body to use glucose (sugar). Insulin does not work as     well in overweight people, causing a condition called insulin resistance. Insulin also     increases the flow of blood into muscle by opening inactive blood vessels. This study will     test whether glucosamine, a nutritional supplement that many people take to treat arthritis,     can cause or worsen insulin resistance or change how blood vessels react to insulin in normal     weight and overweight people.      Healthy normal weight and overweight volunteers between 21 and 65 years of age may be     eligible for this study. Candidates will be screened with a brief physical examination,     medical history, and blood and urine tests. After screening, participants will have three     additional outpatient clinic visits for the following procedures:      Visit 1        -  Glucose clamp test to measure the body's response to insulin: For this procedure, a          needle is placed in a vein of each arm, one for drawing blood samples, and one for          infusing glucose and a potassium solution. The glucose is infused continuously during          this 4-hour test and blood is drawn frequently to monitor glucose and insulin levels.          After the test, blood glucose levels are monitored for another 2 hours to make sure they          remain at an adequate level to prevent hypoglycemia (low blood sugar).        -  Blood flow measurement: Blood flow in the brachial artery of the arm is measured to          assess how many capillaries (very small blood vessels) are being used to supply          nutrients and oxygen to the muscle in the forearm. This test is done at the same time as          the glucose clamp test. Blood flow is measured using a technique called contrast          ultrasound. A small amount of contrast agent consisting of gas-filled bubbles the size          of red blood cells is infused over 10 minutes through one of the catheters placed in the          vein for the glucose clamp test. The contrast agent is infused twice, once at the          beginning of the glucose clamp test and once at the end of the test. The contrast          material creates a signal in response to ultrasound that provides information about the          distribution of capillaries in the forearm.        -  Assignment to medication group: Participants are randomly assigned to take either          glucosamine or placebo three times a day by mouth for 6 weeks. At the end of the 6          weeks, no study drug is taken for 1 week, and then participants cross-over          medications, those who took glucosamine for the first 6 weeks take placebo for the next          6 weeks and vice versa.      Visits 2 and 3      For these visits, the glucose clamp test and blood flow measurements are repeated. Visit 2 is     scheduled at the end of the first 6-week treatment period, and Visit 3 is scheduled at the     end of the second 6-week treatment period.   "
170209|NCT00065390|"     This study will examine whether the drug pyrimethamine can shrink lymph nodes and spleen in     patients with autoimmune lymphoproliferative syndrome (ALPS). In this disease, lymphocytes     (white blood cells) do not die as they normally would. As a result, patients have enlarged     lymph glands, spleen, or liver, and other problems that may involve blood cell counts and     autoimmune disease (overactivity of the immune system). Pyrimethamine is an orally     administered antibiotic that has been used to treat or prevent malaria and toxoplasma, and     may be effective in shrinking lymph nodes and spleen.      Patients with ALPS who are between 2 and 70 years of age and have had lymph gland enlargement     for at least 1 year may be eligible for this study. Candidates will be screened with a     medical history and physical examination, blood tests, and possibly a bone marrow test.     Females of reproductive age will be screened with a urine pregnancy test. Women who are     capable of becoming pregnant must use an effective method of birth control during the entire     study period, because, taken during early months of pregnancy, pyrimethamine can cause birth     defects in the fetus. Women who are pregnant or nursing are excluded from the study.      Participants will undergo the following tests and procedures:        -  CT scan: For this test, the patient lies still in the CT scanner while images are taken          of the neck, chest, and stomach area. A contrast dye is injected into a vein to brighten          the CT images. Very young children will be evaluated on a case by case basis to          determine whether a CT scan will be performed.        -  Bone marrow biopsy: Participants undergo this test to rule out underlying bone marrow          disease if they have not had a bone marrow test done in the last six months prior to          enrolling in pyrimethamine study, as pyrimethamine can affect bone marrow function.          Under local anesthesia, a needle is inserted into the back part of the hipbone and a          small amount of marrow is removed. (Children are sedated for this test.)        -  Leukapheresis: This is a procedure for collecting a small proportion of circulating          white blood cells while conserving the majority of blood cells. Specifically, blood is          drawn from a needle placed in an arm vein and is directed into a cell separator machine,          which separates the blood cells by spinning. A small proportion of circulating white          cells are removed, and the red cells, platelets, plasma and majority of white cells are          returned to the patient's blood circulation. Only patients who are 7 years of age or          older and weigh at least 55 pounds undergo this procedure. Other participants who choose          not to have apheresis will have about 3 tablespoons of blood drawn instead.        -  Pyrimethamine administration: When the above tests are completed, participants begin          taking pyrimethamine. The dose is determined according to the individual's weight and is          gradually increased during the study period. Patients take the drug twice a week for a          total of 12 weeks.        -  Blood tests: Blood samples are collected during weeks 2, 4, 6, 8, and 10 after beginning          treatment, and 2 weeks after the last dose of pyrimethamine. The purpose of these blood          tests is to check for possible drug-related side effects. Patients who develop a skin          rash, mouth sores or other side effects may have one or more doses of the treatment drug          withheld. When indicated, the patient will be directed to stop taking the study drug. If          needed, drug side effects will be treated with a vitamin supplement, folinic acid, taken          by mouth, 3 times weekly.        -  Evaluations at the NIH Clinical Center will comprise of a pretreatment visit, one end of          treatment visit at the end of 12 weeks and an optional post-treatment visit 3months          after stopping pyrimethamine therapy.      Patients who respond well to treatment may be asked to return to NIH for additional visits at     3, 6, and 12 months after the treatment has ended for repeat evaluations. If their lymph     glands or spleen become much larger after stopping pyrimethamine, they will be offered     treatment for another 12 weeks. If they respond to the second course of treatment, they will     return to NIH again after 3, 6, and 12 months. If the symptoms return again, patients will be     asked to resume treatment for an additional 6 months or more. They will have blood drawn     periodically by their private physician and will return to NIH for evaluation every 12 weeks.   "
170210|NCT00065403|"     Little is known about acupuncture's efficacy for Irritable Bowel Syndrome (IBS). This trial     uses a manualized acupuncture treatment format that closely follows clinical practice and     allows flexibility in designing individualized treatments. In addition, a second parallel     qualitative study will follow a subgroup of patients throughout the trial to explore the     relationships between patients' interpretations and understandings (what anthropologists call     meaning) of irritable bowel and their response to treatment. Cortisol levels (an important     stress hormone) will also be assessed.      This will be a 3-arm trial: Active acupuncture, placebo acupuncture, and wait list.   "
170211|NCT00065416|"     This study will provide the basis for a full-scale trial to evaluate the effectiveness and     safety of therapeutic massage for chronic neck pain (CNP).   "
170213|NCT00065442|"     Provenge is an investigational product designed to activate a man's own antigen presenting     cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an     immune response against them.      Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level.     One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase     3 study.      If you decide to participate and are eligible, you will be enrolled in the study and randomly     assigned to receive either active product or placebo. There are two chances in three that you     will receive Provenge. After receiving treatment, you will be monitored at regular intervals     until the study endpoints are met. At the end of the trial, men who received placebo will     have the opportunity to be treated with active product in another study.   "
170214|NCT00065455|"     Retinitis pigmentosa (RP) is a collective term for a group of inherited retinal dystrophies     that are a major cause of irreversible blindness. RP of some type occurs in approximately 1     out of 3500 persons in the United States(1). Gene mutations are responsible for the majority     of RP. To date, mutations have been identified in 30 different genes linked to RP(2). The     visual prognosis of RP is poor, since the gradual but relentless visual field loss leads     eventually to some degree of blindness(3). Although no effective treatment for RP has been     identified, participants supplemented with a daily oral dose of 15,000 IU vitamin A palmitate     have shown, on average, a slower rate of deterioration of retinal function when the     intervention is continued over several years(4). The purpose of this research is to determine     whether administration of high oral doses of vitamin A can acutely improve cone photoreceptor     function in RP participants as measured by electroretinography (ERG). In this interventional,     non-randomized, prospective, pilot study, 5 participants will receive a daily oral dose of     50,000 IU of vitamin A palmitate for 4 weeks, followed by a maintenance dose of 15,000 IU     daily for the subsequent 2 weeks. The primary efficacy outcome is a relative percentage     change in ERG response amplitude subsequent to vitamin A supplementation. A secondary     efficacy outcome is a relative percentage change in implicit time from pre- to post- vitamin     A supplementation, with improvement specified as a shorter response implicit time. Other     secondary outcomes will be improvements in visual field (Humphery, 10-2; sum of thresholds).     Safety outcomes include visual fields, ETDRS visual acuity, intraocular pressure, serum     vitamin A level and liver function tests.   "
170215|NCT00065468|"     The primary objective of this study is efficacy. The primary efficacy endpoint of this study     is a comparison of the overall survival of subjects treated with CCI-779 [Temsirolimus],     administered intravenously [IV] once weekly and the combination of CCI-779, administered IV     once weekly with Interferon Alfa [IFN alfa] subcutaneously [SC] three times per week [TIW],     compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in     poor-prognosis subjects with advanced RCC.   "
170216|NCT00065507|"     This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg     QD in patients who have chronic hepatitis B infection and hepatic decompensation. The     patients are treated for 96 weeks after the last subject is randomized.   "
170217|NCT00065533|"     The purposes of this study are to determine the safety of pemetrexed and any side effects     that might be associated with it, whether pemetrexed can help patients with breast cancer and     how much pemetrexed should be given to patients.   "
170218|NCT00065546|"     The purpose of this study is to increase our understanding of how much choline humans need to     get from their diet. Choline is an essential nutrient found in many foods, including eggs and     milk. In addition to dietary sources, choline can be made in the liver. Choline is important     in making membranes or wrappers for all the cells in the body and for making chemicals that     allow nerve cells to work properly. In a previous study we found that the dietary requirement     for choline varies greatly from person to person. This was caused, in part, by how much     estrogen a person has and their genetic makeup. We are conducting this study to explore how     estrogen levels and specific differences in genes influence choline requirements so that we     can refine the dietary recommendations for this nutrient.   "
170219|NCT00065559|"     COX-2 is an enzyme that is found in several different tissues in the body. COX-2 appears to     produce a substance called prostaglandins, mainly at sites of inflammation. Several drugs     have been approved by the FDA that inhibit COX-2 such as celecoxib, or brand name Celebrex®.     These drugs are primarily used in patients with osteoarthritis and rheumatoid arthritis to     decrease inflammation and pain. COX-2 inhibitors have been developed because they are more     selective in treatment of inflammation and pain and tend to have fewer gastrointestinal side     effects than NSAIDs (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen,     naproxen, etc.      The normal adult kidney expresses COX-2 in various regions. Prostaglandins, which are     produced in the kidney by COX-2, may contribute to glomerular and tubulointerstitial     inflammatory diseases (types of kidney diseases due to inflammation). In some animal studies,     COX-2 inhibitors have been shown to be potentially beneficial in reducing the amount of     protein spilled in the urine and preserving kidney function with these inflammatory kidney     diseases. This study will compare the effects of COX-2 inhibitor to placebo (an inactive     substance) in patients with diabetic nephropathy (kidney disease due to diabetes) and     proteinuria (spilling protein in the urine) on 24-hour urinary protein excretion.      This study is designed to see whether COX-2 inhibitors are useful in treating diabetic     patients with kidney disease. The purpose of this study is a short-term pilot study that will     allow the gathering of important data such as the ability to carry out the study and carry it     out safely. Subjects with proteinuria and diabetic kidney disease already on ACE     (Angiotensin-Converting Enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) therapy     (types of blood pressure medicines) will be randomized to a type of study in which each     subject will serve as their own control. The study is set up so that each subject will     receive either the COX-2 inhibitor or placebo for a period followed by a period of no drug     and then followed by a period of receiving either the COX-2 inhibitor or placebo (whichever     they did not receive the first period).   "
170220|NCT00065572|"     The purpose of this study is to assess the biological activity of ZD6126 in subjects with     newly diagnosed metastatic renal cell carcinoma (stage IV).   "
170221|NCT00065585|"     This is a trial to clarify the extent to which acupuncture needling can diminish the effect     of chronic back pain on patient functioning and symptoms.   "
170222|NCT00065611|"     Focal segmental glomerulosclerosis (FSGS) and minimal change disease are kidney diseases that     are associated with increased excretion of protein in the urine. Approximately half of FSGS     patients will lose kidney function within 8 years of diagnosis and will require dialysis. The     purpose of this study is to determine whether intermittent oral steroid therapy can cause     sustained remission of FSGS and MCD.      Approximately 70 participants, including adults and children older than age 2, will be     enrolled in this study. They will receive 48 doses of oral dexamethasone over a period of 48     weeks. One group will take two daily doses every 2 weeks; the other group will take four     daily doses every 4 weeks. Doctors will monitor participants before, during, and after the     steroid treatment with extensive exams and testing. At the completion of the study,     researchers will evaluate the safety and efficacy of the drug treatment.   "
170223|NCT00065624|"     The goal of this study is to determine whether a short treatment with lipoic acid, an     antioxidant used in the treatment of diabetic neuropathy, improves blood vessel reactivity     and decreases oxidant stress in persons with elevated blood cholesterol.   "
170224|NCT00065637|"     Daily parathyroid hormone (PTH) is approved by the FDA for the treatment of osteoporosis.     This study will evaluate the safety and effectiveness of PTH when given once a week.   "
170225|NCT00065650|"     The purpose of this study is to determine the feasibility and effectiveness of a     multimodality Vedic Medicine treatment protocol for the management of newly diagnosed type 2     diabetes.   "
170226|NCT00065663|"     Patients with diabetes may develop chronic wounds that respond poorly to treatment. Gene     therapy with the platelet-derived growth factor-B gene has been shown to help with the     healing of chronic wounds. This study will evaluate a new way to deliver the gene to the     wound tissue.   "
170227|NCT00065676|"     Quercetin is a compound naturally found in various foods. It may have some role in the     treatment of obesity and diabetes.      The purpose of this study is to investigate research volunteers with obesity or obesity with     type 2 diabetes to determine whether quercetin affects the way glucose is absorbed by the     body.      Thirty two participants aged 19 to 65 who are considered to be medically obese or obese with     type 2 diabetes will be enrolled in this study. Before the onset of treatment, they will     undergo a medical history, physical exam, blood work, and urinalysis. During the study,     participants will be given an oral glucose tolerance test three times; during these tests     they will receive 1 or 2 grams of quercetin, or placebo. Researchers will collect blood     samples and analyze the effect of the treatment on blood glucose.   "
170228|NCT00065689|"     The purpose of this study is to determine whether bright light improves the sleep, mood, and     behavior of persons with Alzheimer's disease and related dementias (AD) who live in long-term     care settings and, if so, to determine the best timing for the light therapy. The light     levels being used in the study have been shown to improve depression in persons with seasonal     affective disorder (SAD) and to relieve sleep problems in persons with jet lag and other body     rhythm disturbances. Because persons with AD often will not remain still in front of a     fluorescent panel, this project has involved renovations in the study units that provide for     even, regulated, high-intensity light in all public areas of the study settings.   "
170229|NCT00065702|"     The purpose of this study is to evaluate the efficacy of individualized classical homeopathy     in treatment of persons with fibromyalgia and to determine the usefulness of     electroencephalographic and electrocardiographic measures to serve as markers of differences     between active and placebo treatment.   "
170230|NCT00065715|"     The design and interpretation of randomized trials is intimately connected to the use of     placebo. The nature and magnitude of placebo effects, however, is very poorly understood.     This study will assess and compare placebo effects and physician interaction effects within a     community-acquired common cold model. The goal of this study is to assess two kinds of     placebo affects and how physician interaction effects;        1. The effect of receiving blinded placebo, compared to no treatment; and        2. The effect of receiving open-label active Echinacea treatment compared to blinded active          treatment.   "
170231|NCT00065728|"     The purpose of this study is to investigate the long-term efficacy and safety of posterior     juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.   "
170232|NCT00065741|"     A series of clinical studies will be conducted in normal, healthy adult volunteers to     evaluate the potential for alterations in the pharmacokinetics of anti HIV drugs when     botanicals/nutriceuticals are given concurrently via the oral route. Both the drugs and     botanicals are known to rely upon or to modulate, respectively, metabolism via     glucuronidation.   "
170233|NCT00065754|"     This study examines the mechanisms, including brain imaging of placebo analgesia   "
179020|NCT00189774|"     The purpose of this study is to investigate the superiority of nateglinide over placebo for     inadequately controlled type 2 diabetic patients with pioglitazone treatment.   "
170234|NCT00065767|"     The aim of this study is to determine the effectiveness of treatment with raloxifene, an     estrogen-like medication approved by the Food and Drug Administration for the treatment of     osteoporosis, in improving memory and the ability to live independently in postmenopausal     women with Alzheimer's disease.   "
170235|NCT00065780|"     To rescan 6,700 subjects in the MESA study to obtain computed tomography measures of     calcification.   "
170236|NCT00065793|"     To evaluate very low density lipoprotein (VLDL) and low density lipoprotein (LDL) particle     types as predictors of initial coronary events.   "
170237|NCT00065806|"     The purpose of this study is:        1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of          atherosclerosis that predisposes children with SLE to cardiovascular events in          adulthood.        2. To assess the safety of intermediate-term (36 months) treatment of children and young          adults with atorvastatin.        3. To further characterize the course of SLE in children and young adults, by establishing          a cohort of pediatric SLE patients to be followed prospectively.        4. To establish a mechanism for conducting clinical trials in rare pediatric rheumatic          diseases using the Children's Arthritis and Rheumatology Research Alliance (CARRA).   "
170238|NCT00065819|"     African American mothers infected with HIV face unique challenges in management of their     disease. The goal of this study was to determine the effectiveness of an HIV self-care and     symptom management program designed to help low-income African American mothers with HIV.   "
170239|NCT00065832|"     The first line of defense against reading disabilities is good classroom reading instruction.     This study describes how characteristics of students, teachers, and instruction relate to     academic achievement in inner-city kindergarten through Grade 4 classrooms.   "
170240|NCT00065845|"     Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or     bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can     be corrected with surgery. However, women who have this surgery may develop urinary     incontinence. This study will determine how doctors can predict this problem and whether an     additional surgical procedure at the time of prolapse surgery can prevent the development of     urinary incontinence.   "
196306|NCT00419068|"     The purpose of this study is to determine whether vitamin D enhances response to standard     antibiotic treatment for pulmonary tuberculosis.   "
170241|NCT00065858|"     BufferGel is a new contraceptive gel designed to be used with a diaphragm. In addition to     preventing pregnancy, BufferGel may also prevent some types of sexually transmitted diseases     (STDs). This study will compare BufferGel to Gynol II, a currently available contraceptive     gel.   "
170242|NCT00065871|"     Hormonal birth control methods include birth control pills, patches, and vaginal rings; they     are normally available only with a doctor’s prescription. This study will evaluate a program     designed to increase the availability of birth control by allowing pharmacists to give women     hormonal birth control without a doctor’s prescription. Under this program, pharmacists will     evaluate women who want to use birth control according to specific guidelines created by     doctors. If a woman meets the criteria in the guidelines, a pharmacist could then give her     the appropriate form of hormonal birth control.   "
170243|NCT00065884|"     This study will examine the effect of valproate, a medication used to treat seizures and     bipolar disorder, on aggressive behavior in children and adolescents with autism.   "
170244|NCT00065897|"     Prenatal diagnosis can provide information to parents about specific fetal disorders.     However, invasive prenatal diagnostic procedures are associated with risks to the fetus. This     study will compare the safety and effectiveness of two methods of invasive prenatal     diagnosis: amniocentesis and transabdominal chorionic villus sampling (TA CVS).   "
170245|NCT00065910|"     Toddlers with autism have poor joint attention skills. Joint attention skills include     pointing to objects, following another person’s gaze, and responding to invitations to join     in a social interaction. Improved joint attention skills may lead to better verbal ability as     the child ages. This study teaches caregivers how to help their toddlers with autism develop     joint attention skills.   "
170246|NCT00065923|"     Prader-Willi syndrome (PWS) is a genetic disorder usually caused by the deletion of a     specific gene. One of the symptoms of PWS is self-injurious behavior (SIB); a common form of     SIB in PWS patients is skin picking. The injury may be severe enough to require frequent     medical attention. This trial will evaluate SIB in individuals with PWS and will test the     effectiveness of the drug topiramate to control SIB.   "
170247|NCT00065936|"     Self-injurious behavior is behavior in which a person hurts or harms himself. This behavior     sometimes occurs in people with mental retardation or autism. This study will evaluate     self-injurious behavior in people with mental retardation or autism and will test the     effectiveness of new treatments.   "
170248|NCT00065949|"     Premature infants are at risk for acute brain injuries and long-term developmental problems     such as cerebral palsy (CP). Research suggests that high levels of magnesium at and around     the time of birth may decrease the risk of brain injuries. This study will evaluate the     effects of giving magnesium to premature infants.   "
170249|NCT00065962|"     Many drugs used to treat autism target specific symptoms, such as hyperactivity and     aggressiveness. Few drugs target the core autistic symptoms of impaired social interaction     and communication. This study will evaluate two forms of the drug secretin for the treatment     of core autistic symptoms.   "
170250|NCT00065975|"     This is a pilot randomized trial intended to evaluate the effectiveness of acupuncture,     chiropractic and massage for chronic back pain in older and younger adults.   "
170251|NCT00065988|"     The Children's Amalgam Trial is one of only two randomized trials of its kind, and the only     such trial in the United States, to address the potential impact of mercury exposure from     amalgam restorations on neuropsychological and renal function in children.   "
170252|NCT00066001|"     The purpose of this study is to determine the clinical and microbiological effects of     systemically administered metronidazole alone or in combination with professional plaque     removal on periodontally diseased patients.   "
170253|NCT00066014|"     The purpose of this study is to compare the effectiveness of three variable dental implant     attachment methodologies in conjunction with lower dental-implant retained/supported complete     overdenture treatment. These three methods are all presently used by dental practitioners,     but vary significantly in terms of added treatment cost and complexity. The study tests the     hypothesis that the least complex and costly method provides an equivalent treatment outcome     to other more complex and costly methods.   "
170255|NCT00066040|"     The purpose of this study is to control the levels of bacteria that causes cavities in     mothers by a combination of treatments that include fluoride and chlorhexidine varnishes and     xylitol-chewing gum before the appearance of teeth in the mouth of their children. By doing     that we expect to reduce the acquisition of the bacteria that causes cavities (the mutans     streptococci) by the children which in turn will reduce the development of cavities.   "
170256|NCT00066053|"     The purpose of this study is to determine if treating periodontal infections (gum problems)     will lead to fewer heart problems in patients at high risk for cardiovascular disease.   "
170257|NCT00066066|"     The purpose of this study is to determine in current and non-smokers the clinical and     microbiological effects of 3 therapies: scaling and root planing (SRP) alone; SRP in     combination with the orally administered antibiotic metronidazole; and SRP with the orally     administered antibiotics metronidazole and amoxicillin along with the locally delivered     antibiotic doxycycline at periodontal pockets >= 4 mm.   "
170258|NCT00066079|"     The purpose of this study is to compare the effects of in-home, family-administered massage     and in-home relaxation training on measures of physical status and health care utilization in     a sample of African American adolescents age 15 years and older and adults with chronic pain     associated with sickle cell disease who have been randomly assigned to six sessions of either     family-administered massage or progressive muscle relaxation training.   "
170259|NCT00066092|"     This is a randomized, double-blind, multi-center study to assess the safety and effectiveness     of using a single subcutaneous (under the skin) injection of pegfilgrastim or daily     subcutaneous injections of Filgrastim to mobilize stem cells for autologous transplantation     in patients with Hodgkin's or non-Hodgkin's lymphoma.   "
170260|NCT00066118|"     The purpose of this study is to determine whether there are detectable health effects of     low-level mercury exposure (from normal exposure to mercury-containing dental fillings) in     the known target organs/systems affected by elemental mercury exposure.   "
170261|NCT00066131|"     The purpose of this study is to determine if non-surgical periodontal (gum) treatment can     reduce the incidence of preterm birth and low birth weight babies in mothers with     periodontitis (gum disease).   "
170262|NCT00066144|"     This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the     efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also     assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies),     breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline     and 1 year.   "
170263|NCT00066157|"     This is a 15-month study to determine the effectiveness of hormone replacement therapy in     improving memory and the ability to live independently in postmenopausal women with     Alzheimer's disease.   "
170264|NCT00066170|"     This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled,     parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be     required to make 5 visits over up to 14 weeks to a participating expert physician     practitioner for various sleep and narcolepsy evaluations and diaries will also be collected.     Participants will take assigned medications during the course of the trial. Subjects will     have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject     volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness.     Patients will not incur any personal medical expenses due to participation in this trial. The     sponsor is covering all visit costs not covered by insurance and there are some funds for     patient expenses such as travel.   "
170265|NCT00066183|"     Phosphorus and phosphate irons play critical roles in bone structure and essential cellular     functions.      The purpose of this study is to learn more about the factors and hormones that regulate     phosphorus in the body by collecting blood and urine samples from patients with disorders of     phosphate control.      Both children and adults will be enrolled in this study. Researchers will collect blood and     urine samples from participants on multiple occasions (2 to 6 times). Some blood specimens     will be taken after an overnight fast and participants may be asked to collect all their     urine during a 24-hour period. Researchers will analyze these blood and urine samples to     better understanding how the body handles phosphorus.   "
170266|NCT00066196|"     The primary objectives of this study are:        -  To explore the antitumor activity of MEDI-522 ± DTIC in patients with metastatic          melanoma.        -  To determine the safety of MEDI-522 ± DTIC in this patient population.   "
170267|NCT00066209|"     Severe Acute Respiratory Syndrome (SARS) is a newly recognized illness that can be fatal.      The purpose of this study is to better understand SARS by collecting samples of blood and     other body fluids of people who have been exposed to SARS or who are suspected to have the     illness.      Up to 300 volunteers aged 18 years or older will be enrolled in this study. Participants will     donate blood samples and, if appropriate, samples of fluid from the lungs, nose, or throat.     Researchers will test these samples for proteins that control or mediate inflammatory or     immune responses. The patterns of these proteins will reveal how SARS affects the body and     the efforts the body makes to fight off the infection.   "
170268|NCT00066222|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together     with radiation therapy works in treating patients with limited-stage small cell lung cancer.   "
170269|NCT00066248|"     RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in     children with cancer.      PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in     improving appetite and preventing weight loss in children with cachexia caused by cancer or     cancer treatment.   "
170270|NCT00066274|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Giving the drugs in different combinations may kill more tumor     cells.      PURPOSE: This randomized phase II trial is studying combination chemotherapy containing     irinotecan and oxaliplatin to see how well it works compared to two standard combination     chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.   "
179021|NCT00189787|"     This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.   "
170271|NCT00066313|"     RATIONALE: ZD6474 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. ZD6474 may also stop the growth of small cell lung cancer by blocking blood     flow to the tumor.      PURPOSE: This randomized phase II trial is studying how well ZD6474 works compared to placebo     in treating patients with small cell lung cancer that has responded to previous chemotherapy     with or without radiation therapy.   "
170272|NCT00066326|"     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes     necessary for cancer cell growth. Drugs used in chemotherapy such as     17-N-allylamino-17-demethoxygeldanamycin use different ways to stop cancer cells from     dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill     more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of     17-N-allylamino-17-demethoxygeldanamycin when given together with imatinib mesylate in     treating patients with chronic myelogenous leukemia.   "
170273|NCT00066339|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have     metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase     inhibitor therapy.   "
170274|NCT00066352|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary     for their growth.      PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with     advanced or metastatic transitional cell cancer of the bladder, renal pelvis, or ureter.   "
170275|NCT00066365|"     RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the     growth of tumor cells and shrink the tumor so that it can be removed during surgery.     Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective     treatment for osteosarcoma that has spread to the lung.      PURPOSE: This phase II trial is studying how well inhaled sargramostim works in treating     patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread     to the lung.   "
172639|NCT00102869|"     The purpose of this study is to determine whether levodopa, in combination with a high     frequency language training, is effective in boosting naming performance in patients with     aphasia.   "
170276|NCT00066378|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     anastrozole may fight breast cancer by reducing the production of estrogen. Gefitinib may     stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining     anastrozole with gefitinib may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of anastrozole with or     without gefitinib in treating postmenopausal women who have metastatic or locally recurrent     breast cancer.   "
170277|NCT00066391|"     RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to     stop tumor cells from dividing so they stop growing or die. Combining irinotecan with     cisplatin may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in     treating patients who have locally advanced or metastatic penile cancer.   "
170278|NCT00059098|"     To find genes important in the susceptibility to coronary heart disease.   "
170279|NCT00059111|"     To identify the early effects of obstructive sleep apnea on the cardiovascular system of     children.   "
170280|NCT00059124|"     To study the epidemiology of aortic calcium.   "
170281|NCT00059137|"     This study will evaluate the effectiveness of a flexible belt device in guiding patient     breathing during computed tomography (CT)-guided needle biopsy. When patients undergo CT     scanning to help guide the physician during a tissue biopsy, they are usually asked to hold     their breath while the scan is taken of certain parts of the body. When the first scan is     completed, the patients are allowed to breathe, and are then asked to hold their breath again     while the needle is advanced towards the tissue to be biopsied. Since body organs and tissues     move with breathing, this study will try to stop the patient's breathing at the same place in     the breathing cycle to ensure that the biopsy target stays still and in the same place. This     study will see if the flexible belt, used with a computer screen that charts the patient's     breathing, will improve the patient's ability to stop breathing at the same place in the     breathing cycle before and during the biopsy.      Patients 18 years of age and older who have a lesion requiring a needle biopsy in the chest     or abdominal area may be eligible for this study. The biopsy procedure must require CT scan     guidance.      Participants will undergo the following procedures:        -  Breathing exercise: A flexible, loose-fitting belt is placed around the patient's          abdomen and the patient is asked to stop breathing in the following ways: 1) take a deep          breath in and hold; 2) breathe deeply out and hold; and 3) breathe regularly and hold.        -  Needle biopsy: The patient is positioned in a CT scanner and is asked to hold his or her          breath while an initial scan is taken. Then the patient is taken out of the scanner and          the place the needle entry site for the biopsy is marked on the skin. A local anesthetic          is applied to the site and the patient is asked to hold his or her breath the same way          as before. During this breath hold, the patient may or may not be shown a computer          screen displaying a graph of the patient's breathing and the point in the cycle of the          previous breath hold. The biopsy is then performed with CT guidance. While the CT          pictures are being taken, the patient is again asked to breathe and hold his or her          breath as before. When the biopsy is completed, the belt device is removed.   "
170282|NCT00059189|"     This study will examine whether blind people develop changes in the brain that improve memory     function. Previous studies have shown that blind people, on average, perform better in memory     tasks than sighted people. A possible reason for this is that parts of the brain that process     visual information in sighted individuals are engaged in processing mnemonic (remembering)     information in blind people.      Blind and sighted people 18 years of age and older are eligible for this study. Healthy,     sighted individuals may participate in Part 1 of the study, which is designed to find     appropriate words to use in tests for Part 2 of the study. Part 2 will include sighted people     and blind people. It will examine whether the (visual) brain in blind people is processing     mnemonic information in a way that helps with day-to-day memory functions. Blind participants     in this study must have lost their sight by age 4. Candidates will be screened with a medical     interview and examination and a brief test of short-term and long-term verbal memory. Sighted     patients will also be tested for visual memory and for handedness.      Part 1 - Word Recognition Testing (2 sessions)        -  Session 1: Participants listen to a number of words over a loudspeaker and try to          remember them for a memory test that will be given 30 minutes later. For the test,          subjects listen to words again and press one of three buttons as quickly as possible          after hearing the word. The buttons signal whether the subject does or does not          recognize the word with a 1) high level of confidence or 2) low level of confidence.        -  Session 2: Participants hear a noun over a loudspeaker and have to find an appropriate          verb for it, such as the verb (read) for the noun (book).      Part 2 - MRI Scanning and TMS Experiments (5 - 7 sessions)        -  Magnetic resonance imaging (MRI): Participants perform the same procedures as described          above for Part 1 while undergoing MRI of the brain. For this test, the subject lies on a          table inside the MRI scanner - a narrow cylindrical tube with a strong magnetic field.          Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and          90 minutes. (Earphones are used to hear the words for this test instead of a          loudspeaker.)        -  Transcranial magnetic stimulation (TMS): Participants undergo TMS while performing the          same procedures described for Part 1. For TMS, a wire coil is held over the scalp. A          brief electrical current is passed through the coil, creating a magnetic pulse that          stimulates the brain. Subjects may hear a click and feel a pulling sensation on the skin          under the coil. There may be a twitch in muscles of the arm or leg. During the TMS,          electrical muscle activity is recorded through the electrodes with a computer or other          recording device. Each session lasts a maximum of 3 hours.   "
170283|NCT00059202|"     This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for     patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be     approximately five years with important clinical endpoints such as death, eligibility for     liver transplantation, changes in histology and cholangiogram as well as liver biochemistries     and quality of life data collected.   "
170292|NCT00059319|"     The purpose of this trial is to determine whether aortic manipulation in patients undergoing     coronary bypass graft surgery leads to increased incidence of microemboli and subsequent     impairment of neurobehavioral function.   "
170284|NCT00059215|"     The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as     prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also     referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in     the heart using a catheter (a long thin tube) that has a small balloon on the end. In many     cases, patients who have this procedure receive a stent, a small wire spring that helps keep     the vessel open.   "
170285|NCT00059228|"     This study evaluates the efficacy of estrogen treatment in women with postpartum depression     (PPD).      PPD causes significant distress to a large number of women; the demand for effective     therapies to treat PPD is considerable. Estradiol therapy has a prophylactic effect in women     at high risk for developing PPD. The prevention of a decline in estradiol levels may prevent     the onset of PPD. Studies also suggest that estradiol has antidepressant effects in women and     may provide a safe and effective alternative to traditional antidepressants in women with     PPD.      Participants will be screened with a medical history, physical examination, blood and urine     tests, psychological tests, genetic studies, and self-rating scales and questionnaires. Upon     study entry, women will be randomly assigned to wear skin patches containing either estradiol     or placebo (a patch with no active ingredient) for 6 weeks. Women who receive estradiol and     do not menstruate during the last week of the study will receive progesterone for 7 days to     initiate menstruation. Women who receive placebo and do not menstruate during the last week     of the study will continue to receive placebo at the end of the study. Every week,     participants will have blood taken and will be asked to complete symptom self-rating scales.     A urine sample and blood samples will be collected at different time points through out of     the study. Participants who receive placebo and those whose symptoms do not improve with     estradiol therapy will be offered treatment with standard antidepressant medications for 8     weeks at the end of the study.   "
170532|NCT00069589|"     Alopecia areata is the loss of hair in patches that can proceed to loss of all hair (alopecia     totalis or universalis). The purpose of the registry is to collect patient information and     blood samples from people with alopecia areata.   "
170286|NCT00059241|"     Working with multiple schools in Brooklyn, NY, this study will develop and evaluate school-     and community-based strategies designed to reduce early sexual activity and risky sexual     behavior in middle school-aged children. These strategies will focus on parent education,     classroom health curriculum, and learning through participation in community service.   "
170287|NCT00059254|"     Differences in how diet fats are converted to energy could explain some of the reported     differences in health effects among different classes of dietary fat (e.g. monounsaturated     vs. saturated). Recently, this laboratory showed that monounsaturated fats are turned into     energy more readily than saturated fats. These results may mean that if one feeds more     monounsaturated fatty acids (MUFA) and less saturated fatty acids (SFA) in the diet, body fat     might accumulate at a lower rate. This could affect the risk of obesity and Type 2 Diabetes.     This project has two principal Specific Aims which will be assessed in healthy young adults     who are fed liquid formulas containing either an approximately equal amount of MUFA and SFA     (controls) or a much greater amount of MUFA and much less SFA:        1. To determine if a higher intake of MUFA and a reciprocally lower intake of SFA is          associated with a higher rate of fat oxidation. We hypothesize that the rate of fat          oxidation after eating will be higher in those subjects randomized to the MUFA-enriched          diet compared to controls.        2. To measure energy intake required to maintain constant body weight during each diet and          to measure fat-free mass and fat mass, before and after each dietary change. We          hypothesize that those on the high MUFA diet will need a higher energy intake required          to maintain constant body weight.   "
170288|NCT00059267|"     Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver     transplantation offers the only hope for patients who develop end-stage liver disease. Early     results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and     1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B     immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence     rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as     intravenous infusion in high doses is very expensive, while long-term use of lamivudine is     associated with drug resistance. Some studies found that preventive therapy using both HBIG     and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of     HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral     medication, is effective against lamivudine resistant hepatitis B but its role in liver     transplantation is uncertain because of the risk of kidney damage. Many studies showed that     the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it     may be possible to tailor the preventive therapy according to the risk. The aim of this study     is to establish the most cost-effective preventive therapy for recurrent hepatitis B after     liver transplantation.   "
170289|NCT00059280|"     Pompe disease (also known as glycogen storage disease type II, GSD-II) is caused by a     deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally,     GAA is used by the body's cells to break down glycogen (a stored form of sugar) within     specialized structures called lysosomes. In patients with Pompe disease, an excessive amount     of glycogen accumulates and is stored in various tissues, especially heart and skeletal     muscle, which prevents their normal function. This study is being conducted to evaluate the     safety and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential     enzyme replacement therapy for Pompe disease. Patients diagnosed with infantile-onset Pompe     disease who are less than or equal to 6 months old will be studied.   "
170290|NCT00059293|"     To use transcranial Doppler (TCD) ultrasound to detect stroke risk in children with sickle     cell disease.   "
170291|NCT00059306|"     The goal of this study is to learn if combination antiplatelet therapy (aspirin and     clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and     cognitive decline, and if intensive blood pressure control is associated with fewer recurrent     strokes and cognitive decline.      On July 21, 2011 the DSMB recommended terminating the anti platelet arm of the study due to     an imbalance of overall and major non-CNS hemorrhagic SAE's and total deaths in the     investigational anti platelet combination of aspirin + clopidogrel and an interim statistical     analysis that demonstrated futility in the investigational anti platelet arm. It was     recommended that patients be continued on standard care of aspirin mono therapy until their     study close-out visit. Also, recommended the continuation and completion of the plood     pressure arm following the protocol.   "
170294|NCT00059345|"     Interactions between patients and healthcare providers may have a significant impact on a     patient's response to therapy. In this study, patients with osteoarthritis (OA) of the knee     will receive either acupuncture or sham acupuncture. The acupuncturists will be trained to     interact with the patients in specific ways. The study will evaluate those interactions.   "
170295|NCT00059358|"     This study will test the amount of anti-HIV drugs in the blood cells of HIV-infected patients     who are also being treated for hepatitis C virus (HCV) infection.   "
170296|NCT00059371|"     The Luo tribe of Kisumu, Kenya, does not traditionally practice male circumcision (MC). This     study will work with the Luo tribe to test the effectiveness of MC on reducing the risk of     HIV infections in young men.   "
170297|NCT00059384|"     Anti-HIV drugs are usually given to patients at fixed, standardized doses. This study will     investigate alternative ways of dosing anti-HIV drugs to improve viral control.      Study hypothesis: The optimal dosage regimen required to obtain the maximum benefit from     antiretroviral therapy is achieved with strategies that control for pharmacokinetic and     pharmacodynamic variability among patients.   "
170298|NCT00059397|"     To compare MR imaging findings with biopsy for grading and staging early hepatitis C.   "
170299|NCT00059410|"     The TIPS Study, or Treatment and Illness Perceptions Survey, is a study funded by the     national Alzheimer's Association to learn more about differences between African Americans'     and Whites' attitudes, beliefs, and experiences related to Alzheimer's disease (AD). The     study involves a one-time 30-minute telephone survey in which participants are asked about a     range of topics related to AD, including their personal experiences, their beliefs about the     disease's symptoms and risk factors, and their attitude toward possible future treatment     options. Information from the survey will be used to develop more culturally sensitive health     education and healthcare services for persons with AD.   "
170300|NCT00059423|"     In recent decades, hematologists have noticed that persons of African descent sometimes have     lower white blood cell counts of a certain type, called granulocytes. These cells help to     fight infections. The lower number of granulocytes in this situation does not appear to lead     to more infections, and these individuals do not have any symptoms. This condition is called     benign ethnic neutropenia (BEN), and is observed in a small percentage of individuals of     African descent. This study will investigate the condition by studying people with and     without BEN.      The goals of this study are to:        1. identify individuals of African descent with BEN.        2. determine the effects of two drugs, G-CSF and dexamethasone, on granulocyte production          and movement.        3. determine whether there are differences in those with and without BEN in the way genes          are stimulated after the administration of G-CSF and dexamethasone.      Study participants will be asked to interview with the research team, undergo physical exams,     donate a blood sample, and receive G-CSF by injection, followed by dexamethasone (orally)     about three weeks later. They also will be required to undergo apheresis three times, a     procedure in which blood is drawn from a donor and separated into its components. Some     components are retained for research analyses, such as granulocytes, and small amount of     blood; the remainder is returned by transfusion to the donor. This procedure will be required     of participants before they receive G-CSF, the day after they receive G-CSF, and the day     after they receive dexamethasone. Gene messages (mRNA will be isolated from granulocytes, and     analyzed to better understand granulocyte growth and movement.   "
170301|NCT00059436|"     The purpose of this study is to determine the effect of mental effort on improving muscle     strength.   "
170302|NCT00059449|"     Necrotizing enterocolitis (NEC) is a serious gastrointestinal disorder that primarily affects     preterm infants. About 10% of babies less than 32 weeks gestation at birth will develop it.     Overall, 30% of babies who develop NEC will die from it, with many others developing long     term gastrointestinal problems. The most important factor in its development is a premature     intestinal tract. Epidermal growth factor (EGF) is an important growth factor in the     development and maintenance of the gastrointestinal tract. This study will look for a     relationship between EGF levels in premature babies and the development of NEC.   "
170303|NCT00059462|"     The purpose of this study is to evaluate the safety of the experimental drug Bay 50-4798 in     HIV positive patients receiving HAART and to test the drug's effect on the CD4+ T-cell count.   "
170304|NCT00059475|"     This study will examine the effectiveness and side effects of an experimental vaccine to     prevent recurrence of melanoma. The likelihood of melanoma returning is higher in patients     who have melanoma lesions deep in the skin, in patients who have had positive lymph nodes,     and in patients who have had surgery for metastatic disease (cancer that has spread beyond     the primary site). Melanoma tumors produce proteins called glycoprotein 100 (gp100) and     melanoma-associated antigen recognized by T cells 1 (MART-1). Vaccination with specific     pieces of these proteins (peptides) may boost the immune system's fight against the cancer.     The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which     is intended to increase the immune response to the peptide.      Patients 16 years of age and older whose melanoma has been surgically removed and who are     currently free of disease may be eligible for this study. Candidates will be screened with a     physical examination and blood and urine tests. An electrocardiogram (EKG), x-rays and other     imaging studies will be done if recent results are not available. Some candidates may require     heart tests, such as a cardiac stress test or echocardiogram, or lung function tests. In     addition, all candidates will be tested for human leukocyte antigen (HLA) tissue type;     patients must be type human leukocyte antigens (HLA-A)*0201, the type on which this vaccine     is based.      Participants will be randomly assigned to receive one of four different vaccines to determine     which peptides offer the best immunity. Each treatment course consists of two injections of     the vaccines every 3 weeks for four times. The injections are given under the skin of the     thigh. After every other treatment course (every 6 months), patients will undergo a series of     x-rays and scans to look for tumor. The immunizations may continue for up to 12 months as     long as the melanoma does not return. The injections are given at the National Institutes of     Health (NIH) Clinical Center. Patients are monitored for 1 hour after each injection and have     blood tests and a physical examination to look for treatment side effects.      Patients will be followed with blood tests every 12 weeks to monitor body functions. They     will also undergo leukapheresis-a procedure to collect white blood cells-before starting     treatment and about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect     the action of the immune system cells. For this procedure, blood is drawn through a needle in     the arm, similar to donating blood. The blood goes through a machine that separates out the     lymphocytes (white blood cells), and the rest of the blood is returned through a needle in     the other arm. Some patients may undergo a biopsy-surgical removal of a small piece of tissue     under local anesthetic-of normal skin and tumor or lymph node tissue to examine the effects     of the vaccines on the tumor immune cells.      Patients whose disease returns during the first course of vaccine therapy will have surgery     to remove the tumor and will continue to receive the vaccine treatment. Patients whose tumor     returns after completing one course of therapy may receive a substance called interleukin-2     (IL-2), which can boost immune function against the tumor. interleukin-2 (IL-2) is given     intravenously (through a small tube placed in a vein) every 8 hours for 4 days. This regimen     is repeated after 10 to 14 days. Those who respond to interleukin-2 (IL-2) will have a third     course of treatment after 2 months. Patients whose disease recurs after treatment will be     taken off the study and will be referred back to their referring physician or to another     study, if an appropriate one is available.   "
170305|NCT00059501|"     This study will examine loss of balance in the elderly. Falls due to balance problems are a     major health issue in older people, often resulting in bone fractures and other bodily     injuries, and functional decline. In addition, the fear of falling leads some elderly people     to restrict their movements and social activities, causing depressed moods and decreased     enjoyment of life. Risk factors for falling in the elderly include some standing positions in     which older people usually experience balance problems, such as leaning forward or backward.     This study will examine these unstable positions and the brain mechanisms associated with     loss of balance in the elderly.      Normal volunteers between 20 and 90 years of age may be eligible for this study. Candidates     must be in good health, with no difficulties in performing activities of daily living, and     must be able to walk for at least 400 meters (1/4 mile). They will be screened with a medical     history, physical examination, and blood tests.      Participants will undergo the following three experiments:        -  Movement task: The subject stands on a platform with markers placed at different parts          of the body to record body movements. A cap with electrodes (metal disks) is placed on          the head for electrocardiographic (EEG) recording of the electrical activity of the          brain (brain waves) during the experiment. The positions of the feet on the platform are          measured. While standing on the platform, the subject leans forward and backward as far          as possible without losing balance. (Subjects are secured in a safety harness to prevent          actual falls.) The task is repeated 5 times. The experiment lasts up to 2 hours.        -  Postural response task: This study is identical to the first, except that the subject          does not voluntarily lean forward and backward, but is pushed with a device to cause          forward and backward movements. The experiment lasts 1 to 2 hours.        -  Perceptual task: The subject sits in front of a computer screen and watches the postural          movements of a human body model in forward and backward directions. When the subject          recognizes an unstable position in the movements, he or she presses a computer mouse. An          EEG records brain activity during the task, which lasts up to 2 hours.   "
170306|NCT00059514|"     Michigan has the 10th highest smoking rate in the nation. Smoking rates are also very high in     the Middle East and in Arab American families. The purpose of this study is to learn about     tobacco use in Michigan Arab American youth ages 14 to 18. The study will evaluate why some     young people start smoking and others do not. The study will also test an educational program     designed to encourage young people to either quit tobacco use or to avoid it.   "
170307|NCT00059527|"     To reduce the risk for chronic disease, adolescents should eat at least five servings of     fruit and vegetables and be physically active daily. This study will implement and evaluate a     school-based program to encourage adolescents to achieve and maintain a healthy diet and     exercise regimen.   "
170308|NCT00059540|"     This is a longitudinal, multi-site observational study of the long-term effects of a mother's     use of cocaine and/or opiates during pregnancy on her infant. This observational study     evaluates the medical, developmental, social, environmental, and neurobehavioral outcomes for     1,400 of the original cohort of children. A series of follow-up examinations of these     children were conducted in 5 phases: 1-36 months, 3.5-7 years, and 8-11 years. Children are     currently being examined at 13 years of age.   "
170309|NCT00059553|"     Incomplete spinal cord injury often results in difficulty walking. Training on a treadmill     with body weight support may improve walking ability after spinal cord injury. The purpose of     this study is to examine the effect of treadmill speed on spinal cord function and walking     performance.   "
170335|NCT00059917|"     RATIONALE: Drugs used in chemotherapy such as polyglutamate camptothecin may be able to     deliver the drug directly to tumor cells while leaving normal cells undamaged.      PURPOSE: Phase I trial to study the effectiveness of polyglutamate camptothecin in treating     patients who have advanced cancer.   "
170336|NCT00059930|"     The purpose of this study is to find the highest dose that can be given safely to people who     have had liver disease resected. This is a Phase I study. The goal of a phase I study is to     find a safe dose range based on side effects. The drugs that will be given by vein are     OXALIPLATIN (Oxali) plus 5-FLUOROURACIL and LEUCOVORIN (5FU and LV). This is systemic     chemotherapy, since it goes to the whole body. The drugs that will be placed in the pump are     FLOXURIDINE (FUDR) and DEXAMETHASONE. (The dexamethasone is not an anti-tumor drug; it helps     protect healthy liver tissue from possible side effects of the FUDR.) This is the regional     chemotherapy, since it goes only to the liver. The researchers have studied these drugs and     know the best doses of each when they are used in patients who have not had liver resections.     We do not yet know how the drugs work with each other in patients with a liver resection.     This study will tell us the best doses of each drug when they are given over the same period     of time.   "
170310|NCT00059579|"     This study will use magnetic resonance imaging (MRI) to examine how the brain regulates     emotions in healthy people and in patients who have major depression and anhedonia (loss of     feeling of pleasure in things that normally give pleasure).      Healthy normal volunteers and patients between 18 and 50 years of age with major depression,     with or without significant anhedonia, are eligible for this study. Candidates will be     screened with a psychiatric interview, a physical examination that will include blood and     urine samples, and an electrocardiogram, and a questionnaire about their emotions.      Participants will perform a monetary reward task while lying in an MRI scanner. The task is     similar to playing a computer video game with the possibility of winning cash. The amount of     cash is largely dependent on the subject's performance. The accumulated amount of cash earned     in a session will fluctuate depending on the subject's continuing performance level. That is,     during a single session, a subject could lose money earned early in the session if his or her     performance later in the session is not as good as earlier.      MRI pictures will be taken during performance of the task. MRI uses a magnetic field and     radio waves to produce images of body tissues and organs. The patient lies on a table that is     moved into the scanner (a narrow cylinder) and wears earplugs to muffle loud knocking and     thumping sounds that occur during the scanning process. The procedure will last about 1 to     1-1/2 hours.   "
170311|NCT00059592|"     Shingles is an infection commonly seen in children with a weakened immune system     (immunocompromised children). The immune system can be weakened as a result of medications     that patients receive for cancer or other serious illness or as a result of a bone marrow     transplantation. Shingles in children with a weakened immune system may spread throughout the     body and in some instances may be life-threatening. Acyclovir is a medication that is     routinely used to treat immunocompromised children with shingles in order to prevent further     spread of their shingles and to help them heal faster. Acyclovir is also given to bone marrow     transplant patients to prevent reactivation of HSV infection.      Valacyclovir is a new drug that is metabolized (broken down in the body) to acyclovir.     Valacyclovir is given by mouth and studies done in adults have shown it to be more effective     than acyclovir given by mouth.      The purpose of this study is to        -  study the pharmacology of this drug (how the body handles this drug),        -  determine if oral Valacyclovir can be safely given to children with shingles, and        -  determine the type of side effects that occur when oral Valacyclovir is given to          immunocompromised children.   "
170312|NCT00059605|"     The goal of this clinical research study is to find out the highest safe dose of     DOTAP:Chol-fus1 that can be given to participants in the treatment of non-small cell lung     cancer (NSCLC) or small cell lung cancer (SCLC). This study is an attempt to transfer a gene     (fus1) into cancer cells, using the drug DOTAP:Cholesterol-fus1. Researchers will also study     the side effects of this experimental gene transfer at different doses, and will conduct     tests to see if there are any effects on tumor size at different doses. Experimental transfer     of the fus1 gene into humans has never been tried before.      Objectives:        -  Assess the toxicity of DOTAP:Cholesterol-fus1 Liposome Complex (DOTAP:Chol-fus1)          administered intravenously.        -  To determine the maximal tolerated dose and recommended phase II dose of DOTAP:Chol-fus1          administered intravenously.        -  Assess the expression of fus1 following intravenous delivery of DOTAP:Chol-fus1 in tumor          and normal bronchial epithelial cell biopsies.        -  Assess any anti-cancer activity for DOTAP:Chol-fus1.   "
170313|NCT00059618|"     The goal of this clinical research study is to find the highest safe dose of PS-341 that can     be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal,     or fallopian tube cancer. Researchers also hope to find out if giving these drugs together     will help shrink or slow the growth of tumors in patients who are considered resistant to     platinum drugs. The safety of these drugs will also be studied.   "
170314|NCT00059631|"     Primary Objective:      -Establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of weekly     mitoxantrone in combination with weekly PS-341 in patients with advanced AI-PCa.      Secondary objectives:        -  Evaluate the effect of bortezomib and mitoxantrone in combination on PSA levels among          patients with baseline PSA levels >/=5 ng/mL who are treated near the maximum tolerated          dose.        -  Monitor the effect of escalating doses of bortezomib combined with mitoxantrone on          selected parameters of clinical benefit (i.e. performance status, tumor-related          symptoms, measurable disease response).   "
170315|NCT00059644|"     Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia     (CLI), which is the most severe form of peripheral arterial disease (PAD). This trial is     designed to assess the efficacy and safety of the drug in the treatment of CLI.   "
170316|NCT00059657|"     Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia     (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is     designed to assess the efficacy and safety of the drug in the treatment of CLI.   "
170317|NCT00059670|"     The aim of this research study is to determine the effectiveness of: 1) a traditional therapy     regimen focusing on individual exercises for pharyngeal (throat) and laryngeal (voice box)     musculature and 2) a new therapeutic exercise, the Shaker exercise.      The primary objective of this 5-year project is to identify which of two therapy programs,     the Shaker exercise versus traditional therapy, results in the largest number of stable,     non-oral dysphagic patients who can swallow safely and return to full oral feeding after 6     weeks of intervention. The study is powered adequately so that this aim can be tested     separately for head and neck cancer and stroke patients. Our primary outcome measure is     return to oral feeding, i.e., 100% of nutrition and hydration by mouth.   "
170318|NCT00059683|"     Pregnant women who have a shortened cervix and have previously had a premature baby are at     increased risk for having another premature baby. This study will determine whether     reinforcing the cervix with a surgical stitch can reduce the chance of a premature birth.   "
170319|NCT00059696|"     After a stroke, many patients are left with an impaired arm. Restricting the use of the good     arm may improve the use of the bad arm. In Constraint-Induced Movement therapy (CI     therapy), the good arm is put in a sling to force increased use of the bad arm. The bad arm     is also trained each day for several weeks. This study will evaluate the effectiveness of CI     therapy in patients with chronic disability after stroke and whether the rate of recovery is     decreased in elderly patients.   "
170323|NCT00059748|"     Purpose:      The purpose of this protocol is 1. To comprehensively evaluate patients with autoinflammatory     diseases clinically, genetically and immunologically at the autoinflammatory disease clinic     at the NIH. 2. To follow patients with autoinflammatory Diseases that are genetically defined     including Neonatal-Onset Multisystem Inflammatory Disease (NOMID), the most severe clinical     phenotype of Cryopyrin-Associated Periodic Syndromes (CAPS), Deficiency of IL-1 Receptor     Antagonist (DIRA), Chronic Atypical Neutrophilic Dermatosis with Lipodystrophy and Elevated     temperatures (CANDLE), and STING-Associated Vasculopathy with onset in Infancy (SAVI), and     those with genetically undefined autoinflammatory disorders to determine long-term disease     outcomes. 3. To develop biomarkers that help us assess disease activity and response to     treatment. 4. To assess the eligibility of affected patients for inclusion in ongoing and     planned treatment protocols.      Goal: The goals of our studies are to understand the underlying immune dysregulation, to     identify the genetic cause and to translate our findings into novel treatments that improve     patients disease outcome.      Eligibility:        -  Patients with known NOMID/CAPS, DIRA, CANDLE, SAVI, CRMO, Still's Disease, and with          other yet undifferentiated autoinflammatory diseases.        -  Healthy adult and pediatric relatives.        -  Volunteers      Design:      Participants will be evaluated at the NIH for 2-5 days. All participants will have a detailed     medical history, physical exam, blood tests and other evaluations depending on the extend of     their autoinflammatory disease.      Participants may also expect the following assessments:        1. Clinical test that help assess organ damage and functional impact such as hearing          vision, memory and learning tests.        2. Imaging studies to characterize the organ involvement of the inflammatory disease          including: X-rays, CT scans, special MRIs, bone scans.        3. Laboratory evaluations including clinical markers of disease activity, research samples          for genetic studies, and blood samples for cytokine/biomarker assessment, and gene          expression profiling.<TAB>        4. Completion of questionnaires to assess disease activity and quality of life.        5. If indicated, other procedures may be administered that include: a lumbar puncture if          CNS inflammation is suspected and a skin biopsy if skin inflammation is present. other          gastrointestinal procedures as they are clinically indicated.        6. Patients my have a research skin biopsy taken.      Participants may return for a single follow-up visits or for long term-follow up depending on     their disease and willingness to be followed long-term.   "
170324|NCT00059761|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Combining chemotherapy with radiation therapy may kill more tumor cells.      PURPOSE: Phase I trial to study the effect on the body when combining irinotecan and     cisplatin with radiation therapy in treating patients who have limited-stage small cell lung     cancer that could not be completely removed during surgery.   "
170325|NCT00059787|"     This phase II trial is studying the side effects of giving erlotinib together with     carboplatin and paclitaxel and to see how well it works in treating patients with stage III     or stage IV ovarian, fallopian tube, or primary peritoneal cancer. Biological therapies such     as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.     Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop     tumor cells from dividing so they stop growing or die.   "
170326|NCT00059800|"     RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming     normal tissue.      PURPOSE: Phase II trial to study the effectiveness of boron neutron capture therapy in     treating patients who have melanoma.   "
170327|NCT00059813|"     Phase II trial to study the effectiveness of combining oblimersen with interferon alfa in     treating patients who have metastatic renal cell (kidney) cancer. Interferon alfa may     interfere with the growth of tumor cells. Oblimersen may increase the effectiveness of     interferon alfa by making tumor cells more sensitive to the drug.   "
170328|NCT00059826|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may     interfere with the growth of tumor cells. Radiation therapy uses high-energy radiation from     x-rays and other sources to kill tumor cells. Combining chemotherapy with interferon alfa and     giving them with radiation therapy after surgery may kill any remaining tumor cells.      PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and     interferon alfa in treating patients who have resected stage I, stage II, or stage III     pancreatic cancer.   "
170329|NCT00059839|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining more than one drug may kill more cancer cells. It is     not yet known if combination chemotherapy with vinblastine is more effective than combination     chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma.      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination     chemotherapy regimens with either vinblastine or vincristine in treating patients who have     newly diagnosed advanced anaplastic large cell lymphoma.   "
170330|NCT00059852|"     RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop     tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor     cells by blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with     erlotinib may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with erlotinib in     treating patients who have metastatic breast cancer that has been previously treated with an     anthracycline and/or a taxane.   "
170331|NCT00059865|"     RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop     tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the     growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining     gemcitabine with pemetrexed disodium may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when     given together with pemetrexed disodium to see how well it works in treating patients with     unresectable or metastatic biliary tract or gallbladder cancer.   "
170332|NCT00059878|"     RATIONALE: Antifungals such as voriconazole may be effective in controlling fungal     infections. Combining voriconazole with interferon gamma may be more effective than     voriconazole alone in treating fungal infections.      PURPOSE: Randomized phase II trial to compare the effectiveness of voriconazole with or     without interferon gamma in treating patients who have aspergillosis or other fungal     infections.   "
170333|NCT00059891|"     RATIONALE: An anal sphincter prosthesis may replace the need for a permanent colostomy and     may improve the quality of life of patients who are undergoing surgery for anal or rectal     cancer.      PURPOSE: Clinical trial to study the effectiveness of an anal sphincter prosthesis in     treating patients who have anal or rectal cancer and are undergoing surgery to remove the     anus and rectum.   "
170334|NCT00059904|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2     may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with     interleukin-2 may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with interleukin-2     in treating patients who have relapsed or refractory intermediate- or high-grade     non-Hodgkin's lymphoma.   "
170337|NCT00059943|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients     with metastatic breast, lung, or prostate cancer.   "
170338|NCT00059982|"     RATIONALE: Perifosine may stop the growth of tumor cells by blocking the enzymes necessary     for tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who     have locally advanced, unresectable, or metastatic pancreatic cancer.   "
170339|NCT00059995|"     RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them     or deliver cancer-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in     treating patients who have refractory or relapsed lymphoma.   "
170340|NCT00060008|"     RATIONALE: New imaging procedures such as fludeoxyglucose F 18 positron emission tomography     (FDG-PET) and magnetic resonance (MR) perfusion imaging may improve the ability to detect     disease progression, help doctors predict a patient's response to treatment, and help plan     the most effective treatment.      PURPOSE: This diagnostic trial is studying how well FDG-PET and MR perfusion imaging work in     finding disease progression and determining response to treatment in patients with     neurofibromatosis 1 and plexiform neurofibroma.   "
170341|NCT00060021|"     RATIONALE: Acupuncture may be effective in relieving mucositis-related pain caused by     chemotherapy in patients undergoing stem cell transplantation.      PURPOSE: Randomized clinical trial to study the effectiveness of acupuncture in treating     mucositis-related pain caused by high-dose chemotherapy in patients who are undergoing stem     cell transplantation.   "
170342|NCT00060086|"     RATIONALE: Pomegranate juice may contain substances that decrease or slow the rise of     prostate-specific antigen (PSA) levels and may be effective in delaying or preventing     recurrent prostate cancer.      PURPOSE: This phase II trial is studying how well pomegranate juice works in decreasing or     slowing the rise of PSA levels in patients who have undergone radiation therapy or surgery     for prostate cancer.   "
170343|NCT00060099|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of or treat early cancer. SGN-00101 may be effective in preventing the     development of cervical cancer in patients with cervical intraepithelial neoplasia.      PURPOSE: This randomized phase II trial is studying how well SGN-00101 works in preventing     cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.   "
170344|NCT00060112|"     Drugs used in chemotherapy such as gemcitabine use different ways to stop cancer cells from     dividing so they stop growing or die. Oblimersen may increase the effectiveness of     gemcitabine by making cancer cells more sensitive to the drug. This phase I trial is studying     the side effects and best dose of oblimersen and gemcitabine in treating patients with     metastatic or unresectable solid tumors or lymphoma   "
170345|NCT00060125|"     This phase II trial is studying how well tipifarnib works in treating patients with     metastatic malignant melanoma. Tipifarnib may stop the growth of tumor cells by blocking the     enzymes necessary for tumor cell growth.   "
170346|NCT00060138|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone     loss and stop the growth of tumor cells in bone. It is not yet known whether monoclonal     antibody is more effective than zoledronate in treating women who have breast cancer and bone     metastases.      PURPOSE: Randomized phase I/II trial to compare the effectiveness of monoclonal antibody with     that of zoledronate in treating women who have breast cancer and bone metastases.   "
170347|NCT00060151|"     RATIONALE: GW786034 may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth and by stopping blood flow to the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of GW786034 in     treating patients with advanced solid tumors.   "
170348|NCT00060203|"     RATIONALE: Drugs used in chemotherapy such as brostallicin use different ways to stop cancer     cells from dividing so they stop growing or die.      PURPOSE: Phase I/II trial to study the effectiveness of brostallicin in treating patients who     have recurrent or refractory multiple myeloma.   "
170349|NCT00060242|"     RATIONALE: Combretastatin A4 phosphate may stop the growth of anaplastic thyroid cancer by     stopping blood flow to the tumor.      PURPOSE: This phase II trial is studying how well combretastatin A4 phosphate works in     treating patients with advanced recurrent or metastatic anaplastic thyroid cancer.   "
170350|NCT00060255|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in     chemotherapy use different ways to stop cancer cells from dividing so they stop growing or     die. Combining chemotherapy with autologous stem cell transplantation or autologous bone     marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and     kill more cancer cells.      PURPOSE: This phase II trial is studying how well eight different high-dose chemotherapy     regimens with or without total-body irradiation followed by autologous stem cell     transplantation or autologous bone marrow transplantation works in treating patients with     hematologic malignancies or solid tumors.   "
170351|NCT00066404|"     RATIONALE: Using BG00001 to insert the gene for interferon-beta into a person's pleural     cavity may improve the body's ability to fight cancer.      PURPOSE: Phase I trial to study the effectiveness of intrapleural BG00001 in treating     patients who have malignant pleural mesothelioma or malignant pleural effusions.   "
170352|NCT00066417|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's     immune system from rejecting the donor's stem cells. When the stem cells from a related     donor, that do not exactly match the patient's blood, are infused into the patient they may     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and     platelets.      PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in     treating patients with high-risk leukemia.   "
170353|NCT00066430|"     RATIONALE: Infrared coagulation may be effective in preventing the development of anal cancer     in patients who have anal neoplasia.      PURPOSE: Pilot study to evaluate the effectiveness of infrared coagulation in preventing anal     cancer in HIV-positive patients who have high-grade anal neoplasia.   "
170354|NCT00066443|"     RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to     stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such     as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral     blood and may help a person's immune system recover from the side effects of chemotherapy.      PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin and docetaxel     with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.   "
170355|NCT00066456|"     Phase I trial to study the effectiveness of low-dose radiation therapy to the abdomen     combined with docetaxel in treating patients who have recurrent or persistent advanced     ovarian, peritoneal, or fallopian tube cancer. Radiation therapy uses high-energy x-rays to     damage tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to     stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with     radiation therapy may kill more tumor cells.   "
170356|NCT00066469|"     RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, prednisone, and     methylprednisolone use different ways to stop cancer cells from dividing so they stop growing     or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them     or deliver cancer-killing substances to them without harming normal cells. Combining     cyclophosphamide and either prednisone or methylprednisolone with rituximab may be effective     in treating lymphoproliferative disease following organ transplantation.      PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide and either     prednisone or methylprednisolone with rituximab in treating patients who have Epstein-Barr     virus-positive lymphoproliferative disease following organ transplantation.   "
170357|NCT00066482|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase I trial to study the effect on the body of combining cyclophosphamide with     cisplatin, etoposide, and bleomycin in treating children who have newly diagnosed malignant     germ cell tumors that are not in the brain and gonads.   "
170358|NCT00066508|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary     for cancer cell growth.      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who     have diffuse large B-cell lymphoma that is refractory to previous chemotherapy.   "
170359|NCT00066547|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: Phase I/II trial to study the effect of monoclonal antibody therapy on the body and     its effectiveness in treating women who have locally advanced or metastatic breast cancer     that was previously treated with combination chemotherapy.   "
170360|NCT00066573|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy, using     exemestane or anastrozole, may fight breast cancer by reducing the production of estrogen. It     is not yet known whether exemestane is more effective than anastrozole in preventing the     recurrence of breast cancer.      PURPOSE: This randomized phase III trial is studying exemestane to see how well it works     compared to anastrozole in preventing cancer recurrence in postmenopausal women who have     undergone surgery for primary breast cancer.   "
170361|NCT00066586|"     RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased     risk of developing breast cancer. Exemestane may be effective in preventing the development     of breast cancer by decreasing estrogen levels and reducing breast density.      PURPOSE: Randomized clinical trial to study the effectiveness of exemestane in preventing the     development of breast cancer by decreasing estrogen levels and reducing breast density in     postmenopausal women who are at increased risk for breast cancer.   "
170362|NCT00066599|"     RATIONALE: Voriconazole may be effective in preventing systemic fungal infections following     chemotherapy.      PURPOSE: Phase II trial to study the effectiveness of voriconazole in preventing systemic     fungal infections in children who have neutropenia after receiving chemotherapy for leukemia,     lymphoma, or aplastic anemia or in preparation for bone marrow or stem cell transplantation.   "
170363|NCT00066612|"     RATIONALE: Drugs used in chemotherapy such as irinotecan use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who     have recurrent or refractory advanced transitional cell cancer of the urothelium.   "
170364|NCT00066625|"     Phase I trial to study the effect on the body of combining oxaliplatin with bortezomib in     treating patients who have metastatic or unresectable cancer. Drugs used in chemotherapy such     as oxaliplatin use different ways to stop cancer cells from dividing so they stop growing or     die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for     tumor cell growth. Combining oxaliplatin with bortezomib may kill more cancer cells   "
170365|NCT00066638|"     Drugs used in chemotherapy such as FR901228 use different ways to stop cancer cells from     dividing so they stop growing or die. Phase II trial to study the effectiveness of FR901228     in treating patients who have relapsed or refractory multiple myeloma   "
170366|NCT00066651|"     RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.     Immunotoxin therapy may be effective in treating advanced solid tumors.      PURPOSE: This phase I trial is studying the side effects and best dose of immunotoxin therapy     in treating patients with recurrent unresectable advanced solid tumors.   "
170367|NCT00066664|"     RATIONALE: The presence of specific serum proteins may allow a doctor to determine if a     patient has mycosis fungoides/cutaneous T-cell lymphoma.      PURPOSE: This clinical trial is studying how well blood protein analysis detects mycosis     fungoides/cutaneous T-cell lymphoma.   "
170368|NCT00066677|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such     as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing     or die. Combining bevacizumab with docetaxel may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well     they work compared to bevacizumab alone in treating patients with metastatic pancreatic     cancer.   "
172660|NCT00093249|"     The purpose of this study is to determine the efficacy of clevidipine injection versus     placebo in treating preoperative hypertension.   "
170369|NCT00066690|"     RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function     suppression combined with hormone therapy using tamoxifen or exemestane may fight breast     cancer by reducing the production of estrogen. It is not yet known whether suppression of     ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone     in preventing the recurrence of hormone-responsive breast cancer.      PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or     exemestane to see how well they work compared to tamoxifen alone in treating premenopausal     women who have undergone surgery for hormone-responsive breast cancer.   "
170370|NCT00066703|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of     estrogen. It is not yet known whether giving triptorelin together with exemestane is more     effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.      PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how     well they work compared to triptorelin and tamoxifen in treating premenopausal women with     hormone-responsive breast cancer.   "
170371|NCT00066716|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase     the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.     Celecoxib may also stop the growth of tumor cells by stopping blood flow to the tumor and/or     may block the enzymes necessary for their growth. Combining celecoxib with paclitaxel and     carboplatin before surgery may shrink the tumor so that it can be removed during surgery.     Giving celecoxib alone after surgery may kill any remaining tumor cells.      PURPOSE: This phase II trial is studying how well giving celecoxib together with paclitaxel     and carboplatin works in treating patients who are undergoing surgery for esophageal cancer.   "
170372|NCT00066729|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: This phase I trial to studying the side effects of vaccine therapy in treating     patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.   "
170373|NCT00066742|"     This phase II trial is studying how well giving tirapazamine together with cisplatin,     etoposide, and radiation therapy works in treating patients with limited-stage small cell     lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Tirapazamine may make the tumor cells more     sensitive to chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy     with tirapazamine may kill more tumor cells.   "
170374|NCT00066768|"     This randomized phase I trial is studying the side effects and best dose of suramin when     given together with either docetaxel or gemcitabine in treating patients with stage IIIB or     stage IV non-small cell lung cancer that is refractory to platinum chemotherapy (such as     cisplatin, carboplatin, or oxaliplatin). Drugs used in chemotherapy such as docetaxel and     gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die.     Some tumors become resistant to chemotherapy drugs. Combining suramin with either docetaxel     or gemcitabine may reduce resistance to the drugs and kill more tumor cells.   "
170375|NCT00066781|"     RATIONALE: Drugs used in chemotherapy such as gemcitabine and irinotecan use different ways     to stop tumor cells from dividing so they stop growing or die. Combining more than one drug     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan     works in treating patients with cancer of unknown primary origin.   "
170376|NCT00066794|"     RATIONALE: Drugs used in chemotherapy, such as cyclosporine, daunorubicin, and cytarabine,     use different ways to stop cancer cells from dividing so they stop growing or die. Combining     more than one drug may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving cyclosporine together with     daunorubicin and cytarabine works in treating older patients with untreated acute myeloid     leukemia.   "
170542|NCT00069732|"     The goal of this study is to pilot test in a group of overweight-obese individuals the     feasibility and acceptability and indications of efficacy of two CAM treatments, qigong, and     acupressure-TAT, for improving long term maintenance of weight loss.   "
170377|NCT00067366|"     Temporomandibular Disorder (TMD) is a widespread chronic pain condition. Successful     psychosocial treatments for TMD have been developed, but the mechanisms by which these     treatments achieve their effects are not well known. The goal of this project is to evaluate     the possible mechanisms responsible for treatment gains in TMD treatment.   "
170378|NCT00067379|"     The primary objective of this study is to examine the usefulness of early orthodontic     intervention as a means of increasing access to orthodontic services for children of     low-income families.   "
170379|NCT00067392|"     The purpose of this study is to determine the difference in success when placing implants     immediately into an extraction site compared to delaying the implant placement until the     extraction site has healed. In addition, the level of bone around the implants will be     compared to determine if one method leads to better results over time.   "
170380|NCT00067405|"     The purpose of this study is to determine if intravenous micronutrient therapy (IVMT) is     effective in the treatment of fibromyalgia, as assessed by validated functional and pain     measures.   "
170396|NCT00067613|"     This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking     -- comparing care practices between different NICUs to see which practices prevent     bronchopulmonary dysplasia (BPD) -- and quality improvement would change practices and     improve rates of survival without BPD in inborn neonates with birth weights of <1250 grams.     Benchmarking is a method involving detailed comparisons of processes between similar     organizations. For this study, three NRN centers with the lowest rates of BPD have been     identified as Benchmark centers. During a 6-month pre-intervention period, details of care     practices and management style at these centers were carefully assessed. Based on practices     at these Benchmarking sites, we developed a quality improvement program. For this study, 14     other NRN sites were randomized to either implement the benchmarking intervention     (intervention sites) or continue with their usual care practices (control sites). After the     1-year intervention period, we compared changes in the rate of survival without BPD at 36     weeks corrected age between the intervention and control sites.   "
170381|NCT00067418|"     This study will use light scattering spectroscopy (LSS) to analyze brain tissue removed from     patients during brain surgery to determine if this new technology can be used to     differentiate between normal and cancerous cells. LSS focuses light on cells or tissues, and     the way that light is reflected back from the tissues provides information about the size of     cells and the density of the cell nuclei (the part of the cell that contains the genes).      Patients between 18 and 75 years of age with a known or suspected brain tumor and patients     with temporal lobe epilepsy that does not respond to medication may be eligible for this     study. (Examination of tissue from patients with epilepsy will allow comparison of tumor and     non-tumor brain cells.) All patients must require surgery to treat their condition.      Participants will be admitted to the Clinical Center for 3 to 10 days for physical and     neurological examinations, blood and urine tests, and other tests needed to prepare for     surgery. They will then undergo surgery. A small amount of tissue removed during surgery for     pathological review will be collected for use in this study.      Half of the tissue will be examined using LSS to help determine the size of the cell and its     nucleus. Studies will be done to measure how many of the cells are actively dividing and     which proteins are expressed more often in tumor cells compared with normal cells. This     information may shed light on how tumor cells are different from normal cells.      Participants may be contacted for up to 3 years to follow their health status.   "
170382|NCT00067431|"     The purpose of this study is to compare the safety and efficacy of two concentration ranges     of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of     partial seizures, with or without secondary generalization, in children 3-10 years.   "
170383|NCT00067444|"     Major Depressive Disorder (MDD) Study in Elderly Outpatients   "
170384|NCT00067457|"     The purpose of this study is to compare the safety and effectiveness of as needed versus     fixed dosing of an investigational medication for women with severe diarrhea-predominant     Irritable Bowel Syndrome (IBS) who have failed conventional therapy.   "
170385|NCT00067470|"     The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance     endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in     the number of meters walked in the 12 minute walk test at Week 24 compared with baseline.   "
170386|NCT00067483|"     This study will use a new dynamic light scattering device (DLS), developed jointly by NASA     and the NEI, to study pre-senile cataracts (cataracts that develop in patients 55 years old     or less). Cataract is a clouding of the lens that interferes with the passage of light to the     retinal, impairing visual acuity. DLS uses a low intensity laser light (similar to that used     in supermarket checkouts) to measures lens cloudiness. It detects changes in the human lens     at the earliest molecular stages of cataract development, when anti-cataract treatment would     be most effective in reversing, delaying or preventing cataract formation.      Patients 55 years of age or younger with cataract may be eligible for this study. Candidates     will be screened with the following tests and procedures:        -  Medical history and physical examination.        -  Eye examination, including measurement of visual acuity (vision chart) and eye pressure;          examination of pupils and eye movements; dilation of the pupils for examination of the          lens and the back of the eye (retina).        -  Cataract photography using a camera with a bright flash to assess the status of the          cataract and evaluate future changes.        -  Blood drawing if necessary for clinical care.      Participants will have a standard eye examination, as described above, plus DLS testing. For     this procedure, the patient sits in front of the DLS device, with the chin placed on a chin     rest. He or she fixes on a yellow-green target in the center of the camera lens. When the eye     is properly aligned, the measurement is taken and the reddish light on the side of the camera     lens turns on for 5 seconds. Measurements are taken on three layers of the lens. The     procedure takes less than 30 minutes.      Participants will be followed at the NIH clinic once a month for up to 1 year to follow     progression of the cataract. The visits will include a repeat of some of the exams listed     above.   "
170387|NCT00067496|"     This study, conducted at the Walter Reed Army Medical Center, the National Rehabilitation     Hospital, and the National Institutes of Health, will examine whether the drug Modafinil can     decrease fatigue in patients with post-polio syndrome. Many people who have had polio develop     weakness and severe fatigue several years after their recovery from the acute disease.     Modafinil is approved by the Food and Drug Administration to improve wakefulness in patients     with narcolepsy (disease in which patients have excessive daytime sleepiness) and has been     used to treat patients with fatigue related to other medical conditions, such as multiple     sclerosis. This study will compare the effects of two doses of Modafinil and of a placebo (a     pill with no active ingredient) on fatigue in patients with post-polio syndrome.      Patients who develop fatigue, weakness, muscle pain or atrophy, and functional loss at least     15 years after recovering from polio and whose symptoms cannot be attributed to another cause     may be eligible for this study. Candidates will be screened with a medical history, physical     and neurological examinations, fatigue rating scales, electrocardiogram, blood and urine     tests, drowsiness and depression evaluations, and an electroymogram (EMG) to diagnose nerve     or muscle problems. For the EMG, electrodes (small metal discs) are taped to the skin and a     needle is inserted into a muscle to record the electrical activity.      Candidates will also undergo a sleep study to exclude abnormal sleep patterns as the cause of     the fatigue. For this study, patients stay overnight at the NIH hospital. Electrodes are     placed on the throat, on a finger, and on the chest (for an electrocardiogram), and a     respiratory belt is placed around the chest-abdomen area. During sleep (from 10:30 p.m. to 6     a.m.), brain waves, eye and leg movements, muscle tone, respiration, and heart rate are     recorded. Beginning at 8 a.m. the following morning, the patient takes 20-minute naps to     measure the level of daytime sleepiness, using a recording technique similar to that of the     all-night study. When five naps are completed, the sleep study ends. Candidates may also     undergo a lumbar puncture (spinal tap) to check for certain chemicals in the spinal fluid     that might be related to fatigue and to look for possible causes of post-polio syndrome. This     procedure is optional. For the lumbar puncture, a local anesthetic is given and a needle is     inserted in the space between the bones in the lower back where the cerebrospinal fluid     circulates below the spinal cord. A small amount of fluid is collected through the needle.      Patients enrolled in the study will complete a sleep diary during the entire study period.     They will be randomly assigned to one of two treatment groups-Modafinil or placebo-for 6     weeks, followed by a 2-week washout period with no medication, and then a crossover phase, in     which patients who took Modafinil for the first 6 weeks now take placebo, and those who took     placebo now take Modafinil.      At the first study visit, patients will be given a supply of study medication and have blood     drawn. They will take one pill twice a day during both study phases. In both study phases,     evaluations will be done 3 and 6 weeks after starting the medication. The evaluations include     filling out the same forms completed at the screening visit, a review of drug side effects,     and a review of medical problems since the last study visit. At the 6-week visit, blood is     also drawn.   "
170388|NCT00067509|"     Emergency contraception is a method of birth control that can be used up to three days after     sexual intercourse. Emergency contraceptive pills (ECPs) can be given to a woman before she     needs them (advance provision) or when she needs them (emergency provision). This study will     compare these two methods of providing ECPs.   "
170389|NCT00067522|"     Prevention of unplanned pregnancies among HIV infected couples decreases the rate of     maternal-child virus transmission and the number of children orphaned when parents die of     AIDS. This study will evaluate two programs for reducing the number of unplanned pregnancies     among HIV infected couples in Zambia.   "
170390|NCT00067535|"     The purpose of this study is to assess Potential Interactions Between iv Cocaine and RPR     102681   "
170391|NCT00067548|"     This non-randomized, open-label, outpatient clinical trial is designed to assess the safety     and efficacy of daily orally administered EKB-569 in subjects with advanced non-small cell     lung cancer. Patients must have been previously treated with a platinum- and docetaxel-based     therapy either given concurrently or as separate regimens.      The primary objective of the study is to assess the clinical activity of EKB-569 administered     orally as a second-line or later stage treatment in subjects with advanced non-small cell     lung cancer. Secondary objectives include:        -  To further evaluate the safety of EKB-569        -  To explore additional clinical activity parameters        -  To explore subject survival        -  To evaluate the pharmacokinetics of EKB-569        -  To assess subject reported outcomes      EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569     daily as long as they do not have progressive disease and are tolerating treatment.   "
170392|NCT00067561|"     The purpose of this study is to compare the safety and effectiveness of different doses of an     investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome     (IBS) who have failed conventional therapy.   "
170393|NCT00067574|"     This study will attempt to stimulate the immune system in HIV infected adolescents and young     adults so that it can better control the HIV infection. When anti-HIV drugs are stopped for a     period of time, the virus grows back. This may stimulate the immune system, which may then     be more effective in controlling the virus.   "
170394|NCT00067587|"     Though anti-HIV drugs can dramatically improve the health of people with HIV, some people     taking these drugs develop serious long term effects in their metabolism. These effects     include problems with bones, increased levels of blood sugar and lipids, and changes in body     fat distribution. The purpose of this study is to see how many young women are experiencing     these problems and how severe the problems are. This kind of study is the first step in     determining how best to treat these problems.   "
170395|NCT00067600|"     Osteoporosis affects nearly half of all American women over age 50. During the teenage years,     girls can increase bone growth to decrease their risk of osteoporosis later in life. This     study will test whether girls can change their food intake and physical activity patterns in     ways that will increase their bone growth during the mid-teen years.   "
170398|NCT00067639|"     In recent years PBPC have replaced bone marrow as the source of hematopoietic stem cells for     autologous transplantation. One of the cited advantages of this procedure is the avoidance of     bone marrow harvest, which frequently requires general anesthesia. Other advantages include     faster neutrophil and platelet engraftment times, faster immune recovery, decrease in the     amount of tumor contamination and technical ability to obtain stem cells from patients     previously considered unharvestable because of marrow fibrosis or because of prior     radiotherapy to the pelvis. Filgrastim has emerged as the preferred cytokine for stem cell     mobilization based on its safety profile and the positive experience in granulocyte donors     however, the number of circulating CD34+ cells does not occur until the third day after     starting filgrastim injections. Pegfilgrastim stimulates the production and maturation of     neutrophil precursors and enhances the functions of mature neutrophils in the same manner as     filgrastim. Data form normal volunteers and in studies of patients with cancer have shown     prolonged serum levels of the cytokine, with self-regulation of pegfilgrastim levels as a     function of the neutrophil count. This confers a therapeutic advantage in clinical settings     by allowing a less frequent dosing.   "
170399|NCT00067652|"     The focus of this study is the development of a school-based multimedia product for the     prevention of body dissatisfaction and unhealthy weight control behaviors in adolescents. The     program is being designed for early adolescents, age 12-14, and will include information on     maturation, healthy eating and exercise, skill building modules and media literacy awareness.   "
170400|NCT00067665|"     How high blood pressure in hemodialysis patients should be diagnosed and treated using     medications or without medications is the purpose of this study.   "
170401|NCT00067678|"     Diabetic nephropathy is a frequent cause of end-stage renal disease. Reduction of dietary     protein has been used to slow down renal disease progression, but patients are often     unwilling to make these dietary changes. Other research suggests that changing the quality of     dietary protein may be as effective as reducing the total amount of ingested protein. This     study hopes to show that soy protein, a plant protein relatively high in essential amino     acids and with high nutritional value, maye be beneficial to Type I diabetic patients with     incipient renal disease.   "
170402|NCT00067691|"     The purpose of this study is to determine whether acupuncture is effective in relieving     shortness of breath among breast and lung cancer patients.   "
170403|NCT00067704|"     The specific objective of this study are to examine whether or not a treatment aimed at     emotional disclosure may have beneficial psychological, health and immune effects for HIV     infected individuals. The goal of the current study is to test the efficacy of emotional     disclosure through writing in patients with HIV infection. We will compare emotional     disclosure through writing about traumatic experiences (experimental intervention) to a     control intervention (writing about emotionally neutral topics). [Note that HIV RNA viral     load, CD4 T cells, urinary cortisol, health related dysfunction, psychological distress, and     medication adherence are the 6 primary outcome variables.   "
170404|NCT00067717|"     This trial examines the impact of patients' knowledge of an experienced distant healer's     efforts to heal them on measures of wound healing, psychosocial functioning, and     physiological symptoms after plastic surgery.   "
170405|NCT00067730|"     The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood     cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for     bone marrow transplant (BMT).   "
170406|NCT00067743|"     This is a multicenter, open-label study in adult subjects with Type 1 Complex Regional Pain     Syndrome. Subjects diagnosed with unilateral Type 1 CRPS will be enrolled sequentially to     receive CC-5013 10 mg/day orally. For each subject the study consists of two phases:     Pre-treatment phase(1 wk) and treatment phase (12 wks)   "
170407|NCT00067756|"     The purpose of this study is to find out whether 4-PBA will increase the level of AAT in     persons with AAT deficiency whether or not they have liver disease.   "
179022|NCT00189800|"     The purpose of this study is to ascertain the clinical results of solifenacin succinate of     PIII study conducted in the original country using Korean patients with an overactive     bladder.   "
170408|NCT00067769|"     Encopresis, also known as fecal incontinence, is the voluntary or involuntary passage of     stools causing soiling of clothes by a child over 4 years of age. The purpose of this study     is to evaluate an Internet intervention for the treatment of encopresis.   "
170409|NCT00067782|"     The purpose of this clinical research study is to learn if atazanavir is associated with     serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for     their previously administered protease inhibitor.   "
170410|NCT00067795|"     Some people's immune systems are able to control HIV infection without anti-HIV drugs. Other     people with HIV must take drugs to prevent the virus from destroying their immune systems.     There are many different laboratory tests that measure immune function in people with HIV.     This study will compare some of these tests to see if they consistently measure differences     between people who control the HIV without anti-HIV drugs and those who must take drugs.   "
170411|NCT00067808|"     The goal of this clinical research study is to learn if decitabine (given at 3 different     doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments     will also be studied.   "
170412|NCT00067821|"     This study in children and young adults will compare two types of imaging, positron emission     tomography ([(18)F]-DG PET) and proton magnetic resonance spectroscopy ((1)H-MRSI), to     determine activity of a brain tumor or abnormal tissue in the brain following treatment for a     brain tumor. Children with brain tumors are generally followed with magnetic resonance     imaging (MRI) scans to evaluate response to treatment. However, because MRI only provides     information on the structure of the brain, it may difficult to tell if an abnormal finding is     due to tumor, swelling, scar tissue, or dead tissue. (1)H-MRSI and [(18)F]-DG PET, on the     other hand, provide information on the metabolic activity of brain lesions. These two methods     will be compared and evaluated for their ability to provide important additional information     on childhood brain tumors.      Patients between 1 and 21 years of age with a brain tumor or brain tissue abnormality     following treatment for a brain tumor may be eligible for this study. Candidates will be     screened with a medical history and physical examination, pregnancy test in women who are     able to become pregnant, and a blood test for glucose.      Participants will undergo the following procedures:      (1)H-MRSI - This test is similar to MRI and is done in the same scanning machine. In MRI,     scans of the brain are obtained by applying a strong magnetic field and then collecting the     signals released from water after the magnetic field is changed. Pictures of the brain are     then obtained by computer analysis of these signals. In (1)H-MRSI, the computer blocks the     signal from water to get information on brain chemicals that can indicate whether an     abnormality is tumor or dead tissue. Both MRI and MRI and (1)H-MRSI are done in this study.      For these tests, the child lies on a stretcher that moves into the scanner - a narrow metal     cylinder with a strong magnetic field. The child's head is placed in a headrest to prevent     movement during the scan. He or she will hear loud thumping noises caused by the electrical     switching of the magnetic field. A contrast agent is given through an intravenous (IV)     catheter (plastic tube placed in an arm vein) or through a central line if one is in place.     The contrast material brightens the images to provide a clearer picture of abnormalities.     Children who have difficulty holding still or being in a scanning machine are given     medications by an anesthesiologist to make them sleep through the procedure. Children who are     awake during the procedure can communicate with the MRI technician at all times and ask to be     removed from the scanner at any time. The MRI and (1)H-MRSI take 1-1/2 to 2 hours to     complete.      [(18)F]-DG PET - For this test, [(18)F]-DG (a radioactive form of glucose) is injected into     the patient's arm vein through a catheter, followed by the PET scan, similar to a very open     MRI scan without the noise. The PET scan tells how active the patient's tumor is by tracking     the radioactive glucose. All cells use glucose, but cells with increased metabolism, such as     cancer cells, use more glucose than normal cells. After the glucose injection, the patient     lies quietly in a darkened room for 30 minutes, after which he or she is asked to urinate to     help reduce the dose of radiation to the bladder. Then, the scan begins. When the scan is     finished (after about 1 hour), the child is asked to urinate again and then every 3 to 4     hours for the rest of the day.      Patients remain in the study for 2 years unless they withdraw, become pregnant, or require     sedation but can no longer use an anesthetic. MRI and 1H-MRSI scans may be repeated every few     months during the study period, if necessary. Only one PET scan is done each year.   "
170413|NCT00067834|"     This study will determine the usefulness of pulsing electromagnetic field (PEMF) technology     to reverse or reduce the bone loss (osteopenia) that occurs in the forearm after fracture or     surgery.   "
170414|NCT00067847|"     Four California school districts will be randomized to early implementation of California's     SB 19 Pupil Nutrition Act or to business as usual. Over 5000 4th, 5th and 7th graders will be     evaluated at baseline, 4-month, and 16-month follow-up in order to determine if the SB 19     nutrition and physical activity policies have had an impact on students' risk of excess body     weight. The impact of early implementation of SB 19 on academic achievement will also be     assessed.   "
170528|NCT00069537|"     Good control of blood glucose levels is important in preventing complications from diabetes.     This study assessed the accuracy and reliability of two FDA-approved continuous glucose     monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2 Biographer     (GW2B), in children with type 1 diabetes mellitus (T1DM).   "
170415|NCT00067860|"     This is a double-blind randomized controlled study on the clinical and metabolic effects and     underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth     hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition.     Clinical endpoints include ability to wean patients from parenteral feeding, metabolic     endpoints include gut nutrient absorptive function and molecular endpoints include expression     of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month     study is performed, in part, in the General Clinical Research Center for inpatient stays and     outpatient visits.   "
170416|NCT00067873|"     Overweight premenopausal Black and White women are randomized to either diet-only,     diet+aerobic or diet+resistance exercise training. Diet/behavior intervention, with or     without the aerobic or resistance exercise training, will be provided throughout the 18     months of study. Major outcomes will include measures of perceived and physiologic difficulty     of exercise (cardiac, ventilatory, electromyographic responses to standardized exercise     tasks); aerobic fitness; strength fitness; and spontaneous free-living energy expenditure     (all derived from doubly labeled water). The results will provide insight into the     effectiveness of, and the mechanisms by which, different types of exercise training can     improve physical fitness, spontaneous engagement in physical activities of daily living and,     in turn, weight-loss maintenance.   "
170417|NCT00067886|"     Matrix metalloproteinases (MMPs) are a family of protein-degrading enzymes that are involved     in the breakdown and remodeling of many tissues and organs. Abnormal activity of these     enzymes has been implicated in many disease processes including rheumatoid arthritis, dental     disease and metastatic cancer. Recent studies also suggest that elevations in blood sugar may     abnormally effect MMP enzyme activity. Decreased activity of some of these MMP enzymes may be     a partial cause of the abnormal enlargement of the kidney (renal hypertrophy) seen at the     start of diabetic kidney disease (nephropathy). Preliminary clinical data from our laboratory     confirm that children with newly diagnosed type 1 diabetes mellitus (DM) have lower blood     levels of some of these enzymes at the time of very high blood sugar readings. However, these     enzyme levels become normal again as blood sugar levels improve with insulin treatment. In     the present study, we propose to investigate the hypothesis that MMPs are involved in the     cause of diabetic kidney disease by measuring concentrations of specific MMPs and some     related proteins in the blood and urine of patients with type 1 DM who are between the ages     of 14-40 years. We will enroll some patients who are recently diagnosed with diabetes, some     who have had diabetes for several years, but without signs of kidney disease, and some with     long-term diabetes and various degrees of kidney disease. Continuous Subcutaneous Glucose     Monitoring, conducted for 3-4 days, will also be provided as a part of this study, to     determine how different levels of blood sugar control might relate to different levels of MMP     enzyme activity in the blood. We anticipate that this study will help to establish a link     between abnormal MMP activity and the cause of nephropathy in type 1 DM, allowing scientists     to design better therapies for the prevention and treatment of diabetes-related kidney     problems.   "
170418|NCT00067899|"     The purpose of this study is to determine if oxidative stress derived from cigarette smoking     increases vitamin E requirements. The study will also assess the role of vitamin C in     modulating vitamin E requirements. Vitamin E requirements will be assessed by measuring     vitamin E in plasma as well as by measuring the excreted vitamin E metabolite in the urine.   "
170419|NCT00067912|"     How duloxetine compares to a medication currently available for the treatment of depression     in the treatment of patients with major depressive disorder.      The safety of duloxetine and any side effects that might be associated with it.   "
170420|NCT00067925|"     The Incorporating More Physical Activity and Calcium in Teens (IMPACT) study was a     behaviorally-based middle school nutrition and physical activity program for the prevention     of osteoporosis. The goal of IMPACT was to increase calcium intake and physical activity to     help build bone mass in girls.   "
170421|NCT00067938|"     Bipolar study of tolerability, clinical response and patient satisfaction   "
170422|NCT00067951|"     The purpose of this research study is to determine if a new investigational diabetes drug is     safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c     or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test     or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood     over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood     after an 8 hour fast.   "
170423|NCT00067964|"     The projects funded by this grant, primarily focus on environmental factors that promote     weight-gain in the general human population, and how to modify these factors, to prevent     further weight-gain in the future. In the coming years, the researchers at the University of     Colorado-HSC hope to gain an understanding as to how small changes in diet and physical     activity can be achieved and sustained to prevent weight-gain.   "
170796|NCT00073840|"     The primary objective of this study is to investigate the efficacy of levalbuterol 90 ug (2     actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of     bronchoconstriction in adolescent and adult subjects with asthma, with all treatments     administered 4 times a day (QID).   "
170424|NCT00067990|"     Chronic allograft nephropathy continues to be a major cause of kidney transplant loss and     return to dialysis. Treatment options are limited and the course of the disease tends to be     progressive. This trial is designed to prevent a major mediator of this process, namely the     expansion of the cortical interstitial compartment of the kidney where most of the scarring     occurs. The drug being studied, Losartan, has proven efficacious in a number of kidney     diseases.   "
170425|NCT00068003|"     Background:      The NCI Surgery Branch has developed experimental therapies that involve taking white blood     cells from patients' tumor or from their blood, growing them in the laboratory in large     numbers, and then giving the cells back to the patient.      Objective:      This study will collect white blood cells from normal volunteers and white blood cells and/or     tumor cells, from patients who have been screened for and are eligible for a NCI Surgery     Branch treatment protocol. The cells collected from normal volunteers will be used as growth     factors for the cells during the period of laboratory growth. The cells and/or tumor from     patients will be used to make the cell treatment product.      Eligibility:      Patients must be eligible for a NCI Surgery Branch Treatment Protocol      Normal Volunteers must meet the criteria for blood donation      Design      Both patients and normal Volunteers will undergo apheresis. Patients will then undergo     further testing as required by the treatment protocol.      There is no required follow up for normal volunteers.   "
170426|NCT00068029|"     The purpose of this study is to compare the safety and tolerability of combination therapy     with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.   "
170427|NCT00068042|"     The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin     LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.   "
170428|NCT00068055|"     This study will look at the safety and effectiveness of an experimental medication containing     antibodies (Omr-IgG-am™) in people with West Nile Virus (WNV) who already have brain and/or     spinal cord inflammation or who are at high risk of developing these problems because they     have weak immune systems. WNV can cause problems such as headaches, fever, muscle weakness,     coma, and death. Study investigators believe people who are not able to fight infection well     may be at risk for developing neurologic problems (having to do with the brain, spinal cord,     nerves, and muscles) if they get WNV infection. Up to 110 subjects, 18 years or older, will     participate for about 3 months and will receive either Omr-IgG-am™, Polygam® S/D, or placebo     given through a small tube placed in a blood vessel in the arm. Hospitalization, up to 5     additional study visits, blood sample collection, MRI pictures of the brain and spinal cord,     and neurological, muscle, and heart activity tests are also required.   "
170429|NCT00068068|"     The purpose of this study is to determine whether the Litx platform is safe and effective in     the treatment of liver metastasis arising from colorectal cancer. Litx is a next-generation     photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by     light from the light-emitting diode (LED)-based light infusion device, inserted directly into     the tumor through the skin prior to treatment.   "
170430|NCT00068081|"     The purpose of the study is to assess the efficacy, safety and tolerability of NGX 4010     applied for 60 minutes for the treatment of PHN.   "
170431|NCT00068094|"     The purpose of this study is to determine whether probiotics, bacteria that may improve liver     health, can effectively treat a chronic condition in diabetics that increases fat in the     liver.   "
170432|NCT00068107|"     This study will determine the safety and effectiveness of increasing Replagal infusions in     certain patients with Fabry disease. Replagal is a genetically engineered form of     Alpha-galactosidase A, an enzyme that normally breaks down a fatty substance called     globotriaosylceramide (Gb3). In patients with Fabry disease, Alpha-galactosidase A does not     function properly and, therefore, Gb3 builds up, causing problems with the kidneys, heart,     nerves, and blood vessels.      Patients with Fabry disease who are participating in NIH protocol 00-N-0185 or 02-N-0220 may     be eligible for this study. This includes patients who are currently taking Replagal but     whose kidney function continues to worsen, or patients who have certain test results that are     much improved after Replagal infusion.      Participants will receive Replagal infusions (0.2 mg/kg body weight) through a vein once a     week (as opposed to the previous dosage of once every 2 weeks) for up to 2 years. The first     infusion, and some others, are given at the NIH Clinical Center, but most are administered by     the patient's local doctor. Vital signs are measured before, immediately after, and 1 hour     after each infusion.      Baseline evaluations are done on an inpatient basis at the NIH Clinical Center over a 1-week     period before and after the first Replagal infusion and at 6-month intervals during the     study. Tests include a check of vital signs (temperature, respiratory rate, pulse rate, and     blood pressure); weight measurement; physical and neurological examinations; routine blood     and urine tests; 24-hour urine collection; electrocardiogram; and review of treatment side     effects. In addition, the following tests are done:        -  Quantitative sensory testing: This is a non-invasive test to measure the ability to          sense warm, cold and vibration in the hand and foot.        -  QSART: This test measures the amount of sweat in a particular area of skin that did not          sweat enough. A small amount of a medicine called acetylcholine is put on the skin and          made to enter the skin using a very small electric current.        -  Doppler skin blood flow: This test measures blood flow to the blood vessels of the skin.          A machine takes pictures of blood flow in the skin of the forearm using a laser beam.          Pictures are taken before and during application of medicines that cause blood vessels          to dilate. Acetylcholine is used on one forearm and nitroprusside is used on the other.          The medication is made to enter the skin using a small el...   "
170433|NCT00068120|"     This project is the clinical project of a Specialized Center of Research (SCOR) proposal     which is designed to further our understanding of urinary tract infection (UTI) in women.     Acute uncomplicated urinary tract infections (UTIs) occur in an estimated 7-11 million women     each year, and the annual costs of caring for these women are thought to approach $1.6     billion. Approximately 20-30% of women suffer from frequent recurrent infections. UTIs in     young women result in substantial symptoms, time lost from work, and medical costs. An     improved understanding of the mechanisms underlying UTIs could result in new approaches to     their prevention and reduced numbers of women with infections and the amount of antibiotics     use.      In this project we seek a better understanding of the causes of UTI. Most experts believe     that vaginal colonization with UTI-causing bacteria from the rectal flora precedes     colonization of the urethra (the tube from the bladder for urination) and bladder and     subsequent UTI, but the relationships between these events has not been established.     Moreover, recent information from studies in mice strongly suggest that persistent bladder     infection follows an initial bladder infection.      In this project, we will prospectively follow a large group of women with recurrent UTI to     determine: 1) the relationships in time between vaginal colonization with a UTI-causing     bacteriuria, asymptomatic bacteriuria (bacteria in the bladder but without any UTI symptoms)     and symptomatic UTI, and 2) the presence of persistent bacteria in the bladder following the     symptomatic UTI at entry into the study and whether such bacteria are related to later UTIs     that are caused by the same bacteria that caused the UTI at entry into the study. We will     thus be able to determine the relative importance of vaginal colonization vs. persistent     infection of the bladder as the origin of the bacteria causing recurrent UTI.      UTI-causing bacteria cultured from women with symptomatic UTI and asymptomatic bacteriuria     will undergo studies by Dr. Scott Hultgren's group at Washington University in Project 1 to     identify unique genes that may help us understand why some bacteria cause symptoms and others     do not. The effect of bacteria causing UTI in these women on host response will also be     determined by studies by Dr. Jeff Gordon's laboratory at Washington University in Project 3.      A better understanding of the molecular and epidemiologic basis of UTI is critical in     developing the best possible prevention and management strategies.   "
170901|NCT00075010|"     Valproic acid is a medication that is currently used in the prevention of seizures, bipolar     disorder, and migraine headaches. Researchers hope that it may improve the effects of     decitabine. Decitabine is a chemotherapy drug with known activity in leukemia and     myelodysplastic syndromes.   "
170434|NCT00068133|"     The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared     with placebo, administered bilaterally to the lower extremities, in subjects with     intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT)     for subjects receiving VLTS-589 compared with subjects receiving placebo.   "
170435|NCT00068146|"     This study will evaluate the usefulness of FDG-PET scanning in distinguishing autoimmune     lymphoproliferative syndrome (ALPS) from lymphoma. Lymphoma is cancer of the lymph system.     ALPS is a condition involving persistent enlargement of the lymph glands, spleen, or liver,     and a range of other problems relating to blood cell counts and abnormal immune activity, in     which the immune system attacks healthy tissues. People with ALPS particularly those with an     abnormal Fas gene also have an increased risk of developing lymphoma. The Fas gene codes for     a protein that causes immune cells called lymphocytes to die when they are no longer needed.      FDG-PET is a new nuclear imaging test that is very effective in detecting lymphoma. It is     important to identify these cancers as quickly as possible, since some are very curable when     caught early. Since ALPS and lymphoma share several common characteristics, a reliable,     non-invasive method of distinguishing the two, such as FDG-PET might offer, is crucial.     FDG-PET uses a radioactive sugar molecule to produce images that show the metabolic activity     of tissues. Because cancer cells grow and divide more rapidly than normal cells, they     metabolize more sugar for fuel. This increased activity identifies them as cancer in FDG-PET     scanning. For this procedure, the subject is injected with the sugar molecule and lies in a     doughnut-shaped machine (PET camera) for the imaging.      Adults and children 10 years old or older with ALPS, with or without lymphoma, may be     eligible for this study. Candidates will be screened with a physical examination, blood     tests, and computed tomography (CT) scan.      Participants will have an FDG-PET scan and a DEXA scan. The DEXA scan measures fat and     non-fat tissue and is used help interpret the FDG-PET results. For this test, the subject     lies on a table while a fast X-ray is taken from head to toe.      Patients who develop signs or symptoms suggesting the development or recurrence of lymphoma     (such as further enlargement of lymph glands, unexplained fever or weight loss, or abnormal     scans) may undergo a tissue biopsy. For this procedure, a small piece of lymph or other     tissue is surgically removed for examination under the microscope. In addition, patients who     develop these symptoms may be asked to undergo additional FDG-PET scans up to two a year in     patients without lymphoma, and as many as needed in patients with lymphoma to evaluate their     response to treatment and guide future therapy.   "
170436|NCT00068159|"     This study will examine the effect of iron buildup in the hearts of patients with hereditary     hemochromatosis (HH), a genetic disease that causes the body to accumulate excess amounts of     iron. The excess iron can damage the heart, liver, pancreas, skin, and joints. Generally,     early treatment with phlebotomy (periodic removal of a unit of blood), and in some cases     chelation (using a drug to remove iron from the body) slows down organ damage in HH patients.     This study will try to elucidate the effect of iron buildup in the heart and determine if     phlebotomy and chelation help keep the heart healthy.      Patients with HH and healthy volunteers 21 years of age and older may be eligible for this     study. (Normal volunteers will provide normal values of heart function that will be used to     verify abnormalities detected in HH patients.) Patients must have a gene abnormality of Hfe     gene Cys282Try homozygote. They may or may not be receiving treatment for HH and they must     have no heart symptoms or serious organ damage due to HH. Candidates will be screened with a     medical history and physical examination, blood tests, electrocardiogram (EKG), Holter EKG     (24-hour EKG monitoring, see description below), and chest x-ray.      Participants will undergo the following tests and procedures over 2 to 5 days:        -  Exercise test: The participant exercises on a treadmill while wearing a mouthpiece,          which is used to measure how much oxygen is used. Electrodes placed on the chest and          arms monitor the heartbeat during the test.        -  Echocardiography: This ultrasound test uses sound waves to take pictures. A small probe          is held against the chest to allow a technician to take pictures of the heart and assess          its function. A drug called Optison may be injected in an arm vein if needed to enhance          the ultrasound images.        -  Exercise stress echocardiography: The participant exercises on a stationary bike while          heart function is measured with an echocardiogram, EKG, and blood pressure cuff.        -  24-hour Holter EKG: The participant wears a small machine that records heart rhythm          continuously for 24 hours. The recorder is connected by cables to electrodes placed on          the chest.        -  Magnetic resonance imaging: This test uses a magnetic field and radio waves to obtain          detailed images of the heart and blood vessels. The participant lies flat on a table          that slides inside the scanner, which is a large hollow tube.      All tests are performed once in normal volunteers and in patients who have received standard     treatment for HH. Untreated patients repeat the tests 6 months after beginning phlebotomy or     chelation. Additional time points for these tests might be added if further evaluation is     needed.   "
170437|NCT00068172|"     The purpose of this study is to determine whether PI-88 is safe and effective in the     treatment of advanced melanoma.   "
170438|NCT00068185|"     Black cohosh is a natural supplement that has been used to treat and prevent menopausal     symptoms. Remifemin is a standardized form of black cohosh. The purpose of this study is to     determine the levels of components of black cohosh obtained in the blood of healthy women     taking Remifemin.   "
170439|NCT00068198|"     The purpose of this study is to attempt to identify the immune response of healthy adults to     an investigational dilution of the Dryvax smallpox vaccine. In addition, we will try to     determine whether certain genetic characteristics influence the size of the sore around the     vaccination site, and use blood samples from subjects in the study to make a new form of     antibody that could be given to people with vaccine side effects.   "
170440|NCT00068211|"     This is a Phase II, non-randomized, open label study of ILX651 in patients with inoperable     locally advanced or metastatic melanoma. Approximately 60 patients will be enrolled in this     study that is expected to last 18 months. All patients will be treated with ILX651     administered IV daily for 5 consecutive days once every 21 days. The primary objective of     this study is to determine the overall response rate for all patients who are treated with     ILX651. The secondary objectives are to determine the progression free survival at 18 weeks,     duration of response, time to tumor progression, survival, safety/tolerability of ILX651 and     to evaluate the pharmacokinetic profile.   "
170441|NCT00068224|"     This study will evaluate patients ciliopathies. People with ciliopathies develop fibrocystic     disease of the kidneys and liver, retinal degeneration, obesity, structural and functional     defects of the central nervous system and the eyes, abnormal bone growth, abnormal sidedness     of internal organs and polydactyly. The goal of the study is to better understand the medical     complications of these disorders and identify characteristics that can help in the design of     new treatments....   "
170442|NCT00068237|"     RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may     protect the gland from side effects of radiation therapy and may prevent xerostomia (dry     mouth).      PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing     xerostomia in patients who are undergoing radiation therapy for head and neck cancer.   "
170443|NCT00068250|"     RATIONALE: Drugs used in chemotherapy such as methotrexate and temozolomide use different     ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies     such as rituximab can locate cancer cells and either kill them or deliver cancer-killing     substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to     damage cancer cells. Combining methotrexate, temozolomide, and rituximab with radiation     therapy may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide     when given together with methotrexate and rituximab followed by radiation therapy and to see     how well they work in treating patients with primary central nervous system lymphoma.   "
170921|NCT00075283|"     The overall goal of this study is to determine whether robotic-assisted gait training is     better than standard physical therapy treatments for improving walking ability in hemiparetic     stroke patients.   "
170444|NCT00068263|"     RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation     directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation     therapy in treating women who have undergone lumpectomy and axillary node dissection for     stage I or stage II breast cancer.   "
170445|NCT00068276|"     RATIONALE: Cholecalciferol (vitamin D) may improve quality of life by increasing blood     counts, decreasing fatigue, and improving other symptoms of myelodysplastic syndrome.      PURPOSE: This phase II trial is studying how well cholecalciferol works in treating patients     with myelodysplastic syndrome.   "
170446|NCT00068289|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary     for their growth.      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who     have recurrent or refractory extensive-stage small cell lung cancer that was previously     treated with platinum-based chemotherapy (such as cisplatin, carboplatin, or oxaliplatin).   "
170447|NCT00068302|"     RATIONALE: Drugs used in chemotherapy such as sirolimus use different ways to stop cancer     cells from dividing so they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of sirolimus in     treating young patients with relapsed or refractory acute leukemia or non-Hodgkin's lymphoma.   "
170529|NCT00069550|"     Rett syndrome (RTT) is a disorder in which the nervous system does not develop properly. RTT     generally affects girls, but there are some boys who have been diagnosed with RTT. Symptoms     of RTT include small brain size, poor language skills, repetitive hand movements, and     seizures. This study will evaluate the effectiveness of two drugs in treating the symptoms of     RTT.   "
170448|NCT00068315|"     This phase I trial is studying the side effects and best dose of bortezomib when given     together with fludarabine with or without rituximab in treating patients with relapsed or     refractory indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Bortezomib may     stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.     Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells     from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can     block cancer growth in different ways. Some block the ability of cancer cells to grow and     spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. Giving bortezomib together with fludarabine with or without rituximab may kill more     cancer cells.   "
170449|NCT00068328|"     RATIONALE: Studying how older women make treatment decisions and how these decisions affect     the outcome of treatment may help doctors plan more effective treatments and improve patient     quality of life.      PURPOSE: This clinical trial is studying how a patient's treatment preferences and decisions     about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast     cancer.   "
170450|NCT00068341|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways     to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as     trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances     to them without harming normal cells. It is not yet known whether docetaxel and carboplatin     are more effective with or without trastuzumab in treating breast cancer.      PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with     carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone     before surgery in treating women with locally advanced breast cancer.   "
170451|NCT00068367|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth.      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with     unresectable or metastatic malignant peripheral nerve sheath tumor.   "
170452|NCT00068380|"     Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth. This phase II trial is studying how well imatinib mesylate works in     treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal     junction cancer.   "
170453|NCT00068393|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin and gemcitabine, use different     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one     drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving doxorubicin together with     gemcitabine works in treating patients with locally recurrent or metastatic unresectable     renal cell carcinoma (kidney cancer).   "
170454|NCT00068406|"     RATIONALE: Drugs used in chemotherapy such as cisplatin use different ways to stop tumor     cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to     damage tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the     tumor so it can be removed during surgery.      PURPOSE: This phase II trial is studying how well giving radiation therapy together with     cisplatin followed by surgery works in treating patients with locally advanced cancer of the     vulva.   "
170455|NCT00068419|"     This phase II trial is studying how well giving sulindac together with tamoxifen works in     treating patients with desmoid tumor. Sulindac may stop the growth of cancer cells by     blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may     fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more     cancer cells.   "
170456|NCT00068432|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor     cells from dividing so they stop growing or die. Celecoxib may stop the growth of pancreatic     cancer by stopping blood flow to the tumor and blocking the enzymes necessary for tumor cell     growth. Combining gemcitabine with celecoxib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with celecoxib     works in treating patients with metastatic pancreatic cancer.   "
170457|NCT00068445|"     RATIONALE: Lamotrigine may be effective in reducing pain, numbness, tingling, and other     symptoms of peripheral neuropathy. It is not yet known whether lamotrigine is effective in     treating peripheral neuropathy caused by chemotherapy.      PURPOSE: This randomized phase III trial is studying how well lamotrigine works in reducing     pain, numbness, tingling, and other symptoms of peripheral neuropathy caused by chemotherapy     in patients with cancer.   "
170458|NCT00068458|"     RATIONALE: A home-based exercise and/or diet program may improve the quality of life of     breast cancer patients by preventing an increase in body fat and weight and a loss of lean     body tissue.      PURPOSE: This randomized phase II trial is studying the effectiveness of three home-based     diet and/or exercise programs in preventing weight gain and loss of muscle tissue in women     who are receiving chemotherapy for stage I, stage II, or stage IIIA breast cancer.   "
170459|NCT00068471|"     RATIONALE: Anidulafungin may be effective in preventing fungal infections in     immunocompromised children who have neutropenia.      PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how     well it works in preventing fungal infections in immunocompromised children with neutropenia     caused by chemotherapy or aplastic anemia.   "
170460|NCT00068484|"     Drugs used in chemotherapy such as topotecan use different ways to stop tumor cells from     dividing so they stop growing or die. Bortezomib may stop the growth of tumor cells by     blocking the enzymes necessary for tumor cell growth. Combining topotecan with bortezomib may     kill more tumor cells. This phase I trial is studying the side effects and best dose of     topotecan and bortezomib when given together in treating patients with metastatic or     unresectable cancer   "
170461|NCT00068497|"     This phase I trial is studying the side effects of gefitinib in treating patients with     metastatic or unresectable head and neck cancer or non-small cell lung cancer. Gefitinib may     stop the growth of cancer cells by blocking the enzymes necessary for their growth   "
170462|NCT00068510|"     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make     the body build an immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with malignant glioma.   "
201054|NCT00472680|"     The purpose of this study is to learn whether the amount of dietary protein can influence     bone health during the weight loss after weight loss surgery.   "
170463|NCT00068523|"     RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were     destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the     body's normal cells. Ultraviolet-B light therapy given before and after allogeneic stem cell     transplantation may help prevent this from happening.      PURPOSE: Clinical trial to study the effectiveness of combining ultraviolet-B light therapy     with allogeneic stem cell transplantation in treating patients who have hematologic     malignancies.   "
170464|NCT00068549|"     This phase I trial is studying the side effects and best dose of gemcitabine when given     together with radiation therapy and cisplatin in treating patients with cervical cancer that     has not spread beyond the pelvis. Radiation therapy uses high-energy x-rays to damage tumor     cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more     sensitive to radiation therapy and may kill more tumor cells.   "
170465|NCT00068575|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, use different ways     to stop tumor cells from dividing so they stop growing or die. Biological therapies such as     interferon alfa may interfere with the growth of the tumor cells and slow the growth of     cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining     chemotherapy and interferon alfa with radiation therapy after surgery may kill any remaining     tumor cells.      PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and     interferon alfa together with radiation therapy works in treating patients who have undergone     surgery for stage I, stage II, or stage III pancreatic cancer.   "
170466|NCT00068588|"     This phase II trial is studying how well giving GTI-2040 together with capecitabine works in     treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as     capecitabine, work in different ways to stop tumor cells from dividing so they stop growing     or die. GTI-2040 may help capecitabine kill more tumor cells by making them more sensitive to     the drug   "
170467|NCT00068601|"     RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether     ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women     receiving chemotherapy for breast cancer.      PURPOSE: This randomized phase III trial is studying how well giving goserelin together with     chemotherapy works compared with chemotherapy alone in preventing early menopause in women     with stage I, stage II, or stage IIIA breast cancer.   "
170468|NCT00068614|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women     who have breast cancer.   "
170469|NCT00068653|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the     tumor. Combining gefitinib with celecoxib may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with celecoxib in     treating patients who have non-small cell lung cancer that is refractory to platinum-based     chemotherapy (such as cisplatin or carboplatin).   "
170470|NCT00068666|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, use different ways to stop tumor     cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to     damage tumor cells. Combining temozolomide with radiation therapy may make the tumor cells     more sensitive to radiation therapy and kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation     therapy works in treating patients with stage IV malignant melanoma with measurable and     unresectable cancer limited to the central nervous system.   "
170471|NCT00068692|"     This randomized phase III trial is comparing the effectiveness of three adjuvant combination     chemotherapy regimens in treating patients who are receiving radiation therapy and     fluorouracil either before or after surgery for stage II or stage III rectal cancer. Drugs     used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, use     different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. It is not yet known which adjuvant     combination chemotherapy regimen is more effective in treating patients who are receiving     radiation therapy and fluorouracil either before or after surgery for rectal cancer   "
170472|NCT00068718|"     This phase I/II trial studies the side effects of donor lymphocyte infusion and to see how     well it works in treating patients with persistent, relapsed (disease that has returned), or     progressing cancer after donor hematopoietic cell transplantation. White blood cells from     donors may be able to kill cancer cells in patients with cancer that has come back     (recurrent) after a donor hematopoietic cell transplant.   "
170473|NCT00068731|"     RATIONALE: Lycopene, a substance found in tomatoes, may lower prostate-specific antigen (PSA)     levels and slow or prevent the development of prostate cancer.      PURPOSE: Phase II trial to study the effectiveness of lycopene in treating patients who have     asymptomatic metastatic prostate cancer and a rising PSA level.   "
170474|NCT00068744|"     RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether     radiation therapy and mitomycin are more effective when combined with fluorouracil or with     cisplatin in treating anal cancer .      PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and     mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and     cisplatin in treating patients with locally advanced anal cancer.   "
170475|NCT00068757|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. Lonafarnib may stop the growth of     tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such     as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing     substances to them without harming normal cells. Combining lonafarnib and trastuzumab with     paclitaxel may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when     given together with trastuzumab and paclitaxel in treating patients with     HER2/neu-overexpressing stage IIIB, stage IIIC, or stage IV breast cancer.   "
182059|NCT00219271|"     The objective of this study is to assess the effect Of zoledronic acid on circulating and     bone marrow-residing prostate cancer cells in patients with clinically localized prostate     cancer   "
170476|NCT00068770|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. It is not yet known whether the effectiveness of celecoxib in treating     glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and     undergoing radiation therapy.      PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are     receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed     glioblastoma multiforme.   "
170477|NCT00068783|"     This phase II trial is studying how well imatinib mesylate works in treating patients with     metastatic or unresectable Merkel cell cancer. Imatinib mesylate may stop the growth of tumor     cells by blocking the enzymes necessary for tumor cell growth   "
170478|NCT00068809|"     This study will determine if taking anti-HIV drugs 4 days a week will control HIV-1 viral     replication in patients who have already had at least 6 months of documented viral     suppression with full-time treatment. If this strategy is shown to be safe in this study, a     larger study will be undertaken to determine if the strategy can decrease overall drug     exposure and help young people adjust more easily to a chronic medication schedule.   "
170479|NCT00068822|"     Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the     spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of     fractures due to osteoporosis.   "
170480|NCT00068835|"     Dyslexia is a common reading disorder. Specialized instructional programs can improve reading     ability in children with dyslexia. This study will use functional magnetic resonance imaging     (fMRI) to examine changes in the brains of children who have taken part in these programs.   "
170481|NCT00068848|"     Women who choose to take birth control pills are currently instructed to begin taking the     pills at the end of a menstrual cycle. This creates a window of time between when the woman     is given the pills and when she begins taking them. Some women fail to begin taking the     pills, placing them at increased risk of pregnancy. This study will evaluate a new approach     to beginning birth control pills. Women will take the first pill in the doctor’s office     rather than waiting until the next menstrual cycle.   "
170482|NCT00068861|"     Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 10% of women.     The primary symptoms of PCOS are menstrual irregularities, increased body and facial hair,     acne, and infertility. This study will test a combination of medications in women with PCOS     to determine which works best to overcome infertility.   "
170483|NCT00068874|"     This study will evaluate a program designed to help African American adolescents with lupus     (systemic lupus erythematosus or SLE) cope with the disease.   "
170484|NCT00068887|"     There are several studies looking at how dietary fat is metabolized by humans. We give     special meals and collect blood, breath, urine and fat samples to study how people burn and     store dietary fat.   "
170485|NCT00068900|"     We will give intravenous fat molecules to help us understand how the fat that is released     from peoples fat cells is used. This will be done when people are eating, not eating and     walking.   "
170486|NCT00068913|"     Patients with the MELAS syndrome experience devastating mental impairment. This study will     evaluate the effectiveness of the drug dichloroacetate (DCA) to reduce the symptoms of MELAS.   "
170487|NCT00068926|"     This protocol will screen healthy normal volunteers for participation in studies of vaccines     under development at NIAID's Vaccine Research Center. Of interest are vaccines for:        -  Newly identified infectious diseases such as SARS.        -  Infectious diseases of concern as possible bioweapons, such as smallpox and Ebola virus        -  Emerging infectious diseases that are more widespread geographically than in the past,          such as West Nile virus        -  For preventing diseases such as tuberculosis and malaria.      Healthy normal volunteers between 18 and 70 years of age may be eligible for this protocol.     Screening begins about 1 to 6 months before the start of the vaccine study. Participants will     have a physical examination and health history, including questions about sexual activity and     drug use. Over the course of the screening visits, participants will be asked to give urine     and blood samples to test for various infections and other medical problems. Women capable of     getting pregnant will be given a pregnancy test. Women who are pregnant or breastfeeding will     not be enrolled in the study.      At the end of the screening, participants will be informed about which vaccines are currently     being tested in clinical trials for which they may be eligible. Once participants enroll in a     vaccine study, their participation in the screening protocol ends.   "
170488|NCT00068952|"     The purpose of this clinical trial is to study Edotecarin in patients with the brain tumor     glioblastoma multiforme (GBM) who have progression or first recurrence following initial     treatment with surgery, radiation and chemotherapy.   "
170489|NCT00068978|"     This study will evaluate a test designed to measure immune system responses to HIV and HIV     vaccines.   "
170490|NCT00068991|"     The purpose of this study is to determine whether two educational programs about HIV will     improve the quality of life of HIV infected people living in the rural villages of China. The     study will enroll HIV infected adult residents, influential community members, and other     community members of selected villages of Funan County or Yingzhou District, Anhui Province,     China.   "
170491|NCT00069004|"     The purpose of this study is to assess the prevalence of metabolic and physical abnormalities     in HIV infected (via mother-to-child transmission) and uninfected children and youth.     Metabolism, body composition, bone density, and other factors will be assessed in     relationship to participants' exposure to highly active antiretroviral therapy (HAART).   "
170492|NCT00069017|"     To compare, as a preliminary analysis, the effects of MEDI-522 versus placebo at 6 months on     disease activity (ACR20) and progression of structural joint damage.   "
170493|NCT00069030|"     This study will test the safety of and immune system response to a new HIV vaccine. The     vaccine in this study is made from HIV DNA produced in a laboratory. Only part of the virus's     DNA is used in the vaccine and the vaccine itself cannot cause HIV infection or AIDS. In     addition to HIV DNA, the vaccine contains interleukin-2 (IL-2) DNA fused to a portion of     immunoglobulin (Ig) DNA. IL-2 is a chemical that stimulates the immune system and may improve     response to the vaccine.      Study hypothesis: The IL-2/Ig plasmid will be very well tolerated in humans.   "
172727|NCT00094211|"     The purpose of this study is to investigate whether seniors living in neighborhoods that are     conducive to walking are more physically active than those living in neighborhoods that are     less conducive to walking.   "
170494|NCT00069056|"     This study will compare the side effects of two laser treatments for diabetic macular edema,     a common condition in patients with diabetes. In macular edema, blood vessels in the retina,     a thin layer of tissue that lines the back of the eye, become leaky and the retina swells.     The macula, the center part of the retina that is responsible for fine vision, may also swell     and cause vision loss. Traditional laser treatment (argon blue or green, or yellow) for     macular swelling, or edema, causes scarring that can expand and possibly lead to more loss of     vision. A different laser technique, the mild macular grid, uses lighter laser burns through     the macula and may be less damaging to the eye, but this is not known. This study will     compare the two techniques and the information on side effects will be used to design a     larger study of whether one laser is more effective than the other.      Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema may be     eligible for this study. Candidates will be screened with the following tests and procedures:        -  Medical history and physical examination.        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to          examine pupils, lens, retina and eye movements. The pupils will be dilated with drops          for this examination.        -  Blood tests to measure cholesterol levels, hemoglobin A1C (a measure of diabetes          control), and creatinine (measure of kidney function).        -  Eye photography to help evaluate the status of the retina and changes that may occur in          the future. Special photographs of the inside of the eye are taken using a camera that          flashes a bright light into the eye.        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina          are taken using a camera that flashes a blue light into the eye. The pictures show if          any dye has leaked from the vessels into the retina, indicating possible blood vessel          abnormality.        -  Optical coherence tomography to examine retinal thickness. The eye is examined with a          machine that produces cross-sectional pictures of the retina. These measurements will be          repeated during the study to determine whether retinal thickening is getting better,          worse, or staying the same.      Participants will be randomly assigned to one of the two laser therapies in the eye with     macula edema. (Patients with macular edema in both eyes will receive both treatments-one in     each eye.) For these procedures, eye drops are put in the eye to numb the surface, and a     contact lens is placed on the eye during the laser beam application. Several visits may be     required for additional laser treatments. The number of treatments depends on how well they     are working. Patients will return for follow-up visits 4, 8, and 12 months after the first     treatment, and then every year until year 3. During the follow-up visits, the response to     treatment will be evaluated with repeat tests of several of the screening exams.   "
170495|NCT00069069|"     This study will determine the maximum safe dose of the experimental drug E-selectin that can     be given to stroke patients. E-selectin causes white blood cells called lymphocytes to change     so that they prevent clots from forming in the vessels that supply blood to the brain. The     drug has been shown to be effective in animal models of stroke. This study will look at the     safety of using this experimental drug in nasal instillation form in patients who have had a     stroke or transient ischemic attack (TIA).      Patients 45 years of age or older who have had a recent stroke or TIA (30 to 120 days before     entering the study) due to a clot forming in a vessel that supplies blood to the brain may be     eligible for this study. They must be taking at least one medication to prevent clots, such     as coumadin, aspirin, ticlopidine, or others. Candidates will be screened with a physical and     neurological examination, blood and urine tests, electrocardiogram (EKG), echocardiogram     (ultrasound test of the heart), and magnetic resonance imaging (MRI) of the brain.      Participants will be randomly assigned to receive E-selectin at a dose level of 5, 15, or 50     micrograms or a placebo (nasal drops with no active ingredient). They will instill a small,     carefully premeasured amount (one dose) of fluid in their nose every other day for 10 days     (total of 5 doses). This course of treatment will be repeated two times at 3-week intervals.     Patients will be followed at 1 month and 3 months with a neurologic examination and blood and     urine tests. They will be contacted by phone, fax, or email in between these two visits.   "
170496|NCT00069082|"     This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in     the treatment of an episodic cluster headache period compared to placebo (medically inactive     substance which does not contain any active ingredients).   "
170497|NCT00069095|"     This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or     intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with     or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic     colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m^2 orally     [po] twice a day [bid] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin     + leucovorin + fluorouracil [5-FU] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on     Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).   "
170498|NCT00069108|"     This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv     fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients     previously treated for metastatic colorectal cancer. Patients will be randomized to receive     either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)     FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study     treatment is until disease progression, and the target sample size is 500+ individuals.   "
170499|NCT00069121|"     This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus     Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery     for colon cancer and no previous chemotherapy. Patients will be randomized to receive either     1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or     2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment     is until disease progression and the target sample size is 500+ individuals.   "
170526|NCT00069511|"     This is a multi-center study. Neither the study subjects nor the physicians will know what     treatment an individual subject is receiving. Subjects will be randomly assigned (like     flipping a coin) to one of five treatment groups. The treatment groups include four different     dosing groups of active study drug and one group of subjects who will receive placebo. A 12     week follow up period occurs after the 12 weeks of dosing. The study endpoint is a reduction     in Hepatitis C viral load.   "
179023|NCT00189813|"     This study will examine the efficacy, safety and tolerability of different oral dose of     YM060, 5-HT3 receptor antagonist, in patients with d-IBS.   "
170500|NCT00069134|"     It is believed that the organs of severely malnourished children malfunction because harmful     compounds called oxidants injure the tissues in these organs. In a healthy person oxidants     are made harmless because another compound called glutathione neutralizes them. Glutathione     is made from three amino acids that we get from the protein we eat in our food. We found that     malnourished children were not making enough glutathione because they lacked one of these     amino acids called cysteine. In this study we determine why malnourished children do not have     sufficient cysteine, and we will feed malnourished children a whey-based diet which is rich     in cysteine during their treatment to determine whether they will make more glutathione. This     in turn may make their organs recover faster. These findings will let us know whether     malnourished children can recover faster if they are given more cysteine during the early     phase of treatment.   "
172728|NCT00094237|"     To examine the association of subclinical hypothyroidism and risk of myocardial infarction     and stroke in a large prospective cohort of post-menopausal women.   "
170501|NCT00069160|"     The purpose of this study is three-fold: 1) to examine the ability of the experimental drug     tariquidar to improve chemotherapy results by blocking a protein (P-glycoprotein) on some     cancer cells that acts to pump out cancer drugs; 2) examine how tariquidar interacts with the     cancer drug docetaxel; and 3) evaluate the effectiveness of combination treatment with     tariquidar and docetaxel in treating patients with lung, ovarian, or cervical cancer.      Patients 18 years of age and older with recurrent or metastatic (spreading) lung, cervical,     or ovarian cancer who cannot benefit from any standard treatment may be eligible for this     study. Candidates will be screened with a medical history and physical examination; review of     pathology slides; blood and urine tests; imaging tests, including computed tomography (CT) or     magnetic resonance imaging (MRI) scans; chest x-ray, electrocardiogram (EKG); and possibly     echocardiogram.      Participants will undergo the following tests and procedures:      Blood draw. Blood is drawn before treatment begins to establish baseline levels for future     blood tests. Blood counts are done twice weekly after chemotherapy begins.      Central venous catheter placement. A plastic tube is put into a major vein in the chest. It     is used to give the study drugs or other medications, including antibiotics and blood     transfusions, if needed, and to withdraw blood samples. The line is usually placed under     local anesthesia in the radiology department or the operating room. It can stay in the body     for months or be removed after each treatment is completed.      Chemotherapy. Treatment cycles are 21 days. Both drugs are given on day 1 of each cycle.     First, tariquidar is given as a 30-minute infusion. One hour after the tariquidar infusion,     docetaxel is infused over 1 hour. (For the first cycle only, docetaxel is given in divided     doses one week apart and tariquidar is administered on either day 1 or day 8. The order of     tariquidar administration is randomized to generate optimal pharmacokinetic data. Patients     will be hospitalized for several days during this cycle to gather research data). The     tariquidar dose remains the same throughout the study. Docetaxel may be increased or     decreased from cycle to cycle, based on side effects.   "
170502|NCT00069173|"     Physical activity in adolescents is an important part of bone health. Good bone health in     adolescents can decrease the risk of osteoporosis. This study will evaluate a program     designed to increase the level of physical activity in adolescent girls.   "
170503|NCT00069186|"     The purpose of this study is to determine whether nine months of administration of creatine     monohydrate results in an increase in muscle strength in patients with amyotrophic lateral     sclerosis (ALS).   "
170504|NCT00069199|"     This study, conducted at the NIH Clinical Center and the University of Wisconsin University,     will compare measurements obtained using older and newer models of a machine called an     optical coherence tomography (OCT) scanner. This instrument uses a beam of light to measure     the thickness of the retina, the light-sensitive inner lining of the back of the eye. OCT     measurements will be done in multicenter clinical trials of new treatments for disorders that     cause vision loss, such as macular edema. Because some centers in these studies will use the     older OCT model and some the newer one, it is necessary to determine whether the two models     give comparable results.      People 18 years of age and older in the following categories may be eligible for this study:        -  People with diabetes, with or without macular edema;        -  People with other retinal disease, such as uveitis or vein occlusion in the retina;        -  People with no history of eye disease who have a normal retina.      Participants will have the following tests and procedures:        -  Eye examination to assess vision and eye pressure and to evaluate the retina. The pupils          are dilated with drops for this examination.        -  Stereoscopic color fundus photography to examine the back of the eye. Eye drops are used          to enlarge the size of the pupils to allow for a through examination and photographs of          the eye using a special camera that flashes a bright light into the eye.        -  OCT to measure retinal thickness. For this procedure, the subject sits in front of a          small screen and looks at a target in the center of the screen while a dim red light          moves across the subject's retina. This test is done first with one model of the OCT          scanner, then the other. Finally, the test is repeated in both eyes with whichever model          was used first.      Patients who are being treated for macular edema will repeat the same tests at their 3-month     visits.   "
170505|NCT00069212|"     This study will evaluate brain changes and psychological characteristics of people who are     resilient to trauma. It will examine and compare responses in three categories of subjects:     1) people who have been exposed to a significant traumatic event and suffer symptoms of     post-traumatic stress disorder (PTSD) severe enough to interfere with their ability to     function; 2) people who have been exposed to a significant traumatic event and do not suffer     PTSD symptoms severe enough to interfere with their ability to function; and 3) people who     have never been exposed to a significant traumatic event. Most people who are exposed to     trauma recover well from the adversity. Some may even benefit from it by, for example,     gaining greater self-confidence of strengthening personal relationships. Others, however,     develop PTSD and may have repeated thoughts, images, and dreams of the trauma; feel upset     when reminded of the traumatic event; avoid places or people that remind them of the trauma;     feel detached from others; have difficulty sleeping and concentrating; or startle easily.      People in the three categories listed above may be eligible for this study. Candidates will     be screened with a medical and psychiatric interview, evaluation of emotional intelligence     (sensitivity to feelings of others), physical examination, electrocardiogram (EKG) and blood     tests.      Participants will undergo the following additional tests and procedures:        -  24-hour urine collection and three urine drug screens over the course of the study.        -  Saliva collection every 2 hours on the day of the urine collection.        -  Magnetic resonance imaging (MRI) scans of the brain: Subjects will have three MRI          scanning sessions to show brain structure and changes in blood flow in different regions          of the brain that are responsible for emotion. MRI uses a strong magnetic field and          radio waves to produce images of body tissues. During the scan, the subject lies on a          table in a narrow cylinder containing a magnetic field and may wear earplugs to muffle          loud sounds that occur during the scanning process. While in the scanner, the subject is          shown pictures of faces, houses, or words and performs tasks that involve making          decisions about the pictures Subjects are also shown pleasant, unpleasant, and neutral          pictures; and they are asked to play two games of chance - one that evaluates social          cooperation; the other evaluating decision-making. Heart rate, blood pressure and          respiration are measured during the scans.        -  Neuropsychological testing: These tests are designed to evaluate memory, learning,          attention and concentration, and naming.        -  Aversive conditioning: This procedure examines how the body reacts to unpleasant          stimuli, such as a mildly unpleasant electrical stimulation to the wrist or a loud          sound, over time. During the test, heart rate, electrodermal activity (sweat),          respiration, finger pulse volume, and eyeblink responses will be measured. A small blood          sample will be drawn every 5 minutes to evaluate plasma levels of various stress          hormones, including cortisol, neuropeptide Y, norepinephrine, and others.        -  Genetic and biological testing: Patients who agree to genetic testing will have a blood          sample drawn for DNA studies to better understand the biology and pharmacology of PTSD.   "
170506|NCT00069225|"     This study, conducted at the University of Pennsylvania and at the National Institutes of     Health in Bethesda, Maryland, will examine deficits in brain structure and function in people     exposed to trauma who developed post-traumatic stress disorder (PTSD) to see if these     deficits change after treatment. It also will investigate whether there is a genetic     susceptibility to PTSD.      Candidates 18 years of age and older in the following categories will be included in this     study: 1) women who have PTSD of at least 1 year's duration following sexual or non-sexual     assault; 2) healthy women (controls) who were previously assaulted but did not develop PTSD;     and 3) healthy women (controls) who were never traumatized. Candidates will be screened with     a medical history and physical examination, psychiatric evaluation, electrocardiogram (EKG),     and routine blood and urine tests.      Women with PTSD will be assigned to receive either: 1) 12 weeks of cognitive behavioral     psychotherapy either immediately upon enrollment or after a 3-month waiting period; or 2) 10     weeks of drug treatment with paroxetine (Paxil® (Registered Trademark)). Patients will be     evaluated before and after treatment with the procedures outlined below. Control subjects     will undergo the same procedures, also with a 10- to 12-week interval between evaluations.        -  Neuropsychological testing: Subjects will take paper and pencil and computer tests to          evaluate memory, learning, attention and concentration, vocabulary and naming.        -  Magnetic resonance imaging (MRI): Subjects will have MRI scans of the brain to examine          brain structure and blood flow while they perform two tasks. In the first task, they          will be shown a series of faces and asked to press one button for a male face and          another button for a female face. In the second task they will hear loud noises and see          colored squares. During the scan, subjects lie on a bed that slides into a narrow tunnel          (the scanner). They will wear a headset to block the noise of the scanner and through          which they will receive instructions for the tasks. Heart rate and skin conductance          (sweating) will be measured during the scan to evaluate physiologic changes in response          to the tasks.        -  Eyeblink air puff test: Subjects will hear tones and will have a light puff of air          delivered to the eye. Changes in heart rate, sweat, and eyeblink will be measured with          electrodes taped to the skin on two fingers, on each side of the rib cage, and under one          eye.        -  Potential air puff delivery: This experiment has three parts. During each of the three          parts of this experiment, subjects will see colored lights and may or may not receive a          puff of air to the neck. Before each part they will be told that they will, will not, or          may receive an air puff to the neck. Each part will be repeated several times. During          the test, electrodes will be taped to the arms and chest to monitor skin conductance and          heart rate responses.        -  Blood draw for genetic evaluation: Subjects' DNA will be examined to try to determine if          the risk of developing PTSD is inherited. The DNA will be examined for cortisol receptor          gene evaluation, to see if a form of this gene is found more often in patients with PTSD          than in healthy controls. The receptor for cortisol determines the activity of the          stress hormone cortisol, and genetic variations in the structure of this receptor may be          related to vulnerability to PTSD.      Patients taking paroxetine will be offered up to 3 months of additional drug therapy     following completion of the study and will be offered participation in other NIH studies for     evaluation and treatment of PTSD.   "
170507|NCT00069238|"     Background:      The paradigm of combining therapeutic agents with non-overlapping toxicities for the     treatment of malignancy produces clinical remissions and cures in a number of tumor types.      A new class of agents, humanized and chimerized monoclonal antibodies, typically have little     or no hematopoietic toxicity and can be readily combined with full doses of cytotoxic     chemotherapy. It has become clear that in certain lymphomas and breast cancers, the     combination of monoclonal antibodies and chemotherapy improves response rate and the quality     of the response compared with that achieved by treatment with either agent alone.      The clinical outcome for patients with T-cell non-Hodgkins lymphoma is significantly inferior     to the outcome of patients with B-cell non-Hodgkin s lymphoma. In most reports less than 20%     of patients with T cell lymphoid malignancies remain free of disease at 5 years.      Objectives:      Determine the toxicity of Alemtuzumab and etoposide, prednisone, vincristine,     cyclophosphamide, doxorubicin (EPOCH) chemotherapy in untreated cluster of differentiation 52     (CD52)-expressing T and natural killer (NK) lymphoid malignancies.      Determine the maximum tolerated dose of Alemtuzumab administered in combination with EPOCH     chemotherapy.      Determine in a preliminary fashion the anti-tumor activity of the combination of Alemtuzumab     and EPOCH chemotherapy.      Eligibility:      CD52-expressing lymphoid malignancy.      Patients with chemotherapy naive aggressive T & NK lymphomas. Patients with alk-positive     anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible.      Age greater than or equal to 17 years.      Adequate organ function, unless impairment due to respective organ involvement by tumor.      No active symptomatic ischemic heart disease, myocardial infarction or congestive heart.     failure within the past year.      Human immunodeficiency virus (HIV) negative.      Not pregnant or nursing.      Design:      Three dose levels of Alemtuzumab will be evaluated to determine the toxicity profile and in a     preliminary fashion the antitumor activity of the combination with Dose-Adjusted EPOCH.      Three dose levels of Alemtuzumab will be explored, in cohorts of three to six patients each.     Patients will receive either 30, 60, or 90 mg of Alemtuzumab on day 1 of therapy, followed by     dose-adjusted EPOCH chemotherapy days 1-5.   "
170508|NCT00069251|"     The purpose of this study is to assess the efficacy and safety of bupropion in reducing     methamphetamine use in subjects with methamphetamine dependence   "
170509|NCT00069264|"     To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that     have progressed following standard therapy or for which no standard therapy exists.   "
170510|NCT00069277|"     The malignancies (advanced solid tumors) that have been chosen for evaluation of E7389 are     those where E7389 has demonstrated significant pre-clinical anti-tumor activity, both in     vitro and in vivo. The ultimate goal is to demonstrate the clinical activity of E7389 in the     treatment of these, and potentially other, tumor types.   "
170511|NCT00069303|"     This study will examine how West Nile virus (WNV) infection affects the body. Some people     infected with WNV have no symptoms. In others, symptoms may vary from fever and headache to a     polio-like syndrome with paralysis, to coma and brain changes like those of a stroke. Many     patients recover with no lasting effects, while a few can have long-lasting neurological     damage or may die. This study will collect clinical, laboratory, diagnostic, and radiographic     information on people thought to have WNV to better understand the disease.      Patients 18 years of age and older diagnosed with or suspected of having West Nile virus     infection may be eligible for this study. Patients will be hospitalized until they are well     enough to go home and will undergo the following tests and procedures:        -  Medical history and physical examination: A thorough history and physical examination          will be done on the first day of the study. Then, brief physical exams, including          measures of blood pressure, heart rate, breathing rate, and temperature, will be done          during each day of hospitalization and at every follow-up clinic visit (at 2 weeks and          at 1, 3, and 6 months).        -  Blood tests: Blood samples will be collected on the first day of the study, at day 7, at          hospital discharge, and at follow-up visits to determine if virus remains in the blood          and how it is affecting the body.        -  Magnetic resonance imaging (MRI): MRI scans will be done within 72 hours of beginning          the study and 1 month after that. This test uses a strong magnetic field and radio waves          to produce images of the brain that might show abnormalities in the brains of patients          with WNV and reveal whether the abnormalities can predict how an individual will          recover. For the procedure, the patient lies on a table that is moved into the narrow          tunnel-like scanner. During the procedure, a contrast agent that brightens the images is          injected through a catheter placed in an arm vein.        -  Neurological examination and neurological function tests: Participants will be tested to          see if the West Nile virus has affected their thinking and ability to perform normal          daily activities. These tests will be done at the start of the study, on days 3 and 7          (also days 2, 4, 5, and 6 if patients are still in the hospital), at discharge, and at          follow-up visits. The tests involve answering a number of questions and performing          simple tasks, such as squeezing a hand or lifting a foot.        -  Patients who develop weakness in their arms or legs will also have the following          studies:             1. Electromyography (EMG) to study the electrical activity of the muscle. For this               test, needles are placed into a muscle to record the electrical activity at that               site.             2. Nerve conduction studies to measure how well the nerves are working. A small charge               of electricity is delivered to a nerve in the affected limb, triggering a muscle to               tighten or bend. Small wire electrodes are attached to the skin to measure the time               is takes for the nerve to move the electrical current from one part of the limb to               another.             3. Spinal MRI to see if the virus is affecting the spinal cord.      Results of other tests done by the patient's local doctor (such as lumbar puncture,     electroencephalogram, x-rays, etc.) will be requested. If a lumbar puncture is done, a small     amount of cerebrospinal fluid will be requested for testing for WNV.   "
170527|NCT00069524|"     The primary goal of this study is to evaluate the short-term safety and potential efficacy of     oyster mushrooms (Pleurotus ostreatus) for treatment of hyperlipidemia in HIV-infected     patients who are taking Kaletra, a protease inhibitor (PI) that is commonly used in highly     active antiretroviral therapy (HAART).   "
170984|NCT00076206|"     The primary objective of this study is to compare the therapeutic response and safety of 3     oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA)     who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.   "
170530|NCT00069563|"     Children from low socioeconomic levels are more likely to have a mental disorder. However,     they are less likely to receive appropriate treatment for that disorder than are children at     higher socioeconomic levels. This study will evaluate a program designed to improve mental     health services for these children through public school systems.   "
170531|NCT00069576|"     Gestational diabetes mellitus (GDM) is a type of diabetes (high blood sugar) that occurs in     pregnant women. This study will determine whether treating pregnant women who have mild GDM     improves the health of their babies. The follow-up study will examine whether factors during     the previous pregnancy (such as blood sugar during pregnancy) are associated with the woman     and her child's health 4-9 years later.   "
170512|NCT00069316|"     Investigators will assess whether Omr-IgG-am(Trademark), an intravenous immunoglobulin (IVIg)     containing antibodies specific for West Nile virus (WNV), is safe and well-tolerated in     patients with suspected or laboratory diagnosed WNV disease. An initial estimation of     efficacy will also be made.      This Phase I/II study will enroll hospitalized adults with a presumptive diagnosis of West     Nile encephalitis and/or myelitis or those with a positive laboratory test for diagnosis of     WNV infection who are at high risk for progressing to severe neurologic disease based on age     or immunosuppression. Patients will be randomized in blocks of five to receive either     Omr-IgG-am(Trademark), Polygam(Registered Trademark) S/D (IVIG containing minimal anti-WNV     antibodies) or normal saline in a ratio of 3:1:1. Patients and investigators will be blinded     to treatment assignments.      Patients will receive a single intravenous dose of study medication or one of two placebos.     The study participants will receive 0.5 grams/kg of Omr-IgG-am(Trademark) or     Polygam(Registered Trademark) S/D or a comparable volume of normal saline. All patients will     be followed for safety, natural history endpoints, and efficacy. A subset of patients will     have pharmacokinetic measurements of specific anti- WNV antibodies assessed following     treatment.      The primary endpoints are safety and tolerability following Omr-IgG-am(Trademark)     administration.      Secondary endpoints include pharmacokinetics of specific anti-WNV antibodies, mortality in     confirmed WNV positive patients, and the combination of mortality and functional status at     three months in both confirmed WNV-infected patients and all patients by intention to treat.     This combined endpoint will be measured using four standardized measures of cognitive and     functional status: the Barthel Index; the Modified Rankin Scale; the Glasgow Outcome Score;     and the Modified Mini-Mental Status Examination. A comparison of outcomes will be made for     the group receiving Omr-IgG-am(Trademark) versus those receiving either placebo, and between     the two placebo groups. Other secondary endpoints include the proportion of patients in each     group returning to pre-morbid baseline and each subject's improvement at 3 months as compared     to that subject's worst (of any previous) evaluation.      Natural history endpoints will also be assessed. They will include the duration of intensive     care unit (ICU) and hospital stay, development and persistence of WNV-specific IgG and IgM     antibodies, combined functional score and mortality at 3 months between the group with     encephalitis and/or myelitis at baseline versus the group with a positive WNV test only,     outcomes in patients treated late in coma and correlation of outcome with time-to-treatment     following symptom onset.   "
170513|NCT00069329|"     This study will evaluate the safety and effectiveness of anakinra (Kineret) for treating     patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic     infantile neurological, cutaneous and arthropathy (CINCA) syndrome. This disease can cause     rash, joint deformities, brain inflammation, eye problems, and learning difficulties. Immune     suppressing medicines commonly used to treat other pediatric rheumatologic diseases do not     suppress NOMID symptoms and, if used long-term and in high doses, can cause harmful side     effects. Anakinra, approved by The Food and Drug Administration for treating rheumatoid     arthritis in adults, blocks a substance called IL-1 that may be an important factor in     causing the inflammation in NOMID.   "
170514|NCT00069342|"     This study will explore the diverse health beliefs and behaviors among minority patients with     rheumatic diseases. These diseases may cause joint pain, stiffness or swelling. Some can     involve bones, muscles, tendons or ligaments. Some cause abnormalities of the immune     system-the body's defense against disease. Some rheumatic diseases are painful or deforming     and some can be life-threatening. Many rheumatic diseases occur more often and more severely     in certain minority communities. This study will explore psychosocial and cultural factors     related to rheumatic disease in minorities.      Patients enrolled in the NIAMS protocol Natural History or Rheumatic Disease in Minority     Communities (protocol #01-AR-0227) may participate in this study. Participants will be     evaluated at the NIAMS Community Health Center at the Upper Cardozo Health Center in     Washington, D.C.      Participants will be interviewed about individual and community health behavior, and health     beliefs about rheumatic disease and its effects on several areas of their life, including     mood and physical activity. The interview will be in one of the following formats: 1)     in-depth cognitive interview, 2) focus group, or 3) face-to-face interview, as follows:      In-Depth Cognitive Interview      Participants take part in a one-time interview conducted by one investigator, observed by     another, and tape recorded. The interview lasts from 1 to 2 hours.      Focus Groups      Participants take part in a group interview of from 6 to 10 people during a one-time     tape-recorded session that lasts from 2 to 2-1/2 hours. The group discussion is led by a     moderator and a facilitator, who takes notes and makes observations.      Face-to Face Interview      Participants are interviewed twice - first upon enrollment at the NIAMS Community Health     Center and again after 6 months' follow-up at the Center.   "
170515|NCT00069355|"     This 10-week study will examine whether propranolol, a medication that blocks the activity of     the stress hormones adrenaline and noradrenaline, can relieve acute stress disorder (ASD) and     symptoms from persisting long-term. ASD is a condition that some people develop soon after     exposure to trauma. They may be anxious, depressed, have trouble sleeping, startle easily,     have difficulties concentrating, and feel as though the event is happening again. Propranolol     has been used for many years to treat high blood pressure and heart disease, and has been     found useful in treating anxiety states such as social phobia and migraine.      Men and women between 18 and 65 years of age who were recently exposed to trauma (between 1     and 3 weeks of evaluation in this study) may be eligible for this study. Candidates must be     diagnosed with ASD and must have been mentally healthy before the traumatic event. They will     be screened for the study with a medical and psychiatric interview, physical examination,     electrocardiogram (EKG), and blood and urine tests.      Participants will be evaluated with the following procedures:        -  Neuropsychological tests using pen-and-paper and computer tests to evaluate cognitive          function, particularly memory, learning, attention and concentration, and vocabulary and          naming.        -  Emotion-related performance tasks to determine if the study medication can weaken          emotionally arousing information by blocking the activity of adrenaline and          noradrenaline. Subjects perform emotion-related and neutral tasks, such as looking at          pictures with neutral, pleasant, or unpleasant content, both before and after treatment          with the study medication (see below).        -  Traumatic script exposure: Subjects recount the traumatic event that caused them to          develop ASD. The description is summarized, recorded, and played back to the subject.          During the playback, physiological responses, such as heart rate and skin conductance          (sweating), are recorded using electrodes taped to the hand and chest.        -  Fear conditioning to evaluate the response to an unpleasant stimulus: Several mild          electrical shocks are delivered to the wrists while the subject looks at colored          squares. Heart rate and skin conductance are measured.        -  Magnetic resonance imaging (MRI) to examine brain structure. The subject lies on a table          that is moved into the MRI scanner (a narrow cylinder containing a strong magnetic          field) and must remain still during the actual scanning. Earplugs are worn to muffle          loud noises caused by electrical switching of radio frequency circuits used in the          scanning process.      After the evaluation, participants are randomly assigned to receive either propranolol or     placebo (a look-alike pill with no active ingredient) for 8 weeks During this time they are     seen by a doctor once a week for 4 weeks and then once every other week for the rest of the     study. At the end of the 8-week treatment period, participants undergo the same evaluation     they had before beginning treatment (see above). The decision to continue treatment will then     be decided based on the individual's clinical condition and whether he or she received     propranolol or placebo.   "
170516|NCT00069368|"     This study consists of two studies with overlapping cohorts. One is a follow up     epidemiological study of urinary incontinence, the other is a case control study of lower     urinary tract dysfunction in women with diabetes.      Study One:      Subjects for the study will be a retrospective cohort of 2100 middle-aged and older women     from a large health maintenance organization who have participated in the Reproductive Risk     Factor for Incontinence Study at Kaiser (RRISK). The RRISK I study assembled a retrospective     cohort of long-term female Kaiser Permanente members to determine the association between     specific childbirth events, hysterectomy, hormone use and urinary incontinence later in life.     The study also provides descriptive information on urinary incontinence by type, age,     ethnicity, severity and age of onset.      Study Two:      Women with diabetes have a 30-70% increased risk of lower urinary tract dysfunction,     including lower urinary tract symptoms, urinary incontinence, and ultimately bladder     cystopathy. This sudy investigates the natural history, risk factors, and possible mechanisms     of lower urinary tract dysfunction and infection among women with type 2 diabetes as compared     to women without diabetes.   "
170517|NCT00069381|"     This study will compare one- and two-component treatments in women with post-traumatic stress     disorder (PTSD).   "
170518|NCT00069407|"     This study will compare the antidepressant benefits and cognitive side effects of three     different types of electroconvulsive therapy (ECT) in people with unipolar or bipolar     depression.   "
170519|NCT00069420|"     This study will evaluate the effectiveness of cognitive motivational behavior therapy (CMBT)     in treating pathological gamblers.   "
170520|NCT00069433|"     This study will determine the effectiveness of skills training in people with schizophrenia     and the applicability of the acquired skills in the real world.   "
170521|NCT00069446|"     This is a Phase I, double blind, randomized, placebo-controlled study that will enroll     approximately 50 adult subjects with Type 1 or Type 2 diabetes mellitus and chronic, diabetic     foot ulcers. The study will be conducted at approximately 12 investigational sites in the     United States.   "
170522|NCT00069459|"     A placebo controlled study evaluating the effectiveness of medication in preventing winter     depressive episodes in patients with a history of Seasonal Affective Disorder   "
170523|NCT00069472|"     Many genes are thought to contribute to rheumatoid arthritis (RA). This study will attempt to     identify genes that may contribute to RA.   "
170524|NCT00069485|"     The immune systems of some individuals may be capable of resisting HIV infection. These     individuals do not appear to be infected with HIV despite multiple sexual encounters with HIV     infected partners. This study will examine the immune systems of these individuals to     determine what factors are responsible for their ability to resist HIV infection.      Study hypothesis: Some long-term, multiply-exposed seronegative persons have relative     resistance to HIV infection maintained by T cell responses.   "
170525|NCT00069498|"     The lining of the gastrointestinal tract contains specialized lymphoid tissue that is part of     the immune system. Like other parts of the immune system, HIV attacks this lymphoid tissue.     This study will evaluate the effect of an anti-inflammatory drug on the lymphoid tissue in     the gastrointestinal tracts of people with HIV.   "
170533|NCT00069602|"     Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes     mellitus. The purpose of this study was to determine whether two FDA-approved continuous     glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM     Biographer (GW2B), are sufficiently accurate to use in future studies to characterize glucose     levels in children.   "
170534|NCT00069615|"     Devices such as the GlucoWatch G2 Biographer (GW2B), which constantly measure blood sugar     levels, may improve the treatment of Type 1 diabetes mellitus in children. This study     evaluated the GW2B when used by children in their homes.   "
170535|NCT00069628|"     This study will evaluate the safety and effectiveness of a continuous glucose monitor in     children with Type 1 diabetes mellitus (T1DM).   "
170536|NCT00069641|"     The purpose of this study is to determine whether the administration of iduronate-2-sulfatase     enzyme in a weekly or every other week therapy frequency is safe and efficacious in patients     with MPS II.   "
170537|NCT00069654|"     This study will determine whether dietary nitrates and nitrites can produce nitric oxide in     the body and dilate blood vessels in patients with coronary artery disease. Nitric oxide is     normally made by endothelial cells that line blood vessels. It plays an important role in     maintaining the normal function of arteries by keeping them open and preventing damage from     substances such as cholesterol in the blood stream. Coronary artery disease is caused by     atherosclerosis (hardening of the arteries or build-up of cholesterol and scar tissue within     the walls of the arteries). Once arteries become clogged, the ability of the endothelium to     produce nitric oxide diminishes considerably and may speed up the disease process, leading to     shortness of breath, chest pain, and an increased risk of heart attack or stroke.      Patients 21 years of age and older with coronary artery disease may be eligible for this     study. Participants will have a medical history and physical examination, electrocardiogram     (recording of the electrical activity of the heart), echocardiogram (ultrasound test of the     heart), treadmill exercise stress test (see below), and will meet with a dietitian. They will     be hospitalized at the NIH Clinical Center on two occasions. For 1 week before each     admission, they will follow a diet prescribed by an NIH nutritionist. The diet before one     admission will be high in nitrates and nitrites, and the diet before the other admission will     be low in nitrates and nitrites. Each admission will last 4 days, during which participants     will undergo the following tests:        -  Forearm blood flow study: Small tubes are placed in the artery and vein at the inside of          the elbow of the dominant arm (right- or left-handed) and a small tube is placed in a          vein of the other arm. The tubes are used for infusing saline (salt water) and for          drawing blood samples. A pressure cuff is placed around the upper part of the dominant          arm, and a rubber band device called a strain gauge is also placed around the arm to          measure blood flow. When the cuff is inflated, blood flows into the arm, stretching the          strain gauge at a rate proportional to the flow. Maximum grip-strength of the dominant          arm is measured with a dynamometer. Forearm blood flow is measured and blood samples are          drawn at the following times: 20 minutes after the tubes are placed; during a hand-grip          exercise; and 4 minutes after the exercise is completed.        -  Brachial artery reactivity study: This test measures h...   "
170538|NCT00069680|"     This study will identify and characterize the gene or genes responsible for Gray Platelet     syndrome (GPS). Platelets are small blood cells that stick on injured blood vessels to form a     plug and stop bleeding. When a blood vessel is injured (like a cut on a finger), platelets     release the proteins stored in their sacs to help form a blood clot. Patients with GPS bleed     longer than other people because their platelets lack some of these protein-carrying sacs.     Platelets without sacs look pale gray under the microscope rather than pink, giving the     syndrome its name. Except for rare patients with severe hemorrhage, the bleeding tendency in     GPS is usually mild to moderate, with patients experiencing easy bruising, nosebleeds, and,     in women, excessive menstrual bleeding.      Patients with GPS and members of their family with GPS may be eligible for this study.     Participants will provide a personal and family medical history and will have blood drawn.     About 1 to 2 tablespoons of blood will be drawn in adults, and about 1 teaspoon in children.     The blood will be analyzed for genes that cause GPS   "
170539|NCT00069693|"     This study will conduct tests with patients with primary chronic orthostatic intolerance     (COI) to learn more about this disorder of the autonomic nervous system.      Healthy normal volunteers and patients 18 years of age and older with COI may be eligible for     this study. Participants undergo one or more of the following tests and procedures:        -  Blood studies, including arterial catheter insertion to measure blood pressure and          collect arterial blood samples, blood flow studies using sensors applied to the skin and          a pressure cuff around a limb, blood volume studies using injection of radioactively          labeled human serum albumin and gene studies to look for genetic abnormalities          associated with certain proteins.        -  Imaging studies, including CT scan of the adrenal glands, heart ultrasound, and PET          scanning.        -  Electrocardiogram        -  Microdialysis to measures levels of chemicals in the body fluid of certain tissues. A          thin tube is inserted into the skin and a solution is passed through it. Chemicals in          the body tissues enter the solution in the tube. The solution is collected and the          chemical levels are measured.        -  Neck suction. Neck suction is applied to test a reflex the brain uses to regulate blood          pressure.        -  Perometry. Limb volume is measured using an infrared light that moves up the limb.        -  Quantitative sudomotor axon reflex test to evaluate an aspect of autonomic nervous          system function. A small amount of a brain chemical (acetylcholine) is applied to the          skin with a tiny amount of electricity, and the sweat in a nearby patch of skin is          measured.        -  Skin electrical conduction test using sensors on the skin to measure sweat production.        -  Skin and core temperature measurements using sensors on the skin and in the ear canal.        -  Tilt table test. The subject lies on a table, secured with straps around the chest and          legs. Sensors are placed on the arms and chest to monitor blood pressure, pulse rate,          and heart rhythm. A catheter is placed in a vein in each arm to collect blood samples          and give drugs. Another catheter is placed in an artery to draw blood and monitor blood          pressure. The subject is given an infusion of norepinephrine and epinephrine, and          baseline measures and blood samples are taken. The table is tilted upright and more          measurements and blood samples are taken at intervals for up to 30 minutes. The table is          returned to a horizontal position and additional measurements and samples may be taken.      Drugs may be administered during the tests, including acetylcholine, epinephrine, and     norepinephrine, radioactive chemicals used in imaging studies, and drugs that affect blood     vessels, heart rate, and force of heart contractions.   "
170543|NCT00069745|"     PURPOSE:      The SPARC trial is designed to compare the combination of the investigational oral cytotoxic     drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in     patients with hormone-refractory prostate cancer (HRPC).      TARGET PATIENT POPULATION:      The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC)     and whose disease has progressed after treatment with one chemotherapy regimen. Please refer     to the Eligibility Criteria page for the key inclusion and exclusion criteria.      WHAT IS SATRAPLATIN:      Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based     drugs have been clinically proven to be one of the most effective classes of anticancer     therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given     orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy     against prostate cancer in a randomized trial.      RATIONALE:      There are currently no approved chemotherapy drugs for the second line treatment of     hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in     Europe, the combination of satraplatin and prednisone had superior activity compared to     prednisone alone, for the treatment of HRPC patients who had not previously been treated with     chemotherapy   "
170599|NCT00070096|"     RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with     metastatic germ cell tumors that are refractory to cisplatin.   "
182658|NCT00233558|"     The purpose of the study is to evaluate the clinical efficacy of scheduled versus free     reduction of steroid treatment in patients with active RA treated with adalimumab + MTX   "
170544|NCT00069758|"     Summary: As this is an open label study, all patients will receive SDX-105 by 30-60 minute     intravenous infusion on day 1 and day 2. Treatment will repeat every 21 days. Treatment can     continue for up to one year in the absence of disease progression or unacceptable toxicity.     Patients will be followed until disease progression.      Rationale: Drugs used in chemotherapy, such as SDX-105, use different ways to stop tumor     cells from dividing so they stop growing or die.      Purpose: This study will evaluate the effectiveness and safety in non-Hodgkin's lymphoma in     patients who are refractory to Rituxan.   "
170545|NCT00069784|"     The primary objectives of the ORIGIN study were:        -  To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular          morbidity and/or mortality in people at high risk for vascular disease with either          Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2          diabetes;        -  To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people          with IFG, IGT or early type 2 diabetes.      The secondary objectives of the insulin glargine study were to determine if insulin     glargine-mediated normoglycemia can reduce:        -  total mortality (all causes);        -  the risk of diabetic microvascular outcomes;        -  the rate of progression of IGT or IFG to type 2 diabetes.   "
170546|NCT00069797|"     To examine whether the prevalence of subclinical coronary and aortic atherosclerotic disease     is different among Japanese in Japan, Japanese in Hawaii, and black and white Americans.   "
170547|NCT00069810|"     The purpose of this study is to determine how the progressive loss of kidney function     influences cardiovascular disease.   "
170548|NCT00069823|"     The purpose of this study is to determine if subjects with symptomatic asthma who are     assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer     asthma attacks than similar subjects assigned to placebo treatment.   "
170549|NCT00069836|"     This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in     combination with insulin in improving the control of blood sugar when compared with taking     insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both     AVANDIA and metformin are medicines which are individually licensed for the treatment of type     II diabetes mellitus. Because they act in different ways, it is thought that combining them     may give an increased benefit of treating diabetes and reducing blood sugar.   "
170550|NCT00069849|"     The purpose of this study is to compare the safety and efficacy of 2 mg, 4 mg, and 20 mg of     ABT-089 BID to placebo in adults with Alzheimer's disease.   "
170551|NCT00069862|"     A clinical trial designed to compare the safety and iron excretion properties of     desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.   "
170552|NCT00069875|"     The purpose of this study is to determine the effectiveness and side effects of LY293111     given in combination with gemcitabine and cisplatin in patients with non-small cell lung     cancer.   "
170553|NCT00069888|"     This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk     of relapse in patients with prostate cancer who have had their prostate removed by surgery,     but are at high risk of their cancer recurring. During the trial, doctors will also closely     monitor patients for side effects of the chemotherapy.      Docetaxel is a chemotherapy drug that prevents tumor cells from dividing, so they stop     growing or die. Doctors use docetaxel to treat lung and breast cancer, and studies show it     can help shrink tumors in some patients with prostate cancer that has spread to other parts     of their bodies. The researchers conducting this study want to determine if docetaxel also     helps reduce the likelihood of prostate cancer returning after surgery has removed the     original tumor.      All of the study participants will receive up to 18 doses of docetaxel, each administered     through a needle inserted into a vein. Each round of treatment will consist of 30-minute,     weekly infusions for three consecutive weeks, followed by one week with no chemotherapy.     Before and after the chemotherapy, patients will take dexamethasone, an oral steroid that     reduces the risk of an allergic reaction to the medication. If the side effects of the     treatment become too intense, doctors may modify, delay, or even stop chemotherapy during the     trial.   "
170554|NCT00069901|"     The purpose of this study is to evaluate the safety and efficacy of CT-2103     (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients     with Stage III or IV ovarian or primary peritoneal cancer.   "
170564|NCT00070057|"     This randomized phase I trial is studying the side effects of celecoxib in treating     postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at     Memorial Sloan-Kettering Cancer Center. Celecoxib may stop the growth of tumor cells by     blocking the enzymes necessary for tumor cell growth.   "
170565|NCT00070070|"     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill     tumor cells. Biological therapies, such as BCG and sargramostim, use different ways to     stimulate the immune system and stop tumor cells from growing. Combining vaccine therapy with     biological therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects of giving vaccine therapy together     with BCG and sargramostim in treating patients who have undergone cystectomy for transitional     cell cancer of the bladder.   "
170555|NCT00069914|"     This study will evaluate how HIV infection, including CD4 cell count and viral load, affects     the patient's ability to produce antibodies in response to vaccination with the influenza     (flu) vaccine. Earlier studies have shown that people with HIV infection do not respond as     well as healthy subjects to flu vaccine; that is, they don't make as many antibodies in     response to the vaccine. Before the use of current anti-HIV medications, antibodies made to     flu vaccination in HIV-positive individuals was related to their CD4 cell count. This trial     will examine how CD4 counts and the amount of virus in the blood affect how much and what     kind of antibodies the body makes to the flu vaccine.      HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be     eligible for this study. Healthy subjects will serve as controls to make sure the flu vaccine     works (i.e., stimulates production of enough antibody to protect against the flu), and to     compare the amount of antibodies made by HIV-positive and HIV-negative people. Candidates     will be screened with a medical history and blood tests (see below). Women who are able to     have children will have a pregnancy test. Pregnant women are excluded from the study.      Participants will undergo the following procedures:        1. Blood drawing for the following tests:             -  Routine tests (complete blood count, kidney and liver functions, electrolyte               levels).             -  CD4 cell count.             -  HLA typing (a genetic marker of the immune system) if it has not already been done               at the NIH. This test may be used to try to identify factors associated with the               rate of progression of HIV disease or related conditions. Determining HLA type is               necessary to be able to perform certain research studies. Some HLA types have been               associated with an increased risk of certain diseases like arthritis and other               rheumatologic problems.             -  Viral load (HIV-infected patients only).             -  Influenza antibody levels.             -  B cell levels.        2. Flu vaccination        3. Follow-up visits on days, 7, 28, and 54 after vaccination for the following:             -  Review of any illnesses or fever.             -  Review of medications, if any changes were made.             -  Repeat blood tests.   "
170556|NCT00069927|"     RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help     improve memory, attention, and thinking problems caused by central nervous system (CNS)     treatment for cancer, and may help decrease depression.      PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how     well it works compared to methylphenidate in treating depression and problems with memory,     attention, and thinking in children who have undergone CNS treatment for cancer. This trial     will also study how often depression is seen and if these medications might help.   "
170557|NCT00069940|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Colony-stimulating factors such as sargramostim increase the number of immune cells found in     bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a     stronger immune response and kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given     together with sargramostim in treating patients with advanced sarcoma or brain tumor.   "
170558|NCT00069953|"     RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin use     different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation     therapy may kill more tumor cells      PURPOSE: This phase II trial is studying how well combination chemotherapy followed by     chemoradiotherapy, with or without surgery, works in treating patients with resectable     locally advanced cancer of the esophagus or gastroesophageal junction.   "
170559|NCT00069966|"     RATIONALE: Drugs used in chemotherapy, such as pixantrone, cytarabine, methylprednisolone,     and cisplatin, work in different ways to stop cancer cells from dividing so they stop growing     or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have relapsed aggressive non-Hodgkin's lymphoma.   "
170560|NCT00069992|"     Patients are being asked to participate in this study because they have a malignant blood     disease such as Myelodysplastic Syndrome (MDS), Myeloproliferative Disorder (MPD), Acute     Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia (CML). We feel that patients could     benefit from an allogeneic (meaning the cells come from a donor other than themself) stem     cell transplant. The donor would be a family member or an unrelated person that is felt to be     a good match for the patient. Stem cells are cells that are made in the bone marrow (spongy     material that fills the middle of the bones). As the stem cells grow, they change into     different types of blood cells that they need. This includes red blood cells that carry     oxygen around the body, white blood cells that help to fight infections, and platelets that     help to prevent and stop bleeding. Usually, patients are given high doses of chemotherapy     before a stem cell transplant. High doses of chemo destroy the bone marrow. Healthy stem     cells from a donor are then given to replace the patient's unhealthy cells. However, because     of complications with the patient's disease, they have a high risk of having life-threatening     side effects. These include serious damage to organs such as the lung, liver, kidney and     heart. There is also an increased risk of bacterial, fungal, and viral infections. The other     major problem is when a donor's stem cells (also called the graft) find that the patient's     cells ( the host cells) are not the same. The donor cells may try to destroy the host's     cells. The cells at high risk are those of the skin, liver and intestines. This is called     graft versus host disease (GVHD) and it can be fatal.      Recently, doctors have been able to use less toxic chemotherapy treatments before patients     receive their transplants. This less toxic treatment helps reduce some of the treatment     related problems mentioned above. Patient's are being asked to be involved in a research     study that uses this approach. One major risk of this low dose treatment is that the     patient's body may reject the donor cells. This is called graft rejection. This study is     designed to see if this low dose treatment is safe and effective.      This treatment plan adds CAMPATH 1H (a special protein called an antibody) to a low dose     chemotherapy regimen. After chemo, the patient will receive an allogeneic (cells come from a     donor) stem cell transplant. Adding CAMPATH 1H to the transplant medicines may help in     treating the disease. CAMPATH 1H may reduce life-threatening and treatment related side     effects like GVHD. CAMPATH 1H stays active in the body for a long time which means it may     work longer to prevent GVHD. CAMPATH 1H destroys lymphocytes, a type of white cells that help     fight infection, and this helps prevent graft rejection.      We want to see if the addition of CAMPATH 1H to the patient's pre-transplant low dose     chemotherapy will decrease the side effects from an allogeneic stem cell transplant, while     providing a curative treatment for patients with blood disorders.   "
170561|NCT00070005|"     RATIONALE: A coloanal anastomosis may be effective in restoring bowel function after     radiation therapy and surgery to remove the rectum. It is not yet known whether a J-pouch     coloanal anastomosis is more effective than a side-to-end coloanal anastomosis in restoring     bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy     and surgery to remove the rectum.      PURPOSE: This randomized phase III trial is studying how well J-pouch coloanal anastomosis     works compared to side-to-end coloanal anastomosis in treating patients with rectal     adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.   "
170562|NCT00070018|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine,     and prednisone, use different ways to stop cancer cells from dividing so they stop growing or     die. Radiation therapy uses high-energy x-rays to damage cancer cells. Monoclonal antibodies,     such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either     kill them or deliver radioactive cancer-killing substances to them without harming normal     cells. Combining chemotherapy with radiation therapy and monoclonal antibody therapy may kill     more cancer cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with radiation therapy and monoclonal antibody therapy works in treating patients with stage     I or stage II non-Hodgkin's lymphoma.   "
170563|NCT00070031|"     RATIONALE: Drugs used in chemotherapy such as edotecarin use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well edotecarin works in treating women with     locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.   "
170566|NCT00070083|"     RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, use     different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may     increase the effectiveness of a chemotherapy drug by making cancer cells more sensitive to     the drug. Combining oblimersen with rituximab and combination chemotherapy may kill more     cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of oblimersen when     given together with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in     treating patients with stage II, stage III, or stage IV large B-cell lymphoma   "
170600|NCT00070109|"     This phase II trial is studying how well trabectedin works in treating young patients with     recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in     chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they     stop growing or die.   "
170762|NCT00073385|"     This randomized study will assess the efficacy and safety of the combination of Pivanex and     docetaxel compared to docetaxel alone in patients with a type of lung cancer called non-small     cell lung cancer. Pivanex is an investigational agent, and docetaxel is an approved drug.   "
170567|NCT00063284|"     Super rapid transcranial magnetic stimulation (srTMS) is a method of brain stimulation that     may be able to change the electrical activity of the nerve cells of the brain. It has been     proposed and tested as a treatment for brain disorders, including Parkinson's disease.      The purpose of this study is to use a device called the magnetic stimulator to investigate     the safe limit of srTMS, such as intensity of stimulation and the number of magnetic pulses     that may lead to excessive brain stimulation.      Ten patients with Parkinson's disease-whose main problems are slowness of movement and     difficulty walking-will participate in this study. They will be asked to come to the     laboratory for one experiment. Before and after srTMS treatment, investigators will test     participants' brain function with a series of psychological tests and an EEG     (electroencephalogram). The srTMS treatment is performed by placing an insulated coil of wire     on the scalp and passing a very brief electrical current through the wire coil. The     experiment will last 2 to 4 hours.   "
170568|NCT00063297|"     This study is to determine the efficacy (how well the drug works), safety, and side effects     of the study medication compared to placebo in the treatment of the negative symptoms of     schizophrenia in adults.   "
170569|NCT00063310|"     ALADDIN is a research study to investigate the safety and effectiveness of leuprolide (a     hormone drug) to improve the cognitive function and slow the progression of Alzheimer's     disease (AD). In women leuprolide is commonly used to treat hormone related conditions such     as endometriosis and uterine fibroids. The study will include treatment of women 65 years and     older with mild to moderate Alzheimer's disease who reside in the community.   "
170570|NCT00063323|"     The purpose of this study is to determine the efficacy and cost-effectiveness of long-term     pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate     associated with stopping smoking.   "
170571|NCT00063336|"     This study will examine the ways in which schizophrenia-related symptoms affect response to a     rehabilitation program for people with schizophrenia.   "
170572|NCT00063362|"     This study will compare triple and double drug regimens in the treatment of patients with     depression, hypomania, or mania.   "
170573|NCT00063375|"     This study will develop an interactive computer-based version of cognitive behavioral therapy     (CBT) and compare its effectiveness to book-based CBT for the treatment of panic disorder.   "
170574|NCT00063388|"     Determine tumor response rate and time to disease progression, survival and safety in total     populations.   "
170575|NCT00063401|"     The purpose of this study is to determine the progression-free survival obtained with     cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage     ovarian, primary peritoneal, or fallopian tube cancer.   "
170576|NCT00063414|"     This is a multi-center trial to test the safety, efficacy and tolerability of alicaforsen     (ISIS 2302), a new type of drug called an antisense drug, in patients with mild to moderate     active Ulcerative Colitis (UC). Alicaforsen is designed to reduce the production of a     specific protein, called ICAM-1, a substance that plays a significant role in the increase of     inflammation and is likely to be involved in inflammatory bowel diseases such as ulcerative     colitis. The ISIS 2302-CS22 study will examine the effects of one of two dosages of     alicaforsen delivered by enema over a six-week period as compared to an active control,     mesalamine enema (The probability of receiving the alicaforsen formulation is 2:1). The     primary objective of this study is to evaluate the percentage reduction in DAI at Week 6.   "
170577|NCT00063427|"     Assess the clinical activity of MAC-321 administered IV as a second-line or third-line     antineoplastic agent to subjects with advanced colorectal cancer. Clinical activity will be     assessed by determining the percentage of subjects exhibiting an objective response (complete     plus partial responses). Tumor response will be assessed following modified Response     Evaluation Criteria in Solid Tumors (RECIST) guidelines.   "
170578|NCT00063440|"     To determine the factors associated with progression of sub-clinical atherosclerosis and to     evaluate the associations between the progression of sub-clinical atherosclerosis and the     development of clinically manifest atherosclerosis.   "
170579|NCT00063453|"     To test whether supplementation with selenium and/or vitamin E affects pulmonary function.   "
170580|NCT00063479|"     The primary purpose of this trial is to evaluate whether the investigational medication is     safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta     (OI) patients.   "
170581|NCT00063492|"     To determine the role of the angiotensinogen gene in human hypertension.   "
170582|NCT00063505|"     To identify genes contributing to hypertension in African Americans by focusing on the     physiological pathways that determine arterial pressure.   "
170583|NCT00063518|"     To describe time trends in the epidemiology of venous thromboembolism.   "
170584|NCT00063531|"     The purpose of this study is to compare two methods of diagnosing coronary artery disease     (CAD), thallium single photon emission computed tomography (SPECT) and ultrafast computed     tomography (CT).   "
170585|NCT00063544|"     To measure associations between physical activity and obesity in a large, population-based     cohort of children.   "
170586|NCT00063557|"     To investigate if neighborhood characteristics are related to disease risk in a multiethnic     cohort.   "
170587|NCT00063570|"     The purpose of the study is to determine if the two drugs can help patients feel better while     causing the tumor to become smaller or disappear; evaluate the safety of giving both     pemetrexed and gemcitabine in patients with advanced breast cancer.   "
170588|NCT00063583|"     The purpose of this study is to determine whether a new investigational drug, pirfenidone,     will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is     that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced     kidney disease will lead to preservation of kidney function.   "
170589|NCT00063596|"     Extremely low birth weight infants have decreased blood levels of Vitamin A. This Vitamin A     deficiency may increase the risk of infections and chronic lung disease in these infants.     This study will examine the effects of Vitamin A supplementation in premature babies born     weighing less than 1500 grams (3.3 lbs).   "
170624|NCT00070525|"     This phase II trial is studying how well tipifarnib works in treating young patients with     recurrent or progressive high-grade glioma, medulloblastoma, primitive neuroectodermal tumor,     or brain stem glioma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes     necessary for their growth.   "
170590|NCT00063609|"     The purpose of this study is to compare the effect of an investigational drug used     intravenously and placebo administered every three months for one year, on bone loss     associated with initial androgen deprivation) in men with prostate cancer without metastasis.     In order to participate in this trial male patients must be 18 years of age or older and have     been diagnosed with prostate cancer without metastasis and within one year of starting their     androgen deprivation therapy at the day of randomization onto this trial. In addition,     patients who have undergone a recent orchiectomy (orke-ek'te-me) (removal of one or two     testes) are eligible to participate.      Patients who received any prior bisphosphonate therapy or prior treatment with systemic     corticosteroids within in the past 12 months are not eligible to participate. Also patients     who are receiving treatment for osteoporosis are not eligible to participate.      Inclusion into this clinical trial with this investigational drug is based on the protocol     entry criteria and evaluation from a participating trial investigator.   "
170591|NCT00063622|"     The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead     to an improvement in liver histology in non-diabetic adult patients with non-alcoholic     steatohepatitis (NASH).   "
170592|NCT00063635|"     The purpose of this study is to determine if therapeutic modification of insulin resistance     or oxidative stress leads to improvement in serum or histologic indicators of liver injury or     quality of life.   "
170593|NCT00063648|"     Despite advances in medical and gene therapy, orthotopic liver transplantation remains the     only definitive therapeutic option for children with end-stage liver disease. Recent advances     in pre-, intra-, and early post-transplant care have resulted in a dramatic improvement in     survival of the pediatric liver transplant patient. The broad long-range goal of our research     program is directed at enhancing the patient's long-term survival. Our primary focus relates     to obligate life-long immunosuppression, with its inherent complications including severe     infection and development of cancer. These two complications come together in a single     disease, Epstein-Barr Virus (EBV)- associated post-transplant lymphoproliferative disorder     (PTLD). EBV, a latent human lymphotrophic herpes virus infects and immortalizes B cells.     Primary infection usually occurs via salivary exchange and results in a mild, self-limited     illness followed by life-long EBV-specific T cell controlled EBV latency. T cell-based     immunosuppression prevents allograft rejection, however, it also suppresses cytotoxic T     lymphocyte (CTL) function, generating an environment in which EBV-infected cells can     proliferate. Patients receiving life-long T cell-based immunosuppression have an increased     risk of developing PTLD due to their inability to produce normal immunoregulatory responses.     This disease is particularly devastating to the pediatric patient as its incidence is at     least 4-fold greater than in the adult liver transplant patient population. In fact, PTLD is     the number one cause of death following pediatric liver transplantation. At this time, there     is no definitive method of prospectively detecting, diagnosing, or treating PTLD, and current     treatment protocols place the liver allograft and patient at risk. Therefore, a diagnostic     tool that is both sensitive and specific, and a treatment strategy with low toxicity are     greatly needed to decrease the morbidity and mortality suffered by the pediatric liver     transplant patient with PTLD. Our proposed studies will support our hypothesis that the     combination of a persistently elevated EBV load in the setting of a diminished immune     response to EBV will be an early risk indicator associated with PTLD development, and that     pre-emptive treatment utilizing autologous adoptive EBV-specific CTL immunotherapy will     provide a low toxicity treatment option.   "
170594|NCT00063661|"     Parkinson's disease patients usually have difficulty making automatic movements. Automatic     movements are movements people often make without conscious thought.      The purpose of this study is to investigate regions of the brain that affect automatic     movements and to understand the movements of Parkinson's patients. Investigators hope this     knowledge will lead to better treatment for the disease.      Thirty participants will be enrolled in this study. Each will give a medical history and     undergo a brief physical exam. Participants will have two MRI scans, each lasting     approximately 1.5 hours. During these scans, they may be asked to move their right or left     hands or to remember some letters that they have been shown. Before undergoing the second     scan, participants will be asked to practice the tasks until they can perform them correctly.   "
170595|NCT00063674|"     Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls.      The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled     to tripled in the past two decades, with the highest rates among poor and ethnic minority     girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in     overweight children, and more children are manifesting precursors of heart disease and     stroke.      Our Two Approaches:        1. A state-of-the-art nutrition education program with monthly newsletters mailed to girls          and their parents and quarterly evening lectures/educational events at school sites,          including cooking demonstrations and games to improve nutrition and increase physical          activity.        2. After-school dance classes held five days per week all year long at school sites from          the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised          homework study hall each day, and emphasize both traditional ethnic dances and popular          dance.      Participants: Second, third and fourth grade girls and their families will be eligible to     participate. All activities are free of charge. To be able to perform a valid evaluation, to     be able to accommodate all girls at their own school, and to be fair about which girls     receive which program, families who wish to participate will be randomly selected to     participate in either one program or the other (nutrition education or dance classes). Each     family will participate for two years.      Evaluation: Trained Stanford staff will perform all evaluation procedures with participating     families in their own homes at the beginning and every six months. Families will be     compensated for their participation.   "
170596|NCT00063687|"     The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and     safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial     in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient     Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and     hospitalization) will be assessed as a composite endpoint in this trial.   "
171005|NCT00076492|"     The goal of this study is to assess the impact of CoQ10 and GPI 1485 on the progression of     Parkinson's disease, in order to determine whether it is reasonable to proceed with further     study of either of these agents.   "
170597|NCT00063700|"     This pilot study on the impact of a non-commercialism policy in Seattle schools will assess     and evaluate obesity-related health outcomes of a real-life policy decision, recently voted     on and adopted by the Seattle School Board. The policy reduces the exposure to advertising     and other marketing pressures, including those from commercial food vendors.   "
170598|NCT00063713|"     The purpose of this study is to find out whether treatment with VELCADE will increase the     time it takes for lymphoma to get worse.   "
182659|NCT00233571|"     The purpose of the study is to assess the long-term safety and clinical efficacy of     adalimumab in patients with rheumatoid arthritis   "
170601|NCT00070122|"     Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, and capecitabine,     work in different ways to stop cancer cells from dividing so they stop growing or die.     Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal     antibody therapy may kill more tumor cells. It is not yet known which combination     chemotherapy regimen with bevacizumab works better in treating colorectal cancer. This     randomized phase III trial is studying giving two different combination chemotherapy regimens     together with bevacizumab and comparing how well they work in treating patients with locally     advanced, metastatic, or recurrent colorectal cancer   "
170602|NCT00070135|"     This phase II trial studies how well fludarabine and busulfan followed by a donor     (allogeneic) stem cell transplant work in treating older patients with acute myeloid leukemia     that is in first complete remission. Giving low doses of chemotherapy, such as fludarabine     and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of     cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells.     It may also stops the patient's immune system from rejecting the donor's stem cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem     cells may replace the patient's immune system and help destroy any remaining cancer cells.     Sometimes the transplanted cells from a donor can make an immune response against the body's     normal cells (called graft-versus-host disease). Giving tacrolimus, methotrexate, and rabbit     antithymocyte globulin before or after the transplant may stop this from happening.   "
170603|NCT00070148|"     RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life     in patients with cancer. It is not yet known whether oxandrolone is more effective than     megestrol in preventing weight loss and improving quality of life in patients who are     receiving chemotherapy for solid tumors.      PURPOSE: This randomized phase III trial is studying oxandrolone to see how well it works     compared to megestrol in preventing weight loss and improving quality of life in patients who     are receiving chemotherapy for solid tumors.   "
170604|NCT00070161|"     RATIONALE: Donepezil and EGb761 may be effective in improving neurocognitive function (such     as thinking, attention, concentration, and memory) and may improve quality of life in     patients who have undergone radiation therapy to the brain.      PURPOSE: This phase II trial is studying how well donepezil or EGb761 works in improving     neurocognitive function in patients who have undergone radiation therapy for primary brain     tumor or brain metastases.   "
170605|NCT00070174|"     RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem     cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.     When the healthy stem cells from a donor are infused into the patient they may help the     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.      PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating     young patients who are undergoing remission induction, intensification therapy, and     allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.   "
170606|NCT00070187|"     RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing     so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation     may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.     Giving immunotherapy using cyclosporine, interferon gamma, and interleukin-2 after stem cell     transplantation may help the transplanted cells make an immune response and kill any     remaining cancer cells. It is not yet known whether high-dose chemotherapy followed by     autologous stem cell transplantation is more effective with or without immunotherapy.      PURPOSE: This randomized phase II/III trial is studying how well high-dose chemotherapy     followed by autologous stem cell transplantation, cyclosporine, interferon gamma, and     interleukin-2 works and compares it to high-dose chemotherapy followed by autologous stem     cell transplantation only in treating patients with refractory or relapsed Hodgkin's     lymphoma.   "
170607|NCT00070200|"     RATIONALE: Drugs used in chemotherapy, such as topotecan and cyclophosphamide, use different     ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy     with autologous stem cell transplantation may allow the doctor to give higher doses of     chemotherapy drugs and kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects of induction chemotherapy using     cyclophosphamide and topotecan in treating patients who are undergoing surgery and autologous     stem cell transplantation followed by radiation therapy for newly diagnosed or progressive     neuroblastoma.   "
170673|NCT00072111|"     RATIONALE: Biological therapies, such as anakinra, may interfere with the growth of the tumor     cells and slow the growth of metastatic tumors that express the interleukin-1 gene.      PURPOSE: This phase I trial is studying the side effects and best dose of anakinra in     treating patients with metastatic cancer that expresses the interleukin-1 gene.   "
170608|NCT00070213|"     RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and     oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than one drug may kill more tumor cells. It is not yet known whether     leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine     with or without oxaliplatin in treating patients who have metastatic colorectal cancer.      PURPOSE: This randomized phase III trial is studying four different chemotherapy regimens to     compare how well they work in treating patients with metastatic colorectal cancer.   "
170609|NCT00070239|"     This phase I trial is studying the side effects and best dose of alvocidib in treating     patients with metastatic or unresectable refractory solid tumors or hematologic malignancies.     Drugs used in chemotherapy, such as alvocidib, work in different ways to stop cancer cells     from dividing so they stop growing or die.   "
170660|NCT00071942|"     Vaccines may make the body build an immune response to kill tumor cells. This phase I trial     is studying the side effects and best dose of vaccine therapy in treating patients with     metastatic breast cancer.   "
170610|NCT00070252|"     Phase I/II trial to study the effectiveness of neoadjuvant tipifarnib combined with docetaxel     and capecitabine in treating patients who have locally advanced or metastatic solid tumors or     stage IIIA or stage IIIB breast cancer. Tipifarnib may stop the growth of tumor cells by     blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as     docetaxel and capecitabine, use different ways to stop tumor cells from dividing so they stop     growing or die. Combining tipifarnib with docetaxel and capecitabine may kill more tumor     cells.   "
170611|NCT00070265|"     Drugs used in chemotherapy, such as capecitabine and oxaliplatin, use different ways to stop     tumor cells from dividing so they stop growing or die. Giving capecitabine and oxaliplatin     before surgery may shrink the tumor so that it can be removed. Giving capecitabine and     oxaliplatin after surgery may kill any remaining tumor cells. This phase II trial is studying     how well capecitabine and oxaliplatin work when given before and after surgery in treating     patients with resectable liver metastases that is secondary to colorectal cancer   "
170612|NCT00070278|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, paclitaxel, and     gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die.     Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed     during surgery. It is not yet known which combination chemotherapy regimen is more effective     in treating early breast cancer.      PURPOSE: This randomized phase III trial is studying different regimens of combination     chemotherapy to compare how well they work in treating women who are undergoing surgery for     early invasive breast cancer.   "
170613|NCT00070291|"     RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic     T-cell lymphoma.      PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients     with recurrent or refractory angioimmunoblastic T-cell lymphoma.   "
170614|NCT00070304|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and vinorelbine, use different     ways to stop cancer cells from dividing so they stop growing or die. Combining more than one     drug may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with     vinorelbine works in treating young patients with recurrent or refractory Hodgkin's lymphoma.   "
170615|NCT00070317|"     This clinical trial is studying how well lymph node mapping and sentinel lymph node     identification work in finding lymph node metastases in patients with stage IB1 cervical     cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node     identification, performed before and during surgery, may improve the ability to detect lymph     node metastases in patients who have cervical cancer.   "
170616|NCT00070343|"     RATIONALE: Drugs used in chemotherapy, such as dacarbazine, use different ways to stop tumor     cells from dividing so they stop growing or die. Oblimersen may help dacarbazine kill more     tumor cells by making them more sensitive to the drug.      PURPOSE: This clinical trial is studying how well giving oblimersen together with dacarbazine     works in treating patients with advanced malignant melanoma that previously responded to     treatment with oblimersen and dacarbazine on clinical trial GENTA-GM301.   "
170617|NCT00070382|"     RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and     treat anemia in patients who are receiving chemotherapy. It is not yet known whether     darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia.      PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with     that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for     cancer.   "
170618|NCT00070421|"     RATIONALE: Using an Internet Web site that enables children with cancer to interact online     with classmates, participate in classroom activities, get easy-to-read medical information,     and chat with family members, medical staff, and other children with cancer may help children     cope with isolation, fear, and decreased self-esteem.      PURPOSE: This phase I/II trial is studying the effectiveness of an Internet Web site in     providing social support and education to children who are undergoing treatment for cancer.   "
170619|NCT00070434|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, fluorouracil, and     oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or     die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation     therapy with chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well different regimens of induction     chemotherapy followed by chemoradiotherapy work in treating patients with locally advanced     adenocarcinoma of the rectum.   "
170620|NCT00070447|"     RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan,     can locate cancer cells and either kill them or deliver radioactive cancer-killing substances     to them without harming normal cells. Drugs used in chemotherapy, such as prednisone,     cyclophosphamide, doxorubicin, and vincristine, use different ways to stop cancer cells from     dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy     may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab and combination     chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with     previously untreated mantle cell lymphoma.   "
170621|NCT00070473|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, use different ways to     stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the     growth of tumor cells by blocking the enzymes necessary for their growth.      PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed disodium     in treating young patients with recurrent solid tumors.   "
170622|NCT00070486|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different     ways to stop tumor cells from dividing so they stop growing or die. Celecoxib and zileuton     may stop the growth of tumor cells by stopping blood flow to the tumor and may block the     enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib and/or     zileuton may kill more tumor cells.      PURPOSE: Randomized phase II trial to study the effectiveness of combining celecoxib and/or     zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small     cell lung cancer.   "
170623|NCT00070499|"     This randomized phase IIB trial studies imatinib mesylate at two different doses and     dasatinib to see how well they work in treating patients with previously untreated chronic     phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth.   "
170625|NCT00071461|"     Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including     pulmonary vascular disease and pulmonary fibrosis.      Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic     pulmonary fibrosis (IPF), a condition for which no established treatment is available.      The present trial investigates a possible use of bosentan, which is currently approved for     the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a     new category of patients suffering from IPF.      It was decided to offer Open Label treatment (bosentan) for patients willing to continue in     the BUILD 1 study.   "
170626|NCT00071474|"     This is a Phase I study to examine the feasibility and safety of shamanic (spiritual) healing     for treating temporomandibular joint disorders (TMDs).   "
170627|NCT00071487|"     The purpose of this study is to evaluate the safety and efficacy of 3 different doses of     belimumab, administered in addition to standard therapy, in patients with active SLE disease.   "
170628|NCT00071500|"     Anti-HIV drug regimens can be very complicated. This study will evaluate a new electronic     pillbox designed to help people take their anti-HIV drugs correctly.   "
170629|NCT00071513|"     This study will implement a school-based program to prevent depression, academic failure, and     substance use in at-risk adolescents transitioning from middle school to high school.   "
170630|NCT00071526|"     Several studies have reported that diabetic subjects have lower plasma vitamin C     concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic     subjects was reported to be increased in two studies, these are difficult to interpret due to     lack of controlled vitamin C intake, inadequate sampling, lack of control subjects, or     methodology uncertainties in vitamin C assay and sample processing. Consequently, it is     unclear whether diabetic subjects truly have both low plasma and high urine vitamin C     concentrations. We propose that low plasma vitamin C concentrations in diabetic subjects are     due in part to inappropriate renal loss of vitamin C in these subjects but not in healthy     controls. We will study vitamin C concentrations in patients with type 1 and type 2 diabetes     and in matched healthy research subjects. Vitamin C concentrations in plasma, neutrophils (as     a proxy for tissue concentrations) and in urine will be measured in outpatients. In those     willing to be admitted to the Clinical Center, we will measure 24-hour urinary excretion of     vitamin C while on a vitamin C free diet, and creatinine clearance, a measure of glomerular     filtration rate. On day 2 of the inpatient study, subjects will receive a single 200mg dose     of oral vitamin C and we will measure vitamin C concentrations in frequent blood and urine     samples to determine the renal threshold and relative bioavailability for vitamin C. Single     nucleotide polymorphisms (SNPs) will be determined in genomic DNA responsible for the two     proteins mediating sodium-dependent vitamin C transport, SVCT1 and SVCT2. If low plasma and     high urine vitamin C concentrations are found in diabetic subjects, further studies will be     needed to explore mechanisms and to determine recommended dietary allowances for this patient     population.   "
170631|NCT00071539|"     Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin     therapy may be effective in treating malignant glioma.   "
170632|NCT00071552|"     The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate     HFA on small airways compared to Fluticasone propionate powder for inhalation administered     twice daily to poorly controlled asthmatics.   "
170633|NCT00071565|"     The purposes of this study are to identify possible genes that may increase the risk of     aneurysm development in the brain, and to determine the effect of environmental factors such     as cigarette smoking and high blood pressure on the expression of these genes.   "
170634|NCT00071578|"     This study will compare two different approaches for the treatment for Binge Eating Disorder.   "
170635|NCT00071591|"     This study will evaluate the effectiveness of a rehabilitation program called Functional     Adaptation Skills Training (FAST) in treating older patients with schizophrenia.   "
170636|NCT00071604|"     This study will determine whether Medication Adherence Therapy (MAT) can improve medication     adherence and lower the risk of rehospitalization in older patients with psychosis.   "
170637|NCT00071617|"     This study will attempt to improve treatment adherence and reduce suicide risk among     adolescents who are at risk for attempting suicide.   "
170638|NCT00071630|"     The purpose of this study is to examine the relationship between different aspects of     cognitive behavior therapy (CBT) and treatment outcome.   "
170639|NCT00071643|"     This study will evaluate the effectiveness of both drug and non-drug treatments in preventing     depression after a stroke.   "
170640|NCT00071656|"     The purpose of this study is to develop and implement a treatment that focuses on behaviors     to reduce symptom severity and functional impairment in patients with Attention Deficit     Hyperactivity Disorder, Predominantly Inattentive Type (ADHD-I). The long-term goal of this     study is to apply the treatment to larger-scale trials to determine its effectiveness and     generalizability.   "
170641|NCT00071669|"     The purpose of this study is to evaluate the effectiveness of acupuncture in the treatment of     Bipolar Depression.   "
170642|NCT00071682|"     The purpose of this study is to determine if the use of herbal products interferes with     normal anticoagulation, leading to either excessive thinning of the blood and bleeding     problems or inadequate thinning of the blood and clotting problems. Many patients who are on     long term anticoagulation, or blood thinning, for a variety of medical problems, also take     herbal products. It is not yet known whether use of herbal products interferes with this     anticoagulation, and puts patients at risk for bleeding or clotting. This study will     carefully monitor patients who are taking herbs and anticoagulants to determine if their     laboratory tests show signs of being affected by the herbs. The study will ask all patients     about their herbal product use, so all reported herbs will be included and monitored.   "
170643|NCT00071695|"     How duloxetine compares to a medication currently available for the treatment of patients     diagnosed with depression   "
170644|NCT00071708|"     The primary objective of this study is to provide duloxetine to investigators for the     treatment of patients who have previously participated in neuroscience duloxetine clinical     trials and for whom effective alternative therapy is not available.   "
182698|NCT00234091|"     The purpose of this study is to determine when HIV infected children should begin taking     anti-HIV medications in order to improve both patient quality of life and survival.   "
170645|NCT00071721|"     The purpose of this trial is to demonstrate whether valproate therapy delays the emergence of     agitation and/or psychosis in outpatients with probable Alzheimer's disease (AD) who have not     experienced agitation and psychosis in their illness. A secondary aim is to determine whether     valproate therapy delays the progression of cognitive and functional measures of the illness.     This trial will also assess the tolerability and safety of low-dose, long-term valproate     therapy. Valproate, an anticonvulsant drug, was selected because of its possible symptomatic     efficacy for agitation in AD, known safety profile in numerous clinical populations, and in     view of recent data supporting its neuroprotective potential in AD.   "
170646|NCT00071734|"     This study will examine the central regions and brain activation patterns associated with     simple vocal behaviors under conditions of normal auditory feedback-when people hear     themselves speak. Such feedback plays a major role in learning and maintaining human voice     control. But voice control can be harmed by neurological injury or disease, reducing the     ability of a person to orally communicate. Research has shown that auditory feedback is     continuously monitored, brought about by both automatic and voluntary corrections in the     amplitude (loudness) and frequency of (pitch) of the human voice. This study aims to     determine which areas of the brain have activity dependent on the level of blood oxygen. It     will provide new knowledge about basic vocal motor control and provide a basis for     investigations into the integration of hearing and speaking in human vocal expression     throughout life.      Participants 18 to 45 years of age with normal hearing and voice function and with a steady     heart rate may be eligible for this study.      Participants will be evaluated by a speech-language specialist, regarding a history of voice     health and measures of voice function. They will be tested on their ability to vary voice     amplitude and frequency and tested on their hearing. Also, they will undergo an     electrocardiogram to determine their heart rate.      For the study, participants will undergo an MRI scan. During the MRI scan, patients will lie     still on a table that can slide in and out of a metal cylinder surrounded by a strong     magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans between 45     and 90 minutes. Patients may be asked to lie still for up to 90 minutes at a time. As the     scanner takes pictures, there will be loud knocking noises, and patients will wear headphones     to muffle the sound. The headphones will also enable patients to hear their voice. The     patient's head will be positioned with a coil of 25 to 30 cm diameter and supported by a     headrest. A microphone will be placed about 2 cm from the patient's mouth for communication     and collection of data. Also, an angled mirror will be attached to the head coil, so that the     patient can look outside of the scanner. By way of a projection screen, the patient will     receive a visual cue to vocalize, or use his or her voice.      Patients will be asked to repeatedly do some of the following vocalization tasks: (1) rest,     (2) hum or sigh without voicing (exhale), (3) hum or sigh audibly, (4) hum audibly while     increasing or decreasing voice frequency, and (5) hum audibly while increasing or decreasing     voice amplitude. During the scan, patients will be able to communicate with the MRI staff at     all times and may ask to be moved out of the machine at any time. Some scans may be done in a     3 Tesla scanner. It is the latest advance in MRI, with a stronger magnetic field than in the     more common 1.5 Tesla scanner. Functional MRI is done while a person is performing tasks,     such as moving a limb or speaking. The fMRI scan will take about 1 hour.   "
170647|NCT00071747|"     The objective of this study is to evaluate the effectiveness of a marketed drug in the     treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period.     Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and     who fulfill the screening entrance criteria will have an assessment 1-7 days after the first     visit to confirm eligibility.   "
170648|NCT00071760|"     This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral     activity of an investigational regimen including FDA approved HIV drugs in HIV-infected     pediatric subjects, ages 4 weeks to < 2 years old.   "
170649|NCT00071773|"     This pilot study will compare the use of current laser treatment for diabetic macular edema     with a similar laser treatment that is milder in intensity, but more extensive.   "
170650|NCT00071786|"     This study will examine how depression, anxiety, and migraine run in families. It will help     in defining the risk factors for physical, mental, and health problems-as well as define ways     that those problems may be prevented and treated.      A broad range of ages among family members will be included to evaluate the patterns of how     these disorders are expressed throughout people's lives. Children of all ages will be     included, and those ages 8 to 17 will be interviewed directly.      Assessments will be collected through criteria of the Diagnostic and Statistical Manual of     Mental Disorders IV as well as the spectrum, or range, of mood disorders and co-existing     conditions. A member of the study team will visit the participants at home or will do an     interview by telephone. Participation will take approximately 3 to 4 hours. Children will     complete questionnaires given by the research team as well as questionnaires that they will     do by themselves. The questions will pertain to the children's health, including physical and     mental health and medical history, social relationships, problems, skills, and ways of     dealing with important or stressful issues in their lives. These questionnaires will take up     to 1 hour to complete.      Health history gathered from adult participants will pertain to height, weight, exercise, and     general function. Women will be asked about the use of oral contraceptives, estrogen, and     progesterone. In addition, there will be questionnaires on personality and temperamental     traits, that is, behavior and impulsiveness. Questions will also involve social intuition,     family and other environmental factors, general functioning, and basic demographics such as     ethnicity, race, socioeconomic status, marital status, education level, and employment     history.      Families enrolled in this phase of the research will be invited to participate in the next     phase. There would be follow-up to evaluate the development of mood disorders, subtypes, and     syndromes across the lifespan.   "
170651|NCT00071799|"     The purpose of this study is to determine whether patients with high-risk myelodysplastic     syndromes (MDS) treated with azacitidine have improved survival compared to conventional care     treatments. The study will also assess the effect of treatments on response, duration of     response, and transformation to acute myeloid leukemia (AML). The study will continue for 12     months following last patient enrolled.      See study AZA PH GL 2003 CL 001 E for information about the extension to this study.   "
170652|NCT00071812|"     The purpose of this study is to evaluate the safety and efficacy of 3 different doses of     belimumab, administered in addition to standard therapy, in patients with rheumatoid     arthritis (RA).   "
170653|NCT00071838|"     This study will examine the safety of Zenapax (daclizumab) in patients with multiple     sclerosis (MS). MS is thought to be caused by an over-reactive immune response. T-lymphocytes     (cells of the immune system), are thought to damage myelin, a substance that covers the nerve     and parts of the spinal cord and is damaged in patients with MS. Interleukin-2 is a natural     substance in the body that is necessary for the growth of T-lymphocytes. Zenapax is a     genetically engineered antibody that blocks the activity of interleukin-2 and thus interferes     with the growth of lymphocytes. Therefore, Zenapax may prevent some of the damage to myelin     that occurs in multiple sclerosis.      Patients between 18 and 65 years of age with relapsing remitting MS may be eligible for this     study. Patients with secondary-progressive or primary progressive MS may not participate.     Candidates will be screened with a complete neurological and medical evaluation and review of     medical records.      Participants will undergo the following tests and procedures:        -  Baseline evaluation: Participants have four magnetic resonance imaging (MRI) scans over          a 3-month period to assess disease activity. For the MRI scans, the patient lies on a          table that slides into the scanner - a narrow metal cylinder with a strong magnetic          field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between          45 and 90 minutes. Only patients with activity at or above a certain level are eligible          to continue with the treatment phase of the study.        -  Zenapax treatment: Patients receive intravenous (through a vein) infusions of Zenapax.          The first two infusions are 2 weeks apart, followed by 13 monthly infusions.        -  MRI scans: Patients undergo MRI scanning before every infusion to evaluate disease          activity and identify new brain lesions.        -  Blood and urine tests: Blood and urine samples are collected at each clinic visit for          routine laboratory evaluations, immunologic study, and genetic testing to determine a          predisposition for responding to Zenapax treatment.        -  Lumbar puncture (spinal tap): This procedure will be done during the last month before          starting treatment and during the seventh month of treatment to examine immune changes          that occur in the cerebrospinal fluid (CSF), which circulates through and surrounds the          brain and spinal cord. A local anesthetic is given and a needle is inserted in the space          between the bones in the lower back where the CSF circulates below the spinal cord. A          small amount of fluid is collected through the needle.        -  Skin test: A needle is placed just under the skin is done to assess the patient's immune          status to common antigens such as tetanus, mumps and candida.        -  Lymphocytopheresis: Lymphocytes are collected three times - once during the last month          of baseline before starting treatment, once during the fifth month of treatment, and          once during the last month of treatment - for immunologic study. Blood is collected          through a needle in an arm vein in a similar way to donating blood. The blood flows from          the vein through a catheter (plastic tube) into a machine that separates it into its          components by centrifugation (spinning). The lymphocytes are removed and the rest of the          blood (red cells, plasma and platelets) is returned to the body, either through the same          needle or through another needle in the other arm.   "
170654|NCT00071851|"     The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine,     VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will     be tested.   "
170655|NCT00071877|"     This study will evaluate the safety of multiple biweekly intravenous doses of Replagal over     26 weeks in 25 children with Fabry disease and the way in which that agent can improve the     health of this patient population. Fabry disease is a genetic disorder inherited as an     X-linked recessive trait. It causes a deficiency in the enzyme alpha galactosidase, which     normally breaks down a lipid, or fatty substance, called ceramidetrihexosidase, a building     block in all cells of the body.      The deficiency in breaking down the lipid eventually causes that lipid to accumulate and     injure cells. Problems in the blood vessels, kidneys, heart, and nerves are the result. The     disease typically occurs in childhood or adolescence, with repeated episodes of severe pain     in the extremities and other symptoms. There is no definitive treatment, but pain management     is important in caring for patients with Fabry disease. Although it is not known exactly how     lipid accumulation brings about such problems, studies of another lipid storage disorder,     Gaucher's disease, have shown that the illness can be reversed if the lipid is removed when     an appropriate enzyme, Replagal, is given intravenously. In this study, the gene response of     the body's cells to Fabry disease will be described, as will any gene responses that change     when the enzyme is used.      Patients 7 to 17 years of age who have Fabry disease may be eligible for this study. They     will undergo the following tests and procedures:        -  Physical examination.        -  Neurological examination.        -  Vital signs.        -  Urinalysis.        -  Blood tests to determine complete blood count and chemistries.        -  Questionnaire on pain.        -  Tests pertaining to sweating.        -  Electrocardiogram.        -  Doppler blood flow study.        -  Diary for recording symptoms and the use of pain medications.      Participants will go through the evaluation, over a period of about 5 days, either as an     inpatient or outpatient. Participants will receive an intravenous infusion of Replagal every     other week, at the dose of 0.2 mg/kg of body weight. Vital signs will be measured before the     infusion and immediately and after and 1 hour afterward. There will be careful monitoring for     allergic reactions and side effects. The infusion time takes approximately 40 minutes.      This study will last 6 months, with the possibility of being extended another 6 months-a     maintenance study in which patients will continue to receive Replagal at the same dose every     2 weeks.   "
170656|NCT00071890|"     This study will examine whether interleukin-2 (IL-2) given before the interruption of     antiretroviral (ARV) treatment could significantly extend the period of time that a patient     is temporarily not taking ARV treatment and also preserve CD4 counts above 350 cells per     microliter. There will be an evaluation of the toxicity, or extremely harmful effects, of     ARV, and the effect on quality of life.      The use of ARV medications has greatly improved the condition and mortality of HIV-infected     patients. But when used long term, those medications have been associated with great     toxicities and medication fatigue. As a result, patients may not adhere to ARV use, and     resistance to viruses may grow. The CD4 molecule is on the surface of helper T-lymphocytes,     or T-helper cells. It serves as the primary receptor for HIV-1 and HIV-2, allowing the virus     to gain entry into its host. The CD4 count increases immediately in response to ARV, giving     an estimate of the state of a patient's immune system. Thus, it is a strong marker of the     immediate risk of an opportunistic infection, one that takes advantage of a person's weakened     immune system. IL-2 is a molecule naturally produced by activated T cells. In patients with     HIV, IL-2 treatment can increase CD4 counts but the clinical importance of this increase is     not clear. This study will compare the decline in CD4 count, when ARV is interrupted, in two     random groups of participants: (1) those who will receive three cycles of IL-2 (one every 8     weeks) in combination with ARV therapy for the first 24 weeks of the study before stopping     ARV and (2) those who will receive ARV therapy without IL-2 for 24 weeks before stopping ARV.      Patients 18 years of age or older who have HIV-1 infection and who have been on ARV therapy     for at least 1 year, and who currently have a CD4 count 500 cells per microliter or higher     and never had a CD4 count of less than 200 cells per microliter and a viral load less than     the limit of detection, may be eligible for this study.      Participants will undergo the following procedures and tests:        -  Physical examination.        -  Blood tests to measure blood lipids (fats), sugar, complete blood count including          platelets, and chemistries.        -  Assessment of fat distribution.        -  Questionnaire about quality of life.      In addition, those participants who are randomly placed in the group receiving IL-2 and ARV     will get an echocardiogram at the beginning of the study and at week 24. They will receive a     starting dose of 6 million units of IL-2 as an injection under the skin twice a day. Each of     the three IL-2 cycles will last 5 days. After the 24-week period, participants in both groups     will stop taking ARV medications if their CD4 count is still equal to or greater than 500     cells per microliter. The study will continue into 120 weeks. Participants will be asked to     continue to visit the clinic every 8 weeks for evaluation of their viral load and CD4 counts.     Every 24 weeks, they will be asked to answer a questionnaire about their quality of life.     Blood tests and other measurements will also be done as follow-up.   "
170657|NCT00071903|"     This study will examine whether the tendency to have thrombosis, or the formation of blood     clots inside blood vessels, has a role in the development of pseudotumor cerebri (PTC). PTC     causes symptoms and signs of isolated elevated blood pressure in the cranium, or covering of     the brain. The disorder can lead to significant, negative effects on the visual system.     Increased pressure of the cerebrospinal fluid, that is, fluid around the brain, is a factor,     but the cause of the disorder is not clear. There has been documentation of clustering of PTC     within families. It suggests that potential genetic polymorphisms-abilities to take on     different forms-may become evident after exposure to conditions known to trigger PTC.      Thrombosis comes about by interactions between genetic and environmental or acquired factors,     or both, resulting in a blood clot at a specific time and location. Because the disease     occurs in episodes, the interaction of the genetic and nongenetic risk factors is important.     Cystinosis is a recessive disorder caused by deposits of cystine within the lysosomes of     cells-that is, sac-like cell parts that contain various enzymes. Involvement of the kidneys     remains the primary characteristic, eventually leading to renal failure. Of all of the risk     factors that make it easier for blood clotting, a high level of a substance called     homocysteine is of particular interest. Too much homocysteine in blood plasma is a common     finding in patients with kidney failure, and it has been recently identified as an     independent risk factor for diseases of the blood vessels.      Participants of all ages who meet the Dandy criteria for PTC may be eligible for this study.     Pregnant women will be excluded. There will also be a control group of nephropathic     cystinosis patients who do not have PTC.      Participants will be asked to undergo the following tests and procedures:        -  Medical history.        -  Physical examination, to evaluate the eye and nervous systems.        -  Collection of blood for DNA and other tests.        -  Collection of cerebrospinal fluid, through a procedure called lumbar puncture or spinal          tap.      The evaluation of patients will generally last 3 to 4 days. For the collection of     cerebrospinal fluid, the patient's skin on the back will be numbed with a local anesthetic. A     special needle will be inserted into the back, and a small amount of the fluid will be drawn     through the needle. There will be pain for a minute, although there can be a headache lasting     24 hours. Also, there may be bruising, local pain, bleeding, or infection where the needle     enters. Patients may also have a magnetic resonance imaging scan of their head. During the     MRI scan, patients will lie still on a table that slides in and out of a metal cylinder     surrounded by a strong magnetic field. Patients will be able to communicate with the MRI     staff at all times and may ask to be moved out of the machine at any time.   "
170658|NCT00071916|"     The purpose of this study is to evaluate a group of African Americans and Caucasians with     hepatitis C virus (HCV), compare their response rates to combination treatment with pegylated     interferon alfa-2b and ribavirin, and identify possible causes for racial differences in     response to therapy. The study will enroll a total of 260 participants, age 18 or older, over     a 10 period. In the next 5 years 132 subjects will be studied locally, including 112 African     Americans and 20 Caucasians. Participants will be recruited from the clinical practices of     the hepatologists (liver doctors) at the University of Tennessee Health Science Center and     will also be selected from referrals at local hepatology clinics and the Memphis VA Hospital.     Volunteers will be treated with pegylated interferon alfa-2b injections once weekly and oral     ribavirin 2 times a day for up to 72 weeks. Study procedures include multiple blood draws.     Participants may be involved in study related procedures for up to 72 weeks.   "
170659|NCT00071929|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who     have persistent or recurrent endometrial cancer.   "
170661|NCT00071955|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Vaccines made     from a person's cancer cells may make the body build an immune response to kill cancer cells.     Colony-stimulating factors such as sargramostim may increase the number of immune cells found     in bone marrow or peripheral blood.      PURPOSE: Phase II trial to study the effectiveness of rituximab followed by vaccine therapy     and sargramostim in treating patients who have refractory or progressive non-Hodgkin's     lymphoma.   "
170662|NCT00071968|"     RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor     cells from dividing so they stop growing or die. Giving CCI-779 before surgery may shrink the     tumor so that it can be removed.      PURPOSE: This randomized phase II trial is studying how well CCI-779 works in treating     patients who are undergoing radical prostatectomy for newly diagnosed prostate cancer at high     risk of relapse.   "
170663|NCT00071981|"     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill     tumor cells.      PURPOSE: This randomized phase II trial is studying four different vaccines using melanoma     peptides from cytotoxic T cells and helper T cells to see how well they work in treating     patients with metastatic melanoma.   "
170664|NCT00071994|"     Phase II trial to study the effectiveness of gefitinib in treating patients who have advanced     unresectable hepatocellular carcinoma (liver cancer). Gefitinib may stop the growth of tumor     cells by blocking the enzymes necessary for their growth   "
170665|NCT00072007|"     RATIONALE: Drugs used in chemotherapy, such as cladribine, use different ways to stop cancer     cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab,     can locate cancer cells and either kill them or deliver cancer-killing substances to them     without harming normal cells. Combining cladribine with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving cladribine and rituximab as     remission induction therapy together with rituximab and stem cell mobilization in treating     patients with chronic lymphocytic leukemia.   "
170666|NCT00072020|"     RATIONALE: Zoledronate may delay or prevent the formation of bone metastases. It is not yet     known whether chemotherapy and/or hormone therapy are more effective with or without     zoledronate in preventing cancer recurrence and bone metastases in women with breast cancer.      PURPOSE: This randomized phase III trial is studying giving chemotherapy and/or hormone     therapy together with zoledronate to see how well they work compared to chemotherapy and/or     hormone therapy alone in preventing cancer recurrence and bone metastases in women with stage     II or stage III breast cancer.   "
170667|NCT00072033|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation     therapy before surgery may shrink the tumor so that it can be removed.      PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together     with chemoradiotherapy followed by surgery works in treating patients with locally advanced,     resectable esophageal cancer.   "
170668|NCT00072046|"     RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of     tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the     tumor. It is not yet known whether interferon alfa-2b is more effective with or without     bevacizumab in treating advanced renal cell carcinoma (kidney cancer).      PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to     see how well they work compared to interferon alfa-2b alone in treating patients with     advanced renal cell carcinoma.   "
170669|NCT00072059|"     RATIONALE: Ro 50-3821 may stimulate red blood cell production and treat anemia in patients     who are receiving antineoplastic therapy for non-small cell lung cancer.      PURPOSE: This randomized phase II trial is studying six different regimens of Ro 50-3821 to     compare how well they work in treating anemia in patients who are receiving antineoplastic     therapy for stage IIIB or stage IV non-small cell lung cancer.   "
170670|NCT00072072|"     RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor.     Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary     for their growth. Combining celecoxib with erlotinib may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when     given together with erlotinib in treating patients with stage IIIB or stage IV non-small cell     lung cancer.   "
170671|NCT00072085|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: This randomized phase II trial is studying immunization using two different gp100     protein vaccines to compare how well they work in treating patients with metastatic melanoma.   "
170672|NCT00072098|"     RATIONALE: Inserting the interleukin-12 gene into a person's cancer cells may make the body     build an immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-12 gene     when injected into the tumors of patients with liver metastases secondary to colorectal     cancer.   "
170674|NCT00072124|"     RATIONALE: Drugs used in chemotherapy, such as dacarbazine and cisplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Complete metastasectomy     may be an effective treatment for metastatic melanoma and may improve quality of life and     help patients live longer and more comfortably. It is not yet known whether complete     metastasectomy is more effective than chemotherapy in treating stage IV melanoma.      PURPOSE: This randomized phase III trial is studying dacarbazine and/or cisplatin to see how     well they work compared to complete metastasectomy in treating patients with stage IV     melanoma.   "
170675|NCT00072137|"     This phase I trial studies the side effects and best dose of vaccine therapy given directly     into the bladder in treating patients who are undergoing surgery to remove all or part of the     bladder. Vaccines made from a gene-modified virus may help the body build an effective immune     response to kill tumor cells. Giving a vaccine directly into the bladder before surgery may     cause a stronger immune response and keep tumor cells from coming back after surgery.   "
170676|NCT00072150|"     Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor     cell growth. This phase II trial is studying how well bortezomib works in treating patients     with advanced transitional cell carcinoma of the urothelium.   "
170677|NCT00072163|"     This phase II trial is studying how well giving temozolomide together with thalidomide works     in treating patients with brain metastases secondary to melanoma. Drugs used in chemotherapy,     such as temozolomide, work in different ways to stop tumor cells from dividing so they stop     growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the     tumor. Combining temozolomide with thalidomide may kill more tumor cells   "
170678|NCT00072176|"     This phase II trial studies how well temsirolimus works in treating patients with endometrial     cancer that has spread to other parts of the body or has spread from where it started to     nearby tissue or lymph nodes and has come back after a period of time during which the cancer     could not be detected. Temsirolimus may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth.   "
170679|NCT00072189|"     UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.     This phase II trial is studying how well UCN-01 works in treating patients with metastatic     melanoma.   "
170680|NCT00072215|"     RATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and     vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether ifosfamide and cisplatin are more effective when combined     with paclitaxel or vinblastine in treating germ cell tumors.      PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to     see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men     with progressive or recurrent metastatic germ cell tumors.   "
170681|NCT00072228|"     RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, use different ways     to stop tumor cells from dividing so they stop growing or die. Combining more than one drug     may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of soblidotin and     gemcitabine in treating patients with locally advanced or metastatic solid tumors.   "
170682|NCT00072267|"     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop     tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor     cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may     kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in     treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial,     primary peritoneal, or fallopian tube cancer.   "
170683|NCT00072280|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Giving combination chemotherapy before surgery may     shrink the tumor so that it can be removed. Giving combination chemotherapy after surgery may     kill any remaining tumor cells.      PURPOSE: This phase II trial is studying how well surgery and/or combination chemotherapy     work in treating children with fibrosarcoma.   "
170684|NCT00072293|"     RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node     micrometastases may remove cancer cells that have spread from tumors in the breast. It is not     yet known whether surgery to remove the primary tumor is more effective with or without     axillary lymph node dissection.      PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node     dissection to see how well they work compared to surgery alone in treating women with     node-negative breast cancer and sentinel lymph node micrometastases.   "
170685|NCT00072319|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and paclitaxel,     use different ways to stop tumor cells from dividing so they stop growing or die. Giving     chemotherapy drugs before surgery may shrink the tumor so that it can be removed during     surgery. Giving chemotherapy drugs after surgery may kill any remaining tumor cells.      PURPOSE: Pilot trial to study the effectiveness of neoadjuvant or adjuvant epirubicin,     cyclophosphamide, and paclitaxel in treating women who have stage I, stage II, or stage III     breast cancer.   "
170686|NCT00072332|"     RATIONALE: Drugs used in chemotherapy, such as edotecarin and cisplatin, use different ways     to stop tumor cells from dividing so they stop growing or die. Combining edotecarin with     cisplatin may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining edotecarin with cisplatin in     treating patients who have advanced or metastatic solid tumors.   "
170687|NCT00072345|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide and lomustine, use different ways     to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the     growth of cancer by stopping blood flow to the tumor. Combining temozolomide and thalidomide     with lomustine may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide     with lomustine in treating patients who have unresectable stage III or stage IV melanoma.   "
170702|NCT00072579|"     RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of     immune cells found in bone marrow or peripheral blood and may bring about complete remission     in patients who have chronic phase chronic myelogenous leukemia.      PURPOSE: This phase II trial is studying sargramostim to see how well it works in treating     patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic     remission after initial treatment.   "
170703|NCT00072592|"     This study will examine the use of rituximab in patients with Wegener's granulomatosis (WG)     who have experienced a relapse of the disease through standard therapies. Rituximab is an     antibody directed against the human protein called CD20, found on the surface of normal and     abnormal B lymphocytes. Rituximab decreases the number of B lymphocytes. This study will     examine the safety of rituximab in WG and rituximab's ability to reduce the level of     circulating antineutrophil cytoplasmic antibodies (ANCA), which are antibodies that react to     substances found in white blood cells. ANCA have been found to be strongly associated with     WG. The study will also explore whether rituximab can reduce the occurrence of disease     relapse. WG is a disease marked by inflammation of blood vessels. It can involve many     different parts of the body, including the sinuses, lungs, kidneys, brain, nerves, eyes,     intestinal tract, skin, joint, heart, and others. Before the use of cytotoxic drug therapy,     WG was almost always fatal if untreated, with a mortality rate of 93% within 2 years.      Patients 18 to 75 years of age who have a history of at least one relapse of the disease     despite standard treatments, who have had active WG within the previous 12 months and are in     remission, who are receiving either methotrexate or azathioprine for remission maintenance,     and who have circulating ANCA, may be eligible for this study.      A minimum of 22 visits to the clinic will be required to complete the entire study. Patients     will undergo a comprehensive medical evaluation, with laboratory studies and x-rays. There     may also be consultations and possible biopsies of affected organs only if medically     indicated for diagnosis and treatment of the disease. In the 4-week period that patients will     receive rituximab infusions, the methotrexate or azathioprine will be continued at the same     dosage unless there are side effects that requite the medication to be temporarily stopped or     the dosage reduced. Patients will receive four doses of rituximab, at 375 mg per meter     squared of body surface area, once a week. It will be infused into a vein, through an     intravenous catheter. For the first dose, patients will be admitted as inpatients for at     least 24 hours, for monitoring during the infusion and for any reactions associated with it.     The second, third, and fourth rituximab infusions may be given either on an inpatient or     outpatient basis to be decided on how the patient tolerates the first infusion.      Following the four infusions, there will be blood tests to monitor the safety of the     medication and the status of the disease, to be done at home every week for 4 weeks. Results     will be sent to the researchers by fax. Patients will be asked to return to the clinic 1     month after the fourth infusion and every 1 to 3 months afterward. If there are no side     effects or a relapse of the disease, the methotrexate or azathioprine will be continued for 2     years past remission. If by then the disease then remains in remission, the dose of either     medication will be gradually decreased and eventually stopped. The usual schedule is to     reduce methotrexate by 2.5 mg per month and to reduce azathioprine by 25 mg per month. If at     that point there are no signs of active disease, the patients' illness will be considered to     be in continued remission and no further treatment will be necessary. If relapse does occur,     treatment would be different than previously. In most cases, treatment would involve     prednisone and cyclophosphamide or methotrexate If the ANCA finding is negative after     rituximab treatment and again becomes positive, and there is evidence of a return of B     lymphocytes, patients may receive a second course of four rituximab infusions.   "
170688|NCT00072358|"     RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and     either kill them or deliver tumor-killing substances to them without harming normal cells.     Colony-stimulating factors, such as sargramostim, may increase the number of immune cells     found in bone marrow or peripheral blood. Combining monoclonal antibody 3F8 with sargramostim     may cause a stronger immune response and kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with     sargramostim in treating patients who have neuroblastoma.   "
170689|NCT00072384|"     Phase III trial to determine the effectiveness of combining systemic chemotherapy and     subtenon carboplatin with ophthalmic therapy in treating children who have intraocular     retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide,     work in different ways to stop tumor cells from dividing so they stop growing or die. It is     not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye)     carboplatin combined with ophthalmic therapy is effective in treating intraocular (within the     eyeball) retinoblastoma.   "
182745|NCT00234728|"     The purpose of this study is to determine if a new dressing designed to be used with topical     medications will enhance the effects of these topical medications.   "
170690|NCT00072410|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive     tumor-killing substances to them without harming normal cells. Giving radiolabeled monoclonal     antibody directly into the abdominal cavity may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of giving radiolabeled monoclonal antibody     therapy directly into the abdominal cavity in treating patients who have advanced ovarian     epithelial cancer.   "
170691|NCT00072436|"     This phase I trial is studying the side effects and best dose of gemcitabine hydrochloride     and alvocidib in treating patients with solid tumors. Drugs used in chemotherapy, such as     gemcitabine hydrochloride and alvocidib, use different ways to stop tumor cells from dividing     so they stop growing or die. Combining more than one drug may kill more tumor cells   "
170692|NCT00072449|"     RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells.      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have     refractory or relapsed primary CNS lymphoma.   "
170693|NCT00072462|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It     is not yet known whether tamoxifen is more effective than anastrozole in preventing breast     cancer after surgery for ductal carcinoma in situ.      PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works     compared to anastrozole in treating postmenopausal women who have undergone surgery to remove     ductal carcinoma in situ.   "
170694|NCT00072475|"     RATIONALE: Vatalanib may be effective in preventing the development of leukemia in patients     who have myelodysplastic syndromes.      PURPOSE: This phase II trial is studying vatalanib to see how well it works in treating     patients with primary or secondary myelodysplastic syndromes.   "
170695|NCT00072488|"     RATIONALE: New imaging procedures, such as whole-body MRI, may improve the ability to detect     metastatic cancer and determine the extent of disease.      PURPOSE: This clinical trial is studying whole-body MRI to see how well it works compared to     standard imaging procedures in detecting distant metastases in patients with solid tumors or     lymphoma.   "
170696|NCT00072501|"     RATIONALE: Screening tests such as ultrasound and mammography may help doctors detect cancer     cells early and plan more effective treatment for breast cancer. It is not yet known whether     ultrasound is more effective than mammography in detecting breast cancer.      PURPOSE: This clinical trial is studying breast ultrasound to see how well it works compared     to mammography in detecting cancer in women who are at high risk for breast cancer.   "
170697|NCT00072514|"     This pilot phase II trial studies the side effects and how well giving gemcitabine     hydrochloride, carboplatin, dexamethasone, and rituximab together works in treating patients     with previously treated lymphoid malignancies. Drugs used in chemotherapy, such as     gemcitabine hydrochloride, carboplatin, and dexamethasone, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Giving more than one drug (combination     chemotherapy) and giving monoclonal antibody therapy with chemotherapy may kill more cancer     cells   "
170698|NCT00072527|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, irinotecan, carboplatin, and     etoposide, use different ways to stop tumor cells from dividing so they stop growing or die.     Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with     radiation therapy may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of cisplatin and irinotecan followed by     carboplatin, etoposide, and radiation therapy in treating patients who have limited-stage     small cell lung cancer.   "
170699|NCT00072540|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. Celecoxib may be effective in preventing cervical cancer.      PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing     cervical cancer in patients who have high-grade squamous intraepithelial lesions of the     cervix.   "
170700|NCT00072553|"     RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, use     different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may     stop the growth of colorectal cancer by stopping blood flow to the tumor and by blocking the     enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib may kill more     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining celecoxib with leucovorin,     fluorouracil, and oxaliplatin in treating patients who have metastatic colorectal cancer.   "
170701|NCT00072566|"     This phase II trial is to see if combining bevacizumab with low-dose cyclophosphamide works     in treating patients with ovarian epithelial or primary peritoneal cancer that has come back     or spread to other parts of the body. Monoclonal antibodies, such as bevacizumab, can block     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.     Others find cancer cells and help kill them or deliver cancer-killing substances to them.     Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor     cells from dividing so they stop growing or die. Combining bevacizumab with cyclophosphamide     may kill more tumor cells.   "
170704|NCT00072605|"     This study will test the safety of an experimental vaccine developed to protect against Ebola     virus infection and to determine if the vaccine induces an immune response to the virus. The     Ebola virus causes a disease called Ebola hemorrhagic fever. Symptoms begin with fever and     muscle aches and progress to breathing problems, severe bleeding, kidney problems, and shock.     The infection may be mild, but it can also lead to death. The vaccine used in this study is     made from small parts of Ebola genetic material. It cannot cause Ebola hemorrhagic fever to     develop in those who receive it.      Healthy volunteers 18 to 44 years of age may be eligible for this study. Candidates will be     screened with a medical history, physical examination, and laboratory tests, and complete an     assessment of understanding questionnaire to show that they understand the study.      Depending on their order of entry into the study, participants are assigned to receive one of     three vaccine doses or placebo. The first group receives the lowest dose (2 milligram) of     vaccine or placebo. If this dose is safe, then the second group receives 4 mg, and if this     dose is safe, the third group receives 8 mg. Injections are given in a muscle in the upper     arm. Participants receive three injections, each 4 weeks apart (on study days 0, 28, and 56).      Participants record their temperature and symptoms in a diary card for 7 days following each     injection. They return to the clinic 2 to 3 days after each injection and then 2 weeks after     each injection until study week 10. Additional follow-up visits are then scheduled at weeks     12, 24, 38, and 52. At each visit, participants provide a blood and urine sample for testing     and have their vital signs, and lymph nodes checked, their weight measured, and their     symptoms reviewed. Additional laboratory tests may be requested between visits.   "
170707|NCT00072644|"     This study will evaluate the impact of the HIV protease inhibitor ritonavir on the     pharmacokinetics-that is, the interaction of the medication and the body-of prednisolone     after prednisone is given to healthy volunteers. Prednisone, an agent known as a     corticosteroid, or steroid hormone, is converted by the body into prednisolone. Ritonavir is     an HIV medication that fights the virus by blocking its ability to reproduce. Sometimes it     increases the blood levels of other drugs given at the same time, and it is possible that     ritonavir increases the blood levels of prednisolone and those of other medications. Results     from the study will provide information on whether prednisone and ritonavir interact in a     potentially harmful way. The MDR1 genotype, that is, part of a person's genetic constitution,     may influence how prednisolone behaves.      Patients 18 to 50 years of age who are in good health, who not have HIV, and who do not smoke     may be eligible for this study. There will be 10 participants and another 5 later who will be     control subjects. Those in the control group will take only prednisone, not ritonavir.      Participants will undergo the following tests and procedures:        -  Medical history and physical examination.        -  Collection of blood and urine to assess general health.        -  Collection of blood to examine markers on white blood cells and to determine the kind of          MDR1 gene was inherited.        -  HIV test.      The screening visit will take about 3 to 4 hours, and the study will take about 28 to 49     days. For 3 study days, participants will remain in the clinic for 12 hours, On Study Day 1,     patients will be asked to not eat or drink anything besides water before coming to the     clinic. Blood samples will be collected to measure prednisolone concentration as well as     osteocalcin, a blood protein involved in bone formation. Blood tests will also allow a look     at the surfaces of some white blood cells. Patients will receive a breakfast along with 20 mg     of prednisone. Urine samples will be collected also. Then patients will be dismissed and     asked to collect urine samples and return them on the following morning, Study Day 2. At that     time there will additional blood collection. Patients will begin taking ritonavir between 7     and 28 days after the first dose of prednisone, at a dose of 200 mg (two 100 mg capsules)     twice daily with food, to continue for 15 days. On the 4th and 14th days of their taking     ritonavir, patients will be asked to visit the clinic in the morning for a blood to measure     ritonavir in the blood and to take a single 20-mg dose of prednisone along with the     ritonavir. Both medications will be taken with breakfast. Blood and urine levels of     prednisolone will also be measured. On the 15th day of ritonavir dosing, there will be     another blood collection for routine lab tests, as well as studies on blood cells and     osteocalcin.   "
170708|NCT00072657|"     Rheumatoid arthritis (RA) is a chronic illness. Patients with RA often experience significant     pain and depression. This study will evaluate two programs designed to improve the symptoms     of RA: cognitive-behavioral therapy (CBT) and Tai Chi Chih (TCC), compared to a health     education seminar.   "
170709|NCT00072670|"     The purpose of this study is to evaluate safety and efficacy of trabectedin (ET-743) in adult     male participants with advanced metastatic (spread of cancer cells from one part of the body     to another) prostate cancer.   "
170710|NCT00072683|"     This study’s purpose is to determine whether tolvaptan can safely and effectively return the     body’s balance of sodium and water toward normal, and to characterize and quantify the     potential clinical benefits of this treatment.   "
170711|NCT00072709|"     This is a global multicenter study designed to evaluate the safety and clinical effects of 4     oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or     mild to moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks),     run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24     weeks).   "
170712|NCT00072722|"     Phase II randomized open-label, two-arm study of safety and efficacy of CC-4047 in subjects     with metastatic hormone refractory prostate cancer (HRPC)   "
170713|NCT00072735|"     This study will examine the role of an amphetamine in improving the effect that electrical     nerve stimulation has over brain flexibility associated with motor training in patients who     experienced a stroke more than 1 year before. Chronic stroke is the main cause of long-term     disability among adults. Previous studies have shown that electrical stimulation given over     the skin may improve patients' recovery of motor function. Furthermore, it is known that     amphetamines can improve the effects of sensory stimulation such as touch. Use dependent     plasticity refers to a process in which the performance of simple, repetitive finger     movements leads to encoding the details of those actions in the primary motor cortex of the     brain. Plasticity in this sense refers to the capacity for change in the brain.      Patients 18 years of age and older who have had a stroke, who have no history of other     neurological and psychiatric illnesses, and who are able to contrite and perform simple     attentional tasks and other tasks may be eligible for this study. There will also be healthy     participants as a control group.      Participants will have an electrocardiogram. They will also go through a practice session of     about 3 hours in which they become familiar with the different tasks required in the study:     motor training, pinch force, and the Jebsen-Taylor Test-which requires doing as fast as     possible actions that include writing, lifting small common objects, turning pages, or     lifting light or heavy objects. Then during the study, patients will be involved in a variety     of sessions:        -  Motor training alone for about 3 hours.        -  Motor training, amphetamine (or placebo), and electrical stimulation for about 6 hours.        -  Motor training, amphetamine, and no electrical stimulation for about 6 hours.      A magnetic resonance imagining (MRI) scan will be done. Patients will lie still on a table     that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning     time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes.     Patients may be asked to lie still for up to 60 minutes at a time. As the scanner takes     pictures, there will be loud knocking noises, and the patients will wear earplugs to muffle     the sound. Patients will be able to communicate with the MRI staff at all times during the     scan and may ask to be moved out of the machine at any time.      During another procedure called transcranial magnetic stimulation (TMS), a wire coil will be     held over the scalp. A brief electrical current will be passed through the coil, creating a     magnetic pulse that stimulates the brain. Patients will hear a click and may feel a pulling     sensation on the skin under the coil. There may be muscle twitches of the face, arm, or leg.     Patients may be asked to tense certain muscles slightly or perform other simple actions so     that the coil can be positioned appropriately. The stimulation is usually not painful,     although sometimes strong contractions of the scalp muscles can cause discomfort or a     headache. Patients can ask to have the procedure discontinued at any time.      For the electrical stimulation procedure, three pairs of electrodes will be placed on the     skin. A quite brief pulse of current will pass between the electrodes, creating the     electrical field that activates the brain. Patients will feel a brief stinging around the     electrodes. Regarding the amphetamine, patients will take it orally on up to four different     occasions. Usually they will take 10 mg of Dexedrin before testing.   "
170714|NCT00072748|"     This non-randomized, open-label, outpatient clinical trial is designed to assess the safety     and efficacy of daily orally administered EKB-569 in subjects with advanced colorectal     cancer. Patients must have been previously treated with a fluoropyrimidine (5-FU or     capecitabine) and either oxaliplatin or irinotecan (given concurrently or as separate     regimens).      The primary objective of the study is to assess the clinical activity of EKB-569 administered     orally as a second-line or later stage treatment in subjects with advanced colorectal cancer.      Secondary objectives include:        -  To further evaluate the safety of EKB-569        -  To explore additional clinical activity parameters        -  To explore subject survival        -  To evaluate the pharmacokinetics of EKB-569        -  To assess subject reported outcomes      EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569     daily as long as they do not have progressive disease and are tolerating treatment.   "
170715|NCT00072761|"     The goal of this study is to determine the effectiveness of blood transfusion therapy for     prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.   "
170716|NCT00072774|"     To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus     subjects receiving placebo.   "
170717|NCT00072787|"     The purpose of the phase 1 portion of the study is to determine the safe dose of S-1 and     cisplatin that can be administered in gastric cancer patients.      The purpose of the phase 2 portion of the study is to determine the antitumor activity of the     S-1 and cisplatin regimen established from phase 1 in patients with advanced gastric cancer.   "
170749|NCT00073216|"     To prevent HIV infection, a vaccine that produces strong HIV-specific humoral (B-cell) and     cellular (T-cell) immune system responses is desirable. The purpose of this study is to test     the safety of and immune response to a novel combination HIV vaccine in HIV uninfected     adults. This study will also test the safety of and immune response to a protein vaccine     given alone.   "
170750|NCT00073229|"     This observational study will evaluate data from infants born to HIV infected mothers in     order to better characterize disease progression in early HIV infection.   "
170718|NCT00072800|"     This study, conducted at the National Institutes of Health and the Children's National     Medical Center, will evaluate how well different physicians agree in how they classify     cerebral palsy subtypes based on patient examination. Cerebral palsy is divided into several     subtypes, according to the primary underlying muscle abnormality and its distribution and     severity. Classification of these subtypes is important for conducting rehabilitation     research studies on patients with the same type of abnormality. However, doctors do not     always classify cerebral palsy types in the same way. This study will examine methods for     improving agreement among doctors in their classification of cerebral palsy subtypes.      Children between 6 and 18 years of age with cerebral palsy who can voluntarily move their     arms and legs may be eligible for this study. Participants will be examined by at least three     doctors or therapists. The examinations take 30-60 minutes. For the examination, a doctor or     therapist will do the following:        -  Observe the patient at rest        -  Gently move the patient's arms and legs and then have the patient move his or her arms          and legs        -  Check the patient's reflexes        -  Observe the patient walking, if the patient is able to walk      Patients will be asked to remain in the clinic for up to 3 hours while researchers discuss     the examination and may be asked to repeat part of the study examination.   "
170863|NCT00074243|"     RATIONALE: Drugs used in chemotherapy, such as CC-8490, work in different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: Phase I trial to study the effectiveness of CC-8490 in treating patients who have     recurrent or refractory high-grade gliomas.   "
170719|NCT00072813|"     This study will examine the possible structural and functional abnormalities in patients with     an inherited form of epilepsy. It will use magnetic resonance imaging (MRI). Uncontrolled     epilepsy is a serious neurological problem with major harmful medical, social, and     psychological effects, as well as greater mortality compared with the general population. The     cost per year in the United States is at least $12.5 billion. There have been advances in     diagnosing the disease, but the cause cannot be determined in many cases. Recently, several     seizure syndromes found in families have been described. One syndrome of particular interest     involves the lateral temporal lobe of the brain and often includes auditory features.     Patients with that kind of syndrome may hear monotonous unformed sounds, but sometimes they     may hear complex sounds, such as a song.      Patients are eligible for this study if they have a specific form of familial epilepsy that     is being studied at Columbia University in New York. Family members without seizures are     eligible as well. All the patients in the study will be evaluated at Columbia before     participating. Healthy volunteers aged 18 to 55 also may be eligible for this study.      Participants will undergo a medical history and physical examination. During the study, they     may have three or four sessions of MRI. During the MRI, patients will lie still on a table     that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning     time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes.     Patients may be asked to lie still for up to 60 minutes at a time. As the scanner takes     pictures, there will be loud knocking noises, and the patients will wear earplugs to muffle     the sound. Patients will be able to communicate with the MRI staff at all times during the     scan and may ask to be moved out of the machine at any time. Some scans may be done in a 3     Tesla scanner. It is the latest advance in MRI, with a stronger magnetic field than in the     more common 1.5 Tesla scanner. Functional MRI (fMRI) is done while patients are performing     tasks, such as moving a limb or speaking. Patients will have an opportunity to practice such     tasks before entering the scanner. The fMRI will take about 1 hour.   "
170720|NCT00072826|"     This study will examine the effects of oral atorvastatin on the linings of blood vessels in     patients with sickle cell disease, plus the agent's effect on blood markers of inflammation     and blood vessel function. Sickle cell disease is a recessive genetic disorder and the most     common genetic disease affecting African Americans. Inherited are abnormal genes that make     hemoglobin, the substance within red blood cells that carries oxygen from the lungs to the     body. In the disease, sickle hemoglobin leads to rigidity or hardness of the red cells,     causing obstruction in small blood vessels, inflammation, and injury to organs when the flow     of blood to them is blocked. Some medications already prescribed for other diseases, such as     atorvastatin, which is used for lowering cholesterol levels, can improve blood flow.      Patients 18 to 65 years of age who have sickle cell disease, who have not had an acute pain     episode within the previous week, and who are not pregnant or lactating may be eligible for     this study. They will undergo a complete medical history; physical examination; baseline     blood tests; and echocardiogram, in which an ultrasound wand is placed against the chest wall     to get images inside the heart and blood vessels.      In addition, patients will have blood flow studies. During the procedure, they will lie in an     adjustable reclining chair for 5 to 6 hours. There will be 20- to 30-minute rests between     specific activities and blood samples will be drawn intermittently for testing. Small tubes     will be placed in the artery of the forearm at the inside of the elbow. Normal saline will be     infused into one tube. A small pressure cuff will be applied to the wrist and a larger cuff     to the upper arm. Both cuffs will be attached to an inflation device. A device like a rubber     band, a strain gauge, will be placed around the widest part of the forearm. When the pressure     cuffs are inflated, blood will flow into the arm, stretching the gauge proportion to blood     flow, and information will be recorded. Then light reflected from the patients' hand and the     blood flow in the forearm will be measured. Activity of the genes in the white blood cells     will be measured as well. Small amounts of sodium nitroprusside, widely used to reduce blood     pressure in people with dangerously high blood pressure, will be injected and blood flow will     be measured. Later, small amounts of acetylcholine will be injected. It usually causes blood     vessels to expand. After that, small amounts of L-NMMA will be injected. It usually decreases     local blood flow by blocking the production of nitric oxide in the cells lining the arm's     blood vessels. Then acetylcholine combined with L-NMMA will be injected. After that,     oxypurinol, an agent taken by many patients to prevent gout, will be injected. The procedures     will be repeated, with oxypurinol given along with each of the agents, and the measurement of     blood flow in the forearm will be measured after each drug combination.      Afterward, patients will be treated for 4 weeks at home with oral atorvastatin. They will be     asked to visit the Clinical Center every 2 weeks for collection of blood samples and an     examination. After 4 weeks of taking atorvastatin orally, they will be asked to return to     repeat the blood flow studies, but only the first half will be conducted. The part using     oxypurinol will not be needed. Regarding some of the blood samples collected during the     study, there will be an examination of the genes found in the white blood cells. Specific     attention will go to those genes that make proteins for cell-to-cell interaction and     inflammation, plus those that cause blood cells to stick to the lining of blood vessels.   "
170721|NCT00072839|"     The purpose of the study is to determine whether an investigational compound, ALX-0600, is     safe and effective in treating Crohn's Disease.   "
170722|NCT00072852|"     The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules     of single-agent Irinotecan in women with metastatic breast cancer who have experienced     failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will     receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3     week cycles.   "
170723|NCT00072865|"     This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of     determining the efficacy of the combination in tumor reduction, in patients with locally     advanced or metastatic breast cancer.   "
170724|NCT00072891|"     This study is designed to study how adults with Type 2 Diabetes and either high blood     pressure and/or high blood cholesterol manage their treatment regimen. It is also called the     Diabetes Management Study. Individuals need to be 40 years of age or older and on oral     medication (pills) management for two of the three conditions of interest. They may also be     on other treatment such as insulin, diet and/or exercise programs. Individuals will be     followed for approximately 12 months. About 1/4 of the persons in the study will receive a     telephone counseling program with a nurse focused upon their management of their treatment     program.   "
170725|NCT00072904|"     To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting     hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing     the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize     pulmonary function in cystic fibrosis (CF).   "
170726|NCT00072917|"     This is a longitudinal cohort study of how the responses to a 3 day period of controlled     overfeeding relate to subsequent weight gain. We hypothesize that thin individuals are     resistant to weight gain because they respond to periods of overfeeding by increasing fat     oxidation, reducing food intake, and increasing physical activity relative to those who gain     weight over time.   "
170727|NCT00072930|"     The primary objectives of this study are:        1. To explore the antitumor activity of MEDI-522 in combination with docetaxel, prednisone,          and zoledronic acid in patients with metastatic Androgen-Independent Prostate Cancer          (AIPC); and        2. To summarize the safety of MEDI-522 in combination with docetaxel, prednisone, and          zoledronic acid in this patient population.   "
170728|NCT00072943|"     The purpose of the HARMONY study is to assess the safety and efficacy of an investigational     drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a     humanized anti-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks     IFN-γ, a protein in the immune system that is involved in inflammation. Antibodies are     proteins normally produced by our immune system to help fight off foreign substances.     Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the     antibodies in our bodies, to target diseases.   "
170751|NCT00073242|"     Our previous studies have demonstrated that there is substantial metabolic opposition to the     maintenance of an altered body weight. Leptin is a protein secreted by fat cells and the     circulating concentrations of leptin are directly proportional to fat mass. Leptin-deficiency     is associated with severe obesity in rodents and in humans and the obesity is relieved by     leptin administration. These studies examine the hypothesis that some of this metabolic     opposition cto the maintenance of an altered body weight can be relieved by restoring     circulating concentrations of the hormone leptin to the same range as at usual body weight in     subjects who are maintaining a reduced body weight. The basic design of this study is to     observe subjects at a 10% reduced body weight and then again at that reduced body weight     while receiving physiological leptin or T3 supplementation.   "
170755|NCT00073294|"     This is a pilot study to examine the prevalence of metabolic risk factors (impaired insulin     release and impaired insulin sensitivity) for type 2 diabetes mellitus in children and adults     from a population that is at high risk for this disease. We hypothesize that at least one of     these pre-diabetic traits will be evident in a large proportion of relatives of known type 2     diabetic children as compared to a control group of subjects without a family history of type     2 diabetes. By isolating these traits, it will be possible to determine the relative     contributions of genes and environment to each trait and to identify those at risk for     subsequent development of type 2 diabetes by virtue of having one trait. Ultimately, those     individuals at risk, especially those with impaired insulin release, would hopefully benefit     from intervention to prevent the weight gain that will 'unmask' their underlying pancreatic     dysfunction and thus prevent or retard the development of type 2 diabetes.   "
170756|NCT00073307|"     The purpose of this study is to evaluate safety, efficacy (including quality of life), and     pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with     unresectable and/or metastatic renal cell cancer, who have received one prior systemic     regimen for advanced disease.   "
203348|NCT00502918|"     The study is a feasibility study to check the possibility of tracking the heart rate of the     fetus and to translate the outcome to the progress of the labor   "
170729|NCT00072956|"     This study will examine the action of sensory tricks on an occurrence known as surround     inhibition when there is a disorder of muscle tone affecting a single body part in isolation.     Surround inhibition refers to a situation that suppresses unwanted movements, known as     dystonia, in surrounding muscles during voluntary actions. There are tricks-various     actions-that people use to temporarily stop those unwanted movements. Such tricks can include     touching the affected body part, placing an object in the mouth, pulling the hair, and     others. Often these tricks are beneficial early in the illness but become less effective as     it progresses. This study is guided by a hypothesis that sensory tricks will restore surround     inhibition and by another hypothesis that it is the application of the tricks, not simply     sensory input, that is effective in doing that restoring. Emphasis is on cervical dystonia,     involuntary actions affecting the neck, in which the tricks commonly involve the cheeks and     chin. The technique used in the study is transcranial magnetic stimulation (TMS).      Patients ages 18 and older who have cervical dystonia with at least one effective trick and     patients with no effective trick may be eligible for this study. There will also be a control     group of healthy participants.      Participants will be asked to show the sensory trick and may be asked to be videotaped.     During the TMS procedure, they will be seated in a comfortable chair, with hands placed on a     pillow on the lap. Small electrodes-soft strips that stick to the skin-will be placed on the     skin to record the electrical activity of some muscles in the neck that are activated by the     stimulation from TMS. In TMS, there will be a wire coil held over the scalp. A brief     electrical current will be passed through the coil, creating a magnetic pulse that stimulates     the brain. Patients will hear a click and may feel a pulling sensation on the skin under the     coil. There may be muscle twitches of the face, arm, or leg. In addition, patients may be     asked to tense certain muscles slightly or perform other simple actions so that the coil can     be positioned appropriately. Patients will sometimes be asked to bite down and tap their     teeth slightly for about 1-1/2 minutes at a time. They will be asked to show the sensory     trick. The stimulation is usually not painful, although sometimes strong contractions of the     scalp muscles can cause discomfort or a headache. Patients can ask to have the procedure     discontinued at any time. The testing session takes about 2 hours, done on an outpatient     basis.   "
170730|NCT00072969|"     This study will evaluate a new immunosupressive therapy, Daclizumab, and compare it with     antithymocyte globulin (ATG) to treat cytopenia, that is, the deficiency of cellular elements     of the blood, in myelodysplastic syndrome (MDS). Daclizumab is an anti-interleukin-2 receptor     (IL-2) antibody. MDS, also known as myelodysplasia, is a disorder that can cause anemia,     spontaneous bleeding, and greater risk of infections. Although the bone marrow can still     produce some blood cells, very few reach the bloodstream. The cause of MDS is not known,     although its behavior is. Many patients need transfusions of red blood cells. They may also     develop leukemia, which is often quite resistant to treatment with chemotherapy. However, the     progression of the disorder to leukemia is usually slow, taking many years.      Patients 18 years of age and older who have MDS may be eligible for this study. Participants     will undergo the following tests and procedures:        -  Medical history and physical examination.        -  Collection of blood for tests including blood counts, liver and kidney function, and          antibodies against common viruses.        -  Chest x-ray.        -  Electrocardiogram.        -  Bone marrow sample to confirm the diagnosis.      Participants will randomly receive either ATG or Daclizumab. If they are in the group to     receive ATG, they will be admitted as inpatients to undergo the first 10 to 14 days of     treatment. If they do not already have a catheter in one of the large veins of the neck,     chest, or arm, one will be placed. ATG will be given through the catheter. Blood counts and     other blood analysis will be monitored daily while the patients are treated. After about 10     days, they will be released, to be under the care of their referring physicians. Those     participants who are in the group to receive Daclizumab will receive a total of five doses,     one every 2 weeks, over 8 weeks, given through a vein as a 15-minute infusion. The first,     third, and fifth dose will be given at the outpatient clinic. The second and fourth doses can     be given either at the clinic or by the patients' primary hematologists.      All patients will be followed as outpatients at 3-month intervals for the first year, and     then every 6 months for the next 3 years. Afterward, follow-up will be yearly. A small sample     of blood will be drawn at the visits. Also, bone marrow examinations will be requested at the     6-month intervals for the first 3 years of treatment. If the treatment that patients are     assigned to does not work, after 6 months, they will be eligible to receive the other     treatment-provided that they have complied with the required blood tests and visits to the     clinic required to assess the patients' safety.   "
170731|NCT00072982|"     The object of this study is to determine whether treatment of rheumatoid arthritis (RA) with     a combination of fish oil and borage seed oil is superior to treatment with either oil alone.     This study will also investigate the biochemical, immunological, and molecular mechanism     responsible for the therapeutic effects of these fatty acids. Each patient will be followed     for eighteen months.   "
170732|NCT00072995|"     The purpose of this study is to test the effectiveness for weight loss and weight maintenance     of four diets differing in macronutrient composition: moderate in fat (40 percent energy)     with two different protein levels (15 percent and 25 percent), and low in fat (20 percent     energy), also with 15 percent and 25 percent protein levels. The study is only accepting     participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further     enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design     Narrative.   "
170733|NCT00073008|"     This study was designed to evaluate and compare the efficacy of two dose schedules of an oral     investigational drug for the treatment of advanced or metastatic non-small cell lung cancer.   "
170734|NCT00073021|"     This study is a prospective clinical study to evaluate the safety and efficacy of two     different doses of Asacol for the treatment of moderately active ulcerative colitis. In     addition, a new tablet formulation will be evaluated at one of the two doses.   "
170735|NCT00073034|"     EAA-090 is being developed for the treatment of neuropathic pain associated with diabetic     neuropathy. It is a selective antagonist that binds competitively to the glutamate site of     the N-methyl-D-aspartate (NMDA) receptor.      This study will assess the safety and efficacy of 3 fixed oral doses of EAA-090 compared with     placebo in subjects with neuropathic pain associated with diabetic neuropathy.   "
170736|NCT00073047|"     The purpose of The PROSPECT Study is to evaluate an investigational medication for the     treatment of moderate to severe ulcerative colitis. This study is being conducted at up to 38     clinical research centers in the US, Canada, and Belgium, and is open to male and female     patients 12 years and older. Participants in the study will have a number of visits to a     research center over a five-month period. All study related care and medication is provided     to qualified participants at no cost: this includes all visits, examinations, and laboratory     work.   "
170752|NCT00073255|"     To assess the tolerability and safety of hOKT3g1 (Ala-Ala) after a 12-day dosing regimen     administered via intravenous infusion. To assess the pharmacokinetics of hOKT3g1 (Ala-Ala).   "
170753|NCT00073268|"     This is a pilot study to examine the short-term effects of supervised exercise on metabolic     risk factors for type 2 diabetes mellitus in children from a population that is at high risk     for this disease. We hypothesize that exercise will significantly improve insulin sensitivity     in all children, especially in children who are already insulin resistant, thereby lowering     the risk that they will go on to develop type 2 diabetes mellitus. The specific hypotheses     being tested are:        1. Insulin resistance will be most evident in overweight children while an impaired ability          of the pancreas to release insulin will be most evident in children with a family          history of type 2 diabetes mellitus.        2. Exercise will significantly improve insulin resistance (as measured by the fasting          glucose/insulin ratio) with little or no effect on insulin secretory capacity (as          measured by circulating insulin concentration at 1, 3, and 5 minutes following an          intravenous glucose load) in children.        3. Participation in a school-based health, nutrition, and exercise education program will          have long-term beneficial effects on health-related behaviors and on insulin resistance.   "
170737|NCT00073060|"     This study will examine the effects of repeated apheresis procedures on bone density and     calcium balance. Apheresis is a procedure for collecting large numbers of a specific blood     component, such as white cells (leukapheresis) or platelets (plateletpheresis). For the     procedure, whole blood is collected through a needle in an arm vein and is directed through a     machine that separates it into its components by spinning. The desired cells are removed and     the rest of the blood is returned to the donor, either through the same needle or through a     needle in the other arm. A blood thinning medicine called citrate is added to the     cell-separating machine. Citrate reduces the ionized calcium levels in the blood, which     prevents the blood from clotting. When the blood is returned to the donor, the donor also     receives the citrate. This lowers the donor's ionized calcium levels which may irritate nerve     and muscle cells, causing tingling around the mouth, hands, and feet during the procedure.     The reduced ionized calcium levels result in increased parathyroid hormone levels in the     donor, can effect bone calcium stores. In addition, some of the citrate that is returned to     the donor is excreted in the urine along with calcium, which causes further loss of calcium     from the body. It is not known if the calcium loss during apheresis in people who undergo     this procedure repeatedly has any long-term effects on body calcium balance and bone calcium     stores. This study will measure bone density and calcium balance in long-term platelet and     white cell donors and compare the findings with those of whole blood donors, who do not     receive citrate.      Healthy people between 18 and 80 years of age who weigh between 110 and 300 pounds, do not     have a metal prosthesis, and are not pregnant may be eligible for this study. Participants     undergo the following procedures:      Whole blood donors        -  Blood sample collection 2 weeks before blood donation.        -  I removed undergo standard whole blood donation        -  Urine sample collection.        -  DEXA scan to assess bone density by measuring bone calcium stores. For this procedure,          the subject lies still on a table while the spine, hip, and whole body are scanned using          a small amount of radiation. The forearm is also scanned while the subject is seated.          The scan may be repeated after 2 years.      Plateletpheresis and leukapheresis donors        -  Standard platelet or white cell donation.        -  Blood sample collections immediately prior to and after donation, and on the first,          fourth, and fourteenth days after donation.        -  Urine sample collections at the beginning and at the end of the apheresis procedure and          on the first, fourth, and fourteenth days after the donation.        -  DEXA scan at the beginning of the study (no earlier than 2 weeks after their latest          apheresis donation). The scan may be repeated after 2 years.        -  Some apheresis donors may be asked to have a second procedure in which they take calcium          according to standard guidelines for plateletpheresis and leukapheresis. During the          second procedure, platelet donors will take oral calcium tablets before starting          plateletpheresis. White cell donors will receive calcium intravenously (through a vein)          during the second leukapheresis. For this second procedure, the donors provide          additional blood and urine samples as described above.   "
170738|NCT00073073|"     The primary goal of this 5-year study is to determine whether exemestane alone or in     combination with celecoxib decreases breast tissue density in healthy postmenopausal women at     high risk for breast cancer. Dense breast tissue seen on mammography has been linked to an     increased risk of breast cancer. The study will also examine the effects of exemestane and     celecoxib on bone density, blood hormone levels and quality of life. Exemestane, approved by     the Food and Drug Administration for treating postmenopausal women with breast cancer, lowers     the amount of estrogen in the body. Celecoxib, approved for treating arthritis pain and for     reducing the number or colon polyps in an inherited syndrome, is an anti-inflammatory drug.     Half of the women in the study will receive exemestane alone and half will receive exemestane     and celecoxib together.      In December 2004, the arm using exemestane and celecoxib was closed to accrual      Postmenopausal women who are at increased risk for developing invasive breast cancer may be     eligible to participate. Candidates are screened with breast cancer risk assessment, medical     history and physical examination, blood tests, review of medical records, if needed, breast     biopsy, and dual energy x-ray absorptiometry (DEXA) scan to assess bone density. For the DEXA     scan, the subject lies still on a table for about 30 minutes while the spine and hip are     scanned using a small amount of radiation.      Participants take exemestane in pill form once a day for 2 years. They also take calcium and     vitamin D pills daily to help protect bone health. They are followed in the clinic during the     course of the study to determine the amount of drug taken and any side effects, and for the     following tests and procedures:        -  Medical evaluation and blood tests at after 1 and 3 months on study drugs        -  Medical evaluation at 6 months        -  Breast biopsy at screening and then at 12 months        -  dual-emission x-ray absorptiometry (DEXA) scan of the spine, mammogram and routine blood          tests before starting study drugs and then yearly for 5 years.   "
170739|NCT00073086|"     This study will evaluate and treat people with SARS, a new type of pneumonia (lung infection)     originating in China. SARS is caused by a new virus that is easily transmitted from person to     person. This study will look at the course of the disease; determine how the virus affects     the body and how the body fights the infection; and evaluate diagnostic tests to quickly     identify the disease.      People 18 years of age and older with probable or suspected SARS may be eligible for this     study. Close contacts of patients with SARS, patients who recovered from SARS, and NIH health     care workers involved in the care of patients will also be enrolled. Patients with SARS who     require hospitalization will be admitted to the NIH Clinical Center. Because SARS spreads     easily, hospitalized patients will be in a room by themselves and will not be allowed any     visitors. They will not leave their room except for tests, such as x-rays.      All participants will have a full medical examination, including a medical history, physical     examination, and blood tests. In addition, the participants undergo various tests and     procedures as follows:        -  Probable and suspected SARS patients may be hospitalized or may be seen as outpatients.          They are provided the treatment judged best for their disease, usually according to          expressed or published recommendations. The best treatment for SARS is not yet known,          and there have been no studies evaluating therapies. Outpatients are seen three times a          week for 2 weeks, once a week for 4 more weeks, and then at 6 months. Patients have          mouth and throat swabs taken three times a week for the first 2 weeks, then once a week          for 4 more weeks. Blood is drawn three times a week for the first 2 weeks, then once at          weeks 3, 4, and 6. If virus is still detectable after 6 weeks, nose washings and throat          swabs are repeated until no virus is detected for 3 weeks in a row. In addition,          patients provide urine and stool samples, have a chest x-ray and electrocardiogram, and          undergo bronchoscopy and bronchial lavage. For the bronchoscopy, a bronchoscope          (pencil-thin flexible tube) is passed into the large airways of the lung, allowing the          physician to examine the airways. Cells and secretions from the airways are rinsed from          the lung with salt water. A brush the size of a pencil tip is passed through the          bronchoscope to scrape cells lining the airways and pieces of tissue are collected for          analysis.        -  Close contacts of patients are evaluated twice a week for 2 weeks, then once a week for          2 more weeks. Blood is drawn at the first visit and then at 1, 2, and 4 weeks. Mouth and          throat swabs, nose washings, and sputum collections are done twice a week for 2 weeks,          then once a week for 2 more weeks. Urine and stool samples are collected once a week for          4 weeks. If virus from the nose or throat is still detectable after 4 weeks, weekly nose          washings and throat swabs continue until no virus is detected for 3 weeks in a row.          Blood may also be drawn during the weekly visits.        -  Recovered SARS patients provide blood, urine, and stool samples and have a mouth and          throat swab and nose aspiration to see if the SARS virus is present. For the nasal          aspiration, salt water is put in the nose and then suctioned out. Usually, these tests          are done only once. If virus is detected, however, the nose washing, throat swabs and          blood tests are repeated once a week until no virus is detected for 3 weeks in a row.        -  Health care workers document their contact with patients, use of isolation procedures          and equipment, and any unexpected events that occur during contact. They are evaluated          for symptoms of infection and provide a blood sample once a month   "
170740|NCT00073099|"     Surface eye problems (problems of the cornea and conjunctiva), such as dry eye, are often     evaluated using ocular surface staining - the application of a colored dye to the surface of     the eye. The physician examines the nature, degree, and pattern of staining on the eye's     surface to determine the diagnosis, assess disease severity, and document treatment effects.     Grading of ocular surface staining is often used in research studies to measure the response     to a treatment or treatment side effects. Therefore, it is critical that the grading     methodology be reproducible and sufficiently detailed to detect changes in eye health status.     Current evaluation techniques using these dyes are somewhat subjective, however, since they     require human assessment and judgment. This study will assess the validity and reliability of     digital photography and compare it with standard slit lamp evaluation for analyzing ocular     surface dye staining to document surface eye damage in patients with dry eye.      Patients 3 years of age and older with dry eye may be eligible for this study. Participants     will have the following tests and procedures:        -  Visual acuity: (eye chart) test        -  Slit lamp evaluation: Examination of the front part of the eye with a special microscope          called a slit lamp biomicroscope. Special dyes derived from vegetables are instilled          into the eye to stain the surface of the eye where it is dry and damaged. The doctor          then determines the extent of staining. The staining will be repeated within one week of          the first examination.        -  Digital eye photography: Digital photographs of the eye are taken to aid in assessing          the extent of dry eye changes. The camera flashes a bright light for each picture. About          5 to 10 pictures are taken for each eye.   "
170741|NCT00073112|"     The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how     long the tumor shrinkage can be maintained in patients with renal cell cancer. Patients will     receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before     starting the next cycle of drug.   "
170742|NCT00073125|"     The primary objective of this study is to assess the safety and efficacy of ABT-510 in     subjects with advanced renal cell carcinoma.   "
170743|NCT00073138|"     The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how     long the tumor shrinkage can be maintained in patients with colorectal cancer. Patients will     receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before     starting the next cycle of drug.   "
170744|NCT00073151|"     The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how     long the tumor shrinkage can be maintained in patients with non-small cell lung cancer.     Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7     days before starting the next cycle of drug.   "
170745|NCT00073164|"     The purpose of this study is to assess the 14-day and 12-week safety and efficacy of Depakote     ER used in combination with either olanzapine or risperidone versus antipsychotic monotherapy     with olanzapine or risperidone for the treatment of schizophrenia.   "
170746|NCT00073177|"     The aim of the study is to compare the effects of oral roflumilast with placebo on lung     function in patients with asthma.   "
170747|NCT00073190|"     Osteoporosis is an important public health problem. Osteoporosis can cause serious health     complications and death and leads to increased medical costs. The purpose of this study is to     identify an effective method of educating patients and health care professionals about the     diagnosis and treatment of osteoporosis.   "
170748|NCT00073203|"     The purpose of this research study is to determine the effectiveness of 2 target doses of     R228060 in comparison with placebo during 6 weeks of treatment in moderately to severely     depressed adult subjects with major depressive disorder.      Approximately 488 subjects will be involved in the study.   "
170763|NCT00073398|"     This 2-phase study will determine the safety of treating patients with non-small cell lung     cancer with the genetically engineered HyperAcute-Lung cancer vaccine. It will establish the     proper vaccine dose and will examine side effects and potential benefits of the treatment.     The vaccine contains killed lung cancer cells containing a mouse gene that causes the     production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the     immune response to the foreign substance will stimulate the immune system to attack the     patient's own cancer cells that have similar proteins without this sugar pattern, causing the     tumor to remain stable or shrink.      Patients 18 years of age or older with non-small cell lung cancer that has recurred or no     longer responds to standard treatment may be eligible for this study. Candidates will be     screened with a medical history and physical examination, blood tests, urinalysis, chest     x-rays, and lung function testing. CT, MRI, PET, and ultrasound scans of the chest may be     obtained if needed.      Participants will receive four vaccinations a month apart from each other. The vaccines will     be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of     the study will treat successive groups of patients with increasing numbers of the vaccine     cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will     look for any beneficial effects of the vaccine given at the highest dose found to be safe in     Phase I. Weekly blood samples will be drawn during the 4 months of vaccine treatment. In     addition, patient follow-up visits will be scheduled every 2 months for the first year after     vaccination and then every 3 months for the next 2 years for the following tests and     procedures to evaluate treatment response and side effects:        -  Medical history and physical examination        -  Blood tests        -  X-rays and various scans (nuclear medicine/CT/MRI)        -  FACT-L Assessment questionnaire to measure the impact of treatment on the patient's          general well-being. The questionnaire is administered before beginning treatment, before          each vaccination, and during follow-up visits after completing the treatment. It          includes questions on the severity of lung cancer symptoms and the ability to perform          normal activities of daily life.      In addition to the above procedures, 3 skin punch biopsies will be done at the vaccination     site to look for a local immune response. For this procedure, an area of skin is numbed with     an anesthetic and a 4 mm (about 1/4-inch) circular area is removed, using a sharp cookie     cutter-type instrument. Also, one blood sample per year will be collected for the next 15     years to monitor the safety of the gene transfer. Patients whose lung cancer spreads to the     skin, superficial soft tissues, or a superficial lymph node may be asked to undergo a biopsy     of the lesion to see what effect the treatment may be having on the tumor.   "
170764|NCT00073411|"     The purposes of this study are to determine:        -  The safety of duloxetine and any side effects that might be associated with it.        -  How duloxetine compares to escitalopram and placebo (an inactive ingredient)   "
170765|NCT00073424|"     Taking anti-HIV medication consistently and properly is a critical issue for patients with     HIV. Drug regimens are complex; when regimens are not taken properly, HIV can become     resistant to the drugs. Taking anti-HIV medication properly leads to improved health.     Children and adolescents with HIV face unique challenges to taking HIV medication properly.     This study will look at the relationship between how children cope with the responsibility     for taking medication and the child's language, memory, attention, behavior, and academic     skills. This study is open to children and adolescents who are currently enrolled in the     PACTG 219C study (Long-Term Effects of HIV Exposure and Infection in Children).   "
170766|NCT00073437|"     The purpose of this study is to evaluate the safety and effectiveness of infliximab     (Remicade) in patients with Chronic Sarcoidosis. Infliximab (Remicade) targets specific     proteins in the body's immune system to help control the development of inflammation to help     reduce painful disease.   "
170767|NCT00073450|"     The purpose of this study is to determine the safety and efficacy of an oral Farnesyl Protein     Transferase Inhibitor (Lonafarnib/SCH 6636) as a single agent in Adult Patients With Squamous     Cell Carcinoma of the Head & Neck and will help determine if further development is     justified.   "
170768|NCT00073463|"     The purpose of this study is to confirm the improvement in pulmonary function and cytokine     levels observed in the recently completed multidose aerosol study for the treatment of Cystic     Fibrosis (CF).   "
170769|NCT00073476|"     The purpose of this study is to determine whether a new research medication is effective and     safe for the treatment of acute stroke when given within 6 hours of the onset of stroke.   "
170770|NCT00073489|"     The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL     patients.   "
170771|NCT00073502|"     Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety     of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit     after two cycles may be switched to a commonly used combination regimen.   "
170772|NCT00073515|"     This trial is for patients with a central venous catheter (a vascular access device) that is     not functioning properly (unable to withdraw blood). The trial compares a new blood clot     dissolving agent (alfimeprase) against the currently used treatment.   "
170774|NCT00073541|"     EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000     blocks a factor found on the surface of many cancer cells. The factor is called epidermal     growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian     cancer. This study will test the safety and effects of EMD 72000 in subjects with     EGFR-positive recurrent ovarian cancer following standard treatment that has failed.   "
170775|NCT00073554|"     This trial is for patients with acute occlusion of one of the arteries supplying blood to the     leg. The trial is designed to determine the safety and activity of a novel clot dissolving     (thrombolytic) drug (alfimeprase).   "
170776|NCT00073580|"     The purpose of this study is to examine the safety and efficacy of Angiomax as an     anticoagulation in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced     thrombocytopenia with thrombosis syndrome (HITTS) undergoing off-pump coronary artery bypass     (OPCAB) surgery.   "
170777|NCT00073593|"     The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative     anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary     artery bypass graft surgery.   "
170798|NCT00073866|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Celecoxib may stop the growth of tumor cells by stopping blood flow     to the tumor. Combining celecoxib with combination chemotherapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan and     docetaxel when given together with celecoxib and to see how well they work in treating     patients with advanced non-small cell lung cancer.   "
170799|NCT00073879|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, use     different ways to stop cancer cells from dividing so they stop growing or die. Peripheral     stem cell transplantation may be able to replace immune cells that were destroyed by     chemotherapy. Sometimes the transplanted cells can reject the body's normal tissues.     Alemtuzumab and tacrolimus may prevent this from happening.      PURPOSE: Phase II trial to study the effectiveness of combining fludarabine and     cyclophosphamide with alemtuzumab in treating patients who are undergoing allogeneic stem     cell transplantation for recurrent or metastatic renal cell carcinoma (kidney cancer).   "
170778|NCT00073606|"     This study will examine the role of the spinal cord in improving leg movements after physical     training in healthy people. The results of this study may be helpful in developing new     rehabilitation therapies for people with impaired leg function.      Healthy volunteers between 21 and 65 years of age may be eligible for this study. Candidates     will be screened with a brief medical history and physical examination.      Participants will undergo EMG-H reflex measurement while pedaling on a stationary bicycle.     For this test, the subject is given an electrical stimulation at the nerve at the back of the     knee while pedaling on a stationary bicycle. The shock produces a jerky movement called the     H reflex. The muscular activity causing these reflexes is measured using electrodes (small     metal disks) filled with a conductive gel and taped to the skin over the calf muscle. The     nerve is stimulated at four different frequencies during the experiment. While cycling, pedal     resistance changes, making it harder or easier to pedal.      On study day 1, participants have EMG-H reflex measurement to determine baseline performance,     then a training session to prepare for the actual test, and then a post-training test to     measure performance again. The test is repeated on days 2, then between days 5 and 8, and     again between days 11 and 14. The screening and first visit last 2 hours; the remaining test     visits are 1 hour each. The bicycling time is only 15 minutes during training and 5 minutes     at each test session.   "
170779|NCT00073619|"     This study will determine the effectiveness of a cognitive-behavioral group therapy program     in preventing anxiety disorders in at-risk children exposed to community violence.   "
170780|NCT00073632|"     This study will develop and implement an awareness- and acceptance-based for treatment of     individuals with generalized anxiety disorder.   "
170781|NCT00073645|"     This study will compare the effectiveness of family- and peer-oriented therapy in treating     children with anxiety disorders and will also test for therapy specificity effects and     potential mediators of outcome.   "
170782|NCT00073658|"     This study will compare the safety and effectiveness two medications, citalopram (Celexa®)     and risperidone (Risperdal®).   "
170783|NCT00073671|"     This study examines the impact of a group cognitive behavioral program aimed at preventing     depressive disorders and symptoms in adolescents at risk for developing depression.   "
170784|NCT00073684|"     This study will determine the necessity of including abuse-focused interventions in the     treatment of sexually abused children.   "
170785|NCT00073697|"     This study will determine how certain features of depressed individuals affect their     responses to depression treatment.   "
170786|NCT00073710|"     A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption     in hemodialysis subjects.   "
170787|NCT00073723|"     The anticancer agent paclitaxel (Taxol for Injection Concentrate, Bristol-Meyers Squibb) has     a broad spectrum of activity against several human cancers including carcinomas of ovary,     breast, lung, esophagus and head and neck cancer. Taxol has shown remarkable activity against     metastatic breast cancer, yielding response rates in the range of 40% to 60% in     chemotherapy-naive patients and 25%-30% in patients refractory to anthracycline-containing     regimens (Taxol package insert). The major limitation of Taxol is its poor water soluability     requiring Cremophor (containing castor oil and ethanol) as a solvent. Taxol in this vehicle     must be administered over 3-24 hours, and hypersensitivity reactions to Cremophor require a     premedication routine of a corticosteroid, an antihistamine, and an H2 antagonist.   "
170788|NCT00073736|"     Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. MB07133 is     being developed for the treatment of inoperable HCC, using a platform technology known as     HepDirectTM, which enables drugs to be targeted specifically to the liver. The objective for     this study is to determine the safety and tolerability of MB07133.   "
170789|NCT00073749|"     To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety     profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).   "
170790|NCT00073762|"     Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving     DVS-233 SR versus subjects receiving placebo.      Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical     global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton     Psychiatric Rating Scale for Depression, 17-item [HAM-D17] less than or equal to 7) versus     those subjects receiving placebo.   "
170791|NCT00073775|"     To examine the effects of psychological stress on the metabolic syndrome.   "
170792|NCT00073788|"     To evaluate Post-Traumatic Stress Disorder as a risk factor for cardiovascular disease in     American Indians.   "
170793|NCT00073801|"     This study will examine pelvic pain associated with endometriosis and explore better     approaches to treatment. In women with endometriosis, uterine tissue grows outside the     uterus. Standard treatments - altering hormone levels to prevent endometrial tissue growth or     surgically removing endometrial tissue - treat pelvic pain only temporarily. This study will     investigate the role of sex hormones, immune chemicals, stress hormones, and genes in pelvic     pain and determine how the nerve, muscle, and skeletal systems are involved in this pain.      Women between 18 and 50 years of age who:        1. have endometriosis and chronic pelvic pain, and        2. have chronic pelvic pain without endometriosis, and        3. have neither endometriosis nor chronic pelvic pain and are willing to have a tubal          ligation (Healthy Volunteer group),      may be eligible for this study. Candidates are screened with a questionnaire to obtain     information about their pain and previous treatments and related medical or social issues.     Participants will undergo the following tests and procedures:        1. Medical history and physical examination, including pelvic exam, blood tests,          urinalysis, and diaphragm fitting.        2. Questionnaires about pain, quality of life, sexuality, psychological attitudes,          spiritual experiences, and history of headache and depression.        3. At-home monitoring for 4 to 6 weeks of pain symptoms, menstruation and spotting,          medicines taken, and urine collections to test for LH surge. LH is the hormone that          causes the ovary to release a mature egg.        4. Pre-laparoscopy evaluation to include:             -  Examination of menstrual blood collected in a diaphragm for 4 hours.             -  Blood sampling to measure adrenal and pituitary hormones. For this test,               corticotrophin-releasing hormone (CRH) is injected through an IV needle. Up to five               blood samples are drawn, starting before the injection until 45 minutes after it.               Blood is also collected at this time for genetic analysis.             -  In-depth pain assessment to identify trigger points in muscles associated with               pelvic pain, regions of skin sensitivity, and bone pain. Some women will undergo               microdialysis, which uses an acupuncture-type needle to collect chemicals from two               different muscles.             -  Blood sampling twice a week for 1 month to measure changes in blood substances               during the menstrual cycle.             -  Blood sampling after the LH surge to measure progesterone levels.             -  Cervicovaginal lavage (washing of the cervix with saline and collecting the fluid)               to obtain secretions for research.             -  Ultrasound of the ovaries and uterus. This examination uses a probe inserted into               the vagina that emits sound waves that are used to form pictures of the internal               structures. A small piece of uterine lining is also obtained for examination and               research purposes.             -  A visit with the members of the Pain and Palliative care service to evaluate the               pain in anticipation of offering other treatments for pain after surgery.             -  Surgery:      CPP + Endo or CPP only: Laparoscopy to look for and remove endometrial tissue. This procedure     is done under general anesthetic. A viewing instrument called a laparoscope is passed through     an incision in the belly button to look for endometriosis. If it is found, two or more     incisions are made in the abdomen for other instruments to remove the tissue. A small piece     of uterine lining is also obtained for examination and research purposes.      Healthy Volunteers: Laparoscopy to perform the tubal ligation. A tubal ligation, commonly     known as getting your tubes tied, is a surgical procedure for women to sterilize them. This     procedure closes the fallopian tubes, stopping the egg from traveling from the ovary to the     uterus and preventing sperm from reaching the fallopian tube to fertilize an egg. In a tubal     ligation, fallopian tubes are cut, burned, or blocked with rings, bands or clips. The surgery     is effective immediately. Tubal ligations are 99.5% effective as birth control. This     procedure is done under general anesthetic. A viewing instrument called a laparoscope is     passed through an incision in the belly button to perform a tubal ligation. Two or more     incisions are made in the abdomen for other instruments to perform the procedure. During the     laparoscopy, we will look for and remove endometrial tissue. A small piece of uterine lining     is also obtained for examination and research purposes.      -Follow-up evaluations. Two weeks after surgery, patients return to NIH to discuss the     surgical findings and treatment options. Follow-up visits are then scheduled at 1, 3, and 6     months after surgery to complete questionnaires and determine if the treatment is working.     Blood samples are drawn at each visit.   "
170794|NCT00073814|"     Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects     with Asthma   "
170795|NCT00073827|"     The primary purpose of this study was to investigate the efficacy of levalbuterol compared to     a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in     adolescent and adult subjects with asthma, with all treatments administered 4 times a day     (QID).   "
179478|NCT00184509|"     The purpose of this study was to determine whether outreach integrated treatment of first     episode schizophrenia was more effecive than standard outpatient treatment.   "
170797|NCT00073853|"     Autologous Incubated Macrophages (ProCord) is being developed as a therapy for acute,     complete spinal cord injury (SCI). The therapy is intended to reverse the loss of motor and     sensory function.      Following non-CNS tissue injury, macrophages quickly arrive on the scene, where they clean up     cell debris, secrete different molecules thus promoting a controlled inflammatory reaction     that forms the first phase of the wound healing process. While this process occurs in most     tissues, including peripheral nerves, it does not occur in the CNS, where macrophages and     other immune cells are relatively rare, and their activities curtailed by a biochemical     mechanism known as immune privilege.      In animal studies, it appears that incubated macrophages circumvent the immune privilege,     thus supporting the regrowth of axons through the injury site and enabling the recovery of     neurological function. The concept derives from the pioneering research of Prof. Michal     Schwartz at the Weizmann Institute of Science.   "
170800|NCT00073892|"     RATIONALE: PI-88 may stop the growth of cancer by stopping blood flow to the tumor.      PURPOSE: Phase I/II trial to study the effectiveness of PI-88 in treating patients who have     an advanced malignancy (cancer) or stage IV melanoma.   "
170801|NCT00073905|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, use different     ways to stop tumor cells from dividing so they stop growing or die. Palliative chemotherapy     may improve the quality of life in patients who have locally advanced or metastatic biliary     tract cancer and may help them live more comfortably.      PURPOSE: Phase II trial to study the effectiveness of adjuvant capecitabine and gemcitabine     in improving quality of life in patients who have locally advanced or metastatic biliary     tract cancer.   "
170802|NCT00073918|"     This phase II trial is studying how well giving iodine I 131 tositumomab together with     etoposide and cyclophosphamide followed by autologous stem cell transplant works in treating     patients with relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal     antibodies, such as iodine I 131 tositumomab, can find cancer cells and deliver radioactive     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy,     such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Combining a     radiolabeled monoclonal antibody with combination chemotherapy before autologous stem cell     transplant may kill more cancer cells   "
170803|NCT00073931|"     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can locate     cancer cells and deliver radioactive cancer-killing substances to them without harming normal     cells. Combining a radiolabeled monoclonal antibody with autologous stem cell transplantation     may be an effective treatment for non-Hodgkin's lymphoma.      PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with     autologous stem cell transplantation in treating older patients who have relapsed or     refractory non-Hodgkin's lymphoma.   "
170804|NCT00073944|"     RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for     their growth.      PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have     refractory cancer.   "
170805|NCT00073957|"     RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab,     can locate cancer cells and either kill them or deliver radioactive cancer-killing substances     to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with     rituximab may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab     tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large     B-cell non-Hodgkin's lymphoma.   "
170806|NCT00073970|"     RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by     blocking the enzymes necessary for tumor cell growth.      PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who have     relapsed prostate cancer following radiation therapy or radical prostatectomy.   "
170807|NCT00073983|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different     ways to stop tumor cells from dividing so they stop growing or die. Combining gemcitabine     with docetaxel may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in     treating patients who have recurrent osteosarcoma, recurrent Ewing's sarcoma, or unresectable     or locally recurrent chondrosarcoma.   "
170808|NCT00074009|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary     for their growth.      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who     have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.   "
170809|NCT00074022|"     Phase I/II trial to study the effectiveness of combining GTI-2040 with docetaxel in treating     patients who have recurrent, metastatic, or unresectable locally advanced non-small cell lung     cancer, prostate cancer, or other solid tumors. GTI-2040 may stop the growth of cancer cells     by blocking the enzymes necessary for their growth. It may also increase the effectiveness of     docetaxel by making the tumor cells more sensitive to the drug. Combining GTI-2040 with     docetaxel may kill more tumor cells   "
171017|NCT00076648|"     This study is designed to assess the survival benefit of administering PolyHeme to severely     injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where     blood is not available, and continuing throughout a 12-hour postinjury hospital setting.   "
170810|NCT00074035|"     RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by     stopping the immune system from rejecting donor stem cells or donor white blood cells.      PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with     chronic graft-versus-host disease that is refractory (not responsive) to treatment with     steroids.   "
170811|NCT00074048|"     RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal     cells. This may be an effective treatment for hairy cell leukemia that has not responded to     treatment with cladribine.      PURPOSE: This phase II trial is studying BL22 immunotoxin to see how well it works in     treating patients previously treated with cladribine for hairy cell leukemia.   "
170812|NCT00074074|"     RATIONALE: Monoclonal antibodies, such as infliximab, can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: Randomized phase II trial to study the effectiveness of infliximab in treating     patients who have myelodysplastic syndrome.   "
170813|NCT00074087|"     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, use different ways to     stop cancer cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating     patients who have stage IIB, stage IVA, or stage IVB recurrent or refractory mycosis     fungoides.   "
170814|NCT00074100|"     RATIONALE: Drugs used in chemotherapy, such as amonafide, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of amonafide in treating women who have     metastatic breast cancer that has progressed after previous chemotherapy.   "
170815|NCT00066807|"     The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women     with steroid hormone receptor positive early invasive breast cancer who receive ovarian     function suppression plus either tamoxifen or exemestane for five years. The use of     chemotherapy was determined by randomization. The method of ovarian function suppression     (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice     of tamoxifen or exemestane were determined by the investigator or by randomization in the     IBCSG 25-02 TEXT trial [recommended option]. The trial was terminated early due to poor     accrual.   "
170816|NCT00066846|"     RATIONALE: Bevacizumab may stop the growth of tumor cells by blocking the enzymes necessary     for cancer cell growth. Drugs used in chemotherapy such as fluorouracil and leucovorin use     different ways to stop tumor cells from dividing so they stop growing or die. Combining     bevacizumab with fluorouracil and leucovorin may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil     and leucovorin in treating patients who have locally advanced or metastatic stage IV     colorectal cancer that has progressed after standard chemotherapy.   "
170817|NCT00066859|"     RATIONALE: Antidepressants such as sertraline and the herb hypericum perforatum (St. John's     wort) may be effective in treating mild to moderate depression. It is not yet known which     treatment is more effective in improving depression in patients who have cancer.      PURPOSE: This randomized phase III trial is studying how well sertraline works compared to     St. John's wort in treating mild to moderate depression in patients with solid tumors.   "
170818|NCT00066872|"     RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune     system and stop cancer cells from growing. It is not yet known if topical imiquimod is more     effective than surgery in treating basal cell skin cancer.      PURPOSE: This randomized phase III trial is studying how well topical imiquimod works     compared to surgery in treating patients with basal cell skin cancer.   "
170819|NCT00066885|"     This Phase 1/2 clinical trial is a multi-center, open-label study with three main objectives.     The first (Phase 1A) is to determine the maximum-tolerated dose of DN-101 when administered     in combination with Taxotere (docetaxel) every three weeks (closed). The second is to     determine the maximum-tolerated dose of DN-101 when administered weekly in combination with     Taxotere(docetaxel)devery three weeks (open). The third is to evaluate the safety and     objective tumor response rate of the combination in NSCLC. DN-101 doses will be escalated at     three dosing levels. Patients will receive oral DN-101 on day one, followed by intravenous     docetaxel on day two of a 21-day cycle. Treatment cycles will be repeated at the same dose     level each 21 days until disease progression or unacceptable toxicity.   "
170820|NCT00066898|"     To assess the safety and efficacy of AGI-1067, as compared to placebo, in the treatment of     vascular inflammation and atherosclerosis by assessing the reduction in cardiovascular     events.   "
170821|NCT00066911|"     Some voice disorders are caused by uncontrolled muscle actions that affect the larynx or     voice box.      The purpose of this study is to understand 1) how the brain controls voice production; 2) how     changes in sensation within the voice box affect brain control of the voice box; 3) how the     central nervous system is affected when people have motor or sensory abnormalities that     affect the voice box; and 4) whether patients with voice disorders differ from people without     voice disorders in the way the brain controls the voice box. By better understanding these     concepts, researchers hope to develop improved treatments for patients with voice disorders.      Forty-five healthy adult volunteers and 90 patients with voice disorders will participate in     this study. Participants must be between the ages of 20 and 70. The study will involve two     visits to the Clinical Center. During the first visit, participants will undergo a medical     history and physical exam. During the second visit, investigators will perform the following     procedures on study participants: 1) look at the voice box with a nasolaryngoscope, a fine     tube through the nose; 2) use MRI [magnetic resonance imaging] to record brain activity while     participants use their voice to speak; 3) changing sensation in the voice box by dripping a     topical anesthetic onto the vocal folds; and 4) using MRI to again record brain activity     during speech immediately after applying the topical anesthetic.      Participants will receive up to $700 in compensation for their involvement in this study.   "
170822|NCT00066924|"     The purpose of this study is to determine whether religiosity and spirituality are related to     immune functioning, as measured by interleukin-6 blood plasma level, among terminally ill     cancer patients.   "
170823|NCT00066937|"     The purpose of this study is to determine whether the combination of cognitive-behavioral     treatment and nortriptyline are more effective than each treatment alone in reducing the pain     and disability associated with TMD.   "
171018|NCT00076674|"     This study will evaluate the effects of levetiracetam (Keppra (Trademark) on Parkinson's     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of     long-term treatment with levodopa. Levetiracetam blocks certain protein receptors on brain     cells and thus can change the spread of brain signals believed to be affected in patients     with Parkinson's disease.      Patients between 30 and 80 years of age with relatively advanced Parkinson's disease and     dyskinesias due to levodopa therapy may be eligible for this 6-week study.      Screening and baseline evaluation - Participants are evaluated with a medical history,     physical examination and neurologic evaluation, blood tests, urinalysis, electrocardiogram     (EKG), 24-hour holter monitor (heart monitoring), and cardiology consultation. A chest x-ray     and MRI or CT scan of the brain are done if needed. If possible, patients stop taking all     antiparkinsonian medications except levodopa (Sinemet) for one month (2 months if taking     Selegiline) before the study begins and throughout its duration. (If necessary, patients may     use short-acting agents, such as Mirapex, Requip or Amantadine.)      Dose-finding phase - Patients are admitted to the NIH Clinical Center for 2 to 3 days for a     levodopa dose-finding procedure. For this test, patients stop taking Sinemet and instead     have levodopa infused through a vein. During the infusions, the drug dose is increased slowly     until parkinsonian symptoms improve or unacceptable side effects occur or the maximum study     dose is reached. Symptoms are monitored frequently. (Patients who have had dosing infusions     in the last 3 months do not have to undergo this phase of the study.)      Active study phase - Patients are randomly assigned to take levetiracetam or placebo (sugar     pill) twice a day for 6 weeks. At the end of weeks 1, 2 4, and 5, patients come to the     clinic for blood tests, an EKG, and a review of adverse side effects. At the end of weeks 3     and 6, patients are hospitalized to study the response to treatment. They again stop taking     Sinemet and selegiline and their ability to perform motor tasks is evaluated. They are then     placed on an L-dopa infusion for 10 hours. Placebo may be infused at various times instead of     L-dopa. Motor symptoms are evaluated several times during the infusion. Blood is drawn once     during the infusion for research studies.      Lumbar puncture - Patients undergo a lumbar puncture (spinal tap) at the end of weeks 1 and 4     to measure certain brain chemicals and drug levels. For this test, a local anesthetic is     given and a needle is inserted in the space between the vertebrae in the lower back. About 2     tablespoons of fluid is collected through the needle.      Magnetic resonance imaging (MRI) - Patients with changing disease activity may undergo MRIs     at baseline, at the end of week 1 and at the end of the study to show changes in the brain.     The patient lies in a narrow cylinder (the scanner) that uses radio waves and a magnetic     field to produce images of the brain, which show structural and chemical changes.      Follow-up - 2 weeks after the study ends, patients are contacted by phone for a review of     side effects or they return to the clinic for an evaluation.   "
170824|NCT00066950|"     The purpose of this study is to determine whether dental disease patterns and transmissable     bacteria that are known to cause a severe form of dental decay in young children can be     reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine     and fluoride varnish applications, respectively as part of a comprehensive Prevention     Management Model.   "
170825|NCT00066963|"     The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or     twice a year with counseling to counseling alone in preventing early childhood caries (ECC)     (tooth decay in children under the age of five).   "
170826|NCT00066976|"     Some babies have difficulty breathing, sucking, and swallowing at birth. The purpose of this     study is to determine (before birth) the variables that will predict whether a newborn will     experience these problems.      Study participants will be pregnant women with a single fetus who are 18 years or older and     who are scheduled to receive a standard prenatal ultrasound. Researchers will use the     ultrasound to observe fetal motions associated with breathing, sucking, and swallowing on     digital videotape. They will then review these tapes and take measurements that will help     them document how breathing and swallowing develop.   "
170827|NCT00066989|"     The main objective will be to test the safety of two intravenous infusions of Altastaph, a     human immunoglobulin product. The study will also test the ability of Altastaph to protect     against S. aureus infection.   "
170828|NCT00067002|"     The goal of this clinical research study is to learn if combining cord blood units to make     the cells take faster in recipients will help to improve the results of cord blood     transplants.   "
170829|NCT00067015|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation     therapy in different ways may cause less damage to normal tissue and may improve quality of     life and help patients live more comfortably. Androgens can stimulate the growth of prostate     cancer cells. Drugs such as goserelin and bicalutamide may fight cancer by stopping the     production of androgens. It is not yet known whether radiation therapy is more effective with     or without goserelin and bicalutamide in treating prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation     therapy with or without bicalutamide and goserelin in treating patients who have prostate     cancer.   "
170830|NCT00067028|"     The goal of this clinical research study is to find the best safe dose for 2 different drug     combinations. For this purpose, participants will either receive the combination of     clofarabine plus idarubicin or clofarabine plus idarubicin and ara-C. Once the best safe dose     for these drug combinations are found, the next goal is to compare the drug combinations     clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment     of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic     Myeloid Leukemia who have relapsed following their initial therapy. In the current extension     part of the study, you will only receive the clofarabine/idarubicin/ara-C combination. The     activity and the safety of this treatment will be studied.   "
170831|NCT00067041|"     Approximately 30 patients will be enrolled in this 12-week study designed to assess the     effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass     grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted     in the hospital and on an out-patient basis. The study will be conducted at multiple centers.   "
170832|NCT00067054|"     This study collects specimens from volunteers for use in studies by NIAID's Vaccine Research     Center. A number of different types of specimens or samples can be collected, including     blood, urine, body fluids or secretions, skin swabs, or skin biopsies. The samples are used     for medical research, including the study of HIV, hepatitis, and other diseases; immune     system responses, such as responses to vaccinations or infections; and for research on     vaccine development.      Blood samples may be collected either by ordinary blood drawing (phlebotomy) or by apheresis,     a procedure for collecting a larger quantity of blood cells or plasma than would be possible     through simple blood drawing. For this procedure, the subject lies on a recliner or couch.     Blood is removed through a needle in the vein of one arm and spun in a machine that separates     out the desired component (plasma or white blood cells). The remainder of the blood is     returned either through the same needle or through a needle in the other arm. The procedure     takes about 1 to 3 hours.      Volunteers who are 18 years of age and older, including participants in other NIH research     protocols, may be eligible. Individuals who have a condition that the research staff     considers a reason not to make a sample donation will be excluded from the study.      Participants may have only one sample collected or may be asked to undergo repetitive sample     collection procedures, depending upon the requirements of the particular research project for     which the samples are being collected. Each individual's enrollment is for a 1-year period,     which can be extended.   "
170833|NCT00067067|"     Recent studies suggest that cells in the bone marrow-endothelial precursor cells (EPCs)-can     provide a blood supply to cancerous tumors.      The purpose of this study is to collect brain tumor and blood samples to look for these EPCs     in the samples and analyze the growth signals that may help blood vessels to grow in tumors.     Researchers will study the following in the samples: 1) the number of blood vessels in the     tumor; 2) the levels of growth factors in the tumor and blood; 3) the levels of circulating     EPCs in the blood; and 4) the changes in the genes and proteins in the blood and tumor that     influence growth factor levels.      Participants will be 18 years of age or older and have evidence of a brain tumor that     requires surgery. From this surgery they will donate blood and tumor samples. Participants     will have follow-up visits 4 to 8 weeks after surgery, then at 3-month intervals for     two-and-one-half years, then at 6-month intervals thereafter. At these visits, participants     will undergo a physical exam, a brain scan, and blood work.   "
170834|NCT00067080|"     The purpose of this study is to determine if the new orally active iron chelator, ICL670, is     as safe as deferoxamine in preventing accumulation of iron in the body while a patient is     undergoing repeated blood transfusions.   "
170885|NCT00074802|"     This study will examine whether the addition of cognitive behavioral therapy can improve the     efficacy of the medication paroxetine (Paxil®) in treating individuals with social anxiety     disorder. Patients with social anxiety disorder will undergo a 12-week open trial with     paroxetine. Those who complete the open trial having achieved only partial response will be     randomized to receive cognitive behavioral therapy (CBT) in addition to paroxetine or to     continue on paroxetine alone for an additional 16 weeks.   "
170835|NCT00067093|"     Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study.     The purpose of the study is to compare the safety and effectiveness of a new injectable     anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the     standard way of treating deep vein thrombosis. The standard treatment includes injections or     infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin)     for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or     acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with     either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight     heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to     both patients and their doctors.   "
170836|NCT00067106|"     HIV is found in both the blood and the genital tract. This study will compare the levels and     types of HIV found in the blood with the levels and types of HIV found in the female genital     tract.      Study hypotheses: 1) In the presence of antiretroviral therapy, viral replication within the     female genital tract may lead to the development of drug resistance that is different from     that of virus in the blood plasma. 2) Antiretroviral drug levels in the female genital tract     may often be lower than in the blood plasma and differences in drug exposure may be     associated with differences in virus replication and selection of resistant HIV variants     during drug failure. 3) HIV can be recovered in vitro from cells in the female genital tract     during successful therapy, and it may be genetically different from the HIV variants     recovered from the blood cell latent reservoir on the same visit.   "
170837|NCT00067119|"     Fistula Study: The objective of the study is to determine whether clopidogrel reduces the     early failure rate of native AV fistulae.      Graft Study: The objective of the study is to determine whether Aggrenox     (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous     grafts.   "
170848|NCT00067262|"     The purpose of this study is to determine the safety and effectiveness of Depakote ER     (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar     disorder, manic or mixed type in children and adolescents ages 10-17 years.   "
170849|NCT00067275|"     This study will examine how dopamine, a brain chemical, affects motor training. Taken by     mouth, dopamine can enhance motor training, especially during rehabilitation after brain     damage. The study will also examine whether Sinemet, a drug containing a precursor of     dopamine, can improve motor training.      Healthy normal volunteers and stroke patients between 18 and 80 years of age may be eligible     for this study. Healthy volunteers must be right-handed. Stroke patients must have had a     stroke that caused weakness in one hand, from which they have recovered enough to be able to     move the thumb in different directions. Participants will have up to three study sessions, as     follows:      Prestudy 1 (MRI, TMS with motor training)        -  Session 1: Magnetic resonance imaging (MRI) of the brain. This procedure uses a strong          magnetic field and radio waves to show structural and chemical changes in tissues.          During the scan, the patient lies on a table in a narrow cylinder containing a magnetic          field. He or she can communicate with the staff administering the test at all times.        -  Session 2: Transcranial magnetic stimulation (TMS) - The subject sits in a comfortable          chair with the right forearm held still at the side and the head held still by an          aluminum frame. A magnetic coil is placed over the head, and a small probe is attached          to the thumb to measure thumb movement. Magnetic pulses are occasionally delivered over          the scalp, likely inducing a mild thumb movement. After this test, the subject takes a          tablet of either Sinemet or placebo (a look-alike pill with no active ingredient). Fifty          minutes after taking the pill, the subject undergoes motor training that involves          performing brisk thumb movements at a rate of 1 movement per second. At the end of the          training, TMS is repeated.        -  Session 3: Identical to session 2, except subjects who took Sinemet in session 2 now          take placebo, and vice versa.      Prestudy 2 (MRI, PET without motor training, no TMS)        -  Session 1: MRI of the brain if the subject has not had one within the last 12 months.        -  Session 2: Positron emission tomography (PET) scanning - This procedure provides          information on brain chemistry and function. First, the subject is given either Sinemet          or placebo. The subject lies on a bed in a doughnut-shaped machine with a custom-molded          plastic mask placed over the face and head to support the head and hold it still during          the scanning. A catheter (plastic tube) is placed in each arm-one to inject          [11C]raclopride-a radioactive substance that competes with dopamine for binding in          certain parts of the brain and can be detected by the PET scanner-and one to draw blood          samples for measuring the level of Sinemet in the blood.        -  Session 3: Identical to session 2, except subjects who took Sinemet in session 2 now          take placebo, and vice versa.      Main Study (MRI, TMS, PET with motor training)        -  Session 1: MRI of the brain, if one has not been done within the last 12 months.        -  Session 2: TMS, followed by administration of Sinemet or placebo and PET scanning with          motor training. The subject lies quietly during the first half of the PET session and          performs brisk thumb movements during the second half. After completing the PET scan,          the subject undergoes TMS again.        -  Session 3: Identical to session 2, except subjects who took Sinemet in session 2 now          take placebo, and vice versa.   "
170838|NCT00067132|"     Of the four million trauma cases each year that will require hospitalization, 200,000 will be     classified as severe trauma. During the hospital stay, malnutrition is a major complication     in about 50% of the patient population. The result is muscle wasting which is a major risk     factor for increased morbidity and mortality. In this study we postulate that supplementation     with beta-hydroxy-beta-methylbutyrate (HMB), arginine and glutamine (HMB/Arg/Gln)or HMB alone     to these severely traumatized patients can stem the loss of muscle tissue and whole body     nitrogen and in turn decrease morbidity and mortality. This hypothesis is based on two recent     studies showing the same nutritional mixture of HMB/Arg/Gln can reverse the muscle wasting     associated with AIDS and Cancer. The hypermetabolic state seen in AIDS and cancer have a     similar multifactorial etiology as seen in trauma. There is an increase in the mobilization     of fat and muscle, increased or normal metabolic rate, increased protein breakdown, and an     increased or normal glucose turnover. In addition, HMB alone has been shown to reduce     nitrogen loss, decrease muscle proteolysis and muscle damage within the first 48 hours to     three weeks after initiating supplementation during a strenuous exercise program. Male and     female patients (n=100) will be recruited at the time of admittance to the Trauma ICU with an     ISS of greater than 18. Patients who meet the inclusion/exclusion criteria will be randomized     to receive either 1) standard tube feed plus HMB/Arg/Gln, 2) standard tube feed plus HMB     alone, or 3)standard tube feed (control) in a double-blinded fashion. Clinical outcomes     measures will be assessed through out the hospital stay and on an outpatient basis at weeks 4     and 12. Muscle proteolysis and nitrogen economy will be evaluated on daily basis while in the     hospital and after 4 weeks on an out patient basis. If as expected, Phase I results confirm     the effectiveness of the nutrient mixture in trauma patients, expanded multicenter studies     will be proposed in Phase II.   "
170839|NCT00067145|"     Many overweight patients are able to lose weight successfully, but then regain their weight.     The purpose of this study is to develop and test the efficacy of 2 interventions to prevent     weight regain in individuals who have recently lost weight. The two interventions being     tested are a face-to-face group maintenance program and an Internet intervention. These     interventions will be compared to a no-contact control group that receives quarterly     newsletters. The primary outcome measure is weight regain from baseline to 18-months.   "
170840|NCT00067158|"     The purpose of this study is to look at how feasible it is to incorporate a state-of-the-art     smoking cessation treatment program into community substance abuse treatment programs and its     impact on substance abuse and cigarette smoking.   "
170841|NCT00067171|"     The purpose of this study is to test a feasibility study of a telephone enhancement procedure     (TELE) to improve participation in continuing care activities.   "
170842|NCT00067184|"     The purpose of this study is to examine differences in fetal neurobehavior at peak (2 hours     after oral dose) vs. trough (2 hours before oral dose) maternal plasma methadone levels.   "
170843|NCT00067197|"     No universally successful therapy exists that promotes recovery of motor function after a     stroke, the main cause of long-term disability among adults.      The purpose of this study is to develop strategies to improve recovery of lost motor     function. It will combine motor skills training with a brain-stimulating technique called     transcranial direct current stimulation (tDCS).      Healthy adult volunteers and adult stroke patients will be enrolled in this study.     Participants will come to NIH for a clinical and neurological exam, and, if necessary, an MRI     [magnetic resonance imaging] examination. Participants will return for 4 sessions; each     lasting approximately 3 hours. The first will be a practice session during which participants     will become familiar with the motor skills required of them in this study, such as performing     finger movements on a keyboard, pinching, tapping, making wrist movements, and lifting small     items. In sessions 2 and 3, participants will perform the motor skills they practiced in     session 1 while receiving tDCS. During session 4, they will receive tDCS only, with no     performance of motor skills.      During tDCS, investigators will place electrodes with a gel on participants' heads and pass     the tDCS current between these two electrodes. tDCS is a painless procedure.      Participants will receive up to $420 in compensation for their involvement in this study.   "
170844|NCT00067210|"     Doctors use cooling of the brain to help stop seizures. This procedure is usually     accomplished through surgery. Cooling of the face and scalp may also cool the brain, avoiding     the need for surgery.      The purpose of this study is to assess a head-neck cooling device that the patient can wear.     Researchers will determine whether the device can change the frequency of seizures in people     with epilepsy.      Study participants must be 21 years of age or older and must experience seizures that occur     once a week on a regular basis. Participants will be asked to keep a detailed seizure diary     for a 12-week period before the date of the first cooling session. For each of the four     cooling sessions, participants will be admitted to the hospital overnight. They will undergo     a physical and neurological exam and an EEG (electroencephalogram). They will also swallow a     temperature-sensor pill. Participants will have one 60-minute cooling session once a week for     4 weeks. Investigators will paste temperature-sensing electrodes on the scalp, forearm,     abdomen, and leg. Participants will then be fitted with the cooling unit and the session will     begin.   "
170845|NCT00067223|"     Recent studies suggest that when patients learn a new motor movement, it may cause a change     in the way the nerves act in the area of the brain that controls that movement. This change     is called use-dependent plasticity.      The purpose of this study is to determine the direction and extent of the changes that take     place in the brain areas that control movement in the untrained finger after the training of     the opposite finger. The study outcomes may help researchers to develop rehabilitation     strategies for people who have suffered brain injuries.      Eighteen healthy adults age 18 years or older will be enrolled in this study. Participants     will undergo a clinical exam and then come back to the Clinical Center three times for     sessions that will last approximately 2 hours each. For each session, participants' forearms     will be immobilized and a small electronic device will be attached to each index finger so     that researchers can measure their movements. Participants will be asked to move either index     finger and to observe and concentrate on its movement. Investigators will perform     transcranial magnetic stimulation (TMS) before and after these motor exercises. For TMS, a     wire coil is held over the scalp and a brief electrical current passes through the coil,     creating a magnetic pulse that electrically stimulates the brain.   "
170846|NCT00067236|"     The main purpose of the study is to test whether a possible new drug (called PG-116800) can     prevent some of the damage to heart muscle in patients who have had a heart attack. The study     will also supply information regarding possible uses of this compound in cardiovascular     disease.   "
170847|NCT00067249|"     The purpose of this study is to examine socio-cultural factors of women’s use of     complementary and alternative medicine (CAM). The effects of socioeconomic status, social     networks and acculturation on CAM use will be assessed among white, African-, Mexican-, and     Chinese-American women.   "
170850|NCT00067288|"     We have developed an 8-week Meaning-Centered Group Psychotherapy designed to help patients     with advanced cancer sustain or enhance a sense of meaning, peace and purpose despite the     limitations of their cancer illness. This project's overall aim is to explore the feasibility     and efficacy of this new and unique psychotherapy intervention for advanced cancer patients     in enhancing psychological and spiritual well-being and quality of life by comparing it with     a standard supportive group psychotherapy.   "
170851|NCT00067301|"     The purpose of this study is to determine if omega-3 fatty acid EPA will enhance and speed up     response to antidepressant therapy with Celexa (Citalopram) in people suffering from Major     Depressive Disorder. All patients will receive Celexa, 50% will receive EPA, 50% placebo EPA.   "
170852|NCT00067314|"     This international study will study how metastatic breast cancer responds to the     investigational drug treatment, what are the side effects of the investigational drug when     given to women with metastatic breast cancer and how often do these side effects occur. The     study will also analyze how fast investigational drug and its breakdown products are cleared     from the blood in these patients.   "
170853|NCT00067327|"     The purpose of this study is to determine whether raising low levels of the natural     antioxidant uric acid by the administration of a precursor, inosine, has any therapeutic     effect on the progression of Relapsing Remitting Multiple Sclerosis (RRMS) and secondary     progressive Multiple Sclerosis (MS).   "
170854|NCT00067340|"     The purpose of this study is to conduct a community based, randomized control trial to     determine if the use of chlorhexidine mouth rinse and xylitol-sweetened chewing gum will     reduce the vertical transmission of caries between Alaska Native mothers to their infants.   "
170855|NCT00067353|"     The aim of this study is to determine whether an annual application of three (3) fluoride     varnish doses over two weeks is at least as effective in reducing cavities as the current     semi-annual application.   "
170856|NCT00074139|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and cyclophosphamide,     use different ways to stop tumor cells from dividing so they stop growing or die. Combining     more than one drug and giving them at different times, may kill more tumor cells. It is not     yet known which combination chemotherapy regimen is more effective for breast cancer.      PURPOSE: Randomized phase I trial to compare the effectiveness of two regimens of docetaxel     combined with doxorubicin and cyclophosphamide in treating women who have advanced breast     cancer.   "
170857|NCT00074152|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. It is not yet known whether chemotherapy is effective in treating     women who have undergone surgery and radiation therapy for relapsed breast cancer.      PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy     in treating women who have undergone resection for local and/or regional relapsed breast     cancer.   "
170858|NCT00074165|"     RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and     cytarabine, use different ways to stop cancer cells from dividing so they stop growing or     die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels     around the brain and allow anticancer substances to be delivered directly to the brain tumor.     Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side     effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with     osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination     chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in     treating patients who have refractory or recurrent primary CNS lymphoma.   "
170886|NCT00074815|"     This study will determine whether cognitive behavioral therapy delivered by either     psychologists or psychiatrists can improve the effectiveness of serotonin reuptake inhibitor     treatment in children with obsessive compulsive disorder.   "
171019|NCT00076687|"     The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A     in patients with reduced lung function and focal upper limb poststroke spasticity   "
170859|NCT00074178|"     RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, etoposide     phosphate, dexamethasone, and cytarabine, work in different ways to stop cancer cells from     dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain     drugs to open the blood vessels around the brain and allow anticancer substances to be     delivered directly to the brain. Giving methotrexate, cyclophosphamide, and etoposide     phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine may     kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of giving methotrexate, cyclophosphamide,     and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and     cytarabine in treating patients who have primary CNS lymphoma.   "
170860|NCT00074191|"     RATIONALE: Drugs used in chemotherapy, such as methotrexate, procarbazine, lomustine,     dexamethasone, and cytarabine, use different ways to stop cancer cells from dividing so they     stop growing or die. Combining more than one drug may kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating     patients who have primary CNS lymphoma.   "
170861|NCT00074204|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and docetaxel, use     different ways to stop tumor cells from dividing so they stop growing or die. Combining more     than one drug may kill more tumor cells. It is not yet known which treatment regimen is more     effective for stage IIIB or stage IV non-small cell lung cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine and     carboplatin followed immediately by docetaxel with that of giving delayed docetaxel in     treating patients who have stage IIIB or stage IV non-small cell lung cancer.   "
170862|NCT00074230|"     RATIONALE: Vaccines made from a person's dendritic cells and antigens may make the body build     an immune response to kill tumor cells.      PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy using autologous     dendritic cells with antigens in treating patients who have stage IV cutaneous melanoma.   "
172943|NCT00105508|"     The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is     effective in the treatment of dyskinesia associated with dopaminergic treatment of     Parkinson's disease (PD).   "
170864|NCT00074269|"     RATIONALE: Giving chemotherapy, such as fludarabine and melphalan, before a donor peripheral     blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's     immune system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune system and help destroy any remaining tumor cells (graft-versus-tumor     effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the     transplant may help increase this effect. Sometimes the transplanted cells from a donor can     also make an immune response against the body's normal cells. Giving antithymocyte globulin,     cyclosporine, and methotrexate before or after the transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well antithymocyte globulin, high-dose     melphalan, fludarabine, and allogeneic peripheral stem cell transplant work in treating     patients with metastatic adenocarcinoma of the breast.   "
170865|NCT00074282|"     RATIONALE: Drugs used in chemotherapy, such as pentostatin, cyclophosphamide, and     lenalidomide work in different ways to stop cancer cells from dividing so they stop growing     or die. Monoclonal antibodies, such as rituximab can locate cancer cells and either kill them     or deliver cancer-killing substances to them without harming normal cells. Combining     chemotherapy with monoclonal antibody therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well pentostatin, cyclophosphamide, rituximab,     and lenalidomide work in treating patients with relapsed or refractory B-cell chronic     lymphocytic leukemia.   "
170866|NCT00074295|"     RATIONALE: Vaccines made from a person's tumor tissue may make the body build an immune     response to kill tumor cells.      PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating     patients with stage IIIB or stage IV bronchoalveolar (lung) cancer.   "
170867|NCT00074308|"     Phase II trial to study the effectiveness of combining imatinib mesylate with bevacizumab in     treating patients who have advanced melanoma or other metastatic or unresectable cancer.     Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the     tumor. Combining imatinib mesylate with bevacizumab may kill more tumor cells   "
170868|NCT00074321|"     Drugs used in chemotherapy, such as irinotecan, oxaliplatin, and capecitabine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Combining more     than one chemotherapy drug may kill more tumor cells. This phase I trial is studying the side     effects and best dose of irinotecan, oxaliplatin, and capecitabine in treating patients with     unresectable solid tumors.   "
170869|NCT00074334|"     RATIONALE: The TP-38 toxin can locate tumor cells and kill them without harming normal cells.     Giving TP-38 toxin directly into the tumor may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of TP-38 toxin     administered directly into the brain and to see how well it works in treating young patients     with recurrent or progressive supratentorial high-grade glioma.   "
170887|NCT00074828|"     LY517717 (a capsule given by mouth) is a blood thinner that may prevent blood clots from     forming in the legs and may prevent those blood clots from traveling to the lungs. Leg and     lung blood clots occur commonly after patients have surgery to replace a hip or knee joint.     These clots often occur while patients are in bed in the hospital after hip or knee joint     surgery. The purpose of this study is to test if different dose strengths (amount of drug in     the capsules) of LY517717 can prevent blood clots from forming and to determine if LY517717     is safe. This study will compare LY517717 to enoxaparin, another blood thinner. Enoxaparin is     one of the standard medications given after hip or knee joint surgery.   "
170888|NCT00074841|"     This primary objective of this study is to assess whether the combination of Azithromycin     with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus     chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum     in adults in India.   "
170889|NCT00074854|"     The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase     inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is     effective in the treatment of advanced stage non-small cell lung cancer.   "
170870|NCT00074360|"     This study is divided into two parts; each designed to answer a separate but related     question:      Which brain regions are activated in humans by the rewarding properties of ethanol     administration?      Is it possible to demonstrate a conditioned response to a stimulus paired with rising blood     alcohol concentrations (BAC) in humans and can this response be observed in the brain using     functional magnetic resonance images (fMRI) techniques?      Part 1. In order to determine which brain regions are activated by the rewarding properties     of ethanol administration, we propose to use Blood Oxygenation Level Dependent (BOLD) fMRI     techniques to test the hypothesis that during the time of rising and peak BAC, mesolimbic,     mesocortical, and nigrostriatal dopamine (DA) terminal areas of the brain will show     significant increases in cerebral blood flow. Healthy, non-alcoholic subjects will be given     intravenous (IV) ethanol or placebo infusions on separate days. The infusions will have three     phases. On each day, during the first phase a saline infusion will be used to measure basal     brain blood flow. The second phase will be an ethanol infusion delivered at rates calculated     to produce a BAC of 0.08 plus or minus 0.005 g/dl at 10 minutes. The rate of the infusion for     the next 10 minutes (third phase) will be calculated to maintain BAC at the target level of     0.08 plus or minus 0.005 g/dl for the duration of the infusion. On the placebo day, subjects     will receive a saline infusion at the same set of rates for phases two and three as used     during their ethanol infusion. Continuous multi-slice fMRI data will be collected during each     infusion.      Part 2. In order to investigate conditioned response to ethanol, three groups of healthy,     non-alcoholic subjects will be given a series of IV infusions on separate days. The     experimental group will receive ethanol infusion paired with a conditioned stimulus (CS)     which will be presented while the BAC is rising. One control group (I) of healthy,     non-alcoholic subjects will also be given a series of intravenous ethanol infusions on     separate days, but these infusions will not be paired with a CS. The other control group (II)     will be given only saline infusions during the CS presentation. After three training     sessions, all three groups will undergo an fMRI scan during which the CS will be paired with     saline infusion. This will allow the response to the CS alone to be observed. After 10     minutes of CS presentation, the ethanol infusion will begin and continue for another 15     minutes. Conditioned response (CR) will be demonstrated if the experimental group shows     greater increase in BOLD signal than the control groups in motivation areas such as     mesolimbic, mesocortical, and nigrostriatal dopamine (DA) terminal areas of the brain in     response to the CS while they receive the saline infusion. Control group II will also undergo     an fMRI scan and will be given saline infusion followed by ethanol infusion during their last     15 minutes in the scanner to control for the non-specific effects of repeated infusions &     scans on BOLD response to ethanol. If we are able to produce a CR in brain regions associated     with motivation, it may be possible to use this CR as an experimental model for human alcohol     craving.   "
170871|NCT00074373|"     Women with lupus and other related disorders produce certain antibodies in the blood. Some     women have these antibodies even if they have not yet developed symptoms of lupus or     Sjogren's syndrome. When these women become pregnant, they may pass the antibodies to their     infants. The infants may then develop a disease called neonatal lupus. The symptoms of     neonatal lupus include an abnormally slow heart beat (heart block) and a skin rash. This     registry collects information on women and infants affected by neonatal lupus as well as     other family members who may be healthy.   "
170872|NCT00074386|"     With improved anti-HIV drug therapy, HIV infected patients are now living longer. These     patients are at risk for liver and kidney failure and may need organ transplants. However,     little is know about the safety and effectiveness of organ transplants in patients with HIV.     This study will evaluate organ transplantation in HIV infected patients undergoing liver and     kidney transplants.   "
170873|NCT00074399|"     HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The     purpose of this study is to determine whether giving infants of HIV infected mothers the     anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission.      Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease     HIV transmission through breastfeeding.   "
170874|NCT00074412|"     The many benefits of breastfeeding are well documented. However, because of the risk of     mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there     is considerable concern over the practice, especially in developing countries. The purpose of     this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP)     in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South     Africa, Tanzania, Uganda, and Zimbabwe.   "
170875|NCT00074425|"     The majority of HIV infected people worldwide became infected with the virus through     heterosexual contact. BufferGel and PRO 2000 Gel are vaginal gels designed to prevent women     from becoming infected with HIV during sexual intercourse with an HIV infected partner. This     study will test the safety and effectiveness of these gels.   "
170876|NCT00074438|"     This study will assess the efficacy and safety of different treatment regimens of rituximab     (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in     patients with active rheumatoid arthritis (RA).   "
170877|NCT00074451|"     To identify the genes involved in the metabolic syndrome.   "
170878|NCT00074464|"     To investigate the predictive value of using measures of cholesterol homeostasis to identify     individuals at high risk of developing cardiovascular disease relative to established risk     factors.   "
170879|NCT00074477|"     The purpose of this study is to determine the efficacy (how well the drug works), safety, and     side effects of paliperidone palmitate injection compared to placebo in the treatment of the     symptoms of schizophrenia in adults. The placebo used in this study was a nutritional     substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.   "
170880|NCT00074490|"     Background:      Patients with cancers of the blood and immune system often benefit from transplants of stem     cells from a genetically well-matched sibling. However, severe problems may follow these     transplants because of the high-dose chemotherapy and radiation that accompany the procedure.     Also, donated immune cells sometimes attack healthy tissues in a reaction called     graft-versus-host disease (GVHD), damaging organs such as the liver, intestines and skin. To     reduce toxicity of high-dose preparative chemotherapy, this study performs allogeneic     transplant after low doses of chemotherapy. In an attempt to improve anti-tumor effects     without increasing GVHD, this study uses donor immune cells (Th2 cells) grown in the     laboratory; some patients will receive standard donor immune cells (not grown in laboratory).     All patients will receive immune modulating drugs sirolimus and cyclosporine to prevent GVHD.      Objective:      To determine the safety, treatment effects and rate of GVHD in patients receiving transplants     that use low-intensity chemotherapy, sirolimus plus cyclosporine, and transplant booster with     either Th2 cells or standard immune cells.      Eligibility:      Patients 16 to 75 years of age with acute or chronic leukemia, non-Hodgkin's lymphoma,     Hodgkin's disease, multiple myeloma, or myelodysplastic syndrome.      Patients must have a suitable genetically matched sibling donor and adequate kidney, heart     and lung function.      Design: The protocol has three treatment groups: cohort 1, Th2 booster at two weeks     post-transplant; cohort 2, standard T cell booster at two weeks post-transplant; cohort 3,     multiple infusion of Th2 cells.      Condition<TAB>Hematologic Neoplasms, Myeloproliferative Disorders      Intervention<TAB>Biological; therapeutic allogeneic lymphocytes      <TAB><TAB>Drug: Sirolimus      Study Type:<TAB> Interventional      Study Design:<TAB>Primary Purpose: Treatment      Phase:<TAB><TAB>Phase II   "
170881|NCT00074503|"     This study will examine the use of positron emission tomography (PET) for measuring     docosahexaenoic acid (DHA) absorption from the blood into the brain. DHA is a type of fatty     acid found in fish and other seafood. It is involved in brain cell activity that underlies     the ability to think, move, and respond to the outside world. When the amount of DHA in the     brain is low, the brain may not work the same as if there were a normal amount of DHA. If PET     can be used successfully to evaluate brain DHA metabolism, this method might be useful for     future studies of alcoholism, since brain DHA levels are influenced by alcohol consumption.      Healthy normal volunteers between 18 and 65 years of age may be eligible for this study.     Because study participants must stop taking any medications, including herbal preparations,     individuals who require regular medication are excluded from this protocol. Participants will     undergo the following tests and procedures:        -  Psychological questionnaires concerning thoughts and behaviors.        -  Nutritional status analysis: A dietitian will assess the subject's nutritional status          through questionnaires and measurement of body fat. Body fat is measured using          bioelectrical impedance analysis. This analysis uses a low, safe electric current to          measure body composition, giving a reading of the percentage of fat in the body.        -  Fat biopsy to measure the composition of fat tissue: An area on the upper half of the          buttock will be numbed and a needle will be inserted to aspirate a sample of fat tissue          for analysis.        -  Blood drawing: Blood samples will be collected at the time of the fat biopsy and the PET          scan (see below) to measure DHA and indicators that may influence DHA.        -  Diet: 3 days before the fat biopsy and at least 3 days before the PET scan, subjects          will consume a diet low in DHA and other omega-3 fats. This no seafood diet prohibits          eating fish, shellfish, seaweed, seafood, health food products or supplemental vitamins,          and foods containing canola or flaxseed oil. Caffeine-containing beverages are limited          to one per day for 3 days before the study. Alcoholic beverages are prohibited for 2          weeks before the study. For 24 hours before the PET scan, subjects eat only standard          meals that will be provided to them.        -  Magnetic resonance imaging: A brain MRI scan will be done to fit the PET scan images          onto a picture of the whole brain. During the scan, the subject lies on a table inside a          narrow metal cylinder containing a strong magnetic field.        -  PET scan: Before the PET scan, catheters (small plastic tubes) are inserted into an arm          vein and into a wrist artery. The venous catheter is used for injecting a radioactive          substance that will be detected by the scanner, and the arterial catheter is used for          collecting blood samples during the scan. For the scan, the subject lies on a bed that          slides into the doughnut-shaped scanner. A mask is placed to keep the head still. A          transmission scan is done to see how much radiation the skull absorbs. Radioactive water          (15O-water) is then injected into the blood, and the brain is scanned for about 10          minutes to measure brain blood flow. Then, radioactive DHA (11C-DHA) is injected,          followed by about 1-1/2 hours of scanning to measure DHA absorption into the brain.   "
170882|NCT00074763|"     Objectives:        -  Determine the corrected count increment of autologous transfused platelets that had been          stored by cryopreservation with ThromboSol.        -  Determine the ability of autologous platelets that had been stored by cryopreservation          with ThromboSol to correct thrombocytopenia.   "
170883|NCT00074776|"     This study will compare the medications lithium and lamotrigine (Lamictal®) in treating     depression in individuals with bipolar II disorder.   "
170884|NCT00074789|"     This study will test the effectiveness of a short-term intervention in treating depressed     young mothers with young children enrolled in Early Head Start Programs.   "
179479|NCT00184522|"     A comparison of the effect of on demand treatment with a pectin-containing natural product     (Aflurax) with that esomeprazole (Nexium)   "
170890|NCT00074867|"     The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase     inhibitor is effective in the treatment of epithelial ovarian cancer, primary peritoneal     serous cancer, or fallopian tube cancer for patients who have failed first line     platinum-based therapy and have a persistent rising CA-125.   "
170891|NCT00074880|"     This study will examine how heart stiffness and a weak atrium affect exercise capacity and     symptoms in patients with hypertrophic cardiomyopathy (HCM). The atrium is the booster     pumping chamber of the heart that helps the ventricle (main pumping chamber), to fill     properly. HCM is an inherited disease in which the ventricle becomes thickened and, in some     patients, stiff. The stiffness makes it difficult for the ventricle to fill and empty,     causing breathing difficulty, fatigue, and reduced exercise capacity. Scar formation and a     weakened atrium can cause the heart to stiffen. Information gained from this study may guide     doctors in prescribing medicines to reduce scarring or improve atrial function.      Patients 21 years of age and older with hypertrophic cardiomyopathy may be eligible for this     study. Candidates will be screened with a medical history and physical examination,     electrocardiogram (EKG), blood tests, Holter monitor, and echocardiogram. A Holter monitor is     a device about the size of a Walkman that is connected to three wires that are attached to     the chest. It is worn for 24 hours to provide continuous monitoring of heart rhythm. An     echocardiogram uses a small probe that emits sound waves to produce images of the heart. The     probe is moved across the chest and the reflection of the sound waves from the chambers of     the heart produce images showing the heart's thickness and function.      Participants will undergo the following tests and procedures over 3 days:        -  Physical examination and echocardiogram.        -  Intravenous cannula insertion: A plastic tube is inserted into an arm vein for          collecting blood samples to measure substances that the heart and circulatory system          release at rest and during exercise.        -  Impedance cardiography: A small current of electricity is passed across the chest and          electrodes similar to those used for an EKG test are placed to measure blood flow in the          area of the current.        -  Pulmonary artery catheterization: A catheter (plastic tube) is inserted into a vein          either in the arm, under the collarbone, or in the neck and advanced to the right atrium          and ventricle. The catheter remains in place during the echocardiogram tilt and bicycle          exercise tests (see below).        -  Echocardiogram tilt test: The patient lies flat on a table. After a few minutes, the          table is tilted so that the patient's head is just above his or her feet for a short          while, then is positioned flat again, and then tilted so the feet are just above the          head. Echocardiographic measurements and blood samples are taken at intervals to examine          heart function during changes in posture.        -  Echocardiogram bicycle stress test: The patient exercises for as long as possible on a          bicycle-like machine while lying on his or her back. Echocardiographic measurements and          blood samples are taken at intervals during the test.        -  Treadmill stress test: The patient runs for as long as possible on a treadmill that          increases in difficulty. The patient wears a facemask or mouthpiece through which small          amounts of gases are added in order to measure the ability of the heart and lung to          increase their effectiveness with exercise.        -  Digoxin loading: Only patients who demonstrate limited exercise capacity and for whom          digoxin is not a risk will undergo this procedure. A medicine that makes the heart          contract more strongly, digoxin is used to treat certain heart abnormalities. Patients          are given doses of either digoxin or placebo (a look-alike injection with no active          ingredient) at 4-hour intervals over a 24-hour period and then repeat the tilt test and          the bicycle and treadmill exercise tests   "
170892|NCT00074893|"     When people use hand-held power tools, their hands and arms vibrate along with the tool they     are holding. People who frequently use hand-held power tools may develop injuries related to     this vibration. This study will evaluate a protective brace designed to prevent     vibration-related hand and arms injuries.   "
170893|NCT00074906|"     Study to demonstrate that administration of Venticute increases survival of patients with     pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation,     and severe oxygenation impairment.   "
170894|NCT00074919|"     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the     body's cells to break down glycogen (a stored form of sugar) within specialized structures     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates     and is stored in various tissues, especially heart and skeletal muscle, which prevents their     normal function. The objective of this protocol is to provide enzyme replacement therapy with     rhGAA on an expanded access basis, to severely affected patients with infantile-onset Pompe     disease for whom there is no alternative treatment and who do not meet the clinical     characteristics described in the inclusion criteria for participation in other Genzyme     Corporation-sponsored study currently enrolling patients with infantile-onset Pompe disease.   "
170913|NCT00075179|"     The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is     effective in lowering the pressure in your lungs.      The primary objective of this study is to establish that Nesiritide (Natrecor) is effective     in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean     pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in     pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of     toxicity, and surgeon's willingness to proceed with operation.   "
170895|NCT00074932|"     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the     body's cells to break down glycogen (a stored form of sugar) within specialized structures     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates     and is stored in various tissues, especially heart and skeletal muscle, which prevents their     normal function. The objective of this protocol is to provide enzyme replacement therapy with     alglucosidase alfa on an expanded access basis, to severely affected patients with late-onset     Pompe disease for whom there is no alternative treatment and who do not meet the clinical     characteristics described in the inclusion criteria for participation in other Genzyme     Corporation-sponsored studies currently enrolling patients with late-onset Pompe disease.   "
170896|NCT00074945|"     This study will explore factors that affect obesity and obesity-related diseases in both     Caucasians and African Americans. By looking at the rate at which the human body burns     calories while at rest (resting energy expenditure, or REE) and at the rate at which fat     travels through the blood (fatty acid flux), this study will examine the relationship between     REE and fatty acid flux, both of which are determinants of obesity. Researchers will compare     the test results of Caucasians and African Americans to determine if race has an effect on     the relationship between REE and fatty acid flux.      Volunteers must be between 18 and 49 years of age. Equal numbers of typical weight,     overweight, and obese participants will be recruited. Candidates will be screened with a     physical examination, electrocardiogram, and blood tests, and will be interviewed about diet     and exercise habits, family and medical history, and employment.      Participants will be placed on a two-week maintenance diet (prepared by a dietician to     regulate and maintain calorie consumption) and must visit an outpatient clinic for weight     measurement for 10 consecutive weekdays. During the two-week diet, participants will also     undergo two 20-minute computerized scans to measure abdominal and body fat. At the end of the     two weeks, participants will then be hospitalized for two days to allow researchers to     conduct blood tests, oral glucose tests, and a physical examination to measure REE and fatty     acid flux levels for comparison.   "
170897|NCT00074958|"     People with Fabry disease have an alteration in their genetic material (DNA) which causes a     deficiency of the a-galactosidase A enzyme. This enzyme helps to break down and remove     certain types of fatty substances called glycolipids. These glycolipids are normally     present within the body in most cells. In people with Fabry disease, glycolipids build up in     various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A     is not present, or is present in small quantities. The build up of glycolipid levels (also     referred to as globotriaosylceramide or GL-3) in these tissues is thought to cause the     clinical symptoms that are common to Fabry disease. Symptoms commonly appear during childhood     with pain in the hands and feet. This study explored the safety, efficacy and     pharmacokinetics of Fabrazyme in pediatric patients aged between 7 and 15 years.   "
170898|NCT00074971|"     People with Fabry disease have an alteration in their genetic material (DNA) which causes a     deficiency of the a-galactosidase A enzyme. Fabrazyme is a drug that helps to breakdown and     remove certain types of fatty substances called glycolipids. These glycolipids are normally     present within the body in most cells. In Fabry disease, glycolipids build up in various     tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not     present, or is present in small quantities. The build up of glycolipid     (globatriaosylceramide or GL-3) levels in these tissues in particular is thought to cause     the clinical symptoms that are common to Fabry disease. This study will test the safety and     efficacy of Fabrazyme in the treatment of patients with Fabry disease.   "
170899|NCT00074984|"     People with Fabry disease have an alteration in their genetic material (DNA) which causes a     deficiency of the a-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps     to breakdown and remove certain types of fatty substances called glycolipids. These     glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids     build up in various tissues such as the liver, kidney, skin, and blood vessels because     a-galactosidase A is not present, or is present in small quantities. The build up of     glycolipid (globotriaosylceramide or GL-3) levels in these tissues in particular is     thought to cause the clinical symptoms that are common to Fabry disease. This study will test     the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease.   "
170900|NCT00074997|"     The purpose of this study is to determine the safety and efficacy of administration of a     cell-delivered ribozyme gene transfer product to participants with chronic (lasting a long     time) Human Immunodeficiency Virus Type 1 (HIV-1) infection (a life-threatening infection     which you can get from an infected person's blood or from having sex with an infected     person).   "
170902|NCT00075023|"     This study was designed to be conducted in 2 parts. The first part is a pilot study to test     the effects of topical thalidomide gel 20mg applied to up to 3 oral ulcers in patients who     have developed oral chronic graft-versus-host-disease (cGVHD)-related ulcerative stomatitis     following allogeneic bone marrow/peripheral blood stem cell transplant (HSCT). Chronic GVHD     may be related to increased levels of a cytokine called TNF-alpha (TNFa) following HSCT.     Thalidomide's anti-inflammatory effects may lower TNFa levels, lead to healing of these oral     ulcers, and decrease oral pain.      If the pilot study is successful, the second part of the study will be done. This will test     the effects of a 0.1% (20mg) thalidomide mouthwash in treating oral cGVHD-related stomatitis     in patients following allogeneic HSCT. Applying thalidomide directly to the GVHD-related     mouth ulcer in gel form or to the entire oral cavity in mouthwash form rather than taking it     in pill form may reduce the amount of drug that enters the blood stream and cause less side     effects.      In the pilot study, participants will be randomly assigned to receive thalidomide gel 20mg or     placebo (identical gel with no thalidomide) to use 4 times a day for 4 weeks. In the     mouthwash study, participants will be randomly assigned to receive 0.1% 20mg thalidomide     mouthwash or placebo (identical mouth rinse with no thalidomide) to use 4 times a day for 4     weeks. Participants will undergo the following procedures before beginning experimental     treatment, then once a week for 4 weeks, and then approximately 8 weeks after the first     visit:        -  Interview about current medications and use of alcohol and cigarettes        -  Self-report of mouth and throat pain        -  Oral examination for stomatitis rating, and oral ulcer(s) measurement        -  Quality of life questionnaire (repeated only at week 8 of the study)        -  Mouth photography to measure and record the oral ulcer response to treatment        -  Saliva sampling to look for proinflammatory cytokines (small proteins), including TNFa        -  Oral ulcer exudate collected by filter paper to obtain fluid for measuring TNFa levels        -  Gentle swabbing of oral ulcers to culture for virus, fungus, and bacteria that may be          present        -  Small punch biopsy of the area near the ulcer or affected area to check for presence of          TNFa (repeated only at week 4 of the study)        -  Blood sampling to monitor TNFa levels        -  A urine pregnancy test for women who are able to have children (repeated at weeks 2, 4,          and 8)   "
170988|NCT00076258|"     This study will assess the effectiveness of an exercise program in improving antidepressant     medication treatment for individuals with major depressive disorder (MDD).   "
182772|NCT00235079|"     The purpose of the study is to determine whether colchicine is safe and effective in     treatment and prevention of recurrent pericarditis after failure of conventional treatment.   "
170903|NCT00075036|"     This study will examine communication and trust between patients in the kidney transplant     process and their health care providers. It will assess patients' perception of trust in     their physician and nurse coordinator; determine the patients' level of trust in the areas of     competence, compassion, control, communication, and confidentiality; and determine how the     trust level varies as patients progress in the transplant process.      Patients 18 years of age and older who are in various stages of the kidney transplant process     at Walter Reed Army Medical Center and the NIH Clinical Center may be eligible for this     study. Candidates include individuals who:        -  are on dialysis but not on a transplant waiting list        -  are on the organ waiting list and are also on dialysis        -  are on the organ waiting list but are not on dialysis        -  have had a kidney transplant within the last year.      Participants will be interviewed by someone who is not their direct health care provider     about the doctor/patient, primary provider/patient, or nurse/patient relationship, their     health history, medical condition, and ideas about their care. With the patient's permission,     parts of the interview will be tape-recorded. The interview will take about 30 to 40 minutes.   "
170904|NCT00075049|"     This is a double blinded study where 2 test vaccines will be evaluated to see if they protect     persons who have never had malaria against malaria infection when bitten by mosquitoes.   "
170905|NCT00075062|"     Microbicides are drugs that destroy microbes such as viruses and bacteria. Rectal     microbicides may be able to prevent transmission of HIV during anal intercourse. The purpose     of this study is to obtain rectal samples from men to learn information that may be valuable     in future clinical trials of rectal microbicides.   "
170906|NCT00075075|"     This small, preliminary study will examine whether multiple infusions of infliximab     (Remicade® (Registered Trademark)) can control inflammation in patients with active     scleritis. The sclera is the tough white outer coat enclosing the eyeball. Infliximab is a     combination of part human and part mouse proteins that block a natural body protein called     tumor necrosis factor (TNF). TNF appears to be involved in scleritis, and stopping its action     may help reduce the inflammation in the disease. The drug has been approved by the Food and     Drug Administration for treating Crohn's disease and rheumatoid arthritis.      Patients 18 years of age or older with active non-infectious scleritis may be eligible for     this study. Participants will undergo the following tests and procedures:        -  Medical history and physical examination.        -  Eye examination, including a vision test and examination of the retina (back part of the          eye) and of the sclera and its blood vessels.        -  Questionnaire about vision and daily activities.        -  Tuberculin skin test.        -  Pregnancy test: Women who can have children are tested for pregnancy at study weeks 0,          14, 30, 38, and 46.        -  Infliximab treatment: Infliximab is infused over a 2-hour period through a needle in a          vein, usually in the arm. The patient's vital signs are checked before the patient          begins each infusion starts and again before leaving the clinic. After the first two          infusions, if the disease remains quiet, other scleritis medications will be attempted          to be reduced to half the original dose over 8 to 12 weeks and possibly to nothing if          the patient continues to do well. Patients receive a maximum of 9 infusions over a          30-week period.        -  Blood draws: About 4 tablespoons of blood are drawn at each visit to test for the number          and types of cells in the blood and to check for signs of inflammation and side effects          of the study medicine.      Patients are seen in the NEI clinic for infusions and to check the response to therapy. This     includes 13 clinic visits over 46 weeks, as follows: every 2 weeks for the first 2 weeks,     every 4 weeks thereafter for a total of 30 weeks for infusions, and then every 4 weeks for 16     additional weeks.      Patients may stop therapy if their scleritis is not controlled 10 weeks into the study     period; if they develop a flare of inflammation after initial control of the active     scleritis; if their vision loss is too large; or if their medications increase or other     medicines are added to control the scleritis. Patients whose vision decreases minimally,     stays the same, or improves may remain in the study.   "
170907|NCT00075088|"     The purpose of this study is to see whether individuals who access the 911 emergency     medical system with a heart attack or severe chest pain will receive more timely hospital     treatment and better outcomes if hospital clinicians are provided with earlier and more     complete electrocardiography (ECG) information.   "
170908|NCT00075101|"     The purpose of this study is to determine the relationship between dexamethosone (steroid)     and children's sleep and fatigue.   "
170909|NCT00075114|"     The purpose of this study is to determine the capacity of self-efficacy to predict     maintaining a behavior change at four years post urinary control intervention.   "
170910|NCT00075140|"     The purpose of this study is to identify health management concerns and needs of family     members of asymptomatic and symptomatic persons with mutation in the gene for Huntington     Disease (HD).   "
170911|NCT00075153|"     The purpose of this study is to characterize the quality of life (QOL) and longitudinal     patterns of change in QOL outcomes in children and youth with HIV infection; to identify     demographic, social, disease status, treatment, and health care utilization factors that     predict longitudinal changes in outcomes; to develop a conceptual model that characterizes     the effects of specific factors that predict longitudinal changes in QOL; and to characterize     the influence of HIV symptoms on QOL outcomes in the domains of health perceptions, physical,     psychological, and social role functioning.   "
170932|NCT00075465|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin     as first-line therapy works in treating patients with locally advanced or metastatic     adenocarcinoma (cancer) of the stomach.   "
173730|NCT00107978|"     Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug,     telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin     structure infections.   "
170912|NCT00075166|"     This study will compare the effectiveness of craniotomy to that of stereotactic surgery (SRS)     for the treatment of metastatic brain tumors - tumors that first develop elsewhere in the     body and then travel to the brain. Craniotomy is surgical removal of the tumors through an     operation. SRS consists of highly focused radiation doses to the tumors. Neither treatment is     experimental and both have shown benefits to patients with metastatic brain tumors. This     study will determine whether one treatment is superior to the other in prolonging patient     survival.      Patients 21 years of age and older with one to three metastatic brain tumors may be eligible     for this study. Participants will have a medical history and physical examination, blood and     urine tests, an electrocardiogram, and chest x-ray. They will then be randomly assigned to     undergo either surgery or SRS. Before either procedure, patients will have a magnetic     resonance imaging (MRI) scan. MRI uses a strong magnetic field and radio waves to obtain     images of the brain. Patients scheduled for SRS will have a computed tomography (CT) scan in     addition to the MRI. CT uses X-rays to obtain images of the brain. During the CT, a contrast     agent is injected through an IV tube placed in a vein to enhance the CT images. For both the     MRI and CT tests, the patient lies on a table that slides into a cylindrical scanner. The MRI     usually lasts between 45 and 90 minutes, while the CT scan lasts for about 30 to 60 minutes.      Patients scheduled for surgery will have general anesthesia or local anesthesia with     sedation. They will be in intensive care after the surgery until their condition is stable.     Before being discharged home, they will have another MRI scan. The surgical sutures or     staples will be removed 7 to 10 days after surgery.      Patients scheduled for SRS will have their scalp numbed with medicine and their head will be     placed in a head frame. A CT scan will be done on the morning of the procedure to plan the     treatment. Around noon, the treatment, which consists of brief exposures to radiation, will     be administered with the patient positioned comfortably on a treatment couch. The treatment     will be completed in 1 to 2 hours, after which the head frame will be removed. After a brief     period of observation, the patient will be discharged home.      Patients will return to NIH for follow-up visits within 4 weeks after surgery or SRS and then     every 3 months after that for a medical history, physical examination, and MRI scan, and to     complete a quality of life questionnaire.   "
170914|NCT00075192|"     This is a multi-center, open label, randomized study. Patients will be randomized to one of     the following arms with an allocation ratio of 3:1, respectively: Arm A: CP-675,206 +     neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization,     patients will receive study treatment for three cycles (one cycle is defined as 28 days).     After completion of three cycles, patients will undergo a prostatectomy and pathology     assessments will be completed at a central laboratory, the Armed Forces Institute of     Pathology (AFIP) in Washington, DC.   "
170915|NCT00075205|"     This study will examine whether Rimonabant, a drug that blocks cannabinoid-1 (CB1) receptors     in the brain, affects alcohol consumption. Substances called endocannabinoids, which have     many of the same effects of marijuana, bind to CB1 receptors. Animal studies show that when     CB1 receptors are blocked, the animals consume less alcohol.      Healthy normal volunteers between 21 and 40 years of age who consume between 20 and 40     alcoholic drinks per week, drink at least 4 days a week, and are not seeking treatment for     alcoholism may be eligible for this study. Candidates are screened with a medical history,     including questions about alcohol and drug use, physical examination, blood and urine tests,     breath alcohol test, and electrocardiogram.      Participants are asked about their mental health history and use of alcohol, cigarettes and     illicit drugs, and fill out questionnaires evaluating their emotional state and personality.     Then, they begin a baseline evaluation in which they call a number at the NIH Clinical Center     for 21 days to report how much alcohol they drank that day. One week after starting the     baseline evaluation, they are randomly assigned to take either Rimonabant or placebo (a pill     with no active ingredient) for 2 weeks. Before starting the drug, they have a urine drug     screen and measurement of blood alcohol level. After 1 week on the test medication, they     return to the Clinical Center to monitor drug or placebo side effects, if any, and to have a     blood alcohol level test, urine drug screen, and blood tests for routine blood chemistries.     After 2 weeks on the test medication, they come to the Clinical Center at noon for an alcohol     self-administration test. Before the test, they are given a breath alcohol test and a urine     drug test. The results of both tests must be negative to continue in the study.      The alcohol self-administration test is videotaped. A heparin lock is placed in a vein in the     participant's arm. This small needle remains in the arm for the duration of the study to     avoid multiple needle sticks for blood draws. Blood is drawn periodically during the test to     determine routine laboratory values, cotinine level (assessment of smoking status), the     amount of Rimonabant or placebo in the body, and levels of various hormones. Thirty minutes     before the test begins and every 30 minutes during the test, participants complete     questionnaires and rating scales regarding their mood and desire to drink. Five minutes     before the test be...   "
170916|NCT00075218|"     A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal     stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to     imatinib treatment.   "
170917|NCT00075231|"     The purpose of this study is to determine whether a simplified lopinavir-ritonavir based     therapy will continue to keep the viral load to very low levels after initial treatment with     a combination of Kaletra® (lopinavir/ritonavir) plus Combivir® (lamivudine/zidovudine).   "
170918|NCT00075244|"     The main goal of this study is to assess the pharmacodynamic effects of different or more     frequent doses of Replagal compared to the standard dosing regimen. Replagal is a genetically     engineered form of alpha-Galactosidase A, an enzyme that normally breaks down a fatty     substance called globotriaosylceramide (Gb(3)). In patients with Fabry disease, GB(3) does     not function properly and therefore builds up causing problems with the kidneys, heart,     nerves, and blood vessels.      Male patients 18 years of age or older with Fabry disease who are not on dialysis and have     not received a kidney transplant may be eligible for this study.      Participants are randomly assigned to receive one of the following five regimens of Replagal     infusions, given through a vein over 20 to 80 minutes:      0.1 mg/kg body weight every week      0.2 mg/kg body weight every week      0.2 mg/kg body weight every other week      0.4 mg/kg body weight every week      0.4 mg/kg body wieght every other week      In the US, the infusions are given at the NIH Clinical Center. Vital signs are measured     before, immediately after, and 1 hour after each infusion.      Baseline evaluations are done on an inpatient or outpatient basis. Baseline tests include a     check of vital signs (temperature, respiratory rate, pulse rate, and blood pressure);     physical examination; laboratory tests; and review of treatment side effects. Evaluations are     also done at every infusion visit, and 1 week and 1 month after the last infusion.      Safety evaluations are done periodically and include vital sign measurements, physical     examination, blood and urine tests, review of drug side effects, electrocardiogram (ECG),     Holder monitor (2 hour ECG), and QSART (NIH only). The QSART (quantitative sudomotor axon     reflex test) measures the amount of sweat in a particular area of skin, mostly the forearm.     For this test, a cup partly filled with a liquid is strapped on the arm. A weak electric     current is turned on, stimulating the sweat glands, and the amount of sweat produced is     measured. There is a tingling sensation when the current is turned on.      Patients who complete the study will be offered the opportunity of receiving Replagal for 6     months in an extension study.   "
170919|NCT00075257|"     Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment     in reducing the relapse rate of depressive symptoms in subjects with major depressive     disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between     DVS-233 SR and placebo treatment groups by using survival analysis.      Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the     clinical global evaluation, functionality, general well-being, pain, and absence of symptoms     (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] < 7).   "
170920|NCT00075270|"     The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine     kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in     first line advanced or metastatic breast cancer.   "
170922|NCT00075296|"     This study will examine how the brains of depressed people function during learning and     respond to feedback. Participants perform a probabilistic reversal learning task to     determine whether depressed people perform worse on a task than non-depressed people when     they sometimes receive misleading negative feedback.      Right-handed healthy volunteers, people with major depression who are currently depressed or     have previously been depressed and people with bipolar depression between 18 and 50 years of     age may be eligible for this study. Candidates are screened with a medical and psychiatric     history, physical examination, electrocardiogram, blood and urine tests. They are also     interviewed to evaluate mood, sleep, energy, work and school performance, and social     relationships, and asked to answer questions to investigate whether any history of paranoia,     panic attacks, obsession, compulsions, suicidal thoughts, eating disturbances, and alcohol or     drug abuse is present. They complete rating scales for depression, anxiety, and negative     thinking; history of alcohol and tobacco use; physical movement; socioeconomic status;     overall level of functioning; and depression type. Finally, they undergo a battery of     neuropsychological tests to assess general intelligence, handedness, and specific cognitive     abilities, including memory and concentration.      Participants perform the probabilistic reversal learning task either in a testing room seated     in front of a computer or lying down while undergoing functional magnetic resonance imaging     (FMRI). FMRI is a diagnostic test that uses a strong magnet and radio waves to obtain     pictures of brain structure and function. For the scan, the subject lies on a narrow bed with     a plastic-encased metal coil close to the head. The bed slides into the scanner - a small     tunnel about 6 feet long. All subjects, whether in the testing room or in the MRI scanner,     undergo the learning task as follows:      Two patterns are presented on a computer screen. One pattern is designated correct and the     other incorrect. Subjects are asked to choose the correct pattern on each try and are     provided feedback as to whether the response was right or wrong. Sometimes the rule changes,     and the pattern that was correct is now wrong, and vice versa, so that the new correct     pattern must be chosen. In addition, misleading feedback is sometimes given intentionally,     indicating the subject chose the wrong pattern when in fact the response was correct.     Subjects should change their response only when they are sure that the rule has changed, and     not because they were incorrectly told that they were wrong. For patients undergoing MRI,     blood flow in the different areas of the brain is measured during the test.      After the test, outside the scanner, participants undergo additional tests of attention,     memory, and concentration like those that were administered during the screening procedures.   "
170997|NCT00076388|"     The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with     advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving     prior treatment with platinum-based chemotherapy.   "
170923|NCT00075335|"     Peripheral blood progenitor cells (PBPC) have become the preferred source of hematopoetic     stem cells for allogeneic transplantation because of technical ease of collection and shorter     time required for engraftment. Traditionally, granulocyte-colony stimulating factor (G-CSF)     has been used to procure the peripheral blood stem cell graft. Although regimens using G-CSF     usually succeed in collecting adequate numbers of PBPC from healthy donors, 5%-10% will     mobilize stem cells poorly and may require multiple large volume apheresis or bone marrow     harvesting. Although G-CSF is generally well tolerated in healthy donors, it may be     associated with bone pain, headache, myalgia and rarely life threatening side effects like     stroke, myocardial infarction and splenic rupture.      AMD3100, is a bicyclam compound that inhibits the binding of stromal cell derived factor-1     (SDF-1) to its cognate receptor CXCR4. CXCR4 is present on CD34+ hematopoetic progenitor     cells and its interaction with SDF-1 plays a pivotal role in the homing of CD34+ cells in the     bone marrow. Inhibition of the CXCR4-SDF1 axis by AMD3100 releases CD34+ cells into the     circulation, which can then be collected easily by apheresis. Recently, a published report     demonstrated that large numbers of CD34+ cells were rapidly mobilized in healthy volunteers     following a single subcutaneous injection of AMD3100. Remarkably, the number of CD34+ cells     collected by apheresis following a single injection of AMD3100 was comparable to the number     of CD34+ cells collected from historical controls receiving 5 days of G-CSF prior to stem     cell mobilization. Although the study population is relatively small, side-effects to this     agent have been mild and transient with no serious complications having been reported. The     ability to collect a large quantity of PBPC with a single injection of this drug makes this     an attractive agent for mobilizing donors of allogeneic PBPC. However, the immunologic     profiles of AMD3100 mobilized cells, in terms of lymphocyte content (T cell, B cell, NK cell,     immuno-regulatory T cell), T cell polarization status (TH1 versus TH2), status of antigen     presenting cells (DC1 versus DC2), alloreactive potential, and preservation of reactivity to     infectious agents (e.g. EBV, CMV) are unknown. Consequently, whether AMD3100 mobilized PBPC     would be suitable for use as an allograft is uncertain. In this study we will collect PBPCs     following a single subcutaneous injection of AMD3100 from healthy donors who have previously     had PBPC collected using standard G-CSF mobilization. The AMD3100 mobilized cells, G-CSF     mobilized cells, and circulating cells prior to both AMD3100 and G-CSF mobilization will be     analyzed in terms of cellular content and function of lymphocytes, NK cells, and antigen     presenting cells. AMD3100 mobilized PBPC will be collected for the purpose of research     studies and will not be used for therapeutic purposes.   "
170924|NCT00075348|"     RATIONALE: The identification of gene mutations in individuals who have or are at risk for     von Hippel-Lindau syndrome may allow doctors to better determine the genetic processes     involved in the development of cancer.      PURPOSE: This genetic study is finding gene mutations in participants with von Hippel-Lindau     syndrome or who are at risk for developing von Hippel-Lindau syndrome.   "
170925|NCT00075374|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, use different ways to stop tumor     cells from dividing so they stop growing or die. It is not yet known which docetaxel regimen     is more effective for non-small cell lung cancer.      PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel     in treating patients who have not previously received chemotherapy for unresectable stage     IIIB or stage IV non-small cell lung cancer.   "
170926|NCT00075387|"     This randomized phase II trial studies how well giving combination chemotherapy with or     without sodium thiosulfate works in preventing low platelet count while treating patients     with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin,     cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving     chemotherapy. It is not yet known whether combination chemotherapy is more effective with or     without sodium thiosulfate in preventing low platelet count during treatment for brain     tumors.   "
170927|NCT00075400|"     This phase II clinical trial studies the side effects and how well imatinib mesylate works in     treating patients with uterine cancer that has failed to respond to initial chemotherapy or     has re-grown after therapy. Imatinib mesylate may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
170928|NCT00075413|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating women     with locally advanced or metastatic breast cancer.   "
170929|NCT00075426|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients     with locally advanced or metastatic non-small cell lung cancer.   "
170930|NCT00075439|"     This phase II trial is studying how well gefitinib works in treating patients with     progressive metastatic neuroendocrine tumors. Gefitinib may stop the growth of tumor cells by     blocking the enzymes necessary for their growth.   "
170931|NCT00075452|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. It is not yet known     whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic     adenocarcinoma.      PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how     well they work compared to gemcitabine alone in treating patients with locally advanced or     metastatic unresectable pancreatic adenocarcinoma.   "
170972|NCT00076011|"     The primary purpose of this protocol is to determine the activity of AG 013736 in patients     with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.   "
170933|NCT00075478|"     This randomized phase III trial is studying total-body irradiation (TBI) and fludarabine     phosphate to see how it works compared with TBI alone followed by donor stem cell transplant     in treating patients with hematologic cancer. Giving low doses of chemotherapy, such as     fludarabine phosphate, and radiation therapy before a donor stem cell transplant helps stop     the growth of cancer cells. It also stops the patient's immune system from rejecting the     donor's stem cells. The donated stem cells may replace the patient's immune system cells and     help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from     happening. It is not yet known whether TBI followed by donor stem cell transplant is more     effective with or without fludarabine phosphate in treating hematologic cancer.   "
170934|NCT00075491|"     This randomized phase II trial is studying how well neoadjuvant and adjuvant fenretinide     works compared to adjuvant fenretinide alone in treating patients who are undergoing surgical     resection for recurrent glioblastoma multiforme. Chemotherapy drugs, such as fenretinide,     work in different ways to stop tumor cells from dividing so they stop growing or die. Giving     chemotherapy before surgery may shrink the tumor so that it can be removed. Giving     chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether     neoadjuvant and adjuvant fenretinide is more effective than adjuvant fenretinide alone   "
170935|NCT00075504|"     This phase II trial is studying how well giving 3-AP together with gemcitabine works in     treating patients with unresectable or metastatic bile duct or gallbladder cancer. Drugs used     in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells     from dividing so they stop growing or die. 3-AP may help gemcitabine kill more cancer cells     by making them more sensitive to the drug.   "
170936|NCT00075517|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways     to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel     works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.   "
170937|NCT00075543|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug     may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel and     oxaliplatin and to see how well they work in treating patients with stage III or stage IV     ovarian epithelial cancer.   "
170938|NCT00075556|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy, such as capecitabine, use different ways to stop tumor cells from dividing so     they stop growing or die. Combining radiation therapy with chemotherapy before surgery may     shrink the tumor so that it can be removed.      PURPOSE: This phase II trial is studying how well neoadjuvant radiation therapy and     capecitabine work in treating patients who are undergoing surgery for stage III or stage IV     colorectal adenocarcinoma.   "
170939|NCT00075569|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer or to treat early cancer. SGN-00101 may be effective in preventing the     development of cervical cancer in patients who have cervical intraepithelial neoplasia.      PURPOSE: This phase II trial is studying how well SGN-00101 immunotherapy works in preventing     cervical cancer in patients with grade III cervical intraepithelial neoplasia.   "
170940|NCT00075582|"     This phase III trial is studying how well combination chemotherapy and radiation therapy work     in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in     chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways     to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may     kill more tumor cells. It is not yet known which treatment regimen is more effective in     treating low-risk rhabdomyosarcoma.   "
170941|NCT00075595|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use     different ways to stop tumor cells from dividing so they stop growing or die. Giving more     than one chemotherapy drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving fluorouracil together with     leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic     unresectable colorectal cancer.   "
170942|NCT00075608|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma     cells, either by killing the cells or by stopping them from dividing. Having a stem cell     transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses     of chemotherapy to be given so that more plasma cells are killed. By reducing the number of     plasma cells, the disease may progress more slowly.      PURPOSE: This phase II trial is studying how well autologous stem cell transplant works in     treating patients with persistent or recurrent primary systemic (AL) amyloidosis.   "
170943|NCT00075621|"     RATIONALE: Autologous stem cell transplantation may be effective treatment for primary     systemic (AL) amyloidosis.      PURPOSE: This phase II trial is studying how well tandem (two) autologous stem cell     transplantation works in treating patients with primary systemic (AL) amyloidosis.   "
170944|NCT00075634|"     This phase I trial is studying the side effects and best dose of decitabine when given     together with doxorubicin and cyclophosphamide in treating children with relapsed or     refractory solid tumors or neuroblastoma. Drugs used in chemotherapy, such as decitabine,     doxorubicin, and cyclophosphamide, work in different ways to stop tumor cells from dividing     so they stop growing or die. Combining more than one drug may kill more tumor cells.   "
170945|NCT00075647|"     Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from     dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works     in treating patients with locally advanced or metastatic pancreatic cancer   "
170946|NCT00075660|"     RATIONALE: Drugs used in chemotherapy, such as 3-AP, work in different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have     locally recurrent or metastatic renal cell (kidney) carcinoma (cancer).   "
170947|NCT00075673|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to     stop tumor cells from dividing so they stop growing or die. Combining vinorelbine with     celecoxib may kill more tumor cells.      PURPOSE: Phase I trial to determine the effectiveness of combining vinorelbine with celecoxib     in treating women who have relapsed or metastatic breast cancer.   "
170948|NCT00075686|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as     cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to     them without harming normal cells. It is not yet known whether gemcitabine is more effective     with or without cetuximab in treating pancreatic cancer.      PURPOSE: This randomized phase III trial is studying giving gemcitabine together with     cetuximab to see how well it works compared to giving gemcitabine alone as first-line therapy     in treating patients with locally advanced unresectable or metastatic adenocarcinoma of the     pancreas.   "
170949|NCT00075699|"     RATIONALE: Active symptom control may decrease chest pain, breathlessness, sweating, and     general discomfort in patients with malignant pleural mesothelioma. It is not yet known if     active symptom control is more effective with or without chemotherapy.      PURPOSE: This randomized phase III trial is studying active symptom control and chemotherapy     to see how well they work compared to active symptom control alone in treating patients with     malignant pleural mesothelioma.   "
170950|NCT00075712|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink     the tumor so that it can be removed; giving chemotherapy after surgery may kill any remaining     tumor cells. It is not yet known whether giving chemotherapy before and after surgery is more     effective than giving chemotherapy after surgery in treating ovarian epithelial, fallopian     tube, or primary peritoneal cavity cancer.      PURPOSE: This randomized phase II/III trial is studying how well giving chemotherapy before     and after surgery works and compares it to giving chemotherapy after surgery alone in     treating patients with newly diagnosed advanced ovarian epithelial, fallopian tube, or     primary peritoneal cavity cancer.   "
170951|NCT00075725|"     RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and     leucovorin calcium (LCV), work in different ways to stop cancer cells from dividing so they     stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet     known which combination chemotherapy regimen is more effective in treating acute     lymphoblastic leukemia.      PURPOSE: This randomized phase III trial is studying dexamethasone to see how well it works     compared to prednisone during induction therapy. This trial is also studying methotrexate and     leucovorin calcium to see how well they work compared to methotrexate alone during     maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia.   "
170952|NCT00075738|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, irinotecan, leucovorin, and     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or     die. Giving more than one chemotherapy drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy as     first-line therapy works in treating patients with metastatic esophageal cancer.   "
170953|NCT00075751|"     Phase II trial to study the effectiveness of combining bortezomib with gemcitabine and     carboplatin in treating patients who have advanced or recurrent non-small cell lung cancer     that has not been previously treated with chemotherapy. Drugs used in chemotherapy, such as     gemcitabine and carboplatin, work in different ways to stop tumor cells from dividing so they     stop growing or die. Bortezomib may stop the growth of tumor cells by blocking the enzymes     necessary for their growth. Bortezomib may also help gemcitabine and carboplatin kill more     tumor cells by making the cells more sensitive to the drugs   "
170954|NCT00075764|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of     estrogen. It is not yet known whether anastrozole is more effective with or without     fulvestrant in treating breast cancer.      PURPOSE: This randomized phase III trial is studying giving anastrozole together with     fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in     treating postmenopausal women with metastatic breast cancer.   "
170955|NCT00075777|"     RATIONALE: Valproic acid may help stop the growth of Kaposi's sarcoma cells by blocking the     enzymes necessary for tumor cell growth.      PURPOSE: This clinical trial is studying valproic acid in treating patients with HIV-related     Kaposi's sarcoma.   "
170956|NCT00075803|"     The study is designed as a Phase III, randomized, double-blind, multicenter, prospective,     comparative study of fluconazole versus voriconazole for the prevention of fungal infections     in allogeneic transplant recipients. Recipients will be stratified by center and donor type     (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm     in a 1:1 ratio.   "
170957|NCT00075816|"     The study is designed as a Phase III, randomized, open label, multicenter, prospective,     comparative trial of granulocyte colony stimulating factor (G-CSF)-mobilized peripheral blood     stem cells (PBSC) versus marrow from unrelated donors for transplantation in patients with     hematologic malignancies. Recipients will be stratified by transplant center and disease risk     and will be randomized to either the PBSC or marrow arm in a 1:1 ratio.   "
170958|NCT00075829|"     The study is designed as a Phase III, multi-center trial of tandem autologous transplants     versus the strategy of autologous followed by Human Leukocyte Antigen (HLA)-matched sibling     non-myeloablative allogeneic transplant. Study subjects will be biologically assigned to the     appropriate arm depending on the availability of an HLA-matched sibling. There is a nested     randomized phase III trial of observation versus maintenance therapy following the second     autologous transplant for patients on the tandem autologous transplant arm.   "
170959|NCT00075842|"     RATIONALE: The herb Valeriana officinalis (valerian) may promote sleep. It is not yet known     whether valerian is effective in improving sleep in patients who are receiving adjuvant     therapy for cancer.      PURPOSE: This randomized phase III trial is studying how well valerian improves the quality     of sleep in patients who are receiving adjuvant therapy (radiation therapy, chemotherapy, or     hormone therapy) for cancer.   "
170960|NCT00075855|"     RATIONALE: The hormone testosterone may improve the libido (sex drive) in women. It is not     yet known whether testosterone is effective in improving libido in female cancer survivors.      PURPOSE: This randomized phase III trial is studying how well low-dose testosterone works to     improve libido in postmenopausal cancer survivors.   "
170961|NCT00075868|"     RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who     are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether     octreotide is effective in treating diarrhea.      PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing     diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.   "
170962|NCT00075881|"     This phase II trial studies how well bortezomib works in treating patients with newly     diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth.   "
170963|NCT00075894|"     RATIONALE: Drugs used in chemotherapy, such as alanosine, use different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of alanosine in     treating patients with high-grade progressive or recurrent malignant gliomas.   "
170964|NCT00075907|"     The purpose of this study is to compare the effectiveness of anti-HIV drug regimens with or     without a protease inhibitor (PI) in HIV infected adolescents. It will also determine if     monitoring drug levels and adjusting the dose as necessary improves the effectiveness of     these regimens.   "
170965|NCT00075920|"     This study will examine heart function using two imaging techniques - echocardiography     (ultrasound) and magnetic resonance imaging (MRI) - to evaluate newly developed software for     echocardiograph machines. MRI and ultrasound both provide images of the heart structure and     function. MRI uses a magnetic field and radio waves to obtain the pictures, while     echocardiography uses sound waves.      Patients with any form of heart disease and healthy volunteers 21 years of age and older may     be eligible for this study. Candidates must be and able to undergo magnetic resonance imaging     and must not have an irregular heart rhythm, heart valve disease, a pacemaker, defibrillator     implant, insulin pump, or other metallic implant.      Participants will have two ultrasound examinations and two magnetic resonance imaging     examinations, as described below. All the tests will be completed within 24 to 48 hours.      Echocardiography :      For this test, a small probe is passed over the chest. Sound waves emitted from the probe     bounce off the heart and are beamed back into the echo machine where they are recorded. The     sonographer does a baseline test, which is evaluated by the physician. Then, after a 10- to     20-minute break, portions of the test are repeated. The entire exam takes about 2 hours.      Magnetic Resonance Imaging:      For MRI, the subject lies on a table that slides into a long doughnut-shaped scanner. A small     tube is placed in a vein in the hand or arm to give fluids and to infuse gadolinium, a     contrast material that brightens the images. Heart rate and blood pressure are monitored     during the study, which takes about 3 hours.   "
170966|NCT00075933|"     ARQ 501, an investigational anticancer drug, is intended to selectively kill cancer cells and     spare normal cells by restoring and activating cellular checkpoints known to be defective in     cancer using the Company's unique biology platform, Activated Checkpoint Therapy™ (ACT).      ARQ 501 has the potential for improved activity and reduced toxicity over other molecular     approaches and traditional cancer chemotherapy.   "
170967|NCT00075946|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. It is not yet     known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and     comparing them to see how well they work in treating patients with low tumor burden indolent     stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.   "
170968|NCT00075959|"     This study will determine if NXY-059 is safe in patients with an acute stroke caused by     bleeding in the central nervous system. The primary objective was to assess the safety and     tolerability of NXY-059 compared to placebo.   "
170969|NCT00075972|"     Objectives:      The long term objectives of this research program are:        1. To advance the mission of the VHA Boston Healthcare System to deliver comprehensive          quality healthcare that meets the needs of patients (in this case, who have been          unresponsive to standard smoking cessation treatment) through research and clinical          care.        2. To expand upon our knowledge of the feasibility and effectiveness of commonly-used          treatments for nicotine dependence.        3. To further explore variables related to mood and coping that may contribute to or          prevent successful reduction and cessation of smoking behavior among veterans.      The short-term objectives of this project are:        1. To evaluate the feasibility and effectiveness of two adjunctive treatments (a          mood-focused exposure-based treatment, Mood Tolerance, with Nicotine Replacement Therapy          [MTNRT] and mood-focused affect-management treatment, Mood Management, with Nicotine          Replacement Therapy [MMNRT]) aimed at reduction and cessation of smoking behavior among          veterans who were previously non-responders to smoking cessation treatment in the VA.        2. To inform equivocal findings in the literature regarding the role of mood as trigger for          smoking behavior.        3. To explore selected mood, coping, and individual difference variable that may be          predictive of successful abstinence from cigarettes among veterans.   "
170970|NCT00075985|"     This is a prospective observational cohort study that is in the process of enrolling and     following patients on warfarin therapy by utilizing anticoagulation clinics in VA hospitals     across the US. There are currently 14 sites actively enrolling patients in the study. For     each octogenarian enrolled a randomly selected patient with atrial fibrillation (AF) younger     than 80 years of age from the same clinic and receiving warfarin for approximately the same     duration is enrolled.   "
170971|NCT00075998|"     -  Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the          efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by          subcutaneous (SC) injection, compared with placebo, in patients with IPF        -  Enrollment: Approximately 800 patients will be enrolled from approximately 80 centers in          North America and Europe        -  Randomization: 2:1 active-to-placebo ratio        -  Duration: at least 2 years active drug or placebo (rescue therapy will be permitted for          patients who meet predefined criteria)   "
170973|NCT00076024|"     The primary purpose of the study is to determine the time to progression of the combination     of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not     received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study     is to determine the dose of study drug that can be given with docetaxel administered on an     every 3 week schedule.   "
170974|NCT00076037|"     The effectiveness of a vaccine can be improved by using a prime boost strategy or by using     an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer)     followed by the administration of another type vaccine (the booster). An adjuvant is a     substance that can enhance the immune response when given at the same time as a vaccine.      This study will evaluate the safety of and immune response to a vaccine designed to be used     as part of a prime boost strategy. The study will also evaluate the vaccine when given with     an adjuvant. The vaccine in this study is not produced from live HIV or from infected cells.     It does not contain HIV, and it cannot cause HIV infection.   "
170975|NCT00076050|"     The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring     compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women     who have recently gone through menopause.      Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally     occurring spinal bone loss and improve biological and other emotional changes of menopause.   "
172944|NCT00105521|"     The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is     effective in the treatment of dyskinesia associated with dopaminergic treatment of     Parkinson's disease (PD).   "
170976|NCT00076063|"     This study will test the immune system response to and safety of two HIV vaccines alone and     in combination: ALVAC-HIV (vCP1452) and LIPO-5. ALVAC-HIV (vCP1452) uses a canarypox virus     with man-made parts of HIV attached to it. The canarypox virus cannot cause disease in     people. LIPO-5 is a mixture of five man-made proteins similar to proteins found in HIV.      These vaccines are not produced from live HIV or from infected cells and do not contain the     virus. It is not possible to become infected with HIV from these vaccines.   "
170977|NCT00076076|"     The purpose of this study is to confirm the dose of roflumilast to be used for asthma     management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on     pulmonary function and asthma symptoms.   "
170978|NCT00076089|"     The purpose of this study is to determine whether roflumilast is effective in the treatment     of exacerbations in patients with chronic obstructive pulmonary disease (COPD).   "
170979|NCT00076102|"     Background:      Neurofibromatosis Type 1 (NF1) is an autosomal dominant, progressive genetic disorder     characterized by diverse clinical manifestations. Patients with NF1 have an increased risk of     developing tumors of the central and peripheral nervous system including plexiform     neurofibromas, which are benign nerve sheath tumors that may cause severe morbidity and     possible mortality. The histopathology of these tumors suggests that events connected with     formation of fibroblasts might constitute a point of molecular vulnerability. Gene profile     analysis demonstrates overexpression of fibroblast growth factor, epidermal growth factor,     and platelet-derived growth factor in plexiform neurofibromas in patients with NF1.     Pirfenidone is a novel antifibrotic agent that inhibits these and other growth factors.     Clinical experience in adults has demonstrated that pirfenidone is effective in a variety of     fibrosing conditions and pirfenidone is presently under study in a phase II trial for adults     with progressive plexiform neurofibromas. A phase I trial of pirfenidone in children and     young adults with NF1 and plexiform neurofibromas was completed, and has established the     phase II dose (the dose resulting in a mean drug exposure [AUC] not more than 1 standard     deviation below the mean drug exposure [AUC] in adults who received pirfenidone at the dose     level demonstrating activity in fibrosing conditions). Pirfenidone has been well tolerated.      Objectives:      To determine whether pirfenidone increases the time to disease progression based on     volumetric measurements in children and young adults with NF1 and growing plexiform     neurofibromas.      To define the objective response rate to pirfenidone in NF1-related plexiform neurofibromas.      To describe and define the toxicities of pirfenidone.      Eligibility:      Individuals (greater than or equal to 3 years to less than or equal to 21 years of age) with     a clinical diagnosis of NF1 and inoperable, measurable, and progressive plexiform     neurofibromas that have the potential to cause substantial morbidity.      Design:      The phase II dose will be used in a single stage, single arm phase II trial The natural     history of the growth of plexiform neurofibromas is unknown. For this reason, time to disease     progression on the placebo arm of an ongoing National Cancer Institute (NCI) Pediatric     Oncology Branch (POB) placebo-controlled, double-blind, cross-over phase II trial of the     farnesyltransferase inhibitor R115777 for children and young adults with NF1 and progressive     plexiform neurofibromas.      Funding source - Food and Drug Administration (FDA) Office of Orphan Products Development     (OOPD)   "
170980|NCT00076115|"     A clinical study to determine the safety and effectiveness of risperidone compared with     placebo in the treatment of bipolar disorder (manic or mixed type) in children and     adolescents aged 10 to 17 years.   "
170981|NCT00076141|"     The purpose of this study is to gather a mixed racial group of relatively healthy male     Veterans (for example, White, African-American, and Hispanic), who are at least 50 years of     age. These men will be followed to see what types of diseases they develop and to determine     if racial differences in lifestyle, blood test results, or genes are related to the types of     diseases that are found. Diseases of particular interest are prostate cancer, other cancers,     cardiovascular disease (for example, heart attacks and stroke), high blood pressure and     diabetes. The group to be followed will consist of about 16,000 men recruited from about 40     VA Medical Centers across the country. Each man will be followed for at least five years     depending on when he enters the study.   "
170982|NCT00076154|"     This study will identify living veterans with amyotrophic lateral sclerosis (ALS) through a     national registry that is being developed. Diagnosis of ALS will be verified by study     neurologists via medical record review. Registry participation includes a bi-annual telephone     interview to collect functional status data.   "
170983|NCT00076180|"     This study will examine the use of the humanized Mik-beta-1 (Hu-Mik-beta1) antibody in     patients with T-cell large granular lymphocytic leukemia (T-LGL). Patients with T-LGL often     have reduced white blood cells, red blood cells, and platelets, and increased numbers of     abnormal cells called large granular lymphocytes (LGLs). Patients may have recurrent     infections, anemia, or abnormal bleeding. Hu-Mik-beta1 attaches to LGL cells and blocks the     action of growth factors called interleukins that stimulate LGL growth. Blocking these     interleukins may stop T-LGL leukemia cells from growing. This study will determine the dose     and frequency of treatment with Hu-Mik-(SqrRoot) 1 that can safely be given to patients to     coat the surface of their leukemic cells with antibody, determine how long the antibody lasts     in the blood after injection, and examine the side effects and possible benefits of the drug     in these patients.      Patients age 18 or older with T-LGL may be eligible for this study. Candidates will be     screened with a medical history and physical examination, review of pathology studies, skin     biopsy, evaluation of rheumatoid arthritis if present, chest x-ray, computerized tomography     (CT) scans and other imaging studies as needed, bone marrow biopsy, and blood and urine     tests.      Participants will receive a single dose of Hu-Mik-beta1 by a 90-minute infusion through a     vein. Groups of patients will be treated with increasing doses (0.5, 1.0, and 1.5 mg/kg) of     the antibody. Patients who develop serious drug side effects are taken off the study. The     treatment requires a 3- to 4-day hospital stay. In addition to Hu-Mik-(SqrRoot) 1 treatment,     patients will undergo the following tests and procedures:        -  Collection of blood for 8 days following the dose of Hu-Mik-beta1 to measure blood          levels of the antibody.        -  Follow-up visits of 1 to 2 days at 22, 29, and 43 days after the dose of the antibody          and then every 3 months for a total of 9 months.        -  Bone marrow aspirate and biopsy if one has not been done within 6 weeks before entering          the study, and a repeat biopsy if complete remission of T-LGL is achieved after          completing treatment. For the biopsy, an area of the hip is numbed and a special needle          is used to draw bone marrow from the hipbone.        -  Imaging studies, such as chest x-ray and CT scan of the body after completing treatment          if the screening scans showed abnormalities due to the T-LGL leukemia.        -  Lymph node biopsy in individuals with enlarged superficial lymph nodes due to T-LGL          leukemia to see if the treatment is reaching the leukemia in the lymph nodes.      There may or may not be a direct benefit from participating in this study. However, the     results may help in the treatment of future patients.   "
170985|NCT00076219|"     This is a multi-center, prospective, randomized, parallel-group trial of an intensive     strategy vs conventional strategy of renal replacement therapy for the treatment of acute     renal failure secondary to acute tubular necrosis in critically ill patients. The primary     hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10%     compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to     45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality,     1-year all cause mortality, and recovery of renal function by day 28. The study will recruit     1164 patients over a period of 3 years, 8 months and each patient will be actively followed     for 60 days.   "
170986|NCT00076232|"     Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence     of genital sores is a significant risk factor for becoming infected with HIV. This study will     test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes     drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men     who sleep with men (MSM).      Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition,     twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection     among high risk, HSV-2 seropositive WSM and MSM.   "
170987|NCT00076245|"     This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating     seasonal affective disorder (SAD), commonly called the winter blues.   "
170989|NCT00076271|"     This study will evaluate and treat children or adults with inherited or developmental eye     conditions. It will allow specialists in pediatric ophthalmology, genetic ophthalmology, and     ocular motility at the National Eye Institute (NEI) to learn more about the course of various     pediatric, genetic, developmental, and eye movement diseases thorough long-term observation     and treatment. It will also serve as the first step in determining the eligibility of     patients who may wish to enroll in other NEI clinical research studies or undergo standard     eye treatments.      Children with eye conditions, especially inherited or developmental conditions, and adults     with eye disorders that began in childhood or that likely have a genetic or developmental     component may be eligible for this study. Participants will undergo some or all of the     following procedures:        -  Medical history, including family history.        -  Physical examination and possibly routine blood tests, x-rays tests, standard eye          movement recordings, questionnaires, and specialized procedures when needed.        -  Complete eye examination, including vision test, visual perception, eye pressure (if          possible), dilation of the pupils to examine the back of the eye (lens, vitreous, and          retina).        -  Photographs of the eyes.        -  Oculography (eye movement recordings) in patients for whom testing will aid in          diagnosis. This test is done either with goggles placed over the eyes or with a contact          lens placed on each eye. When the goggles or lenses are in place, the subject looks at a          series of red targets on a computer screen.        -  Electroretinography (ERG) in patients with suspected retinal degeneration. This is a          test of the electrical function of the eyes. Before the test, patients sit in a dark          room for 30 minutes with their eyes patched. A small electrode (silver disk) is taped to          their forehead. The eye patches are then removed, the eyes are numbed with drops, and          contact lenses are placed in the eyes. The contact lenses sense small electrical signals          generated by the retina when lights flash. During the ERG recording, the patient looks          inside a large empty bowl. A light flashes, first in the dark and then with a light          turned on inside the bowl. The test takes 1 hour or less.      Participants are followed up to 6 times a year for 3 years, depending on the diagnosis and     treatment.   "
170990|NCT00076284|"     This study will determine which of four doses of GW873140 can safely be given to adults to     lower the amount of virus (HIV-1) in the body. GW873140 is a new type of anti-HIV drug called     a CCR5 receptor antagonist. CCR5 is a receptor on T cells (a type of white blood cell) where     HIV-1 enters and then infects the cell. GW873140 is intended to block the CCR5 receptor so     that HIV-1 cannot enter the cell.      HIV-1-infected patients 18 years of age and older may be eligible for this study. Candidates     are screened with a medical history and physical examination, electrocardiogram, and blood     and urine tests. Some of the blood drawn is used to test the patient's HIV-1 type to see if     the study drug might lower the amount of HIV-1 in the blood. Women who can become pregnant     have a pregnancy test.      Participants are hospitalized for 12 days. They are randomly assigned to take one of the     following four treatments for 10 days: 1) 200 mg of GW873140 once a day, or placebo (a     look-alike pill with no active ingredient); 2) 200 mg of GW873140 twice a day, or placebo; 3)     400 mg of GW873140 once a day, or placebo; or 600 mg of GW873140 twice a day, or placebo.     Participants record the meals they eat on a diary card. In addition, they undergo the     following tests and procedures:      During treatment        -  Assessment of HIV classification (day 1)        -  Review of meal diary cards (days 1,2,3,4,5,8, and 10)        -  Review of any HIV-associated conditions, other medications taken besides the study drug,          and well-being (days 1,2,3,4,5,8,10, and 11)        -  Check of vital signs, including blood pressure, pulse, and temperature (days          1,2,3,4,5,6,7,8,10, and 11)        -  Weight assessment (days 1 and 10)        -  Electrocardiogram to measure the electrical activity of the heart (days 1,2,3,8, and 10)        -  Blood draws for routine laboratory tests, to measure T-cell counts, and to measure HIV          levels (days 1,2,5,10, and 11)        -  Urine tests (days 1 and 10)      Post-treatment        -  Blood tests to monitor the effect of GW873140 on lowering HIV counts (days 12, 15, 17,          and 19)      Follow-up visit (2 weeks after last drug dose--day 24)        -  Review of medications taken and general well-being        -  Check of vital signs        -  Physical examination        -  Blood and urine tests.   "
170991|NCT00076310|"     The goal of this clinical research study is to learn if giving the new drug, Tarceva®     (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective     in the treatment of metastatic or recurrent head and neck cancer. The safety of this     treatment will also be studied.   "
170992|NCT00076323|"     This study will evaluate a new and safe testing method for identifying medicines that can     cause problems in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. We are     looking for volunteers with G6PD deficiency who would be willing to donate blood samples.   "
170993|NCT00076336|"     This research study was conducted to compare the safety and effectiveness of the     investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by     the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The     results for patients taking LdT will be compared to results for patients taking lamivudine.   "
170994|NCT00076349|"     SUMMARY:      This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1     followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will     repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if     tumor status improves and there are no unacceptable side effects. Patients will be followed     for up to 2 years or until disease progression.      RATIONALE:      Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination     of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical     study with Non-Hodgkin's lymphoma patients.      PURPOSE:      This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients     with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.   "
171052|NCT00077181|"     Drugs used in chemotherapy, such as cytarabine, work in different ways to stop cancer cells     from dividing so they stop growing or die. 3-AP may help cytarabine kill more cancer cells by     making them more sensitive to the drug. This phase I trial is studying the side effects and     best dose of 3-AP when given with high-dose cytarabine in treating patients with advanced     hematologic malignancies   "
171053|NCT00077194|"     This phase II trial is studying how well FR901228 works in treating patients with relapsed or     refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as FR901228, work in     different ways to stop tumor cells from dividing so they stop growing or die.   "
170995|NCT00076362|"     This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally     occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ     that secretes hormones). The purpose of this trial is to see how an investigational treatment     controls the hormone insulin by lowering the level of insulin in the body resulting in a     weight loss in children who are at least 6 years of age but less than 18 years of age. Some     children in this trial will receive placebo.      To qualify for this study, you and your child's doctor must feel that your child's weight is     inadequately controlled within a year from the time of injury to the hypothalamus or tumor of     the hypothalamus. This study will help to determine if an investigational treatment is of     benefit in controlling a child's weight.   "
170996|NCT00076375|"     Nanocrystalline silver (very small particles of silver) is the active ingredient in Acticoat     dressings, which have been approved for the treatment of burns and other wounds. Silver has     been used for decades as an effective antimicrobial agent. In animal studies, nanocrystalline     silver cream (NPI) has also demonstrated anti-inflammatory activity. Thus, nanocrystalline     silver cream is being evaluated in the treatment of inflammatory skin conditions such as     atopic dermatitis (eczema).      Approximately 180 study subjects with a definitive diagnosis of mild to moderate eczema will     be enrolled in this study. Subjects will be randomly assigned to treatment with placebo, 0.5%     NPI or 1% NPI for the 6-week treatment period. Assessments of treatment effect and safety     will be performed weekly. Upon completion of the study, subjects may be eligible for 12 weeks     of open-label treatment with 1% NPI.   "
170998|NCT00076401|"     The purpose of this study is to determine if the drug motexafin gadolinium will be an     effective treatment for patients who have chronic lymphocytic leukemia (CLL) that has come     back after treatment or that has stopped responding to treatment.   "
170999|NCT00076414|"     This study will examine how the anti-HIV protease inhibitor lopinavir/ritonavir (Kaletra®     (Registered Trademark)) affects the function of the endothelium (lining of the arteries).     Medications such as protease inhibitors can dramatically change the course of HIV infection     in many patients; however, among their side effects is development of abnormal lipid levels     resulting in high cholesterol and insulin resistance. These side effects may damage the     lining of the arteries that supply blood to the heart, leading to premature coronary artery     disease. The study will determine whether lopinavir/ritonavir directly affects endothelial     function and whether it alters cholesterol levels, glucose tolerance, and markers of     inflammation in people who take the drug for 4 weeks.      Healthy normal volunteers between 18 and 40 years of age may be eligible for this study.     Candidates must be HIV-negative and have no history of heart disease, hypertension, or     diabetes mellitus. They must not have smoked for at least 6 weeks before entering the study.     Volunteers will be screened with a medical history, physical examination, blood tests     (including a pregnancy test for women of childbearing potential), and electrocardiogram. In     addition, candidates will have an oral glucose tolerance test (see description below).      Participants will undergo the following procedures:        -  Lopinavir/ritonavir: 4 weeks (3 capsules twice a day) beginning study day 1        -  Flow-mediated vasodilatation test (study days 0 and 29) - An ultrasound device for          measuring the size of the brachial artery (artery in the upper arm) is placed just above          the elbow. The size of the artery is measured before and 5 minutes after blood flow to          the arm is stopped for 5 minutes, using a blood pressure cuff. The artery is also          measured before and after taking nitroglycerin, a medicine that dilates blood vessels.          These measurements tell how well the drug treatment works on the cells lining the          brachial artery, which is an indicator of coronary artery function. This test takes          about 1.5 hours.        -  Forearm blood-flow test (study days 1 and 30): Small tubes are inserted into an artery          and vein in the forearm at the inside of the elbow. Blood pressure cuffs are placed          around the upper arm and wrist, and a strain gauge (a rubber band-like device) is placed          around the forearm. When the blood pressure cuffs are inflated, blood flows into the          forearm, stretching the strain gauge at a rate proportional to the blood flow. When the          devices are in place, a salt water solution is injected in the small tube in the artery.          After 20 minutes, small doses of the following drugs are given through the catheter at          various intervals: 1) L-NMMA (blocks production of nitric oxide, a substance produced by          the blood vessels that causes them to dilate); 2) sodium nitroprusside (dilates blood          vessels, increasing blood flow); 3) acetylcholine (lowers blood pressure); and 4)          acetylcholine plus L-NMMA. The effect of the different drugs on blood flow in the          forearm is measured. The study takes about 2 hours to complete.        -  Blood tests (screening and study days 1,15, 30, and 44)        -  Electrocardiogram (at screening and on study day 30)        -  Oral glucose tolerance test (at screening and on study day 30) - A blood sample is          collected. Then, the subject drinks 300 milliliters of a glucose solution (a liquid that          contains sugar dissolved in water). Two hours after drinking the solution, blood is          drawn again to examine how the body responds to the increase blood sugar levels.   "
171000|NCT00076427|"     This study will collect quantities of white blood cells from patients infected with the     hepatitis C virus (HCV) for research on the interactions between HCV and the human     immunodeficiency virus (HIV) in people infected with both of these agents. Several studies     have shown that infection with HIV adversely affects liver disease due to HCV.      Patients 18 years of age and older who are infected with both HCV and HIV or with HCV alone     may be eligible for this study. Candidates must not have liver failure and must not be     undergoing treatment for HCV at the time of enrollment.      Participants will undergo leukapheresis to collect white blood cells. This procedure allows     collection of larger numbers of cells than would be possible with simple blood drawing. For     the procedure, blood is removed through a needle in the vein of one arm and spun in a machine     that separates the blood into its components. The white cells are extracted and the rest of     the blood is re-infused through the same needle or through a needle in the other arm. The     procedure takes approximately 1-3 hours, depending on the amount of white cells being     collected. A maximum of three leukapheresis procedures are done. If additional procedures are     required, the patient will sign a new consent form. Procedures will be limited to no more     than three times a year, or once every 4 months.   "
171001|NCT00076440|"     ALADDIN is a research study to investigate the safety and effectiveness of leuprolide (a     hormone drug) to improve the cognitive function and slow the progression of Alzheimer's     disease (AD) in men 65 years and older with mild to moderate Alzheimer's disease who reside     in the community.   "
171002|NCT00076453|"     Osteoarthritis is a degenerative joint disease and is the most common form of arthritis. This     study will evaluate the effectiveness of customized shoe inserts in controlling and relieving     the pain of knee osteoarthritis.   "
171003|NCT00076466|"     This study will determine: 1) whether learning a task with the dominant hand is accompanied     by changes in the area of the brain that controls hand movement, and 2) how the brain is able     to make these changes. Previous studies have shown that practicing a motor task can change     brain excitability, but it is not known how well brain excitabilities are changed during     motor learning. This study will measure changes in activity of the part of the brain that     controls hand movement before, during, and after exercising the hand on a response pad.      Healthy normal volunteers between 18 and 40 years of age may be eligible for this study.     Candidates who have not been evaluated at NIH within the past year will be screened with a     brief interview about their current state of health and clinical and neurological     examinations. Participants will undergo the following procedures:      Learning a finger movement/reaction time task      For this procedure, participants sit in front of a computer monitor with the index, middle,     ring, and little fingers placed flat on four corresponding buttons of a response pad. They     are asked to press one of the four buttons as fast as they can in response to an asterisk     displayed on the monitor. The position of the asterisk indicates which button to push.     Subjects perform nine sets of 120-button pushes with a 15-minute rest between each set.     During the rest period, subjects undergo transcranial magnetic stimulation (described below),     which causes twitches in the hand muscles. The electrical activity corresponding to the     twitches is recorded by attaching electrodes (small metal disks) to the skin over the hand     muscles.      Transcranial magnetic stimulation      For this test, an insulated wire coil is held over the scalp. A brief electrical current     passes through the coil, creating a magnetic pulse that electrically stimulates the brain.     The subject hears a click and may feel a pulling sensation on the scalp under the coil. The     stimulation may also cause twitching in the muscles of the face, arm, or leg. During the     stimulation, the subject may be asked to tense certain muscles slightly or perform other     simple actions.   "
171004|NCT00076479|"     This study will examine in healthy individuals and in patients with aphasia (a language     disturbance that is usually caused by stroke, brain disease, or injury) which parts of the     brain are involved in naming everyday objects. In most people, language and speech originate     in the left side of the brain. When this side of the brain is damaged, language function is     often impaired. Often, however, function partly recovers, possibly because the right half of     the brain takes over some language functions when the left half is injured.      Healthy volunteers and patients with aphasia due to stroke may be eligible for this study.     All candidates must be 18 years of age and older. Patients' aphasia must have occurred as the     result of a stroke that occurred more than 12 months before entering the study. In addition,     their stroke must not have affected the brainstem or cerebellum. Candidates will be screened     with a medical history, brief physical examination, and questionnaire about handedness.     Participants will undergo the following tests and procedures:      Session 1: Magnetic resonance scanning (MRI)      MRI is a diagnostic and research tool that uses a strong magnetic field and radio waves to     obtain images of body organs and tissues, including the brain. The subject lies in a     cylindrical machine for up to 60 minutes. Loud thumping noises occur when the radiofrequency     circuits are switched; this noise can be muffled by the use of earplugs.      Sessions 2 and 3: Picture naming during transcranial magnetic stimulation (TMS)      For transcranial magnetic stimulation, a wire coil is held on the subject's scalp. A brief     electrical current is passed through the coil, creating a magnetic pulse that stimulates the     brain. The subject hears a click and feels a pulling sensation on the skin under the coil.     There may also be a twitch in the muscles of the arm or leg. During the TMS, subjects are     asked to name pictures of common everyday objects that appear on a computer screen. They are     asked to name them as fast and as accurately as possible. Their voice is recorded to     determine the accuracy of their answers and the time it takes to answer. Subjects may also be     asked to tense certain muscles slightly or perform other simple actions during the TMS to     position the coil properly.   "
171006|NCT00076505|"     This study will examine and compare blood samples from healthy volunteers and patients with     Parkinson's disease to identify abnormalities associated with Parkinson's disease. Disease     symptoms include slowness of movement, hand or leg shaking, and stiffness. Some patients have     difficulty with balance. Information from this study may provide information on how     Parkinson's disease affects the brain and body, and may help lead to a test for earlier     diagnosis.      Healthy volunteers and patients with Parkinson's disease who are 18 years of age or older may     enroll in this study. Participants will undergo the following procedures:        -  Physical examination, including evaluation of strength, feeling, coordination, and          balance        -  Blood drawing: 150 milliliters (about 10 tablespoons) of blood will be drawn        -  Personal and family medical history        -  Consent to access medical records for research purposes      Blood samples will be examined for:        -  Genetic analysis        -  Study of specific proteins and lipids        -  Study of mitochondria (parts of cells that make energy)   "
171007|NCT00076518|"     The purpose of this study is to determine the effectiveness of fish oil supplements combined     with the drug fenofibrate in treating elevated triglyceride levels in people taking anti-HIV     drugs. The participants in this study will have shown no response to fish oil supplements or     fenofibrate alone.   "
171008|NCT00076531|"     Phase III trial using an injectable for treatment of prostate cancer.   "
171009|NCT00076544|"     The purpose of this open-label study is to give chronic severe pain patients with existing     intrathecal pump systems access to ziconotide.   "
171030|NCT00076856|"     The purpose of this study is to demonstrate improvement in overall survival for the     combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT     alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS     progression with the addition of TMZ to WBRT.   "
171010|NCT00076557|"     In this study a modified virus called adeno-associated virus (AAV) will be used to transfer a     normal gene for human clotting factor IX into patients with severe hemophilia B (AAV human     Factor IX vector). Gene therapy is a very new medical technique being used in a number of     clinical studies for diseases such as cancer and cystic fibrosis. At this time, the U.S. Food     and Drug Administration has approved no gene transfer products for commercial use. To date, 8     subjects have received AAV vector in the muscle for a hemophilia B trial by intramuscular     injection, and, to date, 6 subjects have been treated with AAV vector in the current     hemophilia B liver trial. Eleven cystic fibrosis subjects have received AAV vector into their     nasal sinuses or lungs to date. In this study, AAV human Factor IX vector will be injected     into the liver using a catheter inserted into a large blood vessel (called the proper hepatic     artery or the right hepatic artery).   "
171011|NCT00076570|"     This study will test the safety and effectiveness of a combination of three drugs followed by     long-term treatment with just one drug in preventing organ rejection in kidney transplant     patients. Current anti-rejection medicines are not completely effective in preventing     rejection. This trial will test how well Thymoglobulin, Tacrolimus, and Sirolimus work     together post-transplant and if the treatment can be reduced over time to control rejection     with either Tacrolimus or Sirolimus alone.      Candidates for kidney transplantation at the National Institutes of Health Clinical Center     may participate in this 5-year study. Patients will be screened for eligibility with a     medical history, physical examination, and blood tests.      Participants will undergo the following tests and procedures:        -  Central line placement: A large intravenous catheter (plastic tube, or IV line) is          placed in a vein in the chest or neck under local anesthesia before the transplant          surgery. The line remains in place for some time during the hospitalization to          administer Thymoglobulin, antibiotics, and blood, if needed. The line is also used to          collect blood samples.        -  Leukapheresis: This procedure for collecting white blood cells is done before the          transplant. The cells are studied to evaluate the patient's immune system. Whole blood          is withdrawn through a catheter in an arm vein or through the central line and directed          into a machine that separates the blood components by spinning. The white cells are          removed and the red cells and plasma are returned to the body.        -  Kidney transplant: Patients undergo kidney transplant surgery under general anesthesia.        -  Immunosuppressive therapy: Patients receive thymoglobulin by vein for 4 days starting 1          day before the transplant. They also take Tylenol, Benadryl and a steroid          (methylprednisolone) to help reduce the side effects of the Thymoglobulin. After the          transplant, patients receive Tacrolimus and Sirolimus by mouth once a day for 6 months          and then either Tacrolimus or Sirolimus alone indefinitely. In addition, they take          medicines to help prevent viral and fungal infections for 6 months because the          immunosuppressive therapy leaves them vulnerable to infection.        -  Follow-up visits: After hospital discharge, patients return to the Clinical Center twice          a week for 4 weeks, then every 6 months for 1 year, and then yearly for another 4 years.          At each visit, the patient's vital signs are checked and blood and urine samples are          collected. Periodically, patients are also questioned about how they feel and how the          transplant has affected their quality of life. Kidney biopsies (removal of a small          amount of kidney tissue through a thin needle) are done when the patient begins          single-drug immunosuppression (generally 6 months after transplantation) and 1 year          after that. The biopsied tissue is examined to evaluate how well the kidney is          responding to the treatment and to determine how to proceed with therapy.        -  Routine laboratory tests: Routine tests, coordinated by the patient's local physician,          are done 2 to 3 times a week for the first 2 to 3 months after transplantation, then          weekly for several more months, and at least monthly for life.   "
171012|NCT00076583|"     This study will test a spinal cord reflex called reciprocal inhibition before, during, and     after learning a motor skill to see if the reflex becomes stronger by learning the movement.     People learn new motor skills throughout their lives. At first, performing a new skilled     movement such as riding a bicycle takes effort and is clumsy, but with practice, it becomes     relatively automatic. The motor cortex (a part of the brain) is very active when a new     skilled movement is learned, but becomes less active when the movement is over-learned. This     study will determine whether the spinal cord helps coordinate the pattern of activity between     groups of muscles once a motor skill is learned.      Healthy volunteers between 21 and 65 years of age may be eligible for this study. Candidates     are screened with a medical history and neurological examination.      Participants are divided into two groups. Group 1 has movement training sessions only and     Group 2 has both movement training sessions and physiology sessions, as follows:      Movement training sessions      For 15 minutes every weekday, participants practice moving their wrist back and forth to make     a cursor on the computer screen follow a target. Activity of the arm muscles is monitored     with surface electrodes taped to the skin. The sessions continue until the participant can     perform the movement well. Group 1 participants return to the clinic a week after the last     session to perform the movement again to see if their skill level has changed. Each session     lasts about 20 to 30 minutes.      Physiology sessions      In three separate sessions, the reflex for reciprocal inhibition is measured before and at     several times during the movement task. This is done with nerve conduction studies. A probe     placed on the skin delivers a low-intensity electrical stimulus. Wires taped to the skin     record the nerve impulses. To measure reciprocal inhibition, several dozen stimuli are given     to two nerves in combinations. Each session lasts 2 to 3 hours.   "
171013|NCT00076596|"     This study will examine how the brain controls movements in patients with certain types of     cerebral palsy. In healthy people, one side of the body usually controls movements on the     other side of the body. In patients with cerebral palsy, this pattern may be altered, and one     side of the brain may control movements on the same side of the body. Information obtained     from this study may lead to improved rehabilitation therapy strategies for patients with     cerebral palsy.      Healthy volunteers and patients with cerebral palsy between 6 and 18 years of age may be     eligible for this study. All candidates will be screened with a medical history, physical     examination, and psychological testing. In addition, patients with cerebral palsy will have     hearing and vision tests, a review of their medical records, and a magnetic resonance imaging     (MRI) scan if one has not been done within the past year. For this test, the patient lies on     a table that slides into a narrow metal cylinder with a strong magnetic field (the scanner).     The scanning time usually lasts between 45 and 90 minutes.      Patients enrolled in the study also will be evaluated by a physiatrist and physical and     occupational therapists. They will be examined for muscle stiffness and reflexes. Their gait     and movements (e.g., how they pick up a glass of water) will be evaluated. They will be asked     about their ability to perform activities around the house and at school and whether a     wheelchair or walker is needed to get around. Patients may also be asked about how they are     dealing with their movement problems and how it affects their caregivers.      All participants will undergo three tests, described below, to evaluate movement control. The     first two tests use electrodes (small metal discs) taped to the skin over the muscles in both     hands to measure muscle activity. A small disc placed on the fingers detects and measures the     hand movements. The third test uses magnetic pulses that stimulate the brain to study how the     brain controls movements.        1. Quantitative test of fine motor function: For this test, the subject taps buttons at          different speeds on a box attached to a computer. The test is similar to playing simple          computer games.        2. Long latency reflexes: For this test, the subject's hand is lightly strapped into a          holder that holds the hand still while a motor moves the index finger with sudden small          movements. These reflexes may also be tested using a gentle shock to the finger          delivered through a ring electrode.        3. Transcranial magnetic stimulation: For this test, the subject sits in a comfortable          chair. An insulated coil is held on the scalp. A magnetic pulse from the coil stimulates          the brain. The subject may hear a click and feel a snap or pulling sensation on the          scalp under the coil. The stimulation may also cause twitching in the muscles of the arm          or leg. During the stimulation, the subject may be asked to move certain muscles or          perform other simple actions.   "
171014|NCT00076609|"     Capecitabine is a chemotherapeutic that has been approved for use in breast and colorectal     cancers. The advantages of capecitabine are that (1) it is an oral drug; and (2) it is less     toxic than many other chemotherapeutics. In an off-label hepatocellular carcinoma (HCC)     clinical study, the response rate with capecitabine was 13%. The botanical drug     PHY906--currently manufactured pursuant to GMP standards and regulations--has been used in     China for over 1800 years to treat gastrointestinal-related ailments. Recently, preclinical     studies demonstrated that PHY906 potentiates the anti-tumor effect of capecitabine. This     trial will evaluate the safety and efficacy of PHY906 in enhancing the anti-tumor effects of     capecitabine.   "
171015|NCT00076622|"     This study will examine therapeutic and adverse effects of continuing versus discontinuing     antidepressant medication in nursing home residents who have had no more than a single     episode of depression and who no longer have depressive symptoms.   "
171016|NCT00076635|"     Open-label therapy will be administered to up to 220 patients, following completion of either     InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of     subcutaneous Interferon gamma-1b. The study duration will be 5 years.   "
171082|NCT00070681|"     To determine the effects of sleep disorders on cardiovascular function and disease in older     men.   "
171020|NCT00076700|"     This study will determine if the brain regions in blind people that would normally be     involved in vision are used instead to remember touch. Blind people have an enhanced sense of     touch compared to sighted people, and they also perform better on tests for certain kinds of     memory. This study will examine and compare the results of a touch memory test in blind and     sighted people to determine what brain areas are involved in responding to touch.      Blind people and sighted volunteers between 18 and 80 years of age who have no psychiatric     problems or neurological problems (other than blindness) may be eligible for this study.     Candidates are screened with a medical interview and examination.      Participants undergo one or both of the following procedures:      Behavioral experiment      Sighted participants are blindfolded during this experiment. Subjects sit comfortably in     front of a table. They are presented with a number of surfaces placed on a table one at a     time and are given 10 seconds to feel each surface with the index finger on their dominant     hand. They must concentrate and memorize the surfaces as best they can. After a 15-minute     break, they are again presented with a series of surfaces and given 10 seconds to feel each     one. This time, they must say as quickly as possibly whether the surface is one they touched     previously or is a new surface.      Functional MRI      MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues.     In this study, subjects undergo MRI scanning of the brain while performing the same touch     test described above. For the MRI, the subject lies on a table that slides into the scanner.     The MRI machine detects change in the brain regions involved in performing the task.   "
171021|NCT00076713|"     Antiphospholipid Syndrome (APS) is an autoimmune disorder in which the body recognizes     certain normal components of blood and/or cell membranes as foreign substances and produces     antibodies against them. Patients with these antibodies may experience miscarriages and blood     clotting disorders, including heart attacks and strokes. APS may occur in people with     systemic lupus erythematosus and other autoimmune diseases, or in otherwise healthy     individuals.      The Antiphospholipid Syndrome Collaborative Registry (APSCORE) is a national registry and     tissue repository for patients with APS. This registry will collect clinical information and     blood samples from people with APS.   "
171022|NCT00076726|"     The purpose of this study is to evaluate the safety and efficacy (effectiveness) of     Infliximab (Remicade) in patients with Giant Cell Arteritis. Infliximab (Remicade) targets     specific proteins in the body's immune system to help control the development of inflammation     to help reduce painful disease.   "
171023|NCT00076739|"     This study will use magnetic resonance imaging (MRI) to examine which areas of the brain are     involved in performing certain cognitive tasks. MRI uses a strong magnetic field and radio     waves to produce images of body tissues and organs that provide information about structure     and function of tissues.      Healthy normal volunteers between 21 and 40 years of age may be eligible for this study.     Candidates must be native English speakers and must be right-handed. They must have no     history of nervous system disease or psychiatric disorder. Candidates are screened with     questionnaires and a neurological examination.      Participants undergo functional MRI scanning. For this procedure, the subject lies on a     stretcher that moves into the scanner - a metal cylinder surrounded by a strong magnetic     field. During the scan, he or she is asked to make various decisions about whether words are     related or not. Two words are presented visually, separated by a variable time delay. The     subject reads both words, decides as quickly and accurately as possible whether the two words     are related or not, and indicates the answer by pressing a button. The test takes about 2     hours. When it is completed, the subject completes a written questionnaire concerning his or     her experience in the scanner.   "
171024|NCT00076752|"     This study will examine a new approach to treating patients with severe systemic lupus     erythematosus (SLE) that involves collecting stem cells (cells produced by the bone marrow     that develop into blood cells) from the patient, completely shutting down the patient's     immune system, and then giving back the patient's stem cells. SLE is a chronic, inflammatory     disorder of the immune system that can affect many organs. It is called an autoimmune disease     because the patient's lymphocytes (white blood cells that normally protect against invading     organisms), go out of control and attack the body's own tissues.      Patients between 15 and 40 years of age with severe SLE affecting a major organ that is     resistant to standard treatment may be eligible for this study. Candidates are screened with     a medical history and physical examination, blood and urine tests, skin tuberculin test, and     radiology studies to evaluate the extent of disease. They have endocrinology, nutrition,     dental, and social work consultations, ultrasound or MUGA (multi-gated acquisition scan) scan     heart imaging, electrocardiogram and lung function tests, bone marrow biopsy, and lymph node     aspirate. Depending on which organs are affected, patients may have additional tests, such as     lumbar puncture (spinal tap), kidney or lung biopsy, MRI (magnetic resonance imaging) of the     brain and spinal cord, and PET (positron emission tomography) scan. They also complete     quality of life questionnaires and have disability functional testing and neurocognitive     (thinking) assessments.      Participants have a central venous line (plastic tube) inserted into a neck or chest vein for     administering stem cells and medicines and for drawing blood. They undergo seven apheresis     procedures during the course of the study to collect stem cells for transplant and for     research. For apheresis, whole blood is collected through a needle in an arm vein and     directed to a cell-separating machine where the white cells are extracted and the rest of the     blood is returned to the patient through the same needle.      Patients are primed with three medications (methylprednisolone, rituximab, and     cyclophosphamide) through the central line to help control the disease. In addition, a     medication called G-CSF (growth colony stimulating factor) is injected under the skin for     several days to boost production of stem cells. After enough stem cells have been collected     for transplantation (infusion through the central line), patients are admitted to the     hospital for an 8-day conditioning regimen followed by transplantation. The conditioning     treatment consists of rituximab, fludarabine, and cyclophosphamide to eliminate all the white     blood cells from the blood and bone marrow. The stem cells are then infused and the patient     is closely monitored by a team of physicians and nurses. When the stem cells have engrafted,     the bone marrow has recovered, and the patient feels well enough - usually 2 to 3 weeks after     transplant - the patient is discharged from the hospital. Prednisone tapering begins as soon     as feasibly possible, but no later then 28 days after transplant.      Patients return to the National Institutes of Health (NIH) Clinical Center for frequent     follow-up visits during the first 2 to 3 months following transplant. The time between visits     is then extended to once every 3 months the first year, then every 6 months the second year,     and then at least yearly for 5 years after the transplant. These visits include a physical     examination, blood and urine tests, lumbar puncture (if there is central nervous system     involvement), other appropriate biopsies and tests as needed to monitor the patient's health,     short apheresis procedures to collect blood for research purposes, and quality of life     questionnaires. Some select procedures will be optional. Bone marrow biopsies and lymph node     aspirates are done at beginning and at 6, 12, and 24 months after transplant. PET scans are     done at 1, 6, 12, and 24 months.   "
171025|NCT00076791|"     Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal     transmission) become infected during labor and delivery. The purpose of this study is to test     the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or     emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to     their newborn infants.   "
171026|NCT00076804|"     Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These     drug regimens must be closely followed in order to be successful. Having a support person     watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her     regimen. This study will see if patient-chosen treatment supporters help patients take HIV     medicines correctly and improve their health.      Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly     higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm     as compared to the self-administered arm.   "
171027|NCT00076817|"     The purpose of this study is to determine the safety of and immune system response to the     ALVAC-HIV (vCP205) vaccine when it is injected either into the groin area or into the arm.     The goal is to determine if injecting the vaccine into the groin area produces a better     immune response in the lining of the rectum.   "
171028|NCT00076830|"     This study offers evaluation and treatment of patients with a suspected connective tissue     disorder. The protocol is not designed to test new treatments; rather, patients receive     standard care. The study is designed to: 1) allow NICHD's staff to learn more about     connective tissue disorders, 2) train physicians in the evaluation and treatment of these     disorders; and 3) establish a pool of patients who may be eligible for other NICHD protocols     for connective tissue disorders. (Participants in this protocol will not be required to join     another study; the decision will be voluntary.)      Patients of all ages with a suspected connective tissue disorder and their unaffected family     members may be eligible for this study.      Participants undergo diagnostic procedures that may include a medical history, physical     examination, X-ray studies, eye examinations, and blood drawing, as well as other specialized     tests, when needed. Additional tests may include:        -  Blood test for DNA genetic analysis        -  Skin biopsy: Removal of a small piece of tissue for microscopic examination. The area of          skin selected for the biopsy is numbed and a small circle of skin, usually from the          upper arm, is removed with a surgical cookie cutter-like instrument.        -  Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves          to show structural and chemical changes in tissues. The patient lies on a table that          slides into a narrow cylinder containing a magnetic field. Ear plugs are worn to muffle          loud knocking and thumping sounds that occur with electrical switching of the magnetic          fields.        -  Computed tomography (CT) scans: This test allows the doctor to view the organs inside          the body in small sections. The patient lies in a doughnut-like machine. Scanning can be          done from different angles, allowing a three dimensional picture of the part of the body          being studied. It may be done with or without injection of a contrast material.        -  Referral to appropriate sub-specialists when potential complications are found.   "
171093|NCT00070850|"     Smith-Lemli-Opitz Syndrome (SLOS) is a genetic condition that causes mental retardation and     other birth defects. This study will evaluate a new prenatal screening test for SLOS.   "
171029|NCT00076843|"     This study will examine the use of the humanized Mik-Beta-1 (Hu Mik-(SqrRoot) 1) monoclonal     antibody in patients with HTLV-1-associated myelopathy/tropical spastic paraparesis     (HAM/TSP). Some patients infected with the human T-lymphotropic virus type 1 (HTLV-1) virus     develop HAM/TSP, a disease in which the immune response to HTLV-1 becomes directed against     the person's own body in what is called an autoimmune response. Hu-Mik-Beta-1 is a     genetically engineered antibody that blocks the action of a chemical produced by the body     during infection or inflammation called interleukin 15 (IL-15). Blocking IL-15 may prevent     the autoimmune response that results in HAM/TSP.      Patients 18 years of age and older with HAM/TSP may be eligible for this study. Candidates     are screened with a medical history and physical examination, blood and urine tests, and an     electrocardiogram. Participants undergo the following procedures:        1. Baseline visit(s): Repeat physical examination and blood and urine tests, as well as the          following:             -  Lumbar puncture: A local anesthetic is injected to numb the skin of the lower back.               A needle is inserted in the space between the bones where the cerebrospinal fluid               that bathes the brain and spinal cord circulates below the spinal cord. About 4               tablespoons of fluid is collected through the needle.             -  Magnetic resonance imaging (MRI): This test uses radio waves and magnets to produce               images of body tissues and organs. The patient lies on a table that slides into a               metal cylinder surrounded by a strong magnetic field. During part of the scan, a               contrast agent is injected to brighten the images.             -  Apheresis: This procedure is used to collect large quantities of white blood cells.               Whole blood is collected through a needle in an arm vein and directed into a               machine that separates it into its components by spinning. The white cells and               plasma are removed and the rest of the blood (red cells and platelets) is returned               to the body through the same needle.        2. Hu Mik-Beta-1 treatment: Infusions of Hu Mik-Beta-1 are given through a vein every 3          weeks for nine doses. The first treatment requires at least an overnight hospital stay;          subsequent infusions are given in the outpatient clinic.        3. Blood and urine tests and a physical examination at every treatment visit and a skin          test at one treatment visit.        4. Research tests at the end of the 24-week treatment period, including lumbar puncture          (spinal tap), MRI scan, and apheresis.        5. After completing treatment, patients have three follow-up clinic visits for blood and          urine tests, and a skin test at one follow-up visit.   "
171031|NCT00076869|"     Invasive aspergillosis is a type of fungal infection typically identified in very sick     patients (for example, patients with cancer or who have had a bone marrow or organ     transplant). This study will seek to enroll patients (16 years of age or older) with invasive     aspergillosis infections (involving organs or deep tissues) who are failing or could not     tolerate standard antifungal therapy. Your doctor will make this determination based upon     specific study criteria. Patients that fulfill all study criteria will be treated daily with     both the investigational drug and another antifungal agent. The choice of the other agent is     up to your doctor. This investigational drug is approved for the treatment of invasive     aspergillosis by itself. The safety and efficacy of this investigational drug, in combination     with other agents is not known.   "
171032|NCT00076921|"     To characterize the development of tobacco control capacity with staff from the Chinese     Center's for Disease control (CDCs) at the provincial level and to have them develop and     implement population-level interventions to build awareness and knowledge concerning the     harms of smoking that could help lead to policy action being taken to protect the population     from the harms caused by smoking. Compare capacity, policy and, second-hand smoke exposure     and smoking rates in selected provinces to national levels.   "
171033|NCT00076934|"     Multiple sclerosis (MS) is an autoimmune disorder. In this disease, the body's immune system     attacks and destroys the cells that cover and protect nerves. This study will test the safety     of a new drug called RG2077 that is designed to treat MS. The study will not determine     whether RG2077 is effective in treating MS, only whether it is safe to use in patients with     MS.      Study hypothesis: RG2077 will arrest MS if administered early in the course of MS and     decrease accumulation of lesions on MRI.   "
171034|NCT00076947|"     The purpose of this study is to determine the safety of a new HIV vaccine. The vaccine in     this study is mixed with a chemical called alum to improve the body's response to the     vaccine. Healthy adults who are not infected with HIV may participate in the study.   "
171035|NCT00076960|"     The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin]     available to infants who meet the following criteria:        1. the infant has a very high level of bilirubin without an adequate clinical response to          phototherapy;        2. the infant requires an exchange transfusion; and        3. the family refuses to allow the administration of blood products, particularly on          religious grounds, such as within the Jehovah's Witness community.   "
171036|NCT00076973|"     The purpose of this study is to look at whether an investigational drug can treat the     breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.   "
171037|NCT00076986|"     The purpose of the PRECISE trial is to determine whether overall survival duration, safety,     and quality of life are improved for patients treated with IL13-PE38QQR compared to patients     treated with GLIADEL® Wafer following surgical tumor removal in the treatment of first     recurrence of glioblastoma multiforme.   "
171038|NCT00076999|"     The primary objective of this study is to assess the safety and tolerability of tipranavir     (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in     HIV-infected children and adolescents, to provide information concerning the pharmacokinetic     characteristics of tipranavir and ritonavir in this age group, and to determine the relative     bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents     switching from liquid to capsule.      The secondary objective of this study is the determination of the dose of topranavir and     ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an     adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.   "
171039|NCT00077012|"     The primary objective of this study is to assess the safety and tolerance of transurethral     photodynamic therapy (PDT) with QLT0074.      Secondary objectives are:        1. To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign          prostatic hyperplasia (BPH), evaluated by the American Urological Association Symptom          Index (AUA SI), urinary flow rate (Qmax), and post-void residual volume (PVR).        2. To determine the extent of systemic exposure to QLT0074 following transurethral          intraprostatic injection.        3. To select up to two transurethral PDT drug-light regimens for further clinical          development.   "
171040|NCT00077025|"     This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with     Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of     metastatic breast cancer.   "
171094|NCT00070863|"     This study will develop an individual behavior therapy for men who are violent toward their     partners and will compare the therapy to standard group treatment.   "
171041|NCT00077038|"     This study will examine how the brain works when people look at an object, follow a moving     object with their eyes, and reach out their hand to an object. Different areas of the brain     work together in reaching out a hand to an object. These areas are also important for     concentrating on objects or following them with the eyes. This study will use     magnetoencephalography (MEG) to observe more precisely how discrete parts of the brain work     during these movements. MEG is a new technique for recording magnetic field changes produced     by brain activity.      Healthy normal volunteers 20 years of age and older who are right-handed and who have no     history of brain or eye disease may be eligible for this study. Candidates will be screened     with a medical history and brief physical examination. They will complete questionnaires for     MEG screening and for determining handedness.      Participants undergo MEG recording and magnetic resonance imaging (MRI). For MEG, the subject     sits comfortably in front of a computer screen, and a cone containing magnetic field     detectors is lowered onto the head. Electrodes are placed on both sides of the outer part of     the eyelids and just above and below the left eye to monitor eye movement. During MEG,     subjects perform the following tasks:        1. Eye fixation: A small white cross and a white ring appear on the center of the computer          screen. Another white ring moves slowly around the screen in random fashion. Subjects          keep their eyes fixed on the central cross and concentrate on the ring at the center,          ignoring the moving ring.        2. Ocular tracking: The same cross and rings in task 1 appear on the screen, but in this          task the subjects follow the moving ring with their eyes and ignore the cross and ring          in the center.        3. Peripheral manual tracking task (right hand): In addition to the cross and rings in task          1, a small white disc-shaped cursor appears on the screen. Using their right hand,          subjects use a joystick to move the cursor as precisely as possible to follow the moving          ring, while keeping their eyes fixed on the central cross.        4. Peripheral manual tracking task (left hand): The same as task 3, except using the left          hand.        5. Central manual tracking: The cross, rings, and joystick are the same as in task 3.          Subjects move the cursor to follow the moving ring as precisely as possible, while          following the moving ring with their eyes and ignoring the cross and ring in the center          of the screen.      Subjects practice each task before MEG recording starts. Then they perform each task twice in     random order, with a 1- or 2-minute break between tasks.      Subjects who do not have previous MRI images filed in NINDS's database undergo MRI scanning.     MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues.     The scanner is a metal cylinder surrounded by a strong magnetic field. Subjects lie still on     a table that can slide in an out of the cylinder. They can communicate with the MRI staff at     all times during the procedure.   "
171057|NCT00077246|"     RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase I/II trial is studying the side effects and best dose of ABI-007 and to     see how well it works in treating patients with stage IV non-small cell lung cancer.   "
171042|NCT00077051|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosensitizing     drugs, such as cytochlor and tetrahydrouridine, may make tumor cells more sensitive to     radiation therapy. Drugs used in chemotherapy, such as cisplatin work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Combining radiosensitizers with chemotherapy and radiation therapy may kill more     tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of cytochlor when     given together with tetrahydrouridine, cisplatin and radiation therapy in treating patients     with advanced squamous cell carcinoma of the oral cavity (mouth) or oropharynx (throat).   "
171043|NCT00077064|"     RATIONALE: Captopril is a drug that may be able to decrease side effects caused by radiation     therapy, and may improve the quality of life of patients with non-small cell lung cancer or     limited-stage small cell lung cancer.      PURPOSE: This randomized phase II trial is studying how well captopril works in decreasing     side effects and improving the quality of life in patients who have received radiation     therapy with or without chemotherapy for stage I, stage II, or stage IIIB non-small cell lung     cancer or limited-stage small cell lung cancer.   "
171044|NCT00077077|"     RATIONALE: Drugs used in chemotherapy, such as DJ-927 and capecitabine, use different ways to     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may     kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of DJ-927 and     capecitabine in treating patients with locally advanced or metastatic solid tumors.   "
171045|NCT00077090|"     RATIONALE: Hyperbaric oxygen therapy may be effective in repairing damaged tissue and     reducing lymphedema caused by radiation therapy for cancer.      PURPOSE: This randomized phase II trial is studying hyperbaric oxygen to see how well it     works compared to standard therapy in treating chronic arm lymphedema in patients who have     undergone radiation therapy for cancer.   "
171046|NCT00077103|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cisplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Combretastatin A4 phosphate may stop the growth of     cancer by stopping blood flow to the tumor. Combining doxorubicin and cisplatin with     radiation therapy and combretastatin A4 phosphate may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving induction chemotherapy using     doxorubicin and cisplatin together with radiation therapy and combretastatin A4 phosphate     works in treating patients with newly diagnosed regionally advanced anaplastic thyroid     cancer.   "
171047|NCT00077116|"     RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different     ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies,     such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Giving monoclonal antibody     therapy together with chemotherapy may kill more cancer cells. Giving healthy stem cells from     a donor whose blood closely resembles the patient's blood will help the patient's bone marrow     make new stem cells that become red blood cells, white blood cells, and platelets.      PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together     with gemtuzumab ozogamicin works in treating patients with previously untreated high-risk     myelodysplastic syndrome or acute myeloid leukemia secondary to myelodysplastic syndrome.   "
171048|NCT00077129|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin     works in treating patients with locally advanced or metastatic collecting duct renal cell     cancer that cannot be removed by surgery.   "
171049|NCT00077142|"     RATIONALE: TAC-101 may stop the growth of cancer by stopping blood flow to the tumor.      PURPOSE: This phase I/II trial is studying the side effects and best dose of TAC-101 and to     see how well it works in treating patients with advanced hepatocellular carcinoma (liver     cancer).   "
171050|NCT00077155|"     This phase I trial is studying the side effects and best dose of EMD 121974 in treating     patients with solid tumors or lymphoma. Cilengitide (EMD 121974) may stop the growth of     cancer cells by stopping blood flow to the cancer   "
171051|NCT00077168|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known whether radiation therapy after surgery is effective in preventing a recurrence of     ductal carcinoma in situ.      PURPOSE: This randomized phase II trial is studying adjuvant radiation therapy to see how     well it works compared to observation after surgery in treating women with estrogen receptor     positive or progesterone receptor positive ductal carcinoma in situ and are also receiving     either tamoxifen or anastrozole.   "
171054|NCT00077207|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, and temozolomide,     work in different ways to stop tumor cells from dividing so they stop growing or die. Giving     more than one drug may kill more tumor cells.      PURPOSE: This pilot study is studying giving carboplatin and vincristine together with     temozolomide in treating children with progressive and/or symptomatic low-grade glioma.   "
171055|NCT00077220|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. It is not yet known whether giving chemotherapy     together with radiation therapy is more effective with or without adjuvant chemotherapy in     treating unresectable stage II or stage III non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying giving paclitaxel, carboplatin, and     radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works     compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients     with unresectable stage II or stage III non-small cell lung cancer.   "
171056|NCT00077233|"     This is a randomized phase II study trial that has served as a screening trial to test the     increased efficacy of chemotherapy + cetuximab versus chemotherapy alone among patients with     untreated, advanced or metastatic colon cancer regardless of tumor status with respect to     EGFR.   "
171120|NCT00071201|"     This is a multi-center phase 3, open-label, parallel-group study designed to evaluate the     efficacy, safety and pharmacokinetics of adefovir dipivoxil liquid suspension in patients     with chronic hepatitis B and varying degrees of renal impairment.   "
171058|NCT00077259|"     RATIONALE: Drugs used in chemotherapy such as epothilone D work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well epothilone D works as second-line therapy     in treating patients with advanced or metastatic refractory colorectal cancer.   "
171059|NCT00077285|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin     as upfront window therapy (first-line therapy) works in treating patients with newly     diagnosed intermediate-risk or high-risk rhabdomyosarcoma.   "
171060|NCT00077298|"     This randomized phase II trial is studying giving bevacizumab and cetuximab together with     irinotecan to see how well it works compared to giving bevacizumab and cetuximab alone in     treating patients with irinotecan-refractory metastatic colorectal cancer. Monoclonal     antibodies such as cetuximab and bevacizumab can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or deliver tumor -killing substances to them. Drugs used in chemotherapy, such as     irinotecan, also work in different ways to kill tumor cells or stop them from growing. Giving     cetuximab and bevacizumab together with irinotecan may improve the ability to block tumor     growth.   "
171061|NCT00077311|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs,     such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and     inner ear damage) caused by chemotherapy.      PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together     with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in     treating patients with stage IIIB or stage IV non-small cell lung cancer.   "
171062|NCT00077324|"     RATIONALE: Evaluating specific proteins in the blood may be an effective and noninvasive     procedure to help doctors determine if a patient has early non-small cell lung cancer.      PURPOSE: This clinical trial is studying proteomic profiling to see how well it works in     diagnosing non-small cell lung cancer in patients who are undergoing resection for suspicious     (abnormal) stage I lung lesions.   "
171063|NCT00077337|"     RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with     unresectable locally advanced or metastatic colorectal cancer.   "
171064|NCT00077350|"     Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop     tumor cells from dividing so they stop growing or die. Giving 3-AP together with gemcitabine     may kill more tumor cells. This phase II trial is studying how well giving 3-AP together with     gemcitabine works as second-line therapy in treating patients with progressive or recurrent     non-small cell lung cancer   "
171065|NCT00077363|"     This phase II trial is studying how well giving capecitabine together with tipifarnib works     in treating women with taxane-resistant metastatic breast cancer. Drugs used in chemotherapy,     such as capecitabine, work in different ways to stop tumor cells from dividing so they stop     growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes     necessary for their growth. Giving capecitabine together with tipifarnib may kill more tumor     cells   "
171066|NCT00077376|"     This phase II trial is studying how well giving trastuzumab together with ixabepilone and     carboplatin works in treating patients with HER2/neu-positive metastatic breast cancer.     Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy, such as ixabepilone and carboplatin, work in different ways to stop tumor cells     from dividing so they stop growing or die. Combining trastuzumab with ixabepilone and     carboplatin may kill more tumor cells.   "
171067|NCT00077389|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the     tumor so that it can be removed.      PURPOSE: This phase II trial is studying how well neoadjuvant chemotherapy works in treating     young patients who are undergoing surgical resection for high-risk hepatoblastoma.   "
171068|NCT00077402|"     RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well fenretinide works in treating patients with     advanced or metastatic hormone-refractory prostate cancer.   "
171069|NCT00077415|"     RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways     to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine as     second-line therapy works in treating patients with recurrent stage III or stage IV non-small     cell lung cancer.   "
171070|NCT00077428|"     This phase II trial is studying how well bortezomib followed by doxorubicin at the time of     disease progression works in treating patients with locally advanced, recurrent, or     metastatic adenoid cystic carcinoma (cancer) of the head and neck. Bortezomib may stop the     growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in     chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing     so they stop growing or die. Combining bortezomib with doxorubicin may kill more tumor cells   "
171071|NCT00077441|"     This phase II trial is studying how well bortezomib works in treating patients with     hepatocellular carcinoma (liver cancer) that cannot be removed with surgery. Bortezomib may     stop the growth of tumor cells by blocking the enzymes necessary for their growth.   "
171072|NCT00070538|"     RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, use different ways     to stop cancer cells from dividing so they stop growing or die. Combining more than one drug     may kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in     treating patients who have hematologic malignancies, including myelodysplastic syndrome or     relapsed, refractory, or untreated leukemia.   "
171121|NCT00071214|"     Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic     hemodialysis patients against infection by Staphylococcus aureus.   "
171122|NCT00071227|"     This study will evaluate the safety and effectiveness of a new formulation of triamcinolone     acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid     drug that decreases inflammation and scarring and is routinely used to treat eye inflammation     or swelling. The commercially available form of this drug is associated with potentially     harmful side effects thought to be due to preservatives in the preparation. This study will     use a formulation that does not contain these potentially harmful preservatives. Preliminary     findings from other studies suggest that injection of steroids in the eye can reduce retinal     thickening and improve vision. However, they may also cause mild discomfort and lead to     vision-threatening conditions. The effects of the drug on the conditions under study in this     protocol are not known.      Patients with the following conditions involving disorders of retinal blood vessels may be     eligible for this study:        -  Choroidal neovascularization associated with age-related macular degeneration (50 years          of age and older)        -  Macular edema associated with retinal vein occlusion (18 years of age and older)        -  Diabetic macular edema ((18 years of age and older)      Participants undergo the following tests and procedures:        -  Medical history and physical examination        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to          examine pupils, lens, retina and eye movements. The pupils will be dilated with drops          for this examination.        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina          are taken using a camera that flashes a blue light into the eye. The pictures show if          any dye has leaked from the vessels into the retina, indicating possible blood vessel          abnormality.        -  Indocyanine green angiography to identify feeder vessels that may be supplying abnormal          blood vessels. This procedure is similar to fluorescein angiography, but uses a green          dye and flashes an invisible light.        -  Optical coherence tomography to measure retinal thickness. This test shines a light into          the eye and produces cross-sectional pictures of the retina. These measurements are          repeated during the study to determine if retinal thickening is getting better or worse,          or staying the same.        -  Stereoscopic color fundus photography to examine the back of the eye. The pupils are          dilated with eye drops to allow examination and photography of the back of the eye.        -  Triamcinolone acetonide injection to treat the eye. A numbing eye drop, an antibiotic          eye drop, and an injected antibiotic are put in the eye before triamcinolone acetonide          is injected into the eye's vitreous (jelly-like substance inside the eye). After the          injection, the patient lies on his or her back for 30 minutes. An antibiotic eye          ointment is used for 2 days following treatment.        -  Blood tests to measure liver and kidney function.      Patients return to the clinic for follow-up visits 1, 4, and 7 days, and 1 month after the     first treatment. Patients whose condition does not improve after 3 months do not receive any     more injections, but return for eye examinations at least once a year for 3 years. Patients     whose condition improves with treatment return for follow-up visits 6 and 9 months after the     first injection and then every 6 months for 2 more years. At each visit, a determination is     made whether another injection is needed. After each repeat injection, patients return for     follow-up visits at 1, 4, and 7 days after the injection.   "
171073|NCT00070551|"     This phase I trial is studying the side effects and best dose of GTI-2040 and high-dose     cytarabine in treating patients with refractory or relapsed acute myeloid leukemia. GTI-2040     may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.     Drugs used in chemotherapy, such as cytarabine, use different ways to stop cancer cells from     dividing so they stop growing or die. Giving GTI-2040 together with cytarabine may kill more     cancer cells.   "
171074|NCT00070564|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel,     use different ways to stop tumor cells from dividing so they stop growing or die. Combining     more than one drug and giving them after surgery may kill any remaining tumor cells. It is     not yet known which combination chemotherapy regimen is more effective in treating resected     breast cancer.      PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination     chemotherapy to see how well they work in treating patients who have undergone surgery for     stage I, stage II, or stage III breast cancer.   "
171075|NCT00070577|"     This study will examine age and sex differences in alcohol metabolism and the effects of     alcohol. Men and women differ in their ability to metabolize alcohol, possibly due to     differences between men and women in lean body mass, liver size, or the activity of enzymes     that act on alcohol in the liver. Also, older men and women are thought to be more sensitive     to alcohol, although the reasons for this are not clear.      Healthy men and women between 21 and 25 years of age and between 55 and 65 years of age who     are social drinkers may be eligible for this study. Candidates will be screened with     questionnaires about their general and mental health, alcohol use, and family history of     alcohol use and problems. They will have a physical examination, electrocardiogram (EKG),     routine blood tests, urinalysis to test for drugs of abuse, and a blood test to study the     gene responsible for enzymes that metabolize alcohol. Younger women will have a urine     pregnancy test and older women will have a test to confirm post-menopausal status.      Participants will have two study sessions at the NIH Clinical Center outpatient clinic. They     come to the clinic by taxi and, upon arrival, take a breathalyzer test for any measurable     alcohol levels. They are then given breakfast, after which two catheters (plastic tubes) are     placed, one in a vein in each arm. One tube is used to collect blood samples for measuring     hormone levels; the other is for infusing alcohol. The infusion is adjusted so that the     breath alcohol level is held constant for about 3 hours at a moderate level. Baseline     measurements are taken before the infusion begins. During and after the infusion, the     participants fill out questionnaires about their moods and feelings. Breath alcohol level and     heart rate measurements are monitored frequently. After the test, participants remain in the     clinic until their breath alcohol level drops below 0.02 g/L (generally 2 to 3 hours after     the infusion stops). They are given lunch and then sent home in a taxi.      Participants also undergo a dual energy x-ray absorptiometry (DEXA) scan to determine lean     body mass and a magnetic resonance imaging (MRI) scan of the abdomen to determine liver size.     For the DEXA scan, the subject lies still on a table for about 30 minutes while the whole     body is scanned using a small amount of radiation. For the MRI, the subject lies in a narrow     metal cylinder (the scanner) about 30 minutes for the scan.   "
171076|NCT00070590|"     Clinical and experimental studies suggest that bosentan could delay the progression of     interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for     which no established efficacious treatment is available. The present trial investigates a     possible use of oral bosentan, which is currently approved for the treatment of symptoms of     pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients     suffering from ILD associated with SSc.   "
171077|NCT00070616|"     Open label palifermin will be administered to subjects who are at a risk of developing     mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount     of palifermin in the blood following administration will be evaluated. The safety of     palifermin administration and its effect on reducing mucositis will also be evaluated.   "
171078|NCT00070629|"     Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a     taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol     therapy will be administered until disease progression or intolerable toxicity. CpG 7909     Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle     (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will     undergo complete disease evaluation at the end of every other treatment cycle until disease     progression.   "
171079|NCT00070642|"     To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given     with chemotherapy to patients with melanoma.   "
171080|NCT00070655|"     This trial will include patients who have a heart condition called atrial fibrillation.     Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial     fibrillation have an increased chance for a blood clot to form in the heart and move to other     blood vessels in the body and cause obstruction. This obstruction may damage tissue. For     example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore,     patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as     warfarin or acenocoumarol.      The purpose of this study is to compare the safety and effectiveness of a new injectable     anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol     tablets.      Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol)     tablets will be purely by chance and will be known by both patients and their doctors.   "
171081|NCT00070668|"     To investigate the relationship between genetic variation in genes for inflammation and     carotid artery atherosclerosis.   "
171083|NCT00070694|"     This study will examine whether a highly specific and powerful 5-hydroxytryptamine 2A     (5-HT2A) antagonist, M100907, combined with escitalopram, is responsible for an     antidepressant effect. Major affective disorders are common and can be chronic and life     threatening. Yet as many as 50 to 75 percent of patients get only a partial response to the     use of antidepressants. Some do not respond to medications in the category of serotonin     reuptake inhibitors (SSRIs)-or they experience side effects that sharply interfere with daily     life. This study will determine the extent to which M100907 improves sleep and improves     fatigue in people who are treated, and how it reduces cognitive impairment, that is,     limitations to awareness, in the depressive syndrome. It will also look at allele frequencies     as being covariates in the analysis and to collect data.      Patients 18 to 65 years of age who meet the criteria for major depression, without psychotic     features, may be eligible for this study. Women of childbearing potential must be using two     medically accepted contraception methods and must agree to a (Beta)-HCG (human chorionic     gonadotropin, a polypeptide hormone produced by the human placenta) test at the screening and     at several intervals.      In random groups, participants will receive treatment with escitalopram and either M100907 or     a placebo. The timing of escitalopram can be adjusted to manage side effects. If already     taking any other medications for psychiatric purposes, participants will be tapered from     those medications and monitored.      Participants will also undergo the following tests and procedures:        -  Test of vital signs, lying and standing        -  Physical exam        -  12-lead electrocardiogram (SCG)        -  Psychiatric examination for screening        -  Thyroid screening        -  Collection of blood for chemistry and hematology        -  Hepatitis B and C/HIV screening        -  Beta-HCG pregnancy test, if applicable        -  Urine drug screening        -  Urinalysis        -  Tests using the Hamilton Depression Rating Scale and the Montgomery-Asburg Depression          Rating Scale        -  Use of the Antidepressant Treatment History      A sleep study will be conducted during the steady state period and again toward the end of     the double blind treatment period. Each study will involve 2 consecutive nights of     polysomnographic recording done by an EEG technologist experienced in using the technique.   "
171084|NCT00070707|"     An association between seasonal allergic rhinitis (SAR) and allergic asthma has been     established through epidemiologic, pathophysiologic, and therapeutic studies. This study will     compare Nasonex Nasal Spray to Placebo in treating the nasal and asthma symptoms experienced     by subjects with SAR and concomitant asthma.   "
171085|NCT00070720|"     Many obstetrical interventions used in Latin America, as in other parts of the world, have     been shown to be ineffective or harmful, while effective interventions remain underutilized.     This study will develop and evaluate an intervention intended to implement two evidence-based     practices among birth attendants in Latin America, the selective use of episiotomies and     active management of the third stage of labor.   "
171086|NCT00070733|"     The enzyme 5-alpha reductase is present in small amounts in muscle and converts testosterone     to dihydrotestosterone (DHT). Testosterone affects lean body tissue, muscle size, muscle     strength, and sexual function in men. This study will evaluate how 5-alpha reductase     influences the effects of testosterone in young healthy men.   "
171087|NCT00070746|"     There are large differences in health outcomes related to pregnancy and birth between     developed and developing countries. This study will investigate how infections, medical     history, health care behavior and psychosocial issues are associated with pregnancy outcomes     in Pakistan.   "
171088|NCT00070759|"     This study will examine the safety and effectiveness of treating uveitis, an eye     inflammation, with a monoclonal antibody called daclizumab. Monoclonal antibodies are     genetically engineered proteins made in large quantities and directed against a specific     target in the body. Daclizumab is designed to prevent a specific chemical interaction needed     for immune cells called lymphocytes to produce inflammation. In an ongoing NIH study of 10     adults with uveitis, 8 patients were able to decrease corticosteroids and other     immunosuppressive medicines they were taking while receiving daclizumab for months or even     years. Seven patients continue to take the drug.      Patients 18 years of age and older with active non-infectious intermediate or posterior     uveitis in both eyes who require treatment for their disease may be eligible for this study.     Candidates will be screened with the following tests and procedures:        -  Medical history and physical examination.        -  Eye examination to measure visual acuity and eye pressure, and examine the lens, retina,          pupils and eye movements.        -  Blood tests to measure the number and types of blood cells.        -  Fluorescein angiography to check for abnormalities of eye blood vessels. A yellow dye          injected into an arm vein travels to the blood vessels in the eyes. Pictures of the          retina are taken with a special camera that flashes a blue light into the eye. The          pictures show if any dye has leaked from the vessels into the retina, indicating          possible abnormalities.      Participants come to the NIH Clinical Center for treatment and follow-up visits. The first     daclizumab treatment is given as a 90-minute infusion through a vein. A second IV infusion is     given 7 days later. If the treatment has successfully reduced the eye inflammation after 2     weeks, then subsequent treatments are given through injections under the skin once a month     for up to 1 year. Patients whose eye disease is not improved after 2 weeks stop the study     treatments and receive alternative therapy.      Follow-up visits are scheduled 7, 14, and 21 days after enrollment and at each treatment     visit to evaluate the response to treatment and drug side effects. During these visits,     patients repeat the exams done at screening. Extra blood samples are taken at certain visits     to measure blood levels of daclizumab and to perform clinical laboratory and immunology     tests. Fluorescein angiography is done at enrollment and after 1 year.   "
171089|NCT00070785|"     This study will evaluate the ability of people of different ethnic backgrounds to develop     immune responses against the Epstein-Barr virus (EBV). A common virus, EBV is present in 90     percent of healthy people and usually does not cause problems. Most people are infected in     childhood, have no symptoms, and are unaware of their infection. People infected as     adolescents or adults may develop infectious mononucleosis, which usually resolves     completely. However, in immune suppressed people, like those who have had a transplant, EBV     can cause fatal cancers. It can also cause certain cancers such as Burkitt's lymphoma,     Hodgkin's lymphoma, and nasopharyngeal carcinoma in people who are not immune suppressed.     Nasopharyngeal carcinoma is 100 times more common in people of Asian origin (particularly     southern Chinese) compared with Caucasians. This difference may be the result of genetic,     rather than environmental, factors. This study will examine whether the same proteins     produced by EBV in the cancer cells react differently in people of different ethnic     background in a way that could explain the differences in predisposition for this disease.      Healthy normal volunteers 18 years of age and older of Caucasian or Chinese ancestry may be     eligible for this study. Candidates of Chinese ancestry must be born in China (including     Taiwan, Hong Kong, and Singapore, or be first generation offspring of parents born in these     places).      Participants will have a blood sample drawn and will undergo lymphapheresis - a procedure for     collecting large numbers of white blood cells called lymphocytes. The blood sample is tested     for blood counts and HLA type, a genetic marker of the immune system. HLA molecules help     determine the way the body's immune cells respond to virus. HLA typing is similar to blood     typing. Usually done to match stem cell or organ transplants, HLA testing may also be used to     try to identify factors associated with an increased risk of certain diseases or conditions.     HLA type is strongly associated with ethnic background.      For lymphapheresis, blood is collected through a needle in an arm vein, similar to donating     blood. The blood flows from the vein through a catheter (plastic tube) into a machine that     separates it into its components by centrifugation (spinning). The white cells are removed     and the rest of the blood (red cells, plasma and platelets) is returned to the body through a     needle in the other arm. The procedure takes 2 to 3 hours. The collected white cells are used     for research for this study, including the ability to react to EBV proteins, and are then     destroyed.   "
171090|NCT00070811|"     The purpose of this study is to determine whether secondary (revision) surgery to the lip in     patients with cleft lip and palate is effective in improving lip function and appearance.   "
171091|NCT00070824|"     The goal of this study is to use single photon emission computed tomography (SPECT) and     functional magnetic resonance imaging (f-MRI) of the brain to study the response of both     normal participants and participants with Osteoarthritis (OA) of the knee to acupuncture.   "
171092|NCT00070837|"     The purpose of the study is to determine the highest dose of MLN2704 that can be given     multiple times safely to patients with prostate cancer, and to identify any side effects     associated with taking the drug. This study will also evaluate how MLN2704 is taken up,     broken down and eliminated by the body.   "
171096|NCT00070889|"     Patients experiencing a first episode of psychosis may have brain cell damage due to a     chemical process called oxidation. This study will compare patients with psychosis to healthy     volunteers to determine if there are differences in their blood that reflect oxidative brain     cell damage.   "
171097|NCT00070902|"     Lumbar spinal manipulation, or chiropractic adjusting, is thought to separate the surfaces of     the spinal joints and thereby relieve lower back pain. This study will use MRI scans to     evaluate the spinal joints before and after spinal manipulation.   "
171098|NCT00070915|"     This clinical trial is a preliminary study designed to prepare for a full-scale, randomized     clinical trial of the effectiveness of tai chi, mediation, and therapeutic massage for     chronic lower back pain in adults.   "
171099|NCT00070928|"     The purpose of this trial is to test the short-term effectiveness of valerian, a medicinal     herb, to improve sleep in patients with Parkinson's disease (PD).   "
171100|NCT00070941|"     This study will test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of     depression in patients with Parkinson's disease (PD).   "
171156|NCT00077727|"     The purpose of this study is to determine if adding extended-release galantamine     hydrobromide, compared with adding placebo, to current atypical antipsychotic therapy is well     tolerated and effective in improving cognitive impairment in patients with schizophrenia.   "
171101|NCT00070954|"     Electroconvulsive therapy (ECT) is an effective treatment for severe or medication-resistant     depression and other psychiatric disorders. A common side effect of ECT is problems with     short-term memory during treatment. This study will test whether taking ginkgo biloba (GB)     prior to and during the course of ECT will lessen the effects of ECT on short-term memory.   "
171102|NCT00070967|"     This study will test the feasibility of acupuncture as a complementary therapy for advanced     cancer by comparing symptoms and quality of life before and after 8 weeks of acupuncture     treatments.   "
171103|NCT00070980|"     The purpose of this study is to determine whether massage therapy can improve immune status     and enhance well-being in children living in the Dominican Republic who are infected with     HIV.   "
171104|NCT00070993|"     Creatine is a naturally occurring chemical involved in the production of energy in muscle.     Abnormalities in creatine have been linked to the progression of degenerative neuromuscular     diseases such as amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). This study     will test whether taking creatine can improve the symptoms of ALS.   "
171105|NCT00071006|"     The study tests the safety and efficacy of axitinib in patients who have the hematologic     disease of Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study tests patients who     have poor prognosis before entering the study.   "
171106|NCT00071019|"     To examine the relationship between genetic and dietary factors that modify the risk of     coronary heart disease (CHD).   "
171107|NCT00071032|"     The purpose of this study is to compare liberal red blood cell transfusion therapy with     restrictive red blood cell transfusion therapy in surgical patients with cardiovascular     disease or risk factors.   "
171108|NCT00071045|"     This study will collect biological samples for use in research experiments aimed at better     understanding the clinical features of certain diseases. The specimens may be used to     evaluate the effectiveness of known therapies, refine treatment approaches, identify     potential new therapies, and explore opportunities for disease prevention.      The following individuals 2 years of age or older may be eligible for this study:        -  Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder who          are being screened for or who are enrolled in a treatment study at the NIH Clinical          Center        -  HLA-compatible donor family members (18 years of age or older) of the above patients who          are being evaluated for or are enrolled in an NIH study as a stem cell transplant donor        -  Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder or          a bone marrow failure condition who cannot participate in an NIH treatment protocol or          travel to the NIH Clinical Center and who are referred for participation through their          home health care provider.      Research samples will be collected from participants when blood is drawn or bone marrow,     urine, or stool is collected, or tumor or other tissue is biopsied as part of their general     medical care. Investigators may periodically request an additional sample of blood, stool, or     urine. Participants who are 18 years of age or older may donate a large number of white blood     cells through a procedure called leukapheresis. This procedure is not part of general medical     care and would be done for research purposes only. For apheresis, a catheter (plastic tube)     is placed in a vein in the subject's arm. Blood flows from the vein into a cell separator     machine, where the white cells are separated from the red cells, platelets, and plasma by a     spinning process. The white cells are removed and collected, and the rest of the blood is     returned to the subject through a second tube placed in the other arm.   "
171109|NCT00071058|"     This study will examine the safety and effectiveness of treating adrenocortical cancer with     combination chemotherapy using doxorubicin, vincristine, and etoposide in addition to the     drugs mitotane and tariquidar and, when possible, surgery. Adrenocortical cancer cells have a     large amount of a protein called P-glycoprotein that pumps anti-cancer drugs out of the     cells, decreasing their effectiveness. Continuous infusions of doxorubicin, vincristine, and     etoposide may improve chemotherapy results by blocking the P-glycoprotein pump, as may use of     tariquidar, an experimental drug that is known to block the P-glycoprotein pump.      Patients 18 years of age and older with adrenocortical cancer that has recurred, spread, or     cannot be treated surgically may be eligible for this study. Candidates will be screened with     a medical history and physical examination; review of pathology slides; blood tests;     electrocardiogram (EKG); imaging tests, including computed tomography (CT) of the chest,     abdomen and pelvis; chest x-ray; and possibly a bone scan or other imaging tests needed to     evaluate the cancer, urine studies, and an echocardiogram. Also, a biopsy (removal of a small     sample of tumor tissue) may be required if a specimen is not available to confirm the cancer.      Participants will undergo the following tests and procedures:        -  Tumor biopsy. Before starting chemotherapy, a small piece of tumor is removed to study          the P-glycoprotein pump and to determine the tumor genetics.        -  Blood draw. Blood is drawn before treatment begins to establish baseline levels for          future blood tests.        -  Central venous catheter placement. A specially trained physician places a plastic tube          into a major vein in the chest. The tube is used to give the study drugs and other          medications and to withdraw blood samples. It can stay in the body for months or be          removed after each treatment is completed. The tube placement is done under a local          anesthetic in the radiology department or operating room.        -  Chemotherapy. Treatment cycles are 21 days. Doxorubicin, vincristine, and etoposide are          given through the central venous catheter by an infusion pump continuously over 96 hours          starting day 1 of each cycle. The dose of these drugs may be increased or decreased from          cycle to cycle, based on side effects. Mitotane is given in pill form starting day 1 of          cycle 1 and is taken every day throughout the entire study. The mitotane dose is          gradually increased as long as the side effects are tolerable. Tariquidar is given          through the central venous catheter as a 30-minute infusion on days 1 and 3 of every          cycle. The tariquidar dose remains the same throughout the study. Treatment will          continue for two cycles after all the cancer is gone, or until surgery is done to remove          some or all of the remaining cancer, or, if surgery is not an option, until the cancer          has grown to where it is defined as progressive disease.        -  Nuclear scans. A nuclear scan is done before treatment begins and again on day 1 or day          3 of the first treatment cycle after administration of tariquidar to evaluate the P          glycoprotein response to treatment.        -  Computed tomography (CT) scans. These scans are done every two treatment cycles to          follow disease progress.        -  Surgery. Surgery to remove areas of cancer may be considered at any point during the          study (including before beginning treatment), if it is deemed beneficial. Treatment with          the study drugs will begin or resume after surgery. The length of treatment will depend          on the response to treatment before the surgery and on whether there is any cancer          remaining after the surgery.   "
171110|NCT00071071|"     The purpose of this trial is to determine the effect of HuMax-CD4 as a treatment for early     stage cutaneous T-cell lymphoma (CTCL). Almost all patients who are affected by CTCL have     cancerous cells which bear a receptor called CD4. HuMax-CD4 is an investigational drug     directed against this receptor. There is no placebo in this trial; all patients will be     treated with HuMax-CD4. During the trial, the response rates, duration of responses, relief     of symptoms, and safety profile of HuMax-CD4 will be evaluated.   "
171111|NCT00071084|"     The purpose of this trial is to determine the effect of HuMax-CD4, as a treatment for     advanced stage (late stage) cutaneous T-cell lymphoma (CTCL). Almost all patients who are     affected by late stage CTCL have many cancerous cells which bear a receptor called CD4.     HuMax-CD4 is an investigational drug directed against this receptor. There is no placebo in     this trial; all patients will be treated with HuMax-CD4. The response rates, duration of     responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated during this     trial.   "
171112|NCT00071097|"     The purpose of this study is to determine the effectiveness, safety, and tolerability (how     well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114     given with low dose ritonavir.   "
171113|NCT00071110|"     This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and     sham electroacupuncture (SA) for the treatment of major depression.   "
171114|NCT00071123|"     This study will evaluate emotional processing biases in the brain while viewing facial     expressions in adults with current or remitted major depressive disorder and healthy     volunteers.   "
171115|NCT00071136|"     This is a Phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days     to patients with advanced stage non-small cell lung cancer. This treatment is for patients     that have not received any prior chemotherapy treatment for lung cancer. The primary goal is     to find out if the tumor gets smaller or disappears with this treatment.   "
171116|NCT00071149|"     Practitioners of Traditional Chinese Medicine (TCM) make diagnoses based solely on clinical     symptoms. This study will evaluate whether TCM practitioners make diagnoses consistently.   "
171117|NCT00071162|"     The Fibromyalgia Family Study identifies and collects blood samples from families with two or     more members affected with Fibromyalgia Syndrome (FMS). The primary goal of the study is to     identify genes that predispose people to FMS and/or symptoms related to FMS; identifying     these genes may lead to a better understanding of the disease and more effective treatments.   "
171118|NCT00071175|"     The Lupus Genetics Studies and Lupus Family Registry & Repository are working to find the     genes that reveal the causes of systemic lupus erythematosus (SLE, or lupus). The study is     enrolling families of all ethnic backgrounds from the United States, Canada, Puerto Rico, and     the Virgin Islands that have one or more living members diagnosed with SLE.   "
171119|NCT00071188|"     The purpose of the run-in phase of this study is to determine the appropriate and tolerable     dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and     carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This     phase of the trial is closed to enrollment.      The purpose of the randomized phase of this study is to determine the efficacy of ZD6474     alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of     paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or     metastatic NSCLC. This phase of the trial is closed to enrollment.   "
171123|NCT00071240|"     Growth hormone plays an important role in the development of the immune system. Studies     suggest that growth hormone may promote growth of the thymus, a gland responsible for the     production of important immune cells called T cells. Since these cells are lost during the     course of HIV infection, it is possible that growth hormone treatment could help restore the     immune system. This study will determine whether the administration of growth hormone can     increase the size and function of the thymus and cause an increase in the number of new T     cells in the blood of people infected with HIV.      Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected     adults.   "
171124|NCT00071253|"     The purpose of this study is to assess the efficacy and safety of continued combination     therapy using Depakote plus olanzapine, vs. Depakote monotherapy and olanzapine monotherapy     in stable subjects during the maintenance phase of bipolar illness.   "
171125|NCT00071266|"     The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin,     Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of     their leg arteries.      At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take     part in this study.      Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug     Administration (FDA) to treat high cholesterol. Niacin ER/Lovastatin (Advicor®), a     combination of these two drugs, is also approved by the FDA to treat high cholesterol. The     use of Niacin ER/Lovastatin to treat narrowing of leg arteries and relieve “intermittent     claudication” (leg pain caused by narrowing of the arteries in the leg) is considered     investigational. An investigational use is one that is not approved by the FDA.   "
171126|NCT00071279|"     Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis     (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant     (blood-thinning) drugs are normally given immediately after the clot is discovered and are     continued for a period of 3 or 6 months during which time the risk for recurrence is highest.     Research has shown that when oral anticoagulants are used appropriately during this period,     patients are less at risk for a recurrent blood clot and this risk reduction outweighs the     potential for bleeding to occur.      In this study, patients who had a blood clot in the lung or in a leg vein and completed 6     months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or     once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6     months of once-weekly SR34006 injections or injections of a solution containing no drug     (placebo). This trial will evaluate whether patients treated for an additional 6 months with     SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.      Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor     their doctors will know which treatment is being given.   "
171127|NCT00071292|"     The purpose of this study is to determine whether a mindfulness meditation-based stress     reduction program is useful in relieving symptoms associated with rheumatoid arthritis (RA).   "
171128|NCT00071305|"     This study will evaluate the magnetoencephalography (MEG) alone and together with     electroencephalography (EEG) in non-invasive presurgical evaluation. It will look at the     contribution of those methods in determining the location of the epilepsy seizure, compared     with doing so through an invasive method. EEG measures electronic potential differences on     the scalp. On the other hand, MEG is a non-invasive technique for recording the activity of     neurons in the brain, through recording of magnetic fields caused by synchronized neural     currents. It has the ability to detect seizures. Because magnetic signals of the brain vary,     this technique must balance two key problems: weakness of the signal and strength of the     noise. The EEG is sensitive to extra-cellular volume currents, whereas the MEG primarily     registers intra-cellular currents. Because electrical fields are quite dependent on the     conductive properties of the tissues, and magnetic fields are significantly less distorted by     tissue, the MEG has better spatial resolution. There is a great deal of evidence that EEG and     MEG provide complementary data about underlying currents of ions.      Patients 18 years of age or older who have epilepsy that is not relieved, and who are     considered candidates for surgery and who accept epilepsy surgery, may be eligible for this     study.      Before they have surgery, participants will either sit or lie down, with their head in a     helmet covering the entire head, with openings for the eyes and ears. Brain magnetic fields     will be recorded with a 275-channel OMEGA system. Throughout the session, visual and two-way     audio communication will be maintained with the patient. Acquiring data from the participant     will be conducted during several sessions, each lasting from 10 to 60 minutes, not exceeding     a total of 120 minutes. If the first recording is not of sufficient quality, the patient may     have it repeated once or twice.      Those participants who are found to have a clear seizure focus will proceed directly to     surgery that is part of their treatment. Those whose seizure focus is ambiguous will proceed     to invasive monitoring.      Participants will be followed in the outpatient clinic at intervals of 1, 3, 6, and 12     months. They may periodically undergo reimaging as considered appropriate.   "
171129|NCT00071331|"     The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults     with worsening congestive heart failure (CHF).   "
171150|NCT00077636|"     This study will evaluate the efficacy and safety of different durations of treatment with     PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never     previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12     months and the target sample size is 500+ individuals.   "
173752|NCT00108264|"     The purpose of this study is to use dendritic cells transfected with amplified RNA from     autologous tumor cells to develop a vaccine strategy for the treatment of prostate cancer in     patients with disseminated disease.   "
171130|NCT00071344|"     This study will examine patients with non-small cell lung cancer metastasis, that is, the     distant spreading of tumors to the brain, and compare them with patients without brain     metastasis. The molecular and genetic events that permit tumor metastasis are not well     understood. There is intense investigation going on into the process in which tumor cells     escape the primary local tumor, spread to distant places in the body, and find and create     conditions that promote growth in those tissues. Metastasis of tumors such as lung cancer to     the brain is a common problem. Tumor cells will be analyzed with the use of microarrays. A     microarray is a tool for analyzing gene expression, consisting of a small membrane or glass     slide containing samples of many genes arranged in a regular pattern. The goal is to identify     a potential molecular signature. It is hoped that there will be discovery of why some     patients are more likely than others to develop a brain metastasis, which can have a major     negative effect on the quality of life and survival.      Patients 18 years of age with known or evidence by radiology of a non-small cell lung cancer     metastatic to the brain, either squamous cells or adenocarcinoma tumors, or those who have     had a removal of a brain tumor for diagnosis or treatment may be eligible for this study.      Participants will undergo the following procedures and tests:        -  Craniotomy, that is, surgical opening of the skull, and removal of the brain tumor.        -  Blood specimens taken from a central vein or artery before the operation, throughout as          needed, and for several days afterward, to measure blood chemistries, blood count, and          so forth.        -  Physical examination and imaging of the central nervous system before and after surgery.        -  Urine or serum, or both, pregnancy test of women of childbearing potential.      Patients will also undergo blood tests at 3-month intervals after surgery for up to 5 years.     The purpose is to determine if there are tumor cells in the blood, which may explain how they     reached the brain.   "
182994|NCT00237913|"     Aripiprazole will show improved effectiveness over the standard of care treatment with one of     three atypical antipsychotics (olanzapine, quetiapine and risperidone).   "
171131|NCT00071357|"     This study will examine a non-invasive method to assess vasculature, that is, the development     of a blood supply necessary to the growth of tumors. The hope is to identify the way that     genes are expressed within the tumor itself, from areas shown as low flow versus those shown     as high flow on dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).      Most patients with solid epithelial cancers, those that develop on free surfaces or linings     inside the body, die because of the distant spread of tumors-metastasis. After that spread, a     cure is more difficult than if the tumors were detected early or locally. Tumors develop a     new supply of blood. Traditional anticancer therapies have had the goal of causing a decline     in the tumor. Yet by focusing on the tumor's blood supply, microscopic differences between     tumors and clonal differences within tumors may be avoided. Doing so may overcome tumor     resistance to treatment and may result in treatments that can be more universally applied     across tumor types.      Female patients 18 years of age enrolled in the protocol Analysis of Brain Metastasis in     Patients with Breast Cancer, with and without Over-Expression of HER-2, who will undergo an     MRI scan immediately before surgery will be invited to participate in this study. Patients     seen in the oncology outpatient clinic of the NIH Clinical Center or by referral from outside     physicians may be eligible for this study.      Participants will undergo DCE-MRI immediately before the craniotomy-the surgery scheduled-in     conjunction with other clinically indicated MRI. The preoperative MRI will take about 30     minutes, and the DCE-MRI will take no more than 15 minutes. During the MRI, patients will lie     still on a table that can slide in and out of a metal cylinder surrounded by a strong     magnetic field. They may be asked to lie still for up to 5 minutes at a time. As the scanner     takes pictures, there will be loud knocking noises, and the patients will wear earplugs to     muffle the sound. Patients will be able to communicate with the MRI staff at all times during     the scan and may ask to be moved out of the machine at any time. During part of the MRI,     patients will receive a contrast agent, one that is gadolinium-based, into a vein. This agent     changes the relative brightness or contrast on the MRI image under some conditions. Before     that agent is used, patients will be asked about any previous allergic reactions to     gadolinium-based contrast agents.   "
171132|NCT00071370|"     This study will evaluate how the state of being completely deprived of sleep has an effect on     recordings of magnetoencephalography (MEG) and electroencephalography (EEG), in relation to     how alert someone is and how sleepy someone perceives himself or herself to be. EEG measures     electronic potential differences on the scalp. On the other hand, MEG is a non-invasive     technique for recording the activity of neurons in the brain, through recording of magnetic     fields caused by synchronized neural currents. It has the ability to detect seizures. Because     magnetic signals of the brain vary, this technique must balance two key problems: weakness of     the signal and strength of the noise. The EEG is sensitive to extra-cellular volume currents,     whereas the MEG primarily registers intra-cellular currents. Because electrical fields are     quite dependent on the conductive properties of the tissues, and magnetic fields are     significantly less distorted by tissue, the MEG has better spatial resolution. There is a     great deal of evidence that EEG and MEG provide complementary data about underlying currents     of ions.      The complex relationship of sleep and epilepsy is well known. Sleep has been used for many     years as a powerful EEG activator. Many researchers have supported the hypothesis that there     is a specific activating effect of sleep deprivation on epileptic discharges. Sleep     deprivation is defined as a sleepless state of longer than 24 hours. The increased use of MEG     in diagnosis could improve the procedure for evaluating patients before surgery for epilepsy,     by making invasive studies less necessary.      Patients 18 years of age or older, with a diagnosis of epilepsy and with a documented last     routine EEG (at least 2 weeks earlier) and routine EEG on the day of a baseline MEG-EEG     without interictal epileptiform discharges (IEDs) may be eligible for this study.      Participants will be rated according to the Epworth, Stanford, and Karolinska Sleepiness     Scales, to determine their subjective sleepiness. They will be randomly assigned to stay     awake all night or sleep in the hospital overnight. That is, a sleep deprivation and     non-sleep deprivation synchronized MEG-EEG recording will be performed in random order. Then     the sequence of sleep deprivation and non-sleep deprivation will be reversed within 14 to 21     days. During the recordings, the patient will either sit or lie with his or her head in a     helmet covering the entire head, with openings for the eyes and ears. Brain magnetic fields     will be recorded with a 275-channel OMEGA system. Throughout the session, visual and two-way     audio communication will be maintained with the patient. Recording sessions will last 90 to     180 minutes, with the patient allowed to take breaks after at least 10 minutes in a scanner.     Attempts will be made to encourage patients to stay awake and sleep for about the same amount     of time during each recording, to acquire comparable amounts of sleep and awake recordings.   "
171133|NCT00071383|"     This study will examine two subsets of patients with breast cancer metastasis, that is,     spreading, to the brain. It will identify genes and proteins that promote metastasis,     particularly in women who are found to over-express (have more than other people do) the     human epidermal growth factor receptor, ErbB2, also known as HER-2. The molecular and genetic     events that permit tumor metastasis are not well understood. There is intense investigation     going on into the process in which tumor cells escape the primary local tumor, spread to     distant places in the body, and find and create conditions that promote growth in those     tissues. Metastasis of tumors such as breast cancer to the brain is a common problem. Tumor     cells will be analyzed with the use of microarrays. A microarray is a tool for analyzing gene     expression, consisting of a small membrane or glass slide containing samples of many genes     arranged in a regular pattern. The goal is to identify a potential molecular signature. It is     hoped that there will be discovery of why some patients are more likely than others to     develop a brain metastasis, which can have a major negative effect on the quality of life and     survival.      Female patients 18 years of age with known or evidence by radiology of a breast tumor     metastatic to the brain or those who have had a removal of a brain tumor for diagnosis or     treatment may be eligible for this study.      Participants will undergo the following procedures and tests:        -  Craniotomy, that is, surgical opening of the skull, and removal of the brain tumor.        -  Blood specimens taken from a central vein or artery before the operation, throughout as          needed, and for several days afterward, to measure blood chemistries, blood count, and          so forth.        -  Physical examination and imaging of the central nervous system before and after surgery.        -  Urine or serum, or both, pregnancy test of women of childbearing potential.      Patients will also undergo blood tests at 3-month intervals after surgery for up to 5 years.     The purpose is to determine if there are tumor cells in the blood, which may explain how they     reached the brain.   "
171134|NCT00071396|"     The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can     shrink or slow the growth of the disease in patients with chronic lymphoid disorders that     have either not responded or whose disease has returned after treatment with standard     therapies.   "
171135|NCT00071409|"     Insulin is a chemical that the body needs in order to use or store sugar. It is made by a     type of cell called a beta cell which resides in an organ known as the pancreas. Type 1     diabetes is a disease where the beta cells have been destroyed so that little or no insulin     is made. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt     to create new beta cells in the pancreas, and to restore the ability to produce insulin in     type 1 diabetic patients.   "
171136|NCT00071422|"     Insulin is a chemical that the body needs in order to use or store sugar. It is made by a     type of cell called a beta cell which resides in an organ known as the pancreas. Type 2     diabetes is a disease where the beta cells are unable to meet a person's insulin needs. Sugar     levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new     beta cells in the pancreas, and to improve the ability to produce insulin in type 2 diabetic     patients.   "
171151|NCT00077649|"     The effects of treatment with different doses of PEGASYS in combination with different doses     of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer,     body weight greater than 85kg (187lbs) and no prior treatment with interferon. The     anticipated time on study treatment is 3-12 months and the target sample size is 100-500     individuals.   "
171152|NCT00077662|"     Pompe disease (also known as glycogen storage disease type II, GSD-II) is caused by a     deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally,     GAA is used by the body's cells to break down glycogen (a stored form of sugar) within     specialized structures called lysosomes. In patients with Pompe disease, an excessive amount     of glycogen accumulates and is stored in various tissues, especially heart and skeletal     muscle, which prevents their normal function.      This study is being conducted to collect prospective, observational data on patients with     late-onset Pompe disease. Approximately 60 subjects with late-onset Pompe disease will be     enrolled.   "
171153|NCT00077675|"     Serious infections caused by resistant bacteria are becoming more of a medical problem     throughout the world. This study will measure how well TD-6424 (Telavancin) can control     infections and whether the drug is safe to give to patients.   "
171157|NCT00077753|"     Primary objective:        -  To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd          for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment          with enoxaparin 40mg sc qd      Secondary objectives:        -  To assess the reduction in mortality rate at the end of the double-blind treatment          period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to          the study, in patients on extended prophylaxis        -  To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization          to the study        -  To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical          patients with prolonged immobilization. Safety evaluation includes:             -  Major and minor hemorrhage             -  Heparin induced thrombocytopenia             -  Serious adverse events        -  To assess differences in levels of health-care utilization and cost between patients          receiving extended VTE prophylaxis versus those receiving placebo.   "
171799|NCT00087529|"     This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled,     multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The     study will enroll approximately 435 subjects at up to 60 sites in the United States and     Canada.   "
171137|NCT00071435|"     This study will examine whether the motor cortex (the part of the brain that controls     movement) works properly in patients with primary lateral sclerosis (PLS), a disorder in     which voluntary movements are very slow.      Healthy volunteers between 40 and 75 years of age and patients with ascending PLS (a subset     of PLS) may be eligible for this study. Patients with ascending PLS have a slowing of     finger-tapping movements that corresponds to a particular abnormality of certain neuronal     (nerve cell) activity.      Participants perform a finger-tapping reaction time exercise while brain wave activity     (electroencephalography, or EEG) and muscle activity (electroymogram, or EMG) are measured.     The subject is seated in front of a computer screen. A signal appears on the screen and the     subject taps a key as quickly as possible in response to the signal.      For the EEG, brain activity is recorded by placing electrodes (small metal discs) on the     scalp with an electrode cap or glue-like substance. A conductive gel is used to fill the     space between the electrodes and the scalp to make sure there is good contact between them.     The brain waves are recorded while the subject taps his or her fingers very slowly. For the     surface EMG, electrodes filled with a conductive gel are taped to the skin.      Participants also undergo magnetic resonance imaging (MRI). This test uses a strong magnetic     field and radio waves to obtain images of the brain. During the procedure, the subject lies     still on a table that can slide in and out of the scanner - a narrow metal cylinder. Scanning     time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes.     Subjects can communicate with the MRI staff at all times during the scan and can ask to be     moved out of the machine at any time.   "
171138|NCT00071448|"     This trial is conducted in the United States of America (USA). The aim of this trial is to to     determine whether insulin aspart can be used effectively and safely in paediatric patients.   "
171139|NCT00077454|"     This phase I trial is studying the side effects and best dose of erlotinib when given with     temozolomide in treating young patients with recurrent or refractory solid tumors. Erlotinib     may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs     used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from     dividing so they stop growing or die. Giving erlotinib with temozolomide may kill more tumor     cells.   "
171140|NCT00077467|"     This phase I trial is studying the side effects and best dose of bortezomib in treating young     patients with refractory or recurrent leukemia. Bortezomib may stop the growth of cancer     cells by blocking the enzymes necessary for their growth.   "
171141|NCT00077493|"     RATIONALE: BL22 immunotoxin can locate tumor cells and kill them without harming normal     cells. BL22 immunotoxin may be effective in treating relapsed or refractory acute     lymphoblastic leukemia and non-Hodgkin's lymphoma.      PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in     treating young patients with relapsed or refractory acute lymphoblastic leukemia or     non-Hodgkin's lymphoma.   "
171142|NCT00077519|"     RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary     for their growth and may make them more sensitive to radiation therapy. Radiation therapy     uses high-energy x-rays to damage tumor cells. Giving tipifarnib together with radiation     therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when     given together with radiation therapy in treating patients with unresectable locally advanced     pancreatic cancer.   "
171143|NCT00077532|"     RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the     immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make     the body build an immune response to kill tumor cells. Combining the vaccines with Montanide     ISA-51 may cause a stronger immune response and kill more tumor cells. It is not yet known     whether monoclonal antibody therapy is more effective with or without vaccine therapy in     treating advanced melanoma.      PURPOSE: This randomized phase II trial is studying monoclonal antibody therapy alone to see     how well it works compared to monoclonal antibody therapy, gp100 peptides, and Montanide     ISA-51 in treating patients with stage IV melanoma.   "
171144|NCT00077545|"     Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor     cells from dividing so they stop growing or die. 3-AP may help cisplatin kill more cancer     cells by making them more sensitive to the drug. This phase II trial is studying how well     giving 3-AP together with cisplatin works in treating patients with recurrent or metastatic     adenocarcinoma of the esophagus or gastroesophageal junction.   "
171145|NCT00077558|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop     cancer cells from dividing so they stop growing or die. 3-AP may help fludarabine kill more     cancer cells by making them more sensitive to the drug.      PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when     given together with 3-AP in treating patients with relapsed or refractory acute leukemia,     chronic leukemia, or high-risk myelodysplastic syndrome.   "
171146|NCT00077584|"     In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without     digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers     versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and     healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.   "
171147|NCT00077597|"     This study will assess the efficacy and safety of Mircera given intravenously in the     treatment of renal anemia in chronic kidney disease patients on dialysis who are not     currently receiving epoetin or any other erythropoietic substance. The anticipated time on     study treatment is 1-2 years and the target sample size is 100-500 individuals.   "
171148|NCT00077610|"     This study will assess the efficacy and safety of intravenous Mircera, given as maintenance     treatment for renal anemia in chronic kidney disease patients on dialysis who were previously     receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target     sample size is 100-500 individuals.   "
171149|NCT00077623|"     This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as     maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who     were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years     and the target sample size is 100-500 individuals.   "
171154|NCT00077688|"     Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel     in taxane-naive patients receiving second line chemotherapy for metastatic or locally     advanced, unresectable transitional cell carcinoma of the urothelium   "
171158|NCT00077766|"     This study will assess the efficacy and safety of intravenous (iv) Mircera given as     maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who     were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2     years and the target sample size is 100-500 individuals.   "
171159|NCT00077779|"     The purpose of this study is to test whether Adalimumab (at two different doses) can induce     and maintain clinical remission in subjects with active Crohn's disease when compared to     placebo (a substance containing no medication)   "
171160|NCT00077792|"     The primary objective of the study is to determine whether enoxaparin compared to     unfractionated heparin will reduce the composite endpoint of all-cause mortality and     non-fatal myocardial re-infarction within 30 days after randomization in patients with acute     ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy   "
171161|NCT00077805|"     Primary objective:        -  To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared          to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 days following          acute ischemic stroke.      Secondary objectives:        -  To compare the incidence of VTE between the 2 treatment groups at 30, 60, and 90 days          from the time of randomization        -  To compare neurologic outcomes between the 2 treatment groups, including incidence of          stroke recurrence, rate of stroke progression, and patient functional status, during the          10 ± 4 days of treatment, and after 30, 60, and 90 days from the time of randomization        -  To evaluate the safety of using enoxaparin compared to UFH for VTE prevention in          patients following acute ischemic stroke   "
171162|NCT00077818|"     The purpose of this study is to determine the efficacy and safety of enoxaparin compared to     unfractionated heparin (UFH) for patients diagnosed with Acute Coronary Syndrome (ACS) in the     emergency department (ED). Efficacy is assessed by using a composite score consisting of     30-day all-cause mortality, non-fatal myocardial infarction (MI) and recurrent angina     requiring revascularization.   "
171163|NCT00077831|"     To learn more about the cognitive and motor development of infants and young children born     with a craniofacial defect called craniosynostosis.   "
171164|NCT00077844|"     The purpose of this study is to evaluate the efficacy and safety of intravenous enoxaparin     versus intravenous unfractionated heparin (UFH) in patients undergoing non-emergent PCI, as     assessed by measuring the incidence of non-coronary artery bypass graft (CABG) major and     minor bleeding.   "
171165|NCT00078182|"     Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other     anti-HIV drugs to treat HIV infection. Taking tenofovir DF every day may also prevent HIV     infection. This study will determine if taking a tenofovir DF tablet every day is safe and     effective in preventing HIV infection. Participants in the study will be sex workers in Phnom     Penh, Cambodia.   "
171166|NCT00078195|"     A series of allergy shots may reduce symptoms of seasonal ragweed allergies. This study will     determine whether taking a drug called omalizumab (also known as Xolair) before getting the     allergy shots is more effective than allergy shots alone or other treatments, such as     prescription antihistamines.   "
171167|NCT00078208|"     This study will evaluate the usefulness of a new procedure for evaluating asthma in children.     The method measures the pH (a measure of acidity and alkalinity) of exhaled breath condensate     (water vapor created by the lungs). The condensate contains products of the lungs that may be     associated with lung inflammation. Investigators will determine if the pH of the exhaled     breath condensate correlates well with known asthma indicators, such as number of     hospitalizations, school absenteeism, use of rescue medication, and others. Test results will     be compared with findings from healthy normal volunteers. No experimental treatments or     medicines are used in this study. Patients who require treatment for their asthma will     receive standard care with medicines approved by the Food and Drug Administration and used     widely in the United States.      Children with asthma and healthy normal volunteers between 6 and 17 years of age may be     eligible for this study. You must complete the study before your 18th birthday. Candidates     are screened with a medical history and physical examination.      Children with asthma undergo the following tests and procedures over six clinic visits,     including an initial visit and follow-up visits at 4-8 weeks, 3, 6, 9, and 12 months:        -  Blood draw in children over 6 years of age. Medications are available to decrease the          pain associated with blood drawing.(initial visit)        -  Allergen skin testing: Drops of up to 16 allergens are placed on the arm. The skin under          each drop is scratched and the area is observed for an allergic reaction. (4- 8-week          follow-up visit)        -  Expired nitric oxide testing: The child breathes into a balloon to collect a portion of          the gases exhaled form the lungs. This test measures the amount of nitric oxide, which          correlates with bronchial inflammation. (all visits)        -  Exhaled breath condensate: The child breathes into a plastic tube surrounded by a cold          metal sleeve for 10 to 15 minutes. The water vapor created by the lungs (the same vapor          that forms when breathing outside on a cold day) is collected and the pH measured. (all          visits)        -  Pulmonary (lung) function test: The child blows very hard into a tube attached to a          machine to measure the airflow from the child's lungs. This test measures airflow from          the lungs. (all visits) The children are given small plastic device called a peak flow          meter - a device used to measure lung function - to use at home. Children whose lung          function is less than 80% of the predicted value for their age may be given medicine to          see if their lung function improves.        -  Review of the patient's symptoms, sick days, medicines or actions taken to get over the          illness; review of peak flow reports; and review of action plan. (3-, 6-, 9-, and          12-month visits)      Healthy controls will have the expired nitric oxide test, exhaled breath condensate test, and     pulmonary function test at each visit at the initial and over two additional visits scheduled     6 months apart.   "
171168|NCT00078221|"     AMD is a progressive disease of the retina which is nourished by a network of tiny blood     vessels. There is evidence to suggest that the flow of nutrients to the retina is impaired in     patients with AMD. Rheopheresis blood filtration uses blood filters that deplete excesses of     large proteins, fats and other substances from the blood, improving blood flow to the macula,     potentially improving vision.   "
171169|NCT00078234|"     The treatment combination of Rituxan® (rituximab) and fludarabine has previously been     reported to produce a high percentage of responses with less toxicity than other combination     treatments. However, some leukemia subjects continue to have leukemia despite treatment with     these standard anticancer drug therapies, or they may work for only a short period of time.     In some subjects, when the leukemia does not respond well to therapy the leukemia cells may     be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a     protein that appears to protect cancer cells from being killed and thus lengthens the life of     the cancer cells. Genasense® (oblimersen sodium) is a compound that blocks production of the     Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may     work more effectively as a cancer treatment. Genasense® may also directly kill CLL cells.     This study will test whether treating subjects with Genasense®, fludarabine and rituximab is     safe and effective.   "
171170|NCT00078247|"     This study is designed to determine whether 6 months of anti-HIV drugs given along with     tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.   "
171849|NCT00081627|"     The objectives of this trial are to determine if CoFactor in combination with 5-FU are     effective in the treatment of metastatic colorectal cancer and to determine the side effects     observed with the administration of CoFactor and 5-FU.   "
171171|NCT00078260|"     The purposes of this study are to determine:        -  the safety of pemetrexed and any side effects that might be associated with it        -  how much pemetrexed should be given to patients.      It is possible that information collected during this study will be analyzed by the Sponsor     in the future to evaluate pemetrexed for other possible uses or for other medical or     scientific purposes other than those currently proposed.      Although pemetrexed has been shown to be effective in some patients with non-small-cell lung     cancer, pemetrexed might not have beneficial effects for all patients.   "
171172|NCT00078273|"     The overall purpose of this study is to reduce the prevalence of gambling risk in college     students by evaluating the effectiveness of different treatments in reducing gambling     behavior and related negative consequences.   "
171173|NCT00078286|"     This study will examine the effect of antidepressant medication on rates of death and disease     in depressed people with chronic heart failure.   "
171174|NCT00078299|"     This study will evaluate a system developed to grade the severity of age-related cataract, a     common cause of vision loss in older adults. Cataract research requires methods to simply and     accurately determine the type and severity of cataracts in order to develop new, possibly     non-surgical, treatments.      Patients 50 years of age and older with one of the three major age-related cataract types     (nuclear, cortical, and posterior subcapsular) may be eligible for this study. Participants     will be recruited from among patients enrolled in other National Eye Institute protocols.      Participants will have their eyes examined independently by two ophthalmologists with a     biomicroscope, a magnifying device routinely used during eye examinations. The doctors will     use the new grading system to record if a cataract is present, and if so, how severe it is.     The examination includes measurement of visual acuity (vision chart test) and examination of     the lens, retina, pupils and eye movements. Photographs of the eye will be taken using a     special camera that flashes a bright light in the eye.   "
171175|NCT00078312|"     The primary objective of this study is to evaluate the safety and tolerability of Armodafinil     (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12     months to patients with excessive sleepiness associated with a current diagnosis of     narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal     continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder     (SWSD).   "
171176|NCT00078325|"     The primary objective of this study is to determine whether treatment with Armodafinil     (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness     associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep     latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps     at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings     (as related to general condition) at week 12, or last post-baseline visit.   "
171177|NCT00078338|"     The primary objective of the study is to assess the clinical efficacy of Rebif® 44 mcg three     times per week compared with Copaxone® 20 mg daily in patients with relapsing Multiple     Sclerosis.   "
171178|NCT00078351|"     This study will examine the effectiveness of injected hylan (Synvisc) for treating pain     associated with osteoarthritis of the temporomandibular joint (jaw joint) and improving     function of the joint. Hylan is a synthetic product very similar to a component of normal     healthy joint fluid (synovial fluid), which is present in much lower quantities and is     abnormal in osteoarthritis. Hylan injections have been beneficial in treating osteoarthritis     of the knee.      Patients with temporomandibular (TMJ) joint pain of at least 3 months duration who have mouth     opening limitation and moderate to severe joint pain made worse by joint movement may be     eligible for this study. Patients must not have any TMJ growth disturbances and must not have     had any TMJ surgery for 6 months before entering the study. Candidates are screened with     questionnaires, a medical history, and a physical examination of the TMJs, including x-rays     and magnetic resonance imaging.      Participants are randomly assigned to receive three injections, each a week apart, of either     Synvisc or placebo (a salt-water solution) into the affected joint. Before the first     injection, a sample of synovial fluid is collected from the joint by needle aspiration for     laboratory analysis. Patients return for follow-up visits 3, 6, and 12 months after the last     treatment for a clinical examination of the jaw joint and review of jaw joint symptoms. A     second aspiration is requested at the 3-month visit, but is not mandatory. All injections and     aspirations are done after anesthetizing the overlying skin and joint capsule to minimize     pain or discomfort. Participants record their daily use of pain relief medication throughout     the study.   "
171199|NCT00078637|"     This is a first-in-man, open-label, non-randomized, multiple dose, multiple cycle, dose     escalation study to determine the MTD, safety, PK, and pharmacodynamics of E7820 in patients     with a malignant solid tumor or lymphoma.   "
171214|NCT00078910|"     RATIONALE: Drugs used in chemotherapy, such as exisulind, work in different ways to stop     tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before     surgery may shrink the tumor so that it can be removed.      PURPOSE: This phase II trial is studying how well neoadjuvant exisulind works in treating     patients who are undergoing radical prostatectomy for stage II or stage III prostate cancer.   "
173753|NCT00108277|"     This study will explore respiratory dysregulation in anxious outpatients and examine the     effect of breathing training with biofeedback for those anxious patients.   "
171200|NCT00078663|"     This study will evaluate whether a program of systematic oral care can help prevent     hospital-acquired respiratory infections in patients in intensive care units. Such infections     occur five times more often in critically ill patients compared with patients in general     hospital wards and result in longer hospital stays and an increased risk of death. The rate     of respiratory infection among critically ill patients correlates strongly with the presence     of disease-causing bacteria in the mucosal areas of the mouth, gums, and teeth, indicating     that assiduous oral care is especially important in this patient population. This study will     compare a program of meticulous oral care using oral assessments taught by a dentist and     dental hygienist with the standard care typically given in intensive care units.      Critically ill patients 18 years of age and older who are hospitalized in an intensive care     unit for 3 or more days and whose oral hygiene is dependent on hospital care providers may be     eligible for this study. Patients will be recruited from intensive care units at four     Washington, D.C., area hospitals - Suburban Hospital, Washington Hospital Center, Inova     Fairfax Hospital, and Winchester Medical Center.      Participants will have their lips, mouth, gums, teeth, and saliva examined several times a     day to determine their optimum oral care. They will receive standard care, such as flossing,     brushing, rinsing with a mouthwash, and possibly use of an antiseptic spray that prevents     bacteria from clinging to the teeth. Small samples of saliva (less than one-fourth of a     teaspoon) and dental plaque will be collected the day the patient is admitted to the     intensive care unit and again on days 3 and 5 of their stay in the unit. The saliva sample is     collected with a small suction tube placed in the corner of the mouth; the plaque specimen is     collected by gliding a tiny piece of paper over the surface of a front tooth. The samples     will be examined for any bacteria not normally found in saliva.   "
171179|NCT00078364|"     This study will evaluate brain pathways involved in feeling pain and pain relief following     administration of pain medication. Magnetic resonance imaging (MRI) will be used to measure     brain activity at sites that become more active following oral surgery and then to see if the     activity changes after pain medication is administered. MRI combines a powerful magnet with     an advanced computer system and radio waves to produce detailed pictures of organs and     tissues. During the scan, the subject lies on a table in a narrow cylinder containing a     magnetic field. He or she can speak with a staff member via an intercom system at all times     during the procedure.      Healthy dental patients recruited through the NIH Clinical Research Volunteer Program may     enroll in this study. Participants will undergo the following tests and procedures in two     clinic visits:      Visit 1 - Sensitivity Testing      Participants are tested for sensitivity to warm and hot temperatures. A probe is applied to     the skin (usually the forearm) and heated to temperatures ranging from room temperature to     that of a hot cup of coffee. Participants rate the temperature using a scale ranging from no     pain to the worst pain imaginable and rate the unpleasantness of the heat using a similar     scale. The probe is applied up to 30 times, using random heat intensities. Participants are     also asked compare the heat intensity to varying levels of sounds and to rate the magnitude     of different sensations they have experienced in the past, such as the brightness of the sun     and the loudness of a jet plane. A blood sample of about 2 ounces is also collected at this     visit for DNA analysis to look for genes related to pain.      Visit 2 - Oral Surgery      Under local anesthetic, participants undergo extraction of their lower right wisdom tooth.     After surgery, the patient is moved to the MRI scanner for brain imaging over 1-2 hours while     the local anesthetic wears off. Patients may request a postoperative pain drug (Toradol)     during the procedure, if needed. When the scan is complete, patients are dismissed from the     clinic with additional pain medication (flurbiprofen) to use at home as directed.   "
171180|NCT00078377|"     The primary objective of this study is to determine whether treatment with Armodafinil     (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness     associated with narcolepsy by measuring mean sleep latency from the Maintenance of     Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500)     and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general     condition) at week 12 (or last postbaseline observation)   "
171181|NCT00078390|"     A study to measure the safety and effectiveness of S-3304 when given in combination with     conventional chemo-radiation therapy in patients with locally advanced non-small cell lung     cancer.   "
171182|NCT00078403|"     Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal     liver disease. The purpose of this study was to test the effectiveness of long-term pegylated     interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in     people infected with both HIV and HCV.   "
171183|NCT00078429|"     To investigation the association of thrombosis and inflammation genes with sub-clinical     cardiovascular disease and with incident myocardial infarction and stroke in older adults.   "
171184|NCT00078442|"     Recombinant interferon (IFN) may be useful in the treatment of HIV. However, the high doses     of IFN necessary to keep HIV under control limit its use due to toxic side effects. The     purpose of this study is to test the safety and tolerability of weekly recombinant pegylated     interferon (PEG-IFN) alfa-2a in HIV infected people who are currently on antiretroviral     therapy (ART) interruption or who have not started taking anti-HIV drugs.   "
171185|NCT00078455|"     This is a Phase II, non-randomized, open label study of ILX651 in patients with locally     advanced or metastatic non-small cell lung carcinoma (NSCLC). Approximately 60 patients will     be enrolled in this study that is expected to last 18 months. All patients will be treated     with ILX651 administered intravenously (IV) daily for 5 consecutive days once every 21 days.     The primary objective of this study is to determine the overall response rate. The secondary     objectives are to determine the progression free survival, duration of response, time to     tumor progression, survival, safety/tolerability of ILX651, and to evaluate pharmacokinetic     profile.   "
171186|NCT00078468|"     To determine the response rate in patients with metastatic colorectal cancer who failed     treatment with a 5-Fluorouracil/Leucovorin regimen and up to one other chemotherapeutic     regimen (not including adjuvant chemotherapy).   "
171187|NCT00078481|"     This study will determine the highest amount of idebenone that can be taken without harmful     side effects in children, teenagers, and adults with Friedreich's ataxia, a progressive     degenerative disease that affects several body systems. Studies in France and Canada showed     that patients with Friedreich's ataxia who took idebenone had a decrease in the size of their     left ventricle (main pumping chamber of the heart), which is often enlarged in this disease.     It is possible that idebenone may also prevent the progression of nervous system degeneration     in Friedreich's ataxia.      Patients 5 years of age and older with Friedreich's ataxia may be eligible for this study.     Candidates are screened with a blood test and review of their medical records, including     genetic studies.      Participants undergo the following procedures during a 6-day hospital admission to the NIH     Clinical Center:        -  Placement of an intravenous catheter (plastic tube inserted into a vein) for collecting          blood samples after drug administration        -  Blood and urine tests        -  Heart examination, including electrocardiogram (EKG), to assess heart function and size.        -  Idebenone therapy: Patients take three tablets a day (at 7 AM, 1 PM and 7 PM) on days 2,          3 and 4 of hospitalization. Blood samples are collected through the IV tube at 0.5, 1,          2, 4, and 6 hours after the first dose on day 2, then at 1 hour after the first and          third doses every day, and then at 1, 2, 4, 8, 12, 24, 36, and 48 hours after the last          dose on day 4 to determine how the body uses and eliminates the drug.        -  Monitoring for drug side effects: Patients have frequent checks of vital signs (blood          pressure, pulse, temperature, breathing rate) and a brief physical examination to check          for drug side effects from the start of drug therapy on day 2 until at least 43 hours          after the last dose on day 4.      Patients who experience no difficulties are discharged from the hospital after the sixth day     with a 1-month supply of medication to take 3 times a day at home. They are contacted by     phone every 2 weeks while taking the medication to check side effects. Blood tests are also     done every 2 weeks to check for any abnormalities.   "
171188|NCT00078494|"     This study will examine the effectiveness and side effects of an experimental vaccine to     prevent recurrence of nasopharyngeal cancer. The likelihood of this cancer returning is     higher in patients whose original lesion was large, whose cancer had spread to the adjacent     lymph nodes, or who had surgery for metastatic disease (cancer that spread beyond the primary     site). Nasopharyngeal tumors are caused by a common virus called Epstein-Barr virus, which     produces a protein called LMP-2. Vaccination with specific pieces, or peptides, of the LMP-2     protein may boost the immune system's fight against the cancer. The vaccine injections are     mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the     immune response to the peptide.      Patients 18 years of age and older whose nasopharyngeal cancer has been controlled by     standard treatment with surgery, chemotherapy, or radiation therapy and who are currently     free of disease may be eligible for this study. Candidates are screened with a physical     examination and blood and urine tests. x-rays and other imaging studies are also done in     patients who have not had these tests recently. All candidates are tested for HLA tissue     type. Only patients with type HLA-A*1101 or HLA-A*2402 - the types on which the two vaccines     in this study are based - receive vaccine therapy; others are offered standard medical     treatment and observation.      Participants are randomly assigned to receive injections of one of two different vaccines     (LMP-2:340-349 or LMP-2:419-427) to determine which peptide may offer the best immunity. Each     treatment course consists of weekly immunizations for 8 consecutive weeks. The injections are     given under the skin of the thigh. After every other treatment course (about every 3 months),     patients undergo a series of x-rays and scans to look for tumor. The immunizations are given     at the NIH Clinical Center. Patients are monitored for 1 hour after each injection and have     blood tests and a physical examination to look for treatment side effects. Immunizations may     continue for up to 12 months as long as the cancer does not return.      Patients are followed with blood tests every 12 weeks to monitor body functions. They also     undergo leukapheresis-a procedure to collect white blood cells-before starting treatment and     about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect the action of     the immune system cells. For this procedure, blood is drawn through a needle in the arm,     similar to donating blood. The blood is processed by a machine that separates and removes the     lymphocytes (white blood cells), and the rest of the blood is returned through a needle in     the other arm. Patients not receiving the vaccine also undergo leukapheresis to assess their     natural response to LMP-2. Some patients may have a biopsy-surgical removal of a small piece     of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the     vaccine's effects on the tumor immune cells.      Patients who show no evidence of immunization against the LMP-2 protein after two courses of     vaccine treatment are subsequently be followed with observation alone. Those who do respond     to the vaccine are offered two additional courses of treatment to strengthen the response or     to be followed by observation alone. Patients whose disease recurs after completing the first     two treatment courses are taken off the study and referred back to their local physician or     to another study, if an appropriate one is available.   "
171189|NCT00078507|"     The purpose of this study is to determine whether facial exercises in conjunction with     opening exercises routinely provided after facial surgery to correct a facial skeletal     disharmony will shorten the time until a patient receives no unpleasant or negative facial     sensation.   "
171190|NCT00078520|"     This study is for patients that have chronic lymphocytic leukemia (CLL). This research study     aims to determine the safety and dosage of special cells that may make the patients own     immune system fight the cancer.      To do this, we will put a special gene into cancer cells that have been taken from the     patients body. This will be done in the laboratory. This gene will make the cells produce     interleukin 2 (IL-2), which is a natural substance that may help the immune system kill     cancer cells. Additionally, we will stimulate the cancer cells with another natural protein     called CD40 ligand (CD40L), which experiments in animal and human cells in vitro demonstrated     can help IL-2 perform better.      Some of these cells will then be put back into the patient's body. Studies of cancers in     animals and in cancer cells that are grown in laboratories suggest that combining substances     like IL-2 and CD40L helps the body kill cancer cells. An experimental treatment similar to     this has already been used in children and similar experimental treatments are being used in     adults with other cancers.   "
171201|NCT00078689|"     This study will examine whether the combination of the drugs daclizumab and sirolimus can     effectively treat adults with uveitis, an eye inflammation. Daclizumab is a monoclonal     antibody that is designed to prevent a specific chemical interaction needed for immune cells     called lymphocytes to produce inflammation. Sirolimus is an immune-suppressing drug that also     controls lymphocyte activity and is marketed to prevent organ rejection in kidney     transplants.      Patients 18 years of age and older with non-infectious uveitis in one or both eyes who are     being treated with daclizumab and have not had a relapse or disease flare for 6 months before     entering this trial may be eligible for this study. Candidates are screened with a medical     history and physical examination, blood tests, complete eye examination, and pregnancy test     for women who can have children. Women of child-bearing potential who enroll in this study     will have a pregnancy test every 12 weeks.      After enrollment, participants have the following additional exams:        -  Fluorescein angiography: This test is done to check for abnormalities of eye blood          vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in          the eyes. Pictures of the retina are taken with a special camera that flashes a blue          light into the eye. The pictures show if any dye has leaked from the vessels into the          retina, indicating possible abnormalities. This test is done at enrollment and after 1          year, unless additional tests are needed for medical management.        -  Pelvic ultrasound and urine test: These tests are done at enrollment and after 1 year to          check the kidneys, lymph nodes, and pelvic area.        -  Blood tests: Blood tests are done at enrollment and every 3 to 6 months for laboratory          and immunology study      Patients receive daclizumab subcutaneously (under the skin) or in infusions at regularly     scheduled visits for 52 weeks. At each treatment, blood pressure, pulse, breathing rate, and     temperature are monitored. After the first 52 weeks, patients whose disease remains quiet     increase the time between injections to 6 weeks and then to 8 weeks. Patients who are doing     well at this time may stop daclizumab.      One or 2 days after the first daclizumab treatment, patients receive 6 mg of sirolimus by     mouth. Their blood pressure, pulse, breathing rate, and temperature are monitored for at     least 60 minutes. Two days after the first dose, patients begin 2-mg maintenance doses every     other day for 2 weeks. If there are no intolerable side effects, the dose is increased to 2     mg daily for the next 2 weeks. Patients who have no intolerable side effects at that dose     continue the medication for another 4 weeks. Patients who experience intolerable side effects     may decrease the medication to every other day or withdraw from the study. After week 78 of     the study, if the daclizumab treatments are stopped, the sirolimus dose is reduced within 8     weeks and may eventually be discontinued if the patient continues to do well.      Patients who experience any of the following will leave the study:        -  Inflammation flare that requires concomitant treatment with additional systemic          immunosuppressive medications, such as prednisone or cyclosporine        -  Disease flares more than twice in the first year        -  Any disease flares in the second year   "
171191|NCT00078533|"     Patients have a type of blood cell cancer, other blood disease or a genetic disease for which     they will receive a stem cell transplant. The donor of the stem cells will be either a     brother or sister or another relative or a closely matched unrelated donor. We are asking     patients to participate in this study which tests if blood cells from the donor that have     been grown in a special way, can prevent the patients from getting an infection with a virus     called Cytomegalovirus or CMV.      CMV is a virus that can cause serious infections in patients with suppressed immune systems.     It usually affects the lungs and can cause a very serious pneumonia, but it can also affect     the intestinal tract, the liver and the eyes. Approximately 2/3 of normal people harbor this     virus in their body. In healthy people CMV rarely causes any problems because the immune     system can keep it under control. If the patient and/or their donor is positive for CMV, they     are at risk of developing CMV disease while the patients immune system is weak post     transplant. Usually, this risk is highest during the first 3-4 months after the transplant.      CMV disease can be prevented during this time in most people by using drugs that can kill the     virus such as Ganciclovir, Foscarnet, or Cidofovir . However, these medications have many     side effects and have to be given daily by vein for approximately 4-5 months after     transplant. One of the side effects is that it takes the new immune system much longer to     develop an effective defense against the virus. Therefore, once the medicines are stopped,     the patients still have a chance to develop CMV disease.      We want to see if we can use a kind of white blood cell called T cells that we have grown     from the stem cell donor instead of the regular treatment with Ganciclovir or Foscarnet to     prevent CMV from flaring up. These cells have been trained to attack CMV virus infected     cells. We will grow these T cells from blood taken from the donor before the patients     transplant. These cells are called CMV-specific cytotoxic T-lymphocytes or CMV CTL, and they     will be given to the patient around 30 days after their transplant.      We have used this sort of therapy to treat a different virus which can cause problems after     transplant called Epstein Barr Virus (EBV). Doctors at other places have used similar T cells     to treat or prevent CMV infections after transplant and have not seen any significant     problems. These CMV specific cytotoxic T cells are an investigational product not approved by     the Food and Drug Administration.   "
171192|NCT00078546|"     To determine the safety of the combination of CD45 monoclonal antibody (Mab) followed by     intravenous injection of EBV specific CTL in patients with nasopharyngeal cancer.      To compare the expansion, persistence and anti-tumor effects of the EBV specific CTL given     after CD45 Mab administration with that observed in our first study.      To obtain preliminary information on the safety and response to an extended dosage regimen of     EBV-specific CTL in patients, who have stable disease or a partial response after the initial     dose of EBV-specific CTL.   "
171193|NCT00078559|"     Transplant rejection occurs when a patient's body does not recognize the new organ and     attacks it. Patients who have kidney transplants must take drugs to prevent transplant     rejection. Alemtuzumab is a man-made antibody used to treat certain blood disorders. The     purpose of this study is to test the safety and effectiveness of using alemtuzumab in     combination with two other drugs, sirolimus and tacrolimus, to prevent organ rejection after     kidney transplantation. This study will also test whether this combination of medications     will allow patients to eventually stop taking antirejection medications entirely.      Study hypothesis: A new strategy of immunosuppression using alemtuzumab, tacrolimus, and     sirolimus for human renal transplantation will permit a step-wise withdrawal from     immunosuppressive drugs.   "
171194|NCT00078572|"     This study was designed to compare the efficacy and safety of an oral dual tyrosine kinase     inhibitor in combination with capecitabine versus capecitabine alone in women with locally     advanced or metastatic breast cancer that has not responded to previous therapy.   "
171195|NCT00078585|"     PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the     immune system can be taught to fight cancer by directing the immune system to attack specific     targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's.     This trial will help determine if this vaccine can help fight cancer.      This multi-center, double-blind, randomized, empty vector-controlled trial is designed to     evaluate the safety and efficacy of PROSTVAC-VF/TRICOM co-administered with GM-CSF versus the     empty viral vector co-administered with placebo in the treatment of patients with     androgen-independent prostate cancer (AIPC).      All patients will be required to sign an informed consent prior to the performance of any     on-study procedures. Patients will be screened for eligibility within 14 days prior to     vaccine administration. Patients who meet all inclusion and exclusion criteria will be     centrally randomized into the study and will receive a unique patient identification number     and a blinded treatment assignment. The ratio of active treatment to empty vector control     (placebo) is 2:1.   "
171196|NCT00078598|"     A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States     and Europe.      Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will     receive 375 mg/m2 of rituximab (US, Canada – Rituxan®; EU - Mabthera®), given as an IV     infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab     therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the     “dosimetric dose,” patients will receive an infusion of unlabeled Tositumomab (450 mg)     immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi     (0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0,     Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data from     these three imaging timepoints, the patient’s weight, and platelet count, a patient-specific     administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq) will be     calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In the second     phase, termed the “therapeutic dose,” patients in Arm B will receive an infusion of unlabeled     Tositumomab (450 mg) immediately followed by an infusion of the patient-specific administered     activity of Iodine 131–conjugated Tositumomab (35 mg).      Patients on study will be followed for response and safety at Week 7, Week 13, and every 3     months for the first and second years, every 6 months for the third year, and then annually     for the fourth and fifth years. Patients will be followed for safety only annually for years     6-10.   "
171197|NCT00078611|"     The purpose of this trial is to evaluate natalizumab in individuals with moderately to     severely active Crohn's Disease.   "
171198|NCT00078624|"     People with knee osteoarthritis (OA) frequently complain of knee instability. This study will     test whether certain exercises can improve knee stability, reduce pain, and improve physical     function in people with knee OA.      Study hypotheses: 1) Participants in the stability training group will demonstrate less pain     and higher levels of physical function, based on self-report measures of pain and function     (WOMAC, Lower Extremity Function Scale), and less time to complete the Get Up and Go test, a     physical performance measure of function. 2) During walking and the step down task,     participants in the stability training group will demonstrate greater knee motion during     weight bearing, greater vertical ground reaction forces and loading rates, and reduced ratios     of co-contraction between quadriceps/hamsting and tibialis anterior/gastrocnemius muscle     pairs compared to the standard group. Participants in the stability group will also     demonstrate greater step lengths, single limb support times, and average walking velocity     compared to the standard group.   "
171202|NCT00078715|"     This study examines if Yohimbine, when given during the sleep cycle, will improve symptoms of     depression within a matter of hours.      Purpose: This study will examine whether the drug yohimbine, given at a specific time during     the sleep cycle, produces chemical changes in the brain similar to those that occur with     sleep deprivation. It will also see if yohimbine can induce rapid (next day) antidepressant     effects in patients with major depression. Total sleep deprivation for 36 hours improves mood     in most patients with major depression in a matter of hours, but the response is usually     short-lived. Understanding the chemical changes that occur in the body during sleep     deprivation may help in the development of a rapidly acting antidepressant.Patients with     major depressive disorder between 18 and 65 years of age may be eligible for this study.     Candidates are screened with a medical and psychiatric history, physical examination,     electrocardiogram, and blood and urine tests. Participants are hospitalized at the NIH     Clinical Center for the study, as follows: Drug-free period: Patients are tapered off their     anti-depression medications and remain drug-free for 1 week before beginning study phase 1.     Study phase 1: Patients undergo sleep deprivation for 36 hours. Those whose depression     improves with sleep deprivation initially and then worsens continue to phase 2. The day after     sleep deprivation, patients undergo a lumbar puncture (spinal tap). For this test, a local     anesthetic is given and a needle is inserted in the space between the bones in the lower back     where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is     collected through the needle. Study phase 2: Patients spend 1 night in the sleep lab. A     catheter (plastic tube) is placed in a vein in each arm-one to give yohimbine and the other     to draw blood samples. A small monitor cuff is placed on a finger to measure the patient's     blood pressure and blood oxygen levels during the night. While asleep, the patient receives a     dose of yohimbine or placebo, given over 3 minutes. A lumbar puncture is done the following     morning. Patients receive no medications for 6 days, and then the sleep lab procedure is     repeated. Patients who received yohimbine in the previous experiment are switched to placebo,     and those who were given placebo are switched to yohimbine.   "
171203|NCT00078728|"     This study will evaluate the effectiveness of a short-term family-based program for     preventing anxiety disorders in at-risk children.   "
171204|NCT00078741|"     This study will develop a cognitive behavioral therapy (CBT) program to treat symptoms of     post-traumatic stress disorder (PTSD) in people with severe mental illnesses who are treated     within community mental health systems.   "
171205|NCT00078754|"     This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for     the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder     (IED).   "
171206|NCT00078767|"     This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused     Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic     Stress Disorder (PTSD).   "
171207|NCT00078793|"     This study will evaluate long-term safety of etanercept with or without other DMARDs in     children with polyarticular course or systemic juvenile rheumatoid arthritis (JRA) compared     to a cohort of subjects with polyarticular or systemic JRA receiving methotrexate with or     without other DMARDs.   "
171208|NCT00078806|"     Rationale: etanercept inhibits the effects of tumor necrosis factor, which plays an important     role in the progression of rheumatoid arthritis. A study of children with polyarticular     course juvenile rheumatoid arthritis showed that Enbrel had efficacy and was generally well     tolerated in children ages 4-17 who had moderately to severely active disease and who failed     treatment with one or more disease modifying antiarthritic drugs. The children in the study     may have had arthritis onset of pauciarticular, polyarticular, or systemic nature. Systemic     onset juvenile rheumatoid arthritis (SOJRA) may result in approximately one-third of patients     having significant long-term disability. Purpose: the Phase 4 study is designed to further     define the safety and efficacy of etanercept in those children with SOJRA.   "
171209|NCT00078819|"     This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with     Psoriasis.      This is a Phase 3 blinded, placebo-controlled study.   "
171210|NCT00078832|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. Anastrozole may be effective in preventing breast cancer.      PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing     breast cancer in postmenopausal women who are at increased risk for the disease.   "
171211|NCT00078845|"     RATIONALE: Amifostine may be effective in reducing pain, numbness, tingling, and other     symptoms of peripheral neuropathy.      PURPOSE: This phase II trial is studying how well amifostine works in reducing pain,     numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received     paclitaxel for solid tumors.   "
171212|NCT00078858|"     This phase I/II trial studies whether stopping cyclosporine before mycophenolate mofetil is     better at reducing the risk of life-threatening graft-versus-host disease (GVHD) than the     previous approach where mycophenolate mofetil was stopped before cyclosporine. The other     reason this study is being done because at the present time there are no curative therapies     known outside of stem cell transplantation for these types of cancer. Because of age or     underlying health status, patients may have a higher likelihood of experiencing harm from a     conventional blood stem cell transplant. This study tests whether this new blood stem cell     transplant method can be made safer by changing the order and length of time that immune     suppressing drugs are given after transplant.   "
171213|NCT00078897|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Selenium may be effective in preventing the recurrence     of adenomatous colorectal polyps.      PURPOSE: This randomized phase III trial is studying selenium to see how well it works in     preventing the recurrence of polyps in patients with adenomatous colorectal polyps.   "
171262|NCT00079573|"     This study will compare the safety and effectiveness of three popular weight loss plans.     These plans will be compared with the USDA Dietary Guidelines.   "
171215|NCT00078923|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent or delay the     development of early cancer. Soy isoflavones may be effective in delaying the development of     early prostate cancer.      PURPOSE: This randomized phase II trial is studying different regimens of soy isoflavones to     compare how well they work in treating patients who are undergoing radical prostatectomy for     stage I or stage II prostate cancer (adenocarcinoma).   "
171225|NCT00079066|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Best     supportive care is the use of drugs and other treatments to improve the quality of life of     patients. Combining cetuximab with best supportive care may slow the growth of the tumor and     help patients live longer and more comfortably. It is not yet known whether cetuximab     combined with best supportive care is more effective than best supportive care alone in     treating metastatic epidermal growth factor receptor-positive colorectal cancer.      PURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to     see how well they work compared to best supportive care alone in treating patients with     metastatic epidermal growth factor receptor-positive colorectal cancer.   "
171216|NCT00078949|"     RATIONALE: Drugs used in chemotherapy, such as dexamethasone, cisplatin, gemcitabine, and     cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or     die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to     give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies,     such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing     substances to them without harming normal cells. Giving rituximab as maintenance therapy     after stem cell transplantation may kill any remaining cancer cells. It is not yet known     which salvage chemotherapy regimen is more effective before autologous stem cell     transplantation in treating relapsed or refractory non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying salvage chemotherapy using     dexamethasone, cisplatin, and gemcitabine to see how well it works compared to dexamethasone,     cisplatin, and cytarabine given before autologous stem cell transplantation in treating     patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. This trial also is     studying giving rituximab as maintenance therapy to see how well it works compared to no     further therapy after stem cell transplantation. Rituximab was added to both salvage     treatment arms for CD20+ patients in a protocol amendment in 2005.   "
171217|NCT00078962|"     This phase I trial is studying the side effects and best dose of GTI-2040 and gemcitabine in     treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy,     such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop     growing or die. GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary     for their growth and by making tumor cells more sensitive to gemcitabine   "
171218|NCT00078975|"     RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways     to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill     more tumor cells by making them more sensitive to the drug.      PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine works     in treating patients with recurrent, unresectable, or metastatic pancreatic cancer.   "
171219|NCT00078988|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, thiotepa, and etoposide, work in     different ways to stop tumor cells from dividing so they stop growing or die. Combining     chemotherapy with autologous stem cell transplantation may allow the doctor to give higher     doses of chemotherapy drugs and kill more tumor cells. Isotretinoin may be effective in     preventing recurrence of glioma. It is not yet known which regimen of chemotherapy plus     autologous stem cell transplantation with or without isotretinoin is more effective in     treating recurrent high-grade glioma.      PURPOSE: This randomized phase III trial is studying high-dose chemotherapy or     intermediate-dose chemotherapy followed by autologous stem cell transplantation to see how     well it works compared to high-dose chemotherapy or intermediate-dose chemotherapy followed     by autologous stem cell transplantation and isotretinoin in treating young patients with     recurrent high-grade glioma.   "
171220|NCT00079001|"     RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain     or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known     whether treatment with zoledronate is effective in preventing bone-related events in patients     who have prostate cancer and bone metastases.      PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing     bone-related events in patients who are receiving androgen deprivation therapy for prostate     cancer and bone metastases.   "
171221|NCT00079014|"     This phase I trial is studying the side effects and best dose of 3-AP and doxorubicin in     treating patients with metastatic or refractory solid tumors. Drugs used in chemotherapy,     such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop     growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for     tumor cell growth and may help doxorubicin kill more cancer cells by making them more     sensitive to the drug.   "
171222|NCT00079027|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping the cells from     dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and     keeping chemotherapy drugs near the tumor. It is not yet known whether doxorubicin is more     effective with or without chemoembolization in treating unresectable hepatocellular carcinoma     (liver cancer).      PURPOSE: This randomized phase III trial is studying doxorubicin given by infusion to see how     well it works compared to doxorubicin given by chemoembolization in treating patients with     advanced liver cancer than cannot be removed by surgery.   "
171223|NCT00079040|"     This phase II trial is studying how well giving cisplatin and etoposide together with     bevacizumab works in treating patients with previously untreated extensive-stage small cell     lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different     ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies,     such as bevacizumab, can block tumor growth in different ways. Some block the ability of     tumor cells to grow and spread. Others find tumor cells and help kill them or deliver     tumor-killing substances to them. Giving chemotherapy with a monoclonal antibody may kill     more tumor cells.   "
171224|NCT00079053|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Giving erlotinib after chemoradiotherapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of adjuvant erlotinib     when given after completing chemoradiotherapy in treating patients with locally advanced     squamous cell carcinoma (cancer) of the head and neck.   "
171263|NCT00079586|"     The purpose of this study is to demonstrate that in patients undergoing coronary artery     bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac     surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with     protamine reversal.   "
171913|NCT00090532|"     AG-013,958 is being studied to treat patients with Age-Related Macular Degeneration. A total     of 144 subjects may be enrolled in the trial. Subjects will be male or female at least 55     years of age with wet age-related macular degeneration.   "
171226|NCT00079079|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work     in different ways to stop tumor cells from dividing so they stop growing or die. Giving more     than one drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with either     cisplatin or carboplatin works in treating patients with locally advanced, recurrent, or     metastatic malignant salivary gland tumor (cancer).   "
171227|NCT00079092|"     RATIONALE: Thalidomide may stop the growth of malignant glioma by stopping blood flow to the     tumor. Drugs used in chemotherapy, such as procarbazine, work in different ways to stop tumor     cells from dividing so they stop growing or die. Combining thalidomide with procarbazine may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving thalidomide together with     procarbazine works in treating patients with recurrent or progressive malignant glioma.   "
171228|NCT00079105|"     RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine,     prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer     cells from dividing so they stop growing or die. Combining more than one chemotherapy drug     may kill more cancer cells.      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating     older patients with previously untreated Hodgkin's lymphoma.   "
171229|NCT00079118|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and docetaxel, work in different     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one     chemotherapy drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving irinotecan together with docetaxel     works in treating patients with refractory metastatic breast cancer.   "
171230|NCT00079131|"     This phase II trial is studying how well oblimersen works in treating patients with Merkel     cell cancer. Biological therapies, such as oblimersen, may interfere with the growth of tumor     cells and slow the growth of Merkel cell carcinoma (skin cancer).   "
171231|NCT00079144|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Treating a     person's lymphocytes in the laboratory and reinfusing them may replace immune cells destroyed     by chemotherapy. Vaccines made from peptides may make the body build an immune response to     kill tumor cells. Giving a vaccine with Montanide ISA-51 may cause a stronger immune response     and kill more tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill tumor     cells.      PURPOSE: This phase II trial is studying how well lymphocyte-depleting nonmyeloablative (not     damaging to bone marrow) chemotherapy followed by autologous lymphocyte infusion, peptide     vaccine plus Montanide ISA-51, and interleukin-2 works in treating patients with metastatic     melanoma.   "
171232|NCT00079157|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving a     vaccine with Montanide ISA-51 and sargramostim may cause a stronger immune response and kill     more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy     when given together with Montanide ISA-51 and sargramostim in treating patients with stage IV     breast cancer.   "
171233|NCT00079170|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. It is not yet known whether garlic     supplements affect the ability of docetaxel to kill tumor cells.      PURPOSE: This clinical trial is studying how well giving docetaxel together with garlic works     in treating patients with locally advanced or metastatic breast cancer.   "
171234|NCT00079183|"     This phase II trial studies the side effects and how well sirolimus works as secondary     therapy in treating patients with chronic graft-versus-host disease (GVHD) that did not     respond to prior treatment. Sirolimus may be an effective treatment for chronic GVHD   "
171235|NCT00079222|"     RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing     fungal infections in patients who are undergoing allogeneic stem cell transplantation.      PURPOSE: This randomized clinical trial is studying voriconazole to see how well it works     compared to itraconazole in preventing fungal infections in patients who are undergoing     allogeneic hematopoietic stem cell transplantation.   "
171236|NCT00079235|"     This phase II trial is studying how well CCI-779 works in treating patients with stage IIIB     non small cell lung cancer (with pleural effusion) or stage IV non-small cell lung cancer.     Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from     dividing so they stop growing or die. CCI-779 may also stop the growth of tumor cells by     blocking the enzymes necessary for their growth.   "
171237|NCT00079248|"     RATIONALE: Hormone replacement therapy may be effective in relieving symptoms of menopause,     such as hot flashes, night sweats, and vaginal dryness, without causing a recurrence of     breast cancer.      PURPOSE: This randomized clinical trial is studying hormone replacement therapy to see how     well it works in relieving symptoms of menopause in postmenopausal women with previous stage     I or stage II breast cancer.   "
171238|NCT00079261|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine,     prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so     they stop growing or die. Combining more than one chemotherapy drug may kill more cancer     cells.      PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together     with gemcitabine to see how well it works compared to giving combination chemotherapy alone     in treating patients with previously untreated aggressive stage II, stage III, or stage IV     non-Hodgkin's lymphoma.   "
179520|NCT00185068|"     Effect of increasing doses of olmesartan medoxomil and olmesartan     medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension   "
171239|NCT00079274|"     This randomized phase III trial was originally designed to compare three different     combination chemotherapy regimens to see how well they work. As of September 1, 2004, the     study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms     which were the same as the first 3 but with cetuximab) in treating patients who have     undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan     hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to     stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as     cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to     them without harming normal cells. Combining more than one chemotherapy drug with monoclonal     antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not     known at the time this study was developed which combination chemotherapy regimen is more     effective after surgery in treating colon cancer. This study had several key changes, based     on the results of other phase III trials. As of 6/1/2005, patients no longer received     irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on     arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C     and F who had not gotten to irinotecan continued on arms A and D, respectively. As of     8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or     KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm     A and arm D. Patients on arm G were treated per physician discretion and followed for disease     and survival status. KRAS was determined in a central laboratory and was process for all     patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus     on patients having wild-type KRAS tumors. All modifications were approved by the Central     Institution Review Board, local Institutional Review Boards, NCI, and the NCCTG Data Safety     Monitoring Board.   "
171240|NCT00079287|"     RATIONALE: Drugs used in chemotherapy, such as vinorelbine, gemcitabine, docetaxel,     paclitaxel, and carboplatin, work in different ways to stop tumor cells from dividing so they     stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet     known which combination chemotherapy regimen is more effective in treating non-small cell     lung cancer.      PURPOSE: This randomized phase III trial is studying how well giving vinorelbine together     with gemcitabine and docetaxel works compared to giving paclitaxel together with carboplatin     in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.   "
171241|NCT00079300|"     RATIONALE: Biological therapies, such as imiquimod cream, work in different ways to stimulate     the immune system and stop tumor cells from growing.      PURPOSE: This randomized phase I trial is studying how well imiquimod cream works in treating     patients with basal cell skin cancer.   "
171242|NCT00079313|"     This study will evaluate the safety and effectiveness of imatinib (Gleevec(Registered     Trademark)) in patients with chronic myelomonocytic leukemia (CMML) and atypical chronic     myelogenous leukemia (CML). These conditions cause uncontrolled growth of malignant     (cancerous) cells in the bone marrow that prevents the bone marrow from functioning normally     in producing blood cells. The cancer cells also can spill over into the blood and invade     other organs of the body. Imatinib has been approved by the Food and Drug Administration for     treating chronic myelogenous leukemia, which has characteristics similar to atypical CML and     to CMML, and data from other research suggests this drug may be able to produce a remission     in forms of leukemia other than CML.      Patients over 18 years of age with atypical CML or CMML may be eligible for this study.     Candidates are screened with a medical history and physical examination, blood tests,     electrocardiogram, chest x-ray, and bone marrow aspiration and biopsy (removal of a small     piece of bone marrow tissue through a needle inserted into the hip bone).      Participants take imatinib capsules once a day for 2 years. If at any time during the study     the patient's blood counts begin to rise, disease symptoms develop, or the disease has     progressed, the dose of imatinib is increased each week until the disease progression is     stopped. Any patient whose disease does not response to treatment after 6 weeks of increased     dosing and 30 days at the maximum daily dose of 800 mg is taken off the study and referred     for different treatment.      Patients are seen by their referring physician every week for the first 4 weeks of the study,     every other week for the next 8 weeks, and then monthly until the study is completed. At each     visit, blood is drawn to monitor for drug side effects and response to therapy. In addition,     patients come to the NIH Clinical Center every 3 months for a complete history and physical     examination and for a bone marrow aspiration and biopsy every 6 months to assess the effect     of treatment on bone marrow cells.      Patients who leave the study before 2 years are followed with laboratory monitoring for 6     months after stopping imatinib; those who remain on the drug for the full 2 years are     monitored for 1 year after stopping the drug.   "
171243|NCT00079326|"     This phase II trial is studying how well giving trastuzumab together with ixabepilone works     in treating women with HER2-positive metastatic breast cancer. Monoclonal antibodies, such as     trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances     to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone, work     in different ways to stop tumor cells from dividing so they stop growing or die. Combining     trastuzumab with ixabepilone may kill more tumor cells.   "
171244|NCT00079339|"     Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their     growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may make     tumor cells more sensitive to radiation therapy. Combining tipifarnib with radiation therapy     may kill more tumor cells. This phase I/II trial is studying the side effects and best dose     of tipifarnib to see how well it works when given together with radiation therapy in treating     young patients with newly diagnosed brain stem glioma. (Phase I closed to accrual as of     1/19/06)   "
171245|NCT00079352|"     This phase I trial is studying the side effects and best dose of flavopiridol when given     together with gemcitabine and irinotecan in treating patients with unresectable or metastatic     solid tumors. Drugs used in chemotherapy, such as flavopiridol, gemcitabine, and irinotecan,     work in different ways to stop tumor cells from dividing so they stop growing or die.     Combining more than one drug may kill more tumor cells   "
171246|NCT00079365|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and gemcitabine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Fluorouracil may make the tumor cells     more sensitive to radiation therapy. Brachytherapy uses radioactive material, such as     phosphorus P32, placed directly into or near a tumor to kill tumor cells. Combining     chemotherapy and external-beam radiation therapy with brachytherapy may kill more tumor     cells.      PURPOSE: This randomized clinical trial is studying fluorouracil, gemcitabine, external-beam     radiation therapy, and brachytherapy using phosphorus P32 to see how well they work compared     to fluorouracil, gemcitabine, and external-beam radiation therapy in treating patients with     locally or regionally advanced unresectable adenocarcinoma of the pancreas (pancreatic     cancer).   "
171247|NCT00079378|"     This phase I trial is studying the side effects and best dose of decitabine and valproic acid     in treating patients with refractory or relapsed acute myeloid leukemia or previously treated     chronic lymphocytic leukemia or small lymphocytic leukemia. Drugs used in chemotherapy, such     as decitabine, work in different ways to stop cancer cells from dividing so they stop growing     or die. Valproic acid may stop the growth of cancer cells by blocking the enzymes necessary     for their growth. Combining decitabine with valproic acid may kill more cancer cells.   "
171264|NCT00079599|"     Patients with AIDS may develop a deficiency of the micronutrient carnitine and such a     deficiency may contribute to fatigue in these patients. This study will determine whether     carnitine supplementation will improve fatigue and related symptoms in carnitine-deficient     patients with AIDS.   "
171265|NCT00079612|"     The purpose of the study is to:        -  Find out if BAY 43-9006 prevents the growth of tumors        -  For patients who have stable cancer status after 3 months of treatment if it is safer          and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at          that time.        -  Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY          43-9006 (sorafenib) in the treatment of advanced refractory cancers.        -  Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some          patients.   "
171266|NCT00079625|"     This Phase 1 trial will investigate the safety of a modified stem cell transplant procedure     for treating advanced breast cancer. Patients with cancers can sometimes benefit greatly from     transplants of stem cells (cells produced by the bone marrow that mature into blood cells).     In addition to producing new bone marrow and restoring normal blood production and immunity,     the donated cells fight any residual tumor cells that might have remained in the body, in     what is called a graft-versus-tumor effect. However, severe problems, or sometimes even     death, may follow these transplants as a result of the high-dose chemotherapy and radiation     that accompany the procedure. Also, donated immune cells called lymphocytes, or T cells,     sometimes attack healthy tissues in a reaction called graft-versus-host-disease (GVHD),     damaging organs such as the liver, intestines and skin. This study will use the following     strategies to try to reduce these risks:        -  Induction chemotherapy to reduce patients' immunity in an attempt to prevent rejection          of the donated stem cells        -  Reduced-intensity conditioning chemotherapy that is easier for the body to tolerate and          involves a shorter period of complete immune suppression        -  Removal of lymphocytes from the donor stem cells for transfusion in small quantities at          monthly intervals following the stem cell transplant to reduce the risk of GVHD        -  Transplant of specific lymphocytes called Th2/Tc2 cells that may increase the percentage          of donor stem cells accepted by the patient without significantly increasing GVHD      Patients between 18 and 75 years of age with advanced (stage IV) breast cancer that does not     respond to standard therapy may be eligible for this study. Candidates are screened with a     medical history, physical and dental examinations, x-ray studies and bone marrow biopsies to     evaluate disease status, blood and urine tests (including a blood test for genetic match with     the donor), and lung and heart function tests.      Participants have a central venous line (large plastic tube) placed into a major vein. This     tube stays in the body during the entire treatment period for infusing the donated stem cells     and T lymphocytes, giving medications, including chemotherapy and other drugs, antibiotics,     and blood transfusions, and withdrawing blood samples. Treatment starts with induction     chemotherapy, in which patients receive one or two cycles of the anti-cancer drugs     fludarabine and cyclophosphamide. (One cycle consists of 4 days on drug therapy followed by a     17-day rest period.) G-CSF, a drug that boosts white cell production, is also given to reduce     the risk of infection. Several days before the transplant procedure, patients begin     conditioning chemotherapy with higher doses of cyclophosphamide and fludarabine. Three days     after the conditioning therapy is completed, the stem cells are infused. To help prevent both     rejection of the donor stem cells and GVHD, patients receive cyclosporine (first by vein and     later by mouth) for several weeks after the transplant. Infusions of donor lymphocytes begin     about 6 weeks after the transplant to boost the immune system and enhance the     graft-versus-tumor effect.      Patients may leave the hospital when they are able to eat and drink, have no fever or     infection, and have a normal or near-normal white cell count. They return for follow-up     visits twice a week for the first 100 days after the transplant, then every 3 months, then 6     months and then yearly for at least 5 years post-transplant. The visits include a medical     history, physical examination, and blood draws, as well as disease staging with CT scans     every month for the first 6 months.   "
171267|NCT00079638|"     The purpose of this study is to evaluate the effectiveness of first-line treatment using     Niaspan (an extended release version of niacin) and statins versus other drugs that lower     lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are     a class of medication that is often prescribed to patients who need to lower their     cholesterol levels.   "
171268|NCT00079651|"     This study will determine whether montessori-based activities can help older adults with     dementia become more responsive to others.   "
171248|NCT00079391|"     This study will evaluate the safety and effectiveness of stem cell transplantation in which     the donor's T cells (a type of lymphocyte, or white blood cell) are removed and then added     back. Certain patients with bone marrow malignancies undergo transplantation of donated stem     cells to generate new and normally functioning bone marrow. However, T-cells from the donor     may see the patient's cells as foreign and mount an immune response to reject them, causing     what is called graft-versus-host-disease (GVHD). Therefore, in this protocol, T-cells are     removed from the donor cells to prevent this complication. However, because T-cells are     important in fighting viral infections as well as any remaining malignant cells (called     graft-versus-leukemia effect), the donor T-cells are given to the patient (added back) at a     later time after the transplant when they can provide needed immunity with less risk of     causing GVHD.      Patients between 10 and 55 years of age with acute or chronic leukemia, myelodysplastic     syndrome, or myeloproliferative syndrome may be eligible for this study. Prospective     participants and their donors are screened with a medical history and physical examination,     blood tests (including a test to match for genetic compatibility), breathing tests, chest and     sinus x-rays, and tests of heart function. They also undergo a bone marrow biopsy and     aspiration. For this procedure, done under local anesthetic, about a tablespoon of bone     marrow is withdrawn through a needle inserted into the hipbone.      They undergo apheresis to collect lymphocytes for research studies. This procedure involves     collecting blood through a needle in the arm, similar to donating a unit of blood. The     lymphocytes are then separated and removed by a cell separator machine, and the rest of the     blood is returned through a needle in the other arm.      Before treatment begins, patients have a central intravenous line (flexible plastic tube)     placed in a vein in the chest. This line remains in place during the stem cell transplant and     recovery period for drawing and transfusing blood, giving medications, and infusing the     donated cells. Preparation for the transfusion includes high-dose radiation and chemotherapy.     Patients undergo total body irradiation in 8 doses given in two 30-minute sessions a day for     4 days. Eight days before the transplant, they begin taking fludarabine, and 3 days before     the procedure they start cyclophosphamide.   "
171249|NCT00079404|"     This phase I trial is studying the side effects and best dose of     17-N-allylamino-17-demethoxygeldanamycin in treating young patients with relapsed or     refractory solid tumors or leukemia. Drugs used in chemotherapy, such as     17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop cancer cells from     dividing so they stop growing or die.   "
171250|NCT00079417|"     This phase III trial is studying how well giving carboplatin and vincristine together with     standard local ophthalmic therapy works in treating children with intraocular retinoblastoma.     Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to     stop tumor tumor from dividing so they stop growing or die. It is not yet known whether     neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in     treating intraocular retinoblastoma.   "
171251|NCT00079430|"     This phase I trial is studying the side effects and best dose of adjuvant intraperitoneal     carboplatin when given together with paclitaxel and bevacizumab in treating patients who have     undergone debulking surgery for stage II , stage III, or stage IV ovarian epithelial, primary     peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and     paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or     die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of     tumor cells by blocking blood flow to the tumor. It is not yet known whether carboplatin,     paclitaxel, and bevacizumab are more effective than carboplatin and paclitaxel in treating     ovarian epithelial or primary peritoneal cancer, or fallopian tube cancer.   "
171252|NCT00079443|"     This phase I/II trial is studying the best dose of FR901228 when given together with     rituximab and fludarabine and to see how well FR901228 works alone in treating patients with     relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy,     such as FR901228 and fludarabine, work in different ways to stop cancer cells from dividing     so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer     cells and either kill them or deliver cancer-killing substances to them without harming     normal cells. Rituximab may increase the effectiveness of chemotherapy drugs by making cancer     cells more sensitive to the drugs.   "
171253|NCT00079456|"     This phase II trial is studying how well temsirolimus works in treating patients with     relapsed or refractory multiple myeloma. Drugs used in chemotherapy such as temsirolimus work     in different ways to stop cancer cells from dividing so they stop growing or die.   "
171254|NCT00079469|"     RATIONALE: Contingency management is a behavioral treatment approach that provides immediate     rewards for positive change in behavior such as quitting smoking. In this protocol,     contingency management will be in the form of a cash reward. A smoking cessation     (stop-smoking) program that combines contingency management with bupropion and counseling may     be effective in helping cancer survivors stop smoking.      PURPOSE: Randomized clinical trial to compare the effectiveness of bupropion and counseling     with or without contingency management in helping cancer survivors stop smoking.   "
171255|NCT00079482|"     The purpose of the study is to determine whether CEP-701 given in sequence with induction     chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML)     who achieve a second complete remission (CR).   "
171256|NCT00079495|"     We are studying this investigational drug treatment, comparing it with placebo, to evaluate     whether it is effective in reducing the number of MRI lesions with a minimum number of side     effects. The investigational drug will be administered in the clinic weekly for 5 injections     (induction phase) then monthly for 8 additional injections (maintenance phase).      Approximately 150 male and female patients (100 active and 50 placebo), aged 18 to 55 years,     with relapsing MS and at least one but no more than 10 total Gd-enhancing lesions on cranial     MRI scans during the run-in phase will be randomized into this study.   "
171257|NCT00079508|"     The purpose of this study is to demonstrate that in patients with heparin-induced     thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type     II undergoing cardiac surgery on cardiopulmonary bypass (CPB), Angiomax is a safe and     effective anticoagulant.   "
171258|NCT00079521|"     This study will evaluate the effectiveness of therapeutic touch in treating wrist fractures     in women past menopause.   "
171259|NCT00079534|"     The purpose of this study is to determine whether individuals praying at a distance (also     known as Distant Healing) can positively affect the health of people with HIV/AIDS.   "
171260|NCT00079547|"     This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins     diet) with a high carbohydrate diet (conventional USDA diet).   "
171261|NCT00079560|"     Smoked marijuana (MJ) and dronabinol (also known as THC or by the trade name Marinol) are     used to increase appetite, food intake, and weight in patients with HIV who experience     unintended weight loss. This study will compare the effects of MJ and Marinol use in     marijuana smokers who are HIV infected.   "
171270|NCT00079677|"     The primary objective of this study is to determine whether treatment with Armodafinil     (CEP-10953) is more effective than placebo treatment for patients with residual excessive     sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring     mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version)     (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change     (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).   "
171271|NCT00079690|"     To localize and identify new genes related to variation in blood pressure (BP) responses to a     low dietary sodium intake, a high dietary sodium intake, oral potassium supplementation, and     the cold pressor test.   "
171272|NCT00079703|"     To test the hypothesis that the responsiveness of major and emerging cardiovascular disease     risk factors to changes in diet composition clusters within families depending on genetic     susceptibility factors.   "
171273|NCT00079716|"     The purpose of this study is to determine the safety and activity of SGN-40 in a weekly     dosage schedule as a single agent.   "
171274|NCT00079729|"     The purpose of this study is to help researchers use information from HIV infected     adolescents to design a directly observed therapy (DOT) program that will help adolescents     take their anti-HIV medications correctly.   "
171275|NCT00079742|"     This is a Phase II, multicenter, randomized, controlled, open-label trial of the safety and     efficacy of Nutropin AQ administered subcutaneously (SC) daily in prepubertal children with     CF and growth restriction.   "
171276|NCT00079755|"     To investigate safety and antitumor activity of SGN-30 in patients with Hodgkin's Disease and     anaplastic large cell lymphoma (ALCL).      As of March 22, 2005, interim analysis of the Hodgkin's Disease (HD) arm has been completed     per the statistical plan in the protocol. SG030-0003 is now closed to further recruitment of     HD patients.   "
171277|NCT00079768|"     This study will examine the safety and effectiveness of alemtuzumab (Campath® (Registered     Trademark)) for improving muscle strength in patients with sporadic inclusion body myositis     (s-IBM). The most common inflammatory muscle disease in people over the age of 50, s-IBM     progresses steadily, leading to severe weakness and wasting of the muscles in the arms and     legs. The cause of s-IBM is not known, but it may be an autoimmune disease, in which the     body's immune cells (white blood cells) attack and destroy parts of muscle. Alemtuzumab is a     laboratory-made antibody currently approved to treat certain leukemias. It has also been used     to treat patients with autoimmune conditions such as rheumatoid arthritis, vasculitis,     multiple sclerosis, and tissue rejection associated with transplantation. Alemtuzumab     destroys white blood cells that have a protein called CD52 on their surface and that might be     among the cells attacking muscle.      Patients with s-IBM are eligible for this study. Candidates are screened with physical and     neurological examinations, blood tests, and an electrocardiogram. Participants undergo the     following tests and procedures:        -  Campath administration: Patients are admitted to the NIH Clinical Center for 1 to 1-1/2          weeks for intravenous infusions of Campath, given every other day for a total of 4          infusions.        -  Follow-up visits after infusions: Patients are monitored for up to 1 year with periodic          blood tests, physical and neurological examinations, medical history, muscle strength          measurements, and a review of symptoms, including the ability to perform daily living          activities.        -  Lymphapheresis: Patients undergo this procedure for collecting large numbers of white          blood cells twice - once at the beginning of the study and again after 6 months. Blood          is removed through a needle in an arm vein and flows through a machine that separates it          into its components by centrifugation (spinning). The white cells and plasma are removed          and the red cells and platelets are returned to the patients through the same needle or          through another needle in the other arm.        -  Muscle biopsy: Muscle biopsies are done in the operating room under local anesthetic. A          small incision is made in the thigh or upper arm and a small piece of muscle is removed.          Biopsies are done at the beginning of the study and again after 6 months.   "
171278|NCT00079781|"     The RNS® System is intended to treat patients with medically refractory (hard to treat)     epilepsy. The RNS® System Feasibility study is designed to demonstrate safety and evidence of     effectiveness of the RNS® System to support the commencement of a pivotal clinical     investigation.   "
171279|NCT00079794|"     The purpose of this study it to determine whether supplemental treatment with Iscar improves     immune function and quality of life among Stage IV non-small cell lung carcinoma patients     receiving conventional chemotherapy. Iscar is an herbal medicine made from the total plant     extract of mistletoe. this preparation is already in use in Europe and its use in the US is     likely to increase as cancer patients continue to seek alternative therapies.   "
171280|NCT00079807|"     HIV is associated with painful peripheral neuropathy. Disability is often significant.     Alpha-Lipoic Acid's antioxidant properties may have benefit in this condition.   "
171299|NCT00080054|"     The purpose of this study is to find out about the safety of adding the investigational drug     motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with     malignant glioma. Secondly, the study will determine how many patients will respond to this     treatment.   "
171317|NCT00080301|"     The purpose of this clinical research study is to learn if BMS-247550 added to the approved     therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth     of the cancer in women with metastatic breast cancer who are resistant to taxane and received     anthracycline chemotherapy. The safety of this treatment will also be studied.   "
171318|NCT00080314|"     The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus     placebo in patients with bipolar depression.   "
171319|NCT00080327|"     A study to evaluate three doses of aripiprazole versus placebo in patients with an acute     episode of schizophrenia   "
171281|NCT00079820|"     The purpose of this study is to gather information on the safety and the effectiveness of an     investigational vaccine for the prevention of smallpox disease. Smallpox was one of the major     causes of death and sickness through the first half of the 20th century, but a global program     of smallpox eradication resulted in the elimination of the natural disease. The last cases of     smallpox in the United States occurred in 1949 in Texas. Today, only laboratory workers who     work with smallpox-related viruses, military personnel, and health care workers are     vaccinated.      Historically, individuals in the US were vaccinated with a product such as Dryvax®, which     contains the virus vaccinia in the same family as smallpox. This virus could promote immunity     to smallpox, but not produce the disease itself. Although effective, these vaccines are not     safe to use in people with atopic dermatitis (eczema, allergic immune response to allergens),     children less than 1 year of age, and people with a compromised immune system, occurring in     certain diseases (HIV positive individuals and AIDS), and following treatment with certain     types of drugs. It is important to find a safe vaccine that can be used to protect people who     cannot receive routine vaccinia-based smallpox vaccine.      The vaccine in this study is known as Modified Vaccinia Ankara or MVA vaccine. It is the     objective of this study to find out if MVA vaccine is safe and effective in providing     immunity to smallpox. The effectiveness of this vaccine will be measured in two ways. The     first way is to find out if there are specific antibodies in your blood following MVA     vaccination. Antibodies are chemicals your body produces to fight smallpox virus.      The second way is to see whether or not there is a typical skin reaction following     vaccination with a traditional smallpox vaccine, given about three months after vaccination     with the MVA vaccine. The typical reaction in an unvaccinated person to smallpox vaccine is     formation of a blister or pox which occurs at the site of vaccination. In a person with     immunity to smallpox the skin reaction is much less, and typically consists of a little     swelling at the site of vaccination.   "
171282|NCT00079833|"     This research study will determine if esomeprazole, when administered twice daily at 40, 80,     or 120 mg doses, can control excessive stomach acid secretion.   "
171283|NCT00079846|"     The purpose of this study is to determine if implitapide, used in conjunction with other     lipid-lowering therapies, is safe and effective when compared to placebo in lowering     low-density lipoprotein cholesterol (LDL-C) in patients with homozygous familial     hypercholesterolemia (HoFH).   "
171284|NCT00079859|"     The purpose of this study is to determine if implitapide, used in conjunction with other     lipid-lowering therapies, is safe and effective when compared to placebo in lowering     low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial     hypercholesterolemia (HeFH).   "
171285|NCT00079872|"     In this study, patients will receive either pemetrexed plus irinotecan or 5-fluorouracil     (5-FU), leucovorin, and irinotecan.      The purposes of this study are to determine:        -  How pemetrexed plus irinotecan compares with 5-FU, leucovorin, and irinotecan in terms          of efficacy.        -  The safety of pemetrexed plus irinotecan and any side effects that might be associated          with it as compared with 5-FU, leucovorin, and irinotecan.        -  Whether pemetrexed can help patients with colorectal cancer.   "
171286|NCT00079885|"     To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment     of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the     study will be the clinical response in the clinically evaluable population and the clinical     response in the clinical modified intent-to-treat population at the TOC visit. The primary     efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If     tigecycline is found to be noninferior, the analyses will determine whether tigecycline is     statistically better than levofloxacin.   "
171287|NCT00079898|"     The purpose of this study is to use brain imaging technology to examine the way acupuncture     affects brain function.   "
171288|NCT00079911|"     This clinical research study will be an international trial evaluating the safety and     effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression     of repeated genital herpes infections in HIV-infected subjects with CD4+ count <100     cells/mm3.   "
171289|NCT00079924|"     Effects of Teriparatide in Postmenopausal Women Previously Treated with Alendronate or     Raloxifene.   "
171290|NCT00079937|"     A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key     role in generating asthma attacks. In patients with allergies, there is an exaggerated     production of IgE in response to specific substances such as pollens. Omalizumab is a new     drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against     asthma attacks in children with allergic asthma.   "
171291|NCT00079950|"     The purpose of this study is to evaluate the safety and efficacy of Pegamotecan     (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.   "
171292|NCT00079963|"     This randomized placebo-controlled trial will test whether supplementing with vitamins C and     E can lower markers of inflammation and oxidative stress in healthy adults. We will examine     whether one antioxidant vitamin is more effective than another, and whether gender or body     fat influence the treatment effects. We will also determine whether gender, body fat, or     menopausal status are associated with baseline concentrations of inflammation and oxidative     stress markers.   "
171293|NCT00079976|"     To evaluate the safety and efficacy of tigecycline in the treatment of selected serious     infections caused by VRE. The primary efficacy endpoint will be the clinical response for all     subjects.   "
171294|NCT00079989|"     To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected     serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii,     Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for     whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial     therapies. The primary efficacy endpoint will be the clinical response.   "
171295|NCT00080002|"     The purpose of this study is to evaluate the safety and efficacy of pegamotecan     (PEG-camptothecin) in patients with pathologically-diagnosed locally advanced or metastatic     adenocarcinoma of the stomach or gastroesophageal junction who have relapsed or progressed     following one prior chemotherapy treatment regimen.   "
171296|NCT00080015|"     This is a Phase II, open-label, multicenter, single-arm, exploratory proof of concept     study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once     every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive     disease after first-line treatment with a platinum-based regimen.   "
171297|NCT00080028|"     The purpose of this study is to evaluate the safety of adding the investigational drug     Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with     drugs called 5-FU and cisplatin in patients with advanced head and neck cancer.   "
171298|NCT00080041|"     The primary purpose of this study is to evaluate the safety, toxicities, and dosage for     investigational drug Motexafin Gadolinium administered with docetaxel to patients with     advanced solid tumors. Secondly, tumor response to the combined treatment will be evaluated.   "
171300|NCT00080067|"     This study will examine how different brain areas are involved in the perception of rhythmic     patterns and the performance of rhythmic movements. Patients with certain types of brain     diseases, such as Parkinson's disease and some types of stroke, may have difficulty     performing rhythmic movements, such as finger tapping.      Healthy, right-handed volunteers between 21 and 65 years of age may be eligible for this     study. Candidates with visual, motor or hearing problems are excluded, as are musicians and     pregnant women.      Participants will come to the National Institutes of Health (NIH) Clinical Center for up to     six sessions of functional magnetic resonance imaging (fMRI) scanning. MRI uses a strong     magnetic field and radio waves to obtain images of body organs and tissues. The scanner is a     metal cylinder surrounded by a magnetic field. During the MRI, the subject lies still for up     to 20 minutes at a time on a table in the cylinder and wears earplugs to muffle loud knocking     noises that occur with the electrical switching of the magnetic fields. He or she can     communicate with the MRI staff through a microphone at all times during the procedure.      For fMRI, images are obtained while the subject performs a task, such as hearing sounds or     moving a finger. The machine detects changes in brain movement that are involved in     performing the task. The tasks are explained, and subjects can practice them before entering     the scanner.   "
183467|NCT00245323|"     The purpose of this study is to determine if checking smoking status as a routine vital sign     increases the delivery rate of cessation counseling to adult smokers in primary care     practices.   "
171301|NCT00080080|"     The purpose of this study is to determine the antitumor activity (response rate, time to     tumor progression, survival) and safety of docetaxel in combination with talabostat in     patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior     platinum-containing regimen.   "
171302|NCT00080093|"     This study will evaluate a new program designed to increase condom use in both women and men.   "
171303|NCT00080106|"     HIV vaccines may help the immune systems of HIV infected patients better control the virus.     The goal of this study is to determine whether patients on anti-HIV medications can stop     taking those medications if they receive an HIV vaccine. While taking anti-HIV medications,     participants will receive either an HIV vaccine or a placebo. Participants will then stop     taking their anti-HIV medications and the study will compare the viral loads of participants     who received the vaccine with the viral loads of participants who received the placebo.      Primary study hypotheses: 1)The Week 12 and Week 16 post-ART interruption geometric mean     HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to     ART interruption than among participants who received placebo; 2) the time averaged area     under the curve of the log10 HIV-1 RNA copies/ml versus day function in the 16 week post-ART     interruption step will be lower among participants who received the MRK Ad5 vaccine prior to     ART interruption than among participants who receive placebo.   "
171304|NCT00080119|"     Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in     settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with     high rates of transmission of Mycobacterium tuberculosis (M.tb) to both adults and children.     Children infected with TB have a higher risk of developing severe disease than adults with     TB. The purpose of this study was to determine if the antibiotic isoniazid (INH) prevented TB     infection in infants born to HIV-infected mothers.   "
171305|NCT00080132|"     The purpose of this study is to determine if implitapide is effective in lowering     triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where     the maximum tolerable medication and diet were not sufficient.   "
171306|NCT00080145|"     This 24-week study will compare the safety and effectiveness of medication treatment alone     (risperidone or aripiprazole) to medication treatment in combination with a parent management     training program.   "
171307|NCT00080158|"     The purpose of this study is to compare the effects of three types of treatments for     depressed teenagers who have attempted suicide.   "
171308|NCT00080171|"     Knee osteoarthritis (OA) is the most common cause of disability in adults. The     Osteoarthritis Initiative (OAI): A Knee Health Study is a nationwide research study that     will help researchers gather more information about the physical changes that occur prior to     the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to     examine people who have knee OA or are at high risk for knee OA; information will be used to     better understand how to prevent and treat knee OA.   "
171309|NCT00080184|"     The purpose of this study is to determine whether a new form of brainwave biofeedback is     effective in the treatment of fibromyalgia.   "
171310|NCT00080197|"     The purpose of this study is to determine if E7070 is an efficacious, safe, and tolerable     treatment for patients with metastatic breast cancer who have failed, or could not tolerate,     prior treatments with an anthracycline, a taxane, and capecitabine.   "
171311|NCT00080210|"     This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous     doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects     must wash out of any uric acid-lowering agents for one week before being dosed, and must     refrain from using such agents throughout the study.   "
171312|NCT00080223|"     To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with     pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).   "
171313|NCT00080236|"     The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing     liver damage that normally occurs when livers are transported before being transplanted and     in the immediate post-transplant period.   "
171314|NCT00080262|"     The purpose of this research study is to assess the response rate of the investigational drug     BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an     anthracycline, a taxane, and capecitabine.   "
171315|NCT00080275|"     The purpose of this 24 week study is to compare the effectiveness and safety of different     doses of Niacin ER/Simvastatin (NS) in subjects with elevated fat levels in their blood     (dyslipidemia).      At least 600 subjects with a similar medical condition will take part in this study.   "
171316|NCT00080288|"     The primary objective of this study is to determine whether treatment with Armodafinil     (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness     associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from     the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600,     and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.   "
171320|NCT00080340|"     The purpose of this study is to determine if TLK286(Telcyta) is more effective than gefitinib     (Iressa) in the treatment of non-small cell lung cancer.   "
171322|NCT00080366|"     This study will evaluate the effectiveness of 1-octanol, a substance similar to alcohol but     less intoxicating, for treating essential tremor. Essential tremor is an involuntary shaking,     usually of the hands, for which there is no satisfactory treatment. It affects about 1.4     percent of the general U.S. population, with the figure climbing to nearly 4 percent among     people over 40. Results of two previous NIH studies have shown 1-octanol to be promising as a     potential new treatment. This study will test the effectiveness of 1-octanol on essential     tremor at doses lower than those given previously.      Patients 21 years old and older with essential tremor may be eligible for this study.     Participants are admitted to the NIH Clinical Center for two treatment periods of 1 week     each, with a 1-week break at home between treatments. Before beginning treatment,     participants undergo a medical history, physical examination, blood and urine tests, and an     electrocardiogram (EKG). In addition, tremors are measured using accelerometry, a procedure     in which a small device, mounted on a piece of cardboard, is taped to the patient's hand for     about 30 minutes.      Patients are randomly assigned to one of two groups. One group takes 2 to 4 capsules of     1-octanol 3 times a day for 1 week, followed by a 1-week washout period (no treatment), and     then 2 to 4 capsules of placebo 3 times a day for 1 week. Following the same dosage schedule,     the second group takes placebo the first week, followed by the washout period and then     1-octanol treatment. Blood pressure and pulse are measured at 15, 30, and 60 minutes after     the first dose of the day and then 3 times a day each day of hospitalization, EKG and blood     draws are done every other day during hospitalization, and blood is drawn again 1 week after     the end of the study. Patients evaluate their tremor daily according to a tremor scale and     are also rated according to an alcohol intoxication scale.   "
171323|NCT00080392|"     This study will test the safety of a drug called EW-A-401 in patients with intermittent     claudication - pain and discomfort in the legs due to blockages of the arteries. The study     will also evaluate whether EW-A-401 improves blood flow to the legs. EW-A-401 contains     genetic material (DNA) that instructs the body to produce specific proteins that promote the     growth of new blood vessels and may, therefore, improve blood flow to the legs.      Patients 21 years of age and older with pain or discomfort of one or both legs due to     blockages of the arteries below the groin may be eligible for this study. Candidates are     screened with a medical history, physical examination, blood and urine tests, eye     examination, chest x-ray and CT scan of the chest, and treadmill tests. Patients who are able     to exercise more than 12 minutes on the treadmill may not enroll in the study.      Participants undergo the following procedures:        -  Muscle biopsy: On the first day of the study, patients have a muscle biopsy. This          procedure is done under local anesthesia with mild sedation. A 1-inch incision is cut          into the skin over a calf muscle and a small amount of muscle tissue is removed for          examination by a pathologist.        -  Drug treatment and tests: About 10 to 13 days after the biopsy, patients are admitted to          the NIH Clinical Center for 3 to 5 days for drug treatment and tests. They receive 10          injections of either the study drug (EW-A-401) or placebo (an inactive substance) in          each leg during a single session lasting about 1 hour. In addition, they have blood and          urine tests, complete questionnaires about their symptoms, and undergo magnetic          resonance imaging (MRI), a test that a magnetic field and radio waves to produce          detailed images of body tissues and organs. For this procedure, the patient lies on a          table that slides into the scanner (a large hollow tube) for imaging of the blood          vessels in the legs. Patients wear headphones to muffle loud knocking and thumping          sounds that occur during the scanning process.        -  30-day follow-up: Patients return to the Clinical Center three times over 30 days          following the hospital stay for a medical history, physical examination, and blood and          urine tests to assess the safety of EW-A-401.        -  Extended follow-up: Patients return to the Clinical Center at 3, 6, and 12 months after          hospitalization for a medical history and physical examination, blood and urine tests,          two treadmill tests, questionnaires about symptoms, and MRI studies, including imaging          for blood flow measurement. Blood flow to the legs is measured during MRI using large          blood pressure cuffs inflated around the legs during the scanning. The cuffs are          inflated very tightly for 5 minutes, and then a dye is injected into an arm vein to          brighten the images. Additional pictures are taken over the next 5 to 10 minutes. At two          of these follow-up visits, patients also have an eye examination, and at the 3- or          6-month visit they have a repeat muscle biopsy of the calf.      The study lasts 12 months. After 6 months, patients will be told whether they received     EW-A-401 or placebo. Because EW-A-401 is so new, patients will continue to be contacted every     year after the study is completed.   "
171324|NCT00080405|"     The purpose of this study is to characterize the clinical pharmacokinetic and pharmacodynamic     profiles of the 2 doses of VELCADE (bortezomib) for Injection. Patients who volunteer to     participate in the pharmacogenetic portion of the study, an additional blood sample will be     collected before the Cycle 1 Day 1 dose of bortezomib to assess the genotype of drug     metabolizing enzymes.   "
171325|NCT00080418|"     The purpose of this study is to determine the highest dose of Liposome Entrapped Paclitaxel     Easy to Use formulation (LEP-ETU) that can be safely administered by an intravenous infusion     to patients with advanced cancer.   "
171326|NCT00080431|"     This study will examine the safety and effectiveness of daclizumab (also called Zenapax or     anti-CD25) in reducing viral replication in patients with HIV infection. Although HAART, an     intensive anti-HIV treatment regimen, can suppress HIV in blood below the limit of detection,     it cannot completely eradicate the virus. This study will focus on the effectiveness of     daclizumab in further reducing viral replication in patients with low viral counts. The Food     and Drug Administration approved daclizumab in 1997 for preventing kidney transplant     rejection, and it has also been studied in people with an eye infection called uveitis. The     drug works by binding to a protein on T cells (white blood cells of the immune system) called     CD25. This prevents another protein, called interleukin-2 (IL-2), from binding to this site,     thus preventing a series of events that normally results in inflammation.      Patients between 18 and 65 years of age with HIV infection who have stable HIV levels at less     than 30,000 copies/mL of blood and CD4 T cell counts higher than 400 cells/cmm may be     eligible for this study. Patients who have taken drugs that affect the immune system, such as     IL-2 and interferon, in the past 5 years may not participate. Candidates are screened with a     comprehensive medical examination, including physical examination and laboratory studies.     X-rays, consultations, and biopsies are done only if medically indicated.      Participants will undergo the following tests and procedures:        -  Daclizumab therapy: Patients receive daclizumab as a 25-minute infusion through an          intravenous catheter (plastic tube placed in a vein) at the NIH Clinical Center          outpatient clinic. A total of three doses of drug are given. The first dose is given on          study day 1, the second dose is given 2 weeks later, and the third dose is given 4 weeks          later. Patients are observed for at least 1 hour after each infusion before being          discharged from the clinic.        -  Follow-up visits: Patients return to the outpatient clinic every 2 weeks while they are          on medication and then every month until 3 months after the final dose to evaluate their          infection status, response to therapy, and medication side effects. The visits include a          physical examination, blood draws, and possibly x-rays, if medically indicated.        -  Apheresis: Patients undergo apheresis, a procedure for collecting large amounts of white          blood cells, three times during the study - once before starting daclizumab therapy, 4          weeks after beginning therapy, and 12 weeks after beginning therapy. For apheresis,          blood is removed through a needle in the vein of one arm and spun in a machine that          separates it into its components. The white blood cells and plasma are removed, and the          red cells and platelets are re-infused either through the same needle or through a          needle in a vein in the other arm.   "
171327|NCT00080444|"     This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and     vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants     treated with emetogenic cancer chemotherapies that include either cisplatin,     cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when     treated with a previously administered chemotherapy regimen that is planned to be repeated     will be enrolled in this study. In the double-blind Part 1 of this study, enrolled     participants will be randomized to receive either aprepitant or standard therapy. In Part 2     of this study, enrolled participants will receive open-label aprepitant.   "
171328|NCT00080457|"     The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan     sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial     hypertension (PAH).   "
171329|NCT00080470|"     This clinical trial is being conducted to investigate the safety and effectiveness of a new     device designed to treat urinary urge incontinence in those patients who have tried and     failed two or more conservative therapies.   "
171330|NCT00080483|"     Deficiency of testosterone, growth hormone, or both hormones can result in osteoporosis. If     either hormone is replaced, the condition of the bones improves. The purpose of this study is     to determine if dual hormone treatment for men deficient in testosterone and growth hormone     improves bone structure more than testosterone treatment alone.   "
171331|NCT00080496|"     To compare the efficacy and safety of the tigecycline regimen with that of the     imipenem/cilastatin regimen in subjects with nosocomial pneumonia.   "
171332|NCT00080509|"     The purpose of this study is to determine whether a potential drug known as KOS-862 or     Epothilone D has an effect as a 2nd line treatment in non-small cell lung cancer (NSCLC)     for patients having failed one prior platinum-containing chemotherapy regimen.   "
171333|NCT00080522|"     Providing effective anti-HIV therapy in developing countries is challenging. This study will     evaluate new strategies for delivering anti-HIV medications to people in South Africa. These     strategies include using specially trained nurses to administer therapy (rather than     doctors), treating all HIV infected members of a household at the same time, and having     community members observe patients taking their medications.   "
171334|NCT00080535|"     This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating     cutaneous T-cell lymphoma in patients who have a protein called cluster of differentiation 25     (CD25) on their cancer cells. LMB-2 is a recombinant immunotoxin. It is made up of two parts:     a genetically engineered monoclonal antibody that binds to CD25, and a toxin produced by     bacteria that kills the cancer cells to which it binds. LMB-2 has killed CD25-containing     cells in laboratory experiments and has caused tumors in mice to shrink. Preliminary studies     in humans have shown some effectiveness in shrinking tumors in patients with various types of     lymph and blood cancers.      Patients 18 years of age and older with stage 1b to IV cutaneous T-cell lymphoma that has     progressed within 2 years of systemic or topical therapy and who have CD25 receptor proteins     on their cancer cells may be eligible for this study. Candidates are screened with a medical     history and physical examination, blood and urine tests, electrocardiogram (EKG),     echocardiogram, chest x-ray, computed tomography (CT) scans of the chest, abdomen and pelvis,     skin punch biopsy to evaluate tumor infiltration in the skin, and a bone marrow biopsy on     patients with stage IIa disease and higher. In addition, the patient's blood, bone marrow,     tumor, or other tissue is tested to determine the presence of CD25 on cancer cells.      Participants receive up to nine cycles of LMB-2 therapy as long as their cancer does not     worsen and they do not develop serious side effects. Each 28-day cycle consists of 30-minute     infusions of LMB-2 on cycle days 1, 3, and 5. The drug is infused through an intravenous (IV)     catheter (plastic tube placed in a vein) or a central venous line - an IV tube placed in a     large vein in the neck or chest that leads to the heart. In addition to drug therapy,     patients undergo the following procedures:      Blood draws: Blood is drawn before, during, and after each LMB-2 infusion to measure blood     levels of the drug, evaluate its effects on the cancer cells, and monitor side effects. Blood     tests are also done before and during each cycle to determine how the immune system is     interacting with the drug.      Disease evaluations: Patients undergo a careful skin examination, blood tests, chest x-ray,     and EKG before each treatment cycle and at follow-up visits. A CT scan and echocardiogram     (heart ultrasound) are done before the first cycle. Before the first and second cycles,     patients have a biopsy of the lymphoma on the skin. If the biopsy is helpful in evaluating     the disease response to LMB-2, additional biopsies may be requested prior to other cycles as     well. A nuclear medicine scan may be done, and a bone marrow biopsy may be done in patients     with stage II to IV disease. If these tests are helpful in understanding the response of the     lymphoma to treatment, they may also be repeated prior to other cycles, with the patient's     permission.      Patients are admitted to the National Institutes of Health (NIH) Clinical Center for the     first treatment cycle. Subsequent cycles are given as outpatients. If the infusions are well     tolerated, patients may return home after about one week (or possibly longer if complications     occur). After returning home, patients have blood tests done weekly by their local     physicians.   "
171354|NCT00080899|"     This phase II trial is studying how well fenretinide works in treating patients with     biochemically (rising PSA level) recurrent hormone-naïve (no previous hormone therapy)     prostate cancer. Drugs used in chemotherapy, such as fenretinide, work in different ways to     stop tumor cells from dividing so they stop growing or die   "
171335|NCT00080548|"     This study will examine and compare how the brain controls the timing of movement in healthy     volunteers and in people with schizophrenia. Previous experiments have shown that when people     are asked to look at a clock and report the time they first decide to make a movement, they     report times later than the first brain waves associated with movement appear. When they are     asked to report the time they first initiate the movement, they report times before the     muscles actually begin to move. The study may help determine how the sense of willing and     initiating an action is altered in schizophrenic patients, and how people may feel more or     less in control of their movements.      Normal volunteers and patients with schizophrenia between 18 and 65 years of age may be     eligible for this study. Control subjects must not have any neurological or psychological     disorders, and schizophrenia patients must not have any other neurological disorders.      All participants will have a medical history, physical examination, and a test to determine     their level of attention. Schizophrenia patients will be interviewed about their symptoms and     complete psychiatric rating scales. In addition, all participants will undergo the following     procedures:      Electric shock      Participants look at a clock on a computer screen whose hands revolves around the clock fast.     While they look at the clock, they are given small, non-painful electric shocks and are asked     to say when they receive the shocks, according to the clock. The shocks are repeated 40     times.      Arm movement      Participants are asked to lift their arm up off a table repeatedly, at random times, while     they look at the computer clock. This exercise is repeated a total of 80 times. Of these 80     times, participants are asked 10 times in a row to say the time they first had the desire to     move their arm, and then 10 times in a row the time they first felt that they were moving     their arm.      Electroencephalography (EEG) and Electromyography (EMG)      Participants undergo EEG and EMG during the electric shock and arm movement experiments to     measure electrical activity of the brain (EEG) and of the muscles (EMG). For EEG, electrodes     (small metal discs) are placed on the scalp with a cap, paste, or glue-like substance and the     brain waves are recorded. For EMG, electrodes are taped to the skin over the muscle.   "
171336|NCT00080574|"     This study will examine whether and how levothyroxine (Synthroid, a synthetic thyroid     hormone) affects the way the body handles other drugs. If levothyroxine does affect the     metabolism of other drugs, the dose of those medications may need to be increased to enhance     their action or decreased to avoid adverse reactions.      Patients 18 years of age and older with thyroid cancer who are participating in NIH protocol     #77-DK-0096 and are receiving long-term suppression therapy with levothyroxine may be     eligible for this study. This is not a study of thyroid cancer or of potential new drugs to     treat it. Thyroid cancer patients are being studied because their treatment regimen provides     an opportunity to study drug metabolism while patients are both on and off levothyroxine     therapy.      Participants come to the NIH Clinical Center on two occasions: once while they are regularly     taking their levothyroxine, and once while they are off the medication in preparation for     their radioactive iodide diagnostic scan for the procedures outlined below. The time interval     between the two clinic visits depends on whether the first visit is while the patient is on     or off medication. Participants are asked to fast overnight before each visit and to abstain     from certain foods and beverages for 48 to 72 hours before the visit. At each visit, patients     undergo the following procedures:        -  Medication history, limited physical examination, and blood draw for laboratory tests,          including a test to look for genes important in eliminating medications from the body.        -  Insertion of a catheter (thin plastic tube) into an arm vein for collecting blood          samples.        -  Shave skin biopsy (optional) to explore how proteins in the skin that metabolize and          transport drugs are affected by thyroid hormone. For this procedure, the skin is          cleaned, numbed with medicine, and a small sample of the top layer is removed with a          razor blade. The wound heals in 2 to 3 days.        -  Medication dosing. Participants take all of the following substances by mouth at the          same time: 1) 200 mg of caffeine, a compound commonly found in chocolate, soda/pop,          coffee, tea and non-prescription products to prevent sleep; 2) 30 mg of          dextromethorphan, a non-prescription cough suppressant; 3) 40 mg of omeprazole, a          prescription drug for heartburn and stomach ulcers; 4) 8 mg of midazolam, a prescription          drug used to cause relaxation and drowsiness; and 5) 120 mg of fexofenadine, a          non-sedating prescription antihistamine used to treat allergies.        -  Blood and urine sampling. Fifteen blood samples of about 5 mL (1 teaspoon) each are          collected through the catheter and urine is collected over the next 24 hours to          determine what happens to the test drugs in the body.      Participants may resume their normal diet 4 hours after taking the study medications.   "
171337|NCT00080587|"     This study will compare changes in atherosclerotic plaque in the coronary arteries (vessels     on the surface of the heart that supply blood to the heart) with changes in the carotid     arteries (vessels in the neck that supply blood to the brain) in patients enrolled in a     Pfizer-sponsored treatment trial for coronary artery disease. Atherosclerosis is a buildup of     fatty deposits (plaque) in arteries that can lead to blockage of the vessel, possibly     resulting in heart attack or stroke. A major question in cardiovascular disease is how     closely atherosclerotic changes in the coronary arteries correlate with changes in the     carotid artery that occur with treatment. substudy of a Pfizer.      Patients enrolled in the Pfizer trial comparing the effectiveness of the drug atorvastatin     with a combination of atorvastatin and CETP inhibitor (a drug to increase HDL cholesterol     levels) may be eligible for this substudy.      Participants undergo magnetic resonance imaging (MRI) and ultrasound of the carotid arteries     to measure the thickness of the vessels. The results are then compared with the coronary     artery images obtained as part of the patient's evaluation for the Pfizer trial.      MRI      MRI scans use a powerful magnet with an advanced computer system and radio waves to produce     accurate, detailed pictures of organs and tissues. During the scan the patient lies on a     table in a narrow cylinder containing a magnetic field, wearing earplugs to muffle loud     noises that occur with electrical switching of the magnetic fields. A medicine called     gadolinium contrast may be injected into a vein during part of the scan to brighten the     images. The scan takes about 30 to 90 minutes. An electrocardiogram (ECG) is done during the     scan to monitor the heart's electrical activity. Patients who agree to undergo another MRI     test are also imaged in a scanner that uses a stronger (3 Tesla) magnet.      Ultrasound      An echocardiogram (ultrasound of the heart) uses sound waves to image the carotid arteries. A     gel is applied to the area of the neck to be imaged and a small handheld ultrasound probe is     held against the neck to take the pictures.      Participants return after 2 years for a second set of tests.   "
171338|NCT00080600|"     OBJECTIVE: Many persons who survive poliomyelitis develop pain, weakness, and fatigue many     decades later. It is not known why some persons develop this syndrome and others do not. One     possibility is that polio caused subclinical damage to the motor cortex. Autopsies in some     polio patients have found damage to the brainstem and motor cortex as well as to spinal motor     neurons. Alternatively, polio may have spared the motor cortex, but the cortex reorganized in     different ways to compensate for the loss of spinal motor neurons. This study will first     assess the integrity of central motor pathways in polio survivors with and without postpolio     syndrome. The second goal will be to investigate differences in the intracortical mechanisms     for controlling muscles affected and unaffected by polio.      STUDY POPULATION: 60 patients who survived polio in childhood. Only patients with an     unequivocal history of polio will be referred to this study. Half of the patients will have     the post-polio syndrome. 30 normal volunteers, aged 21-75.      DESIGN: Patients will be screened at the collaborating institution, the Uniformed Services     University of the Health Sciences, which will also perform sensory evoked potential testing     and MRI. At NIH, motor evoked potentials will be elicited from all four limbs using     transcranial magnetic stimulation to assess central motor conduction time and threshold.     Intracortical facilitation will be used to assess using paired-pulse magnetic stimulation.     Two muscles will be tested in each patient, one affected by polio and one unaffected by     polio. In the affected muscle, intracortical facilitation will be assessed again after     exercises it until it fatigues.      OUTCOME PARAMETERS: Cortical thresholds and central motor conduction times to all four limbs     will be measured in patients and compared to normal subjects. The mean intracortical     facilitation at rest will be compared in affected and unaffected muscles in polio patients     with and without post-polio syndrome.   "
171339|NCT00080613|"     RATIONALE: Estrogen and progesterone can stimulate the growth of breast cancer cells. Hormone     therapy using exemestane may fight breast cancer by reducing the production of estrogen and     progesterone. Giving hormone therapy before surgery may shrink the tumor so it can be removed     with breast-conserving surgery. Giving hormone therapy after surgery may kill any remaining     tumor cells.      PURPOSE: Phase II trial to study the effectiveness of neoadjuvant and adjuvant exemestane in     treating postmenopausal women who have locally advancedestrogen and/or progesterone     receptor-positive breast cancer.   "
171340|NCT00080626|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before     surgery may shrink the tumor so that it can be removed.      PURPOSE: This phase II trial is studying how well neoadjuvant docetaxel works in treating     women who are undergoing surgery for breast cancer.   "
171341|NCT00080639|"     RATIONALE: Measuring levels of CA 125 in blood samples of women who have a high risk of     developing ovarian cancer may help doctors detect cancer early and plan more effective     treatment.      PURPOSE: This phase II trial is studying CA-125 levels in screening for cancer in women who     are at high risk of developing ovarian cancer.   "
171342|NCT00080665|"     RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor     cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of     tumor cells by blocking the enzymes necessary for their growth. Giving docetaxel with     imatinib mesylate may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when     given together with imatinib mesylate in treating patients with locally advanced or     metastatic breast cancer.   "
171343|NCT00080678|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth     of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with     imatinib mesylate may be effective treatment for androgen-independent prostate cancer and     bone metastases.      PURPOSE: This randomized phase II trial is studying docetaxel and imatinib mesylate to see     how well they work compared to docetaxel alone in treating patients with androgen-independent     prostate cancer and bone metastases.   "
171344|NCT00080743|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of     estrogen by the tumor cells. Combining gefitinib with tamoxifen may be effective in killing     tumor cells that have become resistant (stopped responding) to tamoxifen.      PURPOSE: This randomized phase II trial is studying how well giving gefitinib together with     tamoxifen works compared to gefitinib alone in treating patients with metastatic breast     cancer that has stopped responding to tamoxifen.   "
171345|NCT00080756|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and     testosterone (given to replace hormones suppressed by deslorelin) may be effective in     preventing breast cancer in at-risk women.      PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol     and testosterone works in preventing breast cancer in premenopausal women who are at high     risk for this disease.   "
171346|NCT00080782|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop     tumor cells from dividing so they stop growing or die. Strontium-89 may relieve bone pain     caused by prostate cancer. Celecoxib may stop the growth of cancer by stopping blood flow to     the tumor and by blocking the enzymes necessary for tumor cell growth. Combining doxorubicin     and strontium-89 with celecoxib may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying celecoxib together with doxorubicin and     strontium-89 to see how well they work compared to doxorubicin and strontium-89 alone in     treating patients with progressive androgen-independent prostate cancer and bone metastases.   "
171347|NCT00080795|"     RATIONALE: Drugs used in chemotherapy, such as ifosfamide, doxorubicin, gemcitabine, and     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than one drug, and giving them before surgery, may shrink the tumor so     that it can be removed.      PURPOSE: This phase II trial is studying how well neoadjuvant combination chemotherapy works     in treating patients undergoing radical cystectomy for locally advanced carcinoma of the     urothelium.   "
171348|NCT00080808|"     RATIONALE: Nerve-sparing radical prostatectomy with nerve grafting followed by standard     therapies for erectile dysfunction may be effective in helping patients with prostate cancer     improve sexual satisfaction and quality of life. It is not yet known whether erectile     dysfunction therapy and nerve-sparing prostatectomy are more effective with or without nerve     grafting.      PURPOSE: This randomized phase II trial is studying nerve grafting and standard therapy to     see how well they work compared to standard therapy alone in treating erectile dysfunction in     patients undergoing nerve-sparing radical prostatectomy for localized prostate cancer.   "
171349|NCT00080834|"     RATIONALE: Drugs used in chemotherapy, such as DJ-927, work in different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well DJ-927 works as second-line therapy in     treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma     (cancer).   "
171350|NCT00080847|"     This randomized phase II trial is studying rituximab and combination chemotherapy to see how     well they work compared to oblimersen, rituximab, and combination chemotherapy in treating     patients with advanced diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies,     such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing     substances to them without harming normal cells. Drugs used in chemotherapy, such as     cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop     cancer cells from dividing so they stop growing or die. Oblimersen may increase the     effectiveness of anticancer drugs by making cancer cells more sensitive to the drugs.     Combining rituximab and combination chemotherapy with oblimersen may kill more cancer cells   "
171351|NCT00080860|"     RATIONALE: Sentinel lymph node biopsy and gene expression profiling of the primary breast     tumor may help determine if tumor cells have spread to the axillary lymph nodes and help     doctors plan more effective surgery for breast cancer.      PURPOSE: This clinical trial is studying how well sentinel lymph node biopsy and primary     tumor gene expression profiling work in finding lymph node metastases in women who have     received neoadjuvant therapy for stage II, stage III, or stage IV breast cancer.   "
171352|NCT00080873|"     RATIONALE: Traumeel® S (a mouth rinse) may be effective in preventing or decreasing the     severity of oral mucositis caused by chemotherapy in young patients who are undergoing stem     cell transplantation.      PURPOSE: This randomized clinical trial is studying how well Traumeel® S works in preventing     or treating mucositis in young patients who are receiving chemotherapy with or without     total-body irradiation before undergoing stem cell transplantation.   "
171353|NCT00080886|"     RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different     ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and     combination chemotherapy with autologous stem cell transplantation may allow the doctor to     give higher doses of chemotherapy drugs and kill more cancer cells.      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination     chemotherapy followed by autologous hematopoietic stem cell transplantation in treating     patients who have B-cell non-Hodgkin's lymphoma.   "
171355|NCT00074516|"     This study will test the effectiveness of a combination of anti-rejection medicines in     preventing complications typically seen in cystinosis patients undergoing kidney transplants.     Cystinosis is a rare disease affecting children that causes growth retardation and kidney     failure. Kidney transplant is the standard treatment for kidney failure in these patients,     followed by immunosuppression to prevent organ rejection. The standard drug regimen for     immunosuppression includes steroids, which can lead to other serious complications. This     study will look at combination therapy that does not include steroids.      Patients 7 years of age and older with cystinosis who are candidates for a kidney transplant     at the National Institutes of Health Clinical Center may be eligible for this 5-year study.     Candidates will be screened with a medical history, physical examination, and blood tests.      Participants will undergo the following tests and procedures:        1. Kidney transplant: Patients undergo kidney transplant surgery under general anesthesia.        2. Central line placement: A large intravenous catheter (plastic tube, or IV line) is          placed in a vein in the chest or neck under local anesthesia before the transplant          surgery. The line remains in place for some time during the hospitalization to          administer immunosuppressive medications, antibiotics, and blood, if needed. The line is          also used to collect blood samples.        3. Leukapheresis: This procedure for collecting white blood cells is done before the          transplant. The cells are studied to evaluate the patient's immune system. Whole blood          is withdrawn through a catheter in an arm vein or through the central line and directed          into a machine that separates the blood components by spinning. The white cells are          removed and the red cells and plasma are returned to the body.        4. Immunosuppressive medication following transplantation             -  Adults receive thymoglobulin at the time of the transplant and for 3 days after               surgery; mycophenolate mofetil daily after the transplant; tacrolimus twice a day               once the kidney is working well; and sirolimus daily.             -  Children receive daclizumab the day of the transplant, day 4 after surgery, and at               weeks 2, 4, 6, 8, 11, 15, 19, and 23, and mycophenolate mofetil daily after the               transplant.        5. Follow-up visits: After discharge from the hospital, patients return to the Clinical          Center for follow-up at 6 months, at 1 year, and then yearly for 5 years. A physical          examination is done the first four visits, and blood and urine samples are collected at          every visit. Kidney biopsies (removal of a small amount of kidney tissue through a thin          needle) are done at 6 months, 1, 3, and 5 years after the transplant. The biopsied          tissue is examined to evaluate how well the kidney is responding to the          immunosuppression medicines, to determine whether more or less medication is needed, and          to evaluate how the patient is responding to the donor kidney.        6. Routine laboratory tests, coordinated by the patient's local physician, are done 2 to 3          times a week for the first 2 to 3 months after transplantation, then weekly for several          more months, and at least monthly for life.   "
171356|NCT00074529|"     An investigational drug (MK0677) will be studied to determine whether it helps the memory and     cognition of patients with Alzheimer's Disease.   "
171357|NCT00074542|"     The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission     in subjects with Crohn's Disease who are responding to steroid induction therapy.      Patient safety and quality of life will also be monitored throughout the study.   "
171358|NCT00074555|"     The purpose of this study is to better understand the causes of rheumatoid arthritis (RA),     particularly in African Americans.   "
171359|NCT00074568|"     Scleroderma is likely caused by a combination of factors, including an external trigger     (infection or other exposure) and a genetic predisposition. The Scleroderma Registry will     conduct genetic analyses for disease-related genes in patients with scleroderma and their     family members (parents, brothers, and sisters).   "
171360|NCT00074581|"     This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV     among couples in which one partner is HIV infected and the other is not.   "
171361|NCT00074607|"     Subject's are being asked to take part in this study because he or she has a type of cancer     that has spread to the meninges (tissues that cover the brain and spinal cord).      There is no known effective treatment for this specific disease or the subject has received     all of the treatments that are known to work for his or her specific disease without success.     Currently, there is no other effective treatment for this type of cancer.      The purposes of this study are:        -  to determine the highest dose of gemcitabine, an anti-cancer drug, that can safely be          given directly into the spinal fluid of children and adults whose cancer no longer          responds to standard treatment;        -  to find out what effects (good and bad) gemcitabine has when given directly into the          cerebrospinal fluid (called intrathecal administration) in children and adults with          neoplastic meningitis (cancer that has spread to the lining of the brain and spinal          cord);        -  to determine if gemcitabine is beneficial to the patient;        -  to understand how gemcitabine is handled by the body after intrathecal administration.   "
171362|NCT00074620|"     The study will look at the safety profile (unwanted effects) of the long-lasting     anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of     unfractionated heparin, commonly used in haemodialysis to avoid clotting of the graft and of     the haemodialysis machine.   "
171363|NCT00074633|"     Increasingly more individuals are trying to lose weight. Indeed, many women, regardless of     their size, experience a life-long battle and preoccupation with their weight. Despite the     attention to weight and the increase in diet behavior, the incidence of obesity continues to     rise. There is little data to show improved long term success for the majority of     participants who engage in weight loss behaviors.      The specific aim is to improve the psychological and metabolic health of obese women with a     history of chronic dieting through encouraging Health at Every Size (HAES). This treatment     model emphasizes intutitive eating, i.e., internal regulation of eating (responding to cues     of hunger, appetite and satiety). The HAES model is being compared to the current standard of     care in obesity treatment, energy restriction dieting, which encourages cognitive control of     eating and weight reduction.   "
171364|NCT00074646|"     Phase I trial of CC-8490 for the treatment of subjects with recurrent/refractory high-grade     gliomas   "
171375|NCT00080951|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and     oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than one drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy as first-line     therapy in treating patients who have metastatic colorectal cancer.   "
171376|NCT00080977|"     RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell     carcinoma (kidney cancer) cells.      PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works     in treating patients with metastatic renal cell carcinoma that has not responded to previous     low-dose intravenous or subcutaneous interleukin-2.   "
171377|NCT00080990|"     This phase I trial is studying the side effects and best dose of alvocidib when given     together with oxaliplatin, fluorouracil, and leucovorin calcium in treating patients with     advanced solid tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin,     fluorouracil, and leucovorin calcium, work in different ways to stop tumor cells from     dividing so they stop growing or die. Alvocidib may also make tumor cells more sensitive to     chemotherapy. Combining more than one chemotherapy drug may kill more tumor cells.   "
171706|NCT00086190|"     The purpose of this study is to find out if two antidepressant medications, paroxetine and     venlafaxine, can help control depression in Parkinson's disease, and if these medications     affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and     balance.   "
171365|NCT00074672|"     This study will explore what occurs between sensory and motor systems in restless legs     syndrome (RLS). Patients with RLS have uncomfortable sensations in the legs, usually in the     evening or early part of the night. Most patients also have periodic involuntary leg     movements. The condition tends to worsen over time, resulting in severe discomfort and sleep     disturbances.      Healthy normal volunteers and patients with RLS between 18 and 80 years of age may be     eligible for this study. All candidates will be screened with a medical history, physical and     neurological evaluations, electroymogram (measure of muscle activity), overnight sleep study,     electrocardiogram (ECG, measurement of the electrical activity of the heart), and blood and     urine tests. They may also have brain or spine magnetic resonance imaging (MRI) or     computerized tomography (CT) scans and a chest X-ray. Participants must stop taking all     medications prohibited by the study for 2 days or more before the study starts and throughout     its duration.      Participants will undergo prepulse inhibition tests to assess nervous system function. The     participant sits comfortably in a quiet room. Several cables are attached to the face and     legs using a special cream that conducts electrical signals through the cables to recording     equipment. Nervous system activity is evaluated while the subject is at rest and after     sensory stimulation (stimulating the nerves in the legs and face with a very brief electrical     current of mild to moderate intensity). At times, the subject receives a short, mild sound     stimulation delivered through earphones. The testing session takes 4 to 6 hours.   "
171366|NCT00074685|"     The ichthyoses are a family of genetic skin diseases characterized by dry, thickened, scaling     skin. Dermatologists estimate that there are over twenty varieties of ichthyosis, with a wide     range of severity and associated symptoms. This registry is designed to identify people in     the United States with the ichthyoses and other related disorders and to collect information     about their skin ailment and how it has affected them. The database is available for review     by approved research applicants. The registry is confidential and provides investigators a     way to share information about studies and trials with potential participants while     maintaining participants' privacy.      Although the Registry is closed to new enrollment, it is still maintained in order to provide     information related to understanding the diagnosis, pathophysiology, and treatment of     ichthyoses. Support for studies continues and inquiries from investigators are welcomed.   "
171367|NCT00074698|"     The purpose of this study is to evaluate the safety and tolerability of FG-3019, a     therapeutic antibody designed to block the pro-fibrotic activity of connective tissue growth     factor (CTGF). CTGF triggers the production of collagen and fibronectin, which cause scarring     and thickening of the lungs. Approximately 18 to 27 males and females, 21 to 80 years of age     with a diagnosis of idiopathic pulmonary fibrosis (IPF) will be enrolled in this study. The     duration of the study is approximately one month, during which patients will receive a single     infusion of FG-3019. In addition, there will be two follow-up visits 6 and 12 months after     receiving the study drug.   "
171368|NCT00074711|"     Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two     minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly     prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus     available for bone building. Teriparatide is a drug that reduces the risk of fractures by     increasing bone thickness and strength. Vitamin D is also necessary for strong bones and     teeth. The purpose of this study is to evaluate the bone-building effectiveness of two     calcium supplements, one with a source of phosphorus and one without, in combination with     teriparatide and vitamin D in women with osteoporosis.   "
171369|NCT00074724|"     To define the role of the assessment of myocardial viability with dobutamine echocardiography     (DE) in the clinical evaluation and selection of the best treatment for a high-risk subset of     patients with coronary artery disease.   "
171370|NCT00074737|"     The principal goal of this clinical trial is to assess the ability of cenersen sodium (EL625)     to improve cancer responsiveness to the established AML therapeutic agent Idarubicin used     alone or in combination with Cytarabine (Ara-C).      Cenersen sodium is a drug that is designed to block the effects of a protein called p53.     Laboratory evidence shows that blocking p53 will make many types of cancer, including acute     myelogenous leukemia (AML), more sensitive to a variety of established cancer therapeutics     while making normal tissues more resistant to the toxic effects of these agents.   "
171371|NCT00074750|"     DTGM belongs to a new generation of drugs designed to target leukemic cells. To achieve this,     DTGM takes advantage of the ability of naturally-produced growth factor (GM,     granulocyte-macrophage stimulating factor) to deliver a drug (diphtheria toxin) to cells;     preferably leukemic cells. It then attaches to the cells and allows the toxin to enter the     leukemic cells and destroy them.   "
171372|NCT00080912|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet     known whether single-fraction (single-dose) re-irradiation therapy is as effective as     multiple-fraction (many small doses of radiation therapy) re-irradiation therapy in relieving     bone pain caused by bone metastases.      PURPOSE: This randomized phase III trial is studying single-dose radiation therapy to see if     it works as well as multiple-dose radiation therapy in treating patients previously     irradiated with painful bone metastases.   "
171373|NCT00080925|"     RATIONALE: Donor peripheral stem cell transplantation may be able to replace bone marrow and     immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a     donor are rejected by the body's normal cells. Eliminating the T cells from the donor cells     before transplanting them and giving cyclosporine may prevent this from happening.      PURPOSE: This phase I trial is studying the side effects of T-cell-depleted allogeneic stem     cell transplantation after immunoablative induction chemotherapy and reduced-intensity     transplantation conditioning (chemotherapy) in treating patients with hematologic     malignancies.   "
171374|NCT00080938|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as     temozolomide may make the tumor cells more sensitive to radiation therapy. Combining     temozolomide with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving temozolomide together with     whole-brain radiation therapy works in treating patients with brain metastasis secondary to     non-small cell lung cancer.   "
171434|NCT00082290|"     RATIONALE: Massage therapy may help lessen pain caused by cancer.      PURPOSE: This randomized phase II trial is studying how well massage therapy works in     treating patients with cancer pain.   "
171378|NCT00081003|"     RATIONALE: Screening tests, such as nipple aspiration, ductal lavage, and breast duct     endoscopy, may help doctors detect cancer cells early and plan more effective treatment for     breast cancer.      PURPOSE: This clinical trial is studying how well nipple aspiration, ductal lavage, and     breast duct endoscopy work in detecting cancer cells in healthy women who are at     moderate-to-high risk of developing breast cancer.   "
171379|NCT00081029|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.     Intensity-modulated radiation therapy delivers thin beams of radiation of different strengths     directly to the tumor from many angles. This type of radiation therapy may reduce damage to     the parotid (salivary) glands, prevent xerostomia (dry mouth), and improve quality of life.     It is not yet known whether intensity-modulated radiation therapy is more effective than     conventional radiation therapy in preventing xerostomia and improving quality of life in     patients who have throat cancer.      PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to     see how well it works compared to conventional radiation therapy in treating patients with     oropharyngeal or hypopharyngeal cancer who are at risk of developing xerostomia caused by     radiation therapy.   "
171380|NCT00081042|"     RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor     cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well ABI-007 works in treating patients with     inoperable (unresectable) locally recurrent or metastatic melanoma.   "
171381|NCT00081055|"     RATIONALE: OTI-010 may be effective for graft-versus-host disease prophylaxis (prevention) in     patients who are undergoing donor peripheral stem cell transplantation for hematologic     malignancies (cancer of the blood or bone marrow).      PURPOSE: This randomized phase II trial is studying how well OTI-010 works in preventing     graft-versus-host disease in patients who are undergoing donor peripheral stem cell     transplantation for hematologic cancer.   "
171382|NCT00081068|"     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with     Waldenstrom's macroglobulinemia.   "
171383|NCT00081094|"     RATIONALE: Imaging procedures, such as carbon-11 acetate positron emission tomography (PET)     and fludeoxyglucose F 18 PET, may improve the ability to detect hepatocellular carcinoma     (liver cancer) and allow doctors to plan the most effective treatment.      PURPOSE: This clinical trial is studying how well carbon-11 acetate PET and fludeoxyglucose F     18 PET work in detecting cancer in patients with liver cancer.   "
171384|NCT00081107|"     RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well epothilone D works in treating patients     with stage IIIB or stage IV non-small cell lung cancer that has not responded to     platinum-based chemotherapy.   "
171385|NCT00081133|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to     stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the     growth of cancer cells by blocking the enzymes necessary for their growth. Combining arsenic     trioxide with imatinib mesylate may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide     when given with imatinib mesylate and to see how well they work in treating patients with     accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia     chromosome-positive acute lymphoblastic leukemia.   "
171386|NCT00081159|"     RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as     goserelin and leuprolide may fight prostate cancer by stopping the adrenal glands from     producing androgens. Drugs used in chemotherapy such as doxorubicin work in different ways to     stop tumor cells from dividing so they stop growing or die. Zoledronate may prevent bone loss     and stop the growth of tumor cells in bone. Radioactive substances such as strontium-89 may     relieve bone pain associated with prostate cancer. It is not yet known whether hormone     (androgen) ablation therapy and chemotherapy combined with zoledronate is more effective with     or without strontium-89 in treating prostate cancer and bone metastases.      PURPOSE: This randomized phase II trial is studying giving hormone ablation therapy,     doxorubicin, and zoledronate together with strontium-89 to see how well it works compared to     hormone ablation therapy, doxorubicin, and zoledronate alone in treating patients with     androgen-dependent prostate cancer and bone metastases.   "
171387|NCT00081172|"     RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or     deliver radioactive tumor-killing substances to them without harming normal cells.      PURPOSE: This phase II trial is studying how well radiolabeled monoclonal antibody works in     treating patients with progressive metastatic androgen-independent adenocarcinoma (cancer) of     the prostate.   "
171388|NCT00081211|"     Phase I trial to study the effectiveness of intratumoral (in the tumor) PV701 in treating     patients who have advanced or recurrent unresectable squamous cell carcinoma (cancer) of the     head and neck. Vaccines made from a specially-modified virus such as PV701 may make the body     build an immune response to kill tumor cells while leaving normal cells undamaged. Injecting     PV701 directly into the tumor may cause a stronger immune response and kill more tumor cells   "
171435|NCT00082303|"     The purpose of this study is to explore the effect of music imagery on patients receiving     intensive chemotherapy for acute leukemia or high-grade non-Hodgkin’s lymphoma.   "
171389|NCT00081224|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Celecoxib may also make tumor cells more sensitive     to chemotherapy and radiation therapy. Giving celecoxib with capecitabine and radiation     therapy before surgery may shrink the tumor so that it can be removed.      PURPOSE: This phase II trial is studying how well giving neoadjuvant celecoxib together with     capecitabine and pelvic irradiation works in treating patients with stage II or stage III     adenocarcinoma (cancer) of the rectum.   "
171707|NCT00086203|"     The objective of this study is to assess the efficacy and safety of talabostat and rituximab     in patients with advanced CLL who failed to respond, or have progressed following a prior     response, to a fludarabine regimen.   "
171390|NCT00081237|"     RATIONALE: OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop     tumor cells from dividing so they stop growing or die. Combining OSI-7904L with oxaliplatin     may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of OSI-7904L and     oxaliplatin in treating patients with refractory or recurrent advanced colorectal cancer.   "
171391|NCT00081250|"     RATIONALE: It is not yet known whether the supplement creatine is effective in increasing     weight and improving appetite and quality of life in patients who have cancer.      PURPOSE: This randomized phase III trial is studying how well creatine works in increasing     weight and improving appetite and quality of life in patients with weight loss caused by     cancer.   "
171392|NCT00081263|"     This randomized phase II trial is studying how well celecoxib works in preventing cervical     cancer in patients with CIN. Chemoprevention therapy is the use of certain drugs to try to     prevent the development of cancer or to treat early cancer. Celecoxib may be effective in     preventing the development of cervical cancer in patients who have cervical intraepithelial     neoplasia (CIN).   "
171393|NCT00081276|"     Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor     cells from dividing so they stop growing or die. Combining more than one drug may kill more     tumor cells. This phase II trial is studying how well giving 3-AP together with cisplatin     works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial     cancer or primary peritoneal cancer   "
171394|NCT00081289|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery     may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill     any remaining tumor cells.      PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant     chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating     patients who are undergoing surgical resection for locally advanced rectal cancer.   "
171395|NCT00081302|"     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells     from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to     damage tumor cells. Giving cetuximab together with combination chemotherapy and radiation     therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with paclitaxel,     carboplatin, and radiation therapy works in treating patients with unresectable stage IIIA or     stage IIIB non-small cell lung cancer.   "
171396|NCT00081315|"     The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine     on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with     unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined     modality therapy.   "
171397|NCT00081328|"     The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National     Institutes of Health (NIH) has sponsored a consortium of investigators to conduct a clinical     treatment trial, Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY).      The primary objective of the TODAY trial is to compare the efficacy of three treatment arms     on time to treatment failure based on glycemic control. The secondary aims are to:        -  compare and evaluate the safety of the three treatment arms;        -  compare the effects of the three treatments on the pathophysiology of type 2 diabetes          (T2D) with regards to beta cell function and insulin resistance, body composition,          nutrition, physical activity and aerobic fitness, cardiovascular risk factors,          microvascular complications, quality of life, and psychological outcomes;        -  evaluate the influence of individual and family behaviors on treatment response; and        -  compare the relative cost effectiveness of the three treatment arms.      The three treatment regimens are: (1) metformin alone, (2) metformin plus rosiglitazone, and     (3) metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program     (TLP). The study recruits patients over a three-year period and follows patients for a     minimum of two years. Patients are randomized within two years of the diagnosis of T2D.   "
171398|NCT00081783|"     This is a Phase II single arm study of a novel T cell immunotherapy in patients with indolent     non-Hodgkin’s lymphoma (NHL). Eligible patients will have relapsed or refractory disease     after receiving at least one and no more than four prior regimens. Patients will receive     Xcellerated T CellsTM, an ex vivo activated and expanded autologous T cell product, in an     attempt to enhance immune responses with anti-tumor activity. The primary endpoint of the     study is to evaluate the efficacy of Xcellerated T Cells in patients with indolent NHL.     Secondary endpoints are to evaluate the safety of the therapy in this patient population, and     to evaluate changes in the number and phenotype of T- and B-lymphocytes, as well as changes     in the T cell receptor repertoire, hemoglobin levels, platelet counts and quantitative     immunoglobulin levels. In a subset of patients, fine-needle aspirates of malignant lymph     nodes will be performed to assess changes in the lymphocyte composition and phenotype. Bone     marrow aspirates will be similarly evaluated. Finally, anti-tumor immune responses will be     evaluated in patients amenable to biopsy of enlarged lymph nodes.   "
171399|NCT00081796|"     The purpose of this clinical trial is to determine if RPR109881 is a better treatment than     capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from     docetaxel and/or paclitaxel.   "
179521|NCT00185081|"     The purpose of this study is to test the safety of the peptide and antibody and at the same     time evaluate the tumor imaging of a two step antibody technique in nuclear imaging.   "
171436|NCT00082316|"     This study is a randomized, open-label multi-center evaluation of the tolerability of     treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4%     lidocaine-based local anesthetic products. Eligible subjects will have moderate to severe     neuropathic pain secondary to painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN)     or HIV-associated neuropathy (HIV-AN), with average numeric pain rating scale (NPRS) scores     during screening of 3 to 8 (inclusive).   "
171708|NCT00086216|"     This is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and     to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma.   "
171400|NCT00081809|"     Primary Objectives:        -  To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of          selected patients with indolent lymphoma. The efficacy endpoints are:        -  the rate of complete and partial responses        -  the time to progression.      Secondary Objectives:        -  To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein          peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive          weeks, followed by HSPPC-96 administered once every two weeks.        -  To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens.        -  To assess approximately the composition of the tissue source of the autologous HSPPC-96          for each patient.        -  To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the          expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of          patients with indolent lymphoma.   "
171401|NCT00081822|"     The purpose of this study is to determine the recommended phase II dose of clofarabine when     administered in combination with standard dose Ara-C to older (>=60 years of age) patients     with newly diagnosed acute myeloid leukemia (AML).   "
171402|NCT00081835|"     This study will evaluate patients with eye complications related to vaccination against     smallpox to learn more about these conditions. Vaccinia vaccination has been used for more     than 100 years for preventing smallpox. A small number of people who receive the vaccination     (less than 1 in 1,000) develop complications, sometimes in their eyes. This usually results     from the accidental transfer of the infection from the vaccination site to the face or eyes,     perhaps by touching the vaccination area and then the face or eyelids before washing the     hands. The study will also examine whether an experimental treatment called NP-016 vaccinia     immune globulin can reduce corneal scarring that is sometimes associated with serious     vaccinia complications and can impair vision.      Children and adults with keratitis, severe conjunctivitis, or blepharitis following exposure     to vaccinia vaccination may be eligible for this study. Children must weigh at least 10 kg.      Participants undergo the following tests and procedures at enrollment, with some tests     repeated at scheduled study visits:        1. Medical history and physical examination        2. Infectious disease consultation        3. Complete eye evaluation including:             -  Fundus photography to examine the back of the eye - dilation of the pupils with eye               drops to examine and photograph the back of the eye             -  Slit lamp biomicroscopy - evaluation of the front part of the eye with a slit lamp               microscope             -  Eye pressure measurements             -  Eye swab to look for vaccinia virus or other causes of disease        4. Blood tests        5. Photographs and documentation of eye and skin lesions        6. Vaccinia diagnostic tests, such as skin or mucosa scrapings; blood, throat, or urine          cultures; and tissue biopsies, if needed      Patients begin treatment with standard medications for their eye disease, such as     trifluridine (Viroptic® (Registered Trademark)) anti-viral eye drops. Patients whose     condition becomes serious are offered additional treatment with intravenous (through a vein)     infusions of either VIG or placebo (salt water solution with no active drug) and are randomly     assigned to one or the other treatment group. All patients continue standard-of-care     treatment as well.      Follow-up visits at the NIH eye clinic are scheduled as required by the patient's condition.     Patients with mild complications who are taking only standard medications may need to be seen     only 1 month after the initial visit and then 6 months and 12 months later. Patients with     more serious conditions who qualify for VIG or placebo treatments may be seen daily for a     week, then once a week for the rest of the first month, and then at 6 months and 12 months,     unless more frequent treatment or observation is required.   "
171403|NCT00081848|"     This study will evaluate the safety and effects of vaccine treatment plus radiation to the     liver in patients with solid tumors that have spread to the liver. The vaccine treatment     consists of three parts: 1) a priming vaccine called rV-CEA(6D)-TRICOM, made from vaccinia     virus; 2) a boosting vaccine called rF-CEA(6D)-TRICOM), made from fowlpox virus; and 3) a     fowlpox virus injected with DNA for GM-CSF, a chemical that boosts the immune system, called     rF-GM-CSF. Human DNA is inserted into the priming and boosting vaccine viruses to cause     production of proteins that enhance immune activity and also to produce carcinoembryonic     antigen (CEA) - a protein that is normally produced by the patient's tumor cells. The study     also uses radiation, because laboratory and animal studies show that low doses of radiation     to tumors that produce CEA make the tumor more sensitive to the effects of the vaccines.      Patients 18 years of age and older who have a solid tumor that has spread to the liver may be     eligible for this study. Candidates must have had at least one course of chemotherapy for     metastatic disease and their tumor must produce CEA. Candidates are screened with a medical     history and physical examination; blood and urine tests, test of pathology slides from     surgery to determine the presence of the CEA marker, imaging studies to assess the extent of     tumor, and an electrocardiogram (and cardiologic evaluation, if clinically indicated).      Participants receive the priming vaccination on study day 1. After 3 weeks and then again     every 2 weeks for 2 months (study days 21, 35, 49 and 63), they receive a boosting vaccine.     All vaccines are injected under the skin. With every vaccination they also receive an     injection of rF-GM-CSF to increase the number of immune cells at the vaccination site. The     day after each of the first four boosting vaccinations, patients undergo 4 consecutive days     of radiation to the tumor in the liver (study days 22-25, 36-39, 50-53 and 64-67). Patients     may continue treatment with monthly booster vaccinations (without further radiation therapy)     as long as their cancer does not get worse and they do not develop serious treatment side     effects.      Patients are monitored for safety and treatment response with the following tests and     procedures:        -  Blood and urine tests and clinic visits every 2 to 4 weeks to monitor liver, kidney, and          other organ function.        -  Imaging studies to assess the tumor around study day 91 and every 2 months after that          while on the study.        -  Apheresis (a procedure for collecting immune cells called lymphocytes) - Apheresis is          done before the first vaccination on study day 1 and again around study day 91. For this          procedure, blood is collected through a needle in an arm vein. The blood circulates          through a machine that separates it into its components by spinning, and the lymphocytes          are extracted. The rest of the blood is returned to the patient through the same needle.          The collected lymphocytes are studied to measure the immune response to treatment.        -  Liver biopsy (optional) - This test is done once before starting radiation treatment and          again around 3 to 7 days after completing the first dose of radiation. The biopsy          provides information on the type of cancer, the level of CEA produced by the tumor, and          the immune status of the tumor. For this procedure, the skin over the liver is numbed          with an anesthetic, a needle is placed in the liver tumor, and a small sample of tumor          is withdrawn through the needle.      After treatment is completed, patients are monitored for up to 15 years, including yearly     medical histories and physical examinations for 5 years following their last vaccination.     Information beyond 5 years is collected once a year by telephone   "
171404|NCT00081861|"     Phase II Study of Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or     Rituxan Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma.   "
171405|NCT00081874|"     The goal of this clinical research study is to find the highest safe dose of RAD001 that can     be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is     to learn how effective the dose that is found is as a treatment.   "
171406|NCT00081887|"     Primary Objectives:        1. To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic          Leukemia (CLL).        2. To determine the toxicity profile of clofarabine in CLL.        3. To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology          profile of clofarabine in CLL.   "
171407|NCT00081900|"     Approximately 18-45 patients with Hepatocellular Carcinoma (HCC) will be treated with DENSPM     at approximately 5 centers in the United States. First, we will be trying to determine the     highest dose that can be given safely and is well tolerated (this is called the maximally     tolerated dose, or the MTD, for short). Once that is established, we will enroll additional     patients to learn more about potential side effects and to see whether DENSPM can slow the     growth of HCC tumors. We also want to learn about the safety of DENSPM. Many medications used     to treat cancer cause side effects (discomforts or illness). In this study, we want to     understand what side effects occur in patients with HCC who are treated with DENSPM.Study was     terminated after initial assessment of insufficient data to support clinical benefit in this     population.   "
171408|NCT00081913|"     The purpose of this study is to determine if cell therapy with your own cells (autologous     cells) delivered with a catheter to regions of the heart with poor blood flow will be safe     and if it will relieve your chest pain and/or your ability to exercise.   "
171409|NCT00081926|"     This study will evaluate the molecular response to high dose Gleevec in newly diagnosed     patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase. This study will evaluate     the ability of Gleevec to reduce the amount of abnormal protein that occurs in patients with     CML.      Patients who are eligible to participate will be treated for 18 months. This trial will     include male or female patients 18 years or older who are newly diagnosed (within 6 months)     with CML.   "
171410|NCT00081939|"     There have been two previous Total Therapy studies for multiple myeloma (MM) at the Myeloma     Institute for Research and Therapy (MIRT): Total Therapy I (from 1989 through 1994) and Total     Therapy II (from 1996 to 2004). Results have shown that patients treated on these studies had     better outcomes (meaning patients have lived longer and had better responses to treatment)     when compared to patients treated with standard chemotherapy.      With this new study, Total Therapy III, researchers will take what they have learned from the     first two studies and add new treatment strategies to try to improve the outcomes even more,     especially for patients with chromosome abnormalities.   "
171411|NCT00081952|"     The purpose of this study is to determine the safety, tolerability, and effectiveness of the     amino acid L-isoleucine in the treatment of hot flashes in postmenopausal women.   "
171412|NCT00081965|"     RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not     yet known whether acupuncture is more effective than a placebo in treating hot flashes in     women with breast cancer      PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works     compared to a placebo in treating hot flashes in women with breast cancer.   "
171413|NCT00081978|"     The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse     Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when administered     twice daily for 48 weeks.   "
171414|NCT00081991|"     This study will use dynamic light scattering (DLS) technology to study normal lens aging and     early cataract formation. Cataract is a clouding of the lens that interferes with the passage     of light to the retina, impairing visual acuity. DLS uses a low intensity laser light     (similar to that used in supermarket checkouts) to measure lens cloudiness. It detects     changes in the human lens at the earliest molecular stages of cataract development, when     anti-cataract treatment would be most effective in reversing, delaying or preventing cataract     formation.      Healthy normal volunteers and patients with age-related cataract between 18 and 80 years of     age may be eligible for this study. Participants undergo the following tests and procedures:      Medical history      Eye examination, including the following:        -  Measurement of visual acuity (vision chart)        -  Measurement of eye pressure        -  Dilation of the pupils for slit lamp (microscope) examination and grading of lens          opacity        -  Ultrasound examination of the eye to determine distances between cornea, lens (including          lens thickness), and retina        -  Examination of the retina at the back of the eye        -  Dynamic light scattering of the lens (see below)        -  Lens photography using a camera with a bright flash      For the DLS procedure, the patient sits in front of the DLS device with his or her chin     placed on a chin rest and fixes on a yellow target in the center of the camera lens. When the     eye is properly aligned, DLS measurements are taken on the lens.   "
171415|NCT00082017|"     This study will examine the effects of an experimental drug called UCN-01     (7-hydroxystaurosporine) on T-cell lymphomas. UCN-01 inhibits the growth of several different     tumor cells, and, in laboratory studies, it has worked particularly well on tumor cells taken     from patients with T cell lymphomas.      Patients 9 years of age and older with T cell lymphoma that has relapsed or is not responding     to chemotherapy may be eligible for this study. Candidates will be screened with a medical     histories and physical examinations, blood and urine tests, electrocardiograms, chest x-rays,     and computed tomography (CT) scans of the chest, abdomen and pelvis. Additional tests may be     done if clinically indicated, such as positron emission tomography (PET) scans, bone marrow     aspirations and biopsies, lumbar punctures (spinal taps) and CT's or magnetic resonance     imaging (MRI) scans if there is evidence of central nervous system disease.      Participants are given UCN-01 in 28-day treatment cycles. The drug is given by vein in a     continuous 72-hour infusion on the first cycle and in 36-hour infusions on subsequent cycles.     The total number of cycles patients receive depends on how well the tumor responds to the     drug and how well the patient tolerates drug side effects. Patients who do well may receive     treatment for up to 1 year. Patients whose disease worsens with treatment or who do not     tolerate the therapy are taken off the study.      Some or all of the screening tests are repeated periodically during the course of treatment     to monitor safety and treatment response. X-rays and scans are done every other treatment     cycle for the first 6 cycles and then, if the cancer is stable or improving, the interval     between these imaging studies is lengthened to every 4 cycles. Patients whose tumors can be     safely biopsied undergo this procedure before entering the study and 3 to 5 days after     completing the first UCN-01 treatment. Biopsies requiring open surgery (e.g., in the chest or     abdomen) are done only if absolutely necessary for medical care. Biopsy tissue, blood, and     other fluids are analyzed for gene and protein studies related to lymphoma research.   "
171416|NCT00082030|"     This study will explore brain function related to depressive symptoms and will examine DNA     for genes that may be involved in depressive disorders, particularly genes that regulate     synthesis and metabolism of the brain neurotransmitter catecholamine. It will compare     findings in patients with major depressive disorders who are in remission with those in     normal, healthy volunteers.      Patients with remitted major depressive disorders and healthy normal volunteers between 18     and 60 years of age may be eligible for this study. Candidates are screened with a     psychiatric and medical history, physical examination, electrocardiogram, and blood and urine     tests. Participants undergo the following tests and procedures in up to eight visits to the     NIH Clinical Center:      Memory Tasks and Problem Solving and Brain Imaging      Subjects are tested with measurements of intelligence or memory ability. They also undergo     magnetic resonance imaging (MRI), a test that uses a magnetic field and radio waves to     produce images of the brain. For this procedure, the patient lies on a table that is moved     into the scanner (a narrow cylinder), and wears earplugs to muffle loud knocking and thumping     sounds that occur during the scanning process. The MRI lasts about 60 minutes.      Catecholamine Depletion Study      For this study, subjects take capsules containing either AMPT (a drug that temporarily     reduces brain catecholamine activity) or a placebo (lactose capsules, which do not affect     brain catecholamine activity) at 9 a.m., 2 p.m., and 7 p.m. on one visit and return the next     day to take additional capsules at 7 a.m. and noon. In addition to the study medication,     subjects keep a low-monoamine diet (e.g., no chocolate, cheese, smoked meats, and various     other foods that will be enumerated) and do not smoke, drink alcohol, or take in food or     drink containing caffeine. After taking all the study capsules, the subjects have positron     emission tomography (PET) and functional MRI (fMRI) scans, as follows:        -  fMRI: While lying in the MRI scanner, the subject performs a monetary reward task that          is somewhat like playing a computer video game for money. The amount of cash the subject          can win depends on his or her performance. It is possible to lose money that was          previously won, if performance declines. This portion of the study provides information          on how the brain processes reward and about the role of catecholamines in this process.        -  PET: The subject is injected in the arm with a glucose solution that has a radioactive          substance attached that can be detected by the PET scanner. During the scan, the subject          looks at photographs of faces on a computer screen and is asked to tell the gender of          the persons. This test shows brain blood flow and measures brain glucose (sugar)          metabolism, which reflects brain activity. At the end of the scan, subjects are asked          about their mood and general well being. They return to the Clinical Center the          following day for and evaluation of their emotional state.      The catecholamine depletion study is repeated a second time 14 days or more after the first.     Subjects who received AMPT capsules for the first study take lactose capsules for the second     study, and vice-versa.   "
171417|NCT00082043|"     This study will explore the effects of dutasteride on mood and the stress response across the     menstrual cycle. Dutasteride blocks production of neurosteroids-hormones that help regulate     the stress response systems. These systems may be disturbed in women with menstrually related     mood disorders (MRMD). The effects of the drug will be compared in women with and without     MRMD to determine how neurosteroids regulate mood and the stress response across the     menstrual cycle. Dutasteride is approved by the Food and Drug Administration to treat benign     prostatic hyperplasia (excess growth of the prostate gland) in men.      Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this     study. Candidates are screened with a medical and psychiatric history, physical examination,     screening for symptoms of depression, and routine blood and urine tests. Participants are     required to use barrier contraception (condoms or diaphragm) during the 3-month study and     6-month follow-up.      Participants undergo the following tests and procedures:        -  Dutasteride or placebo treatment: Participants receive 1 month of dutasteride and 2          months of placebo. Neither the participants nor the investigators know when the subject          is taking the active medication or the placebo.        -  Biweekly follow-up visits: Every 2 weeks during the 3-month treatment period, patients          come to the NIH Clinical Center to have blood drawn and to complete mood symptoms          ratings.        -  Monthly follow-up visits: Participants return to the Clinical Center once a month for 6          months after the end of the treatment period to monitor hormone levels and pregnancy          status.   "
171418|NCT00082069|"     The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses     spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their     order of enrollment with consideration of their availability to complete the necessary     vaccinations and follow-up visits.   "
171419|NCT00082082|"     The objective of this Phase II trial is to compare the efficacy and safety of 6 months of     treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in     adult patients with non-surgical hepatocellular carcinoma (HCC).   "
171420|NCT00082095|"     The main purpose of this study is to compare treatment with either pegylated liposomal     doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women     60 years and older.   "
171421|NCT00082108|"     Myotonic dystrophy (DM) and facioscapulohumeral muscular dystrophy (FSHD) are inherited     disorders characterized by progressive muscle weakness and loss of muscle tissue. The purpose     of this registry is to connect people with DM or FSHD with researchers studying these     diseases. The registry will offer individuals with DM and FSHD an opportunity to participate     in research that focuses of their diseases. The registry will also help scientists to     accomplish research on DM and FSHD and to distribute their findings to patients and care     providers.   "
171422|NCT00082121|"     The purpose of this study is to determine if the study drug (TP10), which blocks complement     release, can reduce such side effects of complement inflammation as chest pain or heart     attacks and be taken safely in women who undergo cardiopulmonary bypass surgery.   "
171423|NCT00082134|"     This is a Phase II, non-randomized, open label study of ILX651 in patients with     hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40     patients will be enrolled in this study that is expected to last 24 months. All patients will     be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The     primary objective of this study is to determine the PSA response rate. The secondary     objectives are to determine response of measurable disease, duration of response, time to PSA     progression, time to treatment failure, survival, safety and tolerability, and     pharmacokinetic profile of ILX651.   "
171424|NCT00082147|"     This study will examine the usefulness of an imaging procedure called dynamic     contrast-enhanced magnetic resonance imaging (DCE-MRI) for localizing and characterizing     prostate cancer. For this test, a medicine is injected into a vein and the MRI measures how     the medicine flows through the prostate gland. The measurements provide information about the     blood vessels in the prostate gland, which provides other information about the cancer.     Several needle biopsies are performed during the procedure, and the results of the biopsies     are compared with the information from the DCE-MRI.      Men 18 years of age and older with suspected or confirmed prostate cancer may be eligible for     this study. Candidates are screened with a medical history and physical examination, blood     test, and review of tumor pathology.      Participants undergo DCE-MRI and needle biopsies of the prostate. The day before and the     morning of the procedure, patients are given an antibiotic called Levofloxacin. They also     have a small enema the morning of the test. A local anesthetic is then given in the area     around the prostate to numb the tissue and decrease any discomfort from the procedure. A tube     is placed in the rectum to obtain better pictures of the prostate gland during the imaging.     During the scan, the patient may be asked to breathe air that contains higher concentrations     of oxygen and carbon dioxide than are in room air. The MRI scans guide the physician in     selecting areas of the prostate to biopsy. For each biopsy, a needle is placed through the     rectum into the prostate gland. When the needle is in place, a small tissue sample is     withdrawn. This procedure is repeated until 4 to 10 biopsies are taken. During the procedure,     which lasts about 1 hour, the patient lies on his stomach on a stretcher.      Patients who are planning to undergo surgery or radiation treatment for their cancer at the     NCI may have up to four 1-mm non-reactive gold markers placed in the prostate during the     DCE-MRI procedure. The markers are left in place to help target the radiation treatments and     to show where the biopsies were taken if the prostate is removed.      At the end of the procedure, the patient is moved to a bed to recover and may get up and     urinate after about 30 to 60 minutes. After a period of observation, the patient is     discharged home with a dose of antibiotic to take the next day.      Some patients may be asked to repeat the MRI and biopsy procedure during or after their     treatment for prostate cancer to help investigators learn whether the MRI test is still     helpful after treatment. Repeat testing is optional.   "
171425|NCT00082160|"     The purpose of this study is to use brain imaging technology to identify the parts of the     brain that are activated during meditation and to compare these parts to those activated     during other activities. This study will also determine the effects of meditation on     involuntary functions, such as breathing.   "
171426|NCT00082173|"     Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and     then two drugs for 4 months. New drug regimens that are shorter and effective against     drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin     (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively     treat TB.   "
171427|NCT00082186|"     The objective of the study is to evaluate the effects of chronic TRACLEER® treatment on     testicular function via semen analysis in male patients with primary pulmonary arterial     hypertension (PAH).   "
171428|NCT00082199|"     The purpose of this clinical research study is to learn whether subjects treated with     aripiprazole are able to abstain from alcohol use for a greater number of days than subjects     treated with placebo. The safety of using aripiprazole will also be studied.   "
171429|NCT00082212|"     The purpose of this study is to determine the overall response rate, time to progression, and     1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma.   "
171430|NCT00082225|"     Patients have a type of cancer called Hodgkin's lymphoma or non-Hodgkin's lymphoma, which has     come back or not gone away or is at high risk for coming back after treatment, including the     best treatment investigators know for this disease. Investigators are asking the patient to     volunteer to be in a research study using a new experimental therapy consisting of special     immune system cells called LMP2 specific cytotoxic T lymphocytes in combination with a     special protein called a monoclonal antibody.      Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of infection with the virus     that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their     diagnosis of the lymphoma. EBV is found in the cancer cells of up to half the patients with     lymphoma, suggesting that it may play a role in causing lymphoma. The cancer cells infected     by EBV are able to hide from the body's immune system and escape destruction. Investigators     want to see if special white blood cells, called T cells, that have been trained to kill EBV     infected cells can survive in the blood and affect the tumor.      The investigators have used this sort of therapy to treat a different type of cancer that     occurs after bone marrow and solid organ transplant called post transplant lymphoma. In this     type of cancer the tumor cells have 9 proteins made by EBV on their surface. They grew T     cells in the laboratory that recognized all 9 proteins and were able to prevent and treat     post transplant lymphoma. However in Hodgkin disease and non-Hodgkin Lymphoma the tumor cells     only express 2 EBV proteins. In a previous study investigators made T cells that recognized     all 9 proteins and gave them to patients with Hodgkin disease. Some patients had a partial     response to this therapy but no patients had a complete response. Investigators think one     reason may be that many of the T cells reacted with proteins that were not on the tumor     cells. They are now trying to find out if they can improve this treatment by growing T cells     that only recognize one of the proteins expressed on Lymphoma cells called LMP-2. These     special T cells are called LMP-2 specific cytotoxic T-lymphocytes (CTLs).      In this study investigators also are trying to see if they can improve these results by     treating patients first with a special protein called an antibody and then giving the EBV     specific T cells. The reason for doing this is that EBV specific T cells have worked very     well in bone marrow transplant patients to prevent and treat EBV cancers. These patients have     very few of their own immune cells when they are given the trained T cells and therefore     there is a lot of space for the trained cells to grow. Investigators hope that they can     improve the effect of the trained T cells in Hodgkin disease and non-Hodgkin Lymphoma     patients by first temporarily removing the patient's own T cells before giving the trained     cells.   "
171431|NCT00082238|"     People with CF have a high incidence of diabetes, called CFRD. CFRD is an important cause of     worsened morbidity and mortality, thus understanding the pathophysiology underlying its     development is imperative. Insulin deficiency has been well recognized as one cause of CFRD;     however the clinical presentation and studies of pathogenesis indicate that the etiology is     more complex. There is strong evidence that normal metabolism of carbohydrate, protein and     fat is altered in CF. We believe that the inflammatory response to chronic underlying lung     disease is responsible for insulin resistance and alters substrate metabolism, and that these     changes, in addition to insulin deficiency cause CFRD. Our global hypothesis is that     hyperglycemia is caused, in part, by high rates of gluconeogenesis resulting from excessive     amino acid substrate availability caused by cytokine-mediated protein catabolism. We further     hypothesize that inflammation alters normal fatty acid metabolism leading to lipogenesis, an     energy wasteful pathway. We will recruit 24 adult CF subjects and 10 controls (similar in     distribution in lean tissue mass, age and gender) and will categorize them according to     glucose tolerance (OGTT), as well as insulin secretion and insulin sensitivity using the     Tolbutamide-stimulated IVGTT and the Minimal Model. Clinical status will be characterized by     measuring pulmonary function and modified NIH scores, in addition to measuring levels of     circulating cytokines. Gluconeogenesis (GNG) will be quantified by measuring the     incorporation 2H into the 2nd, 5th and 6th carbons of glucose. Amino acid turnover rates will     be measured using stable isotopes of lactate and alanine and whole body protein turnover     (WBPT) will be measured using [1-13C]leucine and [15N2]urea. Fat metabolism will be evaluated     by measuring ketone body turnover using stable isotopes, and by quantifying lipogenesis using     the isotopomer equilibration method. Key enzymes of fatty acid metabolism will also be     measured. We will utilize indirect calorimetry to measure resting energy expenditure.     Subjects will be recruited from the CF centers at the University of Texas- Southwestern and     the South Central CF Consortium.      Our proposal is intended to better describe the unique metabolism of people with CF, and to     provide a comprehensive evaluation of pathophysiologic changes which contribute to the     development of CFRD and to wasting; and are part of the applicant's long-range goal which is     to identify the underlying causes of CF related diabetes and catabolism so that     disease-specific therapies can be developed. We fully expect that the proposed studies will     provide new and important information.   "
171432|NCT00082251|"     The purpose of this study is to compare the effectiveness and safety of different doses of     Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood     (dyslipidemia).   "
171433|NCT00082277|"     The purpose of this study is to evaluate safety parameters of anastrozole with regard to its     potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted     to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal     women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer     and who are high or moderate risk of fragility fracture. It is also conducted to determine     the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at     low risk of fragility fracture.   "
179522|NCT00185094|"     To examine the effect of three different blood pressure medications on the insulin     sensitivity in overweight patients with high blood pressure.   "
171437|NCT00082329|"     This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating     factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than     the use of G-CSF alone. Traditionally, the growth factor G-CSF has been given to stem cell     donors to mobilize, or push, stem cells out of the bone marrow and into the blood circulation     for collection for transplantation. Although a sufficient quantity of cells usually can be     collected with G-CSF treatment, some donors do not respond well and may require multiple     apheresis procedures (see below) to collect enough cells. Studies indicate that G-CSF used     together with a drug called AMD3100 may be more effective in mobilizing stem cells for     collection than G-CSF alone. The Food and Drug Administration has approved G-CSF for stem     cell mobilization. AMD3100 is a new drug that also mobilizes stem cells in large numbers     within a few hours.      Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.   "
171438|NCT00082342|"     This study will examine the effects of transcranial direct current stimulation (tDCS) on gait     (walking) problems and rigidity in patients with Parkinson's disease. tDCS is a method of     brain stimulation that may be able to change the electrical activity of the nerves of the     brain, possibly causing Parkinson's disease symptoms to improve.      Patients between 40 and 80 years of age with moderately severe Parkinson's disease whose main     symptoms are problems with walking, including freezing, or rigidity, may be eligible for this     study. Candidates must be taking Sinemet or another L-DOPA drug and not have too much tremor.      Participants will be assigned to receive either real or sham (placebo) tDCS. Both groups will     have eight treatments over 3-1/2 weeks. For the tDCS, electrodes are placed on wet pads on     the scalp. An electrical current passes through the electrodes, travels through the scalp and     skull, and causes small electrical currents in the cortex-the outer part of the brain.     Participants will have a neurological examination, including an evaluation of walking, just     before and just after each tDCS session. Patients' motor function will be re-evaluated at 1,     3, and 6 months after the last tDCS treatment.   "
171439|NCT00082355|"     This study will test the effectiveness of low-dose recombinant tissue plasminogen activator     (rtPA, or alteplase) in dissolving blood clots in deep leg veins. Alteplase is used to clear     blood clots in coronary arteries in patients having heart attacks. Blood clots can develop in     the deep leg veins causing pain and swelling and may break loose and lodge in the lungs.     Current routine treatments use anticoagulants such as heparin stop the clots from enlarging     and prevent clots from moving to the lung but do not reliably dissolve clots in the leg.In an     earlier study we showed that rtPA could be used to actually dissolve the clots. This study     will determine whether lower doses of rtPA can dissolve clots with fewer bleeding     complications than the current higher-dose regimens.      Patients 18 years of age and older who have blood clots in a deep vein of the pelvis or leg     may be eligible for this study if they have had symptoms for 14 days or less and if they have     never had clots in their deep veins before.      Participants are admitted to hospital for up to 5 days. On the first treatment day, the     patient has a venogram to show the location of the clots. The radiologist injects an x-ray     contrast material into a small vein in the foot and watches the dye by x-ray as it moves up     the leg, revealing the clot(s). A catheter (plastic tube) is then inserted into a vein either     behind the knee, in the groin, or in the neck, and advanced until it reaches the clots. When     the catheter is in place, rtPA is injected while the radiologist watches the vein under the     x-ray image. The amount of rtPa needed will depends on the size of the clot. Up to five     venograms may be done if the clot requires the maximum four rtPA treatments allowed in this     study. During the treatments, patients receive standard doses of heparin, given continuously     by vein, After completion of treatments, anticoagulation is continued through use of a low     molecular weight heparin (usually enoxaparin) given by subcutaneous injection as a transition     medication during conversion to anticoagulation with warfarin ( also known as coumadin),     another blood thinner, taken by mouth. Patients continue taking warfarin for 6 months.      During thrombolytic therapy, blood samples are drawn shortly before the first dose of rtPA     and at five time points afterward to measure the rtPA in the circulation and other factors     that indicate whether the rtPA is affecting clotting ability. Blood also is drawn at least     once a day to monitor heparin levels.      To evaluate the impact of treatment on the function of the leg, patients return to the     Rehabilitation Medicine Department and Radiology department at about 6 weeks (4 to 8 week )     and 6 months for clinical and imaging evaluation of impact of therapy on venous function.      The objectives are to determine how well this treatment will restore venous function and     whether this can be done safely- without causing bleeding complications, which have been the     main risks of previous thrombolytic treatments.   "
171440|NCT00082368|"     Background:        -  Tc-94m sestamibi is a radioactive imaging drug approved by the Food and Drug          Administration to help photograph and study bodily functions.        -  Tc-94m sestamibi accumulates in tumor cells and is eliminated from them in much the same          way that some chemotherapy drugs are eliminated from cancer cells in patients with drug          resistance.        -  P-glycoprotein is a protein found on the surface of some cancer cells. The protein          causes the cells to pump out, or reject, some types of chemotherapy drugs.          P-glycoprotein also makes the cells reject sestamibi.        -  Some drugs, including a drug called tariquidar, may block the pumping action of          P-glycoprotein, giving the chemotherapy more time to work. Tariquidar can also help          sestamibi stay in the cells longer.      Objectives:      -To evaluate the use of sestamibi for determining if chemotherapy is being rejected and if     enough of the blocking drugs are present to stop the rejection.      Eligibility:      -Patients18 years of age and older with a tumor 2 cm or larger who are enrolled in or are     eligible for enrollment in an active National Cancer Institute treatment protocol.      Design:        -  Patients have two scans, one before receiving any drugs and a second 1-2 hours after          receiving tariquidar. The second scan is done 72 or more hours after the first. For both          scans, Tc-94m sestamibi is injected into a vein and a series of pictures are taken with          an imaging camera called a PET (positron emission tomography) scanner. The pictures show          where the sestamibi distributes in the body and monitors the effects of tariquidar on          drug resistance. Blood samples are collected during the scan to examine the effect of          tariquidar on P-glycoprotein in normal cells.        -  Some patients may be asked to undergo a tumor biopsy to test for the presence of the          P-glycoprotein on their cancer cells. This will be requested only in patients whose          tumor is easily accessible and in whom a biopsy can be done with minimal risk.   "
171441|NCT00082381|"     This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial     to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as     measured by hemoglobin A1c (HbA1c).   "
171442|NCT00082394|"     The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe,     tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and     atazanavir administered once daily. Over the course of 48 weeks, various parameters that     measure safety, tolerability and efficacy of the investigational drugs were measured and     compared.   "
171443|NCT00082407|"     This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect     of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as     measured by hemoglobin A1c (HbA1c).   "
171489|NCT00083096|"     RATIONALE: Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary     for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to     stop tumor cells from dividing so they stop growing or die. Giving lonafarnib together with     temozolomide may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when     given together with temozolomide in treating patients with recurrent primary supratentorial     glioma.   "
171490|NCT00083109|"     Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells     from dividing so they stop growing or die. Suramin may increase the effectiveness of     fluorouracil by making tumor cells more sensitive to the drug. This phase I/II trial is     studying the side effects and best dose of fluorouracil and the chemosensitizer suramin and     to see how well they work in treating patients with metastatic renal cell (kidney) cancer.   "
171444|NCT00082420|"     To determine vitamin A value of beta-carotene in oil capsule, spinach, and golden rice.      The experiments will be conducted in children (ages 7-9) with/without adequate vitamin A     nutrition. As plant provitamin A carotenoids are a major and safe vitamin A source for a vast     population in the world, it is essential to determine the efficiency of provitamin A     carotenoid (mainly ß-C) conversion to vitamin A. By introducing ß-C into rice endosperm,     Golden Rice may directly benefit consumers by providing vitamin A nutrition. Our     investigation uses hydroponically grown, deca-deuterium labeled spinach and Golden Rice,     synthetic ß-C-d10 and a vitamin A isotope reference, deca-deuterated retinyl acetate     (RAc-d10), to evaluate the bioavailability and the bioconversion of plant provitamin A     carotenes to retinol as compared with ß-C in oil capsules in vivo.      Our objectives will be to test the following hypotheses and to make the following     determinations: (1) The absorption and bio-conversion of provitamin A carotenes taken by     children are different between spinach, Golden Rice, and ß-C in oil capsules. (2) The     absorption of provitamin A carotenes and their bioconversion to vitamin A are different in     children with or without adequate vitamin A nutrition. (3) To define the vitamin A     equivalence(s) of dietary spinach, Golden Rice, and a ß-C in oil dose by using an isotope     reference method in children with or without adequate vitamin A nutrition and to compare     those values with values derived from model based compartmental analysis. (4) To determine     the number and time of blood samples needed for future studies in various field settings on     the retinol equivalence of a large number of plant sources.      This study will be of importance in planning vitamin A deficiency prevention strategies and     also will provide useful information regarding the potential efficacy of a bioengineered crop     to provide vitamin A nutrition.   "
171445|NCT00082433|"     The purpose of this clinical research study is to learn if BMS-247550 added to the approved     therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine     alone in women with metastatic breast cancer. Patients should have previously received an     anthracycline and a taxane. The safety of this treatment will also be studied.   "
171446|NCT00082446|"     The overall goals of this study are to expand the available data on the safety and     immunogenicity of MVA-BN in vaccinia-naive adults and to determine the optimum dose of MVA-BN     to induce immune responses and attenuate Dryvax take reactions. Participants will include 90     healthy volunteers, ages 18-32 years. Participants will be randomly assigned to 1 of 6 study     groups (groups A-F). Participants will be involved in study related procedures for up to 2     years. During this time, volunteers will return periodically for blood draws to check immune     responses.   "
171447|NCT00082459|"     The goal of this trial is to determine the safety of HSPPC-96 and which route of     administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic     agent made from an individual patient's tumor.   "
171448|NCT00082472|"     This study is intended to show whether inhaled chemotherapy can be added to a standard IV     chemotherapy regime, to investigate the additional toxicities and to show initial evidence of     efficacy of the combination.   "
171449|NCT00082485|"     The purpose of this study is to assess the efficacy and safety of baclofen for the treatment     of cocaine dependence.   "
171450|NCT00082498|"     New treatment options are critical for treatment-experienced HIV infected patients with drug     resistance. HIV entry inhibitors have been shown effective in patients with resistance to     other anti-HIV drugs. This study will test the safety and effectiveness of three different     doses of vicriviroc (formerly known as Schering D, SCH-D, or SCH 417690) in HIV infected     patients.   "
171451|NCT00082511|"     Open label safety and efficacy follow-up.   "
171452|NCT00082524|"     This study is an open label, noncomparative study using an investigational agent for the     treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3     months-17 years).   "
171453|NCT00082537|"     This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in     the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute     neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic     coverage. Such patients would be candidates for empirical therapy with an intravenous     anti-fungal agent.   "
171454|NCT00082550|"     This study will compare serotonin transporters in patients with obsessive-compulsive disorder     (OCD) and healthy volunteers in order to better understand the role of serotonin in OCD.     Serotonin is a chemical in the brain that transmits nerve impulses. The serotonin transporter     (SERT) is a protein that regulates serotonin levels in the brain.      Normal, healthy volunteers and patients with OCD between 18 and 50 years of age and in     overall good health may be eligible for this study. Candidates are screened with a medical     history, physical examination, blood and urine tests, and a psychological interview and tests     related to OCD symptoms. Participants undergo the following tests:        -  Positron emission tomography (PET) scanning: For this test, subjects lie on the scanner          bed, wearing special masks that are fitted to their heads and attached to the beds to          help keep their heads still during the procedure. An 8-minute transmission scan is          done to provide measures of the brain that will help calculate information obtained from          subsequent scans. Then, a radioactive tracer is injected into a catheter (plastic tube)          placed in the arm. The scan produces images of the serotonin transporters in the brain.          Pictures are taken for about 2 hours, while the subject lies still on the scanner bed.        -  Magnetic resonance imaging (MRI) scanning: An MRI scan of the brain is done within 1          year of the PET scan-that is, up to 1 year before or 1 year after the PET scan. MRI uses          a magnetic field and radio waves to produce images of body tissues and organs. For this          procedure, the patient lies on a table that is moved into the scanner (a narrow          cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur          during the scanning process. The procedure lasts about 1 hour, during which the patient          will be asked to lie still for up to a few minutes at a time.        -  Genotyping: Subjects provide a blood sample (4 tablespoons) for DNA testing to look for          genes or gene regions that may contribute to serotonin activity. This may lead to a          better understanding of the genetic underpinnings of the serotonin system that influence          mood, movement, and addiction.   "
171455|NCT00082563|"     The purpose of this study is to determine if Azithromycin in combination with chloroquine is     superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in     asymptomatic, semi-immune adults in Western Kenya.   "
171456|NCT00082576|"     The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is     non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P.     falciparum.   "
171457|NCT00082589|"     The purpose of this study is to determine if eplerenone is effective in the treatment of mild     to moderate heart failure   "
171458|NCT00082602|"     The purpose of this study is to evaluate the safety and tolerability of an extended release     formulation of the drug galantamine using a rapid dose escalation regimen.   "
171471|NCT00082810|"     This phase II trial is studying how well giving tipifarnib together with fulvestrant works as     second-line therapy in treating postmenopausal women with hormone receptor-positive     inoperable locally advanced or metastatic breast cancer that has progressed after previous     first-line endocrine therapy. Tipifarnib may stop the growth of tumor cells by blocking the     enzymes necessary for their growth. Estrogen can stimulate the growth of breast cancer cells.     Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen.     Combining tipifarnib with fulvestrant may kill tumor cells that did not respond to first-line     therapy.   "
171472|NCT00082823|"     RATIONALE: Intravenous VEGF Trap may stop the growth of solid tumors or non-Hodgkin's     lymphoma by stopping blood flow to the cancer.      PURPOSE: This phase I trial is studying the side effects of VEGF Trap in treating patients     with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.   "
171459|NCT00082615|"     This study will use a technique called blink reflex to study and compare how the brain     controls muscle movement in patients with craniofacial dystonia, their first-degree     relatives, and healthy, normal volunteers. People with dystonia have sustained muscle     contractions that cause twisting and repetitive movements or abnormal postures. In focal     dystonia, this happens in one area of the body, such as the hand, neck, or face.      Three groups of people may be eligible for this study: 1) patients 18 years of age and older     with craniofacial dystonia; 2) first-degree relatives of patients with craniofacial dystonia;     and 3) normal volunteers matched in age to the patients. Candidates are screened with     physical and neurological examinations.      Participants undergo a blink reflex study. Patients with dystonia who are receiving botulinum     toxin injections must stop the medication 3 months before participating in the study and must     stop any other dystonia medications, such as benzodiazepines and anticholinergics, for 12     hours before the study. For the blink reflex procedure, subjects are seated in a comfortable     chair with their hands placed on a pillow on their lap. Metal electrodes are taped to the     forehead for delivering small electrical shocks that feel like very brief pinpricks. Subjects     receive 25 to 50 electrical stimuli, some as single shocks and some in pairs. The electrical     activity of muscles that respond to the stimuli is recorded with a computer. The study takes     from about 1 to 2 hours.   "
171460|NCT00082628|"     The primary objective of the study is to determine if Serostim® 4 mg administered daily for     12 weeks as treatment for the abnormal fat accumulation and distribution associated with     HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT,     measured by CT scan) more effectively than placebo.   "
171461|NCT00082641|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs     used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in     different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy before and/or     after chemotherapy and radiation therapy may cause a stronger immune response.      PURPOSE: This randomized phase I/II trial is studying the side effects of two regimens of     vaccine therapy and to see how well they work in treating women who are receiving neoadjuvant     or adjuvant chemotherapy and adjuvant radiation therapy for stage III breast cancer that     overexpresses p53.   "
171462|NCT00082654|"     RATIONALE: Understanding the emotional needs of spouses or others who are living with and     caring for patients who have undergone stem cell transplantation may help improve the quality     of life of both the caregivers and the patients.      PURPOSE: This clinical trial is studying the emotional needs of caregivers of patients who     have undergone stem cell transplant.   "
171463|NCT00082667|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. It is not yet known whether surgery is more effective with or without gefitinib     in treating ductal carcinoma in situ.      PURPOSE: This randomized phase II trial is studying how well gefitinib together with surgery     works compared to surgery alone for the treatment of women with ductal carcinoma in situ of     the breast.   "
171464|NCT00082706|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, gemcitabine, and     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or     die. Combining more than one drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving fluorouracil together with     leucovorin, gemcitabine, and cisplatin works in treating patients with metastatic or     unresectable adenocarcinoma of the urothelium or urachal remnant (part of the bladder).   "
171465|NCT00082719|"     RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth     of urothelial cancer.      PURPOSE: This randomized phase I trial is studying how well low-dose interferon alfa works in     treating patients with cancer of the urothelium.   "
171466|NCT00082732|"     RATIONALE: A low-fat, high-fiber diet that includes soy protein may prevent disease     progression in patients with hormone-refractory prostate cancer. Nutrition counseling may     help motivate patients to follow this diet.      PURPOSE: Randomized phase I trial to study the effectiveness of behavior-based dietary     interventions, such as receiving nutrition counseling, in helping patients who have     hormone-refractory prostate cancer follow a low-fat, high-fiber, soy-supplemented diet.   "
171467|NCT00082745|"     This clinical trial studies cancer survivors to identify those who are at increased risk of     developing late-occurring complications after undergoing treatment for childhood cancer. A     patient's genes may affect the risk of developing complications, such as congestive heart     failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment.     Genetic studies may help doctors identify survivors of childhood cancer who are more likely     to develop late complications.   "
171468|NCT00082758|"     RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein work in     different ways to stimulate the immune system and stop tumor cells from growing.      PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works     in treating young patients with recurrent or refractory neuroblastoma.   "
171469|NCT00082784|"     Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their     growth. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop     cancer cells from dividing so they stop growing or die. Bortezomib may increase the     effectiveness of flavopiridol by making cancer cells more sensitive to the drug. Giving     bortezomib together with flavopiridol may kill more cancer cells. This phase I trial is     studying the side effects and best dose of bortezomib and flavopiridol in treating patients     with recurrent or refractory indolent B-cell neoplasms.   "
171470|NCT00082797|"     RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop     tumor cells from dividing so they stop growing or die. Leucovorin may decrease side effects     caused by high-dose methotrexate.      PURPOSE: This phase II trial is studying how well giving high-dose methotrexate together with     leucovorin works in treating patients with newly diagnosed glioblastoma multiforme.   "
171473|NCT00082836|"     RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan,     can locate cancer cells and either kill them or deliver radioactive cancer-killing substances     to them without harming normal cells.      PURPOSE: This clinical trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan     together with rituximab works in treating patients with recurrent primary CNS lymphoma.   "
171474|NCT00082862|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine, work in different     ways to stop tumor cells from dividing so they stop growing or die. Giving low-dose     interferon alfa on a metronomic (regularly timed) schedule may stop the growth of cancer by     stopping blood flow to the tumor. Fever-range (above 101° F) whole-body hyperthermia kills     tumor cells by heating them to several degrees above normal body temperature. Combining     cisplatin, gemcitabine, and low-dose interferon alfa with fever-range whole-body hyperthermia     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cisplatin, gemcitabine, and     metronomic low-dose interferon alfa together with fever-range whole-body hyperthermia works     in treating patients with inoperable or metastatic pancreatic cancer.   "
171475|NCT00082875|"     This randomized phase II trial is studying how well cilengitide works in treating patients     with unresectable stage III or stage IV melanoma. Cilengitide may stop the growth of melanoma     by stopping blood flow to the tumor.   "
171476|NCT00082888|"     This phase II trial studies how well tipifarnib works in treating patients with relapsed or     refractory non-Hodgkin's lymphoma. Tipifarnib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Tipifarnib may be an effective treatment for     non-Hodgkin's lymphoma.   "
171477|NCT00082914|"     RATIONALE: Denileukin diftitox may be able to make the body build an immune response to kill     tumor cells.      PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating     patients with metastatic melanoma or metastatic kidney cancer.   "
171478|NCT00082927|"     RATIONALE: Ibandronate may be effective in reducing bone pain caused by metastatic cancer.     Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether     ibandronate is more effective than standard treatment with radiation therapy in treating     metastatic bone pain.      PURPOSE: This phase III randomized clinical trial is studying ibandronate to see how well it     works compared to single-dose local radiation therapy in treating patients with localized     metastatic bone pain.   "
171479|NCT00082940|"     RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth     of cancer cells and slow the growth of chronic lymphocytic leukemia.      PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating     patients with fludarabine-refractory B-cell chronic lymphocytic leukemia.   "
171480|NCT00082966|"     Phase II trial to study the effectiveness of bortezomib in treating patients who have     relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by     blocking the enzymes necessary for their growth.   "
171481|NCT00082979|"     RATIONALE: Diagnostic procedures, such as breast duct endoscopy, may improve the ability to     detect breast cancer earlier and plan more effective treatment.      PURPOSE: This phase II trial is studying how well breast duct endoscopy works in assessing     cellular atypia (abnormal cells) in the breast ducts of women with a genetic risk for breast     cancer.   "
171482|NCT00083005|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and estramustine, work in different     ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the     growth of prostate cancer by stopping blood flow to the tumor. Giving chemotherapy together     with thalidomide may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together     with thalidomide works in treating patients with androgen-independent metastatic     adenocarcinoma (cancer) of the prostate.   "
171483|NCT00083018|"     RATIONALE: Diagnostic procedures, such as nipple aspiration, ductal lavage, and breast duct     endoscopy, may help doctors detect and assess breast cancer cells early and plan more     effective treatment.      PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct     endoscopy work in assessing cancer cells in women who are undergoing surgery for breast     cancer.   "
171484|NCT00083031|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in     different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may     stop the growth of breast cancer by stopping blood flow to the tumor. Giving metronomic     (regularly timed) low-dose cyclophosphamide and methotrexate together with bevacizumab may     kill more tumor cells.      PURPOSE: This randomized phase II trial is studying metronomic low-dose cyclophosphamide and     methotrexate to see how well they work compared to metronomic low-dose cyclophosphamide,     methotrexate, and bevacizumab in treating women with metastatic breast cancer.   "
171485|NCT00083044|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of or treat early cancer. Diagnostic procedures, such as ductal lavage, may     improve the ability to assess the effectiveness of chemopreventive drugs, such as tamoxifen,     on breast cells and may help doctors plan more effective treatment.      PURPOSE: This phase II trial is studying how well ductal lavage works in assessing changes in     breast cells in women with early breast cancer or in those at high risk of developing breast     cancer who are eligible for tamoxifen therapy.   "
171486|NCT00083057|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy     x-rays to damage tumor cells. Giving gefitinib and paclitaxel together with radiation therapy     may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib and     paclitaxel when given together with radiation therapy in treating patients with advanced or     recurrent squamous cell carcinoma (cancer) of the head and neck.   "
171487|NCT00083070|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     cancer cells from dividing so they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide in     treating young patients with refractory or recurrent leukemia.   "
171488|NCT00083083|"     RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography     (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict     a patient's response to treatment and plan more effective treatment.      PURPOSE: This phase II trial is studying how well ^18FDG-PET imaging works in detecting     disease progression and determining response to treatment in patients who are undergoing     chemoradiotherapy for locally advanced non-small cell lung cancer.   "
179523|NCT00185107|"     Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol   "
171491|NCT00083122|"     This phase II trial is studying how well giving cisplatin together with flavopiridol works in     treating patients with advanced ovarian epithelial cancer or primary peritoneal cancer. Drugs     used in chemotherapy, such as cisplatin and flavopiridol, work in different ways to stop     tumor cells from dividing so they stop growing or die. Combining more than one drug may kill     more tumor cells.   "
171492|NCT00083135|"     RATIONALE: Giving iodine I 131 metaiodobenzylguanidine (^131I-MIBG) may kill neuroblastoma     cells by delivering radiation directly to the tumor. A stem cell transplant using the     patient's stem cells may be able to replace blood-forming cells destroyed by radiation     therapy.      PURPOSE: This phase I trial is studying the side effects and best dose of a double infusion     of ^131I-MIBG followed by autologous stem cell transplantation in treating patients with     refractory neuroblastoma.   "
171493|NCT00083148|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different     ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may help     capecitabine kill more tumor cells by making tumor cells more sensitive to the drug.      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan and     capecitabine in treating women with advanced breast cancer.   "
171494|NCT00083161|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and cyclophosphamide,     work in different ways to stop tumor cells from dividing so they stop growing or die.     Combining more than one chemotherapy drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cisplatin, etoposide, and     cyclophosphamide together works in treating patients with extensive-stage small cell lung     cancer.   "
171495|NCT00083174|"     RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may     prevent breast cancer by blocking the production of estrogen. This study was analyzed in     April 2011 and showed a 65% reduction in the incidence of invasive breast cancer in women     receiving exemestane compared to women on placebo.      PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is     to allow all study participants the opportunity to complete 5 years of exemestane.   "
171496|NCT00083187|"     RATIONALE: Drugs used in chemotherapy, such as VNP40101M and hydroxyurea, work in different     ways to stop cancer cells from dividing so they stop growing or die. Hydroxyurea may help     VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug.      PURPOSE: This phase II trial is studying how well giving VNP40101M with hydroxyurea works in     treating patients with acute myelogenous leukemia or high-risk myelodysplasia.   "
171497|NCT00083213|"     RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by     stopping blood flow to the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of intravenous VEGF     Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's     lymphoma.   "
171498|NCT00083226|"     This phase II trial is studying how well giving doxorubicin together with bortezomib works in     treating patients with liver cancer. Drugs used in chemotherapy, such as doxorubicin, work in     different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may     stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving     doxorubicin together with bortezomib may kill more tumor cells.   "
171499|NCT00083239|"     The purpose of this study is to assess the antitumor activity and safety of talabostat in     patients with metastatic melanoma.   "
171500|NCT00083252|"     The purpose of this study is to assess the antitumor activity and safety of the combination     of talabostat and cisplatin in patients with metastatic melanoma.   "
171501|NCT00083265|"     This study will try to identify genes that increase the risk of developing panic disorder-an     anxiety disorder characterized by recurrent unexpected panic attacks-and that contribute to     the abnormalities associated with it. It will compare reactions in patients with panic     disorder and in normal volunteers to caffeine, a compound that can induce anxiety, and to     placebo, an inactive substance. Caffeine is believed to induce anxiety by blocking proteins     called adenosine receptors on the surface of nerve cells in the brain. One study found that     people with a specific adenosine receptor gene called 1976T/T had greater anxiety in response     to caffeine challenge than did people with other adenosine receptor gene groups. There is     also evidence that people with the 1976T/T genotype are more vulnerable to having panic     disorder.      Normal volunteers and patients with panic disorder (with or without agoraphobia) who are     between 18 and 60 years of age may be eligible for this study. Candidates are screened with     physical and psychiatric examinations, a diagnostic interview, mood and anxiety ratings, an     electrocardiogram, and blood and urine tests, including genetic studies.      Participants have two caffeine/placebo challenge sessions at least 3 days apart. Each session     lasts about 4 hours. For at least 1 week before each session, subjects follow a diet     excluding foods with caffeine and refrain from drinking alcoholic beverages for at least 48     hours before the procedure. The morning of the session, following an overnight fast, subjects     swallow either a placebo capsule or a caffeine capsule that is equivalent to about 5 cups of     coffee. During the session, subjects take a battery of neuropsychological tests to document     changes in cognitive and emotional functioning, including attention, memory, and motor     performance. In addition, heart rate and blood pressure are measured 15 minutes before and     30, 60, 90, 120, 150, and 180 minutes after the caffeine or placebo dose.      At the end of the study, patients with panic disorder are eligible to receive routine     clinical treatment for up to 3 months and may participate in planning for long-term treatment     under the care of their local health care provider.   "
171502|NCT00083278|"     This Phase II study is designed to treat patients who have been diagnosed with Stage IV     Breast Cancer, which has progressed despite treatment with primary therapies, including     hormonal therapy, chemotherapy, and antibody therapy. Thirty-three patients will be treated     with the monoclonal antibody MDX-010. The initial antitumor activity profile of MDX-010 will     be determined, as well as identification of the induction of any antitumor immunity following     the MDX-010 treatment.   "
171545|NCT00083863|"     To investigate the contribution of genetic and environmental factors to vascular     inflammation, and to define the extent to which inflammatory phenotypes and genotypes predict     subclinical and clinical cardiovascular disease (CVD).   "
171546|NCT00083876|"     This study has been designed to evaluate whether combination chemotherapy and     anti-angiogenesis therapy with thalidomide is equal or superior to autologous     transplantation for the treatment of multiple myeloma.   "
171547|NCT00083889|"     The purpose of this study is to test whether SU011248 has activity and is safe compared to     interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).   "
171600|NCT00078013|"     This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The     primary objectives of this study are to examine the safety, tolerability, and efficacy of     intravenous MCC-135 in limiting final infarct size, as measured by single photon emission     computed tomography (SPECT), in patients who require percutaneous coronary intervention (PCI)     for a first-documented ST-segment elevation acute myocardial infarction (AMI).   "
171503|NCT00083291|"     This study will examine whether infection with Helicobacter pylori bacteria may cause     inflammation of the eye's surface. Although most people who are infected with H. pylori do     not have symptoms, the bacteria can cause several diseases, including gastritis-stomach     inflammation, stomach ulcers or, rarely, stomach cancer, and certain types of lymphoma. H.     pylori has also been associated with autoimmune disorders, in which the patient's immune     system attacks the body's own tissues.      People who have been infected with H. pylori, with and without dry eye, may be eligible for     this study. Candidates are screened with a medical history, a blood test to determine H.     pylori infection, and an eye examination. The examination includes measurements of visual     acuity, eye pressure, and tear production. To measure the amount of tear production, a small     piece of filter paper is inserted over the eyelid on the side and collects tears over a     5-minute period. Drops of two colored dyes (orange and green) are placed in the eyes to see     if there are any dry areas. Screening also includes examination of the pupils and eye     movements, the lens, and the back of the eye, including the retina.      Participants will also have a few cells collected from the surface of the eye. After the eyes     are numbed with anesthetic eye drops, a swab (like a Q-tip) is rolled over the surface of the     white part of the eye to collect small samples of the superficial layer of the conjunctiva -     a transparent membrane covering the eyeball. The specimens are analyzed by special laboratory     techniques to determine whether H. pylori has infected the eye.   "
171504|NCT00083304|"     RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3,     randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer     patients with brain metastases in that trial, 59 patients who received RSR13 prior to     radiation therapy had a median survival time that was twice as long as the 52 patients who     did not receive RSR13 prior to radiation therapy.      RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from     blood into the tissues. It is well known that certain types of cancer tumors, including those     in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of     radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation     therapy works better.      This study will enroll up to 360 women with brain metastases from breast cancer, and will     evaluate if whole brain radiation therapy given with RSR13 will have a better treatment     effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV)     through a central catheter placed in a central vein. Women randomized (assigned) to receive     RSR13, therefore, will need to have a central catheter placed for treatment unless one is     already in place.   "
171505|NCT00083317|"     This study will identify which areas of the brain mediate the interaction between people     involved in economic decision-making.      Healthy, right-handed native English speakers between 21 and 55 years of age may be eligible     for this study. Candidates are screened with a telephone interview, a questionnaire to     determine handedness, and a neurological examination if one has not been performed within the     last year by an NIH physician.      Participants bargain for money by playing two-person trust games, while undergoing functional     magnetic resonance imaging (fMRI). MRI uses a strong magnetic field and radio waves to obtain     images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong     magnetic field. During the procedure, the subject lies on a stable that can slide in and out     of the scanner, wearing earplugs to muffle loud knocking sounds that occur with electrical     switching of the magnetic fields. Functional MRI involves taking MRI scans while the subject     performs a task-this to learn about how the brain regions are involved in performing the     task. For this test, the subject plays or watches two-person games involving trust. The game     may be played against a stranger or a friend. The winner receives a cash payoff.      The subject performs one of the following two tasks during MRI scanning:        -  Playing the trust games and indicating as quickly as possible by pressing a right or          left button whether he or she wants to stop or continue playing, or        -  Observing games that others have played and predicting as quickly as possible by          pressing a right or left button whether the players wanted to stop or continue the          games.      The test takes about 90 minutes. After the scan, participants complete written questionnaires     about their experience in the scanner and their views on issues related to participating in     competitive games.   "
171506|NCT00083330|"     This study will test the safety of an experimental vaccine against HIV infection and see if     it causes an immune response to HIV. The vaccine is given by injection (shot) in the upper     arm. It is made from DNA that codes for three HIV proteins. The DNA is inserted into an     adenovirus that carries it into the muscle cells. The adenovirus normally can cause eye or     upper respiratory infections, such as a cold; however, for the vaccine, it has been modified     so that it cannot cause illness. Nor can the vaccine cause HIV infection, because it codes     for only three of the nine HIV proteins.      Healthy, normal volunteers between 18 and 44 years of age who are not HIV-infected may be     eligible for this study. Candidates are screened with a medical history and physical     examination and blood and urine tests.      Participants are randomly assigned to receive either the experimental vaccine or a placebo     (an inactive substance that looks like the vaccine). The vaccine or placebo is administered     to participants in groups, according to their entry into the study. The first group receives     the lowest study dose of vaccine. If this dose is safe, then the second group receives a     higher dose. If this dose is also safe, then the third and final group receives the highest     study dose. Clinic staff observe the subjects for side effects for 30 minutes after the     injection, and subjects keep a diary card for the next 5 days, recording their temperature     and any symptoms that may appear. Subjects are contacted by a nurse 2 days after the     injection for follow-up.      Participants are seen at the clinic for follow-up visits 1, 2, 4, 12, and 24 weeks after the     injection, and then are contacted by telephone for follow-up once a year until 5 years after     the injection. The clinic visits include a physical examination, medical history, blood and     urine tests, and HIV counseling, as needed. Women have pregnancy tests at the screening     evaluation and again at study week 24. All subjects are tested for HIV at screening and at     study weeks 12 and 24, and all subjects complete a social impact questionnaire at week 24.     All subjects are asked questions about their sexual behavior and drug use.   "
171507|NCT00083343|"     Candida is the most common fungal pathogen identified in hospitalized patients. This study     will seek to enroll adult patients (18 years of age or older) with invasive Candida     infections (involving deep tissues and organs). The study will not enroll patients whose only     site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria     will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin     antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage     strength and duration of caspofungin will be individualized for each patient based on     disease, severity of disease and extent of infection.   "
171548|NCT00083902|"     The purpose of this investigational trial is to find out how well patients respond and how     long their response lasts when treated with a standard regimen of dexamethasone with or     without thalidomide and also find out what kind of side effects patients will experience.   "
171549|NCT00083915|"     The purpose of this study is to find out if transplant with a new regimen of chemotherapy     called DT PACE-Melphalan is better than transplant with Melphalan alone. Another purpose of     this study is to find out if there will be fewer side effects with the new regimen of DT     PACE-Melphalan, compared to melphalan alone.   "
171550|NCT00083928|"     The purpose of this study is to determine whether injections of Å6 are effective in treating     ovarian cancer patients who have completed first-line therapy and currently have no     detectable cancer but have experienced a doubling of CA 125 levels.   "
171508|NCT00083356|"     This study will examine whether bradykinin receptors are produced at the site of wisdom tooth     extraction and if they contribute to the amount of inflammation and pain that follows     surgery. Bradykinin is a molecule produced by enzymes at the site of an injury and then binds     to receptors to cause pain. The study will also evaluate the role of genetic factors in the     production of bradykinin and their receptors and the pain associated with minor surgical     procedures.      Patients between 16 and 35 years of age who are referred to the NIH dental clinic for removal     of two wisdom teeth may be eligible for this study. Candidates must be in good health and     must not be allergic to aspirin, non-steroidal anti-inflammatory drugs, sulfites, or amide     anesthetics. They will be screened with a medical history and oral examination, including     x-rays to confirm the need for wisdom tooth extraction.      On the morning of surgery following an overnight fast, participants have a blood sample drawn     to extract DNA for gene studies. Just before surgery, they are given an intravenous (IV)     sedative to induce drowsiness and a local anesthetic to numb the mouth. They are also given     IV either Ketorolac, a non-steroidal anti-inflammatory drug, or placebo, a look-alike     medication with no active ingredient. After the extractions, a small piece of plastic tubing     is placed in both extraction sites, and every 20 minutes for the next 3 hours inflammatory     fluid is collected from the tubing for measuring chemicals believed to cause pain and     swelling. Patients rate their pain by answering pain-related questions every 20 minutes.     Patients who have pain that is not relieved by the study medication (Ketorolac or placebo)     are given, upon request, 50 mg of the pain reliever tramadol (Ultram). Patients remain in the     clinic for at least 3 hours and no more than 7 hours after surgery in order for monitoring     the effects of the study drugs as the local anesthetic wears off.      Patients undergo two biopsies during the study - one before and one after the extraction - to     measure any changes in chemicals produced in response to the surgery. The second biopsy is     done either 3, 7, or 24 hours after the extraction. Patients in the 3- and 7-hour groups are     given a small dose of local anesthetic in the gum for the second biopsy and remain in the     clinic until the biopsy is done; those in the 24-hour group are given forms to record pain     ratings at home and return to the clinic the following morning for a 2-hour follow-up visit.     All patients are given standard pain medication (flurbiprofen) to take at home.   "
171509|NCT00083369|"     To characterize the genetic basis of the variable response of triglycerides to two     environmental contexts, one that raises triglycerides (dietary fat), and one that lowers     triglycerides (fenofibrate treatment.)   "
171510|NCT00083382|"     The purpose of this research is to study how helpful the combination of thalidomide and     Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any     side effects.   "
171511|NCT00083395|"     This study will examine the usefulness of a new test called an isoproterenol challenge in     patients with arrhythmogenic right ventricular cardiomyopathy (ARVC) and family members who     may have the disease but do not have clear-cut evidence of it. ARVC is a rare condition that     runs in families. Heart muscle is replaced with fatty, scar-like tissue, especially in the     right ventricle (lower pumping chamber of the heart), and can sometimes extend to the left     ventricle (the main pumping chamber). The fat can interfere with the heartbeat, producing     abnormal heart rhythms, such as ventricular tachycardia (VT) - a very fast heartbeat that can     cause sudden death, especially in young people. Isoproterenol is a drug that increases heart     rate and heart muscle contractions. In isoproterenol challenge, subjects are given increasing     doses of the drug through a catheter (see details below) to try to produce an abnormal heart     rhythm.      ARVC is hard to diagnose with current tests. This study will see if isoproterenol challenge     provokes VT in patients with the disease and can confirm the diagnosis; if it can detect the     disease in family members better than currently available tests; and if it provokes abnormal     rhythms in healthy control subjects. In addition, the study will explore the genetics of ARVC     and determine whether infection could contribute to its development.      Patients with ARVC, their family members, and normal volunteers 18 years of age and older may     be eligible for this study. Candidates are screened with a medical history and physical     examination, electrocardiogram (EKG), treadmill and bicycle exercise testing, and an     echocardiogram (ultrasound test of the heart).      Participants undergo the following tests and procedures:        -  Blood tests - Blood is collected to study the genetics of ARVC, to test for evidence of          old infections, and to measure brain natriuretic peptide - a hormone that can increase          with development of heart failure.        -  Heart magnetic resonance imaging (MRI). This test looks at heart structure and function.          MRI uses a magnetic field and radio waves to produce images of body tissues and organs.          The subject lies on a table that is moved into the scanner (a narrow cylinder), wearing          earplugs to muffle loud knocking sounds that occur during the scanning process. At some          time during the test, the subject is given a contrast agent called gadolinium through a          catheter (thin, flexible tube) in a vein to improve the scan pictures. The scan time          varies from 30 to 90 minutes, with most scans lasting 60 minutes. (Control subjects do          not undergo MRI.)        -  Isoproterenol challenge. Subjects are given increasing doses of isoproterenol through a          catheter until the heart rate reaches 100 to 120 beats per minute for no more than 1          hour. A special EKG records heart rhythm during the test and an echocardiogram records          right and left ventricular function.        -  QRST surface mapping EKG. This special EKG, done with 64 or 120 leads, maps          abnormalities of heart rhythm and cardiac conduction during the isoproterenol challenge.          These tests are like a regular EKG, except that more leads are placed on the chest, and          on the back as well.      Patients and family members who wish to have follow-up visits may return to the NIH Clinical     Center once a year for 5 years for guidance about therapy based on clinical considerations     and new information or investigations.   "
171512|NCT00083408|"     The purpose of this research is to study how helpful the combination of thalidomide and     Pamidronate is in controlling multiple myeloma and to study any side effects that may be     experienced.   "
171513|NCT00083421|"     The purpose of this study is to establish the presence of an effect of treatment with     ONO-2506PO in patients with Alzheimer's Disease, based upon cognitive and global scales.   "
171514|NCT00083434|"     The purpose of this study is to examine the effectiveness of epoetin alfa in treating anemia     in patients who have cancer or who no longer have any signs of the cancer, but remain anemic     as a result of their treatment.   "
171515|NCT00083447|"     TransMID treatment or best standard of care for patients with advanced glioblastoma     multiforme      Glioblastoma multiforme (GBM) is a type of brain tumour. GBM tumours are usually treated with     surgery and radiotherapy. Unfortunately, this type of brain tumour may continue to grow or     come back (recur) despite treatment.      This trial will compare a new drug called TransMID with the best standard treatment that is     currently available. TransMID is a drug that is a combination of a protein called transferrin     and a poison called diphtheria toxin.      Cancer cells need iron in order to continue to grow. They need more iron than normal cells.     Transferrin helps cells to take up available iron. So the cancer cells are attached to the     transferrin in TransMID, and the diphtheria poison kills them. The aim of this treatment is     to kill the cancer cells while not affecting the normal brain cells. This treatment for brain     tumours may have fewer side effects than other treatments because it targets cancer cells.      The best standard treatment will involve giving chemotherapy. You may have chemotherapy as     part of the treatment when you are diagnosed. Or it may be kept in reserve to treat your     brain tumour if it comes back or continues to grow. Your cancer specialist (consultant) will     decide which chemotherapy drugs you should have.   "
171516|NCT00083460|"     The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses     of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate     doses of PS-341 and thalidomide in the combination.   "
171517|NCT00083473|"     This pilot study will assess the safety and efficacy of Pivanex alone in patients with     chronic lymphocytic leukemia (CLL) who have relapsed or refractory disease after previous     chemotherapy treatment. Pivanex is an investigational agent.   "
171518|NCT00083486|"     The purpose of this study is to determine the effectiveness of different doses of epoetin     alfa for treating anemia in patients who have cancer; or patients who no longer have any     signs of cancer, but remain anemic as a result of their treatment. These patients should not     be currently receiving chemotherapy or radiotherapy. A subject's participation in the study     will last approximately 6 months. Subjects will receive weekly doses of epoetin alfa or     placebo. Their hemoglobin will be tested every week.   "
171519|NCT00083499|"     This study will collect blood, urine, and other tissue samples from patients with Pentalogy     of Cantrell (POC) and other inherited diseases that may involve mutations in non-muscle     myosin II-B heavy chain (MYH10). We will also collect samples from the relatives of affected     individuals. POC is a very rare disorder in which patients have a combination of severe     defects of the middle of the chest including the sternum (breastbone), diaphragm, heart, and     abdominal wall. The defect are apparent before birth or at birth.      Participants may undergo a medical evaluation that could include a medical history routine     blood tests, urine collection, chest x-ray, and electrocardiogram. In addition, blood, urine,     saliva, buccal swab or tissue samples may be collected for protein and gene studies. The     blood is drawn through a very small needle placed in an arm vein. Children may choose to have     a buccal (cheek) sample taken instead of blood draw. Buccal samples can be collected by a     cheek swab, in which a soft brush is rubbed on the inside lining of the mouth, or by having     the child hold a tablespoon of mouthwash in his or her mouth for a full minute and then spit     the mouthwash into a container. In addition, tissue samples may be collected from patients if     they undergoing any surgical procedures that may be required as part of their general medical     care.      Some of the cells obtained from patients or their relatives may be used to establish cell     lines (a living tissue sample) that can be grown in the laboratory and used for experiments.   "
171576|NCT00084279|"     To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha     and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who     are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin.   "
179524|NCT00186303|"     To evaluate the role of high dose therapy and autologous or allogeneic hematopoietic cell     transplantation for the treatment of chronic lymphocytic leukemia.   "
171520|NCT00083512|"     This study will collect blood and urine samples from patients undergoing radiation therapy     for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this     treatment on blood cells and certain proteins. The information from this study may help     scientists develop new tests to measure radiation exposure and find new ways to treat cancer     with radiation, and help determine which kinds of patients or tumors respond better to     radiation therapy. Two proteins of particular interest in this study and which may be     involved in the recurrence of cancer are VEGF (vascular endothelial growth factor) and MMPs     (matrix metalloproteinases).      Patients 18 years of age and older with glioblastoma multiforme who are receiving or will     receive radiation therapy as part of their medical treatment may be eligible for this study.     Candidates are screened with a history and physical examination, blood tests, and magnetic     resonance imaging (MRI) of the brain.      Participants will have blood and urine samples collected before, during and after completion     of their radiation treatment. Urine samples are collected in a cup and about 2 tablespoons of     blood are withdrawn through a needle in a vein. Additional samples may be requested at     different times during treatment and in the 3-year follow-up period.   "
171521|NCT00083525|"     The purpose of this study is to determine the safety, tolerability, maximum tolerated dose     (MTD), pharmacokinetics, and pharmacodynamics of the combination of WX-UK1 and capecitabine     in patients with advanced malignancies.   "
171522|NCT00083538|"     The purpose of this study is to determine if vaccination with autologous idiotype- or tumor     lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor     immunologic responses.   "
171523|NCT00083551|"     This study has been designed to evaluate whether anti-angiogenesis therapy with thalidomide     and whether additional chemotherapy after transplant will be beneficial. Another objective is     to find out what kinds of side effects occur with this combination of treatment and how often     they occur.   "
171524|NCT00083564|"     STR (Skeletal Targeted Radiotherapy, 166Ho-DOTMP) is an investigational radiopharmaceutical     that delivers radiation directly to cancer cells in the bone and bone marrow. Conventional     methods of delivering radiation therapy, such as total body irradiation, expose non-target     tissues to radiation and cause serious side effects. In contrast, STR's targeted approach to     delivering radiotherapy concentrates the radiation where it is needed, and minimizes exposure     of normal tissues.      STR is composed of a bone-targeting molecule, DOTMP, in a stable complex with the     radionuclide holmium-166. When injected into a patient's bloodstream, STR rapidly binds to     bone mineral, delivering a brief, intense dose of radiation to destroy cancer cells in the     bone and marrow. The high-energy and long path-length of holmium-166 beta particles provide     optimal penetration and uniform irradiation of disease sites in the marrow and bone. STR that     does not bind to bone is rapidly eliminated through the urinary tract. STR treatment is     followed by autologous stem cell transplantation. The short half-life of holmium-166 allows     treatment on an out-patient basis, and minimizes the time required between STR administration     and transplantation.      The phase III study of STR is a multi-center, randomized, controlled study, designed to     evaluate the safety and efficacy of STR in patients with primary refractory multiple myeloma.     These are patients who have failed to achieve at least a partial response to conventional     therapy and have been undergoing treatment for less than 18 months. The trial is expected to     enroll approximately 240 evaluable patients, half on the experimental arm and half on the     control arm. Patients on the experimental arm will receive STR at a dose of 750 mCi/m2 plus     the chemotherapy drug melphalan at 200 mg/m2, followed by autologous stem cell     transplantation. Patients on the control arm will receive melphalan only, followed by     transplantation. Patients on both study arms will be evaluated for response to treatment six     months after transplantation, using an immunofixation assay to detect myeloma protein in     patient samples. Analysis of patient samples will be conducted at a central laboratory, and     blinded results will be reviewed by an independent panel of experts. The study's primary     endpoint is complete response, as determined by the complete disappearance of myeloma protein     at six months post-transplant.   "
171525|NCT00083577|"     The purpose of this research is to study how helpful thalidomide is in controlling the     myeloma disease and to study any side effect resulting from thalidomide.   "
171526|NCT00083590|"     The present study will evaluate the safety and efficacy of the Chinese herb huperzine A in     the treatment of Alzheimer's disease (AD) in a randomized controlled trial of its effect on     cognitive function.   "
171527|NCT00083603|"     The purpose of this study is to evaluate the safety of and immune response to two HIV vaccine     formulations, rMVA-HIV and rFPV-HIV, alone and in combination, in HIV uninfected adults.   "
171528|NCT00083616|"     The purpose of this study is to determine that panitumumab will have clinically meaningful     anti-tumor activity in patients with metastatic colorectal cancer who have developed     progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and     oxaliplatin chemotherapy.   "
171529|NCT00083629|"     This study will examine the use of a new radioactive tracer called [18F]FECNT in positron     emission tomography (PET) scanning for measuring dopamine transporter (DAT) in the brain. DAT     is found in brain neurons (nerve cells) that release the chemical messenger dopamine. By     taking pictures of the DAT, scientists hope to learn more about the function of these     neurons.      Normal, healthy volunteers between 18 and 65 years of age may be eligible for this study.     Candidates are screened with a medical history and physical examination, psychological     assessment, and blood and urine tests.      Subjects enrolled in the study participate in one of the following procedures:      Brain Imaging Study: Part 1      Two catheters (small plastic tubes) are placed into veins in the subject's arms for injecting     [18F]FECNT and for collecting blood samples during the scan. A third catheter is placed into     a wrist artery to obtain arterial blood during the scan. With the catheters in place, the     subject lies down on the scanner bed with his or her head placed in a special mask that     limits movement during the brain scan. The scan begins with an initial x-ray like picture for     about 10 minutes, after which the [18F]FECNT is injected and the actual PET scan starts. The     entire procedure takes about 6 hours, including 2 hours of continuous scanning sessions,     during which the subject is required to lie still. Subjects can relax out of the scanner     between scans. They are monitored throughout the procedure. Vital signs are measured and     electrocardiogram is taken once before and twice after injection of the tracer. At the end of     the scanning, additional blood and urine samples are collected. Subjects are asked to urinate     every 2 hours to lessen the radioactivity in the body.      Whole Body Imaging Study: Part 2      For this procedure, a catheter is placed in a vein for injecting the [18F]FECNT tracer. A     total of five scans are taken, each one spanning from head to upper thigh. During the course     of the scans, x-ray like pictures are obtained. The first scan takes about 100 minutes. Four     additional 1-hour scans are done every 100 minutes. The total time for the scans is about 6     hours, and the total time for the entire procedure is about 9 hours. About 2 tablespoons of     blood are drawn by needle stick at one time during the imaging. Subjects can leave the PET     scanner between scans. They are asked to urinate every 2 hours for 6 hours from the time of     tracer injection and to collect all the urine so that radioactivity can be measured.      Brain Imaging Study: Part 3      Part 3 of the study is the same as Part 1, except that two PET procedures are done on     separate days, the second within 4 weeks of the first. In addition, participants may also     under magnetic resonance imaging (MRI) scanning, a test that uses magnetic fields and radio     waves to obtain pictures of the brain.   "
171587|NCT00084448|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of     cancer by stopping blood flow to the tumor and may increase the effectiveness of paclitaxel     by making tumor cells more sensitive to the drug. Giving celecoxib together with paclitaxel     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel together with celecoxib     works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial     or primary peritoneal cancer.   "
171793|NCT00087451|"     A Phase I, open-label, non-randomized, sequential dose escalation cohort trial of the safety,     tolerability, and maximum tolerated dose (MTD) of AP23573 when administered intravenously as     a 30-minute infusion, once daily for five days, repeated every two weeks, to patients with     progressive or recurrent malignant glioma.   "
171530|NCT00083642|"     This study will determine how people who have had a stroke learn to perform a movement by     observation, as compared with people who have not had a stroke. Normally, a person learns a     new hand movement automatically by observing the movement performed by others. Improvement     with practice also relies on visual feedback. This observational training - i.e., the     repeated observation of a movement - is sufficient for normal individuals to learn a     movement. This study will examine brain activity related to motor learning in stroke patients     and in healthy control subjects to see whether stroke patients process visual-motor     information the same way normal subjects do.      Normal volunteers and stroke patients between 18 and 75 years of age may be eligible for this     study. Patients must have had paralysis on one side of the body due to a stroke that occurred     at least 3 months before entering the study. Candidates who have not had a recent health     screening will have a clinical and neurological examination.      Participants undergo the following procedures:        -  Brain magnetic resonance imaging (MRI), if one has not been done recently. This test          uses a strong magnetic field and radio waves to obtain images of body organs and          tissues. The subject lies on a table that can slide in and out of the cylindrical          scanner and wears earplugs to muffle loud noises caused by switching of magnetic fields.          Scanning time varies from 20 minutes to 3 hours, with most sessions lasting 45 to 90          minutes.        -  Task training. The subject practices the task to be performed during functional MRI (see          below). The subject makes finger tapping movements, then watches finger movements on a          video screen for several minutes, during which time the movie stops from time to time          without warning. When the movie stops, the subject must reproduce the last finger          movement that appeared on the screen. During this session, the electrical signals of the          subject's forearm muscles are recorded at the skin surface. This session lasts up to 3          hours.        -  Functional MRI. The subject undergoes MRI scanning while performing the same tasks done          in the training session. This session lasts about 3 hours.   "
171531|NCT00083668|"     The primary objective of the double-blind phase of this study is to evaluate the efficacy and     safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in     adult patients with schizophrenia   "
171532|NCT00083681|"     The purpose of this investigational trial is to find out how well patients respond and how     long their response lasts when treated with a four day chemotherapy regimen involving     dexamethasone, cytoxan, etoposide, and cisplatinum, or DCEP with or without thalidomide.     Another purpose is to find out what kind of side effects patients will experience.   "
171533|NCT00083694|"     The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients     with leukemia.   "
171534|NCT00083707|"     The purpose of this research is to study how helpful thalidomide is in controlling the     disease and to study any side effects from taking thalidomide.   "
171535|NCT00083720|"     This is a phase II, multicenter, open-label study of cetuximab in patients with epidermal     growth factor receptor (EGFR) negative, metastatic colorectal carcinoma who have progressed     after receiving at least one standard chemotherapeutic regimen that included a     fluoropyrimidine. Target enrollment is 80 evaluable patients.      Patients with EGFR-negative metastatic colorectal carcinoma who have progressed after     receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine,     will receive an initial dose of cetuximab, 400 mg/m2 , intravenously (i.v.) over 120 minutes,     followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes. Patients who     experience unacceptable toxicity or who have progressive disease (PD) will not receive     further cetuximab therapy.      Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on     cetuximab therapy. Patients with stable disease (SD), partial response (PR), or a complete     response (CR) may continue to receive weekly cetuximab therapy, unless they are dose-delayed     or discontinued because of toxicity. Patients who have a PR or CR must have a confirmatory     tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response.     To evaluate the objective response rate, a single-stage design will be used in this study.   "
171536|NCT00083733|"     This study will collect, analyze, and compare genes and proteins in normal breast tissue with     those in various tissues from women with breast cancer to look for changes that are unique to     breast cancer cells. Information about these differences may lead to more effective breast     cancer treatments with fewer side effects. The study has the following objectives:        -  To define the molecular (genetic and protein) profile of normal breast tissue from pre-          and post-menopausal women of different ages and who have had varying numbers of children          (or no children), and who are in different phases of the menstrual cycle        -  To define the molecular profile of primary breast tumors and tumors that have          metastasized (spread) beyond the primary site        -  To characterize breast cancer stem cells and establish cell lines from the pleural fluid          (fluid around the lungs) of women with metastatic breast cancer. (A cell line is a          collection of cells that are grown in the laboratory from an original tissue specimen.)      The following women may be eligible for this study:        -  Women who are undergoing cosmetic breast surgery that requires removal of some breast          tissue (e.g., breast reduction surgery)        -  Women 18 years of age or older who are undergoing a biopsy or other surgical procedure          to sample or remove a known or suspected primary or metastatic breast tumor        -  Women 18 years of age or older who are undergoing pleurocentesis, a procedure to remove          fluid from around the lung that is suspected or known to be caused by spread of breast          cancer      Participants undergo the required procedure (e.g., surgery, biopsy, or pleurocentesis) and     provide information that may include the following:        -  Age, race/ethnicity        -  Age at first menstrual period (menarche)        -  Age at first pregnancy and age when the first child was born        -  Age at menopause        -  Information about primary breast cancer        -  Family history of breast cancer        -  Information on previous breast biopsies, if any, and hormones taken (birth control pills          or hormone replacement therapy), if any        -  Copy of pathology report from procedure (surgery, biopsy, or pleurocentesis)   "
171537|NCT00083759|"     The purpose of this study is to determine the safety, tolerability and efficacy of     natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis (RA) receiving     concomitant treatment with methotrexate (MTX). It is thought that natalizumab may stop the     movement of certain white blood cells, known as lymphocytes, into joint tissue. These cells     are thought to cause damage in the joints leading to the symptoms of RA.   "
171538|NCT00083772|"     Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV)     filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of     patients admitted with acute diastolic heart failure.      Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in     Doppler diastolic filling parameters in patients with diastolic heart failure.   "
171539|NCT00083785|"     The purpose of this study is to determine whether the Litx™ system is safe and effective in     combination with chemotherapy in the treatment of liver metastasis arising from colorectal     cancer. Litx™ is a next-generation photodynamic therapy platform in which the drug,     talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based     light infusion device, inserted directly into the tumor through the skin prior to treatment.   "
171540|NCT00083798|"     To study the genetic basis of obstructive sleep apnea using a genealogical approach.   "
171541|NCT00083811|"     To investigate the role of genetics in cardiorespiratory fitness, obesity, and risk of     hypertension.   "
171542|NCT00083824|"     To clarify the effects of estrogen, with or without progestin, on high density lipoprotein     (HDL) in postmenopausal women.   "
171543|NCT00083837|"     To test whether specific genes affect lipoprotein and weight responses to vigorous exercise     in identical twins.   "
171544|NCT00083850|"     To evaluate the effects of genetic variants in all of the nine adrenergic receptor subtype     genes, alone or in combination, on cardiovascular reactivity and other quantitative     cardiovascular traits in a population of 1048 healthy young twins.   "
171551|NCT00083941|"     The purpose of this study is to test the safety of an investigational vaccine called TroVax     when given in conjunction with Interleukin-2 (IL-2) treatment. TroVax is the experimental     product in this trial and its value as a medicine has not yet been proven. Interleukin-2     (IL-2) is standard treatment for your cancer, which means that you could receive it even if     you choose not to participate in this study. TroVax is being studied as a possible treatment     for patients with cancer of the kidney.      TroVax belongs to a class of medicines called a vaccine. A vaccine helps the body's immune     system to recognize and kill foreign invading organisms effectively. It is believed that one     of the reasons why cancer can spread through the body is that the immune system cannot     recognize them as being different from normal tissues and therefore cannot kill the cancer     cells. A vaccine that alerts the immune system to the presence of cancer cells in the body     could lead to the immune system being able to target and kill those cancer cells effectively.     This trial is of a completely new way of trying to treat cancer in the future by the use of     vaccination injections. TroVax consists of a virus that has been changed so that it is no     longer infectious and carries a gene for a protein called 5T4. This protein is carried by     many kidney cancer calls. When the virus is injected, it makes the protein, and the body's     immune system is then able to recognize this protein and kill the cells that have it (i.e.     the cancer cells).      The purpose of this study is to assess the safety and tolerability of TroVax injections and     to understand whether TroVax could make such an immune response happen in patients with renal     cell cancer while receiving Interleukin-2 (IL-2). This study will also observe and monitor     any side effects experienced in patients who receive TroVax while being treated with IL-2.   "
171552|NCT00083954|"     The purpose of this study is to determine the efficacy of quetiapine compared to placebo in     the treatment for a major depressive episode in patients with bipolar disorder after     receiving treatment for up to 8 weeks.   "
171553|NCT00083967|"     The purpose of this study is to test if denufosol will remove the fluid build-up in the eye     so that the retina can be re-attached without invasive surgery.   "
171554|NCT00083980|"     The purpose of this study is to evaluate the safety and effectiveness of the herbal medicine     kava kava for the treatment of generalized anxiety disorder (GAD).   "
171555|NCT00083993|"     In this clinical research study, postmenopausal subjects with metastatic breast cancer will     be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and     letrozole in first-line hormonal treatment. The primary endpoint of this study is to     determine overall progression free survival.      Individual subjects will participate in the active treatment phase of the study until disease     progression or withdrawal of consent, provided that test article is being tolerated. All     subjects will be asked to participate in the long-term follow-up phase of the study, which     includes follow-up every 3 months until disease progression (for subjects who withdraw for     reasons other than documented progressive disease) or until any new cancer treatment is     received, and for survival. The estimated duration of study participation is 34 months.   "
171556|NCT00084019|"     Long-term side effects, the expense of medications, and the difficulty of taking medications     continuously for long periods of time are all problems with complicated anti-HIV drug     regimens. The purpose of this study is to determine whether two drugs, atazanavir (ATV) and     ritonavir (RTV), will control HIV infection when taken together without any other anti-HIV     drugs after 48 weeks of viral suppression.      Hypothesis: Simplified maintenance therapy with ATV and RTV alone after virologic suppression     does not markedly increase the risk of virologic failure.   "
171557|NCT00084032|"     People recently infected with HIV who are treated with anti-HIV medications may develop     strong immune system responses to HIV and may be able to control the virus without continuing     to take these medications. The purpose of this study is to see if giving anti-HIV medications     to people soon after they have been infected with HIV can help them control HIV. The study     will also see if the immune system can control the amount of HIV virus in the blood (viral     load) even after a person has stopped taking the medications. The study will evaluate three     different schedules of stopping and starting anti-HIV medications to see which schedule is     best able to boost a patient's immune system to control HIV viral load.      Hypothesis: Combination therapy started in primary HIV infection, in conjunction with     structured treatment interruptions, will result in greater control of viremia off treatment     than induction therapy alone.   "
171558|NCT00084045|"     Voluntary HIV counseling and testing (VCT) and anti-HIV drugs for pregnant women and their     newborns decrease rates of mother-to-child transmission (MTCT) of HIV. This study will     determine the acceptability of HIV counseling and rapid testing prior to delivery and will     compare the usefulness of VCT prior to birth versus after birth in preventing MTCT of HIV in     pregnant women in Cape Town, South Africa. This study will also determine the acceptability     and effectiveness of giving anti-HIV medications to prevent MTCT of HIV.   "
171559|NCT00084058|"     The purpose of this study is to determine the effect of increased doses of     lopinavir/ritonavir (LPV/r) and saquinavir (SQV) in HIV infected children who are failing     their current antiretroviral regimen   "
171560|NCT00084071|"     The purpose of this study is to determine whether tifacogin is effective and safe in the     treatment of patients with severe community-acquired pneumonia.   "
171561|NCT00084084|"     Primary Objective(s):        -  To assess the safety of Replagal at a dose of 0.2 mg/kg administered over 40 (+/-10)          minutes in children with Fabry disease        -  To assess the effect of Replagal on heart rate variability in patients 7 to 17 years of          age      Secondary Objective(s):        -  To determine the pharmacokinetics of Replagal at baseline and after the initiation of          enzyme replacement therapy (ERT)        -  To determine exploratory measurements of efficacy including renal function (ie,          estimated glomerular filtration rate [eGFR] and creatinine clearance), clinical outcomes          (in Cohorts 1 and 2), and sweating and left ventricular mass index (LVMI) (Cohort 1,          Phase 1 only)   "
171588|NCT00077857|"     This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to     that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced     or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients     were randomized to receive either 1250 mg/m^2 or 825 mg/m^2 orally twice a day (po bid) on     days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on     day 1 of each 3 week cycle. The anticipated time on study treatment was until disease     progression and the target sample size was 440 individuals.   "
171589|NCT00077870|"     This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and     subject-blinded study of the safety of escalating doses of ocrelizumab in combination with     MTX in subjects with moderate to severe RA   "
171590|NCT00077883|"     The purpose of this trial is to study the efficacy and safety of the combination of TLK286     with cisplatin as first-line therapy for patients with locally advanced or metastatic     non-small cell lung cancer.   "
171709|NCT00086229|"     The purpose of this study is to examine the way the dietary supplements glucosamine and     chondroitin are absorbed and distributed throughout the body.   "
171562|NCT00084097|"     This study will evaluate the safety and usefulness of omalizumab (anti-IgE, Xolair) in     reducing eosinophil counts and improving symptoms in patients with eosinophilic     gastroenteritis (EG). EG is a disorder of unknown cause in which eosinophils, a type of white     blood cell, are increased in the blood and gut tissue. Patients with EG have symptoms like     stomach pain, bloating, and vomiting. About 50 percent of EG patients have food or     environmental allergies, which may play a role in EG. Some patients with EG improve     significantly on diets avoiding foods to which they are allergic. Immunoglobulin E (IgE) is     an antibody that plays an important role in initiating allergic reactions. Omalizumab is a     monoclonal antibody directed against IgE. The Food and Drug Administration approved     omalizumab in 2003 for treating patients 12 years of age and older with allergic asthma.      Patients between 12 and 76 years of age with eosinophilic gastroenteritis who have a blood     eosinophil count of 500 or more and who have a food allergy or allergy to an inhaled allergen     may be eligible for this study. Candidates are screened with a medical history, physical     examination, and blood and urine tests.      Participants undergo the following procedures:        -  Leukapheresis. This procedure is done to collect quantities of white blood cells to          study the effects of omalizumab on eosinophils and other immune substances. Blood flows          from a needle placed in an arm vein through a catheter (plastic tube) into a machine          that separates the blood into its components by centrifugation (spinning). Some of the          white cells are removed and the rest of the blood (red cells, plasma and platelets) is          returned to the body through a needle in the other arm.        -  Skin testing. Participants are tested for allergies to specific substances. A small          amount of various allergens (substances that cause allergies) are placed on the          subject's arm. The skin is pricked at the sites of the allergens and the skin reaction          after several minutes is observed.        -  Upper and lower endoscopy. One or both of these procedures is done, depending on the          part of the gastrointestinal tract that is involved, to examine the tract. If both          procedures are done, they are performed at the same time. For the upper endoscopy, the          subject's throat is sprayed with a numbing medicine and a long, flexible tube is passed          through the esophagus, stomach and small intestine. For the lower endoscopy, the tube is          passed through the rectum into t...   "
171563|NCT00084110|"     The purpose of this study is to examine complementary and alternative medicine use among     older Mexican Americans and to determine how this use influences physical, functional, and     mental health.   "
171564|NCT00084123|"     The purpose of this study is to evaluate the effects of healing touch and relaxation therapy     on cervical cancer patients undergoing chemotherapy and radiation treatment.   "
171565|NCT00084136|"     This study compared 3 different three-drug combinations in HIV infected individuals starting     their first HIV treatment regimens. Participants were recruited from resource-limited areas     in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis     was each of the once daily combinations (PI based, or NNRTI based) would not have inferior     efficacy compared to the twice daily NNRTI based combination.   "
171566|NCT00084149|"     Cyclosporine A (CsA) is a common long-term treatment used to inhibit the immune response in     transplant patients who receive donor organs. CsA may also help people with HIV. The purpose     of this study is to determine the safety of and immune response to CsA when given with     abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/AZT) and lopinavir/ritonavir (LPV/r) to     HIV infected adults in the early stages of infection.      Study hypothesis: The combination of CsA and LPV/r given to acutely infected individuals will     result in lower levels of proviral DNA and latent infectious virus at 48 weeks compared to     acute infected individuals treated with LPV/r alone.   "
171567|NCT00084162|"     This study will examine how depression may influence the way the brain regulates heart     function. Some researchers believe that depression may be a risk factor for some forms of     heart disease.      Right-handed healthy volunteers and patients with major depressive disorder who are between     18 and 50 years of age may be eligible for this study. Female candidates must be     premenopausal. Patients must currently be experiencing a major depressive episode. All     candidates are screened with a medical history and physical examination, electrocardiogram,     and blood and urine tests. They are interviewed about their psychiatric and medical history,     current emotional state and sleep pattern, and family history of psychiatric disorders. They     complete symptoms ratings scales for depression, anxiety, and negative thinking; history of     alcohol and tobacco use; level of physical activity; socioeconomic status; overall level of     functioning; and, for depressed patients, their depression type. Women candidates have their     menstrual phase determined by the timing of their recent menstrual cycles and may undergo     testing to determine the time of their ovulation.      Participants undergo the following tests and procedures:        -  12-minute walk/run test - This test measures the subject's general level of          cardiorespiratory fitness. In a gymnasium in the NIH Clinical Center, the subject walks          or runs as far as he or she can in 12 minutes. Blood pressure is measured before and          after the exercise test, and heart rate is measured during exercise with a monitor worn          around the chest.        -  Magnetic resonance imaging (MRI) - A brain MRI scan is done to obtain pictures of the          brain anatomy. Electrocardiogram leads are placed on the subject's chest to measure the          electrical activity of the heart during the scanning session. The subject lies on a          narrow bed in the scanner, which is a narrow metal cylinder about 6 feet long. The          scanning session takes up to 90 minutes.        -  Positron emission tomography (PET) - PET scanning produces images of the brain's blood          flow. The subject is injected with a radiotracer (small amount of drug labeled with a          radioactive substance) that is detected by a special camera to trace blood flow. During          the scanning session, the subject lies still on a table. EKG leas are placed on the          subject's chest to measure the electrical activity of the heart during the scan. A mask          with holes for the eyes, ears, and mouth is placed over the subject's face to keep the          head f...   "
171568|NCT00084175|"     The purpose of this study is to evaluate a five-session Human Immunodeficiency Virus/Acquired     Immune Deficiency Disease (HIV/AIDS) group therapy designed specifically for heterosexual     men. This therapy is compared to standard HIV/AIDS education, which generally consists of a     single session of HIV education.   "
171569|NCT00084188|"     The purpose of this study is to look at a program for women in drug abuse treatment designed     to reduce Human Immunodeficiency Virus/Sexually Transmitted Disease (HIV/STD) risk behaviors     and reduce unprotected sexual risk behavior.   "
171570|NCT00084201|"     The purpose of study is to determine whether cranberry juice interacts with antibiotics used     to treat urinary tract infections (UTIs).   "
171571|NCT00084214|"     This study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and     paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma     patients.   "
171572|NCT00084227|"     The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is     non-inferior to atovaquone-proguanil for the treatment of symptomatic, uncomplicated malaria     due to P. falciparum.   "
171573|NCT00084240|"     The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily     for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus     chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.   "
171574|NCT00084253|"     The purpose of this study is to find out if 300 mg of ATV plus 100 mg of ritonavir (RTV)     works as well as 400 mg of ATV alone as part of a regimen with stavudine XR and lamivudine to     slow or stop the progression of HIV infection in patients who have never used anti-HIV drugs.   "
171575|NCT00084266|"     To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired     in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult     subjects. Subjects entered in to the study will have proven healthcare-associated     methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either     linezolid or vancomycin.   "
171577|NCT00084292|"     This multi-center collaborative study will establish a database of information about stroke     in infants and children.      Participating children have their medical and research records reviewed for information about     their stroke. The information is gathered and entered into a secure electronic database     called REDCap. All information is de-identified.      This study does not require any additional interventions but two outcome measures are     typically administered: the Paediatric Stroke Outcome Measure (PSOM) and the Recovery and     Recurrence Questionnaire (RRQ). The PSOM is used during clinic visits by the study     co-investigator; the RRQ is a parental questionnaire that can be completed during clinic     visits or by telephone interview for those parents who cannot attend the follow up     appointment. Both measures assess neurological function.      The IPSS also provides participating centers with the option to share de-identified patient     CT and MRI's in the IPSS Imaging Repository housed at The Hospital for Sick Children in     Toronto, Canada; incorporating a neuroimaging component would improve our understanding of     the processes underlying plasticity and recovery in childhood stroke.      Participating Investigators have the opportunity to access the larger dataset for use in     group publications but each center will retain ownership of their own data. These     contributing Investigators are recognized through authorship.      The activities of the network are creating the opportunity for manuscript writing, grant     development and collaboration on clinical challenges in paediatric stroke. Ultimately, this     data will allow physicians to better diagnose, treat, and prevent stroke in children.   "
171578|NCT00084305|"     The etiology of pulmonary fibrosis is unknown. Analyses of blood, genomic DNA, and specimens     procured by bronchoscopy, lung biopsy, lung transplantation, clinically-indicated     extra-pulmonary biopsies, or post-mortem examination from individuals with this disorder may     contribute to our understanding of the pathogenic mechanisms of pulmonary fibrosis. The     purpose of this protocol is to procure and analyze blood, genomic DNA, and specimens by     bronchoscopy, lung biopsy, lung transplantation, extra-pulmonary biopsies, or post-mortem     examination from subjects with pulmonary fibrosis. In addition, blood, genomic DNA,     clinically-indicated extra-pulmonary biopsies, as well as bronchoscopy and post-mortem     examination specimens may be procured and analyzed from relatives of subjects with hereditary     forms of pulmonary fibrosis; blood, genomic DNA, and bronchoscopy specimens may be procured     from healthy research volunteers.   "
171579|NCT00084318|"     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells     from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to     damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to     radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them     after surgery may kill any remaining tumor cells.      PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with     chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab     given together with chemoradiotherapy using docetaxel in treating patients with resected     stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and     neck.   "
171580|NCT00084344|"     RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased     risk of developing breast cancer. 4-hydroxytamoxifen gel (a substance made when tamoxifen     breaks down in the body) may be effective in reducing breast density by reducing estrogen     levels with fewer side effects than tamoxifen. This may improve quality of life and the     ability to detect breast cancer with screening mammography.      PURPOSE: Randomized screening study to determine the effect of 4-hydroxytamoxifen gel on     breast density, salivary sex steroids (hormones), and quality of life in premenopausal women.   "
171581|NCT00084370|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of celecoxib before prophylactic oophorectomy     may be an effective way to prevent the development of ovarian epithelial cancer.      PURPOSE: A controlled pilot trial to study the effectiveness of celecoxib in preventing     cancer in patients at high-risk for ovarian epithelial cancer who are undergoing prophylactic     oophorectomy.   "
171582|NCT00084383|"     RATIONALE: Vaccines made from gene-modified pancreatic cancer cells may make the body build     an immune response to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil,     work in different ways to stop tumor cells from dividing so they stop growing or die.     Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy     together with chemotherapy and radiation therapy after surgery may kill any remaining tumor     cells.      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with     adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II     adenocarcinoma (cancer) of the pancreas.   "
171583|NCT00084396|"     RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by reducing the production of estrogen. Giving letrozole     before surgery may shrink the tumor so that it can be removed.      PURPOSE: This phase II trial is studying how well neoadjuvant letrozole works in treating     postmenopausal women who are undergoing surgery for estrogen-receptor positive or     progesterone-receptor positive stage II, stage IIIA, or stage IIIB breast cancer.   "
171584|NCT00084409|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Iloprost may be effective in preventing lung cancer.      PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing     lung cancer in patients who are at high risk for this disease.   "
171585|NCT00084422|"     RATIONALE: CEP-701 may stop the growth of tumor cells by blocking the enzymes necessary for     their growth.      PURPOSE: This phase I trial is studying the side effects and best dose of CEP-701 in treating     young patients with recurrent or refractory high-risk neuroblastoma.   "
171586|NCT00084435|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells     more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any     remaining tumor cells.      PURPOSE: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin     and docetaxel works in treating patients with completely resected stage III or stage IV head     and neck cancer.   "
171591|NCT00077896|"     This pilot study will evaluate the effect of direct current (DC) electrical polarization of     the brain on language, memory, reaction time, and mood in six patients with frontotemporal     dementia (Pick's disease). There is no effective treatment available for cognitive impairment     in patients with this condition. DC polarization sends a very weak current between two sponge     pads placed on the head. In a previous study in healthy volunteers, DC polarization of the     left prefrontal area of the brain increased verbal fluency, memory and attention, and motor     reaction time in the study subjects.      Patients between 35 and 75 years of age with frontotemporal dementia who have been referred     to NINDS's Cognitive Neuroscience Section for an existing protocol will be offered     participation in this study. Candidates will be screened with a neurological examination to     confirm the diagnosis of frontotemporal dementia.      Participants receive 40 minutes of DC polarization or sham polarization in each of two     separate sessions. (No current is applied in the sham treatment). During the polarization,     the patient rests quietly. Sponge pads that have been soaked in water are put on the left     side of the head and above the right eye, and are held in place with elastic netting. Before     the polarization and after about 20 minutes of polarization, patients undergo the following     tests:        -  Language: Patients must say as many words beginning with certain letters as they can in          90 seconds.        -  Memory: Patients must remember a letter on a computer screen, and when the letter          appears again, press the same letter on the keyboard.        -  Reaction time: Patients place pegs on a pegboard.        -  Mood: Patients place a mark on a line ranking how they feel.   "
171592|NCT00077909|"     This study will examine the different types of proteins present in the lungs of patients with     pneumonia to explore the causes of different types of the disease. Pneumonia is a condition     that causes lung inflammation AND is often caused by an infection. It is usually diagnosed by     lung x-rays and listening to the chest with a stethoscope. This method can diagnose     pneumonia, but it does not provide information on the cause of the inflammation - information     that might be helpful in guiding treatment. This study will measure proteins in the lungs of     patients to see if certain proteins are associated with specific forms of pneumonia, and can     thus serve as biomarkers for disease.      Patients undergoing diagnostic bronchoscopy at the NIH Clinical Center may participate in     this study. Patients will undergo bronchoscopy and bronchoalveolar lavage as scheduled for     their medical care. For this procedure, the patient's mouth and throat are numbed with     lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is     advanced through the nose or mouth into the lung airways to examine the airways carefully.     Saline (salt water) is then injected through the bronchoscope into the air passage, acting as     a rinse. A sample of fluid is then withdrawn for microscopic examination. Researchers in the     current study will use some of the fluid obtained from the lavage to examine for protein     content.      In addition to the bronchoscopy and bronchoalveolar lavage, participants will have about 2     tablespoons of blood drawn to compare blood test results with the results of the lung     washings. Patients' medical records will be reviewed to obtain information on past medical     history, current medical treatment, vital signs, and results of x-ray tests.   "
171593|NCT00077922|"     This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating     chronic lymphocytic leukemia (CLL) in patients who have a protein called cluster of     differentiation 25 (CD25) on their cancer cells. LMB-2 is a recombinant immunotoxin. It is     made up of two parts: a genetically engineered monoclonal antibody that binds to cancer cells     with CD25 on their surface, and a toxin produced by bacteria that kills the cancer cells to     which it binds. LMB-2 has killed CD 25-containing cells in laboratory experiments and has     caused tumors in mice to shrink. Preliminary studies in humans have shown some effectiveness     in shrinking tumors in patients with various types of lymph and blood cancers.      Patients 18 years of age and older with CLL who have CD25 receptor proteins on their cancer     cells and whose disease has progressed within 2 years of treatment with fludarabine may be     eligible for this study. Candidates are screened with a medical history and physical     examination, blood and urine tests, electrocardiogram (EKG), echocardiogram, chest x-ray,     computed tomography (CT) scans of the chest, abdomen and pelvis, and a bone marrow biopsy.      Participants receive up to six cycles of LMB-2 therapy. Each 28-day cycle consists of     30-minute infusions of LMB-2 on cycle days 1, 3, and 5. The drug is infused through an     intravenous (IV) catheter (plastic tube placed in a vein) or a central venous line-an IV tube     placed in a large vein in the neck or chest that leads to the heart. Patients are admitted to     the National Institutes of Health (NIH) Clinical Center for the first treatment cycle. If the     infusion is well tolerated, subsequent cycles may be given on an outpatient basis. In     addition to drug therapy, patients undergo the following procedures:        -  Blood draws: Blood is drawn before, during, and after each LMB-2 infusion to measure          blood levels of the drug, evaluate its effects on the cancer cells, and monitor side          effects. Blood tests are also done before and during each cycle to determine how the          immune system is interacting with the drug.        -  Disease evaluations: Patients undergo a physical examination, blood tests, chest x-ray,          and EKG before each treatment cycle and at follow-up visits. With the patient's          permission, CT scans, echocardiogram, and bone marrow biopsies may be repeated before          some treatment cycles if these tests prove useful in evaluating the disease response to          LMB-2.      Patients may receive up to six cycles of LMB-2 as long as their cancer does not worsen and     they do not develop serious side effects. At the end of the treatment cycles, patients will     have blood tests done weekly by their local physician, and the results will be sent to the     NCI study investigators.   "
171594|NCT00077935|"     The purpose of this study is to evaluate the safety of Civamide Cream 0.075% as a Treatment     in Subjects with Osteoarthritis (OA) of the Knee(s).   "
171595|NCT00077948|"     Beta-blocker medications have been shown to improve heart function and prolong the lives of     patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty     taking beta-blocker medications due to troublesome side effects, such as low blood pressure     and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words,     they have difficulty tolerating beta-blocker medications. The purpose of this study is to     determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication.   "
171596|NCT00077961|"     The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used     in combination with rituximab for patients with relapsing or refractory, low-grade or     follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary     objective of phase I, while the primary objective of phase II will be to determine overall     response.   "
171597|NCT00077974|"     To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal     cell carcinoma   "
171598|NCT00077987|"     Assessment of safety and efficacy of SU11248 in patients with metastatic colorectal cancer     who have failed selected previous treatments.   "
171599|NCT00078000|"     Assessment of safety and efficacy of SU11248 in patients with metastatic breast cancer who     have failed selected other therapies.   "
171794|NCT00087464|"     Short-term therapy may reduce the amount of HIV in the blood of adults recently infected with     HIV. The purpose of this study is to see whether it is better for people to take a short     course of anti-HIV drugs when they are first infected or if it is better to wait until the     HIV infection causes health problems before taking anti-HIV drugs.   "
171601|NCT00078026|"     Osteoporosis affects millions of postmenopausal women in the USA. The current approved     treatments are all drugs that prevent bone loss and possibly result in small gains in bone     mass. Another possible treatment consists of drugs that increase bone formation. There are     currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid     hormone (hPTH). Neither of these two drugs has been approved by the FDA. APOMINE has shown     significant bone formation in animal studies. In this study we plan to test whether APOMINE     is able to stimulate new bone formation in women with osteoporosis or low bone mass.   "
171602|NCT00078039|"     The primary objective of the double blind phase of this study is to evaluate the efficacy and     safety of 3 fixed dosages of paliperidone ER (6, 9, and 12 mg/day) compared with placebo in     adult patients with schizophrenia.   "
171603|NCT00078052|"     To investigate genetic markers of coronary heart disease in type 2 diabetes.   "
171604|NCT00078065|"     This trial is a phase II, randomized study of patients with multiple myeloma. All patients     will receive Xcellerated T Cells, with or without prior fludarabine therapy.      15 patients in each study arm will be followed for 6 months.   "
171605|NCT00078078|"     This study will evaluate patients with methylmalonic acidemia (MMA) to learn more about the     genetic causes of the various types of this inherited metabolic disorder and the medical     complications associated with it. People with MMA may have problems with learning and     development and kidney malfunctioning. They can become seriously ill, sometimes with little     warning. There is no cure for any MMA, but special diets and vitamin therapies are used for     treatment.      Patients between 2 and 70 years of age with MMA may be eligible for this study. Participants     are admitted to the NIH Clinical Center for 4-5 days each year for 5-10 years for the     following tests and procedures:        -  Medical history, physical examination, eye examination        -  Consultations from dentists and specialists in the nervous system, digestive tract,          endocrine, and kidney, as needed.        -  24-hour urine collection to examine for methylmalonic acid, other acids, sugar, and          proteins for measuring kidney function.        -  Blood test to assess liver and thyroid function, blood counts and blood chemistries,          methylmalonic acid levels, and for genetic tests and basic research studies.        -  Blood test to measure growth hormone production. For this test, a very small amount of          blood is collected overnight (every 20-30 minutes from 8:00 PM to 8:00 AM) through an          intravenous catheter (plastic tube placed in a vein). The total amount of blood drawn is          approximately 1 tablespoon. Patients who have stopped growing or whose weight does not          permit collection of 1 tablespoon of blood do not undergo this procedure.        -  Frequent blood pressure measurements, including overnight monitoring        -  Skin biopsy for cell culture (cells to grow in the laboratory for future testing). For          this procedure, an area of skin is numbed with an anesthetic such as lidocaine. A 4-mm          diameter circular area is then removed using a sharp punch and scissors. The wound is          dressed and usually heals within a week.        -  Photographs of the face and body (wearing underwear) to help track growth and          appearance.        -  Ultrasound of the kidneys        -  Hand x-ray to determine bone age        -  Dual energy x-ray absorptionometry (DEXA) scan to assess bone density. For the DEXA          scan, the patient lies still on a table while the spine and hip are scanned using a          small amount of radiation.      Any patient who becomes seriously ill during the evaluation may be cared for at the NIH or     transferred to another hospital if it is deemed advisable.   "
171606|NCT00078091|"     This study will evaluate patients with a rare inherited condition called Bardet-Biedl     syndrome . The purpose of the study is to learn more about the genetics and clinical     characteristics of this disorder. Patients may have the following problems: polydactyly     (extra fingers and toes); retinal dystrophy (changes in the retina that may lead to vision     problems, including blindness); obesity and diabetes (overweight and high blood sugar due to     failure of body organs to respond to insulin); cognitive dysfunction (difficulties with     learning and understanding); hypogenitalism (decreased functioning of the ovaries in women     and the testes in men); kidney anomalies (changes in the structure or function of the     kidneys); heart disease; and hepatic fibrosis (liver disease).      Patients with Bardet-Biedl syndrome may be eligible for this study. First-degree relatives     will also be enrolled for certain tests and procedures. Candidates are screened with a review     of their medical records, laboratory tests, and x-rays.      Patients in this study undergo the following tests and procedures:        -  Medical and family history and physical examination, including body measurements.        -  Blood tests to evaluation kidney, liver, heart, and hormonal function, and for genetic          studies and other research purposes.        -  Dual emission x-ray absorptiometry (DEXA) scan to measure the amount of total body fat.          For this test, the subject lies on a table for scanning with low-dose X-rays.        -  Computed tomography (in adults) of the abdomen to measure abdominal fat. CT uses a small          amount of radiation to obtain images of internal body structures.        -  Magnetic resonance imaging (in children) of the abdomen to measure abdominal fat. MRI          uses a magnetic field and radio waves to obtain images of internal body structures.        -  Oral glucose tolerance tests to measure blood glucose and insulin levels. For this test,          the patient drinks a glucose (sugar) solution. Blood samples are drawn through an IV          catheter before the test begins and at 1, 2, and 3 hours after drinking the solution.        -  Complete eye examination to look for retinal changes and to assess vision, and, if          medically needed, an examination of the ear, nose, and throat to check for hearing and          breathing abnormalities.        -  Tests of learning ability in patients over 5 years of age. For younger patients, a          parent is asked about the child's development.        -  Ultrasound study of the ovaries and uterus in females and of the testes in males.        -  Photographs of the face, hands, feet, body, and genitalia, if the patient agrees.        -  Meeting with investigators and a genetic counselor for review of test findings when the          studies are completed.      Relatives of patients have a complete medical and family history and physical examination.     Blood is drawn for assessment of kidney, liver, heart, and hormonal function and for genetic     study and other research purposes. Relatives over 5 years of age may have tests of learning     ability and cognition. For younger patients, a parent is asked about the child's development.     Relatives meet with investigators and a genetic counselor for review of test findings when     the studies are completed.   "
171607|NCT00078104|"     This study will evaluate how well different medications work to relieve pain following third     molar (wisdom tooth) extraction. Scientists believe that hormone-like substances called     prostanoids contribute to pain following oral surgery. Prostanoids are produced by     cyclooxygenase (COX) enzymes. This study will examine how different medicines inhibit the COX     enzymes and reduce the amount of prostanoids, and thus the amount of inflammation and pain.     The study will also look at genetic factors involved in the production of prostanoids and the     response to pain medication. (Only the bottom two wisdom teeth are extracted for this study.     Patients whose top wisdom teeth also need to be removed will have those teeth extracted, also     free of charge, at least 2 weeks after the first surgery.)      Healthy normal volunteers between 16 and 35 years of age who are in general good health and     who require third molar extraction may be eligible for this study. Candidates are screened     with a medical history and oral examination, including dental x-rays as needed to confirm the     need for third molar removal.      On the morning of surgery, patients have blood drawn to obtain DNA for genetic study. Women     of childbearing age have a urine pregnancy test. One hour before surgery, patients receive a     dose of rofecoxib (Vioxx® (Registered Trademark)), acetaminophen (Tylenol® (Registered     Trademark)), or placebo (a pill with no active ingredient). A half-hour before surgery, they     receive either a standard painkiller called keterolac (Toradol® (Registered Trademark))) or     placebo through an arm vein. All patients also receive the sedative midazolam (Versed®     (Registered Trademark)), also through an arm vein, to induce drowsiness and a local     anesthetic (lidocaine) to numb the mouth. After the mouth is numbed, but before the wisdom     teeth are extracted, a biopsy (removal of a small piece of tissue) is conducted in the area     of the cheek next to the wisdom tooth.      After the surgery, a small piece of tubing is placed into both extraction sites. Every 20     minutes for the next 3 hours, inflammatory fluid is collected from the tubing to measure     chemicals that are believed to cause pain and swelling. Patients complete questionnaires     every 20 minutes to rate their pain. Those who still have pain an hour after surgery may     request and receive a rescue drug called tramadol (Ultram® (Registered Trademark)) for pain     relief. Patients remain in the clinic from 3 to 6 hours to monitor the effects of the study     drugs as the anesthetic wears off.      After surgery a second biopsy is done to measure any changes in the chemicals being produced     in response to the surgery. For this biopsy, patients are assigned to one of two groups - one     group has the second biopsy within 3 hours of surgery, before taking the rescue drug, and the     other group returns to the clinic the next morning for a biopsy 24 hours after surgery.     Patients in the second group leave the clinic after surgery with two pain medications     (tramadol and the study drug) and forms to record pain ratings at home. They are permitted to     take only the pain medications provided and only at certain times.      At the end of their participation in the study, all patients are given the pain medication     flurbiprofen (Ocufen® (Registered Trademark)) to take at home.   "
171608|NCT00078117|"     The purpose of this protocol is to to compare the clinical utility of two dosage tapering     regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.   "
171609|NCT00078130|"     The purpose of this study is to compare two 3-month treatments for adolescents/young adults     who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and     treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of     psychosocial therapy.   "
171610|NCT00078143|"     The purpose of this study is to compare Motivational Enhancement Therapy (MET) with standard     drug abuse treatment among pregnant women.   "
171611|NCT00078156|"     The purpose of this study is to compare the effectiveness of adding Seeking Safety to     standard substance abuse treatment to adding a control condition: Women's Health Education to     standard substance abuse treatment.   "
171612|NCT00078169|"     The purpose of this study is to compare a three-session Spanish version of Motivational     Enhancement Therapy (MET) to standard treatment to see how well MET engages and retains     Spanish-speaking clients in outpatient substance abuse treatment.   "
171613|NCT00084461|"     Phase II trial to study the effectiveness of romidepsin in treating patients who have locally     advanced or metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as romidepsin,     work in different ways to stop tumor cells from dividing so they stop growing or die.   "
171614|NCT00084487|"     Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor     cells from dividing so they stop growing or die. This phase II trial is studying how well     rebeccamycin analog works as second-line therapy in treating patients with limited-stage or     extensive-stage small cell lung cancer that has relapsed after previous first-line     chemotherapy.   "
171705|NCT00086177|"     This research study is being conducted at over 12 pregnancy research centers in the US. The     study will compare an investigational treatment with a placebo (a treatment without     medication). Neither the investigators nor the patients in the trial will know which     treatment has been assigned. All study medications will be given vaginally once a day.     Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy     week 36.   "
171615|NCT00084513|"     RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Imatinib     mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their     growth and by stopping blood flow to the tumor. Giving trastuzumab together with imatinib     mesylate may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate     when given together with trastuzumab in treating patients with recurrent or metastatic     HER2/neu-expressing (producing) cancer.   "
171616|NCT00084526|"     RATIONALE: New imaging procedures such as CT-on-rails™ may improve the ability to pinpoint     the location of the tumor and decrease radiation therapy damage to healthy tissue.      PURPOSE: This phase I/II trial is studying how well computed tomography (CT) scans using     CT-on-rails™ work in pinpointing the location of the tumor in patients with prostate cancer.   "
171617|NCT00084539|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hypofractionated     (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy     (radiation directed at the tumor more precisely than in standard radiation therapy) with     incorporated boost (an increase in the amount of radiation given during treatment) may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well adjuvant hypofractionated     intensity-modulated radiation therapy with incorporated boost works in treating patients with     early-stage breast cancer.   "
171618|NCT00084552|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.     Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in     standard radiation therapy) may reduce damage to healthy tissue near the tumor. It is not yet     known whether reducing the dose of radiation to erectile tissue will help prevent erectile     dysfunction.      PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy     alone to see how well it works compared to intensity-modulated radiation therapy with reduced     doses to erectile tissue in treating patients with stage II prostate cancer.   "
171619|NCT00084565|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work     in different ways to stop tumor cells from dividing so they stop growing or die. Giving more     than one chemotherapy drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel, topotecan, and     estramustine together works in treating patients with metastatic hormone therapy-refractory     prostate cancer.   "
171620|NCT00084578|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth and by stopping blood flow to the tumor. Rosiglitazone may help tumor cells     develop into normal bladder cells.      PURPOSE: This randomized clinical trial is studying how well giving celecoxib together with     rosiglitazone works in treating patients who are undergoing cystoscopic surveillance     (screening) for early-stage noninvasive (carcinoma in situ) carcinoma (cancer) of the bladder     or radical cystectomy for muscle-invasive carcinoma (cancer has spread into the muscle layer     of bladder tissue) of the bladder.   "
171621|NCT00084591|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.     Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in     standard radiation therapy) with incorporated boost (an increase in the amount of radiation     given during treatment) may cause less damage to normal tissue. Drugs used in chemotherapy,     such as capecitabine, work in different ways to stop tumor cells from dividing so they stop     growing or die. Giving radiation therapy together with chemotherapy before surgery may shrink     the tumor so it can be removed.      PURPOSE: This phase I trial is studying the side effects and best dose of neoadjuvant     intensity-modulated radiation therapy with incorporated boost when given together with     capecitabine in treating patients with locally advanced rectal cancer.   "
171622|NCT00084604|"     This phase II trial is studying how well giving irinotecan and cisplatin together with     bevacizumab works in treating patients with unresectable or metastatic gastric (stomach) or     gastroesophageal junction adenocarcinoma (cancer). Drugs used in chemotherapy, such as     irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they     stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and     either kill them or deliver tumor-killing substances to them without harming normal cells.     Giving chemotherapy together with a monoclonal antibody may kill more tumor cells.   "
171623|NCT00084617|"     Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Giving more     than one chemotherapy drug may kill more tumor cells. This phase II trial is studying how     well giving oxaliplatin together with irinotecan and capecitabine works in treating patients     with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction     adenocarcinoma (cancer).   "
171624|NCT00084630|"     This phase II trial is studying how well imatinib mesylate works in treating patients with     locally recurrent or metastatic dermatofibrosarcoma protuberans (DFSP) or transformed     fibrosarcomatous DFSP (a type of soft tissue sarcoma). Imatinib mesylate may stop the growth     of tumor cells by blocking the enzymes necessary for their growth   "
171625|NCT00084643|"     This phase I trial is studying the side effects and best dose of capecitabine when given     together with GTI-2040 and oxaliplatin in treating patients with locally advanced or     metastatic colorectal cancer or other solid tumors. Drugs used in chemotherapy, such as     oxaliplatin and capecitabine, work in different ways to stop tumor cells from dividing so     they stop growing or die. GTI-2040 may increase the effectiveness of chemotherapy by making     tumor cells more sensitive to the drugs. Giving GTI-2040 together with oxaliplatin and     capecitabine may kill more tumor cells   "
171626|NCT00084656|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. Vaccines may make the body     build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51     may cause a stronger immune response and kill more tumor cells. Giving monoclonal antibody     therapy together with vaccine therapy may be an effective treatment for stage III or stage IV     melanoma.      PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together     with vaccine therapy works in treating patients with resected stage III or stage IV melanoma.   "
179996|NCT00192439|"     - Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash     aspirates in children at high risk for severe LRI disease (hospitalized at <2 years of age).   "
171627|NCT00084669|"     RATIONALE: Venlafaxine may be effective in relieving hot flashes caused by hormone therapy.     Giving venlafaxine with zolpidem (a sleeping pill) may improve sleep and quality of life in     women who are receiving hormone therapy for treatment or prevention of breast cancer.      PURPOSE: This randomized clinical trial is studying giving venlafaxine together with zolpidem     to see how well it works compared to venlafaxine alone in relieving hot flashes and     associated sleep disorders in women who are receiving hormone therapy to treat or prevent     breast cancer.   "
171628|NCT00084682|"     This phase II trial is studying how well FR901228 works in treating patients with     unresectable recurrent or metastatic squamous cell carcinoma (cancer) of the head and neck.     Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from     dividing so they stop growing or die.   "
171629|NCT00084695|"     RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were     destroyed by chemotherapy or radiation therapy.      PURPOSE: This phase II trial is studying how well umbilical cord blood works as a source of     stem cells in treating patients with types of cancer as well as other diseases.   "
171630|NCT00084708|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Calcitriol may help tumor cells develop into normal cells. Dexamethasone may     increase the effectiveness and decrease the side effects of gefitinib and calcitriol.      PURPOSE: This phase I trial is studying the side effects and best dose of calcitriol when     given together with gefitinib or when given together with gefitinib and dexamethasone in     treating patients with advanced solid tumors.   "
171631|NCT00084721|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop     tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor     cells by blocking the enzymes necessary for their growth. Giving irinotecan with celecoxib     may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when     given with celecoxib in treating patients with unresectable or metastatic colorectal cancer.   "
171632|NCT00084734|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, capecitabine, and cisplatin, work     in different ways to stop tumor cells from dividing so they stop growing or die. Giving more     than one chemotherapy drug may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel,     capecitabine, and cisplatin in treating patients with metastatic or unresectable solid     tumors.   "
171633|NCT00084747|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary     for their growth. Giving bortezomib as maintenance therapy after autologous stem cell     transplantation may kill more cancer cells and prolong remission.      PURPOSE: This phase I/II trial is studying the side effects and best dose of adjuvant     bortezomib as maintenance therapy and to see how well it works in treating patients who have     undergone stem cell transplantation for intermediate or advanced multiple myeloma.   "
171634|NCT00084773|"     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy such as fluorouracil work in different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Giving cetuximab with fluorouracil and radiation therapy may kill more tumor cells.   "
171635|NCT00084786|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Drugs used in chemotherapy such as docetaxel work in different ways to stop     tumor cells from dividing so they stop growing or die. Giving gefitinib with docetaxel may     kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib when     given with docetaxel in treating patients with advanced solid tumors.   "
171636|NCT00084799|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells.      PURPOSE: This phase I trial is studying the side effects of monoclonal antibody therapy in     treating patients with progressive small cell lung cancer.   "
171637|NCT00084812|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop     tumor cells from dividing so they stop growing or die. Safingol may stop the growth of tumor     cells by blocking the enzymes necessary for their growth and by stopping blood flow to the     tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of safingol when given     with cisplatin in treating patients with locally advanced or metastatic solid tumors.   "
171638|NCT00084825|"     RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor     cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of     tumor cells by blocking the enzymes necessary for their growth. Giving docetaxel with     imatinib mesylate may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel with imatinib mesylate     works in treating patients with androgen-independent prostate cancer and bone metastases that     progressed while receiving docetaxel and a placebo on clinical trial MDA-ID-030008.   "
171639|NCT00085202|"     Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in     different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with     chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to     replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is     not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell     transplant is more effective in treating medulloblastoma, supratentorial primitive     neuroectodermal tumor, or atypical teratoid rhabdoid tumor.      This phase III trial is studying two different regimens of radiation therapy when given     together with chemotherapy and autologous stem cell transplant to see how well they work in     treating patients with newly diagnosed medulloblastoma, supratentorial primitive     neuroectodermal tumor, or atypical teratoid rhabdoid tumor.      PRIMARY OBJECTIVE:        -  To assess the relationship between ERBB2 protein expression in tumors and          progression-free survival probability for patients with medulloblastoma.        -  To estimate the frequency of mutations associated with SHH and WNT tumors (as defined by          gene expression profiling) via targeted sequencing performed in an independent cohort of          WNT and SHH tumors (also defined by gene expression profiling).   "
171640|NCT00085228|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. Oblimersen may increase the     effectiveness of docetaxel by making tumor cells more sensitive to the drug.      PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with     oblimersen works compared to docetaxel alone in treating patients with hormone-refractory     adenocarcinoma (cancer) of the prostate.   "
171641|NCT00085254|"     Cilengitide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to damage tumor cells. Giving cilengitide together with temozolomide and     radiation therapy may kill more tumor cells. This randomized phase I/II trial is studying the     side effects and best dose of cilengitide when given together with temozolomide and radiation     therapy and to compare how well they work in treating patients with newly diagnosed     glioblastoma multiforme   "
171642|NCT00085280|"     This clinical trial is studying how well erlotinib works in treating patients with stage     IIIB, stage IV, or recurrent non-small cell lung cancer. Erlotinib may stop the growth of     tumor cells by blocking the enzymes necessary for their growth.   "
171643|NCT00085293|"     This phase II trial is studying how well decitabine works in treating patients with     metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding     to radioactive iodine. Iodine I 131 (radioactive iodine) kills thyroid cancer cells.     Metastatic thyroid cancer cells can lose the ability to be treated with radioactive iodine.     Decitabine may help thyroid cancer cells regain the ability to respond to treatment with     radioactive iodine.   "
171644|NCT00085306|"     RATIONALE: Interferon beta may interfere with the growth of tumor cells.      PURPOSE: This phase II trial is studying how well interferon beta works in treating patients     with metastatic cutaneous (skin) melanoma or ocular (eye) melanoma.   "
171645|NCT00085332|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with     recurrent or persistent endometrial carcinoma (cancer).   "
171646|NCT00085345|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic     acid, work in different ways to stop cancer cells from dividing so they stop growing or die.     Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making     them more sensitive to the drugs.      PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic     trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple     myeloma.   "
171647|NCT00085358|"     This phase I trial is studying the side effects and best dose of intraperitoneal infusions of     carboplatin when given together with intravenous infusions of either docetaxel or paclitaxel     followed by intraperitoneal paclitaxel in treating patients with stage II, stage III, or     stage IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma (cancer).     Drugs used in chemotherapy, such as carboplatin, docetaxel, and paclitaxel, work in different     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one     drug and giving them in different ways may kill more tumor cells   "
171648|NCT00085371|"     This phase II trial is studying how well triapine works as first-line or second-line therapy     in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the     pancreas. Drugs used in chemotherapy, such as triapine, work in different ways to stop tumor     cells from dividing so they stop growing or die.   "
171649|NCT00085384|"     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells.      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of     PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian     epithelial, peritoneal, or fallopian tube cancer that is resistant to platinum-based     chemotherapy.   "
171650|NCT00085397|"     RATIONALE: Vaccines made from a patient's dendritic cells may make the body build an immune     response to kill tumor cells. It is not yet known whether combining vaccine therapy with     either gp100 antigen or the patient's tumor cells will cause a stronger immune response and     kill more tumor cells.      PURPOSE: This randomized phase II trial is studying vaccine therapy and gp100 antigen to see     how well they work compared to vaccine therapy and patient's tumor cells in treating patients     with stage III or stage IV melanoma.   "
171651|NCT00085410|"     This phase II trial is studying how well bortezomib works as first-line systemic therapy in     treating patients with unresectable locally advanced or metastatic adenocarcinoma (cancer) of     the bile duct or gallbladder. Bortezomib may stop the growth of tumor cells by blocking the     enzymes necessary for their growth.   "
171652|NCT00085423|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2     may stimulate a person's white blood cells to kill tumor cells and may help a person's immune     system recover from the side effects of chemotherapy.      PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine     together with high-dose interleukin-2 works in treating patients with metastatic melanoma.   "
171653|NCT00085436|"     RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body     build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's     lymphocytes to kill kidney cancer cells. Interferon alfa may interfere with the growth of     cancer cells. Combining vaccine therapy with interleukin-2 and interferon alfa may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with     interleukin-2 and interferon alfa works in treating patients with metastatic renal cell     carcinoma (kidney cancer).   "
171680|NCT00085839|"     The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy     of erlotinib and standard chemotherapy in patients with advanced, previously untreated     nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG)     performance status (PS) of 2. The study will also evaluate the safety of single-agent     erlotinib in this patient population.   "
171681|NCT00085852|"     The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume     Reduction (BLVR) System is safe in patients with advanced emphysema.   "
171654|NCT00085449|"     RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.     It also stops the patient's immune system from rejecting the donor's stem cells when they do     not exactly match the patient's blood. The donated stem cells may replace the patient's     immune system and help destroy any remaining cancer cells (graft-versus-tumor effect).     Sometimes the transplanted cells from a donor can also make an immune response against the     body's normal cells. Giving cyclosporine and mycophenolate mofetil before transplant may stop     this from happening.      PURPOSE: This phase I/II trial is studying the side effects of alemtuzumab, fludarabine, and     melphalan with or without cyclosporine, mycophenolate mofetil, and total-body irradiation     before donor peripheral blood stem cell transplant and to see how well they work in treating     patients with relapsed or refractory hematologic cancer.   "
171655|NCT00085462|"     RATIONALE: Inserting a gene that has been created in the laboratory into a person's white     blood cells may make the body build an immune response to kill tumor cells. Interleukin-2 may     stimulate a person's white blood cells to kill tumor cells. Vaccines may make the body build     an immune response to kill tumor cells. Combining gene-modified white blood cell infusions     with interleukin-2 and vaccine therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying how well giving gene-modified white blood cells when     given together with interleukin-2 and vaccine therapy works in treating patients with     metastatic melanoma.   "
171656|NCT00085475|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes     necessary for their growth.      PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating     patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell     fibroblastoma.   "
171657|NCT00085488|"     RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body     build an immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with stage III or stage IV melanoma.   "
171658|NCT00085501|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies     such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing     substances to them without harming normal cells. Combining more than one chemotherapy drug     with a monoclonal antibody may kill more tumor cells. It is not yet known whether cetuximab     is more effective when given at the same time as chemotherapy or following chemotherapy.      PURPOSE: This randomized phase II trial is studying how well giving cetuximab at the same     time as combination chemotherapy works compared to giving cetuximab after combination     chemotherapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.   "
171659|NCT00085527|"     RATIONALE: FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for     their growth.      PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with     relapsed or refractory advanced ovarian epithelial cancer.   "
171660|NCT00085540|"     This phase I/II trial is studying the side effects and best dose of FR901228 and to see how     well it works in treating patients with recurrent high-grade gliomas. FR901228 may stop the     growth of tumor cells by blocking the enzymes necessary for their growth   "
171661|NCT00085553|"     This phase I trial studies the side effects and best dose of tipifarnib and erlotinib     hydrochloride in treating patients with solid tumors that have spread to other places in the     body. Tipifarnib and erlotinib hydrochloride may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
171662|NCT00085566|"     RATIONALE: Everolimus may stop the growth of tumor cells by stopping blood flow to the tumor.     Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their     growth. Combining everolimus with gefitinib may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when     given together with gefitinib and to see how well they work in treating patients with     progressive glioblastoma multiforme or (progressive metastatic prostate cancer closed to     accrual 10/19/06).   "
171663|NCT00085579|"     RATIONALE: Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill     melanoma cells.      PURPOSE: This phase II trial is studying how well giving interleukin-2 together with     sargramostim works in treating patients with stage III or stage IV melanoma that was     previously treated with chemotherapy.   "
171664|NCT00085631|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop     tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy     x-rays to damage tumor cells. Hyperthermia therapy kills tumor cells by heating them to     several degrees above body temperature. It is not yet known whether chemotherapy and     radiation therapy are more effective with or without hyperthermia therapy in treating     cervical cancer.      PURPOSE: This randomized phase III trial compared the safety and efficacy of cisplatin and     radiation therapy, together with hyperthermia therapy versus cisplatin and radiation therapy     alone in the treatment of locally advanced cervical cancer.   "
171665|NCT00085644|"     The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given     every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an     inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal     anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1     disease-modifying antirheumatic drug (DMARD).   "
171666|NCT00085657|"     This study will examine whether brain stimulation using transcranial direct current     stimulation (tDCS) in stroke patients undergoing rehabilitation therapy can help patients     recover strength and motor function more than rehabilitation therapy alone. For tDCS, two     small metal disks (electrodes) attached to wires are placed on small cotton pads and taped to     the subject's head, one on the forehead above the eye and the other on the top of the head.     The electrodes deliver a brief electrical current that stimulates the cortex, the part of the     brain responsible for motor function.      Adult patients who have weakness on one side of their body as a result of a stroke occurred     within the last 15 days may be eligible for this study. NIH is not directly recruiting     patients for this study. Patients will be selected through the National Rehabilitation     Hospital (NRH) Research Center personnel in Washington, DC, from patients under treatment at     that facilitiy. Candidates are screened with a physical and neurologic examination, a review     of tests done on admission to NRH, and a magnetic resonance imaging (MRI) scan, if one has     not been done since the stroke. MRI uses a strong magnetic field and radio waves to obtain     images of the brain. The MRI scanner is a metal cylinder surrounded by a strong magnetic     field. During the MRI, the patient lies on a table that can slide in and out of the cylinder.     Scanning time for this study takes about 30 to 45 minutes.      Participants are randomly assigned to receive tDCS or placebo stimulation, along with     rehabilitation therapy, for 2 to 3 weeks, depending on the patient's length of stay at the     NRH. For the placebo stimulation, electrodes are placed on the patient's scalp as with tDCS,     but no current is delivered. Before and after each rehabilitation session with electrodes,     patients undergo Jebsen Taylor motor testing, in which they are asked to lift small objects,     turn cards, use a spoon, stack checkers, and lift cans as fast as they can.      On the day of discharge, patients have physical and neurological examinations and the motor     function tests described below. The motor tests are repeated, along with standard care and a     review of their health status, during outpatient follow-up visits scheduled at 3, and 12     months. The motor tests are:        -  Wolf motor function test - Patients are asked to raise a forearm on a table, on a box,          to reach across a table, push a sandbag, place a hand on the table, pull a weight, lift          a can, pick up a pencil, pick up a paper clip, stack checkers, flip cards, use a key,          fold a towel, and pick up a basket.        -  Barthel index - Patients are timed for the speed with which they perform certain tasks,          such as feeding, grooming, or moving a wheelchair.        -  Abilhand questionnaire - Patients answer questions about how they perform routine daily          activities.        -  GOT test of tactile discrimination - Patients describe objects they feel with their          hand.        -  Ashworth spasticity scale - A medical staff person moves the patient's arm back and          forth to see how stiff it is.   "
171667|NCT00085670|"     This study will examine whether cytokine gene polymorphisms affect the progression or     response to therapy of bone marrow failure disorders. Cytokine genes instruct cells to     produce proteins called cytokines that influence immune system response. As with many genes,     the cytokine genes differ slightly from person to person. These differences are called gene     polymorphisms. Different patients with the same bone marrow failure disease often progress     and respond to treatment differently. This study will look at the possible role of cytokine     gene polymorphisms in these differences.      Patients between 2 and 80 years old who have participated in an NHLBI Hematology Branch     treatment protocol for acquired aplastic anemia, myelodysplastic syndrome, or pure red cell     aplasia are recruited to participate in this study. Blood collected and stored at the time of     screening for the treatment protocol will be tested for cytokine gene polymorphisms. No     additional tests, procedures, or treatments are involved in this study.   "
171668|NCT00085683|"     This study will explore whether the human herpes virus-6 is associated with epileptic     seizures. The virus may be involved in brain scarring, called mesial temporal sclerosis,     which is seen in some epilepsy patients. The virus is also thought possibly to interfere with     neurotransmitters - chemicals that brain cells use to communicate with each other. This study     will measure levels of two of these chemicals, GABA and glutamate, which are believed to play     a role in the development of seizures.      Patients with epilepsy, with or without mesial temporal sclerosis, and healthy control     subjects 18 years of age and older may be eligible for this study. Control subjects may not     be taking any medication on a regular basis. Epilepsy patients may take only phenytoin,     carbamazepine, oxcarbazepine, lamotrigine, or levetiracetam. Candidates are screened with a     physical examination and blood tests.      Participants have blood drawn and undergo magnetic resonance imaging (MRI) and lumbar     puncture (spinal tap).      Blood Draw      Up to four teaspoons of blood are drawn through a needle in the arm for this study.      MRI      MRI uses a magnetic field and radio waves to produce pictures of the brain. The scanner is a     metal cylinder surrounded by a strong magnetic field. During the scan, the subject lies on a     bed that slides into the cylinder, wearing earplugs to muffle loud noises the machine makes     when the magnetic fields are switched. The scan takes about 90 to 120 minutes, during which     time the subject can communicate with the technician.      Lumbar Puncture      For this test the subject sits upright or lies on his or her side with knees curled at the     chest. A local anesthetic is injected at the lower back, and a needle is inserted in the     space between the bones where the cerebrospinal fluid circulates below the spinal cord. A     small amount of fluid is collected through the needle. Collection of the fluid usually takes     from 5 to 20 minutes.   "
171669|NCT00085696|"     The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given     in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell     Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the     time it takes your lymphoma to get worse.   "
171670|NCT00085709|"     RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different     ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies,     such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Combining chemotherapy with     gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction     therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab     ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective     than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia.      PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy     and monoclonal antibody therapy to see how well they work in treating patients with     previously untreated de novo acute myeloid leukemia.   "
171671|NCT00085722|"     The purpose of this study is to determine whether prolotherapy (PrT), a therapy based on     injection of a sugar solution in and around the knee, can decrease pain and disability from     knee osteoarthritis (OA).   "
171672|NCT00085735|"     This randomized phase III trial is studying how well standard-dose radiation therapy works     compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard     volume boost radiation therapy works compared to smaller volume boost radiation therapy when     given together with chemotherapy in treating young patients who have undergone surgery for     newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to     damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine,     and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop     growing or die. Giving radiation therapy with chemotherapy after surgery may kill any     remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more     effective than reduced-dose radiation therapy when given together with chemotherapy after     surgery in treating young patients with medulloblastoma.   "
171673|NCT00085748|"     The primary objective of the study is to evaluate the safety and tolerability of flexible     dosages of paliperidone ER as compared with placebo in patients with schizophrenia who are 65     years of age or older. The primary objective of the open-label extension is the long-term     assessment of safety and tolerability of paliperidone ER in patients diagnosed with     schizophrenia.   "
171674|NCT00085761|"     The purpose of the study is to determine if an investigational drug, NGX-4010     (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful     HIV-associated neuropathy.   "
171675|NCT00085774|"     This study was designed to examine the effectiveness of two bronchodilator inhalers in     patients who have exercise-induced asthma.   "
171676|NCT00085787|"     This is a Phase 1 study during which patients with advanced solid tumors will receive     investigational study drug ARRY-142886.      This study has 2 parts. In the first part, patients will receive increasing doses of study     drug in order to achieve the highest dose of study drug possible that will not cause     unacceptable side effects. Approximately 25 patients from the US will be enrolled in Part 1     (Completed).      In the second part of the study, patients will receive the best dose of study drug,     determined from the first part of the study, and will be followed to see what side effects     the study drug causes and what effectiveness the study drug has, if any, in treating the     cancer. Approximately 35 patients from the US will be enrolled in Part 2 (Completed).   "
171677|NCT00085800|"     To investigate the relationship between dietary fiber and cardiovascular inflammatory     markers.   "
171678|NCT00085813|"     This study was designed to determine how effective and safe Ispinesib is in treating locally     advanced or metastatic Non-small Cell Lung cancer in patients who have received a     platinum-based chemotherapy and whose disease continues to progress. Treatment involves a     1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue     treatment as long as they are benefiting from the treatment. Blood samples will be taken at     specific times over 24 hr period to measure the amount of drug in your body at specific times     after the drug is given. Blood samples will also be taken for routine lab tests such as     complete blood counts and clinical chemistries. Physical exams will be performed before each     treatment.   "
171679|NCT00085826|"     Taxotere has been approved by the FDA and is considered a standard treatment for patients     with lung cancer who have failed prior platinum-containing regimens. The main purpose of this     research study is to determine if Aptosyn, when given in combination with Taxotere, will     result in prolonged survival when compared to Taxotere alone.      This study will also help determine tumor response rates, and the safety profile of Aptosyn     in combination with Taxotere.      This study has been completed and a publication is pending.   "
171795|NCT00087477|"     This pilot study will assess the safety and efficacy of Pivanex alone in patients with     malignant melanoma who have relapsed after treatment with chemotherapy or Interleukin-2     (IL-2). Pivanex is an investigational agent.   "
171682|NCT00085865|"     This study will compare serotonin transporter proteins in people with alcoholism and healthy     volunteers to examine how these proteins may be related to the inability of people with     alcoholism to appropriately regulate their alcohol consumption. Serotonin transporters     regulate levels of the brain chemical serotonin. Problems in this regulation have been     implicated in alcoholism.      Healthy normal volunteers and people who suffer from alcoholism who are between 18 and 75     years of age may be eligible for this study. Candidates are screened with a medical history     and physical examination, psychiatric diagnostic interview, blood and urine tests, an     electrocardiogram, urine toxicology screen, and written psychological evaluations.      Participants undergo positron emission tomography (PET) and magnetic resonance imaging (MRI)     scanning to measure serotonin transporter levels in the brain.      PET uses small amounts of a radioactive chemical called a tracer that labels the serotonin     transporters in the brain. The tracer used in this study is [11C]DASB. For the procedure, the     subject lies on the scanner bed. A special mask is fitted to the head and attached to the bed     to help keep the subject's head still during the scan so the images will be clear. A brief     scan is done just before the radioactive tracer is injected. This scan provides measures of     the brain that will help in the precise calculation of information from subsequent scans.     After the tracer is injected through a catheter (plastic tube) placed in the arm, pictures     are taken for about 2 hours.      MRI uses a magnetic field and radio waves to produce pictures of brain structure. The subject     lies on a bed that slides into the tube-like scanner, wearing earplugs to muffle loud noises     the machine makes when the magnetic fields are switched. The scan takes about an hour, during     which time the subject can communicate with the technician.   "
171683|NCT00085878|"     This is a phase I, open-label, dose-escalation study of SB-485232. Subjects will receive     SB-485232 administered as subcutaneous injections daily for 14 days. Dose escalation     (enrollment into the next cohort) cannot occur until all three subjects have completed the     previous cohort; 5 doses will be tested. An additional dosing regimen has been added to     evaluate higher doses given twice weekly for 7 weeks. Therefore, the full evaluation period     for each patient will extend out to approximately eleven weeks after the first day of     SB-485232 dosing.   "
171684|NCT00085891|"     The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine     compared to placebo in patients with schizophrenia after receiving treatment for up to 6     weeks.   "
171685|NCT00085904|"     SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28     days in adult subjects with advanced solid tumors or lymphomas. Subjects may receive up to 6     cycles of treatment unless progressive disease or unacceptable toxicity is noted. Three dose     levels of drug will be investigated. Safety evaluations, including blood sampling for various     laboratory tests, will be conducted. Additional blood samples will also be taken to measure     the amount of drug in the body at specific times.   "
171686|NCT00085917|"     This study will evaluate the safety and effectiveness of combination therapy with     peginterferon alpha-2a and ribavirin for treating hepatitis C virus (HCV) infection in     HIV-infected patients. Peginterferon alpha with ribavirin is the therapy of choice for people     with HCV alone. Peginterferon alpha-2a is a compound that results from attaching a     polyethylene glycol molecule to interferon alpha-2a. This compound stays in the blood longer     than unmodified interferon alpha-2a, causing a higher blood concentration and thus     maintaining greater activity against the hepatitis C virus.      HIV-infected patients 18 years of age and older with chronic hepatitis C infection and a     viral load greater than 2000 copies/mL may be eligible for this 2-1/2 year study. Candidates     are screened with a medical history and physical examination, blood and urine tests, eye     examination, chest x-ray, electrocardiogram (EKG), liver ultrasound, and pregnancy test in     women who are able to become pregnant. If a recent liver biopsy is not available, this test     is done to determine the type and severity of liver disease. The patient is given a sedative     before the procedure. Then, the skin in the area over the biopsy site is numbed with a local     anesthetic and a needle is inserted rapidly into and out of the liver to obtain a small     tissue sample. The patient remains in the hospital overnight for monitoring.      Participants begin treatment with injections under the skin of peginterferon alpha-2a and     ribavirin pills by mouth on study day 0. Peginterferon is given either once or twice a week     for 4 weeks and then once a week for 44 weeks. Ribavirin is given daily. In addition,     patients continue to take all other medications prescribed by their doctor. Clinic visits are     scheduled for the following procedures:        -  Days 1, 3, 4, 7, 10 and weeks 2, 3, and 4 - Blood tests for safety measures and to          measure blood levels of HIV and HCV.        -  Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 - Blood and urine tests to determine the          side effects of treatment and its effect on the HCV infection. In addition, eye          examinations are done every 3 months, and pregnancy and thyroid function tests are done          several times during the treatment period.        -  Week 48 or end of treatment - Treatment stops after 48 weeks. At this time, or earlier          for those who do not complete the 48 weeks, patients return to the clinic for a chest          x-ray, EKG, blood tests, and abdominal ultrasound. Patients are hospitalized for a          repeat liver biopsy.        -  Weeks 52, 56, 64 and 72 - Blood and urine tests to determine the side effects of          treatment and its effect on the HCV infection, and a urine pregnancy test in women.   "
171687|NCT00085930|"     Patients have high-risk neuroblastoma, a form of cancer typically found in children. The     patients previously participated in a gene transfer research study using special immune     cells. More information about that study follows.      The body has different ways of fighting infection and disease. No one way seems perfect for     fighting cancers. This research study combines two different ways of fighting disease,     antibodies and T cells, hoping that they will work together. Antibodies are types of proteins     that protect the body from bacterial and other infections. T cells, also called cytotoxic T     lymphocytes or CTLs, are special infection-fighting blood cells that can kill some tumor     cells. Both antibodies and T cells have been used to treat patients with cancers and while     they have shown promise, they have not been strong enough to cure most patients.      The antibody used in this study is called 14g2a. It first came from mice that have developed     immunity to human neuroblastoma. This antibody sticks to neuroblastoma cells because of a     substance on the outside of these cells called GD2. 14g2a and other antibodies that bind to     GD2 have been used to treat people with neuroblastoma. For this study 14g2a has been changed     so that instead of floating free in the blood, it is now joined to T cells. When an antibody     is joined to a T cell in this way it is called a chimeric receptor.      T lymphocytes or CTLs can kill tumor cells but there normally are not enough of them to kill     all tumor cells. Some researchers have taken T cells from a person's blood, grown more of     them in the laboratory and then given them back to the patient. Sometimes an antibody or     chimeric receptor is attached to these T cells to help them bind to tumor cells. These     chimeric receptor-T cells seem to kill some of the tumor, but they don't last very long in     the body and so the tumor eventually comes back. We have found that T cells that are also     trained to recognize the virus that causes infectious mononucleosis, Epstein Barr Virus     (EBV), can stay in the blood stream for many years. By joining the 14g2a antibody to the CTLs     that recognize EBV, we believe we will make a cell that can last a long time in the body     (because they are EBV-specific) and recognize and kill neuroblastoma cells (because an     antibody that can recognize these cells has been placed on their surface).      Patients received treatment with the immune cells described above. They may want to receive     an additional dose of these cells. This is being offered as an option because their     neuroblastoma has returned and they have enough cells remaining to provide the patients with     an additional dose. These 14g2a antibody CTLs are an investigational product not approved by     the Food and Drug Administration.   "
171688|NCT00085943|"     This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day     or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose     combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus     levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and     tolerability of these compounds over the 48 week study period in patients naive to anti-HIV     therapy.   "
171689|NCT00085956|"     The purposes of this study are to determine:        -  The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in          postmenopausal women.        -  The effects of arzoxifene on the uterus (womb) in postmenopausal women.        -  The effects of arzoxifene on blood tests that measure changes in bone rebuilding in          postmenopausal women with low bone density.        -  The effects of arzoxifene on blood lipids (fats) and other blood markers of heart          disease risk.        -  The safety of arzoxifene and any side effects that might be associated with its use.   "
171690|NCT00085969|"     The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of     exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.   "
171691|NCT00085982|"     Leptin is a hormone produced by the fat cells that researchers have shown to play a role in     controlling appetite. Certain people with severe insulin resistance have little or no leptin.      The purpose of this study is to investigate people whose leptin levels have been found to be     lower than 85 percent of the general population. Researchers will determine whether insulin     levels in these participants improve when they are treated with genetically engineered     leptin.      Study participants must be age 8 years or older and must have severe insulin resistance     syndrome and leptin deficiency. During an initial 7-day visit to the Clinical Center,     researchers will evaluate participants' metabolic parameters, such as insulin responsiveness,     lipid levels, appetite, and hormone levels. After taking these tests, participants will     self-inject doses of leptin once or twice a day and will be monitored for treatment outcomes     as well as side effects via follow-up visits. These inpatient follow-up visits will involve     both blood tests and imaging studies at the Clinical Center at 4, 8, and 12 months after the     initial visit, and every 6 months thereafter.   "
171692|NCT00085995|"     This study will evaluate: 1) whether computed tomography (CT) scanning is better than regular     x-rays for measuring changes in the stiffness, or fusion, of the spine in patients with     ankylosing spondylitis; and 2) if CT can be used to determine how fast extra bone forms in     the spine of these patients. Better ways to measure spinal fusion are needed to be able to     evaluate the effectiveness of medicines in slowing or stopping its progression. CT uses     x-rays to provide detailed pictures of the inside of the body and are valuable for detecting     spinal abnormalities because of the precision with which it can show these structures. For     the procedure, the patient lies on a table that moves into a large, donut-shaped scanner that     can move around the body to take pictures at different angles, which are viewed on a computer     monitor.      Patients 18 years of age and older with ankylosing spondylitis who are not currently taking     or planning to receive treatment with anti-TNF alpha medications (etanercept, infliximab,     adalimumab) for 1 year may be eligible for this study. Participants have eight clinic visits,     scheduled at study entry and at 4, 8, 12, 16, 20, 24, and 48 months, at the NIH Clinical     Center for the following procedures:        -  Clinical assessment (all visits) - includes medical history and physical examination,          measurement of spine flexibility with a tape measure and protractor, symptoms          questionnaire        -  Blood tests for measures of inflammation, including red blood cell sedimentation rate          and C-reactive protein level (all visits)        -  Urine pregnancy test in women of child-bearing age (visits 1, 4, 7, 8)        -  X-rays of the pelvis, low back, and neck (visits 1, 4, 7)        -  X-ray of the low back (visit 8)        -  CT scan of the low back (visits 1, 4, 7)        -  Magnetic resonance imaging (MRI) of the low back (visits 1, 4) - MRI combines a powerful          magnet with an advanced computer system and radio waves to produce accurate, detailed          pictures of organs and tissues. The patient lies on a table in a narrow cylinder          containing a magnetic field, wearing earplugs to muffle loud noises that occur with          electrical switching of the magnetic fields. He or she can speak with a staff member via          an intercom system at all times during the procedure. During the scan, a contrast dye          (gadolinium) is injected into the bloodstream through a catheter (plastic tube inserted          in a vein) to brighten the images.      In addition, participants will complete a symptoms questionnaire by mail every 4 months for 2     years between visits 7 and 8.   "
171693|NCT00086021|"     The purpose of this study is to determine whether acupuncture can reduce pain in long-term     headache sufferers.   "
171694|NCT00086034|"     The primary purpose of this study is to find out if motexafin gadolinium may be an effective     treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side     effects of motexafin gadolinium will be evaluated.   "
171695|NCT00086047|"     Juvenile fibromyalgia is a chronic pain condition that can cause considerable suffering and     difficulty in an adolescent's day-to-day activities. The purpose of this study is to     determine whether coping skills training, when combined with usual medical care, can reduce     pain and disability in adolescents with fibromyalgia.      Study hypotheses: 1) Adolescents who receive coping skills training combined with their usual     medical care will show significantly greater reductions in functional disability, pain, and     depressive symptoms at the end of the acute treatment phase than adolescents who receive     fibromyalgia education with their usual medical care. 2) Adolescents who receive coping     skills training with their usual medical care will show significantly lower levels of     functional disability, pain, and depressive symptoms at the end of a six-month maintenance     phase than adolescents who receive fibromyalgia education with their usual medical care.   "
171696|NCT00086060|"     Pain management techniques may influence how the brain processes pain and may help patients     with fibromyalgia (FM), a chronic pain condition. This study will train patients with FM to     use pain management techniques. Investigators will use brain scanning (functional magnetic     resonance imaging, or fMRI) technology to identify changes in how a patient's brain processes     pain over time. This study is primarily interested in examining cortical response to     different behavioral interventions.   "
171697|NCT00086073|"     The purpose of this trial is to study genetic and other risk factors that may be important in     the development of Parkinson's disease.   "
171698|NCT00086086|"     The purpose of this study is to evaluate whether weight-based or fixed starting doses result     in comparable hemoglobin increases and treatment effects in patients with heart failure and     anemia.   "
171699|NCT00086099|"     The primary objectives of this study are:        1. To evaluate whether the addition of amifostine will allow for the safe administration of          idarubicin at a dose of 21 mg/m² in combination with standard-dose ara-C in older          patients with newly diagnosed, previously untreated acute myeloid leukemia (AML); and        2. To estimate the complete remission rate of induction therapy with amifostine, idarubicin          (21 mg/m²), plus ara-C or induction therapy with idarubicin (12 mg/m²) plus ara-C in          this patient population.   "
171700|NCT00086112|"     The purpose of this trial is to determine the effectiveness of risperidone as an adjunctive     treatment in patients with GAD who demonstrate a less-than-optimal response to their current     anxiolytic treatment.   "
171701|NCT00086125|"     The purpose of this phase II study is to assess the efficacy of AP23573 in patients with     specified relapsed or refractory hematological malignancies.   "
171702|NCT00086138|"     The purpose of this study is to learn whether treating individuals with Alzheimer's disease     and depression with the anti-depressant medication sertraline (Zoloft) is helpful to people     with Alzheimer's disease and to their families and caregivers.   "
171703|NCT00086151|"     To develop a clinical prediction rule to identify patients with acute pulmonary embolism who     are at very low risk for short-term adverse outcomes.   "
171704|NCT00086164|"     The purpose of this study is to determine the effect of recipient vein pretreatment of     edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in     polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months     after enrollment.   "
171796|NCT00087490|"     To determine if linezolid is superior to vancomycin in the treatment of complicated skin and     soft tissue infections due to MRSA in adult subjects   "
171710|NCT00086242|"     RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being     and quality of life of patients who have cervical cancer. Changes in quality of life may be     related to changes in immune function and neuroendocrine function.      PURPOSE: This randomized phase I trial is studying how well telephone counseling works     compared to standard care in reducing stress in patients who have completed treatment for     stage I, stage II, or stage III cervical cancer.   "
171711|NCT00086255|"     The purpose of this study is to assess tiagabine for the treatment of cocaine dependence.   "
171712|NCT00086268|"     This study will evaluate the effects of an investigational drug in combination with     chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will     measure the effects of this combination on progression of lung cancer, cancer response to     treatments, and development of cancer-related bone lesions.   "
171713|NCT00086281|"     To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the     morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and     outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea     syndrome (OSAS).   "
171714|NCT00086294|"     This study will evaluate the effects of an experimental drug called ACP-103 on Parkinson's     disease symptoms and on dyskinesias (involuntary movements) that develop as a result of     long-term levodopa treatment. ACP-103 changes the spread of certain brain signals that are     affected in patients with Parkinson's disease.      Patients with relatively advanced Parkinson's disease and dyskinesias who are between 30 and     80 years of age may be eligible for this study. Candidates are screened with a complete     medical history and physical examination, neurological evaluation, blood and urine tests, and     electrocardiogram (ECG). A brain magnetic resonance imaging (MRI) scan, CT scan, and chest     x-ray may be done if medically indicated.      Patients enrolled in the study will, if possible, stop taking all antiparkinsonian     medications for one month (2 months for Selegiline) before the study begins and throughout     its duration. Exceptions are Sinemet (levodopa/carbidopa), Mirapex (pramipexole) and Requip     (ropinirole).      Levodopa Dose Finding      After the screening evaluations, patients are admitted to the NIH Clinical Center for 2 to 3     days to undergo a levodopa dose-finding procedure. For this test, patients stop taking     Sinemet and instead have levodopa infused through a vein. During the infusion, the drug dose     is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side     effects occur, or 3) the maximum study dose is reached. Side effects are monitored closely     during the infusions, and parkinsonian symptoms are evaluated frequently during and after the     infusions. The infusions usually begin early in the morning and continue until evening. Once     the infusion is finished, patients resume taking their regular oral Sinemet dose. The     infusions are repeated once a week during 1-day inpatient evaluations.      Treatment      Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill     with no active ingredient) once a week for 10 weeks or vice versa (placebo followed by     ACP-103). Patients are admitted to the Clinical Center for each dose. During this admission     they have a brief medical examination, blood and urine tests, ECG, and review of symptoms or     changes in their condition. They also have an infusion of levodopa (see above) at the     previously determined optimal rate. Parkinsonism symptoms and dyskinesias are evaluated every     30 minutes for about 6 hours. At the end of the infusions and ratings, patients are     discharged home with their regular Parkinson's medications until the following visit.      Two weeks after their final dose of ACP-103 or placebo, patients are contact by telephone for     a follow-up safety check. At that time, the investigator may ask the patient to return to the     clinic for closer evaluation.   "
171715|NCT00086307|"     This study compares the effectiveness of the combination of antidepressants: Lexapro and     Pramipexole, with the effectiveness of each antidepressant alone.      Purpose: Patients between 18 and 65 years of age with Major Depressive Disorder without     psychotic features may be eligible for this 9-week study. Candidates must currently be in a     major depressive episode of at least 4 weeks' duration, have failed to respond to treatment     with an SSRI (Prozac, Zoloft, Paxil, Luvox, Celexa), and not have failed to respond to more     than four antidepressants for the current episode. Candidates are screened with a physical     examination, psychiatric evaluation, blood tests, review of vital signs, height and weight     measurements, electrocardiogram (ECG), urine test for illegal drugs, and pregnancy test for     women.      Participants are tapered off antidepressants or other medications prohibited during the study     and remain drug-free for 1 week before starting treatment. They are then randomly assigned to     take pramipexole and escitalopram, pramipexole alone, or escitalopram alone for 6 weeks.     During the study, participants come to the clinic eight times for health assessments and     symptoms assessments, which include a check of vital signs and rating scales for depression     and anxiety, adverse events, and sexual functioning. Blood and urine samples are collected     periodically to monitor health, detect pregnancy in women, and detect illicit drug use.      At the end of the 6-week treatment period, participants have a physical examination, ECG,     blood test, and check of vital signs. Short-term anti-depressant treatment is offered, and     plans are made for long-term treatment.      Atendemos pacientes de habla hispana.   "
171716|NCT00086320|"     The purpose of this study is to determine the efficacy (effectiveness) and safety of     paliperidone ER compared with placebo in the prevention of recurrence of symptoms of     schizophrenia.   "
171717|NCT00086333|"     This is an open-label, randomized phase II trial of a monoclonal antibody (mAb) drug     immunoconjugate, SGN-15, administered weekly in combination with weekly docetaxel. The     primary objective of the study is to determine the optimal interval between SGN-15 and     docetaxel using FDG-PET imaging as a surrogate marker of response. In addition, clinical     response rate, duration of response, and survival data will be collected.   "
171718|NCT00086346|"     The purpose of this study is to evaluate the sirolimus conversion regimen as compared with     the calcineurin inhibitor continuation regimen with regards to renal function in stable liver     transplant subjects.   "
171719|NCT00086359|"     Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the     risk of passing HIV to their infants. This study will compare how well two different     combinations of anti-HIV medications control HIV in pregnancy, and whether these combinations     of drugs are effective in preventing HIV from being transmitted from a pregnant woman to her     baby. The two combinations are abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) and     zidovudine/lamivudine (ZDV/3TC) plus lopinavir/ritonavir (LPV/RTV).   "
171720|NCT00086372|"     This is a long-term follow-up study of people who are identified during acute or recent HIV     infection and are being followed at clinical research sites associated with the Acute HIV     Infection and Early Disease Research Program (AIEDRP).   "
171721|NCT00086385|"     The purpose of this study was to examine pharmacological and psychological interventions for     smokers over 50.   "
171722|NCT00086398|"     The purpose of this study is to evaluate the efficacy of Dual Focus Schema Therapy in     comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy     enhancements to the orientation/early treatment process of Therapeutic Community (TC)     residents.   "
171844|NCT00081562|"     Ankylosing spondylitis (AS) is a chronic inflammatory disease that affects the joints between     the vertebrae of the spine and the joints between the spine and the pelvis. The purpose of     this study is to collect information and blood samples from patients with AS and their     relatives for use in genetic studies.   "
171723|NCT00086411|"     The purpose of this study was to compare two different types of Food and Drug Administration     (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in     conjunction with two levels of counseling. It was hypothesized that the higher level of     counseling would have the highest rates of treatment completion and highest rates of     abstinence.   "
171724|NCT00086424|"     To explore the role of insulin growth factor in cardiovascular disease in older men and     women.   "
171725|NCT00086437|"     To study the effect of genes on lipid-lowering drug treatment in hypertriglyceridemia.   "
171726|NCT00086450|"     The purpose of this study is to compare 5-year mortality rates in diabetic individuals with     multivessel coronary artery disease (CAD) who undergo either coronary artery bypass grafting     (CABG) surgery or percutaneous coronary stenting.   "
171727|NCT00086463|"     The purpose of this study is to determine the safety and efficacy of Iloprost in subjects     that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).   "
171728|NCT00086476|"     Congenital bleeding disorders characterized by abnormal platelet granules include Gray     Platelet syndrome (GPS; defective alpha-granules), Hermansky-Pudlak syndrome (HPS; defective     delta-granules), and combined alpha delta-storage pool deficiency (alpha delta-SPD). Other     diseases associated with variable defects in platelet gamma-granules include Chediak-Higashi,     Griscelli, Wiskott-Aldrich, and Thrombocytopenia Absent Radius syndromes. These disorders are     models for the study of organelle formation in megakaryocytes and platelets. Characteristics     of megakaryocytopoiesis in these disorders have not been investigated because megakaryocytes     could not be cultured from patients in sufficient quantities for experimental purposes.     Recent advances have made it possible to culture megakaryocytes using serum-free media     supplemented with recombinant human thrombopoietin (TPO). Such cultured human megakaryocytes,     amplified from bone marrow-derived CD34+ stem cells, synthesize and store organellar proteins     and produce functional platelets. In this protocol, we plan to obtain bone marrow aspirates     from 40 children and adults (ages 2 to 80 years) with GPS, HPS, and related disorders.     Patients admitted to the NIH Clinical Center on specific disease-related protocols will be     enrolled in this protocol during their routine 3-5 day visits. We will culture megakaryocytes     from CD34+ stem cells isolated from bone marrow aspirates. Studies of cultured megakaryocytes     will include evaluation of granule membrane and soluble proteins using fluorescent antibodies     and immunoelectron microscopy and comparison of RNA and protein expression patterns between     normal and patient cells. Precautions will be taken to prevent the primary risk of the bone     marrow aspiration, i.e., prolonged bleeding at the aspiration site. Standard diagnostic     studies on the bone marrow sample may reveal information that may directly benefit patients.     However, the broader benefit of this study is the acquisition of a better understanding of     the characteristics of functional platelet disorders and the process of intracellular vesicle     formation.   "
171729|NCT00086489|"     The purpose of this study is to assess the efficacy, safety, and tolerability of monoclonal     antibody therapy using 2 regimens for the treatment of advanced melanoma   "
171730|NCT00086502|"     The purpose of this study is to determine the safety and efficacy of an investigational drug     in patients with type 2 diabetes mellitus.   "
171731|NCT00086515|"     The purpose of this study is to determine the safety and efficacy of an investigational drug     in patients with type 2 diabetes mellitus.   "
171732|NCT00086528|"     The primary objective of this study is as follows:        -  To evaluate the safety and tolerability of XL647 administered orally as a single dose          and as repeat doses in subjects with solid tumors.      The secondary objectives of this study are as follows:        -  To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose          and as repeat doses in subjects with solid tumors,        -  To estimate renal elimination of XL647 administered orally as a single dose in subjects          with solid tumors.      The exploratory objective of this study is as follows:        -  To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral          blood cells.      In addition, subjects may be eligible to enter a Treatment Extension Period. The following     information will be obtained from this part of the study:        -  Long-term safety and tolerability of XL647 after repeat administration,        -  Tumor response after repeat administration of XL647.   "
171733|NCT00086541|"     This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of     two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily     for 48 weeks and no treatment in patients chronically infected with hepatitis C who are     nonresponders to previous pegylated interferon alfa plus ribavirin therapy.      Patients are randomized 1:1:1 to receive Interferon Alfacon-1 (9 or 15 µg) + Ribavirin (both     administered daily) or no treatment for up to 48 weeks.      The protocol and informed consent form that will be used must be approved by the     Investigator’s Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the     study is initiated.   "
171734|NCT00086554|"     This study will collect tissue specimens to be used for research on inflammatory bowel     disease. The tissues will be used to explore why people get inflammatory bowel disease and to     try to develop new treatments based on the study results. Tissue from patients with IBD will     be compared with that from patients who do not have the disease      Patients who undergo bowel surgery for inflammatory bowel disease (IBD) or another bowel     disorder may be eligible for this study. Patients with IBD must be at least 4 years of age;     those with another disorder must be 18 years of age or older.      Participants undergo bowel surgery for their disease. Some of the intestinal tissue removed     during the surgery that is not needed for medical care, such as for pathological examination,     is provided to researchers for study under this protocol. In addition, patients with IBD     provide a blood sample for genetic testing. Several genetic variations, or mutations, may     increase the risk of developing IBD; blood samples from patients may help identify these     variations.   "
171747|NCT00086736|"     RATIONALE: Drugs used in chemotherapy, such as eflornithine, work in different ways to stop     tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of     prostate cancer cells. Drugs used in hormone therapy, such as bicalutamide, may fight     prostate cancer by stopping the adrenal glands from producing androgens. Combining     eflornithine with bicalutamide may kill more tumor cells.      PURPOSE: Randomized phase II trial to compare the effectiveness of neoadjuvant eflornithine     and bicalutamide with that of eflornithine alone, bicalutamide alone, and no neoadjuvant     therapy in treating patients who are undergoing brachytherapy or radical prostatectomy for     localized prostate cancer.   "
171748|NCT00086749|"     RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased     risk of developing breast cancer. Tamoxifen may be effective in reducing breast density by     decreasing estrogen levels.      PURPOSE: This phase I trial is studying how well tamoxifen works in reducing breast density     in premenopausal women with breast cancer or at high risk of developing breast cancer.   "
171845|NCT00081575|"     To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of     subjects with CAP requiring hospitalization.   "
171735|NCT00086567|"     This study will develop a blood test that can be used to predict a relapse of ovarian,     peritoneal, or fallopian tube cancer. The type of testing is called proteomics, or the study     of proteins in living cells. The test will identify certain proteins that might represent a     pattern, or fingerprint, indicating increased risk of disease relapse.      Women with Stage III or IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian     tube cancer that is in remission may be eligible for this study. Candidates are screened with     a medical history and physical examination, blood tests, review of pathology report from     surgery, and computed tomography (CT) or magnetic resonance imaging (MRI) scans of the     abdomen and pelvis (and chest if the cancer spread to the chest).      Participants have a clinic visit every 3 months for a physical examination (including a     pelvic examination), blood draw for routine and research tests, and review of how they have     been feeling. Every 6 months they have CT scans of the abdomen, pelvis, and possibly the     chest. When a patient has been in remission for 4 years, blood draws are done every 6 months     and CT scans are done yearly. Patients whose cancer returns (based on a CA-125 blood test, CT     scans, or physical examination) end their participation in the study. Patients with an     abnormal CT scan or physical examination may be asked to undergo a tumor biopsy (surgical     removal of a piece of tumor tissue) for research purposes.   "
171736|NCT00086580|"     This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to     evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus     fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell     chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the     informed consent document may be entered on the study.   "
171737|NCT00086593|"     This is a 12-week study for the treatment of chronic persistent symptoms in participants with     schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics     who fulfill the screening criteria will be randomized to receive either an FDA-approved drug     or placebo in addition to the current treatment. Safety will be closely monitored through     vital signs, various tests, and blood and urine samples.   "
171738|NCT00086606|"     This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of     approximately 150 patients who have a history of immediate hypersensitivity reaction to     peanut protein.   "
171739|NCT00086619|"     Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone     strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment     increases bone formation less and less over time. This study will test whether increasing the     daily dose of PTH sustains its ability to improve bone formation, and optional sub-studies     will test several potential reasons why PTH's effects on bone formation decline over time.   "
171740|NCT00086632|"     An experimental treatment with OvaRex® MAb-B43.13 (oregovomab), called immunotherapy is being     tested in ovarian cancer patients. Immunotherapy causes the body's defenses to react against     cancer cells. The purpose of this research study is to determine if immunotherapy with     oregovomab can create an immune response and enable the body to fight the disease and help     ovarian cancer patients live longer. Patients with a possible diagnosis of ovarian cancer     will be screened for study participation pre-surgery and, if eligible, will receive     oregovomab during front-line chemotherapy treatment for ovarian cancer and quarterly for     about a year following chemotherapy. Patients who experience disease progression will be     discontinued from oregovomab therapy. Patients will also have urine, blood and tissue samples     collected to assess the immune response to oregovomab.   "
171741|NCT00086645|"     This study will determine the efficacy and safety of citalopram compared to placebo in the     treatment of children with autism.   "
171742|NCT00086658|"     Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms     which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells,     various end-organ damages (including skin, heart, lung, nervous system and digestive system     etc.), and with exclusion of known secondary causes of hypereosinophilia.      HES has a high morbidity/mortality rate. The major treatment of HES has been systemic     corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon)     with the intention to lower eosinophil counts and therefore to slow down the progression of     disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia     in some patients, some may eventually become nonresponsive and intolerable to the amount of     side effects of the long-term therapy with these medications.      Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5     (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective     in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES     clinical signs and symptoms. This study intends to further evaluate the     corticosteroid-sparing and clinical benefit of mepolizumab in HES.   "
171743|NCT00086671|"     The objective of the trial is to study the safety and effectiveness of ABT-874 administered     weekly or every other week in patients with relapsing remitting and secondary progressive     multiple sclerosis as compared to placebo. Effectiveness will be measured based on MRI scans     done periodically throughout the study.   "
171744|NCT00086684|"     The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate     sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo     for 24 weeks for the relief of bladder pain or discomfort associated with interstitial     cystitis.   "
171745|NCT00086710|"     A total of 26 patients will be admitted to the clinic where they will be dosed with each     injection device. There will be a 7-day washout between doses and a 7-10 day follow-up     period.   "
171746|NCT00086723|"     RATIONALE: Tissue plasminogen activator and captopril may help the body generate angiostatin.     Angiostatin may stop the growth of cancer by stopping blood flow to the tumor.      PURPOSE: This phase I/II trial is studying the side effects and best dose of tissue     plasminogen activator and captopril and to see how well they work in treating patients with     progressive metastatic cancer.   "
171792|NCT00087438|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic body     radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage     to normal tissue.      PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works     in treating patients with inoperable stage I or stage II non-small cell lung cancer.   "
171749|NCT00086762|"     RATIONALE: Mindfulness relaxation, a technique to help patients quiet their thoughts and     relax their bodies before and during chemotherapy, may reduce or prevent nausea and vomiting.     It may also help improve mental health, quality of life, and immune function in patients     receiving chemotherapy.      PURPOSE: This randomized clinical trial is studying mindfulness relaxation to see how well it     works compared to relaxing music or standard symptom management education in treating     patients who are receiving chemotherapy for newly diagnosed solid tumors.   "
171750|NCT00086775|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop     cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as     alemtuzumab and rituximab, can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Combining chemotherapy with     monoclonal antibody therapy may kill more cancer cells. It is not yet known whether     fludarabine is more effective when combined with alemtuzumab or with rituximab in treating     chronic lymphocytic leukemia.      PURPOSE: Randomized phase II trial to compare the effectiveness of combining fludarabine with     either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell     chronic lymphocytic leukemia.   "
171751|NCT00086801|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vinblastine, and gemcitabine,     work in different ways to stop cancer cells from dividing so they stop growing or die.     Combining more than one drug may kill more cancer cells.      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating     patients with newly diagnosed stage I or stage II Hodgkin's lymphoma.   "
171752|NCT00086827|"     This phase II trial is studying how well FR901228 works in treating patients with recurrent     small cell lung cancer. FR901228 may stop the growth of tumor cells by blocking the enzymes     necessary for their growth.   "
171753|NCT00086840|"     This phase II trial is studying how well CCI-779 works in treating patients with relapsed or     refractory chronic lymphocytic leukemia. Drugs used in chemotherapy, such as CCI-779, work in     different ways to stop cancer cells from dividing so they stop growing or die   "
171754|NCT00086866|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy     and comparing them to see how well they work in treating patients with stage III or stage IV     melanoma that cannot be removed with surgery.   "
171755|NCT00086879|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in     different ways to stop tumor cells from dividing so they stop growing or die. It is not yet     known whether erlotinib is more effective than temozolomide or carmustine in treating     recurrent glioblastoma multiforme.      PURPOSE: This randomized phase II trial is studying erlotinib to see how well it works     compared to temozolomide or carmustine in treating patients with recurrent glioblastoma     multiforme.   "
171756|NCT00086892|"     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so     they stop growing or die. Combining cetuximab with carboplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin     works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal     cancer.   "
171757|NCT00086931|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and capecitabine may make     tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving     chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be     removed.      PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin and     capecitabine when given together with radiation therapy and to see how well they work in     treating patients who are undergoing surgery for locally advanced cancer of the rectum. NOTE:     *The phase I portion of this trial closed 06/2005. The best dose of oxaliplatin and     capecitabine has been determined.   "
171758|NCT00086944|"     This phase I/II trial is studying the side effects and best dose of oblimersen when given     together with rituximab and combination chemotherapy and to see how well they work in     treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Monoclonal     antibodies such as rituximab can locate cancer cells and either kill them or deliver     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy,     such as ifosfamide, carboplatin, and etoposide, work in different ways to stop cancer cells     from dividing so they stop growing or die. Oblimersen may increase the effectiveness of     chemotherapy by making cancer cells more sensitive to the drugs   "
171775|NCT00087165|"     RATIONALE: GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. GTI-2040 may help docetaxel kill more     tumor cells by making them more sensitive to the drug.      PURPOSE: This phase II trial is studying how well giving GTI-2040 together with docetaxel and     prednisone works in treating patients with prostate cancer that has not responded to hormone     therapy.   "
171759|NCT00086957|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and either     kill them or deliver tumor-killing substances to them without harming normal cells. Drugs     used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from     dividing so they stop growing or die. Combining gefitinib and trastuzumab with docetaxel may     kill more tumor cells.      PURPOSE: This phase I/II trial is studying the best dose of docetaxel when given together     with gefitinib and trastuzumab in treating patients with metastatic breast cancer.   "
171760|NCT00086970|"     This randomized phase I trial is studying the side effects and best dose of     O(6)-benzylguanine when given together with ifosfamide and to see how well it works compared     to ifosfamide alone in treating patients with unresectable metastatic solid tumors. Drugs     used in chemotherapy, such as ifosfamide and O(6)-benzylguanine, work in different ways to     stop tumor cells from dividing so they stop growing or die. Combining ifosfamide with     O(6)-benzylguanine may kill more tumor cells   "
171761|NCT00086983|"     This phase I trial is studying the side effects and best dose of rebeccamycin analog and     oxaliplatin in treating patients with refractory solid tumors. Drugs used in chemotherapy,     such as rebeccamycin analog and oxaliplatin, work in different ways to stop tumor cells from     dividing so they stop growing or die. Combining more than one drug may kill more tumor cells   "
171762|NCT00086996|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in     different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make     tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving     chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be     removed.      PURPOSE: This phase II trial is studying how well giving oxaliplatin together with     fluorouracil and radiation therapy works in treating patients who are undergoing surgery for     stage II or stage III cancer of the esophagus or gastroesophageal junction.   "
171763|NCT00087009|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Beta-glucan     may increase the effectiveness of rituximab by making cancer cells more sensitive to the     monoclonal antibody.      PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when     given together with rituximab in treating young patients with relapsed or progressive     lymphoma or leukemia or with lymphoproliferative disorder related to donor stem cell     transplantation.   "
171764|NCT00087022|"     RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver     tumor-killing substances to them without harming normal cells. It is not yet known whether     monoclonal antibody therapy is effective in treating kidney cancer.      PURPOSE: This randomized phase III trial is studying monoclonal antibody therapy to see how     well it works in treating patients who have undergone surgery for nonmetastatic primary     kidney cancer.   "
171765|NCT00087035|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop     tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor     cells by blocking the enzymes necessary for their growth. Combining docetaxel with erlotinib     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel together with erlotinib     works in treating older patients with progressive prostate cancer that has not responded to     hormone therapy.   "
171766|NCT00087048|"     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line     therapy in treating patients with recurrent extensive-stage small cell lung cancer.   "
171767|NCT00087061|"     RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in     treating patients with recurrent or progressive primary malignant glioma.   "
171768|NCT00087074|"     This phase II trial is studying how well CCI-779 works in treating patients with soft tissue     sarcoma or gastrointestinal stromal tumor. Drugs used in chemotherapy, such as CCI-779, work     in different ways to stop tumor cells from dividing so they stop growing or die.   "
171769|NCT00087087|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to     stop tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating     patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.   "
171770|NCT00087100|"     RATIONALE: Drugs used in chemotherapy such as pemetrexed disodium work in different ways to     stop tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating     patients with persistent or recurrent endometrial cancer.   "
171771|NCT00087113|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to     stop tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating     patients with recurrent cancer of the cervix.   "
171772|NCT00087126|"     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well topotecan works in treating women with     persistent or recurrent cervical cancer.   "
171773|NCT00087139|"     Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells     from dividing so they stop growing or die. This phase II trial is studying how well     ixabepilone works in treating patients with metastatic prostate cancer that has not responded     to previous hormone therapy.   "
171774|NCT00087152|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes     necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Combining     imatinib mesylate with capecitabine may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with     capecitabine works in treating women with progressive stage IV breast cancer.   "
171776|NCT00087178|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, epirubicin, cyclophosphamide,     and doxorubicin, work in different ways to stop tumor cells from dividing so they stop     growing or die. It is not yet known which combination chemotherapy regimen is more effective     in treating breast cancer.      PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to     compare how well they work in treating women who have undergone surgery for breast cancer     that has not spread to the lymph nodes.   "
171777|NCT00087191|"     This clinical trial is studying the amount of EF5 and motexafin lutetium present in tumor     cells and/or normal tissues of patients with abdominal (such as ovarian, colon, or stomach     cancer) or non-small cell lung cancer. EF5 may be effective in measuring oxygen in tumor     tissue. Photosensitizing drugs such as motexafin lutetium are absorbed by tumor cells and,     when exposed to light, become active and kill the tumor cells. Knowing the level of oxygen in     tumor tissue and the level of motexafin lutetium absorbed by tumors and normal tissue may     help predict the effectiveness of anticancer therapy   "
171778|NCT00087204|"     This phase I trial is studying the side effects and best dose of rebeccamycin analog in     treating patients with relapsed or refractory acute myeloid leukemia, myelodysplastic     syndrome, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blast phase. Drugs     used in chemotherapy, such as rebeccamycin analog, work in different ways to stop cancer     cells from dividing so they stop growing or die   "
171779|NCT00087217|"     This phase I trial is studying the side effects and best dose of     17-N-allylamino-17-demethoxygeldanamycin when given together with paclitaxel in treating     patients with metastatic or unresectable solid tumor. Drugs used in chemotherapy, such as     17-N-allylamino-17-demethoxygeldanamycin and paclitaxel, work in different ways to stop tumor     cells from dividing so they stop growing or die. Combining     17-N-allylamino-17-demethoxygeldanamycin with paclitaxel may kill more tumor cells   "
171780|NCT00087256|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development of cancer. It is not yet known whether celecoxib is effective in preventing     polyps in patients with colon cancer.      PURPOSE: Randomized phase III trial to study the effectiveness of celecoxib in preventing the     development of polyps in patients who have undergone surgery for stage I colon cancer.   "
171781|NCT00087269|"     This phase II trial is studying how well erlotinib works in treating patients with stage I,     stage II, or stage IIIA non-small cell lung cancer. Erlotinib may stop the growth of tumor     cells by blocking the enzymes necessary for their growth. Giving erlotinib before surgery may     shrink the tumor so that it can be removed.   "
171782|NCT00087282|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and flavopiridol, work in different     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one     drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving irinotecan together with     flavopiridol works in treating patients with advanced liver cancer.   "
171783|NCT00087295|"     RATIONALE: Drugs used in chemotherapy, such as FR901228 (depsipeptide), work in different     ways to stop tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with     advanced cancer of the urothelium that has progressed or recurred after receiving one     chemotherapy regimen.   "
171784|NCT00087334|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may     stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining     capecitabine and oxaliplatin with gefitinib may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine     when given together with oxaliplatin and gefitinib and to see how well they work in treating     patients with metastatic colorectal cancer.   "
171785|NCT00087347|"     RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) using ferumoxytol     may improve the ability to detect cancer that has spread to the lymph nodes and may help plan     effective cancer treatment.      PURPOSE: This clinical trial is studying how well MRI using ferumoxytol works in detecting     metastases to the lymph nodes in patients with primary prostate cancer or primary breast     cancer.   "
171786|NCT00087360|"     RATIONALE: Evaluating the knowledge and attitudes of healthy participants toward a new diet     and gene test for colorectal cancer risk may help doctors improve acceptance of colorectal     cancer screening.      PURPOSE: This clinical trial is studying the knowledge and attitudes of healthy participants     toward genetic and environmental risk assessment for colorectal cancer.   "
171787|NCT00087373|"     Vaccines may make the body build an immune response to kill tumor cells. Injecting a vaccine     directly into a tumor may cause a stronger immune response and kill more tumor cells. This     phase II trial is studying how well vaccine therapy works in treating patients with     metastatic melanoma.   "
171788|NCT00087386|"     This phase II trial is studying how well tanespimycin works in treating patients with stage     III or stage IV melanoma. Antitumor antibiotics such as tanespimycin may stop the growth of     melanoma by stopping blood flow to the tumor.   "
171789|NCT00087399|"     RATIONALE: Gabapentin may be effective in relieving hot flashes in women who have had breast     cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet     known whether gabapentin is more effective with or without antidepressants in treating hot     flashes.      PURPOSE: This randomized phase III trial is studying gabapentin and antidepressants to see     how well they work compared to antidepressants alone in treating hot flashes in women who     have had breast cancer or who have concerns about taking hormones to treat hot flashes.   "
171790|NCT00087412|"     This phase II trial is studying how well erlotinib works in treating patients with advanced     primary non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking     the enzymes necessary for their growth   "
171791|NCT00087425|"     RATIONALE: Drugs used in chemotherapy, such as bryostatin 1, work in different ways to stop     cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as     rituximab can locate cancer cells and either kill them or deliver cancer-killing substances     to them without harming normal cells. Bryostatin 1 may help rituximab kill more cancer cells     by making them more sensitive to the drug.      PURPOSE: This phase II trial is studying how well giving bryostatin 1 together with rituximab     works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia     that has not responded to previous treatment with rituximab.   "
171797|NCT00087503|"     This will be an international, multicenter, uncontrolled, 2-stage, phase II study in adult     patients with advanced gastric cancer, reasonable performance status, good organ function,     lack of serious concomitant medical conditions. Patients must have progressed or recurred     after a fluoropyrimidine-containing regimen at anytime for primary metastatic disease or     within 6 months of last dose of adjuvant therapy. Twenty-one evaluable patients will be     enrolled in Stage 1. If at least 2 objective tumor responses are observed in the first 21     evaluable patients, the study will be expanded to enroll a total of 41 evaluable patients.     Edotecarin will be administered at a starting dose of 13 mg/m2 as an IV infusion over 60     minutes in repeated 3-week cycles treatment.   "
171798|NCT00087516|"     The purpose of this clinical study is to determine the safety and efficacy of an     investigational drug in patients with type 2 diabetes mellitus.   "
171800|NCT00087542|"     The primary objective is to demonstrate that the investigational new drug, ACP-103, is well     tolerated by, and will not worsen parkinsonism in, patients with Parkinson's disease and     psychosis. The secondary objectives are to determine whether ACP-103 will ameliorate     psychosis in patients with Parkinson's disease and whether ACP-103 is safe in Parkinson's     disease patients taking multiple anti-parkinsonian medications.   "
171801|NCT00087555|"     The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when     used alone to treat the pain and sleep disturbances of fibromyalgia.   "
171802|NCT00087568|"     This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in     patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with     PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the     target sample size is >100 individuals.   "
171803|NCT00087581|"     This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF     combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or     tacrolimus, in participants who have undergone kidney transplantation. Participants will be     randomized to one of three dosing regimens to receive concentration-controlled MMF with     reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard     CNI. Participants will be followed for 20-24 months after randomization.   "
171804|NCT00087594|"     This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous     intravenous (iv) drug users who have CHC and are currently enrolled in a methadone     maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the     target sample size is <100 individuals.   "
171805|NCT00087607|"     This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and     PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on     study treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
171806|NCT00087620|"     To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2     twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily)     until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W).   "
171807|NCT00087633|"     This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of     prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to     initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection.     The anticipated time on study treatment was 3-12 months, and the target sample size was     100-500 individuals.   "
171808|NCT00087646|"     This 4 arm study is designed for patients with CHC who have not responded to peginterferon     alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening     the duration of treatment, as well as including an initial 12-week period of high-dose     PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS     (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment     is 1-2 years and the target sample size is 500+ individuals.   "
171809|NCT00087659|"     This study is being conducted to compare the effect of an investigational drug versus placebo     on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy     (ADT). The study drug or placebo will be administered every three months of four treatments     in one year.      In order to participate, male patients 18 years and older must be consecutive veterans from     participating Veterans Administration Medical Centers.   "
171810|NCT00087672|"     The goal of this clinical research study is to learn if CC-5013 (lenalidomide) can help to     control myelofibrosis. The safety of lenalidomide in the treatment of myelofibrosis will also     be studied.   "
171811|NCT00087685|"     The goal of this clinical research study is to learn if RAD001 can shrink or slow the growth     of tumors in patients who have recurrent endometrial cancer. The safety of this drug will     also be studied.      Objectives:      Primary Objective:      1. To determine the efficacy of RAD001 in patients with progressive or recurrent endometrial     cancer.      Secondary Objective:        1. To determine the nature and degree of toxicity of RAD001 in this cohort of patients.        2. To characterize, in pre- and post- treatment tumor samples, when available, expression          levels of total and phosphorylated mTOR (mammalian target of rapamycin) as well as          relevant upstream and downstream signaling components (optional).   "
171812|NCT00087698|"     This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus     cisplatin before surgery is at killing all the tumor so that none is left at the time of     surgery. Following surgery, all eligible patients will receive radiation to the chest. How     patients respond, whether the cancer returns and if so, where, will also be monitored.   "
171813|NCT00087711|"     This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to     gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC).     Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that     pemetrexed plus cisplatin may be as effective and may have fewer side effects than the     standard of care.   "
171868|NCT00088036|"     The purpose of the protocol is to evaluate the efficacy and safety of olanzapine compared     with placebo in patients with Borderline Personality Disorder (BPD).   "
171814|NCT00087724|"     The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels     of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease.     Patient visits are every six weeks with limited efficacy measurements at week 6 and 18.   "
171815|NCT00087737|"     To compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult     outpatients with MDD.   "
171816|NCT00087750|"     The purpose of this study is to assess the safety of intravenous (IV) cocaine in subjects     taking quetiapine at 3 dosage levels.   "
171817|NCT00087763|"     The purpose of this study is to determine if Macugen™ reduces foveal thickness and improves     vision in patients with wet AMD.   "
171818|NCT00087776|"     The primary objective of this trial is to compare the survival of patients with metastatic     malignant melanoma treated with Taxoprexin Injection to those treated with Dacarbazine. In     addition, the response rate to each drug, response duration, time to progression and time to     treatment failure will be measured. Toxicity will be evaluated and compared between the two     groups.   "
171819|NCT00087789|"     This is a Phase I clinical study to assess the safety, tolerability and biologic activity of     in vivo AAV-mediated delivery of CERE-110. Up to 12 subjects will receive open label CERE-110     in dose-escalating fashion. All subjects will receive bilateral, stereotactic injections of     CERE-110 for a total of four (Dose A and B) and six (Dose C) injections to target the basal     forebrain region of the brain containing the nucleus basalis of Meynert (NBM). All study     participants will be observed for a 24-month period and then followed annually.   "
171820|NCT00087802|"     The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin     (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response     and safety between the two drug combinations for the treatment of advanced non-small cell     lung cancer (NSCLC).   "
171821|NCT00087815|"     RATIONALE: Hyperbaric oxygen may increase blood flow and decrease swelling in areas of the     brain damaged by radiation therapy. Giving hyperbaric oxygen therapy together with     dexamethasone may be an effective treatment for radiation necrosis of the brain.      PURPOSE: This randomized clinical trial is studying how well hyperbaric oxygen therapy works     in treating patients with radiation necrosis of the brain.   "
171822|NCT00087828|"     The purpose of this study is to identify the substances in cranberry juice that make it     effective in reducing urinary tract infections (UTIs) in women.   "
171823|NCT00087841|"     The purpose of this study is to determine the effectiveness of self-hypnotic relaxation on     mental and physical distress during and after tumor treatment procedures.   "
171824|NCT00087854|"     The purpose of this study is to assess the safety and efficacy of Amonafide in men with     androgen-independent prostate cancer, assigned to individualized doses of Amonafide based on     acetylator phenotype information (doses adjusted on individual metabolism).   "
171825|NCT00087867|"     The main objective of this study is to assess the efficacy of SCIOS-469 as monotherapy in     relapsed, refractory patients with multiple myeloma (MM), based on response rates.   "
171826|NCT00087880|"     The purpose of this study is to evaluate the extended pharmacological and psychological     treatment for chronic cigarette smokers.   "
171827|NCT00087893|"     To investigate the relationship of vascular cell phenotypes to atherosclerosis.   "
171828|NCT00087906|"     To test a conceptual model of how disability develops in chronic obstructive pulmonary     disease (COPD).   "
171829|NCT00081341|"     This study investigates the effects of the glucocorticoid hormone cortisol on brain structure     and function. Patients with Cushing's disease are studied before and after treatment. Brain     imaging and neuropsychologic tests are used to study changes in the hippocampus and thinking     and learning functions as well as mood during the period of elevated cortisol. At several     intervals after treatment, these are reexamined to study the degree of reversibility of the     abnormalities. The contribution of cortisol as well as testosterone and estrogen to     dysfunction and recovery is studied. Since elevated cortisol and dysregulation of its     secretory system occurs in a significant proportion of the aged and in Alzheimers Disease and     Major Depressive Disorder, these studies will help advance knowledge of the role of cortisol     in these conditions.   "
171830|NCT00081354|"     Background:      The incidence rate for esophageal adenocarcinoma (EAC) has risen 10% per year over the past     two decades and is the most rapidly increasing cancer in the U.S.      Barrett's esophagus (BE), a metaplastic change from the normal squamous esophageal epithelium     to a specialized intestinal-type columnar mucosa, increases the risk of EAC by 30-125, and is     considered a precursor lesion for EAC.      Individuals diagnosed with BE are currently entered into endoscopic surveillance programs to     look for dysplasia or EAC. However, only 5% of subjects diagnosed with EAC have a previous     diagnosis of BE or have been part of a surveillance program, so alternative screening methods     are needed.      Objectives:      The primary goal of this project is to identify a practical blood-based biomarker(s) that can     be used as a screening test to determine who has BE and who does not.      Secondary goals of the project are to characterize germ-line and tissue biomarkers associated     with BE, and to compare biomarkers in non-BE patients with and without GERD.      Tertiary goals are to explore associations between biomarkers in blood or tissue and     progression from BE to dysplasia or EAC, and to assess the stability of proteomic patterns     over time.      Eligibility:      This study will be conducted among patients in the Barrett's Esophagus Registry (currently     with 206 registrants) established at the National Naval Medical Center (NNMC) in Bethesda     beginning in 1992, as well as a comparison group of approximately 600 matched non-BE patients     endoscoped in the GI clinic at NNMC for other conditions.      Design:      Blood and tissue samples will be collected as well as questionnaire data on risk factors and     medications as well as GERD.      Data analyses will be based primarily on laboratory testing of newly collected esophageal     biopsies, brush samples, and blood samples, but secondarily will also include use of archival     tissue biopsy samples.      Follow up of BE Registry patients will include standard periodic surveillance endoscopies,     additional blood samples, and ascertainment of disease status (i.e., progression).      To distinguish BE versus non BE-patients in this case-control study, we will:      assess predictability of BE status from serum proteomic patterns;      characterize esophageal biopsies and brush samples for selected DNA alterations, RNA     expression, and proteomic profiles;      genotype patients for selected polymorphisms potentially associated with BE;      compare blood and tissue biomarkers in non-BE patients with and without GERD;      explore the association of biomarkers with progression from BE to dysplasia or EAC;      assess proteomic pattern stability over time in BE patients.   "
171831|NCT00081367|"     This study will determine the effectiveness of cognitive behavioral therapy (CBT) in     preventing future suicide attempts in repeat suicide attempters.   "
171832|NCT00081380|"     The purpose of this study is to determine whether quetiapine when used as adjunct to lithium     or divalproex is safe and effective in the maintenance treatment of adult patients with     Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment     Phase and the Randomized treatment Phase.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
171833|NCT00081406|"     The purpose of this study is to compare three treatments to determine which is most effective     in reducing anxiety in children.   "
171846|NCT00081588|"     The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of     TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over     time and to evaluate the immunological effect over time.   "
171847|NCT00081601|"     The purpose of this study is to determine the proportion of patients with a serological     prostate specific antigen (PSA) by day 85.   "
171848|NCT00081614|"     The primary purpose of the study is to assess the potential benefit of combining two targeted     therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to     determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic     renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of     response, and survival compared with Avastin alone. Since Avastin has been shown to be active     in renal cancer, the goal will be to assess whether this activity can be enhanced with     Erlotinib.   "
171834|NCT00081419|"     This study will examine how the brain controls movement in people with Tourette syndrome and     chronic tic disorder to determine if the timing of movement is important in whether someone     feels in control of their movements. Although movements in tic disorders are often     characterized as involuntary, some patients claim that these movements are made     voluntarily, or they are unable to decide if they are voluntary or involuntary. Previous     experiments have shown that when people are asked to look at a clock and report the time they     first decide to make a movement they report times later than the first brain waves associated     with movement appear. When they are asked to report the time they first initiate the     movement, they report times before the muscles actually begin to move. This study may help     determine how the sense of willing and initiating an action is altered in patients with     Tourette syndrome and chronic tic disorder, and how people may feel more or less in control     of their movements.      Normal volunteers and patients with Tourette syndrome or chronic tic disorder between 18 and     65 years of age may be eligible for this study. Control subjects must not have any     neurological or psychological disorders, and patients with Tourette syndrome of chronic tic     disorder must not have any other neurological disorders. Patients with attention deficit     hyperactivity disorder (ADHD) may not enroll in this study.      All participants will have a medical history, physical examination, and a test to determine     their level of attention. Patients will be interviewed about their symptoms and complete     psychiatric rating scales. In addition, all participants will undergo the following     procedures:      Electric shock      Participants look at a clock on a computer screen, the hands of which revolves quickly. While     looking at the clock, each participant will be given small, non-painful electric shocks and     asked, according to the clock, to say when they received the shocks. The shocks are repeated     40 times.      Arm movement      Participants are asked to lift their arms off a table repeatedly, at random times, while they     look at the computer clock. This exercise is repeated 80 times. Of these 80, participants are     asked 10 times consecutively to say the time they first had the desire to move their arm, and     then 10 consecutively the time they first felt that they were moving their arm.      Electroencephalography (EEG) and Electromyography (EMG)      Participants undergo EEG and EMG durin...   "
171835|NCT00081432|"     This study uses functional magnetic resonance imaging (fMRI) and diffusion tensor imaging     (DTI) to examine how the brain processes tasks involving language and emotion in normal     volunteers and in patients with epilepsy. MRI is a diagnostic and research tool that uses a     strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI     scanner is a metal cylinder surrounded by a magnetic field. During the test, the subject lies     on a table that can slide in and out of the cylinder. DTI involves taking pictures of the     brain while the subject is at rest in order to learn about the structure of the brain.     Information gained from this study will help scientists evaluate the organization of language     and emotional functions in the brain.      Normal volunteers and patients with temporal lobe epilepsy 18 years of age and older who are     native English speakers and who will undergo surgery for uncontrolled seizures may be     eligible for this study. Candidates are initially screened by telephone, then with physical     and neurologic examinations and cognitive testing.      The study has two parts, conducted 6 to 12 months apart. Each part consists of the same sets     of tests described below, using fMRI and DTI. In patients with epilepsy, Part 1 is scheduled     before surgery and Part 2 after surgery.        -  fMRI: Subjects are asked to perform two types of tasks while they undergo fMRI. In one          task, they are shown pictures of animals and tools and are asked to name them. In a          second task, they are shown pictures that range in content from sexually explicit          material, to human injury and surgical slides, to pleasant images of children and          wildlife and are asked to decide whether they find the pictures pleasant, neutral, or          unpleasant.        -  DTI: Subjects relax and remain still in the MRI scanner for about 45 minutes.        -  Neuropsychological testing: Subjects may be asked to complete questionnaires, take          pen-and-paper or computerized tests, and perform motor tasks.      Participants may be asked to repeat the MRI studies, but not the neuropsychological tests, up     to four times to investigate different brain functions or to confirm findings.   "
171836|NCT00081458|"     The purpose of this study is to evaluate the efficacy, safety, tolerability, and     pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral     nutrition (PN)-dependent short bowel syndrome (SBS).   "
171837|NCT00081471|"     This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of     renal anemia in patients with chronic kidney disease who are not on dialysis and not     receiving epoetin or any other erythropoietic substance. The anticipated time on study     treatment is 1-2 years and the target sample size is 100-500 individuals.   "
171838|NCT00081484|"     This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc)     Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in     chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin.     The anticipated time on study treatment is 3-12 months and the target sample size is 100-500     individuals.   "
171839|NCT00081497|"     People with Fabry Disease have an alteration in their genetic material (DNA) which causes a     deficiency of the alpha-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that     helps to break down and removes certain types of fatty substances called glycolipids. These     glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids     build up in various tissues such as the liver, kidney, skin, and blood vessels because     a-galactosidase A is not present, or is present in small quantities. The build up of     glycolipid (globatriaosylceramide or GL-3) levels in these tissues in particular is thought     to cause the clinical symptoms that are common to Fabry disease. This study analyzed the     safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease that     previously participated in the AGAL-008-00 (NCT0074984) study.   "
171840|NCT00081510|"     Primary Objective(s):        -  To compare the activity (progression-free survival [PFS]) of anastrozole in combination          with lonafarnib to that of anastrozole in combination with placebo in subjects with          hormone-sensitive ADVANCED breast cancer.      Secondary Objective(s):        -  To determine the effects of anastrozole in combination with lonafarnib on objective          response, duration of response, overall survival, and safety in subjects with advanced          breast cancer. To assess the exposure and pharmacokinetics of lonafarnib and anastrozole          in the subject population.   "
171841|NCT00081523|"     This study is not a treatment protocol and no experimental treatments are involved. Study     participants may be seen as needed for clinical, translational and basic research studies, or     as medically indicated. Subjects will receive their general medical care outside the NIH and     will be seen at our clinic or at CNHS with varying frequency. Subjects may be seen for     multiple visits. Subjects may be asked to return for additional testing as needed. Clinical     care for patients with sickle cell disease will be provided as appropriate through the Sickle     Cell Clinic and the inpatient clinical center.   "
171842|NCT00081536|"     This study is a Phase I/II study. In Phase I of this study, the objective is to determine the     maximum tolerated dose (MTD) of combination therapy with Aroplatin and capecitabine in     subjects with unresectable, local recurrence or distant metastases of colorectal cancer     refractory to 5-FU/leucovorin and irinotecan. In Phase II, the primary objective is to     evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Secondary     objectives are to evaluate frequency and severity of adverse events.   "
171843|NCT00081549|"     This study is a Phase I/II study. In Phase I of this study, the objective is to determine the     maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®)     in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. In Phase     II, the primary objective is to evaluate survival after therapy with Aroplatin and     gemcitabine at the identified MTD in subjects with unresectable, locally advanced and/or     metastatic pancreatic cancer. Secondary objectives are to evaluate the severity and quantity     of adverse events and determine the proportion of non-progressors and the progression-free     interval.   "
171850|NCT00081640|"     PRO 2000 Gel is designed to be inserted into the vagina to protect women from getting HIV     during sex. So far, PRO 2000 Gel has been tested for safety in 136 women from Europe and the     United States. This study will evaluate the safety and acceptability of PRO 2000 Gel when     used by women in Pune, India. The study will also examine what Indian women and men think     about using PRO 2000 Gel.   "
171851|NCT00081653|"     This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg     or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed     Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly,     or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and     calcium. The anticipated time of study treatment is 2+ years, and the target sample size is     500+ individuals.   "
171852|NCT00081666|"     To use a new statistical method, the Logical Analysis of Data (LAD), to predict cardiac     surgery risk.   "
171853|NCT00081679|"     To further characterize the nature of the association between socioeconomic status (SES),     health behaviors and early cardiovascular disease in the Vietnam Era Twin (VET) Registry, a     sample of over 4,000 twin pairs.   "
171854|NCT00081692|"     To relate cardiac structure and blood pressure (BP) elevation in adults to childhood BP and     body size and composition.   "
171855|NCT00081705|"     To measure the association between estrogen receptor variants and the extent of     atherosclerosis in the thoracic and abdominal aorta and the right coronary artery in subjects     in the PDAY study.   "
171856|NCT00081731|"     This study will compare medical therapy plus stenting of hemodynamically significant renal     artery stenoses versus medical therapy alone in patients with systolic hypertension and renal     artery stenosis.   "
171857|NCT00081744|"     Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate     clinical situations.   "
171858|NCT00081757|"     The purpose of this study is to evaluate the use of thalidomide for the treatment of cancer.     Patients with many types of cancers will be enrolled because the researchers will also study     how the different cancers respond and what kind of side effects patients will experience.   "
171859|NCT00081770|"     The objective is to compare the safety and efficacy of the following three treatment regimens     in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1)     PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2)     PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3)     PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.   "
171860|NCT00087919|"     To investigate the genetic basis of obesity by fine mapping an obesity quantitative trail     linkage (QTL) linked to chromosome 3q.   "
171861|NCT00087932|"     The purpose of this study is to determine whether differences in the use of complementary and     alternative medicine (CAM) are influenced by the socioeconomic status and ethnicity of cancer     patients.   "
171862|NCT00087945|"     The way abacavir (ABC) behaves in the body differs between children and adults, but little is     known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for     adolescents. The purpose of this study is to determine the blood levels of ABC in HIV     infected adolescents who are on ABC-containing regimens.   "
171863|NCT00087958|"     The purpose of this clinical trial is to determine if the investigational drug is able to     reduce/shrink advanced breast cancer tumors in patients who no longer benefit from     anthracyclines, taxanes and capecitabine.   "
171864|NCT00087984|"     The purpose of this trial is to examine the safety, feasibility, immunological response, and     clinical antitumor activity of administering a dendritic cell vaccine to patients with     metastatic renal cell carcinoma.   "
171865|NCT00087997|"     The purpose of this study is to evaluate the safety and effectiveness of an experimental     study drug (STA-4783) combined with an approved cancer medicine, paclitaxel, in the treatment     of soft tissue sarcomas. Paclitaxel (Taxol®) has been approved and used in the United States     since 1992.   "
171866|NCT00088010|"     The purpose of this trial is to study:        -  Effects of arzoxifene on bone fractures and bone mass.        -  Effects of arzoxifene on getting breast cancer.        -  Effects of arzoxifene on certain types of cardiovascular events, such as heart attack          and stroke.        -  Effects of arzoxifene that changes the amount of certain substances in the blood that          are related to osteoporosis and cardiovascular health.        -  Effects of arzoxifene on the uterus.        -  The safety of arzoxifene and any side effects.   "
171867|NCT00088023|"     The purpose of this study is to determine the safety of a short intravenous infusion of     PT-523 to patients with solid tumors who have failed curative or survival prolonging therapy     or for whom no such therapies exist.   "
171871|NCT00088075|"     A clinical study to evaluate the efficacy, safety and tolerability of two dose ranges of     risperidone (1 to 3 mg/day, and 4 to 6 mg/day) versus placebo (an inactive substance like a     sugar pill) in adolescents (aged 13 to 17 years) with schizophrenia (i.e. abnormal behavior     and thoughts). The study duration is about 6 to 7 weeks.   "
171872|NCT00088088|"     This study is for patients who have Stage IIIb or Stage IV NSCLC and have never had     chemotherapy before for their disease. The first phase of the study recently completed and     for the second phase of the study patients are randomly assigned to receive either paclitaxel     and carboplatin or paclitaxel and carboplatin and study drug (STA 4783). Treatment will be     every 3 weeks for 6 cycles.   "
171873|NCT00088101|"     The purpose of this study is to determine the safety, toxicity and patient tolerance of     STA-5312 administered intravenously to patients with relapsed or refractory hematological     malignancies and patients with solid tumors.   "
171874|NCT00088114|"     The purpose of this study is to determine the safety, toxicity and maximum tolerated dose of     single doses of STA-4783/paclitaxel in combination when administered intravenously to     patients with refractory cancer. To determine the pharmacokinetics of STA-4783 and paclitaxel     when co-administered.      To assess the anti-tumor activity of STA-4783 and paclitaxel when co-administered.   "
171875|NCT00088140|"     The purpose of this study is to determine if IDN-6556, when given orally, is safe and     effective in patients with chronic hepatitis C virus infection.   "
173712|NCT00107744|"     The purpose of this randomized, double-blind, controlled trial is to examine the effect of     soybean protein supplementation on blood pressure in persons with prehypertension or stage-1     hypertension.   "
171876|NCT00088153|"     This study is to determine the effects of anorexia nervosa on bone mass and hormone levels in     adolescents. Whether administration of estrogen, a normal hormone present during puberty, can     help maintain bone development in girls with anorexia nervosa will be determined.   "
171877|NCT00088166|"     The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone     (Decadron) a common treatment for symptoms of brain swelling (edema). This study is     specifically aimed at patients who require chronic high doses of dexamethasone to manage     symptoms.   "
171878|NCT00088179|"     During a heart bypass procedure, a substance called complement is activated by the body.     This complement activation causes an inflammatory response that can lead to side affects     such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study     is to find out if the study drug (pexelizumab), that blocks complement activation, can     reduce such side effects and be given safely to patients requiring the bypass procedure with     the use of the heart-lung machine.   "
171879|NCT00088192|"     To provide Pegaptanib sodium injection to patients with subfoveal choroidal     neovascularization (CNV) secondary to AMD, who are unable to participate in any of the     Sponsor’s other clinical studies with this drug for AMD, until such time as the patient’s     lesion is considered to have resolved or stabilized in the opinion of the treating     ophthalmologist, or product becomes commercially available.   "
171880|NCT00088205|"     The purposes of this study are to determine the safety of oral enzastaurin HCl and any side     effects that might be associated with it and whether enzastaurin HCl can help patients with     Mantle Cell Lymphoma.   "
171881|NCT00088218|"     The goal of this clinical research study is to study how effective treatments with     clofarabine alone and clofarabine given in combination with ara-C are in the treatment of     leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older.     The safety of these treatments will also be compared.   "
171882|NCT00088231|"     The goal of this clinical research study is to find the highest safe doses of PTK 787     (vatalanib) and Gleevec (imatinib mesylate) that can be given to treat Chronic Myelogenous     Leukemia-Blastic Phase (CML-BP), Refractory Acute Myelogenous Leukemia (AML), or Agnogenic     Myeloid Metaplasia (AMM). Another goal is to see how effective this combination treatment is.   "
171883|NCT00088257|"     To study pre- and post-natal influences on the development of childhood asthma-related immune     responses.   "
171884|NCT00088270|"     Multi-center, randomized Phase II study to evaluate the efficacy and safety of     OSI-7904Lversus 5 FU/LV in biliary tract cancer.   "
171885|NCT00088283|"     Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug,     MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not     been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may     slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the     eye.      The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a     “pretend” injection. In addition, the purpose of this study is to measure the action of the     study drug in the body over a period of time and to check for the presence of the study drug     in your blood (called pharmacokinetics or PK).      This study will involve approximately 90 people. People who decide to participate will have     an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™     and one of which is a “pretend” injection.   "
171886|NCT00090168|"     A 6-week treatment study to compare the reduction in cholesterol of two drugs     MK0653A+Simvastatin for high cholesterol, in patients with hypercholesterolemia and     atherosclerotic or coronary vascular disease.   "
171887|NCT00090181|"     The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic     low back pain and to investigate the overall safety and tolerability over four weeks of     treatment.   "
171888|NCT00090194|"     The purpose of this study is to determine if IGIV-C, 10% will be effective in converting a     donor-recipient crossmatch status from positive to negative. The crossmatch test is used to     determine if the donor tissue and recipient tissue are compatible. The study will also     evaluate if IGIV-C, 10% will allow successful kidney transplantation in a patient who     otherwise would not be able to receive a transplant. Three dose levels of IGIV-C, 10% will be     evaluated to determine what dose level is most effective.   "
171889|NCT00090207|"     A multicenter trial to assess the safety and efficacy of an investigational drug in the     prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed     solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The     study will evaluate the investigational drug for the treatment of CINV during the first cycle     of treatment with cisplatin.   "
171890|NCT00090220|"     This study was conducted to assess the safety, immunogenicity, efficacy and long-term     effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV)     infection and disease in mid-adult women.   "
171892|NCT00090246|"     The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug     for a new indication in the prevention of postoperative nausea and vomiting in patients     receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.   "
171893|NCT00090259|"     This is a multicenter study to evaluate potential decrease in hospitalization events and time     between events and increasing longevity in patients with symptomatic congestive heart failure     and intolerant of first-line medication for heart failure. This study will evaluate if higher     doses of the investigational drug given daily will be superior to the lower dose of the same     investigational drug given daily.   "
171894|NCT00090272|"     The objective of this study is to evaluate the safety and efficacy of a one time dose of an     intravenous marketed drug being evaluated for a new indication as compared to a marketed drug     already approved for the prevention of surgical site infection following colorectal surgery.   "
171926|NCT00090727|"     The purposes of this study are to determine:        -  the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4          week cycle        -  the side effects of AQ4N when given on the above schedule        -  how much AQ4N is in the blood and urine at specific times after administration and how          the body get rids of AQ4N        -  if AQ4N helps treat cancer   "
171927|NCT00090740|"     The purpose of this study is to determine whether a specific genetic factor influences the     severity of asthma symptoms.   "
171895|NCT00090285|"     This study is to evaluate an investigational vaccine with the following objectives: to     demonstrate that the vaccine is well tolerated in young men; to demonstrate that the vaccine     reduces incidence of external genital lesions (Condylomata acuminata [anogenital warts],     penile/perianal/perineal intraepithelial neoplasia [PIN], penile, perianal, perineal cancer)     in young men; to demonstrate that the vaccine reduces the incidence of anal intraepithelial     neoplasia (AIN) or anal cancer in men having sex with men (MSM); and to demonstrate that the     vaccine reduces incidence of Human Papilloma Virus (HPV) infection in young men.   "
171896|NCT00090298|"     A 10-week study to compare the reduction in cholesterol following treatment with two     different marketed drugs in patients with hypercholesterolemia.   "
171897|NCT00090311|"     The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate     (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with     Bipolar I mania.   "
171898|NCT00090324|"     The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate     (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia.   "
171899|NCT00090337|"     RATIONALE: Acupuncture may help relieve pain and dysfunction caused by cancer surgery. It is     not yet known whether acupuncture is more effective than standard therapy in treating pain     and dysfunction in patients who have undergone neck surgery for head and neck cancer.      PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works     compared to standard therapy in treating pain and dysfunction in patients who have undergone     neck surgery for head and neck cancer.   "
171900|NCT00090363|"     This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating     prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo     (sugar pill). The study will also provide further information on the safety of ZD4054     (Zibotentan).   "
171901|NCT00090376|"     In this phase II study, an investigative (not approved by the FDA) drug called GPI 1485 is     being assessed to see if it can help preserve erectile function after prostatectomy.   "
171902|NCT00090389|"     The purpose of this study is to evaluate the safety and effectiveness of acupuncture in     treating women's health conditions.   "
171903|NCT00090402|"     The purpose of this study is to determine the effect of fish oil and the antioxidant alpha     lipoic acid on factors in the blood that are associated with the progression of Alzheimer's     Disease (AD).   "
171904|NCT00090415|"     This study will identify factors that distinguish children with autism from children with     developmental delay and those with normal development and study the efficacy of intensive     behavioral therapy in children with autism.   "
171905|NCT00090428|"     This study will determine whether a gluten- and casein-free diet has specific benefits for     children with autism.   "
171906|NCT00090441|"     To investigate the role in coronary heart disease (CHD) of intragenic variation in a network     of six genes affecting lipoprotein transport and metabolism.   "
171907|NCT00090454|"     To investigate the association of selected genetic markers of inflammation and endothelial     activation with the occurrence of non-fatal acute myocardial infarction (MI).   "
171908|NCT00090467|"     To investigate biochemical and genetic markers of inflammation and endothelial dysfunction as     determinants of hypertension.   "
171909|NCT00090480|"     This 2-phase study will determine the safety of treating patients with breast cancer with the     genetically engineered HyperAcute-Breast cancer vaccine. It will establish the proper vaccine     dose and will examine side effects and potential benefits of the treatment. The vaccine     contains killed breast cancer cells containing a mouse gene that causes the production of a     foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response     to the foreign substance will stimulate the immune system to attack the patient's own cancer     cells that have similar proteins without this sugar pattern, causing the tumor to remain     stable or shrink.      Patients 18 years of age or older with breast cancer that has recurred or no longer responds     to standard treatment may be eligible for this study. Candidates will be screened with     medical history and physical examination, blood tests, urinalysis, chest x-rays and CT scans.     MRI, PET, and ultrasound scans may be obtained if needed.      Participants will receive four vaccinations a month apart from each other. The vaccines will     be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of     the study will treat successive groups of patients with increasing numbers of the vaccine     cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will     look for any beneficial effects of the vaccine given at the highest dose found to be safe in     Phase I. Weekly blood samples will be drawn during the 4 months of vaccine treatment. In     addition, patient follow-up visits will be scheduled every 2 months for the first year after     vaccination and then every 3 months for the next 2 years for the following tests and     procedures to evaluate treatment response and side effects:        -  Medical history and physical examination        -  Blood tests        -  X-rays and various scans (nuclear medicine/CT/MRI)        -  FACT-B Assessment questionnaire to measure the impact of treatment on the patient's          general well-being. The questionnaire is administered before beginning treatment, before          each vaccination, and during follow-up visits after completing the treatment. It          includes questions on the severity of breast cancer symptoms and the ability to perform          normal activities of daily life.   "
171910|NCT00090493|"     The hope is that the peptide vaccines will stimulate the immune system to attack and kill the     myeloma cells. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells     and nothing else.   "
171911|NCT00090506|"     The purpose of this study is to plan and develop an international collaboration for research     on the health effects of yoga. This study will also determine the effects of yoga on people     who are at an increased risk for developing diabetes and people with both HIV and depression.   "
171912|NCT00090519|"     The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an     eye disease called macular edema in patients with diabetes.   "
174015|NCT00120315|"     The purpose of this study is to determine how many chronic users of antisecretory medication     can stop after a test for a bacteria associated with peptic ulcer disease.      This is evaluated in a discontinuation trial.   "
171928|NCT00090753|"     This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or     subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients     with renal anemia. Eligible patients were those who were receiving stable maintenance therapy     with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in     Phase II or III clinical studies. They continued to receive methoxy polyethylene     glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of     administration (sc or iv) as in the qualifying studies.   "
171929|NCT00090766|"     This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid     organ transplant recipients. The anticipated time on study treatment is 3-12 months and the     target sample size is less than 100 individuals.   "
171914|NCT00090545|"     BAY 43-9006 (Sorafenib) is an experimental cancer drug produced by Bayer Health Care     Corporation. It represents a new class of anticancer agents known as bi-aryl ureas. This     study will investigate its effect on prostate cancer and its side effects. Researchers expect     to enroll a maximum of 46 men with prostate cancer for this study. The duration of the study     will depend on its results.      Before beginning to take the drug, patients will be admitted to the hospital for 2 days, have     a medical examination and give blood samples, and have a tumor or bone marrow biopsy. On the     first day of the study, patients will begin taking the drug as 2 tablets twice daily, morning     and evening. Blood will be taken throughout the day to determine the drug's level in the     bloodstream.      Patients will be discharged from the hospital on the second day, and will continue to take     the drug twice daily until instructed to stop. During each of the first 4 weeks, patients     will be required to have their blood pressure checked. At the end of the first 4 weeks,     patients will have a physical examination and blood tests, as well as a second tumor or bone     marrow biopsy.      After the first 4 weeks, patients will continue with their drug regimen. At the end of each     4-week cycle, patients will have a physical examination and blood tests. Patients will also     have x-Rays, computed tomography (CT) scans, and/or magnetic resonance imaging (MRIs) at     every other 4-week examination or as required. Patients will be asked to keep a diary     recording the time and amount of their medication for this study.   "
171915|NCT00090558|"     Regular exercise reduces the risk of heart problems, in part because it improves the work of     the endothelium (the cells that line blood vessels). Exercise appears to release precursor     cells from the bone marrow that will later become endothelial cells. A molecule called nitric     oxide (NO) appears to be involved in this release. However, some heart patients do not     improve their endothelial function despite regular exercise. The researchers believe that the     heart disease in these patients may interfere with the normal relationship between exercise     and endothelial function. This study is designed to test whether giving a patient     nitroglycerin (which is converted to NO in the bloodstream) will increase the release of     endothelial precursor cells from the bone marrow. If the study succeeds, it may lead to     improved healing of arteries in heart disease patients.      Adults may be eligible for this study if they have coronary artery disease and do not take     nitroglycerin or nitroglycerin-like medication on a daily basis.      Volunteers will be admitted to the Clinical Center on 2 separate nights at least 1 week     apart. On the morning after each admission, volunteers will have blood drawn from an arm vein     for laboratory tests, and then walk on a treadmill until fatigue or discomfort prevents     further exercise, or until asked to stop. On one of their admissions, volunteers will receive     1 tablet of nitroglycerin under the tongue shortly before the treadmill test. Volunteers will     be monitored by EKGs and blood pressure tests during the treadmill tests, and will have more     blood drawn at about 15 minutes and 24 hours after each treadmill test. Researchers will     examine the levels of endothelial precursor cells and nitric oxide in the blood samples taken     before and after exercise.   "
171916|NCT00090571|"     Juvenile rheumatoid arthritis (JRA) is the most common chronic inflammatory disease in     children, and may be related to genetics. Having two siblings who both have JRA in one family     is rare. The purpose of this registry is to collect patient information and blood samples     from qualifying JRA siblings and their families. The goal of the registry is to further     understanding of JRA as related to genetics.   "
171917|NCT00090584|"     The primary aim of this study is to test if the addition of behavioral treatment to drug     therapy for the treatment of urge incontinence will increase the number of patients who can     discontinue drug therapy and sustain a significant reduction of incontinence.   "
171918|NCT00090610|"     The purpose of this study is to compare the progression-free survival of two treatment     regimens for relapsed ovarian cancer.   "
171919|NCT00090623|"     This is a phase III, multicenter, randomized, double masked, sham injection-controlled study     of the efficacy and safety of intravitreally administered ranibizumab in subjects with     subfoveal choroidal neovascularization secondary to age-related macular degeneration.   "
171920|NCT00090649|"     To compare the antidepressant efficacy and safety of DVS-233 SR with those of placebo in     adult outpatients with MDD.   "
171921|NCT00090662|"     Increased numbers of white blood cells called eosinophils can cause disease. To investigate     this disease, researchers need normal blood and bone marrow samples to compare to samples     from patients with this problem. This study will collect blood and bone marrow samples from     normal volunteers who meet standard blood donor criteria. Some of the samples will be used     for genetic testing or future research.      This study will last for about 3 years and will include a maximum of 50 paid volunteers ages     18 to 65.      After a medical screening, volunteers will donate a blood sample and a bone marrow sample,     taken from the hip bone, followed by a biopsy that will obtain a small sample of bone and     bone marrow. The procedure lasts less than 1 hour. Volunteers may donate repeatedly within     the limits set by the study.   "
171922|NCT00090675|"     In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced     or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV)     who have SD or objective tumor response immediately following the completion of 4-6 cycles of     front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner     to receive either ZD1839 or placebo.   "
171923|NCT00090688|"     The study will enroll approximately 60 volunteers. The vaccine is given as a drink in     flavored soda water. Volunteers will either receive a 3-dose vaccination with doses spaced     two weeks apart or a 4-dose vaccination with doses spaced 2 days apart depending upon their     availability for follow-up.      Once assigned to a vaccination schedule, volunteers will be randomly assigned to receive the     meCS6 vaccine with or without the mLT adjuvant for all vaccine doses. Neither the study     investigators nor the volunteers will know which group they are assigned.      Volunteers will be asked to be available for clinic visits and telephone follow-ups during     the study period and provide blood and stool specimens for testing.   "
171924|NCT00090701|"     The primary objective of this study is to determine safety and activity of a novel anticancer     agent in patients with metastatic non-small cell lung cancer who failed 2 or 3 prior systemic     treatments.   "
171925|NCT00090714|"     The purpose of this study is to determine the optimum effective dose of recombinant plasmid     DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct injection     catheter (Stiletto™) system needed to benefit patients with severe Angina Pectoris.   "
171930|NCT00090779|"     Although some doctors favor starting anti-HIV treatment as soon as possible after patients     learn they are infected, it is not known if treatment for recently infected patients results     in long-term benefits or harm. The purpose of this study is to learn whether or not people     should take anti-HIV drugs when they are first infected.   "
171931|NCT00090818|"     This study will screen patients for eligibility in studies sponsored by the Craniofacial     Genetics Section (HCGS), the Clinical Research Core (CRC), and other branches located within     the National Institute of Dental and Craniofacial Research (NIDCR). It will also evaluate     patients with diseases or abnormalities of the oral cavity or craniofacial complex, or both,     for future protocol development. HCGS and CRC study the natural history of oral diseases and     systemic diseases that are manifested in the maxillofacial region-the upper jaw and face.     Among the diseases are lichen planus, systemic lupus erythematosus, and premalignant oral     leukoplakia. Researchers also study certain acquired diseases and genetic diseases. Because     many of the diseases of the maxillofacial region are poorly defined, the evaluation and     characterization of patients with such diseases are goals of investigation.      Patients of any age, gender, and racial and ethnic group who have oral diseases or systemic     diseases of the upper jaw and face may be eligible for the study. Women of childbearing     potential, or who are pregnant or lactating, may be eligible; they would undergo procedures     and tests or receive medications posing a minimal risk to the fetus or child.      Participants will undergo the following procedures:        -  Complete medical history and physical examination, including a thorough examination of          the head and neck; detailed examination of the teeth and gums may or may not be          necessary.        -  Tests of blood, urine, stool; tests for pregnancy and HIV when needed; and tests for          cultures, fungi, bacteria, and parasites.        -  Sampling of blood and oral tissues for diagnosis, treatment response, and disease          progression.        -  Electrocardiogram, x-ray, and imaging procedures, including imaging of the face.      Biopsies may be performed as needed for diagnosis and to guide therapy. The type, number,     location, and frequency of biopsies depend on several factors, including the nature of the     disease being evaluated. Local anesthesia is typically used unless there are     contraindications. Some biopsies are done with disposable, 2 to 3 mm, round, sharp metal     punches. Larger excisions with the use of an appropriate blade may be necessary for proper     evaluation of a patient's condition or complete removal of something that is abnormal. The     risks and discomfort associated with any of the interventions include mild pain, bleeding,     and infection; there may be temporary facial paralysis, bruising, and allergic reactions.      Supportive care will be given as needed, according to the patient's diagnosis, treatment, and     clinical information. Disease-related or drug-related complications, or both, will be managed     through collaboration with the patient's referring physician.   "
171932|NCT00090831|"     This study will examine the role of serotonin function in the brain. Serotonin, one of the     brain's natural chemicals, connects with receptors on brain cells to regulate emotion,     anxiety, sleep, stress hormones, and other body functions that are disturbed in various mood     and anxiety disorders. Also, the research will look at the function of particular brain     areas, how they are involved in regulating emotions, and how serotonin is involved in the     regulation of their function. The procedures entailed are tryptophan depletion and magnetic     resonance imagining (MRI). Also, researchers' understanding of the genetic causes of mood and     anxiety disorders will increase through examination of participants' DNA.      Adults in good health, ages 20 through 50, may be eligible for this study. Among those not     eligible are females who are pregnant or breast feeding, patients with psychiatric or central     nervous system disease, and those taking medications that would interfere with study results.      At the first visit, patients will be asked about their general mood, degree of nervousness,     thinking skills, and behavior. The session will last from 1.5 to 2.0 hours. A blood sample of     about 2 tablespoons will be drawn, for DNA study.      Participants will undergo the following procedures and tests:        -  Physical examination.        -  Test of vital signs, lying and standing.        -  Electrocardiogram.        -  Collection of blood for chemistry and hematology.        -  Urinalysis.        -  HIV, urine drug, and hepatitis screening.        -  Psychiatric screening.        -  (SqrRoot) -HCG pregnancy test, if applicable.      At the second visit, patients will receive either tryptophan depletion or placebo, and 5     hours later, the study will begin, to last up to 2 additional hours. Patients will be asked     periodically about their emotional state or changes in their well-being. The MRI system will     create images of the brain's blood flow and measure glucose metabolism as a measure of brain     activity. During the MRI scan, patients will hear knocking or beeping sounds, and they will     wear earplugs to reduce the noise. Patients will be able to communicate with the MRI staff at     all times during the scan, and they may ask to be moved out of the machine at any time. The     MRI session lasts up to 1.5 hours.      Results of any medical tests or other information will not be provided to participants,     because further research may be needed before such results are meaningful. But if meaningful     information develops from this study that may be important for a participant's health, he or     she will be notified about it when it becomes available.   "
171933|NCT00090844|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect     normal ovarian cells from the side effects of chemotherapy.      PURPOSE: This randomized phase II trial is studying how well triptorelin works in preserving     ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast     cancer.   "
171934|NCT00090857|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. Letrozole may be effective in preventing the development     or recurrence of breast cancer in postmenopausal women who are at increased risk of     developing breast cancer because of elevated estradiol levels.      PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing     breast cancer in postmenopausal women with elevated estradiol levels.   "
171935|NCT00090870|"     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.     Colony-stimulating factors such as sargramostim may increase the number of immune cells found     in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping     blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with     sargramostim and thalidomide works in treating patients with metastatic kidney cancer.   "
172008|NCT00091975|"     The objective of this study is to determine the safety and efficacy of Zemplar® Capsule     versus placebo, in decreasing elevated intact parathyroid hormone levels in chronic kidney     disease stage 5 subjects with secondary hyperparathyroidism on hemodialysis or peritoneal     dialysis, while using the revised dose titration scheme.   "
171936|NCT00090896|"     RATIONALE: Biological therapies, such as CP-675,206, work in different ways to stimulate the     immune system and stop tumor cells from growing. Vaccines may make the body build an immune     response to kill tumor cells. Combining CP-675,206 with vaccine therapy may cause a stronger     immune response and kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of CP-675,206 when     given with vaccine therapy in treating patients with stage III or stage IV melanoma that     cannot be removed with surgery.   "
171937|NCT00090909|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and dexamethasone,     work in different ways to stop cancer cells from dividing so they stop growing or die.     Combining more than one drug may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together     with dexamethasone works in treating patients with relapsed or refractory Hodgkin's lymphoma.   "
171938|NCT00090961|"     RATIONALE: Pulmonary rehabilitation education and exercise training may improve physical     function and quality of life in patients who are receiving treatment for lung cancer.      PURPOSE: This randomized clinical trial is studying pulmonary rehabilitation education and     exercise training to see how well they work compared to exercise training alone in improving     physical function and quality of life in patients who are undergoing chemotherapy and     radiation therapy for locally advanced lung cancer.   "
171939|NCT00090974|"     RATIONALE: Quality-of-life assessment in postmenopausal women who are receiving hormone     therapy for breast cancer may help to determine the effects of treatment on these patients     and may improve the quality of life for future breast cancer patients.      PURPOSE: This clinical trial is studying quality of life of postmenopausal women who are     receiving either exemestane or anastrozole with or without celecoxib for stage I, stage II,     or stage IIIA primary breast cancer.   "
171940|NCT00090987|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes     necessary for their growth.      PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating     patients with HIV-related Kaposi's sarcoma.   "
171941|NCT00091026|"     This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how     well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with     advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can     locate tumor cells and either kill them or deliver tumor-killing substances to them without     harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways     to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth     of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and     gemcitabine with either cetuximab or erlotinib may kill more tumor cells.   "
171942|NCT00091039|"     RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune     response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin,     work in different ways to stop tumor cells from dividing so they stop growing or die.     Radiation therapy uses high energy x-rays to damage tumor cells. Combining vaccine therapy     with chemotherapy and radiation therapy may kill more tumor cells.      PURPOSE: This clinical trial is studying how well giving vaccine therapy together with     paclitaxel, carboplatin, and radiation therapy works in treating patients with stage III     non-small cell lung cancer that cannot be removed with surgery.   "
171943|NCT00091052|"     RATIONALE: Colony-stimulating factors such as sargramostim increase the number of immune     cells found in bone marrow or peripheral blood. Radiation therapy uses high-energy x-rays to     damage tumor cells. Combining radiation therapy with sargramostim may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects of giving radiation therapy     together with sargramostim and to see how well it works in treating patients with advanced     solid tumors.   "
171944|NCT00091078|"     Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Oblimersen may help imatinib mesylate kill more tumor cells by making tumor     cells more sensitive to the drug. This phase II trial is studying how well giving imatinib     mesylate together with oblimersen works in treating patients with advanced gastrointestinal     stromal tumor that cannot be removed by surgery.   "
171945|NCT00091091|"     RATIONALE: Assessing the long-term effects of cancer treatment in cancer survivors may help     improve the ability to plan effective treatment and follow-up care.      PURPOSE: This clinical trial is studying the long-term effects of treatment in patients who     were previously treated for childhood Hodgkin's lymphoma.   "
171946|NCT00091104|"     RATIONALE: Inserting a laboratory-treated gene into a person's white blood cells may make the     body build an immune response to kill tumor cells. Giving cyclophosphamide and fludarabine     before a white blood cell infusion may suppress the immune system and allow tumor cells to be     killed. Vaccines may make the body build an immune response to kill tumor cells. Aldesleukin     may stimulate a person's white blood cells to kill tumor cells. Combining white blood cell     infusion with vaccine therapy and aldesleukin may cause a stronger immune response and kill     more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of gene-modified white     blood cells when given together with cyclophosphamide, fludarabine, vaccine therapy, and     aldesleukin and to see how well it works in treating patients with metastatic melanoma.   "
171947|NCT00091117|"     Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their     growth. This phase I trial is studying the side effects and best dose of bortezomib in     treating patients with advanced cancer and liver dysfunction.   "
171948|NCT00091130|"     This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a     placebo in treating human papillomavirus and preventing cervical cancer in patients with     abnormal cervical cells. Vaccines, such as SGN-00101, may make the body build an immune     response to kill human papillomavirus and abnormal cervical cells and may be effective in     preventing cervical cancer   "
172009|NCT00091988|"     PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized,     controlled trial.   "
172010|NCT00092001|"     The purpose of this study is to test whether SU011248 has activity and is safe in patients     with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing     regimen and docetaxel.   "
174016|NCT00120328|"     The purpose of this study is to determine whether avosentan (SPP301) is effective in     decreasing morbidity and mortality in patients with diabetic nephropathy.   "
171949|NCT00091143|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop     tumor cells from dividing so they stop growing or die. Vaccines made from peptides may make     the body build an immune response to kill tumor cells. Infusions of a person's white blood     cells may be able to replace immune cells that were destroyed by chemotherapy. Combining     fludarabine with vaccine therapy and white blood cell infusions may kill more tumor cells.      PURPOSE: This randomized phase I trial is studying the side effects of giving vaccine therapy     together with fludarabine and white blood cell infusions and to see how well it works in     treating patients with unresectable or metastatic melanoma.   "
171950|NCT00091156|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. It is not yet known whether giving gefitinib after initial chemotherapy is     effective in delaying the recurrence of non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works     compared to placebo in delaying tumor recurrence in patients who have undergone initial     chemotherapy for stage IIIB or stage IV non-small cell lung cancer.   "
171951|NCT00091169|"     RATIONALE: Levocarnitine may help improve energy levels in cancer patients.      PURPOSE: This randomized phase III trial is studying how well levocarnitine works compared to     a placebo in treating fatigue in cancer patients.   "
171952|NCT00091182|"     This phase II trial is studying how well oxaliplatin works in treating young patients with     recurrent solid tumors that have not responded to previous treatment. Drugs used in     chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing     so they stop growing or die.   "
171953|NCT00091195|"     This phase II trial is studying how well depsipeptide (romidepsin) works in treating patients     with recurrent ovarian epithelial or peritoneal cavity cancer. Drugs used in chemotherapy,     such as depsipeptide (romidepsin), work in different ways to stop tumor cells from dividing     so they stop growing or die. Depsipeptide (romidepsin) may also stop the growth of ovarian     epithelial or peritoneal cavity cancer by stopping blood flow to the tumor and by blocking     the enzymes necessary for their growth   "
171954|NCT00091234|"     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.     It is not yet known whether gemtuzumab ozogamicin is more effective than standard supportive     care in treating older patients who have acute myeloid leukemia.      PURPOSE: This randomized phase II/III trial is studying two different gemtuzumab ozogamicin     regimens to see how well they work compared to standard supportive care in treating older     patients with previously untreated acute myeloid leukemia.   "
171955|NCT00091247|"     RATIONALE: Tetracycline may be effective in preventing skin rash that is caused by treatment     with drugs such as gefitinib or cetuximab.      PURPOSE: This randomized clinical trial is studying tetracycline to see how well it works     compared to placebo in preventing skin rash in patients who are receiving drugs such as     gefitinib or cetuximab for cancer.   "
171956|NCT00091260|"     RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary     systemic amyloidosis.      PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without     dexamethasone in treating patients with primary systemic amyloidosis.   "
171957|NCT00091273|"     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill     tumor cells.      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating     patients with ovarian epithelial or primary peritoneal cancer.   "
171958|NCT00091286|"     RATIONALE: Vaccines made from peptides may make the body build an immune response to kill     tumor cells.      PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients     with stage IIB, stage III, or stage IV colorectal cancer.   "
171959|NCT00091299|"     RATIONALE: Vatalanib may stop the growth of tumor cells by stopping blood flow to the tumor.     Warfarin may be effective in preventing the formation of blood clots in patients who are     undergoing treatment for advanced solid tumors.      PURPOSE: This phase I trial is studying how well giving warfarin together with vatalanib     works in treating patients with advanced solid tumors.   "
171960|NCT00091312|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work     in different ways to stop tumor cells from dividing so they stop growing or die. Combining     more than one drug and giving them after surgery may kill any remaining tumor cells. It is     not yet known whether combination chemotherapy is more effective than observation alone in     treating patients who have undergone surgery for colon cancer.      PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or     without leucovorin to see how well they work compared to observation alone in treating     patients who have undergone surgery for stage II colon cancer.   "
171961|NCT00091325|"     RATIONALE: Green tea extract (Polyphenon E) contains ingredients that may prevent the     development of cancer.      PURPOSE: This phase I trial is studying how well green tea extract works in preventing cancer     in healthy participants.   "
171962|NCT00091338|"     RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells.     Vaccines made from peptides may make the body build an immune response to kill tumor cells.     Combining interleukin-7 with vaccine therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 when     given with vaccine therapy in treating patients with metastatic melanoma.   "
171963|NCT00091351|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation     therapy before surgery may shrink the tumor so that it can be removed. It is not yet known     whether surgery is more effective with or without radiation therapy.      PURPOSE: This randomized phase III trial is studying surgery alone to see how well it works     compared to radiation therapy together with surgery in treating patients with primary soft     tissue sarcoma of the retroperitoneum or pelvis.   "
172011|NCT00092014|"     This study is to evaluate and compare the effects of Alendronate and Risedronate to treat     women with postmenopausal osteoporosis. The primary hypothesis for this study is that in     postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly     will produce a mean percent increase from baseline in hip trochanter bone mineral density     (BMD) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg     once weekly.   "
172012|NCT00092027|"     This study is to assess the safety and tolerability of MK0217 being evaluated to treat women     with postmenopausal osteoporosis.   "
171964|NCT00091377|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different     ways to stop tumor cells from dividing so they stop growing or die. Phenoxodiol may help     cisplatin and paclitaxel kill more tumor cells by making tumor cells more sensitive to the     drugs.      PURPOSE: This randomized phase I/II trial is studying the side effects of phenoxodiol when     given together with either cisplatin or paclitaxel and to see how well they work in treating     patients with recurrent late-stage ovarian epithelial cancer, fallopian tube cancer, or     primary peritoneal cancer that has not responded to treatment with drugs such as paclitaxel,     docetaxel, cisplatin, or carboplatin.   "
171965|NCT00091390|"     RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells.     Internal radiation therapy uses radioactive material placed directly into or near a tumor to     kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving internal radiation therapy together     with external-beam radiation therapy works in treating patients with stage II or stage III     prostate cancer.   "
171966|NCT00091416|"     The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine,     VRC-HIVADV014-00-VP, when given as a vaccine booster to HIV uninfected adults who     participated in HVTN 052.   "
171967|NCT00091429|"     The study will be a multi-national, double-blind, randomized, placebo-controlled, parallel     group study to evaluate the effectiveness of ranolazine (1000 mg twice daily) in     approximately 500 patients with chronic angina who remain symptomatic despite daily treatment     with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved     for the treatment of chronic angina. Eligible patients will be randomized to receive     ranolazine 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of     amlodipine. Participation in the study will last approximately 3 months.   "
171968|NCT00091442|"     The purpose of the study is to evaluate whether the time to progression for the DOXIL and     docetaxel combination therapy group was superior to that of the group treated with docetaxel     monotherapy in participants with advanced breast cancer.   "
171969|NCT00091468|"     The purpose of this 12-month study is to determine whether nicotine, administered in the form     of nicotine patches, can improve symptoms of memory loss in some people experiencing mild     memory problems (referred to in this study as mild cognitive impairment or MCI).   "
171970|NCT00091481|"     To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between     two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline     iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).   "
171971|NCT00091494|"     To investigate how inflammation, hemostasis, and stress may contribute to neighborhood and     individual-level socioeconomic differences in cardiovascular risk.   "
171972|NCT00091507|"     The purpose of this study is to test the impact of pharmacological myocardial metabolic     support, in the form of intravenous (IV) glucose, insulin and potassium (GIK), for the     treatment of patients with threatened or established acute myocardial infarction (AMI).   "
171973|NCT00091520|"     The purpose of this study is to evaluate the efficacy and safety of Nesiritide administered     as serial infusions to heart failure (HF) patients in the outpatient setting.   "
171974|NCT00091533|"     This study will examine activity in the brain during the observation of touch. Studies with     animals have shown that mirror neurons, or nerve cells, are active during the observation and     performance of an action. The researchers for this study hypothesize that a similar system     pertains to observing and experiencing touch.      Patients ages 18 to 75 years old who are in good health, are right handed, and who are able     to perform simple tasks that require attention may be eligible for this study. Pregnant women     are not eligible.      Patients who have not had a health screening at NIH will undergo a clinical and neurological     exam. Women of childbearing potential will also have a pregnancy test. The screening will     take about 2 to 3 hours. A diagnostic magnetic resonance imaging (MRI) scan will be performed     if patients have not undergone one in the previous 12 months. During the procedure, patients     will lie still on a table that will slide into the enclosed tunnel of the scanner. They will     be asked to lie as still as possible for up to a few minutes at a time. As the scanner takes     pictures, patients will hear knocking or beeping sounds, and they will wear earplugs to     reduce the noise. Patients will be able to communicate with the MRI staff at all times during     the scan, and they may ask to be moved out of the machine at any time. This scan will take     about 2 hours.      Two sessions are involved in the study. The first one is intended to familiarize patients     with the procedure. During it, they will learn about hand stimulus, through watching a video     showing the index finger of a hand being touched by a stick repeatedly. Then the activity     will be repeated, but this time, a researcher will also touch the patient's index finger     while he or she is watching the video. This session will take about 1 hour.      The second session consists of a functional MRI scan, or fMRI. During it, pictures of the     brain will be taken while patients perform tasks. All tasks will be explained in advance, and     patients will have an opportunity to practice them before entering the scanner. The fMRI scan     will take 1 to 2 hours.      The researchers will discuss the results of the tests with the participants. There is not a     direct benefit to those who take part in the study. However, it is hoped that resulting     information will enhance researchers' understanding about how the brain processes observed     information.   "
171975|NCT00091546|"     The goal of this study is to identify the modifying genes and environmental features that     regulate the clinical expression of mutations in bone morphogenetic protein receptor 2     (BMPR2); to develop the understanding of how BMPR2 mutations result in disease; and to     identify the undiscovered genetic mutations that cause primary pulmonary hypertension (PPH).   "
171976|NCT00091559|"     A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher)     who have progressive, persistent, or recurrent disease on or following 2 other therapies, one     of which must have contained Targretin (bexarotene)or for patients who are not candidates or     could not tolerate Targretin therapy.   "
171977|NCT00091572|"     The purpose of this study is to ascertain if the extended schedule of Temozolomide, which     allows increased doses and potential depletion of the enzyme underlaying resistance, is a     more effective treatment of metastatic melanoma than single agent dacarbazine.   "
171978|NCT00091585|"     The purpose of this study is to determine whether SNS-595 given intravenously once every 3     weeks is safe.   "
171979|NCT00091598|"     The primary objective is to determine the effect of ambrisentan on exercise capacity in     subjects with PAH.   "
171998|NCT00091845|"     Although the serious form of West Nile Virus (WNV) disease, referred to as neuroinvasive     disease, is rare, it can result in permanent disabilities and occasionally death. For     patients who get this serious form of WNV disease, there are no approved specific treatment     options.      The purpose of this study is to test a new drug, AVI-4020 Injection, in patients who are     hospitalized with recent symptoms of this form of WNV disease. In this study, we will     determine if the AVI-4020 treatment is safe. This will be accomplished by reviewing the     results of laboratory tests and clinical signs and symptoms. Additionally, we will review the     patient data for signs that AVI-4020 is providing any beneficial effects against WNV     neuroinvasive disease.   "
171980|NCT00091611|"     Background:        -  Some patients with advanced kidney cancer have immune cells that can recognize and kill          their cancer, but the cells are not active enough or numerous enough to accomplish this          on their own.        -  In recent studies of patients with advanced melanoma, some patients given special          tumor-fighting cells (cells taken from the patient's tumor cells and grown in the          laboratory) showed some anti-tumor response.      Objectives:      -To determine whether special tumor-fighting cells taken from the patient's blood or tumor     and grown in the laboratory can cause tumors in patients with kidney cancer to shrink when     they are given back to the patient along with interleukin-2.      Eligibility: Patients 18 years of age or older with advanced kidney cancer.      Design:        -  Up to 29 patients will be treated in this study.        -  Patients undergo tumor biopsy to collect tumor cells for creating special tumor-fighting          cells for later infusion.        -  Patients undergo apheresis to collect stem cells for later re-infusion. For apheresis,          whole blood is collected through a needle in an arm vein and circulated through a          cell-separating machine where the stem cells are extracted. The rest of the blood is          returned through the same needle or a needle in the other arm.        -  Before receiving the treated white cells, patients are given two drugs to suppress the          immune system so the treated cells can work without interference from immune system          cells. They are given cyclophosphamide over 2 days through a catheter (plastic tube          inserted into a vein in the arm or neck) and fludarabine through the catheter over 15-30          minutes for the next 5 days.        -  The day after the last dose of fludarabine, the tumor-fighting cells are infused through          a vein over 10-20 minutes.        -  Following the cell infusion, patients start treatment with high-dose interleukin-2 every          8 hours for a maximum of 12 doses.        -  Patients are evaluated with x-ray studies about 1 month after receiving the cells and          interleukin 2 (IL-2) to look for tumor response to treatment. Those who show significant          improvement continue to receive treatment until the treated cells are used up or the          patient no longer benefits or develops unacceptable side effects.   "
171981|NCT00091624|"     A Phase I Study of CC-5013 in combination with Doxil, Vincristine and Decadron (DVd) in     Subjects with Relapsed or Refractory Multiple Myeloma   "
171982|NCT00091637|"     In the setting of reperfusion therapy in an acute myocardial infarction using primary     percutaneous intervention (PCI), the body's own inflammatory system involving the complement     cascade may be harmful. This study will test the safety and efficacy of a novel complement     inhibitor, pexelizumab to reduce mortality at 30 days.   "
171983|NCT00091650|"     The goals of this study are to determine: the safety of olanzapine and any side effects that     might be associated with it, how olanzapine compares to placebo, whether olanzapine can help     patients with symptoms of Borderline Personality Disorder (BPD), and how much olanzapine     should be given to patients.   "
171984|NCT00091663|"     This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with     advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard     chemotherapy treatment.   "
171985|NCT00091676|"     The primary objective of this Phase 3 study is to definitively confirm the safety and     efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as     measured by a significant prolongation of the period of disease free survival when     administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their     first complete remission.   "
171986|NCT00091689|"     Study 1501-852A is a Phase 1 Study with the objective of determining safety and the highest     tolerated dose of an immune response modifier cream directly applied to advanced, inoperable,     melanoma skin lesions. The study will also measure blood levels of the drug and examine the     potential anti-tumor activity of the cream.   "
171987|NCT00091702|"     The purpose of this study is to compare two flu vaccines to determine their safety and     ability to stimulate an immune response in HIV infected children and adolescents. This study     will also determine how often and how long people who receive a vaccine are able to spread     flu vaccine virus to other people.   "
171988|NCT00091715|"     The present trial investigates a possible use of oral bosentan, which is currently approved     for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to     patients suffering from PAH Class II.   "
171989|NCT00091728|"     There are biological reasons to suspect that hormones may affect the risk of a woman becoming     infected with a sexually transmitted disease. The evidence on this issue to date is mixed and     previous studies have methodologic flaws making it difficult to draw conclusions about the     results.      This study compares the risk of developing either Chlamydial or Gonorrheal infection among     three groups of women: those using combined oral contraceptives (birth control pills); those     using the injectable hormone (brand name Depo Provera); and those women using non-hormonal     contraceptive methods.   "
171990|NCT00091741|"     The purpose of conducting this already-FDA approved Phase I clinical trial is to evaluate the     safety and efficacy of etanercept (Enbrel) on the response rate in HIV-infected subjects who     have failed to respond to conventional antiretroviral (HAART) therapy and for whom no     alternative therapy exists. The greatest challenge faced by HIV-treating clinicians today is     the management of virologic failure and metabolic complications of anti-HIV treatment.     Treatment failure can occur because of non-compliance, drug discontinuation, lack of drug     potency, inadequate drug plasma concentration or drug resistance. Of these, drug resistance     remains the single most important reason for virological failure and rapidly limits treatment     options.   "
171991|NCT00091754|"     To identify new cellular, metabolic, and genomic correlates of atherosclerotic plaque and     early pathologic changes in the vascular wall and determine their consequences for coronary     heart disease and stroke.   "
171992|NCT00091767|"     To investigate genetic factors that affect asthma severity.   "
171993|NCT00091780|"     To test the hypothesis that breast arterial calcification (BAC) seen on mammograms can     identify women with an increased risk of coronary artery disease (CAD).   "
171994|NCT00091793|"     This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss     in both early and late postmenopausal women with osteopenia, and to further test the safety     and tolerability of AMG 162 in this population.   "
171995|NCT00091806|"     The purpose of this study is to evaluate the safety and pharmacokinetics of two dose     schedules of panitumumab in subjects with advanced solid tumors.   "
171996|NCT00091819|"     Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and     an approved drug, vancomycin, for the treatment of complicated skin and skin structure     infections.   "
171997|NCT00091832|"     This study is to evaluate various doses and schedules for denosumab administration and     characterize the safety profile in this indication.   "
171999|NCT00091858|"     The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in     reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who     are not receiving chemotherapy.   "
172013|NCT00092040|"     The purpose of this study and 12 month extension is to evaluate the effects of two     investigational drugs on osteoporosis in postmenopausal women.   "
172000|NCT00091871|"     Eosinophils are a type of white blood cell. Elevated eosinophil levels can damage the heart,     nerves, and other organs, in the syndrome known as hypereosinophilic syndrome (HES). Some     individuals have a hereditary form of HES known as familial eosinophilia (FE). More research     on the causation and mechanisms of HES is needed in order to design more effective and less     toxic therapies.      This study will investigate FE and its genetic causes, damage mechanisms, and disease markers     (such as blood test abnormalities). It will enroll approximately 20 individuals (both adults     and children) from a previously studied family with FE. This is a long-term study of     indefinite duration.      Participants will undergo yearly clinical examinations including medical history, physical     examination, bloodwork, EKG, echocardiogram, and pulmonary function tests, with additional or     more frequent examinations and tests as required. In addition, participants will donate blood     and tissue for research purposes. Both adult and child participants will donate blood. At the     initial evaluation, adult participants will donate bone marrow. During the study, some adult     participants will also undergo a limited number of leukaopheresis sessions, in which blood is     donated from one arm, the blood is separated into red blood cells and other components, and     the red blood cells are returned into the donor's other arm.   "
172074|NCT00092872|"     This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational     drug in obese patients after a very low calorie diet.   "
172001|NCT00091884|"     Some patients with HIV/AIDS suffer from a dangerous viral infection of the retina (and other     organs) called cytomegalovirus infection (CMV). The medications currently used to treat CMV     all have serious side effects. AIDS patients are prone to this infection because their immune     system produces a lower number of CD4+T lymphocytes, the type of blood cells that fight viral     infections.      Some new HIV medications strengthen the immune system. This study will investigate the     possibility that CMV patients on these HIV medications can develop immune systems strong     enough to fight CMV without CMV medication. The study will enroll a maximum of 15 adult     HIV/AIDS patients who have a CD4+T cell count over 150 cells/microliter and who have inactive     CMV retinitis that is not immediately sight threatening. It is expected to last approximately     2 years.      Each prospective participant will have a physical examination and complete eye examination,     including retina photographs, with the eye examination and retina photographs repeated 2     weeks later. If there is no evidence of active CMV retinitis, the participant will be     enrolled in the study, and CMV medication will be stopped. The participant will have physical     and eye examinations every 2 weeks for the first 3 months of the study, and every 3 weeks for     the next 3 months. After 6 months, the frequency of the examinations will be 2-8 weeks,     depending on the participant's CD4 count. After one year, a participant with a CD4 count     remaining over 150 cells/microliter may return to the care of a local ophthalmologist with     HIV/CMV experience, revisiting the clinical center every 6 months. The participant's CMV     medication will be restarted when CMV retinitis becomes active, which will terminate     participation in the study.   "
172002|NCT00091897|"     This study will test whether rituximab (RITUXAN (Trademark)) can relieve symptoms of stiff     person syndrome (SPS), a progressive disease that causes stiffness of the muscles and muscle     spasms induced by unexpected noises, touches, or stressful events. People with SPS may have     certain proteins in their blood called anti-GAD antibodies that may cause some of the     symptoms of the disease. Rituximab, a drug approved to treat lymphomas, targets certain white     blood cells that produce antibodies. This study will see if rituximab can also be effective     in patients with SPS who have high anti-GAD antibodies.      Patients between 25 and 80 years of age with SPS may be eligible for this study. Candidates     are screened with a medical history, physical examination, and blood tests. Participants     undergo the following tests and procedures:        -  Rituximab or placebo treatment: Patients are randomly assigned to receive two infusions          by vein of either rituximab or placebo (a look-alike solution with no active ingredient)          2 weeks apart. The infusions last from 3 to 4 hours, but may take as long as 16 hours if          the rate must be slowed for any reason. Patients are followed monthly for up to 6 months          and then every 2 months for up to 1 year after treatment.        -  Medical history and interview, physical and neurological examinations: Patients are          questioned about their vaccination history, medical, surgical, and psychiatric history,          exposure to environmental toxins or viruses, and family and social history, including          habits and employment.        -  Blood drawing: Blood samples are collected before the two infusions and at all follow-up          visits.        -  Apheresis: For this procedure, which is used to collect white blood cells, blood is          collected through a needle in an arm vein, similar to donating blood. The blood flows          from the vein through a catheter (plastic tube) into a machine that separates it into          its components by centrifugation (spinning). The white cells are removed and the rest of          the blood (red cells, plasma and platelets) is returned to the body through a second          needle in the other arm. The procedure takes about 60 to 90 minutes.        -  Lumbar puncture (spinal tap): Lumbar puncture is done to sample a small amount of          cerebrospinal fluid (CSF, the fluid that bathes the brain and spinal cord), for          analysis. For this procedure, the patient is given a local anesthetic and a needle is          inserted into the space between the bones in the lower back where the CSF circulates          below the spinal cord. A small amount of fluid is withdrawn through the needle.   "
172003|NCT00091910|"     Erythropoietin (EPO) is a hormone produced in the kidney. Its function is to stimulate the     production of red cells in the bone marrow. The purpose of this research study is to     demonstrate that the administration EPO to critically ill subjects in the intensive care unit     (ICU) reduces the number of patients requiring red blood cell (RBC) transfusion as compared     with placebo (a liquid without active medicine).   "
172004|NCT00091923|"     The objectives of the Spectacle Phase are:        -  In previously untreated pure anisometropic patients (i.e. patients who have not used          spectacles in the last year and who do not have strabismus), to determine             1. the incidence of resolution of amblyopia with spectacle correction alone and             2. the time course of visual acuity improvement with spectacle correction alone.        -  In all other patients, to achieve maximal improvement with spectacle correction prior to          entering the randomized trial.      The objectives of the Randomized Trial are:        -  To determine whether 5 weeks of patching treatment (2 hours of patching per day of the          sound eye combined with at least one concurrent hour of near activities), compared with          a control group (using spectacle correction only), improves visual acuity in patients          with moderate to severe amblyopia (20/40 to 20/400).        -  To determine the maximal improvement and time course of improvement with this patching          treatment regimen.   "
172005|NCT00091936|"     Tuberculosis (TB), a bacterial infection common in HIV infected people, is a major problem in     developing countries. The purpose of this study is to test the effectiveness of a combined     treatment strategy using directly observed therapy (DOT) for HIV infected patients with TB.     Participants will be recruited from resource-poor communities in Durban, South Africa.   "
172006|NCT00091949|"     The purpose of this study is to determine if pioglitazone is effective in preventing future     strokes or heart attacks among non-diabetic persons who have had a recent ischemic stroke.   "
172007|NCT00091962|"     The purpose of this study is to treat depression in patients who have undergone coronary     artery bypass graft (CABG).   "
172037|NCT00092378|"     This purpose of this study is to compare the safety and effectiveness of two approved drugs     in the treatment of pain following bunionectomy surgery.   "
172014|NCT00092053|"     The purpose of this study is to evaluate the efficacy and safety of an investigational drug     in postmenopausal women with osteoporosis. The primary hypothesis of this study is that in     postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150     mg, does not achieve persistence in reduction of bone resorption throughout the monthly     dosing interval, as demonstrated by a larger change in the serum carboxyterminal crosslinked     telopeptide of Type I collagen (CTX-I) log-transformed fraction from baseline four weeks post     dose compared to one week post dose, during the third month of treatment, in the participants     taking ibandronate than in the participants taking placebo.   "
172015|NCT00092066|"     The purpose of this study is to test the safety, tolerability and effectiveness of an     investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and     deficiency during the treatment of osteoporosis in men and postmenopausal women.   "
172016|NCT00092079|"     The purpose of this study is to test the safety, tolerability, and effectiveness of an     investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and     deficiency during treatment of osteoporosis in men and postmenopausal women.   "
172017|NCT00092092|"     The purpose of this study is to determine the effect of montelukast, an approved medication,     on the lower leg growth rate in children with mild asthma. The primary hypothesis is that the     lower leg length (LLL) growth rate for children treated with montelukast compared to placebo     will be established.   "
172018|NCT00092105|"     The purpose of this study is to determine the protective effect of an approved medication on     asthma and allergic rhinitis (inflammation of the mucous membrane of the nose) upon exposure     to cats.   "
172019|NCT00092118|"     The purpose of this study is to determine the effect of an approved medication on the     symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose     similar to that found in hay fever except that symptoms persist throughout the year), in     patients who have a history of perennial allergic rhinitis.   "
172020|NCT00092131|"     The purpose of this study is to determine the effect of an approved medication being studied     in support of a new approach in the prevention of exercise-induced asthma (a worsening of     asthma caused by exercise, also known as exercise-induced bronchospasm), in participants who     have a history of worsening asthma after exercise.   "
172021|NCT00092144|"     The purpose of this study is to assess the efficacy and safety of an approved drug on asthma     symptoms in patients with chronic asthma which is also active during the allergy season.   "
172022|NCT00092157|"     The purpose of this study is to evaluate the safety and effectiveness of two approved drugs     in lowering high cholesterol when taken together, compared to taking only one of the drugs.   "
172023|NCT00092170|"     The purpose of this study is to determine the effect of an approved medication for adults for     an investigational use in pediatric patients 3 months to 17 years for the treatment of     complicated intra-abdominal infections or acute pelvic infections.   "
172024|NCT00092183|"     This protocol will study an investigational drug treatment plan against standard therapy in     the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast     cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic     chemotherapy.   "
172025|NCT00092196|"     The purpose of this study is to determine the efficacy and tolerability of an investigational     drug for the prevention of chemotherapy-induced nausea and vomiting associated with     moderately emetogenic chemotherapy.   "
172026|NCT00092209|"     The purpose of this study is to evaluate antihypertensive (lowering blood pressure)     effectiveness of three combinations of approved study drugs compared to both study drugs     being given alone.   "
172027|NCT00092222|"     This study will gain information about a rare disorder called KSHV-associated multicentric     Castleman s disease (MCD). KSHV, a virus, causes several kinds of cancer, including some     forms of MCD. KSHV stands for the Kaposi s sarcoma herpes virus, also called human herpes     virus-8, or HHV-8. Researchers want to understand the biology of KSHV-MCD to identify how     this disease causes illness and to find ways to treat it. There is no standard therapy     effective for all cases of KSHV-MCD. The disease is often fatal, and about half the people     who have it die within 2 years of diagnosis.      Patients ages 12 and older may be eligible for this study. Participation entails more drawing     of blood and having repeated tumor biopsies than if patients received treatment in a     non-research setting. Researchers would like to learn more about the relationship of KSHV and     Castleman s disease symptoms, and they want to obtain at least three biopsies in this study.      There are some side effects of experimental therapy that patients may take for KSHV-MCD.     Zidovudine, or Retrovir , is used at a high dose. It is given orally or through a vein, four     times daily, for 7 days or longer. Zidovudine can cause nausea, vomiting, decreased bone     marrow function, and decreased blood counts. Combined with valganciclovir, or Valcyte , it is     likely to be more toxic to bone marrow. Valganciclovir can cause problems with bone marrow     function, leading to low blood counts, sterility, and defects in a fetus. Combined with     zidovudine, valganciclovir may cause more toxicity to the bone marrow. It is given twice     daily for 7 days or longer. Bortezomib, or Velcade , is given for a few seconds by a rapid     push through a needle into the vein. It is given twice weekly for four doses and then stopped     for 1 week. Bortezomib can sometimes cause low blood pressure; it also can cause     gastrointestinal problems and a low blood platelet count. Rituximab and liposomal doxorubicin     are drugs given by a catheter into a vein. Interferon-alpha is given by injection into the     skin. Those drugs are not experimental, but their use in Castleman s disease is experimental.      Some patients may be treated with a combination of chemotherapy followed by interferon-alpha.     Interferon-alpha is infected into the skin by a needle. The natural form of interferon is     produced by the body and helps to control viral infections. KSHV decreases the effect of the     body s interferon, and the researchers want to see if giving higher doses of interferon will     help to control KSHV infection.      A positron emission tomography (PET) scan, for research purposes only, may be done up to     three times a year. A radioactive sugar molecule called fluorodeoxyglucose, or FDG, is used.     It is believed that activated lymphocytes that may be found in patients disease might use     more FDG because these cells burn more glucose fuel. Children younger than 18 years will not     have PET scan done.      This study may or may not have a direct benefit for participants. However, detailed     assessments made throughout the study may provide information to help the doctors treat     KSHV-MCD better.   "
172028|NCT00092235|"     Background:        -  Chronic graft-versus-host disease (cGVHD) is a multi-organ alloimmune and autoimmune          disorder that occurs following allogeneic hematopoietic stem cell transplantation          (alloHSCT). It is characterized by immune dysregulation, immunodeficiency, impaired          organ function, and decreased survival.        -  Each year about 7000 patients receive allogeneic hematopoietic stem cell transplant          (alloHSCT) in North America and about 50% of patients who are transplanted develop          cGVHD.        -  Chronic GVHD is also a disorder that simultaneously affects many organ systems in highly          variable fashion and requires complex and coordinated medical management by multiple          medical specialties. There is an urgent need for progress in understanding and effective          treatments for cGVHD as it is one of the most serious complications of cancer therapy          and hematopoietic stem cell transplantation.      Objectives:        -  To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and          natural history of cGVHD.        -  To prospectively identify clinical and biological prognostic markers in patients with          cGVHD.        -  To develop clinically relevant cGVHD grading scales.        -  To identify novel biological characteristics of cGVHD and to describe them in the          context of clinical history and presentation.        -  To identify potential clinical and biological markers of cGVHD activity.        -  To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects.      Eligibility:      -Patients age 1-75 referred by the primary transplant physician for the evaluation of chronic     graft-versus-host disease independent of underlying diagnosis.      Design:        -  Patient undergoes initial clinical and labotory multispecialty work-up at the NCI cGVHD          clinic.        -  Minimally invasive biopsies and rarely, deep tissue biopsy may be obtained to confirm          the diagnosis and/or rule-out other pathologic process (in adults only).        -  Long tem data collection for evaluation of long-term outcomes will be conducted every          six months during the first three years of the study and then yearly.   "
172029|NCT00092274|"     The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a     treatment for Follicular Lymphoma (FL).   "
172030|NCT00092287|"     The aim of this study is to compare the efficacy and safety of lanreotide Autogel and     Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce     a similar clinical response in patients with carcinoid syndrome.   "
172031|NCT00092300|"     The purpose of this study is to compare the safety and effectiveness of two approved drugs in     the treatment of pain following dental surgery.   "
172032|NCT00092313|"     The purpose of this study is to compare the safety and effectiveness of two approved drugs in     the treatment of pain following dental surgery.   "
172033|NCT00092326|"     The purpose of this study is to compare the safety and effectiveness of two approved drugs in     the treatment of pain following dental surgery.   "
172034|NCT00092339|"     The purpose of this study is to compare the safety and effectiveness of two approved drugs in     the treatment of pain following dental surgery.   "
172035|NCT00092352|"     The purpose of this study is to compare the safety and effectiveness of two approved drugs in     the treatment of osteoarthritis of the knee.   "
172036|NCT00092365|"     The purpose of this study is to compare the safety and effectiveness of two approved drugs in     the treatment of osteoarthritis of the knee.   "
172039|NCT00092404|"     The purpose of this trial is to study the safety and immune response to measles, mumps, and     rubella in children who were vaccinated with an investigational measles-mumps-rubella live     vaccine made with artificially made human protein.   "
172040|NCT00092417|"     This study compared the safety and tolerability profile of a higher potency investigational     vaccine to that of the investigational vaccine at a lower potency dose.   "
172041|NCT00092430|"     The purpose of this study is to demonstrate that an investigational refrigerated vaccine with     measles, mumps, rubella, and varicella is well tolerated and has similar immune response when     compared to a frozen vaccine with measles, mumps, rubella, and varicella.   "
172042|NCT00092443|"     This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and     the efficacy to prevent Rotavirus Gastroenteritis.   "
172043|NCT00092456|"     This study was designed to evaluate consistency in the antibody response to three     manufactured lots of an investigational Rotavirus Vaccine.   "
173713|NCT00107757|"     The purpose of this study is to determine if the investigational drug is effective and safe     in children with seasonal allergic rhinitis.   "
172044|NCT00092469|"     The purpose of this study is to evaluate the safety, tolerability, and immune response of an     investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis,     tetanus, hepatitis B, poliomyelitis, and Haemophilus influenza type b.   "
172045|NCT00092482|"     The purpose of the study is to determine if an investigational vaccine with a single     component develops an immune response that is similar to the equivalent investigational     vaccine with four components to reduce cervical disease.   "
172046|NCT00092495|"     The primary purpose of the study is to determine if an investigational vaccine Gardasil     (V501) with 4 components will provide an immune response and will be well tolerated in     pre-adolescents and adolescents.   "
172047|NCT00092508|"     This dose comparison study, taking place at over 200 sites worldwide, will compare the     dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and     efficacy of Asacol ® in the maintenance of remission in subjects with ulcerative colitis.   "
172048|NCT00092521|"     The primary purpose of the study is to determine if GARDASIL (V501) with four components is     able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial     Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.   "
172049|NCT00092534|"     The primary purpose of the study is to determine if Gardasil (V501) an investigational     vaccine with 4 components is able to prevent cervical cancer.   "
172050|NCT00092547|"     This study is to evaluate the safety, tolerability, and immune response of an investigational     vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma     Virus (HPV).   "
172051|NCT00092560|"     The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of     two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high     triglycerides).   "
172052|NCT00092573|"     The purpose of this study is to assess the cholesterol lowering safety and effectiveness of     two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high     triglycerides).   "
172053|NCT00092586|"     The purpose of this 6-week study is to compare the reduction in specific levels of     cholesterol in patients with high cholesterol.   "
172054|NCT00092599|"     This study will evaluate patients who have coronary heart disease to determine if an     investigational drug will further lower cholesterol when taken in combination with an     approved cholesterol lowering medication.   "
172055|NCT00092612|"     The purpose of this study is to investigate additional cholesterol lowering effects in     patients with coronary heart disease by giving an investigational drug with a patient's     current approved cholesterol lowering medication.   "
172056|NCT00092625|"     The purpose of this study is to investigate additional cholesterol lowering effects in     patients with coronary heart disease by giving an investigational drug with a patient's     current approved cholesterol lowering medication.   "
172057|NCT00092638|"     The purpose of this study is to investigate additional cholesterol lowering effects in     patients with coronary heart disease by giving an investigational drug with a patient's     current approved cholesterol lowering medication.   "
172058|NCT00092651|"     The purpose of this study is to evaluate the lipid lowering effects of an investigational     drug in patients with hypercholesterolemia (high cholesterol).   "
172059|NCT00092664|"     The purpose of this study is to evaluate the lipid lowering effects of an investigational     drug in patients with hypercholesterolemia (high cholesterol).   "
172060|NCT00092677|"     The purpose of this study is to evaluate whether treatment with an investigational drug as     compared to placebo will reduce the risk of major cardiovascular events in patients with     aortic stenosis.   "
172061|NCT00092690|"     This study is to assess the safety and efficacy of an investigational drug as compared to an     approved drug to reduce specific cholesterol levels.   "
172062|NCT00092703|"     The purpose of this study is to compare the gastrointestinal tolerability of an     investigational drug to an approved drug in the treatment of osteoarthritis during one year     treatment period.   "
172063|NCT00092716|"     The purpose of this study is to determine whether an investigational medication will be more     effective than an approved medication in reducing cholesterol levels.   "
172064|NCT00092729|"     The purpose of this study is to evaluate the pain relieving effect and safety of an     investigational drug in women with moderate to severe primary dysmenorrhea (painful     menstruation).   "
172065|NCT00092742|"     The purpose of this study is to evaluate the long-term safety of an investigational drug     versus an approved drug for the relief of pain in patients with rheumatoid arthritis.   "
172066|NCT00092755|"     This study was conducted to assess the safety and tolerability of an investigational drug and     to evaluate its effectiveness in the treatment of osteoarthritis of the hip or knee in both     men and women.   "
172067|NCT00092768|"     The purpose of this study is to compare the safety and effectiveness of an investigational     drug and an approved drug in the treatment of osteoarthritis of the knee and hip.   "
172068|NCT00092781|"     The purpose of this study is to compare the safety and effectiveness of an investigational     drug and an approved drug in the treatment of osteoarthritis of the knee and hip.   "
172069|NCT00092807|"     This is an extension study for patients having unusually high absorption of non-cholesterol     sterols, resulting in heart-related diseases. This study will evaluate the long term safety     and the ability to lower cholesterol levels with an investigational drug.   "
172070|NCT00092820|"     This is an extension study for patients having unusually high absorption of non-cholesterol     sterols, resulting in heart-related diseases. This study will evaluate the long term safety     and the ability to lower cholesterol levels with an investigational drug.   "
172071|NCT00092833|"     The purpose of this study is to provide an investigational drug to patients with a specific     type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption     of non-cholesterol sterols) in a treatment use setting.   "
172072|NCT00092846|"     The purpose of this study is to evaluate the ability of patients with intermediate risk of     heart disease to appropriately use a Self-Management System.   "
172073|NCT00092859|"     This is a 2-year study to assess the safety, tolerability, and efficacy of an investigational     drug in obese patients.   "
172075|NCT00092885|"     The purpose of this study is to determine the effect of an approved medication on the     symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous     membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis     and asthma.   "
172076|NCT00084838|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     tumor cells. Giving more than one chemotherapy drug with radiation therapy may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving intrathecal and systemic combination     chemotherapy together with radiation therapy works in treating young patients with newly     diagnosed central nervous system (CNS) atypical teratoid/rhabdoid tumors.   "
172077|NCT00084864|"     RATIONALE: Calcitriol and dexamethasone may slow the growth of prostate cancer cells.      PURPOSE: This randomized phase II trial is studying how well giving calcitriol together with     dexamethasone before radical prostatectomy works in treating patients with localized stage II     or stage III adenocarcinoma (cancer) of the prostate.   "
172078|NCT00084877|"     This phase I trial is studying the side effects and best dose of irinotecan and 3-AP in     treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy     such as irinotecan work in different ways to stop tumor cells from dividing so they stop     growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for     their growth and may help irinotecan kill more tumor cells by making them more sensitive to     the drug.   "
172079|NCT00084890|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Combining docetaxel with     carboplatin may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when     given together with carboplatin and to see how well they work in treating patients with     recurrent stage IVB squamous cell carcinoma (cancer) of the cervix.   "
172080|NCT00084903|"     RATIONALE: New diagnostic procedures such as fluorescence and reflectance spectroscopy     (shining light on tissue and measuring patterns of light reflected) may improve the ability     to noninvasively detect cervical intraepithelial neoplasia and dysplasia.      PURPOSE: This diagnostic trial is studying how well fluorescence and reflectance spectroscopy     during colposcopy work in detecting cervical intraepithelial neoplasia and dysplasia in     healthy participants with a history of normal Pap smears.   "
172081|NCT00084916|"     Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from     dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works     in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic     leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia in blastic phase   "
172082|NCT00084929|"     RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve     the ability to detect colorectal cancer and may provide a less invasive method of detection.      PURPOSE: This clinical trial is studying how well computed tomographic colonography works in     screening healthy participants for colorectal cancer.   "
172083|NCT00084942|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Combining more     than one chemotherapy drug may kill more tumor cells.      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine     in treating patients who have advanced and/or inoperable cholangiocarcinoma or carcinoma     (cancer) of the gallbladder.   "
172084|NCT00084981|"     This phase I trial is studying the side effects and best dose of decitabine and valproic acid     in treating patients with non-small cell lung cancer. Drugs used in chemotherapy, such as     decitabine and valproic acid, work in different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug may kill more tumor cells.   "
172085|NCT00085020|"     RATIONALE: GW572016 may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either     kill them or deliver tumor-killing substances to them without harming normal cells. Giving     GW572016 with trastuzumab may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of GW572016 when given     together with trastuzumab in treating patients with metastatic breast cancer that     overexpresses HER2/neu.   "
172086|NCT00085059|"     RATIONALE: Boron neutron capture therapy using boronophenylalanine-fructose complex may kill     tumor cells without harming normal tissue.      PURPOSE: This phase II trial is studying how well boron neutron capture therapy using     boronophenylalanine-fructose complex works in treating patients with metastatic melanoma.   "
172100|NCT00092976|"     The primary objective of this clinical research study is to evaluate the safety and efficacy     of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the     chromogenic substrate assay at the local laboratory.   "
180223|NCT00203073|"     It is thought that treating multiple sclerosis with Novantrone for a short period of time     prior to treatment with Copaxone may enhance the onset effect of Copaxone.   "
172087|NCT00085098|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or     die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus     radiation therapy in treating germ cell tumor.      PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well     it works compared to chemotherapy and radiation therapy in treating patients with newly     diagnosed primary CNS germ cell tumor.   "
172088|NCT00085111|"     This phase I trial is studying the side effects and best dose of bevacizumab in treating     young patients with refractory solid tumors. Monoclonal antibodies, such as bevacizumab, can     locate tumor cells and either kill them or deliver tumor-killing substances to them without     harming normal cells.   "
172103|NCT00093015|"     The purpose of this study is to assess the impact of treatment of anemia with darbepoetin     alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular     events, and (2) progression to end-stage renal disease or death, in subjects with chronic     kidney disease and type 2 diabetes mellitus.      Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD   "
172089|NCT00085124|"     This randomized phase III trial is studying daunorubicin, cytarabine, and oblimersen to see     how well they work compared to daunorubicin and cytarabine in treating older patients with     previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin     and cytarabine, work in different ways to stop cancer cells from dividing so they stop     growing or die. Oblimersen may increase the effectiveness of daunorubicin and cytarabine by     making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and     cytarabine are more effective with or without oblimersen in treating acute myeloid leukemia.   "
172090|NCT00085150|"     RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of LMB-2 immunotoxin     in treating young patients with relapsed or refractory leukemia or lymphoma.   "
172091|NCT00085163|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the     growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known     whether fluorouracil and leucovorin are more effective with or without celecoxib in treating     resected stage III adenocarcinoma (cancer) of the colon.      PURPOSE: This randomized phase III trial is studying celecoxib, fluorouracil, and leucovorin     to see how well they work compared to fluorouracil and leucovorin in treating patients who     have undergone surgery for stage III colon cancer.   "
172092|NCT00085176|"     RATIONALE: Cancer therapies may affect the ability of a child's brain and central nervous     system to function normally. Learning to identify which patients will develop complications     may improve the ability of doctors to plan cancer treatment and improve patient quality of     life.      PURPOSE: This clinical trial is studying neurobehavioral changes in children who have     received steroid therapy or intrathecal therapy for acute lymphoblastic leukemia.   "
172093|NCT00085189|"     This pilot phase II trial studies how well giving vaccine therapy works in treating patients     with stage IIC-IV melanoma. Vaccines made from melanoma peptides or antigens may help the     body build an effective immune response to kill tumor cells   "
172094|NCT00092898|"     This is a 6-month study with patients who have the rare disease, sitosterolemia which may     result in heart-related diseases. These patients have unusually high absorption of     non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether     absorption of these non-cholesterols can be reduced in these patients.   "
172095|NCT00092911|"     The main objective of this study is to compare the antidepressant efficacy and safety of     DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder.   "
172096|NCT00092924|"     The purpose of this study is to evaluate the efficacy and safety of TRM-1 in subjects with     relapsed or refractory non-small cell lung cancer.   "
172097|NCT00092937|"     This protocol is designed for a single specific patient. It uses busulfan as a conditioning     agent in a second stem cell transplant procedure for a patient with chronic granulomatous     disease (CGD), a disorder in which a certain type of white cells, called myeloid cells, do     not function properly. This causes increased risk of serious bacterial and fungal infections     that can lead to organ dysfunction, such as kidney disease, as well as formation of     granulomas-non-cancerous masses that can cause obstructions in the esophagus, stomach, and     intestines, and block urine flow from the kidneys and bladder.). The child in this study has     previously undergone a stem cell transplant to treat CGD, and, as a result, he is now     producing normal lymphocytes (another type of white cell). However, the myeloid cells from     the donor did not engraft successfully, and the patient is still producing his own defective     myeloid cells. In this study, the child will undergo a second stem cell transplant in     combination with busulfan, a drug that targets myeloid cells, killing them to make way for     healthy, donated myeloid cells.      Treatment includes the following procedures:        -  Medical evaluation to confirm that the patient is healthy enough to undergo the          transplantation        -  Treatment with busulfan, injected through the patient's central venous line        -  Stem cell transplantation through the central venous line        -  Blood tests on days 25, 56, and 91 after the transplant to assess how many cells are of          donor origin        -  Bone marrow aspiration on day 100, and then at 12, 24, and 36 months to assess how many          cells are of donor origin        -  Pulmonary function (breathing) test at 12 and 24 months        -  Physical examination and blood tests, weekly or twice weekly for the first 2 to 3 months          and at 4, 6, 12, 18, 24, 36, 48, and 60 months after transplant        -  Treatment for graft-versus-host disease (GVHD), if this complication develops. GVHD is          the attack of lymphocytes from the donor against the patient's own cells. This is good          if it is against abnormal cells, but bad if serious damage occurs to the patient's vital          organs. GVHD is treated with steroids and cyclosporine, and possibly other drugs if          needed.   "
172098|NCT00092950|"     This 2-part study will examine how much exercise people usually do in the course of their     daily lives and how two different types of exercise-stretching and walking-affect the amount     of fat in the body and certain hormones in the blood. It will also examine whether exercise     can be increased by physician counseling with and without the use of a pedometer, and if     exercising changes levels of stress, anxiety, and depression.      Breast cancer survivors and women at high risk for breast cancer who are between 18 and 75     years of age and who exercise less than 3 times per week may be eligible for this study.     Candidates are screened with a medical history and physical examination, and their endurance     and flexibility are tested by stretching exercises and by a 6-minute walk or run.      All participants complete study Part 1. Those who are eligible may also participate in Part     2.        -  Part 1: Subjects wear a pedometer (a small device that measures the number of steps          taken) on their waistband during all waking hours for 1 week without changing their          usual level of activity. Depending on their level of activity, subjects may be invited          to participate in Part 2 of the study.        -  Part 2: Subjects are placed in either a walking group or a stretching group for 12          weeks. At the end of the 12-week period, those in the walking group are offered          participation in the stretching group, and those in the stretching group are offered          participation in the walking group.      Walking group participants wear a pedometer every day for 12 weeks. They are asked to     gradually increase the number of steps they take each day, to keep a record of their daily     step count, and to report periodically to the study staff on their progress. For 1 week     during the study, participants also wear a device called an accelerometer that is used to     verify the accuracy of the pedometer step counts.      Stretching group participants follow a program of stretching exercises for 12 weeks, with     their progress monitored periodically by staff. During week 12, participants wear a pedometer     and accelerometer.      All Part 2 participants also have the following tests and procedures:        -  Blood draw: collected at the beginning and end of the study to test for certain hormones          and HDL cholesterol levels.        -  Questionnaires: about stress, anxiety, and depression levels; these are completed at the          beginning and end of the study, and a detailed questionnaire about diet is completed at          home or during a clinic visit.        -  Body composition measurement: A bioelectrical impedance test, which measures body fat,          is done at the beginning and end of the study. For this test, the subject lies on an          examining table and a small electrical current is passed through electrodes placed on          one hand and one foot. Although a small electrical current is used, this test is not          painful.        -  Endurance and flexibility testing: At the end of the study, participants repeat the          6-minute walk or run endurance test and the stretching flexibility test performed at          screening.   "
172099|NCT00092963|"     The purpose of this study is to test the effectiveness of an approved drug in the early     treatment of migraine while the pain is still mild.   "
172101|NCT00092989|"     The purpose of this study is to evaluate improved results of treatment for patients entering     an emergency department with asthma attacks when given an investigational IV administration     of an approved drug (MK-0476, montelukast sodium) in addition to approved standard treatment.   "
172102|NCT00093002|"     The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast     cancer treatment and assess the relationship between dose, exposure, degree of reduction in     tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.   "
172117|NCT00093210|"     The primary objective of this clinical research study is to establish the bioequivalence of 2     treatments, rFIX and rFIX-R, when given as a 10-minute intravenous bolus infusion.   "
172104|NCT00093028|"     The purpose of this study is        -  to find out the effects of treating patients with two new chemotherapy drugs (bortezomib          and Revlimid™),        -  to study how many patients' myeloma responds to treatment on this study, and how many          patients survive after this treatment,        -  to learn if a patient's genetic makeup before and after treatment can predict which          patients will respond to bortezomib and Revlimid™, and to learn more about how the body          responds (gene array studies).   "
172105|NCT00093041|"     The purpose of this trial is to determine the safety of zalutumumab as a treatment for head     and neck cancer.   "
172106|NCT00093054|"     The purpose of this study is to determine whether daily consumption of cranberry juice     lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This     study will also determine whether drinking cranberry juice for 6 months selects for less     virulent bacteria in the rectal, vaginal, and urethral areas.   "
172107|NCT00093067|"     The purpose of this study is to compare the safety and efficacy of daptomycin, an antibiotic,     to standard therapy in subjects who have infective endocarditis or bacteremia due to     Staphylococcus aureus (S. aureus).   "
172108|NCT00093080|"     The purpose of this study is to assess the efficacy of ridaforolimus when administered once     daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma.   "
172109|NCT00093093|"     The purpose of this study is to determine the safety and effectiveness of viramidine to     ribavirin in chronic hepatitis C patients who have never before received treatment.   "
172110|NCT00093119|"     This trial will treat patients previously treated for advanced (metastatic) melanoma (skin     cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered     weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles     of therapy will be given to determine the anti-tumor response of the new chemotherapy.     Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows     continuing benefit.   "
172111|NCT00093132|"     PURPOSE: This trial is designed to compare the combination of the investigational oral     cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced     Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy treatment.     Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.      WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member     of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically     proven to be one of the most effective classes of anticancer therapies. Unlike the currently     marketed platinum-based drugs, satraplatin can be given orally.      RATIONALE: Intravenously administered platinum-based drugs are currently used in combination     with radiation therapy in the treatment of patients with locally advanced NSCLC. The purpose     of this Phase I trial is to determine a tolerable dose and schedule for the oral platinum     drug (satraplatin) when given to NSCLC patients throughout the course of their radiotherapy     treatment.   "
172112|NCT00093145|"     This trial will treat patients with advanced breast cancer with a new anti-cancer medicine     used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel     (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a     weekly basis and may continue on therapy as long as their condition improves and drug     toxicity is tolerated.   "
172113|NCT00093158|"     The purpose of this study is to show that, when compared with heparin (enoxaparin or     unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the     time of percutaneous coronary intervention [PCI]; Arm A):        1. Bivalirudin with routine GPIIb/IIIa inhibition (either started upfront or at the time of          PCI; Arm B) provides non-inferior or superior overall clinical outcomes and        2. Bivalirudin alone (Arm C) reduces clinically significant bleeding. An important          secondary objective for this comparison is to show that bivalirudin is not inferior for          ischemic complications.   "
172114|NCT00093171|"     The primary objective of this clinical research study is to assess the safety and efficacy of     rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C     ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor     surgical procedures).   "
172115|NCT00093184|"     The purpose of this study is to demonstrate the benefit of bivalirudin in combination with     clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications     associated with early invasive management of patients presenting with an ST Elevation     Myocardial Infarction (STEMI) and undergoing primary PCI, while providing similar rates of     ischemic events when compared to published results of relevant trials.   "
172163|NCT00095745|"     This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in     outpatients with major depressive disorder who have experienced an incomplete response to an     ongoing antidepressant trial.   "
172164|NCT00095758|"     This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the     safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant     treatment in patients with Major Depressive Disorder.   "
172196|NCT00096187|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to     stop tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating     patients with recurrent or persistent low-risk gestational trophoblastic tumor after a molar     pregnancy.   "
172116|NCT00093197|"     Restoring blood flow to coronary arteries as quickly as possible is the best way to reduce     the damage to the muscle that occurs with a heart attack. However, up to 25-50% of patients     who have angioplasty may have ongoing damage to the heart muscle when the blockage is opened     and blood flow is restored. Complications which may result from this ongoing damage include a     larger area of damaged muscle in the heart, enlargement of the heart, an increased risk of     death, and an increased risk of heart failure. Some of the ongoing damage may involve     increased levels of the protein kinase C (PKC) enzyme. KAI-9803 is a selective inhibitor of     delta PKC. In this study, delta PKC is used with angioplasty and other standard procedures to     restore blood flow after a heart attack. This study is designed to evaluate safety of     different amounts of KAI-9803 when used in treating heart attack patients undergoing     angioplasty. We will also try to evaluate whether KAI-9803 can reduce the amount of heart     muscle damage and the complications that may occur in these patients.   "
172118|NCT00093223|"     This trial will treat patients with a new chemotherapeutic medicine who have undergone a     successful and uncomplicated de novo stent placement in up to two native coronary arteries.     The purpose of the trial is to determine the appropriate dose of the new medicine for future     trials and to evaluate the incidence of treatment-emergent adverse events and serious adverse     events.   "
172119|NCT00093236|"     The purpose of this study is to determine the effect of gum infection on parameters of     cardio-vascular disease.   "
172120|NCT00095160|"     Study 1493-852A is a phase 1 study with the primary objective of determining safety and the     highest tolerated dose of an experimental immune response modifier administered intravenously     to patients with solid organ tumors not responsive to currently available treatments. The     secondary objective of the study is to monitor the tumor response to this form of treatment.   "
172121|NCT00095173|"     The primary purpose of the clinical research study is to assess the safety of treating     children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will     assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid     Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence     of disease flare.   "
172122|NCT00095186|"     The purpose of this study is to determine if orally-administered recombinant human     lactoferrin is effective in the treatment of advanced renal cell carcinoma (RCC) in patients     who have failed at least one prior systemic therapy for RCC.   "
172123|NCT00095199|"     This trial is a multicenter, open-label, randomized, Phase III study in patients with     recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial     platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as     chemotherapy at the investigator's choice. Within each chemotherapy group, patients will be     randomized to receive Cetuximab plus chemotherapy or chemotherapy alone (Cetuximab &     Pemetrexed or Pemetrexed alone; Cetuximab & Docetaxel or Docetaxel alone).   "
172124|NCT00095212|"     Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause     critical reductions in physical functioning and reduced bone density. The effects of     long-term androgen therapy on lean body mass, bone density and other clinical endpoints     including quality of life, functional status and neurocognitive function in HIV-infected     women are not known.   "
172125|NCT00095225|"     This Phase II, multicenter, randomized trial is designed to make preliminary evaluations of     the efficacy of combining bevacizumab with chemotherapy (docetaxel or pemetrexed) or Tarceva     relative to chemotherapy (docetaxel or pemetrexed) alone in patients with previously treated     advanced NSCLC.   "
172126|NCT00095238|"     The purpose of this clinical research study is to learn if Irbesartan is superior to placebo     in reducing mortality and cardiovascular morbidity in subjects with heart failure with     preserved systolic function. The safety of this treatment will also be studied.   "
172127|NCT00095251|"     Delirium has recently been shown as a predictor of death, increased cost, and longer length     of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain,     but may contribute to patients' transitioning into delirium. It is possible that modifying     the paradigm for sedation using novel therapies targeted at different receptors, such as     dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide     efficacious sedation yet reduce the development, duration, and severity of acute brain     dysfunction (delirium).   "
172128|NCT00095264|"     The purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment     on erythroid response in anemic subjects with low risk Myelodysplastic Syndrome (MDS).   "
172129|NCT00095277|"     The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in     subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.   "
172130|NCT00095290|"     Albumin in the urine is usually a signal that you might be at risk of cardiovascular     complications. The purpose of this study is to determine if the albumin in your urine can be     decreased by the treatment regimen that consists of irbesartan taken at the same time with     ramipril.   "
172131|NCT00095303|"     The purpose of this study is to compare Brief Strategic Family Therapy (BSFT) for Adolescent     Drug Abusers to treatment as usual (TAU).      An additional follow up assessment, funded by an American Recovery & Reinvestment Act (ARRA)     grant, was completed 5 years post randomization in order to examine the long term effects of     outpatient treatments for illicit drug using adolescents.   "
172132|NCT00095316|"     Adults admitted to intensive care units are at risk for a variety of complications. One of     the most frequent complications is the development of new infections. Infections due to a     fungus called Candida are of particular concern. This study will test the possibility that     caspofungin, a new therapy for fungal infections, may reduce the rate of Candida infections     in subjects at risk.   "
172133|NCT00095329|"     The purpose of this study is to determine the safety and tolerability of the drug sirolimus     in patients with multiple sclerosis (MS) who have failed other treatments.   "
172134|NCT00095342|"     The primary objective of this clinical research study is to compare the efficacy and the     safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active     Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX).   "
172165|NCT00095771|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to     stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells and may be an effective treatment for patients with     glioma. Drugs such as arsenic trioxide may also make the tumor cells more sensitive to     radiation therapy. Combining arsenic trioxide with radiation therapy may kill more tumor     cells.      PURPOSE: Phase I trial to study the effectiveness of combining arsenic trioxide with     radiation therapy in treating patients who have newly diagnosed gliomas.   "
172166|NCT00095784|"     This phase II trial studies the side effects and how well decitabine works in treating     patients with myelofibrosis, a cancer of the blood system associated with fibrosis (scar     tissue) in the bone marrow that is advanced and for which there is no standard therapy.     Decitabine may block the actions of some proteins that are responsible for turning certain     genes off in various cancers including myelofibrosis.   "
172167|NCT00095797|"     Phase I trial to study the effectiveness of XK469R in treating patients who have refractory     hematologic cancer. Drugs used in chemotherapy, such XK469R, work in different ways to stop     cancer cells from dividing so they stop growing or die   "
172135|NCT00095355|"     This study will examine whether lithium carbonate, given alone or with divalproex, increases     the amount of brain-derived neurotrophic factor (BDNF) in the spinal fluid of patients with     Huntington's disease (HD), a hereditary disorder of the central nervous system. Patients with     this fatal degenerative disease have lower amounts of substances in the brain and spinal     fluid called trophic or growth factors. One of these factors is BDNF. A possible treatment     for HD may be to increase the levels of BDNF. Lithium carbonate, a drug used to treat bipolar     disorder, and divalproex, a drug used to treat mood disorders and seizure disorders, have     both been shown to increase the amount of BDNF protein in laboratory studies.      Patients 18 to 70 years old with a DNA-confirmed diagnosis of Huntington's disease may be     eligible for this study. Candidates are screened with a medical history and physical     examination, neurological evaluation, blood and urine tests, and electrocardiogram (EKG).      Participants take lithium carbonate with and without divalproex. They also receive placebo     (an inactive substance) for portions of the study. On the first day of the study, patients     are given a supply of pills with instructions on how to take them. Blood pressure and pulse     are measured, and blood and urine tests may be done. Patients are evaluated with standardized     tests and scales for assessment of various aspects of HD.      Patients return to the clinic once a week for follow-up evaluations, including blood and     urine tests, physical examinations, disease assessments, and a review of medication side     effects. Each week, they receive a new supply of medications and instructions on how to take     them. At the end of the sixth week, they finish taking the medications.      During the study, patients undergo three lumbar punctures (spinal taps) - at weeks 2, 4, and     6 - to measure BDNF and various other brain chemicals. For this test, a local anesthetic is     given and a needle is inserted in the space between the bones in the lower back where the CSF     circulates below the spinal cord. A small amount of fluid is collected through the needle.     The procedure generally takes from 5 to 20 minutes.      Patients return to the clinic 2 weeks after completing the study medication for a final     evaluation, including a physical examination and blood and urine tests.   "
172136|NCT00095368|"     The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP     tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation     will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).   "
172137|NCT00095381|"     BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their     growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating     patients who have recurrent or refractory advanced T-cell leukemia.      Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every     week for up to six courses. Patients are not required to be hospitalized for the     administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777     twice a week for 6 weeks.   "
172138|NCT00095394|"     The purpose of this clinical research is to learn if severe hypertension can be better     controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients     who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the     study will also evaluate the safety and tolerability of the drugs.   "
172139|NCT00095407|"     This study will identify the regions of the brain that are involved in personality trait     knowledge-that is, what a person knows about aspects of personality such as generous,     honest, and others. It will also examine brain areas relating to a person's knowledge of     how likeable those personality traits are, being familiar with the traits, and the degree of     associating such traits with one's self. There has not been any previous study, through     modern imaging techniques, on the location of the brain and the concepts of personality     traits.      Patients ages 21 to 65 who are in good health, are right handed, and native speakers of     English may be eligible for this study. Pregnant women are not eligible. There will be 200     participants involved in pencil-and-paper or computer tasks. Also, there will be three     functional magnetic resonance imaging (fMRI) experiments with 32 participants. Patients may     participate in up to three fMRI experiments.      Patients will be recruited through NIH's Normal Control Database. They would need to have had     a neuroexamination conducted by an NIH doctor within the last year. Patients will be     interviewed for any medical, neurological, or psychological condition that would make it     difficult to read the fMRI results. Depending on the studies that patients take part in, they     will have different questionnaires to complete. They may also perform a computerized test     that measures word associations. These tests will take about 1 to 2 hours.      The technique of MRI uses a strong magnetic field and radio waves to obtain images of body     organs and tissues. During the initial MRI scan, patients will lie still on a table that will     slide into the enclosed tunnel of the scanner. They will be in the scanner not longer than 2     hours. During the procedure, they may be asked to lie as still as possible for up to 1 hour     at a time. As the scanner takes pictures, patients will hear knocking or beeping sounds, and     they will wear earplugs to reduce the noise. Patients will be able to communicate with the     MRI staff at all times during the scan, and they may ask to be moved out of the machine at     any time. Then the functional MRI (fMRI) scan will involve taking pictures of the brain while     patients are performing tasks. All the tasks will be explained, and patients will have the     chance to practice them before entering the scanner. For this activity, patients will be     asked to make decisions about what they are seeing in the tasks presented to them. They will     decide yes and no by pressing a left or right button. This scan will take about 1 hour.     Afterward, patients may be asked to fill out written questionnaires or to perform reaction     time tasks by using a computer.      This study will not have a direct benefit for participants. However, it is hoped that     information gained will enhance researchers' understanding about which areas of the brain are     necessary to perform certain tasks.   "
172140|NCT00095420|"     This study will determine whether peer interaction training interventions are effective in     enhancing the social relationships of children with autism.   "
172141|NCT00095433|"     This is a Phase III, open-label, multicenter extension study of intravitreally administered     ranibizumab in subjects with primary or recurrent subfoveal choroidal neovascularization     (CNV) secondary to AMD who have completed the treatment phase of a Genentech sponsored Phase     I or Phase I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g).   "
172142|NCT00095446|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to     insulin lispro, both in insulin pumps, in standard clinical practice.   "
172143|NCT00095459|"     Background:        -  BAY 43-9006 is an inhibitor of wild-type and mutant B-Raf and c-Raf kinase isoforms in          vitro, but it also inhibits p38, c-kit, VEGFR-2 and PDGFR-Beta affecting tumor growth as          well as possibly promoting apoptosis by events downstream of c-Raf.        -  Bevacizumab is a humanized IgG1 monoclonal antibody (MAb) that binds all biologically          active isoforms of human vascular endothelial growth factor (VEGF, or VEGF-A) with high          affinity (k(d)= 1.1nM)        -  The most common adverse events associated with bevacizumab of any severity include          asthenia, pain, headache, hypertension, diarrhea, stomatitis, constipation, epistaxis,          dyspnea, dermatitis and proteinuria.        -  This Phase I trial is open to patients with all solid tumors.      Objectives:        -  Determine the safety and toxicity of the combination of BAY 43-9006 (Sorafenib) and          bevacizumab.        -  Determine estimates of biochemical changes in the Ras-Raf-MAPK and VEGF signal          transduction pathways in tumor and stromal cells in response to treatment at the MTD, at          least in a pilot fashion, if those changes are statistically significant.      Eligibility:        -  Adults with histologically documented solid tumor malignancy that is metastatic or          unresectable and for which standard curative therapies do not exist or are no longer          effective.        -  Patients must be off prior chemotherapy, radiation therapy, hormonal therapy, or          biological therapy for at least 4 weeks.        -  All patients enrolling in cohort 2 must have at least one lesion amenable to biopsy.        -  ECOG performance status 0 or 1 and adequate organ and marrow function.      Design:        -  Cohort I will receive BAY 43-9006 and bevacizumab together at the start of study in a          dose escalation fashion.        -  Cohort II will be randomized as to which agent they receive for cycle one. Cycles 2 and          beyond are treated using both agents.        -  Tumor biopsies will be obtained from patients in Cohort II before treatment, two weeks          into mono-therapy, and two weeks into combinatorial therapy.        -  DCE-MRI studies will be obtained on patients in Cohort II before treatment, two weeks          into monotherapy, four weeks into monotherapy, and two weeks into combinatorial therapy.        -  FDG-PET studies will be obtained on patients in Cohort II before treatment, two weeks          into mono-therapy, and two weeks into combinatorial therapy.        -  Patients will be evaluated for toxicity in clinic every 2 weeks for Cycles 1 and 2, and          then every 4 weeks.        -  Patients will be evaluated for response every 8 weeks using the RECIST criteria.        -  Approximately 62 patients will be needed to achieve the objectives of the trial.   "
172144|NCT00095472|"     This study examines ways in which nitric oxide (NO), an important molecule that controls how     blood flows through the body's vessels, might be restored with a compound called sodium     nitrite. It is hoped that the result will reverse the effect of decreased flow of blood due     to sickled cells-that is, cells that have changed into the shape of a crescent or sickle.     Sickle cell disease is the most common genetic disease affecting African Americans. About 8%     of that population has the sickle cell trait. The changed cells can become attached to blood     vessels, decreasing blood flow to vital organs. There can be the loss of needed proteins,     including hemoglobin, that deliver oxygen throughout the body.      Adults at least 18 years of age who have the SS form of sickle cell disease or     S-beta-thalassemia, are in either a steady state or crisis, give informed and written consent     for participation, and have had a negative pregnancy test may be eligible for this study.     Adults with any other disease that puts them at risk for reduced circulation are not     eligible. Women who are breastfeeding are not eligible.      Participants will undergo a medical history, including family medical history, and a detailed     physical evaluation, to take about 1 hour. There will be a collection of blood;     echocardiogram, which involves taking a picture of the heart and its four chambers; and     measurement of exhaled carbon monoxide, carbon dioxide, and NO. A procedure called orthogonal     polarization spectral imaging will be performed. A small object the size of a Popsicle stick     will be placed under the tongue or on a fingertip. This procedure presents a picture of blood     flow and how the red blood cells appear as they circulate through blood vessels. The study     will be conducted in the Vascular Laboratory/Cardiovascular Floor or Intensive Care and will     last about 4 hours.      During the study, patients will lie in an adjustable reclining bed and chair. Small tubes     will be placed in the artery and vein of the forearm at the inside of the elbow. A small     pressure cuff will be applied to the wrist and a larger one to the upper arm. Both cuffs will     be inflated with air. A strain gauge, resembling a rubber band, will go around the widest     part of the forearm. When the pressure cuffs fill with air, blood will flow into the arm, and     information from the strain gauge will be recorded. Between administrations of each medicine,     there will be 30-minute rests. Normal saline will be put into the small tube in the artery.     Measurements of the blood flow in the forearm will be taken, and a small blood sample will be     taken to measure blood counts, proteins, and other natural body chemicals. Then a medicine     called sodium nitroprusside, which causes blood vessels to expand and increase blood flow,     will be placed into the forearm. It will be given at three different doses for 3 minutes     each, with measurements recorded after each dose. Then a medicine called L-NMMA will be     placed into the forearm. L-NMMA generally decreases local blood flow by preventing nitric     oxide from being produced in the cells lining the blood vessels. It will be given at two     different doses for 5 minutes each, with blood flow measured after each dose. Next, nitrite     will be placed in the forearm at three different doses for 5 minutes each. Before and after     nitrite is given, the researchers will measure the amount of the NO, carbon monoxide, and     carbon dioxide that the patients breathe out. Then the procedure for administering normal     saline, sodium nitroprusside, and L-NMMA will be repeated, as will a blood test.      This study will not have a direct benefit for participants. However, it is hoped that the     information gained from the study will help to develop treatment options for patients with     sickle cell disease.   "
172242|NCT00096811|"     The purpose of this clinical research study is to provide entecavir to subjects with chronic     Hepatitis B infection who have failed or who have demonstrated intolerance of marketed     therapies or for those in whom use of these agents is contraindicated and that have no other     available treatment options.   "
172145|NCT00095485|"     This study will examine the changes that the move from NIH's Building 10 Clinical Center (CC)     into the Clinical Research Center (CRC) may have on the amount of activity a person engages     in daily, as registered by a pedometer, which measures horizontal and vertical steps. The     investigators in this study hope to better understand the impact that the move will have had     on one group of employees compared with the impact for other groups. Moving to a new work     location may require physical activity that is different from what employees currently     experience on the job. In the new location, they may be walking longer or shorter distances;     they may also be climbing fewer or more stairs. In addition, they may need to walk more     quickly to accomplish the same tasks. It is important to understand how the move from the CC     to the CRC influences employees' health, well-being, and overall function. Physical measures,     such as blood pressure, will be examined. So will how well employees are adjusting to the new     location-for example, through information about work-related injuries.      Clinical Center employees who are able to walk, whose move dates allow 10 days in the     Clinical Center before the move, who wish to participate in the study and are able to wear a     pedometer, and whose work requirements include a sufficient amount of walking may be eligible     for the study.      Participants will undergo the following procedures before the move into the CRC and then 1     month after the move. Each evaluation will take about 30 minutes:        -  Brief history about age, medical problems, and current medications.        -  Measurements of heart rate, blood pressure, height, and weight.        -  Completing a brief questionnaire about the history of injuries, such as back pain,          tendonitis, and bursitis.      In addition, participants will complete a questionnaire about daily life and leisure     activities, consisting of 94 questions, to take about 20 minutes to complete. There will also     be a measurement of the distance that participants can walk in 2 minutes.      A pedometer will be provided to each participant and will remain the property of that person.     Participants will receive a daily log on which to record the number of steps they have walked     and the distance as registered by the pedometer. About 5 minutes a day will be needed to     record such information. The information that participants provide will be coded. They will     not be personally identified, nor will the information be discussed with other people,     including supervisors or co-workers.      Information collected will be analyzed for changes in activity patterns and will be analyzed     by groups of staff. For example, the investigators may wish to compare the activity of nurses     before and after the move and then compare that information with information collected from     food service workers, or personnel serving as messengers or escorts. Participants may find     the information gathered to be useful to them as individuals. That is, they may learn that     their activity has increased as a result of the move to the new location. They may have     benefited by having lost weight or lowered their blood pressure.   "
172146|NCT00095498|"     This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in     the treatment of Rheumatoid Arthritis (RA).   "
172147|NCT00095511|"     The purpose of this trial is to test the safety & efficacy of aripiprazole in patients with     Bipolar Mania for a period of at least 12 weeks.   "
172148|NCT00095524|"     The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on     weight change.   "
172149|NCT00095537|"     The purpose of this trial is to identify the highest oral dose of BMS-599626, a drug that is     directed against EGFR and HER2 proteins, that can be given safely on a daily schedule of 21     days with a 7 day rest period in patients with cancer who no longer benefit from other     commonly used treatments. The study will also test for other proteins that may be affected by     BMS-599626; and the level of study drug in the blood will be studied.   "
172150|NCT00095550|"     The purpose of this clinical research is to learn if moderate hypertension can be better     controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients     who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the     study will also evaluate the safety and tolerability of the drugs.   "
172151|NCT00095563|"     Phase II trial to study the effectiveness of lapatinib in treating patients who have     recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers. Lapatinib     may stop the growth of tumor cells by blocking the enzymes necessary for their growth.   "
172152|NCT00095576|"     This study will test the safety and efficacy of an investigational Human Immunodeficiency     Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or     control of HIV viral load in subjects who become HIV infected.      On September 18, 2007 the Protocol V520-023 DSMB (Data & Safety Monitoring Board) reviewed     data from a planned interim analysis. These data demonstrated that the investigational     vaccine candidate was not effective, and all vaccinations in the study were halted.      Participants were encouraged to continue to come to the clinic for scheduled visits and     ongoing risk reduction counseling since the vaccine was not effective.   "
172153|NCT00095589|"     RATIONALE: New diagnostic procedures such as microsatellite analysis of sediment in the urine     may improve the ability to detect bladder cancer without invasive procedures.      PURPOSE: Diagnostic trial to study the effectiveness of microsatellite analysis of sediment     in the urine in detecting bladder cancer in healthy participants, participants who have     genitourinary conditions requiring cystoscopy, and patients who have bladder cancer.   "
172154|NCT00095628|"     This phase II trial is studying how well SB-715992 works in treating patients with recurrent     or metastatic head and neck cancer. Drugs used in chemotherapy, such as SB-715992, work in     different ways to stop tumor cells from dividing so they stop growing or die.   "
172155|NCT00095641|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     tumor cells from dividing so they stop growing or die. Giving capecitabine after surgery may     kill any remaining tumor cells.      PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who     have undergone surgery for locally recurrent or persistenthead and neck cancer.   "
172156|NCT00095654|"     The purpose of this study is to determine if ramipril and/or rosiglitazone prevent the onset     of type 2 diabetes.   "
172157|NCT00095667|"     Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their     growth. Phase II trial to study the effectiveness of lapatinib in treating patients who have     recurrent or metastatic prostate cancer.   "
172158|NCT00095680|"     The main objective of this study is to assess the long-term effectiveness of SCIO-469 as     monotherapy, or in combination with bortezomib in relapsed, refractory patients with multiple     myeloma (MM) who have previously demonstrated clinical benefit in the Scios B003 study.   "
172159|NCT00095693|"     Phase II trial to study the effectiveness of sorafenib tosylate in treating patients who have     locally advanced, metastatic, or locally recurrent thyroid cancer. Sorafenib tosylate may     stop the growth of tumor cells by blocking the enzymes necessary for their growth and by     stopping blood flow to the tumor.   "
172160|NCT00095706|"     The purpose of this study is to evaluate the safety and effectiveness of combined treatment     with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with     HER2-positive metastatic breast cancer.   "
172161|NCT00095719|"     The purpose of this trial is to test the safety & tolerability of intramuscular aripiprazole     in acutely agitated patients diagnosed with Dementia.   "
172162|NCT00095732|"     The purpose of this study is to determine the most effective dose of a new enzyme therapy on     oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic     insufficiency.   "
172169|NCT00095823|"     This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the     safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant     treatment in patients with Major Depressive Disorder.   "
172170|NCT00095836|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth.      PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have     locally advanced or metastatic thyroid cancer that did not respond to iodine therapy.   "
172171|NCT00095862|"     RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune     response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in     different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa     may interfere with the growth of tumor cells. Combining vaccine therapy with cyclophosphamide     and interferon alfa may kill more tumor cells.      PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with     interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer.   "
172172|NCT00095875|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and     carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or     die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy     with radiation therapy may kill more tumor cells. It is not yet known which regimen of     chemotherapy and radiation therapy is most effective in treating head and neck cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of     chemotherapy and radiation therapy in treating patients who have stage III or stage IV head     and neck cancer.   "
172173|NCT00095888|"     Phase II trial to study the effectiveness of combining 3-AP with gemcitabine in treating     patients who have refractory metastatic breast cancer. Drugs used in chemotherapy, such as     3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop     growing or die. Combining 3-AP with gemcitabine may kill more tumor cells   "
172174|NCT00095901|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who     have locally recurrent or metastatic nasopharyngeal cancer.   "
172175|NCT00095914|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways     to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with     ABI-007 may kill more tumor cells.      PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with     ABI-007 in treating patients who have locally advanced or metastatic solid tumors.   "
172176|NCT00095927|"     This research study is studying a drug called Amifostine as a treatment for squamous cell     carcinoma in the head and/or neck area.   "
172177|NCT00095940|"     This phase I/II trial studies lapatinib to see how well it works in treating young patients     with recurrent or refractory central nervous system (CNS) tumors. Lapatinib may stop the     growth of tumor cells by blocking the enzymes necessary for their growth.   "
172178|NCT00095953|"     RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with     metastatic or recurrent malignant melanoma.   "
172179|NCT00095966|"     Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by     blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as     gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or     die. Giving sorafenib with gemcitabine may kill more tumor cells. This phase II trial is     studying how well giving sorafenib together with gemcitabine works in treating patients with     locally advanced or metastatic pancreatic cancer.   "
172180|NCT00095979|"     Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells     from dividing so they stop growing or die. This phase II trial is studying how well     ixabepilone works in treating patients with recurrent or persistent endometrial cancer.   "
172181|NCT00095992|"     RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with     locally advanced, recurrent, or metastatic liver cancer.   "
172182|NCT00096005|"     This phase I trial is studying the side effects and best dose of giving tanespimycin together     with bortezomib in treating patients with advanced solid tumors or lymphomas. (Accrual for     lymphoma patients closed as of 11/27/09) Drugs used in chemotherapy, such as tanespimycin,     work in different ways to stop cancer cells from dividing so they stop growing or die.     Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their     growth. It may also increase the effectiveness of tanespimycin by making cancer cells more     sensitive to the drug. Combining tanespimycin with bortezomib may kill more cancer cells.   "
172183|NCT00096018|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop     cancer cells from dividing so they stop growing or die. Biological therapies such as     thalidomide use different ways to stimulate the immune system and stop cancer cells from     growing. Combining fludarabine with thalidomide may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of thalidomide when     given together with fludarabine and to see how well they work in treating patients with newly     diagnosed B-cell chronic lymphocytic leukemia.   "
172184|NCT00096031|"     RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by     blocking the enzymes necessary for their growth.      PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with     metastatic esophageal cancer or gastroesophageal junction cancer.   "
172185|NCT00096044|"     RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the     immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can     locate cancer cells and either kill them or deliver cancer-killing substances to them without     harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without     rituximab works in treating patients with relapsed or refractory chronic lymphocytic     leukemia.   "
172186|NCT00096057|"     RATIONALE: Monoclonal antibodies such as HuHMFG1 can locate tumor cells and either kill them     or deliver tumor-killing substances to them without harming normal cells.      PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody     HuHMFG1 in treating women with locally advanced or metastatic breast cancer.   "
172187|NCT00096070|"     This phase II trial is studying how well giving radiation therapy together with oxaliplatin     and fluorouracil followed by gemcitabine works in treating patients with locally advanced,     unresectable pancreatic cancer. Radiation therapy uses high-energy x-rays to damage tumor     cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and gemcitabine, work     in different ways to stop tumor cells from dividing so they stop growing or die. Oxaliplatin     may also make the tumor cells more sensitive to radiation therapy. Giving radiation therapy     with chemotherapy may kill more tumor cells.   "
172188|NCT00096083|"     RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances     directly into the liver. Drugs used in chemotherapy, such as melphalan, work in different     ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different     ways may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving an hepatic arterial infusion of     melphalan together with hepatic perfusion works in treating patients with unresectable liver     cancer.   "
172189|NCT00096096|"     RATIONALE: Tacrolimus and mycophenolate mofetil may be an effective treatment for     graft-versus-host disease caused by donor stem cell transplantation.      PURPOSE: This phase II trial is studying how well giving tacrolimus together with     mycophenolate mofetil works in preventing acute graft-versus-host disease in patients who are     undergoing donor stem cell transplantation for advanced hematologic cancer.   "
172190|NCT00096109|"     This phase II trial is studying how well tanespimycin works in treating women with refractory     locally advanced or metastatic breast cancer. Drugs used in chemotherapy, such as     tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing     or die   "
172191|NCT00096122|"     This phase I/II trial is studying the side effects and best dose of tipifarnib when given     with idarubicin and cytarabine and to see how well it works in treating patients with newly     diagnosed myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy,     such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing     so they stop growing or die. Tipifarnib (Zarnestra) may stop the growth of cancer cells by     blocking the enzymes necessary for their growth. Giving idarubicin and cytarabine with     tipifarnib may kill more cancer cells.   "
172192|NCT00096135|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     cancer cells. Giving combination chemotherapy together with radiation therapy may kill more     cancer cells.      PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation     therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the     CNS and/or testes.   "
172193|NCT00096148|"     Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop     cancer cells from dividing so they stop growing or die. Bevacizumab may stop the growth of     cancer by stopping blood flow to the leukemic cells in the bone marrow. Giving idarubicin and     cytarabine with bevacizumab may kill more cancer cells. It is not yet know whether giving     idarubicin together with cytarabine is more effective with or without bevacizumab in treating     acute myeloid leukemia. This randomized phase II trial is studying how well giving idarubicin     and cytarabine together with bevacizumab works compared to idarubicin and cytarabine alone in     treating patients with newly diagnosed acute myeloid leukemia   "
172194|NCT00096161|"     This phase II trial studies pentostatin and donor lymphocyte infusion in preventing graft     rejection in patients who have undergone donor stem cell transplant. Giving pentostatin and     an infusion of the donor's T cells (donor lymphocyte infusion) after a donor stem cell     transplant may stop the patient's immune system from rejecting the donor's stem cells. The     donated stem cells may replace the patient's immune cells and help destroy any remaining     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can     also make an immune response against the body's normal cells. Giving pentostatin before donor     lymphocyte infusion may stop this from happening.   "
172195|NCT00096174|"     RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so     they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.     Cetuximab may make the tumor cells more sensitive to radiation therapy and chemotherapy.     Giving monoclonal antibody therapy together with chemoradiotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together     with radiation therapy works in treating patients with locally advanced or regional stage IV     head and neck cancer that cannot be removed by surgery.   "
172197|NCT00096200|"     Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their     growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as     paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they     stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells.     This randomized phase II trial is studying how well giving sorafenib together with paclitaxel     and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal     cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).   "
172198|NCT00096213|"     RATIONALE: Intralesional resection is a less invasive type of surgery for chondrosarcoma of     the bone and may have fewer side effects and improve recovery.      PURPOSE: This phase II trial is studying how well intralesional resection works in treating     patients with low-grade chondrosarcoma of the bone.   "
172211|NCT00096395|"     This phase II trial is studying how well giving sorafenib together with gemcitabine works in     treating patients with recurrent or refractory ovarian cancer or primary peritoneal cancer.     Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their     growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as     gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or     die. Giving sorafenib with gemcitabine may kill more tumor cells.   "
172199|NCT00096226|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Giving paclitaxel and carboplatin together with     radiation therapy before surgery may shrink the tumor so that it can be removed. Giving     chemotherapy after surgery may kill any tumor cells remaining after surgery.      PURPOSE: This phase II trial is studying how well giving paclitaxel and carboplatin together     with radiation therapy works in treating patients who are undergoing surgery for stage III     non-small cell lung cancer.   "
172200|NCT00096239|"     RATIONALE: CP-547,632 may stop the growth of tumor cells by blocking the enzymes necessary     for their growth and by stopping blood flow to the tumor.      PURPOSE: This phase II trial is studying how well CP-547,632 works in treating patients with     recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.   "
172201|NCT00096265|"     This randomized phase III trial is studying whole-brain radiation therapy and stereotactic     radiosurgery with or without temozolomide or erlotinib to see how well they work compared to     whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain     metastases secondary to non-small cell lung cancer. Radiation therapy uses high-energy x-rays     to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the     tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as     temozolomide, work in different ways to stop tumor cells from dividing so they stop growing     or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth and by blocking blood flow to the tumor. It is not yet known whether radiation     therapy and stereotactic radiosurgery are more effective with or without temozolomide or     erlotinib in treating brain metastases.   "
172202|NCT00096278|"     This randomized phase III trial is studying giving oxaliplatin, leucovorin, and fluorouracil     together with bevacizumab to see how well it works compared to oxaliplatin, leucovorin, and     fluorouracil alone in treating patients who have undergone surgery for stage II or stage III     colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,     work in different ways to stop tumor cells from dividing so they stop growing or die.     Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also     stop the growth of tumor cells by stopping blood flow to the tumor. Giving chemotherapy     together with bevacizumab may kill more tumor cells. It is not yet known whether treatment     with oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab     in treating patients who have undergone surgery for colon cancer.   "
172203|NCT00096291|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin and paclitaxel, work in different     ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy     before and after surgery may shrink the tumor so it can be removed and may kill any tumor     cells remaining after surgery.      PURPOSE: This randomized phase II trial is comparing two different regimens of doxorubicin     and paclitaxel to see how well they work in treating women who are undergoing surgery for     breast cancer.   "
172204|NCT00096304|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin and docetaxel, work in different     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one     drug may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of epirubicin when     given with docetaxel in treating patients with metastatic prostate cancer.   "
172205|NCT00096317|"     RATIONALE: Drugs used in chemotherapy, such as ixabepilone and ketoconazole, work in     different ways to stop tumor cells from dividing so they stop growing or die. Giving     ixabepilone with ketoconazole may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving     ixabepilone together with ketoconazole and to see how well they work in treating patients     with advanced solid tumors.   "
172206|NCT00096330|"     RATIONALE: Chemoprevention therapy is the use of certain agents to try to prevent the     development of cancer. The use of folic acid may be effective in preventing colorectal     cancer. Eating a diet rich in folic acid may prevent the development of colorectal cancer.      PURPOSE: This randomized phase I trial is studying how well a folate-depleted diet works     compared to a folate-supplemented diet in preventing colorectal cancer in patients who are at     high risk for developing colorectal cancer.   "
172207|NCT00096343|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy     before surgery may shrink the tumor so that it can be removed. Combining paclitaxel with     carboplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin     works in treating women who are undergoing surgery for newly diagnosed, locally advanced     breast cancer.   "
172208|NCT00096356|"     RATIONALE: Coenzyme Q10 is a vitamin that may be effective in relieving fatigue and     depression in women who are undergoing chemotherapy for breast cancer.      PURPOSE: This randomized clinical trial is studying how well coenzyme Q10 works in relieving     treatment-related fatigue in women with breast cancer.   "
172209|NCT00096369|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of tamoxifen may be effective in preventing     breast cancer.      PURPOSE: This randomized phase II trial is studying tamoxifen to see how well it works     compared to placebo in preventing breast cancer in women who are at increased risk for the     disease.   "
172210|NCT00096382|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Radiation     therapy uses high-energy x-rays to damage tumor cells. Biological therapies, such as cellular     adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor     cells from growing. Autologous stem cell transplant may be able to replace immune cells that     were destroyed by chemotherapy and radiation therapy. Interleukin-2 may stimulate a person's     lymphocytes to kill tumor cells. Combining chemotherapy, radiation therapy, and biological     therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine     together with radiation therapy followed by cellular adoptive immunotherapy, autologous stem     cell transplant, and interleukin-2 works in treating patients with metastatic melanoma.   "
172212|NCT00096408|"     The primary objective of this study is to assess disease-free survival at 4.5 years     postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who     are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are     randomised to receive Total Abdominal Hysterectomy (TAH).   "
172213|NCT00096421|"     The purpose of this study is to evaluate the impact of tight control of serum glucose levels     with an intensive insulin treatment in patients hospitalized in an intensive care unit with     medical and surgical patients.   "
172214|NCT00096434|"     This phase II trial is studying how well sorafenib works in treating patients with metastatic     breast cancer. Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary     for their growth and by stopping blood flow to the tumor.   "
172215|NCT00096447|"     This phase II trial is studying how well lapatinib works in treating patients with recurrent     or persistent endometrial cancer. Lapatinib may stop the growth of tumor cells by blocking     the enzymes necessary for their growth   "
172216|NCT00096460|"     This study is designed as a Phase II/III, multi-center trial, comparing two transplant     strategies to determine whether non-myeloablative allogeneic Hematopoietic Stem Cell     Transplantation (HSCT) will improve long-term progression-free survival compared to     autologous HSCT. Recipients will be biologically assigned to the appropriate treatment arm     depending on the availability of a Human Leukocyte Antigen (HLA) matched sibling.   "
172217|NCT00096473|"     Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to     moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking     abilities, activities of daily living and global function in patients. The purpose of the     study is to further investigate the effectiveness and safety of donepezil in patients with     severe Alzheimer's disease.      Donepezil is thought to work in the brain by increasing the levels of an important brain     chemical called acetylcholine. This chemical helps a person's memory to work better.   "
172218|NCT00096486|"     RATIONALE: Gefitinib and everolimus may stop the growth of tumor cells by blocking the     enzymes necessary for their growth. Giving gefitinib together with everolimus may kill more     tumor cells.      PURPOSE: This phase I/II trial is studying the side effects, best way to give, and best dose     of giving gefitinib with everolimus and to see how well it works in treating patients with     stage IIIB or stage IV or recurrent non-small cell lung cancer.   "
172219|NCT00096499|"     Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells     from dividing so they stop growing or die. This phase II trial is studying how well SB-715992     works in treating patients with metastatic prostate cancer that did not respond to docetaxel     or paclitaxel   "
172220|NCT00096512|"     Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their     growth. It may also stop the growth of tumor cells by stopping blood flow to the tumor. This     phase II trial is studying how well sorafenib works in treating patients with recurrent or     metastatic head and neck cance   "
172221|NCT00096525|"     RATIONALE: Biological therapy such as lenalidomide use different ways to stimulate the immune     system and stop tumor cells from growing. It may also stop the growth of tumor cells by     stopping blood flow to the tumor.      PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients     with advanced or unresectable kidney cancer.   "
172222|NCT00096538|"     RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and     may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts     against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma.      PURPOSE: This clinical trial is studying how well valganciclovir works in treating patients     with classic non-HIV-associated Kaposi's sarcoma.   "
172236|NCT00096733|"     There are two principal purposes of this study: 1) to determine whether it is more beneficial     for a liver transplant recipient candidate to pursue a living donor liver transplant (LDLT)     or wait for a deceased donor liver transplant (DDLT), and 2) to study the impact of liver     donation on the donor's health and quality of life.   "
172237|NCT00096746|"     This study will compare the response of subjects who failed a first-line ATV-containing     regimen and who have the 150L-containing virus to subsequent protease inhibitor     (PI)-containing therapy with that of a cohort who has failed a first-line reverse     transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.   "
172238|NCT00096759|"     The purpose of this study is to compare the effectiveness of relaxation therapy and tai chi     in treating the symptoms of rheumatoid arthritis (RA).   "
172239|NCT00096772|"     The purpose of this study is to collect blood samples from HIV infected individuals for use     in future genetic studies.   "
172240|NCT00096785|"     The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV)     compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an     antiviral medicine.   "
172241|NCT00096798|"     The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid     (ethyl-EPA), an omega-3 fatty acid, in treating depression.   "
172245|NCT00096850|"     Rifampin (RIF) is used for the treatment of tuberculosis (TB), an infectious disease that     affects many people with HIV. RIF was shown to lower concentrations and decrease the     effectiveness of some anti-HIV drugs, including the HIV protease inhibitor (PI) atazanavir     (ATV) boosted with ritonavir (RTV). The purpose of this study is to determine the     interactions between RTV-boosted ATV and evaluate the safety and tolerability of giving these     drugs together in HIV uninfected adults.   "
172263|NCT00097097|"     Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two     cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential     Newborn Care Program compared to the new World Health Organization (W.H.O.) basic perinatal     care education of health care providers (Essential Newborn Care Program) results in reduced     mortality due to perinatal asphyxia.   "
172264|NCT00097110|"     The perinatal morbidity and mortality rates for Brazil are five to ten-fold higher than those     reported for upper income countries. This study tests the likelihood that the joint     administration of antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the     incidence of preeclampsia among chronically hypertensive pregnant patients and patients with     a past history of preeclampsia/eclampsia.   "
172223|NCT00096551|"     Background:        -  Pox viral vectors can induce a PSA-specific T-cell responses and clinical responses in          patients with advanced prostate cancer.        -  Intratumoral vaccines of recombinant fowlpox vectors appear to be more potent in          inducing antitumor effects than the s.c. route of administration, especially when the          recombinant rF-vector given intratumorally is preceded by a rV-recombinant given s.c.          This may be due to:        -  Making the tumor cell an antigen presenting cell via upregulation of both antigen          (signal 1) and costimulatory molecules (signal 2).        -  Making the tumor cell more susceptible to killing via upregulation of ICAM.        -  The increased expression of perforin in peptide-specific T cells that came into contact          with the TRICOM-infected targets.        -  Potentially allowing the immune system to select for other tumor encoded antigens to          generate a polyvalent immune response.      Objectives:        -  1: Safety and feasibility of an intraprostatic vaccine strategy.        -  2: To assess the change in PSA-specific T-cell response as measured by ELISPOT assay.        -  2: To evaluate T-cell infiltration histologically in patients who have pre- and          post-vaccine prostate biopsies.      Eligibility:        -  Must have either a) biopsy proven, locally recurrent prostate cancer following local          radiation as defined by the ASTRO consensus criteria as 3 consecutively rising PSA          levels or b) have refused or not be candidates for local definitive therapy (surgery or          radiation therapy) and have clinically progressive disease on androgen deprivation          therapy (eg. three increases in PSA over nadir, separated by at least one week). For          patients with previous RT, the biopsy confirming local recurrence must be done at least          18 months after the completion of RT.        -  Since this may also generate a systemic immune response, patients with minimal          extraprostatic disease may be enrolled.        -  Hepatic function: Bilirubin < 1.5 mg/dl, AST and ALT< 2.5 times upper limit of normal      Design:        -  Dose escalation Phase I design. Each cohort will consist of 3-6 patients, with cohorts 4          & 5 restricted to include only HLA-A2 + patients; maximum accrual is 30        -  Patients in all cohorts receive initial priming with rV- PSA(L155)/TRICOM and rF-GM-CSF          s.c.        -  The first two cohorts utilize a booster intraprostatic with dose escalation of          rF-PSA(L155)/TRICOM.        -  Third and fourth cohorts add dose escalations of rF-GM-CSF along with the highest dose          of rF-PSA(L155)/TRICOM        -  Last (5th) cohort u...   "
172224|NCT00096564|"     Objectives: The purpose of this study is to identify areas of brain activation during the     urge to yawn. Little is known about how yawning is suppressed, or why yawning often occurs in     response to seeing another person yawn (contagious yawning). Contagious yawning is similar to     other contagious motor programs, such as the greater urge Tourette subjects feel to tic when     seeing repetitive movements or other subjects' tics, the urge to scratch when discussing     itching and scratching, or the urge to urinate when hearing running water. Hypothetically,     the urge or the suppression of this urge is modulated by a common cortical circuit implicated     in Tourette syndrome. We plan to use functional magnetic resonance imaging (fMRI) to identify     the pattern of blood oxygenation level-dependent (BOLD) activation in the brain when normal     volunteers feel the urge to yawn.      Study Population: We intend to study 25 normal, right-handed, healthy volunteers.      Study Design: Using an event-related design, we will scan subjects, using the same 3T fMRI     scanner, while showing a video of a person yawning, gaping, coughing, or doing nothing. Each     of these four action stimuli will last for four seconds, with varying interstimulus     intervals. Each video set will contain all actions displayed ten times pseudorandomly. Two     data sets will be collected from each subject and will be separated by a brief rest period.     Subjects will be instructed before the scan to watch a videotaped person perform various     behaviors, without detailing the specific actions. So as not to influence their natural     response to the yawning stimulus, we will instruct them only to keep their head still. The     variable of interest will be the activation during urge-generation, contrasted with other     control stimuli. A survey will be administered for informational purposes following the scan     to assess the subjects' general impression of their susceptibility to yawning, whether they     yawned in the scanner, whether they suppressed the urge to yawn, and if the urge to yawn     increased or decreased with the repetition of the yawning segment.      Outcome Measures: The primary outcome of this study is the activation of brain structures in     response to viewing another person yawning. In particular, we are interested in the     activation of the anterior cingulate cortex, parietal operculum, insula, supplementary motor     area, and dorsolateral prefrontal cortex as these are areas implicated in the urge to move in     response to either internal (as in Tourette syndrome) or external (as in itching from     histamine injection) states. Since the urge to yawn is the process of interest, suppression     of yawning is not relevant to the fMRI analysis.   "
172225|NCT00096590|"     RATIONALE: A test that detects abnormal blood clotting in patients with cancer may help     doctors plan cancer surgery.      PURPOSE: This laboratory study is looking at a new blood test to detect abnormal clotting in     patients with metastatic cancer undergoing surgery.   "
172226|NCT00096603|"     This is an open label, multicenter study designed to evaluate the safety and tolerability of     efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with plaque     psoriasis who previously participated in Study ACD2600g.   "
172227|NCT00096616|"     The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled     Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.   "
172228|NCT00096629|"     RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor     cells.      PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine     therapy in treating patients with kidney cancer.   "
172229|NCT00096642|"     Depression is a debilitating illness affecting large numbers of young people. In this study,     children and adolescents ages 10 to 17 meeting criteria for clinical depression will     participate in a 15-session group therapy (cognitive behavioral therapy or CBT) that teaches     strategies for overcoming depressed mood. For half the participants, their parents will also     participate in a parent group. By studying the role of parental involvement, we hope to     develop more effective treatments for depressed children and teens in the future.   "
172230|NCT00096655|"     The purpose of this study is to evaluate the effectiveness and safety of infliximab     (Remicade) in patients with Ulcerative Colitis. Infliximab (Remicade) targets specific     proteins in the body's immune system to help control the development of inflammation to help     reduce painful disease.   "
172231|NCT00096668|"     This is an open label study where each patient will receive TOCOSOL(R) Paclitaxel 120mg/m2     every week for first line treatment of metastatic breast cancer. Patients will be followed to     determine the efficacy of treatment (as measured by objective response rate), and the safety     associated with weekly administration of TOCOSOL Paclitaxel.   "
172232|NCT00096681|"     The purpose of this study is to estimate the amount of HIV and tuberculosis (TB) infection in     individuals 15 years and older in the Masiphumelele township of Cape Town, South Africa. Data     collected in this study will be used to predict the effect of introducing anti-HIV therapy in     this community.   "
172233|NCT00096694|"     Oral contraceptives (OCs) are not a good option for some HIV infected women because of the     potential for drug interactions between OCs and anti-HIV drugs; additionally, OCs may     increase the risk of transmitting HIV to sexual partners. Levonorgestrel is commonly     prescribed as part of a combination OC. An intrauterine device (IUD) is a device inserted in     a woman's uterus to prevent pregnancy. The purpose of this study is to determine the effect     of a levonorgestrel-releasing IUD on the amount of HIV present in an HIV infected woman's     cervix after 4 weeks of IUD use.      Study hypothesis: There will be no increase in genital tract HIV RNA and DNA after placement     of the levonorgestrel IUD.   "
172234|NCT00096707|"     The objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and     biologic effect (FDG PET, preliminary efficacy) of daily oral doses of 2DG with and without     weekly docetaxel in subjects with advanced solid tumors.   "
172235|NCT00096720|"     Study participants who have been clinically diagnosed with Parkinson disease will receive no     treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12     weeks. Over the course of the study subjects will travel to the Institute for     Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.   "
172246|NCT00096863|"     Delirium is associated with increased risk of death, prolonged stay, higher cost of care, and     likely long-term brain deficits in survivors. This form of brain dysfunction occurs in     intensive care unit (ICU) patients in epidemic proportions, and the scope of this problem is     likely to worsen in upcoming years due to the aging of our population and increased     utilization of the ICU. Currently, delirium goes unrecognized and untreated in the vast     majority of circumstances in the ICU unless the patient presents with hyperactive delirium     and agitation. In the latter circumstance, a commonly used typical antipsychotic called     haloperidol is considered the principal agent for treating delirium based largely on     anecdotal evidence to support its usefulness, though no placebo controlled trials exist.     There are no FDA approved medications for delirium. The atypical antipsychotics provide a     promising alternative for the treatment of delirium due to their enhanced beneficial effects     on positive (agitated) and negative (quiet) symptoms proven in mania and schizophrenia,     reduced risk for side effects common to haloperidol such as extrapyramidal symptomatology,     and less potentially lethal heart rhythm disturbances. It is imperative that well-designed     phase II studies to determine proof of principle be conducted. A pilot study of feasibility     to begin assessing the role of antipsychotics in the management of ICU delirium.   "
172247|NCT00096876|"     In this study, individuals complete and return a mail survey, specifically a 40 item scratch     and sniff smell test.   "
172248|NCT00096902|"     This study will examine whether certain procedures that do not involve the use of medications     can reduce symptoms of neurocardiogenic syncope (SIN-ku-pe), or a condition involving     recurrent fainting. This condition is also known as vasovagal syncope or neurally mediated     hypotension. Neurocardiogenic syncope is a disorder of the autonomic nervous system, which     controls automatic body functions such as blood pressure, heart rate, and sweating. That     system can be affected by medications, conditions of the mind or body, and by a person's     surroundings. Researchers in this study wish to learn whether hypnosis, hand exercises,     education, or diary keeping can affect the autonomic nervous system and improve symptoms of     neurocardiogenic syncope.      Patients age 18 or older who have neurocardiogenic syncope may be eligible for this study.     Those who have a medical illness making it unsafe to participate, who cannot discontinue     certain medications, or who are pregnant are not eligible. Patients will undergo a medical     history and physical examination, complete a questionnaire, and experience Valsalva and tilt     table tests. These tests will take about 5 hours during 1 to 2 days.      The Valsalva test evaluates some of the reflexes of autonomic nervous system. Patients will     lie flat on a padded table and have sensors placed on the body, to measure blood pressure,     breathing rate, and other functions. They will blow into a sterile tube for 12 seconds while     the body's responses are measured. The procedure may need to be repeated several times.     During the test, an intravenous tube, guided by a needle, will be placed in the patient's     arm. The tube will be used to collect samples of blood (less than 7 tablespoons) to measure     chemicals such as adrenaline. For the tilt table test, a patient will lie on a padded,     motorized table and have sensors placed on the body. Velcro straps will be placed around the     patient's body to help hold him/her on the table. Then the table will tilt the patient from a     flat position to an upright one in about 10 seconds. The patient will stay upright for 45     minutes while symptoms are monitored, measurements are taken, and blood samples are collected     through the intravenous tube. Then the table will be returned to the flat position. If the     patient faints or is about to faint, or if he or she has an unsafe heart rhythm before the 45     minutes is over, the test will be stopped and the table will be returned to the flat     position. Symptoms will be treated as needed.      Patients who qualify for further study will then become familiar with hypnosis and be     evaluated for their natural ability for experiencing it. A professionally trained doctor will     guide patients into a hypnotic state, and patients will be asked to respond to various     suggestions. They will be videotaped, an activity that will require a separate consent form.     Following these procedures, patients will be assigned to one of the four groups in this     study. Those in the hypnosis group will have weekly sessions for 6 weeks, with each session     lasting about 1-1/2 hours. The education group will meet a study investigator for learning     about syncope and the autonomic nervous system, with each session lasting about 1-1/2 hours     once a week for 6 weeks. The hand exercise group will be taught certain hand exercises to     perform, at home and as instructed, for 6 weeks. The diary group will receive instructions on     keeping a diary pertaining to their condition, at home, for 6 weeks. After 6 weeks, patients     will return for an evaluation to include completion of questionnaires and another tilt table     test and blood collection by intravenous tube. This entire study will take about 8 weeks.     There may be direct benefits from participating in this study. The experimental procedures     may help patients' neurocardiogenic syncope.      After completing this study, patients will be offered any or all of the experimental     procedures tested in this study upon their request and at the discretion of the principal     investigator. For example, a patient who is assigned to the diary group may be offered     hypnosis, education, and hand exercise instruction after completion of the study.   "
172249|NCT00096915|"     The proposed study is designed to test a novel dosing paradigm that would facilitate the     treatment of anemia in CKD patients on dialysis. Anemic patients on hemo and peritoneal     dialysis who have achieved and maintained target hemoglobin (Hb) on every other week (Q2W)     dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM)     dosing.   "
172250|NCT00096928|"     This was a multicenter, prospective, 5-year surveillance study of approximately 5000     Raptiva-treated patients and approximately 500 non-Raptiva treated patients (formerly 2500     comparison patients who were treated with a biologic therapy other than Raptiva) with chronic     moderate to severe plaque psoriasis who were candidates for treatment with Raptiva.   "
172251|NCT00096941|"     This is a multicenter, open label extension study. Subjects who have completed treatment in     the parent study of pertuzumab, either alone or with a combination agent, and who received at     least one dose of pertuzumab in the parent study are eligible for inclusion in this trial if     they are continuing to receive clinical benefit.   "
172252|NCT00096954|"     This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study     that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had     elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1     second (FEV1) ≥ 80% predicted, and were on inhaled corticosteroids with or without other     controller asthma medications (e.g., long-acting β2-agonists [LABAs], leukotriene receptor     antagonist [LTRA], or immunotherapy).   "
172253|NCT00096967|"     This is a multicenter, open-label extension study. Subjects who have received rhuMAb VEGF     therapy in Study AVF2107g, AVF2119g, or AVF2192g and who completed the parent study are     eligible for inclusion in this trial. Subjects who have received placebo in Study AVF2107g or     AVF2192g are also eligible.   "
172254|NCT00096980|"     This study is an open label, randomized, multicenter study designed to compare the efficacy     of 12 weeks of subcutaneously administered efalizumab (monotherapy) with that of combination     therapy (Efalizumab and a topical corticosteroid ointment) in subjects with moderate to     severe plaque psoriasis who are candidates for systemic therapy. The study will also evaluate     the safety and tolerability of 30 months of continuous efalizumab treatment in those subjects     who derive benefit from the initial 12 weeks of treatment.   "
172255|NCT00096993|"     This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial     of pertuzumab in combination with gemcitabine relative to placebo in combination with     gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer     that is resistant to platinum-based chemotherapy.   "
172256|NCT00097006|"     To conduct epidemiological, laboratory, and survey research on volunteer blood donors within     the United States to ensure the safety and availability of the United States' blood supply.   "
172257|NCT00097019|"     This is an open-label, single-arm, two-stage, multicenter Phase II study evaluating the     efficacy and safety of bevacizumab in women with platinum resistant, advanced (Stage III or     IV) EOC (epithelial ovarian cancer) or PPC (primary peritoneal cancer) that subsequently     progressed either during treatment with Doxil or Hycamtin therapy or within 3 months of     discontinuing treatment with Doxil or Hycamtin therapy.   "
172258|NCT00097032|"     The purpose of this study is to determine whether the sedating (causing sleepiness) effects     of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize,     remember, judge, and reason) functioning in subjects with stable Bipolar I Disorder.   "
172259|NCT00097045|"     This study is designed to compare the safety, tolerability and antiviral effects of omega     interferon administered alone to omega interferon administered with ribavirin in the     treatment of subjects with chronic Hepatitis C virus (HCV) infection.   "
172260|NCT00097058|"     This study is designed to assess the effects of estrogen therapy among postmenopausal women     at risk for cognitive decline.   "
172261|NCT00097071|"     This trial is conducted in the United States of America (USA). It is demonstrated that     intensive insulin therapy resulting in good glycaemic control can reduce or delay the     incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an     ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin     injection (CSII) therapy in the pediatric and adolescent age population. This trial compares     the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered     by CSII in children and adolescents with type 1 diabetes.   "
172262|NCT00097084|"     This trial is conducted in Europe and the United States of America (USA). The purpose of this     study is to test whether insulin detemir is a safe and at least as effective alternative to     insulin glargine for the control of blood glucose in basal/bolus therapy in patients with     type 2 diabetes.   "
172425|NCT00089908|"     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and     subtropical regions of the world. The purpose of this study is to test the safety of and     immune response to a new dengue virus vaccine in healthy adults.   "
172265|NCT00097123|"     Death rates for pregnant women in rural India are approximately forty-five times higher than     in the United States. Bleeding after the birth of a child and underlying anemia are the     primary causes of mothers' deaths and sickness in rural India. This study assesses the     effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the     incidence of maternal bleeding following births assisted by midwives in selected sites in     Belgaum District, Karnataka, India.   "
172266|NCT00097149|"     Cleft lip and palate are a significant component of morbid human birth defects in the     developing world. This study measures the impact of having a child born with a cleft lip on     subsequent maternal/infant family health, and whether frequent pediatric care compared to     standard pediatric care will reduce neonatal mortality in children born with cleft lip and     palate.   "
172267|NCT00097162|"     This study will examine whether direct current (DC) polarization (electrical stimulation) of     the visual cortex can cause a temporary improvement of vision in an amblyopic eye of an     adult. Amblyopia (also called lazy eye) is reduced vision in an eye, caused by abnormal brain     processing of visual information. In amblyopia, the visual cortex (the part of the brain that     processes visual information) favors the other eye and suppresses the image from the     amblyopic eye.      Amblyopia in children is treated by patching or blurring the good eye, which forces the child     to use the amblyopic eye and overcome suppression by the brain. This treatment only works in     children 8 years old and younger, however. Electrical stimulation of the brain can     temporarily change the function of the visual cortex in adults with good vision, but its     influence on the visual function of people with amblyopia is unknown. If DC polarization can     improve vision in amblyopic eyes in adults, it would show that the visual cortex is still     plastic, and it might help researchers develop a treatment for adults with amblyopia in the     future.      Patients 18 years of age and older with amblyopia caused by crossing in or turning out of the     eyes in childhood or by a difference in near- or farsightedness between the eyes may be     eligible for this study. Candidates are screened with a medical history and complete eye     examination, including a glaucoma screening and checks of vision, in- or out-turning of the     eyes, depth perception, need for glasses, and the interior structures of the eyes.      Participants undergo two study sessions, scheduled at least 24 hours apart, involving the     following procedures:        -  Examination: Before each session, the patients' distance vision, contrast sensitivity          (ability to see fading letters), and ability to read small print are checked in both          eyes.        -  DC polarization: Patients receive either 20 minutes of electrical stimulation or 20          minutes of sham stimulation (each patient will receive both electrical and sham          stimulation on different days).        -  Repeat examination: Immediately after the stimulation and again 20 minutes later,          patients undergo repeat visual function testing. Those who show any differences in          visual function 20 minutes after the stimulation are examined again 1 hour after the          stimulation. Patients in whom the effect continues after 1 hour are examined again after          1 week.   "
172268|NCT00097175|"     This study will investigate how the brain process emotions in healthy people and in patients     who have major depression in order to better understand the causes of depression. It will     examine what happens in the brain when a person responds to words related to different     emotions while the brain's ability to manufacture a chemical called serotonin is reduced.     Serotonin regulates functions such as emotion, anxiety and sleep, and stress hormones such as     cortisol. In this study, participants' serotonin levels are reduced by depleting tryptophan,     an amino acid that is the main building block for serotonin.      Healthy volunteers and patients with major depression that has been in remission for at least     3 months may be eligible for this study. Candidates must be between 18 and 50 years of age     and right-handed. They are interviewed about their medical and psychiatric history, current     emotional state and sleep pattern, and family history of psychiatric disorders. Screening     also includes psychiatric interviews and rating scales, neuropsychological tests, physical     examination, electrocardiogram (EKG), and blood, urine, and saliva tests. Women have their     menstrual phase determined by a blood test and home urine ovulation test kit.      The study involves two clinic visits in which participants undergo tryptophan depletion and     magnetic resonance imaging (MRI). Subjects arrive at the NIH Clinical Center in the morning     after fasting overnight. They fill out questionnaires have a blood sample drawn, and then     take 74 capsules that contain a mixture of amino acids found in the diet. At one visit they     are given capsules that contain a balanced mixture of amino acids one would normally eat in a     day; at the other visit, some of the capsules contain lactose instead of tryptophan, causing     tryptophan depletion. At 2 p.m. participants fill out the same questionnaires they completed     at the beginning of the day and have another blood sample drawn. Then they do a computerized     test in the MRI scanner. MRI uses a magnet and radio waves to obtain pictures of the brain.     For the test, subjects lie on a narrow bed that slides into the cylindrical MRI scanner. They     are asked to press a button in response to words associated with different emotions that     appear on a screen. Arterial spin labeling - a test that uses magnetism to measure blood flow     in different areas of the brain-is also done during the procedure. After the scan, subjects     eat a meal and then return home.      DNA from the participants' blood samples is also examined to try to better understand the     genetic causes of depression. Some of the white cells from the samples may also be grown in     the laboratory so that additional studies can be done later.   "
172269|NCT00097188|"     This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicenter     study to evaluate the safety and efficacy of Rituximab in adults with RRMS.   "
172270|NCT00097214|"     This is a phase II study in previously untreated subjects with histologically or     cytologically proven stage IIIB/IV NSCLC designed to determine the efficacy of first line     treatment with carboplatin and cetuximab.   "
172271|NCT00097227|"     The purpose of the study is to determine if the combination of cetuximab, carboplatin and     paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer     (NSCLC). The safety of this combination will also be evaluated.   "
172272|NCT00097240|"     The Raptiva Pregnancy Registry was a prospective observational study established to obtain     data on pregnancy outcomes of women who were exposed to Raptiva.   "
172273|NCT00097253|"     The purpose of this study is to examine the body's response to relaxing and stimulating     fragrances commonly used in aromatherapy.   "
172274|NCT00097266|"     The purpose of this research study is to confirm the safety and effectiveness of aripiprazole     therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.   "
172275|NCT00097279|"     This trial is conducted in the United States of America (USA). The purpose of this study is     to test whether biphasic insulin aspart 70/30 is a safe and at least as effective alternative     in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for     the control of blood glucose.   "
172601|NCT00102375|"     The purpose of this study is to determine whether the triple combination of Carboplatin,     Paclitaxel and Topotecan has a superior clinical outcome in the treatment of ovarian cancer     compared with the combination of Carboplatin and Paclitaxel.   "
172321|NCT00088465|"     This is a long-term, open-label clinical study designed to enable longer-term treatment of     patients completing other clinical studies with intramuscular olanzapine depot.      Key objectives of the study are to:        -  Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,        -  Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,        -  Determine the blood levels of IM olanzapine depot in patients during long-term treatment   "
172322|NCT00088478|"     Key objectives of this clinical study are to:        -  Determine how well intramuscular (IM) olanzapine depot works compared to placebo        -  Evaluate the safety and tolerability of IM olanzapine depot compared to placebo        -  Evaluate different doses of IM olanzapine depot compared to placebo to identify the best          dose(s).   "
172426|NCT00089921|"     The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients     with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic)     disease-modifying anti-rheumatic drugs (DMARDs).   "
172276|NCT00097292|"     RATIONALE      The accrual of data from the laboratory and from epidemiologic and prevention trials has     improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus     (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and     characterization of the early metabolic abnormalities in T1DM is steadily increasing.     However, information regarding the natural history of T1DM remains incomplete. The TrialNet     Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been     designed to clarify this picture, and in so doing, will contribute to the development and     implementation of studies aimed at prevention of and early treatment in T1DM.      Purpose:      TrialNet is an international network dedicated to the study, prevention, and early treatment     of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland,     United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to     testing new approaches to the prevention of and early intervention for type 1 diabetes.      The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to     enhance our understanding of the demographic, immunologic, and metabolic characteristics of     individuals at risk for developing type 1 diabetes.      The Natural History Study will screen relatives of people with type 1 diabetes to identify     those at risk for developing the disease. Relatives of people with type 1 diabetes have about     a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet     will identify adults and children at risk for developing diabetes by testing for the presence     of these antibodies in the blood. A positive antibody test is an early indication that damage     to insulin-secreting cells may have begun. If this test is positive, additional testing will     be offered to determine the likelihood that a person may develop diabetes. Individuals with     antibodies will be offered the opportunity for further testing to determine their risk of     developing diabetes over the next 5 years and to receive close monitoring for the development     of diabetes.   "
172277|NCT00097305|"     The purpose of this study is to examine and compare the effects of two body therapy     approaches in women who have experienced child sexual abuse.   "
172278|NCT00097318|"     This study will examine the safety of the drug interferon beta 1a in patients with acute     ischemic stroke to determine the highest dose patients can tolerate without serious side     effects and to determine the best way to give the medication. Ischemic stroke is caused by a     blood clot blocking the flow of blood to brain tissue, causing loss or impairment of bodily     functions governed by the affected part of the brain. Interferon beta 1a is approved for use     in patients with multiple sclerosis to prevent further brain injury caused by inflammation;     the drug may also help prevent further brain injury in patients with acute stroke.      Patients between 18 and 85 years of age who have had a stroke and who can begin taking the     study drug within 24 hours of onset of stroke symptoms may be eligible for this study.     Candidates are screened with a medical history, physical examination and neurological     examinations, blood tests, electrocardiogram, and brain imaging with magnetic resonance     imaging (MRI) or computed tomography (CT) scans.      Participants are randomly assigned to receive either interferon beta 1a or placebo (an     inactive substance). For every five patients enrolled, four receive the study drug and one     receives placebo. The dose of interferon beta 1a is increased in successive groups of     patients, so that the first group to enter the study receives 11 micrograms (mcg) of the     drug, the next receives 22 mcg, then 44 mcg, 66 mcg, and 88 mcg. All patients receive their     first dose intravenously (through a vein); additional doses are given subcutaneously (under     the skin).      During their hospital stay all participants receive standard medical care for stroke, have     neurological checks every 6 hours, and have continuous heart monitoring. To prevent fever,     they receive medication, such as Tylenol, before each dose of interferon beta 1a or placebo     and every 6 hours as needed while taking the study drug. Routine blood tests are done at 3     and 7 days after the first dose of study drug (or at discharge if the patient leaves the     hospital before 7 days) and again at 14, 21, and 28 days. Neurological examinations are done     24 hours after starting the study medication, then every day for 14 days, and again on day     28.      After discharge from the hospital, patients are seen by a nurse every day foan 14 days after     the first medication dose. They are contacted by phone on days 17 and 21. On day 28 they     return to the hospital as an outpatient for a neurological assessment and blood tests.   "
172279|NCT00097331|"     The study will evaluate the effectiveness and safety of the investigational drug SB683699 in     treating patients with relapsing multiple sclerosis (MS), using data from magnetic resonance     imaging (MRI) scans as the main measure.   "
172280|NCT00097344|"     The purpose of this study is to determine whether maximal estrogen suppression achieved via     the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene     (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying     the growth of breast cancer, and whether the side effects of the combined hormonal therapy     are different from the side effects of letrozole.   "
172281|NCT00097357|"     The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and     lungs in men and women following unilateral total knee replacement surgery. The safety of     this treatment will also be studied.   "
172282|NCT00097370|"     This is an open label study of mepolizumab 750 mg intravenous in those subjects who     participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in     subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing     frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs     and symptoms of Hypereosinophilic Syndrome.   "
172283|NCT00097383|"     This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in     combination for locally advanced or metastatic breast cancer. Epirubicin is a     well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been     combined with other drugs but they have not yet been combined with each other. It is expected     that the patient will benefit from the different mechanisms of action of the two drugs.   "
172284|NCT00097396|"     The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule     of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular     (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to     evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in     healthy volunteers who have previously been vaccinated with the same concentration of rF1V     vaccine.   "
172285|NCT00097409|"     The purpose of this study is to determine how effective and safe a new investigational drug     is in treating persistent or recurrent ovarian cancer in patients who have received a     platinum/taxane based chemotherapy and whose disease continues to progress. The treatment     involves a 1-hour treatment given intravenously (IV), and repeated once every 21 days. A     patient may continue to receive the treatment as long as they are benefiting from the     treatment. Blood samples will be taken at specific times over a 24 hour period to measure the     amount of drug in your body at specific times after the drug is given. Blood samples will     also be taken for routine lab tests such as complete blood counts and clinical chemistries.     Physical exams will be performed before each treatment.   "
172286|NCT00097422|"     The purpose of this study is to investigate the safety and perform preliminary clinical     evaluation in patients with mild to moderate CDAD.   "
172287|NCT00097435|"     This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety,     tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to     respond to previous interferon alfa therapy.   "
172288|NCT00097448|"     This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected     into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing     loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).   "
172304|NCT00097656|"     The purpose of this study is to determine whether maternal periodontal therapy (tooth     cleaning) decreases the rate of preterm deliveries at <37 weeks gestation and to determine     the effects of maternal periodontal therapy on the birth weight of infants born less than 37     weeks gestation.   "
172289|NCT00097461|"     This study will explore ways in which employee benefits may be designed to improve people's     health, through examining the viewpoints and preferences of low-income people. A person's     health is affected not only by being able to receive health care but also by several factors     such as income and education. People with lower incomes have been found to be not as healthy     as those with higher incomes. While the governments of many countries in the Organization for     Economic Cooperation and Development are currently working on public policy to address this     topic, the likelihood is small that the United States, given its market-based economy, will     do the same. However, owing to the heavy reliance in the United States on employer-sponsored     health insurance, it would be useful to explore the possibility of insuring some of the     measures that people can take to improve their health, and to do that through employee     benefit packages. Solutions might include extended unemployment insurance, more education,     job training, exercise programs, help for housing, disability insurance, and extra retirement     benefits.      Adults who have a minimum of a sixth-grade reading level, have low incomes, are English     speaking may be eligible for this study. For recruitment, 400 people who live and work in the     Washington, D.C, area will be invited to participate, and about12 people will take part in     each session. Unless people in the study participate during working hours, they will each be     paid $75 at the conclusion of the session.      The study consists of one phase, in which participants will engage in a group exercise that     lasts for approximately 2-1/2 hours. During that time, participants will have the chance to     say what employee benefits they would choose, if the opportunity arose, to improve their     health. They will first make those choices by themselves and then make choices along with     other people in the group. While group members talk, the discussion will be recorded on a     tape recorder. Participants will be asked to give information about themselves and their     opinions but will not be asked for any information that identifies them personally, except     for data needed to pay participants with a paycheck. They will also get to use a computer and     will be shown how to use it, if necessary. If videotaping or photographs are done during the     exercise, the investigators of the study will ask for separate signed permission to do so.     Participants will be asked to respect the privacy of others in the group and to not discuss     the opinions of others after leaving the session.   "
172290|NCT00097474|"     This study will examine the effects of cortisol (hydrocortisone), melatonin, a combination of     cortisol and melatonin, and placebo (an inactive substance) on jet lag symptoms. Jet lag is a     term used to describe symptoms people commonly experience after rapid travel across several     time zones. The cause of jet lag is not known, but various hormones, including cortisol and     melatonin, have a day-to-night pattern of secretion and play a role in maintaining the body's     internal rhythms. This study will test whether taking cortisol, melatonin, or both can help     re-establish the body's day-night cycle and result in less jet lag.      People between 18 and 65 years of age who are planning a non-stop eastward flight with the     following characteristics may be eligible for this study:        -  Crossing six to eight time zones (6 to 8 hours difference between Eastern Standard Time          and the destination)        -  Destination between 30 and 50 latitudes (approximately Cairo to London)        -  Evening flight (5 PM to midnight) with morning arrival        -  Remaining abroad at least 4-10 days      Candidates must have a body mass index (BMI) between 20 and 30 kg/M (not too thin and not     overweight) and must not be taking medicines that affect sleep or cortisol or melatonin     levels. Prospective participants are screened with a medical history, blood tests, and check     of blood pressure, height, and weight.      Pre-flight Procedures      Participants keep a sleep journal 3 days before the flight. For 1 day within 3 days of the     flight they fill out jet lag and sleepiness questionnaires and collect morning and bedtime     saliva samples for measurement of cortisol and melatonin. The saliva is collected by chewing     on two small cotton pads and spitting them into a tube. Premenopausal women provide a urine     sample the week before the flight to test for pregnancy. On the day of the flight, the     participants do not collect saliva or fill out sleep logs or questionnaires. They are given     two bottles with study medication. One bottle, labeled AM, contains either hydrocortisone     or placebo; the other, labeled PM, contains either melatonin or placebo.      Post-flight Procedures      Upon arriving at their destination in the morning, participants obtain a saliva sample and     take one of the capsules in the AM bottle. At bedtime, they collect saliva and then take     one of the PM capsules. They repeat the medication doses for a total of 4 days and repeat     the saliva collections on days 2 through 4, 7 and 10 after arrival. In addition, participants     complete jet lag and sleep questionnaires in the morning, afternoon, and just before bedtime     on the day of arrival and on days 2 through 4, 7 and 10.      After they return from their trip, participants are seen at the NIH Clinic to bring in their     saliva specimens and review their questionnaires with study investigators.   "
172291|NCT00097487|"     This study is a Phase IV, prospective, nonrandomized, community-based study of clinical     outcomes in patients with metastatic breast cancer treated with Herceptin and a taxane.   "
172292|NCT00097500|"     This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide     and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2     diabetes mellitus using metformin.   "
172293|NCT00097513|"     This study is a multicenter, open-label, observational, postmarketing surveillance study that     will collect information on the use of Genentech GH preparations to treat GH-deficient     subjects with optimal GH dosing during puberty.   "
172294|NCT00097526|"     This study is a multicenter, open-label, postmarketing surveillance study. The substudy will     collect information on BMD in adolescents and young adults with GHD or Turner syndrome who     are completing GH treatment for statural indications.   "
172295|NCT00097539|"     The purpose of this multicenter, open-label, observational, post-marketing surveillance study     is to collect long term safety and efficacy information on growth hormone (GH) products:     Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ     (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) in the     treatment of pediatric growth disorders for which GH is prescribed.   "
172296|NCT00097552|"     This study is a multicenter, open-label, observational, postmarketing surveillance study of     Genentech growth hormone (GH) products in the treatment of girls with Turner syndrome in the     United States and Canada.   "
172297|NCT00097565|"     This is a prospective, observational, longitudinal, multicenter study of patients with newly     diagnosed follicular Non Hodgkin's Lymphoma (NHL) designed to delineate differences in     clinical outcome by comparing the effectiveness and safety of common treatment regimens.   "
172298|NCT00097578|"     This is an observational study designed to follow patients with metastatic or locally     advanced and unresectable colorectal cancer who are receiving Avastin in combination with     chemotherapy and whose cancer has been either previously untreated or treated <=4 months     prior to enrollment.   "
172299|NCT00097591|"     The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as     a possible treatment for patients with acute coronary syndrome (heart attack or chest pain)     who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a     balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is     better at reducing deaths, future heart attacks, or stroke.   "
172300|NCT00097604|"     The purpose of this study is to examine the way valerian, an herbal sleep agent, is absorbed     and distributed in the body. This study will also compare the effects of valerian after 1     week versus after 2 weeks.   "
172301|NCT00097617|"     This study is a multicenter, open-label, observational, postmarketing surveillance study that     will collect information on the use of Genentech growth hormone (GH) preparations to treat     children with CRI in the United States.   "
172302|NCT00097630|"     The purpose of this study is to determine the impact of a new RN/RRT (Registered     Nurse/Registered Respiratory Therapist) directed 2-step protocol to wean patients off of a     ventilator. This protocol involves daily attempts to halt sedation (spontaneous awakening     trials) combined with daily assessments of patients while they are breathing on their own     (spontaneous breathing trials).   "
172305|NCT00097669|"     The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary     stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug,     B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk     factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial     infarction) and vascular death in patients with recent stroke or transient ischemic attack     (TIA). All patients presenting to one of the participating neurologists or general physicians     within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible     for this trial. Eligible patients will be randomized in a double-blind fashion to receive     multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event     stroke, myocardial infarction, or death from any vascular cause, whichever occurs first.     Our target is to recruit a total of 8,000 patients over the next two years with a median     follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to     continue until December 2005. We aim to complete final follow-up by the end of 2006. However,     the Steering Committee will be flexible in dictating the need for ongoing recruitment and     continuing follow-up, depending on the overall rate of the primary outcome event in the     entire cohort at each interim analysis.   "
172306|NCT00097682|"     This study will explore what research patients understand about financial collaborations in     the research setting and their concerns about these collaborations. Financial partnerships     are crucial to advancing medical research; however, they are giving rise to increasing     concerns about financial conflicts of interest and possible impacts on the integrity of     research and patient safety. This study will examine patients' views about financial ties     between drug companies and the doctors running research studies, as well as ties between the     drug companies and the cancer centers where the studies are conducted.      Patients 18 years of age and older who are enrolled in cancer studies at the National Cancer     Institute in Bethesda, MD; the Fred Hutchinson Cancer Research Center in Seattle, WA; the     Dana-Farber Cancer Institute in Boston, MA; the Columbia Comprehensive University Herbert     Irving Cancer Center in New York, NY; and the University of Colorado Cancer Center in Denver,     CO, may be eligible for this study.      Participants are interviewed about the following:        -  Patients' awareness and understanding about individual and institutional financial          conflicts of interest, and how such conflicts, if they exist, are being managed        -  The impact of a researcher's financial ties on the patient's decision to participate in          that researcher's study        -  The impact of the institution's financial ties on the patient's decision to participate          in research at that institution        -  Attitudes about policies and practices regarding conflicts of interest in the research          setting        -  Attitudes about disclosure of conflicts of interest in the research setting        -  Patient symptoms and performance        -  Patient's cancer trial        -  Patient's cancer history        -  Patient's trust        -  Patient demographics (gender, age, race, religion, education, income, health insurance,          employment).   "
172307|NCT00097695|"     The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin     antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with     hereditary angioedema (HAE).   "
172308|NCT00097708|"     The purpose of this study is to determine whether an experimental anti-anxiety medication is     effective in the treatment of Generalized Anxiety Disorder.   "
172309|NCT00097721|"     The purpose of this study is to determine if E7389 is a safe and effective treatment for     advanced/metastatic breast cancer.   "
172310|NCT00088296|"     This study will examine the effects of morphine on leuteinizing hormone, testosterone,     adrenocorticotropic hormone and cortisol in men. The use of long-term opioids, such as     morphine, to treat patients with pain is increasing, despite a dearth of information about     their effects on hormones. The study will also look at the effect of chronic pain on these     hormone levels and the effect of placebo on pain.      Men between 30 and 65 years of age who have had moderate to severe chronic pain due to     osteoarthritis for at least 3 months and healthy, pain-free men in the same age range may be     eligible for this study. Patients taking an opioid-based medication such as percocet,     vicodin, or morphine for pain relief, as well as patients who are not taking opioids, may     participate. Candidates are screened with a medical history, physical examination, blood     tests, including a blood test to look for possible pain genes, electrocardiogram, x-ray,     and questionnaires that assess the impact of pain on functional level and psychological well     being.      This is a four-part study. Healthy volunteers and patients who are taking opioids for their     arthritis pain end their participation after Part I; those who are not taking opioids     continue with Parts II, III, and IV, as follows:      Part I: Participants are admitted to the NIH Clinical Center at 4 p.m. for an overnight stay.     At 6 p.m. a catheter (plastic tube) is placed in a vein in the forearm and remains in place     throughout the night. Blood samples of 3 cc's each (less than a teaspoon) are collected     through the catheter every 20 minutes for 12 hours, from 8 p.m. until 8 a.m. Participants     also collect their urine starting from 8 a.m. on the morning of hospital admission and     continue the collection throughout their 24-hour hospital stay. Patients are discharged at     the completion of the blood sampling.      Part II: Patients are randomly assigned to take morphine (MS Contin), placebo, or standard     treatment, which consists of anti-inflammatory medications and acetaminophen as needed, but     no opioids. (Patients in groups I and II are also permitted to take anti-inflammatory drugs     and acetominophen, in addition to their study medication.) Patients are monitored for drug     side effects by phone twice a week, and medication doses are adjusted as needed. The morphine     dose is gradually increased over a 4-week period if no side effects develop. After 2 weeks on     the highest dose of morphine, hormone blood levels are measured and patients complete     questionnaires. Patients are readmitted to the hospital for a repeat blood sampling and blood     collection as in Part I. Patients on morphine and placebo are then gradually tapered off drug     over 12 days and remain drug-free for 2 days before starting Part III.      Part III: All patients are given morphine in this part of the study and are monitored for     drug side effects by phone twice a week, with doses adjusted as needed. The morphine is     gradually increased over a 6-week period if no side effects develop and is maintained at the     highest dose for another 8 weeks. Hormone levels are measured and the blood and urine studies     and questionnaires are repeated. Patients interested in continuing long-term treatment with     MC Contin are referred back to their physicians with recommendations to that effect.      Part IV: Patients are followed by phone for 6 months, at which time they return to the     Clinical Center for hormone level measurements, repeat blood and urine tests, and     questionnaires.   "
172311|NCT00088309|"     This study will examine the long-term effects, particularly on bone metabolism, of the drug     tenofovir DF in children with HIV infection. Tenofovir DF is approved for treating     HIV-infected adults, but its use in children has not yet been approved. The drug may be     helpful for children who have been treated with many other drugs and still have detectable     HIV in their blood despite ongoing therapy. In a previous study, many children given     tenofovir DF responded well, with increases in T-cell counts and decreases in viral load.     However, many children also experienced bone thinning. This study will explore the problem of     bone thinning in children taking tenofovir DF in combination with highly active     antiretroviral therapy (HAART).      HIV-infected patients from 4 to 20 years old who are taking tenofovir DF or for whom     tenofovir DF treatment has been recommended may be eligible for this 3-year study.      Participants take tenofovir DF every day in addition to their antiretroviral therapy. They     have frequent follow-up visits for tests and procedures as follows:        -  Study days 0, 2, and 4: blood tests.        -  Screening and every study visit starting day 6: Physical exam, medical history, blood          and urine tests.        -  Baseline and every 48 weeks: Dental and eye examinations, kidney ultrasound, tuberculin          skin testing, chest x-ray, electrocardiogram and echocardiogram, computed tomography          (CT) scan, neuropsychological testing and neurologic assessment.        -  The bone age hand x-rays are done every 24 weeks, unless the growth plates are fused          (i.e. the child has stopped growing)        -  DEXAs are done at 0, 12, 24 weeks and every 24 weeks thereafter. Dual energy x-ray          absorptionometry (DEXA) scan is used to assess bone density. The patient lies still on a          table while the spine and hip are scanned using a small amount of radiation. Only the          spine and hip are scanned in the DEXA scan test.        -  Baseline and week 24: Optional bone biopsy. Some patients are asked to undergo a bone          biopsy to better understand the effect of Tenofovir DF on bone. For the procedure, the          child is given a sedative. The skin over the hipbone is numbed with a small needle, a          small incision is made and a larger needle is inserted into the bone. Some of the bone          tissue is withdrawn through the needle and the incision is closed.        -  Possible lumbar puncture (spinal tap): This optional procedure analyzes cerebrospinal          fluid (CSF), the fluid that bathes the brain and spinal cord. The patient is given a          local anesthetic and a needle is inserted into the space between the bones in the lower          back where the CSF circulates below the spinal cord. A small amount of fluid is          collected through the needle. There is no specific schedule for this procedure if the          patient opts for it.      Patients who are benefiting from tenofovir DF therapy but show signs of bone effects are     offered treatment with pamidronate (Aredia), a drug used to treat hypercalcemia (too much     calcium in the blood). Patients who stop taking tenofovir DF because of bone toxicity     continue to be followed on the regular study schedule. Those who stop the drug for toxicity     other than bone toxicity or for toxicity not related to tenofovir DF are followed every 4     weeks until their laboratory test results improve.   "
172312|NCT00088335|"     This study will identify abnormalities of a protein called alpha synuclein that is found in     the brain of patients with Parkinson's disease and related disorders to see if it can serve     as a disease marker. There is currently no treatment that will cure or delay progression of     Parkinson's disease. Thus, there is a need to find disease markers that can help diagnosis     the disease, follow its progression, and monitor the effects of treatment. This study will     examine and compare alpha synuclein from blood and cerebrospinal fluid (the fluid that bathes     the brain and spinal cord) of patients with Parkinson's disease, patients with variants of     the disease, and healthy normal volunteers to determine differences in the protein that might     serve as a disease marker.      Patients with neurodegenerative disorders such as Parkinson's disease and Parkinson plus     disorders (other diseases that are variants of Parkinson's disease) and healthy volunteers     between 18 and 80 years of age may be eligible for this study. Candidates are screened with a     medical history, physical examination, neurological evaluation, and blood tests. A brain MRI     (magnetic resonance imaging) scan is done if needed for diagnosis.      All participants have a blood sample drawn and a lumbar puncture (spinal tap). For the lumbar     puncture, a local anesthetic is given and a needle is inserted in the space between the bones     in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small     amount of fluid is collected through the needle. The fluid is analyzed for specific proteins     and chemicals that are leaked from the brain in various disease states and that cannot be     measured in blood.      Participation of healthy volunteers is completed after the blood draw and lumbar puncture.     Patients with Parkinson's and related diseases return to the clinic once a year for 2 years     for a repeat blood draw and lumbar puncture to follow changes in the alpha synuclein protein     and to monitor disease progression. Patients with specific proteins of interest may also be     asked to come for a repeat lumbar puncture 6 months after the first procedure.   "
172313|NCT00088348|"     This study will identify patients with anterior segment disease who may be eligible to     participate in current or future NEI studies on this disease. Anterior segment disease     includes all disorders that affect the eye surface, anterior chamber, iris and ciliary body     and lens of the eye. The eye surface is composed of the cornea, conjunctiva, eyelids,     lacrimal and meibomian glands, and the interconnecting nerves.      Patients of any age with anterior segment disease may be eligible for this screening study.     Participants will be evaluated with some or all of the following tests and procedures,     depending on the nature of their eye problem:        -  Medical history and brief physical examination.        -  Eye examination, including measurement of visual acuity (eye chart) and eye pressure,          examination of the pupils, eye movements, structures in the front of the eye (cornea,          conjunctive, etc.), the lens, and the structures in the back of the eye (retinal, optic          nerve, etc.).        -  Photographs of the eye to help assess the status of the cornea and conjunctive and to          evaluate any changes that may occur in the future.        -  Assessment of tear and surface status. The amount of tears the eyes can produce is          measured by placing a small piece of sterile paper in the corner of the eye every 5          minutes. Special orange and green dyes are placed in the eyes to determine the health          status of the surface of the eye.        -  Corneal or conjunctival biopsy. A small tissue sample from the surface of the eye may be          removed for laboratory examination to help diagnose a condition that is unclear. For          this procedure, the eye is numbed with anesthetic eye drops. The required tissue is          collected, an antibiotic ointment is placed in the eye to prevent infection, and a patch          may be placed over the eye for 12 to 24 hours.        -  Blood draw for tests to study the cause of the patient's eye disease.        -  Other diagnostic tests as needed.        -  DNA testing to look for a genetic pattern associated with the patient's eye disease.      Patients who are found eligible for an NEI study will be offered participation in that study.     Patients who are not eligible for current studies will be advised about treatment options.   "
172314|NCT00088361|"     This study will determine how breathing motions may affect positron emission tomography (PET)     scans. It has been discovered that the quality of PET scans varies according to which part of     the breathing cycle patients hold their breath.      NIH Clinical Center patients 12 years of age and older who are scheduled to have PET and     computed tomography (CT) scans as part of their standard medical care may be eligible for     this study.      Participants have their scheduled PET or CT scan as they normally would and are asked to hold     their breath after breathing out, as is usual. In addition, for this study, patients are also     asked hold their breath after breathing in and again at a point between breathing in and out.     Each breath-hold is for around 15 seconds. The scans for each of the three different     breath-holds are examined for differences.      Some patients may also be asked to breathe through a tube called a pneumotachometer, or     spirometer, to determine their normal breathing pattern. This involves breathing through a     mouthpiece similar to a snorkel mouthpiece and takes about 2 minutes.   "
172365|NCT00089076|"     Biological therapies, such as MDX-010, work in different ways to stimulate the immune system     and stop cancer cells from growing. This phase I/II trial is studying the side effects and     best dose of MDX-010 and to see how well it works in treating patients with recurrent or     refractory B-cell non-Hodgkin's lymphoma.   "
172315|NCT00088374|"     This study will examine whether the drug 17AAG (17-allylamino 17-demethoxygeldanamycin) can     shrink kidney tumors in patients with Von Hippel-Lindau disease (VHL), a rare, inherited     syndrome in which patients develop tumors in certain parts of the body. 17AAG contributes to     the destruction of proteins in cells that may play in role in causing cancer and spurring     tumor growth. The study will also look at the effect of 17AAG on other tumors patients may     have that are caused by VHL, on the amount of blood vessels in the tumors, on the biologic     activity of the tumor, and on cells circulating in the bloodstream, as well as the safety of     the drug and its impact on the kidney tumor in patients whose tumor(s) is removed.      Patients 18 years of age and older with von Hippel-Lindau disease who have at least one     kidney tumor large enough to pose a risk of metastasis (spread of cancer to other parts of     the body) may be eligible for this study. Candidates are screened with a medical history and     physical examination, computed tomography (CT) scan, brain magnetic resonance imaging (MRI),     see below), and blood and urine tests. Additional tests, including a 24-hour urine     collection, ultrasound of the testicles in men, hearing test, eye exam, and MRI of the spine,     may be done if recent test results are not available.      Participants undergo the following tests and procedures:      MRI: This test uses a strong magnetic field and radio waves to show structural and chemical     changes in tissue. During the scan, the patient lies on a table in a narrow cylinder     containing a magnetic field, wearing earplugs to muffle loud noises that occur with     electrical switching of the magnetic fields. A catheter (plastic tube) is inserted into the     patient's arm to administer a contrast dye that enhances the images.      17AAG treatment: Patients receive 17AAG infusions into a vein once a week for 3 weeks out of     every 4, for 3 months. The infusions last up to 1 to 2 hours.      Repeat testing: After 3 months, patients have repeat MRI scans to measure changes in tumor     activity, blood flow, and number of blood vessels in the tumor since the pretreatment scans.     They may have additional tests, including a CT scan, eye exam, and other tests to evaluate     the effect of 17AAG on the tumors.   "
172316|NCT00088387|"     This study will examine the effect of the drugs lithium and divalproex (Depakote) on tau     proteins, a type of protein in the brain and spinal fluid that are altered in patients with     Alzheimer's disease. Both drugs are approved by the Food and Drug Administration to treat     mood disorders, and both have been shown in animal studies to decrease the amount of altered     tau protein. This study will determine whether lithium alone or in combination with     divalproex reduces the altered tau protein in the spinal fluid of patients with Alzheimer's     disease.      Patients with Alzheimer's disease who are between 40 and 90 years of age may be eligible for     this study. Candidates are screened with a medical history and physical examination,     neurologic and neuropsychological evaluation, blood and urine tests, electrocardiogram (EKG),     and, if needed, a magnetic resonance imaging (MRI) scan of the brain.      Participants undergo the following tests and procedures:        -  Drug treatment: Patients take study drugs for 6 weeks.        -  Weekly clinic visits: Patients come to the clinic once a week for a physical          examination, blood and urine tests, a review of drug side effects, and to receive the          next week's supply of medications.        -  Lumbar puncture (spinal tap): Patients have a lumbar puncture at study weeks 2, 4, and 6          to measure various brain chemicals and tau proteins in the cerebrospinal fluid (CSF),          which bathes the brain and spinal cord. For this test, a local anesthetic is given and a          needle is inserted in the space between the bones in the lower back where the CSF          circulates below the spinal cord. A small amount of fluid is collected through the          needle.        -  Follow-up visit: Two weeks after completing the study medication, patients return to the          clinic for a final evaluation, including a physical examination and blood and urine          tests.   "
172317|NCT00088400|"     Study Objectives:      Primary Objective:      To evaluate the efficacy of intratumoral/interstitial therapy with TransMID compared to best     standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma     multiforme.      Secondary Objectives:      To assess the safety of intratumoral/interstitial therapy with TransMID compared to best     standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma     multiforme.      To evaluate possible differences in efficacy and/or safety with TransMID associated with     differing degrees of transferrin receptor expression in tumor tissue and serum     anti-diphtheria toxin antibody titer levels.      Study Design:      Multicenter, open label, randomized study comparing TransMID with a chemotherapeutic regimen     considered to be best standard of care and consisting of either nitrosureas, platinum     compounds, temozolomide, procarbazine or PCV (procarbazine, lomustine (CCNU) & vincristine).     A planned interim analysis of the primary efficacy endpoint will be conducted after     approximately 50 percent of the required events have been observed.   "
172318|NCT00088413|"     Background:        -  Many cancers produce two proteins, carcinoembryonic antigen (CEA) and mucin-1 (MUC-1).        -  The PANVAC-V priming vaccine and PANVAC-F boosting vaccine contain human genes that          cause production of CEA and MUC-1, which can be used as a target for the immune system          to attack the cancer. The vaccines also contain genes that cause production of other          proteins that enhance immune activity.        -  Sargramostim is a protein that boosts the immune system.      Objectives:        -  To evaluate the safety and effectiveness of PANVAC-V and PANVAC-F in patients with          advanced cancer.        -  To document the immune response to the vaccines and any anti-tumor responses that may          occur.      Eligibility: Patients 18 years of age and older with advanced cancer whose tumors produce CEA     or MUC-1 protein      Design:        -  This trial has four arms: the first arm includes 10 patients with advanced colorectal          cancer; the second arm includes 10 to 15 patients with any advanced non-colorectal          cancer that produces either EA or MCU-1; the third arm includes about 12 patients with          advanced breast cancer; the fourth arm includes about 12 patients with advanced ovarian          cancer.        -  All patients receive PANVAC-V on study day 1, followed by PANVAC-F on days 15, 29 and          43. The vaccines are given by injection under the skin. Sargramostim is injected at the          vaccination site on the day of each vaccination and for the next 3 days following          vaccination.        -  Patients whose disease has not worsened after the last boosting vaccination may receive          up to 12 additional monthly boosting vaccinations. Following the 12 vaccinations,          patients may receive vaccine every 3 months. Patients whose scans show that their          disease has progressed, but who are otherwise clinically stable may revert back to          monthly injections.        -  Patients undergo apheresis to collect white blood cells (lymphocytes) on day 1 and day          71 of the study to measure the immune response to the treatment. Blood is collected          through a needle placed in one arm and directed through a cell separator machine where          the lymphocytes are extracted. The rest of the blood components are returned to the          patient through the same needle.        -  Patients are monitored with frequent blood tests and periodic imaging tests (scans) to          monitor for safety and the response to treatment.   "
172319|NCT00088426|"     This study will examine how holoprosencephaly (HPE) affects people, how they change over     time, and what genes may be involved in the cause of the disorder. HPE is a defect of brain     development in utero in which the forebrain fails to sufficiently divide into two     hemispheres, resulting in a single-lobed brain and skull and facial malformations. In most     cases, the defects are so severe that babies die before birth. There are three     classifications of HPE. In alobar HPE the brain does not divide at all; this form is usually     associated with severe facial deformities. In semilobar HPE the hemispheres divide somewhat,     causing an intermediate form of the disorder. In lobar HPE, the mildest form, separation of     hemispheres is nearly normal.      Patients with HPE and their direct blood relatives may participate in this study. Patients     are seen by a team of medical specialists at the NIH Clinical Center for the following     procedures:        -  Physical and neurological examination        -  Eye examination        -  Imaging studies, such as echocardiogram, abdominal ultrasound, brain MRI        -  Electroencephalogram (EEG)        -  Hearing evaluation        -  Blood and urine samples for genetic and endocrine studies, routine blood chemistries,          urinalysis, and urine electrolytes        -  Other consultations as needed        -  Possibly photographs, including front and side views of the face and other body parts          that may be involved in HPE, such as the eyes, teeth, hands, and feet      Parents will be asked questions about the child's prenatal, birth, newborn, and past medical     history, growth, behavior and development, and therapy and medication.      Because HPE is a genetic disorder and gene changes can be passed on in a family, parents will     also be asked to undergo the following procedures:        -  Completion of a medical and family history form        -  Physical and neurological examination        -  Blood and urine samples (for mothers only)        -  Specialty consultations as indicated        -  Possibly photographs, including front and side views of the face and other body parts          that may be involved in HPE, such as the eyes, teeth, hands, and feet        -  Psychosocial study. Some parents will be asked to participate in a telephone interview          or complete a questionnaire, or both, about their attitudes, beliefs, and concerns about          how they and their family cope with their child's condition. Some questionnaires may          include questions about aspects of their marriage and personal feelings and experiences.      Parents will meet with a doctor and a genetics nurse to discuss the results of the tests and     answer questions. Parents may be asked to bring their child back to the NIH after 2 years for     follow-up examination and possible additional or repeat testing.   "
172320|NCT00088452|"     The purpose of this study is to determine the best initial treatment for childhood absence     epilepsy.   "
172366|NCT00089089|"     This phase I trial is studying the side effects and best dose of decitabine in treating     patients with metastatic or unresectable refractory solid tumors or lymphomas. Drugs used in     chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing     so they stop growing or die   "
172323|NCT00088491|"     This is a randomized, double-blind study to determine how well intramuscular (IM) olanzapine     depot works compared to oral olanzapine; evaluate the safety and tolerability of IM     olanzapine depot compared to oral olanzapine; evaluate different doses of IM olanzapine     depot; and determine the blood levels of IM olanzapine depot in patients at different points     in time after an injection.   "
172324|NCT00088504|"     This trial is designed to test whether or not the addition of merimepodib (MMPD) to the     standard therapy of pegylated interferon and ribavirin will result in a positive treatment     response for people who have not previously responded to this therapy. Approximately 315     subjects will be enrolled in this research study at approximately 55 clinical sites in the     United States. There will be three study groups. Everyone in the study will receive Pegasys®     (pegylated interferon) and Copegus® (ribavirin) at the normally prescribed doses. Two of the     groups will also receive the study drug merimepodib (MMPD) twice a day, one group at each     dose level being tested. The third group will take a placebo instead of MMPD, with the     Pegasys® and Copegus®.      After the first 24 weeks of treatment, blood tests will be done to see if subjects are     responding to treatment. If they are responding, they will continue receiving study treatment     in the study for another 24 weeks. If they are not responding, they will stop study     treatment. Everyone who is responding will be monitored for 24 weeks after the last dose of     medication, to see how long the response lasts.      Evaluations will be performed during the study to look at the safety of the Pegasys®/Copegus®     and MMPD or placebo combination, and to see how the combination is working by measuring     Hepatitis C Virus in the blood.      At some of the clinical sites performing the study, some subjects may also participate in     additional testing to look at the metabolism of the drugs, or to look at the immune response     to Hepatitis C virus infection and treatment.   "
172325|NCT00088517|"     This study will investigate the use of [11C]NNC-112 in positron emission tomography (PET)     scanning. PET is a technique that uses radioactive isotopes called tracers to provide images     of the brain. Injected into the body, the isotopes lose their radioactive strength over     time, sending out rays that can be picked up and seen by special detectors connected to a     computer. The computer then makes a picture of the brain. This study will examine the     distribution in the body of a new tracer called [11C]NNC-112.      Healthy normal volunteers between 18 and 70 years of age may be eligible for this study.     Candidates are screened with a physical examination and blood and urine tests, including a     urine drug screen. Women up to age 55 also have a pregnancy test.      Participants have a PET scan using the [11C]NNC-112 tracer. For this procedure, a catheter     (small plastic tube) is placed into a vein in the subject's arm for injecting the tracer.     Then, the subject lies on the scanner bed. After a preliminary transmission scan, the     tracer is injected, and PET scans are taken from the head to the upper thigh over a period of     about 2 hours to show the distribution of radioactivity in the body. Blood pressure,     breathing rate, and heart rate are checked before and after injection of the tracer, and     blood and urine samples are collected after the PET scan.   "
172326|NCT00088530|"     BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows     reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural     similarities with mitoxantrone as well as general similarities with anthracyclines (such as     the tricyclic central quinoid chromophore).      The primary study objective is to compare the efficacy of BBR 2778 to a selection of single     agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a     selection of single agents, and to assess the pharmacokinetic parameters of BBR 2778 in a     subset of this patient population.   "
172327|NCT00088543|"     This study involves the use of a drug called Thymoglobulin, which is approved in the USA to     treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant     rejection. Thymoglobulin is not approved for the treatment or prophylaxis of graft versus     host disease in bone marrow transplantation. This study is to evaluate two (2) doses of     Thymoglobulin and its safety and effectiveness when used with a myeloablative conditioning     regimen prior to receiving a stem cell transplant (also called bone marrow transplantation)     from a matched, related donor.      A myeloablative regimen is typically composed of chemotherapy and radiation and destroys the     subject's existing bone marrow.      Subjects meeting all inclusion and exclusion criteria and who have a relative with matching     (genetically similar) stem cells who are also willing to donate them (i.e.     matched-related-donor) are eligible to participate in this study. Following myeloablative     therapy, the donor's cells are then transplanted (i.e. infused) into the subject's blood     stream.      One of the most common complications of this type of transplant is graft-versus-host disease     (GvHD). This is a condition where the transplanted donor cells attack the transplant     recipient's body. Treatments, such as cyclosporine, are used to minimize the risk of GvHD     following stem cell transplantation.      To enter this study, subjects must be having a matched-related donor stem cell transplant. If     a subject qualifies for entry into this study, he/she will be assigned to receive     Thymoglobulin at a dose of 4.5 mg/kg or 8.5 mg/kg. The treatment assignment is random and is     not chosen by the subject or their physician.      Subjects are admitted to the hospital for the transplant procedure and are treated with     Thymoglobulin over 3-5 days just prior to receiving the donor stem cells. The subject will     also receive standard GvHD prophylaxis with cyclosporine. Methotrexate, which is commonly     used by transplant centers to minimize the risk of GvHD, will not be used in this study.      Subjects will be monitored during treatment with Thymoglobulin and during the transplant     hospitalization. Additional subject monitoring occurs at month 1, 100 days and 6 months     following the transplant.      Approximately 60 study subjects from approximately 14 transplant centers in the United States     and Canada will be enrolled.   "
172328|NCT00088556|"     The purpose of this trial is to study the efficacy and safety of the triplet combination of     TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small     cell lung cancer.   "
172351|NCT00088881|"     This phase II trial is studying how well giving rituximab together with combination     chemotherapy and 90-Yttrium ibritumomab tiuxetan works in treating patients with stage I or     stage II lymphoma. Drugs used in chemotherapy, such as prednisone, cyclophosphamide,     doxorubicin, and vincristine, work in different ways to stop cancer cells from dividing so     they stop growing or die. Monoclonal antibodies such as rituximab and yttrium 90-Yttrium     ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive     cancer-killing substances to them without harming normal cells. Combining a monoclonal     antibody with combination chemotherapy and a radiolabeled monoclonal antibody may kill more     cancer cells.   "
172353|NCT00088907|"     Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells     from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by     blocking the enzymes necessary for their growth. Combining docetaxel with gefitinib may kill     more tumor cells. It is not yet known whether docetaxel is more effective with or without     gefitinib in treating head and neck cancer. This randomized phase III trial is studying     docetaxel and gefitinib to see how well they work compared to docetaxel alone in treating     patients with metastatic or locally recurrent head and neck cancer.   "
172446|NCT00097760|"     The purpose of this study is to determine if natalizumab in combination with Glatiramer     Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with     relapsing-remitting Multiple Sclerosis (MS).   "
172329|NCT00088569|"     This study will test a new electrical technique called direct current (DC) polarization that     is able to change brain activity in subtle ways for a short time. A recent study showed that,     depending on its direction, the current could make people perform a little better or perhaps     slightly worse on a test of the function of the brain's frontal lobe. This study will use     positron emission tomography (PET) scanning to examine how DC polarization affects brain     activity.      Healthy volunteers between 20 and 70 years of age who are right handed and who are not taking     any medications that affect the brain may be eligible for this study. Candidates are screened     with a brief medical history and neurological evaluation.      Participants have a PET scan on three different days at least 3 days apart. Each scanning     session takes 2-1/2 to 3 hours. For the scan, radioactive water is injected into the body     through a vein. Subjects lie on a bed that slides in and out of the doughnut-shaped scanner,     with their head held from the back by a padded holder and in front by a custom-molded plastic     mask with holes for the eyes, nose, and mouth. DC electrodes made of wet sponges are placed     on the right side of the head and over the left eye and are held in place with elastic     bandages.      Three kinds of DC polarization are tested. In two tests the current is the same, but in     opposite directions. The third is a sham (placebo) condition with no current delivered. Each     of the three scans is separated by at least 3 days. On each day, a series of scans is done in     a single session. Before each injection of tracer, the DC current is turned on. This may     cause a tingling or slight burning on the skin under the electrodes, which disappears when     the current is turned off. In each session, the subject receives 16 injections of tracer     about 8 minutes apart, with DC polarization turned on for 4 out of the 8 minutes.      During most of the 8-minute periods, subjects are shown a pattern of dots about every 2     seconds. Sometimes the subject just looks at the patterns, and sometimes subjects are asked     to push a button corresponding to the pattern they saw just before the current one. Sometimes     they will be asked to push a button corresponding to the pattern that came before that one     and so on, up to three patterns before the current one. The task lasts for about 2 minutes     each time, with time to relax in between.   "
172330|NCT00088582|"     5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.   "
172331|NCT00088595|"     Study evaluating SOM230 in patients with metastatic carcinoid tumors   "
172332|NCT00088608|"     The study treatment period is 15 days in length and includes patients with pituitary     Cushing's disease who are candidates for surgical intervention as well as and patients who     have recurrent Cushing's post operatively.   "
172333|NCT00088621|"     A 1-year outpatient study to test the safety and tolerability of a new medication in the     treatment of schizophrenia   "
172334|NCT00088634|"     A 6-week in-patient and out-patient study to test the effectiveness and safety of a new     medication in the treatment of schizophrenia   "
172335|NCT00088647|"     The primary objective of this clinical research study is to evaluate the safety,     tolerability, and maximum tolerated dose (MTD) of intravenous (IV) MST-997 formulated in     Intralipid 20% administered on a weekly schedule to subjects with advanced malignant solid     tumors.   "
172336|NCT00088660|"     The objectives of this multi-center, randomized, controlled trial are to evaluate the safety     and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating     factor (GM-CSF) versus best supportive care or palliative chemotherapy.   "
172337|NCT00088673|"     The purpose of this Phase III study is to evaluate the efficacy and safety of 3APS compared     to placebo (inactive substance pill) in patients with mild to moderate Alzheimer’s disease.   "
172338|NCT00088686|"     Capsaicin to Control Pain Following Third Molar Extraction      Summary: This study will test the effectiveness of the drug capsaicin in controlling pain     after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that     makes them hot, belongs to a class of drugs called vanilloids, which have been found to     temporarily inactivate pain-sensing nerves. If capsaicin alleviates pain in dental surgery,     it may have potential for use in many types of surgery and painful illnesses.      Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom     tooth) extraction may be eligible for this study. Participants undergo the following     procedures in three visits:      Visit 1      Patients have touch (sensory) testing inside the mouth using three methods: 1) applying a     temperature probe onto the gums and having the patient rate how warm it is; 2) applying a     gentle stroke across the gums with the bristles of a small paint brush and having the patient     say whether or not it feels painful; and 3) applying a light touch to the gums with a small     needle and having the patient rate the pain intensity following the touch. Following touch     testing, the patient's mouth is numbed with an anesthetic and a small piece of gum tissue     next to the lower wisdom tooth is removed (biopsied). Then, a small amount of either     capsaicin or placebo (saline, or salt water) is injected next to the wisdom tooth.      Visit 2      Following repeat the touch testing, patients are sedated with an injection of midazolam. They     then have another biopsy under local anesthesia on the same side of the mouth as the first     biopsy. Their mouth is again numbed with an anesthetic, and they are given either a     pain-relieving medicine called Toradol or a placebo injected into the arm. One lower wisdom     tooth is then extracted. After the extraction, pain ratings are recorded every 20 minutes for     up to 6 hours. During this time, patients are monitored for vital signs, numbness, pain, and     side effects. Patients who request pain-relief medication are given acetaminophen and     codeine. At the end of the study, they are discharged from the clinic and given acetaminophen     and codeine to take at home, as instructed. They are provided a pain diary to record pain     ratings and any adverse reactions that might occur until the last visit.      Visit 3      Patients return for a follow-up evaluation 48 hours after discharge from the clinic. At the     end of the evaluation, they are discharged home with flurbiprofen for pain relief. Remaining     wisdom teeth are removed off-study no sooner than 1 week following the first visit.   "
172339|NCT00088699|"     This study examines whether Ketamine can cause a rapid-next day antidepressant effect in     patients with Major Depression/Bipolar Disorder .      Purpose: This study will test whether a single dose of ketamine - a drug that blocks a brain     receptor called NMDA - can cause a rapid (next day) antidepressant effect in patients with     major depression. Several medications are effective for treating depression; however, they     take weeks or months to achieve their full effects. A more rapidly acting antidepressant     would have a significant impact on the treatment of depression. In a previous study, ketamine     produced a rapid antidepressant effect within hours, but the effect lasted less than 1 week.     Understanding how ketamine works may lead to a better understanding of the causes of     depression and the design of a longer lasting rapidly acting antidepressant.Patients between     18 and 65 years of age who are currently experiencing an episode of major depression of at     least 4 weeks duration and have not responded to two treatment trials may be eligible for     this study. Candidates are screened with a medical and psychiatric history, physical     examination, and blood and urine tests.Participants undergo the following tests and     procedures:Medication tapering: Patients who are taking medications for depression are     tapered off the drugs over a 1- to 2-week period. Ketamine/placebo trial: Patients are given     a single dose of either ketamine or placebo (an inactive substance), administered     intravenously (through a vein) over 40 minutes. After 7 days, patients are given another dose     of study drug in crossover fashion; that is, those who previously took ketamine are switched     to receive placebo, and those who took placebo are switched to ketamine. Oximetry     (measurement of blood oxygen), pulse, and blood pressure are measured continuously for 1 hour     before and 4 hours after each ketamine or placebo dose to monitor safety. Interviews and     rating scales: Patients complete a series of psychiatric rating scales to assess the effects     of the study drug on mood and thinking. The rating scales are repeated up to 18 times during     the study, with each time taking about 15 to 20 minutes. Physical examination and laboratory     tests: Patients have a physical examination, blood tests, weight measure, and     electrocardiogram (ECG) at the beginning and end of the study.   "
172352|NCT00088894|"     This randomized phase III trial is studying gemcitabine and bevacizumab to see how well they     work compared to gemcitabine alone in treating patients with locally advanced or metastatic     pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to     stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as     bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances     to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by     stopping blood flow to the tumor. Combining gemcitabine with bevacizumab may kill more tumor     cells. It is not yet known whether gemcitabine is more effective with or without bevacizumab     in treating pancreatic cancer.   "
174249|NCT00121849|"     This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult subjects with     a previous exposure to the Leishmania parasite (but without current or past history of     leishmaniasis).   "
172340|NCT00088712|"     This study will explore the development of visual perception and the brain activity that     underlies it. It will examine electrical activity in the brain while people are processing     characteristics of the visual environment, and how that processing might change with     development.      Infants who are within 2 weeks on either side of their 4-month birthday may be eligible for     this study. A parent of the child also participates.      Parents who join the study are asked basic questions about their family, such as its size and     ethnic make-up, their infant's birth date, complications of pregnancy or delivery, and any     health problems of the infant, such as congenital developmental disorders or visual     abnormalities.      Each family is seen at the clinic one time for a 45-minute visit. The infant is outfitted     with an elastic net containing many small sensors that make contact with the scalp. He or she     is then shown pictures on a computer screen. The sensors in the head net are connected to a     computer that records the infant's brain activity while the infant watches the pictures on     the screen. The head net is moistened with warm water before being applied, and is not     uncomfortable to wear. Towels are available throughout the session to dry any excess moisture     from the net.   "
172341|NCT00088738|"     This study is designed to observe the effects of a panic attack in patients with panic     disorders and to demonstrate the involvement of Substance P in panic disorder, and thereby,     further our understanding of its role in this illness. We will measure levels of Substance P     in the brain by obtaining pictures of the brain using PET and MRI....   "
172342|NCT00088751|"     Objectives. The proposed clinical study has two goals: First, to assess the efficacy of a     central nervous system stimulant and an atypical antipsychotic in treating the behavioral     symptoms of FTD and second, to further characterize the biological markers, including     genetic, imaging, and CSF proteins, of FTD in relation to our existing group of Alzheimer's     patients.      Rationale. Frontotemporal dementia (FTD) is increasingly recognized as an important     neuropsychiatric disorder. Symptoms of FTD include disinhibition, impulsivity, apathy,     affective lability, and language dysfunction. The clinical syndrome is associated with     frontal and/or anterior temporal atrophy on imaging and autopsy. Levels of the CSF proteins     tau and (Beta)-amyloid 1-42, shown to have diagnostic utility in patients with Alzheimer's     Disease (AD), have also been found to be abnormal in FTD. FTD is less associated with APOE     genotype than AD, however some familial cases of FTD are associated with specific mutations     in the gene encoding the tau protein. Currently, no treatments have been proven to be     effective for altering the course or clinical symptoms of FTD.      Design. Study subjects will include 50 male and female patients with mild-moderate     frontotemporal dementia recruited from participants in NINDS protocol 02-N-0001. In a     double-blinded crossover 11-week study without a placebo control, patients will be treated     with a stimulant (dextroamphetamine) and an atypical antipsychotic (quetiapine). The primary     outcome measures will be the Neuropsychiatric Inventory and the Clinical Global Impression of     Change. Cerebrospinal fluid, cognitive and genetic measures, brain MRIs, and side effects     scales will also be collected.   "
172343|NCT00088764|"     Self-management of rheumatoid arthritis (RA) symptoms using written emotional disclosure     (ED), coping skills training (CST), or a combination of both may benefit people with RA. The     purpose of this study is to determine the benefits of ED, CST, or CST and ED together in     adults with RA. This study will be conducted at Wayne State University in Detroit, Michigan     and Duke University Medical Center in Durham, North Carolina.   "
172344|NCT00088777|"     Fibromyalgia (FM) syndrome is a common chronic pain disorder that may benefit from nondrug     treatment. This study will compare the effectiveness of behavioral preparation, stress     management education, and fibromyalgia and coping education in relieving the symptoms of FM.     Each of these nondrug treatments will be combined with physical therapy and physical     education.      Specific aims: 1) Evaluate the efficacy of behavioral preparation programs on attrition,     compliance, and treatment outcomes of self-management rehabilitation for FM syndrome. 2)     Determine factors that mediate clinical efficacy. 3) Evaluate individual differences in     treatment responses to delineate who will benefit most from each type of the behavioral     preparation programs.   "
172345|NCT00088790|"     Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to     patients with advanced solid malignancies A review of the emerging clinical tolerability and     exposure data from this study in conjunction with preclinical and the available clinical     pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the     development of AZD5438 as a potential anti-cancer agent would be discontinued.   "
172346|NCT00088803|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that may occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This laboratory study is looking at DNA variations in the RASSF1A gene in young     patients with Wilms' tumor.   "
172347|NCT00088816|"     RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to     stop tumor cells from dividing so they stop growing or die. Combining more than one drug may     kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so     that it can be removed.      PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in     treating patients who are undergoing surgery for stage IV gastric cancer.   "
172348|NCT00088829|"     RATIONALE: Analyzing genes for changes before and after chemotherapy may help doctors predict     a patient's response to treatment and help plan the most effective treatment.      PURPOSE: This clinical trial is studying how well genetic testing works in predicting     response to paclitaxel in women who have unresected breast cancer.   "
172349|NCT00088855|"     This phase II trial studies the side effects and how well bortezomib and pegylated liposomal     doxorubicin hydrochloride work in treating patients multiple myeloma that are experiencing     symptoms and have not received prior treatment. Bortezomib and pegylated liposomal     doxorubicin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.   "
172350|NCT00088868|"     RATIONALE: Drugs used in chemotherapy, such as     17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop     cancer cells from dividing so they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating     patients with an advanced solid tumor or lymphoma.   "
174250|NCT00121862|"     This study will evaluate the safety and immunogenicity of the Leish-111f + MPL-SE vaccine in     adult subjects who have no evidence of previous exposure to the Leishmania parasite.   "
172354|NCT00088933|"     This randomized phase I trial studies the side effects, best way to give, and best dose of     docetaxel when given together with vaccine therapy and sargramostim in treating patients with     metastatic lung cancer or metastatic colorectal cancer. Vaccines may make the body build an     immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase     the number of immune cells found in bone marrow and peripheral blood. Drugs used in     chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so     they stop growing or die. Combining vaccine therapy and sargramostim with docetaxel may kill     more tumor cells.   "
172355|NCT00088946|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Green tea extract (Polyphenon® E) contains certain ingredients that may slow     the growth of tumor cells and prevent the recurrence of cancer. Giving erlotinib or green tea     extract after surgery may kill any remaining tumor cells and may prevent the recurrence of     bladder cancer.      PURPOSE: This randomized phase II trial is studying how well giving erlotinib together with     green tea extract works in preventing cancer recurrence in former smokers who have undergone     surgery for bladder cancer.   "
172356|NCT00088959|"     This phase I trial is studying the side effects and best dose of celecoxib when given     together with erlotinib in treating former smokers with stage IIIB, stage IV, recurrent, or     progressive non-small cell lung cancer. Celecoxib and erlotinib may stop the growth of tumor     cells by blocking the enzymes necessary for their growth.   "
172357|NCT00088972|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of celecoxib may be effective in preventing     breast cancer.      PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing     breast cancer in premenopausal women who are at risk for developing the disease.   "
172358|NCT00088985|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or     deliver tumor-killing substances to them without harming normal cells. Drugs used in     chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing     so they stop growing or die. Combining vaccine therapy with monoclonal antibody therapy and     chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with     trastuzumab and vinorelbine works in treating women with locally recurrent or metastatic     breast cancer.   "
172359|NCT00088998|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different     ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies     such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing     substances to them without harming normal cells. Bevacizumab may also stop the growth of     tumor cells by stopping blood flow to the tumor. Combining chemotherapy with monoclonal     antibody therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel and capecitabine together     with bevacizumab works in treating patients with metastatic breast cancer.   "
172360|NCT00089011|"     This phase II trial studies how well tacrolimus and mycophenolate mofetil works in preventing     graft-versus-host disease in patients who have undergone total-body irradiation (TBI) with or     without fludarabine phosphate followed by donor peripheral blood stem cell transplant for     hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and TBI     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.     It also stops the patient's immune system from rejecting the donor's stem cells. The donated     stem cells may replace the patient's immune system and help destroy any remaining cancer     cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also     make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate     mofetil after the transplant may stop this from happening.   "
172361|NCT00089024|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from     dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage     tumor cells. Giving combination chemotherapy with radiation therapy before surgery may shrink     the tumor so that it can be removed.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with radiation therapy works in treating patients who may undergo surgery for locally     advanced pancreatic cancer.   "
172362|NCT00089037|"     RATIONALE: Sirolimus, tacrolimus, and methotrexate may be effective in preventing acute     graft-versus-host disease in patients who are undergoing donor stem cell transplantation.      PURPOSE: This phase I/II trial is studying the side effects of sirolimus when given together     with tacrolimus and methotrexate and to see how well they work in preventing acute     graft-versus-host disease in patients who are undergoing donor stem cell transplantation for     hematologic cancer.   "
172363|NCT00089050|"     RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.     Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells     more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more     cancer cells.      PURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with     cyclosporine works in treating older patients with relapsed acute myeloid leukemia.   "
172364|NCT00089063|"     This randomized phase II trial is studying vaccine therapy and sargramostim to see how well     they work compared to vaccine therapy alone in treating patients who have undergone surgery     for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may     make the body build an immune response to kill tumor cells. Colony-stimulating factors such     as sargramostim increase the number of immune cells found in bone marrow or peripheral blood.     Combining vaccine therapy with sargramostim may make a stronger immune response.   "
172367|NCT00089102|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one     drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan     works in treating patients with locally advanced unresectable or metastatic kidney cancer.   "
173714|NCT00107770|"     The purpose of the study is to evaluate the safety of sodium phenylbutyrate (NaPB) treatment     in subjects with amyotrophic lateral sclerosis (ALS) and the ability to take this medication     without major side effects.   "
172368|NCT00089115|"     RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Vaccines made     from a person's cancer cells may make the body build an immune response to kill cancer cells.     Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone     marrow and peripheral blood. It is not yet known whether combining rituximab and GM-CSF with     vaccine therapy may cause a stronger immune response and kill more cancer cells.      PURPOSE: This randomized phase III trial is studying giving rituximab and GM-CSF together     with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating     patients with newly diagnosed, relapsed, or refractory B-cell non-Hodgkin's lymphoma.   "
172369|NCT00089128|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different     ways to stop tumor cells from dividing so they stop growing or die. Combining more than one     drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan     works in treating patients with locally advanced or metastatic bladder cancer.   "
172370|NCT00089141|"     RATIONALE: Mycophenolate mofetil added to immunosuppressive treatment regimens may be     effective in treating newly diagnosed chronic graft-versus-host disease caused by stem cell     transplantation. It is not yet known whether immunosuppressive treatment regimens are more     effective with or without mycophenolate mofetil in treating chronic graft-versus-host     disease.      PURPOSE: This randomized phase III trial is studying whether the addition of mycophenolate     mofetil improves the efficacy of immunosuppressive treatment regimens in patients with newly     diagnosed chronic graft-versus-host disease.   "
172371|NCT00089154|"     This phase II trial is studying how well apolizumab works in treating patients with chronic     lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies such as apolizumab     can locate cancer cells and either kill them or deliver cancer-killing substances to them     without harming normal cells.   "
172372|NCT00089167|"     RATIONALE: Drugs such as melphalan, thalidomide, and dexamethasone may be effective in     treating patients with primary systemic amyloidosis.      PURPOSE: This phase II trial is studying how well giving melphalan together with thalidomide     and dexamethasone works in treating patients with primary systemic amyloidosis.   "
172373|NCT00089180|"     This randomized phase II trial is studying how well T4N5 liposomal lotion works in preventing     the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant.     Chemoprevention therapy is the use of certain drugs to try to prevent the development of or     recurrence of cancer. T4N5 liposomal lotion may be effective preventing the recurrence of     nonmelanoma skin cancer in patients who have undergone a kidney transplant.   "
172374|NCT00089193|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.     Colony-stimulating factors such as sargramostim may increase the number of immune cells found     in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a     stronger immune response and kill more tumor cells.      PURPOSE: This randomized phase II trial is studying vaccine therapy and sargramostim to see     how well they work compared to vaccine therapy alone in treating patients with stage II B,     stage IIC, stage III, or stage IV melanoma.   "
172375|NCT00089206|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients     with stage III or stage IV melanoma that cannot be removed by surgery.   "
172376|NCT00089219|"     RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.      PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and     comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or     stage IV melanoma.   "
172377|NCT00089245|"     The purpose of this study is to find a safe dose of a new medicine called antibody 8H9.     Antibodies are made by the body to fight infections and in some cases, to fight tumors. The     antibody 8H9 is made by mice and can attack many kinds of tumors. 8H9 antibody can have a     dose of radiation attached to it called 131-I. 131I-8H9 has been given in the vein to     patients to find cancer cells. This is the first study using 131I-8H9 in the fluid in the     spine to kill cancer cells. 131-I is a beta emitting isotope used extensively for radiation     targeted therapies.   "
172378|NCT00089258|"     RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and     either kill them or deliver tumor-killing substances to them without harming normal cells.     Beta-glucan, isotretinoin, and sargramostim may increase the effectiveness of monoclonal     antibody 3F8 by making tumor cells more sensitive to the monoclonal antibody. Combining     different types of biological therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving beta-glucan, isotretinoin, and     sargramostim together with monoclonal antibody 3F8 works in treating patients with     neuroblastoma that has not responded to previous treatment.   "
172379|NCT00089271|"     This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients     with metastatic or unresectable solid tumors or lymphomas. Drugs used in chemotherapy, such     as 17-DMAG, work in different ways to stop cancer cells from dividing so they stop growing or     die   "
172380|NCT00089284|"     Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate     cancer cells and either kill them or deliver radioactive cancer-killing substances to them     without harming normal cells. Motexafin gadolinium may increase the effectiveness of yttrium     Y 90 ibritumomab tiuxetan by making the cancer cells more sensitive to the drug.      This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when     administered with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they     work in treating patients with stage II, stage III, or stage IV relapsed or refractory     non-Hodgkin's lymphoma.   "
172842|NCT00104104|"     The purpose of this trial is to study the safety of treating patients with multiple myeloma     and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks     for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.   "
172405|NCT00089635|"     The purpose of this study is to determine that ABX-EGF (panitumumab) will have clinically     meaningful anti-tumor activity in patients with metastatic colorectal cancer who have     developed progressive disease or relapsed while on or after prior fluoropyrimidine,     irinotecan and oxaliplatin chemotherapy.   "
172381|NCT00089297|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy     x-rays to damage tumor cells. Giving cetuximab with combination chemotherapy and radiation     therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that     needs to be removed. Giving cetuximab after surgery may kill any tumor cells that remain.      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination     chemotherapy and radiation therapy works in treating patients who are undergoing surgery for     stage III or stage IV head and neck cancer.   "
172382|NCT00089310|"     RATIONALE: Diagnostic procedures such as sentinel lymph node mapping may improve the ability     to detect cancer that has spread to the lymph nodes.      PURPOSE: This clinical trial is studying how well sentinel lymph node mapping works in     detecting cancer that has spread to the lymph nodes in patients who are undergoing surgery     for stage I non-small cell lung cancer.   "
172383|NCT00089323|"     RATIONALE: Diagnostic procedures that detect tumor cells in the bone marrow may help doctors     predict disease recurrence and plan more effective treatment.      PURPOSE: This clinical trial is studying how well diagnostic procedures work in detecting     tumor cells in the bone marrow of patients who have undergone surgery for stage I, stage II,     or stage IIIA breast cancer.   "
172384|NCT00089349|"     This phase II trial is studying how well giving alemtuzumab with or without methotrexate and     mercaptopurine works in treating young patients with relapsed acute lymphoblastic leukemia.     Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or     deliver cancer-killing substances to them without harming normal cells. Drugs used in     chemotherapy, such as methotrexate and mercaptopurine, work in different ways to stop cancer     cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with     chemotherapy may kill more cancer cells.   "
172385|NCT00089362|"     This phase I trial is studying the side effects and best dose of alvespimycin hydrochloride     in treating patients with metastatic or unresectable solid tumors. Drugs used in     chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop tumor cells     from dividing so they stop growing or die.   "
172386|NCT00089388|"     This randomized phase II trial is studying how well cilengitide works in treating patients     with acute myeloid leukemia. Cilengitide may stop the growth of cancer cells by blocking the     enzymes necessary for their growth   "
172387|NCT00089401|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop     tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different     ways may kill more tumor cells.      PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan     works in treating patients with unresectable colorectal cancer that has metastasized to the     liver.   "
172388|NCT00089414|"     This study will determine whether uninterrupted treatment with birth control pills over     several menstrual cycles prevents severe premenstrual syndrome (PMDD).      Previous studies have shown that the hormones estrogen and progesterone regulate mood in     women with MRMD. This study will use various treatment regimens with birth control pills and     placebo (sugar pill) to clarify the relationships among estrogen and progesterone, the     menstrual cycle, and mood.      Healthy women between 18 and 45 years of age who menstruate may be eligible for this 15-week     study. Candidates are screened with a physical examination, blood and urine tests, an     electrocardiogram, and 3 months of symptoms ratings to confirm MRMD.      Participants are randomly assigned to one of three treatment groups. Group 1 takes a birth     control pill every day and on three occasions takes a placebo capsule. Group 2 takes a birth     control pill most but not all days and on three occasions takes a placebo capsule. Group 3     takes a birth control pill every day and on three occasions takes another medication called     CDB-2914 that causes menstrual bleeding to occur.      Participants come to the NIH clinic every other week for blood tests and measurement of vital     signs (blood pressure, pulse, and temperature) and to complete symptoms ratings scales.     Subjects who develop breakthrough bleeding (menstruation earlier than expected) will have a     transvaginal ultrasound. For this procedure, a probe is inserted into the vagina for about 10     minutes. The probe gives off and receives sound waves that can be used to form a picture of     the endometrium (lining of the uterus).   "
172389|NCT00089427|"     This Phase 1 study in patients with newly diagnosed malignant glioma is designed to determine     the highest dose of IL13-PE38QQR that can be safely administered by Convection Enhanced     Delivery (CED) to the area around the tumor site after the tumor is surgically removed     (resection). In addition, the patient will receive radiation therapy and may or may not be     treated with oral temozolomide.   "
172390|NCT00089440|"     The purpose of this study is to assess the interactions between intravenous methamphetamine     and aripiprazole.   "
172391|NCT00089453|"     The purpose of this study is to induce anti-myeloma responses in patients with high risk or     relapsed myeloma using combination chemo- and immunotherapy comprising sequentially: 1)     lymphoid and myeloid suppressive conditioning, 2) adoptive transfer of purified KIR-ligand     mismatched Natural Killer cells from a haplo-identical donor, and 3) autografting two weeks     after infusion of NK cells to ensure autologous reconstitution. Other objectives include     establishing the response rate, disease free survival, progression free survival and toxicity     of regimen. Secondary objectives are to monitor the persistence of haplo-identical purified     KIR-ligand mismatched Natural Killer cells by molecular methods, select haplo-identical     purified KIR-ligand mismatched donors and predict prior to therapy which donor will induce a     response, monitor Natural Killer cell reconstitution prior to and after autografting, and     establish Natural Killer cell clones after autografting and determine origin and specificity.   "
172392|NCT00089466|"     New treatment options are critical for treatment-experienced HIV infected patients with drug     resistance. HIV entry inhibitors have been shown effective in patients with resistance to     other anti-HIV drugs. This study will test the safety and anti-HIV activity of eight     different doses of the HIV entry inhibitor AMD11070 (also known as AMD070) in HIV infected     patients.   "
172843|NCT00104117|"     The purpose of this study is to assess the safety and tolerability of XL999 in adults with     advanced solid tumors.   "
172393|NCT00089479|"     This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere     alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer.     Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either     1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle     or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study     treatment is until disease progression, and the target sample size is 500+ individuals.   "
172394|NCT00089492|"     This study will assess the safety and efficacy of once-daily administration of Fuzeon     compared with twice-daily administration in HIV-1 infected patients who have received prior     treatment. Patients will also receive an optimized treatment consisting of antiretroviral     (ARV) therapy as determined by the treating physician. The anticipated time on study     treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
172395|NCT00089505|"     Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly included in anti-HIV     drug regimens. However, HIV infected women who have previously taken the single dose NNRTI     nevirapine (SD NVP) for the prevention of mother-to-child transmission (MTCT) of HIV may not     respond as well to NNRTIs as women who have never taken NVP. Another class of anti-HIV drugs,     protease inhibitors (PIs), may be more effective for women who have previously taken NNRTIs.     This study will compare the effectiveness of NNRTI- and PI-based regimens in women who have     taken NVP for prevention of MTCT of HIV. This study will also compare regimens including an     NNRTI with regimens including a PI in women who have never taken NVP.   "
172396|NCT00089518|"     The angiotensin receptor blocker (ARB) valsartan is a drug commonly used to treat high blood     pressure. Valsartan may also help slow down the progression of kidney disease in HIV infected     people. The purpose of this study is to compare valsartan and antiretroviral therapy (ART) to     ART alone in slowing kidney disease progression in people with HIV.   "
172397|NCT00089531|"     This study will evaluate whether an experimental vaccine intended to prevent HIV infection is     safe and whether it causes any side effects. It will also examine whether the vaccine, called     VRC-HIVDNA016-00-VP, causes an immune response, and will monitor participants for the social     impact of being in an HIV vaccine study. VRC-HIVDNA016-00-VP contains synthetic DNA that     codes for parts of four HIV proteins. It also contains a promoter piece of DNA that is     needed to start protein production. The promoter DNA is also synthetic and is like the     promoter in another virus called cytomegalovirus (CMV). The vaccine contains no live HIV     virus or CMV and cannot cause either of these illnesses.      Healthy volunteers between 18 and 44 years old who are HIV-negative may be eligible for this     32-week study. Candidates are screened with a medical history, physical examination, and     blood and urine tests.      Participants receive three injections of the experimental vaccine approximately 28 days     apart. The injections are given with a system called the Biojector 2000 that delivers the     vaccine through the skin into the muscle without the use of a needle. Subjects are observed     for side effects for at least 30 minutes after each vaccination and are required to telephone     the clinic staff 1 to 2 days after the injection to report how they are doing. In addition,     they are given a diary card to take home, on which they record their temperature and any     symptoms daily for five days.      Participants return to the clinic two weeks after each injection. They return the completed     diary card and are checked for any health changes or problems since the last visit. They are     asked how they are feeling and what medications, if any, they have taken. Blood and urine     samples are collected. Some subjects may be asked to have laboratory tests between regular     visits if needed to evaluate a change in health. Participants are also asked about any social     effects they may have experienced as a result of their participation in the study.   "
172398|NCT00089544|"     Thalidomide may stop the growth of soft tissue sarcoma by stopping blood flow to the tumor.     Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy,     such as doxorubicin, ifosfamide, and dacarbazine, work in different ways to stop tumor cells     from dividing so they stop growing or die. Giving thalidomide together with radiation therapy     and/or chemotherapy before surgery may shrink the tumor so that it can be removed. This phase     II trial is studying how well giving preoperative (before surgery) thalidomide together with     radiation therapy works in treating patients with low-grade primary soft tissue sarcoma, and     how well giving thalidomide together with radiation therapy, doxorubicin, ifosfamide, and     dacarbazine works in treating patients with high-grade or intermediate-grade primary soft     tissue sarcoma of the arm, leg, chest wall, or abdominal wall.   "
172399|NCT00089557|"     This study is an open-label, multicenter, extension study for subjects who completed     NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks     (up to +7days) before entry into Study C114   "
172400|NCT00089570|"     The purpose of this study is to determine whether terlipressin is safe and effective in the     treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo.   "
172401|NCT00089583|"     This is a 48-week study to collect information on the safety and activity of an     investigational medicine in patients, ages 2 to 18 years old, with HIV infection .   "
172402|NCT00089596|"     This study hopes to show that specially treated umbilical cord cells, called stem cells, can     be safely given to a person after they receive chemoradiation therapy or chemotherapy for     their illness. During chemoradiation therapy or chemotherapy, a person loses all of the cells     that are needed to make the different types of cells in their blood, including their immune     system cells. These cells must be replaced in order for the blood and immune systems to work     properly. Some people receive bone marrow transplants or other types of stem cell transplants     to get the cells they need. CB001 is being developed as an option for people who need bone     marrow transplants or other types of transplants to replace those cells. It is also being     developed for people who do not have the option of other types of transplants.   "
172403|NCT00089609|"     This is a Phase II study of docetaxel, bevacizumab, prednisone and thalidomide in patients     with androgen independent metastatic prostate cancer who are previously untreated with     chemotherapy. The primary objective of this study is to determine if the combination of     docetaxel, thalidomide and bevacizumab is able to be associated with a sufficiently high     proportion of patients with a prostate-specific antigen (PSA) response to be worthy of     further investigation in metastatic prostate cancer. We will also be looking at multiple     secondary endpoints. These will include possible pharmacokinetic interactions among the study     agents, potential correlation between patient genotype and efficacy of treatment. We will     also be looking for circulating tumor cells in blood before and after treatment. Additionally     we will be monitoring the tolerability of the regimen and survival duration as endpoints as     well. We hope to use this trial to build on the promising results seen in our     thalidomide/docetaxel protocol where there was a significant PSA decline and a trend toward     survival benefit.   "
172404|NCT00089622|"     This study will evaluate the effectiveness of a skin patch formulation of the dopamine     agonist Lisuride in controlling parkinsonian symptoms and dyskinesias (involuntary movements)     caused by levodopa. Lisuride is currently available in tablet form; this study will test     whether a patch formulation that provides continuous stimulation of the dopamine receptors     will better control disease symptoms.      Patients between 40 and 80 years old with Parkinson's disease and dyskinesias may be eligible     for this 4-month study. Participants undergo the following procedures:      Screening and baseline evaluation: Participants are evaluated with a medical history,     physical examination, neurologic evaluation, blood tests, urinalysis, and electrocardiogram.     A chest X-ray and MRI or CT scan of the brain are done, if needed. If possible, patients stop     taking all antiparkinsonian medications except levodopa (Sinemet) for 1 month (2 months for     Selegiline) before the study begins and throughout its duration.      Dose-finding phase: Patients are admitted to the NIH Clinical Center for 2 to 3 days for a     levodopa dose-finding procedure. For this test, patients stop taking Sinemet and instead     have levodopa infused through a vein. During the infusions, the drug dose is increased slowly     until parkinsonian symptoms improve or unacceptable side effects occur or the maximum study     dose is reached. Symptoms are monitored frequently. (Patients who have had dosing infusions     in the last 3 months do not have to undergo this phase of the study.)      Active study phase: Patients are randomly assigned to one of two treatment groups. One group     receives a placebo (a patch with no active drug) and a patch that contains Lisuride; the     other group receives placebo throughout the entire study. Patients are instructed on how to     apply the patches. During the first 2 weeks of this study phase, the number of patches     containing active drug is gradually increased until the individual's optimum dose is reached.     Patches are changed about every 2 days. During this time, intake of other antiparkinsonian     medications is tapered down and patients are evaluated frequently. For the next 3 months,     patients wear the patches continuously at the optimum dose. The patches are changed every 2     days or once a week, depending on the individual patient's need. Two levodopa infusion     studies are done in the active study phase as they were in the dose-finding phase - at the     beginning of the dose escalation phase and again at the end of the dose maintenance phase. In     addition, patients are tested for their ability to perform different motor tasks.      Sleep studies: Because oral Lisuride can cause excessive sleepiness, some patients are asked     to participate in a sleep study to evaluate sleep patterns during the night and daytime     sleepiness. The subject's brain, muscles, and breathing are continuously monitored during     sleep. Also, an electroencephalogram (EEG) is done to record brain waves while the subject     lies quietly, breathes deeply, watches flashes of light, sleeps, or performs a task.      Safety checks: Patients are monitored closely for safety with a history of side effects,     blood tests, and ECG each time a new supply of study drug is dispensed.      Follow-up: 2 weeks after completing the active phase of the study, patients are contacted by     phone for a follow-up evaluation.   "
172844|NCT00104130|"     The purpose of this trial is to study KOS-862 in men with metastatic prostate cancer who have     failed a docetaxel-containing regimen.   "
172410|NCT00089700|"     This is a 48-week study to compare TNX-355 plus OBT to placebo plus OBT in HIV subjects. You     must have a stable viral load of at least 10,000 copies/ml, been treated with highly active     antiretroviral therapy (HAART) for at least 6 months, be triple class experienced, and     presently failing or have failed a HAART regimen. Subjects will receive infusions every week     for 8 weeks, then every two weeks.   "
172411|NCT00089713|"     This study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week     double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide     treatment phase. The combined total duration of patient participation is approximately 17-20     weeks. Four double-blind treatment groups approximately equal in size (98) will comprise the     study population: placebo or various alagebrium dose groups (10, 50, or 150 mg/day).   "
172412|NCT00089726|"     The main purpose of this research study is to determine if a vaccine made from a patient's     lung cancer tumor cells will be effective in making the cancer shrink or disappear. The     vaccine will be given by itself to some patients, while other patients will get the vaccine     with cyclophosphamide (a type of chemotherapy). Studies in animals and other cancer vaccine     trials suggest that cyclophosphamide may make tumor vaccines more potent. This study will try     to determine if vaccine given with or without this chemotherapy is effective in destroying     lung cancer cells. Additionally, the study will collect information on vaccine safety, both     with and without chemotherapy, and whether the vaccine improves lung cancer-related symptoms     (e.g., shortness of breath).      Tumors from surgical resection will be processed and made into a vaccine. Prior to treatment,     patients will be randomized equally to one of two treatment groups, Cohort A and Cohort B.     Patients in Cohort A will be treated with CG8123 vaccine only and patients in Cohort B will     be treated with CG8123 vaccine plus a single dose of cyclophosphamide administered one day     prior to the first, third, and fifth vaccine treatments. Patients will receive intradermal     (beneath the skin) vaccine injections every two weeks for up to eight weeks, for a total of     up to five vaccine treatments. The duration of this study, including active follow up, is     approximately two years. After this, patients will be followed-up yearly for a total of 15     years.   "
172413|NCT00089739|"     This study will try to identify markers of immune activity in uveitis patients that correlate     with the state of disease activity. Uveitis is a group of inflammatory eye diseases that can     cause vision loss. The study will examine whether certain substances in the blood can predict     a reactivation of disease before it occurs, and how therapy may influence the activity of     these substances. Previous studies have found some possible markers called GITR     (glucocorticoid induced TNF related family receptor), SOCS (suppressors of cytokine     secretion), and interleukin-15. Markers such as these may help guide physicians in safely     tapering medicines in uveitis patients.      Patients 18 years of age and older with sight-threatening uveitis may be eligible for this     study. Participants are slowly tapered off their medicines when their disease is stable and     there is no evidence of significant inflammation. If the disease remains inactive during     tapering, all drug therapy is eventually stopped. Patients have eye examinations about every     1 to 3 months when the disease is quiet and every 2 to 4 weeks during flare-ups. Blood     samples are drawn 2 to 3 times a year. In addition, patients may have the following     procedures if needed:        -  Eye photography: Eye drops are given to enlarge the pupils for a thorough eye          examination, and a special camera is used to take photographs.        -  Fluorescein angiography: This test checks for abnormalities of eye blood vessels. A          yellow dye is injected into an arm vein and travels to the blood vessels in the eyes.          Pictures of the retina are taken with a special camera that flashes a blue light into          the eye. The pictures show if any dye has leaked from the vessels into the retina,          indicating possible abnormalities.   "
172414|NCT00089752|"     The purpose of this study is to determine whether functional status improves in individuals     with milder obstructive sleep apnea (OSA) following continuous positive airway pressure     (CPAP) treatment.   "
172415|NCT00089765|"     This study will examine whether he drug ranibizumab can slow or stop the growth of angiomas     (blood vessel tumors) in patients with Von Hippel-Lindau syndrome (VHL). Angiomas commonly     develop in the back of the eye on the retina and the optic nerve in patients with VHL.     Although these tumors are not cancerous, they may cause significant vision loss. Current     treatments, including laser therapy, cryotherapy, and vitrectomy, may not be successful or     possible for all patients. Ranibizumab decreases production of VEGF, a growth factor that is     important for the formation of new blood vessels and that is elevated in patients with VHL.     Preliminary findings from other studies suggest that ranibizumab can reduce retinal     thickening caused by vessel and tumor growth and improve vision.      Patients 18 years of age and older with retinal angiomas due to VHL in one or both eyes and     central vision loss of 20/40 or worse may be eligible for this study. Participants undergo     the following tests and procedures:        -  Medical history, physical examination, electrocardiogram (EKG) and blood tests.        -  Eye examination, including eye pressure measurement and dilation of the pupils to          examine the retina.        -  Fluorescein angiography to evaluate the eye's blood vessels. For this test, a yellow dye          is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of          the retina are taken using a camera that flashes a blue light into the eye. The pictures          show if any dye has leaked from the vessels into the retina, indicating possible blood          vessel abnormality.        -  Optical coherence tomography to measure retinal thickness. The eyes are examined through          a machine that produces cross-sectional pictures of the retina. These measures are          repeated during the study to determine changes, if any, in retinal thickening.        -  Stereoscopic color fundus photography to examine the back of the eye. The pupils are          dilated with eye drops to examine and photograph the back of the eye.        -  Electroretinogram (ERG) to measure electrical responses generated from within the          retina. For this test, the patient sits in a dark room for 30 minutes with his or her          eyes patched. Then, a small silver disk electrode is taped to the forehead, the eye          patches are removed, the surface of the eye is numbed with eye drops, and contact lenses          are placed on the eyes. The patient looks inside an open white globe that emits a series          of light flashes for about 20 minutes. The contact lenses sense small electrical signals          generated by the retina when the light flashes.        -  Ranibizumab injections to treat ocular angiomas. Ranibizumab is injected through a          needle into the eye's vitreous (gel-like substance that fills the inside of the eye).          Seven injections are given over a 28-week period. Before each injection, the surface of          the eye is numbed with anesthetic eye drops. This is followed by injection of another          anesthetic into the lower portion of the eye in the clear tissue surrounding the white          of the eye. After a few minutes, the ranibizumab is injected into the vitreous. Patients          receive ranibizumab injections at the first visit (during enrollment) and again at 4, 8,          12, 16, 20 and 24 weeks after the first injection. At the 28-week visit, the doctor will          determine if further treatment is needed. Patients can continue to have injections every          4 weeks until 1 year of follow-up (54 weeks).      At each injection visit, participants repeat most of the tests described above to evaluate     the response to treatment and return a week later for another eye examination.   "
172416|NCT00089778|"     This study will evaluate the safety and side effects of two experimental vaccines in patients     with kidney cancer and determine whether the vaccines turn on an immune response to the     cancer. Each vaccine contains one of two peptides (pieces of proteins) from the fibroblast     growth factor 5 (FGF-5) antigen, a protein produced by some cancer cells, and an oil-based     liquid called Incomplete Freud's Adjuvant (Montanide ISA-51) that enhances the immune     response to the vaccine.      Patients 16 years of age and older who have kidney cancer that has spread beyond the kidney     or whose primary kidney tumor has been removed within 6 months before entering the study and     are at high risk for disease recurrence may be eligible for this study. Patients must have     tissue type human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2) or human     leukocyte antigen serotype within HLA-A A serotype group (HLA-A3) (determined by a blood test     for human leukocyte antigen (HLA) typing) and their tumors must produce the FGF-5 peptide.     Candidates are screened with a physical examination, blood and urine tests, electrocardiogram     (EKG), tumor biopsy (removal of a small sample of tumor for examination) in patients whose     tumor is easily accessible, and scans (computed tomography (CT), bone scans) and x-rays if     current scans are not available.      Participants are divided into two groups according to their HLA type (HLA-A2 or HLA-A3) to     receive the vaccine appropriate for their HLA type. They are then further divided into three     groups: 1) Group 1 includes patients who do not need or are ineligible for treatment with     interleukin-2 (IL-2), a protein made by certain infection-fighting white cells that helps     fight tumors) and patients who have previously had IL-2 therapy; 2) Group 2 includes patients     who require immediate treatment with IL-2; and 3) Group 3 includes patients whose cancer has     been surgically removed but who are at risk for recurrence.      Patients in Groups 1 and 3 receive two peptide injections four times a week every 3 weeks for     up to a year, or until their tumor grows (or returns in patients in Group 3) or the side     effects are too severe to continue. Tumors are evaluated with a physical examination and     scans or x-rays every 12 weeks and blood tests are done every 3 weeks. Patients in Group 2     receive two peptide injections every day for 4 days, along with doses of IL-2 starting the     day after the first peptide injection. The vaccines are given as injections under the skin of     the thigh. IL-2 is infused through a vein over 15 minutes every 8 hours for up to 12 doses,     depending on tolerance. The vaccine and IL-2 are repeated every 10 to 14 days, with tumor     evaluations every 2 months. Patients stay in the hospital about 1 week during each treatment     cycle to receive the IL-2.      All patients undergo leukapheresis, a procedure for collecting large numbers of white blood     cells. Blood is collected through a needle in an arm vein and flows through a cell separator     machine, where the white cells are extracted. The rest of the blood is returned to the     patient through the same needle or a needle in the other arm. The white cells are examined to     evaluate how the vaccines change the action of immune cells. Some patients may undergo an     additional biopsy of normal skin and tumor or lymph node to look at the effects of the     vaccine on the immune cells in the tumor.      Patients in Group 1 whose cancer grows and patients in Group C whose cancer returns may be     offered IL-2 treatments as given to Group 2 patients, along with the peptide vaccine. If the     disease responds to IL-2, the treatment may be repeated after 2 months.   "
172417|NCT00089791|"     This study will evaluate the effectiveness and safety of denosumab in treating women with     Postmenopausal Osteoporosis.   "
172418|NCT00089804|"     The primary purpose of this study is to determine whether abetimus sodium is more effective     than placebo in delaying time to renal flare in SLE patients with a history of renal disease.   "
172419|NCT00089830|"     Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that     causes a progressive loss of central vision. AMD is the leading cause of legal blindness     among adults age 50 or older in the Western world. AMD presents in two different types -     dry and the more severe wet form. Wet AMD is caused by the growth of abnormal blood     vessels in the macula. Squalamine lactate is an investigational drug that may prevent the     growth of these abnormal blood vessels. This study will test the safety and efficacy of     Squalamine in the treatment of AMD.   "
172420|NCT00089843|"     Women with Anorexia Nervosa have been found to have low bone density. The study will     determine whether administration of low doses of a natural hormone, testosterone and/or     risedronate, a medication to help prevent bone breakdown will improve or prevent bone loss in     this condition.   "
172876|NCT00104585|"     The purpose of this study is to investigate genetic and environmental risk factors that     increase susceptibility to the development of early-onset Parkinson's disease (developed at     or before age 50).   "
172421|NCT00089856|"     The purpose of this study is to compare the duration of survival between GVAX® immunotherapy     for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer     respond to hormone therapy, who have documented metastases, and who have not been treated     with chemotherapy in the past.   "
172422|NCT00089869|"     Study of a medication for the treatment of Schizophrenia in patients who are already taking     Abilify, Risperdal, Seroquel, Zyprexa   "
172423|NCT00089882|"     The REVEAL II study provides healthy adult children and siblings of Alzheimer's disease     patients with genetic testing and information about their own chances of developing the     disease. The study will compare a condensed education and counseling program to the current     more extensive program.   "
172424|NCT00089895|"     The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients     with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death,     heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed     provisional use of eptifibatide).   "
172427|NCT00089947|"     This study involves the use of a drug called Thymoglobulin, which is approved in the US to     treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant     rejection.      This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent     renal transplant rejection and will provide a basis for future evaluations of Thymoglobulin     as an immunosuppressive agent to help prevent renal transplant rejection.      Subjects meeting all inclusion and exclusion criteria are eligible to participate in this     study. In addition to standard treatment, study participants will receive either     Thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for     at least the first 90 days after transplant. The treatment assignment is random and is not     chosen by the subject or their physician.      Subjects will be monitored during treatment with Thymoglobulin and during the transplant     hospitalization. Additional subject monitoring occurs at Months 1, 3, 6 and 12 following the     transplant.      Approximately 150 study subjects from 15-20 transplant centers in the United States will be     enrolled.   "
172428|NCT00089960|"     This study will determine the safety and effectiveness of AMG 706 in patients with advanced     GIST.   "
172429|NCT00089973|"     The purpose of this research study is to find how breast cancer responds to the     investigational drug, Ispinesib. An investigational drug is a drug that has not been approved     by the Food and Drug Administration (FDA) and is available for research use only. In     particular, this study will try is to find the answers to the following research questions:        1. Does breast cancer respond to Ispinesib?        2. What are the side effects of Ispinesib?        3. How much Ispinesib is in the blood at specific times after it is taken?   "
172430|NCT00089986|"     The primary objective is to estimate the size of the GR270773 treatment effect on 28-day     all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected     or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day     continuous intravenous infusion.   "
172431|NCT00089999|"     This phase II study will evaluate and compare the efficacy and tolerability of two dose     schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with     advanced or metastatic breast cancer.   "
172432|NCT00090012|"     The purposes of this study are to determine:        -  The effectiveness of olanzapine as compared to quetiapine in treating and preventing the          recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in          patients who are obese or overweight.        -  The safety of olanzapine as compared to quetiapine.   "
172433|NCT00090025|"     The main purpose of this study is to determine if XL119 is more effective than the     combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of     subjects with advanced biliary tumors.   "
172434|NCT00090038|"     The purpose of this study is to provide treatment for patients who have relapsed     Non-Hodgkin's lymphoma (NHL) or refractory NHL, and to test the immunity of study subjects     after receiving four treatments with rituximab.   "
172435|NCT00090051|"     The purpose of this study is to provide treatment for patients who have chronic lymphocytic     leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide     (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of     leukemia symptoms.   "
172436|NCT00090064|"     This study is being conducted to find out if methylenedioxymethamphetamine (MDMA)-assisted     psychotherapy is safe and can help people with posttraumatic stress disorder (PTSD) arising     from being a victim of a crime.   "
172437|NCT00090077|"     To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse     transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients   "
172438|NCT00090090|"     To determine the safety and efficacy of elsamitrucin in patients with relapsed or refractory     non-Hodgkin's lymphoma (NHL). To determine if elsamitrucin is efficacious in a particular     pathologic NHL subtype(s).   "
172439|NCT00090103|"     This study will investigate the efficacy and safety of treatment with dutasteride and     tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement     of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic     Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits).     Transrectal ultrasound (TRUS) is done annually.   "
172440|NCT00090116|"     Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to     chronic release of a brain chemical called glutamate. Glutamate helps transmit messages     between nerve cells through interaction with a certain type of receptor     (N-methyl-D-aspartate, NMDA) on the cell. Neramexane is a new drug that blocks the effects of     excessive glutamate at the receptor (NMDA receptor antagonist).   "
172877|NCT00104598|"     This is a randomized study of message framing in individuals beginning a smoking cessation     program utilizing bupropion SR and brief counseling, videos, and pamphlets.   "
172441|NCT00090129|"     The is a double-blind, placebo-controlled, randomized, and multicenter study consisting of a     first treatment (FT) period followed by either an observation (OB) period and a re-treatment     (RT) period or an open-label (OL) treatment period, depending on FT period response, and a     4-week safety follow-up (FU) period. The purpose of this study is to evaluate the safety and     efficacy of onercept, to be administered as 150 milligram (mg) three times a week, compared     to matching placebo, for the induction of remission in subjects with moderate to severe     plaque psoriasis.   "
172442|NCT00090142|"     The purpose of this study is to determine the effect of an approved medication being studied     in support of a new approach in the prevention of exercise-induced asthma (a worsening of     asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have     a history of worsening asthma after exercise.   "
172443|NCT00090155|"     The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug     for a new indication in the prevention of postoperative nausea and vomiting in patients     receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.   "
172444|NCT00097734|"     The purpose of this study is to compare the efficacy (by assessing the clinical success of     treatment) of intravenous antibiotic therapy with ertapenem in patients with acute attacks of     sigmoid diverticulitis for 4 vs. 7 days.   "
172445|NCT00097747|"     The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum     pharmacologically active dose of peginesatide in Healthy Volunteers.   "
172447|NCT00097773|"     Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung     function. Antibiotic medications have been proven effective at reducing Pseudomonas     aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF.     The purpose of this study is to compare the effectiveness of treatment based on quarterly     culture results versus consistent quarterly antibiotic treatment at reducing PA infection in     children with CF.   "
172448|NCT00097786|"     This study is a test of the safety and effectiveness of two drugs, one for diabetes and one     for hypertension, in keeping patients with high lab values of glucose from progressing to     frank diabetes and developing cardiovascular complications. People in this study cannot have     frank diabetes but are considered borderline based on blood tests. People in the study take     none, one or both of the drugs and do not know which one(s) they are taking.   "
172449|NCT00097799|"     This study was designed to provide early access to and evaluate the safety of TPV/r in     PI-experienced patients with HIV-1 infection.   "
172450|NCT00097812|"     The purpose of this study is to assess bone mineral density in patients switching from an     oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.   "
172451|NCT00097825|"     The goal of this study is to determine the effectiveness and safety of an annual intravenous     treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will     receive calcium and vitamin D supplements.   "
172452|NCT00097838|"     The purpose of this study is to evaluate the safety of and immune response to an alphavirus     replicon, HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults in the United States,     South Africa, and Botswana.   "
172453|NCT00097851|"     PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new     blood vessels into tumours. Docetaxel is a standard second-line treatment offered to patients     with non-small-cell lung cancer who haven't responded to first-line therapies (platinum-based     drugs or radiotherapy). Of this group of patients, only 20% remain progression-free 6 months     after starting docetaxel treatment. The PR88202 study has been designed to compare two     different cancer treatments (docetaxel only, and docetaxel plus PI-88) and to work out which     is more effective against the cancer. It is hoped that the combination of PI-88 with     docetaxel will allow patients to extend the time it takes for their disease to progress, and     also to improve their quality of life.   "
172454|NCT00097877|"     This trial is conducted in the United States of America (USA). The purpose of this study is     to test whether Biphasic Insulin Aspart 70/30 twice a day with Metformin improves glycemic     control vs. once daily Insulin Glargine with Metformin in subjects with Type 2 Diabetes who     are inadequately controlled on basal insulin plus oral anti-diabetic therapy.   "
172455|NCT00097890|"     This study will determine the safety and effectiveness of the drug Replagal for treating     people with Fabry disease, an inherited metabolic disorder. In this disease, an enzyme called     alpha-galactosidase A, which normally breaks down a lipid (fatty substance) known as     ceramidetrihexoside, is missing or does not function properly. As a result, the lipid     accumulates in the body, causing problems with the kidneys, heart, nerves, and blood vessels.     This study will examine whether replacing the missing alpha-galactosidase A with a     genetically engineered form of the enzyme called Replagal can reverse the illness.      Patients with Fabry disease who are 18 years of age or older and have completed 10 weeks of     Replagal therapy as participants in protocol TKT027 may be eligible for this 6-month study     extension.      Participants undergo the following tests and procedures:        -  Intravenous (IV) infusions of Replagal every other week over 25 weeks for a total of 13          infusions, with close monitoring during and after the infusions.        -  Brief safety evaluations at the time of each infusion, including a check of vital signs          (blood pressure, pulse, breathing rate, temperature), review of any side effects, and          review of medications.        -  Comprehensive evaluations at baseline (before starting Replagal therapy), after 13 and          25 weeks of therapy, and 30 days after completing therapy. These include a medical          history and physical examination, symptoms and pain questionnaire, blood and urine          tests, check of vital signs, electrocardiogram (EKG), 2-hour Holter monitor, and sweat          test (QSART).   "
172456|NCT00097903|"     The purpose of this study is to determine the maximum safe dose of orally administered     Karenitecin (BNP1350) in patients with solid tumors.   "
172598|NCT00102336|"     The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of     thrombocytopenia in subjects with ITP as measured by the platelet response. This study will     also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to     treatment with AMG 531.   "
172457|NCT00097916|"     About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation.     There are drawbacks associated with the currently available therapeutic interventions for     agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients     with moderate to severe AD treated with memantine, there were fewer incidences of agitation.     It is hypothesized that memantine will be effective in reducing the symptoms of agitation     associated with moderate to severe Alzheimer's Disease.   "
172458|NCT00097929|"     A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral     investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.   "
172459|NCT00097942|"     Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms     associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of     schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized     that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving     signal to noise ratio and thereby improving cognitive symptoms.   "
172460|NCT00097955|"     Study of the efficacy and safety of aliskiren when added to losartan and optimal     antihypertensive therapy in patients with hypertension, type 2 diabetes, and kidney disorders     to monitor improvement in any of these conditions.   "
172461|NCT00097968|"     Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection     that can happen after heart transplantation.      It is usually used in combination with other immunosuppressive drugs such as cyclosporine.     The purpose of this study is to evaluate the change in kidney function after beginning     everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with     everolimus, in adult cardiac transplant patients who have had their transplanted heart for at     least 1 year and who have cardiac allograft vasculopathy.   "
172462|NCT00097981|"     The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL     (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in     treating newly diagnosed patients with multiple myeloma. The number of patients whose     multiple myeloma disappears for a period of time (complete Response) will be studied to make     the determination of which treatment is more effective.   "
172463|NCT00097994|"     The purpose of this study is to follow a woman's progression through menopause in order to     examine the effects on health related quality of life and use of health care resources, and     to understand how women are using alternative therapies.   "
172464|NCT00098007|"     The study is designed to evaluate whether Neoral dose optimization together with a     therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the     pivotal cardiac trial while maintaining the efficacy.      This objective will be assessed by comparing renal function post-transplant between 2 groups     of patients.   "
172465|NCT00098020|"     Retinoids are analogues of vitamin A that regulate cellular differentiation, leading to     therapeutic use in skin disease and malignancy. In animal models of kidney disease, retinoids     restore podocyte phenotype toward normal and reduce proteinuria. The objective of this phase     II trial is to evaluate safety and develop preliminary evidence of efficacy of retinoid     treatment in patients with podocyte disease. The study is an open-label trial of isotretinoin     (13-cis retinoic acid). The study will be performed under the auspices of an IND from the     FDA. We will enroll 10 adult patients with biopsy-proven minimal change disease (MCD), focal     segmental glomerulosclerosis (FSGS), or collapsing glomerulopathy (CG). Inclusion criteria     will include a prior trial of immunosuppressive therapy and proteinuria greater than or equal     to 3.5 g/d while on angiotensin antagonist therapy.      The duration of the trial will be 6 months with possible additional 6-month extension for     patients who only develop partial response (PR) or limited response (LR). Those who have     complete response (CR) will continue the treatment for one additional month, for no more than     7 months total. Non-responders will stop at the end of 6 months. The primary clinical     endpoint will be reduction in proteinuria as compared to the baseline value assessed by     paired t test. The secondary clinical endpoints will be the fraction of patients who achieve     (CR) or (PR) at 6 months and at one year, confirmed on urine collections four weeks apart.     Retinoid therapy will be discontinued at the time a CR is confirmed, one month after the     first detection of CR. Follow-up will last one year after cessation of drug therapy. Patients     who have had CR or PR, but experience a relapse with greater than 3.5 g/d proteinuria during     follow-up will be eligible for further retinoid therapy.      All Participants will have an option of undergoing two research kidney biopsies: 1) at     baseline, unless renal biopsy has been done within 24 weeks of enrollment and 2) when the     diagnosis of CR or increased proteinuria is confirmed or alternatively upon completing 6     months of therapy (patients who exit the trial before 6 months due to non-renal adverse     events will not undergo renal biopsy) or; 3) when one year of therapy is completed for those     undergoing 6-month extension. Histologic endpoints will include change in linear extent     podocyte foot process effacement, extent of podocyte proliferation, and expression of     podocyte genes at the RNA and protein levels. Laboratory endpoints will include serum and     urine cytokine levels and urine levels of podocyte proteins, including nephrin. Toxicity     screening will include serum and urine chemistries, psychological profiles, radiographic     films of cervical, thoracic spines and calcanei, and bone mass assessment with dual photon     excitation absorptiometry (DEXA) at spine and hip.   "
172466|NCT00098033|"     The goals and objectives of this project are to evaluate the antileukemic activity of the     investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute     lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic     phases.   "
172467|NCT00098046|"     Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is     usually a self-limiting illness characterized by fever and a rash. Serious complications can     include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is     not a standard of care in immunocompetent children, but is recommended whenever a risk of     complication exists. This study will evaluate the safety and blood levels of a new     formulation of famciclovir in children 1-12 years of age.   "
172468|NCT00098059|"     This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir     in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir     (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive     multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess     safety and tolerability. Part B will start only after PK data from Part A had been analyzed.   "
172469|NCT00098072|"     This study will examine and test healthy volunteers and patients with pulmonary hypertension     to try to learn more about the disease and find better ways to detect, treat, and, if     possible, slow progression. Pulmonary hypertension is a rare blood vessel disorder of the     lung in which the pressure in the pulmonary artery (the blood vessel that leads from the     heart to the lungs) rises above normal levels and may become life-threatening.      Normal volunteers and patients with pulmonary hypertension 18 years of age and older may be     eligible for this study. All candidates are screened with a review of their medical records.     Normal volunteers also have a medical history, electrocardiogram, echocardiogram (heart     ultrasound), and pulmonary function test, in which the subject breathes in and out of a tube     that measures lung volume, mechanics and function.      All participants undergo the following tests and procedures:        -  Echocardiogram to measure heart function and blood pressure in the lungs. A small probe          held against the chest uses sound waves to obtain pictures of the heart.        -  Magnetic resonance imaging (MRI) to evaluate the heart's pumping action. Subjects lie on          a stretcher that slides into a long, tube-shaped scanner. The machine uses a magnetic          field and radio waves to obtain images of the heart.        -  6-minute walk to measure how far the subject can walk in 6 minutes. Subjects walk around          the hospital for 6 minutes at a comfortable pace.        -  Exercise testing to measure the ability to exercise and the subject's oxygen levels          during exercise. Subjects exercise on a bike or treadmill while the oxygen and carbon          dioxide they breathe are measured using a small device placed in the mouth.        -  Right heart catheterization to measure pressure in the heart and lungs. A small catheter          (plastic tube) is placed in an arm vein. A longer catheter called a central line is          placed in a deeper vein in the neck or just below the neck, or in the leg or arm. A          long, thin catheter that measures blood pressure directly is then inserted into the vein          and advanced through the chambers of the heart into the lung artery to measure all the          pressures in the heart and obtain blood samples.        -  Genetic and protein studies. DNA, RNA, and proteins from blood samples are studied for          genes and proteins that might predict the development or progression of pulmonary          hypertension.      In addition to the above, patients whose pulmonary hypertension was caused by a blood vessel     injury undergo the tests described below. The right heart catheter inserted for the     catheterization procedure remains in place to obtain measurements of the effects of nitric     oxide and nitrite in the following procedures:        -  Inhalation of nitric oxide (a gas naturally produced by cells lining arteries) at          30-minute intervals to examine its effect on lung and heart pressures.        -  Inhalation of aerosolized nitrite at 5-minute intervals to measure its effects on lung          and heart pressures.        -  Inhalation of nitric oxide for up to 24 hours to obtain multiple measurements of its          effect on lung and heart pressures.        -  Blood draws for laboratory tests.      In patients whose pulmonary hypertension was caused by a blood vessel injury, we also plan to     follow response to standard therapy. After the initiation of standard therapy, we will     restudy the same parameters (excluding NO and sodium nitrite studies) in these patients at     approximately 4 months, and yearly for 5 years   "
172470|NCT00100594|"     The purpose of this study is to determine the safety, effectiveness, and tolerability of the     anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV infected     people in Wenxi County, Shanxi Province, China.   "
172471|NCT00100607|"     This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone     mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with     osteoporosis.   "
172599|NCT00102349|"     The purpose of this study is to test two strategies to reduce the risk of contracting Human     Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) by reducing risk behaviors in     patients undergoing drug detoxification.   "
172472|NCT00100620|"     The intake of high doses of corticosteroids is known to play an important role in the     weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is     a drug known for its protective effect in some bone diseases (tumors, paget). This study will     test the safety and efficacy of zoledronic acid in the prevention and treatment of     corticosteroid induced osteoporosis in male and female patients.   "
172473|NCT00100633|"     The purpose of the study is to determine the safety of and immune response to a hepatitis B     virus vaccine series given with a boosting agent, CpG7909 oligodeoxynucleotides (ODN), in HIV     infected and HIV uninfected individuals who previously failed to develop a response to     hepatitis B vaccine.      Study hypothesis: Administration of CpG7909 ODN together with recombinant hepatitis B vaccine     will result in increased frequency and magnitude of response to vaccine in individuals who     have previously failed to mount a response to vaccination, and that in HIV infected subjects     with detectable plasma viremia, it will lead to the enhancement of HIV-specific responses.   "
172474|NCT00100646|"     HIV infected people often must take anti-HIV drugs for long periods, leading to long-term     drug exposure and toxicity. Interruptions in anti-HIV therapy, also known as structured     treatment interruptions (STIs), may have few negative health effects and may be helpful to     the overall long-term health of HIV-infected people. The purpose of this study is to     determine if sequential short-term STIs of antiretroviral therapy (ART) in HIV infected     individuals in a resource-constrained environment can retain the immune reconstitution     benefits of continuous treatment while potentially lessening rates of toxicity associated     with continuous therapy strategies and at the same time, lessen costs associated with ART.   "
172729|NCT00094250|"     This study is enrolling patients with congestive heart failure (CHF). The goal of the study     is to see if one of two carefully monitored exercise programs can improve the ability of     these patients to function and get about their activities.   "
172475|NCT00100659|"     The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a     (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic     hepatitis C virus (CHC) infection in children.      The purpose of this study is also to determine whether PEG-2a in combination with RV or     PEG-2a alone will result in a longer response rate in children with CHC.   "
172476|NCT00100672|"     The primary purpose of this study is to identify a dose of Liposome Entrapped c-raf Antisense     Oligonucleotide Easy-to-Use (LErafAON-ETU) which maximizes potential benefits of the compound     to patients with advanced cancer, without compromising their safety. This study will also     assess the processing of LErafAON-ETU by the body over time. Patients will receive an     intravenous infusion of LErafAON-ETU each week. Multiple blood samples will be taken for     pharmacokinetic analysis during the first treatment; two samples will be taken during both     the second and third treatments. Patients will be eligible to continue treatment until the     occurrence of unacceptable toxicity or disease progression.      In LErafAON-ETU, antisense oligonucleotides specific to c-raf, are associated with liposomes,     which are microscopic membrane-like structures created from lipids (fats). Raf-1 is a protein     which plays a critical role in many aspects of cellular activation and growth. Therefore, it     is thought to be an important factor that may support tumor development. LErafAON-ETU     potentially limits the ability of a cell to produce the Raf-1 protein.   "
172477|NCT00100685|"     This clinical trial is being conducted to determine tumor response and preliminary safety of     a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) and     is required for the establishment of new blood vessels during tumor growth, a process known     as angiogenesis.   "
172478|NCT00100698|"     This study will investigate long-term, low-dose growth hormone administration in HIV-infected     patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We     hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will     include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood     pressure,bone density, cardiovascular risk and safety parameters.   "
172479|NCT00100711|"     The primary purpose of this study is to determine if motexafin gadolinium may be an effective     treatment for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma     (SLL). Secondly, the duration of response and the time during which patients survive without     chronic lymphocytic leukemia or small lymphocytic lymphoma worsening will be evaluated.     Additionally, the patient's response to motexafin gadolinium will be compared to the response     of the patient's cells in a laboratory to motexafin gadolinium.   "
172480|NCT00100724|"     The purpose of this study is to assess the safety and immunogenicity of rPA102 vaccine given     intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels.   "
172481|NCT00100737|"     The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8     weeks in combination with rituximab is effective and safe when compared to rituximab given     alone in the treatment of follicular NHL subjects that have never received rituximab as a     treatment and are refractory or relapsed after previous chemotherapy.   "
172482|NCT00100750|"     This phase I/II trial is studying the side effects and best dose of tipifarnib when given     together with gemcitabine hydrochloride and to see how well they work in treating women with     breast cancer that has spread to other parts of the body. Tipifarnib is a drug that binds to     specific proteins on the tumor cells and then kills these cells. Gemcitabine hydrochloride is     a chemotherapy drug that may kill tumor cells by preventing cells from dividing. Giving     tipifarnib together with gemcitabine hydrochloride may kill more tumor cells.   "
172483|NCT00100776|"     The purposes of this study are to assess the efficacy, safety, and side effects among doses     approved by the Food and Drug Administration and higher (not FDA approved) doses of     olanzapine in patients with schizophrenia or schizoaffective disorder.   "
172484|NCT00100789|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel     works in treating patients with persistent, recurrent, or metastatic head and neck cancer.   "
172485|NCT00100802|"     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     radiation therapy together with temozolomide and lomustine after surgery may kill any     remaining tumor cells.      PURPOSE: This phase II trial is studying how well giving radiation therapy together with     temozolomide and lomustine works in treating young patients with newly diagnosed gliomas.   "
172486|NCT00100815|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to     the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine     together with bevacizumab works in treating patients with metastatic or unresectable     pancreatic cancer.   "
172487|NCT00100828|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with     metastatic or inoperable thyroid cancer.   "
172488|NCT00100841|"     Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability     of tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer     by blocking blood flow to the tumor. Giving combination chemotherapy together with     bevacizumab and cetuximab may kill more tumor cells. This phase II trial is studying how well     giving combination chemotherapy together with bevacizumab and cetuximab works in treating     patients with stage IV colorectal cancer that cannot be removed by surgery.   "
172489|NCT00100854|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Estrogen can cause the growth of non-small cell lung cancer cells.     Hormone therapy using fulvestrant may fight non-small cell lung cancer by lowering the amount     of estrogen the body makes. Giving erlotinib together with fulvestrant may kill more tumor     cells. It is not yet known whether giving erlotinib together with fulvestrant is more     effective than erlotinib alone in treating non-small cell lung cancer.      PURPOSE: This randomized phase II trial is studying giving erlotinib together with     fulvestrant to see how well it works compared to erlotinib alone in treating patients with     stage IIIB or stage IV non-small cell lung cancer.   "
172490|NCT00100867|"     In clinical trials being conducted throughout the world, pregnant HIV-infected women are     given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child     transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown.     The purpose of this study is to determine the safety, toxicity, and potential side effects of     maternal anti-HIV treatment on infants born to these HIV-infected women.      Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in     diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding     periods, and are not associated with adverse side effects to the fetus, neonate, and/or     breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV     transmission.   "
172491|NCT00100880|"     This phase I trial is studying the side effects and best dose of lenalidomide in treating     young patients with recurrent, progressive, or refractory CNS tumors. Lenalidomide may stop     the growth of CNS tumors by blocking blood flow to the tumor. It may also stimulate the     immune system in different ways and stop tumor cells from growing.   "
172492|NCT00100893|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of IH636 grape seed extract may prevent breast cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed     extract in preventing breast cancer in postmenopausal women at risk of developing breast     cancer.   "
172493|NCT00100906|"     RATIONALE: Tretinoin may help cells that are involved in the body's immune response to work     better. Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells. Giving     tretinoin together with interleukin-2 may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well giving three different doses of     tretinoin together with interleukin-2 works in treating patients with stage IV kidney cancer.   "
172494|NCT00100919|"     This study will collect information on how people sense leg position and movement. The     findings may help scientists develop better ways to evaluate and treat joint problems.      Healthy adult volunteers between 21 and 40 years of age may be eligible for the study.     Candidates are screened with a brief questionnaire and examination to determine their     strength, flexibility, and sensation.      Participants sit on a specially designed chair, with their foot and leg placed in a     custom-made apparatus that controls knee and ankle movements. The skin is marked to indicate     the area of interest for ultrasound assessment of muscle. Subjects respond to joint position     changes for several trials. The procedure takes a maximum of 2.5 hours to complete.   "
172495|NCT00100932|"     This is a study of E7389 in patients with recurrent and/or metastatic Non-Small-Cell Lung     Cancer (NSCLC) who progressed during or after treatment with a platinum agent and another     chemotherapy.   "
172496|NCT00100945|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with     locally advanced esophageal cancer.   "
172497|NCT00100958|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of indole-3-carbinol may prevent cancer.      PURPOSE: This randomized phase I trial is studying the side effects and best dose of     indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in     healthy participants.   "
172498|NCT00100971|"     RATIONALE: Vaccines made from a person's white blood cells and cancer cells may make the body     build an effective immune response to kill cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with acute myeloid leukemia.   "
172499|NCT00100984|"     The main objective of this study is to compare the safety and efficacy of an enfuvirtide     containing regimen to a nucleoside combination regimen. Resistance information will also be     collected.   "
172600|NCT00102362|"     The purpose of this study is to examine the effectiveness of a 12-hour basic job-training     program designed to give drug abuse treatment patients the skills they need to find and     secure a job and set vocational goals and methods for locating employment. The intervention     to be evaluated is modeled after the Job Seekers' Workshop, which was manualized and has been     tested in trials.   "
172500|NCT00100997|"     RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. It may also stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of     17-N-allylamino-17-demethoxygeldanamycin in treating patients with chronic phase chronic     myelogenous leukemia that did not respond to imatinib mesylate.   "
172501|NCT00101010|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving rituximab together with combination chemotherapy may kill more     cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with combination     chemotherapy works in treating older patients with diffuse large B-cell lymphoma.   "
172502|NCT00101036|"     This phase II trial is studying how well lapatinib works in treating patients with locally     advanced or metastatic biliary tract or liver cancer that cannot be removed by surgery.     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth.   "
172503|NCT00101062|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by lowering the amount of estrogen the body makes.     Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. Giving letrozole with celecoxib may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well letrozole and celecoxib work in treating     postmenopausal women with locally advanced or metastatic breast cancer.   "
172504|NCT00101075|"     The goal of this clinical research study is to find out how effective oxaliplatin and     capecitabine are against advanced cancer of the salivary gland. The safety of this treatment     as well as how long the cancer responds or stays in a stable state due to the treatment will     also be studied.   "
172505|NCT00101088|"     This phase I trial is studying the side effects and best dose of temsirolimus when given with     imatinib mesylate in treating patients with chronic myelogenous leukemia. Drugs used in     chemotherapy, such as temsirolimus, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Giving temsirolimus with imatinib mesylate may kill more cancer cells   "
172506|NCT00101101|"     RATIONALE: Vaccines made from gene-modified cells and a person's cancer cells may make the     body build an effective immune response to kill cancer cells. Interleukin-2 (IL-2) may     stimulate the white blood cells to kill cancer cells. Giving booster vaccinations may make a     stronger immune response and prevent or delay the recurrence of cancer. Drugs used in     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more cancer cells. Giving vaccine therapy together with IL-2 after combination     chemotherapy may be a more effective treatment for mantle cell lymphoma.      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with IL-2     after combination chemotherapy works in treating patients with relapsed or de novo stage II,     stage III, or stage IV mantle cell lymphoma.   "
172507|NCT00101114|"     This phase II trial is studying how well giving sorafenib with interferon alfa works in     treating patients with metastatic or unresectable kidney cancer. Sorafenib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa     may interfere with the growth of tumor cells and slow the growth of kidney cancer. Sorafenib     may help interferon alfa work better by making tumor cells more sensitive to the drug   "
172508|NCT00101127|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the     number of immune cells found in bone marrow or peripheral blood and may help the immune     system recover from the side effects of chemotherapy. Giving docetaxel and gemcitabine     together with G-CSF or pegfilgrastim may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel and gemcitabine together     with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or     recurrent uterine leiomyosarcoma.   "
172509|NCT00101140|"     RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that     were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a     donor can make an immune response against the body's normal cells. Giving total-body     irradiation together with fludarabine, thiotepa, and antithymocyte globulin before transplant     may stop this from happening.      PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in     treating patients with acute myeloid leukemia in remission.   "
172510|NCT00101153|"     RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cytarabine and daunorubicin, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving tipifarnib together with cytarabine and daunorubicin may     kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when     given with cytarabine and daunorubicin in treating older patients with acute myeloid     leukemia.   "
172511|NCT00101166|"     The purpose of this study is to find out what effects (good and/or bad) this new cancer     vaccine has on the patient and their cancer, whether it is safe and whether it can help get     rid of their cancer (malignant melanoma). We want to check how the patient's immune system     reacts, both before and after the vaccine treatment.   "
172563|NCT00101881|"     The study compares the effectiveness of two fully approved shock waveforms (monophasic and     biphasic shock) commonly used to defibrillate (shock) patients with out-of-hospital cardiac     arrest due to a highly lethal rhythm problem (ventricular fibrillation). The purpose of the     study (hypothesis) is to determine if one waveform results in improved resuscitation,     admission alive to hospital, and discharge alive from hospital compared with the other.   "
172512|NCT00101179|"     MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving     MS-275 together with azacitidine may kill more cancer cells. This phase I trial is studying     the side effects and best dose of MS-275 when given together with azacitidine in treating     patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid     leukemia.   "
172513|NCT00101192|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Cetuximab may also help cisplatin     work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy,     such as cisplatin, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving cetuximab together with cisplatin     may be a better way to block tumor growth.      PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin     works in treating patients with advanced, persistent, or recurrent cervical cancer.   "
172730|NCT00094263|"     To use existing longitudinal data from the Chicago Heart Association and Western Electric     Company studies to examine adiposity in relation to heart failure, multimorbidity and to     examine heart rate in relation to incident diabetes.   "
172514|NCT00101205|"     This phase I trial is studying the side effects and best dose of oxaliplatin and etoposide in     treating young patients with recurrent or refractory solid tumors or lymphomas. Drugs used in     chemotherapy, such as oxaliplatin and etoposide, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may     also help etoposide work better by making cancer cells more sensitive to the drug. Giving     oxaliplatin together with etoposide may kill more cancer cells.   "
172515|NCT00101231|"     This phase I trial is studying the side effects and best dose of flavopiridol in treating     patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, or     chronic myelogenous leukemia. Drugs used in chemotherapy, such as flavopiridol, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing.   "
172516|NCT00101244|"     This phase I trial is studying the side effects and best dose of SB-715992 in treating     patients with metastatic or unresectable solid tumors or Hodgkin's or non-Hodgkin's lymphoma.     Drugs used in chemotherapy, such as SB-715992, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing   "
172517|NCT00101257|"     RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the     immune system in different ways and stop tumor cells from growing.      PURPOSE: This phase I trial is studying the side effects and best dose of cellular adoptive     immunotherapy in treating patients with stage III or stage IV ovarian cancer or primary     peritoneal cancer.   "
172518|NCT00101270|"     This phase I trial is studying the side effects and best dose of oxaliplatin when given     together with irinotecan in treating young patients with refractory solid tumors or     lymphomas. Drugs used in chemotherapy, such as oxaliplatin and irinotecan, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Oxaliplatin may help irinotecan kill more cancer cells by making cancer cells more     sensitive to the drug. Giving oxaliplatin together with irinotecan may kill more cancer     cells.   "
172519|NCT00101283|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with     gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating     malignant pleural mesothelioma.      PURPOSE: This randomized phase II trial is studying pemetrexed disodium with gemcitabine and     pemetrexed disodium with carboplatin to see how well the combinations work compared to     historical controls in treating patients with advanced malignant pleural mesothelioma.   "
172520|NCT00101296|"     Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. This phase I trial is studying the side effects and best dose of tipifarnib in     treating patients with relapsed or refractory acute myeloid leukemia   "
172521|NCT00101309|"     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body     build an effective immune response to kill tumor cells. Interleukin-2 (IL-2) may stimulate     the white blood cells to kill tumor cells. Biological therapies, such as cellular adoptive     immunotherapy, stimulate the immune system and stop tumor cells from growing. Giving vaccine     therapy with IL-2 may be a more effective treatment for Ewing's sarcoma or neuroblastoma.      PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given with     IL-2 in treating young patients with relapsed or refractory Ewing's sarcoma or neuroblastoma.   "
172522|NCT00101335|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of celecoxib may prevent or treat head and neck cancer.      PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works     compared to placebo in preventing head and neck cancer in patients with oral leukoplakia.   "
172523|NCT00101348|"     This randomized phase I/II trial studies the side effects, best way to give, and best dose of     erlotinib and bevacizumab when given with cetuximab and how well giving erlotinib and     cetuximab together with or without bevacizumab works in treating patients with metastatic or     unresectable kidney, colorectal, head and neck, pancreatic, or non-small cell lung cancer.     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Cetuximab and bevacizumab     may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib     together with cetuximab and/or bevacizumab may kill more tumor cells.   "
172564|NCT00101894|"     The purpose of this study is to characterize the safety and tolerability of AMG 706 plus     panitumumab when administered with either FOLFIRI or FOLFOX4 chemotherapy regimens. This is a     Phase 1b clinical study.   "
172565|NCT00101907|"     The purpose of this study is to characterize the safety and tolerability of AMG 706 plus     panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b     clinical study.   "
172524|NCT00101361|"     This study is designed to determine whether the use of oxandrolone, an anabolic steroid, can     heal pressure ulcers in persons with spinal cord injury (SCI). In a Feasibility Study, three     VA SCI Units will screen and randomize patients into treatment with oxandrolone or with     placebo. Eleven other sites will screen patients to determine eligibility but will not treat     patients with the agent. Following the Feasibility Study, all sites will participate in a     blinded, randomized treatment study. A total of 400 patients will be enrolled over a     four-year period. Any patient in a participating unit who has chronic SCI and a     difficult-to-heal pelvic ulcer will be eligible for the study if other entry criteria are     met. All enrolled patients will be followed for a period of 24 weeks to determine whether     their target pressure ulcers heal. Those who are healed will be followed for an additional     four weeks to determine whether the ulcer remains healed.   "
172569|NCT00101959|"     Brief Summary: 800 RRMS Subjects currently treated with Avonex or Copaxone will be randomized     to either continue on their current therapy or receive Rebif therapy. The subjects will be     followed for 2 years. The primary objective is to compare the time to worsening to a medium     level of concern as defined by the Canadian Multiple Sclerosis Working Group (CMSWG)     treatment optimization recommendations.   "
172525|NCT00101374|"     This study will evaluate the effect of leflunomide on the life cycle of a specific immune     cell called CD4+ T cell in HIV-infected patients. Leflunomide is approved by the Food and     Drug Administration for treating rheumatoid arthritis. It works by blocking cell division in     activated T cells. In HIV infection, the HIV virus causes increased activation of T cells.     The activated cells become infected and die. Activation may also cause the death of T cells     that are not infected with HIV. T cells are necessary for the body to fight infections and     cancer. This study will see if leflunomide can block T-cell division and possibly reduce the     number of cells that die, reduce the number of cells in which HIV can reproduce, and lead to     a lower level of HIV virus in the body.      HIV-infected patients between 18 and 65 years of age who have 1) HIV viral levels of 1,000     copies/mL or more, 2) a CD4+ T-cell count of 350 cells/mm3 or more, and 3) a CD4+ T-cell     count that has never been less than 200 cells/mm3 may be eligible for this study. Candidates     are screened with a medical history, physical examination, blood and urine tests, chest     x-ray, and electrocardiogram (EKG).      Participants are randomly assigned to take leflunomide or placebo (a substance with no active     ingredient) every day for 28 days. They come to the clinic three times during the first 29     days of the study (days 1, 15, and 29) for a physical examination and review of any drug side     effects. Patients taking placebo end their participation on day 29. Patients taking     leflunomide stop taking the drug on day 29 and begin taking cholestyramine three times a day     for 11 days out of the next 14 days to clear the leflunomide from their body. On day 43, they     return to the clinic to have their leflunomide level checked to make sure that only very     little or none of the drug remains in the body. If the level is low, patients end their     participation on or around day 57. If the level remains high, they repeat the cholestyramine     treatment.   "
172526|NCT00101387|"     The purpose of this study is to determine whether a form of electrical acupuncture, called     percutaneous electrical nerve stimulation (PENS), can reduce pain and disability in older     adults with chronic low back pain (LBP). This study will also determine the effects of     general conditioning and aerobic exercise (GCAE) on chronic LBP.   "
172527|NCT00101400|"     The purpose of this study is to evaluate the anti-cancer activity and safety of BAY43-9006     (Sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other     organs of body despite treatment that the patient has received so far.   "
172528|NCT00101413|"     The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long     the effect continues, if the patients receiving BAY43-9006 will live longer.        -  If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung          cancer.        -  If BAY43-9006 helps to slow the worsening of non-small cell lung cancer.        -  If BAY43-9006 prevents the growth of, or shrinks non-small cell lung tumors and/or their          metastases.   "
172529|NCT00101426|"     This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase     inhibitor in patients with diabetic sensorimotor polyneuropathy.   "
172530|NCT00101439|"     A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with     primary hypercholesterolemia (high cholesterol) after eating a meal that is high in     cholesterol. The primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the     cholesterol concentration of the chylomicron-containing Sf≥400 fraction following a     cholesterol-enriched test meal.   "
172531|NCT00101452|"     The purpose of this study is to determine the safety and effectiveness of     s-adenosyl-l-methionine (SAMe) in treating major depression.   "
172532|NCT00101465|"     The purpose of this study is to improve cardiovascular disease (CVD) outcomes in racial and     ethnic minorities in Hawaii.   "
172533|NCT00101478|"     The purpose of this study is to improve cardiovascular disease (CVD) outcomes in racial and     ethnic minorities. Specifically, the study will aim to improve provider and patient     approaches to treatment of hypertension and diabetes, respectively.   "
172534|NCT00101491|"     The purpose of this study is to develop and test an intervention based on     literacy-appropriate electronic tools, tailored to the demographics and readiness for change     of the user, to promote tobacco smoking cessation in a low-literacy population.   "
172535|NCT00101504|"     The purpose of this study is to improve hypertension outcomes in racial and ethnic     minorities.   "
172536|NCT00101517|"     The purpose of this study is to improve cardiovascular disease (CVD) outcomes in racial and     ethnic minorities. Specifically, the study seeks to systematically characterize potential     ethnic differences in obesity-related CVD by drawing upon the fields of psychology,     physiology, biochemistry, nursing, and clinical medicine.   "
172537|NCT00101530|"     The purpose of the study is to improve cardiovascular disease (CVD) outcomes in racial and     ethnic minorities. Specifically, it seeks to improve the primary prevention of CVD in     Hispanics.   "
172566|NCT00101920|"     Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in     kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor     prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor     types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth.     Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal     antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a     Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in the treatment of     advanced NSCLC following failure of paclitaxel and carboplatin therapy on treatment arm 1 of     Immunex Protocol 054.0004 (Amgen Protocol 20025404), Part 2.   "
172567|NCT00101933|"     The purpose of this research is to study the safety and effectiveness of bilateral     stimulation of the anterior nucleus of the thalamus as adjunctive therapy for reducing the     frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset     seizures, with or without secondary generalization, that are refractory to antiepileptic     medications.   "
172568|NCT00101946|"     This study will evaluate the effectiveness and safety of the investigational drug 683699 in     treating subjects with moderately to severely active CD (Crohn's Disease).   "
172570|NCT00101972|"     RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them.      PURPOSE: This phase I trial is studying the side effects and best dose of RAV12 in treating     patients with metastatic or recurrent adenocarcinoma.   "
172571|NCT00101985|"     This study will evaluate the effectiveness and safety of the investigational drug talnetant     in treating subjects with irritable bowel syndrome (IBS).   "
172573|NCT00102011|"     RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors     find tumor cells early and plan better treatment for colorectal cancer.      PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works     compared to fecal occult blood test in screening healthy participants for colorectal cancer.   "
172538|NCT00101543|"     Conventional rehabilitation does not restore normal, safe gait to many stroke survivors.     Functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM)     improved persistent gait deficits for patients with chronic stroke (1-7 years post stroke),     but required a long protocol of 6-18 months. For chronic deficits, a shortened response to     treatment (3 months) was obtained by combining FNS-IM with body weight-supported treadmill     training (BWSTT). Gains included strength, coordination, gait kinematics, walking endurance,     and quality of life. Gait deficits treated in the chronic phase are more resistant to     treatment than in the early recovery phase, because chronic, abnormal movement patterns are     more ingrained. Therefore, during the early recovery phase, it is likely that a relatively     greater treatment response will be obtained. The purpose of the proposed work is to test the     combination FNS-IM + BWSTT during the early recovery phase following stroke. Hypothesis I is:     FNS-IM + BWSTT will restore volitional gait more completely for subjects during the early     recovery phase following stroke, compared to BWSTT alone. Subjects will be admitted at 1-11     months after stroke. Thirty five subjects will be randomized to one of the two treatment     groups. They will be treated for 48 sessions, four sessions/week. Primary outcome measures     will be: kinematic swing phase gait components, energy cost of gait, and an index of walking     endurance. Secondary outcome measures will be kinematic stance phase gait components and gait     speed. The second set of hypotheses will test the relationship between restoration of     mobility and measurements of impairment, function and quality of life.   "
172539|NCT00101569|"     The purpose of this trial is to study liquid aripiprazole in patients with stable     schizophrenia.   "
172540|NCT00101582|"     The purpose of this research study is to test the safety and effectiveness of palifermin to     determine if weekly doses can be safely administered to reduce the incidence (occurrence of),     duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in     the mouth). Mucositis is a common side effect for patients receiving chemotherapy     (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and     neck cancer (HNC).   "
172541|NCT00101595|"     The purpose of this clinical research study is to learn if BMS-354825 will have activity as     defined by hematologic responses in subjects with lymphoid blast phase chronic myeloid     leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia with primary     or acquired resistance to imatinib mesylate.   "
172542|NCT00101608|"     The purpose of this clinical research study is to learn if vinflunine can shrink or slow the     growth of the cancer or increase survival in patients with transitional cell carcinoma of the     urothelium. The safety of this treatment will also be studied.   "
172543|NCT00101621|"     M40403 was found to be effective in reducing pain in animal models and in clinical studies of     subjects who were experiencing pain after dental surgery. The proposed study is designed to     investigate the efficacy and safety of M40403 when co-administered with an opioid in subjects     with pain due to cancer.   "
172544|NCT00101634|"     The purpose of this study is to determine the efficacy (how well the drug works), safety, and     side effects of paliperidone palmitate compared to placebo in the treatment of the symptoms     of schizophrenia in adults. The placebo used in this study was a nutritional substance known     as 20% Intralipid emulsion given to patients requiring intravenous feedings.   "
172545|NCT00101647|"     The purpose of this clinical research study is to learn if BMS-354825 will have activity,     defined by hematologic response, in subjects who have accelerated phase chronic myeloid     leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this     treatment will also be studied.   "
172546|NCT00101660|"     The purpose of this study is assess the effects of the investigational drug dasatinib on     participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and     who are either resistant to or intolerant of imatinib. Other purposes of the study are to     identify any side effects the drug may produce and to study the level of dasatanib in the     blood and assess the efficacy of dasatanib in the treatment of leukemia.   "
172547|NCT00101673|"     This study was not conducted in the United States. The purpose of this study was to assess     the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering     overall blood glucose levels in people with type 2 diabetes who had not previously been     treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a     specified range.   "
172548|NCT00101686|"     This study compares in the first study period combination of Irinotecan with three different     methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second     period of study it compares FOLFIRI [a chemotherapy regime that combines bolus irinotecan and     leucovorin [LV] with infusional 5-fluorouracil (5-FU)] + bevacizumab and mlFL + bevacizumab.     Measures of efficacy and safety will be reported.   "
172549|NCT00101699|"     The purpose of this study is to examine the way soy consumption affects menopausal symptoms     in middle-aged Japanese women.   "
172550|NCT00101712|"     This study is not being conducted in the United States. Key long-term clinical studies have     shown that people with type 2 diabetes should try to achieve overall blood glucose levels as     close to normal as possible. The purpose of this study is to assess the safety and     effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall     blood glucose levels in people with type 2 diabetes who have not been previously treated with     drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.   "
172551|NCT00101725|"     This study is designed to evaluate the safety and effectiveness of an investigational drug,     TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome     (IBS).   "
172552|NCT00101738|"     The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have     comparable kidney function results in kidney transplant patients.   "
172553|NCT00101751|"     This trial is conducted in the United States of America (USA). The purpose of this study is     to compare the effectiveness and safety of a biphasic insulin aspart standard titration     regimen when coupled with dietary intervention to standard titration without dietary     intervention.   "
172587|NCT00102193|"     The purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn     Apheresis System to treat the signs and symptoms of ulcerative colitis.   "
172731|NCT00094276|"     This study will evaluate two interventions that are designed to reduce asthma morbidity and     improve asthma care of children in Head Start in urban Baltimore.   "
172554|NCT00101764|"     The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be     a promising treatment for a variety of ocular diseases associated with inflammation. To date,     the only drug available, Kenalog-40 Injection produced by Bristol Myers Squibb, has not     been formulated for intraocular use.      The purpose of this study is to evaluate the long-term safety and potential efficacy of novel     intravitreal injections of a preservative-free formulation of triamcinolone acetonide     (TAC-PF) at two dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of     TAC-PF at 20 mg.      The study will be a masked, randomized Phase I study that will enroll 120 participants with     one of the following diseases: age-related macular degeneration (AMD), diabetic macular edema     (DME), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), or any     other retinal disease with associated macular edema. At least 21 participants will be     enrolled in the four designated disease strata: AMD, DME, CRVO, and BRVO. The remaining 36     participants may have one of these diseases or may be enrolled with another retinal disease.     Within each disease strata, at least seven participants will be randomized to each dosing     group. The participants will be randomly assigned to one of the three treatment groups.      The primary outcome will be an assessment of post-injection intraocular toxicity-related     events during the 3-year follow-up, including cataract formation, development of glaucoma,     and any adverse event preventing retreatment. The secondary outcomes will be an improvement     in best-corrected visual acuity (BCVA, EVA) and decreases in retinal thickening and area of     leakage, from baseline to year 1.   "
172555|NCT00101777|"     The importance of the proposed research project derives from a steady accumulation of     research findings on the relationship between respiration and anxiety. The relationship     between panic disorder and abnormalities in respiration has been recognized for more than 10     years. Increased sensitivity to CO2 exposure in panic disorder represents the most consistent     finding supporting this relationship. The current proposal follows naturally from three sets     of recent research findings in the area of panic disorder. First, our group has recently     shown that children with anxiety disorders, like adults with panic disorder, exhibit     increased sensitivity to CO2. Second, other researchers have shown that psychiatrically     healthy relatives of patients with panic disorder also exhibit increased sensitvity to CO2.     Finally, our group has also recently shown that children of adults with panic disorder     exhibit high rates of anxiety disorders, particularly separation anxiety disorder, the     childhood anxiety disorder which exhibits the highest degree of CO2 sensitivity. These three     findings suggest that children of parents with panic disorder may exhibit a latent     vulnerability to panic disorder, manifested as increased sensitivity to CO2.      A secondary feature of the proposed research project derives from a steady accumulation of     research findings in basic science literature outlining the parts of the brain that mediate     fear and anxiety in animals. It may be possible to use insights from research on the brain     basis of fear in animals to develop methods for assessing the brain basis of fear in humans.     Moreover, work in animals notes changes in brain systems that mediate fear and anxiety across     development. If development. If developmentally sensitive methods could be used to study fear     in children, it may also be possible to greatly enhance our understanding of the manner in     which the relationship between brain function and fear changes as children age. If     similarities could be demonstrated across animals and humans in these areas, new insights on     potential treatments for anxiety could be more readily transferred from the laboratory to the     clinic. A second goal of the current proposal is to refine two neuropsychological probes that     are thought to assess functional aspects of brain systems implicated in fear and anxiety     across various species, from rodents to humans.   "
172556|NCT00101790|"     The purpose of this study is to determine the test dose of pamidronate for treatment of low     back pain in terms of safety, tolerability, and pain relief.   "
172557|NCT00101803|"     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a     single oral drug. The purpose of this study is to assess the safety and effectiveness of the     combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood     glucose levels in people with type 2 diabetes who have not previously been treated with drug     therapy to lower their blood sugar.   "
172558|NCT00101816|"     The purpose of this study is to see what effect an investigational drug (BMS-354825) has on     subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and     who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study     is to see what side effects this drug may have on subjects.   "
172559|NCT00101829|"     The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in     treating patients with Sjogren's syndrome (SS). Rituximab is a laboratory-made antibody     currently used to treat some kinds of lymphoma. Rituximab may also help people with SS, a     disease of the immune system. However, the safety of rituximab in SS patients must first be     established.   "
172560|NCT00101842|"     The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and     Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic     transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and     Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated     with the combination of these drugs; To determine whether Gemcitabine and Platinol followed     by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To     determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make     your tumor smaller or disappear, and for how long.   "
172561|NCT00101855|"     This study is a randomized controlled trial of an evidence based, patient specific web site's     ability to improve preventive practices in pediatric care. Parents visit the website within 2     weeks of a scheduled well child visit and are presented with a menu of age specific topics     that they can read about as they wish.   "
172562|NCT00101868|"     The transition from hospital to home is a high-risk period in a patient's illness. Poor     communication between healthcare providers at hospital discharge is common and contributes to     adverse events affecting patients after discharge. The importance of good communication at     discharge will increase as more primary care providers delegate inpatient care to     hospitalists. Any process that improves information transfer among providers at discharge     might improve the health and safety of patients discharged from U.S. hospitals each year, and     to appreciably reduce unnecessary healthcare expenditures. Information transfer among     healthcare providers and their patients can be undermined because of inaccuracies, omissions,     illegibility, logistical failure (e.g., information is never delivered), and delays in     generation (i.e., dictation or transcription) or transmission. Root causes include recall     error, increased physician workloads, interface failures (e.g., physician-clerical) and poor     training of physicians in the discharge process. Many of the deficiencies in the current     process of information transfer at hospital discharge could be effectively addressed by the     application of information technology. The proposed study will measure the value of a     software application to facilitate information transfer at hospital discharge. The study is     designed to compare the benefits of discharge health information technology versus usual care     in high-risk patients recently discharged from acute care hospitalization. The design is a     randomized, single-blind, controlled trial. The outcomes are readmission within 6 months,     adverse events, and effectiveness and satisfaction with the discharge process from the     patient and physician perspectives. The cost outcome is the physician time required to use     the discharge software.   "
172574|NCT00102024|"     This is a Phase I/II open-label, dose-escalating study in patients with metastatic colorectal     cancer. The objectives of the study are to obtain information on the safety of radiolabeled     IDEC-159, as well as its activity in colorectal cancer. Another objective is to determine the     maximum tolerated dose (MTD). The study duration is 2 years with visits occuring daily and/or     weekly for the first 3 months, and every 6 weeks until the end of the 2 year period.   "
172575|NCT00102037|"     This trial is conducted in the United States of America (USA). The purpose of this clinical     research trial is to understand how safe and effective Recombinant Activated FVII is for     reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.   "
172576|NCT00102050|"     NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a     primary early stage indication of peripheral arterial disease (PAD). This trial is designed     to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 taken twice a day (BID) for 24     weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of     Intermittent Claudication.   "
172577|NCT00102063|"     The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent     patients with schizophrenia for a period of at least 6 weeks.   "
172578|NCT00102076|"     One of the principal safeguards mandated by the Federal Regulations governing clinical     research with children is the assent requirement: children who are capable must provide an     affirmative agreement to participate unless the research holds out a prospect of direct     benefit that is important to the health or well-being of the children and is available only     in the context of the research (46.408). Despite the importance of the assent requirement,     the Federal regulations offer no guidelines on its implementation. In the present study, we     propose to survey children and one of their parents in order to obtain information concerning     children's role in making decisions concerning their participation in clinical research. Five     elements of children's involvement in the decision-making process with respect to their     participation in clinical research will be assessed: 1) receipt of information concerning the     available options; 2) understanding of this information; 3) assessment of the available     options; 4) expression of a preferred option; and 5) coordination with parental     decision-making.      Three groups will be enrolled: 1. Minor/Parent pairs where the minor is participating in, or     is in follow-up for, a drug treatment research study for cancer 2. Minor/Parent pairs where     the minor is participating in, or is in follow-up for, a drug treatment research study for     asthma, and 3. Minor/Parent pairs where the minor is receiving on-going clinical care for     asthma. Children 7-14 years of age will be enrolled. Total enrollment will be 400 subject     pairs, approximately 150 in cancer research, 150 in asthma research and 100 involved in     clinical care for asthma, with approximate balance between the sites. Two formalized survey     instruments - research/clinical minor, research/clinical parent - will be developed in     consultation with Research Triangle Institute (RTI).   "
172579|NCT00102089|"     This study will test the safety and side effects of an experimental vaccine booster against     HIV. A vaccine is a substance given to try to create immunity or resistance to a disease or     infection. The vaccine used in this study is called VRC-HIVADV014-00-VP. It is made from an     adenovirus (a common virus that causes upper respiratory infections) that contains DNA     (genetic material) of three HIV proteins. Injected into a human, the viral DNA instructs the     body to make small amounts of some HIV proteins. VRC-HIVADV014-00-VP will be given to people     who previously received a vaccine called VRC-HIVDNA009-00-VP under NIH protocol 03-I-0022.     Important: Study participants cannot catch an adenovirus infection or HIV or AIDS from the     vaccine or any proteins made from it.      Healthy normal volunteers who participated in NIH protocol 03-I-0022 may be eligible for this     study. They must have completed three injections of 4 mg or 8 mg of VRC-HIVDNA009-00-VP     without experiencing a serious side effect that was possibly related to the vaccine.     Candidates are screened with a medical history, clinical evaluation, blood and urine tests,     and HIV and pregnancy counseling.      Participants receive one injection of VRC-HIVADV014-00-VP the day they enroll in the study     (study day 0). They are observed for at least 30 minutes after immunization. At home, they     record their temperature and any symptoms they may experience, including any effects at the     injection site, for 5 days and call a study nurse 1 or 2 days after the injection. They     immediately report any symptoms to the clinic staff and, if necessary, come to the clinic for     an examination.      Participants have five additional clinic visits during the study, at weeks 2, 4, 6, 12 and     24, each lasting about 2 hours. At each visit, they are checked for health changes or     problems and are asked about medications they are taking. Blood is drawn for immune function     testing, HLA typing (a genetic test of immune system markers), and other genetic factors. A     urine sample is collected at some visits. Additional laboratory tests may be requested     between visits. Some participants may undergo apheresis at the week 4 visit to collect a     large number of white blood cells for laboratory tests to see how the immune system responds     to the study vaccine. For this procedure, blood is collected through a needle in an arm vein     and flows through a catheter (plastic tube) into a machine that separates it into its     components by centrifugation (spinning). The white cells are extracted and the rest of the     blood is returned through another needle in the other arm. The procedure takes about 1 to 3     hours.      Participants are tested three or more times for HIV and are questioned about their sexual     behavior and drug use. They complete a social impact questionnaire at week 24 that includes     questions about any problems they may have experienced from their participation in the study     regarding such things as insurance, health care, friends, family, employment, housing,     education, or government agencies.   "
172580|NCT00102102|"     This study will examine the role of substance P, a chemical messenger in the brain, in     post-traumatic stress disorder (PTSD), a chronic anxiety disorder. PTSD can develop after     exposure to a terrifying event or ordeal, such as a violent personal assault, natural or     human-caused disaster, accident, or military combat. Substance P is a peptide that may be     important in the response to certain psychiatric and neurological diseases and conditions,     including anxiety.      Healthy normal volunteers and people with PTSD who are between 18 and 65 years of age may be     eligible for this study. Candidates are screened with a physical examination, blood and urine     tests, pregnancy test for women who can become pregnant, and a neuropsychological evaluation.      Participants undergo positron emission tomography (PET) and magnetic resonance imaging (MRI)     scanning. An optional lumbar puncture (spinal tap) is also requested.      PET Scanning      PET uses small amounts of a radioactive chemical called a tracer that labels active areas     of the brain. The tracer used in this study is [18F]SPA-RQ. For the procedure, the subject     lies still on the scanner bed. A special mask is fitted to the head to help keep the     subject's head still during the scan so the images will be clear. A 20-minute transmission     scan is done before the radioactive tracer is injected to provide measures of the brain that     will help in the precise calculation of information from subsequent scans. After the tracer     is injected through a needle in the arm, pictures are taken continuously for about 2 hours.     Then, 20- to 40-minute images are taken every hour until about 5 hours after the injection.      MRI Scanning      An MRI scan is scheduled at some time within 1 year of the PET scan. MRI uses a magnetic     field and radio waves to obtain images of body tissues and organs. The subject lies still on     a table inside the tunnel-like MRI scanner. Earplugs are worn to muffle loud noises that     occur during the scanning. The maximum duration of the scan is 60 minutes.      Lumbar Puncture      Lumbar puncture is used to examine the cerebrospinal fluid (CSF) that surrounds both the     brain and the spinal cord. For this procedure, a local anesthetic is given to numb the skin     in the lower back area. A small needle is then inserted into the space between the bones in     the lower back where the CSF circulates below the spinal cord. A small amount of fluid is     collected through the needle.      Blood Draw      A blood sample is collected to generate cell lines that can be used to extract DNA (genetic     material) for gene studies and that can be frozen for future use.   "
172581|NCT00102115|"     The purpose of this study is to determine the safety and tolerability of Talaporfin Sodium     (LS11) Photodynamic Therapy in patients with late stage Age-Related Macular Disease (AMD).   "
172582|NCT00102128|"     Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells     removed from the thigh muscle) into scarred areas of heart muscle after heart attack.   "
172583|NCT00102141|"     The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8     weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the     relief of vasomotor symptoms and who have hypertension.   "
172584|NCT00102154|"     A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a     sleep disorder).   "
172585|NCT00102167|"     A study to evaluate the safety and effectiveness of Study of MK0928 in Healthy Adult     Volunteers in a Model of Insomnia for insomnia (a sleep disorder).   "
172586|NCT00102180|"     To investigate the relationship between the use of prescription drugs and the occurrence of     ventricular arrhythmia and sudden death.   "
172588|NCT00102206|"     HIV infected children and adolescents who have taken many anti-HIV drugs may have limited     treatment options and are at high risk for progressing to AIDS. The purpose of this study is     to determine whether an anti-HIV treatment regimen of 2 protease inhibitors (PIs) and 2     nucleoside reverse transcriptase inhibitors (NRTIs) is more effective than a regimen of 4     NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV     treatment.   "
172589|NCT00102219|"     This is a non-randomized Phase 2 study testing pemetrexed and doxorubicin in combination for     locally advanced or metastatic breast cancer. Both pemetrexed and doxorubicin have been     combined with other drugs, but they have not yet been combined with each other. It is     expected that the patient will benefit from the different mechanisms of action of the two     drugs. However, there is no guarantee that the patient will benefit from this treatment.   "
172590|NCT00102232|"     The purpose of this study is to determine whether supplementation with phosphatidylcholine     lowers plasma homocysteine concentrations in healthy men.   "
172604|NCT00102414|"     The primary objective of this study is to compare the time to progressive disease in patients     treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Patients will have     advanced epithelial ovarian cancer and have failed first-line platinum-containing therapy 6     months after treatment discontinuation.   "
172605|NCT00102427|"     The purpose of this study is to determine if primary care patients with panic and/or     generalized anxiety disorder can benefit from a telephone-based collaborative care     intervention.   "
172591|NCT00102245|"     This study will examine blood for factors that may cause or prevent diseases involving iron     or red blood cells. Iron is an important nutrient for human health that is needed to produce     red blood cells. Red blood cells carry oxygen to body tissues. A better understanding of iron     and red blood cells may help lead to better treatment of several diseases including anemia.      Patients of all ages with red cell abnormalities in the following categories may be eligible     for this study:        -  Diseases with deficiency, overload or maldistribution of iron        -  Known red blood cell diseases, such as anemias and hemoglobinopathies        -  Red blood cell diseases of unknown cause, such as hemolysis of unknown cause        -  Red blood cell abnormalities with no overt clinical disease, such as hereditary          persistence of fetal hemoglobin      Participants undergo the following procedures:        -  Medical history        -  Physical examination        -  Standard medical tests related to the individual's iron or red blood cell condition      Blood draw for the following purposes:        -  Testing for syphilis and for the hepatitis B and C, HIV, and HTLV-1viruses, and for a          pregnancy test for women who can become pregnant        -  Research purposes. This blood is analyzed for genes, proteins, sugars, and fat          molecules.   "
172592|NCT00102258|"     This study will determine whether adding more calories to the diet helps boys with growth     problems grow better while being treated with Nutropin, a growth hormone that is used to help     children grow taller. The Food and Drug Administration has approved Nutropin for use in     children who are very short. This study will examine whether giving nutritional supplements     in addition to Nutropin can help children grow better than with Nutropin alone.      Boys between 7 and 10 years of age who are very short and below average in weight, but are     otherwise healthy may be eligible for this study. Candidates must qualify for Nutropin     treatments to boost their growth. Boys will be recruited for the study from the Nemours     Children's Clinic in Jacksonville, FL, and from the National Institutes of Health in     Bethesda, MD.      Participants are randomly assigned to one of two treatment groups. One group is observed for     6 months and then receives a Nutropin injection every day for 12 months. The second group     drinks 8 ounces of a high-calorie beverage called Pediasure every day for 6 months and then     receives Nutropin plus Pediasure every day for 12 months. In addition to treatment,     participants undergo the following tests and procedures at the schedule indicated: Baseline,     3, 6, 9, 12, 15 and 18 months        -  Clinical examination        -  Height measurement        -  Body composition assessment: Skin-fold thickness calipers are used in four places on the          body to estimate body fat        -  Bioelectric impedance: A small amount of electrical current is used to calculate the          percentage of body fat.      Baseline, 6, 12, and 18 months        -  Blood tests        -  Bone age x-ray: x-ray of the left hand to measure growth potential        -  DEXA (dual energy x-ray absorptiometry) scan: x-ray scan to measure body fat, muscle,          and bone mineral content. The subject lies on a flat table during the scan.      Baseline, 6, and 12 months        -  Record of dietary intake: Parents are asked to write down everything the child eats and          drinks for 3 days. Using this record, a dietitian calculates the daily caloric intake.        -  Total energy expenditure: This test determines how much energy the child uses. For the          test, the child drinks water labeled with harmless isotopes (heavy oxygen and heavy          hydrogen). For the next 10 days he collects urine in plastic tubes at home. At the end          of the 10 days, the parents bring the urine to the clinic for analysis to determine how          fast the labeled water leaves the body. This information is used to calculate how much          energy the child expends each day.      Participants' weight is measured at 2 and 4 weeks, and then monthly for the remainder of the     18-month study.   "
172593|NCT00102271|"     This study will examine 1) how nitrite (a natural blood substance that relaxes blood vessels)     increases blood flow and lowers blood pressure, and 2) how to increase the effects of nitrite     on blood pressure.      Healthy volunteers between 21 and 40 years of age may be eligible for this study. They must     be non-smokers and have no history of high blood pressure, high cholesterol, or diabetes.     Candidates are screened with a medical history, physical examination, electrocardiogram, and     blood tests. This study is either done in the NIH Clinical Center intensive care unit or on     the general clinical ward. Participants are enrolled in Part A of the study. After completion     of Part A participants will be enrolled in Part B of the study.      Part A:      Participants lie in a reclining chair during the study. Small catheters (plastic tubes) are     inserted into an artery and vein in the forearm. Another tube is placed in the vein of the     opposite arm. Blood pressure cuffs are placed around the upper arm and wrist, and a strain     gauge (a rubber band-like device) is placed around the forearm. This device helps us to     measure blood flow through the arm. When the blood pressure cuffs are inflated, blood flows     into the forearm, stretching the strain gauge at a rate proportional to the blood flow.     Pressure cuffs and a strain gauge are also placed on the other arm. After 20 minutes, blood     pressure and blood flow are measured in both forearms. Then blood is drawn from the tube in     the right vein to measure blood counts, proteins, and other chemicals. Participants then are     given small doses of either saline, ascorbic acid, or a medicine called oxypurinol, a form of     a drug that is often taken to prevent gout. After 30 minutes, sodium nitrite is injected in     increasing doses into the artery for 30 minutes. Blood flow is measured and blood is drawn     every 5 minutes during the infusion. At the end of the 30 minutes, blood is drawn from the     vein every 30 minutes for 3 hours. After 3 hours, sodium nitrite infusions are restarted for     2 hours and blood flow is measured and samples collected every 30 minutes during this period.      Part B: Participants lie in a reclining chair during the study. A small catheter (plastic     tube) is placed in the artery of the left forearm to draw blood samples. A larger catheter     called a central line is placed in a deeper vein in the neck. Another tube is advanced     through the central line into the chambers of the heart, through the heart valve, and into     the lung artery to measure pressures in the heart and lungs. Blood is drawn after 30 minutes     to obtain baseline measurements. Then saline (sterile salt water) is put into the tube in the     lung artery. Blood pressure cuffs are placed around the upper arm and wrist, and a strain     gauge (a rubber band-like device) is placed around the forearm, which helps us to measure     flow through the arm. When the cuffs are inflated, blood flows into the forearm, stretching     the strain gauge at a rate proportional to the blood flow. Pressure cuffs and a strain gauge     are also placed on the other arm. After 20 minutes, blood pressure and blood flow are     measured in the forearm and blood samples are drawn from the tube in the left artery to     measure blood counts, proteins, and other chemicals.      Subjects then breathe a mixture of oxygen and nitrogen through a facemask for 30 minutes,     then room air for 30 minutes, and then the oxygen and nitrogen mixture for another 30     minutes. While breathing the mixture the second time, sodium nitrite is injected through the     tube in the artery in three increasing doses for 5 minutes each. Every 5 minutes during the     infusion blood is drawn from the tubes in the neck. Forearm blood flow is also measured every     5 minutes. After 30 minutes, the subject breathes room air for 3 hours and 15 minutes and     then the sodium nitrite is injected again in three increasing doses for 5 minutes each. Every     5 minutes during the infusion blood is taken from the tube in the neck and forearm blood flow     is measured   "
172594|NCT00102284|"     The purpose of this study is to determine whether levodopa, pergolid, rivastigmine, or     modafinil are effective in boosting semantic language acquisition in healthy subjects.   "
172595|NCT00102297|"     The Phase 1b study is a multi-center trial designed to test the safety, tolerability,     biologic activity of escalating doses of FG-3019 in up to 20 patients with type 1 or type 2     diabetes and microalbuminuria (early-stage kidney disease). Patients will receive either 3 or     10 mg/kg of FG-3019 administered every two weeks as an infusion for a total of four doses.     The ability of FG-3019 to reduce the excretion of protein in the urine is being measured as a     secondary endpoint.   "
172596|NCT00102310|"     The primary objective of this study will be to characterize the dose response profile of     YM443 in subjects with functional dyspepsia (FD) to enable the selection of doses for the     Phase 3 clinical trial.   "
172597|NCT00102323|"     The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of     thrombocytopenia in subjects with ITP as measured by the platelet response. This study will     also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to     treatment with AMG 531.   "
172602|NCT00102388|"     This study is not being conducted in the United States. The purpose of this study is to     assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to     gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have     not been previously treated with drug therapy to lower their blood sugar.   "
172603|NCT00102401|"     The overall goal of this study is to compare the impact of a new Internet Dyspnea     Self-Management Program (eDSMP) with an established face-to-face Dyspnea Self-Management     Program (DSMP) in patients with COPD. The primary aim of the study is to test the following     two hypotheses: 1. The eDSMP and the DSMP will have comparable improvements in the primary     outcomes of shortness of breath (dyspnea) with activities of daily living (ADL), exercise     adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6     months. 2. The eDSMP and the DSMP will have comparable improvements in the secondary outcomes     of perception of support, self-efficacy for exercise and managing dyspnea, and health     resource utilization at 3 and 6 months. This study is a randomized, longitudinal, repeated     measures design with measurement times at 0, 3, and 6 months.   "
172607|NCT00102453|"     In this study, the primary aim will be to estimate the magnitude and variability of strength     change over time that may be expected for subjects on the study treatment. This estimate of     effect will allow us to develop a rigorous statistical plan in the future randomized study.     The specific estimation technique to be applied will use a linear random effects model to     estimate average strength change during the 3-month lead-in period and then during the     twelve-month treatment period, taking into account the quantitative muscle testing (QMT)     measures for each subject. Accounting for the correlation between repeated measures from each     subject by using a random effects model will yield an unbiased estimate of variability for     the population average change in strength. We will use an analysis of pre- and post-treatment     data to inform a best estimate of treatment effect. For example, the difference in QMT trends     pre- and post-treatment would provide a straightforward measure of efficacy.   "
172608|NCT00102466|"     This study is not being conducted in the United States. Many people with type 2 diabetes     cannot maintain target blood glucose levels when taking a single oral drug. The purpose of     this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug,     compared to that of gliclazide in lowering overall blood glucose levels when added to     metformin in people with type 2 diabetes not at target blood glucose levels on metformin     alone.   "
172609|NCT00102479|"     The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of     aripiprazole tablets following oral administration to children and adolescents.   "
172610|NCT00102492|"     This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of     GW679769 in subjects with major depressive disorder.   "
172611|NCT00102505|"     The purpose of the study is to determine the dose limiting toxicities and maximum tolerated     dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with     Non-small Cell Lung Cancer.      A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin     treatment followed by 2 weeks without treatment.      Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of     docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor     response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may     stay on the study a maximum of 6 cycles.   "
172612|NCT00102518|"     The purpose of this study is to test the long-term safety and tolerability of aripiprazole in     adolescent patients with schizophrenia, and child and adolescent patients with bipolar I     disorder, manic or mixed episode.   "
172613|NCT00102531|"     Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated     dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients     with relapsed/progressive osteosarcoma metastatic to the lung.   "
172614|NCT00102544|"     This study will evaluate the accuracy and effectiveness of an experimental tracking device     for locating abnormalities during invasive procedures, such as biopsy or ablation, that     cannot easily be visualized by usual imaging techniques, such as computed tomography (CT)     scans or ultrasound. Some lesions, such as certain liver or kidney tumors, small endocrine     abnormalities, and others, may be hard to find or only visible for a few seconds. The new     method uses a needle with a miniature tracking device buried inside the metal that tells     where the tip of the needle is located, somewhat like a mini GPS, or global positioning     system. It uses a very weak magnet to localize the device like a miniature satellite system.     This study will explore whether this system can be used in the future to more accurately     place the needle in or near the desired location or abnormality.      Patients 18 years of age and older who have a lesion that needs to be biopsied or an ablation     procedure that requires CT guidance may be eligible for this study. Candidates are screened     with a medical history and review of medical records, including imaging studies.      Participants undergo the biopsy or ablation procedure as they normally would, with the     following exceptions: some stickers are placed on the skin before the procedure and a very     weak magnet is placed nearby. The needles used are similar to the ones that would normally be     used except that they contain a metal coil or spring buried deep within the needle metal. The     procedure involves the following steps:        1. Small 1-cm plastic donuts are place on the skin with tape.        2. A planning CT scan is done.        3. The CT scan is sent to the computer and matched to the patient's body location with the          help of a very weak magnet.        4. The needle used for the procedure is placed towards the target tissue or abnormality and          the smart needle location lights up on the old CT scan.        5. A repeat CT is done as it normally is to look for the location of the needle.        6. After the procedure the CT scans are examined to determine how well the new tool located          the needle in the old scan.   "
172629|NCT00102739|"     This study is a double-blind, randomized, placebo-controlled, parallel group, repeat-dose,     study conducted in two parts (Part A and Part B) examining 30, 50, and 75 mg doses of     SB-497115-GR as a treatment for patients with ITP who have failed prior therapy. The study is     designed to determine the proportion of patients with a platelet count =50,000/µL after 42     days. In Part B, 99 newly-recruited subjects will be randomized to one of two dosing arms in     a 2:1 ratio of active:placebo. During the 6 week study period, subjects will start on placebo     or active drug (50 mg) and may have a dose increase to 75 mg based upon their platelet count     at day 22.   "
172615|NCT00102557|"     This study will compare two treatments for oral lichen planus - hydroxychloroquine     (Plaquenil) tablets and clobetasol oral rinse. Oral lichen planus is a chronic disorder in     which patients have painful mouth ulcers that interfere with meals and daily functioning. It     is most commonly treated with topical or systemic corticosteroids, but these drugs have a     number of side effects, most commonly yeast infection, and chronic systemic use of them can     lead to diabetes, osteoporosis, weight gain, and other complications. Also, lichen planus     generally returns when the corticosteroids are stopped. Clobetasol oral rinse is a topical     steroid commonly used to treat oral lichen planus. Hydroxychloroquine, a drug that was     originally used to treat malaria and is now also approved for lupus and rheumatoid arthritis,     has been tried for lichen planus in small-scale studies with some evidence of benefit.      Patients 18 years of age and older with oral lichen planus may be eligible for this study.     Pregnant women are excluded. Candidates are screened with a dermatology examination, routine     blood tests, an eye examination, and a biopsy to rule out other conditions similar to lichen     planus and to provide tissue for research purposes. For the biopsy, two small circles of     tissue about 4 mm (less than 1/5) across are surgically removed from the area with lichen     planus.      Participants are randomly assigned to treatment with either hydroxychloroquine or clobetasol     rinse. Patients assigned to hydroxychloroquine also take a placebo mouth rinse that looks and     tastes like the clobetasol rinse, and those assigned to clobetasol also take a pill that     looks and tastes like the hydroxychloroquine tablet. This is done so that neither the     patients nor the study doctors know which patient is taking which active medication until the     study is completed. Patients take the pills daily in the morning with food or a glass of milk     for the 6-month study period and use the rinse twice a day for 4 months and then once a day     for 2 months. They may not use any pain or anti-inflammatory medicines or topical creams,     gels or rinses regularly, because these medications can obscure the effects of the study     drugs and complicate interpretation of the results. They are given a topical numbing medicine     as part of the study and can use Tylenol for pain during the study duration.      In addition to treatment, participants visit the NIH Clinical Center once a month for the     following tests and procedures:        -  Review of pain levels, as recorded in a pain diary        -  Review of drug side effects, if any        -  Collection of saliva and blood samples at 2, 4 and 6 months        -  Repeat oral biopsy at completion of the study at 6 months to evaluate treatment effects        -  Final examination at 8 months to determine if the disease returns or improves after the          medication is stopped.   "
172616|NCT00102570|"     This study will evaluate children with allergies and collect medical data and biological     specimens from them periodically to learn more about the diseases and gain information that     may be useful in developing new treatments.      Patients 6 months to 18 years of age with a possible diagnosis of asthma, rhinitis,     anaphylaxis, hives, atopic dermatitis, food allergy, stinging insect allergy, and other     allergic and inflammatory diseases may be eligible for this study. Biological parents of     patients may also be enrolled to provide a blood sample for genetic studies.      Participants undergo tests appropriate for the diagnosis and management of their allergy.     They include the tests outlined below and, when necessary, additional blood tests, tissue     biopsies (surgical removal of a small piece of tissue for microscopic examination), computed     tomography (CT) or magnetic resonance imaging (MRI).        -  Pulmonary function test: This test evaluates lung function. The patient blows hard into          a tube attached to a machine to measure the airflow from the lungs. At home, the patient          uses a small plastic device called a peak flow meter to measure lung function. Patients          whose lung function measures less than 80 percent the value predicted for his or her age          may be given the medicine albuterol to see if lung function improves.        -  Skin prick testing: Drops of up to 55 different allergens (foreign substances, such as          pollen and certain foods or medicines that cause reactions like sneezing, hives, eczema,          and others) are placed on the back or arm. The skin under the allergen is then scratched          with a pointed tool. If the person is allergic, the skin around the scratch develops a          small area of itching, redness, or swelling that goes away after 30 to 60 minutes.        -  Acoustic rhinometry: To learn the effect of allergies on the size of the nasal cavity,          the nasal canal size is measured by placing a small round probe on the nostril. The          device sends out and receives a sound wave signal from which the size of the nasal canal          is calculated, recorded and stored graphically on a computer screen. The procedure is          repeated three times with each nostril.        -  Computerized assessment of learning and mood: Patients who are age 10 or older may take          this computer test to find out if allergies affect learning and mood. The test measures          the child's ability to understand directions, solve problems, and remember things. It          also includes questions about how the child feels in general.        -  Behavioral assessment system for children: Patients who are age 8 or older may take this          true/false questionnaire to assess mood.        -  Blood may be drawn for the following purposes: in lieu of skin prick testing to          determine sensitivity to allergens; to look for reasons for the severity or cause of an          allergy; for research studies on the immune system, including markers of allergy; for          genetic tests to determine inherited factors that increase the risk of developing          allergies.      Patients are scheduled for follow-up visits based on their diagnosis and severity of illness.     Most patients return for within one month of their first study visit and then, in general,     once a month when allergies are severe, and every few months when they are more stable.     Visits include an updated history and physical examination, blood tests, and possibly some of     the tests described above. Patients may also have intradermal skin testing, in which     allergens that are used for skin prick testing are injected into the forearms or upper arms     just below the surface of the skin.      Patients who test positive to allergens may be offered standard treatment with allergy shots.   "
172617|NCT00102583|"     Graft-vs.-Host Disease (GVHD) is a major complication of allogeneic hematopoietic stem cell     transplantation (SCT) commonly affecting the skin, liver, gastrointestinal tract, and eye.     The most common clinical manifestations of ocular GVHD generally result from      involvement of the lacrimal gland and the conjunctiva. Lacrimal gland involvement can lead to     aqueous tear deficiency resulting in severe keratoconjunctivitis sicca (KCS) which can     significantly increase the morbidity of patients with chronic GVHD.      Systemic immunosuppressants such as cyclosporine (CsA) can be effective for treating ocular     GVHD including lacrimal gland dysfunction. However, systemic immunosuppression is not     generally prescribed for patients whose sole manifestation of GVHD is ocular complications as     it may negate the overall graft-vs.-tumor effect and decrease patient survival. Topical CsA     and corticosteroids are generally not effective for treating aqueous tear deficiency possible     due to epithelial barriers preventing penetration of the drugs to the lacrimal gland. A     sustained-release subconjunctival CsA implant was developed to bypass these epithelial     barriers and significantly increase the CsA concentrations in the lacrimal gland to treat     aqueous tear deficiency related to GVHD.      The objective of this randomized pilot study is to investigate the safety and potential     efficacy of a CsA implant in patients with lacrimal gland involvement and aqueous tear     deficiency related to GVHD. Safety will be evaluated in terms of adverse events related to     the implant. Efficacy will be evaluated by changes in Schirmer tear test (with anesthesia).     Secondary efficacy evaluation will include changes in corneal and conjunctival staining     grades, best-corrected visual acuity (BCVA), the Ocular Surface Disease Index (OSDI), changes     in conjunctival GVHD grades, tear break-up time and meibomian gland dysfunction.      Patients with active systemic GVHD with aqueous tear deficiency associated with lacrimal     gland dysfunction following allogeneic hematopoietic SCT who are nine years of age or older     are eligible for inclusion in this pilot study. The study will involve surgical placement of     the CsA implant into the subconjunctival space adjacent to the lacrimal gland of one eye in     each participant. Participants older than 12 years of age will be randomized to receive one     of two implant release rates. All participants under the age of 12 will receive the smaller,     lower dose implant. However, all participants under age 12 will not be randomized and will     only be eligible to receive the smaller, lower dose implant.      The implant will remain in place for up to two years and then be removed. IF the participant     has clinical success, they will be given the option of allowing the implant to remain in     place for an additional year. Clinical success is achieved if the participant meets any of     the following measures in either eye assessed at the 1-year visit:      Interval change from baseline characteristics      Decrease in corneal staining by greater than or equal to 2      Decrease in temporal or nasal conjunctival staining grades by greater than or equal to 2      Decrease in total staining grade by greater than or equal to 2      Decrease in OSDI calculated score by greater than or equal to 20%      Increase in Schirmer tear test measurement by greater than or equal to 3 mm      Meets mild-moderate KCS characteristics at 1 year      Corneal staining grade less than or equal to 3      Nasal or temporal conjunctival staining grades less than or equal to 3      OSDI calculated score less than or equal to 15      Schirmer tear test measurement greater than or equal to 5 mm      For participants with implant duration of one year, safety evaluations will be conducted at     baseline (pre-implantation) and monthly post-implantation for 13 months. Additional safety     assessments will be done at 1 day, and at 1 and 2 weeks post-operatively for implant     placement and removal procedures. Safety and efficacy evaluations will be conducted at     baseline, at 1, 3, 6, 9, and 12 months post-implantation, and at 3 months following implant     removal (15 months post-implantation). For participants with clinical success and who choose     the implant to remain for another year, visits will be held as described above then conducted     at 2-month intervals starting at month 14. Safety evaluations will be conducted every 2     months until the end of the second year. Additional safety assessments will be done at 1 day,     and at 1 and 2 weeks post-operatively for implant removal procedures. Safety and efficacy     evaluations will be conducted at 16, 20, and 24 months post-implantation, and at 3 months     following implant removal (27 months post-implantation).   "
172732|NCT00094289|"     The purpose of this study is to assess potential interactions between intravenous cocaine and     ethanol and oral disulfiram.   "
172618|NCT00102596|"     OVERVIEW      Essential tremor (ET) is a common movement disorder affecting 0.4% of the general population     and up to 14% of people 65 years and older. Response to medications such as beta blockers and     primidone may be of benefit, but are often accompanied by intolerable side effects. Response     to ethanol, on the other hand, has a roughly 80% chance of significant tremor reduction,     though daily use of this as a treatment has potentially serious medical, social, and legal     consequences.      The leading hypothesis for ET pathophysiology is an unmasking of spontaneous oscillations     originating in neurons of the inferior olive. Both ethanol and 1-octanol have been shown to     reduce these spontaneous oscillations in an animal model of ET; however, 1-octanol does this     at a dose much lower than that leading to intoxication, suggesting in may be useful in the     treatment of essential tremor. Our initial studies with 1-octanol have shown it to be safe at     dosages up to 64mg/kg without signs of intoxication, while at the same time showing benefit.      OBJECTIVE      We plan to evaluate the efficacy of different 1-octanol formulations in humans based on     accelerometry and spirography. We will also evaluate drug and metabolite bioavailabilities     using a high performance liquid chromatography (HPLC) detection method from plasma and urine     samples.      STUDY POPULATION      We will study adult subjects with ethanol-responsive Essential Tremor (ET).      DESIGN      This study is designed as a two-phase unblinded inpatient study of adults with ET receiving     weight-adjusted oral dosages of 2 different formulations of 1-octanol in a crossover fashion.     Phase I of the study is designed to develop an octanol detection assay using HPLC. Four     subjects will receive daily escalating dosages (1-32 mg/kg) of a single 1-octanol formulation     followed by a crossover trial of both formulations at a dosage of 64 mg/kg. Phase II will     study 20 subjects receiving one of the two formulations at 64 mg/kg on inpatient day 1     followed by a 24 hour period of close monitoring. The second formulation will be given on day     3 and the patient will again undergo close monitoring for 24 hours.      OUTCOME MEASURES      The primary outcome measures for the study will be efficacy based on tremor ratings from     accelerometry and spirography. Secondary outcome measures will be the determination of     bioavailability, pharmacodynamic and pharmacokinetic profiles of octanol #61864 and octanol     #68751 and their metabolites.   "
172619|NCT00102609|"     The purpose of the study is to determine the dose of the combination of trabectedin     (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be     managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control     neutropenia) in patients with a type of cancer called soft tissue sarcoma.   "
172620|NCT00102622|"     The goal of this clinical research study is to find the highest safe dose of intraperitoneal     tgDCC-E1A that can be given in combination with paclitaxel as a treatment for patients with     recurrent, platinum-resistant ovarian cancer. How the cancer responds to this treatment will     also be studied. Researchers will also ask the patients if they will allow additional tumor     samples to be collected and extra blood samples to be drawn. These samples will be used to     learn about the biological response before and after treatment.   "
172621|NCT00102635|"     The primary objective of this study is to estimate the modulation of intermediate biological     endpoints of the combination of 4-HPR and SCH66336, a farnesyl transferase inhibitor (FTI),     across 4 randomly assigned dose levels in patients with locally advanced or recurrent head     and neck cancer. We will also assess the activity, safety, tolerability and side effects of     4-HPR/SCH66336 and hope to establish a phase II regimen.   "
172622|NCT00102648|"     The goal of this clinical research study is to find the highest safe dose of the new drug     Sarasar (lonafarnib) that can be given together with Temodar (temozolomide) in a continuous     daily dosing regimen to patients with brain tumors. The second goal is to learn if these     drugs given in combination can shrink or slow the growth of brain tumors.   "
172623|NCT00102661|"     The goal of this clinical research study is to learn if giving CAMPATH-1H first as an     injection into a vein, then as an injection under the skin can shrink or slow the growth of     the disease in patients with chronic lymphocytic leukemia (CLL) who have already received     standard therapy. Another goal is to learn if the side effects related to CAMPATH-1H     treatment are less severe by giving the drug first as an injection into a vein then as an     injection under the skin.   "
172624|NCT00102674|"     The purposes of this study are to:        -  Evaluate the tolerability of two cangrelor regimens.        -  Compare the PD of cangrelor regimens with oral clopidogrel.   "
172625|NCT00102687|"     The purpose of this study is to determine if azacitidine, combined with Best Supportive Care     (BSC), is effective in treating myelodysplastic syndromes (MDS) when given according to a     different doses and dosing schedules.   "
172626|NCT00102700|"     The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine     in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.   "
172627|NCT00102713|"     The purpose of the study is to assess the safety profile of the investigational medication,     Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.   "
172628|NCT00102726|"     SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet     counts in healthy volunteers. This study is examining several different doses of SB497115     versus placebo as treatment for patients with advanced solid tumors scheduled to receive     chemotherapy with carboplatin and paclitaxel every 21 days. Patients will receive SB497115 on     days 2-11 of each 21 day cycle for at least 2 cycles of chemotherapy and for a maximum of 8     cycles of chemotherapy.   "
172630|NCT00102752|"     The purpose of this study is to determine the safety of glufosfamide when administered in     combination with gemcitabine.   "
172631|NCT00102765|"     This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic     visits will include physical examination, medical history review and lung function tests. The     purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is     better in reducing the number of asthma exacerbations compared with another drug (fluticasone     propionate alone)   "
172632|NCT00102778|"     This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in     combination with Kaletra in HIV infected, untreated subjects.   "
172633|NCT00102791|"     The purpose of this study is to compare the effects of ICA-17043 to placebo with or without     hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle     cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to     a medical facility within the past 12 months.   "
172634|NCT00102804|"     This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best     supportive care versus placebo plus best supportive care in NSCLC. Participants must have     received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to     randomization (enrollment) into this trial.   "
172635|NCT00102817|"     This trial is conducted in the United States of America (USA). This is a 12 month study to     determine if Norditropin is safe and effective in children with IGF deficiency.   "
172636|NCT00102830|"     The purpose of this study is to test the safety, tolerability and pharmacokinetic (PK)     profile of AMG 386 after intravenous administration in adult subjects with advanced solid     tumors.   "
172640|NCT00102882|"     This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood     sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done     during the study. Study medicines and procedures will be provided at no cost. Patients will     be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR     and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and     older.   "
172641|NCT00102895|"     The main purpose of this research study is to see if the study drug, named CP-724,714, can     help in the treatment of certain breast cancers that have spread to other locations in the     body. Other goals of this study are to measure how long it may take for the cancer to get     worse (progress), to see if there are any side effects from the study drug, to check the     amount of study drug in the blood at different times, and to check to see if there is any     relationship between certain blood tests and how patients may respond to the study drug.      About 25 subjects at 4 sites (hospitals and clinics) in Bulgaria and Russia will be involved     in the trial. Participation in this study can last up to 48 weeks, depending on the     participant's toleration of the study drug and the response of her tumor(s) to the study     drug. All participants will receive CP-724,714, at a daily dose of 250 mg (4 pills) every 12     hours.   "
172642|NCT00102908|"     Bisphosphonates are a type of drug used to prevent and treat bone loss. The purpose of this     study is to determine if zoledronate, an investigational bisphosphonate, can improve bone     mineral density (BMD) in HIV-infected adults.      Study hypothesis: Zoledronate will reduce bone resorption in HIV-infected persons with     osteopenia.   "
172643|NCT00102921|"     The purpose of this research study is to investigate the effects of an investigational     medication, called CCX282-B, on safety and on the some of the symptoms of Crohn’s Disease in     patients who are experiencing an active flare-up of moderate to severe Crohn’s Disease.   "
172644|NCT00102934|"     Drug resistance may develop in HIV infected patients who take anti-HIV drugs, but most     patients do well if they continue taking them. The purpose of this study is to test the     effectiveness of a short, intensified course of anti-HIV drugs for controlling HIV infection     in adults who have virus resistant to multiple drugs.   "
172645|NCT00102947|"     This is a Phase 4, randomized, open-label, multicenter, comparative study designed to further     evaluate the pharmacokinetics of intravenous (i.v.) daptomycin and the safety and efficacy of     daptomycin relative to comparator in the treatment of complicated skin and skin structure     infections in patients with renal impairment.   "
172646|NCT00102960|"     The purpose of this study is to compare the effects of anti-HIV drug courses of different     lengths in infants who became HIV infected at birth.   "
172647|NCT00102973|"     The purpose of this research study is to determine if TLK286 given in combination with     carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent     ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is     refractory or resistant to platinum chemotherapy.   "
172648|NCT00102986|"     Men's and women's bodies may process anti-HIV drugs differently. The purpose of this study is     to determine the differences in blood levels of soft gel capsules and tablets of     lopinavir/ritonavir (LPV/r) in HIV infected men and women.   "
172655|NCT00103103|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with     fluorouracil and leucovorin works in treating patients with metastatic or unresectable     stomach cancer.   "
172656|NCT00103116|"     RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells may     make the body build an effective immune response to kill tumor cells.      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients     with stage I, stage II, or stage III non-small cell lung cancer.   "
174404|NCT00123903|"     This study was designed to determine whether COREG MR is more effective than TOPROL-XL in     reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood     pressure and microalbuminuria.   "
172649|NCT00102999|"     Objectives      The main objectives of this proposal are (1) to characterize motor learning abnormalities in     patients with focal dystonia; (2) to show, using transcranial magnetic stimulation, that this     abnormal motor learning went together with an impaired modulation by somatosensory inputs of     short and long-interval paired-pulse inhibitions (sICI, lICI) and facilitations (sICF, ICF)     of MEPs (ICIs and ICFs are thought to reflect activity of inhibitory and excitatory     interneuron's in the primary motor cortex M1); (3) to show that abnormalities of long-term     potentiation and long-term depression (LTP/LTD)-like mechanisms (tested using a paired     associative stimulation (PAS) intervention), thought to play a crucial role in learning, are     associated in dystonia with an abnormal modulation of ICIs and ICFs by somatosensory inputs.      Study population      30 patients with a focal upper limb dystonia and 45 healthy volunteers will take part in the     main study. 7 patients with a focal upper limb dystonia and 12 healthy volunteers will take     part in the control study.      Design      In the main study: subjects will complete 5 different sessions: visit 1: clinical screening,     1 hour; visit PAS session, 3 hours; visit 3: a minimum of 7 days later, motor learning     session, 3 hours; visit 4: follow-up 24 hours later, 1 hour and a half; visit 5, follow-up 48     hours later, 1 hour and a half. During the PAS session they will receive 15 minutes of     repeated paired stimulations (transcranial magnetic stimulation -TMS- and peripheral     stimulation) thought to produce LTP/LTD like phenomena in M1. During the motor learning     sessions they will be asked to perform, as fast as possible, a metronome-paced (0.5 Hz) pinch     of their index finger and thumb. They will have 3 blocks of motor practice during the motor     learning session.      Between each block of motor practice and before and after PAS, while they rest, subjects will     receive paired-pulse transcranial magnetic stimulations (TMS) associated or not with     peripheral nerve stimulation in order to assess interactions at M1 cortical level between     somatosensory incoming volleys and intracortical inhibitory and excitatory interneuron's.      In the control study: subjects will complete a unique session. They will receive a PAS     intervention. Before and after the PAS intervention, spinal excitability will be tested by     the means of H reflexes evoked in wrist flexor muscles.      Outcome measures:      The behavioral effect of the motor training or of the PAS intervention will be assessed by     measuring the mean peak acceleration (MPA) of thumb movement during the blocks of motor     practice and the mean maximal peak force (MPF) between the index finger and thumb before and     after the blocks of motor practice.      The activity of different sets of intracortical interneurons (short and long interval GABA     related inhibitions: sICI, lICI, intracortical glutamate-related facilitation: ICF and short     interval facilitation: sICF) can be tested using paired-pulse TMS paradigms. The effect of     learning (or of PAS intervention) on the interaction between somatosensory afferent input and     intracortical processes will be assessed by comparing the amount of sICI, lICI, ICF and sICF     when associated or not with a peripheral nerve stimulation (median and ulnar nerve     stimulation) in a trained muscle (flexor pollicis brevis: FPB) and a non-trained muscle     (abductor digiti minimi: ADM) at different times during and after the motor learning or the     PAS intervention.      The effect of PAS on spinal cord excitability will be assessed by comparing the size of the H     reflex before and after PAS.   "
172661|NCT00093262|"     The purpose of this study is to establish the efficacy of of clevidipine versus placebo in     treating postoperative hypertension. Approximately 100 patients with postoperative     hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery     bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or     valve replacement/repair procedures were anticipated to be randomly assigned to one of two     treatment groups: clevidipine or placebo.   "
172650|NCT00103012|"     This study will examine the interaction of the HIV combination medication lopinavir/ritonavir     with the herbal products echinacea, ginseng, and ginkgo biloba. Patients with HIV infection     often take herbal products and dietary supplements in addition to their doctor-prescribed     medicines to treat the disease, lessen the side effects of anti-viral drugs, and improve     their overall well being. Alternative medicines such as these may, however, interfere with     the elimination of lopinavir/ritonavir from the body, causing either higher or lower blood     levels of these drugs than would be expected. This study will assess in healthy subjects any     potential harms of taking echinacea, ginseng, or ginkgo biloba together with     lopinavir/ritonavir.      Healthy normal volunteers between 18 and 50 years of age may be eligible for this study.     Candidates are screened with a history, physical examination, and blood tests, including an     HIV test and a pregnancy test for women. Pregnant women are excluded from the study.     Participants come to the NIH Clinical Center after fasting overnight for the following     procedures:      Visits 1 and 2: A catheter (plastic tube) is placed in an arm vein to collect blood samples.     After the first sample is drawn, the subject takes 8 mg of midazolam syrup and two     fexofenadine tablets. Midazolam is a sedative, and fexofenadine (Allegra) is a medicine used     to treat allergies. Subjects are given breakfast an hour after taking the drugs. Blood     samples are collected at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 24 hours after taking     the drugs to measure blood levels of fexofenadine. An extra sample is collected at the 4-hour     mark to measure the midazolam level. The catheter is removed after the 8-hour blood draw and     subjects are dismissed home. They return the following morning (visit 2) for the 24-hour     blood draw.      Visit 3: From 7 to 28 days after visit 1, subjects begin taking lopinavir/ritonavir capsules     twice a day by mouth for a total of 29.5 days. On day 15 they return to the clinic for     lopinavir/ritonavir blood levels as were done for fexofenadine, except that samples are     collected once before breakfast and then at 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after the     lopinavir/ritonavir dose. An extra sample is collected for routine tests. The catheter is     removed after the 12-hour draw and the subject is dismissed home.      The next morning, subjects begin taking one of the following: echinacea 500 mg 3 times a day;     ginkgo biloba 120 mg twice a day; or ginseng 500 mg 3 times a day for 28 days.      Visit 4: On the last day of taking lopinavir/ritonavir, subjects return to the clinic again     for blood level measurements of these drugs as on visit 3, except that the catheter is     removed and the subject dismissed home after the 8-hour blood draw.      Visits 5 and 6: On the last day of taking the herbal supplement, subjects return to the     clinic for repeat measurement of fexofenadine and midazolam levels, as described in visits 1     and 2. At the final visit (visit 6) an additional blood sample is collected for repeat     laboratory testing.   "
172651|NCT00103025|"     This study will determine the dose of sodium nitrite that can safely be used to prevent     constriction, or tightening, of the arteries. Narrowed arteries in the brain can cause     stroke. Animal studies show that nitrite injections improve blood flow and that injections     over long periods of time prevent damage to the arteries in the brain; however, there is no     information on the effects of prolonged nitrite infusion in humans. This study will establish     the safe dose and side effects of nitrite infusion in humans.      Healthy normal volunteers between 21 and 60 years of age may be eligible for this study.     Candidates are screened for high or low blood pressure, aspirin use, pregnancy, and blood     levels of nitrite and methemoglobin (a substance that temporarily and slightly lowers the     oxygen carried in the red blood cells). Pregnant women are excluded from the study.      Participants are admitted to the Clinical Center for 16 1/4 days, the first 2 days in the     hospital's intensive care unit (ICU). Upon admission they provide a medical history, have     physical and cardiovascular examinations, and blood tests. For the infusion procedure, a     catheter (thin plastic tube) is inserted into an artery in the wrist or the crease of the     elbow to measure blood pressure, and catheters are placed in a vein in each arm for     administering the nitrite and withdrawing blood samples.      In the morning of day 1, after initial blood pressure and heart rate measurements are taken     and a blood sample is drawn, a saline (salt water) infusion is started. Blood pressure and     heart rate are monitored every 30 minutes for 6 hours, then every hour for 6 hours, then     every 2 hours for 12 hours. Blood samples are collected every 4 hours for 24 hours. On day 2,     the sodium nitrite infusion begins. Blood pressure and methemoglobin are monitored every 10     minutes for the first 2 hours. If blood pressure remains stable, the frequency of     measurements is decreased to every 30 minutes for 4 hours, then every 1 hour for the next 6     hours, and then every 4 hours for 12 hours. If the pressure continues to remain stable,     monitoring continues every 8 hours for the rest of the study. Blood is drawn periodically     from the catheter to determine the amount of nitrite and methemoglobin in the body, with     decreasing frequency from several times during the first hour of the infusion to every 24     hours. After the first 24 to 48 hours of the nitrite infusion, participants are transferred     from the ICU to a general nursing unit fo...   "
172652|NCT00103038|"     This clinical trial studies magnetic resonance imaging (MRI) using a contrast imaging agent     ferumoxytol (ferumoxytol non-stoichiometric magnetite) in improving viewing tumors in     patients with high-grade brain tumors or cancer that has spread to the brain. Diagnostic     procedures, such as MRI, may help find and diagnose brain tumors and find out how far the     disease has spread. The contrast imaging agent ferumoxytol non-stoichiometric magnetite     consists of small iron particles taken by the blood stream to the brain and to the area of     the tumor. It may help visualize the blood flow going through the tumor better than the     standard substance gadolinium-based contrast agent.   "
172653|NCT00103051|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Giving gemcitabine and cisplatin together with gefitinib before surgery may     shrink the tumor so it can be removed.      PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together     with gefitinib works in treating patients who are undergoing surgery for stage III non-small     cell lung cancer.   "
172654|NCT00103090|"     RATIONALE: Drugs, such as fenretinide and lonafarnib, may stop the growth of head and neck     cancer by blocking blood flow to the tumor. Fenretinide may also help tumor cells become     normal cells. Lonafarnib may also stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Giving fenretinide together with lonafarnib may kill more     tumor cells.      PURPOSE: This randomized phase I trial is studying the side effects and best dose of     fenretinide and lonafarnib in treating patients with advanced or recurrent head and neck     cancer.   "
172703|NCT00093899|"     The purpose of this study is to assess the cholesterol lowering effects of an investigational     drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).   "
174421|NCT00117247|"     The purpose of this study is to evaluate the single dose pharmacokinetics (PK) of     subcutaneous (SC) darbepoetin alfa in subjects with congestive heart failure (CHF) and     anemia.   "
172657|NCT00103142|"     RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make     the body build an effective immune response to kill tumor cells. Biological therapies, such     as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system     in different ways and stop tumor cells from growing. Combining different types of biological     therapies may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying giving vaccine therapy together with     dendritic cells to see how well it works compared to giving vaccine therapy together with     GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by     surgery.   "
172658|NCT00103155|"     RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor     cells. Ultrasound-guided radiofrequency ablation may be effective treatment for thyroid     cancer.      PURPOSE: This phase I trial is studying the side effects of radiofrequency ablation in     treating patients who are undergoing surgery for thyroid cancer.   "
172659|NCT00103168|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining     tumor cells. It is not yet known whether imatinib mesylate is more effective than observation     only in treating gastrointestinal stromal tumor.      PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it     works compared to observation only in treating patients who have undergone surgery for     localized gastrointestinal stromal tumor.   "
172667|NCT00093353|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different     ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help     irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be     effective in preventing diarrhea that is caused by treatment with irinotecan.      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when     given together with temozolomide and cefixime in treating young patients with recurrent or     resistant neuroblastoma.   "
172668|NCT00093366|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to     stop cancer cells from dividing so they stop growing or die. Biological therapies such as     etanercept may interfere with the growth of the cancer cells. Combining chemotherapy with     biological therapy may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects of giving arsenic trioxide     together with etanercept and to see how well it works in treating patients with     myelodysplastic syndromes.   "
172669|NCT00093379|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop tumor cells from dividing so they stop growing or die. Capecitabine     may stop the growth of tumor cells by stopping blood flow to the tumor. Radiation therapy     uses high-energy x-rays to damage tumor cells. Capecitabine and oxaliplatin may make tumor     cells more sensitive to radiation therapy. Combining capecitabine and oxaliplatin with     radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin     together with radiation therapy works in treating patients with stage II or stage III anal     cancer.   "
172670|NCT00093405|"     RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work     in different ways to stop tumor cells from dividing so they stop growing or die.     17-N-allylamino-17-demethoxygeldanamycin may also stop the growth of tumor cells by blocking     the enzymes necessary for their growth.      PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin     works in treating patients with metastatic kidney cancer.   "
172671|NCT00093418|"     This randomized phase II trial is studying 4 different tipifarnib regimens to compare how     well they work in treating older patients with acute myeloid leukemia. Tipifarnib may stop     the growth of cancer cells by blocking the enzymes necessary for their growth   "
172672|NCT00093444|"     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways     to stop tumor cells from dividing so they stop growing or die. Radiofrequency ablation uses     high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with     liposomal doxorubicin may increase the effectiveness of the drug and kill more tumor cells.      PURPOSE: This phase I trial is studying the best dose of liposomal doxorubicin when given     with radiofrequency ablation in treating patients with primary or metastatic liver tumors.   "
172673|NCT00093457|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth.      PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients     who have metastatic or recurrent prostate cancer that has not responded to previous hormone     therapy.   "
172674|NCT00093470|"     This randomized phase III trial studies tipifarnib in treating patients with acute myeloid     leukemia (AML) in remission. Tipifarnib may stop the growth of cancer cells by blocking the     enzymes necessary for their growth. It is not yet known whether tipifarnib is more effective     than observation alone in preventing the recurrence of AML.   "
172675|NCT00093483|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, cytarabine, and idarubicin,     work in different ways to stop cancer cells from dividing so they stop growing or die.     Combining more than one drug may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide     when given together with cytarabine and idarubicin in treating patients with acute myeloid     leukemia.   "
172676|NCT00093496|"     Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in     treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity     cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work     in different ways to stop tumor cells from dividing so they stop growing or die.   "
172677|NCT00093509|"     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above     body temperature. Using MRI to measure heat may help to determine the effectiveness of     hyperthermia therapy. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs     used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop     tumor cells from dividing so they stop growing or die. Combining hyperthermia with radiation     therapy and chemotherapy before surgery may kill more tumor cells and shrink the tumor so     that it can be removed.      PURPOSE: This phase I/II trial is studying the side effects of hyperthermia when given     together with radiation therapy and optional chemotherapy and to see how well they work in     treating patients who are undergoing surgery for soft tissue sarcoma of the limbs.   "
172678|NCT00093522|"     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body     build an immune response to kill tumor cells. Drugs used in chemotherapy, such as     fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or     die. Combining vaccine therapy with fludarabine may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying vaccine therapy and fludarabine to see     how well they work compared to vaccine therapy alone in treating patients with stage IV     kidney cancer.   "
172679|NCT00093548|"     RATIONALE: Vaccines made from DNA and a gene-modified virus may make the body build an immune     response to kill tumor cells. Giving booster vaccinations may make a stronger immune response     and prevent or delay the recurrence of liver cancer.      PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy     and to see how well it works in treating patients with stage II, stage IIIA, stage IIIB, or     stage IVA liver cancer.   "
172680|NCT00093561|"     RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the     development or recurrence of cancer. The dietary supplement lycopene may prevent the     development of prostate cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in     preventing prostate cancer in healthy participants.   "
172746|NCT00094484|"     The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with     placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).   "
172681|NCT00093587|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow     transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It     also helps stop the patient's immune system from rejecting the donor's stem cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving antithymocyte globulin before transplant and cyclosporine after transplant may stop     this from happening.      PURPOSE: This randomized clinical trial is studying how well giving antithymocyte globulin     together with cyclosporine works in preventing graft-versus-host disease in patients who are     undergoing chemotherapy with or without radiation therapy followed by donor stem cell     transplant for acute lymphoblastic leukemia or acute myeloid leukemia.   "
172682|NCT00093600|"     RATIONALE: PKC412 may stop the growth of cancer cells by blocking the enzymes necessary for     their growth. It may also increase the effectiveness of daunorubicin and cytarabine by making     cancer cells more sensitive to the drugs. Drugs used in chemotherapy, such as daunorubicin     and cytarabine, work in different ways to stop cancer cells from dividing so they stop     growing or die. Combining PKC412 with chemotherapy may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best way to give PKC412 when     given either after or together with daunorubicin and cytarabine in treating patients with     newly diagnosed acute myeloid leukemia.   "
172683|NCT00093613|"     This phase I trial is studying the side effects and best dose of sorafenib in treating     patients with recurrent or progressive malignant glioma. Sorafenib may stop the growth of     tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for     their growth.   "
172684|NCT00093626|"     Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by     blocking the enzymes necessary for their growth. This phase II trial is studying how well     sorafenib works in treating patients with persistent or recurrent ovarian epithelial or     peritoneal cancer.   "
172685|NCT00093639|"     RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop     cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth     of cancer cells by blocking the enzymes necessary for their growth. Combining everolimus with     imatinib mesylate may be effective in killing cancer cells that have become resistant to     imatinib mesylate.      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when     given together with imatinib mesylate and to see how well they work in treating patients with     chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission     after previous imatinib mesylate.   "
172686|NCT00093652|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop     tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor     cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy     x-rays to damage tumor cells. Combining oxaliplatin and gefitinib with radiation therapy may     kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin when     given together with gefitinib and radiation therapy and to see how well they work in treating     patients with locally advanced or metastatic esophageal cancer.   "
172764|NCT00094731|"     The purpose of this study is to determine whether classes on memory training will help older     adults to improve or maintain their daily activities.   "
172687|NCT00093665|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different     ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses     high-energy x-rays to damage tumor cells. Combining fluorouracil and cisplatin with radiation     therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving fluorouracil and cisplatin together     with radiation therapy works in treating patients with stage II, stage III, or stage IV     nasopharyngeal cancer.   "
172688|NCT00093678|"     RATIONALE: Celecoxib may help relieve moderate or severe pain associated with cancer. It may     also decrease weight loss and improve muscle strength in cancer patients.      PURPOSE: This randomized clinical trial is studying celecoxib to see how well it works in     managing pain, weight loss, and weakness in patients with advanced cancer.   "
172689|NCT00093704|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary     for their growth. The Epstein Barr virus can cause cancer and lymphoproliferative disorders.     Ganciclovir is an antiviral drug that acts against the Epstein Barr virus. Giving ganciclovir     together with bortezomib may kill more Epstein Barr virus-infected cancer cells.      PURPOSE: This clinical trial is studying how well giving bortezomib together with ganciclovir     works in treating patients with relapsed or refractory Epstein Barr virus-positive lymphoma.   "
172690|NCT00093730|"     RATIONALE: BMS-599626 may stop the growth of tumor cells by blocking the enzymes necessary     for their growth.      PURPOSE: This phase I trial is studying the side effects and best dose of BMS-599626 in     treating patients with metastatic solid tumors.   "
172691|NCT00093743|"     Based on success in other diseases, the Fred Hutchinson Cancer Research Center (FHCRC) has     developed a transplant procedure for Fanconi anemia (FA), which does not completely destroy     the patient's remaining bone marrow. It should also be less harmful (toxic). Researchers wish     to test whether this approach can overcome the graft failure often seen when bone marrow or     peripheral blood stem cells from an unrelated donor are used. Researchers also will look at     whether the procedure is less toxic than a conventional bone marrow transplant (BMT).   "
172692|NCT00093756|"     This phase I/II trial (phase I closed to accrual as of 09/29/2009) is studying the side     effects and best dose of bortezomib, paclitaxel, and carboplatin when given with radiation     therapy and to see how well they work in treating patients with stage IIIA or stage IIIB     non-small cell lung cancer that cannot be removed by surgery. Bortezomib may stop the growth     of tumor cells by blocking the enzymes necessary for their growth. Drugs used in     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells     from dividing so they stop growing or die. Bortezomib may increase the effectiveness of     paclitaxel and carboplatin by making tumor cells more sensitive to the drugs. Radiation     therapy uses high-energy x-rays to damage tumor cells. Giving bortezomib, paclitaxel, and     carboplatin together with radiation therapy may kill more tumor cells.   "
172693|NCT00093769|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary     for their growth. Monoclonal antibodies such as rituximab can locate cancer cells and either     kill them or deliver tumor-killing substances to them without harming normal cells. Giving     bortezomib together with rituximab may kill more cancer cells.      PURPOSE: This randomized phase II trial is studying how well giving bortezomib together with     rituximab works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.   "
172694|NCT00093782|"     This phase II trial is studying how well CCI-779 works in treating patients with progressive     metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as CCI-779, work in     different ways to stop tumor cells from dividing so they stop growing or die.   "
172695|NCT00093795|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin , cyclophosphamide,     paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they     stop growing or die. Giving combination chemotherapy after surgery may kill any remaining     tumor cells.      PURPOSE: This randomized phase III trial is studying three different combination chemotherapy     regimens and comparing how well they work in treating women who have undergone surgery for     node-positive breast cancer.   "
172696|NCT00093808|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and vinorelbine, work in     different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal     antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor     killing substances to them without harming normal cells. Giving capecitabine and vinorelbine     together with trastuzumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving capecitabine and vinorelbine     together with trastuzumab works in treating patients who have metastatic breast cancer.   "
172697|NCT00093821|"     This phase I trial is studying the side effects and best dose of tanespimycin in treating     young patients with recurrent or refractory leukemia or selected solid tumors. Drugs used in     chemotherapy, such as tanespimycin, work in different ways to stop cancer cells from dividing     so they stop growing or die.   "
172698|NCT00093834|"     RATIONALE: Vaccines made from a person's tumor cells may make the body build an immune     response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and     doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or     die. Combining vaccine therapy with cyclophosphamide and doxorubicin may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide     and doxorubicin when given with vaccine therapy in treating women with stage IV breast     cancer.   "
172699|NCT00093847|"     This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant     drug treatment in reducing depressive symptoms in depressed people who have not responded to     antidepressants alone.   "
172700|NCT00093860|"     This study will examine the effectiveness of the drug propranolol in preventing fainting in     patients with sympathoadrenal imbalance (SAI). SAI is a particular pattern of nervous system     and chemical responses in which the blood vessels in skeletal muscles do not remain     constricted appropriately during standing for a long time. This can lower blood pressure and     cause fainting. Propranolol (Inderal® (Registered Trademark)) is a Food and Drug     Administration-approved drug that belongs to a class of drugs called beta-blockers. These     drugs slow the heart rate and maintain blood pressure in certain situations.      Children between 10 and 17 years of age with frequent fainting or near-fainting due to SAI     may be eligible for this study. Children must experience severe dizzy episodes at least once     every 2 months or fainting episodes at least once every 4 months. The condition must be     severe enough to affect the child's quality of life or to have forced the child to alter his     or her life routines to accommodate to the illness. Screening includes a tilt table test,     described below, to determine if the child has a particular chemical pattern in the blood.      Children enrolled in the study take propranolol pills in increasing doses during the first     week of the study to determine the proper dose for the individual. Then, the drug is stopped     until the experimental phase of the study begins. In this phase, children are randomly     assigned to take either propranolol or placebo (a look-alike pill with no active ingredient)     for a maximum of 3 days. On the fourth day, the child undergoes a tilt table test to     determine whether the treatment affects his or her ability to tolerate tilt. For this test,     the child lies on a padded table with a motorized tilt mechanism that can move the child from     a flat position to an upright position in about 10 seconds. The child remains upright for up     to 40 minutes while the following measurements are taken:        -  Blood sampling: Blood is drawn through a catheter (thin plastic tube) placed in an arm          vein. This allows repeated sampling without repeated needle sticks. Samples are          collected before starting the tilt test, about every 4 minutes during the test,          immediately when a drop in blood pressure is detected or symptoms develop, and after 10          minutes of recovery lying flat. A maximum of 12 samples are collected for each tilt          test.        -  Physiologic measurements: Blood pressure, heart rate, and electrocardiogram (EKG) are          measured continuously during the tilt test session, and blood flows and skin electrical          conduction are measured intermittently. Blood flow is measured using sensors applied to          the skin and a blood pressure cuff around the limb. For skin blood flow measurements, a          laser beam scans the skin surface. The skin electrical conduction test measures how well          the skin conducts electricity. This is measured through sensors placed on the tips of          two fingers. Respiration and breathing rate are monitored by an elastic cloth band          around the chest.        -  Self-report questionnaires: Patients or their parents complete a questionnaire about the          child's symptoms before and during treatment.      The effects of the test drug are allowed to wear off for up to 1 week, after which the entire     tilt test procedure is repeated. Patients who were given propranolol for the first test     session take placebo for the repeat session, and those who were given placebo take     propranolol.   "
172701|NCT00093873|"     This study will determine the safety and pharmacokinetics of AMG 706 in subjects with     advanced solid tumors.   "
172702|NCT00093886|"     The purpose of this study is to establish the safety of clevidipine in the treatment of     perioperative hypertension. Approximately 500-900 patients with perioperative hypertension     undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or     minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve     replacement/repair procedures were anticipated to be randomly assigned to one of two     treatment groups: clevidipine or nitroglycerin.   "
172777|NCT00094900|"     Autoinflammatory diseases are illnesses characterized by episodes of inflammation that,     unlike autoimmune disorders, lack the production of high titer autoantibodies or     antigen-specific T cells. There is growing genetic and clinical evidence that Interleukin-1     (IL-1) plays a pathogenic role in several of these diseases. This exploratory study aims to     examine the utility of the experimental drug candidate, IL 1 Trap (Regeneron Pharmaceuticals,     Inc.) in the treatment of adult subjects with the autoinflammatory disorders Neonatal Onset     Multisystem Inflammatory Disease (NOMID), Muckle-Wells Syndrome (MWS), and Familial Cold     Autoinflammatory Syndrome (FCAS), Familial Mediterranean Fever (FMF), and adult Still's     disease. FMF is associated with mutations in pyrin encoding MEFV. NOMID, MWS and FCAS are     associated with mutations in cryopyrin-encoding CIAS1.      This pilot study is designed to address: 1) the utility of IL 1 Trap in the treatment of     subjects with diseases known to respond to IL-1 blockade (NOMID/MWS/FCAS) as shown by     response to treatment with anakinra [Kineret]; 2) the response to IL-1 blockade of subjects     with Adult Still's disease and colchicine-resistant FMF once the efficacy of IL-1 Trap has     been established in NOMID/MWS/FCAS subjects; and 3) the biochemistry and genetics of     autoinflammatory diseases and IL-1 related inflammation.      IL-1 Trap is a recombinant fusion protein with picomolar affinity for IL-1 and a half-life of     approximately 7.5 days in humans. This agent is currently in Phase 2 clinical studies for the     treatment of rheumatoid arthritis and initial studies have shown activity against clinical     and biochemical indicators of inflammation. Compared with anakinra, this agent may exhibit     improved dosing convenience, potential for fewer injection site reactions, and improved     efficacy due to the extremely high affinity of IL-1Trap for its target.      In this study, biochemical, genetic, and clinical correlates of autoinflammatory disease will     initially be measured at baseline following a withdrawal of any TNF or IL-1 inhibitor     medications where applicable. Subjects will receive a course of therapy with IL-1 Trap that     is predicted to provide an estimated 3-4 weeks of anti-inflammatory activity. Clinical,     biochemical, and genetic correlates of inflammation will be measured at appropriate intervals     to ascertain response and to further elucidate disease mechanisms. Subjects will be eligible,     based on clinical response, to enter a 1- year extension phase with IL-1 Trap. Those subjects     who complete the 1-year extension phase, and maintain improved clinical and laboratory     parameters compared to baseline values, may continue to receive study medication at their     current dose until the study drug is commercially available.      Investigator comment:      This protocol (from the NIH standpoint) is a continuation of the ongoing protocol 05-AR-0014,     with a new change in study sponsor, the NIH replacing Regeneron as sponsor. this protocol     therefore still contains background and procedural information that refer to patients with     FMF and FCAS and or MWS and Still's disease, however only patients with Still's disease will     be newly enrolled from this point on, enrollment for the FCAS and or MWS patients has already     been completed and it has been decided to not enroll any more FMF patients because the number     of subjects is too low to reach reasonable conclusions, in addition it has been difficult to     recruit patients that are eligible. The background section and study procedures have largely     been left as in the currently IRB approved protocol.   "
172704|NCT00093912|"     The purpose of this study is to establish the safety of clevidipine in the treatment of     perioperative hypertension. Approximately 250-500 patients with perioperative hypertension     undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or     minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve     replacement/repair procedures were anticipated to be randomly assigned to one of two     treatment groups: clevidipine or sodium nitroprusside.   "
172705|NCT00093925|"     The purpose of this study is to establish the safety of clevidipine in the treatment of     postoperative hypertension. Approximately 250-500 patients with postoperative hypertension     after undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass     (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve     replacement/repair procedures were anticipated to be randomly assigned to one of two     treatment groups: clevidipine or nicardipine.   "
172706|NCT00093938|"     The purpose of this study is to determine the amount of cranberry juice that is most     effective in preventing a condition in pregnant women that often leads to urinary tract     infections (UTIs).   "
172707|NCT00093951|"     The purpose of this trial is to determine the effect of a new drug, SGS742, on memory and     cognition in patients with mild to moderate Alzheimer's disease.   "
172708|NCT00093964|"     This study will investigate clinical activity, safety, and tolerability of the     anti-angiogenic compound cilengitide (EMD 121974) in the treatment of first recurrence of     glioblastoma multiforme (GBM).   "
172709|NCT00093977|"     The purpose of this study is to determine whether darbepoetin alfa manufactured by the     current roller bottle technology and darbepoetin alfa manufactured by a serum free process     have a comparable safety profile.   "
172710|NCT00093990|"     The purpose of this study is to determine the effectiveness of tipifarnib in patients aged 70     or more with acute myeloid leukemia. Tipifarnib belongs to a class of drugs called Farnesyl     Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.   "
172711|NCT00094003|"     This study is to investigate the safety of NS-9 and to see how well it is tolerated in     patients with cancer that has metastasized (spread) to the liver from another primary tumor.     NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells.     This study is also set up to determine the best dose to use.   "
172712|NCT00094016|"     The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcg/day and     QVAR-Easi-Breathe 200 mcg/day with placebo relative to changes in forced expiratory volume in     1 second (FEV1) results following 12 weeks of treatment. Secondary objectives such as daily     asthma symptoms scores (per week), morning peak expiratory flow (PEF) values, nocturnal     awakening and utilization of rescue medication per day also will be evaluated. In addition,     an exploratory evaluation will assess the comparability of the two devices (i.e.,     QVAR-Easi-Breathe versus QVAR-MDI) at the same dose levels.   "
172713|NCT00094029|"     The purpose of this study is to permit access to SU011248 for treatment use by patients with     GIST given the following conditions: a) patients undergo screening, but are not eligible for     participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which     standard treatments have not been able to control with acceptable toxicity AND c) patients     have the potential to derive clinical benefit from treatment with SU011248.   "
172714|NCT00094042|"     This project seeks to understand how changes in the health of an individual affects the     economic and social prosperity of the individual, family and community. The study involves     providing iron supplements to a sample of participants in Central Java Indonesia and     following those respondents for three years. They are compared with a control group who do     not receive the supplement.   "
172715|NCT00094055|"     This is a Phase 2 study being conducted at multiple centers in the United States. Patients     having thyroid cancer that has spread to other parts of the body (i.e., metastatic) are     eligible to participate. Patients must have disease that was not controlled by previous     treatment with radioactive iodine (131I) or not be good candidates for such treatment. The     purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective     treatment for metastatic thyroid cancer as shown by the number of patients in the study who     experience significant and durable tumor shrinkage.   "
172716|NCT00094068|"     This study will determine whether sildenafil citrate, commonly known as Viagra, can cause     increased blood flow to the brain in a wide range of multiple sclerosis (MS) patients,     including women. Although people with MS can have reduced blood flow in the brain as part of     the disease process, it has been observed that men with MS may have increased blood flow to     the brain while taking sildenafil citrate. This study will measure brain blood flow or blood     volume in men and women with MS before and after taking Viagra and compare the results to     those in healthy volunteers in an effort to better understand the disease.      Healthy volunteers 18 years of age and older and patients with MS between 18 and 55 years of     age may be eligible for this study. Volunteers are screened with a medical history and     physical examination, and patients with MS are evaluated with a complete neurological     examination and screening for heart disease, including history of chest pain, heart attack,     and use of nitrates.      Participants undergo magnetic resonance imaging (MRI) before and after taking Viagra. During     the scanning, subjects lie still on a table that can slide in and out of the cylindrical     metal scanner. Scanning time varies from 20 minutes to 3 hours, with most scans lasting     between 45 and 90 minutes. First, a scan is obtained of the carotid arteries (major arteries     in the neck supplying blood to the brain) to determine if the arteries are narrowed, and then     baseline MRI scans and measures of brain blood flow are obtained. The subject then comes out     of the scanner and takes a Viagra pill. After 1 hour, the subject returns to the scanner and     more scans are obtained to determine changes in brain blood flow and blood volume following     Viagra.      A catheter (thin plastic tube) is placed in the subject's arm before he or she enters the     magnet for the second time for injection of a contrast agent called gadolinium DTPA, which     allows brain structures to be distinguished more clearly.   "
172717|NCT00094081|"     The trial will compare the efficacy and safety of concomitant chemoradiation with     tirapazamine, cisplatin and radiation versus cisplatin and radiation.   "
172718|NCT00094094|"     This is a Phase 2 study being conducted at multiple centers in the United States and Germany.     Patients having non-small cell lung cancer that has spread to other parts of the body (i.e.,     metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are     eligible to participate. Patients must have disease that has been treated with at least 1     prior treatment for metastatic disease (prior adjuvant treatment for localized disease does     not count as prior treatment for metastatic disease). The purpose of the study is to test     whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small     cell lung cancer as shown by the number of patients in the study who experience significant     and durable tumor shrinkage   "
172778|NCT00094913|"     The purpose of this study is to identify the earliest predictors of memory and brain     deterioration in pre-clinical Alzheimer's disease using positron emission tomography (PET) to     monitor brain glucose metabolism.   "
172719|NCT00094107|"     This is a Phase 2 study being conducted at multiple centers in the United States and France.     Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are     eligible to participate. Patients must have disease that has been treated with no more than 1     prior treatment for metastatic disease (prior adjuvant treatment for localized disease does     not count as prior treatment for metastatic disease). The purpose of the study is to test     whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic     melanoma as shown by the number of patients in the study who experience significant and     durable tumor shrinkage.   "
172720|NCT00094120|"     Age-Related Macular Degeneration (AMD) is a degenerative disease of the retina that causes a     progressive loss of central vision. AMD is the leading cause of legal blindness among adults     age 50 or older in the Western world. AMD presents in two different types - dry and the     more severe wet form. Wet AMD is caused by the growth of abnormal blood vessels in the     macula.      Squalamine lactate is an investigational drug that may prevent the growth of these abnormal     blood vessels. This study will test the safety and efficacy of Squalamine when administered     with verteporfin therapy in patients with wet AMD.   "
172721|NCT00094133|"     RATIONALE: Hypnosis may be effective in decreasing hot flashes in breast cancer survivors.      PURPOSE: This randomized clinical trial is studying how well hypnosis works in treating hot     flashes in breast cancer survivors.   "
172722|NCT00094146|"     This study is in patients with at least moderate obesity (Body Mass Index [BMI] > 30 kg/m2 or     approximately 30 or more pounds overweight) and who also produce too much insulin (insulin     stores sugar as fat). Sandostatin LAR® Depot suppresses insulin, and is being developed to     help with weight loss in people who find it hard to lose weight on their own because they     produce too much insulin.      The main purpose of the study is to find the lowest dose of Sandostatin LAR® Depot that     safely helps overweight people lose weight. The study will also compare weight loss in obese     patients who receive one of three different dosages of Sandostatin LAR Depot or placebo.   "
172723|NCT00094159|"     The purpose of this study is to determine whether SNS-595 given intravenously weekly for 3     weeks is safe.   "
172724|NCT00094172|"     Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop     problems related to the central nervous system, which controls the nerves in the body. Some     of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease     of the nervous system. The purpose of this study is to determine if the drug atorvastatin is     helpful to CIS patients.      Study hypothesis: Early intervention with atorvastatin in patients with CIS will result in a     state of immunological tolerance.   "
172725|NCT00094185|"     To identify genetic variants in 12 key blood clotting proteins that may modify the risk of     venous thromboembolism in users of hormone replacement therapy.   "
172733|NCT00094302|"     The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy     in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure     hospitalization in patients who have heart failure with preserved systolic function.   "
172734|NCT00094315|"     To study of classical conditioning mechanisms associated with arousal, craving and cocaine     use.   "
172735|NCT00094328|"     The primary objective of this study is to investigate whether bicalutamide given in     combination with anastrozole once daily for 12 months is effective in treating testotoxicosis     in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in     height, and development of muscles and sexual organs .   "
172736|NCT00094341|"     The purpose of this study is to determine the preference of RA patients for the new Enbrel®     (etanercept) pre-filled syringe in patients who are already taking Enbrel®.   "
172737|NCT00094354|"     The purpose of this study was to examine the needs, concerns, stigmas, and social networks of     HIV infected former plasma donors (FPDs) and their relatives in Fuyang, Anhui Province,     China. Interviews and focus groups were used to collect data in preparation for a future,     larger behavioral study for HIV infected individuals in China.   "
172738|NCT00094367|"     This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of     lamivudine once-daily as a single tablet were just as likely to have adverse events compared     to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate     tablets twice-daily.   "
172739|NCT00094380|"     The purpose of this study is to examine the safety of a single dose of RG2077 in patients     with systemic lupus erythematosus (SLE) who are currently receiving cyclophosphamide. This     study will also determine if RG2077 is effective in decreasing disease activity in these     patients.      Study hypothesis: CTLA4-Ig mediates a T cell costimulatory blockade that effectively induces     an antigen-specific nonresponsiveness in T cells.   "
172779|NCT00094926|"     The purpose of this study is to examine the safety and effectiveness of the long acting     injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with     treatment as usual (TAU), in bipolar disorder patients who had more than 4 mood episodes in     the past year.   "
172740|NCT00094393|"     This study will examine children with Hutchinson-Gilford Progeria syndrome, a genetic disease     that causes many changes to the body over time, including heart disease, bone changes, hair     loss, and joint and skin changes. Often called a premature aging disease, progeria does not     mimic aging completely. This study will examine which body systems are affected in progeria     and how each system is affected over time in order to try to develop new treatments.      Patients with progeria who are between 6 months and 70 years of age and who are able to     travel to the NIH in Bethesda, Md., may be eligible for this 5- to 10-year study.      Participants come to the NIH Clinical Center for evaluation every 2 years. Each 4-5 day visit     includes the following tests and procedures:        -  Medical history and physical examination        -  Blood tests to analyze cardiovascular risk factors, blood counts, blood chemistries, and          for research        -  Urine tests for sugar and proteins        -  Photographs to study growth problems        -  X-ray studies to determine bone density and body composition, such as body fat and          muscle        -  Electrocardiogram (EKG) and echocardiogram (heart ultrasound) to study the heart and          blood vessels        -  Lung function tests to measure energy consumption and lung capacity        -  Skin biopsy (surgical removal of a small skin sample) to examine cellular changes        -  Hearing tests        -  Eye examination to evaluate eyesight, eye pressure and structures of the eye        -  Physical therapy evaluation with stretching and exercises to measure how the joints bend          and straighten        -  Dental examination, including X-rays        -  Meeting with a nutritionist who will track the patient's food intake and take body          measurements        -  Magnetic resonance imaging (MRI) for patients who are old enough to undergo the          procedure without sedation. This test uses a magnetic field and radio waves to examine          body organs. For this test, the patient must lie still in the scanner, a narrow          cylindrical tube.      Patients are provided the results of their medical tests. Information about the patient is     submitted to the PRF Cell and Tissue Bank in Peabody, Massachusetts.   "
172741|NCT00094406|"     This study will examine in healthy volunteers how breathing carbon monoxide (CO) affects lung     inflammation. Severe lung inflammation sometimes develops in patients with pneumonia or     patients who develop serious blood stream infections. Studies in the laboratory and in     animals show that CO can decrease lung inflammation.      Healthy volunteers between 18 and 40 years of age who do not smoke, are not taking any     medications, do not have asthma, are not allergic to sulfa- and penicillin-based drugs, and     are not pregnant may be eligible for this study. Candidates are screened with a medical     history and physical examination, blood and urine tests, electrocardiogram (EKG), and chest     x-ray. Subjects are enrolled in either a pilot study or the main study.      Participants undergo bronchoscopy and bronchoalveolar lavage to study the effects of     endotoxin (a component of bacteria that causes inflammation similar to that in patients with     lung infections) on lung function. Before the procedure, a small plastic tube (catheter) is     placed in a vein to collect blood samples and another is placed in an artery to check blood     pressure. For the bronchoscopy, the mouth and nasal airways are numbed with lidocaine, and a     bronchoscope (thin flexible tube) is passed through the nose into the airways of the lung. A     small amount of salt water is squirted through the bronchoscope into one lung and then salt     water containing endotoxin is squirted into the other lung.      Following the bronchoscopy, subjects are treated with either CO or room air (placebo) for 6     hours. (Subjects in the pilot study receive treatment for only 3 hours). The gas is delivered     through a cushioned mask placed over the nose and mouth. The amount of exhaled CO is measured     before, during, and after inhalation of the gas. For this measurement, subjects take a deep     breath to fill up their lungs and slowly exhale into a mouthpiece connected to a measuring     device until they feel their lungs are empty.      After the CO treatment, a second bronchoscopy is done to examine how the lung responded to     the CO or room air. This is studied in two ways. To sample the air, a large needle is used to     withdraw air through the bronchoscope over about 3 seconds. Then the areas of the lung that     were squirted with salt water alone and with endotoxin and salt water and are rinsed (lavage)     and cells and secretions are collected.   "
172742|NCT00094419|"     The purpose of this study is to identify the types of and frequency of use of complementary     and alternative medicine (CAM) strategies among low-income Caucasian and African American     adults with persistent asthma. The overall goal is to collect data that will increase     understanding of health beliefs and behaviors in people with low-income backgrounds so that     studies can be created that may help modify and improve patients' symptoms of asthma.   "
172743|NCT00094432|"     The purpose of this study is to evaluate several doses of aripiprazole in patients with     bipolar depression.   "
172744|NCT00094445|"     The goal of this clinical research study is to learn if treatment with curcumin can help     shrink or slow the growth of pancreatic cancers. The effect of curcumin on the way pancreatic     cancer cells function and the safety of treatment with curcumin will also be studied.   "
172745|NCT00094458|"     The purpose of this study is to assess the safety and effectiveness of three different     treatments for patients with Crohns disease who have not responded to previous treatment with     a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients     will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an     immunosuppressant or drug used to suppress the immune system) or a combination of both for up     to 34 weeks. This research study will involve approximately 500 patients. The main study     involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks     (approximately 5 months) is optional for patients who successfully complete the main study. A     country-specific study extension of open label infliximab treatment for an additional 1 year     is optional for patients who successfully complete the main study extension.   "
172747|NCT00094497|"     The purpose of this study is to determine whether treatment with etoposide, doxorubicin,     cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane     (Sz/M) in patients with advanced adrenocortical carcinoma (ACC) whose disease is not amenable     to complete surgical resection.   "
172748|NCT00094510|"     This study will use magnetic resonance spectroscopy (MRS) and the drug gabapentin to examine     the role of the brain chemical gamma-amino-butyric acid (GABA) in regulating emotions in     healthy people. Gabapentin, which is used to treat epilepsy, increases GABA concentrations in     the brain. MRS, similar to magnetic resonance imaging (MRI), is a diagnostic test that uses a     magnetic field and radio waves to produce images of the brain.      Non-smoking, healthy normal volunteers between 18 and 60 years of age may be eligible for     this study. Candidates are screened with a medical history and physical examination,     psychiatric evaluation, blood and urine tests, and an electrocardiogram (EKG).      At three separate clinic visits, participants are given either gabapentin or a placebo (an     inactive look-alike capsule). They take placebo at one visit, 600 mg of gabapentin at another     visit, and 1200 mg of gabapentin at another visit. One hour after taking the capsules, the     amount of GABA in the brain is measured by MRS. For this procedure, the subject lies on a     table that moves into the MRI scanner (a narrow cylinder), wearing earplugs to muffle loud     knocking and thumping sounds that occur during the scanning process. The procedure lasts     about 45 to 60 minutes, during which the patient is asked to lie still for up to a few     minutes at a time.   "
172749|NCT00094523|"     This study was designed to evaluate and compare safety, tolerability of subjects who     successfully suppress HIV-1 on their first PI regimen to those who switch to fosamprenavir.     This is a 48-week study, where subjects who were assigned to be in their original PI-group     have the option of switching to fosamprenavir on week 24. Prior to being assigned their     treatment group, subjects had to be suppressed for at least three months. All subjects also     take a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors.   "
172750|NCT00094536|"     The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used     to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive     menstrual bleeding) due to benign causes. This is a non-incisional procedure, which can be     performed in a physicians office with minimal sedation.      Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting of     a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze of 6     minutes with the Cryoprobe repositioned in the contralateral cornu.      Since completion of the early studies, many physicians have experimented with varying freeze     patterns using longer freeze durations and/or additional freezes at the fundus and the lower     uterine segment. The results, as reported in the literature, indicate that these extended     freeze patterns produce significantly better results than the original regimen.   "
172751|NCT00094549|"     The goals of this study are:      A. To determine whether olanzapine can help patients with bipolar disorder who currently have     mild to moderate mania.      B. To assess the safety of olanzapine and any side effects that might be associated with it,     as well as the quality of life and functioning of patients treated with olanzapine.      C. To assess how olanzapine compares to divalproex.   "
172752|NCT00094562|"     The purpose of this study is to evaluate the safety and effectiveness of fish oil supplements     in maintaining weight in people with disease-related weight loss and/or cachexia.   "
172753|NCT00094575|"     A multi-center, randomized clinical trial that will compare endovascular repair with standard     open surgery in the repair of abdominal aortic aneurysms (AAA). Long and short-term results     as well as the cost and quality of life associated with these two strategies for AAA repair     will be compared.   "
172754|NCT00094601|"     This study will examine how the brain chemical dopamine affects memory, reasoning, and other     thought processes in people with Parkinson's disease with and without dementia and in healthy     control subjects.      Healthy normal volunteers and people with Parkinson's disease who are between 40 and 85 years     of age may be eligible for this study. Pregnant women with Parkinson's disease and     breastfeeding normal volunteers are excluded. Candidates are screened with a physical and     neurological examination, blood tests, a brief mental test called the Mini Mental Status     Examination, and other tests designed to assess memory, learning, reasoning, and other     thought processes. Patients with Parkinson's disease also undergo a more thorough mental     evaluation called the Mattis Dementia Rating Scale. The study requires about 15 hours over 4     or 5 outpatient visits to NIH.      Participants undergo two positron emission tomography (PET) scans on two separate days and a     magnetic resonance imaging (MRI) scan, as follows:      PET Scans      The two PET procedures are done the same way, except one uses a radioactive tracer called     [(18)F]DOPA and one uses a tracer called [(11)C]NNC-112. A catheter (small plastic tube) is     placed in a vein in the subject's arm for injection of the tracer. The subject lies on the     scanner bed and a special mask is fitted to his or her head to hold it in place during the     procedure. Just before injecting the tracer, a 10-minute transmission scan is done of the     head using a tracer called (68)Ge. Then, a series of scans using one of the two study tracers     ([(18)F]DOPA or [(11)C]NNC-112 are done for about 90 minutes. About 1 hour before injection     of the [(18)F]DOPA tracer, subjects take 200 mg of the drug carbidopa by mouth to help the     tracer work properly. Blood pressure, breathing and heart are monitored before and after     injection of the [(11)C]NNC-112 tracer.      Patients with Parkinson's disease are taken off all Parkinson's medications the night before     the [(18)F]DOPA scan and their motor function is tested the following morning before the     scans are done, using the Unified Parkinson's Disease Rating Scale. Patients can resume all     medications except L-DOPA (including Sinemet) after the movement test, and they can resume     L-DOPA after the PET scan is finished.      MRI Scan      MRI uses a strong magnetic field and radio waves to obtain images of the brain. The subject     lies still on a table that slides inside the scanner, a metal cylinder. They wear ear plugs     to muffle loud knocking sounds that occur during the scanning and can communicate with the     MRI staff at any time through an intercom.   "
172755|NCT00094614|"     The goals of this study are:        -  To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of          atropine versus weekend-only use of atropine.        -  To compare the proportion of patients achieving a complete treatment response (defined          as amblyopic eye acuity >20/25 or equal to that of the sound eye in the absence of a          reduction in the sound eye acuity from baseline) with daily atropine versus weekend-only          atropine.   "
172756|NCT00094627|"     The purpose of the study is to test the safety and effectiveness of the Investigational Drug     on insomnia.   "
172757|NCT00094640|"     The goals of this study are to:      Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different     points in time after an injection, and compare these levels to the amount of olanzapine in     the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets     or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection).   "
172774|NCT00094861|"     The purpose of this study is to determine if palifermin will reduce the incidence of     dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation     chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).   "
172758|NCT00094653|"     The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab,     BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with     previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated,     as well as patient responses and time to disease progression. Eligible patients are those who     in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or     temozolomide, have 1) relapsed following an objective response (partial response/complete     response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not     tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of     three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379     alone, or MDX-010 in combination with MDX-1379.   "
172759|NCT00094666|"     The purpose of the study is to test the safety and effectiveness of an Investigational Drug     on insomnia in the elderly.   "
172760|NCT00094679|"     The goals of this study are:        -  To determine whether the visual acuity improvement obtained with part-time (6 hours)          patching is equivalent to the visual acuity improvement obtained with minimal patching          (2 hours) for moderate amblyopia.        -  To develop more precise estimates than currently available for the visual acuity          improvement that occurs during treatment of amblyopia with patching.        -  To identify factors that may be associated with successful treatment of amblyopia with          patching.   "
172761|NCT00094692|"     The goals of this study are:        -  To determine the response rate of treatment of amblyopia in 7 to <18 year olds.        -  To determine the frequency of recurrence of amblyopia in 7 to <18 year olds after          discontinuation of amblyopia treatment.   "
172762|NCT00094705|"     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and     subtropical regions of the world. The purpose of this study is to test the safety of and     immune response to a new dengue virus vaccine in healthy adults.   "
172763|NCT00094718|"     West Nile (WN) virus infection is an emerging disease; WN infection may lead to paralysis,     coma, and death. The purpose of this study is to test the safety of and immune response to a     WN vaccine in healthy adults. The vaccine is based on a live attenuated vaccine developed     against dengue virus.   "
172765|NCT00094744|"     The goals of this study are:        -  To determine whether the visual acuity improvement obtained with part-time (6 hours)          patching is equivalent to the visual acuity improvement obtained with full-time patching          (all or all but one waking hour) for severe amblyopia.        -  To develop more precise estimates than currently available for the visual acuity          improvement that occurs during treatment of amblyopia with patching.        -  To identify factors that may be associated with successful treatment of amblyopia with          patching.   "
172766|NCT00094757|"     The purpose of this study is to determine the safety and effectiveness of an investigational     drug in patients with Type 2 Diabetes Mellitus.   "
172767|NCT00094770|"     The purpose of this investigational study is to determine the safety and effectiveness of an     investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).   "
172768|NCT00094783|"     This study will examine the use of magnetic resonance imaging (MRI) instead of x-rays to     guide angioplasty in patients who require these treatments to treat blockages in leg     arteries. Angioplasty is a procedure in which a balloon is inflated in a blocked artery to     improve blood flow. MRI uses a magnetic field and radio waves rather than x-rays to show     pictures of body tissues and organs. MRI shows all soft tissue, including the arteries,     blood, and other organs, while the usual x-ray technique shows only the lumen of the artery     when it is filled with dye, but not the vessel walls.      Patients 18 years of age and older who require angioplasty with or without stenting to     restore blood flow to the leg may be eligible for this study.      Participants undergo the usual angioplasty procedure. The skin in the patient's groin area is     numbed and a catheter is placed into the groin artery. The patient is given a blood-thinning     medicine, and then other catheters are inserted to measure blood pressure and to inject a     contrast dye to take pictures. Balloon catheters are inflated to open the blockage and, if     needed, stents are put in place to maintain the opening. When the blood thinner wears off,     the catheters are removed.      Most of the procedure is conducted using MRI instead of X-rays to visualize the arteries and     blockages. The patient is moved back and forth between the x-ray and MRI machines in a     specially designed laboratory. If necessary, stenting, placement of a wire mesh to hold open     the artery, is done using conventional x-ray techniques.      The entire procedure, including MRI, takes up to 4 hours.   "
172769|NCT00094796|"     This study will examine whether the anti-diabetes medicine rosiglitazone can safely and     effectively reverse the early problems of type 2 diabetes and delay the onset of disease in     people with pre-diabetes. The underlying problem in people with diabetes or pre-diabetes is     insulin resistance (lowered sensitivity to insulin) resulting in poor glucose (sugar)     regulation. Rosiglitazone improves the body's sensitivity to insulin.      Patients 21 years of age and older who have type 2 diabetes or who are pre-diabetic (glucose     intolerant/insulin resistant) may be eligible for this study. Candidates are screened with a     medical history, physical examination, blood tests, echocardiography (heart ultrasound),     exercise test, brachial artery reactivity test (see below), and possibly a muscle biopsy.      Participants take one rosiglitazone tablet daily by mouth for 2 weeks. The dose is then     increased to two tablets daily for another 2 weeks and then to 4 tablets daily for the     remainder of the 12-week treatment period. In addition to treatment, patients undergo the     following tests and procedures:        -  Resting and exercise metabolic testing: The amount of oxygen taken in and carbon dioxide          exhaled during breathing is measured while the patient rests in a chair and then while          he or she exercises on a stationary bicycle or treadmill. Both at rest and during          exercise, the patient wears a facemask that measures the amount of oxygen used. During          exercise, heart rate is monitored with electrodes on the chest, arms, and thighs. The          exercise test is repeated three times, once to become familiar with the test, again the          next day to measure exercise capacity, and again 3 days later. The third test is less          strenuous and is optional.        -  Muscle biopsy (optional): A small area of skin over a calf muscle is numbed with a local          anesthetic and a 1-inch incision is made over the muscle. A small amount of muscle          tissue is taken and the incision is closed with stitches.        -  Brachial reactivity study: This ultrasound study tests how well the patient's arteries          widen. The subject rests on a bed for 30 minutes. An ultrasound measuring device is          placed over the artery just above the elbow. The size of the artery and blood flow          through it are measured before and after inflating a pressure cuff around the forearm.          The pressure cuff stops the flow of blood to the arm for a few minutes. After a          15-minute rest, a nitroglycerin tablet (medicine that causes blood vessels to relax) is          placed under the patient's tongue. Before and 3 minutes after the nitroglycerin is          given, the size of the artery and blood flow through it are measured again.        -  Blood samples: Blood samples are collected at the beginning and end of the study and at          study visits in between.        -  Study visits: Patients come to the Clinical Center biweekly or monthly for a follow-up          history, physical examination, and blood tests. At the end of the3-month treatment          period, they receive recommendations about possible treatment modifications to best          maintain glucose tolerance. Their physicians are informed of how their blood sugar was          controlled. Six months after completing the study, patients undergo a final study          evaluation and blood tests, and are then invited to return for yearly checkups after          that.   "
172770|NCT00094809|"     The purpose of this research study is to evaluate the safety and effectiveness of     pegfilgrastim in reducing grade 3/4 neutropenia when given after one of three chemotherapy     regimens (FOIL, FOLFOX or FOLFIRI) in patients with locally advanced or metastatic colorectal     cancer. This study is considered to be investigational because the time between receiving     pegfilgrastim and the next cycle of chemotherapy is only 11 days.   "
172771|NCT00094822|"     The purpose of this research study is to evaluate the safety and effectiveness of Neulasta®     (pegfilgrastim) in reducing infection when given on the same day versus one day after the     completion of chemotherapy (docetaxel and carboplatin) in patients with advanced or     metastatic non-small cell lung cancer (NSCLC). This study is considered to be     investigational because previous studies with Neulasta® used next day dosing and not same     day dosing.   "
172772|NCT00094835|"     The purpose of this trial is: - To characterize the safety profile of motesanib when used in     combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in     patients with advanced non-small cell lung cancer (NSCLC). - To establish the pharmacokinetic     (PK) profile of motesanib when it is used in combination with CP, with panitumumab, or with     CP and panitumumab. - To compare the paclitaxel and motesanib PK profiles when the     medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart. - To     characterize the panitumumab and paclitaxel exposure in the combination regimens of motesanib     with CP, motesanib with panitumumab, or motesanib with CP and panitumumab. - To describe the     objective response rate (ORR) in each dose cohort. - To measure the immunogenicity of     panitumumab in patients administered motesanib with panitumumab and motesanib with CP and     panitumumab.   "
172773|NCT00094848|"     The purpose of this study is to evaluate the safety, efficacy and exposure to TRM-1 in     subjects with relapsed or refractory Non-Hodgkin's Lymphoma (NHL).   "
172775|NCT00094874|"     Acupuncture is a form of Chinese medicine that has been in existence for more than a thousand     years. This clinical trial performs two types of acupuncture on traditional 'bladder' points     to determine if one type demonstrates improvement over the other. In the first type needles     stimulate acupuncture points on the skin, and in the second type the needles penetrate     through the skin similar to how acupuncture is usually performed. The technique is done     through shields so that people will not know what type of acupuncture they receive.      Patients must have at least moderately severe disease as determined by a urologist. They must     be willing not to change their medical regimen for the duration of the trial. Patients will     receive twelve treatments over six to twelve weeks. They will be asked to fill out symptom     questionnaires and bladder diaries at regular intervals to monitor change. All treatment is     free of charge, and patients who complete the trial will receive a small stipend.   "
172776|NCT00094887|"     This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain     to go away in patients who are in sickle cell crisis. NO is important in regulating blood     vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that     line the blood vessels. It is also transported from the lungs by hemoglobin in red blood     cells.      Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or     other blood problems causing sickle cell disease) may be eligible for this study. Patients     whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood     tests and a chest x-ray to look at the lungs and heart.      Participants are admitted to the hospital in a pain crisis. They are evaluated and then     randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2)     standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes     up most of the air we breathe and is not known to help in sickle cell disease.      For the first 8 hours of the study, patients receive placebo or NO through a facemask. The     mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a     meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic     tubing that rests under the nose) that may be taken off only while showering or using the     restroom. Patients are questioned about the severity of their pain when they start the study     and then every few hours while they are in the hospital. Their vital signs (temperature,     breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas     for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go     home. Patients are followed up about 1 month after starting the study by a return visit to     the hospital or by a phone call.   "
172781|NCT00094952|"     The main goal of this project is to use imaging and biomarkers to identify cognitively normal     elderly people who are at increased risk for developing mild cognitive impairment (MCI). MCI     is the earliest clinically detectable evidence for brain changes due to Alzheimer's disease     (AD). The second goal of this project is to describe the inter-relationships among anatomical     biomarkers, cerebrospinal fluid biomarkers, and cognition measures in those elderly people     who develop MCI.   "
172782|NCT00094965|"     This trial is a phase II study in patients with advanced gastrointestinal (GI) malignancies     who will be assigned to one of 4 cohorts (normal, mild, moderate and several renal     dysfunction) based on their baseline measured creatinine clearance then treated with FOLFOX4.      Standard bone marrow and liver function inclusion and exclusion criteria must be met prior to     study treatment. FOLFOX4 in the study is given every 2 weeks (1 cycle = 2 weeks) for up to 12     cycles unless there are treatment delays to allow for recovery from toxic effects. Dose     modifications are included for protocol specified toxicities. After 12 treatment cycles on     study, patients who are having a beneficial disease response may continue to have oxaliplatin     supplied off study to continue the treatment regimen until disease progression, prohibitive     toxicity or death.      Oxaliplatin pharmacokinetic studies (plasma and urine) are planned during cycles 1 and 2 on     each patient. Creatinine clearance will be assessed every 2 cycles and disease status will be     assessed every 3 cycles of treatment during the study.   "
172783|NCT00094978|"     This study will test the safety and effectiveness of two experimental medicines -     depsipeptide and flavopiridol - given together to treat cancers of the lung, esophagus, and     pleura. It will determine the highest dose that these drugs can safely be given together and     will test whether giving them together works better at shrinking tumors than giving either     one alone.      Patients 18 years of age and older with cancer of the lung, esophagus, or pleura, or other     cancers that have spread to the lungs or pleura may be eligible for this study. Candidates     are screened with a medical history and physical examination, blood tests, electrocardiogram     (EKG), x-rays and scans, pulmonary function tests, and a tumor biopsy (removal of a small     piece of tumor tissue for microscopic examination).      Participants are admitted to the hospital for treatment for approximately 10 days during each     28-day treatment cycle. Depsipeptide is infused through an arm vein or central venous     catheter (tube placed in a large vein in the neck or chest) for 4 hours. When this infusion     is complete, flavopiridol is infused over 72 hours. The dose of depsipeptide is increased     four times over the period of the study with successive groups of patients, and flavopiridol     is increased once to determine the maximum safe dose of giving these drugs together.      Blood tests are done before and after each depsipeptide infusion and 3 more times for the     next 24 hours, and at various times over 4 days during the flavopiridol infusion to evaluate     the effects of the medicines. Samples are also drawn periodically throughout the treatment     cycle to evaluate safety. Heart function is monitored with several EKGs before and during the     depsipeptide doses. The drug has shown effects on EKG tracings, but does not appear to injure     the heart muscle.      Tumor biopsies are done before treatment begins and on the fifth day of the first treatment     cycle. The biopsies may be done either in the operating room by passing a tube (bronchoscope)     down the throat and into the lungs or in the Radiology Department using a thin needle put     through the chest wall into the tumor. For the bronchoscopy, numbing medicine is sprayed into     the back of the throat to reduce discomfort, and for the needle biopsy, the skin over the     biopsy area is numbed. Optional repeat biopsies may be requested before the start of the     second treatment cycle and on day 5 of that cycle. (The repeat biopsies are not required for     participation in the study.) At the time of each tumor biopsy, a buccal mucosal biopsy is     also done. This involves scraping a tongue depressor along the inside of the mouth to collect     cells for examination.      At the end of the first treatment cycle, patients return to NIH for evaluation with a     physical examination, blood work, x-rays, and scans of the chest, abdomen, pelvis, and brain.     Patients who are not experiencing significant drug side effects are offered a second cycle,     exactly like the first. The two cycles complete one course of treatment, after which patients     once again return to NIH for evaluation. Additional treatment cycles may be offered to     patients whose tumors have shrunk or remained stable with therapy. Patients whose tumors have     not responded to therapy or who have developed severe drug side effects are taken off the     study.   "
172784|NCT00094991|"     The purpose of this study is to learn more about how muraglitazar lowers blood sugar in     people with type 2 diabetes. The safety of this treatment will also be studied.   "
172785|NCT00095004|"     The purpose of this study is to test the effectiveness of an approved drug in the early     treatment of migraine.   "
172786|NCT00095017|"     The purpose of this study is to compare the effectiveness of an investigational drug versus     placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or     prostate cancer and a bone neoplasm. Patients in the study will be taking opioids to treat     moderate to severe pain for their bone metastases and will remain on their opioids during the     entire course of the study.   "
172787|NCT00095030|"     The purpose of this clinical research study is to learn whether a muraglitazar-metformin     combination is at least as effective as a glimepiride-metformin combination to treat type 2     diabetics who are not sufficiently controlled with metformin alone. The safety of this     treatment will also be studied.   "
172788|NCT00095043|"     The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.   "
172789|NCT00095056|"     The purpose of this study is to determine the safety and tolerability of an investigational     drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic     Renal Insufficiency (inadequate kidney function).   "
172790|NCT00095069|"     The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with     insomnia.   "
172791|NCT00095082|"     This trial is conducted in Europe and the United States of America (USA). The purpose of this     study is to test whether insulin detemir is a safe and at least as effective alternative to     insulin glargine for the control of blood glucose in basal/bolus therapy in patients with     type I diabetes.   "
172792|NCT00095095|"     Lumbar spinal fusion is commonly performed as a last resort in patients with chronic low     back pain caused by degenerative changes and instability of the spine. The aim of this study     is to compare two fusion devices, which are used in spinal surgery in order to promote the     fusion of two lumbar vertebrae.   "
172793|NCT00095108|"     This study is being done to see if an experimental drug called recombinant interleukin-21     (rIL-21) when given to patients with stage 4 malignant melanoma or stage 4 kidney cancer is     safe and has any effect on these types of cancers.   "
172794|NCT00095121|"     The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for     the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18     years) following 48 weeks of placebo-controlled, double-blind treatment and following an     additional 192 weeks of open-label adefovir dipivoxil treatment.   "
172795|NCT00095134|"     The purpose of this trial is to evaluate the efficacy and safety of risperidone versus     placebo in subjects with Major Depressive Disorder with sub-optimal response to     antidepressant therapy.   "
172797|NCT00103181|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy in different ways may kill any tumor cells that remain after surgery. It is not yet     known whether whole breast radiation therapy is more effective than partial breast radiation     therapy in treating breast cancer.      PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see     how well it works compared to partial breast radiation therapy in treating women who have     undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.   "
172798|NCT00103194|"     This phase II trial studies how well lapatinib ditosylate works in treating patients with a     rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that     prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth and may delay or     prevent the progression of prostate cancer.   "
172799|NCT00103207|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them.      PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with     recurrent or stage IIIB or stage IV lung cancer.   "
172800|NCT00103220|"     This phase I trial is studying the side effects and best dose of SJG-136 in treating patients     with advanced solid tumors. Drugs used in chemotherapy, such as SJG-136, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.   "
173021|NCT00098202|"     Malnutrition is a serious health problem in the developing world. This study looks at the     effects of changing the type of basic food staple (corn) used in Guatemala and infant zinc     supplementation on infants' growth, development, and illnesses from infectious diseases.   "
172801|NCT00103233|"     RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Trastuzumab may also help vinorelbine work     better by making tumor cells more sensitive to the drug. Giving vinorelbine together with     trastuzumab may be an effective treatment for breast cancer. It is not yet known whether     giving vinorelbine together with trastuzumab is more effective than vinorelbine alone in     treating breast cancer.      PURPOSE: This randomized phase III trial is studying vinorelbine and trastuzumab to see how     well they work compared to vinorelbine alone in treating women with progressive metastatic     breast cancer.   "
172802|NCT00103246|"     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a     certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy     using silicon phthalocyanine 4 may be effective against skin cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic     therapy using silicon phthalocyanine 4 in treating patients with actinic keratosis, Bowen's     disease, skin cancer, or stage I or stage II mycosis fungoides.   "
172803|NCT00103259|"     This randomized phase II trial is studying bortezomib and irinotecan to see how well they     work compared to bortezomib alone in treating patients with locally recurrent or metastatic     squamous cell carcinoma of the head and neck. Bortezomib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     irinotecan, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving bortezomib together with irinotecan may kill     more tumor cells. It is not yet known whether giving bortezomib together with irinotecan is     more effective than bortezomib alone in treating head and neck cancer.   "
172804|NCT00103272|"     This phase I trial is studying the side effects and best dose of     17-N-allylamino-17-demethoxygeldanamycin and bortezomib in treating patients with relapsed or     refractory hematologic cancer. Drugs used in chemotherapy, such as     17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving     17-N-allylamino-17-demethoxygeldanamycin together with bortezomib may kill more cancer cells.   "
172805|NCT00103285|"     This randomized phase III trial is studying different combination chemotherapy regimens and     comparing how well they work in treating patients with newly diagnosed acute lymphoblastic     leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells.   "
172806|NCT00103298|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, leucovorin, oxaliplatin, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     and giving the drugs in different ways may kill more tumor cells.      PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan     followed by combination chemotherapy works in treating patients with unresectable liver     metastases from colorectal cancer.   "
172807|NCT00103311|"     This randomized phase II trial is studying how well SB-715992 works in treating patients with     advanced or metastatic colorectal cancer. Drugs used in chemotherapy, such as SB-715992, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing.   "
172808|NCT00103324|"     This phase II trial is studying how well lapatinib works in treating patients with locally     advanced or metastatic stomach cancer. Lapatinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth   "
172809|NCT00103337|"     This randomized phase II trial is studying how well cilengitide works in treating patients     with metastatic prostate cancer. Cilengitide may stop the growth of prostate cancer by     blocking blood flow to the tumor   "
172810|NCT00103350|"     TG100-115 is able to reduce the size of heart attacks in pre-clinical models. The hypothesis     of this study is that TG100-115 can be given safely to patients who suffer a heart attack and     undergo angioplasty to restore blood flow. We will also evaluate whether TG100-115 reduces     heart muscle damage.   "
172811|NCT00103363|"     RATIONALE: Screening tests, such as sputum cytology, may help doctors find tumor cells early     and plan better treatment for lung cancer.      PURPOSE: This phase II trial is studying how well sputum cytology works in screening heavy     smokers for lung cancer.   "
172812|NCT00103376|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such     as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making     androgens. Giving bortezomib with hormone therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bortezomib with or without hormone     therapy works in treating patients with relapsed prostate cancer.   "
172813|NCT00103389|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. PI-88     may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. It may     also help docetaxel work better by making tumor cells more sensitive to the drug. Giving     docetaxel together with PI-88 may kill more tumor cells. It is not yet known whether giving     docetaxel together with PI-88 is more effective than docetaxel alone in treating non-small     cell lung cancer.      PURPOSE: This randomized phase II trial is studying docetaxel and PI-88 to see how well they     work when given together compared to docetaxel alone in treating patients with stage IIIB or     stage IV non-small cell lung cancer.   "
172839|NCT00104065|"     CG53135-05, a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under     investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring     side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem     cell transplant. The objective of this Phase II trial is to evaluate the safety and efficacy     of CG53135-05 when administered as a single dose to patients at risk for developing oral     mucositis.   "
172814|NCT00103402|"     The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the     alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic     prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg     capsule), FDA approved medication for an indication in benign prostatic hyperplasia (BPH).     The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH     has been documented in a number of placebo-controlled studies. A number of small studies have     also suggested that alfuzosin ameliorates CP/CPPS symptoms through a similar alpha-blockade     mechanism. This study will enable further testing of this hypothesis   "
172815|NCT00103415|"     During one year, 5-8% of the population will suffer from major depression. Some of the key     symptoms are loss of interest in daily activities, loss of energy and sleeping disturbances.     The financial consequences of this disease is estimated to be more than 30 million pounds per     year in Great Britain and USA alone. There is an increasing interest in the effect exercise     has on depression. Smaller studies indicate that exercise is a good treatment for depression.     This study will be a large scale randomized trial and will hopefully bring important     knowledge on the effects exercise has on depression.      We will compare the effect endurance training, weight-lifting exercise and a control group     has on depressive symptoms after 4 months training, twice a week.   "
172816|NCT00103428|"     V-0039 is a Phase 1/2 dose escalation trial of CG7870 in combination with Docetaxel in     metastatic hormone-refractory patients who have not received chemotherapy.      All patients will receive docetaxel. In the dose escalation phase of the study, patients will     receive treatment intravenously with CG7870 at one of up to four dose levels. In the Phase 2     portion of this study, additional patients will be added at the maximum tolerated dose that     is determined in Phase 1.   "
172817|NCT00103454|"     The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg     once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent     subjects (12 years of age and older) with perennial allergic rhinitis (PAR).   "
172818|NCT00103467|"     The purpose of this phase 1 study is to evaluate the safety and immunogenicity of rPA102     vaccine, using anthrax vaccine adsorbed (AVA) as a comparator.   "
172819|NCT00103493|"     The purpose of this study is to evaluate whether an oral health education program that is     tailored to caregivers' understanding and acceptance of information on how to prevent tooth     decay will lead to improvement in behaviors conducive to good oral health and reduction in     tooth decay in his or her children.   "
172820|NCT00103506|"     The purpose of this study is to evaluate time to progression, overall survival, response rate     and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE     vs. VELCADE monotherapy.   "
172821|NCT00103519|"     This study will assess the safety and efficacy of DITPA relative to placebo in patients with     New York Heart Association (NYHA) class III or IV congestive heart failure (CHF) who have low     serum T3. DITPA is an investigational agent.   "
172822|NCT00103532|"     Risk behaviors and their associated adverse health outcomes are becoming increasingly     problematic among HIV-infected youth. This study is being conducted to test whether a brief     motivational enhancement (ME) intervention will help reduce health risk behaviors (drug and     alcohol use, sexual risk behavior, poor adherence to medications) among HIV+ youth.   "
172823|NCT00103844|"     The primary purpose of this study is to estimate the major cytogenetic response rates of     BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome     positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of     400-600 mg/d.   "
172824|NCT00103857|"     The purpose of this study is to determine the safety and effectiveness of an investigational     drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).   "
172825|NCT00103870|"     The purpose of this study is to determine whether engaging in music listening tasks can     reduce the perception of pain and provide nondrug pain relief.      Study hypotheses: 1) Performing a highly engaging listening task reduces psychophysiological     arousal to painful stimuli. 2) Psychophysiological arousal to painful stimuli is a function     of the complexity of the auditory signal. 3) Signal complexity and task difficulty interact     to produce the greatest engagement and maximum reduction in psychophysiological arousal to     painful stimuli.   "
173836|NCT00116870|"     The purpose of this study is to determine whether significant alterations in serum     lipoproteins as provided by the drug lovastatin can substantially reduce atherosclerosis     progression or even induce regression.   "
172826|NCT00103883|"     Identifying young people with early HIV-1 infection is important for increasing linkage to     care, for behavioral counseling, and for enrolling individuals into programs that can provide     effective interventions to disease progression and improve outcome. This study will develop     and evaluate a saliva-based sensitive/less sensitive (S/LS) assay for differentiating persons     with recent HIV-1 infection (less than 133 days) from those with established HIV-1 infection.   "
172827|NCT00103896|"     This is Phase II of a three stage project whose overall goals are to develop viable     community-based HIV prevention interventions and to form and maintain the necessary community     collaborations to support such Adolescent Trials Network (ATN) research activities.      This phase will describe specific locations within high-risk areas where youth, ages 12-24,     spend time. HIV risk behaviors, social networking patterns and HIV prevalence among youth at     these venues will be assessed by administering anonymous computerized interviews to eligible     and willing youth. This information will be shared with community partners during scheduled     working group meetings.   "
172828|NCT00103922|"     This study was designed to determine if the investigational drug is effective and safe in     individuals with COPD (chronic pulmonary disease)   "
172829|NCT00103935|"     Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily     dosage form currently under investigation as a potential treatment for people with type 2     diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of     Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes     mellitus.   "
172830|NCT00103948|"     This is an 18-week, prospective, multi-center, randomized, double-blind, placebo-controlled,     (1:1) parallel-group study.   "
172840|NCT00104078|"     The purpose of this phase I/II, multicenter, safety trial is to study MYO-029 in adult     patients with muscular dystrophy.   "
172841|NCT00104091|"     Immunotoxin therapy may be effective in treating malignant glioma. Immunotoxins can locate     tumor cells and kill them without harming normal cells.   "
172831|NCT00103961|"     This is a long-term follow-up study of people who are identified during acute or recent HIV     infection and are being followed at clinical research sites associated with the Acute HIV     Infection and Early Disease Research Program (AIEDRP). The purpose of this study is to     collect data on the immunological and virologic responses that occur early in the course of     HIV infection in treatment-naive and treatment-experienced HIV infected adults.      Study hypothesis: This study will examine the immunological responses that occur early in the     course of HIV infection in treated and untreated individuals. The long-term follow-up of     these subjects will help identify host immunological and genetic factors along with     therapeutic strategies associated with control of viremia and delayed disease progression. In     addition, this cohort will provide the recruiting mechanism to support future trials of     therapy to restore immune function. Furthermore, this cohort will provide a population     suitable to monitoring changing patterns in the transmission of drug resistant viral strains     while also evaluating ongoing behavioral risk factors associated with HIV transmission.   "
172832|NCT00103974|"     This research study is being done to evaluate the safety of BHT-3009 alone and when combined     with atorvastatin (Lipitor) in patients with multiple sclerosis (MS).   "
172833|NCT00103987|"     This study will examine brain and noradrenaline function in panic disorder. Noradrenaline is     a brain chemical that is involved in the regulation of emotion, anxiety, sleep, stress     hormones such as cortisol, and other body functions that are disturbed in panic disorder.      Healthy normal volunteers and patients with panic disorder between 18 and 60 years of age may     be eligible for this study. Candidates are screened with psychiatric and medical histories, a     physical examination, blood and urine tests, and an electrocardiogram.      Participants undergo the following tests and procedures:        -  Blood draw to obtain DNA for genetic studies of panic disorder - particularly of a gene          that helps control noradrenaline activity - and to grow cell lines that can be frozen          and used for future research on the disorder.        -  Magnetic resonance imaging: MRI uses a magnetic field and radio waves to produce images          of body tissues and organs. For this procedure, the subject lies on a table that is          moved into the scanner (a narrow cylinder), and wears earplugs to muffle loud knocking          and thumping sounds that occur during the scanning process. The procedure lasts about 60          minutes, during which the patient is asked to lie still for 10 to 15 minutes at a time.        -  Yohimbine injection with PET scanning: Catheters (plastic tubes) are placed in two          veins, one to administer yohimbine, a drug that increases noradrenaline activity in the          body for about 60 minutes, and one to draw blood samples. Yohimbine often causes          temporary trembling, goosebumps, and clammy palms, and may cause emotions such as          elation, anxiety, panic attacks, or depression. During yohimbine administration,          subjects undergo positron emission tomography (PET) scanning. PET uses small amounts of          a radioactive chemical called [fluoro-18]-fluorodeoxyglucose that labels active areas          of the brain, showing patterns of glucose (sugar) metabolism. For the procedure, the          subject lies on the scanner bed, with a special mask fitted to his or her head and          attached to the bed to help keep the head still. A brief transmission scan is done          just before the radioactive tracer is injected in order to calibrate the scanner. After          the tracer is injected through the catheter, pictures are taken for about an hour, while          the subject lies still on the scanner bed.        -  Saline injection with PET scanning: The procedure is the same as that described above,          except a saline solution is administered as placebo instead of yohimbine.   "
172834|NCT00104000|"     This study will examine whether surface electrical stimulation on the skin of the throat     will: 1) move the larynx (voice box); 2) move the vocal folds in the larynx; and 3) cause     less movement of the larynx when applied during swallowing. It is important that the larynx     moves up and forward while swallowing so that food does not go into the airway. A device     called VitalStim® (Registered Trademark), which provides electrical stimulation to the skin     on the neck and under the chin, is widely used to treat people who have problems swallowing.     This study will determine if VitalStim can move the voice box or the vocal folds in the     larynx. This information is important for patients who have long-term problems raising or     closing their larynxes when they swallow.      Healthy volunteers between 20 and 60 years of age may be eligible for this study. Candidates     are screened with a medical history, physical examination, electrocardiogram, and     nasoendoscopy. For the latter procedure, the inside of the subject's nose is sprayed with a     decongestant, opening the nasal passages. A small flexible tube called a nasoendoscope is     passed through the nose to the back of the throat. The scope allows observation of the larynx     while the subject speaks, sings, whistles and makes prolonged vowel sounds.      Participants are familiarized with the VitalStim device before beginning the experimental     procedures. The device consists of two sets of electrodes and a stimulation unit. The     electrodes are placed on the neck and under the chin. Stimulation causes different     sensations, according to the intensity level. They include tingling/crawling, vibrating     warm/burning, and grabbing. Subjects then undergo the following procedures:        -  Nasoendoscopy with muscle stimulation: The inside of the nose is sprayed with a          decongestant and the nasoendoscope is passed through one nostril to the back of the          throat. Electrodes are placed on the throat area and under the chin. Stimulation is          delivered 10 times at various places on the neck and under the chin while the subject          sits quietly. This test shows if the vocal folds in the voice box move with surface          electrical stimulation.        -  Videofluoroscopy with muscle stimulation at rest and during swallowing: This is an x-ray          study of the head and neck during swallowing and at rest to determine how stimulation          affects the level of the voice box in the neck. Electrodes are placed under the chin and          on the throat. The subject swallows 5 milliliters of barium, a contrast material that          can be seen easily on x-ray. The x-ray machine is turned on for a few seconds at a time          during each swallow of the barium and another 10 times while the subject is remaining          still without swallowing.   "
172835|NCT00104013|"     The purpose of this study is to assess xaliproden's potential capacity of slowing the     deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's     disease. The patients participating in this study will take orally once daily xaliproden or     placebo (inactive substance pill).   "
172836|NCT00104026|"     This study will examine common features of gingival overgrowth (excessive growth of the gums     around the teeth) that develops in patients with the hereditary form of the condition and in     those who develop the condition as a side effect of medications. A better understanding of     gingival overgrowth may help scientists develop medications with fewer oral side effects.      Patients of any age with hereditary gingival fibromatosis and their blood relatives, and     patients of any age with gingival overgrowth who are taking medications associated with     development of the disorder, including phenytoin (diphenylhydantoin or Dilantin),     cyclosporine, and calcium-channel blockers, may be eligible for this study.      Participants undergo a medical and dental history, including a history of medication use;     detailed examination of the teeth, periodontium, head, and neck; photographs of teeth with     gingival overgrowth; dental x-rays; and blood tests. DNA is extracted from a blood sample to     look for genes related to gingival overgrowth.      Patients with gingival overgrowth are offered two options, as follows:        -  Tissue biopsy: A tissue sample is taken from each affected site, with a maximum of three          biopsies. For the procedure, lidocaine is first injected into the gum to numb the          tissue. Then, a cookie-cutter instrument is pushed into the numbed skin, and a small          piece of tissue is removed.        -  Gingivectomy: Surgical removal of the overgrown gingival.   "
172837|NCT00104039|"     Purpose:      This study will examine brain activity in children age 10-18 with disruptive behavior     problems, including conduct disorder (CD), oppositional defiant disorder (ODD), and attention     deficit hyperactivity disorder (ADHD), compared with children without behavioral problems.     Our goal is to examine differences in how emotions, social situations, and problem-solving     situations are processed in the brain across these groups of children.   "
172838|NCT00104052|"     The primary objective is to assess the safety, efficacy and tolerability of the combination     of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary     objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in     pediatric subjects with chronic hepatitis C.   "
172845|NCT00104143|"     This study will compare the effect of A4I antagonist and placebo on MRI lesions,on clinical     endpoints, and safety in patients with relapsing Multiple Sclerosis (MS). Eligible patients     will be randomized to receive placebo or A4I antagonist, 20mg, 80mg or 300mg, po bid.     Patients will undergo MRI brain scans and MS clinical evaluations at intervals throughout the     study. The anticipated time on study treatment is 3-12 months, and the target sample size is     100-500 individuals.   "
172846|NCT00104156|"     The purpose of this study is to evaluate the effectiveness of Qigong therapy, an ancient     Chinese practice, for pain relief and symptom improvement in people with knee osteoarthritis     (OA).      Study hypotheses: 1) Qigong therapy will result in greater reduction of pain and greater     symptom improvement than sham treatment. 2) Individuals with a history of complementary and     alternative medicine (CAM) use will be more likely to experience benefits of Qigong therapy     than those without such experience.   "
172847|NCT00104169|"     The purpose of this trial is to examine whether Epoetin Alfa, a hormone stimulating     production of red blood cells, can reverse idiopathic anemia.   "
172848|NCT00104182|"     This trial is conducted in Europe and the United States of America (USA). The aim of this     trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin     once a day (evening) when added to treatment with oral antidiabetic drugs in patients with     Type 2 diabetes.   "
172849|NCT00104195|"     The purpose of this trial is to study how teens with and without an anxiety disorder make     decisions.      This is a brain imaging study using functional magnetic resonance imaging (fMRI) in     adolescents between the ages of 13 and 17.   "
172850|NCT00104234|"     The purpose of this study is to evaluate the long-term efficacy and safety of rhASB treatment     in patients with Mucopolysaccharidosis VI.   "
172851|NCT00104247|"     The primary objective of this study is to evaluate the efficacy of Phenoptin™ (sapropterin     dihydrochloride) in reducing blood phenylalanine (Phe) levels in subjects with     phenylketonuria.   "
172852|NCT00104260|"     The primary objective is to evaluate the degree and frequency of response to Phenoptin™     (sapropterin dihydrochloride), as demonstrated by a reduction in blood phenylalanine (Phe)     level among subjects with phenylketonuria (PKU) who have elevated Phe levels. A secondary     objective of this study is to evaluate the safety of Phenoptin™ treatment in this subject     population, and identify individuals in this subject population who respond to Phenoptin™     treatment with a reduction in blood Phe level.   "
172853|NCT00104273|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose     levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's     Disease who are taking Aricept.   "
172854|NCT00104286|"     This is a phase I, single-arm, open-label, single-center study to establish the recommended     infusion schedule for Troxatyl™ administered as a continuous infusion for 2-5 days to     subjects with solid tumors.   "
172855|NCT00104299|"     Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of     small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's     granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used     to treat certain types of cancer. The purpose of this study is to determine the effectiveness     of rituximab in treating patients with WG and MPA.      Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce     disease remission by Month 6.   "
172856|NCT00104312|"     The purpose of this study is to understand the factors that lead to muscle weakness with     arthritis and aging.   "
172870|NCT00104507|"     This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c     receptor agonist, in clinical development as a potential treatment for obesity.      The purpose of this study is to obtain preliminary assessment of the safety and efficacy of     APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.   "
172871|NCT00104520|"     The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation     solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas     aeruginosa (PA).   "
172872|NCT00104533|"     Static magnetic therapy is increasingly used to alleviate pain; however, its efficacy has not     been determined yet.      The aims of this proposal are to evaluate the effect of magnetic therapy on pain intensity     levels, opioid requirements, and opioid side effects.   "
172857|NCT00104325|"     Background:      - National Institute on Aging researchers are looking at studies that require large numbers     of white blood cells for lab use. Standard blood samples do not provide enough white blood     cells for these studies. Researchers want to use cytapheresis to collect white blood cells     from volunteer donors. This procedure can collect larger amounts of white blood cells and     reduce the amount of fluid and other cells that are lost.      Objectives:      - To use cytapheresis to collect white blood cells for study.      Eligibility:      - Healthy blood donors at least 18 years of age.      Design:        -  Participants will be screened according to the usual blood donation procedures.        -  Participants will provide white blood cells through cytapheresis. The blood cells will          be collected in a machine that separates the white blood cells from the rest of the          blood. The rest of the blood will be returned to the donor.        -  Participants may have this type of donation every 56 days (six times per year). They          will be asked to become a repeat donor. A donation schedule may be set up.        -  Once a year, participants will have blood tests to continue to be eligible as a donor.   "
172858|NCT00104338|"     The purpose of this study is to assess the safety and effectiveness of a new oral     immunosuppressant agent compared to standard care in renal transplant patients diagnosed with     BK nephropathy.   "
172859|NCT00104364|"     The purpose of this trial is to study MK0731 in patients with recurrent or non-responsive     solid tumors, or cancers for which standard therapy does not exist.      This is an early phase trial and some specific protocol information is proprietary and not     publicly available at this time. (Full information is available to trial participants).   "
172860|NCT00104377|"     Grass MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide     pre-seasonal specific immunotherapy for patients with hypersensitivity to grass and rye     pollen. Different doses of Grass MATA will be administered and immunological changes     following this treatment will be assessed.   "
172861|NCT00104390|"     The purpose of this study is to evaluate the residual allergenicity of Grass MATA (modified     pollen allergen tyrosine adsorbate) by skin prick testing. This is done by a comparison of     the wheal response after skin prick testing with aqueous native and modified allergen,     modified tyrosine adsorbed allergen and Grass MATA MPL (modified tyrosine adsorbed + MPL).   "
172894|NCT00104819|"     RATIONALE: Vaccines made from a person's cancer cells may make the body build an effective     immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may     increase the number of immune cells found in bone marrow or peripheral blood and may     stimulate the immune system in different ways and stop cancer cells from growing.      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF     works in treating patients with progressive B-cell non-Hodgkin's lymphoma.   "
172862|NCT00104403|"     This study was designed to assess the safety and efficacy of different dosages and     administration schedules of an investigational agent administered over 3 days when added to     standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer     patients. Subjects will be asked to complete daily diaries while on study medication. In     addition subjects will be required to return to the investigational site several times during     the course of the study for follow up safety assessments which may include blood samples for     hematology and chemistry evaluations as well as physical exams. A final assessment will be     preformed on study Day 20-30 at which time the subject will complete the study.   "
172863|NCT00104416|"     This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine)     extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC)     seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like     LAMICTAL extended-release tablets but do not contain active medication. In this study,     LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.   "
172864|NCT00104429|"     This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in     combination with Combivir in HIV infected, untreated subjects.   "
172865|NCT00104442|"     Alzheimer's disease is a medical illness that damages the brain and causes problems with     memory, mood and behavior. A substance called acetylcholine (ACh), which is naturally     produced in the body, plays an important role in the normal functioning of the brain. In     subjects with Alzheimer's disease, the level of ACh is greatly reduced. Currently, there are     three commonly prescribed drugs used for treating the symptoms of Alzheimer's disease by     helping to maintain the level of ACh in the brain. This study will evaluate how much each of     these drugs changes the levels of certain brain chemicals that are known to, or may play an     important role in, Alzheimer's disease and its symptoms.   "
172866|NCT00104455|"     This trial is conducted in the United States of America (USA). The purpose of this trial is     to investigate the dose response to recombinant factor VIIa in healthy volunteers when     administered for bleed.   "
172867|NCT00104468|"     This is a phase I, single-arm, open-label, multi-center study of rising doses of Troxatyl™     whose purpose is to determine the safety, tolerance, and pharmacokinetics, and to establish     the recommended infusion schedule of Troxatyl™.   "
172868|NCT00104481|"     The purpose of this study is to evaluate the effectiveness of group therapy for cigarette     smoking cessation. The group meets for 8 sessions and includes education and group discussion     about the effects of smoking and ways to cope with withdrawal symptoms and other challenges     to maintaining abstinence. In one condition, the groups also learn techniques based on     cognitive therapy, to help cope with negative feelings.   "
172869|NCT00104494|"     Zinc deficiency has occasionally been reported in CF, but the need for additional zinc is     unclear. We will examine the effect of additional zinc supplements on zinc absorption, zinc     excretion, zinc balance and zinc kinetics in children with CF. Twelve children with CF will     receive additional zinc, and twelve will not. We will also compare the children with CF to 12     healthy children without CF. We hypothesize that children with CF will have poor zinc     absorption and high zinc excretion, leading to poor zinc balance and abnormal zinc kinetics.     We hypothesize that those children with CF who are given zinc supplements will have higher     zinc balance and more normal zinc kinetics than those without supplementation, and that zinc     balance and zinc kinetics will be similar to healthy children.   "
172873|NCT00104546|"     The purpose of this study is to test the feasibility and effectiveness of vitamin K     injections into certain body parts for the treatment of painful menstruation.   "
172874|NCT00104559|"     The purpose of this study is to test an interactive multimedia informed consent (iMIC)     computer program to see if the program can generate a consent form that potential     participants in an HIV trial can understand. This study will also determine if these     participants prefer the computer-generated consent form and associated interactive tools to a     standard consent form written by researchers.      Study hypothesis: 1) Participants who receive information about clinical trials from iMIC     Consent Tutorials will answer more questions about the trial correctly than participants who     receive information about clinical trials from standard paper consent forms. 2) Participants     will rate the iMIC Consent Tutorials as having better usability and user satisfaction than     standard paper consent forms.   "
172875|NCT00104572|"     Background: Men≥65 years often produce lower levels of testosterone, meaning there is less     testosterone circulating to the tissues of the body. This is associated with negative effects     on muscle strength, bone density, sexual function, mood, and the ability to think to the best     of one's ability. Testosterone replacement therapy often involves injections, patches, or     gels that help to raise circulating testosterone levels, but these therapies often have side     effects because they lead to imbalance of other hormones. Researchers have been studying the     effectiveness of anastrozole, a drug that can lower estrogen levels while simultaneously     increasing testosterone levels, as a treatment for the negative effects of decreased     circulating testosterone levels that occur naturally with aging. Objectives: To evaluate     whether anastrozole is as effective as testosterone gel in improving bone and muscle     strength, hormone levels, and brain function in men over 65 years of age. Eligibility:     Healthy men at least 65 years of age who have low levels of testosterone. Design: The study     involves six study visits over a total of 12 months: screening, baseline, 6 weeks, 3 months,     6 months, and 12 months. All participants will receive calcium and vitamin D supplements to     take daily, and will be randomized to one of three groups:Testosterone gel and placebo     tablet, Anastrozole tablet and placebo gel, Placebo tablet and gel. Participants will have     the following tests at each specified visit:Screening: Blood tests and rectal ultrasound to     evaluate the prostate;Baseline: Blood and urine tests; growth hormone levels, muscle     strength, bone density, and balance evaluation; imaging studies; cognitive testing; and     questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six     weeks: Blood tests and dose adjustment of the gel or tablet;Three months: Blood and urine     tests; growth hormone, muscle strength, bone density, and balance evaluation; and     questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six     months: Blood and urine tests; muscle strength, bone density, and balance evaluation;     cognitive testing; and questionnaires on quality of life, sexual function, depression, and     urinary symptoms;Twelve months: Blood and urine tests; rectal ultrasound; muscle strength,     bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires     on quality of life, sexual function, depression, and urinary symptoms.   "
172878|NCT00104611|"     This trial will test the safety and efficacy of a rTMS device for the treatment of major     depressive disorder (MDD). It is hypothesized that rTMS will have an antidepressant effect.      It is a 10-week, randomized, sham-controlled, multicenter trial in outpatients recruited in     both academic and private research centers. It is comprised of three major phases: pre-study     screening, acute treatment, and post-treatment taper. Eligible patients will be randomized to     one of two rTMS treatment groups. One group will receive active rTMS treatment and one will     receive an inactive, or sham, treatment. Each treatment takes about 45 minutes and is done on     an outpatient basis. All trial related medical care is provided at no cost to the     participant.   "
172879|NCT00104624|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well docetaxel works in treating older women     with metastatic breast cancer and whether it helps improve the ability to perform daily     activities.   "
172880|NCT00104637|"     The purpose of this study is to determine if sildenafil improves the exercise capacity and     lung function of patients with chronic obstructive pulmonary disease.   "
172881|NCT00104650|"     The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary     N-telopeptide in advanced cancer subjects with bone metastases.   "
172882|NCT00104663|"     PRION-1 aims to assess the activity and safety of Quinacrine (Mepacrine hydrochloride) in     human prion disease. It also aims to establish an appropriate framework for the clinical     assessment of therapeutic options for human prion disease that can be refined or expanded in     the future, as new agents become available.   "
172883|NCT00104676|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy     regimens to see how well they work in treating patients with stage II or stage III     non-seminomatous germ cell tumors.   "
172884|NCT00104689|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing.      PURPOSE: This phase II trial is studying how well giving capecitabine together with     oxaliplatin works in treating older patients with metastatic colorectal cancer.   "
172885|NCT00104702|"     RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation     therapy after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well radiation therapy works in treating older     women who are undergoing surgery for stage I or stage II breast cancer.   "
172886|NCT00104715|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin,     may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may     be an effective treatment for prostate cancer. It is not yet known whether giving hormone     therapy together with docetaxel is more effective than hormone therapy alone in treating     prostate cancer.      PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how     well they work compared to hormone therapy alone in treating patients with metastatic     prostate cancer.   "
172887|NCT00104728|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving gefitinib before surgery may shrink the tumor so it can be     removed.      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients who     are undergoing surgery for stage I, stage II, or stage III non-small cell lung cancer.   "
172888|NCT00104741|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as     triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation     therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide     together with radiation therapy may be an effective treatment for prostate cancer. It is not     yet known whether giving triptorelin and flutamide together with external-beam radiation     therapy is more effective than external-beam radiation therapy alone in treating prostate     cancer.      PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and     external-beam radiation therapy to see how well they work compared to external-beam radiation     therapy alone in treating patients with stage II or stage III prostate cancer.   "
172889|NCT00104754|"     RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.      PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients     with small cell lung cancer.   "
172890|NCT00104767|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It may also stimulate the immune system in different ways and stop     tumor cells from growing.      PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib in     treating patients with stage IIIB or stage IV non-small cell lung cancer.   "
172891|NCT00104780|"     RATIONALE: Vaccines made from peptides may make the body build an effective immune response     to kill tumor cells.      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients     with stage IIIB, stage IV, or recurrent non-small cell lung cancer.   "
172892|NCT00104793|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving irinotecan together with carboplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin     works in treating patients with newly diagnosed extensive-stage small cell lung cancer.   "
172893|NCT00104806|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Cholecalciferol (vitamin D) may help cancer cells become normal cells. Giving     arsenic trioxide together with cholecalciferol (vitamin D) may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with     cholecalciferol (vitamin D) works in treating patients with myelodysplastic syndromes.   "
172895|NCT00104845|"     RATIONALE: Vaccines made from DNA may make the body build an effective immune response to     kill tumor cells.      PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine     therapy in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.   "
172896|NCT00104858|"     This phase II trial studies how well fludarabine phosphate with radiation therapy and     rituximab followed by donor stem cell infusions work in treating patients with high-risk     chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with low side effects.     Nonmyeloablative stem cell transplants use low doses of chemotherapy (fludarabine phosphate)     and radiation to suppress the patient's immune system enough to prevent rejection of the     donor's stem cells. Following infusion of donor stem cells, a mixture of the patient's and     the donor's stem cells will exist and is called mixed chimerism. Donor cells will attack     the patient's leukemia. This is called the graft-versus-leukemia effect. Rituximab will be     given 3 days before and three times after infusing stem cells to help in controlling CLL     early after transplant till the graft-versus-leukemia takes control. Further, rituximab     could augment the graft-versus-leukemia effect by activating donor immune cells and hence     improve disease control. Sometimes the transplanted cells from a donor can also attack the     body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may     stop this from happening.   "
172897|NCT00104871|"     This phase II trial is studying how well bortezomib works in treating patients with     metastatic thyroid cancer that did not respond to radioactive iodine therapy. Bortezomib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth   "
172898|NCT00104884|"     RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with     unresectable stage III or stage IV malignant melanoma.   "
172899|NCT00104897|"     RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing.      PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin     works in treating patients with metastatic malignant melanoma.   "
172900|NCT00104910|"     This phase I trial is studying the side effects and best dose of cetuximab when given     together with cisplatin and radiation therapy in treating patients with stage IB, stage II,     stage III, or stage IVA cervical cancer. Monoclonal antibodies, such as cetuximab, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs     used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation     therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.     Giving cetuximab together with cisplatin and radiation therapy may kill more tumor cells.   "
172901|NCT00104923|"     RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Giving fenretinide in a different way may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of intravenous     fenretinide in treating patients with refractory or relapsed hematologic cancer.   "
172902|NCT00104936|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery may be     able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving     radiation therapy or radiosurgery after surgery may kill any remaining tumor cells. It is not     yet known whether radiation therapy or radiosurgery is more effective than observation alone     in treating benign meningioma.      PURPOSE: This randomized phase III trial is studying radiation therapy or radiosurgery to see     how well they work compared to observation alone in treating patients with newly diagnosed,     benign meningioma that has been partially removed by surgery.   "
172903|NCT00104949|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Trastuzumab may also stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.      PURPOSE: This phase II trial is studying how well trastuzumab works in treating patients with     locally advanced or metastatic synovial sarcoma.   "
172904|NCT00104962|"     This phase I trial is studying the side effects and best dose of lenalidomide in treating     young patients with relapsed or refractory solid tumors or myelodysplastic syndromes.     Lenalidomide may stop the growth of solid tumors or myelodysplastic syndromes by blocking     blood flow to the cancer. It may also stimulate the immune system in different ways and stop     cancer cells from growing.   "
172905|NCT00104975|"     RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell     transplant helps stop the growth of cancer cells. It also stops the patient's immune system     from rejecting the donor's stem cells. The donated stem cells may replace the patient's     immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving     an infusion of the donor's T cells that have been treated in the laboratory after the     transplant may help increase this effect. Sometimes the transplanted cells from a donor can     also make an immune response against the body's normal cells. Giving tacrolimus before and     after transplant may stop this from happening.      PURPOSE: This phase I trial is studying the side effects and best dose of donor lymphocytes     when given after alemtuzumab and combination chemotherapy in treating patients who are     undergoing donor stem cell transplant for hematologic cancer.   "
172906|NCT00104988|"     RATIONALE: Thalidomide may stop the growth of melanoma by blocking blood flow to the tumor.     It may also stimulate the immune system in different ways and stop tumor cells from growing.     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     thalidomide together with temozolomide may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving thalidomide together with     temozolomide works in treating patients with stage IV melanoma that cannot be removed by     surgery.   "
172907|NCT00105001|"     This randomized phase II trial studies how well giving tacrolimus and mycophenolate mofetil     (MMF) with or without sirolimus works in preventing acute graft-versus-host disease (GVHD) in     patients undergoing donor stem cell transplant for hematologic cancer. Giving low doses of     chemotherapy, such as fludarabine phosphate, and total-body-irradiation before a donor     peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune system and help destroy any remaining cancer cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving MMF and tacrolimus with or without     sirolimus after transplant may stop this from happening.   "
172908|NCT00105027|"     The SCORE Study will compare the effectiveness and safety of standard care to intravitreal     injection(s) of triamcinolone for treating macular edema (swelling of the central part of the     retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein     occlusion (BRVO).   "
172909|NCT00105040|"     A 12-week Evaluation Period will be used to characterize potential cognitive and     neuropsychological effects of LEV (20 - 60 mg/kg/day), as adjunctive treatment in children 4     - 16 years old, inclusive, with refractory partial onset seizures when compared to adjunctive     treatment with placebo.   "
172910|NCT00105053|"     This 2-phase study will determine the safety of treating patients with prostate cancer with     the genetically engineered HyperAcute-Prostate cancer vaccine. It will establish the proper     vaccine dose and will examine side effects and potential benefits of the treatment. The     vaccine contains killed prostate cancer cells containing a mouse gene that causes the     production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the     immune response to the foreign substance will stimulate the immune system to attack the     patient's own cancer cells that have similar proteins without this sugar pattern, causing the     tumor to remain stable or shrink.      Patients 19 years of age or older with hormone refractory prostate cancer that has recurred     or no longer responds to standard treatment may be eligible for this study. Candidates will     be screened with medical history and physical examination, blood tests, urinalysis, chest     x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if needed.      Participants will receive twelve vaccinations two weeks apart from each other. The vaccines     will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase     I of the study will treat successive groups of patients with increasing numbers of the     vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase     II will look for any beneficial effects of the vaccine given at the highest dose found to be     safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine     treatment. In addition, patient follow-up visits will be scheduled every 2 months for the     remaining first year (6 months) after vaccination and then every 3 months for the next 2     years for the following tests and procedures to evaluate treatment response and side effects:        -  Medical history and physical examination        -  Blood tests        -  X-rays and various scans (nuclear medicine/CT/MRI)        -  FACT-P Assessment questionnaire to measure the impact of treatment on the patient's          general well-being. The questionnaire is administered before beginning treatment,          monthly during treatment, and during follow-up visits after completing the treatment. It          includes questions on the severity of prostate cancer symptoms and the ability to          perform normal activities of daily life.   "
172911|NCT00105066|"     The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on     the blood vessels of individuals with the Metabolic Syndrome (MeS).   "
172912|NCT00105079|"     This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir     or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human     immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment.     Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice     daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir     400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study     treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
172913|NCT00105092|"     Enzastaurin given daily to patients with non-small cell lung cancer who have failed at least     one prior therapy.   "
172914|NCT00105105|"     The purpose of this study is to evaluate the effects of C-1073 (Mifepristone) on cognition in     patients with Alzheimer's disease (AD) who are also taking an acetylcholinesterase inhibitor     (Aricept, Exelon or Reminyl).   "
172915|NCT00105118|"     This study will examine the effect of transcranial magnetic stimulation (TMS) on short-term     memory in healthy adults. Healthy people use their brains to answer short-term memory     questions in a different way than do patients with schizophrenia. Attention and memory     deficits in schizophrenia patients significantly hamper their recovery and rehabilitation,     yet there are no effective treatments for these impairments. TMS is a method of brain     stimulation that may be able to change the electrical activity of the nerve cells of the     brain and improve certain brain functions. This study will explore the effect of TMS on     memory and perhaps discover brain processes that may be helpful in developing new ways to     treat schizophrenia.      Healthy volunteers between 18 and 55 years of age, excluding pregnant women, may be eligible     for this study. Participants undergo the following tests and procedures:        -  Medical history, physical examination, blood tests, electrocardiogram (EKG), and urine          pregnancy test for women of childbearing age.        -  Magnetic resonance imaging (MRI) and functional MRI (fMRI). These tests are done in          participants who have not had structural and functional MRIs as participants in NIMH's          2-day schizophrenia study within 90 days of entering the current study. MRI is done to          locate the place in the brain to simulate with TMS and fMRI is done to look at brain          activity while the subject solves short-term memory tasks. Both tests are done at the          same session. Before the scan, four vitamin E capsules are taped to the subject's scalp.          After the capsules are in place, the subject lies on a stretcher that is moved into the          scanner - a narrow cylinder with a strong magnetic field. During the scan, subjects are          asked to do some simple tests, such as watching pictures on a screen or pressing buttons          in response to numbers they were shown a few seconds earlier. Scanning may take up to 2          hours, but usually lasts between 45 and 90 minutes.        -  TMS. For this procedure, subjects receive either active TMS or a sham procedure          (placebo) that imitates TMS but does not use real electrical stimulation. For TMS, an          insulated wire coil is placed on the scalp and a brief electrical current is passed          through it. This generates magnetic pulses that travel through the scalp and skull and          cause small electrical currents in the cortex, or outer part of the brain. The          stimulation may cause muscle twitching in the scalp or face and may also cause small          movement of the limbs. During the procedure, electrodes are taped to the scalp to record          the electrical activity of the brain while short-term memory is tested. Two tests make          up a set. There are a total of six test sets; each set takes about 3 minutes. Five          periods of electrical stimulation are delivered before each test set. Each period of          stimulation lasts 5 seconds, followed by a 10-second rest period. The stimulation-rest          intervals continue until five periods of TMS have been applied. For the memory test,          subjects press a key on a computer keyboard as quickly and accurately as possible in a          test of their ability to remember a string of numbers, or letters.        -  Questionnaires. At the beginning and end of the TMS session, participants fill out          questionnaires that assess their mood, ability to concentrate, and level of anxiety.   "
172927|NCT00105287|"     The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl     when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.   "
172928|NCT00105300|"     The goal of this study is to test whether adalimumab can induce clinical remission in     subjects with active Crohn's disease who have been initially treated with infliximab and     either lost response or discontinued its use as a result of intolerance to the drug.   "
172941|NCT00105482|"     Weight gain after quitting smoking is an important barrier to treatment for many smokers.     This study will test a drug called naltrexone with weight-concerned smokers to investigate     whether or not this drug both improves smoking cessation quit rates and minimizes post quit     weight gain.   "
172916|NCT00105131|"     This study will explore the risks and causes of Parkinson's disease, a chronic progressive     nervous system disorder. Patients typically have tremors, muscle weakness and a shuffling     gait.      Patients with Parkinson's disease, their relatives and healthy volunteers may be eligible for     this study. Candidates must be 18 years of age or older. Patients whose parkinsonism is due     to a secondary cause, such as infection or injury, and healthy volunteers who have a first     degree family member (parent, grandparent, child, sibling) with Parkinson's disease are     excluded from enrollment.      Participants are asked about possible symptoms they may have and about their general health.     They provide a blood sample to obtain DNA for genetic analysis to look for genetic     differences that might be related to risks for Parkinson's disease. White blood cells may be     treated in the laboratory to grow a cell line, which provides a source of substances in the     blood without having to draw samples repeatedly.   "
172917|NCT00105144|"     The purpose of the study is to determine the safety and effectiveness of two dose levels of     micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.   "
172918|NCT00105157|"     This study will investigate the safety and efficacy of different doses of an investigational     drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral     therapies.   "
172919|NCT00105170|"     This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors.     This is the first study of hCBE-11 in humans and is designed to determine the safety and how     well patients tolerate this investigational drug. The study duration is two years with     treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and     long-term follow-up contact every 3 months thereafter.   "
172920|NCT00105183|"     The purpose of this study is to assess the efficacy and safety of the study drug, known as     ATG Fresenius S, which is sometimes called EZ-2053, to prevent a lung transplant     patient's body from rejecting a transplanted lung or lungs.   "
172921|NCT00105196|"     The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess     the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned     open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder     who demonstrate an incomplete response to a prospective eight week trial of the same assigned     open-label marketed antidepressant therapy.   "
172949|NCT00105586|"     This study will determine the efficacy of escitalopram (Lexapro®), an anti-anxiety drug, for     generalized anxiety disorder (GAD) and the ways genetics affect response to treatment for GAD     in elderly individuals.   "
172922|NCT00105209|"     Rationale: Idiopathic pulmonary arterial hypertension (IPAH) is characterized by in situ     thrombosis and increased thromboxane A2 (Tx-M) synthesis. While both may be attributable to     abnormal platelet function, there are no studies of anti-platelet therapy in IPAH.      Objectives: The purpose of this study is to assess the effects of aspirin (ASA) and     clopidogrel on platelet function and eicosanoid metabolism in patients with IPAH.   "
172923|NCT00105222|"     This study will examine how nitrite infusions affect exercise tolerance (how much a person     can exercise before having to stop). Exercise ability is limited by how fast oxygen can be     delivered to the body and how fast the body can produce energy. Both of these processes are     affected by nitric oxide (NO), a gas produced by cells that line blood vessels. NO is     important in regulating blood vessel dilation, and consequently, blood flow. Nitrite may act     as a storehouse for nitric oxide and be able to improve exercise tolerance.      Healthy normal volunteers between 21 and 45 years of age who can use an exercise bicycle may     be eligible for this study. Candidates are screened with a medical history, physical     examination, electrocardiogram, breathing tests, blood tests, and a pregnancy test for women     who are able to bear children. Pregnant women are excluded from the study. The screening     session includes practice exercise on the bicycle.      Participants exercise on a stationery exercise bicycle for about 30 minutes on each of two     study days. During the test, they breathe in and out of a mouthpiece that allows inhaled and     exhaled respiratory gases to be measured. Before subjects begin to exercise, a small tube is     placed in the artery of their forearm inside the elbow. A longer tube called a central line     is placed in a deeper vein in the neck after the area has been numbed. A thinner tube, called     a pulmonary artery catheter, is placed through the central line and advanced into the     chambers of the heart, through the heart valve, and into the lung artery. This catheter     measures various pressures directly in the heart and lungs. Blood samples are drawn through     the catheter also, to avoid the need for multiple needle sticks. Another tube is placed in     the vein of the other arm to deliver medications.      Thirty minutes after all the tubes are placed, a blood sample is drawn for baseline     measurements. Then, either saline (sterile salt water) or nitrite is injected into the tube     in the arm vein. Thirty minutes after the injection, the subject starts exercising on the     bicycle. The work setting on the bicycle is increased every minute, and the subject pedals     until he or she is too tired to continue. During the test, a small blood sample is collected     every 2 minutes. Heart rate, blood pressure, and heart rhythms are continuously monitored.      After the test on the first day, participants are admitted to the hospital to rest for the     remainder of the afternoon and evening. The tubes are kept in place for the following     morning, when the procedure is repeated exactly as before, except that subjects who received     saline the first day are given nitrite the second day, and vice versa.   "
172924|NCT00105235|"     Alemtuzumab is a man-made antibody used to treat certain blood disorders. Tacrolimus is a     drug used to decrease immune system activity in people who have received organ transplants so     that the new organ will not be rejected. This study will determine whether treatment with     alemtuzumab and tacrolimus is effective in preventing organ rejection and maintaining the     recipient's health after liver transplantation in patients with end-stage liver disease, and     whether gradual tapering of tacrolimus treatment is safe for these patients.   "
172925|NCT00105248|"     The purpose of this study is to evaluate the effectiveness of a short training program for     general practitioners in patient-centered communication to reduce antibiotic prescription for     acute respiratory tract infections (ARTI).   "
172926|NCT00105274|"     Velocardiofacial syndrome, also known as 22q11.2 syndrome or DiGeorge syndrome, has been     associated with many features such as a cleft palate, heart defects, and learning, speech and     feeding problems. It is caused by the absence of a number of genes on chromosome 22, but the     mechanism by which this inborn abnormality causes the clinical problems is not known.      In this study by the National Institute of Mental Health and the Office of Rare Diseases, we     are recruiting participants with 22q11.2 syndrome to come for a three-day stay to our main     campus in Bethesda, MD, to participate in a study in which we will investigate the genetic     makeup of their cells together with several studies of brain function with advanced research     imaging. The goal of this study is to understand how the genes missing in 22q11.2 syndrome     are related to the increased occurrence of psychiatric problems, such as psychosis, in this     syndrome. Participants must be 18-50 years of age, have some high school education and not     currently be taking antipsychotic medication. Travel costs to Bethesda for participants and     an accompanying person will be paid, and participants are reimbursed for their time in     participating in the study. A blood draw is required. All research procedures have been     designated as minimal risk procedures.   "
172929|NCT00105313|"     For primary objectives, we will determine the MTD and examine clinical responses and immune     cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507.      For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum     concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and     recovery of CD2 positive and total T-Cell populations.   "
172930|NCT00105326|"     The primary objective of this study is to evaluate the amelioration of the sleep architecture     of patients with schizophrenia and schizophrenia-related insomnia, treated with either 9 mg     of extended-release paliperidone ER or placebo, using polysomnography.   "
172931|NCT00105339|"     The main goal of this project is to develop and evaluate a simplified version of an HIV     vaccine trial consent form designed for high-risk adolescents. The process will include: (1)     reducing reading grade level by simplifying sentence structure and decreasing the use of     infrequently used words; (2) re-organizing and categorizing the material for improved flow;     and (3) developing a set of pictures to emphasize key concepts in the material. These     materials will be tested among small focus groups of high-risk adolescents. A pre-post test     design will be used to compare the simplified, adolescent-tailored consent form to one     currently used in the National Institute of Allergy and Infection Diseases (NIAID) Vaccine     Trial Information Booklet.   "
172950|NCT00105599|"     This study of the FairCare Program (FC) is designed to address end of life (EOL) care     delivery issues by reducing barriers to effective EOL care among health care providers,     family members, surrogates, and Chronic Heart Failure (CHF) patients using a comprehensive,     multi-pronged approach delivered by a care coordinator and supported by an interdisciplinary     team.   "
172951|NCT00105612|"     The purpose of this trial is to test whether a memory and organizational aid in the form of a     document that summarizes and simplifies a study's key points can improve the decision-making     abilities and competency of mild to early moderate Alzheimer's disease (AD) patients.   "
173022|NCT00098215|"     The purpose of this study is to determine whether a specialized, technology-based training     program in tobacco prevention is more effective than standard training for pediatric     residents who counsel youth and their parents.   "
172932|NCT00105352|"     OBJECTIVE:      This study is being conducted by the Type 1 Diabetes TrialNet Study Group, funded by the     National Institutes of Health, in collaboration with the European C-Peptide Group. The goal     is to evaluate comparability and reproducibility of measures of beta cell function in type 1     diabetes comparing the mixed meal tolerance tests (MMTT) and glucagon stimulation test (GST).     These two tests will be compared to assess the relationship between the MMTT and IV     (intravenous) Glucagon stimulated C-peptide responses as measured by time to peak C-peptide     and AUC (area under the curve) values.      Based on the understanding that type 1 diabetes results from an immune mediated loss of     pancreatic beta cells, therapeutic trials and newer measures of beta cell function can be     evaluated as endpoints for clinical trials. Direct assessment of residual beta cell function     is an appropriate endpoint, as retention of beta cell function in patients with T1D is known     to result in improved glycemic control and reduced hypoglycemia, retinopathy and nephropathy.     Endogenous beta cell function or insulin secretion is best measured by determination of     C-peptide (which is co-secreted with insulin in a 1:1 molar ratio). Intervention studies over     the past few decades have usually used measurement of C-peptide. However, the relationship     between these or other measures of beta cell function has not been well studied. The relative     advantages of one measure over another in terms of variability, sensitivity and burden to the     subject is unknown. In addition, the optimal conditions for the conduct of the test need to     be determined.      An important goal is to develop an international consensus about the conduct of metabolic     tests in the context of large, multicenter trials involving type 1 diabetes (T1D) by     balancing the scientific data with the burden on the subject.   "
172933|NCT00105365|"     This trial will assess the ability of shoe inserts to relieve pain and disability in people     with knee osteoarthritis (OA) in the inner (medial) aspect of the knee.   "
172934|NCT00105378|"     The purpose of this study is to study the effects of nursing home visits in independently     living elderly people on their functional performance and health-related quality of life. The     general practitioner (GP) can refer elderly people to this intervention model after     identification of a problem in cognition, mood, behavior, mobility, or nutrition. A     specialist geriatric nurse visits the patients at home up to six times and coaches the     patient in cooperation with the GP and geriatrician.   "
172935|NCT00105404|"     This study will compare the side effects of two treatments for diabetic macular edema, in     which blood vessels in the retina (tissue that lines the back of the eye) become leaky and     the retina and macula (the center part of the retina that is responsible for fine vision)     swell, causing vision loss.      Patients 18 years of age and older with diabetes mellitus and macular edema in one or both     eyes may be eligible for this study. Candidates are screened with the following tests and     procedures:        -  Blood pressure measurement.        -  Blood tests to measure HbA1c, a measure of the patient's diabetes control.        -  Eye examination to assess visual acuity and eye pressure, and to examine pupils, lens,          retina and eye movements. The pupils are dilated with drops for this examination.        -  Eye photography to help evaluate the status of the retina and changes that may occur in          the future. Photographs of the inside of the eye are taken using a camera that flashes a          bright light into the eye.        -  Electroretinograms (ERG) to measure electrical responses generated in the retina.          Wearing eye patches, the patient sits in a dark room for 30 minutes. Then, electrodes          are taped to the forehead and an earlobe. The eye patches are removed, the surface of          the eye is numbed with eye drops, and contact lenses are placed on the eyes. The patient          looks inside a white globe that emits a series of light flashes for about 20 minutes.          The contact lenses sense small electrical signals generated by the retina when the light          flashes.        -  Optical coherence tomography to measure retinal thickness. The eye is examined with a          machine that produces cross-sectional pictures of the retina. These measurements are          repeated during the study to determine whether retinal thickening is improving,          worsening, or staying the same.      Patients with macular edema in both eyes receive laser therapy in one eye and triamcinolone     injections in the other. Patients with just one affected eye are randomly assigned to receive     either laser or triamcinolone treatment. Those who receive only laser therapy may later     receive triamcinolone injections in the second eye if it, too, develops macular edema.      For the laser treatment, the eye surface is numbed with drops and a contact lens is placed on     the eye during the laser beam application. Before the treatment, patients may have     fluorescein angiography, in which pictures of the retina are taken using a yellow dye. The     dye is injected into a vein and travels to the blood vessels in the eye. The camera flashes a     blue light in the eye and takes pictures that show the amount of dye leakage into the retina.     This helps guide the laser treatment. Patients return for follow-up visits every 4 months for     3 years. If the macular edema is gone, no additional treatment is given and patients are     followed as often as every 2 months. If the edema does return, additional treatments may be     done at subsequent visits. Patients whose vision worsens considerably at the end of 1 year     may be treated with a steroid injection, unless the other eye has also been treated with     triamcinolone.      For the triamcinolone injections, numbing drops, antibiotic drops, and drops to dilate the     pupil, and possibly and anesthetic injection, are put in the eye before the medicine is     injected into the vitreous (jelly-like substance inside the eye). Then, the patient lies on     his or her back for 30 minutes before being discharged home. Patients return for follow-up     visits 4 days and 4 weeks after the injection, and then every 4 months for 3 years. Patients     whose edema resolves are followed as often as every 2 months. Those whose edema returns have     additional injections at the 4-month visits. Patients whose condition does not improve after     1 year or whose vision worsens may undergo laser treatment.   "
172936|NCT00105417|"     This study will evaluate whether interleukin-7 (IL-7) a drug similar to the natural IL-7     protein produced by the body, is safe to use in people infected with HIV. IL-7 is important     in immune system function. In humans, it can extend the life of immune cells called T-cells     and increase their function and maturation; in mice, it can speed up immune system recovery     following chemotherapy of transplantation; and in monkeys, it can make T-cells increase in     numbers. If this study shows that IL-7 is safe, other trials will determine if it can improve     the numbers or function of T-cells in HIV-infected people.      Patients 18 years of age and older with HIV infection who have been taking anti-HIV     medications for at least 12 months, whose CD4 counts are at least 100 cells/microliter, and     whose viral load is no more than 50,000 copies/milliliter may be eligible for this study.     Candidates are screened with a physical examination, blood and urine tests, including a blood     test for HLA type (a genetic test of markers of the immune system), chest x-ray,     electrocardiogram, and ultrasound of the spleen.      Participants undergo the following tests and procedures during 9 visits, as follows:      Pre-entry visit        -  Brief physical examination, including examination of lymph nodes and spleen.        -  Medical history, including questions about current and past medications.        -  Urine pregnancy test for women who are able to become pregnant.        -  Blood draw for viral load, immune responses, and other routine safety tests.      Entry visit        -  Complete physical examination, including examination of lymph nodes and spleen.        -  Routine urine test and urine pregnancy test for women who are able to become pregnant.        -  Blood draw for viral load, immune responses, and other routine safety tests.        -  IL-7 dosing. Participants are randomly assigned to receive one of five doses of IL-7 (3,          10, 30, 60 or 100 micrograms per kilogram of body weight) or placebo (a salt solution          that does not contain IL-7). The dose may be given in one or more injections, with          higher doses possibly requiring as many as seven or eight injections. The injections are          given subcutaneously (under the skin), usually in the arm or leg. After the injection,          patients are monitored closely for 12 hours for skin or allergic reactions. Blood is          drawn before the injection and again at 0.5, 1, 1.5, 2, 2.5, 4, 8 and 12 hours after the          injection to check blood levels of the study medication.      Follow-up visits      Patients come to the clinic 7 times during follow-up-every day for the first 4 days after the     injection, then at 14 days, 4 weeks, and 8 weeks after the injection. At most study visits,     patients have the following procedures:        -  Brief physical examination, including examination of lymph nodes and spleen.        -  Routine urine test and urine pregnancy test for women who are able to become pregnant.        -  Blood draw for viral load, immune responses, and other routine safety tests.        -  Blood test to measure the amount of study medication in the blood 1, 2, and 3 days after          the injection        -  Electrocardiogram 1 day after the injection   "
172937|NCT00105430|"     This study will evaluate the effectiveness of deep brain stimulation (DBS) in treating     primary generalized dystonia. Patients with dystonia have muscle spasms that cause     uncontrolled twisting and repetitive movement or abnormal postures. Medical therapies are     available, but not all patients get adequate relief from the abnormal movements or the pain     associated with them. DBS is a surgical procedure that interrupts neuronal circuits in the     Gpi and STN, areas of the basal ganglia of the brain that do not work correctly in patients     with dystonia. The surgery results in decreased movement and therefore may lessen patients'     symptoms and pain.      Patients 7 years of age and older with generalized dystonia that does not respond to medical     treatment may be eligible for this study. Candidates are screened with blood and urine tests,     chest x-ray, and an electrocardiogram in patients 35 years of age or more.      Participants undergo the following tests and procedures:        -  Magnetic resonance imaging. MRI uses a magnetic field and radio waves to produce images          of the brain. The patient lies on a table that is moved into the scanner (a narrow          cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur          during the scanning process. The procedure usually lasts about 45 to 90 minutes, during          which the patient is asked to lie still for up to 15 minutes at a time.        -  Transcranial magnetic stimulation. This procedure maps brain function. A wire coil is          held on the scalp, and a brief electrical current is passed through the coil, creating a          magnetic pulse that stimulates the brain. During the stimulation, the patient may be          asked to tense certain muscles slightly or perform other simple actions. The stimulation          may cause a twitch in muscles of the face, arm, or leg, and the patient may hear a click          and feel a pulling sensation on the skin under the coil. During the stimulation,          electrical activity of muscles is recorded with a computer, using electrodes attached to          the skin with tape.        -  Neurologic evaluation. Before and after DBS, the patient's dystonia, including voice          strength and difficulty swallowing, are measured with a standardized rating scale.        -  DBS treatment. Patients are randomly assigned to have electrodes implanted in either the          Gpi or STN area of the basal ganglia. The electrodes are what stimulate the brain in DBS          therapy. Before surgery, a frame is secured to the patient's head, and an MRI scan is          done. DBS involves making two small incisions and two small holes in the skull, opening          the lining around the brain, locating the Gpi or STN, securing the electrodes in place          and connecting them to the pulse generator that is placed under the skin below the          collar bone. Additionally, during the surgery, the patient is asked to move certain          muscles. The muscle activity is recorded to gain a better understanding of the          physiology of movement. After surgery, computed tomography (CT) and MRI scans are done          to confirm placement of the electrodes.        -  Stimulation and evaluation. After surgery, patients' movements are evaluated during and          after stimulation. The changes in movement and function are videotaped and scored          according to a rating scale. The optimal stimulation settings are determined and the          stimulators are adjusted accordingly.        -  Follow-up. Patients are evaluated, with videotaping, at 1, 2, 3, 6, 12, 18 and 24 months          after surgery, and the stimulators are adjusted as needed.   "
172938|NCT00105443|"     The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find     out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents     the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics     (PK) in patients with liver cancer.   "
172939|NCT00105456|"     This is a prospective observational cohort study designed to describe effectiveness and     safety (treatment outcomes and clinically significant cardiac adverse events, respectively)     in patients with HER2-positive metastatic breast cancer.   "
172940|NCT00105469|"     The purpose of this study is to evaluate the clinical and microbial efficacy and safety of     AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of     age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will     be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required     for the study.   "
172945|NCT00105534|"     The purpose of this study is to evaluate the clinical and microbial efficacy and safety of     AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age     and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be     randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required     for this study.   "
172946|NCT00105547|"     The purpose of the study is to evaluate the change in cognitive ability and activities of     daily living in patients with Alzheimer's disease (AD) as measured by specific evaluations     during 18 months of dosing.   "
172947|NCT00105560|"     RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a     tumor was surgically removed may kill any remaining tumor cells and cause less damage to     normal tissue.      PURPOSE: This phase II trial is studying how well proton beam radiation therapy works in     treating young patients who have undergone biopsy or surgery for medulloblastoma or     pineoblastoma.   "
172948|NCT00105573|"     This study will compare three interventions for depressed, low income mothers and determine     which is most effective in treating maternal depression and in fostering development in     infants.   "
172952|NCT00105625|"     Hospital-acquired infections can occur five times as frequently in rehabilitation patients     than in other hospital admissions. We postulate that this high infection rate may be due to     nutritional problems frequently experienced in these patients. In this study, we examine the     role of nutrition in inpatient geriatric rehabilitation patients' immune function and     infection rates.   "
172953|NCT00105638|"     This study was designed to evaluate the impact of a Telehealth Education Program (TEP) on     outpatient veterans with moderate to severe dementia and their spouse caregivers. The TEP is     a program of education, coping skills, problem solving and support presented to caregivers of     veterans with dementia by teleconference in 10 weekly, one-hour sessions. The TEP was based     on a stress and coping model aimed to enhance the knowledge, skills and feelings of support     of the caregivers who participated.   "
172954|NCT00105651|"     Data from the Surveillance, Epidemiology and End Results (SEER) cancer registry indicates     that head and neck cancers (HN Ca) are nearly twice as common in veterans as non-veterans. HN     Ca patients are at an increased risk for smoking, alcohol consumption and depression, all of     which contribute to a further decline in their quality of life (QoL). In the HN Ca     population, diagnosis and treatment of smoking, alcohol intake and depression are     sub-optimal, thereby affecting QoL and survival. Numerous studies have documented that     smoking, alcohol and depression are interrelated and research on multi-modal interventions     has been suggested.   "
172955|NCT00105664|"     Data from VA-funded studies and the broader literature indicate that chronic stable angina     (CSA) is prevalent, under recognized, under treated and associated with reduced quality of     life. There are substantial opportunities for improving care of patients with this     debilitating and potentially fatal problem. Because primary care providers manage most     patients with CSA, efforts to improve care must necessarily involve the primary care delivery     system. C3P is composed of a set of interventions employing a Collaborative Care Team model,     which has been shown to be effective in managing other chronic illnesses in the primary care     setting.   "
172956|NCT00105677|"     The purpose of this study is to examine cultural and clinical context factors in     African-American and white veterans with knee or hip osteoarthritis with a focus on how these     factors may be potentially modifiable determinants of willingness to consider joint     replacement.   "
172957|NCT00105690|"     We adapted the collaborative care model using telemedicine (e.g., telephone, interactive     video, electronic medical records) to support antidepressant therapy initiated by primary     care providers in small rural practices and evaluated the effectiveness and     cost-effectiveness of telemedicine-based collaborative care.   "
172958|NCT00105703|"     Despite established clinical practice guidelines, wide variations exist in the care of     chronic heart failure (CHF) patients in Veterans Health Administration. Previous randomized,     controlled studies have suggested that a nurse case management model may improve the outcomes     of care for patients with CHF. However, these studies involved selected groups of patients     (i.e., those who agreed to participate in randomized trials) in selected settings (i.e.,     tertiary care facilities); so, the findings are not likely to be indicative of the true     effectiveness of case management in a large population of CHF patients.   "
172959|NCT00105716|"     This four and a half year trial is evaluating both a patient and a provider intervention in a     primary care setting among diagnosed hypertensive veterans. The two primary hypotheses are:     1) the proportion of veterans with BP control who receive either the provider-directed     decision support or the patient health education and behavioral intervention will be     increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control     who receive both the provider-directed decision support and the patient health education and     behavioral intervention will be increased by 25% as compared to usual care.   "
172960|NCT00105729|"     Self-help groups (SHGs) have become an important component of the system of care for patients     with substance use disorders (SUDs). SUD patients' participation in SHGs has been linked to     lower relapse rates and less use of additional treatment services.   "
172961|NCT00105742|"     Hearing impairment is one of the most common disabilities in veterans. The decreased ability     to communicate is troubling in itself, but the strong association of hearing loss with     functional decline and depression adds further to the burden on the hearing-impaired.     Although hearing amplification improves quality of life, hearing evaluations are offered     infrequently to older patients. Only 25 percent of patients with aidable hearing loss receive     treatment. Up to 30 percent of patients who receive hearing aids do not use them. We contend     that an effective formal screening program should identify hearing-impaired patients who are     motivated to seek evaluation and who derive benefit from treatment.   "
172962|NCT00105755|"     Foot ulcers remain the most common reason for hospital admission among veterans with     diabetes. Healing and preventing these wounds should be a high priority for clinicians     treating these high-risk patients. Previous work by the investigators has suggested that     diabetic foot ulcers are preceded by inflammation, which can potentially be detected with a     thermometer.   "
173309|NCT00110565|"     The purpose of this study is to determine whether a pulsed magnetic field (PMF) pad will     improve symptoms of rheumatoid arthritis (RA) in postmenopausal women.      Study hypothesis: A pulsed magnetic field pad will effectively reduce the symptoms of RA in     postmenopausal women.   "
172963|NCT00105768|"     VA investigators have described greater substance use at the beginning of the month when     disability and other monthly checks are received. The proposed research addresses an     important VA priority�seeing that veterans� funds are spent to improve veterans� quality of     life and are not misspent on substances of abuse.   "
172964|NCT00105781|"     Aging veterans with functional impairments followed in primary care clinics were randomized     to counseling for a walking plus strength exercise home-based exercise program or to health     education by a nurse. Exercise participants attended 3 intervention sessions totaling about     100 minutes of contact with the nurse and a physical therapy assistant over 10 months. They     were also asked to record walking and strength exercise on monthly calendars and received     motivational automated phone messages. Education control patients discussed health topics of     their choice with the nurse. Materials were based on National Institute of Aging materials     currently available on the internet. After 10 months, the exercise participants reported more     time spent in walking and strength exercise and accelerometer data indicated a greater     increase in time spent in moderate or higher intensity activity per day. Participants who     engaged in strength exercises improved more on functional fitness tests and quality of life     after 10 months. Analyses from the cognitive sub-study remain incomplete.   "
173023|NCT00098228|"     The trial is designed to identify an appropriate dose of QAB149 for delivery via a multiple     dose inhaler for use in the COPD Phase III program.   "
172965|NCT00105794|"     During a psychiatric crisis, persons with severe mental illness (SMI) confront complex     challenges concerning treatment choices and are often ill equipped or unable to make mental     health care decisions. Psychiatric Advance Directives (PADs) are legal documents that allow     competent persons to declare their treatment preferences in advance of a mental health     crisis, when they may lose capacity to make reliable health care decisions. The use of PADs     is consistent with recommendations of the President�s New Freedom Commission on Mental     Illness and the Patient Self-Determination Act; 25 states have now adopted PAD legislation.     VA does not have a specific policy for PADs or mechanisms to notify veterans of their right     to prepare PADs. The downstream effects of PADs on patient care, crisis management, service     use, and clinical outcomes are unknown.   "
172966|NCT00105807|"     Veterans are admitted to Veterans Health Administration (VA) Nursing Homes (NH) because     impairment in their ability to perform activities of daily living (ADL) overwhelms their     support system (family/friends) in the community. The etiologies of this impairment are, in     part, due to chronic disease, deconditioning, and immobility. Yet, after admission, NH     residents frequently have decreased levels of daily activity compared with their preadmission     activity. Our preliminary observations suggest that dependent, frail residents improve in     function in response to exercise in a NH setting.   "
172967|NCT00105820|"     In spite of the impact on veteran�s health status and treatment cost, depression is     under-diagnosed and under-treated. The goal of this study is to learn how to implement a     previously tested, effective collaborative care model for improving the quality of depression     care across multiple Veterans Integrated Service Networks (VISNs). To achieve this goal, we     are conducting a randomized controlled trial of evidence-based quality improvement (EBQI), a     dissemination method that relies on expert design and local implementation of evidence-based     practice interventions. We hypothesize that EBQI will result in increased rates of assessment     and appropriate management of depression. Results will be useful in designing realistic     chronic care programs and performance measures for continuing care improvement.   "
172968|NCT00105833|"     Depression is common in primary care settings, and associated with substantial physical and     psychosocial impairment and increased healthcare utilization. Despite efforts to educate     primary care providers, depression is often undetected or undertreated in primary care     settings. The main objective of this study was to determine the impact of a low-intensity,     care management intervention on depression treatment outcomes of patients in a VA primary     care setting.   "
172969|NCT00105846|"     Tele-home health care, which providers for video interactions between home-based veterans and     home care nurses, is a potentially useful adjunct to home care services. However, few     randomized trials have been conducted of this technology.   "
172970|NCT00105859|"     Pressure ulcers are a serious, costly, and life-long complication of spinal cord injury     (SCI). Pressure ulcer prevalence has been estimated at between 17 and 33% among persons with     SCI residing in the community. Epidemiological studies have found that 36-50% of all persons     with SCI who develop pressure ulcers will develop a recurrence within the first year after     initial healing (Carlson et al., 1992; Fuhrer et al., 1993; Goldstein, 1998; Niazi et al.,     1997; Salzberg et al. 1998). Recurrence rates have ranged from 21% to 79%, regardless of     treatment (Schryvers et al., 2000; Goodman et al., 1999; Niazi et al., 1997). Pressure ulcer     treatment is expensive. Surgical costs associated with pressure ulcer treatment can exceed     $70,000 per case (Braun et al., 1992). VA administrative (National Patient Care Database,     NPCD) data indicate that 41% of inpatient days in the SCI population are accounted for by     either primary or secondary diagnoses of pressure ulcers or 23% of SCI inpatient days if     restricted to primary diagnoses of pressure ulcers. Pressure ulcer recurrence has been     associated with many factors including previous pressure ulcer surgery (Niazi et al., 1997).     Although little data exist describing the factors associated with recurrence following     surgery, some investigators reported recurrence rates of 11%-29% in cases with post-operative     complications and 6% to 61% in cases without post-operative complications (Mandrekas &     Mastorakos, 1992; Relander & Palmer, 1988; Disa et al., 1992). In a retrospective study of 48     veterans with SCI, investigators reported a 79% recurrence rate following surgery (Goodman et     al., 1999).   "
172971|NCT00105872|"     Insomnia reduces quality of life, increases risks for other illnesses, and enhances health     care costs/utilization. Several efficacy studies have shown that Cognitive-Behavioral Therapy     (CBT) for insomnia improves sleep and diurnal complaints among highly screened samples;     however, its effectiveness among �real-world� primary care patients is yet to be tested. This     project is highly relevant to the VA health care mission, given the high prevalence of     insomnia in middle-aged and older adults. Pilot data from this VA suggest that 40% of primary     care patients report trouble sleeping.   "
173411|NCT00103571|"     The purposes of this study are to assess similarities and differences in the efficacy (how     well the drug works), safety, and side effects of olanzapine and aripiprazole in patients     with schizophrenia, schizoaffective disorder, or schizophreniform disorder.   "
172972|NCT00105885|"     The purpose of this study is to answer the following questions: (1) Does substituting brief,     scheduled, clinician-initiated telephone calls (telephone care) for routine psychiatric     medication management visits reduce overall healthcare utilization? (2) Is substituting     brief, scheduled, clinician-initiated telephone calls (telephone care) for routine     psychiatric medication management visits as effective as routine care?   "
172973|NCT00105898|"     This study is comparing the effectiveness of web-based care management to either     telephone-based care management or internet access alone, in patients with poorly controlled     diabetes mellitus.   "
172974|NCT00105911|"     The literature and our preliminary studies found that in COPD patients, psychosocial factors     affect quality of life (QOL) and functioning more than would be expected given the severity     of their disease. To improve QOL and functioning in the approximately 50% of COPD patients     with significant anxiety and/or depressive symptoms, interventions are needed. Much research     documents the utility of cognitive behavioral therapy (CBT) in treating depression and     anxiety, showing it to have promise as a self-management intervention to improve QOL in COPD     patients.   "
172975|NCT00105937|"     The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent     fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid     tolerant.   "
172986|NCT00106080|"     The purpose of this study is to evaluate a multifaceted intervention to improve the quality     of end-of-life communication between patients with COPD and their primary care providers     using information about patients preferences for end of life care and how to communicate and     use this information to activate patients, family members, and healthcare providers.   "
172976|NCT00105950|"     This study was designed to determine how effective and safe a new investigational drug,     lapatinib, is in treating patients with treatment refractory or relapsed inflammatory breast     cancer. Tumor tissue collected pre-treatment and at Day 28 will be examined for biologic     activity by IHC (immunohistochemistry). Treatment will consist of daily oral therapy with     lapatinib. A patient may continue treatment as long as they are receiving benefit. Blood     samples for hematology and chemistry panels, MUGA/ECHO (multigated     acquisition/echocardiogram) exams and physical exams will be performed throughout the study     to monitor safety.   "
172977|NCT00105963|"     This research project seeks to implement an early intervention program that can be effective     in the prevention of Shaken Baby Syndrome (SBS) and infant abuse. Our hypothesis is that the     Period of PURPLE Crying intervention program can reduce shaking and abuse of infants through     changes in knowledge, attitudes and behaviors about early infant crying, especially     inconsolable crying. In this 3-year project, we will implement and evaluate an intervention     program in selected prenatal classes, hospitals, and primary care pediatric practices.      In this randomized, controlled trial, we will enroll a total of 3000 women/families who are     about to give birth or have just given birth to a healthy infant. At each of the three sites     (newborn nursery, pediatrician offices and prenatal classes), we will enroll 1000 subjects.     Half of all subjects will receive intervention materials (a video, pamphlet and bib/burp     cloth) about infant crying. The other half, the control group, will receive comparable     materials on infant safety. All subjects will be asked to complete a brief questionnaire at     the time of enrollment (pre test), review the materials they receive, complete the Baby’s Day     Diary for 4 days when the infant is 5 weeks of age and complete a telephone questionnaire     (post test) when the infant is 8 weeks of age.   "
172978|NCT00105976|"     The purpose of this clinical study is to see if an experimental drug, called MM-093, is safe     and effective in the treatment of rheumatoid arthritis. MM-093 is a genetically engineered     version of a naturally occurring protein called alpha fetoprotein (AFP). Adults normally have     very small amounts of AFP in their bloodstream. However, during pregnancy, AFP levels in both     the mother and the fetus are much higher than normal. It has been observed that women with RA     (Rheumatoid Arthritis) have fewer symptoms during pregnancy, particularly during the third     trimester. At this time, the levels of AFP in the blood of the mother and fetus are the     highest. This observation led researchers to begin examining AFP as a possible treatment for     RA.   "
172979|NCT00105989|"     The purpose of this study is to assess the efficacy and safety of duloxetine compared with     placebo in the prevention of depressive recurrences among patients with recurrent major     depressive disorder.   "
172980|NCT00106002|"     The purposes of this study are to determine whether pemetrexed can help patients with     metastatic (cancer that has spread to other parts of the body) breast cancer, to determine     any side effects that may be associated with the drug, to determine how much pemetrexed     should be given to patients, and to collect DNA for future research regarding metastatic     breast cancer. The collection of DNA is optional to the patient.   "
172981|NCT00106015|"     The purpose of this study is to maintain a comprehensive registry of patients with the rare     inherited bone marrow failure syndrome Diamond Blackfan anemia (DBA).   "
172982|NCT00106028|"     Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There     are no approved drugs for the treatment of OI in children, even though some intravenous (IV)     bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic     study, data showed that risedronate was well tolerated in 28 children with OI. This three     year study will test the safety and efficacy of risedronate in the treatment of children with     OI. For the first year, patients will be randomized to the risedronate and placebo groups in     a 2:1 ratio. For the second and third years of the study, all patients will receive     risedronate.   "
172983|NCT00106041|"     Improving end-of-life care is of critical importance to the VA as it faces an increasingly     aging and dying veteran population. Previous work within and outside of the VA has     demonstrated serious deficiencies in the quality of care delivered near the end of life.     Moreover, veterans in the VA system suffer from a higher rate of chronic and life-limiting     illnesses and decrements in health-related quality of life compared with the age-matched     controls. In FY2000 approximately 104,000 enrolled veterans died in the U.S. including 27,200     that died as inpatients in VA acute or chronic care medical wards. The care model on which     the proposed study is based is theoretically sound and has been piloted in a study that     suggested its use can help the VA achieve substantial quality improvement at reduced costs.   "
173880|NCT00118443|"     This study will determine whether a training program designed to help school staff members     identify adolescents at risk for suicide will increase the number of students who are     referred to mental health services.   "
172984|NCT00106054|"     The study was terminated early due to low enrollment with only 2 subjects enrolled and     treated after being open for enrollment for over a year. Therefore, no meaningful efficacy     analyses could be performed.      This trial is studying the effects (good and bad) of a combination of drugs, Irinotecan in     combination with infusional 5-FU, leucovorin (FOLFIFI) plus Bevacizumab, for cancer of the     colon or rectum that has spread to the liver only and is currently not able to be removed by     surgery. All of the drugs that will be received in this research study have been approved in     the United States for colorectal cancer, that has spread to other areas of the body,     including the liver. Another reason for doing this study is to see if the chemotherapy drugs     FOLFIFI plus Bevacizumab can sufficiently decrease the size of the cancer in the liver so     that any tumor remaining can be completely removed with surgery and, if it can be removed     whether doing so will prolong the time it takes the cancer to return and/or prolong the life     of these patients. This trial is also looking at the genes of people who take part in this     study, to see if it is possible to find out characteristics that can help predict whose     cancer will respond well or not so well, and who will have more or less side effects to this     chemotherapy.   "
172985|NCT00106067|"     The diagnosis of advanced, incurable cancer at different stages of the adult life span holds     a variety of meanings for family members who often must play critical roles in patient care     and decision-making. Family caregivers are greatly affected by the diagnosis and treatment of     late-stage cancer in a loved one and may find it difficult to meet the demands of taking care     of their loved one through end-of-life care and taking care of their own well-being. This     grant provides funding to examine processes and outcomes of the intervention for family     caregivers of advanced cancer patients.   "
173024|NCT00098241|"     The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican)     administered to pediatric renal transplant recipients, and to provide additional safety data.   "
172987|NCT00106093|"     The purpose of this study is to gather information about people s drinking histories and to     evaluate them for other research studies being conducted at the National Institute on Alcohol     Abuse and Alcoholism (NIAAA). The evaluation will include a physical examination, blood     tests, an MRI scan of the brain and completion of various questionnaires about alcohol use     and mood. The information gathered from all of these tests will be used by researchers to     gain a better understanding of the disease of alcoholism and determine eligibility for other     NIAAA studies. This is an inpatient study so participants will stay at the NIH hospital for     at least three weeks and up to six weeks if a person is found to be eligible for other NIAAA     research studies.      The study is open to people age 18 and older whose alcohol drinking has caused significant     problems in their lives, and who desire alcoholism treatment. Detoxification will be provided     if needed, and each person may participate in our alcoholism treatment program. The treatment     includes group and individual counseling sessions as well as self-help meetings such as AA.     Family counseling and recreational opportunities are also an important part of the treatment     experience. The doctors, nurses, social workers and all of our other staff are committed to     helping participants design an aftercare program that will help them leave the hospital and     remain sober. Participants may also be able to attend a 12-week aftercare program in the     NIAAA outpatient clinic.   "
172988|NCT00106106|"     This study will examine whether a new drug called acamprosate can be helpful for alcohol     withdrawal, a result of drinking high amounts of alcohol for long periods of time. Alcohol     withdrawal can cause various symptoms, including nausea or vomiting, anxiety or depression,     tremor, high blood pressure, and others. During withdrawal, brain chemicals called     neurotransmitters change, with some rising to abnormally high levels. These changes may     contribute to alcohol craving, drinking relapse and impaired mental performance. This study     will see if taking acamprosate for 4 weeks can lower the levels of neurotransmitters, such as     glutamate, lessen withdrawal symptoms and decrease alcohol craving and brain damage     associated with withdrawal.      Healthy normal volunteers and alcohol-dependent patients between 21 and 65 years of age may     be eligible for this study.      Participants are admitted to the hospital for 28 days. They receive standard inpatient care     for alcohol detoxification, including a medical history and physical examination,     neurological evaluation, laboratory tests, nursing, nutrition, discharge planning and     referrals for treatment of concomitant conditions, if needed. In addition, they are randomly     assigned to take either two acamprosate or two placebo pills three times a day for 28 days     and undergo the following tests and procedures:        -  Days 1-28: Drug treatment. Patients take acamprosate or placebo daily. Patients with          severe withdrawal symptoms may also receive diazepam (Valium). Throughout their          hospitalization, patients fill out questionnaires about their emotional state and          personality and are interviewed by staff about their mental health, use of alcohol,          cigarettes, and illicit drugs, employment, support systems and family and social          relationships, and their legal status.        -  Days 2 and 3: Blood tests. Blood is tested for levels of the stress hormones cortisol          and ACTH, which are released to excess during alcohol withdrawal. For this test, a          heparin lock (thin, flexible plastic tube with a rubber stopper on the end) is placed in          an arm vein for blood collections each day at 6 AM, 12 noon, 6 PM and 12 midnight.          Patients rest in bed for 30 minutes before each collection.        -  Day 4: Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). These          procedures are done at the same time. They use a strong magnetic field and radio waves          to show structural and chemical changes in the brain. The patient lies on a table in a          space enclosed by a metal cylinder (the scanner) for about 20 to 30 minutes during the          test.        -  Day 5: Lumbar puncture (spinal tap). A local anesthetic is given to numb the area for          the procedure. Then, a needle is inserted in the space between the bones in the lower          back where the cerebrospinal fluid circulates below the spinal cord. A small amount of          fluid is collected through the needle.        -  Days 5 and 6: Dexamethasone-corticotropin releasing factor (CRF) test. This test          measures the effect of alcohol withdrawal on ACTH and cortisol. The patient takes a          standard dose of the steroid dexamethasone at 11 PM on day 5. At noon the next day, they          are given lunch and then stay in bed and rest. A plastic tube is put in an arm vein. A          salt water solution is slowly infused through the catheter and a blood sample is          withdrawn through it. At 3 p.m., the patient is given 100 micrograms of the hormone CRF.          Repeated blood samples are obtained to measure ACTH and cortisol.        -  Days 23-27: All of the tests done on days 2-6 are repeated, except the MRI. MRS is          repeated to measure neurotransmitters.   "
172989|NCT00106119|"     This study will examine how two thyroid preparations-levothyroxine (T4) and liothyronine     (T3)-affect fat and cholesterol metabolism, blood sugar regulation, and thyrotropin secretion     in patients who have had their thyroid gland removed. Results of the study may help in the     development of better therapies to optimize blood sugar and cholesterol levels in some     patients.      Patients 18 years of age or older who have had most or all of their thyroid gland removed and     are taking long-term thyroid hormone medication may be eligible for this study after     screening.   "
172990|NCT00106132|"     This study will compare the safety and effectiveness of two treatments-injections of     triamcinolone acetonide into the eye vs. standard laser therapy-for macular edema (swelling     in the center of the retina) that is caused by blockage in a retinal blood vessel. Edema     caused by blockage in a large vessel is called central retinal vein occlusion (CRVO). Edema     caused by blockage in a smaller vein is called branch retinal vein occlusion (BRVO).     Triamcinolone acetonide is a steroid drug that reduces swelling; the Food and Drug     Administration has approved it for injection into joints and muscles to treat inflammatory     conditions.      Patients 18 years of age and older with macular edema due to CRVO or BRVO of between 3 and 18     months' duration may be eligible for this study. Candidates are screened with a medical     history, blood pressure measurement, and urine pregnancy test for women who can become     pregnant. Screening also includes the following procedures:        -  Eye examination to assess visual acuity and eye pressure, and to examine the cornea,          lens, and retina. The pupils are dilated with drops for this examination.        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina          are taken using a camera that flashes a blue light into the eye. The pictures show if          any dye has leaked from the vessels into the retina, indicating possible blood vessel          abnormality.        -  Optical coherence tomography to measure retinal thickness. The eye is examined with a          machine that produces cross-sectional pictures of the retina. The patient is seated in          front of a machine and looks at a pattern of flashing and rotating red and green lights,          first with one eye and then with the other.        -  Fundus photography to help evaluate the status of the retina and changes that may occur          in the future. Photographs of the retina are taken using a camera that flashes a bright          light into the eye.      Participants are randomly assigned to receive triamcinolone injections or standard treatment.     Triamcinolone is given in either a 1-mg or 4-mg dose. Standard treatment for CRVO and for     BRVO with excessive blood in the retina is observation. Standard treatment for BRVO without     excessive blood is laser therapy. Patients with BRVO who do not qualify for laser therapy     when they enter the study may have it later if blood clears enough to permit treatment. The     procedures for triamcinolone injections and laser therapy are as follows:        -  Triamcinolone acetonide: The eye is numbed with anesthetic drops and the study drug is          injected into the vitreous, the jelly-like substance located between the back of the          lens and the retina. Patients apply antibiotic drops at home for 3 days following the          procedure.        -  Laser treatment: The eye is numbed with anesthetic drops and a special contact lens is          placed on the eye during the laser beam application.      All patients are followed every 4 months for 3 years. Additional visits may be scheduled if     needed. Patients who receive triamcinolone injections are also examined within 1 week of each     injection and 1 month after each injection. At the 4-month visits patients undergo repeat eye     examination and fundus photography. Optical coherence tomography is done at some visits, and     fluorescein angiography is repeated at months 4, 12 and 24. Blood pressure is measured at     months 12, 24 and 36. Patients may be retreated with triamcinolone injections or laser     therapy as often as every 4 months, depending on their response to treatment.   "
172991|NCT00106145|"     An investigational study to determine the safety/tolerability, and efficacy of a notch     signaling pathway inhibitor in patients with metastatic or locally advanced breast cancer and     other advanced solid tumors.   "
172992|NCT00106158|"     The purpose of this study is to assess the safety of repeated doses of cholesterol-bearing     hydrophobized pullulan (CHP) and NY-ESO-1 protein (CHP-NY-ESO-1) and describe the NY-ESO-1     specific-humoral and cellular immune response to immunization with CHP-NY-ESO-1 in patients     with cancer expressing NY-ESO-1.   "
172993|NCT00106171|"     It is not known if anti-HIV treatment for recently infected patients improves long-term     patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV     medications slows progression of HIV disease in adults recently infected with HIV.      Study hypothesis: A one-year course of HAART administered during acute or early     seroconversion may slow the progression of HIV infection.   "
172994|NCT00106184|"     Rituximab is a man-made antibody used to treat certain types of cancer. This study will     determine whether rituximab is an effective treatment for adult and pediatric patients with     dermatomyositis or polymyositis.      Study hypotheses: 1) The time to improvement in Group A patients (receiving rituximab first)     will occur significantly earlier than in Group B patients (receiving rituximab later). 2) The     proportion of patients improved at Week 8 of the treatment phase will be significantly     greater in Group A than in Group B.   "
172995|NCT00106197|"     This study will determine whether there are age-related differences in the body systems     controlling sleep and stress hormone patterns. This study will also determine whether the     differences in sleep and hormone patterns between depressed adolescents and adults are     associated with differences in their response to antidepressant treatment.   "
172996|NCT00106210|"     This study will determine the impact of early intervention on the communication and social     development of toddlers with autism.   "
172997|NCT00106223|"     In an earlier phase of this study, a cognitive behavioral therapy (CBT) manual to treat body     dysmorphic disorder (BDD) symptoms was developed. We are currently implementing this     manual-based treatment to validate its effectiveness in patients with BDD.   "
172998|NCT00106236|"     The purpose of the study is to determine whether exercise has further beneficial effects on     improving cardiovascular risk factors such as hypertension, high cholesterol level or     diabetes mellitus, when added to the standard program of health check followed by life style     recommendations.   "
172999|NCT00106249|"     This study will evaluate the clinical efficacy of functional Magnetic Resonance Imaging     (fMRI) guided 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS) applied to the     Supplementary Motor Area (SMA) in OCD patients who have not fully responded to conventional     therapies. The investigators will collect TMS measures of motor cortex excitability to test     whether rTMS restores normal levels of intracortical inhibition found to be deficient in OCD.     The investigators hypothesize that:        1. Compared to sham (placebo), active rTMS will improve symptoms of OCD as assessed with          the Yale Brown Obsessive Compulsive Scale (Y-BOCS) and Clinical Global Impression (CGI).        2. Active (but not sham) rTMS will normalize levels of motor cortex excitability, as          reflected by increased intracortical inhibition, motor threshold, and cortical silent          period, and by decreased intracortical facilitation, relative to pre-treatment baseline.   "
173000|NCT00106262|"     This study is conducting an evaluation of two chemotherapy drugs, Velcade and Irinotecan, in     women with advanced, recurrent, or metastatic cervical cancer, vaginal cancer, or vulvar     cancer. Patients with cervical cancer may have received a platinum-containing treatment as     systemic therapy without radiation, but is not required.   "
173017|NCT00098137|"     Hypothesis:      Blocking the angiotensin (AT) II type 1 receptor (Olmesartan) reduces the incidence of     episodes of atrial fibrillation in patients with paroxysmal atrial fibrillation during 12     months by more than 25% compared to standard medication without angiotensin II type 1     receptor.      A total of 422 subjects will be included in the two study groups. The treatment arm will     receive 40mg Olmesartan per day, the remaining patients will receive placebo. Follow-up is 12     months. Daily Tele-ECG recordings will determine the cardiac rhythm and asymptomatic episodes     of atrial fibrillation (AF) every day. Concomitant therapy with AV-nodal blocking drugs are     allowed during the study. In case of severe AF-induced symptoms, an antiarrhythmic recovery     medication (amiodarone) is allowed during follow-up.   "
173025|NCT00098254|"     This study will investigate the effects and side effects of BAY 43-9006 in patients with     advanced, recurrent, or refractory non-small cell lung cancer (NSCLC). BAY 43-9006 is one of     a new class of anticancer agents known as bi-aryl ureas.      Patients 18 years of age and older with NSCLC that has recurred or progressed after one     regimen of chemotherapy may be eligible for this study. Candidates are screened with a     medical history and physical examination; blood tests; tumor biopsy (see below); chest x-ray;     electrocardiogram; and imaging studies, including positron emission tomography-computed     tomography (PET-CT, see below) and dynamic, contrast-enhanced MRI (DCE-MRI, see below).      Participants take BAY 43-9006 by mouth twice a day, morning and evening. On the first and     15th days of treatment, patients are admitted to the hospital for pharmacokinetic studies;     that is, a test of how the body handles the drug. For the test, blood is collected at     intervals (at 15 minutes, 30 minutes, and 1, 2, 4, 6, 8, 12 and 24 hours after ingestion) to     determine the drug's level in the bloodstream. Treatment with BAY 43-9006 continues until the     study doctor determines that the medication is not beneficial or the patient wishes to     withdraw from the study.      In addition to drug therapy, patients undergo the following tests and procedures:        -  Physical examination every 4 weeks        -  Blood pressure checks once a week during the first 4 weeks        -  Blood tests every week        -  CT scans or other imaging tests, such as ultrasound or MRI, every 8 weeks to evaluate          the tumor's response to treatment. CT is an x-ray test that provides detailed pictures          of the inside of the body. It can be done from different angles, providing a          3-dimensional picture of the part of the body being studied and allowing the doctor to          see the location, nature, and extent of disease. MRI uses a powerful magnet and radio          waves instead of x-rays to produce accurate, detailed pictures of organs and tissues.        -  PET-CT approximately every 8 weeks to look at how different parts of the body take up          and use glucose (a sugar nutrient). Because rapidly growing cells, such as tumors, use          more sugar than normal cells do, this test can be used to detect cancer. For the test,          the patient is given an injection of a sugar solution in which a radioactive tracer has          been attached to the sugar molecule. A special camera detects the radiation emitted by          the solution, and the resulting images show how much sugar is being used in various          parts of the body. PET-CT uses the PET scan in combination with standard CT in a machine          that does both tests.        -  DCE-MRI after 2 weeks of treatment. This test uses MRI with a special non-radioactive          dye to examine blood flow in a certain part of the body.        -  Tumor biopsy (optional) after 2 weeks of treatment. A biopsy is the surgical removal of          a small piece of tissue. The tumor biopsy is done either using a small bore needle under          CT guidance or by direct visualization using a laparoscope/thoracoscope. For the needle          biopsy, a needle is inserted through the skin and guided by CT into the tumor mass. For          the laparoscopy/thoracoscopy, the patient is sedated or asleep and small lighted tubes          are inserted into small holes made in the skin. The tumor is located and tissue          withdrawn.   "
173001|NCT00106275|"     Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and sleep disorders being the     main symptoms. There is no commonly accepted efficacious treatment modality. Training in     mindfulness-based stress reduction (MBSR) is a structured, 8-week, cognitively and     affectively oriented intervention program, and has been shown to produce health benefits in a     number of studies.      We plan to conduct a randomized, controlled, clinical study with the aim of testing the     efficacy of MBSR for fibromyalgia. Because fibromyalgia is almost exclusively a female     disorder, we will limit this investigation to women. 180 female, fibromyalgia patients will     be randomized into three groups:        1. Mindfulness training        2. Active control        3. Wait-list control.      The main outcome criteria are self-reported and fibromyalgia-specific Quality of Life (QOL),     and a Biobehavioral Fibromyalgia Index composed of a variety of psychophysiological and     behavioral variables. This index will be generated from data gathered via an ambulatory     psychophysiological monitoring system, which comprises parameters of mobility, sleep quality,     and cardiovascular well-being. These and other relevant variables (depression score, general     QOL, pain quality, anxiety, mindfulness, compliance, other therapeutic measures) will be     assessed at the beginning and end of the training, as well as at 4- and 12-months     post-treatment. A primary focus will be assessing whether it is possible to promote     psychological well-being through the learning of attentive presence and any resultant     affective affirmation.   "
173002|NCT00106288|"     The purpose of this study is to determine the efficacy and safety of micafungin (FK463)     versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic     patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and     pediatric patients.   "
173003|NCT00106301|"     The purpose of this study is to evaluate the safety and tolerability of extended treatment     with FK228 in patients with metastatic renal cell carcinoma or hormone refractory prostate     cancer who have at least demonstrated stable disease on prior Fujisawa sponsored FK228     clinical trials.   "
173004|NCT00106314|"     The purpose of this study is to evaluate the efficacy and safety of Inflabloc Cap     (Dehydroepiandrosterone [DHEA]) in the treatment of patients with moderately active Crohn's     disease.   "
173005|NCT00106327|"     The purpose of this study is to compare the effects of nutrition, a supervised treadmill     exercise program, and supervised progressive resistance training program on peripheral     arterial disease.   "
173006|NCT00106340|"     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a     single oral drug. The purpose of this study is to assess the long term safety and     effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in     lowering overall blood glucose levels when added to metformin in people with type 2 diabetes     not at target blood glucose levels on metformin alone.   "
173007|NCT00106353|"     This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV)     infusion once weekly to pediatric subjects with advanced solid tumors.      Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly     to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or     refractory to standard therapy or for whom standard therapy is not available. (enrollment     completed) Part 2 will be conducted in three groups of children with refractory or relapsed     pediatric solid tumors. Subjects with the following tumor types will be enrolled:     neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV     temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)   "
173008|NCT00106366|"     This trial is conducted in the United States of America (USA). The purpose of this study is     to determine if the use of insulin detemir in combination with insulin aspart is safe and at     least as effective as insulin glargine in combination with insulin aspart for the control of     blood glucose in patients with Type 2 diabetes.   "
173009|NCT00106379|"     The purpose of this study is to provide long-term clinical safety and efficacy data for     tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various     degrees of renal impairment.   "
173010|NCT00106392|"     The purpose of the study is to compare the safety and effectiveness of Prograf in the     prevention of erectile dysfunction in men after a radical prostatectomy.   "
173493|NCT00114764|"     The purpose of this study is to determine if a single dose of pegfilgrastim is able to reduce     the time of severe neutropenia in patients receiving induction and consolidation     myelosuppressive chemotherapy for de novo acute myeloid leukemia similar to filgrastim.   "
173011|NCT00106405|"     Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has     considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric     emergencies and is associated with significant morbidity and mortality. The purpose of the     study is to evaluate the safety and efficacy of open-label memantine in the acute management     of adults with bipolar I disorder hospitalized for mania.   "
173012|NCT00106418|"     The purpose of this study is to evaluate the activity of romidepsin (depsipeptide,FK228) in     patients with metastatic prostate cancer who have developed a rising prostate specific     antigen (PSA) while undergoing hormonal therapy.   "
173013|NCT00098085|"     Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an     autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with     resectable non-small cell lung cancer.      Vaccine production will be attempted on all patients who undergo surgery and meet all     inclusion/exclusion criteria.   "
173014|NCT00098098|"     The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen     (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when     given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day     0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein     dosage level.   "
173015|NCT00098111|"     The purpose of this study is to identify an optimal weight based dose of azathioprine that is     safe and effective in the treatment of subjects with active Crohn's disease requiring     treatment with corticosteroids, and for maintaining remission in those subjects.   "
173016|NCT00098124|"     Antidepressants of all varieties represent a common form of therapy for many chronic states     including fibromyalgia. The majority of antidepressants increase the levels of serotonin or     norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and     serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.   "
173018|NCT00098150|"     This extension study is being conducted to collect post-treatment safety information on     patients who previously participated in the core clinical trial.   "
173026|NCT00098267|"     This study will explore how bacteria colonize human teeth and how this process changes over     the lifetime of individuals. It will include an investigation of transmission of bacteria     that initiate colonization between adults and from adults to infants.      Selected NIH scientists and members of their immediate families, including infants, are     eligible for this study. Participants provide a small sample of saliva and a sample of     bacteria collected by rubbing a cotton swab over the surfaces of the lower four incisors.     Adults collect and submit their own specimens; a dentist collects specimens from children.   "
173027|NCT00098280|"     This study will examine the safety and effectiveness of the experimental drug eculizumab in     treating patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disorder of red     blood cells that leads to premature destruction of the cells and resulting anemia. Patients     may be at high risk of blood clots and may develop bone marrow failure or aplastic anemia,     with low white blood cell and platelet counts. Eculizumab is a monoclonal antibody that may     help improve the survival of red blood cells.      Patients 18 years of age and older with PNH who require blood transfusions for anemia and     have received at least four transfusions in the 12 months preceding evaluation for this study     may be eligible to enroll. Candidates are screened with a medical history, physical     examination, and check of vital signs.      Participants have an electrocardiogram (EKG) and blood and urine tests, and are vaccinated     against Neisseria meningitides, a common bacteria that can cause a disabling or fatal type of     meningitis. They then enter an observation phase of the study, with monthly visits during     which they complete a questionnaire; update their health status, transfusion record, and     medication use; have their vital signs checked and PNH symptoms evaluated; have blood and     urine tests; and receive a transfusion, if necessary. These visits continue for up to 3     months until patients receive a qualifying transfusion; that is, a transfusion given as a     consequence of a certain hemoglobin level with symptoms or a different level without     symptoms.      Patients are then randomly assigned to receive either eculizumab or a placebo (salt solution     with no active ingredient). Both study medications are given intravenously (through a vein)     over 30 minutes once a week for five doses and then once every 2 weeks for another 11 doses.     At each treatment visit (study weeks 0-24), patients update their health status, transfusion     records, and medication use; have their vital signs checked; and provide a blood sample. At     various visits, they also complete a questionnaire, provide a urine sample and have an EKG.     At the last treatment visit (week 26 or the final visit for patients who end their     participation before visit 18) patients have a complete physical examination in addition to     the procedures listed above.   "
173028|NCT00098293|"     Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown     to be active in vitro against a wide range of clinical isolates (including those resistant to     existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy     for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available     agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300     mg twice daily. No significant effects were seen on the QTc interval. The goal of this study     is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each     are combined with two other antiretroviral agents, in patients who are previously naive to     antiretroviral therapy. This study will involve approximately 200 centers from around the     world to achieve a total randomized subject population of 1071 subjects. Patients will be     randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to     zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily     added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily)     added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over     approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks     of treatment. This may be extended for an additional 3 years depending on the results at 96     weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24,     32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4,     8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn     twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857)     pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for     non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at     study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed,     at selected centers, at study entry and week 96. Patients will be asked to complete a symptom     distress questionnaire at study entry, weeks 12, 24, 48 and 96.   "
173029|NCT00098306|"     Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown     to be active in vitro against a wide range of clinical isolates (including those resistant to     existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy     for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available     agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300     mg twice daily. No significant effects were seen on the QTc interval. The purpose of this     study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected,     treatment experienced patients who are failing their current antiretroviral regimen and are     infected with R5-tropic virus exclusively. This study will involve more than 100 centers from     the US and Canada to achieve a total randomized subject population of 500 subjects. Patients     will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT     (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150     mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The     study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be     extended for an additional year depending on the results at 48 weeks. Physical examinations     will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48. Blood samples     will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.     Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24     for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood     sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo     a 12-lead electrocardiogram at study entry, weeks 24 and 48.   "
173030|NCT00098319|"     Cleft lip and palate are a significant component of morbid human birth defects in the     developing world. By supplementing a high-risk group of women with folic acid (4.0 mg versus     0.4 mg) from preconception and continuing throughout the first 3 months of pregnancy in the     state of Sao Paulo, Brazil, this study aims to reduce the recurrence of cleft lip and palate.   "
173031|NCT00098332|"     RATIONALE: Forodesine (BCX-1777) may stop the growth of cancer cells by blocking the enzymes     necessary for their growth.      PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have     refractory stage IIA, stage IIB, stage III, stage IVA, or stage IVB cutaneous T-cell     lymphoma.   "
173032|NCT00098345|"     The purpose of this open label, two stage, phase II study is to evaluate the efficacy and     tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary     thyroid carcinoma.   "
173033|NCT00098358|"     Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4)     is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4     is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase.     This study will test the safety and efficacy of zileuton in the treatment of facial acne.   "
173034|NCT00098371|"     This phase II trial is studying how well flavopiridol works in treating patients with chronic     lymphocytic leukemia or prolymphocytic leukemia. Drugs used in chemotherapy, such as     flavopiridol, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing   "
173035|NCT00098384|"     The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in     the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.   "
173036|NCT00098397|"     This phase II trial is studying how well FR901228 works in treating patients with metastatic     breast cancer. Drugs used in chemotherapy, such as FR901228, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     FR901228 may also stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth   "
173037|NCT00098423|"     This phase I trial is studying the side effects and best dose of tanespimycin when given with     cytarabine in treating patients with relapsed or refractory acute myeloid leukemia, acute     lymphoblastic leukemia, chronic myelogenous leukemia, chronic myelomonocytic leukemia, or     myelodysplastic syndromes. Drugs used in chemotherapy, such as tanespimycin and cytarabine,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Tanespimycin may also help cytarabine kill more cancer cells by     making cancer cells more sensitive to the drug. Giving tanespimycin together with cytarabine     may kill more cancer cells.   "
173038|NCT00098436|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide and VNP40101M, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Temozolomide may also help VNP40101M kill more cancer cells by making cancer cells     more sensitive to the drug. Giving temozolomide together with VNP40101M may kill more cancer     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide and     VNP40101M in treating patients with relapsed or refractory leukemias.   "
173039|NCT00098462|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as sirolimus, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells.     The tumor is said to be resistant to chemotherapy. Giving gefitinib together with sirolimus     may reduce drug resistance and allow the tumor cells to be killed.      PURPOSE: This phase I/II trial is studying the side effects and best dose of sirolimus when     given with gefitinib and to see how well they work in treating patients with recurrent or     refractory stage IIIB or stage IV non-small cell lung cancer.   "
173040|NCT00098475|"     This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how     well it works compared to lenalidomide and standard-dose dexamethasone, given with or without     thalidomide, in treating patients with multiple myeloma. Biological therapies, such as     lenalidomide, may stimulate the immune system in different ways and stop cancer cells from     growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by     blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill     more cancer cells.   "
173041|NCT00098488|"     This phase I trial is studying the side effects and best dose of     17-N-allylamino-17-demethoxygeldanamycin when given with or without rituximab in treating     patients with relapsed B-cell chronic lymphocytic leukemia or prolymphocytic leukemia. Drugs     used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others     interfere with the ability of cancer cells to grow and spread. Monoclonal antibodies may kill     cancer cells that are left after chemotherapy. Giving     17-N-allylamino-17-demethoxygeldanamycin with or without rituximab may kill more cancer     cells.   "
173042|NCT00098501|"     This phase I trial is studying the side effects, best way to give, and best dose of CCI-779     and EKB-569 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such     as CCI-779, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. EKB-569 may stop the growth of tumor cells by     blocking some of the enzymes needed for their growth. Giving CCI-779 together with EKB-569     may kill more tumor cells.   "
173043|NCT00098514|"     RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I trial is studying side effects, best way to give, and best dose of     talotrexin in treating patients with advanced or recurrent solid tumors.   "
173494|NCT00114777|"     The purpose of this trial is to learn if Belatacept is effective and safe as a first line of     immunosuppression treatment in patients undergoing a renal transplant where the donor kidney     is obtained in patients with extended criteria.   "
173044|NCT00098527|"     This phase II trial is studying how well FR901228 works in treating patients with refractory     stomach cancer or gastroesophageal junction. Drugs used in chemotherapy, such as FR901228,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. FR901228 may also stop the growth of tumor cells by blocking     some of the enzymes needed for their growth.   "
173045|NCT00098540|"     This phase II trial is studying how well sorafenib works in treating patients with stage IIIB     or stage IV non-small cell lung cancer. Sorafenib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. It may also stop the growth of non-small     cell lung cancer by blocking blood flow to the tumor.   "
173046|NCT00098553|"     RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with     stage IV melanoma.   "
173047|NCT00098566|"     RATIONALE: Studying the long-term effects of cancer treatment in cancer survivors may help     improve the ability to plan effective treatment and follow-up care.      PURPOSE: This phase II trial is studying the long-term effects of iodine I 131 tositumomab     and autologous bone marrow or stem cell transplantation in patients with relapsed or     refractory non-Hodgkin's lymphoma.   "
173048|NCT00098579|"     This phase I trial is studying the side effects and best dose of alvocidib when given with     doxorubicin hydrochloride in treating patients with metastatic or recurrent sarcoma that     cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride     and alvocidib, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Alvocidib may also help doxorubicin     hydrochloride work better by making tumor cells more sensitive to the drug. Giving more than     one drug may kill more tumor cells   "
173049|NCT00098605|"     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their     growth. This phase II trial is studying how well lapatinib works in treating brain metastases     in patients with stage IV breast cancer and brain metastases.   "
173050|NCT00098618|"     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for their     growth or by blocking blood flow to the tumor. Interferon alfa may interfere with the growth     of tumor cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa kill     more tumor cells by making tumor cells more sensitive to the drug. Giving sorafenib together     with interferon alfa may kill more tumor cells. This phase II trial is studying how well     giving sorafenib with interferon alfa works in treating patients with locally advanced or     metastatic kidney cancer.   "
173051|NCT00098631|"     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their     growth. This phase II trial is studying how well lapatinib works in treating patients with     recurrent and/or metastatic head and neck cancer.   "
173052|NCT00098670|"     This phase II trial is studying how well giving fludarabine together with rituximab followed     by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal     antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways.     Some block the ability of cancer cells to grow and spread. Others can find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as fludarabine, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Giving fludarabine together with rituximab     followed by alemtuzumab may kill more cancer cells.   "
173053|NCT00098683|"     RATIONALE: Drugs used in chemotherapy, such as amifostine, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well amifostine works in treating young patients     with newly diagnosed de novo myelodysplastic syndromes.   "
173054|NCT00098709|"     The purpose of this study is to determine if the information provided to the physician by a     fetal pulse oximeter during labor will reduce the chances of a cesarean delivery.   "
173055|NCT00098722|"     Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown     to be active in vitro against a wide range of clinical isolates (including those resistant to     existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy     for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available     agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300     mg twice daily. No significant effects were seen on the QTc interval. The purpose of this     study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected,     treatment experienced patients who are failing their current antiretroviral regimen and     infected with R5-tropic virus exclusively. This study will involve more than 100 centers in     Europe and Australia to achieve a total randomized subject population of 500 subjects.     Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background     Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc     (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily,     or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of     treatment. This may be extended for an additional year depending on the results at 48 weeks.     Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40     and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32,     40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at     weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical     study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients     will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.   "
173056|NCT00098735|"     In patients who receive an organ transplant, their body considers this organ as foreign and     attempts to destroy it. This is called rejection. All patients who receive an organ     transplant, will take a combination of anti-rejection medications. These medications prevent     the new organ from being rejected from the body. FTY720 is a new compound that helps prevent     organ rejection.   "
173069|NCT00098917|"     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body     build an effective immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients who are undergoing surgery for stage IB, stage II, or stage IIIA non-small     cell lung cancer.   "
173070|NCT00098943|"     RATIONALE: Targeted therapy with tumor necrosis factor combined with a fusion protein may     stop the growth of solid tumors by stopping blood flow to the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of NGR-TNF in treating     patients with advanced solid tumors.   "
173057|NCT00098748|"     Maraviroc (UK-427,857), a selective and reversible CCR5 co-receptor antagonist, has been     shown to be active in vitro against a wide range of clinical isolates (including those     resistant to existing classes). In HIV-1 infected patients in the United States, maraviroc     (UK-427,857) is approved for use as part of combination antiretroviral treatment in     treatment-experienced and treatment-naive adult subjects. At least 50% of     treatment-experienced patients are infected with R5-tropic HIV-1 exclusively. However, even     in patients infected with a dual tropic (R5 + X4) phenotype, a large proportion of the virus     population still uses CCR5 exclusively. Thus, the purpose of this study is to evaluate the     antiretroviral activity, and safety, of maraviroc (UK-427,857) (in combination with other     agents) in HIV infected, treatment experienced patients who are failing their current     antiretroviral regimen and not infected with R5-tropic virus exclusively. This study will     involve more than 200 centers globally to achieve a total randomized subject population of     192 subjects. Patients will be randomly (1:1:1) assigned to one of three groups: Optimized     Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] +     maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken     twice daily, or OBT alone. Randomization was stratified by Enfuvirtide use in OBT (yes/no)     and Screening HIV-1 RNA level (viral load) (<100,000/≥ 100, 000 copies per milliliter [copies     per mL]). The study will enroll over approximately a 9 month period with 48 weeks of     treatment. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20,     24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16,     20, 24, 32, 40, and 48. Additionally, blood samples will be drawn twice, at least 30 minutes     apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this     clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis.     Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.   "
173058|NCT00098761|"     RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop     tumor cells from dividing so they stop growing or die.      PURPOSE: This phase I trial is studying the side effects and best dose of VNP40101M in     treating young patients with recurrent, progressive, or refractory primary brain tumors.   "
173059|NCT00098774|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as rituximab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Giving rituximab with combination chemotherapy may kill     more cancer cells.      PURPOSE: This phase II trial is studying how well rituximab given with combination     chemotherapy works in treating patients with newly diagnosed primary CNS lymphoma.   "
173060|NCT00098787|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, leucovorin, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the     tumor. Giving bevacizumab together with combination chemotherapy may be a better way to block     tumor growth. Studying the amount of an enzyme found in the tumor may help doctors plan the     best treatment.      PURPOSE: This randomized phase II trial is studying giving bevacizumab, oxaliplatin, and     irinotecan or giving bevacizumab, oxaliplatin, leucovorin, and fluorouracil in treating     patients with metastatic or recurrent colorectal cancer.   "
173061|NCT00098800|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of fenretinide may prevent ovarian cancer.      PURPOSE: This randomized clinical trial is studying how well fenretinide works in preventing     ovarian cancer in participants who are at high risk of developing ovarian cancer and planning     to undergo surgery to remove the ovaries.   "
173062|NCT00098813|"     This phase II trial is studying how well romidepsin works in treating patients with recurrent     and/or metastatic thyroid cancer that has not responded to radioactive iodine. Romidepsin may     stop the growth of tumor cells by blocking the some of the enzymes needed for cell growth. It     may also help radioactive iodine and chemotherapy work better by making tumor cells more     sensitive to the drug   "
173063|NCT00098826|"     Phase I trial to study the effectiveness of SB-715992 in treating patients who have acute     leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes. Drugs used in     chemotherapy, such as SB-715992, work in different ways to stop cancer cells from dividing so     they stop growing or die   "
173064|NCT00098839|"     This Phase II trial is studying how well giving epratuzumab together with an established     chemotherapy platform works in treating young patients with relapsed acute lymphoblastic     leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Chemotherapy drugs work in     different ways to stop the growth of cancer cells, either by killing them or by stopping them     from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer     cells more effectively.   "
173065|NCT00098852|"     RATIONALE: Drugs such as rosiglitazone may make tumor cells more sensitive to radioactive     iodine.      PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients     with locoregionally extensive or metastatic thyroid cancer.   "
173066|NCT00098865|"     RATIONALE: Thalidomide may stop the growth of tumor cells by stopping blood flow to the     tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor     cells from dividing so they stop growing or die. Combining thalidomide with temozolomide may     kill more tumor cells.      PURPOSE: This phase II trial is studying the effectiveness of combining thalidomide with     temozolomide in treating young patients who have relapsed or progressive brain tumors or     recurrent neuroblastoma.   "
173067|NCT00098878|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This randomized phase III trial is comparing different doses of carboplatin to see     how well they work in treating patients with stage IC, stage II, stage III, or stage IV     ovarian, fallopian tube, or primary peritoneal cancer.   "
173068|NCT00098891|"     Phase I trial to study the effectiveness of combining MS-275 with isotretinoin in treating     patients who have metastatic or advanced solid tumors or lymphomas. MS-275 may stop the     growth of cancer cells by blocking the enzymes necessary for their growth. Isotretinoin may     help cancer cells develop into normal cells. MS-275 may increase the effectiveness of     isotretinoin by making cancer cells more sensitive to the drug. MS-275 and isotretinoin may     also stop the growth of solid tumors or lymphomas by stopping blood flow to the cancer.     Combining MS-275 with isotretinoin may kill more cancer cells   "
173071|NCT00098956|"     This phase II trial is studying how well giving UCN-01 together with topotecan works in     treating patients with small cell lung cancer that relapsed or progressed after previous     chemotherapy. Drugs used in chemotherapy, such as topotecan, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     UCN-01 may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. It may also increase the effectiveness of topotecan by making tumor cells more     sensitive to the drug. Giving UCN-01 together with topotecan may kill more tumor cells.   "
173072|NCT00098969|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of resveratrol may prevent cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in     preventing cancer in healthy participants.   "
173073|NCT00098982|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth. It may also help the chemotherapy drugs work better by     making tumor cells more sensitive to the drugs. Giving bortezomib with fluorouracil,     leucovorin, and oxaliplatin may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     given with fluorouracil, leucovorin, and oxaliplatin in treating patients with advanced or     metastatic colorectal cancer.   "
173074|NCT00098995|"     RATIONALE: Drugs used in chemotherapy, such as tirapazamine and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Tirapazamine may help cisplatin kill more tumor cells by making tumor cells more     sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells.     Tirapazamine may also make tumor cells more sensitive to radiation therapy. Giving radiation     therapy in different ways together with combination chemotherapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of tirapazamine when     given together with cisplatin and radiation therapy in treating patients with stage IB, stage     II, stage III, or stage IVA cervical cancer.   "
174439|NCT00117481|"     This is a 3-arm, multicenter, double-blind, randomized, placebo-controlled study to evaluate     the efficacy of DR-2001 in endometriosis-related symptoms, primarily nonmenstrual pelvic     pain, over a 12-week treatment period.   "
173075|NCT00099008|"     RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the     development or recurrence of cancer. The use of genistein may be effective in preventing     breast or endometrial cancer.      PURPOSE: This randomized phase I trial is studying the effectiveness of genistein in     preventing breast or endometrial cancer in healthy postmenopausal women.   "
173076|NCT00099021|"     This phase II trial studies how well pioglitazone hydrochloride works in preventing head and     neck cancer in patients who have oral leukoplakia. Chemoprevention therapy is the use of     certain drugs to try to prevent the development or recurrence of cancer. The use of     pioglitazone hydrochloride may be effective in preventing head and neck cancer.   "
173077|NCT00099047|"     This randomized phase II trial studies how well celecoxib works in preventing multiple     myeloma in patients with monoclonal gammopathy or smoldering myeloma. Chemoprevention therapy     is the use of certain drugs to try to prevent the development or recurrence of cancer. The     use of celecoxib may be effective in preventing multiple myeloma.   "
173078|NCT00099060|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth.      PURPOSE: This phase I/II trial is studying the side effects and best dose of lapatinib and to     see how well it works in treating patients with recurrent glioblastoma multiforme.   "
173079|NCT00099086|"     This phase I trial is studying the side effects and best dose of docetaxel when given with     radiation therapy and hormone therapy in patients with locally advanced prostate cancer.   "
173080|NCT00099099|"     This study is one of three CALERIE trials that test the hypothesis that a reduced calorie,     nutritionally sound diet increases the length of life and prevents some age-related chronic     diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are     participating in the CALERIE trial represent a diversity of subject populations and     interventional strategies.   "
173081|NCT00099112|"     RATIONALE: Testing of skin that has been exposed to artificial sunlight may help in     understanding the genetic processes involved in the development of skin cancer.      PURPOSE: This trial is studying the effect of solar-simulated ultraviolet radiation on skin     with or without sunscreen in healthy adults with skin that burns easily after only slight     tanning during sun exposure.   "
173082|NCT00099125|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in     chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells     from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and     irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.   "
173083|NCT00099138|"     This study is one of three CALERIE trials that test the hypothesis that a reduced calorie,     nutritionally sound diet increases the length of life and prevents some age-related chronic     diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are     participating in the CALERIE trial represent a diversity of subject populations and     interventional strategies.   "
173084|NCT00099151|"     This study is one of three CALERIE trials that test the hypothesis that a reduced calorie,     nutritionally sound diet improves biomarkers of aging and prevents some age-related chronic     diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are     participating in the CALERIE trial represent a diversity of subject populations and     interventional strategies.   "
173101|NCT00099372|"     The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to     evaluate whether the addition of a second surgical procedure in addition to a procedure for     female pelvic organ prolapse (POP) affects the rates of urinary incontinence. This study will     follow women in the CARE study for 10 years from the time of the surgery to compare success     and complication rates in the two groups. Recruitment into this study is open only to women     that already participated in CARE. Recruitment into CARE is closed.   "
173085|NCT00099164|"     Women pregnant with twins or triplets are at high risk of preterm birth, yet no intervention     or approach has served to reduce this risk. A recently completed trial by the NICHD sponsored     Maternal Fetal Medicine Units (MFMU) Network has, for the first time, demonstrated a     treatment that substantially reduces the rate of preterm birth in women at high risk for     preterm delivery (i.e. progesterone therapy). Preterm birth was reduced by 35% among     progesterone-treated women with a singleton pregnancy when compared with women receiving     placebo. The current trial compares weekly treatment by injection of progesterone with     placebo in women pregnant with twins or triplets.   "
173086|NCT00099177|"     This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral     Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing     moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on     days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic     acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is     6-12 months, and the target sample size is 100-500 individuals.   "
173087|NCT00099190|"     The purpose of this study is to determine the safety of ARQ 501 in combination with docetaxel     in patients with advanced or metastatic cancer. In addition, the study is designed to observe     the potential the combination of ARQ 501 and docetaxel have in treating cancer.   "
173088|NCT00099203|"     This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic     acid in patients with malignant bone disease experiencing moderate to severe pain. Patients     will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4     weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of     study treatment is 6-12 months, and the target sample size is 100-500 individuals.   "
173089|NCT00099216|"     The goal of this research study is to evaluate the effectiveness, tolerability and safety of     rivastigmine capsules in males and females between the ages of 50 and 85 years old with     probable vascular dementia.   "
173090|NCT00099229|"     This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the     treatment of manic episodes of bipolar disorder.   "
173091|NCT00099242|"     The goal of this research study is to evaluate the safety and efficacy of the rivastigmine     transdermal patch in patients with probable Alzheimer's Disease.   "
173092|NCT00099255|"     This multi-center, phase II study will be conducted to define the toxicity profile and     antitumor activity of SGN-30 in patients with pcALCL and other closely related     lymphoproliferative disorders.   "
173093|NCT00099268|"     The CELC200A2401 study has been designed in order to evaluate the hypothesis that     administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy     is initiated results in a decrease in the risk of the development of motor complications for     patients with Parkinson's disease.   "
173094|NCT00099281|"     The purpose of this trial is to study DPPE combined with epirubicin and cyclophosphamide in     patients with metastatic and/or recurrent breast cancer who may have received previous     hormone treatment but have not had exposure to anthracycline treatment. Stratification     allocation will be within the following subgroups:        1. Prior cytotoxic treatment;        2. Estrogen receptor status;        3. ECOG performance status;        4. Number of cycles of chemotherapy.   "
173095|NCT00099294|"     The primary objectives of the study is to evaluate the effectiveness and safety of     glufosfamide in subjects with pancreatic cancer who have been previously treated with     gemcitabine as measured by overall survival compared with best supportive care.   "
173096|NCT00099307|"     This study will determine whether magnetic resonance imaging (MRI) can detect damage to     certain parts of the brain and analyze the thickness of the brain's outer surface in patients     with multiple sclerosis. MRI is a diagnostic test that uses a strong magnetic field and radio     waves to obtain images of body organs and tissues. It can sometimes permit diagnosis even     before symptoms develop.      MS is a disease of white matter, the fatty covering around the nerves in the brain and spinal     cord. The nerves themselves are called gray matter. Damage to white matter impairs nerve     function, leading to a variety of symptoms, such as weakness, vision problems, difficulty     walking, paralysis, and others. MRI can detect some changes in white matter, but changes that     may also appear in gray matter may be more difficult to find. This study will use new MRI     techniques to try to identify gray matter damage in patients with MS.      Healthy volunteers and people with MS or clinically isolated syndrome (an early stage of MS     in which the patient has had just one of the problems MS can cause) who are between 18 and 55     years of age may be eligible for this study. Candidates are screened with a medical history     and neurological examination, and blood and urine tests.      Within one month of the screening evaluation, participants undergo MRI scanning on a standard     1.5 Tesla machine to confirm their health status. (The power of the MRI scanner is measured     in Tesla; the higher the Tesla, the better the visualization.) For this procedure, the     subject lies on a table that moves into the scanner (a narrow cylinder with a magnetic     field), and wears earplugs to muffle loud knocking and thumping sounds that occur during the     scanning process. During the procedure, a contrast agent called Gadolinium is injected into     the blood stream to brighten the images. The test lasts about 2 hours, during which time the     subject must lie still for up to a few minutes at a time.      Within a month after the first MRI, participants repeat the test for a second time. The     procedure is identical to the first scan, except a 3.0 Tesla machine is used.   "
173097|NCT00099320|"     This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic     (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured     by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate     glycemic control with OAD alone.   "
173098|NCT00099333|"     This study will look at the safety of substituting exenatide for insulin in patients with     type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).   "
173099|NCT00099346|"     Study with an investigational drug in patients with recurrent or non-responsive colorectal     cancer or other advanced solid tumors.      This is an early phase trial and some specific protocol information is proprietary and not     publicly available at this time. (Full information is available to trial participants).   "
173100|NCT00099359|"     Giving anti-HIV medications to babies born of HIV positive mothers right after birth can     lower the babies' risk of contracting HIV. This study will assess the safety and efficacy of     two different combinations of anti-HIV medications compared to a one drug standard regimen in     preventing mother to baby transmission. The one drug standard treatment and two combinations     to be studied are: 1) zidovudine, 2) zidovudine/nevirapine and 3)     zidovudine/lamivudine/nelfinavir.   "
173102|NCT00099385|"     This project will evaluate the benefit of an enhanced social development program in grades     3-6 to decrease the onset of risky behaviors in pre-adolescents.   "
173103|NCT00099411|"     The purpose of this study is to assess the effect of heart muscle viability on left     ventricular (LV) remodeling after a heart attack; to explore the relationships between     retained viability of the area of tissue death (infarct zone), LV remodeling, response to the     Occluded Artery Trial (OAT) intervention, and response to late percutaneous coronary     intervention of the infarct related artery (IRA).   "
173104|NCT00099424|"     Exercise intolerance and reduced health status have been found in patients with sarcoidosis     and has been related to skeletal muscle weakness. The present researchers reason that     skeletal muscle weakness is, at least in part, related to physical inactivity and therefore     partially reversible following a structured exercise training program. Nevertheless, the     effects of exercise training have never been studied in patients with sarcoidosis. Therefore,     the present study is undertaken to explore the effects of exercise training in patients with     sarcoidosis. A priori, the following hypotheses are formulated:        -  A 12-week exercise training program improves health status, quality of life and exercise          capacity in patients with sarcoidosis as compared to sarcoidosis patients without          exercise intervention.        -  A 12-week exercise training program improves skeletal muscle function and reduces          complaints of anxiety and depression in patients with sarcoidosis as compared to          sarcoidosis patients without exercise intervention.        -  A 12-week exercise training program reduces circulating levels of inflammatory markers          in patients with sarcoidosis as compared to sarcoidosis patients without exercise          intervention.   "
173105|NCT00099437|"     The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant     with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive     advanced breast cancer who have failed on a previous endocrine treatment.   "
173106|NCT00099450|"     The objectives of this study are to look at the safety and tolerability of the experimental     drug, how people process the drug, how the drug affects people, and to identify a dose or     doses to study in subsequent future studies.   "
173145|NCT00099957|"     This study was not conducted in the United States. Many people with type 2 diabetes also have     high cholesterol levels. The purpose of this study was to evaluate the effects of     vildagliptin, an unapproved drug, on blood lipid measures such as triglycerides and     cholesterol in people with type 2 diabetes.   "
173320|NCT00110708|"     The purpose of this study is to determine if human immunoglobulin given by mouth twice a day     is effective in treating the persistent gastrointestinal (GI) problems such as diarrhea,     constipation, abdominal pain, and bloating, in children with autism.   "
173107|NCT00099463|"     This study will test whether an experimental vaccine to protect against severe acute     respiratory syndrome (SARS) is safe, causes any side effects, and causes an immune response.     SARS affects the respiratory system, usually starting with fever and muscle aches. Patients     may get a dry cough and have difficulty breathing. Infection may be mild, but it can lead to     death.      Vaccines contain substances from an infectious agent, such as a virus, that, when injected     into a person's body, stimulates production of antibodies that create resistance, or     immunity, to that agent. The vaccine in this study contains genetic material (DNA) that codes     for a protein found in the virus that causes SARS. Injected into a muscle, it instructs the     body to make a small amount of a SARS protein. The vaccine is made from just one small part     of the code for one SARS protein; a person cannot get SARS from the vaccine.      Normal volunteers between 18 and 50 years of age who are in general good health may be     eligible for this 32-week study. Candidates are screened with a physical examination and     blood and urine tests.      Participants have nine clinic visits during the study. They receive three vaccine injections,     given with a system called the Bioinjector 2000® (Registered Trademark), which delivers the     vaccine through the skin without the use of a needle. Following each injection, participants     take home a diary card, on which they record their temperature and any vaccine side effects     daily for 5 days. Participants must immediately report any symptoms to a study physician,     and, if necessary, go to the clinic for an examination. Participants have the following tests     and procedures:        -  Vaccine injections (study day 0, around week 4, and around week 8, with at least 21 days          between injections)        -  Medical history and, if needed, physical examination (study day 0 and weeks 2, 4, 6, 8,          10, 12, 24, and 32)        -  Check of vital signs and weight (study day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32)        -  Lymph node examination (day 0 and weeks 2, 4, 6, 8, 10 and 12)        -  Blood draw (study day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32)        -  Pregnancy test for women (day 0 and weeks 4, 8 and 32)        -  Urine sample (day 0 and weeks 2, 4, 6, 8, 10)   "
173108|NCT00099476|"     This study will examine whether dark chocolate affects the way patients with hypertension     (high blood pressure) respond to insulin, a hormone secreted by the pancreas that regulates     blood glucose (sugar) levels. In many people with hypertension, insulin is not as effective     in helping the body use glucose. This is called insulin resistance. Insulin also increases     blood flow into muscle by opening inactive blood vessels. Laboratory studies suggest that     eating dark chocolate may improve blood pressure. This study will determine whether dark     chocolate improves insulin resistance or changes how blood vessels react to insulin in     hypertensive people.      People between 21 and 65 years of age who have high blood pressure and are not pregnant may     be eligible for this study. Candidates are screened with a medical history, physical     examination, and blood and urine tests.      Participants refrain from eating foods containing chocolate or cocoa for 1 week and then come     to the clinic on three separate occasions 3 weeks apart for a glucose clamp test and contrast     ultrasound, described below. At the first glucose clamp test, subjects are randomly assigned     to drink either a cocoa drink with high anti-oxidant content or one with a very low content     of anti-oxidant. Each drink will be taken twice a day for 2 weeks. At the end of the 2 weeks,     they return for a second glucose clamp test. At the second test, they stop taking the cocoa     drink for 1 week and then start again for another 2 weeks. For this 2-week period, those who     were given the high anti-oxidant content cocoa drink the first 2 weeks will take the placebo,     very low anti-oxidant drink this time, and those who took the placebo will now have the high     anti-oxidant cocoa drink. After this 2 weeks of taking the cocoa drink or placebo, they then     take the third and last glucose clamp test.      Glucose clamp test: This test measures how the body responds to insulin. Subjects fast the     night before each test and do not eat until the test is over, usually in the early afternoon.     For the test, the subject lies in a bed or reclines in a chair. A needle is placed in a vein     in each arm - one for collecting blood samples and the other for infusing glucose, insulin,     and a potassium solution. Blood glucose and insulin levels are measured frequently during the     test and the rate of the glucose infusion is adjusted to keep blood glucose at the baseline     (fasting) level. Blood samples are tested for blood count, electrolytes, liver function...   "
173109|NCT00099489|"     The purpose of this study is to determine whether AVONEX (Interferon Beta-1a), when compared     to placebo, reduces the total dose of IVIg that is administered after Visit 5 and through     Visit 9 (Week 32, End of Study).   "
173110|NCT00099502|"     The purpose of this study is to determine        -  whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe,          tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms        -  whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more          efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg   "
173111|NCT00099515|"     The purpose of this study is to compare intensive and standard training for human insulin     inhalation powder in patients with type 2 diabetes.   "
173112|NCT00099528|"     The purpose of this study is to gain initial safety and efficacy data on the experimental     agent REN-1654 in patients with painful post-herpetic neuralgia (PHN).   "
173151|NCT00100048|"     This is a study that will investigate the safety and efficacy of an investigational drug in     Human immunodeficiency virus (HIV) infected patients.   "
173152|NCT00100061|"     The purpose of this study is to determine the role of cranberry-containing products in     preventing urinary tract infections (UTIs).   "
173113|NCT00099541|"     This trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell     lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV     non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is     to see if a blood test can be used to predict when cancer-related bone lesions develop. This     trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage     IV non-small cell lung cancer that cannot be treated by surgery.   "
173114|NCT00099554|"     The purpose of this study is to evaluate the proportion of Rheumatoid Arthritis (RA) subjects     achieving a good or moderate DAS28 response (EULAR28 criteria) at Week 16 with etanercept     50 mg subcutaneously (SC) once weekly in patients who have failed infliximab.   "
173115|NCT00099567|"     The purpose of this study is to determine if the metabolic syndrome is a risk factor for     cognitive decline and if this association is modified by inflammation.   "
173116|NCT00099580|"     This Phase 2, randomized, placebo-controlled, multicenter outpatient study is designed to     test the safety and tolerability of AC2592 as well as examine the effect of AC2592 on oxygen     consumption during maximal tolerated exercise in adult subjects with chronic congestive heart     failure.   "
173117|NCT00099593|"     This research is being done to look at the safety and value of a vaccine for a cancer found     in the blood and skin known as Cutaneous T-cell lymphoma (CTCL) and Sezary Syndrome.      In the laboratory, researches found that special white blood cells, called dendritic cells     (DCs), are able to stimulate the immune system (groups of cells that protect the body from     germs and diseases) in a way that helps your body fight cancer. Autologous (from your own     body) DCs will be prepared (mixed together) in the laboratory with your cancer cell (Sezary     cells) to allow your DCs to pick up parts of your Sezary cells to make the vaccine for you.   "
173118|NCT00099606|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, effect     of food, and continue exploratory research of BMS-354825 in patients with solid tumors not     responding to standard treatment, or for which no effective standard treatment exists.   "
173119|NCT00099619|"     This is a study with two treatment sequences and two treatment periods that will assess the     safety and efficacy of exenatide treatment in patients with type 2 diabetes who have     inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next     appropriate step in diabetes treatment.   "
173146|NCT00099970|"     This clinical trial is being conducted to determine tumor response and preliminary safety of     a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that     is required for the establishment of new blood vessels during tumor growth, a process known     as angiogenesis.   "
173337|NCT00110929|"     The purpose of this research is to study the efficacy and safety of AMG 073 in patients with     kidney failure who are being treated with hemodialysis or peritoneal dialysis and who also     have secondary hyperparathyroidism (HPT).   "
173120|NCT00099632|"     HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to     prevent mother-to-child transmission (MTCT) of HIV. However, SD NVP may cause NVP resistance     in the mother, potentially ruling out some treatment options in the future. The purpose of     this study is to determine which of three anti-HIV drug regimens most effectively reduces the     development of maternal NVP resistance in HIV infected pregnant women. The effectiveness of     short-term (7 day therapy) versus long-term (21-day therapy) regimens will also be compared.      The study hypotheses are: 1) intrapartum SD NVP with a 21-day course of antiretroviral     therapy (ART) results in less frequent selection of NVP-resistant HIV-1 variants than     intrapartum SD NVP with a 7-day course of ART, and 2) a 7- or 21-day course of     lamivudine/zidovudine (3TC/ZDV), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), or     lopinavir/ritonavir (LPV/r) following SD NVP will not select nucleoside reverse transcriptase     inhibitor (NRTI)- or protease inhibitor (PI)- resistant HIV-1 variants.   "
173121|NCT00099645|"     The purpose of this study is to determine the anti-HIV activity and safety of 3 different     doses of mifepristone (also known as VGX-410 and RU486) in HIV infected people.      Hypothesis: Mifepristone will be generally safe (no serious adverse effects) and well     tolerated.   "
173122|NCT00099658|"     Infection by Streptococcal pneumoniae is a common invasive bacterial infection in HIV     infected children. The purpose of this study is to determine the safety of and immune     response to a pneumococcal polysaccharide-protein conjugate vaccine (PncCV) in HIV infected     and uninfected children. The study will also determine the safety of and immune response to     Haemophilus influenzae vaccine (HibCV) in these children. Recruitment for this study will     occur at two hospitals in South Africa, and all HIV infected infants participating in this     study must also be coenrolled in the CIPRA SA-Project 2 study.   "
173123|NCT00099671|"     The purpose of this study is to determine the safety of a single, under-the-skin dose of     interleukin-7 (IL-7) in HIV infected people currently taking anti-HIV drugs.   "
173124|NCT00099684|"     Anti-HIV drugs, especially protease inhibitors (PIs), have been linked to lipid metabolism     problems, including elevations in low density lipoprotein cholesterol (LDL-c), triglycerides,     and total cholesterol. Ezetimibe is a lipid-controlling drug; statins are part of another     class of lipid-lowering drugs popularly prescribed to people with high cholesterol. The     purpose of this study is to determine the safety, effectiveness, and tolerability of     ezetimibe in combination with statin therapy in adults who are taking anti-HIV drugs and have     high cholesterol.      Study hypothesis: In HIV infected adults, ezetimibe in combination with statin therapy will     result in significantly lower LDL-c compared to statin therapy alone.   "
173125|NCT00099697|"     The purpose of this study is to determine whether DHEA replacement therapy decreases     abdominal fat and improves insulin sensitivity.   "
173126|NCT00099710|"     The purpose of this study is to examine the safety and tolerability of curcumin, and to     determine its effect on patients with mild to moderate Alzheimer's Disease (AD).   "
173153|NCT00100074|"     To assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline.   "
173154|NCT00100087|"     The study will investigate the safety and feasibility of using the TheraSight(TM)     Brachytherapy System for treatment of wet age-related macular degeneration (AMD).   "
173155|NCT00100100|"     The purpose of this study is to evaluate the efficacy and safety of modafinil in reducing     cocaine use in subjects with cocaine dependence.   "
173127|NCT00099723|"     Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the     liver. It is the most common cause of chronic liver disease in the United States. The exact     cause of NAFLD is unknown, but it is more common among people with conditions such as     adult-onset diabetes. NAFLD can strike people of all ages but most often affects adults     between the ages of 40 and 60. Research indicates that overgrowth of gut bacteria can start a     chain of biological processes that stress the liver, causing liver inflammation. Probiotics,     living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial     overgrowth and/or strengthening the gut walls. Because probiotics are generally safe,     inexpensive, and easy to tolerate they are an attractive treatment option for NAFLD.   "
173128|NCT00099736|"     The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney     transplant.   "
173129|NCT00099749|"     The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney     transplant.   "
173130|NCT00099762|"     This study will use a procedure called selective venous catheterization in patients with     tumor-induced osteomalacia (TIO) or oncogenic osteomalacia (OOM) to try to locate very small     tumors that produce proteins called phosphatonins. Too much phosphatonin in the blood causes     the kidneys to allow large amounts of phosphorus to be excreted in the urine, leading to low     blood levels of phosphorus and, in turn, to osteomalacia (a condition of soft bones).     Osteomalacia can cause bone fractures requiring many surgical procedures that can leave     patients in pain. Patients may also feel weak and can lose height from massive bone loss.     Selective venous catheterization is a way to measure the amount of phosphatonin in the blood     and may be used as a way to locate phosphatonin-producing tumors that cannot be found using     standard imaging techniques.      Patients with TIO or OOM are screened under NIDR Protocol 01-D-0184 with a medical history,     review of medical records and routine physical examination. Other procedures may include     blood tests, urine tests, and imaging tests, such as x-rays, bone densitometry, bone scan,     computed tomography (CT) and magnetic resonance imaging (MRI). This study will include mostly     patients whose tumors were not able to be located through imaging procedures, but also a few     patients whose tumors were located.      All participants, regardless of whether or not their tumor was located, undergo selective     venous catheterization. For this procedure, a radiologist inserts a catheter (thin flexible     tube) into the body and uses fluoroscopy (a type of x-ray) to guide the tip of the catheter     to different places in the body to collect small amounts of blood from the different areas.     After the procedure, the patient lies flat for 2 hours and avoids moving his or her leg on     the side where the catheter was placed.      The blood is analyzed to measure the amount phosphatonin is in each sample, and the amounts     are compared to the average amount of phosphatonin in the general blood circulation. If a     higher level of phosphatonin is found in one area and the location of the tumor is unknown,     the patient undergoes imaging in that area. If a tumor is found and it is in an area where it     can be removed surgically, the patient is given the option to have the surgery. If the tumor     is not found by imaging done after the first catheterization procedure, the patient has the     option to have a second catheterization, taking samples of blood only from the area where the     phosphatonin was found to be the highest during the sampling procedure.   "
173131|NCT00099775|"     This study will examine whether the anti-fungal drug caspofungin can prevent Candida     infections in adult patients in intensive care units (ICUs). Caspofungin is approved to treat     certain fungal infections, including fungal blood stream infections due to Candida. Because     ICU patients are at high risk for Candida, it would be beneficial to have a preventive drug,     thereby reducing complications due to infection.      Patients 18 years of age or older who are not pregnant may be enrolled in this study on day 3     or 4 of their ICU admission if they have an expected stay of at least 2 additional days in     the ICU.      Participants are randomly assigned to treatment with either caspofungin or placebo (an     inactive substance). Before treatment, patients have a medical history and physical     examination. Blood and urine tests are done for routine tests and to look for fungal     infection. Additional samples that may be collected to test for fungal infection include a     rectal swab or stool sample; a wound culture if the patient has a wound, or a sputum culture     in patients who have a tube in their throat to help with breathing or are producing sputum.      Patients take caspofungin or placebo once a day for no more than 28 days. In addition, they     undergo the following procedures:        -  Review of treatment side effects and medicines taken, daily during treatment, 1 week          after treatment, and 2 weeks after treatment        -  Physical examination once a week, on the last day of treatment, and 1 week after          treatment        -  Urine test once a week, on the last day of treatment, and 1 week after treatment to look          for possible fungal infection        -  Blood tests twice a week, on the last day of treatment, 1 week after treatment, and 2          weeks after treatment for laboratory safety tests and to look for fungal infection        -  Collection of additional samples (rectal swab or stool sample, wound culture, or sputum          sample) once a week, on the last day of treatment, and 1 week after treatment to look          for possible fungal infection   "
180224|NCT00203086|"     It is thought that treating Multiple Sclerosis with Novantrone for a short period of time     prior to treatment with Copaxone may enhance the onset effect of Copaxone.   "
173132|NCT00099788|"     MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled,     parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine     during acute and long-term treatment in approximately 5,500 patients with non-ST elevation     acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint     in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of     cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST     elevation ACS receiving standard therapy. The study also evaluates the safety of long-term     treatment with ranolazine compared to placebo.   "
173133|NCT00099801|"     The safety and efficacy of FTY720 is being evaluated in patients who receive a kidney     transplant.   "
173134|NCT00099814|"     Orthodontic treatment requires application of force systems to individual teeth or groups of     teeth, which results in a cellular response with periodontal ligament (PDL) and alveolar bone     remodeling. The forces applied must be of sufficient magnitude and duration to exceed the     normal physiologic threshold associated with daily oral function. Excessive force levels will     result in areas of tissue necrosis with delayed tooth movement and increased risk of root     resorption. Although orthodontic tooth movement is achieved in a large segment of the     population, the optimum force level has not been defined. The optimum force for tooth     movement depends on individual root geometry as well as biologic characteristics of     surrounding tissue including bone density, periodontal thickness, and fluid dynamics.      Because experimental and clinical techniques are generally limited to known complex force     systems, biomechanical modeling has become a necessity. Such models must be validated with     well-controlled clinical studies that evaluate orthodontic tooth movement over an extended     distance. The ultimate goal would be development of a computer simulation model to predict     tooth movement in the clinical setting.      The primary objective of this study is to test controlled clinical data with a biomechanical     model of the tooth and supporting tissues for distal movement of the human maxillary canine     tooth (of known root geometry) in response to various 3D force systems that produce different     levels of stress in the supporting tissues. Secondary objectives include evaluation of rate     of bodily tooth canine movement with two known compressive stress levels (13 and 22 kPa),     evaluation of three different reference systems to measure rate of tooth movement, and     evaluation of an implant placed in the roof of the mouth (palatal implant) for orthodontic     anchorage in adolescent patients.      The rate of translation (bodily) tooth movement of the maxillary canine tooth will be     significantly greater with 22kPa compared to 13kPa compressive stress applied to the     periodontal ligament, and this difference can be predicted by appropriate     mathematical/numerical models of the tooth and supporting tissues.   "
173135|NCT00099827|"     The main objective of this research project is to describe the impact of depression on     adolescent and family functioning compared to that of healthy adolescents and to understand     the impact of Feedback and Patient Activation (FPA) on teen and family decision-making     regarding seeking care for depressive disorders.   "
173156|NCT00100113|"     The purpose of this study is to assess potential interactions between intravenous (IV)     cocaine and 3 doses of GBR 12909.   "
173157|NCT00100126|"     The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in     the bacteriological outcome at the Test of Cure Visit.   "
173236|NCT00109564|"     The purpose of this Phase II study is to evaluate the efficacy and safety of ispronicline     (TC-1734-112) compared to placebo (inactive substance pill) in patients with age associated     memory impairment (AAMI). AAMI is characterized as cognitive impairment including memory loss     and poor concentration associated with aging.   "
173136|NCT00099840|"     Acute respiratory tract infections (ARTI) are among the most frequent reasons for seeking     medical attention in primary care. Although from predominantly viral origin, ARTIs are the     most important condition for the prescription of antibiotics (AB), mainly due to the     difficulty in primary care to differentiate between viral and bacterial etiology. Unnecessary     AB use increases drug expenditures, side effects and AB resistance. A novel approach is to     guide AB use by procalcitonin (ProCT), since serum levels are elevated in bacterial     infections but remain lower in viral infections and inflammatory diseases.      We aim to compare a strategy based on evidence-based guidelines with ProCT guided AB therapy     in ARTIs with respect to outcome (days with restriction) and AB use. Patients presenting with     ARTIs to primary care physicians and are intended to be treated with AB based on guidelines     will be included and randomized 1:1 either to standard management or to the ProCT guided     prescription of AB. All participating physicians will receive evidence-based guidelines for     the management of patients with ARTIs. Patients with ARTI and in need of ABs by physicians’     clinical judgment and with informed consent will be randomized to ProCT plus guidelines     (ProCT group) versus only guidelines guided AB treatment (control group). In patients     randomized to the ProCT group, the use of antibiotics will be more or less discouraged (<0.1     or <0.25 ug/L) or encouraged (>0.5 or >0.25 ug/L), respectively. A re-evaluation in patients     with ProCT (<0.1 or <0.25 ug/L) after 6 to 24 hours is mandatory. All patients will be     reassessed at day 3 and it is recommended to stop AB in the ProCT group as described above.     Structured phone interviews at days 14 and 28 will be done in all patients from both groups.   "
173137|NCT00099853|"     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a     single oral drug. The purpose of this study is to assess the safety and effectiveness of     vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to     pioglitazone in people with type 2 diabetes not at target blood glucose levels on either     pioglitazone or rosiglitazone alone.   "
173138|NCT00099866|"     The purpose of this study is to assess the safety and effectiveness of vildagliptin, an     unapproved drug, compared to metformin in lowering overall blood glucose levels in people     with type 2 diabetes who have not been previously treated with drug therapy to lower their     blood sugar.   "
173139|NCT00099879|"     The purpose of this clinical research study is to learn if BMS-275183 can shrink or slow the     growth of the cancer in subjects with non-small cell lung cancer (NSCLC). The safety of this     treatment will also be studied.   "
173140|NCT00099892|"     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a     single oral drug. The purpose of this study is to assess the safety and effectiveness of two     doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2     diabetes who are not at target blood glucose levels on metformin alone.   "
173141|NCT00099905|"     The purpose of this study is to assess the safety and effectiveness of three doses of     vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose     levels in people with type 2 diabetes who have not been previously treated with drug therapy     to lower their blood sugar.   "
173142|NCT00099918|"     The purpose of this study is to assess the safety and effectiveness of vildagliptin, an     unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people     with type 2 diabetes who have not previously been treated with drug therapy to lower their     blood sugar.   "
173143|NCT00099931|"     Many people with type 2 diabetes cannot maintain their target blood glucose levels on a     single therapy. The purpose of this study is to assess the safety and effectiveness of     vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to     insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin     alone.   "
173144|NCT00099944|"     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a     single oral drug. The purpose of this study is to assess the safety and effectiveness of two     doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when     added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a     sulfonylurea alone.   "
173147|NCT00099983|"     The purpose of this research of 400 participants is to determine whether a drug called     risperidone can decrease symptoms of Post-Traumatic Stress Disorder (PTSD). It is a     placebo-controlled study, meaning that half of the participants will be assigned to receive a     pill that contains no drug. The treatment phase of the study will last for 6 months, during     which time participants will continue to receive all their usual treatments in addition to     the study treatment and will be asked to complete procedures and assessments (questionnaires,     interviews, laboratory tests, physical exams, etc.) related to their PTSD symptoms at various     points within the 6-month treatment phase. At the end of the 6-month study, participants will     discontinue the study treatment.   "
173148|NCT00099996|"     This study will test the safety and effectiveness of 40 mg of ezetimibe (Zetia ) daily in     lowering blood levels of cholesterol and of the plant sterols sitosterol and campesterol in     patients with homozygous sitosterolemia, an inherited disorder of sterol metabolism. (Sterols     are alcohol substances found in animal and plant fats.) In this disorder, an excess of many     plant sterols is absorbed and not enough excreted. Patients can develop atherosclerosis and     coronary heart disease as early as childhood, as well as other problems including arthritis,     arthralgia, and tendon xanthomas (lipid deposits). Current treatment consists of ezetimibe 10     mg, dietary restriction of plant and shellfish sterols, and bile salt binding resins.     Ezetimibe is a cholesterol-lowering drug that inhibits intestinal absorption of cholesterol     and structurally related plant sterols across the intestinal wall.      Patients with homozygous sitosterolemia who are between 18 and 85 years of age have completed     NHLBI's 1-year study of ezetimibe at 10 mg a day may be eligible for this study.      All participants maintain their current stable diet and take a 10-mg pill of ezetimibe daily     for 26 weeks. They are also randomly selected to take either an additional 30-mg pill of     ezetimibe or a placebo (look-alike pill with no active ingredients). Patients fast for at     least 12 hours before each of 6 visits scheduled during the course of the study. At these     visits, patients undergo some or all of the following procedures for monitoring their health     and evaluating their response to treatment:        -  Medical history and review of medications        -  Physical examination        -  Measurement of vital signs (pulse rate, blood pressure, breathing rate and temperature)        -  Review of dietary maintenance        -  Measurements of height, weight, and waist circumference        -  Measurement (with ruler) and photographs of non-Achilles xanthoma        -  X-ray of Achilles tendon        -  Blood draw and urine collection        -  Pregnancy test for women of childbearing potential   "
173149|NCT00100009|"     This study will test the safety and effectiveness of combining a laser treatment called     photodynamic therapy, or PDT, with injections into the eye of the steroid triamcinolone     acetonide for treating age-related macular degeneration (AMD). The macula is the part of the     retina in the back of the eye that determines central or best vision. AMD can severely impair     central vision, affecting a person's ability to read, drive, and carry out daily activities.     This vision loss is caused by the formation of abnormal blood vessels behind the retina that     leak blood under the macula. PTD stops the growth of these blood vessels and slows the rate     of vision loss; however, it has only a temporary effect and does not work in all patients.     Furthermore, it may actually cause some swelling and re-growth of blood vessels.     Triamcinolone acetonide can help lessen swelling and scarring.      Patients 50 years of age and older with AMD may be eligible for this study. Candidates are     screened with a medical history, medical evaluation, and eye examinations (see below).     Participants are randomly assigned to one of three treatment groups: 1) PDT plus 1 mg TAC-PF;     2) PDT plus 4 mg TAC-PF; or 3) PDT plus sham injection (a syringe with no needle is pressed     against the eye). Treatments are given the day the patient enrolls in the study and then     every 3 months for 2 years, as long as the therapy is thought beneficial. Patients who must     discontinue TAC-PF injections may still be treated with PDT if medically necessary. In     addition to treatment, patients undergo the following tests and procedures:        -  Eye examination: Visual acuity and eye pressure are measured, and the lens, retina,          pupils and eye movements are examined.        -  Fundus photography: Photographs of the back of the eye are taken using a special camera          with a bright flash.        -  Lens photography: Photographs of the lens are taken to look for development of          cataracts.        -  Fluorescein angiography: Pictures of the retina are taken to look for abnormal blood          vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in          the eyes. The retina is photographed using a camera that flashes a blue light into the          eye. The pictures show if any dye has leaked from the vessels into the retina,          indicating possible blood vessel abnormality.        -  Optical coherence tomography: This test uses light to produce a 2-dimensional          cross-sectional picture of the retina. The patient looks into a machine called an          optical coherence tomograph at a pattern of flashing and rotating red and green lights,          first with one eye and then the other.        -  PDT: A needle is placed in an arm vein and a drug called verteporfin (Visudyne®          (Registered Trademark)) is infused into the vein over 10 minutes. After 15 minutes, the          eye is anesthetized with numbing drops. A special contact lens is then placed on the eye          and the laser beam is directed to the eye for 83 seconds.        -  TAC-PF or injections (for those in the TAC-PF treatment groups): Numbing and anesthetic          drops are placed on the surface of the eye before injection of TAC-PF. Another          anesthetic is then applied to the lower part of the eye with a cotton swab. After a few          minutes, TAC-PF is injected into the vitreous (jelly-like substance inside the eye).          Patients receiving sham injections undergo the identical procedure, except a syringe          with no needle is pressed against the eye to seem like a real injection. All patients          receive antibiotic drops to put in their eye for 2 days after each treatment. Patients          return to the clinic anytime from 2 to 7 days after each treatment for a check of          vision, eye pressure, and treatment side effects.      Patients are seen in the clinic for additional checks at 4 weeks and 4 months after the first     treatment.   "
173150|NCT00100035|"     The purpose of this study is to assess the effectiveness of polarity therapy (PT), a     complementary and alternative medicine treatment, in American Indian caregivers living in the     Pacific Northwest.   "
173158|NCT00100139|"     In this study, Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) is being compared to     Taxol® to examine whether the paclitaxel in these 2 formulations undergoes similar processing     by the body. Safety and tolerability of LEP-ETU and Taxol will also be assessed. In this     study, each patient will receive one intravenous infusion of LEP-ETU or Taxol, followed 3     weeks later by an infusion of the other drug, at the same dose and infusion duration.     Multiple blood samples will be taken for analysis before, during, and after both drug     infusions. Upon completing these 2 Cycles of treatment, eligible patients may enroll in an     extension study (LEP-ETU-102B) to continue treatment with LEP-ETU.      LEP-ETU is a liposomal formulation of paclitaxel, a widely used anti-cancer drug. This     LEP-ETU formulation of paclitaxel is being developed to potentially reduce toxicities     associated with Taxol, by eliminating the drug formulation component polyoxyethylated castor     oil (Cremophor® EL). In LEP-ETU, paclitaxel is associated with liposomes, which are     microscopic membrane-like structures created from lipids (fats). Thus, the LEP-ETU     formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy.   "
173159|NCT00100152|"     A Notch signalling pathway inhibitor study in pediatric and adult patients with relapsed     (worsening) or refractory (not responding to treatment) T-cell acute lymphoblastic     leukemia/lymphoma (T-ALL).   "
173160|NCT00100165|"     The study hypothesis is that 3-2,4 dimethoxybenzylidene anabaseine (DMXB-A), an orally     administered nicotinic cholinergic agonist, will improve attention and other     neuropsychological dysfunctions in schizophrenia, leading to improved psychosocial outcome.   "
173161|NCT00100178|"     The objective of this study is to identify immune intervention strategies that will preserve     residual beta cell function at the onset of type 1 diabetes. Scientific evidence developed     over the last 10 - 20 years suggests that type 1 diabetes is a chronic, slowly progressive     autoimmune disease and that clinical symptoms do not develop until at least 80% - 90% of beta     cell mass has been destroyed as a result of the autoimmune process. It is now recognized that     preservation of remaining beta cells is clinically important as the ability to secrete, even     small amounts of insulin, can make the disease easier to control and help minimize     complications associated with having years of inadequate glycemic control.      This clinical trial is the first in a series of studies to be launched by the TrialNet Study     Group to test various interventions for preserving residual beta cell function in new onset     type 1 diabetes. Specifically, this study is designed to determine the ability of     Mycophenolate Mofetil (MMF/CellCept) used alone, or in combination with Daclizumab     (DZB/Zenapax) to see if it is possible to stop the immune system from destroying beta cells     in new onset type 1 diabetes patients (within 3 months of diagnosis.)      Researchers have made great strides in understanding how the immune system works and in     changing the activity of immune cells with medicines called immunotherapies. Some     immunotherapies work by making the immune system less active. Scientists have discovered that     key immune cells, called T cells, help to cause type 1 diabetes. These T cells are largely     responsible for attacking the beta cells that produce insulin. Doctors have found medicines     that slow or suppress the activity of T cells. It is hoped that these immunosuppressive     medicines can help treat type 1 diabetes by stopping T cells before they destroy all of the     beta cells.      Medicines that make the immune system less active have been developed and studied for other     diseases. Mycophenolate mofetil (MMF) and Daclizumab (DZB) are two of these medicines. Their     effects on the immune system are well understood. Researchers believe these medicines may     lessen the immune system's destruction of beta cells that leads to type 1 diabetes. In     addition, researchers hope the effect of these medicines will last longer than other     therapies.      The goal of this study is to find out if two medicines are able to stop the ongoing     destruction of beta cells which are still functioning at the time type 1 diabetes is     diagnosed. The two immunosuppressive medications being tested are Mycophenolate mofetil     (MMF/CellCept®) and Daclizumab (DZB/Zenapax®). They work by making the immune system less     active. TrialNet researchers hope that these medications will help maintain insulin secretion     from remaining beta cells and thus help to maintain better glycemic control. Even if the     medications work, study participants will still need to take insulin injections but it may     make it easier to control normal blood sugar levels which can help reduce long-term     complications of diabetes such as blindness, kidney failure, nerve damage, heart attack and     stroke.      The aim is to arrest beta cell destruction in newly diabetic subjects because immune     modulation may not work well alone once the autoimmune process has progressed to complete or     near complete destruction of beta cells. The study's rationale is to demonstrate a meaningful     preservation of islet function with minimal immune system side effects over the 4-year course     of this study.      The data from this clinical trial could serve as the basis for a larger trial if the results     are sufficiently positive, or they could suggest other combined intervention trials that     might achieve either better efficacy or potentially preserve C-peptide without the need for     continued immunosuppression.   "
173162|NCT00100191|"     The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization     (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE     was considered equivalent to hysterectomy when at least 75% of patients had normalization of     heavy menstrual blood loss after treatment.   "
173163|NCT00100204|"     This study will examine saliva samples from healthy volunteers and patients with various     diseases to learn more about how disease affects the mouth and salivary glands. It will use a     method called salivary proteomics to identify multiple proteins in saliva and discover if     there are protein patterns unique to specific diseases. The study will:        -  Characterize the salivary proteome in patients with Sjogren's syndrome,          graft-versus-host disease, diabetes, sarcoidosis, cystinosis, dental caries, and          immunodeficiencies and in patients who have had head and neck radiation        -  Evaluate the possible use of salivary proteomics for early diagnosis        -  Evaluate the potential use of salivary proteomics for prognosis and treatment      Patients participating in NIH clinical studies who have Sjogren's syndrome, graft-versus-host     disease, diabetes, sarcoidosis, cystinosis, dental caries, or an immunodeficiency, or     patients undergoing head and neck radiation may be eligible for this study. Candidates are     screened with a medical and dental history, head and neck examination, and photographs of any     mouth sores or disease. Healthy volunteers also have blood drawn for routine laboratory     testing.      Participants have saliva collected from the floor of the mouth, the parotid salivary glands     in the cheek, and the submandibular and sublingual salivary glands under the tongue. Patients     with certain diseases also provide a urine sample. Saliva samples are collected as follows:        -  One time from healthy volunteers and patients with Sjogren's syndrome, diabetes,          sarcoidosis, cystinosis and immunodeficiencies        -  Five times from patients undergoing stem cell transplant: at baseline before transplant          and about 1, 2, 3 and 6 months after transplant.        -  Three times from patients undergoing head and neck radiation: at baseline before          radiation and at 3 and 6 months after the conclusion of radiation.   "
173338|NCT00110942|"     The purpose of this study is to evaluate the clinical benefit (change in Western Ontario and     McMaster University Osteoarthritis Index [WOMAC] pain score) of AMG 108 (300 mg     subcutaneously [SC] every 4 weeks) in subjects with OA.   "
173164|NCT00100217|"     This study provides training opportunities for critical care specialists in evaluating and     treating critically ill patients. Patients enrolled in the study receive standard tests and     treatments. The study objectives are to:        -  Provide additional training for staff of the NIH Clinical Center intensive care unit,          including physicians, nurses, fellows, and other trainees so that they develop and          maintain essential skills,        -  Gather information about the natural history and outcomes of critical illness,          accompanying conditions, and complications,        -  Develop hypotheses about the medical problems involved in the illnesses and their          treatment, and        -  Identify critically ill patients who may be eligible for specific NIH research          protocols.      Critically ill patients 18 years of age and older who may benefit by transferring to the NIH     Clinical Center for treatment may be eligible for this study. Patients will be transferred to     the Clinical Center from another hospital only when the referring and accepting physicians in     both institutions agree that the potential benefit of coming to the NIH outweighs the risk of     transferring the patient.      Participants are evaluated and treated at the Clinical Center. Patients provide a medical     history and have a physical examination. They may also have various medical tests and     procedures needed to evaluate their condition. These procedures may include blood work,     placement of an intravenous (IV) line, x-rays and other imaging tests such as computed     tomography (CT) or magnetic resonance imaging (MRI) and other procedures.      Patients who are diagnosed with a specific condition may be offered treatment or may be     referred to another study that is more appropriate for that particular problem.   "
173165|NCT00100230|"     Purpose:      Retinitis pigmentosa (RP) is characterized by progressive loss of visual function due to     specific genetic mutations. This trial is focused on patients with one of the most severe     forms of the disease, X-linked inherited RP (XLRP). This disease is characterized by early     onset (typically loss of night vision as a child) followed by loss of peripheral vision as a     teenager and young adult. There is no male-to-male transmission of the disease in the family.      There is no cure for RP and treatment options are limited. Two clinical trials have not found     a benefit from nutritional supplementation with the long-chain polyunsaturated fatty acid,     docosahexaenoic acid (DHA), at low daily doses although there is evidence that it slows     disease progression in certain instances. In this clinical trial, we propose that a high dose     nutritional DHA supplement will slow the loss of visual function and preserve usable vision     in patients with XLRP.      This study is a 4-year placebo-controlled randomized clinical trial meaning that patients     have a 50-50 chance of receiving placebo or experimental treatment. A total of 66 patients     will be enrolled; 33 will receive placebo and 33 will receive the treatment. Entry criteria     include diagnosis of XLRP by an ophthalmologist, age 7 to 32 years, male, sufficient visual     function such that disease progression can be followed for the entire duration of the trial,     and a willingness to visit the testing site (Dallas, TX) once a year.      Annual visual function testing includes ETDRS visual acuity, full-field and multifocal     electroretinography (ERG), static peripheral visual fields, and fundus photography. Cone ERG     function is the primary outcome measure.      Funding Source - FDA, Foundation Fighting Blindness, DSM Nutritionals   "
183468|NCT00245336|"     The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is     effective in stopping bleeding during surgery, in comparison with bovine thrombin.   "
173166|NCT00100243|"     This is a Phase 2, open-label study in subjects with androgen-independent prostate cancer who     have progressed following treatment with an LHRH agonist. Up to 22 subjects will be enrolled.     Enrollment will be monitored to ensure that not all subjects are enrolled based on rising     prostate specific antigen (PSA) criterion only.      Subjects will be treated with abarelix (Plenaxis) 100 mg intramuscularly (IM) every 2 weeks     for 12 weeks (total dose of 600 mg).   "
173167|NCT00100256|"     The purpose of this study is to determine the maximum dose that is safely tolerated of the     experimental drug Rhenium Re 188 P2045. This will be done by first treating patients at     relatively low doses of Rhenium Re 188 P2045, observing them closely to assure that there are     no bad side effects, then increasing the dose when we are confident that it is safe to do so.   "
173168|NCT00100269|"     Oxidative stress related damage to sperm is believed to be a major cause of male infertility.     The object of the Menevit study is to investigate the role of a novel anti-oxidant     preparation (Menevit) on sperm function, embryo quality and pregnancy rates in an in vitro     fertilization (IVF) setting.   "
173169|NCT00100282|"     This is a multi-center, double-blind, inpatient study followed by outpatient,     placebo-controlled, single-dose, dose-escalation evaluation of the safety and tolerability of     PPI-1019 in patients with mild-moderate Alzheimer’s disease (AD). Up to 12 sequential cohorts     of 8 patients (6 active and 2 placebo) will be given a single PPI-1019 dose intravenously     (IV) over 1 minute in order to determine a maximum tolerated dose (MTD). The MTD will be the     dose immediately below the not-tolerated dose.   "
173170|NCT00100295|"     The purpose of this study is to determine the safety and effectiveness of an herbal product     for the treatment of attention deficit hyperactivity disorder (ADHD) in children and     adolescents.   "
173171|NCT00100308|"     The purpose of this study is to determine whether low dose continuous infusion of     unfractioned heparin (500 units/hour), in addition to the standard treatment, is efficacious     as complementary therapy for sepsis patients.   "
173172|NCT00100321|"     This study will examine pancreatic tumor tissue and immune cells from patients with a     pancreatic tumor to look for markers on these cells that may be useful in developing new     treatments for the disease.      Patients 16 years of age and older with any evidence of a primary pancreatic tumor that can     be surgically removed may be eligible for this study. Types of pancreatic tumors included in     this trial are pancreatic cancer, adenosquamous carcinoma, anaplastic carcinoma, IPMN     (intraductal pancreatic mucinous neoplasm), acinar cell carcinoma, pancreaticoblastoma,     mucinous cystic neoplasms, serous cystic neoplasms, solid-pseudopapillary cystic neoplasms,     squamous cell carcinoma, Vater (ampullary tumors) duodenal adenoma or cancer and common bile     duct tumors (cholangiocarcinoma.) The specific type of tumor does not have to be determined     before the operation. Candidates are screened with a medical history and physical     examination, computed tomography (CT) or magnetic resonance imaging (MRI) of the chest,     abdomen, and pelvis, blood and urine tests, and an electrocardiogram. Patients older than 50     years of age and patients with a history of cardiovascular disease may also have a thallium     cardiac stress test.      Participants undergo standard treatment for their pancreatic tumor, including surgery to     remove the tumor. Before, during, and after the operation, several blood samples are drawn as     part of routine patient care and for research tests. During the surgery, a small piece of     tumor tissue is taken for examination under the microscope and to grow cells in the     laboratory for tumor and immune cell studies. Some patients may undergo leukapheresis to     collect large numbers of white blood cells for study. For this procedure, blood is collected     through a needle in an arm vein and flows through a catheter (plastic tube) into a machine     that separates it into its components by centrifugation (spinning). The white cells are     extracted and the rest of the blood (plasma, red cells, and platelets) is returned through     another needle in the other arm.      Patients who require additional treatment, such as chemotherapy or radiation, may be treated     at NIH on another protocol or referred for appropriate treatment elsewhere.   "
173173|NCT00100334|"     This is a single-center, double-blind, inpatient study followed by an outpatient,     placebo-controlled, multiple-IV injection evaluation of the safety and tolerability of     PPI-1019 in subjects with mild-moderate Alzheimer’s disease (AD). The primary objective of     the study is to assess the safety of multiple IV injections of PPI-1019 in subjects with     mild-moderate Alzheimer’s disease.   "
173174|NCT00100347|"     The purpose of this multi-center, open-label, escalating dose study is to assess the safety     and tolerability of PPI-2458 in subjects with Non-Hodgkin's Lymphoma (NHL)and solid tumors.     Subjects will be treated every other day (QOD) with PPI-2458 while being monitored closely     for adverse events.   "
173175|NCT00100360|"     This study will explore possible hormonal causes of menstrual-related mood disorders (MRMD)     by stopping the menstrual cycle with a drug called Lupron and then giving in sequence two     menstrual cycle hormones, progesterone and estrogen. The study will first evaluate Lupron's     effectiveness in treating MRMD and will then examine the effects of giving estrogen and     progesterone on mood and behavior. In addition, positron emission tomography (PET) and     magnetic resonance imaging (MRI) will be used to study serotonin receptors and transporters -     molecules in the brain that are thought to play a major role in mood changes related to the     menstrual cycle.      Menstruating women between 18 and 50 years of age who are in good health, not pregnant, and     not taking medications may be eligible for this study. Women with MRMD must have had at least     moderately severe MRMD or behavioral disturbances for at least 6 months within 2 years of     entering the study. Healthy controls must have no history of MRMD or behavioral disturbances.     Candidates undergo physical and neurological examinations, chest x-ray, electrocardiogram,     and blood and urine tests. Results of a recent Pap smear (no longer than 12 months before     beginning the study) must be available.      Participants undergo the following tests and procedures:        -  Drug treatment: Lupron is injected into a muscle once a month for 5 months. After the          second month, participants receive estrogen or progesterone, or both, daily. Estrogen is          delivered through a skin patch (20 micrograms per day) and the progesterone is taken as          a rectal or vaginal suppository twice a day for the remaining 12 weeks of the study.          Every day, all participants wear a skin patch and insert two suppositories, but at some          point during the 12 weeks, active medication is replaced with placebo to allow the drugs          to wash out of the body.        -  Physical examination and blood draw: A physical examination and blood tests are done at          the start of the study and several times during the study to assess general health,          evaluate liver and kidney function, and measure blood cell counts.        -  Response to treatment drugs: Responses to Lupron, estrogen, and progesterone are          evaluated periodically with interviews and symptoms self-rating scales. Control subjects          also take paper and pencil psychological tests.        -  PET imaging: A total of six PET scans are done at three time points during hormone          treatment. PET uses small amounts of a radioactive chemical called a tracer that          labels active areas of the brain. For the procedure, the subject lies on the scanner          bed. A special mask is fitted to the head and attached to the bed to help keep the          subject's head still during the scan so the images will be clear. A brief scan is done          just before the radioactive tracer is injected to help in analyzing the PET data. After          the tracer is injected through a catheter (plastic tube) placed in the arm, pictures are          taken for about 2 hours, during which the subject lies still on the scanner bed.        -  MRI scan: MRI uses a magnetic field and radio waves to produce images of body tissues          and organs. For this procedure, the patient lies on a table that is moved into the          scanner (a narrow cylinder) and wears earplugs to muffle loud knocking and thumping          sounds that occur during the scanning process. The procedure lasts about 1 hour.   "
173176|NCT00100373|"     The purpose of this study is to measure the immune response (how the body fights infection)     to an experimental preparation of live Respiratory Syncytial Virus (RSV). A better     understanding of this virus may be useful in development of vaccines and treatments.     Participants will include 20 healthy adults age 21-40. Study procedures will include drawing     blood, urine samples, respiratory exams, vital signs and temperature, diary cards, nasal     mucus weight and nasal washes and swabs. All participants will receive vaccine via nose     drops. Patients will participate in the study for about 2 months.   "
173177|NCT00100386|"     Primary Outcome Measures:Incidence density of colonization with MRSA or VRE (number of new     colonization events per 1000 patient days at risk) during the intervention phase. Secondary     Outcome Measures:The effect of the 2 strategies on the incidence density of colonization with     MRSA and VRE individually will be determined and compared descriptively. The effect of the     strategies on the cumulative incidence of bacteremia caused by MRSA and VRE will be     determined to assess the clinical relevance of the strategy in preventing infection. The     trial will evaluate the frequency of hand hygiene and the use of gloves and gowns by     healthcare workers to substantiate whether the effect of the intensive control strategy is     mediated, as expected, by an increase in the use of gloves and gowns due to an increase in     the number of patients cared for using Contact Precautions.   "
173178|NCT00100399|"     The purpose of this study is to test the immune response caused by investigational Fluarix     vaccine in healthy people aged between 18-64 years in the U.S.A. Up to 1050 volunteers at 4     centers will receive Fluarix or Placebo (saline), and their responses will then be compared.     Subjects will be placed by age into 2 groups (18 to 49 years old and 50 to 64 years old),     then randomly assigned to receive a dose of Fluarix or Placebo by injection into a muscle.     There will be 2 phases in this study: (1) the active study phase (2 visits) for all subjects;     and (2) the cross-over phase, only for subjects enrolled in the placebo group who accept to     receive Fluarix. Blood samples will be obtained in order to measure immune response to the     vaccine. On the day of vaccination, volunteers will receive a diary card to record     information on symptoms experienced during the next 3 days. Subject participation in either     group will be up to 2 months.   "
173251|NCT00109772|"     The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the     efficacy and safety of Lenalidomide in adult subjects with Complex Regional Pain Syndrome     (CRPS) Type 1.   "
173179|NCT00100412|"     This research project is a follow-up to the prior VA-funded study that found that chronic     fatigue reported by many Gulf War veterans may be a symptom of dysfunctional cardiovascular     stress response regulation. Specifically, ill veterans had diminished autonomic responses     during demanding psychosocial tasks involving high level cognitive processing and emotional     stress. There was a close relationship between clinical status of ill veterans and their     inability to mount an appropriate physiological response under stress. The main objective of     the present investigation is to determine the specific mechanism through which this     abnormality may contribute to Gulf War-related chronic fatigue. We also observed that Gulf     veterans with posttraumatic stress disorder (PTSD) had the most dampened autonomic activation     to stressors involving higher brain activities. The second major focus of this study is to     explore the role of a psychiatric disorder, specifically PTSD, as a factor in abnormalities     in stress response regulation. This aspect of the study may also provide pertinent     information as to the role of stress of military deployment as a contributing factor in     post-Gulf War illnesses.   "
173180|NCT00100425|"     The purpose of this study is to provide new information and to determine which kinds of     brief, tolerable, experimental pain are affected by the drugs being studied in patients with     irritable bowel syndrome, a disease that causes chronic abdominal pain. The effects of     dextromethorphan, naloxone, and fentanyl on experimental pain stimuli will be tested in these     studies to better understand what causes irritable bowel syndrome.   "
173181|NCT00100438|"     This is a database study. Medical records will be reviewed in order to document a new or     pending diagnosis of Parkinson's disease and in order to learn more about the disease     process. Other than the time that it takes to complete a medical record authorization form,     no other human subject participation will be needed.   "
173182|NCT00100451|"     The purpose of this study is to determine whether exercise alters the way in which the body     stores and breaks down fat. A second objective is to evaluate how these effects are     influenced by your age and gender. These studies are important because aging, male gender,     and menopause are associated with an increased storage of abdominal fat which is frequently     accompanied by diabetes, a high blood cholesterol level, high blood pressure and greater     risks of heart attack, stroke, and death. Increasing evidence suggests that these     abnormalities and many other effects of aging may be partly due to lack of exercise.   "
173183|NCT00100464|"     The purpose of this study is to determine if a certain medication, alone or combined with     another medication, will increase muscle activity in the upper airway in people who do and     people who do not have sleep apnea. The medications being studied are paroxetine, a commonly     used antidepressant, and 5 hydroxy-tryptophan (5HTP), which also can be used as a dietary     supplement without a prescription. Because the effects of paroxetine in previous studies were     not very large, we will also study it combined with 5HTP to see if the effect on the upper     airway muscles is greater.   "
173184|NCT00100477|"     The purpose of this study is to identify the highest tolerated doses in drugs used to treat     aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy     treatment. The drugs being used in this study include drugs frequently used in treating such     diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be     effective (topotecan).   "
173245|NCT00109681|"     The primary purpose of this study is to determine whether iloprost inhalation solution is     safe in subjects with idiopathic pulmonary fibrosis (IPF) and elevated pulmonary arterial     pressure. The secondary purpose is to evaluate the effectiveness of this treatment in     subjects with this disease.   "
173185|NCT00100490|"     This is a study investigating immune function and relationships to the     hypothalamic-pituitary-adrenal (HPA) axis in Post-traumatic stress disorder (PTSD) compared     to controls without PTSD. The study involves 99 adult veterans and civilian subjects over a 3     year period. The study involves measuring immune and neuroendocrine parameters from blood     samples obtained before and after a dexamethasone suppression test. The aim of the study is     to determine whether immune alterations exist in PTSD and whether the immune-HPA axis     interactions in this disorder are different from non-PTSD subjects with the future aim of     studying whether immune dysregulation in PTSD may be linked to the increased risk for medical     and psychiatric comorbidity in this population.   "
173186|NCT00100503|"     This study will examine how therapy changes the way the brain controls movements in children     with cerebral palsy. Normally, one side of the brain controls movements in the opposite side     of the body. In cerebral palsy, however, this pattern may be different, with one side of the     brain controlling movements on the same side of the body. This study will use magnetic     resonance imaging (MRI) and transcranial magnetic stimulation (TMS) to study brain function     in children with cerebral palsy before and after therapy.      Children between 9 and 17 years of age with spastic hemiplegia type cerebral palsy will be     recruited for this study from the National Rehabilitation Hospital and Georgetown University     Center Medical Center in Washington, D.C., and the Sparks Center at UAB in Alabama. In     addition, five healthy control children will be recruited from community groups, such as Cub     Scouts, Brownies, and schools. Candidates are screened with a review of medical records and     neurological and physical examinations.      Healthy controls undergo MRI (described below) twice, 3 weeks apart. Children with cerebral     palsy undergo the following tests and procedures:        1. Rehabilitation evaluation at the NIH Clinical Center Rehabilitation Medicine Department.        2. MRI: For this test, the child lies on a table that slides in and out of the MRI          scanner-a metal cylinder surrounded by a strong magnetic field. He or she wears earplugs          to muffle loud knocking sounds that occur during scanning. Images are obtained while the          child performs simple finger tapping movements.        3. Movement Testing:             1. Finger tapping: The child taps buttons on a box hooked up to a computer             2. Muscle reflex measurements: One method uses a small motor that makes the child's               fingers move with sudden, small movements; a second method uses small shocks to the               finger or wrist. The shocks feel like a buzz; most are gentle, but some might feel               stronger.        4. TMS: This procedure maps brain function. A wire coil is held on the scalp, and a brief          electrical current is passed through the coil, creating a magnetic pulse that stimulates          the brain. During the stimulation, the child may be asked to perform simple movements..          The stimulation may cause a twitch in muscles of the face, arm, or leg, and the child          may hear a click and feel a pulling sensation on the skin under the coil.        5. Therapy: After these tests, children are randomly selected to receive either standard          therapy (neurodevelopmental treatment) or constraint-induced therapy, as follows:             1. Neurodevelopmental therapy uses principles of movement science to enhance the               child's capacity to function. The child receives therapy a few times a week for 3               weeks.             2. Constraint-induced therapy uses a combination of motor learning method and               constraint to teach the new motor skills in the child's affected hand. Children               treated with this therapy must live near a special treatment center in Alabama for               the 3 weeks of treatment. The child's good arm is constrained with a bivalve,               removable cast. The cast is placed before therapy starts and remains in place               except when the therapist removes it once a day to examine the good arm. With the               cast on, children are encouraged to use their affected hand in new ways. The               therapist then uses the motor learning method, building motor programs as a result               of practice, to teach them new skills. Motor learning therapy is 6 hours a day.        6. Post-treatment testing: After treatment, children undergo repeat rehabilitation          assessment, MRI, TMS, and movement testing.   "
173187|NCT00100516|"     This study will evaluate the differences between open surgical kidney donation and     laparoscopic kidney donation on kidney donors and recipients. Both procedures are standard     surgeries used to remove kidneys for donation, and they are done equally often. Open surgical     kidney donation involves removing the donor kidney through a 3- to 5-inch surgical incision.     Laparoscopic donation involves making several small holes in the skin and removing the kidney     through a larger hole, while directly watching the kidney with a camera. The study will     correlate the effects of both procedures with donor and recipient kidney function, urine     output, post-operative pain, and return to work after surgery.      Adults without kidney disease who are willing to donate a kidney to a patient enrolled in a     clinical transplant protocol at the NIH Clinical Center may be eligible for this study.     Donors and recipients must be enrolled in the NIDDK protocol, Live Donor Renal Donation for     Allotransplantation (protocol #99-DK-0107).      Donors and patients undergo the following procedures:        -  Infrared imaging (measurement of small differences in temperature using a special          camera) during surgery to look at blood flow to the kidney during the operation (both          donor and recipient surgical procedures). The pictures provide images of the blood          vessels in the kidney and measure how the blood flow changes.        -  Kidney biopsy (removal of a small piece of kidney tissue). The patient's failed kidney          is biopsied once during transplant surgery when it is removed. The donor's kidney is          biopsied twice - once during surgery to remove the organ from the donor and again after          transplant into the recipient.        -  Evaluations after surgery of post-operative urine output, blood pressure, and pain, and          length of hospital stay and return to work.   "
173201|NCT00106548|"     This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and     symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in     patients with moderate to severe active rheumatoid arthritis (RA) who currently have an     inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv,     tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive     methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the     target sample size is 500+ individuals.   "
173202|NCT00106561|"     The purpose of this study is to determine which combination of the tablets ramipril,     irbesartan or spironolactone is best to lower protein leakage from the kidney.   "
173252|NCT00109785|"     RATIONALE: Imaging procedures such as PET scans may improve the ability to monitor the     effectiveness of chemotherapy for locally advanced breast cancer.      PURPOSE: This clinical trial is studying how well PET scans work in patients with locally     advanced breast cancer who will undergo chemotherapy.   "
173188|NCT00100529|"     This study will use stereo photogrammetry to: 1) characterize facial features of genetic and     congenital malformations; 2) define facial features associated with normal growth and     development; and 3) determine if stereo photogrammetry soft tissue imaging can be used to     help diagnose head and facial malformations. These abnormalities currently are diagnosed     using 2- or 3-dimensional skeletal images obtained with x-rays. Stereo photogrammetry uses a     camera and computer to generate 3-dimensional images of the soft tissues of the face. Because     the method does not use any radiation, images can be taken repeatedly to evaluate patients     over a long term.      Using stereo photogrammetry, images of people who belong to a defined group, for example,     17-year-old Caucasian males, can be combined (or morphed) into one image, allowing     measurement of the facial features of the group. Comparing the morphed images of a normal     control group with those of people with specific genetic conditions may reveal distinctions     that could be used in diagnosing conditions that are currently diagnosed using x-rays.      Healthy normal volunteers and patients with craniofacial dysmorphologies may be eligible for     this study. Patients are recruited from current NIH studies of various genetic diseases.     People who have previously had head and neck surgeries, including cosmetic surgery, may not     participate.      Participants give a medical and dental history, including any orthodontic work or facial     surgeries. They are then positioned in front of a photogrammetry camera, a headband is placed     on their head, and their picture is taken. A coded patient number is entered into the     computer, where the image is stored until further analysis. Most participants are evaluated     one time, but some patients and control subjects may be asked to return yearly for repeat     images.   "
173189|NCT00100542|"     The purpose of this study is to determine whether HIV and anti-HIV drugs cause mental health     problems or make mental health problems worse in children and adolescents who were infected     with HIV at birth.   "
173190|NCT00100555|"     The purpose of this trial is to study the clinical safety, tolerability, and efficacy of     zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.   "
173191|NCT00100568|"     The purpose of this study is to determine the safety and effectiveness of the anti-HIV drugs     efavirenz and lamivudine/zidovudine given to treatment-naive HIV-infected people in Dakar,     Senegal.   "
173192|NCT00100581|"     A significant proportion of HIV infected people in the U.S. are also infected with hepatitis     C virus (HCV). The purpose of this study is to determine the effects of anti-HIV therapy on     treatment of HCV with pegylated interferon alfa-2a and ribavirin (PEG/RBV).   "
173193|NCT00106431|"     GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted     at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the     efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma     (CTCL). Study patients (pts) received romidepsin in a dose of 14 mg/m^2 intravenously over 4     hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles     although pts who showed an objective response or stable disease could continue to receive     therapy, at the discretion of the investigator, until disease progression or another     withdrawal criterion was met.   "
173194|NCT00106457|"     To understand the complex, longitudinal relations between physical fitness, physical     activity, body mass and composition and fat distribution, and genetic factors and their     independent or interactive effects on the development of obesity, the metabolic syndrome, and     sub-clinical cardiovascular disease.   "
173195|NCT00106470|"     The purpose of this study is to examine genetic factors that influence the development of     chronic obstructive pulmonary disease (COPD) in Hispanics, a minority group at high risk for     the disease.   "
173196|NCT00106483|"     To test the primary hypothesis that individuals with pre-clinical connective tissue disease     related autoimmunity are more likely to demonstrate subsequent development of sub-clinical     coronary artery disease.   "
173197|NCT00106496|"     The purpose of the study is to determine the impact of topical corticosteroids on the safety     and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe     Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo     in the long-term management of Atopic Dermatitis   "
173198|NCT00106509|"     Approximately 520 patients will be entered into this study taking place throughout the US and     Canada. This study aims to determine if an investigational drug is safe and effective for     treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat     episodes of CDAD. The investigational drug will be evaluated in comparison to current     standard antibiotic treatment, so all patients will receive active medication. All study     related care is provided including doctor visits, physical exams, laboratory tests and study     medication. Total length of participation is approximately 6 weeks.   "
173199|NCT00106522|"     This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and     symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients     with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who     have had an inadequate response to prior therapy with an anti-tumor necrosis factor     (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab     8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate     10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample     size is 500+ individuals.   "
173200|NCT00106535|"     This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs     and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in     combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid     arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg     IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week.     The anticipated time on study treatment is 1-2 years and the target sample size is 500+     individuals. After completion of the 2 year study participants could participate in the     optional 3 year open label extension phase (year 3 to 5).   "
173253|NCT00109798|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide and topotecan, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving temozolomide together with topotecan     works in treating patients with primary CNS lymphoma.   "
173203|NCT00106574|"     This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and     symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying     Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid     arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be     randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with     stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target     sample size is 500+ individuals.   "
173204|NCT00106587|"     The PACCOCATH ISR study is a randomized, double-blinded German multicenter trial on the     efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent     restenosis.   "
173205|NCT00106600|"     The goal of this study is to find the safest dose of Pixantrone (BBR 2778) that can be given     to patients with Acute Myelogenous Leukemia (AML). After the safest dose is found, up to an     additional 86 patients will be enrolled. During this part of the study, the safety and     effectiveness will be evaluated.   "
173206|NCT00106613|"     The purpose of this study is to evaluate the activity of FK228 in metastatic renal cell     carcinoma (RCC) patients who have developed progressive disease (PD) following or during     treatment with immunotherapy.   "
173207|NCT00106626|"     The purpose of this investigational study is to determine the safety and tolerability of oral     suberoylanilide hydroxamic acid when administered in combination with standard doses of     pemetrexed and cisplatin for the treatment of advanced solid tumors.   "
173208|NCT00106639|"     This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of     CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with     basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant     patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had     completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the     same treatment groups.   "
173209|NCT00106652|"     The purpose of this study is to understand how genes, environment, and the interplay between     the two, influences the development of autism and other neurodevelopmental disorders.   "
173210|NCT00106665|"     This study seeks to define the morbidity of critical care polyneuropathy and to confirm that     this diagnosis is, in fact, independently associated with increased mortality. Secondary     information regarding the reasons for ICU readmission in patients with weakness may help in     formulating cogent discharge strategies for these patients. Measurement of weakness using     handgrip strength may provide a useful surrogate marker for weakness that may be more easily     and uniformly applied.      Primary hypothesis:        -  The development of ICU-associated weakness is independently associated with excess          attributable mortality.      Secondary hypothesis:        -  The development of ICU-associated weakness is associated with an increased need for ICU          readmission.        -  Readmission to the ICU will be a result of the development of recurrent respiratory          failure or insufficiency        -  Handgrip strength testing will detect ICU-associated weakness with an equivalent          sensitivity as the comprehensive bedside muscle strength exam.   "
173211|NCT00106678|"     A number of factors influence HIV-positive adolescents' acceptance of and willingness to     continue taking anti-HIV medicines. These factors include mental health and substance abuse     issues, barriers such as lack of medical insurance, and cognitive-behavioral barriers (such     as a person's impression of the impact of the medicines on his/her health and a person's     sense of his/her ability to continue taking the medications prescribed). The purpose of this     study is to use a survey to determine how common specific barriers are that prevent HIV     positive adolescents from taking their anti-HIV medicines and if those barriers cluster     together. The information collected will be used to develop and validate a schema for     classifying HIV medication adherence by barriers to adherence or clusters of barriers to     adherence. This classification schema could then be used in the development of interventions     that better meet the needs of HIV-infected youth.   "
173212|NCT00106691|"     The purpose of this study is to determine if toremifene citrate is effective and safe in the     prevention of prostate cancer in men who have been diagnosed with high grade prostatic     intraepithelial neoplasia (PIN).   "
173213|NCT00106704|"     The purpose of this clinical study is to determine the safety and efficacy of an     investigational drug in patients with Type 2 diabetes mellitus.   "
173214|NCT00106717|"     Narrative medicine addresses the therapeutic benefits that derive from patients forming and     telling their personal stories. It offers an innovative model for improving health outcomes.     When a patient with cancer and marked suffering writes a narrative of what he or she is going     through, this process may reduce pain and improve quality of life.      Therefore, we seek to evaluate the effectiveness of writing a narrative on pain intensity and     health related quality of life.      We propose a randomized single blind (evaluator) controlled trial. Patients with cancer pain     of intensity at least 5/10 with a minimum Karnofsky score of 50% will be randomized into     three groups: 1. Narrative group. Patients will write a story about their illness for at     least 20 minutes once a week for 3 weeks; 2. Writing-control group. Patients will fill a pain     diary once a week for three weeks; 3. Control group. Subjects will not write/fill anything.     Pain will be evaluated using the numerical scale before randomization and then weekly for 8     weeks. We will also evaluate how pain interferes with general activity, mood, work, relation     with others, sleep, and enjoyment of life using the Brief Pain Inventory. As secondary     outcomes, we will evaluate health related quality of life, with the treatment outcomes of     pain survey, which is a modification of the SF 36 (short form health survey), and a global     measure of well-being before randomization, and then at 4 and 8 weeks. We will also evaluate     the emotional disclosure of the narratives.      We will use an intention to treat analysis. To analyze the effect of the treatment on pain     intensity, quality of life, and well-being, we will employ an analysis of repeated measures     using generalized estimating equations. We will include in the regression models the     treatment group, the emotional disclosure score, the time, and the interaction between     treatment group and time.   "
173215|NCT00106743|"     This study will explore clinical and genetic aspects of Usher syndrome, an inherited disease     causing deafness or impaired hearing, visual problems, and, in some cases, unsteadiness or     balance problems. Patients with type 1 Usher syndrome usually are deaf from birth and have     speech and balance problems. Patients with type 2 disease generally are hearing impaired but     have no balance problems. Patients with type 3 disease have progressive hearing loss and     balance problems. All patients develop retinitis pigmentosa, an eye disease that causes poor     night vision and eventually, blindness.      Patients of any age with Usher syndrome may be eligible for this study. Patients who have had     eye and hearing evaluations are asked to send their medical records to the research team at     the National Eye Institute (NEI) for review. They are also asked to have a blood sample drawn     by a medical professional and sent to NEI for genetic analysis. Finally, they are interviewed     about their family histories, particularly about other relative with eye disease. Patients     who have not been evaluated previously have the following tests and procedures at NIH:        -  Family medical history, especially regarding eye disease. A family tree is drawn.        -  Blood draw for genetic studies of Usher syndrome.        -  Eye examination to assess visual acuity and eye pressure, and to examine pupils, lens,          retina, and eye movements.        -  Electroretinogram (ERG) to test the function of visual cells. Wearing eye patches, the          patient sits in a dark room for 30 minutes. Electrodes are taped to the forehead and the          eye patches are removed. The surface of the eye is numbed with eye drops and contact          lenses are placed on the eyes. The patient looks inside a hollow, dark globe and sees a          series of light flashes. Then a light is turned on inside the globe and more flashes          appear. The contact lenses sense small electrical signals generated by the retina when          the light flashes.        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina          are taken using a camera that flashes a blue light into the eye. The pictures show if          any dye has leaked from the vessels into the retina, indicating possible blood vessel          abnormality.        -  Hearing tests to help determine the patient's type of Usher syndrome. Tests to evaluate          hearing include examination of both ears with an otoscope, evaluation of the middle ear          and inner ear, and hearing tests using earphones that deliver tones and words the          subject listens and responds to.        -  Vestibular testing for balance function. Balance testing involves three procedures:      Videonystagmography: This test records eye movements with little cameras. First the patient     follows the movements of some small lights. Next, while wearing goggles, the patient lies on     an exam table and turns to the right and left. Lastly, a soft stream of air is blown into the     patient's ears four times, once in each ear with cool air and once in each ear with warm air.      Rotary chair test: With electrodes placed on the forehead, the patient sits in a rotary chair     in a dark room. Several red lights appear on the wall of the room and the patient follows the     lights as they move back and forth. Then the chair turns at several speeds, all slower than a     merry-go-round.      Vestibular evoked potential: Electrodes are placed behind the patient's ear and at the base     of the neck. Seated in a reclining chair and wearing earphones, the patient hears a brief     series of loud clicking sounds. When the sounds are on, the patient is asked to lift his or     her head up a few inches from the chair. The electrodes record information from the muscles     in the neck as the sounds enter the ear.   "
173233|NCT00109525|"     This observational study evaluated the performance of new lab tests in detecting candida     species fungal infections in extremely low birth weight (ELBW) infants quickly and     accurately. 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth     weights ≤1,000g; 100 of these infants later tested positive for candidiasis. Blood, urine,     and lumbar puncture samples were collected whenever other specimens were obtained from     participants for cultures. These samples are being tested using the new methods and compared     with standard culture results. Surviving study subjects completed a neurodevelopmental     evaluation at 18-22 months corrected age.   "
173254|NCT00109811|"     This phase II trial is studying how well vaccine therapy works in treating patients with     recurrent prostate cancer. Vaccines made from peptides may help the body build an effective     immune response to kill tumor cells   "
183698|NCT00247728|"     The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor     recurrence in patients with hepatocellular carcinoma following hepatectomy.   "
173216|NCT00106756|"     This study will examine the extent of the vision problem in familial exudative     vitreoretinopathy (FEVR) and try to identify the genes responsible for this hereditary eye     disorder. Patients with FEVR have incomplete formation of blood vessels in the periphery of     the retina (the inner part of the eye that is responsible for vision). As a result, abnormal     vessels can form and retinal detachment and vitreous bleeding can occur, causing significant     vision loss. Vision loss usually begins in childhood, gradually worsening over time. Some     patients eventually become blind.      Patients of all ages with FEVR and their family members may be eligible for this study.     Participants undergo the following tests and procedures:        -  Family history, especially regarding eye disease. A family tree is drawn.        -  Blood draw for genetic testing related to FEVR.        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to          examine pupils, lens, retina and eye movements. The pupils are dilated with drops for          this examination.        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina          are taken using a camera that flashes a blue light into the eye. The pictures show if          any dye has leaked from the vessels into the retina, indicating possible blood vessel          abnormality.        -  Patients affected with FEVR will also undergo DEXA scan to look for osteoporosis. X-rays          are used to scan the hip, forearm and spine for bone density measurements.   "
173217|NCT00106769|"     This study will test the safety of an experimental vaccine intended to prevent West Nile     virus (WNV) infection and determine if it causes side effects. WNV symptoms may vary from     fever and headache, to a polio-like syndrome with paralysis. Infection rarely results in     death. The vaccine used in this study contains DNA that instructs the body to produce a small     amount of a protein found in WNV. If the body creates resistance or immunity to these     proteins, then the vaccine may protect against WNV. Study participants cannot get WNV from     the vaccine.      Healthy volunteers between 18 years and 50 years of age may be eligible for this study.     Candidates are screened with a medical history, physical examination, and blood and urine     tests, including a pregnancy test for women who can become pregnant. Patients undergo the     following tests and procedures:        -  Vaccine injections: Vaccines are given as injections in the upper arm, using a          needleless system called the Biojector 2000. The first injection is on study day 0, the          second on day 28 (+/-) 7 days, and the third on day 56 (+/-) 7 days. There must be at          least 21 days between injections. The pregnancy test for women of childbearing potential          is repeated the day of each vaccine injection.        -  Diary card: Participants are given a 5-day diary card after each injection to record          their temperature and any symptoms and side effects they may experience for up to 5 days          after the injection. The diary cards are returned to the clinic at visits scheduled 2          weeks after each injection. Side effects and symptoms also must be reported immediately          to a study nurse or doctor, and a clinic visit may be required for an examination.        -  Clinic visits: At day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32, participants have a          medical history, physical examination (if needed) and blood tests. Vital signs and          weight are also recorded. Lymph nodes are examined at day 0 and weeks 2, 4, 6, 8, 10 and          12, and urine samples are collected at day 0 and weeks 2, 4, 6, 8 and 10.      Some of the blood drawn during this study is used for genetic tests to see if different types     of immune response to a vaccine are related to genetic differences in people.   "
173218|NCT00106782|"     This study will evaluate the effect of transcranial electrical polarization (TEP), also     called direct current (DC) stimulation, on focal hand dystonia in people with writer's cramp.     In dystonia, muscle spasms cause uncontrolled twisting and repetitive movement or abnormal     postures. Focal dystonia involves just one part of the body, such as the hand, neck or face.     When people with focal hand dystonia make small and repeated movements with their hands,     there is extra activity in the part of the brain called the motor cortex. TEP is a method of     brain stimulation that slows down the activity of the nerve cells in the motor cortex. This     study may help researchers develop new ways to treat focal hand dystonia.      People 18 years of age and older with focal hand dystonia may be eligible for this study.     Participants have a neurological examination and are randomly assigned to one of two     treatment groups: TEP or placebo stimulation. The TEP group receives stimulation to the parts     of the brain used for hand movement, and the placebo group receives sham stimulation, which     does not affect any area of the brain. There are three TEP/placebo sessions over a period of     7 to 10 days. The first session may last up to 2-1/2 hours; the other two sessions last 1-2     hours.      For TEP, sponge electrodes are placed on the scalp and an electrical current is passed     through the scalp and skull to the outer part of brain. Before and after each session,     participants have a neurological examination, including an evaluation of the rate and     severity of their movement problems. For this assessment, participants do a writing test     while the electrical activity of their hand muscles is recorded using surface     electromyography (EMG). For EMG, small metal disks (electrodes) filled with a conductive gel     are taped to the skin over the muscles being tested.      Patients are followed in the clinic the day after the end of TEP treatment for evaluation of     their movement abilities and the effects of therapy, such as improvement of handwriting.   "
173219|NCT00109330|"     This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine     compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of     age).   "
173220|NCT00109343|"     The study is being conducted to demonstrate that V221 may be administered concomitantly with     pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles,     mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.   "
173221|NCT00109356|"     The purpose of this study is to find answers to the following questions:        -  What is the largest dose of AQ4N that can be given safely one time every three weeks for          24 weeks?        -  What are the side effects of AQ4N when given according to this schedule?        -  How much AQ4N is in the blood at certain times after administration and how does the          body get rid of the drug?        -  Will AQ4N help treat lymphoid cancer?   "
173222|NCT00109369|"     The Vermont Diabetes Information System (VDIS) is a registry-based decision support and     reminder system based on the Chronic Care Model and targeted to primary care physicians and     their patients with diabetes. It will be evaluated by a randomized, controlled study in 60     Primary Care practices in Vermont and nearby New York.   "
173244|NCT00109668|"     QVAR in a standard press and breath inhaler (QVAR-MDI) has been approved by the Food and Drug     Administration (FDA) for use in the United States. The purpose of this study is to determine     the level of asthma control when comparing the safety and effectiveness of QVAR in two     different devices, a metered dose inhaler (MDI) and a breath operated inhaler (BOI).   "
173234|NCT00109538|"     The purpose of this study is to assess the benefit of lonafarnib (versus placebo) in patients     with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML). Benefit will     be measured by achievement of platelet transfusion independence for at least 8-consecutive     weeks, and without simultaneous worsening of hemoglobin and/or need for red blood cell (RBC)     transfusion. Additional endpoints will be hematologic response (which includes complete     remission, partial remission, hematologic improvement), number of RBC transfusions, bleeding     events, infections and safety.   "
173235|NCT00109551|"     The purpose of this study is to determine whether daily supplementation of young children in     Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young     children in Nepal have numerous nutritional deficiencies and high rates of morbidity and     mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these     risks.   "
174293|NCT00122434|"     The primary objective of this study is to determine the optimum dose of BEA 2180 BR     inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in     patients with COPD.   "
173223|NCT00109382|"     Current management of patients with TIA (transient ischemic attack) or minor stroke includes     the prompt investigation and treatment in the days and weeks after the event. However, new     evidence shows patients are at the highest risk of stroke in the first few days after the     TIA, with 50% of strokes which happen in the three months following TIA occurring within     48-72 hours. To date, there is no evidence to guide physicians on how to safely reduce this     risk.      The FASTER trial is focusing on the initial period of high risk, starting patients on stroke     prevention treatments in the hours following a TIA or minor stroke. The drugs to be tested     have been shown to be effective in the similar setting of cardiology, reducing recurrent     cardiac events in patients with unstable angina when commenced with the same speed after an     event.      All patients will be on aspirin. The trial will see if adding another drug, clopidogrel, has     an additional benefit in reducing the number of strokes after TIA or minor stroke within     three months of TIA or minor stroke. It will also look if the very early introduction of     simvastatin, a cholesterol lowering therapy, reduces stroke after TIA or minor stroke, both     by itself and in addition to clopidogrel. The final aim of the trial is to ensure that these     treatments are safe to be used in this population of patients.   "
173224|NCT00109395|"     This clinical trial is being performed under the Best Pharmaceuticals for Children Act,     signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The     purpose of this study is to make sure that lorazepam, when given to children who are very     sick in the Intensive Care Unit and who are on a breathing machine, is safe and works as well     as a drug called midazolam. Midazolam is already approved by the FDA for this use, but     lorazepam is not, even though both drugs are commonly used for sedation.   "
173225|NCT00109408|"     This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus     methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized     to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate     7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is     3-12 months and the target sample size is 500+ individuals.   "
173226|NCT00109421|"     The Project ÒRÉ intervention is a half-day community-based HIV/STI intervention program for     friendship groups of adolescents that is tailored to African American culture. The four     participating community sites will be assigned to either the Project ÒRÉ intervention or a     standard health promotion program. Sexually experienced African American adolescent females     will recruit members of their friendship group for the five-hour program. All participants     will complete questionnaires before and immediately following the programs and another one 3     months later. Immediately following the program some of the Project ÒRÉ groups will also     participate in a focus group to provide feedback about the program.   "
173227|NCT00109434|"     The main purpose of this study is to find out how often low blood sugar (hypoglycemia)     happens during the night after exercise in the late afternoon. The study also will see if     there are any factors that can predict if low blood sugar is going to develop. Blood samples     will also be drawn to measure two hormones—glucagon and epinephrine (adrenaline)—to see how     they are affected by exercise. Glucagon helps to raise the blood sugar when it is low.     Epinephrine causes symptoms that make the person aware that the blood sugar is low. From the     blood sample, other substances in the blood may also be measured to see how they are affected     by exercise.      A second purpose of the study is to find out whether exercise affects the accuracy of a     continuous glucose sensor (CGMS made by Medtronic Minimed).      The study will also look at the accuracy of different home glucose meters.   "
173228|NCT00109460|"     The project's aim is to provide a targeted, computer-administered intervention to facilitate     tobacco cessation for clients in alcohol treatment. The main focus of On the Air: A tobacco     cessation program for adults in alcohol recovery is to reduce tobacco use of clients in     alcohol treatment. The program will be offered through inpatient, residential, and outpatient     treatment programs to help those struggling with alcohol addiction to understand, reduce, and     stop tobacco use. Clients will develop a personalized tobacco cessation plan relevant to     their readiness to quit tobacco use. Based on the metaphor of a television network, this     tobacco cessation program contains information on personal risks, peer stories, cravings and     withdrawal, a variety of interactive activities and tools, and also motivational feedback and     tips to assist in the quitting process. Phase I was a proof of concept phase, in which we     delivered a prototype CD-ROM on tobacco cessation. Phase II will involve completing the     development of a functional CD-ROM tool which will be subjected to a clinical field trial     with a group of adults (n=196) in treatment facilities for alcohol recovery. The clinical     field study will involve finalizing the content, interface, and interactive features of the     CD-ROM. We will also gather satisfaction data from both clients and counselors in the various     treatment facilities.   "
173229|NCT00109473|"     The purpose of this study is to determine whether taking a growth hormone (GH) drug called     somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when     compared to a person with Crohn's Disease that does not receive growth hormone drug.   "
173230|NCT00109486|"     The purpose of this study is to assess any effect in children with seasonal and/or perennial     allergic rhinitis by GW685698X aqueous nasal spray (versus vehicle placebo nasal spray) on     growth using knemometry.   "
173231|NCT00109499|"     The primary purpose of this study is to assess the safety of AdGVPEDF.11D when given to     patients with wet age-related macular degeneration (AMD). AdGVPEDF.11D is a replication     deficient (E1, E3 and E4 deleted) adenovirus vector containing the gene for the PEDF (pigment     epithelium-derived factor) protein. PEDF is a protein that naturally exists in the human eye,     but whose levels are altered in diseases characterized by ocular neovascularization like AMD.     The PEDF protein is known to have anti-angiogenic effects or, in other words, it has the     ability to inhibit growth of new blood vessels.      AdGVPEDF.11D will be delivered once via intravitreal injection into one eye. The injected eye     will be the eye with the worst visual acuity.   "
173232|NCT00109512|"     This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group     study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in     a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at     the end of Week 12, follow-up continued every 4 weeks for 12 weeks.   "
180225|NCT00203099|"     This study evaluates the effect of the therapy combining GA and NAC on disease activity as     reflected by MRI parameters while assessing tolerability and safety.   "
173237|NCT00109577|"     The purpose of the trial was to determine whether a 36-ingredient micronutrient supplement     (primarily vitamins and minerals) is beneficial for the treatment of bipolar disorder, when     studied under randomized and fully blinded conditions and compared to a placebo. The     supplement is referred to as MCN36, because it contains 36 nutrients. Based on the     preliminary research on this supplement, it is hypothesized that patients who take MCN36 for     8 weeks will experience improved mood stability relative to those who take the placebo. All     participants must live EITHER in the vicinity of Calgary, Alberta, Canada, OR in the area of     San Diego, California.   "
173238|NCT00109590|"     The purpose of this study is to determine which of 3 different anti-HIV drug regimens given     to HIV infected pregnant women during and after their pregnancies is most effective in     reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and     lopinavir/ritonavir (LPV/r) will also be studied.      Study hypothesis: NVP resistance following single-dose NVP can be prevented with the     concomitant administration of additional antiretroviral therapy (ART).   "
173239|NCT00109603|"     The purpose of this study is to determine the effect of the anti-HIV drug tenofovir     disoproxil fumarate (TDF) on lipid levels in HIV infected adults on stable anti-HIV drug     therapy.      Study hypothesis: The addition of TDF to stable background antiretroviral therapy in HIV     infected individuals with dyslipidemia will result in a reduction of non-HDL after 12 weeks     of treatment.   "
173240|NCT00109616|"     Neonatal mortality and morbidity is common in Nepal and the vast majority of women deliver     babies at home without a skilled birth attendant.      The purpose of this project is two-fold: 1) to evaluate whether washing a newborn child with     a dilute antiseptic solution soon after birth can reduce mortality in the first 4 weeks of     life and 2) to evaluate whether cleaning the umbilical cord and stump with either soap and     water or an antiseptic solution for the first few days of life can reduce umbilical cord     infections.   "
173241|NCT00109629|"     This study will determine the safety and side effects of two experimental HIV vaccines given     in a prime-boost schedule. It will also monitor participants for the social impact of being     in an HIV vaccine study (e.g., problems with insurance, health care, friends, family,     employment, housing, and so forth). The vaccines are VRC-HIVDNA016-00-VP (called the DNA     vaccine) and VRC-HIVADV014-00-VP (called the rAd vaccine). The DNA vaccine codes for four HIV     proteins. The rAd vaccine is made using an adenovirus (a common virus that causes upper     respiratory infections, such as the common cold) that has been modified to contain DNA that     codes for three HIV proteins. These vaccines cannot cause HIV or adenoviral infections.      The study will also see if the vaccines cause an immune response; if the injection of the DNA     vaccine given using a needle and syringe is similar in safety and immune response to giving     them with a needleless injection device called a Biojector 2000; if people who already have     antibodies to adenovirus still have an immune response to rAd vaccine; and if there are     social harms that result from participating in an HIV vaccine study.      Healthy volunteers between 18 and 50 years of age may be eligible for this 42-week study.     Candidates are screened with a medical history, physical examination, blood and urine tests     (including pregnancy test for women), and questions regarding sexual behavior and other     practices.      Participants receive three injections (shots) of the DNA vaccine and one injection of the rAd     vaccine. All injections are given into a muscle in the upper arm (alternating right and left     arms with each injection), using a needle and syringe or the needleless Biojector 2000. The     first vaccination is given the day of enrollment into the study, and the DNA vaccinations are     given about 4 weeks apart from each other, with a minimum of 21 days between injections. The     rAd boostervaccination is given at Week 24. Participants fill out a diary card at home for     5 days after each vaccination, recording their temperature and any symptoms. They come to the     clinic for follow-up 3 days each DNA vaccine injection, and call or return again 7 days after     each injection. They call a study nurse 1 or 2 days after the rAd injection.      There are 15 to 18 clinic visits during the course of the study. At each visit, participants     are checked for health changes or problems. Blood and urine samples are collected at some     visits. Participants are periodically tested for HIV and asked questions about their sexual     behavior and drug use and are counseled throughout the study on HIV risk reduction. They are     also asked about any social effects they may have experienced as a result of their     participation in this study.   "
173242|NCT00109642|"     This study will examine the role of a brain chemical called norepinephrine in thinking,     decision-making, and emotional processing. After norepinephrine is released from a brain     cell, it binds to another brain cell's receptor. Some of the receptors it binds to are called     alpha-2 adrenergic receptors. This study will use medicines called yohimbine and guanfacine     to look at the function of norepinephrine in the brain when it binds to the alpha-2     adrenergic receptors. Yohimbine increases norepinephrine's function and guanfacine decreases     its function.      Healthy volunteers between 20 and 50 years of age who do not have heart disease, high blood     pressure, psychiatric illness, or other serious medical conditions and who are not allergic     to lactose may be eligible for this study. Candidates are screened with a medical and     psychiatric history, physical examination, neuropsychological testing, blood and urine tests     and electrocardiogram. Women are screened with a urine pregnancy test.      Participants are given a pill of yohimbine, guanfacine, or placebo and undergo the following     tests and procedures:        -  Blood pressure and heart rate measurements: Blood pressure and heart rate are measured          before the medication is taken and several times after.        -  Blood draws: Blood is drawn before the medicine is taken and 90 minutes after to measure          levels of norepinephrine and the hormone cortisol.        -  Neurocognitive testing: Participants do neurocognitive tasks on the computer for up to          90 minutes. The tasks involve looking at pictures or words on a screen and responding          according to instructions given.        -  Magnetic resonance imaging (MRI): Patients may undergo neurocognitive testing MRIs. This          test uses a strong magnetic field and radio waves to show changes in brain activity. The          subject lies on a table that slides into a narrow cylinder (the MRI scanner). Images of          the brain are obtained while the subject performs the computer tasks.   "
173243|NCT00109655|"     The main purpose of this research study is to evaluate the safety and dosing of CG0070.   "
173246|NCT00109707|"     The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity,     and pharmacokinetics of AMN107 in six groups of patients with one of the following     conditions:      Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1)      Group A - Imatinib failure only (arms 2, 3 and 4)        -  imatinib-resistant or intolerant CML - Chronic Phase (CP)        -  imatinib-resistant or intolerant CML - Accelerated Phase (AP)        -  imatinib-resistant or intolerant CML - Blast Crisis (BC)      Group B - Imatinib and other TKI failure (arms 2, 3 and 4)        -  imatinib-resistant or intolerant CML - Chronic Phase (CP)        -  imatinib-resistant or intolerant CML - Accelerated Phase (AP)        -  imatinib-resistant or intolerant CML - Blast Crisis (BC)      Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5)      Systemic mastocytosis (Sm) (arm 6)   "
173247|NCT00109720|"     The purpose of this study is to find out if Self-Management Consultant (SMC) intervention     will be more effective than usual care in improving blood glucose control and     diabetes-related quality of life for adults with type 2 diabetes.   "
173248|NCT00109733|"     The primary objective is to evaluate the efficacy and safety of two different dose regimens     of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during     the transition phase from childhood to adulthood.   "
173249|NCT00109746|"     The purpose of this study is to determine the effectiveness of the nutritional supplement     chromium picolinate in improving insulin resistance, a symptom of diabetes, in HIV-infected     patients. The ultimate goal is to find a simple therapy that can prevent the development of     diabetes in individuals with HIV.   "
173250|NCT00109759|"     The safety and tolerability of tyrosine adsorbed ragweed pollen allergoid with monophosphoryl     lipid A (MPL) will be evaluated. For this purpose, a total of 4 injections of either     increasing doses of the study drug or placebo (tyrosine) will be administered in 7-day     intervals to healthy volunteers.   "
173255|NCT00109824|"     Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Valproic acid     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Giving decitabine together with valproic acid may be an effective treatment for non-Hodgkin's     lymphoma. This phase I trial is studying the side effects and best dose of decitabine and     valproic acid in treating patients with relapsed or refractory aggressive B-cell     non-Hodgkin's lymphoma.   "
173256|NCT00109837|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy), and giving the drugs in different combinations may kill more     cancer cells.      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating     patients with newly diagnosed acute lymphoblastic leukemia.   "
173257|NCT00109850|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth     of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     cetuximab together with combination chemotherapy and radiation therapy may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination     chemotherapy and radiation therapy works in treating patients with locally advanced     esophageal cancer that cannot be removed by surgery.   "
173258|NCT00109863|"     RATIONALE: Biological therapies, such as hu14.18-interleukin-2 fusion protein, may stimulate     the immune system in different ways and stop tumor cells from growing.      PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works     in treating patients with advanced melanoma.   "
173259|NCT00109876|"     This pilot clinical trial studies how well radiofrequency ablation works in treating patients     with stage IA non-small cell lung cancer. Radiofrequency ablation uses high-frequency     electric current to kill tumor cells. Computed tomography (CT)-guided radiofrequency ablation     may be a better treatment for non-small cell lung cancer.   "
173260|NCT00109889|"     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and     fludeoxyglucose F 18 positron emission tomography (^18FDG-PET) may help diagnose solitary     plasmacytoma.      PURPOSE: This clinical trial is studying MRI and ^18FDG-PET to see how well they work in     diagnosing patients with solitary plasmacytoma.   "
173261|NCT00109928|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, gemcitabine, and     methylprednisolone, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving more than one drug (combination     chemotherapy) may kill more cancer cells.      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating     patients with newly diagnosed stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.   "
173262|NCT00109941|"     RATIONALE: Opioid growth factor may stop the growth of pancreatic cancer by blocking blood     flow to the tumor.      PURPOSE: This phase II trial is studying how well opioid growth factor works in treating     patients with advanced pancreatic cancer that cannot be removed by surgery.   "
173263|NCT00109954|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. In this     case, chemotherapy is given through the artery (hepatic artery) that brings blood to the     tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and     keeping chemotherapy drugs near the tumor. Internal radiation uses radioactive material     placed directly into or near a tumor to kill tumor cells. It is not yet known whether hepatic     arterial chemoembolization with cisplatin is more effective than internal radiation therapy     in treating liver cancer.      PURPOSE: This randomized phase III trial is studying hepatic arterial chemoembolization with     cisplatin to see how well it works compared to internal radiation therapy in treating     patients with advanced liver cancer that cannot be removed by surgery.   "
173264|NCT00109967|"     This phase II trial is studying how well giving CCI-779 together with rituximab works in     treating patients with relapsed or refractory mantle cell lymphoma. Drugs used in     chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. Giving CCI-779 together with rituximab may kill more cancer cells   "
173265|NCT00109980|"     The purpose of this study is to investigate and compare the use of herbal medicine among     Dominicans in New York City and the Dominican Republic.   "
173266|NCT00109993|"     RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for     graft-versus-host disease caused by a donor stem cell transplant.      PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus     and methylprednisolone works in treating acute graft-versus-host disease in patients who have     undergone donor stem cell transplant.   "
173267|NCT00110006|"     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using     fludeoxyglucose F 18, may help in learning how well chemotherapy works to kill cancer cells     and allow doctors to plan better treatment. Comparing results of diagnostic procedures done     before, during, and after chemotherapy may help doctors predict a patient's response to     treatment and help plan the best treatment.      PURPOSE: This clinical trial is studying positron emission tomography using fludeoxyglucose F     18 to see how well it works in predicting response to treatment in patients who are receiving     rituximab and combination chemotherapy for newly diagnosed non-Hodgkin's lymphoma.   "
173281|NCT00110201|"     The purpose of this trial is to study the use of nesiritide in thoracic aneurysm repair to     prevent acute renal failure.      The study hypothesis: Nesiritide, given prophylactically prior to surgery may prevent acute     renal failure requiring dialysis and/or decrease mortality.   "
173268|NCT00110019|"     This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to     see how well they work compared to carboplatin and paclitaxel in treating patients with stage     III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such     as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth and by     blocking blood flow to the tumor. It is not yet known whether giving carboplatin and     paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel     in treating melanoma.   "
173269|NCT00110032|"     This phase I trial is studying the side effects of fluorine F18 EF5 when given during     positron emission tomography to find oxygen in tumor cells of patients who are undergoing     surgery or biopsy for newly diagnosed brain tumors. Diagnostic procedures using fluorine F 18     EF5 and positron emission tomography to detect tumor hypoxia may help in planning cancer     treatment   "
173270|NCT00110045|"     RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal     infections caused by chemotherapy or stem cell transplant.      PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line     treatment for aspergillosis in patients with hematologic cancer or in patients who have     undergone a stem cell transplant.   "
173271|NCT00110058|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.     It also stops the patient's immune system from rejecting the donor's stem cells. The donated     stem cells may replace the patient's immune system and help destroy any remaining cancer     cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor     lymphocyte infusion) or interferon alfa after the transplant may help increase this effect.     Sometimes the transplanted cells from a donor can also make an immune response against the     body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may     stop this from happening.      PURPOSE: This phase II trial is studying how well giving fludarabine together with radiation     therapy works in treating patients who are undergoing donor stem cell transplant for chronic     phase or accelerated phase chronic myelogenous leukemia.   "
173272|NCT00110071|"     This phase I trial studies the side effects and best dose of fludarabine (fludarabine     phosphate) when given together with iodine I 131 tositumomab in treating older patients who     are undergoing an autologous or syngeneic stem cell transplant for relapsed or refractory     B-cell non-Hodgkin's lymphoma (NHL). Radiolabeled monoclonal antibodies, such as iodine I 131     tositumomab, can find cancer cells and carry cancer-killing substances to them without     harming normal cells. Drugs used in chemotherapy, such as fludarabine, work in different ways     to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that     were destroyed by chemotherapy and radiation therapy. Giving iodine I 131 tositumomab     together with fludarabine followed by autologous stem cell transplant may be an effective     treatment for NHL   "
173273|NCT00110084|"     RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin     Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine     works in treating women with metastatic breast cancer.   "
173274|NCT00110110|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, and vincristine, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the     growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cyclosporine     together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed.     Cryotherapy kills tumor cells by freezing them. Laser therapy uses light to kill tumor cells.     Giving combination chemotherapy together with cyclosporine followed by cryotherapy and/or     laser therapy may be an effective treatment for retinoblastoma.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with cyclosporine followed by cryotherapy and/or laser therapy works in treating patients     with newly diagnosed retinoblastoma in both eyes.   "
173275|NCT00110123|"     RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving the drugs in different ways may kill more tumor cells. It is not yet known whether     giving fotemustine as an intravenous infusion is more effective than giving it as a hepatic     arterial infusion in treating liver metastases.      PURPOSE: This randomized phase III trial is studying intravenous infusion of fotemustine to     see how well it works compared to hepatic arterial infusion of fotemustine in treating     patients with unresectable liver metastases from eye melanoma.   "
173276|NCT00110136|"     RATIONALE: St. John's wort may help relieve hot flashes in women with breast cancer.      PURPOSE: This phase II trial is studying how well St. John's wort works in relieving hot     flashes in women with non-metastatic breast cancer.   "
173277|NCT00110149|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others, such as yttrium Y 90     ibritumomab tiuxetan, find cancer cells and help kill them or carry cancer-killing substances     to them without harming normal cells. Giving rituximab together with yttrium Y 90 ibritumomab     tiuxetan may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with yttrium Y 90     ibritumomab tiuxetan works in treating patients with indolent non-Hodgkin's lymphoma.   "
173278|NCT00110162|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation     therapy may stop the adrenal glands from making androgens.      PURPOSE: This randomized phase III trial is studying how well androgen deprivation therapy     works in treating patients with prostate cancer.   "
173279|NCT00110175|"     This study will determine in stroke patients whether stimulation of the injured side of the     brain combined with stimulation of the weak hand can temporarily improve motor function of     the paralyzed hand. It will also examine whether stimulation of the healthy side of the brain     combined with stimulation of the weak hand can temporarily improve motor function in the     paralyzed hand.      Healthy adult volunteers and adults who have had a stroke more than 3 months before entering     the study may be eligible to participate. Candidates are screened with a physical and     neurological examination. Stroke patients also have magnetic resonance imaging (MRI), a test     that uses a strong magnetic field and radio waves to obtain images of the brain.      Participants perform several tasks (described below) in a practice session and then during     five more sessions on separate days. They perform the tasks before and after undergoing     transcranial direct current stimulation (tDCS) plus electrical stimulation (ES), and during a     procedure that involves sham stimulation. For tDCS, small rubber electrodes are soaked with     water and taped to the subject's head, one above the eye and the other on the back of the     head. The current passes between the two electrodes. For ES, two pairs of electrodes are     attached to the subject's wrist with a paste. A very short pulse of current is passed between     the electrodes, creating an electrical field that stimulates the brain. For the sham     stimulation, the electrodes are similarly placed, but there is no stimulation. The tasks are:        -  Jebsen-Taylor test: Subjects write, lift small common objects like paper clips, and          perform activities like turning pages, stacking checkers or lifting large objects. They          do these tasks as fast as possible.        -  Pinch force: Subjects press a wedged instrument between their thumb and index finger as          hard as they can. There are several trials every 10 seconds.        -  Speed tapping: Subjects press a key on a keyboard as quickly as possible for 10 seconds.        -  Simple reaction time task: Subjects perform a quick wrist movement as quickly as          possible in response to a go signal presented on a computer monitor. Muscle activity          in the forearm is recorded using electrodes.        -  Motor sequence learning/Learning a finger movement sequence: Subjects practice a finger          movement exercise on a keyboard by pressing keys that correspond to a number displayed          on a video screen.        -  Visual analog scales: Subjects complete three questionnaires about their attention,          fatigue, and mood.        -  Sensory monitoring: Subjects are blindfolded and asked to judge the difference in          various sensations, such as the feel of plastic domes with gratings, vibration, or a          plastic hair applied to their fingertip.        -  Scoring MRC scale: The muscle strength of the subject's hands is measured.        -  Fugl-Meyer scale: The subject's ability to move his or her limbs is measured.        -  Mini-mental state examination: The subject's mental ability is measured briefly.        -  Handedness questionnaire: The subject's dominant hand is determined.      Participants also undergo transcranial magnetic stimulation (TMS) and electromyography (EMG)     before, during and after these activities. For TMS, a wire coil is held on the scalp. A brief     electrical current is passed through the coil, creating a magnetic pulse that stimulates the     brain. The effect of TMS on the muscles is detected with small electrodes taped to the skin     of the arms or legs. EMG measures the electrical activity of the muscles. For this test,     small electrodes are taped to the skin over the muscle.   "
173280|NCT00110188|"     The purpose of this study is to assess the antitumor activity of weekly ridaforolimus study     treatment in participants with taxane-resistant AIPC.   "
174324|NCT00122837|"     This is a clinical trial assessing duloxetine and comparator to placebo in patients who have     generalized anxiety disorder.   "
173282|NCT00110214|"     This randomized phase III trial is studying docetaxel, prednisone, and bevacizumab to see how     well they work compared to docetaxel and prednisone in treating patients with prostate cancer     that did not respond to hormone therapy. Drugs used in chemotherapy, such as docetaxel and     prednisone, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It     is not yet known whether docetaxel, prednisone, and bevacizumab are more effective than     docetaxel and prednisone in treating prostate cancer.   "
173283|NCT00110227|"     The purpose of this study is to determine the effects of a tai chi exercise program on     functional capacity and health-related quality of life in patients with chronic heart failure     (HF). This study will also examine the way tai chi influences mental, physical, and social     functioning.   "
173284|NCT00110240|"     This study is not being conducted in the United States. The purpose of this study is to     assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose     in lowering overall blood glucose levels in people with type 2 diabetes who have not been     previously treated with drug therapy to lower their blood sugar.   "
173285|NCT00110253|"     S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a new skin numbing cream made of     lidocaine and tetracaine. The purpose of this study is to evaluate and measure the length of     time the S-Caine Peel numbs the skin, when applied for 30 and 60 minutes.   "
173286|NCT00110266|"     The purpose of this trial is to examine the safety and efficacy of deferasirox in patients     with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.   "
173287|NCT00110279|"     Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and     other parts of the world. The purpose of this study is to test the safety of and immune     response to a new AI vaccine in healthy adults.      Study hypothesis: Influenza A viruses are widely distributed in nature and infect a wide     variety of birds and mammals. The direct transmission of avian influenza viruses from birds     to humans has recently become a major health concern in Asia and other parts of the world,     raising concern of a possible influenza pandemic in humans. This vaccine will evaluate the     safety, infectivity and immunogenicity of Live Influenza A vaccine H9N2 (6-2) AA ca     reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a cold-adapted, live     attenuated virus vaccine administered intranasally for the protection of humans against     pandemic influenza viruses of the H9N2 subtype.   "
173288|NCT00110292|"     This study will evaluate a program to prevent learning problems in children. The program is     an inexpensive public health outreach program designed for families living in poverty and is     administered through pediatricians' offices and clinics.   "
173289|NCT00110305|"     The purpose of this study is to evaluate the dose-response relationship of antiviral activity     after 48 weeks treatment with 3 different dose regimens of TMC278.   "
173290|NCT00110318|"     This randomised controlled trial will evaluate the role of manual therapy and therapeutic     exercise and corticosteroid injections in the treatment of lateral epicondylalgia (tennis     elbow).   "
173291|NCT00110331|"     This study will examine how HIV affects the brain and nervous system, learning, and behavior     in children on highly active antiretroviral therapy (HAART). Although HAART has resulted in     fewer HIV-infected children getting sick and even fewer dying from AIDS, many children on     this treatment regimen develop significant brain or nervous system problems, such as learning     difficulties, attention problems, hyperactivity, and depression.      People who acquired HIV disease in the first decade of life and who have evidence of central     nervous system (CNS) disease (e.g., encephalopathy, CNS compromise, ADHD, bipolar disease,     major depression or psychosis) may be eligible for this study. Candidates are screened with a     medical history, physical examination, neuropsychological testing and a CT scan of the head,     if one has not been done within 12 months of entering the study.      Participants undergo the following tests and procedures:        -  MRI and MRS scan of the head: These tests use a magnetic field and radio waves to obtain          images of the brain and detect changes in certain brain chemicals that may be affected          by HIV infection. Both procedures are done at the same time. The patient lies on a table          that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud          knocking and thumping sounds that occur during the scanning process. The procedure lasts          about 50 to 60 minutes, during which time the patient can communicate with the staff.        -  Neuropsychological testing: Patients' thinking and behavior are evaluated with tests to          measure their memory, attention, language, problem-solving, academic, and motor skills          and questionnaires to assess behavioral and emotional functioning, quality of life, and          adherence to HIV medication. Parents are also asked to complete questionnaires assessing          their child's behavioral and emotional functioning, quality of life, important life          events, and adherence to HIV medication.        -  Lumbar puncture (spinal tap): Cerebrospinal fluid (CSF) is collected for analysis. For          this procedure, a local anesthetic is given and a needle is inserted in the space          between the bones in the lower back where the CSF circulates below the spinal cord. Some          fluid is collected through the needle. Blood tests and a physical examination are done          before the procedure to make sure it can be done as safely as possible. Patients may          also be sedated to prevent any discomfort.        -  Follow-up: The blood tests, MRI and MRS scans and spinal tap are repeated 1 and 2 years          after the initial evaluation.      Some blood and spinal fluid samples from participants are stored for possible future studies     related to HIV research   "
173292|NCT00110344|"     This study has been designed to study patients diagnosed with advanced renal cell cancer with     the primary tumor in place.   "
173293|NCT00110357|"     The purpose of this clinical research study is to establish the maximum tolerated dose and     recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and     adolescent patients with refractory solid tumors.   "
173294|NCT00110370|"     The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given     three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with     the addition of insulin lispro given three times daily with meals). The study is also     comparing two different methods for adjusting the dose of insulin.   "
173295|NCT00110383|"     1. Develop a simple school-based intervention using school-based supervised asthma therapy          to increase adherence to asthma medication.        2. Implement a school-based internet monitoring system within both the school-based          supervised asthma therapy and parent supervised asthma therapy groups to record asthma          symptoms, peak flow meter readings, school absences, and usage of rescue medications at          school.        3. Randomly assign 250 children from inner-city school systems to either school-based          supervised asthma therapy or parental supervised asthma therapy.        4. Compare children assigned to school-based supervised asthma therapy with children          assigned to parent supervised asthma therapy, in regards to time-averaged proportion          having at least one exacerbation per month, rescue medication use, peak flow meter          readings, asthma symptoms, school absences, and asthma self-management knowledge.   "
173297|NCT00110409|"     The objective of this randomized trial is to assess the effectiveness of an intervention     involving education, self-efficacy, and social support in improving quality of life outcomes     among 296 adult asthma patients treated in the emergency room. The main outcome will be a     comparison of within-patient change in quality of life between enrollment and 8 weeks.     Secondary objectives will be to assess the effectiveness of the intervention in decreasing     the need for rescue inhaled beta agonists, in improving peak flow meter rates, and in     decreasing the number of days lost from work or school due to asthma. These outcomes will be     measured again at 16 weeks to determine if benefits are sustained. Additional outcomes at 16     weeks and 1 year will be to assess the effectiveness of the intervention in decreasing urgent     resource utilization for asthma and cost effectiveness.   "
173298|NCT00110422|"     The purpose of this clinical research study is to learn if irbesartan is superior to     hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in     hypertensive patients with metabolic syndrome.   "
173299|NCT00110435|"     The purpose of this 10-week study is to compare the reduction in cholesterol following     treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and     hypercholesterolemia.   "
173300|NCT00110448|"     The purpose of this study is to determine the effects of low-dose aspirin for the primary     prevention of vascular events in patients with type 2 diabetes in Japan.   "
173301|NCT00110461|"     The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in     child and adolescent patients with bipolar I disorder, manic or mixed episode with or without     psychotic features.   "
173302|NCT00110474|"     The primary objective of this study is to evaluate the efficacy and safety of glucosamine     sulfate versus placebo on the symptoms of knee osteoarthritis after 6 months of treatment,     using acetaminophen as a reference symptomatic medication.   "
173303|NCT00110487|"     The purpose of this investigational study is to determine if a study medication is safe and     effective in reducing the symptoms associated with endometriosis; if the study medication     reduces the need for pain medication for endometriosis symptoms; and if the study medication     improves a participant's ability to carry out daily activities. Qualified participants will     receive no cost treatment, which may include study-related examinations, diagnostic     procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified     participants will also receive study medication at no cost. As a participant, the study     volunteer may also experience the satisfaction of knowing she is helping the advancement of     women's health care.   "
173304|NCT00110500|"     The purpose of this study is to evaluate the clinical and laboratory safety of SB-509 when     given as a single treatment by an intramuscular injection to subjects with diabetic     neuropathy.   "
173318|NCT00110682|"     Study Aims:        -  To compare the long-term efficacy and safety of imiquimod versus vehicle used as an          adjunct to cryotherapy.        -  To assess and compare the recurrence rate and time to recurrence of the 2 different          treatment groups.      Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses     (AK) compared to the vehicle arm.   "
173305|NCT00110513|"     Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis     and pulmonary embolism, particularly during certain high risk procedures. The trial focused     on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical     procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study     assessed the incidence of thromboembolic events following prophylactic intravenous     administration of recombinant human antithrombin (rhAT) to patients with hereditary     antithrombin (AT) deficiency in situations usually associated with a high risk for     thromboembolic events.   "
173306|NCT00110526|"     The purpose of this research study is to test a new treatment for prostate cancer. We have     been exploring the use of cytokine (immune stimulating) gene therapy by directly injecting a     virus which produces a cytokine called interleukin-12 (IL-12) into the prostate gland to     control tumor growth. We propose to explore the use of adenovirus-mediated human     interleukin-12 (Ad.hIL-12) in patients with recurrent non-metastatic prostate cancer     following radiation therapy in a Phase I trial. Participants will be placed in rising dose     groups with the primary endpoint of learning the maximum dose that can safely be given by     injection directly into the prostate gland. Toxicity will be determined through physical     examination, laboratory values, and blood levels of cytokines. Evidence of an immune response     against prostate proteins will also be monitored. If the treatment works, the cancer will     shrink or not grow. This will be monitored by prostate specific antigen (PSA) levels in the     blood. However, we do not know if this treatment will be effective. If the PSA continues to     rise after treatment, participants will be taken off study and offered other treatment. There     is no compensation for participation in this research study. There will be no charge for the     treatment with gene therapy or the monitoring associated with this research study. Monitoring     will occur in a specially designated clinical research center.   "
173307|NCT00110539|"     The purpose of this study is to determine the effectiveness of four different strategies     designed to improve clinicians' knowledge about herbs and dietary supplements. This study     will also increase their confidence in their ability to answer patient questions about these     topics.      Study hypotheses: 1) Delivery of modules over 10 weeks will lead to better educational     outcomes than delivery of modules at one time. 2) The method of module delivery that directly     lists the modules in an email will be associated with greater improvements in knowledge,     confidence, and communication skills and greater satisfaction with the overall curriculum     than methods that involve the delivery of only links to the modules in an email. 3) Active     participation in a moderated mailing list will enhance outcomes and satisfaction with the     curriculum more than non-participation or passive participation (reading the messages of     others). 4) More positive attitudes toward the use of and greater use of computer and     Internet technologies at baseline will be associated with more active participation in the     mailing list; greater use of the modules delivered through links; greater improvements in     knowledge, confidence, and communication; and more positive attitudes about the curriculum     following participation in the study.   "
173308|NCT00110552|"     The purpose of this study is to determine the effectiveness of the herb sage in improving the     mental function of individuals with Alzheimer's disease.      Study hypothesis: The administration of sage will improve cognitive function in patients with     mild Alzheimer's disease.   "
173310|NCT00110578|"     Effective, suppressive treatment for HIV infected patients can be a major challenge because     HIV progressively destroys their immune systems. CD8 cells isolated from a patient's blood     and grown in large numbers in the laboratory may increase a patient's immune system response     to HIV. The purpose of this study is to determine if CD8 cells will provide effective     antiviral activity against HIV when transplanted back in large numbers into HIV infected     patients.      Study hypothesis: There are specific cells in the immune system that recognize and can kill     HIV-infected cells.   "
173311|NCT00110591|"     The purpose of the study is to determine the safety and tolerability of PRO 140, an     investigational anti-HIV drug, administered via intravenous infusion.      Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans     and will result in measurable concentrations of the product in serum.   "
173312|NCT00110604|"     The purpose of this study is to determine if folic acid supplementation can slow down     atherosclerotic progression, age-related cognitive decline and age-related hearing loss.   "
173313|NCT00110617|"     This study will examine the long-term safety and efficacy of Deferasirox in patients with     sickle cell disease and iron overload from repeated blood transfusions.   "
173314|NCT00110630|"     The purpose of this study is to determine the efficacy of a 10-week smoking cessation therapy     combined with NicoDerm CQ for smoking cessation among female prisoners.   "
173315|NCT00110643|"     The purpose of this research project is to study the effect of non-ablative (non-cutting)     laser therapy, a technique that uses laser energy to try to improve the appearance of the     skin. In this study, we are interested in learning how well such a laser works to improve the     symptoms of acne. The laser used in this particular study will be the CoolTouch II® laser,     manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.   "
173316|NCT00110656|"     The purpose of this study is to collect local laboratory data on immunoreactive parathyroid     hormone (iPTH), calcium and phosphorus levels and estimated glomerular filtration rate (GFR)     at approximately 1 week, 1 month, 3 months, 6 months and 12 months after the kidney     transplant.   "
173317|NCT00110669|"     This study will help to determine whether a high-dose weekly course of prednisone therapy is     safer than and at least as effective as daily dose therapy for people with Duchenne muscular     dystrophy (DMD). Boys who are enrolled in this study should not have taken carnitine, other     amino acids, creatine, glutamine, Coenzyme Q10 or any herbal medicines within the last three     months. There will be a two-visit screening to take place in one week to ensure a     reproducible manual muscle test. The subject will then be randomized and put into either the     daily or weekly regimen. The duration of the study is twelve 28-day treatment cycles     (approximately 12 months) with follow-up visits at month one, three and then every three     months.   "
173321|NCT00110721|"     This is a Phase II, multi-center study of GM-CT-01 which has been shown to increase the     anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug commonly     used in cancer patients. In this Phase II study, patients with colon cancer which has spread,     despite treatment with approved therapies, will receive GM-CT-01 plus 5-FU in monthly cycles     for at least 2 cycles or until their disease progresses.   "
173322|NCT00110734|"     There is pain associated with laser-assisted tattoo removal. For this reason, some form of     anesthesia is commonly used to eliminate or minimize the pain. This anesthesia is usually a     topical local anesthetic cream or ointment spread over the skin. The purpose of this study is     to further estimate the effectiveness of S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream)     for treating pain during laser-assisted tattoo removal.   "
173323|NCT00110747|"     Lasers are used for non-ablative resurfacing of facial rhytides, atrophic scars, and a     variety of epidermal and dermal lesions. Pain associated with the non-ablative laser     treatment has been described as moderate to severe. For this reason, local anesthesia is     commonly used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine     7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is     to evaluate if S-Caine Peel is effective in providing topical local dermal anesthesia for     non-ablative facial laser resurfacing in adults.   "
173324|NCT00110760|"     Injection of dermal filler is used as an aesthetic treatment to fill in unwanted wrinkles and     scars. There can be substantial pain associated with dermal filler injections. For this     reason, local anesthesia is often used to eliminate or minimize the pain. This anesthesia can     be administered by injection or through the use of topical creams and ointments.      S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine     and tetracaine. The purpose of this study is to evaluate if S-Caine Peel is effective in     providing topical local dermal anesthesia for dermal filler injections in adults.   "
173325|NCT00110773|"     Pulsed dye laser (PDL) on the face is painful. For this reason, local anesthesia is commonly     used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream)     is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to     evaluate the efficacy of S-Caine Peel for induction of local dermal anesthesia for PDL     therapy in adults.   "
173326|NCT00110786|"     Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for     patients with hypersensitivity to ragweed pollen (hay fever). This novel formulation is     designed to provide a vaccine that will be efficacious with only four escalating dose     injections administered before the start of the pollen season.      In this study, the safety and efficacy of Ragweed MATAMPL will be assessed by exposing     allergic subjects to Ragweed pollen in an environmental exposure chamber (EEC). Patient     symptomatic response to pollen and patient quality of life in the EEC will be determined.   "
173327|NCT00110799|"     SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet     counts in healthy volunteers. This study is examining several different doses of SB497115 as     a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential     candidates for antiviral treatment with pegylated interferon and ribavirin. The study will be     conducted in two phases, Parts 1 and 2. In Part 1, study subjects will be randomized to 4     weeks of SB-497115-GR or placebo administered daily without antiviral therapy. Subjects who     successfully complete Part 1 (platelet count 70,000/µL for Pegasys and platelet count     100,000/µL for PEG-Intron) will then proceed to Part 2. In Part 2, subjects will receive an     additional 8 weeks of SB-497115-GR or placebo administered daily with antiviral therapy.   "
173328|NCT00110812|"     The purpose of this study is to determine the effect of short cycles of recombinant     interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in     HIV infected patients. The effects will be compared with a study group that receives no IL-2     or antiretroviral therapy.      Study hypothesis: Intermittent aldesleukin, when given without antiretroviral therapy to     patients with early HIV infection, will produce no change in HIV viral load and increases in     CD4+ T lymphocyte counts comparable to aldesleukin administered with antiretrovirals.   "
173329|NCT00110825|"     Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment     strategy in promoting longer-term smoking abstinence. We will also conduct secondary analyses     of mediators and moderators of treatment response.   "
173330|NCT00110838|"     The objective of the SOFA trial is to investigate whether supplemental intake of n-3     polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of     life-threatening ventricular arrhythmias in patients with an implantable cardioverter     defibrillator (ICD).   "
173331|NCT00110851|"     This study is designed to evaluate the safety and efficacy of PN2034 administered to type 2     diabetics on concomitant rosiglitazone and metformin (or Avandamet) therapy as measured by     change in glycosylated hemoglobin (HbA1c) levels from baseline to Week 12. Also the study     will evaluate the effect of PN2034 on glucose control as measured by fasting plasma glucose     (FPG) and on fasting lipid levels: triglycerides, total cholesterol, high-density     lipoproteins (HDL), low-density lipoproteins (LDL), and very low-density lipoproteins (VLDL).   "
173332|NCT00110864|"     This study is designed to evaluate the safety and efficacy of PN2034 in insulin-dependent     type 2 diabetics as measured by the change in average daily insulin dose from baseline to     week 12. The effects of PN2034 on HbA1c, fasting plasma glucose (FPG), and lipid levels will     also be measured.   "
173333|NCT00110877|"     Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy,     safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra     (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.   "
173334|NCT00110890|"     The purpose of this study is to evaluate the ability of a treatment strategy, that includes     cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid     hormone (PTH) compared with the standard of care.   "
173335|NCT00110903|"     The purpose of this study is to assess the safety of etanercept liquid administered once     weekly to subjects with RA.   "
173336|NCT00110916|"     The purpose of this study is to evaluate the clinical response in subjects with symptomatic     OA of the knee following a single 50 mg anakinra, 150 mg anakinra or placebo intra-articular     (IA) injection.   "
173340|NCT00110968|"     Itopride is a compound already marketed in Japan and in some countries of Eastern Europe     under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients     suffering from this condition have difficulties digesting food. Patients feel full after     eating, they have bloating and have stomach pain. The goal of this study is to see if     Itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.   "
173341|NCT00110981|"     The purpose of this study is to evaluate the safety and effectiveness of combination therapy     with etanercept and narrow-band (NB) UVB phototherapy for the treatment of psoriasis in a     pilot study. This is a Phase 4 clinical study being conducted under an Amgen Investigational     New Drug Application (IND).   "
173342|NCT00110994|"     This is a randomized, double blind, placebo controlled, multicenter, phase II study to     compare the anti-tumor activity as measured by progression-free survival (PFS) and the     tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination     with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not     received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be     randomized to receive DTIC + Sorafenib or DTIC + Placebo.   "
173343|NCT00111007|"     The objectives of this study are to compare the anti-tumor activity as measured by     Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel     and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects     with unresectable Stage III or Stage IV melanoma who progressed after receiving only one     prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).   "
173344|NCT00111020|"     This treatment protocol allows doctors to treat advanced kidney cancer with an     investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials     for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial     in which sorafenib is compared to another equal treatment. All patients in this protocol will     be treated with sorafenib. In addition, data from the patients who participate in this     protocol will provide additional information about the drug.   "
173345|NCT00111046|"     The purpose of this study is to assess post operative pain following the insertion of     radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or     tramadol.   "
173346|NCT00111059|"     Cardiovascular risk factors and psycho-social characteristics will be determined in obese and     non-obese patients in the setting of primary medical care.   "
173361|NCT00111254|"     This research project aims to study the effects of microdermabrasion, a technique causing     minimal injury used to improve the appearance of fine lines, wrinkles, and scars. Subjects     will undergo microdermabrasion, which is a gentle sand-blasting of the skin. We are     interested in determining how this procedure works at rebuilding the skin following     microdermabrasion.   "
173362|NCT00111267|"     The purpose of this trial is to study the effects of oral vitamin B12 supplementation and     vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in     elderly people with mild vitamin B12 deficiency.   "
173363|NCT00111280|"     This is a Phase II, open-label, roll-over trial to evaluate the long term safety and     tolerability of TMC125, administered as part of an individually optimized antiretroviral     therapy, in HIV 1 infected subjects. In addition, the antiviral activity and immunological     effect of TMC125 as part of an antiretroviral regimen over time, and the evolution of HIV     phenotype and genotype will be evaluated.   "
173558|NCT00115609|"     Successful therapy of both tuberculosis and HIV disease share similar problems: pill burden,     drug interaction, adherence challenge and toxicity. This study will test the efficacy and     safety of a once daily antiretroviral regimen in HIV-tuberculosis coinfected patients.   "
173347|NCT00111072|"     This study will evaluate the effectiveness of dexamethasone 0.01% solution in treating pain     associated with oral lichen planus, a chronic disease that causes painful ulcers inside the     mouth. The cause of lichen planus not known, but it may be related to an allergic or immune     reaction. This study will examine what causes the disease, the pain associated with it, its     impact on patients' lives and the use of dexamethasone to treat it.      Patients 12 or older with severe oral lichen planus may be eligible for this study.     Candidates are screened with blood tests and a biopsy to confirm the diagnosis and provide     tissues for research purposes. For the biopsy, two small circles of tissue, each about 4 mm     (1/5 inch) across, are surgically removed.      Participants are randomly assigned to rinse their mouth with either a dexamethasone solution     or placebo (a rinse with no active ingredient) four times a day for 4 weeks. During this     period they may not use any oral or topical pain or anti-inflammatory medications except     diphenhydramine 12.5 mg/5 ml (a topical numbing medicine) and Tylenol, both which are     provided by the study.      Patients come to the NIH Clinical Center for three 1-hour visits (once every two weeks) and     once more 4 weeks after the study medications are stopped. At the first three visits patients     submit a pain diary in which they have recorded information on pain levels, and they are     checked for any medication side effects. On the third visit (the last day they take the study     drug) they are also tested for adrenal suppression that may have resulted from taking the     steroid rinse. For this test they are given an injection of a drug called synacthen and after     1 hour, a blood sample is drawn. Patients return for a final visit 1 month later to determine     if their disease returns or improves after the medication is stopped.   "
173348|NCT00111085|"     The purpose of the study is to measure how effective and safe three different doses of the     drug clazosentan are in preventing vasospasm after subarachnoid hemorrhage.   "
173349|NCT00111098|"     The proposed study is designed to test a novel dosing paradigm that would facilitate the     treatment of anemia in CKD patients not on dialysis. Anemic patients who have achieved and     maintained target hemoglobin (Hb) on every 2 weeks (Q2W) dosing of darbepoetin alfa will have     the dosing interval extended to once monthly (QM) dosing. Extending the dosing interval for     darbepoetin alfa to QM represents a major potential benefit to both patients with CKD and     their caregivers.   "
173350|NCT00111111|"     The purpose of this multicenter, open-label, prospective study is to evaluate the     effectiveness and safety of etanercept in the treatment of subjects with psoriasis.   "
173351|NCT00111124|"     This study is testing the effect of etanercept in treating both the skin and joint symptoms     of psoriatic arthritis patients. Enbrel®, also known as etanercept, has already been approved     by the Federal Food Drug Administration for the treatment of psoriatic arthritis. It is taken     as an injection under the skin. Participants in the trial will be offered etanercept free of     charge to be self-injected once weekly for 24 weeks. During that period they will have 5     appointments at the study center and will also be asked to complete assessments of their     health.   "
173352|NCT00111137|"     The purpose of this study is to compare the time to hematopoietic response (hemoglobin     correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for     subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those     receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the     12-week comparative treatment period.   "
173353|NCT00111150|"     This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe     for sexually-active young adults in Botswana without HIV infection and whether it will reduce     their risk of getting an HIV infection.   "
173354|NCT00111163|"     The purpose of the study is to see whether antimalarial drugs administered at the time of     routine infant vaccinations prevents malaria and anemia in the first year of life.   "
173755|NCT00108303|"     Schizophrenia has long been known to be an illness with significant evidence for a genetic     predisposition. The purpose of this study is to determine the genetic abnormalities that     cause childhood and adult onset schizophrenia.   "
173355|NCT00111176|"     The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA     [Thoracic Aortic Aneurysm] Endovascular Graft) is a clinical trial approved by the United     States Food and Drug Administration (FDA) to study the safety and effectiveness of the Zenith     TX2 TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers.   "
173356|NCT00111189|"     The purpose of this study is to evaluate the efficacy of paliperidone palmitate compared with     placebo in the prevention of recurrence of the symptoms of schizophrenia and to assess the     safety and tolerability of paliperidone palmitate in patients with stable and symptomatic     schizophrenia. The placebo used in this study was a nutritional substance known as 20%     Intralipid emulsion given to patients requiring intravenous feedings.   "
173357|NCT00111202|"     This research is designed to investigate the perceptions and opinions of individuals who     either have schizophrenia or who have a family member with schizophrenia, in relation to     genetic counseling. Data will be collected via a 15 minute online questionnaire. There is     also an option for respondents to participate in a 45 minute interview if they wish.      It is expected that the study will show that adequate information about genetic counseling is     not provided to these individuals. It is also hoped that this research will help to make     genetic counseling sessions more specific to people with schizophrenia in their family.   "
173358|NCT00111215|"     The purpose of the study is to determine whether oral contraceptives, desmopressin acetate,     and/or tranexamic acid are effective in the treatment of women with menorrhagia who are     diagnosed with a bleeding disorder.   "
173359|NCT00111228|"     The objective of the study is to determine whether patients with poor glycemic control can     improve metabolic control using the real-time values of the Guardian® RT compared to     conventional self-monitoring blood glucose finger-sticks.   "
173360|NCT00111241|"     Many women with breast cancer are treated with a class of drugs called aromatase inhibitors     (mainly letrozole or anastrozole), which lowers the amount of estrogen being produced in the     body. Women on aromatase inhibitors appear to experience joint pains and arthralgia. The aim     of this study is to determine whether the joint pains experienced by some women on aromatase     inhibitors is associated with more defects in their cartilage, compared to women not     receiving this therapy. Using the magnetic resonance imaging (MRI) technique, the knee joint     will be examined to assess changes in cartilage volume over time.   "
173364|NCT00111293|"     The NIMH is conducting studies aimed at gaining a better understanding of the areas of the     brain that are involved in different types of mental processes. This study will focus on     brain regions involved in visual perception and attention.      Healthy normal volunteers and people who have had a stroke or undergone neurosurgery may be     eligible for this study. Candidates must be 18 years of age or older, They must not have a     history of a psychiatric disorder, including depression, anxiety, psychosis, or neurological     disease other than stroke or the previous neurosurgery.      Participants undergo the following tests and procedures during four or more visits to the NIH     Clinical Center:        -  Physical and neurological examinations and depression rating scale.        -  Cognitive testing: Subjects complete written tests, sit at a computer and make decisions          about what they are shown by pressing keys, or answer questions from a test examiner.        -  Behavioral training: Subjects practice performing a cognitive task that involves looking          at and making decisions about visual images that appear on a computer screen.        -  Magnetic resonance imaging (MRI): Subjects undergo MRI scanning while they perform the          task they previously practiced. The MRI scanner is a metal cylinder surrounded by a          strong magnetic field. During the procedure, subjects lie still for up to 10 minutes at          a time on a table that can slide in and out of the cylinder. The entire MRI scanning          session takes about one hour. There are multiple scans which each can take up to 10          minutes. They may be asked to return for one or two additional scanning sessions.      During the behavioral training or MRI scanning, special pieces of equipment that monitor eye     movements may be used.      Some subjects may be asked to return to NIH for an additional visit to participate in a     magnetoencephalographic scan. This test uses several sensors applied to the scalp to measure     very small changes in magnetic fields. This is another way to measure brain activity.   "
173365|NCT00111306|"     The purpose of the study is to evaluate the safety & efficacy of Epratuzumab with standard     treatments for patients with SLE.   "
173366|NCT00111319|"     The primary reason for this study is to determine whether the addition of VELCADE     (bortezomib) for injection to standard melphalan/prednisone (MP) therapy improves the time to     disease progression (TTP) in subjects with previously untreated multiple myeloma.   "
173367|NCT00111332|"     Lipodystrophy is characterized by increased cardiovascular disease. Limited strategies are     available to increase cardiovascular fitness in this population, particularly among women.     Progressive aerobic and resistance training will increase aerobic capacity and improve     strength in HIV positive women with lipodystrophy.   "
173368|NCT00111345|"     Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93     and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In     spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or     have even decreased. Against the background that about 40% of the patients still die from     immediate causes of an underlying disease relapse or of nonresponse, it seems to be     justifiable to intensify therapy - especially for high-risk patients - which on its parts     will require an optimization of supportive measures. As the present risk stratification into     standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the     risk-adapted therapy strategy.      The aim of the study is to improve prognosis in children with AML by intensification of     cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central     nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.   "
173500|NCT00114855|"     The purpose of this study is to determine to what degree Hypocol® (Red Yeast Rice) may lower     low density lipoprotein (LDL)-cholesterol in a European population. The effect of Red Yeast     Rice on fasting blood glucose and inflammatory markers will also be investigated.   "
173369|NCT00111358|"     This study is designed to determine the effects of an intensive lifestyle modification     program in patients with HIV and Metabolic Syndrome. The primary endpoints will be     improvement in body composition, specifically waist-to-hip ratio (WHR). The secondary     endpoints will include improvement of cardiovascular indices, such as total cholesterol,     low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride cholesterol     levels, blood pressure, cardiac enzymes, c-reactive protein (CRP), tissue plasminogen     activator (t-PA), plasminogen activator inhibitor (PAI), and insulin and glucose metabolism.     We expect that quality of life indices and life skills should also improve with the lifestyle     modification program.   "
173370|NCT00111371|"     This study aims to determine whether levodopa, in combination with a high frequency training     of (grammatical) rules, is effective in boosting learning success in healthy subjects and     whether this kind of training in combination with levodopa improves reading and spelling     abilities of patients with dyslexia.   "
173371|NCT00111384|"     This study may identify genes that predict the seriousness of neurofibromatosis type 1 (NF1).     Finding these genes may explain why some people with NF1 have more medical problems than     others. The study will also examine medical problems in NF1 that are rarely seen and are not     well understood.      Male and female patients with NF1 who have gone through puberty may be eligible for this     study, as well as patients of any age who have unique or under-recognized disease features.     Affected and unaffected family members, including parents, siblings, and more distant     relatives, may also be enrolled. Candidates are screened with a discussion of medical history     or review of medical records, or both. Participants undergo the following procedures:      Patients with NF1        -  Physical examination and family history        -  Photographs of the iris of each eye        -  Photographs of the back, abdomen and thigh to count skin tumors        -  Photographs of the face and body (with underwear on) to help track growth and appearance        -  Magnetic resonance imaging (MRI) of the spine (This test uses a magnetic field and radio          waves to look for tumors and curvature of the spine. The patient lies still in the          scanner, a narrow cylindrical device, wearing earplugs to muffle loud knocking sounds          that occur during the scan. A contrast material called gadolinium is injected into a          vein through a catheter to enhance the images.)        -  Blood draw for genetic studies        -  Possibly a skin biopsy (with the use of numbing medicine, removal of a small sample of          skin tissue) to grow cells in the laboratory      Patients with NF1 who have unique or under-recognized disease features        -  Physical examination and family history        -  Blood draw for genetic studies        -  Possibly a skin biopsy        -  Possibly additional tests, such as blood work, x-rays, photographs, MRIs, ultrasounds,          or other tests      Unaffected family members        -  Blood draw for genetic studies        -  Brief skin and eye examinations        -  Possibly a skin biopsy for cell culture      Families are asked to give permission for researchers to recontact them for follow-up     information, additional blood samples, or follow-up visit.   "
173384|NCT00111553|"     This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with     cutaneous leishmaniasis.   "
173385|NCT00111566|"     This trial was designed to examine the efficacy of a brief versus a standard prolonged (18     hours) infusion of eptifibatide in preventing troponin I release following successful     coronary stenting.   "
173386|NCT00111579|"     The purpose of this study is to describe the level of serum antibody conferred by CAIV-T and     TIV against homotypic and heterotypic influenza virus strains.   "
173410|NCT00103558|"     This is an open label, Phase I/II, dose escalation research study of an investigational     product called lumiliximab, given with FDA (Food and Drug Administration) approved products     fludarabine, cyclophosphamide, and rituximab (FCR). The study duration is 17 visits over 42     months or until your disease progresses and you require additional CLL therapy. The total     duration of participation in the study will be approximately 4 years, however your disease     status will be followed indefinitely (forever).   "
174325|NCT00122850|"     This study will examine duloxetine compared with placebo and an active comparator in the     treatment of generalized anxiety disorder.   "
173372|NCT00111397|"     Mycobacterium avium complex (MAC) are ubiquitous organisms that cause isolated pulmonary     disease in otherwise healthy patients with yet undefined susceptibilities. Patients typically     present with a history of chronic cough, eventually progressing to hemoptysis, fever, and     hypoxia. With half or more of all patients failing standard three-drug therapy, this is an     insidious disease with a poor prognosis. Under the natural history protocol of nontuberculous     mycobacterial infection (NTM; #01-I-0202), 46 patients with diagnosed pulmonary MAC disease     are being studied. Numerous studies have suggested that a dysregulation in cytokine     production may make these patients susceptible to mycobacterial infection. Cytokines are     particularly important in the activaction of macrophages, which help to clear mycobacterial     infection. Interferon gamma 1b (Actimmune) and GM-CSF (Leukine) are two cytokine therapies     that have been approved in the treatment of chronic granulomatous disease and     post-transplantation hematopoietic reconstitution, respectively. A number of in vitro studies     suggest that either or both of these therapies may help to clear MAC infection. Given the     poor outcomes of therapy and the persistent, debilitating nature of the disease, new     therapies are desperately needed, and many are being tried without benefit of scientific     foundation. Currently, there are no prospective trials that show any effect of these drugs in     the lung delivered subcutaneously. This protocol proposes to perform a pilot study to     evaluate the effects, if any, of these macrophage stimulating cytokines in the context of     ongoing pulmonary MAC infection.      Aims:      To determine the local and systemic effect, if any, of adjuvant IFN gamma and GM-CSF in     pulmonary MAC patients.      Methods:      Fifteen patients will be randomized into three treatment groups of five patients each. The     first group will receive a standard drug regimen, based on the 1997 ATS guidelines. The     second and third groups, in addition to receiving the standard therapy, will also receive     three months of (IFN{gamma}) and GM-CSF, respectively. All patients will undergo bronchoscopy     with bronchoalveolar lavage (BAL) at the beginning of the study, after three months, and at     six months.      In addition to obtaining traditional subjective and objective clinical measures, both     proteomic and genomic analysis of the BAL will be performed to determine if cytokine therapy     effects any detectable change in the lungs. In vitro studies on typ...   "
173373|NCT00111410|"     The purpose of this study is to estimate the effect of anakinra, 100 mg once daily (QD), on     the development of an anti-tetanus antibody response in subjects with RA after vaccination     with a tetanus and diphtheria toxoids injection. In addition, this study will evaluate the     general safety profile of therapy with anakinra, 100 mg QD, in subjects with RA after     vaccination with a tetanus and diphtheria toxoids injection.   "
173374|NCT00111423|"     The purpose of this study is to evaluate the safety of an additional 28 weeks of treatment     with pegsunercept for subjects who have completed treatment in a previous double-blind study     (20000201 or 20000198). In addition, this study will evaluate the efficacy and the     feasibility of subject self-administration on an outpatient basis.   "
173375|NCT00111436|"     The purpose of this study is to evaluate the safety and tolerability of long-term     administration of etanercept in adults with psoriasis who have participated in previous     etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy     of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis     studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly     (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72     weeks.   "
173376|NCT00111449|"     The purpose of this study is to determine the effect of etanercept 50 mg twice weekly     compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects     with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg     twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported     outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice     weekly.   "
173377|NCT00111462|"     The purpose of this study is to compare the effect of darbepoetin alfa administered in a     weight based versus fixed dosing for the treatment of anemia in subjects with non-myeloid     malignancies receiving multicycle chemotherapy.   "
173378|NCT00111475|"     The purposes of this study are: to determine a weekly dose that demonstrates a satisfactory     safety profile and sustains elevated platelet counts within a targeted therapeutic level (a     doubling of baseline platelet counts and within the range of greater than or equal to 50 x     10^9/L and less than or equal to 450 x 10^9/L in thrombocytopenic subjects with ITP; to     assess Amgen megakaryopoiesis protein 2 [AMP2 (AMG 531)] pharmacokinetics (PK) in     thrombocytopenic subjects with ITP.   "
173379|NCT00111488|"     The purpose of the Randomized Study of Surgical Ablation with Microwave Energy for the     Treatment of Atrial Fibrillation (RESOLVE-AF) trial is to determine the safety and     effectiveness of the Guidant FLEX® Microwave Surgical Ablation System in the treatment of     permanent atrial fibrillation (AF).   "
173380|NCT00111501|"     The overall goals of this line of research are to develop and evaluate innovative treatments     for lesbian, gay, bisexual, and transgender (LGBT) cigarette smokers and to understand the     processes related to smoking and relapse in this previously unstudied population of smokers.     In this study, participants are randomly assigned to one of two Internet-based smoking     cessation treatments: 1) a self-help intervention tailored LGBT smokers plus social support     plus email-based counseling, or 2) a standard self-help condition alone, similar to other     general smoking cessation treatments. Before starting the program, participants will complete     measures of smoking, nicotine dependence, depression diagnosis, demographics, mood,     motivation to change, and alcohol use. Smoking status will be determined at 1, 3, 6, and 12     months following the start of treatment. Data will be analyzed to compare the quit rates of     the two Internet-based treatment groups. Also, we will complete exploratory analyses to     determine those variables that best predict quitting for LGBT smokers.   "
173381|NCT00111514|"     The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given     as three injections every 28 days at each of three dose levels of Leish-111f protein, in     combination with standard pentavalent antimony therapy in adult patients with mucosal     leishmaniasis.   "
173382|NCT00111527|"     A suboptimal level of resynchronization (cardiac resynchronization therapy [CRT]) achieved in     many patients with actual standards and techniques based on tissue-Doppler echocardiography     could be more effective to obtain better CRT results. Eligible patients who successfully     received atrioventricular (AV) junction ablation and biventricular (BiV) pacing are     randomised to a comparison between a strategy of right ventricular (RV) apical pacing with     delayed CRT based on clinical indications with a strategy of early optimal CRT based on an     echocardiographic stratification.      End-points:        -  Acute echo comparison (acute echo study)        -  Quality of life and exercise tolerance (Short-term clinical study)        -  Composite end-point of CRT clinical failure (Long-term clinical study)   "
173383|NCT00111540|"     This open label study is designed to assess long term glucose control, as measured by     hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with     type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a     day.   "
173387|NCT00111592|"     Ageing and the availability of medication has led to an increase of elderly male patients     being treated for lower urinary tract symptoms (LUTS), or voiding problems (prostate     problems). However, guidelines are vague as to which patients should and which should not be     treated, and how.      Although several treatment modalities have proven efficacy in selected populations, it is     unclear how effective these treatments are in daily practice.      This study investigates the hypothesis that a treatment protocol in which clear indications     are formulated for all treatment modalities is more effective, as compared to current usual     primary care, in reducing both symptoms as related to the quality of voiding in elderly     males.   "
173388|NCT00111605|"     The purpose of this study is to evaluate the safety and tolerability of an experimental HIV     vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating     doses of 100, 500, and 1,500 mcg respectively), a substance that helps the body respond to a     vaccine. This study will also determine the safety and tolerability of an experimental HIV     vaccine boosted with two adjuvants.   "
173389|NCT00111618|"     The purpose of this trial is to confirm a safe dose of AS1404, to be given with docetaxel,     and to see whether adding AS1404 and docetaxel together improves the outcome of the     treatment, when compared to docetaxel alone.   "
173390|NCT00111631|"     This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients     with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study     treatment is 3-12 months and the target sample size is 100-500 individuals.   "
173391|NCT00111644|"     This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with     ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by     Legionella. The anticipated time on study treatment is 3-12 months and the target sample size     is 100-500 individuals.   "
173392|NCT00111657|"     The purpose of this study is to determine whether PEG-uricase (a chemically modified     recombinant mammalian enzyme that degrades uric acid) is effective in controlling     hyperuricemia in patients with chronic gout, who cannot tolerate, or have not responded     adequately, to conventional therapy for gout.      Funding Source - FDA OOPD   "
173393|NCT00111670|"     This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to     placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3     months and the target sample size is 100-500 individuals.   "
173394|NCT00111683|"     In this study participants with relapsed/refractory leukemia will be given MK-0457 in     sequential cohorts and with varying treatment duration to determine the maximum tolerated     dose (MTD) for MK-0457.   "
173395|NCT00111696|"     To describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant     melanoma.   "
173396|NCT00111709|"     The purpose of this study is to test the effectiveness of a marketed drug in the treatment of     a menstrual migraine attack.   "
173397|NCT00111722|"     The purpose of this study is to test the effectiveness of a marketed drug in the treatment of     a menstrual migraine attack.   "
173398|NCT00111735|"     The aim of the study is to examine the effects of fine titration of thyroxine dosage on     symptoms of hypothyroidism, wellbeing and quality of life. The hypothesis is that symptoms of     hypothyroidism, wellbeing and quality of life will be improved in thyroxine-treated subjects     when serum thyrotropin (TSH) is suppressed and/or in the lower reference range, compared to     when TSH is in the upper reference range.   "
173399|NCT00111748|"     The main goal of this study is to evaluate the effectiveness of the combination of these     drugs, and whether they can be given safely together.   "
173402|NCT00111787|"     This Study was designed to determine how effective and safe a new investigational drug,     lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed     inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of     treatment and at the time of surgical resection will be examined for pathologic response and     biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of     14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib     and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and     physical exams will be performed throughout the study to monitor safety.   "
173403|NCT00111800|"     This is a 24-week study investigating the safety and efficacy of several dosages of a     potential new oral medicine for Type II diabetes mellitus.   "
173404|NCT00111813|"     The purposes of this study are:        -  To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and          bortezomib in participants with advanced multiple myeloma        -  To assess the safety and tolerability of this regimen and to document the participant's          clinical status (by anti-tumor activity) for this combination, as determined per          standard of care.   "
173405|NCT00111826|"     The purpose of this study is to assess the effects of the Celacade™ system in patients with     intermittent claudication.   "
173406|NCT00111839|"     This study is planned to answer questions about how the drug, matuzumab (EMD 72000), works     and is part of an effort aimed to develop better treatment for advanced lung cancer by     combining matuzumab, a monoclonal antibody, with a chemotherapy treatment, called pemetrexed.     Pemetrexed is commercially available and has been approved for treatment of locally advanced     or metastatic non-small cell lung cancer that could not be successfully treated with other     chemotherapy.      The study aims to examine how non-small cell lung cancer (NSCLC) responds to matuzumab in     combination with pemetrexed, as compared with giving pemetrexed alone. The study also aims to     examine how safe and effective matuzumab is and for how long it stays in the body     (pharmacokinetics). Matuzumab is an experimental treatment which is currently only available     for research studies.   "
173407|NCT00111852|"     The purpose of this study is to evaluate desmoteplase (which is a manufactured protein     derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of     blood through one (or more) of the blood vessels supplying the brain, thereby reopening the     blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic     stroke.   "
173408|NCT00111865|"     Objectives: The primary objective of this trial is to determine the effect of aerobic     exercise training (AET) on change in quality of life (QoL) in lymphoma survivors receiving     and not receiving chemotherapy. Secondary objectives are to determine the effects of AET on     changes in psychosocial outcomes, cardiopulmonary fitness, body composition, and treatment     completion rates.   "
173412|NCT00103584|"     This is a Phase I/II study evaluating the safety and immunogenicity of LC16m8, a modified     vaccinia vaccine. After consent and thorough screening (including safety labs, EKG, and     medical history), healthy, previously unvaccinated volunteers between the ages of 18-34 will     receive a single vaccination of either LC16m8 or the current US-licensed smallpox vaccine,     Dryvax. Volunteers will be blindly randomized to a treatment group in a 4:1 ratio (4 LC16m8     to 1 Dryvax recipient). Follow-up clinical evaluations, laboratory testing, EKGs and cardiac     assessments will be done at regularly scheduled follow-up visits for 1 year after     vaccination.   "
173413|NCT00103597|"     Patients with Parkinson's Disease or Multiple System Atrophy (MSA), and symptoms of     orthostatic hypotension, are eligible for the study. Each patient will have three weeks of     conservative therapy, three weeks of therapy with fludrocortisone, and three weeks of therapy     with domperidone. Autonomic testing, a symptom questionnaire, bedside blood pressure testing,     and Unified Parkinson Disease Rating Scale (UPDRS) will be performed after each intervention.   "
173414|NCT00103610|"     The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and     granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF     alone to mobilize and collect the optimal number of stem cells in non-Hodgkin's lymphoma     patients for autologous transplantation.   "
173415|NCT00103623|"     Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV     commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated     population of patients receiving Plenaxis®. The purpose of the study is to estimate the     incidence of immediate-onset systemic allergic reactions in the indicated population     receiving Plenaxis® and to determine whether the hazard rate changes over time.   "
173416|NCT00103636|"     The purpose of this study is to investigate the effects of extending the dwell time of     peripheral intravenous cannulas on clinical outcomes and cost.   "
173417|NCT00103649|"     The purpose of this study is to assess xaliproden's potential capacity of slowing the     deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's     disease. The patients participating in this study will take orally once daily xaliproden or     placebo (inactive substance pill).   "
173418|NCT00103662|"     The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and     granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than     G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma     patients for autologous transplantation.   "
173419|NCT00103675|"     The purpose of this study is to develop and test a sensor system capable of measuring     acupuncture needle manipulation and torque in a clinical setting.      Study hypothesis: Torque will be greater on the side of the back with musculoskeletal pain     compared with the side without pain.   "
173420|NCT00103701|"     The purpose of this clinical research study is to understand the safety and efficacy of     BMS-354825 in patients with chronic, accelerated, or blast phase chronic myelogenous leukemia     (CML) or Philadelphia positive acute lymphoblastic leukemia (ALL) who are resistant to or     intolerant of imatinib mesylate (Gleevec).   "
173421|NCT00103714|"     The objectives of this study are to evaluate the safety, tolerability and preliminary     efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in     patients with cystic fibrosis (CF) lung disease.   "
173422|NCT00103727|"     This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective     compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative     symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks     and will then return for a follow-up visit 2 weeks later. About 275 patients with     schizophrenia will be enrolled in this study.   "
173423|NCT00103740|"     The primary objective of this core study was to show non-inferiority of zoledronic acid to     risedronate, with respect to the proportion of patients who achieved therapeutic response.     The extended observation period included participants of the core study who responded to     treatment.   "
173424|NCT00103753|"     Thalassemia major is a genetic disorder affecting hemoglobin synthesis, rendering individuals     dependent upon lifelong blood transfusions. Consequently, iron overload occurs and patients     have shortened life expectancy with the most common cause of death being heart failure. This     trial tests whether the combination of traditional therapy (deferoxamine) with a newer drug     (deferiprone) will prove more effective in removing cardiac iron than deferoxamine alone.   "
173425|NCT00103766|"     The purpose of this study is to assess the benefit to patients with empyema or complicated     parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two     different dose strategies compared with saline placebo.   "
173426|NCT00103779|"     This is an open-label, multi-dose, Phase I, dose escalation study to define the safety     profile and preliminary anti-tumor activity of SGN-40 in patients with refractory or     recurrent non-Hodgkin B-cell lymphomas.   "
173427|NCT00103792|"     The purpose of this study is to determine the efficacy and safety of a new drug,     mycophenolate mofetil, for the treatment of relapses of ANCA-associated vasculitis (Wegener's     granulomatosis or microscopic polyangiitis). Therefore, we compare the standard therapy with     cyclophosphamide to mycophenolate mofetil.      The investigators expect mycophenolate mofetil to be less toxic and almost equally effective     as cyclophosphamide.   "
173428|NCT00103805|"     The purpose of this study is to determine whether the non-daily administration of levodopa is     effective in boosting semantic language acquisition in healthy subjects.   "
173429|NCT00103818|"     The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia     (a sleep disorder).   "
173430|NCT00103831|"     A phase I-II dose ranging study of BMS-275183 (oral taxane) in combination with pemetrexed     (Alimta) in patients with recurrent Non-Small Cell Lung Cancer (NSCLC). The safety and     efficacy of this combination will be studied.   "
173431|NCT00111878|"     The primary objective of this study is to describe the safety and tolerability of a single     dose of MEDI-534 when administered to healthy adult volunteers.   "
173432|NCT00111891|"     This is a 3-week trial in normal healthy or lipid clinic patients studying a novel approach     to treating dyslipidemia.   "
174326|NCT00122863|"     This is a clinical trial assessing the time to relapse of anxiety symptoms among patients     with generalized anxiety disorder who have responded to duloxetine therapy.   "
173433|NCT00111904|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with     unresectable locally advanced or metastatic pancreatic cancer.   "
173434|NCT00111917|"     The goal of this research study is to test the clinical effectiveness of a drug called     infliximab (Remicade) in chronic beryllium disease (CBD). This drug may reduce tumor necrosis     factor-alpha (TNF-a), which is associated with more severe disease and inflammation in the     lung. Receiving infliximab may help with symptoms, and may improve clinical testing data     normally ordered by your doctor, such as breathing tests. Baseline and follow-up testing will     look for improvements in breathing tests (pulmonary function testing), exchange of oxygen in     the lungs (exercise test), chest x ray, and lung inflammation.   "
173435|NCT00111930|"     The purpose of the study is to examine whether DHEA replacement therapy is associated with     beneficial changes in body composition (i.e., increases in lean mass and bone mass, and     decreases in fat mass).   "
173436|NCT00111943|"     The purpose of this study is to determine the safety and acceptability of a vaginal     microbicide in HIV uninfected sexually active women.      Study hypothesis: The vaginal microbicide 1% tenofovir will be safe and well tolerated in HIV     uninfected women who are in good general health.   "
173437|NCT00111956|"     Metabolic syndrome is associated with increased inflammatory cytokines and reduced     adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned     that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin,     improving the inflammatory milieu associated with metabolic syndrome.   "
173438|NCT00111969|"     The purpose of this study is to test the safety and efficacy of the Celacade™ system in     reducing the risk of mortality and cardiovascular hospitalizations in patients with chronic     systolic heart failure.   "
173439|NCT00111982|"     The purpose of this study is to determine long-term efficacy of continuous IPu liatermin     infusion administered with concomitant standard anti-Parkinsonian therapy.   "
173440|NCT00111995|"     This study is designed to evaluate the hemoglobin response to Aranesp® (darbepoetin alfa) in     black subjects (African-Americans) with chronic renal failure (CRF) receiving hemodialysis     and to examine the safety profile.   "
173441|NCT00112008|"     The proposed study is designed to test a novel dosing paradigm that would facilitate the     treatment of anemia in CKD patients not on dialysis. Anemic patients who are not currently     receiving ESA therapy will be dosed with darbepoetin alfa Q2W for 18 weeks.   "
173443|NCT00112034|"     The purpose of this study is to determine the efficacy and safety of combination therapy with     AVONEX plus low dose oral methotrexate (MTX), every other month courses of intravenous     methylprednisolone (IVMP), or both in patients with continued disease activity on AVONEX     monotherapy.   "
173444|NCT00112047|"     The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified     antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1     (HIV-1) infected participants. The primary objective of the study was to assess     noninferiority of emtricitabine (FTC) and tenofovir disoproxil fumarate (tenofovir DF; TDF)     in combination with efavirenz (EFV) relative to Combivir (CBV) in combination with EFV in the     treatment of HIV-1 infected ART-naive participants, determined by the achievement and     maintenance of confirmed HIV-1 ribonucleic acid (RNA) < 400 copies/mL (c/mL) through Week 48,     as defined by the United States (US) Food and Drug Administration (FDA)     time-to-loss-of-virologic-response (TLOVR) algorithm.   "
173445|NCT00112060|"     This phase I/II, multi-centered, non-randomized trial is designed to determine a safe dose of     PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy     in subjects with NSCLC.   "
173446|NCT00112073|"     The purpose of this study is to assess the safety and tolerability of multiple doses of     AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).   "
173447|NCT00112086|"     A feasibility study of neoadjuvant chemotherapy (NAC) followed by interval cytoreductive     surgery (ICS) and postoperative chemotherapy for stage III/IV mullerian carcinomas such as     ovarian, tubal and peritoneal carcinomas.   "
173448|NCT00112099|"     The purpose of this study is to evaluate the role of splenectomy in potentially curative     total gastrectomy for proximal gastric carcinoma in terms of survival benefit and     post-operative morbidity.   "
173449|NCT00112112|"     The main purpose of this study is to get information about the safety of a flu vaccine spray,     called FluMist, in children with cancer. The study is also being done to find out how much     and how long the vaccine spray can be found in the nose.   "
173450|NCT00112125|"     The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe     and effective in patients with moderate to severe heart failure symptoms.   "
173451|NCT00112138|"     The purpose of this study is to evaluate the effectiveness and safety of gabapentin compared     to placebo in the treatment of hot flashes in postmenopausal women using a phase III     randomized controlled trial.   "
173452|NCT00112151|"     The purpose of this study is to evaluate the effects of testosterone supplementation     (AndroGel) on body composition, strength, endurance, cognition, and function in older men.   "
173453|NCT00112164|"     The purpose of this study is to test the efficacy of activated Protein C (Xigris) for     improving clinical outcomes in individuals with acute lung injury (ALI).   "
173454|NCT00112177|"     Itopride is a new compound that is already marketed in Japan and in some countries of Eastern     Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia.     Patients suffering from this condition have difficulties digesting food. They feel full after     eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to     see if itopride helps to relieve the symptoms of functional dyspepsia.   "
173455|NCT00112190|"     Itopride is a new compound that is already marketed in Japan and in some countries of Eastern     Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia.     Patients suffering from this condition have difficulties digesting food. They feel full after     eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to     see if itopride helps to relieve the symptoms of functional dyspepsia.   "
173456|NCT00112203|"     Itopride is a compound already marketed in Japan and in some countries of Eastern Europe     under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients     suffering from this condition have difficulties digesting food. Patients feel full after     eating; they have bloating and have stomach pain. The goal of this study is to see if     itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.   "
173457|NCT00114283|"     This phase II trial studies how well lapatinib ditosylate works in treating patients with     metastatic or recurrent head and neck cancer. Lapatinib ditosylate may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth.   "
173458|NCT00114296|"     RATIONALE: Chemoprevention is the use of certain drugs or supplements to keep cancer from     forming, growing, or coming back. The use of omega-3 fatty acids may prevent breast cancer.      PURPOSE: This randomized clinical trial is studying how well omega-3 fatty acids work in     preventing breast cancer in women at high risk of developing breast cancer.   "
173459|NCT00114309|"     This drug is being developed to treat a type of brain cancer, glioma. This study was     developed to evaluate the safety, time to disease progression and survival rates after     treatment.   "
173460|NCT00114322|"     Recurrent fall/winter major depression (known as Seasonal Affective Disorder (SAD)) is a     prevalent and disruptive disorder whose pathophysiological basis is unknown, but several     hypotheses attribute a causal role to the circadian timing system. Bright white light     exposure via the retina has been shown to reverse the symptoms of SAD. Recent physiological     studies demonstrated the existence of retinal ganglion cells capable of transducing light     input to the retinohypothalamic tract, the primary circadian afferent in humans. This     retinohypothalamic system appears to be maximally sensitive to light in the 446-477nm     (violet/blue) range.      Using light-emitting diode (LED) technology, light of narrow bandwidths now can be delivered     from a safe, relatively inexpensive device. We propose to contrast in SAD patients the     efficacy and tolerability of 468 nm LED light from a portable 11cm x 6cm     commercially-available device (GoLITEÔ) to a broader 400-700 nm wavelength LED-generated     light housed in an identical device. The broad wavelength (white) light from our LED device     is similar to that from cool-white fluorescent 10,000 lux devices currently the standard for     treatment of SAD (see e.g., Lam & Levitt, 1999).      Twenty-four depressed SAD outpatients will be randomized to a 3-week trial of light therapy     using either the narrow 468 nm LED source or the broader 400-700 nm LED source, each housed     in a GoLITEÔ device. Subjects will be given devices and written instruction for administering     daily treatments at home, 45min every (q) a.m. The devices will be described to subjects in     terms of wavelength but not specifically described as blue or white. Weekly depression     ratings and assessments of adverse effects will be obtained by a trained rater blind to the     treatment condition. Depressive symptoms will be rated weekly by the same trained clinician.      The following hypotheses will be evaluated:        -  H1-- Depressed SAD patients will demonstrate greater antidepressant therapeutic benefit          from the narrow-wavelength (blue) source than from the broad-wavelength (white) source.        -  H2-- Depressed SAD patients will manifest fewer adverse effects during treatment with          the narrow-wavelength (blue) source than with the broad-wavelength (white) source.   "
173533|NCT00115284|"     The purpose of this study is to determine whether having physicians evaluate their management     of certain diseases as part of board recertification results in improved patient care.   "
173461|NCT00114335|"     This small cross-sectional epidemiological study is designed to evaluate the prevalence of     the following parameters in hospitalized patients in a tertiary teaching hospital (medical     department only):        -  kidney insufficiency        -  obesity        -  use of unfractionated heparins / low molecular weight heparins        -  other drugs effecting the hemostatic system   "
173462|NCT00114348|"     The protocol ALL-REZ BFM 2002 aims at the optimization of treatment for children with     relapsed acute lymphoblastic leukemia. The primary objective of study ALL-REZ BFM 2002 is the     randomized comparison of a lower dosed and less intensive, but continuous consolidation     therapy with conventional therapy administered in treatment blocks. Outcome measures are the     reduction of minimal residual disease (MRD), event-free and overall survival, and the     toxicity associated with each treatment strategy.   "
173463|NCT00114361|"     The purpose of this study is to investigate whether in patients with chronic HBeAg-negative     hepatitis B, PEG-IFN-ribavirin combination therapy for 1 year leads to enhanced response (HBV     DNA <10E4 copies/ml and normal ALT 24 weeks after treatment discontinuation) in comparison     with pegylated interferon (PEG-IFN) monotherapy.   "
173464|NCT00114374|"     The purpose of this study is to examine the efficacy of escitalopram compared to placebo in     reducing Acute Stress Disorder (ASD) symptoms and in preventing the emergence of     Post-Traumatic Stress Disorder (PTSD) in patients with medical trauma who are at risk for the     development of PTSD based on the presence of ASD symptoms.   "
173465|NCT00114387|"     The purpose of this study is to examine whether vitamin E (DL-alpha-tocopherol)     supplementation will reduce the progression of early atherosclerosis in healthy individuals     over 40 years of age with low-density lipoprotein (LDL) cholesterol levels greater than or     equal to 130mg/dL.   "
173466|NCT00114400|"     The purpose of this study is to examine whether vitamin B supplementation will reduce the     progression of early atherosclerosis in individuals over 40 years old and without clinical     evidence of cardiovascular disease (CVD).   "
173467|NCT00114413|"     The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures     exhaled nitric oxide (eNO) to indicate disease progression is more effective in treating     asthma symptoms when combined with existing asthma treatment guidelines than treatment using     the guidelines alone.   "
173468|NCT00114426|"     In this proposal, we will implement a randomized controlled trial to determine whether     nocturnal NIMV applied for 3 months: 1) improves (disease-specific) health related quality of     life (HRQL) of COPD patients compared to a control group of patients treated with sham NIMV     therapy (primary outcome); 2) improves exercise tolerance and walking capacity of COPD     patients; and 3) improves heart rate variability and decreases sympathetic tone in COPD.   "
173469|NCT00114439|"     This trial will examine the efficacy of lithium in providing symptomatic relief from the     withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular     use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can     be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from     such symptoms may be important in helping some clients achieve a period of abstinence and     facilitate subsequent entry into a relapse prevention program.   "
173470|NCT00114452|"     The purpose of the study is to determine whether adult stem cells [Provacel™(PUMP1)] are safe     and possibly effective in the treatment of acute myocardial infarction (heart attack).   "
173506|NCT00114933|"     Lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been     undetectable for six months while on triple drug antiretroviral therapy. Lopinavir/ritonavir     pharmacokinetics might prevent resistance development in patients who experience virological     rebound after single-drug simplification.   "
173471|NCT00114465|"     The primary objective of the study is to compare the efficacy of the probiotic VSL#3 versus     placebo, in addition to standard maintenance drugs, in maintaining remission in Crohn's     disease (CD).      The secondary objectives are:        -  To determine the time till flare of CD patients on VSL#3 compared to placebo.        -  To assess whether concurrent therapy with VSL#3 leads to an improvement in the quality          of life (QOL).        -  To assess whether concurrent therapy with VSL#3 reduces the severity of a flare if it          occurs.   "
173472|NCT00114478|"     The purpose of this study is to see which of the two most common drugs used to treat     bronchiolitis works better. A child's participation in this study is expected to last less     than 4 hours. Approximately 600 patients will be recruited to participate in this study at     Kern Medical Center (KMC).      Bronchiolitis is a very common lung infection in babies. There are many drugs used to treat     this disease but nobody knows which one, if any, works the best. Two of the most commonly     used drugs are albuterol and epinephrine. These are both drugs given during breathing     treatments with oxygen and a mask. We are doing this study to see which of these drugs works     better or if they are both equally good. The study works as follows: after the consent     process the baby gets three treatments.        -  Nebulizer 1 (Treatment)        -  Treatment + 30 minutes (approximately) Nebulizer 2        -  Treatment + 60 minutes (approximately) Nebulizer 3        -  Treatment + 120 minutes (approximately)      The baby will be reevaluated and either discharged home or revert to standard therapy. If the     baby is discharged directly from the emergency department (E.D.), we will call you in three     days time to see how he/she is doing.   "
173473|NCT00114491|"     Recent studies support the hypothesis that aortic stenosis (AS) develops due to     atherosclerosis affecting the aortic valve endothelium. The study’s aim was to assess     Rosuvastatin on the hemodynamic progression and inflammatory markers of AS by treating     low-density lipoprotein (LDL) in patients with AS according to the National Cholesterol     Education Program Adult Treatment Panel III (NCEP-ATPIII) guidelines for one year.   "
173474|NCT00114504|"     The purpose of this study is to determine whether FDG-PET is capable of detecting     atherosclerotic plaque inflammation and monitoring the effects of statins on plaque     inflammation. The usefulness of FDG-PET in risk stratification is also investigated.   "
173475|NCT00114517|"     The purpose of this study is to examine the effects of oral 17B-estradiol (estrogen) on the     progression of early (subclinical) atherosclerosis and cognitive decline in healthy     postmenopausal women.   "
173476|NCT00114530|"     SCOT is a clinical research study designed for people with severe forms of scleroderma. SCOT     stands for Scleroderma: Cyclophosphamide Or Transplantation. The SCOT study will compare the     potential benefits of stem cell transplant and high-dose monthly cyclophosphamide (Cytoxan)     in the treatment of scleroderma.   "
173783|NCT00108706|"     The aim of this study is to determine whether it is safe and effective to give the     Angiotensin Receptor Blocker (ARB) Candesartan within the first 72 hours following acute     stroke.   "
173477|NCT00114543|"     This multi-center, randomized clinical trial compared different bilirubin levels as     thresholds for timing of phototherapy in extremely low birth weight infants. The primary     hypothesis was that there would be no difference in death or neurodevelopmental impairment at     18-22 months corrected age in infants treated by either aggressive or conservative threshold     limits. 1,978 infants were enrolled.   "
173478|NCT00114556|"     Following liver transplantation, rapid bone loss occurs, particularly within the first 6     months post-transplant. This may be associated with fractures, most notable vertebral. The     ability to assess osteoporosis therapies in this system may provide useful information for     osteoporosis management in general.      Hypotheses:        1. That treatment with the bisphosphonate, zoledronate, at the time of liver          transplantation and at 1 month post-transplantation will prevent the early          transplant-related bone loss (measured by bone densitometry and biochemical bone markers          at 3 months) seen in patients who are not treated with a bisphosphonate        2. That continuing treatment with zoledronate at 3 monthly intervals for a total duration          of 12 months will result in further improvements in bone density beyond that seen at 3          months        3. That calcium and vitamin D (vit D) supplementation of liver transplant patients does not          prevent marked bone loss following transplantation.   "
173479|NCT00114569|"     The purpose of this study is to gather the data to: 1) determine the best dose, and 2)     evaluate its effectiveness and safety in stopping seizures. Part 1 is a pharmacokinetic study     (study of how much drug is found in the body after it is given through a vein and how fast     the body gets rid of the drug).   "
173480|NCT00114582|"     Optimizing the social and physical ambiance during mealtimes in Dutch nursing homes:     implementation and evaluation of the effect with respect to quality of life, nutritional     status and physical performance.   "
173481|NCT00114595|"     Tardive dyskinesia is a common complication of conventional antipsychotic treatment in     subjects with schizophrenia. This study investigates whether the addition of the omega-3     fatty acid, ethyl-eicosapentaenoic acid (EPA) to usual treatment improves movement disorder     in 84 schizophrenia subjects with established tardive dyskinesia. The initial double-blinded,     randomised trial duration is 12 weeks, followed by further 46 weeks of open-label treatment.   "
173482|NCT00114608|"     Electrical stimulation of the foot can increase blood flow out of the leg. This increased     blood flow can prevent blood clots from forming in the leg veins.      Blood clots in the leg veins can break off and form life-threatening blood clots in the     lungs.      Intermittent external pneumatic (air) compression of the foot is already used to increase     blood flow in at risk patients.      Hypothesis: Electrical stimulation of the foot increases blood flow out of the legs to the     same degree as intermittent external pneumatic (air) compression of the foot.   "
173483|NCT00114621|"     This study will examine the recombinant, that is, produced by genetic engineering, protective     antigen (rPA) that brings about antibodies to neutralize the anthrax toxin and that could     therefore be predicted to offer protection against anthrax. Today, anthrax is rarely     encountered in the United States, since the introduction of vaccines for cattle in the 1930s.     A human vaccine was licensed in 1970. Vaccination against anthrax has been confined to people     at risk, such as wool sorters and some veterinarians. However, the rising prospects of B.     anthracis being used as a weapon have led to routine administration of the anthrax vaccine to     members of the armed forces.      Adults who are in good health may be eligible for this study. The involvement of 300 adults     is planned.      Participants will have a general physical exam and test for vital signs. There will also be     collection of blood for chemistry and hematology; urinalysis; tests for HIV, hepatitis B and     C, and liver function; and a pregnancy test, if applicable.      On a random basis, patients will receive one of the rPA formulations. Two doses of rPA will     be evaluated, 10 microgram ((Micro)g) and 20 (Micro)g. This evaluation aims to establish the     safety and most desirable level of dosage. Patients will receive one injection of the     vaccine, administered in the left shoulder or left thigh. About 30 minutes later, their     temperature will be taken, and the injection site will be inspected. Rare but severe     reactions could occur if there is extreme sensitivity to a vaccine. However, such an     occurrence is extremely rare following a vaccine, and if there are any dangerous symptoms,     they can be effectively treated by medications available to patients while they are at the     clinic. If there are no significant abnormal results, patients may return home. About 6 hours     later and daily for 7 days, they will take their temperature and examine the injection site.     The vaccine may cause temporary discomfort at the site of injection, and participants may     experience a mild fever for 1 or 2 days after vaccination.      Patients will receive diary cards, a digital thermometer, and instructions on taking their     temperature and measuring redness and swelling at the injection site, as well as for     recording aches, muscle pain, or sensitivity to light for 7 days. They will be examined at     the clinic at 72 hours following vaccination and also on the 7th day if they have a fever at     or above 100.4 , if swelling is at or more than 2 inches, or if they request an exam.     Meanwhile, a clinic staff member will call patients and discuss the findings. Then patients     will receive a second and third injection of the same vaccine at 2-month intervals. There     will also be interviews about patients' health at each visit to the clinic, plus monitoring     of the vaccination after 6 hours and for 7 days. One year later, patients will receive a     fourth injection of the same vaccine.      Direct benefit to participants in this study is not guaranteed, although an antibody response     is predicted. The results in this study will help in the development of improved vaccines for     anthrax.   "
173507|NCT00114946|"     This is a randomized, open-label, active-control, multicenter trial comparing two     oxaliplatin/Avastin-based treatment sequences as first-line therapy for metastatic colorectal     cancer. The study is designed to compare the efficacy of these two treatment sequences with     respect to progression free survival (PFS) and overall survival.   "
173560|NCT00115635|"     The aim of the study is to determine the optimal dose of the combination of docetaxel and     gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with     respect to efficacy and toxicity in a phase II trial.   "
173484|NCT00114634|"     This 10-week study will evaluate and compare behavior changes in children with     Smith-Lemli-Opitz syndrome (SLOS) who are taking cholesterol supplementation versus those who     are not on cholesterol supplementation. SLOS is a genetic disorder that affects the     development of children both before and after birth. An enzyme deficiency in these children     results in low levels of cholesterol, which can cause a variety of birth defects and     behavioral problems. Typical abnormal physical features of patients include a small head,     drooping eyelids, small upturned nose, small chin, cleft palate, heart defects, and extra     fingers or toes.      Children between 5 and 17 with mild SLOS who do not have a history of egg allergy or     intolerance may be eligible for this study. Candidates are screened with a questionnaire     about the patient's age, genotype (if known), sterol levels, symptoms, current treatment and     medical history.      Children participate in two 2-week study phases. Between the study phases the children will     take 150 mg/kg daily of a cholesterol preparation typically used to supplement cholesterol in     patients in SLOS studies at NIH. In the study phases, the participants are randomly assigned     to take either egg yolk or an egg yolk substitute, such as Egg Beaters, that does not contain     cholesterol. The study is done at the participant's home, and the cholesterol supplementation     and egg/egg substitute are sent to the home each day with instructions on how to take them.      The caretakers can stop the study phases after four days if behavior problems occur.      The children's caretakers fill out a standard behavioral questionnaire, the Aberrant Behavior     Checklist. The questionnaire is designed to assess the effects of treatment in mentally     impaired persons.   "
173485|NCT00114647|"     This study will collect blood plasma and white blood cells from individuals using a procedure     called apheresis. Apheresis is a method of collecting larger quantities of certain blood     components that can safely be collected through a simple blood draw. The blood components     will be used in laboratory research studies.      Patients 18 years of age and older who are currently enrolled in a NIH clinical research     protocol may participate in this study. Relatives of patients and normal healthy volunteers     will also be enrolled.      Individuals will undergo one of the following two apheresis procedures:        -  Automated pheresis Blood is drawn through a needle placed in an arm vein and circulated          through a cell separator machine. The plasma (liquid part of the blood) and white cells          are extracted, and the red cells are re-infused into the donor through the same needle          or a needle in the other arm. An anticoagulant (medication to prevent blood from          clotting) is usually added to the blood while in the machine to prevent it from clotting          during processing.        -  Manual pheresis One unit (1 pint) of blood is drawn through a needle placed in an arm          vein, similar to donating a pint of whole blood. The red blood cells, with or without          plasma, are separated from the rest of the blood and returned to the donor through the          same needle. Manual pheresis will be done only when a person s estimated total blood          volume or red cell count is too low to safely permit removal of blood through a pheresis          machine. An adult small in size or markedly anemic, for example, may fall into this          category.      Some of the blood collected through apheresis may be stored for future studies of HIV disease     and immune function and for HLA testing, a genetic test of markers of the immune system. Some     of the blood may be used to screen for different types of viral liver infections, such as     hepatitis A, B, C, D, E, F, or G.   "
173486|NCT00114660|"     This study will check to see if using cocoa butter lotion on the belly, breasts and thighs     will help reduce the appearance of stretch marks in pregnancy. Women entering the study will     either receive a lotion containing cocoa butter with vitamin E or a lotion containing only     vitamin E. After delivery, the study investigators will evaluate whether the women who used     cocoa butter lotion were less likely to develop stretch marks.   "
173487|NCT00114673|"     Skin chronically exposed to the sun may become damaged and then develop wrinkles and/or     uneven skin color. The purpose of this research study is to evaluate a newly developed scale     (grading tool) that rates wrinkles and uneven skin color. This newly developed scale will be     used in future topical drug studies to measure these changes in the skin.   "
173488|NCT00114686|"     The purpose of this study is to determine whether treatment with Quetiapine Fumarate     (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps     patients who have Bipolar I Disorder with Alcohol Dependence   "
173489|NCT00114699|"     This is a phase 1, randomized, placebo-controlled, dose-escalation study of CCR5mAb004 in     HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy.     Subjects will be randomly assigned to receive a single intravenous (IV) infusion of one of     four dose levels of CCR5mAb004 or matching placebo. A minimum of 10 subjects will be     randomized to each cohort at a ratio of 4:1 (active:placebo). A minimum of 40 and maximum of     60 subjects will be enrolled. This study will be conducted at up to 10 sites in the United     States.      Subjects in each cohort will be followed for 56 days after study agent administration. The     safety, tolerability, and immunogenicity of CCR5mAb004 will be evaluated based on physical     examination, adverse event (AE) reporting, and clinical laboratory tests. Blood will be     collected at specified times for the determination of CCR5mAb004 serum concentrations, HIV-1     RNA levels, and CD4+ and CD8+ cell counts. If CD4+ cell counts are less than 200 during the     study period, the subject should be offered standard-of-care per HIV treatment guidelines     that may include the initiation of appropriate anti-retroviral therapy (AVR). CCR5mAb004     pharmacokinetic (PK) and pharmacodynamics (PD) will be measured over the 56-day study period.     Anti-CCR5mAb004 antibody titers will be assessed prior to dosing on Day 0 and on Day 28 and     Day 56.   "
173490|NCT00114712|"     Ribavirin should be avoided during pregnancy and during the 6 months before pregnancy in both     the female and the male sexual partner. If a pregnancy occurs and is reported to the     Ribavirin Pregnancy Registry, the Registry will follow the pregnant woman throughout     pregnancy. The Registry will also follow the infant until 1 year of age. The goal of the     Registry is to learn more about the effects of ribavirin on pregnancy and the risk for birth     defects. Pregnant women exposed to ribavirin, either by taking ribavirin (during pregnancy or     6 months before pregnancy) or through a male sexual partner (who took ribavirin during the     female partner's pregnancy or during the 6 months before pregnancy), are encouraged to     contact the Registry.   "
173491|NCT00114725|"     Laser-assisted intracytoplasmic sperm injection (ICSI) has been suggested as a more effective     alterative to conventional ICSI when this method of insemination is indicated for patients     undergoing in vitro fertilization (IVF). Laser-assisted ICSI differs from conventional ICSI     in that a laser is used to drill a small hole through the hard outer coating surrounding an     egg before the injection needle containing a single sperm is inserted into the egg. The hole     eliminates compression of the egg that normally occurs with conventional ICSI, and thus may     reduce the chance of damage. Laser-assisted ICSI is hypothesized to result in increased egg     survival, and perhaps improved embryo quality, compared to conventional ICSI.   "
173492|NCT00114738|"     This study will evaluate the effectiveness of EPOCH-R chemotherapy plus bortezomib for     treating mantle cell lymphoma, a cancer of white blood cells called lymphocytes. EPOCH-R     consists of the drugs prednisone, etoposide, doxorubicin and vincristine, with the addition     of a new drug called rituximab. In a recent study of patients with newly diagnosed mantle     cell lymphoma, 92 percent had a complete remission of their disease after treatment with     EPOCH-R. This study will test whether adding bortezomib as maintenance therapy once     chemotherapy is finished will lengthen the time before the disease relapses and improve the     overall cure rate.      Patients 18 years of age and older with mantle cell lymphoma may be eligible for this study.     Candidates are screened with a medical history and physical examination, blood and urine     tests, electrocardiogram, MUGA or echocardiogram, imaging studies and biopsy to determine the     extent of disease, and possible colonoscopy.      Participants undergo treatment in three parts, as follows:        -  Part 1: Bortezomib alone: Patients receive 4 doses of bortezomib over 3 weeks. The drug          is injected into a vein over about 30 seconds.        -  Part 2: EPOCH-R chemotherapy plus bortezomib: This phase of treatment begins 3 to 4          weeks after completing Part 1. Treatment is given on an outpatient basis in six 3-week          cycles, with all drugs administered over the first 5 days of each cycle. Patients take          prednisone by mouth on days 1 to 5 and etoposide, doxorubicin, and vincristine as a          96-hour infusion through a vein over days 1 to 5. The infused drugs are delivered          through a lightweight, portable infusion pump. Rituximab is given by vein over several          hours on day 1 immediately before the chemotherapy infusion begins. Bortezomib is given          by vein over 30 seconds on day 1 before the rituximab and again on day 4.          Cyclophosphamide is given by vein over about 15 minutes on day 5 immediately after the          chemotherapy infusion is completed. Patients are taught how to self inject G-CSF, a drug          that helps boost white cell counts after chemotherapy. They inject the drug under the          skin (like an insulin shot) for 10 days of each cycle beginning day 6. Patients also          take an antibiotic to help prevent infection during chemotherapy.        -  Part 3: Bortezomib alone: After completing EPOCH-R-B therapy, patients are randomly          assigned to receive or not to receive bortezomib alone. The drug is given in 2 doses          over 5 days, with a break of 16 days before the next dose. These 3-week cycles continue          for up to 18 months or until the disease comes back or worsens. Patients who are          assigned to the group that does not receive bortezomib will be offered the drug if their          disease relapses.      During therapy, patients have tests performed on their bone marrow, tumor tissue, blood or     other fluids to look at different genes and proteins that may be involved in the development     of their lymphoma or the reaction of the immune system. A tissue biopsy is done before     treatment begins and a day after treatment starts. Disease progress is followed with CT scans     and blood tests. When treatment is completed, patients whose cancer has disappeared are     scheduled for periodic follow-up examinations and tests. Those whose disease remains or     recurs may be offered participation in another protocol if an appropriate one is available or     are returned to the care of their local physician.   "
173561|NCT00115648|"     The purpose of this study is to determine if extended antiretroviral regimens given to the     infant during the first 14 weeks of age would decrease breast milk transmission of HIV.   "
173495|NCT00114790|"     Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique which is     based on the principle of irradiating boron atoms with neutrons. When neutrons have     relatively low energy, boron atoms that have been targeted to cancerous tissue using a     suitable boron carrier (an amino acid derivative called BPA, boronophenylalanine) will     capture the neutrons. As a result from the neutron capture the boron atoms will split into     two, producing helium and lithium ions. The helium and lithium ions, in turn, have only a     short pathlength in tissue (about 5 micrometers) and will deposit their cell damaging effect     mainly within the tumor provided that the boron carrier (BPA) has accumulated in the tumor.     In practice, the study participants will receive BPA as an approximately 2-hour intravenous     infusion, following which the tumor is irradiated with low energy (epithermal) neutrons     obtained from a nuclear reactor at the BNCT facility. BNCT requires careful radiation dose     planning, but neutron irradiation will last approximately only for one hour. In this study     BNCT will be repeated, and the 2 treatments will be given 3 to 5 weeks apart. The study     hypothesis is that head and neck cancers that have recurred following conventional     radiotherapy might accumulate the boron carrier compound, and might respond to BNCT.   "
173496|NCT00114803|"     The hypothesis underlying this study is that nasally administered calcitonin will stabilize     or improve bone mineral density in young patients with ulcerative colitis or Crohn's disease.     Patients who participate will receive either calcitonin or placebo and will have their bone     mineral density measured at the start, at nine months, and at 18 months of study.     Participants will also receive age appropriate doses of vitamin D and calcium supplements.     Other serological measures of vitamin D status will be obtained every 3 months during the     study.   "
173497|NCT00114816|"     This study compares two chemotherapy regimens as adjuvant treatment for breast cancer. The     study participants are randomly allocated to receive either 3 cycles of docetaxel followed by     3 cycles of CEF (cyclophosphamide, epirubicin and 5-fluorouracil) or to receive 3 cycles of     docetaxel plus capecitabine followed by 3 cycles of CEX (cyclophosphamide, epirubicin and     capecitabine). The study participants are required to to have a medium to high risk for     breast cancer recurrence. The primary aim of the study is to investigate whether addition of     capecitabine to a standard taxane/anthracycline regimen will influence recurrence-free     survival.   "
173498|NCT00114829|"     The purpose of this study is to determine whether a colonic tumor can be classified as     malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon     carcinoma or benign tumor based on diverticulitis are offered a MR colonography with     intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the     dynamic contrast uptake and morphology. The Investigator is blinded from the verified     diagnosis and the MR classification is compared to the histological diagnosis.   "
173499|NCT00114842|"     The purpose of this study is to determine if MR colonography with fecal tagging is better     using air or water for distension of the colon. Patients referred to colonoscopy are offered     MR colonography before colonoscopy. Two days before colonography, patients ingest a 200 ml     Barium sulfate solution 2% four times a day, which will render fecal masses invisible on     the following MR colonography. Air or water (randomised trial) is used for distension of the     colon. The examinations are evaluated by two independent blinded readers.   "
173501|NCT00114868|"     This study was a randomized, community-based trial testing whether dosing newborn infants in     the first few days after delivery with a large dose of vitamin A could reduce early infant     morbidity, mortality and improve growth. Pregnant women in 2 districts of Tamil Nadu State in     southern India were identified and recruited for participation. When the child was born,     study staff were notified and traveled to the house to collect information and provide the     vitamin A or placebo dose. Children were visited every two weeks until they were 6 months of     age to collect information about vital status and morbidity. All children were discharged     from the study at 6 months after growth was assessed and they received a 100,000 IU dose of     vitamin A.   "
173502|NCT00114881|"     The purpose of this study is to determine the way environmental factors (like the components     of inner-city household dust) affect immune system development and symptoms of asthma in     inner city children. The study is divided into three periods, as the subjects age from birth     to 10 years old. Each age bracket will explore different objectives and endpoints.      Study Objectives/Hypotheses:        1. Subjects age 0 to 3 years old:             -  Environmental factors in the inner city adversely influence the development of the               immune system to promote cytokine dysregulation, allergy, and recurrent wheezing by               age 3.             -  Children who have had a viral lower respiratory infection and have developed               cytokine dysregulation by age 3 are at increased risk for the development of asthma               by age 6.        2. Subjects age 4 to 7 years old:             -  There is a unique pattern of immune development that is driven by specific urban               exposures in early life, and this pattern of immune development is characterized               by: 1) impairment of antiviral responses and 2) accentuation of Th2-like responses               (e.g. cockroach-specific Interleukin-13(IL-13)). The clinical effects of these               changes in immune development are frequent virus-induced wheezing and allergic               sensitization by 3-4 years of age, and these characteristics synergistically               increase the risk of asthma at age 7 years.        3. Subjects age 7 to 10 years old:             -  There are unique combinations of environmental exposures (cockroach allergens,               indoor pollutants [Environmental Tobacco Smoke (ETS) and Nitrogen Dioxide (NO2)],               lack of microbial exposure), and family characteristics (stress, genetic factors               related to innate immunity) that synergistically promote asthma onset, persistence,               and morbidity in urban neighborhoods. These exposures and characteristics influence               immune expression and lung development during critical periods of growth, resulting               in specific asthma phenotypes.        4. Subjects age 10 to 16 years old:             -  To determine the wheezing, asthma and atopy phenotypes in minority children growing               up in poor urban neighborhoods as they develop from birth through adolescence.   "
173503|NCT00114894|"     Jellyfish stings are a common occurrence among ocean-goers worldwide with an estimated 150     million envenomations annually. Fatalities and hospitalizations occur annually, particularly     in the Indo-Pacific regions. A new topical jellyfish sting inhibitor based on the mucous     coating of the clown fish prevents 85% of jellyfish stings in laboratory settings. The field     effectiveness is unknown. This is a field test to determine the real world effectiveness.   "
173504|NCT00114907|"     It is proposed to investigate the association between consumption of black tea and various     selective fasting blood serum and urine biomarkers in a Mauritian population with ischaemic     heart diseases. This study, the first of its kind, will provide clinical data on the     potential prophylactic propensities of Mauritian black tea against cardiovascular disease,     which remains one of the major health threats to the Mauritian population.   "
173505|NCT00114920|"     The primary purpose of this study is to evaluate the effectiveness in adults, of four     different strengths of resiquimod gel applied to common wart(s) three times a week for twelve     weeks.      A second purpose is to evaluate the safety of the drug.   "
173562|NCT00115661|"     The purpose of this study is to perform a pilot study on the efficacy of rosiglitazone in     reducing pelvic pain in early stage endometriosis patients.   "
173508|NCT00114959|"     This will be an open label, multi-center study of up to 77 patients with CML in chronic,     accelerated or blast phase who have developed resistance to or have failed previous treatment     with Gleevec (imatinib mesylate). Because these patients may still be sensitive to Gleevec,     adding Homoharringtonine may restore a response to Gleevec or the combined treatment may     promote a better response than using Gleevec alone.   "
173509|NCT00114972|"     The SYNTAX trial is designed to determine the best treatment for patients with complex     coronary disease (blocked or narrowed arteries in both the right and left sides of the heart)     by randomizing patients to receive either percutaneous coronary intervention (PCI) with     polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).   "
173510|NCT00114985|"     During 3D-conformal external beam radiation therapy treatments for prostate cancer, the     prostate gland moves. The purpose of this study is to determine whether the placement of a     prostate immobilization device into the rectum during radiation treatments will decrease the     risk of rectal bleeding that is sometimes seen as a late effect from radiation.   "
173511|NCT00114998|"     To study cardiac and vascular structure and function in a population of adolescents with type     2 diabetes mellitus (T2DM) compared to a similar group with obesity alone and a similar     non-obese group.   "
173512|NCT00115011|"     The purpose of this study is to determine the effectiveness of escitalopram in treating     self-injurious skin picking.   "
173513|NCT00115024|"     The purpose of this study is to determine the effects of estrogen replacement therapy (ERT)     on the progression of early atherosclerosis in healthy postmenopausal women without     preexisting cardiovascular disease (CVD).   "
173514|NCT00115037|"     This is a study involving treatment for alcohol dependence (alcoholism). The study will     combine motivational enhancement therapy and cognitive behavioral therapy (combined     behavioral intervention, or CBI) and tests the benefits of continued/discontinued treatment     with naltrexone in a randomized placebo-controlled trial. CBI may have advantages in     motivating patients to greater medication adherence and may address psychosocial factors that     may limit the effects of naltrexone.   "
173515|NCT00115050|"     This is an open-label safety study to provide early access to TMC114 for HIV-1 infected     patients who have failed and exhausted regimens based on commercially available     antiretroviral (ARV) therapy and who are ineligible for participation in any other     Tibotec-sponsored trial.   "
173534|NCT00115297|"     This study will determine the effects of montelukast on the duration of wheezing in children     12 months to 3 years of age who visit a physician for care of a wheezing illness. Only     patients from the Ankara area of Hacettepe University Medical Center in Turkey will be     included in this study.   "
173516|NCT00115063|"     LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for     individuals with extreme obesity (body mass index [BMI] 40-60 kg/m2). The intensive medical     treatment is designed to produce 25% weight loss from baseline and to maintain at least 20%     weight loss from baseline. The intensive medical treatment is compared to a usual care     treatment model where individuals utilize self directed approaches to weight loss. The active     treatment period is three years, followed by two years of observation.   "
173517|NCT00115076|"     Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is     to study the action and the effects of Efalizumab, on psoriasis. This medication has been     studied extensively and has been found to be effective and safe in the treatment of     psoriasis. The eligible patient will have 10% of his/her body surface area involved with     psoriasis vulgaris.   "
173518|NCT00115089|"     This is a study of the effectiveness and safety of a new nasal spray for the relief of the     symptoms of seasonal allergies. The agents being compared are: R926112 (a novel anti-allergy     medicine), Beconase (beclomethasone dipropionate, an established FDA approved steroid     treatment), and an inactive placebo. The study hypothesis is that R926112 will be superior to     placebo at the end of a week of testing and evaluation. The study does not have the power to     determine how R926112 compares to Beconase.   "
173519|NCT00115102|"     This project examines experimental pain and chronic pain in the mouth, specifically the     condition called atypical odontalgia (AO:atypical toothpain). In 16 patients with AO and 16     healthy persons, capsaicin (chili-pepper) is applied to the gingiva to cause pain. This pain     is evaluated by the participants. In three sessions, 3 different medications are tested for     effect on the pain. The medications are fentanyl, S-ketamine and placebo-treatment (saline).     The aim is to know more about pain mechanisms in AO in order to develop an effective     treatment.   "
173520|NCT00115115|"     Donor pre-treatment with dopamine reduces injury to the kidney graft with consequences on the     clinical performance immediately after transplantation: Donor dopamine reduces the     requirement of dialysis post transplant, and results in renal function improvements.      The purpose of the study is to investigate the potentially therapeutic impact of donor     preconditioning with low dose dopamine in human renal transplant recipients from a brain dead     donor.   "
173521|NCT00115128|"     The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by     filgrastim in normal donors.   "
173522|NCT00115141|"     The primary purpose of this study is to evaluate the effectiveness in adults, of four     different strengths of resiquimod gel applied to common wart(s) three times a week for four     weeks.      A second purpose is to evaluate the safety of the drug.   "
173523|NCT00115154|"     The purpose of this study is to evaluate the safety and efficacy of imiquimod 5% cream     compared to vehicle cream in the treatment of Actinic Keratosis (AK) on the arm and/or hand     when the cream is applied once daily 2 days per week for 16 weeks.   "
173524|NCT00115167|"     The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of     treatment in subjects with anemia of cancer who are not receiving chemotherapy.   "
173559|NCT00115622|"     The purpose of the study is to compare the efficacy and safety of an investigational nasal     spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis.     Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following     allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of     allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly     referred to as hay fever, it is characterized by sneezing, nasal congestion and pruritus,     rhinorrhea, and pruritic, watery, red eyes.   "
173525|NCT00115180|"     We aim to compare pain management among three groups of ethnic disparity (ED) patients,     Hispanics, non-Hispanic Blacks, non-Hispanic Whites, and assess whether the observed     association between pain management and race/ethnicity is independent of potentially     important confounding variables (e.g., age, sex, insurance status, education). We also aim to     assess whether the effect of race/ethnicity on adequacy of pain management is explained by     patients' initial pain intensity or by discordance between patient and physician's: a)     race/ethnicity; b) perception of patient's pain. To do this 285 patients with long-bone     fractures will be recruited in the EDs of one municipal and one voluntary hospital serving an     inner-city, disadvantaged population in the Bronx. Data will be collected on pain using     self-reported pain and non-verbal pain expressions at baseline, one hour post-baseline, and     discharge. Data on analgesics administered, patient and physician characteristics will also     be collected.      We plan to conduct a chart review of long bone fractures in 2000 and 2001 so that we can     analyze the association between race/ethnicity and pain management using the same design as     published studies. Comparison of the retrospective and prospective studies will strengthen     inferences that can be drawn.      We hypothesize that Black and Hispanic patients will be less likely to receive opioid     analgesics than white patients.   "
173526|NCT00115193|"     The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when     administered on the same day versus the next day of chemotherapy, as measured by the duration     of grade 4 neutropenia.   "
173527|NCT00115206|"     The purpose of this study is to estimate the relationship between patient reported outcomes     (PROs) and neutropenia (or its complications) in NSCLC subjects receiving chemotherapy with     or without Neulasta® (pegfilgrastim).   "
173528|NCT00115219|"     The purpose of this study objective will be to evaluate the efficacy and safety of etanercept     50 mg BIW in RA subjects who showed a sub-optimal response to standard dose etanercept (50 mg     QW) and concomitant methotrexate therapy.   "
173529|NCT00115232|"     The purpose of this study is to evaluate levels of inflammatory mediators in children at risk     for cardiovascular disease due to family history. We are measuring inflammatory markers in     two groups of children and their parents: children with a family history of early     atherosclerotic heart disease (cases), and healthy children without such a family history     (controls). The design is a cross-sectional study, gathering a fasting blood sample and     clinical and behavioral data on children and a parent.   "
173530|NCT00115245|"     This research study is being conducted to compare the safety and effectiveness of the     investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by     the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The     results for patients taking LdT will be compared to results for patients taking adefovir     dipivoxil.   "
173531|NCT00115258|"     The purpose of this study is to determine which method of providing parenteral nutrition     (complete intravenous nutrition) will provide the best nutritional and clinical results to     children undergoing hematopoietic stem cell transplantation.   "
173532|NCT00115271|"     The purpose of this study was to determine the effects of providing supplements containing     alternative combinations of micronutrients during pregnancy on birth weight and other infant     and maternal health and nutritional outcomes in a rural area of Nepal.   "
173538|NCT00115349|"     The purpose of this study is to determine whether left ventricular function improves more     rapidly with deferoxamine (DFO) and deferiprone (L1) combination therapy than with DFO     monotherapy in patients with thalassemia and decreased ejection fractions. Secondary aims     include evaluating changes in myocardial iron burden using T2* and estimating the relative     incidence and severity of chelator-induced toxicity.   "
173539|NCT00115362|"     The purpose of this study is to investigate whether Efexor (venlafaxine) is effective in the     treatment of functional dyspepsia.   "
173540|NCT00115375|"     PICOLO is a double blind placebo controlled phase II dose ranging, dose escalating study in     patients of Blalock-Taussig age categories (neonates and infants/toddlers), to determine the     dose providing inhibition of platelet aggregation similar to adults.   "
173541|NCT00115388|"     Chlamydial infection is a common, sexually transmitted disease which women can have without     knowing. Untreated, it can lead to an infection of the womb and fallopian tubes called pelvic     inflammatory disease (PID), which can cause infertility. There has been only one trial of     chlamydia screening and this was in American women in 1992 and used outdated tests. We now     need to see if screening using modern tests and self-taken swabs works in a high risk, young,     multiethnic female population in the United Kingdom (UK).      The study is a randomised trial. It will involve asking women students in college bars to     complete confidential questionnaires on sexual health and to provide self-administered     vaginal swabs. We have successfully done this in a small pilot study. Participants will be     told that the tests are for research purposes only and that if they think they may have been     at risk of a sexually transmitted infection they should get checked at a clinic. If the trial     shows that chlamydia screening using these new methods prevents PID, extending this     community-based intervention nationwide could improve women's reproductive health and     wellbeing and might prevent some women from becoming infertile   "
173542|NCT00115401|"     This study will collect information on the different ways that people walk, that is, their     gait, when they use ankle braces. Patients will visit NIH on at least three and as many as     nine separate occasions. A physical therapist will perform a physical examination to     determine how patients move, how strong they are and what their comfortable walking speed is.     Then patients will sit on a chair while a camera apparatus takes special pictures of their     legs, a procedure lasting up to 2 hours. Patients will be asked to return to learn how to     walk with the custom Passive Dynamic Ankle-Foot Orthosis (PD-AFO)-a unique ankle brace     designed to improve walking ability by providing natural support to the lower limb.      Patients 4 and older who are in good health and able to walk repeatedly a distance of 15     meters (approximately 49 feet) independently and unsupervised may be eligible for this study.      With this training, patients may return several times to learn how to walk with the brace,     but for their protection, they will not be allowed to take it or use it outside the research     team's supervision. The researchers will examine the leg to ensure that the brace fits and     will ask questions about it. Each training visit will require up to 1.5 hours. When patients     have learned to walk with the brace, they will be asked to visit again and walk while     scientific pictures are taken of their legs. During the walking test, patients will wear     T-shirts and shorts. Patients' arms and legs will be wrapped with a soft, rubber-like     material, to allow small plastic reflective balls to be attached. Firm material known as a     shell can be attached to the rubber sleeves, with Velcro or a self-sticking bandage. The     small balls may also be attached to the skin, with an adhesive. Also, there may be a test of     the muscles, through the use of electromyography, or EMG. The test involves attachment of     small metal electrodes to the surface of the skin, again with an adhesive. There should not     be discomfort with that test.      As patients walk several times, scientific cameras will record the positions of the     reflective balls. Pictures do not involve patients' faces or other parts of the body.     Afterward, a unique chair system called a Biodex will measure the leg muscle strength.     Patients will be asked to sit on the chair and place their leg in a foot in an apparatus, a     special structure that measures strength. They will repeatedly push against the apparatus,     doing so for 3 seconds. Each time patients push, the researchers will touch a small magnetic     device to the skin, which will cause the muscles to push harder. Although this procedure     should not cause any discomfort, it may feel unusual. If they wish, patients can ask to stop     the test at any time. Few risks are involved in participating in this series of activities.     There is a slight chance of mild skin irritation from the adhesives used on the skin or from     the soft, rubber-like material. But the material is worn for only a brief period, and skin     reactions are rare. Also, that material may feel tight, but if it causes discomfort or     prevents moving, patients can ask a researcher to adjust it. There is a slight chance of skin     irritation from use of the PD-AFO, but adjustment can be made to make patients comfortable.     Patients may experience some muscle soreness caused by participating in the muscle strength     tests. However, they will be safely monitored by a physical therapist when they try on the     brace to adjust to its feel and fit, as well as during testing of gait.      This study will not have a direct benefit for participants. However, participants will be     paid for their time, with minimum compensation of $50.   "
173543|NCT00115414|"     The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when     administered on the same day versus the next day of chemotherapy, as measured by the duration     of grade 4 neutropenia.   "
173544|NCT00115427|"     This randomized study was designed to evaluate the efficacy and safety of IPu-infused     liatermin (15mg/putamen/day) compared with placebo in subjects with symptomatic,     levodopa-response Parkinson's disease. This study consisted of a 90-day evaluation period     followed by implantation of the IPu delivery system and then a 6-month double-blind treatment     period.   "
173556|NCT00115583|"     The purpose of the study is to assess the importance of a substance called endothelin.     Endothelin is produced by coronary arteries. This study examines this substance to determine     whether it has an effect on controlling blood flow in coronary arteries. When these arteries     release too much endothelin, the blood flow to the heart muscle is reduced and this may be     important in heart conditions. This protocol examines an investigational drug called BQ-123     to see if it blocks the effect of endothelin. We assess the blood flow in the coronaries and     evaluate the effects of BQ-123. It is anticipated that this endothelin blocker will open up     coronary arteries and increase the blood flow to the heart.   "
173545|NCT00115440|"     Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique which is     based on the principle of irradiating boron atoms with neutrons. When neutrons have     relatively low energy, boron atoms that have been targeted to cancerous tissue using a     suitable boron carrier (an amino acid derivative called BPA, boronophenylalanine) will     capture the neutrons. As a result from the neutron capture the boron atoms will split into     two, producing helium and lithium ions. The helium and lithium ions, in turn, have only a     short pathlength in tissue (about 5 micrometers) and will deposit their cell damaging effect     mainly within the tumor provided that the boron carrier (BPA) has accumulated in the tumor.     In practice, the study participants will receive BPA as an approximately 2-hour intravenous     infusion, following which the tumor is irradiated with low energy (epithermal) neutrons     obtained from a nuclear reactor at the BNCT facility. BNCT requires careful radiation dose     planning, but neutron irradiation will last approximately only for one hour. In this study     BNCT is given once. The study hypothesis is that anaplastic astrocytomas and glioblastomas     that have recurred following conventional radiotherapy might accumulate the boron carrier     compound, and might respond to BNCT.   "
173546|NCT00115453|"     Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique that is     based on the principle of irradiating boron atoms with neutrons. When neutrons have     relatively low energy, boron atoms that have been targeted to cancerous tissue using a     suitable boron carrier (an amino acid derivative called BPA, boronophenylalanine) will     capture the neutrons. As a result from the neutron capture the boron atoms will split into     two, producing helium and lithium ions. The helium and lithium ions, in turn, have only a     short pathlength in tissue (about 5 micrometers) and will deposit their cell damaging effect     mainly within the tumor provided that the boron carrier (BPA) has accumulated in the tumor.     In practice, the study participants will receive BPA as an approximately 2-hour intravenous     infusion, following which the tumor is irradiated with low energy (epithermal) neutrons     obtained from a nuclear reactor at the BNCT facility. BNCT requires careful radiation dose     planning, but neutron irradiation will last approximately only for one hour. In this study     BNCT is given only once. The study hypothesis is that glioblastoma tissue may accumulate the     boron carrier compound, and glioblastoma might respond to BNCT.   "
173547|NCT00115466|"     This comparative, multicentre, randomised clinical trial is designed with two parallel groups     that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem     Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the     non-surgical treatment of complex perianal fistula.   "
173548|NCT00115479|"     In a previous study, we showed that tight blood glucose control with insulin during intensive     care reduced morbidity and mortality of surgical intensive care patients. Whether this     intervention also improves prognosis of medical intensive care patients remains unknown. The     current prospective, randomized, controlled study will assess the impact of intensive insulin     therapy on the outcome of patients in a medical intensive care unit. On admission, patients     will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with     intensive insulin therapy or the conventional approach, in which insulin infusion is     initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between     180 and 200 mg/dl.   "
173549|NCT00115492|"     This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary     Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the     clinic 10 times. Subjects will be given breathing tests and will record their breathing     symptoms daily on diary cards. All study related medicines and medical examinations will be     provided at no cost. The two drugs used in this study have been approved by FDA for use in     patients with COPD.   "
173839|NCT00116909|"     Multi-center, Phase II study to evaluate the efficacy and safety of OSI-7904Lin head and neck     cancer in patients who have failed first-line therapy   "
173550|NCT00115505|"     This research trial studies quality of life, employment, and informal care cost analysis in     patients with breast cancer receiving chemotherapy. This trial assesses how quality of life     has been affected by cancer, if cancer and its treatment have caused in changes in the     patient's or their spouse's employment and how they have affected the patient and their     extended family, and the impact of peripheral neuropathy caused by chemotherapy on quality of     life. Learning about quality of life and informal care costs may help doctors better     understand how patients feel during treatment, what effects the medicines are having, and in     the future may help both patients and doctors as they decide which medicines to use to treat     cancer.   "
173551|NCT00115518|"     The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in     non-operable NSCLC Stage III (Phase II trial).      Endpoints:      safety and feasibility (primary) response, survival, time to progression (secondary)   "
173552|NCT00115531|"     The purpose of this study is to compare a new higher-dose influenza virus vaccine to the     standard dose vaccine in elderly adults who can walk. Current influenza vaccines protect     elderly against viral influenza but not as well as desired. It is expected that the higher     doses vaccine can be given with little reaction, but this needs to be tested. Up to 410     people ages 65 years and older will be recruited from the community and from existing     volunteer populations. Participants will receive either the high or standard dose injected in     the muscle, remain in the clinic for 20 minutes afterward, and maintain a daily memory aid     for 7 days. The memory aid will be reviewed by telephone 8-12 days after the injection and     return to the clinic or contacted by telephone 6 months after the injection.   "
173553|NCT00115544|"     The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in     infants who are at risk for an exchange transfusion and meet the criteria of the protocol.   "
173554|NCT00115557|"     The major goal of this project is to determine the effectiveness of a multi-component     intervention designed to help primary care practices implement three office system strategies     known to increase delivery of immunizations and other preventive services. This two-year     study will contribute to our understanding of multi-component translational interventions in     primary care, and particularly within practice-based research networks.   "
173555|NCT00115570|"     The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and     effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with     type 1 diabetes mellitus.   "
173563|NCT00115674|"     The purpose of this study is to understand the smoking behavior of female incarcerated     smokers and to determine how smokers differ from non-smokers on measures of substance abuse,     personality, criminal history, and mental illness   "
173564|NCT00115687|"     Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even     with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely     exceed 20%. These low quit rates may be due to inadequate treatment of the physical     dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal     symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However,     little information is available on the safety or efficacy of medications to treat pregnant     smokers.      The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in     promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled     trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6     week taper) or a matching placebo. Women who are doing well at the end of the trial will also     be offered gum post-partum for relapse prevention.   "
173565|NCT00115700|"     Patients with stage I and II low grade follicular lymphoma are randomised between standard     therapy (involved field radiotherapy) and investigational therapy (involved field     radiotherapy and chemotherapy plus rituximab). The main endpoint is progression free survival     but overall survival and the influence of t(14;18) status will also be studied.   "
173972|NCT00119717|"     The purpose of this study is to assess the safety and efficacy of the NeuroFlo™ catheter for     use in patients with ischemic stroke. The NeuroFlo device is intended to increase blood flow     to the brain and potentially reduce the damage caused by stroke.   "
173566|NCT00115713|"     The purpose of this study is to compare the effects of two different types of exercise,     aerobic exercise training (AET) and resistance exercise training (RET), on quality of life     (QoL) in early stage breast cancer survivors receiving chemotherapy. It is hypothesized that     both AET and RET would have beneficial effects on QoL.   "
173567|NCT00115726|"     The purpose of this study is to determine whether continuing or discontinuing furosemide (a     diuretic) on the day of elective noncardiac surgery for those who take furosemide on a     chronic basis, causes more intraoperative hypotension (low blood pressure) during surgery.     Our hypothesis is that the usual practice of continuing furosemide on the day of surgery     would contribute to more hypotension during surgery than discontinuing furosemide.   "
173568|NCT00115739|"     Anaplastic thyroid cancers are rare, aggressive tumors. Standard treatment options include     surgery and chemoradiation. Few treatment options are available once metastases develop.     Recent data suggest that Imatinib (Gleevec) may be advantageous in this patient population.     Patients who have been treated for anaplastic thyroid cancer with chemoradiation or surgery     who develop recurrent or metastatic disease outside of the field of radiation are eligible.     Patients will be treated with Imatinib 400 mg two times a day for eight weeks, followed by     radiologic assessment. Patients will be treated until disease progression or a complete     response is obtained.   "
173569|NCT00115752|"     This study will evaluate how genetic makeup contributes to the variation in people regarding     their sensitivity to and experience of pain. Scientists believe that differences in     information found in genes may explain why an analgesic drug, that is, one that treats pain,     works effectively for some people but not for others. The study will explore pain that is     acute (fast and short period). Knowledge gained from this ongoing study may permit     development of an individualized analgesic drug prescription.      Patients ages 16 to 35 who are in good health and have been referred for removal of impacted     wisdom teeth; who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs     (known as NSAIDs), sulfites, or certain anesthetics; who are not pregnant or nursing; and who     are willing to have a biopsy before and after dental surgery are eligible for this study.      Patients will come to the clinic for one test visit and one treatment visit. During the first     visit, a questionnaire will evaluate patients' psychological state, including mood and     depression. There will be a clinical examination of their wisdom teeth. A blood sample of 10     milliliters (about 0.4 ounces) will be collected from the forearm to provide DNA material     containing genes stored in cells. The primary genetic analysis will be done at NIH, although     the DNA collected might also be sent to a laboratory outside NIH. DNA samples will be coded     so that names of patients cannot be traced.      During the second visit, two of the patients' lower wisdom teeth will be removed. Patients     will be given a local anesthetic in the mouth and a sedative given through a vein in the arm.     While the mouth is numb, a small piece of tissue will be removed from inside the cheek, near     the wisdom tooth. It is the first biopsy. After the two wisdom teeth are removed, a small     piece of tubing will be placed into both sides of the mouth where the teeth were removed.     Every 20 minutes, for the next 3 hours, the researchers will collect inflammatory fluid from     the tubing, to measure the chemicals thought to cause pain and swelling. Also every 20     minutes, patients will rate the pain they feel by answering questions. If there is pain     before 3 hours following surgery, they will receive a dose of fentanyl to relieve moderate to     severe pain. A second biopsy will occur 3 hours after surgery, to measure changes in     chemicals produced in response to surgery. Immediately afterward, patients will receive 30 mg     of ketorolac (Toradol) whether or not pain is felt. They will answer questionnaires about     pain for 3 hours after receiving the drug, to rate how well it works. They will stay at the     clinic up to 6 hours after the surgery. If pain is not relieved with ketorolac, patients will     receive a one-time dose of tramadol, a pain medication for moderate to severe pain. After the     study procedures are completed, patients will receive pain medication for pain after surgery.      Patients will be monitored closely, because all drugs have side effects. Ketorolac is a     nonsteroidal anti-inflammatory drug, one that may cause gastrointestinal upset. Fentanyl is a     powerful narcotic drug that is safe at the dosage used in this study, but stomach upset,     dizziness, and breathing trouble may occur. Also, risks from the biopsy include discomfort     from injecting the numbing medicine, infection, and bleeding. There may be discomfort from     the sedative injected into the vein, and there may be bruising.      Benefits from participating are having wisdom teeth removed at no cost as well as close     monitoring before and after surgery. There are no plans to give patients the results of     genetic tests or questionnaires. Years of research may be needed before such information has     the chance to become meaningful.   "
173570|NCT00115765|"     The purpose of this study is to assess whether treatment with the study drug, panitumumab     given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab     improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based     chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or     irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive     concomitant panitumumab therapy.   "
173571|NCT00115778|"     The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent     bacterial infections in lung transplant patients with low serum levels of immunoglobulin.   "
173572|NCT00115791|"     The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with     placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.   "
173573|NCT00115804|"     The purpose of this research is to conduct an open, pilot trial to assess the efficacy and     safety of fluoxetine in the treatment of Juvenile Primary Fibromyalgia Syndrome (JPFS).   "
173574|NCT00115817|"     The purpose of the study is to evaluate the effects of Atorvastatin.      The investigators want to find out if atorvastatin has other helpful qualities. The     investigators are interested in finding out if medicines like atorvastatin are useful even in     people who do not have high levels of bad cholesterol and would like to understand other     mechanisms by which this medicine helps prevent further blood vessel disease.      Hypotheses:        1. Atorvastatin reduces Rho kinase activity (in leukocytes) rapidly, within days, in          patients with atherosclerosis.        2. Any decrease in Rho kinase activity with statin therapy will be accompanied by          improvement in familiar markers of atherosclerosis.   "
173575|NCT00115830|"     The purpose of the study is to investigate the effects of atorvastatin (Lipitor) and     rosuvastatin (Crestor), United States Food and Drug Administration (FDA) approved drugs     commonly prescribed by doctors to lower cholesterol, on certain functions of platelets (cells     that cause blood clots), white blood cells (cells that are responsible for inflammation), and     blood flow regulation by arteries. This is important because we are looking at ways to more     effectively prevent atherosclerosis (plaque buildup in blood vessels) and heart disease. Many     studies have demonstrated that these drugs are effective at reducing inflammation and     stabilizing plaques. We are interested in better understanding the effects of these medicines     on inflammation (pain and swelling) and the mechanism by which they act.      Hypothesis: Atorvastatin (40mg) will reduce inflammatory markers and activity more than     Rosuvastatin (10mg) in spite of equal LDL-C reduction.   "
173576|NCT00115843|"     The purpose of this study is to demonstrate that the use of a continuous ambulatory     monitoring device will reduce both the time to effective rate control and the health care     expenditures associated with standard methods of rate control monitoring in patients     presenting with atrial fibrillation with a rapid heart rate.   "
173577|NCT00115856|"     This study aims to develop and refine the use of an intravascular wire to image plaque in the     aorta, iliac and femoral artery using MRI. This project aims to use this increased resolution     to identify the features within the plaque that is known to be associated with increased risk     of plaque and vessel occlusion.      The hypothesis is Intravascular MRI can detect and measure changes in response to therapy     over time in the critical features in plaques in peripheral arteries of patients with     atherosclerosis.   "
173578|NCT00115869|"     The Hutchinson Smoking Prevention Project is a 16-year, group-randomized trial to determine     the extent to which a school-based (grades 3-10), theory-based, social-influences tobacco use     prevention intervention can deter youth tobacco use throughout and beyond high school.   "
173579|NCT00115882|"     The primary goal of the Hutchinson Study of High School Smoking, a group-randomized trial     conducted by the Fred Hutchinson Cancer Research Center in partnership with 50 Washington     State high schools, is to develop and evaluate an innovative proactive smoking cessation     intervention, based upon Motivational Interviewing (MI) and Cognitive Behavioral Skills     Training (CBST), for its effectiveness in reaching teen smokers and helping them succeed in     quitting smoking. A positive finding would have significant implications for reducing youth     smoking and, ultimately, improving the nation's health.   "
173608|NCT00116259|"     There is a scarcity of clinical trials assessing the effects of medications in children with     bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel     anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder     comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group     trial. Patients were randomized to either aripiprazole or placebo.      The main hypotheses are:        1. Aripiprazole will significantly reduce maniac scores compared to placebo        2. Aripiprazole will significantly reduce ADHD scores compared to placebo   "
173609|NCT00116272|"     The purpose of the study is to evaluate the effect of etanercept when used in the first     trimester of pregnancy with respect to major structural birth defects of newborns. This is an     observational study only - no investigational product is used.   "
173580|NCT00115895|"     The thyroid cells take up iodine, and radioactive iodine is commonly used to irradiate     residual thyroid tissue and thyroid cancer following surgical removal of the thyroid gland     (thyroidectomy). A whole body radioactive iodine scanning is usually carried out after     thyroidectomy to assess the amount of thyroid tissue left behind at surgery (that might still     contain cancer), and to evaluate the presence of iodine avid lesions elsewhere in the body     (that might be cancer metastases). A large dose of radioactive iodine is often given, still     the optimal iodine dose to ablate the thyroid remnant after surgery is not known. In this     study, two radioactive iodine doses are compared in the ablation of the thyroid remnant, a     smaller (1110 MBq) dose and a larger (3700 MBq) dose. The study participants are randomly     allocated using a 1:1 ratio to receive either the smaller or the larger radioactive iodine     dose. These treatments are compared for safety, adverse effects, and the need for subsequent     repeat treatments. The individual absorbed radiation doses are measured. The study hypothesis     is that fewer repeat radioiodine treatments might be needed after the larger dose, but the     larger dose might be associated with a higher frequency of adverse events.   "
173581|NCT00115908|"     The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination     with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C     genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3     different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS,     PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.   "
173582|NCT00115921|"     The purpose of this study is to see if providing effective antimalarial treatment at home for     parents/guardians to treat their children for malaria will lead to an improved health outcome     compared to conventional healthcare.   "
173583|NCT00115934|"     This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS)     compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of     the MBTS to that of the RV-to-PA shunt on the incidence of death or cardiac transplantation     at 12 months post randomization; and compare the effect of the two shunts on intensive care     unit (ICU) morbidity, unintended cardiovascular interventional procedures, right ventricular     function, tricuspid valve regurgitation, pulmonary artery growth, and neurodevelopmental     outcome.   "
173584|NCT00115947|"     The purpose of this study is to investigate the effect of terlipressin on myocardial     perfusion and renal function.      Hypothesis: Significant improvement of renal function reflected by: glomerular filtration     rate (GFR), renal blood flow (RBF), excretion of salt and metabolites in the urine and     related hormones and peptides in the blood. No effect on the systolic function of the heart.   "
173585|NCT00115960|"     The purpose of this study is to determine the safety of and immune response to an     experimental HIV vaccine, HIV-1 gag DNA, with and without an IL-15 DNA adjuvant (at     escalating doses of 100, 500, and 1500 mcg). This study will also test the safety of and     immune response to the HIV-1 gag DNA vaccine plus IL-15 DNA adjuvant given with or without 2     other adjuvant-containing booster vaccines.   "
173586|NCT00115973|"     This trial is conducted in the United States of America (USA). This is an in-patient trial     investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week     out-patient maintenance period. A telephone contact visit is scheduled as a follow-up for the     final clinic visit. A subject's participation in this trial would be expected to be up to 16     weeks.   "
173587|NCT00115986|"     The purpose of this research study is to compare how the body reacts to different strengths     of the new H5N1 flu vaccine. The study will also look at how antibodies are made after a     subject receives the H5N1 flu vaccine. The vaccine will be given as a shot in the arm.     Participants will be randomly assigned to receive 1 of 4 different dosages of the vaccine or     a placebo (dummy) dose of the vaccine. Study procedures will include a physical exam, a urine     pregnancy test for women, and blood samples. Participants will be asked to complete a diary     to record temperatures, medications taken, and side effects from the vaccine. Volunteers will     be involved with study procedures for approximately 7 months. The study will enroll about     450-470 healthy participants, ages 18-64.   "
173588|NCT00115999|"     The purpose of this study is to directly compare the safety and efficacy of intra-thrombus     alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured     by a 30 day open vascular free surgery rate.   "
173654|NCT00106899|"     The purpose of this study is to examine how brain imaging technology can be used with other     tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's     disease (AD). This information will aid future clinical trials by providing a standard     assessment tool to measure the effects of treatments being studied.   "
173589|NCT00116012|"     The primary focus of this study is to explore the safety of a range of doses of rNAPc2 in     subjects who are managed in hospitals that most typically practice an early invasive strategy     (catheterization during the index admission). After completion of the ascending dose-ranging     part of the trial and review of these data by the Data and Safety Monitoring Board (DSMB),     the maximum tolerated dose of rNAPc2 will be studied in single-arm, open-label panels     (approximately 25 subjects each) of rNAPc2 with descending doses of unfractionated heparin     (UFH).   "
173590|NCT00116025|"     The main purpose of this study is to determine the half life of the hormone ghrelin in the     human body. Other purposes are to investigate the effect of ghrelin on appetite and     cardiovascular function.   "
173591|NCT00116038|"     The purpose of this study is to compare metal surface finishes (proximal-coated titanium     surface versus mid-coated titanium surface) on femoral components in hip arthroplasty.   "
173592|NCT00116051|"     The purpose of this study is to compare two surface materials (tantalum versus titanium fiber     mesh) of acetabular components in hip arthroplasty.   "
173593|NCT00116064|"     The purpose of this study is to evaluate intranasal lorazepam in paediatric status     epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common     paediatric medical emergency compared to our present first line therapy intramuscular     paraldehyde.   "
173610|NCT00116285|"     The purpose of this study is to evaluate the residual allergenicity of the modified ragweed     pollen in Ragweed MATA MPL (modified pollen allergen tyrosine adsorbate + Monophosphoryl     Lipid A) by skin prick testing. This is done by a comparison of the wheal response after skin     prick testing with different concentrations of aqueous native allergen, modified allergen,     modified tyrosine adsorbed allergen, and Ragweed MATA MPL.   "
173611|NCT00116298|"     The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T)     extended release (ER) versus conventional (immediate release [IR]) formulations, each in     combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed     Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.   "
173594|NCT00116077|"     This study seeks to increase the understanding of dopamine receptor function in the brain     during major depressive disorder and bipolar depression, as well as genetic changes that may     be behind changes in those receptors' actions. Dopamine is a natural messenger in the brain,     involved in reward, motivation, and mood.      Volunteers aged 18 to 55 who have primary major depressive disorder and those who have     bipolar depression (20 in each group), who are not HIV positive and do not have AIDS, and who     are not pregnant or breastfeeding may be eligible for this study.      A telephone interview will be held, for patients to answer standardized questions about     psychiatric or medical symptoms they may have experienced during their lifetime. Those     eligible for the study will undergo interviews and laboratory tests. A psychiatric interview     and clinical assessment will collect various data. Patients will undergo the following     procedures and tests:        -  A brief neurological examination        -  A one-minute electrocardiogram to measure electrical activity of the heart.        -  Laboratory tests measuring several substances in the blood and urine.        -  Pregnancy test.      A magnetic resonance imaging (MRI) scan will be done to create an image of the volunteer's     brain structure. The technique of MRI uses a strong magnetic field and radio waves to obtain     images of body organs and tissues. During the MRI scan, volunteers will lie still on a table     that will slide into the scanner for 30 minutes and in some cases up to but no more than 90     minutes. Volunteers will be asked to lie as still as possible during the procedure. Then a     PET system will create two images of brain blood flow-one of brain dopamine 1 receptor and     one of dopamine 2/3 receptor binding. Volunteers will be given a radiotracer, a tiny amount     of a drug that can be detected by a special camera in the PET scanner. A tiny flexible tube     will be placed in the vein of one arm during each PET scan but during the MRI scan.     Volunteers will be asked to lie still on the PET scanner table. A mask with large holes for     eyes, ears, and mouth will be placed over the head, to keep the head from moving. After     radiotracer injections are given, the PET scanner will create brain images. There may be two     PET scanning sessions, each requiring about 3 hours of scanning. During only one of these     there will be breaks. At the end of the scanning session, volunteers will be asked to drink     several glasses of water and urinate immediately, to reduce radiation exposure to the bladder     wall.      Genetic screening will help to enhance researchers' understanding of the role of dopamine     receptors in depression. A small blood sample, about 2 tablespoons, will be collected, to     isolate DNA from blood cells. Some of the blood samples or DNA may be stored for future     studies, but those samples will remain coded, so participants will not be identified. This     study will not have a direct benefit for participants. However, the results may provide     knowledge to help people in the future. This study does involve compensation.   "
173595|NCT00116090|"     This study will evaluate whether therapy that suppresses the immune system given to treat     inflammatory diseases of the eye is associated with a greater risk of death and of cancer.     Inflammatory diseases of the eye, including uveitis, scleritis, and mucous membrane     pemphigoid, are major blinding diseases. For some patients, treatment with corticosteroids is     not enough to control the diseases. Researchers expect to gain information about whether     immunosuppressive therapy is suitable for patients and which substances should be avoided.     Also, the study will evaluate the frequency of short-term complications with     immunosuppressive therapy as well as benefits that the therapy can bring to treatment of eye     diseases.      The medical charts of patients up to age 65 (median age range of 21 to 65) who have had an     inflammatory, noninfectious eye disease may be examined for this study. A database will be     constructed through a chart review of patients seen in the uveitis clinic of the National Eye     Institute since 1977 and three other sites. Patients who are considered exposed to     immunosuppressive therapies will be compared with two groups: the general U.S. population and     an internal group of patients with the same inflammatory eye diseases who did not receive     immunosuppression. Data regarding about 10,000 to 15,000 patients will be collected. Patients     will not be identified by the chart reviews. The incidence of cancer will be examined as well     as the outcomes of immosuppressive therapy as measured by control of the eye disease, visual     sharpness, changes in the use of corticosteroids, and rates of remission-when disease     symptoms are lessened.      Also examined will be medical charts of a control group of patients who did not receive     immunosuppressive therapy for their uveitis. Data on cancer incidence would be more difficult     to obtain, requiring personal contact with patients. In such situations, patients will be     contacted by phone or mail, and those providing informed consent will be asked about their     medical history, including previous occurrence of cancer and other conditions. For patients     who have died, the researchers will attempt to communicate with the next of kin regarding     this medical information.   "
173596|NCT00116103|"     The purpose of this study is to determine the safety and effectiveness of tacrolimus     inhalation aerosol in subjects with persistent asthma.   "
173597|NCT00116116|"     The purpose of this study is to evaluate whether a therapy with an all once daily regimen of     stavudine extended release (d4T XR), lamivudine (3TC), and efavirenz (EFV) leads to improved     outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.   "
173598|NCT00116129|"     This is a 24-week, randomized, double-blind, placebo-controlled, trial to evaluate the     safety, tolerability and efficacy of an orally administered growth hormone stimulating drug,     (code named MK-0677) in the treatment of female subjects with primary fibromyalgia. The basis     for this study is the observation that many fibromyalgia patients are growth hormone     deficient; an earlier study of injectable growth hormone had shown benefit in this population     of fibromyalgia patients.   "
173599|NCT00116142|"     This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to     one of the standard treatments (radiation and hormones) for men with high-risk prostate     cancer.   "
173600|NCT00116155|"     This is a multi-center, open-label, dose finding study of CV787 adenovirus in patients with     hormone refractory metastatic prostate cancer. Patients will receive treatment intravenously     at one of up to nine dose levels, each containing three to six patients.   "
173601|NCT00116168|"     A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses     of MEDI-528 in to healthy adult volunteers.   "
173602|NCT00116181|"     The investigator's laboratory is studying a skin disease known as psoriasis. The purpose of     this protocol is to study the action and the effects of Etanercept, on psoriasis. This     medication has been studied extensively and has been found to be effective and safe in the     treatment of psoriasis. The eligible patient will have 10% of his/her body surface area     involved with psoriasis vulgaris. This trial is a phase III study to help understand the     action of the drug etanercept, trade name Enbrel, for the adult patient with moderate to     severe plaque psoriasis and who is a candidate for internal medications.   "
173603|NCT00116194|"     The purpose of this study is to gather preliminary data that will determine the feasibility     of conducting a Phase III, randomized, controlled trial (RCT) that will provide definite     evidence in the use of physical exercise to prevent mobility disability in older persons.   "
173604|NCT00116207|"     The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects     the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN     may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.     Three medications will be tested for their effectiveness in DAN.   "
173605|NCT00116220|"     This clinical study was to determine if the use of 6 months of total androgen suppression     (hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer     would improve overall survival.   "
173606|NCT00116233|"     This trial will study REPEL-CV for reducing post operative adhesions following cardiovascular     (cv) surgery.   "
173607|NCT00116246|"     We propose to conduct a randomised-controlled study to investigate whether adopting     McRoberts’ position, after 45 minutes of active pushing with no signs of progress, can     increase the probability of vaginal delivery, preventing the need for forceps or vacuum     assistance. In our study we will allow 45 minutes of pushing before a further 45 minutes of     either the same, or our intervention (McRoberts’ manoeuvre).   "
173629|NCT00116532|"     The purpose of this study is to assess the efficacy of Escitalopram in the treatment of     obsessive compulsive disorder and to determine the optimal treatment dose.   "
173612|NCT00116311|"     The purpose of this study is to determine whether asthmatics have different adenosine     receptor expression profiles than healthy controls. We hypothesize that asthmatics will have     increased adenosine receptor expression versus control subjects.      We also want to study the effects of allergen inhalation on adenosine receptor expression in     asthmatics. We believe that adenosine receptor expression will be upregulated after allergen     inhalation.      Both hypotheses are being tested in sputum and peripheral blood.   "
173613|NCT00116324|"     The purpose of this study is to examine a specific variation in the genetic code for an     enzyme (LTC4 synthase) which plays an important role in the airway inflammation associated     with asthma. We hypothesize that asthmatic patients with this variant gene will have a better     response to montelukast than patients with the wild type gene, as measured by the ability of     montelukast to protect against a hypertonic saline challenge.   "
173614|NCT00116337|"     The purpose of this trial is to determine the efficacy of spinal cord stimulation to produce     an effective cough in patients with spinal cord injuries.   "
173615|NCT00116350|"     The purpose of this study is to test whether misoprostol is as effective as oxytocin for     treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two     circumstances: 1) where women have received prophylactic uterotonics in the third stage of     labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.   "
173616|NCT00116363|"     This is a research study to look at the ways in which a treatment called INGN241 can kill     melanoma cells or help the patient's immune system kill melanoma cells.   "
173617|NCT00116376|"     AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with     potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It     has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will     assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of     AEE788 in a recurrent GBM population.   "
173618|NCT00116389|"     The purpose of this study is to assess the 6-month survival rate and safety of talabostat and     gemcitabine in patients with stage IV adenocarcinoma of the pancreas.   "
173619|NCT00116402|"     The purpose of this study is to evaluate the blood and airway of subjects with mild to     moderate COPD while undergoing standard treatment.   "
173620|NCT00116415|"     The purpose of this study is to evaluate whether a therapy with an all once daily regimen of     efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) leads to improved outcomes, as     measured by viral load, CD4 counts, adherence, safety, and tolerability.   "
173621|NCT00116428|"     This trial compares the safety and effectiveness of catheter ablation for PAF with     antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR®     THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL®     catheter was FDA-approved for commercial distribution in the U.S. for treating patients with     Type I atrial flutter and drug refractory monomorphic ventricular tachycardia post myocardial     infarction. The catheter was approved for use in Europe for endocardial ablation for treating     cardiac arrhythmias.   "
173622|NCT00116441|"     The purpose of this study is to evaluate the safety and efficacy of vaccination with     autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor     (GM-CSF) producing cell line.   "
173623|NCT00116454|"     The recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high,     about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol     (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection     of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of     Lipiocis® in preventing recurrence after curative treatment of HCC in patients with viral or     alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation.   "
173624|NCT00116467|"     The purpose of this study is to evaluate clinical and laboratory safety associated with the     administration of GVAX leukemia vaccine and to determine the feasibility of generation of     GVAX leukemia vaccine in subjects with acute myelogenous leukemia (AML).   "
173669|NCT00107107|"     This is a multicenter, open-label extension study designed to examine the long-term safety of     pramlintide treatment in subjects with type 1 diabetes who have successfully completed     treatment in the parent study 137-150.   "
173625|NCT00116480|"     Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment     with conventional methods. Uncontrolled reports and three small randomised controlled trials     have suggested that misoprostol may have an additive effect to routine treatment, and there     is a serious danger that this method will be used widely without research to document the     effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose     to test whether 600 μg of sublingually administered misoprostol in women requiring additional     uterotonics after delivery, and after routine syntocinon to all women during or after     delivery, has additional effects above the additional conventional uterotonics in reducing     PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals     who give consent will be given locally routine treatment for PPH. In addition, they will be     enrolled by drawing the next of a series of randomised treatment packs containing misoprostol     or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls     after enrolment.   "
173626|NCT00116493|"     The purpose of this study is to test the efficacy of two enhanced regimens (deworming and     multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months     of age in Karachi, Pakistan.   "
173627|NCT00116506|"     Despite recent advances, most patients with advanced colorectal cancer continue to have a     poor prognosis. 5-FU, leucovorin, oxaliplatin and bevacizumab is a standard treatment option     for patients with stage IV colorectal cancer. Fluorouracil (5-FU), leucovorin and oxaliplatin     are considered traditional chemotherapies that try to stop tumor growth by affecting how they     divide. Bevacizumab is a therapy to try to block the blood vessels that tumors need to grow.     It is considered a 'targeted agent'. Erlotinib is another targeted agent, that has been shown     to be effective in treating lung and other cancers. This trial is assessing the potential     benefit of adding these second targeted agents to standard treatment.   "
173628|NCT00116519|"     The purposes of this study are to determine:        -  The safety of the study medication and any side effects that might be associated with          it;        -  Whether the study medication can help patients with low levels of 'good' cholesterol          (HDL-C) and high blood fats or triglycerides (TG);        -  How much of the study medication should be given to patients;        -  How the study medication compares to fenofibrate (Lofibra), a drug used for people with          low levels of HDL-C and high levels of TG.   "
173632|NCT00116571|"     The purpose of this study is to determine if transurethral photodynamic therapy with     lemuteporfin has a therapeutic effect on lower urinary tract symptoms due to an enlarged     prostate.      Photodynamic therapy (known as PDT) is a treatment that uses light to make a drug work.     This means the drug is light-activated. Light-activated drugs do not work until a certain     color of light shines on the drug. When the drug and the light combine, they react together     to destroy tissue.      This study is investigating PDT with lemuteporfin as a possible treatment for an enlarged     prostate. PDT with lemuteporfin may destroy overgrown prostate tissue and help urinary     symptoms go back to normal.   "
173633|NCT00116584|"     The purpose of this study is to assess whether children with moderate to severe bronchiolitis     treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven     nebulization will have improvements in measurements of airway more rapidly than those treated     with conventional air-oxygen driven nebulization.   "
173634|NCT00116597|"     The purpose of this study is to assess intranodal immunotherapy in locally advanced to     metastatic melanoma patients (American Joint Committee on Cancer [AJCC] stages IIb to IV).      For this, the investigators capitalize on their previous melanoma clinical trial (published     by Zajac P et al in Human Gene Ther 2003) and take advantage of a proprietary recombinant     vaccinia virus (replication inactivated) expressing 5 minigenes: 3 melanoma associated     antigens and 2 costimulatory molecules. Immunization with the recombinant vaccinia virus is     followed by 3 boosts with soluble, synthetic melanoma associated antigens.      The patients are immunized intranodally (groin lymph node) under ultrasonographic guidance in     an outpatient clinic. The protocol foresees 2 cycles of immunotherapy for alternate weeks and     lasts 15 weeks.   "
173635|NCT00116610|"     This is a Phase II research study that is designed for patients who have small cell lung     cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a     new platinum-based agent that is currently under investigation, in 21-day cycles.   "
173636|NCT00116623|"     The purpose of this study is to investigate the efficacy of Indomethacin compared to     Magnesium Sulfate (MgSO4) in reducing neonatal morbidity through a prospective double blind     randomized clinical trial. The specific aim of the project is to test the hypothesis that     Indomethacin, compared to MgSO4, will decrease the proportion of neonates diagnosed with     major complications or death.   "
173637|NCT00116636|"     Expected Enrollment: 40 patients      Study Start Date: June 2005      Study Objectives:        -  To conduct a pilot study to assess the safety, tolerability, and antiviral activity of          Kaletra 400/100 mg taken twice a day (bid) in antiretroviral (ARV)-naïve HIV-infected          patients at Week 48      Primary Objectives:        -  To determine the proportion of patients with HIV RNA <400 copies/mL at weeks 24 and 48        -  To determine the proportion of patients with HIV RNA < 50 at weeks 24 and 48        -  To elucidate the specific adverse event (AE) profile of Kaletra single agent therapy      Secondary Objectives:        -  To assess the proportion of patients below the limit of quantification (LOQ) at each          visit. Patients will be observed at baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36,          40, 44 and 48.        -  To determine the time to HIV RNA reaching <400 and <50 copies/mL        -  To determine the time to virologic failure        -  To assess change from baseline at each visit for HIV RNA and CD4 count at weeks 4, 8,          12, 24 and 48.        -  To assess changes in genotype from baseline to time of confirmed virologic failure (2          consecutive HIV RNA measurements >400 copies/mL after suppressing to <400 copies/mL) or          at time of treatment intensification.        -  To characterize changes in lipid and triglyceride concentrations over time and the          effect of treatment with appropriate drugs (fibrate or statin, if necessary) on these          elevations.        -  To evaluate the safety and tolerability of subjects through 48 weeks of drug exposure.        -  To describe virologic response following intensification in Kaletra single agent          virologic failures   "
173696|NCT00107536|"     Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. This phase II trial is studying how well lapatinib ditosylate works     in treating patients with unresectable liver or biliary tract cancer   "
173638|NCT00116649|"     Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the     sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this     study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment     of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso,     and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The     secondary objective is to evaluate the effectiveness of treatment with imiquimod in people     with large surface areas of AK.   "
173639|NCT00116662|"     The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of     three different strengths of resiquimod gel applied to common wart(s) three times a week for     up to twelve weeks.      A second purpose is to evaluate the safety of the drug.   "
173640|NCT00116675|"     The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of     three different strengths of resiquimod gel applied to common wart(s) three times a week for     four weeks.      A second purpose is to evaluate the safety of the drug.   "
173641|NCT00116688|"     The purpose of this study is to determine the safety of romiplostim as a long-term treatment     in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to     romiplostim, and to evaluate changes in patient reported outcomes due to the use of     romiplostim. Participants must have previously completed a romiplostim ITP study.   "
173642|NCT00116701|"     Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb)     ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV     darbepoetin alfa results in a mean Hb > 11 g/dL.      Treatment Period 2:To demonstrate that switching subjects with a Hb > 11 g/dL and ≤ 13 g/dL     from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at >     11 g/dL.   "
173643|NCT00116714|"     The Rheumatoid Arthritis DMARD Intervention and Utilization Study (RADIUS 1) is designed to     systematically collect and document use patterns, effectiveness, and safety of DMARD     treatments currently used in the management of rheumatoid arthritis (RA). It is anticipated     that study data may help improve the quality of information upon which clinical decisions are     based.   "
173644|NCT00116727|"     To systematically collect and document use patterns, effectiveness and safety of DMARD     treatments currently used in the management of rheumatoid arthritis. The primary purpose of     this study is to estimate the incidence of serious adverse experiences and adverse     experiences of interest in patients with rheumatoid arthritis (RA) treated with ENBREL®.   "
173645|NCT00116740|"     This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c     receptor agonist, in clinical development as a potential treatment for obesity.      The purpose of this study is to obtain a preliminary assessment of the safety and efficacy of     APD356, when administered daily for 12 weeks, in obese subjects who are otherwise healthy.     Subjects who are on concomitant medications for control of hypertension or blood lipids may     qualify.   "
173646|NCT00116753|"     The rationale of the study was to evaluate different degarelix dosing regimens for a     three-month interval that was to produce and maintain castration in prostate cancer patients     through immediate and prolonged testosterone suppression, and to provide confirmatory     evidence of the safety of degarelix.   "
173647|NCT00106795|"     This study will examine abnormalities in mitochondria (energy-producing machinery of cells)     and in genes related to mitochondria in the blood cells, muscle, and fat of HIV-positive     patients who are taking nucleoside reverse transcriptase inhibitors (NRTIs) and in patients     not currently taking HIV medications, and compare the results to healthy volunteers. Many     patients with HIV infection take NRTIs to help control the infection. These medications may     damage cell mitochondria, possibly causing side effects such as fatigue. This study will     explore the relationship between changes in mitochondria and related genes and patient     reports of energy level, mood and quality of life.      Healthy volunteers and HIV-infected patients between 18 and 55 years of age may be eligible     for this study. Healthy volunteers must test negative for the HIV antibody. HIV-positive     patients must have been diagnosed positive for at least 1 year. Patients who are taking     antiretroviral therapy must have been taking the same drug regimen (with at least two NTRIs     and no protease inhibitors) for at least 3 months. HIV positive patients not taking     antiretroviral medication must not have had antiretroviral therapy for at least 1 year.     Candidates are screened with a medical history, brief physical examination, blood and urine     tests, and questionnaires related to mood and energy.      Qualified volunteers will undergo the following procedures during three or four study visits:      Visit 1      Complete history and physical examination, blood tests, and questionnaires about energy     level, mood, and quality of life.      Visit 2      Muscle and fat biopsy: Before the biopsy, blood is drawn to check blood counts and to test     for pregnancy in women who can become pregnant. The biopsy is done on an outpatient basis in     the operating room. The site of the biopsy (an area on the upper arm or upper leg) is numbed     with an injection under the skin. A 1-inch incision is made over the muscle to be biopsied     and a small sample of muscle tissue and small sample of fat are removed. The incision is then     closed and bandaged. Following the biopsy, you will be monitored for about 4 hours in the     clinic. Strenuous physical activity should be restricted in the week following biopsy to     allow healing.      Visit 3      Examination of biopsy site and possible apheresis: The biopsy site is examined for healing.     Apheresis may be scheduled for this visit or for an extra visit between the biopsy and the     final visit. This procedure for obtaining white blood cells for study is optional. For     apheresis, blood is withdrawn from a needle placed in a vein in the arm and the white cells     are separated from the rest of the blood. The white cells are extracted and the red cells and     plasma are then returned to the body through a second needle.   "
173648|NCT00106808|"     The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2     Diabetes. Both the safety and blood sugar lowering effects of these treatments will be     studied.   "
173649|NCT00106821|"     The purpose of this study is to look at the benefits of tiotropium, an approved drug for the     treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), in a     population of patients with COPD who are of African American descent.   "
173650|NCT00106834|"     The purpose of this study is to determine if infliximab (anti-TNF) is effective in the     treatment of plaque psoriasis.   "
173651|NCT00106847|"     The purpose of the study is to evaluate the safety and effectiveness of scheduled and as     needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific     proteins in the body's immune system to help control the development of inflammation to help     reduce painful disease.   "
173652|NCT00106860|"     The purpose of the study is to assess the safety and effectiveness of the experimental drug,     a benzodiazepine drug, in long-term use and the effects on quality of life, social and     occupational functioning, sleep, and daytime sedation in subjects with anxiety disorder.   "
173653|NCT00106886|"     The purpose of the HOPE-2 study is to determine whether long term supplementation with folic     acid, vitamins B6 and B12 aimed at homocyst(e)ine reduction reduces the rates of major fatal     and nonfatal cardiovascular events in patients with established cardiovascular disease and/or     diabetes mellitus.   "
173697|NCT00107549|"     The purpose of this study is to determine the safety of two recombinant HIV vaccines in HIV     infected young adults on stable anti-HIV therapy.   "
173655|NCT00106912|"     This study will collect data needed to design a treatment trial for patients with Fabry     disease using the experimental drug AT-1001. Fabry disease is an inherited metabolic disorder     in which an enzyme called alpha-galactosidase A, which normally breaks down fatty substances     called glycolipids, is missing or does not function properly. As a result, glycolipids     accumulate in various tissues, causing liver, kidney, nerves, skin, muscle and blood vessel     problems. No treatment is given in this survey study.      Males 18 years of age and older with Fabry disease who have certain genetic mutations     associated with enhancement of alpha-galactosidase A activity may be eligible for this study.     Participants undergo the following tests and procedures over 5 days:      Day 1      Medical history and physical examination, blood tests, electrocardiogram (EKG), routine     urinalysis, measurements of height, weight, and vital signs (blood pressure, heart rate,     breathing rate, and temperature).      Day 2      Blood tests, 24-hour urine collection, vital signs and sweat test. The sweat test (also     called QSART, or quantitative sudomotor axon reflex test) measures the amount of sweat in a     particular area of skin. A small amount of medication called acetylcholine is put on an area     of the skin and a small electric current is applied to stimulate the sweat glands.      Day 3      Blood tests, 24-hour urine collection, vital signs, and skin biopsy. For the skin biopsy, a     small area of skin is numbed and a punch device is used to remove a 3-mm (1/8-inch) layer of     skin for microscopic examination.      Day 4      Blood tests, 24-hour urine collection, vital signs, and QSART.      Day 5      Blood tests and vital signs.      In addition to the above, patients are scheduled at some point in the 5-day study for an eye     examination, brain magnetic resonance angiogram (MRA), and a heart examination and     echocardiogram. MRA uses a strong magnetic field and radio waves to provide images of the     blood vessels in the head and neck. It can detect abnormalities such as aneurysms, vessel     malformations, and thickening of the vessel walls. An echocardiogram is an ultrasound test     that shows how well the heart pumps blood and if there is thickening of the heart muscle.      Patients who are taking enzyme replacement therapy discontinue treatment for up to 6 weeks     (no more than two missed infusions) to allow accurate measurement of the amount of     alpha-galactosidase A the patient's body produces by itself. They provide weekly blood     samples between the time they stop treatment and enter the study. The samples are used to     monitor the removal of the enzyme from the body and the possible buildup of Gb(3) in the     blood.   "
173656|NCT00106925|"     This study will provide follow-up evaluation and care of patients who have undergone     allogeneic (donor) stem cell transplantation at the NIH Clinical Center. Patients are     monitored for their response to treatment, disease relapse, and later-occurring effects of     the transplant.      Patients between 10 and 80 years of age who received a donor stem cell transplant at the NIH     Clinical Center under an NHLBI protocol may be eligible for this study. Candidates must have     had their first transplant at least 3 years before entering the current study.      Participants are generally seen in the clinic every 12 months for some or all of the     following procedures:        -  Periodic physical examinations, eye examinations, and blood and urine tests.        -  Bone marrow aspiration and biopsy: A sample of bone marrow is obtained for microscopic          examination. The patient is given local anesthesia or conscious sedation. An area of the          hipbone is numbed, a thin needle is inserted through the skin into the bone, and a small          amount of marrow is withdrawn.        -  Tissue biopsy: A small piece of tissue or tumor is obtained for microscopic examination.          Depending on the site of the biopsy, the tissue may be removed using a cookie          cutter-like punch instrument, a needle, or a knife. The area is numbed and the tissue          is removed with the appropriate tool.        -  Imaging tests to visualize organs, tissues, and cellular activity in specific tissues.          For these tests, the patient lies on a table that slides into the scanner. They may          include the following:             1. Nuclear scans use a sensitive camera to track a small amount of radioactive               material (radioisotope) that is given to the patient by mouth or through a vein.               The scan may show abnormal areas of tissue in the bones, liver, spleen, kidney,               brain, thyroid, or spine.             2. Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to examine               small sections of body organs and tissues.             3. Computerized tomography (CT) uses x-rays and can be done from different angles to               provide a 3-dimensional view of tissues and organs.             4. Positron emission tomography (PET) uses a fluid with a radioisotope attached to it               to show cellular activity in specific tissues. The fluid is given through a vein               and travels to the cells that are most active (like cancer cells), showing if there               is an actively growing tumor.        -  Pulmonary (lung) function tests: The patient breathes into a machine that measures the          volume of air the person can move into and out of the lungs.        -  Heart function tests may include the following:             1. Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes               placed on the chest transmit information from the heart to a machine.             2. Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an               image of the heart and examine the function of the heart chambers and valves.             3. Multiple gated acquisition scan (MUGA) is a nuclear medicine test that uses a small               amount of radioactive chemical injected into a vein. A special scanner creates an               image of the heart for examining the beating motion of the muscle.      Disease relapse or progression, or transplant-related problems may be treated with standard     medical, radiation, or surgical therapy, or patients may be offered experimental therapy.   "
173657|NCT00106938|"     The study is being conducted to demonstrate the non-inferiority of carotid artery stenting     (CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to     carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid     atherosclerotic disease.   "
173658|NCT00106951|"     To investigate the role of racial and socioeconomic disparities in coronary heart disease     (CHD) mortality in the United States.   "
173659|NCT00106964|"     Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by     vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate     protection against this virus. In an attempt to improve response to vaccination and achieve     protection from hepatitis B, this trial will compare the immune system response to 3     hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age.   "
173660|NCT00106977|"     This study will explore the range and type of medical and developmental problems in patients     with Muenke syndrome, a condition that results when one or more of the suture between the     bones of the skull close before birth. Because of the premature closure, the skull is not     able to grow in its natural shape; instead, it compensates with growth in areas of the skull     where the sutures have not yet closed. This can result in an abnormally shaped head, wide-set     eyes, and flattened cheekbones. Patients may also have an enlarged head, abnormalities of the     hands or feet, and hearing loss.      The fibroblast growth factor receptor 3 (FGFR3) gene, which is involved in the development     and maintenance of bone tissue, plays a role in Muenke syndrome. In some cases, the FGFR3     mutation is inherited from a parent with Muenke syndrome; in other cases, where there is no     family history of the disorder, the mutation occurs anew. A better understanding of this gene     may lead researchers to develop better treatments and genetic counseling for people affected     by Muenke syndrome.      Patients with Muenke syndrome and their blood relatives may be eligible for this study.     Family members with confirmed Muenke syndrome will have genetic counseling, and patients     undergo the following tests and procedures:        -  Review of medical records and test results.        -  Questionnaires about the patient's prenatal, birth, newborn, and past medical history;          family history; growth and development; medications; and current therapies.        -  Physical, neurological, ear, nose and throat, dental, and eye examinations.        -  Neuropsychological testing to assess cognitive thinking abilities.        -  Hearing evaluation. This includes an audiology test in which the patients listens to          soft tones through earphones; a power reflectance test in which a chirping sound is          heard through an earpiece placed at the entrance to the ear canal, and possibly an          ABR/ASSR test, in which electrodes are attached to the forehead, earlobes, and behind          the ears to measure brain waves in response to certain conditions.        -  MRI scan of the brain. MRI uses a strong magnetic field and radio waves to produce          detailed pictures of the brain. During the scan, the patient lies on a table in a narrow          cylinder (the scanner), wearing ear plugs to muffle loud noises that occur with          electrical switching of the magnetic fields.        -  MRI scan of the middle and inner ear. This test is similar to the MRI, but uses a dye          injected in a vein to enhance the images.        -  CT scan of the skull. CT uses x-rays to produce 3-dimensional images of the part of the          body studied.        -  Dental evaluation with x-rays.        -  Skeletal survey (x-rays of all bones of the body).        -  Developmental assessment of IQ testing.        -  Blood tests for research purposes. A cell line may be established for use in future          research.        -  Medical photographs to demonstrate clinical features, including side and front views of          the face, head, and other parts of the body that may be involved in Muenke syndrome,          like the hands and feet.        -  Other consultations or tests as clinically indicated   "
173661|NCT00107003|"     This study will examine whether an experimental drug called GW572016 can delay tumor growth     in patients with glioblastoma multiforme (GMB, a malignant brain tumor). GW572016 is believed     to affect cancer cell function by interfering with the internal signaling needed for the     cancer to grow. The study will also determine whether the presence of specific proteins in     the tumor can predict what effects GW572016 will have on the tumor.      Patients 18 years of age and older with GMB whose brain tumor does not respond to standard     medical treatment and who can undergo surgery for their tumor may be eligible for this study.     Candidates are screened with a physical examination and neurocognitive examination, blood     tests, electrocardiogram (EKG), echocardiogram (ultrasound test of heart function) or MUGA     scan (nuclear medicine test of heart function), magnetic resonance imaging (MRI) of the head,     and computed tomography (CT) of the head. CT uses x-rays and MRI uses a magnetic field and     radio waves to show brain structure.      Participants undergo the following tests and procedures:        -  MRI and blood tests before surgery.        -  Surgery to remove the brain tumor.        -  Follow-up MRIs every 8 weeks after surgery.        -  Follow-up echocardiograms or MUGA scans every 8 weeks after surgery.        -  GW572016 treatment starting 7-10 days before surgery and continuing until the patient or          doctor decides it is in the patient's best interest to stop it or until the tumor          worsens. (The drug is stopped temporarily for surgery and a healing period after          surgery.)        -  Blood tests every 2 weeks to evaluate the effects of GW572016 on the body.        -  Blood test before the first GW572016 treatment and at the time of surgery to assess the          effect of the drug on the cells and to determine how much drug is present in the blood          at the time of surgery.      Participants are followed in clinic at least monthly while taking GW572016. While on     treatment they keep a diary documenting their daily treatments. The diary is collected at the     monthly follow-up exams. After the treatment ends, patients are contacted periodically by the     research staff for the rest of their lives to follow the long-term effects of the study.   "
173662|NCT00107016|"     The purpose of this study is to examine the effect of the combination of everolimus and     letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly     diagnosed estrogen receptor positive breast cancer.   "
173663|NCT00107029|"     This protocol is a study of HIV+ young people who were identified as having certain HIV-1     specific T-cell responses and genetic markers while previously enrolled in the 5-year     longitudinal adolescent study, REACH. Blood samples will be collected, a medical and     medication history and physical examination will be performed every 6 months for a total of 2     years.   "
173664|NCT00107042|"     This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a     two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate     immunogenicity of the products in this population, barriers to vaccine delivery, and factors     which predict a diminished immune response. Since these youths are also potential candidates     for future HIV vaccine trials, this study will also include preliminary assessment of youths'     understanding of informed consent forms, and willingness to participate in a vaccine trial     and return for multiple visits (including blood draws for immunologic assessment).   "
173665|NCT00107055|"     The purpose of this study is to gain initial safety and efficacy data on the experimental     agent REN-1654 in patients with pain that radiates down the leg(s), and is typical of     sciatica (lumbosacral radiculopathy). These patients will usually have a herniated disc that     is causing compression on the nerves coming out of the spinal column.   "
173666|NCT00107068|"     This study will investigate the efficacy of aerobic exercise and progressive resistance     training (PRT), singularly and combined, on changes in walking endurance for     mildly-to-moderately affected chronic stroke patients. Specifically, we will determine the     relative importance of training induced changes in muscle strength versus aerobic fitness on     increases in gait velocity and 6-min walking distance, and assess the concomitant functional     and psychosocial impact of increased muscle strength, aerobic fitness and improved gait. This     longitudinal study will be conducted as a double blinded factorial randomized controlled     trial of exercise training for chronic stroke patients.   "
173667|NCT00107081|"     The purpose of this study is to determine whether, in children with cancer presenting with     fever in severe chemotherapy-induced neutropenia at low risk for medical complications, oral     antibiotics in an outpatient setting after an initial phase of intravenous antibiotics and     in-hospital observation for 8 to 22 hours, is not inferior as to safety and efficacy compared     to continued intravenous antibiotics given in-hospital.   "
173668|NCT00107094|"     In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide     followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage     breast cancer.   "
173670|NCT00107120|"     Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the     S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake     inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to     provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment     of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be     eligible to enter an open-label extension study.   "
173671|NCT00107159|"     RATIONALE: Vaccines made from a person's white blood cells and a donor's tumor cells may help     the body build an effective immune response to kill tumor cells.      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients     with unresected stage III or stage IV melanoma.   "
173672|NCT00107172|"     This randomized phase III trial studies surgery and internal radiation therapy to see how     well they work compared to surgery alone in treating patients with stage I non-small cell     lung cancer. Surgery may be an effective treatment for non-small cell lung cancer. Internal     radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.     It is not yet known whether surgery and internal radiation therapy are more effective than     surgery alone in treating non-small cell lung cancer.   "
173673|NCT00107185|"     RATIONALE: Vaccines made from a person's white blood cells and tumor cells may help the body     build an effective immune response to kill tumor cells. Giving vaccine therapy after surgery     may be a more effective treatment for malignant glioma.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating young patients who are undergoing surgery for malignant glioma.   "
173674|NCT00107198|"     This clinical trial is studying how well surgery and/or combination chemotherapy with or     without radiation therapy or observation only work in treating young patients with newly     diagnosed stage I or stage II lymphocyte predominant Hodgkin disease (LPHD). Surgery may be     an effective treatment for LPHD. Drugs used in chemotherapy, such as doxorubicin,     vincristine, prednisone, and cyclophosphamide, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Radiation     therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination     chemotherapy) with or without radiation therapy may kill more cancer cells.   "
173675|NCT00107211|"     RATIONALE: Vaccines made from peptides and a person's white blood cells may help the body     build an effective immune response to kill tumor cells. Injecting the vaccine directly into a     lymph node may cause a stronger immune response and kill more tumor cells. Giving vaccine     therapy before surgery may be effective treatment for ductal carcinoma in situ of the breast.      PURPOSE: This phase I trial is studying the side effects and best way to give vaccine therapy     in treating patients who are undergoing surgery for ductal carcinoma in situ of the breast.   "
173676|NCT00107237|"     RATIONALE: AEE788 and everolimus may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving AEE788     together with everolimus may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of AEE788 when     given together with everolimus and to see how well they work in treating patients with     recurrent or relapsed glioblastoma multiforme.   "
173677|NCT00107250|"     RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as     paclitaxel, carboplatin, or capecitabine, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving AZD2171 together     with chemotherapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of AZD2171 when given     together with chemotherapy in treating patients with advanced non-small cell lung cancer     (closed to enrollment as of 8/9/07), colorectal cancer, or other cancer suitable to     capecitabine treatment.   "
173678|NCT00107263|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by lowering the amount of estrogen the body makes.     Zoledronate may prevent bone loss in patients who are receiving letrozole. It is not yet     known which schedule of zoledronate is more effective in preventing bone loss in patients     with breast cancer.      PURPOSE: This randomized phase III trial is studying two different schedules of zoledronate     to compare how well they work in preventing bone loss in postmenopausal women who are     receiving letrozole for stage I, stage II, or stage IIIA breast cancer.   "
173679|NCT00107276|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one chemotherapy drug may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with     capecitabine works in treating women with stage IV breast cancer.   "
173680|NCT00107289|"     The purpose of this research study is to find how active and safe 131 I-MIBG is in patients     with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.   "
173681|NCT00107315|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as capecitabine, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving bevacizumab together with     capecitabine may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with     capecitabine works as first-line therapy in treating older patients with metastatic     colorectal cancer.   "
173682|NCT00107341|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving bortezomib together with paclitaxel and carboplatin may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with paclitaxel     and carboplatin works in treating patients with unresectable, metastatic cancer of the     esophagus or gastroesophageal junction.   "
173683|NCT00107354|"     RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the     immune system in different ways and stop cancer cells from growing.      PURPOSE: This phase I trial is studying the side effects of cellular adoptive immunotherapy     in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or     myelodysplastic syndromes that relapsed after donor stem cell transplant.   "
173684|NCT00107367|"     RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a     tumor was surgically removed may kill any remaining tumor cells and cause less damage to     normal tissue.      PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in     treating patients who are undergoing surgery to remove a metastatic brain tumor.   "
173685|NCT00107380|"     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find     cancer cells and carry cancer-killing substances to them without harming normal cells.     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as     cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Giving a radiolabeled monoclonal antibody together with rituximab and combination     chemotherapy may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving iodine I 131 tositumomab together     with rituximab and combination chemotherapy works in treating older patients with stage II,     stage III, or stage IV B-cell non-Hodgkin's lymphoma.   "
173686|NCT00107393|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     capecitabine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving trastuzumab together with capecitabine may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving trastuzumab together with     capecitabine works in treating women with metastatic breast cancer.   "
180259|NCT00203567|"     To study the efficacy and safety of beaded extended-release Carbamazepine (Equetro) in the     treatment of patients with Bipolar Disorder with a Major Depressive Episode.   "
173687|NCT00107419|"     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating     patients with recurrent and unresectable or metastatic chondrosarcoma.   "
173688|NCT00107432|"     This phase II trial is studying how well sorafenib works in treating patients with malignant     mesothelioma. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.   "
173689|NCT00107445|"     This phase II trial is studying how well EF5 works in finding oxygen in tumor cells of     patients who are undergoing surgery or biopsy for cervical, endometrial, or ovarian     epithelial cancer. Diagnostic procedures using the drug EF5 to find oxygen in tumor cells may     help in planning cancer treatment   "
173690|NCT00107458|"     RATIONALE: Drugs used in chemotherapy, such as valproic acid, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Valproic acid may also stop the growth of solid tumors or CNS tumors by blocking blood flow     to the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of valproic acid in     treating patients with recurrent or refractory solid tumors or CNS tumors.   "
173691|NCT00107471|"     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in     bone marrow or peripheral blood and may help the immune system recover from the side effects     of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Topotecan may     make tumor cells more sensitive to radiation therapy . Giving topotecan and G-CSF together     with radiation therapy may be an effective treatment for brain stem glioma.      PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when     given together with G-CSF and radiation therapy and to see how well they work in treating     young patients with newly diagnosed brain stem glioma.   "
173692|NCT00107484|"     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) using     ferumoxtran-10, may help find and diagnose breast cancer that may have spread to the axillary     lymph nodes and may help in planning breast cancer treatment.      PURPOSE: This phase II trial is studying how well MRI using ferumoxtran-10 works in finding     metastases to the axillary lymph nodes in patients with invasive breast cancer.   "
173693|NCT00107497|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy in different ways and giving it after surgery may kill any tumor cells that remain     after surgery.      PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it     works in treating women with localized breast cancer.   "
173694|NCT00107510|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of     immune cells found in bone marrow or peripheral blood and may help the immune system recover     from the side effects of chemotherapy. Giving docetaxel and carboplatin together with     pegfilgrastim before surgery may shrink the tumor so that it can be removed.      PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together     with pegfilgrastim works in treating patients who are undergoing surgery for stage II or     stage III breast cancer.   "
173695|NCT00107523|"     RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Pravastatin may help idarubicin and cytarabine work better by making cancer cells     more sensitive to the drugs. Giving pravastatin together with idarubicin and cytarabine may     kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of pravastatin when     given together with idarubicin and cytarabine in treating patients with acute myeloid     leukemia.   "
173698|NCT00107562|"     Social networks are thought to hold the potential for shaping behavior on the grounds that     social and situational factors more strongly influence behavior than do personality     variables. This is a behavioral intervention study that will test a 6-session, small-group,     peer-network intervention among adolescent males and females and their friends. The     intervention primarily focuses on reducing risky sexual behavior and increasing condom use     among adolescent males and females, aged 16-19. The concurrent use of alcohol and marijuana     during sex is also a focus as these two substances are widely used among adolescents and fuel     risky sexual behavior.   "
173699|NCT00107575|"     To test the effectiveness of an smoking cessation treatment for smokers who also drink     alcohol heavily.   "
173700|NCT00107588|"     The goal of this research is to improve treatment outcome for marijuana-dependent     individuals. The current study builds on the findings of our prior NIDA-funded marijuana     treatment study in which improved client outcomes were associated with greater treatment     attendance, greater client self-efficacy, and greater use of coping skills. We will use a     contingency management paradigm to provide tangible reinforcement for completing homework     assignments that are designed to enhance coping skills. It is anticipated that this will     result in greater homework compliance, leading to greater self-efficacy regarding one's     ability to cope with high-risk situations. Improved self-efficacy will enhance the likelihood     of employing coping skills in high-risk situations, thereby increasing the probability of     achieving and maintaining abstinence.   "
173754|NCT00108290|"     In men with prostate cancer who do not have evidence of spread to bone or other sites on     computed axial tomography (CAT) scan/bone scan but are still at significant risk of failing     treatment with surgery or radiation alone, a combination of chemotherapy and hormone therapy     is being given for 6 months followed by surgery to remove the prostate.   "
180293|NCT00204022|"     The purpose of the study is to determine whether mycophenolate mofetil is superior to     azathioprine to prevent flares of lupus nephritis.   "
173701|NCT00107601|"     Glucontrol is a prospective, randomized, controlled, multi-centric study. The present study     will compare the effects of two regimens of insulin therapy, respectively titrated to achieve     a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between     7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively).      This project aims at defining whether a tight glucose control by insulin improves the vital     outcome in a mixed population of critically ill patients (around 3000 patients).      Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays     in the Intensive Care Unit (ICU) and in the hospital, length of ICU stay without life-support     therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ     failures, and number of red-cell transfusions.   "
173702|NCT00107614|"     The purpose of this study is to find out what the response is and the side effects are with     chemotherapy using a combination of drugs called D.T. PACE (Dexamethasone, Thalidomide,     cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide) + Rituxan, followed by two     autologous transplants.   "
173703|NCT00107627|"     The Skin Incision Study evaluates the efficacy of skin closure methods: skin staples and     subcuticular sutures at 6 weeks and at 3 months following the operation by measuring cosmesis     and pain.   "
173704|NCT00107640|"     Older adults become more sensitive to alcohol, and alcohol also interacts adversely with     their common medical conditions and medications. The aim of Project SHARE (Senior Health and     Alcohol Risk Education) is to see whether patient and provider education can decrease risky     alcohol use and reduce health care costs in persons 60 years of age and older.   "
173705|NCT00107653|"     This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc     weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus     non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on     study treatment is 3-12 months and the target sample size is 500+ patients.   "
173706|NCT00107666|"     Over 500,000 patients undergo cardiac surgery with CPB in the United States annually.     Although mortality rates have decreased with advances in perioperative care, many patients     are affected by postoperative organ dysfunction. The incidence of complications may exceed     30%. It has been speculated that an exaggerated inflammatory response to surgical trauma and     the CPB machine are likely causes for this morbidity. Factors predisposing organ dysfunction     include tissue injury, endotoxemia, and oxidative stress. High risk patients can be     identified preoperatively through the validated Parsonnet Additive Risk Score. CTI-01 has     demonstrated potent anti-inflammatory and tissue protection activity in multiple animal     models of disease including pancreatitis, ischemia-reperfusion injury, sepsis, renal injury,     and endotoxemia. These findings support its clinical use in critical care medicine including     cardiac surgery. Patients will receive a total of six doses, administered intravenously just     prior to and after surgery.   "
173707|NCT00107679|"     The purpose of this study is to compare the development of abnormal cell growth or cancer in     the anal region of individuals who are receiving one of two different anti-HIV treatment     strategies.   "
173708|NCT00107692|"     The purpose of this study, and its original contribution to research, is to determine the     impact of a physical activity skill development and parent centered family weight management     program on the weight, cardiovascular health, physical activity, dietary intake and sedentary     behaviors of overweight and obese children.   "
173709|NCT00107705|"     The purpose of this study is to evaluate the residual allergenicity of Tree MATA (modified     pollen allergen tyrosine adsorbate) by skin prick testing. This is done by a comparison of     the wheal response after skin prick testing with aqueous native and modified allergen,     modified tyrosine adsorbed allergen and Tree MATA MPL (modified tyrosine adsorbed + MPL     [Monophosphoryl Lipid A]).   "
173710|NCT00107718|"     This Phase II study is designed to evaluate the anti-tumor activity of three dose groups of     SB-485232 (0.01, 0.1, and 1.0 mg/kg/day) administered intravenously as a single agent in     subjects with previously untreated metastatic melanoma.   "
173711|NCT00107731|"     The purpose of this study is to determine whether quetiapine when used as adjunct to lithium     or divalproex is safe and effective in the maintenance treatment of adult patients with     Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment     Phase and the Randomized treatment Phase.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
173731|NCT00107991|"     This study is being done to test a drug called etanercept (Enbrel®). Etanercept has been     approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic moderate     to severe plaque psoriasis (PsO), for use in reducing the signs and symptoms of moderately to     severely active rheumatoid arthritis (RA) in adults and children, and psoriatic arthritis     (PsA) and ankylosing spondylitis (AS) in adults. It is available by prescription for the     treatment of PsO, RA, PsA, and AS. Etanercept is approved for injection under the skin at a     dose of 50 mg per week in patients with psoriasis.      The purpose of this study is to determine whether etanercept is safe and effective for the     treatment of hidradenitis. Another purpose of this study is to determine the impact of     etanercept treatment of hidradenitis on skin related to quality of life.      The skin lesions typically associated with hidradenitis are thought to be partly due to a     blockage that occurs in sweat glands, called apocrine ducts, which become inflamed and     eventually destroyed. A protein found in the body called tumor necrosis factor alpha, or TNF-     α, is a hormone that causes this inflammation or swelling. The study drug, etanercept, blocks     the action of TNF- α. By blocking the action of TNF-α, etanercept may provide a reduction in     the signs and symptoms of hidradenitis.      This study will take place at the University of Pennsylvania and will involve up to 21     participants ages 18 and up. Approximately 21 subjects will participate at the University of     Pennsylvania.      Each patient will participate in this study for a maximum of 6 months. The study consists of     a screening visit, baseline assessment visit (Day 1), a treatment period (Week 2 - Week 14),     and a one month follow-up visit (Week 18 visit). The total duration of the study will be     approximately 2 years.   "
173732|NCT00108004|"     This open-label, multicenter study is designed to investigate the clinical utility and safety     of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to     achieve the desired level of glycemic control using insulin therapy.   "
173715|NCT00107783|"     This 3-year study will examine the safety and effectiveness of long-term use of nitisinone     (Orfadin) for treating joint problems in patients with alkaptonuria, an inherited disease in     which a compound called homogentisic acid accumulates. The excess homogentisic acid causes     arthritis and limited joint movement. It can also cause heart valve damage and kidney stones.      Patients between 30 and 80 years of age with alkaptonuria may be eligible for this study.     Patients must have hip involvement, but at least one remaining hip joint. Candidates are     recruited from among patients enrolled in protocol 00-HG-0141, Clinical, Biochemical, and     Molecular Investigations into Alkaptonuria. Participants may enter both protocols     simultaneously.      Participants are randomly assigned to one of two treatment groups: one group takes their     regular medicines plus a 2-mg nitisinone capsule daily; the other group takes only their     regular medicines. Patients taking nitisinone have blood tests to measure liver function 2     weeks and 6 weeks after starting treatment. Before starting therapy, all patients are     admitted to the NIH Clinical Center for 4-5 days to undergo the following procedures:        -  Medical history and physical examination        -  24-hour urine collection to test for sugar, protein, and other molecules        -  Blood tests for liver and thyroid function, blood counts, and blood chemistries        -  Blood and urine tests to measure tyrosine and other amino acids and homogentisic acid        -  Bone x-rays        -  Spiral CT (computed tomography) of the abdomen to detect kidney stones        -  Eye examination and evaluations by specialists in rehabilitation medicine and pain, plus          other consults in skin, brain, lung, heart, and kidney, as needed      All patients, whether or not they receive nitisinone, return to the Clinical Center for a 2-3     day follow-up admission every 4 months for a history and physical examination, blood tests,     and two 24-hour urine collections. Every 12 months (12, 24 and 36 months after starting the     study), patients also have repeat bone x-rays, spiral CT, kidney ultrasound, echocardiogram,     and electrocardiogram. An MRI of the brain is done at the end of the study.      Sixteen months after the end of the study enrollment period, the treated and non-treated     groups are evaluated. If nitisinone has delayed the progression of joint disease in the     treated group, the study continues and all patients receive the drug for the remainder of the     study. If not, the study continues for another 20 months, at which time the study ends and     the evaluation process is repeated.      Patients who develop symptoms such as corneal crystals, pain, or severe liver or nervous     system toxicity may be taken off the study.   "
173716|NCT00107796|"     Primary Objectives: The primary objectives of the study are to determine the effectiveness of     PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive     sleepiness (ES) associated with narcolepsy, as assessed by:        -  mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps          performed at 0900, 1100, 1300, and 1500) at the last post-baseline observation (week 6          or early termination)        -  the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last          post-baseline observation (week 6 or early termination).   "
173717|NCT00107809|"     The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment,     compared to placebo treatment, in children and adolescents with excessive sleepiness (ES)     associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), as assessed by:        -  mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps          performed at 0900, 1100, 1300, and 1500) at the last post baseline observation (week 6          or early termination)        -  the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post          baseline observation (week 6 or early termination).   "
173718|NCT00107822|"     The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin     numbing cream) applied on healthy skin before a painful dermatologic procedure in children.     This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.   "
173719|NCT00107835|"     The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin     numbing cream) applied on healthy skin before a painful dermatologic procedure in adults.     This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.   "
173720|NCT00107848|"     The primary objective of the study is to evaluate the safety and tolerability of treatment     with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with     narcolepsy or OSAHS (obstructive sleep apnea/hypopnea), when administered for up to 12     months. Safety and tolerability will be evaluated throughout the study by means of adverse     event information, clinical laboratory test results, vital signs measurements, and body     weight and height measurements; quarterly physical examination findings; and 12 lead     electrocardiograph (ECG) evaluations at the end of the study. In addition, the cognitive and     behavioral effects of PROVIGIL will be assessed quarterly as measured by the Child Behavior     Checklist for Ages 6-18 (CBCL/6-18), a brief psychiatric interview, and the Kaufman Brief     Intelligence Test (KBIT 2).   "
173721|NCT00107861|"     This study will be conducted in subjects with refractory colorectal carcinoma with     unresectable liver metastases. The purposes of the study are:        -  to evaluate the safety and any harmful effects of an intravenous injection of Ad.hIFN-β;        -  help determine whether the virus carrying the interferon-beta gene will enter the          bloodstream and liver tumor cells and cause the cancer cells to die.   "
173722|NCT00107874|"     Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and     mortality, both in developed and developing countries.      With this trial, we sought to determine the effectiveness of oral misoprostol as an     uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH     undergoing non-scheduled Cesarean section.      We therefore compared the intra- and postoperative blood loss, as well as drug related side     effects in patients, treated by the same surgical and anesthesiological team in one     institution.   "
173723|NCT00107887|"     The purpose of this study is to determine if implementing a policy of widespread INH     (Isoniazid) prophylaxis therapy in HIV-infected patients with access to antiretroviral     therapy reduces the incidence of active TB disease in the HIV clinic population.   "
173724|NCT00107900|"     Patients who undergo total hip replacement surgery are at greater risk of getting deep vein     thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of     the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients     having total hip replacement surgery.   "
173725|NCT00107913|"     This study is designed to evaluate the efficacy and safety of single agent Doxil in the     treatment of patients with refractory ITP (Idiopathic Thrombocytopenic Purpura).   "
173726|NCT00107926|"     The purpose of this study is to evaluate the effectiveness and tolerability of an     investigational drug for the treatment of manic episodes of bipolar disorder. The     investigational drug will be given as additional treatment with either lithium or valproate,     which are already FDA (Food and Drug Administration)-approved treatments for mania.   "
173727|NCT00107939|"     The purpose of this study is to evaluate the effectiveness and tolerability of an     investigational drug for the treatment of manic episodes of bipolar disorder. The     investigational drug will be given as additional therapy to one of the five following     medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These     medications are already FDA (Food and Drug Administration)-approved treatments for mania.   "
173734|NCT00108030|"     The specific aim of this project is to improve walking ability in persons following stroke     using 'treadmill training plus power training'. This modality addresses the two major     impairments followings stroke: weakness and incoordination, as well as loss of fitness.     Importantly, this training will be presented at higher intensity and greater volume than is     currently received. Furthermore, to ensure that persons continue to maintain the level of     improvement from an intensive exercise program, we will also implement a behavioral change     for long-term maintenance of exercise behavior in a less supervised environment. A randomized     controlled clinical trial will be conducted in 102 sub-acute stroke patients to ascertain the     efficacy of this approach to improving walking ability.      Hypotheses:        1. Walking endurance will be increased to a greater degree in a patient group receiving          treadmill plus muscle power training compared with a treadmill training only group, or          'usual care' group.        2. Gait stability, muscle function, aerobic fitness and balance will improve more in a          group receiving treadmill plus muscle power training, than either those in treadmill          training or usual care patient groups.        3. Habitual activity levels will be higher in the group receiving treadmill plus muscle          power training compared with a treadmill training only group or 'usual care' group.        4. The change in 6-minute walk distance will be positively related to changes in muscle          power, strength and endurance, aerobic fitness, gait mechanics, and balance.        5. Baseline depression and low self-efficacy will be associated with less robust          adaptations to all types of training and lower rates of long-term compliance to the          exercise prescription in the experimental groups.   "
173735|NCT00108043|"     Objective:      The objective of this research is to undertake a safety and viability study of FES-evoked     stepping in individuals with paraplegia. The rationale for this objective is based upon the     need to clarify whether physiological limitations, especially orthostatic intolerance, limit     functional mobility outcomes. The cardiovascular, autonomic, and muscle metabolic factors     governing orthostatic tolerance during skin-surface FES stepping will be investigated, since     this functional task forms the basis of upright mobility and engenders strong physiological     challenges upon key regulatory processes in the SCI (spinal cord injury) patient.      Specific Hypotheses:      i. Reduction of blood pressure will be greater during FES-evoked stepping than during passive     stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no     upper body component versus FES-stepping with an upper body component; iii. Blood pressure     will be reduced even further during FES-evoked stepping following a 6-week     progressive-intensity gait training intervention.   "
173736|NCT00108056|"     This study will examine the safety of a twice-a-day dosing regimen of the experimental drug     Enzastaurin in patients with malignant glioma (a cancerous brain tumor) who are and who are     not taking certain anti-seizure medicines. Enzastaurin may prevent the formation of new blood     vessels that tumors need to grow. It has shown some effect against brain tumors in animals     and in some patients with recurrent gliomas. This study will see if the drug can help     patients with gliomas and how much drug they should be given.      Patients 18 years of age and older with malignant glioma that has recurred after standard     therapy may be eligible for this study. Candidates are screened with a physical examination,     blood and urine tests, magnetic resonance imaging (MRI) or computed tomography (CT) scans,     and an electrocardiogram.      Participants are divided into two groups of patients-those who are and those who are not     taking certain anti-seizure medications-in order to determine if the anti-seizure medication     alters the way the body handles Enzastaurin. Patients in both groups are further divided into     different dosing regimens: some in each group take Enzastaurin once a day for 3 weeks,     followed by twice a day for 3 weeks; others in the group take the drug twice a day for 3     weeks followed by once a day for 3 weeks. The medication is taken by mouth every day.     Treatment is given in 6-week cycles and may continue for 1 year unless the tumor grows or the     patient develops unacceptable drug side effects. In addition to drug treatment, patients have     the following tests and procedures:        -  Medical history, physical, and neurological examinations every 3 weeks during the first          cycle and then every 6 weeks.        -  MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and          radio waves to produce images of body tissues and organs. CT uses x-rays to provide          3-dimensional views of the part of the body being studied. For both procedures, the          patient lies on a table that slides into the cylindrical scanner.        -  Routine blood tests every week during the first cycle and every 3 weeks after that.        -  Electrocardiogram on days 21 and 42 of the first cycle, just before taking the drug and          30 minutes and 4 hours after taking the drug.        -  Pharmacokinetic studies within 3 days of day 21 of the first cycle. Several blood          samples are drawn to measure levels of Enzastaurin. Patients taking the drug once a day          have blood samples drawn before the morning dose and 1, 2, 4, 6 and 24 hours after the          dose. Patients taking the drug twice a day have samples drawn before the morning dose,          at 1, 2, 4, 6 and 12 hours after the dose, and then 12 hours after the evening dose. In          addition, on day 1 an extra tube of blood is drawn at the time of the Enzastaurin dose          and 4 hours later.        -  Dynamic MRI with spectroscopy or PET. These tests are done to help distinguish live          tumor from dying tumor. The experience of dynamic MRI with spectroscopy is the same as          standard MRI and is done at the same time as the standard procedure. PET uses a          radioactive substance to show cellular activity in specific tissues of the body. The          patient is given an injection of a sugar solution in which a radioactive isotope has          been attached to the sugar molecule. A special camera detects the radiation emitted by          the radioisotope, and the resulting images show how much glucose is being used in          various parts of the body. Because rapidly growing cells, such as tumors, take up and          use more glucose than normal cells do, this test can be used to show active tumors.   "
173737|NCT00108069|"     This study will determine whether the drugs tamoxifen and bortezomib can delay tumor growth     in patients with recurrent glioma (malignant brain tumor). Tamoxifen may work by interfering     with the internal signaling needed for the cancer to grow. Bortezomib may also interfere with     tumor growth processes. Laboratory studies show that low doses of bortezomib significantly     enhance glioma cell death when used with tamoxifen.      Patients 18 years of age and older with glioma whose tumor does not respond to standard     medical treatment and who are not taking enzyme-inducing anti-seizure medications such as     Dilantin, phenobarbitol, or Tegretol, may be eligible for this study. Candidates are screened     with a physical examination, blood tests, and magnetic resonance imaging (MRI) or computed     tomography (CT). MRI and CT scans produce images of the brain that can show if the brain     tumor is growing (see below).      Participants receive treatment in 6-week cycles for up to 1 year. (The treatment duration may     be extended in some patients who continue to tolerate the drug and show no signs of tumor     growth after 1 year.) During each cycle, patients take six tamoxifen tablets twice a day     every day and receive bortezomib by infusion into a vein on days 3, 6, 10, 13, 24, 27, 31 and     34. Treatment may continue as long as the tumor does not grow and the patient does not     develop unacceptable side effects. In addition to drug treatment, patients undergo the     following tests and procedures:        -  Periodic routine blood tests.        -  MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and          radio waves to produce images of body tissues and organs. CT uses x-rays to provide          3-dimensional views of the part of the body being studied. For both procedures, the          patient lies on a table that slides into the cylindrical scanner.        -  Blood test to measure levels of bortezomib. Blood is drawn before the bortezomib          infusion on days 3 and 24, and 4 hours after the infusion on day 24 of the first          treatment cycle only.        -  Dynamic MRI with spectroscopy or positron emission tomography (PET). Patients may be          asked to undergo one of these tests, which help distinguish live tumor from dying tumor.          The experience of dynamic MRI with spectroscopy is the same as standard MRI and is done          at the same time as the standard procedure (see above). PET uses a radioactive substance          to show cellular activity in specific tissues of the body. The patient is given an          injection of a sugar solution in which a radioactive isotope has been attached to the          sugar molecule. A special camera detects the radiation emitted by the radioisotope, and          the resulting images show how much glucose is being used in various parts of the body.          Because rapidly growing cells, such as tumors, take up and use more glucose than normal          cells do, this test can be used to show active tumors.        -  Drug diary. Patients maintain a calendar to record when they take their study drugs and          what side effects they develop.   "
173738|NCT00108082|"     This study is designed to compare the effects of COREG MR (carvedilol modified release     formulation) to atenolol on indices of left ventricular dimensions when added to standardized     angiotensin converting enzyme (ACE) inhibition, and to the effect of ACE inhibition alone.     Subjects with LVH (left ventricular hypertrophy) and hypertension will be studied. The     primary endpoint will be the change in left ventricular mass index (LVMI) characterized by     magnetic resonance imaging (MRI) following 12 months of treatment. Secondary endpoints     include the change in LV (left ventricular) mass, LV wall thickness, diastolic left     ventricular filling parameters, and left ventricular ejection fraction by echocardiographic     methods at Treatment Month 12. Composite outcomes and individual event data will also be     evaluated by treatment group.   "
173739|NCT00108095|"     This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both     safety and effectiveness in prevention PONV   "
173740|NCT00108108|"     The purpose of this study is to determine the highest tolerated dose, safety and activity of     HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior     treatment.   "
173741|NCT00108121|"     The purpose of this study is to determine whether topical application of PEP005 is safe for     the treatment of nodular basal cell carcinoma.   "
173742|NCT00108134|"     The purpose of this study is to determine whether topical application of PEP005 is safe for     the treatment of superficial basal cell carcinoma.   "
173743|NCT00108147|"     The goal of this study is to determine the effect of a functional circuit training program as     compared to standard cardiac rehabilitation or control exercise in improving physical     function and activity.   "
173744|NCT00108160|"     The purpose of this study is to determine if mupirocin 2% in polyethylene glycol (PEG)     ointment [Treatment Arm] is effective in preventing moderate to severe re-infection with     Staphylococcus aureus compared with treatment with polyethylene glycol (PEG) ointment     [Placebo Arm].   "
173745|NCT00108173|"     The purpose of the study was to determine how the treatments for cigarette craving work.      Hypothesis: During exposure to cigarette-related cues, heavy smokers will have greater     reductions in regional brain activation from before to after both forms of active treatments     than from before to after placebo.   "
173772|NCT00108537|"     The primary objective of this study is to determine which is the better approach to smoking     cessation in veterans: bupropion combined with transdermal nicotine or high dose nicotine     replacement therapy (NRT) using transdermal nicotine combined with nicotine inhaler.   "
173746|NCT00108186|"     This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T     regulatory cell activities and thus augment immune responses against lung cancer. The broad     goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non     small cell lung cancer in an effort to foster an informed approach for the use of COX-2     inhibitors in prevention and therapy for lung cancer.   "
173747|NCT00108199|"     This study examines whether patients with schizophrenia can benefit from a problem-solving     training intervention and whether a work-related social skills training intervention leads to     improvements in the patient's performance at work.   "
173748|NCT00108212|"     The purpose of this study is to evaluate different diets and the effects of blood measures or     inflammation and endothelial function in association with genetics tending to abnormal blood     test levels.   "
173749|NCT00108225|"     In this study we tested the hypothesis that an increase in protein content of the diet will     result in an increase in the 24-hour integrated circulating growth hormone (GH) and     insulin-like growth factor-1 (IGF-1) concentrations and an increase in lean body mass in     people with untreated type 2 diabetes.   "
173750|NCT00108238|"     Healthy postmenopausal women not currently taking hormone replacement or hormone modulating     therapy take a 3-month course of estradiol/raloxifene/placebo to evaluate the effects of each     on vascular function, as indicated by PET coronary flow reserve studies and brachial artery     ultrasound, before and after use of the therapies. This is a randomized, placebo-controlled,     blinded study.   "
173756|NCT00108316|"     This study is designed to understand if a biological measurement, of how platelets respond to     serotonin (a chemical in the blood sometimes referred to as SERT), can provide information     that will determine an ideal dose, one specifically tailored for each individual's     chemistry. The biological measurement will be obtained by testing a blood sample. There will     be approximately 120 control subjects expected for enrollment.   "
173757|NCT00108329|"     This study examines the effects of weight loss and aerobic exercise training on sugar     metabolism and other risk factors for heart disease in obese older individuals.   "
173758|NCT00108342|"     The purpose of this study is to determine whether sampling nicotine replacement treatments     (NRTs) is superior to learning about them by computer. Testing also covers preferences among     the treatments. Subjects will be enrolled veterans who smoke.      Hypothesis: Direct experience (sampling) of NRTs will increase knowledge about NRTs,     motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by     computer.   "
173759|NCT00108355|"     This clinical trial compares a combination of two drugs that constrict blood vessels     (Octreotide LAR and Midodrine) to albumin after large volume paracentesis. Subjects have     cirrhosis and ascites.   "
173760|NCT00108368|"     The goal of this research is to find ways to maximize the benefits of antipsychotic     medications for cognition.      Hypothesis: Risperidone and olanzapine will show greater benefits than conventional     medications on assessments of social cognition, particularly affect perception and social     perception.   "
173761|NCT00108381|"     This clinical trial compares two psychological treatments for back pain.   "
173762|NCT00108394|"     The purpose of this study is to demonstrate whether pamidronate will preserve or increase     bone mass in patients with adynamic bone disease, caused by low bone turnover.   "
173763|NCT00108407|"     The purpose of this study is to determine whether Integrated Cognitive Behavioral Therapy or     Twelve Step Facilitation Therapy is most effective for treatment of dually diagnosed veterans     with depressive and substance use disorders.   "
173764|NCT00108420|"     The purpose of this study is to determine whether prazosin will reduce the incidence of     nightmares, sleep disturbance, and overall symptoms in combat trauma-exposed individuals with     PTSD.   "
173765|NCT00108433|"     This study will treat hemodialysis patients who have a central catheter that is thought to be     infected with a specific bacteria (Gram positive bacteria).   "
173766|NCT00108446|"     This study is being done to collect new information on irritable bowel syndrome, a disease     that causes abdominal pain that does get better with treatment or keeps coming back     (chronic). To better understand what causes the irritable bowel syndrome, we are studying     drugs used to treat pain, dextromethorphan, naloxone, fentanyl, and lidocaine. We will study     the effects these drugs have on experimental pain.      Dextromethorphan is used in non-prescription cough syrups. Naloxone is used for reversing the     effects of narcotic pain relievers. Fentanyl is a narcotic used to treat pain and to make a     person relaxed (sedated) before anesthesia. The purpose of this study is to see what kinds of     pain are affected by these drugs in persons who have irritable bowel syndrome and persons who     do not have this problem.   "
173767|NCT00108459|"     This study is designed to address the hypothesis that in obese patients with type 2 diabetes     mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to     low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body     weight in patients with obesity and type 2 DM, be safe, and will not have any detrimental     effects on serum lipid concentrations.   "
173768|NCT00108485|"     The primary purpose of this study is to test the effectiveness and tolerability of Niaspan®     to improve the levels of blood fats (good and bad cholesterol and triglyceride levels) in     people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan®     slows down further development of kidney damage.   "
173769|NCT00108498|"     This study will determine if mirtazapine, a unique antidepressant that does not disturb     sleep, will improve obstructive sleep apnea (OSA). The design is randomized, crossover,     double blind, and placebo controlled. On two consecutive nights of one week, the patients     receive either 30 mg mirtazapine or placebo at bedtime. The following week, the alternative     medication is administered. The patients have known mild to moderate sleep apnea. The     endpoints of the study are the apnea + hypopnea index (AHI), sleep quality, and the degree of     arterial oxygen desaturation.   "
173770|NCT00108511|"     The purpose of this study is to examine the role of glycosylphosphatidylinositol-specific     phospholipase D (GPI-PLD) in triglyceride metabolism.   "
173771|NCT00108524|"     This study compares two types of diet interventions: a low carbohydrate ketogenic diet     (Atkins) and a low-fat diet combined with a medication (Orlistat).   "
173773|NCT00108550|"     The purpose of this study is to determine whether gabapentin is efficacious as an analgesic     for chronic low back pain.   "
173774|NCT00108563|"     The purpose of this study is to learn more about the effects of interferon and ribavirin     combination therapy in people with Hepatitis C. The specific aims are:        -  To assess how often depressive symptoms occur in patients taking combination alpha          interferon plus ribavirin or pegylated interferon plus ribavirin therapy for Hepatitis          C, when depressive symptoms occur, and how severe the depressive symptoms are when they          do occur;        -  To identify potential predictors for the development of depressive symptoms;        -  To identify if citalopram, an antidepressant medication, can prevent or lessen the          severity of depressive symptoms brought about by interferon therapy.   "
173775|NCT00108576|"     The purposes of this study are:        -  To study the efficacy of divalproex in the treatment of PTSD;        -  To study the plasma GABA (gamma aminobutyric acid) levels before and after treatment          with divalproex in PTSD.   "
173849|NCT00117039|"     The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg     every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and     maintaining hemoglobin levels consistent with the National Comprehensive Cancer Network     (NCCN) guidelines).   "
173776|NCT00108589|"     The purpose of this study is to examine the effect of S-adenosylmethionine therapy in those     patients with non-alcoholic liver disease in the form of steatohepatitis (NASH). This will be     accomplished by development of a database of these patients, all of whom will have biopsy     documented NASH. A placebo controlled trial will then examine the effect of     S-adenosylmethionine over time on clinical outcome in these patients. It is expected that     this agent will slow or halt the progression of this disease.   "
173777|NCT00108602|"     This study will determine the effect of ventilatory stimulation on obstructive sleep apnea in     selected patients with stroke. We will select a subset of patients with stroke in the prior 3     months who are most likely to have ventilatory instability as a cause of the upper airway     obstruction as indicated by the absence of obesity, an abnormal hypocapnic apnea threshold     and resolution of obstructive apnea during CO2 administration. Following baseline     polysomnography, patients will be randomly assigned to acetazolamide (250 mg hs [at bedtime])     versus placebo for 7 days. Polysomnography will be repeated and then subjects will cross-over     therapies for another 7 days followed by a final nocturnal polysomnography.   "
173778|NCT00108615|"     Subjects with impaired glucose tolerance will be randomized to receive pioglitazone or     metformin for 10 weeks. Measurements of insulin sensitivity, body composition, glucose     tolerance, and muscle lipid accumulation will be performed. Adipose tissue and muscle     biopsies are performed. The goal of the study is to determine whether the lipotoxiciy of     impaired glucose tolerance is ameliorated by pioglitazone.   "
173779|NCT00108628|"     The purpose of this study is to compare the effectiveness of two cognitive behavioral group     psychotherapy interventions in controlling the subjective sleep disturbance in veterans with     Post-traumatic Stress Disorder.   "
173780|NCT00108654|"     This study will determine the safety and side effects of an experimental adenoviral vector     vaccine given to patients who previously received a different HIV vaccine     (VRC-HIVDNA016-00-VP) in a prior NIAID study. The study will also monitor participants for     the social impact of being in an HIV vaccine study (e.g., problems with insurance, health     care, friends, family, employment, housing, and so forth). The study vaccine is made using an     adenovirus (a common virus that causes upper respiratory infections, such as the common cold,     eye infection, urine infection or diarrhea) that has been modified to contain DNA that codes     for three HIV proteins. The modified virus cannot reproduce in the body and cannot cause HIV     disease or adenoviral infections.      Healthy volunteers who previously received three injections of the VRC-HIVDNA016-00-VP under     the NIAID study VRC 007 (protocol 04-I-0254) may be eligible for this study.      Participants receive one injection of the adenoviral vector vaccine. It is given the day they     enroll in the study, as a single injection in an upper arm muscle. Also on that day they have     a brief physical examination, medical history, blood and urine tests, pregnancy test for     women, and counseling, as needed, about HIV and pregnancy avoidance. Subjects are observed     for side effects for at least 30 minutes after the vaccination and are required to telephone     the clinic staff 1 to 2 days after the injection for follow-up. In addition, they are given a     diary card to take home, on which they record their temperature and any symptoms daily for 5     days.      Subjects return to the clinic for 5 follow-up visits at weeks 2, 4, 6, 12 and 24 after the     injection. At each visit they are checked for health changes or problems since the last     visit, asked how they are feeling and what medications they are taking. They have blood drawn     at every visit and urine samples collected at most visits. They are tested for HIV three or     more times and are questioned about their sexual behavior and drug use. They also complete a     social impact questionnaire at the last visit.      Subjects are asked to undergo apheresis at the week 4 visit. This procedure allows collection     of a larger number of white blood cells than can be obtained by a simple blood draw. The     white cells are studied to see how the immune system responds to the study vaccine. For     apheresis, blood is collected through a needle in an arm vein and spun in a machine that     separates the components. The white blood cells are extracted and the rest of the blood is     returned to the body through the same needle. Subjects who do not undergo apheresis have     about 1/3 cup of blood sample drawn using a needle.   "
173781|NCT00108667|"     This study will evaluate the effects of the experimental drug talampanel on dyskinesias     (involuntary movements) that develop in patients with Parkinson's disease as a result of     long-term treatment with levodopa (Sinemet). The drug will be tested alone and in combination     with amantadine-a drug commonly used to alleviate dyskinesias.      Patients between 21 and 80 years of age with Parkinson's disease and dyskinesias may be     eligible for this study.      Screening and baseline evaluation. Participants are evaluated with a medical history,     physical and neurologic examinations, blood and urine tests, electrocardiogram (EKG) and     pregnancy test, if applicable. A chest x-ray and MRI or CT scan of the brain are done if     needed. Patients stop taking all antiparkinsonian medications for one month (2 months if     taking Selegiline) before the study begins and throughout its duration, except for certain     medicines allowed, including Sinemet, Mirapex and Requip. Amantadine can be taken up to 1     week before beginning the study.      Dose-finding phase. Patients are admitted to the NIH Clinical Center for 2 to 3 days for a     levodopa dose-finding procedure. For this test, patients stop taking Sinemet and instead     have it infused through a vein. During the infusions, the drug dose is increased slowly until     parkinsonian symptoms improve or unacceptable side effects occur or the maximum study dose is     reached. Symptoms are monitored frequently. At given times during the infusion, saline is     given instead of Sinemet. The infusions usually begin in the early morning and continue until     evening. Patients resume taking Sinemet between infusions. (Patients who have had dosing     infusions in the last 3 months do not have to undergo this phase of the study.)      After the dose-finding phase, patients are randomly assigned to take placebo (a sugar pill)     or talampanel. Those taking talampanel also receive amantadine at their usual dosages. At     some point in the study, amantadine is replaced with placebo. Patients in the talampanel     group also receive placebo for portions of the study.      Active study phase. At study weeks 1, 5 and 7, patients are admitted to the Clinical Center     overnight for a levodopa infusion with talampanel or placebo. The day before the infusion,     patients have a brief physical examination, blood and urine tests, an EKG, and a review of     symptoms or changes in their condition. The next day, they receive an infusion of levodopa at     the dose determined in the dose-finding phase. Then they take a pill containing either     talampanel or placebo. Their parkinsonian symptoms and dyskinesias are evaluated and     videotaped every 30 minutes for about 6 hours. Blood is drawn and an EKG is obtained. At the     end of the infusions and ratings, patients resume their regular Parkinson's medications and     are given a new supply of study medications to take home.      At weeks 2, 3, 4 and 6, patients come to the Clinical Center for a review of drug side     effects. They have blood drawn and receive a new supply of study medications that last until     the next visit.      Follow-up. Two weeks after the study ends, patients are contacted by phone for a review of     side effects or they return to the clinic for an evaluation.   "
173798|NCT00108927|"     The goal of our research program is to successfully translate empirical knowledge regarding     diabetes treatment and management into sustainable clinical practice. The study hypothesis is     that implementation of a multicomponent intervention will result in meaningful improvement in     clinical performance measures at the clinic that include average A1c (Hemoglobin A1c),     average systolic blood pressure, and national clinical performance measures at a reasonable     cost to the health system.   "
173782|NCT00108680|"     This study will compare the effectiveness of unilateral versus bilateral exercise training     for recovering movement abilities in chronic stroke patients. After a stroke, some people     have improved their movement ability by exercising the arm affected by the stroke. Others     have improved by exercising both arms together. This study will compare these two kinds of     exercise to see which might work best.      Healthy volunteers and people who have had a stroke more than 6 months ago may be eligible     for this study. Stroke patients must have some weakness in their stroke-affected arm. All     participants must be 18 years of age or older. Candidates are screened with a clinical and     neurological examination. Women who can become pregnant have a pregnancy test. Stroke     patients have a magnetic resonance imaging (MRI) study of the brain if they have not had one     in the last year.      Participants undergo the following tests and procedures:      MRI: This procedure uses a magnetic field and radio waves to produce images of body tissues     and organs. The subject lies on a table that slides into the scanner (a narrow cylinder),     wearing earplugs to muffle loud knocking sounds that occur during the scanning process. The     procedure lasts about 45 minutes, during which time the subject must lie still for up to 30     minutes.      Testing sessions: There are six test sessions - two to familiarize the subject with the     reaching test, two to do the reaching test plus transcranial magnetic stimulation (TMS)     before and after an exercise session, and two to do the reaching test plus TMS one day after     the exercise session. The sessions are on consecutive days, with a 1-week break after session     3. The procedures involved are:        -  Reaching test: The subject responds as quickly as possible to a GO signal presented on          a computer monitor by performing a reaching movement with his or her arm. The activity          from the arm muscles is recorded using surface electrodes. During this test, a          questionnaire is used to determine the subject's attention, fatigue, and mood.        -  TMS: For this test, a wire coil is held on the scalp, and a brief electrical current is          passed through the coil, creating a magnetic pulse that stimulates the brain. During the          stimulation, the subject may be asked to tense certain muscles slightly or perform other          simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg,          and the subject may hear a click and feel a pulling sensation on the skin under the          coil. The effect of TMS on the muscles is detected with small metal disk electrodes          taped onto the skin of the arms. The subject performs the reaching test while TMS is          delivered at various times after getting the GO signal.        -  Arm exercises: The subject is seated in front of an exercise device that has two handles          that slide forward and backward along a set of tracks. The subject is asked to slide          either one or both handles back and forth repeatedly, alternating 5 minutes of arm          exercise with 5 minutes of rest for 30 minutes.   "
173784|NCT00108732|"     Vaccines made from a gene-modified virus may help the body build an effective immune response     to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in     different ways and stop tumor cells from growing. Androgens can cause the growth of prostate     cancer cells. Drugs, such as bicalutamide and goserelin, may stop the adrenal glands from     making androgens in patients whose tumor cells continue to grow. Giving vaccine therapy     together with GM-CSF and, when needed, androgen ablation may be a more effective treatment     for prostate cancer. This phase II trial is studying how well giving vaccine therapy together     with GM-CSF works in treating patients with prostate cancer that progressed after surgery     and/or radiation therapy.   "
173785|NCT00108745|"     This randomized phase III trial studies paclitaxel to see how well it works compared to     polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV     ovarian epithelial, peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy,     such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and     polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer     by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need     additional treatment until it progresses. In this case, observation may be sufficient. It is     not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or     observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.   "
173786|NCT00108758|"     This trial is conducted in Africa, Asia, Europe, South America, and the United States of     America (USA).      The purpose of this study is to evaluate the effectiveness of secondary prophylactic     treatment with NovoSeven® in haemophilia A and B patients with inhibitors.   "
173787|NCT00108771|"     The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch     ZR-02-01 in providing pain relief.   "
173788|NCT00108784|"     This study will test the hypothesis that reducing the energy density of the diet by     incorporating more water-rich foods will result in: 1) greater weight loss and weight     maintenance; 2) greater diet satisfaction and satiety; and 3) more healthful dietary patterns     than reducing dietary fat alone.   "
173789|NCT00108797|"     This trial is conducted in the United States of America (USA). This study compares the     effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with     inhibitors being treated for joint bleeds.   "
173790|NCT00108810|"     The purpose of the study is to evaluate the safety and effectiveness of the investigational     ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance)     for the treatment of pain caused by osteoarthritis.   "
173791|NCT00108823|"     The purpose of this trial is to study the effects of roflumilast on lung function parameters     indicative of hyperinflation in patients with COPD.   "
173792|NCT00108836|"     This study will test the efficacy, safety and tolerability of XBD173 in the treatment of     generalized anxiety disorder in patients.   "
173793|NCT00108849|"     This trial is conducted in North America. The purpose of this study is to determine if     Vagifem Low Dose is an effective and safe treatment for patients suffering from     postmenopausal atrophic vaginitis.   "
173794|NCT00108862|"     The purpose of this study is to determine the best time to begin anti-HIV treatment in     individuals who have HIV and tuberculosis (TB).      Study hypothesis: Immediate antiretroviral therapy (ART), initiated after approximately 2     weeks of TB treatment, will reduce the frequency of other AIDS-defining illnesses and death     in HIV-infected participants being treated for TB by at least 40% at week 48 when compared to     deferred ART, initiated at after 8-12 weeks of TB treatment.   "
173795|NCT00108875|"     This study evaluates the safety, the immunological response and the clinical outcome of a     vaccination with survivin peptides for patients with advanced melanoma, pancreatic, colon and     cervical carcinoma.   "
173796|NCT00108901|"     The study is a behavioral clinical trial of aerobic exercise to determine dose-response     effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other     cardiovascular risk factors in overweight elementary schoolchildren.      The hypothesis is that the more exercise a child does, the more benefit he or she will gain     in reducing the risk of diabetes and other cardiovascular diseases.      An ancillary study examined effects on cognition and achievement.   "
173797|NCT00108914|"     The purpose of this study is to determine if the investigational drug is effective and safe     in children with perennial allergic rhinitis.   "
173799|NCT00108940|"     The purpose of this study is to find the genes that increase the risk of developing an     ischemic stroke using DNA samples collected from concordant (stroke-affected) sibling pairs.   "
173801|NCT00108979|"     Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are     selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults.     This study is designed to evaluate the efficacy, safety, and pharmacoeconomics of     escitalopram and an active comparator in patients with major depressive disorder.   "
173802|NCT00108992|"     Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the     symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side     effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney     abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the     knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is     to determine the safety and effectiveness of a topical NSAID when used alone or when combined     with an oral NSAID in the treatment of osteoarthritis of the knee.   "
173803|NCT00109005|"     This study will test whether an experimental drug called Revlimid (lenalidomide) can reduce     tumor size and prolong survival in patients with metastatic melanoma (melanoma that has     spread beyond the original tumor site). It will also examine the toxicity and blood effects     of Revlimid.      Patients 18 years of age and older with stage IV ocular melanoma may be eligible for this     study. Candidates are screened with a medical history and physical and examination, blood and     urine tests, electrocardiogram, chest x-ray, computed tomography (CT) scan and other imaging     scans if needed, such as a bone scan, magnetic resonance imaging (MRI), ultrasound, or     positron emission tomography (PET).      Participants are admitted to the National Institutes of Health (NIH) Clinical Center for 24     hours for their first oral dose of Revlimid. During the hospital stay, blood is drawn before     the dose is given and again at 0.25, 0.5, 1, 2, 4, 6, 9, 12 and 24 hours after dosing to see     how the body handles the drug. If the drug is well tolerated, patients are sent home with a     21-day supply of drug to take once a day for 21 days, then go off drug 7 days. This regimen     constitutes one 28-day treatment cycle. Treatment cycles may continue for up to 2 years.      Patients keep a daily diary of side effects and have blood drawn once a week. The drug dose     may be adjusted according to the laboratory test results. If unacceptable toxicity occurs,     treatment may be stopped.      Patients who agree to be biopsied undergo this procedure before treatment begins and at the     end of treatment cycles 3 and 6. A small area of skin is numbed with medicine and a small     piece of tumor is removed with a needle or by a small cut in the tumor. The tissue is     examined under a microscope.      Patients return to NIH after the first month of treatment and then every 3 months to evaluate     their tumors and treatment of side effects. The visits include a physical examination, x-rays     and scans to evaluate tumors. Visits are scheduled every 3 months while on treatment; then     every 3 months for 2 years afterwards; then every 4 months for 1 year; and as needed after     that. Patients will have a brain magnetic resonance imaging scan once a year to watch for new     tumor areas.   "
173804|NCT00109018|"     Biomarkers for Cardiovascular Disease      Summary: This study will examine the function of the lining cells of blood vessels and     measure substances in the blood to see how they relate to various blood tests, including new     tests under development to determine cardiovascular disease risk. Nitric oxide is a molecule     produced by healthy blood vessels that helps keep them relaxed. Nitrate is a substance formed     from nitric oxide in the blood. The release of nitric oxide by blood vessels is reduced in     patients with coronary artery disease, compared with healthy people. Also, blood nitrite     levels rise in some of these patients. Other substances in the blood and urine also change     with risk for heart disease. This study will measure nitrite levels and other inflammatory     substances in the blood and urine.      Healthy volunteers, people with various risk factors for heart disease, and people with     blockage of one or more major heart arteries or a history of heart attack may be eligible for     this study. Candidates must be 21 years of age or older. People who have an irregular heart     rhythm or who cannot take oral nitrates are excluded.      Participants undergo the following tests and procedures:        -  Blood tests: Samples are drawn three times for routine tests and to look for certain          proteins that may affect the heart. Samples are collected once before any other tests,          once before starting the exercise stress test (see below) and again after the stress          test.        -  Urine test: A sample may be tested for proteins in the urine and for other research          studies.        -  Brachial artery reactivity study: This ultrasound study tests how well a person's          arteries widen. The subject rests on a bed. An ultrasound measuring device is placed          over the artery just above the elbow. The size of the artery and blood flow through it          are measured before and after inflating a pressure cuff around the forearm. The pressure          cuff stops the flow of blood to the arm for 5 minutes and then is released while more          ultrasound pictures are taken. After the subject rests, a nitroglycerin tablet (medicine          that causes blood vessels to relax) is placed under the tongue. After the nitroglycerin          is given, the size of the artery and blood flow through it are measured again. After a          rest period, the study will be repeated in the healthy volunteers and first 20 patients          with heart disease.        -  Echocardiography (heart ultrasound): This test involves holding a small probe against          the chest to use sound waves for obtaining pictures of the heart. A small catheter          (plastic tube) may be placed in a vein to inject a contrast agent that enhances the          pictures.        -  Metabolic stress testing: Subjects will be asked to breathe in and out of a mask while          baseline measurements are taken. Then they exercise on a treadmill while wearing a          breathing mask. This test shows how much oxygen the body uses at rest and with exercise.        -  Genetic testing (optional): A blood sample is collected to examine DNA - genetic          material that determines inherited traits and contains information about body proteins.          Some parts of DNA may be used as markers of the level of damage produced by oxygen          by-products that may reflect the extent of heart disease in patients. Also, gene          variations may make an individual more likely to develop a heart problem. Such markers          may guide doctors in predicting how fast the disease will progress or may help find a          new type of drug to prevent disease.        -  Time requirements: This study is expected to take approximately 5-6 hours for completion          within one or two days.        -  Follow-up: Patients are contacted by phone every 6 months for information on chest pain,          surgical procedures related to the heart, and hospitalizations.   "
173805|NCT00109031|"     To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3     consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World     Health Organization [WHO] grade 3 and 4).   "
173806|NCT00109044|"     Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are     selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults.     This study is designed to evaluate the efficacy and safety of a fixed-dose escitalopram     combination relative to its component monotherapies and to placebo in patients with major     depressive disorder.   "
173807|NCT00109057|"     This is a multicenter, open-label extension study. Subjects who have received rhuMAb VEGF     (Avastin) therapy in any Genentech-sponsored Phase I or Phase II cancer study and who did not     show evidence of disease progression at completion of the parent study will be eligible for     inclusion in this trial.   "
173808|NCT00109070|"     This is a multicenter, Phase III, randomized, active-controlled trial to evaluate the     efficacy and safety of rhuMAb VEGF (Avastin) added to the standard first-line chemotherapy     used to treat metastatic colorectal cancer. This trial will enroll approximately 900 subjects     with histologically confirmed, previously untreated, bi-dimensionally measurable metastatic     colorectal cancer.   "
173809|NCT00109083|"     The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment     in reducing the number of migraine headaches when added to a person's usual medications for     acute migraine headache relief.   "
173810|NCT00109096|"     The purposes of this study are to determine: - whether standard or higher doses of pemetrexed     should be given to patients with ovarian or primary peritoneal cancer that has recurred; -     the safety and side effects of standard and higher doses of pemetrexed given to patients with     ovarian or primary peritoneal cancer that has recurred; - whether standard or higher doses of     pemetrexed can help patients with ovarian or primary peritoneal cancer that has recurred.   "
173811|NCT00109109|"     The purposes of this study are:        -  To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14          consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6          weeks) in patients with advanced multiple myeloma;        -  To assess the safety and overall response rate to SAHA in patients with advanced          multiple myeloma.   "
173812|NCT00109122|"     The purpose of this study is to determine the immunity (the body's protection) against     shingles after receiving two doses of an investigational vaccine or placebo (a look alike     vaccine with no active ingredients).   "
173813|NCT00109135|"     The purpose of this study is to evaluate the safety and tolerability of an investigational     drug that may help individuals to stop smoking.   "
173814|NCT00109148|"     The purpose of this study is to determine the safety and effectiveness of an investigational     drug in patients with obesity (considerably overweight).   "
173815|NCT00109161|"     This research study is being conducted in the U.S. and Europe to evaluate the safety and     efficacy of daclizumab for the treatment of multiple sclerosis (MS).   "
173816|NCT00109174|"     This study will use magnetic resonance spectroscopy (MRS) to measure in the brain the     transfer of [13]C as it is naturally metabolized from glucose to specific chemical     transmitters. From this method, we can measure the rate of production of an important     excitatory neurotransmitter (glutamate) as well as an inhibitory neurotransmitter (GABA).   "
173817|NCT00109187|"     This is a Phase IIIb, multicenter, open-label, extension study available to subjects who     successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should     be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their     baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects     in the New Treatment Group may require additional visits for study drug injections (as     frequently as every 2 weeks). Data collection during these additional visits will be limited     to the assessment of adverse events. The study will evaluate all serious and nonserious     adverse events, laboratory assessments, data on asthma exacerbations, and concomitant     medication usage.   "
173818|NCT00109200|"     This is a continued access protocol to provide subjects who have completed Genentech, Inc.     Study Q2143g, Q2195g, or Q2461g or Novartis Pharmaceuticals Corporation Study CIGE025 0010E1     with continued Xolair treatment. Subject eligibility will be based on disease severity and     asthma deterioration upon withdrawal of Xolair treatment. Subjects whose last Xolair dose was     <9 months prior to screening visit will continue with the same Xolair dosing regimen that     they received in the previous Genentech or Novartis clinical study.   "
173850|NCT00117052|"     The purpose of this study is to demonstrate that the efficacy of cinacalcet when     co-administered with the first meal after dialysis is comparable (non-inferior) to the     efficacy of cinacalcet when administered during the dialysis study visit.   "
173851|NCT00117065|"     The purpose of this study was to evaluate Aranesp® administered subcutaneously (SC) to     maintain hemoglobin (Hb) levels in renal transplant recipients.   "
173819|NCT00109213|"     The purpose of the study is to determine the proper use of lower back screws and rods     (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing     (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another     (spondylolisthesis). There are two types of operations that surgeons perform for this     problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the     nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is     also important to strengthen the back by placing screws and rods into the spine and adding     more bone to obtain a new bridge of bone away from the nerves (decompression with     instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion     to a decompression for this spinal problem will improve long term patient outcomes.   "
173820|NCT00109226|"     This Phase II, multicenter, double-blind, randomized, active-controlled trial is designed to     evaluate the efficacy and safety of rhuMAb VEGF (Avastin) when administered at a dose of 5     mg/kg every 2 weeks in combination with 5 FU (fluorouracil)/leucovorin versus 5 FU/leucovorin     alone in subjects with previously untreated metastatic colorectal cancer who are not optimal     candidates to receive first-line CPT-11 (irinotecan). A total of 48 doses of rhuMAb VEGF may     be administered during this study (maximum of 96 weeks of therapy).   "
173821|NCT00109239|"     This Phase III, multicenter, randomized, active-controlled, open-label trial is designed to     evaluate the efficacy, safety, and pharmacokinetics of rhuMAb VEGF when combined with     capecitabine compared with capecitabine alone in subjects with previously treated metastatic     breast cancer.   "
173822|NCT00109252|"     This is an open-label, multicenter study designed to evaluate the efficacy and safety of     efalizumab administered at weekly SC (subcutaneous) doses of 1.0 mg/kg followed by efalizumab     taper in subjects with plaque psoriasis who previously participated in Study ACD2390g.   "
173823|NCT00109265|"     This is a Phase II, multicenter trial of single-agent treatment with OSI 774 in patients with     histologically confirmed, incurable, locally advanced or metastatic breast cancer. Patients     must have measurable disease.   "
173824|NCT00109278|"     The purpose of this study is to test the safety of a measles, mumps, and rubella study     vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA     (recombinant human albumin).   "
173825|NCT00109291|"     To evaluate the safety profile of single intravenous (IV) dose levels of peginesatide in     participants with chronic kidney disease(CKD) not on dialysis.   "
173826|NCT00109304|"     This study is being done to determine the safety and tolerability of a new investigational     vaccine referred to as VEE IA/B V3526, which may induce production of specific antibodies in     vaccinated humans, and may protect them against infection with the Venezuelan Equine     Encephalitis (VEE) Virus.   "
173827|NCT00109317|"     This is a Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled,     multicenter study designed to evaluate the safety and tolerability of efalizumab administered     subcutaneously at weekly doses of 1.0 mg/kg in subjects with moderate to severe plaque     psoriasis who are candidates for systemic therapy.   "
173828|NCT00116766|"     Isolated minority communities in China use traditional plant-based methods of mosquito     control. This study is evaluating 4 plants used in this way by monitoring mosquitoes entering     houses on nights when the plants are being used in this way. A blind, placebo controlled     study design will monitor plant use and record mosquito species / numbers caught in CDC light     traps indoors over 3 months.   "
173829|NCT00116779|"     The purpose of the study was to contribute, along with other such dose-finding studies, to     the identification of the most effective treatment regimen for a one month depot injection of     degarelix in the treatment of prostate cancer by a rapid and sustained suppression of     testosterone.   "
173830|NCT00116792|"     We hypothesize that the combination of the thin-strut MULTI-LINK (i.e. VISION(tm) and/or     MINI-VISION(tm)) stent and pharmacologic therapy with the oral PPAR-gamma agonist     rosiglitazone will significantly reduce restenosis after intracoronary stenting in type 2     diabetic patients. This approach would present a more effective and economical alternative to     the use of drug-eluting stents to reduce stent restenosis.   "
173831|NCT00116805|"     The primary objectives of this study are to compare the efficacy, safety, and tolerability of     tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of     HBeAg-positive chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks     (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to     480 weeks.   "
173832|NCT00116818|"     The purpose of this study is to assess the effect of an aqueous nasal spray investigational     compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system     in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study     can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include     physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and     allergy skin testing. You will need to complete a daily diary card and spend the night in the     clinic on 2 occasions to collect urine and blood samples over 24 hour periods.   "
173833|NCT00116831|"     The purpose of this study is to test the safety and effectiveness of rosiglitazone against a     sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels     of the heart.   "
173834|NCT00116844|"     Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for     60 days in a two-way crossover study with a washout period of 7 days between treatment     periods.   "
173837|NCT00116883|"     The purpose of this study is to assess the effect of an aqueous nasal spray investigational     compound GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA)     axis system in children 2 to 11 years of age with perennial allergic rhinitis.   "
173838|NCT00116896|"     This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and     OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors.   "
173840|NCT00116922|"     It is now well established that the 21st century will be characterized by a global epidemic     of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals     with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing     to diabetes with a healthy living lifestyle intervention and an insulin sensitizing     medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral     glucose tolerance test will be eligible to participate in this study. All participants will     receive a lifestyle dietary and exercise intervention program. Half of the participants will     be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is     commonly used to treat Type 2 diabetes. The primary outcome for this study is the development     of diabetes. The study is expected to last a total of five years.   "
173841|NCT00116935|"     In this study, patients who have been diagnosed with gastrointestinal stromal tumor (GIST)     will be randomly allocated in a 1:1 ratio to receive imatinib (Gleevec) either for 12 or for     36 months following surgery. The study participants are required to have a histologically     verified GIST with a high risk of GIST recurrence despite complete removal of all macroscopic     GIST tissue at surgery. The high/very high risk of recurrence is defined as one of the     following: 1) the largest tumor diameter is over 10 cm; 2) the mitosis count is high (over 10     mitoses per 50 high power microscope fields, HPFs); 3) the largest tumor diameter over 5 cm     and the mitosis count is over 5/50 HPFs; 4) tumor spillage has taken place into the abdominal     cavity at the time of surgery or following spontaneous tumor rupture. All study participants     will receive imatinib 400 mg/day orally, but the duration of imatinib administration will be     determined randomly (either for 12 or for 36 months). The study participants will be followed     up using blood tests and computed tomography (or MRI) of the abdomen. The computed tomography     examinations will be performed at 6 month intervals for a median of 5 years. A total of 280     patients will be entered into the study. The study hypothesis is that adjuvant imatinib may     prevent some of the GIST recurrences, and that there may be a difference in the rate of GIST     recurrence between the two groups.   "
173842|NCT00116948|"     The purpose of this study is to compare two total hip replacement systems: Hip Resurfacing     System (ReCap) versus Mallory-Head/Exeter.   "
173843|NCT00116961|"     This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma     remains a non-curable disease however, newer medications and their combinations appear to     provide higher response rates and higher complete response rates than current treatment     options. One of the new medications in multiple myeloma is Velcade. Preliminary results from     a study using a combination of Velcade with Doxil have shown high response rates (disease     reduction). Preliminary results also show that an addition of dexamethasone to Velcade in     patients not responding to Velcade alone showed improved response rates. This study involves     treatment with a new combination of three standard medications: Velcade, Doxil, and     dexamethasone (VDd combination). The proposed combination of all three drugs may improve     efficacy and response.      Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple     myeloma patients who have received at least two prior therapies and have demonstrated disease     progression on the last therapy. Velcade is still currently under investigation for other     indications. Doxil is not approved for use in multiple myeloma but is an approved drug for     use in patients with some other cancers. Several published clinical trials provide evidence     that Doxil is an active agent in multiple myeloma and it is used in treatment combinations     for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple     myeloma, but is not approved by the FDA for that use. The combination of all three drugs is     experimental (not FDA approved).      The goals of this study are to determine if this new combination therapy with Velcade, Doxil     and dexamethasone is an effective treatment and also to determine the side effects that occur     when this combination treatment is given.   "
173844|NCT00116974|"     This research project is a multi-center double-blind, parallel, randomized, controlled     clinical trial design comparing the efficacy of dental scaling and root planing to control     treatment (superficial cleaning) for the prevention of preterm birth in pregnant women with     periodontal disease.   "
173845|NCT00116987|"     Of the 19,000 pacemakers implanted across Canada in 2002, 1/3 of them were for patients 80     years and older. This is the fastest growing segment of our population, yet no study has     specifically been done in this age group to determine the optimal pacing mode.      We wish to determine whether dual chamber or single chamber pacing is associated with a     reduction in emergency room visits or hospitalizations for cardiovascular causes (e.g.,     congestive heart failure (CHF), atrial fibrillation (AF)) resulting in improved quality of     life.   "
173846|NCT00117000|"     The purpose of this study is to determine what effect treatment for one year with     testosterone and a nutritional supplement, alone and combined, has on the adverse effects of     under-nutrition in community-dwelling older men and women.   "
173862|NCT00118209|"     This randomized phase III trial studies rituximab when given together with two different     combination chemotherapy regimens to compare how well they work in treating patients with     diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, may     block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy     work in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Giving rituximab together     with combination chemotherapy may kill more cancer cells. It is not yet known which     combination chemotherapy regimen is more effective when given with rituximab in treating     diffuse large B-cell non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying rituximab when given together with two     different combination chemotherapy regimens to compare how well they work in treating     patients with diffuse large B-cell lymphoma.   "
173925|NCT00119041|"     This study seeks to evaluate and document the processes of outreach consultation through     joint-clinics via teleconferencing as an intervention for system improvement in care delivery     and management of diabetes mellitus (DM) at a Community Based Outpatient Center (CBOCs).   "
173847|NCT00117013|"     Background:      HIF-1 is a common mediator of hypoxic and non-hypoxic pathways that affects a transcriptional     program leading to survival, angiogenesis, migration and invasion of cancer cells. We have     demonstrated that chronic administration of topotecan inhibits HIF-1alpha expression,     angiogenesis and tumor growth in human xenografts. Notably, the mechanism by which topotecan     inhibits HIF-1alpha protein expression is independent of replication-mediated DNA damage,     suggested a mechanism of action distinct from its cytotoxic effects.      Objectives:      This clinical trial is designed to explore the hypothesis that chronic administration of     topotecan (TPT) inhibits Hypoxia Inducible factor 1alpha (HIF-1alpha) expression and     angiogenesis in patients with metastatic tumors over-expressing HIF-1alpha.      Eligibility:      Adult patients with metastatic solid tumors expressing HIF-1alpha, for whom standard therapy     does not exist or would likely not be effective, will be evaluated for study eligibility. Due     to safety concerns, pregnant women and HIV-infected individuals are excluded from this study.     Prior to enrollment, archival tumor tissue wil be evaluated for the expression of HIF-1alpha     as assessed by IHC. Only patients who have tumors that express HIF-1alpha and who meet all     eligibility criteria will be enrolled on this study. Patients will be asked to undergo a     biopsy to evaluate HIF-1alpha expression before starting treatment and at the end of     treatment on cycle 2 (day 12 or 13 cycle 2).      Design:      Topotecan at the dose of 1.2 mg/m(2) will be administered orally daily x 5 for 2 weeks,     during a 28 days cycle. Imaging studies including CT, FDG-PET and DCE-MRI will be performed     at baseline, at the end of treatment on cycle 1 (day 9 or 10), end of treatment on cycle 2     (day 12 or 13) and then every 2 cycles and will provide information on clinical response as     well as tumor metabolism and angiogenesis. The repeat scans on day 9 or 10 of cycle 1 will be     performed solely for research purposes to evaluate for early changes in tumor metabolism and     angiogenesis. Additional correlative studies include evaluation of mRNA expression of HIF-1     target genes in tumor tissue, circulating markers of angiogenesis, and measurement of     circulating endothelial precursor cells (CEP). The goal of this trial is to establish whether     topotecan inhibits HIF-1alpha and angiogenesis in human cancers....   "
173848|NCT00117026|"     The purpose of this study is to determine whether benfotiamine supplementation can reduce     markers of microvascular complications in type 1 diabetic patients.   "
173853|NCT00117091|"     The purpose of this study is to evaluate the percentage of subjects in Australian clinical     practice continuing treatment with Anakinra (Kineret®) at the end of study week 48 in     subjects with active RA. The continued use of Kineret® will be based on pre-defined response     assessment criteria for subjects with active RA.   "
173854|NCT00118092|"     This phase II trial is studying how well 17-AAG works in treating patients with metastatic     prostate cancer that did not respond to previous hormone therapy. Drugs used in chemotherapy,     such as 17-AAG, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing.   "
173855|NCT00118105|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and     oxaliplatin together with bevacizumab before and after surgery may be an effective treatment     for liver metastases.      PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin     together with bevacizumab works in treating patients who are undergoing surgery for liver     metastases due to colorectal cancer.   "
173856|NCT00118131|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin     works in treating patients with stage III or stage IV non-small cell lung cancer.   "
173857|NCT00118144|"     This phase II trial is studying how well bortezomib works in treating patients with stage     IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth.   "
173858|NCT00118157|"     This phase II trial studies how well giving lapatinib ditosylate together with tamoxifen     citrate works in treating patients with breast cancer that has spread from where it started     to nearby tissue or lymph nodes or to other areas of the body and did not respond to previous     treatment with tamoxifen citrate. Lapatinib ditosylate may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast     cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the     use of estrogen by the tumor cells. Sometimes when tamoxifen citrate is given, it does not     stop the growth of tumor cells. The tumor is said to be resistant to tamoxifen citrate.     Giving lapatinib ditosylate together with tamoxifen citrate may reduce drug resistance and     allow the tumor cells to be killed.   "
173859|NCT00118170|"     This phase I trial is studying the side effects and best dose of sorafenib in treating     patients with metastatic or unresectable solid tumors, multiple myeloma, or non-Hodgkin's     lymphoma with or without impaired liver or kidney function. Sorafenib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood     flow to the cancer. Sorafenib may have different effects in patients who have changes in     their liver or kidney function   "
173860|NCT00118183|"     This randomized phase II trial is studying how well giving docetaxel together with either     cetuximab or bortezomib works as first-line therapy in treating patients with stage III or     stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in     different ways. Some find tumor cells and kill them or carry tumor-killing substances to     them. Others interfere with the ability of tumor cells to grow and spread. Bortezomib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     docetaxel together with either cetuximab or bortezomib may be effective as first-line therapy     in treating non-small cell lung cancer.   "
173861|NCT00118196|"     RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer     cells.      PURPOSE: This phase II trial is studying how well giving azacitidine together with arsenic     trioxide works in treating patients with myelodysplastic syndromes or chronic myelomonocytic     leukemia.   "
173876|NCT00118391|"     This study will determine the effectiveness of cognitive behavior therapy (CBT) and     contingency management (CM) in reducing gambling behaviors and other related problems in     pathological gambling.      Study hypothesis: Participants who receive CBT and CM will attend more treatment sessions and     show better outcomes than those who receive CBT alone.   "
173863|NCT00118222|"     RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active     when it is exposed to a certain kind of light. When the drug is active, tumor cells are     killed. Giving photodynamic therapy after surgery may kill any remaining tumor cells.      PURPOSE: This randomized clinical trial is studying two different light doses of photodynamic     therapy using porfimer sodium to compare how well they work in treating patients who are     undergoing surgery for recurrent malignant astrocytoma.   "
173874|NCT00118365|"     This randomized phase III trial is studying eflornithine and sulindac to see how well they     work compared to a placebo in preventing colorectal cancer in patients with colon polyps.     Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming     back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known     whether eflornithine and sulindac are more effective than a placebo in preventing colorectal     cancer   "
173864|NCT00118235|"     This phase II trial is studying how well giving cisplatin and irinotecan together with     bevacizumab works in treating patients with extensive-stage small cell lung cancer. Drugs     used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of small     cell lung cancer by blocking blood flow to the tumor. Giving cisplatin and irinotecan     together with bevacizumab may kill more tumor cells.   "
173865|NCT00118248|"     This phase II trial is studying how well tanespimycin works in treating patients with     inoperable locoregionally advanced or metastatic thyroid cancer. Drugs used in chemotherapy,     such as tanespimycin, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing.   "
173866|NCT00118261|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Erlotinib may help chemotherapy work better by making tumor cells more sensitive to the     drugs. Giving erlotinib together with combination chemotherapy and bevacizumab may kill more     tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when     given together with combination chemotherapy and bevacizumab as first-line therapy in     treating patients with metastatic colorectal cancer.   "
173868|NCT00118287|"     This phase I/II trial studies how well giving azacitidine together with etanercept works in     treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as     azacitidine, works in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may     protect normal cells from the side effects of chemotherapy   "
173869|NCT00118300|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells.     Internal radiation uses radioactive material placed directly into or near a tumor to kill     tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when     given together with radiation therapy in treating patients with locally advanced cervical     cancer or other pelvic cancer.   "
173870|NCT00118313|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system     in different ways and stop tumor cells from growing. Giving vaccine therapy together with     imiquimod after surgery may help the body kill any remaining tumor cells.      PURPOSE: This randomized phase I trial is studying the side effects and best way to give     vaccine therapy with or without imiquimod in treating patients who have undergone surgery for     stage II, stage III, or stage IV melanoma.   "
173871|NCT00118326|"     RATIONALE: A bone marrow transplant from a brother or sister may be able to replace     blood-forming cells that were destroyed by chemotherapy or radiation therapy.     Colony-stimulating factors, such as G-CSF, cause the body to make blood cells. Giving G-CSF     to the donor may help the body make more stem cells that can be collected for bone marrow     transplant and may cause fewer side effects in the patient after the transplant.      PURPOSE: This phase I/II trial is studying the side effects of donor bone marrow transplant     and to see how well it works in treating young patients with cancer or a non-cancerous     disease.   "
173872|NCT00118339|"     RATIONALE: Chemoprotective agents may protect normal cells from the side effects of     chemotherapy. Ice chips or saline mouth rinse may lessen the severity or help prevent     symptoms of mucositis or mouth sores in patients receiving melphalan and autologous stem cell     transplant for multiple myeloma. It is not yet known whether ice chips are more effective     than saline mouth rinse in reducing or preventing mucositis.      PURPOSE: This randomized phase III trial is studying ice chips to see how well they work     compared to saline mouth rinse in reducing or preventing mucositis in patients receiving     melphalan and autologous stem cell transplant for multiple myeloma.   "
173873|NCT00118352|"     This phase II trial is studying the side effects and best dose of alemtuzumab when given     together with fludarabine phosphate and total-body irradiation followed by cyclosporine and     mycophenolate mofetil in treating patients who are undergoing a donor stem cell transplant     for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, a     monoclonal antibody, such as alemtuzumab, and radiation therapy before a donor stem cell     transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy     before or after transplant also stops the patient's immune system from rejecting the donor's     bone marrow stem cells. The donated stem cells may replace the patient's immune cells and     help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from     happening.   "
173881|NCT00118456|"     AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with     potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has     an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will     assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity     of AEE788 in advanced cancers.   "
173882|NCT00118469|"     This study will determine the effectiveness of adding a parent-involved intervention to     cognitive behavior therapy in reducing depressive symptoms among Latino adolescents with     depression.   "
173883|NCT00118482|"     The main question in the study is whether people taking fludrocortisone are less likely to     faint than people taking an inactive pill called a placebo.      Fludrocortisone is a drug that stimulates the body to retain salt and water. The     investigators know from some studies that it might prevent people from fainting at home and     in the community, while they are carrying on with their lives. There is some evidence that     salt and water retention help prevent fainting, but no one has a clear idea about whether     this is true. This study will try to determine if that is true.   "
173884|NCT00118495|"     The objective of this study is to evaluate the clinical efficacy and safety of Zestra(TM) in     women with acquired mixed desire/interest/arousal/orgasm disorders under conditions of home     usage. The primary efficacy hypothesis will compare the effect of Zestra versus placebo on     the incidence of successful and satisfactory sexual encounters.   "
173885|NCT00118508|"     The purpose of this study is to evaluate the effectiveness of once weekly risedronate in the     prevention and treatment of bone loss in premenopausal and newly menopausal women with breast     cancer who have received chemotherapy.      The hypothesis is that bisphosphonate therapy will prevent bone loss at clinically relevant     sites, such as the hip and spine. The investigators also hypothesize that there will be a     correlation between biochemical markers of bone turnover and changes in bone mineral density.   "
173886|NCT00118521|"     Musculoskeletal conditions account for the third leading cause of health systems expenditure     in Australia. Patellofemoral pain syndrome or pain about the knee cap is such a condition     often treated in primary care. Both the individual and community are affected by this     condition with an estimated 1 in 4 sufferers having problems and pain up to 20 years after     first being afflicted. Importantly, it interferes with activities such as walking, jogging,     gym classes and aerobics, which are often prescribed to prevent serious conditions of the     heart, diabetes and obesity. Hence, it negatively impacts the health and well being of our     nation.      Two popular treatment options that are commonly prescribed for the management of     patellofemoral pain syndrome are physiotherapy and foot orthotics. To date, there is some     evidence supporting physiotherapy, especially current best practice methods, such as a     combined program of therapeutic exercise, manual therapy and kneecap taping. There is a lack     of evidence for the use of orthotics in treating patellofemoral pain syndrome.      This project will conduct a randomised clinical trial to evaluate the relative benefits of     orthotics as the sole treatment of patellofemoral pain syndrome and also when combined with     physiotherapy. Factors associated with predicting the results of orthotic therapy will be     studied to see if there are any tests that a health care practitioner can perform to provide     information early on in a consultation regarding possible treatment outcomes. A cost-benefit     analysis will also be conducted to calculate the relative economic merits of the treatments.      A tangible outcome of this project will be the development of clinical guidelines for the     most effective method of treating patellofemoral pain syndrome in primary health care.   "
173887|NCT00118534|"     The primary study objective is to conduct a prospective, randomized controlled clinical trial     that compares the effectiveness of two approaches for delivering smoking cessation treatment     for veterans with posttraumatic stress disorder (PTSD). An approach where smoking cessation     treatment is integrated into mental health care for PTSD and delivered by mental health     providers (experimental condition) will be compared to specialized smoking cessation clinic     referral (VA's usual standard of care).      Secondary study objectives are to (a) compare the cost outcomes and cost-effectiveness of IC     versus USC, (b) identify treatment process variables that explain (mediate) observed     differences in smoking abstinence rates for the two study conditions, and (c) determine     whether cessation from smoking is associated with worsening of symptoms of PTSD and/or     depression.   "
173888|NCT00118547|"     The purpose of this pilot trial is to provide preliminary evidence of the effectiveness of a     brief behavioral intervention using telemedicine home monitoring to help individuals with     multiple sclerosis adhere to medications that slow disease progression.   "
173889|NCT00118560|"     The purposes of this pilot project are to (a) determine changes in calf muscle blood flow and     energy supply resulting from calf muscle exercise, and (b) to determine changes in these     variables resulting from exercise training (walking and calf muscle exercise). This is a     pilot study to prepare for a larger project in the future. Exercise and exercise training     should increase blood flow and energy supply to the calf muscles.   "
173890|NCT00118573|"     Objective of the present study is to compare endovascular repair versus surveillance and,     eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with     respect to patient survival, AAA rupture and AAA related death risks.   "
173900|NCT00118716|"     During this study, your child will need to attend up to 5 office visits and maintain regular     telephone contact with the clinic. Certain office visits will include physical exams, medical     history review, exercise challenge test (walking/running on a treadmill), electrocardiogram     (ECG) tests, and lung function tests. All study related medications and medical examinations     are provided at no cost. All study drugs are currently available by prescription to patients     4 years and older.   "
173901|NCT00118729|"     Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following     allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of     allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly     referred to as hay fever, it is characterized by sneezing, nasal congestion and pruritus,     rhinorrhea, and pruritic, watery, red eyes. The purpose of this study is to evaluate the     onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus     vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed     following a single dose of treatment in controlled pollen concentrations in an allergen     challenge chamber.   "
173891|NCT00118586|"     This study will look for abnormalities in a brain of persons affected with spasmodic     dysphonia, a form of movement disorder that involves involuntary spasms of the muscles in     the vocal folds causing breaks of speech and affecting voice quality. The causes of this     disorder are not known. The study will compare results of magnetic resonance imaging (MRI) in     people with spasmodic dysphonia and in healthy volunteers.      People with adductor or abductor spasmodic dysphonia and healthy volunteers may be eligible     for this study. Candidates are screened with a medical history, physical examination, and a     test called nasolaryngoscopy. For this test, the inside of the subject's nose is sprayed with     a decongestant, and a small, flexible tube called a nasolaryngoscope is passed through the     nose to the back of the throat to allow examination of the larynx (voice box). During this     procedure, the subject is asked to perform tasks such as talking, singing, whistling, and     saying prolonged vowels. The nasolaryngoscope is connected to a camera to record the     movements of the vocal folds during these tasks.      Eligible participants then undergo MRI of the brain. MRI uses a strong magnetic field and     radio waves instead of x-rays to obtain images of body organs and tissues. For this test, the     subject lies on a table that slides into the MRI scanner, a narrow metal cylinder, wearing     ear plugs to muffle loud knocking sound that occurs during the scan. During MRI anatomical     images of the brain are obtained. Subject may be asked to participate in up to two scanning     sessions. Each session takes about 1-1/2 hours.      Participants may also be asked to volunteer for a brain donation program which is optional.     Information gained from donated tissue may lead to better treatments and potential cures for     spasmodic dysphonia.   "
173892|NCT00118612|"     Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities     of an allergen extract to an allergic patient, is a curative approach which directly treats     the underlying allergic disease. Tree MATA MPL has been developed to provide pre-seasonal     specific immunotherapy for patients with an allergy to tree pollen (hay fever).      The purpose of this double-blind Phase IIb study is to assess the tolerability and     immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and     alder pollen.   "
173893|NCT00118625|"     Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities     of an allergen extract to an allergic patient, is a curative approach which directly treats     the underlying allergic disease. Tree MATA MPL has been developed to provide pre-seasonal     specific immunotherapy for patients with an allergy to tree pollen (hay fever).      The tolerability and immunogenicity of Tree MATA (allergen modified with glutaraldehyde and     adsorbed to tyrosine) with and without MPL adjuvant (monophosphoryl lipid A, extracted from a     bacterial cell surface) is being investigated in this double-blind, randomized Phase IIa     study in volunteers allergic to birch and hazel and alder pollen.      Additionally, this study will assess residual allergenicity of the modified birch and hazel     and alder pollen in the product Tree MATA MPL using skin prick testing in volunteers allergic     to birch and hazel and alder pollen.   "
173894|NCT00118638|"     The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every     3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered     as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid     malignancies.   "
173895|NCT00118651|"     This was a study involving the emergency department and outpatient clinics of the David Grant     United States Air Force (USAF) Medical Center, a tertiary care facility. Patients 18 years of     age or older with acute respiratory tract symptoms and positive chest radiographs from     October 1, 2004 through May 31, 2005 were included as positive cases. Controls were randomly     selected from a review of negative chest radiograph reports with a clinical history of an     acute respiratory illness over the same time period. Equivocal radiographs were treated as     positive cases. Patients were excluded if they were under the age of 18 or in suspected cases     of hospital-acquired or aspiration pneumonia.      The six clinical indicators included cough, sputum production, temperature, heart rate,     respiratory rate, and findings on physical examination. Abnormal vital signs were defined as     temperature of 100.5 degrees Fahrenheit (38 degrees Celsius) or greater, heart rate greater     than or equal to 100 beats per minute, and respiratory rate greater than 20 breaths per     minute. Positive physical examination findings consisted of the presence of crackles,     decreased breath sounds, dullness to percussion, egophony, or rhonchi.   "
173896|NCT00118664|"     The purpose of this study is to learn how blood clotting substances respond in children with     septic shock, low platelet counts, and multiple organ failure (MOF) treated at different     institutions.      Multiple organ failure can be related to an infection producing septic shock, in which     substances released in the blood cause poor blood flow to the organs. The number of platelets     circulating in your child's blood stream is also decreased (this is called     thrombocytopenia) as a result of this condition. Research has shown that certain substances     in the part of the blood known as plasma (the clear liquid part of the blood not including     the red blood cells but holding blood clotting factors) can cause the organs to work poorly.     The investigators would like to compare these blood responses in children with this     condition, receiving a variety of different treatments, for multiple organ failure in other     medical centers around the world. The investigators hope to enroll 80 patients into the     study.   "
173897|NCT00118677|"     This trial is aimed at studying the safety of long term supervised treatment interruption in     HIV infected patients with CD4 over 350/mm3 and plasma HIV RNA under 50 000/mL. Another aim     of this study is to assess the immunological and virological factors associated with the     duration of treatment interruption.   "
173898|NCT00118690|"     During this study, your child will need to attend up to 5 office visits and maintain regular     telephone contact with the clinic. Certain office visits will include physical exams, medical     history review, exercise challenge test (walking/running on a treadmill), electrocardiogram     (ECG) tests, and lung function tests. All study related medications and medical examinations     are provided at no cost. All study drugs are currently available by prescription to patients     4 years and older.   "
173899|NCT00118703|"     The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg     once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent     subjects (12 years of age and older) with vasomotor rhinitis (VMR).   "
174017|NCT00120341|"     The purpose of this research study is to determine if the use of a series of the Anodyne     Therapy System in-home treatments over a 90-day period will improve peripheral sensation and     quality of life in persons with diabetes mellitus.   "
173902|NCT00118742|"     This two-arm study will assess the efficacy and safety of a long-term calcineurin     inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an     orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g     twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The     anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500     individuals.   "
173903|NCT00118755|"     This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral     Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a     first-line treatment in patients with locally advanced or metastatic colorectal cancer.     Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid)     on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each     3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1     and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment     was 1-2 years, and the target sample size was 100-500 individuals.   "
173904|NCT00118768|"     This Phase II study is being conducted in treatment-naive patients (no previous antiviral     therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety     and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug     approved by the Food and Drug Administration for the treatment of Hepatitis C infection).   "
173905|NCT00118781|"     This is a multinational, double-blind, placebo-controlled trial designed to assess whether     iseganan, applied topically to the oral cavity, can prevent ventilator-associated pneumonia     among patients who are intubated and mechanically ventilated and survive for up to 14 days.   "
173906|NCT00118794|"     Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with     glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic     effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent     to which the risks associated with the use of the drug in settings without G6PD screening     might outweigh the benefits to malaria treatment. The investigators will evaluate, in     operational settings, the safety and effectiveness of Lapdap and coartemether     (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10     years of age.   "
173907|NCT00118807|"     The purpose of this trial is to compare the effectiveness of three combination treatments for     uncomplicated malaria when given in operational settings, without supervision of doses other     than the first dose.   "
173908|NCT00118820|"     Despite over 50 years of antibiotic use and multiple clinical investigations (>50), no     definitive studies exist to confirm or refute the use of systemic antibiotics to prevent     postoperative inflammatory complications after third molar (M3), aka wisdom teeth removal.     Among patients having M3s extracted, does the administration of systemic prophylactic     antibiotics when compared to placebo, decrease the rate of postoperative inflammatory     complications? The first specific aim of the study is to implement a randomized,     placebo-controlled clinical trial to determine if systemic prophylactic antibiotics, when     compared to placebo, decrease the rate of postoperative alveolar osteitis (AO) after M3     extraction. For this proposal, postoperative AO is the primary outcome variable.      The second specific aim is to implement a pilot study using a randomized, placebo-controlled     clinical trial to determine if systemic prophylactic antibiotics, when compared to placebo,     decrease the rate of postoperative infection after M3 extraction. For the purposes of this     proposal, postoperative infection is a secondary outcome variable. Based on sample size     estimates, we believe it will be necessary to implement a multi-year trial to address the     second specific aim definitively. As such, we will use the experience and preliminary results     derived from this clinical trial to develop and implement a future large scale clinical     trial.      The third specific aim is to identify risk factors associated with postoperative inflammatory     complications in order to develop a model to predict if the prophylactic administration of     antibiotics will prevent the postoperative inflammatory complications of alveolar osteitis     and infection following the removal of M3's.      The long-term goal of this project is to provide compelling clinical evidence to support     recommendations regarding the use of systemic antibiotics in this setting and alter clinical     practice based on the results of a well-done, definitive clinical investigation.   "
173909|NCT00118833|"     This study will determine whether the herbal product St. John's wort is safe and effective in     treating generalized social anxiety disorder (GSAD).      Study hypothesis: Hypericum perforatum (St. John's wort) is more effective in treating GSAD     than placebo.   "
173910|NCT00118846|"     The purpose of this study is to determine whether soy supplements can reduce hardening of the     arteries in postmenopausal women. This study will also determine the effects of soy     supplements on mental processes, bone mineral density, and breast tissue density.   "
173911|NCT00118859|"     This pilot study will determine the feasibility of enrolling participants from different     populations for a larger study of low back pain (LBP) treatment. In addition, this study will     assess the effectiveness of data collection instruments and procedures as well as utilize     feedback from participants to refine a future study.   "
173912|NCT00118872|"     This study will determine whether lactobacillus GG (LGG), a beneficial bacterium, when given     in yogurt, will reduce growth faltering in babies living in a poor area of Pakistan who are     being weaned from breastfeeding.      Study hypothesis: Use of the probiotic bacteria LGG at the time of weaning will lessen the     impact of faltering growth in babies living in the slums of Pakistan.   "
173913|NCT00118885|"     The purpose of this trial is to evaluate the effects of Tai Chi Chih versus Health Education     on shingles immunity in older adults as measured by unstimulated and vaccine-stimulated     responses. The secondary goal of the study is to determine the effects of Tai Chi Chih versus     Health Education on measures of health functioning, depressive symptoms, and health behaviors     in the elderly.   "
174018|NCT00120354|"     This study will evaluate the long-term safety and effectiveness of lamivudine therapy and the     possibility of stopping therapy in patients whose hepatitis B is chronic, that is, long     lasting, and which has responded to treatment. Chronic hepatitis B, caused by a virus, is a     common form of liver disease affecting about 1 million Americans and about 5 percent of the     world's population. Health effects include a continuous state of being infectious and the     risk of transmitting hepatitis to other people, symptoms of liver disease, and development of     cirrhosis-that is, severe damage to the liver-and liver cancer. Lamivudine is a medication     that blocks hepatitis B effectively but does not make it disappear completely. Scientists     believe that the immune system must also be active to rid the body of the last traces of     hepatitis B.      Patients ages 18 and older who have chronic hepatitis B and are being treated with lamivudine     may be eligible to participate in this study. They will undergo a medical history and     physical examination and will be given lamivudine in 100 mg tablets to be taken as one     tablet, once each day. Patients will be asked to return to the outpatient clinic every 3     months, when they will undergo a brief interview and measurement of vital signs-such as blood     pressure, pulse, and body weight. During the visits, they will fill out questionnaires about     any symptoms or side effects they have, and they will be seen by a doctor and have a brief     medical history and examination. There will be a collection of blood for complete blood     counts, liver enzymes, and hepatitis B virus. Extra blood tests may be done to analyze     patients' immune reactions to hepatitis B. Patients will also receive refills of their     lamivudine tablets. They will continue to be treated with lamivudine as long as it seems to     control the hepatitis infection and liver disease.      At intervals of about 1 year, patients will have ultrasound examinations, lasting about 1     hour, of the liver and abdomen. Then at intervals of about 5 years, patients will undergo     liver biopsies, which require a hospital stay of 2 to 3 days. A liver biopsy is done by     passing a needle through the skin into the liver to obtain a piece of liver about 2 inches     long and 1/16-inch in diameter. A small amount of bleeding probably occurs with most liver     biopsies. Internal bleeding is a risk, which may require that the patient stay in the     hospital a few days longer, for rest, observation and pain medicine. The biopsy provides     information that proves whether lamivudine is controlling the liver disease and preventing it     from worsening or progressing to cirrhosis.      Side effects of lamivudine include fatigue, muscle aches, fever and chills, sore throat,     nausea, stomach pain or cramps, and diarrhea. Serious side effects are rare, occurring in     less than 1% of people taking lamivudine. They include inflammation of the pancreas, nerve     damage, and buildup of lactic acid in the blood. About 25% of patients experience a temporary     worsening, or flare, of hepatitis during the first few months of treatment. If flares are     severe, it is important for researchers to determine whether they are caused by resistance to     lamivudine or by the immune system acting against the hepatitis B virus or another liver     condition. A flare of hepatitis can also occur when lamivudine is stopped, that is, a     withdrawal. In such situations, testing for hepatitis B virus levels and other liver     conditions is important. It may lead to other treatments or stopping lamivudine and taking     another medication instead. While patients are participating in the study, they will have a     careful evaluation of their hepatitis and general condition. They may have an improvement in     their disease as a result of long-term lamivudine therapy.   "
180661|NCT00210626|"     The purpose of this trial is to evaluate the physical function outcomes in anemic, critically     ill, trauma subjects treated with epoetin alfa (PROCRIT®) compared to placebo.   "
173914|NCT00118898|"     Currently, the preferred anti-HIV regimens used in the United States consist of two     nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse     transcriptase inhibitor (NNRTI) efavirenz (EFV). However, with new anti-HIV drugs being     approved, alternative regimens need to be tested to determine if new drug combinations have     increased effectiveness in treating HIV. The purpose of this study is to test the safety,     tolerability, and effectiveness of four different regimens in HIV-infected adults who have     never taken anti-HIV drugs.   "
173915|NCT00118911|"     This study will determine the efficacy of cognitive behavioral therapy in treating adults     with attention deficit hyperactivity disorder.   "
173916|NCT00118924|"     Tick-borne encephalitis (TBE) is a viral illness common in the Northern Hemisphere,     especially Europe and Asia. TBE infection may lead to central nervous system problems and     death. The purpose of this study is to test the safety of and immune response to a TBE     vaccine in healthy adults. The vaccine is related to a live attenuated virus developed     against dengue virus infection.   "
173917|NCT00118937|"     Ninety percent of patients with type-1-diabetes will develop late-diabetic complications in     the eyes, kidneys, nervous- or cardiovascular-system. Poor glycaemic control is an important     risk-factor for development of these late-diabetic complications. The Diabetes Control and     Complications Trial (DCCT)-study showed, that improved glycaemic control can prevent the     development and progression of these late-diabetic complications. Until now treatment with     insulin- and diet-therapy has been the only treatment-modalities available to improve the     glycaemic control in patients with type-1-diabetes. A substantial number of these patients     still have long-standing poor glycaemic control despite intensive treatment with insulin- and     diet-therapy.      The antidiabetic drug metformin has shown to be able to improve the glycaemic control in     combination with insulin and furthermore reduce both mortality and the risk of developing     cardiovascular disease in patients with type-2-diabetes.      Only few small studies have investigated the effect of treatment with metformin in patients     with type-1-diabetes. These studies have suggested a positive effect of metformin in these     patients too.      Method:      100 patients with type-1-diabetes with persistent poor glycaemic control i.e. HbA1c > 8.5%     during the last 12 months are eligible. Patients are treated for one month with placebo.     Hereafter half of the patients will be treated with metformin and the other half continues     with placebo for 12 months both as add-on therapy. All patients are continuing ongoing     treatment with insulin throughout the study. Before and after the start of treatment with     metformin the effect on glycaemic control and other known risk-factors for development of     cardiovascular disease i. e. blood-pressure, fasting lipids, urine-albumine-excretion,     endothelial dysfunction, inflammation, fibrinolysis etc. is assessed.      This study will show if treatment with metformin can improve the glycaemic control and hereby     the prognosis of patients with type-1-diabetes with persistent poor glycaemic control despite     intensive treatment with insulin- and diet-therapy. This group of patients suffers the     highest risk of developing late-diabetic complications with reduced quality of life and     life-expectancy as a consequence.   "
173918|NCT00118950|"     Background: Metformin is the first drug of choice in obese patients with type-2 diabetes     (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In     non-obese T2DM patients insulin-secretagogues are empirically used as first choice. The aim     of this study was to evaluate the effect of metformin versus an insulin-secretagogue,     repaglinide on glycaemic regulation and non-glycaemic cardiovascular risk markers in     non-obese patients with T2DM.      Methods: Single-center, randomised, double-masked, double-dummy, cross-over-study of 96     non-obese (BMI ≤ 27 kg/m2) Caucasian T2DM-patients. After a one month run-in on diet-only     treatment, patients were randomised to either repaglinide 2mg three times a day (t.i.d).     followed by metformin 1g twice a day (b.i.d.) or vice versa each for a period of four months     with a one month wash-out between interventions.   "
173919|NCT00118963|"     Aim:      The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular     events in obese patients with type-2-diabetes treated with metformin compared with other     hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese     patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when     diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of     cardiovascular events, the use of metformin for this sub-group of patients might be more     beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents     (OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence     exist for choosing the optimal class of OHA to be combined with insulin. The aim of the     project is therefore to investigate the effect of metformin vs. an insulin-secretagogue     (repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular     risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone.      Methodology:      Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese     (BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment     with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart     30/70, BIAsp30) for a period of 12 months.   "
173920|NCT00118976|"     The primary aim is to evaluate the anti proteinuric effect of increasing doses of the ACE     inhibitor, lisinopril: 20, 40 and 60 mg daily in type 1 diabetic patients with hypertension     and diabetic nephropathy.      The secondary aim is to evaluate the effect on blood pressure (24 hour ambulatory blood     pressure) and kidney function (glomerular filtration rate (GFR)).      The tertiary aim is to evaluate differences in response to treatment according to     ACE/insertion/deletion (ID)-genotypes and other genetic variants in the genes of the renin     angiotensin system.   "
173921|NCT00118989|"     Specific Aims:        -  To determine if curcuminoids modulate cellular proliferation as measured by          proliferating cell nuclear antigen (PCNA) in the colorectal mucosa of subjects with          previously resected adenomatous colonic polyps.      Hypothesis: Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects     with previously resected sporadic adenomatous colonic polyps.        -  To determine if curcuminoids modulate apoptosis, as measured by TUNEL assay, in the          colorectal mucosa of subjects with previously resected adenomatous colonic polyps.      Hypothesis: Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously     resected sporadic adenomatous colonic polyps.        -  To determine if curcuminoids modulate COX-2 expression as measured by          immunohistochemical assays in subjects with previously resected adenomatous colonic          polyps      Hypothesis: Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with     previously resected sporadic adenomatous colonic polyps.        -  To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids      Hypothesis: Curcuminoids decrease concentrations of urinary eicosanoids.   "
173922|NCT00119002|"     This study will compare a single dose of oral dexamethasone to placebo in a multicenter,     randomized, double blind trial of infants aged 2 to 12 months with first-time bronchiolitis     (defined as wheezing within 7 days of onset). This is given as additional therapy beyond any     other routine therapy used at that center. No current standard therapy is withheld, and no     additional tests or other treatments are part of the study.The primary hypothesis is that     dexamethasone will be more effective than placebo in preventing hospital admission. The     secondary hypotheses are that dexamethasone will decrease respiratory scores and possibly the     duration of the disease when compared to placebo, and that dexamethasone will be as safe and     as well tolerated as placebo.   "
173923|NCT00119015|"     Some people with nasal allergy symptoms continue to have symptoms even after treatment with a     nasal steroid spray. The purpose of this study is to see if these patients are helped by     adding another medication (montelukast) to their treatment compared to placebo (a substance     that looks like the active medication but does not contain the drug).   "
173924|NCT00119028|"     Based on the published evidence, collaborative care for depression is both necessary and     sufficient for improving care and outcomes for depressed patients in primary care settings.     The Translating Initiatives in Depression into Effective Solutions (TIDES) project, upon     which ReTIDES is based, developed a VA-adapted version of collaborative care through input     from veterans, clinicians, and managers. The initial TIDES project resulted in a clinically     stable and effective model as tested in seven primary care practices in three VISNs. This     positive result provided the basis for spreading and sustaining the TIDES model and     initiating the study of national implementation strategies and issues.   "
173926|NCT00119054|"     Patients treated at Veterans Affairs (VA) medical centers are older and have multiple chronic     conditions. Two of the most common conditions in the VA population are hypertension (HTN) and     Type 2 diabetes (DM). Unfortunately, DM and HTN have few perceptible symptoms on a daily     basis that motivate patients to comply with treatment recommendations and lifestyle changes.     Thus, serious complications and long-term adverse outcomes are common in both of these     conditions.      Home telehealth is a general term used to describe the delivery of health care services to     the patient's home using audio, video, or other telecommunications technologies. Although     home telehealth offers a number of theoretical advantages, few well-designed controlled     clinical trials have been conducted to establish efficacy and cost benefit. Furthermore,     projects to date have focused on special populations, e.g., heart failure or mental     illnesses. Since home telehealth may hold the most promise for individuals dealing with     multiple chronic illnesses, there is a need for population-based studies addressing the needs     of patients in primary care settings.      Care coordination, as defined by the VHA Office of Care Coordination, is a process of     assessment and ongoing monitoring of patients using home telehealth to proactively enable     prevention, investigation, and treatment that enhances the health of patients and prevents     unnecessary and inappropriate use of resources. Care coordination embeds technology into a     care management process. This results in the right care, at the right time, in the right     place.   "
173927|NCT00119067|"     Anthrax Clinical Trial Objectives:      To assess whether:        -  Anthrax vaccine (AVA or BioThrax, BioPort Corp. Lansing MI) administered by the          intramuscular (IM) route elicits antibody responses that are not inferior (i.e.,          non-inferior) to that achieved by the currently licensed schedule.        -  BioThrax administered by the IM route and containing fewer numbers of doses elicits          antibody responses that are not inferior (i.e., non-inferior) to that achieved by the          currently licensed schedule.        -  Differences in reactogenicity exist between the IM and subcutaneous (SQ) administration          of BioThrax.      Additionally for the final report we will assess whether:        -  Occurrence of adverse events following AVA administration is influenced by selected risk          factors.   "
173928|NCT00119080|"     The purpose of this study is to determine whether the new meningococcal conjugate vaccine     (MCV4) can reduce asymptomatic carriage of meningococcal bacteria, and thus decrease the     transmission of these bacteria in the population.   "
173929|NCT00119093|"     The Home-based AIDS care program pilot project delivers and monitors antiretroviral (ARV) and     tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of     Uganda. This study is evaluating how well this program reduces illness and prolongs the life     of participants, changes sexual behavior, influences levels of adherence to medication,     affects aspects of perceived stigma by participants and their communities, and other     operational components of the program including cost-effectiveness. This study is evaluating     the hypothesis that frequent home visits by a trained lay person with a standard     questionnaire is equivalent in terms of health outcomes to frequent viral load and CD4 cell     count measurements.   "
173930|NCT00119106|"     The primary goals of this study are to assess the safety and efficacy of daily tenofovir to     prevent parenteral HIV infection among injection drug users (IDUs). Assessment of changes in     HIV associated risk behaviors, adherence to study drug, and, among IDU who become     HIV-infected during the trial, evaluation of HIV viral load set point, CD4 counts, genetic     characterization of infecting HIV viruses, and antiretroviral resistance will also be done.   "
173931|NCT00119119|"     The fibrosis of liver is a complication of chronic hepatitis C. There is actually no     established treatment for fibrosis of the liver. Pentoxyphilline and tocopherol may have an     activity on fibrosis. The aim of the study is to analyse the efficacy and the safety of the     combination with pentoxyphilline and tocopherol (12 months) on liver fibrosis, in patients     with chronic hepatitis C, who are non-long-term responders, or with intolerance or     contra-indication to interferon-alfa and ribavirin.   "
173932|NCT00119132|"     Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach     to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this     approach can be very effective. Although the results of these studies suggest that IPTc with     sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe     intervention for reducing the burden of malaria and anaemia in children in high transmission     areas with short transmission periods, there is no data from areas with long transmission     periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and     malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred     forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to     receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or     bimonthly), SP or placebo. The children will also be followed to determine if there is any     rebound in the incidence of severe malaria and anaemia in the year following IPTc.   "
174070|NCT00112580|"     RATIONALE: Biological therapies, such as MDX-010, may stimulate the immune system in     different ways and stop tumor cells from growing.      PURPOSE: This phase II trial is studying how well MDX-010 works in treating patients with     stage IV pancreatic cancer that cannot be removed by surgery.   "
173944|NCT00119340|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy     before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the     patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune system and help destroy any remaining cancer cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving cyclosporine and mycophenolate     mofetil after transplant may stop this from happening.      PURPOSE: This phase I/II trial is studying the side effects and best dose of fludarabine,     total-body irradiation, and donor stem cell transplant followed by cyclosporine and     mycophenolate mofetil and to see how well they work in treating patients with chronic     myelogenous leukemia.   "
173991|NCT00119990|"     During peritoneal dialysis, water is removed from the body. This sometimes occurs at rates of     up to 500 ml/h. During shifts with dialysate with high glucose content, an increase in blood     pressure has been described. The effect upon central hemodynamics is unknown. The researchers     are investigating the effects of low and high glucose dialysate and icodextrin on cardiac     output, stroke volume, pulse rate and blood pressure. The researchers have hypothesized that     the effects seen are induced by vasopressin.   "
173933|NCT00119145|"     Case management is one of the key strategies for malaria control in most endemic countries.     Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial     drugs such as chloroquine, amodiaquine, and sulfadoxine-pyrimethamine (SP). Thus the safety     and efficacy of new anti-malarial drugs need to be tested in sites with well-characterised     malariometric indices in order to make appropriate treatment policies.      Artemisinin-based combination chemotherapies have been documented to consistently produce     faster relief of clinical symptoms and parasite clearance in uncomplicated falciparum malaria     than any other currently used antimalarial drugs. So far, artesunate-amodiaquine (AS-AQ) and     artemether-lumefantrine (AR-LM) are the only two registered fixed-dose artemisinin     combination chemotherapies produced at industrial scale, with good manufacturing practices     and already used in Africa. Several African countries, including Ghana, are therefore     introducing either AS-AQ or AR-LM as first-line antimalarials or evaluating the case for such     a change. Clearly, a direct comparison of both the safety and efficacy profiles of the two     combinations under different epidemiological conditions is urgently needed to guide informed     decisions on the most appropriate antimalarial first-line treatment regimen.      This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination     therapy, artemether-lumefantrine, and artesunate-lapdap in an open-labelled, randomised,     non-inferiority drug trial.      The study results will inform future decisions on first- and second-line treatments for     uncomplicated P. falciparum malaria with respect to efficacy and safety in Ghana.   "
173934|NCT00119158|"     Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is     to treat acute flares using topical medications. The two most common classes of topical     medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin     inhibitors.      Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there     may be a synergistic effect of the combination therapy. Therefore, a combination therapy may     provide a faster resolution of severe skin lesions and consequently reduce the duration of     the topical corticosteroid treatment. Another benefit of the combination therapy maybe the     use of a lower potency corticosteroid to achieve the same degree of clearance.      The hypothesis of this trial is that the combination of the two agents will lead to faster     clearance than the single agent of topical corticosteroids.   "
173935|NCT00119171|"     The purpose of this study is to determine the dose regimen of Ispinesib in combination with     capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion     every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest     period. A patient may continue to receive treatment as long as they are benefiting from the     treatment. Blood samples will be taken at specific times to measure the amount of both drugs     in your body at specific times after the drug is given. Blood samples will also be taken for     lab tests such as complete blood counts and clinical chemistries. Physical exams will be     performed before each treatment with Ispinesib. During the treatment phase, the patients will     undergo regular assessments for safety and clinical response.   "
173936|NCT00119184|"     The purpose of this study is to examine whether spinal anesthesia affects the chances of     successful external cephalic version (ECV) of a breech presenting fetus.      Two study groups will be included; one will receive spinal anesthesia, the other will not.     The non-spinal group will be permitted to cross over if ECV procedure is painful.      The main outcome is success of ECV.   "
173937|NCT00119197|"     The purpose of the study is to confirm the safety and immunogenicity of the oral killed     bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal,     India.   "
173938|NCT00119210|"     The purpose of this small preliminary study is to determine whether it is feasible to recruit     women smokers who have just delivered a baby and are not breastfeeding into a study that     would test whether starting bupropion, a smoking cessation medication, after a baby's birth     helps a postpartum woman to stop smoking.   "
173939|NCT00119236|"     This phase I trial is studying the side effects and best dose of 17-AAG and irinotecan in     treating patients with locally advanced or metastatic solid tumors. Drugs used in     chemotherapy, such as 17-AAG and irinotecan, work in different ways to stop the growth of     tumor cells either by killing the cells or by stopping them from dividing. Giving more than     one drug (combination chemotherapy) may kill more tumor cells.   "
173940|NCT00119249|"     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. This phase II trial is studying how well     sorafenib works in treating patients with stage III or stage IV melanoma that cannot be     removed by surgery   "
173941|NCT00119262|"     This phase II trial is studying how well giving bevacizumab together with combination     chemotherapy works in treating patients who have undergone surgery for breast cancer that has     spread to the lymph nodes. Monoclonal antibodies, such as bevacizumab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may     also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving bevacizumab together with more than one     chemotherapy drug (combination chemotherapy), may be a better way to block tumor growth.   "
173942|NCT00119301|"     RATIONALE: Drugs used in chemotherapy, such as methotrexate, trimetrexate glucuronate, and     leucovorin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of trimetrexate     glucuronate when given together with methotrexate and leucovorin in treating patients with     refractory or recurrent osteosarcoma.   "
173943|NCT00119314|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, docetaxel, and capecitabine, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel     and capecitabine works in treating patients with cancer of unknown primary origin.   "
180662|NCT00210639|"     The purpose of this study is to assess the long-term safety of levofloxacin administered to     children as therapy for acute bacterial infection.   "
173945|NCT00119366|"     This phase II trial studies the side effects and best dose of iodine I 131 monoclonal     antibody BC8 when given together with fludarabine phosphate, total-body irradiation, and     donor stem cell transplant followed by cyclosporine and mycophenolate mofetil in treating     patients with acute myeloid leukemia or myelodysplastic syndrome that has spread to other     places in the body and usually cannot be cured or controlled with treatment. Giving     chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor     peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and     helps stop the patient's immune system from rejecting the donor's stem cells. Also,     radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find     cancer cells and carry cancer-killing substances to them without harming normal cells. When     the healthy stem cells from a donor are infused into the patient they may help the patient's     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving fludarabine phosphate and total-body irradiation before the transplant together with     cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.     Giving a radiolabeled monoclonal antibody together with donor stem cell transplant,     cyclosporine, and mycophenolate mofetil may be an effective treatment for advanced acute     myeloid leukemia or myelodysplastic syndromes.   "
173946|NCT00119379|"     HIV lipoatrophy is a condition marked by fat loss; it occurs in many patients taking     antiretroviral (ARV) therapy that includes nucleoside reverse transcriptase inhibitors     (NRTIs). Lipoatrophy may be related to mitochondrial toxicity, a condition that can damage     the heart, nerves, muscles, kidneys, and liver, and can affect the body's ability to produce     energy. NucleomaxX is a food supplement consisting of a sugar cane extract high in     nucleosides, which are building blocks that may counteract the negative effects of NRTIs.     Tenofovir disoproxil fumarate (TDF) is an NRTI that may cause less lipoatrophy than other     drugs in its class, such as zidovudine (ZDV) or stavudine (d4T). The purpose of this study is     to determine whether nucleoside supplementation with NucleomaxX and substitution of TDF for     ZDV or d4T in an ARV regimen can reverse fat loss caused by mitochondrial toxicity in HIV     infected adults.      Study hypotheses: 1) The substitution of TDF for d4T or ZDV in patients with HIV lipoatrophy     will result in an increase in mitochondrial DNA content in fat, skeletal muscle, and     peripheral blood mononuclear cells (PBMCs), which in turn will lead to an improvement in     mitochondrial function as assessed by electron transport chain (ETC) and oxidative     phosphorylation pathway (OXPHOS) activity. The latter should lead to a decrease in fat     apoptosis and in mitochondrial and lipid oxidative damage biomarkers. 2) Supplementation with     uridine (via NucleomaxX) will increase mtDNA content in adipose tissue and increase body fat     content.   "
173947|NCT00119392|"     Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block find cancer cells     and either kill them or carry cancer-killing substances to them without harming normal cells.     Giving monoclonal antibodies, low doses of chemotherapy, such as fludarabine phosphate, and     low dose total-body radiation therapy before a donor peripheral stem cell transplant helps     stop the growth of cancer cells and also stops the patient's immune system from rejecting the     donor's stem cells. The donated stem cells may replace the patient's immune cells and help     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     cyclosporine or mycophenolate mofetil after the transplant may stop this from happening   "
173948|NCT00119405|"     Nucleoside reverse transcriptase inhibitors (NRTIs) are a class of anti-HIV (Human     Immunodeficiency Virus) drug that can be an important part of an HIV treatment regimen.     Because anti-HIV therapy may have negative side effects, there is a great need to carefully     study HIV infected patients on such regimens. One negative side effect observed in many HIV     infected patients is lipoatrophy, a condition that results in fat loss in the body. It is     unclear if NRTIs also have a role in the development of mitochondrial toxicity, a condition     that affects the body's ability to produce energy. The purpose of this study is to observe     the effects of an NRTI-based, protease inhibitor (PI)-sparing drug regimen on fat loss in HIV     infected, treatment-naive adults.      Study hypothesis: The initiation of NRTI-containing, PI-sparing therapy will inhibit     mitochondrial DNA (mtDNA) synthesis and lead to a decrease in mtDNA content in adipose     tissue, skeletal muscle and peripheral blood mononuclear cells (PBMCs), will cause     deterioration in mitochondrial function, will increase fat apoptosis and oxidative damage     biomarkers, and will lead to progressive decrease in body fat content.   "
173949|NCT00119418|"     This study tests to see if TU 025 Keishi Bukuryo Gan reduces the frequency and severity of     hot flashes in post-menopausal American women. This study will also estimate the best dose     amount and determine the common short-term side effects and risks.   "
173973|NCT00119730|"     -  The purpose of this study is to find out whether combining a short course of          chemotherapy (Fludarabine, Mitoxantrone and Rituximab) followed by Zevalin will be          effective in treating relapsed mantle cell lymphoma.        -  The secondary purposes of the study are to determine the safety and to evaluate whether          there is additional benefit from Zevalin therapy following the chemotherapy.   "
173974|NCT00119743|"     The purpose of this study is to assess the efficacy in young children in preventing acute     otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza,     following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary     vaccination in the first year of life, with booster dose in the second year of life.     Prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo     (hepatitis A vaccine).   "
173989|NCT00119964|"     The purpose of this study is to determine if an internet-based intervention will be effective     in improving the lifestyle and weight of an obese employee population.      The intervention will last 12 months, and includes a weight tracker, a food intake tracker,     an activity tracker, a calorie balance tool, an electronic discussion board, and electronic     greeting cards.   "
173990|NCT00119977|"     The purpose of this study is to evaluate the effect of performing a periacetabular osteotomy     on patients with hip dysplasia.   "
174153|NCT00113750|"     Tree MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide     pre-seasonal specific immunotherapy for patients with hypersensitivity to tree (birch, alder,     and hazel) pollen. Different doses of Tree MATA will be administered and immunological     changes following this treatment will be assessed.   "
173950|NCT00119431|"     A multicentre study to investigate pharmacokinetics, clinical efficacy and safety of     nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the     treatment of hereditary angioedema (HAE) will be performed. This study KB2003.01 consists of     three parts, part A pharmacokinetics (phase II), part B treatment of attacks of angioedema     (phase III) and part C prophylactic use of C1 inhibitor (phase III). Part B + C will provide     data on the efficacy of C1-esteraseremmer-N.      The changes in the manufacturing process of C1-esteraseremmer-N, compared to Cetor® (the     currently marketed C1-inhibitor product), nanofiltration and omission of hepatitis B     immunoglobulin, most likely will not affect tolerability. The nanofiltration will provide     more safety regarding viruses.      In part A, the pharmacokinetics of C1-esteraseremmer-N in patients with hereditary angioedema     will be compared with the current registered product, Cetor®, in a randomised, blinded     cross-over design. This study has to provide evidence that changes in the manufacturing     process have not affected pharmacokinetics. In addition, this study provides data on safety     of C1-esteraseremmer-N.   "
173951|NCT00119444|"     The purpose of this study is to examine the blood flow in acetabulum after periacetabular     osteotomy by Positron Emission Tomography (PET).   "
173952|NCT00119457|"     The purpose of this study is to determine whether TTP889 prevents venous thromboembolism     following surgery to repair hip fracture.   "
173953|NCT00119470|"     This trial examines the role of EUS-FNA (Oesophageal Endoscopic Ultrasound with Fine Needle     Aspiration) as an endoscopic technique for the mediastinal staging of patients with lung     cancer.      Patients will be randomized to either conventional surgical technique or EUS-FNA.   "
173954|NCT00119483|"     Male hypogonadism is a clinical situation characterized by a low serum testosterone level in     combination with a diversity of symptoms and signs such as reduced libido and vitality,     decreased muscle mass, increased fat mass and depression. Similar symptoms in combination     with subnormal testosterone levels are seen in some elderly men. Low testosterone levels are     associated with known cardiovascular risk factors, and men with diabetes and stroke have     lower testosterone levels than healthy men. Even though several publications have suggested     that testosterone treatment in hypogonadal men may have beneficial effects, it is still     uncertain if testosterone substitution in the aging man is indicated. Despite this     uncertainty the sale of testosterone has increased enormously the last few years.      We hypothesize that older men with subnormal testosterone levels have a varying degree of     dysfunction/symptoms both physically and mentally, and that these dysfunction/symptoms can be     improved with testosterone treatment.   "
173955|NCT00119496|"     Asthmatic smokers display a blunted response to both inhaled and oral corticosteroid     treatments and are at increased risk for exacerbations and near fatal asthma. The prevalence     of smoking in asthmatics runs between 20-30%. Therefore, new, more efficacious treatments are     required.      Recent work has demonstrated a mechanism which may explain steroid resistance. A commonly     used drug called theophylline can reverse this steroid resistance in laboratory studies.     Another commonly used drug, rosiglitazone can reverse smoking induced lung inflammation in     laboratory studies.      The investigators aim to study the effects of these drugs on smoking asthmatics' lung     function and other parameters including quality of life and asthma control.   "
173956|NCT00119509|"     The study compares the psychosocial outcomes of different management strategies for women     with minor atypia (including ‘HPV effect’) detected on Pap smears: conventional management (a     repeat Pap smear at 6 months) versus Human papillomavirus (HPV) DNA testing, a new method     proposed for the management of minor atypia and the informed choice of either management     supported by a decision aid.      The study examines women’s informed preferences for each of these options and compares the     psychosocial outcomes in women who are or are not given the choice of management.      HPV DNA testing offers considerable changes to the management of women with minor atypia and     there is evidence from the USA which suggests that the use of HPV DNA testing as a triage     strategy is effective for women within this group (Solomon et al 2001). The introduction of     HPV DNA testing may bring both benefits and harms to women. These harms and benefits are not     well understood. Examination of the psychosocial outcomes of HPV DNA testing compared to     conventional management and women’s preferences for each is needed to guide decisions     concerning HPV DNA testing in cervical screening in Australia and also internationally.   "
173957|NCT00119522|"     Brief Summary Detailed Description Background: A multitude of risk factors for falling has     been reported for the elderly, however many of these risk factors are not applicable to     persons with a spinal cord injury, who use a wheelchair for mobility. The objectives of this     study are to: (1) describe the incidence and prevalence of tips, falls, and fall-related     injuries in SCI; (2) describe the epidemiology of the fall event (person, time, place, and     activity); (3) describe any injuries associated with a fall, including the mechanism and     nature of the injury, severity of injury, as well as treatment required; (4) determine the     risk factors related to falls and fall-related injuries in SCI, and develop a model for     predicting falls and fall-related injuries in SCI; (5) determine healthcare utilization as     well as direct and indirect costs associated with fall-related injuries in SCI; and (6)     describe patient-perceived short- and long-term consequences of falls in SCI. The data     collection for this study was completed on March 31, 2007, and data analysis is in final     phase.      Objectives: The objectives of the study are to describe: (1) the incidence and prevalence of     wheelchair tips, falls, and fall-related injuries; (2) epidemiology of event; (3) injuries     associated with event, including mechanism, nature, severity of injury and treatment     required; (4) determine risk factors and develop a model for predicting tips and falls; (5)     determine healthcare utilization and direct and indirect costs; and (6) describe perceived     short- and long-term consequences of falls in SCI.      Methods: This is a prospective cohort study. Data was collected through patient surveys,     medical records, and VA databases. Baseline information includes risk factors (e.g., user     characteristics, wheelchair features, wheelchair activities, etc.) and physical environmental     data. Monthly follow-up calls tracked tips, falls, and injuries.      Status: Recruitment ended on April 1, 2006 with a total of 702 subjects, and data collection     was completed on March 31, 2007. The Data Safety Monitoring Board for this study conducted     its final meeting on September 17, 2007. Data has been analyzed and 17 manuscripts are     currently in development.      Impact: While much is known about falls in elderly, there is a lack of understanding of the     epidemiology of wheelchair-related falls. Our project is expected to identify previously     unaccounted for factors that predispose persons with SCI to falls and fall-related injuries.     This study will result in the creation of a model for predicting falls and fall-related     injuries in SCI. The predictive model will be used to develop intervention strategies     targeting modifiable risk factors. Eventually, we will test this predictive model with other     vulnerable veteran populations. Findings from this study wil be used to develop an instrument     to identify fall risk in persons with SCI.   "
173958|NCT00119535|"     The study's primary objective is to determine whether the PRSS improves the optimal timing of     photocoagulation in diabetic patients in VA. Secondary objectives include assessing if the     program: (1) leads to improved compliance with retinopathy screening and surveillance visits;     (2) improves patient and provider satisfaction with VA diabetic eye care; (3) reduces eye     care visit rates among diabetics receiving eye care at VA; (4) decreases health care resource     utilization; and (5) improves the cost-effectiveness of eye care for patients with diabetes   "
173975|NCT00119756|"     The purpose of this study is to evaluate the safety and tolerability of intramuscular     injections (to the buttocks or to the shoulders) of paliperidone palmitate in patients with     schizophrenia.   "
173959|NCT00119548|"     Background: HIV testing is cost-effective in unselected general medical populations, yet     testing rates among those at-risk remain low, even among those with regular primary care. HIV     rapid testing is effective in many healthcare settings but scant research has been done     within primary care settings, nor within the US Department of Veteran's Affairs Healthcare     System.      Objectives: We evaluated three methods proven effective in other diseases/settings: Nurse     standing orders for testing, streamlined counseling, and HIV rapid testing.      Design: Randomized, controlled trial with three intervention models: Model A (traditional     counseling/testing); Model B (nurse-initiated screening, traditional counseling/testing);     Model C (nurse-initiated screening, streamlined counseling/rapid testing).      Participants: 251 patients with primary/urgent care appointments in two VA clinics in the     same city (one large urban hospital, one freestanding outpatient clinic in a high HIV     prevalence area)      Measurements: Rates of HIV testing and receipt of results; sexual risk reduction; HIV     knowledge improvement.      Results: Testing rates were 40.2% (Model A), 84.5% (Model B), and 89.3% (Model C) (p=<.01).     Test receipt rates were 14.6% (Model A), 31.0% (Model B), 79.8% (Model C) (all p=<.01).     Sexual risk reduction and knowledge improvement did not differ significantly between     counseling methods.      Conclusions: Streamlined counseling with rapid testing significantly increased testing and     receipt rates over current practice without changes in risk behavior or post-test knowledge.     Increased testing and receipt of results could lead to earlier disease identification,     increased treatment and reduced morbidity/mortality. Policymakers should consider streamlined     counseling/rapid testing when implementing routine HIV testing into primary/urgent care.   "
173960|NCT00119561|"     The primary goal of the study is documentation of effectiveness of telephone support groups     to reduce caregiver burden and stress. Caregivers who participate in intervention (Telephone     Support) should experience lower levels of stress, burden and health care utilization (lower     use of psychotropic drugs, fewer scheduled/unscheduled medical visits, lower rates of     institutionalization, more efficient use of time in managing care recipient problems)     compared to those caregivers in Usual Care.   "
173961|NCT00119574|"     Policy makers and consumers are increasingly concerned about the quality and efficiency of     care provided to individuals with severe, chronic illnesses such as schizophrenia. These     illnesses are expensive to treat and present significant challenges to organizations that are     responsible for providing effective care. Occurring in 1% of the United States population,     schizophrenia accounts for 10% of permanently disabled people, and 2.5% of all healthcare     expenditures. Clinical practice guidelines have been promulgated. Schizophrenia is treatable     and outcomes can be substantially improved with the appropriate use of antipsychotic     medication, caregiver education and counseling, vocational rehabilitation, and assertive     treatment. However, in the VA and other mental health systems, many patients with     schizophrenia receive substandard care. Methods are needed that improve the quality of usual     care for this disorder while being feasible to implement at typical clinics.      To date, most efforts to improve care for schizophrenia have focused on educating clinicians     or changing the financing of care, and have had limited success. We believe a more     fundamental approach should be tried. While there are many potential strategies, experience     in chronic medical illness and mental health support the efficacy of specific approaches.     Collaborative care models are one such approach. They are a blueprint for reorganizing     practice, and involve changes in division of labor and responsibility, adoption of new care     protocols, and increased attention to patients' needs. Although collaborative care models     have been successful in other chronic medical conditions, they have not yet been studied in     the treatment of schizophrenia.      We have developed a collaborative care model for schizophrenia that builds on work in other     disorders, and includes service delivery approaches that are known to be effective in     schizophrenia. The model focuses on improving treatment through assertive care management,     caregiver education and support, and standardized patient assessment with feedback of     information to psychiatrists. This project, EQUIP (Enhancing Quality Utilization In     Psychosis) is implementing collaborative care and evaluating its effectiveness in     schizophrenia.   "
173962|NCT00119587|"     The purpose of this study is to compare once a week and once every other week darbepoetin     alfa on the change in hemoglobin levels between the screening/baseline period and the     evaluation period (weeks 25-30). This study will also assess the change in mean hemoglobin     over 4 week intervals, instability of hemoglobin concentrations, darbepoetin alfa dosing     requirements and red blood cell transfusions.   "
173963|NCT00119600|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG     114 administered subcutaneously for the treatment of chemotherapy induced anemia in subjects     receiving multicycle chemotherapy.   "
173964|NCT00119613|"     The purpose of this study is to evaluate whether increasing or maintaining hemoglobin     concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy     in subjects with previously untreated extensive-stage small cell lung cancer (SCLC),     increases survival.   "
173965|NCT00119626|"     This study will determine if NXY-059 will reduce functional disability from an acute stroke.     The study is designed to look at both overall recovery and recovery of motor function, for     example muscle strength and coordination.   "
173966|NCT00119639|"     This is a 400 mg (2 x 200 mg tablets) sorafenib single dose, open-label study being conducted     to compare the pharmacokinetics of plasma and urine and safety of sorafenib in subjects with     severe, moderate, and mild renal impairment with those exhibiting normal renal function.   "
173967|NCT00119652|"     The purpose of this study is to determine whether quetiapine is effective and safe in the     acute treatment of bipolar depression and whether the effect is maintained when treatment is     continued.   "
173968|NCT00119665|"     The researchers propose a Phase II randomized, double-blind, placebo-controlled trial of 180     healthy postmenopausal women experiencing at least 5 hot flashes per day or 35 hot flashes     per week. Women will be randomized to one of three arms: 4.5 grams/day (dry weight of     extract) of MF101, 9.0 grams/day (dry weight of extract) of MF101 or placebo for 12 weeks.   "
173969|NCT00119678|"     The purpose of this clinical research study is to learn whether Abatacept can treat and     prevent lupus flares; specifically, in patients with active lupus flares in at least one of     three organ systems: skin (discoid lesions); inflammation of the lining of the heart     (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or     inflammation of more than 4 joints (arthritis). All participants will receive prednisone or     prednisone-equivalent treatment in combination with study medication. The safety of this     treatment will also be studied.   "
173970|NCT00119691|"     The researchers hypothesize that the addition of nesiritide to standard therapy will prevent     worsening of renal function in patients admitted to the hospital with decompensated heart     failure and renal dysfunction relative to standard therapy alone.   "
173971|NCT00119704|"     The purpose of this study is to determine whether Botulinum A toxin is effective in the     treatment of tennis elbow (lateral epicondylitis).   "
173976|NCT00119769|"     The purpose of this study is to investigate the effect of low-dose human growth hormone     therapy on immune status and fat morphology.   "
173977|NCT00119782|"     Reducing the prevalence of obesity in the population is one of the Healthy People 2010 goals.     Increased vigilance is required in all age groups in preventing and reversing overweight and     obesity. On an individual level, behavioral factors that influence body weight include eating     choices leading to excess calorie intake and physical activity patterns leading to diminished     calorie expenditure. An imbalance between the two over time leads to increased weight. On a     population basis, the prevalence of overweight is associated with a myriad of influences,     including social, behavioral, cultural, and environmental factors as well as genetic and     physiological factors. For a majority of overweight individuals, restoring a balance between     energy intake and expenditure is difficult, and therefore there is an increasing emphasis on     preventing obesity on a population level. The long-term goal of this research is to prevent     further increase in rates of obesity in the population. In the adult population of working     age, a majority of the day is spent in the worksite, suggesting that interventions at the     worksite level may offer the opportunity for success in this age group. It is anticipated     that this project will yield important contributions to the understanding of obesity     prevention.   "
173978|NCT00119795|"     To test the effects of exercise and weight loss on mobility disability of older     overweight/obese men and women who have evidence of cardiovascular disease or the metabolic     syndrome.   "
173979|NCT00119821|"     To evaluate the effectiveness of lifestyle modification following a smoking cessation program     in preventing weight gain among hypertensive smokers placed at medical risk by the     post-cessation weight gain.   "
173980|NCT00119834|"     The Intermacs registry is a national quality improvement system designed to advance the     understanding and application of mechanical circulatory support in order to improve the     duration and quality of life in patients with advanced heart failure.   "
173981|NCT00119847|"     The purpose of this study is to determine if opening blocked arteries with heart balloons and     stents prevents heart rhythm problems in individuals 3 to 28 days after a heart attack.   "
173982|NCT00119873|"     The purpose of this study is to determine the safety of and immune response to an     experimental HIV vaccine in HIV uninfected individuals.   "
173983|NCT00119886|"     The study seeks to evaluate the effect of botulinum toxin on vulvar vestibulitis (VVS) after     local injection with Botox, a potential treatment to relieve patients of vulvar pain,     reducing the need for painkillers, and improving the sexual quality of life of the patients.   "
173984|NCT00119899|"     Objective(s) of the proposed study:        -  The evaluation of the efficiency of 18F deoxyglucose-Positron Emission Tomography          (FDG-PET) in staging patients eligible for hepatic resection of colorectal liver          metastases in a randomized clinical multicentre setting.      Research questions of the proposed study:        -  What are the effects and costs for patients with liver metastases of colorectal cancer          indicated for potentially curative hepatic resection, using the conventional diagnostic          strategy with computed tomography (CT) scan in comparison to the experimental diagnostic          strategy incorporating FDG-PET scan (CT + FDG-PET scan), based on a health care          perspective and a time horizon of 9 months.      More specifically:        -  Does the experimental diagnostic strategy which includes FDG-PET scan in the diagnostic          work-up of patients eligible for potentially curative hepatic resection of colorectal          liver metastases lead to a better disease-free survival at 9 months after hepatic          resection in comparison to the conventional diagnostic strategy using CT scan without          FDG-PET scan.        -  What are the costs of diagnostic and therapeutic care for the two diagnostic strategies          for patients eligible for potentially curative hepatic resection of colorectal liver          metastases.        -  What is the effect of including the FDG-PET scan in the diagnostic work-up of patients          eligible for potentially curative hepatic resection of colorectal liver metastases after          hepatic resection, expressed as disease-free survival at 9 months adjusted for quality          of health (Q-TWIST), in comparison to the use of CT scan only.   "
173985|NCT00119912|"     The purpose of this study is to see if screening with flexible sigmoidoscopy (a flexible     viewing tube) may reduce large bowel cancer and cancer deaths. The researchers also want to     see if the addition of screening for occult blood in stools may contribute further to this     aim. Additionally, the researchers also want to see to which extent (and in which direction)     the study may influence overall endoscopic activity in the general population in the     screening area and in areas where controlled screening is not established.   "
173986|NCT00119925|"     The purpose of this study is to compare two different strategies to implement the existing     Guideline programme on Subfertility, as issued by the Dutch Society of Obstetrics and     Gynaecology (NVOG). Therefore, an innovative patient-directed strategy will be compared to a     control strategy and effectiveness, costs and feasibility of both strategies will be     assessed.   "
173987|NCT00119938|"     The purpose of this study is to see if an online program for patients with diabetes helps     patients improve their self-care (how they take their medications, what they eat, how much     they exercise, and whether they smoke).   "
173988|NCT00119951|"     The purpose of this study is to assess the impact of participation in the Association of     Cancer Online Resources (ACOR) mailing lists on chronic disease management for cancer     patients, we are focusing on several priority areas. These include factors that influence the     use of online interventions over time and the effects of patient-provider interactions on the     use of eHealth interventions (as well as vice versa). We also are breaking new ground in a     number of important methodological areas related to online survey research.      Our specific aims are:        1. Conduct a qualitative analysis of a 10% sample of messages (approximately 5,200)          obtained over 5 months from 9 ACOR lists to develop a comprehensive set of potential          chronic disease management outcomes and a fuller understanding of the issues and themes          that characterize list participation. The content analysis will identify important          themes and issues in the messages. These themes and issues will help in survey          refinement and ground our proposed quantitative survey questionnaire items. Survey          analyses will also be enriched by the qualitative data. Finally, the qualitative          analysis will stand as an independent body of work.        2. Conduct a web-based survey of at least 1,680 new ACOR mailing list patient members and          approximately 1,680 non-patient subscribers to assess the positive and negative effects          of participation in ACOR lists at one month and four months after joining the list and          completing a baseline survey.        3. Disseminate study findings to ACOR leadership, participants and the larger online          community.        4. Develop a plan to convert the findings into training, recommendations, tools and          policies to improve list processes. We aim to answer real world, practical questions          using methodology that is at once rigorous, practical and ethical. The components are          inter-related and complementary.   "
174001|NCT00120120|"     The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the     efficacy and safety of lenalidomide in the treatment of painful lumbar radiculopathy.   "
173992|NCT00120003|"     The purpose of this trial is to assess whether the blood pressure lowering agent candesartan     (an angiotensin receptor type 1 blocker) is effective when given to patients with acute     stroke and elevated blood pressure.      Hypothesis:      AT1 receptor blockade with candesartan in acute stroke will:        1. reduce the risk of death or major disability at 6 months by a 6% absolute risk          reduction, relative to placebo.        2. reduce the risk of the combined event of vascular death, myocardial infarction, or          stroke during the first 6 months by a 25% relative risk reduction, relative to placebo   "
173993|NCT00120016|"     Epidemiological observations indicate that a Greek-Mediterranean dietary pattern has great     potential for cancer prevention, but more definitive data on the preventive effects of this     diet are needed. Two distinct aspects of this eating pattern are the type of fat consumed and     a high fruit/vegetable intake. If the diet is feasible, it could be used in future clinical     trials of breast cancer prevention. In this study, women randomly receive either a control     diet or an intervention diet for 6 months. The intervention diet replaces half of the typical     American fat intake with foods such as olive oil and nuts. The fruit and vegetable goal is     7-9 servings/day and includes several categories of fruits, vegetables, and herbs. Blood     samples are drawn and analyzed for fatty acids derived from fats, micronutrients from fruits     and vegetables, and markers of oxidative stress. This dietary trial will provide important     data on the ability of women following typical American eating patterns to change their     dietary intakes to reflect a Greek-Mediterranean pattern.   "
173994|NCT00120029|"     The efficacy of peer counseling for weight loss maintenance is being tested in obese and     overweight African American breast cancer survivors.   "
173995|NCT00120042|"     Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead,     severely malformed or in cases of maternal illness. This process is usually conducted     medically in Australia, using the prostaglandin E1 analogue misoprostol. This prostaglandin,     although not specifically licensed for use in pregnancy termination, is now a common     abortifacient with a lot of accumulated experience both within Australia and internationally.      Since 1996, misoprostol, a synthetic prostaglandin, has been used at King Edward Memorial     Hospital as the principal agent for second trimester pregnancy termination. This agent is     administered vaginally, and in its current form and dosage regimen results in 75-80% of women     delivering within 24 hours. As experience with this agent has grown, it has been observed     that in approximately 40% of women the placenta is either completely retained or incompletely     delivered, necessitating operative removal and an increased potential for maternal blood     loss. In this study, it is planned, in a randomized controlled clinical trial, to evaluate     three regimens for the management of placental delivery in women undergoing second trimester     pregnancy interruption. The primary intention of this study is to develop a third stage     management protocol to reduce the incidence of placental retention in second trimester     medical pregnancy termination.      The secondary aim of this study is to assess the ultrasound appearance of the uterus and its     cavity within 24 hours of second trimester pregnancy termination. The ultrasound appearances     of the uterus following second trimester pregnancy loss have not been previously investigated     in detail. Previous ultrasound studies of the term postpartum uterus have demonstrated a high     incidence of echogenic material within the uterine cavity soon after an uncomplicated vaginal     delivery. These findings have been of concern as the ultrasound appearances may erroneously     imply a need for operative intervention. The investigators wish to ascertain if this high     incidence of echogenic tissue presence is also true in the second trimester. Ultrasound is     frequently used by clinicians to define placental completeness and the potential requirement     for surgical curettage. The data from this single sonographic examination of the uterus will     provide baseline data for a planned longitudinal study of uterine appearances following     second trimester pregnancy loss and their correlation with clinical symptoms.   "
173996|NCT00120055|"     The aim of this study is to investigate whether the pharmacokinetics of atorvastatin and/or     its metabolites is altered in patients with confirmed atorvastatin-induced myopathy compared     to healthy controls.   "
173997|NCT00120068|"     Nursing Home Acquired Pneumonia (NHAP) causes excessive morbidity, mortality,     hospitalization, and loss of function. At any given time, 1.1-2.5% of veterans who reside at     nursing home care units (NHCUs) and State Veterans Homes (SVHs) are ill with pneumonia.     Multi-faceted implementation of evidence-based guidelines has been shown to be feasible in     the private sector. Retrospective studies demonstrate an association between guideline     adherence and improved survival.   "
173998|NCT00120081|"     The primary objective of this clinical trial is to determine the safety and tolerability of     the Na-ASP-2 Hookworm Vaccine in healthy subjects following the administration of 3     intramuscular (IM) injections of the vaccine over 16 weeks using 3 different doses. The     secondary objective is to make a preliminary evaluation of the immunogenicity of each of the     3 doses of the vaccine in healthy volunteers.   "
173999|NCT00120094|"     This is a multi-center, prospective, observational study enrolling 400 patients with     suspected or certain neurally-mediated syncope, who undergo carotid sinus massage, tilt     testing and Implantable Loop Recorder (ILR)implantation. In its second phase, which starts     after the first ILR-documented syncope, the study will register the patient outcome after     administration of ILR-guided therapy, which is left to the discretion of the physicians. The     main objective is to verify the value of ILR in assessing the mechanism of syncope and the     efficacy of the ILR-guided therapy after syncope recurrence.   "
174000|NCT00120107|"     The researchers propose a pilot study of the effect of long-term tea intake on     atherosclerosis. Thirty patients at high risk for cardiovascular disease will be recruited     and randomized to a six-month period of consumption of 3 cups per day of either tea, supplied     as black tea solids readily dissolved in hot or cold liquid, or water.      At baseline and after 6 months, atherosclerosis in the aorta will be assessed using magnetic     resonance imaging. The primary outcomes of this pilot study will be compliance with tea     intake and 2 MRI examinations. As secondary outcomes, standard and novel cardiovascular risk     markers, including inflammatory, prothrombotic, fibrinolytic, vascular and metabolic factors     will be measured.      If successful, this pilot study will form the basis for a larger, long-term randomized trial     to determine the effect of tea consumption on progression of atherosclerosis.   "
174002|NCT00120133|"     In the proposed randomized double blind cross-over placebo controlled study, the researchers     intend to investigate if Atorvastatin (FDA approved statin for children) can be used to     alleviate the symptom of bone pain (acute phase reaction) that is commonly associated with     initial doses of pamidronate or zoledronic acid, and also the mechanism that underlies this     proposed beneficial effect of Atorvastatin. The primary outcome studied will be alleviation     of bone pain by Atorvastatin compared to placebo by visual analogue pain scale in children     treated with pamidronate or zoledronic acid. The secondary outcome investigated will be     changes in blood count and γδT cell count, C-reactive protein (CRP) and cytokine levels of     interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and gamma interferon (γ-IFN)     following treatment with Atorvastatin compared to placebo.   "
174155|NCT00113776|"     The purpose of this study is to examine the safety of ABX-EGF administered as monotherapy in     subjects with metastatic colorectal cancer who were previously randomized to best supportive     care (BSC) in protocol 20020408 and subsequently determined to have progressive disease.   "
174003|NCT00120159|"     The general objectives of this protocol are to develop a multi-center prospective data     collection process to identify risk factors for progression of Necrotizing Enterocolitis     (NEC). These data will be used as a basis for identifying management strategies appropriate     for further evaluation (randomized controlled trials), to develop evidence-based standards of     care, and as a tool to facilitate quality-assessment at individual centers through comparison     of outcomes with the entire database.   "
174004|NCT00120172|"     Currently there is no one standard of care for older patients with metastatic colorectal     cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus     bevacizumab. The study will also gather information on the usefulness and side effects of     this treatment combination.   "
174005|NCT00120185|"     Interleukin-2 (IL-2) increases the number of CD4 cells in HIV-1 infected patients under     highly active antiretroviral therapy (HAART) with a CD4 cell count over 200/mm3, but its     activity in patients without antiretroviral therapy is unknown. This study will test the     efficacy and safety of IL-2 in naïve patients with a CD4 count between 300 and 500/m3.   "
174006|NCT00120198|"     Currently there is no one standard of care for older patients with Non-Hodgkin's Lymphoma     (NHL). The study will examine the tolerability and feasibility to the combination of     Cyclophosphamide, Pegylated Liposomal Doxorubicin, Vincristine, Prednisone (CDOP) plus     Rituximab.   "
174007|NCT00120211|"     This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy     used in the treatment of head and neck cancer.   "
174008|NCT00120224|"     This study will investigate the possibility that medical abortion using mifepristone and     misoprostol - a safe, proven therapy for terminating early first trimester pregnancy - can be     administered in a manner that is simpler and less costly than that routinely employed in the     United States.      The researchers hypothesize that:        1. Practitioners themselves, based on history and examination but without sonography, are          able to dependably and correctly determine which patients are eligible for medical          abortion and which patients either are not eligible or require further evaluation to          determine eligibility.        2. Practitioners themselves, based on a symptom diary and low-sensitivity pregnancy test          but without sonography, are able to dependably and correctly determine when a successful          medical abortion has taken place and when referral for other possible outcomes should be          made.        3. A symptom diary and low-sensitivity pregnancy test are safe and effective means of          separating those women who could benefit from a follow-up visit from those who do not          need one.   "
174009|NCT00120237|"     This community-based trial will study misoprostol for the prevention of postpartum hemorrhage     in rural Pakistan. Traditional birth attendants assisting home deliveries will administer     study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women     participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables     will be evaluated.   "
174010|NCT00120250|"     The purpose of this study is to obtain data investigating the safety and efficacy of     eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep     disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine     correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more     effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in     sleep will be associated with improvement in overall PTSD symptoms, and patients with     PTSD-related sleep disturbances will have abnormal levels of stress hormones.   "
174011|NCT00120263|"     Background:Plasma exchange has been suggested to be of theoretical benefit in the treatment     of acute renal failure at the onset of multiple myeloma. Two small-randomized trials provide     conflicting evidence.      Objective: To assess the effect of 5 to 7 plasma exchanges in the treatment of acute renal     failure at the onset of multiple myeloma.      Design: Randomized controlled trial with 4 strata (chemotherapy and dialysis dependence) from     1998 to 2004.      Setting: Hospital plasma exchange units in 14 major Canadian medical centers.      Participants: 92 voluntary patients between the ages of 18 to 81 with acute renal failure at     the onset of myeloma after volume repletion and hypercalcemia.      Intervention: 5 to 7 plasma exchanges of 50 ml/Kgm of 5% Human Serum Albumin in first 10 days     plus conventional therapy versus conventional therapy alone.      Measurements: The primary outcome is a composite measure of death, dialysis dependence or     Modification of Diet in Renal Disease Study glomerular filtration rate (MDRD GFR) <     30mg/min/1.73 meter squared at 6 months.   "
174012|NCT00120276|"     The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the     safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open     surgical repair of the mitral valve using an annuloplasty ring or band in patients with     moderate to severe functional mitral regurgitation.   "
174013|NCT00120289|"     The purpose of this study is to determine whether raising good cholesterol with a drug     based on the vitamin niacin, while lowering bad cholesterol with a statin drug, can prevent     more heart disease than the statin alone.   "
174014|NCT00120302|"     This study is not being conducted in the US.      The study consists of a 4 week double blind treatment period. All patients meeting the     inclusion/exclusion criteria will enter the study at day 0 and be randomized into either     pimecrolimus cream 1% or vehicle treatment groups in a 1:1 ratio. Patients will return to     clinic on days 7,14 and 28 for assessments of disease severity. Patients who experience an     unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the     study.      Assessments of eligibility include an Investigator's Global Assessment and Pruritus score.     Treatment history will be collected at baseline and Quality of Life Questionnaires will be     carried out at every visit.   "
174073|NCT00112632|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor     so that it can be removed.      PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating     patients with locally advanced gastrointestinal stromal tumor.   "
174154|NCT00113763|"     The purpose of this study is to determine that panitumumab, using the proposed regimen, will     safely increase progression free survival in patients with metastatic colorectal cancer who     have failed available treatment options (i.e., patients who developed progressive disease or     relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).   "
174019|NCT00120367|"     Progressive multifocal leucoencephalopathy (PML) is a rare infectious disease of the brain,     provoked by the JC virus. It usually occurs in subjects with impaired immune system as during     HIV infection. To date, there is no specific antiviral treatment susceptible to cure PML. But     it was shown in the setting of HIV-related PML, that combination antiretroviral therapy     allows a restoration of the immune system and then might stop the progression of PML.      The objective of this study is to appreciate the supplementary efficiency brought by an     association of more powerful antiretroviral molecules including enfuvirtide on the evolution     of PML. This research program will involve 30 patients in several centres in France. All the     patients who will participate will receive enfuvirtide during 6 months in association with a     combination of two or more potent antiretroviral drugs. The total duration of follow-up for a     patient will be of 1 year.   "
174020|NCT00120380|"     The purpose of this study is to test whether the addition of inhaled iloprost is safe and     effective in patients with idiopathic pulmonary arterial hypertension who are already being     treated with the endothelin receptor antagonist bosentan.   "
174021|NCT00120393|"     Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination     highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol     are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in     combination with current nucleoside reverse transcriptase inhibitors (NRTIs).   "
174022|NCT00120406|"     The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic     vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in     reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by     lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with     lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm     long) and will be initiated upon approval by the Food and Drug Administration (FDA).   "
174023|NCT00120419|"     The purpose of the study is to evaluate whether mycophenolate mofetil (MMF) can treat the     chronic hyperactivation of the immune system and (partly) prevent the decrease of the CD4+     T-cell count in chronically HIV-1 infected patients who are not treated with antiretroviral     therapy (ART). The researchers also want to know what the effect is of treatment with MMF on     plasma HIV-1 RNA; progression of disease (occurrence of AIDS defining events or reaching the     indication to start ART); and the safety of treatment with MMF in this patient group.   "
174024|NCT00120432|"     The purpose of this study is to compare the efficacy on pupillary dilation between the single     dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular     examination.   "
174025|NCT00120445|"     The objective of the study is to evaluate the results of using air versus expansile gas     (perfluoropropane) in the treatment of rhegmatogenous retinal detachment by pneumatic     retinopexy, comparing the retinal reattachment rate and post-operative visual recovery.   "
174026|NCT00120458|"     This study will determine the effectiveness of the herb black cohosh for treating     menopause-related anxiety symptoms in women.      Study hypotheses: 1) Black cohosh will have a superior anti-anxiety effect compared to     placebo. 2) Black cohosh will have a comparable safety profile to that of placebo.   "
174027|NCT00120471|"     To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple     yet effective treatment plan is needed. Tenofovir disoproxil fumarate (TDF) is an anti-HIV     drug approved for use in the United States for the treatment of HIV infected adults. The     purpose of this study is to determine the safety, tolerability, and blood levels of TDF in     HIV infected pregnant women and their babies. The study will be conducted at sites in Malawi     and Brazil.   "
174028|NCT00120484|"     Circadian rhythms are 24-hour cycles that influence natural functions in the body such as     heart rate, blood pressure, and body temperature. Circadian rhythms provide the body with an     internal clock and affect sleep patterns. The purpose of this study is to determine the     effects of vitamin B12 supplements on circadian rhythms and sleep-wake regulation.   "
174029|NCT00120497|"     Insulin resistance is common among children with low birthweight. Moreover, growth hormone     treatment for ensuing short stature also causes insulin resistance. Our objective is to     examine these processes. Insulin resistance has recently been linked to the accumulation of     stores of fat in muscle cells which can be measured by MRI. We hypothesize that children who     are short due to low birthweight have increased muscle fat stores, but that growth hormone     treatment will paradoxically reverse this association. To test this hypothesis, muscle fat     stores will be measured in children who are short due to low birthweight before and after     receiving growth hormone therapy. Other parameters linked to insulin resistance (glucose     tolerance, blood markers, and body composition) will also be assessed. This study may lead to     ways to increase growth hormone safety and dose limitations.   "
174030|NCT00120510|"     Anti-HIV treatment consisting of lamivudine/zidovudine (3TC/ZDV) and efavirenz (EFV) is the     current standard of care for initial treatment of HIV in most areas of the world. The purpose     of this study is to determine the best time to start this anti-HIV treatment in     treatment-naive adults in Haiti.   "
174031|NCT00120523|"     The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in     the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than     12 months of age compared to topical corticosteroids (TCS).   "
174032|NCT00120536|"     The purpose of this study is to assess the long term safety and effectiveness of three doses     of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose     levels in people with type 2 diabetes who have not previously been treated with drug therapy     to lower their blood sugar.   "
174033|NCT00120549|"     The purpose of this study was to determine if assisted embryo hatching can improve pregnancy     rates for good prognosis patients undergoing in vitro fertilization (IVF) with day 3 embryo     transfer.   "
174034|NCT00120562|"     Weight loss achieved by dieting induces multiple changes. These changes include a decrease in     metabolic rate (the rate in which the body burns its calories), an increase in appetite and     other physiological and hormonal changes that may be the cause of failure in dieting. Many of     these parameters that have never been evaluated when weight is lost after gastric bypass     surgery will be tested in this study.   "
180870|NCT00212966|"     The purpose of this study is to assess how a multidisciplinary team of mental health     professionals provides services to patients from two family medicine practices.   "
174035|NCT00120575|"     For children undergoing bone marrow transplantation, respiratory failure is a devastating     complication, with mortality expectations well above 60%. The researchers have devised a     novel strategy that may greatly improve survival. Hemofiltration, a continuous form of     dialysis, was designed as a therapy for critically ill patients with kidney failure. A     semi-permeable membrane removes plasma water and solutes (up to about 35,000 Daltons     molecular weight). The researchers have treated immuno-compromised children with respiratory     failure with hemofiltration. Many inflammatory molecules are of a size well below the limit     of the filter. Hemofiltration might remove a critical amount of this inflammatory material,     attenuating the unregulated inflammatory response that is central to the development of     respiratory failure and progression to multiple organ failure and death. The researchers are     conducting a multi-center trial of early continuous hemofiltration for respiratory failure in     children following bone marrow transplantation. The researchers will analyze blood and     ultrafiltrate using sensitive proteomic methods to detect several inflammatory biochemicals     known to be active in this disease, looking for evidence that early active hemofiltration     alters the inflammatory response. The researchers will test whether `early` hemofiltration     produces greater survival from respiratory failure in this vulnerable population.   "
174036|NCT00120588|"     Magnesium is neuroprotective in neonatal animal models of acquired hypoxic-ischemic and/or     inflammatory cerebral lesions. It is associated with a significant reduction of perinatal     death and cerebral palsy in some observational studies.      The objective of the study is to assess if prenatal magnesium sulfate given to women at risk     of preterm birth before 33 week's gestation is neuroprotective.   "
174037|NCT00120601|"     The purpose of this study is to compare the effectiveness of two anti-craving medications,     naltrexone versus acamprosate, in the treatment of alcohol dependence.   "
174038|NCT00120614|"     The purpose of this study is to determine whether beginning an enriched     educational/behavioral program for parents of premature infants, very early in the Neonatal     Intensive Care Unit (NICU) stay, and lasting until the child is 3 years old, has beneficial     results for both the parents and their infants.      The hospital phase of the program gives parents an understanding of what to expect in the     NICU environment; physical characteristics and needs of their premature baby; and how and     when to best support their infant's development during this time. The information given     during the home phase of the program continues with information specific to the growth and     development and the effective parenting of an infant/toddler who has been born prematurely.      It is believed that this information will help decrease parents' stress, anxiety and     depression levels that can be related to giving birth to a premature infant. It is also     expected that it will strengthen the mother's and father's ability to parent their premature     child in a way that will help support their child's brain development and learning ability     and to also decrease negative behaviors as the child grows.   "
174039|NCT00120627|"     With ongoing war in Iraq, the incidence of posttraumatic stress disorder (PTSD) in combat     veterans is increasing. Creation, implementation, and testing of new and innovative     interventions are needed to provide additional options for enhancing the mental health of     those with PTSD. Surveys indicate that veterans are interested in complementary approaches to     health care. The purpose of this study is to determine the efficacy of the Mantram Repetition     Program (MRP) delivered as a brief, 6-week, complementary and portable intervention. It     includes frequent, silent repetitions of a mantram (mantra), a word or phrase with spiritual     associations, to manage PTSD symptoms and improve quality of life military veterans with     trauma.   "
174040|NCT00120640|"     The goal of our research will be to determine the effectiveness of 17     alpha-hydroxyprogesterone caproate (17P) in the treatment of preterm delivery. Treatment with     progesterone is emerging as the standard of care for prevention of preterm delivery in     asymptomatic patients at high risk for preterm birth due to a prior preterm delivery. Our     goal is to evaluate whether or not progesterone is also effective in reducing preterm birth     in symptomatic patients.   "
174041|NCT00120653|"     This study will determine whether the medication metoclopramide can improve red blood counts     in people who have myelodysplastic syndrome (MDS). MDS is thought to affect blood stem cells,     which can result in low levels of red blood cells-that is, anemia-as well as low white blood     cell and platelet counts. Patients with MDS are at risk for infection, spontaneous bleeding,     and possible progression to leukemia, a cancer of bone marrow. Although bone marrow can     produce some blood cells, this production can be decreased in patients with MDS. The     definitive way to treat MDS is stem cell transplantation, but serious complications and a     high risk of death make it unsuitable for patients older than age 60 or those who do not have     a matched sibling donor. However, scientists have noted improvement in anemia by using     metoclopramide, an inexpensive, commonly used medication that does not have many negative     side effects. This study will evaluate the safety and effectiveness of that medicine for     patients with MDS.      Patients ages 18 to 72 whose MDS would require low-intensity treatment-for example, with     growth factor and transfusions-and who are not pregnant or breastfeeding may be eligible for     this study. There will be about 60 participants.      Screening tests include a complete physical examination and medical history, during which     patients will provide a list of current medications or supplements they are taking. There     will be a collection of about 4 tablespoons of blood for analysis of blood counts as well as     liver and kidney function. Patients may also undergo a magnetic resonance imaging (MRI) scan     of their brain, but the procedure is optional. During the MRI, they will lie on a table that     will slide into the enclosed tunnel of the scanner. The MRI takes about 20 to 30 minutes, and     patients will be asked to lie as still as possible. There will also be a bone marrow biopsy,     if patients have not had one done within 4 weeks of the start of this study. Eligible     patients will take a 10 mg dose of metoclopramide by mouth, three times a day, for 20 weeks.     They will be given a 4-week supply, which will be renewed monthly at each treatment visit. It     is essential that patients be seen at NIH during the first, third, and fifth months of the     study. Visits made in the meantime, at the second and fourth months, may be done at the     office of their doctors who have referred them for the study, or at NIH. During the treatment     visits, patients will be asked to update their medical history, health conditions, and use of     medications or herbal supplements. There will also be a collection of about 1 tablespoon of     blood for laboratory tests. Patients will be asked to make a similar follow-up visit 1 month     after they stop taking metoclopramide, so that the response to treatment can be evaluated.      The use of metoclopramide may cause some people to feel dizzy, lightheaded, tired, or less     alert than they are normally. For the first 24 to 48 hours, patients should be cautious when     driving, using machinery, or performing hazardous activities. This medicine will add to the     effects of alcohol and other central nervous system depressants-such as medicines for     allergies and colds, tranquilizers, and prescription pain relievers. Patients need to check     with the research team before taking any of those types of medicines, as well as herbal     supplements, while using metoclopramide.      This study may or may not have a direct benefit for participants. For some, the drug may     improve red blood cell counts and decrease the need for red cell transfusions. Knowledge     gained in the study may help people in the future.   "
174042|NCT00120666|"     This study will determine how the brain controls movements by sending messages to the spinal     cord and muscles. Researchers want to know if strengthening a hand muscle will increase the     strength of the same muscle in the other hand, and if these changes happen in the brain or     spine, or both. Plasticity in this study refers to the capacity for continuous changes of the     neural pathways in the brain and nervous system. Researchers have seen cases in which using a     muscle extensively (force production) in one muscle group has increased the strength of the     same muscle group on the opposite side of the body (force transfer). This situation happens     without the unused muscle becoming larger-suggesting that the practice causes changes in some     parts of the brain or spine. It is vital for scientists to know how this effect works, so     that they can create new rehabilitation methods for people who cannot move or who have     difficulty moving one side of their body.      Patients ages 18 to 60 who are in good health and who do not have a history of major     conditions affecting the bones, joints or nervous system may be eligible for this study.     Patients will undergo a medical examination. There will be 1 or 2 testing sessions, 20     training sessions, and 1 or 2 final testing sessions, with patients being asked to come to     the laboratory for as few as 4 times (about 10 hours total) or for up to 25 visits (about 20     hours total). The investigator will indicate which of six different groups that a patient is     selected for.      During testing sessions, the strength of the pointer and little fingers in each hand will be     determined through the use of very brief electrical pulses. There also will be transcranial     magnetic stimulation (TMS) and 1 Hz TMS. The researchers will place one or two wire coils on     the patient's scalp and make marks on the scalp which will be removed at the end of the     session. During the TMS, a brief electrical current is passed through the coil, creating a     magnetic pulse that stimulates the brain. Patients will hear a click sound and feel a     snapping sensation on the skin. They may also feel and see small twitches in the hand     muscles, and the fingers or wrist may move. There will be a total of about 300 magnetic     stimuli, at a rate of 10 pulses per minute. Patients will also have an electromyogram (EMG),     a procedure recording electrical activity in the muscles that are activated by electrical or     magnetic stimulation. Metal electrodes will be attached to the skin over the muscle. During     the EMG, patients will be asked to tense certain muscles slightly. Depending on the group a     patient is assigned to, he or she may be asked to use the right index finger by using     voluntary muscle movement, electrical stimulation, his or her imagination, electrical     stimulation of a different hand muscle, or voluntary movements immediately followed by     repetitive TMS.      Regardless of group assignment, there will be five blocks of 10 repetitions of finger     exercise per session, 200 per week, and 1,000 throughout the whole study. During the study     sessions, patients will be able to talk and move around. They can take a break and leave the     room if needed. In most cases, the session will take less than 2 hours. There also will be a     control group whose members will not be training their fingers but who will participate only     in the testing sessions. TMS is a safe procedure; however, strong contractions of scalp     muscles have been known to cause headaches. Also, because of the distracting noise of the     TMS, patients will be fitted with earplugs to wear during the procedure.      Compensation for research-related discomfort and inconvenience will be made to participants,     with a maximum of $500 to $600, depending on assignment to groups. This study will not have a     direct benefit for participants. However, researchers hope to gain information that will help     them better understand how the two sides of the brain control movement and how they affect     each other regarding movement control.   "
174043|NCT00120679|"     The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia     Treatment (PSQ-AT) in non small cell lung cancer patients treated with darbepoetin alfa or     recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.   "
174044|NCT00112216|"     The purpose of this study is to test whether vaccination with antigenic peptides induces an     immune response in the vaccine site sentinel lymph node of patients with microscopically     detectable lymph node melanoma metastases.   "
174045|NCT00112229|"     The purpose of this study is to determine whether vaccination with tumor antigenic peptides     and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and     to assess the safety of this vaccination.   "
174046|NCT00112242|"     The purpose of this study is to determine whether vaccination with melanoma antigen peptides     [Melan-A/Mart-1 (both EAA and ELA), NY-ESO-1b analog, Long NY-ESO-1 LP and MAGE-A10] and     Montanide, CpG adjuvants and low dose rIL-2 can induce an immune response in melanoma     patients and to assess the safety of this vaccination.   "
174047|NCT00112255|"     The purpose of this study was to compare the effectiveness of partner notification by general     practice nurses with referral to a specialist clinic for people with genital chlamydia     diagnosed in a community setting. We hypothesised that referral to a specialist would be more     effective in ensuring treatment of the sexual partners of infected people than the simpler     nurse-led strategy.   "
174071|NCT00112593|"     This clinical trial studies the side effects and best dose of giving fludarabine and     total-body irradiation (TBI) together followed by a donor stem cell transplant and     cyclosporine and mycophenolate mofetil in treating human immunodeficiency virus     (HIV)-positive patients with or without cancer. Giving low doses of chemotherapy, such as     fludarabine, and TBI before a donor bone marrow or peripheral blood stem cell transplant     helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system     from rejecting the donor's stem cells. The donated stem cells may replace the patient's     immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).     Sometimes the transplanted cells from a donor can also make an immune response against the     body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after the     transplant may stop this from happening.   "
174048|NCT00112268|"     Primary: To test whether the delivery of A3-5 smoking cessation counseling (Assess, Assist,     Arrange) in primary care offices is enhanced by a system that couples (1) an expanded vital     sign intervention with (2) fax referral of preparation-stage patients for telephone     counseling and (3) feedback to the provider. The question will be examined in a randomized     trial, with practices as the unit of analysis and with a control intervention consisting of a     conventional vital sign intervention. The experiment will therefore compare what intervention     and control practices accomplish beyond simply identifying patients who use tobacco.      Secondary: To assess contextual factors that might affect implementation of the intervention     and account for its ultimate success or failure. In particular, to assess: (1) environmental     and practice-level factors that affect practices’ ability to successfully implement and use     the intervention and; (2) patient characteristics beyond readiness to change (i.e., age,     gender, race/ethnicity) that affect willingness to use the quit line and complete counseling.   "
174049|NCT00112281|"     Tilarginine Acetate Injection is a new type of drug that temporarily stops the body from     making a bodily substance called nitric oxide. The body may produce excess nitric oxide     following severe heart damage leading to shock. During a heart attack, and especially after a     blocked artery causing the heart attack is reopened, a large amount of nitric oxide is     released into the heart muscle and into the blood. Normally small amounts of nitric oxide are     good for the heart and blood vessels. However, when released in large amounts, such as during     a heart attack, it may be harmful, by adding to the damage of the heart attack and lowering     the heart’s ability to pump blood to the body. It may cause blood pressure to be lowered and     reduce the amount of blood flow to the body’s vital organs. This may interfere with the     body’s organs being able to do their work. If Tilarginine Acetate Injection can stop extra     nitric oxide from being made, the performance of the heart and blood flow to the organs may     get better, which may result in the improvement of symptoms. The purpose of this study     (TRIUMPH) is to investigate the safety and effectiveness of Tilarginine Acetate Injection     compared to placebo (an inactive fluid that has no effect on the body but looks exactly like     the medication being studied). The study will help determine whether Tilarginine Acetate     Injection, by temporarily lowering the amount of nitric oxide released into the vital organs     can improve blood pressure and the blood flow to the body’s organs.   "
174050|NCT00112294|"     The primary purpose of this clinical research study is to learn if patients treated with the     combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free     survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this     treatment will also be studied.   "
174051|NCT00112307|"     The primary goal of this pilot study is to assess the feasibility of using magnetic resonance     (MR) imaging guidance in the Magnetic Resonance Therapy (MRT) unit at the Brigham and Women's     Hospital during the implantation of brachytherapy applicators in patients with gynecologic     malignancies. Patients with gynecologic malignancies requiring brachytherapy are currently     treated under either fluoroscopic or CT visualization of the brachytherapy applicator.     Magnetic resonance imaging has been shown in many studies to provide superior visualization     of the cervix, vagina and uterus compared to CT. However no prior study has examined the     feasibility of using real-time magnetic resonance imaging to assist in the guidance of     gynecologic brachytherapy applicators   "
174052|NCT00112320|"     Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart     disease, usually involves surgery on the outflow of the right ventricle (RV) and the     pulmonary valve in order to relieve obstruction to blood flow from the RV to the lungs. This     procedure often leads to regurgitation (leakage) of the pulmonary valve, which puts the     burden of handling a larger than normal amount of blood flow on the RV. Over the years, that     extra burden leads to enlargement of the RV and to a decrease in its function. Treatment     often includes surgical insertion or replacement of a new pulmonary valve. Replacement of the     damaged pulmonary valve aims to minimize the leakage and help the RV function better. This     study is designed to compare two methods of how the operation (called pulmonary valve     replacement [PVR]) is performed. In the first method, a new valve is inserted and only the     area of the old valve is operated on; this is the standard PVR. The second method involves     inserting the new valve in the same way as the standard method but, in addition, areas of the     right ventricular wall that are scarred and not functioning well are removed (PVR plus right     ventricular remodeling). This study will evaluate which method is more effective based on the     size and function of the RV measured by cardiac magnetic resonance imaging (CMR) six months     following surgery, as compared to its size and function before the operation.   "
174053|NCT00112333|"     The purpose of the study is to use functional Magnetic Resonance Imaging (MRI) to help us     understand what parts of the subject's brain are involved when he experiences visceral pain,     or pain in the gut. To stimulate the brain, he will be infused with a liquid meal (Ensure)     into his stomach until he is maximally full. Magnetic resonance imaging (MRI) is a technique     for making images (pictures) of the brain; it uses magnetic fields and radio waves and is not     harmful. This study uses a new investigational technique called functional MRI (fMRI), which     is a very fast MRI technique that will allow the investigators to evaluate changes in how     blood flows to parts of his brain.   "
174054|NCT00112346|"     The primary purpose of this study is to estimate the number of patients with non-small cell     lung cancer whose tumor responds to the treatments given in this study.   "
174055|NCT00112359|"     The purpose of this study was to evaluate the safety and efficacy of a 28-day course of     aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung     infection due to Pseudomonas aeruginosa (PA).   "
174056|NCT00112372|"     The primary objective of this current phase I trial is to study the safety and tolerability     of an orally administered dosage form of ridaforolimus. This will be accomplished by an     ascending dose study of several dosage regimens in patients with advanced malignancies.   "
174072|NCT00112619|"     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of     topotecan when given by intraventricular infusion in treating young patients with neoplastic     meningitis due to leukemia, lymphoma, or solid tumors.   "
174057|NCT00112385|"     The purpose of the study is to obtain preliminary data regarding the safety and tolerability     of etanercept in DM. In addition, we will use the study to assess the variability,     reliability, and responsiveness of the core set of outcome measures recommended by IMACS. The     study will be performed under the aegis of the Muscle Study Group (MSG), consisting of     experienced investigators with an avid interest in myopathies. The ultimate goal of this     pilot study will be to obtain necessary, prerequisite information important in designing     future therapeutic trials of etanercept and other agents in patients with DM. The specific     aims of the study are:      Aim 1: To preliminarily assess the safety and tolerability of etanercept in patients with DM.      Aim 2: To assess the safety and tolerability of prednisone in the dosing schedule we propose     to use.      Aim 3: To evaluate outcome measures recommended by IMACS and assess their variability,     reliability, and responsiveness in order to facilitate the design of future therapeutic     trials in the inflammatory myopathies.   "
174058|NCT00112398|"     The study hypothesis is that advanced interventions as provided by a physician at an accident     scene will decrease the death rate and the rate of severe disability in survivors of severe     head injury. Extended interventions by advanced level prehospital providers may include rapid     sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.   "
174059|NCT00112411|"     This study is designed to evaluate the single-dose effectiveness of two bronchodilator     inhalers given at two dose levels in pediatric asthma patients.   "
174060|NCT00112424|"     This study is a prospective, randomized study of patients with single ventricle heart disease     who are to undergo superior cavo-pulmonary anastomosis, or Glenn operation. Such patients     have historically undergone cardiac catheterization to ensure suitability for the procedure.     Cardiac magnetic resonance imaging (cardiac MRI) is a newer technology that provides     excellent anatomic and functional imaging of the heart. This study is designed to demonstrate     our hypothesis that cardiac magnetic resonance imaging will provide comparable information to     catheterization, with less side effects.   "
174061|NCT00112437|"     This is a 2-year study to examine the effects of a new experimental medication (MK0822) on     postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women,     and randomly assign them to 4 different doses of MK0822or to placebo. Measurements performed     during the study include: bone mineral density scans, spine x-rays, laboratory blood and     urine tests, height measurements and optional bone biopsies (at the end of 2 years).   "
174062|NCT00112463|"     This phase II trial studies how well depsipeptide (romidepsin) works in treating patients     with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as     depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.   "
174063|NCT00112476|"     This phase I trial is studying the side effects and best dose of temsirolimus when given     together with bryostatin 1 in treating patients with unresectable or metastatic solid tumors.     Drugs used in chemotherapy, such as temsirolimus and bryostatin 1, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.   "
174064|NCT00112489|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin     works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.   "
174065|NCT00112502|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Thalidomide may stop the growth of glioblastoma multiforme by blocking blood flow to the     tumor. Isotretinoin may help cells that are involved in the body's immune response to work     better. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. It is not yet known which temozolomide-containing regimen is more effective     in treating glioblastoma multiforme.      PURPOSE: This randomized phase II trial is studying eight different temozolomide-containing     regimens to compare how well they work in treating patients who have undergone radiation     therapy for glioblastoma multiforme.   "
174066|NCT00112515|"     RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with     cancer.      PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in     patients with cancer.   "
174067|NCT00112528|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab     together with gemcitabine and oxaliplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with     gemcitabine and oxaliplatin works in treating patients with metastatic pancreatic cancer.   "
174068|NCT00112554|"     RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well     they work compared to cytarabine alone in treating patients with relapsed acute myeloid     leukemia.   "
174069|NCT00112567|"     RATIONALE: Chemotherapy, such as fludarabine and thiotepa, and radiation therapy may destroy     cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving healthy stem     cells from a donor whose blood closely resembles the patient's blood will help the patient's     bone marrow make new stem cells that become red blood cells, white blood cells, and     platelets.      PURPOSE: This phase I/II trial is studying the side effects of total-body irradiation,     fludarabine, and thiotepa and to see how well they work in treating young patients who are     undergoing a donor stem cell transplant for hematologic cancer.   "
174074|NCT00112645|"     RATIONALE: A peripheral stem cell, bone marrow, or umbilical cord blood transplant may be     able to replace blood-forming cells that were destroyed by chemotherapy and radiation     therapy. Sometimes the transplanted cells from a donor can make an immune response against     the body's normal cells. Giving busulfan and melphalan with or without antithymocyte globulin     before transplant and cyclosporine with methylprednisolone or methotrexate after transplant     may stop this from happening.      PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in     treating young patients with relapsed or refractory solid tumors.   "
174075|NCT00112658|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. It is not yet known which     chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.      PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy     works as first-line therapy in treating patients with metastatic pancreatic cancer.   "
174076|NCT00112671|"     This phase II trial is studying how well sorafenib works in treating patients with advanced     or metastatic cancer of the urinary tract. Sorafenib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
174077|NCT00112684|"     This phase I trial is studying the side effects and best dose of alvocidib in treating     patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such     as alvocidib, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Alvocidib may also stimulate the immune system in     different ways and stop tumor cells from growing. It may also stop the growth of solid tumors     by blocking blood flow to the tumor.   "
174078|NCT00112697|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet     known whether radiation therapy, docetaxel, and fluorouracil are more effective than     radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic     cancer.      PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and     fluorouracil to see how well they work as first-line therapy compared to radiation therapy,     docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot     be removed by surgery.   "
174079|NCT00112710|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is     more effective than giving gemcitabine together with carboplatin in treating non-small cell     lung cancer.      PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how     well they work compared to gemcitabine and carboplatin in treating patients with stage III or     stage IV non-small cell lung cancer.   "
174080|NCT00112723|"     This phase I/II trial is studying the side effects and best dose of flavopiridol and to see     how well it works in treating patients with lymphoma or multiple myeloma. Drugs used in     chemotherapy, such as flavopiridol, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing.   "
174081|NCT00112736|"     Erlotinib and temsirolimus and may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. This phase I/II trial is studying the side effects and best     dose of temsirolimus when given together with erlotinib and to see how well they work in     treating patients with recurrent malignant glioma.   "
174082|NCT00112749|"     RATIONALE: Infliximab may help improve energy levels in patients who have undergone treatment     for breast cancer.      PURPOSE: This phase II trial is studying how well infliximab works in treating cancer-related     fatigue in postmenopausal women who have undergone treatment for stage 0, stage I, or stage     II breast cancer.   "
174083|NCT00112775|"     RATIONALE: BMS-354825 and imatinib mesylate may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth.      PURPOSE: This randomized phase II trial is studying BMS-354825 to see how well it works     compared to imatinib mesylate in treating patients with chronic phase chronic myelogenous     leukemia that did not respond to previous imatinib mesylate.   "
174084|NCT00112827|"     RATIONALE: Melphalan, a chemotherapeutic agent, has been found to be an effective treatment     choice for destroying myeloma cells, especially when given at high (bone marrow ablative)     doses. Total marrow irradiation (TMI)/ablative dose radiation therapy is another modality     capable of destroying myeloma cells. Autologous peripheral blood/stem cell transplant (ASCT)     given after either melphalan or following TMI (aimed at the bone marrow containing areas of     the skeleton, the site of origin of myeloma cells) will shorten the duration/alleviate the     severity of both melphalan and marrow irradiation-associated side effects. Lenalidomide, an     effective agent on its own right for the treatment of myeloma, has been shown to further     enhance the beneficial effects of autologous stem cell transplants when given as maintenance     therapy.      PURPOSE: This previously phase I trial established the maximum tolerated dose of TMI at 1600     cGy. The phase II part of this study is ongoing and is studying the effects of high-dose     melphalan and ASCT, followed by TMI and a second ASCT, with subsequent maintenance     lenalidomide. The study is conducted in patients with stages I-III myeloma, with specific     emphasis on assessing complete and very good partial response rate conversions,     progression-free and overall survival, and safety/feasibility of delivering the planned     treatment regimen.   "
174119|NCT00113308|"     This study is being conducted to find out if an investigational drug called GW406381 can help     people with rheumatoid arthritis.   "
174151|NCT00113724|"     Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is     synthetically manufactured from naturally occurring taxanes extracted from yew starting     material. The synthesis involves modification to the taxane side chain to overcome multidrug     resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose     escalation, sequential group, phase I study evaluating the intravenous administration of TPI     287, a novel third generation taxane.   "
174085|NCT00112840|"     This phase I/II trial is studying the side effects and best dose of CCI-779 and bevacizumab     and to see how well they work in treating patients with metastatic or unresectable kidney     cancer. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     find tumor cells and kill them or carry tumor-killing substances to them. Others interfere     with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of     kidney cancer by blocking blood flow to the tumor. Giving CCI-779 together with bevacizumab     may kill more tumor cells.   "
174086|NCT00112853|"     This phase I trial is studying the side effects and best dose of tipifarnib and etoposide in     treating older patients with newly diagnosed acute myeloid leukemia. Tipifarnib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as etoposide, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Giving tipifarnib together     with etoposide may kill more cancer cells   "
174087|NCT00112866|"     Cilengitide may stop the growth of glioblastoma multiforme by blocking blood flow to the     tumor. Giving cilengitide before and after surgery may be an effective treatment for     glioblastoma multiforme. This phase II trial is studying how well cilengitide works in     treating patients who are undergoing surgery for recurrent or progressive glioblastoma     multiforme.   "
174088|NCT00112879|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood     flow to the cancer. Giving arsenic trioxide together with ascorbic acid, dexamethasone, and     thalidomide may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with     ascorbic acid, dexamethasone, and thalidomide work in treating patients with multiple     myeloma.   "
174089|NCT00112892|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Selenium may allow higher doses of irinotecan to be given. Giving irinotecan together with     selenium may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of selenium when given     together with irinotecan in treating patients with advanced solid tumors.   "
174090|NCT00112905|"     This phase II trial is studying how well sorafenib works in treating patients with     progressive regional or metastatic cancer of the urothelium. Sorafenib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow     to the tumor.   "
174091|NCT00112918|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as bevacizumab, can block tumor growth in different ways. Some block the ability of     tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Bevacizumab (Bv) may also stop the growth of tumor cells by     blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab     after surgery may kill any tumor cells that remain after surgery. It is not yet known whether     giving combination chemotherapy together with bevacizumab is more effective than combination     chemotherapy alone in treating colon cancer in adjuvant setting.      PURPOSE: This randomized phase III trial is studying two different combination chemotherapy     regimens with or without bevacizumab to compare how well they work in treating patients who     have undergone surgery for high risk stage II or stage III colon cancer.   "
174092|NCT00112931|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. It is not yet known whether     rituximab is more effective than observation in treating non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying rituximab to see how well it works     compared to observation in treating patients with newly diagnosed stage II, stage III, or     stage IV follicular non-Hodgkin's lymphoma with no symptoms.   "
174093|NCT00112957|"     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective     immune response to kill tumor cells.      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients     with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal     cancer.   "
174094|NCT00112983|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of eculizumab may prevent leukemia and stop the destruction of red     blood cells in patients with paroxysmal nocturnal hemoglobinuria.      PURPOSE: This randomized phase III trial is studying how well eculizumab works in treating     patients with paroxysmal nocturnal hemoglobinuria.   "
174095|NCT00112996|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs,     such as alpha-lipoic acid, may protect normal cells from the side effects of chemotherapy.     Alpha-lipoic acid may also prevent damage to nerves that carry information to and from the     brain and spinal cord to the rest of the body. It is not known whether alpha-lipoic acid is     more effective than placebo in preventing peripheral neuropathy.      PURPOSE: This randomized phase III trial is studying alpha-lipoic acid to see how well it     works compared to placebo in preventing peripheral neuropathy in patients receiving     chemotherapy for cancer.   "
174096|NCT00113009|"     This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which     subjects with intermittent claudication (IC) will be randomized to receive a single treatment     of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline)     administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower     extremities during one procedure to evaluate the safety, tolerability, and potential activity     of VLTS-934 as compared with a saline placebo.   "
174120|NCT00113321|"     To study if decitabine can help to control Myelodysplastic Syndrome (MDS) in patients who     have failed on therapy with azacytidine, the current standard of therapy.   "
174097|NCT00113022|"     This study will evaluate the effectiveness of the experimental drug, Org 24448, for     short-term treatment of depression. It will examine the effects of the drug on symptoms, such     as low mood and persistent sadness, poor sleep and appetite, poor motivation and lack of     enjoyment of things people normally enjoy, negative thinking, and feeling slowed down or     having trouble concentrating. It will also assess whether the drug improves cognitive     function, especially memory.      Patient with major depression who do not have a serious, unstable medical illness and who are     21 to 55 years of age may be eligible for this study. Candidates are screened with a     psychiatric and medical history, diagnostic interview, physical examination,     electrocardiogram, blood tests and, for women, a pregnancy test.      Participants are tapered off anti-depression drugs (and any other medications not allowed on     the study) over a 3-week period and then begin a 2-week drug-free period. During these 2     weeks they have an electroencephalogram (EEG) with light stimulation, and those whose EEG     indicates a seizure disorder are excluded from the study. Also at the beginning of the     drug-free period they begin taking a placebo (sugar pill) twice a day. After 2 weeks on     placebo, some patients begin treatment with Org 24448, while others remain on placebo. They     continue the medication for 8 weeks, during which time they have a weekly check of vital     signs, blood and urine tests, and rating scales for depression and anxiety. Level of     functioning is evaluated twice during the study. After 8 weeks of treatment, patients have a     physical exam, electrocardiogram (ECG), EEG, blood tests, and begin to come off the study     drug, tapering the medication over a week.      In addition to the above procedures, some patients undergo the following tests during the     2-week drug-free period and again toward the end of the 8-week medication phase:        -  Neuropsychological testing, including measurements of cognitive abilities such as          memory, attention, problem-solving, and language skills.        -  Positron emission tomography (PET): This nuclear medicine test provides information          about different brain regions. The patient lies on a table in the PET scanner (similar          to a computed tomography (CT) scanner), with a mask placed over his or her face that          helps keep the head still. A sugar fluid with a radioactive material attached to it is          injected into a catheter (plastic tube) that has been inserted into a vein in the          patient's arm. The scanner detects ...   "
174098|NCT00113035|"     Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the     body's cells to break down glycogen (a stored form of sugar) within specialized structures     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates     and is stored in various tissues, especially heart and skeletal muscle, which prevents their     normal function. The primary objective of this study is to identify potential candidates for     future clinical studies in Pompe disease.   "
174099|NCT00113048|"     This phase I study will involve escalating doses of CAMPATH until the goal dose for the     cohort is tolerated. The CAMPATH goal dose will be administered to the patient subcutaneously     (SQ) 3 times per week for up to 12 weeks.   "
174100|NCT00113061|"     The purpose of this study is to determine the effect of exercise training on elevated     C-reactive protein (CRP) concentrations, an indicator of inflammation, in initially inactive     women and men.   "
174101|NCT00113074|"     The purpose of this study is to develop effective interventions that assist individuals with     high blood pressure to quit smoking and prevent weight gain.   "
174102|NCT00113087|"     This study will evaluate the efficacy and safety of administering an angiotensin converting     enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle. The study     will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the     effect of ACE-I therapy to placebo on signs and symptoms of heart failure, neurodevelopmental     and functional status, ventricular geometry, function, and atrioventricular (AV) valve     regurgitation. In addition, the study will determine the relationship between genetic     polymorphisms linked to ventricular hypertrophy (enlarged heart) and the response to ACE-I     therapy and compare the incidence of adverse events in subjects treated with ACE-I with those     in subjects treated with placebo.   "
174103|NCT00113100|"     The purpose of this study is to investigate the way by which estrogen improves the appearance     of sun damaged human skin. Accumulating evidence suggests that estrogen, taken by post     menopausal women, may cause skin to look younger as a consequence of reduced wrinkles.     Collagen is the most abundant protein in human skin and gives skin its strength and shape.     Recent data indicate that short-term topical estrogen (17-beta estradiol) treatment increases     collagen production in sun damaged skin. This study will compare the molecular and     microscopic effects from topical 17-beta estradiol (E2) when applied to the skin for a     short-term duration. It is anticipated that the new knowledge from this study will enable     development of new ways to improve the function of aged skin.   "
174104|NCT00113113|"     Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to     define the maximum tolerated dose and the dose-limiting toxicity in this patient population,     and to perform pharmacokinetic studies of rubitecan in this patient population.   "
174105|NCT00113126|"     Treatment of HIV repairs the immune system, but continuous treatment is expensive and causes     side effects. Would it not be better to treat intermittently, e.g. stop treatment when the     immune system has recovered, and start again only when damage reappears? That is the question     which STACCATO proposes to answer.      Approximately 500 patients were recruited for this trial from 2002 to 2004. One third were     treated continuously; in two thirds, the treatment was interrupted whenever the CD4 count, a     measure of immune recovery, exceeded 350. At the end of 2005, the two treatment groups will     be compared in order to see which fared better regarding amount of drugs used, side effects,     CD4 counts, and development of resistance to treatment.   "
174106|NCT00113139|"     The purpose of this study is to examine the effectiveness of a telephone-based cognitive     behavioral therapy intervention to alleviate psychological distress among lung transplant     patients.   "
174121|NCT00113334|"     The goals of this clinical research study are to see how individuals with advanced head and     neck cancer respond to treatment with the new drug thrombospondin (ABT-510) and to learn how     effective it is in destroying cancer cells. The safety of ABT-510 and the effect ABT-510 has     on cells in the body will also be studied.   "
174122|NCT00113347|"     The goal of this clinical research study is to find the highest safe dose of the drugs     OSI-774 and docetaxel that can be given together along with radiation treatment for advanced     head and neck cancer.   "
174148|NCT00113685|"     The purpose of this study is to evaluate the clinical outcome of patients following blunt     traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or     hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic     outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory     cell responsiveness.   "
174149|NCT00113698|"     This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition     (ACE-I) therapy for the treatment of mitral regurgitation (MR).   "
174150|NCT00113711|"     To test whether a behavioral intervention could indeed achieve the dual goals of promoting     smoking cessation and minimizing weight gain.   "
174107|NCT00113152|"     This study will explore what may cause people with sickle cell anemia to have heart problems     and an increased risk of sudden death.      People 18 years of age and older with sickle cell anemia may be eligible for this study.     Candidates are screened with a medical history and physical examination, electrocardiogram     (EKG), echocardiogram (heart ultrasound), and blood tests.      Participants undergo the following tests and procedures:        -  Holter monitoring: The patient wears a small, battery-operated device to record heart          rate and rhythm over 24 to 48 hours.        -  QRST surface mapping: An EKG using 64 electrodes is done at rest and during exercise to          provide a detailed look at the heart and its conduction system.        -  Chest x-rays are taken to examine the lungs.        -  Bicycle exercise echocardiography test: Blood pressure, pulse, heart rhythm and oxygen          use are monitored while the patient exercises on a stationary bicycle. Ultrasound          pictures are also obtained during the exercise.        -  Echocardiogram: A heart ultrasound is done to check how well the heart is pumping blood.        -  Pulmonary artery catheterization: A catheter (plastic tube) is inserted into a vein and          advanced to the chambers of the heart, through the heart valve and into the lung artery.          The pressures in the heart and lung blood vessels are measured while the patient is          resting and during exercise, with the bed tilted up and down, and after giving 500 mls          of fluid into a vein.        -  Blood tests are done to measure a hormone called brain natriuretic peptide, which can          increase with the development of heart failure, and nitrite, a substance that can affect          blood vessel dilation. Some blood is stored to test for inflammatory markers and for          possible future gene and protein analysis.        -  Cardiac magnetic resonance imaging (cMRI): The patient lies in a donut-shaped magnet          while pictures of the heart are obtained using a magnetic field and radio waves.          Earplugs are worn to muffle the loud sounds that occur with electrical switching of the          magnetic fields. A contrast agent called gadolinium may be injected to enhance the          quality of the images.        -  Invasive electrocardiographic (reveal) monitoring: This procedure permits study of the          heart rhythms over a long time period. A small device is placed just under the skin on          the left side of the chest. It can be left in for up to 14 months to monitor the          heartbeat continuously during this time.   "
174108|NCT00113165|"     This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine)     extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release     is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but     do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets     will be added to current seizure treatments.   "
174109|NCT00113178|"     The purpose of this study is to evaluate the safety and efficacy of right atrial     intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial     flutter.   "
174110|NCT00113191|"     The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human     immune globulin intravenous (IGIV), can prevent an infection in the blood caused by     staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth.      Babies are enrolled between Day of Life 3 and 5. Babies are randomized to either Veronate or     placebo (50-50 chance of either). Babies can receive up to 4 doses of the study drug on Study     Days 1, 3, 8 and 15 and are followed until Study Day 70 or discharge from the hospital.   "
174111|NCT00113204|"     This is a phase 1 clinical trial to find the safe, maximum tolerated dose of IPI-504 in     patients with relapsed and/or relapsed, refractory multiple myeloma. This study will examine     how IPI-504 is absorbed, distributed, metabolized, and eliminated by the body. The study will     also evaluate potential anti-tumor activity of IPI-504.   "
174112|NCT00113217|"     The goal of this clinical research study is to learn if bevacizumab (Avastin®) can control     metastatic renal cell carcinoma (RCC). The safety of the treatment will also be studied.      Objectives:      Primary:        1. To assess the efficacy of neoadjuvant therapy of bevacizumab by evaluating time to          progression.        2. Toxicities of therapy with bevacizumab in RCC.      Secondary:      Clinical:        1. Response rate        2. Duration of response        3. Overall Survival      Preclinical:        1. Serum and plasma levels of matrix metalloproteinase 9 (MMP-9) and MMP-2, Interleukin 6          (IL-6), vascular endothelial growth factor (VEGF), and Basic Fibroblast Growth Factor          (bFGF) pre- and post- therapy (optional studies).        2. Tissue expression of Phospho-epidermal growth factor receptor (EGFR), VEGF, vessel count          CD31/34, AKT and Phospho-AKT, mitogen-activated protein kinase (MAPK), transforming          growth factor-alpha (TGF-alpha), phospho-STAT3 and TUNEL post therapy (optional          studies).        3. complementary DNA (cDNA) microarray analysis of tissue post-therapy (optional studies).        4. Tissue expression of tumor infiltrating lymphocytes and tumor antigens        5. Pathological response rate in primary tumor.        6. To evaluate the Single Nucleotide Polymorphisms (SNP) patterns in nephrectomy specimens          from patients participating in the study.   "
174113|NCT00113230|"     Preoperative chemoradiation leads to increased pelvic control and overall survival, but both     distant and local disease control remain problematic in locally advanced rectal cancer     patients. Enhancing the effect of chemotherapy and radiotherapy can increase tumor response     as well as distant disease control. Patients who have complete response to therapy have     increased sphincter preservation, and can possibly have more limited surgery (full thickness     local excision). When combined with standard chemotherapy, bevacizumab [RHUMAB VEGF, Avastin]     has been shown to improve response and median survival in patients with metastatic colorectal     cancer in a recent randomized trial, has led to increased activity in preclinical studies     with radiotherapy, and has been found to be very well tolerated with chemoradiation in a     phase I trial conducted at the M.D. Anderson Cancer Center (MDACC) in patients with locally     advanced pancreatic cancer. The hypothesis is that the addition of bevacizumab to standard     chemoradiation will safely lead to increased tumor response in patients with locally advanced     rectal cancer.   "
174114|NCT00113243|"     The purpose of this study is to determine if bone marrow derived adult stem cells are safe     and effective in inducing development of new blood vessels (angiogenesis) in the legs of     patients with severe peripheral vascular disease.   "
174115|NCT00113256|"     Patients will be treated with gemcitabine and Orathecin (rubitecan) capsules to evaluate the     current estimate of overall survival as a study endpoint prior to launching the blinded     randomized phase (versus gemcitabine and placebo) of the study. Toxicity of the drug     combination will also be evaluated.   "
174116|NCT00113269|"     The purpose of this study is to compare the safety and efficacy of different induction agents     (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients     treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.   "
174117|NCT00113282|"     Interleukin-2 (IL-2) increases the number of CD4 cells in HIV-1 infected patients with a CD4     cell count over 200/mm3, but its activity in patients with treatment failure and low CD4 cell     counts is unknown. This study will test the efficacy and safety of IL-2 with an optimized     antiretroviral regimen in patients with a CD4 count below 200/mm3 and a plasma viral load     above 10,000 HIV RNA copies/ml.   "
174118|NCT00113295|"     The purpose of this study is to examine the safety and efficacy of quetiapine for generalized     anxiety disorder patients who remain symptomatic despite treatment with paroxetine CR.   "
174123|NCT00113360|"     Objectives:      Primary endpoint:      -Assess the clinical activity of RAD 001 plus depot octreotide as defined by progression free     survival (PFS) duration defined by RECIST criteria in treated and untreated patients with     metastatic, unresectable low grade neuroendocrine carcinoma.      Secondary endpoints:        -  Assess the progression free survival duration of patients with metastatic, unresectable          low grade neuroendocrine carcinoma treated with RAD 001 plus depot octreotide.        -  Assess the safety of RAD 001 plus depot octreotide in patients with metastatic,          unresectable low grade neuroendocrine carcinoma.        -  To determine the expression/phosphorylation status of the components of the mTOR          signaling pathway in the primary tumors, in order to determine whether these markers can          be used as predictors of sensitivity to the combination of RAD001 and octreotide.        -  To determine the effect of the combination of RAD001 and octreotide on the expression          and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to          identify potential pharmacodynamics markers of response to this drug combination.        -  To observe the effects of treatment with RAD001 on plasma angiogenic biomarkers.   "
174124|NCT00113373|"     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. This phase II trial is studying how well lapatinib works in treating patients with     persistent or recurrent ovarian epithelial or peritoneal cancer.   "
174125|NCT00113386|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin and     docetaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug     (combination chemotherapy) together with radiation therapy before surgery may shrink the     tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that     remain after surgery. It is not yet known whether giving cisplatin and docetaxel together     with radiation therapy is more effective than giving cisplatin together with docetaxel in     treating non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying cisplatin, docetaxel, and radiation     therapy to see how well they work compared to cisplatin and docetaxel in treating patients     who are undergoing surgery for newly diagnosed stage III non-small cell lung cancer.   "
174126|NCT00113399|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more     sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and     giving them with radiation therapy may kill more tumor cells. It is not yet known whether     giving radiation therapy together with combination chemotherapy is more effective than giving     combination chemotherapy alone in treating head and neck cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy and combination     chemotherapy to see how well they work compared to combination chemotherapy alone in treating     patients with recurrent head and neck cancer that cannot be removed by surgery.   "
174127|NCT00113412|"     One measurement of an HIV infected person’s risk of progressing to AIDS is the number of     viral particles of HIV in their blood (called a “viral load”). In a previous phase I/II     study, SP01A was observed to significantly lower the amount of HIV in blood, improve quality     of life (how well subject's felt), have a favorable safety profile (minimal side effects),     and be well tolerated. Moreover, in in vitro testing SP01A: (1) demonstrated comparable or     greater efficacy than currently approved anti-HIV drugs in preventing HIV virus replication;     (2) was observed to have minimal toxic effect on human cells; and (3) demonstrated     significant efficacy in preventing virus replication of HIV virus strains that resist     currently approved anti-HIV treatments. Based on these results, SP01A demonstrates promise as     a new and novel anti-HIV treatment.      The goal of this study is to further look at the dose response, efficacy, and safety of SP01A     as monotherapy, given as a capsule to be swallowed, in the treatment of HIV-infected     subjects. The investigators want to see if SP01A will lower the amount of HIV in blood.      Subjects will be assigned by chance to 1 of 4 groups. Neither the subject nor the study     doctor or nurse will know which dose of the study drug the subject is taking or if the     subject is receiving the placebo (a capsule that looks like the study drug but does not     contain any active ingredient).      At the end of the 10-day study, the subject will be offered testing of their virus for     resistance to approved drugs (genotype) and transferred to their physician for continued     treatment with FDA-approved antiretroviral therapies. If the subject experiences a side     effect, which continues past the end of the study, they will be further monitored until the     side effect goes away.   "
174128|NCT00113425|"     The purpose of this research project is to study the effect of non-ablative (non-cutting)     laser therapy, a technique that uses laser energy to try to improve the appearance of the     skin. This type of laser treatment creates changes in a layer of the skin called the dermis     without causing an open wound in the skin. The use of non-ablative laser therapy, together     with application of a photo-sensitizer (substance that makes the skin more sensitive to     light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it     is supposed to make the laser more effective than using just the laser alone. It is not yet     clear how much improvement can be seen with these treatments or exactly how the skin's     response causes these improvements. In this study, we are interested in learning how well     such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer     actually enhances the efficacy of the laser.   "
174129|NCT00113438|"     This is a study evaluating the safety and effectiveness of Combretastatin A4 Phosphate (CA4P)     combined with the chemotherapy drugs, carboplatin and paclitaxel. The full treatment and     observation time should be about 5 months. During this time the patient should receive 18     CA4P infusions and 6 carboplatin followed by paclitaxel treatments. Patients will be     randomized into one of two CA4P dose-level groups in order to recommend a preferred     dose-level for future studies. At least 2 dynamic contrast enhanced-magnetic resonance     imaging (DCE-MRI) scans will be conducted to monitor the blood flow through the tumor before     and after treatment with CA4P.   "
174130|NCT00113451|"     The purpose of this study is to answer, among others, the following questions: 1) What are     the outcomes when using the radial artery as a bypass graft in coronary artery bypass surgery     (CABG)? 2) Can multidetector computed tomography (CT) be used to reliably evaluate coronary     artery bypass graft patency?   "
174171|NCT00113984|"     This study will evaluate the side effects of a fixed dose of vaccine and GM-CSF with     increasing doses of anti-CTLA-4 antibody in patients with advanced prostate cancer. The     vaccine consists of a priming vaccine called PROSTVAC/TRICOM, made from vaccinia virus, and     a boosting vaccine called PROSTVAC-F/TRICOM, made from fowlpox virus. GM-CSF is a chemical     that boosts the immune system, and anti-CTLA-4 antibody is a protein that may improve     anti-tumor activity and the response to the vaccines. DNA is inserted into the priming and     boosting vaccine viruses to cause production of proteins that enhance immune activity and     also to produce prostate specific antigen (PSA)-a protein that is normally produced by the     patient's tumor cells.      Patients 18 years of age and older with androgen-insensitive prostate cancer that has spread     beyond the original site may be eligible for this 7-month study. Candidates must have disease     that has worsened despite treatments with hormones and up to one chemotherapy regimen. Their     tumor must produce PSA, and they must have no history of allergy to eggs or egg products     Candidates are screened with a medical history and physical examination, blood and urine     tests, electrocardiogram, pathological confirmation of the diagnosis and presence of the PSA     marker, chest x-rays, imaging studies to assess the extent of tumor, and, if clinically     indicated, a cardiologic evaluation.      Participants receive the priming vaccination on study day 1. After 2 weeks and then again     every 4 weeks while on the study, they receive a boosting vaccine. All vaccines are injected     under the skin. On the day of each vaccination and daily for the next 3 days, patients     receive an injection of GM-CSF to increase the number of immune cells at the vaccination     site. On the day of the first six boosting vaccinations, they receive anti-CTLA-4 antibody as     an infusion through a vein over 90 minutes.      Patients are monitored for safety and treatment response with the following tests and     procedures:        -  Blood and urine tests monthly, or more often if needed, to monitor liver, kidney, and          other organ function.        -  Imaging studies to assess the tumor before starting treatment, again around study days          99 and 183, and then every 3 months after that while on study.        -  Apheresis (a procedure for collecting immune cells called lymphocytes) to measure the          immune response to treatment. Apheresis is done three times: before starting the study          and again around study days 99 and 183. For this procedure, blood is collected through a          needle in an arm vein. The blood circulates through a machine that separates it into its          components by spinning, and the lymphocytes are extracted. The rest of the blood is          returned to the patient through the same needle. This will only be done in participants          who have the tissue marker HLA-A2 (about 50% of patients).      Patients whose disease responds to treatment and who do not develop severe side effects may     continue treatment beyond the initial 7-month study period on vaccine alone (without the     antibody). After treatment is completed, patients are monitored for up to 15 years. This     includes a medical history and physical examination for 5 years following the last     vaccination. Information beyond 5 years is collected once a year by telephone.   "
174131|NCT00113464|"     This study will explore screening for immunodeficiency diseases (diseases that cause problems     in fighting infections). There is no method at present to screen all babies at birth for     immunodeficiency. However, babies with low numbers of T-cells-an important type of immune     system cell-may be found by studying T-cell products called TRECs (T-cell receptor excision     circles). This study will:        -  Collect samples from children with several different immunodeficiencies to find out          which disorders can be found by screening dried blood spots for TRECs.        -  Try to develop screening tests based on other kinds of material derived from dried blood          spots.      Children with primary immunodeficiency and low numbers of T cells who have not had a bone     marrow transplant may be eligible for this study.      Participating children donate up to 5 ml (1 teaspoon) of blood. The sample may be collected     when the child is having other blood tests. The liquid blood is analyzed to determine the     number of T cells, and the rest of the blood is used to make dried blood spots on filter     paper. The blood spots are used to develop screening tests for immunodeficiency. The blood     spots and data about the child's age, diagnosis, and current medicines will be kept coded by     diagnosis and a code number instead of the child's name.   "
174132|NCT00113477|"     The purpose of this study is to determine whether supplements of Q10 and Selen are effective     in reducing muscular adverse events (AE) in statin therapy.   "
174133|NCT00113490|"     The primary objective of this study was to determine the effect on immune reactivity to     motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524)     administered for a second season in children.   "
174134|NCT00113503|"     This study will compare two different dosing methods of azathioprine (IMURAN) in participants     with Crohn's disease who are currently taking steroids (e.g. prednisone or budesonide)or who     have just started steroids. The study can be up to 54 weeks long. All participants enrolled     will receive active drug. Participants will take doses either based upon weight or based on     the patient's ability to breakdown the drug (monitored by 6-thioguanine nucleotides (6-TGN)     metabolite levels in the blood). All patients enrolled in the study will receive active study     drug.   "
174135|NCT00113516|"     The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit     when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and     also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell     Lung Cancer (NSCLC).   "
174136|NCT00113529|"     To assess the maximum tolerated dose and overall safety and tolerability of sunitinib     [SU011248] administered in combination with gefitinib (Iressa) for the treatment of patients     with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the     combination of gefitinib and sunitinib (Phase 2).   "
174137|NCT00113542|"     Psoriasis is a common skin disease affecting an estimated 2.6% of the US population. It is a     chronic, recurrent condition for which there is no cure, but there are ways to control it.     Psoriasis is characterized by epidermal hyperplasia (abnormal increase in the number of     normal cells of the outer layer of the skin). Tetrathiomolybdate (TM), a copper chelator (a     drug that removes copper from the bloodstream) was first created to treat Wilson's disease, a     disorder caused by too much copper in the blood. Studies in animals have since shown that TM     may also prevent the formation of new blood vessels and may also block the key components of     inflammation (swelling, redness, and pain) caused by psoriasis. TM is not approved by the FDA     for any use yet. It is an investigational drug used for clinical research. We propose to test     whether a new treatment with TM can in fact improve or stabilize psoriasis.   "
174138|NCT00113555|"     The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive     surgical procedure in up to 160 implanted female patients in which two adjustable balloons     (one on each side of the urethra) are implanted to treat urinary stress incontinence.      The results will be analyzed to demonstrate the effects of the device as well as its     associated risks. Therapeutic success will be based on whether the patients demonstrate at     least a one-grade (mean) reduction in the Stamey score at 12 months.   "
174139|NCT00113568|"     The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual     bleeding associated with menorrhagia.   "
174140|NCT00113581|"     The main purpose of this study is to test the safety and tolerability and effectiveness of a     new treatment, EMD 72000 (matuzumab), for advanced oesophagogastric cancer in combination     with the chemotherapy regimen ECX (epirubicin, cisplatin and capecitabine).      In addition the study will look at pharmacokinetic (how the the body takes up the drug) and     pharmacodynamic parameters (what the drug does in the body).   "
174141|NCT00113594|"     The purpose of this study is to characterize olanzapine pharmacokinetics: the inter- and     intra- subject variabilities of olanzapine pharmacokinetics; and the potential influence of     patient factors such as age, weight, gender, origin, and smoking status on olanzapine     pharmacokinetics in adolescents with schizophrenia or bipolar I disorder. This study will     also assess the safety of olanzapine delivered orally.   "
174142|NCT00113607|"     The purpose of the study is to compare the progression-free survival (PFS) of the combination     of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.   "
174143|NCT00113620|"     The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine     are effective in the treatment of pain of diabetic neuropathy.   "
174144|NCT00113633|"     The study will assess the efficacy of a three-part Emergency Department (ED)-based Asthma     Belief and Control intervention on healthcare utilization, asthma controller medication use,     symptoms, and quality of life during the 6 months following an Emergency Department visit.   "
174145|NCT00113646|"     The purpose of this study is to determine if recipients of non-myeloablative ex-vivo T-cell     depleted peripheral blood (PBSC) stem cell transplantation using a mismatched related donor     will have less severe graft versus host disease (GVHD), transplant related mortality, and     less graft failure compared to alternative haploidentical stem cell transplantation.   "
174146|NCT00113659|"     The goal of the study is to understand the mechanisms of how antigen presentation affects the     developing immune system and subsequently affects susceptibility to, or protects against,     asthma development. This randomized controlled study will test the effectiveness of daily     supplementation of Lactobacillus GG for the first 6 months of life on the early immunological     development of asthma.   "
174147|NCT00113672|"     The purpose of this study is to examine the impact of diet and exercise on an individual's     health.   "
174156|NCT00113789|"     This trial will provide data on the safety and efficacy of pegfilgrastim, in terms of     duration of grade 4 neutropenia, when administered on the last day or the day after a     multi-day, myelosuppressive chemotherapy regimen for ovarian cancer.   "
174157|NCT00113802|"     The purpose of this study is to determine whether epratuzumab provides effective therapy in     Waldenström's Macroglobulinemia (WM).   "
174158|NCT00113815|"     The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate     in infants with refractory partial onset seizures (POS).   "
174159|NCT00113828|"     The purpose of this trial is to determine if patients with hematologic diseases who have a     HLA 6/6 matched related donor and are not eligible for a standard myeloablative stem cell     transplant will have less severe graft versus host disease (GVHD), transplant related     mortality, and less graft failure when treated with a non-myeloablative T-cell depleted stem     cell transplant.   "
174160|NCT00113841|"     Primary Objectives:        1. To evaluate clinical tolerance and response to curcumin alone and in combination with          Bioperine in patients with multiple myeloma.        2. To compare the pharmacokinetics and pharmacodynamics of curcumin and curcumin +          Bioperine and evaluate the effect of Bioperine on the bioavailability of curcumin.        3. To evaluate the biologic effects of curcumin alone and in combination with Bioperine on          the expression of NF-kB and related genes in the Multiple Myeloma (MM) cells.   "
174161|NCT00113854|"     Cerebral malaria is a life-threatening complication of Plasmodium falciparum infection in     African children and nonimmune travellers despite availability of quinine, the current drug     of choice. Several reports have suggested that raised intracranial pressure (ICP) is a major     cause of death among children with cerebral malaria. Mannitol, an osmotic diuretic,     effectively lowers ICP and is used to treat post traumatic raised ICP. There have been some     case reports of reduction in mortality and morbidity in African children with cerebral     malaria following administration of mannitol, but as these were not randomized controlled     trials it is difficult to evaluate their significance. This study seeks to establish whether     a single dose of intravenous mannitol given to children with cerebral malaria will     significantly reduce the coma recovery time.   "
174162|NCT00113867|"     The purpose of this study is to examine the effects of marked alterations in ovarian steroid     hormones on cognitive functions in women. Sex hormones and stress hormones of women awaiting     or undergoing in-vitro fertilization (IVF) will be compared with levels of women adopting     children and women on oral contraceptives.   "
174163|NCT00113880|"     The purpose of this study was to expand the data describing the safety profile of FluMist in     the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of     annual revaccination in those who received FluMist in 2 or more consecutive years.   "
174164|NCT00113893|"     The purpose of this study is to determine the safety and effectiveness of oral SCIO-469 in     patients with myelodysplastic syndromes. SCIO-469 belongs to a new class of treatments that     inhibit expression and activity of cytokines that play a role in the progression of MDS.   "
174165|NCT00113906|"     Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized     clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep     disturbances and general wellbeing.   "
174166|NCT00113919|"     The purpose of this study is to find out if patients with high risk disease because of age or     kidney status can be treated more safely with a drug called Busulfex® followed by autologous     transplant compared to treatment with the standard drug called melphalan, which has been     shown to be quite difficult to tolerate in patients with poor kidney function and patients     over the age of 65 when given in high doses.   "
174167|NCT00113932|"     The purpose of this study is to find out if treating multiple myeloma (MM) patients with more     intense chemotherapy and autologous transplant (high dose density therapy) early in the     disease course will result in better treatment outcomes compared to patients treated in the     past.   "
174168|NCT00113945|"     The purpose of this study is to observe the effects of a treatment strategy that incorporates     cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) in subjects with     ESRD receiving hemodialysis, on bio-intact parathyroid hormone (biPTH), corrected serum     calcium, serum phosphorus, and calcium phosphorus product.   "
174169|NCT00113958|"     The purpose of this study is to observe the effects of a treatment strategy that incorporates     cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) to K/DOQI     recommended targets in subjects with end stage renal disease (ESRD) receiving hemodialysis,     on bio-intact parathyroid hormone, corrected serum calcium, serum phosphorus, and calcium     phosphorus product.   "
174170|NCT00113971|"     The goal of this study is to evaluate how epratuzumab is processed by the body     (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in     patients with SLE.   "
174172|NCT00113997|"     This 1-week study will test the safety and dosing of an anticoagulation system called REG1     that is designed to improve control of blood thinning. Patients with heart attack and other     conditions require treatment with an anticoagulant (blood thinner) to prevent the formation     of blood clots. However, anticoagulation therapy can increase the risk of bleeding. The REG1     system is designed to minimize this risk. One part of the system stops the activity of factor     IX (a protein that helps blood clot) while the other part of the system (the antidote)     inactivates the drug and stops the thinning process. This study will examine in normal     healthy subjects how the REG1 system works in the body and how it leaves the body.      Healthy normal volunteers between 12 and 65 years of age who weigh 50-120 kilograms (110-264     pounds) and have no history of bleeding problems or significant bleeding may be eligible for     this study. Candidates are screened with a medical history, physical examination, and blood     tests.      Participants must avoid foods that may alter the blood's clotting ability and must not take     any medications the week of the study. They undergo the following tests and procedures:      Day 1      Subjects are admitted to the NIH Clinical Center for an overnight stay. Two catheters     (plastic tubes) are placed in the subject's arm veins, one for drawing blood samples and the     other for injecting one of the following: REG1 drug, REG1 antidote, REG1 drug and antidote,     or placebo. Two injections of study medication are given, spaced 3 hours apart, each over a     1-minute period. After each injection, blood is collected at specific times to measure levels     of the drug or antidote in the body and the blood's ability to clot. Subjects also provide a     24-hour urine collection and stool sample.      Day 2      A blood sample is drawn 24 hours after the drug or antidote injection from the previous day.     If the blood test result is normal, subjects are discharged home with instructions to follow.     They return to the Clinical Center at 36 hours and 48 hours for additional blood samples.      Days 3 and 7      A blood sample is collected at the end of day 3 and day 7. Urine and stool samples are also     collected.   "
174240|NCT00121732|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974     administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or     on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed     following effective therapy or for which no effective therapy exists.   "
174173|NCT00114010|"     This study will examine the safety and immune response of healthy adult volunteers to     AMA1-C1, an experimental malaria vaccine developed by the NIAID. Malaria affects about 300     million to 500 million people worldwide each year, causing from 2 million to 3 million     deaths. Increasing drug resistance to the malaria parasite, as well as widespread resistance     of mosquitoes (the insects that transmit the parasite) to pesticides are reducing the ability     to control malaria through these strategies. A vaccine that could reduce illness and death     from malaria would be a valuable new resource in the fight against this disease. Early tests     of AMA1-C1 in 66 people in the United States and in Mali, West Africa, found no serious side     effects of the vaccine. This study will test a shorter schedule of vaccinations with AMA1-C1     than that used in the previous studies.      Healthy volunteers between 18 and 50 years of age who weigh at least 110 pounds and with no     travel to malaria endemic areas in the past 12 months may be eligible for this study.     Candidates are screened with a medical history and physical examination, blood and urine     tests, and a urine pregnancy test for women who are able to bear children.      Participants are randomly assigned to receive three injections of either the experimental     malaria vaccine or a placebo (a solution that does not contain the vaccine) over a 2-month     period. The shots are given in an upper arm muscle, each 1 month apart. On the day of each     injection, participants give a history of symptoms since the last visit, have a brief     physical examination and blood test and, for women, a blood or urine pregnancy test. After     the injection, participants remain in the clinic 60 minutes for observation. In addition to     the injections, participants undergo the following procedures:        -  Record temperature and symptoms on a diary card daily for the first 7 days after each          injection.        -  Follow-up clinic visits 1, 3, 7 and 14 days after each shot to check for side effects.          Blood samples are drawn before each injection and at each return clinic visit to check          the safety and immune response to the vaccine.        -  Have apheresis, a special procedure that separates certain components of the blood, 7          days after each injection to measure the function of germ-fighting blood cells. For this          procedure, blood is drawn through a needle in an arm vein and directed into a machine          that separates the different types of blood cells. The white cells are collected in a          plastic ...   "
174174|NCT00114023|"     This is a 1-year follow-up study to evaluate the long-term effects in subjects who completely     cleared their actinic keratosis (AK) lesions in the 1473-IMIQ study. The 1473-IMIQ study     evaluated the safety and effectiveness of imiquimod 5% cream compared to a placebo cream for     the treatment of AK.   "
174175|NCT00114036|"     The specific aims are to determine the incidence of medication errors related to     antimicrobial prophylaxis for cardiovascular surgery, joint replacement surgery, and     hysterectomies across a heterogeneous sample of hospitals; identify organizational and     practitioner factors associated with error rates, and evaluate the effectiveness of a     multifaceted intervention in reducing prophylaxis error rates compared to written feedback     alone in a sample of 44 hospitals enrolled in the study using a rigorous group-randomized     design.   "
174176|NCT00114049|"     The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in     treating the signs and symptoms of dental pain following third molar tooth extraction.   "
174177|NCT00114062|"     The purpose of this study is to determine whether denufosol tetrasodium (INS37217)     Intravitreal Injection is well tolerated and has the potential to treat uveitis associated     macular edema.   "
174178|NCT00114075|"     The purpose of this study is to evaluate the effects of pre-operative gait analysis testing     on surgical outcomes in children with cerebral palsy who have problems walking.   "
174179|NCT00114088|"     STOP-DUB is a multicenter randomized clinical trial that is assessing the efficacy and     effectiveness of hysterectomy versus endometrial ablation (EA) for dysfunctional uterine     bleeding (DUB) in women for whom medical management has not provided relief.   "
174180|NCT00114101|"     This randomized phase III trial studies lenalidomide to see how well it works compared to a     placebo in treating patients with multiple myeloma who are undergoing autologous stem cell     transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any     cancer cells that are in the body and helps make room in the patient's bone marrow for new     blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the     patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for     the stem cell transplant. The stem cells are then returned to the patient to replace the     blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as     lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer     cells from growing. Giving lenalidomide after autologous stem cell transplant may be an     effective treatment for multiple myeloma.   "
174181|NCT00114114|"     The purpose of this study is to determine the levels of testosterone and/or estradiol at     which changes in bone turnover, body composition, strength, sexual function etc. begin to     occur. This information may help determine when to intervene with hormone replacement therapy     in aging men.   "
174182|NCT00114127|"     The purpose of this study is to examine the safety and efficacy of duloxetine for the     treatment of social anxiety disorder.   "
174183|NCT00114140|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together     with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation     therapy works in treating patients with low-grade gliomas.   "
174208|NCT00120874|"     The purpose of this study is to determine whether a comprehensive, individualized management     approach with caregiver training and medication with memantine will alleviate symptoms in     community dwelling patients with moderate to severe Alzheimer's disease.   "
174184|NCT00114153|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when     given together with carboplatin followed by radiation therapy in treating patients with stage     III or stage IV head and neck cancer.   "
174185|NCT00114166|"     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     topotecan in different dosing schedules may kill more tumor cells.      PURPOSE: This phase II trial is studying how well topotecan works in treating patients with     recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.   "
174236|NCT00121680|"     The purpose of this study is to study the safety of E7080 administered to patients with solid     tumors or lymphomas.      Please note: this study is now recruiting patients with advanced and/or metastatic melanoma     only.      In the current phase of this study, To determine the MTD and the pharmacokinetic profile of     E7080 when given as continuous daily (qd) dosing in combination with temozolomide.   "
174186|NCT00114179|"     Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of pancreatic cancer by blocking blood flow to the tumor. Radiation therapy uses     high-energy x-rays to kill tumor cells. Capecitabine may make tumor cells more sensitive to     radiation therapy. Bevacizumab may make tumor cells more sensitive to both chemotherapy and     radiation therapy. Giving chemotherapy and bevacizumab before and after radiation therapy may     kill more tumor cells. This phase II trial is studying how well giving capecitabine and     bevacizumab together with radiation therapy followed by gemcitabine and bevacizumab works in     treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.   "
174187|NCT00114192|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Thalidomide may stop the growth of non-small cell lung cancer by blocking blood flow to the     tumor. Thalidomide may also help docetaxel work better by making tumor cells more sensitive     to the drug. Giving docetaxel together with thalidomide may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel together with thalidomide     works as second-line therapy in treating patients with stage III or stage IV non-small cell     lung cancer.   "
174188|NCT00114205|"     RATIONALE: Giving drugs, such as docetaxel, directly into the pleura after surgery to drain     the pleural effusion may help keep fluid from building up again.      PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of     intrapleural docetaxel given after surgery in patients with malignant pleural effusion.   "
174189|NCT00114218|"     This phase II trial is studying how well giving gemcitabine together with docetaxel works in     treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy,     such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) may kill more tumor cells.   "
174190|NCT00114231|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and     oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be     removed.      PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin     together with radiation therapy works in treating patients who are undergoing surgery for     stage I rectal cancer.   "
174191|NCT00114244|"     This randomized phase II is studying how well giving sorafenib with or without gemcitabine     works in treating patients with metastatic pancreatic cancer. Sorafenib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood     flow to the tumor. Drugs used in chemotherapy, such as gemcitabine, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving sorafenib together with gemcitabine may kill more tumor cells.   "
174192|NCT00114257|"     This phase I trial is studying the side effects and best dose of decitabine and FR901228 in     treating patients with relapsed or refractory leukemia, myelodysplastic syndromes or     myeloproliferative disorders. Drugs used in chemotherapy, such as decitabine and FR901228,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. FR901228 may also stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving     decitabine together with FR901228 may kill more cancer cells.   "
174193|NCT00114270|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. Estrogen can cause the growth of breast cancer cells. Hormone therapy using     letrozole may prevent breast cancer by lowering the amount of estrogen the body makes.     Zoledronate may prevent bone loss caused by letrozole. Giving letrozole together with     zoledronate may prevent breast cancer and reduce bone loss.      PURPOSE: This randomized clinical trial is studying letrozole and zoledronate to see how well     they work compared to letrozole and placebo or placebo alone in treating healthy     postmenopausal women with high breast density.   "
174194|NCT00120692|"     The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia     Treatment (PSQ-AT) in female breast cancer patients treated with darbepoetin alfa or     recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.   "
174195|NCT00120705|"     The purpose of this study is to assess the ability of darbepoetin alfa to maintain hemoglobin     concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W).   "
174196|NCT00120718|"     The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects     vascular function in patients with atherosclerosis and hyperlipidemia.   "
174219|NCT00121017|"     The purpose of this study is to determine whether a simplified lopinavir/ritonavir-based     therapy will continue to keep the viral load at very low levels after initial treatment with     a combination of Kaletra (lopinavir/ritonavir) plus tenofovir and emtricitabine.   "
174209|NCT00120887|"     Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in     systemic lupus erythematosus (SLE) in developed countries. Coronary artery disease and stroke     contribute to long-term morbidity in surviving patients. Atherosclerosis in SLE is     multifactorial, with immune/inflammatory endothelial damage, traditional cardiovascular risk     factors, and prothrombotic factors all playing important roles. Multiple groups have shown     that hyperlipidemia is predictive of later atherosclerosis in SLE. In the general population,     statins have become the drug of choice in preventing atherosclerotic events, through two     mechanisms: lipid lowering that helps to prevent progression, and stabilization of plaques to     prevent rupture. In the Lupus Atherosclerosis Prevention Trial we will determine if     atorvastatin reduces the progression of atherosclerosis on helical computed tomography (CT)     and carotid duplex. Recent work has confirmed that statins have an immunomodulatory role.     This study will also determine whether statins improve clinical lupus activity or lupus     serologies (anti-dsDNA and complement).   "
174197|NCT00120731|"     High amounts of calcium in the urine (hypercalciuria) can cause development of kidney stones     in children. Treatment for these children includes plenty of fluids, a low-salt diet and     medications such as potassium citrate. A major advantage of potassium citrate, as compared to     hydrochlorothiazide, is its lack of side effects. One problem the researchers and others have     observed is that some children continue to form kidney stones despite correction of     hypercalciuria with potassium citrate. One possible explanation is that in some individuals     potassium citrate therapy results in an excessive elevation of urine pH, a situation that may     predispose to calcium phosphate stone formation. In this study, the researchers will study     the effects of potassium citrate on urine chemistries and acid-base balance in three groups     of children aged 5-17 years:        -  children who are hypercalciuric stone formers;        -  healthy children without a history of hypercalciuria or kidney stones.      Particular attention will be paid to try to identify those who develop a very high urine pH     (>8) and the factors leading to this metabolic reaction.      The researchers will try to learn whether it is the child’s characteristics, the disease     manifestations, the dose of the drug, or a combination of the above which may be the cause of     the development of very alkaline urine. Based on the results, the researchers hope to be able     to better “tailor” the individual treatment for each child with kidney stones.   "
174198|NCT00120744|"     The objectives of the study were to determine whether ondansetron treatment would reduce:        -  the amount of vomiting in the emergency department;        -  the need for intravenous rehydration; and        -  the need for hospitalization.   "
174199|NCT00120757|"     Osteopenia and osteoporosis are being described more frequently in people with HIV infection.     This study will test the efficacy of alendronate in comparison with a placebo after 2 years,     in people with primary osteoporosis. People will receive the recommended adequate intake of     calcium and vitamin D.   "
174200|NCT00120770|"     This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the     effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of     HIV infection.   "
174201|NCT00120783|"     This study investigated whether a calibrated reduction in antiretroviral drug pressures could     stabilize the evolution and the pathogenic potential of resistant HIV viruses.   "
174202|NCT00120796|"     Chronic hepatitis B infection is a major public health issue in Senegal. The study will     compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine     (12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on     the control of viral replication in patients with a replicative hepatitis B virus (HBV)     infection and an increase in hepatic enzymes.   "
174203|NCT00120809|"     Malaria is particularly harmful during pregnancy causing anemia in the mother and low birth     weight which, in turn, increases infant mortality. Thus, the World Health Organization (WHO)     now recommends that all pregnant women who live in malaria endemic areas of Africa should     receive sulfadoxine-pyrimethamine (SP) at monthly intervals during the second and third     trimesters of pregnancy. Malaria is especially severe during first pregnancies and the value     of intermittent preventative treatment with SP during first pregnancies has been clearly     shown. However, it is less certain whether multigravidae, who are at less risk, also benefit     from intermittent preventative treatment with SP. To investigate this, a trial has been     conducted in Gambian multigravidae who were given intermittent preventative treatment with SP     or placebo during the second and third trimesters. The prevalence of anemia six weeks after     delivery, low birth weight and poor outcome of pregnancy in women in each group were studied.   "
174204|NCT00120822|"     Supplementation with folic acid and iron is recommended for pregnant women in order to     prevent them from developing anemia. In malaria endemic areas of Africa, the World Health     Organization (WHO) now recommends that pregnant women should also be given     sulfadoxine-pyrimethamine (SP) once a month after quickening to protect them against malaria     which is especially harmful during pregnancy. However, folic acid is an antagonist of SP so     there is a possibility that giving folic acid with SP could interfere with the ability of the     latter to provide protection against malaria. To investigate this possibility Gambian     primigravidae with malaria parasitemia have been given SP and folic acid at the same time or     on separate occasions two weeks apart and the ability of SP to cure the malaria infection     investigated.   "
174205|NCT00120835|"     This study is being conducted in treatment-naive patients (no previous hepatitis C treatment)     to evaluate the safety of valopicitabine (NM283) alone and together with pegylated     interferon, a drug approved by the Food and Drug Administration for the treatment of     hepatitis C infection. This study is also evaluating the ability of valopicitabine to     decrease the amount of hepatitis C virus in the body. The results for patients taking     valopicitabine alone will be compared with the results for patients taking valopicitabine     together with pegylated interferon.   "
174206|NCT00120848|"     Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and     genitals in men and women. Several types of HPV infection are transmitted by sexual activity     and, in women, can infect the cervix (part of the uterus or womb). This infection often goes     away by itself, but if it does not go away (this is called persistent infection), it can lead     in women over a long period of time to cancer of the cervix. If a woman is not infected by     HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow     up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV     infection. The current study invites all of the 1113 subjects in the HPV-001 study that     received all three doses of vaccine/placebo to be enrolled and followed-up for several     additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to     evaluate the safety of the vaccine. Subjects will remain in the same study group as in the     primary study. No vaccine or placebo will be administered in this study.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
174207|NCT00120861|"     This study is being conducted to compare the safety, effectiveness and tolerance of     valopicitabine (NM283) when used alone and when valopicitabine is used together with     pegylated interferon in hepatitis C treatment failure patients. These results will be     compared against the results of treatment with pegylated interferon plus ribavirin, the     current standard therapy for treatment of hepatitis C viral infection.   "
174220|NCT00121459|"     The purpose of this trial is to determine whether using the diaphragm and a lubricant get can     reduce women's risk of acquiring an HIV infection.   "
174211|NCT00120913|"     While there may be a decrease in the total number of bleeding days women experience with     continuous-dosed COCs (no menstrual withdrawal week), these regimens frequently result in an     increased number of “breakthrough” or non-scheduled bleeding days. Breakthrough bleeding is     among the main reasons cited for discontinuation of combined COCs dosed traditionally (3     weeks of active pill, 1 week of placebo) or continuously, and may offset the perceived     benefit of fewer withdrawal bleeding events for many women taking continuous-dosed COCs. The     exact mechanisms responsible for breakthrough bleeding patterns during hormonal contraception     are unknown and may be related to the pill formulation. This study is to determine whether     progestin type or estrogen dose influences bleeding patterns, side effects, or satisfaction     with combined oral contraceptives (COC) dosed continuously.   "
174212|NCT00120926|"     Malnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate     that prematurely born neonates commonly develop a severe nutritional deficit during the first     weeks after birth, referred to as extrauterine growth restriction. Despite an increase in     growth during the second month of hospitalization, many neonates are ultimately discharged     home having grown inadequately. The early nutritional deficit affects weight gain as well as     growth in length and head circumference.      Growth measurements such as weight, length, and head circumference, however, are macroscopic     measures of nutritional status and underestimate the physiologic consequences of prolonged     nutritional deprivation. Energy and micronutrient deficiencies alter growth at a cellular and     tissue level before macroscopic measures are altered. In the brain, for instance, energy is     required for cell division and neuronal growth, glial cell function, and myelination. Energy     deprivation may consequently alter neuronal function and growth, resulting in adverse     neurodevelopmental outcomes.      Immunocompetence also appears to be sensitive to the untoward effects of energy and     nutritional deficiency. Malnourished neonates often exhibit immune deficiencies related to     inadequate protein intake that compound an already immature immune system. Such     immunodeficiency results in susceptibility to infectious agents that creates substantial     morbidity and mortality to the course of intensive care for premature infants.      A recent study suggests that postnatal malnutrition and growth restriction are inevitable if     current recommended dietary intakes are followed. Multicenter studies show that variation in     dietary intake accounts for 45% of the variation in growth. Hence, efforts have focused on     determining whether nutritional deficiency and the observed growth restriction of premature     infants can be prevented through the use of more optimal nutritional intake. In addition,     inadequate protein support may be a primary cause for growth failure.      Based on animal studies showing high in utero amino acid flux observed during the latter     phase of gestation, Thureen et al have suggested the use of higher doses of amino acid     supplementation in order to minimize growth restriction and improve outcomes of premature     infants. However there are no large human trials that demonstrate that this approach promotes     better growth or that it is safe. While small doses of amino acids may be inadequate to     promote normal growth, high doses may lead to elevated serum amino acid levels and increase     the occurrence of toxicity. Through the implementation of a multicenter, randomized trial and     tandem mass spectrometry, the investigators propose to evaluate the effects of two distinct     strategies of amino acid supplementation on serum amino acid profiles and growth of premature     infants during the first 28 days of life.   "
174213|NCT00120939|"     The primary purpose of this study is to evaluate the safety, side effects, and dosage for     Motexafin Gadolinium given with the chemotherapy drug docetaxel to patients with advanced     cancers. Secondly, tumor response to the combined treatment, drug levels in the body, and     drug interactions will be evaluated.   "
174214|NCT00120952|"     In this randomised study, the migration of a specific cemented titanium femoral stem will be     compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric     analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated     to point out any interference from the modulus of the stem investigated.   "
174215|NCT00120965|"     The AutoPulse Assisted Prehospital International Resuscitation (ASPIRE) Trial compares the     efficacy of circulatory assist by manual chest compression versus an automated chest     compression device (AutoPulse™) during the resuscitative attempt following out-of-hospital     cardiac arrest.   "
174216|NCT00120978|"     Large population-based studies suggest that patients with chronic obstructive pulmonary     disease (COPD) are 2 to 3 times at risk for cardiovascular mortality, which accounts for a     large proportion of the total number of deaths. How COPD increases the risk of poor     cardiovascular outcomes is largely unknown. However, there is growing evidence that     persistent low-grade systemic inflammation is present in COPD and that this may contribute to     the pathogenesis of atherosclerosis and cardiovascular disease among COPD patients.     Inflammation and more specifically, C-reactive protein (CRP), has been linked with all stages     of atherosclerosis, including plaque genesis, rupture and subsequent thrombo-fibrosis of     vulnerable vessels. Recently, our group has demonstrated in a relatively small study that     short-term inhaled corticosteroid (ICS) therapy can repress serum CRP levels in stable COPD     patients. Conversely, withdrawal of ICS leads to a marked increase in serum CRP levels.     Although very promising, these data cannot be considered definitive because the study was     small in size and scope (N=41 patients). Additionally, this study did not address the     potential effects of combination therapy with ICS and long-acting β2 agonists (LABA). This is     an important short-coming because combination therapy of ICS and LABA have been shown to     produce improved clinical outcomes over ICS monotherapy and is commonly used by clinicians in     the treatment of moderate to severe COPD. We hypothesize that inhaled fluticasone (Flovent®)     reduces systemic inflammation and that combination therapy (Advair®) is more effective than     steroids alone in reducing systemic inflammation in COPD. In this proposal, we will implement     a randomized controlled trial to determine whether ICS by themselves or in combination with     LABAs can:        1. reduce CRP levels in stable COPD patients and        2. reduce other pro-inflammatory cytokines, which have been linked with cardiovascular          morbidity and mortality such as interleukin-6 (IL-6) and monocyte chemoattractant          protein-1 (MCP-1)   "
174217|NCT00120991|"     There is evidence linking cardiopulmonary bypass to negative side effects when used for     coronary artery bypass grafting. Coronary artery bypass grafting can be performed without the     use of cardiopulmonary bypass. The purpose of this study is to determine the positive and     negative effects of coronary artery bypass grafting with or without the use of     cardiopulmonary bypass. The patients will be followed at least one year after surgery.   "
174218|NCT00121004|"     In this study, hospitalized patients will first be surveyed regarding their interest in a     traditional advanced directive (AD) and then in a modified AD.   "
174221|NCT00121472|"     The purpose of this study is to determine the safety and effectiveness of the Thoratec     HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in     end-stage heart failure patients who are listed for cardiac transplant but are at imminent     risk of dying.      The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac     transplantation (reference PMA P060040). It was approved for commercial distribution in     Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the     clinical trial will continue to be followed until all have reached a clinical outcome.   "
174222|NCT00121485|"     The purpose of this study is to determine the safety and effectiveness of the Thoratec     HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart     failure patients who do not qualify for cardiac transplantation.      The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA     P060040/S005).   "
174237|NCT00121693|"     The purpose of this study is to determine whether listening to music will demonstrate changes     in human postural stability and whether those changes might be useful in fall prevention     strategies.   "
174238|NCT00121706|"     The primary aim of the proposed pilot study is to assess the effects of fast food meals,     varying in serving size and rate of delivery, on energy (calorie) intake in adolescents.   "
174223|NCT00121498|"     Preemptive analgesia is defined as “analgesic intervention provided before surgery to prevent     or reduce subsequent pain”. By preventing central sensitization using nociceptive blockers by     regional analgesia we may able to produce a painless postsurgical state. The use of     preemptive analgesia was reported in various surgical procedures, such as in limb surgeries,     laparoscopic procedures, mastectomy and vaginal hysterectomy. Regarding abdominal     hysterectomy there are only few reports, however both, malignancies and benign cases were     included and conflicting results were obtained regarding the value of preemptive analgesia.     Since hysterectomy is the most frequent major surgical procedure performed in gynecology, and     it is estimated that by age 64 years, 40 % of women will have had a hysterectomy, it would be     of great value to optimize pain treatment in these patients.      The aim of the present study was to evaluate the effectiveness of preemptive analgesia in     women who undergo a transabdominal hysterectomy for benign uterine abnormalities.      Hypothesis: Lidocaine (5%) injection to the scar area before incision is effective in pain     reduction among women who undergo a transabdominal hysterectomy for benign uterine     abnormalities .   "
174224|NCT00121511|"     The researchers propose that skin improvements may be seen following a course of Efudex,     (5-fluorouracil), a FDA-approved topical therapy (applied directly to the skin). These     improvements could be the result of both a reduction of actinic keratoses (small red horny     growths or flesh-colored wartlike growths caused by overexposure to ultraviolet radiation or     the sun) and improvement of sun-damaged skin.      In addition, this research study is being done to determine if the expression of p53, a tumor     suppressor gene (its activity stops the formation of tumors), is decreased following Efudex     treatment. Mutations (abnormal changes) in the gene, called p53, are associated with a     certain type of skin cancer. In addition, p53-mutated genes are known to exist in     non-cancerous sun-damaged skin. Thus, the presence of p53 mutations may serve as a marker for     both sun damage and an elevated risk of developing skin cancer.   "
174225|NCT00121524|"     Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation     since the start. It improves outcome in animal studies, but has never been investigated in a     controlled study in humans. Epidemiologic data indicate that it is an independent negative     predictor for survival. If this is true in a controlled randomized study, it could be due to     effects of the drug itself or more likely due to reduced quality of chest compressions and     ventilations due to the time spent on placing an I.V. needle and injecting drugs.   "
174226|NCT00121537|"     The purpose of this study is to look at the use of the wound vacuum assisted closure (VAC)     versus standard wet to dry dressing in treating lower leg fasciotomies.   "
174227|NCT00121550|"     A growing body of evidence links Chlamydia pneumoniae to the progression of coronary heart     disease. The purpose of this study is to determine the positive and negative effect of 14     days treatment with clarithromycin 500 mg daily in patients already suffering from stable     coronary heart disease. The participants will be followed for at least two years after the     treatment.      Abbott Laboratories supplied Clarithromycin and placebo tablets.   "
174228|NCT00121563|"     This study will evaluate the role of thalidomide, a tumor necrosis factor (TNF)-alpha     modulator, on severe inflammation and relief of pain following extraction of wisdom teeth.     TNFs are substances that affect the pathways of pain. This study involves an experimental     group in which patients will be given thalidomide or a placebo (an inactive substance); a     negative control group receiving the medication diazepam or a placebo; and a positive control     group receiving diazepam or ibuprofen.      Patients who are males ages 16 to 35, who are not allergic to aspirin or other nonsteroidal     anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics, and who in good     health may be eligible for this study. Females are not eligible, owing to the risks that     thalidomide presents to unborn children. To minimize the risk of fetal malformations, male     patients who participate must use a condom during sexual intercourse for 4 weeks following     the study and must not donate blood for 4 weeks.      The medications used in the study will be given 1 hour before surgery. Then after the wisdom     teeth are removed, a small piece of tubing will be placed into both sides of the patient's     mouth where the teeth were removed. Every 20 minutes, for the next 6 hours, the researchers     will collect inflammatory fluid from the tubing, to measure for changes in anti-inflammatory     action. If they request pain relievers, patients will receive the medication ketorolac     (Toradol), used for short-term treatment of moderately severe acute pain. Side effects of     thalidomide include fatigue, dizziness, and rash. The use of ibuprofen and ketorolac may     include the risk of gastrointestinal ulcers and bleeding. Diazepam can cause involuntary     muscle movements and drowsiness, as well as dizziness lasting for up to 24 hours after it has     been used as sedation. Patients will be instructed not to try to walk alone or to try to     drive a vehicle during that period. Other risks related to participation in this study     include those usually experienced with removal of wisdom teeth-that is, pain and swelling,     bruising from insertion of the sedative into a vein (if needed), possible infection at the     extraction site, prolonged bleeding, and numbness.      Benefits from participating are having wisdom teeth removed at no cost as well as close     monitoring before and after surgery. Results from the study may help people in the future by     improving the management of pain following surgery.   "
174229|NCT00121589|"     This study will explore whether taking the vitamins lutein and zeaxanthin, with or without     Omega-3 fatty acid (fish oil or docosahexanoic acid, also known as DHA) will change the     amount of lutein and zeaxanthin in the blood among people with age-related macular     degeneration (AMD). AMD is one of the leading causes of legal blindness among people over the     age of 50 in developed countries. In the disease, the retina of the eye, the sensory portion,     worsens in condition. AMD causes progressive loss of central vision, with only peripheral     vision remaining, that is, the ability for someone to see from the edges of the eye. To date,     there is not any effective treatment to improve vision for most people whose AMD is advanced.     Yet some data from research studies suggest a possible role of antioxidants, including     lutein, in reducing the risk of AMD and cataracts. Lutein and zeaxanthin belong to the     carotenoid family of vitamins, of which there are more than 600. There are 40 or 50     carotenoids in the typical diet of human beings, but only 14 major dietary ones are     identified in human plasma. Lutein, in particular, is a vitamin that is found naturally in     the retina, especially in the macula, the region of the eye that is essential for fine,     detailed vision. Previous studies have shown that higher levels of foods rich in Omega-3     fatty acid were associated with a lower likelihood of AMD.      Patients ages 60 and older who may or may not have AMD, who do not have certain other serious     eye disorders, and who have not had potentially life-threatening illness in the last year may     be eligible for this study. About 40 people will participate.      Patients will undergo a medical history and physical examination. A blood collection of about     4 tablespoons will be done to measure the amount of lutein and other vitamins in the blood.     Patients will have a complete eye examination consisting of procedures standard to those     given by ophthalmologists. Participants will have photographs taken of their eyes, and they     will undergo a visual field test. Flicker photometry also will be conducted. This consists of     the patients looking at a flashing bluish light with one eye at a time, and turning a knob     until the light stops flashing. Then during the test, patients will look away from the light     and turn the knob until the flashing stops.      During this study study, patients will be asked to not take more than two tablets each day of     multivitamins that contain lutein. The vitamin supplements will be provided as pills that     represent one of two vitamin regimens given on a random basis: either lutein and zeaxanthin     with DHA or lutein and zeaxanthin without DHA added. The amounts would be 10 mg/day of lutein     and 2 mg/day of zeaxanthin, with or without 1 g/day of DHA. Patients will return to the study     center for follow-up visits at 1 month, 3 months, 6 months, and 9 months. During those     visits, some of the examinations done earlier will be repeated so that the researchers can     evaluate the effects of supplements on patients' eyes. Patients will also be watched for     possible side effects from the vitamins supplements. Lutein and zeaxanthin supplements are     considered to be safe with possible minor side effects, such as headaches and difficulty in     swallowing the tablets. Fish oil or DHA supplements may also cause abdominal discomfort.      If information obtained from this study may be important for participants' health, they will     be informed when it is available. There are no plans to give participants the results of any     medical tests, evaluations, or other research data. Further research may be necessary before     such results become meaningful.   "
174230|NCT00121602|"     The purpose of this study is to evaluate whether the efficacy of darbepoetin alfa SF is     equivalent to that of darbepoetin alfa RB for the treatment of anemia in patients with     chronic kidney disease (CKD) receiving hemodialysis.   "
174231|NCT00121615|"     The objective of the study is to describe the safety, tolerability, and efficacy of the     long-term administration of etanercept in adults with psoriasis who have completed etanercept     psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension.     Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004.     Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.   "
174232|NCT00121628|"     The purpose of the study is to determine if AMG 706 will have clinically meaningful     anti-tumor activity in subjects with locally advanced or metastatic thyroid cancer who are     not candidates for radioactive iodine therapy or local therapies.   "
174233|NCT00121641|"     The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is     more effective than placebo as a treatment for type 2 diabetic subjects who are not     sufficiently controlled with diet and exercise   "
174234|NCT00121654|"     The study aims at assessing safety and efficacy of Spinal Cord Stimulation (SCS) for the     treatment of refractory angina pectoris in a single blind, prospective, multicenter study.      Sixty patients with refractory angina with new SCS device implantation will be randomized to     one of three treatment groups:        -  paresthesic SCS;        -  subliminal SCS;        -  low (non effective) stimulation (control).      Clinical follow-up will be done at 1 and 3 months. Control group patients will then be     randomized to paresthesic SCS or subliminal SCS for another 3 months and the 2 groups will be     reassessed at 6 months.   "
174235|NCT00121667|"     The purpose of this clinical research study is to learn whether Saxagliptin added to     Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic     subjects who are not sufficiently controlled with Metformin alone   "
174241|NCT00121745|"     This is a dose-seeking study that will test the safety of increasing doses of Rexin-G, given     intravenously, in patients with advanced or metastatic pancreatic cancer who have failed     standard chemotherapy. Rexin-G is a tumor-targeted gene therapy vector that contains a     killer gene that blocks the action of the human cyclin G1 gene. Cyclin G1 is a cell cycle     control element that plays an important role in cancer growth. When injected into a vein, the     Rexin-GTM vector seeks out and accumulates in cancerous tumors, therefore, increasing the     concentration of the drug in the cancerous tumors and not in normal neighbouring organs.   "
174242|NCT00121758|"     This study will test the safety and immune response to an experimental HIV vaccine, LIPO-5,     in healthy volunteers. LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to     more than 50 epitopes. LIPO-5 has been shown to be immunogenic and well tolerated in a first     phase I trial in non-HIV infected volunteers. Lower doses of each peptide could have a     similar immunogenicity.   "
174243|NCT00121771|"     Animal and human studies have shown that the prime-boost immunization strategy using malaria     antigens expressed in plasmid or viral vectors induces strong cellular immune responses. An     immunization regimen with the malaria vaccines DNA ME-TRAP followed by MVA ME-TRAP induced     strong T cell responses in adults in the United Kingdom (UK) and in the Gambia but did not     provide significant clinical protection against infection. The investigators assessed two new     vaccines which utilize a similar immunization strategy but a different malaria antigen, a     circumsporozoite (CS) protein. The entire CS protein was expressed either in a modified     vaccinia virus Ankara (MVA) CS, or an attenuated fowlpox virus strain (FP9) CS.   "
174244|NCT00121784|"     Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will     enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be     randomized to either continue this regimen or CNI therapy will be discontinued and replaced     by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2     regimens on efficacy, safety and renal function will be evaluated.The anticipated time on     study treatment is 1-2 years and the target sample size is 500+ individuals.   "
174245|NCT00121797|"     In the last years urinary tract infections (UTI) and pyelonephritis have been the most common     reason for readmission to our hospital after birth. UTI is know to be one of the leading     causes of postpartum fever affecting about 3%-8% of all postpartum women.      The investigators hypothesize that collecting urine cultures pre- and postnatally may help     identify women at risk for developing UTI, while treating women with positive cultures could     decrease the rehospitalization rate due to postpartum fever. Collecting data during delivery     may help identify women at risk for this complication.   "
174246|NCT00121810|"     This 2-arm study recruited kidney transplant patients who were receiving standard care of     calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily)     and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was     discontinued and replaced by sirolimus therapy (in combination with CellCept and     corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was     evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size     was 100-500 individuals.   "
174247|NCT00121823|"     The ability to test candidate pre-erythrocytic stage malaria vaccines, using a     well-established sporozoite challenge model, in a field setting with group sizes of tens     rather than hundreds of volunteers would greatly facilitate identification of the most     promising vaccine candidates. The investigators assessed the suitability and acceptability of     this method in a field trial in semi-immune volunteers exposed to natural infection during     the high malaria transmission season.   "
174248|NCT00121836|"     This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus     intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients     received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg     intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was     until disease progression or unacceptable toxicity. The target sample size was <100     individuals.   "
174251|NCT00121875|"     Growth hormone treatment improves body fat distribution but also causes insulin resistance.     Scientists have recently linked insulin resistance with special stores of fat in the muscles,     which can be measured by magnetic resonance imaging (MRI). The researchers hypothesize that     growth hormone will paradoxically reverse the linkage between muscle fat stores and insulin     resistance. To assess this association and to investigate the cause(s), the researchers will     measure muscle fat stores during growth hormone treatment. Other parameters linked to insulin     resistance (glucose tolerance, blood markers, and body composition) will also be assessed.     This study may lead to improved strategies for monitoring growth hormone therapy.   "
174252|NCT00121888|"     The purpose of the study is to evaluate the effectiveness and tolerability of     controlled-release paroxetine (Paxil-CR) compared to placebo (an inactive substance) for     individuals who continue to have symptoms of post traumatic stress disorder (PTSD) despite     receiving prolonged exposure therapy.   "
174253|NCT00121901|"     Post-ERCP pancreatitis can be a serious complication to ERCP. Two studies have shown a     promising preventive effect of glyceryl nitrate. This study should provide a final answer to     the clinical question: Does glyceryl nitrate prevent post-ERCP pancreatitis? The study is a     prospective, randomized, double blind, placebo-controlled multicenter trial. The     investigators intend to include 1600 patients from Norway, Sweden, Denmark, and France.      The patients will receive either placebo or a glyceryl nitrate patch (15 mg/24 hours).     Follow-up will occur after 7 days. The primary outcome measure will be post-ERCP     pancreatitis, and secondary outcome measures will be mild, moderate and severe pancreatitis;     post procedure pancreatitis-related mortality; and adverse events.   "
174254|NCT00121914|"     Hepatocellular carcinoma (HCC) is a consequence of liver cirrhosis. In early tumour stages,     tumour resection or liver transplantation are therapeutic options; later tumour stages may be     treated with locally ablative treatments such as percutaneous ethanol instillation (PEI),     transarterial chemoembolization (TACE) or radio-frequency thermoablation. This randomized     study investigates the effect of PEI on survival of patients with HCC. All patients will     receive hormonal treatment (long-acting somatostatin intramuscularly [i.m.]) and will be     randomized for treatment with PEI or no additional treatment.   "
174255|NCT00121927|"     This is a prospective study to determine whether the Atkins diet reduces seizures, creates     ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be     enrolled, expecting 20 to complete the 6-month study. The investigators plan to establish the     seizure baseline and type, initiate the Atkins diet, then monitor its administration in terms     of seizure reduction, ketosis, and side effects for a 6-month period.   "
174256|NCT00121940|"     The purpose of the study is to evaluate the effect of a Guided Care nurse on the quality of     the health and well-being of the frail elderly. A specially trained registered nurse will     work closely with 1-3 primary care physicians to provide the most complex older patients (and     their unpaid caregivers) with health care that is comprehensive, coordinated,     patient-centered, and proactive. The study will evaluate the effects of Guided Care on:        -  older persons' physical and mental health, health services utilization, quality of care,          self-efficacy, and satisfaction with care;        -  older persons' unpaid caregivers' burden; and        -  primary care physicians' satisfaction with their care of chronically ill patients.   "
174257|NCT00121953|"     The purpose of this study is to compare the effect of rosiglitazone versus placebo on soluble     proinflammatory markers in peritoneal fluid of women with endometriosis.   "
174258|NCT00121966|"     The primary objective of this study is:        -  To investigate whether insulin aspart with meals is better than a standard treatment          with insulin NPH at bedtime, evaluated by HbA1c.      The secondary objectives of this study are:        -  To study if a combination treatment with metformin and/or rosiglitazone and insulin          aspart with meals is better than a standard treatment with insulin NPH combined with one          or more of the above oral antidiabetic drugs. According to the hypothesis, special focus          will be given to the treatment group with insulin aspart combined with metformin and          rosiglitazone. The treatment effect will be evaluated by HbA1c.        -  To examine the effects of the treatments on glucose metabolism and beta cell function,          evaluated by diurnal blood glucose, fasting plasma glucose, insulin, C-peptide, and          lactate.        -  To examine the effects of the treatments on cardiovascular risk factors evaluated by          serum lipid profiles, serum free fatty acids, urine albumin/creatinine ratio, and          electrocardiogram (ECG).        -  To quantify and describe the patients' subjective experiences of the two different          insulin treatments (quality of life assessment)        -  To examine patients with type 2 diabetes for the presence of variability in a series of          genes, which are known to or are assumed to:             -  affect the long term outcome;             -  determine the responsiveness to treatment with diet, exercise and drugs targeting               the known risk markers for late diabetic complications; and             -  after intervention, to analyse the complex interrelationships between genotypes and               clinical endpoints and the responsiveness to actual treatment modalities.   "
174259|NCT00121979|"     Racivir ® (RCV) is an experimental drug which means it is not approved for use by the United     States Food and Drug Administration (FDA), but it can be used in research studies like this     one. RCV (Racivir®) is part of a class of drugs known as Nucleoside Reverse Transcriptase     Inhibitors (NRTIs), which are intended to block a further increase in the amount of HIV     virus in the body. Laboratory research suggests that RCV (Racivir®) may be effective in     patients who have developed resistance to other NRTIs, particularly 3TC (lamivudine,     Epivir®). However, a study of RCV (Racivir®) has not been done with patients who have     previously been treated with other HAART (Highly Active Antiretroviral Therapy -- taking     multiple HIV drugs at once) medications including 3TC (lamivudine, Epivir®).      The purpose of this study is to evaluate the safety and effectiveness of RCV (Racivir®) when     used together with other HIV drugs in people who have previously been treated with 3TC     (lamivudine, Epivir®) and are failing with their current HAART treatments. This study will     include a total of 60 HIV infected, HAART-experienced subjects currently receiving 3TC     (lamivudine, Epivir®) as part of their HAART therapy. The study will take place at     approximately 11 study sites in the US and Latin America.   "
174342|NCT00123084|"     The purpose of the research study is to determine the effects of two different kinds of     speech treatment on certain behaviors in individuals with parkinson's disease. These     behaviors include speech, voice, related communication behaviors, swallowing and body     movement.   "
174260|NCT00121992|"     This is a prospective, non-blinded randomized phase III trial. Patients will be     post-surgically stratified at inclusion first according to the participating institution,     then according to menopausal status and will be randomly assigned to receive either:        -  TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks          (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500          mg/m2 as an i.v. bolus on day 1 every 3 weeks.        -  FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination          with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v.          bolus on day 1 every 3 weeks.   "
174261|NCT00122005|"     Androgen (a male sex hormone) deprivation is the standard therapy for metastatic prostate     cancer and results in regression or control of disease in 80-85% of patients. This hormone     therapy results in a progression-free survival of 12-18 months and overall survival of 24-30     months. However, all patients ultimately develop hormone-refractory prostate cancer (HRPC).     Management of HRPC patients is a significant challenge for both patient and physician.     Neither past nor current chemotherapy regimens have shown curative potential in patients with     HRPC. Thus new treatment strategies are a high priority.      A major focus of new treatment strategies is to enlist the aid of the immune system,     particularly the development of prostate cancer vaccines. There has been a number of studies     using dendritic cell based vaccines and the treatment has been well tolerated. Specific     T-cell immune responses have been observed and occasional evidence for tumor regression. A     reduction in serum prostate-specific antigen (PSA) has been observed as well. Lengthening the     time-to-progression and delays in the onset of bone pain have been observed in subsets of     patients with HRPC.      The initial preclinical observations suggesting that a granulocyte-macrophage     colony-stimulating factor (GM-CSF) gene transduced allogeneic (GVAX) prostate cancer vaccine     may be efficacious in poorly immunogenic cancers were reported.      The objective of this study is to evaluate the safety and immunologic effects of vaccinations     with Allogeneic Prostate GVAX® (CG1940 & CG8711) in patients made lymphopenic by treatment     with chemotherapy and infused with autologous peripheral blood mononuclear cells (PBMC).     Clinical observations and laboratory measurements will be monitored to evaluate safety,     toxicity and immune responses. Additionally, the effects of treatment on serum PSA levels and     tumor response will be evaluated.   "
174276|NCT00122213|"     Advancing age in itself is associated with changes in body composition. However, during     transitional life stages, such as retirement, detrimental changes on diet and physical     activity may occur. This might lead to weight gain and accumulation of abdominal fat.      To prevent these changes, participants receive a low-intensity intervention on energy balance     and related behaviours.      After six months, one and two years, the effects will be studied by comparing the     intervention group with the control group.   "
174262|NCT00122018|"     Patients with abnormal kidney function are at increased risk for complications following     heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged     stay in the critical care unit and hospital, and the increased risk of death. Prior attempts     at kidney protection for heart surgery patients have had mixed results. Two medicines,     fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other     circumstances that cause kidney stress. The purpose of this study is to determine whether     these medications will help to maintain the function of diseased kidneys during heart     surgery.   "
174263|NCT00122031|"     This study will investigate the use of deep brain stimulation (DBS) to reduce symptom     severity and enhance the quality of life for patients with treatment-refractory major     depression.   "
174264|NCT00122044|"     This study is an open-label trial of trihexyphenidyl in children with upper extremity     dystonia due to cerebral palsy. It is hypothesized that trihexyphenidyl in doses up to     0.75mg/kg/day would be well-tolerated and show significant changes on the Melbourne scale of     upper extremity function.   "
174265|NCT00122057|"     The aim of this study is to determine whether antibiotic treatment could reduce mechanical     ventilation duration in patients with nosocomial tracheobronchitis acquired under mechanical     ventilation.   "
174266|NCT00122070|"     Objective:      The objective of this study is to quantitatively examine the efficacy of Seroquel (active     ingredient quetiapine fumarate) in subjects with Borderline Personality Disorder (BPD). A     secondary objective is to characterize the safety and tolerability of utilizing quetiapine in     patients with Borderline Personality Disorder.      Design:      Investigator initiated, 6-week, non-placebo controlled, non-randomized, open-label, single     drug, single-center, medication trial.      Participants:      Volunteers (n = 15) diagnosed with Borderline Personality Disorder using the Structured     Clinical Interview for DSM-IV Personality Disorders (SCID-II).      Interventions:      Subjects with Borderline Personality Disorder are washed out of all other medications. The     subjects are then given the study drug at a dose within the drug's known therapeutic range.   "
174267|NCT00122083|"     The purpose of this study is to determine the effectiveness of a simple marketing     intervention in changing attitudes towards depression and its treatment among university     students.   "
174268|NCT00122096|"     Surgery initiates a complex cascade of events involving the release of chemical compounds     from nerve endings and damaged tissue which leads to an inflammatory and pain response. The     purpose of this investigation is to measure various chemical mediators in the blood and     cerebrospinal fluid, and to test the hypothesis that they will be decreased in patients     treated with a COX-2 inhibitor.   "
174269|NCT00122109|"     Telemedicine has the potential to profoundly influence the delivery of specialized care to     the remote veteran population suffering with PTSD. Preliminary research supports telemedicine     technology as a possible solution to improve access to mental health services for veterans     with PTSD. The proposed research is a treatment-outcome study that will assess the clinical     efficacy of conducting an Anger Management Therapy (AMT) group treatment intervention using a     videoteleconferencing (VTC) modality as compared to the traditional in-person modality with     veterans who have PTSD and reside in remote locations on the Hawaiian Islands. AMT is a     manual-guided cognitive-behavioral, skill based group intervention that has been used     nationwide in VA substance abuse programs and most recently has been adopted by many VA PTSD     Clinical Teams to treat anger-related to the sequelae of PTSD.   "
174270|NCT00122122|"     Complications resulting from medications, or adverse drug events (ADEs), are prevalent and     are a major source of excess morbidity and costs. ADEs are particularly problematic in older     patients because of their higher burden of comorbidity and diminished physiologic reserve. In     addition, older patients are more likely to be exposed to polypharmacy, a major risk factor     for ADEs. While ADEs may be idiosyncratic, many result from medical errors and inadequate     systems for ensuring the safe and effective use of medications.      The goal of the proposed study is to test the efficacy of a potentially potent intervention     to improve the use of medications in older outpatients enrolled in VA primary care clinics.     The intervention-Enhanced Pharmacy Care-involves a formal, multi-dimensional evaluation of     patients� medication regimens by a trained clinical pharmacist and board-certified     geriatrician.   "
174271|NCT00122135|"     The goal of this research agenda is to improve the quality of end-of-life care by explicitly     identifying values that will guide the decision-making process, with a particular emphasis on     the role of ethnic, racial and cultural factors.   "
174343|NCT00123097|"     The purpose of this study is to evaluate a new rubber material used to make prosthetic     replacements of the face lost to cancer, trauma, or birth defects.   "
174272|NCT00122148|"     This is a pilot study to first measure the cross-sectional relationship between variations in     physicians� vignette scores and aggregated scores of individual physicians� patient health     outcomes; and second to (longitudinally) determine whether feedback of vignette scores     improves physicians� clinical performance as measured by vignettes   "
174273|NCT00122161|"     Clinical trial of implementation of clinical practice guidelines for managing hypertension in     primary care clinics.   "
174274|NCT00122174|"     Although family caregivers perform an incredibly valuable service for their relatives and the     formal health care system, they do so at a considerable cost to themselves both emotionally     and physically. Effective stress management techniques can: 1) help to decrease the     caregivers' feelings of burden and stress; 2) improve the emotional and physical health of     caregivers; and 3) empower caregivers to gain control of their lives.   "
174275|NCT00122187|"     Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United     States. Results from randomized clinical trials and intervention studies have suggested that     implementation of a CRC screening program for men and women over age 50 results in reduced     CRC mortality. However, for this reduction to be fully realized, it is imperative that all     positive screening tests are followed by complete diagnostic evaluation (CDE). Numerous     intervention programs have been used to improve initial CRC screening rates, but data     indicate that outside the research setting, less than half of patients with a positive fecal     occult blood test (FOBT) screening result undergo CDE. To enhance the translation of this     best practice recommendation to clinical practice, the investigators propose to implement an     electronic event notification intervention (CRC-ENS) directed at making physician and system     level changes to increase the proportion of patients with an abnormal FOBT that undergo CDE.   "
174278|NCT00122239|"     This study will examine, for the first time, the independent contribution of a patient's own     genetic makeup to the development of post-radiation complications, permitting the future     development of predictive tests to avoid radiation injury. To do this, the investigators will     examine gene markers in a series of breast, prostate, brain and lung cancer survivors who     have received conformal radiotherapy between 1996 and 2003 at the Cross Cancer Institute and     Tom Baker Cancer Centre.   "
174279|NCT00122252|"     The clinical outcome after external beam irradiation for prostate cancer is disappointing in     the advanced tumor stages. There are indications that an increase in radiation dose to the     tumor will improve outcome significantly, especially to the biologically active tumour parts     within the cancer area. Until recently no imaging equipment was available to define both the     anatomic and biologically active tumor parts. Now, at the Center for Biological Imaging and     Adaptive Radiotherapy, equipment is at hand that will be able to visualise the areas     mentioned above. When combining the data of these imaging modalities it might be possible to     create an optimised irradiation plan. This study is a planning study in which, on 15     patients, the different anatomical and biological imaging data per patient will be evaluated,     matched and finally a theoretical improved irradiation treatment plan will be made. This     research complies with the current opinion on radiation development. Progress in functional     imaging is likely to provide the tools required for individualised risk-adapted radiotherapy.   "
174280|NCT00122265|"     Prostate cancer is the most common malignancy in males, and radiotherapy is a commonly chosen     treatment option for patients with localized disease. Technical innovations such as     three-dimensional conformal radiotherapy (3D CRT) and intensity-modulated radiotherapy permit     radiation dose escalation and possibly better disease outcomes, but escalated doses may be     accompanied by long-term complications. This study will examine, for the first time, the     independent contribution of a patient's own genetic makeup to the development of     post-radiation complications, permitting the future development of predictive tests to avoid     radiation injury. To do this, the investigators will examine gene markers and blood proteins     in a series of approximately 100 prostate cancer survivors who have received     three-dimensional conformal radiotherapy between 1996 and 2000 at the Cross Cancer Institute.   "
174281|NCT00122278|"     Migraines are a specific type of headache that frequently recur and are very painful.     Although there are many medications that are effective against migraines, none of these     medications cure 100% of migraines. Another problem with migraines is that although many     times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3     of the time migraines recur the next day. The purpose of this research project is to see if     adding a medication called dexamethasone to standard ER therapy will help patients get better     quicker and stay pain-free more often than if they receive placebo.   "
174282|NCT00122291|"     The purpose of this trial is to study the efficacy of preoperative radiation therapy and     capecitabine in locally advanced rectal cancer.   "
174283|NCT00122304|"     The primary objective is to evaluate the safety of eculizumab in patients with     transfusion-dependent hemolytic PNH   "
174284|NCT00122317|"     The purpose of this study is to evaluate the long-term safety of eculizumab in patients with     transfusion dependent hemolytic PNH.   "
174285|NCT00122330|"     The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion     dependent patients with hemolytic PNH.   "
174286|NCT00122343|"     This is an open-label nonrandomized multi-center study designed to evaluate the effect of     AP23573 in patients with recurrent or persistent endometrial cancer. The primary objective is     to assess the efficacy of AP23573 in patients with recurrent or persistent endometrial cancer     when administered once daily for 5 consecutive days (QDx5) every two weeks at a dose of 12.5     mg/day.   "
174287|NCT00122356|"     The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in     preventing bone loss in postmenopausal women with early breast cancer who are receiving     anastrozole therapy, and to determine how long alendronate treatment is needed.   "
174288|NCT00122369|"     Percutaneous large core image-guided breast biopsy is a well established tool in diagnosing     breast cancer, but the associated anxiety and pain can tax the coping mechanism of even well     functioning individuals. Unabated stress during an invasive procedure not only interferes     with smooth progression of the ongoing procedure, but can also have deleterious effects when     patients need additional procedures and dread recurrent medical traumatization. The long-term     objective of this research is to provide patients with a simple coping strategy at the     vulnerable time of large core biopsy in the hope that this behavioral intervention will carry     over to recovery and future medical procedures. In the largest prospective randomized study     of its kind, the researchers showed that a self-hypnotic intervention during percutaneous,     image-guided vascular and renal interventions resulted in less pain and anxiety, greater     hemodynamic stability, and fewer procedure interruptions. The positive effects of the short     initial hypnotic intervention, which was structured in the procedure room, became more     pronounced the longer the procedure lasted and carried over into the immediate post-procedure     recovery. The investigators therefore challenge the current paradigms that long-lasting     effects require intensive presurgical preparation.   "
174289|NCT00122382|"     This is a world wide study to evaluate the remission and joint damage in subjects treated     with abatacept in addition to methotrexate versus subjects who receive methotrexate along     with a placebo.   "
174290|NCT00122395|"     The purpose of this study is to compare the safety, acceptability and ease of the     administration of two screening methods, a pen and paper questionnaire and an audiotape with     headsets, for screening for intimate partner violence in a pediatric emergency department     (ED).   "
174291|NCT00122408|"     The objective of this study is to assess the effects of a daily enteral supplementation with     probiotics within a population of critically ill, mechanically ventilated patients.     Especially, the effects of probiotics on mortality rate in intensive care medicine will be     analysed.   "
174292|NCT00122421|"     The goal of this study is to investigate a comprehensive provider-focused intervention to     improve the quality of care for diabetic patients in a large primary care practice at Brigham     and Women's Hospital. This will be accomplished through pharmacist recommendations provided     to primary care providers prior to routine scheduled office visits for diabetic patients.   "
174294|NCT00122447|"     The purpose of this study is to determine whether cardiovascular disease (CVD) risk markers,     β-cell function, and insulin sensitivity can be improved by targeting mechanisms of both     diabetes and CVD - using an antioxidant, an angiotensin II receptor blocker (ARB), or an     anti-inflammatory agent - in patients with impaired glucose tolerance (IGT) in a randomized,     controlled trial.   "
174295|NCT00122460|"     The purpose of this trial is to investigate the efficacy of cetuximab in combination with     chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic     head and neck cancer. Overall survival will be taken as the primary measure of efficacy.   "
174296|NCT00122473|"     The purpose of this study is to determine whether imatinib is effective in the treatment of     primary and recurrent dermatofibrosarcoma protuberans (DFSP).   "
174297|NCT00122486|"     This Phase 2 study involving tenofovir disoproxil fumarate (TDF) will assess the extended     safety of TDF 300 mg per day among young women who are not HIV-infected.   "
174298|NCT00122499|"     This study has been designed to evaluate the efficacy and safety of a 20-mg dose of tadalafil     administered “on demand” to patients with erectile dysfunction (ED) after external-beam     radiotherapy (EBRT) of prostate cancer.   "
174299|NCT00122512|"     This Phase 2a study involving Tenofovir Disoproxil Fumarate (TDF) will provide extended     safety data for high-risk men. Secondarily, the study will assess the feasibility of     conducting the trial and evaluate the preliminary effectiveness of TDF 300 mg as an HIV     prevention method when taken once a day.   "
174300|NCT00122525|"     Observational studies suggest that male circumcision may provide protection against HIV-1     infection. A randomized, controlled, intervention trial was conducted in a general population     of South Africa to test this hypothesis.   "
174301|NCT00122538|"     The purpose of this study is to try a known antiretroviral combination in HIV- infected     children with only one intake a day, in order to simplify the prescription and improve     adherence to treatment. This is what is called a phase II clinical trial, only recruiting and     following a small number of children (50) during one year to evaluate the quantity of drug in     the blood just before it is taken and one to three hours after it is taken. The other     important objective is to study the tolerance of drugs in that mode of prescription of the     triple combination.   "
174302|NCT00122551|"     Although lifelong continuous therapy with HAART remains the standard of care of HIV     infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and     provide substantial decline in HIV-related morbidity and mortality, long-term toxicity     associated with antiretroviral therapy is a real concern. The purpose of this study is to     compare an intermittent therapy strategy to a continuous treatment in patients with chronic     and well controlled HIV-1 infection.   "
174303|NCT00122564|"     It is probable that a mucosal approach is necessary for a prophylactic HIV vaccine protecting     against sexually transmitted infection. Mucosal immune responses have been almost     non-existent in trials of HIV vaccine candidates in which the antigen was delivered     systemically. This study will test the safety and immune response of a recombinant HIV-1gp160     by nasal and mucosal routes alone or formulated with DC-Chol in healthy volunteers.   "
174304|NCT00122577|"     This trial is aimed at studying the antiviral activity, toxicity and pharmacokinetic (PK)     interactions of tenofovir DF and atazanavir enhanced with low dose of ritonavir given alone     and then concomitantly as part of a salvage regimen to HIV patients with multiple failure,     under conditions allowing to tease out the specific role of atazanavir combined with low dose     of ritonavir.   "
174305|NCT00122590|"     This Cophar2 study is a trial which evaluates repeated early therapeutic drug monitoring,     from weeks 2 to 24, after the initiation of HAART including either indinavir/r, lopinavir/r     or the new 625 mg formulation of nelfinavir twice-a-day (bid). If trough concentrations were     out of the range given for each protease inhibitor (PI), the PI dose was adjusted.   "
174306|NCT00122603|"     The purpose of this study is to evaluate virological efficacy and safety of two double     protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg     twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease     inhibitor naive HIV-1 patients.   "
174307|NCT00122616|"     The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with     liver disease caused by hepatitis C virus (HCV) when the treatment to eradicate the virus     failed. This scientific proof needs a comparative study to be done including two groups of     patients randomly allocated: one with the treatment (peginterferon) and the other without any     treatment against HCV with a duration of 2 years. To conclude, two liver biopsies are needed;     one before the study and a second 2 years after.   "
174308|NCT00122629|"     Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to     increase sustained virological response (SVR) rates in HCV non-responders to a standard     interferon/ribavirin combination.      Patients with hepatitis C virus infection were eligible if they had failed to respond to a     single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was     defined as persistent HCV RNA in the serum during the last month of treatment.      This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and     amantadine or a placebo for 48 weeks.   "
174327|NCT00122876|"     The purpose of this study is to determine whether the Litx™ treatment is safe and effective     in treating inoperable hepatocellular carcinoma (HCC).      Litx™ is an integrated treatment system comprising an intravenously administered     photosensitizing agent, Talaporfin Sodium (LS11), that is activated by non-coherent light     generated inside the tumor by an implanted light emitting diode (LED) array light source.   "
174328|NCT00122889|"     This study will determine whether garlic supplements affect the way certain drugs are     processed in the body.   "
174329|NCT00122902|"     This study is assessing the extent of spirituality in patients with HIV/AIDS and will     determine the relationship between spirituality, health status, and the will to live.   "
174330|NCT00122915|"     The CONCEPT study has been designed to evaluate the safety and the efficacy of Motor Cortex     Stimulation (MCS) with a new cortical lead (circular lead, eight electrodes, Medtronic Inc,     Minneapolis, USA) in the treatment of intractable neuropathic pain, in particular for central     post-stroke pain (CPSP) and trigeminal neuropathic pain (TGN)/facial pain.   "
174309|NCT00122642|"     In modern-day medicine, the use of central venous catheters has become unavoidable. However,     their use does not come without risk. It puts patients in danger of infectious complications     (catheter-related infections [CRI]), the most important of which is catheter-related     bloodstream infection (CRBSI). CRBSI is associated with a significant increase in hospital     stay and, therefore, cost of patient management, morbidity, and probably also mortality.     There still is an urgent need for effective, cheap and easy to implement measures to prevent     CRI that are without risk of developing antibiotic resistance.      During use, bacteria can colonize the inner surface of the catheter. This endoluminal route     of infection can be prevented to some extent when an antibiotic solution is instilled in the     catheter for a long enough time and on a regular basis. However, to avoid resistance from     occurring, the use of antibiotics for infection prevention should remain exceptional.      The use of a non-toxic antiseptic might be a better alternative. Recently, the use of an     alcohol lock solution was suggested as a promising way to prevent CRBSI and the compatibility     of polyurethane and silicone catheters submerged in an alcohol solution was publicized with     no biomechanical or structural changes detected after 9 weeks of immersion. The major     advantage of an alcohol lock solution would be the broad antimicrobial spectrum without the     risk of compromising future antibiotic treatment as, in contrast to the use of an antibiotic     lock, the development of antibiotic resistance is not of concern. Furthermore it would be     cheap and universally available.      In this randomised study, the efficacy of a 70% alcohol lock solution for the prevention of     CRBSI will be compared with placebo when applied for 15 minutes per day.   "
174310|NCT00122655|"     The aim of this trial is to evaluate the impact on fat distribution of switching to     NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral     suppression.      Maintenance of virological suppression and immunological factors are also assessed.   "
174311|NCT00122668|"     The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1     infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor     (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor     (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI     plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed     tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).   "
174312|NCT00122681|"     Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and     genitals in men and women. Several types of HPV infection are transmitted by sexual activity     and, in women, can infect the cervix (part of the uterus or womb). This infection often goes     away by itself, but if it does not go away (this is called persistent infection), it can lead     in women over a long period of time to cancer of the cervix. If a woman is not infected by     HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the     efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated     cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in     young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study     subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine)     administered intramuscularly according to a 0-1-6 month schedule.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
174313|NCT00122694|"     The purpose of this study is to determine whether carbon monoxide is effective in the     treatment of stable COPD.   "
174314|NCT00122707|"     The purpose of this study is to compare the mechanical and infectious complications of     peripheral versus central venous catheters in critically ill patients. Group allocation will     be performed by randomization.   "
174315|NCT00122720|"     The study is investigating whether randomization to perioperative darbepoetin alfa treatment     improves the rehabilitation following surgery for colonic and rectal cancer.   "
174316|NCT00122733|"     Patients may be very agitated during the weaning period from mechanical ventilation.     Administration of loxapine, a neuroleptic that does not notably affect ventilatory drive, may     help in obtaining an adequate level of cooperation and, therefore, in reducing the duration     of mechanical ventilation.   "
174317|NCT00122746|"     The researchers plan:        -  To undertake clinical studies of radiotherapy with or without the administration of the          chemotherapeutic agent cisplatin, known to be a radiosensitizer;        -  To perform pre-clinical studies of the radiosensitivity of human fibroblasts and          cervical cancer cell lines in culture, with or without the addition of various HIV          proteins or protease inhibitors, in order to determine the extent of any cellular          radiosensitizing properties of these molecules;        -  To develop strategies for sensitizing tumour cells to radiation, specifically by          down-regulating specific viral proteins that are known to be factors associated with          resistance to radiotherapy.   "
174344|NCT00123110|"     The purpose of this research study is to determine if a relationship between insulin     resistance (IR) and testosterone (T) exists in women who have already gone through menopause.   "
174318|NCT00122759|"     -  Adequate sedation is of paramount importance to avoid stress and pain in mechanically          ventilated patients. It is usually achieved by infusing sedatives (benzodiazepine) and          analgesic (opiate) drugs.        -  This combined sedation may not be sufficient in some instances.        -  The aim of this study is to evaluate whether addition of a third substance, ketamine,          allows the achievement of better sedation and avoids the use of neuromuscular blocking          agents.   "
174319|NCT00122772|"     The purpose of this trial is to study clinical effects of two/four high dose rate (HDR)     brachytherapy applications and teletherapy with or without weekly cisplatin in cervix cancer.   "
174320|NCT00122785|"     The purpose of this study was to determine whether a single intramuscular injection of     dexamethasone decreased the duration of symptoms of acute bronchiolitis in young children.   "
174321|NCT00122798|"     The investigators implemented a structured chain of acute stroke care with early integrated     rehabilitation. The mortality at 6 months was lower (12%) compared to 23% in the     International Stroke Trial (IST) and 39% (67%) of the patients were dead or dependent, which     is superior compared to international data.   "
174322|NCT00122811|"     The purpose of this study is to assess the benefits and risks of treating very elderly (those     aged 80 or older) individuals with hypertension.   "
174323|NCT00122824|"     This is a clinical trial assessing duloxetine compared with placebo in patients who have     generalized anxiety disorder.   "
174332|NCT00122941|"     Micronutrient deficiencies are common in HIV infected children and are aggravated by poor     nutrition, especially in poor resource countries such as Uganda. It appears that     micronutrient deficiencies contribute to immune dysfunction, increased morbidity and HIV     disease progression. Hitherto, there has been no randomised controlled trial to assess the     effect of multiple micronutrient supplementation on morbidity and mortality in HIV infected     children in Africa. Therefore, the investigators shall carry out a randomised controlled     trial to determine the effect of multiple micronutrient supplementation on morbidity, weight     gain and mortality among HIV infected children aged 1 to 5 years in Uganda.      Hypothesis: Daily administration of twice the recommended dietary allowance (2RDA) of     multiple micronutrients to HIV infected children aged one to five years, for 6 months, will     reduce all cause mortality from 24% to 14.4% in one year and result in a weight gain     difference of 150 grams.   "
174333|NCT00122954|"     This study will determine whether fish oil can reduce depression in people with multiple     sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant     medication.      Study hypothesis: Three months of fish oil supplementation will improve depression scores on     the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI)     better than placebo.   "
174334|NCT00122980|"     The purpose of this study is to compare standard therapy (transfusions and chelation) with     alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and     management of iron overload in children with sickle cell anemia (SCA).   "
174335|NCT00122993|"     The purpose of this study is to implement and evaluate a two-year multi-component     environmental intervention to prevent weight gain among city bus drivers at four bus garages.      It is hypothesized that transit employees in the intervention garages will gain less weight     compared to the transit employees in the control garages.   "
174336|NCT00123006|"     The purpose of this study is to test the effects of the DASH diet in patients with isolated     systolic hypertension.   "
174337|NCT00123019|"     The purpose of this study is to increase physical activity, improve diet, and reduce obesity     of hotel employees.   "
174338|NCT00123032|"     The purpose of this study is to prevent excessive weight gain among kindergarten and first     grade American Indian children using improved diet and increased physical activity at home     and at school.   "
174339|NCT00123045|"     To test the efficacy of a patient-centered, culturally tailored education and activation     intervention designed to improve adherence to medication and life style recommendations among     adults with uncontrolled hypertension.   "
174340|NCT00123058|"     The purpose of this study is to improve adherence to blood pressure (BP) monitoring and     medication compliance in individuals with high BP.   "
174341|NCT00123071|"     This observational study will provide data (variations in ventricular size and function) that     are essential to designing and conducting clinical trials. In addition, the study will     evaluate intra- and inter-study variability seen in echocardiography.   "
182273|NCT00229411|"     The purpose of the study is to check whether training mixed teams of physicians and nurses     from intensive care units on patient simulators improves teamwork within the teams.   "
174345|NCT00123123|"     Recent studies have found that poor oral hygiene may foster the colonization of the     oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care     unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent     ventilator-associated pneumonia (VAP).      The specific aims of this investigation are: 1) to organize the necessary infrastructure to     develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to     prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if     the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque,     oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.   "
174346|NCT00123136|"     The researchers will study the application of a commercial pulsed magnetic stimulating device     to the feet of patients with moderate-severe foot pain secondary to diabetic peripheral     neuropathy (DPN).   "
174347|NCT00123149|"     The purpose of this study is to evaluate the long-term safety profile of epoetin alfa in     patients with anemia of chronic disease due to rheumatoid arthritis   "
174348|NCT00123162|"     The primary hypothesis is that a 100mg single dose of sildenafil citrate (Viagra) will have a     higher improvement rate when compared to placebo in the treatment of moderate to severe     primary dysmenorrhea.   "
174349|NCT00123175|"     The purpose of this research is to determine the effectiveness of the intrauterine device     (IUD) called Mirena when compared to the Provera tablets used in treating this condition.   "
174350|NCT00123188|"     The investigators hypothesize that endometrial thickness will be a significant predictor of     endometrial hyperplasia in a postmenopausal female population with metabolic syndrome:     diabetes and/or insulin resistance, hypertension, and obesity.   "
174351|NCT00123201|"     The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI     for the acute treatment of moderate to severe migraine headache.   "
174352|NCT00123214|"     The purpose of this study is to determine whether or not a low calorie, low glycemic index     diet with omega-3 fatty acid supplements can prevent some of the negative consequences of     sleep deprivation.   "
174353|NCT00123227|"     The purpose of this study is to determine whether rosiglitazone, a peroxisome proliferator     activated receptor gamma (PPAR-gamma) agonist, induces regression in carotid atherosclerotic     plaques in diabetic patients with vascular disease and/or hypertension over a 12 month     period.   "
174354|NCT00123240|"     The purpose of this study is to compare the ability of low calorie high carbohydrate and low     calorie high fat/protein diets to decrease abdominal fat in overweight and obese subjects.     The investigators will also test the effects of these diets on secondary outcomes including     body composition, fluid and electrolyte balance, lipids and lipoproteins, blood pressure,     arterial compliance, glucose and insulin metabolism, bone turnover, and measures of satiety.   "
174406|NCT00123929|"     After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer     are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100     mg/m2 e3w). After the fourth cycle, patients are submitted to surgery to ascertain     pathological response. They then receive the opposite drug, hormones, Herceptin, and     radiation as indicated.   "
174355|NCT00123253|"     HIV lipodystrophy affects a significant proportion of patients treated with combination     antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and     loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin     resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily     administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with     an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral     adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous     adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2     mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess     of abdominal fat accumulation.   "
174356|NCT00123266|"     The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to     open blocked arteries to the brain in patients with acute stroke when given into the artery     at the site of the blockage.   "
174357|NCT00123279|"     The purpose of this trial is to evaluate the safety and preliminary efficacy of different     doses and several exposure times of intravitreal microplasmin in the setting of pars plana     vitrectomy for vitreomacular traction maculopathy.   "
174358|NCT00123292|"     The purpose of the trial is to evaluate the safety and efficacy of microplasmin     administration in patients with acute peripheral arterial occlusion.   "
174359|NCT00123305|"     The primary purpose of this study is to evaluate the safety and preliminary efficacy of     microplasmin when administered intravenously to patients who have suffered an acute stroke     within 12 hours before randomization.   "
174360|NCT00123318|"     The purpose of this study is to determine the side-effects and effectiveness of a new type of     chemoradiotherapy treatment for patients who have had surgery for stomach cancer. The     treatment uses epirubicin, cisplatin, and 5-fluorouracil (ECF) chemotherapy together with     radiotherapy.   "
174361|NCT00123331|"     Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine     medication was addressed. Current therapeutic approaches include cyclosporine reduction or     discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a     beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity?      Study Design: Heart transplant patients with a moderate degree of renal failure on low dose     cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine     and initiation of rapamycin immunosuppression.      Read-Out: Renal function after 6 months; tolerability; and safety were assessed.   "
174362|NCT00123344|"     Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with     substantial morbidity and mortality. Present treatment strategies are aimed at termination of     AF and prevention of AF recurrence using antiarrhythmic drugs or heart rate control drugs.     Drugs are not always well tolerated, so atrial pacing as a strategy for prevention of atrial     tachyarrhythmias is being explored.      The AT501 pacemaker has both prevention and treatment algorithms for atrial     tachyarrhythmias. The investigators wish to determine whether these special features, over     the long term, decrease the amount of time the person experiences AF.   "
174422|NCT00117260|"     This is a randomized, multicenter, placebo-controlled study to evaluate the effects of     Seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent     females who have had their menstrual period but now have secondary amenorrhea and also have     osteopenia. The duration of the study for each patient will be approximately two years.   "
174363|NCT00123357|"     Approximately 11,000 veterans annually are hospitalized with a newly acquired incident     stroke. Based on American Heart Association ratios of stroke incidence and prevalence, up to     80,000 veterans may be stroke survivors. The assessment of outcomes in stroke survivors is     important for clinical practice and research, yet there is no consensus on the best measures     of stroke outcome in either clinical practice or research. We have developed a new     stroke-specific outcome measure, the Stroke Impact Scale (SIS), to capture physical function     and other dimensions of health-related quality of life.   "
174364|NCT00123370|"     The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks     plus a tailored cognitive behavioural therapy program in the treatment of methamphetamine     dependence.   "
174365|NCT00123383|"     The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks     plus a tailored cognitive behavioural therapy program in the treatment of cocaine dependence.   "
174366|NCT00123396|"     Our 4-year project uses public domain software and content developed by a University of     Alabama at Birmingham (UAB) team and updates, refines, and tailors it to the unique clinician     populations and electronic educational applications of VAMCs We are testing an innovative,     web-based intervention adapted specifically for the VA to increase syndromic recognition,     treatment, and post-exposure prophylaxis of biological warfare agents at multiple VA sites     via a randomized controlled trial (RCT). Ultimately, we will disseminate the intervention     throughout the entire VA system.   "
174367|NCT00123409|"     The aim of this study is to test for improvements in treatment outcomes for primary care     patients with at-risk drinking when cared for using telephone disease management (TDM)     compared to those treated with usual care. Based on our pilot data, TDM for at-risk drinking     may be a viable method for reducing alcohol consumption in this population.      Hypotheses: The hypotheses for this research plan are: 1. A significantly greater proportion     of patients assigned to TDM will obtain improvement in drinking outcomes compared to usual     care. 2. TDM will lead to greater access to behavioral health care and higher intensity of     treatment relative to usual care. This effect will be moderated by logistics such as     transportation problems, physical functioning, and employment status. 3. More patients     assigned to TDM will receive guideline adherent care.   "
174368|NCT00123422|"     The purpose of this study was to compare the effect of exercise treatment combined with     breathing retraining (a computerized feedback program), with exercise treatment combined with     heliox (a helium and oxygen combination), with exercise only in patients with moderate to     severe chronic obstructive pulmonary disease. This was an 8-week intervention study.   "
174369|NCT00123435|"     The objective of this study is to determine whether a tailored web-based system for providing     feedback on walking step-counts, in combination with regular nutrition counseling, can     improve weight loss over nutrition counseling alone in patients with heart disease.   "
174370|NCT00123448|"     This study will determine if the type of gesture, increased quantity of an image, and the     number of times a face is shown repeating a gesture bring about activation in the mirror     neurons. Researchers aim to learn about which areas of the brain are necessary to perform     certain cognitive tasks-that is, relating to a person's thinking or remembering-especially     visual and motor tasks. Because one way humans learn is by imitation, a mechanism is required     to transfer the behavior the person adopts from others through observation. This type of     learning could be based on a mechanism similar to that provided by mirror neurons. From     previous studies it has been learned that the observation of hands and mouths has brought     about the most effective ways of activating the mirror neurons.      Patients ages 21 to 55 who are in good health, are right handed, are not pregnant, and are     native speakers of English may be eligible for this study. There will be about 24     participants.      Patients will undergo a magnetic resonance imaging (MRI) scan. Before the scan, they will     complete a safety questionnaire about the presence of any metal in their bodies. Patients are     at risk for injury from the MRI magnet if they have pacemakers, dental implants or other     devices. Female patients will undergo a pregnancy test. The technique MRI uses includes a     strong magnetic field and radio waves to obtain images of body organs and tissues. During the     initial MRI scan, patients will lie still on a table that will slide into the enclosed tunnel     of the scanner. They will be in the scanner for about an hour. During the procedure, they may     be asked to lie as still as possible for up to 20 minutes at a time. As the scanner takes     pictures, patients will hear knocking or beeping sounds. Each participant will wear earplugs     to reduce this noise. They will be able to communicate with the MRI staff at all times during     the scan, and they may ask to be removed from the machine at any time. The functional MRI     (fMRI) scan will involve taking pictures of the brain while patients are performing tasks.     All the tasks will be explained, and patients will have the chance to practice them before     entering the scanner. During the fMRI, patients will view short film segments of people     making gestures. Before and after the scan, patients will be asked to complete several short     questionnaires. The testing sessions will take a total of about 2 hours.      Participants will receive compensation for their time and inconvenience, with a maximum     payment of $200. This study will not have a direct benefit for participants.   "
174371|NCT00123461|"     The purpose of this study is to demonstrate the safety and effectiveness of Hectorol®     (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney     disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal     range. Previous studies with doxercalciferol were conducted in patients who had low levels of     vitamin D.   "
174372|NCT00123474|"     This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia     chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant     to imatinib mesylate (Gleevec).   "
174373|NCT00123487|"     This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in     accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome     positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib     mesylate (Gleevec).   "
174374|NCT00123500|"     The goal of the project is to develop, implement, and evaluate, through a randomized     controlled trial at a worksite, an intervention to promote increased physical activity     behavior and healthier eating behavior to reduce overweight and obesity among elementary     school personnel.   "
174375|NCT00123513|"     The purpose of this study is to design a comprehensive nutrition and physical activity     strategy to gain a broad understanding of the social and cultural role of food and physical     activity among workers. Perspectives on innovative interventions that are socially feasible     and culturally acceptable will also be obtained. Health lifestyle promotion interventions     addressing portion control, healthy nutrition, and increasing physical activity will be     tested.   "
174376|NCT00123526|"     This study will evaluate the effectiveness of an environmental worksite intervention to     reduce obesity among hospital employees.   "
174377|NCT00123539|"     The purpose of this study is to test whether perioperative estrogen replacement in     postmenopausal women reduces the risk for neurologic injury after coronary artery bypass     graft (CABG) surgery.   "
174378|NCT00123552|"     The purpose of this study is to compare different ways of treating uncomplicated malaria in a     group of Ugandan children. The study will be divided into 2 parts. Part 1 of the study will     consist of 600 children, ages 1-10, living in the Mulago III Parish of Kampala. Approximately     90 children living in the same household as children from the Phase 1 portion of the study     will be enrolled in Phase II of this study. Participants in Phase II of the study will     receive an insecticide treated net to cover their bed. Over the course of the study,     participants will be tested for malaria when they present to the clinic with a fever or     illness. Participants that test positive for malaria will be given 1 of 3 possible study drug     combinations. Study procedures will include physical exams and blood samples. Children will     participate for about 3 years. Protocol 05-0110 is a study related to this protocol.   "
174379|NCT00123565|"     The purpose of this study is to test whether SR123781A is a possible treatment for patients     with acute coronary syndromes (heart attack) who are scheduled to undergo a percutaneous     coronary intervention (PCI) within 48 hours after inclusion in the study. Two doses of     SR123781A are currently tested, each in a group of about 180 patients per group to find which     is the most adequate, versus heparin and glycoprotein IIbIIIa (GPIIBIIIA) antagonist.   "
174380|NCT00123578|"     Gamma hydroxybutyrate (GHB) is a powerful central nervous system depressant. The number of     individuals seeking treatment for GHB abuse has been steadily increasing in the United     States. Currently, lorazepam and pentobarbital are two medications used to treat individuals     who experience GHB-withdrawal symptoms. The purpose of this study is to describe the signs     and symptoms of GHB withdrawal and to identify predictors of withdrawal severity. The study     will also evaluate the safety and effectiveness of treatment with lorazepam versus     pentobarbital for GHB detoxification.   "
174381|NCT00123591|"     This trial is conducted in Asia, Europe, Middle East, and North America. The primary     objective of the trial is to evaluate the safety of Recombinant Activated Factor VII in     patients with brain contusions. The secondary objective of the trial is to evaluate the     preliminary efficacy of Recombinant Activated Factor VII in preventing early haemorrhagic     progression in contusive brain injury.   "
174382|NCT00123604|"     The purpose of this study is to compare the vascular effects of two commonly used blood     pressure medications, carvedilol and metoprolol in hypertensive patients with type 2     diabetes.   "
174383|NCT00123617|"     The study is designed to test the hypothesis that participation in a standard phase III group     based cardiac rehabilitation programme will improve psychological morbidity, quality of life     and cardiovascular risk factors, along with chest pain severity and frequency in women with     cardiac syndrome X.   "
174407|NCT00123942|"     The primary objective of this study is to determine the maximum tolerated dose (MTD) and     safety and tolerability of MEDI-507 in patients with CD2-positive lymphoproliferative     disorders.   "
174408|NCT00123955|"     The purpose of this study is to examine whether spironolactone will improve exercise     tolerance and quality of life in elderly patients with heart failure preserved ejection     fraction (HFPEF).   "
174384|NCT00123630|"     Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by     dysphagia, food impaction or other obstructive esophageal symptoms in children and young     adults.      The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and     family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic     rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising     incidence of EE may be related to the worldwide allergy and asthma epidemic.      Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and     topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have     all been shown to be effective. However, none of these treatments are directed at the     specific pathophysiologic mechanism of EE and some have significant side effects.      The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies     directed at asthma may also be effective for EE. Specifically those targeted at the allergic     immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed     anti-IgE antibody that has been shown to decrease the use of inhaled and oral     corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related     symptoms in patients with allergic asthma. The objective of the study is to determine the     efficacy of omalizumab in the treatment of eosinophilic esophagitis   "
174385|NCT00123643|"     The purpose of this study is to compare the vascular effects of two commonly used diabetes     medications, rosiglitazone and glyburide in type 2 diabetic patients.   "
174386|NCT00123656|"     Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be     related to both allergies and acid reflux. There have been reports that both swallowed,     aerosolized steroids and proton pump inhibitors have been effective treatments. The     researchers propose to directly compare the efficacy of aerosolized fluticasone to     esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized     fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole     (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for     diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be     randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks,     subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires     (dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the     patient at the first endoscopy and at the end endoscopy. The primary objective is to measure     change in eosinophil infiltration of the esophagus in response to treatment of allergy     (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.   "
174387|NCT00123669|"     The purpose of this study is to test the effect of primary progesterone on overall and     disease free survival in women with operable breast cancer. The study addresses two issues     related to breast cancer surgery:        -  Circulating progesterone at the time of surgery might counteract the detrimental effect          of estrogen on survival of women with operable breast cancer.        -  Events at the time of surgery may have an impact on the natural history of breast cancer   "
174402|NCT00123877|"     The purpose of this early Phase II multicenter trial is to determine the objective clinical     response to GPX-100, an anthracycline similar to doxorubicin, in up to 40 patients with newly     diagnosed metastatic breast cancer. GPX-100 is unique among anthracyclines because it is not     converted to doxorubicinol during metabolism in the body. This metabolite has been shown to     be a major cause of damage to the heart (cardiotoxicity) in laboratory studies. Eligible     patients who are enrolled in this study will receive GPX-100 as a single agent at the     beginning of as many as 8 three week long cycles of chemotherapy. Objective measurements of     tumor response will be made by computed tomography (CT) scans.   "
174388|NCT00123682|"     TeleQuit is a group randomized trial testing whether a telephone care coordination program     increases the rate of smoking cessation treatment for VA patients at study sites. We are     testing whether proactive care coordination (counselor initiates the call to the patient) is     more effective than reactive coordination (coordinator waits for the patient to call); and     whether multi-session counseling is more effective than brief primary care-based counseling     plus self-help materials. We randomly assigned study sites to either quitline counseling or     brief counseling only. All patients receive brief smoking cessation counseling from their     primary care physician, smoking cessation medications (once they are in contact with the VA     care coordinator), and a follow-up call at 6 months. Care coordination will be provided by VA     clinical staff. Intensive counseling is provided by the California Smokers' Helpline.   "
174389|NCT00123695|"     There is increasing interest in myocardial abnormalities following central nervous system     events, such as subarachnoid hemorrhage (SAH). These cardiac abnormalities include ECG     changes, decreased cardiac output, decreased blood pressure, specific cardiac enzyme     elevations, and segmental wall motion abnormalities (SWMA). Interestingly, wall motion     abnormalities and ECG changes have shown to be reversible, and therefore the dysfunction has     been described as neurogenic myocardial stunning.      The pathophysiology of cardiac dysfunction following SAH has not yet been fully elucidated.     Many reports (mainly case reports) have been published, but so far no study has investigated     the frequency of these abnormalities in a prospective manner, have correlated the occurrence     of the different cardiac abnormalities, and have assessed which clinical variables can     predict cardiac dysfunction. And only a limited number of studies have related neurological     outcome with cardiac dysfunction.   "
174409|NCT00123968|"     The purpose of the study is to determine the safety of and immune response to an     investigational HIV vaccine, VRC-HIVDNA016-00-VP, and a vaccine booster, VRC-HIVADV014-00-VP,     in HIV uninfected adults from Kenya, Tanzania, and Uganda.   "
174410|NCT00117104|"     The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once     weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either     recombinant human erythropoietin (rHuEPO) naïve or subjects converted from rHuEPO therapy     administered IV thrice weekly (TIW).   "
174411|NCT00117117|"     The purpose of this trial is to prospectively assess the relationship between changes in     hemoglobin (hgb) and changes in symptom burden associated with anemia in cancer patients     receiving chemotherapy supported with Aranesp®.   "
174412|NCT00117130|"     The purpose of this study was to evaluate subject preference for Aranesp® administered once     monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).   "
174390|NCT00123708|"     This study will classify types of hypertonia in patients with cerebral palsy and determine if     the classifications are reasonable in relation to the functional task of walking. Hypertonia     is an abnormal increase in muscle tension. It is a common symptom of cerebral palsy that can     lead to loss of function and deformity. This study may help scientists improve evaluation     criteria for hypertonia and, ultimately, treatment results.      Patients with cerebral palsy who are older than 6 years of age may be eligible for this     study. Candidates are screened with a medical history and clinical evaluation.      Participants are asked to walk in the lab while cameras record their movement. During this     test, subjects wear a t-shirt and shorts with their arms and legs wrapped with a soft,     rubber-like material. A piece of firm material is attached to the rubber sleeves and small     plastic reflective balls are attached to the firm material. Balls may also be attached to the     skin, using an adhesive. With the balls in place, the subject walks several times while     cameras record the positions of the balls. In addition, small metal electrodes attached to     the skin with an adhesive measure the electrical activity in the muscles.      After the walking test is completed, subjects' leg muscle strength is measured with a special     device while they perform three activities. First, they sit on a special chair with their leg     and foot placed in an apparatus that measures their strength, then lie on their back, then on     their stomach, and then stand on one foot holding a bar to balance during part of one     activity. During the activities, their reflexes are tested, they are asked to move their     legs, and their legs are moved for them.   "
174391|NCT00123734|"     The assessment of patients with suspected deep vein thrombosis (DVT) is a common clinical     scenario that, despite major advances in diagnostic testing, continues to be challenging.      The diagnosis of DVT remains problematic in:        -  patients with suspected first DVT who have a moderate or high pre-test probability (PTP)          for DVT and a normal compression ultrasound (CUS);        -  patients with suspected recurrent DVT; and        -  patients in whom CUS or contrast venography is technically difficult or not feasible due          to patient characteristics.      In patients with suspected first DVT who have a moderate or high PTP and a normal CUS, DVT     occurs in up to 10% of cases. Thus, additional diagnostic testing is required, such as     venography or serial CUS, so that DVT is not missed, but these approaches are costly and     invasive.      In patients with suspected recurrent DVT, currently used diagnostic approaches are     problematic because they all have limitations in differentiating old disease from true     recurrent disease.      CUS is technically difficult in selected patients, particularly those who are obese.      Contrast venography is the gold standard diagnostic test for DVT to which all other     diagnostic venous imaging modalities for DVT are compared and judged. The Food and Drug     Administration (FDA) requires that a new diagnostic test for DVT be assessed against     venography.      [99mTc] ThromboView® is a novel diagnostic test based on a 99mTc-labeled monoclonal antibody     specific for D-dimer fragments of cross-linked fibrin that are found in acute DVT. After     intravenous injection of [99mTc] ThromboView®, there is uptake of the monoclonal antibody by     acute, D-dimer rich, venous thrombi. This is visualized with nuclear medicine imaging as an     area of increased radioisotope activity that corresponds to the location of DVT.      Based on the biologic and imaging characteristics of [99mTc] ThromboView®, this diagnostic     test has the potential to:        -  identify small non-occlusive proximal DVT or distal DVT in patients with a moderate or          high PTP and normal CUS;        -  differentiate old from new DVT in patients with suspected recurrent DVT;        -  diagnose or exclude DVT in patients in whom CUS is not technically feasible; and        -  provide an alternative to venography that is non-invasive, has no contrast-related          toxicity and is easily administered.      The present study is the first phase II clinical trial of [99mTc] ThromboView® in patients     with suspected initial or recurrent DVT in whom DVT has been confirmed or excluded by     venography. A phase II clinical trial to investigate the diagnostic accuracy of [99mTc]     ThromboView® is justified because:        -  ThromboView® was well tolerated, with no significant toxicity in studies involving          animals and healthy volunteers; and        -  it has shown promise in Phase I trials as a non-invasive diagnostic test for acute DVT.   "
174392|NCT00123747|"     At this time, computed tomography (CT) is the standard tool used at this institution for the     staging of non-small cell lung cancer (NSCLC). For most patients, treatment planning for     NSCLC is performed with the patient breathing freely during CT scanning. However, recent     research has demonstrated that, by holding one's breath briefly, the NSCLC tumor mass can be     held motionless. As a result, the tissue to be treated is better pinpointed and the area     treated is significantly decreased through breath-hold planning. This allows for a higher     dose of radiation to be given to the cancer. PET scanning is a promising newer imaging     modality which has shown to be useful in staging NSCLC. This study hypothesizes that     breath-held PET scanning and breath held-CT scanning will allow for more stringent     radiotherapy plans, minimizing normal tissue toxicity, as well as potentially increasing the     dose deliverable to the primary tumor.   "
174393|NCT00123760|"     Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses     positron emitting radiolabeled tracer molecules to measure biological activity. The most     common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to     determine abnormal glucose metabolism in tumours and other sites. It has general applications     in all areas where abnormal glucose metabolism may be present including in circumstances such     as differentiating the tumour from scar tissue; evaluating the presence of the tumour in     light of rising tumour markers and normal morphological imaging techniques; and assessing     response to therapy where other techniques are deemed to be unhelpful. The Cross Cancer     Institute (CCI) has recently been funded to establish a PET centre, and this study will prove     the effectiveness of PET scanning in the Canadian health care environment and validate the     data that have been developed in other jurisdictions in specific oncologic indications.   "
174394|NCT00123773|"     Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses     positron emitting radiolabeled tracer molecules to measure biological activity. The most     common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to     determine abnormal glucose metabolism in tumours and other sites. It has general applications     in all areas where abnormal glucose metabolism may be present including in circumstances such     as differentiating the tumour from scar tissue; evaluating the presence of the tumour in     light of rising tumour markers and normal morphological imaging techniques; and assessing     response to therapy where other techniques are deemed to be unhelpful. The Cross Cancer     Institute has recently been funded to establish a PET centre, and this study will evaluate     the effectiveness, value and safety of PET scanning in a number of uncommon cancers in the     Canadian health care environment.   "
174413|NCT00117143|"     The purpose of this study is to assess the safety, tolerability, and utility of AMG 531 unit     dosing (µg) in thrombocytopenic subjects with ITP.   "
174414|NCT00117156|"     The purpose of this study is to determine the effectiveness of six cycles of concurrent     fludarabine and rituximab in patients with mucosa-associated lymphoid tissue (MALT) lymphoma,     marginal zone lymphoma (MZL) or CD5-, CD10-, CD20+ low-grade B cell lymphomas.   "
174415|NCT00117169|"     The main hypothesis for this study is that the diagnostic approach of pulmonary embolism (PE)     by evaluation of clinical probability, D-dimer test dosage and multi-detector helical     computed tomography (hCT) is as safe as the classical approach using clinical probability,     D-dimer test, lower limb compression ultrasonography and multi-detector helical computed     tomography.      The second hypothesis involves evaluating the role of searching distal, i.e. infrapopliteal,     deep venous thromboses (DVTs) in the diagnostic approach of pulmonary embolism.   "
174395|NCT00123786|"     18F-fluorodeoxyglucose (18F-FDG) has been approved by many regulatory agencies world-wide and     is in widespread use in the United States, Japan and Europe. In the United States, 18F-FDG     scanning in oncology is approved for federal healthcare reimbursement for non-Hodgkin's     lymphoma, Hodgkin's disease, colorectal cancer, lung cancer, oesophageal cancer, melanoma,     head and neck cancer and breast cancer. It has general applications in all areas where     abnormal glucose metabolism may be present including in circumstances such as differentiating     the tumour from scar tissue; evaluating the presence of the tumour in light of rising tumour     markers and normal imaging techniques; and assessing response to therapy where other     techniques are deemed to be unhelpful. Current literature suggests that functional imaging     with 18F-FDG Positron Emission Tomography (PET) may play an important role in the imaging     evaluation of patients with soft tissue sarcoma, including guiding biopsy; detecting local     recurrence at sites of tumour resection; detecting metastatic disease; predicting and     monitoring response to therapy; and assessing for prognosis. In appropriate situations, it is     possibly the most effective diagnostic strategy. However, due to the low incidence of these     tumours, prospective studies with large multicenter patient groups will be essential to     define the exact diagnostic role of 18F-FDG PET in this clinical setting.   "
174396|NCT00123799|"     Breast cancer affects many women. One of the places to which it can spread is the lymph     glands under the arm. The type of treatment offered to patients often will depend on whether     those lymph glands have cancer in them or not. For this reason, a standard recommendation is     that women with breast cancer have these lymph glands removed with surgery. This cancer     causes side effects including numbness, pain, decreased ability to move the arm and arm     swelling. A new type of surgery which looks only at the first gland that a cancer drains to     (sentinel node biopsy) may help to avoid having to remove the glands under the arm. Also, a     new way of imaging the glands under the arm called Positron Emission Tomography (PET)     scanning may also give a better idea of the chance that these glands have cancer in them.     This study is determining whether PET scans before surgery and sentinel node biopsy can     decrease the need for a complete axillary dissection.   "
174397|NCT00123812|"     Currently in Canada, and at the Cross Cancer Institute, the treatment of many women with     breast cancer involves radiotherapy (RT). There is a complex process which takes place in     order to plan the radiation therapy before patients commence their treatment. In many     circumstances the investigators use computerized technology to assist in planning their     treatment. This allows more precision in delivering the treatment to the desired areas and     avoiding areas of normal tissue.      Once the planning process is completed, the investigators then place marks with a marker pen     on the skin of the patient to outline the area where the radiation will be delivered. The     investigators confirm that the correct area is being treated with an x-ray taken on the     treatment unit while the patient is in the treatment position. This is called a port film or     verification film. The investigators then compare this to what they set up with the     computerized data. If all the information matches, the patient is then treated for the full     course of radiation, with the assumption that all treatments are given in the correct     position. No further routine checking is done.      The standard at some radiotherapy centers is that the patient treatment position is verified     weekly by a portal film. At the Cross Cancer Institute the investigators normally only do it     once at the beginning of treatment.      No information is available to confirm the necessity of doing more frequent verification     films, but in view of the very complex nature of the investigators' treatment delivery, it     may be necessary to confirm the accuracy of their treatment more often.      Over the course of a 4-5 week treatment the investigators know that some patients may lose     weight, some become more relaxed after a few days, and some have trouble with the movement in     their shoulders; all of these factors influence the positioning of the patient. Measurements     taken on the treatment unit often change during the course of a patient's treatment, but no     further verification is performed to ensure that the treated area is still what was initially     intended. It is important from a quality assurance standpoint to see if more frequent     checking of the radiation treatment set-up is indicated.   "
174398|NCT00123825|"     In the United States, the incidence of biliary tract cancer and gallbladder cancer has been     estimated to be 6,000-8,000 patients per year. Currently, there is no standard therapy for     these tumors once the disease has spread and is inoperable. Recent small studies with     gemcitabine have shown a positive response rate. The investigators plan to test the     combination of gemcitabine with cisplatin for biliary tract and gallbladder cancers.   "
174399|NCT00123838|"     The purpose of this study is to evaluate a non-ionizing electromagnetic method to align the     prostate treatment site for radiation therapy and to monitor its position throughout     radiation therapy delivery. The clinical study involves using an investigational device, the     Calypso® 4D Localization System, and requires permanent implantation of three small sensors     called Beacon® transponders in the prostate.   "
174400|NCT00123851|"     This trial is designed to investigate the safety, tolerability and the effectiveness when     OSI-774 (tarceva) is combined with oxaliplatin and capecitabine in treating patients with     metastatic colorectal cancer.   "
174401|NCT00123864|"     One of the side effects of standard radiation therapy for cancer of the nasopharynx is a     permanent lessening of normal mouth moisture (saliva). This reduction in saliva is important     because it causes a feeling of dry mouth, and has been shown to increase the risk of dental     cavities and infections; change or decrease the ability to taste certain foods; and make     chewing and swallowing food more difficult. Recent technical advances in radiation therapy     offer the possibility of shielding a portion of one of the major salivary glands (parotid     gland) from receiving a dose of radiation that would eliminate its ability to produce saliva,     while still treating all sites of known cancer effectively. Recently, cancer researchers in     Ann Arbor, Michigan used this new treatment technique to treat patients with head and neck     cancers (but none with nasopharyngeal cancer), and found that patients treated in this manner     still had significant saliva production from the spared gland. This study will try to use the     treatment planning technique called intensity-modulated radiation therapy to protect a     portion of one parotid gland while treating all known and suspected areas of cancer to full     radiation doses.   "
174403|NCT00123890|"     The purpose of this study is to determine eligibility for one of three treatment studies of     the CCR5 antagonist GW873140 or an observational study without GW873140. No investigational     treatment will be administered through this study.   "
174405|NCT00123916|"     Evaluate if benznidazole, an antiparasite drug, given at a dose calculated as 5mg/kg/day for     60 days, now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment -     period adjusted according to the patient's body weight to a total minimum dose of 12g     (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg) - reduces     morbidity and mortality in patients with Chronic Chagas' Cardiomyopathy (CCC).      The BENEFIT study is being conducted by the Population Health Research Institute (in     Hamilton, Canada) and the Institute Dante Pazzanese de Cardiologia (Sao Paulo, Brazil)     together with an independent Steering Committee.   "
174450|NCT00117624|"     The purpose of this study is to compare the efficacy of darbepoetin alfa administered using a     front-loading approach with subjects receiving standard weekly dosing in the treatment of     anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.   "
174416|NCT00117182|"     The purpose of this study is to determine whether the Aridol (mannitol) challenge test can     predict response to treatment with inhaled corticosteroids in COPD subjects. Subjects will     undergo an Aridol test and then 3 months of treatment with inhaled corticosteroids. The     effect on lung function and quality of life will then be measured and correlated with the     Aridol test result.   "
174417|NCT00117195|"     The goal of this study is to investigate neurophysiologic tests that have the potential of     serving as screening tools for Parkinson's disease. These neurophysiologic tests will be     administered to individuals with Parkinson's disease and parkinsonian syndrome and validated     against a healthy control population.      Specifically, this study will look at changes in motor function, cognitive function,     handwriting, speech, and olfactory function in individuals with Parkinson's disease,     individuals at risk for Parkinson's disease and healthy controls.   "
174418|NCT00117208|"     The purpose of this study is to determine the medium term efficacy and safety profile of     inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In     particular, we will assess the impact on: lung function; airway inflammation; sputum     microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs     of hospital and community care; and cost-effectiveness.   "
174419|NCT00117221|"     This study will investigate the spatio-temporal characteristics of brain activity during     sleep. Functional magnetic resonance imaging (fMRI) studies have shown that in the absence of     external stimuli, the brain continues to show spatial patterns of activity that resemble     those during sensory and cognitive tasks. This phenomenon greatly affects the interpretation     of neuroimaging studies based on positive emission tomography (PET) and fMRI, which rely on     the contrast between brain activity during a task and activity during rest. In addition,     resting state activity in itself may reveal information on the large-scale organization of     neuronal networks and on functional abnormalities related to disease.      Participants should represent a broad cross section of the healthy adult population. Any     neurologically and psychiatrically healthy male or nonpregnant female between 18 and 65 years     old may be eligible.      Studies will be conducted in the In Vivo NMR Research Center. Concurrent electroencephalogram     (EEG) and MRI studies will last between 1 and 2 hours. A typical study involves 15 minutes of     anatomical MRI scanning followed by a 60-minute functional scan during which the subject     relaxes with eyes closed and is encouraged to sleep while the fMRI/EEG are performed.     Participants may be scanned 1 to 20 times. No more than 1 scan will be performed per day and     no more than 20 scans will be performed within a year. During the last 5 to 10 minutes of the     scan, the participant will open his or her eyes and actively participate in a visual     stimulation or attention task. The participant's alertness will be measured by a behavioral     (button-press) response. The visual stimuli (contrast reversing checkerboard displays,     alternated with uniform grey fields) will be presented using the standard projection system     available with the MRI scanner. The attention task will involve repeated visual presentation     of groups of letters and digits; the participant will be asked about the correspondence     between these groups.      Magnetoencephalogram (MEG) scans will be performed on some participants. The precise and     undistorted signals available with MEG will be used to enhance the interpretation of     alertness and sleep-related characteristics of the EEG signals, which can vary quite     dramatically across subjects. In addition, the MEG signals will provide preliminary spatial     localization of the sleep-dependent changes more precisely than is possible with EEG. MRI     scanner noise will be simulated using tape recordings to allow comparison with the MRI/EEG     data. MEG scans will last 45 minutes to 2 hours. At all times during any of the brain scans     the participant will be able to communicate the MRI scientist or MEG/EEG technician and can     ask to be removed from the device at any time.      The study will not have a direct benefit for participants. It may be help us learn more about     brain function, which may lead to better treatments.   "
174420|NCT00117234|"     The purpose of this study was to evaluate the effect of treatment with darbepoetin alfa on     peak oxygen consumption (peak VO2) in subjects with symptomatic CHF and anemia.   "
174423|NCT00117273|"     This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy,     reproductive-aged women using three different regimens of oral contraceptives (OCs). Two     extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days     followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg     for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia     (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).   "
174424|NCT00117286|"     This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was     to be treated until he was discontinued or withdrawn from the study, or a marketing     authorization for degarelix had been obtained.      The study was terminated when all ongoing participants had been treated for at least 5 years.   "
174425|NCT00117299|"     This study evaluates the safety and efficacy of a novel tyrosine kinase inhibitor,     PTK787/ZK222584, in the treatment of GIST (gastrointestinal stromal tumor) that is resistant     to imatinib mesylate (Gleevec). The study participants are required to have histologically     confirmed GIST with prior imatinib treatment for metastatic GIST. is administered orally 1250     mg/day. Six patients will first enter the study. If clinical benefit is obtained in >1 of 6     patients, 9 and 30 additional patients will be entered into the protocol in two stages (a     maximum of 45 patients will be entered). Patients who benefit from the study treatment will     be treated with PTK787/ZK222584 until treatment failure.   "
174426|NCT00117312|"     Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity     to continue treatment with degarelix under a clinical study until FE200486 was available on     the market or until the study was discontinued.      Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of     FE200486.   "
174427|NCT00117325|"     The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg     once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent     subjects (12 years of age and older) with vasomotor rhinitis (VMR).   "
174428|NCT00117338|"     This study will attempt to find out if the addition of an intravenous form of a drug that is     already used for treating asthma in children will help resolve asthma attacks faster than     using the current standard care alone.   "
174429|NCT00117351|"     This study will evaluate the safety and efficacy of VELCADE in patients with previously     treated stage IIIB and IV bronchioloalveolar carcinoma and adenocarcinoma with     bronchioloalveolar features.   "
174446|NCT00117572|"     The combined use of chemotherapeutic drugs with radiation has proven to be effective in     improving overall survival and local control among patients with locally advanced head and     neck cancer. Induction chemotherapy given before receiving local treatment has been shown to     reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from     growing or dividing, although it has yet to be determined which agent, or specific     combination of agents, is most effective in treating head and neck cancer. Docetaxel is a     drug which has been reported to show promising activity in Phase II head and neck cancer     studies. Therefore, the purpose of this trial is to compare the effectiveness of induction     chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in     patients with locally advanced head and neck cancer.   "
174430|NCT00117364|"     SACCHACHITIN gel, prepared from the waste residue of the fruiting body of Ganoderma tsugae,     was used in a previous study to enhance skin wound healing in animal models. In the present     study, the effects of the gel on the activity of matrix metalloproteinases (MMPs) and     vascular endothelial growth factor (VEGF) as well as on the healing of skin wounds in humans     are estimated by a clinical trial.      The hypothesis regarding the poor healing of the wound is the over-expression of MMP and the     inhibition of the angiogenic factors. From the previous animal study, the effect of     SACCHACHITIN was to inhibit the activity of MMP and stimulation of VEGF and we try to prove     the effect over the human wounds from this clinical trial.      Patients with a poorly healed wound, in which skin graft is clinically indicated, are     included in this study. The exudates from the wound are collected and analyzed for the     activity and concentration of VEGF and MMP. The change of the healing process is recorded.      Positive results are expected from the clinical trial and the patients will get another     choice for the treatment of the chronic wound other than skin grafting.   "
174431|NCT00117377|"     The purpose of this study is to identify how pimecrolimus cream 1% modifies the molecular and     cellular changes associated with the post-lesional phase of atopic dermatitis (AD). Healthy     volunteers and patients with atopic dermatitis will be studied.   "
174432|NCT00117390|"     The purpose of this study is to evaluate the optimal technique for determination of the renal     function of critically ill patients.   "
174433|NCT00117403|"     The purpose of this study is to examine the safety and effectiveness of two anti-oxidant     treatment regimens in patients with mild to moderate Alzheimer's disease. The anti-oxidant     treatments include vitamin E + C + alpha-lipoic acid, and Coenzyme Q (CoQ).   "
174434|NCT00117416|"     The purpose of this study is to evaluate the renal perfusion depending on the MAP.   "
174435|NCT00117429|"     This study will test the safety and immunogenicity of the gp120/NefTat/AS02A vaccine     candidate in individuals with chronic HIV-1 infection successfully treated with HAART. The     rationale for this study is based on previous scientific experiments, including data     indicating that this vaccine can elicit strong HIV-1-specific T cell immune responses in     humans and monkeys and lead to a retardation of HIV-1 disease progression in animal models of     HIV-1 infection.      The HIV vaccine to be administered during this study consists of three recombinant HIV clade     B viral antigens: the envelope glycoprotein gp120 and two regulatory proteins, Nef and     Tat.The antigens are formulated in a proprietary adjuvant, AS02A, comprised of two     immunostimulants in an oil-in-water emulsion (gp120/NefTat/AS02A). The vaccine and the     adjuvant are manufactured and provided for the study by GlaxoSmithKline Biologicals,     Rixensart, Belgium. The drugs will be given by intramuscular (IM) injection at a standard     dose of 20 mg together with 0.5 ml of the AS02A adjuvant.      Twenty HIV-1 infected individuals will be randomly enrolled into three different study     groups, receiving either the gp120/NefTat/AS02A vaccine (10 individuals), the AS02A adjuvant     alone (5 individuals) or a placebo (5 individuals). After obtaining informed consent,     subjects will have a history and physical exam performed and have laboratory tests to confirm     they meet all inclusion and exclusion entry criteria. Women of childbearing potential will     have a pregnancy test prior to each injection of the investigational product. Injections with     vaccine, adjuvant alone, or placebo will then be performed at weeks 0, 4, and 12. Study     participants will undergo close monitoring after each vaccination. Blood samples will be     obtained for immunological assays at study baseline (2 times) and weeks 2, 4, 6, 12, 14, 24,     and 48. All patients will maintain their antiretroviral treatment regimen during the entire     study period.   "
174436|NCT00117442|"     The purpose of this study is to provide dose-finding information regarding the efficacy and     kinetics of peripheral blood progenitor cell (PBPC) mobilisation by pegfilgrastim and to     determine if carboplatin/paclitaxel can be delivered at a reduced cycle interval when     supported by pegfilgrastim-mobilised PBPCs in whole blood.   "
174437|NCT00117455|"     The purpose of this study is to evaluate the ability of two different fixed doses of     pegfilgrastim (6mg and 12mg) and a by-weight dose of filgrastim (5ug/kg/day) for the     mobilisation and collection of PBPCs for autologous transplantation after chemotherapy.   "
174438|NCT00117468|"     This is a single-center, open-label, randomized, active-controlled study to compare DR-2011     to progesterone vaginal gel for luteal phase replacement.   "
174440|NCT00117494|"     In HIV hypercholesterolemic patients treated with protease inhibitors, some drugs of the     statin group are used to control cholesterol level. New and potentially more efficient     statins may interfere with protease inhibitors and hence loose a part of their activity. They     have thus to be compared with a more established drug of the same class (e.g. pravastatin).     The protocol compares the efficacy and safety of rosuvastatin and pravastatin.   "
174441|NCT00117507|"     Thirty patients will be enrolled into this open-label, single-arm trial designed to assess     the safety and tolerability of oral deferasirox in adult transfusion dependent     myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this study     will have low or intermediate (INT-1) risk MDS per International Prognostic Scoring System     (IPSS) criteria. All patients will initiate treatment with 20mg/kg/day deferasirox.      Deferasirox will be administered orally once per day for 12 months.   "
174442|NCT00117520|"     The study investigated the effect of caffeine on physical performance in healthy citizens     aged over 70 years. The main hypothesis was that 6 mg/kg caffeine would improve cycling     endurance at 65% of expected maximal heart rate.   "
174443|NCT00117533|"     The treatment of choice for chronic hepatitis D is uncertain. The investigators hypothesize     that pegylated interferon (IFN) alfa-2b in combination with ribavirin (RBV) may be effective     in the treatment of chronic hepatitis D patients who are also infected by hepatitis B virus     (HBV). The purpose of this study is to test this hypothesis. The investigators will use     pegylated IFN alfa-2b in combination with RBV for the treatment of patients with dual chronic     hepatitis D virus (HDV) and HBV infection. A 24-week course of combination therapy pegylated     IFN+RBV will be used.   "
174444|NCT00117546|"     A history of preeclampsia is associated with a low plasma volume and higher sympathetic     activity. Methyldopa will suppress sympathetic activity to normal values. In this study, the     researchers will test that effect on the total cardiovascular balance.   "
174445|NCT00117559|"     The purpose of this study is to evaluate a group psychotherapy intervention and a telehealth     intervention for veterans undergoing interferon treatment for the hepatitis C virus. It is     hypothesized that the cognitive behavioral therapy (CBT) condition and the telehealth     condition will result in significantly improved outcomes, including enhanced adherence,     quality of life, and psychological status.   "
174447|NCT00117585|"     The purpose of this study is to determine the prevalence and clinical course of orthostatic     hypotension (OH) on a rehabilitation and nursing home unit during their inpatient stay and to     initiate a standardized, interdisciplinary treatment plan for patients with OH and determine     the effect of treatment on the clinical course of OH during their inpatient stay.   "
174451|NCT00117637|"     The purpose of the study is to:        -  Find out if patients receiving BAY43-9006 will live longer without tumor progression          than those receiving standard therapy with interferon alpha-2a        -  Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who          progressed during standard dose treatment with BAY43-9006, and for how long these          patients live without progression        -  Find out how long patients live without progression who receive BAY43-9006 after failing          to respond to standard therapy with interferon alpha-2a        -  Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks          kidney tumors and/or their metastases depending on treatment and dosage        -  Find out if BAY43-9006 has any effect on the quality of life of patients with kidney          cancer        -  Find out the level of BAY43-9006 in the blood once per month and any changes in this          level        -  Find out whether BAY43-9006 effects are associated with specific biomarkers   "
174452|NCT00117650|"     The purpose of this Phase 2 clinical research study is to examine the safety of an     experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of     new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt     to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD).      Specifically, this study will enroll patients with severe intermittent claudication (IC)     which is the stage of PAD in which a patient's walking ability is severely limited, causing     pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower     limbs.   "
174453|NCT00117663|"     The purpose of this study is to determine whether cessation of hormone replacement therapy     for one or two months before a screening mammogram will improve its performance by decreasing     breast density.   "
174454|NCT00117676|"     This primary objectives of this study are to compare the efficacy, safety, and tolerability     of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of     pre-core mutant chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks     (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to     480 weeks.   "
174687|NCT00126932|"     Children ages 3-7 who are undergoing blood drawing receive either standard care, topical     medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the     onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing procedure     is evaluated.   "
174455|NCT00117689|"     This study involves the use of a drug called Thymoglobulin, which is approved in the US to     treat kidney transplant rejection and in Canada to treat and prevent kidney transplant     rejection. This study will evaluate the effect of Thymoglobulin induction therapy and reduced     doses of calcineurin inhibitors on the incidence of liver rejection and will provide a basis     for future evaluations of Thymoglobulin as an immunosuppressive agent to help decrease the     incidence of liver transplant rejection. Subjects meeting all inclusion and exclusion     criteria are eligible to participate in this study. Approximately 75 study subjects from up     to 18 transplant centers in the United States and Canada will be enrolled in this 12-month     study.   "
174456|NCT00117702|"     The purpose of this pilot study is to provide preliminary data about the efficacy and the     safety of the combination of tacrolimus with everolimus in the prophylaxis of the     graft-versus-host-disease (GvHD) in patients after allogeneic stem cell transplantation.   "
174457|NCT00117715|"     This is a drug metabolism study in one-year old children involving caffeine and     dextromethorphan.   "
174458|NCT00117728|"     This study is designed to test if a sequential protease-inhibitor (PI) - / nevirapine (NVP)     -based regimen is effective for the treatment of HIV-infected children when previous NVP     exposure has occurred as part of programs to prevent mother-to-child transmission (pMTCT).   "
174459|NCT00117741|"     The purpose of this study is to compare a one year treatment program of Dialectical Behavior     Therapy (DBT) + suboxone for opiate addicted individuals meeting criteria for borderline     personality disorder (BPD) to a one year program of standard drug counseling (I/GDC) +     suboxone.   "
174460|NCT00117754|"     Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily     in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules     and pruritus are the primary clinical signs which can be associated with tinea capitis. The     infection is caused by a relatively small group of dermatophytes in the genera Trichophyton     and Microsporum.      Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study     will evaluate the efficacy and safety of terbinafine in children with tinea capitis.   "
174461|NCT00117767|"     Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily     in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules     and pruritus are the primary clinical signs which can be associated with tinea capitis. The     infection is caused by a relatively small group of dermatophytes in the genera Trichophyton     and Microsporum.      Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study     will evaluate the efficacy and safety of terbinafine in children with tinea capitis.   "
174462|NCT00117780|"     This trial is conducted in Europe. The aim of this research study is to compare the efficacy     (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection     compared to insulin detemir twice daily injection administered as basal insulin for the     treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes     of hypoglycemia, body weight and side effects).   "
174463|NCT00117793|"     The fit of the residual limb within a prosthetic socket is a primary concern for many     amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further,     amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy     residual limb tissue; a condition that could be mitigated by the application of negative     pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual     limb response to a vacuum suspension system and to measure prosthetic performance in     comparison to a typical suction suspension system.      The proposed research plan involves two sets of human subject experiments: (1) prospective,     randomized cross-over study to quantify performance of a vacuum suspension system as compared     to a total surface bearing suction socket in terms of pistoning, maintaining limb volume,     step counts, and subjective measures of fit and (2) measurement of transcutaneous oxygen     tension as a function of vacuum pressure.   "
174464|NCT00117806|"     This study involves research about how to help Veterans with spinal cord injury (SCI) gain     employment. During the first couple of years following SCI, many people are concentrating on     their rehabilitation and are unable to afford the time for return to work. However, studies     have shown people often regain the necessary strength and function about two years after SCI     to resume activities of daily living very similar to what they experienced prior to the SCI.     Even though many social and legal efforts have been made in the last decade to improve     chances for people with disabilities to return to work, Veterans with SCI are sometimes     hindered in finding employment because of age, past work history, and many other factors.     Other Veterans with SCI are very successful at finding employment either working for     themselves or working for a company. The investigators know very little about what issues     Veterans with SCI face when they attempt to find employment after SCI. The study will analyze     both quantitative and qualitative measures to maximize its findings.   "
174465|NCT00117819|"     This study involves study participants who have been clinically diagnosed with parkinsonian     syndrome or who are at-risk for parkinsonian syndrome, have a family history of parkinsonian     syndrome or exposure to environmental toxins potentially associated with parkinsonian     syndrome. Participants will have brain imaging to assess dopamine transporter density. The     imaging data coupled with family history and environmental exposure data may provide     important information about potential risk factors for parkinsonian syndrome.   "
174466|NCT00117832|"     Eye symptoms of tearing, redness and itching frequently occur in patients with allergic     rhinitis or hayfever. The purpose of this trial is to study whether placing an allergen (a     substance that causes allergies) directly in your nose can cause you to have eye symptoms as     well as nasal symptoms.   "
174477|NCT00117975|"     RATIONALE: Monoclonal antibodies, such as rituximab and galiximab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Giving more than one     monoclonal antibody may be a better way to block cancer growth.      PURPOSE: This phase II trial is studying how well giving rituximab together with galiximab     works in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.   "
174736|NCT00127166|"     The purpose of this study is to determine the effect of four weeks of treatment with two     investigational drugs (oral versus inhaled administration) plus an inhaled medication in the     treatment of airway constriction brought on by exercise in participants with asthma.   "
174467|NCT00117845|"     Adult T-cell leukemia (ATL) is and aggressive characterized by the presence of cluster of     differentiation 4 (CD4)/cluster of differentiation 25 (CD25)-expressing T cells     (interleukin-2 [IL-2]R expressing) in the peripheral blood and in lymphoid and other tissues.     Denileukin diftitox (Ontak(Registered Trademark)) is a genetically engineered fusion protein     that targets IL-2-expressing malignancies. Denileukin diftitox interacts with the IL-2R on     the cell surface, is internalized via endocytosis, and inhibits cellular protein synthesis,     resulting in cell death within hours to days. The objectives of this study are to determine     the clinical response to Denileukin diftitox of patients with adult T-cell leukemia (ATL) and     the safety of Denileukin diftitox in those patients.      Eligible participants must be 18 years of age or older with chronic, lymphomatous and acute     forms of ATL, and must be infected with human T-cell lymphotropic virus type I (HTLV1).      Patients will be treated with 9 mcg/kg/d of Denileukin diftitox intravenously for 5 days     every 2 weeks. Tumor response will be evaluated after two cycles of treatment. Stable or     responding patients will continue treatment for a total of 12 months, with evaluations every     four cycles of treatment. Patients will be treated for two cycles beyond a complete     remission. The trial uses an optimal two-stage design targeting for a true response     proportion of more than 30 percent. Nine patients will be treated initially, with expansion     to 29 patients if a response is seen in 1 of the initial 9 patients treated. Treatment will     be discontinued if a patient experiences serious side effects.      A potential benefit is that a patient may undergo partial or complete remission. The research     may not directly benefit participants, but the results may aid in the treatment of others.   "
174468|NCT00117858|"     This project is designed to test how direct current (DC) electrical polarization of the brain     affects language and behavior in patients with frontotemporal dementia (FTD). FTD is the     second most common form of dementia after Alzheimer's disease. It causes profound     disturbances of language and other cognitive functions and often results in highly disruptive     behavior. There is no effective treatment for the behavioral disorder or cognitive deficits     in FTD. In an earlier study, the researchers used DC polarization to the primary motor cortex     to enhance prefrontal function in healthy subjects. The experiment resulted in greater verbal     fluency. In a separate study of five patients with FTD, a similar effect on verbal fluency     was produced. The object of the current study is to replicate these findings in a larger     group of patients and to see if the results carry over into real world behavior.      Participants will be 20 patients aged 35 to 75 years with FTD, referred to the Cognitive     Neuroscience Section.      Participants will be tested in two sessions, separated by at least 48 hours. In one session     they will receive 40 minutes of anodal DC polarization; in the other they will receive 40     minutes of sham polarization. Participants will be tested for language, memory, and reaction     time before and 20 minutes after the polarization. For the behavior portion of the study, the     Neuropsychiatric Inventory will be completed by an investigator with the caretaker on     admission (covering the preceding week) and again, by telephone, 1 week after discharge, to     cover the first week home.      Participants will receive no lasting benefit as a result of the study, but the study is     likely to yield generalizable knowledge on the effects of DC polarization treatment in FTD.   "
174469|NCT00117871|"     The primary purpose of this study is to evaluate the effectiveness in adults of 2 different     strengths of resiquimod gel applied to common wart(s) five times a week for up to 12 weeks.      A second purpose is to evaluate the safety of the drug.   "
174470|NCT00117884|"     The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations     and dosing regimens on high-risk cervical human papillomavirus infection in women.   "
174677|NCT00126802|"     Helical tomotherapy is being used to treat the prostate gland, local rates of spread and     regional lymph nodes whilst sparing gross structures. The radiation to the gross disease in     the prostate is hypofractionated and dose escalated. Magnetic resonance spectroscopic imaging     (MRSI) is incorporated into pre- and post-treatment evaluation.   "
174471|NCT00117897|"     This multicenter, open-label, randomized, parallel study was designed to evaluate whether a     single fixed-dose subcutaneous (SC) administration of pegfilgrastim or daily administration     of Filgrastim for absolute neutrophil count (ANC) support would assist in allowing the     planned dose-on-time (PDOT) of cyclophosphamide, doxorubicin, vincristine, prednisolone     (CHOP) chemotherapy with Rituximab every 14 days in subjects with aggressive B-cell     Non-Hodgkin's Lymphoma by reducing the duration of neutropenia and incidence of febrile     neutropenia.   "
174472|NCT00117910|"     This open-label, multicenter study explored primary and secondary prophylaxis treatment with     a single, fixed-dose, subcutaneous (SC) injection of pegfilgrastim in elderly subjects with     high-risk breast cancer receiving myelosuppressive chemotherapy. The primary objective was to     provide preliminary information on the incidence of protocol defined neutropenic events in     chemotherapy cycle 1.   "
174473|NCT00117923|"     The primary purpose of this study is to evaluate the effectiveness in adults of four     different strengths of resiquimod gel applied to common wart(s) five times a week for four     weeks.      A second purpose is to evaluate the safety of the drug.   "
174474|NCT00117936|"     Treatment for no-option heart patients with coronary artery disease. Procedure includes the     injection into the heart of a protein growth factor, administered by the Cordis Corp. MyoStar     injection catheter, to stimulate the growth of blood vessels around blocked coronary     arteries.   "
174475|NCT00117949|"     Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486     CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both     studies were to guide dose selection for phase III. In addition, safety and tolerance data     were generated.   "
174476|NCT00117962|"     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Cetuximab may also make tumor cells more sensitive to     radiation therapy. Giving pemetrexed disodium, carboplatin, and radiation therapy together     with cetuximab may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium and     carboplatin together with radiation therapy with or without cetuximab works in treating     patients with stage III non-small cell lung cancer that cannot be removed by surgery.   "
174737|NCT00127179|"     The purpose of this trial is to determine the efficacy and safety of an investigational drug     in patients with benign prostatic hyperplasia.   "
174478|NCT00117988|"     This phase II trial is studying how well 17-AAG works in treating patients with relapsed or     refractory anaplastic large cell lymphoma, mantle cell lymphoma, or Hodgkin's lymphoma. Drugs     used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing.   "
174479|NCT00118001|"     The purpose of this study is to compare the effects of worry exposure with the effects of     applied relaxation in patients with generalized anxiety disorder.   "
174480|NCT00118014|"     The purpose of this study is to assess the extent of symptom remission in patients with     trichotillomania following treatment with sertraline and/or behavior therapy.   "
174481|NCT00118027|"     SUMMARY      Background: Malaria is the leading cause of morbidity and mortality among pregnant women in     Uganda. Although effective tools for prevention and control of malaria exist, their delivery     presents a problem. Intermittent presumptive treatment (IPT) with sulfadoxine-pyrimethamine     (SP) is effective, yet >60% of women in Uganda do not get it as < 40%, attend antenatal care.     Effective ways of delivering IPT with SP to pregnant women at a community level need to be     developed. This study assessed whether community based resource persons like traditional     birth attendants (TBAs), community reproductive health workers (CRHWs), adolescent peer     mobilizers (APMs) and drug-shop owners (DSV) can distribute IPT with SP to pregnant women.      Objectives: The objectives of this study were:        -  To assess community based approaches for delivering malaria prevention to pregnant women          in Uganda;        -  To assess community perceptions, beliefs and practices associated with malaria treatment          and prevention in pregnancy;        -  To assess whether community based resource persons can deliver IPT to pregnant women and          reach those most at risk;        -  To assess the impact of IPT on anaemia and pregnancy outcome;        -  To estimate cost-effectiveness of the approaches and assess the acceptability and          sustainability of the approaches.      Methods: The study was conducted in 5 sub-counties of the Mukono district, situated on the     shores of L. Victoria in Central Uganda. The district is hyper-endemic for malaria. 25     parishes with a total population of 75,000 people were used to test the new approaches. Phase     1 obtained qualitative data on community perceptions, beliefs and practices associated with     malaria prevention in pregnancy. Phase 2 was an intervention study that assessed distribution     of IPT to pregnant women by TBAs, CRHWs, APMs and DSVs compared with health units. Pregnant     women of all parities were enrolled. Key resource persons in each parish were identified to     sensitise the communities on the intervention. Data was collected regarding: timing of the     first dose of SP, proportion of women who complete two doses of SP, birth weight of babies,     proportion of low birth-weight babies, and proportion of adolescent pregnancies. The third     phase of the study evaluated the sustainability of the approaches.      Work Plan: The first phase of the study took two months. The second phase took 14-16 months.     Data analysis was expected to take 12 months.   "
174482|NCT00118040|"     Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may     help doctors learn more about changes that may occur in DNA and identify biomarkers related     to cancer. It may also help doctors learn how genistein or placebo works in patients with     bladder cancer. This randomized phase II trial is studying genistein or placebo to compare     how they work in patients who are undergoing surgery for bladder cancer.   "
174483|NCT00118053|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving trastuzumab together with     docetaxel and carboplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel     and carboplatin works in treating women with stage II, stage III, or inflammatory breast     cancer.   "
174484|NCT00118066|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of calcitriol may prevent prostate cancer. It is not yet known     whether calcitriol is more effective than observation in preventing prostate cancer.      PURPOSE: This randomized phase II trial is studying how well calcitriol works in preventing     prostate cancer in patients with prostatic intraepithelial neoplasia.   "
174678|NCT00126815|"     Clinical data are being used to build a mathematical model to describe the clinical results     of radiotherapy for prostate cancer.   "
174485|NCT00123981|"     Background: Coronary artery bypass grafting (CABG) can be performed either with or without     the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. The     investigators hypothesize that CABG without the use of CPB may reduce the risk of     perioperative death, stroke, myocardial infarction and other serious complications.      The aim of the present study is to compare the incidence of complications and the clinical     efficacy of CABG with and without the use of CPB in elderly patients.   "
174486|NCT00123994|"     The aim of this study is to determine, in the framework of a randomized controlled clinical     trial, whether Tai Chi can affect measurable improvements in self-reported outcomes such as     pain, physical function and psychological well-being in people with osteoarthritis (OA)     mainly affecting the hips or knees. The effectiveness of Tai Chi will be compared with both a     non-intervention control group as well as with a formal exercise program, hydrotherapy.     Hydrotherapy has long been considered an effective intervention for people with chronic OA     although scientific evidence is weak at present. The main study hypotheses are that Tai Chi     or hydrotherapy can significantly decrease pain and physical limitations; improve     health-related quality of life; and promote psychological well being in patients with OA of     the hip(s) or knee(s); and that Tai Chi and hydrotherapy are of equal efficacy.   "
174487|NCT00124007|"     The purpose of this study is to determine the safety of and immune response to an     investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational     HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.   "
174488|NCT00124020|"     Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug,     telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.   "
174489|NCT00124033|"     This study is designed to assess whether a new technique called facilitated endoscopic     retrograde cholangiopancreatography (ERCP) is or is not superior to conventional ERCP for     removing stones found in the bile duct at the time of laparoscopic cholecystectomy. ERCP is     an endoscopic procedure used to facilitate the radiological examination and subsequent     manipulation of the common bile duct (eg. opening it up, which is called sphincterotomy).     Both facilitated and conventional ERCP are performed as a separate procedure after the     initial gallbladder surgery. This is a comparative study of these two techniques in a     randomised clinical trial.      The aim of this randomised clinical trial is to enable surgeons to decide whether placement     of a plastic stent at the time of laparoscopic cholecystectomy will improve the success rate     and safety of subsequent ERCP and sphincterotomy.   "
174490|NCT00124046|"     The purpose of this study is to determine whether surgical section of the filum terminale in     children, when added to standard medical therapy, will result in a reliable and     clinically-significant improvement in two main markers of incontinence within/at 12 months     after treatment.   "
174491|NCT00124059|"     The purpose of this study is to determine whether seroquel is effective in the treatment of     type A and type B alcohol dependence.   "
174492|NCT00124072|"     SEARCH is a randomised, double-blind, multi-centre United Kingdom (UK) trial of 12,064     patients with myocardial infarction (MI) prior to study entry which aims to demonstrate     whether a more intensive cholesterol lowering regimen using 80 mg simvastatin daily produces     a larger and worthwhile reduction in cardiovascular events compared with a standard 20 mg     daily regimen and whether reducing blood homocysteine levels with a daily dose of folic acid     2 mg + vitamin B12 1 mg compared with matching placebo produces a worthwhile reduction in     vascular disease.   "
174493|NCT00124085|"     This is a health services demonstration project that evaluates three methods of health care     delivery for the management of individuals with symptoms of asthma. This study will evaluate     the impact of a telephonic asthma disease management process, with and without a home     intervention program, on preventing asthma-related morbidity through patient/family asthma     education.      The investigators' central thesis is that comprehensive clinical disease management protocols     for the management of asthma will improve clinical outcomes; reduce fiscal resource     consumption; and improve both patient satisfaction and patient quality of life. Additionally,     individualized, in-home patient education and environmental assessment, when added to the     telephonic protocol, will further improve these measures. However, incremental improvement     will vary according to the population's access to care.   "
174494|NCT00124098|"     The purpose of this study is to assess if Aranesp® administered once every 4 weeks to chronic     kidney disease subjects is safe and efficacious in maintaining haemoglobin levels greater     than or equal to 100 g/L.   "
174495|NCT00124111|"     The purpose of this study is to assess the relative dose intensity (RDI) of intravenous (IV)     CMF on a Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with     stage I-III breast cancer.   "
174496|NCT00124124|"     In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or     dendritic cells as adjuvants. This randomized trial will establish the safety of both     vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.   "
174497|NCT00124137|"     The purpose of this study is to compare patients who are suffering from heart failure and who     are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid     as measured by weight loss while in the hospital and improve the patient's breathing.   "
174498|NCT00124150|"     The IMASH trial is a simple, randomized, double-blinded, placebo-controlled, multi-center     trial to answer the question: Does intravenous magnesium sulfate improve clinical outcome     after aneurysmal subarachnoid hemorrhage?   "
174519|NCT00124722|"     The primary purpose of this study is to evaluate the time course of muscle relaxation after     administration of three different single intravenous bolus doses of rocuronium bromide for     intubation (insertion of a tube through the nose or mouth into the trachea to provide     artificial ventilation) in term neonates (birth to <28 days old), infants (28 days to <=3     months) and toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11     years of age), and adolescents (>11 years to less than or equal to 17 years of age).      Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg,     0.6 mg/kg, or 1.0 mg/kg.   "
174693|NCT00127010|"     This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK)     Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy     children in their second year of life.   "
174499|NCT00124163|"     Computed tomography (CT) colonography has gained widespread multi-disciplinary interest as an     evolving noninvasive colorectal screening examination, with the potential of improved patient     compliance. The investigator's prior work demonstrated that the bowel preparation was the     least tolerable aspect of colorectal evaluation when compared to the CT colonography and     optical colonoscopy procedures. Stool tagging could provide a more gentle and efficient bowel     preparation, with fewer false positives due to retained stool-mimicking polyps.      The researchers hypothesize that image quality and patient preference will vary with stool     tagging concentration and dosing schedule. The researchers propose to evaluate specific stool     tagging protocols with the following aims:      AIM 1: Perform a randomized trial of three specific stool tagging protocols using barium and     iodine at CT colonography in a well-characterized cohort of patients undergoing colorectal     evaluation.      AIM 2: Analyze the CT colonography and optical colonoscopy data to assess differences across     stool tagging protocols for the outcome measures of patient preference, image quality in the     presence of tagging, and diagnostic reader performance.      The researchers will use specific variations in stool tagging techniques to determine the     best image quality of CT data (e.g., homogenous tagging of fluid and stool), and highest     patient acceptability, as well as evaluate the adequacy of preparation for same-day     colonoscopy. Diagnostic reader performance will focus on the accuracy for detecting all     neoplastic lesions including colon cancers, adenomatous polyps, sessile adenomas and flat     adenomas. Most importantly, these results will help inform the design of a larger trial of an     optimized CT colonography technique in a community setting.   "
174500|NCT00124176|"     This study will use a randomized, double-blind, controlled trial design in order to assess     the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when     delivered continuously in a high-dose regimen for children with severe exacerbations of     asthma.      Primary hypothesis        -  Children with severe asthma receiving continuous levalbuterol will have a shorter          duration of continuous therapy as compared to racemic albuterol.      Secondary hypotheses        -  Children receiving continuous levalbuterol will have improved lung function measured by          forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol.        -  Children receiving continuous levalbuterol will have improved clinical asthma score as          compared to racemic albuterol.   "
174501|NCT00124189|"     The purpose of this study is to determine the safety and maximum tolerated dose of GRN163L in     treating patients with refractory or relapsed chronic lymphoproliferative disease.   "
174502|NCT00124202|"     This study is to determine if a fatty meal would improve the ERCP procedure.   "
174503|NCT00124215|"     The GI-5005 therapeutic vaccine or placebo will be injected under the skin of hepatitis C     virus (HCV) subjects. Patients will be monitored for safety, immune responses and any     therapeutic benefits related to the injections.   "
174513|NCT00124618|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation     therapy works in treating patients with stage III non-small cell lung cancer.   "
174688|NCT00126945|"     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one     dose of four different formulations of the MenACWY conjugate vaccine when given to healthy     subjects aged 15-19 years. The selection of the best formulation will be based on data     obtained up to one month after the vaccine dose.   "
174504|NCT00124228|"     Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe     circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal     failure is an important prognostic marker, representing the major predictive factor of     in-hospital mortality.      Recent studies have shown that plasma volume expansion with albumin associated with     cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime     treatment alone. The in-hospital and three-month mortality rates, furthermore, were     significantly lower in the group treated with albumin.      It is not known if other bacterial infections unrelated to SBP represent a risk factor for     the development of renal failure among cirrhotic patients. The researcher's group has     recently performed a study to evaluate the incidence, characteristics and outcome, of renal     failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with     the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of     106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure     was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/-     0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important     activation of endogenous vasoconstriction systems. The three-month survival probability of     patients with infection and renal failure was 34 %, much lower than that of patients with     infection but not presenting renal failure (87%, p<0.0001). These results suggest that the     development of renal failure in patients with cirrhosis and bacterial infections different     from SBP, associated with signs of a systemic inflammatory response, is very frequent and     results in a very poor prognosis. Taken as a whole, these data strongly indicate the need to     consider these patients as candidates for liver transplantation and to plan strategies for     its prevention.      The objective of this project, therefore, is to evaluate if the plasma volume expansion with     albumin, associated with conventional antibiotic therapy, can prevent the development of     renal failure and increase survival rates in cirrhotic patients with bacterial infections     unrelated to spontaneous bacterial peritonitis.   "
174505|NCT00124241|"     This is an extension study for patients who have previously completed Idenix Study     NV-02B-003. This study is being conducted to compare the safety and effectiveness of     treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug     currently approved for the treatment of hepatitis B.   "
174506|NCT00124254|"     A procedure called silicone metacarpophalangeal joint arthroplasty (SMPA) is sometimes used     to treat knuckle deformity in the hands of rheumatoid arthritis (RA) patients. The purpose of     this study is to compare the health outcomes of RA patients who choose to undergo SMPA     surgery to RA patients who do not undergo surgery.   "
174507|NCT00124267|"     Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality     rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral     malaria. However its administration is often not feasible due to lack of simple equipment or     trained staff. When referral is not possible, a viable alternative is needed. The intrarectal     route is of interest in children since it is painless and simple. Studies of the efficacy of     intrarectal quinine in the treatment of cerebral malaria are limited. The study aims to     establish the efficacy of intrarectal quinine in the treatment of childhood cerebral malaria.   "
174532|NCT00124891|"     To determine whether the administration of test article will decrease the occurrence of     ventricular arrhythmias in patients who have acute coronary syndrome (unstable angina, ST     segment elevated myocardial infarction or myocardial infarction without ST elevation).   "
174508|NCT00124280|"     This study will evaluate the efficacy and safety of everolimus treatment of patients with     advanced NSCLC. The rationale for investigating everolimus in advanced NSCLC previously     treated with chemotherapy or chemotherapy plus EGFR inhibitors, like gefitinib or erlotinib,     is based on following:        -  The medical need for the better therapy for advanced NSCLC and limited efficacy of the          currently available therapy in advanced NSCLC.        -  Postulated association of relevant cell-signaling pathways targeted by everolimus with          different aspects of oncogenesis, disease progression, and response/resistance to          treatment.        -  Effectiveness of everolimus and rapamycin in preclinical models of lung cancer        -  Early reports of clinical responses to monotherapy with mTOR inhibitors in advanced          NSCLC.      There is evidence that an enhanced PI3K/Akt/mTOR pathway, which is inhibited by everolimus,     may be one of the key changes accounting for different aspects of oncogenesis, disease     progression, and response/resistance to NSCLC cancer treatment. The use of the mTOR inhibitor     everolimus in treatment of advanced NSCLC would be a novel therapeutic approach that proposes     to logically manipulate the cell's regulatory pathways to enable control of tumor growth.   "
174509|NCT00124293|"     This study is conducted in North America. The purpose of this study is to evaluate the     occurrence and severity of bleeding in brain injury and to identify important safety issues     following traumatic brain injury.   "
174510|NCT00124306|"     This is a randomized clinical trial study to test the efficacy and safety of amitriptyline in     the treatment of patients newly diagnosed with painful bladder syndrome (PBS). PBS is defined     by symptoms--frequent urination day and night and increasing pain as the bladder     fills--according to the International Continence Society. The syndrome includes interstitial     cystitis (IC), which has been estimated to affect as many as 700,000 people, mostly women.     Estimates for PBS vary widely, but as many as 10 million people may suffer from this     condition. Although amitriptyline is a Food and Drug Administration (FDA)-approved medication     used for depression, the way it works makes it useful for treating the pain of fibromyalgia,     multiple sclerosis, and other chronic pain syndromes. Prior small studies in interstitial     cystitis (IC) suggested the drug may be a wise choice for this syndrome as well, because it     blocks nerve signals that trigger pain and may also decrease muscle spasms in the bladder,     helping to relieve the symptoms of pain and frequent urination.   "
174511|NCT00124579|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Biological therapies, such as thalidomide, may stimulate the immune     system in different ways and stop cancer cells from growing. It may also stop the growth of     cancer by blocking blood flow to the cancer. Drugs used in chemotherapy, such as     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Giving bortezomib together with thalidomide and     dexamethasone may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide     and dexamethasone works in treating patients with relapsed or refractory multiple myeloma.   "
174512|NCT00124605|"     Drugs used in chemotherapy, such as arsenic trioxide and pamidronate, work in different ways     to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Arsenic trioxide and pamidronate may also stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Pamidronate may also stop the growth of     cancer cells by blocking blood flow to the cancer. Giving arsenic trioxide together with     pamidronate may kill more cancer cells. This phase I trial is studying the side effects and     best dose of arsenic trioxide and pamidronate in treating patients with advanced solid tumors     or multiple myeloma   "
174591|NCT00125658|"     The results of this study will provide sound, scientific evidence of physiologic mechanisms     responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular     adaptation; and will elucidate the relationship between impairment and motor disability in     post-stroke hemiparesis.   "
174514|NCT00124644|"     RATIONALE: Drugs used in chemotherapy, such as cytarabine, daunorubicin, and etoposide, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Tipifarnib may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth. Giving combination chemotherapy together with     tipifarnib may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when     given together with combination chemotherapy in treating patients with newly diagnosed acute     myeloid leukemia.   "
174515|NCT00124657|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth and by     blocking blood flow to the tumor. It may also make tumor cells more sensitive to radiation     therapy. Giving radiation therapy together with erlotinib may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when     given together with radiation therapy and to see how well they work in treating young     patients with newly diagnosed glioma.   "
174516|NCT00124683|"     Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to     quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR     (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping     schizophrenic individuals quit smoking. In addition, this study will evaluate how the     combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.   "
174517|NCT00124696|"     Cocaine has been cited as the primary drug threat in the United States. The purpose of this     study is to determine if cocaethylene, used as a prototype drug, is a safe and effective     treatment for cocaine dependence.   "
174518|NCT00124709|"     This study consists of a 3-year double-blind phase during which patients will receive atopic     dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or     with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year     open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the     double-blind phase, the two treatment groups will be compared with respect to their efficacy     in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years     will be compared.   "
174583|NCT00125554|"     The purpose of this study is to test whether metyrapone is an effective and safe augmenting     agent in the treatment of major depression.   "
174520|NCT00124735|"     The primary purpose of this study is to determine the dose requirements of rocuronium bromide     when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube     through the nose or mouth into the trachea to provide artificial ventilation) and when     administered by either continuous infusion or bolus doses for maintenance of muscle     relaxation in term neonates (birth to <28 days old), infants (28 days to <=3 months) and     toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11 years of     age), and adolescents (>11 years to less than or equal to 17 years of age).   "
174521|NCT00124748|"     This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients     with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP)     using molecular endpoints.   "
174522|NCT00124761|"     This study examines surgery versus radiosurgery (highly focussed radiation) for the treatment     of cancer which has spread to one spot in the brain (solitary brain metastasis). For these     two treatment options, it will compare patients' survival times, quality of life, control     rate of the brain metastases and side effects. It uses the most rigorous scientific method     available called randomisation which minimises biases that exist with other types of     studies. It will involve 30 - 40 patients.   "
174523|NCT00124774|"     This is a prospective randomised double blind comparison trial. Fifty patients will be     included, 25 in the nucleoplasty treatment group, 25 in the control group. The nucleoplasty     group will undergo the nucleoplasty treatment. Control group will undergo a sham treatment.     Both groups will undergo a standardised post-operative care program. The study hypothesis is     that nucleoplasty will lead to earlier pain reduction as compared with the sham treatment.   "
174524|NCT00124787|"     Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an     ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by     the vestibular system, which is rich in histamine receptors. Multiple studies have shown its     effectiveness in treatment of post-operative nausea and vomiting in children. It is also used     for treatment of vertigo in children. Furthermore, it has the potential to be much more     cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal     side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and     insomnia have also been described in children. To date, there has been no published data on     the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis.      RESEARCH QUESTION      Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less     vomiting episodes than children treated with placebo?   "
174525|NCT00124800|"     The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT)     as a treatment of chronic tinnitus in people with limited hearing loss. The study design is     prospective, randomized, double-blind, with repeated measures. The null hypothesis states     there will be no difference in subjective measures of tinnitus severity between subjects     treated with standard TRT and subjects treated with sham TRT.   "
174526|NCT00124813|"     Background: In some studies, thalidomide in combination with chemotherapy has been shown to     be effective in patients with relapsed or refractory multiple myeloma (MM). In this study,     the researchers have chosen a regimen which can be administered on an outpatient basis.      Induction therapy: To evaluate the efficacy and toxicity of thalidomide, cyclophosphamide,     oral idarubicin and dexamethasone (T-CID) in patients with relapsed or refractory multiple     myeloma.      Maintenance therapy: Randomized trial to compare efficacy and toxicity of thalidomide and     thalidomide plus oral idarubicin as maintenance therapy in patients with at least stable     disease after T-CID.   "
174527|NCT00124826|"     High blood sugar (hyperglycaemia) affects 40% of acute stroke patients and has a major     adverse effect on survival and recovery. Increased production of lactic acid in brain tissue     that has a poor blood supply is postulated to be the mechanism by which high blood sugar may     worsen brain injury after stroke. Treatment with insulin infusions is proposed as a     neuroprotective strategy, and a clinical trial is ongoing to test this hypothesis. However,     the biological basis for insulin treatment has not been established, and there is uncertainty     about the duration of insulin infusion that may be required to limit damage.      Magnetic resonance spectroscopy (MRS) is a brain scanning technique that allows measurement     of brain lactic acid. When performed in conjunction with conventional MRI scanning, the     relationship of lactate accumulation to stroke expansion can be established. SELESTIAL is a     randomised, placebo-controlled trial of insulin infusions of 24 or 72 hours (h) duration in     acute stroke patients with hyperglycaemia, to establish whether insulin prevents lactate     accumulation over the initial 72h after stroke, how this relates to stroke evolution, and the     effect of treatment on stroke size and clinical outcomes at 1 week.   "
174528|NCT00124839|"     The purpose of this study is to investigate whether naltrexone reduces the intensity and     duration of flashbacks and dissociative states in patients with borderline personality     disorder.   "
174529|NCT00124852|"     The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled     trial with cognitive decline and early signs of depression as primary outcome measures.   "
174530|NCT00124865|"     This study is an open-labeled dose escalating trial in which a total of 32 subjects will     receive one of four intranasal rFla-MBP vaccine doses.   "
174531|NCT00124878|"     This randomized controlled trial conducted in Rakai District, Uganda, has enrolled 997 HIV     positive men and 500 men who declined to learn HIV results (regardless of HIV status). The     hypotheses are that male circumcision will be acceptable to and safe in both groups and will     reduce the rates of STD acquisition in both groups and of HIV acquisition in HIV-negative     men.      Enrollment was ended on Dec 12, 2006, following an interim Data Monitoring and Safety Board     (DSMB) review of a closed report. At that time the DSMB determined that futility with respect     to the female HIV outcome. There was an non-significantly higher rate of HIV acquisition in     women partners of HIV+ men in couples who had resumed sex prior to certified post-surgical     wound healing. The data indicated significant reductions (~50%) in GUD symptoms among     circumcised HIV+ men. The DSMB recommended: 1) that men and women should continue to be     followed in complete two year follow up on all, 2) that circumcision for remaining HIV+     intervention arm men and for control arm men who had completed their 2 year follow should     continue, contingent on a) revision of the study protocol to add additional post-surgical     visits to assess wound healing, b) protocol revision to further strengthen education for both     male and female partners on the need to postpone sex until certified wound healing, and c)     approval of the revised protocol by the IRBs in both the US and Uganda. 3) An additional     follow up visit for women be instituted at 18 months after enrollment. Protocol revision and     IRB approvals have been finalized in June, 2007.      The study has also enrolled and is following 3,700 women sexual partners of men enrolled in     this study and in a complementary National Institutes of Health (NIH) funded study (U1     AI51171 which is separately registered). The hypotheses are that male circumcision will be     acceptable to and safe in women partners, and will reduce the women's acquisition of HIV and     STDs such as herpes simplex virus-2 (HSV-2) and human papillomavirus (HPV).   "
174533|NCT00124904|"     Fecal incontinence affects 2% of adults in the United States. Biofeedback has been     recommended for the treatment of fecal incontinence because uncontrolled studies over the     past 25 years suggest that these treatments are as effective as medical or surgical     management and involve no risk. However, placebo-controlled trials are still lacking.      The aims of this study are: (1) to compare biofeedback to alternative therapies for which     patients have a similar expectation of benefit; (2) to identify which patients are most     likely to benefit; and (3) to assess the impact of treatment on quality of life.   "
174534|NCT00124917|"     BACKGROUND:      -This study represents a progression from findings in four previous NCI ROB protocols     (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to     develop techniques to obtain MR biological images and co-register tissue in prostate cancer     patients.      OBJECTIVES:      -The scientific objective of this protocol is to determine the maximum tolerated dose (MTD)     of external beam radiation to regions of interest within the prostate based acute toxicity.      Secondary objectives of this study are to relate patterns in gene and protein expression to     response and toxicity and to evaluate the frequency of late term toxicity.      ELIGIBILITY:      -Patients with prostate cancer without evidence of metastasis will be eligible for this     study.      DESIGN:        -  This phase I trial will use intensity modulated radiation therapy (IMRT) to deliver          escalating doses of external beam radiation to regions of histologically confirmed          prostate cancer. The study will be conducted using a standard 3-6 dose-escalation with          an initial 3 patients in each dose cohort and the potential expansion of the cohort to 6          patients.        -  Anatomic MRI and MR biological images, such as MRS, will be obtained Tissue will be          acquired from sites of interest, with biopsy locations precisely translated          (co-registered) to an MR image of reference. Tissue samples will be processed for cDNA          microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI.          A gold seed will be left at the biopsy site as a fiducial marker to direct future          radiation therapy. If necessary, additional fiducial markers will be placed for target          localization during treatment.        -  Once MR guided biopsies are obtained and fiducial markers placed, the patient will          undergo a standard CT simulation for radiation therapy treatment planning. The MR and CT          images will be fused. Areas of pathologically confirmed malignancy will undergo dose          escalation as described below. Areas of image abnormality that could not be biopsied or          were without definite pathologic evidence of malignancy will be given intermediate          doses. The remainder of the prostate gland will receive standard dose (7560 cGy.)        -  The trial will accrue 18 to 36 patients with an anticipated accrual period of 2 years.   "
174535|NCT00124930|"     The purpose of this study is to compare the efficacy and safety of Haldol (haloperidol) and     olanzapine in the control of chronic nausea with advanced cancer patients who have failed     first line antiemetic therapy.   "
174536|NCT00124943|"     The purpose of this study was to investigate the use of systemic intracoronary administration     of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis     following de novo stenting or following angioplasty for in-stent restenosis.   "
174537|NCT00124956|"     This protocol is designed to obtain detailed information on the impact of body composition on     the pharmacokinetic behavior of doxorubicin after a single intravenous dose in children 21     years of age or younger. There is no efficacy component. Approximately 9 children will be     enrolled at Children's Hospital Boston. The information gained from this study could be very     important in developing dosing strategies for doxorubicin in the obese patient population.   "
174592|NCT00125671|"     The purpose of this study is to evaluate whether the addition of warfarin (a blood-thinning     medication) to an antiplatelet therapy like aspirin is better than antiplatelet therapy alone     (i.e. usual treatment) for the prevention of leg surgery, heart attacks, stroke and death in     people with peripheral vascular disease.   "
174593|NCT00125684|"     Patients will participate in two arms of the trial, one in which morphine will be     administered transdermally, and, after a 3 day wash out period, one in which morphine will be     administered subcutaneously.   "
174538|NCT00124969|"     Patients with end-stage renal failure have a markedly higher mortality because of     cardiovascular events in comparison with the normal population. Disorders in the calcium     metabolism, such as calcification of the vessel walls, occur very frequently. There are     indications that calcium channel blockers are capable of lowering the cardiovascular     mortality in patients with end-stage renal failure.      It is intended to carry out a prospective, randomized, double-blind, placebo-controlled,     multicenter study in order to find out if the calcium channel blocker amlodipine is able to     reduce the mortality of patients with end-stage renal failure.      The investigation will be carried out after suitable explanation and written informed consent     in 356 patients aged between 18 and 90 years with end-stage renal failure and chronic     haemodialysis treatment. The patients will be randomized to either treatment with amlodipine     10 mg/day or placebo. The occurrence of events will be documented and evaluated prospectively     over a period of 30 months.   "
174539|NCT00124982|"     The purpose of this study is to summarize the safety and tolerability of abatacept during 6     months of combined treatment with one or more of the background non-biologic disease     modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects     with active RA. Secondary objectives assessed the clinical efficacy of combination treatment,     including disease activity, physical function, and quality of life outcomes.   "
174540|NCT00124995|"     Although widely used for the treatment of pediatric status asthmaticus, intravenous     terbutaline has potentially significant side effects; may not improve outcomes; and may     increase Intensive Care Unit (ICU) length of stay. This study is designed to test the     efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding     intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or     placebo will be titrated according to severity of illness as quantified by a validated     clinical asthma score. Differences in outcomes between the study groups, such as length of     stay, hospital costs, and lung function will be compared.   "
174541|NCT00125008|"     This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration     project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic     countries. The purpose of this study is to determine the effectiveness of the Vi vaccine     following a mass typhoid immunization campaign in an endemic area in Kolkata, India. The     cost-effectiveness of the Vi vaccination and the logistic feasibility of a mass typhoid     immunization campaign will also be evaluated.   "
174542|NCT00125021|"     This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774)     combined with capecitabine in treating patients with metastatic pancreatic cancer.   "
174543|NCT00125034|"     This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA +     oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for     epidermal growth factor receptor (EGFR)-expressing mCRC.   "
174694|NCT00127023|"     This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK)     Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy     children in their second year of life.   "
174544|NCT00125047|"     This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration     project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic     countries. The purpose of this study is to determine the effectiveness of the Vi vaccine     following a mass typhoid immunization campaign in an endemic area in Karachi, Pakistan. The     cost-effectiveness of Vi vaccination and the logistic feasibility of a mass typhoid     immunization campaign will also be evaluated.   "
174545|NCT00125060|"     This research is being done to investigate the ability of an experimental imaging method -     transesophageal magnetic resonance imaging (TEMRI), to detect the change in aortic     atherosclerotic plaque burden and morphology between patients on high dose cholesterol     lowering medications and patients on standard dose cholesterol lowering medications. This     study will use TEMRI to see how atherosclerosis (cholesterol build up) changes with     cholesterol lowering medications. This study will also investigate whether these     cholesterol-lowering medications will change levels of blood tests, called inflammatory     markers, in patients' blood. People with atherosclerosis may join this study. This study will     also store blood samples for future studies of cardiac diseases; no gene testing will be     done.   "
174546|NCT00125073|"     This study aims to assess the changes in physical characteristics, food intake, eating     behavior, vomiting, and dumping in 100 patients who undergo bariatric surgery. Patients are     put into one of two conditions; they will either receive standard postoperative care or     biweekly counseling sessions with a dietician that will help them with the postoperative     diet. Patients who receive dietary counseling are anticipated to experience greater weight     loss and report less consumption of sugar and fat as compared to patients who do not receive     dietary counseling. Moreover, patients who receive dietary counseling are predicted to report     less frequent nausea, vomiting, and gastric dumping, as compared to patients who do not     receive postoperative dietary counseling. This is predicted to result as a consequence of     increased dietary adherence evidenced by the former group.   "
174547|NCT00125086|"     This study will examine whether platelet gel positively affects wound healing. Platelet gel     will be used to treat punch biopsy wounds and the results will be compared to results from     wounds treated with a control treatment.   "
174548|NCT00125099|"     The purpose of this study is to evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be     safe in individuals who started antiretroviral therapy during acute HIV-1 infection. The     study will also test whether the vaccine can increase the immune system function in these     participants.   "
174549|NCT00125112|"     The purpose of this study is to determine if an internet-based intervention designed to     reduce binge eating and improve healthy weight regulation skills will result in reductions in     binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.   "
174550|NCT00125125|"     The purpose of the study is to find a good therapy for patients who need to be treated for     high cholesterol and who have difficulty tolerating other statins (such as pravastatin,     simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.   "
174551|NCT00125138|"     The purpose of this study is to evaluate the safety and efficacy of three target doses of     melperone compared to placebo in the treatment of psychosis associated with Parkinson's     disease. Subjects will be enrolled at approximately 20 investigational sites in the United     States (U.S.) and 15 Ex-US sites. The maximum study duration will be 10 weeks. Subjects will     have the option of continuing in an open-label extension study.   "
174552|NCT00125151|"     A multicentre study to investigate the pharmacokinetics, clinical efficacy and safety of     nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the     treatment of hereditary angioedema (HAE) will be performed. This study (KB2003.01) consists     of three parts: Part A - pharmacokinetics (phase II); Part B - treatment of attacks of     angioedema (phase III); and Part C - prophylactic use of C1 inhibitor (phase III). Parts B +     C will provide data on the efficacy of C1-esteraseremmer-N.      The changes within the manufacturing process of C1-esteraseremmer-N, compared to Cetor®     nanofiltration and omission of hepatitis B immunoglobulin, most likely will not affect     tolerability. The nanofiltration will provide more safety regarding viruses.      In Part B of the study, 15 attacks of hereditary angioedema will be treated with open-label     C1-esteraseremmer-N. Attack severity and duration will be monitored by the subjective     experience of the patient himself (which has been shown to be the most sensitive way of     monitoring attack severity) and compared with historical (and literature) data. If possible,     some attacks of acquired angioedema will also be included.   "
174553|NCT00125164|"     This study is intended to determine whether twice daily weight based dosing with recombinant     human insulin-like growth factor (rhIGF-1) will safely and effectively increase the growth of     prepubertal children with short stature associated with low IGF-1 levels but who produce     sufficient growth hormone (GH). Subjects will be randomized to either an observation arm or     to active treatment.   "
174554|NCT00125177|"     The IRIS project stands for Incontinence Research Intervention Study. The purpose of this     research project is to develop an effective behavioral therapy for urinary incontinence and     specifically to test Knack therapy, a self-help treatment. The Knack therapy involves     learning the skill of performing a pelvic muscle contraction simultaneously with an event     known to trigger leakage, in order to stop that leakage.   "
174555|NCT00125190|"     This study is intended to assess the effects of once daily dosing of recombinant human     insulin-like growth factor (rhIGF-1) in increasing height velocity.   "
174556|NCT00125203|"     The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients     who are having excessive drooling.      The primary goal of the study is to determine if the patient perceives a benefit from the     Myobloc in controlling excessive drooling.   "
174557|NCT00125216|"     The purpose of this study is to evaluate the effects of Response Elaboration Training (RET),     which is a speech/language therapy for aphasia. The study is designed to determine whether     verbal language production improves in terms of content and length of utterances as a result     of treatment.   "
174558|NCT00125229|"     This is a clinical study comparing the physiologic effects of two hypertonic solutions     (mannitol, hypertonic saline) with a particular emphasis on changes in cerebral blood flow in     patients with intracranial hypertension following serious traumatic brain injury (TBI).   "
174695|NCT00127036|"     The purpose of this study is to determine if the investigators can predict the sensitivity or     resistance of colon cancer to the two available first line chemotherapy agents.   "
174559|NCT00125242|"     The purpose of this investigation is to further develop and test a treatment for word-finding     problems in aphasia. The treatment is designed to strengthen meaning associations within     categories of words (e.g., animals, tools, fruits). The treatment is also designed to be used     as a search strategy in instances of word-finding difficulty. The study was devised to     evaluate the extent to which treatment increases the ability to recall trained, as well as     untrained, words.   "
174560|NCT00125255|"     The pain associated with medical procedures is often under-treated in children. Children     often undergo painful procedures with little or no anesthetic, even when effective therapy is     available. Reasons for not providing available therapy in children include concerns over     adverse side effects as well as the length of time necessary to provide adequate anesthesia.     Recent guidelines strongly advocate for the proactive treatment of pain in children,     including the pain associated with medical procedures.      S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine     and tetracaine. The purpose of this study is to evaluate whether S-Caine Peel is effective in     providing topical local dermal anesthesia prior to a vascular access procedure in children 5     through 17 years of age.   "
174561|NCT00125268|"     The purpose of this study is to determine if near infrared light therapy is effective in     decreasing pain in patients with painful peripheral neuropathy. The hypothesis of the study     was that the percentage of subjects with at least 40% improvement in visual analog scale     score for pain after 4 weeks of treatment is higher for Monochromatic Near-infrared     Photoenergy (MIRE) treatment than for sham treatment.   "
174562|NCT00125281|"     This study will examine the effect of S-adenosyl methionine (SAMe) on itching and fatigue in     patients with primary biliary cirrhosis, a disease of the small bile ducts in the liver.     Ursodiol, the only currently available treatment for biliary cirrhosis, does not cure the     disease, and many people continue to have symptoms or liver test abnormalities despite     treatment. SAMe is a naturally occurring substance found in most cells of the body. The     highest levels of the substance are produced by the liver, where it helps to rid the body of     toxins and breakdown products of metabolism. Studies in Europe suggest that SAMe may help to:     1) decrease the fatigue and itching that are common in persons with liver problems, and 2)     decrease levels of liver enzymes in the blood, suggesting that it may decrease the amount of     liver injury.      Patients 21 years of age or older with primary biliary cirrhosis who are taking ursodiol and     have symptoms of itching or fatigue may be eligible for this study. Candidates are screened     with a medical history, physical examination, review of medical records, routine blood tests,     and a symptoms rating scale.      Participants stop all medications for itching 4 weeks before starting the study, but continue     to take ursodiol during the 42-week trial. On entering the study, patients are assigned to     take either SAMe or placebo tablets twice a day for 12 weeks. While taking the medications,     they are followed in the clinic every 2 weeks for the first month and then every 4 weeks to     fill out symptoms questionnaires and have a short medical evaluation and blood tests. At the     end of 12 weeks, treatment is interrupted for a 2-week wash-out period, after which     patients begin a 12-week crossover treatment; that is, patients who were taking SAMe are     switched to placebo, and those who were taking placebo are switched to SAMe.      After completing the second 12-week treatment course, patients come to the clinic at 4, 8,     and 12 weeks to fill out symptoms questionnaires and have a medical evaluation and blood     tests. At the last visit, patients are told which type of tablet they received during the two     courses of treatment. SAMe is available without prescription in many forms as an     over-the-counter medication.   "
174563|NCT00125294|"     A dose titration protocol for sublingual methadone hydrochloride for the management of     cancer-related breakthrough pain to find the optimal dose.   "
174564|NCT00125307|"     The investigators study the efficacy and safety of tacrolimus in the treatment of membranous     nephritis secondary to systemic lupus erythematosus.   "
174565|NCT00125320|"     The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to     placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular     and/or coronary artery bypass graft surgery.   "
174566|NCT00125333|"     The purpose of this study is to determine whether this topical NF-kappaB Decoy candidate is     safe in persons with atopic dermatitis. Preliminary evidence of efficacy (whether it is     working) will also be evaluated.   "
174567|NCT00125346|"     Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients     with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can     cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an     approved antibiotic, which is inhaled directly into the lungs, and can be used to manage     these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder     formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The     purpose of this research study is to determine if TIP is safe and effective when compared to     placebo (a powder with no medicine) treatment.   "
174568|NCT00125359|"     The purpose of this study is to learn about the effects of two new anticancer drugs,     erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung     cancer.      Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of     non-small-cell lung cancer (NSCLC). Bexarotene is approved by the FDA for the treatment of     cutaneous T-cell lymphoma. This combination of drugs is experimental.   "
174569|NCT00125372|"     The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and     Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by     the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the     treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.   "
174570|NCT00125385|"     This study is designed to investigate whether GC1008, an antibody that neutralizes TGFb, is     safe in treating patients with idiopathic pulmonary fibrosis. The highest dose without     excessive side effects will be identified. Tests will determine how long GC1008 is in the     body and how it is excreted.   "
174571|NCT00125398|"     Patients who are in the intensive care unit after surgery and require mechanical breathing     support (intubation and ventilation) usually require sedation to avoid agitation and     excessive stress responses. Short-acting sedatives such as midazolam and propofol are the     drugs typically used for this. Propofol provides for fast sedation and fast recovery from     sedation. Midazolam is slower to sedation and slower for recovery, but may provide some     advantages over propofol, such as a lower incidence of hypotension (low blood pressure). This     study will look at propofol compared to a product with fast sedation and recovery like that     of propofol but with less of a chance for hypotension like with midazolam. Patients will be     treated with the product for up to 8 hours and then will be monitored for 8 hours following     treatment.   "
174584|NCT00125567|"     The purpose of this study is to demonstrate in patients with Parkinson's disease that, when     compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to     the time an increase in antiparkinsonian medication is required due to inadequately     controlled parkinsonian symptoms.   "
174572|NCT00125411|"     This is a single center, open-label, non-randomized, Phase I dose finding study of the     investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in     patients with advanced solid tumors for whom curative therapy is not available. Please refer     to the Eligibility Criteria below for key inclusion and exclusion criteria.      PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the     combination of satraplatin and docetaxel when given to patients with advanced solid tumors.      WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member     of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically     proven to be one of the most effective classes of anticancer therapies. Unlike the currently     marketed platinum-based drugs, satraplatin can be given orally.   "
174573|NCT00125424|"     Very often, patients receive sedative medication before a diagnostic, therapeutic, or     surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is     called procedural sedation. During procedural (mild to moderate) sedation, a patient is first     given a pain-relief medication (analgesic) and then a medication to help him/her relax and     keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it     releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol     disodium) is made as a slow release version of propofol, allowing for fast sedation and     possibly faster recovery and discharge.      This study is intended to compare several different doses of AQUAVAN in patients having a     colonoscopy in order to find the right dose that will get patients to a level of mild to     moderate (procedural) sedation.   "
174574|NCT00125437|"     The purpose of this study is to determine whether a larger dose of the aldosterone antagonist     spironolactone combined with a lower dose of an ACE inhibitor is more effective in reverse     left ventricular remodeling in severe congestive heart failure in patients with nonischemic     cardiomyopathy.   "
174575|NCT00125450|"     The purpose of this study is to determine whether chest physiotherapy with forced expiratory     technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24     months of age.   "
174576|NCT00125463|"     The purpose of this study is to compare an angiotensin II receptor antagonist (candesartan     cilexetil– Blopress®) and a calcium channel blocker (amlodipine besilate– Norvasc®/Amlodin®)     in terms of the incidence of cardiovascular events among high-risk hypertensive patients.   "
174577|NCT00125476|"     This study is a prospective follow-up study to the Dose-Response to Exercise in Women (DREW)     study. In DREW, 450 overweight, sedentary postmenopausal women were randomly assigned to     either a non-exercise control group or to 1 of 3 weekly physical activity groups. The DREW     study is evaluating the dose-response of exercise training in regard to changes in multiple     cardiac risk factors. This study will measure diastolic heart function in a subset of the     DREW population in order to examine the relationship between dose response, changes in     physical activity, and diastolic function. Diastolic heart function will be assessed using     both traditional and novel echocardiographic measures.   "
174578|NCT00125489|"     The purpose of this research study is to find out how well chloroquine works as a drug to     treat malaria in children, compared to the standard malaria treatment in Malawi. In     preparation for a longer study of the malaria treatment medication chloroquine alone and in     combination with other drugs, a shorter pre-study will be done to compare the anti-malarial     effectiveness of chloroquine versus sulfadoxine-pyrimethamine (SP), the standard treatment in     Malawi. Two hundred ten children, ages 6 months to 12 years, around Blantyre, Malawi, will be     given standard dosing of either chloroquine or SP when they come to the Ndirande Health     Centre with signs or symptoms consistent with malaria. The first 30 participants in each     treatment group will remain under continuous observation at the health center so that the     researchers can monitor their response to the medication until the infection goes away. The     participants will be followed for 28 days to see if the the treatment works or fails.   "
174579|NCT00125502|"     The purpose of this study is to determine if a new cytomegalovirus (CMV) vaccine (CMV     gB/MF59) can safely prevent mothers from catching CMV infection between pregnancies. This     study includes 464 women, ages 14-40 years, who delivered a newborn infant within 12 months     prior to the study. Participants must live within the Birmingham metropolitan area or the     Tuscaloosa county area and they cannot have had CMV infection previously. CMV vaccine or     placebo (substance containing no medication) will be given at 3 study visits. Participants     fill out diary cards for 7 days after each vaccination. Blood samples will be collected.     Urine samples will be collected several times and pregnancy tests will be performed.     Participants who tested positive for CMV will have urine, vaginal swab, and saliva specimens     collected. Each participant will be followed for 3 years after the third dose of vaccine.     Infants born to participants in the study will be checked for CMV infection.   "
174580|NCT00125515|"     The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor     antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified     heroin-dependent individuals.   "
174581|NCT00125528|"     Pre-clinical studies in rats suggest that D-cycloserine (DCS) is effective in the management     of chronic neuropathic pain. This pilot study will attempt to determine the effect of     D-cycloserine in the treatment of chronic low back pain. Other aims of this study are to     determine the safety of D-cycloserine in the treatment of chronic low back pain and to     determine which pain measurement scales are best at measuring the efficacy of treatment.   "
174582|NCT00125541|"     A multicentre study to investigate the pharmacokinetics, clinical efficacy and safety of     nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the     treatment of hereditary angioedema (HAE) will be performed. This study (KB2003.01) consists     of three parts: Part A - pharmacokinetics (phase II); Part B - treatment of attacks of     angioedema (phase III); and Part C - prophylactic use of C1 inhibitor (phase III). Parts B +     C will provide data on the efficacy of C1-esteraseremmer-N.      The changes within the manufacturing process of C1-esteraseremmer-N, compared to Cetor®     nanofiltration and omission of hepatitis B immunoglobulin, most likely will not affect     tolerability. The nanofiltration will provide more safety regarding viruses.      In part C of the study, a number of HAE patients will be treated prophylactically with     open-label C1-esteraseremmer-N for a period of 16 weeks. The number of attacks occurring will     be compared with historical data. If possible, also some patients treated prophylactically     with C1 inhibitor for acquired angioedema will be included.   "
174585|NCT00125580|"     Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even     among very young children. A recent report from the National Health and Nutrition Examination     Survey (NHANES) revealed that from 1999 to 2002, 10.3% of children ages 2 to 5 were     overweight, an increase from 7% in 1994. Epidemiologic evidence is now emerging that suggests     obesity in childhood and adulthood may often originate from accelerated weight gain during     infancy. Further data are accumulating that link short sleep duration with obesity during     childhood and later life. Prospective data are lacking that demonstrate whether the     accelerated weight gain during infancy can be prevented and whether interventions to improve     sleep early in life can prevent childhood obesity.      Key Objectives:      The key objectives are:        -  To adapt a procedure aimed at prolonging sleep duration during infancy that is effective          in experimental settings to the clinical setting of primary care; and        -  To evaluate, in the primary care setting, the effect of a simple training procedure on          overnight sleep duration and rate of weight gain during the first four months of life.   "
174586|NCT00125593|"     The chief aim of SHARP was to determine whether lowering blood LDL cholesterol with     simvastatin (20mg) plus ezetimibe (10mg) daily could safely reduce the risk of coronary heart     disease, non-hemorrhagic stroke and the need for revascularization procedures in patients     with chronic kidney disease (CKD). It also aimed to assess whether lowering LDL cholesterol     reduced the rate of loss of renal function in people with CKD who had not commenced dialysis     treatment.   "
174587|NCT00125606|"     For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell     transplantation (HSCT) is one of the most potent treatment options currently available. In     order to overcome the high risk of fatal treatment-related complications, reduced intensity     and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored     in various hematological malignancies including AML. At least for allogeneic HSCT in AML, the     optimal dose-intensity of preparative regimens for disease control at an acceptable rate of     treatment-related lethal complications has not been determined. The investigators, therefore,     evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML     patients considered ineligible for conventional conditioning in a phase 2 trial (data     published in BLOOD by Stelljes et al., 2005). The results suggest that with 8 Gy     TBI/fludarabine, conditioning related and unrelated donor transplants can be performed in AML     patients in first or second complete remission (CR) with a remarkably low 2-year non relapse     mortality (NRM) and satisfactory disease control. Based on these data a randomized phase 3     trial for patients with AML in CR≥2 is currently being conducted by the Cooperative German     Transplant Study Group comparing TBI 8 Gy/fludarabine to conventionally dosed conditioning     with TBI 12 Gy/cyclophosphamide.   "
174588|NCT00125619|"     The overriding goal of this proposal is to identify the critical physiological and     biomechanical effects of BWSTT for promoting improved locomotor function in persons with     post-stroke hemiparesis.   "
174589|NCT00125632|"     The purpose of this study is to measure the effectiveness of a newly-designed oculomotor     training program for patients with age-related macular degeneration.   "
174590|NCT00125645|"     The purpose of this study is to compare changes in global left ventricular (LV) function     after 3 months of treatment with irbesartan compared with usual care in patients with acute     myocardial infarction, a wall motion score >1.3 (EF>0.40) and signs of diastolic dysfunction.     The hypothesis is that an angiotensin 2-receptor inhibitor will improve global left     ventricular function.   "
174594|NCT00125697|"     Malignant glioma is the most common primary brain tumor in adults. Despite aggressive     therapy, less than 40% of these patients are expected to live beyond 5 years. The radiologic     imaging of these tumors relies on computed tomography (CT) and magnetic resonance imaging     (MRI) - these studies provide good anatomical information about the size and location of the     tumor, but are unable to evaluate whether the tumor is still viable or contains metabolic     activity, after surgery and, in particular, radiotherapy (RT). This complicates accurate     understanding of the status of the tumor during a patient's follow-up. This study proposes to     add magnetic resonance spectroscopy, a non-invasive imaging method which can monitor     metabolic changes in the tumor, to regular imaging. Understanding the changes that occur in a     tumor over the course of radiotherapy could help predict how well a treatment might work, and     could also be useful in distinguishing a return of the tumor in an area of radiation damage     before it would be obvious on regular imaging.   "
174595|NCT00125710|"     The treatment for patients with malignant brain tumors is disappointing. The disease is     incurable and virtually all patients die from their disease. Despite the devastating nature     of this illness which affects all age groups, its cause remains unexplained. Family     identification with careful clinical and molecular study have led to the discovery of the     genes that cause a number of other devastating diseases like retinoblastoma, cystic fibrosis,     and Huntington's chorea. The investigators propose to study the genetic changes in patients     with familial glioma as a first step in identifying the gene(s) that cause these tumors.   "
174596|NCT00125723|"     The purpose of the study is to assess the impact of first and subsequent cycle pegfilgrastim     on neutropenia events (such as hospitalizations, dose reductions and delays) in patients     receiving myelosuppressive chemotherapy.   "
174597|NCT00125736|"     The purpose of this study is to investigate the efficacy and safety of combination use of     E0671 and Rabeprazole Sodium in patients with gastric ulcer.   "
174598|NCT00125749|"     The purpose of this study is to test a novel dendritic cell (DC) vaccine in patients with     Stage IV melanoma.   "
174599|NCT00125762|"     This study will examine the effectiveness of the FibroScan device in differentiating fibrosis     in patients with hepatitis B and C. The FibroScan measures liver stiffness and will be     correlated to the liver biopsy to see if it can diagnose the stage of liver disease. Patients     who are scheduled to have a liver biopsy will also have a fibroscan and the stiffness will be     correlated with the biopsy stage.   "
174613|NCT00125944|"     The objective is to assess the safety of bivalent vaccine of two new 6:2 influenza virus     reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist)     containing them.   "
174696|NCT00127049|"     This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide     (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted     favorable prognosis.   "
174600|NCT00125775|"     Hepatitis B virus causes inflammation of the liver which is detrimental to the end-stage     renal disease patients on dialysis. Hepatitis B vaccine is recommended for this high-risk     population although the vaccine protection remains suboptimal and does not last long.      The purpose of this study is to determine the best vaccination strategy over a 6-month period     using recombinant hepatitis B vaccine (Engerix-B) in peritoneal dialysis patients. Current     data show that the traditional Engerix-B vaccine dose (40 micrograms) does not always lead to     protective and long-lasting hepatitis B surface antibody. The investigators, therefore,     decided to compare the usual 40-micrograms with an 80-microgram dose strategy of vaccine     protection.   "
174601|NCT00125788|"     The purpose of this research is to evaluate the effects of L-glutamine as a therapy for     sickle cell anemia and sickle ß0-thalassemia. as evaluated by the number of occurrences of     sickle cell crises.   "
174602|NCT00125801|"     The purpose of this study is to see whether injection of hydromorphone through a subcutaneous     injection device is more effective in treating breakthrough cancer pain than oral morphine.   "
174603|NCT00125814|"     The purpose of this study is to determine whether the adjunctional of interferon alfa to     structured treatment interruptions correlated with a long time off treatment in HIV-1     infection.   "
174604|NCT00125827|"     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia     (ALL) who have had at least 2 prior treatment regimens.      This is a research study of clofarabine that will be given to patients (orally) with advanced     cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer     effective or no reliable effective treatment is available.      The purpose of this study is to find the answers to the following research questions:        1. What is the largest dose of oral clofarabine that can be safely given daily for 5 days          followed by 23 days of rest and repeated every 28 days?        2. What are the side effects of clofarabine when given on this schedule?        3. How much oral clofarabine is in the blood at specific times after administration and how          does the body get rid of the drug?        4. Will oral clofarabine help treat solid tumor cancer?   "
174605|NCT00125840|"     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia     (ALL) who have had at least 2 prior treatment regimens.      This research study of clofarabine will be used for advanced cancer in persons in which drugs     are no longer effective or no reliable effective treatment is available. The purpose of this     study is to find the answers to the following research questions:        1. What is the largest dose of clofarabine that can be safely administered as an IV          infusion (over at least 2 hours) once a week for 3 weeks (days 1, 8 and 15) followed by          1 week of rest and repeated every 28 days?        2. What are the side effects of clofarabine when given on this schedule?        3. How much clofarabine is in the blood at specific times after administration and how does          the body get rid of the drug? Once the MTD/RP2D is established, patients will be          enrolled at the MTD/RP2D regardless of the PK data with cardiac assessments done every          other cycle.        4. Will clofarabine help treat a specific cancer?   "
174606|NCT00125853|"     The purpose of this study is to conduct a randomised trial to compare the insulin     sensitivity, 24 hour blood pressure profile, and tolerability of nebivolol plus a     thiazide-like diuretic versus atenolol plus a thiazide-like diuretic.   "
174607|NCT00125866|"     The purpose of this study is to compare the effects on blood pressure of a daily intake of a     flavonoid-rich cocoa drink with that of the same drink from which the flavonoids have been     largely extracted.   "
174733|NCT00127127|"     The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the     maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral     suberoylanilide hydroxamic acid in patients with solid tumors.   "
174608|NCT00125879|"     Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the     body's cells to break down glycogen (a stored form of sugar) within specialized structures     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates     and is stored in various tissues, especially heart and skeletal muscle, which prevents their     normal function. The overall objective of this study is to evaluate the long-term safety and     efficacy of Myozyme treatment in patients with infantile-onset Pompe disease.   "
174609|NCT00125892|"     This study is designed to evaluate duloxetine for the treatment of fibromyalgia syndrome     patients.   "
174610|NCT00125905|"     Primary care centers can play a very important role in helping people to stop smoking. There     is a large body of research on the effectiveness of specific interventions especially     addressed to people who want to stop smoking. In addition to that, there are no studies with     a large sample of individuals included that tested the complete range of interventions     recommended nowadays for helping people in the different smoking cessation stages of change     and with different degrees of physical and psychological dependence, especially including     motivational interviewing in those not interested in cessation in the very next weeks. This     study will test a complex intervention that at first classifies smokers in stages and after     that treats every smoker according to what stage he/she is in at the moment, his/her degree     of dependence and his/her own characteristics.   "
174611|NCT00125918|"     The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the     treatment of pulmonary arterial hypertension.   "
174612|NCT00125931|"     The opiate neurotransmitter system is thought to be involved in many abnormal mood states.     Some researchers have suggested that changes in this system may trigger the switch to/from     manic and depressive states in bipolar disorder. One problem with most of the currently     available opiate medications is that they can produce addiction/dependence. A particular kind     of opiate medication known as kappa-opiates may be able to produce changes in this system     with much less risk of addiction. This study looks at Talwin (a combination of pentazocine     and naloxone), a medication which affects the kappa and mu opiate systems. The study will     examine whether two doses of Talwin affect manic symptoms in people who have been admitted to     the hospital. This study will give more information about the involvement of the opiate     system in bipolar disorder, and give important information for use in developing new     treatments.   "
174614|NCT00125957|"     Many people with depression are treated with a serotonin-specific reuptake inhibitor     anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not     feel completely 'well'. Often, individuals continue to complain of cognitive problems such as     lack of attention, diminished motivation, and impaired problem-solving. This study looks at     whether residual and cognitive symptoms of depression in individuals are affected by the     addition of Wellbutrin (bupropion).   "
174615|NCT00125970|"     The purpose of the study is to determine the safety of and immune response to a DNA HIV     vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.   "
174616|NCT00125983|"     The purpose of this study is to examine the drug interactions between a protease inhibitor     (PI)-based regimen including lopinavir/ritonavir (LPV/r) and two forms of contraceptive     medications in HIV infected women.   "
174617|NCT00125996|"     This is a two-center, randomised, single-blind (physician), prospective, controlled study to     assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose     supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure     (CHF).      The hypotheses are:        -  Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose          improves exercise capacity as measured by peak VO2.        -  IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.   "
174618|NCT00126009|"     The primary objective is:        -  To compare the efficacy of the association valproate-amisulpride (400 to 800 mg/day) to          the association valproate-haloperidol (5 to 15 mg/day) in bipolar I patients suffering          from a manic episode according to DSM IV TR (American Psychiatric Association [APA]          2000) and treated for a 3-month period.      The secondary objectives are:        -  To evaluate the clinical and biological safety of the association valproate-amisulpride          to the association valproate-haloperidol;        -  To assess the patient status 3 weeks and 3 months after inclusion; and        -  To assess patient satisfaction at 3 months.   "
174619|NCT00126022|"     The purpose of this study is to demonstrate the ability of tedisamil to convert atrial     fibrillation or flutter into normal sinus rhythm (NSR) in female patients.   "
174620|NCT00126035|"     The purpose of the study was to assess the efficacy of Migraid in terms of preventing     headaches in patients with migraine with typical aura. The secondary objectives were to     assess whether Migraid is able to achieve pain relief and/or relief of migraine associated     symptoms and to evaluate the safety and tolerability of the study treatment.   "
174637|NCT00126256|"     The standard treatment of metastatic colorectal cancer is based on systemic chemotherapy.     Several effective drugs are currently available and can be administered either sequentially     or in combination. Most patients receive 2 or 3 lines of chemotherapy. The aim of this     randomized trial is to evaluate the potential benefit of a bitherapy with 5-fluorouracil     (5-FU) and oxaliplatin as first line chemotherapy compared with a sequential chemotherapy     with 5-FU alone as first line chemotherapy followed by the combination of 5-FU with     oxaliplatin in case of progressive disease, in terms of progression-free survival and overall     survival in patients with advanced colorectal cancer.   "
174638|NCT00126269|"     This is a randomized phase III trial comparing cisplatin with or without gemcitabine in     patients with carcinoma of unknown primary and a predicted favorable prognosis.      The purpose of this trial is to compare the overall survival rates of patients with carcinoma     of unknown primary (CUP) and a predicted favorable prognosis according to the French     classification treated with cisplatin with or without gemcitabine.   "
174734|NCT00127140|"     The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the     maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral     vorinostat in patients with malignant lymphoma.   "
174621|NCT00126048|"     Statins are the most common type of cholesterol-lowering drugs used in clinical practice.     Recent research suggests that they may also have anti-inflammatory properties, in particular     by inhibition of an important inflammatory cell called a T lymphocyte. Asthma is     characterised by chronic inflammation in the airways, which is thought to be regulated by the     activity of T lymphocytes. The investigators have found the anti-inflammatory activity of a     statin drug in an experimental model of allergic asthma and they have recently shown the     beneficial effects of a statin, atorvastatin, in patients with rheumatoid arthritis. These     findings demonstrate the therapeutic potential of statin-sensitive pathways in allergic     airways disease. The investigators plan to perform a proof of concept study to determine     the effectiveness of statin therapy in asthma. This randomised controlled trial will test the     hypothesis that statins improve asthma control of patients with chronic asthma. The study     will be a 22-week randomised controlled trial comparing the effect on asthma control of oral     atorvastatin with that of a matched placebo. Each treatment will be administered for 8 weeks     separated by a 6-week washout period. A total of 52 allergic asthmatic patients will be     recruited to ensure that 44 patients complete the study. The investigators will examine the     effect of statin therapy on lung function, symptom scores, exacerbation rates, as well as on     the measurement of airway inflammation in sputum and in the blood. This study will determine     the benefit of atorvastatin as an add-on therapy in asthma and establish if statins might     have a role in asthma management.   "
174622|NCT00126061|"     The purpose of this study is to demonstrate the ability of tedisamil to convert atrial     fibrillation or flutter into normal sinus rhythm (NSR) in male patients.   "
174623|NCT00126074|"     The purpose of this study is to demonstrate the ability of tedisamil to convert atrial     fibrillation or flutter into normal sinus rhythm (NSR) in female patients.   "
174624|NCT00126087|"     The investigators plan to improve the learning of motor skills by pharmacological means     (dopamine), and by noninvasive brain stimulation. They will study both healthy subjects and     chronic stroke patients. In addition, they want to study the mechanisms of enhanced learning,     on the molecular and the systems level.   "
174625|NCT00126100|"     The purpose of this study is to determine whether stem cell mobilization by granulocyte     colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after     successful mechanical reperfusion reduces infarct size.   "
174645|NCT00126360|"     This is a randomized study comparing the use of Anastrozole before and continuing during     radiotherapy for breast cancer compared to the use of anastrozole after irradiation.   "
174626|NCT00126113|"     The purpose of the study is to determine whether a new test of ability to understand speech     in noise and an associated counseling program can improve hearing aid satisfaction.     Participants complete routine hearing tests, some hearing-related questionnaires and the new     speech test. One group of participants receives the new form of counseling, the second group     does not. Hearing aid satisfaction following 10 weeks hearing aid use is compared across the     groups.   "
174627|NCT00126126|"     The purpose of this study is to determine if an evidence based exercise intervention improves     the functional mobility of diabetic amputees (single lower leg amputation) who have already     completed standard rehabilitation and prosthetic training.   "
174628|NCT00126139|"     The purpose of the present prospective, randomized, double-blind, double dummy controlled     multicenter pilot study is to investigate whether abciximab, compared with aspirin, is able     to reduce the rate of recurrent ischemic strokes before and during carotid endarterectomy     [CEA] (primary endpoints); and the degree of carotid stenosis, number of microembolic signal     (MES) counts, number of ischemic infarcts at diffusion weighted imaging (DWI) and amount of     intraluminal thrombus at pathological examination (secondary endpoints) in patients with     ischemic stroke due to a >50% carotid stenosis who will undergo CEA.   "
174629|NCT00126152|"     The purpose of this study is to evaluate the effectiveness of a best practice model for     senior falls prevention when implemented in a community setting.   "
174630|NCT00126165|"     This study is aimed at providing further clinical evidence to support or refute the current     understanding of biological sensitivity of prostate cancer to fractionated radiotherapy.     Determining the morbidity and cancer control provided by a 4-week course of treatment will     greatly influence future radiotherapy services for patients with localized prostate cancer.   "
174631|NCT00126178|"     This is an international, open label, randomized phase 3 trial in which patients with     surgically removable kidney cancer will be randomly selected post-operatively to receive     adjuvant treatment with autologous HSPPC-96 or no adjuvant treatment. All patients will     undergo complete surgical removal of their tumors.   "
174632|NCT00126191|"     The purpose of this study is to learn more about how well a chemotherapy regime including     rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma.   "
174633|NCT00126204|"     The durability of endovascular aneurysm repair (EVAR) has been limited by development of     endoleaks which may be secondary to progressive aortic degeneration by matrix     metalloproteases (MMP). Doxycycline is a known inhibitor of the MMP family of enzymes in     aneurysms. The investigators propose a randomized, controlled trial of adjuvant doxycycline     therapy with EVAR to determine its effects on re-intervention, aneurysm shrinkage and serum     markers of aneurysmal degeneration.   "
174634|NCT00126217|"     BCG has marked immune stimulatory effects in both animal and human studies and observational     studies suggest that BCG is associated with a non-specific reduction in mortality in areas     with high infant and child mortality. The specific objective of the study is to examine the     effect of revaccination for purified protein derivative of tuberculin (PPD) reaction, scar     size, morbidity and mortality in a randomised prospective study of revaccination versus no     revaccination among children 19 months of age in Guinea-Bissau. The hypothesis is that     revaccination with BCG reduces childhood mortality after 19 months of age by 30%.   "
174635|NCT00126230|"     This is a prospective phase II trial of docetaxel-samarium in patients with     hormone-refractory advanced prostate cancer who achieve a response or a stabilization to     docetaxel-estramustine.   "
174636|NCT00126243|"     Most treatment procedures in AIDS-related lymphomas disclose a relatively poor outcome for     patients with low response rates, high number of relapses and AIDS events. The addition of     rituximab to the standard regimen - CHOP could improve the outcome of these patients. The aim     of the trial is to evaluate the safety and efficacy of rituximab when added to the CHOP     regimen in patients with newly diagnosed AIDS-related non-Hodgkin lymphoma.   "
174639|NCT00126282|"     This study examines the efficacy of the medication D-Cycloserine in the reduction of     obsessions and compulsions in individuals with obsessive-compulsive disorder (OCD). All study     participants will receive Exposure and Response Prevention, a common form of behavior therapy     for individuals with OCD. Half (50%) of the participants will be randomly assigned to the     placebo condition and the other half (50%) will be randomly assigned to receive     D-Cycloserine. Because all participants will receive 10 sessions of behavior therapy, all     participants are expected to improve from this treatment.   "
174640|NCT00126295|"     The primary aim of the randomised controlled trial was to evaluate the effectiveness of a     tailored written education package (“What you need to know about stroke) on the outcomes of:        -  Knowledge about stroke, self-efficacy, anxiety, depression, perceived health status,          satisfaction with the content and presentation of the information received, and desire          for additional information for patients following stroke and        -  Knowledge about stroke, self-efficacy, anxiety, depression, satisfaction with the          content and presentation of the information received, and desire for additional          information for their carers.      A secondary aim was to evaluate the effect of written information on the outcomes of     knowledge about stroke, self-efficacy, anxiety, depression, and perceived health status of     patients following stroke and on knowledge about stroke, self-efficacy, anxiety, and     depression of their carers.   "
174641|NCT00126308|"     This is a multi-centre, open-label, 96 week study to evaluate the safety, tolerability and     extent and duration of improvement in HIV-1 infected subjects with antiretroviral induced     facial lipoatrophy, randomised in a 1:1 ratio to receive immediate or deferred deep     subcutaneous injections of poly-L-lactic acid (PLA). Subjects will receive 4 treatments of     PLA approximately every 2nd week, either at trial entry or following a delay period of 24     weeks.   "
174642|NCT00126321|"     The purpose of this study is to evaluate the safety and the efficacy of cladribine, high-dose     cytarabine and idarubicin in the treatment of patients with relapsed acute myeloid leukemia.   "
174643|NCT00126334|"     The purpose of this trial is to determine whether a conservative or a liberal blood     transfusion strategy is better for patients with a heart attack and a low blood count.   "
174644|NCT00126347|"     The purpose of this study is to determine whether reducing the increase in plasma     homocysteine concentrations following an oral methionine load affects vascular function in     healthy volunteers, irrespective of the homocysteine-lowering agent.   "
174647|NCT00126386|"     Treatment in the home and hospice of long-term care facilities, particularly for     non-ambulatory patients, could provide significant advantages for patients and for the     region. The Calgary Health Region has a unique resource in the home parenteral therapy     program (HPTP). With the assistance of HPTP, patients requiring bisphosphonate treatment for     the management of tumor-induced hypercalcemia (TIH) or malignant bone pain (MBP) could be     treated in the community (ie at home). However, the resources required and the costs     associated with community-based (homes, hospices, long-term care facilities) treatment of TIH     and MBP need to be identified and evaluated so as to guide future regional decision making.   "
174648|NCT00126399|"     The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline     controlled-release capsules administered once daily for the treatment of rosacea compared     with a placebo.   "
174649|NCT00126412|"     The study is designed to study the effectiveness of 123I-mIBG as a diagnostic imaging agent     in evaluating patients with known or suspected neuroblastoma or phaeochromocytoma.   "
174650|NCT00126425|"     The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to     predict cardiac outcomes in subjects with heart failure and in comparison to subjects without     cardiovascular disease.   "
174651|NCT00126438|"     The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to     predict cardiac outcome in subjects with heart failure and in comparison to subjects without     cardiovascular disease.   "
174652|NCT00126451|"     This is an investigational study to determine the response rate of relapsed/refractory     breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid     (SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response     evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and     tolerability of oral suberoylanilide hydroxamic acid.   "
174653|NCT00126464|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor     cells. Giving fulvestrant or tamoxifen before surgery may be an effective treatment for     breast cancer.      PURPOSE: This randomized clinical trial is studying how well giving fulvestrant or tamoxifen     works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in     situ of the breast.   "
174654|NCT00126477|"     RATIONALE: Studying quality of life in cancer survivors may help determine the long-term     effects of hematologic cancer and may help improve the quality of life for future cancer     survivors.      PURPOSE: This clinical trial is studying the quality of life of adult cancer survivors who     have undergone a previous bone marrow or peripheral stem cell transplant for a childhood     hematologic cancer.   "
174655|NCT00126490|"     This phase II trial is studying how well giving bevacizumab together with interleukin-2 works     in treating patients with metastatic kidney cancer. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood     flow to the tumor. Interleukin-2 may stimulate the white blood cells to kill tumor cells.     Giving bevacizumab together with interleukin-2 may kill more tumor cells.   "
174735|NCT00127153|"     The purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an     investigational pneumococcal vaccine in healthy adults.   "
174738|NCT00127192|"     The purpose of this trial is to determine the efficacy and safety of an investigational drug     in patients with type 2 diabetes mellitus.   "
174656|NCT00126503|"     This phase I/II trial studies the side effects and best dose of sorafenib tosylate and     bevacizumab and to see how well they work in treating patients with advanced kidney cancer.     Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth by     targeting certain cells. Bevacizumab and sorafenib tosylate may also stop the growth of tumor     cells by blocking blood flow to the tumor. Giving sorafenib tosylate together with     bevacizumab may kill more tumor cells.   "
174657|NCT00126516|"     The purpose of this study is to elucidate whether or not angiotensin II receptor blockers     (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on     development or progression of silent brain infarction and cognitive decline in Japanese     patients with essential hypertension in the elderly.   "
174658|NCT00126542|"     This phase II trial is studying how well giving bevacizumab together with erlotinib works in     treating patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary     peritoneal cavity cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may     also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     bevacizumab together with erlotinib may kill more tumor cells.   "
174659|NCT00126555|"     The goal of this clinical research study is to learn if giving Iressa (Gefitinib or ZD1839)     with surgery and/or radiation will help to control squamous cell carcinoma of the skin. The     safety of this treatment will also be studied   "
174660|NCT00126568|"     This phase II trial is studying how well sorafenib works in treating patients with advanced     anaplastic thyroid cancer. Sorafenib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
174661|NCT00126581|"     This randomized phase II trial studies how well erlotinib hydrochloride with or without     carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung     cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib     hydrochloride together with carboplatin and paclitaxel may kill more tumor cells.   "
174849|NCT00130338|"     The goal of this research study is to evaluate, in the open-label extension phase, the     effectiveness, tolerability and safety of rivastigmine capsules in males and females between     the ages of 50 and 85 years old with probable vascular dementia.   "
174662|NCT00126594|"     This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well     they work compared to sorafenib alone in treating patients with metastatic kidney cancer.     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and     interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with     interferon alfa-2b may kill more tumor cells.   "
174663|NCT00126607|"     This phase II trial is studying how well trastuzumab works in treating patients with     metastatic or recurrent salivary gland cancer. Monoclonal antibodies, such as trastuzumab,     can block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them   "
174664|NCT00126620|"     RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking blood flow     to the tumor and by blocking some of the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib and     erlotinib in treating patients with metastatic or unresectable solid tumors.   "
174665|NCT00126633|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Giving gemcitabine and cisplatin     together with bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together     with bevacizumab works in treating patients with metastatic pancreatic cancer.   "
174666|NCT00126646|"     RATIONALE: BL22 immunotoxin can find tumor cells and kill them without harming normal cells.      PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in     treating patients with refractory B-cell chronic lymphocytic leukemia, prolymphocytic     leukemia, or non-Hodgkin's lymphoma.   "
174667|NCT00126659|"     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. Giving sorafenib before and after surgery may     be an effective treatment for kidney cancer. This phase II trial is studying how well     sorafenib works in treating patients who are undergoing surgery for metastatic kidney cancer.   "
174668|NCT00126672|"     RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well sirolimus works in treating patients with     angiomyolipoma of the kidney.   "
174669|NCT00126685|"     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body     build an effective immune response to kill tumor cells.      PURPOSE: This phase I/II trial is studying the side effects of vaccine therapy and to see how     well it works in treating patients with stage IV melanoma.   "
174670|NCT00126698|"     Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of     all). The purpose of this study is to determine whether antibiotic prophylaxis for urinary     catheter removal is useful at preventing catheter-associated urinary-tract infection.   "
174685|NCT00126906|"     In Malawi, the standard of care to prevent malaria during pregnancy at the time of the study     was a two dose sulfadoxine-pyrimethamine intermittent protective treatment (SP IPT) regimen     administered in the second and third trimester of pregnancy. In this investigation, this two     dose strategy was compared to a monthly SP regimen. The objective for the study was to     determine the efficacy of the different regimens for HIV positive and HIV negative women in     the prevention of placental malaria.   "
174671|NCT00126724|"     The 13G01 clinical trial is a Phase I/II dose escalation study designed to be conducted in     adults with inflammatory arthritis who have persistent moderate or severe swelling in one or     more joints, without a disease severe enough to warrant a change in regimen for the next     three months.      The study will permit subjects who are concurrently on anti-tumor necrosis factor (TNF)-alpha     antagonists. For subjects on disease modifying antirheumatic drugs (DMARDs), a stable regimen     for inflammatory arthritis for the previous three months, with no changes in doses in the     four weeks prior to screening will be required.      The primary objectives are:        1. to evaluate the safety of intra-articular administration of tgAAC94 in subjects          currently taking TNF-alpha antagonists, and        2. to evaluate the safety of repeat intra-articular administration of tgAAC94 (gene therapy          vector).   "
174672|NCT00126737|"     The purpose of this study is to determine whether a home-based exercise and weight control     program applied to elderly overweight individuals with painful osteoarthritis of the knee,     would result in pain reduction.   "
174673|NCT00126750|"     To assist busy primary care clinicians in VA Community Based Outpatient Clinics (CBOCs) in     managing complex patients by providing a single, interactive, and personalized source of     information regarding applicable guidelines for post-MI patients. Specifically, 1) the     investigators will identify barriers to provider adherence to guidelines within VHA clinics;     2) Apply guideline-based performance measures to electronic medical records (CPRS) and     associated administrative data; 3) Implement the interactive Internet intervention developed     by the NHLBI study, after inclusion of VA-specific components, including performance feedback     for CBOC clinicians; and 4) Test hypotheses on the intervention's effectiveness,     sustainability, and cost-effectiveness in both the VA and Medicare populations. This will     include a randomized controlled trial with the CBOC as a unit of randomization.   "
174674|NCT00126763|"     The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in     providing relief of non-malignant chronic pain.   "
174675|NCT00126776|"     The purpose of this study is to determine if a program of self management and case management     reduces hospitalizations and urgent care visits for patients with chronic obstructive     pulmonary disease (COPD).   "
174676|NCT00126789|"     The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in     providing relief of cancer pain.   "
174850|NCT00130351|"     This study is designed to investigate the ability of patients with asthma to properly use a     new multi-dose dry powder inhaler (MDDPI) device in a real-life situation.   "
174679|NCT00126828|"     Patients who have limited stage small cell lung cancer are presently treated with     chemotherapy and radiation therapy (RT). Despite this aggressive treatment the vast majority     of patients will have their cancer recur after treatment. A recurrence is not curable at this     time, therefore efforts to reduce recurrence rates are desirable. Due to the sensitivity of     surrounding structures in the chest to radiation, it has not been possible to give doses that     can cure most tumours. Three-dimensional conformal radiotherapy is a special form of     radiation therapy that allows doctors to reduce the amount of radiation dose to normal     tissues and therefore reduce toxicity and in turn, let them safely increase the dose to     tumours. The purpose of this study is to determine whether the combination of     three-dimensional conformal radiotherapy and chemotherapy will be a more effective treatment.     If the treatment is found to be safe for the first group of patients, then the total     radiation dose will be increased for the next group of patients who are treated on this     study.   "
174680|NCT00126841|"     Patients with more advanced stages of cervix cancer are treated by radiotherapy. Overall,     more than 50% are cured. Approximately half of those patients not cured have current cancer     in the irradiated volume. Higher doses of radiation would be expected to cure more patients.     To give high doses of radiation safely, the investigators need to know very precisely where     the cancer is and then they can use new technology available at the Cross Cancer Institute     (tomotherapy) to target the cancer precisely, giving higher doses to the cancerous tissues     and lower doses to the non-cancerous tissues.      This study of ten patients with cervical cancer will investigate the added value of MRI     scanning on precise tumor definition to facilitate more accurate radiotherapy treatment     planning. For this study, patients will be treated in the conventional way with conventional     doses. The investigators hope that treatment for future patients will be planned with MRI     data and that they will be treated to higher doses of tomotherapy.   "
174681|NCT00126854|"     The purpose of this study is to establish the correct scanning parameters for obtaining good     quality 3 Tesla (3T) magnetic resonance spectroscopy images (MRSI) of the prostate gland     before and after brachytherapy implantation for prostate cancer. Three Tesla MRSI may be a     valuable additional diagnostic and follow-up investigation for prostate cancer patients.   "
174682|NCT00126867|"     Cancers of the colon and rectum are the third most common cancers in Canadian males and     females. The initial therapy of colorectal cancer is surgery to remove the cancer and nearby     lymph glands. If the cancer has spread to the lymph glands there is a high chance that the     cancer will come back. To reduce the risk of the cancer recurring, patients are treated with     an anticancer drug capecitabine. This study will determine if a simple blood test can predict     which patients are at risk for developing side effects from this chemotherapy. In addition,     participants of this study will be followed to determine if this same blood test will predict     which patients will have their cancer relapse.   "
174683|NCT00126880|"     The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is     in treating HIV-1 infected people who have failed treatment with lamivudine.   "
174684|NCT00126893|"     This is a single center Phase 1 study to evaluate the safety, pharmacokinetics and     pharmacodynamics of CC-401 in subjects with refractory acute myelogenous leukemia.   "
174686|NCT00126919|"     Children ages 3-17 who are undergoing port access receive both standard care, topical     medicine for numbing (LMX4), and the study intervention which utilizes ultrasound to speed     the onset of LMX4 from 30 minutes to 5 minutes. The procedures will be performed on 2     separate visits to the clinic. The child's pain with the access procedure is evaluated.   "
174689|NCT00126958|"     This randomized clinical multicentre trial aims to evaluate the efficacy of microsatellite     analysis on voided urine to detect tumour recurrences in the follow-up of patients with     superficial urothelialcell carcinoma (UCC). Further, this study aims to identify subgroups of     patients with a low risk of tumour recurrence using clinico-pathologic tumour characteristics     in combination with a genetic marker (FGFR3 gene), such that the frequency of follow-up     contact can be reduced. The overall objective is to reduce the frequency of cystoscopy during     follow-up in patients with superficial UCC, leading to an improvement in quality of life at     equal or lower costs. This study evaluates the cost-effectiveness of follow-up in bladder     cancer.   "
174690|NCT00126971|"     Controlling malaria during pregnancy is a vital strategy in decreasing maternal and child     mortality in Africa. There are data from clinical trials and program evaluations in stable     transmission areas that show that intermittent preventive treatment (IPT) with two doses of     sulfadoxine-pyrimethamine (SP) is safe, efficacious, and effective in preventing maternal     anemia, placental parasitemia, and low birth weight (LBW). SP is also the first-line drug for     the case-management of malaria in pregnancy. Resistance to SP, however, is increasing rapidly     in East and Central Africa and compliance to the rescue treatment, 7-days of oral quinine, is     low. There is an urgent need to find effective, safe and practical alternative drugs for the     treatment of malaria in pregnancy. The synergistic antifolate combination     chlorproguanil-dapsone (CD), has recently become available. It is inexpensive, well     tolerated, is given as single daily treatment doses for 3 days, and is effective in the     treatment of drug-resistant falciparum malaria.      The investigators propose a small pharmacokinetic study of CD to determine if current fixed     combination CD tablets provide an adequate dosage in pregnancy. Such a study is a necessary     precursor to any large Phase II trials to further evaluate the safety and efficacy of CD for     use in pregnant women. To accomplish this, a group of 66 parasitemic pregnant women in this     open label trial will receive CD and be sampled by venipuncture at two of the seven follow-up     visits scheduled for pharmacokinetic analyses, such that 11 patients are sampled at each of     12 time points. To serve as a reference, 66 non-pregnant women with symptomatic malaria will     also be treated with CD and will have identical pharmacokinetic (PK) analyses performed.      Pregnant women greater than or equal to 20 weeks gestation with P. falciparum parasitemia on     peripheral blood film will be given an insecticide-treated net (ITN) and will receive CD (1.5     or 2 tablets daily for 3 days, depending on weight). All study drug dosing will be observed.     Women will be examined, adverse events recorded, and blood samples collected at days 0, 1, 2,     3, 7, 14, 21, and 28 after treatment, and thereafter every 14 days until delivery. Women will     be further randomized to receive additional blood draws for pharmacokinetic analyses using a     modified rich PK schedule. Each woman will only have 2 additional blood draws. Women at     delivery will have peripheral and placental blood films prepared. Newborns will be weighed,     examined, and gestational age determined. Women requiring antimalarial treatment for     parasitemia at any point between enrollment and delivery will be treated with quinine.     Adverse effects will be assessed at each scheduled visit, any sick visits during the study,     and at delivery.   "
174691|NCT00126984|"     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one     dose of four different formulations of the MenACWY conjugate vaccine when given to healthy     children aged 12 14 months and 3 5 years. The selection of the best formulation will be based     on data obtained up to one month after the vaccine dose. The Protocol Posting has been     updated in order to comply with the FDA Amendment Act, September 2007.   "
174692|NCT00126997|"     This is a study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals     live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their     second year of life.   "
174697|NCT00127062|"     Acute exposure to diesel exhaust under normal city conditions leads to a worsening of     symptoms of asthma, with reduction in lung function in asthmatic nonsmoking adults, dependent     on the exposure dose and on the background severity of asthma.      The worsening asthma is accompanied by increased oxidative stress and inflammation in the     lungs.   "
174698|NCT00127075|"     Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their     childbearing years. It is an autoimmune disease of the central nervous system (CNS), which     results in a chronic focal inflammatory response with subsequent demyelination and axonal     loss. Recent prospective studies reported a significant decline by two-thirds in the rate of     relapses during the third trimester of pregnancy and a significant increase by two-thirds     during the first three months post-partum by comparison to the relapse rate observed during     the year prior to the pregnancy (Confavreux et al., 1998). These dramatic changes in the     relapse rate occur at a time when the impregnation of many substances (among which, sexual     steroids) is at its highest, before a dramatic decline to the pre-pregnancy levels,     immediately following delivery.      It may be hypothesized that sexual steroids could exert beneficial effects through a     modulation of the immune state with a lowering of the pro-inflammatory lymphocyte responses     of the Th1 type and an enhancement of the anti-inflammatory responses of the Th2 type. They     may also play a direct role in the remyelination of central nervous system lesions, as they     do in the peripheral nervous system. The POPART'MUS study is a European, multicentre,     randomized, placebo-controlled and double-blind clinical trial, which aims to prevent MS     relapses related to the post-partum condition, by administering high doses of progestin     (nomegestrol acetate), in combination with endometrial protective doses of estradiol.     Treatment will be given immediately after delivery and continuously during the first three     months post-partum. Assuming the results of the trial to be positive, this new treatment     could be considered in the relapsing-remitting phase of the disease in women afar from     pregnancy and post-partum.   "
174699|NCT00127088|"     This is a prospective phase II study of peri-operative docetaxel plus laparoscopic radical     prostatectomy in patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate     and a risk of relapse after radical prostatectomy.   "
174700|NCT00127101|"     This is an investigational study that increases the dosage to determine the     safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with     Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one     prior systemic therapy.   "
174701|NCT00121030|"     The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia     Treatment (PSQ-AT) in gynecological cancer patients treated with darbepoetin alfa or     recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.   "
174702|NCT00121043|"     The primary purpose of this study is to assess the ease-of-use of SimpleJectTM compared to     pre-filled syringe(s) when using Kineret® in RA subjects. The secondary purpose of this study     is to assess the level of fear and anxiety associated with the use of both injection methods,     to assess safety when using SimpleJectTM and to evaluate the Ease-of-Administration     Questionnaire (EAQ) in terms of the quality of items, item performance, and the instrument     reliability.   "
174703|NCT00121056|"     The purpose of this study is to determine if Enbrel® or Kineret® will have a positive effect     on subject functionality as measured by the Health Assessment Questionnaire Disability Index     (HAQDI).   "
174704|NCT00121069|"     This pilot study is designed to assess the efficacy of escitalopram in the treatment of     specific phobia in adult outpatients.   "
174705|NCT00121095|"     The purpose of this study is to investigate the safety, tolerability and anti-tumor effects     of treatment with samarium Sm-153 lexidronam in combination with docetaxel in patients with     castrate metastatic prostate cancer.   "
174706|NCT00121108|"     This study (MI-CP117) is a Phase 3, randomized, double-blind, placebo-controlled trial     designed to determine if MEDI-524 compared to placebo will result in clinical efficacy in the     reduction of RSV hospitalization in otherwise healthy Native American Indian Infants in the     Southwestern United States during their first RSV season.   "
174707|NCT00121121|"     Intramuscular (IM) administration of HIV lipopeptide vaccines have been shown to be able to     induce HIV-1-specific T cell-mediated immune responses. The objective of this trial was to     evaluate the safety and immunogenicity of LIPO-4 vaccine (HIV lipopeptides including 4     peptides from Gag, Pol, RT and Nef HIV-1 proteins, each peptide linked to TT) intradermally     (ID) compared to IM administration.   "
174708|NCT00121134|"     The purpose of this research study is to study the effects (good and bad) of bevacizumab     alone, bevacizumab with low-dose continuous chemotherapy (called metronomic chemotherapy), or     bevacizumab with capecitabine, on you and your cancer. The goals of the study will be to:        -  Examine the safety of these drugs        -  See how easy or difficult it is to be treated with them        -  Monitor for any signs of recurrent cancer        -  Look at blood markers that might indicate how the treatment is working   "
174709|NCT00121147|"     The purpose of this study is to compare the additive effect on eye pressure of Azopt and     Alphagan P to Travatan.   "
174710|NCT00121160|"     The proposed investigation will conduct a randomized, clinical trial to test the efficacy of     a cognitive behavioral stress management (CBSM) group intervention on immune response to     vaccine and distress among women at elevated risk for breast cancer.      Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and     secondary antibody response to vaccines compared to women in the comparison group.      Hypothesis 2: Women who participate in a 10-week CBSM group intervention will report lower     levels of distress immediately after and 6 months after the intervention compared to women in     the comparison group.   "
174711|NCT00121173|"     RATIONALE: Vaccines made from protein and DNA may help the body build an effective immune     response to kill abnormal cells in the cervix. The use of vaccine therapy may prevent     cervical cancer.      PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy     and to see how well it works in preventing cervical cancer in patients with cervical     intraepithelial neoplasia and human papillomavirus.   "
174785|NCT00129493|"     This study investigates group medical visits as a quality improvement strategy for     hypertension. It studies group visits in which patients see their own primary care provider     together with other patients who have hypertension. The group visits are intended to enhance     the patient's self-efficacy for self-management of their chronic disease (hypertension).   "
174712|NCT00121186|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a     donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer     cells. It also stops the patient's immune system from rejecting the donor's stem cells. The     donated stem cells may replace the patient's immune system and help destroy any remaining     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can     also make an immune response against the body's normal cells. Giving tacrolimus and     methotrexate after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving fludarabine together with melphalan     followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor     stem cell transplant for relapsed lymphoma.   "
174713|NCT00121199|"     This phase II trial is studying how well giving combination chemotherapy together with     rituximab and bevacizumab works in treating older patients with stage II, stage III, or stage     IV diffuse large B-cell lymphoma. Drugs used in chemotherapy work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal     antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways.     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help     kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of     cancer cells by blocking blood flow to the cancer. Giving combination chemotherapy together     with monoclonal antibodies may kill more cancer cells.   "
174714|NCT00121212|"     RATIONALE: Diagnostic procedures, such as positron emission tomography using carbon-11     acetate, may help find metastases from prostate cancer and may help predict whether prostate     cancer will come back after treatment.      PURPOSE: This clinical trial is studying how well positron emission tomography using     carbon-11 acetate works in finding metastases and predicting recurrence in patients with     prostate cancer who are at risk for recurrence after treatment.   "
174715|NCT00121225|"     This phase II trial is studying how well vorinostat works in treating patients with     metastatic or unresectable melanoma. Vorinostat may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
174716|NCT00121238|"     This phase II trial is studying how well cilengitide works in treating patients with prostate     cancer. Cilengitide may stop the growth of prostate cancer by blocking blood flow to the     tumor   "
174718|NCT00121264|"     This phase I trial is studying the side effects and best dose of 17-AAG when given together     with sorafenib in treating patients with unresectable or metastatic solid tumors. Drugs used     in chemotherapy, such as 17-AAG, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood     flow to the tumor. Giving 17-AAG together with sorafenib may kill more tumor cells.   "
174719|NCT00121277|"     RATIONALE: Drugs used in chemotherapy, such as vorinostat and capecitabine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving more than one drug (combination chemotherapy) may kill more     tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and     capecitabine in treating patients with unresectable or metastatic solid tumors.   "
174720|NCT00121290|"     This phase I trial studies the side effects and best dose of SJG-136 in treating patients     with solid tumors that are metastatic or cannot be removed by surgery. Drugs used in     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.   "
174721|NCT00121303|"     RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. It is not yet known     whether cytarabine and daunorubicin followed by gemtuzumab ozogamicin is more effective than     cytarabine and daunorubicin in treating acute myeloid leukemia or myelodysplastic syndromes.      PURPOSE: This randomized phase III trial is studying cytarabine and two different doses of     daunorubicin to see how well they work compared to cytarabine and daunorubicin followed by     gemtuzumab ozogamicin in treating older patients with acute myeloid leukemia or     myelodysplastic syndromes.   "
174722|NCT00121316|"     This study is not being conducted in the United States.      Patients who are intolerant of topical corticosteroids (TCS) have either experienced an     adverse event resulting from the use of TCS, or require unacceptable levels of exposure to     TCS in order to control their AD. This is of particular concern for patients with recurrent     flares on delicate skin areas such as the head and neck.      The purpose of this study is to investigate whether pimecrolimus cream 1%, a non-steroidal     anti-inflammatory drug, is efficacious in treating mild to moderate head and neck AD in     patients who are intolerant of, or dependent on topical corticosteroids.   "
174723|NCT00121329|"     Recent studies have investigated the use of local anesthetics (i.e. lidocaine, mepivacaine)     to lessen the pain experienced with minor gynecologic procedures such as endometrial biopsy     and office hysteroscopy. Local anesthetic injected into the uterine cavity has been     demonstrated effective in some studies at decreasing patient pain associated with these     intrauterine procedures at an anesthetic concentration of at least 2%. Based on this     evidence, we hypothesized that an intrauterine lidocaine infusion may reduce patient pain     during first trimester abortions.   "
174724|NCT00121355|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     examine whether nurses prefer to use the NovoFine® Autocover Needle or the BD Safety Glide     (TM) Syringe (only) in a hospital setting. The number of needle stick injuries will also be     evaluated and whether these hospital nurses prefer the safety features of the NovoFine®     Autocover Needle versus those of the BD Safety Glide (TM) Syringe. The identified hospital     nurses will evaluate the two types of needles during standard administration of insulin to     patients being treated for diabetes.   "
174725|NCT00121368|"     Smoking can contribute to many health problems for mothers and their babies. In developing     countries, there is little information about the number of pregnant women that smoke and the     reasons why some pregnant women choose to smoke. The purpose of this multi-site tobacco use     survey is to obtain information on knowledge, attitudes and behaviors among pregnant women in     diverse populations regarding tobacco products.   "
174726|NCT00121381|"     Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin     elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the     T-cell activation. These cells are involved in the inflammatory component of the disease.     This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid     treatment (commonly used in eczema) in patients with severe atopic dermatitis.   "
174727|NCT00121394|"     Infection is a major health problem during birth in Pakistan. This study will look at the     possibility of using a septic wash to help improve health during birth in Karachi, Pakistan.   "
174728|NCT00121407|"     The purpose of this study is to demonstrate that Visudyne therapy in patients who have occult     with no classic subfoveal choroidal neovascularization (CNV) lesions will, with an acceptable     safety profile, significantly reduce the risk of vision loss compared with placebo (sham     treatment).   "
174729|NCT00121420|"     The primary purpose of the study is to evaluate if motexafin gadolinium with whole brain     radiation therapy followed by a stereotactic radiosurgery boost is a safe and effective     treatment.   "
174730|NCT00121433|"     The purpose of this trial was to determine if injections of leptin would improve vascular     function in normal-weight, healthy volunteers.   "
174731|NCT00121446|"     In the setting of acute myocardial infarction (heart attacks), the principle objective of the     WEST Study is to compare the impact on clinical outcomes of 3 different treatment strategies.     The first is using medical (drug) therapy alone with standard care. The second strategy is     identical medical (drug) therapy as the first group combined with early heart catheterization     (within 24 hours) for angiography and if required, intervention. The third treatment strategy     is direct admission (within 3 hrs) to the heart catheterization lab for angioplasty.      WEST patients will be enrolled at first medical contact (using emergency medical services,     e.g. ambulance) if possible or through Emergency Departments in participating health care     facilities.   "
174732|NCT00127114|"     The purpose of this clinical trial is to test whether or not the medication amantadine is     effective in reducing behavioral disturbances in patients with frontotemporal dementia.   "
174739|NCT00127205|"     RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in     patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more     effective than clodronate or ibandronate in treating breast cancer.      PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works     compared to clodronate or ibandronate in treating women who have undergone surgery for stage     I, stage II, or stage III breast cancer.   "
174740|NCT00127218|"     The purpose of this study is to investigate the added benefits of increased high-density     lipoprotein (HDL) cholesterol serum levels over and above those achieved by lipid lowering     therapy guided by current guidelines, in older individuals with cardiovascular disease.   "
174741|NCT00127231|"     The purpose of this study is to determine whether two brief counseling sessions reduce     drinking and improve health outcomes in HIV-positive women who drink at heavy/hazardous     levels. Also, the study seeks to compare hazardous drinking versus nonhazardous drinking     women on a variety of alcohol, HIV and life quality outcome measures.   "
174742|NCT00127244|"     The purposes of this study are to:        1. compare the clinical effectiveness of a traditional and a medical model of periodontal          therapy; and        2. determine the value of the two approaches to periodontal therapy.   "
174743|NCT00127257|"     Constipation affects 4% of adults in the United States (U.S.). An estimated half of     constipated patients are unable to relax pelvic floor muscles during defecation, a type of     constipation called pelvic floor dyssynergia (PFD). Biofeedback has been recommended for the     treatment of constipation because uncontrolled studies over the past 10 years suggest that     these treatments are as effective as medical or surgical management and involve no risk.     However, placebo-controlled trials are still lacking. The aims of this study are:        -  to compare biofeedback to alternative therapies for which patients have a similar          expectation of benefit;        -  to identify which patients are most likely to benefit; and        -  to assess the impact of treatment on quality of life.   "
174744|NCT00127270|"     This study is designed to investigate the efficacy and safety of treatment of overactive     bladder with darifenacin administered alone or in conjunction with behavioral modification     therapies.   "
174745|NCT00127283|"     This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South     America.      The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog     alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more     patients will recover without severe permanent disability after acute treatment with     Recombinant Factor VIIa by reducing further intracerebral bleeding.   "
174746|NCT00127296|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     compare desired (target) with actual target amounts of insulin dispensed using NovoLog® Mix     70/30 FlexPen® and vial and syringe in subjects with type 2 diabetes mellitus. No insulin is     administered in this trial - insulin is dispensed into an empty vial.   "
174747|NCT00127309|"     Glutathione (a tripeptide of 3 amino acids - glutamic acid, cysteine and glycine) plays a     great role in homeostasis, especially as a potent anti-oxidant.      As an anti-oxidant, it conjugates with xenobiotics using glutathione-S-transferase (GST) and     excretes in urine as mercapturic acid.      In 1986, Casciani et al at the University of Milan, studied the effect of glutathione on     blood alcohol, acetaldehyde and hepatic triglyceride levels and found a significant reducing     effect.      The blood acetaldehyde, which is the metabolic product of ethyl alcohol may have a     correlation with hangover symptoms. This study is designed to find this correlation using     blood alcohol, blood acetaldehyde levels and the Hangover Symptoms Scale according to the     Slutske et al study.   "
174873|NCT00130650|"     The purpose of this study is to investigate the use of a new vapocoolant spray, Pain Ease, to     reduce intravenous (IV) insertion pain in school-aged children receiving treatment in the     Emergency Department.   "
174748|NCT00127322|"     Many people with heart failure either die or are admitted to the hospital in the first few     months after the condition is diagnosed. The reasons for this are currently unclear- but may     be due to worsening heart failure or other medical conditions such as angina, heart attack or     sudden electrical problems of the heart. The investigators propose to recruit and follow-up     450 people, with a new diagnosis of heart failure for a minimum of six months in a     multi-centre observational study at two hospital sites: The Hillingdon (Uxbridge) and The     Conquest (Hastings) hospitals. The total study duration will be two years. People will be     recruited after a diagnosis of heart failure is made and the study will assess reasons for     death or admission to hospital and the psychological impact of the condition on both patients     and their carers. This is an observational study and no change will be made to patients’     conventional treatment.      Hypotheses:        1. The high mortality and hospitalisation rate in the early period after diagnosis of heart          failure is related to progressive pump failure; or        2. The high mortality in the early period after the diagnosis of heart failure is related          to co-morbid events- principally major coronary events such as myocardial infarction or          acute coronary syndrome.      This research should help to identify ways of improving the outlook for people with newly     diagnosed heart failure. The analysis of the data generated by this study will be supervised     by a statistician. Clinical and demographic data will be described using mean + standard     deviation, for continuous variables, and absolute numbers and percentages for categorical     variables. Group differences will be examined by t-tests for continuous variables and     Chi-square (x2) test for categorical variables. Survival will be reported in terms of     Kaplan-Meier curves with differences analysed by Cox proportional hazards.   "
174749|NCT00127335|"     There is a significant proportion of patients complaining of muscle symptoms while on statin     therapy who have a measurable difference in muscle strength or endurance and whose muscle     biopsies are diagnostic for myopathy.   "
174750|NCT00127348|"     The objective of the study is to evaluate the effect of CPAP over the incidence of     cardiovascular events and diagnosis of arterial hypertension in patients with sleep apnea.      The hypothesis of the study is the following: The existence of sleep disordered breathing in     the general population is associated to an increased incidence of arterial hypertension and     to an increased risk of suffering cardiovascular disease. CPAP corrects respiratory disorders     during sleep. Treatment with CPAP in subjects with sleep disordered breathing without daytime     sleepiness reduces the incidence of systemic arterial hypertension and cardiovascular     complications.      The end points of the study are new diagnosis of arterial hypertension and new cardiovascular     events.      All patients, after randomization, will be followed for three years.   "
174751|NCT00127361|"     The purpose of this study was to compare labor outcomes in women accompanied by an additional     support person (doula group) with outcomes in women who did not have this additional support     person (control group).      The current study was designed with the benefits of continuous labor support in mind as well     as the need for a cost-effective, affordable program to provide those services for low-income     women. Its purpose was to evaluate the effects of continuous labor support provided by a     female companion of the pregnant person's choosing who, with the mother, had participated in     an educational program to teach her how to provide continuous labor support.   "
174752|NCT00127374|"     The specific aims of this study are to document the co-existence of depression, low     self-esteem, and high-risk behaviors among overweight and at-risk for overweight female     adolescents; and decrease the prevalence of high-risk behaviors by improving depressive     symptoms/signs and self-esteem through weight management intervention strategies that     encourage long-term mental and physical well being. The proposed research will test the     following hypotheses:        -  Overweight and at-risk for overweight female adolescents have poor self-esteem that may          mask depression and mediate high-risk behaviors; and        -  Improved weight perception decreases participation in high-risk behavior secondary to          improved self-esteem and depression.   "
174753|NCT00127387|"     Patients who receive radiation therapy often have fatigue or a decrease in feeling well     causing a wasting away. For patients with advanced disease of lung cancer, prostate cancer,     or cancer that has spread to the bone, it is hoped that this drug may decrease this. If     patients feel better during treatments they can complete the therapy without any breaks in     treatment. For treatment to be most effective, it should be given in the amount needed, on a     particular schedule.   "
174754|NCT00127400|"     The purpose of this study is to see how different forms of Anger Management compare in     reducing anger and impulsive aggressive symptoms in people. Anger Management is a common     form of talk therapy used to help people with anger problems. There are different types of     talk therapy used to help people for anger problems and this study will compare two types     of talk therapy in people with Intermittent Explosive Disorder (IED). IED is a disorder in     which there are frequent and sudden outbursts of anger (yelling, throwing and breaking     things, hitting people) that lead to problems with other people socially or at work.   "
174755|NCT00127413|"     The purpose of this study is to examine the efficacy of an integrated treatment for Veterans     with comorbid chronic pain and posttraumatic stress disorder (PTSD). It is hypothesized that     Veterans who receive the integrated treatment will report more positive outcomes than     individuals who are assigned to treatment as usual, pain treatment, or PTSD treatment.   "
174756|NCT00127439|"     The purpose of this study is to collect data regarding the various aspects of locomotor     training and how it affects different people with spinal cord injury (SCI).   "
174757|NCT00127452|"     The Alpha Omega Trial is a randomized, placebo-controlled, double-blind dietary intervention     study in 4837 postmyocardial infarction patients in the Netherlands to examine whether     incidence of cardiovascular diseases during 40 months of follow-up can be prevented by low     doses of omega-3 polyunsaturated fatty acids. The key objectives are:        -  to examine the effect of low-dose supplementation (400 mg/day) of eicosapentaenoic acid          and docosahexaenoic acid on incidence of cardiovascular diseases; and        -  to examine the effect of low-dose supplementation (2 g/day) of alpha-linolenic acid on          incidence of cardiovascular diseases.   "
174758|NCT00129142|"     Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural     hormone called testosterone. This type of therapy is very effective for the treatment of     prostate cancer. However, one of the side effects is bone loss or thinning of the bones that     can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The     purpose of the study is to determine whether or not the addition of toremifene citrate (the     study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate     its impact on side effects associated with testosterone reduction therapy.   "
174799|NCT00129675|"     The overall goal of this study is to evaluate the use of dopamine transporter (DAT) imaging     as a diagnostic tool in subjects with early parkinsonian symptoms, in whom Parkinson's     disease (PD) or parkinsonian syndrome (PS) is suspected, but the diagnosis remains unclear     from a clinical standpoint.   "
174759|NCT00129155|"     In this study, treosulfan is evaluated for conditioning in allogenic stem cell     transplantation. The procedure and the follow-up are the same as in standard allogenic     transplant.      The donor is unrelated (identical HLA). The graft is haematological peripheral blood stem     cell.      The conditioning with reduced intensity is: fludarabine (from day -6 to day -2), treosulfan     (from day -6 to day -4) and thymoglobuline (from day -2 to day -1).   "
174760|NCT00129168|"     Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing     or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making     cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and     cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.   "
174761|NCT00129181|"     This study investigates whether there is a change in 123iodine-2ß-     carbomethoxy-3ß-(4-iodophenyl) tropane ([123I]ß-CIT) uptake after short-term treatment with     levodopa compared to either dopamine agonist or placebo.   "
174762|NCT00129194|"     The primary purpose of the study is to assess the safety and pharmacokinetics of KP-1461     given every 12 hours for 14 days when administered to HIV+ patients who have failed multiple     highly active antiretroviral therapy (HAART) regimens. Patients currently on HAART will be     required to discontinue all HAART medications for up to 6 weeks after screening eligibility     has been determined.   "
174763|NCT00129207|"     The purpose of this study is to investigate how ketoconazole (Nizoral) affects the     pharmacokinetics (how the study drug is affected by the body and broken down) and     pharmacodynamics (how the study drug acts on the body) of the active ingredient in the study     drug Velcade (bortezomib).   "
174764|NCT00129220|"     The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic     or mixed symptoms associated with bipolar I disorder.   "
174765|NCT00129233|"     Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin     Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the     cardiac- and reno-protective effects of these drugs. However, these recommendations could not     be extrapolated to Japanese patients, because Japan has been known as a country with a low     incidence of coronary artery disease and a high incidence of cerebrovascular disease.     Furthermore, calcium channel blockers (CCBs) also were protective against renal function as     well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test     whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.   "
174766|NCT00129246|"     This study will test a combination of the drugs naltrexone and bupropion with     weight-concerned smokers to investigate whether or not this combination of drugs improves     smoking cessation quit rates and minimizes post quit weight gain.   "
174767|NCT00129259|"     Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 [Ala-Ala],teplizumab, MGA031) is a humanized     antibody that is commonly used to prevent organ rejection. The purpose of this study is     determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1     diabetes.   "
174768|NCT00129272|"     Little is known about the best ways to help young people stop smoking. Bupropion (a     medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The     purpose of this study is to determine if bupropion is also effective in treating smokers     between the ages of 12 and 25 years old. This study also compares the effectiveness of     bupropion used as a supplement to behavioral treatment versus behavioral treatment used     alone. In addition, the study evaluates whether hormonal response to stress measured prior to     the start of treatment predicts whether individuals respond well to treatment with     medication.   "
174769|NCT00129285|"     Despite years of active research, there are still no approved medications for the treatment     of cocaine dependence. The purpose of this study is to determine the effectiveness of     modafinil in treating cocaine-dependent individuals.   "
174770|NCT00129298|"     Many opioid-dependent individuals are also dependent on cocaine. Methadone is a widely used     and effective method for treating opioid dependence. However, it is not effective in treating     other drugs of abuse. The purpose of this study is to determine the effectiveness of another     drug, tiagabine, for treating cocaine dependence in opioid-dependent individuals already     receiving methadone treatment.   "
174771|NCT00129311|"     Despite the widespread use of nicotine replacement therapies for the treatment of nicotine     dependence, many smokers are still unable to quit smoking. The purpose of this study is to     determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking.   "
174772|NCT00129324|"     The goal of the HOME Study is to quantify the impact of low-level fetal and early childhood     exposures to environmental toxicants including lead, mercury, and other metals, pesticides,     polychlorinated biphenyls (PCBs), persistent organic pollutants (PBDEs/PFCs), phthalates,     phenols, environmental tobacco smoke, and alcohol on child development, neurobehavior,     health, and growth. The HOME Study will also evaluate meconium as a biomarker for fetal     exposure and test the effectiveness of home repairs to control lead hazards and injuries in     early childhood.   "
174773|NCT00129337|"     The purpose of this study is to determine the safety of bavituximab when administered via a     vein, and to examine how bavituximab behaves in the body - how quickly it is taken up by the     body and how long it stays there. The effect of bavituximab on tumor responses will also be     examined.   "
174783|NCT00129467|"     The purpose of this study is to determine whether methylphenidate is an effective treatment     for depression and to document the safety and tolerability of methylphenidate in combination     with an Selective Serotonin Reuptake Inhibitor (SSRI) in SSRI treated, terminally ill,     hospice and palliative care cancer patients. The investigators hypothesize that depressed     hospice and palliative care patients will be more likely to have a 50% reduction in scores on     a clinical measure of depression after treatment with Methylphenidate plus an SSRI compared     to those patients who are taking a placebo plus an SSRI.   "
174784|NCT00129480|"     The primary objective of this study is to determine to what extent a collaborative     intervention improves chronic pain-related outcomes in a VA primary care setting. We will     also determine to what extent the intervention affects 1) treatment of co-occurring     depression, 2) adherence of providers to guidelines for treating chronic pain, and 3) patient     and provider satisfaction and attitudes related to chronic pain treatment.   "
174774|NCT00129350|"     At present, a specific community based rehabilitation programme for lung or heart-lung     transplant recipients does not exist. 160 hospitals throughout the United Kingdom (UK) offer     pulmonary rehabilitation programmes. The programmes operate under evidence-based guidelines     as outlined by the Chartered Society of Physiotherapy. Increasing evidence shows that     rehabilitation programmes help improve performance, exercise endurance, and quality of life;     and reduce symptoms and demand on health-care resources. This study proposes to compare the     outcomes of lung and heart-lung transplant patients attending local pulmonary rehabilitation     against others receiving the Trust's current document-based programme. The study is a     randomized controlled trial:        -  Control Arm: Those patients randomized to the 'control' arm will receive the Trust's          standard rehabilitation programme that consists of an information pack supplied upon          discharge. They will then complete and undertake the following tests: Short-Form 36 (SF          36; version 2) Questionnaire, Chronic Respiratory Questionnaire (CRQ-SR), Incremental          Shuttle Walk Test and Spirometry forced expiratory volume in 1 second (FEV1) and forced          vital capacity (FVC). The patient will follow the information contained in the          information pack and the above tests and questionnaires will be repeated 6 months post          discharge.        -  Experimental Arm: A patient who is randomized to the 'experimental' arm will be asked to          complete the following tests upon discharge: Short-Form 36 (SF 36; version 2)          Questionnaire, Chronic Respiratory Questionnaire (CRQ-SR), Incremental Shuttle Walk Test          and Spirometry FEV1 and FVC. Three months post discharge, the patient will be enrolled          into a local pulmonary rehabilitation programme. The programme is typically structured          to last 6-12 weeks. The above tests and questionnaires will be repeated 6 months post          discharge.      To measure the effectiveness of either the information pack or the rehabilitation programme     the following endpoints will be subjected to analysis in both the experimental and the     control group:        -  Short-Form 36 Questionnaire;        -  Chronic Respiratory Questionnaire;        -  Incremental Shuttle Walk Test;        -  Borg Scale;        -  Spirometry FEV1 and FVC;        -  Hospital re-admission rates and mortality rates.      The undertaking of a multidisciplinary-led programme of rehabilitation facilitates a better     quality of life than a document-based rehabilitation programme in lung and or heart-lung     transplant out-patients.      The aim of the study is to construct an optimal programme of rehabilitation in lung or     heart-lung patients.   "
174775|NCT00129363|"     The objective of this study is to evaluate the long-term safety of carvedilol in pediatric     patients with chronic heart failure, who completed the Pediatric Carvedilol Study 321.     Carvedilol will be provided as open-label therapy for a period of at least 6 months (or until     termination of the study) by SmithKline Beecham Corporation d/b/a GlaxoSmithKline (GSK) or     the University Sponsor.   "
174776|NCT00129376|"     Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions).      The pathological complete response rate obtained in previous studies is around 12%. The     expected pathological complete response rate in this study is 25%. With an alpha error of     0.05 and a beta error of 0.2, and following Simon´s 2 phase test, 19 patients are needed     initially. With 2 pathological complete responses, patient recruitment will continue until     approximately 61 patients are recruited. Twelve pathological complete responses are needed to     confirm the study hypothesis.   "
174777|NCT00129389|"     This is a prospective, open-label, randomized, phase III trial. Patients will be stratified     after breast surgery, as per investigational site; menopausal status; node negative     diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status     (positive versus negative). Patients will be randomized to:        -  FAC x 6 (cycles): 5-fluorouracil 500 mg/m2 + doxorubicin 50 mg/m2 + cyclophosphamide 500          mg/m2 day 1, every 3 weeks, for 6 cycles.        -  FAC x 4 (cycles) → Taxol® x 8 (cycles): 5-fluorouracil 500 mg/m2 + doxorubicin 50 mg/m2          + cyclophosphamide 500 mg/m2 day 1, every 3 weeks, for 4 cycles, followed by 8          administrations of weekly paclitaxel 100 mg/m2      Premenopausal women with hormone receptor positive tumors must receive tamoxifen 20 mg daily     for 5 years, after the end of chemotherapy.      Postmenopausal women with hormone receptor positive tumors are allowed to receive aromatase     inhibitors as initial adjuvant hormone therapy or after tamoxifen.      All patients with breast conservative surgery must receive radiotherapy.      Estimated 5-year disease-free survival in the control arm (FAC x 6) is expected to be 80%. It     is expected that disease-free survival will increase by 5% in the experimental arm     (FAC-paclitaxel). 906 patients per arm must be recruited, to detect this difference with an     alpha error of 0.05 and 80% power. Assuming a 6% post-randomization drop-out rate, 960     patients per arm are needed, 1920 in total.   "
174778|NCT00129402|"     This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to     evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages     10-17 years with Heterozygous Familial Hypercholesterolemia.   "
174804|NCT00129740|"     The goal of this clinical research study is to learn if an experimental agent, AMN107     (nilotinib), can help to control CML in chronic phase. The safety of this experimental agent     will also be studied.   "
175019|NCT00132639|"     The purpose of this study is to evaluate the safety and efficacy of the preoperative     docetaxel and docetaxel-cisplatin combination in c-stage IB/II NSCLC, and select the optimal     preoperative therapy for phase III trials.   "
174779|NCT00129415|"     The purpose of this investigation is to study the effectiveness of longer wavelength UVA1     (340-400nm) or shorter wavelength ultraviolet B [UVB] (290-320nm) irradiation in the     treatment of inflammatory skin conditions (such as: atopic dermatitis, psoriasis, mycosis     fungoides, alopecia areata, stretch marks and urticaria).      This research study aims to evaluate the effectiveness of an investigational device which is     similar in appearance to a tanning bed but which emits ultraviolet irradiation of a     specific wavelength known as UVA1. This device has not been approved by the Food and Drug     Administration (FDA) for general use in this country, as of yet, but it has been used quite     successfully in Europe for several years in treating such conditions as scleroderma, atopic     dermatitis, urticaria pigmentosa and other skin conditions.      Instead of UVA1 therapy, patients may receive ultraviolet radiation of a specific wavelength     known as UVB. UVA1 light is a longer wavelength and therefore a lower energy wavelength than     UVB. UVB light is often the light associated with getting a sunburn since it has a higher     level of energy. UVB light has been used successfully in the treatment of many skin     conditions.   "
174780|NCT00129428|"     This research study will evaluate the effectiveness of high dose UVB light therapy in the     treatment of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn     scars, granuloma annulare or related conditions.   "
174781|NCT00129441|"     The purpose of this research study is to determine whether a short-term administration of an     investigational study drug may provide evidence of improvement in cognitive functioning in a     group of stable male subjects with schizophrenia.   "
174782|NCT00129454|"     Effective treatments have been developed to ameliorate symptom-related distress and reduce     unnecessary healthcare utilization using cognitive-behavioral techniques (CBT) . However     there is a major limitation of this treatment is that patients must attend sessions in     person. The specific aims of the study are to: (1) Determine the clinical efficacy of     Telephone CBT for veterans with GWI who are frequent consumers of ambulatory medical care;     (2) Determine whether CBT for veterans with GWI leads to a reduction in the cost of VA health     care; and (3) Develop a statistical model of treatment seeking in veterans with GWI who are     frequent consumers of ambulatory medical care.   "
174786|NCT00129506|"     Background: In most countries in which abortion is legal, medical abortions are induced with     mifepristone and misoprostol. Since mifepristone is expensive and unavailable in many     countries, it is important to find other regimens. Methotrexate, which is used with     misoprostol in Canada, is also difficult to obtain in many countries. Misoprostol is     inexpensive and available in almost all countries. A report from Nigeria found that 98% of     100 women aborted within 24 hours of using misoprostol given both sublingually and vaginally.      Method: This will be a randomized controlled trial of the usual regimen used in Canada,     methotrexate 50 mg/m2 intramuscularly (IM) followed three days later by 800 mcg vaginal     misoprostol to the Nigerian regimen of 400 mcg sublingual misoprostol with 400 mcg vaginal     misoprostol. The main outcome measure will be a completed abortion within the first week with     secondary outcome measures including total surgery rate, time to abortion, complications,     pain, side effects and patient satisfaction.      Rationale: If the investigators can find an inexpensive, easily available, method of medical     abortion, it will save many lives in third world countries.   "
174787|NCT00129519|"     The primary objective of this study is to assess whether basal cell carcinoma (BCC) lesions     surgically treated with curettage, followed by imiquimod 5% cream as postsurgical adjuvant     therapy, will have an improved cure rate over the ED/C historical norm of approximately 70%     at 1-year posttreatment follow-up. A secondary objective is to assess cosmetic outcome.   "
174788|NCT00129532|"     Heterosexual contact is now the primary route of transmission for HIV worldwide. This study     is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G     (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at     high risk.   "
174789|NCT00129545|"     This is a multi-center, prospective, randomized study, stratified by center, comparing the     WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is     non-inferior to the control arm. This study was amended to allow for a non-randomized arm and     increased enrollment.   "
174790|NCT00129558|"     This Phase I/II, multi-centered, non-randomized, trial is designed to determine a safe dose     of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as     therapy in subjects with refractory leukemia.   "
174791|NCT00129571|"     The purpose of this study is to assess the safety and tolerability of XL820 when given orally     to adults with advanced solid tumors.   "
174792|NCT00129584|"     The purpose of this study is to assess the safety and efficacy of the Emphasys Endobronchial     Valve (EBV) and procedure (with pulmonary rehabilitation) compared to optimal medical     management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.   "
174793|NCT00129597|"     Prevalence of chronic pain after mastectomy is beyond 50% 3 months after surgery. This pain     is related to a sensitization of the central nervous system through N-methyl-D-asparate     (NMDA) receptors. Ketalar might prevent the occurrence of chronic pain by anti-NMDA     properties after mastectomy.   "
174794|NCT00129610|"     The study aims at comparing virtual reality therapy (VRT) with a usual cognitive behavior     therapy (CBT) program for agoraphobia. A waiting list represents the control condition. The     investigators' purpose is to test a pure VRT compared with a pure CBT, as previous works     suggest that the combination of the two methods are clinically effective. Patients receive a     two-page information leaflet about the trial and sign an informed consent. After the first     evaluation, they are randomized, in three centers (Lyon, Paris, Luxemburg), either to VRT (12     sessions) or CBT (12 sessions), or a waiting-list control condition for three months. After     three months the waiting list is randomized to VRT or CBT. The follow-up is one year from     entry into the active part of the trial.   "
174795|NCT00129623|"     This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly     compared with placebo in post-menopausal women with osteopenia. Patients will be randomized     to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study     treatment is 1-2 years, and the target sample size is 100-500 individuals.   "
174796|NCT00129636|"     As part of the NHS plan it has been proposed to extend some consultants' usual practices and     to send all patients copies of the letters sent to their general practitioners (GPs)     following outpatient consultations. The current Secretary of State for Health has further     extended this proposal and suggested that patients should have a specific letter to     themselves after a hospital consultation.      The aim of this study is to send patients both a copy of the letter sent to their GPs and a     specific letter to themselves and to assess the usefulness and comprehensibility of each.   "
174797|NCT00129649|"     Many studies have shown a high non-attendance rate in hospital outpatient clinics. The     investigators have found a non-attendance rate of 25% in their asthma clinics and would like     to investigate whether a reminder phone call will improve attendance rates. Patients will be     randomised into two groups; one group will receive a reminder phone call one week prior to     their hospital consultation and the other group will be managed in the standard manner (i.e.     no reminder of any sort). The phone calls will be carried out on a Friday afternoon by a     respiratory nurse specialist and a research officer for two asthma clinics based on a     Wednesday morning and a Thursday afternoon.   "
174798|NCT00129662|"     Some five million people in the United Kingdom (U.K.) have asthma. The British Guidelines on     Asthma recommend self management education and the issuing of written personal asthma action     plans. The use of such self management education has been shown to be associated with an up     to 40% reduction in hospitalisation rates and a 20% reduction in Emergency Department     attendances and similar benefits in terms of symptoms and time off work. In asthma, the     results are best when the patients are provided with a personalised written action plan     explaining how to alter their medications according to a variety of circumstances. Chronic     obstructive pulmonary disease is a major cause of hospitalisation in the U.K. and is the     fourth biggest single cause of death. A recent Cochrane review regarding the value of self     management education in COPD has led to equivocal results although it has shown that those     with COPD are willing to take control of their own conditions. The reasons for the different     outcomes in asthma and COPD may reflect an inadequate number of trials of the wrong type;     interventions that were not appropriate or do not work; lack of the use of written action     plans; or assessment of benefit using the wrong outcomes.      Given the importance attached to the written action plan, it is essential that such advice is     available to all. However, studies of outpatients attending hospitals in the U.K. have shown     that 15% may be functionally illiterate and in studies of adults with asthma in the United     States (U.S.), 13% have similarly shown to be functionally illiterate. Pictorial advice may     therefore be advantageous and, when tested amongst those who are literate, it has been also     shown to enhance the recall of spoken medical instructions. The investigators have therefore     prepared some pictorial representations which are designed to give advice to those with     asthma and COPD about how to recognise the worsening of their conditions and what treatments     to alter or initiate as a result. The investigators now need to assess the comprehensibility     of those materials amongst a selection of patients with asthma and COPD.   "
174800|NCT00129688|"     Once-daily dose administration of aminoglycoside in adults is effective and economical.     However, its value in febrile neutropenic children, especially in Thailand, is less well     researched. In the area where Pseudomonas aeruginosa prevalence in febrile neutropenic     children is low, the combination of cloxacillin and amikacin is an appropriate approach. This     study would like to compare the efficacy and safety including cost between these two amikacin     administrations (once-daily or twice-daily) in combination with cloxacillin as an empirical     therapy in febrile neutropenic children.      Hypothesis: Once-daily amikacin plus cloxacillin can be used to treat febrile neutropenic     children in Khon Kaen, Thailand.   "
174801|NCT00129701|"     Consultation time in busy respiratory clinics is inevitably limited and attendance is often     disruptive to patients' lives; involves time, expense, travel, and waiting; and can have     effects upon occupation. Published work suggests that patient satisfaction with telephone     consultations is high and this subject has recently been extensively reviewed by one of the     study investigators. In respiratory medicine there is United States (US) data to suggest that     the regular telephoning of adolescents with asthma by a specialist nurse can reduce     unscheduled use of health service resources. In the United Kingdom (UK), a randomised,     controlled trial in primary care has shown that, compared to face to face consultations, use     of the telephone can enable greater numbers of patients with asthma to be reviewed. Another     of the study investigators has undertaken a feasibility study in a general respiratory clinic     and has shown the concept of alternating face to face consultation with telephone     consultation to be acceptable to over 80% of patients. Over one third were assessed to be     suitable in that they did not need to attend the clinic for either physical examination or     for investigations. It is therefore proposed to evaluate the feasibility, acceptability, time     savings and safety of the use of telephone consultation in 3 respiratory clinics in the     Department of Respiratory Medicine at Charing Cross Hospital.   "
174802|NCT00129714|"     The Westeinde Brachialgia Study (WEB) is a randomized controlled trial to establish the     effect of cervical collar or physiotherapy compared to a wait-and-see policy in patients with     acute cervical radiculopathy.   "
174803|NCT00129727|"     Study Design: This ia a Phase II study.      Subjects: Patients with chemotherapy naive epithelial ovarian cancer; or fallopian, primary     peritoneal and papillary serous mullerian tumors will be recruited.      Carboplatin and Taxol (paclitaxel) will be administered concurrently with bevacizumab after     surgery for 6-8 cycles every 21 (q21) days. Bevacizumab will be omitted in the first cycle,     immediately post-operatively. This will be followed by one year of bevacizumab q21.      Outcomes: Outcomes include toxicity, response rate, and progression free survival.   "
174805|NCT00129753|"     Primary Objective:      To determine the safety and efficacy of Campath-1H (Alemtuzumab) in patients with relapsed     and resistant classical Hodgkin's lymphoma.      Secondary Objectives:        1. To determine the duration of response and time to progression after Campath-1H therapy          in this patient population.        2. To determine the effect of Campath-1H on serum IL-6, IL-10, and IL-13 levels in patients          with relapsed and resistant classical Hodgkin's lymphoma.   "
174806|NCT00129766|"     The primary objective of this study was to compare the safety and efficacy of motavizumab to     palivizumab when administered monthly by intramuscular (IM) injection for the reduction of     the incidence of RSV hospitalization among children at high risk for serious RSV disease. A     secondary objective was to compare the incidence of medically-attended lower respiratory     infections (LRIs) between treatment groups.   "
174807|NCT00129779|"     Chronic obstructive pulmonary disease (COPD) is a term used for the conditions of chronic     bronchitis and emphysema, diseases that are very common among the elderly and diseases that     account for up to15% of all general medical admissions to National Health Service Hospitals.     In a recent report on emergency admissions to acute hospitals in London, the King's Fund     concluded that taking better care of elderly patients with COPD could reduce pressures on     acute hospitals, and suggested that identification of vulnerable patients with lung disease     and pro-active, rather than reactive, management might reduce the chances of     hospitalisation. In this study, the investigators wish to compare a group of patients with     COPD who are managed in the normal way, with another group of patients with COPD who receive     all interventions known to be of some benefit to those with this condition. This will include     a pulmonary rehabilitation programme, intensive education regarding self care, targeted     advice to their general practitioners regarding how best to manage COPD, and regular contact     with specialist respiratory nurses who will support the patients in their own homes by a     combination of home visits and telephone contact. The value of such a comprehensive     intervention will be studied, in terms of both its ability to reduce admissions to the     hospital and its impact on quality of life.   "
174808|NCT00129792|"     This study will determine the effects of a supplement in reducing symptoms of metabolic     syndrome, a collection of symptoms that increase the risk for developing heart disease,     stroke, and diabetes.   "
174809|NCT00129805|"     Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT)     levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic     peripheral arterial disease.      S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of     sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with     recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint     was recurrence of cerebral infarction; relative safety was also assessed.   "
174810|NCT00129818|"     The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day     (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with     and without a reported history of genital herpes and with or without herpes virus type 1     (HSV-1) seropositivity.   "
174811|NCT00129831|"     The purpose of this study is to determine the safety and tolerability of single doses of     QAB149 up to 3000 µg delivered via a single-dose, dry powder inhaler in patients with mild to     moderate COPD.   "
174812|NCT00129844|"     The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer     (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.   "
174820|NCT00129948|"     This is a phase 2, single-arm, open-label, multi-center study to establish the safety and     efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to     subjects with AML.   "
174813|NCT00129857|"     Each year a large number of patients are hospitalized at Shock Trauma Centers with severe     head injuries. Bleeding into and swelling of these patients' brains may cause compression of     vital structures, disability and death. Sometimes surgery is needed. Unfortunately, the     investigators have no medication to treat the bad effects of head trauma. Part of the brain     damage is due to toxic chemicals (including one called glutamate) that are released by the     damaged nerves. Dexanabinol may prevent some of the bad effects of glutamate on the brain and     may protect the brain against uncontrollable swelling and death.   "
174814|NCT00129870|"     The primary rationale for this study is to develop an optimized schedule of administration of     FOLFOX + bevacizumab that maximizes the efficacy and safety of this regimen when administered     to patients with advanced colorectal cancer. The hypothesis is that the use of an     intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow these patients to     continue on treatment for a longer period of time by reducing the proportion of patients who     discontinue therapy early because of treatment-related toxicities and thus increasing the     possibility of a longer time to progression.      The primary objective is:        -  To test the hypothesis that an intermittent oxaliplatin (IO) schedule of          FOLFOX/bevacizumab will allow patients to remain on therapy for a longer period of time          compared to a conventional treat-to-failure schedule, by reducing the proportion of          patients who discontinue therapy for treatment-related toxicities.      The secondary objectives are:        -  To evaluate the impact of calcium/magnesium infusions on the incidence and severity of          neurotoxicity in subjects receiving either the IO or conventional FOLFOX/bevacizumab          treatment schedules as first-line treatment for metastatic colorectal cancer.        -  To evaluate the safety and efficacy of the IO versus the conventional schedule + calcium          and magnesium infusions, as part of oxaliplatin-based first-line therapy for metastatic          colorectal cancer.   "
174815|NCT00129883|"     The purpose of this study is to test a strategy to improve the quality of antibiotic use in     lower respiratory tract infections (LRTIs) at hospitals. Therefore, a multifaceted     intervention strategy is compared to a control strategy and the effectiveness and feasibility     of the intervention is assessed.   "
174834|NCT00130143|"     Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a drug     approved to reduce the short and long-term occurrence of dry mouth when patients receive     radiation treatment for head and neck cancer. Some studies have shown that Amifostine reduces     the side effects of radiation treatment for lung cancer. The use of Amifostine is still being     investigated in lung malignancies. Amifostine is found to be a protectant from radiation side     effects of such normal tissues as bone marrow, skin, oral mucosal, esophagus, kidney and     testes. Patients that receive radiation treatments for lung cancer may experience side     effects involving the esophagus. It is hoped that patients will benefit from the protection     of their esophagus and avoid delays in radiation treatment due to side effects of the     radiation.   "
174816|NCT00129896|"     This is an open-label study to assess the efficacy and tolerability of the combination     Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients.     HER2 status will be confirmed centrally by fluorescence in situ hybridization (FISH).      Phase I: Initial doses will be:      Myocet: 50-60 mg/m² day 1 every 3 weeks; Taxotere 60-75 mg/m² day 1 every 3 weeks; and     Herceptin (4) 2 mg/kg weekly.      Sample size will depend on the number of patients recruited during dose escalation. Three     patients must be recruited in each dose level. If one out of three experiences a     dose-limiting toxicity (DLT), 3 more patients must be recruited in the same dose level.     Considering that there are 4 dose levels to be tested, the estimated number of patients is 9     to 24. Patients receiving the recommended dose (RD) will be incorporated into phase II of the     study.      Phase II: The average pathological complete response rate reported in other trials is around     11%. The investigators expect to achieve an increase of 14% on this rate; that is, they     expect a pathological response rate of 25%. With a= 0.05 and β=0.2, 18 patients are initially     needed. If at least 3 pathological complete responses are achieved, recruitment will continue     to up to 53 patients. At least 10 pathological complete responses are needed to probe the     hypothesis. Considering a 10% post-randomization drop-out rate, a total of 59 patients must     be recruited for the trial.   "
174817|NCT00129909|"     The objective of this study is to assess whether the implementation of a primary treatment     algorithm using a fixed dose combination therapy will improve the management of hypertension     when compared to usual management.   "
174818|NCT00129922|"     The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence.      Also, for axillary positive node patients, optimum chemotherapy regimens are still under     discussion. Some previous studies suggest that, in the subset of node-positive patients,     treatments based on sequential administration of anthracyclines and taxanes are more     efficient. Paclitaxel dose-dense (weekly) administration renders an improved therapeutic     index (activity/toxicity).      The study is designed to compare 6 courses of FEC scheme (600/90/600), a combination of     proven efficacy in node positive breast cancer patients, versus 4 FEC courses followed by 8     weekly paclitaxel administrations (100mg/m2).      The study hypothesis is that 5-year disease-free survival in the control arm will be 60%. The     investigators expect to increase this by 8% with the experimental treatment. With an alpha     error of 0.05, 80% power, and a post-randomization estimated drop-out rate of 10%, 1250     patients are needed, 625 per arm.   "
174819|NCT00129935|"     This is a prospective, randomised phase III trial, to compare the efficacy and safety     profiles of two types of adjuvant chemotherapy regimens for HER2 negative, node positive     breast cancer patients.      Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4     cycles of T 100 mg/m2 day 1 every 3 weeks.      Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by     4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a     one-week rest period.      Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen     after the end of chemotherapy.      Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or     aromatase inhibitors (or both) after the end of chemotherapy.      Patients may receive radiotherapy when clinically indicated. Estimation of the 5-year     disease-free survival in the control arm is 72%. The experimental arm is expected to increase     the 5-year disease-free survival by 7% (up to 79%). With an alpha error of 0.05 and 80%     power, 592 patients per arm are needed. Assuming a 17% post-randomization drop-out, 691     patients per arm are needed.   "
174822|NCT00129974|"     The purpose of the study is to determine whether pemetrexed and gemcitabine cause good tumour     shrinkage when given to patients with previously untreated extensive-stage small cell lung     cancer. The second purpose is to see if the side effects appear better than what is expected     with standard chemotherapy.   "
174823|NCT00129987|"     Long term conditions often necessitate long term care. In many cases, giving control of their     conditions to the patients themselves produces the best outcomes. Such patient education and     the acquisition of self-management skills can be time consuming and the evidence suggests     that the process is often not undertaken by doctors. Sometimes it is delegated to nursing     colleagues, but all health professionals are in short supply. Patients carry credibility as a     resource and this project is designed to determine, by means of a multi-centre randomised     controlled trial, whether well trained lay educators can deliver training in self-management     education to others with asthma, with outcomes equivalent to those achievable by a nurse.   "
174835|NCT00130156|"     The purpose of this study is to investigate the efficacy and safety of Bunazosin with     Valsartin compared to Doxazosin with Valsartin for patients with mild to moderate essential     hypertension accompanied by metabolic syndrome.   "
174836|NCT00130169|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974     administered on Days 1 and 15 of a 28-day cycle in subjects with solid malignancies that have     progressed following effective therapy or for which no effective therapy exists.   "
174837|NCT00130182|"     The purpose of this study is to investigate the safety and effectiveness of two dose     strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).   "
174838|NCT00130195|"     The purpose of this study is to determine the clinical efficacy and safety of     imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.   "
174839|NCT00130208|"     The purpose of the study is to determine whether treatment with sulodexide is effective in     reducing the level of urine albumin excretion in patients with early diabetic kidney disease     expressed as microalbuminuria.   "
174868|NCT00130585|"     The main objectives of this project are:        1. to determine the relative bioavailability of dietary folate from a total diet, compared          with synthetic folic acid and        2. to determine the bioavailability with a higher precision than previous methods.      The hypothesis is that the bioavailability of dietary folate within a confidence interval of     +/-20% can be estimated.   "
174824|NCT00130000|"     This study will evaluate the safety and effectiveness of the experimental drug eculizumab for     treating paroxysmal nocturnal hemoglobinuria (PNH), a disorder that can cause premature     destruction of red blood cells. PNH may result in anemia requiring blood transfusions.     Patients may be at high risk of life-threatening blood clots in their veins and may have     urine discoloration, stomach pain, difficulty swallowing, tiredness, and poor quality of     life. Men may have problems getting or maintaining an erection. Eculizumab is a monoclonal     antibody that may improve the survival of red blood cells in patients with PNH.      Patients 18 years of age and older who have been diagnosed with PNH for more than 6 months,     who have active disease, and who require blood transfusions may be eligible for this study.     Each candidate is screened with a physical examination, electrocardiogram, blood and urine     tests, and a questionnaire for information on how PNH affects the patient physically,     socially, emotionally, and functionally.      Participants receive infusions of eculizumab through a needle in a vein once a week for five     doses and then every two weeks for another 24 doses. All patients are vaccinated against     Neisseria meningitides, a bacteria that can cause symptoms, possibly including     life-threatening meningitis, in susceptible people, including people who take eculizumab.      At every treatment visit, patients update their health status, transfusion record, and     medication use; review their laboratory results from the preceding visit; have vital signs     measured; and provide a blood sample for laboratory tests. At selected visits, they also     provide a urine sample, have a repeat electrocardiogram, and complete a questionnaire. At the     final treatment visit, participants have a complete physical examination, in addition to the     routine procedures.   "
174825|NCT00130013|"     The World Health Organization’s (WHO) standard case management strategy for reducing acute     respiratory infection (ARI) related mortality recommends oral cotrimoxazole and oral     amoxicillin as first line drugs for the treatment of pneumonia. In 1989, the Pakistan     Ministry of Health (MOH) adopted this strategy to control ARI mortality and recommended     cotrimoxazole for treatment of outpatients pneumonia due to lower costs. A number of studies     subsequently performed have shown significant in vivo and in vitro resistance of H.     influenzae and S. pneumoniae, the commonest bacteria causing childhood pneumonia, to     cotrimoxazole.      Although on a case by case basis for pneumonia, in vitro resistance does not correlate very     well with in vivo failures, nevertheless, clinical failure rate for pneumonia therapy has     increased in Pakistan over the years. One can hypothesize that if bacterial pneumonia is a     certain proportion of all pneumonia cases, the rise in clinical failures may be related to     increasing antimicrobial resistance. Therefore, it is probable that this rising clinical     failure rate could be a reflection of increasing resistance. There may be an increase in     antimicrobial resistance of S. pneumoniae and H. influenzae to amoxicillin over the period of     years and the rising treatment failure could be a reflection of the rising minimum inhibitory     concentrations (MIC’s) (> 2 mcg/ml for H. influenzae, 1993-94), thereby, resulting in this     increasing failure rate.      For the current study the researchers propose a multicentre, randomized, controlled double     blind trial in which standard versus double dose oral amoxicillin for three days for the     treatment of non-severe pneumonia in children less than five years of age will be compared.      Primary Objective:      To compare the proportion of children 2 – 59 months of age presenting with non-severe     pneumonia, who achieve clinical resolution on day 5 with standard (15 mg/kg/8hrly) versus     double dose (30 mg/kg/8hrly) of oral amoxicillin therapy given for 3 days.      Secondary Objective:      To follow the clinical course of non-severe pneumonia with the alternative criteria of     treatment failure (signs of deterioration i.e. lower chest indrawing and appearance of danger     signs) on or before day 3 and compare them with other children who have persistent fast     breathing (respiratory rate above the cut off for age) on day 3.      Hypothesis:      Therapy outcome with double dose of oral amoxicillin is not different than the standard dose     of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2–59     months old children.   "
174826|NCT00130026|"     The objective of this study is to determine if caffeine 500 mg intravenously is efficacious     when added to standard anti-emetic prophylaxis in the prevention of post-operative nausea and     vomiting (PONV) in patients undergoing ambulatory surgery under general anesthesia.   "
174827|NCT00130039|"     This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1     segment of Middle cerebral artery (MCA) or basilar artery).      They will be randomly assigned into cilostazol group or clopidogrel group. Every patients     will take 100mg of aspirin a day additionally.      The primary outcome variable of this study is Progression rate of symptomatic intracranial     stenosis on magnetic resonance angiogram (MRA).   "
174828|NCT00130065|"     The purpose of this study is to determine whether folic acid, which is often routinely given     to pregnant women to prevent birth defects and anemia, affects the efficacy of     sulfadoxine-pyrimethamine, another drug that is routinely given to pregnant women in highly     malarious areas, for prevention of the adverse effects of malaria during pregnancy.   "
174829|NCT00130078|"     Heterosexual contact is now the primary route of transmission for HIV worldwide. This study     is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G     (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at     high risk.   "
174830|NCT00130091|"     The current study will compare the effects on postoperative pain relief of freezing     (ropivacaine 0.2 %) alone and in combination with clonidine for a nerve block in children     undergoing hernia repair. The researchers anticipate that the addition of clonidine to     freezing will result in prolongation of postoperative pain relief in children undergoing     hernia repair compared to freezing used alone.   "
174831|NCT00130104|"     The purpose of this study is to determine if the transthecal metacarpal block is superior to     the traditional digital block for regional digital anesthesia in children.   "
174832|NCT00130117|"     The purpose of this study is to determine whether administration of an investigational     medication called leptin (r-metHuLeptin) in replacement doses can improve bone health,     reproductive function, hormone levels, immune function, and overall sense of well-being in     women with hypothalamic (exercise-induced) amenorrhea (HA) who are being treated with oral     contraceptive pills (OCPs), compared to placebo. Women with hypothalamic amenorrhea have low     leptin levels. This study is based on the hypothesis that the relative leptin deficiency in     women with hypothalamic (exercise-induced) amenorrhea may be the reason for the lack of     menstrual cycles, hormone abnormalities, and bone loss associated with this condition.   "
174833|NCT00130130|"     The overall purpose of this project is to improve nurse skills regarding neuropathic pain     (NP) assessment, treatment and referral practices through implementation of an evidence-based     algorithm and to improve selected patient outcomes as a result of algorithm use.   "
174856|NCT00130429|"     The purpose of this study is to assess the effect of PYM50028 administered once daily for up     to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's     disease.   "
174857|NCT00130442|"     The aim of the study is to compare the safety and effectiveness of a new drug called PI-88,     when used in combination with an approved chemotherapy drug called dacarbazine, in the     treatment of metastatic melanoma.      PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbazine     stops the cancer cells from growing. The results from this study will be analysed to see if     it is worthwhile for the two drugs to be tested in future studies involving larger numbers of     melanoma patients.   "
174840|NCT00130221|"     Patients in the intensive care unit are at risk for many infections because the severity of     illness and the procedures necessary to care for them. This study is designed to look at a     change in bathing procedure as a method to reduce infections. Currently, patients at John H.     Stroger Hospital are cleansed with soap and water. However, preliminary data from a previous     study at Rush University Medical Center showed that a chlorhexidine (CHG)-impregnated cloth     (2% CHG Antiseptic Cloth system, Sage Products, Inc.) decreased skin bacteria and may lessen     bacteria in the blood stream. The 2% CHG Antiseptic Cloth system is a non-irritating,     no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. The     goal of this proposed study is to further evaluate the effectiveness of the 2% CHG Antiseptic     Cloth system compared with soap and water in cleansing the skin and preventing bacteria from     entering the bloodstream.   "
174841|NCT00130234|"     This study is being done to find out if a drug called Xolair (omalizumab), an anti-IgE     antibody, is safe and effective for people with chronic urticaria (hives) with persistent     symptoms in spite of taking antihistamines.   "
174842|NCT00130247|"     Tuberculosis (TB) is a serious infection that can affect the lungs and other parts of the     body. The usual way to treat TB is to take 4 medicines by mouth every day for 2 months, then     take 2 of the same medicines for 4 more months, for a total of 6 months. The purpose of this     study is to see if taking 4 months of TB medicines is as effective in curing some TB patients     as taking 6 months of TB medicines. Study participants will include 758 human     immunodeficiency virus (HIV)-non-infected individuals, ages 18-60. Participants will be     treated with 4 standard drugs called isoniazid, rifampicin, pyrazinamide and ethambutol. All     individuals will take TB medicines for at least 4 months. After 4 months of treatment, if no     TB germs are growing in sputum samples, participants will be assigned to either stop taking     TB medicine (4 months of treatment) or to continue taking TB drugs for 2 more months (6     months of treatment). Participants will be involved in study procedures for up to 30 months.   "
174843|NCT00130260|"     This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus     aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease     patients, by giving a 3rd and 4th dose to a subset of the participants in the previous     efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner,     and are also randomly assigned to 1 of 2 different intervals between the doses. The     immunogenicity is measured by the antibodies in the blood, and typical vaccine safety     information is also collected.   "
174844|NCT00130273|"     This study will determine whether a managed problem solving intervention can help patients     with HIV better follow their anti-HIV drug regimen and can control HIV better than the     standard of care.   "
174845|NCT00130286|"     The purpose of the study is to determine if the combination of recombinant human growth     hormone plus rosiglitazone (an insulin-sensitizing drug) is safe and more effective than     either drug alone (or no active therapy) for the treatment of fat accumulation in people with     HIV infection and insulin resistance.   "
174846|NCT00130299|"     The primary aim of this study is to compare the effects of an experimental low-glycemic load     diet with those of a conventional low-fat diet among obese young adults in an 18-month     randomized-controlled trial.   "
174847|NCT00130312|"     The purpose of this study is to determine whether sulodexide is effective in slowing or     preventing the progression of diabetic kidney disease.   "
174848|NCT00130325|"     There are new TB vaccines already developed that need to be tried in humans to assess their     efficacy.      The researchers had previously shown that production of interferon gamma by T cells in     response to TB antigens is a more specific marker of TB infection.      The researchers hypothesize that this can be used as a reliable early marker of TB vaccine     efficacy. The researchers expect to show a significantly increased reversion of this test in     household contacts of TB patients given Isoniazid prophylaxis treatment for 6 months.   "
174851|NCT00130364|"     This study is not being conducted in the United States of America (USA).      Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin     elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell     activation. These cells are involved in the inflammatory component of the disease. This study     will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face     in patients intolerant of, or dependent on, topical corticosteroids.   "
174852|NCT00130377|"     This is the clinical registry of cell based therapies that is available to researchers around     the world. The registry is web based. All researches must provide IRB approval to the     coordinating site- University of Utah in order to obtain access to the registry. The are     predetermined case report forms for cardiovascular diseases that are currently in clinical     trials- including demographics, safety, and possible efficacy end-points. All investigators     have access to their own data. The servers are U.S. HIPPA compliant and protected with secure     back-up.   "
174853|NCT00130390|"     The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide     compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohn's     disease in adults.   "
174854|NCT00130403|"     To determine how prior therapy with alendronate or risedronate in postmenopausal women with     osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of     the study is to compare the teriparatide (human, recombinant PTH[1-34])-associated change     from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP),     between subjects previously treated with risedronate and those previously treated with     alendronate.   "
174855|NCT00130416|"     The overall goal of this randomized, controlled trial is to test whether educational     interventions - directed toward empowering patients and delivered via the Beth Israel     Deaconess Medical Center (BIDMC's) secure patient Internet portal PatientSite - can improve     the outcomes and satisfaction with care of adult primary care patients with 3 common     conditions: chronic pain, depression, and progressive difficulty walking.   "
174858|NCT00130455|"     The study is designed to establish the efficacy and tolerability of escitalopram in the     treatment of depressive episodes of mild to moderate severity in the elderly.      The study is designed as a mainly naturalistic study including all patients of 65 years of     age or above that judged by the clinician would benefit from treatment by an antidepressant     medication. The study is designed as a double-blind, randomised placebo controlled study with     two groups of active treatment (escitalopram in two doses, 5 or 10 mg daily) in a twelve week     period.   "
174859|NCT00130468|"     This study will evaluate the efficacy and safety of intra-articular injections of 20 mg/2mL     dose HYALGAN in patients with pain due to osteoarthritis (OA) of the knee.   "
174860|NCT00130481|"     The purpose of this study is to determine if Atorvastatin can improve blood vessel stiffness     and blood vessel function in children 10-18 years old with Type 1 and Type 2 diabetes.     Subjects will receive atorvastatin 20mg or placebo daily for 3 months and will then switch     therapies for the next 3 months.      Hypothesis: Atorvastatin will improve blood vessel function by decreasing arterial stiffness     and improving blood flow.   "
174861|NCT00130494|"     This is an open-label, randomized, multicenter phase III trial to assess the efficacy of     early administration of zoledronate versus observation in delaying bone-related symptoms in     metastatic breast cancer patients.      Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation     until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per     treatment arm will be enrolled in the study.      Once bone-related symptoms appear, study participation is over. During the study, the     following will be assessed:        -  quality of life,        -  performance status,        -  pain rating,        -  analgesic administration and        -  adverse events The principal objective is the delay in bone-related symptoms in those          patients with early zoledronate administration.   "
174862|NCT00130507|"     Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab,     until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks.     HER2 status must be locally assessed by immunohistochemistry (IHC). All 3+ patients are     eligible. In 2+ patients, HER2 status must be confirmed by fluorescence in situ hybridization     (FISH).      Principal outcome is clinical benefit (complete + partial responses + stable disease). Sample     size in each arm has been estimated with the Fleming method. Previous data show a clinical     benefit rate of vinorelbine plus capecitabine around 50%. The researchers assume trastuzumab     can increase it by 20%. With an alpha error of 0.05 and 80% power, 37 patients per arm are     needed.      This is a randomised phase II trial. With a minimum expected benefit rate of 50%, at least 36     patients are needed to choose, with a 90% of probability to be right, the best treatment arm,     providing it increases benefit rate at least by 15%.      Assuming a drop-out rate of 10%, the total number of patients needed is 82, 41 per treatment     arm.      Patients will be stratified as per investigational site, and presence of visceral metastatic     lesion (liver, lung, pleura, heart, peritoneum, suprarenal glands). All patients must receive     2 cycles. If no disease progression is detected, treatment must continue until progression or     unbearable toxicity.   "
174863|NCT00130520|"     The purpose of this project is to determine if a new combination of drugs, erlotinib     (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian     cancer whose cancer has progressed while on prior standard chemotherapy treatment with a     taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).   "
174874|NCT00130663|"     This study will look at general pediatricians' effectiveness at screening children for     elevated blood pressure values in the primary care setting. Two new screening tools will be     introduced and their effectiveness will be measured against current practice by way of     medical chart review.   "
174891|NCT00130884|"     The study will investigate the efficacy of oral levosimendan in patients with chronic New     York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point     evaluating patient symptoms, morbidity and mortality. The patients are on treatment for at     least 6 months.   "
174892|NCT00130897|"     The primary objective of this protocol is to provide access to SU011248 treatment for     patients with metastatic RCC who are ineligible for participation in ongoing SU011248     clinical studies and have the potential to derive clinical benefit from treatment with     SU011248 based on the judgment of the investigator.   "
174864|NCT00130533|"     This is a prospective, open-label, randomized phase III study. Patients will be stratified as     per investigational site, previous adjuvant chemotherapy (anthracyclines versus     anthracyclines plus taxanes), and number of affected axillary lymph nodes (0, 1-3, >= 4).     Node negative patients must present a tumour size > 2 cm to be eligible. At least 6 lymph     nodes must be analysed to confirm the number of affected nodes. Patients will be randomised     to receive: 8 courses of capecitabine 1000 mg/m2 by mouth, twice a day (p.o. bid) for 14     days, followed by a 7 day rest versus observation.      Tissue samples must be analysed by a central laboratory, to confirm estrogen receptor (ER),     progesterone receptor (PgR), human epidermal growth factor receptor-2 (HER2), cytokeratins CK     5/6 and epidermal growth factor receptor (EGFR) status.      The following data were obtained from the database of the El Alamo project. One thousand     six hundred and twenty-seven (1,627) in total were considered during the years 1990 to 1997.     The population is formed of patients with operable breast cancer, with surgery, positive     nodes, and negative hormone receptors, or negative nodes, negative hormone receptors and T2-3     tumors.      For these patient groups, estimated 5-year disease-free survival is 64.72%. Assuming an     exponential distribution, the aim is to detect an increase of 64.72% to 73.7% in 5 years     Disease Free survival rate corresponds to a Hazard Ratio of 0.701 and a risk reduction of     about 30%, with a power of 80% using a two-tailed log-rank test at 0.05 and whereas 4 years     of recruitment period and 3 years of follow-up period. We would need 255 events, 834 patients     without considering any dropouts.      Considering a drop-out rate of 5% post-randomization, the final sample size will be 876     patients, 438 per treatment arm.      The sample size calculation was performed by the program package EAST version 5.2.   "
174865|NCT00130546|"     The main objective of this study is to assess the safety and effectiveness of the Sirolimus     eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native     coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting     with two or more coronary artery stenoses (prospective, randomized, intra-individual     comparison).   "
174866|NCT00130559|"     Heart failure is a common reason for respiratory failure in ICU patients. The rapid and     accurate differentiation of heart failure from other causes of respiratory failure remains a     clinical challenge. BNP levels are significantly higher in patients with congestive heart     failure as compared to patients with respiratory failure due to other causes. Therefore,     rapid measurement of BNP might be very helpful in establishing or excluding the diagnosis of     heart failure in patients with respiratory failure in the ICU.      The aim is to test the hypothesis that a BNP guided diagnostic strategy would improve the     evaluation and management of patients presenting with primary (on admission) or secondary     (while in the ICU) respiratory failure in the ICU and thereby reduce total treatment time and     total cost of treatment.      Primary endpoints are time to discharge and total cost of treatment. Secondary endpoints are     ICU length of stay, ICU cost, in-hospital mortality, 30-day mortality, cost-effectiveness, 6     and 12 month mortality, 6 and 12 month dyspnea score.   "
174867|NCT00130572|"     The purpose of this study is to investigate whether topical applied pimecrolimus will lead to     improvement of erosive oral lichen planus. This effect will be monitored by reduction of     erosive mucosal area and reduction of patient's pain symptoms.   "
175069|NCT00133302|"     The purpose of this trial is to investigate the clinical benefit of the dose intensified     regimen, Bi-CHOP in comparison to standard CHOP for advanced intermediate or high grade     non-Hodgkin's lymphoma (NHL).   "
174869|NCT00130598|"     Contrast nephropathy (CN) remains a common complication of radiographic procedures and an     important cause of hospital-acquired acute renal failure. Only hydration with saline is     uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN.     But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even     more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim     of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with     a prolonged infusion of sodium chloride in the prevention of CN.      Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.   "
174870|NCT00130611|"     Cost-effective management of heart failure and pulmonary disease is of paramount importance.     Unfortunately, the rapid and accurate differentiation of heart failure from other causes of     dyspnea in private practice is challenging. B-type natriuretic peptide (BNP) levels are     significantly higher in patients with congestive heart failure as compared to patients with     dyspnea due to other causes. As a simple, non-expensive assay easily applicable in private     practice is available, rapid measurement of BNP might be very helpful in establishing or     excluding the diagnosis of heart failure in patients presenting with acute dyspnea in private     practice.      The aim is to test the hypothesis that a BNP guided diagnostic strategy would improve the     evaluation and management of patients presenting with acute dyspnea to physicians in private     practice and thereby reduce total cost of diagnosis and treatment.      The primary endpoint is total medical cost within 3 months.   "
174871|NCT00130624|"     The study aims to determine whether multidisciplinary assessment of community-based patients,     who have had at least one previous fall, reduces the rate of further falls and fall-related     problems. The study also aims to determine whether such an intervention, if effective, is     best carried out in a primary or secondary care setting.   "
174872|NCT00130637|"     This study will examine the safety and effectiveness of a monoclonal antibody called     humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with     uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis     (JIA). Monoclonal antibodies are genetically engineered proteins made in large quantities and     directed against a specific target in the body. The HAT antibody is designed to prevent a     specific chemical interaction needed for immune cells to produce inflammation. Current     treatments for uveitis include steroids and immune-suppressing drugs. These treatments do not     always work or they may cause significant side effects. This study will determine whether     daclizumab can improve uveitis in children and reduce the need for other medicines.      Patients between 6 and 18 years of age with active non-infectious JIA-associated uveitis     requiring treatment with anti-inflammatory medications as often as three times a day or more     may be eligible for this study.      Each candidate is screened with a medical history, physical examination, blood tests, eye     examination, and the following specialized tests:        -  Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected          into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina          are taken using a camera that flashes a blue light into the eye. The pictures show if          any dye has leaked from the vessels into the retina, indicating the presence of          inflammation.        -  Optical coherence tomography to measure retinal thickness. The eyes are examined through          a machine that produces cross-sectional pictures of the retina. These measures are          repeated during the study to determine changes, if any, in retinal thickening.        -  Stereoscopic color fundus photography to examine the back of the eye. The pupils are          dilated with eye drops to examine and photograph the back of the eye.      Upon entering the study, participants receive a 90-minute infusion of daclizumab through a     catheter (plastic tube) placed in an arm vein. They return to the clinic after 14 days and     again after 28 days for repeat eye examinations, blood tests, and daclizumab infusions. Four     weeks after the third infusion, patients are examined for response to treatment. Those who     have benefited from daclizumab may continue receiving monthly infusions of the drug for up to     one year. A blood test and eye examination are done at the time of each infusion. Patients     whose disease has remained active 12 weeks after the first infusion are taken off the study     and treated with other medications.   "
174875|NCT00130676|"     Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called     cortisol. Under normal conditions, cortisol and other hormones are created by the body in     response to physical and emotional stress, triggering a healthy stress response. People who     suffer from psychotic major depression may have unusually high levels of cortisol circulating     within them or abnormal patterns of cortisol levels, overloading the stress response     mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If     Corlux can keep the body's cortisol receptors from being overloaded, the stress response     system may return to normal function, which may result in improvement of symptoms. The     purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients     who have been diagnosed with psychotic major depression (PMD).   "
174876|NCT00130689|"     Purpose: There remains a great need for novel therapeutic agents and treatment strategies for     advanced esophagogastric cancer. Preclinical and clinical studies have demonstrated increased     EGFR expression in a significant proportion of both esophageal and gastric carcinomas.     Inactivation of EGFR through use of a monoclonal antibody in preclinical models has resulted     in inhibition of tumor growth. Agents designed to block the EGFR pathway have demonstrated     disease control among previously treated patients with metastatic esophageal and gastric     cancer. The proposed mechanism of action for cetuximab is its ability to effectively disrupt     EGFR-mediated signal transduction pathways that ultimately leads to halting cell cycle     progression, induces apoptosis, and also inhibits processes important for tumor growth, such     as cell invasion and angiogenesis.   "
174877|NCT00130702|"     The purpose of this study is to determine how effective, and to what extent, Iressa is in the     treatment of acute myelogenous leukemia.   "
174878|NCT00130715|"     The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence     of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs)     associated with the use of Seprafilm occurring within 30 days postoperatively, and the     incidence of abdominopelvic abscess within 6 months postoperatively.   "
174879|NCT00130728|"     This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study.     Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.   "
174880|NCT00130741|"     This is an 8-week double-blind, placebo-controlled, randomized, parallel-group study with an     additional two week baseline observation period to evaluate the safety of combination herbal     therapy (CHT) versus placebo and short and long-term efficacy in terms of improved IBS,     overall quality of life (QOL) and symptomatology.   "
174881|NCT00130754|"     Allogeneic stem cell transplantation is the treatment of choice for a growing number of     malignant and non-malignant indications. Until recently, myeloablative in conjunction with     immunosuppressive conditioning was considered mandatory for the elimination of malignant     hematopoietic cells and to prevent graft rejection. The aim of allogeneic non-myeloablative     stem cell transplantation (NST) is to induce host-to-graft tolerance with fast and durable     engraftment of donor stem cells, by means of conditioning, which is well-tolerated by     patients. The rationale behind the NST strategy is to induce optimal graft-versus-leukemia     (GVL) effects for the elimination of all malignant cells by alloreactive immunocompetent     cells from a matched donor as an alternative to standard high-dose myeloablative chemo     radiotherapy. The NST protocol is therefore mainly based on immunosuppression and thus     contains fludarabine, low dose busulfan and anti-T-lymphocyte globulin (ATG). Thymoglobuline     is a polyclonal rabbit antiserum specific for human T cells used in organ transplantation for     induction of tolerance and rejection prevention and treatment. It was also used in stem-cell     transplantation (SCT) for the same purposes (e.g. for generation of tolerance and rejection     preclusion) as well as a treatment for graft-versus-host disease (GVHD). Data from     myeloablative protocols suggest that ATG before SCT significantly reduces the risk for grade     III-IV acute GVHD. This does not translate to a reduction in transplant-related mortality     (TRM) because of the increased risk for infections and thus survival is unchanged. Extensive     chronic GVHD was also significantly shown to be reduced in patients receiving ATG in the     myeloablative setting. However, the role of ATG in the NST protocol was never evaluated in a     prospective randomized trial. In view of the preliminary data suggesting of an additive     effect of ATG in these circumstances we, the investigators at Hadassah Medical Organization,     evaluate the effect of ATG in NST by a prospective randomized trial.   "
174882|NCT00130767|"     The aim of this study is to evaluate the mechanisms involved in the apoptosis induced by a     treatment of finasteride on benign prostate hyperplasia (BPH). Five sets of patients who need     a surgical procedure because of low tract urinary symptoms are randomly attributed to one of     five sets of treatment: 0, 7, 14, 21 or 28 days of finasteride treatment before the day of     the procedure. Prostate histological fragments are conditioned for molecular and histologic     studies.   "
174883|NCT00130780|"     This is a phase II, single institution trial for patients with clinical Stage IB-IIIA NSCLC     (T1-3N0-2M0) who have resectable lung tumors. The primary goal of this study is to show that     the addition of bevacizumab to a cisplatin-based chemotherapy in the neoadjuvant setting for     non-squamous cell carcinomas improves the rate of pathologic downstaging, which correlates     with survival. Downstaging is defined as any decrease in the final pathologic stage compared     with the clinical stage before induction therapy.   "
174884|NCT00130793|"     The purpose of this study is to determine whether the refrigerator-stable formulation of an     investigational vaccine has a comparable immune response (the body's ability to protect     against disease) and safety profile to that of the freezer-stable formulation of the vaccine.   "
174885|NCT00130806|"     This is a study to evaluate the effectiveness and tolerability of an investigational drug in     patients with type 2 diabetes (a specific type of diabetes) who are not currently treated     with insulin.   "
174886|NCT00130819|"     The purpose of this study is to compare the effectiveness of two approaches to treating     HIV-infected patients who are addicted to opioid drugs (e.g., heroin) in an inner-city HIV     clinic. The two approaches are:        -  Case management and referral - participants are managed by a case manager and referred          to a specialized drug treatment center where they receive counseling and medications for          opioid-dependence (e.g., methadone or buprenorphine); or        -  Clinic-based treatment - participants receive counseling and treatment with          buprenorphine at the HIV clinic.   "
174887|NCT00130832|"     The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to     rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing     the safety or immunogenicity of either vaccine.   "
174888|NCT00130845|"     The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in     approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening     diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce     the development and progression of diabetic retinopathy, intensive control of glucose is     usually not achieved in clinical practice.   "
174889|NCT00130858|"     Phase II Study to evaluate the response on two blocks of topotecan and carboplatin   "
174893|NCT00130910|"     Identifying methods to slow disease progression in patients with HIV-1 infection remains a     top priority in many regions of the world. In many countries, medications known to slow     progression are not readily affordable or available. Many of the individuals living in these     countries are also co-infected with a variety of other diseases such as tuberculosis, malaria     and soil-transmitted helminths. There are data to suggest that infection with these agents     may activate the immune system in HIV-1 co-infected individuals and may lead to more rapid     HIV disease progression. This study will evaluate the potential impact of treating helminths     in HIV-1 seropositive individuals. Markers of disease progression and immune activation will     be assessed. We will also measure the amount of virus in genital secretions to determine if     treatment of co-infection can reduce the infectiousness of HIV in these individuals.   "
174894|NCT00130923|"     The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to     risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with     schizophrenia or schizoaffective disorder.   "
174911|NCT00131144|"     The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in     approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening     diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce     the development and progression of diabetic retinopathy, intensive control of glucose is     usually not achieved in clinical practice.   "
174927|NCT00131352|"     This clinical study is to evaluate the safety and efficacy of hylan G-F 20 (Synvisc) in     patients with symptomatic knee osteoarthritis (OA). Patients will be given 6 mL of hylan G-F     20 (Synvisc) (or a phosphate buffered saline control), with a possible repeat treatment with     Synvisc after the week 26 visit.   "
174895|NCT00130936|"     Although declining in incidence, gastric/gastroesophageal cancer is still a commonly     diagnosed malignancy in Canada. Patients who have undergone surgical resection for early     disease have a high rate of local recurrence and distant spread. More than 50% of patients     present with either locally advanced or metastatic disease. Patients with advanced disease     have an extremely poor prognosis, with average survival times ranging from 3 - 9 months.     Development of new therapeutic approaches for locally advanced or metastatic     gastric/gastroesophageal cancer, is clearly needed.      Despite its proven efficacy, ECF (epirubicin, cisplatin, and infusional 5-fluorouracil     [5-FU]) has not been widely adopted in North America and is likely due to the technical     difficulties and inconvenience associated with infusional chemotherapy. This study will     substitute the oral chemotherapy drug capecitabine for infusional 5-FU in addition to     substituting intravenous cisplatin with carboplatin (ECC - epirubicin, carboplatin and     capecitabine). It is hoped that these substitutions will not only reduce the typical ECF     related adverse effects but also allow for a more convenient administration of outpatient     chemotherapy. It is also hoped that the genetic correlates of this study may also identify     specific populations that preferentially benefit from ECC treatment.   "
174896|NCT00130949|"     Tennis elbow is a painful condition that results from repetitive arm movement with overuse of     muscles, e.g. when playing tennis. A single injection of ALGRX 4975 has the potential to     reduce pain for a period of weeks to months. This study will test the efficacy and safety of     ALGRX 4975 in the treatment of patients with tennis elbow.   "
174897|NCT00130962|"     Subjects will have painful primary or post-operative intermetatarsal neuroma. Study drug or     placebo will be injected into the space containing the neuroma. Subjects will complete weekly     assessments for severity of foot pain, a brief pain inventory, and the amount of pain     medication taken. Subjects will be seen for a screening visit, a treatment visit, and two     follow-up visits after treatment. The last scheduled visit is one month after treatment. Some     subjects may be followed by monthly telephone interviews to assess their level of pain over     the six-month period following treatment.   "
174898|NCT00130975|"     The purpose of this study is to test the hypothesis that treatment with the angiotensin II     type 1 receptor antagonist candesartan may reduce the recurrence rate of atrial fibrillation     after electrical cardioversion.   "
174899|NCT00130988|"     General practitioners play a key role in the management of one of the most complex problems     facing the health care system: the large group of patients with unexplained medical symptoms,     but effective treatment strategies are lacking in primary care. The purpose of this study is     to compare a new intervention delivered by the general practitioner versus re-attribution of     symptoms, which is the currently recommended best treatment for patients with high levels of     medically unexplained physical symptoms.   "
174900|NCT00131001|"     PURPOSE: The purpose of this clinical trial is to study the cost-effectiveness ratios of     diagnostic strategies for the imaging assessment of symptomatic carotid stenosis.      MATERIALS AND METHODS: The diagnostic accuracies of Doppler ultrasound (DUS),     contrast-enhanced magnetic resonance angiography (CEMRA) and computed tomography angiography     (CTA) were compared with digital subtraction angiography (DSA) in a multicenter study     (CARMEDAS; 206 patients assessable) and in a meta-analysis (for CEMRA and CTA). The direct     costs of each imaging method were calculated in 2 university medical centers. Eight     hypothetical models were studied with DUS considered as the first-line imaging method and     either CEMRA or CTA or DSA as the second or third line method. The effectiveness criterion     was the number of potential avoided strokes for each strategy and for 1000 patients.   "
174901|NCT00131014|"     The purpose of this study is to investigate possible genetic factors that contribute to the     development of lymphomas. The databank will be used to determine whether familial lymphomas     have unique genetic characteristics different from sporadic lymphomas and to attempt to     identify a gene that confers an increased risk of lymphoma.   "
174902|NCT00131027|"     The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate     consolidation therapy for adult patients with BCR-ABL-negative ALL.   "
174903|NCT00131040|"     The purpose of this study was to see if the heart-lung machine involved in cardiac surgery     increases the movement of activated white blood cells from the bloodstream into the patient's     tissues and also to see if aprotinin usage during surgery reduces this effect.   "
174904|NCT00131053|"     The purpose of this study is to investigate the efficacy and safety for treating adult ALL     patients with the pediatric protocol.   "
174905|NCT00131066|"     The purpose of this study is to evaluate the long-term safety and profile of psoriasis     patients who have completed participation in a previous study and who received treatment with     MEDI-507.   "
174906|NCT00131079|"     The potential health gains from active lifestyles are very well-known and it is recommended     that all adults dedicate at least 30 minutes to activities of at least moderate intensity at     least five days a week. What is still not known is how to help sedentary people follow this     recommendation, by means of brief interventions feasible in routine general practice. This     multi-center study was designed to evaluate the effectiveness of a physical activity     promotion program (called PEPAF) implemented in 56 general practices of the Spanish public     primary health care system. The study will test the capacity of the program to increase the     physical activity level, physical fitness and health related quality of life of sedentary     people.   "
174907|NCT00131092|"     The purpose of the study is to compare a telephone-administered physical activity counseling     program delivered by a person or by a telephone-linked computer system and test their     relative benefits in improving regular physical activity among adults ages 55 and older.   "
174908|NCT00131105|"     The purpose of this study is to evaluate the effects of a 12-month telephone-supervised,     home-based physical activity and dietary intervention, conducted in either a sequential or     simultaneous fashion, on improving physical activity and dietary patterns in a high-stress     population.   "
174909|NCT00131118|"     This is an extension study to examine the long-term safety and efficacy of zoledronic acid in     patients who have completed the core CZOL446H2202 study.   "
174910|NCT00131131|"     The specific objective of this project is to study the impact exercise has on gallstone     formation during pregnancy when women are at increased risk due to biochemical and     physiological alterations.   "
174912|NCT00131157|"     More and more general practitioners (GPs) use spirometry in their practices. At this time,     there is sufficient reason to presume that, after a single postgraduate training program     without any further support, most GPs have insufficient knowledge and ability to assure valid     interpretation of their spirometry tests. Therefore, some kind of continuous diagnostic     support with regard to spirometry interpretation by GPs is advisable. The aim of the present     study is to assess whether implementation of spirometry expert support (either by a     computerised expert system or a working agreement between general practitioners and     respiratory consultants with respect to spirometry interpretation) causes changes in     diagnosing and appropriateness and efficiency of medical care in subjects with chronic     respiratory morbidity managed in general practice.   "
174913|NCT00131170|"     The effect of paravertebral block in combination with general anaesthesia is studied in a     double blind fashion.   "
174914|NCT00131183|"     This study aims to address the following questions on the effects of testosterone therapy in     men with coronary ischaemia:        -  Does the anti-anginal effect persist long term? Many of the published studies are acute          single dose trials and none of the chronic studies have assessed patients formally          beyond a few months. The investigators' earlier studies were limited to 3 months.        -  Does testosterone therapy in men affect the levels of measurable atheroma? There is          currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of          atheroma, although there is abundant evidence in animals to suggest a potential          improvement.      This study addresses the two issues and would be of one-year duration but would be the     longest trial of testosterone therapy in men with cardiovascular disease. The primary     endpoint is the change in time to ST- segment depression of > 1mm during exercise testing.   "
174915|NCT00131196|"     The proposal is aimed at identifying genetic factors that determine the incidence and     severity of, and the outcome from life−threatening infections (severe sepsis/septic shock) in     patients admitted to High Dependency Units (HDUs) or Intensive Care Units (ICUs) with     pneumonia which developed outside the hospital (community acquired pneumonia − CAP) or     contamination of the abdominal cavity with faeces due to a leak in the bowel (faecal     peritonitis). This will require the acquisition of a large, high quality resource of genetic     material (DNA), plasma, urine, white blood cells and clinical information from well     characterized groups of similar patients with, or at risk for, severe sepsis/septic shock.     The principal objective is to perform studies which are sufficiently large to establish     beyond doubt the influence of a series of selected candidate genes on the development,     progress and outcome of sepsis.   "
174916|NCT00131209|"     This study tests the hypothesis that infants receiving fortified spread as a complementary     food for one year grow better and do not become malnourished as often as infants who are     provided with maize-soy flour for complementary porridge.   "
174917|NCT00131222|"     This study tests the hypothesis that underweight 6-17-month old infants receiving fortified     spread as a food supplement for 12 weeks grow better during the supplementation than infants     who are provided with maize-soy flour supplement.   "
174918|NCT00131235|"     The purpose of this study is to examine whether treatment of pregnant Malawian women with     repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm     deliveries and result in other health benefits both for the mother and the foetus/newborn.   "
174919|NCT00131248|"     Study Question: In premature infants with apnea and/or bradycardia attributed to     gastroesophageal reflux disease (GERD), does treatment with medications (acid blockers and     motility agents), compared to placebo, reduce the frequency of apnea and bradycardia?      Background: Many clinicians believe that apnea and bradycardia in preterm infants may be     caused by gastroesophageal reflux (GER), however, studies have failed to demonstrate even a     temporal association between episodes of GER and apnea. There have been no prospective     randomized trials of treatment for GERD in preterm infants with apnea or other symptoms     attributed to GER.      Methods: A randomized, cross-over study will be performed. This cross-over design will     provide the patient's clinician with unbiased information about the patient's response to     treatment. The clinician can use this information in deciding whether or not to continue     treatment after the two-week study period.   "
174920|NCT00131261|"     The purpose of this open-label, non-randomized trial is to assess the safety and     effectiveness of PXD101, both alone and in combination with dexamethasone, in patients with     advanced multiple myeloma. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor.     Various members of this class of drugs have shown activity in preclinical studies and in     initial clinical trials of multiple myeloma and lymphoma. Furthermore, HDAC inhibitors,     including PXD101, have been shown to sensitize myeloma cells to the killing effect of other     chemotherapeutic agents, including dexamethasone, a well-established agent in relapsing     myeloma.   "
174923|NCT00131300|"     This clinical study is to evaluate the safety and efficacy of Synvisc in patients with     symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible     administration of a second injection where insufficient symptomatic pain relief was     experienced during the 3 month follow up period.   "
174924|NCT00131313|"     This research study measures the safety and efficacy of the combination of three drugs that     are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia     (CLL). These drugs are being given together for investigational purposes as the specific     combination of these three drugs has not been approved for treatment of CLL by the FDA.   "
174925|NCT00131326|"     This is a clinical study to investigate the safety and efficacy of Synvisc and Depo-Medrol in     treating patients with osteoarthritis (OA) of the hip.   "
174926|NCT00131339|"     This study involves cognitive behavioral therapy (CBT) and a medication called D-cycloserine     (DCS), which is thought to help reduce panic symptoms more effectively by interacting with     N-methyl-D-aspartate (NMDA) glutamate receptors, facilitating many forms of learning     including the extinction of fear. Participants will be randomly assigned (like flipping a     coin) to receive either DCS or a placebo in addition to CBT.   "
174928|NCT00131365|"     The goal of this study is to develop additional long term data to evaluate the safety and     effectiveness of this treatment.      Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid     tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a     uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not     seeking treatment for reasons of improving fertility.'   "
174929|NCT00131378|"     This study will compare growth hormone levels and cardiovascular risk markers in normal     weight and overweight women and men. In women and men with increased abdominal weight, growth     hormone (GH) versus placebo will be administered and effects on cardiovascular risk, insulin     resistance and body composition will be measured.   "
174930|NCT00131391|"     A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an     investigational drug.   "
174931|NCT00131404|"     A study to determine the safety and efficacy of an investigational drug in patients with     obesity plus extension.   "
174932|NCT00131417|"     Severe malnutrition is a major cause of child morbidity and mortality in developing countries     especially sub-Saharan Africa. The hospital mortality rate due to severe malnutrition in     developing countries ranges from 20-30%. For the rehabilitation of severely malnourished     children, the World Health Organization (WHO) recommends a liquid milk-based diet, Formula     100 (F100), which contains 100 kilocalories per 100 milliliters. In Uganda, the     rehabilitation of severely malnourished children is based on High Energy Milk (HEM), which is     reconstituted cows milk with a nutritional composition similar to F100. Recently a semi-solid     ready-to-use therapeutic food (RUTF) with similar composition as F100 or HEM has been     designed. This preparation can be eaten without adding water hence reducing the risk of     bacterial contamination. The preparation can be used at home with minimal supervision.     Hitherto the efficacy of RUTF in the rehabilitation of severely malnourished children in     Uganda has not been studied. The purpose of this study is to determine whether giving daily     RUTF in the rehabilitation of severely malnourished children will result in a higher weight     gain than giving HEM.   "
174933|NCT00131430|"     A study to determine the safety and efficacy of an investigational drug in patients with     obesity.   "
174934|NCT00131443|"     The objective of this study is to assess the effectiveness and safety of topiramate in the     prevention of basilar and hemiplegic migraine in children and adolescents.   "
174935|NCT00131456|"     The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is     effective in treating individuals with marijuana addiction and depression.   "
174936|NCT00131469|"     The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which     is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in     adults affected with Osteogenesis Imperfecta (OI).   "
174937|NCT00131482|"     The purpose of this study is to evaluate the safety of Chrysalin, also known as TP508, and to     determine the effectiveness of four doses of Chrysalin for treating broken wrists in adults.   "
174938|NCT00131495|"     This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal     testosterone patch in naturally or surgically menopausal women with low libido who are not     receiving systemic estrogen or estrogen progestin therapy.   "
174939|NCT00131508|"     Children with sickle cell anemia (SCA) seem to have higher energy needs than children who do     not have the disease. This may be the reason why children and teenagers with sickle cell     anemia tend to be smaller, weigh less, and have less fat and muscle than children and teens     that do not have the disease.      This study is being done to find out if giving a supplement called glutamine will help     children with sickle cell anemia by lowering their energy needs and improving their growth     and strength. Children will be randomly assigned (like a flip of a coin) to one of two     groups. One group will take glutamine and one group will take a placebo (a protein mixture     that looks like glutamine but may not have the same effect in the body). No one will know     which group is taking which supplement until the study has been completed. Children will be     in the study for 12 months.   "
174940|NCT00131521|"     This study compares N-acetylcysteine (mucomyst) and sodium chloride to determine their     efficacy in the prevention of pulmonary mucus obstruction and retention in intubated patients     admitted to the surgical trauma intensive care unit (STICU).   "
174941|NCT00131534|"     The overall purpose of this study is the assessment of treatment outcome among traumatized     patients seeking individual and/or group therapy at the Victims of Violence Program. The     study gathers information from patients using quantitative (self-report) and qualitative     (interview-based) approaches, to determine changes in symptom patterns and domains of     functioning relevant to psychological trauma.   "
174942|NCT00131547|"     The purpose of the study is to determine if weight loss interventions aimed at lifestyle     modification (dietary education, food diary pedometer) result in weight loss in patients with     mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The     secondary purpose of the study is to determine if the amount of weight loss achieved in a 6     month period results in improvements in snoring and other symptoms and in the frequency of     apnea on overnight monitoring.   "
174943|NCT00131560|"     This study uses autologous (one's own) CD4 T cells modified with a viral vector expressing a     genetic antisense targeting HIV, this vector is called VRX496. Study treatment is by     intravenous infusion of vector modified cells and infusions will be provided every other week     for a total of 4 or 8 doses. These modified cells, once infused, may provide immune support     and are not destroyed by HIV, and thus may delay or reverse HIV disease progression. The     study will enroll up to 40 male and female HIV-positive subjects in up to 8 centers. Subjects     will be 18 years of age and over who have failed or are intolerant to at least one triple     combination of antiretroviral drugs. Subjects must have a viral load between 5,000 and     200,000 copies/ml and a CD4+ count of ≥150, be in good health and have no evidence of active     opportunistic infection, heart disease, or bleeding disorders. Subjects must not be on     corticosteroids, immunomodulating agents or hydroxyurea. Subjects must not have received an     AIDS vaccine or any investigational gene therapy product at any time. Females must not be     pregnant or breastfeeding.   "
174944|NCT00131573|"     The goal of this study is to investigate the safety and effectiveness of a new implanted     device designed to treat Urinary Urgency-Frequency Syndrome.   "
174945|NCT00131586|"     Cisplatin is a widely used anti-tumor agent for the treatment of testicular and ovarian     cancers. Carboplatin is used extensively for small cell, non small cell lung cancer and     ovarian cancer. Oxaliplatin has recently been approved in the United States (US) for     treatment of colorectal cancer. A large portion (in the range of 65% to 98%) of cisplatin in     the blood plasma was bound to protein within a day after intravenous administration. The     binding of cisplatin and other analogues to proteins and enzymes is generally believed to be     the cause of several severe side effects such as ototoxicity and nephrotoxicity. The     interactions between platinum based chemotherapy drugs and proteins is proposed to play     important roles in both drug activity and toxicity. Therefore, a better understanding of the     molecular mechanism of platinum-protein interactions may have an impact on optimization of     strategies for treatment. The objective is to develop novel approaches and techniques to     provide detailed mechanistic, kinetic and high-resolution structural information on the     binding of platinum analogues to blood proteins, and to improve treatment efficacy and reduce     side effects.   "
174946|NCT00131599|"     Cancer of the colon and rectum are the third most common cancers in Canadian males and     females. The initial therapy of colorectal cancer is surgery to remove the cancer and nearby     lymph glands. If the cancer has spread to the lymph glands there is a high chance that the     cancer will come back. To reduce the risk of the cancer recurring, patients are treated with     an anticancer drug 5-fluorouracil (5FU) in combination with a vitamin leucovorin (LV). This     study will determine if a simple blood test can predict which patients are at risk for     developing side effects from this chemotherapy. In addition, participants of this study will     be followed to determine if this same blood test will predict which patients will have their     cancer relapse.   "
174947|NCT00131612|"     For many years scientists and cancer researchers have been trying to find out why some people     benefit more from anti-cancer medications than other people who receive the same amount and     same kind of medications. Current studies suggest that inherited characteristics might     explain these differences. Height and eye color are examples of characteristics that have     been inherited from parents. Studies suggest that people might also inherit genetic     differences in how their bodies break down medications. When a person receives an anti-cancer     medication, it is broken down by the liver into smaller parts or by-products. To try to     understand more about how people's bodies break down anti-cancer medications, the researchers     are studying the by-products (called metabolites) of epirubicin in the blood of people who     are taking this medication as part of their breast cancer treatment.   "
174948|NCT00124319|"     The anterior cruciate ligament (ACL) is located inside the knee joint and provides stability     to the knee. ACL injuries occur more frequently in women than men; the reason for this is     unknown. The purpose of this study is to determine gender-specific anatomical, hormonal, and     demographic risk factors for ACL injury. This observational cohort study will only enroll     incoming cadets at the U.S. Naval, Air Force, or Military Academies.      Study hypothesis: Human movement factors, including key kinetics and kinematics of the knee     during a jump-landing task, are associated with the rate of ACL injury.   "
174949|NCT00124332|"     The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered     during 18-20 months will reduce progression of coronary atherosclerosis as assessed by     intravascular ultrasound (IVUS) when administered on top of standard behavioral and     pharmacological therapy given as needed, in patients with abdominal obesity associated with     current smoking and/or metabolic syndrome.   "
174950|NCT00124345|"     In this study, the investigators aimed to study the role of medical gas humidification during     noninvasive mechanical ventilation.   "
174951|NCT00124358|"     The purpose of this study is to assess the feasibility, cost and effectiveness of     interventions designed to integrate buprenorphine treatment for opioid dependence into HIV     primary care in ten HIV care centers in the U.S.   "
174952|NCT00124371|"     The time spent waiting for heart surgery can be extremely stressful. This programme aims to     address this by providing a home-based, nurse-led support and education programme. Patients     will be followed up in their own homes monthly by a cardiac nurse and given lifestyle advice     and information to prepare them for surgery. This will be evaluated to test whether providing     this support improves patients’ anxiety and quality of life while they wait and also whether     their blood pressure, weight and cholesterol are reduced and they have a smoother recovery as     a consequence.   "
174953|NCT00124384|"     This study examines how treatment with the drug modafinil, by itself or in combination with     cognitive behavioral treatment for insomnia (CBT-I), may improve daytime functioning and/or     diminish the severity of insomnia.   "
174954|NCT00124397|"     The aim of this study is to examine the effect of intensive cholesterol lowering therapy and     tight blood pressure (BP) regulation on endothelial function (inner cell layer of vessels     that determines dilatation) in type 2 diabetic patients without documented cardiovascular     (CV) disease. The hypothesis is that intensive cholesterol lowering and tight blood pressure     regulation will due better than a control group.   "
175604|NCT00140920|"     A study to compare pre-operative administration of rofecoxib versus post-operative     administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative     pain after total knee joint replacement in patients with osteoarthritis of the knee.   "
174955|NCT00124410|"     Osteoporosis, or thinning of the bones is a common disorder which can cause significant     morbidity in terms of pain and fracture. One of the causes of osteoporosis is a low or absent     testosterone level. Prostate cancer is the second most common malignancy in males with an     increasing incidence. The mainstay of advanced prostate cancer treatment is hormonal     manipulation (surgery or medications) in order to lower testosterone levels as testosterone     stimulates cancer cells. Despite the known links both between osteoporosis, low testosterone,     and prostate cancer, little data is available on how common osteoporosis is among men with     advanced prostate cancer treated with hormonal manipulation. Since prostate cancer affects so     many men and the indications for early hormonal manipulation are expanding, it is important     to determine the prevalence of osteoporosis in these males.   "
174980|NCT00131781|"     This is a randomised trial comparing cognitive therapy and supportive therapy administered     along one year in borderline personality disorder. The follow-up is one year after treatments     end.      The therapists were the same in the two groups. Patients received one session a week during     six months and one session every two weeks during the next six months   "
175020|NCT00132652|"     This study is being conducted to compare the safety and effectiveness of switching treatment     from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from     patients who were taking lamivudine and then switched to telbivudine will be compared with     the results from patients who continued on lamivudine alone.   "
174956|NCT00124423|"     The Cross Cancer Institute has recently acquired a tomotherapy radiotherapy treatment     machine; the first of its kind in Canada. It has the potential to improve cancer treatment     outcomes where radiotherapy is used. Cervix cancer is a disease where radiotherapy is a     particularly important treatment modality. The researchers believe that by combining     tomotherapy (which has the ability to give higher doses of radiation to areas of cancer while     sparing normal tissues) with radiotherapy given from inside the uterus and vagina     (brachytherapy) disease outcomes will be improved. For this to be possible the researchers     will need to accurately map the doses of radiation given to the cervix, uterus and other     pelvic organs from these two types of radiation treatment. As well as being used for     treatment, the tomotherapy machine can also be used for taking medical images by using very     much lower doses of radiation. This study will allow the researchers to develop the mapping     process by using very low doses of radiation on the tomotherapy unit to take medical x-ray     images of patients being treated by brachytherapy for cervix cancer. In this special     circumstance the researchers expect the images to be of a higher quality than for     conventional computed tomography (CT) scanning or magnetic resonance imaging (MRI) scanning.   "
174957|NCT00124436|"     Patients who have been treated in study protocol BAP089 may have responded to treatment, and     subsequently relapsed to >75% of the baseline disease severity, will be investigated for     response to further treatment with alitretinoin. Also, patients who have responded with mild     or moderate disease will be investigated for additional treatment effect after prolongated     treatment.   "
174958|NCT00124449|"     The purpose of this study is to assess if Abatacept given for six months will prevent     rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison     to placebo. High risk patients are defined as those having a positive laboratory test for     anti-cyclic citrullinated peptide (anti-CCP2).   "
174959|NCT00124462|"     The overall objective of this 3-year project is to determine whether the provision of     realignment therapy in patients with medial knee osteoarthritis (OA) relieves knee pain and     improves function. The researchers will test the hypothesis that compared to control     treatment, the use of realignment therapy (valgus knee brace + motion control shoes +     orthosis) is effective in medial knee OA.      The specific aims are:        -  To undertake a 30 week randomized crossover clinical trial in patients with medial knee          osteoarthritis to determine whether provision of realignment therapy leads to lower pain          scores and improved function during the time of this treatment than during the use of a          placebo treatment;        -  To perform an open label follow-up study to track use and effectiveness of treatment.          This project will be co-funded by DonJoy Orthopedic, a knee bracing company.   "
174960|NCT00124475|"     The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid,     on severe, therapy refractory chronic hand dermatitis.   "
174961|NCT00124488|"     Standard treatment for non-operable cervix cancer is radiation and chemotherapy. This     treatment combination can result in significant radiation side-effects involving the bladder,     small bowel and rectum. To improve results with radiation/chemotherapy, higher radiation     doses have been tried for cervix cancer patients. Results from using higher radiation doses     show that cervix tumours may be better controlled, but the radiation side-effects are     worsened. Intensity modulated radiotherapy (IMRT) and Tomotherapy are new radiation planning     and delivery technologies which may allow for delivery of higher radiation doses with less     damage to normal organs. The purpose of this project is to determine whether or not IMRT     and/or Tomotherapy technology can produce radiation plans that deliver higher doses of     radiation to the tumor and lower doses to normal organs when compared to standard radiation     plans. The results from this project will provide the basis for possibly treating future     cervix cancer patients with Tomotherapy and providing them with improved cure rates along     with decreased rates of radiation side effects. No patients will be treated on this protocol,     as the investigators plan to only compare radiation dose calculations from different     treatment plans created for test cervix cancer cases. There will be absolutely no patient     contact in this protocol.   "
174962|NCT00124501|"     The purpose of this study is to determine whether the addition of Biofeedback-Assisted     Relaxation to standard medication treatment improves outcomes for children with a specific     type of recurrent abdominal pain (i.e., eosinophilic gastroenteritis).   "
174990|NCT00131911|"     This phase II trial is studying how well sorafenib tosylate works in treating patients with     progressive metastatic neuroendocrine tumors. Sorafenib tosylate may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to     the tumor.   "
174991|NCT00131924|"     RATIONALE: High doses of esterified estrogens may stop the growth of breast cancer cells that     no longer respond to hormone therapy.      PURPOSE: This phase II trial is studying how well high-dose esterified estrogens work in     treating postmenopausal women with metastatic breast cancer that has failed previous hormone     therapy.   "
174963|NCT00124514|"     The purpose of this study is to test the safety of triptorelin when used for the protection     of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for     systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on     patients. The study will be done with female patients who have been diagnosed with systemic     lupus erythematosus, are younger than 21 years of age, and require intravenous     cyclophosphamide to control the disease. Each patient will be in the study for approximately     23 months, until 4 months after the intravenous cyclophosphamide treatment has been     completed.      This study is currently being conducted at 3 sites across the United States and Brazil (Los     Angeles, Cincinnati and San Paulo Brazil). A total of 50 patients will participate in this     study.      Each patient will be randomized (assigned) to one of 5 groups. Randomization means that     patients are put into a group completely by chance. It is like flipping a coin. Neither the     patient nor the study staff knows what group the patient is in. The patient has a 20% chance     of being placed in any group.      Funding Source: FDA OOPD and Watson Pharmaceuticals   "
174964|NCT00124527|"     Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid     tumors. The purpose of this study is to assess the efficacy and safety of     irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally     advanced/metastatic differentiated thyroid cancer.   "
174965|NCT00124540|"     This hospital-based, multicenter, randomized, placebo-controlled trial will assess the     effects of misoprostol as part of active management of the third stage of labor on postpartum     blood loss, complications, and side effects. Twelve hundred eligible women will receive     routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo     during or immediately after delivery. The primary outcome will be measured blood loss of     =>500 mls within one hour after enrollment.   "
175016|NCT00132600|"     The purpose of this study is to establish a concentration of a bacitracin-patch for     diagnosing allergic contact dermatitis.   "
174966|NCT00124553|"     In the past, nutritional management formed the cornerstone of treatment of type 2 diabetes     (T2DM). More recently, this aspect of treatment has received less attention as drug therapy     aimed not only to lower glucose, but also to treat raised blood pressure and blood fats     (including cholesterol) has been more widespread. While there is evidence to suggest that     blood pressure and blood fat levels have improved, overall diabetes control has not and     people with diabetes appear to be becoming progressively more overweight, following trends in     the general population. The proposed study involves a randomised controlled trial in which     people with T2DM continuing with their regular drug treatment and surveillance, will be     randomly allocated to additionally receive intensive advice regarding diet or remain on their     usual treatment in this regard. The results will be judged principally in terms of body     weight, waist circumference, blood pressure, blood glucose control and blood fats.   "
174967|NCT00124566|"     The purpose of this study is to assess the efficacy and safety of irofulven-based regimens     compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer     (HRPC) whose disease has progressed following Taxotere based regimens.   "
174968|NCT00131625|"     Exclusive breastfeeding is promoted by the World Health Organization (WHO) with the aim of     improving infant health. The specific objective of the study was to examine the effect of     exclusive breast-feeding on morbidity and mortality in a randomised prospective study.     Children born by mothers recorded as living in the study area during pregnancy was randomised     at birth. WHO recommendations to postpone introduction of water and weaning food were told to     the mother by 2-weekly home visits. All study children were followed from birth till 1 year     of age according to morbidity, hospitalisation and mortality.   "
174969|NCT00131638|"     The purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant     human keratinocyte growth factor, rHuKGF) in reducing the incidence of severe oral mucositis     in subjects with locally advanced head and neck cancer receiving radiotherapy with concurrent     chemotherapy as adjuvant treatment for their disease.   "
174970|NCT00131651|"     The purpose of this study is to determine an active dose of ATN-161 for future studies while     establishing preliminary evidence of effectiveness in patients with renal cell cancer.   "
174971|NCT00131664|"     The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes     Association guidelines glucose control, based on the A1C measurement, needs to be achieved     within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The     guidelines on the use of antihyperglycemic agents identify the potential benefits of     sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic     control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral     antihyperglycemic monotherapy who then start on combination therapy may not achieve the     required target glycemic control. Indeed early initiation of combination therapies may be     necessary to achieve and maintain glycemic targets because of the progressive deterioration     of pancreatic β cell function and glycemic control.   "
174972|NCT00131677|"     The purpose of this study is to examine safety and tolerability of daily tenofovir use in     HIV-uninfected men.   "
174973|NCT00131690|"     The purpose of this study is to determine whether caffeine has any effect on birth weight.   "
174974|NCT00131703|"     Malaria in pregnancy is potentially fatal to both the mother and the foetus particularly in     the primigravidae. Implementation of appropriate control and preventive measures is     challenged by the fact that malaria infection in pregnancy is often asymptomatic and     parasitized red blood cells sequestrated in the placental microcirculation may not be     detectable in the peripheral blood. In addition, the widespread prevalence of parasites     resistant to chloroquine and sulphadoxine-pyrimethamine (SP) and, the safety concerns about     newer antimalarials, poverty and inadequate supply have made antimalarial treatment options     available to pregnant women very limited. These have necessitated an urgent search for     alternative safe and efficacious treatment options for pregnant women. The objective of this     study is to assess the efficacy, safety and tolerability of four antimalarial treatment     options in rural Ghana within a programme setting.   "
174992|NCT00131937|"     This phase II trial is studying how well sorafenib works in treating patients with recurrent     diffuse large B-cell non-Hodgkin's lymphoma. Sorafenib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
174975|NCT00131716|"     Severe anaemia is a frequent cause of admission to hospitals in tropical Africa and about 10%     of such children die. In endemic countries, anaemia has multiple causes such as nutritional     deficiencies, infections and haemoglobinopathies. However, Plasmodium falciparum infection is     believed to be the major contributory factor to the aetiology of severe anaemia. Severe     anaemia is usually treated by blood transfusion although transfusion carries the attendant     risk of transmission of HIV and other blood-borne infections. Thus, there is a need to     explore novel strategies to reduce the incidence of severe anaemia in high-risk groups such     as children with suboptimal haemoglobin levels because these children are at increased risk     of developing severe anaemia if they develop a malaria infection before their haemoglobin     level has normalized. Therefore, it is proposed to study whether monthly chemoprophylaxis     with sulphadoxine/pyrimethamine (S/P) given during malaria transmission season can protect     Gambian children from developing severe anaemia. After receiving treatment from the hospital,     1200 children admitted to the hospital with a haematocrit of less than 21% were randomised to     receive either monthly S/P or placebo during the rest of the malaria transmission season.     Morbidity was monitored throughout the rainy season. Study subjects were seen at the end of     the dry season to document morbidity and mortality.   "
174976|NCT00131729|"     The purpose of this study was to determine whether compliance with occlusion therapy for     amblyopia could be improved and, secondly, if risk factors for non-compliance could be     identified.   "
174977|NCT00131742|"     This study is being conducted to compare the effectiveness and safety of telbivudine (LdT)     and lamivudine in Chinese adults.   "
174978|NCT00131755|"     The purpose of this study is to find out if Diazoxide can partly retain insulin production in     newly diagnosed type 1 diabetes patients.   "
174979|NCT00131768|"     This clinical study is to evaluate the safety and efficacy of Synvisc in patients with     symptomatic ankle osteoarthritis (OA). Patients will be given Synvisc, with the possible     administration of a second injection where insufficient symptomatic pain relief was     experienced during the initial 3 months follow up period.   "
175017|NCT00132613|"     The purpose of this study is to evaluate the efficacy of pericardial instillation of     bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated     malignant pericardial effusion.   "
174981|NCT00131794|"     BCG vaccine is given at or shortly after birth in many developing countries to prevent     tuberculosis. In Guinea Bissau, it has been shown that its protective effect against death is     greater than would be expected from its effect against tuberculosis. This observation     suggests that BCG may enhance the ability of the immune system of young children to make a     protective response to other infections, including malaria. There is some evidence to support     this hypothesis as BCG protects against malaria in experimental animals.      Because BCG is a recommended vaccine, a randomised controlled trial of BCG at birth would not     be ethically justifiable. However, it is not known whether re-vaccination with BCG in the     second year of life might provide some added benefit and a large study to determine this is     under way in Guinea Bissau. This study examined the effect of re-vaccination with BCG on the     incidence of clinical malaria. If re-vaccination with BCG at 19 months of age is found to     protect against malaria this would support the hypothesis that one of the ways that BCG at     birth provides protection to young children is through an effect on malaria.   "
174982|NCT00131807|"     The purpose of this study is to explore the association between blood pressure, HIV and/or     its treatment in a cross sectional observational study.   "
174983|NCT00131820|"     This study is part of International Vaccine Institutes (IVI)'s typhoid Vi demonstration     project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic     countries. The primary objectives of the study are to evaluate the logistic feasibility of a     mass typhoid fever immunization campaign program targeting school age children in Hue City,     Vietnam and to assess the knowledge, attitudes, beliefs, and practices of parents and     healthcare providers in Hue City regarding typhoid fever prevention and treatment.   "
174984|NCT00131833|"     This study is part of International Vaccine Institute (IVI)'s typhoid Vi demonstration     project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic     countries. The purpose of this study is to determine the effectiveness of the Vi vaccine     following a mass typhoid immunization campaign in an endemic area in Hechi City in the     Guangxhi province of China. The cost-effectiveness and safety of Vi vaccination will also be     evaluated.   "
174985|NCT00131846|"     The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic     adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose     diuretics. The researchers' hypothesis is that use of low dose thiazide diuretics is     metabolically safe when used with other appropriate antihypertensives, effective in reduction     of blood pressure and cheaper than treatment without diuretics. Therefore, this study is an     equivalence trial.   "
174986|NCT00131859|"     The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants     diagnosed with cerebral white matter injury during the neonatal period and identify antenatal     risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial     gas results that are associated with cerebral white matter injury. The researchers'     hypothesis is that this new imaging technique will help us better understand how these     devastating injuries occur.   "
174987|NCT00131872|"     The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE     grafts for effectiveness in maintaining primary or assisted primary patency.   "
174988|NCT00131885|"     This study will determine the effects of St. John's wort, a common herbal remedy, on     metabolism of the female contraceptive hormone levonorgestrel.   "
174989|NCT00131898|"     This is a phase III clinical trial for patients with potentially completely resectable     primary retroperitoneal sarcoma. Patients who take part will be divided into two groups, a     radiation therapy plus surgery group and a surgery alone group.      Patients in the radiation therapy plus surgery group will receive radiation treatments as an     outpatient. Surgery to try to remove the remaining tumor will be done after the radiation     treatments are completed.      Patients in the surgery alone group will have surgery to try to remove all tumor.   "
175605|NCT00140933|"     Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or     placebo or diclofenac and fill out a patient diary on daytime pain severity during daily     activities, night pain severity, and acetaminophen/paracetamol intake.   "
174993|NCT00131950|"     RATIONALE: Lifestyle factors, such as physical activity, diet, and obesity, and hormone     function may affect breast density. Screening tests, such as mammography, may help doctors     find tumor cells early and plan better treatment for breast cancer.      PURPOSE: This clinical trial is studying the effect of lifestyle factors and hormone function     on breast density in healthy Hispanic women who are undergoing mammography for breast cancer     screening.   "
174994|NCT00132314|"     In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least     one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly     assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of     oral antipsychotic medication (i.e., excluding other long-acting injectable medications, but     not specifying any particular oral agents or dosages). Recruitment would take 27 months to     complete, and the study would continue for a third year to allow 9 months of follow-up for     the last patient recruited. All patients would be treated from the time of entry up to the     end of the three-year study period. Follow-up assessments would continue quarterly.     Treatments would not be blinded since giving placebo injections to the comparison group would     interfere with the goal of comparing the acceptability of two different methods of medication     administration. However, end points will be blindly rated.   "
175018|NCT00132626|"     This study assesses dopamine transporter density using single photon emission computed     tomography (SPECT) brain imaging with an investigational radiopharmaceutical, [123I]ß-CIT, in     research participants with Parkinson's disease.   "
174995|NCT00132327|"     This study will analyze cells from erythema migrans lesions, the bull's eye rash of Lyme     disease. Little is known about what happens in the skin when it is infected with Borrelia     burgdorferi, the bacteria that cause Lyme disease. This study will examine and compare     laboratory findings in skin biopsies from people with Lyme disease and from healthy normal     volunteers to try to better understand the infection.      Healthy volunteers and people with untreated erythema migrans rash who are 18 years of age or     older may be eligible for this study.      All participants undergo a clinical examination, blood tests, between two to four skin     biopsies (removal of a small piece of tissue for laboratory examination), and complete two     health questionnaires. The biopsies are taken from the erythema migrans lesion in patients     with Lyme disease and from skin on the legs, forearms, buttocks, or side from healthy     volunteers. To collect the tissue, the skin at the biopsy site is numbed with injection of a     local anesthetic and a sharp instrument is then used to remove a round plug of skin about the     size of a pencil eraser. The wound may be closed with one or two sutures, or allowed to heal     without sutures. The sutures are removed after a week to 10 days.      Patients with Lyme disease receive treatment for their condition. In addition, at the time     the sutures are removed and at 4 weeks, 6 months, and 12 months after their first visit they     fill out a questionnaire and have additional blood tests.   "
174996|NCT00132340|"     This study will evaluate the effectiveness of deep brain stimulation (DBS) for treating     primary dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting     and repetitive movement or abnormal postures. Medical therapies are available, but not all     patients get adequate relief from the abnormal movements or the pain associated with them.     DBS is a surgical procedure that interrupts neuronal circuits in the globus pallidus interna     (Gpi) and subthalamic nucleus (STN) - areas of the basal ganglia of the brain that do not     work correctly in patients with dystonia. This results in decreased movement and therefore     may lessen patients' symptoms and pain. The study will also examine the physiology of     dystonia and determine whether the treatment effects of DBS in the Gpi differ significantly     from DBS of the STN.      Patients 18 years of age and older with primary cervical dystonia that does not respond to     medical treatment or botulinum toxin (Botox) may be eligible for this study. Candidates are     screened with blood and urine tests, chest x-ray, electrocardiogram, and magnetic resonance     imaging (MRI, see below) of the brain.      Each participant undergoes the following tests and procedures:        -  Magnetic resonance imaging. This procedure is done after implantation of the stimulators          to verify position of the electrodes. MRI uses a magnetic field and radio waves to          produce images of the brain. The patient lies on a table that is moved into the scanner          (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that          occur during the scanning process. The procedure usually lasts about 45 to 90 minutes,          during which the patient is asked to lie still for up to 15 minutes at a time.        -  Transcranial magnetic stimulation. This procedure maps brain function. A wire coil is          held on the scalp, and a brief electrical current is passed through the coil, creating a          magnetic pulse that stimulates the brain. During the stimulation, the patient may be          asked to tense certain muscles slightly or perform other simple actions. The stimulation          may cause a twitch in muscles of the face, arm, or leg, and the patient may hear a click          and feel a pulling sensation on the skin under the coil. During the stimulation,          electrical activity of muscles is recorded with a computer, using electrodes attached to          the skin with tape.        -  Neurologic evaluation. Before and after DBS, the patient's dystonia is measured with a          standardized rating scale called the Toronto Western Spasmodic Torticollis Scale          (TWSTRS).        -  DBS treatment. Patients are randomly assigned to have electrodes implanted in either the          Gpi or STN area of the basal ganglia. The electrodes are what stimulate the brain in DBS          therapy. Before surgery, a frame is secured to the patient's head, and an MRI scan is          done. DBS involves making two small incisions and two small holes in the skull, opening          the lining around the brain, locating the Gpi or STN, securing the electrodes in place,          and connecting them to the pulse generator that is placed under the skin below the          collar bone. In addition, during the surgery, the patient is asked to move certain          muscles. The muscle activity is recorded to gain a better understanding of the          physiology of movement. After surgery, MRI scans are done to confirm placement of the          electrodes.        -  Stimulation and evaluation. After surgery, patients' movements are evaluated during and          after stimulation. The changes in movement and function are videotaped and scored          according to a rating scale. The optimal stimulation settings are determined and the          stimulators are adjusted accordingly.      Neurologic evaluations with the TWSTRS scale are repeated at 1, 2, 3, 6 and 12 months after     surgery, and the stimulators are adjusted as needed. Some of the evaluations are videotaped.   "
174997|NCT00132353|"     This training protocol has two objectives: 1) to train NINDS fellows in specialized     techniques for diagnosing neurological disorders, and 2) to gather data from healthy     volunteers and from patients with various disorders needed for tests to diagnose disorders of     nerve, muscle, and the areas of the brain controlling movement.      Healthy volunteers and patients with neurological disorders of nerve and muscle who require     specialized diagnostic testing may be eligible for this study. Candidates must be 18 years of     age or older. They are screened with a medical history and neurological examination.      Immediately after screening, participants undergo one or two of the following tests:        -  Transcranial magnetic stimulation: This procedure maps brain function. A wire coil is          held on the scalp, and a brief electrical current is passed through the coil, creating a          magnetic pulse that stimulates the brain. During the stimulation, the subject may be          asked to tense certain muscles slightly or perform other simple actions. The stimulation          may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click          and feel a pulling sensation on the skin under the coil. During the stimulation,          electrical activity of muscles is recorded with a computer, using electrodes (small          metal disks) attached to the skin with tape.        -  Electromyography (EMG): This test measures the electrical activity of muscles and is          used to diagnose problems with the nerves or muscles. For surface EMG, electrodes are          filed with a conductive gel and taped to the skin. Needle EMG involves inserting a          needle into a muscle to record the electrical activity. Single fiber EMG uses          specialized needles that allow recording from single muscle fibers. The needle is          inserted into a muscle and the subject is asked to tense that muscle slightly.        -  Nerve conduction study: This test measures the speed with which nerves conduct          electrical impulses and the strength of the connection between the nerve and the muscle.          It is done by taping wires on the skin to record the impulses and placing a probe on the          skin to deliver a small electrical stimulus.        -  Near-nerve recording: This test is a nerve conduction study that is used to measure          responses from very small nerves. It uses a needle placed under the skin to record the          nerve response.        -  Quantitative sensory testing: This test measures how well the subject feels vibration          and cold. A probe that can vibrate or cool down is attached to the subject's finger or          foot. The subject presses a button when he or she feels the stimulus. A computer adjusts          the intensity of the stimulus to find the lowest level the subject can feel.        -  Nerve ultrasound: This test uses sound waves to examine the nerves. Warm gel is applied          to the skin and a probe is held on the skin surface.   "
174998|NCT00132366|"     This study will measure brain excitability in patients with succinic semialdehyde     dehydrogenase (SSADH) deficiency, and in their parents. SSADH is a rare inherited disease in     which changes in certain brain chemicals affect brain cell activity. Symptoms vary greatly     among patients, and may include mental retardation, impaired ability to coordinate movements,     and delays in language and speech development. Other symptoms may include poor muscle tone,     uncontrolled seizures and other neurological or behavioral abnormalities. Test findings in     patients and their parents will be compared with those of healthy normal volunteers.      The following individuals may be eligible for this study: patients with SSADH who are between     5 and 24 years of age; parents of patients who are between 18 and 55 years of age; healthy     normal children who are between 10 and 17 years of age; and healthy normal adults who are     between 18 and 55 years of age. Candidates are screened with blood and urine tests.      All participants undergo the following:        -  Transcranial magnetic stimulation (TMS): This procedure maps brain function. A wire coil          is held on the scalp, and a brief electrical current is passed through the coil,          creating a magnetic pulse that stimulates the brain. During the stimulation, the subject          may be asked to tense certain muscles slightly or perform other simple actions to help          position the coil properly. The stimulation may cause a twitch in muscles of the face,          arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin          under the coil. During the test, electrical activity of muscles is recorded with a          computer or other recording device, using electrodes attached to the skin with tape.        -  Magnetic resonance imaging (MRI): This test combines a powerful magnet with an advanced          computer system and radio waves to produce accurate, detailed pictures of organs and          tissues. During the scan, the subject lies on a table in a narrow cylinder containing a          magnetic field, wearing ear plugs to muffle loud noises that occur with electrical          switching of the magnetic fields. He or she can speak with a staff member via an          intercom system at all times during the procedure. In addition to standard MRI, subjects          may have newer MRI tests, such as diffusion tensor MRI and magnetic resonance          spectroscopy.      In addition to the above, patients and their parents may also undergo the following tests:        -  Electroencephalography (EEG): This test records brain waves (electrical activity of the          brain). Electrodes are placed on the scalp and brain electrical activity is recorded          while the subject lies quietly, breathes deeply, watches flashes of light, or sleeps.          Some patients may also have video-EEG monitoring, which involves simultaneous clinical          recording using a video camera along with brain wave recording.        -  Sleep study and multiple sleep latency onset testing (MSLT): Electrodes are placed on          the subject's scalp and remain there while the subject sleeps in the hospital overnight.          MSLT is done the next day, starting 2 hours after the subject wakes up from the night's          sleep. A total of five 20- to 30-minute naps are recorded, each every 2 hours, to access          daytime sleepiness.        -  Nerve conduction studies: This test measures the speed with which nerves conduct          electrical impulses and the strength of the connection between the nerve and the muscle.          A probe is placed on the skin to deliver a small electrical stimulus, and wires taped on          the skin record the impulses.   "
174999|NCT00132379|"     The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one     that triggers an attack on the tumor cells by activating some white blood cells belonging to     the body's normal immune system. In animals, this results in an accumulation of white blood     cells in the cancer that can fight the cancer. This study will test how much of the drug, in     combination with docetaxel (an approved drug for treating non-small cell lung cancer     [NSCLC]), can be given to patients with NSCLC without causing unacceptable side effects.   "
175000|NCT00132392|"     ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of     surgery for total replacement of the knee.      Each subject will undergo a screening visit; a hospitalization, during which total     replacement of the knee will be performed; and follow-up visits at 2, 6, and 12 weeks after     surgery. In addition, once discharged, subjects will be contacted by telephone daily up to     Day 14. Subjects will complete pain and medication diaries during the first 2 weeks following     surgery and will return these diaries at the 2 week visit.      Starting on the afternoon of Day 0 (the day of surgery), pain on active range of motion (ROM)     of the operated knee will be measured each morning at 8 AM ± 2 hours and each afternoon at 3     PM ± 3 hours. In addition, if the subject ambulates, pain with ambulation will be measured     during the first ambulation in the morning and during the first ambulation after noon.     Subjects will complete the Brief Pain Inventory - Short Form (BPI-SF) preoperatively, and at     the 2, 6, and 12 week visits. Subjects will be questioned regarding the use of assistive     devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at screening,     at discharge, and at the 2, 6, and 12 week visits. The active ROM on flexion of the knee,     measured using a goniometer, will be recorded at screening and at the 2 week visit. Sensory     mapping of the knee will be performed at screening and at the 12 week visit.   "
175488|NCT00139243|"     The purpose of this study is to determine the safety and maximum tolerated dose of the     combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily     assess whether the combination is effective in treating squamous cell carcinoma of the head     and neck.   "
175001|NCT00132405|"     Minor needlestick procedures often cause significant pain and distress in children, yet     interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use,     prefilled, needle-free dispenser that immediately delivers powdered lidocaine into the     epidermis and provides local analgesia in 2 to 3 minutes. The purpose of this prospective,     randomized, double-blind, and placebo-controlled trial is to determine the efficacy and     tolerability of ALGRX 3268 in children aged 3 to 18 years undergoing venipuncture. The trial     will enroll a total of 306 children aged 3 to 18 years scheduled to undergo venipuncture of     the back of the hand at a single study center.   "
175002|NCT00132418|"     The objective of this study was to evaluate the safety of Enbrel (etanercept) in rheumatoid     arthritis (RA) subjects with greater than or equal to 1 documented comorbid disease (diabetes     mellitus; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis,     sinusitis, or urinary tract infection) that might increase infection risk.   "
175003|NCT00132431|"     The purpose of this research is to study the effects and safety of Sensipar approved by the     Food and Drug Administration (FDA) in patients with kidney failure who are being treated with     dialysis and have uncontrolled secondary hyperparathyroidism (HPT).   "
175004|NCT00132444|"     This study will help determine whether the agent UC-781, formulated as a gel, is safe when     applied to the vagina twice daily for 14 days. It will also assess whether women find the gel     acceptable to use.   "
175005|NCT00132457|"     The purpose of this study is to determine if, among women who were treated for a prior     chlamydial infection, home-based, self-collected vaginal swabs can increase rescreening for     chlamydia in comparison with rescreening in the clinic. The study design is two randomized     trials with enrollment at multiple family planning clinics and sexually transmitted disease     (STD) clinics following a common protocol.   "
175006|NCT00132470|"     The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa     trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for     acute ischemic stroke. The primary objective of the present phase IIa study is to assess the     safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke.     The secondary objective is to assess the effect of AX200 on subject outcome in comparison to     placebo.   "
175007|NCT00132483|"     Summary      This study will look at physical exercise after acute ischaemic stroke. It is called the     ExStroke Pilot Trial.      Physical activity is associated with a lower risk of first-time stroke. It remains unknown if     physical activity also is associated with a lower risk of recurrent stroke. Patients with     ischaemic stroke have a 30% to 40% risk of a recurrent stroke during a 5 year follow-up. The     risk of acute myocardial infarction (MI) and death from vascular disease is approximately 15%     each. The impact of lifestyle factors on risk for these events is insufficiently covered in     the international scientific literature.      Purpose:      The purpose of the trial is to examine whether the level of physical activity increases in     patients who have had an ischemic stroke, when they are informed about physical activity and     instructed in a physical training program. The occurrence of new cerebro- and cardiovascular     events in the patients will be registered. The patients are randomised to receive oral and     written information by a physician and a physiotherapist about physical exercise; or to a     control group with no instruction regarding physical exercise. Both groups will receive the     best available therapy with regard to secondary stroke prevention and will be informed about     lifestyle factors.      Irrespective of which group the patients are randomised to, all patients will receive the     best possible established treatment with regard to prevention of thromboses; blood pressure     control; lipid lowering agents, if necessary; and information about diet, tobacco smoking,     and vitamin supplements.      Study Design:      The patients will be randomised centrally within 90 days after stroke onset, and they will be     re-examined at 3, 6, 9, 12, 18, and 24 months. Inclusion criteria are patients with ischaemic     stroke, aged 40 years or older. In the pilot trial a number of 300 included patients is     wanted.   "
175008|NCT00132496|"     The primary objective of this study is to collect safety information on rabeprazole 10 mg and     20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16     years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement     of the symptoms of GERD and to explore the relationship of symptom relief to dose received,     based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.   "
175009|NCT00132509|"     Data from the literature have suggested that a longer time of thrombolysis might be more     effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed     a randomized protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours.      Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60     minutes in the arm with a classical dose and 90 minutes in the arm with a low dose-longer     infusion.      This is a study of the outcome at 90 days.   "
175010|NCT00132522|"     This study is looking at the safety and tolerability of the experimental biological drug EMD     273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive     ovarian, prostate, colorectal or non-small cell lung cancers. EMD 273066 is an experimental     biological drug that may increase the immune response to certain cancers. Patients will be     enrolled in groups of 3, with each successive group receiving a higher dose if the prior     group adequately tolerates the study medication.   "
175011|NCT00132535|"     There is conflicting evidence regarding the influence of HIV infection on the success of     malaria prevention in pregnancy and effect on pregnancy outcome. The purpose of the proposed     study is to assess the impact of HIV infection on the effectiveness of malaria prevention     during pregnancy. This will be carried out by comparing two intermittent preventive     treatments (IPTs) with sulfadoxine/pyrimethamine (SP) plus 300 mg weekly chloroquine with two     doses IPT plus a weekly chloroquine placebo. The emphasis will be on assessing the effect of     chloroquine on HIV viral load and malaria morbidity and foetal outcome.      The study will be a randomised double-blind placebo-controlled trial with two arms, involving     pregnant women attending antenatal classes (ANCs) at health units, enrolled early in their     second trimester at 3 health units of the Mbarara district and Kampala. All pregnant women     presenting for antenatal care, irrespective of parity, who consent to participate will be     enrolled. Women with severe systemic disease or symptoms of AIDS will be excluded from the     study data analysis.      Women will be screened for HIV status and their HIV viral loads will be measured at     enrolment. Parasitaemia will be assessed at enrolment; at the beginning of the third     trimester; and at delivery. Haemoglobin will be measured at the same time points.      The main outcome variables to be assessed will be maternal peripheral parasitaemia; placental     parasitaemia; maternal clinical malaria; congenital parasitaemia; and maternal and neonatal     haemoglobin, birth weight and viral load at enrolment and before nevirapine administration to     the HIV positive mothers at birth.      Anthropological pre-studies to assess the quality of ANC services and healthcare seeking     practices of pregnant women in the study area will be carried out. Focus group discussions     (FGD) with pregnant women and mothers of neonates; in-depth interviews with relevant health     workers; and illness narratives from pregnant women will be used to collect data. The     anthropological study results will assist in appropriately planning for the trial to enhance     compliance to the intervention.      The data collection is planned to commence in August 2003 and is expected to end in October     2005. Twelve months will be spent on the write-up phase.   "
175330|NCT00135122|"     The purpose of this study is to determine whether prednisolone is more effective than placebo     in the first six days after initiation of medication withdrawal therapy for a medication     overuse headache. Another purpose is to study whether patients followed by a neurologist 1     year after withdrawal do better than patients followed by a general practitioner.   "
175012|NCT00132548|"     A recent study has shown that the administration of a single dose of     sulfadoxine/pyrimethamine plus artesunate to Senegalese children on three occasions during a     short malaria transmission season reduced the incidence of clinical attacks of malaria by     86%. However, use of this drug regimen led to the selection of parasites with molecular     markers of resistance to pyrimethamine and sulfadoxine. Therefore, a trial of three     alternative regimens has been undertaken to see if these are as effective and safe as the     drug combination used in the initial study but less likely to select for drug resistance.   "
175013|NCT00132561|"     In countries of the Sahel and sub-Sahel, malaria transmission is highly seasonal with nearly     all infections occurring during a few months of the year. However, mortality and morbidity     from malaria may be high during this period, especially in young children who are the group     most at risk.      Intermittent preventative treatment (IPT) is a new approach to the prevention of malaria in     this situation. IPT involves the administration of an anti-malarial to children at risk for     malaria at fixed times, even if they are not infected. To investigate how effective this     approach might be in Senegal, a trial has been undertaken in which 1136 children aged 6 weeks     to 59 months were given a single dose of sulfadoxine pyrimethamine and artesunate on three     occasions during a three-month rainy season and the incidence of clinical malaria in these     children was compared with that in a group of children who received placebo. Additional     observations were made on the incidence of side effects in children in the two groups and on     the impact of IPT in children (IPTc) on markers of drug resistance in children whose blood     films were positive for Plasmodium falciparum.   "
175014|NCT00132574|"     The purpose of this study is to determine whether minimizing the intake of milk and dairy     products will reduce the recurrence of acne among people who have been successfully treated     for acne with isotretinoin.   "
175015|NCT00132587|"     The aim of the study is to analyse and to compare the quality of fixation of a femoral     implant with or without cement.      One hundred thirty patients will be operated on and included with 2 groups, the first one     with TKA all cemented and the second one with TKA with a cementless femoral implant. The     study criteria include the IKS (International Knee Society) score and the analysis of a     radiolucent line at the femur.      Patients will be reviewed at 2, 6 and 12 months.   "
175023|NCT00132691|"     The purpose of this study is to compare the effectiveness of standardized systemic therapy     versus fluocinolone acetonide implant therapy for the treatment of severe cases of     non-infectious intermediate uveitis, posterior uveitis, or panuveitis.   "
175024|NCT00132704|"     Doctors will take some tissue from the tissue removed during surgery in order to study how     the blood vessels of the tumor respond to radiation therapy. The tissue obtained will be used     to determine how these tumor blood vessels respond to radiation therapy delivered to the     tumor, after it has been removed. This radiation is delivered in the research lab. This     research is being conducted in order to develop new methods to treat tumors by radiation     therapy. No additional surgery will be performed to obtain these samples, and only materials     that remain after all diagnostic testing has been completed will be used.   "
175025|NCT00132717|"     The purpose of this study is to investigate the effect of an investigational     cholesterol-lowering drug in patients who are currently taking an approved medication for     hypercholesterolemia (high cholesterol levels) and have been hospitalized for a heart     problem.   "
175026|NCT00132730|"     This is a study to evaluate the effectiveness and tolerability of a once-daily oral     medication (MK-0873) for the treatment of COPD (chronic obstructive pulmonary disease) to     determine whether the study drug leads to an improvement in pulmonary (lung) function, as     well as symptoms, and quality of life.   "
175027|NCT00132743|"     The purpose of this study is to compare the effectiveness of aortic stent surgery versus     exercise therapy in individuals with aortoiliac insufficiency.   "
175028|NCT00132756|"     The purpose of this research study is to test the safety, tolerability, and effectiveness of     the drug combination of Doxil (doxorubicin) and estramustine when used to treat prostate     cancer that is resistant to hormones and to a chemotherapy type called taxanes.      The primary hypothesis is to reduce the measurable disease or prostate-specific antigen (PSA)     level by at least 50% from baseline.   "
175029|NCT00132769|"     This study will look at whether this new drug is effective in the treatment of rheumatoid     arthritis, and at whether it is safe and well-tolerated by participants with the disease.   "
175030|NCT00132782|"     The purpose of this cross-sectional study was to determine the interrelationships between     health status and measures of cardiac performance in children 6 to 18 years of age with     congenital heart disease who have undergone a Fontan procedure as surgical treatment for     functional single ventricle. The goal was to develop a data set that will permit     identification of a clinically relevant endpoint for subsequent trials of medical management     of the Fontan patient.   "
175031|NCT00132795|"     The purpose of this study is to determine whether a telephone based self-help program will     prevent relapse among individuals undergoing standard substance abuse treatment.   "
175032|NCT00132808|"     Osteoporosis prevention is important in patients with osteopenia (low bone density). This     study will test the safety and efficacy of zoledronic acid in patients diagnosed with     osteopenia.   "
175033|NCT00132821|"     Smoking is a major health problem with a direct link to elevated heart- and lung-related     problems. Nicotine is highly addictive, which makes quitting difficult and relapse after     quitting highly probable. Any type of sleep disturbance may make quitting even harder. The     purpose of this study is to evaluate the effect of bupropion and nicotine replacement     therapies (NRT) on sleep disturbances. In turn, this might show how such medications affect     attempts at smoking cessation.   "
175078|NCT00133419|"     The purpose of the study is to see if giving vitamin and mineral supplements helps to protect     infants and children from diarrhea, which vitamins and minerals help to improve a child's     weight and growth, and if the same results occur in infants and children with HIV. HIV is the     virus that causes AIDS. Study participants will include 516 infants aged 4-6 months.     Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with     HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects     will have an equal chance of receiving one of three different vitamin and/or mineral     supplements during the study. Study procedures will include up to 7 blood samples and stool     samples every 3 months and body composition every 6 months. Participants will be involved in     the study for up to 18 months.   "
175034|NCT00132834|"     Current methods of measuring asthma severity can be problematic when used with children. A     measurement called exhaled breath condensates (EBC) may be a more useful way to determine     asthma severity in childhood. The purpose of this study is to determine if EBC measurements     are useful for determining asthma severity in asthmatic children as compared to currently     used laboratory measures.      Study hypotheses: 1) A broad panel of EBC measures will distinguish asthmatic children not on     inhaled corticosteroids (ICS) from both asthmatic children routinely taking ICS and     nonasthmatic controls. 2) Standardized equipment and methodologies for EBC collection,     processing, storage, shipping, and pH and mediator measurements can be developed that will     eliminate significant contamination from oropharyngeal saliva and allow for shipping and     processing at a central site.   "
175035|NCT00132847|"     The purpose of this study is to test and compare the allergenic effects of three commercially     available German cockroach allergen extracts in adults.      Study hypothesis: The biological potency of three commercially available German cockroach     allergy extracts can be compared using the ID50EAL method to standardize German cockroach     allergens.   "
175036|NCT00132860|"     The purpose of the study is to investigate,﻿ in patients with moderate to severe chronic     obstructive lung disease, whether intermittent antibiotic treatment leads to:        -  A slower rate of decline in forced expiratory volume in one second (FEV1);        -  A reduction in the frequency and severity of exacerbations;        -  Fewer hospital admissions for chronic obstructive pulmonary disease (COPD);        -  Lower mortality;        -  An improved quality of life as compared to a group of placebo treated patients.   "
175037|NCT00132873|"     This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the     OMC-SXB-7 open-label trial may be entered without any requirement as to length of     participation in that trial.      Approximately 70 patients are expected to participate at up to 6 investigative centers     located in Canada. The trial will continue for up to 24 months or until marketing approval,     whichever occurs sooner.   "
175038|NCT00132886|"     This study will look at how a single dose of study medication (tolvaptan) versus an inactive     sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure.     Higher than normal pressures can be related to symptoms of heart failure (shortness of     breath, fatigue, etc.).   "
175039|NCT00132899|"     The primary objective is to compare the efficacy and safety of infliximab plus methotrexate     to infliximab alone for the long-term control of signs and symptoms of Crohn's disease (CD)     in patients with symptoms that are persistent enough to require corticosteroid therapy.   "
175040|NCT00132912|"     The object of the study is to determine whether different doses of SCH 530348, when added to     standard medical care in persons undergoing percutaneous coronary intervention, will increase     the risk of bleeding.      A secondary objective is to determine whether patients treated with SCH 530348 have fewer     cardiac events such as heart attack, bypass surgery, or death compared with those persons     treated with the standard of care.   "
175041|NCT00132925|"     The purposes of this study are:        -  To demonstrate the efficacy of once daily administration of Nasacort AQ 110 µg compared          with placebo in children 2-5 years of age with perennial allergic rhinitis; and        -  To assess the safety of Nasacort AQ 110 µg in children 2-5 years of age.   "
175042|NCT00132938|"     Primary Objective:        -  The primary objective of the study is to demonstrate the superiority of telithromycin          over azithromycin and over cefuroxime axetil in the reduction of Streptococcus          pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure          (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit          1).      Secondary Objectives:      The secondary objectives of the study are:        -  To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime          axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit          in patients with Sp detected in sputum specimen at the start of the study (Visit 1);        -  To compare the clinical cure rates achieved by each treatment group in the penicillin or          erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp          (SSp) population at the End of Therapy (EOT) and Test of Cure visits;        -  To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of          Therapy visit on the presence of Streptococcus pneumoniae strains resistant to          beta-lactams or macrolides in the sputum of patients with Sp detected at the start of          the study (Visit 1);        -  To compare the clinical efficacy at the End of Therapy visit and safety at the Test of          Cure visit of telithromycin, azithromycin and cefuroxime axetil in the global          randomized population.   "
175043|NCT00132951|"     The purpose of this study is to determine if 1 course of antibiotic treatment with     telithromycin is superior to azithromycin in the treatment of lower respiratory tract     infections (LRTIs), acute exacerbations of chronic bronchitis (AECBs) and community-acquired     pneumonia (CAP) in the community setting.   "
175044|NCT00132964|"     Acute ankle fractures are common in children. Most of these are stable and have a low risk of     problems in the future. Even though these fractures are benign, these injuries are often     casted for a fixed time period, which is inconvenient, expensive, and does not appear to be a     practice that has been proven to be scientifically correct.      Therefore, in this study, in healthy children with low-risk ankle fractures, we, the     investigators at the Hospital for Sick Children, will examine if a removable ankle brace is     at least as good as casting with respect to how well and how fast children return to their     usual activities. In addition, we will compare the costs of each method for the patient and     the health care system.      Successful management of low-risk fractures with an ankle brace will allow for several     advantages over the use of the cast. These advantages include the possibility of returning to     normal activities faster, fewer visits to specialty hospital clinics, and significant cost     savings.   "
175097|NCT00133666|"     The purpose of this study is to determine if teaching children with asthma how to talk to     their doctor about controlling their asthma including symptom frequency in an asthma diary     and medication use techniques, will result in less symptom and missed school days, fewer     emergency room visits and reduce the cost of asthma health care.   "
175538|NCT00132171|"     Eradication rates of Helicobacter pylori (H. pylori) with standard triple therapy are     disappointing, and studies from several countries confirm this poor performance. The study     aimed to assess the eradication rate of a new sequential treatment regimen compared with     conventional triple therapy for the eradication of H. pylori infection.   "
175045|NCT00132977|"     Patients with heart failure have a pumping action of the ventricles in which one ventricle     contracts before the other ventricle. This uncoordinated (unsynchronized) pumping is due to a     delay in the stimulation of the left ventricle because of its increased size. Pacing both the     right and the left side of the heart (or cardiac resynchronization therapy [CRT]) has been     proven to be effective in the treatment of heart failure (HF). Current market-approved     devices combine both pacing (CRT) and shocking (implantable cardioverter defibrillator [ICD])     therapy for patients who have severe heart failure and are at risk for developing     life-threatening heart rhythms. These devices provide an electrical pacing stimulus to both     ventricles and may help the heart contract in a more coordinated way and improve heart     failure symptoms.      The investigational portion of this trial involves the implantation of a market-approved CRT     implantable cardioverter defibrillator (CRT-D) system in patients who do not meet the current     criteria for a CRT implant. In order to receive a CRT-D implant today, patients must have     heart failure symptoms, have a weakened heart muscle, and have uncoordinated pumping of the     heart. To demonstrate this uncoordinated pumping of the heart, a test (electrocardiogram     [ECG]) is done. It is believed that by using a different test (echocardiogram) to measure     whether this uncoordinated pumping is present, more patients will be identified that will     benefit from CRT-D therapy. This study will look at whether patients identified by using this     echocardiogram test show a benefit from having this CRT-D therapy.   "
175046|NCT00132990|"     The purposes of this study are:        -  to determine if bilateral pallidal deep brain stimulation results in improvement in neck          postures/movements;        -  to determine if bilateral pallidal deep brain stimulation results in improvement in          quality of life; and        -  to document the adverse effects of surgery in patients with cervical dystonia.   "
175047|NCT00133003|"     The purpose of this study is to determine whether there is any additional benefit from     abciximab administration during percutaneous coronary intervention in patients presenting     with acute coronary syndromes after pre-treatment with 600mg of clopidogrel.   "
175048|NCT00133016|"     The purpose of this clinical trial is to investigate the efficacy of early amniotomy on     reducing both the duration of labor and the frequency of dystocia in nulliparous women     undergoing an induction of labor. This research project is a prospective, parallel clinical     trial, in which subjects are randomized into one of two treatment groups: those who undergo     early amniotomy and those who do not undergo early artificial rupture of the amniotic     membranes.   "
175049|NCT00133029|"     The purpose of this study is to determine whether the timing of prophylactic antibiotic     administration for cesarean section (immediate preoperative versus intraoperative     administration) impacts the rate of postoperative febrile morbidity. The specific aim of the     project is to test the hypothesis that preoperative antibiotic administration will decrease     the rate of composite postoperative febrile morbidity.   "
175050|NCT00133042|"     The purpose of this study is to determine whether the addition of omalizumab in patients with     poorly controlled asthma (because of poor adherence) will decrease allergic airway     inflammation and improve asthma control.   "
175067|NCT00133276|"     The treatment of chronic hepatitis C with peginterferon and ribavirin is highly effective but     is hampered by peginterferon-induced psychopathology.      Prevention of peginterferon-induced psychopathology with selective serotonin reuptake     inhibitors (SSRI's) (paroxetine) has been shown to be effective in patients treated with     interferon for malignant disease. The aim is to study the effects of prophylactic treatment     with escitalopram (another SSRI) on peginterferon-associated psychopathology in patients     treated with peginterferon and ribavirin for chronic hepatitis C.   "
175051|NCT00133055|"     Sleep and discipline problems are the most common problems for parents of young children     (ages 2 to 5 years old) and are the two concerns with the strongest relations to future child     behavior problems. The Parenting Matters program combines treatment booklets and telephone     support to help parents deal with sleep or discipline problems. Parents with concerns and who     are interested in the study are identified during a visit to their family physician. We, the     investigators at the University of Western Ontario, expect that parents receiving treatment     booklets, along with usual care by their family physician, will have greater reductions in     their child's sleep or discipline problems, improved parenting practices, and greater     reductions in child behaviour problems after receiving the Parenting Matters intervention,     compared to parents receiving usual medical care.   "
175052|NCT00133068|"     A large number of African-American and low socioeconomic patients have poorly controlled high     blood pressure because of not being able to take their high blood pressure medications. This     puts these patients at higher risk of heart and kidney disease, stroke and death. This study     is designed to reduce the barriers that prevent patients from taking their high blood     pressure medications.   "
175053|NCT00133081|"     The purpose of this study is to assess whether changing antiepileptic medication can reduce     side effects and improve the quality of life in patients with epileptic seizures that are     well controlled with antiepileptic drugs.   "
175054|NCT00133094|"     Employing a physician-directed case management system, utilizing a Certified Registered Nurse     Practitioner (CRNP) in conjunction with computer-based decision support technology (CDST)     will result in significantly lower total cholesterol and a lower low density lipoprotein     cholesterol in a group of subjects enrolled in a general medical clinic compared to subjects     managed by primary care providers in the usual care group.   "
175055|NCT00133107|"     This study is to determine whether efalizumab 1.0mg/kg given by subcutaneous injection for 12     weeks is effective in treating oral lichen planus.      This is a 20 week, single center, open-label pilot study to enroll 5 subjects.   "
175056|NCT00133133|"     Postoperative pain after gall bladder removal can be significant, mobility limiting and     extend hospital stay. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine     that has the potential for long-term pain relief following a single administration. This     study will determine whether ALGRX 4975 can provide pain relief following gall bladder     removal.   "
175098|NCT00133679|"     The purpose of this study is to test if sildenafil is effective in the treatment of infants     with severe congenital diaphragmatic hernia (determined by the presence of prolonged     pulmonary hypertension or prolonged oxygen supplementation on mechanical ventilation), as     measured by the estimated pulmonary artery systolic pressure following treatment.   "
175057|NCT00133146|"     Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities     of an allergen extract to an allergic patient, is a curative approach which directly treats     the underlying allergic disease. GrassMATAMPL has been developed to provide pre-seasonal     specific immunotherapy for patients with an allergy to grass and rye pollen (hay fever).      The tolerability and immunogenicity of GrassMATA (allergen modified with glutaraldehyde and     adsorbed to tyrosine) with and without MPL adjuvant (monophosphoryl lipid A, extracted from a     bacterial cell surface) is being investigated in this double-blind, randomized Phase IIa     study in volunteers allergic to grass and rye pollen.      Additionally, this study will assess residual allergenicity of the modified grass and rye     pollen in the product GrassMATAMPL using skin prick testing in volunteers allergic to grass     and rye pollen.   "
175058|NCT00133159|"     Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities     of an allergen extract to an allergic patient, is a curative approach which directly treats     the underlying allergic disease. GrassMATAMPL has been developed to provide pre-seasonal     specific immunotherapy for patients with an allergy to grass pollen (hay fever). The purpose     of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of     different doses of GrassMATAMPL in volunteers allergic to grasses and rye pollen.   "
175059|NCT00133172|"     The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day     steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.   "
175060|NCT00133185|"     The primary objective of this trial is to compare the efficacy and safety of telmisartan 40     mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide     12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate     hypertension.   "
175061|NCT00133198|"     A 12 week clinical trial was conducted in the United States in order to compare pramipexole     (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in     adult subjects.   "
175062|NCT00133211|"     Atrial fibrillation is the most common heart arrhythmia afflicting approximately 1% of the     Danish population. Medical antiarrhythmic treatment is only moderately effective and has the     risk of severe side effects. The present study is a prospective, randomized, multicentre     study comparing medical antiarrhythmic drug strategy with catheter based radiofrequency     strategy in patients with paroxysmal atrial fibrillation. The primary end point is atrial     fibrillation burden (symptomatic and asymptomatic) judged by multiple 7-day Holter     monitorings during 2 years follow-up. Three hundred patients considered candidates for     antiarrhythmic drug treatment will be randomized. The study will be performed as a     Scandinavian/German multicentre study.   "
175063|NCT00133224|"     The primary objective of this study is to compare the duration of survival between patients     receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients     receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer     respond to hormone therapy, who have documented metastases with pain. Patients may have had     up to one prior non-taxane chemotherapy treatment.   "
175064|NCT00133237|"     The purpose of this study is to evaluate the efficacy of sirolimus- and paclitaxel-eluting     stents for treatment of unprotected left main coronary artery disease.   "
175065|NCT00133250|"     The purpose of this study is to assess whether abciximab is associated with additional     benefit in patients with AMI treated with PCI after high dose clopidogrel loading.   "
175066|NCT00133263|"     The purpose of this study is to evaluate the efficacy of Primary Bereavement Care (PBC) -a     standardized bereavement intervention- delivered by family physicians (FP), in widows.   "
175068|NCT00133289|"     The ULTRA study will assess the difference in average ventricular voltage output for     pacemaker patients randomized to Automatic Capture feature ON versus patients randomized to     Automatic Capture feature OFF.   "
175070|NCT00133315|"     The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients     who are being treated with TNFalfa blockers. By following the TNFalfa blocking treated     patients the researchers want to identify better biomarkers for disease activity and disease     progression. In addition, the researchers want to identify predictors for disease     progression.   "
175071|NCT00133328|"     The JIKEI HEART Study has been designed to investigate whether concomitant treatment with     valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment,     will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.   "
175072|NCT00133341|"     It is the purpose of this study to determine the concentration of 3 allergens     (goldnatriumthiosulphate, methyldibromoglutharonitrile [MDBGN], parthenolide) for diagnosing     allergic contact dermatitis.   "
175073|NCT00133354|"     The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay epiphyseal     fusion and increase predicted adult height in boys who are growth hormone deficient, in     puberty, and who are taking growth hormone. This is a double blind, placebo controlled 3 year     trial.   "
175074|NCT00133367|"     The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and     sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy     followed by donor cord blood transplantation.   "
175075|NCT00133380|"     The purposes of this study are to determine:        -  The safety of the study medication and any side effects that might be associated with it        -  Whether the study medication can help patients with high levels of bad cholesterol          (low-density lipoprotein-cholesterol [LDL-C]), alone or in combination with additional          study medication   "
175076|NCT00133393|"     The primary objectives of this study is to identify a safe, tolerable dose of pentoxifylline     in children with cerebral malaria and to establish an acceptable pentoxifylline dosage     regimen for use in multi center Phase II and Phase III studies.   "
175077|NCT00133406|"     The primary objectives of this study are to determine the effect of 1 year supplementation of     Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score     (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in     children living in a Brazilian slum. Study participants will include 280 children ages 2     months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque     Universitario community, living in Brazilian favela. There is also a sub study to determine     if ten days of glutamine delivered as an oral bolus improves the health of the digestive     system.   "
175079|NCT00133432|"     Undernutrition in children less than five years of age is common throughout sub-Saharan     Africa. Nutritional deficiencies may lead to less ability to fight infectious diseases. The     purpose of this study is to determine whether zinc supplements plus standard antibiotics     reduce the length of hospitalization in children with pneumonia. Six hundred children aged     6-36 months diagnosed with pneumonia and admitted to Muhimbili National Hospital (MNH), Dar     es Salaam, Tanzania, will participate in this study. Half of the children will receive daily     supplements of zinc, and the other half will receive placebo tablets (dummy pills containing     no medication). Each child will be followed for 6 weeks after hospital discharge to check for     recovery from the illness. All children in both groups will receive antibiotics and     supportive care to manage pneumonia, according to the standards of care at MNH and Amana     Municipal Hospital in accordance with the Recommendations of the Ministry of Health,     Tanzania.   "
175080|NCT00133445|"     The purpose of this study is to evaluate the safety of administering a combination vaccine     (DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration     of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age.     Additionally, researchers will assess the body's antibody response (proteins produced by the     body's immune system that help fight infections) following each vaccine dose. The study will     enroll 5 healthy newborns, ages 0-5 days. Participants will be involved in study related     procedures for up to 288 days, including blood sample collection and 5 study visits.   "
175081|NCT00133458|"     This study will enroll 120 individuals diagnosed with subarachnoid cysticercosis, a disease     caused by the invasion of the basal part of your brain by a parasite named Taenia solium.     Subarachnoid cysticercosis is usually treated with albendazole for one month to kill the     parasite. This study will determine if two months of albendazole (ABZ) therapy is better than     one-month. The study will last 3 years.   "
175082|NCT00133471|"     The purpose of this study is to compare the body's reactions and immune responses after     receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant     given into the arm muscle. Study participants will include up to 96 healthy adults, ages     18-34. The 4 dosages of the experimental H9N2 vaccine to be tested in this study are the     following: 3.75, 7.5, 15, and 30-mcg (with and without MF59 adjuvant). Participants will be     vaccinated on Days 0 and 28. Participants will record any vaccine side effects in a diary for     7 days following each vaccination. Participants will return to the clinic on days 2 and 7     after vaccination. Blood samples will be collected 7 days following each vaccination. Serum     and nasal wash specimens will be collected before each vaccination and 4 weeks after     injections (0, 4, and 8 weeks). Participants will be involved in study related procedures for     up to 8 months.   "
175105|NCT00133770|"     The aim of this study is to examine whether pantoprazole (Protonix) given through continuous     intravenous infusion for 72 hours is superior to Protonix given through once a day IV     injection in the treatment of erosive esophagitis.   "
183161|NCT00240838|"     The purpose of this study is to compare the effectiveness and safety of acetaminophen     extended release caplets and ibuprofen in relieving the muscle soreness that occurs after a     marathon.   "
175083|NCT00133484|"     Objectives are: To confirm the safety and tolerability of 2-dose regimens of 100 g rPA     vaccines (3 products) administered by the intramuscular (IM) route to healthy adults.To     describe the immunologic responses to 2-dose regimens of 3 rPA vaccines and to compare the     responses to those following administration of Anthrax Vaccine Adsorbed (AVA or BioThraxTM),     the currently available vaccine. The primary immunologic outcome is the proportion of     volunteers in each group that mounts an antibody response (defined as a 4-fold or greater     increase from pre-vaccination to post-vaccination of anti-rPA IgG antibody with a minimal     concentration of 10 µg/ml as measured by ELISA). Secondary outcomes are time to peak response     and GMC of anti-PA antibody at peak for each group. In addition, the following immunologic     assays will be performed: toxin neutralization assay, oral fluid ELISA, antibody avidity, IgG     subclasses, and B-cell memory,T-cell memory and effector subpopulations.   "
175084|NCT00133497|"     The purpose of this research study is to test the safety of and the body's response to an     experimental cytomegalovirus (CMV) vaccine (called gB/MF59 vaccine). Participants will     include approximately 400 healthy females, ages 12-17, recruited from adolescent clinics at     Cincinnati Children's Hospital Medical Center, Vanderbilt University Medical Center, Baylor     College of Medicine, University of Texas School of Public Health, Houston, and the University     of Texas Medical Branch at Galveston. Participants will receive 3 doses of vaccine or placebo     (saltwater) on a 0, 1, and 6 month schedule. Study procedures will include blood and urine     samples. Participants will complete a diary recording temperatures and any side effects     experienced. Subjects will be involved in study related procedures for up to 31 months.   "
175085|NCT00133510|"     The purpose of this study is to evaluate how well children responds to the recommended     trivalent subviron influenza vaccine (flu shot). Children who have had a liver transplant and     receive their post-transplant care at Mount Sinai and their siblings are being invited to     participate in this study. Study procedures will include a review of medical records,     physical examination, and up to 2 flu shots. All participants will receive the flu vaccine.     Four weeks after the first flu shot, participants will return to the clinic for a physical     exam, blood sample collection, and a second flu shot as recommended. Following each     vaccination, parents will be asked to record their children's temperatures and any     experienced side effects in a diary card for two weeks. Participants will be involved in     study related procedures for up to 8 months.   "
175086|NCT00133523|"     The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo     (inactive substance). The study will be conducted among healthy adult participants aged 18-49     years and is expected to last 3 years. During year 1, participants will be assigned to     receive 1 of the 2 licensed flu vaccines or placebo, given as either nasal spray     (live-attenuated vaccine or placebo) or injection (inactivated vaccine or placebo).     Participants will receive the same assigned vaccine or placebo during year 2. During year 3,     participants will be followed, but will not receive flu vaccine. Each year blood samples will     be collected before and 1 month after each vaccination and at the end of each flu season in     order to measure how the body responds to the vaccine and how well participants were     protected from the flu. During the flu season, participants with flu-like illness will     provide information on symptoms and provide a throat swab to test for virus identification.   "
175087|NCT00133536|"     The purposes of this study are: to make sure that there are no serious side effects of an     experimental inactivated influenza A/H5N1 vaccine in children; and to see how the body's     immune system reacts to the vaccine. To look at the side effects, researchers will follow     children closely after vaccination. To look at immune system responses, researchers will test     the children's blood before and a number of times after vaccination. Participants will     include up to 130 healthy children ages 2-9 years. Participants will be assigned to receive     2, up to 3 doses of vaccine, or placebo (inactive substance). Subjects will receive at least     2 doses of vaccine approximately 28 days apart. If data shows an enhanced immune response     from a third vaccination, children will be offered a third dose of the vaccine. Participants     will be involved in study related procedures for up to 13 months, including up to 6 study     visits, plus a number of telephone calls.   "
175088|NCT00133549|"     The purpose of this study is to evaluate the safety and immune response of a conjugated     pneumococcal vaccine compared to a licensed 23-valent polysaccharide pneumococcal vaccine in     elderly adults. Study participants will include 180 adults, 65 years of age or greater.     Participants will be randomly assigned to 1 of 3 possible groups. Subjects will maintain a     study diary to record side effects and oral temperatures for 7 days following each     vaccination. Blood samples will be collected before and 1 month following each dose of     vaccine or placebo. Participants will be involved in study related procedures for up to 268     days.   "
175089|NCT00133562|"     This study will determine the effect of 7 days supplementation of alanyl-glutatime or glycine     on the damaged intestinal barrier function on day 8 in children with persistent diarrhea or     malnutrition.   "
175090|NCT00133575|"     The purpose of this study is to assess the safety of an experimental smallpox vaccine (MVA:     Modified Vaccinia Ankara) and to compare the body's immune (system that fights disease)     response to this vaccine. Participants will be assigned to 1 of 6 study groups. Each group     will include 12 subjects, 10 will receive the modified smallpox vaccine and two will receive     placebo, an inactive substance. The vaccine will be administered in 1 of 3 ways: under the     skin; in the muscle; or between the muscle and the skin. Groups A and B will receive Dryvax®     6-15 months after the initial MVA vaccine; groups C, D, E, and F will receive Dryvax® 6     months after the initial MVA vaccine. Study procedures will include documenting side effects     for 14 days after each vaccination, electrocardiogram (picture of the hearts activity) and     blood samples. Participants will be involved in study related procedures for up to 18 months.   "
175119|NCT00133952|"     The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin     will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with     clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from     baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity     that is sustained for the patient's last 6 months of study participation. The SMVL data from     this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of     comparing ruboxistaurin to placebo.   "
183774|NCT00248781|"     This study is investigating the effects of a home-based resistance exercise program,     administered via an interactive telecommunications system, in functionally limited older     veterans.   "
175091|NCT00133588|"     The purpose of this study is to evaluate a new method of detecting the flu infection. This     method may allow researchers to identify new proteins being made in response to an infection     even before symptoms of the infection are present. The goal of this study is not to prevent     the flu but to monitor the immune system response. The elderly and those with chronic health     problems are at greater risk for complications (i.e., pneumonia, bronchitis [bacterial     infection in the lungs], and sinusitis [bacterial infection in the sinuses]) from the flu.     Early detection and diagnosis of the flu decreases the number of people with these     complications. Participants will include healthy people between the ages of 21-40, between     the ages of 60-89, or 90 years and older, who are living in the communities surrounding the 3     study sites in Virginia. There will be 5 study visits, and subjects will participate up to 1     month.   "
175092|NCT00133601|"     This study of cognitive behavioral therapy for insomnia in chronic pain patients is a     randomized, controlled clinical trial of parallel groups with three and six months follow up.   "
175093|NCT00133614|"     The purpose of this trial is to test the hypothesis that at the end of 28 days, infants and     children with acute lung injury treated with prone positioning would have more     ventilator-free days than those treated with supine positioning.   "
175094|NCT00133627|"     Medications available for the treatment of seasonal allergic conjunctivitis include     antihistamines. These medicines block the release of histamine, a substance in the body that     is released when an allergic reaction occurs. Novartis (NVS) has developed an eye drop     formulation of a well tried antihistamine called ketotifen. This study will compare the     efficacy and the tolerability of ketotifen eye drops with emedastine, which is a popular     treatment for seasonal allergic conjunctivitis in China.   "
175095|NCT00133640|"     The aim of this study is to compare a low versus high intensity physiotherapy early     rehabilitation program combined with a low versus high dose vitamin D early rehabilitation     program in a randomized controlled trial among elderly patients with acute hip fracture in an     acute care setting. The primary outcome to be compared between treatment arms is the rate of     falls during a 12-month follow-up. Secondary outcomes are injurious falls, number of persons     who fell, low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur,     tibia), disability, quality of life (Euro-Qol), mortality and health care utilization.     Another secondary outcome will be admission to nursing home compared between treatment arms     among subjects, who are community-dwelling prior to the index hip fracture. Admission to     nursing home is the marker of loss of independence for the individual, but also triggers high     cost for the society.      The study will provide new early rehabilitation guidelines to allocate health care resources     efficiently in the acute care setting. Eventually and most importantly, the study will help     improve outcomes in patients with hip fractures.   "
175096|NCT00133653|"     Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have     previously been associated with a sustained increase in blood pressure (BP).      In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we, the     researchers at Sunnybrook and Women's College Health Sciences Centre, evaluated whether JS     and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in     subjects enrolled with normal or untreated high BP.   "
175099|NCT00133692|"     Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is     important to keep it as normal as possible. There are several different ways to control blood     pressure and to prevent or limit the development of heart disease due to high blood pressure.     The purpose of this study is to compare two treatments to see how well they work and the     difference in their side effects. One treatment includes the use of a calcium antagonist drug     (Isoptin sustained release [SR] or Verapamil SR). The other treatment excludes the calcium     antagonist and may include a non-calcium antagonist drug called a beta blocker (Tenormin or     Atenolol). Both treatments may also include medication called angiotensin converting enzyme     (ACE) inhibitors and water pills. None of the drugs in this study are experimental, they are     all approved by the Food and Drug Administration (FDA).   "
175100|NCT00133705|"     The purpose of this trial is to determine if low-dose mifepristone benefits women with     symptomatic fibroids.   "
175101|NCT00133718|"     The purposes of this study are:        -  to investigate the extent of cardiovascular complications in a representative cohort          (n=135) of adult patients with type 2 diabetes;        -  to examine if modern non-invasive assessment can replace invasive assessment;        -  to determine the effects of a 6 month lifestyle interventional program on weight,          glycemic control and lipids in 60 patients;        -  to determine the effect of a 2-year prospective, randomised multi-interventional program          (n=120) on cardiovascular risk, anthropometric measures and glycometabolic control; and        -  to investigate inflammatory markers in this setting.   "
175102|NCT00133731|"     The objective of this dose-ranging study is to determine the effects of several intravenous     (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and     coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.   "
175103|NCT00133744|"     The purpose of this study is to determine whether a daily prenatal supplement of iron plus     folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women     from their first prenatal visit through delivery reduces perinatal mortality compared with a     daily prenatal supplement of folic acid alone.   "
175104|NCT00133757|"     In this study we, the investigators at the Centre for Addiction and Mental Health, intend to     explore whether bupropion is able to reduce smokers' responses to cigarette-related     environmental cues, and craving. Previous studies have indicated that bupropion may be able     to achieve these outcomes. Therefore, we predict that smokers treated with bupropion for     several weeks will show reduced reactivity to cigarette cues and craving.   "
175106|NCT00133783|"     Calcitonin, calcitonin gene-related peptides (CGRPs), adrenomedullin, and amylin belong to a     unique group of peptide hormones important for the regulation of calcium balance,     neurotransmission, cardiovascular homeostasis, and glucose metabolism. We, the investigators     at Chang Gung Memorial Hospital, recently identified intermedin as a novel peptide hormone     belonging to this unique peptide ligand family. Adrenomedullin is a 52-amino-acid peptide and     is one of the most potent vasodilators. Plasma adrenomedullin is elevated in a variety of     pathological conditions such as hypertension, renal failure, heart failure, and septic shock.     CGRPα and CGRPβ are 37-amino acid neuropeptides; primarily release from sensory nerves; and     play important roles in regulating peripheral vascular tone and controlling blood flow in     various organs. Human mature intermedin encodes 40-amino-acid and is expressed mainly in the     adrenocorticotrophs of the anterior and intermediate pituitary lobe. Intermedin signals     through calcitonin receptor-like receptor (CRLR)/receptor activity-modifying protein (RAMP)     receptor complexes, and CRLR/RAMP signaling has been proven to be critical for vascular tone     regulation. Based on this finding, we had documented that intraperitoneal administration of     intermedin dose-dependently suppressed blood pressure in normal Sprague-Dawley rats. In     addition, our preliminary in vitro and in vivo studies demonstrated that ovariectomy lead to     a tenfold reduction of intermedin transcript expression in the pituitary in rats whereas     subsequent estrogen treatment increased pituitary intermedin expression to a level similar to     that of intact rats. Taken together, we propose that pituitary-derived intermedin is     regulated by estrogen and exhibits potent hypotensive effects. To address this hypothesis, in     Specific Aim 1, we will investigate the regulation of secretion and expression of intermedin     in vitro and in vivo using cultured pituitary cells and oophorectomized rats. In Specific Aim     2, we will study the molecular mechanism by which estrogen stimulates intermedin gene     expression. In Specific Aim 3, to demonstrate that the estrogen-dependent regulation of     intermedin represents a critical link in the regulation of blood pressure in women, we will     study the relationship between blood pressure and blood intermedin levels using a     cross-sectional study. Our studies will provide a better understanding of the mechanisms by     which sex hormones modulate blood pressure and open a new window for postmenopausal     hypertension treatment.   "
175107|NCT00133796|"     The purposes of this study are to better understand how Herceptin causes tumors to become     smaller and to find out how effective Herceptin, together with chemotherapy, is in treating     advanced breast cancer.   "
175108|NCT00133809|"     This trial will study the ability of islet transplantation to restore glycemic control and     achieve insulin independence in type 1 diabetic subjects with life-threatening hypoglycemia     and unawareness, or recurrent hyperglycemia with ketoacidosis.   "
175109|NCT00133822|"     The purpose of this study is to determine whether the administration of risperidone is     effective in the treatment of selective serotonin reuptake inhibitor (SSRI)-resistant     post-traumatic stress disorder (PTSD) in civilians.   "
175110|NCT00133835|"     Endoscopy is an established method of treatment for painful obstructive calcified     pancreatitis. It involves the disintegration of calcifications using extracorporeal shock     wave lithotripsy (ESWL) followed by endoscopic removal of stone fragments possibly associated     with stent insertion. A pilot study suggests that ESWL alone relieves pain in calcified     chronic pancreatitis (CP). The aim of this study is to compare both techniques in a     randomized controlled trial.   "
175111|NCT00133848|"     The goal of this study is to determine if topical SB-275833 ointment, 1% is more effective     than a placebo ointment in the treatment of primary impetigo.   "
175112|NCT00133861|"     The aim of the study is to confirm the functional improvement obtained through treatment of     spasticity on 2 agonist and antagonist muscles. The hypothesis is that treatment of both     muscles gives a better and longer functional improvement than treatment of only one muscle.     The target muscles are the rectus femoris and semitendinosus and the treatment is botulinum     toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level,     functional scales and subjective feeling) and gait analysis data (kinematics and kinetics     data) are collected. Evaluations take place before treatment, 2 months and 6 months after     treatment.   "
175113|NCT00133874|"     The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and     effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and     children as young as 9 months of age.   "
175114|NCT00133887|"     In a population of kidney transplant recipients having developed a first squamous cell     carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2     years in patients who are switched to rapamycin as compared to patients who are maintained     under calcineurin inhibitors.   "
175115|NCT00133900|"     This study enrolled men with prostate cancer who had failed hormone therapy (as shown by     rising prostate-specific antigen [PSA] levels) and who were about to start a new line of     chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly     thereafter for up to 18 months or until disease progression, whichever occurred first. The     blood was tested to find circulating tumor cells (CTC) and to count them. The circulating     tumor cell levels were studied in relation to the patient's overall survival. Serum was also     collected for PSA testing, and additional blood samples were drawn to test for circulating     endothelial cells and RNA was isolated for future gene expression testing.   "
175116|NCT00133913|"     This study enrolled patients with measurable metastatic colorectal cancer. Blood was drawn     prior to the patient receiving a new therapy for his/her cancer and subsequently at 7-14     days, 3-4 weeks, and when an imaging study was done (~every 6 to 12 weeks). The blood was     tested to find circulating tumor cells (CTCs) and to count them. The CTC levels were compared     to the imaging study results to see if the CTC number and the imaging result (progression/no     progression) were in agreement. Maximum active study participation was 12 months with up to 8     blood draws being taken. All patients are currently being followed for up to 24 months from     their off study date for survival. The CTC result will also be used to see if there is a     difference in survival and progression-free survival for those patients with and without a     certain number of CTCs.   "
175117|NCT00133926|"     The aim of the study is to investigate, in an Australian population of pregnant women,     whether the treatment of periodontal disease during pregnancy prevents pre-term birth and     other complications of pregnancy. Dental screening and periodontal treatment protocols have     been based on standard techniques employed by hygienists that can be readily applied to the     general obstetric population.   "
175118|NCT00133939|"     Synchronism of gas flow delivered by the ventilator and muscular effort of the patient will     be studied during two kinds of ventilation. The first one is the proportional assisted     ventilation during which the gas flow is theoretically adapted to the patient's muscular     effort within the breath. The second is the pressure support ventilation during which the gas     flow is delivered to maintain the inspiratory pressure stable. The hypothesis is that the     first mode allows a better synchronism.   "
175161|NCT00134511|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      To evaluate the efficacy and safety of the lipid drug Torcetrapib/atorvastatin in patients     with genetically known disorder of extremely high cholesterol   "
175120|NCT00133965|"     This is an international, 3-site trial (Winnipeg Canada, MSKCC NYC, Perth Australia) accruing     120 patients per site (120x3). The purpose of this study is to compare two types of     counseling for cancer patients: Dignity Psychotherapy and Supportive Psychotherapy as     well as Standard Palliative Care. Many cancer patients seek counseling to help with the     emotional burden of their illnesses. Counseling often helps them cope with cancer by giving     them a place to express their feelings. We, the investigators at Memorial Sloan-Kettering     Cancer Center, have developed a type of counseling we call Dignity Psychotherapy. It is     intended to help cancer patients maintain or enhance a sense of purpose, meaning, and overall     quality of life, despite having cancer. Supportive Psychotherapy is another type of     counseling intended to help patients feel more at ease and express and reflect on any     feelings or concerns they might have about their illness. Both of these types of counseling     will be compared to Standard Palliative Care. We will look at how these types of treatments     affect patients' mood, outlook, and quality of life. We also want to see how the type of     treatment they receive affects their family members and significant others.   "
175121|NCT00133978|"     The purpose of this study is to determine whether providing high dose glutamine and     antioxidants to critically ill patients will be associated with improved survival.   "
175122|NCT00133991|"     RATIONALE: Drugs used in chemotherapy, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. Giving combination chemotherapy together with rituximab may kill more     cancer cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with rituximab works in treating patients with newly diagnosed Burkitt's lymphoma or     leukemia.   "
175123|NCT00134004|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and     radiation therapy before a donor bone marrow transplant helps stop the growth of cancer     cells. Giving chemotherapy or radiation therapy before or after transplant also stops the     patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem     cells may replace the patient's immune system cells and help destroy any remaining cancer     cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also     make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate     mofetil after the transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide     together with total-body irradiation works in treating patients who are undergoing a donor     bone marrow transplant for hematologic cancer.   "
175124|NCT00134017|"     RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of     cancer and abnormal cells and helps stop the patient's immune system from rejecting the     donor's stem cells. When the healthy stem cells from a donor are infused into the patient     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,     and platelets. Sometimes the transplanted cells from a donor can make an immune response     against the body's normal cells. Giving cyclophosphamide, mycophenolate mofetil, or     tacrolimus after transplant may stop this from happening.      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together     with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a     donor bone marrow transplant for hematologic cancer.   "
175331|NCT00135135|"     This is a phase II window study of the combination of ZD1839 (gefitinib) and irinotecan in     children with high-risk neuroblastoma followed by standard induction chemotherapy,     intensification with autologous stem cell transplantation, and an oral maintenance phase with     13-cis-retinoic acid and topotecan. We hypothesize that the ZD1839 (gefitinib) and irinotecan     window will be efficacious.   "
175125|NCT00134030|"     This randomized phase III trial is studying combination chemotherapy followed by surgery and     two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to     compare how well they work in treating patients with osteosarcoma. Drugs used in chemotherapy     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with     the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the     tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon     alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving     combination therapy together with PEG-interferon alfa-2b is more effective than two different     combination chemotherapy regimens alone after surgery in treating osteosarcoma.   "
175126|NCT00134043|"     This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating     patients with metastatic and/or locally advanced or locally recurrent thyroid cancer. Drugs     used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth.   "
175127|NCT00134056|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective     than docetaxel and prednisone in treating prostate cancer.      PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to     see how well they work compared to docetaxel and prednisone in treating patients with stage     IV prostate cancer and bone metastases that did not respond to previous hormone therapy.   "
175128|NCT00134069|"     This phase I/II trial is studying the side effects and best dose of sorafenib when given     together with cetuximab and irinotecan and to see how well they work in treating patients     with advanced or metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances     to them. Sorafenib and cetuximab may also stop tumor growth by blocking blood flow to the     tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to kill tumor     cells, either by killing the cells or by stopping them from dividing. Giving sorafenib     together with cetuximab and irinotecan may kill more tumor cells   "
175129|NCT00134082|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as cyclophosphamide, work in different ways to stop the growth of cancer cells either by     killing the cells or by stopping them from dividing. Vaccines made from another person's     cancer cells may help the body build an effective immune response to kill cancer cells.     Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells      PURPOSE: This phase I/II trial is studying how well giving rituximab together with     cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin     lymphoma.   "
175130|NCT00134095|"     RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.     Giving chemotherapy before surgery may shrink the tumor so that it can be completely removed.      PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works     in treating patients who are undergoing surgery for locally advanced stomach cancer.   "
175131|NCT00134108|"     The purpose of this study is to conduct a formal controlled evaluation of the potential     benefits of CBT for insomnia in cancer patients.   "
175132|NCT00134134|"     The purpose of this study is to determine the effectiveness and safety of efalizumab in     treating hydradenitis suppurativa, and to evaluate the duration of the benefit seen in people     who respond to treatment with efalizumab, after the medication is stopped.   "
175133|NCT00134147|"     To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes     who are not well controlled on 2 or more oral anti-diabetic agents   "
175134|NCT00134160|"     The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker     (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more     effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk     hypertensive patients not adequately controlled by standard dose ARB alone.   "
175135|NCT00134173|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      To look at ultrasound images taken in the blood vessels of the heart and to look at various     lipids in the blood of people with known coronary heart disease   "
175136|NCT00134186|"     The purpose of this study is to find out if renal cell (kidney) cancer that has spread to     other parts of the body will respond to treatment with motexafin gadolinium (MGd).   "
175137|NCT00134199|"     To evaluate the effect of 6-month administration of CP-945,598 on:        -  weight loss and waist circumference,        -  blood pressure, cholesterol, glucose        -  other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-Î±          and hsCRP        -  the relationship between the concentration of the drug on the blood and the above          parameters        -  physical and psychosocial functioning, weight related symptoms, treatment satisfaction,          appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression   "
175332|NCT00135148|"     Participants fill out a questionnaire on libido and their possible partner relationship.      A blood sample is taken for sex steroid analysis.   "
175539|NCT00132184|"     The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's     disease.   "
175606|NCT00140946|"     A study to assess the clinical effect of montelukast sodium with concomitant administration     of inhaled budesonide in asthmatic patients.   "
175138|NCT00134212|"     In septic shock, when volume resuscitation fails to restore mean arterial pressure,     catecholamines such as dopamine, dobutamine, epinephrine, or norepinephrine are used, either     alone or in combination. Although they allow hemodynamic success to be obtained, they can     leave some regional blood flows impaired, especially the hepatosplanchnic perfusion, which     contributes to multiple organ failure.      Dopexamine is a structural and synthetic analog of dopamine that exerts systemic and gut     vasodilation and stimulates cardiac contraction. In experimental models, dopexamine has been     shown to exert anti-inflammatory properties and to protect the hepatic ultra structure. The     combination of dopexamine and norepinephrine could therefore constitute an interesting     alternative in treating septic shock patients. This study will test the efficacy (on gastric     mucosal blood flow, hepatic damage and oxidative stress) and safety of the combination of     dopexamine and norepinephrine (compared to those of epinephrine alone) in the treatment of     patients with septic shock.   "
175139|NCT00134225|"     The investigators hypothesize that non able-bodied participants with reported acute,     sub-acute, or chronic symptoms of neck or back pain of a musculoskeletal origin will have     magnetic resonance imaging (MRI), X-ray and blood parameters that do not demonstrate a     statistical difference between “normal” (able-bodied) volunteers.      Muscle pattern recognition (MPR) testing will show statistically different results between     these groups. This statistically significant finding in MPR results will enhance a     clinician’s determination of clinical normality or abnormality.      If this hypothesis is demonstrated, the MPR modality will be the first quantitative tool     developed for assisting in the diagnosis of the presence or absence of a musculoskeletal     dysfunction in a patient population. The availability of such an evaluation tool to a     healthcare provider for patients with soft tissue, non-surgical neck or back complaints will     substantially improve the accuracy of diagnosis and case management decisions.   "
175140|NCT00134238|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      To look at ultrasound images taken in the carotid arteries and to look at various lipids in     the blood of people with mixed hyperlipidemia   "
175141|NCT00134251|"     This study is a multicenter, randomized, double-blind, placebo controlled, parallel group     study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in     patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations.     Patients (outpatients) will be randomized to one of three different treatment arms.   "
175142|NCT00134264|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      To demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular     disease events, when compared to atorvastatin alone, in patients with coronary heart disease     or risk equivalents   "
175143|NCT00134277|"     This study is a comparison of different medical devices for infragenual dilatation.   "
175144|NCT00134290|"     This is a study to:        -  Determine the difference between strong hypo-energetic standard diet advice and modest          hypo-energetic personal diet advice; and        -  Determine the influence of insulin-insensitivity on obesity and weight reduction by          treating patients with metformin or placebo.   "
175145|NCT00134303|"     This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery     for obesity.   "
175146|NCT00134316|"     Aim #1. To investigate the efficacy of the psychoeducational intervention (PED) on sexual     arousal.      H1: Compared to a control group and to baseline, PED will result in significant improvement     in:        -  self-reported subjective sexual arousal;        -  self-reported genital sensitivity;        -  psychophysiological sexual arousal.      Aim #2. To investigate the efficacy of the PED on self-reported orgasm, sexual desire,     distress, and relationship satisfaction.      H2: Compared to a control group and to baseline, PED will result in significant improvement     in self-reported orgasmic experience, sexual desire, sexual distress, and relationship     satisfaction.      Aim #3. To investigate the efficacy of the PED on depressive symptoms and quality of life.      H3: Compared to a control group and to baseline, PED will result in significant improvement     in self-reported depressive symptoms and quality of life.   "
175147|NCT00134329|"     This study consists of filling out a questionnaire on possible erectile dysfunction.   "
175148|NCT00134342|"     The tuberculin skin test (TST) has been the gold standard for diagnosing latent tuberculosis     for almost 100 years. While this test performs reasonably well in healthy, non-bacille     Calmette-Guerin (BCG) vaccinated populations, it is believed to perform less well in patients     who do not have intact cellular immune systems (immunocompromised).      The investigators hypothesize that a new test, the T-SPOT TB ELISPOT test will provide a more     accurate measurement of latent infection in immunocompromised people. This study will compare     the TST to the T-SPOT TB ELISPOT test, and to the results of an expert physician diagnostic     panel.   "
175149|NCT00134355|"     The purpose of this study is to evaluate PTK787/ZK 222584, a drug that blocks new blood     vessel growth, in the treatment of patients with non-metastatic androgen independent prostate     cancer. This study will assess the safety and tolerability of PTK787/ZK 222584, and evaluate     serum vascular endothelial growth factor (VEGF) levels.   "
175150|NCT00134368|"     The purpose of this study is to investigate the efficacy and safety of etanercept in adults     with vitiligo.   "
175151|NCT00134381|"     The purpose of this study is to investigate whether topically applied constituents of green     tea [caffeine or (-)-epigallocatechin gallate; EGCG] have a protective effect on skin exposed     to ultraviolet light (UV).   "
175152|NCT00134394|"     The study is designed to evaluate the efficacy of etanercept 50 mg subcutaneously (SQ) weekly     plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus     placebo ointment twice daily.   "
175203|NCT00127712|"     The investigators hypothesize that the medication amiodarone decreases the incidence of     atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are     to:        -  Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac          open-chest surgery;        -  Determine the influence of the prevention of AF following non-cardiac thoracic surgery          on post-surgical duration of stay in the Intensive Care Unit (ICU); post-surgical          duration of stay in a hospital unit that employs cardiac monitoring; and duration of          post-surgical hospital stay; and        -  Determine the safety of amiodarone for the prevention of AF following non-cardiac          open-chest surgery.   "
175153|NCT00134407|"     Complete fasting until resumed bowel function after upper abdominal surgery is not     beneficial. Enteral feeding has been claimed to be the preferred way of delivering     nutritional support postoperatively. Increasing evidence suggests that letting patients eat     (voluntary oral feeding or oral intake at will) from the day after the operation is safe.     No prospective randomised trial has been undertaken to compare these two regimens. In this     study, the investigators will randomise 444 patients, subject to major upper abdominal     surgery, into receiving either continuous enteral feeding by needle catheter jejunostomy     until resumed bowel function, or to oral intake at will from postoperative day 1. The main     endpoints are the incidence rate of major complications and death, as well as a Quality of     Life assessment.      Null-Hypothesis:      Routine postoperative feeding by needle catheter jejunostomy after major, upper abdominal     surgery has no clinically relevant advantages over early oral intake at will.   "
175154|NCT00134420|"     We, the investigators at the University of Texas Health Science Center at San Antonio, want     to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH)     treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous     study showed that growth hormone improved height in all children with 18q- and growth hormone     deficiency. In addition, most of the study participants on growth hormone treatment showed an     increase in IQ scores.   "
175155|NCT00134433|"     Coronary artery disease is the single most important killer of Canadians. Despite major     advances in therapy, there is still a significant proportion of patients identified with the     disease who die of it because current treatment approaches cannot effectively palliate their     condition. A new treatment modality called therapeutic angiogenesis has appeared on the     clinical research scene during the last five years; this approach recreates the natural     processes of new blood vessel formation that is observed during growth and development in     every human being. It is an extremely potent and promising modality, but so far the results     of clinical trials in patients have been equivocal.      One reason for the limited efficacy observed thus far with therapeutic angiogenesis may rest     in that factors produced by the lining of the coronary arteries themselves are essential for     angiogenic substances to take effect in the heart muscle of patients with severe coronary     artery disease. These same patients, however, virtually all have, as a result of their     disease, marked dysfunction of their coronaries and therefore fail to produce these factors     in adequate quantities. This hypothesis has been verified with extensive animal data by the     investigators of this research, where a swine model of coronary disease was shown to severely     inhibit the action of angiogenic growth factors. If one wants angiogenesis to work, a means     of improving the function of the coronary lining of patients with severe ischemic heart     disease must be identified and its effects evaluated in order to allow for angiogenic     substances to exert their action towards successful revascularization of the heart muscle.      An amino acid called L-arginine has repeatedly been shown to markedly improve function of the     coronary artery lining in patients with ischemic heart disease when administered regularly     over a period of several months. This research will therefore test, in the form of a     randomized clinical trial, whether this concomitant approach can make angiogenesis effective     in patients with advanced coronary disease, by allowing for the action of growth factors to     take place in the heart. If this approach is successful, as is anticipated, angiogenesis will     constitute an effective modality for the treatment of coronary artery disease, not only in     patients with advanced, severe involvement unamenable to any other form of cardiac therapy     such as coronary artery bypass grafting, but even perhaps in all patients with coronary     artery disease in need of revascularization. The goal of this investigation towards the     making of a new, revolutionary, safe and efficacious modality for the treatment of the number     one killer disease of Canadians is in complete agreement with the primary objective of the     Heart and Stroke Foundation of Canada.   "
175156|NCT00134446|"     The purpose of this study is to determine if transcranial magnetic stimulation at 1 HZ to the     right frontal cortex will decrease the symptoms of post-traumatic stress disorder (PTSD).   "
175157|NCT00134459|"     The purpose of the study is to investigate whether eight weeks of treatment with flexible     doses of bifeprunox is superior to treatment with placebo in depressed patients with bipolar     disorder.   "
175158|NCT00134472|"     The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma     patients, improves neurological outcome.   "
175159|NCT00134485|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin     alone in patients with heterozygous familial hypercholesterolemia   "
175160|NCT00134498|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in     subjects with Fredrickson Type IV Hypertriglyceridemia.   "
175162|NCT00134524|"     This study is intended to demonstrate that exposure to a high intensity, DC electromagnetic     field, as supplied by the investigational device known as the Molecular Magnetic Energizer     (MME), will create a clinically meaningful improvement in pain and nerve dysfunction in the     feet of patients with diabetic peripheral neuropathy (DPN).   "
175163|NCT00134537|"     The purpose of this study is to compare improvement in low back pain with Wallis     (interspinous process implant) to exercise and injections.   "
175164|NCT00134550|"     Lower limb complications are a substantial matter in the diabetic population and studies show     that the annual incidence of foot ulcers ranges from 1.0-4.1% while the cumulative lifetime     incidence is approximately 15%. Foot ulcers may become complicated by infection or gangrene,     and ultimately result in amputation. In addition, foot ulcers have a significant impact on     quality of life (QoL). The treatment of diabetic foot ulcers has not made substantial     progress in recent years with regards to improved healing although there have been several     actions taken to update the process. The current practice consists of wound debridement,     treatment of underlying infections and pressure relief. This trial investigates the     adjunctive effects of high (80 mg) or low (10 mg) dose atorvastatin to conventional treatment     on the healing of diabetic foot ulcers.   "
175165|NCT00134563|"     The primary objective was to determine the effect of teriflunomide on the frequency of     relapses in patients with relapsing multiple sclerosis (MS).      Secondary objectives were:        -  to evaluate the effect of teriflunomide on the accumulation of disability as measured by          Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic          Resonance Imaging [MRI] and patient-reported fatigue;        -  to evaluate the safety and tolerability of teriflunomide.   "
175166|NCT00134576|"     The purpose of this study is to design, refine, and test for the effectiveness of a     computer-based telephone system (Telephone-Linked Communications for Detection of Mental     Health Disorders in the Workplace; TLC-Detect) that will screen workers for mental health     distress; educate them about seeking treatment; and follow up with them over a 6 month     period.   "
175167|NCT00134589|"     The purpose of this study is to determine the effectiveness of a two-component intervention,     that combines academic detailing at the medical practice level and distribution of decision     aids at the patient level, on adherence to colorectal cancer screening guidelines.   "
175250|NCT00128336|"     The purpose of this trial is to determine the most cost effective programme for overweight     and obese individuals to maintain weight loss over a 2 year period.   "
175168|NCT00134602|"     The purpose of the study is to develop and evaluate an intervention to promote adherence to     HIV medications among children 5-12 years of age. It compares changes in antiretroviral (ARV)     adherence between the EIG (enhanced intervention group) and an MIG (minimal intervention     group) from baseline to 4 months post-intervention.      Secondary outcomes include examining whether improvement in adherence to a medication regimen     is associated with improved health outcomes (i.e., viral load, CD4 counts, etc.); identifying     and evaluating predictors and/or mediators of adherence; studying the feasibility of     electronic recording in measuring adherence in an HIV-infected pediatric population; and     evaluating the relationship between the amount of intervention received (i.e., number of     hours/number of sessions) and changes in adherence.   "
175169|NCT00134615|"     The purpose of this pilot project is to test the effectiveness of three 20 minute health     education modules on patient empowerment, patient activation and retention in care.   "
175170|NCT00134628|"     The principle objective of this research is to more precisely determine the degree of benefit     that hyperbaric oxygen therapy affords in the treatment of late radiation tissue injury.      The study has eight* components. Seven involve the evaluation of established radionecrosis at     varying anatomic sites (mandible, larynx, skin, bladder, rectum, colon, and gyn). The eighth     will investigate the potential of hyperbaric oxygen (HBO) therapy to prophylax against late     radiation tissue injury.      *(One of the arms, HORTIS IV - Proctitis has been closed to further patient recruitment. This     decision was based on an interim statistical analysis which generated sufficient evidence to     support closing down this arm of HORTIS.)   "
175171|NCT00134641|"     The purpose of this study is to determine if the combination of gemcitabine and vinorelbine     is effective in treating patients with advanced soft tissue sarcoma.   "
175172|NCT00134654|"     The purpose of this study is to see if Premarin is useful against androgen-independent     prostate cancer and to help understand how drugs such as Premarin may work.   "
175173|NCT00134667|"     The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination     with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of     fluid within the eye and thereby stabilizing or improving vision when compared to Macugen     alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be     eligible for PDT.   "
175174|NCT00134680|"     The purpose of the study is to investigate the effects (good and bad) that the combination of     the drugs letrozole (also called Femara™) and trastuzumab (also called Herceptin®) has on     breast cancer. The United States (US) Food and Drug Administration has approved both     letrozole and Herceptin for the treatment of advanced breast cancer. Doctors hope that the     combination will work better than either drug alone.   "
175175|NCT00134693|"     This study is designed to compare a range of doses of SB-681323 with prednisolone, which has     known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects     on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on     the most effective dose of SB-681323 to use in future.   "
175176|NCT00134706|"     The purpose of this study is to look at the effects (good and bad) of the combination of     docetaxel and carboplatin for patients who have progressive prostate cancer after     chemotherapy with drugs such as docetaxel. The investigators are also studying whether the     measurement of two proteins in the blood may predict who will respond to the combination of     docetaxel and carboplatin.   "
175177|NCT00134719|"     This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to     control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4,     6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and     rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed     with administration of the booster dose. The Protocol Posting has been updated in order to     comply with the FDA Amendment Act, September 2007.   "
175196|NCT00127621|"     This is a phase III trial comparing early tracheotomy versus prolonged endotracheal     intubation in intensive care unit patients needing prolonged ventilatory support.   "
175178|NCT00134732|"     Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the     hospitalization of infants and young children in developed and developing countries and can     be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000     annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against     human rotavirus gastroenteritis. This study will provide data for Korean regulatory     authorities about the immunogenicity and safety of this vaccine in Korean children aged 2     months at the time of the first dose.   "
175179|NCT00134745|"     The purpose of this study is to examine whether a larger dosage of estrogen than the one used     today will secure the development of a normal sized uterus and increase the strength of the     bones in girls and young women with Turner syndrome.      The purpose is also to evaluate whether aortic dilatation is present in this group of     patients, and if the estrogen dosage will influence the emotional well-being and self-esteem     of the patients.   "
175180|NCT00134758|"     Malignant transformation of adenomas of the duodenum is now the leading cause of death in     familial adenomatous polyposis (FAP) patients who had a restorative proctocolectomy.     Ursodeoxycholic acid (UDCA) modifies the biliary acid profile and could reduce the severity     of duodenal adenomas and prevent such transformation.   "
175181|NCT00134771|"     The purpose of this study was to determine whether giving a nutrient enriched formula to     infants born small-for-gestational age benefits blood pressure, growth and body composition     by six months of age.   "
175182|NCT00134784|"     The purpose of this project is to assess the change in dopamine transporter density in     Parkinson's disease subjects during a sixty month period including a nine month treatment     trial of levodopa. Dopamine transporter will be assessed using [123I]ß-CIT SPECT (single     photon emission computed tomography) imaging, a marker of dopamine terminal integrity and of     clinical disease state.   "
175183|NCT00134797|"     The addition of an estimate value of glomerular filtration rate (GFR) per Modification of     Diet in Renal Disease [MDRD] (LEVEY) equation is being included and reported on all routine     chemistry panels in the experimental group. The control group is only having serum     creatinine, the current standard of care, reported on routine chemistry panels.   "
175607|NCT00140959|"     A study to evaluate the effects of combination losartan versus combination atenolol in     patients with ambulatory systolic hypertension.   "
175184|NCT00127465|"     Objective: To explore the hypothesis that different methods of selecting and printing     information for cancer patients could improve emotional support by affecting interaction with     others, and so lead to improved psychological wellbeing.      Design: Randomised trial with 8 groups (three factors, 2X2X2). Data collected at recruitment     and three month follow-up.      Participants: 400 patients starting radiotherapy and their 'confidant' (the person in who     they confide).      Interventions: Printed booklets.        1. Half had 'general' CancerBACUP information for that cancer; half had 'personal'          information from the medical record plus selected general information;        2. Half chose information by 'interacting' with the computer; half had a larger volume of          material in booklets that were produced 'automatically'.        3. Half had additional 'anxiety management advice'.      Outcomes: Patients' views; use of booklet with others; change in reported social support;     change in anxiety and depression.   "
175185|NCT00127478|"     The primary purpose of the study is to evaluate long-term safety and tolerability of     atrasentan 10 mg in men with hormone refractory prostate cancer.   "
175186|NCT00127491|"     The purpose of this study is to see whether esophageal pressure (PES) measurements will allow     the investigators to choose the best method of mechanical ventilation in patients with acute     lung injury (ALI).   "
175187|NCT00127504|"     The purpose of this study is to determine whether rifampin and/or azithromycin are effective     in the treatment of river blindness (onchocerciasis).   "
175188|NCT00127517|"     The purpose of this study is to determine whether patients with advanced cancers who receive     AVR118 solution for injection into the skin can achieve improvement in quality of life. Based     on a study in patients with AIDS, possible benefits may include improved appetite and     strength; weight gain; improved mood; and decreased fatigue. For the first three weeks, some     patients receive AVR118, and others receive placebo (an injection expected to have no     benefits). After three weeks, all patients will be offered the opportunity to take injections     of AVR118.   "
175189|NCT00127530|"     To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in     patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled,     parallel group study.   "
175190|NCT00127543|"     This study is being done to see if education about medicines directed toward children will     improve their knowledge. The investigators also want to know if this knowledge lasts over     time. Right now there are few medication instructional cards that are appropriate for     children. Most of the medication cards provide information for adults. Some studies have     shown that by teaching children directly, the children may take medicine at the right time     for the right reason, have fewer side effects and know more about their medicine.      The purpose of this research study is to see if education about medication helps children     learn more about their medicine and if this knowledge lasts.   "
175191|NCT00127556|"     This study concerns the safety of blood transfusion. Prior to transfusion, staff should     perform a number of essential safety checks to ensure that the correct patient is receiving     the correct blood product. Evidence suggests that these safety checks are not always done.     This study has been designed to assess the effect of a simple intervention on the performance     of the bedside safety check.      The hypothesis is that a simple intervention will improve the performance of the bedside     check.   "
175192|NCT00127569|"     This trial is aimed to study the efficacy of 4 weekly cycles of rituximab in HIV-infected     patients with multicentric Castleman disease (giant lymph node hyperplasia) dependent on     chemotherapy. Efficacy is assessed by the complete response rate at day 60. The patients are     followed until day 365.   "
175193|NCT00127582|"     This is a prospective multicentric Italian study to evaluate the arrhythmic risk in myotonic     dystrophy type 1.   "
175194|NCT00127595|"     This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine     (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of     the urothelial tract.   "
175195|NCT00127608|"     This study is conducted in order to collect clinical samples from patients who are diagnosed     of having chickenpox infection. The results of this study will provide basic scientific     information about chickenpox disease.   "
175197|NCT00127634|"     This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the     Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking     patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month     follow-up period.   "
175198|NCT00127647|"     The purpose of this trial is to evaluate the efficacy and safety of an investigational drug     in adult patients with allergic rhinitis.   "
175200|NCT00127673|"     This study will compare the short- and long-term effectiveness of two different treatments     for people with post-traumatic stress disorder.   "
175201|NCT00127686|"     Cough is the most common reason for an acute care doctor's visit in the United States. Cough     can affect sleep for both coughing children and their parents. The American Academy of     Pediatrics does not endorse the use of dextromethorphan (DM), the most common     over-the-counter (OTC) cough medication because of a lack of efficacy data and some potential     for toxicity, particularly when taken in excess. In fact, DM has previously been shown to be     no better than a placebo for cough in children. Therefore, alternative, therapeutic agents     are needed. Honey anecdotally provides relief for symptoms due to upper respiratory tract     infection (URI). This study seeks to use a survey to evaluate whether a single dose of honey     and/or DM is better than no treatment at all for controlling nocturnal cough in children with     URI and the effect of the treatments on sleep quality for coughing children and their     parents. A single dose of honey or DM will be superior to no treatment for control of     nocturnal cough due to upper URI as rated by both parents and children and will improve the     sleep quality for those children and parents. Compared to DM, honey will be superior for     controlling nocturnal cough due to upper URI (also based on child and parental report).   "
175202|NCT00127699|"     In the United States (U.S.) there currently is no standard method of umbilical cord care,     resulting in varying practices within and across institutions. These differences may result     in an increase in morbidities for newborns such as the formation of umbilical granulomas and     increases in acute care utilization. This study will determine which of two common methods of     caring for newborn umbilical cords is superior - triple dye, followed by the application of     rubbing alcohol, or triple dye alone.   "
175204|NCT00127725|"     Fractures of the tibial shaft (diaphysis) are some of the most common long bone fractures.     They most frequently occur in males less than 40 years of age. Despite advancements in the     surgical management of these fractures, the precarious blood supply and lack of soft-tissue     cover of the shaft of the tibia make these fractures vulnerable to non-union and infection.     These complications often require multiple procedures, extended time off of work, and can     result in ongoing poor mobility. This is reflected in the surgical revision rate that the     scientific literature has recorded as being between 20 and 30%.      Pulsed electromagnetic field (PEMF) stimulation has been shown to be a safe and effective     treatment for non-unions of the tibia. These are fractures in which the bone has failed to     unite and the healing process has ceased. The PEMF is delivered via a device such as the EBI     Bone Healing System®, which straps onto the limb overlying the fracture. It is lightweight     and portable using a rechargeable battery for power. It is compatible with internal and     external fixation and may also be worn over a plaster or fibreglass cast. It is usually kept     in place for ten hours per day and used for a period of three months or until the fracture     unites. In animal models, PEMF stimulation has been demonstrated to improve the time to     fracture healing in acute fractures. There have been no demonstrated side effects of the     therapy.      The study hypothesis is that PEMF stimulation during the first twelve weeks after fracture,     in addition to normal surgical care, will increase the union rate for these fractures and     thereby significantly reduce the surgical revision rate within the first twelve months     following fracture.   "
175205|NCT00127738|"     The RAVE study will compare renal revascularization to medical management for people with     atherosclerotic renal vascular disease (ARVD) and the indication for revascularization.   "
175206|NCT00127751|"     The primary objective of this study was to evaluate the effectiveness of a multifactor     cardiovascular disease (CVD) risk reduction program using team case management in high risk     patients who have low family incomes and limited access to medical care. Patients were     randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month     evaluations of CVD risk factors, clinical status and quality of life.   "
175207|NCT00127764|"     By this study, the investigators want to test if the value of adjuvant pulse glucocorticoid     therapy for pemphigus can be determined by comparing an experimental arm (dexamethasone pulse     therapy, prednisolone, and azathioprine) with a control arm (placebo pulse therapy,     prednisolone, and azathioprine). The investigators will determine the rate of complete     remission with dexamethasone pulse therapy; the time needed for complete remission; and the     duration of remission, and compare these data with those of the placebo arm.   "
175208|NCT00127777|"     This was a randomized, multi-center, partially placebo-controlled Phase IV study to compare     the efficacy and tolerability of a 48-week combined therapy with pegylated interferon     alpha-2a, ribavirin and amantadine sulphate versus placebo in untreated patients with chronic     hepatitis C virus-genotype-1-infection. The hypothesis was that there will be an increase in     sustained response rate for triple therapy compared to current standard treatment.   "
175230|NCT00128076|"     This study will compare two different surgical techniques for repairing a tear in the muscles     of the shoulder (rotator cuff). The investigators will determine whether an arthroscopic or     mini-open technique provides better quality of life and repair integrity.   "
175231|NCT00128089|"     This is a preliminary trial of a new dietary approach to the treatment of obesity related     type 2 diabetes.      Study terminated December 19, 2005 for administrative reasons.   "
175209|NCT00127790|"     Several studies have shown that behavioral therapy for chronic pain can be beneficial for     chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia.     However, seldom do chronic pain patients with insomnia receive a behavioral treatment for     insomnia. The purpose of this study is to evaluate whether treatment for insomnia is helpful     for pain and whether treatment for pain is helpful for insomnia. It will also assess whether     a combined treatment is any more or less effective for pain or for sleep. Finally, the study     will assess whether any of these treatments leads to improvements in immune function.   "
175210|NCT00127803|"     The purpose of this study is to determine the safety and tolerability of a modified C.     difficile vaccine at 3 dose levels compared with a placebo control administered via     intramuscular injection in healthy adults aged 18-55 years of age.   "
175211|NCT00127816|"     Permanent prostate implants are a type of radiation therapy in which a high dose of radiation     is delivered to cancerous tissue by many small radioactive seeds. Studies of early-stage     prostate cancer patients treated in this way and followed for 10 - 12 years indicate a cure     rate of about 80%. This result is similar to surgery and other forms of radiotherapy, but     comes with fewer side effects and greater convenience for the patient. Further studies show     that the radiation dose delivered is the most important factor in achieving a cure. At     present this dose is estimated by a computer, using a computed tomography (CT) scan of the     patient and a simple calculation method. The dose estimate is not as accurate as it could be,     however, because the precise extent of the prostate is hard to determine from the CT scan,     and the calculation method does not make use of information about patient body tissues. The     researchers propose to eliminate these inaccuracies by using magnetic resonance imaging (MRI)     to identify the prostate gland and by developing an improved dose calculation algorithm that     includes information about patient tissues. This new approach will allow physicians to assess     implant quality with greater certainty, improve their implant technique, and ultimately     increase the cure rate to as much as 95%.   "
175212|NCT00127829|"     This study will determine the safety profile and maximum tolerated dose (MTD) of orally     administered gefitinib on a weekly and twice weekly schedule.   "
175213|NCT00127842|"     The overall objective of the study was to describe the long-term effectiveness and safety of     etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.   "
175214|NCT00127855|"     This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine     compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine     and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody     persistence and immune responses to polysaccharide vaccine boosters were additionally     assessed at 11 to 14 months of age.   "
175608|NCT00140972|"     A Study to Assess Etoricoxib versus Diclofenac in Chinese Patients with Osteoarthritis of the     Knee or Hip   "
175215|NCT00127868|"     Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate     tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide     shampoo has been the gold standard, its strong odor and its drying effect on the scalp     discourage many patients from using it. Meanwhile, no other antifungal shampoo has been     rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin     accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known     which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to     cure, nor which do so the fastest.      Scalp ringworm can also re-occur in the same child. To date, no studies have been done to     find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp     ringworm.      In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis,     will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly     assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or     baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All     patients will continue using the same assigned shampoo twice weekly for 24 weeks, while     continuing to return to clinic every 4 weeks for scalp evaluation.   "
175216|NCT00127881|"     The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients     with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to     treatment with Targretin® and one other standard therapy.   "
175217|NCT00127907|"     Recent studies have suggested that arginine-vasopressin could be more effective in the     treatment of cardiac arrests. The last published study did not outline obvious improvements     in the prognosis of all cardiac arrests but pointed out a possible increased survival rate     when arginine-vasopressin is associated with epinephrine. The aim of this study is to compare     the efficacy of two successive injections of epinephrine (1 mg) with two successive     injections of epinephrine associated with arginine-vasopressin (40 UI) in out-of-hospital     cardiac arrests occurring in adult patients. The primary endpoint is the survival rate at     hospital admission. The inclusion period lasts 18 months and 2416 patients are planned to be     enrolled.   "
175218|NCT00127920|"     The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian     tube epithelial cancer, and peritoneal cancer is with maximal upfront therapy (Morrow &     Curtin, 1998). This involves an optimal primary tumor debulking surgery. The most active     chemotherapy agents should then be promptly administered. Taxol and Carboplatin or Cisplatin     have become the standard first line therapy because of proven survival benefits with those     regimens in treating advanced ovarian adenocarcinoma patients. New chemotherapy agents like     bevacizumab have demonstrated increased overall and progression free survival benefits in     metastatic colorectal cancer patients and are being studied for their potential contributory     impact on the current standard of treatment. Since no triplet regimen has demonstrated     compelling superiority, the combination of taxol, carboplatin, and bevacizumab is intriguing     because of their potential synergy, distinct mechanisms of action, and non-overlapping     toxicity.      The null hypothesis (Ho) is that the drug regimen will demonstrate an 80% patient response     rate (RR).      The alternative Hypothesis (H1): The triplet drug regimen will demonstrate a significantly     higher patient response rate than standard therapy.      Hypothesis (H2): The triplet drug regimen will demonstrate a significantly more favorable     patient time to tumor progression rate than standard therapy.   "
175232|NCT00128102|"     This is a study to determine the safety, tolerability, and anti-tumor effectiveness of an     oral investigational drug, suberoylanilide hydroxamic acid, in the treatment of advanced     malignant pleural mesothelioma.   "
175219|NCT00127933|"     This single arm study stratified patients into two treatment cohorts based on HER2-neu     overexpression/amplification. Each cohort will be independently powered for the primary     endpoint. The study will evaluate the efficacy, safety and impact on quality of life of     treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu     negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv)     Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same     chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will     receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration [po] twice     daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will     also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
175220|NCT00127946|"     Hypothesis: Gastroschisis is a localised disruption of the abdominal layer. It occurs early     in gestation, and the bowel is therefore bathing in the amniotic fluid and can be constricted     at the level of the abdominal hole. The bowel is therefore submitted to different injuries     partly attributable to the contact with amniotic fluid contaminated by digestive compounds     and inducing an inflammatory reaction. Experimental studies on animal models and preliminary     data in humans indicate that changing regularly the amniotic fluid (i.e. AMNIOECHANGE) would     improve the outcome of theses fetuses and then neonates.   "
175221|NCT00127959|"     This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in     antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).      Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A     is being conducted. (Substudy A1)   "
175222|NCT00127972|"     It is desirable to obtain extended follow up data on subjects who participated in the 2NN     study and the CHARM study in order to see if the beneficial effect of using nevirapine     continues up to 144 weeks of treatment.   "
175223|NCT00127985|"     Background: Systemic corticosteroids are considered in patients with an adverse clinical     course suffering from conditions like the acute respiratory distress syndrome (ARDS) and     septic shock. Treated patients not only show improved respiratory function, but also     hemodynamic status and overall multiple organ dysfunction score.      Objective: To evaluate the safety and effectiveness of 6-methyl-prednisolone on the clinical     course of multiple organ dysfunction syndrome (MODS).      Design: Multi-center, double-blind, randomized, placebo-controlled.      Intervention: Intravenous administration of 6-methyl-prednisolone or placebo (aqueous     solution). The duration of the study medication administration protocol is 32 days (1).      Primary Endpoints:        1. All cause Intensive Care Unit (ICU) and 28-day mortality        2. Organ dysfunction score on days 4, 7, 14, and 28 of the protocol.   "
175224|NCT00127998|"     Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the     continuing development of resistance to new antimalarial formulations is one of the major     obstacles to effective malaria control and case management. Efficient, comprehensive and     validated methods for monitoring drug resistance in advance of the development of resistance     to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic     polymorphisms that give rise to resistant P. falciparum parasites and methods in population     genetics for evaluating the data can be valuable tools for monitoring drug resistance in the     field. This study aims to:        1. Prospectively measure the in vivo response of P. falciparum malaria in Mali to several          different antimalarial drugs and drug combinations: chloroquine (CQ),          sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in          combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate          (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and          artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high          rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested.        2. Measure the frequencies of molecular markers for antimalarial drug resistance, and          examine how those results relate to the efficacy of these drugs in treating clinical          malaria        3. Measure drug levels at 3 days and correlate with efficacy results.        4. Examine early clinical, parasitologic, and clinical predictors of late treatment          failure.        5. Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide          resistance surveillance system for antimalarial drugs.   "
175225|NCT00128011|"     The purpose of this study is to evaluate the safety and immunogenicity of a new formulation     of a locally-produced bivalent, (O-1 and O-139) killed whole cell oral cholera vaccine among     Vietnamese adults.   "
175226|NCT00128024|"     Statins have been shown to prevent coronary artery disease and to preserve left ventricular     function in dilated cardiomyopathy. The investigators hypothesized that the early use of     statins would reduce cardiovascular events including heart failure in acute myocardial     infarction patients. The purpose of this study is to determine whether early (within 96 hours     after onset) use of any available statins are effective to prevent cardiovascular events     including heart failure after acute myocardial infarction in Japanese patients.   "
175227|NCT00128037|"     The purpose of this study is to evaluate the safety and efficacy of the trimodality     (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus     tumors.   "
175228|NCT00128050|"     Although the role of surgical treatment is still controversial, surgical evacuation of     intracerebral hematoma is a frequent practice. Rebleeding is a frequent complication in     patients submitted to hematoma evacuation. It has been reported that smaller postoperative     volume of hematoma is associated with a better outcome. The investigators hypothesize that     the administration of Factor VIIa (Eptacog alfa) immediately after surgical evacuation of the     hematoma can reduce postoperative rebleeding.      Aims of the Study:      This study will investigate:        1. The efficacy of Eptacog alfa in preventing or reducing rebleeding after surgery for          spontaneous supratentorial ICH; and        2. The safety of product administration   "
175229|NCT00128063|"     The primary objective of the study is to evaluate the pharmacokinetic behavior of Suc-HSA     after consecutive daily intravenous (i.v.) doses. The secondary objectives are to evaluate     the safety and tolerability and the antiretroviral and immunological effects of consecutive     daily i.v. doses of Suc-HSA.   "
175627|NCT00141219|"     To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose     adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with     peripheral neuropathic pain.   "
175233|NCT00128115|"     The purpose of this study is to demonstrate an improvement in physical functional recovery,     following administration of Drug for 24 weeks, in patients who have recently experienced a     hip fracture. This study will also evaluate the safety and tolerability of Drug.      This is an early phase trial and some specific protocol information is proprietary and not     publicly available at this time. (Full information is available to trial participants).   "
175234|NCT00128128|"     This study will determine whether cranberry juice is effective in reducing recurrent urinary     tract infections (UTIs) in women who have had a UTI within the past year.   "
175235|NCT00128141|"     Two groups of preterm infants with birth weight equal to or less than 1500 grams will be     studied. One group will receive the standard care and the other will receive standard care     plus maternal special tactile stimulation. Gain of weight, length and head circumference,     date of the beginning of enteral feedings, length of time to recover birth weight and age of     hospital discharge will be recorded and compared between both groups.   "
175236|NCT00128154|"     The purpose of this study is to determine whether chromium supplements can reduce symptoms of     metabolic syndrome, a collection of symptoms that increase one's risk for developing heart     disease, stroke, and diabetes.   "
175237|NCT00128167|"     The primary objective of this study is to estimate the relative efficacy and assess the     safety of CAIV-T compared to TIV.   "
175238|NCT00128180|"     The purpose of this study is to see if a drug, called methylprednisolone, is safe and     effective in people with Hantavirus infection. Individuals 2 years of age or older are     invited to participate in this study if their doctor suspects or knows they have Hantavirus     infection. Volunteers will either be given methylprednisolone or placebo (contains no     medication) through a needle inserted in a vein for 3 days. During the first 7 days of     hospitalization procedures may include blood tests, physical exams, chest x-rays, and urine     tests. During study visits on days 14, 28, 84 and 180 after diagnosis, the doctors will ask     about health, examine the body, take a chest X-ray, collect blood for safety testing and for     measuring antibodies, and do breathing tests on volunteers. Participants will be involved in     the study for about 6 months.   "
175333|NCT00137215|"     The purpose of this study is to compare one type of dressing against the current standard     dressing that is used to cover an unburned area of the skin where a piece of skin is removed     to cover another part of the body that was burned.      Hypothesis: The mean healing time for wounds treated with the Silverlon Dressing will be less     than the mean healing time for wounds treated with Xeroform Dressing.   "
175609|NCT00140985|"     Antiproteinuric Efficacy of Losartan Potassium in Patients with Non-Diabetic Proteinuric     Renal Diseases.   "
175239|NCT00128193|"     The purpose of this study is to see how healthy people and leprosy patients react to 2 new     skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in     measuring the number of people exposed to leprosy and enable its diagnosis and treatment at     an earlier stage. Participant's ages 18-60 living in Kathmandu, Nepal will be enrolled.     Stages A and B of the study will use the skin test in healthy volunteers. Stage C will use     the skin test in high risk volunteers (including individuals with leprosy), healthy     individuals in contact with leprosy patients and individuals with tuberculosis (TB, lung     disease). Study procedures will include injections, physical exam, and blood testing.     Injection sites will be checked several times during the participant's study involvement (5     hours of time spread over approximately 1 month). Volunteers screened for the study, which     have leprosy or tuberculosis will be treated or referred for treatment.   "
175240|NCT00128206|"     The purpose of this study is to determine whether an alternative drug, (rifampin) given     daily, is better at treating tuberculosis (TB) and more tolerable than the usual drug     treatment, isoniazid (INH). Study participants will include 972, TB infected, San Francisco     Jail inmates, aged 18 or older. One group of volunteers will take INH two times a week for 9     months, and the other group will take rifampin daily for 4 months. Medication will be     administered in jail and at the San Francisco TB Clinic if the volunteer is released from     jail prior to completing the study. Participants will be seen daily for 4 months (rifampin     group), and 2 times a week for 9 months (INH group) for directly observed therapy. Study     procedures will include 5 symptom review visits and blood samples for lab testing. Follow-up     will continue for each subject for five years after enrollment into the study.   "
175241|NCT00128219|"     The group B streptococcus (GBS) vaccine study is being done to see if a single vaccination     with a GBS type III vaccine can stop women from getting GBS type III bacteria in the vagina.     Approximately 600 women, ages 18-40, will be enrolled from the clinical sites participating     in this study. Participants will be non-pregnant, sexually active (sex with a male at least     once in the last 4 months), and GBS negative in the vagina or rectum at the screening visit.     Participants will be randomly assigned to receive the experimental GBS type III vaccine or a     licensed vaccine containing Tetanus and Diphtheria Toxoids (Td). Participants will be     followed at one month, 2 months and every other month thereafter following vaccination (for     vaginal and rectal swab collection and a blood draw) for 1½ years or a total of 10 post     vaccination visits.   "
175242|NCT00128232|"     Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma     causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is     approved for treatment of acromegaly after surgery if the disease is not controlled. This     study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who     did not have any previous treatment for acromegaly.   "
175243|NCT00128245|"     This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%)     ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS,     dry eye syndrome) patients.   "
175244|NCT00128258|"     This research study is being performed to find out more information about the safety and     effectiveness of injecting bone marrow progenitor cells (BMPCs) from one's own hip bone into     one's heart muscle. The BMPCs are the cells from which the different types of blood and other     cells grow.      In patients with heart failure, the heart muscle does not pump well. Over a period of years,     this continues to get worse until the patient dies of heart failure. The investigators are     trying to find out if the injection of these BMPCs can make a change in the functioning of     these areas of the heart muscle. Data from studies around the world have suggested that when     patients with heart failure receive these cells by direct injection into their hearts they     show signs of recovered heart function, however, there has been no evidence from actual     studies of the cells of the patient's hearts to show how this process works. It is the     investigator's plan to inject an eligible participant's heart with cells that are from one's     own bone marrow during an operation to receive a ventricular assist device (VAD) or partial     artificial heart and then to study the function of the heart while awaiting a heart     transplant. The investigators will then examine the heart after it has been removed as part     of the regular heart transplant operation for any microscopic changes (changes too small to     be seen by the unaided eye but large enough to be studied under a microscope) at the site     where the cells are injected. Participants will have no change in the chances of receiving a     heart transplant by agreeing to participate in this study. There will also be no delay in     receiving a VAD operation while waiting to participate in this study. This Phase I study has     been cleared by the Food and Drug Administration (FDA) to enroll and treat patients. The     Center for Biologics Evaluation and Research Investigational New Drug number (IND BB #) is     12304. (A Phase I trial is a research study using techniques or products in the first-stage     or for the first time in human subjects).   "
175245|NCT00128271|"     The purpose of this study is to determine the safety and tolerability of bavituximab when     administered via a vein as a single infusion and to examine how bavituximab behaves in the     body and how it affects the amount of hepatitis C virus in individuals with chronic     infection.   "
175246|NCT00128284|"     The purpose of this study is to determine the correlation between gastric residence time of     the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled     meal as measured by gastric emptying scintigraphy.   "
175247|NCT00128297|"     The study objective is to evaluate the differences, in terms of first occurrence of a     skeletal event, in patients with breast cancer and symptomatic bone metastases, when     pamidronate is administered during 2 years, or when it is administered during 6 months,     followed by a six month rest period, and again a 6 month treatment period.   "
175248|NCT00128310|"     The investigators assume that progression-free survival mean time for patients treated with     vinorelbine will be 3 months, and for patients treated with gemcitabine plus vinorelbine will     be 5 months. That implies a reduction in risk ratio of 40% (Hazard ratio = 1,67). Assuming a     bilateral alpha error of 0.05 and beta error of 10%, and the number of events needed if 60%     of patients have progressed after 1 year, the number of patients needed per treatment arm is     114. Considering a 10% post-randomization drop-out, the final number of patients is 252 (126     per arm).   "
175249|NCT00128323|"     In resource constrained societies and where HIV is a problem, oral thrush causes significant     morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are     relatively expensive compared to GV solution and ketoconazole has significant side effects     especially in association with some of the treatments for HIV related problems.      In children, either GV solutions or nystatin are used, GV is a fraction of the cost of     nystatin.      GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark     them out as having HIV infections. A much more dilute solution of GV has proved equally     effective in vitro and would not carry the same cosmetic problem.      In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165%     GV and nystatin oral drops - all masked so that they look the same - to see if GV is more     effective than nystatin, and to see if the weaker solution of GV is as effective as the     stronger solution.   "
175251|NCT00128362|"     The advent of mammography and increased awareness of breast cancer has resulted in detection     of smaller tumors, the majority of which would not have had metastasized to the axillary     lymph nodes. The sentinel node (SN) is presumably the first echelon node in the axillary     basin to become involved with metastatic breast cancer cells. Sentinel node biopsy (SNB) in     operable breast cancer has gained popularity since it promises to avoid treatment of the     axilla when the nodes are negative for metastasis. Advances in technology (radio-guided SNB)     is associated with a risk of false negative SN reporting in 4-12%. The consequence of leaving     behind untreated positive non-sentinel nodes in the axilla is a potential risk for axillary     recurrence. Axillary sampling is a simple and inexpensive procedure in which level I nodes     are removed by a blind dissection. The investigators critically analyzed the efficacy of both     the procedures separately in consecutive pilot studies i.e., targeted SNB versus blind     axillary sampling. The current study is planned as a prospective comparison study where a     patient undergoes both the procedures in the same surgical intervention and thus provides an     immediate comparison of the two techniques with respect to their effectiveness.   "
175252|NCT00128375|"     The purpose of this study is to test the effectiveness of financial incentives for increasing     long-term smoking cessation rates among employees at General Electric worksites throughout     the United States.   "
175253|NCT00128388|"     This study will determine the effectiveness of a manualized form of brief psychodynamic     psychotherapy in comparison with applied relaxation training in treating adults with panic     disorder.   "
175254|NCT00128401|"     This study examines whether an antibiotic, d-cycloserine (DCS), boosts the effectiveness of     cognitive behavior therapy (CBT) for social anxiety. CBT has been shown to be effective for     the treatment of social anxiety in children and adults, but even after treatment,     approximately 40% may remain diagnosable. The antibiotic DCS has been shown to enhance the     type of learning that is promoted by exposure therapy, a main component of CBT. This study     will test whether DCS can improve the effectiveness of CBT for social anxiety.      All participants will receive 12 weekly CBT sessions. In addition to receiving the CBT,     participants will be randomly assigned (similar to a coin toss) to receive either DCS or a     placebo (sugar pill). The pill will be taken 1-2 hours prior to each of the 12 CBT sessions.     The pill is taken only on the 12 therapy days.      Prior to receiving treatment, participants will be asked to:        -  participate in interviews to assess diagnosis and how they are doing including mood,          degree of nervousness and behavior        -  have a physical examination, a urine test, and an electrocardiogram (EKG)        -  undergo tests involving problem-solving and memory        -  prepare and present a speech to a virtual audience using virtual reality goggles        -  undergo functional magnetic resonance imaging (fMRI) while performing tasks that involve          looking at pictures, remembering things, testing reaction times, and making simple          choices      Those who have not improved by the end of the study will be offered standard antianxiety     medication treatment for 1 to 3 months. If a participant does not wish to take medication,     study clinicians will help him/her locate psychological care in the community. Participants     will be asked to complete a follow-up assessment 3 months after their last CBT session.   "
175255|NCT00128414|"     The purpose of the study is to determine whether colchicine is safe and effective in the     treatment and prevention of recurrent pericarditis (first episode).   "
175256|NCT00128427|"     The purpose of the study is to determine whether colchicine is safe and effective in the     prevention of the postpericardiotomy syndrome.   "
175257|NCT00128440|"     The primary objective of this study was to compare the efficacy and safety of 200 μg and 400     μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat®     Inhaler once daily for four weeks in patients with COPD.   "
175258|NCT00128453|"     The purpose of the study is to determine whether colchicine is safe and effective in the     treatment of acute pericarditis and the prevention of subsequent recurrences.   "
175259|NCT00128466|"     This clinical trial will compare the effectiveness of streptomycin, which historically is the     standard drug for treatment of plague, with gentamicin. The hypothesis is that gentamicin is     not inferior to streptomycin but that it will have less severe side effects. The study is     being done in Madagascar because that country reports the most plague cases in the world.     Patients coming into a participating clinic with suspected plague (bubonic, pneumonic, or     septicemic) will be randomized into one of two treatment arms after giving informed consent.     Patients will be monitored for side effects and for improvement of symptoms.      In addition, rapid diagnostic test strips have been developed but not fully evaluated for use     on humans. The investigators will evaluate these new tests on specimens from the same     patients, comparing their performance with that of classical diagnostic methods such as     culture and serology.   "
175260|NCT00128479|"     Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called     cortisol. Under normal conditions, cortisol and other hormones are created by the body in     response to physical and emotional stress, triggering a healthy stress response. People who     suffer from psychotic major depression may have unusually high levels of cortisol circulating     within them or abnormal patterns of cortisol levels, overloading the stress response     mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If     Corlux can keep the body's cortisol receptors from being overloaded, the stress response     system may return to normal function, which may result in improvement of symptoms. The     purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients     who have been diagnosed with psychotic major depression (PMD).   "
175261|NCT00128492|"     The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI     in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).   "
175334|NCT00137228|"     The purpose of this study is to determine the reliability and concurrent validity of the     figure-of-eight method of measuring hand edema in the burn patient population. Establishing     the reliability and validity would enable a more time efficient assessment than the currently     accepted methods.   "
175420|NCT00138359|"     Investigators from Cayetano Heredia University and Johns Hopkins University are doing this     study. They want to see how people and pigs get infected with a parasite, called cysticercus     (known as pig triquina). Cysticercus attacks the meat of pigs and the brains of people. In     the intestine, the parasite is known as solitaria. This study is to see how treatment in     both people and pigs works to control the disease.   "
175262|NCT00128505|"     Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called     cortisol. Under normal conditions, cortisol and other hormones are created by the body in     response to physical and emotional stress, triggering a healthy stress response. People who     suffer from psychotic major depression may have unusually high levels of cortisol circulating     within them or abnormal patterns of cortisol levels, overloading the stress response     mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If     Corlux can keep the body's cortisol receptors from being overloaded, the stress response     system may return to normal function, which may result in improvement of symptoms. The     purpose of this study is to allow patients who have already participated in an earlier 8 week     study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment     with Corlux periodically if a psychotic episode should reappear during a period of one year.   "
175263|NCT00128518|"     The principal scientific objective of the trial is to identify the factors that are     associated with differential blood pressure responses between drugs. This may allow     investigators to produce new hypotheses on the pathophysiology of hypertension and on the     mechanisms of drug action.      These factors can be of different types:        -  Environmental factors (sodium or alcohol intake);        -  Morphological (height, weight, body mass index, body surface area);        -  Initial blood pressure;        -  Electrocardiogram (ECG) parameters of left ventricular hypertrophy;        -  Biological parameters as the activity level of the renin angiotensin aldosterone system;        -  Genetic polymorphisms.   "
175264|NCT00128531|"     The purpose of this study is to look at the efficacy and safety of leuprolide acetate in     patients with prostate cancer.   "
175265|NCT00128544|"     This study is being conducted to compare the effectiveness of the combination of     valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.   "
175266|NCT00128557|"     The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered     to newborn infants within the first days of life, reduces six-month infant mortality by at     least 15%. The trial will also evaluate whether the survival impact of newborn vitamin A     dosing is modified by concurrent weekly, routine maternal vitamin A or beta-carotene     supplementation during pregnancy through three months postpartum, gestational age and birth     size.   "
175267|NCT00128570|"     RATIONALE: An internet-based health behavior program that provides information about physical     activity, fitness, and nutrition may help participants become healthier and reduce the risk     of developing cancer.      PURPOSE: This randomized clinical trial is studying an individualized internet-based health     behavior program to see how well it works compared to a standard internet-based health     behavior program in preventing cancer and improving physical activity, fitness, and nutrition     in participants who are physically inactive with a higher body mass index.   "
175268|NCT00128583|"     RATIONALE: Vaccines made from tumor cells may help the body build an effective immune     response to kill tumor cells.      PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating     patients with malignant melanoma.   "
175269|NCT00128596|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.      PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients     with metastatic liver cancer that cannot be removed by surgery.   "
175270|NCT00128622|"     RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry     cancer-killing substances directly to the cancer cells. Vaccines made from a gene-modified     virus and a person's white blood cells may help the body build an effective immune response     to kill cancer cells. Giving denileukin diftitox together with vaccine therapy may kill more     cancer cells.      PURPOSE: This phase I trial is studying the side effects of giving denileukin diftitox     together with vaccine therapy in treating patients with metastatic cancer that expresses     carcinoembryonic antigen.   "
175271|NCT00128635|"     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody     TNT-1/B (^131I MOAB TNT-1/B), can find tumor cells and carry tumor-killing substances to them     without harming normal cells. This may be an effective treatment for glioblastoma multiforme.      PURPOSE: This phase I trial is studying the side effects and best dose of ^131I MOAB TNT-1/B     in treating patients with progressive or recurrent glioblastoma multiforme.   "
175669|NCT00141765|"     The purpose of this study is to determine whether very high dosages of chemotherapy will     improve the chance of surviving cancer.   "
175272|NCT00128661|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing,     or coming back. Vaccines may help the body build an effective immune response against human     papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or     cervical cancer. It is not yet known whether human papillomavirus vaccine is more effective     than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer.      PURPOSE: This randomized phase III trial is studying human papillomavirus vaccine to see how     well it works compared to hepatitis A vaccine in preventing cervical intraepithelial     neoplasia or cervical cancer in younger healthy participants.   "
175273|NCT00128687|"     To examine whether the Stanford Health Education and Risk Reduction Training (HEAR2T) program     , a case management approach, can be effectively used to manage the risk of coronary artery     disease.   "
175274|NCT00128700|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Vatalanib may stop the growth     of tumor cells by blocking blood flow to the tumor. Giving temozolomide and radiation therapy     together with vatalanib may kill more tumor cells.      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of     vatalanib when given together with temozolomide and radiation therapy and to see how well     they work in treating patients with newly diagnosed glioblastoma multiforme.   "
175351|NCT00137449|"     To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant     gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule   "
175352|NCT00137462|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed     dyslipidemias   "
175275|NCT00128713|"     The primary objective of this study is to compare the three study arms of lower, medium, and     higher dose platelet therapy with respect to the percentage of patients experiencing at least     one episode of Grade 2 or higher bleeding as determined by the Platelet Dose Trial Bleeding     Scale (Grade 2 bleeding corresponds to bleeding that is moderate, but not severe enough to     warrant red blood cell transfusion).      There are a number of secondary endpoints related to platelet transfusions, hemostasis, and     other concerns. The four most important secondary endpoints will compare the three study arms     with respect to the following outcomes: 1) platelet utilization rates (total number of     platelets transfused x 10 ^11); 2) number of platelet transfusion events (frequency of     transfusions); a transfusion event would be defined as each separate platelet transfusion     issued by the study site's transfusion service; 3) highest category of bleeding during time     of study (Platelet Dose Trial Bleeding Scale Grades less than or equal to 1, 2, 3, or 4 by     arm); and 4) bleeding severity based on number of days with bleeding (total days of bleeding     and bleeding/thrombocytopenic day), intensity of bleeding, and number of sites with bleeding     (if such a severity score has been validated and published by the time the study is     completed).   "
175276|NCT00128726|"     The purpose of this study is to determine the safety and efficacy of a continuous combined     oral contraceptive pill (CCOCP) regimen. The investigators hypothesize that there will be a     decrease in the number of vaginal bleeding days in the continuous regimen compared to a     traditional 21/7 regimen. In addition, the investigators hypothesize that there will be     increased endometrial and ovarian suppression in the CCOCP regimen.   "
175277|NCT00128739|"     Twenty-four (2 x 12) patients with intestinal graft versus host disease (GVHD) Grades 2, 3 or     4 will be treated with budesonide 3mg three times daily or placebo for 12 weeks. All of the     patients will receive cyclosporine and by mouth (po) prednisone or intravenous (IV)     methylprednisone with a starting dose of 2mg/kg/day (standard anti-GVHD treatment). Doses of     steroids will be decreased by approximately 10% or 10mg per week (depending upon patient’s     weight) upon response to therapy, defined as a decrease of volume of diarrhea by 50% per day,     decrease in abdominal pain and no presence of bloody stool. Patients with Grades 3 or 4 will     be withdrawn from the study if there is no response after one week of therapy. Patients with     Grade 2 may continue with no decrease in prednisone dose until response is achieved.   "
175278|NCT00128752|"     A controlled dietary intervention study will be carried out based on the stable isotope     method the investigators have developed to quantify both the absorption of beta-carotene and     its bioconversion to retinol in oil and in a mixed diet. For 6 weeks the participants will     consume 2 capsules/day, 7 days/week with each capsule containing 50-mg [13C10] beta-carotene     and 50-mg [13C10] retinyl palmitate. For three weeks they will consume a diet with high     levels of beta-carotene in vegetables and fruits and for the other 3 weeks they will consume     a diet with low levels of beta-carotene in vegetables and fruits supplemented with an extra     amount of beta-carotene in oil. Samples of blood and faeces will be taken.      The study hypothesis is that the absorption of beta-carotene in oil in comparison with the     absorption of beta-carotene in a mixed diet differs by a factor of 3 to 6. The investigators     want to measure the influence of the food matrix of vegetables and fruits on the absorption     of beta-carotene in healthy humans on a western diet.   "
175279|NCT00128765|"     In this randomized controlled trial, three contemporary modes for chronic obstructive     pulmonary disease (COPD) management in Dutch general practices are compared for costs and     effects:        -  usual general practitioner (GP) care (at patient's initiative);        -  regular practice nurse review; and        -  integrated self-management education.      All three interventions are based on existing guidelines, materials, and field experiences.   "
175280|NCT00128778|"     This is a randomized, prospective and multicenter phase IV clinical trial, which has been     designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be     recruited in the study.   "
175281|NCT00128791|"     In patients admitted with acute myocardial infarction, there is a total occlusion of a     coronary artery. Even after emergency catheterization and angioplasty, in some patients, the     resumed blood flow is suboptimal and impacts on heart function. The study is aimed at     examining whether nitroprusside, an anti-hypertension medication, given directly into the     coronary artery, can improve the blood flow after the removal of the obstruction that caused     the infarction.   "
175324|NCT00135044|"     The purpose of this study is to investigate whether the inclusion of 1g of intravenous     taurine as part of the nitrogen source of parenteral nutrition reduces parenteral nutrition     associated cholestatic liver disease, a common side effect of parenteral nutrition.   "
175325|NCT00135057|"     The purpose of this study is to compare the change in glycemic control, as measured by     hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin     glulisine as mealtime insulin following a variable bolus insulin regimen (based on     carbohydrate counting) versus a fixed bolus insulin regimen, with insulin glargine as basal     insulin in both arms of the study.   "
175282|NCT00128804|"     A controlled dietary intervention study will be carried out based on the stable isotope     method the investigators have developed to quantify both the absorption of beta-carotene and     its bioconversion to retinol in oil and in a mixed diet. For 4 weeks the participants will     consume 2 capsules/day, 7 days/week with each capsule containing 100-mg [13C10] beta-carotene     and 100-mg [13C10] retinyl palmitate. For two weeks they will consume a diet with high levels     of beta-carotene in vegetables and fruits and for the other 2 weeks they will consume a diet     with low levels of beta-carotene in vegetables and fruits supplemented with an extra amount     of beta-carotene in oil. Samples of blood and faeces will be taken. The study hypothesis is     that the absorption of beta-carotene in oil in comparison with the absorption of     beta-carotene in a mixed diet differs by a factor of 3 to 6. The investigators want to     measure the influence of the food matrix of vegetables and fruits on the absorption of     beta-carotene in ileostomy patients on a western diet.   "
175386|NCT00137904|"     Fatigue is a frequent and disabling symptom in patients with multiple sclerosis (MS). The     pathophysiology of this sign is not fully understood. Some data suggest that the fatigue is     associated with sleep disorders. The aim of this study is to determine the polysomnographic     parameters in MS patients with fatigue in comparison to MS patients without fatigue.   "
175734|NCT00142623|"     The purpose of this study is to develop and evaluate the efficacy of five tailored DVDs in     reducing exposure to environmental tobacco smoke (ETS) among low income pregnant/postpartum     women.   "
175283|NCT00128817|"     Surgery with post operative radiotherapy (PORT) had been the mainstay of treatment for     advanced laryngeal-pharyngeal cancers (ALHC) until the eighth decade of the past century.     Total laryngectomy with post-operative radiotherapy (TL + PORT) used to result in permanent     tracheostomy and loss of speech.      Early trials like the VA or European Organisation for Research and Treatment of Cancer     (EORTC) trials compared surgery with post-operative radiotherapy to induction chemotherapy     (ICT) and radiotherapy (RT). Subsequent attempts have been focused on the added benefit of     including concurrent chemotherapy. There is no randomized trial available in the literature     comparing concurrent chemoradiation with the standard treatment, i.e. surgery followed by     radiotherapy. However, most of the studies comparing neoadjuvant chemotherapy and     radiotherapy reported better locoregional control rates and better survival rates with     surgery followed by post-operative chemotherapy. Further, the advances in primary voice     rehabilitation have substantially improved the quality of life after laryngectomy. Thus,     there is a strong case for comparing the results of concurrent chemo-radiation with surgery     and post-operative radiotherapy in a randomized clinical trial. This trial will answer the     question - whether we are saving voice at the cost of life.      The investigators propose to randomize 900 patients of laryngeal and hypopharyngeal cancers     in surgery with PORT and a concomitant chemoradiation arm and compare the survival and     locoregional control rates.   "
175284|NCT00128830|"     The purpose of this study is to evaluate the long-term safety and tolerability of etravirine,     administered as part of an individually optimized antiretroviral therapy (ART), in human     immunodeficiency virus Type 1 (HIV-1) infected participants.   "
175285|NCT00128843|"     This is a pivotal phase II, multicenter, open-label trial, designed to compare the efficacy     of exemestane versus anastrozole as a first line treatment for advanced breast cancer. One     hundred postmenopausal patients, with metastatic, positive hormone receptor breast cancer     will be enrolled in this trial.   "
175286|NCT00128856|"     This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT     neoadjuvant regimen in patients with stage III breast cancer, confirmed by true-cut or open     biopsy.   "
175287|NCT00128869|"     This study aims to compare whether or not there is a difference in the effectiveness of upper     back (thoracic spine) mobilizations versus manipulations used in a population of patients     with mechanical neck pain. The investigators hypothesize that patients receiving a     manipulative technique will experience better outcomes than patients receiving the     mobilization techniques and these results will be evident at a 48-hour follow-up.   "
175288|NCT00128882|"     The purpose of this study is to describe the effect of anti-D on symptoms and platelet count     in children suffering from unexplainable low platelet counts, when anti-D is administered as     an injection under the skin. The hypothesis is that the injection with anti-D under the skin     is as effective as anti-D given in a vein.   "
175289|NCT00128895|"     Treatment of patients with PR3-ANCA-associated vasculitis consists of two phases: remission     induction with highly effective, but also relatively toxic, drugs and, secondly, after     remission is achieved, maintenance therapy with less toxic drugs. Currently,     remission-maintenance therapy with azathioprine is stopped after approximately 18 months.     However, the optimal duration of azathioprine maintenance therapy is unknown.      The investigators have found that patients with PR3-ANCA-associated vasculitis who remain     cytoplasmic anti-neutrophil cytoplasmic autoantibody (C-ANCA) positive after induction of     remission have an increased risk to experience relapse of disease. Therefore they will test     whether relapse risk in these patients can be reduced by extending maintenance therapy at the     cost of acceptable therapy related toxicity. After induction of stable remission, ANCA will     be measured by immunofluorescence (IIF). C-ANCA positive patients will be randomized for     either standard therapy with azathioprine (until 18 months after diagnosis), or longterm     azathioprine maintenance therapy (until 48 months after diagnosis).   "
175290|NCT00128908|"     This is an open label, crossover pilot study to explore the safety and efficacy of a rapid     cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus     harboring genotypic resistance to at least three classes of antiretroviral therapy.   "
175291|NCT00128921|"     Velcade (bortezomib, PS-341) has recently been approved by the Food and Drug Administration     (FDA) for the treatment of multiple myeloma for patients who have received at least one prior     therapy. Velcade is a unique compound developed by scientists at Millennium Pharmaceuticals,     Inc. Velcade enters cells and affects the way they divide. Cancer cells are particularly     sensitive. Velcade interferes with the enzyme proteasome which is responsible for allowing     cells to divide. When cancer cells cannot divide, they die. Velcade falls into the class of     drugs known as proteasome inhibitors.   "
175292|NCT00128934|"     The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE)     is effective in treating the symptoms of severe premenstrual syndrome (PMS).   "
175326|NCT00135070|"     Hyperglycaemia has been shown to increase morbidity and mortality in patients with critical     illness, myocardial infarction and stroke. This study aims to look at patients with     hyperglycaemia and reduce their blood sugar levels using differing combinations of     subcutaneous and intravenous insulin.   "
175327|NCT00135083|"     The purpose of this study is to show the non-inferiority of insulin glulisine administered     with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c     (HbA1c), from baseline to study week 24.   "
175298|NCT00129012|"     Non-small cell lung cancer (NSCLC) is a disease that often cannot be surgically operated on.     As a result, treating the tumor with radiation has become the main standard of treatment.     Radiation therapy though, is limited by various factors, including the difficulty in properly     imaging the lung tumor since the lung can move up to 4 cm between breathing in and out.     Consequently, a radiation oncologist must consider a larger area of the lung to treat with     radiation - increasing the amount of normal tissue exposed to harmful rays and therefore     leading to increased side-effects. Two techniques being explored into improving tumor     management while minimizing the side effects in NSCLC are breath-held gating and tomotherapy.     Breath-held gating is a technique for consistently imaging the tumor at the right moment in a     patient's breathing cycle - decreasing the normal tissue exposed to harmful radiation.     Tomotherapy, a new technique in delivering radiation, will further allow the investigators to     focus treatment on the tumor and exclude more normal tissues. Therefore, they hope that these     methods will prove to be a better way in treating people with NSCLC.   "
175293|NCT00128947|"     This study will examine how people differ in the way their bodies process and eliminate     mycophenolate mofetil (MMF), a drug that is used to treat problems affecting the eye and     immune system and to prevent organ rejection in transplant patients. MMF is metabolized by a     group of enzymes called UGTs, each of which is made by a different gene. This study will     investigate whether people with different UGT genes differ in how well their bodies use and     remove MMF. The results may help scientists learn the best way to give MMF to patients.      Normal healthy volunteers between 18 and 55 years of age may be eligible for this study.     Candidates are screened with a medical history, physical examination, and blood and urine     tests, including a blood test for analysis of genes that control and regulate UGTs. Pregnant     women and nursing mothers are excluded from the study. Women who are able to have a child and     men who can father a child must either abstain from sex or use two reliable forms of birth     control during the study and for 3 months after its completion.      Participants come to the NIH Clinical Center at 6:30 a.m. on the first day of the study and     stay in the outpatient clinic for 12 hours. The next 4 mornings, they return to the Clinical     Center for a single blood collection. The procedures for the 5 days are as follows:      Day 1      Upon arrival at the Clinical Center a catheter is inserted into the subject's arm vein. At     7:00 AM, the subject takes one dose of MMF by mouth with a glass of water. Small blood     samples are collected through the catheter before the MMF dose and again at 0.5, 1, 1.5, 2,     3, 4, 6, 8, 10, and 12 hours after taking the drug. Heart rate and blood pressure are     measured before the blood collection and then every 4 hours. After the last blood sample is     collected, the volunteer can return home.      Days 2-5      Volunteers come to the Clinical Center at 7:00 AM on study days 2, 3, 4, and 5 for a single     blood draw, collected using a needle.      Volunteers are contacted by telephone 1, 2, and 3 months after completing the study to see     how they are doing and to check on their pregnancy status and use of appropriate birth     control.   "
175294|NCT00128960|"     This study will evaluate the long-term functional status, psychosocial adjustment and quality     of life of patients with different types of diseases and conditions who have had an     allogeneic (donor) stem cell transplant. Information from this study may help patients and     families know better what they may expect long-term after transplant and will help health     care workers improve services to aid in patients' recovery.      People 18 years of age or older who have had an allogeneic stem cell transplant three or more     years before the start of this study may be eligible to participate.      Participants complete a series of questionnaires once a year for three years. The     questionnaires take about 40 minutes to complete and include information on patient     demographics, patients' physical, social, and emotional functioning, spiritual well being,     pain, mental health, general health, fatigue, and other areas of health-related quality of     life. The questionnaires are completed at home or during normally scheduled follow-up visits     to the NIH.   "
175295|NCT00128973|"     This study will evaluate patients with abnormal immune function that results in recurrent or     unusual infections or chronic inflammation. This may include inherited conditions, such as     X-linked severe combined immunodeficiency (XSCID), chronic granulomatous disease (CGD), and     leukocyte adhesion deficiency (LAD), or conditions resulting from outside factors, such as     graft-versus-host disease (GVHD). The information from this study will be used to establish     the pattern and pace of change of the disease and to help develop new treatments. The period     of observation and study following enrollment in this study may be for up to one year. In     addition these studies may provide the medical information needed to determine eligibility     for enrollment in other clinical study protocols and more prolonged follow up.      Patients of any age with abnormal immune function who have recurrent or unusual infections,     whose blood tests show evidence of immune dysfunction, or who have GVHD, XSCID, CGD or LAD     may be eligible for this study. Patients' parents, siblings, grandparents, children, aunts,     uncles and first cousins of any age also may be included. Healthy normal volunteers between     18 and 85 years of age are recruited as controls.      Normal volunteers undergo a physical examination and provide blood, saliva, and urine samples     for immune function studies. Patients' family members provide a medical history, have a     physical examination, and give blood and urine samples, and possibly a saliva sample. The     samples are used for genetic and routine laboratory studies. Investigators may request tissue     samples, such as biopsy specimens, previously removed for medical reasons to be sent to NIH     for study. Patients undergo the following tests and procedures:        1. Medical history and physical examination.        2. Blood and urine tests, including analysis for genes involved in immune disorders.        3. Buccal smear (in some patients) for genetic studies. This involves scraping the lining          of the mouth near the cheek.        4. Specialized tests to evaluate specific conditions in patients who have an immune          disorder that might affect lung function, gum infections or eye problems. These may          include chest x-ray, CT scan, breathing function test, dental, eye, and hearing          examinations.        5. Follow-up visits of patients with immune problems may occur at 6 months and at one year          after the first visit (or more frequently if medically required) to include:             -  Medical history update             -  Physical examination             -  Follow-up on abnormal test results and medical treatments initiated at NIH             -  Collection of blood, saliva, urine, or wound drainage samples for repeat immune               function studies             -  Tissue study of specimens removed for medical reasons at other institutions besides               NIH   "
175296|NCT00128986|"     Although malignant brain tumors are the most common type of primary brain tumor, there are a     number of other benign brain tumors that exist. Many difficulties exist with treating these     tumors that have led to controversies in the best treatment. A common issue among these brain     tumors is the risk of long term side effects from treatment. What limits the use of curative     radiation therapy is the ability to deliver a maximal dose to the tumor while minimizing the     amount of radiation to the normal structures in the brain. A new method of delivering     radiation, called tomotherapy, has been acquired at the Cross Cancer Institute (CCI) and will     be used in this study. It has the ability to deliver a high dose of radiation to the tumor     while minimizing the amount of radiation to normal brain structures. This study will use this     method of radiation therapy to deliver radiation and see if the long term side effects from     radiation therapy can be reduced.   "
175297|NCT00128999|"     Lung cancer is the leading cause of cancer-related mortality in the United States (US) and     Canada. Because of the high incidence and mortality of this disease, small improvements in     the management of this disease translates into large numbers of patients having improved     outcomes after treatment. Radiation therapy is widely used to treat patients with lung     cancer. However, the radiation dose to the tumor has been limited by the proximity of normal     structures to the tumor, such as the lung, the spinal cord and the esophagus. The normal     structures must not be exposed to excessive radiation doses. A new technique, called     intensity-modulated radiotherapy delivers radiation to tumors such that the normal structures     around the tumor are exposed to less radiation than previously achievable. This technique is     already used to treat head and neck cancers. This study will use this technique to deliver     more intensified radiation to the lung tumor after the patient receives two cycles of     chemotherapy. A new imaging technique, called positron emission tomography (PET), has been     found to be more sensitive and specific at detecting the extent of the tumor in the lung than     the older imaging technique of computed tomography (CT). This study will use both the PET and     CT to target the radiation beams. Following treatment, the patients will be followed up to     assess the side effects of normal tissues and response of the tumor to the treatment.   "
175328|NCT00135096|"     The purpose of this study is to compare the change in weight from baseline to study week 52     in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal     Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.   "
175344|NCT00137358|"     Investigator has since decided not to pursue this protocol further. No patients were     enrolled.      This study is to determine the maximum tolerated dose of external beam radiation to the     para-aortic lymph nodes using intensity modulated radiation therapy (IMRT).      This protocol will test the hypothesis that the use of IMRT and amifostine will decrease GI     toxicity and therefore allow the radiation dose to the para-aortic lymph nodes to be safely     escalated.   "
175299|NCT00129025|"     Many patients with localized prostate cancer choose radiotherapy for treatment. Recent     improvements in technology have lead to better outcomes with less side effects and better     disease control rates by allowing high doses of radiation to be delivered to the cancer with     lower doses to surrounding healthy tissues. Currently patients are required to attend daily     treatments over seven to eight weeks which can be costly and disruptive for patients,     especially those not living close to a cancer centre.      There is recent research that suggests that the same or better outcomes might be achieved in     prostate cancer by delivering a smaller number of treatments, but with a higher dose of     radiation given on each visit, over a shorter time than the usual seven to eight weeks.      In this study the investigators propose to treat patients with prostate cancer using 16     treatments over four weeks, thus reducing the number of visits to the cancer centre for     treatment by 50%.   "
175300|NCT00129038|"     The primary objective of this study is to assess whether adding modified-release dipyridamole     to aspirin (Asasantin Retard) has measurable effects on markers of platelet function (for     example, platelet aggregation) in patients with cardiovascular disease who are known to be     resistant to aspirin alone   "
175301|NCT00129051|"     Radiation treatment is often used to treat cancer that has spread to the abdomen. It can be     very effective at relieving symptoms such as pain, but the radiotherapy itself can cause     side-effects such as cramping and diarrhea. This study will investigate whether it is     possible to reduce the unwanted side-effects of radiotherapy with a new technology called     helical tomotherapy. Tomotherapy is a new way to deliver radiation in a much more accurate     fashion than is currently done, and with less radiation being delivered to normal tissues     around the tumor. This study will involve the treatment of 20 patients, who have a spread of     their cancer within the abdomen and pelvis, using helical tomotherapy. The dose and energy of     radiation will be the same as is currently used - only the delivery system is different. The     purpose is to assure that tomotherapy is a safe way to deliver radiation treatment and to     investigate whether it will reduce the toxicity of radiation treatment in these patients.     Patients will be treated in groups of three until all 20 have been treated. The toxicity of     treatment will be measured with a questionnaire for each one. If any unexpected severe     treatment complications occur, further accrual will stop.   "
175302|NCT00129064|"     An electronic referral application will be developed and integrated into the existing     outpatient information system. The primary goal of this software is to improve the quality     and coordination of patient care by increasing physician-to-physician communication. The     investigators anticipate that improved communications will also enhance physician and patient     satisfaction and provide cost savings. These outcomes will be formally evaluated following     implementation of the application.   "
175303|NCT00129077|"     The purpose of this study is to identify the incidence of scratches on the surface of the eye     in children who cannot blink due to medication use and to identify how best to reduce the     risk of a scratch on the surface of the eye when patients are using specific medicines.   "
175304|NCT00129090|"     According to amendment 3 this study addresses the question if intensification of     administration of rituximab in standard treatment for patients with newly diagnosed     aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better     time to treatment failure (TTTF)   "
175305|NCT00129116|"     This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine     and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed     meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age.     Antibody persistence and immune responses to booster vaccinations were additionally assessed     at 12 to 18 months of age.   "
175306|NCT00129129|"     This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT     vaccine compared to a control group receiving licensed Hib conjugate vaccine, each     administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups     A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.      The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a     booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age.     The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to     receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.   "
175307|NCT00134810|"     The main purpose of this study is to determine which is the best dose of a drug known as     Dysport to give when treating one's type of upper back pain. The study will also examine the     side effects of this treatment and its overall effect on one's disorder.   "
175308|NCT00134823|"     This study includes four projects aimed to improve the quality and safety of pediatric care     through the implementation of four clinical decision support services in the electronic     health record (EHR). The four projects will measure the effect of each clinical decision     support feature including: weight-based dosing; smart forms for chronic conditions; guideline     reminders; and a results manager to track abnormal lab result follow-up.      Hypothesis: Implementation of the clinical decision support features will decrease medication     errors and adverse drug events, assist physicians in adhering to clinical practice guidelines     and protocols for certain chronic illnesses, improve physician follow-up for abnormal lab     results, and overall improve the safety and quality of pediatric clinical practice.   "
175329|NCT00135109|"     This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.)     to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with     diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to one of     three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful     distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average     pain intensity of greater than or equal to 4 on an 11-point Likert scale (0-10 scale) during     the 7 day period prior to the start of treatment.      To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a     diary to record their daily pain intensity (morning and evening; and pain interference with     sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and     subjects' quality of life will be investigated. In addition, the safety and tolerability of     the different doses of lacosamide will be investigated.   "
175787|NCT00135447|"     The purpose of this study is to find out the frequency of the I50L substitution among     patients experiencing treatment failure on an atazanavir-containing regimen.   "
175309|NCT00134836|"     It is recognized that a significant proportion of seniors over 75 years of age are at risk of     functional decline, and thus of institutionalization and death. The investigators at McMaster     University Medical Centre, are conducting is a randomized controlled trial of a preventive     primary care outreach (PPCO) service provided to high risk seniors living in the community.     The goal of this service is to identify unrecognized problems and individuals at increased     risk and to link individuals to care. This preventive primary care service is provided by     nurse case managers. The investigators have recruited patients through their family     physicians who work in primary care networks. The investigators are screening all seniors     aged 75 and over within these practices. The sample includes seniors aged 75 and over who are     identified to be at risk according to the Sherbrooke Postal Questionnaire. Patients are     randomly allocated to intervention and control groups. A research assistant, who is blind to     group allocation, will collect data from seniors at baseline, six months, and at the end of     one year.      Outcome measures include health-related quality of life (quality adjusted life years     [QALYs]), health and social service utilization and costs, mortality, institutionalization,     functional status, and perceived health status.      Primary Hypothesis:      The intervention compared to usual care will result in higher health-related quality of life.      Secondary Hypotheses:      Compared to usual care, the PPCO intervention will result in:        -  the same or lower costs associated with service utilization;        -  less functional decline;        -  reduced mortality;        -  lower rates of institutionalization; and        -  better self-rated health.   "
175310|NCT00134849|"     This study is a retrospective database review of primary care appointments of patients'     charts with new diagnoses of hypertension.   "
175311|NCT00134875|"     Buprenorphine, a treatment for opioid dependence, can be mixed with another drug, naloxone,     to limit abuse potential. Parenteral administration (intravenous or intramuscular injection)     of buprenorphine/naloxone causes withdrawal symptoms in opioid dependent individuals.     However, naloxone does not cause withdrawal symptoms in non-dependent opioid abusers. This     study will investigate whether naloxone decreases the opioid agonist effect from injected     buprenorphine, hence decreasing the abuse potential of buprenorphine/naloxone, in     non-dependent opioid abusers.   "
175312|NCT00134888|"     Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse     potential. The purpose of this study is to examine the effectiveness of     buprenorphine/naloxone that is given at less than daily intervals, in order to prevent     withdrawal symptoms associated with stopping opioid abuse.   "
175313|NCT00134901|"     Cocaine is one of the most widely abused drugs in the United States. Memantine is a type of     drug called an NMDA receptor antagonist. It works by decreasing normal excitement in the     brain. NMDA receptor antagonists have shown to reduce cocaine-induced dopamine release in     animal models, as well as lessen conditioned cocaine cues. The purpose of this study is to     determine the effectiveness of memantine in preventing relapse to cocaine use in cocaine     dependent individuals. In addition, this study will determine whether memantine produces     better results than a placebo in decreasing cocaine craving, psychological symptoms,     functional impairment, and discontinuation of treatment in cocaine dependent individuals.   "
175314|NCT00134914|"     Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to     buprenorphine in order to limit the abuse potential that is commonly associated with     buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone     when given through different routes and at different doses.   "
175315|NCT00134927|"     Since 1996, the nicotine patch has been re-classified from prescription to over-the-counter     (OTC) status in the United States. Little is known about how the public uses the OTC nicotine     patch due to lack of monitoring. The purpose of this observational study is to describe the     characteristics of consumers who purchase OTC nicotine patches from community pharmacies and     to determine the factors associated with the appropriate use of nicotine patches.   "
175316|NCT00134940|"     The purpose of this observational protocol is to evaluate the use of everolimus in routine     clinical practice for heart transplants.      Primary outcome measures: incidence of acute rejection episodes Secondary outcomes: safety   "
175317|NCT00134953|"     This study is designed to investigate the efficacy and safety of rivastigmine compared with     placebo in patients with mild cognitive impairment (MCI).   "
175318|NCT00134966|"     The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone     in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy     in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit     than immediate release carbidopa/levodopa administered at the same levodopa dosage level of     100 mg three times a day (t.i.d.).   "
175319|NCT00134979|"     This study is not being conducted in the United States.      This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day     (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease     (COPD). This study is also designed to compare the efficacy and safety of therapy with     formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.)     compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and     efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).   "
175320|NCT00134992|"     The objective of this trial was to confirm the tolerability of prednisolone acetate 0.5% eye     drops by testing the hypothesis that the ocular safety and tolerability of prednisolone     acetate 0.5% eye drops are equivalent to vehicle. Thus healthy volunteers have been selected     and have been treated by using a crossover design.   "
175321|NCT00135005|"     This study is an open-label, multicenter, Phase I dose-escalation study of the combination of     AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed     to determine the Phase II dose of AMN107 and imatinib when administered together in patients     with imatinib-resistant GIST, and to characterize the safety, tolerability and     pharmacokinetic (PK) profile of this combination.   "
175322|NCT00135018|"     This study will investigate whether cyclooxygenase inhibition with celecoxib will add any     benefit to preoperative chemotherapy alone for breast cancer patients.   "
175323|NCT00135031|"     The purpose of this study was to determine the dose-ranging efficacy and safety profile of     encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome     (IBS).   "
175335|NCT00137241|"     The primary objectives for this study are to develop an estimate of the prevalence of health     literacy at four geographically diverse Veterans Affairs Medical Centers (Minneapolis,     Portland, Durham, and West Los Angeles), and for specific groups based on age, race,     education, and geographic location. The investigators' secondary objectives are to illustrate     the potential significance of poor health literacy by linking estimates for those over 50     years old to colorectal cancer (CRC) screening data and examining variation in screening     rates by health literacy levels. The investigators expect that people with lower health     literacy skills will be less adherent to CRC screening guidelines.   "
175336|NCT00137254|"     The purpose of this study is to examine the effects of insulin on helping burn patients     recover faster from their burns.   "
175337|NCT00137267|"     Surveys suggest that up to 80% of veterans with a persistent mental illness have a     co-occurring substance use disorder. Substance abuse among this population is problematic and     often results in poor engagement in treatment and thus, frequent hospitalizations and an     unstable illness course. Regarding treatment engagement, data from a VA New Jersey facility     indicated that 50% of those veterans discharged from the acute psychiatric hospital unit to     outpatient care did not attend their initial screening appointment and another 30% dropped     out within six weeks. To assist with the transition from inpatient to outpatient care, we     previously developed an eight-week augmentation intervention entitled, Time-Limited Case     Management (TLC). TLC integrates evidence-based interventions of 1) Dual Recovery Therapy; 2)     Critical Time Intervention Case Management along with 3) Peer Support with the goal of     assisting individuals with the transition from inpatient to outpatient care.   "
175338|NCT00137280|"     This project evaluates the implementation and effectiveness of a care model to improve     treatment for schizophrenia within the context of diverse VA practices and priorities. The     project provides information to VA clinicians and managers about Veterans with schizophrenia     or schizoaffective disorder who are overweight and/or who would like to return to competitive     work. The project facilitates reorganization of care practices in order to get veterans     needed and desired services around wellness and work. The project creates a platform that     other clinical and research interventions can build upon to improve care, and is designed to     inform a national strategy for implementing evidence-based care in schizophrenia.   "
175339|NCT00137293|"     The purpose of this study is to learn the effects of a test drug on heart rhythm, and to     provide additional data to see if the test drug is well tolerated and safe.   "
175340|NCT00137306|"     Comorbid depression has been consistently linked to worse outcomes for patients in substance     abuse treatment programs. Practice guidelines recommend pharmacotherapy for comorbid     depression if symptoms persist after a 4-week wash-out period for detoxification (e.g.,     Veterans Health Administration; American Psychiatric Association). Medications may be     considered earlier if a patient has current symptoms and a history of major depressive     disorder (MDD) during periods of sobriety. Current efficacy data suggest that antidepressant     medication can improve both depression and substance use outcomes among comorbid patients     Guideline-concordant use of antidepressant medication for persons with comorbid substance use     and depressive disorders, however, is not routine in many VA substance abuse treatment     settings.   "
175341|NCT00137319|"     This study will see if a special piece of equipment can help burn patients who have been in     bed for a long time to get out of bed without feeling dizzy or faint.   "
175342|NCT00137332|"     The purpose of this study is to learn the effects of a test drug on heart rhythms, which may     become life-threatening if left untreated, and to provide data to see if the drug is well     tolerated and safe.   "
175343|NCT00137345|"     The purpose of this study is to determine if one drug is superior to another with regard to     safety and the preservation of renal function after a kidney transplant.   "
175346|NCT00137384|"     This study will use various methods to measure the activity of the motor cortex (the part of     the brain that controls movements) in order to learn more about focal hand dystonia. Patients     with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or     abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or     face, is involved.      Patients with focal hand dystonia and healthy normal volunteers between 18 and 65 years of     age may be eligible for this study. Each candidate is screened with a medical history,     physical examination and questionnaire. Participants undergo the following procedures:      Finger Movement Tasks      Subjects perform two finger movement tasks. In the first part of the study, they move their     index finger repetitively from side to side at 10-second intervals for a total of 200     movements in four blocks of 50 at a time. In the second part of the study, subjects touch     their thumb to the other four fingers in sequence from 1, 2, 3 and 4, while a metronome beats     2 times per second to help time the movements. This sequence is repeated for a total of 200     movements in four blocks of 50 at a time.      Electroencephalography      This test records brain waves. Electrodes (metal discs) are placed on the scalp with an     electrode cap, a paste or a glue-like substance. The spaces between the electrodes and the     scalp are filled with a gel that conducts electrical activity. Brain waves are recorded while     the subject performs a finger movement task, as described above.      Magnetoencephalography      MEG records magnetic field changes produced by brain activity. During the test, the subjects     are seated in the MEG recording room and a cone containing magnetic field detectors is     lowered onto their head. The recording may be made while the subject performs a finger task.      Electromyography      Electromyography (EMG) measures the electrical activity of muscles. This study uses surface     EMG, in which small metal disks filled with a conductive gel are taped to the skin on the     finger.      Magnetic resonance imaging      MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The     patient lies on a table that can slide in and out of the scanner (a narrow metal cylinder),     wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning.     Most scans last between 45 and 90 minutes. Subjects may be asked to lie still for up to 30     minutes at a time, and can communicate with the MRI staff at all times during the procedure.      Questionnaire      This questionnaire is designed to detect any sources of discomfort the subject may have     experienced during the study.   "
175347|NCT00137397|"     The main aim of the study is to investigate whether taking Tolterodine for overactive bladder     symptoms can reduce the thickness of the bladder wall, as measured by intra-vaginal     ultrasound. This will help doctors to understand whether there is a link between changes in     the thickness of the bladder wall and progression of symptoms.   "
175348|NCT00137410|"     This is a phase III, multicentre, randomized, double blind, parallel-group, pilot study     designed to compare a long term (12 weeks) versus a short term (2 weeks) treatment with     celecoxib 200 mg/die in treatment and prevention of new flare in patients with osteoarthritis     of the knee.   "
175349|NCT00137423|"     To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic     renal cell carcinoma (RCC) when administered in a continuous treatment regimen   "
175350|NCT00137436|"     This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in     combination with docetaxel and prednisone for the first-line treatment of metastatic     hormone-refractory prostate cancer (mHRPC).   "
175353|NCT00137475|"     Radiotherapy is the primary treatment modality or an important adjunct treatment for many     patients with H&N carcinoma. Local control is directly related to dose and to the technical     accuracy with which the dose is delivered to the target volume. Traditional radiotherapy     techniques result in significant doses being delivered to normal tissues adjacent to the     target, including the spinal cord and salivary glands. This leaves the patient with     significant acute and late normal tissue toxicity that impacts on both the ability to     tolerate the actual treatment and on the patient's long-term quality of life. Recently, the     investigators have used static conformal multisegmental intensity modulated radiotherapy     (IMRT) for a comprehensive irradiation of head and neck cancer with dose sparing of     uninvolved tissues. This has resulted in substantial preservation of major salivary gland     function in many patients with primary sites in the oral pharynx, oral cavity, nasopharynx,     and pyriform sinus. While the investigators' results to date have shown promising     preservation of salivary flow, they do not know whether patients treated with IMRT have     similar local control rates as those treated with standard radiotherapy. Some investigators     have raised the concern that by giving a low radiation dose to areas adjacent to the target     volume there is a risk of undertreating the disease. On the other hand, the IMRT delivered     with this protocol (called simultaneous integrated boost, or SIB) may improve local control     rates by delivering the same biologically effective dose in a shorter overall time period.     This is a phase I/II trial which seeks to establish the efficacy of IMRT for H&N cancer     treatment, and to further investigate the relationship between radiation dose to the parotid     glands, salivary flow, and quality of life.   "
175354|NCT00137488|"     The low grade glioma (LGG) is a type of brain tumor which is generally more common in younger     age group patients. Most patients with LGG undergo surgery which is mostly incomplete due to     concern about loss of function. This is an incurable disease. More than half of these     patients progress to a higher grade with a worse outcome within five years of their diagnosis     and only one-third survive for up to ten years. Post-operative radiation treatment improves     local control without survival advantage. Efforts are being made without great success to     select the patients with a higher risk of progression based on physical characteristics and     histological features.      Tumor vascularity is thought to be the key element in tumor progression. Tremendous progress     has been made in functional imaging by using magnetic resonance imaging (MRI) 3-Tesla (3T)     and in biotechnology which can be used to investigate angiogenic gene profiles in order to     identify gene signature for these tumors. In this study the investigators are proposing that     patients of LGG with a higher risk of tumor progression may be selected by functional imaging     and angiogenic profiles. These higher risk patients may be candidates for post-operative     radiation in the future with a potential survival benefit.   "
175365|NCT00137631|"     The purpose of this program evaluation is to determine whether the Many Men, Many Voices     HIV/STD prevention intervention is effective in reducing HIV sex risk behaviors and     increasing HIV testing among African-American men who have sex with men (MSM), who may or may     not self-identify as gay. The intent of this program is to support the evaluation of an     existing intervention and provide feedback to the implementing organization for improved     program effectiveness, not to conduct research.   "
175625|NCT00141193|"     This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial     to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the     occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37     (Year 3) of study drug administration.   "
175355|NCT00137501|"     Preterm birth is one of the most important causes of perinatal morbidity and mortality     worldwide. Prevention and treatment of preterm labor is important, not as an end in itself,     but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs     used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most     widely used tocolytic at the American University of Beirut Medical Center despite the fact     that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently     available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm     labor to the extent that some authorities are recommending abandoning it for routine use as a     tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in     smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe     alternative tocolytic agent for the management of preterm labor after several studies have     shown that the use of nifedipine in comparison with other tocolytics is associated with a     more frequent successful prolongation of pregnancy, resulting in significantly fewer     admissions of newborns to the neonatal intensive care unit, and is associated with a lower     incidence of respiratory distress syndrome. The unequivocal impact of this method of     tocolysis on short term postponement of delivery and the opportunity that this provides for     affecting in-utero transfer and steroid administration has prompted many investigators to     recommend focusing future trials on testing different dose regimens of nifedipine. To the     best of the investigators' knowledge, no study comparing two different dose regimens of     nifedipine has been previously published in the literature. The objective of their study is     to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients     admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In     addition, the investigators' study will try to assess the safety profile of the 2 dose     regimens on the mother and the neonate by assessing a selected number of outcome variables.     The data generated will be used to change their protocol for managing patients presenting     with threatened preterm delivery and will fill the existing gap regarding the most effective     and safest dose regimen of nifedipine in such patients.   "
175356|NCT00137514|"     This study will evaluate the efficacy of the treatment recommended by the National Malaria     Programme in Guinea-Bissau as compared to a higher dose of chloroquine and to another     anti-malarial drug, amodiaquine. The genetic basis of the parasites for developing resistance     will be examined. Children coming to Bandim Health Centre with symptoms of malaria and a     positive malaria test will be included. The children will be visited and malaria films will     be obtained weekly until day 35. In case of a reappearance of parasites the children will be     re-treated with sulfadoxine/pyrimethamine.   "
175357|NCT00137527|"     The purpose of this study is to determine whether intraoperative brain oxygenation monitoring     in cardiac surgery patients is effective in reducing postoperative neurologic and     neurocognitive dysfunction.   "
175358|NCT00137540|"     The objective of this multicenter randomized study is to establish the effectiveness of     treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with     anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation,     using the NaviStar® ThermoCool® catheter and the CARTO™ EP Navigation System. Effectiveness     will be determined by comparing chronic success of ablation therapy versus anti-arrhythmic     drug treatment, defined as patients with an absence of atrial tachycardias during 24 months     of follow-up as determined by 7-days Holter and transtelephonic monitoring, and by 12-lead     electrocardiogram (ECG) recordings.   "
184475|NCT00257673|"     The purpose of this study is to determine in a 12-week treatment study if MEM 1003 is a safe     and effective treatment for patients with mild to moderate Alzheimer's disease.   "
175359|NCT00137553|"     Children participating in a study evaluating the efficacy of chloroquine and amodiaquine for     the treatment of malaria will, if getting malaria during follow-up, be re-treated with     sulfadoxine-pyrimethamine (SP) in accordance with the recommendations of the National Malaria     Programme.      To compare the actual efficacy of SP with that in 1995 - 1996 we, the investigators of the     Bandim Health Project, will visit these children once a week for 5 weeks. A finger prick     blood sample will be collected for a malaria test.      Children with malaria during follow-up will be treated according to the guidelines of the     Bandim Health Centre.   "
175360|NCT00137566|"     The National Malaria Programme in Guinea-Bissau recommends paracetamol for all children     treated for malaria. We, the investigators of the Bandim Health Project, want to evaluate     whether this treatment has any effect on:        -  the well-being of the child;        -  the parasite clearance time; and        -  the rate of a re-appearance of parasites during 35 days of follow-up.      Children presenting at Bandim Health Centre with malaria will be treated with chloroquine     plus paracetamol or chloroquine plus placebo. Blood samples will be obtained daily for the     first 4 days and then once a week until day 35.   "
175361|NCT00137579|"     Until now, the best administration route of the anti-flu vaccine for patients receiving long     term oral anticoagulation therapy has been the subcutaneous one; the intramuscular route has     not been recommended because it may increase the risk of muscular haematoma. Although this     practice is widely extended, no significant differences between the safety of both routes     have been found. Some authors, analysing a small group of patients, affirm that the anti-flu     vaccine can be administered safely by the intramuscular route on patients receiving long term     oral anticoagulation therapy, while a previous opinion article recommended the subcutaneous     route without any scientific evidence. Due to this, the investigators have done a clinical     trial with the aim of determining the safety and effectiveness of the flu-vaccine     intramuscular route in patients receiving long term oral anticoagulation therapy and also to     analyse the possible interactions between the vaccine and the oral anticoagulant treatment.   "
175362|NCT00137592|"     This community based participatory research study involves multicomponent educational     interventions. Telephone interviews and focus groups of persons who are residents of the High     Plains region of Colorado will be conducted. A card study will also be carried out to collect     limited data about colorectal cancer screening in primary care practices. The multicomponent     intervention approaches (e.g., small media and group education) consist of educational     materials about routine colorectal cancer screening.   "
175363|NCT00137605|"     The purpose of this study is to determine whether people who are HIV-positive respond better     to a vaccine for pneumonia-related disease when they are immunized immediately, or when     immunization is delayed until the immune system has improved to a certain level. The study     will also compare the effectiveness of polysaccharide and heptavalent vaccines.   "
175364|NCT00137618|"     This project is a community based participatory research collaboration that will enable     increased informed decision making (IDM) for prostate cancer screening in Hispanic and     African-American men. This will be done through the development of an educational program     implemented in the communities of El Paso, Texas and Columbia, South Carolina to provide     accurate information to men regarding prostate cancer screening in order to enable them to     make informed decisions.   "
175382|NCT00137852|"     This is a study for patients with resectable, locally advanced esophageal cancer. There is     evidence to suggest that celecoxib in combination with cisplatin and irinotecan (CPT-11) may     work well with radiation therapy to kill cancer cells. The primary goal is to develop a     well-tolerated cancer treatment that has an acceptable response rate.   "
175366|NCT00137644|"     The purpose of this program evaluation is to determine whether the Preventing AIDS Through     Live Movement and Sound (PALMS) group-level intervention is effective in reducing HIV sex     risk behaviors and increasing HIV testing of high-risk, incarcerated or adjudicated youth.     The intent of this program is to support the evaluation of an existing intervention and     provide feedback to the implementing organization for improved program effectiveness, not to     conduct research.   "
175367|NCT00137657|"     At least three studies in sub-Saharan Africa have demonstrated a decrease in morbidity or     mortality among HIV-infected adults who took daily cotrimoxazole (trimethoprim     sulfamethoxazole) [CTX] prophylaxis. Because of the demonstrated beneficial effect, high     tolerability and low cost of CTX, the United Nations Programme on HIV/AIDS (UNAIDS)     recommends that HIV-infected persons with symptomatic HIV or depressed CD4 counts receive     daily CTX. The effect of this recommendation on subsequent development of antimicrobial     resistance to antifolates among important pathogens needs to be evaluated. The investigators     measured the change in the prevalence of markers of antifolate resistance among P.     falciparum, and the change in the prevalence of CTX resistance among S. pneumoniae, and E.     coli in HIV-infected individuals receiving CTX daily prophylaxis. In addition, the     investigators measured the change in the prevalence of naso-pharyngeal or oro-pharyngeal     carriage of CTX resistant S. pneumoniae among children living in households where an     HIV-infected adult was receiving CTX daily prophylaxis.   "
175368|NCT00137670|"     The purpose of this study is to assess the effectiveness of a brief 23-minute video-based     educational waiting room intervention to reduce incident STD and high risk behavior among STD     patients attending STD clinics in three United States (U.S.) cities.   "
175369|NCT00137683|"     The purpose of this project is to conduct a community-based intervention and evaluate the     independent and combined effects of two intervention strategies on primary and secondary     prevention of colorectal cancer (CRC) among members of rural Appalachian churches. The     sampling frame consists of all of the churches in a 7 county area of western West Virginia.     Eligible churches will have at least 180 active members, will not share a common pastor, and     will have no CRC control activities. Using a 2x2 experimental design, churches will be     divided into two separate clusters, those with and without an existing parish nurse program.     Then churches from each cluster will be randomized to one of two conditions, a natural helper     or a control condition.   "
175387|NCT00137917|"     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3     doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a     0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2     doses of Havrix™ (0-6 months) and Meningitec™ (month 1).   "
175370|NCT00137696|"     As poliovirus eradication progresses rapidly, strategies to discontinue oral poliovirus     vaccination need to be established. One strategy would be to use inactivated poliovirus     vaccine (IPV) transitionally, and this has already occurred in the United States. It is not     clear, however, if 3 doses of IPV provide sufficient immunogenicity when administered     according to World Health Organization (WHO)/Expanded Programme on Immunization (EPI)     schedule in a tropical, developing area where no wild-poliovirus circulates.      Puerto Rico will be the study site for this randomized clinical trial. Healthy infants will     be identified at birth in a hospital-system, enrolled within 4 weeks of birth, and randomized     into one of two arms: United States of America (U.S.A.) schedule (8, 16, 24 weeks/2, 4, 6     months) or WHO schedule (6, 10, 14 weeks). Both groups will receive IPV at visits 1, 2 and 3.     Infants will receive all age-appropriate EPI childhood vaccinations along with IPV, to     decrease confusion and inconvenience to the parent. Serum will be collected twice, at visit 1     and visit 4 (30-45 days after IPV-3), to measure antibody titers. Sera will be measured for     neutralizing antibodies at the Centers for Disease Control (CDC). Based on the lowest     seroconversion rate estimate of 85%, and to have a probability of .80 that the estimate from     this study is in error by no more than 10%, the investigators will need to enroll 220 infants     in each arm. To compensate for attrition and retain statistical power, the investigators plan     to enroll up to 250 infants in each arm. This study is expected to require at least 20 months     to complete. Results will provide valuable and timely information applicable to global polio     eradication efforts. Any participant found not to be protected after 3 doses of IPV will be     given a booster at 9-12 months. Results will provide valuable and timely information     applicable to global polio eradication efforts.   "
175371|NCT00137709|"     Both sodium valproate and lamotrigine are currently used in the treatment of newly diagnosed     epilepsy. Although they appear to have similar efficacy, they have different side effects,     which have not been well studied. This study aims to compare one particular aspect of their     possible side effects, namely whether they affect certain hormonal functions.   "
175372|NCT00137722|"     Disease management is used to manage patients who have asthma and who are enrolled in a     managed care health plan. To understand the effect of disease management on asthma severity     and utilization, the investigators at Children's Mercy Hospitals and Clinics, will review     data from a Medicaid Health Maintenance Organization (HMO) to determine the number of health     plan members with different asthma severities and what their outcomes are. This will help us     to improve the service provided to these patients. The investigators wish to publish this so     that other health plans can benefit from the investigators experience.   "
175373|NCT00137735|"     The purpose of this study is to determine whether gabapentin is safe and effective in the     treatment of carpal tunnel syndrome (CTS).   "
175374|NCT00137748|"     This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the     Cleveland Clinic Foundation who are hypogammaglobulinemic.   "
175375|NCT00137761|"     The purpose of this study is to find out what activity the combination of docetaxel and     Iressa have against metastatic pancreatic cancer.   "
175376|NCT00137774|"     The purpose of this study is to determine what effects (good and bad) bevacizumab and     temozolomide have on patients with neuroendocrine tumors.   "
175377|NCT00137787|"     The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as     cefepime for the initial treatment of febrile neutropenia developed in patients with     hematologic diseases.   "
175378|NCT00137800|"     The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and     potentially as good as or better than standard chemotherapy drugs, when given to subjects     with non-small cell lung cancer, who are 70 years of age or older.   "
175379|NCT00137813|"     The purpose of this study is to determine what effects (good and bad) bevacizumab (Avastin)     and docetaxel (Taxotere), used in combination, have on metastatic gastric and esophageal     cancer.   "
175380|NCT00137826|"     The purpose of this study is to determine whether the combination of the investigational     drugs Avastin and Tarceva are effective in patients with mesothelioma who have previously     been treated with chemotherapy.   "
175381|NCT00137839|"     The purpose of this trial is to figure out what effects (good or bad) the investigational     drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated     adenocarcinoma.   "
175383|NCT00137865|"     Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the     cells of the body. Because the genes are damaged, the body is unable to produce a group of     proteins called cytokines which are used by the immune system to fight cancer and some     infections. The investigational gene transfer agent EGEN-001 (phIL-12-005/PPC) contains the     human gene for interleukin-12 [IL-12] (a cytokine) in a special carrier system designed to     enter the cells and help the body produce cytokines.      This study has two purposes; the first is to determine what different strengths of EGEN-001     can be given safely without major side effects, and the second is to see if EGEN-001 is able     to slow down the growth of ovarian cancer.   "
175384|NCT00137878|"     The purpose of this study is to determine if the addition of TNFerade™ to pre-operative     chemoradiotherapy increases the number of pathologic complete responses when compared to     pre-operative chemoradiotherapy alone as assessed following complete surgical resection of     primary rectal cancer.   "
175385|NCT00137891|"     Forty-six (46) eligible, healthy subjects who provide written informed consent will be     enrolled to participate in a 2 arm parallel group study to assess and compare the     pharmacokinetics and safety profile of Thyrogen dosed at 0.1 mg versus a modified release     formulation of recombinant human thyroid stimulating hormone (rhTSH) dosed at 0.1 mg. Ten     (10) of these subjects will have the thyroid uptake of radioiodine (123I) measured at     baseline and following their single dose of study medication. All doses will be administered     via intramuscular (IM) injection.      Following confirmation of study eligibility, subjects will be randomized in a 1:1 ratio to     receive either a single administration of 0.1 mg of Thyrogen (THYR) or 0.1 mg of the modified     release.      Randomization will be stratified by whether or not patients will have the thyroid uptake of     radioiodine (123I) measured following their single dose of study medication. Five (5)     patients in each treatment arm will have uptake measured, while 18 in each arm will not.      Each subject will have blood samples taken to determine the pharmacokinetics of serum TSH at     -12 hours and just prior to dosing and at various hours up to 14 days following the     administration of Thyrogen or the modified release formulation. In addition, for the     evaluation of pharmacodynamics, each subject will have samples of blood taken to determine     serum free T4, total T4, free T3, and total T3 at -12 hours and just prior to dosing and at     various hours up to 14 days following the administration of study treatments.      All subjects will undergo a 12-lead electrocardiogram (ECG) just prior to dose administration     and 1, 2, 3, 4, 5, 7, 10 and 14 days following study treatment administration. In addition,     subjects will undergo 24 hours of Holter monitoring at baseline and four (4) consecutive     24-hour Holter monitoring sessions post treatment to yield a total of 96 hours of continuous     monitoring of cardiac function following treatment administration. All subjects will undergo     ultrasound evaluations to determine thyroid volume at baseline and 48 hours following     treatment administration.      Twenty-four hours following the administration of Thyrogen or the modified release     formulation, a subset of five (5) subjects in each treatment arm will receive a dose of 123I     prepared to be 400µCi on the day of radioiodine administration based on the utilized nuclear     pharmacy's calibration schedule. Thyroid gland uptake will be measured via a probe in these     10 subjects at 6, 24 and 48 hours following radioiodine administration.      Blood chemistry, complete blood count (CBC), urinalysis and a physical exam will be conducted     14 days after treatment administration, or at the time of early termination, as a final     safety assessment.      Each subject's duration of study participation will be approximately 4 weeks.   "
175667|NCT00141739|"     This is a clinical trial to see if the addition of etanercept to standard preventative     medicines helps in preventing two major complications of hematopoietic stem cell     transplantation (HSCT): decrease the rate of acute graft-vs-host disease (GVHD) and the risk     of death.   "
175388|NCT00137930|"     Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the     hospitalization of infants and young children in developed and developing countries and can     be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000     annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against     human rotavirus gastroenteritis. A new formulation of the vaccine, with an alternative     buffer, was developed. This study will be conducted to evaluate the new formulation compared     to the existing formulation of the HRV vaccine.   "
175389|NCT00137943|"     Parents Matter is a community-based project whose goal it is to develop and test an     intervention designed to promote effective parent-child communication about sexuality in     order to promote sexual health among adolescents.   "
175390|NCT00137956|"     The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and     quality of life information on patients enrolled in the VENT study in order to analyze the     relative cost-effectiveness of the endobronchial valve implant procedure.   "
175391|NCT00137969|"     This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to     evaluate the efficacy and safety of rituximab compared with placebo when combined with a     single stable background immunosuppressive medication in subjects with moderate to severe     systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be     evaluated at 52 weeks.   "
175392|NCT00137982|"     Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate,     conservative surgery or radical surgery. There are no data about subsequent fertility except     in a cohort study. The investigators propose to evaluate the true subsequent fertility with a     follow-up of 2 years, in a randomized controlled trial.   "
175393|NCT00137995|"     The primary objective of this study is to evaluate the efficacy and safety of induction     therapy R-ICE in comparison to R-DHAP after 3 cycles adjusted to successful mobilization of     stem cells in patients with previously treated diffuse large B-cell lymphoma CD20.      The goal is to detect a difference in mobilization adjusted response rate of 15% between     R-ICE and R-DHAP.      The other objective is to evaluate the efficacy and safety of MabThera maintenance therapy     after transplantation as measured by the event free survival.      The goal is to obtain a 15% increase of event free survival at 2 years.   "
175394|NCT00138008|"     The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in     comparison with endocrine therapy alone for PSA failure after radical prostatectomy.   "
175395|NCT00138021|"     This project seeks to evaluate the feasibility and effectiveness of combining cognitive     remediation and Supported Employment Program (SEP) services to improve work outcomes in     people with a serious mental illness who have been unable to benefit from vocational services     (i.e., acquire or maintain a job). Cognitive remediation involves treating and improving     cognitive impairments, such as memory (e.g., short-term and working memory), attention span,     or problem solving skills. It is hypothesized that cognitive remediation will significantly     improve peoples' employment outcomes in a supported employment program.   "
175436|NCT00138567|"     This is a 52-week extension to a study to assess the safety and effectiveness of     vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose     levels in people with type 2 diabetes who have not been previously treated with drug therapy     to lower their blood sugar. The purpose of the extension study is to gather data on the     long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.   "
175396|NCT00138034|"     Reocclusion of the infarct artery is observed in about 30% of patients within three months     after successful thrombolysis for acute myocardial infarction (MI). Reocclusion is associated     with an increased risk of death, reinfarction and the need for revascularization. Even in the     absence of clinical reinfarction, reocclusion results in impaired left ventricular (LV)     recovery, leaving patients at increased risk of developing heart failure in the long-term.     Prevention of reocclusion is therefore warranted. In previous trials, severity of the infarct     related stenosis was the only independent predictor of reocclusion. With a lack of clinical     predictors of reocclusion, many cardiologists therefore empirically favor routine     revascularization after successful thrombolysis.      The APRICOT-3 will be the first randomized trial in the current era of improved angioplasty     techniques to study the question of whether a routine invasive strategy after successful     thrombolysis can reduce the incidence of reocclusion and subsequently improve clinical     outcome and LV-function. After successful thrombolysis, patients will be randomized to either     a routine invasive strategy or an ischemia-guided strategy. The investigators expect to     demonstrate a lower reocclusion rate at the 6-month follow-up angiography (primary endpoint)     and fewer associated events (death, reinfarction, revascularization, admissions for heart     failure) in the routine invasive arm. In search of non-invasive parameters predictive of     reocclusion, laboratory analysis of several coagulation and inflammatory markers will be     performed. Finally, pooled analysis of all 3 APRICOT trials will focus on the identification     of clinical predictors of reocclusion that can easily be obtained by history and physical     examination.   "
175397|NCT00138047|"     The goal of the study is to rule out a harmful effect of zinc supplementation in     HIV-1-infected children. The null hypothesis is that zinc supplementation will increase     plasma HIV RNA levels.   "
175398|NCT00138060|"     This study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the     identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1     (UGT1A1) polymorphisms before the first administration.      The results of this identification determine the chemotherapy type: high-dose irinotecan or     not.   "
175399|NCT00138073|"     Skill with pulmonary artery catheter (PAC) waveform interpretation is inadequate among     physicians and nurses. We, the investigators at Massachusetts General Hospital, have     developed a web-based computer program to assist physicians and nurses in PAC waveform     interpretation. We will study the effectiveness of this program on improving the     interpretation of waveforms on a computer-based test.   "
175400|NCT00138086|"     The objective of this study is to evaluate the efficacy and the safety of Zevalin-BEAM     preparative regimen before autologous stem cell transplantation (ASCT) as measured by the     event free survival (EFS).      The goal is to obtain a 15% increase of EFS at 2 years.   "
177260|NCT00160706|"     A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn     from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an     exacerbation of Crohn's Disease.   "
175401|NCT00138099|"     The investigators' primary research objective is:        -  To determine the safety of dalteparin prophylaxis, 5,000 IU once-daily, in Intensive          Care Unit (ICU) patients based on:             -  the proportion of patients with trough anti-Xa > 0.40 IU/mL during dalteparin               prophylaxis after 3 + 1 days, 10 + 1 days, and 17 + 1 days of dalteparin               prophylaxis;             -  the risk of major bleeding during the treatment period.      The investigators' secondary research objectives are:        -  To determine the pharmacokinetic properties of dalteparin prophylaxis in ICU patients          with severe renal insufficiency;        -  To identify clinical and laboratory factors that predict an excessive anticoagulant          effect (anti-Xa > 0.10 IU/mL);        -  To estimate the relationship between trough anti-Xa levels and bleeding.      The DIRECT Pilot Study:      Before embarking on a large trial of low molecular weight heparin (LMWH) versus standard     unfractionated heparin (UFH), the DIRECT Study is needed to observe whether bioaccumulation     of LMWH occurs in ICU patients with moderate to severe renal insufficiency, and to address     potential problems with protocol implementation.   "
175402|NCT00138112|"     This is a randomized 2-arm study to compare two different times of giving the drug     vancomycin. Half of the patients will begin vancomycin two days before a bone marrow     transplant. The other half will get it as soon as they have the first fever.      Streptococci are bacteria that live in one's mouth and gut. These bacteria can escape into     the blood when the lining of the mouth and gut weakens from cancer therapy. This can make the     person who is undergoing a bone marrow transplant very sick. All patients who get this     infection are treated with antibiotics. Vancomycin is one drug that is used to treat this     bloodstream infection once it is diagnosed. Studies have shown that giving vancomycin before     a bone marrow transplant seems to prevent this infection. However, giving vancomycin too soon     may increase the chance that the kidneys will be irritated. It may also increase the chance     that other bacteria will become resistant to this drug. We, the investigators at Memorial     Sloan-Kettering Cancer Center, do not know if waiting to start vancomycin until the patient     has a first fever can also prevent this infection.   "
175403|NCT00138125|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes.     Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. It is not yet known whether giving     fulvestrant together with trastuzumab is more effective than giving fulvestrant or     trastuzumab alone in treating breast cancer.      PURPOSE: This randomized phase II trial is studying how well fulvestrant and/or trastuzumab     works as first-line therapy in treating postmenopausal women with stage IV breast cancer.   "
175404|NCT00138138|"     Fatigue is one of the most common symptoms of prostate cancer. Fatigue is a lack of energy     that makes it harder to do the things you normally do every day. Some symptoms of fatigue     are:        -  feeling tired and/or weak;        -  having less interest in activities;        -  having trouble concentrating;        -  feeling down;        -  feeling exhausted for no clear reason.      There are not many drugs that are helpful in treating fatigue. However, one group of     medications does seem to be useful. In this study, we, the investigators at Memorial     Sloan-Kettering Cancer Center, will be using a psychostimulant called Ritalin. The aim of     this study is to see if this drug is helpful in treating fatigue in prostate cancer. We are     also studying the side effects of this medication.   "
175454|NCT00138801|"     The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the     treatment of neuroborreliosis in a randomized controlled trial.   "
175405|NCT00138151|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor     is said to be resistant to chemotherapy. Giving isotretinoin and interferon alpha-2b together     with paclitaxel may reduce drug resistance and allow the tumor cells to be killed.      PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alpha-2b     together with paclitaxel works in treating patients with stage IV, recurrent, or persistent     cervical cancer.   "
175406|NCT00138164|"     RATIONALE: Biological therapies, such as denileukin diftitox, may be able to carry     cancer-killing substances directly to non-Hodgkin's lymphoma cells.      PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating     patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.   "
175407|NCT00138177|"     This phase I trial is studying the side effects and best dose of suberoylanilide hydroxamic     acid when given together with fluorouracil, leucovorin, and oxaliplatin in treating patients     with progressive metastatic or unresectable colorectal cancer or solid tumor. Drugs used in     chemotherapy, such as suberoylanilide hydroxamic acid, fluorouracil, leucovorin, and     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more     than one drug (combination chemotherapy) may kill more tumor cells.   "
175408|NCT00138203|"     This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating     patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Drugs used in     chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth.   "
175409|NCT00138216|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, vincristine, and irinotecan,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when     given together with temozolomide and vincristine in treating young patients with refractory     solid tumors.   "
175540|NCT00132197|"     The purpose of this study is to determine the effect of specialized treatment (including     cognitive therapy, social counselling and a recommendation letter to the patients' primary     care physician) on the functional level, emotional problems, and use of health care in     patients with chronic medically unexplained symptoms.   "
175410|NCT00138229|"     RATIONALE: An infusion of a patient's lymphocytes that have been treated in the laboratory to     remove certain immune cells may be an effective treatment for melanoma. Drugs, such as     cyclophosphamide and fludarabine, may suppress the immune system so that the patient's immune     cells allow the infused lymphocytes to work. Interleukin-2 may help the lymphocytes kill more     tumor cells when they are put back in the body. Giving cyclophosphamide and fludarabine     followed by an autologous lymphocyte infusion and interleukin-2 may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine     followed by an autologous lymphocyte infusion and interleukin-2 works in treating patients     with refractory or recurrent melanoma.   "
175411|NCT00138242|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin     works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity     cancer.   "
175412|NCT00138255|"     The purpose of this study is to see if the MMR and chickenpox vaccines work as well in     premature infants as in children that were carried to full term. A group of children who were     carried full-term will be matched for age, sex, and race and will be used for comparison.   "
175413|NCT00138268|"     To evaluate and standardize umbilical cord specimen collection and laboratory procedures to     evaluate cellular and serological immune responses in neonates and young infants   "
175414|NCT00138281|"     Sixty adults, ages 18-49, will be randomly assigned to receive either FluMist or Fluzone.     Some of the subjects will have participated in previous studies for these 2 vaccines. The     study will last 4 months with subject participation being 28 days. The purpose of this study     is to measure immune response to the vaccinations.   "
175415|NCT00138294|"     The main purpose of this study is to learn if influenza vaccines (live attenuated and     inactivated influenza vaccines), when given to school-aged children 4 to 18 years of age, can     stop or lessen the influenza (flu) outbreak in the community. Another purpose is to show that     vaccination of these children will significantly reduce breathing problems (in the vaccinated     children and unvaccinated people they come in contact with in the community) that require a     visit to the doctor for treatment. Another purpose is to continue to collect safety and flu     protection information on live attenuated influenza vaccine (LAIV or FluMist) given to     children. The study investigators believe that vaccination of healthy school-aged children is     an effective plan for preventing many people in the community from catching the flu. Children     will take part in the study for 5 to 10 months.   "
175416|NCT00138307|"     Malaria is a sickness passed from one person to the other by the bite of a mosquito. In areas     of frequent malaria infection, children may develop natural protection against malaria and     they are less likely to become sick or die from it as they age. The purpose of this study is     to investigate the body's natural protection against malaria in children by testing their     blood. This information may help investigators develop a malaria vaccine. The Navrongo Health     Research Centre is conducting this study in Ghana. Three hundred healthy children between the     ages of 1 and 5 years will participate in the study for 12 months. Study procedures will     include 7 field worker visits to check on the child's health and obtain a blood sample. Every     two months, a blood sample will be taken from each child to test it for strength against     malaria. Whenever a child is sick, the child will be tested for malaria.   "
175455|NCT00138814|"     This is a two arm randomized study for patients who are undergoing radiotherapy following     breast conservation surgery for breast cancer. Local recurrence of breast cancer will be     compared for patients receiving boost or no boost radiotherapy.   "
175456|NCT00138827|"     The purpose of this study is to assess whether Biotene oral care products have a benefit in     the treatment of xerostomia and mucositis when compared with conventional bicarbonate mouth     care regimes.   "
175417|NCT00138320|"     The purpose of this study to look at the antibodies (proteins from the body's infection     fighting system) in the blood of babies delivered by women who are participants in the     Herpevac Trial for Women, and who were vaccinated with either two or three doses of     (GlaxoSmithKline) GSK candidate vaccine gD2t/alum-MPL or hepatitis A vaccine. The goal of     this study is to compare the herpes or hepatitis A antibody levels of the newborns to those     of their mothers, and to see how much of the antibodies are still present in the baby at two     and six months after birth. Approximately 2 teaspoons (10 ml) of the mother's blood will be     collected at the time of delivery or within 15 days before or after delivery. Approximately 2     teaspoons of blood will be collected from the child's umbilical cord at the time of delivery,     or 1 teaspoon (3-5 ml) of the child's blood will be drawn within 15 days after birth.     Optional blood draws from babies may occur 2 and 6 months after birth.   "
175418|NCT00138333|"     The goal of the study is to find out how much mercury is in the blood, urine, and stools of     premature and low birth weight infants who have received standard childhood vaccines that are     given to all infants in Argentina. Seventy-two newborn premature and low birth weight infants     from Durand Acute General hospital will participate in this study. Each infant in the study     will need to make two visits, one at the time of vaccination and another 12 hours to 30 days     later. Urine, stool, and a small sample of blood will be taken at each visit.   "
175419|NCT00138346|"     This is a study developed by researchers from the Universidad Peruana Cayetano Heredia, the     Universidad Mayor de San Marcos and other local and foreign institutions. Researchers are     performing this research in human beings and animals, in order to determine the best way to     understand and eliminate a parasite called Echinococcus granulosus (tapeworm). The parasite     grows and develops in the dogs´ bowel. The tapeworm produces eggs which are eliminated among     the feces and remain in the environment. Individuals may accidentally ingest the eggs through     contaminated food or drinks and develop a disease called cystic hydatid disease. This disease     mainly affects the human lungs and liver. The parasite grows in the shape of a water bag and     it can jeopardize human life. It also affects sheep, goats, llamas and alpacas. The study     will enroll almost 840 volunteers who are older than 5 years of age. It will last about 3     years.   "
175541|NCT00132210|"     The purpose of this study is to determine whether pegylated interferon therapy is effective     to treat acute hepatitis C infection in HIV-coinfected individuals.   "
175421|NCT00138372|"     This is a study of 125 healthy male and female Kenyan adults aged 18 years and above, and 300     healthy male and female Kenyan infants enrolled at 1 month of age and followed to 3 years of     age. Twenty healthy adults (US residents) who have no self-reported history of Malaria     exposure, infection or travel to malaria endemic areas of the world will serve as Malaria     Naive Negative Controls. The proposed study represents a continuation of molecular and     immunologic studies done in human populations describing mechanisms of protection against     malaria infection and disease. Human investigation of those experiencing natural exposure to     malaria infections are justified since they will eventually be the target population for     testing malaria vaccine safety and efficacy.   "
175422|NCT00138385|"     The purpose of this study is to evaluate how young children's bodies learn to fight against     flu infection and to see how vaccines may help to fight against the flu. This is a Phase 4,     single-center, randomized study of the immune responses of 40 children, ages 5-9, given one     of two licensed influenza vaccines (either inactivated vaccine given in an arm muscle or     live, attenuated vaccine inhaled through the nose). Study procedures will include up to 3     blood samples. Participants will complete a diary to document any side effects experienced     following the vaccination. Participants will return to the clinic for a visit on Day 7-9 and     again 4-6 weeks following vaccination. Participants that have not been previously vaccinated     will receive a 2nd dose of vaccine. A follow up telephone call will occur 8-10 weeks     following vaccination. Total study participation will be up to 75 days.   "
175423|NCT00138398|"     The purpose of this study is to determine how the immune system changes with aging and makes     influenza a more serious illness in older people. Influenza vaccination not only can protect     people from getting the flu but also can lessen the severity of the illness. This is     particularly true for people with congestive heart failure (CHF). This research may provide     information that could eventually lead to a new laboratory test that will predict how     effective vaccination is for preventing influenza illness in older people. Volunteer     participants in this study will include the following groups: 1) healthy young adults 20 - 40     years old; 2) older adults, 60 years and older, without a history of CHF; 3) older adults, 60     years and older, with a history of CHF. All study participants will be vaccinated with the     current preparation of inactivated influenza vaccine. A small amount of blood will be drawn     before each vaccine and at 4, 10, and 16-20 weeks afterward.   "
175424|NCT00138411|"     The purpose of this study is to evaluate the safety and pharmacokinetics (how long a drug     stays in the bloodstream and how high the levels of the drug are at different times) of     ETI-204 following intravenous (IV-into a vein) injections, and to evaluate the effects that     ETI-204 may have on the pharmacokinetics of oral (by mouth) ciprofloxacin, an antibiotic     approved by the U.S. Food and Drug Administration (FDA). ETI-204 is an experimental drug (not     approved by the FDA) intended to protect against anthrax (a bacterial infection).     Approximately 36 male and female healthy volunteers ages 18 to 50 will be in this study.     Participation in this study may last up to eight weeks. Volunteers will have a single IV dose     of the ETI-204 study drug or placebo (inactive substance, and some participants will also     receive ciprofloxacin. They will stay in the Clinical Pharmacology Unit at least 36 hours     after the dose.   "
175435|NCT00138554|"     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a     single oral drug. This is a 28-week extension to a study to assess the safety and     effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels     when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels     on pioglitazone or rosiglitazone alone. The purpose of the extension study is to gather data     on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.   "
175518|NCT00139672|"     The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of     abdominal pain/discomfort associated with irritable bowel disease.   "
175425|NCT00138424|"     This study will look at the safety, tolerability and effectiveness of cidofovir in kidney     transplant patients who have been diagnosed with BK virus nephropathy (BKVN), a viral     condition that can cause patients to reject transplanted kidneys. Up to 48 adult (age 18     years and older) kidney or pancreas transplant recipients with newly diagnosed BKVN will     receive 1 of 3 cidofovir dose levels or placebo (non medicated substance) to identify the     maximum tolerated dose. Dosing will be administered intravenously (by a tube running into a     blood vessel). In addition to the screening visit, volunteers will actively participate for     approximately 8-10 weeks with a single follow up phone call at 4 months. Blood samples, urine     samples, eye exams and physical exams are included in study procedures.   "
175426|NCT00138437|"     The purpose of this study is to determine what factors contribute to the continued incidence     of leprosy in Colombia. Study participants will include volunteering and consenting     individuals, older than 4 years of age, representing three study groups:        1. healthy persons with no known contact with leprosy patients        2. patients reporting at Instituto Colombiano de Medicina Tropical-CES and Impresa Social          del Estado Sanatorio Agua de Dios with a new diagnosis of leprosy or relapse of leprosy        3. household contacts of leprosy patients described in group 2. Blood, nasal swabs, slit          skin smears, and biopsies will be taken from the volunteers to learn the strains of          leprosy-causing bacteria in the area, the immune responses (body's response to disease)          in local residents against the bacteria, and the pattern of leprosy transmission.          Individuals will participate in this study for 1-10 days, and the study will last for 3          years.   "
175427|NCT00138450|"     The purpose of this study is to determine what causes some people to become sick, and others     not, when they are infected with the parasite Schistosoma haematobium, also known as     Bilharzia. This is an infection of the urinary tract blood vessels and can cause serious     disease. Approximately 4400 adults and children of any age will participate in this study.     They must be residents of the Msambweni Area, Kwale District, Coast Province, Kenya, where     infection with S. haematobium parasites are common. To find out if people are infected, they     will first provide 1 or more urine samples for a microscope examination to detect if the S.     haematobium parasites are present in the body. Volunteers then will be examined by ultrasound     to see if they have kidney or bladder disease. (Ultrasound examination is the use of a     non-painful machine that uses sound waves to examine the condition of the internal organs.)     Treatment with the drug praziquantel will be offered if S. haematobium infection is found.   "
175428|NCT00138463|"     West Nile Virus causes an infection that is spread to humans when bitten by certain types of     mosquitoes. Mosquitoes become infected by biting infected birds. The purpose of this study is     to find out more about West Nile Virus, which may assist in the design of better treatments.     The study will be looking at the effects of the disease on individuals, specifically their     nervous systems, and the outcomes of the disease. Study participants will include 120 adults     ages 18 and older, who have either a fever and/or changes in their neurological (involving     the brain and nervous system) status due to documented West Nile Virus infection. Study     procedures will include physical examinations, blood tests, urine tests, cerebral spinal     fluid (fluid in and around the brain and spinal cord) tests, and neurological (nervous     system) testing. Study participants will be followed for 12 months.   "
175429|NCT00138476|"     The main objective of this study is to see the number of volunteers that get sick from a     Norwalk virus (NV) inoculation with typical symptoms of nausea, vomiting, and diarrhea. If     this NV preparation is shown to cause Norwalk illness, then it can be used to test new     vaccines in the future. Additionally, researchers hope to determine the lowest dose of NV     inoculum that can be given to volunteers and cause illness. Study participants will include     57 healthy adults, ages 18-50. Participants will either be given the NV inoculum or placebo     (water without virus). Participants will be hospitalized for a maximum of 7 days and a     minimum of 4 days following the NV challenge. Study procedures include physical exam, blood     testing, and collection of saliva, urine, and stool samples. Participants will be involved in     study related procedures for up to 180 days.   "
175430|NCT00138489|"     The purpose of this study is to learn more about vivax malaria in very young children, how     the growth of children is affected by malaria infections, and how inherited traits protect     children from getting malaria. Participants will be 266 children 24 months of age or younger     who live in certain villages in East Sepik Province, Papua New Guinea, where malaria is very     common. The study also will find out how malaria spreads in the area. By learning how and     when a child develops resistance to vivax malaria, researchers can try to find ways to help     people from getting it. And, they can get a better understanding of how inherited traits     influence all types of malaria infections. In this study, the parent and child will be     visited by the study team or health workers every week to check health and bednet use. Every     2 weeks, the study team will take a small blood sample to check for malaria and take     measurements to study the child's growth. Participants will be followed for up to 2 years.   "
175431|NCT00138502|"     The purpose of the study is to test the hypothesis that a subpopulation of patients with     candiduria are at significant risk for disseminated disease and would benefit from treatment,     while others are at low risk from complications and therefore require no antifungal therapy.   "
175432|NCT00138515|"     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a     single oral drug. This is a 28-week extension to a study to assess the safety and     effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels     when added to metformin in people with type 2 diabetes who are not at target blood glucose     levels on metformin alone. The purpose of the extension study is to gather data on the     long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.   "
175433|NCT00138528|"     Other effects of fluvastatin are investigated in German patients with metabolic syndrome.   "
175434|NCT00138541|"     This is a 28-week extension to a study of the safety and effectiveness of three doses of     vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose     levels in people with type 2 diabetes who have not been previously treated with drug therapy     to lower their blood sugar. The purpose of the extension study is to gather long-term safety     and efficacy data for vildagliptin in people with type 2 diabetes.   "
175626|NCT00141206|"     The primary purpose of this study is to evaluate the safety and efficacy of varenicline given     for a twelve week treatment period in comparison with placebo and Zyban for smoking     cessation.   "
175437|NCT00138580|"     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a     single oral drug. This is a 28-week extension to a study to assess the safety and     effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels     when added to glimepiride in people with type 2 diabetes not at target blood glucose levels     on a sulfonylurea alone. The purpose of the extension study is to gather data on the     long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.   "
175438|NCT00138593|"     This study is not being conducted in the United States. This is a 52-week extension to a     study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved     drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not     previously been treated with drug therapy to lower their blood sugar and whose blood sugar     levels were in a specified range. The purpose of the extension study is to gather data on the     long term safety and effectiveness of vildagliptin in people with type 2 diabetes.   "
175439|NCT00138606|"     Many people with type 2 diabetes cannot maintain their target blood glucose levels on a     single therapy. This is a 28-week extension to a study to assess the safety and effectiveness     of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to     insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin     alone. The purpose of the extension study is to gather data on the long-term safety and     effectiveness of vildagliptin in people with type 2 diabetes.   "
175440|NCT00138619|"     This is an 80-week extension to a study to assess the safety and effectiveness of     vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose     levels in people with type 2 diabetes who have not previously been treated with drug therapy     to lower their blood sugar. The purpose of the extension study is to gather data on the     long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.   "
175441|NCT00138632|"     This study evaluates the tolerability and safety of 3 months treatment with PTK787 tablets     given daily. It also explores the efficacy of the compound in patients with wet age-related     macular edema.      In Cohort 1 verteporfin/PDT is the active control. The protocol was amended to reflect the     current standard of care for AMD. As a result, ranibizumab is the active control for Cohort     2.   "
175566|NCT00139958|"     Objectives: Evaluate differences for mortality, morbidity and the cardiovascular risk factors     between HIV and non-HIV patients with an acute coronary syndromes (ACS) after a 3-years     follow up.   "
175442|NCT00138645|"     It is hypothesized that the use of a partial supplement diet, which includes the use of meal     replacements, will result in significantly greater weight loss after three and six months     compared to an isocaloric diet that does not include supplements. It is also hypothesized     that the partial supplement diet will result in larger improvements in body composition,     disease biomarkers, and health parameters (blood pressure, lipids) compared to the     non-supplement diet. Finally, it is hypothesized that subjective ratings of satiety will be     significantly higher, and ratings of hunger lower, in the group consuming a partial     supplement diet.   "
175443|NCT00138658|"     This clinical study will help determine if giving OGX-011 (custirsen sodium) in combination     with gemcitabine (GEM) and cisplatin (CIS) or carboplatin (CARB) is a safe and effective     treatment for patients with lung cancer. This study will help to assess the safety and     anti-tumor effect of OGX-011 when given to patients in combination with GEM and CIS/CARB.   "
175444|NCT00138671|"     A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics     with Chronic Obstructive Pulmonary Disease.   "
175445|NCT00138684|"     The aim of the study is to determine, in patients presenting hepatic iron overload (genetic     haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy     on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone     before and after venesection.   "
175446|NCT00138697|"     The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L,     were studied in patients with hypogammaglobulinemia, who are regularly treated with     intravenous immunoglobulin substitution therapy.   "
175447|NCT00138710|"     In this study, 50 obese men with a hormonal imbalance will be treated with letrozole or     placebo for six months in order to examine the effects on the hormonal balance, and on weight     loss. The study will also address the side effects and psychological effects of letrozole as     compared to placebo.   "
175448|NCT00138723|"     This Phase 3 trial will investigate the efficacy, tolerability and safety of fesoterodine     fumarate (SR) (fesoterodine; SPM 907) in adult male and female subjects with overactive     bladder syndrome. The trial is a randomized, double-blind placebo controlled multicenter     trial.      The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2     week Safety Follow-Up period. Subjects were randomized to one of 3 treatment arms receiving     either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, or placebo during the     double-blind Treatment period.      Two primary efficacy variables will be assessed for submission in the United States: change     in the average number of micturitions (frequency) per 24 hours and the change in the average     number of urge incontinence episodes per 24 hours. For the submissions in the European Union,     the first primary variable will be the change in the average number of micturitions     (frequency) per 24 hours and the co-primary variable is the treatment response, based on a     treatment benefit scale. All continuous variables will be measured as changes from baseline     to value after 12 weeks of treatment. The following safety variables were observed and     assessed: adverse events, change in residual urinary volume (mL), change in laboratory     parameters, change in vital signs, change in electrocardiogram (ECG), change in physical     examination and change in urological/urogynecological examination.   "
175449|NCT00138736|"     The pharmacokinetics, and clinical and biological effects of MBL replacement therapy in     MBL-deficient children during chemotherapy-induced neutropenia were studied.   "
175450|NCT00138749|"     A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of     stress urinary incontinence.   "
175451|NCT00138762|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or     placebo.   "
175452|NCT00138775|"     The goal of the present study is to evaluate the effect of D-serine, added to antipsychotic     treatment, on negative and cognitive symptoms in schizophrenia.      The investigators are hypothesizing that D-serine will improve cognitive functioning and     negative symptoms.   "
175453|NCT00138788|"     This is a comparison of radiotherapy fractionation schemes for brain metastasis.   "
175457|NCT00138840|"     STA-5326 is an experimental drug that has been shown to block the release of interleukin-12     from peripheral blood mononuclear cells. Given this activity on the immune system, STA-5326     mesylate is a potential treatment for various autoimmune diseases, such as Crohn's disease,     that are mediated by the inappropriate expression of Th1 cytokines.      This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe,     active Crohn's disease. Study visits include a screening visit, 9 treatment period visits     over 6 months and a follow-up visit that will occur 30 days following the end of treatment.     Study drug treatment will continue for up to 6 months.   "
175458|NCT00138853|"     The purpose of this study is to compare the early migration of two uncemented total knee     arthroplasties with different metal coating. Only the tibial prosthesis plateau varies. One     is made out of tantalum and has two short pegs for fixation into the tibia while the other is     covered by titanium fiber-mesh on the bone-near site and has 4 short pegs for screw fixation     into the tibia.   "
175459|NCT00138866|"     The purpose of this study is to find out if risedronate works for the treatment of     osteoporosis for people with spinal cord injury.   "
175471|NCT00139022|"     Obstructive Sleep Apnea (OSA) is a common and underrecognised condition. The diagnosis of OSA     is typically made after an in-lab polysomnography (PSG) which requires an overnight stay in a     sleep laboratory. Many sleep laboratories have long waiting lists for PSG. There are a number     of portable devices which may be useful in home diagnosis of OSA, however there is limited     data on outcomes of OSA diagnosed and treated at home. In this study we propose to compare     diagnostic accuracy of a home monitoring device with a PSG and outcomes of OSA therapy when     implemented at home vs in the sleep laboratory.   "
175472|NCT00139035|"     Our primary aim is to investigate if cyclosporine A reduces insulin secretion.   "
175523|NCT00131963|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. Giving chemotherapy after surgery may kill any tumor cells that remain     after surgery.      PURPOSE: This phase II trial is studying how well doxorubicin, cyclophosphamide, and/or     paclitaxel work in treating women with nonmetastatic breast cancer.   "
175460|NCT00138879|"     Citrulline is an amino acid produced in the intestine and in the liver, but the liver does     not contribute significantly to circulating citrulline concentrations. The intestine is thus     the only organ that normally releases significant amounts of citrulline into the blood. The     investigators have designed a study looking at the value of measuring plasma citrulline     concentration in patients with Crohn’s disease and short bowel or normal intestinal length.     Measuring the plasma citrulline concentration in short bowel patients may help to distinguish     between patients who need permanent parenteral feeding from patients with just transient     intestinal dysfunction. It may also help the investigators in understanding the small bowel     intestinal length remaining and the absorptive integrity. In patients with normal intestinal     length and Crohn’s disease, it may be a reliable marker of small bowel damage and could be     applied to establish therapeutic improvements. It has been demonstrated to strongly correlate     (inversely) with severity on intestinal biopsies.      The investigators hypothesise that the plasma citrulline concentration is a marker for small     bowel absorptive integrity and an appropriate surrogate for functional length of the small     intestine.      Controlled data do not yet exist to establish the place of plasma citrulline in the     assessment of small bowel function in man.   "
175461|NCT00138892|"     The primary research question is: Does expedited hip and knee replacement result in improved     lower-extremity function at 36 months post randomization as measured by the Western Ontario     McMaster Universities Osteoarthritis Index (WOMAC)? A secondary component to this question is     whether expedited surgery improves pain and stiffness scores as measured by the WOMAC and     generic QOL as measured by the Medical Outcomes Study Short-Form 36 (SF-36) and Health     Utilities Index Mark 3 (HUI3)? Secondary questions are: Does joint-specific and generic QOL     deteriorate significantly during waiting? Does prolonged waiting increase the economic cost     associated with hip and knee arthroplasty? And does expedited surgery have an effect on     patient satisfaction with major joint replacement?   "
175462|NCT00138905|"     The purpose of this study, is to investigate if low intensity electromagnetic radiation, can     influence the cognitive performances and well being of healthy adolescents and adults.     Furthermore, the purpose is to provide any special information about the subjects which can     cause the possible reactions. Finally, the investigation will try to clarify if there is     anything specific in the radiation signal that causes the effect   "
175463|NCT00138918|"     The purpose of this trial is to assess the effects of combined therapy with androgen ablation     and OGX-011 (an antisense to clusterin) given prior to radical prostatectomy on pathologic     complete response rates in men with localized prostate cancer and high risk features.   "
175464|NCT00138931|"     We are studying the genetics of human cardiovascular and neuromuscular disease. There are     many different genetic regions that have been associated with the development of     cardiomyopathy. An equal number of genetic regions have been associated with muscular     dystrophy and there is overlap because some of the identical genes, when mutated, produce     both cardiomyopathy and muscular dystrophy. We are working to identify genes and gene     mutations associated with cardiomyopathy, arrhythmias and muscular dystrophy. We propose to     screen these samples for mutations in genes known to be involved in these disorders.   "
175465|NCT00138944|"     Resistant hypertension is defined as hypertension not controlled (i.e. blood pressure not     below 140/90 mmHg) with the use of adequate doses of at least three different     anti-hypertensives including a diuretic. Resistant hypertension is abundant. In the ALLHAT     trial 34% of patients did not reach the blood pressure goal of 140/90 mmHg. One possible     mechanism of resistance is the aldosterone-escape phenomenon.      During aldosterone escape, aldosterone plasma levels are normal or even elevated despite     therapy with ACEIs or ARBs. The prevalence is about 30-50%. Possible reasons for aldosterone     escape are alternative ways of aldosterone stimulation (hyperkalemia, adrenomedullin, ACTH),     local aldosterone production or primary aldosteronism. Aldosterone has deleterious blood     pressure independent effects on cardiac, vascular and renal damage.      Hypothesis: Eplerenone is effective to improve hypertensive target organ damage in patients     with resistant hypertension.   "
175466|NCT00138957|"     The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia     repair using an intraperitoneally placed Proceed mesh, looking at postoperative     complications, recurrence rate and postoperative pain and quality of life.   "
175467|NCT00138970|"     To compare renal function (51Cr-EDTA clearance) 12 months posttransplant, in primary renal     allograft recipients (from cadaveric donor) at low immunogenic risk, 0 DR mis-match,     receiving immunosuppressive therapy with A) Zenapax® (5 doses), CellCept® (1.5 g bid., aiming     for TDM for total trough concentrations of 2-6 mg/L) and prednisolone or B) Sandimmun Neoral®     (full dose), CellCept® (1.0 g bid.) and prednisolone.   "
175468|NCT00138983|"     The purpose of this study is to determine wich treatment is the most effective in prevention     of glucocorticoid-induced osteoporosis in patients with rheumatic diseases. The STOP-study: a     randomized placebo controlled trial with alendronate versus alfacalcidol.   "
175594|NCT00140790|"     The purpose of this study is to investigate if an angiotensin II receptor blocker, valsartan     160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to     40 mg/day in patients with moderate renal dysfunction.   "
175469|NCT00138996|"     Quality of bystander cardiopulmonary resuscitation (CPR) affect patient survival. Quality of     professional CPR on patients has not been studied in detail, but it is regularly reported     that the quality when tested on manikins deteriorates dramatically within months after     training. Automated direct feedback on CPR quality from manikins brings quality back within a     couple of minutes. Similar feedback has been incorporated into a defibrillator which also     monitors quality of CPR. We hypothesise that quality of professional clinical CPR improves     with such feedback   "
175470|NCT00139009|"     The primary objective is to investigate intralymphocyte concentrations of CsA in renal and     heart transplant recipients to elucidate the association between the intracellular     concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA     based immunosuppressive therapy.   "
175487|NCT00139230|"     The purpose of this study is to further test a combination chemotherapy regimen for the     treatment of squamous cell carcinoma of the head and neck and to see if the addition of     supportive medicine can help reduce the side effects of these drugs.   "
177261|NCT00160719|"     The purpose of this study is to find out whether or not antibodies to the donor bone are     present in the blood of patients who receive the donor bone.   "
175473|NCT00139048|"     Women who access the website, are aged between 38-45 years and are considering screening     mammograms will be randomized to either the Decision Aid (a booklet providing information and     exercises to help them to make a decision about whether to having screening mammograms) group     or the Control Group. The Decision Aid group will first read the decision aid, and then will     be asked some demographic and knowledge questions. The control group will be asked the     demographic and knowledge questions only. The control group will have access to the Decision     Aid after they have completed the questions   "
175474|NCT00139061|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      To assess the HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs.     fenofibrate.   "
175475|NCT00139074|"     The primary purpose is to investigate whether the addition of sodium valproate will be     superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14     days in non-responding patients after a 14 day initial treatment period with quetiapine.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
175476|NCT00139087|"     The Telephone Outreach for Therapy Trial was designed to test an intervention to assist new     mothers or caregivers of HIV-exposed children with administering medication for the first 6     weeks of life to prevent mother-to-child HIV infection in the infants. To be eligible,     mothers of infants were identified as HIV-infected in the Mother-Infant Rapid Intervention at     Delivery Study. Mothers or caregivers of infants were randomized into two groups: the     intervention group received a cellular phone and scheduled twice daily calls to assure infant     medications were given, and the other group received the current standard of care. Enrollment     into the study was completed and analysis of the study data is underway.   "
175477|NCT00139100|"     Introduction. Lymphatic filariasis is a devastating mosquito-transmitted parasitic disease     that causes lymphedema or elephantiasis of the leg in 15 million persons, the majority of     whom are women. In these persons, frequent bacterial infections (acute attacks) of the legs     adversely affect physical health, economic well-being, and quality of life. Prevention of     bacterial infections through hygiene and skin care can result in significant improvements in     lymphedema and patient well-being.      Methods. To determine the extent to which antibacterial soap can help reduce the incidence of     acute bacterial infections of the lower limbs in persons with filarial lymphedema, 200     patients of the Ste. Croix Hospital lymphedema treatment clinic in Leogane, Haiti randomly     assigned to receive either antibacterial (Safeguard) or placebo (Camay) soap and acute     attacks monitored monthly for 12 months. Both groups received specific instructions on     washing and skin care.   "
175478|NCT00139113|"     Infants born to immune mothers and therefore having passively-transferred maternal antibody     (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We     compared the immunogenicity of hepatitis A vaccine among infants with and without PMA,     vaccinated on different schedules. We found that when vaccination is begun at or after 12     months of age, there was no difference in the immune response to the vaccine between infants     born to immune vs. susceptible mothers.   "
175479|NCT00139126|"     The purpose of this study to evaluate whether (1) targeted smoke alarm education, (2) general     fire safety education with a smoke alarm component, (3) basic fire safety education, or (4)     an unrelated intervention is most effective way to improve smoke alarm maintenance and     function.   "
175480|NCT00139139|"     Immune globulin is effective about 85% of the time in preventing hepatitis A in people who     have been exposed, if it is given within 14 days of exposure. Several lines of evidence     suggest that hepatitis A vaccine might also be effective in this setting, and vaccine has the     advantage of providing long term protection. In this study, we compare how well immune     globulin and hepatitis A vaccine work in preventing clinical hepatitis A in household     contacts of persons with the disease. The study's hypothesis is that the the proportion of     exposed household contacts who receive hepatitis A vaccine within 14 days of exposure and     develop hepatitis A disease will be similar to the proportion of exposure household contacts     who receive immune globulin within 14 days of exposure and develop hepatitis A disease.   "
175481|NCT00139152|"     The purpose of this study is to study the effects of Xolair using non-invasive techniques     from the expired gas of patients with moderate to severe allergic asthma.   "
175482|NCT00139165|"     The aim of the trial is to examine the effect of budesonide treatment on collagenous colitis.     All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks     treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms     (number of daily stools)   "
175615|NCT00141063|"     The purpose of this study is to compare the safety and efficacy of two doses of     dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD     (MPH) and placebo in children ages 6-12 diagnosed with ADHD.   "
175483|NCT00139178|"     Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV     infected individuals. However an increasing number of HIV-patients have developed metabolic     and morphological alterations including peripheral lipoatrophy.      The main hypothesis of the study is that switching from thymidine-analogue based HAART will     reverse lipoatrophy.      We plan to perform an observational study recruiting up to 100 HIV-infected patients     receiving Trizivir (zidovudine/lamivudine/abacavir).      The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can     choose to continue with Trizivir.      The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.   "
175484|NCT00139191|"     The purpose of this study is to understand if a new type of radiology test called positron     emission tomography (PET) with carbon 11 acetate will help us to understand which cancers     produce more of a protein called fatty acid synthase (FAS).   "
175485|NCT00139204|"     The purpose of this study is to better understand a new type of radiology test called     positron emission tomography (PET) with carbon 11 methionine to determine which patients have     a beneficial effect from anti-cancer therapy with the drug docetaxel.   "
175486|NCT00139217|"     The primary objective of the trial is to determine the feasibility and clinical safety and     efficacy of non-invasive inhaled nitric oxide in infants with PPHN without significant     pulmonary +-parenchymal disease who would normally receive inhaled nitric oxide only after     placement of a tracheal tube and the institution of mechanical ventilation.   "
175489|NCT00139256|"     This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone     versus a placebo given prior to the mothers at term and near term gestation (>34 and <40     weeks of gestation) who are scheduled to undergo a planned Cesarean section. The study design     is to determine the efficacy and safety of betamethasone in the prevention of breathing     problems commonly seen in this population.      In infants born by elective Cesarean section, it is hypothesized that antenatal betamethasone     treatment will reduce the risk of neonatal intensive care unit (NICU) admission from 11% to     8% and/or oxygen therapy +/- positive pressure ventilation (PPV) for >30 minutes from 4.5% to     2.5%.   "
175490|NCT00139269|"     The purpose of this study is to determine the appropriate dose, that dose which is found to     give maximum effect with limited toxicity, of cisplatin in combination with docetaxel and     5-fluorouracil and then to further define the safety and effectiveness of this combination of     medications.   "
175491|NCT00139282|"     Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that     causes a progressive loss of central vision. AMD is the leading cause of blindness among     adults age 50 or older in the Western world. AMD presents in two different types: dry and     the more severe wet form. Wet AMD is caused by the growth of abnormal blood vessels in the     macula. Squalamine lactate is an investigational drug that may prevent the growth of these     abnormal blood vessels. This study will evaluate the safety and efficacy of Squalamine     lactate in the treatment of AMD in patients, the exact number of which will be determined     based on data from the sponsor's ongoing Phase 2 trials.      The trial objective is to evaluate the safety and efficacy of two doses of Squalamine lactate     for Injection administered as intravenous infusions weekly for 4 weeks followed by     maintenance doses every 4 weeks through week 104 compared with the safety and efficacy in the     control group.   "
175492|NCT00139295|"     This is a clinical study to investigate the safety and efficacy of hylastan in treating     patients with symptomatic osteoarthritis (OA) of the knee.   "
175493|NCT00139308|"     Tourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial     consequences in some patients. The pathophysiology is still unknown. Some data suggest an     dysfunction of limbic circuits in basal ganglia. The aim of this study is to evaluate the     effect of high frequency stimulation of the internal part of the globus pallidus and/or     parafascicular-median centre of the thalamus, two structures implicated in the limbic     circuit, in patients with severe Tourette's syndrome.   "
175494|NCT00139321|"     Gait disorders and falls are frequent in patients with parkinsonian syndromes. In patients     with Parkinson's disease (PD), these signs occurred later during the course of the disease in     comparison to patients with other degenerative parkinsonian disorders. The pathophysiology of     these symptoms are still not fully understood. Gait initiation challenges the balance control     system as the body moves from an upright stable static posture to a continuously unstable     gait. The aim of this study is to analyse the gait initiation process in patients with     parkinsonian disorders.   "
175495|NCT00139334|"     The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV     vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days     after the OPV dose).   "
175496|NCT00139347|"     The main objectives of this study is to determine vaccine efficacy against severe rotavirus     (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year     of age.   "
175497|NCT00139360|"     To determine the efficacy as measured by objective tumor response of first-line treatment of     metastatic melanoma with bevacizumab monotherapy   "
175498|NCT00139373|"     The syndrome of distractibility is a behavioral disorder induced by a lesion or a dysfunction     of the frontal lobe. This sign is frequent in patients with progressive supranuclear palsy     (PSP), a neurodegenerative disorder with severe neuronal loss in the prefrontal cortex and     cholinergic systems, in particular in the Meynert basalis nucleus. This could participate in     the occurrence of the distractibility in these patients. The aim of this study is to evaluate     the effect of the donepezil, an anticholinesterase, on the distractibility in PSP patients,     by using oculomotor and neuropsychological assessments.   "
175616|NCT00141076|"     This study will compare the physiological effects of two isoenergetic, nutrient-controlled     diets that differ in glycemic index. The diets will be studied in obese adults in a 10-day     crossover feeding trial.   "
175499|NCT00139386|"     Candesartan is effective in preventing cardiovascular events in patients without restenosis     after coronary angioplasty. Therefore, the investigators hypothesized that candesartan after     drug-eluting stent (DES) implantation was also effective in preventing cardiovascular events.      The purpose of this study is to investigate whether an angiotensin II receptor blocker,     candesartan, is effective in reducing the incidence of cardiovascular events after     drug-eluting stent implantation.   "
175500|NCT00139399|"     The purpose of this study is to determine whether the radial artery (artery in the arm) or     saphenous vein (vein in the leg), when used as bypass grafts for coronary artery bypass     surgery, have a greater patency rate (degree of opening)at 5 years after surgery.   "
175501|NCT00139425|"     The purpose of this study is to assess the impact of disease management interventions on bone     mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years     or older.   "
175502|NCT00139438|"     The purpose of this study is to assess the impact of disease management interventions on     percent receiving a bone densitometry test and percent appropriately prescribed a medication     for osteoporosis.   "
175503|NCT00139451|"     The purpose of the study is to find out if patients with constitutional delay of growth have     a mismatch between energy intake and utilization (as measured by doubly labeled water) and to     compare the improvement in growth and energy balance between a group of boys treated with     growth hormone (GH) alone versus those given GH plus added nutritional supplements for one     year.   "
175524|NCT00131989|"     This phase I trial is studying the side effects and best dose of sorafenib in treating     patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, or     chronic myelogenous leukemia. Sorafenib may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth and by blocking blood flow to the cancer   "
175567|NCT00139971|"     To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative     adjuvant chemotherapy for completely resected non-small cell lung cancer.   "
175504|NCT00139477|"     In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an     abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal     to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in     Protocol #1). They will be randomly assigned to either lifestyle intervention (diet/exercise)     or diet/exercise plus metformin for 6 months. After the 6 month evaluation the subjects will     cross over the treatment arms, i.e., those that were doing diet/exercise intervention only     will add metformin, those that were doing the diet/exercise plus metformin will discontinue     the metformin and continue with diet/exercise changes only. Intrahepatic fat contents will be     measured as well.      The investigators hypothesize that obese children in these age groups will have increased     cardiovascular risk related to their obese state before reaching the currently defined     criteria of metabolic syndrome.      The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle     and drug interventions.   "
175505|NCT00139490|"     The purpose of this study is to examine the effectiveness and cost effectiveness of two     organizational interventions aimed at improving blood pressure (BP) control among a     high-risk, African American home care population.   "
175506|NCT00139516|"     The study has two objectives/aims:      Aim 1: To test the efficacy of the intervention among adult smokers with cardiovascular     disease, pulmonary disease and diabetes mellitus related illnesses (later modified to Chinese     adults with and without diseases); and      Aim 2: To examine a set of measures (background, general health, psychosocial, and smoking     process) that are associated with smoking cessation at 6 and 12 months   "
175507|NCT00139529|"     The purpose of this study is to develop and field test a maintenance of smoking abstinence     program designed for a predominately low-income, high-risk population of women from a wide     variety of ethnic and racial backgrounds who have quit smoking because of (or during) their     pregnancy.   "
175508|NCT00139542|"     The aim of the trial is to evaluate a new AED algorithm that proposes a new timeline between     the time devoted to administer a defibrillation shock, and the time devoted to chest     compressions.      The researchers propose to decrease the periods of interruption of cardiopulmonary     resuscitation (CPR), while keeping the principle of early defibrillation.   "
175509|NCT00139555|"     Left ventricular hypertrophy (LVH) increases the risk of cardiovascular morbidity and     mortality in patients with high blood pressure, compared to those without LVH. Reduction of     left ventricular mass (LVM) with antihypertensive agents is associated with improved clinical     outcome. This study will evaluate the effects of amlodipine/benazepril in reducing LVM in     patients with high risk hypertension.   "
175510|NCT00139568|"     Tegaserod is an aminoguanidine indole compound and a member of a new class of     5-hydroxytryptamine (5-HT) agonists. Activation of 5-HT4 receptors triggers the release of     neurotransmitters from the enteric nerves which in turn stimulate contractility and     peristalsis. This study will investigate the efficacy and safety of tegaserod against chronic     constipation in a Chinese population of adult men and women   "
175511|NCT00139581|"     This study is not being conducted in the United States.      To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.)     versus once daily (o.d.) in preventing the progression to disease relapse.   "
175512|NCT00139594|"     This extension study is designed to assess the long-tem tolerability and safety of     licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.   "
175513|NCT00139607|"     This is a phase III, multicenter, open label, pilot to evaluate the analgesic efficacy and     safety of parecoxib 40 mg IV in the treatment of the pain following hemicolectomy in an     optimal management of the surgical patient   "
175514|NCT00139620|"     This is a multicenter, open-label, 2-arm study comparing erlotinib exposure in cancer     patients with adequate hepatic function versus cancer patients with moderate hepatic     impairment. All patients will receive a single 150 mg dose of erlotinib on Day 1 followed by     96 hours of plasma sampling for PK and protein binding studies. Patients may then enter the     maintenance phase of the study and continue to receive erlotinib until disease progression or     unacceptable toxicity.   "
175515|NCT00139633|"     This prospective study was designed to assess the outcomes (survival and failure patterns) of     therapy for localized esophageal cancer with conventional dose radiation (RT; 50.4 Gy) with     concurrent continuous infusion 5-fluorouracil (5-FU) and weekly carboplatin/paclitaxel.     Patients with less than complete response (CR) or partial response (PR) received dose     escalation of radiation to 59.4 Gy with the same chemotherapy.   "
175516|NCT00139646|"     This is a phase III, multicenter, randomized, single blind study designed to evaluate the     efficacy and tolerability of a single dose of parecoxib compared with diclofenac in the     treatment of acute pain due to renal colic.   "
175517|NCT00139659|"     A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics     with Asthma   "
175519|NCT00139685|"     To evaluate and compare Bone Mineral Density (BMD) in adolescent Depo-Provera Contraceptive     Injection (DP150CI) users during depo medroxyprogesterone acetate (DMPA) therapy and     following discontinuation of DMPA. Another group electing non-hormonal contraception or     abstinence will be recruited as a reference population, across all study sites. The primary     variable is BMD, measured by Dual Energy X-ray Absorptiometry (DXA). Secondary variables are:     Total Body Composition& Total Body Calcium (TBC), measured by Dual Energy X-ray     Absorptiometry (DXA), and surrogate biologic BMD markers. Safety will be evaluated by adverse     event reporting, laboratory evaluations, pregnancies, weight and vital signs.   "
175520|NCT00139698|"     Efficacy, tolerability and safety of olmesartan alone or in combination with     hydrochlorothiazide in the treatment of mild to moderate essential hypertension   "
175521|NCT00139711|"     A multicenter randomized phase II study evaluating the activity and tolerability of three     different combinations of docetaxel (taxotere) and irinotecan (campto) as second line therapy     for recurrent or metastatic non small cell lung cancer (NSCLC)   "
175522|NCT00139724|"     To evaluate efficacy of tolterodine extended release formulation compared with immediate     release formulation in subjects with symptoms of overactive bladder   "
175568|NCT00139984|"     The purpose of this study is to determine whether in patients with arterial hypertension,     treatment guidance using 24-hour blood pressure measurement results in better blood pressure     control compared to treatment guidance using office blood pressure measurement.   "
175525|NCT00132002|"     This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating     patients with progressive stage IV breast cancer. Drugs used in chemotherapy, such as     suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic     acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth   "
175526|NCT00132015|"     RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin     (17-AAG), work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well 17-AAG works in treating patients with     systemic mastocytosis.   "
175527|NCT00132028|"     This phase II trial is studying how well vorinostat works in treating patients with relapsed     or refractory advanced Hodgkin's lymphoma. Vorinostat may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth.   "
175528|NCT00132041|"     RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor     cells. CT-, MRI-, or ultrasound-guided radiofrequency ablation may be an effective treatment     for liver cancer and cirrhosis.      PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating     patients with liver cancer and cirrhosis.   "
175529|NCT00132054|"     RATIONALE: Drugs used in chemotherapy, such as amrubicin and irinotecan, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of amrubicin when     given together with irinotecan in treating patients with recurrent or relapsed extensive     stage small cell lung cancer.   "
175530|NCT00132067|"     This phase II trial is studying how well vorinostat works in treating patients with recurrent     or persistent ovarian epithelial or primary peritoneal cavity cancer. Drugs used in     chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Vorinostat may also stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
175531|NCT00132080|"     The primary endpoint is coronary artery diameter, normalized for body surface area, 5 weeks     after randomization. Secondary endpoints include duration of fever, CRP levels, and adverse     events.   "
175532|NCT00132093|"     The purpose of this study is to ascertain whether treatment with the drug eplerenone, taken     early after a heart attack, prevents or reduces some of the adverse changes that may     otherwise naturally occur within the heart muscle, that lead ultimately to weakening of the     heart muscle and premature death.   "
175533|NCT00132106|"     The activity of the sympathetic nervous system seems to influence the uptake (and handling)     of glucose by the skeletal muscle of the forearm. Conditions in which sympathetic activity is     increased seem to inhibit/reduce forearm glucose uptake. Inversely a decrease in sympathetic     activity seems to increase glucose uptake. This study analyzes the effect of alfa-adrenergic     receptor blockade (counteracting sympathetic influence) on insulin-stimulated forearm glucose     uptake in patients with increased sympathetic activity (patients with chronic heart failure).   "
175534|NCT00132119|"     The purpose of this study is to determine if nalmefene is safe and effective in the treatment     of pathological gambling.   "
175535|NCT00132132|"     This study will evaluate the impact a behavioral intervention can have on BMI. The     researchers anticipate the intervention group will experience a decrease in BMI of     approximately five points. The intervention group will be compared to a control group. This     is a long term, randomized, controlled study. The behavioral intervention is conducted during     a four hour monthly session. The behavioral intervention includes: exercise, education on     medical aspects and nutrition, and empowerment.   "
175617|NCT00141089|"     Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of     subgroup-selective 5-hydroxytryptamine (5-HT) agonists.      The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in     male patients with chronic constipation.   "
184305|NCT00254774|"     The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate     during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid     Cycling.   "
175536|NCT00132145|"     Vascular diseases (cardiac events, strokes, peripheral vascular disease) remain the number     one killer in Canadian society as well as the leading cause of hospitalization and days spent     in the hospital. A 1996 estimate placed Ontario's vascular disease financial burden at $5.5     billion in total. Any intervention which lowers vascular risk, will have a direct impact on     the quantity and quality of life and costs of health care. Further integration of health     professionals in teams focused on chronic disease management in individuals and populations     is also ripe for further evaluation. Increased collaboration between family physicians,     physician specialists, nurse practitioners, and pharmacists are generally thought to be     beneficial for patient outcomes, but the literature is inconclusive and their     cost-effectiveness is unproven. In addition, combining centralized electronic up-to-date     information on the patient's status with evidence-based recommendations and the ability to     communicate either electronically or by phone is expected to result in improved access to     care, quality of care, continuity of care and increase cost-effectiveness of chronic disease     management.      COMPETE III builds on the researchers' previous work to study an electronic vascular tracking     and decision support system shared by patients and their physicians, combined with a clinical     care coordinator and automated telephone support system. The researchers are evaluating its     impact on vascular risk processes and outcomes, perceived usefulness, ease of use, need for     improvement, medication adherence, quality of life and patient goals and motivation.      Study hypothesis: Patients at increased risk of vascular events, if connected with their     family physicians, medical specialists and care coordinator via an electronic network (Web,     fax and telephone) sharing an intensive tracking, advice and support program, will lower     their vascular risk more than those in usual care.   "
175537|NCT00132158|"     The purpose of this Phase I study is to find the largest dose of the drug irinotecan, in     combination with ZD1839, that can be given safely to children and to learn the good and bad     effects. Studies performed in the laboratory have shown that ZD1839 helps make available the     orally administered irinotecan. In this study the intravenous (given into the vein) formula     of irinotecan will be given orally on days 1-5 and days 8-12. The dose of ZD1839 will be a     fixed dose and will be administered orally on days 1-12. Each course of treatment will     consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of     course 2 will be an intravenous administration. All other doses and subsequent courses will     consist of an orally administered dose.   "
175569|NCT00139997|"     The purpose is to study treatments of Seasonal Affective Disorder (SAD).   "
184476|NCT00257686|"     The purpose of this study is to compare the efficacy and safety of pitavastatin with that of     pravastatin in elderly patients   "
175542|NCT00132223|"     Angiographies of the supra-aortic vessels by magnetic imaging have become common recently. So     it was the purpose of this study to evaluate the imaging potential of different contrast     agents.      Three contrast agents for magnetic resonance imaging are compared in angiographies of the     supra-aortic arteries in a intraindividual study of 10 patients.      All applications of these contrast agents are performed with a flow of 2 ml/s. One contrast     medium is applicated a second time with a reduced flow of 1 ml/s.      The angiographies of the supra-aortic vessels are evaluated by two experienced readers in a     consensus reading. The signal/noise- and contrast/noise-ratio of anatomic vessel segments of     the carotic and vertebral arteries are measured and compared to each other.   "
175543|NCT00132236|"     This is a smoking cessation study with COPD patients where the researchers wanted to evaluate     if nicotine sublingual tablets or placebo combined with low or high individual support could     increase ½ and 1 year quit rates.   "
175544|NCT00132249|"     The Vietnam Head Injury Study (VHIS)-Phase III is a prospective, long-term follow-up study of     head-injured Vietnam veterans. The purpose of this research study is to determine the     long-term consequences, if any, of head injury.   "
175545|NCT00132262|"     The purpose of this study is to evaluate the effectiveness and ethnic differences of a brief     alcohol intervention for injured patients.   "
175546|NCT00132275|"     Viral upper respiratory infections occur frequently during childhood (6-8 per year) and are,     for the most part, self-limited episodes that resolve spontaneously and do not require     antibiotic therapy. Acute otitis media and acute bacterial sinusitis are frequent     complications of viral upper respiratory infections that will benefit from treatment with     antibiotics. Acute bacterial sinusitis is one of the most common diagnoses in ambulatory     practice and, in all age groups, accounts for an estimated 25 million physician office visits     annually. It is essential to distinguish between patients who are experiencing uncomplicated     viral upper respiratory infections and acute bacterial sinusitis to avoid the excessive use     of antibiotics for patients who will not benefit from them. This is especially important now     because of the escalation of antibiotic resistance among the bacteria that commonly cause     acute bacterial sinusitis, acute otitis media and pneumonia. Inappropriate use of antibiotics     is a major contributor to the problem of antimicrobial resistance - a problem which     dramatically increases both the cost and complexity of treatment.      To improve the diagnosis and treatment of patients with acute bacterial sinusitis and reduce     the inappropriate use of antibiotics, clinical guidelines have been developed by three     national organizations: the American Academy of Pediatrics, the Sinus and Allergy Health     Partnership and the Centers for Disease Control and Prevention. Traditionally, the diagnosis     of acute bacterial sinusitis is suspected on the basis of clinical signs and symptoms and is     confirmed with the performance of images (either plain radiographs, computed tomography or     magnetic resonance imaging). All three guidelines recommend that the diagnosis and treatment     of acute bacterial sinusitis should be based on clinical criteria alone without the     confirmation of imaging or other laboratory data. Although the similarity between the     different guidelines suggests that there is widespread consensus to use clinical criteria to     diagnose acute bacterial sinusitis, there is virtually no evidence to support this position.     Specific Aim 1 of this project is to evaluate the use of clinical criteria, without the     performance of images, as the basis for the diagnosis of acute bacterial sinusitis. A     randomized, placebo-controlled study design will be used to determine if the clinical     criteria proposed by the different guidelines can be used to identify children with upper     respiratory symptoms who will respond to antibiotic therapy. It is expected that children     with acute bacterial sinusitis who receive an antimicrobial will recover more quickly and     more often than children who receive placebo.   "
175547|NCT00132288|"     This is a study of whether physical activity of older adults can be improved by linking     primary care clinics serving older adults to a community-based program that provides     motivational support, including peer counselors, for engaging in and maintaining moderate     levels of physical activity.      Health care providers at the participating study sites routinely assess and track diabetic     patients' physical activity. In addition to this routine care, study volunteers are referred     to a support program that has been modelled on the Active Choices Program. Changes in     volunteers' levels of activity are measured at 3, 6, and 12 months.   "
175618|NCT00141102|"     To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole     in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in     high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.   "
175548|NCT00132301|"     VA Cooperative Study #553 is designed to prospectively evaluate the efficacy of early     adjuvant chemotherapy using docetaxel and prednisone added to the standard of care for     patients who are potentially cured by radical prostatectomy but who are at high risk for     relapse. The standard of care is surveillance, with the addition of androgen deprivation at     the time of biochemical relapse. This study will assess the effect of adding early     chemotherapy to the standard of care on progression free survival in Veterans at high risk     for progression after prostatectomy.   "
175549|NCT00139737|"     To provide treatment to eligible subjects who have successfully completed one of the     following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or     A1281088 (NCT00143351).   "
175550|NCT00139750|"     The purpose of the study is to examine the safety and efficacy and dose-response relationship     of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation;     including post-treatment follow-up of smoking status to one year from randomization. A small     satellite protocol (A3051048) investigated safety of a second course of therapy in subjects     who did not quit.   "
175551|NCT00139763|"     This is a questionnaire based study (no study drug is involved) that asks if more patients     with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next treatment     choice if inhaled insulin were available in addition to all currently available treatments,     compared with if inhaled insulin was not available as part of currently available treatments.      This study will also ask if patients with uncontrolled type 2 diabetes currently managed on     diabetes pills + once daily insulin will choose as the next treatment choice to take insulin     multiple times a day if inhaled insulin were available in addition to all currently available     treatments, compared with if inhaled insulin was not available as part of currently available     treatments.   "
175552|NCT00139776|"     To determine whether continuous use of celecoxib over a 6-month period is more efficacious     than usual or intermittent use in preventing spontaneous osteoarthritis flares of the knee     and hip.   "
175553|NCT00139789|"     This was a multicenter, open-label, randomized, crossover trial in subjects with MS who were     already taking a stable dose of baclofen (up to 80 mg/day) for spasticity. The trial was     designed to assess subject preference for Kemstro or conventional baclofen. At Visit 1,     subjects were screened, and if qualified, were randomly assigned to one of two following     treatment sequences: Kemstro/conventional baclofen or conventional baclofen/Kemstro.   "
175554|NCT00139802|"     The purpose of the study was to evaluate procedural and late outcome of coronary artery     stenting using 2 different unmounted stents   "
175584|NCT00140647|"     The purpose of this study is to determine if ramipril and/or rosiglitazone retard the     progression of atherosclerosis as evaluated by serial carotid intermedial thickness     measurements.   "
175555|NCT00139815|"     Study Objectives      PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior     to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in     the acute treatment of patients with unstable angina/non ST-segment elevation myocardial     infarction concurrently managed with standard medical therapy.      SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical     analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated     statistically.        -  To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at          Day 9        -  To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding          events up to Day 9        -  To determine whether the relative effect on the primary end point of fondaparinux versus          enoxaparin is sustained at Day 14, Day 30, Day 90 and Day 180      Study Drug: Patients will be randomized to receive either:        -  Fondaparinux 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or        -  Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection      Duration of Therapy:        -  Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier)        -  Enoxaparin 1mg/kg b.i.d. x 2-8 days or until clinically stable.        -  Patients should receive an ASA and all other standard medical therapies.      Substudy:        -  A substudy comparing routine early coronary angiography immediately or as soon as          possible (but no later than 24 hours after randomization) and intervention versus          delayed (>48 hrs) coronary angiography and intervention.      Primary Outcome: The first occurence of any component of the following composite up to Day 9:        -  Death        -  Myocardial Infarction        -  Refractory Ischemia   "
175556|NCT00139828|"     In this postmarketing study, the safety of Nonafact® (human coagulation factor IX) is     evaluated in previous treated and untreated patients with severe, moderate or mild     haemophilia B.   "
175557|NCT00139841|"     SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of     Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent     Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab     (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every     21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive     disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6     cycles may receive an additional 2 cycles. Following the end of treatment, patients will be     followed for up to 2 years until disease progression or start of another anti-cancer therapy.   "
175558|NCT00139854|"     This was a multicenter, open-label, randomized crossover trial comparing two treatments,     Alprazolam ODT versus conventional alprazolam tablets, in subjects who were already taking     conventional immediate-release alprazolam tablets for anxiety. The trial included five study     visits (four periods of 7 3 -day duration): Screening (Visit 1), Treatment Period 1 (Visit     2), Treatment Period 2 (Visit 3), Final Visit (Visit 4), and Follow-up (Visit 5 [telephone     visit]). At Visit 1, following screening, eligible subjects continued to take their own     conventional alprazolam as prescribed by their physician. At Visit 2, eligible subjects were     randomized in approximately equal numbers to one of two treatment sequences: Alprazolam ODT/     conventional alprazolam or conventional alprazolam/ Alprazolam ODT. Subjects continued taking     alprazolam in accordance with the treatment sequence to which they were assigned, at the same     dose regimen as their own prescribed alprazolam. At Visit 3, subjects crossed over to the     alternate treatment until Visit 4. At Visit 4, subjects completed the Subject Preference     Questionnaire, and a physical examination and clinical laboratory tests were performed. At     the end of Visit 4, subjects resumed taking their own conventional alprazolam. The site made     a follow-up telephone call 7 - 3 days after Visit 4 to assess the subject's health status.   "
175559|NCT00139867|"     The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa     Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets,     in subjects with stable Parkinson's disease.   "
175619|NCT00141115|"     The purpose of this study is to determine if levetiracetam is effective in treating alcohol     dependence in patients with anxiety symptoms. The researchers hypothesize that individuals     are unable to reduce or discontinue alcohol use because of significant anxiety, mood, and     sleep disturbance symptoms that accompany reduction in alcohol use.   "
175620|NCT00141128|"     SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel     methodology   "
175560|NCT00139880|"     To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a     faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single     dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease.     Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are     eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both     treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or     conventional) are administered. The dose is the same as the subject's prestudy regimen. The     primary efficacy variable, time to onset of action, is the first postdose time when a 30%     decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by     a rater blinded to the active treatment received by the subject.   "
175561|NCT00139893|"     To determine whether a new Orally Disintegrating Tablet of Reglan (metoclopramide) is     metabolized faster than the conventional Reglan tablet in patients with diabetic     gastroparesis, pharmacokinetics following a single 10 mg dose of each formulation are being     compared. Subjects must be 18 or older, have Type 1 or 2 diabetes with documented     gastroparesis and agree to withhold medications for gastroparesis for 3 days prior to each     dosing. Exclusion criteria include serum glucose >300 mg/dL, Hb1Ac >10%, and concurrent     illness interfering with gastrointestinal motility. Subjects will stay in the clinic     overnight, and pharmacokinetic sampling will continue for 8 hours after the first morning     dose. The time (Tmax) and amount (Cmax) of peak concentration and the area under the curve     (AUC) from time zero to 8 hr will be compared for the 2 formulations.   "
175562|NCT00139906|"     This study is to assess the safety and tolerability of a five-day titration schedule (using     twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg     daily. The study duration is two months.   "
175563|NCT00139919|"     This study is to assess the tolerability of bifeprunox with the progressive elimination of     titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in     either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an     optional open-label 26-week extension study.   "
175564|NCT00139932|"     This study is being conducted to determine if the co-administration of formoterol fumarate     and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients     with COPD.   "
175565|NCT00139945|"     In growth hormone deficient patients: Determination of endogenous circulating ghrelin levels,     ghrelin effects on insulin sensitivity, appetite, energy metabolism, and signal transduction     in fat and muscle.   "
175570|NCT00140010|"     ABSTRACT:      Delayed ischemic deficits (DID) and strokes caused by low cerebral blood flow (CBF) are major     sources of poor outcome following aneurysmal subarachnoid hemorrhage (SAH). DID are often     accompanied by vasospasm and abnormalities in cerebrovascular autoregulation, an important     reflex involved in the defense against low CBF. Assessment of vasospasm and impaired     autoregulation can be conveniently measured non-invasively by use of transcranial Doppler     (TCD) and the transient hyperaemic response test (THRT). Vasospasm and abnormalities in the     THRT can predict those patients who are at risk of developing DID. In this study, the     investigators wish to explore the neuroprotective and angiogenic effects of systemic     erythropoietin (EPO) therapy on vasospasm and autoregulation following SAH, and examine     whether any improvements translate into reduced incidences of DID and poor outcome. Eighty     patients with SAH will be recruited over one year to receive three doses in the first week of     either intravenous epoetin beta 30000 IU or placebo (0.9% saline) 50 ml/30 min as part of a     randomized, double-blind, placebo-controlled trial. The investigators propose daily TCD     assessment for detecting vasospasm and abnormal autoregulation. Outcome measures will examine     the influence of EPO therapy on the incidence, severity, and duration of vasospasm, abnormal     autoregulation, and DID.      PURPOSE:      This study is a randomized, double-blind, placebo-controlled clinical trial investigating the     potentially beneficial effects of systemic recombinant human erythropoietin therapy (Epoetin     beta, NeoRecormon®, Roche, 30000IU/50 ml/30 min, three times in the first week) on cerebral     autoregulation and incidence of delayed ischemic deficits (DID) following aneurysmal     subarachnoid haemorrhage (SAH).      HYPOTHESIS Systemic recombinant human erythropoietin therapy can be used safely following SAH     to ameliorate vasospasm, improve cerebral autoregulation, reduce DID, and facilitate     neurological recovery.   "
175571|NCT00140023|"     The study will assess the clinical efficacy at Day 14-21 (Test of Cure), 14-21 days after     starting the study drug; those subjects from whom a baseline pathogen is identified will also     be assessed for bacteriologic response. All subjects who receive 1 dose of study medication     will be assessed for safety.   "
175572|NCT00140036|"     This protocol describes procedures for the collection of blood samples for the intent of     determining genetic contribution to the safety and efficacy of CPT/FU/LV.   "
175573|NCT00140049|"     To demonstrate the statistical non inferiority of the combination of latanoprost and timolol     given in the evening time once a day vs the combination of dorzamalide and timolol twice a     day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week     treatment.   "
175574|NCT00140062|"     The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with     that of usual care over 36 months. Safety and health care utilization will be evaluated.   "
175575|NCT00140530|"     The purpose of this study is to assess the efficacy of nonpolymer-based rapamycin-eluting     stent compared to standard polymer-based paclitaxel-eluting stent to reduce reblockage of     coronary arteries.   "
175576|NCT00140543|"     1. To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based          immunosuppression (in conjunction with initial short-term steroids and polyclonal          antibody administration) in Type 1-diabetic patients undergoing simultaneous          pancreas/kidney allograft transplantation.        2. To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related          complications and overimmunosuppression-associated complications, particularly under          monitoring of the pharmacokinetic profile of all drugs administered.   "
175621|NCT00141141|"     The purpose of this study is to evaluate the efficacy of Atorvastin vs Simvastatin in     decreasing LDL-C in diabetic subjects with hypercholesterolemia at the end of the treatment     phase.   "
175577|NCT00140556|"     Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative     intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia     and high levels of angiogenesis (blood vessel formation) are associated with treatment     failure. Preclinical models reveal that radiotherapy itself may induce tumor secretion of     vascular endothelial growth factor (VEGF). Curability may consequently be reduced by multiple     mechanisms. Over-expression of epidermal growth factor receptor (EGFR) also occurs commonly     and increases the risk of treatment failure. The addition of EGFR blockade to RT alone     increases the chance of a cure. Concurrent VEGF and EGFR blockade could be synergistic with     one another and improve the effectiveness of concurrent chemoradiation for advanced head and     neck cancer.      This study will add angiogenic and epidermal growth factor receptor (EGFR) blockade into an     established program of curative intent concurrent chemoradiation for locally advanced head     and neck cancer. The safety and effectiveness of delivering the drugs bevacizumab and Tarceva     in conjunction with twice daily irradiation and concurrent cisplatin (CDDP) chemotherapy will     be determined.   "
175578|NCT00140569|"     2 parallel studies.        -  For young patients (18-60 years): randomization between CHVP + interferon for 18 months          and 4 CHOP followed by autotransplant after TBI        -  For elderly patients (>60 years): randomization between CHVP + interferon for 18 months          and fludarabine 5 days every months for 6 months   "
175579|NCT00140582|"     -  Objectives             -  Primary objective: To evaluate in patients with advanced follicular lymphoma the               benefit of maintenance therapy with rituximab after induction of response with               chemotherapy plus rituximab in comparison with no maintenance therapy             -  Secondary objective: To evaluate response rates, event driven survival endpoints               (EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined               with rituximab, with or without maintenance with rituximab, for first line               treatment of advanced stage follicular lymphoma.        -  Study Design This is an international open-label, multicentre, randomized study with two          treatment phases. In the induction phase patients have to respond to 1st line induction          treatment in order to be eligible for randomization to the second phase of maintenance          treatment or observation. After the maintenance period patients will be included in the          follow up phase for 3 years.   "
175580|NCT00140595|"     This study is a multicentric randomized trial evaluating the efficacy of the combination     ACVBP+rituximab compared to the combination of CHOP+rituximab in patients aged from 18 to 59     years with diffuse large B-cell lymphoma and one factor of the age-adjusted international     prognostic index (IPI).   "
175581|NCT00140608|"     The purpose of this study is to investigate if the space occupying effect of Seprapack will     lead to a reduction in post operative adhesions and more healing of the sinus cavity when     compared to the use of no packing material.   "
175582|NCT00140621|"     This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and     safety of agalsidase beta (Fabrazyme [recombinant form]) administered by intravenous drip     infusion in participants with cardiac Fabry disease.      Participants participated for 4 weeks or less in the baseline period and 156 weeks for the     treatment period.   "
175583|NCT00140634|"     The objectives of the Cartilage Repair Registry is to report the long term efficacy and     safety of cartilage repair procedures in Registry patients.   "
175586|NCT00140673|"     The main objectives of this study are: 1) In a subset (N = 20 000), to determine vaccine     efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2     weeks after Dose 2 until one year of age. 2) In all subjects (N = 60 000), to determine the     safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within     31 days (Day 0-Day 30) after each HRV vaccine dose.   "
175587|NCT00140686|"     The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV)     gastroenteritis (GE) during the first efficacy period.   "
175588|NCT00140699|"     Balance disorders in children are poorly known, underestimated, and rarely assessed.     Technologies to assess balance in children are almost non-existent, apart from a few     exceptions. Such technologies are routinely used in adults for some decades, and are of     considerable contribution in the diagnosis and treatment of adults balance disorders.      The aim of this study is :        1. to assess objectively children balance disorders.        2. to provide technologies suitable for children balance assessement.        3. to study children balance disorders suffering from sensorineural hearing loss.   "
175589|NCT00140712|"     This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients     with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole     titration regimen for this age group. Patients will receive two single doses unless poor     tolerability is observed following the first dose.   "
175590|NCT00140725|"     This is a single-centre prospective randomised study comparing the virological and     histological response of HBV infection to lamivudine in combination with interferon versus     lamivudine alone.   "
175591|NCT00140738|"     Patients will receive a maximum of 18 injections of dHER2 vaccine in a treatment schedule     that will last for up to about a year, and thereafter there will be a follow-up period of     about one more year.   "
175592|NCT00140751|"     The purpose of this study is to compare the efficacy and tolerance of a treatment     simplification by a Lopinavir/ritonavir monotherapy versus continuation of current treatment     in HIV-infected patients   "
175593|NCT00140764|"     The purpose of this intervention is to find out whether intravaginal treatment with a gel     containing an antibiotic (metronidazole), compared to a similar placebo gel (without     antibiotic), can reduce the frequency of bacterial vaginosis, a common vaginal infection     among African women who are HIV uninfected or HIV infected. The study will also determine the     effect of these vaginal gels on genitourinary symptoms.   "
175622|NCT00141154|"     To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients     with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.   "
175595|NCT00140803|"     To determine whether VISUDYNE therapy in combination with 4 mg intravitreal triamcinolone     will reduce the average loss from baseline of best corrected visual acuity (BCVA) as compared     with Visudyne therapy without intravitreal triamcinolone at 12 months in subjects with occult     subfoveal and minimally classic subfoveal CNV secondary to AMD. The intravitreal     triamcinolone will be given as either a 1 mg or 4 mg dose. This study will also evaluate the     safety of Visudyne therapy in combination with intravitreal triamcinolone. An interim     statistical readout will be performed when the first 60 patients have completed 6 months of     follow-up evaluation.   "
175596|NCT00140816|"     Foods containing more dairy fat (and thus a higher proportion of short and medium chain fatty     acids and possibly some other nutrients or micronutrients with effect on energy intake,     satiety or energy metabolism) affect energy balance and metabolic profile in subjects prone     to develop abdominal adiposity and metabolic syndrome.      The aim of the study is to test the hypothesis that intake of dairy products has a favorable     effect on markers of the metabolic syndrome.      To explore such a hypothesis the participants have to be in a free living situation during an     extended study period.   "
175597|NCT00140829|"     Cerebellar ataxias (CA) and spastic paraplegias (SP) are genetically and clinically very     heterogeneous. More than 40 loci are already known but the number of phenotypes is even     greater suggesting further genetic heterogeneity. These progressive disorders are often     severe and fatal, due to the absence of specific therapy. The SPATAX network combines the     experience of European clinicians and scientists working on these groups of diseases. Over     the past year, they have assembled the largest collection of families and achieved a number     of tasks (initiation of a clinical and genetic database, distribution of DNA to participating     laboratories, mapping of three new loci, and refinement of several loci). In addition to     clinicians from Europe and Mediterranean countries, who play a major role in collecting     families according to evaluation tools developed and validated by the SPATAX members, the     group includes major European laboratories devoted to the elucidation of the molecular basis     of these disorders. Each laboratory will centralize all families with a subtype of autosomal     recessive (AR) CA (n=116) or SP (n=207) in order to efficiently map and identify the     responsible gene(s). Genome-wide scans are already underway in 61 families. Given the     expertise of the participants, the researchers expect to map and identify several genes     during the course of this project. The spectrum of mutations and phenotype/genotype     correlations will be analysed thanks to this unique series of patients with various     phenotypes. The knowledge gained will be immediately applicable to patients in terms of     improved positive diagnosis, follow-up and appropriate genetic counselling. In the long term,     models for genetic entity will be developed in order to understand the pathophysiology and to     identify new targets for treatment. The series of patients assembled and the precise     knowledge of natural history will facilitate the implantation of therapeutic trials based on     rational approaches.   "
175598|NCT00140842|"     This study will examine hormonal differences in ghrelin and growth hormone in obese and     normal weight adolescents and their relationship to body composition and insulin resistance.     The study will also investigate the effect of the macronutrient composition of a meal on     postprandial ghrelin levels and whether ghrelin responses will predict the degree of hunger     and caloric intake at a subsequent meal.   "
175599|NCT00140855|"     The purpose of this study is to determine whether immune therapy with anti-CTLA4 antibody is     effective in people with advanced synovial sarcoma.   "
175600|NCT00140868|"     The purpose of this study is to assess quality of life and bowel symptoms after treatment.The     main objective is to compare the effect on quality of life of minimally invasive bowel     surgery and endoscopic stent placement in the treatment of malignant large bowel obstruction.   "
175601|NCT00140881|"     A 53-week study to determine the effect of montelukast sodium when given to children (with     infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.   "
175602|NCT00140894|"     A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in     patients with Familial Adenomatous Polyposis.   "
175603|NCT00140907|"     To demonstrate that losartan (+ conventional therapy) compared to placebo (+ conventional     therapy) will reduce the number of RT patients who experience histological lesions of chronic     allograft nephropathy   "
175610|NCT00140998|"     The study attempts to evaluate if the way of administering estrogen, the principal female     hormone, via patches or orally, affects the way estrogen works in girls with Turner Syndrome.     These are girls who are very short and whose ovaries do not work. We will examine changes     bone, protein and fat metabolism under the influence of estrogen delivered by a patch trough     the skin vs estrogen taken orally. These studies are conducted while the girls are taking GH     therapy.   "
175611|NCT00141011|"     The primary purpose of this study is to determine whether a brief intravenous infusion of     ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.   "
175612|NCT00141024|"     The purpose of the study is to determine the safety of and immune response to the     investigational HIV vaccine, EP HIV-1090, in HIV uninfected adults.   "
175613|NCT00141037|"     Over the last 40 years, corticosteroids (steroids) have been an important part of drug     regimens used to prevent organ rejection and to maintain the immune health of individuals who     have received organ transplants. Unfortunately, the negative physical effects of steroids can     be severe, especially in children. The purpose of this study is to determine the safety and     effectiveness of a steroid-free treatment regimen for children and adolescents who have     received kidney (renal) transplants.   "
175614|NCT00141050|"     The purpose of this study is to compare the safety and efficacy of two doses of     dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD     (MPH) and placebo in children ages 6-12 diagnosed with ADHD.   "
175628|NCT00141232|"     The AFORRD trial is asking three important questions:      What proportion of people with Type 2 Diabetes are likely to be treated satisfactorily with a     fixed dose of a statin that lowers blood cholesterol levels to help reduce the risk of heart     disease? To what extent do omega-3 fatty acids lower blood triglyceride levels when given     with or without a statin? Are there simple techniques that can help people to take their     tablets on a regular basis?   "
175629|NCT00141245|"     To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.   "
175630|NCT00141258|"     To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized     dose schedule with dose adjustment based on clinical response and tolerability, compared to     placebo in subjects with partial seizures   "
175631|NCT00141271|"     This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in     outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are     required to undergo a washout period of at least 7 days of any prior med.   "
175632|NCT00141284|"     The purpose of this study is to confirm the safety, efficacy and delineate the     pharmacokinetic properties of nelfinavir in HIV/ Hepatitis C coinfected subjects with Child     Pugh A compensated cirrhosis and or Hepatic fibrosis   "
175633|NCT00141297|"     PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a     new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is     the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.   "
175634|NCT00141310|"     To determine the efficacy and safety of sildenafil citrate in the treatment of established     pre-eclampsia   "
175635|NCT00141323|"     The purpose of the study is to determine the safety and effectiveness of 2 doses of the     investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing     new spinal fractures in women with osteoporosis.   "
175636|NCT00141336|"     To evaluate the long-term safety and tolerability of pregabalin in patients with partial     seizures.   "
175637|NCT00141349|"     To determine the onset of action, safety and toleration of different formulations and doses     of UK-369,003 in patients with erectile dysfunction. Patients should have been previously     treated with PDE5 inhibitors and have been responders to the drugs. Duration of treatment is     4 weeks.   "
175638|NCT00141362|"     Evaluate long-term safety and efficacy of pregabalin in patients with chronic neuropathic     pain.   "
175639|NCT00141375|"     To evaluate long-term safety and efficacy of pregabalin in the treatment of neuropathic pain     after spinal cord injury.   "
175640|NCT00141388|"     To evaluate the long-term safety and efficacy of pregabalin in patients with partial     seizures.   "
175641|NCT00141401|"     To evaluate long-term efficacy and safety of pregabalin in patients with diabetic peripheral     neuropathy.   "
175642|NCT00141414|"     To evaluate the long-term safety of pregabalin in refractory partial epilepsy.   "
175643|NCT00141427|"     To assess the clinical improvement (change in seizure frequency), safety and tolerability of     patients with partial seizures following adjunctive therapy of pregabalin BID in addition to     existing standard AEDs.   "
175644|NCT00141440|"     The investigators' aim is to study the effect of cycling off criteria during pressure support     ventilation in COPD patients at two levels of PEEP and PSV.   "
175645|NCT00141453|"     The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus     placebo on the progression of diabetic renal disease.   "
175646|NCT00141466|"     The purpose of this study is to compare two different strategies to implement a new method to     identify patients with HNPCC, which appeared cost-effective and feasible. The effectiveness,     costs and feasibility of both of the implementation strategies will be assessed.   "
175647|NCT00141479|"     The purpose of this study is to investigate a safe treatment interruption interval(s) for     re-initiation of bifeprunox at a therapeutic dose. The study duration is approximately 7 to     10 weeks.   "
175648|NCT00141492|"     This study is to investigate how well Androgel, when tested against placebo gel, helps to     control blood sugar levels in males with type 2 diabetes who have low testosterone (the main     male hormone) blood levels and are taking oral diabetic medicines alone or in combination     with insulin.   "
175649|NCT00141505|"     The study is to evaluate the effect of bifeprunox on the pharmacokinetics of valproate in     subjects with Bipolar I Disorder after multiple dose administration.   "
175650|NCT00141518|"     The primary objective of this study is to collect health economic data depicting the initial     levels and natural progression over time of resource usage, Parkinson's disease (PD)-related     costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients     treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about     one-third were Duodopa-naïve prior to the start of the study.   "
175651|NCT00141531|"     A non-randomized, open-label phase II study to explore the feasibility, time to recurrence,     duration of response and safety of the adjuvant intravesical instillation of EOquin     (apaziquone) in patients with high-risk superficial bladder tumors, and the response and     duration of response in patients with carcinoma in situ of the bladder.   "
175652|NCT00141544|"     To determine whether treatment with ESTRATEST® Tablets is superior to treatment with     esterified estrogens tablets   "
175653|NCT00141557|"     To determine whether treatment with ESTRATEST® Tablets is superior to treatment with     esterified estrogens tablets   "
175654|NCT00141570|"     To determine whether treatment with ESTRATEST® H.S. Tablets is superior to treatment with     esterified estrogens tablets   "
175655|NCT00141583|"     Although ACE Inhibitors and Angiotensin Receptor Blockers are effective blood pressure     lowering agents, the exact mechanisms by which these agents lower BP are still not fully     understood. This study aims to compare the blood pressure and hormonal responses (plasma     renin activity and aldosterone) to the ACE inhibitor enalapril and ARB candesartan in     individuals with mild essential hypertension.   "
175738|NCT00142675|"     A randomized controlled trial to evaluate the effects of a 12-month telephone-supervised,     home-based physical activity intervention, delivered via health educators versus supervised,     trained peers, on physical activity patterns. Inactive men and women ages 50 years and older     will be randomly assigned to one of these two programs or to an attention-control arm.   "
175656|NCT00141596|"     The optimal treatment of drug resistant (defined as BP> 140/85 despite three     anti-hypertensive drugs including a diuretic) is not well defined. This study aims to test     the hypothesis that resistant hypertension is caused by excessive expansion of extracellular     fluid volume. A secondary objective is to study which of three different antihypertensive     drugs would be most useful in drug resistant hypertension.   "
175657|NCT00141609|"     High blood pressure (hypertension) affects up to 80% of all patients receiving haemodialysis     for chronic kidney disease (CKD). High blood pressure is a major cause cardiovascular disease     (i.e. strokes, heart attacks and heart failure) and, thereby, cardiovascular deaths in these     patients.      A significant cause of raised blood pressure in haemodialysis patients is thought to be due     to retention of salt in the body. In healthy people the kidneys excrete salt but the kidneys     of patients with CKD cannot do this, so salt has to be removed by dialysis. However dialysis     cannot remove as much salt as is necessary, and so it accumulates. This fact has been     recognized for many years, and health professionals caring for haemodialysis patients often     stress the importance of restriction of dietary salt intake.      However no research has looked in detail at the mechanisms by which salt raises blood     pressure in haemodialysis patients. It is likely that salt directly affects thirst, causing     patients to drink more and become overloaded with fluid. In addition, salt may have direct     effects on the blood vessel wall, causing failure of adequate blood vessel relaxation. Both     of these factors may raise blood pressure.      We will conduct a carefully controlled crossover study looking at the effects of a modest     reduction in salt intake on BP. During the course of the study, which will last eight weeks,     patients will receive both a 5 gram per day and a 10 gram per day salt intake. We will look     at how thirst, fluid intake, a number of markers of blood vessel function and blood pressure     differ on these two salt intakes.   "
175658|NCT00141622|"     Heart disease and stroke, known as cardiovascular disease, are major causes of death in     people with chronic kidney disease. Abnormalities of a metabolic pathway called the     “L-arginine-nitric oxide” pathway are thought to be particularly important in these people,     and previous research in animals has suggested that sodium (salt) affects part of this     metabolic pathway. The purpose of our research is to study the effects of sodium intake on     the “L-arginine-nitric oxide” pathway, and on blood vessel function, in patients with kidney     disease.   "
175659|NCT00141635|"     Implementation and Evaluation of Implementation of Quality of Life Diagnostics and Therapy in     Individual Patients with Breast Cancer. A prospective study including 170 patients, 5 clinics     and 38 general practitioners as coordinating doctors for quality of life therapies.     Correlational study including several comparisons such as patients and their doctors.   "
175660|NCT00141648|"     This trial is intended to determine the results obtained when standard treatment for Non     Hodgkin's lymphoma is applied to the disease in a rare subtype which arises in bone. Patients     in the study undergo a detailed assessment, then treatment with chemotherapy and     radiotherapy, followed by close monitoring.   "
175661|NCT00141661|"     A 10-week safety and tolerability study of a potential treatment for mild to moderate     Alzheimer's disease.   "
175662|NCT00141674|"     Donated red blood cells vary in how old they are, that is, how long they have been stored     since being collected from donors. Blood that has been donated is stored for a maximum of 42     days, after this time it is expired. That means that red blood cells that are given to     patients as a blood transfusion can be anywhere from a few days old to 42 days old. The     average age of blood that is given as a blood transfusion in this hospital is 21 days old.      As stored blood gets older its ability to carry oxygen may be reduced. Whether or not this is     important in patients with a brain injury is not currently known.      The purpose of this study is to try and determine if fresh blood (less than 5 days old) is     better than old blood (greater than 20 days old) in improving the supply of oxygen in     patients who have suffered an injury to their brain.   "
175663|NCT00141687|"     For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and     6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the     likelihood of cesarean section (CS)?   "
175664|NCT00141700|"     This study is being conducted to determine the safety, side effects, and response to a     combination of an established high-dose chemotherapy regimen, stem cell support and Rituximab     (which is a form of immunotherapy).   "
175665|NCT00141713|"     Etanercept (Enbrel) will be added to standard therapy for acute Graft-versus-Host Disease to     see if the effectiveness of standard therapy can be improved.      Partial Funding Source- FDA OOPD   "
175666|NCT00141726|"     The purpose of this study is to determine the effectiveness of etanercept in the treatment of     patients with sub-acute lung injury following a bone marrow transplant. This study will also     examine the toxicity of treatment with etanercept as well as whether there is an improved     quality of life in these patients.   "
175668|NCT00141752|"     This research will assess the accuracy of the Toronto Bedside Swallowing Screening Test     (TOR-BSST), a new dysphagia screening test for patients with stroke. The purpose of the     TOR-BSST is to predict the presence of dysphagia in stroke patients across their continuum of     care in a simple and efficient manner. This initial research will assess the accuracy of the     TOR-BSST in the acute and rehabilitative settings using videofluoroscopy as the gold standard     for comparison. The results from this research will also assess the stability of the TOR-BSST     across nursing, its primary user, and generate an estimate for the prevalence of dysphagia in     adult stroke patients in the acute and rehabilitative settings. Participants in this research     will be 315 stroke patients from several teaching centres in Ontario, namely 105 acute     patients from the University Health Network, Sunnybrook & Women's College Health Sciences     Centre, and Hamilton General Hospital, and 210 patients in the rehabilitation setting from     the Toronto Rehabilitation Institute and Parkwood Hospital, London. Both the TOR-BSST and     videofluoroscopic assessment will be administered within 24 hours of each other and     interpreted according to published preferred practice guidelines for dysphagia. This research     will be the first to implement and assess a standardised method for screening for dysphagia     in stroke patients across the continuum of stroke recovery.   "
175670|NCT00141778|"     Atrial fibrillation (AF) is the most prevalent, sustained type of irregular heartbeat and     affects over 2 million Americans. Post-operative AF, which leads to significant morbidity and     a prolonged hospital stay, complicates 20% to 40% of cardiopulmonary bypass (CPB) surgical     procedures. While recent studies indicate that interruption of the     renin-angiotensin-aldosterone system by either angiotensin-converting enzyme (ACE) inhibition     or AT1 receptor antagonism decreases the incidence of AF following a heart attack or     cardioversion (electric shock to the heart), its effect on the incidence of post-operative AF     has not been throughly studied. Studies in both animals and humans suggest that     inflammation-induced atrial remodeling plays an important role in the cause of AF. Recent     studies also provide evidence that activation of the renin-angiotensin-aldosterone system     induces inflammation, myocyte injury, proarrhythmic electrical remodeling, and fibrosis     through aldosterone.   "
175671|NCT00141791|"     The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg     given twice weekly in subjects with moderate to severe persistent asthma.   "
175672|NCT00141804|"     To study the efficacy and safety of the administration of Tacrolimus in combination with     Sirolimus for the prevention of acute rejection in patients after renal transplantation   "
175673|NCT00141817|"     The purpose of this study is to characterize the PK profile, safety and tolerability of     single and multiple doses of pantoprazole in children aged 1 through 11 years with     endoscopically proven GERD.   "
175674|NCT00141830|"     The primary objective of this study is to compare the efficacy and safety of 3 dose levels of     oral ERB-041 administered daily for 12 weeks versus placebo in subjects with active     rheumatoid arthritis who have had a suboptimal response to therapy with stable doses of     methotrexate (MTX).   "
175675|NCT00141843|"     The study will consist of two parts: a safety and efficacy period in which all subjects will     participate and a pharmacokinetic analysis period, in which 30 eligible subjects will     participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of     ReFacto AF in patients with Hemophilia A.   "
175676|NCT00141856|"     The primary objective of this telephonic heart failure specific patient education study is to     assess the incremental clinical, psycho-social, and functional lifestyle benefits of the     Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease     Management Program/Study) when added to standard care among veteran beneficiaries with a     heart failure diagnosis. A secondary objective is to assess the impact of the Health E Heart     Study on total system utilization costs.   "
175677|NCT00141869|"     This study will examine brain activity associated with the involuntary urges or uncontrolled     movements, called tics, experienced by people who have Tourette syndrome (TS). Before     people with TS actually develop a tic, whether it is a movement or a vocal tic (like a cough     or bark), they feel the urge to tic. This study will look at brain activity during the time     of this urge and how brain activity may differ in people with TS and without TS.      Healthy normal volunteers and patients with TS between 14 and 65 years of age may be eligible     for this study. Patients must have sensory tics in the facial region and must experience at     least a moderate premonitory urge. Candidates are screened with a medical history, brief     physical examination, and a questionnaire.      Participants undergo the following procedures:        -  Magnetoencephalography (MEG): This test records magnetic field changes produced by brain          activity. During the test, the subjects are seated in the MEG recording room and a cone          containing magnetic field detectors is lowered onto their head. Electrodes (small metal          disks) are placed on both sides of the face near the jaw. The recording may be made          while the subject receives small currents from the electrodes on the jaw. Subjects may          be asked a few questions about what they felt during the procedure.        -  Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves          to obtain images of body organs and tissues. During the procedure, the subject lies on a          table that can slide in and out of the scanner-a metal cylinder. Subjects may be asked          to lie still for up to 30 minutes at a time. They can communicate with the staff at any          time during the scan.        -  Somatosensory evoked responses: This test examines how sensory information travels form          the nerves to the spinal cord and brain in the nervous system. An electrode placed on          the arm, leg, or face delivers a small electrical stimulus that may tingle and cause a          twitch of a hand, foot, or face muscle. Additional electrodes may sometimes be placed on          the scalp, neck, and over the collarbone to record how the impulse from the stimulus          travels over nerve pathways.      Patients in the study are contacted for follow-up after the study. Follow-up will be     conducted by phone or email, according to the patients' convenience, and will consist of     reaffirming that there were no adverse events.   "
175678|NCT00141882|"     Randomized double-masked clinical trial of memantine in patients with glaucoma   "
175685|NCT00141973|"     A systemic treatment with corticosteroids has been advocated for various bacterial infectious     diseases. Since the production of CRP is down-regulated by corticosteroids, a smaller     increase or a more rapid decrease of this acute phase protein will:        1. suggest attenuated systemic inflammation, but        2. does not necessarily reflect adequate therapy of the infection.      For several reasons (good diagnostic tool for sepsis, induction not decreased by     immunosuppressive therapy), procalcitonin could be a better marker for activity of sepsis in     patients under corticosteroids. As this issue has not yet been examined the investigators     will prospectively study the time-course of PTC and CRP in a well-defined septic patient     group, that in adjunction to antibiotic therapy also received systemic corticosteroid     treatment and compare it to a similar group without corticosteroid treatment.   "
175731|NCT00142584|"     The purpose of this study is to evaluate long-term safety,tolerability and blood pressure     effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be     given alone or in combination with other drugs that are commonly used in the treatment of     hypertension   "
175679|NCT00141895|"     Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the     United States since 1988 as a gastric cytoprotective agent. Despite a focused campaign by the     manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several     years, gained widespread acceptance to effect the medical termination of pregnancy in the     second trimester, either alone or after pretreatment with mifepristone. The primary reasons     for this prompt incorporation into standard practice include its low cost and the lack of     stringent storage requirements.      Vaginal administration seems to be more efficacious than when given orally. The use of     sublingual misoprostol for first trimester abortions has been extensively investigated as     evidenced by the large number of publications comparing sublingual to other routes of     misoprostol for first trimester pregnancy termination, on the assumption that the sublingual     route would have a similar efficacy of the vaginal route. In addition, the sublingual route     would combine an easier administration with the added advantage of no restriction of mobility     after administration. There has been no previous report in the literature comparing the use     of misoprostol given sublingually to that given vaginally for the second trimester     termination following intrauterine fetal death. Our aim is to compare efficacy, safety and     patient satisfaction with misoprostol given vaginally (the current standard) to that given     sublingually.   "
175690|NCT00142038|"     Up to date there is no worldwide accepted standard chemotherapy for the 1st-line treatment of     advanced or metastatic gastric cancer.A combination of epirubicin, cisplatin and 5-FU (ECF)     is the best examined combination and widely used. Recent studies (Thuss-Patience et al, J.     Clin. Oncol. 2005) could show that a combination of docetaxel and 5-FU might be similarly     effective as ECF. 5-FU and docetaxel +/- cisplatin combinations are investigated by many     groups and may be a future reference treatment. Many data suggest that 5-FU infusion can be     replaced by oral capecitabine with equal efficacy.      As docetaxel/5-FU is probably similarly effective as epirubicin/cisplatin/5-FU and a     replacement of 5-FU infusion by capecitabine makes the chemotherapy more comfortable for the     patient we investigate in this study a chemotherapy of docetaxel and capecitabine as 1st-line     therapy for metastatic or advanced gastric cancer.   "
175691|NCT00142051|"     Randomized, double blind placebo controlled clinical trial to evaluate effectiveness and     safety of inhaled nitric oxide for the treatment of sickle cell painful crisis in pediatric     patients with sickle cell disease.   "
175680|NCT00141908|"     Preterm birth remains a major cause of perinatal morbidity and mortality in developing as     well as in developed countries. Despite major clinical research efforts aimed at reducing the     incidence of preterm births in the United States, the preterm birth rate reached its highest     level in 2 decades, 11.9% in 2001, which translates to a 27% rise since 1981. Much of this     increase may be accounted for by the increase in multiple gestations brought about by     assisted reproductive technology. Twin gestations accounting for 20% to 25% of all     pregnancies conceived following such procedures. Twin gestations are at a particularly     increased risk of preterm labor and they deliver at a mean gestational age of 37 weeks     compared to 40 weeks for singleton pregnancies. In a study by our group, we estimated that     about 54.5% of twin gestations would deliver prior to 37 completed weeks of gestation; i.e.     preterm.      Evidence regarding efficacy of interventions designed to prevent preterm birth has been     disappointing. Most well-designed clinical trials have failed to demonstrate any reduction in     preterm births with such interventions as home uterine activity monitoring, reduced physical     activity, administration of antibiotic or tocolytic therapy, and intensive and frequent     antenatal follow ups. Recently, progesterone has shown some promise in the prevention of     preterm birth among women with prior preterm births. Whether this intervention will prove     effective in other populations, such as women with multiple gestations, remains to be seen.      The objective of our study is to compare the effectiveness of weekly intramuscular injections     of 17-alpha Hydroxyprogesterone Caproate, a natural metabolite of progesterone, in preventing     delivery at less than 37 weeks of gestation in a population of 290 patients with twin     gestations between 16 and 36 weeks of gestation compared to a placebo. The data generated     will be invaluable in managing this group of patients that is considered at a very high risk     for preterm labor and delivery.   "
175681|NCT00141921|"     The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in     pediatric patients with moderate to severe psoriasis.   "
175682|NCT00141934|"     AD 452 is a new drug which is being developed for use in adult patients with RA. It is     believed that AD 452 may modify the underlying disease of RA as well as improving RA     symptoms, and in order to establish its efficacy and safety, AD 452 is being tested in a 3     month study. Patients enrolled in this study will already be taking methotrexate for their RA     and they will remain on methotrexate throughout the study. An earlier clinical study in 98     subjects with RA on stable background therapy investigated the pharmacokinetics, safety and     tolerability of AD 452 taken for one month. The drug was well tolerated and no significant     drug related adverse events were reported.   "
175683|NCT00141947|"     In this proposed study, we aim to investigate the effects of Bexarotene (Targretin; LGD1069;     4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) on     severity of psychopathology, cognitive impairment, and quality of life in schizophrenia     patients in an open label trial. The rationale behind add-on oral bexarotene to ongoing     antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation     hypothesis (Goodman, 1995) and the growth factors deficiency and synaptic destabilization     hypothesis (Moises et al, 2002) of schizophrenia. In this clinical trial, a novel regimen of     low dose bexarotene (Targretin, 75 mg/day) will be added for 6 weeks to the standard     treatment of 15 schizophrenia patients on stable antipsychotic treatment. Participants will     be assessed at baseline and after 2, 4 and 6 weeks of treatment. A battery of research     instruments will be used for assessment of efficacy and safety (psychopathology, and side     effects). In addition, cholesterol and triglyceride levels, liver and thyroid function tests     and a blood cell count will be monitored at baseline and during therapy.   "
175684|NCT00141960|"     Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in     the esophagus and heartburn, which may sometimes interfere with daily activities due likely     to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do     not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have     subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in     Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of     famotidine in subjects with non-erosive GERD.   "
175715|NCT00142376|"     The study is a chart review of all children admitted over a two year period with the     diagnosis of acute respiratory distress syndrome. Short term outcomes, such as mortality,     length of ventilation and length of stay, will be reviewed. Factors that impact these     outcomes will also be reviewed.   "
175732|NCT00142597|"     This study will determine the effectiveness of acupuncture versus a placebo in altering brain     activity and relieving pain due to fibromyalgia.   "
175686|NCT00141986|"     Type 1 diabetes is a common chronic disease of childhood. It is not yet preventable. Multiple     daily injections of insulin, tests of blood sugar, and careful dietary planning are required     lifelong to prevent long-term complications such as blindness and kidney failure. Recent     studies of potential risk factors in children with diabetes, along with studies revealing the     immunologic properties of vitamin D, and experiments in animals suggest higher doses of     vitamin D may prevent type 1 diabetes. For proof for human children, a randomized trial will     compare groups at risk randomly assigned to receive either the usual vitamin D supplement or     a higher amount, 2000 IU daily. This initial study is a small scale test of procedures.   "
175687|NCT00141999|"     The purpose of this study is to determine the immune response to an additional (booster) dose     of hepatitis B vaccine 5-14 years after a three dose series was given   "
175688|NCT00142012|"     The overarching goal of this initiative is to reduce the prevalence and occurrence of obesity     and increase the remission of obesity in children and adolescents through implementation of a     Comprehensive School Nutrition Policy designed to promote changes in the school environment     that will reinforce students’ development of healthy eating and physical activity patterns     inside and outside of school.   "
175689|NCT00142025|"     The purpose of this study is to determine whether antiepileptic drug oxcarbazepine is     effective in the treatment of chronic asthma.   "
175708|NCT00142285|"     The purpose of this study is to determine whether zinc can be used in combination with     standard antibiotics to reduce the duration of illness and the likelihood of treatment     failure among children less than two years old who have non-severe, outpatient pneumonia.   "
175709|NCT00142298|"     This trial is being conducted as an open-label, extended-term study for patients with chronic     hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.   "
175739|NCT00142688|"     The purpose of this study is to examine psychosocial mediators of exercise behavior.   "
175692|NCT00142064|"     The purpose of this study is to determine if a single application of Lidocaine gel topical     anesthesia is as effective in decreasing the discomfort associated with urinary     catheterization as two applications, within our pediatric population. Currently, two     applications is our standard of care within our pediatric Radiology Department. Urinary     catheterization is the process of placing a flexible tube into the urinary opening (urethra),     to drain urine or instill radiographic solution for study of the anatomy and/or function of     the urinary system. Members of the study team hypothesize equivalence in the observer     reported catheterization pain scores as measured by the FLACC pain scale. The study is     designed to obtain conclusive data to guide clinical practice.      The study team hypothesizes that statistically similar levels of analgesia will be observed     with the single application procedure as compared to the multiple application technique.   "
175693|NCT00142077|"     The purpose of this study is to determine whether personally controlled electronic health     records can be used for health promotion in a workplace setting.   "
175694|NCT00142090|"     The purpose of this study is to find out if 3% hypertonic saline (salt-water solution) given     in a vein improves the headache that may be caused by a concussion. 3% hypertonic saline may     also improve some of the other symptoms that may be caused by concussion (for example:     confusion, nausea, vomiting).      This research is being done because there have been previous experience which suggests that     3% hypertonic saline has been beneficial in the treatment of children with more severe brain     injury.   "
175695|NCT00142103|"     1. To characterize the tolerability profile of subcutaneous (SC) CPG 10101 alone, with          pegylated interferon, ribavirin or both pegylated interferon and ribavirin when          administered weekly for twelve weeks in relapsed HCV positive subjects.        2. To assess the effect of subcutaneous (SC) CPG 10101 alone, with pegylated interferon,          ribavirin or both pegylated interferon and ribavirin on serum Hepatitis C Virus (HCV)          RNA concentrations   "
175696|NCT00142116|"     The purpose of this study is to determine the percentage of people who can attain remission     and the length of time such responses to therapy are sustained, as well as the side effects     that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.   "
175697|NCT00142129|"     The purpose of this study is to evaluate how tumors in patients with Waldenstrom's     macroglobulinemia respond to treatment with bortezomib (Velcade) and to see what effects     (good and bad) it has on the cancer.   "
175698|NCT00142155|"     The purpose of this study is to determine if the type of Fc gamma RIIIa receptor that a     particular patient's immune cells possess influences how they respond to rituximab and other     monoclonal antibodies.   "
175699|NCT00142168|"     The purpose of this study is to determine the number of patients with Waldenstrom's     macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab,     what the side effects are and how long the benefit will last.   "
175700|NCT00142181|"     The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H     antibody in the treatment of lymphoplasmacytic lymphoma.   "
175701|NCT00142194|"     Atrial fibrillation is an abnormal heart beat that starts in the upper parts of the heart and     can cause stroke or death, if untreated. In general, treatments are not very effective, with     frequent relapses of the abnormal heart beats. One explanation for the high relapse rate is     that the treatments might not address the underlying cause of atrial fibrillation. Recently,     the investigators have found that atrial fibrillation is associated with increased oxidative     stress. This is a condition where abnormal oxygen forms are produced. These forms harm the     cells of the heart, causing them to beat abnormally. The investigators have found increased     oxidative stress in pig and mouse models of atrial fibrillation. They would like to see if     oxidative stress is present in humans with atrial fibrillation. In this study, they will     compare blood markers of oxidative stress between patients with and without atrial     fibrillation. It is the expectation that participants with atrial fibrillation will have more     abnormal blood markers of atrial fibrillation. This study requires participants to visit     their doctors, undergo a history and physical examination, and give blood only once.   "
175728|NCT00142545|"     The current protocol is designed to satisfy the need for a compassionate use treatment     protocol as well as for a long-term open label follow-up study.   "
175729|NCT00142558|"     A study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute     gout.   "
175702|NCT00142207|"     The purpose of this study is to compare the efficacy and cost-effectiveness of three     alternative strategies for the prevention of malaria during pregnancy in an epidemic-prone     area of low transmission in the East African Highlands.      The strategies being compared are:        -  intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)        -  an insecticide treated net (ITN), and        -  intermittent preventive treatment with SP plus an ITN      In addition to the main individually-randomised trial, outcome data was subsequently also     gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS)     as part of a non-randomised district-wide control programme to compare the impact of IRS with     the three intervention arms.   "
175703|NCT00142220|"     We study whether an increased proportion of omega-3-fatty acids (contained in fish oil) in     the nutrition of critically ill patients reduces systemic inflammation.   "
175704|NCT00142233|"     This is a multi-centre randomised phase III, double blind, placebo controlled, parallel     group, outpatient study in patients diagnosed with hereditary pancreatitis and idiopathic     chronic pancreatitis.      The hypothesis to be tested is a 30% reduction in the number of days due to pancreatitis from     12.5 days per year to less than nine days per year under the treatment with magnesium or an     antioxidant cocktail called ANTOX.      A total of 240 patients will be randomised to one of three treatment groups in order to     compare pancreatic pain over a twelve month period.   "
175705|NCT00142246|"     This study seeks to establish whether intermittent preventive treatment (IPT) can reduce     malaria among school-going children and its consequent impact on school performance.   "
175706|NCT00142259|"     The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain     stimulation of the internal globus pallidus for treating idiopathic generalized or severe     segmental dystonia.   "
175707|NCT00142272|"     The study will be conducted to compare the efficacy and safety of a single dose of     ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension     administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children,     aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139.      We hypothesize that single dose ciprofloxacin would result in similar outcome in the     clinicalcurewith that of erythromycin given in multiple doses.   "
175710|NCT00142311|"     Parkinson’s disease is one of the most frequent neurodegenerative diseases, and for which the     mechanisms remains unknown. Since the implication of susceptibility factors is highly     suspect, we have recently shown that one monogenic form due to alterations in the Parkin gene     was responsible for an important proportion of early onset familial and isolated cases.     Nevertheless, it not has been determined yet the relationship between idiopathic Parkinson’s     disease and secondary Parkinson’s disease with a Parkin gene mutation at the clinical,     neuropsychological, metabolic and physiopathological levels. For establishing     phenotype-genotype correlations, we propose to compare the phenotype of patients carrying a     Parkin mutation (parkin « + », n=25) to those of early onset parkinsonians without a Parkin     mutation (Parkin ” - ”, n = 25), and for some aspects (neuropsychological, behavioural and     psychiatric evaluations) to the healthy brothers and sisters of Parkin cases “+”(n = 25). The     evaluation will carry on the clinical aspects (quantification of the parkinsonian syndrome     and reactivity to levodopa, neuropsychological, behavioural and psychiatric evaluations),     molecular (types of abnormalities in the Parkin gene) and metabolic (PET – tomography by     positron emission) of the disease.      Parkinson’s disease caused by Parkin gene mutations is associated with an important and     homogeneous loss of dopaminergic neurons of the substantia nigra pars compacta, which is     different from those observed during the idiopathic Parkinson’s disease. The corresponding     dopaminergic deficit should be associated with an excellent reactivity to levodopa, to a     cognitive deficit and to behavioural and/or psychiatric attitudes, in relation with the     massive alteration of dopaminergic efferences.      This multidisciplinary approach on Parkin cases will be performed in the centers for of     clinical investigations of Grenoble and Paris, with the help of the French Parkinson’s     Disease Study Group, and two centers for TEP (Lyon and Orsay). This project will allow to a     better definition of diagnostic criteria of Parkin « + » cases, which will help for the     molecular diagnosis in early onset cases, and will study precisely the clinical, psychiatric     and metabolic consequences of a massive and homogeneous dopaminergic denervation, which seems     to be different of idiopathic Parkinson’s disease.   "
175711|NCT00142324|"     Primary Aim      To determine whether;        -  Donepezil is significantly better than placebo in the management of agitation in          Alzheimer's Disease that has not responded to, or is inappropriate for a standardised          brief psychosocial treatment      Secondary Aims      To determine whether;        -  Donepezil has a significant positive or negative impact upon quality of life compared          with placebo        -  whether there is a significant difference between Donepezil and placebo with respect to          cognitive performance        -  the cost effectiveness of the pharmacological treatment for agitation   "
175712|NCT00142337|"     The purpose of this study is to determine whether providing zidovudine (ZDV) and didanosine     (ddI) during labor and for one month postpartum can reduce the selection of nevirapine (NVP)     resistance mutations postpartum in women who received a single dose of nevirapine during     labor and standard ZDV prophylaxis for the prevention of mother to child transmission of HIV.   "
175713|NCT00142350|"     To investigate the superiority of a combination of irinotecan and cisplatin and the     non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer   "
175714|NCT00142363|"     The DNA and Cell Bank of Instituts Federatifs de Recherche (IFR) of Neurosciences has been     running for the last 15 years at the Institut National de la Santé Et de la Recherche     Médicale (INSERM) Unit 679 (former unit 289). Since its creation, this structure has been the     support of research projects in genetics for neurological and psychiatric disorders. The     cohorts established have led to discoveries in monogenic disorders, such as cerebellar     ataxias, spastic paraplegias, frontotemporal dementias, epilepsies, Parkinson’s and     Alzheimer’s disease, Charcot-Marie-Tooth disease and related entities. The research projects     based on the study of the genetic bases in Parkinson’s disease and epilepsies are especially     developed for this grant.      Concerning Parkinson’s disease, the project is based on the extension of the existing cohort     throughout the French Parkinson’s Disease Study Group network. Concerning epilepsies, this     project is the occasion to build this network with the constitution of a new cohort.      The specific aims of the scientific projects are the following for Parkinson’s disease:        -  to evaluate the frequency, the nature and the phenotype associated with parkin mutations          in familial or sporadic forms of the disease, according to the age at onset, and        -  to identify the genetic susceptibility factors in Parkinson’s disease with the study of          affected sibpairs and with case/controls association studies.      For epilepsies, the aims are:        -  to evaluate the frequency, the nature and the phenotype associated with SCN1A, SCNab and          GABR2 gene mutations in familial or sporadic forms of the affection associated with          febrile seizures, and        -  to search for an intervention SCN1A, SCN1B and GABRG2 as susceptible genes in these          forms of epilepsies.   "
175730|NCT00142571|"     The purpose of this study is to compare the drug gemcitabine to two drugs, gemcitabine and     docetaxel, to find out which treatment is better for people with sarcomas.   "
175716|NCT00142389|"     This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant     mothers, followed by pneumococcal conjugate immunization of their children is designed to     assess the effects of these strategies on the immunogenicity and safety of both vaccines. We     hypothesize that maternal followed by infant immunization will be safe and will provide     higher levels of antibody from birth through 12 months of age.   "
175717|NCT00142402|"     Deficits in new learning and memory in MS are a major complaint of patients, and have been     noted to be a significant contributor to disability by numerous researchers. Modafinil is a     psychostimulant medication, FDA approved for the treatment of Narcolepsy, with potential     application for the treatment of learning and memory dysfunction in MS. This randomized     clinical trial tests the efficacy of Modafinil for the treatment of new learning and memory     deficits in MS.      Twenty subjects with clinically definite MS and objectively documented new learning     impairment will be included in the study. All subjects will undergo baseline     neuropsychological testing and EDSS to document current levels of functioning in new learning     and memory abilities. Subjects will then be randomly assigned to either group 1 or group 2.     Group 1 (n=10) will first undergo treatment with Modafinil (200 mg once per day in the     morning) for 2 weeks. They will then undergo follow-up neuropsychological assessment and     follow-up EDSS to evaluate any medication effects. After the follow-up evaluation, there will     be a washout period of one week in which no medication will be administered. Group 1 will     then receive a placebo medication for 2 weeks. A second follow-up evaluation will be     conducted following this latter arm of the study. Group 2 (n=10) will follow the same     pattern, but will receive the placebo medication during the first arm of the study and     Modafinil during the 2nd arm of the study. The subjects and the experimenter administering     the neuropsychological evaluation will be blind to group membership.   "
175736|NCT00142649|"     To develop a culturally tailored intervention intended to promote adherence to nutrition and     physical activity regimens designed to result in weight loss for African American women.   "
175737|NCT00142662|"     To investigate two cafeteria-based methods of weight gain prevention in overweight men and     women.   "
175718|NCT00142415|"     This was a Phase I/II, single-center, dose-escalation study.     177-Lutetium-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid-cG250     (177-Lu-DOTA-cG250) was administered at a starting dose of 30 mCi/m^2 of 177-Lu (fixed dose     of 10 mg cG250) and escalated in increments of 10 mCi/m^2 of 177-Lu in sequentially enrolled     cohorts according to a standard 3 + 3 design until determination of the maximum tolerated     dose (MTD). The primary objectives were to determine the safety, targeting, and dosimetry of     177-Lu-DOTA-cG250 in subjects with advanced renal cell carcinoma. The secondary objective was     measurement of tumor response according to the Response Evaluation Criteria in Solid Tumors     (RECIST) version 1.0.   "
175719|NCT00142428|"     The main purpose of this study is to begin to collect information and to try to learn whether     or not cetuximab works in treating patients with unresectable or metastatic hepatocellular     carcinoma.   "
175720|NCT00142441|"     To investigate the effect of pulse width on the treatment response of keloidal and     hypertrophic sternotomy scars to a 595-nm pulsed dye laser   "
175721|NCT00142454|"     This study evaluates a cancer vaccine in melanoma patients who have resected melanoma but are     at high risk for recurrence (stages IIB-III). This is a single arm, open label, pilot/phase I     study evaluating safety and immunogenicity of NY-ESO-1 protein vaccination with Imiquimod as     an adjuvant.      Imiquimod is a FDA approved immune response modifier for the treatment of HPV associated     genital warts (but used for a different indication here) and has been shown to attract and     mature dendritic cells in areas of topical application. This will be utilized in this     application to inject a protein vaccine into this site, to prime and boost anti-NY-ESO-1     immune responses.      9 patients will be treated to receive 4 vaccination cycles, 21 days apart. Each vaccination     cycle consists of topical application of Imiquimod 250mg to healthy skin of extremities for     the first five days of each cycle and intradermal injection of NY-ESO-1 protein 100mcg to the     pretreated area on day 3.      Immunization will be assessed by T-cell assays, NY-ESO-1 specific antibody titers, and     evaluation of 3 small skin biopsies.   "
175722|NCT00142467|"     The purpose of this study is to test the safety of bevacizumab when given in combination with     gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with     hepatocellular carcinoma.   "
175723|NCT00142480|"     The main purpose of this study is to test the safety and effectiveness of oxaliplatin,     bevacizumab, and capecitabine given in combination with radiation therapy to see what effects     (good or bad) they have on patients with biliary tract and gallbladder cancer.   "
175724|NCT00142493|"     The purpose of this research is to understand how some of the drugs commonly used in     anesthesia impair memory. We are particularly interested in whether the emotion associated     with a memory influences how well these drugs are able to block memory. We are studying four     commonly used drugs—propofol, thiopental, midazolam, and dexmedetomidine, all of which may     have slightly differing effects. We will also study an inactive substance, called a placebo,     that should have no effect. The results of this study will provide information that will be     useful in understanding how memory works, how these drugs affect memory, and possibly why     some people don't have their memory blocked as easily as others.   "
175725|NCT00142506|"     Radiation sometimes affects the ability for a person to have a normal erection. Complete loss     of erections after radiation treatment can happen in 40-50% of treated patients. There are     medications, like sildenafil (also known as Viagra), that can help the ability to get back     erections in almost 70% of such patients.      The purpose of this study is to see if taking Viagra every day starting right before, during     and for about 6 months after treatment, could reduce the risk of long-term erectile     dysfunction.   "
175726|NCT00142519|"     This is a randomized Phase II study testing the effectiveness of the combination of morphine     and methadone versus morphine alone in relieving pain. A second goal is to further evaluate     any side effects of the combination of morphine and methadone.   "
175727|NCT00142532|"     Pain after surgery for lung cancer (thoracotomy) may persist for years and require long-term     analgesic use. Prior studies have shown that acupuncture reduces pain and medication use in     the early post-operative period after abdominal surgery, suggesting that acupuncture may have     a role in preventing chronic post-thoracotomy pain. This study is being done in order to     determine the effects of acupuncture on pain in patients undergoing surgery for lung cancer.   "
175735|NCT00142636|"     Patients with Chronic Kidney Disease (CKD) have been shown to have high coronary calcium     scores (CAC), but the temporal association between Glomerular Filtration Rate, CVD risk     factors and CAC has not been described. This is a single-center, longitudinal, observational     study. Subjects included adults aged 18 years to 65 years old without preexisting coronary     artery disease (CAD). The CKD subjects (GFR < 60 ml/min) and the control subjects (GFR     >/=60ml/min) were recruited. Laboratory measurements and MDCT scan were performed at baseline     and after 12 months. Baseline CAC and average intact parathyroid hormone (iPTH) level were     significantly greater in the CKD group. Baseline CAC scores of the CKD group were twice the     value of the control group; however, CAC scores over one year were unchanged from baseline.   "
175741|NCT00142714|"     The long term aims of this project are to 1) Understand the effect of varying degrees and     levels of SCI and dysfunction(SCI/D)on females sexual response: 2) Identify the specific     neuronal pathways involved in female sexual responses; and 3) Develop and evaluate new     assessment and treatment methods for neurogenic sexual dysfunction in women.   "
175742|NCT00142727|"     The purpose of this study is to examine the acute agonist and antagonist effects of a full     opioid agonist medication, an opioid antagonist medication, and a partial opioid agonist     medication in individuals who have different levels of physical opioid dependence.   "
175743|NCT00142740|"     This laboratory-based substudy of an effectiveness trial of two Hepatitis B vaccines in     HIV-negative youths is being done to evaluate the genetic contribution to the individualized     immune response.   "
175744|NCT00142753|"     This is an exploratory, laboratory-based evaluation of cellular immune response to     immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents.     This is a substudy of ATN 024 and ATN 025. This substudy will compare cellular immune     response in responders and nonresponders to immunization and also evaluate the relationship     of these factors to the persistence of known correlates of serologic protection for the     hepatitis B virus.   "
175745|NCT00142766|"     The purpose of this two-year project is to pilot test an intervention to change sedation     management in pediatric patients supported on mechanical ventilation for acute respiratory     failure in the pediatric intensive care unit (PICU). While ensuring patient comfort is an     integral part of pediatric critical care, analgesic and sedative use in this patient     population is associated with injury; specifically, comfort medications may depress     spontaneous ventilation and prolong the duration of mechanical ventilation. Additionally,     drug tolerance develops over time and may precipitate iatrogenic abstinence syndrome     (chemical withdrawal) when the patient no longer requires sedation. Alternatively, suboptimal     comfort management contributes to the patient not breathing synchronously with the ventilator     and/or self-removal of breathing tubes.      Our group has developed and validated a nurse-implemented sedation algorithm (set of specific     instructions) to guide titration of comfort medications that may optimize patient comfort and     reduce the risk of under-medication, but this algorithm needs to be evaluated further. We     hypothesize that pediatric patients managed per sedation protocol will experience fewer days     of mechanical ventilation than patients receiving usual care. This research has the potential     of revolutionizing sedation practices that are driven by and synchronized to patient needs.   "
175746|NCT00142779|"     Cocaine addiction is a serious health problem with no available medical treatment for     preventing relapse. Fluoxetine, a medication that is currently used to treat depression and     anxiety disorders, may also be effective at diminishing cocaine use in individuals with     severe cocaine addiction. This study will evaluate the effectiveness of fluoxetine at     reducing cocaine use in individuals addicted to cocaine and opioids who are concurrently     receiving methadone treatment.   "
175747|NCT00142792|"     Stroke is the leading cause of activity limitation among older adults in the United States.     NeuroMuscular Electrical Stimulation (NMES) can assist stroke survivors in regaining motor     ability and decreasing activity limitation caused by stroke. This study will research the     effects of two types of NMES on reducing motor impairment and activity limitation.   "
175748|NCT00142805|"     The purpose of this study is to evaluate the safety, tolerability and effectiveness of     Ketasyn™ administered once a day for ninety days in subjects with mild to moderate, probable     Alzheimer's disease.   "
175749|NCT00142818|"     Modafinil is a medication that may enhance mood and increase energy in cocaine addicts, which     may be useful in preventing cocaine relapse. Naltrexone is a medication that is currently     used to treat drug and alcohol addiction. A combination of these two medications may be     beneficial in reducing drug and alcohol use in individuals undergoing substance abuse     treatment. The purpose of this study is to evaluate the effectiveness of modafinil and     naltrexone, alone and in combination, at reducing drug and alcohol use in individuals     addicted to cocaine and alcohol.   "
175750|NCT00142831|"     Existing and new pharmacotherapies along with prevention efforts are key to improving smoking     cessation rates and reducing the premature morbidity and mortality associated with tobacco     use. A number of individuals suffer from both nicotine dependence and depression. The purpose     of this study is to determine the effectiveness of bupropion used in combination with the     nicotine replacement patch and cognitive behavior therapy (CBT) in treating nicotine     dependent individuals also diagnosed with depression.   "
175751|NCT00142844|"     Many cocaine dependent individuals are also dependent on alcohol. Such individuals respond     poorly to existing treatments and have received little research attention in the past. The     purpose of this study is to determine whether the combination of naltrexone and disulfiram is     useful in decreasing alcohol use and cravings in people diagnosed with both cocaine and     alcohol dependence.   "
175752|NCT00142870|"     A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy     marijuana use. Bupropion (Zyban) is a medication currently used to treat withdrawal symptoms     associated with tobacco use. The purpose of this study is to determine if bupropion will help     individuals stop using marijuana.   "
175753|NCT00142883|"     Gamma-aminobutyric acid (GABA) is a type of neurotransmitter, which is a chemical that     transmits information within and from the brain to all parts of the body. By lowering the     level of another neurotransmitter called dopamine, GABA may have the ability to diminish     cocaine cravings in addicts. The purpose of this study is to gather information on the     interaction between cocaine and selected GABA enhancing medications in individuals addicted     to cocaine. This may lead to future clinical studies using GABA medications to treat cocaine     addiction.   "
175754|NCT00142896|"     Individuals with opioid addiction often experience serious withdrawal symptoms that may make     relapse unavoidable. Tramadol, a medication that is currently used to treat pain caused by     chronic conditions such as cancer or joint pain, may also be effective at reducing opioid     withdrawal symptoms. This study will evaluate the effectiveness of tramadol at reducing     withdrawal symptoms in individuals addicted to opioid drugs.   "
175755|NCT00142909|"     Lofexidine is an experimental medication that may be beneficial in reducing opiate withdrawal     symptoms, such as sleep difficulty, anxiety, and tension. The purpose of this study is to     determine whether lofexidine in combination with naltrexone can improve an individual's     ability to cope with stress and subsequently increase the chances of remaining abstinent from     opiates.   "
175756|NCT00142922|"     Performance of self-care recommendations is key to the successful treatment of diabetes.     However, many patients have difficulty adhering to diabetes self-care recommendations. Recent     results from our own studies and others have identified specific barriers to diabetes     self-care. To evaluate the efficacy of a diabetes educator-led group intervention, the     Breaking Down Barriers Program, that addresses barriers and therefore leads to improved     adherence to diabetes self-care recommendations, we will randomize 222 (111 type 1 and 111     type 2) diabetes patients to one of three conditions: 1) the Breaking Down Barriers Program,     2) a cholesterol attention control condition, or 3) a 'usual care' control condition. We     hypothesize that those assigned to the Breaking Down Barriers group will improve self-care     behaviors and glycemic control more than those in the two control groups. We will follow     study subjects for one year to determine whether their self-care behaviors and glycemic     control improved and if the improvement was maintained over time.   "
175757|NCT00142935|"     Much of the HIV/AIDS epidemic is driven by transmission from or to persons addicted to     opiates. Many of these individuals pass through a correctional setting each year, creating an     opportunity for linkage to substance abuse treatment. The purpose of this study was to     evaluate the effectiveness of initiating opiate replacement therapy prior to release from     incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study     evaluated the effectiveness of short-term payment versus non-payment of community opiate     replacement therapy immediately following release from incarceration.   "
175758|NCT00142948|"     Naltrexone is a medication that is currently used to treat drug and alcohol addiction.     Guanfacine is a medication that is currently used to manage the withdrawal symptoms in     individuals undergoing opioid detoxification. A combination of these two medications may be     beneficial in reducing heroin use in individuals addicted to heroin. This study will evaluate     the effectiveness of naltrexone and guanfacine, alone and in combination, at reducing heroin     use in heroin addicts.   "
175759|NCT00142961|"     Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment     for marijuana dependence. The purpose of this study is to determine the use of atomoxetine in     treating adolescents who abuse marijuana and have ADHD. In addition, this study will assess     whether atomoxetine reduces ADHD symptoms as compared to a placebo. Finally, the study will     determine whether atomoxetine improves treatment retention and progress in adolescents with     ADHD and marijuana dependence.   "
175760|NCT00142974|"     This study is being done to evaluate the safety, tolerability and satisfactory relief of     tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic     gastropathy.   "
175761|NCT00142987|"     Recent literature has demonstrated that the group of IBS sufferers who experience mixed bowel     habits may be more similar to IBS-C patients than IBS-D patients. This study will evaluate     the efficacy and safety of tegaserod 6 mg b.i.d. in women with IBS and mixed bowel habits,     excluding those with predominant diarrhea.   "
175762|NCT00143000|"     The primary objective of the study is to demonstrate that the efficacy of peginterferon     alfa-2a 40KD combination therapy with ribavirin in interferon naïve patients with chronic     hepatitis C virus infection genotype 2 or 3 given for 12 weeks is non-inferior to 24 weeks.   "
175763|NCT00143013|"     Type 2 diabetes is a disorder of the metabolic system that greatly affects individual health     and imposes significant cost for society on health care. It is necessary to initiate research     with emphasis on improvement on quality of life and reduce the serious complications as a     result of type 2 diabetes.      In type 2 diabetes insulin resistance and impairment of insulin secretion by beta-cells are     the major pathophysiological defects and characterized by raised plasma glucose levels.     Today, little is known about gene regulation and biochemical pathways involved in the     disease.      Bioinformatics and gene expression microarrays (GEM) will be applied to gain insight into the     molecular pathophysiology of type 2 diabetes. The simultaneous monitoring of thousands of     genes in parallel can identify novel genes and entire biochemical pathways that are     dysregulated at the transcriptional level. Affymetrix Inc. chips or spotted arrays will be     applied as DNA microarray tools. Bioinformatic software programs and databases will be     employed as data mining tools in order to perform statistical analysis, cluster analysis and     biochemical pathway analysis.      Biopsies from skeletal muscle and adipose tissue from both diabetics and nondiabetics will be     applied. Changes in genes and biochemical pathways between diabetics and nondiabetics and     functional relationships between adipose tissue and skeletal muscle will be investigated.      Grouping of subtypes in type 2 diabetes will be performed and a classification system will be     constructed. Building a classifier may provide better and more precise diagnosis of type 2     diabetes.      Major advances in health science of type 2 diabetes thus seems to be promising and paving the     way for individual treatment based on a more precise diagnosis.   "
175764|NCT00143026|"     This study examines the effect of treatment of levodopa/entacapone on quality of life, as     measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients     with no or minimal, non-disabling motor fluctuations.   "
175765|NCT00135161|"     The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography     (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).   "
175766|NCT00135174|"     The overall objective of the study is to quantify the true prognostic value and     cost-effectiveness of routine follow-up visits in patients who receive an approved pacemaker     of any type for the first time.   "
175922|NCT00143039|"     The objective of this pilot study is to prospectively evaluate amniotic fluid of pregnancies     complicated by non-immune hydrops and severe symmetrical intrauterine growth restriction by     tandem mass spectrometry for inborn errors of metabolism.   "
175790|NCT00135486|"     The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and     reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C     polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK     Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different     formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant     vaccines were given to all children to complete the vaccination agenda.   "
175791|NCT00135499|"     The primary objective of this study is to evaluate the efficacy of doxorubicin,     cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison     to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients     aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as     measured by the event-free survival. The goal is to obtain a 10% increase of event-free     survival at 3 years.   "
175792|NCT00135512|"     This study was designed to evaluate the efficacy and safety in major depressive disorder     patients.   "
175767|NCT00135187|"     Patients are being asked to take part in this research study because they have multiple     myeloma which has relapsed after (come back), or is refractory to (unaffected by), initial     therapy.      For patients who have relapsed or are refractory to therapy, there is no agreed upon standard     treatment. Treatment options include chemotherapy and, for some patients, bone marrow     transplants. None of the available treatments are curative and investigators are continually     looking for more effective treatments. This study involves treatment with a new combination     of standard drugs: VELCADE, Doxil, and Dexamethasone. Preliminary results from a study using     a combination of VELCADE with Doxil showed high response rates (disease reduction). Two other     studies showed that an addition of Dexamethasone to VELCADE in patients not responding to     VELCADE alone improved response rate. The proposed combination of all three drugs may improve     efficacy and response.      VELCADE is approved by the Food and Drug Administration (FDA) for use in multiple myeloma.     Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients     with some other cancers. Several published clinical trials provide evidence that Doxil is an     active agent in multiple myeloma and it is used in treatment combinations for multiple     myeloma in general practice. Dexamethasone is approved for use in multiple myeloma. The     combination of all three drugs is experimental (not FDA approved).      The goals of this study are to determine if this new combination therapy with VELCADE, Doxil     and Dexamethasone is an effective treatment, and also to determine the side effects that     occur when this combination treatment is given.   "
175768|NCT00135200|"     This study is for patients with newly diagnosed or relapsed multiple myeloma. The main     purpose of this study is to see how their disease responds to consolidation treatment     (treatment aimed at further decreasing cancer cells) with a radioactive antibody (protein)     called iodine I 131 tositumomab (known by the tradename Bexxar®) and also to look at the side     effects which occur with this type of treatment. The investigators will also be looking at     how long disease responds to treatment, if it responds at all, and how long patients who have     had this treatment survive.      Bexxar is a monoclonal antibody (protein) to which radioactive iodine 131 is attached. The     monoclonal antibody in Bexxar (tositumomab), targets a protein called CD20 found on the     surface of a variety of B-cells, including lymphoma cells, and some myeloma cells. The     antibody is given as an infusion and finds its way to these cells. The radioactive iodine     attached to the antibody delivers radiation directly to these cells which works to harm or     kill the cancer cells. Approximately 20-25% of patients with multiple myeloma have this     protein on the surface of their tumor cells. In addition, this protein was found on the     surface of myeloma stem cells. While myeloma stem cells represent a minority of all myeloma     cells (less than 5%), these cells are resistant to chemotherapy and are believed to be     responsible for a recurrence of the disease after chemotherapy. In this study, Bexxar will be     used after patients complete a course of chemotherapy and have residual myeloma cells left in     their body. The Investigators are hoping that the treatment with Bexxar will decrease and     possibly eliminate residual myeloma cells resistant to chemotherapy.   "
175769|NCT00135213|"     The investigators' long-term goal is to improve the quality of services targeting the     prevention of secondhand smoke (SHS). Their specific aims are to:        -  refine components of office systems and counseling interventions for parental tobacco          control in pediatric outpatient settings; and        -  pilot test the feasibility and efficacy of a parental tobacco control randomized          controlled trial in pediatric office settings using 5 intervention and 5 comparison          pediatric practice sites.      The investigators hypothesize that:        -  clinicians in intervention practices (compared to those in control practices) will more          often implement successful office systems, screen for parental smoking, advise parents          to quit and to prohibit smoking and SHS exposure at home, recommend pharmacotherapy,          provide adjuncts, and refer parents to cessation programs; and        -  parents who smoke in intervention practices (measured by 3-month follow-up telephone          surveys) will be more likely than those in control practices to have received cessation          services, use pharmacotherapy, make lasting quit attempts, and institute rules to          prohibit smoking and limit SHS exposure at home.   "
175770|NCT00135226|"     The purpose of this study is to determine whether 100mg daily aspirin versus placebo and/or     supplementation with 1 gram daily omega-3 fatty acids or placebo prevents serious vascular     events (i.e. non-fatal heart attack, non-fatal stroke or transient ischaemic attack, or     death from vascular causes) in patients with diabetes who are not known to have occlusive     arterial disease and to assess the effects on serious bleeding or other adverse events.   "
175771|NCT00135239|"     The most common work-related injury in British Columbia every year is a lower back injury.     The many different treatment options that are available to workers with a back injury have     often led to confusion and frustration. New back pain research has shown which combinations     of treatments are most helpful, but has also shown that many injured workers in British     Columbia do not have these treatments made readily available to them. This research study is     designed to accurately determine whether or not providing patients suffering from acute back     injuries with a combination of all of these recommended treatments, will improve their     function, quality of life and return to work.   "
175944|NCT00143325|"     Open-label comparison of standard 12-week regimen of varenicline with standard 10-week     regimen of transdermal nicotine patch for smoking cessation.   "
175772|NCT00135252|"     Infants of < 1500 grams of birth weight who require a > 1 week mechanical ventilation     (breathing machine) or CPAP [continuous positive airway pressure] (oxygen at a high flow     through the nose) may have prolonged oxygen requirements. The nasal cannula (oxygen through     the nose at a low flow) is the most commonly used method of oxygen administration, despite a     lack of data regarding its safety and efficacy. Low birth weight infants are vulnerable to     obstruction from secretions and blood, as well as the presence of the nasal cannula.     Partially obstructed nostrils greatly increase the work of breathing. Additional potential     adverse effects include an increased need for suctioning, increased risk for systemic     infection, and inadvertent positive end expiratory pressure (CPAP). No study has been     conducted to evaluate the efficacy of the nasal cannula compared to an oxygen hood (plastic     hood that is placed over the infant's head to provide oxygen) on gas exchange or infection.      Among infants who require supplemental oxygen (by either a nasal cannula or an oxygen hood)     for clinical indications, objectives the investigators hope to accomplish in a randomized     blinded (investigator) trial:      Aim 1: To determine the short-term effect of different flows of oxygen by the nasal cannula     on transcutaneous PCO2 (PTCO2).      Aim 2: To determine, once optimal flow is established in Aim 1, the effect of prolonged (one     week) use of a nasal cannula compared to an oxygen hood on PTCO2.   "
175773|NCT00135265|"     This is a pilot study addressing office systems and clinician behavior change surrounding     smoking cessation interventions for teens. The investigators' long-term goal is to improve     the quality of clinical preventive services in practice-based research network settings.     Their specific aims are to:        -  a) pilot procedures for recruitment and randomization of PROS practices; and b) field          trial/pilot PROS practitioner cessation counseling and practices' enrollment of          adolescent patients; and        -  assess the feasibility of pediatric clinician referral of adolescent patients to          internet-based adjuncts for smoking cessation.      The investigators will evaluate a pilot round of recruitment and randomization, and smoking     cessation training and delivery in 10 PROS practice sites; and assess the acceptability of     study procedures and on-line internet counseling adjunct referral feasibility within PROS     practice sites. Up to 1000 adolescents presenting for well visits will complete a short     baseline survey prior to their well-visit. A sample of them will be surveyed by phone at 4-6     weeks to provide preliminary estimates of cessation counseling effectiveness for future     studies. The investigators will field test measures, describe the patterns of smoking among     youth, and explore how much receiving interventions affects motivation, quitting,     abstinence/relapse attitudes, attitudes towards internet-based outreach strategies, and     behaviors for 100 smokers.      **we have completed recruitment of providers; we are recruiting teens ONLY at this point**   "
175774|NCT00135278|"     The overall purpose of this pilot study is to evaluate CSF drainage as a potential     neuroprotective strategy after acute spinal cord injury (SCI).   "
175775|NCT00135291|"     The purpose of this study is to determine if leukoreduced blood transfusions reduce the risk     of infection following trauma. Specifically, the investigators intend to evaluate whether     there are clinically relevant differences in the rates of infection and in the severity of     multiple organ failure in critically injured trauma patients receiving leukoreduced blood     products compared to those receiving standard allogeneic blood products.   "
175776|NCT00135304|"     The purpose of this study is to compare the proportion of chronic kidney disease (CKD)     subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of     vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease     Outcomes Quality Initiative (NKF-K/DOQI) secondary hyperparathyroidism (HPT) treatment     targets for both biointact parathyroid hormone (biPTH) and calcium-phosphorus (Ca x P)     product.   "
175777|NCT00135317|"     The study is designed to assess if the addition of intravenous (IV) iron to 500 mcg every 3     week (Q3W) darbepoetin alfa treatment enhances response as compared to the standard practice     (oral iron or no iron administration).   "
175778|NCT00135330|"     This protocol is designed to evaluate the metabolic effects of adding exenatide,     rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate     glycemic control.   "
175779|NCT00135343|"     The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside     sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of     atazanavir.   "
175780|NCT00135356|"     The purpose of this clinical research study is to learn if human immunodeficiency virus     (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral     treatment (HAART) regimen have better changes in fat distribution after switching to     atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART     regimen.   "
175781|NCT00135369|"     The purpose of this study is to demonstrate that virologically controlled HIV-infected     individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more     frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as     evaluated by the proportion of subjects who continue to have plasma HIV-1 levels <50     copies/mL after switching to a QD regimen.   "
175782|NCT00135382|"     The purpose of this study is to demonstrate that virologically controlled HIV-infected     individuals can successfully switch from a protease inhibitor (PI)-based regimen to an     efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion     of subjects who continue to have plasma HIV-1 levels < 50 copies/mL. In addition, a     simplified once-daily regimen will improve adherence and quality of life.   "
175783|NCT00135395|"     The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum     lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1     infected subjects who have experienced their first virologic failure while receiving a     NNRTI-containing HAART regimen.   "
175784|NCT00135408|"     The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010     (BMS-734016) administered with or without Prophylactic Oral Budesonide.   "
175785|NCT00135421|"     The purpose of this clinical research study is to learn whether BMS-562086 is both safe and     effective in treating outpatients with major depressive disorder.   "
175786|NCT00135434|"     This study examined the effects of two commonly prescribed HIV drugs on the way the body     metabolizes glucose, insulin and fat.   "
175945|NCT00143338|"     To examine the lung when people with diabetes take an inhaled form of insulin, compared to     subcutaneous insulin.   "
175788|NCT00135460|"     Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV     infected individuals. However an increasing number of HIV-patients have developed metabolic     and morphological alterations including peripheral lipoatrophy.      There is limited knowledge about lipodystrophic adverse events in nucleoside reverse     transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues     are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing     regimen will have little risk of peripheral lipoatrophy.      The researchers plan to perform a randomized study recruiting 100 antiretroviral naive     patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a     protease-inhibitor sparing regimen.      The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray     absortiometry (DEXA)-scanning.   "
175789|NCT00135473|"     The purpose of this trial is to determine the influence of colloid versus crystalloid volume     resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of     patients with severe sepsis and septic shock.   "
175793|NCT00135525|"     This study is designed to evaluate the efficacy and safety in Generalized Anxiety Disorder     patients   "
175794|NCT00135538|"     The purpose of this study is to investigate whether noninvasive ventilation by nose mask     during the night has additional benefits next to pulmonary rehabilitation in patients with     severe hypercapnic COPD.   "
175795|NCT00135551|"     A number of major clinical trials have demonstrated the clinical benefits of lowering blood     pressure and have indicated that a majority of patients with hypertension will require more     than one drug to achieve optimal blood pressure control.      There is little data showing which antihypertensive combination best protects patients from     cardiovascular events and which best achieves the target blood pressure with the fewest     adverse events.      The COPE trial is planned to investigate, in patients with hypertension, which combination of     the antihypertensive drugs, angiotensin receptor blockers, β-blockers or thiazide diuretics     in addition to a long-acting calcium antagonist, benidipine hydrochloride, is superior to     achieve the targeted blood pressure and prevent cardiovascular events with the fewest adverse     drug effects.   "
175796|NCT00135564|"     The purpose of this booster vaccination study is to evaluate the persistence and immune     memory induced by a three-dose primary vaccination course with GSK Biologicals' MenC-TT     (Neisseria meningitidis group C polysaccharide-tetanus toxoid) and GSK Biologicals'     Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) or Meningitec™ vaccines in healthy     toddlers aged 12-15 months by giving them a 1/5th dose of Mencevax™ ACWY.   "
175797|NCT00135577|"     Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of     multiple dosage regimens of an investigational drug for the treatment of constipation due to     prescription pain medication in participants with cancer pain.      Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access     to blinded investigational product to participants who have completed the original study. The     purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to     placebo in subjects who completed Study SB-767905/008 and elected to participate in this     extension study.   "
175798|NCT00135590|"     The researchers tested the hypothesis that a protein pulse-feeding pattern was more efficient     in improving muscle mass and immune functions than was a protein spread-feeding pattern,     after 45 days, in elderly malnourished patients.   "
175799|NCT00135603|"     The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective     as appendectomy for the treatment of acute non complicated appendicitis. Two hundred fifty     patients will be included in a prospective multicentric randomized trial. The primary     endpoint is the rate of intra abdominal infections in both therapeutic strategies. Other     criteria will be studied including duration of hospital stay and absence from work during a     follow up period of one year, parietal and abdominal complications and recurrent appendicitis     after antibiotic therapy.   "
175800|NCT00135616|"     The purpose of this study is to compare efficacy and morbidity following the placement of two     types of suburethral slings in women presenting with stress urinary incontinence: TVT and     TVT-O.   "
175801|NCT00135629|"     The purpose of this study is to determine at which point in the dosing regime grass pollen     immunotherapy causes a significant reduction in the late skin response to allergen challenge.     A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing     phase, followed by monthly maintenance injections of 100,000 SQ units. Symptom scores and     need of rescue medication were recorded by patients during the study period. The size of     early and late cutaneous response to allergen challenge was recorded and measured by a     physician.   "
175802|NCT00135642|"     The purpose of this study was to assess the effects of grass pollen immunotherapy on     symptoms, bronchial hyperresponsiveness and quality of life in seasonal rhinitis and asthma.     Hay fever symptoms and medication use, health-related quality of life, and measurements of     non-specific bronchial responsiveness were recorded during the study period.   "
175803|NCT00135655|"     The purpose of this study is to investigate the safety and tolerability of three dose     strengths of the study drug in subjects with post cataract extraction macular edema.   "
175804|NCT00135668|"     Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet     there are no controlled studies in children. The purpose of this study is to determine the     efficacy and safety of sodium nitroprusside in children who will be having surgery, and who     require blood pressure lowering in order to decrease the amount of blood loss during their     surgery.   "
175805|NCT00135681|"     To immunize both normal and asthmatic subjects with a neoantigen, keyhole limpet hemocyanin     (KLH) and observe the type of antibody and T cell response that develops.   "
175816|NCT00135824|"     Instillation of artificial tears is standard treatment in dry eye syndrome and in patients     experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone)     is an isotonic solution containing povidone to simulate normal tears viscosity. Safety and     local tolerability of Povidone K25 is evaluated in healthy volunteers in comparison to     placebo eye drops.   "
175817|NCT00135837|"     Age related macular degeneration is the leading cause of blindness for people over 50 in the     western world. Blood vessels which start to grow form a lesion in the back of the eye.     Verteporfin may stabilize the disease, by closing the blood vessels. This study will assess     the efficacy and safety of verteporfin in patients with occult only lesions.   "
175806|NCT00135694|"     In order to prevent organ rejection, patients receiving liver transplants currently require     life-long treatment with immune system-suppressing medications to prevent the rejection of     the transplanted liver. However, these medications can cause long-term side effects, such as     infection, kidney problems, diabetes, and cancer. In patients infected with hepatitis C virus     (HCV), these medications may increase the risk of HCV infection in the transplanted liver.     The purpose of this study is to determine whether a slow withdrawal of immune     system-suppressing medications is safe in two groups of subjects: those who receive a liver     transplant due to HCV, and those who receive a liver transplant due to non-immune, non-viral     causes of liver failure. The study will also look at whether slow withdrawal will help reduce     the long-term side effects of immune system-suppressing medications and decrease the chance     for HCV infection of the new liver in transplant patients with HCV.   "
175821|NCT00135889|"     The purpose of this study is to determine if putting local anesthetic—or numbing     medication—through a tiny tube next to the nerves that go to the knee will improve pain     control during physical therapy, and ultimately improve the results of surgery. It will also     determine if patients having knee replacement surgery may receive the same or better pain     control at home compared with staying in the hospital, and if this improves their experience     following surgery.   "
175874|NCT00136591|"     This is a prospective, randomized, sequential, international, multicentric, 2-arm,     non-comparative, open-label, 2-stage clinical study to determine disease response rates to     Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma.      Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing     convenience will be made in order to recommend a dose schedule for further clinical study.   "
175807|NCT00135707|"     Preeclampsia is one of the most common complications of pregnancy and is characterized by     high blood pressure and protein in the urine. This can cause problems in the second half of     pregnancy for both the mother and fetus. This study of preeclampsia consists of two parts: 1)     a randomized, placebo controlled, multicenter clinical trial of 10,000 low-risk nulliparous     women between 9 and 16 weeks gestation and 2) an observational, cohort study of 4,000     patients between 9 and 12 weeks gestation who are also enrolled in the trial.      Subjects in both parts will receive either 1000 mg of vitamin C and 400 IU of vitamin E or     matching placebo daily. The purpose of the randomized, clinical trial is to find out if high     doses of vitamin C and E will reduce the risk of preeclampsia and other problems associated     with the disease. The study will also evaluate the safety of antioxidant therapy for mother     and infant. Patients will be seen monthly to receive their supply of study drug, to have     weight and blood pressure recorded, to have urine protein measured, and to assess any side     effects. At two visits, blood and urine will be collected.      The observational, cohort study will prospectively measure potential biochemical and     biophysical markers that might predict preeclampsia. These patients will have additional     procedures including uterine artery Doppler and blood drawn for a complete blood count (CBC).   "
175808|NCT00135720|"     The purpose of the study is to find out about the effectiveness and the safety of an     investigational drug called etanercept (Enbrel) to treat pemphigus vulgaris. Pemphigus     vulgaris is a potentially life threatening blistering condition that currently has no cure.      An investigational drug is one that has not been approved by the United States (US) Food and     Drug Administration (FDA) to treat a particular condition or disease. Etanercept has been     approved by the FDA to treat rheumatoid arthritis, juvenile rheumatoid arthritis, and     psoriasis, but not pemphigus vulgaris.   "
175809|NCT00135733|"     The purpose of this study is to find out how safe and effective an investigational drug     called alefacept (amevive) is for the treatment of moderate to severe erosive mucosal lichen     planus.      Lichen planus is a skin disease that can last a long time and cause significant pain,     itching, and scarring. It can affect the mucous membranes (area inside the mouth and vagina)     and these areas can become erosive (sores can develop). Currently there is no known cure for     this disease.      An investigational drug is one that has not been approved by the United States (US) Food and     Drug Administration (FDA) to treat a particular condition or disease. Alefacept has been     approved to treat psoriasis (a scaly skin rash). A number of reports suggest that lichen     planus develops for some of the same reasons as psoriasis, but alefacept is not yet approved     for the treatment of psoriasis.   "
175810|NCT00135746|"     Treatment studies have demonstrated that current smoking cessation techniques are less     effective for women. The purpose of this study is to determine the role that gender plays on     the effectiveness of nicotine replacement therapy. This may lead to improved cessation     interventions for all smokers, particularly women.   "
175811|NCT00135759|"     There is a continuing search for more effective opiate detoxification treatments. This     study's purpose is to investigate the effects of adding very low doses of naltrexone to a     methadone tapering treatment in opioid dependent individuals.   "
175812|NCT00135772|"     Nicotine dependence is very common among individuals with schizophrenia and schizoaffective     disorder. Cotinine is a chemical that is made by the body from nicotine. Measuring levels of     nicotine and cotinine is an accurate way to determine how much cigarette smoke enters a     person's body. The purpose of this study is to measure nicotine and cotinine levels in     smokers with schizophrenia or schizoaffective disorder to determine if such individuals     absorb more nicotine per cigarette than smokers without schizophrenia-related disorders.   "
175813|NCT00135785|"     Methamphetamine is an addictive stimulant drug that strongly activates certain parts of the     brain. The purpose of this study is to determine the effectiveness of bupropion in     combination with behavioral therapy for the treatment of methamphetamine addiction.   "
175814|NCT00135798|"     The purpose of this study is to learn if pre-liver transplant treatment, using peginterferon     plus ribavirin, will clear hepatitis C virus (HCV) RNA from the blood in HCV-infected     recipients and reduce the risk of recurrent HCV and allograft hepatitis following liver     transplant.   "
175815|NCT00135811|"     The FSGS Clinical Trial is a multi-center, prospective, controlled, open label randomized     trial designed to determine if treatment with mycophenolate mofetil (MMF) in conjunction with     pulse steroids is superior to treatment with Cyclosporine-A (CSA) in inducing remission from     proteinuria over 12 months.   "
175864|NCT00136461|"     The purpose of this study is to assess the effects of the combination of all-trans retinoic     acid in combination with one of two schedules of Bryostatin 1 in patients with myelodysplasia     and acute myelogenous leukemia.   "
175818|NCT00135850|"     The aim of this study was to evaluate the mobilization of non-haematopoietic mesenchymal and     haematopoietic stem cells from the bone marrow with granulocyte colony stimulating factor     (G-CSF) treatment alone and in combination with vascular endothelial growth factor (VEGF)     gene therapy in patients with severe chronic occlusive coronary artery disease.   "
175819|NCT00135863|"     Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R)     (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the     morning dialysis bag. Active medication, as well as placebo, was added for three months     separated by a one month washout period. At the beginning and end of each treatment period     peritoneal equilibrations tests (PE-tests), Kt/V, blood and dialysate samples were analyzed.     We, the researchers at Ribe County Hospital, set out to examine inflammation (local and     systemic), nutrition and ultrafiltration.   "
175820|NCT00135876|"     In patients with malignant glioma, to determine the efficacy of prophylaxis with LMWH     (dalteparin) compared to placebo, both commenced beyond the immediate postoperative period,     for the prevention of VTE.   "
175822|NCT00135902|"     A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate     (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However,     the group who received 17P in this trial still had a high rate of preterm birth. Several     reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty     acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3     supplement to 17P therapy has the potential for further reducing the risk of preterm birth in     women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3     fatty acid with placebo in women receiving 17P therapy. The hypothesis being tested is:     Among women at high risk for preterm birth receiving weekly injections of 17P, the addition     of Omega-3 nutritional supplement will further reduce the rate of preterm birth.   "
175823|NCT00135915|"     Although there is no evidence that individuals with type 1 diabetes have a different approach     to alcohol compared to the background population, nevertheless, its use does have     implications for patients mainly because of the risk of hypoglycaemia unawareness. However,     binge drinking has been implicated as a factor in the development of ketoacidosis and is     probably under-recognised. The aim of this study is to examine the effect of binge drinking     on glucose, insulin, counter-regulatory hormones and other metabolites in patients with type     1 diabetes. It is hoped that data from this project will be used to develop a larger study     comparing different treatment regimens for patients using alcohol to reduce the risks of     hyperglycaemia as well as hypoglycaemia.   "
175824|NCT00135928|"     The purpose of this trial is to investigate the effect of treatment with granulocyte-colony     stimulating factor (G-CSF) bone marrow stimulation on circulating stem cells' ability to     develop new blood vessels in the myocardium after an acute myocardial infarction.   "
175825|NCT00135941|"     The purpose of this study is to test for superiority in improvements from baseline in patient     reported outcomes in subjects with type 1 or type 2 diabetes when treated with insulin     glargine plus rapid acting insulin glulisine MDI versus treatment with premix insulin.   "
175826|NCT00135954|"     Patients with idiopathic membranous nephropathy at risk for renal failure can be identified     in an early stage by measuring urinary low molecular weight proteins and urinary     immunoglobulin G (IgG). This study evaluates the possible benefit of early start of     immunosuppressive therapy in these high-risk patients.   "
175827|NCT00135967|"     Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for     end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a     treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side     effects.      In this pilot study patients with membranous nephropathy and renal failure will be treated     with mycophenolate mofetil and prednisone. The outcome will be compared with historical     controls treated with a similar regimen containing cyclophosphamide.   "
175828|NCT00135980|"     The purpose of this study is to compose, implement and evaluate a programme to improve the     quality of integrated care for patients with cancer.      Literature will be searched for components of integrated care programmes. On the basis of     evidence based multi-disciplinary guidelines and literature on integrated care programmes, a     set of indicators will be composed. This set will be measured in 6 hospitals on patients with     non-small-cell-lung cancer. In two hospitals, an integrated care programme will be     implemented and effects on processes and outcomes of care will be measured.   "
175829|NCT00135993|"     Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4     cardinal clinical features according to the International Restless Legs Syndrome Study Group     (IRLSSG) are allowed to enroll in this trial.      The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is     efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to     investigate the safety and tolerability of rotigotine.      Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day     rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be     enrolled in this trial, participating at approximately 60 sites. The maximum duration of the     trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month     Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).   "
175830|NCT00136006|"     This is a study of the lung health of the population of Vancouver and the extent of, and the     risk factors for, chronic obstructive lung disease.   "
175831|NCT00136019|"     Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with     partial seizures and are taking up to 3 medications for this medical condition will take part     in a research study at approximately 85 different locations in the United States.      The purpose of the study is to evaluate the effectiveness, safety and tolerability of     consistent dosages of a study drug (lacosamide [SPM 927]) taken orally twice a day for about     five months.      Each patient who qualifies and chooses to participate in the study will receive placebo     (inactive drug) or gradually increasing doses of lacosamide up to the target dose of     400mg/day or 600mg/day. The target dose or placebo will be maintained for 12 weeks.      The study clinic visits will include a medical history and physical exam, electrocardiogram     (ECG), blood and urine sample collection, and completion of a seizure diary.      Patients who complete the study may enroll in an extension trial and receive active study     drug.   "
175832|NCT00136032|"     The purpose of the study is to evaluate the effects of growth hormone replacement on women     with growth hormone deficiency. Growth hormone deficiency means the body no longer produces     growth hormone due to a tumor or some kind of disease of the brain in an area called the     pituitary/hypothalamic region. This is the area of the brain where growth hormone is normally     produced. We, the researchers at Massachusetts General Hospital, will establish the effects     of growth hormone replacement on cardiovascular parameters (laboratory tests, the flexibility     of the arteries, changes in heart rate) in women with growth hormone deficiency. Our goal is     to see if this therapy:        -  has effects on women's cardiovascular risk markers (special blood tests which indicate          how healthy the heart and arteries are)        -  has effects on women's types and levels of various substances circulating in their blood        -  in women affects the stiffness of their arteries and heart rate variability in parallel          with changes in cardiovascular risk markers        -  has different effects depending on whether women are pre or post menopausal.      Participation in this study is expected to last approximately 12 months.   "
175833|NCT00136045|"     The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is     efficacious in subjects with idiopathic restless leg syndrome (RLS). Additional objectives     are to investigate the safety and tolerability of rotigotine.      The primary variables are the absolute change from Baseline in the International Restless     Legs Severity Scale (IRLS) sum score and Clinical Global Impression-Global Improvement (CGI)     Item 1 (severity of illness) score at the end of the Maintenance Period.      Subjects will be randomized to receive either placebo, 2.25, 4.5 or 6.75 mg/day rotigotine in     a 1:1:1:1 (active:placebo) fashion. Approximately 450 subjects will be enrolled in this     trial, participating at approximately 50 sites. The maximum duration of the trial is     approximately 8 months (3-week Titration Period, 6-month Maintenance Period, 7-day Taper     Period, and 30-day Safety Follow-Up Period). Subjects who complete the 6-month Maintenance     Period will be eligible to participate in an open-label extension trial. Subjects who do not     complete the 6-month Maintenance Period or who choose not to participate in the open-label     extension trial will complete a 3-day Safety Follow-Up Period. Two different patch sizes will     be used (5 and 10 cm2). Active patches will contain either 2.25mg (5cm2) or 4.5mg (10cm2) of     rotigotine.   "
175834|NCT00136058|"     The objective of this study is to determine if an intervention with a fracture manager to     arrange bone densitometry after a hip fracture is more effective in diagnosing and treating     osteoporosis when compared to usual care. Usual care consists of no intervention to     arrange bone mineral density (BMD) testing or therapy other than what normally occurs in the     community. The investigators postulate that a fracture manager will be more effective in     getting BMD done and in starting appropriate therapy.   "
175835|NCT00136071|"     Urinary incontinence (involuntary leakage of urine) is an extremely common, distressing and     socially disabling condition. It is known to affect up to 14 % of the adult female population     in the United Kingdom. Sufferers tend to become social recluses, not wanting to socialise for     fear of embarrassment and ridicule. It typically takes up to 5 years from the onset of     symptoms for a patient to admit their problem, seek help and reach a specialist.     Unfortunately, it is commonest in the elderly when the incidence is as high as 50% in some     studies. Furthermore, this group of patients are the least likely to seek help, the least     likely to receive help and up until recently the least likely to be cured of their problems.      Things are improving however, as everyone is more prepared to talk about this awful condition     rather than accept it as a part of growing old. Furthermore, better treatments are becoming     available which can help the old as well as the young.      Two years ago a new operation for urinary leakage was launched in the United Kingdom (UK).     This is a smaller operation than those previously available and more suitable for the frail     and elderly. We, the researchers at South Glasgow University Hospital, have been using this     operation for 18 months with good success. Several versions however are now on the market,     some much more expensive than the original, and perhaps not as good. We need to know which     one is best and hence we intend to do a study to find out.      We aim to select patients with leakage to have one or the other operation and to follow the     patients over several years to find out which operation is best, safest, lasts longest and is     most acceptable to patients. Only then will we know which of the versions of this procedure     we should be offering our patients.   "
175836|NCT00136084|"     The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy     regimens using different dosages of cytarabine to eliminate all detectable leukemia.   "
175837|NCT00136097|"     This is an evaluation of the use of silver impregnated catheters in burn patients to reduce     catheter colonisation compared to the standard central venous catheter without antiseptic     activity.   "
175838|NCT00136110|"     The purpose of this study is to determine whether the use of sodium valproate is effective in     slowing the disease progression in Amyotrophic Lateral Sclerosis.   "
175839|NCT00136123|"     This study will evaluate the placement of implants with minimal invasive techniques.     Immediately after the placement of the implants, functional loaded synthetic teeth will be     placed.   "
175840|NCT00136136|"     This study will evaluate the registration of the bispectral index and spectral edge frequency     in relation to the behavioural state.   "
175841|NCT00136149|"     This is a study to evaluate immediate implants.   "
175842|NCT00136175|"     This trial will evaluate the efficacy and safety of combination chemotherapy (paclitaxel,     carboplatin, and gemcitabine) prior to surgery in the treatment of patients with locally     advanced transitional cell cancer of the bladder.   "
175865|NCT00136474|"     The purpose of this study is determine the effects (good and bad) amifostine has on     radiation-induced side effects of lymphoma treatment.   "
175866|NCT00136487|"     The purpose of this study is to learn the effects (both good and bad) that celecoxib has on     prostate cancer and patients with prostate cancer. This study is looking at what effects     celecoxib has on prostate specific antigen (PSA) level. PSA is a marker specific to prostate     cancer. An increase or decrease in this level in the blood can indicate if a patient's     prostate cancer is getting worse or better.   "
175867|NCT00136500|"     CRiALS is an umbrella protocol through which people are recruited to participate in a range     of research studies being conducted by the ALS Research Collaboration (ARC).   "
175843|NCT00136188|"     Experimental data suggest that oxidative stress and endothelial dysfunction are key players     in the pathogenesis of diabetic nephropathy. In the last few years the investigators were     able to establish a method to assess endothelial function of the renal vasculature in humans     and started to systematically study a variety of cardiovascular disorders known to be     associated with endothelial dysfunction in other vascular beds, including hypertension,     hypercholesterolemia and type-2 diabetes. In patients with type-2 diabetes the investigators     could demonstrate that despite unaltered basal and stimulated NO-activity, the renal response     to the antioxidant vitamin C was more pronounced compared to control subjects. These data     suggest that oxidative stress is increased in the renal vasculature of diabetic patients.     Furthermore, NO-activity in diabetic patients appears to be upregulated to compensate for the     increase in oxidative stress. This hypothesis is supported by the demonstration of increased     endothelial nitric oxide synthase (eNOS) expression in kidney biopsies of diabetic patients.      The major focus of the investigators' current research activities is to assess the role of     endothelial dysfunction in the very early stages of diabetic nephropathy. To this end,     patients with increased fasting glucose or metabolic syndrome will be studied in comparison     with an age-matched control group. Endothelial function and the role of oxidative stress will     be assessed in the renal vasculature in all groups. In parallel, the investigators will study     endothelial function in the forearm by venous occlusion plethysmography and in the retinal     vasculature by scanning laser doppler flowmetry to dissect regional differences in the     regulation of endothelial function. Further aspects include the role of microalbuminuria,     glomerular hyperfiltration, and endogenous inhibitors of NO synthase such as     NG,NG-Dimethyl-L-Arginine (ADMA). In a therapeutic approach, the investigators will determine     the effects of various antioxidant treatment strategies on endothelial function and their     potential role in the prevention of diabetic nephropathy.   "
175844|NCT00136201|"     The primary objective of this study is to compare the safety and efficacy of an experimental     antibiotic to a marketed antibiotic in the treatment of Chinese subjects with complicated     intra-abdominal infections. <br />   "
175845|NCT00136214|"     The hypothesis of this study is that pegylated interferon would cause cognitive deficits and     mood changes in hepatitis C (HCV) positive subjects.   "
175872|NCT00136565|"     The purpose of this study is to determine the efficacy and the safety profile and toxicity of     a combination of Velcade™ (bortezomib) with a standard chemotherapy regimen (ACVBP     [doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone]) in the treatment of     previously untreated patients with peripheral T-cell lymphoma (PTCL).   "
175846|NCT00136227|"     During this first year, the researchers have worked toward identifying factors influencing     initiation of colorectal cancer screening among Hispanic men and women aged 50 and older and     developing an intervention plan using Intervention Mapping, a framework for systematic health     promotion program planning, implementation, and evaluation. The researchers are also     currently in the preliminary stages of developing two promotora (lay health worker)-delivered     interventions: a small media intervention (video, flip chart, pamphlets) and a tailored     interactive multimedia intervention, prior to the actual collection of data. Thus, although     733 subjects have been approved by the Committee for the Protection of Human Subjects to be     enrolled in this study in the future, no subjects have been enrolled at this time.     Consequently, there have been no adverse events, and since the risks associated with     participating in this study are negligible, the researchers do not anticipate any adverse     events in the future. No modifications have been made to the research since the last review,     other than that the researchers are currently reassessing the need to conduct preliminary     qualitative research as proposed in the original protocol.   "
175847|NCT00136240|"     This study will determine the efficacy of a computerized telephone system called     Telephone-Linked Care (TLC) in improving adherence to antidepressant medication regimens in     people with depression.   "
175848|NCT00136253|"     American hemodialysis patients are frequently malnourished. This contributes to dialysis     patient mortality rates that are the highest in the industrialized world at 22% per year.     Poor nutritional status probably also contributes to high health care costs (an average of     two hospitalizations annually per patient and total Medicare expenditures of $11 billion per     year) and diminished quality of life. The researchers' prior work identified several     potentially modifiable nutritional barriers (e.g. poor appetite, inadequate dialysis dose,     poor nutritional knowledge, low fluid intake, and needing help shopping and cooking) and     pilot tested a promising approach to overcome these barriers.      This proposed community-based randomized controlled trial extends the researchers' prior work     by targeting specific nutritional barriers with a tailored feedback and education     intervention. Approximately 40 dialysis facilities in northeast Ohio will be randomly     assigned to intervention and control groups, with approximately 100 malnourished patients     enrolled from 20 intervention facilities and 100 from 20 control facilities. Baseline     evaluation will include measures of nutritional status, specific barriers, inpatient     expenditures, and quality of life. On a monthly basis for 12 months, intervention patients     and their dietitians will receive tailored feedback and education on overcoming     patient-specific barriers. They will then meet monthly to jointly formulate a care plan     addressing these barriers. Control patients will continue to get usual care. Major analyses     will compare changes in nutritional parameters in intervention vs. control patients with     adjustment for nesting of patients within facilities.      The proposed project will test a novel intervention that targets patients and providers as     they together make nutrition-related decisions. Overcoming specific barriers may lead not     only to improved nutritional status but also to better patient survival, decreased health     care costs, and increased quality of life.   "
175849|NCT00136266|"     Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children     beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron     deficiency.   "
175850|NCT00136279|"     The purpose of this study is to develop and evaluate the effectiveness of a parent-based     intervention that can be implemented in conjunction with existing school-based programs     designed to prevent or reduce sexual risk behavior or to prevent or reduce tobacco use in     young adolescents. The parent programs are expected to have effects on adolescent behavior     over and above the effects of the school-based programs.   "
175851|NCT00136292|"     The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin     in patients aged 2-17 years old who have a suspected or proven gram-positive infection for     which they are receiving standard antibiotic therapy. The tolerability of a single dose of     daptomycin in these patients will also be assessed.   "
175852|NCT00136305|"     The purpose of this study is to evaluate and compare the relative effectiveness of two asthma     action plans (pictorial versus written) in terms of asthma action plan knowledge, medication     use, and family satisfaction with asthma education.   "
175868|NCT00136513|"     The purpose of this study is to find a dose of SB-743921 in adult patients with solid tumors     or lymphoma who have progressed on standard therapy or who have relapsed. SB-743921 is dosed     by 1-hour intravenous infusion every 3 weeks. A patient may continue to receive treatment as     long as they are benefiting from the treatment. Blood samples will be taken at specific times     to measure the amount of the drug in your body at specific times after the drug is given.     Blood samples will also be taken for lab tests such as complete blood counts and clinical     chemistries. Physical exams will be performed before each treatment with SB-743921. During     the treatment phase, the patients will undergo regular assessments for safety and clinical     response.   "
176013|NCT00144287|"     This study evaluated the safety and tolerability of tipranavir to improve treatment options     for HIV type 1-infected patients who have been previously treated and whose treatment is no     longer effective.   "
175853|NCT00136318|"     Primary end points        -  incidence of depression defined as a Montgomery Asberg Depression Scale Score (MADRS) of          13 or higher during antiviral therapy (up to 48 weeks, depending on genotype)        -  effect of an antidepressive pre-treatment over two weeks and a continuously concomitant          treatment with Escitalopram (S-citalopram) on frequency and severity of depression in          patients with chronic hepatitis C (HCV) treated with Peg-interferon alfa-2a (PEGASYS)          and ribavirin, measured by the Montgomery Asberg Depression Scale      Secondary end points        -  time to depression defined as a MADRS score of 13 or higher        -  incidence of major depression defined by Diagnostic and Statistical Manual IV (DSM-IV)          criteria        -  severe depression according to MADRS scale (score 25 or higher)        -  Health related quality of life (HRQOL) measured by the Short Form 36 (SF-36)        -  sustained virologic response        -  tolerability        -  safety        -  changes/group differences in other psychiatric depression scales (Hamilton Depression          Rating Scale, Beck Depression Inventory)      Other investigations:        -  cognitive function, anxiety (word fluency test, trail making test part A and B, othe          scales)        -  Predictive parameters for patients especially gaining from an antidepressive therapy          (e.g. age, gender, weight, height, alanine aminotransferase (ALAT) quotient defined as          median ALAT values before treatment divided by the upper standard value, HCV-RNA serum          concentration level of fibrosis in liver histology, baseline values of the different          psychometric scales)        -  alanine aminotransferase (ALAT), aspartate transaminase (ASAT), thyrotrophin (TSH)        -  biomarkers (genetic parameters, cytokines,...)   "
175854|NCT00136331|"     The World Health Organisation has warned that an influenza pandemic is inevitable. The avian     influenza H5N1 virus strain is the leading candidate to cause the next avian influenza     pandemic. This study will test the safety and immunogenicity of a H5N1 pandemic influenza     vaccine in healthy adults.   "
175873|NCT00136578|"     The purpose of this study is to determine the dose regimen of Ispinesib in combination with     carboplatin in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion     and carboplatin is dosed by 30 minute intravenous infusion every 3 weeks (on the same day). A     patient may continue to receive treatment as long as they are benefiting from the treatment.     Blood samples will be taken at specific times to measure the amount of both drugs in your     body at specific times after the drug is given. Blood samples will also be taken for lab     tests such as complete blood counts and clinical chemistries. Physical exams will be     performed before each treatment with Ispinesib. During the treatment phase, the patients will     undergo regular assessments for safety and clinical response.   "
175924|NCT00143065|"     This purpose of this study is to assess the toxicity and the rate of complete and overall     response using fludarabine, rituximab, and alemtuzumab to treat patients with B-chronic     lymphocytic leukemia or small lymphocytic leukemia who have received previous treatment.   "
175855|NCT00136344|"     Cataract is the most important cause of visual impairment and decreased mobility in the     elderly. While surgery is usually successful, it is also responsible for permanent loss of     vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis).     Because of this risk, surgery is typically performed on one eye at a time leaving the patient     with a monocular cataract causing considerable visual impairment with reduction in mobility     and quality of life. A second operation is required which often takes place up to one year     later.      It is not known at present whether the post-operative complication of endophthalmitis can be     prevented by perioperative use of antibiotics. This randomised study (masked and     placebo-controlled for topical levofloxacin and unmasked for intracameral injection of     cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either     topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection     of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the     combination provides effective prophylaxis of post-operative infection (endophthalmitis)     compared to controls in whom perioperative antibiotics are not used. The result will provide     a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery     in Europe as well as an accurate figure for the incidence of endophthalmitis following     phacoemulsification cataract surgery in Europe for the first time.   "
175856|NCT00136357|"     The purpose of this study is to determine whether the participation in a group program which     includes meditation, biofeedback, drawings, autogenic training, genograms, and a variety of     movement and breathing techniques will decrease symptoms of posttraumatic stress in high     school students.   "
175857|NCT00136370|"     The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine     administered to the birth canal during labour and newborn at delivery can protect a woman and     her baby from bacterial infections after birth. If effective, this could be used as an     inexpensive alternative to antibiotics to prevent newborn infections in resource-poor     countries.   "
175858|NCT00136383|"     This double-blind placebo-controlled trial is designed to test and to compare the     cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients     with depressive symptoms.   "
175859|NCT00136396|"     The purpose of this study is to determine if rituximab is a safe and effective therapy for     steroid-refractory chronic graft versus host disease (GVHD).   "
175860|NCT00136409|"     The purpose of this study is to determine the effects (good and bad) of Gleevec in patients     with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid     metaplasia and chronic myelomonocytic leukemia.   "
175861|NCT00136422|"     The purpose of this study is to test the safety of a new investigational acute myeloblastic     leukemia (AML) vaccine and see what effects (good and bad) it has on patients with advanced     myelodysplasia or acute myelogenous leukemia.   "
175862|NCT00136435|"     The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in     adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.   "
175863|NCT00136448|"     This study will add interleukin-2 (IL-2) to a regimen of post-remission therapy consisting of     high-dose ara-C. Patients with AML in first remission will receive 3 cycles of high-dose     ara-C followed by continuous infusion and bolus interleukin-2 (IL-2). We, the researchers at     the Dana-Farber Cancer Institute, plan to evaluate the immunologic effects of such treatment     in these patients.   "
175869|NCT00136526|"     This study is for men who have prostate cancer that has spread outside of the prostate gland     and is no longer responding to hormone removal therapy. This study is designed to determine     if a new drug combination will help to control the cancer. The medicines being used,     docetaxel and diethylstilbestrol (DES), have been given to patients with prostate cancer and     each drug has demonstrated activity in prostate cancer, either used alone or in other     combinations. The objective of this study is to determine the effect of this drug combination     on the prostate cancer and its response to disease progression.   "
175870|NCT00136539|"     The purpose of this study is to determine the effectiveness and safety of administering     Herceptin in combination with Taxol (paclitaxel) in the treatment of women with     HER2-positive, early stage breast cancer prior to surgery.   "
175871|NCT00136552|"     The purpose of this study is to assess in a prospective multicentric study (Phase III) the     introduction of a monoclonal antibody directed against B-cells associated with a standard     therapy including chemotherapy and alpha-interferon in first line treatment of patients with     a large tumor burden follicular lymphoma.   "
175950|NCT00143455|"     To compare the effects of irinotecan hydrochloride with cisplatin to the standard regimen     etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly     diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).   "
175875|NCT00136604|"     The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a     booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15     to 24 months of age primed with 3 doses of Tritanrix™-HepB/Hib-MenAC in study 100480.     Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and     reactogenicity of a dose of Mencevax™ ACWY given at 24 to 30 months will also be evaluated     when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.   "
175876|NCT00136617|"     The purpose of this study is to compare a fixed-schedule therapy versus a symptom-triggered     therapy for alcohol withdrawal syndrome in medical outpatients.      Objectives:        -  Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication        -  Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal          syndrome        -  Outpatient treatment of alcohol withdrawal syndrome   "
175877|NCT00136630|"     The autosomal dominant spinocerebellar degenerations are a highly heterogeneous, clinically     and genetically, group of rare diseases and of severe evolution. So far, the responsible     genes for less than 50% of the cases are known and because of their rarity, there are no     phenotype-genotype correlations and well-defined disease history.      The aims of the project are to develop and validate quantitative tools of the cerebellar     syndrome and of the spasticity, to establish links between the phenotype and the result of     the molecular analysis, to identify new loci/genes responsible for these disorders, and to     establish the natural history of the disease according to the genotype.      To this end, a prospective and multicentric study is proposed for recruiting and evaluating,     clinically, a cohort of 225 patients; 150 of them are already followed-up in the centers     involved. A DNA collection will be set up in order to search for the implication of new loci     and genes. A clinico-genetic database will be set up combining data from successive clinical     evaluations and those of genotyping.      This strategy will allow access to genetic counselling and molecular diagnosis (positive,     presymptomatic or prenatal diagnoses), based on a rational strategy from phenotype-genotype     correlations and the information concerning the relative frequency of the genes. The detailed     description, with the help of new evaluation tools and of the follow-up of the natural     history of the disease according to the genotype, constitutes a crucial step in the design of     therapeutical trials in these orphan disorders. Furthermore, the regular follow-up by     specialized centers will allow better care of the patients.   "
175878|NCT00136643|"     The objectives of this clinical study are to evaluate the extended safety, tolerance and     acceptability of a vaginal gel formulation when applied in 452 healthy women volunteers. This     vaginal formulation was shown to be well tolerated in a previous smaller clinical study. The     formulation is being developed as a microbicide for the prevention of sexually transmitted     infections (STIs) including HIV.   "
175879|NCT00136656|"     The purpose of this study is to demonstrate the equivalence of the therapeutic efficacy of     cefixime by mouth (PO) 10 days (d) and ceftriaxone intravenous route(IV) 4d followed by     cefixime PO 6d on renal scars 6 months after a first acute pyelonephritis episode.      The investigators hypothesize that treatment with cefixime PO will allow no more renal scars     than intravenous route (IV) treatment of pyelonephritis in infants and children less than 3     years old, 6 months after the first episode. If it is true, treatment will no longer need     hospitalisation and the advantages for children, families and the health system will be very     important.   "
175880|NCT00136669|"     Pain is a common problem in patients with pancreatic cancer. Some patients suffer from pain     despite medication. We, the researchers at Memorial Sloan-Kettering Cancer Center, are     conducting a Phase III study to determine the effects of acupuncture on pain in patients with     pancreatic cancer. The purpose of a Phase III study is to determine whether or not a     treatment is helpful. This study will include about 60 patients.      Acupuncture is the insertion of very fine needles into the skin to treat symptoms. In recent     years, researchers have found evidence that acupuncture is useful in treating a variety of     conditions, including headache, nausea, and pain.   "
175893|NCT00136838|"     Recent research on the effects of nicotine on the brain and behavior presents an opportunity     to advance medication development.      The purpose of this study is to develop a laboratory model for early-stage testing of new and     existing treatments for nicotine addiction. Specifically, the investigators will develop a     laboratory model of relapse to cigarette use in nicotine dependent volunteers.   "
175894|NCT00136851|"     This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment     regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.   "
175919|NCT00137176|"     The primary purpose is to determine the changes in gene expression induced by IFNb-1a (Rebif)     and atorvastatin (Lipitor) combination therapy in patients with an isolated clinical syndrome     suggestive of multiple sclerosis (MS), to identify markers of therapeutic response, and to     predict patients' clinical response based on their in vitro response to this combination     therapy measured by the gene expression levels in activated peripheral blood mononuclear     cells (PBMCs).   "
175881|NCT00136682|"     Recovery after major abdominal surgery can be longer than other types of surgery. This is     because often after abdominal surgery, the bowel does not work normally. When this happens,     patients are unable to pass gas. This can lead to bloating, pain, nausea and vomiting. These     symptoms are called postoperative ileus.      We, the researchers at Memorial Sloan-Kettering Cancer Center (MSKCC), are doing this study     to compare two methods of treating pain during and after major gynecological surgery. The two     methods are called patient-controlled epidural analgesia (PCEA) and patient-controlled     intravenous analgesia (PCA). PCA is the standard of care for women having major gynecological     surgery. We are going to compare PCEA to PCA to see if PCEA will improve recovery after major     gynecologic surgery.      PCEA is a well established method used to ease pain in many settings such as during     childbirth and bowel surgery. There have been several studies showing that PCEA is as good as     and sometimes better for pain relief than PCA. PCEA may help the bowel work better by     preventing ileus after surgery. However, this has never been looked at in women having major     gynecologic surgery. This study will also look at whether preventing this ileus will lead to     patients going home or returning to regular activities sooner.   "
175882|NCT00136695|"     The purpose of the study is to assess the effects of sustained aromatase inhibitor therapy to     reduce estrogen levels in elderly men with mild hypogonadism (a decreased level of sex     hormones).   "
175883|NCT00136708|"     In developing countries, neonatal death from birth asphyxia is a major problem. This study     will be conducted in several countries to determine if the combined Neonatal Resuscitation     Program/Essential Newborn Care Program compared to the new World Health Organization (WHO)     basic perinatal care education of health care providers (Essential Newborn Care Program)     results in reduced mortality due to perinatal asphyxia.   "
175951|NCT00143468|"     The investigators aim to study the specific elastance in ALI/ARDS patients during invasive     mechanical ventilation.   "
175952|NCT00143481|"     The purpose of the study is to assess the impact of treatment with tolterodine ER versus     placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.   "
175953|NCT00143494|"     The investigators aim to compare the bladder pressure to the gastric pressure in critically     ill patients.   "
175954|NCT00143507|"     The aim of this study is to test whether ivabradine is able to reduce cardiovascular events     when given to patients with coronary artery disease and impaired heart function.   "
175884|NCT00136721|"     Parkinson's disease (PD) is the most frequent neurodegenerative disease with a prevalence of     2% over 65 years and because of this high prevalence as the population ages, it is a major     problem of public health.      An exhaustive repertory of not only parkin mutations in autosomal recessive forms of PD but     also in other known genes such as DJ-1, PINK1 and LRRK2, is of major importance for both     genetic counseling in families affected with PD and physiopathological approaches to this     disease.      Through a French network for the study of Parkinson's disease genetics and extended     collaborations with European, Mediterranean and other various countries, a total of 2934     subjects including 1683 patients and 1251 unaffected individuals has been collected since     2002. These samples consisted of 122 families with autosomal recessive PD, 285 cases of     isolated early onset PD, 110 autosomal recessive and 129 autosomal dominant families with     late onset PD, 201 isolated late onset PD cases and 250 matched controls.      DNAs from all subjects are now available, lymphocytes and lymphoblastoid cell lines have been     stored for most patients from France and recently, fresh fibroblasts have been obtained for     some individuals.      The genetic approach to autosomal recessive PD is focused on the identification of mutations     in the parkin gene but also on the screening of DJ-1, PINK1 and LRRK2 genes.   "
175885|NCT00136734|"     Many cocaine dependent individuals are also diagnosed with Attention Deficit Hyperactivity     Disorder (ADHD). Methylphenidate (Ritalin) is currently approved to treat individuals     diagnosed with ADHD. The purpose of this study is to determine the effectiveness of     methylphenidate in treating ADHD symptoms in cocaine dependent individuals.   "
175886|NCT00136747|"     One of nicotine's effects on the body is at the level of the NMDA receptors in the brain.     Memantine is a drug that also affects NMDA receptors, making it a candidate for the treatment     of nicotine addiction. The purpose of this study is to evaluate the effectiveness of     memantine using a laboratory model of tobacco addiction. The investigators will compare the     effects of memantine with bupropion, medication currently used to facilitate smoking     cessation.   "
175887|NCT00136760|"     There is a high prevalence of smoking among people with schizophrenia, and there are few     smoking treatment programs for these smokers. The aims of this study are to investigate the     separate and combined effects of bupropion and a voucher incentive program on smoking in     people with schizophrenia.   "
175888|NCT00136773|"     Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk     factor for kidney disease. Aggressive blood pressure reduction is an important strategy to     protect the kidney and reduce urinary protein which develops with kidney disease. This study     will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary     protein in hypertensive subjects with type 2 diabetes mellitus.   "
175889|NCT00136786|"     One of nicotine's effects on the body is at the level of the NMDA receptors in the brain.     Memantine is a drug that also affects NMDA receptors, making it a candidate for the treatment     of nicotine addiction. The purpose of this study is to evaluate the effectiveness of     memantine using a laboratory model of smoking relapse in nicotine dependent volunteers.     Investigators will compare the effects of memantine with bupropion, medication currently used     to facilitate smoking cessation.   "
175890|NCT00136799|"     The purpose of the study is to evaluate the safety and tolerability of fluvastatin 80 mg in a     Chinese population. This study is not recruiting patients in the US.   "
175891|NCT00136812|"     The purpose of this study is to test in a randomized clinical trial a series of hypotheses     concerning the efficacy of an extended expert-system intervention plus nicotine replacement     therapy (NRT) for treating tobacco dependence among patients hospitalized on a smoke-free     psychiatric unit.   "
175892|NCT00136825|"     Recent findings have suggested that N-acetylcysteine (NAC) substantially reduces cocaine     drug-seeking behavior in formerly cocaine dependent rats. The purpose of this study is to     determine the safety, tolerability, and cue reactivity effects of NAC in cocaine dependent     individuals and non-dependent healthy controls.   "
175895|NCT00136864|"     Locally advanced non-small cell lung cancer, NSCLC, (Stage III) is potentially curable with     aggressive combined modality therapy (chemotherapy and radiation). Conventional imaging can     only evaluate gross anatomic abnormalities but functional imaging with positron emission     tomography (PET) may more accurately identify patients who will benefit from aggressive     combined modality therapy.      This prospective randomized clinical trial will enroll 400 patients that have undergone     conventional staging for lung cancer and have been found to have Stage III NSCLC. The     patients will then be randomized to either standard combined modality therapy for Stage III     NSCLC or to PET imaging prior to combined modality therapy with curative intent. Based on the     PET findings, patients will either be suitable for combined modality therapy with curative     intent or not.   "
175896|NCT00136877|"     The purpose of this study is to determine whether tonsillectomy is effective in preventing     further streptococcal pharyngitis episodes in patients with recurrent tonsillitis.   "
175955|NCT00143520|"     This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin     sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not     adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a     placebo and active treatment group for comparison.   "
175956|NCT00143533|"     The primary purpose of this study is to estimate the maximum tolerated dose of irinotecan     with the use of cefpodoxime for pediatric solid tumor patients.   "
176000|NCT00144118|"     The purpose of this study is to determine if isoflurane and sevoflurane have similar effects     on the kidneys of people with impaired kidneys when the drugs administered with low gas flow     into anaesthetic machines.   "
176102|NCT00145457|"     To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1     changes, on the 24 months growth response to 2 different doses of GH in patients with     conventional GH deficiency.   "
175897|NCT00136890|"     Lung cancer remains the leading cause of cancer deaths in men and women. Although overall     survival remains poor, early stage non-small cell lung cancer (NSCLC) is potentially curable.     Improved staging has led to stage-specific therapies such that patients with early stage     NSCLC are potential candidates for surgical resection, and those with more advanced disease     are spared the morbidity and risk of mortality from thoracotomy and pulmonary resection.     Despite contemporary staging techniques, 25-50% of patients who appear to have limited     disease amenable to surgical resection go on to die from metastatic lung cancer. If occult     micro-metastatic disease that becomes evident later could be detected reliably during the     pre-operative assessment, patients harboring such disease could be spared a non-curative     thoracotomy. PET imaging has the potential to detect mediastinal and extrathoracic metastatic     disease not detected by conventional imaging modalities.      This prospective, multicenter trial will enroll patients with biopsy-proven clinical stage     I-IIIA NSCLC who are considered to be candidates for surgical resection with curative intent.     Preoperatively, patients will be randomized to conventional staging for metastatic disease     (CT liver/adrenals, total body bone scan, and CT with contrast or MRI with gadolinium of the     brain) versus whole body PET or PET-CT and brain CT or MRI with contrast/gadolinium.   "
175898|NCT00136903|"     To establish the safety and efficacy of two dose levels of Ex-vivo Cultured Adult     HumanMesenchymal Stem Cells (Prochymal) in subjects experiencing acute GVHD, Grades     II-IV,post HSC transplant.   "
175899|NCT00136916|"     This study is being done to find out the good and bad effects of inhaled insulin that is used     by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name     for this inhaled insulin is Exubera®.      This study included a 2-year comparative treatment period followed by a 6-month follow-up     period during which inhaled insulin-treated subjects were switched back to subcutaneous     short-acting insulin. After this follow-up period, all eligible subjects entered a     comparative extension period that was to last for 5 years. When the comparative portion of     the study was terminated, all subjects were requested to return for a final extension     follow-up month 3 visit.   "
175900|NCT00136929|"     This is a prospective, randomized, multi-center, international trial comparing two     reperfusion strategies in elderly (age >= 70 years) patients with acute myocardial     infarction: primary percutaneous coronary intervention (PCI) versus intravenous thrombolytic     therapy. Clinical endpoints will be collected in the hospital, at 1 month, 6 months, and 1     year post-randomization. The primary endpoint is 30 day death or disabling stroke. The study     null hypothesis is that there will be no significant difference in death or disabling stroke     at 30 days post-randomization between patients treated with PCI versus thrombolytics.   "
175901|NCT00136942|"     The proportion of patients achieving LDL-C target as defined by Swiss cholesterol     recommendations (AGLA-recommendations) across starting doses of 10 mg, 20 mg, 40 mg, and 80     mg of atorvastatin.   "
175902|NCT00136955|"     The purpose of the study is to evaluate the efficacy and safety of Irinotecan plus cisplatin     as first-line chemotherapy for advanced or recurrent cervical cancer   "
175903|NCT00136968|"     The purpose of this study is to determine the amount of voriconazole in the brain by     fluorine-magnetic resonance spectroscopy (MRS) and to compare brain levels to plasma levels.   "
175904|NCT00136981|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      To look at ultrasound images taken in the carotid arteries and to look at various lipids in     the blood of people with heterozygous familial hypercholesterolemia   "
175905|NCT00136994|"     To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with     acute exacerbation of schizophrenia   "
175906|NCT00137007|"     The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is     consistent with current guidelines for the treatment of CAP. In fact the International     guidelines for the treatment of CAP in hospitalised patients suggests the use of a     combination between a b-lactam and a macrolide.      This trial will allow investigators to evaluate the efficacy of azithromycin plus     ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired     pneumonia. In addition, this trial will allow investigators to evaluate the safety and     toleration of combination therapy.   "
175907|NCT00137020|"     The primary objective is to compare effectiveness of ziprasidone treatment to current     treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric     Rating Scale (BPRS) scores versus baseline   "
175908|NCT00137033|"     The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US     setting, using a lower dose of ASA. It is expected that this study will not only confirm the     results of the 258 study but show that the incidence of UGI ulcers on celecoxib is     significantly less than on traditional NSAIDs and the incidence of UGI ulcers on celecoxib     increases with the addition of ASA, but still is lower than traditional NSAIDs plus/minus     ASA. This 7-day study is designed to compare the incidence of gastroduodenal ulcers     associated with celecoxib 200 mg QD and low dose aspirin 81 mg QD and with naproxen 500 mg     BID plus low dose aspirin 81 mg QD in healthy adults(50-75 years of age).   "
175909|NCT00137046|"     This study is being done to find out the good and bad effects of a drug that is not approved     for sale and the effects if any on measures of pulmonary function in adult males and females     with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).      This study included a 2-year comparative treatment period followed by a 6-month follow-up     period during which inhaled insulin-treated subjects were switched back to subcutaneous     short-acting insulin. After this follow-up period, all eligible subjects entered a     comparative extension period that was to last for 5 years. When the comparative portion of     the study was terminated, all subjects were requested to return for a final extension     follow-up month 3 visit.   "
175957|NCT00143546|"     Veno-occlusive disease (VOD) of the liver is a significant complication for some patients     undergoing hematopoietic stem cell transplantation. This disease is thought to be a toxicity     secondary to chemotherapy or radiation-induced damage to the epithelial cells of the blood     vessels in the liver. VOD is categorized as mild, moderate or severe. Historically, there has     been no method to treat the disease. Recently, however, there have been investigations into     the use of a new agent called defibrotide.      The primary purpose of this protocol is to provide defibrotide to patients with severe VOD.     Because this drug has not been approved by the FDA, use of this medication under the auspices     of this IND treatment plan is for compassionate use only.   "
175910|NCT00137059|"     It is widely believed that people who abuse alcohol can sustain a liver injury after taking     doses of acetaminophen just above the recommended maximum dose. This study is designed to     look at the interaction between acetaminophen, liver injury and alcohol abuse. Subjects will     undergo baseline tests to ensure that they do not have liver damage at the time of     enrollment. Each subject will be randomly assigned to receive either a therapeutic dose of     acetaminophen or a placebo three times a day for four days. Subjects will have blood work     drawn on a daily basis to monitor the status of the liver. These tests will include     conventional markers of liver injury in addition to a novel biomarker of liver function,     a-GST. Previous work in the investigators' group has shown that a-GST is a more sensitive     indicator of liver injury following acetaminophen overdose (Sivilotti 1999, Sivilotti 2002 x     2). However, it has never been used to study the alcoholic population. The investigators     believe that a-GST may detect a subclinical acetaminophen-induced liver injury that has     previously gone unrecognized in the alcoholic population.   "
175911|NCT00137072|"     Safety/Efficacy of 100-mg Viagra at 8 hours post dose in men with mild to moderate erectile     dysfunction   "
175912|NCT00137085|"     We, the investigators at Queen's University, propose to conduct a randomized, double-blind,     feasibility trial comparing low-dose ketamine versus fentanyl as adjuncts to Emergency     Department procedural sedation with propofol. The outcomes of interest will be safety, with     respect to hemodynamic and respiratory adverse effects, as well as efficacy, with respect to     adequacy of sedation and analgesia, recovery profiles and patient/physician satisfaction. Our     hypothesis, based on a review of existing anesthesia literature, is that low-dose ketamine     may be a safer and more efficacious alternative to fentanyl when used as an adjunct to     propofol-assisted procedural sedation.   "
175913|NCT00137098|"     Sudden cardiac death due to a heart rhythm disturbance after a heart attack (myocardial     infarction) is a common cause of death. It is well documented that sudden cardiac death after     a myocardial infarct (MI) is associated with low or poor heart rate variability (HRV). HRV is     a measure of beat-to-beat changes in heart rate, with a greater variation associated with a     healthier heart. The effect of caffeine on HRV in patients at high risk for sudden cardiac     death is unknown. We, the investigators at the Royal Bournemouth Hospital, aim to study the     effect of coffee or tea on HRV after MI.   "
175914|NCT00137111|"     The primary objective is to estimate the overall event-free survival of children at least one     year of age at diagnosis who are treated with risk-directed therapy and to monitor the     molecular remission induction rate.   "
175915|NCT00137124|"     Essential hypertension is characterized by impaired endothelial function. Data derived from     normotensive subjects with a genetic predisposition to arterial hypertension suggest that     endothelial dysfunction is a cause rather than a consequence of the condition. Given that, in     normotensive offspring of hypertensive parents, impaired endothelium dependent vasodilation     can be restored by supplementation of the nitric oxide (NO) precursor L-arginine, a defect in     the L-arginine/NO pathway can be postulated. The investigators at the University of     Erlangen-Nuremberg, hypothesize that impaired endothelial function in essential hypertension     is associated with alterations in L-arginine metabolism and transport. This study will     determine whether metabolism and transport of L-arginine are altered in patients with     essential hypertension and whether these potential alterations can be targeted     therapeutically.   "
175916|NCT00137137|"     This is a clinical trial to evaluate the mini-screw as orthodontic anchoring. This trial will     study implant survival, clinical efficiency and experience of the patient.   "
175917|NCT00137150|"     This study is a comparison of outcome and complications encountered in flapless surgery and     immediate loading versus the classical surgical approach and loading after 6-8 weeks in the     posterior maxilla.   "
175918|NCT00137163|"     The purpose of the study is to compare one type of dressing against the current standard     dressing that is used to cover the unburned area of the skin where a piece of skin is removed     to cover another part of the body that was burned.      Hypothesis: The mean healing time for wounds treated with the Dermafill dressing will be less     than the mean healing time for wounds treated with Xeroform dressing.   "
175920|NCT00137189|"     The aim of this study is to examine whether resource-oriented music therapy helps psychiatric     patients with low therapy motivation to improve negative symptoms and other health-related     outcomes.   "
175923|NCT00143052|"     The purpose of this study is to investigate how the bones of hirsute women are different from     bones of healthy women. The change in hormone content in the blood will also be investigated.     The study can be used to evaluate whether it will be relevant to bone scan all newly referred     hirsute women.      Hirsute women are often over-weight and often have an increased amount of the male sex     hormone in their blood. Their blood tests often show changes reminding of the ones seen in     diabetic patients.      All hirsute women referred to the department will undergo an investigation revealing the     reason for the increased hair growth. The investigation includes clinical investigation     (height, weight and degree of hair growth), blood tests (for hormone status and bone status     analysis) and bone scanning of the abdomen (body composition).      The trial includes a group of 50 strongly hairy women and a control group of 50 healthy women     with normal hair growth. They are matched by body weight, since weight has great importance     for the bone mineral content and thereby for osteoporosis in the long run.   "
175983|NCT00143884|"     This research project will focus on whether it is safe and effective to rely on donor cells     to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell     transplant.   "
175925|NCT00143078|"     The purpose of this study is to examine how obesity and weight loss following bariatric     surgery affect reproductive function. The study is particularly interested in how changes in     hormones (those produced in the stomach and fat tissue) following weight loss affect     reproductive function. Specifically, we, the researchers at Penn State University, propose to     characterize reproductive abnormalities in morbidly obese men and women. We hypothesize that     morbid obesity leads to reproductive abnormalities in men and women. We plan to examine the     short-term effects of alteration in GI hormones after bariatric surgery on reproductive     function. We hypothesize that bariatric surgery radically alters GI hormone expression,     resulting in immediate changes to the hypothalamic-pituitary-gonadal axis in men and women.     Lastly, we, the researchers, plan to examine the long-term effects of weight loss and changes     in adipokines on reproductive function. We hypothesize that the changes in adipokine levels     resulting from fat mass reduction lead to substantial long-term improvements in reproductive     function and fertility. We also hypothesize that there are sexual dimorphisms in adipokine     levels following weight loss, with women experiencing larger changes than men.   "
175926|NCT00143091|"     A six week, fixed dose, double-blind, double-dummy, placebo, and active controlled,     multicentre trial to evaluate the safety and efficacy of CP-316,311 in outpatients with major     depressive disorder.   "
175927|NCT00143104|"     To examine the lung when people with diabetes take an inhaled form of insulin, compared to     subcutaneous insulin.   "
175928|NCT00143117|"     To determine whether UK-390,957 is an effective and safe treatment for premature ejaculation.   "
175929|NCT00143130|"     To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive     treatment in patients with partial seizures.   "
175930|NCT00143143|"     The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in     patients with partial seizures.   "
175931|NCT00143156|"     To evaluate the efficacy and safety of pregabalin administered twice a day compared to     placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.   "
175932|NCT00143169|"     To validate the morphine-sparing effect and safety of parecoxib administered intravenously     for the treatment of Chinese subjects with postoperative pain following gynecological or     orthopedic surgery.   "
175933|NCT00143182|"     Bipolar disorder is characterized by mood swings that range from high (manic) to low     (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed     episodes). Asenapine is an investigational medication for the treatment of manic or mixed     episodes of bipolar disorder. Patients who completed the 3 week trial (A7601004 or A7501005)     continued on the same treatment that they received in the short term study: asenapine or     olanzapine (a medication already approved for the treatment of bipolar mania) for 9     additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the     9 week extension study was unblinded. Patients treated with placebo in the 3 week short term     study were crossed over and treated with Asenapine in the 9 week extension study. Patients     who complete the 9 week extension study were eligible to continue in another extension     (A7501007) study for an additional 40 weeks.   "
175934|NCT00143195|"     The objective of study is to compare the anti-ischemic efficacy and safety profiles of once     daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and     symptomatic myocardial ischemia   "
175935|NCT00143208|"     This study is designed as an open label evaluation of the efficacy of latanoprost and timolol     fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at     the baseline visit. All current ocular hypotensive therapy must be discontinued at this time.     On baseline day, patients eligible for the study will receive Xalacom which is to be     instilled in the morning.   "
175936|NCT00143221|"     The purpose of this study is to determine whether Viagra is effective in treating erectile     dysfunction and lower urinary tract symptoms in men affected by both conditions.   "
175937|NCT00143234|"     The purpose of the study is to measure the effect of the amlodipine/atorvastatin combination     pill in reducing both elevated blood pressure and cholesterol levels to levels suggested by     guidelines   "
175938|NCT00143247|"     This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera®     (inhaled insulin).   "
175939|NCT00143260|"     Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile     dysfunction   "
175940|NCT00143273|"     To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD     in postmenopausal Asian women.   "
175941|NCT00143286|"     The primary purpose of this study is a comparison of abstinence maintenance in subjects     randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded     to an intial 12-week open label course of varenicline, with post-treatment follow-up of     smoking status to Week 52.   "
175942|NCT00143299|"     The primary purpose of this study is to obtain safety information on cigarette smokers     treated with 52 weeks of varenicline regardless of smoking status.   "
175943|NCT00143312|"     To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell     transplants   "
175946|NCT00143351|"     To assess the long-term efficacy of oral Ziprasidone in the maintenance treatment of     resistant schizophrenic subjects who have benefited from participation in the phase III     ziprasidone study A1281039 (MOZART study), to assess the efficacy of ziprasidone in the     relapse prevention of schizophrenia, to collect long-term data on safety and tolerability of     oral Ziprasidone   "
175947|NCT00143364|"     The primary purpose of this study is to evaluate the safety and efficacy of varenicline given     for a twelve week treatment period in comparison with placebo and Zyban for smoking     cessation.   "
175948|NCT00143429|"     Compare the antihypertensive efficacy of three methods for installing Xalatan   "
175949|NCT00143442|"     The purpose of this study is to determine the effectiveness of [S,S]-Reboxetine in the     treatment of chronic pain following a shingles infection in patients who are Gabapentin     treatment failures.   "
175958|NCT00143559|"     Blood and marrow stem cell transplant has improved the outcome for patients with high-risk     hematologic malignancies. However, most patients do not have an appropriate HLA (immune type)     matched sibling donor available and/or are unable to identify an acceptable unrelated HLA     matched donor through the registries in a timely manner. Another option is haploidentical     transplant using a partially matched family member donor.      Although haploidentical transplant has proven curative in many patients, this procedure has     been hindered by significant complications, primarily regimen-related toxicity including GVHD     and infection due to delayed immune reconstitution. These can, in part, be due to certain     white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize     the body tissues of the patient (the host) are different and attack these cells. Although too     many T cells increase the possibility of GVHD, too few may cause the recipient's immune     system to reconstitute slowly or the graft to fail to grow, leaving the patient at high-risk     for significant infection.      For these reasons, a primary focus for researchers is to engineer the graft to provide a T     cell dose that will reduce the risk for GVHD, yet provide a sufficient number of cells to     facilitate immune reconstitution and graft integrity. Building on prior institutional trials,     this study will provide patients with a haploidentical graft engineered to specific T cell     target values using the CliniMACS system. A reduced intensity, preparative regimen will be     used in an effort to reduce regimen-related toxicity and mortality.      Two groups of patients were enrolled on this study. One group included those with high-risk     hematologic malignancies and the second group included participants with refractory     hematologic malignancies or undergoing a second transplant. The primary aim of the study was     to estimate the relapse rate in the one group of research participants with refractory     hematologic malignancies or those undergoing second allogeneic transplant. Both groups will     be followed and analyzed separately in regards to the secondary objectives.      This study was closed to accrual on April 2006 as it met the specific safety stopping rules     regarding occurrence of severe graft vs. host disease. Although this study is no longer open     to accrual, the treated participants continue to be followed as directed by the protocol.   "
175959|NCT00143572|"     The purpose of this study is to estimate the MTD of Mg pidolate in combination with HU in     patients with sickle cell disease who have been on a therapeutic dose (15-30 mg/kg/day) of HU     for at least 6 months.   "
175960|NCT00143585|"     To demonstrate the clinical efficacy and safety of vascular endothelial growth     factor(VEGF165)when delivered by direct myocardial injection through the NOGA navigational     catheter to improve myocardial perfusion in patients with severe angina pectoris for whom     conventional PCI or CABG are either not possible or not ideal.Secondary objective will be to     determine the effects of VEGF gene therapy on angina symptoms, patient perceived quality of     life and exercise capacity   "
175961|NCT00143598|"     The purpose of this study is to determine whether elastic compression stockings used for 2     years are effective in preventing the post-thrombotic syndrome in patients with symptomatic     proximal deep venous thrombosis.   "
175962|NCT00143611|"     The purpose of this study is to determine the optimal dose of Resatorvid for reducing 28-day     all-cause mortality in subjects with severe sepsis.   "
175963|NCT00143624|"     This trial will study the effect of rosiglitazone on the progression of atherosclerosis     (hardening of blood vessels) through improvements of the sugar and fat metabolism (body     buildup, breakdown and excretion of sugar and fat).      Participants will be randomly assigned to one of two groups: the first group will receive 8     mg of the study drug and the second group will be given a placebo, though neither group will     know which formulation they are receiving. The study will follow both groups for one year,     during which it will measure changes in blood vessel composition and activity, sugar     metabolism, concentration of blood fat, and body fat distribution. This single-site study     aims to enroll 50 participants.   "
175964|NCT00143637|"     The study is focused at the dose response relation for office dust and such office dust     spiked with components from fungi known from damp buildings.      The first aim of this study is to investigate if dust causes objective changes such as     changes of lung function, nasal geometry, inflammatory indicators in tears and nasal lavage,     tear film stability and cells at exposure levels relevant to indoor air. The controlled     exposure variable is air concentration of office dust spiked with Glucan to simulate a worse     case scenario.      Aim 1: Confirm or support the causality between objective effects and exposures to dust     spiked with Glucan with focus on inflammatory responses. This is done by negation of the     hypothesis that no significant effects are found for the variables in question.      Aim 2 is to estimate the thresholds and slopes of the DR relation for effect measures which     show effects of exposures. At best the study will supply for each variable a zero response to     clean air and three non-zero responses to dust. Thresholds and slopes are estimated     graphically by linear regression or by an accumulated response model.      Aim 3 is a confirmation that atopic persons and histamine sensitive persons in nasal     provocation tests have different responses in the effect measures showing significant effects     of exposures to dust spiked with Glucan. Risk group status is therefore included in the     analyses of the main variables as explaining variable.      Potential additional aim 4: Chemical and biological characterization of the office dust used     in the study.      Aim 4 is an investigation of dose response relations for explorative measures, which in     previous investigations have showed indications of a dose response relation. For these no a     priory hypotheses exists and the analyses must be arranged ad hoc. The explaining variables     are exposure and risk group status.      One challenge in investigations of unspecific effects caused by mixed exposures is that few     specific objective effects measures are available and subjective measures have to be     introduced. Therefore there is a need for developments of new objective measures of health     effects of air pollution. Some of these are related to new biomarkers of respiratory effects     in a bio-sample taken as condensed exhaled breath.      Aim 5: Developments of new objective measures of health effects of air pollution. After the     experiment it will be investigated by logistic regression if a sensitivity index can be     established.   "
175965|NCT00143650|"     The study is focussed on two main questions:        1. The importance of dampness of the building and home dust as a factor of the subjects=          responses.        2. Can measures used in KLINIR predict the subjects’ responses to the dust?      This study therefore was arranged to test the following hypotheses:        1. Does dust in general cause inflammatory/body perceptions through e.g. an irritation          symptoms index.        2. Does the dust include effective odorants which affects an IAQ index?        3. Does dampness increase the content of organic or inorganic compounds e.g. of microbial          origin that causes the dust to be more reactive? (Differences between the two types of          dust)        4. Is the sensitivity of the subjects explaining the responses to exposures in a, b, or c?          (Subject group and sensitivity index)      As explorative investigations biomarkers for exposures and sensitivity for practical usage     are tested.   "
175966|NCT00143663|"     The purpose of this study is to determine if patients with elevated cholesterol, but not     taking any other lipid medication, could lower their cholesterol with administration of     lapaquistat acetate, once daily (QD).   "
175967|NCT00143676|"     The purpose of this study is to determine the efficacy of lapaquistat acetate, once daily     (QD), on lowering cholesterol in subjects already taking atorvastatin.   "
175968|NCT00143689|"     This study will compare a nucleoside reverse transcriptase inhibitor-sparing (NRTI-sparing)     regimen (Kaletra + nevirapine) to two nucleoside reverse transcriptase inhibitor-based     regimens (Combivir + nevirapine and Combivir + Kaletra).      Participants will be randomly assigned to receive one of the following drug combinations:        -  lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;        -  Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day;        -  Combivir and lopinavir/ritonavir twice a day.   "
175984|NCT00143910|"     This study began in 1993 as a prospective, natural history study of renal transplant     patients' medication compliance measured by using an electronic monitor on the cap of     medication vials. Hypothesis: Poor medication compliance predicts adverse outcomes.     Enrollment is closed.   "
175969|NCT00143702|"     The purpose of this study is to determine the best way to treat people on d4T (stavudine)     with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding     riboflavin and thiamine will also be assessed.      Participants will be randomly assigned to one of four groups:        -  Group 1 participants will continue to take d4T as part of their antiretroviral (ARV)          regimen, and will be given the vitamin supplements        -  Group 2 will continue to take d4T without vitamin supplements        -  Group 3 will switch from d4T to abacavir and receive the vitamins        -  Group 4 will switch from d4T to abacavir without vitamin supplements.      The study plans to involve eighty participants from Canada and Argentina for a treatment     period of 16 weeks and a follow-up visit at week 24.   "
175970|NCT00143715|"     Excessive prolongation of the international normalized ratio (INR) occurs frequently in     patients taking warfarin; in fact, about one in six INR values is above the desired range.     Excessive prolongation of the INR is clinically important because the risk of bleeding     approximately doubles for each one point increase in the INR beyond the usual therapeutic     range. Thus, treatment strategies which rapidly and reliably lower an excessively prolonged     INR into the desired range have the potential to reduce bleeding. When taken by patients with     INR values between 4.5 and 10, a small dose of oral vitamin K (1 mg to 2.5mg) reduces the INR     into the desired INR range in about 75% of cases within 24 hours of its administration. If     warfarin is simply withheld, and no vitamin K is given, about 25% of patients will have an     INR in the desired range at 24 hours. However, vitamin K is rarely given to such patients. In     a recent survey carried out by our group, less than 20% of such patients would have been     given low dose oral vitamin K by a group of physicians who regularly supervise warfarin     therapy.      The most common treatment for excessive prolongation of the INR is to simply withhold     warfarin and allow the INR to fall into the therapeutic range. Although this strategy is     effective its safety has never been adequately examined. In fact, recent evidence suggests     that patients with INR values of more than 6.0 who are treated with simple warfarin     withdrawal have a risk of major bleeding of 4% in the two weeks after they develop their     prolonged INR.      When asked why they did not give oral vitamin K to a non-bleeding patient who has an     excessively prolonged INR, physicians generally give one of three reasons: (1)They are not     convinced that oral vitamin K reduces bleeding. (2) They are concerned that oral vitamin K     may cause thrombosis. (3) In contrast with simply withholding warfarin, giving oral vitamin K     requires a patient to visit the physician, and the physician must have a supply of vitamin K.      The investigators hypothesize that the routine practice of not administering oral vitamin K     to patients with excessively prolonged INR values is causing patients to have major,     life-threatening and fatal bleeds. To convince physicians that oral vitamin K should be     administered to all non-bleeding patients with INR values of more than 4.5, the investigators     propose a study which the investigators anticipate will demonstrate that oral vitamin K     reduces bleeding, does not cause thrombosis, and can be administered at home without direct     physician supervision.      To accomplish these goals, the investigators propose a multinational, double-blind,     placebo-controlled trial. The investigators will randomize patients with INR values between     4.5 and 10.0 to receive 1.25 mg of oral vitamin K or placebo and follow them for bleeding and     thrombosis. Patients with INR values of more than 10.0 will receive a single 1.25 mg dose of     oral vitamin K.      Successful completion of this study will establish a treatment standard supported by clinical     data which will, in turn, change the way that patients taking warfarin who present with an     excessively prolonged INR are treated.   "
175971|NCT00143728|"     The purpose of this study is to compare the effects of continuing or discontinuing 3TC     treatment in the presence of HIV virus with 3TC resistance for persons who are on a regimen     including least three other anti-HIV drugs. The overall aim is to determine whether     continuing 3TC is of benefit in HIV-positive persons who have already shown resistance to     this drug.   "
175972|NCT00143741|"     The purpose of this study is to identify subjects who are highly sensitized with antibodies.     It is difficult for these patients to find suitable kidneys. We propose to treat such     patients to decrease the antibodies in such a way, that it may become possible to safely     transplant kidneys into them.   "
175973|NCT00143754|"     Beneficial effect of chronic hydration with salt supplementation in patients with recurrent     unexplained syncope is not established. We sought to determine if chronic oral rehydration     with salt supplementation improved the tolerance and hemodynamic responses of patients with     unexplained recurrent syncope.   "
175974|NCT00143767|"     The primary purpose of this study is to investigate brain whether ADHD represents a     disruption or a delay of brain development. Children and adolescents both with and without     ADHD are asked to participate in several MRI sessions, two years apart. This will allow us to     chart brain development over time, both in typical development and ADHD, and therefore to     address whether ADHD represents a disruption or a delay of typical brain development.   "
175975|NCT00143780|"     Streptococcus pneumoniae, also known as Pneumococcus, is a common cause of pneumonia in     transplant patients. There has been a vaccine available for this infection called Pneumovax.     Recently, a new vaccine for this infection called Prevnar has been developed which may be     more effective. Vaccinating the bone marrow donor before transplant may boost the recipient's     immune response to the vaccine after transplant. This study is done to compare how     vaccinating the donor with one of the vaccines will affect the recipient's immune system     response to the vaccine.   "
175976|NCT00143793|"     The objectives of this study are to:        -  Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain          natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure          in patients with acute dyspnea and/or edema.        -  Determine the exact biomarker cut-off point(s) for the differentiation of healthy          persons, patients with heart failure and patients with dyspnea of other origin.        -  Evaluate treatment costs in patients with dyspnea under special consideration of          NT-proBNP measurement.   "
175977|NCT00143806|"     The purpose of this study is to devise a safe and effective method for transitioning patients     from cyclosporine to alefacept.   "
175978|NCT00143819|"     The purpose of this study is to assess the efficacy of Neuroskin Forte in relieving the     symptoms of dry skin in adults with psoriasis or eczema.   "
176014|NCT00144300|"     To determine if there is any difference in the presence of retinal deterioration in PD     patients treated with pramipexole IR versus ropinirole as monitored by comprehensive     ophthalmologic assessments from baseline to the end of study at two years.   "
176015|NCT00144313|"     The purpose of this study is to determine immune status of adolescents who responded to a     primary series of recombinant hepatitis B vaccine given at birth and to assess their response     to a booster dose of vaccine.   "
184549|NCT00258674|"     The purpose of this study is to test the effectiveness of physician profiling and care     coordination by a diabetes resource nurse in improving the quality of diabetes care.   "
175979|NCT00143832|"     Poor inhibitory control has been proposed to be central to the cognitive deficits and     symptomatology associated with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a     highly heritable disorder with an increased incidence among the siblings of affected     individuals. In the current proposal we investigate the expression of genetic susceptibility     for ADHD in brain functioning. We will study cognitive functioning in patients with ADHD,     their unaffected siblings and healthy matched controls. Our aims are 1) to determine whether     increased familial risk for ADHD is associated with differential patterns of brain activation     compared to normally developing children, during the performance of tasks designed to probe     cognitive functions that are compromised in ADHD and 2) to determine whether differential     patterns of activation are similar for boys with ADHD and their unaffected siblings.   "
175980|NCT00143845|"     The purpose of this study is to determine whether a reduced intensity conditioning regimen     for stem cell transplant with donor cells will allow the donor cells to be effective without     causing health problems.   "
175981|NCT00143858|"     The purpose of this study is to determine the clinical usefulness of measuring the heart's     pumping ability by measuring the Peripheral Pulse Volume (PPV).   "
175982|NCT00143871|"     This study is being conducted to determine the safety, side effects, and response to a     combination of an established high-dose chemotherapy regimen, plus the addition of Rituximab     (which is a form of immunotherapy).   "
175985|NCT00143923|"     This Western Pennsylvania-based study will (1) improve cardiovascular risk stratification to     identify high-risk populations, (2) identify disparities in cardiovascular risk based on     race, socioeconomic status, and geographic location, (3) evaluate mechanisms for population     differences in cardiovascular risk, and (4) implement a multidisciplinary community-based     intervention program to decrease cardiovascular risk in high-risk populations. These goals,     which are designed to eliminate ethnic and racial health disparities, are closely tied to the     National Initiative to Eliminate Racial and Ethnic Disparities in Health and the nation's     health promotion and disease prevention agenda established in Healthy People 2010.      This is a prospective cohort study of 2,000 residents of the state of Pennsylvania with     approximately equal representation of white and African American subjects. All participants     will undergo assessments of traditional and nontraditional risk factors to identify and     determine the mechanisms of population disparities in cardiovascular risk. 800 participants     who are at intermediate or high risk of cardiovascular disease will be randomly assigned to     either (1) usual care/advice only; or (2) a multidisciplinary behavioral modification     program to determine the most effective approach to reduce or eliminate racial, socioeconomic     and geographic disparities in cardiovascular risk. All participants will undergo long-term     follow-up for cardiovascular events.   "
175986|NCT00143936|"     This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet)     with a high carbohydrate diet (conventional USDA diet).   "
175987|NCT00143949|"     To determine if renin angiotensin medications can prevent or delay the onset of diabetic     kidney disease.   "
175988|NCT00143962|"     This is a follow-up research study to determine if there are any differences in the long-term     maintenance of two diet groups, the Atkins' diet (low-carbohydrate) or the LEARN program     (low-fat). The Atkins' diet continues to get a significant amount of popular attention and     very little scientific evaluation. Due to the small amount of scientific data to support a     low-carbohydrate diet and given the wide spread use of this type of diet, it is important to     evaluate the long-term safety and effectiveness of the Atkins' diet.      We will evaluate whether there are any differences between these two groups 3-years after     participation in the initial 1-year study period. We will specifically assess weight,     cholesterol levels, glucose and insulin levels, and eating habits and mood as we did     originally.   "
175989|NCT00143975|"     GO-A-HAM:      Gemtuzumab Ozogamicin 3g/m² day 1 Cytarabine 3g/m² bid days 1-3 Mitoxantrone 12mg/m² days 2,3     All-trans Retinoic acid 45mg/m² days 4-6 and 15 mg/m² days 7-28   "
175990|NCT00143988|"     The purpose of this study is to determine the amount of cardiac work as measured by heart     rate and blood pressure during physical exertion compared to sexual activity.   "
175991|NCT00144001|"     Nearly 2% of veterans >65 are actively treated for epilepsy, and the incidence is projected     to increase with the aging of our society. Since commonly used antiepileptic drugs are     considered suboptimal for older patients, it is important to understand existing patterns of     treatment for older veterans with epilepsy.   "
175992|NCT00144014|"     A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in     acute ischaemic stroke   "
175993|NCT00144027|"     Efficacious antipsychotic medication treatments for schizophrenia are available; however ,     antipsychotic regimens frequently do not achieve their potential because of poor medication     adherence. To date, medication adherence interventions have not been widely adopted or     sustained in real-world practice settings. One reason for this is the substantial resource     investment necessary to implement and sustain available interventions. In response to these     problems, we developed a patient-centered adherence intervention based on patient-identified     barriers, facilitators, and motivators (BFMs) for medication adherence. The intervention     includes a BFM survey (checklist and preference weighting exercise to determine the patient's     most important BFM) and a brief list of adherence enhancing suggestions (Options List)     tailored to the patient-identified BFMs and compatible with CPRS. The long-term objective of     this proposed research is to improve antipsychotic medication adherence and clinical outcomes     for patients with schizophrenia using a cost-effective medication adherence intervention. The     short-term objectives are to refine and test a patient-centered medication adherence     intervention for VA patients with schizophrenia and specifically to: 1. Enhance the     feasibility and acceptability of the BFM intervention by reducing the burden on patients and     mental health providers through BFM checklist item reduction, provider intervention input,     and patient intervention input. We hypothesize that our use of end-user input will result in     at least 80% of intervention patients having documentation of a BFM intervention in CPRS. 2.     Compare the effects of the BFM intervention versus usual care on changes in medication     adherence and schizophrenia symptom severity. We hypothesize that the intervention will     result in a) greater medication adherence and b) lower schizophrenia symptom severity than     usual care. 3. Exploratory objective: compare the effects of the BFM intervention versus     usual care on changes in patient health-related quality of life. We hypothesize that the     intervention will result in greater health-related quality of life than usual care.   "
176016|NCT00144326|"     The objective of this study is to determine if tiotropium (Spiriva, Bromuro de Tiotropio) 18     mcg once daily by oral inhalation compared to placebo increases the magnitude of daily     physical activity observed in COPD patients, measured using an accelerometer.   "
176017|NCT00144339|"     The primary objective of this trial is to determine whether daily treatment with tiotropium     (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of     decline in lung function over time in patients with COPD.   "
176031|NCT00144521|"     The purpose of this study is to investigate the clinical efficacy and safety of MRA in a     double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid     arthritis (RA) patients with MTX administered.   "
175994|NCT00144040|"     Purpose The emergence and rapid rise in antibiotic resistance among common bacteria are     adversely affecting the clinical course and health care costs of community-acquired     infections. Because antibiotic resistance rates are strongly correlated with antibiotic use     patterns, multiple organizations have declared reductions in unnecessary antibiotic use to be     critical components of efforts to combat antibiotic resistance. Among humans, the vast     majority of unnecessary antibiotic prescriptions are used to treat acute respiratory tract     infections (ARIs) that have a viral etiology. Although the rate of antibiotic prescribing for     ARIs by office-based physicians in the US has decreased about 16% from its peak in 1997, the     rate of antibiotic prescribing in acute care settings (eg, emergency departments and urgent     care centers), which account for 1 in 5 ambulatory antibiotic prescriptions in the US, has     shown only a modest decline (6%) during this period. Translation of lessons from intervention     studies in office-based practices is needed to improve antibiotic use in acute care settings.   "
175995|NCT00144053|"     To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over     concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable     stage III NSCLC.   "
175996|NCT00144066|"     A randomized phase III trial of platinum-based chemotherapy alone versus platinum-based     chemotherapy followed by maintenance therapy with gefitinib in patients with stage IIIB/IV     NSCLC.   "
175997|NCT00144079|"     The trial examines the clinical benefit of adjuvant external beam radiotherapy (RTx) for     locally invasive differentiated carcinoma (TNM stages pT4 pN0/1/x M0/x; 5th ed. 1997) of the     thyroid gland (DTC). Patients are treated with surgery (thyroidectomy and lymphadenectomy),     radioiodine therapy (RIT) to ablate the thyroid remnant tissue, and TSH-suppressive     L-thyroxine therapy with or without RTx after documented elimination of cervical I-131     uptake.   "
175998|NCT00144092|"     Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem     cell transplanation.   "
175999|NCT00144105|"     Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an     active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected     patients   "
176001|NCT00144131|"     This study will compare the efficacy (non-inferiority) of darbepoetin alfa (Aranesp®)     extended dose schedule administration (EDS) versus darbepoetin alfa administered once per     week (QW) in the treatment of anemia in subjects with non-myeloid malignancies receiving     multi-cycle chemotherapy.   "
176002|NCT00144144|"     The antihypertensive effect of the increased dose of angiotensin II receptor blocker (AII     antagonist) is compared with that of the additional combined use of amlodipine in     hypertensive patients with Type 2 diabetes mellitus, who have been treated with AII     antagonist, the antihypertensive effect of which has been inadequate.   "
176003|NCT00144157|"     To determine the response to treatment with NVP, ZDV and 3TC in HIV positive women, who     previously received NVP for the prevention of mother to child transmission.   "
176004|NCT00144170|"     The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir     versus an active control arm in highly treatment experienced Human immunodeficiency virus-1     infected patients. Patients must have a viral load > =1000 cells/mL, and genotype indicating     at least one resistance conferring protease inhibitor-mutation as determined from a     predefined panel of mutations. Any CD4+ count is acceptable.   "
176005|NCT00144183|"     To determine whether a regimen of single dose nevirapine combined with either 4 or 7 days of     Combivir®, compared to a regimen of single dose nevirapine, for the prevention of mother to     child transmission can reduce the rate of development of drug resistant mutations of HIV-1,     in HIV-1 infected pregnant women, who have not received antiretroviral therapy previously.   "
176006|NCT00144196|"     To show that treatment with tiotropium inhalation capsules (18 μg q.d.) via HandiHaler®     improves lung function in patients with mild COPD according to Swedish guidelines.   "
176007|NCT00144209|"     The primary objective of this study is to determine that pramipexole (Sifrol) 0.25 mg to 0.75     mg daily is not inferior to levodopa 100 mg to 300 mg (in combination with benserazide 25mg     to 75mg = Madopar DR) daily in the treatment of patients with idiopathic restless legs     syndrome fulfilling the International Diagnostic Criteria. The efficacy parameters include an     objective measure of the leg movements during the time spent in bed, and a quantitative     clinical assessment of the severity of RLS, in the form of the RLS-score. In addition, the     efficacy evaluations aim at comparing the impact of pramipexole and levodopa on outcome     measures such as quality of life and sleep.   "
176008|NCT00144222|"     The objective of this trial is to demonstrate that the fixed dose combination of telmisartan     40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis, Gliosartan,     Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) 40 mg in patients with essential     hypertension who fail to respond adequately to telmisartan monotherapy.   "
176009|NCT00144235|"     To assess the efficacy and safety of Pharmaton? PHL 00749 in improving cognitive function and     allevi ating mental and physical stress in healthy male and female subjects leading demanding     lifestyles.   "
176010|NCT00144248|"     The objective of this study was to evaluate the steady-state clearance of nevirapine among     HIV-1 positive patients with hepatic fibrosis, and to examine whether the degree of hepatic     impairment influences clearance.   "
176011|NCT00144261|"     1. In order to obtain further insight as to how NVP affects HDL metabolism, the in vivo          kinetics of the HDL apolipoprotein, Apo A-1, before and 6 weeks after initiation of NVP          containing treatment were evaluated. In addition, the activity of the key enzymes          related to HDL metabolism were assessed.           [ Designated as safety issue: No ]        2. In order to determine the relevance of the HDL increase in decreasing cardiovascular          risk in HIV-positive subjects we evaluated endothelial function (FMD) as a surrogate          marker for cardiovascular disease in patients.      [ Designated as safety issue: No ]   "
176012|NCT00144274|"     The purpose of this trial is to investigate efficacy and tolerability of lozenges containing     20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in     adolescent patients suf fering from acute viral pharyngitis. The primary endpoint is the     time-weighted average of the pain intensity difference from pre-dose bas eline over the first     3 hours after the first lozenge expressed as a ratio of the pre-dose baseline ( SPIDnorm).   "
176018|NCT00144352|"     Plasmodium falciparum malaria and HIV are among the most important infectious diseases in     sub-Saharan Africa. Approximately two-thirds of the estimated 35 million HIV infected persons     live in sub-Saharan Africa. Of the 300-500 million annual cases of malaria infection     occurring worldwide, about 90% of P. falciparum infections occur in sub-Saharan Africa,     resulting in approximately 1 million deaths, mostly in children under five years of age. It     is clear that HIV and malaria are responsible for substantial disease, suffering, and an     enormous economic burden on the people who can least afford it. Although a study in 1993 in     Tanzania showed significantly higher prevalence of malaria infections in HIV-positive     compared to HIV negative adults, until recently there have been few studies showing any     association between the two infections.      We conducted a study to measure the efficacy of the then-first line antimalarial drug     (sulfadoxine-pyrimethamine) among patients in three study arms: those who were HIV negative,     those who were HIV infected with CD4 cell counts < 200, and among HIV infected patients with     CD4 cell counts >= 200. Our hypothesis is that patients with HIV infection and low CD4 cell     count will not respond to antimalarial therapy as well as patients who are HIV infected with     higher CD4 cell counts or who are HIV negative.   "
176019|NCT00144365|"     The study is a 3-year, randomized trial to compare ART delivery through two different models:     a) ART delivered through health facilities by clinically qualified staff and b) home-based     care in which lay workers, i.e. non-medically qualified people, play a major role in the ART     delivery and clients are followed up at health facilities less frequently. The primary     objective is to measure the effects of these strategies on HIV viral load. We will also     examine the effects on treatment failure, disease progression, survival, adherence, family     member HIV testing, sexual behavior, and cost-effectiveness.   "
176020|NCT00144378|"     The median survival at progression after first-line chemotherapy for metastatic gastric     cancer is about 2.5 months. There are no data which a possible benefit of second line     therapy. for this reason a trial which investigates a possible benefit or chemotherapy     compared to best supportive care as second line treatment is urgently necessary.      Irinotecan shows response rates of 20% in the first line therapy with high rates od disease     stabilization. There are few trials investigating irinotecan in the second line setting.     Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from     the company Pfizer.   "
176021|NCT00144391|"     The principal aim of this study is to evaluate if application of testosterone gel leads to     improvement in measures of sexual function, thinking ability and quality of life in women     with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of     testosterone replacement on body composition and muscle function and strength.   "
176022|NCT00144404|"     The purpose of this study is to determine the blood levels of testosterone gel administered     for a week to women with hypopituitarism and determine if this leads to testosterone     replacement in a normal range for women. An additional objective is to determine the baseline     laboratory abnormalities and physical, brain function, emotional and sexual symptomatology of     these women with hypopituitarism.   "
176023|NCT00144417|"     This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in     daily treatment during the first two months of treatment with rifampin, pyrazinamide and     ethambutol for sputum smear-positive pulmonary tuberculosis.   "
176024|NCT00144430|"     This is a multicenter trial through the Pediatric Blood and Marrow Transplant Consortium.      The Primary hypothesis of this study is that because of its effect as a potent     immunosuppressive agent targeting lymphocytes, pentostatin will show a sustained response in     pediatric subjects with severe chronic GVHD. Secondary hypotheses include that the infection     and toxicity rate of pentostatin in this setting will be acceptable given its lack of severe     myelosuppression, and subjects with refractory chronic GVHD will have significant QOL     impairment and symptomatology. These may change as subjects are being treated for their     chronic GVHD with pentostatin.   "
176025|NCT00144443|"     Objective: Our overall objective is to test the hypothesis that the health of children with     chronic respiratory symptoms or chronic exposures to environmental hazards can be improved     through a combination of standard home maintenance interventions and a set of interim     controls and targeted repair interventions.      I. Background:      The Bi-State Kansas City Enhanced Enterprise Community (KCEEC) is one of pervasive poverty,     unemployment and general distress. This same area is also an area of poor environmental     health with a disproportionate number of children with lead poisoning, asthma, and home     injuries.      In May 2001, the Metropolitan (Kansas City) Health Council released a report urging the     implementation of strategies to address this growing concern. They stated, “Environmental     assessments and interventions in homes, schools, and workplaces are needed to promote indoor     air quality and thereby help prevent asthma and asthma flare-ups,” in combination with the     need for, “trained community-based peer educators needed to work with families/communities in     areas of high asthma incidence,”. The need for major rehabilitation is echoed in the 1999     Consolidated Plan, as well as by most community development and housing officials.      The KC CERT project responds to these concerns by demonstrating low-cost, replicable     intervention strategies that can have an impact on the health and safety of children and     their families. By providing training and employment opportunities to residents in high-risk     areas to assess, prevent and remediate environmental hazards, this project promotes sustained     systematic change within the KCEEC.   "
176026|NCT00144456|"     A prospective, randomized, double-blind study to compare the effect of ED-71 with that of     alfacalcidol on fracture incidence   "
176027|NCT00144469|"     This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus     ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with     peginterferon alfa-2a monotherapy.      Additionally, the study evaluated the efficacy and safety of the combination of peginterferon     alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous     conventional-interferon based therapy.   "
176028|NCT00144482|"     To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in     anemic cancer patients undergoing chemotherapy   "
176029|NCT00144495|"     The purpose of this study is to evaluate the effectiveness and safety of recombinant human     erythropoietin in anemic cancer patients undergoing chemotherapy.   "
176030|NCT00144508|"     To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to     receive either MRA or conventional DMARDs.   "
176040|NCT00144638|"     Procalcitonin, a marker of infection has often been compared to clinical pictures as for     instance clinical sepsis. This has given som problems in the interpretation of these     studies, because of the lack of good Gold Standards for clinical sepsis. We have decided to     investigate the development from day to day of Procalcitonin in the blood of intensive care     patients, compared to the mortality.      Hypothesis: Procalcitonin increase after reaching a certain level predicts mortality in the     Intensive Care Unit.   "
176041|NCT00144651|"     This is an open-label, extension, Phase II study to evaluate the long-term safety and     efficacy of MRA in Patients with RA who were participated in Study MRA009JP.   "
176042|NCT00144664|"     This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in     patients with pJIA.   "
176043|NCT00144677|"     The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus     host disease (GVHD) in patients following stem cell transplant from an unrelated donor. This     trial is designed to test the hypothesis that elimination of methotrexate in the unrelated     donor group would lead to less transplant-related toxicity while still preserving the     effective control of GVHD.   "
176044|NCT00144690|"     The primary objective of this study is to determine the maximal tolerated dose (MTD) of E2007     given twice daily (bid) or once a day (qd) in patients with refractory partial-onset seizures     (including secondarily generalized seizures). The secondary objectives are to evaluate the     safety, efficacy, concentration-efficacy relationship, and pharmacokinetics of E2007 and the     effects of E2007 on the Profile of Mood States (POMS) test.   "
176045|NCT00144703|"     The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus     host disease (GVHD) in patients following stem cell transplant from a related donor.   "
176046|NCT00144716|"     Insecticide Treated Nets (ITN's) offer good protection against malaria in Africa where the     vector mosquitoes feed indoors late at night. However, in other parts of the world like South     America, vectors feed earlier in the evening before people go to bed. In such cases it may be     necessary to use alternative treatments in the evening to supplement the efficacy of ITN's.     This study compares 2 matched groups of households in the Bolivian Amazon. One group will be     given ITN's plus a plant-based insect repellent in the evening, the other has ITN's plus a     placebo lotion. Households are monitored over a full malaria season to record numbers of     malaria cases.   "
176047|NCT00144729|"     A single arm dose optimization study in which all patients are given a fixed dose of Cytoxan     (4 x 50 mg/kg) plus ATG (3 x 30 mg/kg) and the TBI dose starting at 3 x 200 cGy is escalated     or de-escalated dependent upon engraftment and toxicity.   "
176048|NCT00144755|"     This study is a multicentric randomized trial evaluating the efficacy and safety of R-CHOP     given every 14 days compared to R-CHOP given every 21 days in association or not with     darbepoetin alfa in order to maintain hemoglobin above 13 g/dl, compared to classical     symptomatic treatment of anemia in patients aged from 60 to 80 years with diffuse large     B-cell lymphoma.   "
176049|NCT00144768|"     The purpose of this study is to determine whether the development of antibodies to laronidase     in patients with MPS I receiving Aldurazyme® impairs the clearance of GAG substrate.   "
176050|NCT00144781|"     The main purpose of this study is to evaluate differences in the pharmacodynamic response of     4 Aldurazyme® (laronidase) dose regimens in patients with Mucopolysaccharidosis I (MPS I).   "
176051|NCT00144794|"     The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that     tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will     provide information to better characterize the natural history and progression of MPS I as     well as the clinical responses of patients receiving enzyme replacement therapy, such as     Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities.      The objectives of the Registry are:        -  To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase)        -  To characterize and describe the MPS I population as a whole, including the variability,          progression, and natural history of MPS I        -  To help the MPS I medical community with the development of recommendations for          monitoring patients and reports on patient outcomes to optimize patient care   "
176052|NCT00144807|"     This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to     59 years with high risk diffuse large B-cell lymphoma   "
176053|NCT00144820|"     251 consecutive patients with knee arthrosis were randomized to one of three interventions:     Four weekly injections of 2 ml isotonic saline (placebo), 2 ml sodium hyaluronate     (hyaluronan) or 20 ml isotonic saline (excessive saline).      They all suffered from clinically and radiologically verified arthrosis of the knee with     daily pain that did not respond to treatment with analgetics.      Results were evaluated at weeks 1,2,3,4,8,12,16 and 26. Biochemical markers for bone and     cartilage degradation were measured in urine/blood.   "
176054|NCT00144833|"     For HIV-infected individuals with highly resistant viruses, higher drug levels may be     required to block the virus. This study investigates that concept by comparing the efficacy     of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a     combination of fosamprenavir (increased dose)/lopinavir/ritonavir.   "
176055|NCT00144846|"     This study evaluates the effect of cumulative dose administration of albuterol sulfate     inhalation aerosol delivered with valved holding chamber and facemask. This is a four week     study in birth to 23 month old subjects who are experiencing acute wheezing due to     obstructive airways disease.   "
176056|NCT00144859|"     This is a 28-day, placebo controlled clinical study assessing the safety, tolerability     anti-inflammatory effect and pharmacokinetics of SB681323 in patients with COPD (Chronic     Obstructive Pulmonary Disease).   "
176077|NCT00145132|"     Aim of this project is to investigate the effects of escitalopram on monoamine transporter     (SERT, DAT) availabilities as assessed by b-CIT and SPECT, and on neurophysiological     parameters such as the loudness dependence of auditory evoked potentials (LDAEP) in patients     with depression.   "
176078|NCT00145145|"     The purposes of this study are to determine whether immunization with the MAGE-3.A1 peptide     mixed with CpG 7909 results in a detectable immune response; to determine the safety of this     vaccine and; to document the tumor response to the vaccine.   "
176103|NCT00145470|"     This is a 12-week study that will test the safety and efficacy of asenapine when used in     addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I     Disorder.   "
176057|NCT00144872|"     This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the     treatment of newly-diagnosed typical absence seizures. Subjects will be children and     adolescents < 13 years of age. It will be conducted at multiple sites in the US. The study     will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation     Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing     doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by     hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At     that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not     achieve seizure freedom upon reaching the maximum dose (10.2mg/kg/day) with the specified     dose escalation will be discontinued from the study. During the Maintenance Phase, the     investigators will use their best effort to maintain the subjects at the efficacious dose     reached. If the subjects have unacceptable side effects or inadequate seizure control, the     doses of study drug can be increased or decreased as specified in the dosing schedule. Safety     will be assessed by monitoring adverse events, laboratory assessments, and serum lamotrigine     levels. Health outcomes assessments will also be conducted.   "
176058|NCT00144885|"     Patients with definite or possible infective endocarditis are included in this protocol, at     the acute phase of the disease.   "
176059|NCT00144898|"     Sentinel node resection appears as a promising advancement in the surgical treatment of     breast cancer.      The GF-GS 01 study, sponsored by a National Hospital Research Program, compares this new     surgical method with a classical method in patients having a negative sentinel node.      The duration of the follow-up is 5 years.   "
176060|NCT00144911|"     This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary     Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the     clinic 10 times. Subjects will be given breathing tests and will record their breathing     symptoms daily on diary cards. All study related medicines and medical examinations will be     provided at no cost. The two drugs used in this study have been approved by the FDA for use     in patients with COPD.   "
176061|NCT00144924|"     Comparison of open and laparoscopic pyloromyotomy   "
176062|NCT00144937|"     The purpose of this study was to evaluate whether an intensified multifactorial intervention     program about cardiovascular risk factors in subjects with peripheral arterial disease (with     and without diabetes mellitus), can improve the control of these factors (mainly     hypercholesterolemia and hypertension) in relation to the habitual care   "
176063|NCT00144950|"     This study will compare VATS versus chest drain insertion and urokinase in the treatment of     childhood empema by a randomised prospective study.   "
176064|NCT00144963|"     The purpose of this study is to find the highest safe dose and to assess the anti-tumor     effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory     acute lymphoblastic leukemia (ALL).   "
176065|NCT00144976|"     The purpose of this study is to evaluate the biological effect of Tarceva (OSI-774) from an     inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who     are carriers of head and neck epidermoid carcinoma.   "
176066|NCT00144989|"     To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage     small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent     accelerated hyperfractionated thoracic irradiation.   "
176067|NCT00145002|"     To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in     terms of survival benefit.   "
176068|NCT00145015|"     The purpose of the study is to determine whether increasing the dietary intake of n-3 fatty     acids by the consumption of oil-rich fish reduces the risk of developing colorectal cancer.   "
176069|NCT00145028|"     To determine Carboplatin's optimal exposures(optimal AUCs)and parameters they depend on.   "
176070|NCT00145041|"     The purpose of this study is to see how vincristine, when placed in an oil droplet called a     liposome (VSLI), is absorbed, distributed (moved around) and excreted from the the body     (pharmacokinetics). This study will also assess the safety of VSLI and to see if VSLI will     slow the growth or shrink tumors in patients with metastatic melanoma that has resulted in     liver impairment, and who have relapsed after previous therapies.   "
176071|NCT00145054|"     We propose to conduct a pilot trial of an Internet-only depression skills training program     for adolescents and young adults. The intervention, MoodHelper.org already exists and has     been tested in two pilots. In this third pilot, we plan to use an enriched minority sampling     frame to mail 3,000 to 6,000 invitational brochures to KPNW members aged 14 to 24, with a     enrollment target of 150. Interested members will go to the study Internet site, and if they     choose to participate, complete the online consent and assessment battery (used in the     previous pilots). Participants will be randomly assigned by the site’s software to one of two     conditions: (1) the “Intervention” condition, with complete access to the SADhelper.org web     site or (2) the Usual Care” condition, with access to all Internet sites and KPNW health     care, but with no access to the therapeutic portion of the SADhelper site. All participants     (those with and without access to the research intervention) will be reminded by e-mail and,     if necessary, by telephone to return to the web site and complete follow-up questionnaires     four, eight, sixteen, and thirty-two weeks after enrolling in the study.   "
176072|NCT00145067|"     The purpose of the study is to evaluate the impact disease management interventions in     treatment compliance among post-fracture and osteoporosis patients.   "
176073|NCT00145080|"     The purpose of this study is to assess the impact of disease management interventions on bone     mineral density screening rates and osteoporosis treatment rates in women age 50-64 years at     high risk for osteoporosis.   "
176074|NCT00145093|"     The purpose of this study is to determine whether chromium (yeast), is effective in improving     glycaemic control and insulin resistance.   "
176075|NCT00145106|"     The purpose of the study is to compare the efficacy of three maintenance regimens (topical     tazarotene, oral minocycline, or both) in sustaining improvement in acne.   "
176076|NCT00145119|"     The purpose of this study is to assess the incidence of tachy- and bradyarrhythmic episodes     in patients with acute myocardial infarction with depressed ventricular function and to     determine the predictive value of several invasive and non-invasive risk markers for     life-threatening arrhythmia   "
176079|NCT00145158|"     The purposes of this study are to describe the immune response to individual peptides after     immunization with a combination of 8 peptides and Montanide ISA-51; to determine the safety     of this vaccine and; to document the tumor response to the vaccine.   "
176080|NCT00145171|"     APO303 is a sub-study of patients enrolled in APO401 (the long-term open label safety     protocol) and was designed to evaluate adverse events, particularly blood pressure drops when     standing up during first dose in patients who have not been exposed to apomorphine before.   "
176081|NCT00145184|"     The purpose of this study is to see whether children who take vitamins along with the     standard medicine for tuberculosis (TB) recover better and quicker than children who take     only the standard medicine for TB. Four hundred children ages 6 weeks-5 years, who have been     diagnosed with tuberculosis, will be enrolled. They will be followed for 2 months after     treatment for TB. Study procedures may include blood draws, Tuberculin Skin Tests, body     measurements, gastric aspirates (removal of stomach fluid), physical exams, and     questionnaires. This study will occur in Tanzania.   "
176082|NCT00145197|"     The purpose of this study is to determine if a physician-centered intervention will help     women with early stage breast cancer receive appropriate treatment.   "
176083|NCT00145210|"     The purpose of this study is to evaluate the effects of nebivolol on blood pressure and heart     rate in African American patients with hypertension.   "
176084|NCT00145223|"     Wuchereria bancrofti, is a mosquito-transmitted parasite that causes deforming lymphatic     filariasis in the tropics. Improved treatment methods have led to new thinking that it should     be possible to interrupt transmission and eliminate this major public health problem by     repeated, annual cycles of mass treatment with new single dose combination drug regimens.     Egyptian villages involved in the study will be surveyed. Household members above 4 years of     age will be tested for filariasis. Also, children in the first year classes of primary     schools (5 to 6 years of age) will be tested for parasite infection. Village populations will     be treated for filariasis as part of the MOH national filariasis elimination program.     Children under age 5, pregnant women, and people with severe underlying illness are excluded     from the program.   "
176085|NCT00145236|"     The purpose of this study was to determine if nebivolol is superior to placebo for the     treatment of elevated blood pressure in Black patients with mild to moderate hypertension.   "
176086|NCT00145249|"     This study will examine the effectiveness and safety of a combination treatment for     cryptococcal meningitis, a fungal infection common in persons with acquired immune deficiency     syndrome (AIDS) in the developing world. The standard initial treatment includes two     medications: amphotericin B for 2 weeks followed by 8 weeks of fluconazole. This study will     look at whether study participants recover more quickly and have fewer side effects if they     are given both drugs at the same time for 2 weeks followed by 8 weeks of fluconazole as     compared to the standard treatment. Participants will be followed for approximately 6 months     from the time they are enrolled into the study.   "
176087|NCT00145262|"     Clinical studies have established that implantation of bone marrow mononuclear cells     (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases     collateral vessel formation. We, the investigators at Nagoya University, further investigated     the efficacy and safety of autologous implantation of BM-MNCs or PB-MNCs in patients with     severe ischaemic limbs who have no other alternative therapeutic options. We also examined a     potential limiting factor which reduced the efficacy of therapeutic angiogenesis using cell     transplantation (TACT).   "
176088|NCT00145275|"     Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such     as headache, fever, muscle aches, and pains, may occur following the infusion. This study     will investigate the use of over-the-counter medicines to improve these symptoms.   "
176089|NCT00145288|"     Hirsutism is the presence of terminal hairs in a male-like pattern in females, due to     elevated male hormone levels. Females with hirsutism are often overweight and have metabolism     disturbances as insulin resistance and impaired glucose tolerance.      The previous studies showed that patients with hirsutism (especially them with polycystic     ovarian syndrome (PCOS)) have an increased risk to develop type 2 diabetes mellitus on the     background of insulin resistance / hyperinsulinemia: 30-35 % of females with PCOS had     impaired glucose tolerance and 5-10 % of them diabetes. Hyperinsulinemia increases the risk     to develop dyslipidemia and cardiovascular diseases.      A previous study in our department who included 340 females with hirsutism (210 with     idiopathic hirsutism and 134 with PCOS) showed that 6.6% of them had diabetes and 55% insulin     resistance.      There were only few long-term follow up studies of patients with hirsutism concerning their     risk to develop diabetes. As far as we now, such studies on patients with idiopathic     hirsutism are not available until now.      Hirsutism is been treated with low dose oral contraceptives, which are suppressing androgen     production. This treatment can also influence the risk to develop diabetes and atheromatosis.     The previous studies showed that the low dose oral contraceptives had modest influence on the     lipid profiles and carbohydrate metabolism in patients with hirsutism, but increased the risk     to develop coronary disease.      Aim        -  To study and quantify, in patients with hirsutime, the risk to develop type 2 diabetes          on the background of insulin resistance / decreased glucose tolerance and atheromatosis          on the background of insulin resistance / hypercholesterolemia.        -  To clarify the effect of P-pills on patients hair growth and metabolism.   "
176090|NCT00145301|"     This trial will compare the retention on treatment (based on the rate of patients staying on     treatment for 1 year) of patients suffering from primary osteoarthritis using two different     doses of lumiracoxib (100 mg od or 100 mg bid) or using celecoxib (200 mg od)   "
176091|NCT00145314|"     The main objective of this trial is to explore the effect of combining an established     chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin     (Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of     metastatic colorectal cancer. The trial will investigate two regimens of FLOX plus cetuximab,     in which FLOX is given continuously or intermittently, compared to standard FLOX without     cetuximab.   "
176092|NCT00145327|"     This extension study is designed to assess the long term safety and efficacy of zoledronic     acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301     (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year     core study ended. Baseline is the same as Year 3.   "
176093|NCT00145340|"     In this study, the investigators wish to investigate how pioglitazone treatment effects     hirsute women. Hirsute women are often overweight and have an increased amount of male sex     hormone in their blood. Their blood tests show frequent changes corresponding to the changes     seen in diabetic patients.      Pioglitazone is a drug used for increasing the insulin sensitivity in diabetic patients.     Previous studies showed that this drug is able to decrease the level of insulin in blood in     hirsute women. Moreover, the level of male sex hormones is reduced during this treatment. The     drug has only been marketed for few years, and no investigations have been carried out as to     the reaction of other hormones, e.g. growth hormone and stress hormone, using this treatment.      This clinical trial includes 30 strongly hirsute women. The patients are randomized to either     placebo or an active drug. The treatment period is 16 weeks. The patients included must be     healthy and take no medicine possibly changing the results of the study. The patients must     take no contraceptive pills or receive any other hormone treatment.      In connection with the investigation, the following will be carried out on all patients:     glucose tolerance test, clinical examination, blood tests, measurement of stress hormones and     sex hormones, hyperinsulinaemic euglycaemic clamp test, muscle biopsies and bone scan.      This examination programme will be carried out before start of pioglitazone or placebo     treatment and again after 16 weeks of treatment. The examinations require 2½ days of     hospitalization.      The purpose of the study is to gain more knowledge of the reasons for hirsute women to grow     more hair than normal women. The study will show whether pioglitazone treatment can reduce     the amount of male sex hormone in blood and how the level of stress hormone and growth     hormone is changed when reducing the amount of insulin in blood.   "
176094|NCT00145353|"     The main purpose of the study is to investigate the reason for the reduced number of     hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin     Aspart at meals together with NPH insulin mornings and evenings, and when, in another period     of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and     when the patients in both periods simultaneously take extra insulin at meals if high blood     glucose values are found before meals.   "
176095|NCT00145366|"     The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine     treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter.     It is an introduction of a novel principle, based on prospective, randomized double blind     investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size     (measured by ultrasonography), both in healthy individuals and in patients with nontoxic     nodular goiter. Thus, the investigations are divided into 4 categories listed below:        1. Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human          TSH for the effect of radioiodine in nontoxic multinodular goiter.        2. Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant          human TSH for the effect of radioiodine on thyroid size and function in patients with a          very large (>100 ml) nontoxic or toxic goiter.        3. Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume          in healthy individuals? A randomized double-blind cross-over trial.        4. Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume          in healthy individuals and in patients with multinodular non-toxic goiter? A randomized          double-blind cross-over trial.           As a final note we investigate, in a pilot-study;        5. The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism          treated with continuous block-replacement therapy.   "
176096|NCT00145379|"     Patients suffering from diabetes through many years have a risk of developing late diabetic     complications including changes in eyes, kidney, vessels and nerves. Late complications can     be postponed or avoided when assuring a good diabetes control, i.e. sensible diet, exercise,     frequent blood glucose measurements and a good medical treatment.      Blood glucose regulation depends on two different factors i.e. the insulin need of the body     and the amount of insulin in the body. The amount of insulin, in blood, is decided by the     amount of insulin infused daily, whereas the insulin need depends on the patient's weight,     physical activity and diet. Overweight type 2 diabetes patients have a large insulin need and     especially this need is decisive for their development of diabetes. If these patients are     treated with Metformin, blood glucose decreases and the result is an easier weight loss for     the patient. Especially, when these patients take this drug, the development of late diabetic     complications, especially arteriosclerosis, can be avoided or postponed.      Whether these favourable effects of Metformin are also present in type 1 diabetic patients     remains to be fully clarified, but some studies have indicated that this is the case. This     results in a better regulation of diabetes on a smaller insulin dose than the one given to     the patients before.      Metformin probably takes effect by increasing the glucose uptake in muscles and by reducing     the hepatic glucose production. The drug usually has no side-effects, but some patients do,     however, suffer from abdominal pain, small tendency to nausea, loose defaecation and a     metallic taste in the mouth. These side-effects are often temporary.      Project description      In total, 50 type 1 diabetic patients are offered to participate in the project. All are from     the outpatient clinic at the Department of Endocrinology. The project lasts 7 months divided     as follows:        1. An introductory period of one month introducing an optimisation of the insulin treatment        2. A 6 month period (in which neither the patients nor the treating doctor know which          medication is given) with either T. Metformin treatment twice daily or T. Placebo (lime)          twice daily together with the usual insulin treatment four times daily.      Choice of either T. Metformin or T. Placebo will be made by draw, and as stated above, the     drug type will be unknown for both the patient and the treating doctor in order to make sure     that the investigation is as objective as possible.      Throughout the examination period, the patients are asked to measure blood glucose four times     daily, i.e. before main meals and before bed time. These values will be used for regulating     the fasting insulin dose with help from the treating doctor, and for adjusting the daily     insulin dose. During the first and the last two days of the examination period we will also     ask the patients to measure blood glucose at 03h00 for two days. Those diurnal profiles will     be included in the evaluation of the blood glucose control during the treatment period.     Furthermore, the patients' blood pressures are determined during 24 hours before and after     the 6 months' treatment period. This will be carried out automatically by means of a blood     pressure cuff around the arm connected to a small apparatus registering the values during 24     hours. The apparatus can be taken home after installation at the outpatient clinic and can be     carried around in a belt around the waist until next day where the apparatus will be     dismantled.      At the first and the last of 5 outpatient visits, blood tests will be taken (for evaluation     of the long-term blood glucose, kidney, liver, insulin and fat in blood) and nocturnal urine     must be collected and disposed in order to evaluate protein secretion and thereby kidney     function.   "
176097|NCT00145392|"     In this study, we will clarify the degree of insulin resistance and characterise muscle     glucose metabolism and gene expression in a group of overweight healthy women. The study will     clarify how overweight influences body glucose metabolism and thereby in the long-run     increases the risk for developing type 2 diabetes. Moreover, the study may clarify why some     overweight women develop hormone disorders and diabetes while others remain healthy.      The study is essential as many patients suffer from diseases aggravated by overweight. In     addition, a genetic disposition for diabetes or polycystic ovary syndrome may give rise to     the disease if the patient gains weight. It is therefore important that weight-matched     control subjects are included in projects with overweight patients.      This clinical trial includes 10 overweight women with regular hormones and normal level of     male sex hormone. The patients included must be healthy, take no medications influencing the     study results. The subjects must take no contraceptive pills or receive any other hormone     treatment.      In connection with the investigation, the following will be carried out on all patients:     clinical examination, blood tests, hyperinsulinaemic euglycaemic clamp, muscle biopsies, bone     scan.      The purpose of the study is to gain more knowledge of how overweight influences women's risk     of developing hormone diseases and diabetes.   "
176098|NCT00145405|"     The morbidity and the mortality in acromegalic patients closely correspond to growth hormone     (GH) levels and therefore efficient long-term treatment is important.      Neurosurgery is the first choice of treatment in acromegalic patients. Surgery normalizes GH     levels in about 80% of patients with microadenomas, but less than 50 % of patients with     macroadenomas respond sufficiently to surgery alone. In most patients, additional medical     therapy is therefore needed.      Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or     radiotherapy can not lead to normal GH and IGF-I levels. Lanreotide Autogel (LAN) is a new     formulation of lanreotide consisting of a prolonged release aqueous formulation, which can be     injected intramuscularly or deep subcutaneously once every 28 days.      Aim      The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and     IGF-I levels according to the 2000 Consensus. Furthermore, we wanted to evaluate which     treatment modality resulted in the lowest possible IGF-I and GH levels and the highest     patient satisfaction.   "
176099|NCT00145418|"     It has been accepted and proven that patients with unresectable lung cancer can benefit from     systemic chemotherapy. Traditional platinum-based therapy has significant side effects.     Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of     this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity     profile and to determine the response rate to this study drug combination.   "
176100|NCT00145431|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      To evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects     with a rare genetically known disorder of high cholesterol and triglyceride levels.   "
176101|NCT00145444|"     This study intends to compare novel antipsychotics ziprasidone and olanzapine, to confirm the     findings of an open study -where stable patients receiving olanzapine switched to     ziprasidone- which showed maintenance of clinical effect with improvements in all domains of     cognitive function at 6 weeks (Daniel, 1999). Direct comparison of the two agents in a     well-controlled double-blind fashion will allow an evaluation of the effect on cognitive     function in the short and long-term management of patients with recent-onset schizophrenia,     schizoaffective and schizophreniform disorder.   "
176104|NCT00145483|"     Meniere's disease affects a person's sense of balance. An attack can last 20 minutes to 2     hours or longer. Symptoms include rotational vertigo, hearing loss, tinnitus and a sensation     of fullness in the affected ear and may be associated with nausea and vomiting. One     hypothesis is that Meniere's disease is caused by the excessive accumulation of fluid in the     balance tubes within the inner ear. Sildenafil may alleviate the symptoms due to its     vasodilatory activity. The purpose of this study is to assess the safety and efficacy of     sildenafil (Viagra) compared with placebo on symptoms during one acute attack.   "
176105|NCT00145496|"     Treatment with conventional antipsychotics such as haloperidol has little effect or may     sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and     poor rapport) of schizophrenia. The newer atypical antipsychotics agents, such as     olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The     purpose of this study is to compare an investigational compound (asenapine) with a marketed     agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of     schizophrenia for 6 months. Patients completing this study may be eligible to participate in     an extension 6 months of treatment. Patients are required to have stable symptoms prior to     entry into study.   "
176106|NCT00145509|"     The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety     and tolerability of asenapine in bipolar I disorder subjects who had not completely responded     to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute     manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008     (NCT00145470). The safety comparison was between the group receiving lithium or VPA and     placebo against the group receiving lithium or VPA and asenapine, with the caveat that all     subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.   "
176107|NCT00145522|"     This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone     in comparison with tibolone on the breast metabolic markers, in particular the total     insulin-like growth factor-1 (IGF-1), in postmenopausal women.   "
176108|NCT00145535|"     Use of the Titanium Sapphire laser for laser trabeculoplasty to reduce intraocular pressure     in patients with poorly controlled intraocular pressure on maximally tolerated medical     therapy or prior failed laser trabeculoplasty.   "
176109|NCT00145548|"     The Spiration Intra-Bronchial Valve is intended for use as a minimally invasive treatment for     severe emphysema, using standard bronchoscopy. The valve is designed to limit airflow to a     selected portion of the lung, producing a reduction in lung volume, which may improve     pulmonary function in patients with emphysema.   "
176110|NCT00145561|"     Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women   "
176111|NCT00145574|"     This study will evaluate the lipid-lowering effect and safety of colesevelam therapy     administered to heterozygous familial pediatric patients 10 through 17 years of age who are     on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin,     simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.   "
176112|NCT00145587|"     Malignant infantile osteopetrosis (MIOP) is a rare fatal genetic disorder that is     characterized by the bone's inability to regulate remodeling. The only curative therapy is     hematopoietic stem cell transplantation. Stem cells provided from an HLA identical matched     sibling donor is the standard of care, but not feasible for the majority of patients. In     addition, due to the potentially rapid progression of this disease, the time to identify a     suitable HLA matched unrelated donor is not optimal. Therefore this study is designed to test     the hypothesis that children with osteopetrosis can properly engraft hematopoietic stem cells     that are donated from a partially matched parental donor, or haploidentical stem cell donor     that are processed on the investigational device, CliniMACS selection system.   "
176113|NCT00145600|"     With the success of current chemotherapy for Hodgkin's disease, the goal of this protocol is     to maintain the currently successful cure rate and reduce treatment related side effects and     long term toxicity. The main purpose of this study is to estimate the event free survival of     patients treated with risk-adapted therapy compared to historical controls.   "
176114|NCT00145613|"     Relapsed disease is the most common cause of death in children with hematological     malignancies. Patients who fail high-intensity conventional chemotherapeutic regimens or     relapse after stem cell transplantation have a poor prognosis. Toxicity from multiple     therapies and elevated leukemic/tumor burden usually make these patients ineligible for the     aggressive chemotherapy regimens required for conventional stem cell transplantation.     Alternative options are needed. One type of treatment being explored is called haploidentical     transplant.      Conventional blood or bone marrow stem cell transplant involves destroying the patient's     diseased marrow with radiation or chemotherapy. Healthy marrow from a donor is then infused     into the patient where it migrates to the bone marrow space to begin generating new blood     cells. The best type of donor is a sibling or unrelated donor with an identical immune system     (HLA match). However, most patients do not have a matched sibling available and/or are     unable to identify an acceptable unrelated donor through the registries in a timely manner.     In addition, the aggressive treatment required to prepare the body for these types of     transplants can be too toxic for these highly pretreated patients. Therefore doctors are     investigating haploidentical transplant using stem cells from HLA partially matched family     member donors.      Although haploidentical transplant has proven curative in many patients, this procedure has     been hindered by significant complications, primarily regimen-related toxicity including     graft versus host disease (GVHD), and infection due to delayed immune reconstitution. These     can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens     when the donor T cells recognize the patient's (the host) body tissues are different and     attack these cells. Although too many T cells increase the possibility of GVHD, too few may     cause the recipient's immune system to reconstitute slowly or the graft to fail to grow,     leaving the patient at high-risk for infection. However, the presence of T cells in the graft     may offer a positive effect called graft versus malignancy or GVM. With GVM, the donor T     cells recognize the patient's malignant cells as diseased and, in turn, attack these diseased     cells.      For these reasons, a primary focus for researchers is to engineer the graft to provide a T     cell depleted product to reduce the risk of GVHD, yet provide a sufficient number of cells to     facilitate immune reconstitution, graft integrity and GVM.      In this study, patients were given a haploidentical graft engineered to with specific T cell     parameter values using the CliniMACS system. A reduced intensity, preparative regimen was     used to reduce regimen-related toxicity and mortality. The primary goal of this study is to     evaluate overall survival in those who receive this study treatment.   "
176127|NCT00145782|"     The objective of The Ebeltoft Health Promotion Project is investigate the effect of     multiphasic preventive health screenings and discussions with general practitioners of a     random population of patients in primary care.      Outcome parameters are the cardiovascular risk profile, number of health care contacts, life     years gained, direct costs, i.e. health care costs, and total cost, i.e. including     productivity costs.   "
176250|NCT00149968|"     The purpose of this study is to assess whether a switch from mycophenolate mofetil (MMF) to     enteric-coated mycophenolate sodium (EC-MPS) results in improved GI- and/or health-related     quality of life outcomes, and to determine the proportion of renal transplant recipients who     are experiencing any GI complaints under MMF-based immunosuppressive treatment.   "
176115|NCT00145626|"     Recent studies of conventional chemotherapy for infants with high-risk hematologic     malignancies show that the long-term disease-free survival is low. Although blood and marrow     stem cell transplantation using an HLA identical sibling has improved the outcome for these     children, less than 25% have this donor source available. Another option is haploidentical     transplantation using a partially matched family member donor (i.e. parental donor).      Although haploidentical transplantation has proven curative for some patients, this procedure     has been hindered by significant complications, primarily regimen-related toxicity including     infection and graft versus host disease (GVHD). Building on prior institutional trials, this     study will provide patients a haploidentical graft depleted of T lymphocytes using the     investigational device, CliniMACS selection system. One week after the transplant procedure,     patients will also receive an infusion of additional donor derived white blood cells called     Natural Killer (NK) cells in an effort to decrease risks for rejection of the graft, disease     relapse, and regimen related toxicity. The primary objective of the study is to evaluate 1     year survival in infants with high risk hematologic malignancies who receive this study     treatment.   "
176116|NCT00145639|"     This trial (OS99) evaluates the use of ifosfamide, carboplatin, and doxorubicin in an     up-front window before surgery for localized and resectable osteosarcoma. High-dose     methotrexate, which may interfere with the dose-intensive delivery of other agents, is     eliminated from the treatment of localized disease. The primary objective is to compare the     response rate of pre-surgical chemotherapy comprised of ifosfamide, doxorubicin, and     carboplatin to that obtained with ifosfamide and carboplatin in the St. Jude OS-91 trial for     patients with non-metastatic resectable osteosarcoma. We hypothesize that the histologic     response rate will be improved by the addition of one course of pre-operative chemotherapy on     this trial compared to the previous OS-91 trial.   "
176117|NCT00145652|"     This is a multi-center open label, randomized phase-3 study with stratification according to     diagnosis and baseline serum-EPO level. The correction of mild or moderate anemia and the     effect on iron kinetics by the rHuEPO treatment with or without intravenous iron     supplementation in anemic patients with LPD not receiving antineoplastic therapy will be     studied. The study will be performed according to the ICH-GCP guidelines. In order to be     eligible, the patient must consent in writing that he/she agrees to participate in the study.     The patient recruitment period is estimated to be no longer than 18 months.   "
176118|NCT00145665|"     The aim of the study is to obtain information on FLT used in a PET-scan as a marker for the     proliferation of colorectal liver metastases, so that the risk of recurrence can be     identified in a noninvasive way, concerning patients with resectable colorectal liver     metastases.      The hypothesis of this study is that a higher uptake of FLT in the liver metastases has a     good correlation with the proliferation rate of the metastases. This rate is related to the     risk of recurrence.   "
176119|NCT00145678|"     The purpose of the study is to determine the feasibility and effectiveness of a modified form     of psychodynamic psychotherapy for persons suffering from co-occurring borderline personality     disorder and an alcohol use disorder.   "
176120|NCT00145691|"     We intend to conduct a phase III b trial to verify Oxcarbazepine's effect in agitation and     aggression in patients with dementia. We designed the study as a randomized, double-blind,     placebo-controlled multi center trial. Hundred patients will be included. The treatment     period will be eight weeks, with a further follow up of four weeks.      The primary outcome measure will be the reduction in aggression and agitation as measured by     means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home     Version). Secondary outcomes are reduction in aggression as measured by BARS (Behavior     Agitation Rating Scale)and reduction in the burden to health-care personnel as measured by     NPI-NH.   "
176121|NCT00145704|"     The purpose of this project is to evaluate the hypothesis that bisphosphonate treatment given     to growth hormone deficient patients (regardless of current growth hormone replacement     therapy status and without changing that status) significantly increases total body bone     mineral density during an eighteen month period of treatment combined with calcium and     Vitamin D when compared to calcium and Vitamin D treatment alone.   "
176122|NCT00145717|"     The aim of this study is to see if plant sterols are effective at lowering blood cholesterol     levels in Chinese people. The study will be done with Chinese colleagues based at Peking     University in Beijing with whom our Institute has a well-established collaboration. The study     will be randomised, placebo-controlled and double-blind. The total study period for     participants will be an average of seven weeks comprised of a two-week placebo run-in period     and a five-week follow-up on randomised treatment. Randomised treatment will comprise either     placebo, low- or standard-dose plant sterol. The primary outcome for the study will be blood     cholesterol levels.   "
176123|NCT00145730|"     The primary aim of this randomised trial is to determine the effects of a short     peri-operative course of treatment with a non-steroidal anti-inflammatory drug (NSAID),     ibuprofen, on the long-term consequences of ectopic bone formation in patients undergoing     elective total hip replacement surgery. The specific hypotheses to be tested at that 6 to 12     months after surgery, patients assigned post-operative ibuprofen will have less self-reported     pain and physical disability, greater health-related quality of life and reduced ectopic bone     formation compared with those assigned placebo.   "
176124|NCT00145743|"     Quality of Life-Diagnostics and -Therapy in Individual Patients with Breast Cancer.      A randomized study including 200 patients, 5 clinics and 43 general practitioners as     coordinating doctors for quality of life therapies.   "
176125|NCT00145756|"     Cardiovascular disease is a leading cause of death and disability worldwide, and blood     pressure is a leading determinant of this risk. To date, strategies for blood pressure     lowering have focused on drug treatment but dietary interventions such as reducing sodium     intake and increasing potassium intake may also be effective. Such interventions may be     particularly suitable for low- and middle-income countries in which significant dietary     changes may be more easily achieved. This study will test the effect of a salt substitute on     blood pressure, among individuals at high-risk from cardiovascular disease in Northern China.   "
176126|NCT00145769|"     This is a multi-centre randomised trial comparing long course (LC) preoperative     chemoradiation with short course (SC) preoperative radiotherapy for patients with localised     T3 rectal cancer.   "
176251|NCT00149981|"     Facilitated access to everolimus until it is commercially available and reimbursable by     appropriate parties   "
176128|NCT00145795|"     Our goal is to determine if a change in therapy to one containing Kaletra can improve the     immune response in patients who have previously been immune partial responders or     non-responders. We also are interested in knowing if this agent improves immune response by     affecting cluster of differentiation 4 (CD4) + T cell death (apoptosis) or by further     inhibiting (preventing) ongoing, low-level, viral replication to levels below detection by     current viral load measurements. This will help us understand why immune responses to     effective antiretroviral therapy are so different and help determine some possible guidelines     for managing patients with poor immune responses.      Hypothesis: Patients with poor immune responses to HAART who receive Kaletra in place of     their current PI or Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) while continuing     their current 2 NRTI backbone will have improved immune response to therapy compared to     patients who continue their current regimen.   "
176129|NCT00145808|"     Based on the inaccuracies of the current classification scheme for inflammatory bowel disease     (IBD), the failure of surgical pouches and the findings of retrospective observational trials     to date, we hypothesize that a significant proportion of patients with UC will have small     bowel involvement that will result in a change in diagnosis to CD or the recognition of a new     phenotype of IBD. The aim of this study is to determine the prevalence of small bowel     pathology in patients diagnosed with UC using WCE. This information will aid in the current     efforts to re-classify IBD using improved endoscopic and imaging technologies, genetic     information and serologic information.   "
176130|NCT00145834|"     The purpose of this study is to investigate if a postnatal public health breastfeeding     intervention relying on the importance of the psychosocial factors can prolong the period     with exclusive breastfeeding duration among mothers who want to breastfeed.   "
176131|NCT00145847|"     The primary purpose of this study is to determine whether naltrexone is effective in the     treatment of alcohol dependence and abuse in patients with schizophrenia and schizoaffective     disorder. Hypotheses are as follows:      hypothesis 1: Naltrexone will be more effective than placebo in reducing alcohol use.      hypothesis 2: Patients responding to naltrexone by reducing alcohol use will also show     reductions in severity of psychiatric symptoms and utilization of inpatient and emergency     psychiatric services.      hypothesis 3: Severity of psychiatric symptoms and amount of service utilization will     correlate positively with alcohol use.   "
176132|NCT00145860|"     The purpose of this study is to assess whether patients with colorectal cancer understand     that their first-degree relatives are at increased risk of getting the cancer themselves and     therefore should be screened early. Among patients who do understand the risks to their     family, we plan to determine who they identify as the source of their information and whether     they have acted upon this information and advised family members to be screened. We     hypothesize that many patients with colorectal cancer do not have a correct understanding of     the risks to their first-degree relatives and the recommendations that they be screened     early.      If this hypothesis is shown to be true, it can be used to direct improved and more diligent     patient education. This, in turn, will hopefully increase the low screening rates among     first-degree relatives, and, thereby, save lives in this high-risk population.   "
176133|NCT00145873|"     The purpose of this study is to look at the safety and effectiveness of longer term     intravenous (IV) infusion of the study drug, nesiritide in patients with acutely     decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human     hormone that dilates veins and arteries. Nesiritide (Natrecor) is currently FDA-approved for     short-term inpatient IV treatment of acutely decompensated chronic heart failure.      Hypothesis: Nesiritide, administered by continuous intravenous infusion in the outpatient     setting, is a safe treatment for refractory Class III & IV chronic heart failure due to     systolic or diastolic dysfunction, regardless of renal function when administered over a     12-week period.      Corollary #1: Nesiritide, when infused continuously over 12 weeks will improve the overall     condition of patients with chronic heart failure. These mechanisms include reducing     hospitalizations when compared with the previous six months, improving symptoms as measured     by the Minnesota Living with Heart Failure short questionnaire, and improving functional     capacity as measured by 6-minute walk testing.      Corollary #2: Nesiritide infusion will be associated with a statistically significant     decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving     placebo infusions.   "
176134|NCT00145886|"     The purpose of this study is to determine how treatment with a new medication, recombinant     human parathyroid hormone (rhPTH) affects calcium balance and bone strength.   "
176135|NCT00145912|"     The purpose of this research is to evaluate the feasibility of an interview between an     adolescent / young adult and a PCP (Primary Care Physician).   "
176136|NCT00145925|"     The purpose of this study is to provide information on the risks and benefits of routine     blood pressure lowering (regardless of blood pressure level), and intensive lowering of blood     glucose levels, in patients with Type 2 diabetes at high risk of cardiovascular events. The     major outcomes of the study will be cardiovascular events (heart attack, stroke or dying as a     result of cardiovascular disease), as well as new or worsening diabetic eye and kidney     disease.   "
176144|NCT00140166|"     Controlled studies using the orthomolecular approach have been few (Deutsch, Ananth, & Ban,     1977). Those that were done were performed in chronic schizophrenia or in populations that     included bipolar and schizoaffective patients. Both of these diagnostic groups are not today     considered to benefit from the orthomolecular approach. Moreover, some negative studies of     high-dose niacin were done in patients who were not otherwise given general counseling for     good diet as described above. Therefore, this proposal is to study in a controlled manner     carefully defined first onset schizophrenic patients using the protocol advocated by Osmond     and Hoffer (1962). Patients can enter the study if they have been ill less than 1 year and     are in their first hospitalization.   "
176170|NCT00140504|"     This is a study to better understand the nature and extent of adverse drug events (ADEs),     defined as injuries due to prescription medications, in primary care. We will study whether     PatientSite (an internet-based communication program for patients and health care providers)     can improve clinicians' ability to detect adverse drug events among primary care patients and     to mitigate the consequences by sending electronic queries to patients after they receive new     medication prescriptions.   "
176137|NCT00145938|"     The purpose of the study is to see if the administration of sildenafil (Viagra) in patients     with portopulmonary hypertension could be a safe and effective treatment.      Portopulmonary hypertension (PTPH) is a special type of pulmonary hypertension. Pulmonary     hypertension is high blood pressure in the pulmonary arteries that carry unoxygenated blood     from the right ventricle of the heart to the lungs. Pulmonary hypertension results from     constriction, or tightening, of the blood vessels that supply blood to the lungs.     Consequently, it becomes difficult for blood to pass through the lungs, making it harder for     the heart to pump blood forward. This stress on the heart leads to enlargement of the heart     and eventually fluid can build up in the liver and tissues, such as in the legs. Affected     patients can sometimes notice increasing shortness of breath and dizziness.      There is a growing body of evidence suggesting a potential therapeutic role for this     sildenafil in patients with primary pulmonary hypertension. Studies are ongoing regarding     this area.      Our hypothesis is that chronic oral sildenafil will successfully reduce pulmonary artery     pressures by at least 25% (reduction in mean pulmonary artery pressure) and could be an     effective treatment for PTPH, especially in candidates for liver transplantation      Primary Hypothesis To measure the effects of a single dose of sildenafil on pulmonary     arterial pressure in patients with PTPH      Secondary Hypothesis To measure the effects of chronic (3 month) treatment with sildenafil on     pulmonary arterial pressure, safety, and tolerability in patients with PTPH   "
176138|NCT00140075|"     The purpose of this study is to compare two combinations of drugs, epirubicin given with a     taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to     see if one of the combinations is better at preventing or delaying the time for breast cancer     recurrence and death after 3 years. The study will also evaluate the side effects of both     treatment combinations.   "
176139|NCT00140088|"     Minor needlestick procedures often cause significant pain and distress in pediatric patients     yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use,     prefilled, needle-free product that immediately delivers powdered lidocaine into the     epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III,     prospective, randomized, double-blind, placebo-controlled study is to investigate the     efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients aged 3     to 18 years undergoing venipuncture or peripheral venous canulation procedures. The trial     will enroll approximate 504 evaluable subjects at centers located in the US.   "
176140|NCT00140101|"     The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx     drug-eluting stent in patients with blockage of native coronary arteries. The study is     designed to demonstrate non-inferiority to the TAXUS Express2 Paclitaxel-Eluting Stent that     has proven superior to bare metal stents and is a recognized standard of care.   "
176141|NCT00140114|"     Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the     United States since 1988 as a gastric cytoprotective agent. In contradistinction to     prostaglandin E2 preparations (dinoprostone, Prepidil, Cervidil), misoprostol is inexpensive     and available in scored tablets that can be broken and inserted vaginally. Despite a focused     campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over     the past several years, gained widespread acceptance as both a labor induction and a cervical     ripening agent. Such off-label indication has been endorsed by the American College of     Obstetricians and Gynecologists and other medical bodies. Recently, FDA approved a new label     for the use of cytotec during pregnancy which removed pregnancy as a contraindication for its     use. Vaginal administration seems to be more efficacious than when given orally, although     there is the worry of uterine tachysystole and hyperstimulation with vaginal doses > 50-µg.     The use of sublingual misoprostol for cervical ripening at term was recently investigated in     two studies that compared it to the oral route, on the assumption that the sublingual route     would have the higher efficacy of the vaginal route by avoiding the first pass effects of the     gastrointestinal and hepatic systems, while having lower hyperstimulation rates by avoiding     the direct effects on the cervix. In addition, the sublingual route would combine an easier     administration with the added advantage of no restriction of mobility after administration.     There has been no previous report in the literature comparing the use of misoprostol given     sublingually to that given vaginally for the induction of labor at term. Our aim is to     compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the     current standard) to that given sublingually.   "
176142|NCT00140140|"     The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and     vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor     support with granulocyte colony-stimulating factor (G-CSF) (Patients with HER-2/neu positive     disease may receive Herceptin, and 2) determine the optimal tolerated dose of ABI-007 and     vinorelbine, given concurrently on a weekly basis, in the presence of planned growth factor     support with G-CSF.   "
176143|NCT00140153|"     The success of sildenafil in the treatment of erectile dysfunction has led to efforts to find     similar treatments for prevalent disorders of female sexual dysfunction. Daily transdermal     testosterone has been shown to improve sexual function in women after oophorectomy (Shifren     et al, Transdermal testosterone treatment in women with impaired sexual function after     oophorectomy, New England Journal of Medicine, 343; 682-8, 2000). In laboratory measures of     sexual arousal, a single application of transdermal testosterone enhanced vaginal blood and     increased erotic fantasy in normal volunteer women in the laboratory setting, four hours     after application (Tuiten et al, Can sublingual testosterone increase subjective and     physiological measures of laboratory-induced sexual arousal?, Arch Gen Psychiatry,     59;465,2002). We therefore planned a study of transdermal testosterone (25mg) marketed as     Androgel in female hypoactive sexual desire disorder. Patients are recruited from the     sexology clinics at Soroka Hospital and the Beersheva Mental Health Center. They are     randomized to Androgel or placebo and given 10 packets and instructed on application to the     abdomen and shoulders, four hours before planned intercourse. Patients unable to discuss     planned intercourse with their partner are offered psychosexual counseling and those still     unable after three sessions are excluded. After one month patients on active Androgel are     crossed over to placebo or vice versa. Patients self-rate sexual response after each     intercourse using the Brief Index of Sexual Functioning for Women, and Arizona Sexual     Experiences Scale (ASEX)-Female and are rated in interview at the end of each month of     treatment using the Sexual Function Questionnaire (SFQ-V1). Our prn technique avoids the     androgenizing side effects of continuous daily treatment.   "
176169|NCT00140491|"     The goal of this pilot study is to evaluate the effect of Vision Restoration Therapy, VRT, on     the visual function of patients with unilateral or bilateral AION, who have good central     vision (at least 20/60) and altitudinal visual field defects.   "
176311|NCT00150774|"     A double-blind, placebo-controlled study to assess the efficacy of adjunctive treatment with     LEV 3000mg/day in reducing myoclonic seizures in adolescents and adults suffering from     idiopathic generalised epilepsy and to evaluate the safety of LEV in the same population.   "
176145|NCT00140179|"     Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its     well-known teratogenicity limits its use in young women of childbearing age. According to     toxicologic studies the teratogenicity of valproate stems from its free carboxylic group.     Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does     not undergo a biotransformation to the corresponding free acid. It is also likely or at least     possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be     distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only     1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice).      The investigators are performing a double-blind controlled trial of valnoctamide as an     anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate     substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly     admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and     Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or     schizoaffective disorder, manic type. Patients admitted to the study are treated with     risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2.     Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and     increased to 1200 mg (400 mg three times daily) after four days.      Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief     Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global     Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas     chromatography. Each patient receives valnoctamide or placebo for 5 weeks.      Low teratogenic mood stabilizers are a high priority for current research.   "
176146|NCT00140192|"     Creatine plays a pivotal role in brain energy homeostasis. Creatine supplementation is widely     used in enhancing sports performance, and has been tried in the treatment of neurological,     neuromuscular and atherosclerotic disease with a paucity of side effects.      Dechent et al (1999) studied the effect of oral creatine supplementation for 4 wk     demonstrating a statistically significant increase of mean concentration of total creatine     across brain regions. These findings suggest the possibility of using oral creatine     supplementation to modify brain high-energy phosphate metabolism in subjects with various     brain disorders, including schizophrenia and major depression. Recently, Rae et al (2003)     reported that creatine supplementation for 6 weeks had a significant positive effect on both     working memory and Raven matrices. Several independent lines of evidence suggest the possible     involvement of altered cerebral energy metabolism in schizophrenia.      We are performing a double blind cross-over study of creatine in schizophrenia.      Forty patients will be treated with creatine for 3 months in a double-blind crossover design.     Rating scales will include scales for assessing negative and positive symptoms of     schizophrenia, clinical global impressions scale, scales for side-effects and a cognitive     battery      Creatine effects on brain energy metabolism and its possible cognitive enhancing properties     raise the possibility of developing a new therapeutic strategy in schizophrenia focusing on     treating metabolic hypoactive brain areas including frontal regions.   "
176147|NCT00140205|"     The purpose of this study will be to determine the correct dose of leptin, a natural hormone     secreted by the fat cells, to give to people when they are fasting and also to determine     whether giving leptin to a person when he or she is fasting will reverse the changes in     hormone levels that occur with fasting.   "
176148|NCT00140218|"     The hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter     the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients     at an early stage of disease will be observed for 3 months after enrollment and then treated     with drug for 6 months.   "
176149|NCT00140231|"     The purpose of this study will be to determine whether giving leptin (r-metHuLeptin) to a     person when he or she is fasting will reverse changes in metabolism, and hormone levels, and     immune function associated with fasting, which decreases leptin levels.   "
176150|NCT00140244|"     The purpose of this study is to examine whether replacing leptin to normal levels can reverse     the changes in fat distribution, lipid profile, and other metabolic problems associated with     highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in     HIV patients.   "
176151|NCT00140257|"     Objective: To evaluate the efficacy of preventive treatment with a selective serotonin     reuptake inhibitor (SSRI) (escitalopram) in the first year after acute coronary syndromes     (ACS).      Methods: 240 patients with acute coronary syndromes (ST-elevation myocardial infarction     [STEMI]), non-STEMI or unstable angina) will be enrolled within 8 weeks after ACS and will be     randomly assigned to treatment with escitalopram/placebo (5-20 mg) in 52 weeks. Primary     outcome measures are the diagnosis of depression and HDS (Hamilton Depression Scale).     Psychiatric measurements: SCAN (Schedules for Clinical Assessment in Neuropsychiatry), HDS,     HAS (Hamilton Anxiety Rating Scale), Udvalg for Kliniske Undersogelser (UKU) Side Effect     Rating Scale, ESSI (Enhancing Recovery in Coronary Heart Disease [ENRICHD] Social Support     Instrument), SF-36 (Short Form-36 Health Survey), SCL-92 (Symptom Check List) and BDI (Beck´s     Depression Inventory). Cardiological measurements are blood pressure, electrocardiography,     echocardiography (left ventricular ejection fraction), heart rate variability and use of     medicine.      Discussion: ACS patients with mental illness are usually only diagnosed to a very small     extent during admission in a cardiologic department. These patients mainly remain untreated     with an increased risk of somatic comorbidity and mortality. Therefore, it is in accordance     with ethical principles to conduct a double blind, placebo-controlled study investigating the     interface between anxiety, depression and ACS. Even in this blinded study, where one of the     groups are treated with placebo, there will be a higher degree of treatment of depressive     symptoms due to the low recognition of this problem.      Conclusion: The DECARD study is the first study evaluating the effect of prophylactic     treatment of depression in patients with ACS. The study will show if prophylactic treatment     will improve cardiac prognosis.   "
176152|NCT00140270|"     This research study involves implementing and evaluating a physical training program     specifically designed to reduce the risk of ligamentous knee injuries in female soccer     players by incorporating proven neuromuscular and proprioceptive training concepts into a     concise, on-field warm-up activity. All 283 Division I NCAA women’s soccer teams were asked     to participate in this research study. Those that agreed were randomized to control (usual     training program) and intervention (alternative warm-up program). Both groups of teams     provided investigators with participation and knee injury information during the 15 week 2002     fall soccer season. Requested information included only that which would be readily available     to the certified athletic trainers (ATC) in their normal course of duties. The knee injury     rates among intervention team athletes were compared with control team athletes to determine     program effectiveness. Data collection is complete and the report should be submitted shortly     for publication.   "
176153|NCT00140283|"     There is a great variability in the different primary care teams referral rate. And     variability means inappropriateness somewhere in the process of care. The most important     determinants of the variability are the attitude and knowledge of the professional, the     existence and availability of evidence, the resources available and the professionals     practice style. To improve the knowledge of the professionals could be a way to decrease the     variability. Because of this, we have the aim to determinate the effectiveness of an     educational intervention to improve the primary care teams from the city of Barcelona     referral rate.   "
176154|NCT00140296|"     Consistent and correct use of an effective contraceptive method is a primary determinant in     preventing pregnancy. Unfortunately, only a minority of healthcare providers adequately     address women’s contraceptive needs. We have developed a standardized behavioral-based     contraceptive counseling model that can be used by providers and other clinic staff to     address this limitation. The model, ESP, is an adaptation of motivational interviewing and     involves: Exploring discrepancies between pregnancy intention and contraceptive use and     between risk of STDs and condom use; Sharing information; and Promoting behaviors to reduce     risk.      Study question: Does ESP counseling lead to an increase in consistency and effectiveness of     contraceptive use among women at risk of unintended pregnancy?      Methods: Randomized controlled trial of 747 women, ages 16-44, at self-identified risk of     unintended pregnancy enrolled from March 2003 to September 2004 at healthcare settings in     North Carolina. Intervention participants received individualized ESP counseling from a     health educator to address barriers to effective and consistent contraceptive use. Risk     reduction steps were negotiated. Pregnancy, Chlamydia infection and contraceptive use were     assessed at baseline and follow-up. “Highly effective” contraceptive use was defined as a     combination of effectiveness and consistency. Women in the control arm received general     preventive health counseling (e.g., smoking and exercise). Differences between the study arms     at 12-months may illustrate the longer term influence of the intervention.   "
176155|NCT00140309|"     This study is a placebo-controlled factorial study, randomized to study drug (moxifloxacin     vs. ethambutol) and treatment frequency (daily vs. thrice weekly after an initial two weeks     of daily therapy) during the first two months of standard treatment (with isoniazid,     rifampin, and pyrazinamide) for sputum smear-positive pulmonary tuberculosis.   "
176156|NCT00140322|"     A randomized controlled trial to assess the effectiveness of an at-home comprehensive     approach to preventing falls among adults 65 years and older at high risk for falls.   "
176157|NCT00140335|"     The purpose of this study is to determine the effects of a commercial hand washing promotion     program on hygiene knowledge, attitudes, and practices, and on health outcomes such as     reported infectious illnesses and school absences.   "
176158|NCT00140348|"     The purpose of this study is to evaluate clinical and laboratory safety in patients receiving     4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated     dose.   "
176159|NCT00140361|"     This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which     is the current national treatment of choice for uncomplicated malaria in Tanzania, and a     combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania.      Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified     first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited     basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether     treated bednets would reduce confounding by reinfection   "
176160|NCT00140374|"     The objective of this study is to evaluate the safety and efficacy of priming vaccinations,     and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical     observations and laboratory measurements will be monitored to evaluate safety and toxicity.     Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels,     will be evaluated and antitumor responses will be quantitated.   "
176161|NCT00140387|"     The objective of this study is to evaluate the safety and efficacy of priming vaccinations,     and subsequent boosting vaccinations with Human GM-CSF Gene Transduced Irradiated Prostate     Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®). Clinical observations and     laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the     antitumor effects of Allogeneic Prostate GVAX® on serum PSA levels will be evaluated and     antitumor responses will be quantitated.   "
176162|NCT00140400|"     The objective of this study is to evaluate the safety and efficacy of a prime-boost dose     schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine     (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and     tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease     progression as well as local and systemic immune responses to the vaccine.   "
176163|NCT00140413|"     Hypotheses:        1. The prevalence of endocrinopathies, and growth hormone (GH) deficiency in particular,          among young children diagnosed with optic nerve hypoplasia (ONH) is higher than is          commonly thought.        2. Early treatment of children with ONH and GH-deficiency can prevent adverse outcomes.      Aims:        1. Determine the prevalence and types of endocrinopathies in children diagnosed with ONH.        2. Correlate endocrine outcome with radiographic, ocular, and developmental findings in          children with ONH.        3. Examine the effect of GH treatment on growth and obesity in children with ONH,          GH-deficiency, and either subnormal or normal growth compared to children with ONH that          are not GH-deficient.        4. Compare growth outcomes between children with isolated GH-deficiency and those with          multiple hormone deficiencies.   "
176164|NCT00140426|"     The aim of this pilot study is to determine the safety and efficacy of risperidone for the     treatment of anorexia nervosa.      Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image     distortion and Eating Disorder Inventory -2 scores than subjects on placebo.      Hypothesis 2: Subjects on risperidone will reach and maintain at or above 90% Ideal body     weight sooner than controls.   "
176165|NCT00140439|"     Little is known about how ED-based programs can help to reduce pediatric ED visits for     asthma. The current study evaluated a novel intervention in which the ED itself became the     site of highly individualized, comprehensive follow-up asthma care. It sought to determine if     such an intervention could decrease subsequent unscheduled visits for asthma while improving     asthma quality of life.   "
176166|NCT00140452|"     The use of Thalidomide in patients with ALS who have disease progression.   "
176167|NCT00140465|"     The purpose of the study is to test whether an increase of the maintenance dose of     clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced     platelet aggregation   "
176168|NCT00140478|"     The purpose of this study is to determine the effects (good and bad) that mifepristone has on     patients with androgen independent prostate cancer.   "
176312|NCT00150787|"     A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse     events reporting, physical and neurological examination and vital signs   "
176171|NCT00140517|"     Plasmodium falciparum resistance to chloroquine (CQ) and sulfadoxine-pyrimethamine (SP)     continue to spread, impeding control of this important disease. CQ and SP are still the most     commonly used antimalarial drugs for malaria prevention during pregnancy and might be made     less effective by resistance. However, the treatment and prophylaxis regimens used may also     create conditions for selecting resistant malaria parasite strains. A better understanding of     the relationships between chemoprophylaxis regimens and resistance would be helpful to     improve chemoprophylaxis of malaria in pregnancy.      This work aims to improve the use of chemoprophylaxis in pregnancy by determining whether     there is a relationship between the use of standard prophylactic regimens with CQ and SP and     the occurrence of P. falciparum resistant strains in pregnant women. The study consists of 2     parts. The first part is a randomized trial comparing 3 chemoprophylactic treatment groups: -     weekly CQ after initial presumptive CQ treatment, - CQ intermittent presumptive treatment     given as a standard dose at 2nd and 3rd trimester, respectively and SP intermittent     presumptive treatment given as a single dose at 2nd and 3rd trimester, respectively. These     treatment groups will also be compared to a group of women delivering at the same health     centre but who have not been participating in the study. The second part will be a clinical     trial for assessment of clinical and parasitological efficacy of CQ and SP treatment in     pregnant women presenting with uncomplicated malaria attacks.      The study will be conducted from October 2002 to March 2005 in a health centre of     Ouagadougou, Burkina Faso where malaria transmission is seasonal and resistance to CQ and SP     is low.   "
176172|NCT00145951|"     The purpose of this research study is to assess the feasibility of a combined primary     care/web-based depression prevention intervention. Primary care physicians (PCP) currently     lack an alternative behaviorally-based approach to antidepressant medications for individuals     with depression symptoms or minor depression, but who have not yet developed Major     Depression.      The objective of this study is to compare the feasibility and efficacy of motivational     interviewing (MI) versus brief advice in primary care to engage adolescents with a web-based     depression prevention intervention.   "
176173|NCT00145964|"     Primary biliary cirrhosis (PBC) is a disease of the liver, which predominantly affects women.     It causes slowly progressive liver disease, which eventually causes liver failure, requiring     a liver transplant. Several different studies of large patient cohorts indicate that the     cause of this disease is likely due to a combination of factors including genetic and     environmental. PBC is associated with several other autoimmune diseases - recently a gene     has been identified to be abnormal in individuals with another autoimmune liver disease,     namely rheumatoid arthritis. This gene usually tells the body when to switch off an immune     response. This study plans to identify whether individuals diagnosed with PBC have a similar     abnormality in this gene called protein Tyrosine Phosphatase.   "
176174|NCT00145977|"     The purpose of this study is to determine if a new test for osteoporosis can be useful in     monitoring treatment. We are studying a new method for examining the quality of bone by an     experimental method of computerized analysis of radiographic images (x-ray pictures) of the     heel.   "
176175|NCT00145990|"     To determine whether there is a difference in two different breathing tests used to detect     asthma. Hypothesis: The Digidoser delivers less methacholine to the airways and will result     in a higher PC20 than the value determined by the Rosenthal Dosimeter.   "
176176|NCT00146003|"     The purpose of this study is to demonstrate a measurable improvement on a validated scale in     a small population of adult patients with atopic dermatitis (eczema).   "
176177|NCT00146016|"     * Adding Amantadine to standard anti-viral treatment can improve sustained response rates in     patients with chronic hepatitis C   "
176178|NCT00146029|"     The purpose is to examine the original breast tumor material to see how much of a     metabolizing enzyme (CYP3A4) is present in tumor material. The researchers want to see if     this is in any way associated with how the patient responded to docetaxel. They also want to     examine the genes in the tumor that are responsible for the production of CYP metabolizing     enzymes, to see if they are normal or if they have polymorphisms, or change compared to     'normal' CYP metabolizing enzymes.   "
176179|NCT00146042|"     This is a research study which aims to improve the way that doctors determine the dose of     chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height     and weight. However, some patients metabolize chemotherapy faster or slower than the average     person because of a different level of drug metabolizing enzyme in the liver. Therefore, some     patients are either given too small or too large a dose of chemotherapy because the amount of     enzyme is not taken into account. This research study will examine the use of a simple test,     call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can     metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored     to the amount of enzyme which is available to metabolize the drug for each patient. The drug,     docetaxel, is combined with another drug, trastuzumab (Herceptin), because at this time this     combination appears to be promising in metastatic breast cancer research.   "
176180|NCT00146055|"     The purpose of this study is to determine whether a less-intensive preparative therapy     followed by an allogeneic peripheral stem cell transplantation will provide an effective     treatment for your disease and whether it will be associated with fewer side effects.   "
176181|NCT00146068|"     The purpose of this study is to determine the safety, tolerability and efficacy of a     combination therapy interferon beta-1a(Avonex) plus simvastatin (Zocor) vs. interferon     beta-1a plus placebo in patients with clinically isolated syndrome suggestive of Multiple     Sclerosis.   "
176225|NCT00149630|"     Previous research has shown that disulfiram, a medication sometimes used for treating     alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone     treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases     levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in     cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug     relapse among cocaine and opiate addicts with varying inherited levels of DBH.   "
176226|NCT00149643|"     Adolescents who are diagnosed with major depressive disorder are often also diagnosed with     marijuana dependence. Fluoxetine is an antidepressant medication currently used to treat     young people who are diagnosed with major depressive disorder. The purpose of this study is     to determine the effectiveness of fluoxetine in treating adolescents and young adults     diagnosed with both major depressive disorder and marijuana dependence.   "
176182|NCT00146081|"     Our long-term goal is to identify new insights about effective approaches to obesity     management and related lifestyle changes in African Americans and about factors that enhance     or limit the response to specific treatment approaches. Our primary interest is in natural     social support from family members or friends. However, since not all individuals seeking     obesity treatment desire or are able to name family members or friends to participate with     them, we will also study the benefits of social support by creating a team condition among     individuals recruited alone.      Specific aims are to:        1. Recruit overweight or obese index participants together with 1 or 2 family members or          friend co-participants who are also overweight or obese, for enrollment in a 2 year          weight loss program;        2. Conduct a randomized comparison of the effects, on weight loss and related behavioral          and clinical outcomes of the index participants, of involving both index and          co-participants (Group A) in the counseling program with those obtained when          co-participants are not directly involved (Group B);        3. Enroll otherwise eligible index participants who do not name co-participants in a          parallel 2 year weight loss study; Conduct a randomized comparison of the effects, on          weight loss and related behavioral and clinical outcomes of individual participants, of          creating social support teams of unrelated individuals (Group C) with those obtained          when no such teams are created (Group D).      Primary hypotheses are that:        1. weight loss from 0 to 12 months and from 0 to 24 months will be significantly greater in          Group A vs. Group B;        2. weight maintenance from 12 to 24 months will be significantly greater in Group A vs.          Group B;        3. weight loss from 0 to 12 months and from 0 to 24 months will be significantly greater in          Group C vs. Group D;        4. weight maintenance from 12 to 24 months will be significantly greater in Group C vs.          Group D. Secondary analyses will compare the respective treatment and control groups on          changes in diet, physical activity, and clinical CVD risk factor changes over time and          will assess predictors of outcomes and cost-effectiveness.   "
176183|NCT00146094|"     Osteopenia and osteoporosis are increasingly reported in HIV-infected patients, and appear to     be more frequent than in general population. However, pathogenesis remains unclear, and     published studies still give non concordant results.      We therefore started a prospective study, to assess the potential role of ARV in the     occurrence of osteopenia and osteoporosis. BMD evolution over a 2-years period of follow-up,     will be compared between patients starting ARV therapy, and subjects without HAART (no     indication of treatment). A correlation between BMD and several factors will be looked at     (see below).      This study with individual direct benefice, is conducted in 3 outpatients clinics     (Strasbourg, Colmar, Mulhouse) in collaboration with the rheumatologic teams. 60 patients are     planned to be included over a 3-years inclusion period   "
176184|NCT00146107|"     The purpose of this study is to determine the effect of weight loss and exercise on physical     function, body fat and muscle mass, bone strength, and quality of life.   "
176185|NCT00146120|"     The concept of the investigators risk-adapted multicenter treatment trial for younger adults,     AML HD98A, is based on the results of the AML HD93 trial and on published data. Definition of     risk groups is different compared to the AML HD93 trial; high-risk: refractory disease after     first induction therapy and/or high risk karyotype [abn(3q), -5/5q-, -7/7q-, abn(12p),     abn(17p), complex]; intermediate-risk: complete remission after induction therapy and     intermediate risk karyotype [normal, abn(11q23), abn(16q22), other rare aberrations];     low-risk: complete remission after induction therapy and low risk karyotype [t(8;21)].     Patients exhibiting a t(15;17) were treated in a separated trial (APL HD95). Treatment     consists of a first induction therapy with ICE followed by a second cycle ICE in case of     response to first induction therapy. Patients with refractory disease after first induction     therapy are assigned to a salvage therapy with A-HAM (all-trans retinoic acid, high-dose     cytarabine and mitoxantrone) and the search for potential hematopoietic stem cell donors is     extended from the family to unrelated persons. All patients achieving a CR after induction     therapy with ICE are assigned to a first consolidation therapy with HAM. For     intermediate-risk patients a peripheral stem cell or a bone marrow harvest are intended     during the hematological recovery after the first consolidation. Second consolidation therapy     was stratified according to the risk definition. For high risk patients a allogeneic     transplantation is assigned from a related or unrelated donor preferentially after a     dose-intensified conditioning therapy. All patients with intermediate risk and an HLA-matched     family donor are assigned to allogeneic transplantation. Intermediate-risk patients without a     family donor and normal karyotype at diagnosis are randomized between an autologous stem cell     transplantation and a second course of HAM. The other intermediate-risk patients are assigned     to autologous transplantation. For low-risk patients a second course of HAM is assigned.   "
176186|NCT00146133|"     The overall purpose of this research is to determine the effect of weight loss and physical     training on quality of life, physical function, metabolism, bone strength, body fat and     muscle mass.   "
176187|NCT00146146|"     The purposes of this study are:        -  to determine the role of testosterone versus dihydrotestosterone with respect to the          following physiological functions: bone metabolism, body composition, insulin resistance          and lipid profile        -  to determine the role of testosterone and dihydrotestosterone versus estradiol with          respect to the following physiological functions: bone metabolism, body composition,          insulin resistance and lipid profile   "
176188|NCT00146159|"     The purpose of this study is to show the dose-response relationship of three doses of     mitoxantrone with regard to efficacy in patients with secondary progressive multiple     sclerosis and to show the safety and tolerability of mitoxantrone in these patients.   "
176189|NCT00146172|"     The purpose of this study is to evaluate the safety and tolerability as well as find the     maximum tolerated dose for HKI-272. In addition, this study will examine the effects of the     study drug on your tumor, and how your body uses and eliminates HKI-272.   "
176190|NCT00146185|"     Minor needlestick procedures often cause significant pain and distress in pediatric patients     yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use,     prefilled, needle-free product that immediately delivers powdered lidocaine into the     epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III,     prospective, randomized, double-blind, placebo-controlled study is to investigate the     efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients aged 3     to 18 years undergoing venipuncture or peripheral venous canulation procedures. The trial     will enroll approximate 504 evaluable subjects at centers located in the US.   "
176191|NCT00146198|"     Hernia repair is one of the most common operations. Whilst there are few complications, pain     may last for several weeks and extend the period of convalescence. ALGRX 4975 is an     ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term     pain relief following a single administration. This study will determine whether ALGRX 4975     can provide pain relief following hernia repair.   "
176192|NCT00146211|"     This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement)     signs and symptoms of Huntington disease.   "
176193|NCT00146224|"     The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is     equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD     receiving hemodialysis   "
176227|NCT00149656|"     The purpose of this trial is to determine whether supplementation with multivitamins and     selenium will delay disease progression in HIV infected individuals in Botswana. The study     will also assess how drug abuse modifies the effect of nutritional supplementation on HIV     disease progression.   "
176248|NCT00149929|"     Aim of study is to collect long term safety and tolerability data on enteric-coated     mycophenolate sodium with regard to adverse events, serious adverse events, and patient and     graft survival. After successful completion of study CERL080A301 study, patients who     previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to     remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated     mycophenolate sodium.   "
176194|NCT00146237|"     About two-thirds of depressed patients respond to a standard course of serotonin specific     reuptake inhibitor (SSRI's) within 3-4 weeks. While some clinicians advise continued watchful     waiting after this time or switch to a different reuptake-blocker based antidepressant,     result of such conservative strategies are usually disappointing. For severe depression     electroconvulsive therapy (ECT) is an option and for atypical depressions monoamine oxide     inhibitors (MAO) inhibitors often give relief at this point. A unique strategy with both     theoretical and practical implications is lithium augmentation (Fava et al, 1994). Addition     of lithium to SSRI failures at 3-4 weeks is consistently and sometimes dramatically found to     be helpful. This is considered true even by those authors who advocate use of lithium under     usual circumstances only in bipolar patients.      Lithium in recent years has been joined as a mood stabilizer by carbamazepine and valproate.     Phenytoin, ignored for many years as a possible anticonvulsant mood stabilizer, has been     recently reported in double-blind controlled trials to be anti-manic (Mishory et al, 2000)     and also prophylactic in BP disorder (Mishory et al, 2003).      Data on mood stabilizers other than lithium as augmentors in SSRI failures are sparse.     Carbamazepine (Steinacher et al, 2002) and valproate (Barbee et al, 2002) have been used.     Given our recent preliminary results of phenytoin's efficacy in unipolar depression (Nemets     et al, 2005) and its analogy to lithium as a mood stabilizer, it seems important to study     phenytoin as a possible augmentation of SSRI failures.      We have published a negative study previously of inositol as an augmentation of SSRI     failures, enrolling forty-two patients over two years (Nemets et al, 1999). Antidepressant     failures are easier to recruit from referring physicians in our center than are untreated     patients, whom clinicians are reluctant to refer for new drug studies given the adequacy of     standard treatment in 2/3 of them. Thus we estimate that we could enroll 20 patients per year     in such a study. Survey of the literature of Li augmentation suggests that 40 phenytoin vs.     40 placebo should give adequate power to detect a significant phenytoin effect if the     phenytoin effect is similar to that of lithium.   "
176195|NCT00146250|"     Nitrous oxide is a standard part of most anaesthetic breathing mixtures. It has often been     assumed that it reduces the amount of oxygen reaching the lower parts of the lung. However     the results of previous studies and of some computer modelling suggests the opposite may be     true, and that oxygen levels in the blood are actually higher with nitrous oxide. This study     seeks to determine whether nitrous oxide increases or decreases blood oxygen levels in     anaesthetized patients.   "
176196|NCT00146263|"     Background:      The aging of the population has lead to a significant increase in the number of older people     suffering from cognitive impairment and dementia. The present lack of effective drug therapy     for these conditions makes it imperative to investigate other potential therapeutic     interventions.      Cognitive training has been described as possibly useful in improving cognitive function in     elderly subjects with mild impairment and early dementia. However, there have been few     well-designed studies to date and the results are equivocal. Most studies have relied on the     use of paper-based neuropsychological assessment instruments with limited accuracy and     reproducibility. The investigators have developed a validated computerized neuropsychological     assessment battery with increased test-retest reliability.      The purpose of this study is to assess the efficacy of a computerized training program on     cognitive function in older persons with normal cognition, mild cognitive impairment, and     early dementia.      Description:      A randomized prospective AB/BA crossover study.      Methods:      Eligible males and females aged 60 years and older following initial computerized     neuropsychological assessment will be randomized to receive either a 12-session computerized     cognitive training program, or no treatment. Repeat neuropsychological assessment will be     followed by a 4-week no treatment phase, reassessment and crossover phase. Repeat assessments     will be performed at three and six months.   "
176197|NCT00146276|"     Primary Objective:        -  To analyse time to tumor progression in patients cystectomized for locally advanced          transitional cell carcinoma (TCC) of the bladder, who are not suitable for          cisplatin-based chemotherapy (i.e. postoperative reduced renal function, advanced age).          Patients are randomized to receive either adjuvant gemcitabine immediately after radical          operation (treatment arm A) or no treatment (control arm B). Patients in the control arm          are to be treated with gemcitabine as soon as tumor progression becomes evident          clinically and/or radiologically.      Secondary Objectives:      The secondary objectives of this study are:        -  Estimation of time-specific survival probabilities irrespective of causes of death.        -  Assessment of toxicity and tolerability of gemcitabine        -  Description of survival experience of patients in the control arm beyond the time of          initiating chemotherapy.        -  Assessment of quality of life (European Organization for Research and Treatment of          Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30).      Study Design:      This is an open-label, prospective, multicenter, randomized, controlled phase 3 two-arm study     using gemcitabine as a single agent in chemonaive cystectomy patients with locally advanced     TCC of the bladder in an adjuvant setting. The patients will receive the following treatment:      Arm A (treatment): gemcitabine 1250 mg/m2 intravenously once a week for 2 weeks (days 1 and     8) followed by 1-week rest period. Repeat cycle on day 22. Maximum of 6 cycles. Begin     treatment until 3 months after radical operation (within first 6 weeks is recommended).      Arm B (control): No immediate post-surgery treatment. Watchful waiting; treatment only     conditionally in case of progression with gemcitabine (dose and schedule as in arm A).   "
176198|NCT00149279|"     To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative     gastrectomy   "
176199|NCT00149292|"     Assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic     activity) in the treatment of schizophrenia.      The primary objective of this study is to determine if a mGlu2/3 agonist dosed for 28 days is     superior to placebo in the treatment of patients with schizophrenia as measured by the     Positive and Negative Symptom Scales (PANSS) total score.   "
176200|NCT00149305|"     Gouty diathesis describes uric acid or calcium oxalate nephrolithiasis and low urinary pH     (<5.5). A hereditary component has been outlined for several forms of nephrolithiasis (such     as hypercalciuria, hyperoxaluria, cystinuria, renal tubular acidosis), leading to the     hypothesis of a genetic predisposition to nephrolithiasis. At the Unit of Nephrology,     Ospedali Riuniti di Bergamo, more than 100 patients affected by gouty diathesis are followed.     Fifty percent of them has a familiarity for kidney stones formation. The aim of our study is     to identify the genetic factors that predispose to the development of nephrolithiasis in     patients with gouty diathesis.   "
176244|NCT00149877|"     Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of     subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to     investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients     with CC.   "
176249|NCT00149942|"     This open, single arm, explorative study aims to investigate the evolution of     gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted     patients suffering from gastrointestinal adverse events while on MMF therapy.   "
176201|NCT00149318|"     Fabry disease is an X-linked rare metabolic disease, caused by a deficient activity of the     hydrolase α-Galactosidase A, and characterized by a progressive and systematic deposition of     glycosphingolipids in many organs.      The disease is most severe in affected males. In the classic form (where the enzyme activity     is absent) the clinical findings are represented by pain and paresthesias in the extremities,     vessel ectasia (called angiokeratoma) in skin and mucous membranes, and hypohidrosis (a     reduced sweating) during childhood or adolescence. Corneal and lenticular opacities may be     present. Proteinuria, renal impairment,cardiac and neurological lesions develop with time,     together with hypertension. When end stage renal disease occurs, dialysis or renal     transplantation may be necessary. In heterozygous females a residual enzymatic activity may     be demonstrated and they usually have asymptomatic or later onset disease manifestations,     although rarely they could develop a disease as severe as in males.      A cardiac and a renal variant, where the heart and kidney are the only organs involved by the     disease have been described too.      The recombinant human α-galactosidase A is now available for patients. Infusions of the     enzyme replacement treatment have been demonstrated to be safe and effective. This study     wants to evaluate the long term efficacy of enzyme replacement therapy in patients with Fabry     disease and renal involvement.      Clinical period evaluations together with a genetic counselling will be offered to each     patient.   "
176202|NCT00149331|"     This study compared the impact of two educational strategies (an education program versus a     pamphlet) on participants preferences for insulin and their perceptions about insulin and     injections after attending an educational session with a diabetes educator about insulin.      Main research question: Among adults with type 2 diabetes who are potential candidates for     insulin therapy, does an education strategy that involves a personal letter from the family     physician, a presentation about insulin, and information about giving an injection, versus a     pamphlet education strategy, effect: preference to accept insulin therapy; perceptions about     insulin therapy; or perception about the injection?   "
176203|NCT00149344|"     Main research question: Is vertical scar reduction mammoplasty superior when compared to     inferior pedicle reduction mammoplasty in terms of patient quality of life and     cost-effectiveness?      Why is this research important?: There is on-going controversy among plastic surgeons as to     the superiority of one technique (vertical scar mammoplasty versus inferior pedicle reduction     mammoplasty) over the other in terms of patient health related quality of life and health     care resource utilization.      What is being studied?: We are studying (comparing) two surgical procedures for breast     reduction mammoplasty (vertical scar mammoplasty versus inferior pedicle reduction     mammoplasty).   "
176204|NCT00149357|"     The purpose of this study is to determine the risk of fetal loss in women with unprovoked     venous thromboembolism (VTE) who do not have identifiable inherited thrombophilia compared     with women who have the diagnosis of venous thromboembolism (VTE) excluded.   "
176205|NCT00149370|"     Despite the growing evidence showing that breast hypertrophy is associated with reduced     Health-Related Quality of Life (HRQL) and that reduction mammoplasty has a significant     positive impact on HRQL, there are unresolved issues that need to be addressed. These include     our ability to measure quantitatively the change that occurs after reduction and the ongoing     restriction or denials of third party payments based on body mass index (BMI). The primary     purpose of this study is to assess and measure the HRQL experienced by breast reduction     patients using four reliable and validated HRQL measures.      Fifty-two consecutive patients with the diagnosis of breast hypertrophy were invited to     participate in this prospective study. Participants completed the Health Utilities Index Mark     2 (HUI2) and Mark 3 (HUI3) and the Breast Reduction Assessment Value and Outcomes (BRAVO)     instruments (the Short Form 36, the Multidimensional Body-Self Rating Questionnaire     Appearance Assessment, and the Breast Related Symptom Questionnaire) at one week and one day     pre-surgery and one, six, and 12 months post-surgery.   "
176206|NCT00149383|"     The purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive     rosiglitazone in the treatment of uncomplicated P.falciparum malaria.   "
176207|NCT00149396|"     This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of     the study to determine and evaluate the safety and tolerability of repeated treatments with a     genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver.      Stage 2 is to evaluate the dose found in Stage 1 to be optimally tolerated. Stage 2 is to     assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination     with second-line chemotherapy.      Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the     study.   "
176208|NCT00149409|"     To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as     regards circulatory function.   "
176209|NCT00149422|"     The purpose of this study is to determine whether NT-proBNP guided treatment of chronic     congestive heart failure will reduce heart failure related morbidity and mortality compared     to therapy guided by standard clinical judgement.   "
176210|NCT00149435|"     To support follow-up for the Cardiovascular Health Study (CHS) of coronary heart disease and     stroke risk factors in adults 65 years or older.   "
176211|NCT00149448|"     The broad purpose of this project, proposed by investigators at the University of Alabama at     Birmingham and the State of Alabama Department of Public Health, is to use a behaviorally     focused education that has been proven effective to enhance the accuracy and efficiency of     the contact investigation process. The behaviorally focused intervention will focus on     enabling public health workers to understand and implement a recently published model of TB     transmission.   "
176245|NCT00149890|"     Systemic infection is still a major concern in young children with liver transplantation. The     approach of this study is to reduce the risk of systemic infections by avoiding     intraoperative steroids (another class of immunosuppressive drugs) given in combination with     basiliximab, cyclosporine and steroids in pediatric de novo liver transplant recipients. The     treatment is compared to the same treatment regimen including intraoperative steroids with     respect to rejection episodes.   "
176246|NCT00149903|"     Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared     to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the     incidence of biopsy proven acute rejection, graft loss, or death within six months of     treatment in de novo renal transplant patients.   "
176212|NCT00149461|"     The overall goal of this randomized, controlled study is to compare a model written treatment     plan with the usual care that is provided by a group of adult and pediatric pulmonologists     and allergists in their practice settings. The written treatment plan is a form that allows a     treatment regimen that is consistent with National Heart, Lung, and Blood Institute (NHLBI)     guidelines to be conveyed to patients. Barriers to the use of written plans will be     identified to better understand why some patients and physicians use written treatment plans     more frequently and effectively than others. An additional goal is to assess how patients     from different racial/ethnic backgrounds utilize treatments plans. Because asthma     disproportionately affects African American and Latino patients, another goal of this study     is to better understand if there are fundamental differences in the way patients from     racial/ethnic minority groups self-manage asthma in comparison to their white counterparts.     The study will also try to determine if differences exist in the way physicians care for     minority patients. If there are differences, it is important to determine if the disparities     can be overcome with the use of a written treatment plan form.   "
176213|NCT00149474|"     Evaluate the incremental effectiveness of peak flow monitoring ove symptom monitoring as a     management tool to enhance asthma control in adults >= 50 years with moderate-severe asthma.   "
176214|NCT00149487|"     The purpose of this study is to determine the effectiveness of a tailored problem solving     intervention in increasing adherence to asthma management behaviors in African American     adolescents with asthma.   "
176215|NCT00149500|"     We will evaluate the effect of an eighteen-month asthma coaching intervention for     parents/caregivers of children with asthma to reduce asthma morbidity. The primary objective     is to determine if asthma coaching will significantly reduce asthma morbidity as measured by     a reduction in the number of ED visits and hospitalizations for the children during the 18     months of active coaching and during the 18 months after the coaching stops.      We will provide half of the subjects (parents/caregivers) with access to assistance from an     asthma coach for 18 months (including 2 contacts with an asthma nurse during the first 6     months). The other half of the subjects will not have an asthma coach, but their children     will have their usual routine care with their primary care providers. The nurse and coach     will help the subjects learn more about caring for their children's asthma and improving     interactions with the primary care providers for their children.   "
176216|NCT00149513|"     King County Lung Injury Project: Survivor Outcome Study (KCLIP:SOS) is a randomized trial for     individuals who have survived prolonged mechanical ventilation (5 days or more). The     objective is to enroll individuals who are likely to have impaired health status resulting     from prolonged critical illness but whose long term prognosis is good. Such individuals are     most likely to benefit from the study intervention of case management targeted at post     intensive care complications.      KCLIP:SOS will test whether an outpatient intervention based on a nurse using a targeted case     management tool can reduce patient morbidity and improve quality of life in the 6 months     following hospital discharge. This intervention will be compared to usual post-hospital care.   "
176217|NCT00149526|"     To improve asthma outcomes by developing and evaluating strategies for enhancing the     clinic-patient partnership. To develop a model of shared decision-making for asthma     treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged     18-70 years with sub-optimally controlled persistent asthma.   "
176218|NCT00149539|"     Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to     buprenorphine in order to limit the abuse potential that is commonly associated with     buprenorphine. The purpose of this study is to determine the abuse potential of high doses of     buprenorphine/naloxone in opioid dependent individuals.   "
176219|NCT00149552|"     Zinc deficiency is prevalent in HIV infected individuals who abuse drugs. The purpose of this     study is to determine if zinc therapy will prevent immune failure in HIV infected individuals     who abuse drugs and have low plasma zinc levels.   "
176220|NCT00149565|"     * OBJECTIVES        1. To investigate whether adjuvant IFN-α therapy can delay or reduce the 2-5 years          recurrence rate in curatively resected HCC .        2. To examine whether adjuvant IFN-α therapy can prolong the disease-free survival in          curatively resected HCC.        3. To determine the safety and tolerance of adjuvant IFN-α therapy in postoperative HCC          with or without cirrhosis.        4. To investigate the change of activity of HBV and HCV in postoperative HCC patients with          adjuvant IFN-α therapy.        5. To correlate the changes of viral status with the clinical outcome in post-operative HCC          patients with adjuvant IFN-α therapy.   "
176221|NCT00149578|"     Induction chemotherapy will be administered every 2 weeks for 6 cycles (about 3 months).     Patients who have radiological evidence of progressive disease will be shifted to salvage     chemotherapy. Patients who have responsive or stable disease after induction chemotherapy     will receive concurrent chemoradiotherapy 3-4 weeks after the last dose of induction     chemotherapy. Surgical evaluation will be performed 4-6 weeks after the completion of     chemoradiotherapy. Patients who have resectable disease will undergo surgical resection.     Postoperative adjuvant chemotherapy with GOFL for 6 cycles will be given for those who have     curative resection. Patients who still have unresectable disease or non-curative resection     will receive systemic chemotherapy of GOFL till disease progression or unacceptable toxicity.   "
176222|NCT00149591|"     The VIAMI-trial investigates the effects of balloon angioplasty with stenting of the     infarct-vessel in the early phase after acute myocardial infarction. The study concerns     patients who have residual viable tissue in the infarct-area after being treated with     thrombolysis. It is postulated that only patients with remaining viable tissue are at     high-risk for recurrent infarction or anginal attacks and that stenting of the infarct-vessel     will reduce this risk considerably.   "
176223|NCT00149604|"     The purpose of this study is to determine whether estrogens specifically promote a reduction     in fat from abdominal regions during weight loss and/or prevent the accumulation of abdominal     fat during weight gain.   "
176224|NCT00149617|"     This study will assess the effectiveness of a combination of buspirone and motivational     interviewing therapy in the treatment of marijuana dependence.   "
176247|NCT00149916|"     Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate     sodium in regard to adverse events, serious adverse events and patient and graft survival.     After successful completion of the study CERL080A0107 study, patients could continue to     receive enteric-coated mycophenolate sodium.   "
176228|NCT00149669|"     A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic     Workplace in promoting naltrexone ingestion and abstinence in unemployed opiate-dependent     injection drug users. Participants will be offered an opioid detoxification and naltrexone     induction. Participants who complete the naltrexone induction will be randomly assigned to     one of two groups. Both groups will be invited to work in the Therapeutic Workplace and     prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to     work and earn salary. Work Plus Naltrexone Contingency participants will be required to     ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work     Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be     required to ingest it to work. This study will provide a rigorous evaluation of a novel     employment-based intervention, the Therapeutic Workplace, to promote naltrexone ingestion and     drug abstinence in a population of injection drug users who are at considerable risk of     spreading or contracting HIV infection. Hypotheses being tested in this study are: Naltrexone     ingestion will be maintained in the group exposed to the employment-based naltrexone     treatment significantly more than the group exposed to usual-care treatment package. Opiate     abstinence will be maintained in the group exposed to the employment-based naltrexone     treatment significantly more than the group exposed to usual-care treatment package.   "
176229|NCT00149682|"     The purpose of this study is to develop a web-based obesity risk assessment and counseling     tool and examine its feasibility and effectiveness in improving the rate and quality of     physician counseling about obesity, dietary change, and physical activity.   "
176230|NCT00149695|"     The primary aim of this randomized controlled trial is to evaluate the effects of replacing     habitual consumption of sugar-sweetened soft drinks with milk over 16 weeks.   "
176231|NCT00149708|"     Growth hormone (GH) deficiency (GHD) in adulthood has been associated with changes in body     composition (e.g. increased abdominal obesity, and reduced muscle mass), in organ functions     (e.g. reduced cardiac systolic function), in metabolic parameters linked to increased risk of     cardiovascular disease (e.g. increased serum total and LDL cholesterol, C reactive protein,     and plasma fibrinogen), and with reduced bone density. These observations have been used to     define the adult GHD syndrome and to advocate GH replacement therapy in GHD adults.     However, most of the studies have been performed in patients who have had hypothalamic or     pituitary diseases, and/or have undergone brain irradiation. Such patients are often     chronically sick, and commonly lack other pituitary hormones, whose replacement therapies may     not fully restore the physiological functions of the under-active glands. Reliable data on     the existence of the AGHD syndrome and its response to GH therapy can be only obtained by     studying patients that are otherwise healthy. However, isolated GH deficiency (IGHD) is a     rare disease. In addition, up to 50% of patients who have been diagnosed with IGHD in     childhood are no longer GH deficient as adults, making such study difficult to perform due to     the scarcity of patients population. We have identified a very large homogeneous population     of patients who have IGHD due to a homozygous mutation in the GHRH-receptor (GHRHR) gene that     resides in a rural area of Brazil. None of the adult dwarf patients has ever been treated     with hGH replacement. This population represents a unique model to study the effect of     isolated lifetime lack of GH. We propose studies of physiological and metabolic parameters in     subjects who are homozygous for this mutation and compare them with normal subjects residing     in the same community.      The primary goal of this proposal is to determine the consequences of life-long lack of GH on     body composition, muscle strength, cardiovascular status, cardiovascular risk factors,     thyroid status and bone density and metabolism, and to test which of these parameters are     reversed by a 6-month course of GH replacement therapy. In addition, we want to test the     hypothesis that heterozygosity for this GHRHR mutation causes a phenotype that may be     intermediate between the one present in homozygous normal subjects and in homozygous affected     GHD patients. This is relevant because inactivating mutations in the GHRHR are being     described with increasing frequency in populations of different genetic background,     suggesting that individuals with faulty single GHRHR alleles may be present in significant     numbers in the general population.   "
176232|NCT00149721|"     Hydrocephalus (secondary or idiopathic) is a condition characterized by dilatation of the     lateral and third ventricles, and often associated with increased intracranial pressure     (ICP). We hypothesize that either the ventricle dilatation or the increased ICP may cause     disturbances in the hypothalamic-pituitary axis, resulting in different degrees of     hypopituitarism. The goal of this study is to determine the prevalence of hypopituitarism in     adult patients with hydrocephalus.   "
176233|NCT00149734|"     This study will examine the effects of ondansetron on auditory nerve activity in people with     schizophrenia who are being treated with new antipsychotics.   "
176234|NCT00149747|"     This study will evaluate the effect of regular aerobic exercise on improving sleep in older     adults with moderate difficulty sleeping.   "
176235|NCT00149760|"     This study will examine the long-term effect of cognitive-affective behavior therapy on the     physical symptoms, functioning, and health care utilization of people with somatization     disorder.   "
176236|NCT00149773|"     This study will assess the effectiveness of cognitive therapy in reducing the incidence of     suicide ideation and behavior in older men in a primary care setting.   "
176237|NCT00149786|"     This study will compare the effectiveness of family-based therapy versus individual     psychotherapy for the treatment of adolescent anorexia nervosa.   "
176238|NCT00149799|"     This study's primary aim is to compare time to relapse and relapse rates in responders to     acute escitalopram who are then randomized to placebo versus continuation treatment with     escitalopram.   "
176239|NCT00149812|"     This study will assess the effectiveness of the Keeping Families Strong program (KFS) in     avoiding or delaying the onset of psychiatric disorders among children with depressed     mothers.   "
176240|NCT00149825|"     This study will examine the effectiveness of a combination of antidepressant medication and     sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.   "
176241|NCT00149838|"     This study will evaluate the safety and effectiveness of magnetic brain stimulation for the     treatment of major depression in depressed adults with moderate treatment resistance.   "
176242|NCT00149851|"     Gastroesophageal Reflux Disease (GERD) is a common disorder caused by the reflux of gastric     (stomach) acid into the esophagus. The exposure of the lining of the esophagus to the acid     will cause damage to the esophagus over time. The symptoms of GERD include heartburn and acid     regurgitation This study will determine if Tegaserod alone and in combination with omeprazole     is safe and relieves the symptoms of heartburn.   "
176243|NCT00149864|"     Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720     mg bid in combination with cyclosporine with/without steroids in regard to adverse events,     serious adverse events, and patient and graft survival. After successful completion of the     study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium     or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF     to enteric-coated mycophenolate sodium.   "
176252|NCT00149994|"     The purpose of this study is to determine whether cyclosporine A (in a micro emulsion     formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or     superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In     addition this study will assess the safety and tolerability of a cyclosporine A regimen based     on C-2h monitoring in comparison to the standard tacrolimus regimen.   "
176253|NCT00150007|"     The purpose of this study is to assess the impact that GI complaints have on patient reported     outcomes in renal transplant recipients and to determine if there is improvement in patient     reported outcomes when patients are converted to a EC-MPS-based immunosuppressive treatment.   "
176254|NCT00150020|"     The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance     renal transplant patients who experience gastrointestinal (GI) intolerance due to adverse     events associated with mycophenolate mofetil (MMF) and were converted to EC-MPS.   "
176255|NCT00150033|"     Background:      Thyroid diseases are frequent. They include both metabolic changes and gland enlargement     (goitre). Previous research and clinical suspicion indicate that the life quality of many     patients is reduced despite successful treatment. Research methods are, however, weak, and a     well-tested, disease specific quality of life questionnaire is especially needed. Several     treatment possibilities exist for each thyroid disease. For example, hypermetabolism can be     treated with either medication, radioactive iodine or by surgery. No comparative studies of     quality of life using the different treatment modalities exist.      Purpose:      To develop and evaluate a questionnaire to measure health-related quality of life in patients     suffering from thyroid diseases.      Methods:      To ensure that all relevant aspects are included, the questionnaire will be developed on the     basis of a systematic examination of the scientific literature and interviews with 13     physicians and 100 patients. The questionnaire will then be tested by 100 new patients. After     revision, the questionnaire will be answered by 1000 patients with a view to scientifically     investigate the measuring capacity of the questionnaire. This will be done using traditional     psychology methods (psychometry) as well as modern statistical methods (structural equations     for categorical data and item response models).      Relevance:      The above-mentioned questionnaire is necessary for clarifying whether these diseases reduce     quality of life and, in the long-term, whether a difference in quality of life exists using     the different treatment alternatives and whether treatment can be improved. It should also be     included in quality protection studies, in the evaluation of new treatment modalities and     possibly also in the treatment of the individual patient.   "
176256|NCT00150046|"     This study will test the safety and efficacy of everolimus on heart transplant recipients.      This study is not recruiting in the United States.   "
176257|NCT00150059|"     To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication     (treatment of patients > 3 months of age with mild to moderate atopic dermatitis)      This study is not enrolling patients in the United States.   "
176258|NCT00150072|"     Preliminary response data, observed by Casali (Cancer, 2004) with imatinib 800 mg/day in     patients affected by chordoma, need to be confirmed by a Phase II study, whose primary     endpoint will be the formal assessment of clinical and pathological response. Aim of the     study will be to explore treatment's activity, but also the potential impact of tumor     response, the feasibility and outcome of subsequent surgery and radiotherapy. In addition,     patterns of tumour response need to be investigated as well, given the peculiar patterns of     response shown with molecular-targeted therapy in solid tumors.   "
176259|NCT00150085|"     New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft     survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This     study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to     cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.   "
176260|NCT00150098|"     To determine the efficacy of an enhanced HIV risk reduction intervention delivered     concurrently with a vaccination schedule to reduce the number of unprotected vaginal and anal     sex acts among HIV-negative, high-risk non-injection drug-using (NIDU) women. To determine     the efficacy of an enhanced vaccine education intervention delivered at baseline to increase     vaccine knowledge and understanding of a potential HIV vaccine among HIV-negative, high-risk     NIDU women.   "
176261|NCT00150111|"     Aim:      In a phase II pilot study encompassing 20 patients with Graves’ disease to evaluate the     effect of rituximab:      1. Biochemically as assessed by markers of disease activity ( free T4, free T3, TSH,     TSH-receptor antibodies, anti-TPO)   "
176262|NCT00150124|"     Background: The use of radioactive iodine (131I) therapy as the definite cure of     hyperthyroidism is widespread. According to a survey on the management of Graves' disease,     thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs     (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced     'thyroid storm', which, however, is rarely encountered. Several studies have consistently     shown that patients who are treated with ATD prior to 131I therapy have an increased risk of     treatment failure. Mostly, patients with Graves' disease have been studied, while other     studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD     have 'radioprotective' properties, although this view is almost exclusively based on     retrospective data and is still under debate. Indeed, this dogma was recently challenged by     two randomized trials in Graves' disease, none of which showed such an adverse effect of     methimazole pretreatment. It cannot be excluded that the earlier results may have been under     influence of selection bias, a source of error almost unavoidable in retrospective studies.     Whether ATD is radioprotective also when used in the post 131I period has also been debated.     In the early period 131I therapy following a transient rise in the thyroid hormones is seen     which may give rise to discomfort in some patients. The continuous use of ATD during 131I     therapy, possibly in combination with levothyroxine (BRT: block-replacement therapy), leads     to more stable levels of the thyroid hormones. By resuming ATD following 131I therapy,     euthyroidism can usually be maintained until the destructive effect of 131I ensues.     Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting     that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the     evidence is based on retrospective studies and the ideal set-up should be reconsidered. To     underscore the importance of performing randomized trials we showed recently that resumption     of methimazole seven days after 131I therapy had no influence on the final outcome.      Aim:To clarify by a randomized trial whether BRT during radioiodine therapy of hyperthyroid     patients influences the final outcome of this therapy, in a comparison with a regime in which     methimazole as mono-therapy is discontinued 8 days before radioiodine.      Patients and Methods: Consecutive patients suffering from recurrent Graves' disease (n=50) or     a toxic nodular goiter (n=50) are included. All patients are rendered euthyroid by     methimazole (MMI) and randomized either to stop MMI eight days before 131I or to be set on     BRT. This latter medication continues until three months after 131I. Calculation of the 131I     activity (max. 600 MBq) includes an assessment of the 131I half-life and the thyroid volume.     Patients are followed for one year with close monitoring of the thyroid function.   "
176313|NCT00150800|"     This trial, evaluating the long-term safety and tolerability of brivaracetam will provide     subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive     treatment, the opportunity to receive open label brivaracetam treatment.   "
176263|NCT00150137|"     Background: The use of radioactive iodine (131I) therapy as the definite cure of     hyperthyroidism is widespread. According to a survey on the management of Graves’ disease,     thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs     (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced     ‘thyroid storm’, which, however, is rarely encountered. Several studies have consistently     shown that patients who are treated with ATD prior to 131I therapy have an increased risk of     treatment failure. Mostly, patients with Graves’ disease have been studied, while other     studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD     have ‘radioprotective’ properties, although this view is almost exclusively based on     retrospective data and is still under debate (13). Indeed, this dogma was recently challenged     by two randomized trials in Graves’ disease, none of which showed such an adverse effect of     methimazole pretreatment. It cannot be excluded that the earlier results may have been under     influence of selection bias, a source of error almost unavoidable in retrospective studies.     Whether ATD is radioprotective also when used in the post 131I period has also been debated.     In the early period 131I therapy following a transient rise in the thyroid hormones is seen     which may give rise to discomfort in some patients. The continuous use of ATD during 131I     therapy leads to more stable levels of the thyroid hormones. By resuming ATD following 131I     therapy, euthyroidism can usually be maintained until the destructive effect of 131I ensues.     Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting     that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the     evidence is based on retrospective studies and the ideal set-up should be reconsidered. To     underscore the importance of performing randomized trials we showed recently that resumption     of methimazole seven days after 131I therapy had no influence on the final outcome.      Aim: To clarify by a randomized trial whether continuous use of methimazole during     radioiodine therapy influences the final outcome of this therapy, in a comparison with a     regime in which methimazole as mono-therapy is discontinued 8 days before radioiodine.      Patients and Methods: 80 consecutive patients suffering from recurrent Graves’ disease or a     toxic nodular goiter are included. All patients are rendered euthyroid by methimazole (MMI)     and randomized either to stop MMI eight days before 131I or to continue MMI until four weeks     after 131I. Calculation of the 131I activity (max. 600 MBq) includes an assessment of the     131I half-life and the thyroid volume. Patients are followed for one year with close     monitoring of the thyroid function.   "
176264|NCT00150150|"     Nodular goitre is common in the general population and less than 5% of the patients who     undergo surgery for solitary thyroid nodules have cancer, in absence of clinical suspicion.     Nodules left untreated seem to have a slight growth potential in borderline iodine-deficient     areas. Interstitial laser photo-coagulation (ILP) is a procedure for local hyperthermia and     photocoagulation, allowing minimally invasive treatment of benign tumors, including thyroid     nodules. The aim of these studies are to evaluate if ILP will be useful in reducing the     volume of the benign thyroid nodule and thyroid function will be unaffected in euthyroid     patients, and normalized in pretoxic- and toxic thyroid nodules. The investigations are     listed below:        1. Randomized study of interstitial laser photocoagulation for benign solitary cold thyroid          nodules – one versus two or three treatments        2. Randomized study of interstitial laser photocoagulation for benign solitary autonomous          thyroid nodules – 131I versus laser ablation        3. Interstitial laser photocoagulation for benign thyroid cystadenomas. – a feasibility          study.   "
176265|NCT00150163|"     Objective:        -  To define a reference-population of healthy young men (20-29 years old).        -  To establish reference-intervals for:             1. Total, bioavailable and free serum androgens (testosterone, dihydrotestosterone,               androstenedione) and serum estrogens (estradiol, estrone).             2. Total and free IGF-1.        -  To study the influence of physical activity, alcohol intake, tobacco and abuse of          anabolic steroids on serum levels of androgens.        -  To identify the androgens (or estrogens) that primarily reflect the following          parameters:             1. Muscle mass, muscle strength, muscle power, oxygen uptake, and hematocrit.             2. Bone mineral density and bone metabolism.             3. Total and visceral fat mass.             4. Lipid- and glucose metabolism and glucocorticoid metabolism.             5. Sexual function and quality of life.        -  To study the modifying effect of birth weight, the AR gene CAG-repeat polymorphism, and          the level of IGF-1 on associations between serum androgens and the measures above:      Ethics, design and schedule:      The local ethic review board approved a population-based, cross-sectional study planned for     the inclusion of 800 Caucasian men, 20 to 29 year old, living in the County of Funen. The     only exclusion criteria were opioid drug addiction, cancer, and severe chronic disease. A     basic questionnaire was mailed to 3000 men, randomly drawn from the Danish Central Personal     Registry. Adequately answered questionnaires were returned from 2,199 men, who subsequently     received an invitation to participate. Informed consent was obtained from 783 men. The     examinations started in March 2002 and terminated in May 2003. Within subject variation was     determined for all study parameters in 20 men. The men included matched the men answering the     questionnaire on all questionnaire items and demographics. All analyses have been performed,     except for the additional serum sex hormone assays, IGF-1 assays and AR gene analyses.      A sequential rule-out from the reference population was performed on the following criteria:        1. testicular pathology: bilateral cryptorchidism, varicocele, testes volumina < 10 ml          (each), history of spermatic cord torsion.        2. severe chronic disease.        3. regular medication or abuse of anabolic steroids.        4. body mass index < 19 kg/m2.        5. safety serum parameters: luteinizing hormone (LH) <1.0 U/L or >8.4 U/l,          alanine-amino-transferase (ALAT) >70 U/l and thyrotropin (TSH) >6.0 mU/l.   "
176266|NCT00150176|"     Schizophrenia is a brain disease. The condition may be associated with acute psychotic     episodes and long-term disability despite remission from the acute symptoms. Current     management of schizophrenia focuses on the treatment of acute symptoms as well as long-term     treatment aimed at preventing relapse after patients have experienced an improvement in acute     symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse     within 1-2 years after an acute episode of schizophrenia. Patients who remain on     antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation     when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in     the brain, primarily dopamine and serotonin, which enables brain cells to communicate with     each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The     purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing     relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been     treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine     the safety and tolerability of asenapine for up to 1-year of treatment.   "
176267|NCT00150189|"     The study explores the potential benefits of a sugar water solution for decreasing pain in     infants during routine immunizations.   "
176268|NCT00150202|"     This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients     with wet-type AMD, in order to establish that there is no large difference in the efficacy     and the safety of the drug between Western and Japanese patients.   "
176269|NCT00150215|"     The purposes of this study are:        -  To determine the safety, tolerability and pharmacokinetics of single doses of          PF-00184562; and        -  To explore the exposure-response relationship of neuropsychometric and tolerability          measures of PF-00184562 compared to olanzapine.   "
176270|NCT00150228|"     The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing     strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up     of smoking status to one year from randomization was performed in a non-treatment extension     Protocol A3051019   "
176271|NCT00150241|"     The purpose of the study is to measure the safety and efficacy of three doses of varenicline     for smoking cessation.   "
176314|NCT00150813|"     An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse     events reporting.   "
176272|NCT00150254|"     The purpose of the study is to measure the safety and efficacy of four dosing strategies of     CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up     of smoking status to one year from randomization was performed in a non-treatment extension     Protocol A3051018   "
176273|NCT00150267|"     To estimate the frequency of patients with ocular/periorbital adverse events. To identify any     possible long-term adverse consequences of increased iris pigmentation and to follow serious     adverse events throughout the study period.   "
176274|NCT00150280|"     To validate the analgesic efficacy and safety of celecoxib compared with ibuprofen SR in the     management of acute pain post orthopedic or gynecological surgery   "
176275|NCT00150293|"     To determine long-term safety and efficacy of pregabalin in patients with partial seizures.   "
176276|NCT00150306|"     To evaluate the safety and efficacy of sertraline compared to placebo in children and     adolescents (6 to 17 years of age) who are outpatients with Posttraumatic Stress Disorder.   "
176277|NCT00150319|"     This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous     voriconazole and SBECD in patients with moderate renal insufficiency   "
176278|NCT00150332|"     Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections in     Japan   "
176279|NCT00150345|"     A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the     number of white blood cells, especially of the so-called neutrophil granulocytes, which are     very important for the defense against infections. Hence their decrease (called     neutropenia) leads to a predisposition to infections.      Since infections during neutropenia can be very dangerous, the patients are treated with     antibiotics from the very first signs of such an infection (usually fever). If the     antibiotics (drugs against bacteria) do not lead to a normalization of the body temperature     within four days, a drug against fungi is added.      In the IDEA study, one half of the patients receive the antifungal drug voriconazole (as     usual) only in case the antibiotics alone do not lead to a normalization of the body     temperature (current standard of care). The other half of the patients receive voriconazole     immediately after onset of fever (concomitantly with the antibiotics).      The research question is, whether in the early-treatment group fewer manifest fungal     infections will be observed than in the late-treatment group.   "
176280|NCT00150358|"     To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and     antihypertensive therapy.   "
176281|NCT00150371|"     The objective of this study is to assess the effectiveness of an atorvastatin treatment     regimen involving starting doses between 10 and 80 mg, followed by a single-step titration     (except for subjects started at 80mg), if required   "
176282|NCT00150384|"     The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African     American population   "
176283|NCT00150397|"     This is an initial proof of concept, phase to study to assess the safety and efficacy     tofimilast for the chronic maintenance treatment of adults with persistent asthma   "
176284|NCT00150410|"     -  Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an          investigational drug, controls your diabetes at least as much as a triple combination          therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration          (FDA) approved drug.        -  Whether a combination of two therapies - metformin plus Exubera controls your diabetes          at least as much as a as a triple combination therapy of metformin and a sulfonylurea          plus Avandia.   "
176285|NCT00150423|"     To evaluate the safety and efficacy of pregabalin in patients with painful diabetic     peripheral neuropathy.   "
176286|NCT00150436|"     To evaluate long-term safety and efficacy of pregabalin in patients with postherpetic     neuralgia.   "
176287|NCT00150449|"     Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.   "
176288|NCT00150462|"     The purpose of this study is to test the safety and tolerability of carfilzomib at different     dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma,     Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor,     an enzyme responsible for degrading a wide variety of cellular proteins.   "
176289|NCT00150475|"     Highly communicable and virulent diseases, the ongoing threat of emerging infectious     diseases, and the prospect of bio-terrorism have become part of the new reality for health     care workers. SARS transmission has occurred despite the use of droplet, contact, and     airborne precautions. Potential explanations for some of the episodes of     “through-precautions” transmission include the possibility of contamination during removal of     protective clothing.      The recommended protective systems (PPS) for aerosol generating procedures set out by the US     Center for Disease Control and Prevention (CDC) and the Ontario Ministry of Health and Long     Term Care (MOHLTC) differ.      The failure of a PPS may be associated with significant consequences in terms of the     morbidity and mortality of front-line health care workers. The purpose of this study is to     determine if a difference exists between the rate of self-contamination due to deficiencies     in contact precautions for individuals wearing either the CDC or MOHLTC recommended PPS.      Study participants will don one of the two recommended PPS, be “contaminated” with an     indicator that becomes visible under ultraviolet light, and then assessed for contamination     of clothing layers and skin after removal of the PPS. They will then repeat the procedure     using the other PPS.   "
176290|NCT00150488|"     This protocol describes a multi-centre, community based open label study designed to assess     the efficacy and safety of intravesical sodium chrondroitin sulfate (Uracyst®) in the     treatment of patients with a clinical diagnosis of interstitial cystitis (IC).      The safety of the study product will be evaluated through the incidence of adverse events and     from results of physical examinations and laboratory tests.   "
176291|NCT00150514|"     The objective of the study is to document the objective immunological effects of SLIT on the     nasal mucosa. Better understanding of these immunological pathways, in which this widely     practised clinical therapy is likely to work, can only benefit the overall outcome of this,     more patient friendly, therapy and it will demonstrate the effects of SLIT on the allergic     reaction, with objective parameters, in the nasal tissues showing it to be a true etiological     treatment of allergy.   "
176292|NCT00150527|"     Citalopram, a selective serotonin reuptake inhibitor (SSRI), is used as a neuroendocrine     probe in human subjects to assess serotonin (5-hydroxytryptamine; 5-HT) function as reflected     in prolactin and plasma cortisol release. Citalopram is a racemic mixture of equal parts of     the S(+) and R(-) enantiomers. The S(+) form (escitalopram) has been identified as being     the active isomer and inhibitor of serotonin reuptake and consequently antidepressant     activity is associated almost exclusively with the S-enantiomer. Escitalopram has been shown     to be approximately twice as potent as citalopram at the primary, high-affinity binding site     on the human serotonin transporter. Interestingly, investigations have suggested an     antagonistic interaction of the R- and S-enantiomer at an allosteric binding site on the     serotonin transporter. This antagonism has been shown in animal studies where the addition of     R-citalopram to escitalopram treatments significantly counteracts the antidepressant and     anti-anxiolytic effects of escitalopram. From these clinical and experimental data, the     researchers can anticipate that escitalopram would increase cortisol and prolactin in the     neuroendocrine challenge paradigm more effectively than citalopram.   "
176293|NCT00150540|"     The purpose of this study is to assess the safety of lanthanum carbonate in patients     undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to     continue treatment.   "
176294|NCT00150553|"     The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar     manic symptoms, when given once daily in the evening vs. twice daily.   "
176295|NCT00150566|"     The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the     pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal     disease.   "
176296|NCT00150579|"     The purpose of this study is to assess the safety and effectiveness of SPD465 compared to     placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also     look at how SPD465 affects sleep and how the participants perceive their quality of life.   "
176297|NCT00150592|"     The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks     of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.   "
176298|NCT00150605|"     The purpose of this study is to evaluate the safety of SPD417 when given with other     psychotropic medications to treat bipolar I disorder.   "
176299|NCT00150618|"     The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the     treatment of children and adolescents aged 6-17 with ADHD.   "
176300|NCT00150631|"     The present study examine healthy, normotensive subjects 18 to 36 years of age whose both     parents have essential hypertension. The subjects receive treatment with either the     AT1-antagonist candesartan cilexetil, 16 mg daily or placebo for one year. Then, treatment is     withdrawn and the subjects is followed for 10 years to determine if the treatment has been     able to either prevent or delay the development of hypertension. The primary objective is to     determine whether pharmacological treatment with an angiotensin receptor blocker is able to     restrain or delay the progression to hypertension. Secondary objectives are to investigate     whether any long-term effect on blood pressure is related to the effect of treatment on renal     haemodynamic function, or on the left ventricle mass.   "
176301|NCT00150644|"     The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of     asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the     morphology of the endometrium and uterine fibroids.   "
176302|NCT00150657|"     -  this study is being done to find out if the combination of carboplatin and gemcitabine          will be more effective in the the treatment of advanced lung cancer if bevacizumab, an          agent that blocks tumor blood vessel formation, is added        -  the study will measure the time to progression of patients treated with the combination;          we hope to show that the addition of bevacizumab improves the time to progression          (increases the amount of time before the disease begins to worsen)        -  all patients receive all three drugs; there is no placebo   "
176303|NCT00150670|"     This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy     compared with the monotherapy by TS-1 alone.   "
176304|NCT00150683|"     The purpose of this study is to find out if standing and/or standing with vibration works for     the treatment of osteoporosis for people with a spinal cord injury.   "
176305|NCT00150696|"     The purpose of this study is to find out if Risedronate works to prevent osteoporosis after     spinal cord injury.   "
176306|NCT00150709|"     The open-label study to allow pediatric patients who have participated in prior Levetiracetam     (Keppra®) studies to continue their treatment with adequate monitoring and standardized     follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the     completion of the development program for pediatrics.   "
176307|NCT00150722|"     It is well known that lowering low-density lipoprotein (LDL) (bad cholesterol) is beneficial     for decreasing heart attacks and death. More recently, focus has been on trying to raise HDL     (good) cholesterol. The purpose of the present study is to determine if the addition of a     sustained release preparation of niacin (Niaspan - a medicine to raise HDL cholesterol) to     LDL lowering with a statin type medication results in improved vascular health. The study of     the well being of one's vessel wall (endothelial function) will serve as a marker of     treatment effect in the study.      Hypotheses: Extended-release (ER) niacin will improve endothelial function measured as     brachial flow-mediated dilation (FMD - 10 end-point) and as pulse volume amplitude by pulse     arterial tonometry (PAT) (20 end-point) in subjects with established atherosclerosis whose     LDL cholesterol is optimally treated with statin therapy.   "
176308|NCT00150735|"     A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used     as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from     epilepsy, and experiencing partial or generalized tonic-clonic seizures.   "
176309|NCT00150748|"     An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in     children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.   "
176310|NCT00150761|"     Phase IV, human pharmacology, exploratory, randomized, 3-way (3 treatment periods)     cross-over, double blind, double dummy, placebo controlled study to compare levocetirizine     and cetirizine by means of IR thermography.   "
176315|NCT00150826|"     INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin     converting enzyme) inhibition (quinapril) in improving coronary microvascular function.      PATIENT POPULATION Women who meet the National Heart, Lung and Blood Institute-sponsored WISE     (Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary flow     reserve limitations and evidence for myocardial ischemia in the absence of significant     coronary artery stenosis.      STUDY DESIGN A prospective, randomized, placebo-controlled, comparative trial. TREATMENT     Quinapril 80 mg/d versus placebo for four months. PRIMARY EFFICACY PARAMETER(S) Coronary flow     reserve (CFR) at Week 16 adjusted for baseline CFR, treatment group assignment, site-specific     variables, and site by treatment effects.      SECONDARY EFFICACY PARAMETERS Week 16 change in chest discomfort as measured by the Seattle     Angina Questionnaire adjusting for baseline values, site, and site by treatment effects.      SAFETY PARAMETERS Hematology, blood chemistries, blood pressure and pulse, and frequency and     occurrence of adverse events.      STATISTICAL RATIONALE AND ANALYSIS A statistical rationale for the number of patients in the     study has been provided. Interim analyses are planned after 15 patients have been enrolled in     each group.      ANTICIPATED TOTAL NUMBER OF PATIENTS 78 (39 per group). ANTICIPATED NUMBER OF PATIENTS AT     EACH SITE Approximately 26   "
176316|NCT00150839|"     The proposed study is a randomized, placebo-controlled, double-blind trial to evaluate the     safety and efficacy of antidepressant combination for the treatment of depression.      Depressive disorder is one of the most common human diseases with a high burden for every     patient, her/his family, health care system and society as a whole. Actual treatment concepts     of depressive disorders include pharmacologic, biologic (e.g. electroconvulsive therapy,     light therapy) and psychologic therapy. Even though effective therapeutic options are at     hand, therapy needs time. It is often not possible to reach full remission of the disease and     10-25% of patients suffering from depression are regarded as treatment-resistant. In     treatment resistant depression, the use of a combination of antidepressive drugs is     considered safe and effective. However, at present no data exist concerning the use of drug     combination as primary therapeutic option. The aim of the study is to examine the hypothesis,     that significantly more patients achieve full remission of depressive symptoms when treated     with the combination of two antidepressants and as a secondary hypothesis, that patients     receiving a drug combination will achieve remission faster than patients treated with     monotherapy. To test these hypotheses, a two group parallel design is used comparing the     efficacy and safety of mirtazapine in combination with venlafaxine or placebo.   "
176317|NCT00150852|"     The aim of this study is to determine whether vancomycin with cefazoline is superior to     vancomycin with placebo in preventing gastrostomy-related wound infection in carriers of     methicillin-resistant staphylococcus aureus (MRSA).   "
176318|NCT00150865|"     Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group     randomized, includes 30 patients. block performed preoperatively Surgery under general     anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine     consumption via PCA device. Follow-up : 24h.      Expectation : sizeable reduction of pain with block, of duration.   "
176319|NCT00150878|"     The primary goal of the study is to show that the treatment-related mortality of allogeneic     hematopoietic stem cell transplantation an be significantly reduced by using a combination of     8 Gy total-body-irradiation and fludarabine in comparison to the conventional combination of     12 Gy TBI and 120 mg/kg Cyclophosphamide.   "
176320|NCT00150891|"     Chronic transplant rejection remains the main cause of late kidney graft loss. We showed     previously that patients with pretransplant CD4 helper defects and low in-vitro IL-10     responses demonstrated an extremely low risk of acute rejection and a significantly better 1-     and 3-year graft function whereas pretransplant Th1 responses were not predictive (Weimer R     et al. 1996 and 1998). In liver transplant recipients, we found CD4 helper function and     in-vitro IL-10 responses significantly decreased compared to CsA-treated patients (Zipperle     et al. 1997). If the same effect will be demonstrated in renal transplant recipients,     Tacrolimus (Tacr) treatment might result in enhanced graft survival compared to CsA, when CD4     helper function and in-vitro IL-10 responses of the individual patient are elevated. Other     studies of our group suggest a beneficial role of enhanced T-suppressor activity and of an     IL-6 independent B cell/monocyte defect in the maintenance of long-term stable graft     function, whereas enhanced monokine secretion (TNF-a, GM-CSF, IL-6) was found in chronic     rejection (Weimer et al. 1990, 1992, 1994, 1998).      In the current randomized prospective study we will analyze the impact of CsA versus Tacr and     of MMF versus azathioprine on Th1, Th2 and monokine responses and their predictive value     regarding occurrence of acute and chronic rejection. With a proposed follow-up of 5 years     this study might enable a patient-tailored immunosuppressive therapy resulting in prolonged     graft survival.   "
176321|NCT00150904|"     Hepatitis C and HIV infect worldwide millions of people leading to a high rate of coinfected     patient with eventually liver cirrhosis and endstage liver disease. With the currently best     available therapy (peginterferon and ribavirin) only less than 50% of patients with HCV     genotype 1 will respond. Unknown is what factors determine this difference in treatment     outcome. Probably virologic and immunologic factors play a major role. By investigating blood     samples of HCV / HIV coinfected patients and HCV mono-infected patients we would like to     examine both virologic and immunologic factors possibly responsible for this difference.   "
176322|NCT00150917|"     One in 10 Canadian women will be diagnosed with breast cancer (BC) and approximately 5% of     all BC is believed to be hereditary. Women with a family history experience high levels of     perceived risk for developing BC. Elevated risk perceptions for BC have been associated with     psychological distress, which, in turn, can interfere with screening adherence. In our     completed CBCRI-funded study, we developed and standardized a group intervention designed to     address the psychological issues associated with having a family history of BC. Results     demonstrated that the intervention led to significant improvement in levels of anxiety and     depression, improved BC risk factors/genetics knowledge and was associated with optimal     screening behavior. The proposed study will rigorously test the group intervention in     comparison to standard risk counselling in a sample of 150 women recruited from Familial BC     clinics in Toronto. The interventions will be examined for their impact on a) psychological     functioning, b) BC risk/genetic knowledge and c) screening behaviors.   "
176323|NCT00150930|"     UVB phototherapy is a commonly used treatment for patients with psoriasis. Generally it is     performed in the outpatient department of the hospital. The UVB irradiation itself will     normally take only a few minutes, but to receive the irradiation patients have to travel to     the outpatient department during working hours 2 or 3 times a week. In general it is a     relatively time-consuming treatment.      Objective of this study is to assess whether UVB treatment administered in the home is as     equally effective as the standard outpatient UVB phototherapy. Quality of life and     cost-effectiveness are also studied.   "
176324|NCT00150943|"     Background:      Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal     function and is one of the most important causes of renal failure in the elderly. Current     treatment includes restoration of the renal arterial lumen by endovascular stent placement.     However, this treatment only affects damage caused by ARAS due to the stenosis and ensuing     post-stenotic ischemia. ARAS patients have severe general vascular disease. Atherosclerosis     and hypertension can also damage the kidney parenchyma causing renal failure. Medical     treatment focuses on the latter. Lipidlowering drugs (statins) could reduce renal failure     progression and could reduce the overall high cardiovascular risk. The additional effect on     preserving renal function of stent placement as compared to medical therapy alone is unknown.     Therefore, the STAR-study aims to compare the effects of renal artery stent placement     together with medication vs. medication alone on renal function in ARAS patients.      Method:      Patients with an ARAS of ≥50% and renal failure (creatinine (Cr) clearance <80 mL/min/1.73     m2) are randomly assigned to stent placement with medication or to medication alone.     Medication consists of statins, anti-hypertensive drugs and antiplatelet therapy. Patients     are followed for 2 yrs with extended follow-up to 5 yrs. The primary outcome of this study is     a reduction in Cr clearance >20% compared to baseline. This trial will include 140 patients.   "
176325|NCT00150956|"     This study was designed to discover mechanisms responsible for the decrease in (high) blood     pressure after starting daily hemodialysis, as has been observed by various investigators. We     hypothesized that better control of body water and sodium content and a decline in the     autonomic (sympathetic) nervous system activity, increased in chronic renal failure patients,     would contribute to improved blood pressure regulation.      Moreover, we studied the effects of daily hemodialysis on mental functions, like information     processing and memory, in relation to the previously reported improvement in quality of life,     and the effects on nutrition. We hypothesized that all would improve.   "
176326|NCT00150969|"     The purpose of this study is to determine whether supplementation with 5 mg vitamin K daily     over a 2-year period will prevent bone loss in post-menopausal women with osteopenia.   "
176327|NCT00150982|"     To determine the mechanism of action of alefacept in patients with psoriasis.   "
176328|NCT00150995|"     Purpose: The aim of this clinical trail is to evaluate Tetrathiomolybdate (TM) in the     treatment of hormone refractory prostate cancer.   "
176329|NCT00151008|"     To determine if bexarotene gel with NBUVB phototherapy is more effective than placebo plus     NBUVB for moderate to severe plaque-type psoriasis.   "
176330|NCT00151021|"     The primary purpose of this study is to test an Internet based program along with an enhanced     pedometer to promote walking in people with diabetes. The major research question to be     answered is if counseling and feedback that emphasizes a 10-minute minimum duration for     physical activity bouts result in a different pattern of walking behavior compared to     counseling and feedback focusing only on total daily accumulated steps.   "
176331|NCT00151034|"     Purpose: The purpose of this study is to evaluate the efficacy and safety of treatment with     trastuzumab (Herceptin) along with the three other chemotherapy drugs, paclitaxel,     carboplatin and gemcitabine, in patients who have advanced urothelial cancer. This clinical     trial will also collect information (alternative therapy, response rates, overall survival)     from enrolled patients with HER2 negative tumors who are ineligible to receive study     treatment.   "
176332|NCT00151047|"     Purpose: The purpose of this clinical trial is to look at the chemotherapy combination of     docetaxel and capecitabine in the treatment of newly diagnosed or locally advanced prostate     cancer, and to determine if this treatment is an acceptable, effective and a safe treatment     option. In addition, this clinical trial will evaluate how this treatment affects chemicals     (enzymes), and other cancer related genetic changes in the tumor. Optional: This clinical     trial will conduct extra imaging studies for research purposes including combined endorectal     prostate magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRSI) and     diffusion weighted imaging (DWI) to evaluate prostate cancer and response to study treatment.   "
176333|NCT00151060|"     Hormonal therapy is the standard treatment for prostate cancer which has spread to other     areas of the body. Despite the high initial response rates to hormonal therapy, the vast     majority of men will develop cancer which is no longer responsive to hormone deprivation. The     average time for hormonal therapy to be effective is about 18 months. Chemotherapy     combinations which can treat the disease when it no longer responds to hormonal therapy have     been developed, but these treatments are not curative. One of these combinations is     estramustine, etoposide and paclitaxel. In men with far advanced disease, 60% will have a     decrease in their PSA (Prostate Specific Antigen) or shrinkage of tumors after treatment with     this chemotherapy. Despite this, these men have all developed further disease progression     requiring additional treatment. One possible way to make chemotherapy more effective is to     give it when the number of tumor cells is smallest, and the number of cells to be killed is     at a low level. One situation in which this is true is when a man has responded to hormonal     therapy any tumors are at their smallest size. This study will test whether the addition of     chemotherapy at that time will prolong the time until the cancer becomes unresponsive to     hormonal therapy.   "
176334|NCT00151073|"     Purpose: The aim of this clinical trail is to evaluate the effectiveness of Zoledronate     (Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients     with hormone-refractory prostate cancer.   "
176335|NCT00151086|"     Purpose: This clinical trail will combine the chemotherapy drugs, Estramustine and     Vinorelbine (Navelbine), on an intermittent therapy strategy based on PSA response in the     treatment of hormone refractory prostate cancer. The investigators will determine the     tolerable dose of (oral) vinorelbine in combination with (oral) estramustine, and evaluate     the efficacy of this treatment for patients with hormone-refractory prostate cancer.   "
176337|NCT00151112|"     The purpose of this study is to investigate the influence of difference positioning on     extension and efficacy of brachial plexus anesthesia at 20 minutes by using the axillary     plexus block with supine positioning and a lateral positioning onto the non-anaesthetized     side, combined with 20° Trendelenburg positioning.   "
176338|NCT00151125|"     This study is testing the use of rhIL-11 (recombinant interleukin 11, Neumega) in individuals     with Von Willebrand disease. The purpose is to evaluate:        1. if rhIL-11 corrects VWF (Von Willebrand Factor) levels to normal        2. if rhIL-11 and DDAVP together will boost VWF levels even higher        3. the onset, peak, and duration of rhIL-11 effect        4. if rhIL-11 is safe in individuals with Von Willebrand Disease   "
176339|NCT00151138|"     Randomized trial of two antihypertensive drugs of known efficacy to investigate whether one     has more favorable effects on brain blood flow and cognitive function.   "
176340|NCT00151151|"     This is a randomized clinical trial assessing the efficacy of two types of counseling     (Computer-Assisted Motivational Intervention [CAMI] versus Didactic Educational Counseling     [DEC]) to see which can better reduce female adolescents' risk taking behaviors that put them     at risk for unintended pregnancy and sexually transmitted diseases (STDs). The intervention     phase consists of three 30-minute counseling sessions over the first 6 months followed by a     visit every three months during the 12 month follow up phase. We, the researchers,     hypothesize that the CAMI will decrease the proportion of subjects who engage in any     intercourse that is poorly protected against pregnancy and against STDs.   "
176341|NCT00151164|"     The investigators hypothesize that injecting donor bone marrow cells into the recipient     thymus gland at the time of heart transplantation in children will prove to be feasible and     safe. They further hypothesize that recipients receiving donor bone marrow will experience     less acute rejection events with reduced long-term requirements for immunosuppressive     medications when compared to controls who do not receive marrow but who are managed under an     identical immunosuppressive protocol.   "
176342|NCT00151177|"     More than half of all stroke patients have sleep apneas in the acute phase after stroke.     Sleep apneas may be associated with higher degrees of disability three months after stroke     due to numerous factors associated with sleep apneas such as persistent hypertension, cardiac     arrhythmias, and clotting disorders.      Non-invasive CPAP (continuous positive airway pressure)-therapy may reverse a number of these     effects very shortly after initiation. The aim of the study is to test the feasibility of     early non-invasive CPAP treatment starting in the first night after stroke onset, and to test     its efficacy in a randomized clinical trial.      50 patients with acute ischemic stroke will be enrolled and randomly assigned to standard     care PLUS CPAP treatment or standard care only. All patients randomized to the intervention     group will receive CPAP therapy for the first three nights after stroke. In the fourth night,     a cardiorespiratory polygraphy will be performed in patients and controls. Patients assigned     to the intervention group with a respiratory distress index > 10/h will be treated further     on. On admission, day 4, and day 10 after stroke, diffusion weighted MRI imaging will be     performed to determine the size of the infarction. The NIHSS score will be used to assess     clinical short-term outcome on day 4 and day 10. After three months, the outcome will be     determined using the modified Rankin scale.      As CPAP therapy may be more laborious for the provider, the additional work-load will be     documented using pre-specified scales.      Primary hypothesis of the study is, that CPAP therapy is feasible in acute stroke patients     and that the additional work load will not outweigh the benefits.      Secondary hypothesis is that patients assigned to the treatment group have smaller     infarctions on MRI and less neurological deficits at 3 months after stroke.      Patients entering the study will be investigated by transcranial Doppler ultrasound in case     they have sufficient temporal bone windows for insonation and no stenosis or occlusions of     major brain supplying arteries by the time of investigation that disturb the intracerebral     blood flow.      All intracranial arteries will be assessed before treatment, after treatment and on day 8     after the insult.      Screen shots will be taken and will be analysed by dynamic vascular ultrasound (DVA), a new     software algorithm developed by NHSi, to investigate microcirculatory information from the     flow spectra of the major intracranial arteries.      The data from this post-hoc analysis are compared with the data of the polysomnography and     with treatment.      Primary hypothesis in this substudy is that DVA reliably identifies patients with sleep apnea     on days one and four after stroke. Secondary hypothesis is that DVA can distinguish between     treated patients and controls.   "
176343|NCT00151190|"     The study is intended to determine the effectiveness and efficiency of a community diabetes     education program administered by a community health worker in a low-cost community clinic.     We expect an improvement in overall glycemic control in the experimental group of at least     20%. We also expect to document improvement in diabetes self-management skills, quality of     life and an increase in achievement of ADA standards of care4 in the experimental group.   "
176344|NCT00151203|"     PRIMARY STUDY OBJECTIVES        -  To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide          (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with          newly diagnosed multiple myeloma (MM).        -  To evaluate the safety of the combination of clarithromycin, lenalidomide, and          dexamethasone as an induction therapy for patients with newly diagnosed MM.      SECONDARY STUDY OBJECTIVES        -  To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone          and lenalidomide.        -  To examine the angiogenesis profile in untreated patients and in patients receiving          induction therapy.   "
176345|NCT00151216|"     The aim of this study is to treat the signs and symptoms of late infantile neuronal ceroid     lipofuscinosis (LINCL), a fatal inherited disease in the brain. This will be accomplished by     using delivery of a gene (method called gene transfer) to administer to the brain an     experimental drug called AAV2CUhCLN2, a gene transfer vector.   "
176346|NCT00151229|"     The aim of this study is to compare the incidence of cardiovascular events between two target     systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with     valsartan in elderly isolated systolic hypertensive patients in Japan.   "
176347|NCT00151242|"     This trial is a study on all-trans retinoic acid in combination with induction and     consolidation therapy as well as pegfilgrastim after consolidation therapy in younger     patients with newly diagnosed acute myeloid leukemia (AML).   "
176348|NCT00151255|"     This is a study looking at all-trans retinoic acid in combination with standard induction and     consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML).   "
176349|NCT00151268|"     In a separate protocol the Department of Genetic Medicine is proposing to carry out a study     using gene transfer to treat the central nervous system (CNS) manifestations of late     infantile neuronal ceroid lipofuscinosis (LINCL), a fatal, rare, recessive disorder of the     (CNS) in children. In the context that there is little known about the genotype - phenotype     correlations of LINCL, and that our referral far exceed the number (n=11) of children that     will be entered into the gene transfer protocol, we are proposing to capitalize on this     unique opportunity to evaluate this disorder in this separate study. In this context, the aim     of this protocol is to study the genotype - phenotype correlations of the CNS manifestations     of late infantile neuronal ceroid lipofuscinosis. This will be accomplished by comparing the     genotype to a neurologic assessment, and LINCL clinical rating scale; magnetic resonance     imaging (MRI) and magnetic resonance spectroscopic (MRS) assessments of the CNS; and routine     clinical evaluations.   "
176350|NCT00151281|"     Primary Objective:      Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide,     and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle     cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be     assessed.      Secondary Objectives:        1. Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell          lymphoma.        2. Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma          during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated          with clinical response to RT-PEPC therapy.        3. Assess the quality of life of patients receiving RT-PEPC treatment   "
176351|NCT00151294|"     Emotionally labile, depressed participants with multiple sclerosis treated with escitalopram     will have a greater reduction in emotional lability scores and in their psychological     distress scores than those who are randomized to receive placebo.   "
176352|NCT00151307|"     The purpose of this study is to evaluate the effects of maintaining adequate cerebral oxygen     saturation (over 40%) on patients undergoing cardiac surgery. Effects on neuropsychological     outcome, length of ICU stay, and length of hospital stay will be measured.   "
176353|NCT00151320|"     Primary Objective:      To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when     administered in combination with CHOP + Rituximab to patients with previously untreated     diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL)      Secondary Objectives:      To assess the response rate (overall and complete), event-free survival and overall survival     with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle     cell lymphoma (phase II component)      Treatment:      Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles      Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)      VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of     VELCADE will be determined by the following dose escalation schedule:      Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0)     0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4   "
176354|NCT00151333|"     To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 in     subjects with mild to moderate Alzheimer's disease.   "
176355|NCT00151346|"     The purpose of this study to compare the use of spinal-epidural versus traditional labor     epidural on maternal and fetal effects. The hope is to determine the safest and most     effective epidural method of relieving pain during labor.   "
176356|NCT00151359|"     Our research has shown that pressure sensation from the soles of the feet (plantar     mechanoreceptors) plays an important role in controlling several key aspects of balancing     reactions, particularly during compensatory stepping . As a result, age-related loss of     plantar pressure sensation, which is very common, can lead to impaired control of these     reactions. However, we have shown that it is possible to compensate for balance impairments     resulting from this loss of sensation by using special footwear insoles to facilitate     sensation from the perimeter of the sole. To date, we have demonstrated the feasibility of     this approach in laboratory studies, and we have obtained a U.S. patent for the design     concept. However, it remains to be determined whether the benefits of the footwear persist     over the long term, or whether there is a habituation of the effect. Also, we need to     determine whether there are any practical problems associated with wearing such footwear,     e.g. due to discomfort or irritation of the skin.   "
176357|NCT00151372|"     Approximately 20% of patients with chronic obstructive pulmonary disease (COPD) have major     depression, a condition that contributes to suffering but also to poor treatment adherence     leading to increased disability and morbidity. This study investigates the effectiveness of a     care management intervention aimed at facilitating adherence to a treatment algorithm based     on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators     hypothesize that this intervention, in comparison to usual care, will increase the     prescription of adequate antidepressant treatment by physicians, enhance treatment adherence     by patients, and reduce depressive symptoms, suicide ideation, and disability at a 28-week     follow-up period.   "
176358|NCT00151385|"     This investigation will utilize a systematic determination of anti-FVIII antibody specificity     in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment     with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of     current or prior FVIII inhibitor will be included for comparison. The objective of this study     is to describe the patterns of antibodies and associated epitopes in the study population.   "
176359|NCT00151398|"     The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of     lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.   "
176360|NCT00151411|"     The purpose of this study is to determine if the combination therapy of lifestyle     intervention and use of Metformin together will improve ovulation induction and     hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and     adolescent females.   "
176361|NCT00151424|"     Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by     Positive symptoms (symptoms that should not be there, inability to think clearly, to     distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or     absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and     relate to others). Other symptoms include reduced ability to recall and learn new     information, difficulty with problem solving, or maintaining productive employment. The     symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily     dopamine and serotonin, which enables brain cells to communicate with each other.      Asenapine is an investigational drug that may help to correct the imbalance in dopamine and     serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a     comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that     complete this trial will have the option of continuing in an additional one year extension     trial.   "
176362|NCT00151437|"     The purposes of this study are: 1) to provide SOMAVERT for compassionate use to patients with     acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the     safety and tolerability of SOMAVERT.   "
176363|NCT00151450|"     The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the     treatment of generalized anxiety disorder.   "
176364|NCT00151463|"     The Quality of Erection Questionnaire (QEQ) is a new questionnaire that was developed to     assess erectile attributes in men with erectile dysfunction. The study objective is to     validate the Quality of Erection Questionnaire (QEQ) through the evaluation of subject     responses to the QEQ regarding the quality and hardness of erections at baseline compared to     subject responses post 6 and 10 weeks dosing with Viagra (sildenafil citrate).   "
176365|NCT00151476|"     This is a registry-based observational study assessing clinical outcomes in FAP patients     receiving celecoxib compared with historical/concurrent registry patients who have not     received celecoxib.      Both retrospective and prospective data will be utilized. No sampling methods apply.   "
176366|NCT00151489|"     The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin     reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if     different dosages work better (reduce pain and mild to no side effects) for different people.   "
176367|NCT00151502|"     The purpose of this study is to find out if atovastatin, when taken with a cholinesterase     inhibitor, is effective for treating Alzheimer's disease.   "
176368|NCT00151515|"     The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil     formulation in males for the treatment of pattern hair loss. The secondary purpose is to     evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for     the treatment of pattern hair loss and to obtain the safety data on the investigational     product when used twice daily for up to one year.   "
176369|NCT00151528|"     The main purpose of this protocol is to evaluate the long-term safety of pregabalin in     patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive     open-label pregabalin therapy.   "
176370|NCT00151541|"     The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel,     (DTG) twice daily in combination with once daily vehicle control, adapalene gel 0.1% or     benzoyl peroxide gel 4%. The second objective of the study is to determine dapsone exposure     after co-administration of DTG 5% with vehicle control, adapalene or benzoyl peroxide gel.   "
176371|NCT00151554|"     According to current evidence and psychological theorizing, the provision of information     seems to be a promising way to reduce the anxiety of patients that is related to their     scheduled ICU stay. An ICU-specific information program will be investigated in a randomized     controlled clinical trial involving 120 patients undergoing elective open heart surgery and     20 patients undergoing abdominal surgery. It is expected that the patients in the test group     will experience less anxiety and ICU related discomfort than patients in the control group.   "
176372|NCT00151567|"     Ureteral stones have an important place in daily urological practice, usually causing acute     episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to     evaluate whether repeated administration of tamsulosin, a drug routinely used in the     treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone     in patients with pelvis ureterolithiasis.   "
176373|NCT00151580|"     In France, 50% of the hepatitis C virus carriers develop chronic clinical hepatitis, which     may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is     constant after transplantation. This recurrence usually causes chronic liver disease, in 50     to 80% of the patients. The interest of a long-term treatment with ribavirin alone after     transplantation has not been clearly demonstrated. The objective of our study is to evaluate     the efficacy of ribavirin as a maintenance treatment after a one year interferon-α /     ribavirin therapy on hepatitis C recurrence in the transplanted liver.   "
176374|NCT00151593|"     The aim of the study is to determine the efficacy and safety of a preservation solution in     liver transplantation. Its efficacy will be compared to the efficacy of other currently used     preservation solutions.   "
176375|NCT00151606|"     Nosocomial infections is a major problem in intensive care units due to both growing     incidence and pathogens implicated which become increasingly resistant to antibiotics.     According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for     approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to     methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission     of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our     study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S.     Aureus in intensive care units: either a reinforced isolation precautions protocol or a     standard precautions protocol.   "
176376|NCT00151619|"     Patients with congestive heart failure are usually treated with a combination of an ACE     inhibitor (or an AT1 blocking agent), a diuretic and a beta-blocker. However, some patients     remain symptomatic despite an optimal treatment with these drugs. In patients who also have     coronary heart disease, nitrates or some calcium-channel blockers could help to relieve     symptoms. Therefore, the aim of our study is to evaluate the additional benefit induced by a     second generation calcium-channel blocker, amlodipine, in patients with chronic heart failure     who remain symptomatic despite an optimal treatment.   "
176377|NCT00151632|"     The prevention of graft rejection after liver transplantation benefits nowadays from a     variety of newly developed immunosuppressive agents. This allows more flexible and     individualized immunoprophylaxis and gives an opportunity to reduce the long-term side     effects (hypertension, renal failure, diabetes, etc.) of immunosuppression. The purpose of     this study is to evaluate, in liver transplanted patients, if low doses of tacrolimus, given     in combination with mycophenolate mofetil, can result in a lower rate of long-term side     effects without increasing the rate of graft rejection.   "
176378|NCT00151645|"     Renal cell carcinoma represents today 3% of the solid tumors of the adult. Their bad     prognosis is due to the frequency of metastasis and the resistance to chemotherapy.     Immunotherapy (interferon-α, interleukin-2) has shown some good results but an important     toxicity. In our study, we evaluate the response to a new therapeutic strategy which combines     an injection of patient's own activated lymphocytes to a classic immunotherapy with     interferon-α and interleukin-2.   "
176379|NCT00151658|"     The purpose of this study is to evaluate the clinical and angiographic outcome of     implantation of stents eluting or not eluting Sirolimus in patients with complex coronary     artery lesions suitable for percutaneous coronary intervention.   "
184306|NCT00254787|"     The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release)     quetiapine in a rapid escalation scheme with to the current approved label titration.   "
176380|NCT00151671|"     Cirrhotic patients undergoing hepatic resection have a mortality rate near 10%, and 30 to 70%     of them develop severe complications. These failures are mainly due to hepatic insufficiency.     Studies have already shown benefits of oral nutritional supplements in ORL, digestive, and     cardiac surgery. We aimed to ascertain whether this nutritional, immune-enhancing     supplementation, administered 7 days before and 3 days after surgery, could improve liver     function and postoperative host defences in patients with liver cancer resection.   "
176381|NCT00151684|"     The purpose of this study is to explore diazoxide efficacy in treatment of obese men and     assessment of maximal insulin suppression in obese men without hyperglycaemia.      Obesity is associated with markedly elevated plasma insulin levels throughout the day. The     concept is that obese subjects predominantly develop lean tissue resistance against the     glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and     antilipolytic effects of insulin in adipose tissue. According to this theory, suppression of     hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion,     might be useful to treat obesity because it will help to reverse the process of lipid     storage.   "
176382|NCT00151697|"     Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy     of the combination of glimepiride and short-acting insulin on weight control and glucose     control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal     oral treatment will be randomized to either the new combination treatment or twice daily     injections with a mixture of short- and longacting insulin or once-daily injection with a     basal insulin analog. The study will compare glucose control and weight gain during a year     after randomisation between the three treatments.   "
176383|NCT00151710|"     Congenital adrenal hyperplasia, an autosomal recessive condition, is mainly caused by     mutations in the gene 21-hydroxylase and is treated with glucocorticoids in a slightly     supraphysiological dose. Adult patients seem to be characterized by insulin resistance, which     may be caused by the glucocorticoids and/or the accompanying obesity. The hypothesis of this     study is that pioglitazone can improve insulin sensitivity and correlated cardiovascular risk     factors in this specific group of patients. This will be tested in a randomized,     placebo-controlled, cross-over trial; insulin sensitivity will be quantified by euglycemic     hyperinsulinemic clamp studies.   "
176384|NCT00151723|"     Subclinical hyperthyroidism is defined as the presence of serum free thyroxine (T4) and     triiodothyronine (T3) levels within the reference range and a reduced serum thyrotrophin     (TSH) level. Evidence is accumulating that it has important clinical effects. The SUBstudy is     a randomised, Dutch multicenter trial to study whether radioiodine treatment prevents the     development of atrial fibrillation and prevents decreases in bone mineral density in patients     with endogenous subclinical hyperthyroidism.   "
176385|NCT00151736|"     This is a Phase 2, multi-center, open label, randomized clinical study to evaluate the safety     and efficiency of SDX-101 in combination with chlorambucil (CLB) and chlorambucil alone in     Chronic Lymphocytic Leukaemia (CLL) patients. The study treatment period will be     approximately 24-26 weeks with a follow-up period of approximately 8 weeks. Following the end     of treatment, patients with a confirmed complete response, partial response or stable disease     will be followed for up to 2 years to assess time to disease progression. Approximately 80     patients with documented diagnosis of B-cell CLL by standard clinical and immunophenotyping     criteria will be enrolled into the SDX-101-03 study. This study is being conducted in the     following European countries: France, Germany, Poland, Sweden and the United Kingdom.   "
176386|NCT00151749|"     The purpose of the study is to see how safe and effective and tolerable the use of WelChol®     is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic     drugs   "
176387|NCT00151762|"     This extension study is designed to evaluate the long-term safety and tolerability of     colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.   "
176388|NCT00143377|"     The purpose of this study is to evaluate the effectiveness of Detrusitol (tolterodine     tartrate) SR, 4 mg once daily, on patient's perception of the symptoms of overactive bladder     and which of these bothersome symptoms are improved with treatment.   "
176389|NCT00143390|"     To verify the non-inferiority of exemestane compared to anastrozole in time to tumor     progression (TTP), the primary efficacy endpoint, in postmenopausal women with     advanced/recurrent breast cancer.   "
176390|NCT00143403|"     To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver     metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen,     compared to 5-FU/FA alone.   "
176391|NCT00143416|"     Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients     with acromegaly.   "
176392|NCT00151775|"     This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16     with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks     participants can continue to take olmesartan medoxomil (OM) for up to an additional 46 weeks.   "
176393|NCT00151788|"     The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid     arteries will be assessed using standard ultrasound techniques.   "
176394|NCT00151801|"     Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in     multiple sclerosis.      The role of oral estroprogestins in the pathogenesis and in the clinical course of the     disease is actually unknown.      The aim of the study is to investigate safety and tolerability of association of     estroprogestins in two different doses with interferon-beta 1a in patients with     relapsing-remitting multiple sclerosis.   "
176395|NCT00151814|"     Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with     hypertension in ages 12 months - 16 years   "
176396|NCT00151827|"     This is a study in hypertensive patients with mild to moderate renal impairment. The     antihypertensive efficacy of olmesartan medoxomil is compared to losartan.   "
176397|NCT00151840|"     The efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, in patients     with ITP will be assessed and compared with data obtained from literature.   "
176398|NCT00151853|"     The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who     received anticoagulant treatment and who had to undergo acute cardiac surgery with a     cardiopulmonary bypass (CPB).   "
176400|NCT00151879|"     Subjects enrolled in the SP615, SP756, or SP774 open-label extension (OLE) trials receiving     oral SPM 927 for at least 8 weeks and a stable dose of up to 3 antiepileptic medications may     participate in a research trial at approximately 30 locations.      Trial objectives include investigating whether iv SPM 927 is safe and well tolerated when     given twice daily for a short period of time and identifying the appropriate infusion     rate(s).      Subjects will receive SPM 927 as a 30-, 15- or 10- minute infusions twice daily for 2 - 5     days based on notification by the research doctor and subject choice. Subjects will remain on     the same stable dose as received in the OLE trial.      Trial procedures will include medical history update, physical/ neurological exams, ECGs,     blood /urine sample collections and seizure diary completion.      Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM     927.   "
176401|NCT00151892|"     Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of     the bowel becomes red and swollen. Over time, patients with this disease may experience acute     episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without     disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is     an experimental drug designed to gradually release 5-ASA into the areas of large bowel     associated with ulcerative colitis. This study will test the safety and efficacy of     mesalazine in keeping ulcerative colitis in remission.   "
176402|NCT00151905|"     Bronchiolitis is a common viral lung infection in infants. Standard treatment often includes     the use of inhaled medications which are usually first mixed with a standard salt solution.     Inhalation of a more concentrated salt solution (hypertonic saline) has been successfully     used to treat other types of lung disease in children and adults. The purpose of this study     is to see if using inhaled hypertonic saline helps infants with bronchiolitis get better more     quickly.   "
176403|NCT00151918|"     The purpose of this study is to assess phosphate reduction and control in patients with End     Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride   "
176404|NCT00151931|"     The purpose of this study is to assess phosphate reduction and control in patients with End     Stage Renal Disease treated with lanthanum carbonate   "
176405|NCT00151944|"     The purpose of this study is to test the long-term safety and tolerability of SPD476 in the     maintenance of ulcerative colitis remission.   "
176406|NCT00151957|"     This study will evaluate the long-term safety of MTS in the symptomatic treatment of children     aged 6-12 diagnosed with ADHD   "
176407|NCT00151970|"     This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6-     hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.   "
176408|NCT00151983|"     This study will assess the safety and tolerability of MTS while attempting to establish the     appropriate starting dose for subjects previously on an existing long-acting methylphenidate     product.   "
176409|NCT00151996|"     The purpose of this study is to assess the safety and tolerability of administering SPD503     (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for     treatment of ADHD in children and adolescents aged 6-17   "
176410|NCT00152009|"     The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine     hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged     6-17   "
176411|NCT00152022|"     The purpose of this study is to assess the safety and effectiveness of SPD465 compared to     placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also     look at how SPD465 affects the participants sleep and how they perceive their quality of     life.   "
176412|NCT00152035|"     The purpose of this study is to assess the safety and effectiveness of SPD465 in the     treatment of ADHD. The study will also look at how SPD465 affects sleep.   "
176413|NCT00152048|"     The purpose of this study is to evaluate whether regular use of eflornithine 11.5% cream in     treating women with facial hair will induce skin damage (atrophy) on the face and/or forearms   "
176414|NCT00152061|"     In this study the researchers will be enrolling patients who are failing their current     antiretroviral regimen who also have resistance to 3TC or FTC. Patients will have their     current antiretroviral regimen changed based on resistance testing and also be randomly     assigned to either include, or not include 3TC/FTC in this new regimen. The purpose of the     research is to investigate whether the change in therapy results in a decrease in the amount     of virus particles and an increase in the CD4 cell count. In addition the researchers are     investigating the relationship between the existence of resistance and the rate of decrease     in viral load, and also to determine if continuing 3TC/FTC (despite being resistant to the     medications) has any effect on the rate of decrease of viral load, or effect on CD4 counts.   "
176415|NCT00152074|"     The purpose of this study is to determine the effect of a modest reduction in salt intake on     blood pressure in white, black and Asian individuals with hypertension or prehypertension,     and also to determine whether a modest reduction in salt intake has beneficial effects on the     surrogate markers of target organ damage in cardiovascular disease.   "
176416|NCT00152087|"     Surgical resection of the affected liver offers the best chance for disease-free survival in     patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease     which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable.     The objective of treatment with TheraSphere is to selectively administer a dose of     radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely     ineffective.   "
176434|NCT00153855|"     The purpose of the study is to detect structural brain changes using MRI and to correlate     these findings with neurodevelopmental assessments in two-year old children previously     enrolled in the NIH sponsored trial of inhaled Nitric Oxide (iNO) for the prevention of     Chronic Lung Disease in preterm ventilated infants. It is hypothesized that this imaging will     identify children with previously undiagnosed brain abnormalities and that the presence of     structural abnormalities will be associated with deficits in motor, cognitive, and     neurosensory development.   "
176435|NCT00153868|"     This is a web-based pilot study to evaluate the association between the treatment of anemia     with darbepoetin alfa (aranesp) and the clinical benefits in symptom palliation, improved     functional status and quality of life in patients with cancer. The feasibility of web-based     assessments and data capture will be evaluated.   "
176417|NCT00152100|"     Treatment for severe combined immunodeficiency (SCID) is a medical emergency. A stem cell     transplant (immature blood cells that can make other blood cells) from a (MSD) matched     sibling donor (brother or sister who is a match for your child's immune (HLA) type),     usually results in complete correction of immune function. However, most patients lack a     matched sibling donor, requiring the use of an alternate donor source.      Transplantation of cells from haploidentical family donors (typically parents) has resulted     in immune system correction in the majority of SCID individuals. However, only 65-80% of     patients survive greater than one year after this procedure. Failure results from     life-threatening infections, graft versus host disease (GvHD) or post-transplant     treatment-related effects. Also, for patients that survive beyond one year, B-cell (type of     blood cell that fights infection) and natural killer cell function (cell that attacks     infections and cancer cells) frequently fail to work, resulting in the need for long-term     treatment with intravenous gamma-globulin (IVIg).      In this study, in an effort to restore the overall cell function in patients with SCID,     researchers will use a highly purified CD133+ hematopoietic cell graft (stem cell transplant     without many mature donor white cells, called T-cells) obtained via use of the Miltenyi     CliniMACS device, a device not FDA approved.   "
176418|NCT00153647|"     The primary aim of the study is to increase the success rate of cecal intubation in first     colonoscopy and in repeated colonoscopy for the first failed procedure. The secondary aims     are to assess the procedure time, the terminal ileum intubation rate, the endoscopist     satisfaction score, the patients' acceptance, the complication rate of these two procedures,     and the intravenous sedative drugs used.   "
176419|NCT00153660|"     The aim of this study is to compare celecoxib plus a PPI (esomeprazole) versus naproxen plus     a PPI (esomeprazole) in preventing recurrent ulcer bleeding in arthritis patients with a     history of ulcer bleeding who require concomitant ASA. We hypothesized that among patients     with a history of ulcer bleeding who require concomitant ASA, celecoxib plus esomprazole     would be superior to naproxen plus esomeprazole for the prevention of recurrent ulcer     bleeding.   "
176420|NCT00153673|"     The purpose of this study is to compare the effect of Famotidine plus a COX-2 inhibitor     (celecoxib) with Famotidine plus dologesics in ulcer healing in arthritis patients.   "
176421|NCT00153686|"     To compare the diagnostic yield of mesenteric angiogram with CE in patients with active     obscure GIB.   "
176422|NCT00153699|"     We test the hypothesis whether topiramate narrows the angles which may render Asians more     likely to suffer from acute angle closure glaucoma.   "
176423|NCT00153712|"     The aim of this study is to study the natural history of the ulcer healing while on proton     pump inhibitors (PPI) and the ulcer recurrence without acid suppression therapy of     Non-steroidal Anti-inflammatory Drugs (NSAID), non-Helicobacter pylori (HP) bleeding ulcer     patients.   "
176424|NCT00153725|"     The aim of the study is to investigate whether intravenous infusion of pantoprazole     (Pantoloc) is effective in preventing recurrent bleeding in patients who present with acute     ulcer bleeding and continue to use aspirin   "
176425|NCT00153738|"     This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol     metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12     weeks of supplementation.   "
176426|NCT00153751|"     To test the efficacy of herbal medicine in relieving symptoms and change of quality of life     of patients with IBS.   "
176427|NCT00153764|"     The goal of the study is to evaluate the effectiveness of a new one-a-day Cooper complete     vitamin supplement with or without a combined omega-3 fatty acid supplement on selected     clinical risk factor measures. Participants taking the Cooper Complete one-a-day vitamin plus     omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and     C-reactive protein than those taking the other supplements.   "
176428|NCT00153777|"     The purpose of the study is to determine the effect of cellulose sulfate on the transmission     of HIV to women via vaginal intercourse. The secondary objectives are the effect on the     transmission of gonorrhea and chlamydia via the same route.      The study hypothesis is that there will be no effect.   "
176429|NCT00153790|"     The primary aim is to examine whether the intake of PhosphoLEAN is effective in aiding a     cohort of women in losing weight. Participants taking the supplement will have significantly     greater improvement in study outcomes than those taking the placebo.   "
176430|NCT00153803|"     This is a national, randomized, web-based, double-blind study to determine whether erlotinib     (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with     inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic     radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated     agent following concurrent chemoradiation and prior to the emergence of drug resistance will     prolong the progression-free survival by 40% (10 months → 14 months).   "
176431|NCT00153816|"     Extensive experimental and observational data suggest that intake of calcium and of vitamin D     exert protective effects on colorectal neoplasia. Building on their previous work, the     investigators will investigate the chemopreventive effect of vitamin D in the large bowel, to     study whether calcium with vitamin D is more effective than calcium alone, and to confirm     their positive finding regarding calcium. The goal of this study is the development of     chemopreventive combinations that will reduce risk of colorectal neoplasia sufficiently to     permit the lengthening of surveillance intervals in most patients and to clarify important     issues regarding the mechanisms of colorectal carcinogenesis and chemoprevention.   "
176432|NCT00153829|"     The purpose of the study is to determine whether the quality of life of patients with     multiple chronic conditions cared for by primary care physicians will improve due to the     introduction of a chronic illness management intervention.   "
176433|NCT00153842|"     The primary aim is to evaluate the safety (Phase I components) of administering bexarotene     (Targretin®, LGD1069) oral capsules in combination with two Taxol® and carboplatin     (Paraplatin®) schedules to patients with stage IIIB and IV non-small cell lung cancer. This     study will also evaluate the preliminary efficacy (Phase II component) of bexarotene oral     capsules in combination with the weekly Taxol® schedule and carboplatin in these patients.   "
176710|NCT00147992|"     This study is an evaluation of the survival of the implants and bridges, quality of     prosthetic work and patient satisfaction after immediate loading of the implants in a totally     edentate upper and lower jaw.   "
176436|NCT00153881|"     The primary objective is to determine the maximum tolerated dose of oral capecitabine, in     combination with fixed doses of weekly docetaxel, and concurrent thoracic radiation for the     treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal     junction.   "
176437|NCT00153894|"     The purpose of this study is to determine whether an exercise program comprised of strength     and endurance training will lower fasting insulin levels in a group of breast cancer     survivors. Insulin may be involved in the risk of breast cancer recurrence.   "
176438|NCT00153907|"     The purpose of this study is to find the highest dose of capecitabine and oral navelbine that     can be given without causing severe side effects, and to determine the safety, tolerability,     and effects (good and bad) of capecitabine given with oral navelbine to patients with     advanced breast cancer.   "
176439|NCT00153920|"     Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple     myeloma in patients who have received at least two prior therapies and have demonstrated     disease progression on the last therapy. This study will determine if Velcade is effective in     treating patients with multiple myeloma that have had no prior treatment for the disease. We     will also use whole-genome scanning to identify drug response biomarkers in bone marrow     samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and     after treatment with Velcade.   "
176440|NCT00153933|"     The purpose if this study is to evaluate the side effects of the combination of bortezomib     and Revlimid (CC-5013) in patients with relapsed and relapsed/refractory multiple myeloma.   "
176441|NCT00153946|"     Edaravone, a free radical scavenger, is a novel neuroprotective agent, and argatroban is a     selective thrombin inhibitor. Both the drugs were approved by the Japanese Government, and     have frequently been used for the treatment of acute brain infarction in Japan. The effect of     combination therapy of these drugs, however, has not yet been elucidated. This study will     test the safety and efficacy of the combination therapy with these agents in patients with     acute non-cardioembolic and non-lacunar ischemic stroke.   "
176442|NCT00153959|"     The aim of the study was to compare the effectiveness of acute psychiatric day care to     conventional inpatient care within a cross-national multi-site randomised controlled trial.   "
176443|NCT00153972|"     The study is designed to measure the difference of dopamine turnover rate measured by     Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with     cabergoline and levodopa for 3 months.      The study protocol includes an initial Fluoro-Dopa-PET scan before treatment and after three     months double-blind treatment with cabergoline or levodopa.      The hypothesis for this study is that the dopamine turnover rate is a more sensitive marker     for the early diagnosis of Parkinson's disease compared to the standard Fluoro-Dopa-PET     measuring only the Fluoro-Dopa uptake into the striatum.      For the interventional part of the study, the hypothesis is that levodopa has larger effects     on striatal dopamine turnover compared to dopamine agonists by providing more dopamine     precursor. Enhancement of compensatory mechanisms for dopamine loss in early PD such as     increased dopamine turnover could have several beneficial implications such as improvement or     prolongation of symptomatic treatment responses, but might also produce therapeutic problems     such as the development of levodopa-induced motor complications.   "
176444|NCT00153985|"     The purpose of this study is to determine if treatment with reduced-dose busulfex,     fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor     stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating     blood counts. In addition the incidence and severity of side effects and of graft vs. host     disease (GVHD) will be monitored.   "
176445|NCT00153998|"     General Objectives:        -  To test the feasibility of neoadjuvant treatment with cetuximab/chemotherapy followed by          liver resection        -  To determine the optimal combination (cetuximab/FOLFOX versus cetuximab/FOLFIRI) for          further trials in preoperative chemotherapy   "
176446|NCT00154011|"     The study is designed to test the hypothesis in healthy subjects that the oral antidiabetic     drug rosiglitazone provides additional vascular relaxing or modulating effects in addition to     its blood glucose level reducing ability.   "
176447|NCT00154024|"     Vascular responses to angiotensin II and histamine are compared before and after 30 days of     systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.   "
176448|NCT00154037|"     The study is designed to test the hypothesis in healthy subjects that candesartan and     pioglitazone provide additional vascular relaxing or modulating effects in addition to their     blood-pressure and blood glucose level reducing ability, respectively.   "
176449|NCT00154050|"     The study is designed to test the hypothesis that high dose candesartan treatment compared to     quinapril is able to reduce intima hyperproliferation and the restenosis rate after stent     angioplasty in peripheral occlusive artery disease.   "
176450|NCT00154063|"     This was a 22-week, prospective, randomized, double-blind, placebo-controlled, multicenter,     parallel-group study that included a 4-week Baseline Phase at the beginning and a 4-week     single-blind placebo Safety Phase at the end of the study.   "
176451|NCT00154076|"     To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in     Untreated Epilepsies   "
176452|NCT00154089|"     The primary objective of this study is to determine pilot safety and efficacy data for a     topical formulation of EM-1421 applied to the cervix of patients with CIN 1, 2, or 3.   "
176469|NCT00154310|"     The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen     with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and     well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium     (EC-MPS) and cyclosporine microemulsion, but results in better renal function.   "
176470|NCT00154323|"     Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania,     grandiose delusions, and suicidality. This study will investigate the efficacy a safety of     oxcarbazepine in the treatment of patients with bipolar disorder type I or II.   "
176471|NCT00154336|"     Imatinib is a member of a new class of drugs known as signal transduction inhibitors. The     purpose of this study is to evaluate the efficacy, safety and tolerability of imatinib in the     treatment of rheumatoid arthritis in combination with methotrexate in patients who do not     respond satisfactorily to standard treatment, e.g. methotrexate.   "
176453|NCT00154102|"     Drugs used against cancer work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together     with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer     ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known     whether giving combination chemotherapy together with cetuximab is more effective than     combination chemotherapy alone. This open-label trial investigates the effectiveness of     cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil     (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line     setting, compared to the same chemotherapy alone on patient expressing the epidermal growth     factor (EGF) receptor.      Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to     either receive the combination chemotherapy alone or with cetuximab (open-label study) and     will then be treated until progression of the disease or unacceptable toxicity occur. Regular     efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study     together with regular safety assessments (e.g. safety labs). An independent Safety Board of     experts will also monitor safety data.      After participant discontinuation from the trial, regular updates on further treatments and     survival status will be requested from the investigator.      The entire study (from the first patient entering the study to the last collect of follow-up     information) is 4-5 years long.   "
176454|NCT00154115|"     Prospective, randomized, double blind study investigating the efficacy of levosimendan in     heart failure after cardiac surgery.      Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and     morbidity and may improve survival after heart valve surgery.   "
176455|NCT00154128|"     The study was designed to investigate a possible influence of an occlusal stabilization     splint on the body posture in TMD cases and controls. Interocclusal appliances or occlusal     splints are therapeutic devices that are most frequently used in the treatment of TMD.     Changes of the mandibular position and occlusal equilibrations are assumed to have an impact     on the general body posture.   "
176456|NCT00154141|"     A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding     during vascular procedures.   "
176457|NCT00154154|"     The aim of this study is to evaluate the clinical and cost effectiveness of Dialectical     Behavior Therapy (DBT) for chronically suicidal behavior in individuals diagnosed with     borderline personality disorder (BPD). Recent investigations of DBT have yielded positive     results and have challenged the widely held opinion that the prognosis for this condition is     poor. This study will consist of a two-arm randomized controlled trial that will compare DBT     with a General Psychiatric Management (GPM) condition consisting of a structured algorithmic     medication intervention plus psychosocial counseling. One-hundred and eighty participants     will be randomly assigned to either DBT or to the GPM condition. Clinical outcomes will be     assessed by changes in: (1) parasuicidal behaviour; (2) treatment retention; (3) psychiatric     symptomatology; (4) anger expression; (5) social functioning and (6) health status. Cost     outcomes will include an analysis of health service utilization. Clinical and cost     evaluations will occur at 4-month intervals over the course of the one-year treatment and     over a two-year follow-up.   "
176458|NCT00154167|"     The purpose of this study was:        -  to determine if NV-101 accelerates recovery from numbness compared to placebo        -  to evaluate safety of NV-101   "
176459|NCT00154180|"     The study will examine the effects of estrogen and progesterone on the development of     atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the     menopausal transition.   "
176460|NCT00154193|"     The main purpose of this study is to identify cyclosporine C2 levels during 12 months     treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine     blood samples, and retrospectively correlate C2 levels to outcome (renal function and     incidence of acute rejections)   "
176461|NCT00154206|"     The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with     Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients.     Safety and doses variations are also evaluated.   "
176462|NCT00154219|"     The purpose of this study is to evaluate the efficacy, tolerability, and safety of the     investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip     osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2     selective nonsteroidal anti-inflammatory drugs [NSAIDs]).   "
176463|NCT00154232|"     The aim of the study is to assess the short-term benefit of the combination of basiliximab,     EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute     rejection in a population of de novo renal transplant patients at potential high risk of DGF.   "
176464|NCT00154245|"     The study is a one-year prospective, open-label, safety and efficacy study. De novo renal     transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and     corticosteroids .The study will consist of a 12-month open-label treatment period on EC-MPS.   "
176465|NCT00154258|"     Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long     term treatment of clozapine in patients with treatment-resistant schizophrenia.   "
176466|NCT00154271|"     The study compares the efficacy of an aggressive versus a moderate initial antihypertensive     regimen to reduce blood pressure in patients with Stage 2 hypertension. Additionally, the     study examines the effects of blood pressure reduction on the levels of high sensitivity     hsCRP. Although the main goal is to determine the overall effect of blood pressure reduction     on hsCRP levels, analysis will also evaluate whether an aggressive antihypertensive regimen     is more effective than a moderate one in reducing hsCRP levels.   "
176467|NCT00154284|"     The purpose of this study is to evaluate the safety and efficacy of everolimus in combination     with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney     transplant recipients.   "
176468|NCT00154297|"     The purpose of this study is to evaluate if the delayed administration of everolimus could     reduce the everolimus associated anti-proliferative complications (e.g. wound healing     disorder) while maintaining efficacy, when compared to the immediate administration of     everolimus in de novo renal transplant patients.   "
176711|NCT00148005|"     Investigation of the prevalence etiology and therapy of micturition disorders of children     with a mental and/or motoric disability   "
176473|NCT00154362|"     Conduct disorder is a group of psychiatric symptoms that can include clinical characteristics     of impulsivity and aggressive behavior. This study will investigate the efficacy a safety of     oxcarbazepine in the treatment of adolescents with conduct disorder.   "
176474|NCT00154375|"     This is a Phase III study comparing Imatinib mesylate and hydroxyurea combination therapy     with hydroxyurea monotherapy in patients with temozolomide resistant progressive     glioblastoma.   "
176475|NCT00154388|"     Exploratory study to examine the effect(s) of Imatinib mesylate treatment on life threatening     rare diseases with known associations to one or more Imatinib mesylate -sensitive tyrosine     kinases, and to identify the contribution of specific protein tyrosine kinases (PTKs) of that     specific disease.   "
176476|NCT00154401|"     This trial is conducted in Europe. The trial is designed to show the effect of treatment with     liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2     diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The     trial is a multi-national trial with treatment concealed to participating subjects,     investigators and the sponsor. Treatment allocation is random with equal chance of being     assigned to each group.   "
176477|NCT00154414|"     This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of     treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese     subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily     in the evening. The trial is a multi-national trial with treatment concealed to participating     subjects, investigators and the sponsor. Treatment allocation is random with equal chance of     being assigned to each group.   "
176478|NCT00154427|"     This trial is conducted in Africa, Asia, Europe, South America and the United States of     America (USA).      The trial is planned to investigate the safety and efficacy of NovoSeven® in the management     of post-operative bleeding in patients following cardiac surgery.   "
176479|NCT00154440|"     The first objective of this study is to confirm the results of complete remission of     low-grade gastric MALT lymphoma stage IE & II1E after H. pylori eradication on a larger     number of patients (HELYX Part I). If there is no response to the antibiotic therapy, the     role of radiotherapy on the course of gastric MALT lymphoma will be investigated as a     consecutive therapeutic option for patients that are H. pylori- negative, t(11;18)-positive     or failure candidates after eradication therapy. Furthermore, the method of radiation, and     the radiation dose will be investigated and standardized. HELYX PART II is therefore a     randomized equivalent study comparing the standard dose of 36Gy vs. a reduced dose of 25.2Gy     locoregional. Additional molecular genetic analysis will be performed to try to understand     pathogenetic mechanisms of lymphomagenesis.   "
176480|NCT00154453|"     Orbicularis oculi muscle is a key structure in the peri-orbital anatomy and is responsible     for the major changes of aging in this area. Peri-orbital rejuvenation has been an issue of     great interest in plastic surgery. We believe that understanding the age-related     histomorphometric changes in orbicularis oculi muscle is important for improving the current     rejuvenation techniques or developing the new ones. Nevertheless, a study focusing on this     topic has never been performed before, simply because it is difficult and dangerous to     perform needle biopsy on orbicularis oculi muscle.   "
176481|NCT00154466|"     One emerging concept is that some form of injury or inflammation is a prerequisite for the     success of circulating-cell participation in differentiated tissue structure and function.     Once reperfusion is achieved in acute myocardial infarction, an intense inflammatory cascade     is unleashed.      The architecture of the left ventricle rearranges, leading to ventricular remodeling. The     homing processinvolves stem cell migration to the sites of injury or ischemia, which     provides an environment that is favorable to growth and function. This microenvironment is a     stimulus for homing and differentiation of stem cells of the appropriate lineage. It     increases vascular permeability and expression of adhesion proteins like integrin, along with     homing receptors that facilitate the attachment, which is mediated by cell-to-cell contact     and chemoattractant release from local tissue injury.The migratory capacity of stem cells     might be dependent on natural growth factors such as vascular endothelial growth factor     (VEGF) , stromal cell-derived factor-1 (SDF-1)and stem cell factor (SCF).The expression of     VEGF ,SDF-1 and SCF is highly up-regulated in hypoxic tissue, supporting the hypothesis that     these factors may represent homing signals crucial to the recruitment of circulating     progenitor cells to assist the endogenous repair mechanisms in the infarcted tissue. This     study will examine whether cardiac rehabilitation increases the concentration of stem cell     factors released into the bloodstream and if these factors are correlated with the     improvement of heart function.   "
176482|NCT00154479|"     Cervical cancer is the most frequent neoplasm of women in Taiwan and in the world. It     influences about 2,700 women with about 1,000 women dying of cervical cancer each year and in     Taiwan. Human papillomaviruses (HPV) have been consistently implicated in causing cervical     cancer especially those high-risk types which have been strongly associated with cervical     cancer. In recent years, there has been compelling evidence that infection with human     papillomavirus (HPV) is a major etiologic factor in the development of cervical     intraepithelial neoplasia (CIN) and cervical carcinoma.      As in most virus-induced diseases, an adequate immune response is likely to play a key role     in the clearance of HPV infections and HPV-related lesions. This assumption is born out by     both epidemiological studies and animal models. Immune-compromised patients such as     HIV-infected women, organ transplant recipients, and patients suffering from other forms of     malignancies, are at a higher risk of developing CIN lesions and invasive cervical cancer.     Moreover, several studies establish the existence of natural HPV E7-specific cytotoxic T     lymphocyte (CTL) immunity in humans. Only a minority of women infected with oncogenic HPV     types develop CIN or cervical cancer. Indeed, the majority of CIN lesions do not progress or     even regress to normal cytology, indicating that other factors such as an inadequate immune     function are necessary for the development of progressive CIN lesions and cervical carcinoma.      Consequently, the HLA class I and II phenotypes may be correlated with an effective immune     response against HPV-associated cervical lesions. Differences in the recognition of foreign     antigens, such as those contributed by alleles at the HLA class I or II loci, might be     proposed to affect the risk of developing cervical cancer.      In the present proposal, the investigators would like to examine the HLA class I and II     associations among Taiwanese women with cervical neoplasia. The purposes of this proposal     are:        1. to address the relationships between the HLA class I and II haplotype, HPV infection,          and cervical cancer; and        2. to elucidate the immunologic responses to HPV type 16 in different HLA class I and II          haplotypes. It will help the investigators to identify which population of HLA genotypes          is more susceptible to HPV infection and progresses to invasive cervical cancer. The          results of this research will be very useful for the prevention and screening of          cervical cancer in the future.   "
176483|NCT00154492|"     This trial is conducted in Asia and Europe. The trial is planned to investigate the     effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active     variceal bleeding.   "
176712|NCT00148018|"     The primary objective of this study is to evaluate wether bortezomib and dexamethasone are     active in patients with relapsed Hodgkin's lymphoma.   "
176484|NCT00154505|"     The effects of lateral trunk supports (LTS) in special seating on the spinal alignment of 17     spinal cord injured (SCI) subjects with scoliosis were studied using bi-planar radiographs.     The LTS improved significantly the functional scoliotic spinal alignment in the frontal and     sagittal planes regardless of the severity of scoliosis.   "
176485|NCT00154518|"     The purpose of this study is to test whether the two MMPs can be up-regulated during     orthodontic treatment. Alveolar bone samples will be collected from partially impacted third     molars after orthodontic uprighting for different periods of time in volunteers.   "
176486|NCT00154531|"     Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. Though     Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin(DCP) are used as the tumor markers for     diagnosis of HCCs. Thus, these two markers are not good enough for the early detection of     small HCCs. To improve the survival, further investigations of the early diagnostic markers     are still needed.      SELDI is a proteomic profiling techniques in biomarker discovery. Its approach has been     successfully used to identify biomarkers of various cancers, such as prostate cancer, bladder     cancer, ovarian cancer, lung cancer, colon cancer, breast cancer and pancreatic cancer.      In this current project we will apply the SELDI technique to identify the HCC biomarkers.     Sera samples from the HCC patients and relevant controls will be collected. We hope that we     can find the new HCC biomarkers. If biomarkers of HCC are identified, this can be used to     clinical application for the possible early detection of HCCs.   "
176487|NCT00154544|"     Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. About     6000-8000 people died of this cancer every year in Taiwan. Though regular sonographic     examination can early detect small HCC and there are many therapeutic modalities for HCC, the     therapeutic results remains unsatisfactory. Though Alpha-fetoprotein (AFP) and des-γ-carboxy     prothrombin (DCP) are used as the tumor markers for diagnosis of HCCs, these two markers are     not good enough for the early detection of small HCCs. To improve the survival, further     investigations of the early diagnostic markers are still needed. In this current project, we     applied the proteomic method to identify the HCC biomarkers.   "
176488|NCT00154557|"     Judo is one of the possible items in our country to win the first prize in Olympics. However,     scientific research in this field is not enough to support the coaches to train the athletes.     Series of research should be planned and executed to help the coaches and to promote the     performance of our athletes. This is the first step of the serial research. The purposes of     this study are: in the first year, to find the correlations between the     physiological/psychological competitive abilities of the second/third year athletes and their     performance/injury status. And, the physiological/ psychological competitive abilities of the     first year athletes will be collected in the beginning of this year. And then, their     performance/injury status will be followed through the whole year and to the end of the     second year monthly. The purposes of this study in the second year are to find the causation     of the physiological/ psychological competitive abilities in the first year with the     performance/injury status in the second year.      The subjects of this study are from 4 senior high schools in the north part of Taiwan which     performed well in national judo competition in senior high schools in the past years. The     study designs are both cross-sectional and prospective. In the part of the second/third year     athletes, it is a cross-sectional design, and in the part of the first year athletes, it is a     prospective design. The physiological status will be assessed with their general fitness and     balance. The fitness test includes body composition, strength, power, endurance, agility,     coordination, balance, flexibility, and cardiopulmonary capacity. The psychological     competitive abilities will be assessed with a questionnaire. Injury and the possible causes     will also be collected with a questionnaire monthly. Finally, the data will be analyzed with     descriptive analysis, chi-square test, t-test and regression analysis to show their     characteristics, correlations and causations.   "
176489|NCT00154570|"     We hypothesize that gastric dysrhythmias may predispose the occurrence of gastroesophageal     reflux.   "
176490|NCT00154583|"     Cervical cancer is the most frequent neoplasm and the third in mortality rate of the     malignancies in women in the world. It results in about 200,000 women dying of cervical     cancer each year worldwide. The available forms of treatment - surgery, radiation therapy,     and chemotherapy - are all cytoreductive treatment modalities, so, in addition to killing     cancerous cells, healthy cells are also destroyed in the process. Indeed, there is a need to     decrease the incidence of cervical cancer and develop better forms for its treatment.      Human papillomaviruses (HPV) have been consistently implicated in causing cervical cancer     especially those high-risk types (HPV 16, 18, 31, 45) which have been strongly associated     with cervical cancer. HPV 16 was found in more than 50% of cervical cancer tissues. So, the     host immune response plays an important role in determining the regression of a cervical     abnormality or persistence and progression to a malignancy via targeting HPV.      The ideal cancer treatment should be able to eradicate systemic tumors at multiple sites in     the body while having the specificity to discriminate between neoplastic and nonneoplastic     cells. In this regard, antigen-specific cancer immunotherapy represents an attractive     approach for cancer treatment. By cooperating with Dr. TC Wu at the Johns Hopkins Medical     Institutes, the investigators have recently developed some E7-specific cancer vaccines of     different strategies such as DNA, or replication-defective SINrep5 virus. They found that     these E7-chimeric DNA vaccines are capable of preventing and treating the growth of murine     model tumors expressing E7. These positive results from the preclinical murine models have     encouraged the investigators to focus on the development of a cancer vaccine and     immunotherapy and apply these vaccines to human subjects. However, it is very important to     set up various E7-specific immunologic assays of human beings to evaluate the effects of a     cancer vaccine or immunotherapy in future clinical trials. So the investigators would like to     provide this proposal to address the development of HPV 16 E7-specific immunologic assays in     human beings. There are two main goals in this study. First, the investigators would like to     establish and compare the differences of HPV type 16 E7-specific immunologic responses     between the normal population, people with HPV infection, patients with cervical     intraepithelial neoplastic (CIN) lesions, and patients with cervical cancer. Second, they     would like to correlate the disease severity of cervical cancer with the immunologic     responses to HPV type 16 E7 antigen.   "
176491|NCT00154596|"     The purpose of this study is to investigate the infectious etiology of Kawasaki disease (KD);     a prospective household and case control study for Kawasaki disease will be done. The     investigators will enroll Kawasaki disease cases who have at least five of the following     manifestations:        1. fever for over 5 days        2. neck lymphadenopathy        3. lip fissure and/or strawberry tongue        4. skin rash        5. nonpurulent bulbar conjunctivitis        6. palm/sole erythema and induration followed by desquamation, or coronary artery aneurysm          with less than 5 of the above manifestations (atypical Kawasaki disease)      The KD cases will receive virological (virus isolation from the blood, throat swabs and     rectal swabs or stool, gene chip for possible viruses from stored RNA and DNA), bacterial     (blood, throat swabs and stool: bacterial culture and stored strain for further toxin or     superantigen detection), and serological (Mycoplasma pneumoniae, Chlamydiae pneumoniae, ASLO,     HHV6, EV71, peptide library approach for auto-antibody or pathogen-related antibody, stored     serum for further workup) workup. Stored DNA from the blood will also be performed.   "
176492|NCT00154609|"     We, the investigators at National Taiwan University Hospital, have determined the therapeutic     and toxic effects of the traditional herb on the ovariectomized Wistar rat.      The final years will determine its effects on the therapy of women who are over 45 years old     and postmenopausal with osteoporosis.   "
176562|NCT00155545|"     The purposes of this study are to use motion analysis techniques to study the biomechanical     interactions between the spine and the lower limbs in scoliosis patients with or without leg     length discrepancy (LLD) during activity; to investigate the effects of correction of LLD:     using foot orthosis on the functional scoliotic spinal curve and motion during functional     activity; and to test whether idiopathic scoliosis without LLD can be improved by     artificially creating a leg length discrepancy with a foot orthosis.   "
176493|NCT00154622|"     Work-related musculoskeletal disorders(MSD)are very common，which account for most of the     occupational compensation in U.S.A。According to the epidemiological surveys，injured sites are     frequent at low back，neck and shoulder and upper extremity。Although the MSD will not threaten     the lives，they result in discomfort，some cost much and decrease the productivity。There was     little study in our country to reveal the risk factors of medical utilization and disabling     of MSD。Therefore，we do not have well-established strategy of the assessment and treatment for     the workers who can not return to work。The purposes of this study are：1、To have sequential     surveys to find the prevalence，incidence and possible risk factors of work-related MSD of     employees in different industries and their medical utilization and disabled conditions。2、To     find the victims of work-related MSD from clinics，assess their disablement and if they return     to work and to find the factors those prevent them return to work。3、To develop individualized     work hardening programs for the victims who can not return to wok after treatment。The program     will be established according to their injuries and their work characteristics。   "
176494|NCT00154635|"     A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of     DCB-AD1 in Patients with Mild to Moderate Alzheimer’s Disease. Because of the limitation of     the sample size we could expect but a positive trend of the efficacy unless the effect size     of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical     investigation such as a phase III study should be carried out in an even larger scale. We     also should be able to obtain valuable experience on the adverse effect of prolonged     (24-week) use of Fo-ti.   "
176495|NCT00154648|"     This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic     resonance angiography (CE-MRA) of the arteries.   "
176496|NCT00154661|"     we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1     production in human glomerulonephritis.   "
176497|NCT00154674|"     Hypothermic resuscitation is proven to be benefit to the cardiac origin cardiac arrest     patients for it improve brain recovery dramatically. However, traditional cooling devices and     methods, most external cooling methods, include ice blanket, cooling helmet, or ice packing     lower the body temperature slowly or inefficiently which make many emergency physicians     hesitate to perform hypothermic resuscitation. To improve and promote the practice of     hypothermia resuscitation, more efficient temperature control method is necessary. We conduct     this clinical trial to evaluate the safety and feasibility of internal cooling catheter and     temperature regulatory device, which is approved by FDA in neurologic ICU for temperature     control, in the cardiac arrest patients.   "
176498|NCT00154687|"     The purpose of this study is to evaluate the efficacy of Weekly TP-HDFL in advanced     transitional cell carcinoma in terms of response rate and overall survival.   "
176499|NCT00154700|"     The primary objective of this study is to find out the response rate of twice weekly     paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma     patients who need palliative Chemotherapy.   "
176500|NCT00154713|"     The specific aims of this study are as follows:        1. Primary endpoint: to evaluate the clinical responses of vaccinated patients.        2. Secondary endpoint: to evaluate the safety of this treatment and the immune responses          against CEA before and after the treatment   "
176501|NCT00154726|"     The purpose of this study is to evaluate the efficacy,response rate,time to treatment     failure,overall survival,toxicities of Paclitaxel-HDFL regimen in locally advanced/inoperable     and recurrent/metastatic gastric cancers. To evaluate the resectability and relapse pattern     after potentially curative resection of neoadjuvant Paclitaxel-HDFL regimen   "
176502|NCT00154739|"     The purpose of this study is to evaluate the efficacy of gemcitabine/cisplatin versus     gemcitabine/epirubicin in Stage IIIB/IV NSCLC in terms of response rate and overall survival.   "
176503|NCT00154752|"     Based on the neurophysiology, it is well known that sympathetic nerves control the     ejaculatory function and bladder neck closure. In contrast, the parasympathetic nerves     control penile erection and bladder wall contraction. Because of the difference in cultural     background of the patients and training background of the physicians between Western and     Oriental Countries, the Western people did not believe in the efficacy of wide pelvic     lymphadenectomy. In the Oriental countries, due to the shortage of standardized facilities,     treatment protocol, and manpower, the concurrent preoperative chemoradiation therapy (CCRT)     of American style is currently not widely accepted. Therefore, the advantage and disadvantage     of these two treatment modalities for advanced rectal cancers need be further clarified. In     this project, we plan to randomly assign the patients into two groups: (1) concurrent     preoperative chemoradiation therapy (CCRT) + conventional surgery group; (2) wide pelvic     lymphadenectomy group. Thereafter, we plan to evaluate: (1) the anorectal function by     anorectal manometry and colonic transit time using radioopaque markers; (2) the micturition     function using urodynamic study; (3) the penile erection by RigiScan; and (4) the ejaculatory     function by clinical interview of the patients. Moreover, the various clinicopathologic     factors, including the depth of tumor invasion and the status of lymph node invasion, were     recorded in detail according to the guidelines recommended by the Japanese Society of     Coloproctology. Furthermore, we will evaluate the oncological results for these patients.   "
176504|NCT00154765|"     Therapeutic exercise is important to patients with knee osteoarthritis. Few studies reported     the effect of therapeutic exercise in proprioception for these patients. The purposes of this     study were to investigate the training effect of sling suspension exercises, as a     proprioception-training tool, for patients with knee osteoarthritis and further, to build up     an model of proprioception training.   "
176505|NCT00154778|"     The purpose of this study is to evaluate the response rate of Paclitaxel combination     chemotherapy with UFT and Leucovorin in patients with advanced gastric cancer.   "
176506|NCT00154791|"     We plan to conduct a phase I/II clinical trial using biweekly gemcitabine, oxaliplatin, and     48-hour infusion of high dose 5-FU/leucovorin to treat patients with advanced pancreatic     adenocarcinoma. In the phase I part, the maximum tolerable dose of oxaliplatin in combination     with biweekly gemcitabine 800 mg/m2 and 48-hour infusion of 5-FU 3000 mg/m2 and leucovorin     300 mg/m2 will be determined. In the phase II part, the efficacy and safety of the biweekly     chemotherapy with GOFL will be evaluated.   "
176507|NCT00154804|"     CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal     cancer.   "
176508|NCT00154817|"     1. This is a phase II study of radiotherapy for patients with locally advanced HCC.        2. Patients whose tumor(s) are not suitable for other local treatment, such as surgery,          trans-arterial chemoembolization (TAE), ethanol injection, or radiofrequency ablation.          will be enrolled.        3. Radical radiotherapy will be started after pre-treatment evaluation. The total dose of          RT will be 50Gy in 25 fractions to local tumor(s).        4. Dynamic contrast enhanced MRI and serum samples will be done at the following time          points to assess the change in tumor perfusion: (1) before the start of thalidomide          treatment; (2) 2weeks after radiotherapy begins; and (3) 1 month after radiotherapy          completes. DCEMRI will then be done every 3 months until disease progression.        5. The study was designed to evaluate the response rate and tolerability of radical          radiotherapy for locally advanced HCC. The sample size was determined by the expected          incidence of grade 4 toxicity and response rate of radiotherapy for locally advanced          HCC. Since the grade 4 toxicity of radiotherapy alone is 10%, the response rate is 60%          we need at least 12 patients to evaluate for the treatment.   "
176509|NCT00154830|"     Cerebral palsy (CP) is the most prevalent physical disabilities originating in childhood.     Crouch gait is a common gait abnormality in patients with cerebral palsy, which is common     treated with hamstring lengthening. This surgery can alter mechanical property of lower limb     and affected ability of generating force in hamstring, leading changes in functional     activities. Therefore, the first aim of this study is to investigate the effects of hamstring     lengthening on pelvis and hip control while performing functional activity, including level     walking and sit-to-stand.   "
176510|NCT00154843|"     Primary: To determine factors that affect absorption and serum levels of lycopene after     supplementation.      Secondary:        1. To evaluate general safety and tolerability of oral lycopene 15 or 30 mg per day for 12          weeks.        2. To determine lycopene effects on reducing serum levels of prostate specific antigen          (PSA) and on relieving lower urinary tract symptoms (LUTS) in relation to prostate          hypertrophy as evaluated by the International Prostate Symptom Score (I-PSS).   "
176511|NCT00154856|"     a further step of our current one-year NSC project, aiming to bridge the above-mentioned gap     by continuously monitoring the mechanical stimuli applied to the limb and callus, both     through experimental measurements and FEM calculations, and by correlating the observed     quantity and quality of the mechanical stimuli with the calculated stress and strain patterns     of the callus tissue.   "
176512|NCT00154869|"     The investigators' pilot study indicates that hepatitis C virus (HCV)- and hepatitis B virus     (HBV)-coinfected patients with predominantly active hepatitis C and those with predominantly     active hepatitis B may need different anti-viral regimens. Since in the majority of these     coinfected patients the hepatitis activity is more likely due to HCV than to HBV, the optimal     therapeutic regimen for HCV- and HBV-coinfected patients with predominantly active hepatitis     C will first be investigated. The combination therapy using pegylated interferons (IFNs) such     as PEG-IFN alfa-2a has been shown to have a superior efficacy than that using conventional     IFN in the treatment of monoinfected chronic hepatitis C. This new combination therapy might     also further enhance the treatment efficacy in HCV- and HBV- coinfected patients. The     investigators therefore propose to initiate a trial comparing the efficacy of pegylated IFN     plus ribavirin (RBV) in dual chronic hepatitis B and C versus that in chronic hepatitis C     only, for both HCV genotype 1 and 2/3 patients. The efficacy using a 24-week combination     therapy in the sustained clearance of serum HCV RNA is equivalent to that using a 48-week     combination therapy in patients with HCV genotype non-1 [Hadziyannis et al, EASL 2002]. A     48-week course of pegylated IFN and RBV combination therapy, in contrast, has been shown to     yield a better efficacy in the sustained clearance of serum HCV RNA in patients with HCV     genotype 1 than a 24-week combination therapy in western countries [Hadziyannis et al, EASL     2002; Poynard et al, 1998]. The primary objective of the current proposal is to investigate     and compare the efficacy of combination therapy using pegylated IFN plus RBV on the clearance     of serum HCV RNA in both dually infected patients with a dominant HCV infection and HCV     monoinfected patients. Therefore, in this proposal, the treatment duration will be 24 weeks     for HCV genotype 2/3 in patients with dual chronic hepatitis C and B and in patients with     monoinfected HCV, and will be 48 weeks for HCV genotype 1 in patients with dual chronic     hepatitis C and B and in patients with monoinfected HCV.   "
176513|NCT00154882|"     The primary endpoint of this phase II trial is the objective response rate of the stage I     (low-dose) regimen. The secondary endpoints include treatment-related toxicity, the change in     quality of life, progression free survival and overall survival.   "
176514|NCT00154895|"     To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the     rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.   "
176515|NCT00154921|"     Traditional biopsy requires the removal, fixation, and staining of tissues from the human     body. Its procedure is invasive and painful. Non-invasive in vivo optical biopsy is thus     required, which should provide non-invasive, highly penetrative, three-dimensional (3D)     imaging with sub-micron spatial resolution. Optical biopsy based on scanning two-photon     fluorescence microscopy (TPFM) is a good method for biopsy of skin due to its high lateral     resolution, low out-of-focus damage, and intrinsic three-dimensional (3D) section capability.     However current technology still presents several limitations including low penetration     depth, in-focus cell damages, and multi-photon phototoxicity due to high optical intensity in     the 800 nm wavelength region, and toxicity if exogenous fluorescence markers were required.     We study the harmonics optical biopsy of a human skin sample using a femtosecond     Cr:forsterite laser centered at 1230 nm. Higher harmonics generation is known to leave no     energy deposition to the interacted matters due to their energy-conservation characteristic.     This energy-conservation characteristic provides the “noninvasive” nature desirable for     clinical imaging. In our study, we will evaluate the clinical applications of optical skin     biopsy using harmonic generation microscopy.   "
176516|NCT00154934|"     Preeclampsia is a severe complication of human pregnancy. It occurs in 4-5% of all     pregnancies and remains a leading cause of maternal and neonatal mortality and morbidity. The     pathophysiology of this syndrome is not fully understood. Two theories are proposed to     explain the development of preeclampsia: defective trophoblast invasion in the first     trimester, and poor maternal immunoregulation against the fetus. Pro-inflammatory cytokines     are induced in the second mechanism, with a subsequent generalized endothelial dysfunction in     the mother. Interleukin-10 (IL-10) plays a major role in this pathway.      According to recent literature, debates still exist on the role of IL-10 in the pathogenesis     of preeclampsia. IL-10 may increase immunoregulation (seemingly against the development of     preeclampsia), but also prohibit the extravillous trophoblast invasion on the other hand     (seemingly towards the development of preeclampsia). According to recent authoritative     journals, the expression of IL-10 pre-eclamptic placenta is increased; but some other     influential journals have the totally contrary results. We believe this diverse exhibition     may be due to overlook the paracrine effect of decidual cells (representative of maternal     environment), and in vitro cultured condition does not parallel to physiological condition.      Our experiment has first obtained the qualification of Ethical Committee of our hospital and     the permission of the examined patients. We first collect the serum sample of preeclampsia     patient and analyze the IL-10 level by ELISA kit, and compared with normal control. Then we     isolate trophoblast from pre-eclamptic women and normal control. These trophoblasts are     further treated with (1) co-cultured with decidual cell line (2) Lipofectamine transfection     with IL-10 (overexpression of IL-10) (3) signal interference ribonucleotide (siRNA) of IL-10     (knockdown IL-10 function). Each groups (including trophoblast alone from patients or normal     control) were subjected to the analysis of IL-10 mRNA amount by RT-PCR. Further experiments     for these treated trophoblast are transwell migration assay and invasion assay, matrix     metalloproteinase assay to determine the change of invasive capacity; and Fas ligand     expression to determine the change of immunoregulation.      Our effort is not only to determine the role of IL-10 in the pathogenesis of preeclampsia,     but also the development of siRNA IL-10 may give a light in the treatment of preeclampsia.   "
176517|NCT00154947|"     With the current therapeutic focus in rheumatoid arthritis (RA) shifting from symptom control     to actual disease modification there is a growing demand for more objective and sensitive     ways to evaluate structural damage in the joints of these RA patients. Conventional     radiography of bone erosion and joint-space narrowing was the only imaging approach available     for this. Now significant advantages are offered in terms of speed, precision and scope over     conventional methods. These advances include digital radiography and computer aided analysis     as well as MRI which allow earlier identification of bone erosion and direct visualization of     pre-erosive changes, such as bone inflammation and synovitis. Molecular markers of tissue     turnover have been used for decades in clinical trials of osteoporosis, but only recently in     RA. In contrast to serum C-reactive protein (CRP), which is only a nonspecific indicator of     systemic inflammation and not directly reflective of structural damage to joints, more     recently developed molecular markers of synovial, cartilage and bone turnover might provide a     better indication of destructive activity of the disease. Compared with radiography and MRI     assessment, molecular markers are particularly useful for patient selection and treatment,     but can be used in a variety of ways to accelerate clinical trials and reduce the uncertainty     and cost of drug development. In this project, we will set up a panel of molecular markers     which could show an association with the MRI results and have a quantitative correlation with     the degree of joint damage (sensitivity: 90 – 95%; specificity: 80 – 90%). The work in this     project includes imaging markers evaluation and molecular markers analysis: X-ray scoring;     MRI; Bone degradation markers; Bone formation; Cartilage degradation; Cartilage synthesis;     Synovial turnover and Others. Nine molecular markers will be examined: CartiLaps     ELISA/CTX-II, Urinary CrossLaps ELISA/CTX-I, and Serum osteocalcin, Serum COMP, MMP-3, Serum     PINP, Serum PICP, Urinary PIIINP and Serum YKL-40. The data will be managed to evaluate the     significance of correlation to image and clinical reports, so as to get a simple algorithm of     parameters (molecular markers) which can reflect the structural damage of joint using     mathematics and computer science.   "
176518|NCT00154960|"     In this, here we want to present a new method for analysis variation in gene copy number for     patients and carriers of SMA. This is a relative quantitation method and, therefore, relies     on the inclusion of one or more internal control or reference sequences; quantitation of DNA     is relative to this reference sequence of known copy number. A peak height from within a     potentially duplicated or deleted target region is amplified simultaneously with a disomic     reference region in a multiplex PCR system.   "
176519|NCT00154973|"     Expression of hypoxia-inducible factor-α in oral precancers and cancers   "
176520|NCT00154986|"     An ovarian cancer cell line (OVTW-59) derived from an ovarian endometrioid carcinoma was     established and its sublines, labeled as P0, P1, P2, P3, and P4 with increasing invasion     abilities were selected from transwell invasion chambers.Using cDNA microarray and verified     with quantitative reverse-transcriptase polymerase chain reaction, we have identified IGFBP-3     as an invasion-suppressor gene. We plan to study the role of IGFBP-3 in ovarian cancer     invasion.   "
176521|NCT00154999|"     The oxygen tension increases more than 3 times from fetus to neonate. The oxidant stress     happens. And it will cause the destruction of RBC. So, we propose that the ROS may play an     important role of neonatal hyperbilirubinemia. There is strong association between the     bilirubin level and ROS levels at 3 days old in our pilot study.   "
176522|NCT00155012|"     1) Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the     relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical     management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of     coronary CT angiography and the influence of coronary calcium score on coronary CT     angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.   "
176523|NCT00155025|"     To investigate the prevalence of family history in prostate cancer patients in Taiwan and     evaluate the association of variation of diseases and family history   "
176524|NCT00155038|"     To evaluate if there is any imaging characteristic of breast cancers in women younger than 40     years of age.   "
176525|NCT00155051|"     Long term treatment of progestin has been demonstrated to have an inhibitory effect on     endometrial angiogenesis and the proliferation of endometrial stromal cells. As a result,     progestin is now widely employed in the treatment of endometrial cancer, endometrial     hyperplasia, and dysfunction uterine bleeding. In the treatment of adenomyosis, however, the     beneficial effect of progestin was limited. It might imply that the behavior of endometrial     cells in women with adenomyosis is different from that in women without adenomyosis.      Our previous study revealed that the expression of killer inhibitory receptors (KIRs) on NK     cells was decreased in eutopic endometrium in women with adenomyosis. It may be a     compensatory effect in which the NK cytotoxicity is activated in order to wipe out the     abnormal endometrial cells that might go out of the eutopic site of endometrium. It implies     that the formation of adenomyosis might be due to “abnormal” endometrial tissues, but not the     aberrant local immunological dysfunction in myometrium. This finding is compatible with     previous reports in which eutopic endometrium obtained from women with endometriosis or     adenomyosis was found to behave differently from endometrium in unaffected women.      In this study, we try to collect endometrial tissues from women with and without adenomyosis,     and then purify the endometrial stromal cells from endometrium. The endometrial stromal cells     are cultured for 8 days with the supplement of medroxyprogesterone (MPA) or danazol.     Quantification of IL-6 and IL-8 mRNA in endometrial cells, and the concentrations of IL-6 and     IL-8 in cultured media will be done with real time RT-PCR and ELISA respectively. The     expression of different cytokines of endometrial cells in response to progestin might be     further elucidated after our experiment.   "
176526|NCT00155064|"     The tissue kallikrein-kinin (KKS) and renin-angiotension-aldosterone system (RAAS) had been     implicated in regulating blood pressure and electrolyte homeostasis. Both of the KKS and RAAS     may work coordinately to regulate salt metabolism, local blood flow. Thus, we conducted this     study to elucidate, first, whether some alterations in components of the kallikrein-kinin     system could do effect on aldosterone secretion.      Previous study has shown the post captopril plasma aldosterone concentration (PAC)/ plasma     rennin activity (PRA) ration (ARR) was a reliable method for diagnosis of primary     aldosteronism (PA). The ARR change by angiotensin II receptor blockade was reported to be     significantly higher than that by ACE inhibitor. This study assessed whether angiotensin II     receptor blockade offers any additional advantage in the diagnosis of PA. Clinically we     evaluated the sensitivity and specificity of captopril (angiotensin-converting enzyme     inhibition) and losartan (angiotensin II type 1 receptor blocker) test in PA patient. This     interaction mechanism, in term, could further explain the interaction of KKS and RAAS.   "
176563|NCT00155558|"     To determine the maximum tolerated dose and dose limiting toxicity of 5-FU and leucovorin     with novel 48-hour infusion schedule, and to collect toxicity profile at different dose level     of 5-FU/LV 48-hour infusion.   "
176775|NCT00148850|"     The aim of this randomized study is to compare the effect of pioglitazone versus placebo on     change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at     least 6 months and with clinical lipoatrophy.   "
176527|NCT00155077|"     Carcinoma of the uterine cervix is a serious health problem. Cervical cancer is the most     common malignant neoplasm of women in Taiwan. There were 2,720 new cases of invasive     carcinoma of the cervix and 971 deaths from the disease in 2000. Cervical cancer is indeed is     an important disease in Taiwan.      The primary therapies for cervical cancer are surgery, radiotherapy or chemoradiotherapy.     Several clinical trials have showed that an improvement in time to progression and survival     for patients given chemoradiotherapy compared with radiotherapy alone. Chemoradiotherapy is     now regarded as standard modality to treat the locally advanced (stage IIB–IVA) or high-risk     early-stage cervical cancer. However, some of the cervical cancer patients still failed to     response to the treatment of cervical cancer or relapsed for completion of treatment.      Angiogenesis plays an important role in the pathogenesis of cancer. Recent studies have     related angiogenesis to cancer growth and metastasis Ultrasonography has been used in the     gynecologic field for decades. The previous studies of our team have shown that incremental     angiogenesis could be demonstrated in the tumorigenesis of ovarian, endometrial malignancies,     and cervical caner. Besides, other growth factors such as vascular endothelial growth factor     (VEGF), and IL-6 have also been reported to correlate with the angiogenesis and the prognosis     of cervical cancer. It seems that tumor angiogenesis could be utilized as a good marker to     survey the severity of disease and prognosis of early-staged cervical cancer patients.      There is no good method or marker which could be utilized to monitor the response of     radiotherapy and evaluate the prognosis of cervical cancer patients with advanced stages. So     we would like to propose this proposal to focus on the tumor angiogenesis in cervical cancer     patients with advanced stages. There are several purposes in this study. First, we will     evaluate the kinetic changes of tumor angiogenesis in cervical cancer patients who receive     radiotherapy or concurrent chemoradiotherapy. Second, we will evaluate that if the tumor     angiogenesis could be a marker to monitor the response of radiotherapy or chemoradiotherapy     in cervical cancer patients. The relation between tumor angiogenesis and radiotherapy will be     explored and clarified by this study. The comprehensive role of tumor angiogenesis in     cervical cancer will be elucidated by the results of this study.   "
176528|NCT00155090|"     Magnetic resonance spectroscopy (MRS) is a diagnostic technique in MRI that distinguishes     various metabolites on the basis of their slightly different chemical shifts or resonance     frequencies. The Proton is the most abundant nucleus in the body. We will try to establish     the typical proton MRS pattern of normal women breasts to be a guideline for future further     investigations.   "
176529|NCT00155103|"     The purpose of this study is to determine the effect of polymorphisms in the IL-1 gene     complex on the development of chronic hepatitis and hepatocellular carcinoma.   "
176530|NCT00155116|"     To evaluate the correlation between SERPIN D1 expression in clinical specimen (including     surgical specimen and blood sample) and lung cancer metastasis.   "
176531|NCT00155129|"     The release of the neuropeptide calcitonin gene-related peptide (CGRP) is thought to play a     causative role in migraine. Nociceptin immunoreactivity and ORL-1 mRNA have been detected in     human trigeminal ganglia where it was co-localized with CGRP. It may play a role in migraine     pathogenesis. We are collecting the blood samples of migraineurs for analysis of these     neuropeptides.   "
176532|NCT00155142|"     To address the following issues: (1) the course of small nerve fiber degeneration in type 2     diabetic patients, especially in asymptomatic patients; (2) the influence of blood sugar     control on development of the small fiber degeneration; (3) the correlation of skin     innervation with sensory thresholds, autonomic tests and parameters of nerve conduction     studies; and (4) the role of neurotrophins in diabetic neuropathy, we will perform skin     biopsy with quantification of IENF in type 2 diabetic patient without neurological symptoms.     The investigations all include clinical evaluation, electrophysiological studies,     quantitative sensory test and enzyme linked immunosorbent assay of neurotrophins. The     analysis of skin innervation with diabetic parameters will give important insights into the     mechanism, prevention and management of small fiber neuropathy in neurologically asymptomatic     type 2 diabetic patients, and also therapeutic strategies for diabetic neuropathy.   "
176533|NCT00155155|"     Taiwan is a hyperendemic area of hepatitis B virus (HBV) infection. Previous studies     demonstrated vigorous T cell responses to HBV-encoded antigens developed in patients with     self-limited acute hepatitis B. In contrast, weak or no T cell responses could be detected in     chronic hepatitis B (CH-B) patients. However, these immune responses are still not well known     in patients with acute exacerbation (AE) of CH-B and in patients with advanced liver     diseases, such as liver cirrhosis (LC) and hepatocellular carcinoma (HCC). The CD4+CD25+     regulatory T cells might suppress immune responses against foreign antigens and pathogens.     The roles of CD4+CD25+ regulatory T cells in patients chronically infected with HBV remain to     be clarified. The high percentage of HBV carriers in Taiwan are related to the vertical     transmissions. High maternal HBV viral load may make the newborns tolerant to the HBV.     However, the HBV-specific CD8+ T cells responses in the cord bloods of newborns are still     unknown. Thus, we want to resolve these issues in this study. We will enroll the HBsAg (+)     patients from NTUH. Blood samples will be collected. We will then analyze the HBV-specific     CD8+ T cell responses and the clarify the roles of regulatory T cells.   "
176534|NCT00155168|"     In this project, we will establish the efficient and accurate gene dose determination system     by combining the heterodulex analysis and gene dose analysis on DHPLC platform based on     various quantitative and multiplex PCR strategies and applying on detecting the carriers- in-     risk and patients with spinal muscular atrophy.This method is, therefore, based on the     observation that the amount of PCR product generated from each site of amplification is     proportional to the amount of starting template. Detection of PCR products is carried out on     DHPLC, which provide the sensitivity required for the detection of the single-copy dosage     changes.   "
176535|NCT00155181|"     EBV, infection process, immortalization, B lymphocytes, Epithelial cells, co-culture     Epstein-Barr virus (EBV) belongs to human γ-herpes viruses. Unlike other human herpes     viruses, EBV can only predominately infect two types of human cells: lymphoid cells and     epithelial cells and its infection is associated with several human malignancies of these two     cell types. The lymphoid cancers associated with EBV infection include Burkitt’s lymphoma,     Hodgkin’s disease, B lymphoma in immunodeficient patients and T/NK cell lymphoma. The     carcinomas associated with EBV are nasopharyngeal carcinoma and gastric carcinoma. One unique     biological feature of EBV is that it can infect and immortalize primary B lymphocytes in     vitro into lymphoblastoid cell lines (LCL). So far, limited information is known about the     whole EBV infection process and its regulation mechanism for immortalization. In this     project, three EBV infection models are setting up to reveal the cellular events and signal     transduction pathway possibly involved in EBV infection process and immortalization course of     action.   "
176536|NCT00155194|"     Null hypothesis of this study: Biliary atresia patients with cholestatic jaundice do not have     systemic immunity defect.   "
176598|NCT00156013|"     This research is being done to develop new treatment for non-hodgkin's lymphoma in subjects     whose cancer has returned or resisted treatment with chemotherapy. The investigational drug     clofarabine is being used in this study. An investigational drug is one that has not been     approved by the United States Food and Drug Administration (FDA).   "
176599|NCT00156026|"     This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month     follow-up with colposcopy and treatment if CIN 1 progresses.   "
176537|NCT00155207|"     This project entitled “A Study on Risk Mutations of the Vulnerability Genes of Schizophrenia”     (RIGOS) is a continuous effort following the well founded and arduous work of genetic study     on schizophrenia (SCH) by the Genomic Psychiatry Study Group (GENOP) of National Taiwan     University Hospital. So far the GENOP has established several important data banks, including     DNA bank and lymphoblastoid (EVB transformed) cell bank of 725 affected sib-pair SCH     families, 200 Trio SCH families, and 150 normal controls; and the clinical database of serial     follow-ups. An ongoing project, Positional Cloning Study on the Vulnerability Genes of SCH     (POCOS), carried out by the GENOP has found 11 candidate vulnerability genes with identified     expression in the brain. Besides, on the basis of two related projects, the Multiple     Psychopathological Study of SCH (MPSS) and the Etiological Study on SCH (SEFOS), the GENOP     has established endophotype indicators for schizophrenia in neuropsychological and     neurophysiological domains. The GENOP, a multidisciplinary research team, is thus ready to     search for risk mutations of the candidate vulnerability genes for schizophrenia in this new     proposal.      The basic strategy of this RIGOS Project is to search for risk mutations, based on     case-control design with sufficient statistical power, and then to validate these risk     mutations by convergent evidence of genetic epidemiological analyses, functional variation     studies using in vitro cell line experiments, microarray study, and neurophysiological study     (PPI) on mice model. Thus, this RIGOS Project has integrated 5 lines of experimental designs     to achieve 5 specific aims to identify and validate the risk mutations from 11 candidate     vulnerability genes found in the ongoing POCOS project based on Taiwanese Sample.      We are confident to be at the frontier work of searching for the risk mutations, with     functional validity, of SCH. The achievement of the RIGOS will be a mile stone to create new     era of genetic functional study to tackle pathophysiological mechanism of SCH and will be the     basis of developing novel diagnostic method and novel intervention method at the early stage     of SCH in the future.   "
176538|NCT00155220|"     There are 2 parts to this study.      First part:        -  Reliability of water displacement, circumference, tonometer.        -  Effect of taping: lifting effect measured with sonography        -  Effect of taping: peripheral circulation measured with DRT4      Second part:        -  Effects of different intervention models including decongestive lymphatic therapy (DLT)          and modified DLT   "
176539|NCT00155233|"     1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist        2. This study was designed to investigate the interaction between nalbuphine and morphine   "
176540|NCT00155246|"     To study whether pentoxifylline has additive renoprotective effect in patients taking ARB   "
176541|NCT00155259|"     The primary endpoint of this phase II trial is the objective response rate of the regimen.     The secondary endpoints include treatment-related toxicity, progression free survival and     overall survival and breast conserving rate.   "
176542|NCT00155272|"     This is a pilot study of concomitant radiotherapy and thalidomide for patients with locally     advanced HCC.Besides toxicity and efficacy, mechanistic studies including dynamic contrast     enhanced MRI and serum cytokines will be evaluated.   "
176543|NCT00155285|"     To test the ability of multi-detector spiral CT in evalting the infant complex congenital     heart disease.   "
176544|NCT00155311|"     To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone     samples will be collected from partially impacted third molars after orthodontic uprighting     for different period of time in volunteers. In situ hybridization and immunohistochemistry     analysis for OPG and RANKL will reveal their roles in this physiological process.   "
176545|NCT00155324|"     The aim of the study is to investigate the effect of extracorporeal shock wave therapy (ESWT)     on the thickness of plantar fascia measured by ultrasonographic examination among patients     with chronic plantar fascitis. The change of plantar fascia thickness will be correlated with     clinical improvement.   "
176546|NCT00155337|"     Photodynamic therapy for oral leukoplakia and erythroleukoplakia   "
176547|NCT00155350|"     In this study, we, the investigators at National Taiwan University Hospital, will evaluate     the efficacy of pharmacological therapy targeted to reduce insulin resistance (pioglitazone)     on the progression and compositional change of non-obstructive coronary atherosclerotic     plaques and coronary calcification by serial intravascular ultrasound     (IVUS)/multi-detector-row computed tomography (MDCT) follow-up in patients with type 2     diabetes or non-diabetic metabolic syndrome during a 2-year period.   "
176548|NCT00155363|"     Adiponectin, an adipose tissue derived protein, with anti-inflammatory properties that is     secreted from adipose tissue, is associated with insulin resistance. It has been shown to be     a predictor of cardiovascular events in both the general population and patients undergoing     hemodialysis. Adiponectin levels were inversely related to body mass index values, plasma     leptin levels, insulin levels, serum triglyceride levels, and homeostatic model assessment     index values. In addition to it’s ability in increasing insulin sensitivity, adiponectin was     demonstrated to have anti-inflammatory and anti-atherogenic properties. In patients with     ESRD, renal replacement method was either peritoneal dialysis or HD. High efficient dialysis     methods such as high flux HD and HDF had been used more and more popularly. High flux HD and     HDF have the advantages in middle to large molecule removal, and better hemodynamic     stability. Better clinical prognosis has been shown in patients undergoing high flux HD or     HDF. Although studies have demonstrated that the plasma adiponectin levels were elevated in     patients receiving HD, whether different dialysis modality will interfere the plasma     adiponectin levels and patients’ prognosis remain unknown. The current project is planned to     investigate the effects of different HD modality on the plasma adiponectin levels and its     correlation other serum inflammatory markers and vascular function. Patients’ long term     prognosis will also be assessed in the present study.   "
176549|NCT00155376|"     Morphine can induce constriction of sphincter of oddi and glucagon can facilitate bile     secretion and dilatation of bile duct. We conduct this randomized double blinded study to     evaluate the effect of enhancement in MRCP using intravenous morphine and glucagon.   "
176550|NCT00155389|"     Based on a universal eradication of H. pylori in an offshore island (Matsu) with a high     prevalence of gastric cancer as well as premalignant gastric lesion, we first examined the     infection rate of H. pylori. Secondly, we evaluated the efficacy of clarithromycin-based     triple therapy with a levofloxacin-based rescue treatment. And thirdly, we tested the     hypothesis that whether the cure of H. pylori can reverse the premalignant gastric lesion.     Fourth, we determine the cost-effectiveness of this intervention. The gene-environment     interaction will be addressed regarding gastric cancer carcinogenesis. Finally, the incident     rate of gastric cancer would be followed in this cohort.   "
176551|NCT00155402|"     This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular     surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation,     Gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery.   "
176809|NCT00156156|"     The objective of this study is to determine the long-term safety of asoprisnil in women with     abnormal uterine bleeding associated with uterine fibroids.   "
176552|NCT00155415|"     Colorectal cancer (CRC) is the leading cause of cancer death not only in the Western     countries but also in Taiwan. Colonoscopy is now gradually accepted as one of the powerful     tool for colorectal cancer screening. Not only for survey after positive fecal test, it is     also applied as primary screening modality for CRC screening.Colon cleansing before     colonoscopy thus becomes critically important and inadequate preparation may lead to low     diagnostic yield with missed lesions, increased risk of complication and prolonged procedure     time. Though the importance of good colon preparation can not be over-emphasized, diet     control before colonoscopy and ingestion of large amount of lavage solution remain a     significant hurdle to overcome and investigators continue to seek for the ideal colon     preparation with respect to quality and examinee satisfaction. After the introduction of     polyethylene glycol electrolyte lavage solution (PEG-ELS) for bowel preparation before colon     procedures, its safety was well documented and the efficacy of colon cleansing was proven     efficient. The timing of ingesting PEG-ELS is different between institutes and some ingest     PEG-ELS as a whole at the night before colonoscopic examination and some ingested in     split-dose manner which ingest half of the solution at previous night and remaining on the     day of examination. Some institutes ask examinee to receive lavage solution on the day of     examination. The manufacturer advices start taking medication on the day before the     investigation according to their printed instruction on the package of PEG-ELS. Though there     were a lot of studies that conducted to describe the result of colon cleansing in different     fashion, the result is still controversial. This prospective, randomized, single-blinded     trail evaluated and compared the efficacy of colon preparation at two timing of colon     preparation, namely, in previous night or on the day of colonoscopic examination. In this     study, we enrolled those who have already colon neoplasia detected during voluntary routine     health check-up and received second colonoscopic examination for either elective polypectomy     or endoscopic mucosectomy (EMR). We used not only the cleansing condition as a reference of     adequate preparation; we also compared the diagnostic yield of lesion number as an objective     comparator between these two methods.   "
176553|NCT00155428|"     Using biocardiac model in helping the total correction of the Tetralogy of Fallot.   "
176554|NCT00155441|"     Sleep disturbance is prevalent in chronic dialysis patients and there is a negative     correlation between the quality of life and overall survival and sleep disturbance in them.     Cognitive-behavioral therapy is an effective behavioral therapy for insomnia clinically. In     previous studies, cognitive-behavioral therapy can redress anxiety in chronic hemodialysis     patients. This study tries to elucidate its therapeutic effect on the sleep disturbance in     chronic peritoneal dialysis patients.   "
176555|NCT00155454|"     Recurrent vitreous hemorrhage after vitrectomy for complications of diabetic retinopathy is a     common occurrence. The hemorrhage may appear within the first few weeks after surgery or     months later. This complication may delay visual rehabilitation significantly and sometimes     requires additional procedures or surgery, jeopardizing previous successful operation. The     causes of bleeding are diverse. While evidence suggests fibrovascular proliferation from the     sclerotomy sites or in the vitreous base may be an important source of recurrent vitreous     hemorrhage, other origins of hemorrhage exist including lysed clot from residual vitreous     skirt, injured retinal vessels from surgery, and incompletely removed fibrovascular tissues.     The latter three conditions may be the major sources of early postoperative vitreous     hemorrhage. We have shown that peripheral retinal cryotherapy along with cryo treatment at     the sclerotomy sites may effectively reduce the incidence of fibrovascular proliferation at     the inner surface of sclerotomy sites and prevent the late-onset recurrent vitreous     hemorrhage. However, many patients still experience disturbing vitreous hemorrhage within the     first two to three weeks after post-operative transient clear-up of the vitreous. We     hypothesize that gas bubble within the vitreous cavity may mechanically temponade the fragile     retinal vessels, and concentrate the coagulation factors in the vitreous cavity, allowing the     integrity of vessel walls gradually recovers and thus preventing the occurrence of early     postoperative recurrent vitreous hemorrhage.      To test this hypothesis, a clinical study was undertaken to investigate the effect of     long-acting gas infused into the vitreous cavity at the end of diabetic vitrectomy in the     prevention of recurrent vitreous hemorrhage.   "
176556|NCT00155467|"     Setup CT images database of congenital heart disease.   "
176557|NCT00155480|"     This study will be using finite element meshes and averaged algorithms to create the     numerical thoracic aorta at different ages.   "
176558|NCT00155493|"     Periorbital rejuvenation has been an issue of great interest in plastic surgery. Adipose     tissue plays an important role in the periorbital anatomy, and has a great impact on the     aging process of the region. We believe age-related atrophy of the facial adipose tissue may     be related to the decreased proliferation and differentiation capability of the preadipocytes     (adipose precursor cells).   "
176559|NCT00155506|"     Schizophrenia is a chronic and devastating major psychiatric disorder. Family, twin, and     adoption studies indicated that schizophrenia has a significant genetic component. The mode     of transmission is still not clear and a multilocus model was proposed. The location of     susceptibility gene of schizophrenia is still under active search using molecular genetic     methods.      We propose to collect genomic DNA and lymphoblast cell lines of a total of 150 DSM-IV     schizophrenic patients and their first degree relatives including parents (parent-offspring     trios) and non-affected siblings in three years. Adequate statistical power of molecular     genetic studies is a great concern. For this concern, we will examine the patients and their     parents clinically by using the Diagnostic Interview for Genetic Studies (DIGS) for     diagnostic assessment, and by using neuropsychological battery including sustain attention,     executive function, verbal memory and general intelligence for neuropsychological     evaluations.      The project is feasible because (1) The PI and his research team have experience in     successfully collecting co-affected sib-pair families of schizophrenia and in setting-up     molecular genetic laboratory in the past decade. We are experienced and competent to execute     this project. (2) The PI and his research team have established the instruments using to     clarify the phenotypes including the DIGS, the neuropsychological battery these years.      Major goals of this project are: (1) to cooperate with this important Taiwan Genotype     Consortium proposed by the NHRI; (2) to detect major schizophrenia susceptibility genes     related to the neuropsychological endophenotype; (3) to do further fine mapping on suggestive     linkage markers to replicate previous linkage studies results using our previously-collected     co-affected sib-pair family sample; and (4) to deposit the lymphoblast cell lines into NHRI     Cell Bank serving as a national resource for basic research in Taiwan.   "
176560|NCT00155519|"     Current diagnostic criteria of schizophrenia are based on marked positive and negative     symptoms. This definition may impede the exploration of basic phenomenological     psychopathology or pathological mechanism of schizophrenia. Schizophrenia was found to have     neuroanatomical, neurophysiological and neuropsychological impairment. However, the existence     of these basic pathological states may not manifest as clinical state of schizophrenia, and     it is found in normal relatives of schizophrenia proband. The clinical state of this     underlying pathology may include so-called latent or early, or pseudo-neurotic schizophrenia     or schizotypal disorder. The manifestation of prominent neurotic symptom state may not only     present as an psychopathological issue, but also induce misdiagnosis in clinical practice.     This may interfere early diagnosis of schizophrenia and may delay the chance of early and     appropriate treatment.      Taking the fact of this disadvantaged conditions, this research is for exploration of     clinical pathology and neuropsychological functions of latent or pseudo-neurotic     schizophrenia. The strategy ia a natural follow-up study on the clinical cases obtained from     the registration record of the medical charts of the National Taiwan University Hospital from     1970 to 1995. The natural follow-up results till study time (5 yrs to 30 yrs following     period) will be explored. By using neurotic group (50 cases), latent schizophrenia group (50     cases) and schizotypal group (30 cases), the differences in clinical pathology,     neuropsychological functions and family history of schizophrenia will be examined. There are     5 hypotheses to be tested: (1) Schizotaxia may exist as the manifestations of latent     schizophrenia, schizotypal disorder and frank schizophrenia. The severity of pathology     increased step by step; (2) The syndrome may change from the lower order to higher order to     higher order, but not all of them changed to the higher order; (3) The clinical pathology of     latent schizophrenia has both neurotic symptom as well as basic symptoms of schizophrenia;     (4) There is the same kind of neuropsychological impairment of schizophrenia in the group of     latent schizophrenia, and (5) The prevalence of schizophrenia in the first degree relatives     of latent schizophrenia is higher than that of the general population. Finally, this study     results will help the establishment of valid screening and/or diagnostic method (criteria) of     latent schizophrenia for clinical and research usage.   "
176564|NCT00155571|"     Periodontal disease is considered to be an infection disease. Recent evidence supported the     role of smoking as a potent risk factor for the development of periodontal disease. However,     the effect of another oral habit, betel quid chewing on periodontal tissues has not been well     determined. The purpose of the present study is to analysis the role of bacteria on the     periodontium in the betel quid chewers. Plaque samples will be collected from betel quid     chewers and the occurrence of periodotopathogens will be analyzed Since most chewers also     smokers, plaque samples from age matched smokers but not betel chewers and non-smokers will     analysis for comparison. An in vitro test is also performed to evaluate whether the extract     has a direct inhibitory effect on common periodontal pathogens, such as Porphyromoans     gingivalis, Bacteroides forsythus, Actinobacillus actinomycetemcomitans.   "
176565|NCT00155584|"     Photodynamic therapy (PDT) has been developed as a promising new cancer treatment modality,     which involves the uptakes of a photosensitizer by tumor cells, followed by the activation of     photosensitizer with approximate wavelength of light. The mechanisms of the PDT-induced     cytotoxic effect relate to singlet oxygen and other reactive oxygen intermediates generated     by PDT, which give rise to cellular stress and cause cell death. Previously, using the     homemade LED light source, we have shown that ALA-PDT is effective for the treatment of     premalignant lesions such as mucosal dysplasia and carcinoma in situ of oral cavity. Due to     the advantages of low cost, high reliability, and portability, LED light source provides an     alternative approach for the light irradiation of PDT.      Verruca vulgaris are benign skin papillomas caused by the human papilloma virus (HPV). They     are very common and can affect many different sites including the face, hands, feet and     genitalia. Although the present therapeutic approaches are more or less effective in     eradicating the lesions, relapses are very common. Furthermore, at times the anatomical     location and depth of lesions often make the treatment difficult, time-consuming and painful.     Therefore, it is necessary to develop new modalities for wart treatment.      The purpose of this clinical trial is to develop topical ALA-PDT as an alternative treatment     of wart but without the unwanted side effects of pain and burning. To fulfill this goal, the     following works will be performed. First, topical ALA formulation and LED array will be     specifically designed and developed for the skin lesions. Second, the efficacy of the ALA     formulation designed for wart treatment will be evaluated with in vivo fluorescence imaging     system. Third, the therapeutic efficacy of ALA-PDT will be evaluated by using a LED array     designed for skin irradiation. Forth, the unwanted side effects of pain and burning will be     further compared between red and green LED array.   "
176566|NCT00155597|"     The aims of this study are:        1. To develop a disease-specific questionnaire for hip fractures.        2. To find the influences of physical therapy (PT) on patients' function and health-related          quality of life (HRQL).        3. To estimate the quality adjusted life years (QALY) of cases of hip fracture with or          without the PT program by a quality-adjusted survival (QAS) method.        4. To perform cost effectiveness analysis (CEA) to evaluate the effectiveness of PT and as          a base to compare it with other health intervention programs.      At the beginning of the study, the investigators will develop the disease-specific     questionnaire for hip fractures. Cases of patients with hip fractures hospitalized in     orthopedic wards of the National Taiwan University Hospital (NTUH) and Chung-Hsing Hospital     of Taipei from August 1, 1989 to July 31, 1999 are the study population during the first year     of this study. According to their receiving PT or not during hospitalization, the patients     are assigned to a PT or non-PT group. The identification (ID) numbers will be matched with     the death certificate file of the Department of Health to verify the survival status.     Furthermore, 30 cases per group per year will be randomly sampled to interview their HRQL and     evaluate their function with the disease-specific questionnaire for hip fractures. Combining     the survival function and HRQL, the QALY could be estimated. Cases of hip fracture admitted     to the orthopedic ward of NTUH and receiving a PT program from January 1, 2000 will be the     second-year study population in this study. They will be randomly assigned to a group of     follow-up PT (group I) or non-follow-up PT (group II). The patients assigned to group I will     have a 4-time PT evaluation and treatment at home after discharge from the hospital (1 week,     1 month, 3 months and 6 months after discharge). All patients will be evaluated at discharge,     1 month, 6 months, and 1 year after discharge to follow their survival status, functional     status and HRQL. The expected results of this study will be to develop the disease-specific     questionnaire for hip fractures, to show the functional outcomes of cases of hip fracture,     and to estimate the QALY of them.   "
176567|NCT00155610|"     The investigators will recruit a cross-sectional group of diabetic women in internist     clinics. UDS will be applied for voiding function in each case. Intravesical electrical     stimulation will be used to test CPT per 5 Hz, 250 Hz, 2000 Hz for the patients. The     differences of intravesical CPT between diabetic women with and without voiding dysfunction     will be determined.   "
176568|NCT00155623|"     The aims of this prospective study are: (1) to prospectively investigate the true     prevalence rate, the acquisition and spontaneous clearance of H. pylori infection year by     year in the population whose ages between seven and fifteen. (2) to explore the risk factors     of transmission of H. pylori infection in Taiwan. (This information may be use as the guide     for conduction of the national policy of public health and disease prevention.)   "
176569|NCT00155636|"     This PPG entitled “A Study on Etiological Factors of Schizophrenia” (SEFOS) focuses on     searching for the separate etiological factors under the understanding that schizophrenia is     a complex disorder. Multifactorial model has been most often proposed as the etiological     model. Up to now, fragmented knowledge of etiological factors, including genetic factor and     environmental insults were reported in literature, and a two-strike hypothesis has been     proposed. This PPG of SEFOS formulates a dynamic etiological hypothesis of schizophrenia.     Specific, however heterogeneous, genes are hypothesized to be located in chromosome 1q, 6P,     8P, 15q, and 22q; specific environmental insults or stress are hypothesized to be acting in     the vulnerable brain a long different stages of biological and/or psychological development.     The interaction of specific genes and specific environment insults/stress along different     stages of development will result in specific neurobiological abnormalities as shown in     neuropsychological, neurophysiological and neurochemical/neuroimaging abnormalities. For this     hypothesis testing, this PPG of SEFOS designs 3 projects of: (1) A Study on Neurobiology of     Schizophrenia; (2) A Study on Environmental insults/stress of schizophrenia; and (3)     Molecular Genetics Study of Schizophrenia. Project No.1 aims at finding different levels of     neurobiological and anatomical abnormalities; Project No.2 aims at finding different levels     of environmental insults/ stress; Project No.3 aims at locating vulnerability genes in     different chromosome regions. A core unit for administrative integration, for case/family     recruitment and statistical analysis is also designed. The dynamic etiological complex will     be explored under multivariate statistical analysis. This PPG of SEFOS adopts     multidisciplinary approach including clinical psychiatrists, psychopathologists,     neuropsychologist, neurophysiologist, neuroimaging (magnetic resonance imaging) specialist,     genetic epidemiologist, molecular genetic specialist, genetic statistician, and     biostatisticians. This team has sound mutual trust base on the experience of being working     together and attending regular research meeting for the part several years under the     leadership of the principal investigator of this PPG.   "
176570|NCT00155649|"     This Group of Genomic Research in Psychiatric Disorders (GENOP) located at the Department of     Psychiatry, College of Medicine and National Taiwan University Hospital (NTUH) had completed     a serial psychopathological study of schizophrenia (SCH) defined by DSM-IV criteria. The     results of this GENOP included: (1) delineating 2 to 3 subtypes of schizophrenia with     prospective follow-up validity; (2) finding a trait marker of impaired attention measured by     continuous performance test (CPT); (3) impaired executive function assess by Wisconsin Card     Sorting Test (WCST) and impaired inhibition of P50 evoked potential; (4) five dinucleotide     repeat polymorphism (DRP) markers in 5 different chromosomes with significant linkage scores,     including D1S251 at 1q42.1, D6S296 at 6p22 , D8S1222 at 8p14, and D15S976 at 15q14, and     D22S278 at 22q12; (5) finding a significant linkage of polymorphism marker located in a     neurodevelopmental gene NOTCH4 ( 6p22); and neurophysiological function related gene CHNRA7     (15q14); (6) successfully collected 700 multiplex families, collected by the collaboration     between of NTUH, Taiwan – NIMH, USA in the Taiwan Schizophrenia Genetic Linkage Study (TSLS)     project, with at least two siblings affected with schizophrenia in Taiwan. A genome-wide scan     on this big sample will be completed recently in the laboratory of NIMH, U.S.A.. Around 300     families had also CPT data in the whole family. This is probably the biggest number of     multiplex families of a single ethnicity all over the world; (7) successfully setting up DNA     and cell banks as well as clinical data bank. This substantial long track of this GENOP     provided convincing background for this Positional Cloning Study on Schizophrenia (POCOS).      Understanding the controversial results of current linkage study on SCH world-wide, this     POCOS was designed to make a break through design in the study for locating and identifying     the vulnerability genes of SCH by using (1) phenomenological subtypes; (2) endophenotype     defined by impaired attention (CPT) and/or impaired executive function (WCST); (3) using     large enough size of samples of a single ethnicity of Taiwanese family pedigrees.      Major research tasks include (1) Linkage analysis and quantitative trait loci analysis, in     collaboration with the team of Harvard Medical School, on the endophenotype defined by     impaired attention and impaired executive function in 300 families with at least two siblings     affected with SCH; (2) Two stages of genotyping, using High Throughput technology, of dense     SNP markers, around DRP markers with significant linkage scores in the NTUH and TSLS studies,     with average marker interval of 30kb in 3000 subjects of 700 multiplex families (a total of     300 markers) for linkage and quantitative trait loci analysis; (3) Two stages of study on the     polymorphisms and/or mutations of candidate genes using association study and TDT test. Each     stage with 10 Candidate Genes in the NTUH and TSLS project, respectively. In the first stage,     these are: (a) Neurodevelopmental related genes: DISC1, TRAX (1q42.1), NOTCH4 and TNF(6p21.3)     and NT-3; (b) Neurotransmitter receptor genes of CHNRA7 (15q14) and NMDA related to attention     impairment; (c) Neurotransmitter metabolizing enzyme gene COMT (22q11.2) related to impaired     frontal lobe function; and (d) Pharmacology related genes of DRD3 and 5HTA2.   "
176571|NCT00155662|"     Occupational injury results in family economic crisis and national productivity loss; it is     really becoming an important issue in Taiwanese society. Low back pain is the most frequent     injury affecting workers. In addition to the prevention of injury, having a work-hardening     program and getting the injured workers returned to work are also challenges for medical     personnel. The purposes of this study are:        1. to develop a guideline to assess the low back pain workers' impairment and working          capacity;        2. to formulate a feasible work-hardening program for the low back pain workers; and        3. to execute the program, evaluate the training effect and then follow up the rate of          return to work of the low back pain workers.      In the first year, a guideline for assessment of low back impairment and working capacity     will be developed. It may consist of the demographic data, the working status, the physical     need in work, trunk muscle isokinetic strength, Oswestry low back disability questionnaire,     functional capacity evaluation and quality of life questionnaire. The whole assessment     package will be empirically applied in low back pain workers and the validity and reliability     will be tested. A work-hardening program for low back pain workers will be established in the     first year through meetings with experts and literature review. The work-hardening program     will consist of training of trunk muscle strength, flexibility, and general fitness. A     sling-exercise training model will be applied in the program. In the second year, low back     pain workers in outpatient departments will be recruited with their own agreement and grouped     randomly into either the work-hardening group or the control group. The expected number of     subjects is 30 in each group. According to the result of impairment assessment and work     capacity, the workers in the work-hardening group will start the individualized     work-hardening program for 3 months. After the program, the workers will be assessed again to     evaluate the training's effect, and the investigators will follow the rate of return to work     among them 3 and 6 months after the program. The workers in the control group will be     followed for 6 and 9 months after enrollment to collect the rate of return to work in this     group.   "
176572|NCT00155675|"     The Study to evaluate the clinical effect of Gusuibu lasts for 3 years. It aims to evaluate     its effect on bone density of postmenopausal osteoporosis. Besides, its effects on the liver,     kidney and the hematological influence will be evaluated, too.   "
176573|NCT00155688|"     We propose to study 900 sib-pairs with the disorder. Our Specific Aims are: 1) To clinical     assess a pedigree sample having adequate power to detect genes for schizophrenia. 2) To     conduct a genome scan to find such loci. 3) To transmit all data to the NIMH designated cell     repository and data management centers. We will attain these goals by achieving the     following: 1) From Taiwan and China, we will collect 900 Han Chinese sib-pairs having DSM-IV     schizophrenia. 2) We will examine all family members using the Diagnostic Interview for     Genetic Study and the Family Interviews for Genetic Study. The PI participated in the     development and field testing of these interviews and has an already established training     program for their use. They have been translated into Mandarin by the Taiwanese     investigators, who have used them in prior studies. 3) Blood samples will be sent to the NIMH     designated cell repository for creation of lymphoblastoid cell lines. 4) Clinical Data will     be entered using the database software created for the NIMH Human Genetics Initiative. Data     will be vetted and sent to the NIMH designated data management center. 5) We will complete a     genome scan using 450 markers spaced at an average of 10 cM intervals using markers that have     been optimized for use in the Han Chinese population. The scan will be completed with no cost     to the NIMH through an agreement with Millennim Pharmaceuticals, a biotechnogy company in the     the Boston area that the PI has worked with on a prior genetic linkage study of     schizophrenia. All genetic analyses will be approved by our consultant, Eric Lander, PhD. 6)     All clinical data will be made available to the scientific community by the end of the     funding period. All genotypes wil be available one year after they are created but no later     than a year after the funding period. This project as feasible because 1) The PI has already     coordinated one multi-site genetic linkage study of schizophrenia and has participated in a     second. 2) We have a long-standing relationship with our Taiwanese collaborators and an     effective, albeit, more recent working relationship with our Chinese collaborators. 3) We     have conservatively estimated that each site has access to more than enough available     families having two schizophrenic siblings. 4) The PI's Harvard team has had prior experience     collaborating on genotyping and linkage analysis projects with Millennium Pharmaceuticals.     This, and Millennium's prior genotyping experience shows that the genotyping phase of the     work is feasible.   "
176574|NCT00155701|"     Several chromosomal loci obtained from genetic linkage studies have been reported of relating     to schizophrenia. These areas include of 1q32-41, 6p24-21, 8p22-21, 15q13-14, and 22q11-12.     The names of these genes located in these loci have not been identified, nor have the     function and the relationship to the disease. Our research team using genetic linkage studies     has found a strong linkage (NPL Z score = 2.18, p=0.01) between the D1S251 marker and     schizophrenia disease. This marker is about 4 kb away from DISC1 (disrupted in schizophrenia     gene 1) gene. In a Scottish family, a balanced translocation [t(1;11) (q42.1;q14.3)] has     cosegregated inside the schizophrenia affected members of the family (LOD score =6.0). The     breakpoint of the translocation is located at the intron area between exon 8 and exon 9 of     DISC1 gene. This translocation disrupted the gene and caused its malfunction. A large     molecular genetic study study recently in Finland has also demonstrated strong linkage     evidence (Zmax=3.21) between the DIS2709 marker, located among exon 4 and exon 5 of DISC1     gene, and schizophrenia in a. All these findings have indicated that DISC1 gene is a     potential positional candidate gene and worth for further study.      The main purposes of this proposal include: (1) To evaluate the incidence rate of the     balanced translocation between the chromosome 1q42.1 and 11q14.3 in approximately 500     schizophrenic patients in Taiwan. Furthermore, we will compare the clinical symptoms, illness     course, and family genetic model to examine if any particular characters coexist with the     translocation. (2) To search for the genetic polymorphisms in DISC1 gene area, where the     thirteen exons, the promoter regions (1 kb upstream the start codon), and the breakpoint area     (1 kb of both upstream and downstream area) will be analyzed by the method of denaturing high     performance liquid chromatography (DHPLC). Case-control association study will be performed     further in each 200 schizophrenic patients and normal controls to evaluate the relationship     between the disease and the clinical characteristics.      This proposal is quite feasible and prospective with the following reasons. (1) All the DNA     samples and the clinical data have been collected and evaluated completely for further     analysis. (2) Our research team has built up an integrated andreliable molecular genetic     laboratory. All the facilities necessary for this study (DHPLC) had been setup with standard     operating protocols and working routinely. (3) DISC1 gene has strong linkage evidence with     schizophrenia in Taiwanese sample. The high prior probability of DISC1 gene as a positional     candidate gene increases the successfulness of association study. . (4) Once the relationship     among balance translocation, genetic polymorphism and the schizophrenia have established,     further functional study will be evaluated to understand the possible mechanisms involved in     the disease.   "
176575|NCT00155714|"     The aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors     (sildenafil) in primary and secondary pulmonary hypertension   "
176576|NCT00155727|"     The laparoscopic colectomy has been enthusiastically used by many colorectal surgeons in     Taiwan, Japan, Europe, and USA, for around 10 years. Further clarification of the     controversies cited above will be based on the evidence-based medicine, i.e., the randomized,     well-controlled, prospective clinical trials. Actually, a handful of randomized prospective     data regarding the laparoscopic colectomy has been appeared in USA and Europe. However, we     still do not have this kind of data in Taiwan, and therefore this study is important and     mandatory.      In this project, we assumed that a difference in cancer-related survival of less then 15%     between treatments indicates an equivalent efficacy. Assuming a 70% 5-year, cancer-related     survival of stage II and III colorectal cancer patients in the open colectomy group, a     minimum of 100 patients per group was required to showed that both surgical techniques were     equivalent with an α-level of 0.20 and a β error of 0.05. Only patients with stage II and III     disease undergoing curative resection will be enrolled onto this study. The patients will be     randomly allocated to either treatment group by block randomization method. Postoperatively,     the patients will be prospectively evaluated regarding the following parameters including     operative stress, such as erythrocyte sedimentation rate, serum interleukin-6, WBC counts and     classification, CD-4 to CD-8 ratio, postoperative life quality, such as wound size, degree of     pain, time to have flatus passage and feeding, time to resume daily activity and work, and     the oncological outcomes, such as recurrence patterns of tumor, and 5-year patient survival.     The evaluation of above-mentioned parameters will be single-blindly done by our research     assistant, who has no idea of both surgical techniques. We hope this study will promote the     level of surgical research in Taiwan.   "
176577|NCT00155740|"     Ovarian cancer became a more and more important disease in recent years due to its first     mortality rate of gynecologic malignancies. The incidence of ovarian cancer also increased in     recent year in Taiwan. The lack of symptoms, difficulties in early diagnosis, insufficient     accurate tumor markers, and lack of information about ovarian tumor biology contribute to the     poor prognosis in ovarian cancer patients. The prognostic parameters for ovarian carcinomas     are tumor stage, histologic subtype, degree of malignancy, and residual tumor after surgical     treatment. However, these factors present an incomplete picture of the tumor biology of     ovarian cancer and are frequently interrelated. Thus, the identification of new biologic     factors predictive of individual disease course and prognosis would be extremely useful.      Detection of tumor markers that are released into the circulation can aid in the diagnosis     and/or monitoring of therapeutic responses of patients with various tumors, including     carcinomas of ovary. CA125 is the most commonly used serum marker for patients with ovarian     carcinoma. Although it has proven clinically valuable in monitoring the response of patients     to therapy, some ovarian carcinomas do not express CA125, and CA125 often is increased in     patients with inflammatory disease. Thus, there is a need for improvement, either in the form     of a more specific and/or sensitive assay or an assay that uses a different marker and can be     used to complement CA125 toward the goal to improve patient survival by improving diagnosis.      Mesothelin is a 40-kDa glycosylphosphatidylinositol-linked glycoprotein. In normal tissues,     the expression of mesothelin has subsequently been shown to be largely restricted to     mesothelial cells, although immunoreactivity has also been reported in epithelial cells of     the trachea, tonsil, fallopian tube, and kidney. Mesothelin has been shown to be     over-expressed in pancreatic carcinomas, gastric carcinoma and ovarian carcinoma, and it     seems that mesothelin may be utilized as a new tumor marker for ovarian carcinoma. We will     evaluate that if mesothelin can be a new potential tumor marker for ovarian cancer in this     proposal.   "
176578|NCT00155753|"     The purpose of this study is to evaluate the possible candidate gene of pathological myopia   "
176600|NCT00156039|"     The purpose of this study is to determine whether family physician 'routine follow-up care'     of women with breast cancer in remission is an acceptable alternative to the existing system     of specialist follow-up. Primary outcome measure are event rates of oncological catastrophes     and quality of life.   "
176601|NCT00156052|"     To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions     over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25     fractions over 35 days) in women with node negative breast cancer who have undergone     lumpectomy.      The primary outcome is local breast recurrence and secondary outcomes include morbidity and     cost effectiveness.   "
176936|NCT00158262|"     This study will assess the effectiveness of taking propranolol soon after a traumatizing     incident in reducing the incidence and severity of posttraumatic stress disorder in acutely     traumatized individuals.   "
176579|NCT00155766|"     Chemotherapy is the current standard treatment for unresectable recurrent cervical carcinoma     after radiotherapy or distant metastasis of cervical carcinoma. The most effective regimens     are cisplatin-based chemotherapy. After failure of the cisplatin-based chemotherapy, there is     still no treatment that has been proved to be effective.      Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer     especially those high-risk types (HPV 16,18,31,45) have been strongly associated with     cervical cancer. HPV 16 was found in more than 50% of cervical cancer tissues. Results from     many animal tumor models have indicated that immunization with tumor antigen-pulsed dendritic     cells can trigger a long-lasting anti-tumor immune response and significantly inhibit the     growth of implanted tumor cells. Recently, many clinical trials have been conducted to     evaluate the feasibility and safety of immunizing cancer patients with tumor antigen-pulsed     dendritic cells. No severe toxicity has been reported and some patients were shown to respond     to the treatment. Based on previous animal and clinical studies by other investigators, we     propose to evaluate the potential of immunizing cancer patients with antigen-pulsed     autologous dendritic cells as a cancer vaccine to treat for recurrent cervical cancers after     failure of cisplatin-based chemotherapy treatment or refusing chemotherapy. In this study, we     will generate dendritic cells by culturing patient's autologous PBMC with GM-CSF and IL-4 in     vitro. These dendritic cells will be pulsed with synthetic peptides representing the CTL     epitopes on HPV Type 16 E7. Antigen-pulsed dendritic cells will be injected into inguinal     lymph nodes under the guidance of real-time sonography. Each patient will receive four     injections and 12 patients in total will be recruited for this study.   "
176580|NCT00155779|"     The acute respiratory distress syndrome (ARDS) is an important cause of acute respiratory     failure with a high mortality rate. The mechanism of resolution of the late organizing phase     remains uncertain. The ACE gene contains a polymorphism based on the presence (insertion, I)     or absence (deletion, D) within an intron of a 287-bp nonsense DNA domain, resulting in three     genotypes (DD and II homozygotes, and ID heterozygotes). It has been shown that I/D     polymorphism of ACE gene may account for half the variance of serum ACE levels in the     Caucasians. Polymorphism of the ACE gene has also been shown to contribute to the development     of some respiratory diseases. We hypothesize that the presence of ACE gene polymorphism can     affect the outcome of ARDS. The objective of this proposed study is to determine the     genotypes of ACE gene polymorphism and assess the influence of ACE genotype on the outcome     and pulmonary resolution of patients with ARDS. Patients diagnosed to have ARDS are eligible     for possible inclusion into the study. The ACE genotype of all patients with ARDS will be     determined by polymerase chain reaction (PCR) amplification of the respective fragment for     the D and I alleles from intron 16 of the ACE gene and size fractionation by electrophoresis.     The outcome of patients with ARDS in the three genotypes will be compared.   "
176581|NCT00155792|"     Cervical cancer the most frequent neoplasm and the third mortality rate of malignancies of     the women in the world. It results in about 200,000 women dying of cervical cancer each year     worldwide. The available forms of treatment-surgery, radiation therapy, and chemotherapy are     all cytoreductive treatment modalities, so in addition to killing cancerous cells, healthy     cells are also destroyed in the process. Indeed, there is a need to decrease the incidence of     cervical cancer and develop better forms of its treatment.      Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer     especially those high-risk types (HPV 16,18,31,45) have been strongly associated with     cervical cancer. HPV 16 was found in more than 50% of cervical cancer tissues. So the host     immune response plays an important role in determining the regression of cervical abnormality     or persistence and progression to malignancy via targeting HPV.      The ideal cancer treatment should be able to eradicate systemic tumors at multiple sites in     the body while having the specificity to discriminate between neoplastic and nonneoplastic     cells. In this regard, antigen-specific cancer immunotherapy represent an attractive approach     for cancer treatment. It is now clear that major histocompatibility complex (MHC) class I     restricted CD8+ T cytotoxic cells are critical to the generation of antitumor immunity.     Cell-mediated responses are critical in anti-tumor immunity.      By cooperating with Dr. TC Wu in Johns Hopkins Medical Institutes, we have recently developed     some E7-specific cancer vaccines of different strategies such as DNA, or     replication-defective SINrep5 virus. We found that these E7-chimeric DNA vaccines are capable     of preventing and treating the growth of murine model tumors expressing E7. These positive     results from the preclinical murine models have encouraged us to focus on the development of     cancer vaccine and immunotherapy and apply these vaccines to human subjects. However, it is     very important to set up various E7-specific immunologic assays of human being to evaluate     the effect of cancer vaccine or immunotherapy in the future clinical trials. So we would like     to provide this proposal to address on the development of HPV 16 E7-specific immunologic     assays in human being.   "
176582|NCT00155805|"     By using combination of the expression of COX-2 and NOS and immunologic reaction in the     esophagus with manometry of LES and cruel diaphragm and 24 hr esophageal pH monitoring to     investigate the mechanisms and to make a new and more clinically applicable clarification of     these reflux diseases will be valuable in the clinical management and prevention. We will     perform the following works and complete the objectives: 1) comparing the difference of     immuno-inflammatory reactions among NERD, reflux esophagitis and Barrett’s esophagus; 2) the     different expression of PGs & COX-2 in functional heartburn, hiatus hernia, NERD, reflux     disease and Barrett’s esophagus; determining the subtype of EP receptor (EP1~4); 3)     determining and comparing the expression of NOS in the esophagus; 4) investigating the role     of ROS in the esophagus; 5) in correlating cytokine, COX-2 and NOS with LESP, TLESR,     diaphragm EMG and 24-hour esophageal pH ; 6) the difference of expression of cytokine,     atrophic gastritis and Hp in gastric mucosa, in correlating with intragastric acid status,     among functional heartburn, hiatus hernia, NERD, erosive esophagitis and Barrett’s esophagus;     to determine whether should eradicate Hp in reflux esophageal disease; 7) the effects of     lipid peroxidation related immunologic reaction, with relation to COX-2 and NOS, in the     inflammatory activity and esophageal carcinogenesis of esophagus; 8) the effects of     cytokines, COX-2 and NOS on the apoptosis in these reflux esophageal diseases; 9) integrating     immuno-inflamatory reaction, COX-2, NOS with manometry of LES and diaphragm, and 24-hour pH     monitoring and intragastric pH to newly clarify GERD into evidence based categories.   "
176610|NCT00146315|"     In Spain, family physician are currently recommended to prescribe an unsupervised walking     program to their coronary heart disease (CHD) patients as a part of their cardiac     rehabilitation program. However, there are a few family physicians who provide their CHD     patients with supervised exercise (30 minutes of pedaling on an stationary bicycle at 60-85%     of the peak heart rate (HR) attained at the maximal or symptom limited treadmill test, 3     times a week) at their primary care health centers, thinking that these patients improve     their functional capacity, quality of life, and the control of cardiovascular risk factors,     more than walking because they can not achieve the ideal exercise intensity for maximal     benefits by walking. This study has been designed to investigate if CHD patients get more     health benefits with the supervised exercise program at the health center than with the     unsupervised walking program.   "
176583|NCT00155818|"     Several chromosomal loci obtained from genetic linkage studies have been reported of relating     to schizophrenia. These areas include of 1q32-41, 6p24-21, 8p22-21, 15q13-14, and 22q11-12.     The names of these genes located in these loci have not been identified, nor have the     function and the relationship to the disease. Our research team using genetic linkage studies     has found a strong linkage (NPL Z score = 2.18, p=0.01) between the D1S251 marker and     schizophrenia disease. This marker is about 4 kb away from DISC1 (disrupted in schizophrenia     gene 1) gene. In a Scottish family, a balanced translocation [t(1;11) (q42.1;q14.3)] has     cosegregated inside the schizophrenia affected members of the family (LOD score =6.0). The     breakpoint of the translocation is located at the intron area between exon 8 and exon 9 of     DISC1 gene. This translocation disrupted the gene and caused its malfunction. A large     molecular genetic study study recently in Finland has also demonstrated strong linkage     evidence (Zmax=3.21) between the DIS2709 marker, located among exon 4 and exon 5 of DISC1     gene, and schizophrenia in a. All these findings have indicated that DISC1 gene is a     potential positional candidate gene and worth for further study.      The main purposes of this proposal include: (1) To evaluate the incidence rate of the     balanced translocation between the chromosome 1q42.1 and 11q14.3 in approximately 500     schizophrenic patients in Taiwan. Furthermore, we will compare the clinical symptoms, illness     course, and family genetic model to examine if any particular characters coexist with the     translocation. (2) To search for the genetic polymorphisms in DISC1 gene area, where the     thirteen exons, the promoter regions (1 kb upstream the start codon), and the breakpoint area     (1 kb of both upstream and downstream area) will be analyzed by the method of denaturing high     performance liquid chromatography (DHPLC). Case-control association study will be performed     further in each 200 schizophrenic patients and normal controls to evaluate the relationship     between the disease and the clinical characteristics.      This proposal is quite feasible and prospective with the following reasons. (1) All the DNA     samples and the clinical data have been collected and evaluated completely for further     analysis. (2) Our research team has built up an integrated andreliable molecular genetic     laboratory. All the facilities necessary for this study (DHPLC) had been setup with standard     operating protocols and working routinely. (3) DISC1 gene has strong linkage evidence with     schizophrenia in Taiwanese sample. The high prior probability of DISC1 gene as a positional     candidate gene increases the successfulness of association study. . (4) Once the relationship     among balance translocation, genetic polymorphism and the schizophrenia have established,     further functional study will be evaluated to understand the possible mechanisms involved in     the disease.   "
176584|NCT00155831|"     Current approaches to treatment of premature infants at risk for neurodevelopmental     disabilities have emphasized early assessment and intervention within the first year of life     to optimize their developmental outcome. However, the information concerning the course of     early neuromotor development and the factors contributing to neurodevelopmental disabilities     in premature infants with CLD is limited. Therefore, the major purposes of this three-year     multi-centered developmental follow-up study are threefold. (1) We will prospectively     evaluate the early neuromotor performance of premature infants with CLD and premature infants     without CLD from birth until 12 months of corrected age. (2) We will follow up the     neurodevelopmental outcome of these infants at 12,18 and 24 months of corrected age to     identify the early neuromotor impairments that predict later neurodevelopmental disabilities.     (3) We will examine two potential influencing factors i.e., respiratory disease itself and     brain lesions that may contribute to the neurodevelopmental disabilities in premature infants     with CLD.   "
176585|NCT00155844|"     Bone marrow consists of a complex hematopoietic cellular component.When the blood progenitor     cells differentiate to mature cells, they will exit unassisted to peripheral blood. On the     other hand, the immature cells trapped by marrow-blood barrier. However, malignant     transformation of the hematopoietic progenitor cells in AML and CML results in a blockade of     their ability to terminally differentiate, causing a rapid accumulation of immature     cells.Chemokines have been shown to direct the movement of cells between intravascular and     extravascular compartments.The CXC chemokine CXCL12, the ligand of CXCR4, activates distinct     signaling pathways that may mediate cell migration.In the preliminary research, we analyze     the CXCR4 expression and the chemotactic response of CXCL12 and peripheral plasma in six     leukemia cell lines (HL-60, HL-CZ, K562, U937, Raji and Jurkat) and found that three     categories among them could be suggested: one is CXCR4 (-) and CXCL12 response (-), such as     HL-CZ and K562 cells; the other is CXCR4 (+) and CXCL12 response (-), such as HL-60 and Raji     cells; the rest is CXCR4 (+) and CXCL12 response (+), such as Jurkat and U937 cells. These     results make us wonder that the leukemic cells could egress to PB from BM is due to     destruction of homing process or the activation of mobilization process through CXCR4-CXCL12     axis dysfunction. Therefore,we will focus on evaluating the mechanism of CXCR4-CXCL12 axis     dysfunction in the various leukemic cell lines and primary leukemic cells.   "
176586|NCT00155857|"     The purpose of this study is to evaluate the possible candidate gene of Primary Angle-Closure     Glaucoma.   "
176587|NCT00155870|"     Laparoscopic assisted vaginal hysterectomy (LAVH)has become the most prevalent operation     method in woman suffering from uterine myoma or adenomyosis nowadays. The operation decisions     for these women are always due to symptoms such as pain, anemia and mass effect. However,     there is a lack of measurement for these symptoms and therefore highlight the need to     validate these symptom by health-related quality of life (QOL) assessments. Patients usually     recovered better by LAVH comparing to traditional open surgeries. However, LAVH was     restricted to cases with small size uteri and most QOL reported neglected uterine weight or     were based on small uteri size. We recently intervened a new surgical procedure called RULU     during LAVH and thus released this limitation. This will give a more unbiased study on the     effect of QOL in patients receiving LAVH. In this study, we plan to use two questionnaires:     the disease specific UFS-QOL and the WHO-QOL Taiwan version questionnaires for patients     receiving LAVH. Assessment will be performed before operation; and 3 days, 7 days, 3 months     and 18 months after operation. From these assessments, we plan to determine which QOL     variables will be useful as operation guidelines for patients suffering from leiomyoma or     adenomyosis, and for the assessment of appropriates and outcomes of LAVH.   "
176588|NCT00155883|"     The primary objective is to determine the tumor response rate of bi-weekly docetaxel plus     24-hour infusion of high-dose 5-FU/leucovorin chemotherapy for patients with inoperable     advanced gastric cancer.   "
176611|NCT00146328|"     The objective of this study is to determine the long term safety and tolerability of multiple     oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the     development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other     antiretroviral medications.   "
176612|NCT00146341|"     To demonstrate that a fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg is     superior to telmisartan 80 mg alone in patients, who fail to respond adequately to     telmisartan 80 mg monotherapy, in lowering seated trough diastolic blood pressure after eight     weeks of treatment.   "
176613|NCT00146354|"     This project aims to define the problem of results that return after patient discharge and to     study the implementation of an Electronic Medical Record (EMR)-based system for tracking     these results.   "
176756|NCT00148590|"     The purpose of this study is to evaluate the efficacy and safety of memantine as add-on     treatment for the prevention of negative symptomatology in patients with an acute     exacerbation of schizophrenia.      Primary outcome parameter are negative symptoms after 6 months   "
176589|NCT00155896|"     Ovarian cancer is the first mortality rate of gynecologic malignancies. The incidence of     ovarian cancer increased in recent 10 years. Ovarian cancer indeed is a disease that should     be respected, however, there were only few of research work focusing on it in Taiwan.      To study the mechanisms of carcinogenesis of ovarian cancer will help us understand this     disease and develop new strategies of diagnosis and prevention for ovarian cancer in the     future. The present diagnostic methods of malignancy are clinical symptoms, physical     examination, evaluation of tumor markers and instruments. It is a important issue to diagnose     cancer earlier to improve the survival of cancer patients. By the development of biomedical     science, many genes have been identified to be related with the carcinogenesis. If we can     detect the possibility of genetic mutation earlier, we may deal with the suspected areas of     malignancy as soon as possible. To our present knowledge, carcinogenesis of ovarian cancer     has strong correlation with some special genes such as BRCA1 and BRCA2 genes. There is 1 out     of 200 normal population with BRCA1 or BRCA2 gene mutation in the western countries. The     incidences of BRCA1 or BRCA2 gene mutation even increase to 30-50% in the population of     familial ovarian cancer. Women with BRCA1 gene mutation have 80% to get breast cancer before     the age of 70 and 63% of them would get ovarian cancer before the age of 70. Women with BRCA2     gene mutation have 80% to get breast or ovarian cancer before the age of 70. It seems that     the genetic diagnosis of BRCA1/BRCA2 has its clinical practice. The development of new     instrument- denaturing high-performance liquid chromatography (DHPLC) is to use automated     detection to find out the minute or single mutation of nucleotide. It has been applied to the     clinical service by utilizing DHPLC for the genetic diagnosis of BRCA1 and BRCA2 of breast     cancer patients in the department of Genetic Medicine of our hospital. It will become a most     powerful tool to establish the database of BRCA1 or BRCA2 gene mutation of the ovarian cancer     patients in Taiwan, when we can use the technique of DHPLC combining with the direct DNA     sequencing.   "
176590|NCT00155909|"     A prospective observational study to evaluate clinical, dosimetrical, functional, and     biological factors in predicting radiation pneumonitis.   "
176591|NCT00155922|"     The investigators hypothesize that macrophages play a crucial role in the pathogenesis of     atherosclerosis in patients with type 2 diabetes mellitus (T2DM).   "
176592|NCT00155935|"     Ovarian cancer has the highest mortality rate of gynecologic malignancies and the overall     5-year survival rate of ovarian cancer is only 20-30%. Additionally, the incidence of ovarian     cancer has increased in recent years in Taiwan. Ovarian cancer is indeed a disease that     should be respected, however, there was very little research work focusing on it in Taiwan.     Patients with ovarian cancer who have stage I disease (localized to ovaries) after optimal     surgical staging do not need any adjuvant therapy. In contrast, patients with cancer     spreading beyond the ovaries have median survival rates that decrease to less than (<) 10%     for patients with bulky residual disease after surgery and treatment with platinum-based     combination chemotherapy. In developing effective therapy for ovarian cancer, there should be     a distinction between preventative and therapeutic approaches. Immunoprevention will be     developed for women who are at an increased risk for the development of ovarian cancer. In     contrast, immunotherapy would be used as an adjuvant to surgery or in combination with     chemotherapy or other biologics such as chemoimmunotherapy or biochemoimmunotherapy. The     folate receptor (FR) is expressed in some normal epithelial cells and is elevated in certain     carcinomas. The FR has been reported to be selectively overexpressed in 90% of non-mucinous     ovarian carcinomas. The specific epitopes of the folate receptor in the HLA-A2 haplotype have     been identified. It appears that the folate receptor could be a target antigen for the     immunotherapy of ovarian cancer.      Therefore the investigators would like to propose the development of folate receptor-specific     immunologic assays. There are two aims in this project:        1. to develop and utilize assays to measure cytotoxic T-lymphocytes (CTLs) to folate          receptors, and        2. to evaluate the folate receptor-specific immunologic responses between normal controls          and ovarian cancer patients.   "
176593|NCT00155948|"     The purpose of this study is to investigate the validity and reliability of measurement for     cervical multifidus using ultrasonography, and to investigate cervical multifidus muscle     function by the change pattern of multifidus thickness, and to compare the changes in muscle     thickness among different resistance levels (rest, 25%, 50%, 75% and 100%) and different     cervical levels (C4, C5 and C6).   "
176594|NCT00155961|"     Introduction      Male ageing is associated with sarcopenia, frailty, osteopenia, obesity, the metabolic     syndrome and cardiovascular disease. To what extent the androgens affect these signs of     ageing is still largely undetermined. A few studies have shown divergent results concerning     the relation between ageing and serum levels of testosterone. It still remains to be shown     whether there is a pure age-related decline in serum testosterone or whether other factors     such as obesity, chronic illness or medication are responsible for the lower serum     testosterone found in elderly men when compared with young men. To investigate these issues a     cohort of 600 men aged 60 to 75 years is examined.      Objective      The aim of the study is to investigate the relation of testosterone (T) to body composition     (BC) and physical performance (PP). Measures for BC are muscle mass (MM), bone mineral     density (BMD) and fat mass (FM). Parameters for PP are maximum voluntary force (MVF), maximum     oxygen uptake (VO2max) and muscle power (P). We hypothesize that T is positively associated     with MM, BMD and all PP parameters, but negatively associated with FM. We will furthermore     examine whether life style, medication, chronic disease, hormones and binding proteins exert     their actions on BC and PP solely through or independently of T. The levels of s-total and     free T in this cohort will be compared with the s-total and free T levels from a cohort of     young men aged 20 to 30 years. Furthermore the associations found between T and BC and PP in     the two cohorts will be compared to investigate whether T plays the same role in the two     groups.   "
176595|NCT00155974|"     The purpose of this study is to develop and determine the effectiveness of a multi-level     community participatory intervention designed to rapidly immunize hard-to-reach populations,     including substance users, within disadvantaged minority communities.      Specific Aims of the project are as follows:        1. To identify the relative contributions of personal factors and structural barriers to          immunization status in hard-to-reach populations.        2. To estimate the size of the hard-to-reach population in specified disadvantaged urban          communities using venue-based sampling, probability-based sampling, capture-recapture          methods and modified Delphi techniques.        3. To compare vaccination rates in hard-to-reach populations between neighborhoods that          receive a community-based vaccine outreach intervention versus neighborhoods where          vaccines are offered through standard public health programs, using an incremental          crossover multilevel community intervention design.   "
176596|NCT00155987|"     This is a multi-centre randomised trial to evaluate the effect of early decompressive     craniectomy on neurological function in patients with severe traumatic brain injury.      The primary outcome is neurological function measured at 6 months post injury using the     Glasgow Outcome Score. Neurological function is qualified as proportion of favourable     outcomes (Glasgow Outcome Score Extended [GOSE] grades 5-8).   "
176597|NCT00156000|"     Among women with a twin pregnancy, currently enrolled in a study in which they are receiving     weekly injections of 17-alpha-hydroxyprogesterone caproate verses placebo injections, fetal     fibronectin (fFN) and salivary estriol (E3 ) will identify the following.        1. Women at increased risk for preterm delivery.        2. A subpopulation, among those receiving the active drug, who may respond to progesterone.      If fFN and/or E3 identify a population of patients who respond to progesterone, these     diagnostic tests may define women who may or may not be good candidates for progesterone     therapy.   "
176705|NCT00147927|"     The purpose of this research is to evaluate the efficacy of a multi-component email health     promotion program on employee adoption of health promoting behaviors and secondarily on     health status, work productivity and health care costs.   "
176602|NCT00156065|"     Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by     Positive symptoms (symptoms that should not be there, inability to think clearly, to     distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or     absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and     relate to others). Other symptoms include reduced ability to recall and learn new     information, difficulty with problem solving, or maintaining productive employment. The     symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily     dopamine and serotonin, which enables brain cells to communicate with each other.      The clinical development of asenapine, as described in the 2007 IDB appears to have     antipsychotic activity with superior symptomatic control compared to placebo and an improved     safety profile compared to currently available neuroleptics. Its fast dissolving formulation     may further add to treatment compliance. While various titration schedules have been used in     previous studies, dose increases at 5 mg BID (twice daily) up to 10 mg BID have been well     tolerated. Therefore, further exploration in a larger group of subjects with acute     exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID)     will mimic actual clinical practice in a long-term 52-week extension trial.   "
176603|NCT00156078|"     A study of pregabalin efficacy and safety in a racially and culturally diverse group of     subjects with painful diabetic peripheral neuropathy (DPN).   "
176604|NCT00156091|"     Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by     Positive symptoms (symptoms that should not be there, inability to think clearly, to     distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or     absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and     relate to others). Other symptoms include reduced ability to recall and learn new     information, difficulty with problem solving, or maintaining productive employment. The     symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily     dopamine and serotonin, which enables brain cells to communicate with each other.      The clinical development of asenapine, as described in the 2007 IDB appears to have     antipsychotic activity with superior symptomatic control compared to placebo and an improved     safety profile compared to currently available neuroleptics. Its fast dissolving formulation     may further add to treatment compliance. While various titration schedules have been used in     previous studies, dose increases at 5 mg BID up to 10 mg BID have been well tolerated.     Therefore, further exploration in a larger group of subjects with acute exacerbation of     schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID) will mimic actual     clinical practice in a long-term 52-week extension trial.   "
176605|NCT00156104|"     Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by     Positive symptoms (symptoms that should not be there, inability to think clearly, to     distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or     absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and     relate to others). Other symptoms include reduced ability to recall and learn new     information, difficulty with problem solving, or maintaining productive employment. The     symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily     dopamine and serotonin, which enables brain cells to communicate with each other.      Asenapine is an investigational drug that may help to correct the inbalance in dopamine and     serotonin. This is a 6-week trial to test the efficacy and safety of asenapine, compared with     placebo, using an active comparator agent (haloperidol) in the treatment of patients with an     acute exacerbation of schizophrenia. Patients who complete the 6-week trial will have the     option of continuing in an additional one year extension trial.   "
176606|NCT00156117|"     Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by     Positive symptoms (symptoms that should not be there, inability to think clearly, to     distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or     absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and     relate to others). Other symptoms include reduced ability to recall and learn new     information, difficulty with problem solving, or maintaining productive employment. The     symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily     dopamine and serotonin, which enables brain cells to communicate with each other.      Asenapine is an investigational drug that may help to correct the imbalance in dopamine and     serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a     comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that     complete this trial will have the option of continuing in an additional one year extension     trial.   "
176607|NCT00156130|"     This study is evaluating the long-term outcomes of women in a randomized trial that compared     accelerated whole breast irradiation (42.5 Gy in 16 fractions over 22 days) to a longer     conventional schedule of whole breast irradiation (50 Gy in 25 fractions over 35 days)     following breast-conserving surgery. The outcomes evaluated will include cosmetic outcome and     cardiac disease as a measure of late radiation morbidity and local breast recurrence as a     measure of effectiveness.   "
176608|NCT00146289|"     The primary objective of this study is to determine whether MICARDIS® improves insulin     sensitivity in overweight or obese, non-diabetic, normotensive subjects.   "
176609|NCT00146302|"     The World Health Organization (WHO) currently recommends BCG vaccination at birth in     developing countries. Pre-term infants should be vaccinated when they reach the chronological     age of 40 weeks. Due to difficulties in establishing the correct gestational age, the     vaccination policy for BCG in many developing countries is defined by birth weight rather     than by gestational maturity. In the study area, low birth weight (LBW) infants (< 2500 g)     are not supposed to be vaccinated at birth; instead the mother is asked to return for     vaccination when the child has gained sufficient weight. BCG has marked immune stimulatory     effects in both animal and human studies and observational studies suggest that BCG is     associated with a non-specific reduction in mortality in areas with high infant and child     mortality. The specific objective of the study is to examine the effect of early vaccination     of LBW children for adverse events, purified protein derivative of tuberculin (PPD) reaction,     scar size, morbidity, and mortality in a randomised prospective study of BCG vaccination at     birth versus later (according to policy) among children 19 months of age in Guinea-Bissau.     The hypothesis is that BCG vaccination of low birth weight (LBW) children at birth reduces     infant mortality of this high-risk group by 25%.   "
176614|NCT00146367|"     The primary goal of this study is to assess the effectiveness and feasibility of the Active     Living Every Day Physical Activity Program (ALED) for people with arthritis. This project is     designed to evaluate the effectiveness of the ALED program in changing arthritis-related     health outcomes and to investigate the feasibility of conducting the ALED program in a public     health setting.   "
176615|NCT00146380|"     The purpose of the study is to demonstrate that a regimen using highly active antiretroviral     therapy (HAART) to maximally suppress maternal viral load in the late antenatal period and     during the first six months of lactation is safe, effective and can be implemented in     resource poor settings in order to reduce the risk of HIV transmission to the infant.   "
176616|NCT00146393|"     The primary goal of this study is to assess the effect of People with Arthritis Can Exercise     (PACE), a community-based group recreational exercise program, on key arthritis-related     health outcomes among adults with arthritis.   "
176617|NCT00146406|"     Sexually active adolescents between the ages of 10 and 19 are at extremely high risk for     sexually transmitted diseases (STD), including HIV, and teen pregnancy.The overall goal of     this research program is to develop, implement and evaluate integrated multi-level     interventions to prevent STD, including HIV, and pregnancy among adolescents. The study     includes 12 high schools and 19 of their feeder middle schools in the Los Angeles Unified     School District and the surrounding communities. Interventions will be implemented among     parents, health care providers, and in schools in an integrated fashion with the goal of     improving social context factors related to health outcomes among adolescents. The evaluation     phase will include in-school surveys with adolescents at all middle schools   "
176618|NCT00146718|"     The project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ),     sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their     baseline characteristics for malaria. In addition, drug resistance will be determined by     measurement of blood drug levels,and identification of molecular markers of resistance.   "
176619|NCT00146731|"     Pregnant women are vulnerable to malaria, with significant implications both for their health     and for the pregnancy. Sulfadoxine-pyrimethamine (SP) is currently the first line drug for     the treatment of malaria in pregnancy in Tanzania and surrounding countries, but resistance     is emerging rapidly. Alternative drugs must be found, and new drugs and drug combinations are     being recommended by many for deployment as first line treatment at the point that SP     resistance forces a policy change. However, there are few data on the safety and efficacy of     these combinations in pregnant women. This randomised trial aims to assess efficacy and     safety, including birth outcome, in pregnant women with malaria in the second or third     trimesters. A total of 900 pregnant women will be randomised either to standard treatment     (SP) or to one of three potential drugs, or drug combinations recently recommended by a WHO     expert panel. These will be SP-amodiaquine, chlorproguanil-dapsone (Lapdap), and     amodiaquine-artesunate. Primary outcome will be treatment failure. Secondary outcomes will     include 28 day slide clearance, maternal side effects, foetal viability and birth outcome.   "
176620|NCT00146744|"     This study will evaluate the safety, reactogenicity and immunogenicity of Mtb72F/AS02A in     healthy European volunteers who are PPD-positive either via previous vaccination with BCG     and/or conversion to PPD positivity through exposure to Mycobacterium tuberculosis.   "
176621|NCT00146757|"     The main objectives of this study are to evaluate the safety and pharmacokinetics (PK) of     enzyme replacement therapy with recombinant human alpha-L-iduronidase [Aldurazyme®     (laronidase)] in mucopolysaccharidosis I (MPS I) patients less than 5 years old. Efficacy     measurements will also be evaluated in this study.   "
176622|NCT00146770|"     This study is being conducted to collect additional long-term efficacy and safety data of     Aldurazyme® (laronidase) patients with MPS I disease. Patients who were previously enrolled     in the Phase 3 Double-Blind Study will be enrolled in this study.   "
176623|NCT00146783|"     In areas of stable transmission, pregnant women, especially during the first and second     pregnancies, have an increased susceptibility to Plasmodium falciparum malaria,     malaria-related anaemia and an increased risk of having low birthweight babies. Intermittent     Preventive Treatment in pregnancy(IPTp) with sulphadoxine-pyrimethamine has been shown to be     effective in reducing the effects of malaria in pregnancy. This has mainly been in areas of     perennial transmission and there is a need to study this effect in intense seasonal     transmission settings. The emergence and spread of resistance to SP is likely to undermine     its useful lifespan and it is important that other antimalarials that are safe and effective     are identified for use in IPTp. The options are however limited. Amodiaquine has been shown     to be effective in treatment of clinical cases of malaria, even in areas where chloroquine     resistance is prevalent, and its combination with SP has been associated with favourable     results. Both are affordable. However, there is limited data on their use in pregnancy. This     study aims to assess the efficacy of SP in an area of intense seasonal transmission, and     evaluate the safety and efficacy of amodiaquine and a combination of     sulphadoxine-pyrimethamine and amodiaquine as possible alternatives to SP for use as IPTp.   "
176624|NCT00146796|"     There is clear evidence diagnosis of malaria in much of Africa is sub-optimal and this has a     negative impact on patient care. Many of those treated for malaria do not have it. Rapid     diagnostic tests (RDTs) are dipsticks which diagnose malaria rapidly and accurately. The main     objective of this trial is to determine by means of a randomised trial the impact of     introducing RDTs into a standard outpatient setting in Tanzania has on the appropriate     prescription of antimalarials. Other objectives are:        1. To compare at high, moderate and low P.falciparum transmission intensity the sensitivity          and specificity of malaria diagnosis using hospital slide results and RDTs, using          research quality slides as the reference.        2. To estimate the specificity of clinical diagnosis of malaria at high, moderate and low          transmission intensity of P. falciparum.        3. To compare the proportion of cases reported as slide-negative who are treated for          malaria with the proportion of RDT-negative cases treated for malaria.        4. To evaluate the cost effectiveness of introducing RDTs compared to current diagnostic          practice in facilities with microscopic diagnosis of malaria at different levels of          transmission of P.falciparum.   "
176774|NCT00148837|"     Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of     developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to     make hepatic fibrosis regress, in patients with chronic hepatitis C and severe fibrosis.   "
176625|NCT00146809|"     Study Hypothesis:      - Does a treatment with Minocycline of 2 x daily 2 x 50 mg effect the progression of clinical     symptoms and diagnosis in patients with MSA?      Background and Rationale:        -  The Parkinson-Syndrome which is characterised by the clinical triad akinesis, rigor and          passive tremor, is caused by Parkinson’s disease (PD) in about 70 % of the cases (Oertel          et al., 2003). However, beside the Parkinson’s disease there are several, to some extent          rare, so-called atypical Parkinson’s syndromes. The two most frequent of these atypical          Parkinson-Syndromes are the        -  Multi-System-Atrophy (MSA) and the Progressive Supranuclear Palsy (PSP). Due to the          often much varying courses and since they are not well known, these diseases are          frequently diagnosed late or not diagnosed at all. Nevertheless, an early diagnosis is          substantial for further treatment, since the prognosis and therapy of atypical Parkinson          Syndromes differ essentially from those of PD. Whereas the neuronal death of cells in PD          is restricted essentially to the Substantia nigra, a dominant destruction of neurons in          brain stem, Cerebellum and Striatum additionally happens in cases of MSA and PSP.        -  Up to now no adequate treatment strategies are at disposal. Initially the giving of          L-Dopa can lead to an improvement for < 10% of the patients only.        -  Minocycline is an antibiotic belonging to the group of the Tetracyclines.        -  Recently, it could be demonstrated that Minocycline has a neuroprotective impact besides          the anti-inflammatory impact.   "
176626|NCT00146822|"     The REFLEx Study will evaluate if ENDOTAK RELIANCE G defibrillation leads with GORE     ePTFE-covered coils are as good as or better than other comparative commercially available     defibrillation leads with respect to electrical performance and termination efficacy in     spontaneous tachyarrhythmic episodes.   "
176627|NCT00146835|"     Pre-licensure studies of GSK Biologicals' PEDIARIX vaccine have shown it to be generally safe     and unlikely to result in vaccine-associated serious adverse events. This post-licensure     study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort.   "
176628|NCT00146848|"     This study will look at different pacing modes (how a device is programmed to pace one's     heart), and how these modes may assist in one's daily activities and how one is feeling.   "
176629|NCT00146861|"     This study will compare how two different sensors inside the pacemaker may affect patients'     quality of life.   "
176630|NCT00146874|"     This registry will provide detailed patient demographics and characteristics at the time of     enrollment and will also provide data regarding predictors of clinical outcomes such as heart     failure decompensation, heart failure hospitalization, NYHA class, and quality of life.   "
176631|NCT00146887|"     The purpose of the trial is to investigate the accuracy of coronary CT compared to the     conventional gold standard cardiac catheterization.   "
176632|NCT00146900|"     To prospectively evaluate the effect of early treatment (cognitive therapy (CT),     cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of     post-traumatic stress disorder in recent survivors of traumatic events.   "
176633|NCT00146913|"     Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses     (CCR) at 18 months. So, 40% of the patients must receive additional treatment. In vitro, it     has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on     chromosome Ph+ cell lines. By using Peg-Interféron and IM combination, we hope to increase     the cytogenetic response of patients.   "
176634|NCT00146926|"     Propofol is a popular intravenous drug to induce anesthesia but it causes local pain with an     incidence between 40 and 90%. Three different strategies to prevent propofol induced pain     will be studied compared with placebo. Pain will be scored with a four-point scale.   "
176635|NCT00146952|"     The investigators propose to explore the hypothesis that vibrotactile channels for indicating     spatial orientation can be exploited as a sensory prosthesis. The specific research     applications will be used for guiding visual orientation, to provide alternative feedback to     vision and vestibular signals for controlling balance, and for directional and lateralisation     cueing in patients with neglect syndromes. The programme will study whether vibrotactile     feedback improves performance and also if it speeds rehabilitation when used as an adjunct to     conventional therapy.   "
176636|NCT00146978|"     Graft versus host disease (GVHD) is a major complication of allogeneic bone marrow     transplantation (BMT), resulting in death in the majority of steroid resistant patients. The     study was designed to assess the efficacy of regional intra-arterial treatment in patients     with resistant hepatic and/or gastro-intestinal GVHD.   "
176637|NCT00147004|"     The purpose of the study is to determine whether steroids decrease 28-day mortality in     patients with septic shock.   "
176638|NCT00147017|"     The aim of this study is to investigate the mechanisms whereby specific white cells called     macrophages found in the lung release inflammatory mediators or chemicals together with     enzymes that destroy the surrounding lung tissue. The hypothesis is that in diseases such as     chronic obstructive pulmonary disease (COPD), lung macrophages release either more or     different types of inflammatory mediators and/or destructive enzymes compared to subjects     without COPD. We will isolate macrophages from small pieces of lung parenchyma. These samples     are derived from lobes resected for carcinoma of the lung. We would aim to examine the     responses of tissue derived macrophages in three groups of subjects, namely (i) non-smoking     controls (lung carcinoma as secondary metastasis), (ii) smokers without clinical or     histological signs of COPD and (iii) smokers with COPD. The resected lung tissue will be cut     into small pieces and washed in order to release the macrophages from the tissue. The     macrophages will then be isolated from other cell types in the washings. We will then use     these isolated cells in vitro to examine the cell surface receptors in order to compare these     macrophage cells with macrophages reported from bronchoalveolar lavage and monocyte derived     macrophage models. We will then examine inflammatory mediator synthesis and release following     stimulation of these cells. We will also examine the regulation and release of enzymes known     to damage lung tissue. Using these two models we will then examine the signal transduction     pathways that lead to this activation of the macrophages and investigate the effects of novel     therapeutic agents to inhibit inflammatory mediator and/or enzyme synthesis and release. The     objective is to identify the mechanisms whereby macrophages respond to pro-inflammatory     conditions seen in COPD with a view to identify novel targets for drug therapy.   "
176639|NCT00147030|"     Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial     encephalopathy reduces death and severe neurodevelopmental disability.      This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that     improves survival, without severe neurological or neurodevelopmental impairments at 18     months, of term infants suffering perinatal asphyxial encephalopathy.   "
176640|NCT00147043|"     In order to determine the clinical application potential of adult stem cells we propose to     investigate the safety and toxicity of infusing adult stem cells in the hepatic artery or     portal vein of five patients with chronic liver insufficiency and to identify any clinical     benefit if such occurs.      Objectives:        1. To assess safety and treatment related toxicities        2. To determine clinical benefit or deterioration by monitoring changes in liver function   "
176641|NCT00147056|"     The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal     ablation of brain tumors performed through intact human skull using the ExAblate transcranial     system. We will collect data to establish the basic safety of this type of treatment as the     basis for later studies that will evaluate its clinical efficacy.   "
176642|NCT00147069|"     The aim of this study is to examine the inflammatory mechanisms involved in the pathogenesis     of inflammatory lung disease, in particular to compare the inflammatory profile seen in     asthma and COPD. Evidence for inflammation in asthma and COPD is based on the finding of     increased numbers of macrophages and neutrophils in the lungs and respiratory secretions of     these patients. The inflammatory cells produce proteases, as well as, reactive oxidant     species resulting in a protease/anti-protease imbalance which favours lung destruction. The     aim is to examine the inflammatory mediators released by inflammatory cells (such as,     macrophages and lymphocytes) in order to determine whether there are differences between     non-smoking subjects, smoking subjects and patients with asthma or COPD. Monocytes are     precursors of alveolar macrophages, and both monocytes and neutrophils are recruited to the     lung from the blood via the action of specific chemoattractants. We have evidence that in     inflammation there are higher levels of these chemoattractants. Therefore these cells might     also demonstrate the same changes seen in alveolar macrophages from these patients.      We also aim to assess the role of the macrophage precursor (monocyte) and neutrophils in the     blood. We will also assess lymphocyte/monocyte interaction. We will do this as the lymphocyte     may be involved in the initial recruitment of inflammatory cells. We will also assess the     role of cytokines involved with monocyte/macrophage/neutrophil migration in induced sputum as     well as the role of induced sputum in the migration of monocytes and neutrophils into the     lung. Our aim is to link the initial changes in blood to the changes causing disease in the     lungs. We aim to examine cellular responses in four groups of subjects, namely (i)     non-smoking controls, (ii) smokers without clinical evidence of COPD or asthma, (iii) smokers     with COPD (iv) asthmatic patients.   "
176643|NCT00147082|"     The aim of this study is to investigate the mechanisms whereby leukocytes are recruited to     the lung in chronic obstructive pulmonary disease (COPD) and cause tissue destruction. The     hypothesis is that in COPD more leukocytes enter the lung and it is these cells that are     responsible for the degradation of lung tissue. We, the researchers at Imperial College     London, will isolate leukocytes from the blood of patients with COPD, healthy smokers and     normal subjects and measure the movement of the leukocytes to chemoattractants. We will     examine further, which cell surface receptors are responsible for this trafficking of cells.     Furthermore, the differentiation of these cells in vitro will be compared with cells from     healthy smokers and normal subjects. Specifically, the expression of enzymes that are     responsible for tissue destruction and the cell surface receptors on these cells will be     investigated. The objective is to identify the mechanisms whereby leukocytes from COPD     patients behave differently to cells from healthy smokers and normal subjects with a view to     identify novel targets for drug therapy.   "
176644|NCT00147095|"     The aim of this study is to investigate the mechanisms whereby lung function is decreased in     COPD. The hypothesis is that in diseases such as COPD, inflammatory cells including     neutrophils, macrophages and lymphocytes migrate to the lung and release either more or     different types of inflammatory mediators and/or destructive enzymes compared to subjects     without COPD. We aim to investigate these separate cell types in the blood of subjects with     COPD and identify which genes are more highly expressed when compared to cells obtained from     patients without COPD. We will also investigate the lung macrophages from these subjects to     identify whether the same or different genes are expressed in these cells. We will isolate     different leukocyte populations from the blood and extract ribonucleic acid (RNA) from these     samples. The type and quantity of RNA in these samples is a reflection of the specific genes     expressed in these cells. This RNA will be sent to Gene Logic and this company will test     these samples to identify which genes have been expressed. Similar experiments will be     performed using macrophages obtained following bronchoalveolar lavage of these subjects. We     would aim to examine the responses of leukocytes from three groups of subjects, namely (i)     non-smoking controls (ii) smokers without clinical or histological signs of COPD and (iii)     smokers with COPD. The isolated leukocytes will either be immediately solubilized in     solutions to purify RNA or we will then use these isolated cells in vitro and following     stimulation investigate whether different genes are expressed or at a differential rate in     the disease state. The objective is to identify which genes are specifically expressed in     patients with COPD with a view to identify novel targets for drug therapy. We will examine     both leukocytes derived from peripheral blood and macrophages obtained from bronchoalveolar     lavage with the aim to determine whether differences attributable to disease can be     identified in both circulating cells and those at the site of disease. This is a preliminary     study to determine the profile of inflammatory mediator expression from leukocytes and as     such power calculations to determine the number of subjects is not appropriate.   "
176645|NCT00147108|"     The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS     treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a     fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional     area of > 50% on palpation, and >65% in lesion volume as measured by MRI (both calculations     assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size,     along with the softening of the treated volume will result in satisfactory clinical results     in greater than 50 % of the patients.   "
176646|NCT00147121|"     To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma   "
176647|NCT00147134|"     The purpose of this study is to evaluate oncological outcome of patients for T3 and T4     colorectal cancer undergoing laparoscopic versus open surgery.   "
176648|NCT00147147|"     To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or     greater lymph node dissection in T3-4 gastric cancer patients.   "
176649|NCT00147160|"     The purpose of this study is to determine whether the combination of Temozolomide and     Cisplatinum is effective in the treatment of malignant glial tumours of children and     adolescents   "
176650|NCT00147186|"     The use of Hylan G-F 20 as a treatment of osteoarthritis (OA) of the knee has become popular     in recent years. Typical treatment of OA of the knee includes NSAIDs and physical therapy     protocols to strengthen local muscle groups and decrease pain. When these conservative     treatment modalities have been exhausted, the next step is arthroplasty of the knee. Hylan     G-F 20 treatments provide physicians with an intermediate mode of treatment prior to surgery.     Hylan G-F 20 is a cross-linked, high molecular weight derivative of hyaluronan which can be     found within the synovial capsule of the knee. This form of viscosupplementation is intended     to reduce the pain suffered by those with OA by increasing the fluid levels within the     synovial space, providing a cushion between the bony surfaces within the knee joint. Current     studies have only looked at self-reported pain relief or Outcomes Inventories. This study     aims to determine the ability of Hylan G-F 20 treatment to improve the parameters of gait of     individuals who suffer from OA.   "
176651|NCT00147199|"     This is a double-blind placebo-controlled clinical investigation into the efficacy and     tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.     The primary outcome is the change in 6-minute walk distance from baseline to week 12.   "
176652|NCT00147212|"     The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743)     has on men with advanced prostate carcinoma.   "
176713|NCT00148031|"     The overall goal of the research project is to improve the outcome of medical care for     injection drug users (IDUs) with Hepatitis C viral (HCV) infection.      Hypothesis: An intervention designed to improve the rate of HCV treatment completion and     sustained virologic response (SVR) in IDUs will increase access by integrating HCV medical     care into a substance abuse treatment program.   "
176653|NCT00147225|"     The goal of this clinical research study is to find the highest safe dose of AMG 531 that     will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who     have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG     531 (Romiplostim).      Primary Objectives:        1. To determine the clinical safety and tolerability of AMG 531 administered following          chemotherapy in patients with advanced malignancy        2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients          receiving chemotherapy known to cause severe thrombocytopenia        3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and          platelet recovery following chemotherapy      Secondary Objective:      1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route     post-chemotherapy   "
176654|NCT00147238|"     The goal of this clinical research study is to evaluate how well ferumoxtran-10, a new     Magnetic Resonance Imaging (MRI) contrast agent, can detect cancer in the pelvic lymph nodes     or malignant pelvic lymph nodes.   "
176655|NCT00147251|"     Compared to standard treatment goals achieving lower targets for LDL cholesterol (bad     cholesterol) and blood pressure in people with diabetes will slow the progression of     atherosclerosis as measured by carotid artery thickness, and reduce clinical cardiovascular     events such as heart attacks and strokes. This study is a randomized 3-year trial. The     primary endpoint will be a combination of various measures of the carotid artery, (which is     an easy, non-invasive way to detect cardiovascular disease) and events such as heart attacks     and strokes. The study will also look at secondary endpoints such as how well the heart     pumps, fat,protein and inflammatory markers in the blood,and kidney function. The study     enrolled 549 American Indian men and women with diabetes, > 40 years of age and is being     conducted in four field centers involving Indian Health Service/Tribal primary care     facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota;     and Lawton, Oklahoma, with input from American Indian physicians and community members.   "
176656|NCT00147264|"     The purpose of this study is to determine whether telmisartan and/or a low-glycemic index     diet are effective in reducing intra-myocellular lipid (muscle fat) content.   "
176657|NCT00147277|"     The purpose of this study is to estimate and quantify the difference in efficacy of two     sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an     episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via     ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD     implantation, and thus to promote the painless therapy aspect of ICD treatment and improve     quality of life outcomes for patients.   "
176658|NCT00147290|"     To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in     patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I     or IIA indication for ICD implantation.      The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated in     a prospective, controlled and randomized study.   "
176659|NCT00147303|"     Sarpogrelate is an antiplatelet agent that decreases 5-hydroxytryptamine( 5-HT )levels in     platelets via blockade of 5-HT2 receptors, has been used in atherosclerotic peripheral     arterial disease.      The present double-blind controlled clinical pharmacology study was performed on 45 patients     with cerebral infarction, who were given 75, 150, or 300 mg three times daily of sarpogrelate     for 7 days in order to evaluate the dose-response relationship in terms of the precisely     measured inhibition of platelet aggregation.   "
176660|NCT00147316|"     Based on previous studies comparing Duteplase[a recombinant tissue plasminogen activator     (rt-PA) very similar to alteplase] doses, we performed a clinical trial with 0.6mg/kg, which     is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy     and safety of alteplase for the Japanese.   "
176661|NCT00147329|"     Merrimack is conducting a research study to see if an experimental drug, called MM-093, is     safe and effective in the treatment of psoriasis. MM-093 is a genetically engineered version     of a naturally occurring protein called alpha fetoprotein (AFP). Adults normally have very     small amounts of AFP in their bloodstream. However, during pregnancy, AFP levels in both the     mother and the fetus are much higher than normal. It has been observed that some women with     psoriasis and other autoimmune diseases such as rheumatoid arthritis have fewer symptoms     during pregnancy, particularly during the third trimester. At this time, the levels of AFP in     the blood of the mother and fetus are the highest. This observation led Merrimack to begin     examining MM-093 as a potential treatment for psoriasis. This study is designed to further     test the safety and effectiveness of MM-093 in patients with psoriasis.   "
176662|NCT00147342|"     Most children with type 1 diabetes have a drop in the blood sugar during exercise. This drop     in the blood sugar can result in hypoglycemia (low blood sugar). In children using an insulin     pump, there is an opportunity to reduce the basal insulin rate during exercise. This study is     being conducted to determine if decreasing the insulin that is received during exercise will     reduce the risk of hypoglycemia. We hope to learn more about how the body responds to     hypoglycemia and to hyperglycemia (high blood sugar) when it occurs.      As part of the study, children will have a visit on two different days. During each visit,     children will exercise on a treadmill for about 60 minutes. During one of the visits, the     children's basal rate will be continued during the exercise. During one visit, the basal     insulin will be stopped. The blood sugar will be checked frequently during the exercise.   "
176663|NCT00147355|"     This substudy is an open-label, randomised study comparing the uptake of recombinant     interleukin-2 (rIL-2) in HIV-1 infected individuals receiving different combinations of     antiemetics and analgesic agents during rIL-2 dosing in ESPRIT. The design is a factorial one     with 4 arms. All patients will receive regular ibuprofen and paracetamol from days 1-6 of the     rIL-2 dosing cycle; in addition, patients will be randomised to receive one of two antiemetic     combinations, i.e. ondansetron or metoclopramide with or without low dose codeine phosphate     as an additional analgesic agent.   "
176714|NCT00148044|"     Determination of the concentration of uremic toxins of sepsis patients with or without acute     kidney failure compared to the concentrations of uremic toxins of chronically uremic patients   "
176773|NCT00148824|"     Streptococcus pneumoniae is the major cause of bacterial infection in HIV-infected patients.     The current pneumococcal vaccine is poorly efficacious in patients with a CD4 cell count     lower than 500/mm3. This study will test the efficacy and safety of a new pneumococcal     vaccine strategy in patients with a CD4 cell count between 200 and 500/mm3.   "
176664|NCT00147368|"     Acute falciparum malaria is associated with low plasma arginine and impaired nitric oxide     (NO) production. Both are associated with poor outcome. This study will examine the safety     and effect of escalating doses of arginine in falciparum malaria. It will determine whether     arginine can increase NO production and have an effect on NO-dependent physiological     measurements. The hypothesis is that arginine: will be safe in falciparum malaria; will     return plasma arginine concentration to normal/supranormal levels; will increase systemic and     exhaled NO; reduces oxidant stress; and improves a number of NO-dependent physiological     measures of relevance to malaria.   "
176665|NCT00147381|"     The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is     more effective in the prevention of renal graft rejection (considering an acute rejection     rate of 5% for Campath-1H/Tacrolimus and of 22% for Tacrolimus/MMF/Steroids).   "
176666|NCT00147394|"     The purpose of this research is to study the pharmacokinetics of risperidone in a group of     pediatric patients with Pervasive Developmental Disorder (PDD). The study will determine how     much risperidone and its breakdown product, 9-hydroxy-risperidone, is in the blood following     the patient's usual daily dose. The study is designed to look at how fast children absorb,     breakdown, and eliminate risperidone.   "
176667|NCT00147420|"     Previous research has confirmed that hemorrhage is among the most commonly encountered     pregnancy complications in the Tibet Autonomous Region (TAR). This trial will test the     effectiveness of a traditional Tibetan drug (Zhi Byed 11) vs. misoprostol to prevent     postpartum hemorrhage (PPH) among women delivering vaginally in three hospitals in Lhasa,     TAR.   "
176668|NCT00147433|"     This study is designed to test the hypothesis that the level of the thyroid hormone thyroxine     (specifically, free thyroxine, FT4) circulating in the blood of pregnant women is the key     thyroid-related factor to influence early fetal brain development. The investigators will     recruit 5000 pregnant women with clinically normal thyroid function (normal thyroid     stimulating hormone levels) in the second trimester. After the baby has been born, the     investigators will measure FT4 in the second trimester maternal blood sample to identify 100     cases (very low FT4 levels) and 100 matched controls (normal FT4 levels). The children of     cases and controls will undergo neurodevelopmental testing at 2 years of age to determine     whether IQ differs according to maternal FT4 levels during pregnancy. The potential impact of     the study is that if such an effect is found, it might be possible to avoid these adverse     developmental consequences in children by designing and testing strategies to identify and     treat high risk women.   "
176669|NCT00147446|"     There is a growing body of literature showing that stressful life events can increase the     risk of developing exacerbations and new brain lesions among people with multiple sclerosis.     The purpose of this study is to examine the hypothesis that stress management programs can     reduce the occurrence of new brain lesions and exacerbations. We will also examine potential     immune and neuroendocrine pathways.   "
176670|NCT00147459|"     Aim/Background: This study aims to investigate the necessity and efficacy of a hepatitis B     virus (HBV) vaccine booster in children after liver transplantation. A universal mass     vaccination program of HBV was launched for 20 years in Taiwan. The coverage rate is high and     the effect is great. The carrier rate of the population under vaccine coverage decreased from     10-15% to < 1%. In Taiwan, most children who receive organ transplantation were vaccinated     with HBV vaccine in infancy and well before the transplantation procedure. This vaccination     background information on Taiwanese children is quite unique and not similar to the other     countries in the world. The antibody generated by the vaccine usually wanes after a certain     period even in normal subjects, let alone in subjects who receive organ transplantation and     immunosuppressive agents after transplantation. At present, Taiwan is still an HBV     hyperendemic area and the risk of exposure to HBV cannot be overlooked. Should children be     given a booster dose of HBV vaccine after transplantation? And how about the immunogenicity     of this booster dose in these immunocompromised hosts? If these children cannot obtain an     adequate antibody titer, will the risk of HBV infection increase? This study is designed to     answer these questions. As a pediatric hepatologist, the author's routine work is to take     care of children who underwent liver transplantation. To take advantage of this, the     investigators decided to study the efficacy and necessity of HBV booster vaccine in these     patients. However, the results of this study should be able to be applied to any kind of     solid organ transplanted patients.      Method: The anti-hepatitis B surface antigen (HBs) titer will be checked in patients who     received liver transplantation > 1 year ago. If the titer is < 10 IU/L, a booster dose will     be administered. The humoral (anti-HBs) and cellular immunity (by ELISPOT to assay T and B     cell specific proliferation) and cytokine assay will be done in these patients before and     after the booster dose. A three-year follow-up will be performed to monitor the HBV infection     in these patients.      Expected Results: The investigators expect for those who survive one year more after liver     transplantation to yield a relatively good response to HBV booster under adequate     immunosuppression.   "
176671|NCT00147472|"     The purpose of this trial is to determine the ability of positron emission tomography (PET)     to detect residual cancer in neck lymph nodes of patients following curative treatment with     radiation therapy for squamous cell cancer arising in the head and neck.      Patients with head and neck cancer (HNC) undergo treatment of curative intent; patients who     are node positive (N2 N3 stages) undergo standard management which includes post-radiation     planned neck dissection but two thirds of patients end up not having evidence of residual     disease in neck dissection specimens; these patients could have avoided surgery. However,     currently used standard tests, like computed tomography (CT) and/or magnetic resonance     imaging (MRI) cannot reliably predict who is post-radiation disease free.   "
176672|NCT00147485|"     AG-024322 may work in cancer by stopping cancer cells from multiplying. AG-024322 is and     intravenous drug from a new class of drugs call cyclin-dependent kinase (CDK inhibitors).     This research study is the first time that AG-024322 will be given to people.   "
176673|NCT00147498|"     The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550     monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6     weeks for the treatment of the signs and symptoms of subjects with active rheumatoid     arthritis (RA).   "
176674|NCT00147511|"     To assess the onset of action of linezolid   "
176715|NCT00148057|"     This randomized controlled trial tests the hypothesis that a reduction in intake of dietary     fat will reduce the incidence of breast cancer. Women with more than 50% of the breast     occupied by dense tissue on a mammogram have been recruited and allocated by a random (ie     chance) process, to an intervention or control group. The intervention group has been taught     how to reduce their fat intake to a target of 15% of total calories, while the control group     continued their usual consumption of fat. Both groups have then been followed for at least 7     years and the number who develop breast cancer in each group will be compared   "
176754|NCT00148564|"     The purpose of this study is to evaluate the effects of different atypical antipsychotics on     weight changes, energy homeostasis, metabolism, energy intake as well as activity.      Patients with schizophrenia or schizoaffective disorders will be randomly assigned to be     treated with ziprasidone or olanzapine for 24 weeks.      Primary outcome parameter are the weight changes after 24 weeks.   "
176675|NCT00147524|"     ACE inhibitors are thought to modify the endothelium in a number of ways. Quinapril is an     effective and well-tolerated ACE-I for the treatment of patients with hypertension and     congestive heart failure. Quinapril produces favourable haemodynamic changes and improves     ventricular and endothelial function in patients with various cardiovascular disorders. These     effects are mediated through the binding of quinaprilat to both tissue and plasma-ACE.      Quinapril 10 to 40 mg once daily improved endothelial function (as measured by improved FMD     or reduced vasoconstrictive/increased vasodilative response to Ach) in patients with CAD and     hypertension over 2 to 6 months of therapy; improved endothelial function was also observed     in patients with CHF receiving a single infusion of quinaprilat. In general, quinapril showed     neutral or beneficial effects on lipid profiles, glycaemia and renal haemodynamics. (3) There     are no data available considering effects of quinapril on endothelial dysfunction in post-     menopausal woman with mild to moderate hypertension and with pathological endothelial     function.   "
176676|NCT00147537|"     Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of     recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin     Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when     administered with paclitaxel, carboplatin and erlotinib.      Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the     treatment of advanced non-small cell lung cancer   "
176677|NCT00147550|"     MEK is a critical member of the MAPK pathway involved in growth and survival of cancer cells.     PD-325901 is a new drug designed to block this pathway and kill cancer cells. The purpose of     this study is to study the effectiveness of PD-325901 in patients with colon cancer, breast     cancer, and melanoma. PD-325901 will be given by mouth as a pill twice a day, CT scans will     be done and biopsies will be taken of a tumor before and once during treatment to measure the     effects of the drug. Blood samples will be taken to measure the amount of drug in the blood.   "
176678|NCT00147563|"     To investigate the impact of antihypertensive therapy with the selective mineralocorticoid     receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect     of equivalent blood pressure control achieved with a b-blocker, atenolol.   "
176679|NCT00147576|"     Test the hypothesis that increasing doses of CP-866,087 will decrease the total number of     drinks consumed during a 2 hour acute alcohol consumption assessment and to determine the     safety and tolerability of multiple doses of CP-866,087 in alcohol dependent subjects     compared to placebo.   "
176680|NCT00147589|"     To evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children     aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and     about 320 patients will participate.   "
176681|NCT00147602|"     To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a     previous stroke or transient ischemic attack.   "
176682|NCT00147615|"     To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16     years with high blood pressure. The study will last at least 1 year and about 140 patients     will participate.   "
176683|NCT00147628|"     To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction     in men with ED as well as to validate the new Sexual Experience Questionnaire which     incorporates functional and emotional elements of a man's sexual experience into one     comprehensive questionnaire.   "
176684|NCT00147654|"     The primary objective of the trial is to evaluate the effect of tolterodine ER plus     tamsulosin versus placebo on patient perception of overall treatment benefit in men who have     frequency and urgency, with or without urinary urge incontinence (UUI), with or without     bladder outlet obstruction (BOO).   "
176685|NCT00147667|"     The purpose of this study is to determine whether long term treatment with oral erythromycin     is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD)     by reducing the number of exacerbations and the degree of airway inflammation.   "
176686|NCT00147680|"     This study will be an open, non-randomised, clinical phase 2 trial, which will involve 30     women diagnosed with uterine papillary serous cancer. The researchers will investigate the     effect of four cycles of paclitaxel/carboplatin, followed by whole pelvic external beam     radiotherapy to a standard pelvis field (50.4 Gy) with or without a para-aortic boost with     respect to the safety and efficacy of treatment, and patterns of recurrence.   "
176687|NCT00147693|"     The objective is to ascertain the potential efficiency of a systematic care programme for     caregivers of dementia patients. The research questions are:        -  What are the costs and benefits of the Systematic Care Programme - Dementia          (SCP-Dementia), as compared with usual care?        -  What are the effects on the quality of life of patients and informal caregivers (spouse,          relative), as compared with usual care?   "
176688|NCT00147706|"     The purpose of this study is to determine if patients with congestive heart failure, diabetes     or secondary cardiovascular diseases, who access HealthMedia's online tailored behavior     change programs on the electronic health record patient portal have better clinical and     behavioral change outcomes.   "
176689|NCT00147719|"     The purpose of the study is to see how safe and effective and tolerable the use of     colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in     combination with other anti-diabetic drugs.   "
176706|NCT00147940|"     The purpose of our study is to correlate nasal volume and cross-sectional area with nasalance     scores. We will measure nasal volume and cross-sectional area with acoustic rhinometry.     Nasalance scores will be determined by Nasometry.      Acoustic rhinometry is a means to study the volume and cross-sectional areas of the nasal     cavity in a non-invasive, rapid, convenient and reliable manner. Acoustic rhinometry has the     unique advantage of being completely non-invasive, and thus is able to measure nasal patency     without the confounding effects of probes or invasive monitoring.      Nasometry is a technique to measure the oral and nasal components of nasalance. Nasalance is     the objective measure of the nasal component of speech that is determined by the ratio of     sound pressure emitted from the nasal and oral cavities during speech. Nasality is the term     used to characterize the nasal component of speech, and is a subjective measure.      Eleven healthy subjects underwent acoustic rhinometry pre and post decongestion using     oxymetazoline 0.05% nasal spray. Nasalance scores were based on the readings of three     passages: rainbow, zoo, and nasal.   "
176690|NCT00147732|"     TITLE:      A multicentre, randomised, phase III clinical trial comparing accelerated radiotherapy with     accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in clinical stage T2-4     laryngeal carcinoma.      PRIMARY OBJECTIVE:      Does the addition of carbogen and nicotinamide to a schedule of accelerated radiotherapy in     patients with clinical stage T2-4 laryngeal carcinoma improve local primary tumour control?     Definitive analysis will be performed on local control rates at two years after completion of     radiotherapy.      SECONDARY OBJECTIVES:      Does the addition of carbogen and nicotinamide        -  increase the larynx preservation rate?        -  increase the regional control rate?        -  increase the toxicity of accelerated radiotherapy?        -  improve the overall quality of life?        -  improve the disease-free survival?        -  improve the overall survival?      STUDY DESIGN:      An open-label, randomised clinical trial assigning patients in a 1:1 ratio to one of the     following treatment arms:        -  accelerated radiotherapy        -  accelerated radiotherapy plus carbogen and nicotinamide      PATIENT CHARACTERISTICS AND NUMBER:      344 patients with clinical T2-4 laryngeal carcinoma      MEASUREMENTS:        -  time to local failure        -  time to regional failure        -  survival with functional larynx        -  overall and disease-free survival        -  frequency and severity of complications related to radiotherapy and carbogen and          nicotinamide        -  quality of life assessment   "
176691|NCT00147745|"     This study is designed to assess the potential mechanism of action by which WelChol®     (colesevelam) may improve blood glucose control in patients with type 2 diabetes   "
176692|NCT00147758|"     The purpose of the study is to see how safe and effective and tolerable the use of     colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in     combination with other anti-diabetic drugs.   "
176693|NCT00147771|"     Morphea is very hard to treat. In a small number of adult patients, Imiquimod has proven to     be beneficial in decreasing the thickness of the morphea plaques , while improving their     appearance. There are no studies to date proving its safety and efficacy in children with     this disease. We propose to conduct a pilot study to assess to potential efficacy and     relative safety of Imiquimod in children with plaque morphea.   "
176694|NCT00147784|"     -  To evaluate if weekly psychological follow-up make opioid dependent patients in MMT able          to accomplish 14 weeks treatment with Peginterferon alfa-2a (PEG-INF) and ribavirin to          the same extent than non-opioid dependents.        -  To determine the efficacy of this anti-HCV treatment   "
176695|NCT00147797|"     The advent of new antiretroviral agents, in particular Highly Active Antiretroviral Therapy     (HAART), spectacularly reduced HIV-associated morbidity and mortality. However, new     complications have appeared in HIV-infected patients treated by with HAART such as     dyslipidemia, insulin resistance, diabetes mellitus, and related cardiovascular complications     including acute coronary syndromes, peripheral vascular disease, and stroke have been     reported.      A linear association has been proved between increased intima-media thickness of the common     carotid artery (CCA-IMT), aortic stiffness (pulse wave velocity [aPWV]) and incidence of     cardiovascular events suggesting that IMT and aPWV could be considered as an early marker of     atherosclerosis. The progression of IMT has been shown to be predictive of cardiovascular     events. Case control and longitudinal studies but not all have suggested an increase CCA-IMT     in HIV-infected patients under HAART compared with non-HIV infected patients with different     progression.      The aim of this study was to examine the effects of pravastatin on CCA-IMT and aortic     stiffness in dyslipidemic HIV-infected patients receiving HAART by using a high-resolution     echotracking system.      Patients in the pravastatin group were consecutively recruited in four department of     infectious diseases if they fulfilled the following criteria : (1) HIV-infected treated with     HAART for > 12 months 2) with dyslipidemia, defined as fasting serum LDL cholesterol > 160     mg/dL before initiation of pravastatin, (3) treated with pravastatin > 12 months and one more     coronary risk factor. The patients in the control group were selected consecutively in the     same departments among 1) HIV-infected patients treated with HAART > 12 months 2) fasting     serum LDL cholesterol > 160 mg/dL 3) without lipid-lowering drugs and one more coronary risk     factor. Cases and control patients were matched for age, gender and tobacco consumption.      Using data from Mercie et al., inclusion of 42 patients in pravastatin and control groups was     the minimum sample size needed for detection of a 6.5% difference in CCA-IMT, in a two-sided     test (a = 0.05, b = 0.20).      The protocol of the study, sponsored by the French Society of Cardiology was approved by the     Committee for the Protection of Human Subjects in Biomedical Research of Pitié-Salpétrière     University hospital in Paris. Written informed consent to participate in the study was     obtained from each patient.   "
176696|NCT00147810|"     1. To determine if there are gender differences in asthma prevalence, severity, treatment,          and health care utilization within patient populations in Kaiser Permanente Northwest          and Colorado Regions.        2. To test the ability of an automated telephone outreach intervention to reduce health          care utilization for acute asthma exacerbations and improve quality of life. The          intervention used speech recognition technology to gather information about current          asthma control, patterns of medication use, and recent acute health care utilization for          asthma. This information allowed the intervention to provide tailored educational          feedback and to flag patients deemed to be at high risk for future exacerbations so that          they could be followed up by the health care system.   "
176697|NCT00147823|"     This is a prospective randomized study comparing Vitoss alone versus Vitoss with bone marrow     aspirate in benign bone lesions.   "
176698|NCT00147836|"     The purpose of this study is to investigate and evaluate the effects of different     interventions (1.continuous subcutaneous insulin infusion,2.multiple daily injections,     3.anti-hyperglycemic agents) on glycemic control, B-cell function and the remission rate in     newly-diagnosed type 2 diabetic patients.   "
176699|NCT00147849|"     The purpose of this study is to identify, from a societal perspective, the costs and     associated benefits of three strategies for disseminating and implementing a practice     guideline that addresses the management of croup.   "
176700|NCT00147862|"     To Study whether infusion of Tranexamic Acid (a synthetic antifibrinolytic agent) reduces     blood loss during head and neck surgery.   "
176701|NCT00147875|"     The objectives of this study are to assess the feasibility and efficacy of a combination     chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.   "
176702|NCT00147888|"     To study nasal physiologic responses to changes in posture, temperatures, humidity and nasal     patency with acoustic rhinometry.   "
176703|NCT00147901|"     This study aims to assess the short term efficacy of a combination immunochemotherapy in     patients with relapsed B-cell chronic lymphatic leukemia.   "
176704|NCT00147914|"     This study is a comparison between two commonly used antibiotics (Cefdinir vs.     Amoxicillin/Clavulanate) in patients with acute sinus infection, surveying quality of life.     The hypothesis is that the two treatments would be at the least equivalent based on clinical     outcome measures of improvement in quality of life.   "
176707|NCT00147953|"     This study aims to assess the short term efficacy of a combination of rituximab and low-dose     radiotherapy in patients with non-Hodgkin's lymphoma.   "
176716|NCT00148070|"     This is a research study which aims to improve the way that doctors determine the dose of     chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height     and weight. However, some patients metabolize chemotherapy faster or slower than the average     person because of a different level of drug metabolizing enzyme in the liver. Therefore, some     patients are either given too small or too large a dose of chemotherapy because the amount of     enzyme is not taken into account. This research study will examine the use of a simple test,     call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can     metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored     to the amount of enzyme which is available to metabolize the drug for each patient.   "
176717|NCT00148083|"     The specific aim of this study is to determine whether the new, long-acting, form of     risperidone, Risperdal Consta, improves the ability of schizophrenia patients to benefit from     skills training. The hypothesis guiding this study is that Risperdal Consta, by improving     verbal memory, will improve the ability to benefit from skills training interventions among     schizophrenia patients. The primary objective of this study is to compare patients on     Risperdal Consta to patients on other atypical antipsychotic medications in terms of their     ability to benefit from skills training interventions. A secondary objective of this study is     to determine whether patients taking Risperdal Consta improve in other areas of cognitive     functioning and social functioning.   "
176718|NCT00148096|"     Asthma has become increasingly common in the UK, demanding our consideration of the cause.     Many patients with asthma are allergic to house dust mites, which thrive in modern housing.     Improving ventilation in the home has been shown to reduce dust mite levels, by reducing     humidity levels. It is hoped that, by removing the dust mites from homes, asthma may improve.     In this study, 140 volunteers will have their carpets steam-cleaned and new allergy bedding     provided, before a team of architects installs a ventilation system in the loft. Half of the     units will be switched on at the beginning of the study. The other half will be switched on     in 12 months time, but only the architects know which units are active. The medical team will     compare the asthma, and measures of inflammation in the airways, over that year.      It is due for completion in April 2007.   "
176719|NCT00148109|"     The purpose of this study is to explore how this cancer is affected by a new medication,     cetuximab. Cetuximab is directed towards a protein called EGFR (epidermal growth factor     receptor), that is found in some types of cancer. Studies have shown that this drug can be     beneficial in patients with colon cancer and has been approved by the US Food and Drug     Administration (FDA) for this purpose. The researchers are conducting a study to see if it is     beneficial in patients with sarcoma.   "
176720|NCT00148122|"     The purpose of this study is to determine the effectiveness and side effects of a new     combination and schedule of chemotherapy drugs in the treatment of head and neck cancer.     Patients with advanced or recurrent head and neck cancer, which is untreatable by surgery or     radiation therapy are eligible for this study. Standard treatment for advanced or recurrent     head and neck cancer involves the use of chemotherapy.   "
176721|NCT00148135|"     This study is for patients with a type of cancer called carcinoma of unknown primary site     (CUP), meaning that the site of the body where the tumor has originated is not clear.     Currently, carcinoma of unknown primary site (CUP) accounts for about 5% of all newly     diagnosed malignancies. The stage of the tumor is such that it is not treatable by surgery.     Currently, the standard treatment for such a type of cancer at that stage is chemotherapy.     However, the overall prognosis for patients with metastatic CUP remains poor, even if treated     with conventional chemotherapy. Through ongoing research at medical centers around the world,     doctors are trying to improve on the presently available chemotherapy regimens. The purpose     of the investigators' study is similar: it is trying to determine whether a combination of     three chemotherapy drugs - carboplatin, gemcitabine, and capecitabine - will improve the     treatment of patients with metastatic CUP. The reason the investigators are interested in the     above combination of chemotherapy agents is that each one of them is already used in patients     with a variety of specific tumors, such as lung cancer, breast cancer, pancreatic cancer,     colon cancer, etc.      This research study will help determine whether the combination of carboplatin, gemcitabine     and capecitabine can be used and is effective in patients with carcinoma of unknown primary     site.   "
176722|NCT00148148|"     The study compares the safety, efficacy and pharmacokinetics of caspofungin, liposomal     amphotericin B or the combination of both in the antifungal treatment of adult patients after     allogeneic haematopoietic stem-cell transplantation with granulocytopenia and persistent i.g.     recurrent fever under adequate antibacterial therapy.   "
176723|NCT00148161|"     The goal of the study is to examine the cortical activity during speech perception and speech     production in idiopathic stutterers compared to fluent speakers. Therefore, the noninvasive     method of magnetoencephalography (MEG) is used. A better understanding for the complexity of     speech perception and its pathology should be developed.      Fundamental properties of stuttering are repetitions, prolongations, and blocks. In most     cases stuttering emerges between 2 and 5 years of age. The auditory feedback should become     less important during development, as soon as information about mispronounced words does not     occur anymore. During speech development this control function should be adopted by other     systems. In stutterers the dominance of the acoustic control should remain.      Brain imaging studies with positron emission tomography (PET) or magnetic resonance imaging     (MRI) show defects in the network of motor system, in the lateralization of speech areas, and     functions of the auditory cortex. Magnetoencephalographic studies describe a similar variety     as cause of stuttering. There may be defects in the auditory feedback, a modification of the     lateralization of speech areas, or an alteration of co-action of motor planning and auditory     system.      The benefit of magnetoencephalography is a very good temporal resolution in the range of     milliseconds combined with good spatial resolution. Therefore, it is well suited to examine     the dynamics of cortical processing during stuttering. In this study evoked components of the     auditory systems related to complex sounds, vocals, consonant-vocal combinations, and single     words are analyzed. Differences of these components in the auditory cortices of stutterers     and fluent speakers are hypothesized as well in temporal structure as in localization and     lateralization.   "
176753|NCT00148551|"     A 24 - month Study looking at the the changes in visual acuity of patients receiving PDT     therapy in conjunction with intravitreal triamcinolone.   "
176724|NCT00148174|"     This is a randomized controlled intervention trial in poorly compliant patients, testing     whether improved compliance behavior decreases rates of acute rejection risk and graft loss.      Hypothesis: A study of an intensive intervention focused on the least compliant patients and     beginning 3 months post-transplant. Effective intervention will reduce the number of acute     rejection episodes and thus the occurrence of chronic rejection and graft loss.   "
176725|NCT00148187|"     The purpose of this study is to quantitate pre-transplant medication compliance, dialysis     compliance, and related psychological variables, and then examine their validity as     predictors of post-transplant noncompliant behaviors and clinically relevant outcomes (acute     rejection, graft loss, or death).      Hypothesis: Noncompliance with pre-transplant medication or with the dialysis prescription,     and specific psychological variables predict similarly noncompliant behaviors after     transplantation.   "
176726|NCT00148200|"     Purposes of this study are:        -  To determine the prevalence of female sexual dysfunctions among Italian general          population        -  To determine which sexual domains are more frequently compromised        -  To evaluate which of the factors we took into consideration are more frequently          associated with FSD   "
176727|NCT00148213|"     Human thyroglobulin (Tg) is the most sensitive biochemical marker for recurrence of     differentiated cancer (DTC), especially after the complete removal of thyroid tissue through     surgery and radioiodine therapy (RIT).      Unfortunately, current assays for measuring Tg in blood samples are not sensitive enough to     reliably measure Tg while patients are under thyroid hormone replacement therapy. Instead     patients have to withdraw thyroid hormone for several weeks or receive costly injections of     recombinant thyroid stimulating hormone (TSH) in order to raise Tg production by thyroid     remnant and/or thyroid cancer cells so that it can be measured by current Tg assays. Other     patients have antibodies against Tg that interfere in current immunoassays.      The purpose of the study was to characterize a new highly sensitive assay for measuring Tg in     the serum in thyroid cancer patients both on thyroid hormone therapy and off therapy in     comparison to the normal routine assay already in use at Münster University Hospital.   "
176728|NCT00148226|"     This project has been completed and consisted of a randomised trial of six tailored decision     aids giving patients evidence-based information about faecal occult blood test screening for     bowel cancer. 314 Australians aged between 50-74 years were recruited from five general     practices and randomised to received either the tailored decision aid with age-gender and     family history specific information and values clarification exercise or a standard     government information sheet.      The decision aid significantly increased the proportion of people who were informed     participants in the screening program.   "
176729|NCT00148239|"     The overall objective of this project is to test the efficacy of an innovative     multi-component intervention aimed at reducing the risk for adverse health outcomes among     caregivers of older survivors with spinal cord injury or disability, and to improve the well     being of the spinal cord-injured survivor. In a three-group, randomized, controlled design     providing access to information, resources, and support, we predict that the dual target     approach will have a greater positive impact on both the caregiver and survivor than the     caregiver-only approach, and that both active treatments will be superior with respect to     caregiver outcomes than an information-only control condition.   "
176730|NCT00148252|"     To compare the change in renal function between CsA or MMF withdrawal from before to 12     months after drug withdrawal in renal transplant recipients on triple immunosuppressive     therapy   "
176731|NCT00148265|"     This study is likely to identify an improved and economical treatment for diabetic macular     oedema, one of the commonest causes of blindness both in Australia and the rest of the     world.The specific aims of the study are to test the following hypotheses:        -  That intravitreal triamcinolone followed by laser treatment results in a greater          improvement in visual acuity than placebo followed by laser treatment of eyes with          macular oedema secondary to diabetes;        -  That intravitreal triamcinolone followed by laser treatment results in greater degree of          resolution of macular oedema than placebo followed by laser treatment of eyes with          macular oedema secondary to diabetes;        -  That intravitreal triamcinolone followed by laser treatment results in a reduced          requirement for further laser treatment to control diabetic macular oedema than placebo          followed by laser treatment;        -  That intravitreal triamcinolone followed laser has a manageable and acceptable safety          profile in eyes with diabetic macular edema.   "
176732|NCT00148278|"     Catecholamines infusion is a major component of septic shock management. International     guidelines recommend that norepinephrine should be preferred to epinephrine, though phase III     trials are lacking. The present study aimed at comparing the efficacy and safety of     norepinephrine plus dobutamine to that of epinephrine in adults with septic shock.   "
176733|NCT00148291|"     Vinorelbine is currently the standard treatment for elderly patients with advanced non-small     cell lung cancer (NSCLC). Docetaxel has also shown promising results against elderly patients     in phase II studies. We conducted a randomized phase III trial to evaluate whether docetaxel     provided better overall survival than vinorelbine in elderly patients with advanced NSCLC.   "
176734|NCT00148304|"     The purpose of this study is to better understand disparities in insulin dosing, hemoglobin     A1c, and self-reported patient self-care behaviors among non-Hispanic white, Hispanic, and     African American veterans with type 2 diabetes receiving VA care.   "
176735|NCT00148317|"     PRIMARY STUDY OBJECTIVES        -  To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and          without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different          subsets of multiple myeloma patients:             1. Patients post first line therapy             2. Patients with relapsed/refractory disease who are bortezomib-naïve        -  To evaluate the safety of the combination of bortezomib and dexamethasone, with and          without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with          multiple myeloma.      SECONDARY STUDY OBJECTIVES        -  To evaluate the role of the combination of bortezomib dexamethasone, with and without          DOXIL, followed by high-dose cyclophosphamide on the ability to collect > 10 x 106 CD34+          cells/kg in < 7 collections (for both subsets of multiple myeloma patients).        -  To evaluate the survival of patients who receive the combination of bortezomib          dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both          subsets of patients).   "
176736|NCT00148330|"     This open label extension will treat all the eyes of study participants with active study     medication (intravitreal triamcinolone) as well as standard laser treatment where     appropriate.      The specific aims will be to test the following hypotheses:        -  That intravitreal triamcinolone for diabetic macular oedema that persists or recurs          after laser treatment remains efficacious over five years        -  That intravitreal triamcinolone for diabetic macular oedema that persists or recurs          after laser treatment retains a manageable and acceptable safety profile over five years   "
176737|NCT00148343|"     The objective of this research is to determine if electrical stimulation can improve the     strength and coordination of the lower limb muscles, and the walking ability of stroke     survivors.      The knowledge gained from this study may lead to enhancements in the quality of life of     stroke survivors by improving their neurological recovery and mobility. The results may lead     to substantial changes in the standard of care for the treatment of lower limb hemiparesis     after stroke.   "
176738|NCT00148356|"     The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx     drug-eluting stent in patients with blockage of native coronary arteries. The study is     designed to demonstrate non-inferiority to the TAXUS Express2 Paclitaxel-Eluting Stent that     has proven superior to bare metal stents and is a recognized standard of care.   "
176739|NCT00148369|"     The primary purpose of this study is to evaluate clinical and serologic outcomes after the     discontinuation of liatermin therapy as assessed by development of new clinical conditions     beyond those expected in patients with advancing Parkinson's disease. In addition, the     development or resolution of anti-r-metHuGDNF binding and neutralizing antibodies will be     monitored.   "
176740|NCT00148382|"     The purpose of this study is to investigate the amount of metabolites of ATL-962 in the blood     and to investigate the effect of ATL-962 on the amount of fat that is excreted in the faeces     in subjects who are obese   "
176741|NCT00148395|"     This study wants to assess different intensive therapy sequences for the treatment of     non-small-cell lung cancer.      It claims less on the efficacy of different chemotherapy combinations, than more on the     comparison of different strategies of sequential single-agent, sequential double-agent or     sequential triple-agent therapy.   "
176742|NCT00148408|"     The purpose of this research study is to investigate the way that educational approaches and     presentation of a drug may affect the response to montelukast and placebo (an inactive     medication) in subjects with asthma.   "
176743|NCT00148421|"     Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle     chemotherapy.   "
176744|NCT00148434|"     While patient held guidelines for the management of chronic diseases have been employed in     some countries. There is little evidence of their effectiveness in improving patient     outcomes. We hypothesised that a patient held guideline on the management of hypertension     combined with a specific exhortation to patients to challenge their medical care where the     guidelines did not appear to have been applied would improve blood pressure control, lower     average blood pressure, lower average cholesterol, increase the appropriate use of statins     and aspirin, and have no impact on patient anxiety. Patients were randomised to the guideline     or to standard hypertension information. Measures of anxiety were taken at baseline 2 weeks     and one year, blood pressure and cholesterol was measured at one year and case notes examined     to determine appropriate statin and aspirin usage.   "
176745|NCT00148447|"     The aim of this study is to evaluate the therapeutic effect of escitalopram in the treatment     of negative symptoms in schizophrenia patients in a double-blind placebo-controlled study.   "
176746|NCT00148460|"     The objective of this trial was to compare the efficacy and safety of a single bolus of     TNK-tPA (tenecteplase, Metalyse®) compared with rt-PA (alteplase, Actilyse®) in Asian     patients.   "
176747|NCT00148473|"     The purpose of this study is to compare the efficacy between a single dose of oral     misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor.   "
176748|NCT00148486|"     To demonstrate efficacy and dose-response of NS 2330 versus placebo in patients with early     Parkinson's Disease in 14 weeks of treatment, and to investigate the safety and tolerability     of NS 2330 in these patients.   "
176749|NCT00148499|"     The purpose of this trial is to investigate efficacy and tolerability of lozenges containing     20 mg a mbroxol hydrochloride (Mucoangin?) relative to lozenges containing placebo and     lozenges containing 3 mg benzocaine in relieving pain of sore throat in patients suffering     from acute viral pharyngitis.   "
176750|NCT00148512|"     The primary objective of this exploratory study is to investigate the efficacy and safety of     tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week     treatment period in levodopa treated Parkinson patients with motor fluctuations.   "
176751|NCT00148525|"     The purpose of this study is to test two different approaches to helping individuals who have     recently starting eating a healthful diet maintain those healthy changes. This study will     deliver a health program using an automated telephone system. The programs will be designed     to help individuals maintain a healthy diet change for a lifetime.   "
176752|NCT00148538|"     This is a randomized controlled trial evaluating different exercise modalities in previously     inactive subjects with type 1 diabetes.      The primary objective of this study is to determine the effects of resistance exercise     training, and of aerobic exercise training, on glycemic control (A1c) in previously inactive     individuals with type 1 diabetes, with background therapy meeting modern standards, including     multiple daily insulin injections or insulin pump, carbohydrate counting, frequent glucose     monitoring, and utilization of glucose monitoring to adjust CHO and insulin for exercise.      Secondary aims: In type 1 diabetic individuals receiving therapy meeting the criteria above,     to determine the effects of resistance exercise training and aerobic exercise training on     frequency of hypoglycemia, body composition, lipids, C-reactive protein and quality of life.      Hypotheses:        1. Subjects randomized to resistance exercise (R and AR combined) will have greater          reductions in A1c than in those not randomized to resistance exercise (A and C          combined).        2. Subjects randomized to aerobic exercise (A and AR combined) will show a trend to greater          HbA1c reduction than those not randomized to aerobic exercise (R and C combined).      Secondary hypotheses: We expect that both aerobic and resistance exercise will show trends to     improvement in most listed secondary outcomes.   "
176757|NCT00148603|"     This is a single site study of the effect of montelukast on eosinophil and mast cell counts     and activation in the lining of the duodenum in 24 children with dyspepsia in association     with duodenal eosinophilia in association with measuring the concentration of the medication     in the lining of the duodenum. Patients will be endoscoped with biopsies obtained from the     duodenum as part of routine clinical care. Participants in the study will then receive     montelukast daily and the endoscopy with biopsies will be repeated on day 21 to measure cell     counts and activation and tissue montelukast levels. Cell counts and measures of activation     will be compared to pre-treatment levels.   "
176758|NCT00148616|"     The purpose of this study is to evaluate the efficacy and safety of memantine as add-on     treatment for the treatment of negative symptomatology and cognitive impairment in patients     with chronic schizophrenia.      Primary outcome parameter are changes in negative symptoms between baseline and 6 months   "
176759|NCT00148629|"     The purpose of this research is to compare the efficacy of two low-cost low intervention     packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two     packages are Standard of Care as described by the WHO (presumptive treatment for malaria and     helminths plus daily iron + folic acid supplements) and Enhanced Care (Standard of Care plus     daily multivitamins and a 2nd dose of anthelminthic.)   "
176760|NCT00148642|"     The purpose of this study is to determine if the use of a silver-coated endotracheal tube     (ETT) can reduce the incidence and/or delay the time of onset of VAP when compared to a non     silver-coated ETT in patients who have been mechanically ventilated for >= 24 hours.   "
176761|NCT00148655|"     The purpose of this study is to determine whether adding an educational intervention, in the     form of a decision board, which outlines the risks and benefits of treatment options for     DCIS, at the time of the first surgical consultation will improve decision making for women     with DCIS.   "
176762|NCT00148668|"     The purpose of this study is to find out what effects the preoperative combination therapies     of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early     stage HER-2 positive breast cancer.   "
176763|NCT00148681|"     The purpose of this study is to find out what effects the preoperative combination therapy of     herceptin and navelbine have on HER-2 positive breast cancer.   "
176764|NCT00148694|"     The purpose of this study is to find out what effects the preoperative therapy cisplatin will     have on patients with early stage estrogen receptor-negative (ER-), progesterone     receptor-negative (PR-), or HER-2 negative breast cancer.   "
176765|NCT00148707|"     The purpose of this study is to collect information on what effects (good or bad) CT-2103     (Xyotax) has on breast cancer as well as any side effects the drug may cause.   "
176766|NCT00148720|"     The purpose of this study is to find out what effects (good and bad) taking capecitabine for     12 weeks before surgery will have on women with breast cancer.   "
176767|NCT00148733|"     The aim of the study described is to measure the degree with which zinc given as adjunct     therapy to standard antibiotic treatment during childhood pneumonia reduces the risk of     treatment failure and the duration of the illness.   "
176768|NCT00148746|"     The study was designed to test the hypothesis whether a standardized, time-and score-oriented     treatment following a strict evidence based algorithm is equally effective to a standard     treatment regimen for moderate to severe atopic dermatitis.      Study Type: Mono-centre study, patients are blinded, physicians are randomized to either     treat study- or controll group      Eligible are patients age 2 years or older with SCORAD >= 20 Duration: 12 Months, study     visits every 4 weeks.      Primary endpoint is Difference between Baseline SCORAD and mean SCORAD under treatment.      Secundary endpoints are quality of life, safety and economic burden in both treatment groups.   "
176769|NCT00148759|"     The levels of lopinavir achieved in the blood following oral ingestion of standard doses of     Kaletra (lopinavir/ritonavir) in HIV-infected men was compared with those achieved in     HIV-infected women receiving the same dose of the drug.   "
176770|NCT00148772|"     The primary objective of this study is to evaluate the effect of erlotinib on the PSA     response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen     deprivation therapy.      The secondary objectives are to evaluate the effect of erlotinib on the duration of PSA     response, to evaluate the effect on the time to PSA progression, to evaluate the toxicity of     erlotinib in this patient population, and lastly, to correlate the effect of erlotinib with     various epidermal growth factor receptor (EGFR)-related proteins using baseline     immunohistochemical (IHC) studies on tissue blocks and peripheral blood mononuclear cells.   "
176771|NCT00148785|"     When individuals who are infected with HIV are started on treatment with HIV medications, the     effect of these drugs only lasts for a limited period of time, often because of development     of drug resistance by the HIV virus. When this happens, such patients have to be switched to     different combinations of HIV medications. However, since the availability of new HIV drugs     that are active against resistant virus is limited, HIV care providers are resorting to     curtail medications that contain three or more protease inhibitors (PIs). The reason for this     is Norvir (ritonavir), a PI that has the ability to boost or increase the blood levels of     other PIs in a way that can sometimes overcome the resistance of HIV virus. In addition, it     may be more difficult for the virus to overcome two or more drugs with high blood levels,     than it is to overcome just one. For these reasons, many clinicians are now using Norvir in     combination with two other PIs, including Crixivan (indinavir) plus Lexiva (fosamprenavir),     for treating patients who have been exposed to many other HIV medications.      While this may be the case, researchers also know that when two or more PIs are combined, the     effects each drug may have on the blood level of other drugs could be different. For example,     researchers know from some recent studies that the combination of Norvir, Lexiva, and     Kaletra, another PI, leads to an unacceptably low level of both Kaletra and Lexiva. Because     researchers can not always assume that when multiple HIV medications are combined, the levels     will remain high enough to be effective, the investigators think it will always be reasonable     that, before any combination of drugs are used on HIV-infected patients, the effect a     combination has on the levels of each of the drugs in the combination should be investigated.      AIMS: The aim of this pilot study therefore is to examine the blood levels of Crixivan,     Lexiva, and Norvir when these three drugs are used together as part of a combination     treatment for HIV infection.      METHODS: Fifteen (15) HIV-infected volunteers already being treated with a Crixivan and     Norvir containing regimen will be recruited from the Grady Infectious Disease Clinic (IDP).     Lexiva will be added to this regimen for 5 days, at the end of which participants will be     admitted to the Grady General Clinical Research Center (GCRC) where blood samples will be     collected at 9 different time points over 12 hours for measurement of blood drug levels.      Pharmacokinetic Analysis: The blood concentrations of Crixivan, Lexiva, and Norvir will be     measured by a special technique known as reverse-phase high-performance liquid chromatography     with ultraviolet detection.      Statistical Analysis: The blood level information will be summarized by a statistical method.     The researchers will then compare the levels of Lexiva in this combination with historically     published levels of Lexiva in a study of Lexiva plus Norvir; and that of Crixivan in a study     of Crixivan plus Norvir. A difference of 30% or more in drug levels between this study and     historical reports will be considered a significant difference.   "
176772|NCT00148798|"     The purpose of this trial is to investigate the efficacy of cetuximab in combination with     chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell     lung cancer who did not received prior chemotherapy. Overall survival will be taken as     primary measure of efficacy.   "
176776|NCT00148863|"     Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin. There is no     treatment recommended for non responders patients. This study will evaluate the efficacy,     after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the     addition of interferon gamma in non responders patients   "
176777|NCT00148876|"     This study is done in patients having Breast Cancer with metastasis (patients with positive     receptor HER2) whose disease progressed after receiving Trastuzumab.      The primary objective of this study is to compare the time until disease progression between     the Treatment Arm CAPECITABINE and the Treatment Arm CAPECITABINE + TRASTUZUMAB      The study has also other secondary and tertiary objectives.   "
176778|NCT00148889|"     The purpose of this study is to investigate the efficacy and safety of bilateral pallidal     stimulation in patients with medically refractory primary cervical dystonia.   "
176779|NCT00148902|"     This is a safety and tolerability study of GW572016 given with docetaxel (TAXOTERE).   "
176780|NCT00148915|"     The purpose of this randomized, double-blind, placebo-controlled study is to estimate the     effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality     and strength at the proximal femur at one year.   "
176781|NCT00148928|"     Patients with hormone-sensitive prostate cancer and rising PSA, after primary tumor     treatment, will be treated with the P501-AS15 vaccine as out-patients. The maximum dose will     be 16 vaccinations, given over a period of approximately one year. Thereafter, the patients'     long-term safety and PSA status will be followed over a period of approximately 11 months.   "
176782|NCT00148941|"     The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK     Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate     non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and     safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine     [Infanrix] and Aventis Pasteur's IPV vaccine [IPOL]) when administered as a 5th dose of DTaP     and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines     will be co-administered with the second dose of M-M-RII, which is recommended at this age.     Concomitant administration of a US-licensed influenza vaccine will be allowed according to     seasonal availability of vaccine and at the discretion of the investigator.   "
176783|NCT00148954|"     RIGHT is a randomized, prospective, two-arm study that will assess the differential efficacy     of VITALITY 2 implantable cardioverter defibrillators (ICDs) using Rhythm ID™ versus selected     Medtronic ICDs.   "
176784|NCT00148967|"     INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative     dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.   "
176785|NCT00148980|"     Normal bone marrow function depends on the coexistence of normal hematopoietic stem cells and     a microenvironment mostly located in the medullary part of the bones. Stem cells cannot     function properly in the absence of an adequate microenvironment. Whereas in malignant and     non-malignant hematologic diseases caused by a deficiency or abnormal stem cells, stem cell     transplantation is the treatment of choice that results in a cure, in diseases such as MDS,     myelofibrosis, and other conditions associated with an abnormal microenvironment,     pancytopenia may occur despite the presence of apparently normal hematopoietic cells with no     recognizable cytogenetic abnormality.      We, the investigators at Hadassah Medical Organization, proved in experimental studies that     the entire osteohematopoietic complex consisting of trabecular bone, hematopoietic     microenvironment (of stromal origin) and hematopoietic tissue has been successfully     transferred directly into ablated bone marrow cavity in a one-step transplantation procedure.      The goal of this study is to enhance hematopoiesis in patients with myelofibrosis syndrome by     intraosseous inoculation of demineralized bone matrix (DBM) together with allogeneic bone     marrow cells (BMC).   "
176786|NCT00148993|"     The goal of this study is to apply allogeneic tumor cell vaccination for immunotherapy in     patients with micro-metastatic disease and/or in patients at high risk disease progression.     The present study will use allogeneic tumor cell lines for tumor cell vaccines that share MHC     determinants with the patient aiming to overcome possible restriction of antigen     presentation.   "
176787|NCT00149006|"     The present protocol is designed to investigate the potential application of allogeneic     cell-mediated immunotherapy in metastatic solid tumors similarly to the well established     graft versus leukemia (GVL) effects in patients with hematologic malignancies.      Patients with metastatic solid tumors resistant to conventional modalities will be eligible     to participate in a treatment program based on the administration of non-myeloablative     immunotherapy (i.e. fludarabine, Cytoxan) followed by interferon injections; subsequently the     patients will be treated with mismatched alloreactive donor lymphocytes activated in vitro     and in vivo with rIL-2. The aim of this study is based on the recognition of foreign tumor     cell surface alloantigens.   "
176788|NCT00149019|"     Patients with resistant metastatic solid tumors failing all conventional modalities who are     eligible for immunotherapy by bispecific antibodies.      First step: NST Second step: Patients with tumor cells expressing positive Her-2Neu and/or     EpCAM with residual or recurrent disease following NST will be candidates for donor     lymphocytes immunotherapy using bispecific antibodies.      Patients with no matched donor available, expressing positive Her-2Neu and/or EpCAM tumor     cells, will be eligible for donor mismatched lymphocytes using in-vitro rIL-2 activated     allogeneic lymphocytes targeted to the tumor by bispecific antibodies, Her-2Neu and/or EpCAM.   "
176789|NCT00149032|"     Allogeneic stem cell transplantation is the only effective treatment to patients resistant to     conventional chemotherapy. Donor lymphocytes infusion (DLI) serve as a routine treatment of     choice for patients relapsing following allogeneic stem cell transplantation. The present     proposal is presented for introducing the use of immune rather than naive donor lymphocytes     for patients with resistant relapse and resistant to DLI. DLI primed in-vitro against tumor     cells of host origin or against host alloantigens presented by parental alloantigens in one     way mixed lymphocytes culture can induce much more than potent graft-vs-leukemia and     graft-vs-tumor effects, while down-regulating graft-vs-host disease (GVHD).   "
176790|NCT00149045|"     The study is aimed to test the hypothesis that there is anticipation in CMT   "
176937|NCT00158275|"     This study will determine the effectiveness of an intervention consisting of combined     strategies in reducing the symptoms of both depression and chronic back pain.   "
176791|NCT00149058|"     Erythropoietin (EPO) is a naturally occuring hormone which regulates the body's response to     lack of oxygen and controls the number of red cells in the blood. Recent studies in animals     have shown that EPO has protective effects when organs such as the heart and brain are     injured by lack of oxygen due to reduced blood supply.      We wish to test the idea that giving a patient, who is having a heart attack, an injection of     EPO will reduce the size of the heart attack.   "
176792|NCT00149071|"     A doubleblind randomised trial with active versus sham rTMS in combination with escitalopram     in patients with prior treatment resistant depression in an acute 12 weeks trial with     subsequent 24 weeks study phase with active versus placebo citalopram   "
176793|NCT00149084|"     The eradication rate of the standard H. pylori eradication therapy (such as the triple     therapy with a proton pump inhibitor [PPI], amoxicillin and clarithromycin) depends on     bacterial susceptibility to clarithromycin and genotypes of CYP2C19 in patients. The     investigators intend to investigate whether the tailored therapy based on the two     above-mentioned factors increases the cure rate of the initial eradication therapy.   "
176794|NCT00149097|"     The study aims to characterise the influence of the autonomic nervous system activity on the     development of the lipodystrophy syndrome in HIV-infected patients by measuring heart rate     variability and various metabolic pathways in HIV patients receiving highly active     antiretroviral therapy.   "
176795|NCT00149110|"     The primary objective of the present study is to examine whether the combination of the     antidepressant duloxetine and chronotherapeutic methods (including sleep deprivation, light     therapy, and maintaining a regular sleep-wake rhythm) in patient with major depression, will     induce an immediate improvement from depression and whether this antidepressive effect will     be maintained in the long term (29 weeks). Patient will be randomised to the above mentioned     treatment or to an active group receiving exercise.   "
176796|NCT00149123|"     Major burns trigger the release of circulating mediators, as cytokines and endotoxin that     induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to     those seen in septic shock. After the initial hypovolemic phase, patients with extensive     burns often present a shock with increased cardiac output and reduced systemic vascular     resistances. As described in septic shock, we test the hypothesis that low-dose     hydrocortisone could decrease the duration of the shock period.   "
176797|NCT00149136|"     ALL patients aged 55 years or older were treated with steroids during one week and Ph+ve     cases were then offered a specific therapy including an induction treatment with steroids,     cyclophosphamide, daunorubicin and vincristine, followed, irrespective of response to     induction chemotherapy, by imatinib, 600 mg daily, combined with intermittent steroids during     2 months. Patients in complete response (CR) were then given 10 blocks of alternating     chemotherapy, including 2 additional two-month blocks of imatinib, for a total treatment     duration of 2 years. Therapy of occult central nervous system leukemia included 5 intrathecal     injections of methotrexate and cranial irradiation.      Duration of therapy : 2 years.   "
176798|NCT00149149|"     Zinc carnosine is a food supplement which is available in the health food shops. The     investigators wish to see if it can reduce intestinal swelling in people who take     non-steroidal anti-inflammatory (anti-swelling) drugs (NSAIDs).   "
176799|NCT00149162|"     The purpose of this study is to evaluate the interest of maintenance treatment with     interleukin-2 by randomizing the patients being not allogeneic transplanted in complete     remission after induction and consolidation chemotherapy concerning the event free survival.   "
176800|NCT00149175|"     Patients with different types of dementia will be recruited and evaluated in national     hospital departments for their usual neurological follow-ups. A blood sample will be proposed     in the field of this research project, and the biological material will be stored at the DNA     and Cell Bank of Institut de Fédératif Recherche (IFR) of Neurosciences (Pitié-Salpêtrière     Hospital, Paris). The clinical research network is already set up for Alzheimer's disease and     frontotemporal dementias, which permits an evaluation according to a clinical standardized     protocol.      Among these disorders, a monogenic sub-group has been identified. In Alzheimer's disease, it     is associated with the APP, PSEN1 and PSEN2 genes, which account only for 75% of the familial     forms with early onset. In frontotemporal dementias, the tau gene mutations account only for     10% of the cases with an autosomal dominant inheritance. The identification of familial forms     with a genetic inquiry in the relatives is essential for a greater knowledge of the molecular     bases of forms not caused by the known genes, using linkage approaches and candidate gene     analysis. The familial forms are also useful for identifying the modifier genes.      In the multifactorial forms, the aim is to assemble a wide cohort of patients and controls     matched for localizing and identifying susceptibility genetic factors. The strategies will     use a candidate gene approach, and in the near future, studies of single nucleotide     polymorphisms (SNPs) spread out in the whole genome. Meanwhile, similar approaches,     particularly with candidate genes, could be used for identifying predictive factors of     tolerance and response to the treatment.      Finally, correlations will be performed with seric markers according to each kind of     dementia.      Specialized clinical teams in diagnosis and follow-up in dementias are assembled for this     project, and in the study of neurological disorders of genetic origin.   "
176801|NCT00149188|"     The purpose of this study is to allow patients with acromegaly, or their partners, to learn     how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised     injections whilst maintaining adequate disease control will be assessed.   "
176802|NCT00149201|"     To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis   "
176803|NCT00149214|"     An open-label randomized Phase II study in order to explore two different sequential     anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable     breast cancer (T2-T4/N0-2/M0).   "
176804|NCT00149227|"     The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor     Blocker, on top of the conventional treatment in high risk patients in Japan with     hypertension in terms of the morbidity and mortality.   "
176805|NCT00149240|"     The main purpose of this study is to determine the effectiveness and safety of one dose of     botulinum toxin type A (Dysport) associated with rehabilitation treatment on pain control in     patients with a type of back pain called primary myofascial pain syndrome.   "
176806|NCT00149253|"     Taken together, studies of the value of pre-emptive analgesia are inconclusive. This     randomized, double-blind, dose-ranging, placebo-controlled study was therefore designed to     test that a reduction in post-operative morphine consumption can be achieved by a single-dose     of etoricoxib before induction of anesthesia.   "
176807|NCT00149266|"     To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia     or subcardia cancer   "
176808|NCT00156143|"     To evaluate in boys and girls the improvement in body composition under GH treatment in     adolescents with CO-GHD who remain partially GHD after GH discontinuation.   "
176810|NCT00156169|"     The effect of fibrates on high density lipoprotein (HDL)-cholesterol levels is suggested to     be mediated by its binding to peroxisome proliferator-activated receptor-g (PPARg). Upon     ligand binding, PPARg heterodimerizes with the 9-cis retinoic acid receptor (RXR), and the     heterodimer regulates gene expression. We assessed the hypothesis that a dual treatment with     fibrate plus 9-cis b-carotene-rich powder of the alga Dunaliella bardawil, as a source of     9-cis retinoic acid, would improve the drug's effect on HDL-cholesterol levels.      patients with plasma HDL-cholesterol levels below 40 mg/dl and triglyceride (TG) levels above     200 mg/dl after fibrate treatment (for at least 6 weeks). are given four capsules of     Dunaliella, providing 60 mg b-carotene/day. The all-trans to 9-cis b-carotene ratio in the     capsules is about 1:1.   "
176811|NCT00156182|"     This study was designed to determine the long-term safety of asoprisnil 10 mg in women with     one or more uterine fibroids after an initial 12 weeks in study M99-144.   "
176812|NCT00156195|"     The objective of this study is to determine the long-term safety of asoprisnil in women with     abnormal uterine bleeding associated with uterine fibroids.   "
176813|NCT00156208|"     The objective of this study is to determine the long-term safety of asoprisnil in women with     symptomatic uterine fibroids who completed the 6 month Study C02-037.   "
176814|NCT00156221|"     The specific is to study the MR morphologic and spectroscopic brain correlates and predictors     of development in children with severe developmental disorders (autistic spectrum disorders     and/or mental retardation and/or language disorders). Given the frequently observed     association of autism with known medical conditions, particularly in cases with comorbid     mental retardation and in cases with atypical autism (Rutter et al., 1994; Gillberg, 1995),     children with suspected autism or related developmental disorders will be asked to     participate in an extensive state of the art laboratory work-up which includes T1 and T2     weighted MRI of the brain. MRI data will be analyzed both qualitatively, looking for focal     abnormalities and degree of myelination, and quantitatively, measuring volumes of total     brain, cerebellum, ventricles and grey and white matter. For research purposes, the work-up     will be supplied with proton Magnetic Resonance Spectroscopy (MRS) of the brain. This data     set provides the opportunity to chart brain-behavior relationships in young children with     suspected autism and related PDD cross-sectionally.   "
176815|NCT00156234|"     Patients suffering from congestive heart failure report reduced exercise capacity. This     skeletal muscle dysfunction is also detectable when using small muscle groups which should     not put any demand on the heart.      We hypothesize that congestive heart failure has systemic effects that causes the skeletal     muscle dysfunction.   "
176816|NCT00156247|"     To determine whether acitretin plus etanercept is more effective than etanercept alone in     clearing psoriasis plaques in adults.   "
176817|NCT00156260|"     The primary purpose of this research is to analyze the cells present in the fluid obtained     via ductal lavage from the nipple of a woman with a known diagnosis of breast cancer. A     portion of the lavage fluid may be used in future breast cancer biomarkers. Remaining lavage     fluid will be used to analyze its biochemical composition, for investigational purposes only.   "
176818|NCT00156273|"     We are trying to develop better ways to detect when cancer therapies are working.   "
176819|NCT00156286|"     This study involves being treated initially with a combination of drugs called irinotecan and     cisplatin (induction therapy), followed by treatment with a drug called Gleevec (maintenance     therapy). The main purpose of this study is to determine if this type of treatment will delay     the growth of the tumor and if so, for how long. The investigators also want to find out how     the tumor is affected solely by induction therapy with irinotecan and cisplatin, what     side-effects occur when Gleevec maintenance therapy is used, and if this treatment (induction     followed by maintenance therapy) will improve the duration of survival   "
176820|NCT00156299|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in cancer cells. It may also help doctors     understand how cancer cells respond to treatment with choline magnesium trisalicylate.      PURPOSE: This pilot clinical trial is studying gene expression in cancer cells during     chemotherapy and the safety of choline magnesium trisalicylate in treating patients with     newly diagnosed acute myeloid leukemia.   "
176821|NCT00156312|"     The purpose of this study is to determine whether the combination of the drugs docetaxel and     capecitabine is effective in treating breast cancer patients.   "
176822|NCT00156325|"     This study will investigate the efficacy of Escitalopram, a Selective Serotonin Reuptake     Inhibitor (SSRI) antidepressant, in the treatment of Bipolar II Disorder.      The use of antidepressants for those with bipolar disorder appears common in clinical     practice but is not countenanced - at least as monotherapy - in formal treatment guidelines.     This view reflects concerns about the possibility of antidepressant drugs inducing switching     and rapid cycling in those with Bipolar Disorder. Although the effectiveness of treating     Bipolar II patients with SSRIs has received very little attention in the literature,     observations of Bipolar II patients treated with SSRIs suggest they may have general mood     stabilising properties. Many patients have reported improvements not only in their depressed     mood, but also a reduction in the severity, duration and frequency of hypomanic episodes.      In this proof of concept study we specifically assess whether a standard dose of an SSRI     antidepressant is more effective than placebo in reducing the frequency, severity and     duration of both depressive and hypomanic episodes.   "
176823|NCT00156338|"     The purpose of this study is to determine whether intraoperative fluid and sodium restriction     decreases postoperative morbidity   "
176830|NCT00156429|"     This is a retrospective review of the data available on patients and their family members     with HCM and prospective follow-up of this cohort for clinical outcome and diagnostic     studies. Genetic samples are being examined in this cohort to determine whether certain to     determine whether certain beta-AR polymorphisms as well as other common genetic polymorphisms     are associated with different morphological features, such as LVH in patients with HCM and     whether these polymorphisms influence the clinical course and outcome in patients with HCM.     For that purpose, we will build a database with clinical information including serial     echocardiographic measurements for patients with HCM that have regular follow up and test     them for beta-AR polymorphisms as well as other common genetic polymorphisms and other known     cardiac-related polymorphisms that can potentially contribute to the morphologic differences     seen in patients with HCM.   "
176824|NCT00156351|"     The overall purpose of this project is to conduct an innovative, culturally-tailored     demonstration project designed to facilitate the adoption and maintenance of regular,     moderate physical activity (i.e., brisk walking) in a sample of sedentary African American     women. In addition, we will test the impact of varying types of counseling and social support     on the adoption and maintenance of regular physical activity and help women improve their     weight control. The core behavioral change program will be based on a comprehensive wellness     oriented website offered by the National Black Women's Health Project (NBWHP). Comparisons     will be made between the effects of the web-based program with only minimal face to face     contacts, primarily for enrollment, data collection, and participant retention, the web-based     program with the addition of telephone counseling and support, and the web-based program with     face to face group counseling and support.      Hypotheses. Hypothesis 1. Participation in the intervention will result in increased physical     activity levels, regardless of the level of social support.      Hypothesis 2. The intervention arm involving the lowest level of social support will be     marginally effective for increasing physical activity levels, and additional social support     will result in significantly improved physical activity levels when compared with the lowest     level of social support.      The specific intervention questions are:        1. How well do the interventions address the program objectives ((quality of          implementation), to be determined through protocol review for operationalization of          theoretical constructs)?        2. Was the program implemented as planned ((fidelity to protocol and dose of intervention),          to be determined from implementation process variables, including characteristics of          women recruited, fidelity to protocols for contact with participants, and quality of          counseling given, where applicable)?        3. Did the program (separately for each format tested) have a significant effect on          potential mediators of behavior change (influence on presumed intermediate outcomes)?          For the purpose of this proposal, a mediator is defined as any barrier to or facilitator          of physical activity participation (e.g., time, self efficacy, social support, access,          perceived norms) as implied in the 12 behavioral objectives that have been specified.        4. What is the optimum type of counseling and support to enhance the on-line activities in          order to produce significant behavior change (importance of various program components)?        5. Did the program (separately for each format tested) have a significant effect on the          primary study outcomes (influence on primary behavioral outcome, e.g., physical activity          by self-report of activity levels or pedometer counts)?        6. Do changes in mediators explain changes in the primary outcomes (multivariate models to          understand if presumed process of behavioral change was observed in practice)?        7. Does the internet only program appear to result in increased physical activity          participation when compared to extant data on trends among Black women in the U.S.          population (what is accomplished with very minimal intervention and how does it compare          with a more extensive program)?   "
176825|NCT00156364|"     A. To study the effects of pancreas transplantation (PT) on the structural abnormalities of     diabetic nephropathy (DN) in patients with type 1 (insulin-dependent) diabetes mellitus (type     1 D). These studies will address the influence of long-term normoglycemia on two stages of     diabetic renal disease.      Due to the difficulties encountered for recruitment of patients to agree to undergo a GFR and     a native kidney biopsy in conjunction with their clinical evaluation visit for transplant, we     are now focusing efforts on obtaining skin biopsies previous to transplant, and then at     regular intervals (3, 6, and 9 months, and yearly) following a successful transplantation.        -  Pancreas Transplantation Alone (PTA). To determine, at 5, 10, and 15 years after PTA,          the effects of normoglycemia on the established lesions of DN in the long-term type 1 D          patients' own kidneys.        -  Islet Transplantation Alone (ITA). To determine, at 5 years after ITA, the effects of          normoglycemia on the early lesions of DN in type 1 D patients' own kidneys.        -  Pancreas Transplantation after Kidney Transplantation (PAK). To determine at 5-10 years          the effects of normoglycemia on the early structural lesions of DN in kidneys          transplanted some years earlier into type 1 D recipients.      Hypothesis: The benefits of PT on the early glomerular lesions of DN will be demonstrable     after 5 years in kidneys exposed to diabetes for a short duration, while in patients with     long-standing type 1 D and more advanced glomerular DN lesions, longer exposure to euglycemia     is necessary to demonstrate arrest or regression of the lesions.   "
176826|NCT00156377|"     In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on     subsequent Staphylococcus aureus infection, a prospective randomized trial was performed     particularly including patients with predisposing risk factors for S. aureus infections.   "
176827|NCT00156390|"     Heart Failure (HF) is a disease of epidemic proportion in the U.S. affecting over 5 million     individuals. It is estimated that in the next year nearly 400,000 new cases will be     diagnosed, 1 million individuals will be hospitalized and 300,000 deaths will occur because     of HF. Approximately half of the deaths will be attributed to worsening pump function while     the remainder will be attributable to sudden cardiac death.      Biventricular (BIV) pacing has recently emerged as an exciting new treatment of advanced HF     with dramatic benefits to some patients. Current candidates include those with ventricular     conduction abnormalities and reduced ejection fraction who continue to suffer from severe HF     symptoms despite optimal pharmacological therapy. Recent clinical trials have demonstrated     that BIV pacing improves myocardial function, functional capacity, quality of life, as well     as reduces the incidence of hospitalization and even prolongs life. Despite all this, about     one third of patients with HF do not benefit from BIV pacing, the so-called 'non-responders'.     Our group and others have shown that there are direct genetic effects of BiV pacing in an     animal model, however, there are gaps in existing knowledge about the effects of left     ventricular (LV) pacing site or genetic influences on the degree of response to this novel     therapy.      This proposal aims at identifying predictors of benefit from Biventricular (BIV) pacing with     the goal of optimizing the degree of benefit and increasing the proportion of patients who     respond to this therapy. Patients who fulfill current indications for BIV pacing will undergo     and echocardiography (echo) with regional tissue Doppler analysis and cardiac imaging     consisting of a myocardial perfusion imaging(EGC rest gated Spect scan using Sestamibi) prior     to implantation of a BIV pacing device. They will then be randomly assigned to empiric versus     echo and Spect scan-guided LV lead positioning. In this latter group, optimal LV pacing site     will be defined as the site of latest peak tissue velocity by tissue Doppler echo and Spect     scan testing. In the empiric group, the LV lead position will be chosen by the masked     operator based on the coronary sinus venous anatomy, on electrocardiographic (ECG) criteria,     or other as per standard of care. Blood would be collected from all patients at the time of     the procedure for analysis of genetic polymorphisms.   "
176828|NCT00156403|"     This pilot study is a feasibility, safety, and preliminary benefits study to look at whether     giving the calcium channel blocker amlodipine to people with hereditary pancreatitis as a     prophylactic measure can reduce the inflammatory process in the pancreas.   "
176829|NCT00156416|"     One of the consequences of breast cancer treatment for younger women is the abrupt onset of     menopause and its related symptoms. Menopausal symptoms disrupt usual activities, alter sleep     patterns and decrease quality of life. The purpose of this randomized feasibility pilot study     is to examine mindfulness meditation for menopausal symptom management for women who are     breast cancer survivors and for women with naturally occurring menopause. The study is     designed to: 1. establish the feasibility of a mindfulness meditation program for women who     experience menopausal symptoms (e.g. hot flushes). 2. explore the treatment benefit of a     mindfulness meditation program for menopausal symptom relief using changes in frequency and     severity of hot flushes; frequency of sleep disruption, various aspects of quality of life     and physiologic stress response (cortisol) as outcome measures. 3. evaluate whether the     treatment benefits of mindfulness meditation differ in menopausal women with naturally     occurring menopause versus women with menopause secondary to chemotherapy for breast cancer.     Participants randomized to the attention control group will be offered meditation training     after completion of the intervention and follow up phases. Participants will attend 8     meditation sessions or 8 attention control sessions. Study variables are Menopausal Hot     Flushes (self report & skin conductance monitoring), Sleep Disruption (Pgh Sleep Quality     Index), Physiologic Stress Response (cortisol), Quality of Life (Menopausal Quality of Life);     and Protocol Design (recruitment & retention rates, exit interviews). A convenience sample of     60 women who experience menopausal symptoms will be recruited.   "
176831|NCT00156442|"     The study is to examine the relationship between sleep apnea and neurocognitive behaviors in     children with cleft lip/palate. Describe the incidence and severity of obstructive sleep     apnea in an unselected population of grade school aged children with surgically repaired     cleft palate.      A. Is the incidence of OSA higher in children with cleft palate than age matched historical     control groups? B. Are nighttime symptoms an adequate screening tool to exclude the diagnosis     of OSA in children with surgically repaired cleft palate? Describe the velopharyngeal closure     patterns during speech in an unselected population of grade school aged children with     surgically repaired cleft palate. Describe the neurobehavioral phenotype of an unselected     population of grade school aged children with surgically repaired cleft palate.   "
176832|NCT00156455|"     This is an exploratory study designed to evaluate the incidence of, and to quantify sleep     disordered breathing following stage I Norwood reconstructive surgery. Sleep disordered     breathing will be correlated with:        1. Elevations in pulmonary vasculature resistance at the time of Stage II surgery.        2. Risks of death   "
176833|NCT00156468|"     In prior work, we found that even children who have been seen by their physicians within the     prior six months were frequently misclassified as having mild rather than persistent asthma.     This study evaluations whether systematic office-based screening assists primary care     physicians in identifying children with significant asthma and improves preventive care for     asthma. We hypothesize that standardized screening in the office setting will improve the     physician's ability to (a) identify children with significant asthma and (b) prescribe     appropriate preventive medications.   "
176834|NCT00156793|"     This study was designed to evaluate the ability of AI-700-enhanced rest-stress     echocardiography to detect coronary artery disease (CAD) in patients with suspected ischemic     heart disease who are indicated for single-photon emission computed tomography (SPECT)     imaging.   "
176835|NCT00156806|"     Breast cancer treatment often involved radiation to the breast. A side-effect of this     treatment is skin redness, itching and burning. Some patients have quite severe reactions.     Our current treatment for this is to avoid any soaps or other skin irritants and to use a     moisturizing cream once all radiation is finished. Aloe vera is believed by many people to be     useful for treatment of skin burns but this has never been proven in a randomized study. The     aim of this study is to compare aloe vera gel versus plan gel versus the standard treatment     to determine if there is any benefit. If there was a benefit of gel treatment over standard     it could make radiation treatments more tolerable for cancer patients.   "
176836|NCT00156819|"     This research study will compare the treatment effects of three different asthma medications     in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled     corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a     combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone,     montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are     all approved for the treatment of asthma. We are looking at whether the three treatments are     equally effective for reducing the number and the severity of asthma attacks in subjects with     mild to moderately severe asthma.   "
176837|NCT00156845|"     This study was designed to evaluate the ability of AI-700-enhanced rest-stress     echocardiography to detect coronary artery disease (CAD) in patients with suspected ischemic     heart disease who are indicated for coronary angiography.   "
176838|NCT00156858|"     A study of pharmacokinetics of daily intravenous busulfan   "
176839|NCT00156871|"     The purpose of this study is to investigate the impact of fatigue in severely affected     transplant patients.   "
176840|NCT00156884|"     This study is designed to determine whether the combination of low dose cisplatin and     strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in     hormone refractory prostate cancer.   "
176841|NCT00156897|"     The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic     patients and whether its safety and tolerability profile is superior to that of orlistat in     such patients   "
176842|NCT00156910|"     This is a 60 week study including a double-blind phase followed by an open-label extension     phase.   "
176843|NCT00156923|"     This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to     further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone     (VIVITROL®).   "
176844|NCT00156936|"     This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to     assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All     subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).      Planned treatment duration was up to 3 years. Alkermes terminated the study for business     purposes in December 2006. The median duration of treatment among all subjects in this     extension study was 43 weeks.   "
176845|NCT00156949|"     Subject incidence of adverse events   "
176846|NCT00156962|"     The purpose of this study is to look at subject incidence of adverse events.   "
176847|NCT00156975|"     Primary endpoint of the study is to prove the superiority of an adjuvant therapy with     oxaliplatin/ capecitabine until the first occurrence of appearance of a tumour. Occurrences     in the meaning of this study are the appearance of a relapse of the tumour, of metastases, of     a second tumour or death of any reason.   "
176848|NCT00156988|"     The objective of the proposed study is to assess whether the application of flammacerium for     2 days is as good as, or even better than, the application of flammacerium for 10 days     regarding woundhealing in partial thickness burns.   "
176865|NCT00157209|"     This is a prospective open label, controlled, randomized study to test the safety and     efficacy of active specific immunotherapy with tecemotide (L-BLP25) for the treatment of     subjects with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC). To be eligible,     subjects entering the trial will have to demonstrate either stable disease or a clinical     response after first-line treatment (chemotherapy alone, or chemotherapy and radiotherapy)     and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.     Following a 3 week washout period, subjects will be stratified by disease status (either     Stage IIIB locoregional disease or Stage IIIB with malignant pleural effusion and Stage IV),     and randomized to either best supportive care (BSC) plus tecemotide (L-BLP25) treatment or     BSC alone.   "
176849|NCT00157001|"     The primary objective of the study is to evaluate the difference in 6-month restenosis rates     in coronary artery lesions treated by photopheresis in addition to angioplasty with stent     placement, as opposed to no photopheresis after angioplasty and stent placement. Restenosis     means the closing up again, or narrowing in diameter, of the previously treated artery, which     may cause reduced blood flow and the re-occurrence of symptoms. Photopheresis is a     therapeutic technique in which a portion of your white blood cells is collected by a blood     separation device and exposed to ultraviolet A light, in combination with the drug 8-MOP     (8-methoxypsoralen), then returned to you.      The secondary objectives are:        1. To compare the incidence of major adverse cardiac events (MACE) between the three          treatment groups for 6 months post-angioplasty. MACE events include death (cardiac          related), myocardial infarction, coronary artery bypass graft surgery, repeat          angioplasty to the target vessel, hospitalization and clinical symptoms.        2. To evaluate the safety of the treatment by comparing the incidence of acute and subacute          thrombosis, bleeding and vascular complications and other non-MACE events every 2 weeks          for 6 months post-angioplasty between the three treatment groups.   "
176850|NCT00157014|"     The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart     transplantation.   "
176851|NCT00157027|"     The objectives of this clinical trial are to:        -  Assess the safety of using extracorporeal photoimmune therapy with the photosensitizing          agent Uvadex in the treatment of HIV-1 infection;        -  Evaluate the effects of this therapy on HIV-1 viral load by polymerase chain reaction          (PCR) analysis;        -  Evaluate the effects of this therapy on CD4+, CD8+ cells and CD4/CD8 ratio;        -  Evaluate the effects of this therapy on the patient's immune system, by skin reactivity          to a standard anergy panel.   "
176852|NCT00157040|"     The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the     treatment of children with hemophilia A. The study consists of 2 parts. Part 1 of the study     is a pharmacokinetic evaluation, and Part 2 is an evaluation of efficacy and safety.   "
176853|NCT00157053|"     The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the     treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a     pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The     study is open to patients who completed Baxter Study 069901.   "
176854|NCT00157066|"     The purpose of this study is to determine how vitamin D supplementation (ergocalciferol)     affects the immune response to mycobacterial infection.   "
176855|NCT00157079|"     The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous     (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.   "
176856|NCT00157092|"     The study was a Phase 1B/2A, uncontrolled, open-label, single-center study in individuals     with congenital AAT (alpha 1-antitrypsin) deficiency. A baseline bronchoscopy with     bronchoalveolar lavage (BAL) was performed 3 to a maximum of 4 weeks prior to the first     administration of study drug. Fifteen eligible subjects were randomized to receive 1 of 3     dosing regimens of rAAT (100 mg daily, 100 mg twice daily, or 200 mg daily) administered via     nebulization for 7 consecutive days. A post-treatment nadir BAL was obtained on study Day 8     (12 hours after last dose for subjects who receive drug therapy twice daily and 24 hours     after the last dose for subjects who receive study product daily). BALs were conducted in the     same lung lobe/segment. Follow-up visits took place on Day 15 and Day 36.   "
176857|NCT00157105|"     The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the     treatment of hemophilia A patients undergoing surgery.   "
176858|NCT00157118|"     The purpose of this study is to show that Protein C Concentrate is a safe and effective     treatment for subjects with congenital protein C deficiency. Depending on the type of     treatment required, patients are assigned to one of 3 study parts: Part 1 is for the     treatment of acute episodes, Part 2 is for short-term prophylaxis, and Part 3 is for     long-term prophylaxis in infants aged less than 6 months only.   "
176859|NCT00157131|"     The primary objective of this study is to evaluate skin graft adherence and wound healing in     burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current     standard of care (staples). The primary endpoint is achievement of complete (100%) wound     closure within 28 days.   "
176860|NCT00157144|"     Extracorporeal membrane oxygenation (ECMO) is a means of artificially performing the function     of the human lung and/or heart outside the body. Its use is escalating in a wide range of     clinical settings in the adult population without evidence or guidelines to support this     practice.      This study involves a nationwide questionnaire which has two components. The initial pilot     survey will attempt to identify all institutions currently practicing ECMO or those intending     to do so in the future, and are willing to participate in prospective data collection. The     second phase will involve a monthly survey of these centres regarding the extent of ECMO use,     practice details implemented, and outcome data.      It is hoped that the collection of this information will later assist in the development of     guidelines for this expensive and presently unsubstantiated practice, together with the     construction of appropriate training programs for staff.   "
176861|NCT00157157|"     The purpose of this study is to evaluate whether Antihemophilic factor, recombinant,     manufactured protein-free (rAHF-PFM) is effective and safe in the treatment of hemophilia A     patients who have not been treated with factor VIII (FVIII) before.   "
176862|NCT00157170|"     To evaluate the impact of a supervised exercise program (SEP) on self-efficacy,quality of     life status and cardiovascular fitness among people with HIV in a 24 week randomised     controlled trial.We hypothesised that a combined aerobic and resisted exercise (intervention)     would improve these parameters compared to an individual walking program with monthly group     forum (control).   "
176863|NCT00157183|"     The purpose of this study is to determine whether correction of low nighttime oxygen (O2)     levels and/ or high carbon dioxide levels in patients with cystic fibrosis improves their     quality of life. The treatments being used overnight are (1)O2 (2)pressurised air which     assists breathing (non-invasive positive pressure ventilation, NIPPV)   "
176864|NCT00157196|"     The primary objective is to document the safety of tecemotide (L-BLP25) phase III formulation     in non-small cell lung cancer (NSCLC) subjects with unresectable Stage III disease. This     population includes Stage IIIA NSCLC subjects, a population not studied in former clinical     studies with this vaccine. The secondary objective is to document the survival of subjects     treated.   "
176866|NCT00157222|"     The condition Charcot foot has been known in more than 130 years, and yet there still remains     a large effort to find the cause, diagnostic and medical treatment of the condition.      Charcot neuroarthropathy is a progressive disease of bone and joints characterized by     often-painless bone and joint destruction in limbs that have lost sensory innervation. The     incidence of acute Charcot among diabetic patients is 0,2 % the prevalence is 7,5 %. In the     group of patients with neuropathy the prevalence is even higher –29%.      The diagnosis is often made on a clinical basis, particularly in the early stages of the     condition. The aim of this study is to find a method that makes the diagnosis primarily on     the basis of paraclinical information.      Clinical presentation:      The typical patients have had diabetes in 10 years and have distal symmetrical neuropathy.      The common lesion is unilateral with an acute phase, which may occur either spontaneously or     be triggered by a minor trauma. The foot becomes swollen, warm, red and oedematous. Some     patients have pain, and the condition could be misdiagnosed as cellulites, acute gout, deep     vein thrombosis and osteomyelitis. If the patient has a foot ulcer it is important to rule     out osteomyelitis and cellulites.      In the initial phase it is difficult to make the right diagnose because Charcot is a rare     condition. This leads to a delay in the treatment of the Charcot foot, which, for the moment,     is reduction of weight bearing. The patient is equipped with an air cast, and the non     weight-bearing regime is in some cases maintained in 12 months.      The chronic Charcot is characterized by established deformity. The deformity can be in     different sites in the foot, the most common is in the mid foot. Because of the deformity     there is abnormal weight pressure on the weight bearing sites on the foot. This is associated     with callus formation and there is a higher risk for ulceration.   "
176867|NCT00157235|"     The objective of this trial is to determine whether tiotropium inhalation capsules (Spiriva,     Bromuro de Tiotropio), compared to placebo, enhances the improvement in exercise tolerance     seen in patients with chronic obstructive pulmonary disease (COPD) who participate in     pulmonary rehabilitation.   "
176868|NCT00157248|"     To determine the long term safety and efficacy of BIBR 1048 in patients with chronic atrial     fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (ASA).   "
176869|NCT00157261|"     The general aim of this study is to compare the efficacy and safety of tenecteplase to     standard treatment during cardiopulmonary resuscitation in patients suffering from     out-of-hospital cardiac arrest.   "
176870|NCT00157274|"     The investigators designed a compassionate basis phase II study for refractory/relapsed     mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation     of overall response and time to relapse. Other goals to consider are toxicity and time to new     therapy.   "
176871|NCT00157287|"     Protocol directed weaning has been shown to reduce the duration of mechanical ventilation for     patients admitted to the intensive care unit (ICU) of tertiary centres. However, this benefit     has not previously been studied in a community hospital setting. We therefore sought to     evaluate the impact of an evidence-based weaning guideline on the outcomes for patients     receiving mechanical ventilation in the ICUs of community hospitals in a cluster randomized     controlled trial involving 11 community hospitals.   "
176872|NCT00157300|"     Randomized, double blind, placebo controlled, prospective trial investigating the effect of     erythropoietin in renal transplantation.      The investigators postulate that erythropoietin reduces the risk of delayed graft function.   "
176873|NCT00157313|"     The purpose of the study was to evaluate the effects of integrated treatment for patients     with a first episode of psychotic illness. We conducted a randomised clinical trial in     Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547     patients with first episode of schizophrenia spectrum disorder, who has not received     antipsychotic medication for more than 12 weeks.      Patients were randomised to integrated treatment or standard treatment. The integrated     treatment lasted for two years and consisted of assertive community treatment with programmes     for family involvement and social skills training. Standard treatment offered contact with a     community mental health centre.      We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack     of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one     and two years' follow-up.      We found that integrated treatment improved clinical outcome and adherence to treatment. The     improvement in clinical outcome was consistent at one year and two year follow-ups. We will     study further outcome measures such as social network, quality of life, depression and     suicidal behaviour.   "
176874|NCT00157326|"     Purpose: The primary objective of this study is to evaluate the efficacy and safety of     tadalafil when administered once daily at doses of 5 and 20 mg to adult subjects for 8 weeks     with mild to moderate hypertension.   "
176875|NCT00157339|"     Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the     Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2     diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month     follow up period.   "
176876|NCT00157378|"     The study is a multicenter, double-blind, randomized, parallel-group study with first episode     schizophrenic patients. During a treatment phase of 8 weeks the patients are treated with     Risperidone or Haloperidol. Aim of the project is to compare the effects of the atypical     neuroleptic Risperidone with those of the conventional neuroleptic Haloperidol and to     evaluate whether the assumed advantages of atypical neuroleptics compared to conventional     neuroleptics are also present when both medications are administered in rather low daily     dosages (min. 2 mg/d; max. 8 mg/d).   "
176877|NCT00157482|"     Diabetes mellitus is becoming a global epidemic burden. Its chronic cardiovascular     complications, myocardial infarction and stroke, are the main causes of death in diabetic     patients. It was found that low density lipoprotein (LDL) cholesterol concentration is     related to the increased coronary disease risk that could be successfully reduced by     cholesterol-lowering therapy. Furthermore, preliminary evidence suggests that ameliorating     dyslipidemia may be renoprotective in diabetic patients with proteinuria.      Ezetimibe is the first selective inhibitor of cholesterol absorption and it has demonstrated     a high efficacy in lowering cholesterol concentration and an excellent safety profile.     Preliminary data suggest that ezetimibe, combined with a drug that blocks the cholesterol     synthesis (statins), could be even more effective in decreasing cholesterol concentration.     The aim of this study is to evaluate whether ezetimibe-simvastatin combined therapy is     superior to simvastatin monotherapy in ameliorating the lipid profile and albuminuria in type     2 diabetic patients.   "
176889|NCT00157651|"     This study examines whether low intensity, dose adjusted warfarin prolongs the time to     mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of     bleeding.   "
176890|NCT00157664|"     The primary focus of this study is to collect information through diagnostic testing, blood     sample analysis and patient data collection on patients starting hemodialysis to determine     risk and preventative factors of bleeding and clotting events.   "
176878|NCT00157508|"     Aspirin is commonly used for treatment of painful and inflammatory diseases and in the     prevention of the cardiovascular disease. A major drawback of aspirin treatment is the well     recognized gastrointestinal toxicity. Recent research indicate that coupling a nitric oxide     (NO)derivate to the aspirin moiety retains its therapeutic effects while avoiding its     undesirable gastrointestinal side effects. NO has cytoprotective effects, such as blood flow     modulation, mucus release and repair of mucosal injury. NCX4016, a NO-releasing derivative of     acetylsalicilic acid, has been shown to retain the analgesic, anti-inflammatory and     antithrombotic activity of aspirin, but with less gastrointestinal toxicity. In addition,     preliminary data suggested that NCX4016 may restore insulin sensitivity in eNOS deficient     mice.      This study was aimed to evaluate the activity of NCX4016, compared to aspirin, on     albuminuria, insulin sensitivity and cardiac and renal hemodynamic in patients with type 2     diabetes mellitus. The patients after one month of placebo treatment, entered two 1-month     treatments periods, with equivalent doses (800 mg of NCX4016, 325 mg of aspirin) of NCX4016     or aspirin.   "
176879|NCT00157521|"     Pre-eclampsia is a disorder unique to pregnancy affecting both the mother and the fetus.     Hypertension, proteinuria and edema are the most common and well-known maternal clinical     symptoms. The incidence is approximately 6-8%. Pre-eclampsia is one of the leading causes of     maternal and fetal mortality and morbidity associated with pregnancy throughout the world.     The pathophysiology is unknown. At present, the most effective treatment is immediate     delivery.      The researchers' studies contributed to the demonstration that the vasodilator nitric oxide     (NO) is important for correct placentation and that less nitric oxide (NO)- dependent     vasodilation and an excess formation of reactive oxygen species explain poor placenta     perfusion in pre-eclampsia. This reduced NO activity and increased oxidative stress in     pre-eclamptic placenta is related to low bioavailability of L-arginine, the NO precursor.      In this pilot study the researchers want to evaluate whether the administration of L-arginine     to women with a clinical diagnosis of preeclampsia might restore physiological NO production     in the placenta and ameliorate the pregnancy outcome.   "
176880|NCT00157534|"     The objective of the study is to evaluate the safety and efficacy of celgosivir for 12 weeks     in patients with chronic hepatitis C genotype 1 infection.   "
176881|NCT00157547|"     The purpose of the study is to try to see if antidepressant medications cause changes in QEEG     measurements in the brain. QEEG is a mathematical analysis of electrical currents in the     brain using electrodes placed on the scalp. Previous studies have shown that mood improvement     (clinical response) caused by antidepressant medications was preceded by changes in QEEG     measurements in the brain.   "
176882|NCT00157560|"     Over the last few years several novel agents have been defined which are active in the     treatment of relapsed epithelial ovarian carcinoma. Many of these new agents seemed to have     mechanisms of action that are different from Carboplatin and taxol. This trial looks to     evaluate the effectiveness and toxicity of three sequential chemotherapy doublets in the     treatment of women with newly diagnosed ovarian, primary peritoneal or tubal carcinoma.   "
176883|NCT00157573|"     Granulocyte macrophage colony-stimulating factor (GM-CSF) is an immunostimulant and     preliminary data suggests it may change the natural history of prostate cancer and melanoma.     This study looks at ability of GM-CSF to alter disease progression in women who have     recurrent but asymptomatic recurrence of their ovarian cancer.   "
176884|NCT00157586|"     Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in     many developed and newly industrialized nations. Diabetes mellitus represents the single     largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the     primary cause of early death in diabetic patients are cardiovascular complications.     Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi)     and calcium channel blockers (CCBs) have a specific renoprotective effect and that this     effect can be magnified when the two drugs are used in combination. To formally test this     hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND)     study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years     treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10     mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss     and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric     hypertensive type 2 diabetic patients.   "
176885|NCT00157599|"     To determine whether treatment and further investigation can be safely withheld in patients     who present with suspected recurrent deep vein thrombosis (DVT) and have either a (i)     negative D-Dimer or (ii) a positive D-Dimer with normal serial compression ultrasound.   "
176886|NCT00157612|"     Nursing home residents are frequently transferred to hospital for management of pneumonia.     This often leads to hospital related complications and is a burden on the acute care health     system. The purpose of this study is to assess whether managing residents with pneumonia and     lower respiratory tract infection on site in the nursing home can reduce hospital admissions     and can reduce complications and improve quality of life for residents. We have randomized     residents with nursing home acquired pneumonia to on-site management, using a clinical     pathway, versus usual care.   "
176887|NCT00157625|"     Urinary tract infections are the most common type of hospital-acquired infection. The     majority of these infections result from the use of indwelling urinary catheters. Often     caregivers leave them in unnecessarily. The purpose of this study is to assess the     effectiveness of an automatic stop order (automatic removal or urinary catheters when they no     longer needed) in reducing urinary infections.   "
176888|NCT00157638|"     Recent health policy documents have endorsed an integrated model of collaboration between     pharmacists and physicians in primary care. The integration of pharmacists into primary care     has been identified as a priority for primary health care reform in Canada. However, the best     way to do this has not been demonstrated or evaluated. This demonstration project shows the     various ways in which pharmacists can be trained and integrated into different family     practice settings, the processes and costs associated with doing this, and the outcomes     observed. The main hypothesis is that pharmacist integration into family practice will     optimize medication use, clinical care and clinical outcomes. This information provides     policy makers with necessary information about collaboration between pharmacists and family     physicians for their overall goal of reforming the delivery of primary health care to the     population.   "
176892|NCT00157690|"     The primary objective of this study is to determine efficacy of 70 mg alendronate once weekly     compared to placebo. This will be measured by percent changes in lumbar spine(LS) bone     mineral density(BMD) in adult cystic fibrosis(CF)patients after one year of treatment. The     investigators hypothesize that in adult CF patients with osteopenia or osteoporosis,     alendronate 70 mg once weekly will produce a mean increase from baseline in lumbar spine BMD     that is greater than that observed with placebo at 12 months.   "
176893|NCT00157703|"     This is an open-label, single site study to evaluate the safety and tolerability of     intratumoral administration of G207 followed by treatment with radiation therapy in patients     with recurrent/progressive malignant glioma.      This study is a two stage phase 1 study, in which a de-escalating dosing scheme will be used,     i.e. the first patients will receive the higher dose and if excessive toxicity occurs, the     dose will be reduced for the following patients. The purpose of the dose de-escalation phase     is to find the best safe dose of G207.      In the first stage of the study, treatment with G207 will be followed by focal radiation     therapy on the following day, and in the second stage treatment with G207 will be followed by     gamma knife surgery also on the following day.      All patients will return to the clinic 28 days and 3, 6, 9 and 12 months after G207     administration at which time clinical assessments will be performed, and will be followed for     safety and survival at clinic visits or by telephone every 3 months for up to 2 additional     years and annually thereafter.   "
176894|NCT00157716|"     The purpose of this study is to determine whether MC-1 is effective and safe in reducing     cardiovascular and neurological events in patients undergoing high-risk coronary artery     bypass surgery   "
176895|NCT00157729|"     The purpose of this study is to determine whether MC-1 alone and in combination with an ACE     inhibitor is effective in reducing blood pressure and metabolic dysfunctions associated with     diabetes   "
176896|NCT00157742|"     Randomised trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser     Revascularisation (PMR) in patients with Refractory Angina Pectoris.      Hypothesis: difference in exercise tolerance at 12 months between SCS and PMR   "
176897|NCT00157755|"     This study is to evaluate the safety and effectiveness of gastric stimulation in the     reduction of nausea and vomiting in patients with gastroparesis using an approved     Humanitarian device. There are two cohorts in this study based on etiology, one for diabetic     and one for idiopathic.      A maximum of 150 patients (75 diabetic and 75 idiopathic) from up to 15 centers in the United     States will be followed closely for twelve months and then once a year after that until the     study closes.      If you are someone suffering with symptoms of gastroparesis despite trying oral medications,     you may be eligible to participate in a clinical study using a surgically implanted gastric     stimulator.   "
176898|NCT00157768|"     Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die     of sudden cardiac death in the following 2 years. The prognosis appears not improved by     medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol     CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well     established. On the other hand, an implantable defibrillator (ICD) proved to be superior to     medication when used for secondary prevention in patients after cardiac arrest. The question     arises whether ICD therapy is also effective in primary prevention in high risk patients     after acute myocardial infarction. This study determines if patients, who were defined as     high risk patients in the early post infarction phase by means of noninvasive methods,     benefit from primary prevention by means of an ICD. Special emphasis is put on an individual     optimization of the infarction therapy, including beta-blockers.   "
176899|NCT00157781|"     The purpose of the study is to demonstrate the efficiency on AT / AF prevention and     termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in     patients with conventional pacemaker indications.   "
176900|NCT00157794|"     Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases     where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that     pacing even might have unfavourable effects, especially if patients suffer from additional     cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid     ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental     effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the     amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial     fibrillation and the usage of drugs in patients treated with pacemakers with an activated     Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker     settings to minimize the amount of right ventricular pacing.   "
176901|NCT00157807|"     The clinical effects of intra-operative radiofrequency ablation in patients with persistent     or permanent atrial fibrillation and an indication for an implantation of a heart valve     prosthesis or coronary bypass surgery are the purposes of this study. The study will examine     if and to what extent the quality of life and the use of medical care differs between     patients with and without ablation. Furthermore, there will be thorough echocardiographic     examinations of the heart to detect differences between the different treatment groups. The     patients will be followed for one year after treatment.   "
176902|NCT00157820|"     The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to     analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as     compared to single chamber ICD in a non selected population with conventional indication of     ICD implantation.   "
176903|NCT00157833|"     This open randomized, parallel group, 6 week trial in two rural outpatient clinics will     compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin     regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and     children (>10kg).   "
176904|NCT00157846|"     The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients     who need antibradycardia ventricular stimulation (more than 80%); are eligible for the     exchange of an old pacemaker or implantable cardioverter defibrillator (ICD); and have     ventricular dysfunction (left ventricular ejection fraction [LVEF] < 35%). All patients     eligible for participation in the study will be upgraded with a cardiac resynchronization     therapy (CRT)-device and receive either right ventricular or biventricular stimulation in a     crossover protocol. The endpoint is functional performance measured by spiroergometry.   "
176905|NCT00157859|"     Multidrug resistant strains of P.falciparum and P.vivax are becoming increasingly prevalent     in the Asia Pacific rim. To determine the efficacy of locally recommended antimalarial     protocols in Papua, Indonesia, consecutive patients presenting to a rural clinic were     enrolled into a prospective efficacy study. Patients with uncomplicated falciparum malaria     were treated with chloroquine plus sulfadoxine-pyrimethamine and those with vivax malaria     with chloroquine monotherapy. Patients failing therapy received unsupervised oral quinine +/-     doxycycline for 7 days. Follow-up was continued for 42 days for falciparum malaria and 28     days for vivax malaria.      The study hypothesis was that current recommended antimalarial protocols were no longer     effective.   "
176906|NCT00157872|"     A study to compare rofecoxib versus naproxen in the treatment of Chinese patients with     rheumatoid arthritis.   "
176907|NCT00157885|"     The primary aim of the comparative trial is to assess the relative safety and efficacy of two     artemisinin containing regimens: amodiaquine plus artesunate (AAQ) and artekin both     administered once daily for 3 days.   "
176908|NCT00157898|"     This was a prospective, randomized, controlled, open, and multi-center trial conducted to     compare the clinical efficacy and safety of ertapenem with it's comparator before or     following adequate surgical management of complicated intra-abdominal infection.   "
176909|NCT00157911|"     Patients undergo 4-week placebo lead-in and diet period, and 12-week treatment period.     Clinical efficacy and safety is evaluated at weeks 4, 8 and 12. This study takes     approximately 18 weeks for an individual patient to complete including post-visit at week 14.   "
176910|NCT00157924|"     An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6     in diabetics or metabolic syndrome patients in Korea.   "
176911|NCT00157937|"     Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week     wash-out period and 8-week comparator drug or the drug administration period (with cross-over     design) for assessment of the drug efficacy, safety and tolerability.   "
176912|NCT00157950|"     This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age     in Korea.   "
176913|NCT00157963|"     An efficacy and safety study of hydrochlorothiazide (+) losartan potassium compared to     amlodipine at week 12 in Korean patients with essential hypertension   "
176914|NCT00157976|"     The purpose of this study is to confirm the efficacy and safety of rostaporfin (PHOTREX)     photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal     neovascularization (CNV) associated with age-related macular degeneration (AMD).   "
176915|NCT00157989|"     QUESTION:      Is controlled tidal volume delivery during the resuscitation of preterm infants < 28 weeks’     gestation safe and feasible?      BACKGROUND AND RATIONALE: Current resuscitation of preterm neonates follows the Neonatal     Resuscitation Program (NRP) guidelines. During initial resuscitation, neonates are bagged     with self/flow inflating bags to achieve adequate chest rise, heart rate > 100 per minute and     a pink color. When positive pressure ventilation is delivered with a bag, tidal volume is not     measured. It is likely that high tidal volume is delivered to the neonate in order to achieve     a rapid response. The evidence from human and animal model studies suggests that the     initiation of mechanical ventilation and volutrauma associated with continued ventilation,     are associated with an increase in pro-inflammatory mediators in the lungs of the preterm     infants which induce pulmonary injury. This may interfere with the signaling involved in     alveolarization, leading to a decrease in alveolar formation or maldevelopment of the     alveoli, and subsequent evolution to chronic lung disease (CLD) or bronchopulmonary dysplasia     (BPD).      OBJECTIVE: To evaluate the safety and feasibility of controlling tidal volume delivery (and     limiting manual ventilation), during the resuscitation of preterm infants < 28 weeks’     gestation.      STUDY DESIGN AND SETTING: A randomized controlled pilot study of 40 preterm neonates at the     Mount Sinai Hospital.      RESEARCH PLAN: All eligible parents at risk for preterm delivery at < 28 weeks’ gestation     will be approached. After obtaining written informed consent, infants will be randomized to     standard resuscitation according to NRP guidelines (control group) or resuscitation using     controlled tidal volume ventilation (5 ml/kg) (study group), if they require resuscitation.     Crossover to the control group will be allowed if there is clinical deterioration or no     clinical improvement after 3 minutes of intervention.      OUTCOMES:        1. Primary: Apgar scores at 5,10, 15 and 20 minutes and pH, pO2, and pCO2 levels within 1          hour of resuscitation and at 4 hours of life.        2. Secondary: Durations of mechanical ventilation, continuous positive airway pressure          support, low flow oxygen/air requirement; respiratory status of infant at 28 days          postnatal and 36 weeks’ corrected gestational age. Incidences of air leak,          intraventricular haemorrhage and all causes of mortality before discharge from NICU will          be compared.   "
176916|NCT00158002|"     The objective of this study is to assess the long-term safety and effectiveness of topiramate     in the prevention of basilar and hemiplegic migraine in children and adolescents.   "
176917|NCT00158015|"     The purpose of this study is to assess whether tissue doppler imaging is useful in predicting     which patients will respond most to Cardiac Resynchronization therapy ( a type of pacemaker)   "
176918|NCT00158028|"     The purpose of this study is to determine the efficacy of risperidone compared to placebo in     the treatment of the psychotic-like and deficit symptoms of schizotypal personality disorder     (SPD). Treatment with risperidone, a 5HT2 and dopamine D2 blocking agent, holds particular     promise in the treatment of SPD. Unlike traditional antipsychotics, risperidone targets the     deficit or negative symptoms of schizophrenia. The deficit-like symptoms of SPD are therefore     also likely respond to treatment with risperidone. One common complication in the present     psychopharmacologic treatment of SPD with traditional neuroleptics is the fact that many     patients discontinue treatment due to the medication-induced dysphoria. Given initial reports     and the serotonergic component of the risperidone mechanism, risperidone is anticipated to     produce little or no dysphoria.   "
176919|NCT00158041|"     Amifostine is a radioprotective drug which is approved by the US FDA for administration prior     to each radiation treatment using the intravenous route. The study evaluated the safety of     amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting,     hypotension, generalized skin rash, and injection-site skin reactions.   "
176920|NCT00158054|"     The specific aim of the Coronary Patients Evaluation Study (COPES) Project 2 is, within a     Phase-I RCT, to examine patient satisfaction, treatment safety, and symptom reduction     associated with treatment for symptoms of distress and/or depressed mood among post acute     coronary syndrome (ACS) patients, as compared to usual cardiology care. For the purposes of     this study, symptoms of distress and/or depressed mood is defined by a score on the Beck     Depression Inventory (BDI) >10. The specific treatment approach utilized follows the,     Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) Clinical Trial, and     involves up to 6-months of a patient preference, stepped-care protocol. Within this protocol,     patients choose between brief, problem focused psychotherapy and anti-depressant medication.     Treatment progress is reviewed at 2-month intervals, providing opportunities to 'step-up'     treatment if patients are not demonstrating sufficient symptom reduction.   "
176921|NCT00158067|"     This feasibility clinical investigation is designed to demonstrate that the NeuroPace     external Responsive Neurostimulator (model eRNS-300) can safely deliver responsive electrical     stimulation automatically to affect epileptiform activity. The eRNS-300 is based on an     implantable neurostimulator that has been adapted for acute, external use in a hospital     setting.   "
176922|NCT00158080|"     Contrast-induced acute renal failure can be prevented with hemofiltration which is performed     during cardiac catheterization   "
176923|NCT00158093|"     Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the     treatment of high blood pressure, angina, abnormal heart rhythms and following a heart     attack. The purpose of this study is to explore the potential of nebivolol to cause a certain     type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause     this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved     by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known     to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working     hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals     measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.   "
176924|NCT00158106|"     This study investigates the effectiveness and cost-effectiveness of speech and language     therapy for adults who suffer communication difficulties following a stroke.   "
176925|NCT00158119|"     The purpose of this study is to evaluate two types of exercise therapy designed to improve     muscle power and mobility: weighted vest exercise vs. progressive resistance training.   "
176926|NCT00158132|"     Cocaine addiction is a serious health problem with no available medical treatment for     preventing relapse. Amantadine, a medication that improves muscle control, and propranolol, a     medication that lowers blood pressure, may be useful in treating cocaine addiction in     individuals with severe cocaine withdrawal symptoms. This study will evaluate the     effectiveness of amantadine and propranolol in preventing drug relapse among cocaine addicts.   "
176927|NCT00158145|"     Lung cancer is the leading cause of cancer death in the United States. Currently it remains     impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a     mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and     metabolism are a useful tool and available to use. The purpose of this study is to assess the     variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers.   "
176928|NCT00158158|"     Currently one in five high school students smoke. Smoking can harm adolescents well before     they reach adulthood by causing a number of immediate, sometimes irreversible, health risks     and problems. This study will examine whether reducing smoking will facilitate quitting     smoking in adolescents who have unsuccessfully attempted to quit smoking   "
176929|NCT00158171|"     Currently one in five high school students smokes. Smoking can harm adolescents well before     they reach adulthood by causing a number of immediate, sometimes irreversible, health risks     and problems. This study will compare the effectiveness of treatment with bupropion, a     nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers.   "
176930|NCT00158184|"     The purpose of this study is to examine the abuse liability of oxycodone in individuals with,     and without, a history of prescription opioid abuse.   "
176931|NCT00158197|"     The purpose of this study is to determine if different reinforcement procedures (i.e.,     schedules) produce different patterns of long-term abstinence from methamphetamine. We     anticipate that the three contingency management conditions will promote longer periods of     abstinence in the year following treatment relative to the standard control group.     Furthermore, we predict that the intermittent reinforcement procedures will produce longer     periods of continued abstinence (i.e., long-term behavior change) in the year following     treatment than the continuous reinforcement procedure. Finally, we predict that the     intermittent unpredictable schedule will produce longer lasting behavior change than the     intermittent predictable schedule. Methamphetamine use will be measured using urine     toxicology and self-report of methamphetamine use.   "
176932|NCT00158210|"     Methamphetamine abuse has been steadily increasing over the past decade. Rivastigmine is a     medication that may be helpful in treating methamphetamine dependence. The purpose of this     study is to evaluate the effectiveness of rivastigmine in treating methamphetamine dependent     individuals.   "
176933|NCT00158223|"     This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in     the treatment of schizophrenia.   "
176934|NCT00158236|"     Buprenorphine is a medication used to treat opioid addiction, but individuals who use this     drug are at risk of abusing it. A buprenorphine and naloxone combination may reduce the     likelihood of buprenorphine addiction. This study will evaluate the potential for abuse of     buprenorphine and a buprenorphine and naloxone combination in non-dependent opioid users.   "
176935|NCT00158249|"     The Three Aims of this study are (only studies for Aim 1 were completed)        1. Measure the impact of citicoline on marihuana use patterns in subjects' individualized          natural settings and responses to marihuana challenge using functional brain MRI scans.           Hypothesis - 2 g/day citicoline will produce greater reductions in marihuana use and          craving in heavy marihuana users than placebo citicoline over a 8-week treatment period          as measured in their natural environments. The same participants will experience greater          improved brain activation patterns and an improvement in cognitive functioning compared          to placebo controlled subjects.        2. Measure the effects of citicoline on marihuana absorption and metabolism and determine          if these changes parallel changes in subjective and physiological responses in a          laboratory setting.           Hypothesis - Chronic (8 weeks) treatment with 2 g/day citicoline will produce increases          in subjective and physiological effects of both acute marihuana smoking and placebo          marihuana smoking compared to chronic placebo citicoline. Citicoline will have no effect          on marihuana pharmacokinetics.        3. Measure the effects of citicoline on marijuana-induced cue-induced craving and brain          electrical activity (EEG).      Hypothesis - Chronic (8 weeks) treatment with 2 g/day citicoline will reduce objective     measures of marijuana cue-reactivity, and subjective reports of craving in response to     marihuana cues will also be attenuated compared to chronic placebo citicoline treatment.   "
184307|NCT00254800|"     The purpose of this study is the examine the effect of taking exenatide on the blood levels     (pharmacokinetics) of orally-administered contraceptives.   "
176938|NCT00158288|"     Although LAAM, a derivative of methadone, has been successfully used as an alternative to     methadone maintenance in opioid addicts, its effect on concurrent opioid and cocaine abuse     has not been ascertained. Thus, this study proposes to examine the clinical efficacy of low-     and high-dose LAAM maintenance on opioid and cocaine use in opioid-dependent cocaine abusers.     In addition, since contingency management procedures have demonstrated some success in     decreasing cocaine use in cocaine-abusing individuals, this study also proposes to examine     the clinical efficacy of the presence or absence of contingency management procedures     targeting illicit drug use.   "
176939|NCT00158301|"     This study will determine the effectiveness of cognitive behavioral therapy in preventing a     relapse of depressive symptoms in children.   "
176940|NCT00158314|"     This study will determine the effectiveness and cost-effectiveness of three different     treatment strategies in reducing gambling behaviors.   "
176941|NCT00158327|"     This study will determine the impact of a telephone-based care management program for primary     care patients with panic disorder or generalized anxiety disorder.   "
176942|NCT00158340|"     This study will determine the effectiveness of guided self-help treatment in treating     individuals with binge eating disorder (BED).   "
176943|NCT00158353|"     This study will be used to determine the effectiveness of GirlPOWER!, an innovative mentoring     program for adolescent minority girls living in urban areas.   "
176944|NCT00158366|"     This study will determine the effectiveness of a group-based behavioral program for weight     reduction in overweight and obese schizophrenia patients.   "
176945|NCT00158379|"     Time to progression (physical examination and radiologic imaging   "
176946|NCT00158405|"     Interrupting HAART during limited periods of time (structured treatment interruption : STI)     could entail benefits (better long term tolerance, lower drug-induced viral resistance, lower     cost) but also concomitant risks (lower efficacy, higher drug-induced viral resistance). At     present, the benefit/risk ratio of STI is unclear. Several STI trials are in progress in     industrialised countries. This trial aim at assessing the benefits and risks of two different     STI strategies in West Africa.   "
176947|NCT00158418|"     The purpose of the study is to investigate the fixation of the humeral component in total     shoulder arthroplasty for primary osteoarthritis of the glenohumeral joint.Our hypothesis is     that uncemented fixation of the humerus will result in better disease-specific quality of     life, decreased incidence of radiographic loosening, decrease operative time and no increase     in complications.   "
176948|NCT00158431|"     The purpose of this trial is to evaluate the effectiveness of arthroscopy (lavage and     debridement) in conjunction with the best available non-surgical treatment versus the best     available non-surgical treatment alone (medication, health education and physical therapy) in     patients with osteoarthritis of the knee.   "
176949|NCT00158444|"     Patients with large unstable Grade IV articular surface defects, with significant subchondral     bone exposure and who will likely receive a joint replacement will receive the HemiCAP™     Femoral Resurfacing Prosthesis. The Subject Device intends to offer a surgical alternative to     these patients who might otherwise endure years of pain and loss of function while awaiting a     more appropriate age for joint replacement surgery.   "
176950|NCT00158457|"     In the context of Sub-saharian Africa, this trial evaluate one of the most simple treatment     available for HIV-1 infected patients. The combination proposed is a triple antiretroviral     therapy with only one intake of 3 pills per day. This combination has already been studied in     the North countries.      Here in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48     and 96 weeks of treatment.   "
176951|NCT00158470|"     Access to care and treatment using antiretroviral drugs will be expanded in Vietnam in the     next few years. The ANRS 1210 study is a pilot program to evaluate the feasibility of a     simplified antiretroviral treatment using three antiretroviral drugs once a day. The     objectives will be to assess the efficacy and the tolerance of this treatment and to better     understand the difficulties linked to social and behavioural conditions of patients at     different stages during the treatment.   "
176952|NCT00158483|"     Herpes virus type 2 (HSV-2) infection - as a cofactor of human immunodeficiency virus (HIV)     transmission - can be targeted by anti-herpetic specific drugs, either as a continuous     prophylactic treatment during its asymptomatic shedding phase, or as an episodic treatment     during clinically-apparent genital ulcerations. The main objective of this trial will be to     demonstrate that acyclovir treatment given during clinical episodes (primary infection or     recurrences) can reduce genital shedding of HIV, thereby contributing to a reduction of HIV     infectiousness of dually infected individuals (HIV+/HSV+).   "
176953|NCT00158496|"     Chronic hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type     of HCV present in Egypt (genotype 4), has the reputation to respond poorly to Interferon     treatment at the chronic stage. Pegylated Interferon is a new form of Interferon that stays     in the body for longer time and allows the patient to take less injection per week. It has     proved to be more effective than standard Interferon. The combination of two drugs,     Interferon and Ribavirin, is considered to be the best treatment available for chronic     hepatitis C.   "
176954|NCT00158509|"     Genital herpes is a long-life sexually transmitted diseases which infects a large proportion     of women in Africa. Its clinical symptoms are painful sores on the genitals, which heals     after a few days. HIV infection can worsen genital herpes. In turn, it is possible that     genital herpes increases the quantity of HIV secreted at the genital level in women infected     by the 2 viruses. This study is dedicated to verify this hypothesis.   "
176955|NCT00158522|"     Acute hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type of     Hepatitis C Virus present in Egypt (genotype 4), has the reputation to respond poorly to     treatment at the chronic hepatitis stage. Without treatment, 85% of patients with acute     hepatitis C become chronically HCV infected which means that the virus stays present in the     body. Pegylated Interferon is a new form of Interferon that stays in the body for longer time     and allows the patient to take less injection per week. It has also proved to be more     effective than standard Interferon in treatment of chronic hepatitis C.   "
177027|NCT00146458|"     The objective of this study is to determinate whether the adding of FDG-PET is helpful in the     treatment of advanced cervical cancer with concurrent chemoradiation.   "
176956|NCT00158535|"     To show the feasibility of liver transplantation in HCV-HIV coinfected patients. To study the     two-year survival after transplantation, the interaction between HCV and HIV after     transplantation, the influence of HIV on HCV recurrence after transplantation, the     interaction between immunosuppressive and antiretroviral drugs in particular anti-proteases,     immunological follow-up and quality of life of these patients   "
176957|NCT00158548|"     Chloroquine resistant falciparum malaria in Pakistan is prevalent in every malarious area     examined. Resistance to the favoured second-line treatment, sulphadoxine-pyrimethamine S/P is     rising fast. To avert a repetition of the resistance catastrophe that occurred in SE Asia it     is critical to preserve the effective life of SP by using it in combination with artesunate.     Efficacy of ACT with artesunate in combination with chloroquine, SP or amodiaquine for     treatment of malaria (falciparum or vivax) will be examined in malaria patients in Pakistan.   "
176958|NCT00158561|"     To determine whether two cheap antifolates (chlorproguanil-dapsone and     sulfadoxine-pyrimethamine) which work against falciparum malaria in this region are     sufficiently effective against vivax malaria to be deployed in areas where diagnosis is poor     and the burden of malaria is high, a randomised controlled trial of the three drugs is being     undertaken comparing their efficacy in treating malaria.   "
176959|NCT00158574|"     Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan     Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent     preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence     of malaria and anaemia in infants in an area with low SP resistance, low transmission     pressure and high bednet use. However, it is not clear whether this observation can be     generalised to areas with high transmission and high SP resistance. The mechanism of the     protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial     drugs that could be used for IPTi instead of SP.      This study objectives are:        1. Identification of a drug that could be used safely and effectively for IPTi instead of          SP in areas, such as north eastern Tanzania, where there is a high level of resistance          to SP and amodiaquine.        2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a          long acting drug (mefloquine) when used for IPTi.        3. Investigation of the effect of the intensity of transmission on the requirements for a          long or short acting drug for IPTi.        4. Assessment of the effect of IPTi on the development of clinical immunity in children in          low and high transmission areas.      A randomised trial with four treatment regimes is proposed which will be conducted in two     different transmission settings. The four treatment regimens are as follows: (1) placebo; (2)     mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation     with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a     high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is     the incidence of clinical malaria.   "
176960|NCT00158587|"     Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it     accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A     substantial proportion of clinical cases are not caused by infective bites of Anopheles spp,     but by activation of latent hypnozoites in the liver. These relapses may significantly impede     development since each illness may result in 5-15 days of absence from work or school.      Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is     beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in     the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing,     primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may     be a safe and effective alternative to the traditional 14 day course of the drug. The aim of     the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as     effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis     in G6PD deficient individuals.   "
176961|NCT00158600|"     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the     body's cells to break down glycogen (a stored form of sugar) within specialized structures     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates     and is stored in various tissues, especially heart and skeletal muscle, which prevents their     normal function. The overall objective is to evaluate the safety, efficacy, and     pharmacokinetics (PK) of alglucosidase alfa treatment in patients with late-onset Pompe     disease as compared to placebo.   "
176962|NCT00158613|"     This study is a prospective, longitudinal, multi-center, within patient evaluation of     patients with articular cartilage defects of the knee who have had an inadequate response to     a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled     in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months     up to 48-months.   "
176963|NCT00158626|"     The purpose of this study is to investigate the feasibility of undertaking a multi-centre     randomised controlled trial of the effectiveness of a pelvic floor muscle training (PFMT)     intervention for women with pelvic organ prolapse.   "
176964|NCT00158639|"     The control of blood pressure (BP) for patients with hypertension on medications has been     elusive, despite the availability of evidence-based nationally recognized guidelines for     treatment and 30 years of research addressing this. At present, less than 50% of patients     with known hypertension are adequately controlled. If BP control could be improved,     significant decreases in cardiovascular morbidity and mortality would occur.      The purpose of this study is to conduct a randomized controlled trial of the effectiveness of     the provision of home blood pressure measurement and electronic communications (secure     messaging to health care providers) to improve hypertension control.   "
176965|NCT00158652|"     This is a multicentric randomized phase III trial comparing conventional radiotherapy with     concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus     very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell     carcinoma. The main end point is the event free survival.   "
176966|NCT00158665|"     The purpose of the study was to find out if children 5 through 8 years of age who are getting     influenza vaccine for the first time should get one or two doses.   "
177086|NCT00152620|"     The aim of this therapeutic trial is to compare the response of subjects with active IBD to     daily intravenous dexamethasone versus the response to daily intravenous methylprednisolone.   "
176967|NCT00158678|"     This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy     (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients     with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main     end points are the rate of locoregional control and the rate of xerostomia at 2 years.   "
176968|NCT00158691|"     Prospective randomized study in order to compare intravenous versus subcutaneous     administration of amifostine in patients receiving radiotherapy for head and neck cancer.     Salivary flow will be evaluated during few years after the treatment by a clinical     evaluation, the measure of the weight of saliva and a patient benefit questionnaire cotation.   "
176969|NCT00158704|"     Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B     virus (HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and     require continued access to adefovir dipivoxil.   "
176970|NCT00158717|"     To investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B     virus infection (HBV) who have seroconverted while participating in a previous     Gilead-sponsored study of adefovir dipivoxil.   "
176971|NCT00158730|"     To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive     aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in     immunocompromised patients, as determined by overall response rates at end of course of     treatment.   "
176972|NCT00158743|"     The purpose of this study is to determine whether a commercially available anti-digoxin     antibody, Digibind, can delay delivery in patients with severe pre-eclampsia. If so, this     would allow more time for maternally administered steroids to prevent the development of     respiratory complications in premature infants.   "
176973|NCT00158756|"     To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant     administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody     response to the diphtheria antigen after a three-dose primary vaccination course.   "
176974|NCT00158769|"     This compound, GR270773, is a lipid based compound being developed to treat Sepsis. Lipids     are broken down in the body by the liver. This study is designed to see whether the effect of     the drug in people with poorly functioning livers is any different to the effect on healthy     adults.   "
176975|NCT00158782|"     This Phase I, dose finding study evaluates the safety and tolerability of lapatinib, a dual     tyrosine kinase inhibitor, and GW786034, an anti-angiogenesis agent, when given together. The     study first will find the best doses using safety and blood concentration data of both     agents. This is done enrolling stepwise, cohorts of 3 patients each and the last patient     enrolled must reach at least Day 22 of continuous daily dosing before the next cohort at an     increased dose can begin. If a patient in a cohort has a dose limiting toxicity before Day     22, then 3 more patients are studied at that same dose. If 2 of 6 patients have dose limiting     toxicities within the first 22 days, the next cohort receives the next lowest dose. Otherwise     each cohort has an increasing dose of one of the two agents. The second stage of the study     will administer the best doses of the agents to about 16 patients to further study safety and     collect more blood concentration data (more blood samples in the second phase compared to the     first phase). The second stage has the advantage of using the best dose (decreases chance of     receiving a sub-therapeutic dose) while it collects more blood samples and requires slightly     more long clinic visits.   "
176976|NCT00158795|"     To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine     co-administered with or without Chinese DTPw vaccine administered alone in healthy infants     (3, 4 and 5 months of age)   "
176977|NCT00158808|"     To assess the anti-PRP antibody response one month after vaccination in the groups receiving     a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine   "
176978|NCT00158821|"     To compare tenofovir DF plus lamivudine plus efavirenz vs. stavudine plus lamivudine plus     efavirenz in the treatment of HIV-1-infected patients who have never taken antiretroviral     drugs and have a viral load of less than 400 copies/mL at week 48.   "
176979|NCT00158834|"     This study was designed to evaluate if, in children with asthma, a stepwise treatment (five     levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed     combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores     alone results in a sub-optimal treatment when compared to treatment based on cumulative     symptom scores and bronchial hyperresponsiveness (PD20 methacholine).   "
176980|NCT00158847|"     The hypothesis to be tested of this study is that treatment with fluticasone propionate leads     to an initial improvement in symptoms, quality of life and lungfunction and a reduction in     airways hyperresponsiveness. The continued decline of lungfunction in COPD may not be     influenced by longer lasting treatment. Addition of salmeterol will augment the initial     benefits of fluticasone without changing the longterm decline in lungfunction.   "
176981|NCT00158860|"     Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes     simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can     cause GH, although the latter is much more likely to produce frequent recurrences of GH     lesions. Evidence suggests that there are advantages to using suppressive vs. episodic     treatment, which include increased intervals between the pain and discomfort of genital     herpes recurrences. Therefore, this study will collect safety and efficacy data on     suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.   "
176982|NCT00158873|"     The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based     regimen compared with a conventional sedative based regimen in terms of duration of     mechanical ventilation, length of stay in ICU, difference in extubation time and use of     concomitant sedative agents.   "
176983|NCT00158886|"     Patients with rectal cancer who are candidates for pre-operative radiation therapy may be     enrolled in the Phase I, single center study. Patients will have a full blood count,     biochemistry, urinalysis, and ECG for safety evaluation. Sequential cohorts of three patients     will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (45     Gy) over five weeks. The starting dose of oral topotecan is 0.25 mg/m2 to be concomitantly     administered with radiation (45 Gy) x 5 days every week unless the radiation is interrupted     for Holidays/Weekends or toxicity requiring treatment delays occurs. A total of 25 doses are     planned.   "
176984|NCT00158899|"     The purpose of this clinical research study is to compare up to 3 doses of an investigational     drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe,     well tolerated and effective in improving (raising) low levels of good cholesterol,     high-density lipoprotein cholesterol (HDLc), as compared to placebo.   "
176985|NCT00158912|"     The purpose of VAST is to determine whether the Rate Smoothing feature in Guidant’s     PRIZM/VITALITY-family ICDs has an effect on the incidence of ventricular tachyarrhythmias.   "
176986|NCT00158925|"     The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.   "
176987|NCT00158938|"     The purpose of this clinical investigation was to assess the safety and effectiveness of the     EASYTRAK 3 lead   "
176988|NCT00158951|"     The purpose of this clinical investigation is to demonstrate the safety and effectiveness of     the CONTAK® RENEWAL™ 2/4/4HE cardiac resynchronization therapy defibrillator (CRT-D) family     and EASYTRAK® 2 lead in delivering LV-CRT or BiV-CRT with an LV Offset for patients with     heart failure and an indication for an ICD.   "
176989|NCT00158964|"     The primary objective of this clinical investigation is to evaluate the safety and     effectiveness of the EASYTRAK 4 STEERABLE LV lead.   "
176990|NCT00158977|"     The RENEWAL 3 AVT device is designed to treat patients suffering from HF, with a history of     or at risk of developing atrial and ventricular arrhythmias   "
176991|NCT00158990|"     The purpose of this project is to determine whether concurrent treatment of patients with     major depression (unipolar or bipolar) with triiodothyronine (T3) and sertraline, will lead     to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone.   "
176992|NCT00159003|"     There are naturally occuring variations in the genetic makeup of all of us. Some of these     variations may contribute to a change in susceptibility toward different diseases or change     the prognosis.      We are studying these genetic variations in patients with leukemia. The genes we are studying     are those which influence detoxification of drugs and toxins.   "
176993|NCT00159016|"     This is a phase II, multi-center (Israeli), open label, non-randomized trial for every     patient with the specified tumors expressing c-kit or PDGFR. Expression of these kinases will     be investigated in tumor samples obtained at the time of diagnosis or from the time of     recurrent disease. Every patient with positive expression of either of the kinases will be     evaluated for quantitative and qualitative evidence of disease prior to entry into the study,     and if possible, no other treatment will be given concomitantly, to allow evaluation of the     net effect of Glivec on tumor growth kinetics, searching for measurable evidence of response.      Glivec is supplied to the study investigators by Novartis Pharmaceutical. Patients will     receive Glivec 400mg-800mg p.o./day for an exposure period of up to 12 months provided that     in the opinion of the investigator the patient is benefiting from treatment with Glivec, and     in the absence of any safety concern. For patients with brain tumors who are not receiving     concomitant enzyme inducing anti-convulsant drugs, the recommended dose of Glivec is     800mg/day.   "
176994|NCT00159029|"     Alpha thalassemia causes mild anemia and is found in many ethnic groups. Usually it is found     in regions where malaria is endemic. We have found that alpha thalassemia is common in     Ashkenazim, whose countries of origin are in temperate climates.      We are analyzing the alpha globin genes of individuals of many ethnic groups and will compare     to try to define the origin of thalassemia in these individuals of European extraction.   "
176995|NCT00159042|"     Patients with genetic diseases can have widely differing severities. We are looking for     genetic factors which influence the severity of beta thalassemia.   "
176996|NCT00159055|"     Treatment strategy of patients:      Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative     transplantation tolerance.      Whenever indicated, additional post NST DLI given in graded increment, to optimize control of     GVHD.      Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a     CMV-specific peptide followed by administration of immunized donor lymphocytes, or by     injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient     following DLI.      Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or     CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host     by peptide immunization.      Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo     following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with     relevant peptides.   "
176997|NCT00159068|"     Patients with HIV an have a variable course of their infection. We are trying to identify     factors which worsen or ameliorate the course of the disease. Such factors may be related to     metabolism (breakdown) of drugs or to iron handling by the body.   "
176998|NCT00159081|"     Prospective, randomized, double-blind, multi-center study on 1 year course and treatment     outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in     first-episode schizophrenia.   "
176999|NCT00159094|"     This is a phase II trial of Doxil on day 1 and vinorelbine on days 1 and 2 in women with     metastatic breast cancer. Administered every 28 days. A study to assess the safety and     efficacy of Doxil and vinorelbine in metastatic breast cancer.   "
177000|NCT00159107|"     The main aim of this project consists in the investigation of the interaction of behavior     therapy and Acamprosate in the outpatient treatment of alcoholic patients in a randomized,     prospective and (regarding study medication Acamprosate vs. Placebo) double blind design. A     total of 371 patients has been randomly assigned immediately after detoxification to one of     three different outpatient treat-ment conditions.   "
177001|NCT00159120|"     After one year neuroleptic maintenance treatment in patients with first episode     schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized     design) over a period of 1 year. Under both conditions prodrome based early intervention take     place.   "
177002|NCT00159133|"     Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied     in patients with first episode schizophrenia after one year neuroleptic maintenance     treatment. Two groups of patients were followed over a period of 1 year: one further on under     maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.   "
177003|NCT00159146|"     This study investigates the hypothesis that pindolol can accelerate the response to     antidepressants in patients with major depression treated with venlafaxine.   "
177004|NCT00159159|"     Primary Objective:        -  Evaluation of the benefit on renal function of one year of a low dose of ciclosporine          versus the usual dose      Secondary Objective:        -  To evaluate the immunosuppressive efficacy and tolerance of the treatment      Study Duration:      Twelve months for each patient      Study Treatment: Ciclosporine      Group A: low dose >= 130 µg/l < T0 ciclosporinemia < 200 µg/l; Group B: standard dose >= 200     µg/l < T0 ciclosporinemia < 300 µg/l.      Study Visits:      One visit every 15 days, for the first three months; then 1 visit every month, for 6 months;     and 1 visit at 9 and 12 months.      Associated Treatments:        -  Mycophenolate (Cellcept®), 3g a day        -  Corticoids, as used for transplanted patients      Randomization: Randomization will occur when it is decided that ciclosporine will be     introduced.   "
177005|NCT00159172|"     The purpose of this study is to determine whether motor cortex stimulation, a mildly invasive     surgical procedure, is safe and effective in advanced stage Parkinsonian patients who display     side effects with dopaminergic treatment.   "
177006|NCT00159185|"     The purpose of this study is to:        -  Create a database including a description of the patient population that undergoes total          hip replacement with special emphasis on orthopedic and cardiovascular complications and          the quality of life 1 year postoperatively.        -  Characterise the patient at risk for the above mentioned events        -  Create methods for predicting patients at risk for short-term (90 days) and long term (1          year) complications in relation to hip replacement surgery.   "
177007|NCT00159198|"     Amyotrophic lateral sclerosis (ALS) with frontotemporal dementia (FTD) is a rare clinical     entity, in which both disorders are variably associated in the same patient or within the     family. This adult-onset disorder, which is rapidly fatal, occurs in some families with     autosomal dominant (AD) transmission and age-dependant penetrance. Two studies have provided     evidence for linkage of this condition to chromosomes 15 (in a single family) and 9 (in five     families). However, none of these loci have been yet confirmed. Through a national network of     10 centres with specialists for FTD and/or ALS, we have identified 35 probands with ALS-FTD,     including 13 with a family history consistent with AD inheritance.      Mutations in the SOD1 and tau genes, respectively responsible for autosomal dominant forms of     ALS and FTD, will be excluded by direct sequencing. We will then extend the pedigree of the     13 autosomal dominant families to all consenting first, second and eventually third degree     relatives, using well defined criteria for FTD and ALS. The same strategy will be applied to     newly identified families during the course of the project (at least, seven families with AD     inheritance expected). Linkage studies will be performed in the 20 families using markers     from the two candidate regions on chromosomes 9 and 15. Then, refinement of the candidate     region will be obtained by analyzing the linked families with a high density of     microsatellite markers. This should lead to the refinement of the candidate regions, allowing     to search for mutations in candidate genes. Genes located within the critical regions will be     prioritized for their analysis by sequencing, according to their expression in the nervous     system and to their function.      Once the responsible gene(s) will be identified, it will then possible to define its spectrum     of mutations and to establish genotype/phenotype correlations. Alternatively, if none of the     candidate regions is confirmed, a genome wide search will be performed, allowing to identify     one or more loci for ALS-FTD. The same strategy would then be applied to identify the     corresponding gene(s). This project should contribute for identifying the molecular basis of     this devastating disorder with practical consequences for genetic counselling in ALS-FTD     families, and with the perspective of elucidating the pathophysiology of this disorder.   "
177008|NCT00159211|"     In type 2 diabetic patients with poor glycemic control despite maximum classic oral     treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and     subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a     decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is     correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral     abdominal fat in type 2 diabetic patients is of great importance.      Main objective:      To compare visceral and subcutaneous abdominal fat compartment after a six-month bed time     insulin or pioglitazone treatment in type 2 diabetic patients with poor glycemic control     despite a maximal oral treatment with metformin and sulfonylureas.      The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue     should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or     NPH  bed-time  insulin (0.2u/kg/   "
177009|NCT00159224|"     This study will assess the safety, tolerability and antiviral activity of a simplified     PI-based treatment regimen (Kaletra,ä) compared to conventional HAART regimens in patients     infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen.      The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide     spectrum of patients in a number of different clinical trials.6-9 The durable viral     suppression seen after 4 years of therapy10 proves that it can provide effective, long-term     treatment for people with HIV-1.      Data from one of these trials (M97-720),6 an ongoing Phase II study of lopinavir/ritonavir in     combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the     treatment of HIV-1-infection.   "
177010|NCT00159237|"     T.to investigate a possible mechanism of the glucocorticosteroid receptors (GR) defect in     patients with severe COPD by studying the effect of dexamethasone (Dex) on GR- binding,     interleukin production (IL-6/IL-8) and MKP-1 expression in peripheral blood mononuclear cells     blood (PBMC)   "
177011|NCT00159250|"     Duchenne muscular dystrophy (DMD), a fatal muscle degenerative disorder, arises from     mutations in the dystrophin gene. Antisense therapy with the use of antisense     oligonucleotides (AON) has the potential to restore effectively the production of dystrophin,     the defective protein, in >70% of DMD. This could result in increased life expectancy through     improved muscle survival and function. Recent scientific research has demonstrated the     potential of this technique to skip mutated dystrophin exons, restore the reading frame and     generate functional dystrophin protein. Having demonstrated proof-of-principle in human cell     culture and animal model studies, we now intend to determine efficacy and safety of this     approach to induce dystrophin exon skipping in children with DMD.      The specific aim of this phase I/II study is to assess efficacy (dystrophin production) and     safety of intramuscular administered morpholino oligomer directed against exon 51 (AVI-4658     PMO). We are performing parallel preclinical studies to develop methods of systemic delivery     that will be necessary for future phase II/III clinical studies.   "
177012|NCT00159263|"     To investigate a possible interaction between formoterol and budesonide on GR-translocation     and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 mcg) with the     effect of budesonide (200 mcg and 800 mcg) on GR translocation, and to investigate the effect     of the study drugs on exhaled NO (bronchial and alveolar fraction.   "
177013|NCT00159276|"     To investigate a possible mechanism of the GR defect in patients with severe COPD by studying     the effect of dexamethasone (Dex) on GR-GRE binding, expression of inflammatory and     anti-inflammatory factors such as IL-6, IL-8, MKP-1, GILZ, SLPI production in sputum cells   "
177014|NCT00159289|"     The primary aim of this study is to investigate the effects of inhaled lipopolysaccharide     endotoxin (LPS) on bronchial and alveolar exhaled nitric oxide (NO) and NO metabolites and     other inflammatory markers and mediators in exhaled breath condensate, induced sputum, nasal     lavage and mouthwash fluid in healthy non-smokers and current smokers, including patients     with chronic obstructive pulmonary disease (COPD).   "
177015|NCT00159302|"     This pilot study will measure the baseline levels and the intra- and inter-subject     variability of exhaled (alveolar and bronchial) and nasal NO in smoking subjects with mild     and moderate COPD on or off steroid treatment, smoking healthy volunteers and non-smoking     mild asthmatics off steroids, using multiple exhalation flow rates.      In addition, exploratory markers of iNOS activity (eg. 3-nitrotyrosine, nitrite, nitrate and     3-nitro-4-hydoxyphenylacetic acid) in blood, sputum, urine and exhaled breath condensate will     be evaluated. We will also evaluate exhaled and nasal NO in a population of mild asthmatics     in order to obtain baseline and variability data for future clinical studies involving     asthmatic subjects.   "
177016|NCT00159315|"     In this randomised, cross-over, controlled study, a total of 84 subjects will be included: 12     healthy non-smoking volunteers; 12 current smokers; 30 patients with mild steroid-naïve     asthma; and 30 patients with mild-moderate COPD.      Each subject will have 1 screening visit (if necessary) and 2 study visits. At visits 2 and 3     the effects of adenosine 5`-triphosphate (ATP) or adenosine 5`-monophosphate (AMP) challenge,     given in a random order, will be tested.   "
177017|NCT00159328|"     The purpose of this study is to determine whether ablation of uterine fibroids with MR guided     focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues     will allow the effective use of this therapy in women with larger fibroids.   "
177018|NCT00159341|"     This is a clinical research study to assess whether after exhaling a single cigarette smoke     through the nose there are changes in the inflammatory cells and proteins of nasal     secretions.      A single blood sample from each subject will be stimulated with cigarette smoke in the     laboratory to see the effects on inflammatory blood cells.      Comparison of findings between smokers with COPD and Healthy smokers will be carried out.      We hypothesize that some subjects have amplified inflammatory response to a single cigarette,     and these will be those subjects who develop chronic obstructive pulmonary disease (COPD)     after decades of smoking. We hope to develop an acute challenge model that relates to the     causation of COPD. When studying the effects of new drugs, these may be detected in small     numbers of patients in a challenge situation, when we would need to study many more     unchallenged patients to demonstrate drug effects. In clinical research on asthma and     allergy, the nasal allergen challenge has been a very successful model, and we hope to     validate a comparable model for COPD.   "
177019|NCT00159354|"     Neutrophil involvement in the development of COPD by smokers is well recognised. However not     all smokers develop overt lung disease. We have previously shown that uptake of FDG is     related to neutrophil activity and can be measured by PET and that uptake is greater in COPD     patients than normal subjects. We have also shown that FDG−PET shows inflammatory changes in     asymptomatic smokers after cigarette smoking. We plan to investigate the attenuation of this     inflammation by steroid tablets and whether FDG PET can demonstrate this. We also wish to     establish if similar changes are demonstrated after smoking by COPD patients.   "
177020|NCT00159367|"     We intend to use repetitive magnetic stimulation to the quadriceps muscle to try to improve     strength and improve the metabolic function of the muscle.   "
177021|NCT00159380|"     The primary aim of this study is to investigate the effects of oral and inhaled     administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled     NO and NO metabolites in exhaled breath condensate, saliva and nasal lavage fluid in normal     and asthmatic subjects.   "
177022|NCT00159393|"     Kidney stones vary in size from a tiny grain of sand to as large as filling the inside of the     kidney. Treatment decisions depend on the size, location, and composition of the stone. Some     kidney stones can be treated with lithotripsy (breaking up stones inside the body with shock     waves created outside the body) or ureteroscopy (placing a small telescope up the urine     channel to remove the stone). When stones are large in size or in the lower part of the     kidney, a percutaneous (making a passage from the back into the kidney) procedure has been     found to be the best method to remove the stones safely and efficiently. A passage is made     into the back to allow a small telescope to see the stone and break it into fragments for     removal. A small catheter is placed at the end of the procedure to allow the kidney to drain.      The purpose of this study is to record information about your surgery into a database so we     can look at how patients who have had this procedure have done over time. We hope that     reporting the outcomes of this surgery will be helpful to urologists and patients in the     future. There may be certain factors that can be identified through this study as having     better outcomes that may help make future surgeries safer.   "
177023|NCT00159406|"     STATEMENT OF PURPOSE:      Transurethral resection of the prostate (TURP) is the standard surgical intervention for     obstructive benign prostatic hyperplasia (BPH) in all but the largest of glands, which are     typically treated with open simple prostatectomy. Recently, new generation lasers (holmium     and potassium titanyl phosphate [KTP]) have been utilized for BPH treatment. Long-term     follow-up of laser prostatectomy outcomes must be documented to fully characterize the degree     of voiding improvement achievable by these new techniques, the durability of these outcomes,     and the safety profiles of these procedures.   "
177024|NCT00146419|"     The SUN Study is a Centers for Disease Control and Prevention (CDC)-sponsored multi-site     prospective observational cohort study designed to better understand the incidence and     etiology of metabolic and other complications related to effective HIV treatment and longer     survival. The SUN Study is also providing a platform to evaluate a behavioral intervention     designed to reduce HIV transmission through prevention counseling in routine care.   "
177025|NCT00146432|"     The purpose of this study is to determine whether immunoadsorption of LPS, Il-6 and C5a     reduces systemic hyperinflammation, improves immune function and improves organ function in     patients with severe sepsis and septic shock   "
177026|NCT00146445|"     The purpose of this study is to test whether a ten-session behavioral intervention for     HIV-infected injection drug users is effective in reducing sex and injection risk behaviors     that put others at risk for HIV infection, increasing access to or utilization of HIV primary     health care, and increasing adherence to HIV medications.   "
177028|NCT00146471|"     The purpose of this study is to evaluate the efficacy and safety of levetiracetam for     treating alcohol withdrawal syndrome (AWS) in inpatients (vs. placebo). The primary come-out     parameter is the reduction of the total needed amount of diazepam for add-on treatment of     acute alcohol withdrawal symptoms. The secondary come-out parameter are - safety criteria     (AE) - reduction of alcohol withdrawal score over the days.   "
177029|NCT00146484|"     The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes     remains unknown. The purpose of this study is to determine whether a split evening injection     regimen (insulin injections before breakfast, supper and bedtime) leads to better glucose     control and quality of life than twice daily insulin in children and adolescents with new     onset diabetes.   "
177030|NCT00146497|"     Pulmonary inflammation plays an important role in the development of chronic lung disease     (CLD) in preterm infants. This inflammation occurs very early in postnatal life. Any therapy     that could be beneficial in preventing CLD should be started very early. The investigators'     previous double-blind study has shown that early (< 12 hours) postnatal use of intravenous     dexamethasone for 4 weeks significantly suppressed pulmonary inflammation and significantly     reduced the incidence of CLD. However, the use of dexamethasone was associated with increased     incidence of infection and sepsis. Their follow-up study also suggested an increase in the     incidence of psychomotor anomalies. As compared to intravenous administration, endotracheal     instillation will provide more local anti-inflammatory effects and less systemic side     effects. Infants will be eligible for the study if their birth weight (BW) is < 1500 gm and     if they had severe respiratory distress syndrome (RDS) requiring mechanical ventilation     shortly after birth. After informed consent is obtained, the infant will be randomly assigned     depending on the condition of the infant. The primary outcome is the change in cytokines     (interleukin-6, 8, 10 and TNF-α) levels in BAL fluid. Chronic lung disease (CLD) was judged     at 36 postmenstrual weeks. Infants in the study group (S/B group) received surfactant     (Survanta®, Abbott Laboratories, North Chicago, IL; 100 mg or 4 mL/kg/dose) and Budesonide     (Pulmicort®, AstraZeneca Pty Ltd., Australia; 0.5 mg or 1mL/kg/dose), while those in the     control group (S group) received surfactant (Survanta® Abbott, 100 mg/kg/dose) and saline     (1mL/kg).   "
177031|NCT00146510|"     The purpose of the study is to determine the efficacy of resting metabolic rate (RMR) using     BodyGem and BalanceLog in helping overweight and obese individuals manage their weight.   "
177032|NCT00146523|"     Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called     cortisol. Under normal conditions, cortisol and other hormones are created by the body in     response to physical and emotional stress, triggering a healthy stress response. People who     suffer from psychotic major depression may have unusually high levels of cortisol circulating     within them or abnormal patterns of cortisol levels, overloading the stress response     mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If     Corlux can keep the body's cortisol receptors from being overloaded, the stress response     system may return to normal function, which may result in improvement of symptoms. The     purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients     who have been diagnosed with psychotic major depression (PMD).   "
177033|NCT00146536|"     The goal of this study is to determine how often patients who have atypical lobular     hyperplasia (ALH) or lobular carcinoma in situ (LCIS) on core needle biopsy of an imaging     (found by mammogram or breast ultrasound) abnormality will have associated breast cancer at     surgical removal of the area.   "
177034|NCT00146549|"     The purpose of this study is to compare two different combinations of chemotherapy with     trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the     patients will receive trastuzumab in combination with a taxane form of chemotherapy (either     paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with     vinorelbine.   "
177035|NCT00146562|"     The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in     supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell     growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in     chemotherapy recipients.   "
177036|NCT00146575|"     The purpose of this study is to compare the efficacy of paclitaxel- and sirolimus-eluting     stents to prevent re-blockage of small coronary arteries   "
177037|NCT00146588|"     The purpose of this study is to find out what effects (good and bad) a combination of     cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.   "
177038|NCT00146601|"     The purpose of this study is to test the effectiveness and safety of fulvestrant in     premenopausal women with advanced breast cancer.   "
177039|NCT00146614|"     The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD)     after non-myeloablative transplantation can be reduced by using a combination of three immune     suppressive medication; sirolimus, tacrolimus and methotrexate.   "
177040|NCT00146627|"     The purpose of this study is to compare the therapeutic combination of I.V. eflornithine +     oral nifurtimox to the standard IV eflornithine regimen in terms of therapeutic efficacy and     clinical safety, in patients suffering from Trypanosoma brucei gambiense (Tbg) human African     trypanosomiasis (HAT) in the meningoencephalitic phase.   "
177041|NCT00146640|"     The objective of this study is to investigate if low doses of prednisone TRT, given at night     and, with active drug release at 2 am, are more effective in controlling joint stiffness, and     other disease symptoms of rheumatoid arthritis than standard prednisone given in the morning.     Treatment duration per patient takes 12 months (the double-blind comparative study takes 3     months; 9 months subsequent open treatment on the TRT-medication).   "
177042|NCT00146653|"     We propose a comparison between between our standard ACT based heparin management protocol     for children undergoing CPB and a patient-specific heparin concentration-based heparin     management protocol. We hypothesize that a heparin concentration-based anticoagulation     management protocol during CPB in children will result in more effective attenuation of     hemostatic activation as reflected by decreased levels of thrombin formation and, ultimately,     better preservation of hemostasis postoperatively.      An additional 20 patients will be enrolled to address the validation of heparin     concentrations calculated by the Hepcon machine with laboratory-measured heparin     concentrations. These patients will not be randomized and therefore will not receive an     intervention.   "
177043|NCT00146666|"     The purpose of this study is to determine whether 12 weeks of daily home use of the FM220 in     the most affected leg of patients with PAD and claudication, will improve peak walking time     (PWT) at three months as compared with a non-treated control group.   "
177044|NCT00146679|"     The overall purpose of this study is to test the effects of a nurse managed psychoeducational     intervention, consisting of symptom management training (SMT) and cognitive-behavioral     intervention (CBI), during the first year after ICD implantation using a 3 group randomized     clinical trial.   "
177045|NCT00146692|"     Effective control strategies for malaria depend both on preventing disease and on treating     those who become infected to prevent significant morbidity and mortality. There are many     barriers to preventing access to prompt and effective treatment, some of which are amenable     to intervention, others (such as distance to healthcare) less so. This study will concentrate     on modifiable financial barriers to care.      With the aim of increasing health service utilization and reducing morbidity and mortality     among children under five, some governments are currently implementing policies aimed at     reducing financial barriers to health care. There is at the same time an on-going debate     concerning the relative importance of cost as a barrier to health care. Though theoretically     the aim for reducing these barriers should be achieved, its actual impact has not been     directly assessed or demonstrated by means of an intervention trial.      This study aims to determine by means of a randomized trial the impact of reducing such     barriers on morbidity due to severe malaria among children 6 months to five years and on     outpatient utilization. An existing pre-payment scheme in the study area will be utilized to     improve financial access for half of 2500 households who have not registered for either year     I or II. The impact on severe anaemia, mean haemoglobin and anthropometric measurements will     be assessed. Health service utilisation rates will be measured in both groups by active and     passive surveillance. Patient perceptions and health-seeking behaviour will be compared. The     study will contribute to the current debate on the relative importance of cost of care as a     barrier to health care and the potential for the removal of this barrier as a strategy for     malaria control, and on methods to optimise this.   "
177046|NCT00146705|"     The aim of this study was to investigate the long term outcome of Peginterferon alpha-2b with     or without the addition of lamivudine in patients with chronic hepatitis B   "
177047|NCT00152113|"     Sickle cell disease is a life-long blood condition that can cause damage to the brain and     other organs of the body. Children may develop severe, debilitating clinical states, with     stroke or abnormal blood flow to the brain. Treatment generally includes chronic blood     transfusions which may cause iron overload, potentially leading to severe and sometimes fatal     complications.      Hematopoietic stem cell transplant using cells obtained from a sibling or an unrelated     volunteer donor who is a perfect HLA match (same tissue type) for the recipient has shown     to help, and possibly cure, sickle cell disease. Unfortunately, only about 10-20% of sickle     cell patients have a HLA matched sibling donor, and the likelihood of locating an appropriate     HLA matched unrelated donor through the various donor registries is limited.      Stem cells from partially HLA matched family members (also called haploidentical transplant)     is an option currently being explored for this patient population. This type of transplant     has been used and found to be successful in some patients, mostly those with cancers of the     blood. However, there can be significant complications with haploidentical transplant,     primarily infection, failure of the graft to grow (graft failure), and a disorder called     graft-versus-host disease. In addition, few patients with sickle cell disease have undergone     this procedure. Therefore, the risks and benefits of haploidentical transplants for patients     with sickle cell disorder are not as well established as those using an HLA identical sibling     or unrelated donor.      The primary objective of this study is to assess the safety of haploidentical stem cell     transplantation for children and adolescents with severe sickle cell disease and stroke or     abnormal transcranial Doppler ultrasound requiring chronic transfusion therapy. The treatment     plan will be considered safe if there is not excessive toxicity. Toxicity for this protocol     is defined as graft failure/graft rejection, severe acute GVHD, or regimen related death     within 100 days after the last cellular product administered.      Of note, the protocol was closed to accrual in September 2007 as we had met the stopping     rules related to graft integrity (graft failure and graft rejection). Participants currently     enrolled continue to be followed per protocol.   "
177048|NCT00152126|"     Studies have provided evidence that residual microscopic malignant cells in autologous bone     marrow or blood stem cell grafts can contribute to posttransplant relapse. Researchers are     currently exploring different methods in an attempt to purify or purge the stem cell     product to minimize the risk of tumor contamination.      The CD133+ antigen is a protein contained on or expressed on numerous cells in the human     body including specific hematopoietic progenitor (blood forming) cells. However, this antigen     is not expressed on certain cancer cells including neuroblastoma. A technique using the     investigational CliniMACS cell sorting device has been developed in an effort to filter out     only those stem cells that express this CD133+ antigen in order to infuse a hematopoietic     stem cell product with no tumor contamination potential.      The primary objective of this study is to establish safety of treating patients with a high     dose chemotherapy regimen of Busulfan and Melphalan followed by autologous CD133+     hematopoietic stem cell support. Transplants recipients are expected to achieve engraftment     as defined by an absolute neutrophil count of greater than or equal to 500/mm3 for three     consecutive days by day 42-post infusion. Thus, safety of the treatment plan will be     evaluated in terms of failure to engraft by this specific time period.   "
177049|NCT00152139|"     Childhood leukemias which cannot be cured by chemotherapy alone may be effectively treated by     allogeneic bone marrow transplantation. Moreover, for patients with chronic myelogenous     leukemia (CML), allogeneic hematopoietic stem cell transplantation (HSCT) is the only proven     curative modality of treatment. Patients who have received hematopoietic stem cells from an     HLA matched sibling donor have proven to be less at risk for disease relapse and regimen     related toxicity. However, about 70% of patients in need of HSCT do not have an HLA matched     sibling donor. This necessitates the search for alternative donors, which may increase the     risk of a poor outcome.      The nature of the hematopoietic stem cell graft has been implicated as a primary factor     determining these outcomes. The standard stem cell graft has been unmanipulated bone marrow,     but recently several advantages of T-lymphocyte depleted bone marrow and mobilized peripheral     blood progenitor cells (PBPC) have been demonstrated. However, T-cell depletion may increase     the risk of infectious complications and leukemic recurrence while an unmanipulated stem cell     graft may increase the risk of graft vs. host disease (GVHD). A key element in long range     strategies in improving outcomes for patients undergoing matched unrelated donor (MUD) HSCT     is to provide the optimal graft.      The primary objective of this clinical trial is to estimate the incidence of acute GVHD in     pediatric patients with hematologic malignancies who receive HSCT with an unmanipulated     marrow graft. The results of this study can be used as the foundation for future trials     related to engineering unrelated donor graft.   "
177050|NCT00152152|"     Radiostereometric Analysis (RSA) is a new imaging technique used to measure motions in the     spine. It provides more accurate measurements that could help in diagnosing problems in the     spine earlier than standard xray techniques.   "
177051|NCT00152165|"     Twelve subjects will be sought for this study. Six subjects will receive the DYNESYS system     and six subjects will receive a posterior lumbar interbody fusion (PLIF) with the Silhouette     device. All subjects will already be participating in the DYNESYS multi-center study (under     IRB #4884) and will have been randomized to either group. Five tantalum beads will be     inserted into each vertebra associated with the DYNESYS or fusion surgery. Subjects will be     followed in conjunction with the multi-center follow-up schedule and will have RSA exams at     the following time points after surgery: 3, 6, 12, 18, and 24 months. Standing neutral,     flexion, extension, and lateral bending films will be collected at each time point and the     amount of motion in each direction of the marked vertebrae will be measured. The time     points have been selected based on their clinical relevance for comparison against the     standard of care, which is the fusion procedure. Depending on the initial tension of the     annular fibers, it is possible the DYNESYS will exhibit more motion with time. The time     points are important to track the potential changes.   "
177052|NCT00152178|"     This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared     with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM     within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival     will be collected for 5 years after surgery. To evaluate the safety, data on adverse events     will be collected during treatment. Patients'quality of life will be assessed by means of a     questionnaire.   "
177053|NCT00152191|"     This is a randomized controlled study designed to evaluate the relapse-free survival of the     UFT group compared with the CMF group. Patients will be randomly assigned to receive either     CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on     recurrence, and survival will be collected for up to 10 years after enrollment of the final     patient. To assess safety, data on adverse events will be collected for 2 years after the     start of treatment. Patients'quality of life will be assessed by means of a questionnaire.   "
177054|NCT00152204|"     The safety and efficacy of Intermittent Preventive Treatment for malaria and anaemia control     in Infants (IPTi) have already been documented in Southern Tanzania, affording an opportunity     to gain operational experience in developing a strategy for the longer-term implementation of     IPTi. Working in conjunction with national and district-based health authorities, a strategy     will be developed to make IPTi available through routine health services and an effectiveness     evaluation conducted. This will be based on the comparison of process and outcome indicators     in areas with and without IPTi. Information on safety will be consolidated and the effect of     IPTi on the rate of development of drug resistance explored. The acceptability and costs of     implementing IPTi will be monitored and combined with assessments of effectiveness (in terms     of morbidity and mortality) to assess the cost-effectiveness of IPTi.   "
177055|NCT00152217|"     This controlled study is designed to evaluate the efficacy of TS-1 on survival compared with     surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery     followed by treatment with TS-1 within 45 days after curative resection (curability A or B).     To assess the efficacy, data on recurrence and survival will be collected from the time of     enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be     collected from the time of enrollment until 1 year after surgery.   "
177056|NCT00152230|"     This is a controlled study designed to compare relapse-free survival and overall survival in     patients receiving UFT with those in patients receiving surgery alone. Patients will be     randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative     resection. To assess treatment efficacy, data on recurrence and survival will be collected     for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events     will be collected for 12 months after the start of treatment.Evaluations will be separately     done for colon cancer and rectal cancer.   "
177057|NCT00152243|"     This is a controlled study designed to evaluate the efficacy of UFT on survival compared with     surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery     followed by UFT within 6 weeks after curative resection. To assess treatment response, data     on recurrence and survival will be collected for 5 years after enrollment of the last     patient. To evaluate safety, data on adverse events will be collected for 16 months after the     start of treatment.   "
177058|NCT00152256|"     The objective of this study is to determine the safety and efficacy effects of two doses of     asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to     premenopausal subjects with symptomatic uterine leiomyomata.   "
177059|NCT00152269|"     The objective of this study is to determine the safety and effectiveness of asoprisnil in     symptomatic women with abnormal uterine bleeding associated with uterine fibroids.   "
177060|NCT00152282|"     The objective of this study is to determine the safety and effectiveness of 3 asoprisnil     doses when administered to postmenopausal women with Premarin® 0.625 mg.   "
177061|NCT00152295|"     The objective of this study is to determine the long-term safety of asoprisnil 10 mg when     administered to postmenopausal women with Premarin® 0.625 mg   "
177062|NCT00152308|"     The purpose of the study is to evaluate the effectively of coating of coronary stents with     two different doses of rapamycin for the prevention of coronary vessel re-blockage   "
177063|NCT00152321|"     An evidence-based quality improvement intervention will overcome multiple barriers to best     practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk     patients. The intervention will be directed at patients (education and counseling) and their     primary care physicians (reminders and opinion leader generated and endorsed single page     guidelines)   "
177064|NCT00152334|"     The purpose of this study was to determine the efficacy of adding Botox injection to serial     manipulations and castings in patients with clubfoot. The study hypothesis was that the use     of Botox in the setting of serial manipulations and castings is an effective treatment for     clubfoot.   "
177107|NCT00152893|"     In HIV patients, fasting insulin levels decrease with chromium supplementation. This study is     to determine if chromium nicotinate supplementation at 400ug/day for 16 weeks will improve     insulin resistance in HIV patients with metabolic abnormalities.   "
177065|NCT00152347|"     The purpose of this study is to continue the work from the previous review study and     determine the effectiveness of Botox in treating patients with idiopathic clubfoot by     comparing outcomes of subjects treated with manipulation and casting plus Botox (treatment     group) to those treated with manipulation and casting plus placebo (control group).      The null hypothesis is that manipulation and casting plus Botox is not an effective treatment     for idiopathic clubfoot. The alternate hypothesis is that manipulation and casting plus Botox     is an effective treatment for idiopathic clubfoot.   "
177066|NCT00152360|"     The purpose of this study is to determine the effect of using the weight loss medication     Xenical (generic name - orlistat) on weight loss and change in heart disease risk factors in     patients of the Healthy Heart Program Lipid Clinic at St. Paul's Hospital over a three month     period. Xenical works by blocking the body's absorption of dietary fat in the gut, allowing     it to pass through to be excreted, therefore reducing the intake of fat and calories. This is     a pilot study supported by Hoffmann-La Roche Limited which produces Xenical. The aim is to     investigate whether weight loss will also result in reductions in heart disease risk factors     that may allow for less of a need for medications controlling lipid levels, hypertension and     plasma glucose.   "
177067|NCT00152373|"     clinical efficacy and safety of Levetiracetam as add-on therapy in adult Chinese subjects     with partial seizures.   "
177068|NCT00152386|"     Patients will be assigned to one of three treatment groups. Study medication is administered     over a 52 week study duration.   "
177069|NCT00152399|"     To assess the efficacy and safety of the early administration of somatostatin in infusion     during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with     suspicion of PUB.   "
177070|NCT00152412|"     4 week open study to evaluate the safety of levocetirizine in young children (2 - 6 years)     suffering from allergic rhinitis. As secondary objective, this study will assess the efficacy     of the treatment by means of the T4SS (Total 4 symptoms scores of allergic rhinitis) and each     of the 4 individual rhinitis symptom scores   "
177071|NCT00152425|"     A 26 week maintenance study of CDP870 in Crohn's disease   "
177072|NCT00152438|"     The primary purpose of this study is to determine the effects of a full dose (300 mg at hs)     of oral micronized progesterone (OMP) on vasomotor symptoms [VMS] (hot flushes/night sweats),     on forearm blood flow and on lipid levels and blood pressure in menopausal women without     cardiovascular disease and with moderate to severe VMS.      The hypotheses are that progesterone will improve hot flushes, increase endothelium-dependent     forearm blood flow and will decrease blood pressure without change in lipid levels.   "
177073|NCT00152451|"     This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects     with focal epilepsy.   "
177074|NCT00152464|"     The Early Prevention of Asthma in Atopic Children (EPAAC™) . 24 months study to evaluate the     efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24     months old children.   "
177075|NCT00152477|"     A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour     effects (part 2), of CDP791 combined with carboplatin and paclitaxel.   "
177076|NCT00152490|"     A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's     disease   "
177077|NCT00152503|"     This trial will evaluate the efficacy and safety of ucb 44212 as add-on therapy in subjects     with focal epilepsy.   "
177078|NCT00152516|"     To allow pediatric patients with partial onset seizures an opportunity to receive (as     follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment)     open-label levetiracetam treatment, continue studying cognition and behavior in children, and     continue collection of safety/efficacy data.   "
177079|NCT00152529|"     The purpose of this study is to adapt depression prevention interventions of proven benefit     to the primary care setting in a manner that would be acceptable and potentially available to     young adults in the community.   "
177080|NCT00152542|"     Our previous data demonstrated that premature infants treated with inhaled nitric oxide at     birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to     determine whether this benefit continues through school age.   "
177081|NCT00152555|"     The purpose of this study is to see if there is an improvement in patient's quality of life,     pain, and fatigue after undergoing a supervised exercise program. If improvement is found,     this will help guide standard of care with lupus patients with a focus on exercise for     improvement of endurance, pain and overall health.   "
177082|NCT00152568|"     The purpose of this research is to evaluate the effectiveness of checking car seats during     pediatric well-child visits on the use and properness of use of car seats for children 0-8     years. We are following up with families when they return for the next pediatric check up to     see if they are appropriately using car seats for their children.   "
177083|NCT00152581|"     Open-label, single centre study evaluating efficacy and viral kinetics of combination     PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral     clearance demonstrated between 4 – 12 weeks, then randomised to further continued combination     treatment for one of three defined durations. Followed-up for 24 weeks after treatment     cessation.      Objectives:        1. To determine the necessary duration of combination treatment with Pegylated-Interferon          alfa2a (PEGASYS) & Ribavirin in Patients infected with genotype 1, in order to achieve          viral clearance        2. To identify host factors, which are associated with different patterns of virological          response to combination treatment (fast responder, slow responder, non-responder). On          this basis, to identify possible predictors for the duration of antiviral treatment.   "
177084|NCT00152594|"     The purpose of the study is to determine whether voriconazole is as effective as antifungal     prophylaxis in patients undergoing chemotherapy for acute myelogenous leukemia (AML).      Hypothesis: Voriconazole is superior to placebo in the prophylaxis of lung infiltrates until     day 21 after the start of induction chemotherapy.   "
177085|NCT00152607|"     The purpose of this study is to:      determine the safety of donor right hepatic lobectomy as a procedure to provide a liver graft     for living donor liver transplantation.      study the regeneration of liver tissue by volumetric testing for both donor and recipient.      assess if graft and patient survival with living donor transplantation is comparable to that     of cadaveric donor transplantation.   "
177087|NCT00152633|"     Essential hypertension is commonly associated with impaired endothelial function. The retinal     vasculature is morphologically and functionally related to the cerebral vessels because of     the common origin from the internal carotid artery. A recent study in hypertensive patients     demonstrated that endothelial function of the retinal vasculature is impaired in hypertensive     patients and that it can be restored by treatment with an AT1-receptor antagonist. It is not     clear whether this effect is due to blood pressure lowering or whether this is a blood     pressure independent effect. The present randomized, double blind study with a cross over     design addresses this issue by comparing the effects of losartan and metoprolol on retinal     endothelial function in patients with essential hypertension.   "
177088|NCT00152646|"     The aim of the study is to show the implication of platelets in vasodilation using in vivo     and in vitro analysis and to compare the effects of placebo, aspirin and Clopidogrel in this     interaction platelets/vessels.      The effects of 7 days of each treatment will be compared in healthy subjects and patients     with arteriopathy.   "
177089|NCT00152659|"     The purpose of this study is to study how disease processes like tumors or epilepsy spread in     the brain.   "
177090|NCT00152672|"     This prospective randomized cross over study aims to compare nCPAP with mandibular     advancement device for the treatment of sleep apnea syndrome.The effectiveness of nCPAP and     oral appliance on apnea-hypopnea index, daytime sleepiness and quality of life will be     compared in 60 patients.   "
177091|NCT00152685|"     Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery     after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water     after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic     serum albumin is able to reduce intracranial pressure for several days after severe head     injury and thus reduce mortality and morbidity.   "
177092|NCT00152698|"     The retinal vasculature is morphologically and functionally related to the cerebral vessels     due to its common origin from the internal carotid artery. A recent study demonstrated that     endothelium-dependent vasodilation of the retinal vasculature is impaired in patients with     essential hypertension, which is a strong risk factor for stroke. Furthermore, AT1-receptor     blockade was demonstrated to improve retinal endothelium-dependent vasodilation in these     hypertensive patients. Hypercholesterolemia is also a risk factor for ischemic stroke and     impairment of endothelial function has been observed in various vascular beds in     hypercholesterolemic patients, including the coronary and the forearm vasculature. Whether     endothelial function of the retinal vasculature is impaired in patients with     hypercholesterolemia has not yet been investigated. In patients with stroke, AT1-receptor     blockade and angiotensin-converting enzyme inhibition have beneficial effects on clinical     outcome. Alterations of endothelial function of the cerebral vasculature might be one     pathogenetic factor for the beneficial clinical outcome. To further address this issue, the     present study was designed to test the hypothesis that endothelium-dependent vasodilation of     the retinal vasculature is impaired in hypercholesterolemic patients and that endothelial     function can be improved by AT1-receptor blockade.   "
177093|NCT00152711|"     This study aims to evaluate the impact of nasal continuous positive airway pressure (nCPAP)     treatment on liver enzymes in patients with sleep apnea syndrome and nonalcoholic     steatohepatitis. Using a cross over design, the evolution of liver enzymes will be evaluated     in 40 patients during a consecutive period of 6 weeks, with and without nCPAP treatment.   "
177094|NCT00152724|"     Microvascular dysfunctions are critical events in several diseases including diabetes. This     study will develop a methodology for microvascular investigation in human skin. The purpose     of the study is to investigate the physiological response of the cutaneous microcirculation     to physical, thermal, mechanical or chemical stimulations.   "
177095|NCT00152737|"     The whole study is divided in 4 parallel protocols. The first protocol estimates the     reliability of the technique through test-retest recordings. The second protocol aims to     prove that exercise Tcpo2 is efficient to estimate the benefit of proximal revascularisation     on proximal and distal ischemia in patients suffering stage two lower extremity arterial     disease. The third protocol aims at estimating with exercise tcpo2 the eventual apparison of     proximal ischemia after aorto-bi-femoral bypasses. The last protocol is a transversal study     of patients with aorto-bi-femoral bypasses aiming to analyse the presence of proximal and     distal symptoms and ischemia.      The hypothesis for protocol 2 is that TcpO2 at exercise is significantly improved after     surgery at the aortic and primary iliac artery. The hypothesis for protocols 3 and 4 relates     on the hypothesis that a significant number of patients benefiting aorto-bi-femoral bypass     suffer isolated proximal pain/ischemia after surgery.      Amendement to the project has been recently validated to study the neurologic and bone     complication of chronic vascular ischemia   "
177096|NCT00152750|"     In the present study, we examine the question “Will day-time aggression in children improve     when their night-time sleep is treated with pharmacological intervention (i.e. clonidine)?”     There is considerable anecdotal evidence that clonidine may provide an effective alternative     to neuroleptics for treating aggression in children -- first by improving the overall quality     of their sleep, and second by providing a safer and more readily tolerated medication with     fewer side-effects and a greater probability of long-term compliance. This study uses a     double blind placebo controlled design to gather scientific evidence that will help elucidate     the mechanisms underlying this treatment effect and will help clarify the relationship     between sleep disorders and aggression in children. Our results are expected to help     physicians make informed treatment decisions regarding the use of clonidine to improve the     quality of sleep and possibly treat problems with aggression in their pediatric patients   "
177121|NCT00153075|"     The objective of this trial is to compare the total and regional deposition of aerosol in the     lungs and oropharynx of patients with COPD at 3 different inspiratory flow rates following     inhalation of Berodual delivered via the Respimat inhaler and Berodual? delivered via an     HFA-metered dose inhaler.   "
177122|NCT00153088|"     The aim of this study is to compare the preventive effect of Telmisartan(Micardis) versus     placebo control on the transition to overt nephropathy in patients with diabetic nephropathy     manifesting microalbuminuria associated with type II diabetes, and to evaluate the efficacy     and safety of Telmisart (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan,     Telmisartan) for diabetic nephropathy patients.   "
177097|NCT00152763|"     About 30% of patients survive a cardiac arrest, and the majority of these receive an     implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD).     While ICD therapy offers survival benefit over drug therapy, there remain significant quality     of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD     shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating     ICD therapy. The aims of the current study are:        1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with          receiving an ICD for secondary prevention of SCD,        2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e.,          anti-tachycardia pace terminations and shocks); and        3. to explore if the psychosocial intervention results in less need for appropriate ICD          therapies.   "
177098|NCT00152776|"     The purpose of this study is to determine whether ovaria comp. is effective in relieving     climacteric symptoms.   "
177099|NCT00152789|"     This study is based on previous observation that, in men with localized prostate cancer,     non-cancerous prostate tissue is hypoxic, and on the known contribution of hypoxia to the     progression of cancer. Patients undergoing diagnostic prostate biopsy with serum prostate     specific antigen (PSA) less than 10ng/ml and who have given informed consent will have oxygen     measurements of the prostate and peri-prostatic tissue taken with the Eppendorf electrode at     the time of biopsy. The oxygenation of normal prostate tissue will be compared to that of     cancerous prostate tissue. In men with negative biopsies, the prostate tissue oxygen     measurements will be compared with the peri-prostatic tissue oxygen measurements.   "
177100|NCT00152802|"     The trial will compare a group of patients whose immune system is primed with the     pneumococcal conjugate vaccine and then given a boost with polysaccharide vaccine     (prime-boost strategy) vs. a group vaccinated with the standard 23-valent polysaccharide     vaccine alone. It is hypothesized that the conjugate vaccine priming will provide an enhanced     response in these immunosuppressed individuals who may respond poorly to standard     vaccination.   "
177101|NCT00152815|"     The purpose of this study is to evaluate the effect of a one-year nutritional intervention     with either betaine or vitamin E supplementation, or a weight reducing diet and exercise     program on liver steatosis and steatohepatitis.   "
177102|NCT00152828|"     This is a phase I/II study to evaluate the safety and toxicity of celecoxib in combination     with standard concurrent cisplatin and radiotherapy in women with locally advanced cervix     cancer. In addition, we aim to determine the effect of celecoxib (Celebrex) on tumour     oxygenation, interstitial fluid pressure, COX-2 levels, prostaglandin E2 levels, angiogenesis     and apoptosis.   "
177103|NCT00152841|"     Hypothesis:In patients with ulcerative colitis and Crohn's disease diagnosed with mild or     moderate anaemia:        1. iron supplementation will increase disease activity and oxidative stress        2. the addition of antioxidant vitamin will reduce this detrimental effect   "
177104|NCT00152854|"     Many patients with cancer pain have pain not fully controlled on opioids (eg. morphine). The     addition of acetaminophen (Tylenol) to opioids in a small study in cancer patients     demonstrated better pain control without an increase in side effects. This study will     determine if regular acetaminophen improves pain control when added to strong opioids in     patients with cancer pain.   "
177105|NCT00152867|"     Background: Dexamethasone is a steroid, which is often given into the vein before     chemotherapy to help control acute nausea and vomiting. It can also be given as an oral     tablet for patients to take for the two days following chemotherapy to help minimise delayed     nausea and vomiting. In chemotherapy regimens that cause high rates of nausea and vomiting,     the use of dexamethasone is well proven. However, in chemotherapy regimens that generally     cause only minimal to moderate rates of nausea and vomiting, the value of oral dexamethasone     in the 48-hour period after chemotherapy is not well proven, although it is often prescribed.     While dexamethasone does decrease nausea, it causes additional side-effects such as insomnia,     indigestion, anxiety and mood changes. While patients with less vomiting and nausea are     expected to have better quality of life (QOL), for patients with minimal nausea or vomiting,     their QOL might be more affected by the side effects of the dexamethasone treatment than by     the nausea.      Study Design: The study will be performed in patients who will be receiving first line     chemotherapy treatment with a moderate risk of nausea/vomiting. Anti-nausea therapy for acute     nausea/vomiting will be standardised and all patients will receive non-steroidal medication     for delayed nausea control. Each patient will be randomly allocated to receive either oral     dexamethasone or an identical appearing placebo tablet for two days after chemotherapy for     the first cycle of chemotherapy, and then crossed over to the other treatment for the second     cycle. Patients will complete QOL assessments, dexamethasone symptom and nausea and vomiting     questionnaires, as well as nausea/vomiting diaries. This will enable the researchers to     determine the effect of dexamethasone on nausea and vomiting and the impact of both the side     effects of dexamethasone, and of nausea and vomiting, on QOL.      Objectives: The primary objectives are to determine patient preference for dexamethasone or     placebo, and to compare changes in QOL after chemotherapy in patients who receive     dexamethasone with those who receive placebo. The secondary objectives are: (1) to compare     complete protection from delayed vomiting and severity of nausea; (2) to compare differences     in the impact of nausea and vomiting on QOL, and (3) to compare differences in symptoms that     have been associated with dexamethasone (insomnia, anxiety, agitation, mood, etc.) between     patients receiving dexamethasone and those receiving placebo.      Significance: This study will provide data to evaluate whether the benefits of dexamethasone     for delayed nausea and vomiting outweigh potential side effects in patients receiving     chemotherapy with a moderate risk of causing nausea and vomiting. This addresses a problem     that is important to a majority of patients receiving anticancer chemotherapy. If overall QOL     is improved on dexamethasone, then it should be prescribed more frequently, but if QOL is     reduced on dexamethasone, and patients prefer the placebo, then its use as an anti-nausea     medication for delayed nausea after moderately nauseating chemotherapy should be limited to     patients with poor initial control of nausea/vomiting.   "
177106|NCT00152880|"     A large number hepatitis B surface antigen positive individuals are HBeAg negative with     normal liver tests. Historically, such patients were thought to have suppressed viral     replication and were considered to be at low risk for complications. With the use of more     sensitive technology, physicians are now able to identify a group of patients who are HBeAg     negative, have normal liver enzymes, and detectable HBV DNA. Some of these patients develop     signs of liver inflammation and fibrosis on biopsy. We intend to investigate whether normal,     programmed cell death (apoptosis) plays a role in causing the silent liver injury in this     group of patients. In other words the purpose of this study is to see whether apoptosis may     be responsible for the silent liver death and injury that occurs in these so called inactive     carriers who are HBeAg negative, have normal serum ALT values and HBV DNA > 10,000 copies/mL.     In this study the liver biopsies would be routinely collected in the clinic and investigated     for the evidence of inflammation and fibrosis, and special testing would be performed to     detect for evidence of apoptosis. Around 30 patients from UHN would be participating in this     study. This study will test the hypothesis that subjects who are HBeAg negative, have normal     ALT and have HBV DNA ≥10,000 copies/mL will demonstrate an increased rate of apoptosis in     liver tissue compared to healthy age-matched controls. If this hypothesis is confirmed, it     will imply that the previous assumption that this group of patients has inactive disease is     false and would implicate apoptosis as an important mechanism responsible for causing liver     damage. If apoptotic activity is indeed elevated, further study of these pathways could     potentially yield therapeutic interventions to inhibit apoptosis.   "
177137|NCT00153283|"     The purpose of this study is to determine whether antiepileptic drug gabapentin is effective     in the treatment of chronic asthma.   "
177108|NCT00152906|"     A minority of patients with colorectal liver metastases and hepatobiliary cancer (primary     liver cancer) are candidates for surgery, but there are no curative treatment options for     these patients. Their median survival time is 3 to 12 months. Stereotactic radiation (SRT)     (highly conformal radiotherapy (CRT)) is a treatment option for these patients with     unresectable liver cancer, now possible due to improvements in our ability to localize and     immobilize liver tumors and an improved understanding of the partial liver volume tolerance     to radiation. SRT should permit liver tumors to be treated to tumorcidal doses while sparing     the uninvolved liver, decreasing the risk of treatment related normal tissue toxicity. With     such conformal radiation, it is possible to deliver radiation in fewer fractions than     traditionally required, which should be more convenient for patients. In this study, CRT will     be delivered during shallow breathing or breath hold to minimize organ motion due to     breathing, decreasing the volume of normal liver that must be irradiated.   "
177109|NCT00152919|"     Swelling of the prostate can occur during and after a brachytherapy. This swelling can cause     urinary problems ranging from difficulty voiding to urinary retention. The purpose of this     study is to investigate whether Mobicox started one week before brachytherapy and then     continued afterwards is more effective in reducing the risk of needing a catheter than     Mobicox given only afterwards.   "
177110|NCT00152932|"     Impaired ocular blood flow is an important risk factor in the pathogenesis of primary open     angle glaucoma (POAG). A few studies suggest that topical dorzolamide 2% may increase optic     nerve perfusion. The objectives of this study are to learn the effects of dorzolamide on the     retinal and optic nerve blood flow of glaucoma patients.      The present study is a prospective, randomized, double-masked, crossover design study of     newly diagnosed or already treated patients with early glaucoma.      The investigators will check ocular blood flow parameters using the Canon Laser Blood     Flowmeter (CLBF), used to evaluate retinal arteriole blood flow, and the Heidelberg retinal     flowmeter (HRF), which measures blood flow through capillary beds in the retina and optic     nerve head.      Any demonstrated improvements to retinal and optic nerve blood flow with dorzolamide, will     mean that the drug may protect against ischaemic nerve and retinal damage. Any documented     improvement in flow could lead to a major change in the management of glaucoma patients as     well as other retinal ischemic diseases such as diabetic retinopathy and central retinal vein     occlusion.   "
177111|NCT00152945|"     Lipoproteins are large complexes of molecules that transport lipids (primarily triglycerides     and cholesterol) through the blood. The intestine has traditionally been viewed as a     'passive' organ with respect to lipoprotein production, with intestinal lipoprotein     production rates responding mainly to fat ingestion and absorption. The investigators have     recently demonstrated in animal models that there is an overproduction of intestinal     lipoproteins in both the fasted and the fed state. The investigators have also recently     demonstrated that an elevation of plasma free fatty acids (FFAs) stimulates intestinal     lipoprotein in hamsters. It is not known whether intestinal lipoprotein production can be     acutely stimulated by an elevation of plasma FFAs in humans.      Hypothesis: Intestinal lipoprotein particle production in humans can be stimulated by an     acute elevation of plasma free fatty acids.   "
177112|NCT00152958|"     The primary objective is to assess sustained efficacy in patients who have responded to a 6     month treatment with open-label pramipexole.      Secondary objectives are the measurement of severity of the RLS, assessment of early     withdrawal phenomena after termination of trial medication, augmentation under treatment,     sleepiness, quality of life and subjective wellbeing, the physician's clinical assessment of     symptom severity and improvement. Another secondary objective is safety and tolerability of     treatment.   "
177113|NCT00152971|"     To determine the comparative efficacy and safety of two different doses (75mg day 1 followed     by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of     dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day     subcutaneous, in prevention of venous thromboembolism in patients with primary elective total     knee replacement surgery   "
177114|NCT00152984|"     The primary objective of this study is to demonstrate the superiority of tiotropium compared     to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma   "
177115|NCT00152997|"     The objective of this trial is to investigate the efficacy and safety of pramipexole     (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with     primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese     version of the RLS rating scale by the International Restless Legs Syndrome Study Group     (IRLSSG) as a sub-study.   "
177116|NCT00153010|"     Objectives: The objective of this study will be to determine the safety, tolerability, drug     blood levels, and efficacy of each of three doses of NS 2330 (Tesofensine) given once daily     compared with placebo in patients with mild to moderate Dementia of the Alzheimer's Type.   "
177117|NCT00153023|"     The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in     hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure     beyond the target of 130/80 mmHg after one year of treatment.      The primary objective of this study is to show that telmisartan 80 mg is at least as     effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour     proteinuria after one year of treatment.   "
177118|NCT00153036|"     To collect additional confirmatory data on alteplase(rt-PA) in the European setting and to     demonstrate that the treatment of patients between 3 and 4.30 hours of onset of symptoms of     acute ischemic stroke with rt-PA compared to placebo-treated patients will result in an     improved clinical outcome without increase of fatality rate.   "
177119|NCT00153049|"     1. To investigate the dose response of the combination therapy, Telmisartan and          Hydrochlorothiazide for the Japanese patients with Essential Hypertension.        2. To compare this dose response with that in the US study.   "
177120|NCT00153062|"     The purpose of the trial is to determine if extended-release dipyridamole + aspirin     [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis,     Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to     placebo, in the presence of background antihypertensive therapy, in prevention of a second     stroke in patients who have recently suffered a stroke and therefore are at high risk of     suffering another one.   "
177123|NCT00153101|"     The Ongoing Telmisartan Alone and in combination wiht Ramipril Global Endpoint trial     (ONTARGET): The primary objectives are to determine if (a) telmisartan 80mg daily and     ramipril 10mg daily combination therapy is more effective in reducing the composite endpoint     of Cardiovascular Death (CV) death, Myocardial infarction (MI), stroke or hospitalization for     Congestive Heart Failure (CHF) compared with ramipril 10mg alone; and (b) telmisartan 80mg     daily is at least as effective as (i.e. not less effective than) ramipril 10mg daily, on this     endpoint.      Telmisartan Randomised Assessment Study in Angiotension converting Enzyme inhibitor     intolerant subjects with Cardiovascular Disease. (TRANSCEND): The primary objective of the     study is to determine if treatment with telmisartan 80mg daily is superior to placebo     reducing the composite endpoint of Cardiovascular Death (CV), Myocardial Infarction ( MI)I,     stroke or hospitalization for Congestive Heart Failure (CHF) in patients who are intolerant     to Angiotension Converting Enzyme inhibitors.   "
177124|NCT00153114|"     Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo     therapy in pediatric patients with a history of constipation.   "
177125|NCT00153127|"     The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG     laxative versus placebo.   "
177126|NCT00153140|"     The purpose of this study is to compare the safety and efficacy of extended     polyethyleneglycol3350 use to tegaserod in patients with chronic constipation.   "
177127|NCT00153153|"     To evaluate the safety and efficacy of extended use of polyethyleneglycol3350 laxative as     compared to placebo in constipated patients.   "
177128|NCT00153166|"     This trial will test the hypothesis that inflammation and insulin resistance contribute to     reduced walking distance in subjects with intermittent claudication by impairing vascular     reactivity and skeletal muscle metabolic function.   "
177129|NCT00153179|"     This study will test the hypothesis that reduction in release of free fatty acids from     adipocytes will restore insulin-mediated endothelium-dependent vasodilation and skeletal     muscle glucose metabolism in subject with type 2 diabetes.   "
177130|NCT00153192|"     The purpose of this research study is to determine if Marinol alleviates pain in patients     with chronic pain who are currently taking opioids.      The study begins with a 2-hour initial visit followed by three 8-hour appointments at Brigham     and Women's Hospital. At each 8-hour visit, patients receive a dose of medication and     complete surveys relating to pain.      During the first visit a brief examination and a few surveys about pain, quality of life, and     medical history are given. The study doctor then determines if the participant continues to     qualify for the study.      If qualified for the study, patients receive a daily diary to record pain levels and pain     medications; this will take about 5 minutes each day. After completion of the diary, patients     begin the 8-hour visits.      Patients visit the Pain Trials Center three times to receive study medication. After taking     the study medication, participants remain in the clinic for 8 hours to complete hourly     surveys about pain and pain relief.      Subsequent to these visits, patients may enter a 1-month extension where Marinol is taken at     home, and pain levels are recorded in a diary. Participants can change the dose of study drug     to better control pain and side effects, after speaking with study staff. The study then     concludes with a final 30-minute visit to summarize the participant's experience in the     clinical trial.   "
177131|NCT00153205|"     The purpose of this study is to determine how effective ward-based clinical pharmacists and     computerized physician order entry systems are in reducing serious medication errors in     pediatric inpatients.   "
177132|NCT00153218|"     The purpose of this study is to observe clinical outcomes of metastatic breast cancer     patients whose tumors overexpress the Her2neu protein and are being treated with trastuzumab     (Herceptin)either alone or combination with chemotherapy or hormonal therapy.   "
177133|NCT00153231|"     Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and     functional results of an innovative posterior tape in vaginal prolapse repair by vaginal     route, in comparison to the sacrospinous suspension.      Study design, materials and methods This study involves 5 centres in French Public Hospital.     Patients will be randomly allocated to be operated by a sacrospinous suspension or by an     posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the     POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the     PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated     questionnaire on sexual problems. The difference on early post-operative pain should be 30%     (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated     number of patient is 40 in each arm.   "
177134|NCT00153244|"     The purpose of this study is to determine whether antiepileptic drug lamotrigine is effective     in the treatment of chronic asthma.   "
177135|NCT00153257|"     Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal     approach could be improved when a polypropylene mesh is used as tissue support (1). However,     non protected heavy-weight meshes were associated with a high rate of local complications     such as vaginal erosions and dyspareunia (2). The aim of this multicentre study is to     evaluate anatomical and functional results of an innovative low-weight polypropylene mesh     protected by an absorbable hydrophilic film in the prolapse repair by vaginal route, in     comparison by the standard anterior colporrhaphy.      Study design, materials and methods This study involves 15 centres in French Private or     Public Hospital. Patients will be randomly allocated to be operated by a standard anterior     colporrhaphy or by an anterior repair reinforced by a specially designed mesh: UgytexTM     (Sofradim, France). Ugytex is a low-weight (38g/m²) and highly porous (average porosity: 89%,     pores over 1.5mm) polypropylene monofilament mesh offering tissue ingrowth and connective     differentiation for a stable and long-term support. The mesh is coated with a hydrophilic     film composed of atelocollagen, polyethylene glycol and glycerol. The absorbable coating     protects delicate pelvic viscera from the risk of acute inflammation during the healing’s     inflammatory peak. Prolapse severity will be evaluated using the POP-Q system. In order to     evaluate the patient’s quality of life, the validated PFDI and the PFIQ questionnaires will     be used preoperatively and during follow-up (3), as well as a validated questionnaire on     sexual problems. The difference on one-year cure rate should be 15% (80% for the anterior     colporrhaphy and 95% for the mesh repair). Then the estimated number of patient is 97 in each     arm.        1. Julian TM: The efficacy or Marlex mesh in the repair of severe, recurrent vaginal          prolapse of the anterior mid-vaginal wall. Am J Obstet Gynecol 1996;175:1472-5.        2. Milani R, Salvatore S, Soligo M, Pifarotti P, Meschia M, Cortese M. Functional and          anatomical outcome of anterior and posterior vaginal prolapse repair with prolene mesh.          Br J Obstet Gynaecol 2004;111:1-5.        3. Barber MD et al. Psychometric evaluation of 2 comprehensive condition-specific quality          of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol          2001;185:1388-95.   "
177136|NCT00153270|"     The purpose of this study is to determine whether antiepileptic drug sodium valproate is     effective in the treatment of chronic asthma.   "
177139|NCT00153309|"     The purpose of this study is to evaluate the health and arthritis-specific benefits of     participation in the Arthritis Foundation People with Arthritis Can Exercise program and to     collect information to improve community-based dissemination of this program.   "
177140|NCT00153322|"     Community-based environmental approach to obesity prevention targeting first, second, and     third grade students in Somerville, MA.   "
177141|NCT00153335|"     This is a study to determine whether a computerized risk assessment and focused patient     provider interaction can improve health outcomes in an employee population.   "
177142|NCT00153348|"     To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge,     skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors     to prevent, delay and control cardiovascular and other chronic diseases.   "
177143|NCT00153361|"     The purpose of this project is to test the efficacy of an HIV prevention behavioral     intervention to reduce sexual risk for HIV infection among non-injection, substance-using men     who have sex with men (SUMSM). The primary goal of the intervention is to reduce HIV     transmission by reducing the incidence of unprotected anal sex while under the influence of     alcohol and other drugs (AOD).   "
177144|NCT00153374|"     To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge,     skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors     to prevent, delay and control cardiovascular and other chronic diseases.   "
177145|NCT00153387|"     To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge,     skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors     to prevent, delay and control cardiovascular and other chronic diseases.   "
177146|NCT00153400|"     The purpose of this trial is to provide low-income, under- or un-insured 40- to 64-year-old     women with the knowledge, skills, and opportunities to improve diet, physical activity, and     other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic     diseases.   "
177147|NCT00153413|"     To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge,     skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors     to prevent, delay and control cardiovascular and other chronic diseases.   "
177148|NCT00153426|"     To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge,     skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors     to prevent, delay and control cardiovascular and other chronic diseases.   "
177149|NCT00153439|"     The purpose of this study is to examine the efficacy of techniques to enhance participation     in parenting programs.   "
177150|NCT00153452|"     The goal of this project is to pilot-test an instrument that is designed to assess the     relationship between persons who use controlling behavior with intimate partners, as a risk     factor for perpetrating intimate partner violence, and workplace productivity. The goal is to     validate a survey instrument that can be applied to other workplace settings to measure     productivity losses associated with controlling and aggressive behavior, which will serve to     inform the development of workplace interventions designed to prevent intimate partner     violence (IPV). This pilot-test will include two components of a survey conducted with     employees in a workplace setting: questions to determine one’s controlling behavior or     propensity for violence in an intimate relationship, and questions designed to assess levels     of productivity as measured by days missed from work (absenteeism) and days at work with     diminished functional output (presenteeism). We expect productivity to decrease as one’s     controlling behavior or propensity for perpetrating IPV increases. This study represents one     of the first workplace surveys designed to measure workplace productivity as a function of     controlling or violent behavior. Successful results would argue for a more wide-scale testing     of the instrument, which could ultimately lead to the development of workplace interventions     designed to prevent IPV.   "
177151|NCT00153465|"     The study will examine the extent to which a group motivational intervention (ME) impacts     retention, treatment compliance, and long-term outcomes in families with a history of, or     high risk for, child maltreatment.   "
177152|NCT00153478|"     Project CHOICES Efficacy Study is a randomized controlled trial (RCT) designed to evaluate     the clinical efficacy of a brief motivational intervention aimed at reducing alcohol-exposed     pregnancies(AEP)in high-risk preconceptional women. The study is a multi-site collaborative     study between the CDC and three universities. The hypothesis of the study is that a greater     proportion of women will reduce thier risk of having an alcohol-exposed pregnancy after     participating in the Information Plus Counseling (IPC) intervention than do those in the     Information Only(IO) control group.   "
177153|NCT00153491|"     This is a study of how well caregivers of children with malaria adhere to the recommended     regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group     receiving directly observed treatment in hospital or to a group treated at home by the     routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic,     pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and     are used to evaluate drug adherence.   "
177154|NCT00153504|"     The goal of the project is to examine the impact of providing housing for people living with     HIV who are homeless or at imminent risk of homelessness on their HIV disease progression,     risks of transmitting HIV, and medical care access and utilization.   "
177155|NCT00153517|"     The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment     among women at low risk for preterm delivery. The objectives are:        1. To examine the side effects and patient acceptability of oral versus intravaginal          metronidazole.        2. To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV        3. To study the efficacy of oral and intravaginal metronidazole for the prevention of          hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and          maternal infectious morbidity.   "
177179|NCT00159601|"     The purpose of this study is to investigate different aspects of Quality of Life and mental     health in patients under treatment in a child and adolescent psychiatric outpatient clinic     and in the normal population.   "
177180|NCT00159614|"     The purpose of this study is to characterize the safety and tolerability of KW-3902IV and     measure its effect on renal function.   "
177156|NCT00153530|"     The aim of the study is to deliver primary systemic high-dose methotrexate (MTX) treatment to     PCNSL patients and to define the role of whole brain irradiation (WBI) in primary therapy,     i.e., to analyze whether patients who have undergone primary chemotherapy can postpone     irradiation with its possible late sequelae until recurrence without incurring losses in     progression-free and overall survival. This is studied here for the first time worldwide in a     systematic, controlled and randomized manner. In this study, one arm with six cycles of     high-dose MTX and subsequent irradiation (A1), which comes closest to a standard arm of     primary therapy, at least according to the majority assessment, is compared to irradiation     at recurrence with regard to time to progression and overall survival (A2). In primary     therapy failure, it will also be analyzed to what extent salvage therapy with AraC is     equivalent to irradiation as the standard arm with regard to time to progression and     overall survival (arm B1 and B2).   "
177157|NCT00153543|"     To test the hypothesis that immune responses to 23-valent pneumococcal polysaccharide vaccine     (PPV-23) could be improved in Alaska Native elders by immune priming with 7-valent     pneumococcal conjugate vaccine (PCV-7), we assessed post-vaccination immune responses among     Natives aged 55 years and older who were randomized into three arms: (1) one dose of PPV-23     according to current state and ACIP recommendations; (2) one dose of PCV-7 followed two     months later with a dose of PPV-23; and (3) one dose of PCV-7 followed six months later with     a dose of PPV-23.   "
177158|NCT00153556|"     Hib disease rates in rural Alaska before introduction of HIb conjugate vaccine were among the     highest in the world. Since vaccine introduction, rates have fallen by 90% but the disease     has not been eliminated. This study is designed to test one possible means of eliminating Hib     carriage and thus to eliminate person to person transmission and invasive disease.      The objective of this study is to evaluate the effectiveness of community-wide use of Hib     conjugate vaccine for eliminating oropharyngeal Hib carriage in rural Alaska villages.      Secondary objectives include:        -  Determine risk factors for Hib OP carriage including demographic characteristics, and          immunologic characteristics (antibody level and function). This will be accomplished          through a case-control study described below.        -  Measure antibody response to Hib conjugate vaccine among adults who have not previously          received Hib vaccine. This will be accomplished through a cohort study of participating          adults in the vaccine intervention communities.   "
177159|NCT00153569|"     This trial assesses the clinical efficacy of a multiepitope peptide vaccine with GM-CSF and     KLH as immunological adjuvants in stage IV melanoma patients   "
177160|NCT00153582|"     In this trial, HLA-A2+ patients with active AML are vaccinated with a peptide from the     leukemia-associated antigen WT1 together with immunological adjuvants keyhole limpet     hemocyanin (KLH) as T-helper protein and granulocyte macrophage colony stimulating factor     (GM-CSF) 4 times bi-weekly, then monthly.   "
177161|NCT00153595|"     The aim of this double-blind, randomized, parallel group, placebo-controlled study is to     assess the efficacy and safety of EWO1 in patients with moderate to severe perennial allergic     rhinitis (AR).   "
177162|NCT00153608|"     In this trial HLA-A2+ patients with WT1 expressing carcinomas are vaccinated with a peptide     from the leukemia associated antigen WT1 together with immunological adjuvants KLH as     T-helper protein and GM-CSF   "
177163|NCT00153621|"     Among adults with Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome     (AIDS), Chronic Kidney Disease (CKD) has previously been reported to occur in approximately     10% of children with HIV-infection. The frequency of CKD, its causes, and its natural history     in children and adolescents with HIV-infection have not been systematically studied,     particularly in the era of new anti-retroviral medications. The primary aim of this study is     to determine the how common pediatric HIV-infected individuals have evidence of persistent     proteinuria and CKD.   "
177164|NCT00153634|"     This was a randomized multi-center clinical trial to compare the microbiological efficacy,     clinical efficacy, and safety of using standard versus biofilm susceptibility testing of P.     aeruginosa sputum isolates to guide antibiotic selection for treatment of airway infection in     clinically stable patients with CF.   "
177165|NCT00159419|"     The study is designed to evaluate the efficacy and safety of Bisphosphonate Therapy for     Osteogenesis Imperfecta (OI). We, the researchers at Indiana University School of Medicine,     are characterizing the changes effected by oral bisphosphonate therapy and comparing them to     a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in     children with other disorders that result in low bone mass and fractures.   "
177166|NCT00159432|"     This study is for people with colorectal cancer, who have tumors that cannot be completely     removed by surgery. This study is being done to find out how long it takes tumors to grow     after patients receive the drugs capecitabine, oxaliplatin and bevacizumab. Capecitabine     (also called Xeloda) is a drug that has been approved by the FDA for treatment of advanced     colorectal cancer. Capecitabine prevents some colorectal cancer cancer cells from     reproducing, and causes some of them to die. Oxaliplatin (also called Eloxatin) has also been     approved by the FDA for treatment of advanced colorectal cancer. Oxaliplatin prevents some     colorectal cancer cells from reproducing. Bevacizumab is an investigational drug. Bevacizumab     is an antibody (a protein that acts against a specific substance) directed against vascular     endothelial growth factor (VEGF). VEGF promotes the growth of blood vessels that bring     nutrients to cells. Bevacizumab inhibits the growth of colon cancer cells, by blocking the     effects of VEGF. The combination of the drugs used in this study is experimental. The purpose     of this study is to see how long it takes patients' tumors to grow when they are taking this     combination of drugs.   "
177167|NCT00159445|"     This study is for patients with colorectal cancer that has spread and has increased in size     after standard treatments. This study is being done to find out how long it takes their     tumors to grow after treatment with the chemotherapy drugs capecitabine and gemcitabine.     Capecitabine is a chemotherapy drug that has been approved by the FDA for the treatment of     colorectal cancer. We are adding another drug (called gemcitabine), which is approved by the     FDA for the treatment of cancer of the pancreas to see if the ability of capecitabine to     shrink tumors can be improved by adding gemcitabine. The side effects of the combination will     also be evaluated. Another purpose of this study is to measure the levels of certain     substances that affect how the body reacts to the chemotherapy agents in cancer cells (in the     tumor). In addition, the genes (which are the cell's blueprint for these substances) will     also be evaluated in the blood.   "
177168|NCT00159458|"     The purpose of this study is to find out if the combination of gemcitabine and oxaliplatin     chemotherapy will be effective in reducing or eliminating the tumor(s) in patients with     recurrent or metastatic breast cancer.      Gemcitabine is a chemotherapy drug approved by the U.S. Food and Drug Administration (FDA)     for the treatment of pancreatic and lung cancer; oxaliplatin is a chemotherapy drug that is     approved by the FDA for the treatment of colon cancer. Neither gemcitabine nor oxaliplatin     are approved for the treatment of breast cancer. However, both drugs have been shown to     decrease the size of breast cancer tumors.   "
177169|NCT00159471|"     This is a study for patients with advanced pancreatic cancer, using the drugs gemcitabine,     docetaxel and capecitabine. Gemcitabine is a drug that has been approved by the FDA.     Gemcitabine is been approved for treatment of cancer of the pancreas. It is also approved for     treatment of lung cancer in combination with another drug called cisplatin. Docetaxel is a     drug approved by the FDA. Docetaxel is approved for treatment of breast and lung cancer.     Capecitabine is a drug approved by the FDA for treatment of cancer of the colon and rectum.     This study will measure the levels of certain substances in participant's tumors. These     substances (called genes, which are the cell's blueprint for these substances) affect how     people's bodies react to the cancer drugs. Genes will also be measured in participant's     blood. The purpose of this study is to see if these substances can predict survival and     response in patients receiving the study drugs. In this study we wish to find out how long it     takes for patients' cancers to worsen, and how long they survive after receiving the study     drugs. The side effects of the combination of gemcitabine, docetaxel and capecitabine will     also be evaluated.   "
177170|NCT00159484|"     This study is for people with advanced colorectal cancer. This study uses the drugs Celebrex     and EPO906. EPO906 is an experimental drug that has not been approved by the FDA. EPO906 is a     drug that has been shown in the laboratory to cause cancer cells to die and prevents them     from growing and reproducing. Celebrex is a drug that is approved by the FDA for the     treatment of arthritis and prevention of colon polyps. Colon polyps are small growths in the     colon. If not surgically removed, some colon polyps can become cancerous. Some studies have     shown that Celebrex may reduce the side effects of chemotherapy. Other studies have shown     that it may increase the effectiveness of some chemotherapy. Celebrex is not approved by the     FDA for reducing the side effects of chemotherapy or improving the effectiveness of     chemotherapy. The combination of EPO906 and Celebrex in this study is experimental.      The main goal of this study is to see if adding the drug Celebrex to the drug EPO906 will     decrease the amount of diarrhea seen in patients that receive EPO906.      The goal of the first phase of this study is to find the highest dose of EPO906 that can be     given safely with Celebrex. The dose of Celebrex will remain the same for the whole study.     Higher doses of EPO906 will be given to each group of patients. The increase of EPO906 will     stop once more than one patient has serious side effects. The highest dose of EPO906 that can     be given with Celebrex (without serious side effects) will be called the pilot dose.      The goal of the second phase of this study is to find out how tumors respond to these doses     of the drugs. Another purpose of this study is to see how the body processes the EPO906 and     Celebrex. This study will also look at the side effects of these drugs. In this study, we     will measure how long subjects live, how often tumors shrink after receiving the study drugs,     and how long it takes for tumors to increase in size after receiving the study drugs. This     study will also measure the levels of genes, which are the cell's blueprint, in participant's     tumors. Several genes can affect how people's bodies react to the cancer drugs. Genes will     also be measured in participant's blood. We want to see if these predict response to the     study drugs.   "
177171|NCT00159497|"     This study was designed to investigate the influence of HA-coating on bone remodeling around     the cup in cementless THA.      100 patients gave informed consent to participate in a controlled randomized study between     porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation.     The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a     modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral     Density (BMD) determined by DEXA scanning.      Measurements revealed no difference between the two groups after 3 years, neither in clinical     outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above     normal regained more bone mineral than patients with normal weight. This finding supports the     assumption that load is beneficial to bone remodeling. Advantages of better sealing of the     bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be     anticipated for the 7 or 12 year follow-up examinations   "
177172|NCT00159510|"     Nitric oxide (NO) plays a pivotal role in maintenance of normal vascular tone. However, in     sepsis the excessive production of NO results in myocardial depression, vasoplegia, and     cytotoxic effects, thus promoting shock and multiple organ dysfunction. A recently completed     study from our group showed advantageous cardiovascular effects of continuously infused     methylene blue (MB), an inhibitor of NO pathway, in human septic shock. In another     investigation, we have found that the combination of inhaled NO and continuously infused MB     attenuates endotoxin-induced acute lung injury (ALI) in sheep. Our intention is, in a new     study, to test the hypothesis that the combination of MB and NO (MB+NO) improves both     cardiovascular and pulmonary functions as well as clinical outcome in patients with septic     shock and ALI. Forty mechanically ventilated patients diagnosed with hyperdynamic septic     shock and ALI, will be randomized to groups receiving        1. Conventional treatment (control group)(n =10);        2. MB infusion in addition to conventional treatment (n=10);        3. Inhaled NO in addition to conventional treatment (n=10);        4. MB infusion combined with inhaled NO (MB+NO) in addition to conventional treatment          (n=10).   "
177173|NCT00159523|"     A probiotic (Lactobacillus rhamnosus GG) supplement to pregnant women the last four weeks of     pregnancy and three months after birth is expected to give a 40% reduction in risk of atopic     sensitisation and allergic disease at two years of age, compared to placebo.   "
177174|NCT00159536|"     To investigate the effect of metformin on pregnancy complications and pregnancy outcome in     the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.   "
177175|NCT00159549|"     A parallell group study comparing the effect of an education program with an education and     training program for patients with COPD. 30 participants in each group. Participants     self-select which group they wanted to be in. Main outcome is SGRQ (a HQoL for patients with     COPD).   "
177176|NCT00159562|"     The purpose for this study is to determine whether psycho-education in groups is more     effective than individual psycho-education for patients with bipolar disorder.   "
177177|NCT00159575|"     Aim of study: To investigate whether four months of metformin treatment before IVF     (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical     pregnancy rate in normal-weight (body mass index [BMI] below 28 kg/m3) in PCOS (polycystic     ovarian syndrome) women.   "
177178|NCT00159588|"     It is a common belief that patients with MOH rarely respond of preventative medications     whilst overusing acute medications. However, no randomized trial has been done previously to     prove such statement. Based on some clinical experiences, our hypothesis are patients with     probably MOH may benefit from use of preventive medications better than treatment with abrupt     withdrawal or no specific treatment.   "
177181|NCT00159627|"     The purpose of this study is to evaluate the safety of KW-3902IV compared to placebo and to     determine the diuretic effect of KW-3902IV compared to placebo in patients hospitalized with     volume overload due to CHF who are refractory to high dose diuretic therapy.   "
177182|NCT00159640|"     The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of     chronic pain following a shingles infection.   "
177183|NCT00159653|"     To demonstrate statistical superiority of the combination of latanoprost and timolol to the     individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8     AM, 10 AM, 4 PM at weeks 2, 6 and 12.   "
177184|NCT00159666|"     The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in     patients with post-herpetic neuralgia   "
177185|NCT00159679|"     The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with     painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600     mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the     study.   "
177186|NCT00159692|"     To evaluate the percentage of subjects that reach the diabetic hypertensive blood pressure     goal of <130/80 with amlodipine versus placebo in subjects initially treated with quinapril     or losartan.   "
177187|NCT00159705|"     Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with     neuropathic pain associated with lumbo-sacral radiculopathy.   "
177188|NCT00159718|"     To evaluate and compare the safety and efficacy of amlodipine, atorvastatin and the     combination in patients with symptomatic myocardial ischemia.      Amlodipine's use in angina has been well documented in clinical trials such as the Circadian     Anti-Ischemia Program in Europe (CAPE), but the impact on vascular inflammation in clinical     practice has not been tested. Furthermore, the potentially synergistic benefit of     atorvastatin and amlodipine on inflammation ischemic activity has not been studied.   "
177189|NCT00159731|"     The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional     months to patients who have taken part in the placebo controlled study A0081060; and 2) find     out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)   "
177190|NCT00159744|"     Bipolar disorder is characterized by mood swings that range from high (manic) to low     (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed     episodes). Asenapine is an investigational medication for the treatment of manic or mixed     episodes of bipolar disorder. This is a 3-week study that will test the safety and efficacy     of this medication. Patients will receive either asenapine, olanzapine (a medication that is     already approved for the treatment of bipolar mania), or placebo (no active medication).     Patients will be required to stay in the hospital for at least the first seven days of     treatment. Patients that complete the 3 week study may be eligible to continue in extension     studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.   "
177191|NCT00159809|"     This study will measure the impact of treatment with Viagra on the depressive symptoms and     quality of life in men with erectile dysfunction who have untreated depressive symptoms     meeting the DSM-IV criteria for dysthymia or depression not otherwise specified (NOS),     including minor depressive symptoms but excluding any form of psychotic disorder.   "
177192|NCT00159822|"     To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven     chronic bronchopulmonary aspergillosis, in minimally immunocompromised or     non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary   "
177193|NCT00159835|"     To investigate whether a long-term strategy to lower LDL cholesterol with atorvastatin as     much as possible will improve prognosis in CHD patients compared with a strategy reflecting     current best clinical practice with simvastatin.   "
177194|NCT00159848|"     This study will demonstrate if a treatment optimization program has an impact on the     satisfaction with Viagra treatment in men with erectile dysfunction   "
177195|NCT00159861|"     Determination of the effects of sildenafil citrate and epoprostenol when used in combination     in patients with pulmonary arterial hypertension   "
177196|NCT00159874|"     Active treatment, dose-blinded extension study evaluating the safety and long term efficacy     of sildenafil citrate in children with PAH.   "
177197|NCT00159887|"     Open label extension study to the pivotal efficacy study to assess the safety of sildenafil     citrate in patients with pulmonary arterial hypertension   "
177198|NCT00159900|"     The study objective is to evaluate the effect that sildenafil citrate has on the hardness of     erections in males with erectile dysfunction, based on subject responses to question 5 on the     Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).   "
177199|NCT00159913|"     This is a clinical research study designed to evaluate sildenafil for the treatment of     Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is     to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with     oral sildenafil given in three different doses, compared to placebo (inactive treatment).     Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may     be eligible to take part in an extension study, in which all patients will receive active     treatment of sildenafil.   "
177200|NCT00159926|"     Cardiac surgery using heart and lung machine produces an inflammatory reaction in the body.     This leads in few percent of cases to heart, lung, and kidney disturbances that potentially     causes death. White blood cells in contact with the heart and lung machine and external     surfaces release mediators partly responsible for this. Blood collected by the suction and     the blood remaining in the heart and lung machine after its use, can be cleaned by a cell     saver before reinfusion, and this might reduce the inflammatory response.   "
177201|NCT00159939|"     The purpose of this study is to determine whether prone positioning is effective in improving     survival in patients affected by acute respiratory distress syndrome (ARDS).   "
177202|NCT00159952|"     The purpose of this study is to determine the effect of the intensive insulin therapy on     coagulation and fibrinolysis in patients affected by severe sepsis and septic shock. As a     secondary endpoints the investigators will determine the effect of intensive insulin therapy     on organ dysfunction and mortality of these patients.   "
177203|NCT00159965|"     The investigators propose that treatment of the comorbid disorders (depression, anxiety, and     impulsivity) with sertraline in patients with lone psychogenic nonepileptic seizures (NES),     will result in a decreased number of NES. The purpose of this study is to provide pilot     testing and data to inform the future randomized controlled trial based on the hypothesis.   "
177204|NCT00159978|"     Hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to     radiotherapy in human head and neck tumor cells. Currently, assessment of these two tumor     characteristics is performed in biopsies using immunohistochemical staining and subsequent     analysis. A promising non-invasive method of characterizing a tumor is the use of     positron-emission tomography (PET). Specific tracers can be used to detect hypoxia and     proliferative activity. 18F-misonidazole is a tracer for hypoxia and 18F-thymidine is a     tracer for proliferation.      Patients suffering from head and neck cancer and who will undergo surgery will be included in     this study.      One week before the surgery the patients will undergo a CT-scan and a PET-scan with either of     the tracers. Shortly before the surgery they will be given immunohistochemically detectable     marker substances enabling the characterization of the tumor samples gathered from the     resection specimen. These markers are pimonidazole for detection of hypoxia and     iododeoxyuridine for detection of tumor cell proliferation.      The data collected by PET-scan will be analysed and compared to the results acquired by     immunohistochemistry.   "
177205|NCT00159991|"     There is a remarkable lack of randomized trials concerning the potential benefit of using     arterial conduits for coronary bypass surgery. This is the purpose of the present trial.     Exclusive use of arterial conduits might result in improved conduit viability, reduced risk     of recurrent angina, myocardial infarction and other cardiac events, reduced need for     antianginal medication, improved functional status and possibly improved long term survival.     The patients will be followed for ten years after surgery.   "
177206|NCT00160004|"     Amyotrophic Lateral Sclerosis (ALS) is a progressive neurological disorder characterized by     amongst others asymmetric muscle weakness, respiratory insufficiency and spasticity. The     disease is usually fatal within 2-3 years and until now there is no cure. ALS patients are     usually supported by a multidisciplinary team. One of the members of this team is the     physical therapist. The aim of physical therapy might be to enhance or to preserve     cardiovascular fitness and muscle strength. Some authors suggest, however, that a moderate to     high intensive exercise programme might lead to overuse weakness (an undesired fast     progression of muscle weakness). The primary objective of this study is therefore to     investigate whether regular moderate to high intensity exercise program in ALS can maintain     or optimize cardiorespiratory fitness and muscle strength. A secondary objective is to     investigate whether such a programme leads to overuse weakness and if there is a positive     influence on patient's disability, fatigue and quality of life.   "
177207|NCT00160017|"     The study tests whether implementing professional evidence-based guidelines and best     practices for diabetes care -through participation of multidisciplinary teams in a     Breakthrough collaborative- results in an improvement of diabetes care, its health outcomes     and economic costs. Determinants of success are studied. Data on diabetes will also be used     to better understand Breakthrough as an implementation or improvement method.   "
177208|NCT00160030|"     The primary objectives of this study are to assess the feasibility (completion of full     treatment) in both arms and to assess endoscopic complete response rate in both arms.      The secondary objective of this study is to assess the toxicity profile of each arm using the     National Cancer Institute-Common Toxicity Criteria (NCI-CTC) scale (V.3).   "
177209|NCT00160043|"     The purpose of this study is to determine whether the study drug is effective and safe in the     treatment of patients with non small cell lung cancer who have already received one platinum     based chemotherapy.   "
177210|NCT00160056|"     Hypoglycaemia unawareness is a common complication in patients with type 1 diabetes and with     insulin-treated type 2 diabetes of long duration. The loss of autonomic symptoms to     hypoglycemia does not solely depend on loss of adrenaline responses.Differences in     sensitivity to catecholamines may also be involved.      Reconciling the data on β2-adrenergic receptor polymorphism to those on loss of β-adrenergic     sensitivity in diabetic patients with hypoglycemia unawareness, we hypothesize that     hypoglycemia unawareness is at least partly the result of desensitization of the     β2-adrenergic receptor and that patients who are homozygous for arginine at codon 16 are     particularly susceptible for this desensitization process, whereas patients who are     homozygous for glycine at codon 16 are resistant for desensitization.      Objectives        1. To determine whether, and if so to what extent, antecedent hypoglycemia reduces          β2-adrenergic sensitivity in healthy subjects with Arg16 homozygosity.        2. To investigate whether or not healthy subjects with Gly16 homozygosity are resistant to          desensitization        3. To confirm that antecedent hypoglycemia reduces the heart rate response to isoproterenol          and to assess to what extent this reduced response is mediated by impairments in          baroreflex sensitivity.   "
177211|NCT00160069|"     Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in     patients with stage IIIb or stage IV non-small-cell lung cancer.   "
177212|NCT00160082|"     The primary objective was to assess the effect of Xepol compared to placebo on physical     health and on muscle strength in subjects with post-polio syndrome.The secondary objective     was to assess the effect of Xepol compared to placebo on functional balance, activity     patterns, pain, fatigue, sleep, vitality, muscular strength, pulmonary capacity, walking     ability, balance and safety.   "
177213|NCT00160095|"     The purpose of this study is to identify in a prospective manner microregional profiles of     oxygenation and proliferation based on exogenous and endogenous markers that are predictive     for outcome of radiotherapy in squamous cell carcinoma of the larynx and to investigate if     these profiles can identify patients that are most likely to benefit from hypoxia modifying     treatment strategies like ARCON (Accelerated radiotherapy combined with carbogen breathing     and nicotinamide).   "
177214|NCT00160108|"     Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat,     low-carbohydrate and Mediterranean diet) for weight loss   "
177215|NCT00160121|"     The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis     level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and     to determine the patient and physician's satisfaction.   "
177216|NCT00160134|"     The study is a randomized, placebo controlled, multi-center, single dose study to evaluate     cardiac hemodynamics and safety of iv SLV320 in 110 subjects with congestive heart failure     requiring diuretic treatment. Each subject will receive one dose of SLV320 or placebo or     furosemide. The study consists of three visits (or study days when in-subjects are included).     Ambulatory subjects will be in hospital for two nights and one day.   "
177217|NCT00160147|"     This is a 10-week study with bifeprunox and placebo in elderly subjects with psychosis and     behavioral disturbances associated with dementia of the alzheimer's type.   "
177218|NCT00160160|"     This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus     ramipril/HCTZ.   "
177219|NCT00160173|"     This study is intended to establish the lowest effective dose of EstroGelÂ® for the treatment     of vasomotor symptoms associated with menopause.   "
177220|NCT00160186|"     The purpose of this study is to investigate BMI and the nutritional parameters of Creon     (pancreatin) versus placebo after a total or subtotal gastrectomy.   "
177221|NCT00160199|"     To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in     women of reproductive age with secondary amenorrhea   "
177222|NCT00160212|"     This study is to compare the efficacy and safety of increasing doses of SLV306 with     amlodipine.   "
177223|NCT00160225|"     This study is to evaluate the end of treatment effect of Daglutril compared to placebo on top     of losartan.   "
177224|NCT00160238|"     This study is to compare the effects of Betaserc 24mg and placebo on compensation of postural     and locomotor deficits (static and dynamic posturography) after vestibular neurotomy in     patients suffering from disabling Menière's disease.   "
177225|NCT00160251|"     The primary objective of this study is to determine the safe and effective dose range of     boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic     hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy     with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin     provides an additional benefit when combined with PEG-Intron plus boceprevir.   "
177226|NCT00160264|"     This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the     efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0.5 g compared to     lactulose placebo 15 ml + vitamin D 400 U + calcium 1 g in bone mass preservation among     postmenopausal women.   "
177227|NCT00160277|"     The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian     subjects.   "
177228|NCT00160290|"     To demonstrate that lactulose acts as a stool softener, relieving the pain at defecation,     improving the number of defecations and regulating the colonic transit time in patients     suffering of hemorrhoids or anal fissure. To compare efficacy and quality of life in patients     treated either with lactulose or plantago ovate.   "
177229|NCT00160303|"     The purpose of the research is to study the effects of two different injection therapies for     the treatment of lateral epicondylitis (tennis elbow). Specifically, we will look at which     therapy provides better short and long-term relief of pain, which treatment allows better     function and less disability, and which treatment gives back better strength in the affected     hand. Each subject will receive only one of the two treatments. Although both of these     treatments are usually very well tolerated, it is important to make this comparison because     it is believed that one of these therapies may have better long term effectiveness, with a     lower cost, and smaller number of potential side effects.   "
177230|NCT00160316|"     The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg     estradiol and 2.5 mg dydrogesterone.   "
177231|NCT00160329|"     The study is looking to compare the impact of lipid levels and HIV viral loads between three     different drug regimens: Continuing current regimen (ritonavir boosted regimen), Switching to     Atazanavir, or Switching to Atazanavir in combination to Ritonavir.   "
177232|NCT00160342|"     This is a research study to evaluate the effectiveness, safety and side effects of several     dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and     in combination compared to a placebo (a tablet with no active drug in it) as a possible     treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and     testosterone are two hormones which are typically deficient in menopausal women   "
177233|NCT00160355|"     Wiskott - Aldrich syndrome (WAS) is a rare disorder curable only through allogeneic     hematopoietic stem cell transplantation. A mismatched family member is an option when no     human leukocyte antigen (HLA-immune system type) matched related or matched unrelated donor     is available.      This study will evaluate a novel therapeutic strategy for patients with WAS who undergo     haploidentical transplantation using a parental donor. To reduce the risk of     transplant-related toxicities, participants will receive a reduced intensity chemotherapy and     antibody regimen (conditioning treatment). Participants will then receive an infusion of     donor stem cells depleted of certain white blood cells called T- and B-lymphocytes. The stem     cell depletion processing will be done through the use of the investigational CliniMACS     device. A certain number of T-lymphocytes will be added back to the processed stem cell graft     prior to infusion into the recipient.      The primary objective of this study is to determine the safety of haploidentical     transplantation in WAS patients using this specified conditioning regimen and engineered     graft. Safety will be defined in terms of engraftment (meaning how well the graft grows and     functions after infusion) and regimen-related toxicity within the first 100 days after     transplant.   "
177234|NCT00160368|"     The purpose of this study is to determine the effect of potassium chloride and potassium     bicarbonate on blood pressure and also to determine whether increasing potassium intake has     beneficial effects on the surrogate markers of target organ damage in cardiovascular disease,     as well as on bone health.   "
177235|NCT00160381|"     The objective of this study is to determine the safety and effectiveness of asoprisnil in     symptomatic women with abnormal uterine bleeding associated with uterine fibroids.   "
177236|NCT00160394|"     Comparing the efficacy and safety of a gel formulation containing a combination of     clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily     with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to     moderate severity.   "
177237|NCT00160407|"     The purpose of this study is to determine if orlistat (Xenical) therapy in overweight     patients with NASH leads to enhanced weight loss over time, with subsequent improvement in     the underlying necroinflammatory and fibrotic changes that are typical of NASH.   "
177238|NCT00160420|"     The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12     months in women with endometriosis from study M01-398.   "
177239|NCT00160433|"     The objective of this study is to determine the safety and efficacy of 3 asoprisnil doses     (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.   "
177240|NCT00160446|"     The objective of this study is to determine the safety and effectiveness of three doses of     asoprisnil, compared to placebo, in the treatment of women with endometriosis.   "
177241|NCT00160459|"     This study was designed to determine the safety and effectiveness of 3 asoprisnil doses     compared to placebo, taken for 12 weeks by women with uterine fibroids.   "
177242|NCT00160472|"     This study will evaluate the expression of arginine vasopressin (AVP) by peptide and mRNA     quantitation and also measurement of its V1 receptor mRNA, in the arteries and veins of     ovarian malignant (cancerous) or benign (non-cancerous) tissue. The investigators will     examine whether AVP protein and AVP and V1 receptor mRNA expression vary with respect to     tumor histology, intratumoral vascularization and systemic blood pressure.   "
177243|NCT00160485|"     The purpose of this study is to determine whether the oral administration of glyburide is as     effective as insulin in the treatment of gestational diabetes.        1. SYNOPSIS: Infants born to mothers with gestational diabetes(GDM) are at risk for a          variety of adverse perinatal outcomes including macrosomia with subsequent birth trauma          and cesarean delivery, neonatal hypoglycemia, polycythemia, jaundice, hypocalcemia,          respiratory depression and newborn intensive care unit admission. These adverse outcomes          are thought to be related to the degree of maternal hyperglycemia during pregnancy.          Women with GDM are typically treated with insulin to lower blood glucose levels to as          near-normal as possible. A single randomized trial has suggested that the oral          sulfonylurea, glyburide is a clinically effective and safe alternative to insulin          therapy.        2. Many obstetric care providers have adopted the use of glyburide in the routine          management of gestational diabetes. The American College of Obstetrics and Gynecology          and the American Diabetic Association both state that further studies are needed in a          larger patient population before the use of newer oral hypoglycemic agents can be          supported for use in pregnancy.        3. STATUS: Previous studies have demonstrated that there is no maternal-fetal transfer of          glyburide and when compared to insulin is an effective alternative to insulin.          Additionally, a published cost analysis concluded that glyburide is significantly less          costly than insulin for the treatment of GDM. The benefits of an oral agent for the          management of gestational diabetes include less discomfort for the patient in drug          administration, lower requirement for patient education in the administration of          injectable medications and less chance of error in dosing. Our study population is more          ethnically diverse and our incidence of large for gestational age infants is lower than          in the largely Hispanic population studied by Langer et al. Many obstetricians,          including ourselves, apply different criteria than Langer for diagnosing gestational          diabetes , and for deciding when to institute insulin therapy. It is our goal to confirm          the prior single study concerning the safety and efficacy of glyburide in reducing the          complications of GDM utilizing a more ethnically diverse population with more realistic          goals in glycemic control. To this end we will add to the medical literature supporting          this alternative therapy to insulin.   "
177244|NCT00160498|"     A double blind study to examine the safety and efficacy of different dosages of lercanidipine     in normal weight and obese patients with hypertension   "
177245|NCT00160511|"     16 week trial assessing the efficacy, safety, and tolerability of levetiracetam compared with     placebo in the treatment of postherpetic neuralgia.   "
177246|NCT00160524|"     An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with     Crohn's Disease who have completed a 26-week blinded study (CDP870-031 [NCT00152490] or     CDP870-032 [NCT00152425]).   "
177247|NCT00160537|"     Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as     measured by the subject's satisfaction/dissatisfaction after one week of treatment   "
177248|NCT00160550|"     This study will assess the efficacy, safety, and tolerability of adjunctive treatment with     LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in     reducing PGTC seizures in subjects (4 - 65 years) suffering from idiopathic generalized     epilepsy uncontrolled despite treatment with one or two concomitant AEDs.   "
177249|NCT00160563|"     Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic     Children).      36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing     the onset of asthma in young atopic children.   "
177250|NCT00160576|"     This is a 41-week trial composed of two consecutive parts (Part A, 14 weeks and optional Part     B, 27 weeks) to evaluate the efficacy of levetiracetam in controlling levodopa induced     dyskinesias in adults with Idiopathic Parkinson's Disease, without negative impact on the     benefit on the motor function of the antiparkinsonian treatment.   "
177251|NCT00160589|"     Two weeks study to evaluate the efficacy and safety of Levocetirizine and Desloratadine in     patients suffering from Allergic Rhinitis (AR)   "
177252|NCT00160602|"     A 24 week study in which patients are given study medication and assessed for signs and     symptoms of rheumatoid arthritis. X-rays are performed to assess the progress of joint damage     during the study.   "
177253|NCT00160615|"     The safety and efficacy of L059 will be evaluated in patients who completed N165 Clinical     Trial of L059. They will receive L059 at a daily dose from 1,000 mg to 3,000 mg in addition     to their standard concomitant AEDs   "
177254|NCT00160628|"     A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam     as adjunctive therapy in partial epilepsy.      Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.   "
177255|NCT00160641|"     An open ended study in which patients who completed the preceding double-blind study     NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid     Arthritis.   "
177256|NCT00160654|"     Community based study assessing safety and efficacy of levetiracetam in partial onset     seizures.      The optimal dose in daily clinical practice will be used.   "
177257|NCT00160667|"     Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic     neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor     down-titration.   "
177258|NCT00160680|"     Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on     demand, measured by evolution of individual symptom scores during 6 months.   "
177259|NCT00160693|"     The primary purpose of this study is to obtain long-term safety data with CZP in patients     with Rheumatoid Arthritis (RA). Additional objectives are to assess the dose and type of     Arthritis medication(s) utilized by patients, and to assess the long-term impact of CZP on     physical function. Treatment will continue up to approval of a marketing application for this     product.   "
177262|NCT00160732|"     The purpose of this study is to determine the safety of transplanting human islet cells for     controlling hyperglycemia in brittle and/or complex patients with type 1 diabetes. In     addition, initial observations will be made with regards to the effectiveness of reversing     hypoglycemia with this treatment. The Edmonton Protocol of using specific anti-rejection     drugs without steroids is also being evaluated.   "
177263|NCT00160745|"     The endothelium plays an important role in the regulation of vascular tone and regulation of     blood flow. Nitric oxide (NO) is the most important known endothelium-derived vasodilating     factor. Prospective studies have shown that hypercholesterolemia impairs endothelial function     in different vascular beds. Lowering total cholesterol and particularly LDL-cholesterol with     statins leads to an improvement in endothelium-dependent vasodilation in the forearm     vasculature. There is strong evidence to suggest that the benefit is not merely related to     the decrease in cholesterol-levels. A recent study in the forearm vasculature demonstrated     that short-term lipid-lowering therapy improves endothelial function and NO availability     already after 3 days of lipid lowering therapy. Whether endothelial function in the renal     vasculature of hypercholesterolemic patients is similarly influenced has not yet been     addressed adequately. In the present study we investigate whether lipid lowering therapy with     rosuvastatin alters renal endothelial function, as assessed by systemic infusion of the NO     synthase inhibitor L-NMMA, after 3 and 42 days of therapy.   "
177264|NCT00160758|"     This purpose of this study is to measure the strength of tissue allografts that have been in     the body various lengths of time.   "
177265|NCT00160771|"     The purpose of the data bank is to collect data on joint motion.   "
177266|NCT00160784|"     The purpose of this study is to compare two treatments used for treating frozen shoulder     which are arthroscopy and forceful stretching of the shoulder and home stretching therapy to     see if one relives pain and improves shoulder motion more quickly. The other purpose is to     try and understand what causes frozen shoulder. For this purpose, tissue will be taken from     the shoulder during surgery and studied for the presence and level of a protein called     cytokine (Connective Tissue Growth Factor)   "
177267|NCT00160797|"     The purpose of this study is to gather information about total knee replacement surgery using     minimally invasive surgical procedures.   "
177268|NCT00160810|"     The purpose of this study is to collect information about how people do after different     treatments of a broken wrist to see if one treatment has better results.   "
177269|NCT00160823|"     The quality of colon cleansing has a major impact on efficiency and cost of colonoscopy. A     hand-out was made to instruct and motivate patients to adequately clean the bowel before     colonoscopy.      The aim of the study is to compare adequacy of bowel cleansing in hospitalized patients     receiving the hand-out or not on the day before colonoscopy.   "
177270|NCT00160836|"     Introduction In patients with a biliary obstruction, tissue is acquired immediately before     drainage during endoscopic retrograde cholangio-pancreatography (ERCP). This is performed by     passing a brush inside the bile duct stricture. However, brush cytology has a modest     sensitivity (30-57%) for the diagnosis of cancer. A device, called the G.I.U.M. catheter,     allows for the sampling of higher amounts of tissue during ERCP compared to brush cytology.     The aim of this study is to compare the diagnostic yield of tissue sampling performed in     patients with a suspected malignant biliary stricture using 2 techniques, namely a standard     brush catheter and the G.I.U.M..      Protocol design Eligible patients will have tissue sampling performed using both techniques     during ERCP, the first technique used being randomly assigned and immediately followed by the     other one as well as biliary decompression. All specimens obtained will be subjected to     cytopathological examination. After inclusion of the total number of patients, smears will be     anonymized and analyzed for diagnosis, cell cellularity and quality. The final clinical     diagnosis in each case will be based on cytologic results plus histological examination of     biopsy specimens.   "
177271|NCT00160849|"     1. Objectives Primary             -  To investigate the possibility of maintaining virological suppression of HIV in               infected patients, switching them to LPV/r as the only antiretroviral agent             -  To assess the immunological response in patients who switched to LPV/r as single               agent, based on the observation of changes in the serum levels of CD4+ cells.           Secondary             -  To investigate the rate of clinical and laboratorial adverse events in the two               treatment groups.             -  To investigate the rate of emergence of antiretroviral resistance mutations in the               two treatment groups, in case of virological failure of the current regimen.             -  To describe the adherence to the prescribed regimen in the two treatment groups             -  To describe changes in body fat distribution (abdominal, arms and thigh               circumference) and in the lipid profile, in patients from the two treatment groups             -  To describe the rate of clinical failure of the antiretroviral therapy in the two               treatment groups.        2. Patient population:           The 60 patients were selected by the investigators according to the study’s inclusion          and exclusion criteria, and were divided into 2 groups with 30 patients each.        3. Study design:           The study is multicentric, open-label, randomized. Virological, immunological and          clinical failures will be analyzed in both groups. In addition, data on clinical or          laboratorial toxicity and compliance are being recorded.        4. Regime:             -  Group 1 maintenance of the currently used antiretroviral therapy             -  Group 2 switch to LPV/r antiretroviral monotherapy in the dose of 400/100 mg 12/12               hs with food. Patients in group 2 who were being treated previously with               non-nucleoside reverse transcriptase inhibitors (Efavirenz or Nevirapine) were               instructed to take 4 capsules of Lopinavir/r each 12 hs, during the first 14 days               of therapy (up to Week 2 visit).        5. Duration:      96 weeks of treatment   "
177272|NCT00160862|"     The primary objective is to determine the effect of a single oral dose of 250 mg SLV 317 on     substance P-induced venodilation in the hand vein of healthy male volunteers as compared to     placebo.   "
177273|NCT00160875|"     Cancer of the esophagus is a very serious cancer. Studies have shown that using chemotherapy     and radiation before surgery is the most promising treatment approach, with one quarter to     one half of tumors shrinking by 50% or more in size after chemotherapy and radiation. In     patients who have a very good response to this treatment, survival following esophagectomy     has increased, although the amount of increase has varied quite a bit between the different     studies. Older studies have used the drugs Cisplatin and 5-fluoruracil. Although this     combination of drugs has been beneficial, we wish to use a newer combination of drugs which     may be more effective for esophageal cancer. The chemotherapy drugs used in this study are     Cisplatin and Irinotecan. We also want to find out what side effects these drugs cause when     given with radiation, and how often these side effects occur.   "
177274|NCT00160888|"     The objective of the study is to assess the impact of genetic variation (especially     polymorphisms of the gene coding endothelial nitric oxide synthase (eNOS) and the bradykinin     B2 receptor gene) on venous and arterial responsiveness to vasodilators in healthy     individuals without cardiovascular risk factors.   "
177318|NCT00161460|"     The purpose of this study is to determine if a prototype colorectal cancer screening program     with the services of a cancer prevention specialist will increase utilization of appropriate     colorectal cancer screening tests.   "
177275|NCT00160901|"     The purpose of this study is to determine wether a complementary therapy consisting of a     combined medication of selenium, milk thistle, goldenrod and bromelain and a consultation     concerning nutrition and physical activity can reduce side effects of a chemotherapy in     breast cancer patients.   "
177276|NCT00160914|"     Childhood obesity has been described as a growing national epidemic. Between 1980 and 1994     the prevalence of childhood obesity doubled with 10% to 15% of children and adolescents being     obese. Childhood obesity has both immediate and long-term detrimental consequences for health     and well-being. Obese children are at increased risk for coronary heart disease, type 2     diabetes, and hypertension. Obese children are more likely to be at risk for psychological     stress and disturbed body image. Moreover, obese children are more likely to become obese     adults, especially if weight reduction has not occurred by the end of adolescence.      The pediatrician is in an ideal position to assess and manage childhood obesity. Recently,     guidelines have been established for the assessment and treatment of childhood obesity. These     best practice guidelines include recommended diagnostic criteria, assessment of     contributing factors such as diet and lifestyle, family history, and treatment choices.     Although these guidelines have been introduced little is known about pediatricians' actual     practice patterns and their beliefs concerning childhood obesity.      Project Description I plan to conduct a national survey of pediatricians to assess common     strategies for the identification and management of childhood obesity, along with     pediatricians' attitudes and beliefs about childhood obesity. In consultation with a panel of     practicing general pediatricians and survey research experts, I plan to develop a survey that     measures pediatricians' beliefs about the causes and consequences of childhood obesity, its     prevalence in their practice settings, their approaches to diagnosis and management, and     resources available for treatment. The survey will be administered to a randomly selected     national sample of approximately 600 practicing general pediatricians. The response rate is     expected to be approximately 60% or 360 pediatricians. The survey results will help to assess     the degree to which recommended practice guidelines are being implemented, identify     pediatricians' beliefs and attitudes that might serve as barriers to optimal care, and     suggest areas for continuing medical education. The proposed time frame for the study is two     years.   "
177277|NCT00160927|"     Vascular and neurological mechanisms are both likely to be involved in foot ulcer. We     recently reported on the hand an original transient pressure-induced vasodilation (PIV)     during a 5 mmHg/min increase of pressure strain using laser Doppler flowmetry. This     physiological response to non noxious external local pressure strain is a widely protective     cutaneous mechanism. The impairment of PIV in diabetic subjects may be relevant to the high     prevalence of foot ulcer that occurs in these individuals. The aim of the project is to     analyse the different physiopathological processes involved in PIV impairment in diabetic     subjects as compared to matched controls.   "
177278|NCT00160940|"     The purpose of this research is to study body materials like blood proteins as well as white     blood cell and liver cellular RNA in individuals with liver diseases such as chronic viral     hepatitis with or without hepatoma and autoimmune liver disease. Presently it is not     understood how infection with chronic viral hepatitis or autoimmune liver disease damages the     liver. This research study enroll patients with either chronic viral hepatitis with or     without hepatoma or autoimmune liver disease.      The purpose of this study is to find the genes that are expressed in both the circulating     white blood cells and the liver of patients with varying degrees of liver damage of different     causes. Genes are biological messengers some of which determine how the body responds to     injury. We anticipate that results from Differential Gene Expression (DGE) analysis will     allow us to make predictions about likelihood of disease progression and/or response to     treatment.      In addition we will test the blood for markers of injury. The blood collected will be     prepared differently from the liver tissue. We will use technologies to express pure proteins     and then we will investigate the functions of these proteins. Nearly all drugs act on     proteins, not genes, so understanding proteins is the key to really effective new medicines.     Similarly the first signs of ill health appear in changes to the body’s blood proteins,     making them the most sensitive diagnostic indicators. The studies we plan are called     proteomics.      We will later correlate the patterns of gene expression in both circulating white blood cells     and the liver tissue with clinical outcome and patterns of proteins measured in blood and we     hope to gain an understanding of how the disease process occurs, which may in turn help us to     make more precise diagnoses and develop new forms of treatment.      These techniques that we use are still experimental and so we do not yet know if they will be     helpful in monitoring changes which may help us to predict the potential severity of your     liver disease or even if they can be used to indicate who will best respond to treatment.   "
177279|NCT00160953|"     When we acquired MR images of the prostate gland using a coil (receiver antenna) inside the     rectum, we can see areas with tumour in the prostate gland, and well as details of the     anatomy. The coil inside the rectum changes the shape of the prostate gland. In order to use     this images to help target radiation therapy to the tumour better, we need to deform the     images to the original shape of the prostate gland without the coil. In this study, we will     develop a way to deform the images accurately.   "
177280|NCT00160966|"     The aim of this study is to characterize and evaluate risk factors of polyomavirus     nephropathy (PVN) including the impact of three immunosuppressive regimens.   "
177281|NCT00160979|"     Prostate cancer is now the most commonly diagnosed tumor among men in the United States. Most     patients have tumors that are confined to the prostate gland at diagnosis and are suitable     for treatment with surgery or radiotherapy (RT) that is aimed at curing the disease.     Nevertheless, despite recent improvements in these treatments, a large number of men continue     to die of prostate cancer. These patients often have spread of tumor to other areas of the     body, and are treated with hormones that produce initial tumor shrinkage. However, over time     the tumor learns to grow despite continued hormonal treatment. Effective therapy for patients     with hormone-resistant prostate cancer is lacking and patients often deteriorate quickly and     die. Thus, there is a need for better treatment that cures prostate cancer at an early stage,     and a better understanding of the biology of prostate cancer specifically with respect to     factors that determine the effectiveness of RT, the spread of tumor and the development of     hormone-resistant disease.      Low levels of oxygen (hypoxia) are known to exist in many human tumors, and studies have     shown that hypoxic tumors are less likely to be cured by RT. In addition, hypoxia may lead to     lower cure rates following surgery, spread of cancer to other areas of the body, and changes     in the genetic characteristics of the cancer cells that cause them to behave more     aggressively.      The importance of hypoxia in prostate cancer has not previously been evaluated. The aims of     this study are to determine how often hypoxia occurs in early prostate cancer and whether     hypoxia influences the success of RT, tumor spread beyond the prostate to bones and other     organs and the development of hormone-resistant disease. Patients will have tumor oxygen     levels measured using a special fine-needle electrode system prior to beginning treatment     with either RT or the combination of hormones plus RT. The measurements will be made through     the rectum using ultrasound to position and guide the electrode. A biopsy of the tumor will     be obtained at the site of the measurements, and this will be used to determine how oxygen     influences changes in the genetic character of prostate cancer cells. A total of 195 patients     will be evaluated in this way over 3 years.      This study will provide unique information about the behavior of prostate cancer, which may     help explain why currently available treatments including surgery, RT and hormones fail to     cure patients. Assuming that this study shows hypoxia to be important in prostate cancer,     future work will focus on new anti-hypoxia treatments to be used in combination with surgery     or RT with the aim of overcoming this obstacle and improving cure rates.   "
177282|NCT00160992|"     Patients with advanced stage melanoma who underwent vaccination with the Melan-A/MART-1     peptide and who display detectable levels of Melan-A specific CD8+ T cells in peripheral     blood are eligible for this trial. After collecting and freezing of these tumor specific T     cells via apheresis, patients undergo a single cycle of immunosuppressive chemotherapy. 3     days after, cells are reinfused and peptide vaccination continued. The aim of this     immunotherapy protocol is to boost tumor specific T cells during the immune recovery period     in order to reinforce the patients' immune response against the tumor.   "
177316|NCT00161434|"     The primary objective of this research study is to assess if daily valacyclovir therapy for     suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in     individuals co-infected with both HSV-2 and HIV.   "
177319|NCT00161473|"     The purpose of this study is to see if a medication called prazosin is useful in the     treatment of agitation and aggression in persons with Alzheimer's disease (AD) and other     types of dementia in late life.   "
177283|NCT00161005|"     In the district areas of Norway patients with acute myocardial infarction with ST-elevation,     are treated with thrombolysis. An increasing part of them receives thrombolysis before     arrival to the local hospital.Usually these patients have been sent to an invasive center if     thrombolysis fails or the patient gets ischemic symptoms during the stay.      This study will compare this strategy against immediate transportation to an invasive center     after the patient has received thrombolysis.   "
177284|NCT00161018|"     The purpose of this study is to:        1. Evaluate the efficacy and safety of the new antipsychotics, quetiapine (300-500mg/day)          and risperidone (3-4mg/day) compared to each other and to fluphenazine (10-15mg/day), a          high potency typical antipsychotic in patients who meet the DSM IV criteria for          schizophrenia.        2. To evaluate the efficacy and safety of quetiapine (1200mg/day) in patients who have not          responded to conventional and newer antipsychotics.        3. To evaluate the effectiveness of quetiapine (300-500mg/day), and risperidone (3-5mg/day)          compared to each other and fluphenazine (10-15mg/day) in the treatment of hostility and          aggression in treatment-resistant schizophrenic patients.        4. To evaluate the effectiveness of quetiapine (300-500mg/day) and risperidone (3-5mg/day)          compared to each other and fluphenazine (10-15mg/day) on rates of discharge, quality of          life, and independent living skills.        5. To assess prolactin levels and to evaluate any relationship with sexual dysfunction and          menstrual irregularities.        6. To evaluate the possible differential impact of treatment conditions on cognitive          functioning including measures of attention, motor speed, problem solving, verbal and          visual memory, and verbal processing speed.        7. To measure changes in weight and health consequences associated with weight changes.   "
177285|NCT00161031|"     The purpose of this study is to:        -  To examine wether adjunctive atomoxetine is more effective thank placebo for          neuropsychological measures of reaction time, motor speed, psychomotor speed, sustained          attention, learning and memory, working memory, and executive functioning. To determine          the effect size of atomoxetine on these neuropsychological measures for follow-up          studies.        -  To determine if atomoxetine has short-term benefits for improving weight gain and other          metabolic abnormalities associated with antipsychotics.   "
177286|NCT00161044|"     The purpose of this study is to see if galantamine is an effective agent for the treatment of     the cognitive abnormalities, negative symptoms, and /or behavioral impairments seen in     schizophrenia.   "
177287|NCT00161057|"     In this study we, the investigators at UMC Utrecht, intend to investigate changes in brain     activation patterns using functional magnetic resonance imaging (MRI), in patients suffering     from schizophrenia who are medication naive or off medication, before using medication and     after 8 weeks of medication. Patients will perform a working memory task, a language task and     a motor task while lying in the scanner. We hypothesize that the efficiency of the working     memory system is reduced and that the lateralization of language is diminished in these     patients, and that these functions will normalize after treatment.   "
177288|NCT00161070|"     The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a     combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment     with aspirin alone after cerebral ischemia of arterial origin.   "
177289|NCT00161083|"     We conduct a randomized, double-blind, placebo-controlled trial on effects of UDCA on biliary     pain and complications in highly symptomatic gallstone patients scheduled for     cholecystectomy. We also evaluate potential beneficial effects of impaired gallbladder     motility   "
177290|NCT00161096|"     The purpose of this study is to investigate several aspects of chronic use of acid     suppressing medication: dependence on maintenance therapy, the possibilities for on-demand     use, and predictors (patient characteristics) for daily need, for on-demand use and for     termination of chronic use.   "
177291|NCT00161109|"     The purposes of this study are to:        1. study the nature and longitudinal course of psychiatric symptoms in children with the          22q11.2 deletion syndrome and        2. identify genes that contribute to the occurrence of these symptoms.   "
177292|NCT00161122|"     The PRIMAKid trial is a general practice based double-blind randomized placebo-controlled     trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in     pre-school children with recurrent respiratory tract infections. A target number of 660     children aged 18-72 months with a history of two or more general practitioner attended     episodes of RTI, are included. Exclusion criteria are diseases accompanied by a high risk of     recurrent RTI and conditions chronically treated with corticosteroids. Over a period of 7 to     22 months follow-up, the number of febrile RTI-episodes as primary outcome is assessed, and     as secondary outcomes the severity and length of febrile RTI-episodes, medical visits /     interventions, health-related quality of life and productivity loss of parents.   "
177293|NCT00161135|"     This study aims to investigate the overlap and differences between autism and MCDD as     neuropsychiatric childhood disorders. MRI scans are acquired from subjects with autism,     subjects with a diagnosis of MCDD and typically developing controls. Volumetric measure of     various brain regions are compared between groups. We hypothesize that subjects with autism     will have larger brains than controls, whereas subjects with MCDD will have smaller brains.   "
177294|NCT00161148|"     PSC is a progressive liver disease without effective medical treatment. There is often     co-existent ulcerative colitis. Probiotics (bacterial food supplements) have been shown to     benefit patients with ulcerative colitis. In the current protocol potential beneficial     effects of probiotics on liver biochemistry and liver related symptoms as pruritus are being     assessed in 12 PSC patients in a randomized controlled cross over study (3 months probiotics,     1 one wash-out and 3 months placebo).   "
177311|NCT00161369|"     Homocysteine (Hcy) and asymmetric dimethylarginine (ADMA) have recently been recognized as     potential risk factors for atherosclerosis in the general population, and the metabolism of     each of these substances seems to be closely related. This study investigates the association     between these substances, and whether elevated serum levels of Hcy and ADMA would be related     to a high risk of atherosclerosis and cardiovascular events in maintenance hemodialysis (HD)     patients.   "
177312|NCT00161382|"     This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention     program for 7th and 8th grade middle school students.   "
177317|NCT00161447|"     The purpose of this research study is to help in the development of male contraception (birth     control).   "
177295|NCT00161161|"     Attention Deficit Hyperactivity Disorder (ADHD) is a heritable psychiatric disorder with     onset in childhood. Twin and adoption studies indicate that additive genetic factors explain     up to 80% of the variance underlying susceptibility. The siblings of children with ADHD have     a three- to fivefold increased risk of having ADHD compared to the siblings of healthy     control subjects, and the risk is even greater for monozygotic twins with 50-80% concordance     compared with up to 33% in dizygotic twins). As full siblings share on average 50% of their     genes, even the unaffected siblings of children with ADHD would be expected to share some of     the genes involved in the disorder. The neuroanatomical substrate of ADHD is becoming     increasingly better defined by a growing body of evidence from imaging studies. Evidence from     neuroimaging studies suggests that this disorder is associated with reductions in brain     volume up to 5% in these children. In this protocol we collected MRI-scans from boys with     ADHD and their unaffected siblings, as well as control subjects. In addition, cheekswabs were     later collected for DNA analysis.   "
177296|NCT00161174|"     BACKGROUND:      Evidence has emerged that patients cured with cisplatin-bleomycin chemotherapy from     disseminated testicular cancer (TC) develop a large number of cardiovascular risk factors     (CRF) several years later. Recently, we observed an increased incidence of cardiac events     10-20 years after chemotherapy, possibly as a result of increased occurrence of CRF.     Additional cardiovascular damage was observed after treatment: disturbed diastolic function     of the left ventricle, microalbuminuria and increased endothelial damage parameters.     Furthermore, a metabolic syndrome (syndrome X) with insulin-resistance, dyslipidemia,     hypertension and endothelial damage was found in about one third of our cured patients. The     investigators hypothesize that endothelial damage and metabolic changes caused by the     bleomycin and cisplatin chemotherapy are the main causes for the observed increase in     cardiovascular disease in these young cancer survivors. Genetic susceptibility may be an     important determinant of individual risk of toxicity in individual patients.      PURPOSE:        1. To identify risk factors for cardiovascular disease (CVD) following testicular cancer.        2. To obtain insight into the pathway(s) of CVD development, by examining whether clinical          CVD following testicular cancer is associated with a preceding unfavorable          cardiovascular risk factor profile and/or with treatment-related factors.        3. To investigate genetic polymorphisms in pathogenetically important pathways that are          potentially involved in the development of treatment related cardiovascular morbidity          following testicular cancer.      PATIENTS AND METHODS:      Patients with non-seminomatous testicular cancer who have been uniformly treated with     orchidectomy and cisplatin-bleomycin combination chemotherapy at the University Hospital     Groningen, The Netherlands, since 1977 but before 2000 are eligible. 380 patients with     non-seminomatous testicular cancer fulfill these criteria. A close routine follow-up of these     patients after treatment has been done at the University Hospital Groningen. Clinical     characteristics of these patients, treatment details including outcome and long-term     follow-up are being registered systematically. From all patients who agree to participate     assessment of their cardiovascular risk factors and the presence of subclinical     cardiovascular damage will be performed by means of several measurement techniques. Also     genomic DNA will be collected for studies on polymorphisms in pathogenetically important     pathways. For the total cohort of patients several different late effects phenotypes of     cardiovascular damage and cardiovascular risk factor patterns will be derived from the     available data. These toxicity phenotypes will be used to select cases and controls from the     total cohort to test candidate genetic polymorphisms on their association with occurrence of     toxicity. The association of the different genetic polymorphisms with the toxicity phenotype     will be estimated by comparing cases with different toxicity phenotypes with controls without     that phenotype.      POSSIBLE RESULTS This research will provide insight into the pathogenesis of cardiovascular     disease after treatment for testicular cancer. The main outcome will be the possibility to     select individually those patients who are likely to have an increased risk to encounter     specific cardiovascular toxicity during or after chemotherapy treatment for TC. This will     provide opportunities for the tailoring of potential toxic treatment and/or guide primary and     secondary prevention strategies for serious side effects of chemotherapy treatment.   "
177297|NCT00161187|"     RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may     help the patient's immune system kill cancer cells.      PURPOSE: This pilot study is looking at the side effects and how well irradiated donor     lymphocyte infusion works in treating patients with relapsed or refractory hematologic cancer     or solid tumor.   "
177298|NCT00161200|"     In this project, we are trying to identify patients with the earliest signs of abnormality in     the lining of the lower part of the food pipe (or esophagus) known as intestinal metaplasia     (IM); also commonly called Barrett's esophagus or Barrett's Epithelium (BE). IM is sometimes     difficult to diagnose by routine microscopic examination (called histology). We have     developed a specific antibody, a protein called immunoglobulin that specifically reacts with     another partner protein, if it exists. Using this marker antibody (called mAb Das-1) that has     been patented (US patent #5,888,743), we have shown that this marker can detect the abnormal     changes in the distal esophagus before it is evident by histology. IM usually develops in the     face of long-term acid reflux from the stomach to the esophagus and causes the lining to     change from the normal squamous type (like that of skin) to a type of lining normally seen in     the small intestine and colon. A subgroup of patients with IM may, subsequently, develop     histologically evident Barrett's Epithelium and a small percent of these patients may develop     cancer of the esophagus. Thus, BE is considered as a pre-cancerous condition. We already have     an ongoing IRB for the portion of the project involving taking biopsies and performing the     antibody staining to identify patients that react with the antibody but histologically     negative for BE.   "
177299|NCT00161213|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib     mesylate works as first-line therapy in treating patients with locally advanced or metastatic     pancreatic cancer.   "
177300|NCT00161226|"     Endometrial (uterine) cancer affects over 40,000 women each year in the United States. At     this time there are no medications to prevent endometrial cancer. Women who are heavy are at     increased risk of this cancer. Progestins have been used to treat endometrial hyperplasia and     cancer in women who wanted to retain their fertility or who were not surgical candidates.     Oral progestins are associated with side effects such as weight gain, mood changes,     headaches, and acne. A device called Mirena has a type of progesterone in it. Because it is     placed directly in the uterus it can give a powerful amount of progestin with less side     effects. In this project, we will enroll 44 women who are aged 40-50 and who have a body mass     index (BMI) greater than 40. (BMI is a measure of obesity. Normal is less than 25.) They will     be randomized to either observation or treatment. The women in the treatment group will have     a levonorgestrel intrauterine system (Mirena, LNG-IUS) placed for one year. All of the women     will have endometrial biopsies and blood work at the beginning and end of the study. All of     the women will have an ultrasound at the beginning of the study. The information will then be     used to assess whether or not the LNG-IUS will be an effective prevention agent. The women     will be contacted once a year for 5 years to see if they have had endometrial hyperplasia or     cancer. A special lab study called microarray will be used to see what genes are turned on or     off in the uterine lining.   "
177301|NCT00161239|"     Peripheral T cell lymphoma and advanced cutaneous T cell lymphomas are aggressive and     refractory diseases that are generally treated with chemotherapy. Despite current treatment     modalities, only a subset of patients will be cured by the treatment. In this study, four     chemotherapeutic agents (L-asparaginase, Methotrexate, Doxil, and Prednisone) will be     administered in a combination regimen for patients with relapsed or refractory Peripheral     and/or advanced cutaneous T cell lymphoma. Each one of these individual drugs have been shown     to have activity to lymphomas. The objective of the study is to determine if the combination     of these chemotherapy agents results in higher response and cure rates in this patient     population. This will be a single institutional study which will included 32 patients in the     Peripheral T cell lymphoma group and 32 patients in the Cutaneous T cell lymphoma group.   "
177313|NCT00161395|"     The purpose of this study is to determine how long it takes couples of normal fertility to     get pregnant once they begin to try, and whether instruction in fertility awareness can     decrease time to pregnancy in these couples.   "
177314|NCT00161408|"     The study is a randomized clinical trial investigating the efficacy of a comprehensive     psychological intervention for the treatment of first episode schizophrenia   "
177315|NCT00161421|"     The purpose of this study is to test the how the body absorbs and processes new forms of oral     testosterone. Information gained during the study may help develop better forms of     testosterone therapy in the future.      We will be administering three drugs. Dutasteride is FDA approved to treat prostate     enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved     for treatment of testicular insufficiency. They are being used in this study for off-label     research purposes. This study will allow us to find out the effect of food on two     formulations of testosterone taken by mouth, and the relative effect of food on testosterone     absorption.      Information from this study may be useful in treatment of men with low testosterone levels     and the development of a male hormonal contraceptive.   "
177302|NCT00161252|"     The widespread availability of screening coupled with high risks of over diagnosis, over     treatment, and a rising risk of dying from competing causes of deaths pose a major challenge     for prostate cancer patients and our health care system. Data on outcomes and identification     of patients who are likely to benefit from therapies are urgently needed to empower patients     and health professionals and to allocate limited health resources wisely. The long-term goal     of this population-based study is to improve prostate cancer care for elderly patients. In     2004, approximately thirty percent of the 230,110 new prostate cancer cases diagnosed will be     in men over age 75. Elderly men have a high risk of being diagnosed with prostate cancer, but     a relatively low risk of dying of this disease, and are often excluded from cancer trials.     While the value of primary androgen deprivation for localized prostate cancer remains     questionable, this treatment is widely used among elderly patients. Currently, there is     insufficient outcomes data to guide treatment choices for elderly patients.The following are     the key background considerations that provide the rationale for this proposed project:·     Prostate cancer is prevalent among elderly men. · Over diagnosis and competing causes of     death are important issues for elderly men with prostate cancer.· Androgen deprivation     therapy (ADT) is being increasingly used as primary therapy among elderly patients with     localized disease· There are insufficient outcomes data to support the use of primary     androgen deprivation for non metastatic prostate cancer· Preliminary dataThe study population     in this sub-project is a sub-sample of the large study (IRB # 5177 ) and the research methods     are identical in both studies.   "
177303|NCT00161265|"     This study is being performed so that tumor and blood samples from patients who will receive     breast cancer treatment prior to surgery can be collected and stored for future research.   "
177304|NCT00161278|"     Patients who are at least 18 years of age and have a type of cancer known as advanced     non-small cell lung cancer may be eligible for this study if they meet all of the     inclusion/exclusion criteria.      Background: The standard treatment for patients with advanced non-small cell cancer is     chemotherapy. The two drug combination, carboplatin (Paraplatin) and paclitaxel (Taxol), is     commonly used as the first treatment. Unfortunately, standard treatment with chemotherapy     only shrinks the cancer in about 30% of patients that receive it. There is no way to predict     who will or won't benefit from this treatment. The researchers at the University of Michigan     would like to determine if the genes of the lung cancers in patients enrolled in this study     will help predict whether or not the tumors shrink when exposed to standard chemotherapy. The     goal is to find a set of lung cancer genes that will predict successful treatment with     carboplatin and paclitaxel in patients with non-small cell lung cancer.      The actual treatment, carboplatin and paclitaxel, involved in this study is not experimental.     The experimental aspect of this study is the identification of predictors of response to     treatment. To do this, it would require a sample of your cancer. If your initial surgery or     biopsy was done at the University of Michigan, we may already have an adequate sample of your     cancer that could be used for this research. In that case, we are asking for your permission     to use this sample for this study. However, if you meet all eligibility criteria and agree to     participate in this research study and an adequate sample is not available, you will need to     undergo another biopsy procedure for us to obtain a sample of your cancer. Obtaining a tumor     sample is the most crucial part of this research study.   "
177305|NCT00161291|"     The purpose of this study is to determine pathological response to a maximum of 18 weeks of     neoadjuvant therapy using a combination of letrozole and Bevacizumab in post-menopausal women     with pathologically confirmed invasive ductal cancer or invasive lobular cancer of the breast     whose tumors are hormone positive.   "
177306|NCT00161304|"     The T-001 study is a placebo-controlled investigation of the effects of injectable     testosterone replacement therapy on prostate tissues of aging men with low testosterone     levels. The primary objectives of the study are to measure the changes in tissue hormones and     other biomarkers in the prostate tissue specimens.   "
177307|NCT00161317|"     The Living with Hope program was developed by the research team, a panel of experts and     palliative patients and their families. The program was evaluated with 60 advanced cancer     patients 60 years of age and older. Thirty received the program and 30 did not. After one     week, those receiving the Living with Hope Program had higher hope and quality of life scores     compared to those who did not. This suggests that the program is effective in increasing hope     and quality of life for older palliative care patients with cancer.   "
177308|NCT00161330|"     The main objectives of the study are        1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a          first episode of UTI        2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram,          voiding cystourethrogram, and renal scanning with technetium-99m-labeled          dimercaptosuccinic acid)   "
177309|NCT00161343|"     In this study, an intervention is tested that is designed to reduced risky sexual behaviors     in adolescent females. Study design:        -  randomized, controlled study        -  participants: 640 girls aged 15-19 years old        -  length of follow-up: 1 year after the intervention is completed      Study hypothesis: The experimental condition will significantly reduce risky sexual behaviors     in adolescent females as measured by:        -  lower incidence of STI's at 6 and 12 months, as compared to baseline        -  decreased incidence of risky sexual behaviors        -  increased knowledge of the level of risk of certain behaviors        -  increased knowledge of safer sexual behaviors that can prevention HIV infection        -  increased motivation to reduce sexual risk        -  increased behavioral skills to reduce risk of HIV infection   "
177310|NCT00161356|"     In this study we are trying to find out the amount of a drug called Ambisome in the liver,     the blood, the bile and the fatty tissues of the body. This drug is approved for treatment of     infections caused by fungus and is known to be effective against most of the fungal     infections, which can happen after liver transplantation. By taking small pieces (less than     quarter of a teaspoon) of liver and fat during the liver transplant operation, we can measure     how much of the drug is concentrated in the liver. After that, we will measure the level of     the drug in the blood and in the bile that comes out of a small tube which is inserted into     the bile tube as a routine in all liver transplant patients. These measurements will be taken     daily for a week and then weekly for another 3 weeks.      We are inviting you to take part in this study in order to increase our knowledge of the     behavior of this drug so that we can find the most effective treatment to prevent fungal     infections in liver transplant patients.   "
177320|NCT00161486|"     The purpose of this research study is to understand the effects of testosterone on the     prostate. This knowledge will be used to help in the development of a safe male hormonal     contraceptive and may impact the development of androgen replacement therapy in older men.   "
177321|NCT00161525|"     Subretinal hemorrhage in the macula causes a significant loss of vision. This hemorrhage can     be displaced by the use of a small volume of pure perfluorocarbon gas injected into the     vitreous, which expands to a 40% gas bubble in the eye. When the patient gazes 40 to 60     degree below the horizontal, the gas bubble covers the hemorrhage and gravity displaces it     rapidly. This position of gaze is easier for the patient than the face down position     traditionally recommended.A vector of gravity force tangential to the sclera brings about     this displacement. The procedure can improve vision quickly, reduce unwanted degenerative     changes in the macula because of the persistent macular hemorrhage and improves the chances     of treating of the underlying cause for the subretinal hemorrhage by laser or other means.   "
177322|NCT00161538|"     The purpose of this study is to determine which of 4 lead positions is most effective for     pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial     fibrillation.   "
177323|NCT00161551|"     The purpose of this study is to determine the incidence of atrial fibrillation and heart     failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel     algorithm to minimize ventricular pacing).   "
177324|NCT00161564|"     The purpose of this research study is to compare the efficacy and safety of higher doses of     rituximab to a combination of standard doses of Rituxan + CVP (Cyclophosphamide, Vincristine,     and Prednisone) in patients with chronic Idiopathic Thrombocytopenic Purpura (ITP who did not     respond to or relapsed after standard doses of rituximab.   "
177325|NCT00161577|"     This study evaluates the safety and efficacy of ketorolac for post-operative pain management     after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing     the requirements for morphine during the (immediate) 24-hour post-operative period.   "
177326|NCT00161590|"     Primary Objective:        -  To determine the toxicity profile and tolerability of alemtuzumab (Campath) when          administered in combination with cyclophosphamide, doxorubicin, vincristine, and          prednisone (CHOP) chemotherapy (C-CHOP) in patients with T-cell, null-cell and NK-cell          lymphomas.      Secondary Objectives:        -  To evaluate response rate, overall survival, and disease-free survival in patients with          T-cell, null-cell, and NK-cell lymphomas treated with Campath + CHOP chemotherapy.        -  To assess the incidence of cytomegalovirus (CMV) reactivation in patients with these          lymphomas treated with the Campath + CHOP combination.        -  To determine features which might be predictive of resistance to treatment or predictive          of relapse, including the absence of glycosylphosphatidylinositol (GPI)-linked proteins.   "
177327|NCT00161603|"     To explore and illuminate the cultural, social, and psychological factors that either     facilitate or serve as barriers to behavioral change in angioplasty patients. Through a     series of open-ended questions we will explore and build a better understanding of how     culturally different patient groups perceive heart disease and the difficulties in changing     health behavior. In addition, we hope to better understand and anticipate barriers and issues     that participants face in successfully changing their behaviors.   "
177328|NCT00161616|"     Demonstrate a larger proportion of subjects with healed fractures among subjects treated with     InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed,     locked intramedullary nailing alone.   "
177329|NCT00161629|"     To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal     radius fractures. The key safety variables comprising this assessment are: 1) incidence of     delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence     of local neurovascular events (those involving the region under study [RUS]); and 4) rate of     fracture displacement. The primary objective will be met if these outcomes in the active and     placebo treatment groups are at least comparable to those of the SOC control group.   "
177330|NCT00161642|"     The purpose of this study is to determine the safety, tolerability and maximum tolerated dose     of CMD-193. Preliminary information about how a person's body processes CMD-193 and how     CMD-193 affects tumors will also be collected.   "
177331|NCT00161655|"     The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in     plaque psoriasis patients, treated with the combination etanercept and methotrexate compared     to etanercept alone.   "
177332|NCT00161668|"     This study is designed to assess the safety of Mylotarg therapy in routine practice.   "
177333|NCT00161681|"     The purpose of this study is to determine whether LNG/EE is effective in the treatment of     menstrual cycle related symptoms.   "
177334|NCT00161694|"     The purpose of this study is to see if an oral sucrose solution can comfort premature infants     during their necessary eye exams. The investigators believe that the use of this solution     prior to the eye exams will lead to a decrease in pain as measured by a rise in heart rate     and a fall in oxygen saturation. In addition this will lead to a decrease in events in the 12     hours following examination. Events include episodes when the infants temporarily stop     breathing, have a drop in their heart rates, or have a drop in their oxygen levels.   "
177335|NCT00161707|"     The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the     short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with alpha     1-antitrypsin deficiency. The subjects are randomized to receive placebo or one of 4 doses of     rAAT. The 4 doses are tested in a consecutive manner from lowest to highest.   "
177336|NCT00161720|"     This is a data collection study with the purpose of capturing dosing and treatment outcome     data in subjects with severe congenital protein C deficiency who were treated with protein C     concentrate under an Emergency Use Investigational New Drug Application (IND).   "
177337|NCT00161733|"     The objective of this study is to demonstrate equivalent hemostatic efficacy and safety     between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery     requiring cardiopulmonary bypass. If bleeding is still present after conventional surgical     methods to achieve hemostasis have been applied FS VH S/D or Tisseel VH are applied.     Achievement of hemostasis within 5 minutes is compared between the study groups.   "
177338|NCT00161746|"     The purpose of this study is to evaluate a) whether the seroconversion rates in children are     equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5     mL, and b) whether there is a difference in terms of safety between the two products.   "
177339|NCT00161759|"     The purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as     staples (the current standard of care) to achieve fixation of skin grafts and wound healing     in subjects with burn wounds. Each subject receives staples as well as FS 4IU on comparable     treatment sites.   "
177340|NCT00161772|"     The purpose of this study is to investigate the safety and immunogenicity of three different     concentrations of a TBE vaccine in healthy children aged 1 to 6 years.   "
177341|NCT00161785|"     The purpose of this study is to assess:        -  TBE antibody persistence 2 and 3 years after the third TBE vaccination with FSME-IMMUN          0.5ml by means of ELISA and neutralization test (NT).        -  TBE antibody response to a booster vaccination with FSME-IMMUN 0.5ml, by means of ELISA          and NT.   "
177342|NCT00161798|"     The purpose of this study is to investigate the safety and immunogenicity of three different     concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.   "
177343|NCT00161811|"     The objectives of the study are to assess the immunogenicity and safety among three different     lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day     180 after vaccination.   "
177344|NCT00161824|"     The purpose of this study is to assess the safety of a vaccination schedule consisting of two     vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW     (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with     polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.   "
177345|NCT00161837|"     The objectives of the study are to assess the immunogenicity and safety of the inactivated     influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.   "
177346|NCT00161850|"     The purpose of this study is to investigate the safety and immunogenicity of the third     vaccination with one of three different concentrations of a TBE vaccine in all subjects who     completed two vaccinations in one of the three treatment groups of Baxter study 199 (a     dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME     IMMUN NEW in healthy subjects aged 1 to 6 years).   "
177347|NCT00161863|"     The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN     NEW in healthy volunteers. The main criterion for investigation is the fever rate after the     first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN     NEW has been demonstrated in previous clinical studies in children; therefore, in the present     study, immunogenicity was investigated in a subgroup only.   "
177348|NCT00161876|"     The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW     in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME     IMMUN NEW and ENCEPUR in healthy volunteers aged 16 to 65 years).   "
177349|NCT00161889|"     The purpose of this study is to investigate the safety and immunogenicity of the third     vaccination with one of three different concentrations of a TBE vaccine in all volunteers who     completed two vaccinations in one of the three treatment groups of Baxter study 205 (safety     and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy volunteers aged 6 to 16     years).   "
177350|NCT00161902|"     The purpose of the study is to monitor the safety of FS VH S/D and evaluate whether FS VH S/D     is superior to standard treatment in reducing blood loss in subjects undergoing total hip     replacement with cement-free hip prostheses.   "
177351|NCT00161915|"     The purpose of this study was to assess whether endoscopic sclerotherapy with Fibrin Sealant     was superior to ligature, with or without Polidocanol, in achieving hemostasis in bleeding     esophageal varices and preventing rebleeding. Therapeutic success was defined as survival of     the first seven days without clinically significant bleeding.   "
177352|NCT00161928|"     The primary aim of the study is to show that NeisVac-C does not influence the seroconversion     rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP)     vaccines in infants.   "
177353|NCT00161941|"     The primary aim of the study is to show that the antibody response to hepatitis B, acellular     pertussis toxin and inactivated poliovirus antigens after the 4th vaccination with Hexavac®     is not influenced by the concomitant administration of NeisVac-C.   "
177354|NCT00161954|"     The objective of this study is to establish the earliest time point at which vaccines are     expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using     a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.   "
177355|NCT00161967|"     The purpose of this study is to assess the seropersistence of TBE antibodies in children and     adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34     months after completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations     during the predecessor study 209), as well as the immune response to a booster vaccination     with FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml administered 36 months after the third     vaccination (in Study 209).      Protocol amendment of October 2006: The study has been prolonged for children and adolescents     who still showed highly positive TBE virus antibody concentrations at approximately 3 years     after the third vaccination and therefore did not receive a booster vaccination at this time     point. Further follow-up of TBE antibody persistence is now included for these subjects at 46     and 58 months after the third vaccination (in Study 209), as well as a booster vaccination     offered at either 48 or 60 months after the third vaccination (in Study 209), depending on     individual TBE antibody levels.   "
177356|NCT00161980|"     This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is     superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing     the axillary lymphatics in subjects undergoing lumpectomy and level I and II axillary lymph     node dissection with two separate incisions.   "
177383|NCT00156507|"     Children born less than 1500 grams are being enrolled into a study to test the effectiveness     of a parental educational intervention in reducing the risk of future breathing problems. The     intervention teaches parents of these children how to reduce the risk of / and recognize     breathing problems.   "
177357|NCT00161993|"     The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune     Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with     primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are     treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects     receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product;     for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.   "
177358|NCT00162006|"     The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR     (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic     idiopathic thrombocytopenic purpura.   "
177359|NCT00162019|"     The purpose of this study is to evaluate whether IMMUNATE S/D is effective and safe in the     treatment of hemophilia A patients. The study consists of 3 parts: Part 1 is a     pharmacokinetic comparison of IMMUNATE S/D and its predecessor IMMUNATE. Part 2 is an     evaluation of efficacy and safety of IMMUNATE S/D. Part 3 is a pharmacokinetic study of     IMMUNATE S/D.   "
177360|NCT00162032|"     Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging     (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of     developing cardiac events.   "
177361|NCT00162045|"     The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and     safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.   "
177362|NCT00162058|"     To determine the optimal dose of DMP 115 to image liver lesions and to assess whether     contrast can improve the detection of focal liver lesions.   "
177363|NCT00162071|"     The primary purpose of this study is to determine the optimal time for myocardial perfusion     imaging with Technetium Tc99m Sestamibi following the administration of BMS068645. The safety     of BMS068645 will also be studied.   "
177364|NCT00162084|"     The purpose of the study is to determine whether BMS068645 is as effective as Adenosine SPECT     at detecting blockages in heart arteries, and to determine if it will have fewer side effects   "
177365|NCT00162097|"     The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz     (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable     antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or     normal hepatic function.   "
177366|NCT00162110|"     This is a Phase II open-label trial evaluating the efficacy, and safety of Erbitux in     patients with mucinous gastrointestinal adenocarcinoma involving the peritoneal surface.   "
177367|NCT00162123|"     The purpose of this study was to evaluate the continued use of ipilimumab in patients who had     reinduction at the time of disease progression or to continue maintenance treatment. In     addition, this study will continue to follow patients who have taken ipilimumab, but who are     not eligible for maintenance or reinduction therapy.   "
177368|NCT00162136|"     The purpose of this study is to determine the dose limiting toxicities, minimum tolerated     dose and recommended dose for Phase II studies.   "
177369|NCT00162149|"     Open-Label, multiple-dose, drug interaction study to assess the effect of nevirapine on the     pharmacokinetics of atazanavir in HIV-infected individuals.   "
177370|NCT00162175|"     A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the     Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type     2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.   "
177371|NCT00162188|"     This study is being conducted to assess the safety and tolerability of an oral liquid     solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected     children between the ages of 3-16 who are failing or intolerant of their current     antiretroviral regimen and who are unable to swallow Sustiva capsules.   "
177372|NCT00162201|"     Study to assess changes in synovial tissue before and after treatment with Abatacept in     subjects with RA who remained on their background disease modifying anti-arthritis     medications but who have failed previous therapy with anti-TNF (tumor necrosing     factor)blocking agents.   "
177373|NCT00162214|"     The purpose of Segment 1 of the study is to determine the effect of ketoconazole on     dasatinib. The purpose of Segment 2 is to learn how dasatinib affects tumor growth in     patients with advanced solid tumors.   "
177374|NCT00162227|"     This study is being conducted to assess the safety and tolerability of an oral liquid     solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected     children between the ages 3-16 who are failing or intolerant of current antiretroviral     regimen and who are unable to swallow Sustiva capsules.   "
177375|NCT00162240|"     A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the     Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type     2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone   "
177376|NCT00162253|"     The purpose of this clinical research study is to learn if BMS-587101 is effective on the     treatment of Moderate to Severe Psoriasis. The safety of this treatment will also be studied.   "
177377|NCT00162266|"     This study was conducted to assess the safety and tolerability of Abatacept combined with     Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives     were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept     combined with Methotrexate.   "
177378|NCT00162279|"     The Study was designed to look at the safety and efficacy of abatacept in combination with     etanercept.   "
177379|NCT00162292|"     The purpose of this clinical research study is to learn if it is safe for rheumatoid     arthritis patients to take BMS-582949 along with methotrexate.   "
177380|NCT00162305|"     The purpose of this clinical research study is to assess the safety of, exposure to, and     biological effects of BMS-512148 in stable Type 2 diabetic subjects   "
177381|NCT00156481|"     This study involves in-depth interviews with parents of urban children with asthma and focus     groups with additional parents in order to understand their attitudes and beliefs about     smoking.   "
177382|NCT00156494|"     This study involves telephone surveys of parents of young urban children with and without     asthma to assess attitudes about smoking including personal smoking bans in their homes and     cars, and beliefs about public policies regarding smoking.   "
177384|NCT00156520|"     It is known that patients with aortic stenosis, including those undergoing cardiac surgery     for this problem, are prone to developing bleeding problems, particularly of the     gastrointestinal tract. It is believed that the shear stress associated with blood flow     through the abnormal aortic valve results in abnormal hemostasis. Abnormalities include     increased proteolysis of the von Willebrand factor (vWF) and increased binding of the high     molecular weight multimers of vWF to platelet membranes with subsequent inappropriate     platelet aggregation. Thus, appropriate aggregation of circulating platelets is impaired.     Cardiac surgery is associated with significant alterations in hemostasis. Patients undergoing     cardiac surgery consume a significant percent of available blood products throughout the     United States and are subjected to various and numerous risks associated with blood product     transfusion. In addition, excessive postoperative bleeding is a common cause for the need to     surgically re-explore the chest cavity in patients who have just undergone cardiac surgical     procedures. Such additional surgery carries further cost and risk. Following surgical     correction of aortic valve stenotic pathology, associated vWF abnormalities appear to     reverse. However, this process can take several days. Although all cardiac surgical patients     are at risk for postoperative bleeding, patients undergoing aortic valve surgery for aortic     stenosis may be particularly at risk for this postoperative complication. In addition,     patients with aortic valve stenosis who undergo noncardiac surgery may have a predisposition     to bleeding because of similar underlying shear stress induced abnormal vWF and platelet     function. The proposed study is a trial to evaluate the effectiveness of 2 different     antifibrinolytic drugs in ameliorating the hemostatic defect associated with aortic stenosis.     Aprotonin, an antifibrinolytic agent which also has platelet preserving actions4, will be     compared to the currently used anti-fibrinolytic, epsilon aminocaproic acid (EACA).   "
177385|NCT00156533|"     We want to assess whether how and when one takes sleep medication results in similar or     different outcomes with respect to symptom relief. We also want to know whether taking     medication for a period of time provides continued benefit once the medication is stopped.   "
177386|NCT00156546|"     Our hypothesis is that long-term antimicrobial prophylaxis does not reduce the recurrence of     infection and the risk of appearance of kidney scars in children with a documented previous     upper UTI.   "
177387|NCT00156559|"     This research is designed to address the question, Does the relative deficit in vaccine     immunogenicity in extremely premature infants persist beyond the first 6 months of life? We     propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in     relatively healthy, 12-to-15 month-old children born at <29 weeks gestation, when compared to     full-term infants, as measured by the relevant viral serologies.   "
177388|NCT00156572|"     Hydrochlorothiazide and spironolactone are diuretics that are commonly in preterm infants     with bronchopulmonary dysplasia (BPD). Hyponatremia (low blood salt) is a common side effect.     It is uncertain whether the best way to treat the hyponatremia is by oral salt     supplementation or restricting fluid intake. Our hypothesis is that fluid restricted infants     will be better able to preserve the beneficial effects of diuretics on the lungs. The study     will include very low birth weight infants (VLBW) 400-1500g from Hermann Memorial Children's     Hospital NICU or LBJ General Hospital NICU with BPD. They will be enrolled and randomly     assigned to either the salt supplementation group or the fluid restriction group once they     become hyponatremic (defined as serum Na <130). The study intervention will take place for     four weeks. The primary outcome will be assessed by comparing the patient's initial oxygen     and breathing machine requirements with those at the end of the four-week study period.   "
177389|NCT00156585|"     Hypothesis: the pattern of MRI contrast enhancement after gadolinium injection is different     in tumors that respond well to gamma knife.      We are going to acquire sequential T1-weighted images of brain lesions before, during and     after injection of Gd-DTPA. This will be repeated before and after a treatment with gamma     knife. We will then analyse our results to see if there are common enhancement     characteristics between lesions that will respond well to the radiosurgery treatment.     Response will be clinically assessed by tumor volume as determined by MRI approximately 4 to     6 months after treatment.   "
177390|NCT00156598|"     Other research studies have shown that the levels of metals in the blood are slightly     increased after patients receive a total hip replacement. We want to learn whether these     elevated levels are associated with any adverse effects. We hope this study will help us     identify which type of patients have elevated levels of metal in their blood.   "
177391|NCT00156611|"     The Rio Study is a randomized, double blinded German- Swiss- Austria multi-centre trial on     the efficacy and safety of ReoPro together with interventional recanalization of TASC D     lesions in the SFA and popliteal artery.   "
177392|NCT00156624|"     The Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre     study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and     popliteal artery.   "
177393|NCT00156637|"     The goal of this project is to translate research findings about key aspects of antipsychotic     treatment into routine care through a multi-component intervention, focusing on improving two     aspects of medication management that are directly linked to patient outcomes: 1) monitoring     for potentially serious metabolic side effects of newer antipsychotic medication, and 2)     increasing the appropriate use of clozapine for treatment-refractory patients.   "
177394|NCT00156650|"     This study is being offered to all participants of the ACY-5 study as an optional addition to     the male contraceptive study in which they participated. Participation is voluntary.      The purpose of this added procedure (Testicular Aspiration-HOP 3) is to determine the amount     of testosterone (male hormone) in the testes of men who are on a male contraceptive regimen.   "
177395|NCT00156663|"     The purpose of this study was to develop and evaluate an educational program intended to     raise staff awareness about women veterans and their health care needs and preferences.   "
177396|NCT00156676|"     The primary purpose of this study is to collect preliminary and pilot data to begin to     determine whether the use of body weight support treadmill therapy (BWSTT) with and without     driven-gait-orthotics (DGO), results in improved motor recovery and ambulation MS patients     with gait impairment   "
177397|NCT00156689|"     Considering the mechanisms of action which provide efficacy in epilepsy, it is hypothesized     that treatment with levetiracetam will reduce the neuronal excitability involved in     neuropathic pain associated with CIAP. Thus, there is a potential for levetiracetam to bring     therapeutic benefit for the subjects because of its specific mechanism of action, its safety     profile and the absence of interaction with other drugs.   "
177651|NCT00167921|"     The purpose of this study is to characterize the systemic exposure and bioavailability at     steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in     postmenopausal women with atrophic vaginitis.   "
177628|NCT00165867|"     The overall purpose of this study is to determine the efficacy, safety and tolerability of     indisulam in combination with irinotecan as a treatment for patients with metastatic     colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).   "
177398|NCT00156702|"     The primary hypothesis of this pilot study is that dependence can be prevented in adolescents     who smoke, but who are not yet dependent. With this study, we seek to develop and test the     feasibility and provide controlled comparisons of two brief smoking dependence-prevention     interventions: motivational interviewing with feedback versus a video control. Forty     adolescents between the ages of 12 and 18 will be enrolled. The evaluation and     dependence-prevention phases will occur during a single 3- to 4-hour session, and the 30-45     minute follow-up sessions will take place approximately one month, three months, six months,     and one year after the completion of the evaluation and dependence prevention phases.   "
177399|NCT00156715|"     The purpose of this study is to examine the efficacy of quetiapine (Seroquel) in reducing     substance use in persons diagnosed with schizophrenia. The primary hypothesis is that     quetiapine treatment will be associated with a decrease in substance use.   "
177400|NCT00156728|"     The purpose of the study is to characterize atrial arrhythmias in patients indicated for     Cardiac Resynchronization Therapy (CRT) and to monitor changes in atrial arrhythmias while     CRT is provided.   "
177401|NCT00156741|"     The purpose of this study is to provide evidence that the Refined Ventricular Pacing     Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of     ventricular pacing.   "
177402|NCT00156767|"     An appropriate hypothalamic-pituitary-adrenal (HPA) axis response is required to survive     critical illness. Primary adrenal insufficiency, relative adrenal insufficiency, tissue     resistance to glucocorticoids, ACTH deficiency and immune-mediated inhibition of the HPA axis     may impair the secretion or action of glucocorticoids in critically ill patients. Adrenal     insufficiency is estimated to occur in up to 77% of critically ill patients, but currently,     there is no consensus on the diagnostic criteria for adrenal insufficiency in this setting,     and standard testing does not discriminate among the aforementioned factors. We will study     the incidence and natural history of adrenal insufficiency in critically ill patients to     further define adrenal insufficiency and provide data to develop diagnostic tests. Clinical     features and outcomes will be correlated with laboratory measurements of hormones, cytokines     and glucocorticoid action. Healthy volunteers will undergo cortrosyn tests with measurement     of free cortisol levels to develop a normative range for this endpoint.      <TAB>      Previous glucocorticoid use, if prolonged and supraphysiologic, also inhibits the HPA and can     result in adrenal insufficiency. Patients with short intermittent courses of glucocorticoid     administration have not been studied well, and may also be at risk. To gain further     information about this group, patients receiving pulse glucocorticoid doses as part of bone     marrow transplant regimens at the Clinical Center will also be studied.   "
177403|NCT00156780|"     This study was conducted to evaluate the safety and pharmacokinetics of an echocardiographic     contrast agent, AI-700, in patients with moderate to severe chronic obstructive pulmonary     disease (COPD) and/or congestive heart failure (CHF).   "
177404|NCT00162318|"     The purpose of this study is to find a safe and effective dose of Erbitux and Iressa for     subject with non small cell lung cancer.   "
177405|NCT00162331|"     The purpose of this clinical study is to learn if there are any changes in how blood gets to     your heart muscle and if your heart size changed after your heart attack.   "
177406|NCT00162344|"     The study is designed to see if stress heart imaging can be used as a screening exam in     patients with diabetes and risk factors of developing of coronary artery disease and     experiencing future cardiac events.   "
177407|NCT00162357|"     The purpose of this clinical research study is determine if patients with diabetes that have     undergone previous opening of a heart blockage may have a blockage that is not causing any     symptoms that may be detected by imaging with Cardiolite.   "
177408|NCT00162370|"     The study is designed to see if stress echocardiography can be used as a screening exam in     peri-, or post-menopausal women with a risk of developing of coronary artery disease and     experiencing future cardiac events.   "
177409|NCT00162383|"     The ability to metabolize drugs varies greatly among individuals. Major fraction of this     variability lies in genetic polymorphisms of genes encoding for enzymes responsible for both     phase I and phase II reactions.      The purpose of this study ws to evaluate the phenotypic activity and the frequency of genetic     polymorphisms in different phase II and phase I enzymes among various populations residing in     Israel.   "
177410|NCT00162396|"     The response to salbutamol varies greatly among individuals. Data from previous studies     indicate that some of the variability is accounted for by genetic polymorphisms in the gene     encoding for the adrenoceptor subtype β2. The current study was designed to evaluate     variability in the response to salbutamol among recently diagnosed patients who have not been     treated by β2 agonists or corticosteroids.      Lung function tests will be performed prior to and following a single dose administration of     salbutamol through inhalation. Additional pharmacodynamic indices will be monitored including     pulse and blood pressure. Three samples of plasma will be drawn for the evaluation of     salbutamol plasma concentration.   "
177411|NCT00162409|"     Folic acid supplementation has been shown previously to be associated with enhanced formation     of p-HPPH from phenytoin, a metabolic pathway which is predominantly mediated through the     activity of CYP2C9.      The metabolism of S warfarin, the more active enantiomer of warfarin, is also mediated     predominantly through the activity of CYP2C9.      The purpose of the present study was to examine the relationship between folic acid     concentration and warfarin pharmacokinetic as well as warfarin dose requirement among     patients treated by warfarin. In addition the effect of folic acid supplementation (5 mg/d)     for 3 weeks on warfarin pharmacokinetic and warfarin dose requirement will be evaluated in     the second part of the study.   "
177435|NCT00163345|"     The aim of this study is to evaluate the involvement of small airways in asthma, as     determined by bronchial challenges, CT-scanning, and cellular markers of inflammation.     Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a     baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide     further data on safety and tolerability of ciclesonide.   "
177436|NCT00163358|"     The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of     fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients     with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a     treatment period (12 months). The study will provide further data on safety and tolerability     of ciclesonide.   "
177412|NCT00162422|"     The role played by ß2AR polymorphisms in determining the bronchial response to ß2AR agonist     drugs, has been confirmed by several studies.      The purpose of the present study is to examine possible causal relationships between     genetically based alteration in the structure of ß2AR and drug responsiveness. An ex-vivo     model (organ bath technique) will be used to investigate association between polymorphisms in     the coding region of ß2AR and the response of bronchial rings derived from human lung tissue     to the respective agonists (i.e. salbutamol).      In the second part of the study the same bronchial rings will be incubated for 24 hours in a     solution containing fixed concentration of albuterol. A second dose response curve for rising     concentrations of albuterol will be constructed and a relationship between β2 genetic     polymorphisms and the extent of desensitization to albuterol will be investigated.      In addition, through specifically designed receptor binding assay the bronchial tissue will     be used to define the affinity (Kd) and expression (Vmax) of the ß2 receptor. These data will     enable to enhance our understanding regarding the mechanism responsible for the association     noted between ß2AR polymorphism and altered drug effect.   "
177413|NCT00162435|"     The response to warfarin varies greatly among individuals. Some of this variability can be     ascribed to genetic polymorphisms in the gene encoding for CYP2C9, the enzyme mediating the     metabolism of S warfarin. In addition genetic polymorphism in other genes (i.e. VKORC1,     factor VII) have been shown to account for some of the variability in the response to     warfarin irrespective of CYP2C9.The present study has several segments:        1. Evaluation of the relationship between genetic polymorphisms in the genes encoding for          CYP2C9, VKORC1 and factor VII and warfarin maintenance dose at steady state. This study          is a confirmation of previous data in our own population.        2. Evaluation of relationship between genetic polymorphisms in the genes encoding for          CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period.        3. Testing the hypothesis that warfarin loading based on the individual's combined CYP2C9,          VKORC1 and factor VII genotype may be more efficient and associated with reduced adverse          drug effects.   "
177414|NCT00162448|"     Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of     BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators   "
177415|NCT00162461|"     The use of phenytoin metabolism to produce S-HPPH accounts for more than 85% of its     metabolism. This metabolic pathway is mediated by the activity of CYP2C9.      The purpose of the present study is:        1. To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity        2. To correlate phenytoin metabolic ratio with CYP2C9 genotype        3. To study the frequency distribution of CYP2C9 activity in-vivo   "
177416|NCT00162474|"     The anticoagulant effect of warfarin varies greatly among individuals. Some of this     variability is attributed to differences in the activity of CYP2C9, the predominant enzyme     involved in the metabolism of S-warfarin.      The present study is designed to define the differences in warfarin metabolism among healthy     individuals carrying different CYP2C9 genotypes. In addition, the study will define the     correlation between the phenytoin metabolic ratio, a marker of CYP2C9 activity in vivo, and     warfarin metabolism.   "
177417|NCT00162487|"     Several studies have indicated that albuterol administered either intravenously or by     inhalation can significantly reduce plasma potassium concentration in patients suffering from     chronic renal failure.In conjunction with the decrease in potassium concentration a modest     rise in glucose concentration is usually noted. These metabolic effects are characterized by     rapid onset occurring as early as 3-5 minutes following salbutamol administration and lasting     for at least 1 hour.      The role played by ß2AR polymorphisms in determining the bronchial and vascular response to     ß2AR agonist drugs, have been confirmed by several studies.      The purpose of the present study is to examine possible causal relationships between     genetically based alteration in the structure of ß2AR and the metabolic effects of inhaled     albuterol.   "
177418|NCT00162500|"     Rationale:      ImMucin was shown to be able to induce a robust cellular immune response mediated via both     CD4+ and CD8+ T lymphocytes and therefore, could potentially be more effective in the     majority of the target population.      Purpose:      The purpose of this study is to evaluate the safety and initial efficacy of ImMucin, a novel     peptide vaccine in metastatic tumors expressing the MUC-1 Tumor Associated Antigen (TAA).   "
177419|NCT00162513|"     Donors with CM will be solicited from a waiting list of patients awaiting BMT from the     waiting list of MUD searches.      Maximally matched donor will be searched for each eligible CML patient with a goal in mind to     find other patients with CML that share both class I and class II determinants. Sharing of     one class I II will be considered eligible for participation in the study. Peripheral blood     and PBMC from the donors will be isolated, washed and irradiated.      The cells will be injected into the consenting patients intracutaneously at 2 weeks intervals     for a total of 6 injections.   "
177420|NCT00162526|"     The present protocol is an attempt to prevent/treat mucositis in highly susceptible patients     subjected to maximally tolerated doses of subsequently-myeloablative or myeloablative doses     of chemoradiotherapy supported by autologous or allogeneic stem cell transplantation at the     Department of Bone Marrow Transplantation. Mucositis is a major problem in the management of     transplant recipients which subjects the patients to the risk of sepsis, need for parenteral     nutrition and need of narcotics. We are planning a 2 arm study, comparing 2 safe vitamin E     based formulations with placebo.   "
177421|NCT00162539|"     Mother with severe Iodine deficiency are more likely to have neonates with further poor     mental development . In order to select population which could benefit from iodine     supplementation, ioduria has been tested but cannot be routinely practised. Strong background     data suggest that iodine status could be antenatally correlated with foetal thyroid volume.     The aim of that study is to examine correlation between these two parameter in a population     of 130 healthy pregnant women.   "
177437|NCT00163371|"     The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice     daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on     short-term lower leg growth in prepubertal children with mild persistent asthma. The study     duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each     treatment), and a wash-out period (2 weeks). The study will provide further data on safety     and tolerability of ciclesonide.   "
177422|NCT00162552|"     In patients with cirrhosis and liver failure, pro-inflammatory cytokines (TNF alpha) might be     responsible of severe complications and death. Thus, the prevention of cytokine production     should prevent complications and mortality.      The aim of this study is to study the 2 months survival rate in patients with severe     cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6     month mortality, the proportion of transplanted patients, the occurrence of complications     (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding),     plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a     multicenter double blind randomized trial with a placebo.      All adult patients with severe cirrhosis might be randomized after written consent. Patients     with severe carcinoma, intolerance or contraindication to pentoxifylline will not be     included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three     hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in     a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.   "
177423|NCT00162565|"     The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker     continuation compared to its interruption in patients with congestive heart failure who are     treated by a beta-blocker and present with an episode of heart failure worsening with     pulmonary oedema requiring hospital admission.      162 patients will be randomized in cardiology centers in France. Clinical status (primary     endpoint) will be evaluated with a standardized questionnaire 3 days after hospital     admission.   "
177424|NCT00162578|"     Adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal     meningitis in adults. Use of dexamethasone as adjunct therapy has proved to reduce mortality     and neurologic sequelae in adult patients with pneumococcal meningitis. However, use of     dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. In a purely     observational manner, we thought to measure blood and CSF concentrations of vancomycin in     adult patients with pneumococcal meningitis, treated with vancomycin, third-generation     cephalosporin and dexamethasone.   "
177425|NCT00162591|"     The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral     index variation during a nociceptive stimuli.   "
177426|NCT00162604|"     Prolapse of the uterus, bladder and rectum is a common condition in multiparous and/or     elderly women. The number of operations for vaginal repair is increasing in Denmark, but     there is no consensus or evidence found about the efficiency of prophylactic antibiotics     intraoperatively concerning postoperative infections.      The objective of this randomized, controlled trial is to investigate the significance of     prophylactic antibiotic treatment in vaginal repair operations.   "
177427|NCT00162617|"     To examine the effect of two different transfusion regimens on rehabilitation after hip     fracture surgery.   "
177428|NCT00162630|"     To evaluate the analgesic potential of an neural blockade (Fascia iliaca compartment) with     local anaesthetics in patients with hip fracture immediately after arrival in the emergency     department.   "
177429|NCT00162643|"     Ritonavir boosted protease inhibitor based therapy will have equivalent antiviral efficacy     over 48 weeks compared to NNRTI based therapy in patients who are antiretroviral therapy     naïve and initiate therapy with CD4 counts ≤ 200/mm3.   "
177430|NCT00163280|"     This purpose of this study is to investigate whether ATL-104 is safe and well tolerated, and     whether it shows evidence of efficacy in mucositis in patients undergoing PBSCT   "
177431|NCT00163293|"     The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of     the number of asthma exacerbations in children with mild persistent asthma. Treatment     medication will be administered as follows: ciclesonide will be inhaled once daily, using one     of the two dose levels versus placebo together with other corticosteroids used as     intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a     treatment period (12 months). The study will provide further data on safety and tolerability     of ciclesonide.   "
177432|NCT00163306|"     Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and     esophagus. GERD occurs when the lower esophageal sphincter does not close properly and     stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common     medical disorders, with estimates of up to 50% of adults reporting symptoms related to     gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of     GERD in a large proportion of patients.      When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning     sensation in the chest or throat. This sensation is often referred to as heartburn. Some     patients have symptoms of GERD without visible destruction of the tissue surface (no visible     changes by endoscopic examination).      The aim of the study is to evaluate the effect of pantoprazole on the complete remission of     GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief     after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in     the morning. Endoscopy will be performed at the start of the study, and then as required     after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of     pantoprazole.   "
177433|NCT00163319|"     The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone     propionate on the lung function, symptoms, use of rescue medication, and occurrence of side     effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will     be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily     at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment     period (24 weeks). The study will provide further data on safety and tolerability of     ciclesonide.   "
177434|NCT00163332|"     The aim of the study is to investigate the effect of ciclesonide versus fluticasone     propionate versus placebo on airway hyperresponsiveness and on the     hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as     follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the     two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five     treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The     study will provide further data on safety and tolerability of ciclesonide.   "
177522|NCT00164476|"     Project SHIELD (Strategies and health Interventions to Enhance Life with Disability) is a     participatory action research project to test an intervention package combining a resource     kit with peer mentoring in improving consumer education about primary preventive services   "
177438|NCT00163384|"     This trial will compare the effectiveness of one dose of ciclesonide against one dose of     budesonide in patients with asthma.      The aim of the present trial is to compare the efficacy of ciclesonide versus budesonide on     pulmonary function, symptoms and use of rescue medication in patients with asthma. The onset     of action and the safety and tolerability of ciclesonide in comparison to budesonide will     also be investigated.   "
177439|NCT00163397|"     The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung     function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and     budesonide will be inhaled once daily at one dose level each. The study duration consists of     a baseline period (1 to 4 weeks) and a treatment period (12 weeks). The study will provide     further data on safety and tolerability of ciclesonide.   "
177440|NCT00163410|"     The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate     on lung function, symptoms, and use of rescue medication in children with persistent asthma.     Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be     inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to     4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and     tolerability of ciclesonide.   "
177441|NCT00163423|"     The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate     on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue     medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be     inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose     level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a     treatment period (24 weeks). The study will provide further data on safety and tolerability     of ciclesonide.   "
177442|NCT00163436|"     The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung     function and safety. Ciclesonide will be inhaled at one dose level once daily, using an     inhaler device with or without spacer. The study duration consists of a baseline period (1 to     3 weeks) and a treatment period (12 weeks).   "
177443|NCT00163449|"     The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school     children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested     versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a     treatment period (24 weeks). The study will provide further data on safety and tolerability     of ciclesonide.   "
177444|NCT00163462|"     The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate     on lung function, symptoms, and use of rescue medication in children with persistent asthma.     Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone     propionate will be inhaled at one dose level twice daily. The study duration consists of a     baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide     further data on safety and tolerability of ciclesonide.   "
177445|NCT00163475|"     Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally     active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown     effectiveness in the treatment of asthma.      The aim of the study is to compare the effect of roflumilast on lung function, symptoms, and     use of rescue medication in patients with stable asthma. Roflumilast will be administered     orally either in the morning or in the evening at one dose level. The study duration consists     of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide     further data on safety, tolerability, and effectiveness of roflumilast.   "
177446|NCT00163488|"     The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide     nasal spray administered along with a fixed combination of inhaled fluticasone     dipropionate/salmeterol.   "
177447|NCT00163501|"     The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal     spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of     perennial allergic rhinitis.   "
177448|NCT00163514|"     The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal     spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of     perennial allergic rhinitis.   "
177449|NCT00163527|"     Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally     active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown     effectiveness in the treatment of asthma.      The aim of the study is to investigate the effect of roflumilast taken orally together with     low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one     dose level once daily together with inhaled corticosteroids at one dose level twice daily.     The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24     weeks). The study will provide further data on safety, tolerability, and effectiveness of     roflumilast.   "
177450|NCT00163540|"     The objective of this study is to investigate the immunogenicity and safety of a third     vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination     in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule     12 ± 2 days apart.   "
177451|NCT00163553|"     The hypothesis is that epidural pethidine is an effective form of pain relief following     lumbar spinal surgery, resulting in significantly lower usage of concomitantly administered     (intravenous) patient-controlled analgesia (PCA) pethidine.   "
177452|NCT00163566|"     The purpose of this study is to evaluate whether DHT-Gel, when applied daily to the skin, can     relieve the symptoms of low testosterone in men aged 55-80. These symptoms include reduced     muscle strength, increase fat mass, low libido, feeling blue or moody   "
177453|NCT00163579|"     The purpose of this study is whether Bryophyllum is more effective and has less side effects     than traditional labor inhibitors in preventing preterm delivery.   "
177454|NCT00163592|"     This study investigates if the time to hemostasis can be reduced by application of Tissucol®     onto femoral vascular anastomoses with PTFE prostheses compared to standard methods, such as     compression with swabs.   "
177523|NCT00164489|"     This research is meant to evaluate the effectiveness of two different prevention programs for     post-acute management of rheumatoid and osteo-arthritis   "
184308|NCT00254813|"     The purpose of this study is to evaluate the safety and tolerability of a more rapid dose     titration in acute schizophrenic patients compared to the conventional titration.   "
177455|NCT00163605|"     The purpose of this study is to evaluate the performance and to monitor the safety of the     bone substitute Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated     Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in Sinus Lift Procedures . This study     will be conducted in two parts: part A evaluates safety and performance of MBCP-FS in bone     regeneration i.e. the amount of new bone that is formed and its suitability for dental     implant placement. Part B is designed to evaluate long-term safety and performance of the     product, i.e. whether the newly-formed bone is suitable to retain implants.   "
177456|NCT00163618|"     The objective of this study is to assess the TBE antibody persistence approximately three     years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in     children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series     in Study 146A.   "
177457|NCT00163631|"     Investigate vasoactive medicators in portal hypertension on stored sera   "
177458|NCT00163644|"     The hypothesis is that exercise will improve the physical performance and quality of life of     bone marrow/ haemopoietic stem cell transplants.The aim of the trial is to provide definite     clinical evidence as to which( if any) type of exercise is most beneficial for this patient     population. It is also aimed at improving the provision of physiotherapy services to this     group of patients.   "
177459|NCT00163657|"     The purpose of this study is to compare three treatment regimens in patients who have     received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C     infection.   "
177460|NCT00163670|"     Patients who have sleep disorders may be involved in accidents more frequently than those     without. In addition patients who have sleep disorders may have more serious accidents and     have increased length of stay.We aim to recruit drivers admitted as a result of a motor     vehicle accidents and to ascertain the prevalence of sleep disorders in this group.   "
177461|NCT00163683|"     In this study we will compare the effects of a Mediterranean diet, high in fruit and     vegetables with the more conventional diet recommended for diabetes therapy (a high     carbohydrate, low fat diet) on glycaemic and lipid control and on markers of inflammation, in     people with newly diagnosed Type 2 diabetes. The hypothesis is that, over a six-month     intervention period, a HVM diet will be more effective than a conventional HCLF diet in     improving glycaemic and lipid control, and in reducing markers of vascular inflammation in     people with Type 2 diabetes.   "
177462|NCT00163696|"     The researchers are investigating a novel technique, the multi breath nitrogen washout     technique, to measure airway changes in various respiratory diseases.   "
177463|NCT00163709|"     A trial to examine whether a new heart failure blood test can improve the outcome of patients     presenting to the Emergency Department with shortness of breath.      We hypothesise that a BNP test performed in real-time in patients presenting to the Emergency     Department with shortness of breath will help identify additional patients with CHF and     consequently to change practice and allow more patients to recieve correct treatment earlier.   "
177464|NCT00163722|"     Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose     immune system is impaired it causes severe infection. The people who are particularly at     high-risk of infection with Aspergillus (which is called Invasive Aspergillosis)are those     with acute leukaemia who are having chemotherapy and those post bone marrow transplantation.     Currently 15% of those at high-risk develop Invasive Aspergillosis and 60-90% of those with     Invasive Aspergillosis die.      The main reason for this high death rate is that our current diagnostic tests are not good at     detecting infection or often only detect the infection at advanced stages when treatment is     ineffective. Because of the limitations of current diagnostic tests the current practice is     to give empiric antifungal therapy (EAFT) early to treat suspected Invasive Aspergillosis.     However studies have demonstrated that this therapy has only resulted in a minor reduction in     the mortality rates and it also causes significant drug toxicity. It is a suboptimal     treatment modality.      New tests have recently been developed to diagnose Invasive Aspergillosis. These tests are     for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA     in blood. Available data suggests that these new tests make an early diagnosis and seem to be     able to monitor responses to treatment. However no study has been reported to date which     demonstrates that the use of these tests can impact on important patient outcomes. This trial     is being performed to determine whether the use of the new diagnostic tests to guide     antifungal therapy will help improve treatment of Invasive Aspergillosis, reduce drug     toxicity and reduce the death rate in the high-risk patients as compared with the current     standard method of diagnosis and treatment with EAFT.   "
177465|NCT00163735|"     This study is designed to identify whether wines which are produced using the common     potential food allergens such as proteins derived from fish, milk or egg are likely to     contain sufficient food allergens to cause allergic reactions in susceptible individuals.   "
177466|NCT00163748|"     This is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine     combination chemotherapy with filgrastim support in an outpatient setting. Participating     patients at the time of registration will have measurable relapsed or primary refractory     lymphoma.   "
177467|NCT00163761|"     This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted     outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and     pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.   "
177468|NCT00163774|"     Analysis of cerebral blood flow (CBF) and oxygenation using complementary focal and global     monitoring techniques will permit the delivery of more informed individualised and 'targeted'     therapy on the patient with severe head injury, reduce episodes of secondary brain injury and     therefore improve outcomes.      Aims        -  To develop a deeper understanding of Cerebral Blood Flow and auto-regulation for TBI          patients based on the results of data collected in patients post TBI.        -  To establish the basis for further multi modality clinical trials in severely brain          injured patients in the future.        -  To improve understanding of the various secondary processes that continue to cause          neuronal damage after the initial injury, and therefore affect patient outcome.        -  To proceed to the second phase of the study, with the introduction of algorithms for          treatment.   "
177524|NCT00164502|"     The goal of the project is to develop and test the efficacy of a community-based     self-management intervention for reducing pain, depression, and improving self-efficacy and     function in person with limb loss   "
177469|NCT00163787|"     All participants attend for two testing sessions at either Royal Talbot Rehabilitation Centre     or the centre where they received inpatient physiotherapy services.      All participants will be tested at discharge and at six months post discharge. Personnel used     to score and administer the balance tests at six months will be blinded to pre-test scores,     subject background, as well as, mobility and fall history in the six months post discharge.      At discharge participants will perform two successful Four Square Step Tests (FSST, and will     be videotaped performing the Timed Up and Go Test (TUGT. The turn measure will be scored from     this TUGT. Participants will also complete the Locomotor Capabilities index (LCI).      At the six-month test participants repeat balance and mobility tests and LCI, as well as     being interviewed to ascertain fall history since discharge.   "
177470|NCT00163800|"     This study will attempt to evaluate clinical, laboratory and radiographic parameters together     to assess heir values in outcome prediction from brain injury. Patients will be followed up     for a period of 6 months, following admission to ICU, to assess outcome, using the Extended     Glasgow Outcome Score (GOSE).      We hypothesise that it is possible to reliably predict outcome in brain injury from the     current investigations we have at our disposal.   "
177471|NCT00163813|"     This is a multi-centre randomised controlled trial comparing early jejunal feeding (using a     frictional nasojejunal [NJ] tube) and standard feeding in critical illness.   "
177472|NCT00163826|"     The Alfred Hospital receives approximately 40% of the major trauma patients in Victoria, all     of whom are at risk for spinal injuries. The potential for spinal injuries necessitates the     undertaking of appropriate spinal investigations, and a delay in the completion of these     investigations exposes the patient to the risk of a missed diagnosis of spinal instability     and of complications of immobility; the potential spinal patient is required to wear a neck     collar and be nursed lying flat whilst awaiting the completion and the appropriate     documentation of spinal X-ray investigations.      The purpose of this study is to identify the issues causing a delay in the process of the     completion of the appropriate spinal investigations and the documentation of the results.      The outcome of the proposed research will be the development of a clinical management     protocol to expedite the process, with the aim of optimising patient care and reducing     complications.   "
177473|NCT00163839|"     This study involves investigating the effects of a pseudoallergen-free (active) diet compared     with a control (placebo) diet in the treatment of Chronic Idiopathic Urticaria (CIU) and/or     Angioedema. The hypothesis is that over a four-week intervention period, the     pseudoallergen-free diet will be more effective than the placebo diet in reducing the     frequency and severity of CIU and/or Angioedema.   "
177474|NCT00163852|"     Adult cystic fibrosis (CF) patients admitted with an acute infection complicated by acid-base     disturbance and decreased ventilation will be studied.      They will receive salt replacement to correct the acid-base disturbance and possibly their     ventilation.      Assessment of symptoms (questionnaire), acid-base and electrolyte status (blood and urine     tests) ventilation (overnight oxygen and carbon dioxide monitoring non-invasively) and     sleep-wake pattern (actigraphy) will be carried out.      Study hypothesis: Acute volume and electrolyte replacement corrects hypochloremic hypovolemic     metabolic alkalosis and compensatory hypoventilation/ hypercapnia in acute exacerbations of     cystic fibrosis.   "
177475|NCT00163865|"     The aim of the following pilot study is to examine boredom in a community sample of     adolescents and a clinical sample of adolescents. This is important in order to examine     differences among healthy adolescents and adolescents with mental illness.   "
177476|NCT00163878|"     A randomised control trial of patients who have a severe brain injury to determine if     patients who receive a standardised sensory stimulation program emerge earlier from a     vegetative state. The experimental group would receive, in addition to their normal     occuaptional therapy, sensory stimulation which would involve the daily application of     stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation     Technique (SMART).   "
177477|NCT00163891|"     Chest infection is a common complication following lung transplant (LTx). Chest physiotherapy     is widely accepted as an integral part of the management of chest infections, however there     is no evidence available regarding the effectiveness of chest physiotherapy regimes for LTx     recipients.      There is no consensus regarding whether LTx recipients should be instructed to perform     regular daily chest physiotherapy routines regardless of the presence of lung secretions (ie     prophylatically) because of the changes in mucus clearance bought about by lung transplant,     or only when they have a chest infection. Some clinicians believe that a prophylactic regimen     may be beneficial.      This research will compare two chest physiotherapy treatment regimens - our current practice     of chest physiotherapy during chest infections only (Treatment A) with an independently     performed daily chest physiotherapy regimen regardless of the presence of a chest infection     (Treatment B). From this research, we aim to develop evidence-based treatment guidelines.   "
177478|NCT00163904|"     This study is looking at overweight patients with chronic heart failure (CHF), to compare the     effects of a modified fat diet with a reduced glycaemic load (diet 1); and a conventional low     fat, high carbohydrate diet (diet 2) on:        -  insulin sensitivity (using the homeostasis model assessment [HOMA] model)        -  lipid profile        -  symptomatic status (6 minute walk distance and Heart Failure Quality of Life [HF QOL]          Questionnaire)        -  body weight        -  inflammatory mediators (tumor necrosis factor [TNF] alpha, C-reactive protein [CRP],          interleukin-6 [IL-6])      The hypotheses of this study are:        -  Diet 1 will be associated with lower insulin resistance than diet 2.        -  The lipid profile will be better in CHF patients on diet 1 than on diet 2.        -  Patients on diet 1 will have a better symptomatic status than patients on diet 2.        -  Diet 1 will maintain body weight in patients with CHF as well as diet 2.        -  Diet 1 will suppress the expression of TNF-alpha, CRP and IL-6 more than diet 2.   "
177479|NCT00163917|"     The purpose of this study is to evaluate whether a sub-population of patients with burn     injuries needing dressing changes respond to virtual reality (VR) utilising relaxation themes     with improved pain and anxiety scores, when added to PCA morphine and background analgesic     therapy.   "
177525|NCT00164515|"     This study aims to increase physical activity among overweight African-American women with     mobility limitations.   "
184354|NCT00255437|"     The study will evaluate the safety and efficacy of a new intravenously administered iron drug     to treat anemia in patients with chronic kidney disease who are not on dialysis.   "
177480|NCT00163930|"     This project seeks to evaluate the effectiveness of a new post-operative pain relief program     for women who have undergone uterine artery embolisation (UAE).      UAE is performed by an interventional radiologist as a treatment of uterine fibroids     (non-cancerous growths of the uterus.) UAE can be associated with a high level of     post-procedural pain and it is the purpose of this study to evaluate a new relief regimen for     dealing with this acute pain.      There will be two treatment groups into which patients will be randomly assigned. One will     receive the current post-operative therapy (dose-on-demand) and the other will receive the     new therapy (pre-emptive dosing). Otherwise patients will receive standard management     protocol for this procedure. Only patients that are scheduled for UAE will be enrolled (up to     40 patients).      The new treatment involves giving the patient their morphine dose orally and sixty minutes     before the procedure begins (pre-emptive dosing) as opposed to current standard treatment     which involves giving the patient a dose of morphine intravenously once they feel pain.      Information to be collected directly from patients includes pain and nausea levels, indicated     on a visual scale (a 10 centimetre line showing a spectrum of no pain to worst pain     imaginable) as well as their opinions of the effectiveness of the pain relief program and the     procedure itself. This information is to be collected immediately post-procedure and at 2, 4,     6 and 24 hours post procedure. Each VAS will take the patient approximately 20 seconds to     complete. Information about concurrent medication and procedure complications, post-operative     vomiting and respiratory depression will be collected from the patient’s history.   "
177481|NCT00163943|"     An abdominal distribution of fat is associated with the greatest heart disease risk, because     commonly, several risk factors of metabolic origin (high blood pressure, unfavourable     cholesterol profile, elevated blood sugar, impaired insulin action) cluster in these     individuals. When this occurs the condition is called the 'metabolic syndrome' (MetS). The     cause of the MetS is yet to be fully elucidated. Increased activity of the nervous system     resulting in enhanced release of the stress hormone 'norepinephrine', may be one mechanism by     which adverse cardiovascular and metabolic sequelae of the MetS might be mediated. Dietary     weight loss, and exercise are first-line treatments for the MetS and provide an opportunity     to prevent or delay the development of type 2 diabetes and heart disease in this high risk     group. However, there is a paucity of data regarding the effects of these lifestyle factors     on the nervous system. Furthermore, it is also unknown whether active weight loss ('negative     energy balance') or a stable lower weight (weight loss maintenance) is more important in     modifying MetS components and nervous system activity. The aims of the proposed project are:        1. To determine whether dietary weight loss in combination with aerobic exercise is more          beneficial than dietary weight loss alone in reducing nervous system activity and          improving metabolic and cardiovascular parameters in middle-aged men and women with          abdominal obesity and the MetS.        2. To determine whether weight loss maintenance four months after active weight loss is          associated with a preservation of clinical benefits.        3. To study biological determinants of successful weight loss and weight loss maintenance.   "
177482|NCT00163956|"     The inferior vena cava (IVC) is a large vein that enters the bottom part of the heart. Venous     blood from the lower portion of the body drains into the IVC. The IVC then returns blood back     to the heart. An IVC filter is placed to help prevent the blood clots moving from the legs to     the heart or lung. The idea behind using a filter in the IVC is to capture potential fatal     pulmonary emboli at an anatomical location where they may pose less risk for the patient.     Early filters, 1960's and 70's were, remained in the vein permanently. More recently,     temporary or retrievable filters have been developed and are being widely used.      Complications have been demonstrated with long-term placement of IVC filters. In a randomised     study it was found that that patients with IVC filter placement had greater than three times     the incidence of recurrent deep vein thrombosis (DVT) compared to their control population at     two years. Blockage of the vein, recurrent pulmonary emboli, filter penetration and filter     fragmentation have all been described.      With the advent of retrievable filters (filters that can be place temporarily and then     removed at a later date) there has been renewed popularity for placement of temporary     filters. To our knowledge, no one has yet to follow the population of intended temporary IVC     filters, who undergo failed retrieval, and consequently end up with a permanent IVC filter.      We plan to prospectively enrol 40 Alfred patients who have undergone a temporary IVC filter     placement and subsequently have had failed IVC filter retrieval.      Our aim is to evaluate the long term outcomes for patients with failed IVC retrieval.      Specifically we will determine the risk, due to failed filter retrieval, of:        -  IVC stenosis        -  IVC occlusion        -  Development of DVT and        -  analyse the clinical outcomes (symptoms), their prevalence and their distribution      Patients will receive routine care and their data will be analysed annually as collected. The     follow-up period is indefinite and will be at the discretion of the treating doctor.   "
177483|NCT00163969|"     This clinical trial will determine if postoperative patients who have postoperative pain,     which has been refractory to morphine administration, will have improved pain relief     following a bolus administration of ketamine as compared with an ongoing morphine dosing     regimen   "
177484|NCT00163982|"     This study is looking at the detection of vasoactive peptides in portal hypertension.   "
177485|NCT00163995|"     This study looks at the iontophoresis of urotensin II in chronic liver disease patients.   "
177486|NCT00164008|"     The purpose of this trial is to see whether zoledronic acid is better than pamidronate to     treat low bone density in heart and lung transplant patients.   "
177487|NCT00164021|"     Gastro-oesophageal reflux (GOR) has been found to be prevalent in children with cystic     fibrosis (CF)and may further worsen lung damage via reflex bronchospasm or pulmonary     aspiration. Chest physiotherapy may result in increased episodes of GOR as demonstrated in     children. Lung transplantation may worsen pre-existing GOR. This study will determine the     prevalence, severity and significance of symptomatic and silent GOR in adults with CF before     and after lung transplant using 24hr oesophageal pH monitoring, a valid symptom     questionnaire, quality of life questionnaires and gastric emptying studies. This study will     identify the extent of GOR in a large adult CF population and the impact on lung function and     quality of life together with the effects of medical and physiotherapy treatment on     gastro-oesophageal function.   "
177488|NCT00164034|"     Test the hypothesis that the implementation of real-time, computer-prompted algorithms in the     first half hour of trauma management will result in a measurable reduction in management     errors associated with the reception and resuscitation of major trauma patients.      Demonstrate that a reduction in management errors will translate into a reduction in     morbidity and mortality.   "
177489|NCT00164047|"     We aim to investigate the effectiveness and safety of nitrous oxide (N2O) in anaesthesia.      Hypothesis In patients undergoing anaesthesia for major surgery, avoidance of N2O will reduce     hospital length of stay when compared with otherwise identically managed surgical patients     receiving N2O as a component of their anaesthesia.   "
177490|NCT00164060|"     The purpose of this study is to examine the effect of GB virus C (GBV-C) on the natural     history of chronic hepatitis C virus (HCV) infection in subjects co-infected with HIV and     HCV. The other aspect of the study is to assess the effect of GBV-C on the severity of liver     disease due to chronic hepatitis C in subjects co-infected with HIV and HCV. This will be     done by determining the point prevalence of co-infection retrospectively then following that     cohort prospectively. In addition, further individuals will be recruited in a prospective     manner.   "
177491|NCT00164073|"     The purpose of this study is to examine gene expression profiles by DNA microarray in     patients who are responders and non-responders to interferon and ribavirin treatment for     hepatitis C virus (HCV). Genes involved in inflammation and fibrosis and mediators of the     Th-1 lymphocyte response will be looked for. It is hoped that genetic targets for future more     effective and less toxic treatments will be identified.   "
177492|NCT00164086|"     The purpose of this trial is to study the effects of a medication already widely used to     treat cardiovascular disease and diabetes, in reducing the progression of myeloma.   "
177493|NCT00164099|"     All surgical procedures carry with them the risk of infection. Even a minor infection can     extend the hospitalization after cardiac surgery. The average minimum increase in length of     stay for a single infection is three days.      One of the many means used to reduce post-operative infections is the preventative, or     prophylactic, administration of antibiotics just before and just after surgery. Because     antibiotics, and for that matter surgery itself, alter the body's natural immune and     inflammatory responses and the makeup of the bacteria in the intestine, there is a great deal     of scientific interest in using the supplementation of bacteria that naturally reside in the     intestine. It is felt that by doing so, the alterations in the immune response may be     corrected and the patient better able to fight infections. There are studies using probiotics     that have demonstrated a reduction in infection rates in patients undergoing abdominal     surgery.      Subjects will be patients at high risk for infection including those with any one or more of     the following characteristics: over 65 years old, poor heart function (ejection fraction     <40), diabetes (insulin dependant or non-insulin dependant), peripheral vascular disease,     kidney dysfunction (creatinine level >2mg/dl), obesity (body surface area > 2 m2), low serum     protein levels (albumin < 2.5 mg/dl), infection of the heart valve (endocarditis), or on any     antibiotics other than standard prophylaxis before surgery.      The safety of these products has been very well established.      Patients who consent to enter the study will receive the synbiotic mix, or a placebo, which     comes in a powder that may be mixed with a drink, or washed down into the stomach through the     NG tube if the patient is still on a ventilator. Dosing will be initiated within four hours     of patient arrival in the Cardiac Surgery Intensive Care Unit and will continue on a twice     daily basis for the duration of their admission days. Infection and diarrhea data will be     monitored.   "
177494|NCT00164112|"     Studies have previously shown that a broad drug interaction screening can be performed using     enzyme specific probes such as oral caffeine for CYP1A2, N-acetyltrasferase-2 (NAT-2), and     xanthine oxidase (XO), warfarin plus vitamin K for CYP2C9, omeprazole for CYP 2C19,     dextromethorphan for CYP2D6, and midazolam for CYP3A4/5. This combination of probes has been     validated in the Cooperstown 5+1 Cocktail (5+1).1 The use of the 5+1 cocktail provides     information on the drug metabolizing enzymes that metabolize 90% of hepatically eliminated     drugs for a fraction of the costs of the individual studies. Using a cocktail of biomarkers     reduces the overall cost of drug interaction screening. The purpose of this study is to     evaluate the effects of three Food and Drug Administration (FDA) approved oral antibiotics     (azithromycin, telithromycin, and levofloxacin) on metabolism of other medications when taken     together. This will be determined by the measuring the activity of drug metabolizing enzymes     following administration of certain drug probes (caffeine, dextromethorphan, omeprazole,     midazolam, and warfarin with vitamin K). A total of 16 subjects will complete four phases of     the study: 1) Cooperstown 5+1 alone, 2) Azithromycin plus Cooperstown 5+1, 3) Telithromycin     plus Cooperstown 5+1, and 4) Levofloxacin plus Cooperstown 5+1.   "
177495|NCT00164125|"     To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated     patients.   "
177496|NCT00164138|"     Women with chronic lung disease characterised by chronic cough report urinary incontinence.     Recently there have been reports of increased urinary incontinence in girls and women with     cystic fibrosis. While coughing is a known risk factor for stress incontinence, other risk     factors and causes are poorly understood in this population. Treatment of incontinence for     patients with chronic lung disease is also poorly addressed, adding to the burden of disease     for women with chronic lung disease, carers and the health system. This project will estimate     the prevalence of women with CF and COPD compared to healthy age matched controls and will     evaluate the effect of a specific treatment and management program for these patients. The     results will be disseminated to respiratory health professionals. We hypothesise that women     with chronic cough will have a higher incidence of urinary incontinence than healthy controls     and that a specific treatment program will result in alleviation of the problems and improved     quality of life.   "
177497|NCT00164151|"     The objective of this study is to determine the efficacy and safety of HalfLytely as compared     to Visicol as bowel preparations before colonoscopic examination.   "
177498|NCT00164164|"     The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L     NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.   "
177499|NCT00164177|"     To evaluate the efficacy of standard HalfLYTELY® as a bowel cleansing preparation for adult     patients undergoing virtual colonoscopy (VC).   "
177500|NCT00164190|"     Background:      In Canada, most patients with acute myocardial infarction (AMI) present to hospitals without     cardiac catheterization facilities. Thrombolytic therapy remains the standard-of-care in     these centres. However, thrombolytic therapy achieves normal coronary flow and myocardial     perfusion in less than 50% of patients, and is associated with reocclusion, reinfarction, and     recurrent ischemia. Primary angioplasty results in more complete reperfusion and lower rates     of reocclusion, reinfarction and recurrent ischemia, but is not available in most centres.     Although patients can be transferred for primary angioplasty, long transport times are     associated with worse outcomes. An alternative strategy, described as facilitated     angioplasty, involves administration of thrombolytic therapy at the community hospital     followed by immediate transport for angioplasty. This approach achieves the benefits of     primary angioplasty without delaying treatment. A well-conducted, prospective, randomized     trial is needed to compare this strategy of facilitated angioplasty with standard     thrombolytic therapy.      Objectives:      To evaluate the safety, feasibility, and efficacy of routine transfer of patients with AMI to     an angioplasty centre immediately after thrombolysis for coronary angiography and     percutaneous coronary intervention (PCI).      Hypothesis:      A strategy of routine transfer of patients with AMI to an angioplasty centre immediately     after thrombolysis for coronary angiography and percutaneous intervention is associated with     a significantly lower incidence of the composite of death, reinfarction, recurrent ischemia,     heart failure, and shock at 30 days compared with the conventional strategy of thrombolysis     with transfer reserved for failed reperfusion and/or development of shock.      Research Plan:      Patients with ST-elevation myocardial infarction and high-risk characteristics presenting to     community hospitals without cardiac catheterization facilities will receive thrombolysis with     tenecteplase and heparin (unfractionated or low molecular weight heparin) and will then be     randomized to one of two strategies: facilitated PCI or standard treatment (thrombolysis with     provisional rescue PCI). In the facilitated PCI group, patients will be transferred     immediately to an angioplasty centre for urgent cardiac catheterization, and PCI if     appropriate. In the standard treatment group, patients will only undergo urgent angiography     for evidence of failed reperfusion and/or development of cardiogenic shock. The primary     endpoint will be the composite of death, reinfarction, recurrent ischemia, heart failure, and     shock at 30 days.   "
177501|NCT00164203|"     Anxiety and mood disorders are among the most prevalent mental health problems in childhood.     They have severe long-term morbidity, and associated academic and social impairment.      Building on the investigators' experience with outcome evaluation in clinically anxious or     depressed children, they propose to evaluate within the school system a cognitive behavioral     therapy (CBT) intervention for children in grades 3 to 6 with elevated symptoms of anxiety or     depression on standardized questionnaires.      The participant's outcomes will be compared with those of similar children randomly assigned     to an activity control group.      Hypothesis 1a): Children in the intervention condition will show greater symptom reduction     relative to children in the control condition (primary outcome: anxiety symptoms).      Hypothesis 1b): Children in the intervention condition will show fewer symptoms during     follow-up relative to children in the control condition.      Hypothesis 2: Children with anxious or depressive symptoms treated in the school setting     using CBT have a lower risk of developing internalizing disorders within 1 year of treatment     than children in a control condition.      Hypothesis 3: Self-esteem, anxiety and depression-related impairment, and academic     functioning will improve more in intervention participants than in controls.      Hypothesis 4: School characteristics, child age, and attitudes of participating personnel are     predictive of treatment response.   "
177502|NCT00164216|"     This is a study of the efficacy and effectiveness of combination therapy for malaria due to     P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects     ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients     will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and     artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one     will receive drugs under direct supervision and the other will be instructed on how to take     the drugs by themselves. Clinical and parasitologic response will be monitored for a     follow-up period of 28 days. The findings of this study will be used to guide the Ministry of     Health in evaluating its national policy for P. falciparum malaria treatment.   "
177503|NCT00164229|"     Comprehensive evaluation (geneticist, psychologist, social worker, education specialist,     others as indicated) to determine individual needs and treatment plan. Referrals for specific     services (e.g., OT, counseling, medications, etc) will be to clinicians within the families'     own communities. All families will receive evaluation, parent education/advocacy, and     learning readiness program. Only the intervention group will receive the math intervention.   "
177504|NCT00164242|"     Tardive dyskinesia (TD), a form of movement disorder, remains a problem for some patients who     received antipsychotic medications. Increasing evidence suggests that TD may result from     antipsychotic-induced dysfunction in striatal cholinergic neurons. To test whether     cholinesterase inhibitors compensate for diminished cholinergic activity underlying TD, we     conducted a 30-week randomized, double-blind, placebo-controlled crossover study of     galantamine in 36 patients with TD.   "
177505|NCT00164255|"     This study is an investigation to compare the efficacy of two different intermittent     sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine     (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing     placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally     efficacious and safe as intermittent protective SP, such a regimen could be adapted for     programmatic use as a potentially more durable alternative to SP monotherapy in areas of     increasing SP resistance.   "
177506|NCT00164268|"     The purpose of the project is to examine the efficacy of a culturally-based intervention,     compared to standard agency services, in enhancing self-care among Native Hawaiian women and     decreasing IPV/SV perpetration and related factors among Native Hawaiian men.   "
177507|NCT00164281|"     This is a randomized, blinded, two-arm comparative trial of continued versus limited     isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and     Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of     36 months.   "
177508|NCT00164294|"     Disability and death from injury remain a persistent problem in the U.S. and risk-taking     behaviors are known to contribute to injury. Healthy People 2010 set goals to reduce deaths     caused by injury: Motor vehicle crashes are often predictable and preventable. Increased use     of seat belts and reductions in driving while impaired are two of the most effective means to     reduce the risk of death and serious injury of occupants in motor vehicle crashes. One     preventive strategy is to establish screening and intervention procedures that can be     administered in the ED to young adults who have risky driving practices and problem drinking.     Goal: The specific aim of this prospective, randomized controlled trial is to test the     effectiveness of a brief intervention to limit risky driving behaviors (risky driving     practices, lack of seat belt compliance) and problem drinking in drivers during an ED visit.     In addition, the trial will result in a benefit-cost analysis from the perspectives of both     society as a whole and hospitals in particular. Methods: Young adults 18 to 44 years will be     screened for problem drinking and risky driving practices during an ED visit. Subjects who     screen positive for problem drinking and risky driving will be randomized to one of three     groups: No Contact Control Group (NCG: after informed consent, subjects receive no screening     or intervention until 12 months after injury). Contact Control Group (CCG: subjects screened     at baseline and every three months for 12 months but no intervention), and a Brief     Intervention Group (BIG: subjects receive screening and brief intervention with data     collection points every three months for 12 months). A total of 133 subjects per group     (N=400) will be enrolled. The intervention will consist of a 20 minute nurse visit in the ED     and a booster intervention at 7-10 days after ED discharge. All subjects will be telephoned     at 3, 6, 9, and 12 months by interviewers blinded to condition. Outcomes of interest include     reported alcohol use, risky driving behaviors, driving citations, adverse health outcomes,     and costs (health care utilization, property damage, travel delays, lost work productivity,     criminal justice expenses, and monetarized adverse health outcomes). Analysis: Power analysis     suggests that 133 subjects in each arm of the trial will have sufficient power to detect a     difference of the main outcome variables of interest. A variety of regression techniques,     including individual growth curve modeling and event history analysis, will be used to test     the proposed hypotheses.   "
177509|NCT00164307|"     Children will be randomly assigned to a Parent-assisted social skills training or Wait list.     Baseline and post intervention rating will be obtained from teachers.   "
177510|NCT00164320|"     The purpose of this study is to determine if the TEAM prevention intervention delivered by a     physician and an HIV-positive counselor is effective. It is hypothesized that those who     receive the intervention will report a higher reduction in risky sex than those who were in     the standard-care condition.   "
177511|NCT00164333|"     The purpose of the study is to test the efficacy of TAP, a behavioral intervention, in     improving sexual safety and treatment adherence among gay and bisexual men infected with HIV.     It is hypothesized that those who are in the intervention group will report reductions in     unprotected sex with HIV-negative and unknown-status partners; and will show stricter     adherence to their treatment regimens, compared to the individuals in the standard-of-care,     control group.   "
184355|NCT00255450|"     This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared     to placebo in patients with chronic kidney disease.   "
177512|NCT00164346|"     Children will receive comprehensive evaluations through the Children's Research Triangle     (CRT) clinical program. The assessment for the child will be in accordance with the protocol     developed by Astley and Clarren as performed by one of the clinic pediatricians and final     diagnosis will be according to Institute of Medicine (IOM) criteria. Children will be     randomized into either a Treatment or Control group. The Treatment group will receive (in     addition to standard referrals) neurocognitive habilitation and psychotherapy services as     well as parent psychoeducation. The Control group will be referred for intervention through     existing community and school-based agencies.   "
177513|NCT00164359|"     Sulfadoxine-pyrimethamine is the current first-line therapy for uncomplicated malaria in     Malawi. Significant resistance of the P. falciparum malaria parasite to this drug has led to     an imminent need for the government of Malawi to identify a new first-line therapy for     uncomplicated malaria and to implement that new therapy as policy. This protocol is the     second of two protocols whose combined purpose is to provide efficacy and side effect data on     four antimalarial drug combinations that are candidates for the next first-line therapy for     uncomplicated malaria in Malawi. This protocol aims to assess the acceptability and     tolerability of amodiaquine in Malawi. It is a double-blind study comparing amodiaquine plus     artesunate (AQ-Art, one of the candidate combination therapies) to chlorproguanil/dapsone     plus artesunate (CD-Art, another of the candidate combination therapies) in persons 5 years     and older, to see if there is a higher incidence of abdominal pain and/or refusal to take the     therapy in the AQ-Art group. Amodiaquine was removed from the Malawian national drug registry     in 1995 because of a perceived association with abdominal pain. Although no studies were     conducted to substantiate this, consensus among clinicians was that patients were refusing     amodiaquine with increasing frequency, citing abdominal pain as the reason, so the drug was     removed from the registry. Results from this study, along with the efficacy data from the     sister protocol in children under five years of age, will help guide the National Malaria     Control Program of Malawi in selecting their next first-line antimalarial therapy.   "
177514|NCT00164372|"     The purpose of this study is to test whether a six-session behavioral intervention for HIV     and HCV seronegative injection drug users is effective in reducing sexual and injection risk     behaviors that could lead to primary HIV and HCV infection.   "
177515|NCT00164385|"     The primary objective of Adolescent Impact is to develop and evaluate a developmentally     targeted intervention designed to minimize secondary transmission risk behavior and enhance     adherence to care and treatment. The intervention is delivered in 12 sessions (five     one-to-one, 7 group) over a 3 month period of time. Intervention is delivered in addition to     standard of care treatment at the participant's respective clinic. Participants are     randomized to either an intervention or control arm; the control group receives standard of     care treatment and control group participants are offered the Adolescent Impact intervention     following the completion of the nine-month follow up. It is hypothesized that compared to     control group participants, intervention group participants will evidence (1) improved or     stable virologic and/or immunologic status, mediated by (a) adherence to prescribed     antiretroviral medication and/or (b) adherence to HIV care appointments, and (2)     reduction/minimization of secondary transmission risk behaviors to include (a) unprotected     sex and/or needle sharing, and (b) sexual and drug use behaviors that increase risk for     unprotected sex.   "
177516|NCT00164398|"     The purpose is to encourage Provider participants to evaluate high risk HIV transmission     behaviors and offer prevention messages to their HIV+ patients which will, in turn, reduce     rates of unprotected anal and/or vaginal sex with partners of known HIV sero-negativity or     unknown HIV serostatus. It is hypothesized that patients of providers participating in the     HIP intervention will report higher reduction in sexual risk practices, when compared to the     patients of the providers who were randomized into the control condition.   "
177517|NCT00164411|"     The purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination     (tetanus shot) before giving pneumococcal vaccine makes the pneumococcal vaccine more     effective without causing too many side effects.   "
177518|NCT00164424|"     The purpose of this study is to determine if acyclovir episodic treatment has an effect in     ulcer healing and if it should be added to the syndromic management of genital ulcer disease.   "
177519|NCT00164437|"     The study populations consist of a sample of the patient population (men aged 40-79 years) of     a large, group model HMO and a community sample of men age 50-79. Follow-up interviews of men     randomly assigned to the intervention and control groups are being conducted by telephone to     assess issues related to prostate cancer screening and the men’s use of the CD-Rom     educational intervention.   "
177520|NCT00164450|"     Compared to adults, children appear to require higher weight-based doses of rifapentine to     acheive comparable drug levels. TBTC Study 26, a study of the effectiveness and tolerability     of weekly rifapentine/isoniazid for three months versus daily isoniazid for nine months for     the treatment of latent tuberculosis infection, has been amended to include children ages     2-11 based on an initial single-dose study and pharmacokinetic modeling. Study 26PK evaluates     the adequacy of the doses chosen for young children enrolled in Study 26 with a single blood     draw, 24 hours after the third or subsequent weekly Study 26 dose of rifapentine and     isoniazid. An adult control is enrolled for each child enrolled.   "
177521|NCT00164463|"     This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin     alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the     pharmacokinetics of moxifloxacin among patients with tuberculosis being treated with     multidrug therapy (isoniazid or ethambutol, rifampin, and pyrazinamide) to those of healthy     volunteers receiving moxifloxacin plus rifampin. It also evaluates the association between     polymorphisms of MDR1 genotype (P-glycoprotein) and rifampin pharmacokinetic parameters, the     effect of polymorphisms of MDR1 genotype and/or rifampin pharmacokinetics on isoniazid     pharmacokinetic parameters adjusted for N-acetyltransferase genotype (NAT2), and determines     by multivariate regression analyses the associations between moxifloxacin or rifampin     pharmacokinetic parameters and markers of tuberculosis disease severity including the     covariates of two-month culture positivity, cavitary lung disease, Body Mass Index, weight,     duration of study treatment prior to PK, co-morbidities and C-reactive protein. Healthy     volunteers and TB patients receive frequent scheduled blood draws during a 24 hour period     after ingesting a dose of TB drugs.   "
177526|NCT00164528|"     Children diagnosed through the FAS DPN clinic (who receive non-study services through the     clinic/referrals) will receive baseline assessment. The baseline assessment for the child     will include: medical issues (including medication), intellectual assessment, academic     achievement, language, social functioning, executive functioning, neurological assessment,     perceived self-confidence, and behavioral observation of parent-child interactions     (videotaped and coded). For caregivers, baseline assessment will include: demographics,     medical histories, educational history, current services, satisfaction with services,     knowledge of FAS, stress, parenting competence, and family functioning.   "
177527|NCT00164541|"     this project will evaluate a community and school based program to promote healthy     relationships and prevent violence (physical, emotional and sexual dating violence) among     predominately African American middle school adolescents in an urban setting (Baltimore, MD).   "
177528|NCT00164554|"     Children will receive comprehensive evaluations through the UOHSC ABC program The assessment     for the child will include: medical issues (including medication), dysmorphic examination,     intellectual assessment, academic achievement, language, and motor skills. This program will     provide appropriate non-study services and referrals. Eligible families will be randomly     assigned to treatment group or control group. Treatment group will receive Parent Child     Interaction Therapy (PCIT). The Control group will receive standard referrals and services     through the ABC program and the parent education/advocacy component of the project.   "
177529|NCT00164567|"     The purpose of this study is to implement universal screening for intimate partner violence     (IPV) and to test two clinic-based interventions for women who screen positive for current or     recent IPV. The study population will be implemented in Pee Dee region of the state of South     Carolina and will include primarily low-income women who seek care at selected primary health     care clinics in the region.      In this study, all women 18 and older receiving care at selected primary care clinics will be     offered screening for IPV annually. Clinicians will use a structured screening tool to assess     physical, sexual, and psychological IPV in a current relationship (IPV+) or IPV experienced     by the woman in the past five years (Recent IPV). Clinics will be randomly assigned to     implement a clinic-based intervention for women who screen positive for current or recent     IPV. Two interventions will be implemented using a factorial design. In the     Empowerment-Focused Patient Education Intervention, clinicians will conduct a 7-session     intervention focusing on the health and well-being of the woman and attempt to link women's     IPV experience with their health. In the IPV Services Intervention, IPV Specialists who are     trained advocates from the Pee Dee Coalition Against Domestic and Sexual Assault (PDC) will     be based in the clinic to (a) counsel women about IPV including safety planning, (b) provide     linkages to PDC services, and (c) link women to clinic-based support groups developed     specifically for this project.      We hypothesize the intervention(s) will change (a) clinician screening, referral, and IPV     documentation patterns, (b) clinician IPV knowledge and perceived skills in working with     women who have experienced IPV and their children (c) women's help-seeking behaviors, risk of     poor mental and physical health, and (d) women's risk of subsequent IPV victimization. To     evaluate these outcomes, we will survey clinicians and prospectively follow a group of     consenting IPV+ women (N=300 in each intervention arm) to assess changes in their     help-seeking, health behavior and status, IPV experience over two-years of follow-up.   "
177530|NCT00164580|"     The purpose of this study is to test whether a multi-component, community-level,     HIV-prevention intervention is more effective than existing HIV prevention activities in     reducing unprotected anal intercourse (UAI) among men ages 15-25 who have sex with men.   "
177531|NCT00164593|"     This project is an evaluation of an intervention to involve youth in creating community     change for peace promotion and violence prevention. The intervention, Youth Empowerment     Solutions for Peaceful Communities (YES), includes three components: youth empowerment     activities, neighborhood organization development, and community development projects that     involve youth and organizations working together.      Hypothesis 1: Efforts to engage youth in the community change process will enhance their     attachment to their community, reduce their problem behaviors, and begin to change norms     among their peers about community violence and interpersonal problem solving.      Hypothesis 2: Efforts to make community-based organizations more youth-friendly and engaging     will assist them to be more effective in reaching their community enhancement goals and will     expand youth involvement in their mission.      Hypothesis 3: Efforts to create more health-enhancing land use (e.g., beautification,     community gardens, parks development) will improve social organization (e.g., social capital,     social cohesion, and social support), and reduce the level of violent incidents and crime in     the community.   "
177532|NCT00164606|"     This is a population-based evaluation of the effectiveness of the Triple-P-Positive Parenting     Program. Triple-P is a system of parenting programs with multiple levels that aims to provide     parents with parenting skills and support.   "
177533|NCT00164619|"     The purpose of the project is to determine whether the VOICES/VOCES intervention, that was     shown to be effective in a research study, is still effective when delivered by STD/HIV     prevention agencies.      VOICES/VOCES is a brief, single-session intervention for African-American and Latino adult     men and women at high risk for STD/HIV. It encourages condom use and improves condom     negotiation skills. A health educator delivers the intervention to groups of 4 to 8 clinic     patients in a private room. Groups are made up of people of the same sex and same race or     ethnicity. Information on STD/HIV risk behaviors and condom use is delivered by     culturally-specific videos, group discussion, and a poster presenting features of various     condom brands. Participants role-play condom negotiation modeled in the videos. At the end of     the session they are given sample condoms of their choice.      In this project, health educators from the health departments of New York City and San Juan,     Puerto Rico conducted the VOICES/VOCES intervention with a sample of patients from one STD     clinic in each of their cities. Researchers helped the health departments test whether the     intervention is effective when local health educators deliver it.   "
177534|NCT00164632|"     A randomized controlled multi-component fall prevention study for older adults. The study     integrates fall prevention into an existing community-based public health program for older     adults.   "
177547|NCT00164801|"     The effect of baclofen (GABAB agonist), diltiazem (muscle relaxant) and placebo will be     compared in a double-blinded randomized study for the treatment of NCCP. Cerebral cortical,     brainstem and spinal evoked potentials before and after treatment will be evaluated. Results     of this study will shed lights on pathogenesis and treatment of NCCP in Chinese.We     hypothesize that Baclofen alleviates visceral hyperalgesia in NCCP patients by suppressing     afferent sensory pathway.   "
177589|NCT00165399|"     The purpose of this study is to see if the combination of chemotherapy drugs and drugs to     suppress testosterone (hormone therapy) is effective in controlling early prostate cancer.      This study will attempt to:        -  stop or slow the growth of disease        -  gain information about prostate cancer        -  evaluate the effectiveness and side effects of the study drug   "
184356|NCT00255463|"     The purpose of this study is to compare the changes in a proliferation biomarker in subjects     receiving Anastrozole or Anastrozole/ZD1839 combination.   "
177535|NCT00164645|"     Family caregivers of persons with traumatic brain injury (TBI) have long-term demands that     tax their coping abilities and adversely affect their health and well-being. This project     will test the effectiveness of a problem-solving training program tailored to the unique     needs of family caregivers of persons with TBI. Over a 3-year period, family caregivers and     their care recipients will be recruited and randomly assigned to a problem-solving     intervention group (n=40 dyads) or a control group (n=40 dyads). Participants in the     problem-solving intervention group will receive four face-to-face problem-solving training     sessions and monthly telephone problem-solving sessions over the course of 1 year. Control     group participants will receive a handbook of educational materials and a staff member will     contact each control group participant monthly by telephone to review these materials and     other informational needs. No problem-solving training will be provided to control     participants throughout the year.      Caregivers and care recipients will be assessed at four points during their participation: at     the initial assessment, at 4 months, at 8 months, and at the completion of the 1-year     participation period. All evaluations will be conducted in the participants' homes. Measures     of problem-solving ability, caregiver burden, and adjustment (depression, health,     satisfaction with life) will be collected. Structural equation modeling and other     regression/inferential analyses will be used to determine the effects of problem solving on     caregiver adjustment over time after taking into account care recipient adjustment and     caregiver ethnicity. This project will: (1) demonstrate how specified physical and emotional     outcomes of caregivers and care recipients are related to caregiver problem-solving abilities     and how these relationships vary as a function of time; (2) evaluate the effectiveness of a     community-based, problem-solving intervention that will be delivered to caregivers; and (3)     identify caregivers and care recipients with TBI who are at risk for adverse emotional and     health outcomes.   "
177536|NCT00164658|"     The study will evaluate the effect of familial risk assessment and prevention prompts     tailored to familial risk on health behaviors and use of preventive services among adults who     are members of primary care practices in the U.S.   "
177537|NCT00164671|"     The intent of this project is to replicate the POWER pilot campaign using a randomized     controlled trial with neighborhoods as the unit of randomization and analysis. We plan to     rigorously test the effects of the POWER campaign on women’s knowledge of, attitudes toward     and use of female and male condoms for the prevention of sexually transmitted disease (STD)     and unintended pregnancy. We will work in 12 non-contiguous neighborhoods in four     southwestern U.S. cities (four each in Oakland/Alameda County and Los Angeles and two each in     San Diego and Las Vegas). We will complete a baseline assessment in all 12 neighborhoods to     document knowledge of, attitudes toward and use of female and male condoms. We will then     randomly assign six neighborhoods to intervention status and six neighborhoods to control     status. We will adapt the campaign for each city, and implement it in six intervention     neighborhoods for nine months, and will complete a follow-up assessment similar to the     baseline assessment, with added questions regarding exposure to the POWER campaign. Study     partners include Dr. Sheana Bull and research staff from the Colorado Health Outcomes Program     (COHO) of the University of Colorado Health Sciences Center, Educational Message Services     (EMS), and Centers for Disease Control and Prevention (CDC).   "
177538|NCT00164684|"     A 16 session curriculum, developed for noncustodial African American and Latino fathers to     improve knowledge, attitudes and skills and enable participants to remain non-violent towards     their partners will be evaluated.   "
177539|NCT00164697|"     The purpose of this study is to determine if an intervention focused on promoting     parent-child interaction, parental responsibility, parental commitment of time and energy,     and sense of community results in better developmental outcomes for low-income children.   "
177540|NCT00164710|"     Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria     in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that     the drug is much less effective than in previous years. This study was developed and     conducted in collaboration with the National Malaria Control Programme of Malawi to assess     the efficacy of four antimalarial drug combinations to provide evidence to assist the     Malawian Ministry of Health in identifying and implementing as policy the next first-line     antimalarial for uncomplicated malaria in Malawi. In an open, randomized trial in children     under five years of age, four drug combinations, all of which are licensed in Malawi, are     being assessed: amodiaquine plus sulfadoxine-pyrimethamine (AQ-SP), amodiaquine plus     artesunate (AQ-Art), chlorproguanil-dapsone plus artesunate (CD-Art) and     lumefantrine-artemether (LA). SP is also included as a fifth arm of the study for current     data on its efficacy. Data on side effects of the drugs will also be collected. The results     of this study will provide some of the information necessary to guide the Malawi National     Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated     malaria. The study adheres to the World Health Organization's 2003 standardized protocol for     assessing antimalarial drug efficacy.   "
177541|NCT00164723|"     To evaluate the incidence and etiology of small bowel or large bowel bleeding in patients     presenting with melena.   "
177542|NCT00164736|"     This is a comparative clinical trial among HIV-infected women and their infants to determine:        1. the benefit of nutritional supplementation given to women during breastfeeding        2. the benefit and safety of antiretroviral (ARV) medications given either to infants or to          their mothers to prevent HIV transmission during breastfeeding        3. the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding          cessation   "
177543|NCT00164749|"     The purpose of this study is to develop procedures for testing the effectiveness of curcumin     on slowing Alzheimer's disease (AD) progression.   "
177544|NCT00164762|"     The purpose of this study is to determine whether the addition of zidovudine (ZDV) and     lamivudine (3TC) at the onset of labor and for up to seven days postpartum to single-dose     nevirapine (NVP) is associated with a lower prevalence of NVP-resistant HIV compared to     single-dose NVP without ZDV+3TC.   "
177545|NCT00164775|"     The aim of this study is evaluate the efficacy of Imipramine, a tricyclic antidepressant, in     treatment of functional dyspepsia. This is a double blind randomised placebo controlled trial     in which consecutive patients with diagnosis of functional dyspepsia will be studied. After     exclusion of organic cause of dyspepsia by endoscopy, these patients will be randomly     assigned to either imipramine or placebo. All the patients will enter an additional 4 weeks     of drug withdrawal phase after the initial 12 weeks of study drug treatment. They will be     evaluated for treatment response, which is defined as satisfactory relief of dyspeptic     symptoms at the end of 12-week treatment.   "
177546|NCT00164788|"     The investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by     8mg/h would render gastric pH near neutral and that pH control with esomeprazole given in     such a high dose either intravenous or orally is identical.   "
177584|NCT00165334|"     The purpose of this study is it to determine how well patients with non-small cell lung     cancer respond to cetuximab plus vinorelbine. We would also like to determine the safety of     cetuximab plus vinorelbine in people 70 years of age or older with advanced non-small cell     lung cancer.   "
177548|NCT00164814|"     Noncardiac chest pain (NCCP) is a common clinical problem worldwide. In Hong Kong, it has     been estimated that about 20% of patients with chest pain are misdiagnosed to have coronary     heart disease. Despite its benign nature, this condition causes anxiety, impairs quality of     life and consumes a substantial amount of healthcare resources. While acid reflux and     motility disorder in the esophagus are often attributed as the cause of NCCP, visceral     hyperalgesia of esophagus is now recognized to play a central role in the pathogenesis of     this condition. This research project aims to evaluate the role of visceral hyperalgesia in     Chinese patients with NCCP. NCCP patients will be evaluated for the prevalence of     gastroesophageal reflux disease and esophageal motility disorder by endoscopy, manometry and     pH study. The visceral sensory and pain thresholds of these patients will be compared with     asymptomatic controls.   "
177549|NCT00164827|"     To investigate the adjunctive role of “Capsule Endoscope” in continuous endoscopic monitoring     and early detection of recurrent ulcer bleeding after endoscopic therapy in patients     presenting with bleeding peptic ulcers   "
177550|NCT00164840|"     Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended     modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet     in clinical practice treatment is commonly given in short courses on as required basis during     symptom flare up, particularly for patients with mild to moderate GERD.      On-demand therapy also has the potential advantage that patient does not need to take regular     medications, thereby improving the quality of life. However, whether on-demand PPI therapy     achieves similar efficacy of symptom control is uncertain.      The aim of this study is to compare the efficacy and quality of life of on-demand and     maintenance PPI regimens in long-term management of non-erosive GERD patients. The     investigators hypothesize that on-demand PPI treatment is as effective as maintenance PPI.   "
177551|NCT00164853|"     To compare the technique of combined balloon sphincter dilation after an initial     sphincterotomy and standard sphincterotomy in the endoscopic removal of large bile duct     stones. The investigators hypothesize that combined balloon dilation and sphincterotomy     allows for easier stone removal without added morbidities when compared to standard     sphincterotomy.   "
177552|NCT00164866|"     To evaluate if intravenous PPI infusion, when administered prior to endoscopy, hastens     resolution of bleeding stigmata and thereby facilitates endoscopic examinations and reduces     the need for endoscopic treatment. Clot stabilization may itself sustain control of bleeding     before endoscopy. These may translate into improved patients’outcome and survival.      To determine the therapeutic effect of high-dose PPI infusion in upper gastrointestinal     bleeding from causes other than peptic ulcers.   "
177553|NCT00164879|"     The aim of this study is to compare the stoma rate, clinical efficacy, and safety of patients     treated by endoscopic stenting followed by elective laparoscopic resection (the     'endolaparoscopic approach') versus immediate emergency surgery for obstructing left-sided     colorectal cancers.   "
177554|NCT00164892|"     The purpose of this study is to investigate the efficacy of selective COX-II inhibitor in     patients with curative resection performed for locally advanced stomach cancer.   "
177555|NCT00164905|"     The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients     who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail     endoscopic therapy.   "
177556|NCT00164918|"     The aim of the study is to evaluate whether subtotal gastrectomy without post-operative     nasogastric decompression is better in terms of early post-operative bowel function and chest     complication.   "
177557|NCT00164931|"     A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion     against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic     endoscopy.   "
177558|NCT00164944|"     To determine the prevalence of colorectal neoplasms in first degree relatives of those     affected with sporadic colorectal cancer using colonoscopy as a screening tool. The     prevalence will be compared to that of a defined matched cohort.   "
177559|NCT00164957|"     Background:      Tube feeding had been found to be a cause of aspiration pneumonia. Continuous pump feeding at     slower rates as compared to bolus feeding may be less associated with aspiration pneumonia.      Methods:      Randomized controlled trial      Subjects:      Patients expected to remain on tube feeding for 4 or more weeks      Outcomes:      1) pneumonia, 2) mortality   "
177560|NCT00164970|"     Background: Vitamin B12 and folate are essential to brain health. Sub optimal status of     vitamin B12 and folate leads to elevation of plasma homocysteine concentration, which is     associated with Dementia. Vitamin B12 and folate supplementation improved the cognitive     function of demented subjects with hyperhomocysteinaemia in a pilot study.      Objective: To determine the effectiveness of vitamin B12 and folate supplementation in     preserving cognitive function of subjects with early dementia   "
177561|NCT00164996|"     The purpose of this study is to investigate whether an ultrathin endoscope will improve a     patient's tolerance during the procedure. In addition, this study will look at whether local     pharyngeal anaesthesia is necessary during ultrathin endoscopy.   "
177562|NCT00165009|"     To compare the efficacy of a novel endoscopic clipping device(Resolution Clip™) and     conventional epinephrine injection and heater probe thermocoagulation in control of peptic     ulcer bleeding and prevention of recurrent bleeding   "
177585|NCT00165347|"     The purpose of this study is to determine whether or not cancer cells in the body are     affected by PTK and whether it affects the growth of these cells.   "
177586|NCT00165360|"     The purpose of this trial is to determine the effects (good and bad) temozolomide has on     patients with low-grade glioma. It will also determine whether temozolomide is effective in     preventing or delaying future tumor growth.   "
177587|NCT00165373|"     The purpose of this study is to assess the safety of rhEndostatin, to determine how much of     the drug stays in the patients blood (pharmacokinetics), to assess the development of     proteins in the blood that are produced by the body (antibodies)using rhEndostatin, to     determine the effect of rhEndostatin on the formation of new blood vessel factors, and to     perform an analysis of the effect of rhEndostatin on circulating endothelial precursor cells     (cells in the body that help the tumor build more blood vessels).   "
177588|NCT00165386|"     The purpose of this study is to target lesions of the prostate in the bone and to biopsy     these lesions using MRI to identify the areas.   "
177563|NCT00165022|"     A questionnaire composed of items addressing psychological, emotional and social aspects of     GERD is developed for Chinese population. We plan to conduct a validation study on this novel     disease-specific quality of life (QoL) instrument. This study aims to evaluate various     indicators of validity and reliability, which include criterion validity, test-retest     reliability, responsiveness, internal consistency reliability and discriminant validity.      After initial pilot testing of face validity and content validity, two hundred GERD patients     from the gastroenterology and ulcer clinics of cluster NTE hospitals will be invited to     complete a revised 18-item version of GERD-QOL questionnaire. The data from GERD QOL will be     evaluated using exploratory factor analysis to identify appropriate items and domains and the     internal consistency of the domains will be determined and further refinement of     questionnaire will follow.      100 GERD patients will complete GERD-QOL, SF-36 health survey and the visual analog scale     (VAS) questionnaire for criterion validation. 100 GERD patients with stable symptom profile     will repeat GERD QOL two weeks after the first administration for evaluation of test-retest     reliability.      Another 26 patients who are receiving maintenance acid suppressive therapy and in remission     of symptom will be recruited as controls for comparison with active reflux patients. The     ability to distinguish active patients from controls in remission is known as discriminant     validity.   "
177564|NCT00165035|"     The purpose of this study is to evaluate the safety and effectiveness of the investigational     stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison     to a surface coated DES stent (TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent) in the     treatment of single-vessel (one blood vessel) and multi-vessel (two or three blood vessels)     coronary artery disease.   "
177565|NCT00165048|"     The purpose of this study is to investigate the effect of selective COX-II inhibitor in     patients with regionally disseminated stomach cancer treated by palliative resection (so     called R1 or R2 gastrectomy).   "
177566|NCT00165061|"     A multicenter randomized comparison of primary esophagectomy against definitive     chemoradiotherapy for the treatment of squamous esophageal cancer.   "
177567|NCT00165074|"     The purpose of the study is to determine whether additional surfactant(Infasurf) doses at 7     to 10 days of life time will improve lung function in premature infants, allowing a decrease     in required oxygen concentration and ventilator settings.   "
177568|NCT00165087|"     The purpose of this study is to reduce the side-effects and discomfort of anti-leukemia     therapy, to attain long-term control of the disease and to hopefully eradicate it.   "
177569|NCT00165100|"     The purpose of this study is to evaluate whether this new method of taking pictures called     Dynamic Area Telethermometry (DAT) might be a good way of looking at patients with cancer     that is relatively close to the surface of the body.   "
177570|NCT00165126|"     The purpose of this study is to investigate the effect of certain variables such as the     fullness of the patients bladder and the position of the treatment applicator on the dose of     radiation that other organs such as the bladder and the rectum receive during radiation     treatment for endometrial carcinoma.   "
177571|NCT00165139|"     The main purpose of this study is to determine the short and long term side effects of a very     intensive treatment, which includes combinations of chemotherapy drugs followed by radiation     therapy and two transplants supported by peripheral blood progenitor cells (stem cells), for     children with advanced stage neuroblastoma and sarcomas.   "
177572|NCT00165152|"     To evaluate two different ways of providing information about genetic testing for BRCA1 and     BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed     consent which cover similar material but are organized differently.   "
177573|NCT00165178|"     The purpose of this study is to reduce the side-effects from anti-leukemia therapy. The     therapy in this study is based upon treatment information learned from prior clinical     research programs as well as from laboratory research.   "
177574|NCT00165191|"     The purpose of this study is to collect information on the anti-tumor activity of the     combination doxorubicin, cisplatin, and 5-fluorouracil when given to patients with advanced     esophageal or gastric adenocarcinoma. We will also be collecting information about the side     effects and safety of this combination.   "
177575|NCT00165204|"     Women undergoing surgical menopause often experience marked menopausal side effects but are     reluctant to use estrogen or other female hormones to ease the transition to menopause     because of worries that the hormones may increase breast cancer risks. This study will     evaluate tibolone in women experiencing surgical menopause to assess its effects on bone     health, menopause symptoms and breast density.   "
177576|NCT00165217|"     The purpose of this study is to collect information about the antitumor activity and the     safety of capecitabine and thalidomide in patients with colorectal cancer.   "
177577|NCT00165230|"     The purpose of this study is to find out what effects, good or bad, that thalidomide and     temodar have on patients with neuroendocrine tumors.   "
177578|NCT00165243|"     The purpose of this study is to evaluate whether treatment to the axilla (area under the arm)     can be safely minimized by omitting axillary surgery and full axillary radiation therapy and     replacing it with radiation therapy to the breast and lower axilla.   "
177579|NCT00165256|"     The purpose of this study is to determine if wide excision (surgical removal) alone is     adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast.   "
177580|NCT00165269|"     The purpose of this study it to evaluate the effectiveness of radiation therapy limited to     above the diaphragm in patients with pathological stage IA-IIA Hodgkin's disease.   "
177581|NCT00165282|"     The main purpose of this study is to examine techniques to help patients cope better with the     stem cell/bone marrow transplant procedure.   "
177582|NCT00165295|"     The purpose of this study is to determine the effects (good or bad) that sildenafil (Viagra)     has on patients with slow growing Waldenstrom's macroglobulinemia (WM). Sildenafil blocks the     function of several proteins necessary to the survival of certain types of cancer and     laboratory tests have shown that it can destroy WM cells.   "
177583|NCT00165308|"     The purpose of this study is determine whether or not tamoxifen reduces the chance of     Hodgkin's Disease survivors developing breast cancer.   "
184357|NCT00255476|"     The purpose of this study is to compare the objectie tumour response rate between the     cisplatin/5FU and cisplatin/5FU plus ZD1839 combination   "
177591|NCT00165425|"     The main purpose of this study is to determine if it is possible to put into practice a     cardiac screening program for survivors of Hodgkin's disease. In this study, we would also     like to screen for cardiac risk factors that can be modified either through life-style     changes or medications, to uncover significant abnormal heart findings in which treatments     may be needed, and to see if there is a link between cardiac health and quality of life.   "
177592|NCT00165438|"     The purpose of this study is to find out the impact Bleomycin-containing chemotherapy, given     with or without chest radiation therapy, on patients' lung function over time.   "
177593|NCT00165451|"     This study will use a combination of four oral drugs (thalidomide, cyclophosphamide,     etoposide and celecoxib) to treat patients with relapsed or progressive cancer. These drugs     are expected to target the blood vessels that supply the tumors with what they need to grow.   "
177594|NCT00165464|"     This is a phase II study of taxotere, cisplatin and irinotecan (CPT-11) used in combination     to treat metastatic esophageal and gastric cancer in an effort to see what effects (good and     bad) the combination may have on the patients cancer.   "
177595|NCT00165477|"     - The purpose of this study is to find out if the combination of lenalidomide and radiation     therapy is effective in controlling tumor growth in patients with newly-diagnosed     supratentorial glioblastoma or gliosarcoma.   "
177596|NCT00165490|"     The purpose of this study is to find out what effects (good and bad) the combination of three     chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when     given with radiation therapy.   "
177597|NCT00165503|"     The purposes of this study are: to determine the feasibility of administering adjuvant     cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery;     to determine the effects (good and bad) of this combined modality approach in patients with     mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is     excreted in the body from the collection of tissues and cisplatin samples; to collect and     analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic     make-up of the disease.   "
177598|NCT00165516|"     The purposes of this study are: to evaluate the effects (good and bad) that administering     heated cisplatin into the chest and abdomen cavity following surgical resection has on     malignant mesothelioma; to collect data on the toxicity of cisplatin given directly into the     chest and abdomen, and the levels of the cisplatin in the body; to determine if this     treatment method has the possibility of helping patients with pleural mesothelioma live     longer; and to determine if this treatment method can help decrease the rate of local     recurrence of mesothelioma.   "
177599|NCT00165542|"     The purpose of this study is to evaluate the sensitivity and specificity of A-PROTEIN     levels in patients with brain tumors. A-PROTEIN levels will be analyzed both pre and post     treatment. Levels in blood and/or cerebrospinal fluid (CSF) will be analyzed and correlated     with the underlying diagnosis and outcome.   "
177600|NCT00165555|"     The purpose of this study it to determine the safety and maximally tolerated dose (MTD) of     cisplatin administered in the operating room and put into the chest and abdomen for one hour.     We are also looking at the effects of heating the chemotherapy to a temperature of 42 degrees     celsius.   "
177601|NCT00165568|"     The purpose of this study is to investigate whether bevacizumab helps 5-Fluorouracil (5-FU)     be delivered to the tumor more efficiently. Bevacizumab has been shown to inhibit the     formation of new blood vessels in tumors and works best in combination with drugs that     require blood vessels for transportation. Based on other experiments, bevacizumab may work by     improving the transportation of other drugs to the tumor.   "
177602|NCT00165581|"     The purpose of this study is to understand the side effects (skin reaction, infection and     abscess formation) at the site of radiation treatment, which my occur during the treatment     and following 2 months using a new method of radiation therapy for breast cancer.   "
177603|NCT00165594|"     Phase I study:      To investigate primary objective (maximal tolerated dose and dose-limiting toxicity) and     secondary objectives (pharmacokinetics, safety, estimation of a recommended dose, and     anti-tumor effect by evaluable case) of E7070 in patients with gastric cancer who are     extensive or intermediate metabolizer type (EM/IM) to CYP2C9 and CYP2C9 by intravenously     administering once every 3 weeks.      Phase IIa study:      To investigate primary objective (response rate for efficacy assessment) and secondary     objectives (frequency and severity of adverse drug reactions, and pharmacokinetics) of E7070     in patient with gastric cancer who are EM/IM type by intravenously administering once every 3     weeks.   "
177604|NCT00165607|"     To investigate a new incidence and preventive effect of menatetrenone on vertebral fracture     in patients with osteoporosis who were randomly assigned to either treatment arm receiving     daily dose of calcium supplement as a monotherapy (calcium monotherapy group) or     menatetrenone plus calcium supplement as a combination therapy (menatetrenone combo therapy     group) for 36 months, followed by a 12-month follow-up observation to examine the preventive     effect on the fracture risk.   "
177605|NCT00165620|"     To establish the optimum injection rate for E7337 (Iomeron 350) in dynamic CT in patients who     have hepatic lesions.The primary endpoint for efficacy is the contrast enhancement effect in     the early arterial phase, and the primary safety endpoints are warming sensation and vascular     pain.   "
177606|NCT00165633|"     The purpose of this study is to determine the superiority of inhibitory effects and safety of     Menatetrenone (E0167) on recurrence in patients with hepatocellular carcinoma.   "
177607|NCT00165646|"     To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of     E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux     disease in a multicenter, randomized, double-blind, comparative study.   "
177608|NCT00165659|"     To evaluate the dose-response efficacy of E2020 (5 mg/day and 10 mg/day) versus placebo and     verify superiority of E2020 to placebo in patients with severe AD using CIBIC-plus* and SIB**     as the primary efficacy measures. Safety of E2020 will also be evaluated.      (*for overall evalution of clinical symtoms) (**for cognitive function test)   "
177609|NCT00165672|"     To investigate esophageal reflux condition in patients with non-erosive gastroesophageal     reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week     treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).   "
177610|NCT00165685|"     To investigate the efficacy and safety of KES524 in patients with obesity (visceral fat     obesity with type 2 diabetes and dyslipidemia), a 52-week, double-blind, placebo-controlled     comparative study is conducted. This study aims to examine superiority of KES524 to placebo     by employing change and percent change in body weight (primary endpoints) and changes in     proportion of subjects achieving ≧ 5% weight reduction, BMI, waist circumference, visceral     fat area, subcutaneous fat area, V/S ratio by abdominal CT scan, HbA1c, TG and HDL-C     (secondary endpoints).   "
177611|NCT00165698|"     To determine the effect and safety of menatetrenone on treatment of postmenopausal     osteoporosis comparing with alfacalcidol.   "
177612|NCT00165711|"     Patients who fit the inclusion criteria are admitted into the study. They are given 3 IV     injection of MBL in the first week and one tablet three times a day for 16 weeks.   "
177613|NCT00165724|"     Open study for efficacy and safety of donepezil treatment during 48 weeks   "
177614|NCT00165737|"     Twenty-four week, prospective, randomized, double-blind, placebo-controlled, parallel-group     study.   "
177615|NCT00165750|"     This study investigate the relationship between regional brain volume measured by MRI and     donepezil treatment response in patients with Alzheimer's Disease.   "
177616|NCT00165763|"     The purpose of this study is to examine the efficacy and safety of cholinesterase inhibitor     (donepezil hydrochloride) Aricept in patients with vascular dementia (VaD).   "
177617|NCT00165776|"     To evaluate efficacy and safety of E2014 (2500U, 5000U, 10000U, placebo) in a multicenter,     randomized, double-blind, parallel group comparative study by intramuscularly administering     to patients with spasmodic torticollis. Primary endpoint for efficacy evaluation is changes     in TWSTRS total scores from baseline measured at Week 4 and the clinical recommended dose     will be examined with Williams multiple comparison. For safety evaluation, an inter group     comparison (active drug and placebo) will be performed mainly focusing on incidence of     adverse events, adverse drug reactions, and abnormal changes in laboratory parameters.   "
177618|NCT00165789|"     This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects     will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and     receive treatment for a total of ten weeks (Days 1 to 70).   "
177619|NCT00165802|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 after     bolus IV administration, on Day 1 of a 21-day cycle, to patients with advanced solid tumors     that have progressed following effective therapy or for which no effective therapy exists.   "
177620|NCT00159757|"     There has been evidence that ziprasidone is efficacious in decreasing the magnitude of both     positive and negative symptoms of schizophrenia, and also effective in the treatment of     depressive symptoms. It shows good tolerance with low incidence of extrapyramidal side     effects and does not significantly influence body weight. As it has been shown that     ziprasidone is efficacious and safe in patients who have been pretreated with other     antipsychotic that has to be withdrawn either due to the side effects or not satisfied     efficacy. The purpose of the study was to provide further evidence for the efficacy and     safety of patients with schizophrenia and allow for psychiatrists in Hungary to gain     experience with the drug before wide commercial availability.   "
177621|NCT00159770|"     Evaluation of the antipsychotic efficacy and safety of ziprasidone versus olanzapine,     risperidone or quetiapine in patients with schizophrenia, schizoaffective and     schizophreniform disorders under naturalistic conditions of clinical practice   "
177622|NCT00159783|"     Bipolar disorder is characterized by mood swings that range from from high (manic) to low     (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed     episodes). Asenapine is an investigational medication for the treatment of manic or mixed     episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension     study) could continue with the same treatment that they had been receiving: asenapine or     olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40     -week continuation study.   "
177623|NCT00159796|"     Bipolar disorder is characterized by mood swings that range from high (manic) to low     (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed     episodes). Asenapine is an investigational medication for the treatment of manic or mixed     episodes of bipolar disorder. This is a 3-week study that will test the safety and efficacy     of this medication. Participants will receive either asenapine, olanzapine (a medication that     is already approved for the treatment of bipolar mania), or placebo (no active medication).     Participants will be required to stay in the hospital for at least the first seven days of     treatment. Participants who complete the 3 week study may be eligible to continue in     extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.   "
177624|NCT00165815|"     A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.   "
177625|NCT00165828|"     Patients with focal epileptic seizures with or without generalization who are at present     treated with one or two antiepileptic drugs are eligible for this study, provided that they     fulfill all inclusion criteria and none of the exclusion criteria. Following a baseline phase     of 8 weeks duration, the patients are randomised and they receive an initial daily dose of 50     mg zonisamide during the first week. The daily dose is then increased to 200 mg zonisamide in     group A or 400 mg zonisamide in group B, respectively. After eight weeks of treatment, the     daily dose in group A can be increased to 300 mg in case of insufficient efficacy. Control     assessments are performed at the beginning of the study and at the end of the prospective     baseline phase, if applicable and after 4, 8, 12, and 16 weeks. At the end of the first,     second, and third treatment week, and at the end of week six, the patient is additionally     contacted by telephone. Efficacy and safety parameters are assessed at baseline, during all     control visits, and at the end of the study.   "
177626|NCT00165841|"     The purpose of this study to determine the efficacy of 20 mg of rabeprazole given as a     maintenance intermittent therapy following acute treatment for Symptomatic Gastroesophageal     Reflux Disease (s-GERD).   "
177627|NCT00165854|"     Part 1: The primary purpose is to determine the recommended dose of E7070 in combination with     capecitabine by dose adjustment. Part 2: The primary purpose is to determine the safety and     efficacy of the combination in patients with metastatic CRC resistant to 5-fluorouracil and     irinotecan.   "
177629|NCT00165880|"     The overall purpose of this study is to compare the efficacy, safety and tolerability of     indisulam in combination with capecitabine (IC) versus capecitabine (C) monotherapy in     patients with metastatic breast cancer who have previously been treated with an anthracycline     and a taxane.   "
177630|NCT00165893|"     This study is looking at a new machine called the Accu-Spina which administers internal disc     decompression by following a computer program. This non-surgical treatment (similar to     traction) is being compared to a rigorous physical therapy program.   "
177631|NCT00165906|"     Children having open heart surgery must be on a heart-lung bypass machine. It is essential     that the blood in the heart-lung machine does not clot. This is accomplished by giving a drug     called heparin, a blood thinner.      The process of making a clot involves a lot of steps. One of the steps involves a protein     called thrombin. Heparin acts on thrombin to keep blood from clotting. A technique has been     developed to measure the blood's ability to generate thrombin. The bloods's ability to     generate thrombin is measured by a thrombin generation curve (TGC). This curve would be very     helpful to know when choosing the dose of heparin. We haven't found any studies using TGC in     babies less than a month old.      We want to do a study comparing the TGC in 10 newborns without a heart defect to the TGC in     10 newborns with a congenital heart defect. To do this we will need one sample of blood. the     sample we need is 3 cc which is a little more than 1/2 teaspoon. The blood sample for both     groups is to be taken from the intravenous catheter (IV) the child will have placed for     surgery. The newborns without a heart defect will be children having surgery for a     non-cardiac problem.   "
177632|NCT00165919|"     The purpose of the study is to investigate the immune response to hepatitis C virus to     determine why some people clear the virus and others develop chronic infection. Changes in     immune response once hepatitis C therapy is begun will also be examined. If patients are also     HIV+, the effect of antiretroviral therapy on the recovery of hepatitis C immunity will be     investigated.   "
177633|NCT00165932|"     At Children's Healthcare of Atlanta, children who have irregular heart rhythms are often     referred for evaluation. Sometimes they also need a procedure to correct their irregular     heart rhythm. An echocardiogram is routinely used as part of their evaluation and follow-up.     The echocardiogram including Tissue Doppler Imaging (TDI) works by bouncing sound waves off     the heart similar to radar. A new echocardiogram technology, Tissue Synchronization Imaging     (TSI), should help doctors look at heart function compared to heart rhythm. All three of     these are noninvasive, which means they work from a probe outside the body and are not     painful.      The purpose of this study is to see how Tissue Synchronization Imaging works in patients with     heart rhythm problems. We will use patients who have a heart irregularity. We will also look     at children and young adults with normal heart function to establish normal values for TSI.      All pediatric patients we approach for this study will receive an echocardiogram recommended     by their cardiologist (standard of care), plus TSI, a new part of a heart ultrasound The     young adult population will undergo a heart ultrasound plus TSI. This young adult population     will be selected from medical students at Emory University. During the consent process, the     medical students will be informed that participation is voluntary and if they decide not to     participate, it will not affect their grades, etc.   "
177634|NCT00165945|"     In this study, the investigators wish to use images obtained from standard of care cardiac     MRI's performed at Children's Healthcare of Atlanta and transfer the images to a different     computer in order to analyze them with a new computer. The investigators are hoping to better     their understanding and management of complex congenital heart disease.   "
177635|NCT00165958|"     The purpose of this trial is to compare two standard of care treatments for removing     epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the     skin. A punch incision makes a smaller hole through which the cyst can be removed. The     trial's purpose is to determine if one method is better than another in terms of recurrence,     infection, or other side effects.   "
177636|NCT00165971|"     General anesthesia allows people to have surgery without experiencing the procedure or pain.     To remain unconscious, the depth of sleep must be monitored. Various monitors have been     developed, one of which is BIS (short for bispectral index). BIS monitors the level of sleep     during anesthesia and improves patient recovery because the amount of sleep drugs can be     fine-tuned to the individual. Patients who need a lot to stay asleep get more, and those who     need less get less. As a result, patients tend to wake up faster with BIS monitoring as     compared to standard practice not using BIS. Little is known about the long-term effects of     BIS monitoring. This study investigates whether BIS monitoring during anesthesia improves     long-term outcome, well after surgery is over. The hypothesis is that it does. Two groups of     patients are compared: one in which BIS monitoring was used, and one in which it was not.     Groups are compared on tests of memory, concentration and mental well-being, to see if one     does and feels better than the other. The investigators also take blood samples to see how     well patients' bodies deal with the surgery. The investigators expect the BIS monitoring     group to do better.   "
177637|NCT00165984|"     There are many kids born with congenital heart disease. Some of these defects may lead to the     formation of a single ventricle (the heart having only one pumping chamber). These children     normally undergo a series of corrective surgeries to help overcome the problems of having     just one ventricle. However there are some differences in how well the patients respond to     the surgeries. In the adult population, studies have shown that there may be a genetic link     that may be responsible for the differences in how patients respond. The investigators would     like to study the pediatric population by looking for certain genetic markers in the     patients' blood. They will also collect basic health information on each patient.   "
177652|NCT00167934|"     This study will determine the metabolic processes responsible for high levels of blood     glucose, metabolism disorders, and weight gain in people with schizophrenia who have been     treated with antipsychotic medications in combination with valproate.   "
177653|NCT00167947|"     Renal function at 12 months assessed by calculated creatinine clearance.   "
177654|NCT00167960|"     To determine the impact of the restriction of the third and forth generation cephalosporins     on the reduction of intestinal colonization or infection with vancomycin-resistant     enterococci (VRE) in a surgical intensive care unit (SICU)   "
184605|NCT00259402|"     -  To determine the activity and efficacy of the schema specified as dose regimen        -  To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU   "
177638|NCT00165997|"     Radiofrequency ablation is a procedure done in the Catheterization Laboratory to help correct     specific problems that cause the heart to beat faster than it should. Quality of life     includes the physical as well as the emotional aspects of a patient. Doctors have always     tried to take care of a medical problem with minimal physical and emotional risk. It is     assumed that once the medical problem is fixed, the patient will have an improved quality of     life. To know if this assumption is true, the investigators are asking children scheduled for     this procedure, along with their family, to answer questions before the ablation, then answer     the same questions 5-6 months after the ablation.   "
177639|NCT00166010|"     Children with severe heart failure need immediate appropriate care. New and better drugs are     constantly being developed. As these drugs are approved for adult use, they are used     off-label for children. The Food and Drug Administration (FDA) encourages clinical studies of     drugs in children to further extend appropriate use of new medicines.      This study involves nesiritide, which was approved as a congestive heart failure treatment in     adults in August 2001. The investigators' use of this drug in a pediatric population with     severe heart failure has been encouraging. The investigators now wish to formally determine     the pharmacokinetic and safety of Nesiritide in children.      The investigators will enroll 30 patients who are in the cardiac intensive care unit with     severe heart failure. The data collected will include weights, vital signs, laboratory     results, and echocardiography results. A research lab test called B-type natriuretic peptide     (BNP) will be done several times during this study. If the patient still has an intravenous     (IV) catheter, the blood sample will be taken from the IV. If the patient does not have an     IV, the sample will be taken from a fingerstick.      The duration of the study will be the first 2 days of the patient's stay in the cardiac     intensive care unit and thru discharge to evaluate the endpoint safety of Nesiritide.     Additional information will also be collected if patient gets re-admitted within 30 days of     discharge.   "
177640|NCT00166023|"     Infective endocarditis is a rare disease, and while there have been several large reviews of     the incidence of endocarditis in the pediatric patient population, relatively little has been     published regarding the short and medium-term outcomes following medical and surgical therapy     for this disease. The goal is to compare the outcome for children treated for endocarditis     with either medical management or surgery by looking at the success of these two treatment     strategies. Another goal is to attempt to identify risk factors for medical management that     might identify patients who would be better served by early surgery.   "
177641|NCT00166036|"     Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were     randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily.     Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid     reactive substances [TBARS], and aminothiol levels) and brachial artery flow-mediated     dilation (FMD) were measured at baseline and after 12 weeks of statin therapy.   "
177642|NCT00166049|"     The purpose of the Education and Supportive Partners Improving Self-Care (ENSPIRE) study is     to compare the effect of a Family Partnership Intervention (FPI) over patient and family     education and usual heart failure care on physical and mental health outcomes over an 8-month     period. The study will examine three ways of giving heart failure patients and their family     members information. This study will help scientists determine if learning these     communication skills will help people with heart failure to better manage their symptoms and     improve their health outcomes.   "
177643|NCT00166062|"     The purpose of this study is to see if using a computer kiosk to screen men and women for     intimate partner violence victimization and perpetration is safe and effective. We     hypothesize that screening will not result in any adverse events.   "
177644|NCT00166075|"     Using a touch screen computer, the researchers are screening emergency department patients     for intimate partner violence and mental health issues.   "
177645|NCT00166088|"     Problem of Interest:      A typical American diet that is high in an intake of fats (especially saturated fats and     cholesterol) is known to lead to high blood levels of cholesterol, hardening of the arteries,     and increases the risk of heart disease. The American Heart Association recommendations to     follow a diet that is low in the amount of fat, and specifically cholesterol, that is eaten     can improve blood levels of cholesterol but can lead to a high intake of sugars (especially     processed sugars) that can lead to obesity and continued heart problems.      Studies of people who eat a diet that is typical of the Mediterranean region have shown that     this type of diet leads to reductions in heart disease as well as forms of cancer. A typical     Mediterranean diet has a large amount of fruit, vegetables, whole grain breads and cereals,     beans, potatoes and seeds. Olive oil is the main source of fat and there is a daily use of     dairy products (such as cheese and yogurt) in low to moderate amounts. The main meats are     fish or poultry with rare red meat. Desserts are usually fruits with rare sweets. Wine is     also used in low to moderate amounts with meals.      No isolated aspect of the diet explains all of its benefits, but it is believed that the     ingredient of the diet that most helps to reduce the risk of heart disease is the high amount     of omega-3 fatty acids. Omega-3 fatty acids are found in fatty fish as well as in nuts and     certain oils. Several studies of patients with either known heart disease or risk factors for     heart disease have shown a reduction in heart disease events, such as heart attacks, as well     as markers of heart disease risk when patients followed a Mediterranean diet. Other studies     have shown that giving a supplement that contains omega-3 fatty acids to patients with heart     disease or risk factors for heart disease also reduces heart disease events and markers of     heart disease risk.      In this current study we, the investigators at Emory University, plan to compare the effects     of following a Mediterranean diet versus continuing to follow an American type diet and     supplementing parts of the Mediterranean diet, including omega-3 fatty acids, on markers of     heart disease risk. A third group will continue to follow their usual diet without     supplements to serve as a control.      How Problem Will be Studied:      In this initial study we will compare three groups. One group will receive one month of     prepared meals that will follow a Mediterranean diet. This group will also receive extensive     counseling and education on how to maintain a Mediterranean diet. During the second month of     the study this group will be encouraged to continue following a Mediterranean diet by     themselves with assistance from a nutritionist. The second group will be asked to continue on     their current diet and receive supplements that are important parts of the Mediterranean     diet. These supplements will include an omega-3 fatty acid capsule, walnuts and grape juice.     A third group will be asked to continue their current diet and level of activity without     supplements to serve as a control. We will follow the effects on markers of heart disease     risk. We will also determine if patients are able to continue following a Mediterranean diet     on their own or whether simply taking supplements is easier.      Advancement in Scientific Knowledge:      This study will advance scientific knowledge by comparing the effects of following a     Mediterranean diet versus simply taking supplements of the believed to be important aspects     of the Mediterranean diet. We will also be able to determine if it is easier to follow a     Mediterranean diet or take supplements for patients who are currently ingesting a typical     American diet.      Standard of Care:      Currently the recommended diet for all Americans is a Step 1 American Heart Association diet     that is low in fat and specifically low in saturated fats and cholesterol. As stated above,     despite these recommendations, there is a growing problem of obesity in the United States and     there is evidence to suggest that a Mediterranean diet may be better.   "
177646|NCT00166101|"     Due to the small size of infants and the use of bypass machines, physicians have difficulty     assessing whether the infant's brain and body is getting enough oxygen during heart surgery.     This study compares continuous monitoring via the NIRS (Near Infrared Spectroscopy) to the     traditional methods of determining oxygen saturation.   "
177647|NCT00166114|"     Men and women who have suffered sexual and/or physical abuse before the age of 12 are at     increased risk for anxiety and mood disorders, other serious psychiatric disorders, and     likely medical illnesses. What is not known is whether adult survivors of childhood adversity     experience heightened negative emotions and increased physical responses due to altered     norepinephrine or serotonin systems in their brains and bodies. The investigators expect to     see that survivors of childhood adversity experience heightened negative emotions and     increased physical responses to stress.   "
177648|NCT00166127|"     The purpose of this study protocol is to evaluate the blood concentrations of levosimendan     when administered at different doses clinically employed during cardiopulmonary bypass or     cardiac manipulation during off pump surgery in patients who require the drug for inotropic     support (improved heart function) and the associated hemodynamic variables (vital signs).     Levosimendan is one of the first agents in a new class of drugs used to treat heart failure     and works via a unique mechanism called calcium sensitization, that makes the heart beat more     efficiently. Levosimendan also has unique effects on the blood vessels, as well as causing     relaxation, an important therapeutic approach of heart failure therapy.   "
177649|NCT00166140|"     Heparin is an anticoagulant or blood thinner. Heparin is always given to patients     undergoing open-heart surgery to prevent blood from clotting when a patient is placed on the     heart-lung machine. Heparin works by combining with a protein in blood to prevent other     proteins from working together to form a clot. The protein that heparin combines with seems     to be different in infants and young children compared to adults.      The purpose of this study is to determine which proteins in children have a direct impact on     the way heparin works. We also want to see how this may change at different ages. We will     enroll two age groups of children; birth to 2 years and 10 years or older. A total of 125     patients will be enrolled into this study. These patients will already be scheduled for     open-heart surgery using a heart-lung machine.      The testing involves taking blood samples when the patient is asleep for surgery; and later     from their intravenous line, IV. They will all have IV's in place already because of the     surgery. Therefore the study will cause no pain or discomfort for the patients who take part.   "
177655|NCT00167973|"     This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX.     All patients who begin treatment with BeneFIX in European Union countries, will be eligible     for participation. Patient demographics will be collected at baseline for all patients. A     baseline FIX activity and Bethesda assay for inhibitor based on historical data should be     recorded if available. Adverse events as defined in the protocol will also be reported on the     appropriate forms. Data will be collected from patients on an ongoing basis to ensure that     information is being captured for each patient being treated with BeneFIX.   "
177656|NCT00167986|"     To determine whether the restriction of 3rd generation cephalosporins and carbapenems     contribute to the reduction of intestinal colonization or infection with vancomycin-resistant     enterococci (VRE) in a medical intensive care unit (MICU).   "
177657|NCT00167999|"     To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and     restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing     Escherichia coli and Klebsiella pneumoniae in hematology and oncology units   "
177658|NCT00168012|"     The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of     serious bacterial infections in patients with primary immunodeficiency.      As secondary endpoints the rate of overall infections, the tolerability and safety of     IVIG-F10 are studied.   "
177659|NCT00168025|"     The purpose of this study is to demonstrate the effect of IgPro10 on the prevention of     serious bacterial infections in patients with primary immunodeficiency.      As secondary endpoints the rate of overall infections, the tolerability and safety of IgPro10     are studied.      A part of the patients are participating in a pharmacokinetic substudy.   "
177660|NCT00168038|"     The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in     the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main     efficacy parameter is the proportion of patients responding to treatment by an increase of     platelet count to ≥ 50 x 10^9/L.   "
177661|NCT00168051|"     The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate,     using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.   "
177662|NCT00168064|"     This study will evaluate the efficacy, tolerability and safety of the topical application of     mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).   "
177663|NCT00168077|"     Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of     acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a     fast reversal of the anticoagulant effect, with several advantages over alternatives like     vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically     relevant data on efficacy and safety.   "
177664|NCT00168090|"     The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent     bleeding in patients with von Willebrand Disease who are undergoing surgery.   "
177665|NCT00168103|"     HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not     treated adequately, the acute attacks of HAE can be life-threatening and may even result in     fatalities, especially in case of swelling of the larynx. This clinical Phase 2/Phase 3 study     was designed to provide clinically relevant data on dosing, efficacy and safety in subjects     with HAE.   "
177666|NCT00168116|"     The purpose of this study is to compare the side effects of radiation treatment and surgery     versus radiation alone, where no surgery is done to move the salivary gland and place it     under the chin region where it can be shielded from radiation.   "
177667|NCT00168129|"     To assess the safety and efficacy of a single fraction of radiotherapy using helical     tomotherapy to treat bone metastases.   "
177668|NCT00168142|"     To compare the two types of scans, the conventional CT planning scan and the tomotherapy     planing scan.   "
177669|NCT00168155|"     When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be     removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere     in the body. This study will determine if giving chemotherapy treatment before the surgery     can reduce the chances that the cancer will come back.   "
177670|NCT00168168|"     Evaluate recovery time on 2.5 mg/Kg/day dose of G-CSF versus 5 mg/Kg/day dose.   "
177671|NCT00168181|"     This is a study to see whether the drug Salagen or salivary gland transfer is better for the     prevention of dryness of the mouth in patients with head and neck cancer receiving radiation     treatment.   "
177672|NCT00168194|"     It remains unclear why some individuals are able to clear HBV from their bodies while in     others HBV is a persistent infection. We plan to investigate this process by collecting blood     and analysing how the patient's white blood cells respond to different pieces of the HBV     virus. We will use new tools that can precisely tell us which component of the immune     response may be different in individuals who are chronically infected with HBV and also in     individuals who are also infected with HIV.      The primary aims are therefore:        1. To characterize HBV-specific T cell responses in HBV chronic carriers, and identify          novel immunogenic regions in both HLA-A2+ and non-HLA-A2+ individuals.        2. To determine the effect of HIV infection on HBV-specific T-cell responses   "
177673|NCT00168207|"     The aim is to investigate the hypothesis that IL7-receptor polymorphisms contribute to the     differential immune recovery of CD4 + T cells following HAART   "
177674|NCT00168220|"     A case-control study to look at hypersensitive and tolerant individuals matched for HLA     genetic predisposition, when considering predictors of drug hypersensitivity.The study aims     to identify the immunological factors increasing the risk of drug reactions in HIV positive     individuals.   "
177675|NCT00168233|"     To investigate the effect of treatment of HIV infection with highly active antiretroviral     therapy on individual steps of reverse cholesterol transport, endothelial function and     intima-media thickness in HIV patients.   "
177676|NCT00168246|"     This study will determine the prevalence of HIV-related neurological disorders in the     countries of the Asia-Pacific Region.   "
177677|NCT00168259|"     The study is designed to evaluate interferon responses to CMV in HIV positive individuals and     a component will look at interferon responses to CMV in HIV positive individuals over time     after commencement of antiretroviral therapy. We will also look at the correlation between     CD4 T cell numbers and HLA type with the interferon response.   "
177678|NCT00168272|"     The purpose of this study is to assist in understanding the most effective parameters for TMS     in Depressive Disorders. Most research conducted has used high frequency stimulation on the     left hemisphere.However, low frequency on the right hemisphere has also been shown to have     antidepressant properties and appears to be better tolerated. A promising approach to improve     responses to rTMS may be to combine high and low frequency stimulation where they are both     applied to the right side of the brain. In this approach, high frequency stimulation is     provided first which may 'prime' or pre-prepare the brain for low frequency stimulation in a     way that enhances its response. Participants are randomised to receive active or placebo     priming stimulation.If participants do not respond to this treatment condition after 10     sessions applied over a two week period they will be offered 10 session of high frequency     left sided TMS treatment. Alternatively, if participants respond favorably they may continue     with that treatment condition for another 10 sessions.   "
177679|NCT00168285|"     Interstitial lung disease (ILD) is a highly disabling group of conditions including     idiopathic pulmonary fibrosis (IPF), acute and chronic interstitial pneumonias, connective     tissue diseases and sarcoidosis. People with ILD frequently experience breathlessness on     exertion, which limits their ability to undertake daily activities. People with ILD report     very poor quality of life due to low levels of physical functioning and vitality, and high     levels of breathlessness and fatigue. There are few treatments for ILD and those that are     available have limited impact on quality of life.      The aim of this study is to assess the effects of Pulmonary Rehabilitation, which consists of     specialised exercise training for people with lung disease, on exercise capacity and quality     of life in people with ILD. We hypothesis that exercise training will result in reduced     dyspnoea, improved exercise tolerance and enhanced quality of life.   "
177680|NCT00168298|"     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone     for the treatment of macular edema associated with retinal vein occlusion.   "
177681|NCT00168311|"     There is pilot data to suggest the therapeutic value of rTMS applied to the left prefrontal     cortex in the treatment of negative symptoms. Neuroimaging studies demonstrate abnormal     activity in this region in patients experiencing negative symptoms. Finally rTMS applied at     high frequency shows the capacity to up-regulate cortical activity in a way that would     provide an explanation for a therapeutic response.      The study involves participants receiving 15 sessions of high frequency rTMS treatment     applied bilaterally to the prefrontal cortex over a 3 week period or sham rTMS. Following     this double blind phase, participants randomised to placebo treatment will be offered 15     sessions of active treatment.      In addition, ppTMS (paired pulse TMS) will be conducted prior to the onset of treatment and     after completion of the course, as a means of measuring cortical inhibition and facilitation.     NIRS (Near Infra red spectroscopy) will also be conducted prior to, during and after the     first and last treatment sessions to allow monitoring of oxygenated and deoxygenated     haemoglobin.   "
177682|NCT00168324|"     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone     for the treatment of macular edema associated with retinal vein occlusion.   "
177683|NCT00168337|"     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone     for the treatment of diabetic macular edema.   "
177684|NCT00168350|"     Randomized double-masked clinical trial of memantine in patients with glaucoma   "
177685|NCT00168363|"     This Study will evaluate the safety and efficacy of brimonidine in patients with glaucoma or     ocular hypertension   "
177686|NCT00168376|"     The study will involve a 3-week (15 session) randomized double-blind clinical trial of two     repetitive transcranial magnetic stimulation (rTMS) conditions in patients with treatment     resistant depression. rTMS site selection will be localized from structural MRI scans.      The patients will be randomized to one of two conditions        1. rTMS targeted to the border of Brodmann area 46 and Brodmann area 9,        2. rTMS targeted to premotor cortex (this condition will act as the non-dorsolateral          prefrontal cortex targeted control).   "
177687|NCT00168389|"     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone     for the treatment of diabetic macular edema.   "
177688|NCT00168402|"     This is a three-year study in subjects with axillary hyperhidrosis involving injection of     Botulinum Toxin Type A into the axilla to reduce sweating.   "
177689|NCT00168415|"     A study using Botulinum Toxin Type A in adolescents with axillary hyperhidrosis.   "
177690|NCT00168428|"     This is a 60 week study including a double-blind phase followed by an open-label phase.   "
177691|NCT00168441|"     4-month study including a 30-day baseline phase   "
177692|NCT00168454|"     The purpose of this study is to investigate whether injections of botulinum toxin Type A into     the bladder are safe and effective in treating overactive bladder.   "
177693|NCT00168467|"     One important clinical challenge in older individuals is maintaining mobility in the absence     of pain. Peripheral arterial disease affects up to 12% of adults over 50 and impairs quality     of life due to intermittent claudication causing pain and limiting mobility.      Conventional therapies have only modest effect in improving symptoms. The investigators     hypothesise that angiotensin converting enzyme inhibition (with ramipril), which causes     arterial vasodilation, also improves clinical symptoms in patients with peripheral arterial     disease.   "
177694|NCT00168480|"     This is a three year open-label study in subjects with axillary hyperhidrosis.   "
177705|NCT00168623|"     Vitamin A supplementation (VAS) is important for the immune system and may interact with     different childhood vaccinations. We have hypothesized that the improved survival after VAS     may depend on vitamin A amplifying the non-specific immune modulation induced by     vaccinations.      In the present study we used information collected in connection with a national vitamin A     campaign in Guinea-Bissau during which different doses of VAS was provided together with     missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential interactions     between VAS and vaccine type.   "
177768|NCT00169468|"     The primary objective of this study is to evaluate the response rate and toxicity of the     association R-CHOP with two schedules of administration of Velcade, in B-cell CD 20 +     lymphoma patients, aged from 18 to 80 years      The goal is to get a response rate at least at what observed with R-CHOP alone and will be     evaluates with a sequential test.      The other objective is to evaluate the toxicity   "
177695|NCT00168493|"     We aim to determine why patients with depression are at an elevated risk for the development     of coronary heart disease, and resolve whether the severity of a patient's depression has a     counterpart in demonstrable abnormalities in brain chemistry. Studies will be completed in 28     patients with depression; both males and females. Patients will be studied both untreated and     during administration of a selective serotonin re-uptake inhibitor (SSRI) antidepressant.     They will be either newly diagnosed with depression, untreated patients suffering a recent     relapse, or patients seeking to switch from a non-SSRI antidepressant due to non-response.     The turnover of chemical messengers in the brain will be estimated by high internal jugular     venous blood sampling and DNA will be isolated and examined from blood cells. Immune function     will also be assessed. Whole body and cardiac sympathetic nervous activity will be     determined, as well as microneurographic recording of muscle sympathetic nervous activity.      It is hypothesised that patients with depression and no existing demonstrable cardiac disease     demonstrate:      Alterations in brain monoaminergic neurotransmitter turnover, resulting in sympathetic     nervous activation and dysregulation of the baroreflex control to both the heart (vagal) and     muscle vasoconstrictor sympathetic nerves; and Exhibit enhanced platelet reactivity     predisposing them to thrombogenesis and myocardial ischaemia.      Therapeutic intervention with an SSRI will modify cardiac sympathetic function, baroreflex     sensitivity or platelet reactivity in a fashion likely to reduce cardiac risk.   "
177696|NCT00168506|"     The reason for increased cardiac mortality in panic disorder has not been precisely     identified, but possibly is due to chronic activation of the cardiac stimulant (sympathetic)     nerves, which may predispose the individual with panic disorder to disorders of cardiac     rhythm and coronary artery spasm. The uniqueness of this study lies in its comprehensive     evaluation of a psychobiological approach to the treatment of panic disorder using change in     biological, behavioural and psychological variables as criteria for efficacy. 50 patients     aged between 18 and 60 years will be recruited; both males and females. They will be treated     with either cognitive behavioural therapy (CBT) or SSRI (selective serotonin re-uptake     inhibitor) antidepressants or a combination of both.      This project will firstly compare individuals with panic disorder who demonstrate abnormal     brain transmitter (noradrenaline, serotonin) with those who demonstrate normal activity of     these neurotransmitters, on interoceptive accuracy for changes in sympathetic nervous system     arousal. It is predicted that individuals who demonstrate abnormal activity of these     neurotransmitters will also demonstrate enhanced interoceptive ability to detect changes in     arousal levels. Secondly, this project will evaluate the effects of a psychobiological     treatment approach to panic disorder involving a combination of CBT and SSRI. This approach     will be compared to the effects of both these interventions alone on a comprehensive array of     measures related to panic disorder. It is predicted that the combined approach will be the     most effective intervention on behavioural, psychological and biological variables, and     cardiac risk. We will also be able to assess whether changes in panic disorder severity are     associated with changes in interoceptive accuracy.   "
177697|NCT00168519|"     The purpose of this project is to determine whether glucose metabolism can be improved by     administering a substance (nitric oxide donor) normally released by muscles during exercise.   "
177698|NCT00168532|"     Objective It is the objective to test whether the use of prophylactic antibiotics in measles     infection will reduce the incidence of post-measles pneumonia and/or admissions to hospital     with 50%. The possible impact on other complications of severe measles will also be measured.   "
177699|NCT00168545|"     OBJECTIVES        -  General: To investigate the immunological background for the non-specific effects of          diphtheria-tetanus-pertussis (DTP) and measles vaccines on child mortality        -  Specific: Examine the cytokine responses and possible association with morbidity in a          study of DTP vaccinated children who will be randomised to receive a measles vaccine or          no vaccine at 4½ months of age. (All children will receive a measles vaccine at 9 months          of age)   "
177700|NCT00168558|"     The specific aims are to examine in Guinea-Bissau:        -  whether the standard titre Schwarz (SW) or standard-titre Edmonston-Zagreb (EZ) measles          vaccine will be the best vaccine strain for use in a routine one-dose measles          vaccination schedule and a two-dose measles vaccination schedule in terms of antibody          response, protection against measles and child survival, and        -  whether the standard-titre Edmonston-Zagreb (EZ) vaccine will be suitable for use in a          very early two-dose schedule vaccinating at 4½ and 9 months of age   "
177701|NCT00168571|"     Few data exist on long-term persistence of measles antibodies after vaccination of West     African infants. The data that do exist indicate that the antibody titres decline very     rapidly. Our data would be the first to describe the persistence of measles antibodies after     two doses of measles vaccine, and the study would allow us to identify unprotected children     and offer them revaccination. Since persistence of measles antibodies is of crucial     importance to measles control, the study will contribute significantly to the existing     knowledge and might have important implications for future eradication programmes.   "
177702|NCT00168584|"     Vitamin A supplementation reduces all-cause mortality. It is therefore given with oral polio     vaccine in national campaigns. However, it is not clear which dose is optimal. The two     studies that have investigated the impact of different doses of vitamin A have both found     that a smaller dose was better than a large dose. We therefore investigated if a smaller dose     given with oral polio vaccine gives equal or better effect.   "
177703|NCT00168597|"     Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given     at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG     vaccination is associated with a 30% reduction in infant mortality and morbidity during the     first year of life in normal birth weight children in an African setting.   "
177704|NCT00168610|"     In the present study the investigators wish to address the effects of different doses of     vitamin A supplementation in low and normal birth weight infants.      Hypotheses:        -  Vitamin A supplementation administered at birth together with BCG vaccination is          associated with a 30% reduction in infant mortality and morbidity during the first year          of life in both normal and low birth weight infants.        -  A lower dose of vitamin A may be even more beneficial than a high dose.   "
177873|NCT00163085|"     To determine the effects of the NMDA antagonist, CP-101,606, in subjects with Parkinson's     Disease   "
177706|NCT00168636|"     We previously compared the effect on mortality of the half dose and the full dose currently     recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for     boys. The girls' response might have depended on the last vaccine received before the OPV and     VAS campaign. We believe that these findings call for confirmation. In connection with a new     campaign, we will examine whether half the dose or the full dose has a more beneficial effect     on mortality and morbidity in girls, and furthermore address the potential effect     modification by the last vaccine received before the supplementation.   "
177707|NCT00168649|"     Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after     infusion with endotoxin in several animal models. We intend to examine the effect of vitamin     A as pre-treatment on the response to endotoxin in humans. We furthermore wish to examine the     long-term effects of vitamin A on the response to endotoxin. We hypothesise that vitamin A     decreases endotoxin levels and TNF-alfa responses.   "
177708|NCT00168662|"     The general objectives of the proposed research work are:      A1) to reduce childhood mortality in developing countries through better control of measles     infection by finding the best immunization strategy, and A2) to investigate the hypothesis     that standard titre measles immunization is associated with non targeted beneficial effects     on childhood morbidity and mortality in developing countries.      The measurable, specific objectives of the present proposal are:      B1) to examine whether a two-dose strategy for measles immunization at 6 and 9 months of age     can reduce measles incidence by 50% through better coverage or improved seroconversion, and     B2) to examine whether a two-dose strategy for measles immunization at 6 and 9 months of age     can reduce childhood mortality by 20% through better coverage, better protection against     measles or non targeted beneficial effects, and B3) to determine the magnitude and duration     of non-measles related changes in morbidity patterns after standard titre measles     immunization, in particular to test whether measles immunization is associated with a 15%     reduction in the risk of diarrhoea, and B4) to determine non-measles related immunological     changes among recipients of measles vaccine in order to establish possible pathways for the     non targeted effects of standard titre measles immunization.   "
177709|NCT00168688|"     Prenatal maternal micronutrient supplementation has been suggested as a means to reduce the     proportion of low birth weight babies in low-income countries. The effects of prenatal     multi-micronutrient supplements on birth weight and perinatal mortality were studied in a     randomised controlled trial among 2100 pregnant women in Guinea-Bissau. Women up to 37 weeks     pregnant were individually randomised to daily supplements until delivery of A) Iron + folic     acid or multi-micronutrients in B) One or C) Two recommended dietary allowances. Secondary     outcomes were infant growth and maternal haemoglobin eight weeks after delivery.   "
177710|NCT00168701|"     Determine the efficacy,safety, and tolerability of BG00012 in MS patients.   "
177711|NCT00168714|"     The primary objectives of the study were to prospectively record and analyze birth defects     and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within     approximately 1 week of conception or during the first trimester of pregnancy, where the     outcome of the pregnancy was unknown prospectively and to prospectively record and analyze     pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy, but who     may have been exposed to Avonex with approximately 1 week of conception or during the first     trimester of pregnancy.   "
177712|NCT00168727|"     The purpose of this study is to determine the safety and effectiveness of a treatment regimen     using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin’s Lymphoma (NHL) or     relapsed Non-Hodgkin’s lymphoma and have been previously treated. This study will use an     experimental scheduling regimen. No chemotherapy will be used in this study.   "
177713|NCT00168740|"     Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them.     Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total     of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week     for 4 weeks. The patients' tumors were measured before and after treatment. Ten patients had     a complete response and 70 patients had a partial response to rituximab. The median duration     of response was 11.2 months.   "
177714|NCT00168753|"     To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.   "
177715|NCT00168766|"     The primary objective of this study is to determine whether combination treatment (adding     methylprednisolone to Avonex) reduces progression of disability over 4 years compared to     Avonex alone. The study will also investigate whether combination therapy has any impact on     the incidence of relapse and brain atrophy as measured by MRI.   "
177716|NCT00168779|"     The primary objective of this study is to compare the effectiveness of telmisartan 80 mg /     hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg / hydrochlorothiazide 25 mg     [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.   "
177717|NCT00168792|"     To show whether addition of thrombolytic treatment by a single bolus injection of     tenecteplase prior to early standard PCI (percutaneous coronary intervention) will improve     the clinical outcome in patients with large acute myocardial infarcts as compared to primary     PCI alone.   "
177718|NCT00168805|"     A phase III, randomised, parallel-group, double-blind, active controlled study to investigate     the ef ficacy and safety of two different dose regimens of orally administered dabigatran     etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on     the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days,     in prevention of venous thromboem bolism in patients with primary elective total knee     replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)   "
177719|NCT00168818|"     The objective of this study is to determine the comparative efficacy and safety of two oral     regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin,     in prevention of venous thromboembolism in patients with primary elective total hip     replacement surgery.   "
177720|NCT00168831|"     To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the     Respimat inhaler in patients with COPD.   "
177721|NCT00168844|"     To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the     Respimat inhaler in patients with COPD.   "
177874|NCT00163098|"     A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance     in patients with COPD   "
177722|NCT00168857|"     A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers     (ARB) have been shown to slow the decline in kidney function of patients with type 2     diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The     purpose of this research study is to determine if after one year of treatment telmisartan     (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg,     another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR)     100 mg in reducing the level of urinary protein (indicative of improved kidney function).   "
177723|NCT00168870|"     This study evaluates treatment with combination versus monotherapy for patients with     metastatic ocular melanoma.   "
177724|NCT00168883|"     This is a randomized study to assess the efficacy and safety of chemotherapy with platin     compared to chemotherapy without platin.   "
177725|NCT00168896|"     Comparison of two combination chemotherapies in the treatment of patients with SLCL   "
177726|NCT00168909|"     The purpose of this study is to evaluate the effect of alfacalcidol 1 µg daily on the number     of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women.      primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed     falls)   "
177727|NCT00168922|"     Determination of response rate Assessment of toxicity and determination of time to     progression   "
177728|NCT00168935|"     Background: Malnutrition is frequently occurring in sick patients and is associated with a     higher morbidity and mortality. Muscle dysfunction is a common finding in malnutrition which     leads to a reduced functional status and quality of life.      Specific aims: The purpose of the study is to evaluate the effect of a three month     nutritional intervention with oral supplements on nutritional status, muscle function and     quality of life.   "
177729|NCT00168948|"     - intermittent preventive treatment with SP in children to evaluate efficacy and safety of     this drug combination in children in northern Ghana   "
177730|NCT00168961|"     Malnutrition is frequently occurring in patients with liver cirrhosis and is associated with     a poorer outcome, as it determines life quality and affects both morbidity and mortality.      Long term prognosis after liver transplantation also depends on the nutritional status.      Therefore, the early diagnosis and intervention for malnutrition is an important issue in the     clinical management of liver cirrhosis. However, oral intake has been shown to be     insufficient due to disease related anorexia or concomitant drowsiness and confusion.      Specific aims: To investigate the effect of early nutritional intervention via tube feeding     on nutritional status, functional status (hand grip strength and peak flow), life quality and     disease related complications such as intestinal permeability, and oxidative stress, as well     as liver function.   "
177731|NCT00168974|"     Fabry disease is a rare X-linked lysosomal storage disorder. The mutations result in a     deficiency of the lysosomal enzyme α-galactosidase causing accumulation of glycosphingolipids     in the vascular endothelial cells and many other tissues. An early sign of the disease is     painful small fibre neuropathy presenting in two forms: 1. a constant burning sensation in     the hand and feet and 2. Fabry crises consisting of attacks of excruciating pain. Given the     X-linked inheritance, male patients are severely affected. Recently attention has been drawn     to female patients whether they also show signs of nerve involvement.      The purpose of this study is to evaluate the small fibre neuropathy in female Fabry patients.     Correlation with X-chromosome inactivation will be attempted. Recombinant human     α-galactosidase A is now available for patients. A part of this study is evaluation the long     term efficacy of enzyme replacement therapy in female patients with Fabry disease and     neuropathy.      Male family members with Fabry disease will be examined.   "
177732|NCT00168987|"     Malnutrition is a frequent symptom of various malignant diseases and is frequently observed     in patients with gastrointestinal tumors. Eicosapentanoic acid (EPA) has been introduced as     specific and anticatabolic acting substrate in cancer patients. Only few randomized trials     are available which investigated the effect of EPA in form of an EPA-enriched, protein- and     energy-dense oral nutritional supplement mostly in patients with pancreatic carcinoma.      Therefore, the effect of an EPA-rich oral nutritional supplement for two months on functional     state and quality of life in patients with other gastroenterological tumors and weight loss     is investigated in this randomized prospective trial.   "
177733|NCT00169000|"     The combination of capecitabine and docetaxel is given to treat several different types of     cancer. Capecitabine is usually given by mouth for 14 days, and docetaxel is given IV on the     first day of capecitabine. The effects of changes in the schedule of the combination of     docetaxel and capecitabine has been examined in human breast cancer cells. A capecitabine     by-product was given orally to breast cancer-bearing animals for 14 consecutive days.     Docetaxel was given IV at a variety of times between days 1 and 15. The greatest reductions     in the volume of the cancer were seen when animals were treated with docetaxel between days 6     and 10. In two other breast cancer models, the maximal degree of delay in growth of the     tumors was achieved when the animals were treated with docetaxel on day 8 of a 14 day course     of capecitabine. The extent of tumor response was not explained by changes in tumor levels of     the enzyme thymidine phosphorylase, which is thought to be the mechanism behind the     interaction of capecitabine and docetaxel. In the breast cancer cells, capecitabine increases     the level of proteins which promote death of cancer cells, and it inhibits the levels of     proteins which block death of cancer cells.      Our hypothesis is that capecitabine and docetaxel interact with each other, because     capecitabine primes the pro-death machinery of the cell by increasing the ratio of     death-promoting proteins to death-inhibiting proteins. Cells are more susceptible to killing     by docetaxel when the pro-death machinery is activated by capecitabine.      This is a safety study to find the highest dose of capecitabine that can be given safely for     14 days, in combination with docetaxel given at a fixed dose on day 8. Once this dose of     capecitabine has been determined, an additional nine patients with tumors that can be     biopsied will be treated at this dose, and levels of capecitabine, its byproducts, and     docetaxel will be measured in the bloodstream. Biopsies of tumors will also be taken before     and after the docetaxel is given, and the levels of pro-death and anti-death proteins will be     measured.   "
177734|NCT00169013|"     To investigate whether gabapentin can prevent phantom and stump pain after amputation.   "
177735|NCT00169026|"     The purpose of this study is to examine the short – term effects of clozapine on alcohol use     in persons with schizophrenia and an alcohol use disorder. The hypothesis is that clozapine     will have greater efficacy in reducing alcohol use than other antipsychotic medications.   "
177736|NCT00169039|"     This study will examine the physical response to clozapine or chlorpromazine in people with     schizophrenia that has not improved with treatment.   "
177737|NCT00169052|"     This study will evaluate the effectiveness of a health management and supported     rehabilitation intervention in treating serious mental illnesses in older people.   "
177738|NCT00169065|"     This study will determine the effectiveness of clozapine versus olanzapine in treating people     with schizophrenia that has not improved with treatment.   "
177875|NCT00163111|"     This is a study to investigate the safety and efficacy of voriconazole for the treatment of     candidemia in critically ill non-neutropenic patients   "
177739|NCT00169078|"     Attempts to understand the relationship malaria transmission intensity and antimalarial drug     resistance had rested mainly on mathematical models. To date, except for two studies which     reported reductions in the prevalence of drug resistance in Tanzania and Zimbabwe, no other     field data addressed the impact of reducing malaria transmission by the use of vector control     measures on antimalarial drug resistance. Thus whether vector control decrease or increase     drug resistance remains a contentious issue. The aim of this study was to investigate the     impact of insecticide-treated curtains (ITCs) on clinical and parasitological outcomes in     children with uncomplicated malaria treated with chloroquine (CQ), on the prevalence of     genetic markers of resistance to CQ and sulphadoxine-pyrimethamine (SP) and on the ability of     children to clear drug resistant parasites. The therapeutic efficacy of CQ was studied in 9     villages which used ITCs for 6-8 years and 9 villages with no history of ITC use. A     cross-sectional survey was also conducted to estimate the prevalence of genetic markers of     resistance to CQ and SP in asymptomatic children.   "
177740|NCT00169091|"     This study will examine the physical responses brought on by clozapine and haloperidol in     people experiencing their first episode of schizophrenia.   "
177741|NCT00169104|"     Trastuzumab or Herceptin is an antibody directed against Her-2. Her-2 is a growth factor     receptor which is present on the tumors of 25% of patients with breast cancer. The addition     of trastuzumab to chemotherapy has been shown in a randomized clinical trial to increase the     response rate to chemotherapy, the duration of response to chemotherapy, and to improve the     duration of survival of patients with metastatic breast cancer. The anticancer mechanism of     action of trastuzumab is unknown, but it is possible that trastuzumab acts by promoting     antibody-dependent cell mediated cytotoxicity (ADCC), or direct killing of cancer cells by     immune cells, triggered by antibodies bound to the surface of the cancer cell. G-CSF is a     drug which is a growth factor for certain types of immune cells. G-CSF has two favorable     effects on ADCC. G-CSF increases the pool of circulating cancer-killing immune cells, and     G-CSF increases the strength of binding of cancer-killing immune cells to a specific part of     the antibody. Therefore, priming with G-CSF significantly increases the efficiency of ADCC,     and four days of treatment with G-CSF has been shown to optimize ADCC in some studies. Recent     data from the investigators' laboratory indicates that chemotherapy can augment ADCC directed     against tumor cells.      The investigators' hypothesis is that pre-treatment with the drug G-CSF would increase the     effectiveness of chemotherapy given with trastuzumab.   "
177742|NCT00169117|"     Although the use of mosquito nets has increased in Africa, many of the nets used are in a     poor state, and not an effective barrier against mosquitoes. This pilot study examines     whether subsistence farmers in rural Africa can be encouraged to repair their mosquito nets     and use their bednets appropriately. Attitudes and practises on sewing and net use were     examined in The Gambia and an intervention developed to promote net repair. Songs and posters     were used to emphasise the importance of repairing nets and their correct use, and served as     aural and visual reminders to repair nets now rather than postpone this household chore. The     intervention was aimed at effectively and cheaply turning a poor net into a good one.   "
177743|NCT00169130|"     The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in     case of bcl-2 overexpression in non previously treated patients aged 60 years or less with     low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal     is to obtain a 15% increase of event-free survival at 2 years.   "
177744|NCT00169143|"     Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3     of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell     lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international     prognostic index (Aa-IPI).   "
177745|NCT00169156|"     To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and     rituximab in patients aged 60 to 80 years with previously untreated AIL.   "
177746|NCT00169169|"     Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with     autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.   "
177747|NCT00169182|"     The purpose of the study is to compare two regimen of chemotherapy used as first treatment     for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy.     The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study     is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the     chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the     induction treatment are treated with radiation with a purpose of larynx preservation. Non     responders patients will be treated with total laryngectomy.   "
177748|NCT00169195|"     The Purpose of this study is to evaluate the efficacy and the safety of R-GEMOX in     refractory/relapsed patients with CD20-positive large B-cell lymphoma who are not eligible     for autologous transplantation.   "
177749|NCT00169208|"     This study is a multicentric trial evaluating the efficacy of the RFM regimen in patients     aged 18 to 75 years with relapsed/refractory follicular NHL.   "
177750|NCT00169221|"     This trial will be an open multicentric randomized phase II study comparing post-operative     radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract     carcinomas.   "
177751|NCT00169234|"     The purpose of this study is to give seniors different doses of a new pneumococcal vaccine     called PCV7 to evaluate the safety of the vaccine and compare the immune response to find out     which amount gives the best immune response. The PCV7 vaccine is currently licensed by the     FDA for use in infants and toddlers only.   "
177752|NCT00169247|"     Larynx preservation remains a very challenging approach in patients with larynx/pharynx     cancer. A first attempt consisted of induction chemotherapy followed in good responders by     irradiation. This approach allowed to preserve 60 % of the larynx without any significant     difference in survival. The second attempt consisted of concurrent chemo-irradiation. This     approach provided a higher larynx preservation rate but survival remained unchanged and     mucosal toxicity was also higher. A third approach is currently under evaluation: induction     chemotherapy followed by concurrent chemo-irradiation in good responders.   "
177753|NCT00169260|"     The goal of this study is to understand how information about smokers' health risks affects     their attitudes, mood, and behavior.   "
177754|NCT00169273|"     We propose to:        -  Conduct cross-sectional assessments of depression, disability, health-related quality of          life, eating patterns, and eating attitudes in a population-based sample approximately          6000 women aged 40-60 with over-sampling of women with BMI greater than 30 kg/m2.        -  Among obese women free of depression, enroll approximately 100 in a 6-month standard          behavior therapy weight management program.        -  Among obese women with significant depression, randomly assign 200 to either a 6-month          standard behavior therapy weight management program or a combined cognitive-behavior          therapy program focused on both depression and weight management.        -  Complete follow up assessments of weight, depressive symptoms, and functional status in          all three treatment groups for 12 months following enrollment      Screening and follow-up data will be used to address the following questions:        -  Association between depression and obesity among middle-aged women        -  Specific effects of depression and obesity on functional status, disability, and health          services utilization        -  Impact of depression on participation in and outcomes of a standardized weight          management program        -  Benefit of combined treatment (focused on depression and weight management) above that          of standardized behavioral therapy for obese women with significant depressive symptoms.   "
177755|NCT00169286|"     This study aims to adapt and pilot test two core elements of an organized care program     (systematic telephone outreach and monitoring to improve quality and continuity of     pharmacotherapy, and structured psychoeducational group programs focused on patient     activation and self-management) in a population-based sample of patients with chronic or     recurrent depression.   "
177756|NCT00169299|"     Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms     including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the     medical community for these symptoms is hormone replacement therapy, which is estrogen and     sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is     known about how well these products work, or their safety. Few have undergone the kind of     rigorous testing required of prescription drugs and little is known about their long-term     effectiveness in relieving symptoms.      The purpose of this study is to compare several over-the-counter herbal remedies to hormone     replacement therapy. Our primary aim is to look at the effects of these remedies on your     self-reported menopausal symptoms. We will also be measuring their effects on other factors     known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density,     vaginal cell structure, and blood clotting.   "
177757|NCT00169312|"     RATIONALE: Websites for nutrition education may be an effective method to help people eat     more fruits and vegetables which may lower their risk of cancer.      PURPOSE: This randomized trial is studying how well an internet-based nutrition education     program works in preventing cancer in participants of health maintenance organizations.   "
177758|NCT00169325|"     Basal ganglia are involved in the control of motor, cognitive and emotional behaviours. The     aim of this study is to precisely evaluate patients with basal ganglia focal lesions both     with or without loss of psychic-self activation.   "
177759|NCT00169338|"     Bilateral pallidal stimulation is effective in the treatment of patients with generalised     idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal     stimulation in patients with post-anoxic generalised dystonia or non-generalised primary     dystonia.   "
177760|NCT00169351|"     Tourette syndrome is rare. In France, about 3000 patients have a severe form of the disease.     The aim of this study is to collect clinical characteristics in 200 patients with Tourette     syndrome.   "
177761|NCT00169364|"     Parkinson's disease is a frequent neurodegenerative disorder. Genetic forms of the disease     have been recently identified. The monogenic form due to parkin mutation is responsible for     many familial cases and sporadic forms. However, the relationship between the mutation and     the genotype of patients is not fully established. The aim of this study is to compare     clinical, metabolic and neuropsychological characteristics obtained in patients with parkin     mutation with those of patients without parkin mutation.   "
177762|NCT00169377|"     Obsessive-compulsive disorder is a disabling and frequent disorder. In some patients, the     medical treatment is ineffective. The pathophysiology of this disease is still unknown. Some     data suggest that basal ganglia dysfunction could participate in the occurrence of OCD. The     aim of this study is to evaluate the efficacy of subthalamic nucleus high-frequency     stimulation in patients with severe OCD.   "
177763|NCT00169390|"     Smoking substantially inhibits the activities of both monamine oxidase (MAO) A and B enzymes.      Aims of this study: to compare MAO activities and nicotine and cotinine in peripheral blood     of smoking and nonsmoking pregnant women, in their placenta and in cord blood and relate them     with the behavior of their newborns being observed during 48 hours after birth.   "
177764|NCT00169403|"     Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim     of this study is to:        1. evaluate the efficacy and safety of this treatment in patients with idiopathic          generalised dystonia, 3 years after surgery and        2. assess the recurrence of the motor symptoms after the switch off.   "
177765|NCT00169416|"     This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and     valaciclovir in children with chickenpox following oral administration of valaciclovir, for     the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.   "
177766|NCT00169442|"     To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to     assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.   "
177767|NCT00169455|"     Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring     hospitalization of infants and young children in developed and developing countries and can     be a frequent cause of death in children less than 5 years of age. GSK Biologicals has     developed a vaccine against human rotavirus gastroenteritis. In this study, the     immunogenicity, reactogenicity and safety of the HRV vaccine will be evaluated when stored or     reconstituted in circumstances different from the recommendations: i.e. when not     reconstituted with a buffer or when stored for 7 days at 37°C before reconstitution. In     addition, the effect of feeding will be explored for HRV vaccine reconstituted without     buffer.   "
178070|NCT00175877|"     An open ended study in which patients who completed the double-blind study CDP870-027     [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of     Rheumatoid Arthritis (RA).   "
177769|NCT00169481|"     Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered     concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time     of first vaccination.   "
177770|NCT00169494|"     Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and     genitals in men and women. Several types of HPV infection are transmitted by sexual activity     and, in women, can infect the cervix (part of the uterus or womb). This infection often goes     away by itself, but if it does not go away (this is called persistent infection), it can lead     in women over a long period of time to cancer of the cervix. If a woman is not infected by     HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the     consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing     processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in     young adolescents and women of 10-25 years of age at study start. Approximately 750 study     subjects will receive different lots of the HPV vaccine administered intramuscularly     according to a 0-1-6 month schedule.   "
177771|NCT00169507|"     Evaluate the immunological memory induced by 4 doses of GSK Biologicals' 11valent     pneumococcal vaccine; study antibody persistence 30 months after the 4 dose vaccination with     GSK Biologicals' 11-valent pneumococcal vaccine in Undeca-Pn-010 study.   "
177772|NCT00169520|"     The purpose of this study is to determine the dose regimen of SB-715992 in combination with     docetaxel in patients with solid tumors. SB-715992 and docetaxel were dosed by 1-hour     intravenous infusion every 3 weeks (on the same day). A patient may continue to receive     treatment as long as they are benefiting from the treatment. Blood samples will be taken at     specific times to measure the amount of both drugs in your body at specific times after the     drug is given. Blood samples will also be taken for lab tests such as complete blood counts     and clinical chemistries. Physical exams will be performed before each treatment with     SB-715992. During the treatment phase, the patients will undergo regular assessments for     safety and clinical response.   "
177773|NCT00169533|"     The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to     provide lapatinib to patients who had a positive response in previous lapatinib studies until     lapatinib is available pending FDA approval.   "
177774|NCT00169546|"     Comparison of two asthma treatments by lung function measures.   "
177775|NCT00169559|"     An eight week comparison of the investigational drug GW590735, placebo, and the marketed drug     fenofibrate intended to increase the levels of good cholesterol and decrease levels of bad     cholesterol in healthy patients with low levels of good cholesterol and high levels of bad     cholesterol.   "
177776|NCT00169572|"     This study was designed to assess the safety and efficacy of an investigational agent     administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy     induced nausea and vomiting.   "
177777|NCT00169585|"     Multicentric, national, prospective, parallel group, controlled. The Subjects in every center     will be randomized and assigned to the pharmacologic arm or the one with the biochemical     monitoring   "
177778|NCT00169598|"     This randomised study aimed at evaluating the medical and economical impact of positron     emission tomography (PET) using fluorine-18-fluoro-deoxyglucose (FDG) in the therapeutic     prescription in patients with Hodgkin’s lymphoma or with large B and P cell non-Hodgkin’s     lymphoma. The median progression free survival, the costs and the quality of life are     compared between two groups : Group 1: the results of conventional staging and of the PET are     known before stem cell transplantation. Group 2: only the results of conventional staging     before stem cell transplantation are known before stem cell transplantation.   "
177779|NCT00169611|"     Neurofibromatosis type 1 (NF1) is an autosomal dominant disorder with an estimated prevalence     of 1/2190 to 1/6711. Attention deficit hyperactivity disorder (ADHD) has been reported to be     common in NF1. We, the researchers at Hospices Civils de Lyon, designed a randomized, double     blind, placebo controlled, crossover trial with a total follow-up duration of 9 weeks to     evaluate the effect of methylphenidate (MPH) on the improvement on the simplified parents     Conners' Rating Scale. In a parallel exploratory study we will compare the nature of     attention deficit disorders in NF1 children to 30 ADHD NF1-free controls. Children aged 7 to     12 years are eligible when their intelligence quotient (IQ) is between 80 and 120. Fifty     subjects (25 for each period) were required for testing the primary study hypothesis.   "
177780|NCT00169624|"     Peripheral and coronary endothelial dysfunction in type 2 diabetic patients may be influenced     by therapeutics. Using Radial flow monitoring and myocardial perfusion magnetic resonance     imaging, we designed a controlled randomized double blind study to test the hypothesis that     endothelial dysfunction will be reversed following 3 months of Metformin administration vs     gliclazide. 30 patients will be included.   "
177781|NCT00169637|"     This is a randomized controlled, parallel group, open label versus no treatment trial which     evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short     bowel syndrome.The total follow-up is 14 months; 4 months for each group after randomization;     At the end of the first four months: the treated group will be followed within 6 months, the     untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months     after the end of the treatment period.   "
177782|NCT00169650|"     The gold standard for the treatment of ureteropelvic junction obstruction (UPJO) is the open     pyeloplasty. As a minimally invasive alternative, many centers are currently offering     laparoscopic pyeloplasty (LP) as primary therapy for UPJOs. Recent data has shown that     laparoscopic pyeloplasty has comparable success rates to open pyeloplasties and produces     durable results. The researchers are compiling a registry and database to review outcomes of     laparoscopic pyeloplasty patients.   "
177783|NCT00169663|"     Brushite kidney stones are a unique form of calcium phosphate stones that have a tendency to     recur quickly if patients are not aggressively treated with stone prevention measures. Little     research has been undertaken to better understand the clinical history and potential urinary     abnormalities that may predispose one to these troublesome kidney stones.   "
177966|NCT00174512|"     To assess the effects of GTN on QT and QTc in subjects with And without atrial pacing. This     will be done with and without autonomic blockade at two different pacing rates. Moxifloxacin     effect on QT and QTc will also be assessed in atrially paced patients at two different pacing     rates with and without autonomic blockade   "
177784|NCT00169676|"     Recently, many centers have begun offering laparoscopic radical prostatectomy (LRP) as a     minimally invasive therapy for localized prostate cancer.1-6 LRP may offer the advantages of     improved neurovascular bundle sparing, a more precise urethrovesical anastomosis, shorter     hospitalization, and decreased convalescence.      Our group at Methodist Urology, LLC has extensive experience in laparoscopy and in treating     prostate cancer and are planning to offer LRP. We intend to maintain a registry and database     to document the outcomes with LRP.   "
177785|NCT00169689|"     The study is a prospective, randomized, double-blind sham-controlled study.   "
177786|NCT00169702|"     The study is a prospective, randomized, open-label study.   "
177787|NCT00169715|"     Historically, percutaneous treatment of stone-bearing caliceal diverticula has resulted in     the best success rates when examining factors such as symptom relief and stone-free rates     (Jones, et al, 1991). Many groups have reported modifications in their percutaneous approach     which have reportedly improved patient outcomes, but these series have very limited     populations. Another issue concerning stone-bearing caliceal diverticula centers on the     etiology of stones formation within these areas. This topic remains a subject of debate, with     conflicting data in the literature.   "
177788|NCT00169728|"     The purpose of this study is to determine the immunogenicity and tolerability of the     DTaP-IPV-HBV/Hib combination vaccine Infanrix hexa and the heptavalent pneumococcal conjugate     vaccine Prevenar in pediatric recipients of allogeneic haematopoietic stem cell     transplantation.   "
177789|NCT00169741|"     Patients with large or otherwise complex renal calculi are commonly treated by percutaneous     nephrolithotomy (PNL; PERC). PERC requires the creation of an approximately 10 mm channel     through the renal parenchyma, into the intra-renal collecting system, in order to effect     stone fragmentation and extraction. Although the nephrostomy tract is confined to a small     fraction of the renal parenchyma (approximately 1%), the trauma associated with the creation     of the tract will affect blood flow and oxygen delivery to regions beyond the immediate site     of injury. It is possible that this could result in a significant functional renal     impairment. There are several reports describing the effect of PERC on renal function, but     interpretation of these studies is difficult, due to a lack of uniformity in patient     selection and variability in the timing of peri-operative evaluation. Recent data from the     investigators' lab, obtained from a porcine model, suggest that, acutely, PERC causes a     significant decrease in renal function as measured by para amino hippurate (PAH) clearance.     The purpose of this study is to determine, in a rigorous and standardized fashion, the acute     effects of PERC on renal function, as measured by nuclear renography.   "
177790|NCT00169754|"     Urolithiasis is a common condition in the United States, and is associated with significant     morbidity and even mortality. The most commonly occurring urinary calculi are comprised of     calcium oxalate salts, and until recently, the pathogenesis of calcium oxalate calculi was     poorly understood. New evidence, however, suggests that the development of calcium oxalate     calculi may be intimately associated with hydroxyapatite (HA) plaque, also known as Randall's     plaque, which is located on the renal papillae. The investigators have previously     demonstrated that Randall's plaque originates in the thin ascending limb of the loop of     Henle, and they have shown that Randall's plaque is composed of HA (Evan, Lingeman et al.     2003). As well, the amount of Randall's plaque correlates with elevated levels of urinary     calcium and decreased urinary volume, risk factors for the formation of calcium oxalate     calculi (Kuo, Lingeman et al. 2003). In the course of these previous studies, the     investigators have anecdotally noted that calcium oxalate stones are often found attached to     Randall's plaque, an observation that others have reported as well (Prien 1949; Carr 1954;     Cifuentes Delatte, Minon-Cifuentes et al. 1987). However, there has been no in-vivo, rigorous     documentation of this attached stone relationship. Attached calculi represent an important     point in the pathogenesis of calcium oxalate calculi, as they correspond to a moment in time     where there is a continuum between the HA plaque of Randall and the calcium oxalate stone,     thus linking the origin of plaque with the development of stone. A better understanding of     the phenomenon of attached calculi will lead to a better understanding of how and why calcium     oxalate stones form, which may ultimately direct future interventions to attenuate stone     activity.   "
177791|NCT00169767|"     Many options currently exist to relieve the symptoms caused by benign prostatic hyperplasia     (BPH). At present, transurethral resection of the prostate (TURP) serves as the surgical     standard to which all other operative treatments are compared. Although TURP provides     excellent short and long-term results, this procedure has many potential risks and     complications. The desire to avoid the potential risks of TURP and still achieve results of     comparable durability has led to the development of alternative surgical procedures.      One such surgical alternative in the treatment of BPH is holmium laser ablation of the     prostate (HoLAP). HoLAP has been compared to TURP in a randomized clinical trial with     comparable outcomes in both uroflow rate and symptom score improvements (Mottet, et al 1999).     Use of the holmium laser in treating BPH provides specific advantages over TURP. The risk of     dilutional hyponatremia is eliminated, as the holmium laser can be used in conjunction with a     normal saline irrigant. In addition, the hemostatic properties of the holmium laser results     in superior hemostasis, thus minimizing the risk of bleeding. HoLAP has been utilized for     prostate glands up to 60 grams in volume, as larger glands become more inefficient to treat     using a tissue vaporization technique.      Recently, another laser technology has been introduced for the surgical treatment of BPH, the     potassium titanyl-phosphate (KTP) laser. This modality can also be used to vaporize     obstructive prostate tissue, and has been studied through single arm clinical studies.     Short-term results are promising, with significant improvements in voiding symptoms and urine     flow rates as well as minimal associated morbidity. However, to date a randomized comparison     study between HoLAP and KTP laser vaporization of the prostate has not been reported. A group     of investigators with extensive experience with both procedures intends to objectively     compare these two procedures in a randomized clinical trial.   "
177792|NCT00169780|"     Current practices of the diagnosis of urinary stones gives little information on the probable     fragility of stones using shock wave lithotripsy (SWL), and many patients receive more SW's     than is necessary to break up their stones. Indeed, some patients are treated with SWL when     their stones cannot be fragmented using this technology. The investigators have ample     evidence that computed tomography (CT) images of kidney stones can reveal significant     internal structure in stones—structure that is likely to be useful in predicting stone     fragility—but no one has explored the use of clinical helical CT for this purpose. Also, the     investigators do not know the effect that the human body wall and kidney tissue will have on     the resolution of kidney stone structure with helical CT.   "
177876|NCT00163124|"     There are a variety of treatment approaches used by the chiropractic profession. Some of     these require forceful joint manipulation and some do not. This study is designed to compare     outcomes of two such techniques that are common to chiropractic practice. The hypothesis is     that there is no difference between forceful and non-forceful approaches to treatment.   "
177793|NCT00169793|"     Test the hypothesis that the new bariatric surgical procedures (BSP) increase stone risk, and     will result in an increased incidence and prevalence of stone disease; the purpose is to     determine if BSP patients require special management for stone prevention. This study does     not include the bariatric surgery but enrolls subjects who are already scheduled for surgery     with an affiliated surgeon. The study procedure is to collect 24 hour urines pre-and post     surgically to evaluate the risk of kidney stone procedure after surgery.   "
177794|NCT00169806|"     Kidney stones are very common. They affect 3-5% of the population in the United States. Many     people are hospitalized for the treatment of kidney stones and some may die. Better     understanding of what causes kidney stones is useful in both the treatment and prevention of     kidney stones. However, exactly what causes kidney stones is unknown.      The most common type of kidney stones contains calcium, which sometimes is attached to a part     of the kidney important in producing the final urine, called the papilla. The investigators     have noticed that persons who form kidney stones seem to have more papilla with stones     attached. They propose to study these areas of the papilla, called Randall's plaques (named     after their discoverer), in patients undergoing surgery for kidney stones.   "
177795|NCT00169819|"     HYPOTHESES        -  Discharge on the same day after uncomplicated trans-radial coronary artery stenting is          safe and effective.        -  Hospitalized patients can be safely returned to the referring center the same day          following trans-radial coronary artery stenting.        -  Abciximab given as a single bolus with optimal trans-radial coronary artery stenting is          as safe and effective as bolus + 12 hrs perfusion and does not hamper early discharge.        -  Same-day discharge is cost-effective and increases patient satisfaction.      OBJECTIVES AND END-POINTS      The objectives of the present study are to assess the effectiveness and safety of same day     hospital discharge after uncomplicated coronary artery stenting when a single bolus of     Abciximab is used. The primary end-point of the study is the composite of death, myocardial     infarction, repeat hospitalization, urgent revascularization, severe thrombocytopenia, access     site complications and major bleedings at 30 days following stent implantation.      The secondary end-point is the composite of death, myocardial infarction, repeat target     vessel revascularization at 30 days, 6 months and 1 year following stent implantation. Other     secondary end-points include the total hospital stay (days) between the index procedure and     the first 30 days follow-up, the number of unsolicited medical visits in relation with the     percutaneous procedure, index of patient satisfaction and direct and indirect costs.   "
177796|NCT00169832|"     HYPOTHESES        -  Rosiglitazone in diabetic patients with previous coronary bypass surgery may prevent or          slow the progression of atherosclerosis in SVGs and native coronary arteries.        -  Rosiglitazone has favorable effects on adipose tissue distribution variables as well as          on thrombosis, pro-inflammatory, and lipid profiles in diabetic patients after coronary          bypass artery surgery.        -  Rosiglitazone therapy influences favorably metabolism and clinical outcomes in diabetic          patients after coronary artery bypass surgery.      OBJECTIVES        -  PRIMARY To assess the efficacy of rosiglitazone to reduce atherosclerosis progression in          vein grafts in diabetic patients after coronary bypass surgery by using IVUS imaging          after a 12 mo follow-up.        -  SECONDARY             -  To prospectively compare the secondary IVUS endpoints.             -  To prospectively compare the angiographic endpoints.             -  To prospectively compare the metabolic risk factor endpoints.             -  To prospectively compare the body composition and distribution endpoints.             -  To prospectively compare the clinical outcomes of rosiglitazone versus standard               care using composite endpoints.   "
177797|NCT00169845|"     Epidemiologic studies suggest that low dietary intakes and low plasma concentrations of     antioxidant vitamins and minerals are associated with increased risks of cancer, especially     for epidermoid tumors. Patients with stage I or II head and neck cancer have a good     prognosis, with a 5-year relative survival of 60% to 90%, depending of the tumor site.     However, the benefit of treatment is often compromised by the occurrence of second primary     cancers, which develop in 20% of patients during the first 5 years after diagnosis. We     conducted a randomized chemoprevention trial among patients with head and neck cancer treated     by radiation therapy to determine whether supplementation combining two antioxidants,     alpha-tocopherol and beta-carotene, could reduce the incidence of second primary cancers in     this patient population (primary objective of the trial). This study was conducted with funds     from the NCIC (#008176,004738,013211) and was completed.      In this cohort of head and neck cancer patients, we evaluated whether nine potential     prognostic serum markers measured at the time of diagnosis were related to recurrence,     occurence of second primary cancers and survival. This study was conducted with funds from     the NCIC (#018100) and was completed.      Presently, we evaluate genetic polymorphisms(GWAS) associated with prognosis (NCIC grant     #019502). We also assess the relationship between vitamin D (dietary intake, serum level, and     genetic polymorphisms of key vitamin D-related genes) and head and neck long-term outcomes     (NCI grant #1R03CA141615-01).   "
177798|NCT00169858|"     Hepatitis B immunization has been offered to all grade 4 students (age 9-10) in the province     of Quebec, using Engerix-B at a dose of 10 mkg. The peak incidence of hepatitis B occurs     between age 15 and 35; the proportion of vaccinated children who will still be protected at     this age is currently unknown. This study is designed to determine:        -  persistence of immunity until age 25        -  persistence of immunological memory as demonstrated by an anamnestic response following          a booster dose        -  the effect of a booster dose on immunogenicity at either 5, 10 or 15 years after the          primary vaccination course (at age (15, 20 or 25).   "
177799|NCT00169871|"     The objective of this proposal is to study the applicability of the hs-CRP assay in the     assessment of CV risk in daily clinical conditions where hyperlipidemic population with or     without CHD are currently evaluated.   "
177800|NCT00169884|"     The purpose of this study is to evaluate whether the proposed cognitive-behavioural     intervention is effective for DSH patients in the age group 15-35 years. In addition, we will     examine which elements derived from the theoretical model can explain the efficacy of the     intervention.   "
177877|NCT00163137|"     To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60     mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.   "
177878|NCT00163150|"     The main purpose of this study is to evaluate the efficacy of atorvastatin treatment during 3     months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients.   "
177801|NCT00169897|"     Short term efficacy of pulmonary rehabilitation for improving functional capacity and quality     of life of chronic obstructive respiratory disease (COPD) patient is well known. However,     there is an important gap between the scientific knowledge and the clinical use of pulmonary     rehabilitation since a a very small number of patients benefit from this therapeutic     intervention. We estimate that less than 1% of the 750 000 canadians suffering from COPD have     access to a pulmonary rehabilitation program. We want to study the efficacy of a home-based     rehabilitation program as a way to facilitate the access to rehabilitation.   "
177802|NCT00169910|"     This is a prospective randomized study to compare the influence of area under the curve     (AUC)-monitored dual treatment with steroids in combination with either a calcineurin     inhibitor (CNI) or mycophenolate mofetil (MMF) on the progression of subclinical     cardiovascular disease in renal transplant recipients.      Since CNI have a detrimental effect on cardiovascular risk factors, it is the researchers'     hypothesis that renal recipients after CNI withdrawal will have more reduction of markers of     cardiovascular disease.   "
177803|NCT00169923|"     The purpose of this study in patients with stage 4 and 5 chronic kidney disease is to     determine whether rosiglitazone can reduce inflammatory markers and to investigate its effect     on intima media thickness, calcification and pulse wave velocity.   "
177804|NCT00169936|"     Heart transplantation is a great procedure for selected patients with end-stage heart     failure, but graft rejection remains a major factor limiting long-term survival despite     continued advancement in the scientific skill of immunosuppression. The only reliable method     used today to detect rejection is doing repeated biopsy of the heart. This is expensive,     invasive, inconvenient to the patient, and associated with a significant risk of serious     complications, as a piece directly from the inner surface of the patients heart is needed.     The magnetocardiograph (MCG) device is an invention that may provide new means to assess     changes in the heart tissue, as it may detect small changes that happen in the heart cells     when they are undergoing rejection.   "
177805|NCT00169949|"     The RAP Program is conducting a research study of the antipsychotic medication Aripiprazole.     This drug has been approved for treating symptoms associated with schizophrenia and is     associated with fewer side effects. This study will explore how well Aripiprazole treats     symptoms of early-onset psychotic disorders as well as symptoms that may indicate risk for     such disorders, including unusual thoughts, suspiciousness, perceptual abnormalities, social     isolation, and sudden changes in functioning.   "
177806|NCT00169962|"     Even with current standard ED treatments 20-25% of patients presenting to the ED with an     acute asthma episode will still require hospitalization. For patients unresponsive to     beta-agonists the admit rates will be higher. Of those well enough to be discharged from the     ED nearly 30% will relapse within one month. More than 5,000 patients with asthma still die     each year in the USA. For patients who do not respond to beta-agonists, there are relatively     few treatment options for rapid improvement of symptoms and pulmonary function. Presumably,     mucous secretion and plugging play an important role in the pathogenesis of severe asthma     unresponsive to beta-agonists. The use of agents to promote clearance of intra-luminal     secretions and mucous plugs may represent an important advance in the management of acutely     ill asthmatics, both to hasten recovery and prevent deterioration in the acute care setting     and to prevent relapse after discharge from the ED.      OBJECTIVES      2.1 Study Hypothesis: rhDNAse can be safely used in patients presenting to the Emergency     Department with acute moderate-severe asthma who do not have adequate responses to     beta-agonists      Project Specific Aim: This is a pilot study to determine the safety of three different doses     of pulmozyme® (2.5mg, 5.0mg and 7.5mg) in patients presenting to the ED with acute asthma. In     addition to safety trends for improvement in pulmonary function and clinical outcomes will be     monitored and data analyzed. Based on the safety profile and observable responses to     treatment, this information may be used to develop larger trials to determine the efficacy     and dosing strategy for treating acutely ill asthmatics with rhDNAse.   "
177807|NCT00169975|"     A magnetocardiograph (MCG) is a device capable of recording of magnetic fields arising from     the electrical activity of the heart with traces similar to an electrocardiogram (ECG). This     system was developed as a noninvasive, non-contact diagnostics of obstructive coronary artery     disease (CAD), and especially of lack of oxygen in the heart as in a heart attack. The     overall objective of this study is to demonstrate the efficacy of this MCG device for the     detection and diagnosis of lack of oxygen of the heart in patients with chest pain.   "
177808|NCT00169988|"     The Recognition and Prevention (RAP) Program is conducting a research study comparing an     antidepressant, sertraline, alone versus in combination with a second-generation     antipsychotic, risperidone, to evaluate their ability to reduce unusual thoughts,     suspiciousness and other unusual experiences, to improve reasoning ability, memory, attention     and social skills in adolescents.   "
177809|NCT00170001|"     The investigators hypothesize that persons with the particular cluster of symptoms that are     due to supraesophageal reflux (SER) will have complete resolution of those symptoms with     adequate acid suppression when a PPI is administered for 6 months.   "
177810|NCT00170014|"     magnetocardiography has been extensively studied focusing on the possible clinical     applications of the device. Evaluating the precision of a device is a prerequisite condition     to know what are significant changes and how can these be trusted. A respectable     reproducibility study for the MCG measurements is crucial for this new device to be used for     clinical applications. In this study, we will focus on a critical portion of the heart cycle     assessing for changes in time of the computerized analysis of this phase and comparing the     analysis done by two examiners.   "
177811|NCT00170027|"     A magnetocardiograph (MCG) is a medical device capable of recording the magnetic fields that     arise from the electrical activity of the heart. It was developed for the general purpose as     a noninvasive, non-contact diagnostic tool of obstructive coronary artery disease (CAD), and     especially of cardiac ischemia. The overall objective of the present study is to demonstrate     the efficacy of this MCG device in the diagnosis of lack of oxygen to an area of the heart     (as in an Heart attack) in patients presenting with chest pain.   "
177879|NCT00163163|"     To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid     intima-media thickness in postmenopausal women with moderate hypercholesterolemia.   "
177812|NCT00170053|"     Kidney transplant patients will be treated with Thymoglobulin (5 days), tacrolimus (Prograf),     and mycophenolate mofetil (Cellcept) from the time of transplant. They will only receive     steroids for 4 days and no prednisone after that. At 1 month, they will have a kidney biopsy     and if it is ok, patients will be treated long term with either continued     tacrolimus/mycophenolate mofetil or be switched to sirolimus (Rapamune)/mycophenolate     mofetil. This will be done randomly in a manner similar to flipping a coin. The investigators     are trying to determine if after the initial therapy patients can stay off steroids long term     and get better kidney function if they are treated with sirolimus compared to tacrolimus.     Patients will be followed for 3 years and will repeat kidney biopsies at 1 and 2 years after     transplant.   "
177813|NCT00170079|"     Smoking is the number one preventable cause of morbidity and mortality in this nation.     Unfortunately, more than 50% of those who quit following a smoking cessation intervention     typically relapse within two weeks, with approximately 80% relapsing within six months.     Therefore, tobacco use can be conceptualized as a chronic condition. As with many chronic     medical problems, tobacco use interventions may benefit from a step care approach to     treatment.      A total of 400 adult smokers will be enrolled in the study. Participants will be randomly     assigned to one of two treatment conditions consisting of: 1) A State of the Art Smoking     Cessation Intervention + Recycling or: 2) A State of the Art Smoking Cessation Intervention +     Step Care. Long term smoking cessation will be assessed by self-report, exhaled carbon     monoxide levels, and salivary cotinine. The primary endpoint of the study will be smoking     abstinence rates at two-year follow-up. It is predicted that long-term cessation rates will     be significantly higher in the step care condition than for those assigned to the recycling     group.   "
177814|NCT00170105|"     Study Objective:        -  To examine the perceptions of time spent at the bedside; perceptions of bedside manner;          and patient perceptions of the provider-patient interaction offered by emergency          providers when they sit versus when they stand during the initial evaluation.      This project is clinically relevant research different from prior Emergency Department (ED)     satisfaction studies since this study will contribute information about factors that could     increase patient satisfaction with his/her provider in the ED setting. This research may     guide specific guidelines for quality improvement efforts. The investigators hypothesize that     patients will perceive that the emergency providers are at the bedside longer, demonstrate     better bedside manner, and have better provider-patient interactions when they sit versus     when they stand. Additionally, the investigators hypothesize that providers who sit will     perceive that they are at the bedside longer than those who stand for the same period of     time.      Methods: A convenience sample of adult patients will complete a 5-item questionnaire     concerning the perceived time spent with the emergency provider and the qualities of the     provider-patient interaction. Emergency providers will be randomly assigned to either sit or     stand during the initial evaluation. The providers will complete a 4-item questionnaire.     These data will be compared to the actual time spent in the evaluation, measured in seconds,     using a stopwatch. These data, combined with demographic data obtained from the patient     chart, will be analyzed to examine whether there are statistically significant differences in     patient perceptions and satisfaction.   "
177815|NCT00170118|"     The majority of the study consists of standard of care treatment for people with low back     pain that has lasted more than three months. Half of the participants in the study will     receive physical therapy from physical therapists that have received additional training in     an educational technique. In order to determine if there is a difference in patient outcome     when the educational technique is used, you will be asked to complete five short surveys     before receiving physical therapy (10 minutes total). A sample of the physical therapy     sessions using the educational technique will be videotaped. The videotape will be of the     physical therapist to prove they did use the educational technique, not of you the     participant in the study. You will remain anonymous and will not be used and the tape will     not be used for publication or presentation purposes. You will also be asked to complete one     survey after participating in physical therapy (2 minutes), and all five short surveys (10     minutes total) six weeks after your last physical therapy session.      You will be put in one of 2 groups by chance (as in the flip of a coin). A computerized     selection process will be used to assign participants to the study. You will not know if you     are in the study group or the non-study group.   "
177816|NCT00170131|"     Samples from a large clinical trial comparing three immunosuppression regimens, two of which     contained MMF, are used to identify the HCV viral quasispecies behaviour after liver     transplantation   "
177817|NCT00170144|"     With aging, there is a decrease in muscle mass and function especially in the energy     storehouses of cells called mitochondria. Amino acids, the building blocks of protein, and     insulin have been shown to increase muscle mitochondrial protein synthesis and thereby     function. Branched chain amino acids which can only be provided in the diet seem to be key in     this process. Therefore in our study, our aim is to study the effect of branched chain amino     acids on muscle mitochondrial protein synthesis in both the young and elderly. By doing so,     we can then elucidate if branched chain amino acid supplementation has future potential in     improving quality of life and performance in the elderly. The study will involve blood     sampling and needle muscle biopsy.   "
177818|NCT00170157|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such     as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of     androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry cancer-killing substances to them. Giving     antihormone therapy together with ipilimumab may kill more tumor cells.      PURPOSE: This randomized phase II trial is study how well giving hormone therapy and     ipilimumab together works in treating patients with advanced prostate cancer.   "
177819|NCT00170170|"     This study will investigate the clinical variables that may be used to predict who among the     solid organ transplant recipients will develop cytomegalovirus (CMV) disease after completing     antiviral prophylaxis.   "
177957|NCT00174395|"     To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the     migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of     migraine.   "
178088|NCT00176111|"     In this study we want to examine the effect of a small amount of local anesthetic or saline     solution on nerve conduction using a peripheral nerve stimulator.   "
177820|NCT00170183|"     Patients hospitalized for treatment of decompensated heart failure (CHF) are at risk for     prolonged length of stay (LOS) and frequent readmissions. Renal dysfunction and diuretic     resistance contribute to this risk, particularly if renal dysfunction worsens during CHF     treatment. Brain natriuretic peptide (BNP) is a hormone of myocardial cell origin with     well-defined physiological effects which include arterial and venous vasodilation,     suppression of adverse neurohumoral systems and favorable effects on renal hemodynamics and     sodium excretion. Recombinant human BNP (Natrecor) is approved by the FDA for treatment of     decompensated CHF as it has been demonstrated to lower filling pressures and improve     symptoms. While clinical trials and the FDA support the use of BNP as adjuvant therapy in     decompensated CHF, the extent of its efficacy in improving non-hemodynamic CHF parameters has     not been fully defined.      The objective of this clinical practice protocol is to determine whether use of BNP in     addition to standard therapy, will preserve renal function and facilitate diuresis in     patients with CHF and mild-moderate renal impairment (creatinine clearance > 20 but < 60     ml/min) as compared to standard therapy alone. Patients admitted to the Mayo Heart Failure     Service who meet entrance criteria will be randomized to standard clinical practice with or     without a 48 hour infusion of BNP.      The primary endpoints will be indices of renal function and diuretic response at 1, 2 and 3     days and at discharge. Secondary endpoints will be neurohumoral function, LOS and 30-day     readmission rate.   "
177821|NCT00170196|"     The purpose of this study is to determine the efficacy of addition of corticosteroid therapy     to antibiotics in patient admitted with Community-acquired pneumonia.      The hypothesis is: Prednisolone in combination with antibiotic treatments is effective in     improving clinical outcome in patients hospitalized with CAP.   "
177822|NCT00170209|"     Tuberculosis (TB) is spread by airborne transmission from adults with active contiguous TB to     children, especially those living in the same household. Once children are exposed and     infected they are at very high risk to develop active TB - which can be lethal if not     detected and treated promptly. This makes it very important to detect TB infection as soon as     possible, and treat this while it is still latent or dormant. Current therapy for latent TB     infection is 9 months of Isoniazid; this is very effective if taken properly but because     treatment is so long many children do not finish this. Four months of Rifampin is a     recommended alternative. In adults this has been shown to be safer with much higher     completion rates. However the effectiveness of this treatment is unclear, and is being     studied in an ongoing study. The investigators plan to compare the safety as well as the     acceptability and effectiveness of 4 months Rifampin with 9 months Isoniazid (standard     treatment) in children in several sites in Canada and other countries.      It is hypothesized that among children at high risk for development of active TB,     intolerance/adverse events will not be worse (non-inferiority), among those randomized to     4RIF compared to those randomized to 9INH. In addition completion of latent tuberculosis     infection (LTBI) therapy will be significantly greater (superiority), and subsequent rates of     active TB will not be significantly higher (non-inferiority) in children taking 4RIF.   "
177823|NCT00170222|"     The role of antibiotic therapy in patients with COPD remains controversial. While the outcome     of several clinical trials is in favour of antibiotics, the quality of these studies in     insufficient. In this study the efficacy of doxycycline is compared to placebo. All     concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.      The investigators hypothesize that patients with an acute exacerbations will have a better     outcome when treated with antibiotics.   "
177824|NCT00170235|"     The overall aim of this pilot study is to explore the feasibility of a randomized trial to     test the effectiveness of physical therapy, provided both pre- and post-surgery, on reducing     arm morbidity and increasing health-related quality of life (HRQL) post-surgery.   "
177825|NCT00170248|"     Asthma is a health problem that afflicts many Canadians. Better methods are needed to provide     primary care physicians with ways of implementing current guidelines into regular practice     for optimal disease management. This study will test the benefits of providing computer-based     decision-support for asthma to primary care physicians, with links to home monitoring for     their patients. To add value and to ensure regular use for the physician for all of his/her     patients, these computerized decision-support tools will be linked to an electronic     prescribing and drug management system. The investigators will evaluate the effectiveness of     the computer-based decision-support system by determining whether asthma patients of     physicians who receive computer-assisted management tools have better disease control after     33 months of implementation compared to asthma patients of physicians who have the electronic     prescription and drug management system alone. To answer this question, the investigators     will conduct a cluster randomized controlled trial in a population of approximately 100     physicians in 40 clinics in Quebec, and a total of approximately 4500 of their patients with     asthma.   "
177826|NCT00170261|"     This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a     primary implantation of a loop recorder versus the conventional diagnostic cascade for     syncope most likely due to cardiac arrhythmia.   "
177827|NCT00170274|"     The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms     of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an     indication for cardiac pacing according to the German guidelines. Medication is controlled     throughout the study with a beta-blocker as the only antiarrhythmic drug.   "
177828|NCT00170287|"     The present standard of care for the management of unstable ventricular tachycardia (VT) in     the setting of chronic coronary artery disease is the placement of an implantable     cardioverter defibrillator (ICD) after the initial episode, and radiofrequency ablation     and/or antiarrhythmic medication in the event of recurrences causing frequent ICD     interventions.      The primary purpose of this randomized study is the assessment of recurrences of unstable VT     in patients who undergo ICD implantation plus substrate ablation after the initial episode     compared to patients who only undergo ICD implantation. Thus the primary purpose is an     improvement in the quality of life. A decrease in mortality is not a primary purpose of this     study.   "
177829|NCT00170300|"     The CARE-HF trial evaluates the effects of Cardiac Resynchronization (CR) therapy on the     mortality and morbidity of patients with heart failure due to left ventricular systolic     dysfunction already receiving diuretics and optimal medical therapy.   "
177830|NCT00170313|"     The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator     (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for     cardiac resynchronization) is equipped with the Conducted-Atrial Fibrillation     (AF)-Response-Algorithm (CAFR). This algorithm is designed to maximize biventricular     stimulation and thus the amount of cardiac resynchronization when atrial fibrillation occurs.     The goal of the study is the evaluation of the effect of the CAFR in CRT-patients suffering     from atrial fibrillation by quantification of the increase of biventricular pacing during     atrial fibrillation caused by CAFR as well as the influence of the CAFR on the ventricular     heart rate.   "
177831|NCT00170326|"     The purpose of this pilot study is to evaluate the progression of ventricular dysfunction in     patients with ventricular dysfunction within the permanent pacing population.   "
177832|NCT00170339|"     This is a pilot study designed to answer the question  Do men who are receiving methadone     maintenance therapy have lower spinal bone densities compared with age-matched controls who     are not receiving methadone therapy?      The primary aim is to assess whether the mean or median spinal dual-ray energy x-ray     absorptiometry (DEXA) scan results are different between these two groups of male patients.     Primary measurements include: spinal bone densitometry by DEXA scan.      The secondary aim is to examine the role of sex steroids in men receiving methadone     maintenance therapy and their association with spinal bone density and sexual dysfunction.     Secondary measurements include: serum testosterone, estradiol, lutenizing hormone, albumin,     sex hormone binding globulin and Vitamin D levels; age; Brief Sexual Function Inventory;     Dietary, smoking/alcohol use and physical activity; Medical history, surgical and medication     use; length of time using illicit opiates and time on methadone maintenance therapy.   "
177833|NCT00170352|"     The purpose of this study is to study the effects of EARLY (no more than 24 four hours from     injury) administration of extra amounts of oxygen on traumatic brain injury.   "
177834|NCT00170365|"     The study examined Restorative Yoga as a method of stress reduction for the HFA Addiction     Medicine Clinic staff volunteers.   "
177835|NCT00170378|"     To study the safety and efficacy of early administration of Low Molecular Weight Heparin to     patients with traumatic brain injury.   "
177836|NCT00170391|"     The principal aim of the study is to evaluate if CBT for insomnia is associated with     improvement in the PSG sleep of patients treated in primary care. Furthermore,the     relationship between subjectively-assessed sleep and PSG sleep are investigated(at     pre-treatment, at post-treatment, in relation to treatment change.   "
177837|NCT00170404|"     The purpose of this study is to see whether people who take vitamins along with the standard     medicine for tuberculosis (TB) recover better and quicker than people who take only the     standard medicine for TB. This study will enroll 600 men and women, who are age 18-65 years,     have TB, and intend to stay in Dar-es-Salaam for at least 2 years from the start of TB     therapy. Half the participants will have active TB and also HIV infection, and the other half     will have TB alone. Half the volunteers will be given vitamins, and the other half will be     given placebo (sugar pill with no vitamins) from the start of their TB therapy, through the 8     months of anti-TB therapy, and up to 48 months. Participation in the study involves visits to     the clinic, physical exams, home visits, and answering questions about personal health, foods     eaten, household, occupation, and education. Volunteers will also provide blood, sputum, and     urine samples.   "
177838|NCT00170417|"     The purpose of this study is to evaluate using an RCT the potential benefits of CBT for     insomnia in the community   "
177839|NCT00170430|"     The purpose of this study is to see if taking medication once a month can help to decrease     the risk of vaginal infections. Additionally, researchers will study whether personal habits,     such as douching, bathing, and sexual practices can influence the risk of vaginal infections.     Vaginal infections may influence the risk of becoming infected with HIV-1 and other sexually     transmitted diseases (STDs). Study participants will include 400 female prostitutes ages 16     and older, living in Mombasa. Study procedures will include sexual behavior questions,     physical examinations including pelvic exams, testing of vaginal and cervical secretions for     STDs, urine collection and blood samples. Participants will receive 2 different types of     pills to treat vaginal infections (metronidazole or fluconazole) or placebo (contains no     medication). Participants will be involved in study related procedures for 1 year and will     return to the study clinic at one month intervals.   "
177840|NCT00162656|"     This is an international trial conducted by three cooperative groups: SFOP (France, Belgium,     Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature     B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and     receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and     C) test whether reduced therapy is equivalent to standard intensive therapy (LMB-89 B and     C) in terms of event free survival. The reason for the modification is to reduce the long     term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In     group B, the modifications of treatment consists of a reduction of cyclophosphamide in     COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a     reduction of the doses in the CYVE courses and the elimination of the last 3 courses of     maintenance treatment   "
177841|NCT00162669|"     Primary liver cancer (hepatocellular carcinoma) is the fifth most common malignant disorder,     with an increasing incidence in Europe and the USA as a result of the high prevalence of     hepatitis C. Most patients are not suitable for potentially curative treatment. There is no     standard palliative treatment for patients with advanced hepatocellular carcinoma (HCC), as     no drug has been demonstrated to be efficient in this disease in terms of survival. The use     of anti-vascular agents might be a promising approach in view of the highly vascular nature     of this tumor. The aim of this phase II trial is to evaluate the potential benefit of     bevacizumab in terms of disease control rate, progression-free and overall survival in adult     patients with advanced primary liver cancer. Bevacizumab is an angiogenesis inhibitor already     successfully used in patients with colorectal and renal cancers.   "
177842|NCT00162682|"     The purpose of this study is to determine if a decision to switch to a subsequent     antiretroviral regimen based upon the CD4 cell count rather than the standard switching     strategy based on viral load could ensure the same immunological and clinical outcome and     preserve future treatment options in AIDS patients   "
177843|NCT00162695|"     Objective of the study objectives was to explore survival advantage for an intensified     chemotherapy strategy in a randomised trial.      IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin,     epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g     (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was     determined according to site and / or response to chemotherapy ± surgery.      The study was powered to detect 10% difference in 3 year OS.   "
177844|NCT00162708|"     Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be     two possibilities for improving efficacy of radiotherapy in locally advanced head and neck     carcinomas. In this multicentric study, we tested the hypothesis that accelerated     radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU,     aiming to improve both local control and on distant metastases as compared to very     accelerated radiotherapy.   "
177845|NCT00162721|"     This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant     radiotherapy in the treatment of non-metastatic uterine sarcomas.   "
177846|NCT00162734|"     This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of     two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily     for 48 weeks and no treatment in patients chronically infected with hepatitis C who are     nonresponders to previous pegylated interferon alfa plus ribavirin therapy and participated     during at least 24 weeks of no treatment in IRHC-001.      At the time of randomization into IRHC-001, the no treatment arm patients will be     concurrently randomized in a 1:1 ration to receive Interferon Alfacon-1 (9 or 15 µg) +     Ribavirin (both administered daily) or no treatment for up to 48 weeks. Patients will not be     eligible for consideration to receive treatment in IRHC-002 until they have completed a     minimum of 24 weeks of participation in IRHC-001.      The protocol and informed consent form that will be used must be approved by the     Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the     study is initiated.   "
177847|NCT00162747|"     The purpose of this study is to determine how to best take care of the skin of preterm     infants in order to prevent infections through the skin.   "
177848|NCT00162760|"     The goal of this study is to determine whether thalidomide can stop the progression of     fibrosis in IPF.      The primary objective of this study is to determine the safety, feasibility and efficacy of     400 mg of thalidomide administered daily for one year in patients with idiopathic pulmonary     fibrosis (IPF) who have failed or are not candidates for treatment with corticosteroids     and/or cytotoxic drugs.      The study population will consist of patients with biopsy-proven moderate to severe IPF who     have failed or are not candidates for standard therapy with corticosteroids and/or cytotoxic     drugs.   "
177849|NCT00162773|"     The purpose of this study is to find out if omalizumab is effective in treating non-allergic     asthma. The US Food and Drug Administration has approved the use of omalizumab to treat     moderate to severe allergic asthma.   "
177850|NCT00162786|"     The primary objective of this study is to measure and compare the acute effects of rupatadine     10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers’     performance on a standard over-the-road driving test and a car-following test.   "
177851|NCT00162799|"     To explore the efficacy of triflusal in the attenuation of insulin resistance in human     obesity. Triflusal is a salicylate compound approved in several countries as antithrombotic     agent (antiplatelet). The hypothesis is to explore if there is a reduction of obesity-induced     insulin resistance by triflusal.   "
177852|NCT00162812|"     prospective evaluation of topoisomerase II alpha gene amplification and protein     overexpression as markers predicting the efficacy of epirubicin in the primary treatment of     breast cancer patients.   "
177853|NCT00162825|"     Role of CD7 in skin inflammation and psoriasis   "
177854|NCT00162838|"     Periodontitis develops due to subgingival infection with specific microbial pathogen from     dental plaque. The bacteria can activate immunoinflammatory mechanisms within the local     periodontal tissues that lead to destruction of collagen and alveolar bone. Human gingiva     contains Langerhans and connective tissue dendritic cells. Signals from periodontal pathogen     can induce dendritic cells to maturation,rapidly increasing surface expression of MHC class     II, costimulatory molecules, and secrete proinflammatory cytokines to regulate adaptive T     cell immune response. Studies on cytokines have led to controversy about different T cell     subsets associated with the progression of periodontitis. Seymour proposed that     susceptibility to periodontal disease progression involve a predominantly Th2 response while     Ebersole speculated that Th2 cells providing protective function. It is possible that a given     pathogen may produce different maturation signals by activating DCs induce a given type of     immune response. In this study, we observed the profiles and amounts of cytokine production     of DCs stimulated with P. gingivalis and T. forsythensis compared with E. coli, to see     whether the periodontal pathogens may induce different response of dendritic cells in the     innate immunity.   "
177855|NCT00162851|"     This is a Phase II trial to study the safety and tolerability of subcutaneous alemtuzumab     administered without dose escalation to patients with advanced B-cell chronic lymphocytic     leukemia (B-CLL).   "
177856|NCT00162864|"     This randomized, double-blind, placebo-controlled trial assessed the efficacy of montelukast     in the treatment of adults ≥50 years of age with persistent asthma and/or COPD. Primary     outcomes included forced expiratory volume in one-second (FEV1) and daytime asthma symptoms     scores. Nocturnal symptoms, asthma control, health-related quality of life, peak flow     measurements, and health care utilization were also assessed as secondary outcomes.     Participants were recruited from the Kaiser Permanente Northwest member population. One     hundred forty-nine subjects were randomized to treatment with montelukast (10 mg per day) or     placebo, and were followed for a six-week period. No differences in lung function measures,     health-related quality of life, health care utilization, and asthma symptom scores were     observed; however, the montelukast group had slightly improved asthma control scores compared     to the placebo group.   "
177857|NCT00162877|"     The objective of this trial is to find the rationale and the optimal dose and duration of     regimen for the eradication of H. pylori infection using different proton pump inhibitors.   "
178349|NCT00178100|"     This study will evaluate the effectiveness of paroxetine versus interpersonal psychotherapy     and a combination of the two in helping elderly patients with depression remain well and     improve quality of their lives.   "
177858|NCT00162890|"     The specific aims are as follows:        1. To investigate the degree of impairment, such as range, proprioception, sensation, and          electromyography (EMG) pattern of healthy, older subjects.        2. To investigate the relationship of these impairment measurements, the functional outcome          and disability in patients with cervical spondylosis.        3. To develop an exercise program with an emphasis on proprioception, stability and          coordination for patients with neck-shoulder complaints to decrease the impairment and          increase the functions of patients.   "
177859|NCT00162903|"     BACKGROUND Patent ductus arteriosus (PDA) is a frequent clinical event in preterm infant. The     cardiopulmonary functions of these preterm babies may be adversely affected by the patency of     ductus arteriosus. Ductal tissues are sensitive to the constricting effect of endothelin-1     and the dilating effect of prostaglandins, inflammatory mediators, and concentration of     oxygen.      OBJECTIVE To examine the role of endogenous nitric oxide (NO) and endothelin-1 (ET-1) in the     pathogenesis of patent ductus arteriosus of the preterm infants. We hypothesize that the     patency of ductus arterious in preterm infants is probably due to inappropriate production of     endogenous nitric oxide and the interaction with various inflammatory mediators and     prostaglandins, which is different from those of term infants. In addition, the secretion of     endothelin is probably decreased. The purpose of this study is to monitor the changes of     these substance sequentially, and to evaluate the relationship among endothelin-1, endogenous     nitric oxide, and inflammatory mediators in the pathophysiology of patent ductus arteriosus     in preterm infants.      METHODS AND MATERIALS        1. Inclusion criteria:             1. Preterm infants with gestational age less than 32 weeks or birth weight less than               2000 gm.             2. Informed consent        2. Numbers of study population:           With 80-100 evaluable infants (40-50 patients in PDA and non-PDA groups, respectively)        3. Blood sample, collecting on day 1,3,7 after regular echocardiographic evaluation, is          assessed for inflammatory mediator (IL-8, IL-10), nitric oxide metabolites (nitrite and          nitrate), endothelin-1, and cGMP        4. Statistical analysis: Student t-test testing the differences of clinical data, Wilcoxon          signed rank test for comparing data obtained between the PDA and non-PDA patients, the          PDA patients before and after intravenous indomethacin, and those who are responsive or          refractory to the therapy.   "
177860|NCT00162916|"     The purpose of the study is to explore to what extent continuing the antidepressant     medication citalopram (Celexa), after depression has responded to treatment, helps prevent     the return of depressive symptoms in patients with recent traumatic brain injury (TBI).   "
177861|NCT00162929|"     The purpose of this study is to determine the maximum tolerated dose and/or maximum     attainable dose of a vaccine consisting of human autologous dendritic cells transduced by an     adenovector expressing rat Her-2/neu (AdHer-2/neu) in patients with metastatic breast cancer.   "
177862|NCT00162942|"     The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn     Apheresis System as a treatment for the signs and symptoms of Crohn's disease.   "
177863|NCT00162955|"     The purpose of this study is to assess the protective effect of Valsartan on chronic     cardiotoxicity induced by CHOP.   "
177864|NCT00162968|"     Many people with polyneuropathy suffer from pain which is difficult to treat. Escitalopram is     a relatively new drug used in the treatment of depression. Escitalopram’s action mechanism on     the brain suggests that escitalopram also may have an effect on neuropathic pain. This study     will test the efficacy of escitalopram in patients with painful polyneuropathy.   "
177865|NCT00162981|"     The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive     therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2     to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at     approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be     randomly assigned to either a low dose or a high dose. The study will include a baseline     period, a titration period and a maintenance period. After the maintenance period, subjects     will either continue into an open-label extension study or enter the taper period with a     final visit 1 week after the last dose.   "
177866|NCT00162994|"     The purpose of this study is to find out if young children have more benefit of the     combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent     otitis media.   "
177867|NCT00163007|"     Prospective, short-term studies in patients admitted for acute stroke have shown an increased     risk of infections, bedsores, impaired functional outcome, slower rate of recovery, poorer     rehabilitation potential and higher mortality in patients with a poor nutritional status. In     hospitals without routine nutritional assessment and individual nutrition management plans,     the risk of patients developing malnutrition may be increased. In this study, patients     admitted for acute stroke are randomised into either receiving nutritional therapy derived     from estimated individual nutritional intake and nutritional needs, or nutritional therapy     based on routine care without routine assessment of nutritional status, intake, or needs. The     primary outcome measure is the percentage of patients with weight loss ≥ 5 % at three month     follow-up.   "
177868|NCT00163020|"     Hypothesis: Among women with twin or triplet pregnancies, weekly injections of     17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will     reduce neonatal morbidity by reducing the rate of preterm delivery.      This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus     placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk     factor for preterm birth. The two risk factors to be studied are:        1. Twin pregnancy        2. Triplet pregnancy   "
177869|NCT00163033|"     Estetrol is a natural compound that is produced by the fetus during fetal life and circulates     in the unborn child and the mother. It is an estrogenic compound. In this study the safety     and tolerability of 28 days of the oral administration of estetrol in healthy postmenopausal     women are investigated. In addition, the pharmacokinetics and some pharmacodynamic parameters     are studied. The lowest dose of 2 mg estetrol is directly compared with 2 mg estradiol.   "
177870|NCT00163046|"     The purpose of this study is to to assess the effect of gabapentin compared to placebo on     sleep, using polysomnography along with subjective sleep assessments, in subjects with     transient insomnia induced by a sleep phase advance.   "
177871|NCT00163059|"     To determine if the NMDA antagonist, CP-101,606, is effective for depression   "
177872|NCT00163072|"     Rationale: Megestrol acetate (Megace®) is a progestin analog that is FDA approved for the     palliative treatment of breast and endometrial carcinoma. It is also commonly used as an     appetite stimulant, particularly in HIV and cancer patients with poor appetite from their     primary disease and/or their therapy. Megace is well absorbed orally, however, many patients,     particularly younger ones have difficulty taking oral medications. Transdermal progestins are     available and are FDA approved. For example, Ortho EvraTM is a transdermal contraceptive     patch containing an estrogen (ethinyl estradiol) and a progestin (norelgestromin).      Key Objectives: Compare the pharmacokinetics of orally administered vs. transdermal Megace     and determine if there are any local side effects of the transdermal route.   "
177880|NCT00163176|"     Tumor cell proliferation and repopulation contribute to resistance to radiotherapy in head     and neck cancer. Up to now, this characteristic is mostly assessed using biopsies acquired     during inspection under general anaesthesia before treatment.      18F-FLT-PET (positron emission tomography) is a non-invasive imaging method showing areas of     active proliferation. The aim of this study is to assess the value of the functional     information gained by 18F-FLT-PET for radiotherapy planning and early tumor response     assessment.      Prior to radiotherapy, a planning CT-scan and a 18F-FLT-PET scan are acquired. After     approximately two weeks of radiotherapy a further PET scan is obtained.   "
177881|NCT00163189|"     To estimate the evolution of height and growth rate over 5 years of growth hormone (GH)     treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the     good clinical and biological safety of GH treatment in such children   "
177882|NCT00163202|"     The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as     compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week     treatment period in subjects with documented coronary artery disease.   "
177883|NCT00163215|"     To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in     standard deviation (SD) after 3 years will be compared to growth rate before the start of GH     treatment.   "
177884|NCT00163228|"     In this study, a functional evaluation of total knee arthroplasty (TKA) patients is     performed. The patients are measured prior to surgery and 6 and 12 months after surgery. The     measurements consist of questionnaires and rising from a chair. Also, two types of TKA are     functionally evaluated. At last, the TKA group will be compared to a THP group.   "
177885|NCT00163241|"     Objectives of the study:      Primary: Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo     administered once daily (QD) for 24 months in slowing disease progression as assessed     radiographically in subjects with osteoarthritis (OA) of the hipSecondary:Assess the ability     of a continuous treatment of celecoxib 200 mg versus placebo administered QD for 24 months in     treating disease signs and symptoms in subjects with OA of the hip.Evaluate the ability of a     continuous 24-month intake of celecoxib 200 mg QD versus placebo to reduce number of subjects     eligible for hip replacement according to the investigator.Evaluate the tolerability and     safety of a continuous 24-month intake of celecoxib 200 mg QD versus placebo in subjects with     OA of the hip.   "
177886|NCT00163254|"     The Below-Study is a randomized, prospective mono-centre trial on the efficacy and safety the     adjunctive use of a GP IIb/IIIa antagonist for prevention of early reocclusion in arterial     below-the knee interventions.   "
177887|NCT00163267|"     The Mirror Study is a randomized, double-blinded mono-centre trial the access the     periinterventinal and postinterventional administration of clopidogrel in patients with     peripheral vascular disease.   "
177888|NCT00170443|"     This study will compare the safety and immunogenicity of three different dose levels of an     experimental recombinant influenza HA protein vaccine to a standard inactivated influenza     vaccine in heallthy elderly subjects ages 65-80. Blood and nasal secretions for assessment of     antibody responses will be obtained from all subjects prior to and one month after     vaccination.   "
177889|NCT00170456|"     This is a dose ranging study comparing different vaccine schedules of rPA vaccine for     anthrax. Safety and the capability to induce an immune response will be evaluated.   "
177890|NCT00170469|"     This is a dose ranging study comparing different vaccine schedules of rPA vaccine, for     Anthrax, to the licensed dose of AVA, another Anthrax vaccine. Safety and the capability to     induce an immune response will be evaluated.   "
177891|NCT00170482|"     The body's immune system (fights infection) is known to decline during the aging process,     resulting in an increased risk of catching infections. Vaccinations also are not as effective     in protecting older people against infection as they are in younger people. The purpose of     this study is to better understand how and why vaccines are not as effective in older people.     The researchers believe that the immune response in older people who get a higher dose     vaccine will be similar to the immune response in young adults who get the standard (lower)     dose vaccine. This study is a substudy to a main study, evaluating flu vaccines in people 65     years and older. Volunteers who are in the main study will be asked if they will participate     in the substudy. The substudy requires them to give 2 additional blood samples for an     in-depth look at their immune response to the flu vaccine given in the main study. Substudy     volunteers will have up to 3 clinic visits and participate up to 28 weeks.   "
177892|NCT00170495|"     This study is designed to assess the causes and impact of acute respiratory illness (common     colds, flu, bronchitis, pneumonia) in adults age 65 and older. One of the ways to determine     the virus causing a particular illness is to get a blood specimen when a person is sick and     again later and look for the body's specific responses that identify the virus. Approximately     3000 subjects will be evaluated and their medical records assessed for details of recent     illness and general health to help in understanding the subjects' current illness.   "
177893|NCT00170508|"     This is a complimentary study to an elderly influenza study. Subjects 18-40 will receive a     single dose flu vaccine and be evaluated for humoral and cell mediated immunity to influenza     antigens.   "
177894|NCT00170521|"     The purpose of this study is to determine the epidemiology of throat isolates of group A     streptococci among 3-15 year-old children with pharyngitis (sore throat) living in Leon,     Nicaragua.   "
177895|NCT00170534|"     The specific aim of this study is to complete an ongoing randomized controlled trial of the     efficacy of behavioral intervention compared to STI treatment/HIV counseling alone in     decreasing risk behavior and incident HIV/STI infections in Mumbai, India.   "
177896|NCT00170547|"     This protocol is to compare the immune response of different influenza vaccines given by two     different routes of administration in healthy adults ages 18 to 64 years.   "
177958|NCT00174408|"     The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in     short children born SGA. Safety of the drug is a main objective as well. The growth promoting     effect of two different dosages is compared. The effect of long-term treatment on final     height is evaluated (according to several amendments)   "
177959|NCT00174421|"     This trial evaluates whether long-term treatment with Genotropin normalizes final (adult)     height in short children born small for gestational age   "
177897|NCT00170560|"     The purpose of this study is to better understand the relationship between gender (being a     man or a woman), infections caught in the hospital, and serious illness. Five hundred seventy     patients 18 years of age or older who are critically (seriously) ill and admitted to the     Intensive Care Unit (ICU) for at least 48 hours will participate in this study. Patients will     be studied while receiving regular ICU treatment according to local standards. Blood     specimens will come from patients either as wasted blood (University of Virginia) or blood     collected from patients specifically for the study (Vanderbilt University). All patients will     be followed daily until death or discharge from the ICU. The researchers believe that they     will find a similar risk of infection for men and women overall.   "
177898|NCT00170573|"     Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of     recurrent ovarian cancer (ROC). Toxic skin reactions were reported as being the dose-limiting     toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study     was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL     was investigated. Secondary objective of this study was to evaluate the response rates of     this new regimen.   "
177899|NCT00170586|"     Bloodborne pathogens are infectious bacteria, viruses, or other disease-causing germs carried     in blood or other body fluids. These germs include hepatitis B and C viruses and HIV.     Surgical and examination gloves are worn by health care workers to reduce the risk of workers     catching germs from patients or patients catching germs from workers. The purpose of this     study is to further develop polyvinylidene fluoride coatings for use as a protective coating     worn underneath the gloves. Some health care workers may have tiny cuts on their hands that     need to be protected, and gloves can have defects such as tiny holes that can allow germs to     travel through them. The undercoating can add an additional layer of protection under gloves.     The coating is applied in liquid form to hands and dries as a film without wrinkling,     tearing, lifting, or bubbling. The liquid contains chemicals that fight germs. The coating     also provides protection from skin irritation caused by the latex in some gloves.   "
177900|NCT00170612|"     Pneumonia is the most common reason for admission of Fijian children to hospitals. The most     common germ causing pneumonia is streptococcus pneumoniae. It is a common cause of     meningitis (infection around the brain and spinal cord), ear infections, and blood infections     and it lives in the nose of humans. A vaccine has been developed that will help prevent these     common diseases but prevents only about one quarter of pneumonia cases and it is expensive.     This study explores new ways of giving this vaccine that are affordable, safe, and effective     in countries such as Fiji. About 550 Fijian infants presenting at 6 weeks of age, for their     first diptheria, tetanus, toxoid, pertussis vaccine immunization, to one of the participating     Health Centers or Colonial War Memorial Hospital in urban Suva, Fiji will be enrolled.     Children will remain in the study for 2 years. Study procedures include full vaccination     against 7 types of pneumococcus, blood tests, and nasal swabs.   "
177901|NCT00170625|"     Compatibility of the topotecan therapy in combination with carboplatin.   "
177902|NCT00170638|"     The purpose of this study is to gain a better understanding of how immunity to tuberculosis     (TB) is maintained in children. When children get tuberculosis, it is more likely to spread     to other parts of the body than when adults get it. This study will compare the blood cells     that fight TB in children to the blood cells that fight TB in adults. Children enrolled in     this study will have blood drawn on 1 or 2 occasions. Adult participants will be     leukapheresed, a process in which blood passes through a machine collecting specific blood     cells and returning the remaining blood to the body. An estimated 260 subjects will be     enrolled in this study.   "
177903|NCT00170664|"     The combination of paclitaxel and carboplatin in a three weeks schedule has emerged as the     current standard approach for the adjuvant treatment of ovarian cancer. Based on a phase I     study now a multi-center phase II-trial was conducted.   "
177904|NCT00170677|"     Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to     be examined.   "
177905|NCT00170690|"     Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of     therapy for the patient)   "
177906|NCT00170703|"     The primary objective of this feasibility study is to evaluate the safety and effectiveness     of targeted sub-threshold epidural cortical stimulation delivered concurrent with     speech-language rehabilitation activities to enhance recovery in study subjects suffering     from Broca's aphasia (the inability to speak or to organize the muscular movements for     speech), following a stroke.   "
177907|NCT00170716|"     The purpose of this study is to assess the safety and effectiveness of cortical stimulation     delivered concurrent with rehabilitation activities to enhance motor recovery in patients     suffering from hemiparesis affecting the upper extremity following a stroke.   "
177908|NCT00170729|"     The primary objective was to demonstrate that two days of treatment with 0.5% prednisolone     acetate eye-drops after cataract surgery are superior to vehicle in reducing the flare in the     anterior chamber of the operated eye.   "
177909|NCT00170742|"     Phase III study comparing monthly octreotide i.m. in comparison to no additional treatment in     patients with proliferative diabetic retinopathy after lasercoagulation.   "
177910|NCT00170755|"     This study will evaluate the safety, tolerability and efficacy of darifenacin, in the     long-term treatment of adult patients with overactive bladder.   "
177911|NCT00170768|"     The purpose of this study is to explore the possible cognitive effects of darifenacin     modified release and long-acting oxybutynin.   "
177912|NCT00170781|"     This study is designed to develop our understanding of the efficacy and safety of using     lumiracoxib in the treatment of patients with acute gout. This is a multi-center,     double-blind, randomized, parallel group study comparing a single daily dose of 400 mg     lumiracoxib with the established dose of indomethacin 50 mg taken three times a day in terms     of efficacy   "
177913|NCT00170794|"     The purpose of the study is to determine the extent of cyclosporine microemulsion dose     reduction required to maintain stable renal function in maintenance cardiac transplant     recipients, after initiation of everolimus.   "
177960|NCT00174434|"     This study is to evaluate the safety of SU011248 in combination with paclitaxel in patients     with metastatic or locally recurrent breast cancer who have not received chemotherapy     treatment in the advanced disease setting.   "
177914|NCT00173836|"     Significant evidence has shown that radiation therapy for patients with nasopharyngeal cancer     (NPC) can cause swallowing abnormality. Based on our prior cross-sectional study for 184 NPC     patients from 1995 to 1999, the findings of videofluoroscopic swallowing study (VFSS)     revealed continuous deterioration of swallowing function of these patients even many years     after radiation. We conducted a prospective study to evaluate the longitudinal change of     swallowing function based on VFSS before, one month, one year and two years after completing     radiation therapy. The amount of saliva was measured at the same time of VFSS study to test     the relationship of decreased amount of saliva and swallowing function. Comparison of serial     VFSS studies in NPC patients (n=84) and normal volunteers (n=38) were obtained. We assume     that this study may reveal a complete understanding of changing swallowing patterns in the     course of radiation therapy of patients with NPC. From this study, NPC patients can     understand their own swallowing function. Therefore, the information may enable for earlier     intervention of swallowing training or correction to avoid morbidity of radiation therapy in     this patient group.   "
177915|NCT00173849|"     Investigate the role of SDF-1/CXCR4 in the metastasis of oral squamous cell carcinoma   "
177916|NCT00173862|"     The purpose of this study is to evaluate the efficacy of Gemcitabine plus Ifosfamind as     second line chemotherapy in advanced transitional cell carcinoma in terms of response rate     and overall survival .   "
177917|NCT00173875|"     The purpose of this study is to assess the overall response rate to Iressa as a first-line     treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer (NSCLC)   "
177918|NCT00173888|"     The purpose of this study is to evaluate the 1-year treatment failure rate of two sequential     chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and     gemcitabine plus cisplatin followed by weekly docetaxel。   "
177919|NCT00173901|"     The purpose of this study is to understand whether generic ceftazidime causes different     adverse drug reaction incidence from the brand drug.   "
177920|NCT00173914|"     Progressive cardiac allograft vasculopathy (CAV) is a serious complication in long-term     survivors after heart transplantation. Therefore, we hypothesize that CAV is a diffuse and     progressive process, and endothelial function may play an important role in predicting     clinical outcome after heart transplantation. Therefore, this single-blinded study is     designed to evaluate endothelial function, microvascular flow response and morphology of     coronary artery in cardiac allografts,        1. The simultaneous use of IVUS and Doppler wire instrumentation in different          pharmacological stress;        2. Tl-201 SPECT (dipyridamole stress/rest); to evaluate the correlation of endothelial          function, coronary morphology change and Tl-201 dipyridamole stress myocardial perfusion          image.   "
177921|NCT00173927|"     The goals of this trial are:        1. To compare the sensitivity and specificity of various tools including Doppler and          magnetic resonance imaging (MRI) for diagnosing vertebral artery stenosis and carotid          artery stenosis. The positron emission tomography (PET)/MRI fusion imaging will be a          promising tool to provide both anatomical and functional imaging for vulnerable plaques.        2. To identify patients at high risk of plaque rupture by image studies, biomedical          profile, and gene expression of circulating monocytes.   "
177922|NCT00173940|"     In summary, the researchers want to construct a longitudinal data bank using voluntary health     examination participants. Researchers in the National Taiwan University Hospital (NTUH)     campus can utilize these data to clarify the effects of several genetic and environmental     factors on various common diseases in Taiwan in the future.   "
177923|NCT00173953|"     The aims of this study are 1) to determine the cytokines produced by both Th1 and Th2 subsets     in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori     therapy; 2) to obtain a detailed phenotypic characterization and distribution pattern of     mucosal lymphocytes in H. pylori-associated gastritis and to define possible contributing     immune mechanisms responsible for the chronicity of the disease and its associated lesions.   "
177924|NCT00173966|"     Endothelial function is closely related to the hemostasis , vascular tone, and organ     perfusion in cardiovascular system, and its dysfunction would cause overactivation of the     coagulative system to induce thrombus formation. So we study the relationship between the     endothelial function and atrial fibrillation.   "
177925|NCT00173979|"     This current study tests whether the load-displacement and stress-strain characteristics of     human bicep and tricep muscles and tendons change during graded maximal voluntary elbow     extension and flexion exercises.   "
177926|NCT00173992|"     The specific aims of this research are delineated as the following:      Aim 1: To investigate the neuromuscular and biomechanical mechanisms of the emerging     processes of proactive and reactive balance control during sitting and standing in patients     with stroke at different stages of the recovery course.      Aim 2: To determine the relationships between brain lesion sites and the recovery patterns of     reactive and proactive balance control mechanisms in patients with stroke.      Aim 3: To determine the relationships between the impairments in reactive and proactive     balance control mechanisms and functional outcome as well as fall incidence in patients     following stroke.      Aim 4: To investigate the efficacy of different training regimens in improving reactive and     proactive balance control strategies and in preventing falls in stroke patients with     different brain lesion sites.      Principally, three hypotheses are to be tested:      Hypothesis 1:The emerging processes and recovery patternes of proactive and reactive balance     control may be different among stroke patients with different brain lesion locations.      Hypothesis 2:There are positive correlations between the level of impairments in reactive and     proactive balance control mechanisms and functional outcome as well as fall incidence in     patients following stroke.      Hypothesis 3:Training regimens that could best facilitate the emergence or improvement in     reactive and proactive balance control strategies are different.   "
177927|NCT00174005|"     The purpose of this study is to estimate the validity and reliability in the measurement of     bicep and tricep tendons and muscular morphologic characteristics by using ultrasound.   "
177928|NCT00174018|"     To investigate validity and reliability in measuring the subacrominal space by using     ultrasound   "
177929|NCT00174031|"     To investigate prevalence and profile of sports injury in Taiwanese adolescent baseball     players in a longitudinal study.   "
177961|NCT00174447|"     Open label extension study of Ziprasidone, evaluation of safety of long term use of     ziprasidone   "
177930|NCT00174044|"     Tripping over obstacles is one of the common movements in daily life and is the most     frequently mentioned cause of falls in the elderly. Indeed, crossing obstacles is a more     complex motor skill than walking, and ensuring sufficient clearance of an obstacle during     locomotion requires accurate movement and appropriate modifications of the swing limb.     However, little is known about the obstacle crossing deficits that following stroke,     especially in good outcome and function independently strokes. It is still a mystery about     motor control and motor plastic of central nerve system.      The purpose of the study was to observe and quantify certain characteristics of the     performance of subjects following stroke with good outcome to understand the damage of     central nerve system how to affect motor control. The present study investigated selected     spatial-temporal characteristics, kinematic variables and kinetic variables of the gait     pattern to define further the problems in obstacle crossing following strokes. To quantify     the deficits, we compared results from a group of subjects with stroke with a group of     healthy subjects matched for age, gender, and height.   "
177931|NCT00174057|"     The exact mechanism of the pathogenesis of Graves’ ophthalmopathy is still unknown.     Histopathologically, extraocular muscle inflammation and orbital fat inflammation are two     prominent changes. In the past year, we had investigated the morphological features of the     Müller muscle in patients with thyroid lid retraction using the special stain and     immunohistochemistry. In our findings, the smooth muscle cells, in the diseased group, were     replaced by variable adipose and fibrosis tissues.      In recent years, TSHR, has been verified to express in orbital connective tissue and     extra-ocular muscle. From functional studies and an increase in adipogenesis in cultured     fibroblasts with expression of TSHR protein, the role not only the target but effector cells     in orbital fibroblasts were validated. Quantitative RT-PCR may help to differentiate whether     a less extent of expression at the end stage or low protein amount to be detected.      In recent years, the diverse phenotypes of orbital fibroblasts, with regard to expression of     Thy-1 protein or not, had been reported from several studies, the investigators believed     heterogeneity in orbital fibroblast may determine the clinical presentation of     Graves’ophthalmopathy. We also are curious to know if the phenotypic heterogeneity of the     fibroblasts in the ocular adnexal and orbital tissues correlates to distinct morphological     features of adipogenesis and fibrosis.      Moreover, increased CD40 expression in skin fibroblasts were noted from patients with     systemic sclerosis. Expression of IGF-I and IGF-IR seemed to be up-regulated in processes of     several fibrotic diseases. A nuclear transcription factor, PPAR-γ, has been verified to have     a close relationship with adipogenesis. We hypothesize that some immunological processes     involve the ocular adnexal and orbital tissues, which result in various ophthalmological     manifestations.      The purpose of this study is to investigate the different stage of the ocular adnexal and     orbital tissues to identify the pathogenesis of Graves' ophthalmopathy by frozen sections     with Immunohistochemistry, mRNA expression of TSH receptor, PPAR-γ, IGF-1R, and IGF-1 and     different cytokines using quantitative RT-PCR and flow cytometry at the acute and stable     stage in GO.   "
177932|NCT00174070|"     Acute respiratory failure (ARF) remains a common reason for admission to the intensive care     unit (ICU). ARF to be present in 32% of patients on ICU admission, with a further 24% of     patients developing ARF during the ICU stay. A total of 56% of all ICU admissions for a     length of >48 h had ARF at some point during their stay. The incidence of ARF was from 88.6     to 137.1 hospitalizations per 100,000 residents. The incidence of ARF was found to increase     nearly exponentially with each decade until age 85 years. However, there is still paucity     data about etiology and outcomes of acute respiratory failure happened in community.      Mortality of ARF in critically ill patients is between 40% and 65%. Independent hazards for     ARF mortality include older age, severe chronic co-morbidities (HIV, active malignancy,     cirrhosis), certain precipitating events (trauma, drug overdose, bone marrow transplant), and     multiple organ system failure (MOSF) [7-9]. Mortality has also been associated with acute     lung injury or bilateral infiltrates on chest radiograph, and with an elevated acute     physiology score.      ARF patients form a large percentage of all ICU admissions and many factors might influence     the final outcomes. With the high incidence of ARF in ICU, any improvement in the outcome of     such population is likely to have marked effect on intensive care resource allocation. We     wish this study may provide some valuable information about acute respiratory failure in     community and improve the outcome of these patients.   "
177933|NCT00174083|"     Recent studies revealed that the ex vivo enzyme-linked immunospot (ELISPOT) assay for gamma     interferon is a specific method for contact tracing of Mycobacterium tuberculosis infection.     However, its use in endemic area and bacillus Calmette-Guérin (BCG)-vaccinated hosts has not     been proved. We hypothesize that the TB-ELISPOT assay can be a rapid and accurate diagnostic     tool for active tuberculosis in clinical suspects in Taiwan.   "
177934|NCT00174096|"     The purpose of this study is to investigate the relationship between SDF-1/CXCR4 and     metastasis of laryngeal and hypopharyngeal squamous cell carcinomas.   "
177935|NCT00174109|"     Clarify the relation of microtubule-associated protein 2 and cell migration   "
177936|NCT00174122|"     Nowadays, a physician plays a more important role in managing patients with potential     infectious complications in the emergency room. Previous studies demonstrated the importance     of early and adequate anti-microbial therapy in reducing the mortality and morbidity of     patients with severe sepsis. However, in one study, about 6% of clinically significant     bacteremic patients were misdiagnosed and discharged from the emergency room. In other     studies, about 8.5 to approximately 17% of empirical antibiotic selection was judged     inappropriately according to subsequent microbiology, and anti-microbial susceptibility was a     result. It reflects the diversity in the presentations of infectious diseases and limited     available microbiological reports from the first-line emergency physicians. Timely diagnosis     and selection of appropriate antibiotics/treatment in treating those patients challenge an     emergency physician more than ever before.      A serum marker, procalcitonin, was recently demonstrated to be a potential indicator in     distinguishing between non-infectious and infectious acute inflammatory reactions, viral and     bacterial infections, and non-bacteremic and bacteremic infections. It also demonstrates the     association with high-mortality risk in patients with severe sepsis. However, some areas     remain inconclusive in the clinical application of this potential serum marker.      The investigators designed this prospective study with the following purposes:        1. To clarify the sensitivity and specificity of the serum procalcitonin quantitative test          as a clinical indicator of sepsis;        2. To identify the cut-off value of the serum procalcitonin level in sepsis screening among          various groups of patients with different co-morbidities;        3. To test the potential role of the procalcitonin quantitative test in identifying occult          sepsis in patients with an acute undifferentiated febrile reaction in the emergency          room;        4. To test the possibility of the sequential procalcitonin quantitative test as a          serological guide of the appropriateness of an empirical antibiotic before the          microbiology results are available.      Conclusions in the investigators' study will clarify the clinical application of the serum     procalcitonin quantitative test in the differential diagnosis of patients with systemic     inflammatory reaction syndrome, the screening of high-risk sepsis patients, and the     effectiveness of an empirical antibiotic evaluation.   "
177962|NCT00174460|"     Safety and efficacy of Somatropin will be evaluated in short children born with a list weight     below 1500 g and that did not catch up to normal height at the age of 4.   "
177963|NCT00174473|"     This is a study to investigate the pharmacokinetics, safety and tolerability of several doses     of voriconazole, intravenous and oral suspension formulations, in children   "
177964|NCT00174486|"     Assessment of duration of action, safety & toleration of different formulations and doses of     UK-369,003 and Cialis in patients with male erectile dysfunction. Patients should have     previously been on PDE5 inhibitors and have been respondents to the drug. Duration of     treatment is 4 weeks.   "
177965|NCT00174499|"     The purpose of this research study is to evaluate the effects on existing tooth stain of     nicotine gum. The study will enroll adults who have visible tooth staining.   "
178350|NCT00178113|"     The purpose of this study is to determine whether dietary lycopene supplementation lowers     serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia     (HGPIN).   "
177937|NCT00174135|"     Health promotion in the elderly has been a major recent public health concern. Sarcopenia is     a term utilized to define the loss of muscle mass and strength that occurs with aging. It has     been demonstrated to be associated with decreased functional capacity among the elderly. The     magnitude of the public health problem posed by sarcopenia is not yet established. The     purposes of this study are to investigate sarcopenia and its relationship with functional     status in elderly Taiwanese community-dwellers, and to develop the preventive strategy for     sarcopenia in the elderly. Firstly, the investigators will recruit 100 volunteers (aged 18-90     years old) to participate in this study. All of the participants will receive bioelectric     impedance analysis (BIA), muscle strength and endurance assessment, physical activity level     assessment by a seven-day recall questionnaire, protein intake assessment, cognition     evaluation (Mini-Mental State Examination) and functional status assessment by the Functional     Independence Measurement (FIM) questionnaire. A multiple regression model will be used for     statistical analyses. Then, this project will be used to evaluate the efficacy of a 12-week     supervised resistance strengthening exercise program for sarcopenia in the elderly.     Participants who are defined as having sarcopenia from the previous examination will be     randomized into either the exercise or control groups. Subjects in the exercise group will     receive resistance strengthening exercises 3 times per week for 12 weeks. All measurements     will be performed as described above. The investigators expect that resistance exercises are     effective in offsetting age-related decline of muscle mass and strength in the elderly.   "
177938|NCT00174148|"     Systematically assessing the proprioception-coordination capacity of the spine in patients     with different severity of neck disability could reveal how the dysfunction of the     sensory-motor system was progressed. From the result of the research, a prospective study     would be designed to test the hypotheses that described the mechanism of neck pain based on     the results to the present study.   "
177939|NCT00174161|"     The purpose of these series research project is to investigate the prevalence, symptoms     cluster and characteristic; establish the systemic symptom management nursing strategies     (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health     related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP     offers a research and clinical based protocol to demonstrate the independent nursing role and     practice care model. The 3-year series research process will include three research domains.   "
177940|NCT00174174|"     The primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness     associated with narcolepsy. Both of the subjective and objective sleepiness of the patients     were assessed in the experiment by repeat measures.   "
177941|NCT00174187|"     -  To assess the effect of a long-term treatment by Genotonorm on linear growth in children          with short stature receiving steroid therapy        -  To assess the effect of a long term treatment with Genotonorm on bone mineralisation        -  To assess the effect of a long term treatment with Genotonorm on body composition   "
177942|NCT00174200|"     To assess the effect of risperidone 2 mg daily (QD) on the differential sensitivity of 2     spatial working memory tests (the GMLT and MDR) in non-agitated, drug-naive patients     suffering from first-episode schizophrenia/schizophreniform disorder.   "
177943|NCT00174213|"     The purpose of this study is to estimate the validity and reliability in measuring the     iliotibial tract by using ultrasound.   "
177944|NCT00174226|"     Determine if there is a difference in treatment response for adults with ADHD who are treated     with Strattera versus those treated with a combination of Strattera and buspirone   "
177945|NCT00174239|"     The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in     treating nighttime problems of Parkinson Disease.   "
177946|NCT00174252|"     To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a     child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12     months after initiation of GH treatment.   "
177947|NCT00174265|"     This is an extension study of A7501013 (P05771/NCT00145496) to further test      the efficacy and safety of Asenapine compared with a      marketed agent (olanzapine) in the treatment of patients with      persistent negative symptoms of schizophrenia.   "
177948|NCT00174278|"     To assess the effect of long-term treatment by Genotonorm on linear growth   "
177949|NCT00174291|"     -  To evaluate the effect of increasing the growth hormone dose on the statural response        -  To assess the value of early treatment during the course of arthritic disease by          comparing the height acquired in the medium term by children in the two groups: treated          from the start, or 1 year to 15 months after the diagnosis of CJA, or treated for 4          years after the diagnosis   "
177950|NCT00174304|"     To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage     of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their     governing guidelines.   "
177951|NCT00174317|"     To determine if celecoxib 200 mg once daily is as effective as diclofenac 50 mg three times     daily in the treatment of pain symptoms associated with osteoarthritis of the hip   "
177952|NCT00174330|"     To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .   "
177953|NCT00174343|"     To evaluate clinical and pathologic response rates following primary hormonal therapy by     exemestane (Aromasin®)   "
177954|NCT00174356|"     The main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033     in combination with paclitaxel and carboplatin in patients with NSCLC.   "
177955|NCT00174369|"     MEK is a critical member of the MAPK pathway involved in growth and survival of cancer cells.     PD-325901 is a new drug designed to block this pathway and kill cancer cells. The purpose of     this study is to study the effectiveness of PD-325901 in patients with non-small cell lung     cancer. PD-325901 will be given by mouth as a pill twice a day, CT scans will be done and     biopsies of a tumor and a blood sample will be taken before treatment to examine the how     genes affect tumor response to the study medication. Blood samples will be taken to measure     the amount of drug in the blood.   "
177956|NCT00174382|"     To document effectiveness, safety, and tolerability of donepezil in patients with mixed     AD/VaD, and to further document the effectiveness, safety, and tolerability of donepezil in     patients with VaD. The effects of donepezil on executive functioning, behavior, general     cognition, ADLs and global functioning will be assessed.   "
177967|NCT00174525|"     This research study will assess whether AAB-001 is safe, well tolerated and effective for use     in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside     this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells     to destroy other substances in the body). In Alzheimer's disease a protein called amyloid     gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is     hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to     remove it.   "
177968|NCT00174538|"     The objective of this study is to determine if a subject's genetic make-up would affect the     treatment response to codeine in subjects with sickle cell disease.   "
177969|NCT00174551|"     Investigating the effect of prazosin for nighttime symptoms of civilian Posttraumatic Stress     Disorder.   "
177970|NCT00174564|"     The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy     in patients with advanced biliary tract cancer based on response rate measured by the RECIST     unidimensional criteria.      Secondary objectives are : Progression free survival, overall survival and safety.   "
177971|NCT00174577|"     The purpose of this study is to assess the safety and efficacy of risperidone augmentation in     patients who have failed to respond or only partially responded to an adequate trial of an     antidepressant.   "
177972|NCT00174590|"     The purpose of this study is to determine the safety and efficacy of risperidone monotherapy     in the treatment of psychotic depression. We hypothesize that risperidone is as equally as     effective as haloperidol plus sertraline for depression with psychotic features   "
177973|NCT00174603|"     The purpose of this study is to examine the mood stabilizing and antipsychotic properties of     quetiapine in the treatment of depression by comparing subjects who were randomly assigned to     either quetiapine monotherapy, quetiapine and citalopram; or haloperidol and citalopram. We     hypothesize that quetiapine monotherapy would have similar effects to the combination of a     first generation antipsychotic plus an antidepressant for the treatment of a major depressive     episode with psychosis.   "
177974|NCT00174616|"     Primary objective:        -  Pathological complete response (ypT0N0) rate      Secondary objectives:        -  Histopathological R0 resection rate        -  Pathological downstaging (ypT0-T2N0) rate        -  One month surgical complication rate        -  Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes        -  Safety        -  Local and distant recurrence rates        -  Progression-free survival        -  Overall survival   "
177975|NCT00174629|"     Primary Objective:        -  To compare response rate between genotypic groups and control group.      Secondary Objective:        -  To determine the safety, time to treatment failure and survival in control and genotypic          arms.   "
177976|NCT00174642|"     Primary objectives :        -  To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus          metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm          2) compared with insulin glargine plus metformin combined with 3 bolus of insulin          glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal          insulin therapy with oral antidiabetic drugs.        -  To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus          metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm          2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea          or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively          (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy          with oral antidiabetic drugs.      Secondary objectives :        -  To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of          subjects with HbA1c <= 7% at the end of the study, evolution of blood glucose profiles,          incidence of hypoglycemia, insulin doses, evolution of body weight and treatment          satisfaction.   "
177977|NCT00174655|"     Primary objectives:        -  To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given          either sequentially or in combination with doxorubicin and followed by CMF to          doxorubicin alone or in combination with cyclophosphamide and followed by CMF in          operable breast cancer patients with positive axillary lymph nodes.      Secondary objectives:        -  To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed          by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive          axillary lymph nodes        -  To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin          followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in          operable breast cancer patients with positive axillary lymph nodes        -  To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed          by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast          cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus          polychemotherapy).        -  To compare overall survival of treatment arms.        -  To compare toxicity of treatment arms.        -  To evaluate pathologic and molecular markers for predicting efficacy.        -  Socioeconomic data will be collected in order to be able to perform a socioeconomic          analysis by country, when needed.   "
177978|NCT00174668|"     Primary objective:      The primary study objective is to demonstrate superior efficacy of an intensified insulin     regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin     regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint.      Secondary objectives:      Secondary study objectives are to compare the intensified insulin regimen with insulin     glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of     blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting     plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic     events, adverse events, change of late diabetes complications, weight, body-mass-index,     course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria,     standard lab and quality of life/treatment satisfaction.   "
178010|NCT00175084|"     The aim of this study is to explore the significance of the Lys:Arg ratio on responses of     lipids and lipoprotein concentrations to dietary proteins and to evaluate the effects of     dietary Lys:Arg on cardiovascular disease risk factors and endothelial function.   "
185023|NCT00267969|"     The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab     (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.   "
177979|NCT00174681|"     Primary objective:      The primary objective of this trial is:        -  To evaluate the efficacy of initiating Lantus in combination with oral antidiabetics          drugs compared to oral antidiabetic treatment optimised by enhancing hygienic and          dietary measures in type 2 diabetics whose blood glucose control is acceptable but not          optimal on maximum oral treatment, based on the number of patients achieving a HbA1c          value < 7% at the end of treatment.      Secondary objectives:      The secondary objectives of this trial are to compare between the two treatment groups:        -  The variation in HbA1c between baseline and end of trial.        -  The frequency of episodes of symptomatic hypoglycaemia (diurnal and nocturnal), severe          hypoglycaemia (diurnal and nocturnal) and asymptomatic hypoglycaemia.        -  Mean blood glucose levels at different times of the day.        -  The variation in weight and lipid in each group between baseline and end of trial.        -  The incidence of adverse events.   "
177980|NCT00174694|"     Primary objective:        -  To demonstrate that the clinical efficacy of telithromycin (800 mg od for 5 days) is          non-inferior to amoxicillin-clavulanic acid (875/125 mg bid for 10 days) at the          test-of-cure (TOC) visit (Day 17-21) in subjects with acute bacterial sinusitis (ABS).      Secondary objective(s):        -  To assess the time to resolution of signs and symptoms between the baseline (Day 1) and          TOC (Day 17-21) visits,        -  To assess the rate of clinical relapse at the follow-up visit (Day 41-49),        -  To assess health economic outcome until follow-up visit (Day 41-49),        -  To assess quality of life up to the follow-up visit (Day 41-49),        -  To compare the safety of telithromycin and amoxicillin-clavulanic acid,        -  To compare the bacteriologic outcome of both treatments as observed at TOC (Day 17-21)          and at follow-up visit (Day 41-49),in subjects with ABS.   "
177981|NCT00174707|"     Primary objectives:        -  To compare the disease free survival (DFS) in patients treated with the sequential          epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that          in patients treated with the same treatment plus docetaxel given sequentially after          epidoxorubicin      Secondary objectives:        -  To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and          CMF (only patients with > or = 4 lymph nodes) regimen to that in patients treated with          sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen        -  To evaluate the overall survival in each arm        -  To evaluate the tolerability of a sequential intensified          epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)        -  To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen          versus a standard sequential epidoxorubicin/CMF regimen (arm A)   "
177982|NCT00174720|"     To investigate the efficacy of ciclesonide MDI either as once daily or twice daily in     patients with mild to moderate asthma, who have not previously been treated with an inhaled     corticosteroid.   "
177983|NCT00174733|"     To investigate the efficacy of ciclesonide MDI either as once daily or a twice daily regimen     in patients with mild to moderate asthma, who have previously been treated with an inhaled     corticosteroid.   "
177984|NCT00174746|"     To investigate the efficacy and safety of ciclesonide inhaled into the lungs in a range of     doses in a new dry powder inhaler compared to ciclesonide inhaled into the lungs using a     metered dose inhaler   "
177985|NCT00174759|"     Primary objective:      To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100     mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in     patients receiving a below knee bypass graft for the treatment of PAD.      Secondary objectives:      Comparison, between the two treatment groups, of :        -  Primary patency,        -  Assisted primary patency,        -  Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle.        -  Ankle Brachial Pressure Index (ABPI) changes from baseline   "
177986|NCT00174772|"     Primary Objective:        -  To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy          followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by          consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC          (stage IIIA- multiple cN2 or IIIB).      Secondary Objective:        -  To estimate efficacy parameters in overall response rate, progression free survival and          1 year survival for each of the two above mentioned arms.   "
177987|NCT00174785|"     To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death     from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter     (AF/AFL).      To assess that dronedarone is well tolerated in this population.   "
177988|NCT00174798|"     To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric     parameters in patients with OAB and UUI.   "
177989|NCT00174811|"     The clinical activity of telithromycin vs. cefuroxime in children with acute infections of     the middle ear, ages 6 months to 59 months old will be studied.   "
177990|NCT00174824|"     To compare the progression of diabetic retinopathy in type 2 diabetic patients with     mild-to-moderate diabetic retinopathy treated with insulin glargine vs NPH human insulin.   "
177991|NCT00174837|"     The trial will compare the efficacy and safety of concomitant chemoradiation with     tirapazamine, cisplatin and radiation versus cisplatin and radiation.   "
178005|NCT00175019|"     The purpose of this study is to determine the long-term safety of febuxostat, once daily     (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.   "
178006|NCT00175032|"     The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal     complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between     lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in     participants with osteoarthritis taking low dose aspirin.   "
178007|NCT00175045|"     The purpose of this study was to compare the pharmacodynamics of intravenous (IV)     lansoprazole to oral lansoprazole capsules, once daily (QD), in participants with erosive     esophagitis.   "
178008|NCT00175058|"     To determine whether or not HyperOxemic therapy rendered to patients (that meet the study     inclusion criteria) with anterior acute myocardial infarction < 6 hours from symptom onset to     reperfusion, results in a significant reduction in infarct size as measured by SPECT @ 14     days post event.   "
178009|NCT00175071|"     The current study is designed to assess the effect of a conventional cooking oil     (hydrogenated oil) and a reformulated fat low in trans fatty acids on cardiovascular disease     risk factors.   "
177992|NCT00174850|"     Anxious patients are now treated with Selective Serotonin Reuptake Inhibitor medications     (common antidepressants) which elevate serotonin and thus alleviate anxiety. These     medications have clearly proven efficacy upwards of 70% for many anxiety disorders. In     regards to tolerability, they have a major problem in that they often produce sexual     dysfunction in men and women (ie. decreased libido, anorgasmia, impotence) upwards of 30% of     the time.      Benzodiazepine anxiolytics are also FDA approved to treat anxiety with equal efficacy and     greater tolerability (very little, if any sexual dysfunction). They do, however, carry a     substantial risk for addiction. Tiagabine is a Selective GABA Reuptake Inhibitor (SGRI) that     is FDA approved to treat certain types of epilepsy. Like benzodiazepines, Tiagabine also     increases the neurotransmitter, GABA, in the brain and is thought to alleviate anxiety (see     references below) this way too, but without any addiction risk common to Valium-type drugs.     The safety profile of Tiagabine is thought to be much safer. Two double blind studies are     ongoing which are looking at Tiagabine's effectiveness in PTSD and GAD. There are many open     label studies showing anxiety reduction and many psychiatrists in clinical practice are     utilizing this agent as an anxiety treatment in an off-label manner.      This study is designed to evaluate anxious patients who are taking SSRI medication, have had     a reasonable response, but are experiencing significant sexual side effects which are pushing     them towards noncompliance and possible relapse into anxiety. 30 subjects (15 men and 15     women) will be asked to join the study and be placed on Tiagabine as well as their current     SSRI. Once an acceptable dose of Tiagabine is reached in the first four weeks, the subjects'     SSRIs will be slowly stopped. Two weeks after enrollment, all subjects will be called in     order to check for any side effects to the study drug and to insure that each subject is     titrating to the proper dose of study drug according to the study protocol. An open-label,     non-placebo prospective 10 week follow up will occur, where the now Tiagabine monotherapy     subjects will be followed to see primarily if their sexual dysfunction improves and if there     anxiety remains controlled.   "
177993|NCT00174863|"     To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen     prostate cancer patient without distant metastases with Time to Clinical progression as main     objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms     deterioration Quality of Life, PK analysis as secondary objectives   "
177994|NCT00174876|"     A sizeable minority of patients suffering from major depression do not have their full set of     depressive symptoms relieved by a single medication. Often times, a second medication is     added to a patient's first antidepressant to obtain a better response in hopes of getting the     depressed patient into full remission from symptoms.      A typical psychiatric approach of recent has been to add one of the newer anti-schizophrenia     medications to an existing FDA approved antidepressant in order to achieve better serotonin     levels in the depressed patient's brain. This optimization of brain serotonin helps to     alleviate more depressive symptoms. The newest antipsychotic medication to be FDA approved is     Aripiprazole (Abilify). It may be particularly effective as it may safely elevate sertotonin     through receptor 1a stimulation, receptor 2a blockade. It may also facilitate low levels of     dopamine transmission which is truly novel for this agent when compared to other     schizophrenia drugs. Depressed patients also tend to lack dopamine in their brains. This     makes Aripiprazole and ideal agent to boost both serotonin and dopamine simultaneously. In     theory, this may be an effective way to alleviate more depressive symptoms.      The author suggests to enroll 10 subjects initially in open label fashion to take     Aripiprazole plus their current FDA approved antidepressant to see if further elimination of     depressive symptoms occurs and to show this pharmacological approach as a tolerable     combination of medications. If there are no major safety issues, an amendment to allow 10     additional subjects will be forwarded to provide a better tolerability sample size.   "
177995|NCT00174889|"     Pregnenolone is a neurosteroid and possesses intrinsic behavioral and brain effects in     animals, affecting the GABA(A) and other receptors. Pregnenolone is serves as the precursor     for dehydroepiandrosterone (DHEA) and its sulfate ester (DHEAS). There is evidence of     efficacy of DHEA augmentation in schizophrenia, we therefore sought to examine the efficacy     of augmentation of antipsychotic treatment of schizophrenia patients with pregnenolone. It is     hypothesized that the combined effect of antipsychotic agents and pregnenolone would be     beneficial in the treatment of negative,depressive, and cognitive symptoms.   "
177996|NCT00174902|"     This randomized double-blinded controlled trial uses a factorial design to investigate     whether application of beta-blockers (inderal 80 mg) or aspirin (100 mg) or a combination     thereof has an effect on the activation of the hemostatic system, the platelets and the     endothelium in response to acute mental stress. Specifically we test the hypothesis that     inderal attenuates the activation of the hemostatic system as compared to placebo. The second     hypothesis is that aspirin attenuates the activation of platelets as compared to placebo.     Subjects will be randomly allocated to either of the four following study arms: placebo -     inderal - aspirin - inderal plus aspirin. Subjects will receive the study medication for five     days prior to the mental stress. The acute mental stress consists of a public speaking     session of 10 min duration immediately followed by a mental arithmetic test of 5 min     duration. Blood will be collected prior to the stress, immediately thereafter, at 45 min at     at 1 hour and 45 min.   "
177997|NCT00174915|"     The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD),     in subjects with gout.   "
177998|NCT00174928|"     The purpose of this study is to understand how quickly lansoprazole, once daily (QD),     improves feeding in premature babies or babies less than 28 days of age.   "
177999|NCT00174941|"     The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD),     in maintaining serum urate levels within clinically acceptable levels in subjects with gout.   "
178000|NCT00174954|"     The purpose of this study is to determine the reproducibility of Magnetic Resonance Imaging     (MRI) in the quantitative assessment of tophus volume.   "
178001|NCT00174967|"     The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in     reducing serum urate levels in subjects with gout.   "
178002|NCT00174980|"     Brain damage as a result of decreased oxygen to the brain is found in 80% of patients that     die with severe head injuries. Laboratory studies in animals and clinical trials have shown     that increasing oxygen in the brain results in better brain oxygen consumption, less cell     death, and better functional outcome. This study will test the hypothesis that Oxycyte is an     effective way to increase brain oxygen levels in severe head injury.   "
178003|NCT00174993|"     The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay     the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg     bypass surgery or amputation in patients with type 2 diabetes.   "
178004|NCT00175006|"     The purpose of this study is to determine the inter- and intra-rater reproducibility of     direct physical measurement of tophus nodules in subjects with gout.   "
178011|NCT00175097|"     To evaluate the impact of soybean processing as well as the effect of soy relative to animal     protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors     in hypercholesterolemic subjects.   "
178012|NCT00175110|"     The goal of this study is to find out whether the plant compounds present in Hibiscus     sabdariffa, a plant commonly used in herbal tea blends and other beverages, will have a     beneficial effect on blood pressure in people with mildly elevated blood pressure.   "
178013|NCT00175123|"     The purpose of this study is to examine how injection of botulinum toxin in the bladder     affects bladder function. The trial is carried out in children born with malformation of the     spinal cord and subsequent overactive bladders. The purpose of treating the bladder (with     different drugs) is to prevent damage to the kidneys and renal function. The aim of this     study is to compare a conventionally used drug (oxybutynin) with botulinum toxin. The     hypothesis of the study is that botulinum toxin is equal to oxybutynin in the treatment of     overactive bladder.   "
178014|NCT00175136|"     The purpose of this study is to compare the early migration and periprosthetic bone changes     of two cemented total knee arthroplasties with different tibial stem design. Only the tibial     prostheses plateau varies in that one is an wedge-shaped stem and the other is a I-shaped     stem.   "
178015|NCT00175149|"     Left ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of     LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH. In     the present study patients are randomised to 1.25 dihydroxycholecalciferol or no treatment to     study the effect on LVH.   "
178016|NCT00175162|"     The purpose of this study is to compare the early migration and periprosthetic bone changes     of two total knee arthroplasties fixated with two different type bone cement.   "
178017|NCT00175175|"     Patients with hip fractures have suffered the most devastating consequence of osteoporosis;     and yet, they are rarely if ever tested or treated for the condition, even though they remain     at high risk of recurrent fracture.      We hypothesize that, compared with usual care, an allied health professional-run osteoporosis     service (case management) will be able to increase testing and treatment of osteoporosis in     patients at high risk of fracture.   "
178018|NCT00175188|"     The purpose of this study is to compare the early migration and the periprosthetic bone     changes of cemented versus non-cemented interphalangeal implants using Roentgen     stereophotogrammetric analysis and dual energy x-ray absorptiometry (DEXA). Furthermore, a     thorough occupational therapist evaluation on the functional progress prior to and after     surgery will be assessed.   "
178019|NCT00175201|"     In this randomised study a proactive care and rehabilitation intervention is compared to the     current care and rehabilitation in patients undergoing primary hip and knee replacement     surgery.      A cost efficacy analysis in a societal perspective is made from effect data in the randomised     controlled study together with cost data gathered during the perioperative and postoperative     period.      If the proactive care and rehabilitation intervention is cost effective the intervention is     going to be implemented in Ringkøbing County. This implementation proces is measured within a     monitoring project of all patients receiving hip or knee replacement surgery in Ringkøbing     County in the period 2003 to 2007.   "
178020|NCT00175214|"     The primary objective of this proposed research is to improve the quality of care for     patients who present to the Emergency Department with osteoporosis and a fracture of the     wrist, by increasing the use of proven efficacious osteoporosis treatment. This is the     primary study outcome, and it is defined as starting any one of hormone therapy, a     bisphosphonate, raloxifene, or calcitonin within 6 months of a fracture of the wrist.      The study hypothesis is that a quality improvement intervention (with multiple components     that include a notification system for primary care physicians, patient-specific reminders,     locally generated treatment guidelines endorsed by opinion leaders, and patient education and     counseling) will lead to increased use of proven efficacious osteoporosis treatments in     patients eligible for secondary prevention. This hypothesis will be tested by comparing the     intervention with usual care controls, in a prospective nonrandomized controlled trial.   "
178021|NCT00175227|"     Patients with pre-existing kidney disease are at high risk of acute renal failure when     exposed to radio-contrast dyes, for example during a cardiac angiogram.      The investigators hypothesize that an infusion of saline + furosemide + mannitol will reduce     rates of contrast-induced nephropathy when compared with saline infusion controls.   "
178022|NCT00175240|"     People with coronary artery disease can reduce their chance of having a heart attack by     making healthy lifestyle choices (diet, exercise, quitting smoking,etc.). There are also many     medications that have been proven to reduce the risk of heart attacks and may even help     people live longer. This study will look at different ways of improving the use of these     beneficial medications to enhance the quality of care for people with this condition.   "
178023|NCT00175253|"     Our experience suggests that further research with alemtuzumab is attractive in islet     transplantation. Therefore, in this study we propose to combine alemtuzumab induction     pre-transplant, with tacrolimus and mycophenolate mofetil maintenance immunosuppression     post-transplant. In the critical early phase post transplant, we anticipate that this regimen     will prove to be more effective in control of autoimmunity or rejection events, and have a     more desirable side-effect profile, than previously tested combinations of induction and     immunosuppressive agents.   "
178024|NCT00175266|"     Islet transplantation has been investigated as a treatment for Type 1 diabetes mellitus in     selected patients with inadequate glucose control despite insulin therapy. However, the     perennial hope that such an approach would result in long-term freedom from the need for     exogenous insulin, with stabilization of the secondary complications of diabetes, has failed     to materialize in practice. The goal of the present study is therefore to improve the safety     and efficacy of clinical islet-alone transplantation by minimizing dependence on     calcineurin-inhibitor therapy - thereby avoiding potential nephrotoxicity, and furthermore     improving success with single-donor islet infusions by avoiding all diabetogenic     immunosuppression. Campath-1H, combined with Infliximab induction therapy provides a unique     opportunity to minimize dosing of maintenance long-term immunosuppression while further     promoting islet engraftment.   "
178434|NCT00179218|"     The objective of this study is to determine how protein supplementation, with or without     exercise, affects functional capacity, strength, body composition, and physical activity in     hemodialysis patients.   "
178025|NCT00175279|"     BACKGROUND: Although much has been written about the influence of local opinion leaders on     clinical practice, there have been few controlled studies of their effect, and almost none     have attempted to change prescribing in the community for chronic conditions such as     congestive heart failure (CHF) or ischemic heart disease (IHD). These two conditions are     common and there is very good evidence about how to best prevent morbidity and mortality -     and very good evidence that quality of care is, in general, suboptimal. Practice audits have     demonstrated that about half of eligible CHF patients are prescribed ACE inhibitors (and     fewer still reaching appropriate target doses) and less than one-third of patients with     established IHD are prescribed statins (with many fewer reaching recommended cholesterol     targets). It is apparent that interventions to improve quality of prescribing are urgently     needed.      HYPOTHESIS: An intervention that consists of patient-specific one-page evidence summaries,     generated and then endorsed by local opinion leaders, will be able to change prescribing     practices of community-based primary care physicians.      DESIGN: A single centre randomized controlled trial comparing an opinion leader intervention     to usual care. Based on random allocation of all physicians in one large Canadian health     region, patients with CHF or IHD (not receiving ACE inhibitors or statins, respectively)     recruited from community pharmacies will be allocated to intervention or usual care. The     primary outcome is improvement in prescription of proven efficacious therapies for CHF (ACE     inhibitors) or IHD (statins) within 6 months of the intervention.   "
178026|NCT00175292|"     This randomized placebo-controlled double-blind, multi-centre trial will determine the     efficacy of the probiotic VSL#3 in the prevention of Crohn's disease development following     surgical resection and re-anastomosis. A total of 120 patients will be randomly assigned in a     1:1 ratio to receive VSL#3 or placebo for 90 days. Patients who respond to study treatment,     as defined by the absence of a severe endoscopic recurrence at day 90, will be offered     open-label VSL#3 for an additional 9 months.   "
178027|NCT00175305|"     Excessive weight gain is a cardinal feature of Prader-Willi syndrome (PWS) for which there is     presently no effective treatment. It is caused by increased appetite, decreased perception of     satiety and obsessive and compulsive behaviour towards food. Ghrelin is a powerful     appetite-stimulating hormone. Patients with PWS have markedly elevated ghrelin levels,     suggesting that it may be responsible for the increased food intake. The goal of the study is     to determine whether treatment with somatostatin (Sandostatin), a hormone that inhibits     ghrelin, is an effective treatment for the prevention and treatment of weight excess in     patients with PWS.   "
178028|NCT00175318|"     Dental decay is an alarming problem in Cree children. The intervention is a behavioural     counseling approach called Motivational Interviewing (MI). The dental health of young     children in communities whose mothers had a series of MI sessions provided by Cree women will     be compared to the dental health of mothers who did not have the intervention.   "
178029|NCT00175344|"     All patients undergoing breast cancer surgery are left with scars which can significantly     affect their physical and psychological well being. Patients with breast cancer, motivated to     optimize healing and function, have inquired about the advisability of scar massage after     surgery. Although this is a popular technique advocated by physiotherapists and massage     therapists to improve pain, range of motion, and scar pliability, there is currently no     scientific research to prove the benefits and/or risks of scar massage in breast cancer     patients. We propose to study the effect of scar massage on pain, arm function, scar     formation, and quality of life in patients with breast cancer. Patients who have had breast     cancer surgery and who have been referred to the BC Cancer Agency, Vancouver Island Centre     will be offered participation in this research study. To objectively evaluate the effects of     scar massage, those who agree to participate will be randomly assigned to one of two groups.     One group will be taught to perform self-massage of the scars as soon as the scars have     adequately healed. The massage should be done about 10 minutes each day for a total of 6     months. The other group will not be taught self-massage and will be asked to not massage     their breast scars. In both groups, we will monitor pain, upper body range of motion, scar     characteristics and quality of life using standardized criteria for 2 years from the time of     surgery. Problems with infections or blood or fluid accumulation at the scar areas will also     be monitored. After 2 years, the information collected will be analyzed and compared to see     if there are differences in pain, function or quality of life between the two groups. The     results from this study will provide scientific proof of whether or not scar massage after     surgery is beneficial for patients with breast cancer.   "
178030|NCT00175357|"     The objective of this study is to determine whether the closely supervised provision of     injectable, pharmaceutical-grade heroin (in combination with oral methadone) is more     effective than methadone therapy alone in recruiting, retaining, and benefiting long-term     heroin users who have not been helped by current standard treatment options.   "
178031|NCT00175370|"     Patients admitted into the Intensive Care Unit (ICU) have an intravenous (IV) catheter (small     plastic tube) placed in their vein. Very occasionally (4 times out of 100) the insertion of     an intravenous catheter may cause an infection in the blood. It has been shown that the     removal of the catheter and the insertion of a new one at a new site helps to get rid of this     infection. Sometimes, antibiotics are also given.      Vancomycin is the antibiotic given intravenously (into the vein) to treat these     catheter-related infections. At Vancouver General Hospital, some physicians may not give any     vancomycin at all whereas others may treat with intravenous (IV) vancomycin for one to     fourteen days.      Since there are a lack of data to support the length of IV vancomycin therapy, the     investigators would like to find out if two days of IV vancomycin are as good as seven days.      Therefore, the purpose of this study is to determine if two days of IV vancomycin are as good     as seven days for the treatment of catheter-related infections in the blood.   "
178032|NCT00175383|"     Brachytherapy, or Transperineal implantation of the prostate (TPIP), is a recognized form of     treatment for localized cancer of the prostate. TPIP has been used at the British Columbia     Cancer Agency (BCCA) since 1998. As part of the treatment, some patients also require hormone     therapy for 6 months. This is given as injections of a drug called an LHRH agonist. The LHRH     agonist is made either as short-acting (1-month) or long-acting (3 month) injections. The     LHRH agonist lowers testosterone levels, which helps make delivery of TPIP easier, and more     effective.      There are specific guidelines regarding the use of LHRH agonist treatment with brachytherapy,     however there is no policy whether short-acting or long-acting LHRH agonists should be used.      Analysis of results from BC has shown that there seems to be a delay in the time in which     testosterone levels return to normal in men who receive the long-acting LHRH agonist compared     with the short-acting LHRH agonist, however this is not known for sure.   "
178051|NCT00175630|"     This study evaluates the effect of a femoral nerve block on opioid requirements following     anterior cruciate ligament (ACL) reconstruction. This is a double blind, prospective     randomized controlled trial.   "
178391|NCT00178646|"     The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating     muscle tightness and spasms in the feet and ankles of people with stroke.   "
178033|NCT00175396|"     The purpose of this trial is to compare two similar treatments for patients diagnosed with     prostate cancer. The two treatment arms being compared are: (Standard Arm) hormone therapy,     which will prevent the production of the male hormone, testosterone, by the testicles, and     pelvic external beam radiation therapy (EBRT) followed by a high-dose, conformal EBRT boost     versus (Investigational Arm) hormone therapy and pelvic EBRT followed by a brachytherapy     boost (implantation of radioactive iodine sources or seeds into the prostate).      The hypothesis of this trial is that more patients may experience 5 year actuarial freedom     from biochemical recurrence of their prostate cancer following treatment with the     investigational arm. Biochemical failure is declared on the date when the post treatment     prostate specific antigen (PSA) is > 2 ng/mL above the lowest level previously recorded.   "
178034|NCT00175409|"     The purpose of this study is to compare the effects of mothers' breastfeeding with the     effects of pacifier sucking on preterm infant biobehavioural responses during and immediately     after a painful procedure      Hypothesis:        1. When breast fed by their mothers during blood collection, preterm infants will show less          pain reaction than when sucking on a pacifier.        2. Following breast feeding during the blood collection, mothers will find no differences          in their infants' breast feeding ability.   "
178035|NCT00175422|"     This research project seeks to implement an early intervention program that can be effective     in the prevention of shaken baby syndrome (SBS) and infant abuse. The investigators'     hypothesis is that the Period of PURPLE Crying intervention program can be effective in     reducing the shaking and abuse of infants through changes in knowledge, attitudes and     behaviours about early infant crying, especially inconsolable crying.   "
178036|NCT00175435|"     This study will look at what happens to the level of protection against hepatitis B (HB)     disease if a 'helper' gel is applied to the skin over the injection site of a small dose of     hepatitis B vaccine.   "
178037|NCT00175448|"     A Randomized Controlled Trial of Outpatient Physiotherapy versus a Self-Administered Home     Exercise Program Following Discharge Home from Total Hip Arthroplasty   "
178038|NCT00175461|"     Comparison of the clinical effectiveness and cost-effectiveness of the MIS anterolateral     approach (MIS Watson Jones, G3) versus anterolateral mini or posterolateral mini approaches     in primary total hip arthroplasty   "
178039|NCT00175474|"     Comparison of a minimally invasive technique for total knee replacement to a standard     technique   "
178040|NCT00175487|"     This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip     system. This is a prospective randomized trial.   "
178041|NCT00175500|"     About ten percent of revision hip replacements will dislocate. Although dislocation is not a     life-threatening problem, it is stressful and costly and requires hospitalization to treat.     Subjects who have repeated dislocations live with the constant fear of another dislocation.     The purpose of this study is to test the effectiveness of a large ball prosthesis in     preventing post-surgical dislocation. A large diameter ball has greater freedom of movement     before it impinges; therefore, theoretically, it should not dislocate as easily.   "
178042|NCT00175513|"     This is an 18 week (2 weeks run-in, 16 weeks double blind) trial, to determine if an     antiviral drug, valacyclovir (Valtrex) is helpful in treating the symptoms of psychosis, a     form of a mental disorder.   "
178043|NCT00175526|"     At present, the management of pre-eclampsia is guided by expert opinions that are not     well-based on firm evidence. What is required is a clinical tool that can accurately     determine a women's risk for adverse outcomes, and thereby reduce the risk for women while     safely prolonging pregnancies remote from term (to improve fetal outcomes). This research     project, 'a severity score for pre-eclampsia,' will develop such a clinical tool that is     specific to the condition. This severity score will be used clinically (to guide management)     and in research (in both clinical trials and basic science research), and will provide an     evidence base on which to build future practice, improving outcomes for pregnant women and     their babies. In addition, this project is part of a three part strategy to better understand     the mechanisms of disease in pre-eclampsia and to investigate a potential disease-modifying     therapy, namely, recombinant human activated protein C.   "
178044|NCT00175539|"     The purpose of this study is to pilot test and determine the feasibility of a     psychoeducational intervention (PED) we recently developed in a group format for women with     acquired sexual arousal disorder (FSAD).      HYPOTHESES:        -  1 - Compared to baseline measures, the PED will result in significant improvement in          self-report measures of: (a) subjective sexual arousal; (b) perception of genital          arousal/genital sensitivity; (c) orgasmic experience; (d) sexual desire; (e) sexual          distress; (f) relationship satisfaction; (g) depressive symptoms; and (h) quality of          life.        -  2 - It is unknown what effect the PED will have on actual physiological sexual arousal.        -  3 - The group format will be a feasible and cost-effective method of delivering          empirically supported treatment to women with sexual arousal difficulties and will          contribute towards meeting the needs for sexual health care for women on the clinic          wait-list at the BC Centre for Sexual Medicine.   "
178045|NCT00175552|"     Evaluating the Effectiveness of Different Interpersonal Psychotherapy for Adolescents (IPT-A)     Therapist Training Models   "
178046|NCT00175565|"     Systemic inflammation is present in chronic obstructive pulmonary disease (COPD), which has     been linked to cardiovascular morbidity and mortality. We determined the effects of oral and     inhaled corticosteroids on serum markers of inflammation in patients with stable COPD.   "
178047|NCT00175578|"     Promising new technology exists to examine small proteins that are shed by cancers into the     blood stream. The purpose of this study is to see if there are differences in the proteins     and protein levels in blood from individuals with early stage lung cancer compared to healthy     adults.   "
178048|NCT00175591|"     This study evaluates the effect of a femoral nerve block on opioid requirements following     femoral fracture fixation with flexible nails in the paediatric population. This is a double     blind, prospective randomized clinical trial.   "
178049|NCT00175604|"     The primary purpose is to investigate the effect of Botox on the treatment of congenital     muscular torticollis (CMT). The investigators' hypothesis is that a Botox injection will be     an effective treatment when used in conjunction with current treatment procedures.   "
178050|NCT00175617|"     This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared     to topical minoxidil in female pattern hair loss.   "
178052|NCT00175643|"     It is believed that imiquimod 5% cream has the potential to be an effective treatment for     actinic keratoses. The purpose of this study is to evaluate the duration of the effect of     topical imiquimod 5% topical cream for the treatment of actinic keratoses.   "
178053|NCT00175656|"     Titanium elastic nails in the pediatric femoral fractures: A prospective randomized clinical     trial of eliminating nail protrusion to decrease soft tissue complications   "
178054|NCT00175669|"     The purpose of this study is to compare the effect of Botox and casting to placebo and     casting for reducing toe walking problems in children who are idiopathic toe walkers.   "
178055|NCT00175682|"     Sexuality is a high rehabilitative priority for persons following a spinal cord injury (SCI).     Sexual acts can lead to autonomic dysreflexia (AD), dangerous consequences such as a sudden     increase in blood pressure, severe headache, sweating above the level of the lesion and low     heart rate to name a few. Ejaculation in men can provoke these significant symptoms and     therefore men and women may refrain from a sexual life and biological parenthood. Adalat is     the most common antihypertensive used in fertility clinics to reduce the incidence of AD. It     dramatically reduces blood pressure and, therefore, results in side effects such as     dizziness, fatigue and weakness. The investigators hypothesize that Minipress® (prazosin     HCL), a blood pressure medication, which has a slower and less abrupt suppressive effect on     blood pressure, would be a safe, effective and more appropriate medication for use in the     outpatient sperm retrieval clinic and potentially for private use.   "
178056|NCT00175695|"     Short description of the primary purpose of the protocol intended for the lay public. Include     brief statement of study hypothesis      Pre-eclampsia (toxemia of pregnancy) is the most cause of death among pregnant women in North     America. It also causes many complications for fetuses (unborn children) and neonates     (newborn children). Pre-eclampsia is defined by high blood pressure (hypertension), the loss     of protein into the urine (proteinuria), and disorders of many body systems, including the     blood clotting (coagulation) and inflammation. What is needed is a compound that will safely     prolong pregnancies, to give babies more time to grow inside their mothers, and will help the     recovery in those mothers after delivery.      We are going to investigate a compound (recombinant human activated protein C (rhAPC)) that     has the potential to modify disease activity in pre-eclampsia by reducing coagulation and     inflammation disorders. rhAPC is effective in patients suffering from septic shock. We will     test rhAPC in women who develop severe pre-eclampsia in two ways. First, in women with severe     pre-eclampsia remote from term who are carrying small babies (intent: safely prolong their     pregnancies). Second, in women who have had severe pre-eclampsia before their baby delivered     (including women in the first group), or whose disease develops/worsens after delivery     (intent: switch off the disease so dangerous complications do not arise).      This study is a preliminary one to look for possible risks and benefits for these women. Only     40 women will be studied to provide initial evidence on which to base a larger international     trial which is planned. We will study their pregnancy outcomes as well as markers of disease     activity, to gain a better understanding of the mechanisms by which these women become     unwell.   "
178057|NCT00175708|"     The purpose of this study is to determine the utility of pedobarographs in evaluating     clubfoot post-treatment.   "
178058|NCT00175721|"     The purpose of this study is to assess the benefits of a combined cardiac, kidney, and     diabetes clinic versus multiple clinics.      Hypothesis: Attendance at multiple clinics by one individual patient has multiple problems     which may be overcome by the introduction of a combined care clinic.   "
178059|NCT00175734|"     The purpose of this study is to document relevant and related clinical changes associated     with different hemoglobin concentrations in diabetic hemodialysis patients.      Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin     concentrations in diabetic hemodialysis patients.   "
178060|NCT00175747|"     Studies in animals suggest that inhaled budesonide may prevent the occurrence of lung cancer.     We conducted a clinical trial to determine the effects of inhaled budesonide in smokers who     had precancerous lesions in the breathing tubes (i.e. bronchial dysplasia.   "
178061|NCT00175760|"     This study is to see if a high response to the TTG screening test for celiac disease is as     accurate as the current method of diagnosing celiac disease which entails a general     anesthetic and upper endoscopy to obtain biopsies of the small intestine. If the screening     blood test is highly accurate, then some patients that are being evaluated for celiac disease     may not require an upper GI endoscopy and can be treated more quickly. If they respond to the     therapy then they will be deemed to have celiac disease.   "
178062|NCT00175773|"     The primary purpose of this study is to investigate the relationship between the extent of     neurologic (nerve) impairment in patients with spinal cord injuries and how well the nerves     passing down the spine to the heart and blood vessels are working. These nerves are called     the descending spinal sympathetic pathway (DSSP) and are important in controlling many     functions, including blood pressure. We also wish to examine how injury severity and DSSP     function influence blood levels of nor-epinephrine and epinephrine. Nor-epinephrine and     epinephrine are hormones released into the blood that are also important in controlling blood     pressure. Thus, we will also look at how the effect of the extent of DSSP dysfunction     influences heart rate and blood pressure and blood levels of certain enzymes.   "
178063|NCT00175786|"     The purpose of this study is to study the occurrence rate of masses such as brain tumors in     patients with newly diagnosed Normal Tension Glaucoma.   "
178064|NCT00175799|"     This is a study of the validation of severity of illness scoring systems in Paediatric     Intensive Care Units (PICUs) in Canada.   "
178065|NCT00175812|"     Hypothesis: Differentiation induction therapy in acute myelogenous leukemia (AML) can be used     to achieve disease control and stabilize peripheral blood counts in patients with acute     myelogenous leukemia.      Adult patients (<18 years of age) who can be included: Elderly patients (>60 years of age)     with newly diagnosed AML who cannot achieve standard chemotherapy, patients with relapsed or     resistant AML. Patients with relapsed or resistant AML who cannot receive intensive     chemotherapy.      Treatment: Patients will be treated with all-trans retinoic acid (oral administration),     valproic acid (7 days intravenous administration and later oral administration)and     theophyllamine (7 days intravenous administration and later oral administration). Duration of     treatment at least 2 months or until disease progression. Maximal duration of treatment 2     years.      Followup: Clinical evaluation, peripheral blood samples, bone marrow samples.   "
178071|NCT00175890|"     To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in     pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects     will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an     evaluation). Other neuropsychological clinical assessments will be performed during the 34     day length of the study.   "
178072|NCT00175903|"     Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam     (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release     (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with     newly diagnosed epilepsy.   "
178074|NCT00175929|"     This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150     mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy   "
178075|NCT00175942|"     Sudden cardiac death is in most cases triggered by ischemia-related ventricular     tachyarrhythmias and accounts for 50% of deaths from cardiovascular disease in developed     countries. Chronic elevation of indicators of coagulation activation has been found in     patients with coronary heart disease , but a role of coagulation activation and     proinflammatory state as a potential risk factor for ventricular fibrillation (VF) during     acute myocardial infarction has not been investigated.   "
178076|NCT00175955|"     An 8-week study to examine safety and efficacy of levetiracetam in patients with     neuroleptic-induced tardive dyskinesia   "
178077|NCT00175968|"     Aim of the study is to assess the impact of the factors ´bed rest´ and ´hypocaloric     nutrition´ on endothelium-dependent vasoreactivity in healthy volunteers.   "
178078|NCT00175981|"     Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its     effect on the venous response to sodium nitroprusside.   "
178079|NCT00175994|"     The purposes of this study are:        -  To determine the absolute bioavailability of voriconazole after a single oral dose (400          mg voriconazole [VFEND brand]) in comparison to intravenous (i.v.) administration (400          mg VFEND, equivalent to two 10 mg/ml-infusates, each containing 200 mg voriconazole          [VRC]) in healthy individuals stratified according to the three predominant CYP2C19          genotypes        -  To investigate the possible pathways of metabolism and their modulation according to          genetic polymorphism of CYP2C19 after i.v. and oral administration of VRC.   "
178080|NCT00176007|"     Aim of the study is to investigate the function of the systemic vascular endothelium in     individuals susceptible to high-altitude pulmonary oedema during normoxia and normobaric     hypoxia.   "
178081|NCT00176020|"     The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment,     3-­way crossover. Subjects will be randomly allocated to a treatment sequence – AAB, ABA or     BAA. The two treatments will be:        -  Treatment A: 500 mg nicotinic acid (Niacor(R))        -  Treatment B: Niacor(R) Placebo      Each trial period will last one day, there will be a wash-out period of at least 2 days     between each trial period. Five to seven days after study day 1 of trial period 3 there will     be a final safety examination.   "
178082|NCT00176033|"     The aim of this study is to determine the pharmacokinetics of Kaletra™ (HIV protease     inhibitors lopinavir and ritonavir) in different body compartments and to assess the role of     four different drug transporters (MDR, MRP1, MRP2 and BCRP) in the tissue distribution of the     two protease inhibitors. The latter will be studied by comparing intracellular concentrations     of peripheral blood mononuclear cells (PBMCs) with total and free plasma concentrations in     healthy individuals. These effects will be studied after single dose (day 1), during steady     state (day 3), and during chronic treatment (day 14).   "
178083|NCT00176046|"     The purpose of this feasibility study is to identify appropriate surrogate parameters for a     randomized study to examine the efficacy of a complementary therapy with an extract of viscum     album (Iscador P) in patients with breast cancer.   "
178084|NCT00176059|"     The aim of this randomized prospective study in renal transplant recipients is to investigate     immunological short and long-term effects of an IVIG induction therapy.      Furthermore clinical endpoints (patient and graft survival, incidence of acute and chronic     rejection, infectious diseases and graft function) up to three years posttransplant will be     analyzed.   "
178085|NCT00176072|"     Bioavailability of methylene blue (MB) - comparison of an i.v. and two oral MB formulations -     and influence of sustained release MB on chloroquine (CQ) concentrations in whole blood,     plasma and urine.      Intraindividual cross over open comparison in healthy male and female individuals (6:6) with     different MB formulations in randomised order for the determination of the absolute     bioavailability of MB (part 1), followed by an explorative randomised parallel group     comparison of CQ disposition when CQ is given alone (3 males and 3 females) or in combination     with 1000 mg sustained release MB (3 males and 3 females) in the participants of study part 1     (part 2).   "
178086|NCT00176085|"     A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up to     now not conducted, except of one single experiment in which (lacking) psychopharmacological     activity was tested after intravenous infusion of 20 mg in a human individual. In this study,     however, the authors did not trace the above questions due to analytical and methodological     deficits.      Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after     intravenous ad-ministration of 5 mg THCCOOH in healthy individuals   "
178087|NCT00176098|"     Perioperative stress for cataract surgery in the elderly is considerable even in the absence     of pain. For these patients with a high comorbidity level, the perioperative situation     comprising factors such as uncomfortable positioning, dull ambience, face cover, poor     sedation, and anxiety might not only reduce intraoperative compliance but induce cardiac     ischemia and hypertensive crises. Hypnosis is supposed to increase patient comfort, to shield     the patient from organic stress and to improve intraoperative compliance without side effects     even in old and very ill patients. In a controlled study, we, the investigators at the     University of Heidelberg, compared phakoemulsification under topical anesthesia as usual (and     placebo hypnosis) with either additional hypnosis or hypnoanalgesia without topical     anesthesia.   "
178089|NCT00176124|"     Leukocyte depletion of autologous whole blood prior to storage does not reduce infection rate     (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay but     may increase retransfusion perioperatively during hip arthroplasty and allogenic transfusion     rate   "
178090|NCT00176137|"     Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by     hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery     and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide,     followed by surgery and then RT.      The primary endpoint was progression free survival (PFS). With 500 patients evaluable an     improvement of median PFS from 10 to 14 months could be detected.   "
178091|NCT00176150|"     The aim of this study is to investigate whether patients with anorexia nervosa have elevated     plasma cholesterol levels and, if elevated plasma cholesterol levels influence drug transport     by the ABC-transporter P-gp (P-glycoprotein, MDR 1/ABCB1). We will isolate peripheral blood     mononuclear cells (PBMCs) and total RNA from the blood of patients with anorexia nervosa and     healthy subjects as control. PBMCs will be used for quantitative cholesterol determination     and for measuring the activity of P-gp using a FACS (fluorescence-activated cell sorting)     method (rhodamine123 efflux). Total RNA will be used for quantitative expression analysis of     P-gp by reverse transcriptase real time PCR.   "
178092|NCT00176163|"     It is known, that a so called pain memory usually evolves in chronic pain syndromes which     both aggravates the disorder and modifies the patients pain perception. Thus, the principal     object of pain therapy is to delete this dysfunctional pain memory. The combination of     medication, physiotherapy and psychological therapy seems to be the most effective treatment.     This study investigates the effect of a concomitant Dronabinol medication (Cannabinoid) on     the effectiveness of behavioral therapy. It is hypothesized that the combination of     behavioral therapy and Dronabinol will be most effective in deleting the pain memory.   "
178093|NCT00176176|"     In this study, changes in electroencephalogram (EEG) and the hemodynamic state during     ventricular fibrillation or induced ventricular tachycardia are investigated.   "
178094|NCT00176189|"     Fixed-partial dentures fabricated of zircon-oxide ceramics were introduced in dentistry some     time ago. However, the survival rate of all-ceramic extended (up to 47mm) fixed-partial     dentures is unknown.      The hypothesis was that long FDPs fabricated of zirkon-oxide withstand masticatory forces in     the posterior and anterior regio of the jaw.   "
178095|NCT00176202|"     The study is to examine the null hypothesis that risperidone and divalproex sodium are     equally effective in treating/stabilizing pediatric bipolar disorder.   "
178096|NCT00176215|"     The aim of this prospective clinical trial was to investigate the clinical performance and     complication rate of RPDs (Removable partial dentures) retained on conventional conical     double crowns in comparison to galvanoformed telscopic double crowns. Additionally the OHIP     (Oral Health related Qualitiy of Life)and the abrasion of the teeth were investigated.   "
178097|NCT00176228|"     There are two purposes for this project. Study 1 is intended to study the safety and efficacy     of Lamotrigine in stabilizing the mood in all phases of pediatric bipolar disorder (Phases:     mixed, manic, hypomanic, or depressed episodes) in 8-17 year old children. These children and     adolescents must be treatment resistant (who failed on two adequate trials of mood     stabilizing medications) to qualify for this study. Study 2 is aimed at examining brain     activity and/or dysfunction before lamotrigine treatment, and to look for any alteration     after lamotrigine treatment. Brain systems associated with attention and emotional processing     will targeted.   "
178098|NCT00176241|"     This study seeks to establish the safety of gemcitabine, paclitaxel and low-dose radiation in     recurrent, metastatic head and neck cancer through a two-stage dose escalation study, first     with Gemcitabine dose escalation and then with low-dose radiation escalation.      Treatment Schedule      Treatment will be administered on an inpatient or outpatient basis.        -  Gemcitabine:2000 to 3000mg/m2 IV (in the vein) on days 1 and 15 every 28 days over 30-60          minutes.        -  Paclitaxel: 150 mg/m2 IV(in the vein)on days 1 and 15 every 28 days over 60 minutes.        -  Low Dose Radiation: 50-80 cGy twice daily on days 1, 2, 15, & 16 every 28 days at least          4 hours apart.   "
178099|NCT00176254|"     This study utilizes two cycles of Paclitaxel and Carboplatin chemotherapies followed by four     small doses of radiation, prior to other treatment (surgery or radiation). This study is     evaluating if radiation as a chemoenhancer increases the response rate of initial therapy.   "
178100|NCT00176267|"     This study is being performed utilizing two cycles of Paclitaxel and Carboplatin, plus low     doses radiation as initial therapy prior to other treatment (surgery or radiation). The study     is assessing if utilization of low doses radiation as a chemoenhancer will further increase     the response rate seen with initial therapy.   "
178101|NCT00176280|"     -Overall study design: A randomized Phase II study in patients with metastatic RCC Patients     will receive chemotherapy with gemcitabine and 5-FU. Prior to each chemotherapy the patient     will receive a combination of Leukine alone (study cohort 1) or Leukine-dexamethasone (study     cohort 2).      -Chemotherapy: gemcitabine 1.0 g/m2 intravenously (infused in the vein)over 30 minutes on     Days 7 and 21, Folinic acid 200 mg/m2 on Days 7-8 and 21-22, then 5-FU 400 mg/m2,     intravenously (infused in the vein) over 30 minutes followed by 5-FU 600 mg/m2 intravenously     (infused in the vein) over 24 hours.      •Study drugs:        -  Cohort 1, Leukine, 250 ug/m2 daily (8 am) subcutaneously (under the skin) on days 1, 2,          3, 4, 5 and 15, 16, 17, 18, and 19;        -  Cohort 2, Leukine, 250 ug/m2 daily (8 am) subcutaneously (under the skin)on days 1, 2,          3, 4, 5, and 15, 16, 17, 18, and 19 and dexamethasone 12 mg every 12 hours (8 am and 8          pm) orally (by mouth) on days 3, 4, 5, 6, 7, 17, 18, 19, 20, and 21.   "
178142|NCT00166660|"     The goal of the project is to show the effectiveness of individualized developmental care and     intervention, which begins with the FGR preterm infant's admission to the newborn intensive     care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA     (corrected age for prematurity).   "
178173|NCT00167063|"     The purposes of this study are: (1) to investigate the incidence and causes of falls of     stroke patients residing in Taipei City and Taipei county after their discharge from the     National Taiwan University Hospital, (2) to investigate the relationship between clinical     manifestations of stroke patients before their hospital discharge and their incidence of     falls after hospital discharge, and (3) to identify the risk factors for stroke patients who     frequently fall after hospital discharge.   "
178433|NCT00179205|"     In this study, the investigators hypothesize that long-term administration of adequate     intradialytic oral nutritional supplementation will increase visceral protein concentrations     and somatic protein stores in malnourished chronic hemodialysis patients.   "
178102|NCT00176293|"     The primary objective of this study is to assess disease response to Doxil in patients with     hormone refractory prostate cancer with or without dexamethasone pre-treatment.      Study Design:      We will perform an open labeled, parallel, randomized phase II study using a two-stage design     to determine if there is sufficient anti-tumor activity in either arm to warrant further     study. Assumptions made in this study: an unacceptable overall response rate is </= 10% & we     will pursue further study if the overall response rate is >/= 30%. Fifteen patients will be     randomized in the first phase (to both Arm 1 and Arm 2). No further patients will be accrued     if <2/15 responses are noted in a given arm. Ten additional patients will be enrolled if >/=     2/15 responses are observed. If there are >/= 5/25 responses then further studies will be     pursued with that regimen. We will determine the overall incidence & severity of toxicities     in both arms.      Treatment:      Arm 1: Doxil: Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 2: Doxil:     Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 1 only: Dexamethasone:     Dose: 12 mg twice a day by mouth on days 1, 2, 3, 4, 5 of each 28 day cycle.      Number of Cycles for both Arm 1 & 2: until progression or unacceptable toxicity develops.   "
178103|NCT00176306|"     Obesity is known to affect the concentrations of certain medications in the body.     Levofloxacin is a commonly used antibiotic. Based on what the investigators know about     levofloxacin and how it moves through the body, obesity may affect levofloxacin     concentrations. This study aims to show the effect of obesity on levofloxacin concentrations.      The hypothesis is as follows: A 750 mg intravenous (IV) dose of levofloxacin administered to     severely obese, critically ill patients will yield serum concentrations that are likely to be     therapeutic.   "
178104|NCT00166153|"     The survival of children who have received heart transplants has greatly improved over the     last ten years. One reason for this is better control over rejection. Rejection medications     require a delicate balance of enough medicine to work without causing side effects. It is a     goal to avoid both rejection and side effects from the anti-rejection medicines. Usually     several medicines are used together to prevent rejection. One of these medicines is often     Mycophenolic Acid or CellceptThis medicine has been used longer for adults than is has for     children. More information is needed on using it for children. The dose is usually determined     by the patient's weight or body surface area.      There have been some early studies of the use of Cellcept, but none have proven a     relationship between the blood level of the drug and how well it works. More also needs to be     known about how this drug works with other anti-rejection drugs and how it works in boys and     girls. This study will look more closely at proper dosing, how Cellcept works with other     anti-rejection medications, side effects, and any differences in how this medicine works in     boys and girls.      All patients in the study will be receiving Cellcept and have blood levels of the drug drawn.     Results of their usual treatment and testing will be recorded and evaluated for signs of     rejection. All the information will be analyzed. Results of this study will be reported to     transplant committees locally and nationally.   "
178105|NCT00166166|"     The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor     (EDHF) plays in dilating blood vessels and whether it differs between healthy people and     those with high cholesterol. A second purpose of the study is to determine the identity of     EDHF.   "
178106|NCT00166179|"     The purpose of this study is to compare cardiac MRI with positron emission tomography (PET)     with fluorodeoxyglucose (FDG) to determine if cardiac MRI images are as good as, or better,     than PET with FDG.   "
178107|NCT00166192|"     Melasma is an acquired discoloration of the skin characterized by brown patches. Chemical     peels using agents such as Jessner's solution and trichloroacetic acid (TCA) are commonly     used to treat melasma. A chemical peel involves applying the peeling agent to the skin for a     short period. The skin will peel similar to a sunburn, and moisturizers are applied to the     skin. Although both agents are well-accepted, there have been no good comparisons of the two     agents. The purpose of this study is determine if there is a difference in the effectiveness     of these two agents.   "
178108|NCT00166205|"     The purpose of this study is to determine whether the Swedish Adjustable Gastric Band (SAGB)     is safe, and effective in achieving weight loss in patients with Morbid Obesity.   "
178109|NCT00166218|"     The normal heart has four chambers. There are two upper (or filling) chambers and are called     the atrium. There are two lower (or pumping) chambers and are called the ventricles. One of     the ventricles pumps blood to the lungs to get oxygen. This oxygenated blood is returned to     the heart then pumped to the rest of the body by the other ventricle.      Sometimes babies are born with heart defects that only allow one of the lower chambers     (ventricle) to work properly. This means that the one ventricle must pump blood to both the     lungs and to the rest of the body. Babies born with this defect must undergo multiple     surgeries, the first of which is usually done during their first week of life.      There is a machine that is FDA approved that can measure how much oxygen is delivered to the     brain. This non-invasive (outside the body) machine uses Near-infrared spectroscopy (NIRS),     which is similar technology used in pulse oximetry and is routinely used to measure the level     of oxygen in blood. At Children's Healthcare of Atlanta, we typically place the NIRS machine     on the baby in the Cardiac Intensive Care Unit immediately after their first surgery to     monitor oxygen delivery to the brain. The monitor has proven to be accurate in this     situation.      We now want to know if we can use this monitor to assess oxygen delivery to the brain before     and during a routine heart catheterization prior to the child's second surgery. Once consent     is obtained, we will place a probe on the child's forehead during the pre-catheterization     visit and obtain readings for 5 minutes. The probes are about the size of a quarter and are     self-stick (they look like the kind of leads used to measure the babies heart rate [EKG]).     The machine will be disconnected for the rest of the Pre-catheterization visit, however the     probes will stay on the child's forehead. Once the child is in the catheterization suite, the     machine will be reconnected. A sheath or hollow tube is routinely placed in a blood vessel in     the child's neck or groin for the catheterization. The doctor would place a special catheter     in this sheath that measures oxygen levels in blood continuously. This monitor would be     calibrated by using the results of a blood sample that is routinely drawn from the child's     IV. During the same sampling, an additional 2cc's of blood would be collected to measure the     lactate level. The lactate level is an indicator of how well the child is using oxygen. Once     this monitor is calibrated, data will be collected for 5 minutes to compare it with the NIRS     machine. The special catheter will be removed after the 5-minute time period, and the     catheterization will proceed as usual. The NIRS probes will stay on the child's forehead     during the entire catheterization with the data documented. At the end of the     catheterization, the probes will be removed.   "
178143|NCT00166673|"     This study is being done to find out how accurate the Navigator continuous glucose monitor is     in children. It is also being done to see if use of the Navigator can improve blood sugar     control and help prevent low blood sugar events. This study has three basic parts: Use of the     Navigator at home for one week without being able to see the blood sugar readings; a Baseline     visit or a 24-hour admission to a research unit of the hospital to find out how well the     Navigator measures the blood sugar; and then 3 months use of the Navigator at home as an aid     to diabetes care.   "
178144|NCT00166686|"     The goals of the study are to determine the efficacy of clonidine in the treatment of     children with neurocognitive sequelae following the therapy of long term malignancies. In     addition, the study hopes to determine the long-term effect of clonidine on children's     academic and psychosocial function.   "
178110|NCT00166231|"     The causes of pediatric pain are often not the same for every child. Most children who visit     a cardiology specialist with complaints of chest or other somatic pain have no known medical     diagnosis to explain their symptoms. These children and their families often leave with no     explanation for the child's distress.      This early study will ask parents and children specific questions related to the stress in     their lives, their emotional well-being and the children's physical functioning. The     investigators want children who experience chest and other somatic pain, and those who do     not, to be in their study so that they can look at both groups.      The investigators hope to use these answers to better inform cardiologists who often work     with children with non-cardiac pain and, in turn, help them to better serve their patients.     Ultimately, the investigators hope that the answers they get will provide answers to these     families. They also hope to use the results of this study to put together a short screener     for the cardiologist to give to pediatric patients with complaints of chest or other somatic     pain to help the cardiologists better understand their patients' symptoms.   "
178111|NCT00166244|"     Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared     with fixed dosing in de novo MMF treated renal transplant recipients with respect to the     incidence of treatment failure.   "
178112|NCT00166257|"     The purpose of this study is to compare two treatments strategies to prevent further attacks     in patients who have suffered an stroke or occlusion of a major artery with no obvious reason     other than a persistent small opening between the upper heart chambers   "
178113|NCT00166270|"     This is a prospective, nonrandomized, multi-center study to evaluate the safety and     effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated     and then followed for 36 months to evaluate the change in their fibroid symptoms.   "
178114|NCT00166283|"     The current study is a double-blind, placebo-control randomized clinical trial examining the     efficacy of memory retraining in Multiple Sclerosis (MS). Impairment in higher level     cognitive processing, such as new learning and memory, is one of the most common deficits in     individuals with MS and such deficits have been shown to exert significant negative impact on     multiple aspects of everyday life, including occupational and social functioning. Despite     these findings, few studies have attempted to treat these cognitive deficits in order to     improve the everyday functioning of individuals with MS. Through a small randomized clinical     trial, we found that individuals with MS with documented memory impairment show a significant     improvement in their memory performance following a treatment protocol designed to facilitate     learning. The current proposal will replicate this finding and further evaluate (a) the     impact of the treatment on everyday functioning, (b) the long term efficacy of the treatment     and (c) the utility of booster sessions in facilitating long-term treatment effects. We will     randomly assign individuals with MS, with documented impairment in new learning abilities, to     a memory retraining group or a placebo control group. Both groups will undergo baseline,     immediate and long-term follow-up assessment consisting of: (1) a traditional     neuropsychological battery and (2) an assessment of global functioning examining the impact     of the treatment on daily activities. This design will allow us to evaluate the efficacy of     this particular memory retraining technique in an MS population through the assessment of     cognitive function via a standard evaluation. In addition, we will be able to draw     conclusions regarding the impact of this particular memory remediation program on everyday     life from questionnaires completed by the participant and a significant other. Optional     enrollment in pre- post neuroimaging will also allow us to look at changes in the brain.   "
178115|NCT00166296|"     The purpose of this study is to determine whether the use of an antidepressant (escitalopram)     can prevent depressive episodes that appear during the treatment with peg-interferon and     ribavirin in patients with chronic hepatitis C.   "
178116|NCT00166309|"     FENOC is a prospective, open-label, randomized, cross-over, multi-center study to investigate     and compare the hemostatic effect and cost-efficacy of two different by-passing agents in the     treatment of joint hemorrhages in subjects with severe hemophilia A and inhibitors. The study     is designed as a clinical equivalency trial.   "
178117|NCT00166322|"     This study is an investigation of the dopaminergic neurotransmission in patients with     schizophrenia, patients at risk for the development of schizophrenia, and healthy controls     using an iodobenzamide-single photon emission computed tomography (IBZM-SPECT) imaging     technique under amphetamine challenge.   "
178118|NCT00166348|"     The purpose of this study is to determine whether there is benefit from providing cognitive     rehabilitation in the group setting. Several standardized tools will be used to measure     progress when a participant enters the group, leaves the group and at a one year follow-up.   "
178119|NCT00166361|"     The purpose of this study is to evaluate the safety and efficacy of the Memokath 051 ureteral     stent as a long-term temporary and minimally invasive means of providing ureteral drainage in     the setting of malignant extrinsic ureteral obstruction secondary to inoperable abdominal or     pelvic malignancies. Up to 15 adults who have extrinsic ureteral obstruction secondary to an     inoperable abdominal or pelvic malignancy and need ureteral stent drainage will undergo     outpatient placement of the ureteral stent. Ongoing monitoring will continue for as long as     the stent is in place.   "
178120|NCT00166374|"     Patients with vertebral compression fracture will be treated cement injection into the spine     and monitored using standard evaluations.   "
178121|NCT00166387|"     Several non-genetic and genetic factors that could influence the risk of inhibitor     development in hemophilia A have been discussed but not fully explored. The aim of the HIGS     is to identify these genetic factors.   "
178122|NCT00166400|"     Mitral valve regurgitation (leakage of the mitral valve of the heart) is frequent and     currently there is no specific medical therapy. Mitral regurgitation is a slowly progressive     disease that frequently requires surgical treatment. This randomized clinical trial will use     Metoprolol, a common beta-blocker medication, to determine if medical treatment impacts     mitral valve disease progression.   "
178123|NCT00166413|"     Patients with primary systemic amyloidosis will be treated with CC-5013 (lenalidomide;     Revlimid) as a single agent for 3 months. If their disease worsens or does not improve during     that time frame dexamethasone will be added to the treatment program.   "
178124|NCT00166426|"     This is a study in which patients with prostate cancer treated by surgical removal of the     prostate and considered to be at risk for prostate cancer recurrence will receive Exisulind     250 mg twice a day or placebo twice a day for two years.   "
178125|NCT00166439|"     The goals of this protocol are to determine the effect of oxaliplatin, cytosine arabinoside,     and dexamethasone with Rituxan (ROAD) as treatment for patients with relapsed CD20+ B-cell     non-Hodgkins lymphoma (NHL).   "
178126|NCT00166452|"     The purpose of this study is to determine if lenalidomide is a safe and effective treatment     for complex regional pain syndrome type 1 (CRPS).   "
178169|NCT00167011|"     To test the ability of electron beam CT in evalting the coronary artery pattern in children     with congenital heart disease.   "
178127|NCT00166465|"     Phase I: The primary objective of the Phase 1 portion of this study is to determine the     Maximum tolerated dose and the recommended Phase 2 dose of ALIMTA plus oxaliplatin when given     with folate and vitamin B-12 supplementation in the treatment of patients with unresectable,     locally advanced or metastatic colorectal cancer. The Phase I component of the study will be     activated for enrollment of Mayo Clinic patients only.      Phase II: The primary objective of the Phase 2 portion of this study is to determine the     tumor response rates to ALIMTA plus oxaliplatin and oxaliplatin plus 5-fluorouracil and     leucovorin in patients with locally advanced unresectable or Stage IV colorectal cancer that     have not received prior chemotherapy for advanced disease. Patients will be randomly assigned     to receive either ALIMTA plus oxaliplatin (Arm A) or Oxaliplatin plus 5-Fluorouracil and     Leucovorin (Arm B). The Phase II component of the study will be activated for enrollment of     patients via the Mayo Clinic Cancer Research Consortium mechanism. A comparison will be made     of the side effects between regimens.   "
178128|NCT00166478|"     This trial will compare no treatment to exisulind therapy. Patients enrolled on the treatment     arm will begin treatment 4 weeks prior to the scheduled date of surgical removal of the     prostate and will take 375 mg by mouth daily for the 4 weeks prior to radical prostatectomy.     Participants will be followed for total of 2 months from the time of starting study drug.   "
178129|NCT00166491|"     The purpose of this study is to determine if there is any difference between two ways of     controlling blood sugar with insulin. In patients admitted to the intensive care unit, blood     sugar levels often rise due to the stress of illness or surgery. Studies have shown that     patients do better if their blood sugar is kept normal. In order to maintain normal blood     sugar levels, the investigators often give insulin (a substance made by the body), and they     decide how much to give based on how high the blood sugar is. This study will compare two     different ways of deciding how much insulin to give and compare how well each method keeps     the blood sugar in a normal range. Both ways of controlling blood sugar are     institutionally-approved protocols and part of routine care.   "
178130|NCT00166504|"     This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to     atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in     Korea. The primary hypothesis being tested is that daily administration of Vytorin will     result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration     from baseline after 6 weeks treatment compared to atorvastatin.   "
178131|NCT00166517|"     Immunogenicity and Safety of V260 in Healthy Infants in Korea   "
178132|NCT00166530|"     In patients with coronary artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L     on a stable (> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg),     investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg     simvastatin or 20 mg atorvastatin) versus a combination tablet of ezetimibe 10 mg plus     simvastatin 20 mg once daily for 12 weeks. It is postulated that more patients reach their     LDL-C treatment goal with the combination tablet compared to doubling the starting dose.     Furthermore, the effect of both treatment regimens on other lipid parameters, safety and     LDL-subfractions will be measured.   "
178133|NCT00166543|"     This study is being done to find out how safe TAS-108 is and how well TAS-108 works on     recurrent or recurrent inoperable breast cancer.   "
178134|NCT00166556|"     This is a prospective, multicenter open-label single arm trial in which recipients of liver     allograft will receive uniform immunosuppressive induction and maintenance regimens.     Participants with end stage liver disease who meets the entry criteria will be consented and     enrolled.      Participants receive Campath-1H and maintenance immunosuppression with tacrolimus therapy.     After one year of tacrolimus therapy, an assessment of the immunologic status including blood     gene expression and geno-race studies will be performed which will include studies on the     liver graft biopsy. At this time, patients will be selected to undergo immunosuppressive     withdrawal. This will be made on an individual basis with definitive inclusion and exclusion     criteria.      The objectives of the study are to evaluate the safety and efficacy of immunosuppressive     regimens comprising Campath-1H induction followed by maintenance immunosuppressive therapy     with tacrolimus on allograft survival. However, secondary objectives will be to assess     withdrawing tacrolimus after Campath-1H induction in an immune depletion and subsequent     immune reconstitution. This study will evaluate whether a combination of anti-rejection     medications (Campath-1H and tacrolimus) can prevent rejection and allow the body to develop     tolerance to the transplanted liver.   "
178135|NCT00166569|"     The goal of this study is to determine the genetic basis of polycystic ovary syndrome (PCOS).     We will first look for genes in the Icelandic population, where large family trees are known     and it is easier to search for genes. We will then determine whether these same genes are     important in U.S. PCOS patients.   "
178136|NCT00166582|"     The purpose of this research study is to examine the effectiveness of a parent-youth teamwork     treatment and an asthma education treatment in helping children use their asthma medicines     correctly. We also want to learn about how these treatments affect parental involvement in     asthma care, parent and youth relationships, and children’s health care.   "
178137|NCT00166595|"     The purpose of this study is to determine if the known differences in genes influence drug     metabolizing enzymes and receptors that are involved in risperidone drug action. The study     will determine if differences in these genes will change the concentration of risperidone in     the blood over time in children in relation to side effects and clinical response to     risperidone.   "
178138|NCT00166608|"     Genotyping assays for polymorphisms in the interleukin 10(IL10)gene and the inducible nitric     oxide synthase (iNOS) gene will be performed. Genotypes will be compared to the severity of     toxicity following overdose.   "
178139|NCT00166621|"     The purpose of this study is to determine the efficacy, safety, and population     pharmacokinetics and determinants of drug responses to buspirone in children with autism     using a randomized, double blind, cross over study in children ages 2 to 6 years.   "
178140|NCT00166634|"     The primary objective of this proposal is to demonstrate that ABPM can be used to improve     study design for interventional trials in children with hypertension.   "
178141|NCT00166647|"     The purpose of the study is to determine the frequency of allelic variants in TPMT in the     Hispanic population and to compare the frequency in the Hispanic population with the     Caucasian Population.   "
178145|NCT00166699|"     The study will establish whether the use of ultrasound scanning with a purpose built probe     will aid the insertion of the needles for epidural and spinal anaesthesia for obese women     undergoing elective caesarean section The study group will be 46 obese women (defined by the     ratio of height to weight) at time of initial booking ultrasound scan, undergoing routine     caesarean section with no serious illnesses that are both willing and able to provide     informed consent prior to spinal epidural anaesthesia. Patients will be excluded if they have     signs or symptoms of systemic or local infection, if they have a history of previous spinal     surgery, a blood clotting abnormities.      In order to evaluate the clinical usefulness of the ultrasound probe a randomised comparison     of the traditional clinical methods of feeling the bones of the spine and ultrasound guided     insertion of a combined spinal epidural anaesthetic will be undertaken. The rodiera tiped     17/18G 90mm tuohy needle and 123mm 27G spinal needle manufactured by Sarstedt will be the     regional needles used for the combined spinal epidural anaesthetic. Randomisation into two     groups (ultrasound guided needle insertion and feeling the bones) will be by computer     generated random sequence. This information will be recorded in sealed envelopes and placed     in the ward. Patients who meet the inclusion criteria and who consent immediately prior to     caesarean section will be sequentially assigned a number that will correspond to a sealed     envelope. The main aim of the study will be to detect any difference in time taken to insert     epidural catheter via the needle in the patients back. The other factors measured will be the     number of times the skin is punctured and bone touched by the needle, number of conversions     from regional (spinal epidural) to general anaesthesia, patient satisfaction scores,     requirement for extra local anaesthetic following initial blockade during Caesarean section.      The factors will be compared by student t-test using Statistica6 (StatSoft,Inc.(2001).     STATISTICA (data analysis software system), version 6. www.statsoft.com). A population of 46     patients will be required assuming a mean time for inserting a combined spinal epidural     without   "
178146|NCT00166712|"     This is an open label, single-center, randomized phase IV pilot study of steroid and     calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive two     doses of alemtuzumab to achieve peripheral T-cell depletion. Intravenous glucocorticoids will     be administered prior to alemtuzumab administration to limit cytokine release syndrome in     association with this monoclonal antibody, and continued for the first two days     post-transplant. Thereafter, steroids will not be used for immunosuppression. All transplant     recipients will be started on oral immunosuppressive therapy with mycophenolate mofetil (MMF)     prior to transplant. Pretransplant, these patients will be randomized to receive, in     addition, either tacrolimus (Tac) or sirolimus.      After six months, patients in the tacrolimus arm who do not experience rejection will be     randomized to continue on tacrolimus or to be converted to the combination of sirolimus and     MMF. Individuals in this arm of the study who do not experience acute rejection, and     demonstrate evidence of donor specific hyporesponsiveness at 9 months post-transplant (those     staying on Tac + MMF) or 3 months post-conversion (those converted from Tac + MMF to     sirolimus + MMF) will be weaned to MMF monotherapy.      Individuals in the sirolimus + MMF arm who do not experience acute rejection and demonstrate     evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to     MMF monotherapy.   "
178147|NCT00166725|"     The present study will provide information on whether the somatostatin analog, octreotide     acetate, could have an inhibitory effect on circulating chromogranin A. The demonstration of     an antisecretory effect of somatostatin analogs could offer a rationale for a large scale     randomized study.   "
178148|NCT00166738|"     Persons with schizophrenia experience imaginary voices, visions and disorganized thoughts,     and are handicapped when it comes to social life, which is detrimental to the affected     individuals and the community. Although the pathogenesis of this mental disease has not been     clearly elucidated, much evidence suggests that inheritance is of major etiological     importance and multiple genetic components are implicated. Previous linkage studies of     familial schizophrenia have led to the successful identification of numerous susceptibility     loci covering many of the human chromosomes, including chromosome 1q, 5q, 6p22, 6p24, 8q21,     13q32, 15q13-14 and 22q11, etc. Necessities for further identification of candidate genes     involved in familial schizophrenia by taking a genome-wide approach are listed as follows:        1. given that multiple genes are responsible for this disease, it is of critical interest          to view the complete molecular profiling of schizophrenia's genome;        2. identification of promising schizophrenia candidate genes by genome-wide scanning will          facilitate the development of molecular markers and provide a more objective and          effective assessment method in psychotic diagnosis and prognosis;        3. prevention of the onset of this disorder will be improved by early classification of          individuals bearing strong genetic loading for schizophrenia as a high risk population;        4. making a breakthrough into the investigation of schizophrenia pathogenesis by the          characterization of susceptible genes found by genome-wide exploring.      Array-based comparative genomic hybridization (CGH) allows high-throughput genome-wide survey     for DNA copy number aberrations, providing a powerful tool for investigating genetic     disorders and for developing diagnostic and therapeutic targets. Arrays used in this study     consist of approximately 43,000 60-mer oligonucleotide probes that span coding and noncoding     regions of the whole human genome with an average spatial resolution of around 35 kb.     Furthermore, the sensitivity of these arrays is capable of detecting and mapping regions of     single-copy losses, homozygous deletions, and amplicons of various sizes even when using     full-complexity genomic samples. In this study, the investigators will conduct an array-based     comparative genomic hybridization (CGH) with genomic DNA of many affected members from     schizophrenia families (the investigators classified families according to the presence or     absence of two or more affected members) to identify a set of candidate genes associated with     this disease. It is hoped that the results obtained from this study will improve the accuracy     and efficiency of psychotic treatment.   "
178149|NCT00166751|"     Ultrasonographic examination has long been used to assess the swallowing function. It has the     advantages of no ionizing radiation on examination and the possibility of using the real food     instead of the barium meal in testing. Thus, the subjects can be examined repeatedly and in a     more physiological status of swallowing. However, the ultrasonographic examination is only     used in assessing the oral phase of swallowing. It can accurately visualize the tongue     movement, measure the oral transit time of bolus, and sometimes the hypoid bone motion, but     has not been applied on the evaluation of pharyngeal phase of swallowing. Physically,     laryngeal elevation is an essential component of the swallowing movement on pharyngeal phase.     It ensures the occlusion of airway and opening of criopharymgeus muscle, and thus prevents     the aspiration. To evaluate the laryngeal elevation is crucial point in managing the     dysphagic patients.      The purpose of this project is to measure the laryngeal elevation in normal and in dysphagic     patients with cerebrovascular (CVA) accident using ultrasonographic techniques. This work     will include four group subjects. The first group consists of 20 young subjects (< 40 years);     the second group consists of 20 age-matched normal subjects; the third group consists of 20     CVA patients without swallowing problems, and the fourth group consists of 20 CVA patients     with dysphagia, which was proven by VFSS. The laryngeal elevation is detected by ultrasound     with the transducer placing between the hyoid bone and thyroid cartilage. The two markers are     easily detected on sonogram because of the presence of acoustic shadow, a specific character     of bony structure on sonogram. The distance between the hyoid bone and thyroid cartilage     before and during swallowing is measures and compared among the groups. The distance change     of the patients with dysphagia is further compared with that defined by VFSS. With the result     of this study, we will understand the status of laryngeal elevation during swallowing in     normal and dysphagic subjects, and further determine the accuracy of ultrasonographic     measurement in measuring the laryngeal elevation. With this knowledge, we might extend the     usage of ultrasonographic examination on evaluating swallowing function.   "
178170|NCT00167024|"     Primary: to investigate the effects of DNA repair gene polymorphisms on prostate cancer     susceptibility, pathological grade, disease stage and clinical outcome Secondary: to     understand the association between DNA repair gene polymorphism and prostate cancer and     provided important information for screening, prevention and treatment of prostate cancer   "
178171|NCT00167037|"     The purpose of this study was to compare the balance strategy, as well as center of pressure     (COP) trajectory and parameters between healthy adults and patients with hemiplegia in     response to slow- and fast-speed waist- pulling perturbations in forward, left, right, and     backward directions.   "
178174|NCT00167076|"     The purposes of this paper were to determine whether walking speed affected gait parameters     and force impulse in patients with stroke or not, and if the changes varied in various foot     regions.   "
178448|NCT00179426|"     The purpose of this study is to determine if antiseizure drugs affect hormone levels and     sexual function in men with seizures.   "
178150|NCT00166764|"     Psychiatric patients under the mental impaired influences, their living function were     disabled, and their social lives were handicapped consequently. Idea psychiatric treatment is     to control the psychiatric symptoms in a better way, to develop efficient psychiatric     adjustment, to manage living stress into a lower level, to gradually develop the meaning and     value of the patients’ lives, and to obtain the satisfaction and happiness in life for them.     In order to investigate the satisfaction for psychiatric patients under the current treatment     and to evaluate their psychiatric health, it is necessary to measure the mental health status     for the psychiatric patients, and to ensure the ideological status of psychiatric treatment.     If there is a mental health measurement for the psychiatric patients, we may precisely     identify the mental health levels of the patients and their mental disturbances degrees.     Accordingly, we may develop efficient procedure to manage the mental health for the     psychiatric patients, and to achieve the goal for the idea psychiatric treatment.      In this study, we established the mental health assessment data sheet according to the     clinical experiences. It includes mental health index data sheet, mental-and-physical stress     response data sheet, mental sustentation data sheet, and supplemented with a general living     satisfaction assessment data sheet. We will evaluate the reliability and validity of this     study to ensure the usability of these data sheet in clinics. We will also recruit the     continuous treated and mentally stabilized patients as subjects. After obtaining their     written informed consents, we will go through these mental health assessments to discover the     mental health status of these psychiatric patients, and use it as a reference to develop idea     psychiatric treatment. We will use ICC test for the repeated measurement validity, Pearson r     correlation coefficient within our data analyses to evaluate the validity of the same     measurement, and independent t-test to assess the differences between the patient group and     the society group (from previously established data files). This study result may evaluate     the possible deficits existing in the traditional psychiatric treatment and may be used as a     reference for the development of idea psychiatric medicine.   "
178151|NCT00166777|"     Quadriceps retraining, especially the vastus medialis oblique muscle strengthening, plays an     important role in clinical management of patellofemoral pain syndrome. Vastus medialis     oblique muscle roles as a dynamic stabilizer during the functional knee movement. It can     generate a medial pulling force to patella against the lateral pulled by vastus lateralis.     Thus it improves the patellofemoral joint compression force, reduces the knee pain, increases     functional abilities, and patients’ quality of life.      Could vastus medialis oblique be isolation by way of specific exercise without or minimize     the recruitment of vastus lateralis？ According to human anatomy, vastus medialis oblique     muscle origin from hip adductor magnus tendon, thus if incorporate hip adduction with knee     extension as a selective means of training needs more researches. However, literature search     shows that there are only a lot of EMG studies, so we need further clinical research to prove     the treatment effect of this kind of strategy.      The purpose of the study is to investigate the treatment effects of hip adduction combine     knee extension exercise in patients with patellofemoral pain syndrome. We use muscle     morphology of quadriceps muscle, pain, and functional abilities as the main outcome measures.     Besides, we will make further compare with traditional knee extension exercise. The first     hypothesis of the study is that patients with patellofemoral pain syndrome will get     improvement in muscle morphology of quadriceps muscle, pain, and functional abilities after     hip adduction combine knee extension exercise training . The second hypothesis is that     patients with patellofemoral pain syndrome who receive hip adduction combine knee extension     exercise training will get more improvement in muscle morphology of quadriceps muscle, pain,     and functional abilities than patients who receive traditional knee extension exercise     training.      90 patients with patellofemoral pain syndrome who less than 50 years old will be included in     this study, and randomly distributed to hip adduction combine knee extension exercise group,     knee extension exercise group, and control group. Following 8 weeks exercise training by an     experimental physical therapist, ultrasound measurement of muscle thickness and     cross-sectional area of vastus medialis oblique muscle, vastus lateralis muscle, and rectus     femoris muscle component of quadriceps, 10cm-VAS patellofemoral joint pain evaluation,     including VAS-U, VAS-W, and VAS-activity, and Lysholm scale scores will be measured. A     two-way mixed ANOVA will be used to compare the mean differences between theses three groups.      The study is aimed to provide an clinical evidence for evidence-based practice of     rehabilitation in patients with patellofemoral pain syndrome.   "
178152|NCT00166790|"     We will try to use the novel analytical technique -Dual Polarisation Interferometry (DPI),to     achieve detection the minimal amount of the human chorionic gonadotropin for early detection     and strict monitor of the GTD.   "
178153|NCT00166803|"     Cardiovascular events are the leading cause of death in developed countries worldwide,     including Taiwan. The disruption of atherosclerotic plaques and the subsequent formation of     thrombi are currently recognized as the major cause of morbidity and mortality of     cardiovascular diseases. Therefore, early detection of vulnerable plaques is clinically     important for risk stratification and also to provide early treatment. Several imaging     approaches have been adapted to detect vulnerable plaques, however, most of them are based on     morphologic characteristics of atheroma. We hypothesize that PPARγ-induced plaque regression     could be monitored clinically by use of 18FDG PET/CT approach, which could assess the     inflammatory activity, and can be detected noninvasively earlier than previously reported.   "
178154|NCT00166816|"     The purpose of this study is to understand the pharmacokinetic of sirolimus in different     regimens, as well as the dose-level relationship of cyclosporine and tacrolimus, and design     the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose     regimen for Taiwanese.   "
178155|NCT00166829|"     The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is     influenced by the concurrent use of sirolimus.   "
178156|NCT00166842|"     The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in     different regimens in newly renal transplant patients, and the effect of dosage form     conversion on the concentration of sirolimus in stable renal transplant patients. So that we     can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.   "
178157|NCT00166855|"     Background: Multiple myeloma (MM) is a clonal plasma cell neoplasm characterized by     proliferation of neoplastic plasma cells in bone marrow (BM). So far, it is an incurable     disease and the median survival time of MM patients is only three to four years. Till now,     whether the extent of angiogenesis in BM of MM patients serves as an important and     independent prognostic factor is still debated. In this study, we would like to have the BM     perfusion status imaged by dynamic MRI to mimic the macroscopic vascular densities of BM, and     thereafter, the BM perfusion status, the clinical outcome of the MM patients, and the     angiogenesis related biological markers will be correlated.      Methods: About 35 to 50 MM patients, included newly diagnosed patients or the patients who     will undertake the special treatment, are enrolled in this study. The thoraco-lumbar spine is     scanned by the MRI, and the BM perfusion status is obtained by contrast-enhanced dynamic MRI.     Meanwhile, the patients undertake BM biopsy at one site or two sites and the BM aspirates are     also obtained and separated into BM plasma and BM mononuclear cells (BMMC) by Ficoll-Hypaque     centrifugation. The angiogenesis related genes expression profiles of the BMMC will be     determined by cDNA microarrays and some of them, like VEGF, bFGF, and PDGF, will be     semiquantified by real-time PCR. The levels of related proteins will be determined by ELISA.     The BM plasma samples are further applied to proteomic analysis to screen the novel molecules     with clinical relevance.      Prospects: BM perfusion patterns imaged by dynamic MRI can predict the clinical outcome of     MM, and are correlated with the angiogenesis relevant biological markers in BM.   "
178172|NCT00167050|"     Superior limbic keratoconjunctivitis (SLK) was first described in detail as a clinical entity     by Frederick Theodore in 1963. The clinical picture of SLK is well documented, but the     etiology is still unknown. This project will be conducted into through two parts: one is to     investigate the presentation of chemokine receptors on mast cell and matrix     metalloproteinases on fibroblasts by immunohistochemistry method from the pathological     specimens of SLK patients who received conjunctiva resection as the treatment. The other part     is to investigate the mRNA level of those chemokine receptors via reverse transcription -     polymerase chain reaction from the conjunctiva collecting form SLK patients.   "
178175|NCT00167089|"     The purpose of this study is to explore an alternative approach that emphasizes task     specificity and treadmill training for ambulation training of these patients.   "
178158|NCT00166868|"     Abstract      Biliary atresia (BA) is an idiopathic, progressive, and fatal disease if untreated. Since     Kasai first introduced the operation for BA in 1959, there have been encouraging results in     treating this disease. Ascending cholangitis is a frequent and often recurrent complication.     It may worsen the prognosis, with an increase in mortality, secondary failure of restoration     of bile flow, and possible exacerbation of portal hypertension. For patients who have had     restoration of bile flow with a timely portoenterostomy, the recurrence of ascending     cholangitis is the single most significant variable pertaining to long-term prognosis.     Patients with multiple episodes of ascending cholangitis are more likely to require liver     transplantation than those without multiple recurrences. Therefore, the prevention of     cholangitis is crucial in the management of patients who have had a Kasai portoenterostomy.      Some oral antibiotics, like trimethoprim-sulfamethoxazole (TMP/SMZ) and neomycin have showed     the effect to prevent against ascending cholangitis. But, we should consider the problem of     drug resistance after long-term use of antibiotics. Is there any better and safer treatment?     Probiotics are live microorganisms, which have beneficial effects on human health. Many     studies have showed that probiotics have effects to treat or prevent intestinal infection or     inflammation even for patient after liver transplantation. The aim of this study is to     investigate the possibility of use of probiotics in prophylaxis of ascending cholangitis.      We want to enroll 20 BA patients aged 0 to 3 years, who had a Kasai operation. Ten patients     are treated with neomycin (25 mg/kg/d, qid, 4 days a week). Another 10 patients receive     Lactobacillus casei rhamnosus, Lcr 35 (8x108 CFU/day, bid) The duration of treatment is 6     months. Bacterial cultures of stool are performed before treatment and 1 month, 3 months and     6 months after treatment to evaluate the change of intestinal flora. Another 10 BA patients,     from 1991 to 1996, aged 0 to 3 years, without prophylaxis after portoenterostomy, were served     as the historical control group. Comparisons of the episodes of cholangitis, time to the     first episode, and body weight change are made among the three groups.   "
178159|NCT00166881|"     In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (~     60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for     patients with non-resectable gastric cancer. For those patients who have achieved complete     response (CR) or partial response (PR), DI will be used to consolidate the remission. For     those patients who fail to achieve remission by P-HDFL, DI will be used as salvage     chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in     this prospective study.   "
178160|NCT00166894|"     The aim of this trial is to evaluate the level of TREM-1 in different kinds of pleural     effusion.   "
178161|NCT00166907|"     The specific aims of this research are delineated as the following: Aim 1: To investigate the     neuromuscular and biomechanical mechanisms of the emerging processes of proactive and     reactive balance control during sitting and standing in patients with stroke at different     stages of the recovery course. Aim 2: To determine the relationships between brain lesion     sites and the recovery patterns of reactive and proactive balance control mechanisms in     patients with stroke. Aim 3: To determine the relationships between the impairments in     reactive and proactive balance control mechanisms and functional outcome as well as fall     incidence in patients following stroke. Aim 4: To investigate the efficacy of different     training regimens in improving reactive and proactive balance control strategies and in     preventing falls in stroke patients with different brain lesion sites. Principally, three     hypotheses are to be tested: Hypothesis 1:The emerging processes and recovery patternes of     proactive and reactive balance control may be different among stroke patients with different     brain lesion locations. Hypothesis 2:There are positive correlations between the level of     impairments in reactive and proactive balance control mechanisms and functional outcome as     well as fall incidence in patients following stroke. Hypothesis 3:Training regimens that     could best facilitate the emergence or improvement in reactive and proactive balance control     strategies are different.   "
178162|NCT00166920|"     All images in this study were acquired on a 1.5 T Sonata whole body scanner (Siemens Medical     Inc., Erlangen, Germany) using 2D multi-echo gradient echo/spin echo sequence and 2D     single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility     contrast medium. The quantitative estimates and mapping of cerebral metabolic rate of oxygen     utilization were calculated and plotted in all subjects.   "
178163|NCT00166933|"     There is no previous study on the minimal erythema dose of UVB irradiation in Chinese people.     We will investigate the correlation of skin phototype, constitutive skin color, facultative     skin color and minimal erythema dose in Taiwanese.   "
178164|NCT00166946|"     We popose that arsenic-induced lymphocytes dysfunction plays an important role in biological     mechanisms of arsenical Bowen’s disease.   "
178165|NCT00166959|"     The purposes of this study are to investigate the reliability and validity of the modified     Postural Assessment Scale for Stroke Patients (mPASS) and its applications in early detection     of fall-prone patients.      The intraclass correlation coefficient will be used to examine the intra-rater reliability,     inter-rater reliability, and the Cronbach’s alpha will be used to examine the internal     consistency of the 16 items of mPASS.   "
178166|NCT00166972|"     Our study established a model combine the in silico biology and empirical methods to identify     clinically useful biomarker from information of microarray gene expression profiles in public     domain. Through this method, we found trophinin as a novel prognostic marker for early stage     lung cancer, which provide insight towards the process of cancer metastasis and the potential     target for treatment.   "
178167|NCT00166985|"     Adenocarcinoma of the endometrium is the fourth most frequent cancer in women. Surgery is the     treatment of choice in patients with noninvasive or locally advanced disease. The surgical     technique consists of an exploratory laparotomy, with total hysterectomy, bilateral     oophorectomy, peritoneal washing, and, in selected high-risk patients, omental and peritoneal     biopsies and lymphadenectomy. Therefore, preoperative clinical and instrumental staging of     the local spread of disease, as well as local and distant lymph node involvement, represent a     critical step in tailoring the extent and the radicalness of surgery.      The role of angiogenesis in cancer growth and metastasis has been gaining much attention for     decades. Recent clinical evidence supports this notion. The gradual increase in angiogenesis     intensity with tumor progression in malignant melanoma has been reported. Abulafia et al.     reported that increasing angiogenicity could be noted from simple hyperplasia, complex     hyperplasia, atypical hyperplasia, and Stage IA endometrial carcinoma to invasive endometrial     carcinoma. The investigators' research team has shown that incremental angiogenesis could be     demonstrated in the tumorigenesis and the possibility of lymph node metastasis in endometrial     malignancy. Besides, other growth factors such as vascular endothelial growth factor (VEGF),     transforming growth factor- (TGF-), IL-6 and IL-8 have also been reported to correlate with     the angiogenesis and the metastasis of endometrial cancer. It seems that tumor angiogenesis     of endometrial cancer could be utilized as an important parameter to assess the disease     severity of the endometrial cancer.      So, the investigators would like to propose this proposal to focus on the tumor angiogenesis     in endometrial cancer patients. There are several purposes in this study. First, the     investigators will evaluate and compare tumor angiogenesis surveyed from functional MRI and     power Doppler sonography in endometrial cancer patients who receive surgery. Second, the     investigators will evaluate whether tumor angiogenesis could be a marker to predict the     disease severity of endometrial cancer. Third, the role of functional magnetic resonance     imaging (MRI) in endometrial cancer will be elucidated.   "
178168|NCT00166998|"     Breast cancer can cause focal temperature increase on the breast skin due to vasodilatation     mediated by NO secretion from cancer cells. Our study is to evaluate this situation and to     assess the diagnostic efficacy of infrared imaging (thermography)on breast cancer.   "
178176|NCT00167102|"     The purpose of this study is to examine prospectively the safety and efficacy of alefacept in     the treatment of subjects with severe alopecia areata of the scalp. Common features between     psoriasis and alopecia areata, including immunologic and therapeutic aspects, suggest that     alefacept, which has been shown to be a safe and statistically significant beneficial     therapeutic modality for the treatment of psoriasis, may have therapeutic value in alopecia     areata.   "
178177|NCT00167115|"     The hypotheses to be tested are 1) the use of alcohol in the form of wine with the evening     meal will lower plasma glucose during the night and result in lower fasting plasma glucose     the next morning; 2) the chronic use of alcohol in moderation in the form of wine will have     beneficial effects on plasma lipids in type 2 diabetic subjects.   "
178178|NCT00167128|"     In the management and remediation of students with specific performance deficits in     speech-in-noise intelligibility, most often, a triad approach for treatment is used, which     includes direct therapy, compensatory strategies, and environmental modifications.      The purpose of the study is to determine whether a new hearing aid, the Phonak EduLink-FM     System, can improve specific performance deficits in speech-in-noise intelligibility.     Participants will complete a test battery related to auditory processing, as well as some     psychological tests and questionnaires. One group of participants with specific performance     deficits in speech-in-noise intelligibility will receive the hearing aid for use in school; a     second group will not. The effect of this treatment on auditory performance, school     performance and satisfaction, attention and verbal learning and memory, self concept,     behavior and listening effort following 26 weeks of hearing aid use will be compared across     the groups.   "
178179|NCT00167141|"     Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive     in order to investigate whether there are differences between normal and subnormal men in     terms of suppressibility, rate of azoospermia and reversibility of suppression of     spermatogenesis.   "
178180|NCT00167154|"     The purpose of this trial is to investigate the efficacy of risperidone as an adjunct to an     antidepressant treatment in the acute management of suicidality during an episode of major     depressive disorder.   "
178181|NCT00167167|"     In this study our hypothesis is that infusion of donor lymphocyte immune cells from the     subject's bone marrow donor will activate the subject's immune system to attack their cancer.   "
178182|NCT00167180|"     The purpose of this study is to test the hypothesis that a pre-infusion preparative regimen     of cyclophosphamide and fludarabine will improve the effectiveness of DLI in patients with     blood cancers.   "
178183|NCT00167206|"     The purpose of this study is to determine whether thymic shielding during total body     irradiation can be given and whether it will reduce the risk of infections in Fanconi Anemia     patients undergoing alternate donor (not a matched sibling) stem cell transplants.   "
178184|NCT00167219|"     The investigators hypothesize that long-term disease-free survival (DFS) in patients with     JMML can be achieved with a treatment of busulfan (BU), cyclophosphamide (CY) and melphalan     (L-PAM) followed by hematopoietic cell transplantation (HCT).   "
178185|NCT00167232|"     The purpose of this study is to see whether naltrexone is safe and useful in preventing     alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of     alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration     (FDA) for the treatment of alcohol dependence. However, the medication was not approved as     yet at the dosage we will use in this study. The dosage we will use for the study (150 mg),     is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike     other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone     will not make you sick if you drink alcohol. Rather, people who are taking this medication     have reported that it helps decrease the pleasure associated with drinking for them. This     study is being conducted because the medication (Naltrexone) has not been well studied in     people with both alcohol and cocaine dependence, so it is still investigational.      We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy,     this may lead to reduced cocaine use. We are also conducting this study to test two different     types of psychotherapy as a method for reducing cocaine and alcohol use. One type of     psychotherapy is designed to help people learn to cope with situations that put them at high     risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy we will use     focuses on strengthening motivation to recover from cocaine and/or alcohol use, and on     developing techniques to handle possible barriers to recovery. We seek to enroll 300 patients     in the study.   "
178186|NCT00167245|"     The primary purpose of this study is to test the effectiveness of topiramate for the     treatment of combined alcohol and cocaine dependence. Topiramate is approved for the     treatment of seizures. It has not been proven to be effective for the treatment of alcohol or     cocaine dependence.   "
178187|NCT00167258|"     The study will evaluate the effectiveness, economic benefits, and costs of voucher     reinforcement for cocaine and alcohol abstinence, additional counseling services, and their     combination in a sample of cocaine dependent patients receiving outpatient treatment as usual     in a community clinic.   "
178188|NCT00167271|"     Body worn sensors and the Internet can be used to self-monitor daily behavior and promote a     healthier lifestyle in women with fibromyalgia.   "
178199|NCT00167414|"     The purpose of this study is to evaluate whether radiosurgery, along with standard     chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and     immune response), or hormonal therapy, affects the quality and length of life. The standard     therapy is surgery, radiation therapy, or chemotherapy alone or in any combination. A second     purpose of this study is to determine if the levels of a special type of protein (called     cytokines) found in the blood are related to the quality of life while on this treatment.   "
178200|NCT00167427|"     The purpose of the research study is to evaluate an automated, laser-based technique for     measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.   "
178223|NCT00167726|"     The purpose of this study is to collect longitudinal data on outcomes of neuraxial or     neurolytic procedures in patients with intractable cancer and chronic noncancer pain so that     we may contribute to the growing evidence for or against these therapies and to provide data     for ongoing quality improvement activities.   "
178449|NCT00179439|"     The investigators hypothesize that PSC in children is associated with mutations and     functional changes of the cystic fibrosis (CF) gene.   "
178189|NCT00167284|"     With the advent of managed care, increasing responsibility for the care of patients with     diabetes is being placed on primary care physicians. Evidence exists that physicians are not     meeting established practice guidelines, and outcomes in patients with diabetes are less than     optimal. It is thus the objective of this study to institute a community-based diabetes     education intervention for both physicians and patients to enhance adherence to guidelines     and improve patient outcomes.      We will conduct a chart review (submitted under a separate IRB: #000733) in primary care     practices to determine health status and guideline adherence. Following the chart review,     physician practices will be assigned to one of three groups: physician + patient education,     physician education alone, and usual care. Following the intervention, a repeat chart review     will be conducted. Pre and posttest comparisons will be conducted to examine changes     primarily in glycemic control, quality of life, patient knowledge, and physician adherence to     practice guidelines. Secondarily, we will examine changes in therapeutic intervention, body     mass index, and barriers to diabetes care. We will also examine individual barriers to     diabetes care and their influence on outcomes in this population. The last phase of the study     will encompass a second follow-up visit in which we will examine behavioral factors related     to clinical change and sustainability of the intervention.   "
178190|NCT00167297|"     The purpose of this small open-label trial is to evaluate the feasibility of recruiting     cannabis dependent patients for treatment with Atomoxetine and MIT. The clinical data to date     on Atomoxetine has been limited to children and adults with attention deficit disorder     without co-morbid substance dependence. However, one study estimated that adults with     attention deficit disorder have rates of drug abuse three to four times higher than controls     (Mannuzza S 1998). The study also reported that cannabis and cocaine are most frequently     abused in this population.   "
178191|NCT00167310|"     The purpose of this study is to determine whether the administration of omega-3     polyunsaturated fatty acids, particularly eicosapentaenoic acid (EPA), can be useful both to     reduce coronary artery disease (CAD) risk and illness severity in clinically-stable patients     with schizophrenia (or schizoaffective disorder), major depression or bipolar disorder     (depressed phase) being treated with lipid lowering drugs (e.g., statins).   "
178192|NCT00167323|"     Effective psychosocial interventions for individuals with an alcohol use disorder     co-occurring with a severe mental health problem such as bipolar disorder are lacking.     Treatment engagement, adherence, and retention are a major challenge and crucial to achieving     a favorable outcome. The early phase of recovery is a key period during which an effective     intervention exerts its most significant impact. Our proposed treatment intervention is aimed     at addressing early recovery issues, engagement, and treatment and medication adherence in     bipolar alcoholics.      We propose to develop and refine a theoretically based and procedurally specified individual     adherence therapy intervention for co-occurring alcohol use and bipolar disorder in early     recovery, to develop standardized procedures, methods, and techniques so that treatment is     delivered with a high degree of fidelity and competence, and to test the efficacy of this     intervention through a randomized, parallel-group design comparing this new intervention with     current regular clinical care.   "
178193|NCT00167336|"     This study will develop and refine an observational assessment tool called the Personal     Computer Keyboard Style (PeCKS). When completed this assessment tool will provide researchers     and clinicians with a valid and reliable method to describe computer keyboarding postures and     kinematics.      The proposed study will be divided into two phases. Phase I will be devoted to developing and     refining an instrument, the Pre-PeCKS, into a valid and reliable data gathering observational     tool. In Phase II the Pre-PeCKS will be used to develop a predictive model that can     discriminate between those with and without MSD-UE. The model developed will be used to     select the construction and weighting of the subscales of the final instrument, the PeCKS.      Phase I - PeCKS psychometrics - reliability and validity Specific Aim 1: To evaluate inter-     and intra-rater reliability and the concurrent criterion-related validity of the Pre-PeCKS.      H.1.1 The Pre-PeCKS will demonstrate acceptable reliability for the following tests:      H.1.1a. Intra-rater reliability (stability within one rater) H.1.1b. Inter-rater reliability     (stability across raters) H.1.1c. Test of internal consistency (Cronbach's alpha) (stability     across items)      H.1.2 The Pre-PeCKS will demonstrate good concurrent criterion-related validity - Parameters     selected by raters using the Pre-PeCKS will significantly correlate with biomechanical     measures (VICON™ motion recording and analysis system and force plate):      H.1.2.a. Angles and displacements identified by raters using the Pre-PeCKS will correlate     with angles and displacements measured by the VICON™ motion recording and analysis system;     H.1.2.b. Number of times spent performing actions as specified by raters using the Pre-PeCKS     will correlate with number of times measured by a VICON™ motion recording and analysis     system; H.1.2.c. Level of forceful keying as specified by raters using the Pre-PeCKS will     correlate with levels of forceful keying measured with a force plate under the keyboard.      Phase II - PeCKS psychometrics - diagnostic tool development      Specific Aim 2: To use information gathered using the Pre-PeCKS to develop a diagnostic     instrument that can identify those with and without MSD-UE. The major hypothesis related to     Specific Aim 2 is:      H.2.1. Using information gathered with the Pre-PeCKS and knowing the disease outcome of the     subjects, predictive models can be developed that discriminate between those who do and do     not have MSD-UE.   "
178194|NCT00167349|"     The purpose of this study is to determine if a difference exists in the inflammatory response     which occurs related to coronary artery bypass graft (CABG)surgery performed on     cardiopulmonary bypass as compared to CABG surgery performed off bypass at the University of     Pittsburgh Medical Center.   "
178195|NCT00167362|"     This study will determine the effectiveness of cognitive enhancement therapy (CET) in     treating cognitive abnormalities in people experiencing the early stages of schizophrenia.   "
178196|NCT00167375|"     This study tests a new kind of sleep study in which subjects are awakened 2 times after     initially going to sleep. The study focuses on the EEG signal process as a person goes to     sleep. The general hypothesis is that the signal properties are stable from night to night     during baseline studies, and are different between controls and patients with primary     insomnia. The primary insomnia patients then go on to have about 2 weeks of an insomnia     intervention. Then the new kind of study is repeated in the patients. The controls only are     examined in baseline studies.   "
178197|NCT00167388|"     The purpose of the study is to see if a blood transfusion changes how fast blood flows to the     intestines of a premature baby. Blood flow is measured by an ultrasound test. The     investigators also look to see if the blood flow to the intestines depends on whether the     baby feeds or doesn't feed during the blood transfusion.   "
178198|NCT00167401|"     The University of Rochester Cancer Center (URCC) is conducting a research study at Highland     Hospital and Strong Memorial of lung cancer patients whose tumors cannot be surgically     removed. The usual treatment for this stage of cancer is chemotherapy (treatment with drugs)     combined with radiation (chemo-radiation). Because of the risk of spread to other organs,     patients with your stage of disease are also often treated with additional chemotherapy,     either before or after the chemo-radiation treatment. The best timing and number of     treatments for this additional chemotherapy has not been clearly established. The purpose of     this study is to help determine if a single treatment with two chemotherapy drugs, followed     by radiation and low-dose chemotherapy is an effective way to treat patients with lung     cancer. The side effects of this treatment and your quality of life while on the study will     also be studied. Eighteen will participate in this study locally.   "
178201|NCT00167440|"     Each year in the United States more than 30,000 children are admitted to intensive care     units. The majority of these children have some degree of heart instability during their     stay, yet there is currently no routine way to measure the actual amount of blood that the     heart pumps. The ability to measure the amount of blood that the heart pumps accurately and     easily at frequent intervals would be very helpful to the doctor caring for these children     because many of them have poor heart function as a result of their illnesses. Current     techniques used in adults to measure output of the heart are either not readily transferred     to children or demand difficult invasive procedures. Because of this, the amount of blood     that the heart pumps cannot be measured with enough frequency to help guide care. Despite     this reality, accurate measurements of the amount of blood that the heart pumps in these     patients at crucial points in their illnesses would allow for more accurate use of     potentially harmful procedures and could possibly improve the outlook for these children.     Likewise, being able to correctly measure blood volume could provide a better way to estimate     the pressure on the heart and improve treatment.      The purpose of this research study is to compare the accuracy of doctor estimates of heart     output, and establish the usefulness of central blood volume measurements by PCOM (pediatric     cardiac output measurements), a less invasive procedure   "
178202|NCT00167453|"     The research outlined in the BEEP proposal aims to test whether a 12 week exercise program     alone or combined with a 12 session education program will benefit the physical, emotional     and social well being of individuals in early to mid stages of Parkinson's Disease compared     to a Control group and whether these benefits are maintained once the programs are complete     and over the following 9 months.   "
178203|NCT00167466|"     The effects on indices of gingivitis/periodontitis will differ between study arms in which     the titanium dioxide semiconductor toothbrush is used, compared to an otherwise identical     toothbrush with an inert resin core in place of the titanium dioxide semiconductor.   "
178204|NCT00167479|"     The specific aim of this study is to evaluate the efficacy, tolerability, and safety of     risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid     lifetime panic disorder or generalized anxiety disorder and current at least moderately     severe anxiety.   "
178205|NCT00167492|"     The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our     usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to     find out the effect this change may have on the development of side effects such as relief of     gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current     drug) because of these side effects. We will also try to see if improved usage of this drug     (Myfortic®) will allow us to use lower doses of other medications that lower your immune     system. We will do some special tests on your blood to see if the amount of the drug is     related with its effect on the immune system and side effects. Both Cellcept and Myfortic®     are FDA approved medications although Myfortic® is not approved for use after liver     transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid)     but has been coated to prevent breakdown of the drug in the stomach and is made to lower the     known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea.   "
178206|NCT00167505|"     This study will evaluate the efficacy of two curricula relative to standard care. The first     is a sexual risk avoidance curriculum for middle school students that included abstinence     until marriage and complies with Title V Section 510 A-H abstinence education requirements.     The second is a sexual risk reduction curriculum for middle school students that included     abstinence and condom/contraceptive information and skills. Each intervention consists of an     age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in     7th and 8th grade. The overall goal of the study is to identify common elements of effective     sexuality education curricula that will be of benefit to youth.   "
178207|NCT00167518|"     The trial will test the hypothesis that an intravitreal injection of triamcinolone is safe     and efficacious for patients with clinically significant diabetic macular oedema that is     recalcitrant to conventional laser therapy   "
178208|NCT00167531|"     Being able to walk is a major determinant of whether a patient returns home after stroke or     lives in residential care. For the family, the loss of the stroke sufferer from everyday life     is a catastrophic event. For the community, the costs of being unable to walk after stroke     are exorbitant, involving a lifetime of residential care. Therefore, an increase in the     proportion of stroke patients who regain walking ability will be a significant advance.      This trial will determine, in patients early after stroke who are unable to walk, whether     training walking using a treadmill with partial weight support via an overhead harness will     be more effective than current intervention in (i) establishing more independent walking,     reducing the time taken to achieve independent walking, and improving the quality of     independent walking, and (ii) improving walking capacity and participation 6 months later.   "
178209|NCT00167544|"     The purpose of this study is to determine whether treatment of very preterm infants at     high-risk for lung and brain injury with low dose hydrocortisone results in improved     pulmonary and neurologic outcomes.   "
178210|NCT00167557|"     After a liver transplant, the hepatitis C virus (which destroyed one's own liver) eventually     comes back. In many patients, this will eventually cause the loss of the new liver and can     also confuse the doctors taking care of them because it is hard to tell the difference     between one's body rejecting the new liver and hepatitis. This can cause serious treatment     errors that can lead to more severe hepatitis or to rejection of the liver. Some of the drugs     used to prevent rejection of one's new liver can cause the hepatitis to come back in a more     severe form. This is especially true for the drugs known as corticosteroids.      Right now, the only effective treatment against hepatitis C is a combination of two drugs     called interferon and ribavirin. These drugs act by strengthening one's immune system to     fight the virus and by directly reducing the reproduction of the virus. Because the treatment     with these drugs is associated with many side effects, there is little experience with     treating patients after liver transplantation with them.      In the investigators' transplant program, they have decided to treat all patients with     hepatitis C as early as possible after transplantation and to follow them closely for the     development of hepatitis and side effects of the treatment. The investigators treat one's     hepatitis as early as possible, before any actual damage has occurred in the new liver. This     approach has been tried before but it has been hard to tell if it has worked or not. The main     reason for failure was that many patients could not complete the treatment due to side     effects. The investigators' purpose is to treat those side effects aggressively so that most     patients can complete the treatment course.      The purpose of this study is to collect all the data regarding the investigators' treatment     protocol so that they will be able to learn if this form of treatment is beneficial.      The study includes performing liver biopsies at scheduled times after one's liver transplant     and for scheduled blood tests to see how much virus is still in the blood. If patients show     signs that they are not responding to treatment they will be removed from the study.   "
178392|NCT00178659|"     The specific aim of this research is to determine if the blood from brain-injured patients     contains reproducible protein markers that appear prior to elevations in intracranial     pressure (ICP).   "
178211|NCT00167570|"     The overall long-term goal of this project is the development of a clinically practical     system for rapid prosthetic limb provision that integrates computer-aided design with solid     freeform fabrication techniques. This proposal builds on our previous successful     demonstration of the feasibility of SFF socket fabrication and will address several key     issues that underlie its clinical viability. The specific objectives of the proposed work     are:        1. To develop improved designs for SFF transtibial prosthetic sockets that allow the use of          industry standard pylon mounts and incorporate variable compliance elements.        2. Determine the clinical effectiveness of variable wall compliance elements in enhancing          the comfort and fit of transtibial prosthetic sockets.        3. Determine the durability and functionality of SFF sockets during extended clinical use.      These objectives will be met over a three-year period. The initial phase of the proposed work     will use an iterative engineering design - modeling - evaluation process to develop variable     compliance elements and an industry standard pylon mount adapter. During the second phase of     the proposed work, clinical evaluations of SFF prosthetic sockets will be studied. The     effectiveness of variable compliant elements in enhancing comfort and fit will be determined     using a within subject case comparison study of SFF sockets with conventional laminated     sockets. Durability of SFF sockets that incorporate an industry standard pylon mounting     system will be determined during a 12-month clinical field trial.   "
178212|NCT00167583|"     The purpose of this study is to investigate if interferon-alpha2a is superior to the standard     treatment with cyclosporin A for the treatment of severe ocular manifestations of Behcet`s     disease.   "
178213|NCT00167596|"     The purpose of this study is to evaluate the usefulness of an optimization of muscle     perfusion and oxygenation, as assessed by the NIRS technique, in critically ill patients with     sepsis.   "
178214|NCT00167609|"     To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with     myotonic dystrophy   "
178215|NCT00167622|"     The purpose of this study is to determine whether early mechanical ventilation can prevent     hospital acquired pneumonia in adults with Guillain Barré Syndrome.   "
178216|NCT00167635|"     The purpose of this study is 1) to determine whether a comprehensive self-management     intervention is effective in a sample that includes men and women with irritable bowel     syndrome, and 2) to determine whether the comprehensive self-management intervention is as     effective when delivered over the telephone as compared to a face-to-face approach.   "
178217|NCT00167648|"     Prostate cancer is the most commonly diagnosed cancer among males in the U.S. More than     220,000 men will be diagnosed with prostate cancer in the USA this year and more that 31,000     will die of this disease.      Androgen deprivation, the elimination of testosterone and its active metabolites, remains the     single most effective intervention available for the treatment of advanced prostate     carcinoma. Androgen deprivation induces an immune response to normal prostate and prostate     cancer, which is usually short-lived. Estradiol induces activation of many arms of the immune     system and may be a more effective and long lasting means of inducing immunity to prostate     tissue.      This study will treat clinically localized prostate cancer patients with either estrogens, or     standard androgen deprivation without estrogens, prior to prostatectomy in order more     completely to describe immune regulation by estradiol in men. Control tissue from patients     who have not been treated with androgen deprivation will be procured from the Northwest     Special Projects in Oncology Research Excellence (SPORE) tissue core and used as comparisons     against the cancers treated before prostatectomy. Tumors removed at prostatectomy, tissue     samples and blood samples will be assessed for immune system changes.   "
178218|NCT00167661|"     The purpose of this study is to determine whether Campath-1H induction and the associated     lymphocyte depletion will permit long-term rejection-free renal allograft survival in the     absence of ongoing corticosteroid administration.   "
178219|NCT00167674|"     Identifying new approaches for preventing breastmilk transmission of HIV-1 is an important     research priority. To this end, clinical trials are underway to evaluate the efficacy of     HAART (zidovudine, lamivudine, nevirapine) during late pregnancy/lactation versus     zidovudine/nevirapine peripartum for prevention of breastmilk HIV-1 transmission. It is     important to understand the mechanism of effect of these antiretroviral (ARV) strategies on     prevention of breastmilk HIV-1 transmission.      This phase II trial will compare HAART vs peripartum zidovudine/nevirapine for effect on     breastmilk HIV-1, breastmilk HIV-1 specific immune responses, and infant HIV-1 specific     immune responses.      100 pregnant HIV-1 seropositive women in Nairobi with CD4 counts between 200 to 500 who have     chosen to breastfeed will receive either ARV regimen. Mother-infant pairs will be followed     for 1 year after delivery. Home visits will be conducted in the first month (~10 visits) to     collect 2-5 mls of breastmilk per visit. Mother-infant pairs will be seen in the study clinic     with maternal blood and breastmilk and infant blood collected at months 1, 3, and 6 for HIV-1     and HIV-1 Elispot assays. Breastmilk HIV-1 RNA and DNA levels will be quantified in Dr.     Overbaugh's laboratory in Seattle and Elispot assays conducted in Nairobi with validation of     a subset in Dr. Rowland-Jones laboratory in Oxford. Viral loads, decay curves, half-life, and     re-population following ARV cessation will be estimated for each regimen and regimens     compared. These studies will provide insight into the viral and immune responses to ARV     regimens proposed for prevention of breastfeeding HIV-1 transmission and will be important     for rational design of future interventions. After taking into account, estimated loss to     follow-up, the targeted sample size with outcome data was 80 women, 40 in each trial arm,     estimating undetectable breast milk HIV-1 RNA levels in the HAART arm and median breast milk     HIV-1 RNA levels of 3.0 log10 in women receiving ZDV/NVP.   "
178220|NCT00167687|"     This double-blind placebo controlled pilot trial will test the hypothesis that prazosin, an     alpha-1 adrenergic receptor antagonist, reduced alcohol consumption and alcohol craving in     alcohol dependent individuals without Post Traumatic Stress Disorder (PTSD). The intervention     period is six weeks.   "
178221|NCT00167700|"     Combined programme: Nutrition, Allergy, Mucosal immunology and Intestinal microbiota (NAMI)     was created with the objective to reverse the rising trend of chronic inflammatory diseases,     such as allergic disease and obesity, by control of the internal and external environments of     the infant. To approach this problem, the project aims to characterize        -  how immunology is regulated during pregnancy and early infancy,        -  how the immune interaction between mother and child is influenced by nutritional and          microbial factors, and        -  how the regulation is related to disease risk.   "
178222|NCT00167713|"     Drugs to treat fever are widely used in children with fever. But there is a controversy about     the benefit of reducing fever in children with malaria. Ibuprofen is often used to treat     malarial fever. This study evaluates the capacity of ibuprofen to reduce fever in malaria.     The effect of ibuprofen on fever compared to only mechanical measures is investigated in     children with malaria.   "
178416|NCT00178984|"     The purpose of this study is to use the Squid magnetometer (Superconducting QUantum     Interference Device) to help diagnose electrical and mechanical abnormalities of the stomach     and intestines.   "
178224|NCT00167739|"     Quinine remains the treatment of choice of hospitalised malaria cases. The long treatment     duration of 7 days, and adverse reactions often hamper its adequate use. Reducing the     treatment duration by adding sulfadoxine-pyrimethamine may enhance compliance and reduce side     effects.      The efficacy of a 3-day treatment of quinine plus sulfadoxine-pyrimethamine for the treatment     of hospitalised, uncomplicated malaria cases was assessed.   "
178225|NCT00167752|"     The purpose of this study is to investigate the prevalence of depression, anxiety, and sleep     problems in patients with chronic skin diseases in dermatology clinics at the University of     Wisconsin Hospital and Clinics.   "
178226|NCT00167765|"     The purpose of the prospective, randomized, double blind, placebo-controlled multicenter     pilot study is to evaluate the effectiveness of abciximab on rescuing the hypoperfused brain     tissue, as assessed by MRI, and the relative safety of abciximab in patients with wake-up     stroke.   "
178227|NCT00167778|"     The biomechanics of changing direction while walking has been largely neglected despite its     relevancy to functional mobility. In addition, an increased risk of injury can be associated     with turning due to a decrease in stability. The objective of this study is to understand the     biomechanics of turning gait in sample populations of intact and trans-tibial amputees and     the capacity of prosthetic components to facilitate transverse plane movement. The clinical     impact of this investigation is the development of interventions that increase functional     mobility, stability and safety while turning.      The researchers propose to investigate three sets of hypotheses. The first set addresses the     fundamental biomechanical mechanisms associated with walking along a circular trajectory, how     intact subjects differ from amputees, and the effect of a rotation adaptor pylon. The second     set of hypotheses addresses dynamic stability and the potential influence of prosthetic     interventions. The third set of hypotheses addresses how the rotational properties of the     prosthetic pylon can influence comfort and mobility during daily activities.   "
178228|NCT00167791|"     This is a study of patients who have a high risk of kidney rejection before kidney     transplant. The hypothesis is that treatment with a medication called rituximab will make it     possible for them to receive a kidney transplant from a donor who previously did not present     a good match.   "
178229|NCT00167804|"     Combat related Posttraumatic Stress Disorder (PTSD) is the most common chronic psychiatric     disorder in the veteran population. Unfortunately, outcome studies of VA PTSD programs have     failed to show efficacy. VA PTSD patients have been significantly less responsive to     conventional therapies than other PTSD populations. Virtual Reality based exposure therapy     (VRE) allows patients to feel immersed in highly interactive computer-generated environments.     Within these environments patients can be exposed to anxiety-provoking stimuli in a gradual     and controlled manner so that they can become desensitized to these stimuli and, in the case     of PTSD, the traumatic memories evoked by these stimuli. The advantages of VRE include less     reliance on the patient's ability to visualize traumatic memories and making it more     difficult for patients to avoid memories during exposure therapy. It is also safer and more     convenient than in vivo exposure. In this study twenty Vietnam veterans are randomly assign     to either VRE or to a Treatment as Usual (TAU) control condition. Treatment would consist of     ten ninety-minute individual psychotherapy sessions for both groups. Assessments would occur     at pre-treatment, immediate post-treatment and at six months post-treatment.   "
178230|NCT00167817|"     Patients with schizophrenia are much more likely to be engaged in smoking and other addictive     behaviors, possibly related to biochemical abnormalities in the reward center of the brain.     The primary purpose of the present study is to investigate whether switching patients with     schizophrenia to a new atypical antipsychotic, aripiprazole, a drug with a novel mechanism of     action, will have an impact on smoking behavior.   "
178231|NCT00167830|"     The purpose of this study is to identify significant racial and ethnical differences in risk     factors for development of obesity and weight loss in adolescents in Central Virginia   "
178232|NCT00167843|"     The general goal of the project is to assess the infectious status and immunity of mothers     and children living in a malaria region. A major part of the study involves administering an     effective antimalarial, sulfadoxine-pyrimethamine (Fansidar®), to children at the same     timepoints as vaccinations, i.e. at age 3, 9 and 15 months. The main objective is to study     safety, efficacy, and consequences of such a strategy in particular the ability to reduce the     risk of anemia.   "
178233|NCT00167856|"     The purpose of this study is to evaluate the pain-relieving effects of venlafaxine     hydrochloride (Effexor) in chronic neuropathic (burning, shock-like, electric) pain after     spinal cord injury (SCI). Although a number of medications have been used to treat SCI pain,     no drug has been consistently helpful, and, therefore, many people with SCI continue to have     difficult chronic pain. Venlafaxine is a new anti-depressant drug that has not been tested     for use in SCI neuropathic pain, but has been helpful for other types of neuropathic pain.   "
178234|NCT00167869|"     Hypertension is an increasingly important medical and public health issue. Literature     suggests that there may be a role for dairy foods in the prevention and treatment of     hypertension. Recently, it has been suggested that several peptides in milk proteins could     have blood pressure lowering properties. LACTOPRES is a randomised, double-blind parallel     trial to assess the blood pressure effect of an increased intake of dairy peptides in humans.   "
178235|NCT00167882|"     The purpose of this study is to determine the influence of different 5-aminosalicylate     concentrations on the metabolism of azathioprine or 6-mercaptopurine in patients with     inflammatory bowel disease.   "
178236|NCT00167895|"     The objective of this study is to evaluate the effect of autologous platelet concentrate on     blood loss (post-operative decrease of haemoglobin concentration), wound healing     complications, range of motion, pain reduction and outcome scores when used in total knee     arthroplasty.   "
178249|NCT00176475|"     RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may     help the patient's immune system kill cancer cells. Monoclonal antibodies, such as rituximab,     can block cancer growth in different ways. Some block the ability of cancer cells to grow and     spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. Giving irradiated donor lymphocytes together with rituximab may kill more cancer cells.      PURPOSE: This clinical trial is studying the side effects and how well giving irradiated     donor lymphocytes together with rituximab works in treating patients with relapsed or     refractory lymphoproliferative disease.   "
178237|NCT00176319|"     In both ageing and heart failure progressive exercise intolerance is observed. The Leipzig     Exercise Intervention in Chronic heart failure and Aging (LEICA) study aims to investigate     how aerobic short-term training interventions affect exercise capacity, left ventricular     systolic and diastolic function, biomarkers of heart failure, skeletal muscle metabolism, and     endothelial function in chronis heart failure patients (CHF-patients) and healthy subjects     (HS) in two different age strata: Above 65 years and below 55 years.      Aim of the trial is therefore to compare the effects of aerobic exercise training in young     and old healthy subjects as well as in young and old heart failure patients. To our knowledge     this study is the first to prospectively investigate age differences of training responses in     both CHF patients and age-matched healthy controls.      Because of the extensive clinical and molecular assessment the results of this trial will be     made public in predefined substudies:        -  LEICA-Echo        -  LEICA-Biomarkers        -  LEICA-Endothelium        -  LEICA-Cardiopulmonary Exercise Function        -  LEICA-Muscle   "
178238|NCT00176332|"     Statin therapy has been shown to efficiently reduce mortality in patients with coronary     artery disease and myocardial infarction, partially as a result of the lipid-lowering     properties of statins. However, especially the pleiotropic effects of statins, e.g. their     anti-inflammatory and anti-oxidative properties, might be of interest in the treatment of     patients with chronic heart failure that are limited in their exercise capacity due to     alterations of the skeletal muscle and peripheral endothelial dysfunction.      Aim of this trial is therefore to assess the effects of three months of rosuvastatin     treatment on markers of inflammation and oxidative stress in the skeletal muscle and the     blood, on postnatal vasculogenesis, and endothelial function of the radial artery in patients     with severe chronic heart failure.   "
178239|NCT00176345|"     Bradykinin has been identified to contribute to the release of nitric oxide (NO),     prostacyclin, and EDHF through activation of specific bradykinin 2 (B2) receptors, which is     finally promoting a vasodilatory respone. Regular physical exercise training results in an     improvement of endothelial function in patients with CAD. These positive effects were     partially attributed to an increased expression of endothelial NO synthase (eNOS) and     cyclooxygenase (COX) as a result of the training intervention.      Aim of this trial is therefore to determine, whether the training-induced correction of     endothelial dysfunction is also bradykinin-dependent.   "
178240|NCT00176358|"     The purpose of this study is to compare coronary angioplasty with stent implantation with an     exercise rehabilitation program in patients with stable coronary artery disease (CAD).   "
178241|NCT00176371|"     There is an increasing incidence of overweight children in Germany, due to a lack of physical     activity.      The aim of this study is to improve physical fitness and activity in school children. Two     classes in different schools are provided with additional sport lessons over a period of one     year.   "
178242|NCT00176384|"     Patients with heart failure are limited in their exercise capacity due to skeletal muscle     alteration and an impairment of peripheral perfusion. Regular physical exercise training has     been shown to partially correct these peripheral maladaptations in patients with stable heart     failure, which was associated with an improvement in exercise capacity. However, it is     unknown so far, whether regular physical activity also exerts beneficial effects in patients     with severe chronic heart failure.      Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise     capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic     heart failure according to NYHA class III b.   "
178243|NCT00176397|"     Recent technical advances in percutaneous coronary interventions have made it possible to     approach patients with coronary lesions formerly considered to be classical candidates for     bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear     whether the good long-term results achieved with the surgical therapy can be reproduced by an     interventional strategy using drug-eluting stents (DES).      The aim of the current trial is, therefore, to compare the clinical and angiographic results     of PCI and CABG in patients with left main coronary stenosis.   "
178244|NCT00176410|"     There is evidence that the degenerative changes leading to aortic stenosis are caused by a     chronic inflammatory process. Furthermore the development of aortic stenosis is partially     dependent on typical cardiovascular risk factors. An inflammatory process as well as those     risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase     inhibitors) would be an appealing concept to reduce both those risks for development of     aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the     progression of aortic stenosis.   "
178245|NCT00176423|"     The purpose of this study is to examine whether adjunctive galantamine is effective in the     treatment of cognitive impairments in patients with schizophrenia.   "
178246|NCT00176436|"     The study investigates the use of Atomoxetine in combination with exercise and a diet support     group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All     patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective     Disorder.   "
178247|NCT00176449|"     The purpose of this study is to examine whether the adjunctive use of bupropion SR in the     context of a psychoeducational program modified for people with schizophrenia might improve     the likelihood of successful abstinence in this population. If bupropion SR is effective for     reducing cigarette smoking, then it will be important to determine if decreased nicotine     intake is associated with a worsening of psychotic, anxiety or depressive symptoms. In     addition, it would be important to determine the effect that a reduction in nicotine     stimulation would have on patient's cognitive functioning, as nicotinic receptors have been     shown to regulate attention and memory function, and it is hypothesized that these functions     are normalized by acute nicotine administration in people with schizophrenia   "
178248|NCT00176462|"     The purpose of this research study is to identify better ways to treat children and young     adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define     methods to identify those patients at higher risk for certain side effects, as well as those     who are at higher risk for relapse of their leukemia.   "
178268|NCT00176995|"     This trial is designed to gain insight into the mechanism of action of eflornithine     hydrochloride in men and to aid in determining if this compound is deserving of further     development for a pseudofolliculitis barbae indication. This study will also provide     knowledge which will be useful in designing future PFB trials in this indication is pursued.   "
178250|NCT00176488|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin and vinorelbine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving epirubicin together with vinorelbine may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving epirubicin together with vinorelbine     works in treating patients with stage II, stage III, or stage IV breast cancer.   "
178251|NCT00176501|"     RATIONALE: When irradiated donor lymphocytes are infused into the patient they may help the     patient's immune system kill tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving irradiated     donor lymphocytes works in treating patients with metastatic kidney cancer.   "
178252|NCT00176514|"     This is a clinical research study that is designed to determine if there is a potential     benefit of green tea to help treat and prevent therapy induced mucositis, which is mouth     sores caused by chemotherapy.   "
178253|NCT00176527|"     RATIONALE: Isotretinoin may help prostate cancer cells become more like normal cells, and to     grow and spread more slowly. Interferon alfa-2b may interfere with the growth of tumor cells.     Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alfa-2b     together with docetaxel and estramustine works in treating patients with metastatic prostate     cancer that did not respond to hormone therapy.   "
178254|NCT00176540|"     RATIONALE: Dextromethorphan may help relieve fatigue in patients with cancer.      PURPOSE: This clinical trial is studying how well dextromethorphan works in treating patients     with fatigue caused by cancer.   "
178255|NCT00176553|"     The purposes of this study are to find out whether dextromethorphan can prevent the short or     long-term neurologic side effects of methotrexate, and whether dextromethorphan can improve     symptoms of short-term neurologic side effects if they do occur.   "
178256|NCT00176566|"     You have been asked to participate in this research study because you have or may have oral     leukoplakia. Oral leukoplakia is described as a white patch or plaque on the oral mucosa     (mouth) that will not rub off and cannot be removed by scraping, reversed by elimination of     obvious irritants (things that cause redness and/or swelling) such as dentures (artificial     replacment for missing teeth), or lesions as described that are diagnosed by your dentist.   "
178257|NCT00176579|"     RATIONALE: Measuring bone mineral density may help doctors predict whether prostate cancer     will come back. It may also help the study of prostate cancer in the future.      PURPOSE: This clinical trial is studying whether bone mineral density affects cancer     recurrence in patients with early stage prostate cancer.   "
178258|NCT00176592|"     This is the first comparison of efficacy of Betaseron and Copaxone for treatment of relapsing     forms of MS.   "
178259|NCT00176605|"     Based on data supporting the use of cyclophosphamide and etoposide both as single agents in     combination and a Phase I study showing acceptable toxicity with a chronic dosing regimen, we     propose a Phase II clinical trial. This protocol establishes a model that will test the     hypothesis that the use of etoposide and cyclophosphamide early in the course of prostate     cancer progression, when fewer tumor cells are present, will have greater anti-tumor     activity. We plan to treat patients with stage D0 prostate cancer to assess toxicity and     anti-tumor activity.   "
178260|NCT00176618|"     The purpose of this study is to determine the effectiveness of curcumin in reducing the     number of aberrant crypt foci (ACF) in the colon.   "
178261|NCT00176631|"     RATIONALE: Licorice root extract contains ingredients that may slow the growth of tumor     cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     licorice root extract together with docetaxel may be an effective treatment for prostate     cancer.      PURPOSE: This phase II trial is studying the side effects and how well giving licorice root     extract together with docetaxel works in treating patients with metastatic prostate cancer     that did not respond to hormone therapy.   "
178262|NCT00176644|"     Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer,     and most recently trials have supported the use of transdermal estrogens (patch) in the     patient population with a decreased risk of cardiovascular disease as compared to the oral     estrogens. We plan to study the use of transdermal estrogen at a dose of 0.4mg qd. We will     evaluate the toxicities and measure quality of life. We will assess PSA response and     measurable disease response. This will be a trial available to the Cancer Institute of New     Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at     CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic     evaluations every three weeks. We will assess quality of life through a questionnaire given     to patient every three weeks.   "
178263|NCT00176930|"     The purpose of this study is to develop a standard of care treatment using allogeneic stem     cells for patients with cancers of the blood.      The protocol was revised to reflect that this study is considered treatment guidelines,     rather than a research study.   "
178264|NCT00176943|"     It is thought that alopecia areata occurs as the result of an inappropriate response of the     body's own immune system to certain substances in or around the hair follicle. We will be     examining the efficacy of Aldara Cream 5% in treating extensive alopecia areata and observe     its affect on the hair follicle.   "
178265|NCT00176956|"     The skin disease found in pediatric heart transplant patients represents an atopic     dermatitis-like rash that is refractory to systemic immunomodulation.   "
178266|NCT00176969|"     It has been postulated that Alopecia Areata (AA) is, at least in part, a neurologically     mediated disease. Research supporting this theory includes the finding that nerves     surrounding the hair follicles are collapsed. We want to take this research a step further     and show that not only are these perifollicular nerves collapsed, but that their function is     also impaired.   "
178267|NCT00176982|"     Alopecia areata is an autoimmune condition resulting in hair loss and complete baldness     (alopecia totalis). Published evidence says that it is mediated by T-lymphocytes. Plaquenil     is an anti-inflammatory drug approved by the FDA for malaria, lupus erythematosus, and     rheumatoid arthritis. It has an effect on T-lymphocyte mediated inflammation, making it a     logical choice for a treatment trail for alopecia areata.   "
178269|NCT00177008|"     This study will determine the efficacy of a medication switch to Aripiprazole for the     treatment of schizophrenia or schizoaffective disorder in patients with moderate to high     symptoms of social anxiety. Specifically the study will test the possibility that a     medication switch to Aripiprazole reduces symptoms of social anxiety in this patient     population.   "
178270|NCT00177021|"     We propose to examine the efficacy and tolerability of Aldara Cream 5% for the treatment of     extensive alopecia areata. Aldara is a immune-response modifier. The drug induces the     production of cytokines which are small, hormone-like proteins involved in cellular     communication during immune responses. We hypothesize that this drug will effect the     inflammatory cells present around hair follicles in patients with alopecia areata.   "
178271|NCT00177034|"     The keratinocytes of lesional skin of vitiligo compared to normal and perilesional skin will     differentially express genes correlating with melanocyte death. Narrow Band UVB should then     hopefully reverse the pattern of gene expression back toward normal.   "
178272|NCT00177047|"     This is a study of a regimen of melphalan and autologous stem cells for patients with     multiple myeloma. We hypothesize that this particular regimen will improve the survival of     these patients.   "
178273|NCT00177060|"     The hypothesis is that topical opioids will hasten wound healing in humans.   "
178274|NCT00177086|"     This study will assess improvement in the percentage of spontaneous stone passage for distal     ureteral calculi for alfuzosin compared to placebo, decrease of pain and narcotic/analgesic     use associated with stone passage, decrease of the time to spontaneous stone passage, shift     in the size distribution of stones passed towards larger sizes.   "
178275|NCT00177099|"     The purpose of this study is to determine if immunophilin ligands may have the potential to     reverse hair loss.   "
178276|NCT00177112|"     The purpose of this study is to verify that the incidence rate of urinary tract infections     after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile     procedural techniques.   "
178277|NCT00177125|"     The purpose of this study is to perform a randomized prospective study to evaluate whether     the vacuum erection device facilitates an earlier return of erectile function post radical     prostatectomy. A secondary measure will be to evaluate if the vacuum erection device can help     prevent penile shortening.   "
178278|NCT00177138|"     This is a single center, prospective, open-label, randomized trial at the University of     Minnesota Medical Center,Fairview.      Primary objectives are to determine if rejection episodes and loss rates, graft survival,     level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1)     immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin,     tacrolimus, and MMF (Group 2).      This study will investigate the first protocol that is both steroid-free and calcineurin     inhibitor-free in pancreas after kidney transplant recipients.   "
178279|NCT00177164|"     We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who     were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in     the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments.     Patients were titrated and cross-tapered during a 3 month titration and stabilization phase.     They were followed for an additional 12 months. Clinical outcomes such as study drop out,     adverse events, worsening of symptoms, crisis interventions, need for additional medication,     hospitalizations etc. were evaluated from months 3 to 15. The numbers of clinical events     (pooled) will be used to evaluate if the long acting injectable form of risperidone has an     advantage over the oral second generation antipsychotic agents in terms of treatment     continuity and clinical stability.   "
178280|NCT00177177|"     The investigators' hypothesis is that oral L-carnosine treatment (as compared with placebo)     will enhance cognitive abilities (specifically: measures of attention, executive function,     working memory, visuospatial ability and language) in persons with schizophrenia or     schizoaffective disorder. Secondarily, they hypothesize that there will be secondary     improvements in positive, negative and mood symptoms with L-carnosine treatment.      The investigators aim to test these hypotheses by conducting a randomized, placebo     controlled, add-on treatment trial of L-carnosine (added to existing antipsychotic treatment)     up to 84 recruited subjects with Diagnostic and Statistical Manual of Mental Disorders, 4th     Edition, Text Revision (DSM-IV-TR) schizophrenia/schizoaffective disorder for a period of 16     weeks. Measures of cognition and psychopathology will be utilized for evaluating primary and     secondary outcomes, along with safety assessments.   "
178281|NCT00177190|"     This is an in vitro evaluation of cutaneous T-cell lymphoma using patients' blood and tissue     to evaluate immune responses related to identified tumor populations and dendritic/CD 8     cells.   "
178282|NCT00177203|"     This project will test the efficacy of a brief, 2 session behavioral intervention for     insomnia, as compared to an information-only condition. We hypothesize that compared to those     receiving the information-only intervention, those assigned to BBTI will have superior     short-term outcomes and retain the gains made, at 12 months.      We will also compare older insomniacs to age matched good sleepers through measurers of     mental and physical health, sleep, and general functioning. We hypothesize that the insomnia     cohort will have more physical and mental health disorders of a greater severity than the     age-matched controls.   "
178283|NCT00177216|"     This study will compare the symptoms, experiences, and laboratory sleep characteristics of     young adults with and without insomnia.   "
178284|NCT00177229|"     The purpose of this study is to determine if a family based diet and exercise program is     helpful for extremely overweight children aged 8-12, and to compare this approach to standard     medical management of severe pediatric obesity.   "
178285|NCT00177242|"     This is a phase II, open-label trial of Gefitinib and docetaxel in patients having one prior     regimen of chemotherapy for with metastatic pancreatic carcinoma.   "
178286|NCT00177255|"     This is a phase II study that will investigate weekly dosing of docetaxel in combination with     capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.   "
178287|NCT00177268|"     This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL),     eczema, and atopic dermatitis patients for current and future research.   "
178417|NCT00178997|"     The purpose of this study is to look at the electrical activity present in healthy and     diseased smooth muscle of the intestines; and develop both mathematical and computer models.   "
178288|NCT00177281|"     The purpose of this research study is to evaluate a new anti-cancer drug called S CKD602,     developed by ALZA Corporation. The drug is investigational and not approved by the Food and     Drug administration (FDA). The side effects (the way the drug acts in your body) and the     effect it has on your disease will be studied.   "
178289|NCT00177294|"     This study will determine whether adding interpersonal psychotherapy to treatment with the     antidepressant escitalopram will be more effective in reducing symptoms of depression than     antidepressant medication alone.   "
178290|NCT00177307|"     This is a Phase II study of the drug combination of Oxaliplatin, Avastin and capecitabine.     This is an open-label study.   "
178291|NCT00177320|"     Computers allow individuals to engage in economic, social, and entertainment activities.     Despite the many benefits of computer use, many individuals with rheumatic diseases may have     difficulty using a computer. However, currently there is almost no information on the     problems individuals with rheumatic diseases experience using a computer. Baseline     information on the types of problems experienced by individuals with rheumatic diseases as     well as the magnitude of those problems is needed before methods can be developed to     intervene and remediate them. In this study we will develop and administer to a     representative sample of patients with rheumatic diseases a survey which will examine the     type and magnitude of computer problems experienced by those with rheumatic diseases. The     goal of this study is to complete a needs assessment on the problems experienced by those     with rheumatic diseases during computer use. This assessment will lay the groundwork for the     development of outcome measures and interventions to improve computer use for individuals     with rheumatic diseases. In the future it will assist individuals with rheumatic diseases to     be able to use computers more comfortably and efficiently.   "
178292|NCT00177333|"     This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion     doxycycline. The aims of the study are to determine the serum levels of doxycycline when     administered pre-operatively 4 hours or approximately 18 hours before a dilation and     evacuation (D & E) abortion. The hypotheses being tested are that subjects who receive     doxycycline with food the night before an abortion will have adequate serum levels, but less     nausea and vomiting compared to women who take the doxycycline on an empty stomach on the     morning of the abortion. Subjects will either take 200mg doxycycline on the night before and     2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night     before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will     look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels     will be collected from the subjects at the time of surgery.   "
178293|NCT00177346|"     The primary objective of this study is to evaluate carotid artery stenting (CAS) with and     without cerebral protection (CP) to determine if CP improves safety and effectiveness of CAS.   "
178294|NCT00177359|"     The purpose of the study is to examine the effect of an intervention to improve walking based     on motor learning (skill-based) compared to the usual intervention (strength, flexibility and     balance-based) on clinical, psychological and laboratory measures of walking and balance of     older adults with mobility disability (walking problems).   "
178295|NCT00177372|"     This is a pilot clinical trial to evaluate whether the medical management of early pregnancy     failure with mifepristone and misoprostol is an effective and acceptable treatment. Subjects     with early pregnancy failure receive mifepristone followed 24 hours later by vaginal     misoprostol for medical management. Subjects then return on study day 3 for a repeat     ultrasound to assess passage of pregnancy tissue. subjects who still have a gestational sac     present at Day 3 receive a second dose of vaginal misoprostol. All subjects have a follow-up     at Day 15, by phone for those who passed the pregnancy with the first dose of misoprostol,     and in person for those who received a second dose. Questionnaires are administered at the     beginning and end of the study to determine acceptability.   "
178296|NCT00177385|"     The purpose of this study is to see whether protecting sleep quality in later life is     important in continued healthy aging. The value of education in healthy sleep practices along     with reducing time in bed each night by going to bed 30 minutes later, and of healthy dietary     practices will be tested for their effects on sleep quality, health, and well being.   "
178297|NCT00177398|"     The purpose of this study is to determine if the early initiation of a long acting insulin     (i.e. glargine) with supplemental doses of short acting regular (SSR) insulin in hospitalized     patients with diabetes who are fed using tube feedings reduces the frequency of high and low     blood sugar levels when compared to use of SSR insulin alone.   "
178298|NCT00177411|"     This is a single-blinded, one-treatment, combination dose escalation and pharmacokinetic     study done in healthy volunteers. The investigators want to determine whether Parathyroid     Hormone related Protein (1-36) [PTHrP(1-36)] shares anabolic properties with the only     currently approved anabolic agent, parathyroid hormone(1-34) [PTH(1-34)], which stimulates     both osteoblastic bone resorption and formation. In a previous study done by the     investigators, postmenopausal osteoporotic women on estrogen received 6.56 mcg/kg PTHrP(1-36)     subcutaneously for three months daily. They experiences a 4.7% increase in bone mineral     density (BMD) of the lumbar spine when compared with those taking placebo. They also     displayed an increase in serum osteocalcin, a marker of bone formation, with no change in     several markers of bone resorption. It is believed that the rapid absorption and clearance of     PTHrP(1-36) likely plays a central role in its anabolic effect In order to further assess     absorption, we are combining both pharmacokinetic and dose escalation methods for studying     intravenous PTHrP given via a one-time bolus injection. The purpose is to define the maximum     safe dose and measure the pharmacokinetic parameters of a single intravenous dose of     Parathyroid Hormone-related Protein (1-36)[PTHrP(1-36)]. The results will be useful in     determining future treatment options for osteoporosis.   "
178299|NCT00177424|"     This study will determine the effectiveness of sertraline administration after a stroke in     preventing the onset of post-stroke depression.   "
178300|NCT00177437|"     This is a randomized controlled trial to determine whether a home screening test for     chlamydia and gonorrhea will lead to increased use of screening tests and increased detection     of sexually transmitted diseases.   "
178345|NCT00178048|"     The goal of the study is to examine the role of paroxetine, an antidepressant medication, in     the acute and continuation treatment of insomnia. Primary insomnia is a type of insomnia not     directly resulting from general medical, chemical, or psychiatric conditions.   "
178301|NCT00177463|"     Our hypothesis is that oral L-carnosine treatment (as compared with placebo) will enhance     cognitive abilities (specifically: measures of attention, executive function, working memory,     visuospatial ability and language) in persons with bipolar disorder. Secondarily, we     hypothesize there will be secondary improvements in positive, negative and mood symptoms with     L-carnosine treatment.      We aim to test these hypotheses by conducting a randomized, placebo controlled, add on     treatment trial of L-carnosine (added to existing antipsychotic treatment) on 48 recruited     subjects with DSM IV TR bipolar disorder for a period of 12 weeks. Measures of cognition, and     psychopathology will be utilized for evaluating primary and secondary outcomes, along with     safety assessments.   "
178302|NCT00177476|"     The purpose of this study is to examine whether behavioral strategies implemented during the     adoption versus the maintenance periods of weight loss to enhance exercise participation in     overweight adults are more effective than a standard behavioral intervention.   "
178303|NCT00177489|"     The primary goal of this study is to test a single multi-component intervention among family     caregivers of persons with Alzheimer's disease or related disorders. The overall objectives     of study are to 1) identify and reduce modifiable risk factors among diverse family     caregivers of patients with Alzheimer's Disease or a related disorder, 2) enhance the quality     of care of the care recipients, and 3) enhance the well-being of the caregivers.   "
178304|NCT00177502|"     The purpose of this study is to examine the dose-response of exercise on prevention of weight     gain in overweight adults.   "
178305|NCT00177515|"     The purpose of this study is to determine whether video doctor programs can effectively     deliver preventive health messages to women of reproductive age while they wait to be seen in     urgent care settings. In this study, the specific hypotheses being tested are: 1) is the     video doctor program effective in improving women's knowledge about emergency contraception,     and 2) is the video doctor program effective in improving women's knowledge about the     importance of folate.   "
178306|NCT00177528|"     This research study is to evaluate the safety and usefulness of venlafaxine-XR in the     treatment of major depression in the elderly.   "
178307|NCT00177541|"     To determine the mechanisms mediating the therapeutic efficacy of pelvic floor muscle     exercises and biofeedback for urge urinary incontinence, as well as the characteristics of     patients most likely to respond. By identifying the key components of this treatment, we hope     to simplify it and make it more easily applicable, more effective, less expensive, and thus     more useful for people with urge incontinence in the future.   "
178308|NCT00177554|"     The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy     in followed by Zevalin in previous untreated patients with follicular lymphoma   "
178309|NCT00177567|"     The purpose of this study is to collect pilot data on the feasibility of recruiting,     eliciting informed consent, assessing, treating, and following patients aged 60 and older     with bipolar mood disorders.   "
178310|NCT00177580|"     This study supplements patients' current medications with Pravastatin, a cholesterol-lowering     medication, to try to improve residual symptoms of schizophrenia, and also to improve     cognitive functioning.   "
178311|NCT00177593|"     The purpose of this study is to examine the effect of a computer tracking system and energy     expenditure device on weight loss in adults.   "
178312|NCT00177606|"     The purpose of this study is to validate a set of proposed clinical criteria that have been     designed to identify patients who will die rapidly following the elective removal of life     sustaining treatments.   "
178313|NCT00177619|"     The overall goal of this proposal is to determine the effectiveness and safety of once weekly     alendronate (Fosamax) in the prevention and treatment of osteoporosis in men with prostate     cancer on androgen deprivation therapy and to evaluate maintenance of bone mass following     termination of therapy after one year.   "
178314|NCT00177632|"     The purpose is to examine the additional effect of either yoga or resistance exercise on     weight loss weight combined with a standard behavioral weight loss intervention.   "
178315|NCT00177645|"     The purpose of this study is to see if inhaled bicarbonate will increase the ability to cough     up mucus in a person with cystic fibrosis.   "
178316|NCT00177658|"     To determine the clinical significance of gene mutations encoding antibiotic resistance, but     not expressed as clinical resistance, in Salmonella bacteria   "
178317|NCT00177671|"     This study will determine the effectiveness of combining escitalopram, venlafaxine, or     duloxetine with donepezil, a medication used in Alzheimer's disease, in improving memory,     concentration, attention, and problem solving abilities, and reducing the risk of depressive     relapse in older individuals with depression.   "
178318|NCT00177684|"     The purpose of this study is to determine the optimal delivery system for the nebulization of     the lipid complex amphotericin B (Abelcet ®) in lung transplant recipients who are positive     for invasive aspergillosis (IA) in their lungs. Additionally, the investigators hope to     determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and     serum with the administration of four days of lipid complex of amphotericin B (Abelcet ®)     (QD) via aerosolized nebulization   "
178319|NCT00177697|"     The purpose of this study to examine the effect of having a weight loss mentor on long-term     weight loss in overweight adults.   "
178320|NCT00177710|"     The purpose of this study is to determine the steady state concentrations of inhaled     liposomal amphotericin B (Ambisome®) in lung transplant recipients via aerosolized     nebulization.   "
178321|NCT00177723|"     The study will evaluate and improve the performance of pharmaco-statistical models previously     developed in the compassionate use program in patients being treated with linezolid under     clinical usage conditions. This study will also develop a sensitive and specific tool that     may be used to predict patients at risk of hematological toxicity, based on factors including     linezolid concentration and duration of therapy and use these models to better understand the     determinants of toxicity with linezolid and define better strategies to manage toxicity or     reduce its occurrence.   "
178346|NCT00178061|"     This study will examine the impact of comorbid personality disorder on the outcome of     treatment among patients with bipolar I disorder.   "
178347|NCT00178074|"     This study will use positron emission tomography (PET) to examine the effect of sleep     deprivation on brain function.   "
178322|NCT00177736|"     Pharmacokinetics is the study of the disposition of drugs in the body, while pharmacodynamics     considers the interaction of the drug at the site of infection over time. Mathematical models     of antibiotic pharmacodynamics are sometimes used to predict if antibiotic doses are     sufficient to treat infection with organisms of different minimal inhibitory concentrations     of the antibiotic. Based on these models, there has been speculation that the antibiotic     cefepime dosed at one gram every 12 hours, is insufficient to kill all organisms within the     susceptible range. This study of patients treated with cefepime will involve the collection     of blood to determine cefepime concentrations, and determine if those concentrations are     effective in killing the bacteria at the site of infection.   "
178323|NCT00177749|"     Therapeutic options for serious fungal infections are limited by intrinsic and acquired     resistance to existing antifungal agents. For example, zygomycetes (such as Mucor spp.) are     intrinsically resistant to voriconazole and caspofungin. Yet, the only available therapeutic     option, amphotericin, is associated with significant renal toxicity, even in lipid     formulations. Posaconazole is a new antifungal drug, not yet Food and Drug Administration     (FDA) approved, but which has excellent in vitro activity against some intrinsically     resistant fungi such as the zygomycetes.      The intent of this trial is to provide access to posaconazole to patients with serious fungal     infections which are refractory to standard antifungal therapies or invasive fungal     infections for which there are currently no effective therapies. Secondly, the drug will also     be made available to patients with invasive fungal infections who:        -  have experienced serious or severe toxicities while receiving standard antifungal          therapies;        -  have pre-existing renal dysfunction which precludes use of standard antifungal          therapies; or        -  are chronically immunosuppressed with a history of invasive fungal infections previously          treated with posaconazole in other clinical trials, and who require oral antifungal          suppressive therapy as maintenance treatment to prevent recurrence.      This is a multicenter, open-label, non-comparative experimental treatment use protocol. The     experimental treatment use protocol will provide the investigational medication posaconazole     where no other drug is commercially available. Posaconazole is given as an orally or     enterally administered suspension. The duration of therapy is at the discretion of the     investigator. Safety assessments will include an electrocardiogram [ECG] (to ensure no QTc     interval prolongation) performed at baseline and serum/urine pregnancy testing performed at     baseline and every three months after initiation of therapy. Plasma concentrations will be     obtained if there is evidence of clinical failure. No other tests will be performed     specifically for the experimental treatment use protocol.   "
178324|NCT00177762|"     The purpose is to examine varying durations and intensities of exercise on long-term weight     loss.   "
178325|NCT00177775|"     The primary objective of this study is to assess the safety of the investigational agent,     MucoMilk®, a polyclonal-antibody enriched Whey Protein Concentrate 40% (WPC-40) made of milk     of immunized cows. Secondary objectives will investigate the effectiveness of MucoMilk® as an     aid in the prevention of relapse of C. difficile-associated diarrhea (CDAD).   "
178326|NCT00177788|"     The study aims to determine if voriconazole prevents invasive fungal infections in liver     transplant recipients. Endpoints would be: occurrence of invasive fungal infection and fungal     colonization. Two groups will be compared: patients who received voriconazole as prophylaxis     and historical controls who did not receive this prophylaxis.   "
178327|NCT00177801|"     Fungal infections are leading causes of morbidity and mortality in transplant recipients, yet     comprehensive epidemiologic studies in this area are lacking. For this reason, the Centers     for Disease Control and Prevention have provided a grant to the University of Pittsburgh to     study this subject.      The study has four specific aims:      1. To determine the risk of fungal infections in a center where tolerogenic     immunosuppressive protocols are currently in place, and to determine whether there are any     measures of immune system function which correlate with risk of fungal infection.      2: To create a repository of serum, urine and bronchoalveolar lavage specimens for the     purpose of determining the effectiveness of novel diagnostic tests for invasive fungal     infections. Such a repository could also be utilized for the purpose of determining the     effectiveness of novel diagnostic tests for viral infections such as West Nile Virus,     cytomegalovirus, HHV-6 and HHV-8.      Specific aim 1 will be investigated by creating a prospective database of solid organ     transplant recipients at the University of Pittsburgh Medical Center, including demographic     factors as well as subsequent development of infection. The immune function of patients will     be assessed by measuring T cell subsets and assessing T cell function using the Cylex assay.     Specific aim 2 involves collection of serum, urine and bronchoalveolar lavage fluid. These     specimens will be stored and later tested at the Centers for Disease Control and Prevention     in the assessment of novel tests developed for the diagnosis of invasive fungal infections.   "
178328|NCT00177814|"     The proposed endpoints of the study would be: comparative use of piperacillin versus broader     spectrum agents (e.g., piperacillin/tazobactam, etc.) [measured as defined daily doses per     1000 patient days]; physician acceptance of piperacillin as part of a streamlining program     [measured as successful occurrences of the use of piperacillin as streamlining therapy];     changes in susceptibility patterns of broad spectrum antibiotics [measured as % Gram negative     bacilli susceptible to each of the commonly used broad spectrum antibiotics]; and outcome of     patients treated with streamlined therapy.   "
178329|NCT00177827|"     A fixed dosage regimen of voriconazole is routinely used for prophylaxis of aspergillosis in     lung transplant patients at our institution. We hypothesize that use of a fixed dosage     voriconazole regimen leads to large degree of variability in drug exposure among lung     transplant patients and consequently, therapeutic failures or toxicity. This is a three part     study which will examine plasma and lung voriconazole concentrations achieved with the     prophylactic regimen and assess for a correlation between these concentrations with efficacy     and toxicity. We aim to conduct an initial pilot study in 12 lung transplant patients to     characterize the pharmacokinetic profile of voriconazole with both intravenous and oral     doses. The data gathered from the pilot pharmacokinetic study will then be utilized to     correlate trough concentrations with total voriconazole drug exposure as measured by area     under the plasma concentration versus time curve (AUC). Additionally, trough concentrations     will be followed over nine weeks of the prophylactic treatment period in a larger cohort of     patients to determine maintenance of consistency in trough concentrations and whether the     plasma concentrations are predictive of efficacy and toxicity. Voriconazole lung     concentrations will be measured in a pilot study of 12 patients who undergo a bronchoscopy     procedure as part of their standard medical care in order to determine the relationship     between plasma and lung concentrations. The information obtained from this three phase study     will be utilized to characterize the pharmacokinetics of voriconazole in lung transplant     patients. Further, it will be used to define an optimal therapeutic voriconazole regimen that     will be individualized to target specific concentrations in the lung and plasma to maximize     efficacy and minimize toxicity   "
178330|NCT00177840|"     This study will evaluate if acupuncture is helpful in treating cancer-related fatigue in     breast cancer patients undergoing radiation therapy.   "
178331|NCT00177853|"     The purposes of this study are to examine the effects of a new combination of drugs,     celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people     before they undergo surgery; to determine what effects this combination has on pancreatic     cancer; and to determine the highest dose of celecoxib and irinotecan that can be given     safely without causing severe side effects. While not an endpoint, it is hoped that this     combination will also shrink tumors enough for excision.   "
178332|NCT00177866|"     The investigators will select 60 people who are 18-70 years of age with Crohn's disease and     randomly assign them to receive an 8-week trial of celecoxib and an 8-week trial of a     placebo. There will be a 1-week interval or wash-out between trials when the participant     does not take any study medication. The investigators will monitor the participants for 18     weeks after they start the medication and observe their Crohn's disease activity, assessing     for flare-ups or exacerbations in the disease and other possible side effects of celecoxib.     Based on these observations, a determination will be made by the investigators as to the     safety of celecoxib. If celecoxib is found to be safe, then it may provide physicians with a     medication that they can prescribe for people who have Crohn's disease and experience chronic     pain from arthritis and arthralgia.   "
178333|NCT00177879|"     This study will determine the usability of a website for people with schizophrenia versus     other websites designed for the same purpose.   "
178334|NCT00177892|"     The purpose of this study is to define the mechanism(s) through which Obstructive Sleep     Apnea/Hypopnea (OSAH) promotes abnormal metabolic processes which characterize the metabolic     syndrome. The investigators hypothesize that the sleep fragmentation and intermittent sleep     hypoxia which occur in OSAH patients promote oxidative stress and inflammation which in turn     lead to insulin resistance, dyslipidemia, abnormal vascular reactivity and other processes     which are consistent with the metabolic syndrome.   "
178335|NCT00177918|"     The primary aim of this study is to determine prospectively the viral and C. pneumoniae     infection prevalence and outcomes of infections in lung transplant recipients. The study will     also determine the correlation of C. pneumoniae infection with the development of obliterans     in lung transplant recipients.   "
178336|NCT00177931|"     The purposes of this study are to:      I. Characterize the plasma concentration-time profile of cefepime in liver transplant     patients to determine the pharmacokinetic parameters in this patient population.      II. Perform stochastic modeling using the population pharmacokinetic parameters obtained in     Specific Aim I to determine the ideal dose and dosing regimen of cefepime required to attain     predetermined therapeutic targets in liver transplant patients.   "
178337|NCT00177944|"     The purpose of this study is to optimize the management of patients treated for invasive     fungal infections by establishing a real-time, continuous clinical data base that will     capture and monitor trends in the epidemiology, diagnosis, treatment and outcomes of invasive     fungal infections; reflect routine clinical management of patients with invasive fungal     infections in order to evaluate treatment and provide a rationale for future treatment     paradigms; and allow physicians to assess adherence to institutional clinical practice     guidelines, validate current standardized definitions for patients with invasive fungal     infections and promote change where appropriate.   "
178338|NCT00177957|"     The aims of this study are to:        -  Determine the risk factors for multidrug resistance in bloodstream isolates of Gram          negative bacilli        -  Determine the mechanisms of multidrug resistance in bloodstream isolates of Gram          negative bacilli        -  Determine the risk factors for failure of prompt clearance of the blood of Gram negative          bacteria        -  Determine the survival of patients with Gram negative bacteremia        -  Determine if failure of prompt clearance of the blood of Gram negative bacteria is a          predictor of mortality following this infection   "
178339|NCT00177970|"     In this trial, eligible patients will be randomly assigned to receive a single dose of 400     mg/kg of IVIG or a normal saline infusion as placebo over 4-6 hours, in addition to their     usual medications for CDAD. We expect to enroll approximately 40 patients over a period of     two years from UPMC Shadyside Hospital, McKeesport Hospital, and St. Margaret's Hospital who     are unresponsive to standard antimicrobial therapy for CDAD.      During the course of this study we expect that IVIG group compared with placebo group will     have fewer number of stools per day (< 3 per day). Secondary endpoints will include normal     WBC count, normal body temperature, 75% reduction in abdominal pain / tenderness, and     decrease in length of hospital stay.      Subjects will sign a written informed consent prior to any study procedures. Patients will be     monitored closely during the infusion of the study medication and will continue to be     monitored on a daily basis up to the time of discharge. Data collection will include vital     signs, CBC, stool C. difficile cytotoxin assay, and stool counts before and after therapy.   "
178340|NCT00177983|"     This study will assess the feasibility of using the internet and in-home computers to provide     advice from health care professionals, social support, and health information to people with     schizophrenia and their families.   "
178341|NCT00177996|"     This research study is being conducted to find out if certain individuals benefit from taking     medication for their depression with a low dose of the antidepressant medication Zoloft.   "
178342|NCT00178009|"     Discharge to the community is increasingly becoming a priority for patients implanted with a     Ventricular Assist Device (VAD). Because VADs are complex, patients and caregivers often fear     leaving the hospital, although their status does not require hospitalization. This project     includes development of CD/video and web-based instructional programs on management of the     VAD controller for patients and their caregivers (formal and informal). A clinical trial will     be used to examine discharge rates and placements following patients educated under usual     care vs. self-pace CD/video conditions.   "
178343|NCT00178022|"     The primary aims of this project are to examine the feasibility and relative efficacy of two     models of on-line intervention for families of children with traumatic brain injury: one, a     model emphasizing cognitive appraisals and problem solving skills; the other, emphasizing     linking families to resources and providing professionally-moderated peer support.   "
178344|NCT00178035|"     This study will determine the effectiveness of total sleep deprivation (TSD) for one night     plus paroxetine versus either TSD plus placebo or paroxetine alone in inducing rapid symptom     resolution of major depression in the elderly.   "
178450|NCT00179452|"     To establish the safety and feasibility of having patients with epilepsy perform yoga.   "
178351|NCT00178126|"     The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial     (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing     sitting-acquired pressure ulcers in the elderly, nursing home population. Positive results of     the proposed trial will provide the level of evidence needed to change the standard of care     to include the routine evaluation of at-risk residents for seating and positioning needs and     the provision of pressure-reducing cushions as a preventive measure against sitting-acquired     pressure ulcers. If our hypothesis is valid, such intervention should result in a decrease in     the incidence and prevalence of sitting-acquired pressure ulcers, reduced healthcare costs,     and improved quality of life.   "
178352|NCT00178139|"     The purpose of the study is to determine whether Music Therapy interventions can be used as     supportive therapy for patients undergoing weaning from mechanical ventilation. The music     will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety     management.Music used is varied according to subject's preferences.   "
178353|NCT00178152|"     Erythema Toxicum Neonatorum (ETN) is a common skin finding that affects healthy full-term     babies. Several authors have commented on the possible relationship between ETN and the     development of atopic conditions, such as atopic dermatitis or respiratory disease later in     life. There is a paucity of research addressing this issue.   "
178354|NCT00178165|"     Established in 1995, Resources for Enhancing Alzheimer's Caregiver Health (REACH) is a     unique, multi-site research program sponsored by the National Institute on Aging (NIA) and     the National Institute on Nursing Research (NINR). The primary purpose of REACH is to carry     out social and behavioral research on interventions designed to enhance family caregiving for     Alzheimer's disease and related disorders. Specifically, REACH has two goals: to test the     effectiveness of multiple different interventions and to evaluate the pooled effect of REACH     interventions overall. REACH grew out of a National Institute of Health (NIH) initiative that     acknowledged the well-documented burdens associated with family caregiving as well as the     existence of promising family caregiver interventions reported in the literature.   "
178355|NCT00178178|"     This investigation will evaluate the subjective effect on postoperative pain of three     catheter placements in the knee:        1. intraarticular infusion only,        2. patellar tendon harvest site only,        3. both intraarticular and patellar tendon harvest site.   "
178356|NCT00178191|"     The purpose of this study is to determine how effective Botox is in reducing the amount of     urine leaked and which dose of Botox is more effective and safe in those who have urinary     urge incontinence.   "
178357|NCT00178204|"     The purpose of this study is to identify specific chemotherapy-related changes in sleep     stages/architecture that may relate to an increase in fatigue in individuals with cancer.      The researchers hypothesize that the fatigue experienced by cancer patients receiving     chemotherapy is in part due to changes in restorative sleeping during the non-rapid eye     movement cycles of sleep (i.e., delta activity).   "
178358|NCT00178217|"     The primary objectives for this study are:        1. To demonstrate that music therapy can be an effective means of procedural support for          children undergoing botox injections.        2. To explore patient, parent and healthcare personnel satisfaction with music therapy as          procedural support.        3. To assess the influence of music therapy on physiologic (blood pressure, oxygen          saturation, heart rate) and emotional (crying time) responses of patients.   "
178359|NCT00178230|"     This study is being conducted by the University of Rochester Cancer Center to determine the     levels of cytokines in the blood, and to determine if blood levels of these cytokines are     related to the side effects of radiation therapy combined with other treatments.   "
178360|NCT00178243|"     A study is being conducted by the University of Rochester Cancer Center (URCC) in which     patients with liver cancer will be treated with high dose conformal radiation therapy. This     type of radiation uses new techniques which aim the radiation to the sites of disease     allowing the tumor to receive a high dose and the surrounding normal liver tissue to receive     a low enough dose that the normal tissue should remain free from injury.      The purpose of the study is to determine if the conformal radiation therapy is safe,     tolerable and effective in treating liver cancer and to determine the side effects caused by     this treatment. A second objective is to determine if the levels of a special type of protein     (called cytokines) found in the blood are related to this treatment.   "
178361|NCT00178256|"     A treatment study is being conducted by the University of Rochester Cancer Center (URCC) in     which patients with non-small cell lung cancer will be treated with radiation therapy and a     drug called paclitaxel. Paclitaxel is a natural product with anticancer properties. The first     purpose of this study is to determine the dose of paclitaxel which, when given in combination     with radiation therapy, will provide the greatest effect have the least side effects. To     determine this, patients will be put on the study in groups of 3. The dose for each     additional group will be higher than the previous dose until the maximum tolerated dose is     reached. The second purpose is to determine if radiation therapy with paclitaxel is more     effective in treating lung cancer than radiation therapy alone.   "
178362|NCT00178269|"     The purpose of this study is to find out how effectively cervix cancer is controlled when     radiation is combined with low-dose chemotherapy (Taxotere) . The use of low-dose Taxotere,     once per week, with radiation is a new treatment for cervical cancer. This study will also     see how well this treatment regimen can be tolerated.   "
178363|NCT00178282|"     The purpose of this study is to determine if pelvic exercises can reduce the occurrence of     urinary incontinence (involuntary loss of urine) before and after delivery. We would also     like to see if performing pelvic exercises before birth has an effect on labor and/or     delivery, and if there are any specific characteristics for developing urinary incontinence     during pregnancy and after delivery.   "
178364|NCT00178295|"     Treatment for brain cancer may include radiation therapy. Radiation therapy is the treatment     of tumors with X-rays. This study is related to understanding the side effects of radiation     treatment for brain tumors.      This study is being conducted by the University of Rochester Cancer Center to compare the     extent of side effects of brain cancer treatment with changes in levels of blood proteins     called cytokines.   "
178446|NCT00179400|"     Doctors are studying natural oils as potential therapies for type 2 diabetes. Animal studies     have suggested promising results using EPA (found in fish oils) to improve insulin action and     lower blood sugar levels.   "
178365|NCT00178308|"     The purpose of this research is to evaluate an automated, laser-based technique for measuring     DNA damge resulting from radiation. We want to use controlled exposure on cancer patients to     help develop a measurement to test people who may have been accidentally exposed to     radiation.   "
178366|NCT00178321|"     Sleep is disrupted in the PICU. This disruption has been reported in studies that have used:     (a) observation of sleep-wake cycles (b) self-reports by children themselves , and (c)     objective measures (e.g., electroencephalograph( EEG). Noise and light levels have been     correlated with profound sleep disruption in the PICU . Sleep disruption is known to have a     profound impact on the overall health of a child, both from a physiological and a     psychological standpoint . In addition, sleep disruption has been shown to change cortisol     levels, cause impaired immune responses and impair cognitive function in both children and     adults . Disruption in sleep also is known to impair healing through these many complex     connections with other homeostatic processes in the human body. What is the effect of wearing     earplugs in critically ill children admitted to the PICU on:        1. Sleep states        2. Physiological stability (e.g. melatonin, cortisol and immune status)        3. Sleep habits after discharge from the PICU (on the general pediatric unit, 2 weeks and 2          months after discharge), and        4. Child behavior at 2 weeks and 2 months after discharge from the PICU by parent report on          the Child Behavior Checklist (CBCL).   "
178367|NCT00178334|"     The purpose of this study is to:        -  Assess the rate of screening for urinary incontinence (UI) in women by their primary          care providers        -  Identify the type of screening used by primary care providers        -  Identify barriers to screening for UI        -  Identify differences in screening rates between specialties        -  Assess whether primary care providers view UI as a serious medical problem        -  Assess the comfort level of primary care providers in the diagnosis and treatment of UI        -  Identify primary care providers' preferred mode of learning more about UI   "
178368|NCT00178347|"     Irradiation of any tissue creates changes in that tissue. Ionizing radiation imparts charges     to the tissue as it interacts with tissue components, changing the tissue structure. The     specific type of modification also depends to some extent upon the type of tissue irradiated.     It has been shown that it is possible to read the tooth enamel irradiation record using     techniques such as electron paramagnetic resonance (EPR), or electron spin resonance (ESR).      It is proposed to examine radiation responses in approximately one hundred (100) human teeth.     This would include teeth free of, as well as those containing, amalgam (silver) restorations.     For the first group, teeth that have already been collected (pre-existing pathological     specimens) would be used. These teeth were surgical/pathological discards collected without     identifiers by the dental providers.   "
178369|NCT00178360|"     The purpose of this study is primarily to assess the ability of a music therapy program to     improve holistically the psychological, somatic, and social symptoms of patients with     Huntington 's disease (HD). We hope to demonstrate the benefits of applying music therapy     interventions to the management methods of HD, thus paving the way for the development of an     effective music therapy program for individuals with HD.   "
178370|NCT00178373|"     The purpose of this study is to determine the efficacy of modafinil with regard to reducing     cancer-related fatigue in cancer patients following chemotherapy or radiation therapy.     Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be     assessed.      The researchers hypothesize that administering modafinil (PROVIGIL®) to patients experiencing     fatigue following completion of cancer treatment will lead to reduction in patient fatigue     and prevention of or improvement in patient cognitive dysfunction.   "
178371|NCT00178386|"     The purpose of the study is to evaluate some educational outcomes of children treated for     childhood cancer.   "
178372|NCT00178399|"     The standard therapy in cases such as yours is surgery, radiation therapy, chemotherapy or     hormonal therapy alone or in combination. The main purpose of this study is to evaluate     whether radiosurgery alone affects your quality and length of life. A second purpose of this     study is to determine if the levels of special types of protein (called cytokines) found in     the blood are related to your quality of life during your course of treatment and follow-up.   "
178373|NCT00178412|"     In this study, an intervention is tested that is designed to improve the outcomes of     hospitalized elders and family caregivers.      Study design:        -  randomized, controlled study        -  participants: 280 family caregivers aged 21 or above        -  length of follow-up: 2 weeks and 2 months after hospitalization      Study hypothesis: In this randomized clinical trial, the following hypotheses will be tested:        1. Hospitalized elders whose family CGs receive the CARE program versus those who receive a          comparison program will have better outcomes during and after hospitalization as          measured by: (1) fewer incidents of dysfunctional syndrome; (2) shorter hospital stays;          (3) lower readmission rates; (4) less depressive symptoms; (5) higher cognitive level;          (6) less functional decline perceived by family CG; and (7) a closer relationship with          their family CGs.        2. Family CGs of hospitalized elders who receive the CARE program will report: (1) More          positive beliefs about their loved one's responses to hospitalization and their role in          the hospital setting; (2) more positive emotional outcomes (less worry, anxiety, and          depressive symptoms) during and after hospitalization; (3) More participation in their          loved one's care during hospitalization; and (4) More positive role outcomes (more role          reward, less role strain, more prepared for their loved one's care, and a closer          relationship with their elderly relatives, both during and after hospitalization).        3. The proposed model to explain the effects of the CARE program on the process and          outcomes of family CG coping and elderly patient outcomes will be supported for CGs and          elderly patients.   "
178374|NCT00178425|"     The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the     blood at a given time. Currently MMF is ordered as a set dose and tacrolimus is given based     on body weight. While the deceased donor transplant receives the complete liver, in the live     donor just over half of the liver is given (about 60%). The way these different types of     transplants break down drugs could be different. Measuring the drug levels allows us to know     what happens to the medication in between the morning and the evening dose.   "
178375|NCT00178438|"     The purpose of this study is to determine the best role for capsule endoscopy in diagnosing     Crohn's disease.   "
178376|NCT00178451|"     In the first portion of the study, the goal will be to determine the safety of the drug     Abciximab for use during and in the period after open carotid artery surgery. In addition,     using specialized ultrasound equipment (a probe that is placed on the outside of your skin of     your head), we will aim to measure the number of particles released around the time of     surgery while being treated with Abciximab. The second phase of the study will be determine     if Abciximab can safely reduce the number of particles released into the bloodstream around     the time of surgery in order to reduce the risk of stroke.   "
178377|NCT00178464|"     Neurologic complications secondary to cerebrovascular damage are prevalent in children with     sickle cell disease. These patients experience both clinically overt cerebrovascular     accidents and silent infarctions demonstrated by magnetic resonance imaging (MRI). They are     also at risk for neurocognitive abnormalities.We hypothesize that daily, low-dose aspirin     therapy will safely diminish the incidence and progression of cognitive deficits as well as     the predisposition to overt and silent stroke in children with homozygous sickle cell disease     (Hgb SS) or hemoglobin S Beta Zero Thalassemia (Hgb SB-0 Thal). In order to optimize the     design of a future trial to test this hypothesis, we propose a pilot study to test the safety     and tolerability of aspirin in young children with sickle cell disease.   "
178378|NCT00178477|"     The purpose of this research study is to evaluate typical tumor motion caused by breathing     using MRI and can help determine whether simple passive breathing and/or breath-holding could     be used for the future treatment of similar lung and liver tumors using radiation therapy     radiosurgery techniques.   "
178379|NCT00178490|"     High blood pressure, or hypertension, affects up to 10% of minority children and adolescents.     Although complications of high blood pressure, such as stroke and heart attack, are uncommon     in childhood, high blood pressure-related organ damage can occur at a young age. Studies with     young adults have indicated that high blood pressure can affect the central nervous system,     resulting in deficits in brain function. However, more research is necessary to confirm the     association between neurocognitive deficits and high blood pressure in children and to     determine if these deficits are reversible with treatment. This study will determine whether     high blood pressure in children and adolescents has subtle effects on learning, attention,     and concentration. The study will also determine the effect of an antihypertensive treatment     plan, involving a combination of diet, weight loss, increased exercise, and if needed, blood     pressure medication, on brain function in children and adolescents receiving treatment for     high blood pressure.   "
178380|NCT00178503|"     This study examined the cognitive and behavioral differences in children who have an autism     spectrum disorder (ASD) with or without additional symptoms of ADHD. The study also examined     the effectiveness of a range of doses of methylphenidate in improving cognitive and     behavioral outcomes in children with both ASD and ADHD.   "
178381|NCT00178516|"     The goal of this study is to determine whether there is a correlation between the levels of     Vitamin E in sperm and sperm DNA fragmentation.      Previous research has shown that damage to the DNA in sperm may cause infertility or increase     the chances of miscarriage, if the damage is extensive (eg. present in the overwhelming     majority of sperm). Some studies suggest that DNA damage can be caused by oxidative stress.     Antioxidants, such as Vitamin E, which are present in some foods, can prevent damage to cells     from free radicals, which are naturally present by-products of metabolism. We ask whether     there is a correlation between sperm DNA damage and Vitamin E   "
178382|NCT00178529|"     This is an interdisciplinary, intervention study with stroke survivors and their spousal     caregivers after discharge from a rehabilitation unit. It will determine whether couples     receiving home visits from nurses and therapists over a 6 month period demonstrate better     function and less psychological distress than couples who receive information by mail. All     couples are visited every 3 months by a nurse who assesses their physical and psychosocial     functioning.   "
178383|NCT00178542|"     The primary objective of this study is to describe characteristics and trends for thrombin     generation (TG) and thromboelastography (TEG) at 4 time points during the menstrual cycle.   "
178384|NCT00178555|"     The purpose of this study is to determine if the Video Laryngoscope (VL) is a useful     instrument in patients at risk for difficult intubation. We will compare this device to the     traditional Macintosh Laryngoscope.   "
178385|NCT00178568|"     People under stress, such as those caring for an ill family member, often have trouble with     their sleep. The aim of this study is to see if reducing stress and changing a caregiver's     sleep and wake patterns will improve his/her sleep. The investigators also will see whether     improvements in sleep result in improved mood, health, and general functioning.   "
178386|NCT00178581|"     Glutamine is considered a conditionally essential amino acid during critical illness. After     severe trauma, glutamine supplementation into the gastrointestinal tract may help maintain     bowel function. We hypothesize that for the major torso trauma patient, high dose glutamine     given enterally during resuscitation from shock and continued during enteral nutrition     support is absorbed, available systemically and preserves gut integrity.   "
178387|NCT00178594|"     The objective of this study will be to assess the coagulation system in-vitro in a variety of     bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay.   "
178388|NCT00178607|"     To correlate the Human Leukocyte Antigen type and genetic defect with hemophilia A.   "
178389|NCT00178620|"     The PATCAR study has been designed to test the hypothesis that the strategy of pre-hospital     use of a clot busting (thrombolytic) drug followed with emergent heart catheterization     including stenting of the problematic coronary artery, will result in a lower mortality and     reduced repeat heart attack rates.      Early identifying and treating heart attacks patients prior to the arriving at the hospital,     in those patients who qualify for the clot busting drugs will lower the size of the heart     attack damage. This smaller heart attack will lead to fewer problems with less repeat heart     attacks and death in the future.   "
178390|NCT00178633|"     An original cohort of 43 patients were recruited for analysis of anthropometrics, metabolic     profile, skeletal muscle biopsy, echocardiogram at baseline, 3 months and 9 months post     bariatric surgery. While all 43 patients reportedly completed 3 and 9 month evaluations, only     15 patients completed 24 month evaluations due to 28 patients unwilling to return.      The overarching purpose appears to have been not only evaluation of weightloss, but     normalization of metabolic profile over time.   "
178393|NCT00178672|"     The primary objective of this study is to assess the safety and effectiveness of stenting in     the treatment of obstructive carotid artery disease. Secondary objectives are the assessment     and standardization of optimal operator techniques and successful deployment and retrieval of     the AngioGuard XP Distal Protection Device. This is a single center, prospective, open-label     feasibility study. The study population will consist of patients with atherosclerotic     obstructive or post-endarterectomy restenotic lesions in native carotid arteries. The     intention is to include patients with both types of lesions.   "
178394|NCT00178685|"     These two studies will examine the role of autonomous motivation in maintained adherence. The     first study will determine whether smokers are still abstinent from tobacco 32 months after     starting in a previous project (Smoker's Health Study). The purpose of the second study is to     determine which of three treatments for tobacco dependence provides the greatest amount of     protection from relapsing to smoking after quitting. Specifically, the investigators will     determine if extending the length of treatment time focusing on relapse prevention and     arranging for support from important others prevents relapse compared to community care.     Also, the investigators will determine if providing extended treatment time and support from     important others plus providing medications to those that don't want to quit prevents long     term relapse compared to just extending the length of treatment time and support from others.     Additionally, a sub set of the population will be randomized to using hand held palm devices     to recover real-time data assessment during the last 10 months of the project.   "
178395|NCT00178698|"     Thermal therapy (hyperthermia, or heat) increases chemotherapy cancer cell kill. By itself,     thermal therapy can also kill cancer cells. Whole body thermal therapy is a systemic     treatment; whole-body fever-range thermal therapy can safely treat cancer cells wherever they     are throughout the entire body. In this study, we are testing the combination of fever-range     heat treatment and chemotherapy to test 1) The response of three types of cancer (small-cell     lung, neuroendocrine cancer, lung cancer, and gastric cancer) to the thermo-chemotherapy     improves cancer response compared to the effect of only chemotherapy drugs in current use; 2)     whether the thermo-chemotherapy treatment helps the person's own body fight the cancer cells;     and 3) whether this treatment is safe and comfortable for the patient. This study does not     offer heat treatment alone. Any patient with inoperable or metastatic small cell lung cancer,     neuroendocrine cancer (any organ), gastric cancer, or lung cancer, can be treated with the     Phase II protocol therapy; however, the patient will need to undergo selected medical tests     to make sure this treatment would be safe for them.   "
178396|NCT00178711|"     Induction of hypothermia to < 35˚C by < 2.5 hours after severe traumatic brain injury,     reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will     result in an increased number of patients with good outcomes at six months after injury     compared to patients randomized to normothermia.   "
178397|NCT00178724|"     The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting     de-identified data from patients admitted through the Emergency Department of a NACTN center     at the time of injury with an initial (first time) spinal cord injury (SCI). Information will     be collected on the natural history of SCI and course of treatment through the first 12     months from the date of injury or long as medically indicated. Data collected includes     imaging information from CT or MRI scans, neurological and general medical outcome and     rehabilitation evaluation. No intervention is given other than standard of care for spinal     cord injury.   "
178398|NCT00178737|"     In this research we propose to develop a comprehensive model to explain how users process     persuasive messages. We then propose to experimentally test varying the persuasiveness of     message content in various domains, and assess their impact on adherence by both physicians     and patients. Finally based on our conceptual model and results from the experimental data we     propose to develop preliminary guidelines to assist developers in designing effective     messages.   "
178399|NCT00178750|"     The purpose of this study is to compare how well the CompuFlo® computerized syringe pump     works as compared to the traditional method of inserting an epidural (a needle placed in     one's back to give pain medicine).   "
178400|NCT00178763|"     Thermal therapy (hyperthermia, or heat) enhances the chemotherapy anti-tumor kill. Thermal     therapy by itself also kills cancer cells. Whole-body thermotherapy is a systemic treatment     that includes the entire body. By using fever-range whole-body thermal therapy, cancer cells     can be treated wherever they are throughout the entire body. In this study, we are testing a     combination of fever-range thermal therapy combined with chemotherapy to test: 1) the     response of metastatic or advanced pancreas cancer to the combined modality treatment of     thermotherapy and selected chemotherapy; 2) whether it helps the body immunity fight the     pancreas cancer; and 3) if this treatment is safe for the patient.      This study does not offer thermal therapy alone. Any patient with measurable, inoperable or     metastatic pancreatic cancer may be treated; however, the they will need to undergo specific     medical tests to make sure this treatment would be safe for them.      We hypothesize that a combined-modality therapy using fever-range whole-body hyperthermia     (FR-WBH; temperature = 40 o C; duration = 6 h), administered in an optimized time/sequence     schedule with cisplatin, gemcitabine HCl (gemcitabine), and metronomically administered,     low-dose interferon-alpha (IFN-alpha) to patients with inoperable or metastatic pancreas     cancer, will, without inducing intolerable toxicity: a.) decrease the pancreatic cancer size;     b.) improve quality of life; c.) enhance the immune response against the cancer; d.) increase     survival; and e.) allow inoperable pancreatic cancer to be converted to operable disease.   "
178401|NCT00178776|"     The purpose of this study is to determine the feasibility and promise of a recently     manualized group therapy based on the Transtheoretical Model for cocaine use disorders.   "
178418|NCT00179010|"     Adenosine and AMP are substances normally present in the body. Adenosine is also given for     the treatment of some heart rhythm problems and may be used to reduce heart damage during     heart attacks. The problem in using adenosine is that it is taken up by cells and, therefore,     very little of the adenosine we give by vein or in the artery actually reaches the tissue. We     propose to use AMP as a way to improve delivery of adenosine. AMP is inactive by itself, but     is converted to adenosine in tissue. We hope that by giving AMP we will increase levels of     adenosine in tissue. To see if this is true, we will give either adenosine or AMP into the     forearm artery while we measure how much adenosine reaches the forearm tissue.   "
178402|NCT00178789|"     Currently, most emergency physicians have limited access to obtaining formal radiology     ultrasound studies, particularly overnight. Many are forced to adopt risky and expensive     strategies in managing their patients with suspected deep venous thrombosis (DVT) who present     during off-hours: for low risk patients, discharging without anticoagulation and arranging     for outpatient studies; for moderate to high risk patients, empirically anticoagulating and     admitting to the hospital to await definitive testing. If emergency physicians could reliably     perform an accurate ultrasound exam for DVT, such risks could be obviated.      This is a prospective, observational cohort study assessing the accuracy of emergency     physician diagnosis of proximal DVT using compact ultrasound equipment and a simplified     compression technique. The value of color flow doppler and augmentation will also be     assessed. Outcomes (sensitivity, specificity, positive likelihood ratio and negative     likelihood ratio) will be assessed at 30 days.      Prior to enrolling patients in the study, emergency physicians will undertake a 2 hour     training course on the performance of the simplified compression technique for the diagnosis     of lower extremity DVT. Emergency physicians will perform the DVT ultrasound exam on study     subjects with suspected DVT. Clinical management of the study subjects will not be altered;     all subjects will proceed to receive a formal DVT ultrasound study by the radiology     department which will serve as the criterion reference for the study.   "
178403|NCT00178802|"     Thermal therapy (hyperthermia of heat) can increase the effect of chemotherapy treatments. By     itself, thermal therapy can also kill cancer cells. By using thermal therapy to treat the     whole body, the investigators can treat cancer cells wherever they are throughout the entire     body. In this study, the investigators are testing the combination of thermal therapy     combined with chemotherapy to see:        1. if it improves the effect of the chemotherapy drugs,        2. if it helps the body fight the cancer cells, and        3. if this treatment is safe for the patient.      This study does not offer heat treatment alone. Any patient with advanced or metastatic     breast, or endometrial cancer resistant to standard treatment may be treated with the phase     II protocol therapy; however, the patient will need to undergo some medical tests to make     sure this treatment would be safe for them.   "
178404|NCT00178828|"     The purpose of this study is to understand changes in brain chemical signals when people take     antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal     fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought     to be involved in depression. The study has potential to help understand and treat     depression.   "
178405|NCT00178841|"     The purpose of this trial is to determine if combination therapy with rosiglitazone and     bexarotene might have a synergistic effect in the treatment of patients with CTCL.   "
178406|NCT00178854|"     This is a study of the chemistry of depression in people who are taking an antidepressant but     it is not working well. The changes in brain chemicals that occur when an SSRI type     antidepressant is supplemented with risperidone (Risperdal®) will be studied. Spinal fluid is     used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be     involved in depression. The study has potential to help understand and treat depression.   "
178407|NCT00178867|"     A registry of patients with the diagnosis of hepatocellular carcinoma.   "
178408|NCT00178880|"     The purpose of the study is to identify and understand patterns of brain activity when people     are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI)     which does not involve any exposure to radioactivity or radioactive substances.   "
178409|NCT00178893|"     This is a registry of human hepatocytes (liver cells) for research purposes.   "
178410|NCT00178906|"     This project is focused on acoustical, sound, analysis of speech in order to identify vocal     characteristics of speech that are associated with suicidality. Speech samples will be     collected from four populations with different mental health status: suicidal, ideational     suicidal, depressed and those in remission from depression, (the control group). Speech of     subjects will be recorded during routine diagnostic interview sessions. The speech samples     will be acoustically analyzed via digital computer algorithms. The acoustical differences     among those groups will be determined based on the statistical analysis.   "
178411|NCT00178919|"     The amount of blood flowing to the different parts of the body is regulated by the autonomic     (automatic) nerves and by local factors produced by the blood vessels. Nitric oxide (NO) is     one of the most important of these metabolic factors. If the production of NO is slowed or     stopped the amount of blood to the different parts of the body is decreased. There is     increasing knowledge that NO mechanisms are impaired in a number of medical conditions. NO     function is reduced in patients with risk factors for atherosclerosis (hardening of the     arteries) such as hypercholesterolemia (patients with high cholesterol), or diabetes     mellitus, and is also impaired in smokers. This NO deficiency is believed to contribute to     the greater cardiovascular risk that marks these patient populations. This study is designed     to examine if endothelial nitric oxide is an important control mechanism of blood pressure     under normal conditions, and if impairment of nitric oxide contributes to hypertension.   "
178412|NCT00178932|"     The goals of this study are to replicate previous findings of genetic predictors of response     to clozapine and other antipsychotic drugs.   "
178413|NCT00178945|"     The purpose of this study is to investigate the use of injections of Botox (botulinum toxin     type A) for the treatment of chronic neck pain. Botox is an approved treatment for patients     with cervical dystonia. Cervical dystonia is a chronic condition characterized by involuntary     movements of the neck that are often painful. In this study, the response from Botox in     patients with neck pain not associated with cervical dystonia will be compared to the pain     response in patients with cervical dystonia.   "
178414|NCT00178958|"     The aim of this study is to evaluate the utility of continuous Holter ECG recording with     automated, computerized data analysis for measuring antipsychotic-related QTc prolongation     during a 24-h period under clinical conditions   "
178415|NCT00178971|"     Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who     have been treated with antipsychotic medications. Patients will be assigned to take active     medication (Buspar)or placebo along with their prescribed antipsychotic medication for six     weeks. Patients' memory and problem-solving ability will be tested before and after     medication.   "
178419|NCT00179023|"     In its simplest terms, obesity is the results of a positive balance between food intake and     energy expenditure (EE). I.e., we take in more energy, in the form of food, than we expend,     e.g., by exercise. In our sedentary society, resting EE accounts for most of total energy     expenditure. The sympathetic nervous system (SNS, the one that produces adrenaline) is     thought to contribute to resting EE. This conclusion is based on experiments where resting EE     is decreased by beta-blockers, high blood pressure medicines that block only one aspect of     the sympathetic nervous system. The investigators propose to use a different approach, by     using a medication called trimethaphan that produces transient withdrawal of the autonomic     nervous system. The investigators will then compare the measured resting EE before and after     SNS withdraw and quantify the degree of contribution to the resting EE by the SNS and     delineate differences between healthy normal, healthy obese, and patients with autonomic     dysfunctions.   "
178420|NCT00179036|"     The lack of blood flow to the small intestine causes mesenteric ischemia. Using a     Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the     small intestine, we are hoping to identify abnormalities without surgical intervention.   "
178421|NCT00179049|"     The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while     minimizing the complications of graft-versus-host disease.   "
178422|NCT00179062|"     This twelve month, open-label study considers the effect of Risperdal (risperidone) versus     Zyprexa (olanzapine) on weight gain, physical health, and outcome in a population of those     diagnosed with schizophrenia, schizoaffective disorder, major depression or bipolar disorder     with psychotic features. This study evaluates symptom response as well as general health     indicators such as body mass index, glucose, prolactin, and cholesterol levels at baseline,     month (M)1, M3, M6 and M12.   "
178423|NCT00179075|"     This is a repository to store blood and stem cell samples for future research.   "
178424|NCT00179088|"     The purpose of this study is to determine if full weight bearing following total hip     replacement can speed recovery when the hip replacement in the long bone of the leg is not     cemented into the bone. When cement is used, most surgeons allow full or nearly full weight     bearing following hip replacement. One drawback to cementless implants has been the     restriction of weight bearing for six to eight weeks after surgery, during which time     patients are allowed to only put their foot flat on the floor of the operated leg without     bearing weight on that leg. This study compares the effect of immediate weight bearing on the     speed of recovery from hip replacement surgery in two groups of patients receiving a     non-cemented total hip replacement: one group is randomly assigned to not bear weight, and     the other group is randomly assigned to allowed, tolerated weight bearing from the day of     surgery forward.   "
178425|NCT00179101|"     We will evaluate the effect of deep brain stimulation on the depression and quality of life     in Parkinson’s disease. We aim to compare depression pre-operatively and post-operatively in     Parkinson’s patients with deep brain stimulation to Parkinson’s patients evaluated and     approved for deep brain stimulation but who did not complete surgery. We will also compare     quality of life measures between patients with and without deep brain stimulation.   "
178426|NCT00179114|"     People with severe developmental disabilities frequently have comorbidities that make     providing care to them more difficult. Spasticity is one such comorbidity. It produces     increased muscle tone that can cause stiffness in joints and bodily contortions that can     interfere with all of the major types of care provided to participants. Typically, care areas     include splinting, hygiene, dressing, transfers, positioning, ambulation, and engaging in     other functional activities. Moreover, persons with spasticity often experience pain.      Typically, spasticity is managed by health care providers using a combination of the     following therapies:        -  Physical / occupational therapy (PT / OT)        -  Oral medication        -  Botox injections        -  Intrathecal baclofen administered by the Medtronic SyncroMed pump (ITB)        -  Orthopedic / neurological surgery   "
178427|NCT00179127|"     The purpose of this study is to determine the effects of the addition of insulin glargine     during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.      The investigators hypothesize that the addition of insulin glargine during the early phase of     management of DKA will accelerate acidosis correction, decrease the length of insulin     infusion, and decrease the total intensive care unit time in children admitted to the ICU.   "
178428|NCT00179140|"     The objective of this study is to determine how protein supplementation, with or without     exercise, affects functional capacity, strength, body composition, and physical activity in     hemodialysis patients.   "
178429|NCT00179153|"     We propose to identify malnourished chronic kidney dialysis patients through a statewide     effort and subsequently treat them based on a protocol (provision of oral nutritional     supplementation) over a period of six (6) months.   "
178430|NCT00179166|"     We hypothesize that a nutritional supplementation with higher than standard protein content     (2.0 gm/Kg/day vs 1.4 gm/Kg/day) will result in improved whole-body net protein balance when     administered to critically ill patients with acute renal failure (ARF).   "
178431|NCT00179179|"     To test the hypothesis that an exercise session combined with adequate nutritional     supplementation improves skeletal muscle protein accretion during a hemodialysis session.   "
178432|NCT00179192|"     Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the     largest single cause of morbidity in the chronic hemodialysis population, accounting for over     25% of hospitalizations at an estimated cost in the US of at least one billion dollars     annually. Currently, complication free survival of vascular access ranges between 30-50% a     year and multiple investigative efforts in this area have been initiated and are directed at     prolonging the functional life of vascular accesses.      It is not well established whether intervention prior to overt malfunction or thrombosis of     the vascular access could reduce these complications and thereby improve the functional     longevity of the access. Moreover, once accesses at potential risk are identified, it is not     well established which method of intervention, Surgery vs. Angioplasty vs. Expectant     Management, is superior in terms of clinical and financial outcome. The proposed study aims     to determine whether early intervention of a vascular access determined to be at risk of     malfunction and thrombosis improves the long term outcome and, specifically, which means of     intervention is preferred.   "
178435|NCT00179231|"     The study involves a six-month, double-blind protocol during which eighty patients, across     three sites around the country, will be randomly assigned to receive clozapine or olanzapine.     The specific aims of the study are to evaluate the relative effects of olanzapine and     clozapine on clinical outcomes and cognition in patients diagnosed with schizophrenia or     schizoaffective disorder who have demonstrated resistance to treatment in the past.   "
178436|NCT00179244|"     The purpose of this study is to evaluate the comparative effectiveness of Risperdal     (risperidone) or bupropion ER (extended release) combined with a SSRI medication and to test     the relative safety of the combinations.   "
178437|NCT00179257|"     The purpose of this is to determine the efficacy, safety, and tolerability of sertraline in     patients with major depressive disorder (MDD) who have shown inadequate response ot     escitalopram.   "
178438|NCT00179283|"     This is a randomized, double-blind, active control, 8-week, flexible dose study of sertraline     vs. venlafaxine Extended Release in the acute treatment of Major Depression in male and     female outpatient sites that will recruit 15-20 patients each. Subjects will be randomized in     a 1:1 ratio to receive either sertraline or venlafaxine XR based on a computer-generated     randomized list.   "
178439|NCT00179309|"     This study will test whether giving a combination of a vaccine together with docetaxel is     more effective against breast cancer than docetaxel alone. The Food and Drug Administration     has approved docetaxel to treat many cancers, including breast cancer. The vaccine consists     of three parts: 1) a priming vaccine called PANVAC (PAN (all) VAC (vaccine)) trademark     [TM]-V, which is made from vaccinia virus; 2) a boosting vaccine called PANVAC[TM]-F, made     from fowlpox virus; and 3) sargramostim, or granulocyte macrophage colony stimulating factor     (GM-CSF), a protein that may help boost the immune system. Human genes are inserted into the     vaccinia and fowlpox viruses to cause production of carcinoembryonic antigen (CEA) and mucin     1 (MUC-1)-two proteins that are often produced by cancer cells and can be used as a target     for the immune system to attack the cancer. Another type of deoxyribonucleic acid (DNA) is     inserted to cause production of other proteins that enhance immune activity.      Patients 18 years of age or older with metastatic breast cancer (disease that has spread     beyond the original site) and whose cancer produces CEA or mucin 1 (MUC-1) protein may be     eligible for this study. Patients must have antigen type human leukocyte antigen A2 (HLA-A2).     They may have received adjuvant docetaxel treatment at least 3 months before entering this     study, prior hormonal therapy and up to three chemotherapy regimens. Candidates are screened     with a medical history and physical examination, blood and urine tests, electrocardiogram,     and computerized tomography (CT) or magnetic resonance imaging scans.      Participants are randomly assigned to one of two treatment groups - docetaxel alone or     docetaxel plus vaccine - as follows:      Docetaxel Alone      All patients receive docetaxel. The drug is infused through a vein over 30 to 60 minutes once     a week for 3 consecutive weeks with 1 week off drug. Patients also take dexamethasone 12     hours and 1 hour before and 12 hours after the docetaxel to help prevent fluid retention     (edema) that docetaxel may cause.      Docetaxel Plus Vaccine      Participants receive the priming vaccination followed by monthly boosting vaccinations, along     with the weekly docetaxel therapy. With every vaccination, patients also receive an injection     of sargramostim to increase the number of immune cells at the vaccination site. Sargramostim     injections are given the day of vaccination and daily for the next 3 days. All vaccine and     sargramostim doses are given as injections under the skin, usually in the thigh. Patients are     observed in the clinic for 1 hour after each injection.      Patients have blood tests every four weeks to monitor drug side effects and before every     vaccination to check blood counts. A bone scan or CT scan (or both) is done every 2 to 3     months to check the response to treatment.      Patients may continue receiving treatment as long as their disease does not worsen and they     can tolerate the treatment without significant side effects. Patients assigned to receive     docetaxel alone whose disease progresses after 3 months on the drug may choose to receive the     vaccine or come off the study to receive other treatment options. Patients are monitored with     yearly telephone calls for up to 15 years.   "
178440|NCT00179322|"     This study will measure brain activity in individuals performing language tasks while in     various states of alertness to learn more about how the central nervous system is affected by     impairments such as sleepiness.      Healthy normal volunteers between 20 and 40 years of age may be eligible for this study.     Candidates must be non-smokers, right-handed, speak English fluently and have at least 12     years of education. They are screened with a medical history, physical examination, hearing     and speech evaluation, computer task training, blood and urine tests and a late-night     functional magnetic resonance imaging (fMRI) scan (see description below). Before screening     and again before participating in the study, candidates wear an actigraph (a wristwatch-like     device that records motion) for 7 days to provide a measure of their sleep-wake patterns.      Participants undergo the following tests and procedures:        -  Extended wakefulness: Subjects are kept awake longer than is normal for them in their          everyday life to be able to examine the brain under conditions of sleepiness. They are          engaged in activities with the research staff during this waking time.        -  Functional magnetic resonance imaging: Subjects undergo five separate fMRI scans-one          during screening and four others during the main part of the study. fMRI uses a magnetic          field and radio waves to produce images of the brain. The subject lies on a table that          is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking          and thumping sounds that occur during the scanning process. Brain scans are taken at          rest and while the subject performs tasks, which include pressing a button upon seeing          certain shapes and performing various language tasks, such as saying memorized or new          words, listening to narratives, and describing everyday procedures.        -  Neurological, speech-language, and neuropsychological testing: Before the fMRI exams and          during the period of extended wakefulness, subjects complete a series of tests that          measure speech, language, memory and visual skills. Portions of the tests may be video-          or autiotaped.        -  Interviews and questionnaires: Participants are interviewed about their handedness,          sleep history, and presence of medical or neurological symptoms.        -  Electrophysiological studies: Subjects have an electroencephalograph (EEG) to measure          the electrical activity of the brain and surface electromyography (EMG) to measure          movements of muscles involved in moving and speaking. For the EEG, electrodes (small          metal disks) are attached to the surface of the scalp or to a cap placed over the head.          For the EMG, electrodes are attached to the skin of the face and neck by plastic or          paper tape.   "
178441|NCT00179335|"     HIV infected patients, aged </= 35 years and aged >/= 55 years, who are regularly taking     either efavirenz (EFV) or lopinavir/ritonavir (Lop/r) as part of their antiretroviral regimen     are being asked to spend 12 hours at the researchers' clinic (the ACS clinic at Jacobi     Medical Center, Bronx, New York) for an intensive pharmacokinetic study in which 5 cc of     blood will be drawn 9 times over a 12 hour period. Patients taking EFV will return for one     additional blood draw the following day.   "
178442|NCT00179348|"     This clinical trial studies yoga-based rehabilitation in reducing physical and emotional side     effects of living with cancer or its treatment. Yoga-based rehabilitation may reduce side     effects and improve the quality of life of patients with breast, lung, or colorectal cancer.   "
178443|NCT00179361|"     Oro-pharyngeal cancers can develop from squamous dysplastic precursor lesions, which occur in     a subset of common white (leukoplakia), red (erythroplasia), or mixed oro-pharyngeal plaques.     Known risk factors for oro-pharyngeal cancer include tobacco smoke, alcohol consumption, diet     and, in a subset of tumors, human papillomavirus (HPV). Along the oro-pharyngeal disease     continuum, there may be variations in gene expression precursor lesions as a result of     exposure to smoking, alcohol and HPV. However, the components of gene expression that are     most likely associated with tumorigenesis in these tissues are poorly understood. This study     will focus upon early gene expression profiles in the oral cavity and oropharynx in subjects     who have precursor lesions and have been exposed to the common risk factors for carcinoma     development including smoking and HPV infection. This application is to conduct pilot testing     and establish appropriate procedures for an international prospective cohort study of the     natural history of oro-pharyngeal cancer precursors among men and women at high risk of     oro-pharyngeal cancer at Montefiore Medical Center, Bronx-NY. Brush biopsy specimens will be     used to collect a transepithelial sample of cells from oro-pharyngeal plaques, as well as     normal tissue from defined regions of the oral and pharyngeal mucosa. Measurement of gene     expression will employ novel high-throughput cDNA microarray analysis and PCR-based HPV DNA     testing. Oro-pharyngeal dysplasia will be diagnosed using cytopathology. Under this     application, we will assess our planned instruments and procedures on an initial sample of 40     subjects. This planning period will allow for precise identification of methodologies,     standardization of instruments and assays to be utilized by additional participating centers     in a subsequent application.   "
178444|NCT00179374|"     This study has the following specific aims:        1. A tailored telephone intervention will significantly improve medication adherence          compared to a standard care intervention.        2. A tailored telephone intervention will significantly improve metabolic control measured          by HbA1c compared to a standard care intervention 2a) We will explore ways to link          behavior change for medication adherence with lifestyle modification for diet and          physical activity.        3. To conduct cost evaluations for the telephone intervention vs. standard care.   "
178445|NCT00179387|"     The purpose of this study is to find out if Mind-Body groups can help improve the physical     and emotional well-being of people facing cancer or its treatment.   "
178447|NCT00179413|"     In this study Peg-Intron will be tested to see if it will give better results than     Colchicine. At this time, there is currently no recommended maintenance treatment for     patients who have failed to respond to Interferon/Rebetron/Peg Intron and have advanced     fibrosis. The purpose of this study is to compare two treatments to slow down the progression     of liver disease and to prevent liver failure and liver cancer. The treatment will not cure     Hepatitis C, but is being evaluated to see if it can slow down disease progression.   "
178451|NCT00179465|"     The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during     the early course of schizophrenia can fundamentally correct the brain deficits associated     with the disease.      This study is funded by the National Institutes of Health.   "
178452|NCT00179478|"     The current study is an extension of the previous phase III CHAMPS study (see reference).     This study was designed to determine if immediate initiation of therapy with Interferon     Beta-1a (AVONEX) after a first attack of multiple sclerosis continues to delay the     development of further attacks and the development of neurological disability over a 10 year     period of observation.   "
178453|NCT00170820|"     The purpose of this study is to assess if a combination of everolimus, steroids, and     mycophenolate mofetil is associated with a better renal function than sirolimus.   "
178454|NCT00171366|"     Comparison of the safety and efficacy of the combination of amlodipine/Benazepril to     amlodipine monotherapy in patients with non-essential hypertension, not controlled on     amlodipine alone.   "
178455|NCT00171379|"     The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF     to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.   "
178456|NCT00171392|"     The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate     sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to     enteric-coated mycophenolate sodium in stable renal transplant patients.   "
178457|NCT00171405|"     The purpose of this study is to collect the long-term (12 months) safety data on aliskiren     300 mg when taken in combination with HCTZ 25 mg.   "
178458|NCT00171418|"     Study to assess the effects of adding tegaserod to PPI therapy results in clinically     meaningful improvement of GERD symptoms in patients with incomplete relief of symptoms on     daily PPI therapy alone.   "
178459|NCT00171431|"     Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern     in female IBS-C patients.   "
178460|NCT00171444|"     The purpose of the study is to determine whether a specific training of General Practitioners     (Family Physicians) regarding the new official guidelines for the treatment of hypertension     results in a higher control of high Blood pressure in their patient population.   "
178461|NCT00171457|"     Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention     of the stomach   "
178462|NCT00171470|"     Study to provide initial data to assess the safety and efficacy of tegaserod use in patients     with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.   "
178463|NCT00171483|"     Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn     and regurgitation in patients with incomplete relief from PPIs .   "
178464|NCT00171496|"     The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine     microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and     safety in preventing organ rejection   "
178465|NCT00171509|"     The purpose of this study is to determine whether cyclosporine microemulsion given once a day     instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose     control in stable liver transplant recipients. The study also aims to identify the target     ranges of levels of cyclosporine microemulsion in the blood.   "
178466|NCT00171522|"     To determine whether female patients have a preference for tegaserod of PEG 3350 relative to     dosage form, convenience, ease of administration and taste   "
178467|NCT00171535|"     This study will assess the effectiveness and safety of different combination antihypertensive     treatments in patients with severe hypertension   "
178468|NCT00171548|"     Metabolic syndrome is commonly defined as a set of risk factors and abnormalities that     markedly increase the risk of cardiovascular events. Its relevance has been confirmed by a     recent population-based survey of subjects aged 40-79 years indicating that the prevalence of     metabolic syndrome in Italy is 34.1% if diagnosed using WHO criteria and 17.8% if diagnosed     using the NCEP-ATPIII criteria.      On the basis of the above considerations, the aim of this study is to promote the use of the     SCORE algorithm for estimating cardiovascular risk, and to evaluate its evolution in patients     with metabolic syndrome after the implementation of a multifactorial preventive strategy,     with particular reference to the correction of lifestyle, hypertension and dyslipidemia.   "
178469|NCT00171561|"     The purpose of this study is assess if treatment with valsartan and a diuretic,     hydrochlorothiazide, has beneficial effects in people with high blood pressure, diabetes, and     albuminuria (protein in the urine) compared with amlodipine. In particular, the study will     assess whether the treatment will decrease the stiffness of the blood vessels.   "
178470|NCT00171574|"     Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in     non-diabetic and diabetic renal disease: a randomized (3:3:1), double blind, parallel group,     controlled trial, 5 months follow-up.      Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo     treatment in no-diabetic and diabetic patients.      Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin     ratio more than monotherapies.      Design: Multicentric, randomized, double blind, parallel group, active controlled.      Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20   "
178493|NCT00171873|"     Placebo-controlled prospective randomized phase III study to investigate the     antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of     the midgut   "
178471|NCT00171587|"     The objective of this study is to assess the safety, tolerability, dose limiting toxicity,     and maximum tolerated dose of vatalanib administered orally once daily in combination with     capecitabine in patients with advanced cancer. The study is also designed to determine the     effect of vatalanib on the pharmacokinetics of capecitabine and the effect of capecitabine on     the pharmacokinetics of vatalanib, and to describe the anti-tumor activity of this     combination regimen.   "
178495|NCT00171899|"     The study will assess the role of high-dose imatinib mesylate, in patients who have taken     imatinib mesylate for at least 1 year at the standard dose, in achieving a major molecular     response (a measure of the level of chronic myelogenous leukemia) versus the standard dose.   "
185088|NCT00268879|"     The purpose of the study is to investigate whether renzapride will help alleviate the     symptoms associated with constipation predominant irritable bowel syndrome in female     patients.   "
178472|NCT00171600|"     Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in     non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group, 20     weeks follow-up.      Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril vs     combo treatment in non-diabetic and diabetic patients.      Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more     than monotherapies..      Design: Multicentric, randomized, open label, parallel group, active controlled.      Dose / regimen: Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20      Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus     lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up.     Description % of change in albuminuria from baseline at 20 weeks.      Secondary Endpoint : To investigate the effect of 5 months treatment with     valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to     investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus     lisinopril on blood pressure and the effect on left ventricular mass index using     electrocardiogram and Cornell-Sokolow method.   "
178473|NCT00171613|"     The extension protocol is designed to allow those patients randomized to placebo in the core     portion of the protocol to receive a 6 month treatment of open label octreotide and allow     those patients randomized to octreotide who appeared to benefit from treatment, to continue     to receive octreotide.   "
178474|NCT00171626|"     This study will test the efficacy and safety of topical diclofenac sodium gel in the     treatment of knee osteoarthritis.   "
178475|NCT00171639|"     This study is being conducted to evaluate the effect of an investigational drug on bone loss     in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT).      In order to participate, male patients 18 years and older must be veterans from participating     Veterans Administration Medical Centers that are receiving ADT for prostate cancer and have     established osteoporosis.   "
178476|NCT00171652|"     This study will test the efficacy and safety of topical diclofenac sodium gel in the     treatment of hand osteoarthritis.   "
178477|NCT00171665|"     This study will test the efficacy and safety of topical diclofenac sodium gel in the     treatment of hand osteoarthritis.   "
178478|NCT00171678|"     This study will test the efficacy and safety of topical diclofenac sodium gel in the     treatment of knee osteoarthritis.   "
178479|NCT00171691|"     This study will test the efficacy and safety of topical Voltaren in the treatment of knee     osteoarthritis.   "
178480|NCT00171704|"     Estrogen is known to be a regulator of bone and lipid metabolism. Letrozole is a potent     inhibitor of estrogen synthesis.      This study evaluated the effects of letrozole and tamoxifen on bone and lipid metabolism in     postmenopausal women with resected, receptor positive early breast cancer.   "
178481|NCT00171717|"     The trial is conducted in patients who have received a liver transplant, were prescribed     tacrolimus to prevent organ rejection and developed diabetes from 3 month     post-transplantation onwards. The goal of the trial is to assess the percentage of patients     in whom diabetes will resolve 6 month after conversion from tacrolimus to cyclosporine     micro-emulsion as measured by a fasting blood glucose < 1,26 g/l without the need of     hypoglycemic treatment.   "
178482|NCT00171730|"     Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth     hormone (GH), generally caused by a GH-secreting pituitary adenoma. This study will assess     the long-term safety and efficacy of pasireotide in patients with acromegaly.   "
178483|NCT00171743|"     The purpose of this study is to determine whether the switch from tacrolimus to cyclosporine     microemulsion benefits post-transplant diabetes management (in terms of glycogenic control     and insulin dosage) in stable liver transplant recipients.   "
178484|NCT00171756|"     A study to compare the effects of Diovan or Atenolol taken for 12 weeks on platelet function     of patients who have mild to moderately severe hypertension   "
178485|NCT00171769|"     This trial is designed to provide data about feasibility and safety of short-term treatment     with the low-molecular-weight heparin certoparin in patients with persistent nonvalvular     atrial fibrillation   "
178486|NCT00171782|"     A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2     hypertension and cardiovascular risk factors.   "
178487|NCT00171795|"     This study is designed to investigate the efficacy and safety of rivastigmine compared with     placebo in patients with traumatic brain injury and cognitive impairment.   "
178488|NCT00171808|"     In Western industrialized countries, endometrial cancer is the most common malignancy of the     female reproductive tract.      The general therapy options are surgery, radiotherapy, chemotherapy and endocrine therapy.     This trial will investigate the efficacy and safety of letrozole in the treatment of advanced     or recurrent hormone receptor-positive endometrial cancer .   "
178489|NCT00171821|"     This study uses a single arm, multi-center, open-label trial design. The study will assess     the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with     evidence of transfusion induced iron overload.   "
178490|NCT00171834|"     The study objective is to evaluate the maximum tolerated dose, safety and efficacy of     patupilone in patients with NSCLC who have progressed after prior chemotherapy.   "
178491|NCT00171847|"     Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in     metastatic breast cancer patients   "
178492|NCT00171860|"     The objectives of the study are:        1. Evaluation of the safety profile of imatinib mesylate in patients with idiopathic          hypereosinophilic syndrome resistant or refractory to, or intolerant of, prednisone,          hydroxyurea or interferon-alpha, or untreated patients carrying the Fip1L1-PDGFRA fusion          protein.        2. Evaluation of the efficacy of imatinib mesylate in patients with idiopathic          hypereosinophilic syndrome        3. Analysis of patient's blood samples for the detection of activated kinases.   "
178494|NCT00171886|"     Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH)     hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is     associated with bony and soft tissue overgrowth. Goals of therapy are to eradicate the tumor,     suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function.      This study will evaluate the safety and efficacy of octreotide as primary therapy for the     treatment of acromegaly and as therapy for patients with acromegaly and a pituitary     macroadenoma or microadenoma.   "
178496|NCT00171912|"     This trial is for various types of malignancies which may depend on certain enzymes (tyrosine     kinases) for growth. The objective of this study is to assess to what extent imatinib     mesylate blocks these enzymes and to assess the effect on the malignancy.   "
178497|NCT00171925|"     Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant     plasma cells induce osteolytic lesions, which is characteristic for progression of multiple     myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence     on the progression of multiple myeloma.   "
178498|NCT00171938|"     This is an open label clinical trial of imatinib mesylate 800 mg po/day in a population of     patients with unresectable, recurrent glioblastoma multiforme. Patients will be treated for     up to 12 months   "
178499|NCT00171951|"     Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic     hormone (ACTH) secreting pituitary adenoma. This study will assess the long-term safety and     efficacy of pasireotide in patients with Cushing's disease.   "
178500|NCT00171964|"     It is the aim of this multicentric clinical study to assess the efficacy and tolerability of     zoledronic acid in combination with radiotherapy in patients with advanced osteolytic bone     lesions in terms of the reduction of pain and analgesic consumption.   "
178501|NCT00171977|"     This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of     postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative     resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as     measured by the confirmation of tumor recurrence and survival for 3 years after surgery for     their primary tumors.   "
178502|NCT00171990|"     This is a phase III, multicenter, randomized, double-blind, parallel-group study to compare     the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed     by 250 mg 12-hourly) to standard five-day treatment with famciclovir (125 mg 12-hourly) in     patients with active recurrent genital herpes.      This study is not recruiting patients in the United States.   "
178503|NCT00172003|"     It is the aim of this clinical study to evaluate the skeletal-related event rate under     therapy with zoledronic acid in patients with renal cell cancer having at least one     cancer-related bone lesion.   "
178504|NCT00172016|"     The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in     preventing skeletal-related events in patients with prostate cancer   "
178505|NCT00172029|"     The aim of this prospective, randomized, open-label, multicentric clinical study is to assess     the effícacy and tolerability of zoledronic acid 4 mg IV infused over 15 minutes every 4     weeks for a total of 6 infusions, in combination with standard or reduced dose radiotherapy     in patients with breast cancer and metastatic bone disease associated with pain.   "
178506|NCT00172042|"     30-40% of patients with lung cancer will develop bone metastases during the course of their     disease, which can lead to pain, decreased mobility and skeletal complications. This study     will investigate the effect of zoledronic acid on preventing or delaying the development of     bone metastases and the impact on disease progression/survival in patients with stage IIIA     and IIIB Non-small Cell Lung Cancer (NSCLC).   "
178507|NCT00172055|"     The objective of the study is to investigate whether blood markers can be used to predict the     development of bone metastases and to assess the efficacy and safety of zoledronic acid in     cancer treatment induced bone loss.   "
178508|NCT00172068|"     Metastatic bone disease is an important prognostic factor for survival which will in median     be close to two years after first diagnosis of osseous metastases. This open-label study will     investigate the safety and efficacy of zoledronic acid in patients with breast cancer and     minimal residual disease in the bone marrow.   "
178509|NCT00172081|"     This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month     interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84)     (rhPTH [1-84]), on fracture incidence in women with postmenopausal osteoporosis, the TOP     study.   "
178510|NCT00172094|"     The purpose of this study was to evaluate the effectiveness and safety of a single oral dose     of NPS 1776 in the acute treatment of migraine pain and associated symptoms.   "
178511|NCT00172107|"     A double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of     3 doses of ALX1-11 (recombinant human parathyroid hormone [rhPTH(1-84)])(50, 75 and 100 µg)     in the treatment of postmenopausal osteoporosis. The primary objective of this study is to     compare the efficacy of ALX1-11 (50, 75 and 100 µg) with that of placebo in terms of     increasing vertebral bone mineral density, when given daily by subcutaneous injection for 12     months in postmenopausal women with osteoporosis.   "
178512|NCT00172120|"     TRES will evaluate the effects of continued ALX1-11 treatment on the safety and efficacy     variables assessed in the OLE study for a maximum treatment duration of 36 months in OLES and     TRES combined.   "
178513|NCT00172133|"     This is an Open Label Extension Study (OLES) for patients who participated in the 18 month     double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study)     studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on     vertebral fracture incidence. The primary objective of this study is to evaluate the safety     of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal     osteoporotic women who participated in Protocol ALX1 11 93001.   "
178514|NCT00172146|"     The purpose of this study was to examine the influence of cane use on the movement, kinetics,     and associated attentional demands of performing a voluntary forward stepping movement in     patients with stroke and age-matched healthy adults.   "
178522|NCT00172250|"     Elevation of plasma homocysteine has been recognized as one of the risk factors of     atherosclerotic disease. The objectives of this study are: (1) to investigate the level of     plasma homocysteine and the prevalence of hypehomocysteinemia (2) to find out the role of     homocysteine in coronary artery disease and the proper cut-off point of plasma homocysteine     to evaluate the presence of coronary artery disease; (3) to understand the control condition     of tranditional risk factors of cardiovascular disease, especially hypertension,     dyslipidemia, and diabetes mellitus.      The study subjects were recruited from the ambulatory setting of cardiology in National     Taiwan University Hospital.   "
185782|NCT00277212|"     Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance     Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode   "
178515|NCT00172159|"     More and more colorectal surgeons believe that surgical resections of hepatic metastases from     colorectal cancer is the only chance for cure of patients. The five-year survival for     patients with hepatic metastasis from colorectal cancer after surgical resection is     approximately 30 %. However, most hepatic metastases from colorectal cancer were inoperable.     With the progress of chemotherapy, for example, the combination of the 5-Fu, leucovorin, and     oxaliplatin, some surgeons advocated that approximately 20% of inoperable liver metastases     will be converted to operable case, thus providing the long-term survival for patients. In     this study, we made a phase Ⅱ clinical trial regarding the use of the Folfox-4 regimens in     the neo-adjuvant treatment of inoperable hepatic metastases. Our aims is to evaluate the     tumor response rate for this regimen, the rate of resectability of liver metastases,     progression free survival and overall survival of patients. In addition, the difference     between the reports from Western and Oriental countries will be analyzed. We believe this     study will provide new perspectives regarding the most beneficial treatment modalities for     the patients with hepatic metastases from colorectal cancer.   "
178516|NCT00172172|"     This study is evaluating the effects of calcium supplementation on the efficacy and safety of     recombinant parathyroid hormone (ALX1-11) in postmenopausal women with osteoporosis. The     primary objective of this clinical study is to evaluate whether increases in bone mineral     density (BMD) for subjects treated with ALX1-11 and receiving no calcium supplementation are     less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium     supplementation.   "
178517|NCT00172185|"     The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily     administration of teduglutide.   "
178518|NCT00172198|"     1. A prospective, controlled, randomized, study evaluating the clinical efficacy, including          nutritional status, immune function and safety of Omegaven (ω-3 fish oil) supplemented          parenteral nutrition in subjects of SICU.        2. Study patients are the critical ill patients in SICU of NTUH and the enrolled patients          will be 30 subjects ,including 15 in each treatment group.        3. During parenteral nutrition, fat emulsions will be given separately from amino acid and          glucose solutions. Infusion pump must be used.The recommended infusion duration of the          daily lipid emulsion is 16 hours (0.0625 g fat/kg B.W./hour) from 8:00 am to 12:00 pm.        4. During the study the assessments of safety and efficacy are to be performed according to          case report form. The assessment for safety variables including blood pressure、heat rate          、body temperature、liver function、renal function、coagulation、WBC、lipid profile etc. In          addition，the assessments for efficacy variables including          lymphocytes、cytokines(IL-1、IL-2、IL-6、IL-8、IL-11、IL-18、OX40          ligand、G-CSF、FN-γ、TGF-β1、TNF-α etc)、incidence of infections、 length of ICU and hospital          stay、mortality etc.   "
178519|NCT00172211|"     Patients affected by end-stage renal disease (ESRD) are subjected to enhanced oxidative     stress, as a result of reduced anti-oxidant systems and increased pro-oxidant activity.     Besides, insulin resistance is also very common in ESRD patients. Both enhanced oxidative     stress and insulin resistance increase the risk of atherosclerosis and cardiovascular     mortality, and intention to reduce oxidative stress and insulin resistance is important in     ESRD patients who suffer from high cardiovascular risk.      The high concentration of glucose and glucose degradation products (GDP), high lactate, and     low pH in conventional peritoneal dialysis (PD) solutions are known as bioincompatible     factors, which are believed to increase oxidative stress in PD patients. Physioneal®, a more     biocompatible dialysis solution with neutral pH, physiologic bicarbonate concentration and     low GDP level, has been applied in Europe for several years. Previous studies of Physioneal®     have revealed advantages of improved infusion pain, more efficient acid-base control,     increased ultrafiltration, and reduced peritonitis duration. However, its effects on     oxidative stress and insulin resistance in peritoneal dialysis patients are not reported yet.     The comparison of oxidative stress and insulin resistance before and after using Physioneal®     may help to elucidate the possibly beneficial effects on uremic patients, which frequently     suffer from increased oxidative stress and insulin resistance.      Thirty continuous ambulatory peritoneal dialysis (CAPD) patients will be selected in this     study, and receive conventional solution (Dianeal® PD-2 or PD-4) for a baseline period of 3     months. Then Physioneal® will be used for 3 months. Clinical conditions, biochemical and     hematological parameters, oxidative markers in blood and effluent, and insulin resistance     will be measured at baseline, before and after Physioneal®, and some markers will be measured     1 month after discontinuing Physioneal® and changing back to conventional solution. The     medication used in each patient will be recorded, and the dialysis prescription will be     adjusted by a nephrologist according to clinical data. The data collected before and after     Physioneal® will be analyzed by paired-t test.   "
178520|NCT00172224|"     The etiology and pathogenesis of osteoporosis has been extensively discussed. The     relationship between bone blood circulation and the formation of bony trabeculae has been     less understood. There is plenty of indirect evidence highly suggestive of the correlation     between these two factors, such as: the number of blood vessels in the per unit area of the     bone marrow was decreased in the osteoporotic bone, indicating the possible role of a     microvascular defect in the pathogenesis of osteoporosis.      Furthermore, the bone mineral density in severe arteriosclerotic patients was lower than in     the less affected subjects. In a large scale epidemiologic study, diminished bone mineral     density was strongly associated with increased deaths from stroke. Osteopenia was also     associated with an increased risk of stroke. These reports highly suggest the effect of     ischemia on bone metabolism and make the investigators more interested in further     investigation.      A dynamic contrast-enhanced magnetic resonance (MR) study was used recently in evaluating the     blood perfusion of bone tumors. This method also has a strong correlation with the     microsphere blood flow measurements. The investigator (T.F. Shih) used the dynamic MR in her     recent two researches:        1. To differentiate benign versus malignant spinal compression fractures.        2. To evaluate the blood perfusion of non-fractured, normal-appearing vertebral bodies and          find its significant correlation with aging and sex.      The alterations of bone marrow perfusion are synchronous with the changes of bone mineral     density. Thus, based on the investigators' previous research work, they propose to further     explore the relationship between bone marrow perfusion and bone mineral density in different     age groups.   "
178521|NCT00172237|"     Specific aims of this project were as follows:        1. To investigate the eye-head coordination of patients with cervical spine degeneration.        2. To investigate the relationship of these impairment measurements (range of motion,          muscle power, proprioception, sensory threshold, eye-head coordination) and functional          outcome (neck disability index, quality of life evaluation).        3. To develop a computer assistant device and software for the proprioceptive training and          eye-head coordination.        4. To provide a treatment and prevention program emphasized on proprioception treatment and          coordination for employee with neck-shoulder complaints.   "
178822|NCT00182832|"     The purpose of this study is to evaluate the effectiveness of a cognitive screening program     coupled with a computerized decision support system in improving the quality of care for     hospitalized older adults with cognitive impairment.   "
178523|NCT00172263|"     Severe acute respiratory syndrome (SARS) is a new threat to public health since November,     2002. The SARS is highly contagious and is believed to be transmitted by person-to-person     through droplet and direct contact. The patients present with fever, chills, cough, myalgia,     dyspnea, and diarrhea. The symptoms aggravate in the second week and nearly 40% of the     patients develop respiratory failure that requires assisted ventilation. The mortality rate     is reported as 6.5%-7%.      After several months, the world scientists found the etiology to be a new coronavirus not     belonging to the previous coronavirus group I, II and III. The new virus is called SARS     associated coronavirus (SARS-CoV).      Although the high morbidity and mortality of SARS occurred in adults, there was rare     mortality reported in the children. The report from Hong Kong pointed out that the symptoms     of SARS in younger children were milder and the clinical course was not as aggressive as in     adults. Therefore, the aim of the project is to design the experiment to see the differences     of immunological responses to SARS-CoV protein in healthy younger children, teenagers, and     adults. The investigators hope that the result could explain the reason for milder disease in     younger children and the immunological pathogenesis of SARS.   "
178524|NCT00172276|"     Aims This study was conducted to examine the association between the ACE insertion/deletion     (I/D) genotype distribution in children with idiopathic nephrotic syndrome and the response     to steroid therapy.      Patients and Methods The patients with idiopathic nephrotic syndrome were divided into 2     groups according to their clinical response to steroid: SS group including infrequent and     frequent relapsers and non-SS group including steroid resistant (SR) and steroid dependent     (SD) patients. Children without previous renal diseases and negative proteinuria were     enrolled as control group in genetic study. The genotypes for ACE gene I/D polymorphism     including DD, ID and II were analyzed by the newly developed automatic denaturing high     performance liquid chromatography system (DHPLC).   "
178525|NCT00172289|"     According to the theory of wave transmission, the speed of wave transmission is dependent on     the nature of the transmission medium, which is the vessel wall for pulse wave transmission.     Then, the pulse wave velocity is related to the mechanical property of the vessel wall. The     mechanical property of the vessel wall is determined by the texture of the vessel wall and     the contraction status of the smooth muscle within the vessel wall. Because the texture of     the vessel wall could not be changed in a short duration, the sympathetic nerve activity,     which controls the contractibility of the smooth muscle, becomes the only determinant factor     of pulse wave velocity. So, pulse wave velocity may reflect the status of sympathetic nerve     activity. The purpose of this project is to use the pulse wave velocity to measure the     sympathetic activity of stroke and spinal cord patients. The present project plans to measure     the pulse wave simultaneously at four limbs by pressure receptors, and use the     electrocardiogram as the reference to synchronize the recorded pulse wave at different     vessels, using the corrected data to calculate the pulse wave velocity. With the pulse wave     velocity of different vessels, we, the investigators at National Taiwan University Hospital,     can understand the local sympathetic nerve activity in different diseases and different     sites.      The first year, we will set up the equipment for measuring the pulse wave velocity, and then     apply it to 20 healthy subjects to adjust the measurement error and ascertain the     reproducibility of the machine. The second year, we will apply the measurement to 15 complete     cervical cord injury individuals and 15 healthy subjects in different erected angles by a     tilting table. This procedure will make us understand the response of sympathetic nerve     activity to different postures in normal subjects and cervical cord injury patients. The     third year, we will apply the measurement to 30 cerebrovascular accident patients to     understand the change of sympathetic nerve activity after having a stroke. By comparing the     clinical information, we hope to clear up the relationship between sympathetic nerve activity     and pulse wave velocity.   "
178526|NCT00172302|"     Intravenous vitamin C may improve skin hyperpigmentation in chronic hemodialysis patients   "
178527|NCT00172315|"     Magnetic resonance spectroscopy (MRS) is commonly applied in medicine with 1H proton or     31-phosphorus spectra. The proton MRS is often used in evaluating the central nervous system     and 31P MRS is used in muscular diseases or neoplasms. However, the proton MRS is also     considered to be applied to the musculoskeletal system because of its profound amount of     protons. Ballon used the STEAM technique, and Schick used the PRESS technique, to investigate     the lipid and water spectra of the bone marrow and also correlated those with hematological     diseases and post-treatment effects. Schellinger et al. used the STEAM sequence to calculate     the lipid content of the vertebral bone marrow and found that it was influenced according to     age and sex. The investigator had used the proton MRS to evaluate the lipid and water spectra     of the femoral head and revealed its significance in predicting avascular necrosis of the     femoral head. According to the above research literature, the investigators considered     further investigation of the proton MRS in evaluating the musculoskeletal system.   "
178528|NCT00172328|"     Taiwan is an endemic region for hepatitis B. Before the implementation of a nationwide     vaccination program in 1984, the hepatitis B virus (HBV) carrier rate in the general     population was 15 to 20%.1-2 The major impact of hepatitis B (HB) infection is its long-term     sequelae which may include chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma.3     Perinatal infection accounts for 40-50% of all hepatitis B infections and is responsible for     the generation-to-generation transmission of HB virus.4 Hepatitis B vaccines, both plasma     derived and recombinant, are highly immunogenic and efficacious.5-10 It has been reported     that HB vaccine given soon after birth is able to protect infants from perinatal infection     and HB infection became the first disease model to show that mother-to-neonate transmission     can be interrupted by an effective vaccine.11 Taiwan started a national program of HB     vaccination since 1984. This program resulted in a significant reduction of the HB carrier     rate in children aged below 10 years from 9.8% before nationwide vaccination to 1.3% after     the program.12 It also decreased the incidence of hepatocellular carcinoma in children aged 6     to 9 years from 0.52 to 0.13 per 100,000.13 However, the duration of protection provided by     the HB vaccine and the proper timing of a booster dose remains unclear. Because the HB     vaccine is a subunit protein vaccine, which contains only HBsAg, a limited duration of     protection is anticipated. The results of several long-term follow-up studies of the     protective efficacy of HB vaccination have been published. Soon after vaccination, protective     levels of antibody (anti-HBs >10 mIU/mL) can be detected in the great majority (83-99%) of     vaccinees.5-7 The proportion of vaccinees with protective anti-HBs levels decreases to 75-87%     5 years after vaccination and further drops to 50 to 70% 10-12 years after.10,11,14,15,19-21     Because of the progressive decline of anti-HBs and the associated increased likelihood of     development of new HBV infections, some investigators advise the use of a booster     vaccination.20,21 However, a preponderance of data indicates that the protective efficacy of     the HB vaccine can last for at least 5 to 10 years and a booster before 5 years is not     necessary.16-18,22,23 By demonstrating significant augmentation of cellular immunity and     adequate induction of a protective level of antiHBs (>10 mIU/ml) in HBsAg and HBeAg-positive     subjects 10 years after HB vaccination, we also proved that protection afforded by HB     vaccination persisted for no less than 10 years in all vaccinees.R Nevertheless, the     protective efficacy after the period of 10 years remains unknown. Knowledge of the duration     of protection of HB vaccine and the optimal timing of booster vaccination remains crucial. In     this study, we are going to examine the humoral and cellular immunity and monitored the     antibody response following a booster dose of HB vaccine in a group of children whom had been     vaccinated 14 years prior to this study.   "
178823|NCT00182845|"     The purpose of this study is to evaluate the feasibility of using Donepezil to prevent     post-operative cognitive decline (POCD) among individuals aged 65 and older who have a     baseline mild cognitive impairment (MCI) and are undergoing elective hip or knee replacement.   "
178685|NCT00180856|"     Radiofrequency ablation has achieved impressive results in the treatment of unresectable     primary and metastatic liver cancer. Animal studies have demonstrated that radiofrequency can     fully ablate lung tumors in animal models. We set up a prospective study to evaluate the     local efficacy of radiofrequency ablation of lung neoplasms. The aim of the study is to     prospectively evaluate local efficacy with a minimal follow-up of one year, tolerance, lung     disease-free survival and survival after radiofrequency ablation of lung tumors (primary lung     cancer or lung metastases).   "
178529|NCT00172341|"     Asthma, the airway inflammatory disorder, is an important chronic disease in children. About     10~15% children are bothered with this. Allergens, such as house-dust mites (HDM), animal     dander (i.e. cats and dogs), and seasonal pollens, are often implicated as causative and     triggering factors of respiratory attacks in children with asthma. Among them, mites are the     most common indoor allergen associated with asthma worldwide.      It appears that SLIT is somewhat effective and safe. However, on the current evidence,     further studies are needed to define the indications, the duration of treatment and     therapeutic optimal dose of standardized allergen extracts in relation to efficacy and side     effects before it is recommended for routine clinical use. The objective of the present study     was to investigate the effects and safety of StaloralTM, the standardized extracts of D. pt.     and D. f., in asthmatic children allergic to HDM.   "
178530|NCT00172354|"     Out-of-hospital cardiac arrest (OHCA) is an important issue for the emergency physicians and     co-workers. How to improve the return of spontaneous circulation (ROSC) rate and prognosis of     these patients challenges the emergency team. When encounters stress, the hypothalamus of     human releases corticotropin releasing hormone, which in turn stimulates the pituitary gland     to release ACTH. Then ACTH acts on the adrenal gland to release glucocorticoid to against     stress. Foley PJ et al found the dogs with bilateral adrenalectomy had lower ROSC rate during     resuscitation than those without surgery[1]. Karl H. Linder et al showed OHCA patients had     high serum vasopressin and ACTH level but low serum cortisol level. Besides, the serum     cortisol level had a negative correlation with collapse duration (no CPR duration)[2].     Studies also revealed the successfully resuscitated patients had higher serum ACTH and     cortisol level than non-resuscitated ones[2,3]. In addition, the serum cortisol level was     found to be correlated with short term survival rate and hemodynamic status in resuscitated     OHCA patients[3]. Animal study also showed mice receiving higher dosage of hydrocortisone had     higher ROSC rate and lower epinephrine requirement than those receiving lower dosage of     hydrocortisone or normal saline.      <Reference>        1. Foley PJ, Tacker WA, Wortsman J, Frank S, Cryer PE.; Plasma catecholamine and serum          cortisol responses to experimental cardiac arrest in dogs.Am J Physiol 1987;253:E283-9        2. Lindner KH, Strohmenger HU, Ensinger H, Hetzel WD, Ahnefeld FW, Georgieff M.; Stress          hormone response during and after cardiopulmonary resuscitation.Anesthesiology          1992;77:662-8        3. Schultz CH, Rivers EP, Feldkamp CS, Goad EG, Smithline HA, Martin GB, Fath JJ, Wortsman          J, Nowak RM.;A characterization of hypothalamic-pituitary-adrenal axis function during          and after human cardiac arrest.Crit Care Med 1993;21:1339-47        4. Smithline H, Rivers E, Appleton T, Nowak R.;Corticosteroid supplementation during          cardiac arrest in rats.Resuscitation 1993;25:257-64   "
178531|NCT00172367|"     Primary Objective: To study if lycopene can improve the biomarker status of urothelial cells     in patients with uremia-associated urothelial carcinoma.      Secondary Objective: To evaluate the general safety and tolerability of oral lycopene 30 mg     per day for 12 weeks in uremic patients.   "
178532|NCT00172380|"     To assess the overall response rate to docetaxel plus CDDP as neoadjuvant chemotherapy prior     to surgery, followed by adjuvant docetaxel plus CDDP in chemonaive patients NSCLC Stage IIIa     and IIIb.   "
178533|NCT00172393|"     Our study involved 142 children with EV71 CNS infections that included 61 (43%) with viral     meningitis, 53 (37%) with severe CNS involvement including encephalitis, polio-like syndrome     and encephalomyelitis, and 28 (20%) with cardiopulmonary failure after CNS involvement. These     children were subjected to physical and neurological examinations 2.85 (range 1.0-7.39) years     after disease onset. Those below the age of 6 years took the Denver developmental screening     test, while those 4 years and over took the intelligence quotient (IQ) test.   "
178534|NCT00172406|"     In the present study, we assessed the relation between diastolic dysfunction and myocardial     fibrosis in hypertensive patients without diabetes mellitus. A total of 20 medically treated     ambulatory non-diabetic hypertensive patients with normal left ventricular (LV) systolic     function were enrolled into this study. Myocardial fibrosis was evaluated by serum     concentrations of amino-terminal propeptides of type I and III procollagen (PINP and PIIINP).     All patients underwent examinations of diastolic function by echocardiography and     technetium-99m (99mTc) radionuclide ventriculography. There were 8 patients with PINP ≦53     μg/l (group 1) and 12 patients with PINP >53 μg/l (group 2). Patients in group 2 had     significantly lower LV peak filling rate (PFR; 3.2 ± 0.3 vs. 2.5 ± 0.2 end-diastolic     volume/s) and shorter time to PFR ( 257 ± 41 vs. 174 ± 22 ms). Besides, the group 2 patients     also had lower right ventricle PFR (1.9 ± 0.2 vs. 1.5 ± 0.1 end-diastolic volume/s) and     shorter time to PFR ( 221 ± 29 vs. 154 ± 29 ms). Echocardiographic parameters for LV     diastolic dysfunction (E/A ratio of mitral flow, deceleration time of E flow, velocities of     pulmonary venous flow [retrograde A wave, systolic /diastolic velocity ratio], isovolumetric     relaxation time, Tei index) were all comparable between two groups. In multiple regression     analysis, LV time to peak filling rate was the only parameter that independently predicted     serum PINP level (p<0.05). In conclusion, elevated serum PINP level reflected LV diastolic     dysfunction in hypertensive patients without diabetes.   "
178535|NCT00172419|"     Inflammation is important in the both pathogenesis and outcome of atherosclerosis. Plaques     containing numerous inflammatory cells, particular macrophages, have a high risk of     rupture.We hypothesize that statin-induced plaque regression could be monitored clinically by     use of FDG PET/CT approach, and can be detected noninvasively earlier than previously     reported.   "
178536|NCT00172432|"     Background: Myocardial fibrosis is a major component in cardiac remodeling in patients with     myocardial infarction or hibernation. However, the association of cardiac fibrosis and     coronary artery disease (CAD) in patients without infarction or hibernation is still unclear.     In the present study, we analyzed the relationship between serum concentrations of     procollagen propeptides and severity of CAD in such patients. Patients and methods: Forty-six     patients (32 men and 14 woman; mean age 64 years) with chest pain and normal left ventricular     contractility were enrolled into this study. Myocardial infarction was excluded by history     and electrocardiograms. All patients received stress thallium-201 single photon emission     computed tomography (SPECT) and analysis of the serum levels of the aminoterminal propeptide     of type I and III procollagen (PINP and PIIINP).   "
178552|NCT00172640|"     Hepatocellular carcinoma (HCC) is one the most common malignancies in the world, especially     in sub-Saharan Africa and Southeast Asia. Since 1984, it has been the leading cause of cancer     death in Taiwan. About 6000-8000 people died of this cancer every year in Taiwan. DNA     microarray (DNA chip) is a very powerful tool to clarify the genetic changes in cancers.     Expression profiling techniques have been used to simultaneously monitor the expression of     thousands of genes from human tumor samples. It has been successfully used to predict     clinical outcome and survival as well as classify different types of cancer. In this study,     we will use the DNA chip to study the genetics in liver cancer patients.   "
178843|NCT00183118|"     The purpose of this study is to test an HIV prevention intervention in a Russian substance     abuse treatment facility using a randomized trial study design.   "
178537|NCT00172445|"     Kikuchi-Fujimoto disease is a distinctive syndrome of necrotizing lymphadenitis which was     formally described in 1972 by two Japanese pathologists, Kikuchi and Fujimoto. It is a     benign, self-limited disease that predominantly occurs in young women. It was more common in     Asian people, especially in Japanese. The most frequent clinical presentations are fever     (30~50%) and cervical lymphadenopathy, often tender in palpable. Other lymph node regions can     be affected, and hepatosplenomegaly may be present. The laboratory findings include     leucopenia with atypical lymphocytosis. ESR, transaminases and lactate dehydrogenase are     often raised. The clinical features are easily confused with other conditions, particularly     lymphoma. Therefore the diagnosis depends on the pathological findings. The typical findings     are paracortical lesions consisting of patchy zones of eosinophilic fibrinoid necrosis and     abundant karyorrhexis. In general, spontaneous resolution of symptoms and signs within a few     months can be expected without treatment.For decades, the etiology of Kikuchi's disease has     been speculated. Although the perforin and Fas pathways of cytotoxic T cells induce an     abundance of apoptosis and thus induce necrotizing lesions, the trigger factor is unknown.     Since the disease can precede or occur in association with a connective tissue disorder,     especially SLE, the autoimmune contribution to the etiology has also been speculated.     However, the clinical course of Kikuchi's disease, often sudden onset and spontaneous     resolution, the frequent flu-like or upper respiratory prodrome, and the prominence of     cervical lymphadenopathy, support a viral cause. Evidence for a viral cause also includes     peripheral blood atypical lymphocytosis and elevated serum IFN-a or 2`-5` oligoadenylate     synthetase levels. Several infectious agents have been suggested, including bacteria (e.g.     Brucella, Yersinia), parasites (e.g. toxoplasmosis) and viruses (e.g. EBV, CMV, HHV6, HHV8,     parvovirus B19, HTLV, HIV).The aim of this study is to collect cases of Kikuchi' disease in     bureau of NHI and NTUH. We will analyze the incidence rate, age of onset, sex, season of     onset and clinical course to see if there is any clustered cases, or nosocomial infection.     Then we will study the etiology of Kikuchi's disease especially the infection causes by     analyzing pathologic specimen and serology. We hope to find out the etiology of Kikuchi's     disease and the new treatment.   "
178538|NCT00172458|"     Vertebral artery stenosis (VAS) decreases posterior brain perfusion, causing vertebrobasilar     insufficiency (VBI). It is also an important embolic source to the posterior brain. The most     frequently involved location is the proximal part of the vessel, including the ostium.     Various surgical procedures have been described for the treatment of proximal VAS with     symptoms refractory to medical therapy, but all are technically difficult with high operative     mortality and morbidity.      Endovascular intervention has been described as an alternative to surgery. Balloon     angioplasty is limited by elastic recoil and dissection. The restenosis rates reported in the     literature varied, as high as 75 %. Stenting offers salvage following unsuccessful balloon     angioplasty, and primary stenting have been shown to be safe and effective with lower     restenosis rate. Coronary equipments are ideal for ostial VAS, considering the size of the     artery and location of the lesion. Recently, Albuquerque et al. reports a relative high     restenosis rate in a longer follow-up duration. Restenosis seems to become an important issue     regarding the patients’ quality of life. However, there is no clinical parameter to predict     restenosis of VAS. The purpose of this study is to evaluate the clinical results of our     series of symptomatic ostial VAS treated exclusively with tubular balloon expandable coronary     stents. We sought to identify predictors of restenosis.      This is a clinical observation study. Only chart review and angiographic review will be     performed.   "
178539|NCT00172471|"     Sleep disorders are common in patients with end-stage renal disease on both hemodialysis and     peritoneal dialysis and are associated with significant medical, psychological and social     disturbances. Numerous factors have been suggested as contributing to or associated with the     high prevalence of sleep disturbance in this population.      Increasing evidence suggests that cytokines are involved in the regulation of sleep and     wakefulness and that the communication between the sleep and the immune system is     bi-directional. Blood-dialyzer or peritoneum-dialysate interaction during dialysis therapy     has the potential to activate mononuclear cells leading to production of inflammatory     cytokines. These cytokines are believed to play a significant role in dialysis-associated     morbidity and mortality. Nevertheless, a cytokine overproduction may alter sleep pattern in     chronic dialyzed patients, thus explaining the presence of sleep disorders in these patients.     In the other way, sleep loss may have effects on immune process and secretion of cytokines in     chronic dialyzed patients. The purpose of this study was to examine the relationship between     quality of sleep and serum cytokine levels in hemodialysis and peritoneal dialysis patients.   "
178540|NCT00172484|"     The Northern Taiwan Stroke Center for Prevention and Treatment Project is a single medical     center, 3-year, multipurpose study. The aims of this study are (1) to set up a     multidisciplinary stroke team in a well-designed stroke center for stroke care; (2) to     establish a systemic stroke prevention / education protocol based on people's awareness of     stroke; and (3) to create a better stroke rehabilitation protocol and pathway.there are three     components in rehabilitation projects. First, we want to identify potential factors related     to functional outcome in patients with stroke before and after stroke center. Second, we want     to compare the functional outcome in patients who admit to the stroke center as to those     admitted to the general ward. Third, we want to investigate the effect of electrical     stimulation on upper limb function in patient with acute stroke.   "
178541|NCT00172497|"     The purpose of this series of study has a many-fold intention depicted as follows: to     describe and characterize schizophrenic patients' aggressive acts in hospital and community,     to identify and specify heterogeneity in their structure, and to look for and set up risk     factors for prevention. This study investigates four major issues: (1) Establishing an     objective behavior rating scale for measuring aggressive acts; (2) Understanding the     characteristics and incidence of aggressive acts by patients with schizophrenia; (3)     Exploration of the heterogeneous structure of aggressive acts by patients with schizophrenia;     and (4) Identifying the risk factors of aggressive acts of patients with schizophrenia.   "
178542|NCT00172510|"     To elucidate the molecular pathology of the 4 families with 17α-hydroxylase/17,20-lyase     deficiency.   "
178543|NCT00172523|"     The purpose of this study is to elucidate the significance of adipocytokine in women with     PCOS among adiposity, hyperandrogenism and insulin resistance.   "
178544|NCT00172536|"     The purpose of this study is to investigate the changes of cardiorespiratory fitness and left     ventricular function in type 2 diabetes after uncomplicated coronary artery bypass graft     (CABG) surgery.      We hypothesize that exercise capacity, left ventricular diastolic function, and biochemical     data improves after 12-wk exercise training in patients with type 2 diabetes underwent CABG.   "
178603|NCT00173303|"     The purpose of this study is to evalute whether CAD (computer-aided detection) in FFDM     (full-field digital mammography) can facilitate the detection rate of breast cancer on     mammography compared with FFDM without CAD.   "
178604|NCT00173316|"     The role of vascular endothelial growth factor-C (VEGF-C) and its receptors induced     lymphangiogenesis and host inflammatory responses on the carcinogenesis of oral cancers and     premalignant lesions   "
178545|NCT00172549|"     The purpose of this study was to explore the quality of life and its related factors of     patients with major depressive disorder. This study adopted cross-sectional research design.     Purposive sampling was used to collect data from 120 patients came from the psychiatric     outpatient departments of a medical center and a psychiatric hospital in northern Taiwan.     Data were collected through structured questionnaires, which included：(1) demographic data     sheet, (2) 5-item Brief Symptom Rating Scale (BSRS-5), (3) the Center For Epidemiologic     Studies Depression Scale(CES-D), (4) Inventory of Socially Supportive Behaviors(ISSB), (5)     World Health Organization’s Questionnaire on Quality of Life：BREF-Taiwan Version     100(WHOQOL-BREF). Data were analyzed by using SPSS/Windows 10.0 statistical software. The     descriptive statistics methods included frequency distribution, arithmetic mean, standard     deviation, and percentage. Data were analyzed by using independent t-test, Pearson’s     product-moment correlation, one way ANOVA and stepwise multiple regression and so on, with     which we can examine the demographic, degree of depression, social support and their links to     the quality of life. Through the research, we found out the following results：      1.The condition of major depressive disorder patients’ quality of life is score range of each     subtitle from 4-20. A sum from the following subtitles：physical domain is 11.54,     psychological domain is 10.46, social domain is 11.61 and environmental domain is 12.82. The     quality of life results is higher of environmental domain, which is poorer of psychological     domain.      2. The results of quality of life related to demographic, degree of depression, social     support were as followed：        1. Physical domain：the independent variables of significant linear correlation is age, the          age of early-onset, type of occupation, living arrangements, economic status, health          status, the degree of depression and emotional support.        2. Psychological domain：the independent variables of significant linear correlation is age,          the age of early-onset, type of occupation, living arrangements, economic status, health          status, the degree of depression, the sum of social support, emotional support,          instrumental support, informational and appraisal support.        3. Social domain：the independent variables of significant linear correlation is age, the          age of early-onset, marital status, type of occupation, economic status, health status,          the degree of depression, the sum of social support, emotional support, instrumental          support, informational and appraisal support.        4. Environmental domain：the independent variables of significant linear correlation is age,          the age of early-onset, marital status, economic status, the degree of depression, the          sum of social support and emotional support.      3.The best stepwise regression models of predicting major depressive disorder patients’     quality of life were as followed：        1. Physical domain：the best predicting factor is the degree of depression, and accounted          for explained 60.30﹪of the variance.        2. Psychological domain：the best predicting factors are the degree of depression, the sum          of social support, the age of early-onset, age more than 71 years old, and accounted for          explained 76.50﹪of the variance.        3. Social domain：the best predicting factors are the degree of depression, the age of          early-onset, informational and appraisal support, unemployment and age more than 71          years old, and accounted for explained 53.80﹪of the variance.        4. Environmental domain：the best predicting factors are the degree of depression, income          less than one hundred thousand, income more than one hundred ten thousand and more than          71 years old, and accounted for explained 53.50﹪of the variance.      The results of this study could understand major depressive disorder patients’ quality of     life condition and provide related research in the future, develop local data and health     administration reference of foundation.   "
178546|NCT00172562|"     In malignant or neoplastic disease, angiogenesis is defined as the generation of new     capillaries from preexisting blood vessels, e.g. by sprouting or by intusseption. Through the     pioneering work of Folkman, it was recognized that angiogenesis plays an important role in     tumor development, progression, and metastasis. It is also conceivable that there are forms     or developmental stages of leukemia, multiple myeloma, or lymphomas that will progress     independently of angiogenesis. Synthesis of angiogenesis activators, such as vascular     endothelial growth factor (VEGF) and other angiogenic factors, such as basic fibroblast     growth factor (bFGF), has been demonstrated for leukemia cells, non-Hodgkin’s lymphoma, and     myeloma cells. Microvessel density is also significantly elevated over normal controls with     progressive increases according to the stages of myelodysplastic syndrome. Increased     microvessel density (MVD) in the bone marrow was found in patients with multiple myeloma in     comparison to normal controls and increased MVD is an adverse prognostic marker in multiple     myeloma. However, the functional status of the blood vessel (e.g. permeability) cannot be     determined by the above mentioned methods.   "
178547|NCT00172575|"     The purpose of our study is to determine whether contrast-enhanced dynamic MRI (DCE MRI)     analysis of tumor angiogenesis and perfusion can be used as a reliable modality to     differentiate benign from malignant solitary pulmonary nodules (SPN) before surgical     intervention, using kinetic model derived from DCE MRI, and further correlate if there is any     positive correlation between angiogenesis factor (vascular endothelial growth factor VEGF,     microvessel density MVD); and if the perfusion parameters from DCE MRI can predict patients’     outcomes and survival.   "
178548|NCT00172588|"     Our previous results revealed that the expression of killer inhibitory receptors (KIRs) on NK     cells was decreased in eutopic endometrium in women with adenomyosis. It implies that the     formation of adenomyosis might be due to abnormal endometrial tissues, but not the aberrant     local immunological dysfunction in myometrium. In addition, in vitro coculture of macrophages     and endometrial stromal cells (ESC) increase the expression of IL-6 mRNA in ESC, which might     further enhance the proliferation of ESC and subsequently result in the formation of ectopic     endometrial implants in adenomyosis. Besides, another possible mechanism is the abnormal     apoptosis of ESC in adenomyosis. In endometriosis, apoptotic endometrial cells were found to     be decreased, which possibly accounts for the formation of endometriosis. However, there have     not been reports investigating the apoptosis of ESC in adenomyosis.      In this study, we try to investigate apoptotic ESC with flow cytometry in women with and     without adenomyosis. Annexin V, bcl-2, and caspase-3 were measured to represent the degree of     apoptosis in ESC.   "
178549|NCT00172601|"     Background: Frozen shoulder syndrome (FSS) or adhesive capsulitits, a condition of uncertain     etiology characterized by a progressive loss of both active and passive shoulder motion, is     one of the most common musculoskeletal disorders encountered in daily orthopaedic practice     and remains challenging to treat. To regain the normal extensibility of shoulder capsule and     tight muscular tissues, passive stretching of the shoulder capsule by means of mobilization     techniques has been recommended, but limited data for supporting the use of these treatments     are available. Due to the performance of techniques (mid-range/end-range mobilizations     combined with or without interscalene brachial plexus block), a lack of objective and     subjective outcome criteria, an inappropriate research design (case report and clinical trial     without control), and utilization of other treatment modalities (home exercises and hot/cold     packs), it is not possible to draw firm conclusions about the efficacy of mobilization in     patients with FSS. Objective: The aim of our study is to investigate the effect of     mobilization treatment and to determine whether a difference of treatment efficacy exists     among three mobilization techniques (mid-range mobilization, end-range mobilization, and     mobilization with movement) in patients with FSS. Design: We will carry out a crossover     multiple-treatment trial on two groups. In group one, an A-B-A-C (A: mid-range mobilization,     B: end-range mobilization, C: mobilization with movement) multiple-treatment design will be     used. In group two, an A-C-A-B multiple-treatment design will be used. There will be three     weeks of each phase. An independent trained outcome assessor, blinded to treatment     allocation, will evaluate the participates at baseline and at 3-week intervals for 12 weeks.     Outcome assessment include pain perception, disability assessment, and Shoulder complex     kinematics and associated muscular activity. Analysis of covariance (ANCOVA) will be     undertaken using the follow up data at 3, 6, 9 and 12 weeks for each of the outcomes, with     adjustment for the baseline values of the outcome of interest. Independent t-Tests will be     conducted to compare change of outcome variables between two groups (A-B in one group vs. A-C     in the other group, A-C in one group vs. A-B in the other group).   "
178550|NCT00172614|"     Insulin resistance and disturbances in energy homeostasis are associated with body weight     changes, such as diabetes, hypertension, hyperlipidemia, obesity, cancer cachexia, aging, and     acute or chronic infectious diseases. Cytokines secreted by adipose tissue and inflammatory     cells play important roles in the pathological conditions. Several novel cytokines were     disclosed recently, but their functions have not been well known. Further investigation of     these cytokines, resulting in insulin resistance and energy homeostasis, is very important to     elucidate the mechanisms and develop new therapeutic strategies.   "
178551|NCT00172627|"     Evidence is rapidly accumulating that chronic inflammation may contribute to carcinogenesis     through multiple mechanisms in a number of malignancies, including gastric carcinoma (GC).     Cyclooxygenase-2 (COX-2), an inducible enzyme pivotal in the inflammatory response, converts     arachidonic acid to the prostaglandins (PGs) required in initiating and maintaining reactions     during the inflammatory process. Over-expression of COX-2 has been reported in a wide variety     of cancers and is therefore implicated to play an important role in carcinogenesis. COX-2 can     be blocked by non-steroidal anti-inflammatory drugs (NSIADs) and is currently the most     studied therapeutic target of NSAIDs. Clinically, NSAIDs have long been used to treat various     inflammatory or rheumatologic disorders.      Earlier clinical studies have confirmed an association between COX-2 over-expression and GC     occurrence. The known mechanisms by which COX-2 promotes carcinogenesis include evasion from     apoptosis, suppression of immunity, promotion of angiogenesis, and facilitation of     invasiveness. However, inflammation-associated factors mediating the effects of COX-2 on     carcinogenesis remain largely unknown. Interleukin-6 (IL-6) is a pro-inflammatory cytokine     associated with gastritis and GC. Our earlier works has disclosed that IL-6 can promote     angiogenic and anti-apoptotic ability of GC. However, the relationship between COX-2 and IL-6     in GC remains unknown.      The present study aims to investigate the clinical association between COX-2 and IL-6 in GC,     to use a GC cell model for experimental study on causation and mechanism, and to verify the     in vivo effect of COX-2 on IL-6 by an animal model.      We will collect 100 consecutive surgical samples of GC from the pathology archive of National     Taiwan University Hospital and use immunohistochemical stain to compare protein expression in     GC. The clinical study is to define certain subgroups of GC exhibiting an association between     COX-2 and IL-6. In experimental study, we will clarify the causal relationship by the dose-     and time-dependent experiments of COX-2 transient transfection in a GC cell line. COX-2 acts     mainly via PGs, like PGE2. Therefore, we also stimulate GC cells with exogenous stimulation     of PGE2 and EP receptor 1-4 agonists to determine the possible way(s) by which COX-2 induces     IL-6 expression. A selective COX-2 inhibitor NS-398 and various inhibitors of PGE2 receptors     are used as well to block COX-2 for determining the signaling pathway of COX-2 on IL-6.     Finally, we will establish a stable COX-2 over-expressing transfectant of GC cells and its     control vector transfectant for xenograft implantation study on mice. A COX-2 selective     agent, celecoxib, will be administered orally to mice and tumor blocks will be harvested for     determination of IL-6 expression.      The present study will provide clearer understanding of the role of COX-2 on the     pro-inflammatory cytokine IL-6 in GC in both clinical and basic aspects. It might also stand     for a model capable of systemically investigating the role of COX-2 on various cytokines     implicated in GC.   "
178754|NCT00181935|"     The objectives of this study are to study the safety, effectiveness, tolerability and dosing     regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and     Bipolar II Disorder in preschool children over an 8 week period. We hypothesize that these     atypical neuroleptics may be effective in treating pediatric mania, with a lower risk of     extrapyramidal side effects.   "
178553|NCT00172653|"     Background:      Shoulder-related dysfunction (SD) is a common health problem in various patient populations.     SD can affect an individual's ability to function independently, consequently decreasing     quality of life. A battery of simple measurable function-related tests for patients with SD     is important.      Objective:      The purpose of this study is to test the reliability, validity, and potential clinical use of     a battery of function-related tests in patients with SD. Additionally, the biomechanical     characteristics of the battery of function-related tests will be analyzed in terms of     three-dimensional shoulder complex movements and associated muscular activities.      Design:      Repeated measurements and descriptive study      Methods:      The affected arms of 60 symptomatic patients with SD will be assessed by two clinicians as     well as by one clinician twice to calculate intertester and intrarater reliabilities.     Assessment will include self-report measures and the battery of function-related tests     (hand-in-neck, hand-to-scapula, hand-to-opposite-scapula, and modified Kibler's lateral     scapular slide test). Pearson correlation or Spearman's rho correlation coefficients will be     calculated and the correlation matrices will be examined for evidence of convergent and     discriminative validity among pain, disability, and function-related measures in patients     with SD. Principle axis factor analysis will be performed on the kinematic measurements and     muscular electromyography (EMG) activities to characterize the factor loading of each task.   "
178554|NCT00172666|"     Although SLE and RA are correlated with genetic predisposing factors such as human leukocyte     antigen (HLA) class II, both diseases and other genetic factors might have contributed to the     development of dysregulated lymphocyte activation and autoimmunity.      Decoy receptor 3 (DcR3)/TR6 is a secreted protein belonging to the tumor necrosis factor     (TNF) receptor family. It binds to Fas ligand (FasL), LIGHT, and TL1A that are all TNF family     members. It was noted that soluble or solid phase DcR3-Fc co-stimulated proliferation,     lymphokine production and cytotoxicity of mouse and human T cells upon T-cell receptor (TCR)     ligation. Recently, the investigators found that the serum level of soluble DcR3 was higher     in SLE patients than in healthy control subjects (unpublished data). Taken together, the     investigators propose that in autoimmune diseases, such as RA and SLE, activated T cells     secrete more DcR3 than non-autoimmune controls, which may, in turn, costimulate T cells     further and cause dysregulated lymphocyte activation. With the aim to establish the possible     correlation between DcR3 genetic polymorphisms, DcR3 expressions, and autoimmune phenotypes,     the investigators offer this proposal. They plan to investigate the single nucleotide     polymorphisms (SNPs) in the DcR3 gene. The genetic polymorphisms on the DcR3/TR6 gene and     circulating DcR3 level will be compared between RA, SLE and non-autoimmune control subjects.   "
178555|NCT00172679|"     Tai Chi is a traditional Chinese martial art that has been practiced for many centuries.     Improvements in cardiorespiratory function, balance, muscular strength, flexibility in older     subjects; preventing falls in the frail elderly; stress reduction, and mood state with Tai     Chi practices have been well established. A potential immune response effect of Tai Chi     practice is a frequent claim; however, this is an under-researched area. Therefore, in this     study, the researchers will examine the effects of Tai Chi on innate and adaptive immune     function.   "
178556|NCT00172692|"     Soft food chewing does not require strong bite force. The number of chewing strokes and     occlusal surface area of the posterior teeth are more important. Clinically, reduction of     occlusal surface to protect the abutments of a fixed or removable partial denture or the     implant supported teeth is often necessary. If a certain chewing ability is maintained with     reduced occlusal area, changing chewing velocity might help. For this hypothesis, the effect     of chewing velocity on soft food chewing ability would be observed first. The purpose of this     study is to evaluate the deliberately changed chewing gum chewing velocity on the chewing     ability of healthy subjects whose dental occlusal surface area is known. Twenty dental     students (10 men and 10 women with an age range of 20-30 years) with healthy masticatory     systems and complete dentition will be asked to chew HA containing chewing gum with habitual     side teeth at the cycle time of 0.5 sec, 1.0 sec and 1.5 sec for 30, 40, and 50 times. Jaw     movement, tooth contact, and muscle activities will be observed during chewing gum chewing.     The distribution of HA particles in the gum bolus after each chewing session will be measured     and regarded as the chewing efficiency of that subject. Occlusal surface area of the     maxillary posterior teeth, chewing rate, chewing time, muscle activity and jaw lateral     displacement will be related to the chewing efficiency with multiple regression analysis. The     effects of practice due to changing of chewing rate will also be evaluated.   "
178557|NCT00172705|"     This study is proposed to explore the correlation between fatty content of fatty liver and     the difference of CT attenuation value in men using dual-energy CT, and to set up a threshold     for diagnosis of fatty liver.   "
178558|NCT00172718|"     Osseointegrated root form implants have been applied successfully in treating fully and     partially edentulous patients and patients with single tooth missing. However, the success     rate of osseointegrated dental implants was not as good in patients with poor bone quality.     The reasons are believed that poor bone quality reduces the initial stability of dental     implants and then reduces the success rate. For increasing initial stability of dental     implants, some technical modifications are suggested in literature. However, due to lack of     an objective method to evaluate bone quality, they are controversial. The purposes of this     clinical study are to develop a standard procedure which using cutting resistance measured by     Osseocare in surgery to evaluate the bone quality and to compare with the clinical     experiences of oral surgeons. The objective outcome, initial stability of dental implant, is     measured with Osstell. The analyzed results are also helpful for less experienced surgeons.   "
178652|NCT00179595|"     The purposes of this study are:        1. To examine molecular and biochemical changes, associated with the relaxation response          (RR) that can counteract the effects of stress in healthy adults.        2. To compare genomic, molecular and biochemical parameters between healthy adults with a          long term meditative practice and those with no experience in meditation.      Since stress is a factor in the development of many health conditions, a further     understanding of the mechanisms of the RR should be developed. The project is designed to     determine how the RR can improve the quality of life that has been adversely affected by     stress.   "
178894|NCT00171288|"     The objective of this study is to assess the effect of the combination treatment on     C-reactive protein and inflammatory markers as well as the safety and tolerability in a     Spanish population   "
178559|NCT00172731|"     The purpose of the study is to develop a questionnaire on community occupational     participation for persons with schizophrenia living in the community. In the International     Classification of Functioning, Disability, and Health (ICF) recently revised by World Health     Organization, activity participation is recognized as an important indication of     health-related status. From the perspective of occupational therapy, the researcher intends     to investigate the experiences of occupational participation among schizophrenic patients     living in the community, and to develop a measuring tool for occupational participation     accordingly.      The development of the Community Occupational Participation Questionnaire will be based on     the result of a qualitative research project which the researcher is carrying out at the     moment. The resultant questionnaire will provide a quantitative measure of community     occupational participation for persons with schizophrenia, as well as a measurement tool of     activity participation for health-related research studies. Furthermore, it may provide     valuable information to the development of community psychiatric services.      This current study will take one year. Tasks to be accomplished include: building item pool,     examining content validity of each item, pilot testing, item analysis, norm establishment,     and testing reliability and validity. Data will be collected in different areas of Taiwan,     and will be analyzed with the following methods: content validity ratio, item-total     correlation, Cronbach’s alpha, and confirmatory factor analysis. The study will result in an     occupational participation questionnaire with norm, validity and reliability.   "
178560|NCT00172744|"     The purpose of this study is to observe cyclic tensional force on the osteogenic     differentiation of human periodontal ligament stem cells.   "
178561|NCT00172757|"     We will explore the genetic (including APC, k-ras, p53, MSI, etc.) and environmental     (including family history, life style, diet, nutritional status, DM, serum IGF-I, IGFBP-3,     etc.) risk factors of colorectal tumorigenesis. We will accrue approximately 1000 patients as     experimental group. The control group consists of 2000 individuals who were confirmed without     colorectal cancer or polyps by colonoscopy. We estimated the statistical power of this study     will reach more than 90%. In the second year, we will explore the association between various     environmental risk factors with the epigenetic changes of various oncogenes and tumor     suppressor genes. Firstly, we will study the correlation between hypermethylation of promoter     region of hMLH1 gene with various environmental factors. Next, we will explore the genetic     polymorphisms of promoter of E-cadherin gene. Recently, it has been reported that the C→A     genetic polymorphism in the promoter region of E-cadherin gene in prostate cancer. Since this     phenomenon has not been reported in colorectal cancer, it is mandatory for us to extend our     research to the E-cadherin polymorphisms of colorectal cancer. Moreover, this project will     focus on exploration of the association between the genetic polymorphisms of promoter of TS     gene with chemosensitivity to 5-Fu-based therapy. We speculated that the better prognosis in     colorectal tumors with MSI is related to their expression of TS gene. In summary, the second     year of this project will extend our accumulated experience in the study of genetic     polymorphisms to further clarify the association between genetic polymorphisms of TS gene     with the prognosis of colorectal cancers after chemotherapy. We believe that this project     will facilitate: (1) the further clarification of colorectal cancer tumorigenesis; (2) the     establishment of domestic epidemiological data of colorectal cancer of Taiwan, and (3) the     improvement of the quality of clinical management of patients with colorectal cancer.   "
178562|NCT00172770|"     Schizophrenia is a severe mental illness, which has a prodromal phase of 1-2 years prior to     the onset of the illness. During the prodromal phase, patients might show maladaptation     and/or poor social functioning. However, these early symptom of schizophrenia might be     overlooked by patients and their families. At that period, patients might strive to improve     their social interactions and social functioning. However, the efforts might further create     their stress level on everyday life, which can actually accelerate the illness onset of     schizophrenia. In other words, the efforts would worsen the pathophysiologic changes in the     brain, which can result in the positive symptoms of schizophrenia.      Previous researches found that the critical period for treatment of schizophrenia is the     early phase of illness onset, especially the first two or three years. Delay treatment would     worsen the illness. To this extent, early treatment would bring to a better prognosis as well     as minimize the costs of individuals, families and society. In other words, early     interventions not only can prevent relapse, it also can benefit patients’ psychosocial     adjustments. However, researches found that the average duration of untreated psychosis is     25.2 months in Taiwan, which indicates the phenomena of delay treatment and this trend might     result in missing the critical treatment period.      This is a two years study aiming to establish an early intervention program for patients with     schizophrenia. In the first year, it aims to understand the phenomena of psychiatric care     services utilization for patients with schizophrenia, special emphasis will be on the delay     treatment and pluralistic health seeking process. In the second year, it aims to establish an     early intervention program. The results of this research would contribute to in-service     trainings, service providing, and policy making of psychiatric services.   "
178563|NCT00172783|"     To investigate the size of PPD and TB specific ELISPOT among children between 3m/o and 15 y/o     . Calculate the normal range of age specific PPD size in children who recieved BCG at     new-born period.   "
178564|NCT00172796|"     We, the investigators at National Taiwan University Hospital, want to compare patients' islet     cell function, insulin sensitivity and risk of chronic complications with normal subjects.     Moreover, we want to examine whether they are at a higher risk of having metabolic syndrome     and to answer whether we should screen the phenotypes of metabolic syndrome in impaired     fasting glucose (IFG) and impaired glucose tolerance (IGT) patients. Then, we want to examine     the association between insulin sensitivity and islet functions.   "
178565|NCT00172809|"     The treatment response with conventional interferon alpha alone in patients with end stage     renal disease and chronic hepatitis C is about 33-39%. However, the drop-out rate is     17-29.6%. Pegylated interferon alpha, a newly developed form of interferon with superior     pharmacokinetic profiles, has not been used to treatment these patients. We expect the better     treatment response treated with peginterferon alpha than conventional interferon. In     addition, we also observe the safety of the two drugs during the study. The goal of the study     is to compare the efficacy and safety of the two different treatment regimens in patients     with chronic hepatitis C and end stage renal disease.   "
178566|NCT00172822|"     prospective study to collect data of patients with appendicitis, not receiving operation   "
178567|NCT00172835|"     Among several markers of inflammation and sepsis, procalcitonin (PCT) markers is being     studied to investigate their accuracy for the diagnosis of bacterial infections. PCT is the     prehormone of calcitonin, which is normally secreted by the C cells of the thyroid in     response to hypercalcemia; under these normal conditions, negligible serumPCT concentrations     are detected. The mechanism proposed for PCT production after inflammation and its role are     still not completely known. It is believed that PCT is produced by the liver and peripheral     blood mononuclear cells, modulated by lipopolysaccharides and sepsis-related cytokines. It     binds to polysaccharides in pathogens, activating the classical complement pathway. The     reported diagnostic accuracy of PCT for the diagnosis of bacterial infections has varied     across studies.   "
178653|NCT00179608|"     This study will determine the MDT of intravenous DTIC when administered in combination with a     fixed dose of oral lenalidomide in subjects with metastatic malignant melanoma previously     untreated with systemic chemotherapy. This study will evaluate the safety and preliminary     efficacy of the combination of lenalidomide and DTIC. Subjects will be receive lenalidomide     for 14 consecutive days and DTIC on day one of each 21 day cycle.   "
184358|NCT00255489|"     The purpose of this study is to characterize the safety profile of ZD1839 in combination with     Palliative thoracic Radiotherapy in patients with non-small cell lung cancer   "
178568|NCT00172848|"     The purpose of this study was to discuss the relation of mastery, social support and     depression in patients with depressive disorder. Cross-sectional quantitive study and     purposive sampling method were designed. Data collection and analysis was conducted through     structural questionnaires (including demographics, social support scale, mastery scale, CESD     scale) at a medical center in Taipei. Results showed that patients with depression whose     degree of depression was negative correlated with mastery and social support, and mastery was     positive correlated with social support. Regression statistics results showed that mastery,     social support, age, loss of jobs can predict degree of depression up to 60 percent. The     mastery was strongest independent predictable factor to degree of depression, and had partial     or total mediate effects to age, loss of jobs, financial condition, and social support. The     result of this study suggested that clinically the care of patients with depression should     focus on their confidence in mastery and provide strategies to promote their confidence in     mastery, which can effectively reduce the degree of depression of those patients.   "
178569|NCT00172861|"     Background:      Gastric carcinoma (GC) remains among the most frequent malignancies in Taiwan as well as in     the world and also one of leading causes of cancer-related death. Accumulating evidence shows     that chronic inflammation leads to the occurrence of cancers, including GC, via multiple     mechanisms.      Cyclooxygenase-2 (COX-2) is a crucial enzyme in inflammatory process and is shown to be     up-regulated in a variety of cancers. Therefore, COX-2 may play an important role in     carcinogenesis. The hallmarks of cancer include continuing proliferation, evading apoptosis,     prohibiting immunity, promoting angiogenesis, enhancing invasion and metastasis. We     hypothesize that COX-2 induces carcinogenesis through multiple mechanistic strategies and     interactions of multiple genes simultaneously.      Laser capture microdissection (LCM) for obtaining pure cancer cells and microarray technology     and analysis are now generally accepted as powerful tools in genomic research, providing     reliable microdissection of cancer cells and simultaneous analysis of whole genome.      Aim:      Use microarray technology to investigate patterns of genomic change related to differential     COX-2 expression and their clinicopathological association in GC.      Materials:      GC cell lines are transfected with COX-2-expressing vector to establish cell lines with     differential levels of COX-2 expression. Clinical specimens are obtained from surgical     resection of GC proved by pathology at the Surgical Department of National Taiwan University     Hospital, which COX-2 expression is evaluated by Western blotting and immunohistochemical     staining.      Methods:      The present project will use microarray for analysis of genome clustering patterns of     surgical tissue (GC cells procured by LCM) and GC cell lines based on differential COX-2     expression levels, to discover significantly positively or negatively associated gene     clusterings which contain candidate genes for studies of carcinogenesis mechanisms and     establishment of animal experiment models in another component project.      Execution:      In the first year of this 3-year project, we will establish GC cell lines expressing     differential COX-2 levels by transfection of COX-2-expressing vector and focus on analyzing     their genomes by microarray. We also start to collect surgical specimens of GC, record     clinicopathological characteristics, procure cells by LCM and assess RNA quality, perform     microarray experiments. In the second year, we will continue LCM, RNA extraction, and     microarray experiments. In the third year, microarray experiment of a total of 60 pairs,     including 30 high-COX-2 cases and 30 low-COX-2 cases, of tumor and non-tumoral tissues are     completed. Final analysis is carried out to identify clustering, to select candidate genes,     and investigate their relationship to clinicopathological characteristics, according to COX-2     expression. These genes are to be subjected to mechanism and animal studies. We expect a     better understanding of patterns of gene clustering in differential COX-2 gene expression.   "
178570|NCT00172874|"     The aim of the study is to understand the clinical characteristics of Taiwanese eating     disorders as well as establishment of the psychometric properties of eating disorder-related     questionnaires (EDI and BITE).   "
178571|NCT00172887|"     The quantity and quality of inpatient services for persons with psychiatric illness have been     enhanced in the last two decades. Following the enforcement of nationwide health insurance     and the Physically and Mentally Disabled Citizens Protection Act, the financial pressure of     medical care for psychiatric patients is relieved, and actions related to the protection of     patients' human rights have been taken. Nonetheless, problems related to psychiatric illness     are not limited to symptoms. Patients' daily functions are affected and it causes continuous     pressure on the family. Currently, psychiatric care places more emphasis on inpatient     services. Once the patient is discharged from the hospital, related psychiatric services are     not widely available, which leads to symptom exacerbation, repeated hospital admissions,     increased burden to the family, etc. A provision of continuous long-term care that meets the     various needs of psychiatric patients is a critical issue in current psychiatric care.      Based on a three-phase needs assessment model, the purpose of the study is to evaluate the     needs of long-term care for psychiatric patients. The first phase will identify the current     status of needs from the perspectives of patients and the family, psychiatric professionals,     and the system. The second phase will identify the goals of long-term care for psychiatric     patients. The goals will be identified by a nominal group, composed of experts related to the     field of psychiatric long-term care. The third phase will determine the objectives of     long-term care services for psychiatric patients. That is to determine the proper contents of     long-term care services for the patients based on the goals identified in the previous phase.      The three-phase needs assessment will be carried out in a two-year period. The results of the     study will provide important information to the future planning of long-term care for     psychiatric patients.   "
178572|NCT00172900|"     The white matter change of the Alzheimer's disease could be studied by diffusion tensor image     and MR spectroscopy to see the microstructral and biochemical change.   "
178573|NCT00172913|"     In the interest of improving visual quality after LASIK we have designed a multifaceted study     to test the theoretical, physical, biomechanical and functional effects of commercial and     independently designed aspherical ablation profiles.   "
178574|NCT00172926|"     Physical constitution is an important factor for the development and outcome of diseases     according to the theory in traditional Chinese medicine.      The purpose of the study is to find the correlation between physical constitution and     clinical characteristics (age, sex, symptoms, physical signs, life style, laboratory results     and image findings) through the questionnaire and results of health examination.   "
178575|NCT00172939|"     This current three-year proposal aims to clarify the mechanisms of melanocyte destruction and     regeneration in vitiligo lesions using both traditional cell culture and skin equivalent     model (organotypic culture).   "
178576|NCT00172952|"     To study the clinical characteristics and inheritance of pathological myopia in Taiwanese     patients.   "
178577|NCT00172965|"     Diagnosis of oral precancers and cancers using optic coherence tomography   "
178578|NCT00172978|"     To study the effect of elective pain relief analgesia in labor on mode of delivery.   "
178579|NCT00172991|"     Genetic studies of coronary artery disease, restenosis after angioplasty or stenting,     focusing on renin-angiotensin system genes and adiponectin gene, and their interactions.   "
178580|NCT00173004|"     Genetic studies of hypertension, focusing on renin-angiotensin system genes and other     interacting genes   "
178581|NCT00173017|"     Wearing N95 masks may have adverse physical effect on medical staff   "
178582|NCT00173030|"     Multi-locus and multi-gene studies of atrial fibrillation, focusing on renin-angiotensin     system genes and C reactive protein gene   "
178669|NCT00179816|"     This study uses a double autologous peripheral blood stem cell rescue (PBSC) following     dose-intensive chemotherapy for the treatment of high-risk pediatric solid tumors.   "
178844|NCT00183131|"     The objective of this project was to test the feasibility of electronic mail recruitment and     web screening for hazardous drinking, to compare different approaches to encouraging     screening, and to estimate the effects of minimal and more extensive feedback in preparation     for a future alcohol web-based brief intervention study   "
178583|NCT00173043|"     Polycystic ovary syndrome (PCOS) phenotype can be structured into three components:     anovulation, hyperandrogenism and the metabolic syndrome (of which hyperinsulinemia,     secondary to insulin resistance, is the central abnormality)(1). It is the most common     endocrinologic disease seen in Gynecologic clinic. The follicular excess in polycystic     ovaries and the failure of selection of one dominant follicle contribute to the anovulation     of PCOS. The infertile PCOS female usually suffered from difficult ovulation induction and     high risk of ovarian hyperstimulation syndrome because of extensive stimulation.      PCOS is the main androgen disorder in women and has been suggested to be associated with a     high risk of developing cardiovascular disease and type-2 diabetes. In many PCOS patients,     overweight or central obesity is generally associated with increases in fasting insulin     levels, insulin resistance, and glucose intolerance, and has been identified as a target for     new therapeutic strategy, including early change in lifestyle.      Insulin resistance, defined as decreased insulin-mediated glucose utilization, is commonly     (10-25%) found in the normal population. In women with PCOS, insulin resistance appears even     more common (up to 50%), in both obese and non-obese women.Hyperinsulinemia appears to play a     key pathogenic role in the ovarian androgen overproduction, because of the stimulatory effect     of insulin on ovarian steroid production.   "
178584|NCT00173056|"     Peritoneal fibrosis (PF) is one of the most serious complications after long-term continuous     ambulatory peritoneal dialysis (CAPD). Human peritoneal fibroblast (HPFB) and extracellular     matrix (ECM) deposition is the most possible causes leading to PF. ECM are mainly synthesized     from HPFB and human peritoneal mesothelial cells (HPMC). In the PF process, there is     decrement in the quantity of HPMC, loss of permeability for lower molecules, and eventually     ultrafiltration failure. This phenomena will result in technique failure.      High glucose content of the dialysate and peritonitis have been claimed as major stimulants     to the development of PF. In each episode of peritonitis, the number of HPMC will decrease.     On the other hand, ECM production will be reinforced by the inflammatory cytokines secreted     by the white cells or HPMC per se. High glucose dialysate will induce the above process with     more chronic stimulation, and PF followed by technique failure is inevitable.      Peritoneal fibrosis is definitively diagnosed with peritoneal biopsy, but this is     inconvenient for most patients. Besides, pathology changes will be noted only after a     substantial loss of peritoneal function. The peritoneal equilibration test (PET) is usually     used as the index of peritoneal function. However, in the chronic process, PET change is also     slow and is unable to be a parameter for treatment outcome. In this study, the factors     predicting PET change will be searched, and they could be an index for evaluation and even a     marker of preventing or treating PF.      In this project, peritoneal dialysis (PD) dialysate will be collected during an annual PET in     each PD patient in the National Taiwan University Hospital (NTUH). Some cytokines that will     be measured include vasculoendothelial growth factor, hyaluronan, transforming growth     factor-β, procollagen, and cancer antigen-125. The same test and measurement will be     performed during PET in the next year. The factors which affect PET results will be analyzed     such as cytokines, glucose exposure, peritonitis incidence, PD duration, gender, age. The     investigators will try to find a convenient acute reactive marker for preventing or treating     PF to monitor the PET change clinically.   "
178585|NCT00173069|"     This PPG entitled “A Study on Psychopathological Progress of Early Schizophrenia-like     Disorder (SOPRES)” is designed to study the “Progress of Psychopathology” of pre-psychotic     state of schizophrenia (SCH) using a prospective follow-up design. Based on the     neurodevelopment hypothesis of schizophrenia, the neurobiological dysfunctions, such as     cognitive impairment, neurophysiological dysfunction, neuroanatomical pathology, is the core     pathology. The pathology may exist prior to onset of psychotic symptoms, and at post     psychotic state. It also presents in the first-degree relatives. SCH is mainly with a gradual     mode of onset, ranging from pre-schizotypal (or pan-neurotic state), schizotypal, prodromal     to frank psychotic SCH (DSM-IV criteria) state.      Up to the present time, there are arbitray criteria for diagnosing schizotypal disorder and     frank psychiatric schizophrenia, but the valid clinical assessment method of pre-schizotypal     and prodromal state is still controversial. The psychopathological progress from     pre-schizotypal to frank psychotic SCH state is still unclear. In this SOPRES, we intend to     establish a set of valid clinical assessments for defining the cases of early SCH-like     disorder [ESLD], to examine the clinical progression, such as conversion rate of psychosis     from non-psychotic state in a prospective longitudinal follow-up; to validate the clinically     defined cases of ESLD with different dimensions of neurobiological studies, including niacin     skin flush test, neuropsychological, neurophysiological (such as prepulse inhibition [PPI],     P50 inhibition [P50I]), and magnetic resonance spectrometry (MRS) and Diffusion Tensor     Imaging (TDI); to demonstrate the validity of the ESLD using the family     genetic-epidemiological data and to explore the awareness, reaction, coping strategy, social     stigma, and help seeking process of the patients and the families of ESLD.      In order to achieve these goals, we designed this PPG of SOPRES, which comprises of 4     inter-locked projects and one core unit. Project No.1 is the “Clinical Phenomenological     Follow-up Study of ELSD: Clinical Validity”; Project No. 2 is the “Validity Study of     Neurobiological Tests of ELSD”; Project No. 3 is the “Validity Study of Family Genetic Study     of ELSD”; and Project No. 4 is the “Awareness and Pathways of Help Seeking of ELSD”. The only     one core unit is designed for the purposed of monitoring research progress, communication     among researchers such managing PPG research meeting, data management, and budget management     and other research-related administrative secretary work. These 4 projects are integrated     study approaches by means of (1) using the same samples; (2) study different levels of     psychopathology, including clinical symptoms, neurobiological impairment, family genetic     data, and psychosocial variables; and (3) mutual hypothesis testing.      We expect that this SOPRES research will create a new frontier of SCH research in the fields     of early intervention of SCH for preventing the recurrence of frank psychotic state of     schizophrenia, and will provide the background for improving treatment outcome and quality of     life of SCH.   "
178586|NCT00173082|"     Primary aldosteronism (PA) is occasionally associated with impaired glucose tolerance.     Glucose intolerance, in general metabolic syndrome is caused by suppression of insulin     release from the pancreas and suppression of insulin sensitivity of the target tissues.     Several studies have suggested that impaired glucose tolerance in primary aldosteronism is     due to an inability of the beta cells to release insulin by potassium depletion. It was     suggested glucose intolerance in PA is caused by the suppression of insulin release related     to hypopotassemia and compensatory increase of insulin sensitivity is observed in PA. The     increased insulin secretory capacity associated with correction of negative potassium balance     may account for the increase in plasma leptin after curing primary aldosteronism. The     conclusion with respect to the possible causal relationship between diabetes mellitus (DM)     and PA, however, can be obtained after the evaluation of the effect of surgical     /pharmacological treatment of PA.   "
178587|NCT00173095|"     According to Morgan et. al. (J Neurosurg 101:1026-1029, 2004): bilirubin as a cerebrospinal     fluid marker of sentinel subarachnoid hemorrhage: a preliminary report in pigs, we're going     to test the hypothesis in the cerebrospinal fluid of spontaneous subarachnoid hemorrhage     patients.   "
178615|NCT00173459|"     Severe acute respiratory syndrome (SARS) is an emerging infectious disease caused by a novel     coronavirus (SARS-CoV). The major clinical features of SARS include fever, dyspnea,     lymphopenia, and a rapid progression of pulmonary infiltrates on chest radiologic images. The     SARS-related deaths have resulted mainly from pulmonary complications, including progressive     respiratory failure due to alveolar damage and acute respiratory distress syndrome (ARDS).     Pathological changes in SARS suggest that SARS sequelae such as infiltration of PMN in lung     tissue, multiple organ dysfunction and ARDS have been associated with cytokines and chemokine     dysregulation. Some patients still manifested lung injury at a time when the viral load was     falling also supports the immune nature of the lung damage. We therefore undertook an     analysis of dynamic production of cytokine/chemokines in SARS patients with an initial normal     chest radiograph in order to improve understanding of disease pathogenesis and improve     patient management.   "
178845|NCT00183144|"     The purpose of this study is to determine whether the Therapeutic Workplace is effective in     increasing and maintaining long-term drug abstinence in homeless, alcohol dependent adults.   "
178588|NCT00173108|"     The first aim is to develop a clinic-based intervention program and a home-based intervention     program for VLBW preterm infants that have common intervention services but are respectively     delivered at clinic and home. The interventions are comprehensive that combine child- and     parent-focused services including health and feeding consultation, education of child     development skills, intervention of mother-infant interaction, and parent support. The     eleven-session interventions are intensive that begin in hospitalization and end at 12 months     of corrected age. The clinical feasibility and usefulness of implementing these intervention     programs within the context of randomized intervention study subject to the existing     constraints of the hospital and home settings will be tested in a pilot study.      The second aim is to conduct a randomized control trial to examine the costs and     effectiveness of the UCP, the CBIP, and the HBIP for VLBW preterm infants. Gender and     socio-economically matched normal full-term infants will also be included as a comparison     group. Outcome measures that include child, parenting, and transactions outcomes will be     compared between groups. Child outcome measures will include health status, growth,     neurodevelopment, and neurosensory status; parenting outcome measures will include maternal     parenting competence, social support, and psychological stress; transactions outcome measure     will be mother-infant interaction. Costs (direct and indirect costs) associated with each     early intervention program during the follow-up period will be estimated. Average and     incremental cost/effectiveness ratio will be calculated to determine which early intervention     program is most cost-effective for VLBW preterm infants.   "
178589|NCT00173121|"     From last decades, because of lacking the powerful quantitative methods, such as real-time     qPCR, there is no environmental monitoring data about enterovirus transmission. If the major     transmission routes and risk factor are still not clear, it will be very hard for making the     prevention and control strategies. Today, the most popular prevention suggestion for children     is keeping them away from crowded public places during the peak contagious season, because     enteroviruses are easily transmitted through aerosols over a distance of meters, and even     between separated rooms (Chang et al., 2004). However, adults may as easily be infected, but     don』t have any disease symptoms or carry the virus home. Another recommendation is washing     hands to avoid contact of hands or anything else with the mouth and nose, as it is through     contact of viruses with the mucosal membranes in the mouth and nasal passages that infection     occurs. However, these actions did not be great helpful for preventing enterovirus infection     and spread. Understanding and disrupting the major transmission pass way of enterovirus could     be more effective than just keeping personal hygiene. Therefore, an applicable environmental     monitoring program is needed for understanding the transmission routes and risk factor of     enterovirus infection. In this study, we will monitor enteroviruses in hospital, household     and kindergarten. For the environmental monitoring of enteroviruses, we will apply     traditional plaque assay, real-time quantitative PCR and combine with questionnaire-based     interviews to understand the infectious types and concentration of enterovirus from indoor     air, surface and water for recognizing the transmission routes of enterovirus and the     relationships between virus concentration and the symptoms of the cases.   "
178590|NCT00173134|"     Adult diabetic patients aged above 20 attending the diabetic clinic of National Taiwan     University Hospital are invited to attend a face to face screening and interview. After     obtaining the informed consent, questionnaires including IIEF, DAN-PSS-SEX and erectile     dysfunction effect on quality of lie are filled.Personal data, status of diabetes control and     complications of diabetes are recorded.The results will be used to investigate the prevalence     of erectile dysfunction of diabetic men in Taiwan and erectile dysfunction related quality of     life change.   "
178591|NCT00173147|"     Background：Patellofemoral pain syndrome（PFPS） is a common knee disorder characterized by     anterior or retropatellar pain associated with activities that load the patellofemoral joint.     Previous studies reveal that the vastus medialis obliquus（VMO） is an important dynamic medial     stabilizer of the patellar. Insufficiency of the VMO leads to lateral shift of the patella     and the increases the patellofemoral contact force. An in vitro study conducted by Hubbard     JK. et al. claimed that there were no significant relationship between several morphologic     characteristics of the VMO and the extent of patellofemoral joint deterioration. We consider     that the condition might be different in vivo, so we chose ultrasonogrphy as the measurement     tool to examine the morphology of the VMO in PFPS patients and healthy controls. Purpose：To     determine if there are significant differences in several morphologic parameters of the VMO     between patients with PFPS and healthy controls under 50. Method：31 PFPS patients and 31     matched healthy adults under 50 were recruited for the study. The HDI 5000 ultrasonography     machine was used to evaluate morphologic parameters of the VMO, including the percent of     patella attachment, fiber angle, the volume attached to the patella, and the change of shape     of the VMO.   "
178592|NCT00173160|"     This is the second-year part of a two-phase prospective epidemiological study as well as a     community case-controled study. The aims of the second year study are firstly, to investigate     the clinical course and 1-year outcome of eating disorders in the community, as well as the     prospective risk factors of eating disorders; secondly, a case-control design involving with     other psychiatric disorders from the same study population is used for risk factors study.      The study subjects are gifted dance high school students who participated the first-year     study and are willing to participate the 2nd-year study (N=675). Screening questionnaires for     eating disorders and general psychiatric disorders are EAT, BITE and CHQ-12. Other     self-report questionnaires include perfectionism subscale of Eating Disorder Inventor-I     (EDI), Rosenberg Self-esteem Scale (RSE), Eyseck Personality Scale, Pubertal Develoment     Scale, and body figure test. Subjects who received interviews at the first-year study and     those whose scores are above the threshold of the screening questionnaires need to receive     interviews at 2nd phase. The criteria of interview threshold included EAT≧20+ BMI<18.5Kg/m2,     symptom scale of BITE ≧15 and/or severity scale of BITE≧5, and CHQ ≧4. The content of     interview included structured diagnostic interview (SCID-IP 1995) as well as risk factors     assessment. Each time a subject with bulimia nervosa was recruited, one matched control     subject with no mental illness general psychiatric diagnosis was sought from the same class     or school. Potential psychiatric control subjects were identified from their scores on the     CHQ. The psychiatric control subjects were required to have no current or past eating     disorders. The contents of risk factor assessments include personal vulnerability and family     problems.      The relationships between individual risk factors and case status were assessed by univariate     analysis. Conditional logistic analysis was used for multivariate analysis of risk factors     prediction for eating disorders. To assess the relative importance of different types of     exposure, the relationship between case status and exposure in each domain were first     assessed by univariate analysis and then in multivariate stepwise regression analyses.   "
178706|NCT00181142|"     The purpose of this study is to compare outcomes in patients undergoing lung transplantation,     using 2 different induction therapies. Primary outcome is survival and secondary outcomes     include freedom from infection and freedom from rejection.   "
178707|NCT00181155|"     This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves     heart metabolism in patients with heart failure.   "
178593|NCT00173173|"     This is the first-year part of a two-phase prospective study. The aims of the study are to     investigate the prevalence rate of eating disorders in Taiwan, it's correlated psychosocial     risk factors and establish the validity index of BITE. The study subjects consist of     Taiwanese gifted dance high school students and age, sex, school-matched ordinary class     students. All students completed questionnaires(Eating Altitude Test(EAT-26), Bulimic     Investigatory Test, Ediburgh (BITE), Body Shape Questionnaire (BSQ), Physical Appearance     Related Teasing Scale, Pubertal Develoment Scale, and Brief Symptom Rating Scale (BSRS) at     first phase. All subjects who are above threshold (EAT-26 score≧20 and BMI≦17.5m2; the     symptom scale score of BITE≧15 and/or severity scale≧5),and 10% of the sub-threshold cases     need to receive second-phase interview by two senior psychiatrists. The contents of interview     included SCID-IP, and risk factors assessment for eating disorders. The known risk factors     included both personal factors (history of obesity, psychiatric, menstruation, teasing, or     sexual or physical abuse, etc.) as well as family factors (parental problems, history of     obesity, dieting, psychiatric illness etc.).      Statistical analyses were conducted using SPSS 10.0 for Windows/PC. Categorical data were     analyzed by nonparametric test (Chi-square test). ANOVA or Student’s t-test was used for     continuous data analyses. Reliability is assessed by internal consistency and test-retest     reliability. Inter-rater reliability was assessed by Kappa statistics. The sensitivity and     specificity for eating disorders were calculated for individual screening instrument.ROC     analyses were undertaken to evaluate the overall performance of the BITE +/- EAT in detecting     eating disorder cases. Regression analysis was applied to determine predictors of disordered     eating or eating disorder status. A value of P< 0.05 was considered statistically     significant.   "
178594|NCT00173186|"     The major risk factors of aortic valve replacement in three outlet types VSD after surgical     repair were the severity of preoperative AR and older operation age. For those patients with     less than moderate degree AR preoperatively, AR progressed rarely and all in those with     aortic valvar and subvalvar anomalies.   "
178595|NCT00173199|"     In order to increase our understanding about the pathogenic mechanism and the strategy of     treatment in the subtypes of Guillain Barré syndrome, we will check the temporal changes of     cytokines with different biological activities in serum and cerebrospinal fluid (CSF), check     the titer of various anti-ganglioside antibodies, perform skin biopsy and correlate these     data with the clinical findings such as severity and prognosis   "
178596|NCT00173212|"     Adenomyosis refers to the presence of endometrial glands and stroma that is haphazardly deep     within the myometrium. However, the etiology and pathologic mechanism responsible for     adenomyosis are not yet very well known. Our previous results revealed that the expression of     killer inhibitory receptors on natural killer cells was decreased in eutopic endometrium in     women with adenomyosis. It implies that the formation of adenomyosis might be due to abnormal     endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. Our     further investigation revealed that in vitro coculture of macrophages and endometrial stromal     cells (ESCs) increase the expression of IL-6 mRNA in ESC, which might further enhance the     proliferation of ESC and subsequently result in the formation of ectopic endometrial implants     in adenomyosis.      Abnormal cell proliferation has been generally found in the tumorigenesis, including the     formation of endometriosis. Adenomyosis is considered to have a similar pathophysiology with     endometriosis, and it must be interesting to examine whether there is abnormal cell     proliferation in the eutopic endometrium of adenomyosis. Lipopolysaccharide (LPS) was found     to promote proliferation of ESCs via induction of TNF-a and IL-8 expression, whereas IFN-g     significantly inhibited ESCs proliferation. Therefore, whether abnormal cell proliferation     occurs under the effects of LPS and IFN-g in the eutopic endometrium of adenomyosis needs     further clarification.      Adenomyosis preferentially affects women between the ages of 35 and 50 years, and the     symptoms subside gradually after menopause. It is well known that there is a close     conjunction between estrogen and adenomyosis. Estradiol (E2) was demonstrated to induce     endometrial cell proliferation, whereas medroxyprogesterone (MPA) inhibited endometrial cell     proliferation via antagonizing estrogenic effects. Experiments to investigate these steroid     effects on ESC proliferation in vitro in the eutopic endometrium of adenomyosis are of     clinical relevance.      In this study, we try to collect endometrial tissues from women with and without adenomyosis,     and then purify ESCs from endometrium. ESCs are cultured for 2 days with the supplement of     LPS, IFN-gamma, Estradiol, MPA and Estradiol+MPA. Quantification of cell proliferation was     done with Cell Proliferation Assay Kit and immunocytochemical detection of Ki-67, in an     attempt to examine the cell proliferation of ESCs in women with adenomyosis.   "
178597|NCT00173225|"     The aims of this study are to investigate the association between sputum and plasma levels of     nociceptin and substance P with cough severity and airway hyperreactivity in patients with     asthma, COPD and chronic cough.   "
178598|NCT00173238|"     Atherosclerosis is unquestionably the leading cause of morbidity and mortality in developed     countries, and the world-wide importance of acute vascular syndromes is increasing. Rupture     of atherosclerotic plaque has been identified as the proximate event in the majority of cases     of acute ischemic syndromes. Therefore, modalities capable of characterizing the     atherosclerotic lesion may be helpful in understanding its natural history and detecting     lesions with high risk for acute events.      Optical coherence tomography (OCT) is a powerful tool capable of tomographic imaging based on     low coherence interferometry. It is analogous to ultrasound imaging except that it uses     infrared light instead of sound. Polarization-sensitive optical coherence tomography (PS-OCT)     combines the advantages of OCT with additional image contrast of the sample. The added     contrast is based on the ability of PS-OCT to detect the birefringent properties of a sample     (phase retardation and fast-axis orientation) simultaneously.      The goals of this project are: 1) to examine whether PS-OCT is an acceptable tool for the     characterization of typical plaque constituents; and 2) to explain the correlation between     birefringence and forming or rupture of a plaque; and 3) to establish a quantitative PS-OCT     image criteria for atherosclerotic plaque characterization in vitro.   "
178599|NCT00173251|"     There are more and more macromastic women in Taiwan, which may due to the high cholesterol     foods. Patients with macromastia not only suffered from physical problems but also     psychological discomforts.   "
178600|NCT00173264|"     The purpose of this study is to determine whether the monoclonal protein in patients with     tuberculosis and monoclonal gammopathy has anti-tuberculous activity, and whether genes     coding their monoclonal proteins show characteristic mutations.   "
178601|NCT00173277|"     BACKGROUND: Primary screening with sigmoidoscopy would miss a substantial proportion of     advanced proximal neoplasia (APN), but screening with universal colonoscopy is costly. The     aim of this study is to assess the efficacy of mixed strategy which uses sigmoidoscopy for     younger patients and colonoscopy for older patients.      MATERIALS and METHODS: We analyzed an established database containing consecutive     average-risk adults aged 50 or older who underwent screening colonoscopy as part of health     check-up. We assessed the efficacy of mixed screening strategy using colonoscopy for persons     aged at and above a certain cut-off age and sigmoidoscopy for persons aged below that age.     Those who underwent sigmoidoscopy initially would be referred for subsequent colonoscopy if     distal sentinel lesion was detected.   "
178602|NCT00173290|"     In this study proposal, the investigators will extend their previous studies and examine the     kinetic cytotoxic activity with concordant expression of inhibitory natural killer (NK)     receptors (iNKR) on activated T cells. The inhibitory role of cytokines will be defined by     utilizing the investigators' previously established models of mixed lymphocytes and tumor     cells coculture to analyze the expression and activity of cytokines involved in the     regulation of iNKRs on cancer-encountered T cells.   "
187122|NCT00294801|"     comparative trial of placebo versus flex-a-new (a food supplement) containing glucosamine an     chondroitin sulfate for the symptom modification is knee osteoarthritis   "
178605|NCT00173329|"     Lately researchers and clinicians have emphasized the health related quality of life. Several     reasons account for this trend. First of all, the advanced medical practices have contributed     to the increased life expectancy. Secondly, the pattern of diseases has shifted from high     acuity to chronicity. Therefore, the effectiveness of health care could not be solely     evaluated by the rates of morbidity and mortality. The state of patients’ quality of life has     become the pivotal indicator of the effectiveness of health care interventions. On the other     hand, patients’ subjective perceptions of health care are crucial factors in treatment     processes. Therefore quality of life becomes reference in choosing health care interventions     to enhance the benefits of patients.      The scopes of quality of life research include the essence of quality of life, the     measurements of quality of life and the relationships between quality of life and its related     factors, etc. The local researchers have long put efforts in quality of life research. The     results of these studies have contributed to the understandings of different patients’     quality of life. However, the majority of studies have focused on specific diseases. This     study propose to extend the scope of quality of life research to study patients’ quality of     life of two severe illnesses, i.e. HIV infections and schizophrenia. These two illnesses     represent two severe physical and psychiatric illnesses. Even their etiology, mechanisms,     disease process, signs and symptoms, and treatments are different. However, the similarities     of these two illnesses include both are severe illnesses without cure, both are stigmatized     by the society. Patients with these two illnesses suffer in their personal lives, social     relations and quality of life. Therefore the current study to further investigate and compare     and contrast the essence of patients’ quality of life and their related factors.      The proposed study is a second year study of the two-year study - The quality of life of     patients with severe illnesses (NSC93-2314-B-002-294). The first year study focused on the     investigation of the quality of life of patients with HIV infections (NSC93-2314-B-002-294).     The aim of this proposed study is to compare and contrast the quality of life and its related     factors of patients with schizophrenia and HIV infections. The contributions of this study     include the in-depth understandings of quality of life of patients with HIV infections and     schizophrenia and the comparison of quality of life of different illnesses. The results serve     as the foundations in future development of intervention programs to enhance patients’     quality of life and cost-effectiveness analyses.   "
178606|NCT00173342|"     This study is to determine 1) the incidence of altered right bundle conduction, including     CRBBB, IRBBB or rsR’ pattern in the Taipei city based on the school survey databank from 1999     to 2002, 2) the associated cardiac lesions, 3) clinical presentations relevant to the altered     right bundle conduction, 4) the association with QTc prolongation and dispersion and HRV from     a 5-minutes recording. Finally, molecular characterization for those with CRBBB or Brugada     pattern EKG, especially those with positive family history will be studied.   "
178607|NCT00173355|"     Retrospective review of clinical outcome of pediatric Dermatofibrosarcoma Protuberans (PDFSP)     after active invitation   "
178608|NCT00173368|"     Using a needle knife papillotome by an experienced endoscopist, endoscopic sphincterotomies     were performed in difficult cannulation cases. In a prospectively collected database, we     investigate the complications of those with ampullary impacted stone.   "
178609|NCT00173381|"     The purpose of this study is to investigate the role of lymphangiogenesis in the metastasis     of head and neck cancer.   "
178610|NCT00173394|"     Ovarian cancer is the first in mortality rate of the gynecologic malignancies and the overall     5-year survival rate of ovarian cancer is only 20–30%. Besides, the incidence of ovarian     cancer increased in recent years in Taiwan. Ovarian cancer is indeed a disease that should be     respected, however, there has only been a little research done focusing on it in Taiwan.     Patients with ovarian cancer who have stage I disease (localized to ovaries) after optimal     surgical staging do not need any adjuvant therapy. In contrast, patients with disease     spreading beyond the ovaries have median survival rates that decrease to < 10% for patients     with bulky residual disease after surgery and treated with platinum-based combination     chemotherapy. In developing effective therapy for ovarian cancer, there should be a     distinction between preventative and therapeutic approaches. Immunoprevention will be     developed for women who are at an increased risk for the development of ovarian cancer. In     contrast, immunotherapy would be used as an adjuvant to surgery or in combination with     chemotherapy or other biologics as chemoimmunotherapy or biochemoimmunotherapy. Mesothelin is     expressed in some normal epithelial cells and is elevated in certain carcinomas. Mesothelin     has been reported to be selectively overexpressed in most of the non-mucinous ovarian     carcinomas. In addition, the specific epitopes of mesothelin in the HLA-A2 and A24 haplotype     have been identified. It seems that mesothelin has the potential to be a target antigen for     the immunotherapy of ovarian cancer.      So the investigators would like to provide this proposal to address the development of     mesothelin -specific immunologic assays. There are two aims in this project:        1. to develop and utilize assays to measure cytotoxic T lymphocytes (CTLs) to mesothelin,          and        2. to evaluate the mesothelin-specific immunologic responses between normal control and          ovarian cancer patients.   "
178611|NCT00173407|"     We have identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion     suppressor gene in ovarian endometrioid carcinoma, and showed association with lower cancer     migration, invasion and metastasis. Recently, a novel model of ovarian EC formation from     endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation     of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of     the major epigenetic changes. This tumorigenesis model has lots of similarity to our     established invasion model. Therefore, we plan to study the important of PTEN expression in     ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by     studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to     study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in     ovarian EC.   "
178612|NCT00173420|"     In order to clarify the normal components of thermal and painful evoked potentials by heat in     normal subjects of both genders and different age group, to clarify the effect of specific     anatomy in pain transduction, transmission and modification, and to establish the effect of     peripheral nerve and their terminal free ending on the nociceptive transduction, the     investigators will use heat stimulation on normal controls and patients with neurological     diseases to clarify such issues.   "
178613|NCT00173433|"     we hypothesize that exogenous reinfection is very important in the Taiwan endemic. Therefore,     we design a series of studies to evaluate the individual contribution of exogenous     reinfection and endogenous reactivation in the Taiwan endemic, and to realize the impact of     exogenous reinfection. First, we will identify the patients with TB relapse after complete     treatment. The M. tuberculosis isolates responsible for their initial and recurrent episodes     will then be genotyped to clarify the percentage of exogenous reinfection and endogenous     reinfection.   "
178614|NCT00173446|"     Dopamine (DA) is one of the main catecholamines in mammals. Its major role as a brain     neurotransmitter is well known as well as its contribution to the development of pathologies,     mainly arterial hypertension. Traditionally, dopamine receptors are divided into two families     according to the stimulation or inhibition they may produce at the adenyl cyclase level. Five     dopamine receptors have been identified: D1 (D1a) and D5 (D1b) exist in the D1 family. D2s,     D2l, D3 and D4 belong to the D2 family. Formerly, less than 1% of patients with hypertension     were believed to have primary hyperaldosteronism; however, recent studies have suggested that     primary aldosteronism affects 5-13% of patients with hypertension and aldosteronomas are a     more common cause of hypertension than previously thought. At least 2% of patients with     hypertension may have an aldosteronoma. The investigators' previous clinical observation     found two subtypes of aldosterone-producing adenoma (APA), which were defined according to     their responses to metoclopramide during salt manipulation. On a high-salt diet (HS), the     nonsuppressible subjects, with less dopaminergic inhibition of aldosterone secretion, had     less urinary DA excretion and greater blood pressure (BP) elevation [Wu KD et al. 2002]. The     investigators' recent study of six patients with an APA found that the expression of the D2     receptor in APA was not universal. The amounts of D2 receptor messenger ribonucleic acid     (mRNA) were more variant in either APA or their remnant adrenal glands. Only two cases of APA     expressed the D2 receptors with much weaker signals compared with those in their respective     remnant adrenals [Wu KD et al. 2001]. The investigators' current work demonstrates that the     D2 receptor negatively regulates AII-stimulated aldosterone secretion and aldosterone     synthase mRNA expression in NCI-H295R cells. On the other hand, the D4 receptor counteracts     with the effect of the D2 receptor. In a future study, the investigators wish to quantify D2     and D4 receptor mRNA and protein expression in APA and their remnant adrenal glands and     correlate them to their clinical metoclopramide test results. The investigators also wish to     know whether the difference between the D2 and D4 receptor expression reflect the different     effects of dopamine inhibition on AII-stimulated aldosterone secretion and aldosterone     synthase transcription. Finally, the investigators will explore the role of D2 and D4     receptors on AII-stimulated adrenal cell proliferation.   "
178616|NCT00173472|"     The present project will follow our previous phaseⅡ study of FOLFOX regimens for the     treatment of stage Ⅳ colorectal cancer. We will recruit at least 200 patients for this study.     The selection of patients will be based on rigorous eligibility criteria. The patients will     be allocated based on the expression of each molecular marker (MSI, TS, DPD, MVD and EGFR)     and the implementation of chemotherapy. For example, in the examination for the clinical     implications of EGFR, the patients will be classified into four groups: EGFR（＋）     chemotherapy（＋）; EGFR（＋） chemotherapy（－）; EGFR（－） chemotherapy（＋）; EGFR（－） chemotherapy（－）.     Base on the analysis of this 2×2 table, we will clarify the prognostic significance of a     specific molecular marker is due to whether the specific molecular marker predicts biological     invasiveness and/or chemosensitivity. We believe the present study will have the following     significance: （1）To further clarify the mechanisms for the carcinogenesis and progression of     CRC; （2）To facilitate the development of novel chemotherapeutic agents; and （3） To gain the     experience for the practice of evidence-based medicine.   "
178617|NCT00173485|"     A progressive decline of plasma triggering receptor expressed on myeloid cells-1 (TREM-1)     concentration indicates a favorable clinical evolution during the recovery phase of sepsis.     The expression of TREM-1 in dialysate of peritoneal dialysis patients was not yet documented.     We will collect the dialysate of peritonitis in peritoenal dialysis patients and analyze the     time serial change.   "
178618|NCT00173498|"     To analyze the common allergens revealed by skin tests in adult atopic dermatitis patients.   "
178619|NCT00173511|"     Background:      Upper gastrointestinal (GI) bleeding, a common disorder encountered at emergency room, may     cause hypotension and tachycardia that may in turn result in myocardial ischemia in patients     with coronary artery disease (CAD). An emergent endoscopy with hemostasis is the mainstay of     management. However, endoscopy itself may result in myocardial ischemia. Whether myocardial     ischemia and arrhythmia occurs more frequently during emergent endoscopy in patients with CAD     remains unknown.      Objective:      To determine whether the risk of myocardial ischemia and arrhythmia is increased during     emergent endoscopy in patients with CAD.      Method:      Adult patients with documented CAD undergoing emergent endoscopy due to UGI bleeding are     included. Adult patients without CAD undergoing emergent endoscopy due to UGI bleeding were     included as the control group. The expected case numbers were 50 patients in each group.     Patients with terminal illness, pregnancy, active lung disease requiring ventilator support     are excluded. Before endoscopy, symptoms of myocardial ischemia, blood pressure, heart rate,     O2 saturation, hemogram, baseline 12-lead EKG, and cardiac enzyme are obtained. All patients     are monitored with Holter EKG since 10 minutes before endoscopy to 2 hours after the     procedure. Blood pressure, heart rate, and O2 saturation are closely monitored during the     procedure. Endoscopy is performed by experienced endoscopist and endoscopic hemostasis is     done according to the types of lesions. The duration of endoscopy, types of endoscopic     hemostasis, and blood pressure are recorded. After endoscopy, symptoms of myocardial     ischemia, blood pressure, heart rate, O2 saturation, hemogram, baseline 12-lead EKG, and     cardiac enzyme are checked again.      Keywords: Emergent endoscopy, coronary artery disease, cardiovascular events   "
178620|NCT00173524|"     The objective of this pharmacoeconomics (PE) study is to evaluate the cost- effectiveness     analysis and cost-utility analysis of IRESSA® as first line treatment of NSCLC from the     society perspective, based on resources and outcomes from patients who met the inclusion     criteria for this naturalistic study comparing to existing first line platinum-based regimen     chemotherapy.   "
178621|NCT00173537|"     Primary pulmonary hypertension (PPH) is a rare lung disorder in which the blood pressure in     the pulmonary artery rises far above normal levels for no apparent reason. The pulmonary     artery is a blood vessel carrying oxygen-poor blood from the right ventricle (one of the     heart's pumping chambers) to the lungs. In the lungs, the blood picks up oxygen, then flows     to the heart's left side, where the left ventricle pumps it to the rest of the body through     the aorta. In the United States, an estimated 500 to 1,000 new cases of primary pulmonary     hypertension are diagnosed each year. The greatest number is reported in women between ages     20 and 40. However, men and women in all age ranges as well as very young children can     develop PPH. Researchers have identified more than 40 BMPR2 mutations that can cause primary     pulmonary hypertension. Many of these mutations introduce a stop signal that halts protein     production prematurely, decreasing the amount of functional BMPR2 protein. Other mutations     prevent the BMPR2 protein from reaching the cell surface, or alter its structure so it cannot     form a complex with other proteins. It remains unclear how BMPR2 mutations cause primary     pulmonary hypertension. Researchers suggest that a mutation in this gene prevents cell death     or promotes cell proliferation, resulting in an overgrowth of cells in the blood vessels of     the lungs. Cell overgrowth can narrow the diameter of the vessels, restricting blood flow and     resulting in elevated blood pressure. However, it has not yet been reported regarding the     genetic variants in Taiwan. Further details have been described in this project proposal.   "
178622|NCT00173550|"     The aim of this study is to survey patient’s cognition and attitude about health-related     quality of life, use of estrogen, experience of menopausal syndrome, compliance of     medication, experience, and satisfaction for women who underwent hysterectomy and bilateral     oophorectomy before menopause.   "
178636|NCT00173732|"     Preimplantation genetic diagnosis (PGD) is the integration of both assisted reproductive     technologies and molecular genetic technologies and was shown to improve implantation rate     and reduce spontaneous abortions after implantation. The principal problems in single cell     PCR include amplification failure, ADO and contamination. Multiple displacement amplification     (MDA) is a technique used in the amplification of very low amounts of DNA and reported to     yield large quantities of high-quality DNA. By this approach, the diagnosis of gene disorders     form single cell will be more accurate and reliable.   "
178637|NCT00173745|"     The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to     treat drooling in children with cerebral palsy, and to find the most appropriate dosage,     duration of effect and side effects.   "
178723|NCT00181532|"     The purpose of this study is to investigate the effect of the adminstration of celecoxib, a     cox2-inhibitor in patients with stage II-III non small cell lung cancer receiving radical     radiotherapy.      The hypothesis is that celecoxib will increase the remission rate of radiotherapy.   "
178623|NCT00173563|"     Severe acute respiratory syndrome (SARS) is a new emerging infectious disease. Its pathogen     is a newly discovered coronavirus (SARS-CoV). The clinical course can be classified to 3     stages: viral replication phase, hyperimmune reactive phase, and pulmonary destruction phase.     Human monocyte plays a critical role in the initiation of immune response in defending the     intracellular pathogens (eg viruses). Monocytes can engulf viruses and present the viral     antigens in the major histocompatibility (MHC) molecule to the cell surface to initiate T     lymphocyte response. Monocytes also secrete various cytokines to modulate immune response.     SARS-CoV is a mutant of animal virus to cause human disease and is able to cause unusual     severe respiratory illness. It is suggested the unusual severe disease is due to the intense     immune reaction.      The investigators will harvest human monocytes from healthy adult and children blood donors.     Monocytes would be cultured and infected by SARS-CoV. The change of viral load is monitored     after infection. Cytokines secreted by monocytes after infection are also measured. The     difference of monocyte cytokine secretion is compared between adults and children. The study     is to verify the SARS-CoV infectivity of human monocytes and prove the unusual severity     caused by SARS-CoV is related to viral-induced dysregulation of cytokine responses. The     results may also clarify why adults tend to have a more severe illness compared with     children.   "
178624|NCT00173576|"     Severe acute Respiratory Syndrome (SARS) is an emerging infectious disease. It is caused by a     novel SARS-associated coronavirus. According to the epidemiological data, it is highly     infectious by intimate contact, respiratory secretion, or direct contact with infectious body     fluid. By June 1, 2003, Center for Disease Control Taiwan, R.O.C reported 677 probable SARS     cases. Among them, 93.2% (631/677) were more than 20 years old. Only 6.8% (46/677) were under     20 years old. Usually the major hosts of respiratory viruses are children, but evidence up to     now shows that SARS is mainly a disease of adults. The data of clinical presentation and     epidemiological prevalence in teenage group and children are lacking. Therefore, this project     is aimed at the children and teenager among 1 month to eighteen years old. Seroepidemiology     of SARS-CoV infection in children would be investigated. Patients who admitted to pediatric     wards or visited ER and received blood sampling due to the need of clinical     diagnosis/management would be enrolled. After the necessary laboratory examinations were     done, the remaining serum would be collected and tested for anti-SARS-CoV IgG by ELISA.   "
178625|NCT00173589|"     Inflammatory and Fibrotic protein markers in patients with atrial fibrillation   "
178626|NCT00173602|"     The investigators want to evaluate the burden of peripheral artery occlusion disease in     Taiwan peritoneal dialysis (PD) patients by using ankle-brachial pressure index (ABI) and     toe-brachial pressure index (TBI). Furthermore, the investigators hope to demonstrate the     possible casual factors of peripheral artery occlusion disease (PAOD) in PD patients.   "
178627|NCT00173615|"     Analysis of the patients' data who were rescued with extracorporeal membrane oxygenation and     without ECMO. The survival rate and the weaning rate were analyzed to see the effect of ECMO     on the prolonged CPR.   "
178628|NCT00173628|"     Evaluate the autoantibodies, such as glutamic acid decarboxylase (GAD65), tyrosine     phosphatase (IA-2 or ICA125), islet autoantibodies (IAA) and other associated autoimmune     autoantibodies: microsomal antibodies, thyroglobulin antibodies, gastric parietal cell     antibodies in patients with type 1 DM.   "
178629|NCT00173641|"     Evaluate the regulatory T cell function in patients with type 1 diabetes mellitus, and find     the pathogenesis of this autoimmune disease.   "
178630|NCT00173654|"     To disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.   "
178631|NCT00173667|"     Objective:        -  To evaluate the antihypertensive efficacy of two brands of nifedipine 30mg in patients          with hypertension.        -  To assess the safety of 8 weeks of therapy with two brands of nifedipine 30mg in          patients with hypertension.        -  To study flow-mediated dilatation and oxidative stress in nonsmoker with essential          hypertension but without diabetes mellitus or dyslipidemia.      Study Design:        -  Head-to-head, randomized and parallel design.        -  A total of 60 patients with a clinically confirmed diagnosis of hypertension will          provide 30 available patients in each treatment group.        -  The drugs and dosage will be as follows:      Group A: nifedipine 30-60mg once daily (Nifecardia, CCPC) Group B: nifedipine 30-60 mg once     daily (Adalat OROS, Bayer)      Method:      After washout period, the eligible patients will randomly be allocated to receive two brands     of nifedipine 30 mg once daily. Each patient will receive two times of ambulatory blood     pressure measurement (ABPM) at both entrance and final stages of the study. The patients will     also undergo complete clinical evaluation. Therapy dosage will be started at a dose of     nifedipine 30 mg once daily. Dosage will be adjusted if systolic blood pressure greater than     140 mmHg or diastolic blood pressure greater than 90 mmHg by office measurement after 4 weeks     of treatment. Nifedipine will be increased to 60 mg once daily. The Ambulatory blood pressure     measurement will be set to take reading at 1-hour intervals during the 24 hours assessment.      Physical examination included the measurement of heart rate and blood pressure. The value     will be read on Visit 1 and 3-12 hours after the last dose of nifedipine. Routine laboratory     test includes hematology, blood chemistry and urinalysis. Hematology test and fasting blood     chemistry test will be measured immediately before the start of treatment and after 8 weeks’     treatment or at time of discontinuation. Thiobarbituric acid–reactive substances (TBARS) in     patient plasma were measured for oxidative stress and endothelium-dependent flow-mediated     vasodilation will also be evaluated. Possible concomitant medication will remain constant     throughout the study. The physician will question the patients as to their compliance at each     visit. If compliance dose not reach 80%, the subject will be dropped out.   "
178632|NCT00173680|"     This project is to study the methylation status of the transcriptional regulatory region of     CD44 gene in surgically resected NSCLC specimens and normal lung tissue, correlate the     methylation status of promoter region with the expression of CD44 gene, and analyze if     methylation is associated with survival.   "
178633|NCT00173693|"     This study aims to conduct a cost-effectiveness analysis (CEA) among the programs for     preventing osteoporotic fracture. The main comparison will be made among the effects of three     programs for preventing osteoporotic fractures: 1. health education; 2. exercise intervention     for enhancing bone mineral density (BMD); 3. exercise intervention for preventing falls. The     cost will be measured bases on the monetary cost of implementation of each program. The     effectiveness will be measured includes the number of prevented osteoporotic fractures of     each program, and related outcomes are the follows: 1. the medical cost of osteoporotic     fracture; 2. the change of BMD in consecutive years; 3. the quality of life (QOL) of patients     with osteoporotic fracture as compared to the reference population.   "
178634|NCT00173706|"     This is a study designed to test the hypothesis that treatment with L-carnitine will improve     the quality of life and some specific symptoms and signs in patients with renal failure     submitted to hemodialysis.   "
178635|NCT00173719|"     The primary purposes of the this three-year research proposal are to investigate the     influence of assistive device use on dynamic balance and the associated attentional demands     during standing and walking in patients with stroke   "
178638|NCT00173758|"     Human decidual tissue appears to play an important role not only in nurturing the implanted     embryos, but also in preventing its rejection by the maternal immune system. Insight into the     maternal immunologic modulations during implantation is our main research interests. Our     previous studies have shown that most lymphocytes in deciduae are natural killer cells.     However, their phenotype is CD16-CD56+CD3-, which is different from that of peripheral     natural killer cells. More importantly their cytotoxic activity is decreased and they can’t     attack the cytotrophoblasts. All of these contributes to no rejection developing at the     fetomaternal interface and are related to success of pregnancy.      In 1994, a new cytokine IL-15 was first discovered, which could act on the IL-15 and IL-2     receptors to stimulate the activation and propagation of the lymphocytes. Let us want to     study the critical role of IL-15 in the endometrial lymphocytes. In this study, we try to     analyze the distribution of IL-15 and its receptor in deciduae. We will clarify whether the     IL-15 receptor exists on the decidual natural killer cells and it is regulated by sexual     hormones or not and whether their cytotoxic activity will change after IL-15 action.     Furthermore, we will demonstrated whether the IL-15 receptor exists on the embryo cells and     IL-15 might improve the quality of the embryo. We also design a co-culture system of the     embryo and autologous endometrial cells to improve the success rate of in vitro     fertilization.   "
178639|NCT00173771|"     our research team will develop a new CADL scale for stroke patients over the next three     years.      In the first year, we had established a CADL item bank of 50 items. The investigators will     administer the 50 items on 300 patients with stroke living in the community. Then we will     select 10 to 15 items from the item bank for the CADL scale based on the International     Classification of Functioning, Disability and Health (ICF), the opinions of an expert panel,     and Rasch analysis. It is anticipated that the CADL scale will have unidimensionality, an     interval level of measurement, soundly psychometric characteristics, a reduced number of     items, and ease of administration.      In the second and third years, we will compare the psychometric properties of the CADL scale     and the combined BI and FAI scale. The psychometric properties investigated will include     reliability (e.g. inter-rater reliability, intra-rater reliability, and internal     consistency), validity (e.g. concurrent validity, convergent validity, predictive validity     and discriminant validity), and responsiveness. A total of 150 patients will be recruited.     Both the CADL scale and the combined BI and FAI scale will be used on patients from the     initial stage (within one month) to six months after hospital discharge. The results will be     useful for researchers and clinicians to determine whether the CADL scale is better than the     combined BI and FAI scale in stroke patients.   "
178640|NCT00173784|"     This study is to develop an IADL Scale for patients with SCI (IADL-SCI) and examine its     psychometric properties in three years.   "
178641|NCT00173797|"     This study is going to comprehensively examine the psychometric properties of the three     depression scales (Hamilton depression scale (HAMD), Hospital anxiety and depression scale     (HADS), and Beck Depression Inventory (BDI)) in stroke patients over a period of three years.   "
178642|NCT00173810|"     We will employ modern test theory (i.e., Rasch model) to refine the Stroke Rehabilitation     Assessment of Movement instrument (STREAM), which will be called the refined version of the     STREAM, R-STREAM).   "
178643|NCT00173823|"     According to the reports of the United States Renal Data System (USRDS), there is a 25%     annual mortality rate with nearly 50% of all reported maintenance hemodialysis (HD) patient     deaths attributed to atherosclerosis-related complications. Although traditional risk factors     of cardiovascular disease (CVD) are common in end-stage renal disease (ESRD) patients, they     alone may be insufficient to account for their high prevalence of CVD. Recent evidence     demonstrated high plasma homocysteine levels have been established as a risk factor of     chronic inflammation and atherosclerosis in patients with ESRD.      Malnutrition and inflammation was associated with poor quality of life, morbidity and     mortality. We, the researchers at National Taiwan University Hospital, hope to establish the     best predictive profile of HD patient outcome. Thus, we establish several protocols to     complete this work.   "
178644|NCT00179491|"     Intercessory prayer is widely believed to influence recovery from illness, but claims of     benefits are not supported by well-controlled clinical trials. Prior studies have not     addressed whether prayer itself or knowledge/certainty that prayer is being provided may     influence outcome. We evaluated whether (1) receiving intercessory prayer or (2) being     certain of receiving intercessory prayer was associated with uncomplicated recovery after     coronary artery bypass graft (CABG) surgery.   "
178645|NCT00179504|"     Stress contributes to health and behavioral issues in students, but will not be integrated     into schools without evidence of benefit. This study was conducted to determine if a 6-week     relaxation response (RR) curriculum improves cognitive performance in ninth grade students.   "
178646|NCT00179517|"     The purpose of this study is to determine if treatment using a medication     (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a     tablet that does not contain any active medication, when combined with testosterone     replacement to treat reproductive and sexual dysfunction in men with epilepsy. Anastrozole,     the medication that is currently under study, does not, at this time, have FDA approval for     use for this indication.   "
178647|NCT00179530|"     To evaluate whether a 5-week relaxation response intervention influences the learning, memory     or attention of healthy older adults.   "
178648|NCT00179543|"     The purpose of this study is to determine whether the relaxation response is more effective     than attention control in reducing blood pressure and medication dosage in elderly adults     with isolated systolic hypertension.   "
178649|NCT00179556|"     Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of     life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy     for hot flashes. The study examines the effect of a new soy supplement, as compared to a     placebo, in menopausal women on hot flash symptoms.   "
178650|NCT00179569|"     The purpose of this study is to examine the molecular (nitric oxide) and biochemical     (epinephrine, norepinephrine, cortisol and ACTH) parameters that are associated with RR     elicitation and which may counteract the effects of acute stress in the elderly.   "
178651|NCT00179582|"     To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBS   "
178654|NCT00179621|"     The purpose of this study was to compare 2 doses (10 mg and 5 mg) of lenalidomide to that of     placebo in subjects with red blood cell (RBC) transfusion-dependent low- or     intermediate-1-risk IPSS MDS associated with a deletion (del) 5q[31] cytogenetic abnormality.     Study participants were randomized to one of the two treatment groups or to placebo and took     the study drug for 16 weeks. At this timepoint, participants were evaluated for erythroid     response. If participants did not achieve at least a minor erythroid response, they were     discontinued from the Double-Blind phase and entered into the Open-Label phase. All erythroid     responders at Week 16 were to continue in the Double-Blind phase for up to 52 weeks. For     participants that were still responding at the end of Double-Blind phase, they could then     rollover into the Open-Label phase for an additional two years. Participants could remain on     study for up to a total of 3 years. All participants who discontinued from the study were     followed every 4 months for overall survival and progression to acute myeloid leukemia (AML).   "
178655|NCT00179634|"     This is a study to assess whether healing suggestions and enhancing visual milieu (large fine     art photographs) will improve mental and physical measures of well-being and recovery from     surgery. The study will compare breast cancer patients undergoing identical skin sparing     mastectomy and reconstruction surgery randomized to three groups:        1. Usual care control group        2. Usual care and exposure to fine art photograph        3. Usual care and fine art photograph and guided visualization tapes.   "
178656|NCT00179647|"     Subjects who qualify for participation will receive lenalidomide with or without     dexamethasone in 4 week cycles until disease progression is documented or lenalidomide     becomes commercially available for the indication of multiple myeloma.   "
178657|NCT00179660|"     To determine the activity of lenalidomide in relapsed or refractory aggressive NHL.   "
178658|NCT00179673|"     Participants who qualify will receive lenalidomide daily on days 1-21 of every 28 day cycle.     Treatment will continue for up to 52 weeks or until disease progression; participants who     achieve a complete response (CR) will receive an additional 2 cycles of treatment prior to     discontinuation. Participants will be followed for progression free survival following     discontinuation from the treatment phase   "
178659|NCT00179686|"     Subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day     cycles. Subjects will continue until disease progression is documented.   "
178660|NCT00179699|"     Study will deteremine the MTD and evaluate the safety profile of oral lenalidomide on days     1-14 when combined with pemetrexed on day 1 of a 21 days cycle. Subjects will continue on     study until documention of disease progression.   "
178661|NCT00179712|"     Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days     1-14 when given with topotecan on days 1-5 of every 21 day cycle Phase II will commence once     the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on     days 1-14 with topotecan on days 1-5 in 21 day cycles until disease progression is     documented.   "
178662|NCT00179725|"     Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days     1-21 when given with liposomal doxorubicin on day 1 of every 28 day cycle Phase II will     commence once the MTD is established, additional subjects will be enrolled and receive oral     lenalidomide on days 1-21 with liposomal doxorubicinon day 1 in 28 day cycles until disease     progression is documented.   "
178663|NCT00179738|"     Subjects who qualify will receive single agent oral lenalidomide daily on days 1-21 every 28     day cycle. Subjects will continue on study until documented disease progression   "
178664|NCT00179751|"     Phase I will determine the MDT and evaluate the safety profile of oral lenalidomide days 1-21     and weekly gemcitabine days 1, 8, & 15 in 28 day cycles Phase II will explore the anti-tumor     activity and safety of the combination in subjects with advanced pancreatic carcinoma.     Subjects will receive oral lenalidomide days 1-21 and weekly gemcitabine days 1, 8, & 15 in     28 day cycles until documented disease progression occurs.   "
178665|NCT00179764|"     The purpose of this research study is to evaluate the effectiveness of transplantation of     high doses of peripheral blood stem cells (stem cells are special cells found in the blood     and bone marrow that produce new blood cells) after treatment with non-myeloablative     chemotherapy (not toxic to the bone marrow). In addition, this study will assess the side     effects of the transplant.   "
178666|NCT00179777|"     The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) is an international effort to     conduct a primary prevention nutrition trial for type 1 (insulin-dependent) diabetes. The     TRIGR study is targeted at newborns who are at genetic risk for type 1 diabetes because their     mother, father and/or full sibling has type 1 diabetes. All families are encouraged to breast     feed their infants for as long as possible. Prior to birth, the child is randomly assigned to     receive one of two infant formulas, should formula be required prior to 8 months of age. The     study will determine whether weaning to a possibly protective infant formula decreases these     children's chances of developing diabetes - as it does in the animal models for diabetes.   "
178667|NCT00179790|"     Stem cell transplantation may be used to cure childhood cancers, and other diseases.     Traditionally, stem cell transplants use high doses of chemotherapy and radiation. This     regimen may cause significant problems after transplant such as infertility, infection, and     graft versus host disease (GVHD).      Reduced intensity transplant (RIT) uses medications which weaken the immune system, allowing     donor cells to take over. The goal of a RIT is to reduce the risk for complications after     transplant. Usually medication is used to weaken the immune system, but there are other     options such as extracorporeal photopheresis (ECP) that may be less toxic.      ECP is currently used for the treatment of GVHD and certain lymphomas. ECP uses a machine     that filters white blood cells from the blood, treats them with ultraviolet (UV) light, and     then gives all the cells back to the patient. The patient's immune system becomes weaker,     allowing the donor cells to replace those of the patient. Studies involving the use of ECP     for conditioning have shown fewer side effects than the use of medications.      The primary purpose of this clinical research trial is to evaluate the safety and feasibility     of ECP as part of a preparative regimen for RIT in children and young adults.   "
178668|NCT00179803|"     The primary goal of this study is to determine if a stem cell transplant in patients with     newly diagnosed high risk CNS tumors (glioblastoma multiforme [GBM], high grade astrocytoma,     pineoblastoma, rhabdoid tumor, supratentorial primitive neuroectodermal tumor [PNET])     increases overall survival.   "
178670|NCT00180661|"     Some patients with mild asthma may develop severe asthma. It is not known what makes patients     with mild asthma become severe, and we plan to find out why this happens. Patients with     severe asthma may have a different type of inflammation in the airway tubes. Patients with     severe asthma do not get as much benefit from taking steroid inhalers or tablets compared to     asthma patients with mild disease. The study hypothesis is that the inflammation in severe     asthma is such that it makes steroids less effective in treating asthma. We will find out     what possible abnormalities there are in the blood cells and the bronchoalveolar macrophage     cells in the lungs of patients with severe asthma compared to those with mild or moderate     asthma.   "
178671|NCT00180674|"     Patients who have been treated for hepatitis C virus (HCV) infection who have failed to     respond to anti-viral treatment are often concerned about their ongoing liver disease and are     therefore looking for alternative treatments which might prevent fibrosis progression. This     view is endorsed by patient representative groups (including Charles Gore at the HepC Trust)     who have welcomed this trial protocol.      The trial will be a randomised cross over study with 15 patients in each group. Each patient     will receive eight weeks of anticoagulation and eight weeks of observation.   "
178672|NCT00180687|"     Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control,     one will have local anaesthetic and the third will have normal saline nebulised into their     abdomen before closure of the wounds to reduce postoperative pain. These medications will be     given on top of the standard pain management protocol.   "
178673|NCT00180700|"     This study examines the hypothesis that psychological interventions have beneficial effects     on quality of life including psychological well-being and disease progression in early HIV     patients recieving no medication.   "
178674|NCT00180713|"     The purpose of the study is to investigate the safety and efficacy of adding simvastatin to     the current conventional treatment regimen for the management of pulmonary hypertension.   "
178675|NCT00180726|"     The aim of this study is to investigate the mechanisms whereby lung function is decreased in     asthma and sensitivity to treatment. The hypothesis is that in diseases such as asthma,     inflammatory cells (leukocytes) including eosinophils, macrophages and lymphocytes migrate to     the lung and release either more or different types of inflammatory mediators and/or     receptors compared to subjects without asthma, which are corticoid sensitive or insensitive.     The objective of the study is to identify which genes are specifically expressed in important     cells in patients with asthma with a view to identify novel targets for drug therapy.   "
178676|NCT00180739|"     The study objective is to develop data for the safety of pregnancies after thermal ablation     of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.   "
178677|NCT00180752|"     We wish to study the effect of Chronic Obstructive Pulmonary Disease on the activity of the     nuclear transcription pathway in peripheral skeletal muscle to determine whether altered     activity of this pathway may be responsible for the muscle dysfunction observed in these     patients.   "
178678|NCT00180765|"     Chronic obstructive pulmonary disease (COPD for short) involves inflammation inside the air     passages of the lungs. This inflammation might be partly responsible for the shortness of     breath, cough and susceptibility to chest infections that form part of COPD. Inflammation is     caused, in part, by white blood cells that are attracted from the blood into the air     passages. Once inside the air passages, the white blood cells may change (or 'differentiate')     and release substances that produce inflammation and attract more white cells. The hypothesis     is that the lifespan of these cells may also be prolonged such that they produce more     inflammatory mediators and in turn perpetuate inflammation. The cycle of inflammation may     damage the lungs, so we want to see what mediators are released by white blood cells and     determine if we can inhibit this effect with existing and new drugs. We would also like to     see the effect of these drugs on the life-span and function of white blood cells. We will     compare the behaviour and characteristics of white cells with those from healthy smokers and     healthy non-smokers to find out if there is anything different about cells from COPD     patients.   "
178679|NCT00180778|"     Does the addition of steroids during the first trimester to the standard aspirin + heparin     treatment reduce the miscarriage rates in women with antiphospholipid antibodies and     recurrent first trimester miscarriage in those who had an unsuccessful pregnancy with aspirin     + heparin?   "
178680|NCT00180791|"     The purpose of this study is to evaluate the efficacy of the combination of surgery,     conventional chemotherapy, sequential high-dose chemotherapy with peripheral blood stem cell     transplantation and reduced dose radiation therapy in high-risk PNET brain tumors.   "
178681|NCT00180804|"     For implantation of developing conceptus, placental cells need to invade mother's uterus to     access maternal blood supply in a control manner. We have found a combination of maternal     immune genes (the KIR family) and fetal genes (HLA-C) strongly associated with pre-eclampsia     where placenta does not implant adequately. The aim of this research is to investigate these     two genes family in women suffering with recurrent miscarriages and find a possible link     between them.   "
178682|NCT00180817|"     This study is being done to see if there are any long term health related issues in women     with APA and recurrent miscarriages.   "
178683|NCT00180830|"     The purpose of this study is to determine whether Glivec is effective, in children,     adolescents and young adults, in the treatment of malignant disease in which evidence     suggests a potential pathogenic role of one or more of the tyrosine kinases known to be     inhibited by Glivec.   "
178684|NCT00180843|"     Subjects undergo history, examination, lung function assessment after informed consent has     been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is     normal they will undergo a second and final scan four weeks later. If abnormal they will     undergo two further scans with either nebulized bronchodilator or nebulized saline prior to     their second and third scans. Each time they will have repeat lung function tests prior to     scanning. We will examine the regional changes in ventilation and perfusion and there     relationship to lung function.   "
178741|NCT00181766|"     This is an open-label study with daily doses up to 144 mg/day Strattera (atomoxetine) in the     treatment of adults with attention deficit hyperactivity disorder not otherwise specified.     The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to     Strattera treatment and Strattera treatment (in doses of up to 120 mg/day or 1.5 mg/kg/day,     whichever is less) in adults with ADHD NOS will be safe and well tolerated.   "
178686|NCT00180869|"     There is evidence to suggest that red blood cell concentrate (RBC) transfusion may have     immunomodulatory effects. The aim of this randomized single-center trial is to compare immune     responses in patients undergoing cancer surgery and given either an unmodified RBC (UN-RBC)     or a leuko-reduced RBC (LR-RBC) transfusion perioperatively.   "
178687|NCT00180882|"     To explore in a multicenter international prospective randomized study (phase III) whether     rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate     of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt     lymphoma or ALL 3.   "
178688|NCT00180895|"     This is a multicentric phase II study of Mabthera (rituximab) in children and adolescents     with relapsed and refractory B-cell NHL/L3ALL. The primary objective is to determine the     response rate of Rituximab as single agent in relapsed or refractory Burkitt lymphoma, L3     acute leukemia, large B-cell lymphoma and non subclassified aggressive B-cell NHL   "
178689|NCT00180908|"     The purpose of this study is to compare two preoperative chemotherapy regimens based on     high-dose methotrexate courses given alternately either with doxorubicin or with     etoposide-ifosfamide.   "
178690|NCT00180921|"     This is a Phase II study of imatinib (Glivec) administered as a daily oral treatment in     patients with recurrent/metastatic adenoid cystic carcinoma of the head and neck     overexpressing KIT.   "
178691|NCT00180934|"     Interest of a reirradiation with concomitant chemotherapy after salvage surgery for     recurrence of head and cancer in irradiated area : a multicentric Phase III randomized trial   "
178692|NCT00180947|"     This is a phase II study to determine the antitumor activity of Vinorelbine and     Cyclofosfamide association among patients with refractory tumours or in relapse with     rhabdomyosarcomas and other soft tissue tumours, Ewing tumours, osteosarcomas, neuroblastomas     or medulloblastomas.   "
178693|NCT00180960|"     The purpose of this study is to evaluate the treatment of a cancerous disease of the     peritoneum with complete cytoreductive surgery with intraperitoneal chemohyperthermia using     oxaliplatin plus irinotecan.      This is a Phase II study with 100 patients. Origins of the tumors: these include colon,     rectum, appendix, peritoneum, and endocrine tumors.   "
178694|NCT00180973|"     MULTICENTRIC INTERNATIONAL RANDOMIZED PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY     (BEC REGIMEN) FOLLOWED BY STANDARD RADIOTHERAPY (70 Gy / 7 WEEKS) VERSUS THE SAME NEOADJUVANT     CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE     TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE (UCNT).   "
178695|NCT00180986|"     Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In     Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child   "
178696|NCT00180999|"     Randomised study to compare the effect of r-Hu-EPO administration with transfusion of Red     Blood cell concentrates and also with the administration of polyvitamins in anemic and tired     patients presenting a bad prognostic in middle course.   "
178697|NCT00181012|"     This study will evaluate the benefit of lidocaine perfusion in cancer related visceral pain     resistant to morphinics. It is an efficacy study in adults and children and a randomized     prospective study.   "
178698|NCT00181025|"     This study looks at isolated pelvic perfusion and limbs' girdle with 1 mg tumor necrosis     factor alpha (TNFa) in the treatment of locally advanced sarcoma of the pelvis and limbs’     girdle.   "
178699|NCT00181038|"     This trial examines the analgesia of the fibula free flap donor site by peri-neuronal     catheter in oro-pharyngeal carcinoma surgery by comparing continuous infusion of a local     anesthetic with systemic multimodal analgesia.   "
178700|NCT00181051|"     Index computed in real time from Auditory Evoked Potentials have been described parallel to     depth of anesthesia. The goal of the study was to compare general anesthesia guided on     Auditory Evoked Potentials monitoring to standrad practice in order to assess if AEP     monitoring can improve recovery delay (main criteria) or intraoperative hemodynamic stability     (secondary criteria). Patients were randomized in 2 groups, stratified by center. Group I :     AEP guided anesthesia, Group II: Blind AEP record, standard practice.   "
178701|NCT00181064|"     This is a 3-month pilot study of 10 adolescents with chronic daily headache. Teens will be     placed on a modified Atkins diet and followed with 2 subsequent visits to assess for headache     improvement.   "
178702|NCT00181077|"     To compare hypertonic saline to Lactated Ringer's solution and assess whether one speeds up     the process of getting rid of extra body water faster in women with preeclampsia.   "
178703|NCT00181090|"     This study is designed to further investigate the use of a modified Atkins diet for children     with intractable, daily seizures. It is a follow-up to a study recently completed by our     institution. In this 6-month study, children will be randomized to either 10 or 20 grams of     carbohydrate per day, then crossed over to the opposite amount at 3 months.   "
178704|NCT00181116|"     This study is designed to test if the language problems commonly seen in children with benign     rolandic epilepsy would improve by switching anticonvulsants to levetiracetam.   "
178705|NCT00181129|"     The purpose of this randomized controlled trial is to determine the effects of a     nurse-directed, home-based walking exercise program to mitigate fatigue and maintain physical     functioning during adjuvant therapy for cancer. The sample will be randomized into exercise     (EX) or usual care (UC) groups. The independent study variable is participation in a walking     exercise program. Outcomes include: fatigue, sleep disturbance, emotional distress, physical     functioning and quality of life. The effects of the walking exercise program will be     evaluated using self-report questionnaires administered pre- and post-treatment, patient     diaries, and symptoms assessments at defined intervals during adjuvant therapy   "
187638|NCT00302666|"     The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy     and safety of this oral contraceptive in two different regimens of intake.   "
178708|NCT00181168|"     The purpose of this study is to determine [for patients with previously treated     well-differentiated thyroid cancer and evidence of residual disease based on serum     thyroglobulin (Tg) level] whether positron emission tomography-computed tomography (PET-CT)     fusion scanning performed after recombinant TSH (rTSH, thyrotropin alfa for injection) will     be more sensitive for the detection of disease sites than PET-CT scanning without rTSH. The     study will also determine if this information will significantly alter the therapeutic     approach in some patients.   "
178709|NCT00181181|"     This research is being done to find if treatment with atorvastatin, a drug that reduces     cholesterol, improves the function of blood vessels among people with high blood pressure.     Adults with mildly high blood pressure, or who are taking medication for high blood pressure     but are otherwise healthy may join, with the approval of their health care provider. The     study period is 14-17 weeks. Approximately 50 to 60 subjects will take part in the study.   "
178710|NCT00181194|"     The purpose of this study will be to assess the impact of a culturally-sensitive,     patient-focused asthma communication instrument (ACCI) designed to enhance provider-patient     communication by prompting and guiding providers in assessments of disease severity and     discussion of adherence behaviors with minority patients with asthma.   "
178711|NCT00181207|"     The purpose of this study is to show that one form of mechanical airway clearance techniques,     High Frequency Chest Wall Oscillation (HFCWO)using a pneumatic vest, will diminish     exacerbations of COPD which will improve respiratory health status.   "
178712|NCT00181220|"     The proposed study will test the safety and efficacy of sodium valproate in the induction of     Epstein-Barr virus (EBV) lytic cycle antigen expression in tumor tissue of patients     undergoing primary therapy for nasopharyngeal carcinoma. Up to 20 patients will be given     valproic acid for 2 weeks. The primary surrogate endpoint for efficacy will be expression of     EBV lytic antigens by immunohistochemistry in tumor tissue. Biopsies of primary tumor will be     taken after 2 weeks with achievement of a therapeutic concentration of valproate. Expression     of immunodominant EBV latency antigens in tumor tissue, EBV viral load by real time PCR, and     valproate levels will be measured. Adverse events associated with valproate in NPC patients     will be described.   "
178713|NCT00181233|"     Sudden cardiac death is a tragic event that strikes all age groups and is unfortunately     increasing in prevalence. Because it is difficult to predict those at highest risk, this     study is designed to test the hypothesis that new imaging techniques (magnetic resonance     imaging [MRI] and computed tomography [CT]) are useful for identifying factors which put     people at high risk for sudden death.   "
178714|NCT00181246|"     The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established,     although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has     been shown to be effective for treating other types of pain. We propose to measure functional     outcomes, pain relief and side effects of fentanyl TTS for the treatment of neuropathic pain.     Measures will be made at baseline and after titrating the drug to an effective level.   "
178715|NCT00181259|"     The metabolism of the heart provides the chemical energy needed to fuel ongoing normal heart     contraction. Magnetic resonance spectroscopy is a technique used in a MRI scanner that can be     used to measure and study heart metabolism directly but without blood sampling or obtaining     tissue biopsies. One of the hypotheses this study aims to investigate is whether energy     metabolism is reduced in heart failure and whether that contributes to the poor heart     function.   "
178716|NCT00181272|"     The purpose of this study is to determine whether macrolide therapy is effective in treating     patients hospitalized with asthma exacerbations or chronic obstructive pulmonary disease     (COPD)exacerbations. We hypothesize that compared to placebo, maintenance therapy with     macrolides, when added to usual care, a) improves respiratory symptoms, b) improves quality     of life, c) reduces airway inflammation, d) reduces airflow obstruction, and e) decreases the     rate of re-exacerbations.   "
178717|NCT00181285|"     The purpose of this study is to determine whether inpatient use of a high frequency chest     wall oscillator is an effective therapy for patients hospitalized with asthma exacerbations     or chronic obstructive pulmonary disease (COPD) exacerbations.      The investigators hypothesize that inpatient use of HFCWO will promote clearance of airway     secretions, leading to more rapid resolution of severe asthma and COPD exacerbations and     lower rates of re-exacerbations after hospital discharge.   "
178718|NCT00181298|"     Neuropsychiatric manifestations of Systemic Lupus Erythematosus (NPSLE) are both common and     an important source of morbidity. Of the case definitions for NPSLE syndromes that have     recently been developed, cognitive dysfunction appears to be the most prevalent. A novel     mechanism is that a subset of SLE patients with cognitive dysfunction have antibodies in the     NR2 glutamate receptor. We propose, in a double -blind placebo-controlled trial, to determine     whether SLE patients, with or without the NR2 glutamate receptor antibody, have significant     improvement using memantine, an inhibitor of the NMDA receptor.   "
178719|NCT00181311|"     The purpose of this study is to evaluate the short and long term complications after an     abdominal or vaginal hysterectomy and to detect the prevalence of occult/subclinical     haematomas and vaginal cuff abscesses and the postoperative course of these.      The investigators will also evaluate the physical and mental well being after a hysterectomy     with a questionnaire and correlate these results with the occurrence of complications.   "
178720|NCT00181350|"     This study aims at providing a quantitative evaluation of the accuracy of two different     fixation systems, where one system is also evaluated with two different set-ups.   "
178721|NCT00181363|"     We hypothesize that for large pendulous breasts, breast irradiation in supine and prone     position are equivalent with regard to coverage of the PTV, but with a better dose     homogeneity in prone position and a smaller radiation exposure of lung and heart.The purpose     of this study is to compare the 3-D dose distribution in PTV and normal tissues in prone     position versus supine position.   "
178722|NCT00181506|"     In this study we try to increase the radiation dose, while reducing or keeping the radiation     schedule below 4 weeks.      The study hypothesis is that it is feasible to administer hyperfractionated accelerated     radiotherapy to patients with inoperable or locally advanced non small cell lung cancer.   "
178846|NCT00183157|"     The purpose of the study is to determine if a brief motivational interview in the context of     an emergency health care visit will reduce high-risk drinking and drug-taking and associated     health consequences among adolescents ages 14-21 years old.   "
178724|NCT00181545|"     Radiotherapy is treatment of choice for inoperable lung cancer. Research has shown that the     local control rate is low and the radiation often causes pneumonitis and/or esophagitis.      To predict to lung damage the mean lung dose can be calculated. This allows us to give a     higher total dose to the tumor and to improve the local control rate.      Study hypothesis: It will be safe to administer a radiation dose as high as possible to the     tumor, taking into account the mean lung dose, calculated by the treatment planning system.   "
178725|NCT00181558|"     The main purpose of this study is to look at the effects (good or bad) that Atrasentan given     alone and Atrasentan given with Zometa has on levels of bone formation and bone destruction     in men with prostate cancer that has spread to the bones.   "
178726|NCT00181571|"     This is a double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of     Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit     hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults     with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of     ADHD symptomatology in adults will be sustained over time.   "
178727|NCT00181584|"     The primary objective of this study is to determine whether zoledronic acid (Zometa) given     once annually increases bone mineral density in men receiving hormone therapy for prostate     cancer.   "
178728|NCT00181597|"     The main purpose of this study is to test the safety of trilostane by looking at what     effects, good and bad, it has on patients with androgen-independent prostate cancer.   "
178729|NCT00181610|"     The purpose of the study is to assess the safety and determine the effects of the hormone     prolactin on lactation (breast milk production).   "
178730|NCT00181623|"     The purpose of the study is to assess the safety and determine the effects of the hormone     prolactin on lactation (breast milk production).   "
178731|NCT00181636|"     The purpose of the study is to determine whether the investigational drug galantamine-CR     (Reminyl- Controlled Release capsule) is useful in improving problems with memory in bipolar     patients with stable mood. This study is being done because a large proportion of patients     with bipolar disorder experience significant memory problems, even when their mood is stable,     after adequate treatment. These memory problems have been associated with poor daily social     functioning. Studying galantamine-CR in this population may provide a new clinical way to     combat memory problems in stable patients with bipolar disorder.   "
178732|NCT00181649|"     The purpose of the study is to assess the safety and determine the effects of the hormone     prolactin on lactation (breast milk production).   "
178733|NCT00181662|"     This study looks to describe the pharmacokinetics of curcumin delivered as a single oral dose     in healthy female volunteers. The impact of piperine and silybin on the pharmacokinetics of     curcumin is also studied.   "
178734|NCT00181675|"     This will be a double-blind, placebo-controlled, study using daily doses of up to 24 mg/ day     Galantamine HBr in the treatment of adults who meet DSM-IV criteria for childhood-onset ADHD.     Specific hypotheses are as follows:      Hypothesis 1: ADHD symptomatology in adults with DSM-IV ADHD will be responsive to acute     Galantamine HBr treatment.      Hypothesis 2: Galantamine HBr -associated improvement in ADHD symptomatology in adults will     translate into improved functional capacities (neuropsychological, social, and occupational)     as well as an increased quality of life throughout acute treatment.      Hypothesis 3: Galantamine HBr treatment will be safe and well tolerated as reflected by a low     drop out rate and absence of major differences from placebo.   "
178735|NCT00181688|"     The main purpose of this study is to determine the effects (good and bad) Iressa plus     anastrozole has on patients with relapsed ovarian cancer.   "
178736|NCT00181701|"     The main purpose of this study is to determine the safety and tolerability of giving both     paclitaxel and carboplatin in the abdominal cavity by looking at what effects (good and bad)     this route of administration has on patients with ovarian cancer. Standard chemotherapy drugs     are administered intravenously but a number of trials have shown that injecting drugs into     the abdominal cavity, or intraperitoneally, have shown promising results.   "
178737|NCT00181714|"     This study will consist of a six-week open-label treatment period with an extended duration     methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large     sample of youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders,     Fourth Edition (DSM-IV) criteria for ADHD.      The researchers hypothesize that OROS MPH treatment will be associated with low rates of     cigarette smoking in ADHD youth.   "
178738|NCT00181727|"     This is an open-labeled study of Divalproex Sodium Extended Release (Depakote ER), testing     its efficacy for the treatment of mania in children between the ages of 6-12 who have been     diagnosed with Bipolar I, Bipolar II, and Bipolar Spectrum Disorders. This is an exploratory,     pilot study, seeking to determine whether Divalproex Sodium Extended Release is efficacious     and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum     disorder, and the study results will be used to generate hypotheses for a larger randomized     controlled clinical trial with explicit hypotheses and sufficient statistical power.   "
178739|NCT00181740|"     This will be an open label pilot study of Concerta in the treatment of adults with the     diagnosis of Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS). We     hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Concerta     treatment in the short term and Concerta-associated response of ADHD symptomatology in adults     with ADHD NOS will be sustained over the medium term.   "
178740|NCT00181753|"     The purpose of the study is to understand how the body uses amino acids in burned patients     during the time they cannot eat normally. Amino acids occur naturally in the body and the     food we eat. The body combines amino acids to make protein. It uses the proteins to do things     such as heal wounds, fight infection, and provide energy. We are studying two ways of     receiving nutrition: through a vein or through a tube. We are also studying two different     types of food: with or without glutamine. The results of this study will be used to determine     the best type and way to supply nutrients during a severe burn injury. We hope to learn how     to help the body use nutrients more efficiently to better repair wounded tissues and recover     earlier from injury.   "
178892|NCT00171262|"     To analyze efficacy of fluvastatin on patients with chronic renal disease by analyzing     certain inflammatory markers. In addition, tolerability and safety will also be evaluated in     a Spanish population.   "
178742|NCT00181779|"     This is an open-labeled study of Aripiprazole, testing its efficacy in the treatment of mania     in children and adolescents with Bipolar I, Bipolar II and Bipolar Spectrum Disorder over 8     weeks. This is an exploratory, pilot study, seeking to determine whether Aripiprazole is     efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar     spectrum disorder. The study results will be used to generate hypotheses for a larger     randomized controlled clinical trial with explicit hypotheses and sufficient statistical     power.   "
178743|NCT00181792|"     The researchers will study 100 families over three years, each with a child (proband) between     the ages of 12-17, with the Diagnostic and Statistical Manual of Mental Disorders, Fourth     Edition (DSM-IV) diagnosis of ADHD. The researchers hypothesize smoking will be familial and     ADHD probands with a family history of tobacco use will be at increased risk for early     initiation and persistence of smoking, compared to ADHD probands with no family history of     tobacco use.   "
178744|NCT00181805|"     The goal of this project is to determine the long-term health outcome of children diagnosed     with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in     the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have     compiled a database of more than 300 subjects that completed diagnostic testing for GER in     the 1970's, 1980's, and 1990's. Subjects are being contacted initially by mail using a     previously approved recruitment letter. Subjects that fail to respond to this recruitment     letter are called by phone. In each case, contact information has been abstracted from the     Children's Hospital database. Subjects are then given the opportunity to complete a     questionnaire either by phone or in hard copy. Subjects receive no compensation for their     participation in this study. Subjects will be compared to controls. Controls will complete     the same questionnaire as the subjects. Inclusion of potential controls will be determined by     a lack of medical history of gastroenterological diseases before the age of 21 and whether     the potential control was born within a year of a subject in the study. Controls will receive     $25 to participate in the study.   "
178745|NCT00181818|"     The purpose of the study is to test the efficacy and safety of bupropion SR for smokers     hospitalized with acute cardiovascular disease.   "
178746|NCT00181831|"     The primary aim of this study is to use proton magnetic resonance spectroscopy to look at     myo-Inositol containing compounds (Ino) and creatine + phosphocreatine (Cr) in the anterior     cingulate of 20 children with bipolar disorder between the ages of 6-17 years old free of     risperidone treatment and 20 children with bipolar disorder after an eight-week or longer     treatment with risperidone. For comparison, results will also be obtained from 20 controls     (without bipolar disorder or ADHD) of the same age and gender as well as from 20 children or     adolescents with a diagnosis of Attention Deficit Hyperactivity Disorder. We hypothesize that     Ino/Cr levels in the anterior cingulate will correlate positively with manic symptoms using     the Young mania rating scale (YMRS). Ino/Cr levels in the anterior cingulate in the anterior     cingular gyrus will be lower in subjects who have received eight weeks or longer of     risperidone   "
178747|NCT00181844|"     The main objective of this study is to assess the effectiveness and safety of lamotrigine in     the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory,     12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV     diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study     results will be used to generate hypotheses for a larger randomized controlled clinical     trial. Based on the available literature in adults with bipolar disorder, we hypothesized     that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and     bipolar spectrum disorders.   "
178748|NCT00181857|"     The researchers plan to explore the validity of the category of ADHD NOS by identifying the     risk for ADHD in the children of ADHD NOS adult probands and identifying common correlates of     ADHD in these children. The researchers hypothesize that the rate of ADHD will be higher in     the children of the ADHD NOS probands than the rate of ADHD previously published for siblings     of proband children with ADHD; and ADHD children of ADHD NOS adults will have higher rates of     school failure (as measured by their rate of repeated grades, need for tutoring, and     placement in special classes) than their non-ADHD siblings.   "
178749|NCT00181870|"     This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the     treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum     Disorder. The main goal of this study is to begin to address the void of information on     safety, tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar     Disorder.   "
178750|NCT00181883|"     This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of     Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar     spectrum disorder. This is an exploratory, pilot study, seeking to determine whether     Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric     bipolar and bipolar spectrum disorder in this age group. The study results will be used to     generate hypotheses for a larger randomized controlled clinical trial with explicit     hypotheses and sufficient statistical power.   "
178751|NCT00181896|"     This is an 8-week open label study of bupropion SR in the treatment of youth with bipolar     depression with adequate mood stabilization. All youth will be closely monitored for     treatment emergent manic activation and drug-drug interactions with ongoing antimanic agents.      The main objective of this study is to assess the safety and effectiveness of bupropion SR in     the treatment of bipolar depression in children and adolescents.   "
178752|NCT00181909|"     The principal objective is to test whether offering pregnant smokers a proactive telephone     counseling program throughout pregnancy and for 2 months postpartum increases the rate of     smoking cessation at end of pregnancy and 3 months postpartum, compared to a “best practice”     control condition.   "
178753|NCT00181922|"     The objective of this study is to compare the safety and effectiveness of Ziprasidone in the     treatment of mania in children and adolescents with Bipolar disorder over 8 weeks. This is an     exploratory, open-label study, which seeks to determine if there is evidence for efficacy.     The results of this study will be used to generate hypotheses for a larger study.   "
178893|NCT00171275|"     This study is to evaluate the safety and efficacy of fluvastatin versus placebo, dosed     shortly after or immediately when the coronary event occurs.   "
178755|NCT00181948|"     This will be a 6-week, unblinded study using the medication Strattera for children and     adolescents with attention deficit hyperactivity disorder (ADHD) who failed to respond to an     adequate trial of stimulant treatment. Specific hypotheses are as follows:      Hypothesis 1: ADHD symptomatology in youth with ADHD will be responsive to Strattera     treatment in the short term.      Hypothesis 2: Strattera treatment (in doses of up to 120 mg/day or 1.2 mg/kg/day) in children     and adolescents with ADHD will be safe and well tolerated.   "
178756|NCT00181961|"     The purpose of this study is to determine the dose of Maca Root effective for the treatment     of antidepressant-induced sexual dysfunction in patients with DSM-IV defined Major Depressive     Disorder. We propose to carry out a dose-finding pilot study to determine the minimum     effective dose of Maca Root. We hypothesize that patients who receive Maca Root will     experience alleviation of their sexual dysfunction, and this effect will be more pronounced     in those who receive higher doses of maca root.   "
178757|NCT00181974|"     The purpose of this study is to determine the effectiveness of a fibrin glue in burn surgery     with respect to hemostasis and skin graft fixation.   "
178758|NCT00181987|"     The objective of this study is to investigate the safety and effectiveness of Concerta in the     treatment of children (ages 5 to 17 years old) and adults (ages 18 to 55 years old) with     Bipolar I, Bipolar II and Bipolar Spectrum Disorder and comorbid ADHD over 8 weeks. This     study seeks to study the short-term effectiveness of a long acting formulation of     methylphenidate (Concerta) in the treatment of children and adults with bipolar disorder and     comorbid ADHD adequately stabilized on an acceptable and stable regimen of anti-mania agents.   "
178759|NCT00182000|"     This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the     positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).   "
178760|NCT00182013|"     The objective of this study is to compare the safety and effectiveness of Risperidone,     Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar     disorder over 8 weeks and then over an extension phase. This is an exploratory, open-label     study, which seeks to determine if there is evidence for efficacy. The results of this study     will be used to generate hypotheses for a larger study.   "
178761|NCT00182026|"     The purpose of this study is to test whether providing personalized diabetes self-management     recommendations and feedback improves blood sugar control more than providing generalized     diabetes educational material alone.   "
178762|NCT00182039|"     This trial will evaluate the ability of metoprolol (a beta-blocker drug) to prevent heart     attacks and deaths around the time of surgery.   "
178763|NCT00182052|"     The purpose of this study it to learn the effects (good or bad) that rosiglitazone has on     patients and their prostate cancer. This study is going to look at what effects rosiglitazone     has on prostate specific antigen (PSA) levels.   "
178764|NCT00182065|"     Heart failure is very common in the elderly, in whom it may lead to functional and     intellectual problems. Functional problems include loss in the ability to perform basic tasks     of daily living such as bathing or dressing. No studies have yet described the rate at which     heart failure causes these problems to develop. This study aims to find out whether nursing     home patients deteriorate more quickly with respect to function and intellect if they have     heart failure. Participants will undergo a thorough health history and physical examination     and will be followed every 3 months for up to a year. Over 30 nursing homes in Kitchener,     Waterloo, Cambridge, and Hamilton, in South Central Ontario (Canada), are participating in     this study. Every 3 months, participants will be reviewed with respect to function,     intellect, mood and behaviours. Results between those with heart failure will be compared to     those of people without heart failure. The results of this study will be used to plan further     studies to see whether good treatment of heart failure can preserve function, intellect, and     prevent depression and other mood problems.   "
178765|NCT00182078|"     The broad, long-term objectives of this proposal are to prevent the emergence of     posttraumatic stress and depressive symptoms in children admitted for an acute burn,     reconstructive surgery, or non-burn injury. This study is investigating the early use of a     medication in the prevention of posttraumatic stress disorder and depression. Specific Aims 1     and 2: To assess the efficacy of sertraline to prevent the development of (Aim     1)posttraumatic stress disorder and (Aim 2)depression in children aged 6-20, after burn or     non-burn injury or after reconstructive surgery. Hypotheses 1 and 2: Administration of     sertraline after an acute burn or non-burn injury, or after reconstructive surgery will lead     to greater reduction in post-traumatic and depressive symptoms over 12 and 24 weeks, compared     with placebo.      This study is completing the evaluation of 90 children and adolescents, aged 6-20 years. It     is comparing 60 subjects receiving sertraline with 30 placebo control subjects matched for     age, severity of injury, and type of hospitalization (acute vs. reconstructive). Children and     families are evaluated for the presence of acute stress symptoms. Children are reassessed in     a double-blind placebo-controlled design, with evaluations at Baseline, Week 2, Week 4, Week     8, Week 12, and Week 24. In addition, there is weekly monitoring for the first 14 weeks of     the study and again at 18 weeks (the midpoint of the study). At each reassessment,     information is collected on the child's compliance with the study medication, the parents'     assessment of the child's functioning, and the child's self-report of posttraumatic and     depressive symptomatology. The main outcome variable used in this study is the child's     posttraumatic symptoms.   "
178783|NCT00182312|"     At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams     at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting     disabilities. The aim of this research is to reduce this heavy burden of illness. A     multi-center randomized controlled trial has been designed in which 2000 very low birth     weight infants will be enrolled. Our goal is to determine whether the avoidance of     methylxanthine drugs will improve survival without disability to 18 months, corrected for     prematurity.      Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and     breath-holding spells in premature infants. However, there is a striking lack of evidence for     the long-term efficacy and safety of this therapy. Methylxanthines block a naturally     occurring substance, called adenosine, which protects the brain during episodes of oxygen     deficiency. Such episodes are common in infants who are treated with methylxanthines. It is     possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this     trial will clarify whether methylxanthines cause more good than harm in very low birth weight     infants.   "
178895|NCT00171301|"     To allow patients treated with deferasirox in the core study to continue iron chelation     therapy for 2 years or until the drug became locally commercially available. To evaluate the     long-term safety and efficacy of deferasirox by measuring treatment success, change in liver     iron content (LIC) and change in serum ferritin levels. Safety was mainly assessed by     incidence of adverse events (AEs)and clinically significant lab parameters.   "
178766|NCT00182091|"     The purpose of the study is to evaluate the effects of growth hormone (GH) replacement in men     and women with a history of acromegaly and who are now growth hormone deficient. We will     compare them to persons with a history of acromegaly who have normal GH levels.      Acromegaly results when an area in the brain, called the pituitary, produces too much growth     hormone. When an individual is cured of acromegaly, the growth hormone levels may be normal     or low (that is GH deficiency). Growth hormone deficiency means the body no longer produces     as much growth hormone because the pituitary/hypothalamic region was damaged by a tumor or by     treatment received.      We will study the effects of growth hormone replacement on the health of the heart and blood     vessels of GH deficient persons by looking to see if this therapy:        1. has effects on cardiovascular risk markers (special blood tests which indicate how          healthy your heart and arteries are)        2. affects the stiffness of the arteries        3. affects your heart rate and the capacity of your heart to respond to changes in body          position        4. has different effects depending on whether you are taking estrogen / testosterone.      We will assess these measures of health on one occasion in persons with cured acromegaly and     normal GH levels and in persons with cured acromegaly who have GH deficiency and a     contraindication to receiving GH. GH deficient individuals with no contraindication to     receiving GH, will participate in the study for 12 months. Individuals with normal GH levels,     or who are GH deficient and have a contraindication to receiving GH, will be asked to return     for one more visit (without any interventions).   "
178767|NCT00182104|"     Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years     following Fontan procedures.   "
178768|NCT00182117|"     This study is examining the risk and protective factors associated with bleeding in the     hemodialysis population.   "
178769|NCT00182130|"     The Quality initiative in rectal cancer (QIRC) trial will test if a strategy designed to     positively influence surgeon practice can decrease hospital rates of permanent colostomy and     local tumour recurrence for surgically treated rectal cancer patients.   "
178770|NCT00182143|"     The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH)     (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal     leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary     outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and     objectively confirmed venous thrombosis at any site.   "
178771|NCT00182156|"     This study is examining the effects of short daily hemodialysis on platelet function, fluid     volume control, arterial stiffness and patient quality of life, as compared to conventional     hemodialysis.   "
178772|NCT00182169|"     Prospective randomized, placebo controlled, clinical trial to evaluate the effect of human     growth hormone supplementation compared with placebo to patients with severe heart failure     for a duration of 6 months on exercise capacity, heart function and quality of life   "
178773|NCT00182182|"     Evaluation of a primary care based (family physicians) HF management strategy in patients     with heart failure in the community   "
178774|NCT00182195|"     A multinational, randomized trial comparing two lung protecting strategies of respiratory     life support among critically ill patients with severe lung injury.   "
178775|NCT00182208|"     The purpose of this study is to determine whether daily use of a lower limb venous-return     assist device, Venowave', improves leg symptoms, ability to perform activities of daily     living, and quality of life in subjects with severe PTS.   "
178776|NCT00182221|"     To determine whether D-Dimer testing, using the MDA D-Dimer assay, can be used to simplify     the diagnostic process for pulmonary embolism (PE). This will be assessed by performing a     cohort study in 1000 patients with suspected PE.      To ascertain if an MDA D-Dimer result of less than 0.75 ug/mL FEU obviates the need for     further testing and therapy in patients with suspected PE.   "
178777|NCT00182234|"     This research project will address the issue of gaps in continuity of supportive care for     cancer patients during the early phases of the disease trajectory that result in unmet needs     and unnecessary morbidity. The investigators intend to study the impact of a specialized     cancer-nursing program, Interlink Community Cancer Nurses (Interlink) on patient outcomes.     Impact will be assessed directly using a validated measure of continuity of care from the     patients' perspective and validated measures of key supportive care patient outcomes     including unmet needs, distress, uncertainty in illness, and quality of life, in a randomized     trial.   "
178778|NCT00182247|"     To simplify and improve the diagnostic approach to patients with clinically suspected     recurrent DVT by determining whether the results of the combination of IPG and d-dimer     testing, using a whole blood agglutination assay, can be used in the management of such     patients.   "
178779|NCT00182260|"     LNF is an effective intervention in the management of patients with chronic GERD requiring     maintenance therapy. LNF is cost-effective compared with long-term medical therapy.      LNF is more effective than maximum medical therapy in control of respiratory symptoms and     complications of GERD.   "
178780|NCT00182273|"     The purpose of this study is to see whether family doctors can treat benign paroxysmal     positional vertigo (BPPV), or dizziness, using a procedure in the office. The study is     looking at whether the treatment procedure cures the dizziness in more patients compared to     patients that receive a sham or placebo procedure.   "
178781|NCT00182286|"     This project was conducted with patients at a multi-disciplinary, multi-specialty health     services organization serving 44,000 rostered patients in Northern Ontario. It investigated     continuity of care for patients with diabetes in the areas of barriers and potential     solutions to, and correlates of continuity; and variability in costs associated with     continuity of care and patient outcomes.   "
178782|NCT00182299|"     The prognosis for patients with large rotator cuff tears is poor. This recently developed     biologic scaffold provides numerous structural and functional properties that may direct cell     growth and aid in tendon healing. To date, there are no randomized clinical trials assessing     the effectiveness of the patch to augment repairs of large rotator cuff tears. We propose a     study to compare the rate of repair failure, quality of life, function, pain, and range of     motion in 60 patients with large rotator cuff. Patients will be randomized (like flipping a     coin) to undergo a standard rotator cuff repair with or without augmentation with SIS.     Patients are assessed at 6 weeks, 3, 6, 12, 18, and 24 months post-operative   "
178784|NCT00182325|"     Many women are turning to the Internet to meet their health information needs, but the large     amount of information available, as well as the unknown reliability and applicability of     information can be overwhelming. Studies in specific patient populations have determined that     patients given access to personalized, on-line medical information are more satisfied with     their care than patients provided generalized information. None of these studies have looked     at whether this type of patient education would be helpful for pregnant women. This study is     being done to determine whether pregnant women who have access to their own health records     and personalized health information over the Internet are more satisfied with their prenatal     care, and if they are more compliant with health visits and tests, compared to pregnant women     who receive only generic pregnancy information on the Internet and from pamphlets   "
178785|NCT00182338|"     Patients with kidney failure on dialysis have a much higher risk of developing cardiovascular     disease as compared to the general population. Recently, two large studies have shown that     increasing the amount of dialysis does not decrease cardiovascular disease. It is known that     retaining too much fluid leads to high blood pressure and thickening of the heart wall.     Peritoneal dialysis is a method of home dialysis which allows dialysis patients autonomy and     independence. This study will measure blood levels of a protein called N-BNP and measure the     extent of body fluid by a machine called a bioimpedance analyzer. This device administers an     undetectible electric current which distributes throughout total body water. The relationship     between these tests and the clinical presence of volume expansion will be assessed. In     addition, the extent of total body fluid and it's impact on heart attacks, heart failure and     stroke will be determined.   "
178786|NCT00182351|"     To determine whether d-dimer testing can be used to simplify and reduce the costs of the     diagnostic approach to patients with clinically suspected deep vein thrombosis   "
178787|NCT00182364|"     PROTECT Pilot objective is to assess: 1) the feasibility of timely enrollment and complete,     blinded study drug administration, 2) the bioaccumulation of LMWH in patients with acquired     renal insufficiency and its association with bleeding, 3) the feasibility of scheduled twice     weekly lower limb ultrasounds, and 4) recruitment rates for a future randomized trial.   "
178788|NCT00182377|"     Patients undergoing cardiac surgery with cardiopulmonary bypass require significant fluid     administration. Fluids are used routinely to replace blood lost during and after surgery.     Significant amounts of fluid are also used to prime the tubing and components of the     cardiopulmonary bypass pump before and during its use. The use of Pentaspan - a synthetic     pentastarch - was started because of the restriction of use for blood and blood products,     particularly albumin. Pentaspan is usually used after surgery in the Intensive Care Unit     (ICU). The impact of the use of pentastarch on coagulation, fluid balance and bleeding are     very limited. This study will methodically evaluate the impact of using increasingly greater     amounts of pentastarch during surgery on an open heart surgery patient's recovery in     particular - is there more bleeding, does his/her blood clot as well, and how much fluid     overall is used and excreted?   "
178789|NCT00182390|"     Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight     (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined     as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular     leukomalacia/ventriculomegaly).      Primary Objective: To determine whether either a liberal or more restrictive threshold of     hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either     a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.      Follow-up at a corrected age of 18 months represents a conventional age at which to first     assess neurodevelopmental outcomes, and to predict long-term outcomes.   "
178790|NCT00182403|"     FIDO was a multicentred randomized, open-label trial that compared fixed-dose UFH with     fixed-dose LMWH for initial treatment of VTE. Patients were followed for 3 months during     which they received warfarin (target INR 2.0-3.0).   "
178791|NCT00182416|"     Pacemaker therapy has been recognized as effective for the control of sinus and     atrio-ventricular (AV) node dysfunction. Single chamber pacing when compared with dual     chamber pacing, has numerous advantages of low complication rates, lower cost, better     longevity, with non-inferiority in the quality of life and hard outcomes proven in direct     randomized comparisons. However, comparison between single and dual chamber pacers was never     adequate, since not more then half of the patients in the trials were actually using     pacemakers for the majority of the time. Routine dual chamber pacing using a right ventricle     apical lead is also associated with significant increase in peri-operative and remote     complications. Some of these complications may be related to ventricular desynchronization     secondary to the pacing location, which is potentially avoidable by using biventricular     pacing. A randomized trial which will compare single chamber rate responsive pacing to the     best available modification of dual chamber pacing (biventricular pacing) in suitable     patients is therefore warranted.   "
178792|NCT00182429|"     What is the difference between the use of one drug (Oral Metronidazole) versus the use of     this same drug combined with another drug (Rifampin) in treatment of bacteria and     infection-associated diarrhea in patients? This infection is an important cause of morbidity     and mortality in both the community and hospitals, and the leading cause of hospital and     chronic facility-acquired diarrhea. Research is important for the treatment of this     infection. Patient care with use of two medication treatment regimens will be studied.   "
178793|NCT00182442|"     People affected by schizophrenia often experience poor concentration, lapses in memory and     difficulty with completing tasks; and this set of problems are known as neuro-cognitive     deficits. Traditional medications used in the treatment of schizophrenia have not been     particularly useful in improving these problems, while the recently introduced medications     are expected to be superior in this respect. The proposed research study is designed to     assess the effect of two of the new medications (Zyprexa and Seroquel) in improving the     neurocognitive deficits associated with schizophrenia.   "
178794|NCT00182455|"     SSRI's are considered first-line treatments for GSP, however many patients continue to have     significant symptoms despite an adequate trial of an SSRI. Topiramate, a drug, which targets     the glutamate system in the brain, has been shown to improve symptoms of social phobia when     used on its own and has also been used as an additive treatment in other anxiety disorders.     This study will test the efficacy of adding topiramate to a subject's current SSRI in cases     of GSP which are considered to be treatment-resistant.   "
178795|NCT00182468|"     The purpose of the research is to evaluate whether routine screening for woman abuse in     health care settings, as compared to no screening, does more good than harm. Recent reviews     have identified the need for high quality research to understand 1) the actual impact on all     women of instituting mass screening procedures to identify woman abuse and 2) the extent to     which early identification through screening is effective in preventing or ameliorating     important outcomes. The main outcomes for the study are reduction in violence, improvement in     life quality, and potential harms of screening. A number of secondary outcomes to help     understand the process by which screening and usual care might lead to changes in the primary     outcomes will also be assessed.   "
178796|NCT00182481|"     The purpose of this study was to determine whether the use of induced sputum cell counts     could guide treatment of asthma more effectively than the use of symptoms and breathing     tests. The main outcomes where the time to the first exacerbation and the number of     exacerbations.   "
178797|NCT00182494|"     Diabetes is 2-5 times more common in schizophrenia and it is a preventable; but the current     diabetes prevention guidelines are not suitable for implementation in the severely mentally     ill population. The principles of diabetes prevention are essentially dietary regulation,     increased physical activity and adjunctive use of oral anti-diabetic drugs (metformin). In a     modified diabetes prevention protocol suitable for use in mentally ill population, we     packaged the original guide lines with an adventure and recreation program based on     principles of experiential learning, cognitive restructuring and behaviour modification. In     this proposed study, we plan to evaluate the feasibility of adopting the new protocol, and     examine its effectiveness in preventing diabetes.   "
178798|NCT00182507|"     Trichotillomania (TTM) or hair-pulling has been considered as part of the obsessive     compulsive disorder (OCD) spectrum, although treatment with OCD medications has largely been     unsuccessful. Tics/Tourrettes’ Syndrome (TS) is a disorder, which appears to be related to     TTM, but is treated with a different class of medications than used in OCD, namely     antipsychotics such as olanzapine. This is a study of the safety and efficacy of olanzapine     in the treatment of hair pulling.   "
178799|NCT00182520|"     SRI's are considered first-line treatments for OCD, however many patients continue to have     significant symptoms despite an adequate trial of an SRI. Neuroimaging studies have shown     that the glutamate neurological system is involved in OCD. This study will test the safety     and efficacy of topiramate, a drug, which targets glutamate, in the treatment of OCD, where     the OCD has been un-responsive, or partially responsive to regular SRI treatment.   "
178800|NCT00182533|"     Selective serotonin reuptake inhibitors (SSRIs) including sertraline have been found to be     effective in the treatment of generalized social phobia (GSP). However, virtually all of the     current treatment studies with medicines, including the SSRIs, have excluded patients with     social phobia who have other co-occurring conditions. In fact, 80% of individuals suffering     with primary social phobia have at least one other anxiety. This study will evaluate the     safety and efficacy of sertraline in the treatment of generalized social phobia with     co-occurring anxiety and mood disorders.   "
178801|NCT00182546|"     The main objective of the trial is to determine whether D-dimer testing combined with     assessment of Pre-Test-Probability (using a standardized clinical model) can be used to     markedly simplify the diagnostic process for PE.      It may be safe to omit additional diagnostic testing in selected patients with suspected     pulmonary embolism who have a negative D-dimer test   "
178802|NCT00182559|"     The aim of the study is to determine if the conversion from the immunosuppressive agent     cyclosporine to tacrolimus contributes to an improvement of the cardiovascular risk factors,     better kidney function and immune system.   "
178803|NCT00182572|"     The purpose of this study is to evaluate ways to optimize outcomes from combined     behavioral-pharmacological treatment for opioid-dependent youth.   "
178804|NCT00182585|"     In this study, the investigators are developing and evaluating an interactive,     computer-assisted HIV, STD and disease prevention program for young substance abusers that     incorporates effective components of both prevention science and educational technologies.   "
178805|NCT00182598|"     The purpose of this clinical trial is to examine the efficacy and cost-effectiveness of an     interactive, computer-based psychoeducational system when used by opioid-dependent patients     in office-based buprenorphine treatment.   "
178806|NCT00182611|"     RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.     Giving chemotherapy before surgery may shrink the tumor so that it can be removed. It is not     yet known whether giving S-1 together with cisplatin before surgery is more effective than     surgery followed by S-1 in treating stomach cancer.      PURPOSE: This randomized phase III trial is studying how well giving S-1 together with     cisplatin before surgery works compared to surgery followed by S-1 in treating patients with     stage III stomach cancer.   "
178807|NCT00182624|"     This study will determine whether scanning the prostate using special magnetic resonance     imaging (MRI) techniques can detect prostate cancers with greater accuracy than other     methods. MRI uses a strong magnet and radio waves to produce images of body tissues. Unlike     many cancers, prostate cancer is difficult to see on most imaging studies like x-rays,     computed tomography (CT) scans, and conventional MRI scans. This study will use a magnet     twice as strong as the magnets commonly used in MRI tests.      Patients 18 years of age and older with prostate cancer confirmed by prostate biopsy may be     eligible for this study. Candidates are screened with a medical history, physical     examination, and review of pathology reports.      Participants undergo MRI of the prostate and possibly a biopsy of the prostate gland, as     follows:      Prostate MRI      Before coming to the NIH Clinical Center for the biopsy, patients take a Fleets enema to     empty the rectum of fecal matter. For the MRI, an endorectal coil (a tube containing a     specially designed antenna) is placed in the rectum, which is just behind the prostate. The     coil increases the amount of signal received by the MRI unit. Additional coils may be wrapped     around the pelvis to further improve the quality of the scan. The patient lies on a stretcher     that moves into the scanner. A catheter (plastic tube) is placed in an arm vein for injection     of a contrast agent called gadolinium, which brightens the images. Patients may also be asked     to breathe an oxygen-rich gas through a mask during the scan to test the use of oxygen as a     contrast agent in MRI. Patients may be asked to repeat the MRI to test the reproducibility of     the procedure. The repeat test is optional.      Prostate Biopsy      Depending on the MRI findings, patients may be asked to undergo a prostate biopsy to obtain a     sample of tumor tissue. The tissue is obtained with a needle placed through the rectum.     Medicines may be used to reduce pain during the biopsy and to reduce the chance of infection.   "
178808|NCT00182637|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with     relapsed or refractory cutaneous T-cell lymphoma.   "
178809|NCT00182650|"     RATIONALE: Cellular adoptive immunotherapy uses a person's white blood cells that are treated     in the laboratory to stimulate the immune system in different ways and stop cancer cells from     growing. Rituximab and fludarabine may also prevent the body from making an immune response     against the laboratory-treated white blood cells that are put back into the body.     Interleukin-2 may help the laboratory-treated white blood cells stay in the body longer.     Giving cellular adoptive immunotherapy together with rituximab, fludarabine, and     interleukin-2 may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects of cellular adoptive immunotherapy     in treating patients with relapsed or refractory follicular non-Hodgkin's lymphoma.   "
178810|NCT00182663|"     This phase II trial studies the side effects and how well giving thalidomide, dexamethasone,     and clarithromycin together works in treating patients with multiple myeloma previously     treated with transplant. Biological therapies, such as thalidomide and clarithromycin, may     stimulate the immune system in different ways and stop cancer cells from growing.     Dexamethasone also works in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving thalidomide together with     dexamethasone and clarithromycin after a transplant may be an effective treatment for     multiple myeloma   "
178811|NCT00182689|"     This phase II trial is studying how well sorafenib works in treating patients with extensive     stage small cell lung cancer. Sorafenib may stop the growth of small cell lung cancer by     blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.   "
178812|NCT00182702|"     This phase II trial is studying how well ixabepilone works in treating patients with     metastatic, recurrent, or unresectable kidney cancer. Drugs used in chemotherapy, such as     ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing   "
178813|NCT00182715|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances     to them. It is not yet known whether combination chemotherapy and cetuximab are more     effective than combination chemotherapy alone in treating colorectal cancer.      PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab     to see how well they work compared to combination chemotherapy alone as first-line therapy in     treating patients with metastatic colorectal cancer.   "
178814|NCT00182728|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     during surgery may be an effective treatment for breast cancer.      PURPOSE: This phase II trial is studying how well radiation therapy works in treating older     women who are undergoing surgery for invasive breast cancer.   "
178815|NCT00182741|"     RATIONALE: Calcitriol may cause prostate cancer cells to look more like normal cells, and to     grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing.      PURPOSE: This phase II trial is studying how well giving calcitriol together with     mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.   "
178816|NCT00182754|"     RATIONALE: Octreotide may be an effective treatment for malignant ascites. It is not yet     known whether octreotide is more effective than a placebo in treating malignant ascites.      PURPOSE: This randomized phase III trial is studying octreotide to see how well it works     compared to placebo in treating patients with cancer-related malignant ascites.   "
178817|NCT00182767|"     This trial is studying the side effects and best dose of ixabepilone when given together with     pegylated liposomal doxorubicin hydrochloride and to see how well they work in treating women     with advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or     metastatic breast cancer. Drugs used in chemotherapy, such as ixabepilone and pegylated     liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells.   "
178818|NCT00182780|"     RATIONALE: American ginseng may help relieve cancer-related fatigue.      PURPOSE: This clinical trial is studying how well American ginseng works in treating patients     with cancer-related fatigue.   "
178819|NCT00182793|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as trastuzumab, can block tumor growth in different ways. Some block the ability of     tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. An autologous stem cell transplant may be able to replace     blood-forming cells that were destroyed by chemotherapy. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving combination chemotherapy with or without trastuzumab     followed by an autologous stem cell transplant and radiation therapy may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or     without trastuzumab followed by an autologous stem cell transplant and radiation therapy     works in treating patients with stage III or stage IV breast cancer.   "
178820|NCT00182806|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and gemcitabine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Irinotecan may also increase the effectiveness of gemcitabine. Giving irinotecan     together with gemcitabine may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving irinotecan together with gemcitabine     works in treating patients with recurrent or progressive stage III or stage IV non-small cell     lung cancer.   "
178821|NCT00182819|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. It is not yet known whether     radiation therapy is more effective than temozolomide in treating gliomas.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works compared to temozolomide in treating patients with gliomas.   "
178824|NCT00182858|"     The need to obtain human tissue (blood, urine, saliva, sweat, pleural, pericardia\, ascitic,     synovial, cerebrospinal fluids) for methods development and disease correlation is frequent     in Gerontology Research Center laboratories. This protocol is to create the opportunity to     obtain such tissue samples that have been obtained during the course of usual clinical care     and would be discarded, or alternatively, to obtain such samples during subject and patient     screening for other studies (in this case only blood, urine, saliva, or sweat). Information     derived from such studies is for research purposes only and is not provided to the     patient/subject or their health care provider. When genetic analyses are performed, samples     will have been coded and identifying information linking patient/subject to the sample will     be destroyed. Any genetic information obtained will have no established clinical value and     will not be provided to the subject/patient or their health care provider.      Patients included will be those 18 years or older and who have been identified by the     investigator to have a condition of interest for exploratory studies related to the patient's     illness or other feature that offers the possibility of creating information that leads to     scientifically useful and important studies. Patients will be excluded if obtaining the     sample would be over and above usual clinical care, would result in excessive blood loss, or     the individual is unable to provide informed consent.      The expected outcome is to provide the investigator the opportunity to obtain tissues of     interest for laboratory evaluation with the goal of either better understanding a disease or     to design a scientific study to better understand or treat a disease.   "
178825|NCT00182871|"     The purpose of this study is to assess the effects of testosterone replacement on bone     density, muscle strength, physical performance, quality of life and prostate symptoms in men     selected for low bone mineral density or fracture and some aspect of frailty.   "
178826|NCT00182884|"     The purpose of this study is to explore the efficacy of a perioperative daily dose of     Donepezil (a cholinergic enhancer) in reducing the incidence and severity of delirium.   "
178827|NCT00182897|"     The primary goal of the study is documentation of effectiveness of a home-based intervention     to reduce caregiver burden related to dementia caregiving, improve caregiver health status,     and reduce caregiver and care recipient resource utilization.   "
178828|NCT00182923|"     The purpose of this study is to learn the effect of inherited differences on forearm blood     flow responses to hormones and drugs   "
178829|NCT00182936|"     The purpose of this study is to develop a comprehensive Delirium Abatement Program of care of     delirious patients in the post acute care setting and to evaluate its impact on persistence     and severity of delirium and on functional recovery.   "
178830|NCT00182949|"     Background:      - The island of Sardinia, an Italian region, has a population that is highly interrelated.     Researchers have developed the SardiNIA longitudinal study to examine the possible genetic     factors that predispose individuals to diseases and to various inherited conditions. In the     study, participants will be drawn from four towns in the Ogliastra region (Lanusei, Ilbono,     Elini, and Arzana), and their DNA will be analyzed and compared with a long-term assessment     of various health-related events. The SardiNIA study is designed to improve understanding of     the genetic factors involved in age-associated diseases and disorders, and provide possible     points of intervention that may help prevent diseases.      Objectives:      - To conduct a long-term study of genetics and epidemiology in a small and highly     interrelated population.      Eligibility:      - Individuals at least 18 years of age (at least 14 years of age for Phase 1 of the study)     who live in the province of Ogliastra in eastern Sardinia.      Design:        -  This 10-year study will involve three phases: collecting initial blood samples and          medical history (years 1 to 4), and two sets of follow-up visits to collect additional          data (3 years apart).        -  Participants will provide detailed medical history and information for long-term study,          primarily involving the following aspects:        -  Demographic/family and clinical variables (e.g., medications, fertility,          hospitalizations and surgical procedures, age of relatives who are still alive, age and          cause of death in deceased relatives) (Phase 1)        -  Complete physical examination, including measures of height and weight, blood pressure,          and basic heart function (Phase 1)        -  Blood and urine samples (Phase 1)        -  Heart and lung function tests (Phase 1)        -  Assessment of general personality traits and possible history of depression (Phase 1)        -  Dietary assessment through a food frequency questionnaire (Phase 1)        -  Cognitive tests of attention, memory, and concentration (Phases 1 and 2)        -  Frailty-related tests (e.g., hand grip strength, walking speed, bone strength) (Phases 1          and 2)        -  Eye examination to test for evidence of disease or macular degeneration (Phases 1 and 2)        -  Kidney and thyroid ultrasound (Phases 1, 2, and 3)   "
178831|NCT00182962|"     The purpose of this study is to test the effectiveness of a collaborative model of team care     as compared to usual care in improving functional outcomes among community-dwelling     low-income older adults.   "
178832|NCT00182975|"     The purpose of this study is to determine whether bringing back the DHEA levels of older     persons to the young range produces beneficial effects.   "
178833|NCT00182988|"     The point of this research is to improve the communicative relationship between the caregiver     and care receiver. It is input from the caregiver on these communicative behaviors that will     inform the process of understanding how to reduce the caregiver burden that comes from this     communicative relationship.   "
178834|NCT00183001|"     The purpose of this study is to determine if supplemental vitamin K will reduce age-related     bone loss in elderly men and women above that achieved by supplementation.   "
178835|NCT00183014|"     The purpose of this study is to examine the efficacy of a multifaceted behavioral     intervention aimed at raising walking levels among sedentary older Latinos.   "
178836|NCT00183027|"     The purpose of this study is to develop an effective calorie restricted diet.   "
178837|NCT00183040|"     The purpose of this study is to determine the relationship of deficiencies in testosterone     and growth hormone to loss of muscle mass (sarcopenia) and functional impairment during aging     and whether there is an interaction of these two hormone systems in maintaining normal     skeletal muscle mass and physical function.   "
178838|NCT00183053|"     The purpose of this study is to test an intervention to introduce and implement proximity     alarms on the risk of falls in hospitalized patients.   "
178839|NCT00183066|"     The purpose of this study is to collect bone marrow cells for research purposes.   "
178840|NCT00183079|"     The purpose of this study is to determine whether a brief alcohol intervention reduces     alcohol use and improves depression among depressed patients.   "
178841|NCT00183092|"     The purpose of this clinical trial is to determine the effectiveness of the medication     quinacrine on survival in sporadic Creutzfeldt-Jakob disease (sCJD).   "
178842|NCT00183105|"     The objective of this project was to test whether screening and brief intervention for     unhealthy alcohol use leads to improved alcohol-related outcomes (such as alcohol consumption     and linkage to alcohol assistance) and is cost-effective.   "
178847|NCT00183170|"     The primary goal of the study is to assess the residual effects of heavy drinking on academic     performance. The investigators will also explore whether these effects differ by family     history of alcohol abuse and hangover symptoms, as well as compare males and females with     respect to these effects. The investigators' primary hypothesis is that intoxication (0.10g%     blood alcohol concentration [BAC]) with an alcoholic beverage impairs next-day academic     performance, as measured by scores on quizzes, standardized academic achievement tests, and     standardized neurobehavioral assessments. Their secondary hypothesis is that     family-history-positive individuals will show a greater performance decrement the day after     heavy drinking than family-history-negative individuals.   "
178848|NCT00183183|"     Alcohol abuse is associated with injury, chronic illness, absenteeism from work, and social     costs to families and communities. The goal of this project is to translate motivational     interventions successful in the primary care setting to the Emergency Department (ED)     environment by implementing screening, brief intervention and referral to treatment (SBIRT)     in order to reduce at-risk drinking among ED patients.   "
178849|NCT00183196|"     The purpose of this study is to determine whether, after a period of abstinence, adding 6     weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week     naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence)     treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone     or placebo. All participants will receive alcohol counseling.   "
178850|NCT00183209|"     The purpose of this study is to evaluate the efficacy of a 14-session behavioral intervention     for HIV-infected and uninfected mothers with problem drinking. The intervention targets     alcohol and drug problems, sexual risk behavior, and parenting. We hypothesize that mothers     in the 14-session intervention condition will show improvements in alcohol and drug use,     sexual risk behavior, and parenting in comparison to the control condition, which receives a     one session brief video intervention.   "
178851|NCT00183222|"     The purpose of this study is to determine whether naltrexone (an opiate blocking agent     approved for the treatment of alcohol dependence), ondansetron a serotonin 3 antagonist     medication approved to treat nausea) or their combination are effective in the reduction of     alcohol craving and drinking compared to placebo.   "
178852|NCT00183235|"     The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer)     is effective in reducing of alcohol craving compared to placebo.   "
178853|NCT00183248|"     Alemtuzumab is a man-made antibody used to treat certain blood disorders. This study will     evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system     suppressing medications with or without infusions of bone marrow stem cells from the kidney     donor. The purpose of this study is to find out which strategy is more effective in     preventing organ rejection and maintaining patient health.   "
178854|NCT00183261|"     The purpose of this study is to determine whether the HIV vaccine MRKAd5 HIV-1 gag/pol/nef     followed by treatment interruption can increase immune system function in adults with acute     or recent HIV infection who have started taking anti-HIV drugs.   "
178855|NCT00183274|"     This study will assess the effectiveness of venlafaxine XR, randomized to either venlafaxine     XR or placebo in preventing the relapse of generalized anxiety disorder after 6 months of     treatment versus 12 months of treatment.   "
178856|NCT00183287|"     The purpose of this study is to monitor the progression of HIV infection and HIV-related     disease processes in patients who have previously participated in HIV clinical trials.   "
178857|NCT00183300|"     This study will determine the effectiveness of immediate treatment with prolonged exposure     therapy (PE) versus delaying treatment with PE in altering neuroendocrine-related symptoms of     post-traumatic stress disorder in women.   "
178858|NCT00183313|"     This study will determine the effectiveness of medical case management in improving the     medical care of people with mental disorders or substance abuse problems.   "
178859|NCT00183326|"     This study will determine whether trauma-focused cognitive behavioral therapy (TF-CBT) is     more effective than child-centered therapy (CCT) in reducing post traumatic stress disorder     (PTSD) in children exposed to domestic violence (DV).   "
178860|NCT00170833|"     This study will assess the safety and efficacy of everolimus with basiliximab,     corticosteroids and lower levels versus higher levels of tacrolimus in de novo renal     transplant recipients.   "
178861|NCT00170846|"     The study is designed to evaluate whether the initiation of everolimus together with the     reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in     the maintenance of renal transplant recipients with renal impairment by reducing the     progression of chronic allograft nephropathy. The development of atherosclerosis in the     native arteries of the patients will also be explored.   "
178862|NCT00170859|"     In this study two immunosuppressive regimens (everolimus in combination with cyclosporine     microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose     cyclosporine microemulsion are compared in maintenance heart transplant recipients with     impaired renal function.   "
178863|NCT00170872|"     This study tested the safety, tolerability and efficacy of lumiracoxib - a COX-2 inhibitor-     in patients with primary knee osteoarthritis or rheumatoid arthritis.   "
178864|NCT00170885|"     The purpose of the study in de novo renal transplant patients is to evaluate the effect on     renal function of an optimized new regimen in comparison with the standard everolimus     exposure plus a low-dose cyclosporine microemulsion regimen.   "
178865|NCT00170898|"     This study is designed to develop our understanding of the risk-benefit of using lumiracoxib     in patients with acute musculoskeletal pain due to uncomplicated soft tissue injury.   "
178866|NCT00170911|"     AAE581 is a specific inhibitor of the cysteine protease cathepsin K. This trial is designed     to provide detailed information about the effects( efficacy and safety) of AAE581 on Bone     Mineral Density.   "
178867|NCT00170924|"     Patients who have had high blood pressure for a long time may have diastolic dysfunction.     Diastolic Dysfunction is when your heart has difficulty filling and emptying, and relaxing     adequately.      This study is to find out if Valsartan) will improve the ability of the heart to fill, empty,     and relax appropriately when given alone or with other medicines to treat high blood     pressure.   "
178868|NCT00170937|"     The metabolic syndrome is a classification for patients with a constellation of risk factors     which may include abdominal obesity, hypertension, elevated blood lipids and sugar. Three or     more of these factors together constitute the metabolic syndrome and place these patients at     a greater risk for the development of diabetes and cardiovascular diseases. The purpose of     this study is to determine whether two common drugs to lower blood pressure, whether used     separately or in combination, have different effects on blood sugar levels in patients     diagnosed with the metabolic syndrome.   "
178869|NCT00170950|"     A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to     evaluate the effectiveness of the combination on reducing heart disease and death in a high     risk hypertensive population.   "
178870|NCT00170963|"     This study will test the effectiveness and safety of a combination treatment in patients     whose blood pressure is not controlled with a single medication   "
178871|NCT00170976|"     A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.   "
178872|NCT00170989|"     This study will test the effectiveness and safety of a combination treatment in patients     whose blood pressure is not controlled with a single medication.   "
178873|NCT00171002|"     This study will test the effectiveness and safety of a combination treatment in patients     whose blood pressure is not controlled with a single medication   "
178874|NCT00171015|"     To evaluate the efficacy of valsartan 160 mg/HCTZ 25 mg in patients not adequately responding     to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan     medoxomil 20 mg plus HCTZ 12.5 mg by testing the hypothesis that valsartan 160 mg/HCTZ 25 mg     significantly reduces the trough mean sitting diastolic blood pressure (MSDBP) after a 4-week     treatment in the nonresponder population.   "
178875|NCT00171028|"     Drugs used to treat hypertension in adults should also be effective in treating high blood     pressure in infants and children. This study will test the safety and efficacy of valsartan     in lowering blood pressure in children 1 - 5 years old whose parents grant permission to     participate.   "
178876|NCT00171041|"     Drugs used to treat high blood pressure in adults should also be effective in treating high     blood pressure in children and adolescents. This study will test the safety and efficacy of     valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose     parent(s)/guardian(s) grant permission to participate.   "
178877|NCT00171054|"     The purpose of this study is compare treatment with valsartan with the possible addition of a     diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the     possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment     on the stiffness of the blood vessels will be studied.   "
178878|NCT00171067|"     The purpose of this study is to compare if the combination of valsartan 320 mg/lisinopril 20     mg versus the monotherapies of lisinopril 40 mg or valsartan 320 mg will result in a greater     decrease of urinary albumin excretion measured as urinary albumin/creatinine ratio (UACR) in     the first morning urine of hypertensive subjects with previously diagnosed microalbuminuria     (MAU).   "
178879|NCT00171080|"     The purpose of the study is to compare the efficacy, safety and tolerability of valsartan 80     mg (with a starting dose of 40 mg) to irbesartan 150 mg (with a starting dose of 75 mg) in     patients on long-term haemodialysis with mild to moderate increased mean supine systolic     blood pressure (MSSBP).   "
178880|NCT00171093|"     This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and     80 mg simvastatin together compared to using either one alone in lowering blood pressure and     LDL cholesterol. After discontinuing current drug therapies for hypertension and     hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg     valsartan+placebo, or 80mg simvastatin+placebo..   "
178881|NCT00171106|"     This study will test the effects of valsartan versus placebo on exercise tolerance in     patients with symptoms of heart failure   "
178882|NCT00171119|"     The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the     combination of both in reduction of microalbuminuria in Type 2 diabetic patients.   "
178883|NCT00171132|"     The purpose of the study is to show that valsartan compared to atenolol has favorable effects     on exercise capacity, quality of life, diastolic function and elevated blood pressure in     hypertensive postmenopausal overweight women with impaired exercise tolerance despite normal     left ventricular ejection fraction (LVEF).   "
178884|NCT00171145|"     This study will assess the efficacy of a 12-week treatment with darifenacin in increasing     warning time, the time from first sensation of urgency to voiding, in patients with OAB.   "
178885|NCT00171158|"     This extension II study will allow for further follow-up of the disease under treatment with     imatinib mesylate and allow the patients to continue to receive imatinib mesylate.   "
178886|NCT00171171|"     Because patients with beta-thalassemia are unable to actively eliminate iron from the body,     toxic and eventually lethal levels of iron can accumulate as a result of repeated blood     transfusions. This study will evaluate the efficacy, safety and tolerability of deferasirox.   "
178887|NCT00171184|"     The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks     treatment with darifenacin in patients aged >Ý 65 years with OAB.   "
178888|NCT00171210|"     A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator     was conducted to investigate the efficacy of deferasirox in regularly transfused patients     with β-thalassemia 2 years of age and older. Patients who successfully completed this main     trial may continue in this extension trial to receive chelation therapy with deferasirox for     an additional 4 years.      The objective of this study is to assess the efficacy and long-term safety of deferasirox in     regularly transfused patients with β-thalassemia 2 years of age and older.   "
178889|NCT00171223|"     This extension study will allow for further follow-up of the disease under treatment with     imatinib mesylate and allow patients to continue to receive imatinib mesylate.   "
178890|NCT00171236|"     The purpose of the study is to assess the safety and efficacy of fluvastatin in children     diagnosed with heterozygous familial hypercholesterolemia   "
178891|NCT00171249|"     This extension II study will allow for further follow-up of the disease under treatment with     imatinib mesylate and allow the patients to continue to receive imatinib mesylate.   "
178896|NCT00171314|"     Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment     of breast cancer and will be randomized to a treatment group to receive either upfront     zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4     mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when     either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar     spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture     discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.   "
178897|NCT00171327|"     Patients with mild to moderate hypertension, dyslipidemia (imbalanced blood lipids) and     decreased vascular dilatation, receiving a cholesterol lowering diet were given either     valsartan or fluvastatin for 8 weeks. At week 8 all patients were administered a combination     treatment with valsartan 160 mg and fluvastatin 80 mg.   "
178898|NCT00171340|"     Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment     of breast cancer and will be randomized to a treatment group to receive either upfront     zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4     mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when     either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar     spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture     discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.   "
178899|NCT00171353|"     One hundred twenty patients with arterial hypertension and albuminuria (some amount of     albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure.     Hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.   "
178900|NCT00176657|"     The avoidance of blood transfusions benefits the patient. Cardiopulmonary bypass (CPB) is     routinely used in complex cardiac surgeries. This device requires circulating blood through     an oxygenator and pump while the heart is stopped. Upon discontinuation of CPB, the volume of     blood in the CPB circuit, approximately 1 to 1.5 liters, is currently processed for the red     cell components of the blood. Yet, all the other blood components are available in this     volume of blood, but are discarded. The Hemobag filters allow for whole blood reinfusion     rather than just red cell reinfusion. Thus, the patient’s own platelets, for example, are     returned to the patient. The product is just being used clinically and we, the investigators     at University of Medicine and Dentistry, New Jersey, have been asked to perform a study on     our normal practice (red blood cell return as described above) compared to the whole blood     return available with the Hemobag™.   "
178901|NCT00176670|"     Preoperative anxiety is characterized by subjective feelings of tension, apprehension,     nervousness and worry. In children, preoperative anxiety is reported to result in     postoperative negative psychological effects, including nightmares, separation anxiety,     eating problems and increased fear of doctors. Anxiety in children can be expressed in many     forms. Many children look scared, become agitated, breathe deeply, tremble, and stop talking     or playing and start to cry. They may unexpectedly urinate or may actively attempt to escape     from the medical personnel. These reactions reflect the child's fear of separation from the     parents, as well as loss of control, unfamiliar routines, instruments and hospital procedures     [1].      Previous studies have assessed anxiety in children during the preoperative period and the     effects of premedication and parental presence during induction of anesthesia (PPIA) [2].     Midazolam has been proven to reduce preoperative anxiety in children [3]. Side effects     related to oral midazolam administered to healthy children are minimal and the drug can be     reversed with flumazenil but post operative recovery may be delayed in those children     undergoing a short surgical procedure. It is the experience of the investigator that there     are some children who have such low levels of anxiety they do not require any intervention      Distraction may be particularly helpful in children ages 6-12 as these children may not     receive preoperative medication due to their curiosity about the environment. Previous     studies regarding distraction therapy have focused on the parent either blowing bubbles or     reading to a child [4]. Studies where the child is actively engaged in a distraction activity     have not been documented.      The purpose of this investigation is to determine whether in the presence of a parent an     interactive distraction intervention, i.e. Game Boy which is a hand held video game, is as     effective as preoperative Midazolam in reducing preoperative anxiety. This study may help in     the search for a low cost and easy to implement method of reducing anxiety for children     undergoing surgery.   "
178902|NCT00176683|"     The purpose of this study is to assess if capnography can be utilized to assist in the     process of endotracheal intubation; specifically, in locating the glottic opening. Ultimately     this would result in a new use of capnography to aid in securing normal and difficult     airways. Currently capnography is only utilized for the confirmation of endotracheal tube     placement.      If successful, this study will provide information, and allow for the development of     instrumentation that will assist in difficult airway management; specifically, in locating     the glottic opening when visualization may be impaired. Ultimately, this technique will be     useful for routine and emergency airway management.   "
178903|NCT00176696|"     Reducing postoperative pain leads to increased patient comfort and facilitates speedy     recovery and discharge from the hospital following surgery. The focus of controlling     postoperative pain has gradually shifted from postoperative management to intraoperative     management. The investigators believe that this study is a unique opportunity to assess the     adequacy of intraoperative analgesia, allowing for immediate administration of the     appropriate opioid analgesics. The purpose of this research is to bring to light the     applicability of facial electromyography as an intraoperative solution to postoperative pain     management.   "
178911|NCT00176813|"     This study will examine an investigational (experimental) treatment using gemcitabine,     cisplatin, and celecoxib. Preliminary studies have shown that this experimental treatment may     be effective in reducing the size of cancerous tumors and/or preventing further tumor growth.      This is a phase II clinical trial studying the reactions of the patient's body and their     tumor to the combination of gemcitabine, cisplatin, and celecoxib. The purpose of this study     is to see if the tumor responds to this treatment and to determine how long the response     lasts. This study will also look at what kind of side effects this experimental treatment     causes and see how often these side effects occur. Blood levels of celecoxib will be measured     to find out how this treatment affects factors (proteins) involved in new blood vessel     formation and tumor growth (angiogenesis).   "
179180|NCT00180401|"     The purpose of this study is to compare the benefit of cardiac resynchronization therapy     (CRT)-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of     > 150 ms.   "
178913|NCT00176839|"     This protocol using busulfan, cyclophosphamide and melphalan has been designed as     conditioning therapy for patients receiving stem cell transplantation for acute leukemia or     myelodysplastic syndrome (MDS). The hypothesis is that this new regimen will be well     tolerated and will cure the patient.   "
178904|NCT00176722|"     Postoperative visual loss resulting from surgical procedures not performed on the eye is a     devastating outcome for the patient and poorly understood by the medical community. It is     potentially a preventable complication. Diminished blood supply to the optic nerve, affecting     both the anterior or posterior portions of the optic nerve, is the most common cause of     postoperative visual loss. Other, less common causes include occlusion of the retinal artery     and vein, a retinal embolism and cortical blindness. The incidence of postoperative visual     loss increases in patients undergoing cardiopulmonary bypass and prone spinal surgery.     Although the etiology of postoperative visual loss is unknown, it is thought to be     multifactorial, and several potential risk factors have been identified, including degree of     low blood pressure, preoperative hematocrit, external compression of the eye, amount of blood     loss, prolonged duration of surgical time and lying in the face down position. The     investigators believe this study is a unique opportunity to examine the mechanisms     responsible for the antecedents to postoperative visual loss (POVL) and ischemic optic     neuropathy (ION), a devastating complication of (usually) an elective surgical procedure. The     purpose of this research is to try and determine the potential variables responsible for     postoperative visual loss which will assist the medical community in devising methods for its     prevention.   "
178905|NCT00176735|"     Pancreatic cancer has traditionally been treated with chemotherapy and radiation therapy with     limited results. Preliminary studies of parts of this program in patients with advanced     pancreatic cancer have produced favorable results with acceptable side effects. We feel that     this treatment sequence may help to slow and/or control the growth of pancreatic cancer.      This study will help doctors learn whether pancreatic cancer will respond to this treatment.     This study will use the combination of two chemotherapy drugs, gemcitabine and cisplatin,     before and after treatment with radiation therapy and an oral chemotherapy drug called     capecitabine. This sequence of combination chemotherapy before and after radiation therapy,     and radiation therapy with the drug capecitabine is what is under study. Parts of this     sequence, for example, the combination of gemcitabine and cisplatin, have shown promising     results in the treatment of pancreatic cancer. This research study is an attempt to combine     these various parts.   "
178906|NCT00176748|"     This study is being done to find out the good and bad effects of an investigational drug that     is not approved for sale, called AG-013736. Tumors need blood vessels in order to continue to     grow, and AG-013736 is thought to work by playing a role in preventing new blood vessels from     growing. We want to see if AG-013736 has any effect on your disease by making your tumor     smaller and if so, for how long. We also want to test the safety [the effect on your body] of     AG-013736 and to measure the amount of AG-013736 that gets into your blood. AG-013736 has     been given to over 140 patients with cancer on other studies.   "
178907|NCT00176761|"     This study is being conducted to determine the efficacy, side effects, and toxicity of an     investigational vaccine that consists of tumor-pulsed dendritic cells administered with an     immune stimulating drug called interleukin-2 (IL-2). Dendritic cells are immune cells that     are obtained from a subject's blood and are important in the body’s immune response to     foreign substances. This study will examine the response of a subject's immune system after     receiving several vaccinations containing their own dendritic cells which have been exposed     to dead fragments of their cancer cells in the laboratory. This may result in sensitizing a     subject's dendritic cells to their cancer cells so that their dendritic cells will react with     other cells of the immune system and attack the cancer. It has been shown in the laboratory     that dendritic cells exposed to cancer cell fragments can provide lymphocytes (a type of     white blood cell) with signals they require in order to become fully activated and acquire     the ability to kill cancer cells.   "
178908|NCT00176774|"     This study will examine an investigational (experimental) agent Tetrathiomolybdate (TM)     combined with the chemotherapy drugs Irinotecan, 5-Fluorouracil (5-FU) and Leucovorin (LV).     This study will evaluate the safety and tolerability of the combination of these drugs when     they are used in the treatment of metastatic colorectal cancer.      This is a pilot clinical trial which will be studying the reactions of the patient's body and     tumor to the experimental treatment described above. The purpose of this study is to find out     what kind of side effects this experimental treatment causes and see how often these side     effects occur.   "
178909|NCT00176787|"     This study will use an experimental combination of treatment with the drug Capecitabine and     radiation therapy prior to an operation for removal of the patient's tumor. The drug     Capecitabine is an oral form of a drug called 5-FU which has been widely used to treat rectal     cancer.      This is a phase II clinical trial, which means that the physician will be studying the     reactions of the patient's body and tumor to treatment with Capecitabine and radiation     therapy. The purpose of this study is to see if the tumor responds to this treatment and to     determine how long the response lasts. The study also will see what kind of side effects this     experimental treatment causes and see how often these side effects occur.      Preliminary human studies using Capecitabine and radiation therapy have produced encouraging     results with acceptable side effects.   "
178910|NCT00176800|"     Surgery has been the standard of care for esophageal cancer for many years, with limited     success. At present, several studies are underway nationwide which utilize chemotherapy     combined with radiation therapy prior to the usual surgical regimen. Although this treatment     offers some possibility for improvement of patients with esophageal cancer, there remains a     significant need for development of new drugs that can substantially impact survival      Investigators at the University of Michigan have been evaluating inhibitors of tumor blood     vessel growth (angiogenesis). Specifically, they are evaluating the role of copper in     angiogenesis. Copper has been shown to be both a requirement and a potent stimulus for     angiogenesis.      Previous studies have shown Tetrathiomolybdate (TM) to rapidly lower copper levels in the     blood. The physicians at the University of Michigan are studying whether the addition of TM     to the chemoradiation and surgery may increase survival for patients with esophageal cancer.   "
178912|NCT00176826|"     The hypothesis is to determine if a preparative regimen of busulfan, cyclophosphamide, and     antithymocyte globulin (ATG) plus allogeneic stem cell transplantation will be effective in     the treatment of immune deficiencies and histiocytic disorders.   "
178939|NCT00183599|"     This study will compare four different combinations and durations of motivational enhancement     therapy, cognitive behavioral therapy, and brief advice treatments for gambling versus a     non-intervention condition to determine which is most effective in reducing problem gambling.   "
178914|NCT00176852|"     This study tests the clinical outcomes of one of two preparative regimens (determined by     available donor source) in patients with non-malignant hemoglobinopathies. The researchers     hypothesize that these regimens will have a positive effect on post transplant engraftment     and the incidence of graft-versus-host-disease.      Regimen A2 has replaced Regimen A in this study. Two patients were treated on Regimen A but     did not have evidence of initial engraftment thus triggering the stopping rule for that arm     of this study.   "
178915|NCT00176865|"     This study tests the clinical outcomes of a preparative regimen of fludarabine (FLU),     anti-thymocyte globulin (ATG)/or Campath, and melphalan; followed by hematopoietic stem cell     transplant, and a post transplant regimen of Cyclosporin A (CsA) in patients with immunologic     or histiocytic disorders. The researchers hypothesize that this regimen will have a positive     effect on post transplant engraftment and the incidence of graft-versus-host-disease (GVHD).      Patients will be randomized biologically into one of 3 arms based upon donor availability:     (a) human leukocyte antigen (HLA) genotypic matched sibling donor, (b) HLA phenotypic matched     unrelated peripheral blood stem cell (PBSC) donor, (c) two HLA 0-2 antigen mismatched     unrelated cord blood donors (double cord).   "
178916|NCT00176878|"     The researchers hypothesize that it will be possible to perform unrelated bone marrow or cord     blood transplants in a safer manner by using less intensive therapy yet still achieve an     acceptable level of donor cell engraftment for non-malignant congenital bone marrow failure     disorders.   "
178917|NCT00176891|"     The investigators hypothesize that weekly infusions of Laronidase ERT for 10-12 weeks prior     to transplant and 8 weeks following transplant will result in a reduction of     glycosaminoglycans (GAG) burden that is associated with decreased complications following     transplant.   "
178918|NCT00176904|"     The purpose of this study is to determine the safety and engraftment of donor hematopoietic     cells using this conditioning regimen in patients undergoing a hematopoietic (blood forming)     cell transplant for an inherited metabolic storage disease.   "
178919|NCT00176917|"     The purpose of this study is to determine the safety and engraftment of donor hematopoietic     cells using this conditioning regimen in patients undergoing a hematopoietic (blood forming)     cell transplant for Hurler syndrome, Maroteaux Lamy syndrome, Mannosidosis, or I-cell     disease.   "
178920|NCT00183339|"     This study is a pilot study to evaluate the feasibility and safety of conducting a year long,     double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance     developmental processes in core areas impacted by autism.   "
178921|NCT00183352|"     This study will determine the effect of medication for bipolar disorder on the reproductive     function and whether mood changes occur during the menstrual cycle in women with bipolar     disorder.   "
178922|NCT00183365|"     This study will test the Protecting Families Program, a 10-week prevention program for     depressed parents and their pre-teenage children, by comparing the effectiveness of the     program versus parent training alone.   "
178923|NCT00183378|"     This study will compare four different behavioral treatment programs to determine which is     most effective in reducing night-time disturbances in individuals with Alzheimer's disease     (AD).   "
178924|NCT00183391|"     This study will determine the effectiveness of stimulant and nonstimulant medication in     treating the symptoms of attention deficit hyperactivity disorder (ADHD) in children and     adolescents.   "
178925|NCT00183404|"     This study will determine the short- and long-term safety and effectiveness of the drug     olanzapine (Zyprexa®) for reducing symptoms of autism in children.   "
178926|NCT00183417|"     This study will compare the effectiveness of two programs designed to prevent depression in     adolescents.   "
178927|NCT00183430|"     This study will evaluate the effectiveness of prazosin in treating post-traumatic stress     disorder caused by noncombat trauma in individuals taking selective serotonin reuptake     inhibitors.   "
178928|NCT00183443|"     This study will determine the effectiveness of three different drug therapies in treating the     symptoms of mania.   "
178929|NCT00183456|"     This study will determine the effectiveness of a peer outreach intervention in preventing HIV     infection in adults at high risk for contracting HIV and other sexually transmitted diseases     (STDs).   "
178930|NCT00183469|"     This study will compare two different antidepressant treatment regimens to determine which is     more effective in reducing symptoms of bipolar depression.   "
178931|NCT00183482|"     This study will determine the effectiveness of cognitive behavioral therapy (CBT) versus     educational treatment in preventing depression in the children of parents with a history of     depression.   "
178932|NCT00183495|"     This study will examine how various factors, such as psychiatric symptoms, gender, social     support, substance use, and attitudes toward medication, affect treatment adherence in     individuals with bipolar disorder.   "
178933|NCT00183508|"     This study will develop a treatment for firefighters experiencing symptoms of acute stress     disorder (ASD). Effective treatments may reduce immediate symptoms and prevent the     development of more chronic conditions, such as post-traumatic stress disorder (PTSD).   "
178934|NCT00183521|"     This study will compare two different breathing regulation techniques to determine which is     more effective in reducing the rate of panic attacks in people with panic disorder.   "
178935|NCT00183547|"     This study will determine the effectiveness of the Living in Harmony depression prevention     program in preventing depressive symptoms among pregnant American Indian adolescents during     pregnancy and after giving birth.   "
178936|NCT00183560|"     This study will determine the effectiveness of mindfulness-based cognitive therapy (MBCT) in     preventing depression relapse.   "
178937|NCT00183573|"     This study will determine the effectiveness of a two-step HIV prevention program in reducing     risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs).   "
178938|NCT00183586|"     This study will compare specific family therapy, standard family systems therapy, and     standard individual psychotherapy to determine which is most effective in treating adolescent     anorexia nervosa.   "
178941|NCT00183625|"     This study will compare employment support with behavioral skills training to employment     support alone in schizophrenia patients taking either risperidone or olanzapine to determine     which is more effective in helping the patients maintain a job.   "
178943|NCT00183651|"     This study is a component analysis of dialectical behavior therapy (DBT) to determine the     importance of DBT skills training and DBT individual therapy in treating suicidal women with     borderline personality disorder.   "
178944|NCT00183677|"     This study will evaluate changes in brain energy metabolism due to treatment with     escitalopram in people with major depressive disorder.   "
178945|NCT00183690|"     This study will compare the effectiveness of prolonged exposure therapy versus active     psychotherapy in treating post-traumatic stress disorder (PTSD) in adolescents.   "
178946|NCT00188812|"     one year extension study following a previous double-blind study to evaluate safety of the     drug   "
178947|NCT00188825|"     The study will evaluate the efficacy and safety of basiliximab Vs placebo as induction     therapy combined with standard triple immunosuppression therapy, in the prevention of acute     rejection episodes and prevention of Bronchiolitis Obliterans Syndrome.   "
178948|NCT00188838|"     To examine the impact of cognitive-behavioural therapy on both the episodic and functional     outcome of bipolar disorder, in combination with pharmacotherapy.      Primary Hypothesis is twofold:        1. Cognitive Behavioural Therapy will reduce the total symptom burden, as measured both by          percentage of time spent ill (both syndromic and subsyndromal) and number of episodes,          as compared to psychoeducation        2. Cognitive behavioural therapy will reduce social and occupational disability to a          greater extent than psychoeducation.   "
178949|NCT00188851|"     The purpose of this study is to assess the virologic impact of switching     treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with     or without a 12 week STI prior to the switch.      Hypothesis: A STI prior to starting a salvage regimen will result in an improved virologic     response.   "
178950|NCT00188864|"     Brain metastases occur when cancer cells from the initial tumour site (for example, lung or     breast) spread to the brain. This develops in approximately 10% - 30% of adults with cancer.     They can produce different complaints related to their effect on brain functioning, decrease     in a person's ability to carry on with their usual activities, a reduction in the quality of     life and shortened life expectancy.      The standard treatment particularly for people with more than one brain metastasis consists     of palliative radiation therapy to the brain and steroids. Steroids (such as Decadron or     Dexamethasone) are medication used to reduce swelling around the tumour, and thus symptoms     improve. Steroids could be very helpful but have a number of potential side effects,     particularly if used for longer periods of time. There is no standard dose of Decadron used     in treating brain metastases patients. The most commonly dose used is 4 mg four times/day.      This study will assess if lower doses of Decadron - 8 mg every morning for symptomatic     patients and 4 mg every morning for asymptomatic patients - are effective in maintaining     symptom control in patients with brain metastases, without neurological deterioration that     necessitates the patient to go back or to a higher dose at any time. This information will     help also in understanding how to decrease the side effects associated with higher doses of     steroids in people with your condition.   "
178951|NCT00188877|"     Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in     the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of     these normal tissues. Standard radiation treatment techniques using three or four radiation     beams cannot avoid delivering some dose of radiation to these normal tissues that do not need     to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of     computer-controlled radiation beams aimed at your cancer to try to lower the amount of     radiation that normal tissues receive, while still delivering the desired amount of radiation     to your cancer and to areas that your doctor thinks may have cancer cells.      The doctors at Princess Margaret Hospital are conducting this study in order to test whether     the use of IMRT techniques can improve the chance of controlling your cancer in the head and     neck region.   "
178952|NCT00188890|"     Occupational exposure to asbestos is known increase the risk of developing cancer of the     lungs (bronchogenic carcinoma) or of the pleura (mesothelioma). Symptoms are subtle and     non-specific, diagnosis is often late and the prognosis consequently is dismal. Currently     there is no accepted non-invasive tool for the early diagnosis of mesothelioma or lung cancer     in asbestos-exposed subjects. In the last decade, low-dose computed tomography (LDCT) has     been successfully developed and validated for the early diagnosis of lung cancer in high-risk     smokers. Malignant mesothelioma might, in an early stage, resemble a benign pleural plaque,     which is a common finding after asbestos exposure. We target to develop low-dose CT as a tool     to serially image the pleural plaques, quantify their individual and overall volume, compute     the growth rate with time, and, as such, identify the presence of mesothelioma early, before     symptoms occur.   "
178953|NCT00188903|"     Left ventricular (LV) diastolic dysfunction is a common manifestation of heart disease that     is responsible for significant morbidity and mortality.It is present when the ventricular     filling is impaired as a result of delayed relaxation or decreased compliance. During     Coronary artery bypass grafting (CABG) surgery, LV diastolic dysfunction is a frequent     occurrence. Failure of the left ventricle to dilate normally causes an increase in LV filling     pressure. Atrial fibrillation (AF) is a common complication after cardiac surgery affecting     20-30% of patients undergoing coronary revascularization procedures. AF is associated with     significant morbidity and mortality and has been identified as a causative factor of     increased length of both hospital and intensive care unit (ICU) stay after CABG surgery,     resulting in increased resource utilization and medical care costs.The primary aim of this     study is to determine if patients with preoperative diastolic dysfunction are exposed to     higher risk of AF after coronary revascularization surgery.   "
178954|NCT00188916|"     This is a clinical trial comparing surgical conditions during one-lung ventilation with three     different bronchial blockers or with double-lumen endobronchial tubes.   "
187718|NCT00304863|"     The purpose of this study is to determine whether dietary supplementation with Lactobacillus     GG will reduce the rate of failure or relapse following treatment of CDAD with metronidazole.   "
178967|NCT00189085|"     In the present study the investigators are researching the effects of the cholesterol     absorption inhibitor ezetimibe on postprandial lipemia and postprandial endothelial function     in patients with the metabolic syndrome. The lipid-lowering effect of high-dose statin     monotherapy on fasting lipids is equal to the combination therapy of low-dose statin and     ezetimibe.   "
178955|NCT00188929|"     In this study the treatment process will be closely monitored using a novel imaging     technology, a PET/CT scanner. PET stands for Positron Emission Tomography and in this case it     will be combined with a conventional x-ray Computerized Tomography (CT) scan. This is not a     study of any particular form of treatment. The treatment you receive will be the most     appropriate standard treatment whether you are in the study or not.      The goal of radiation therapy is to deliver a given amount of radiation dose to the area     where there is a lymphoma tumour. We are doing this study to see which part of the tumour     reacts to the radiation treatment, and which part does not react, by monitoring the progress     of your treatment with a combined PET/CT scan. In particular, changes of the size and shape     of the tumour that occur during the treatment can be detected and will be visible on the     images. These images will be thoroughly analysed. The ability of the PET/CT scanner to detect     these changes during a course of radiation treatment will be the subject of this study. We     will also be able to see if this information will eventually relate to or predict whether     lymphoma tumours will be completely eradicated by the treatment.   "
178956|NCT00188942|"     This study employs functional magnetic resonance imaging to compare brain activation patterns     during a depressive episode in patients diagnosed with bipolar disorder, major depressive     disorder, and a group of healthy control subjects. Depressed patients will be treated with a     combination of fluoxetine and olanzapine and undergo MRI scans before, during, and after     pharmacotherapy.   "
178957|NCT00188955|"     The purpose of this study is to determine whether treatment with sirolimus, in combination     with low-dose tacrolimus and prednisone, is effective for the treatment of chronic allograft     nephropathy (progressive scarring) in children who have previously received a kidney     transplant. This treatment is compared to the standard therapy which uses low-dose     tacrolimus, mycophenolate mofetil and prednisons.      This study is a pilot study that will determine whether treatment with sirolimus reduces or     improves the rate of scarring seen on kidney biopsy of the transplanted kidney over time,     compared to children who continue to be treated with mycophenolate mofetil.   "
178958|NCT00188968|"     Very premature infants uniformly do not have mature functioning lungs to breathe well nor     mature regulation mechanisms to breathe regularly. Assistance with a mechanical respirator is     common. However, prolonged use of a respirator can itself cause long-term complications.     Furthermore, commonly used drugs to improve the regularity of breathing may have long-term     consequence only recently recognized. This study will compare two different types of     assistance using a nasally applied breathing assist device. The aim is to see which type of     assistance is best at avoiding the need for both prolonged respirator use and drugs to     regulate breathing.   "
178959|NCT00188981|"     The Dutch Prediction of Psychosis Study (DUPS) is a prospective study of predictors of the     transition to psychosis in help-seeking adolescents at high risk for developing a first     psychotic episode. The aim of the project is supplemented by a systematic account of the     pathways to care, the disabilities and needs and the therapeutic interventions that are     currently used in this population.      Multi-level assessment includes behavioral and cognitive variables as well as structural     brain imaging and neurophysiological data. Subjects will be followed up at regular intervals     during (at least) two years to monitor the development of their (psychotic) symptoms. This     will allow us to analyze the predictive validity of the variables.   "
178960|NCT00188994|"     The purpose of this investigation is to develop a means to improve the recovery of cardiac     metabolism and ventricular function following coronary artery bypass surgery (CABG) in     patients with poor preoperative ventricular function (e.g. ejection fraction <40%).   "
178961|NCT00189007|"     A former study (submitted) in 32 severely asphyxiated infants participating in a randomized     double blind study, in which early postnatal allopurinol or a placebo (within 4 hours after     birth) was administered to reduce free radical formation and consequently     reperfusion/reoxygenation injury to the newborn brain, showed an unaltered high mortality and     no clinically relevant improvement in morbidity in infants treated with allopurinol. It was     hypothesized that postnatal allopurinol treatment started too late to reduce     reperfusion-induced free radical surge and that initiating allopurinol treatment of the fetus     with (imminent) hypoxia already via the mother during labor will be more effective to reduce     free radical-induced post-asphyxial brain damage.   "
178962|NCT00189020|"     Two( 2) or three (3) instead of four vaccinations before the age of 6 months with     pneumococcal conjugate vaccine are presumed to protect children against invasive pneumococcal     disease like meningitis, at least on the short term till 18-24 months of age. The current     hypothesis in this study is 2 or 3 vaccinations will protect against IPD but will not alter     pneumococcal nasopharyngeal carriage in infants, and consequently not change pneumococcal     transmission and induce no herd-immunity. Furthermore, antibody development and memory may     benefit from carriage of vaccine type S. pneumoniae   "
178963|NCT00189033|"     The purpose of this study is to assess the role of dietary fibre in Irritable Bowel Syndrome     (IBS) treatment, in particular the role of increasing the content of soluble or insoluble     fibres in the daily diet. The primary objective is to compare soluble (psyllium) and     insoluble (bran) to placebo, administered over 12 weeks in patients with ‘probable’ or     ‘definite’ Irritable Bowel Syndrome. The primary efficacy parameter is the responder rate     based on weekly assessment of adequate relief of IBS symptoms. Secondary efficacy parameters     include changes in IBS related symptoms (abdominal pain, bowel habits) and quality of life.   "
178964|NCT00189046|"     It has been suggested that cognitive functioning is impaired in chronic pain patients. Since     most of these pain patients engage in daily activities including driving, it was hypothezised     that they may have an increased risk of becoming involved in traffic accidents.   "
178965|NCT00189059|"     The acute and subchronic effects of amitriptyline were compared to placebo in a double-blind     crossover randomized study on driving ability and driving-related skills in chronic     neuropathic pain patients.It was hypothesized that nocturnally administered 25 mg     amitriptyline might affect driving performance negatively after acute, but not after     subchronic treatment.   "
178966|NCT00189072|"     The aim of this study was to explore the effects of pain on the one hand and the effects of     treatment of pain with gabapentin (900, 1200, 1800 or 2400 mg) on the other hand on actual     driving performance and several laboratory tests in patients with neuropathic pain. It was     hypothesized that gabapentin might influence performance after acute but not after subchronic     administration.   "
178968|NCT00189098|"     Chronic suppurative otitis media is one of the most common chronic infections in children     worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries, it is     treated primarily with antibiotics; in other countries such as the Netherlands a surgical     approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes     or a tympanomastoidectomy is preferred. There is however, no agreement on the management of     this disease.      The purpose of this study is to determine the effectiveness of treatment with     sulfamethoxazole-trimethoprim for 6-12 weeks in children suffering from chronic otitis media     and otorrhea.   "
178969|NCT00189111|"     The purpose of this study is to find out if subjecting cardiac high risk patients to non     invasive cardiac imaging, followed by treatment will improve survival and quality of life   "
178970|NCT00189124|"     The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in     patients with systemic lupus by measuring:        1. changes in brachial artery flow-mediated dilatation (FMD) and        2. changes in biomarkers of cardiovascular risk. Patients will be enrolled in a randomized,          double-blinded crossover trial of DHEA or placebo for ten weeks, then crossed over to          the alternate treatment arm after a six-week washout period.      HYPOTHESIS: Dehydroepiandrosterone (DHEA) administration in premenopausal women with SLE     modifies cardiovascular risk by improving vascular endothelial function and other biomarkers     associated with cardiovascular heart disease.   "
178971|NCT00189137|"     The purpose of this study is to explore how a sarcoma is affected by and the side effects of     a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard     combination of chemotherapy drugs, ifosfamide and doxorubicin.   "
178972|NCT00189150|"     The primary objective of this study is to determine whether a clinically significant PK drug     interaction ( a 30% difference in the AUC of MPA) exists between mycophenolate mofetil (under     steady state conditions) and VGCV in renal and cardiac transplant recipients.      This study will provide clinically relevant information to the transplant community. It will     more clearly delineate whether a clinically significant PK drug interaction exists between     mycophenolate mofetil (under steady-state conditions)and VGCV. Given the established     dose/efficacy relationship of both MMF and VGCV, this study will provide improved dosing     guidelines and potentially avoid adverse outcomes due to empiric dosage adjustments.   "
178973|NCT00189163|"     The presence of insulin resistance (IR) appears to be a key factor in the development of     steatosis and disease progression in patience with Hepatitis C virus (HCV) genotype-1     infections similar to levels in Non-alcoholic fatty liver disease (NAFLD). The objective of     this study is to determine whether Pioglatizone, when given along with Interferon and     Ribavirin, reduces insulin resistance and lowers HCV viral levels and improved response in     patients who have HCV genotype-1 infection when compared to a placebo.   "
178974|NCT00189176|"     This study will evaluate the safety of the administration of a copper chelating agent,     tetrathiomolybdate, for patients with idiopathic pulmonary fibrosis that have failed previous     treatment. The primary endpoint for this study is safety with secondary endpoints including     change in pulmonary function, exercise capacity, and quality of life.   "
178975|NCT00189189|"     Oppositional defiant and conduct disorders are the most frequent bases for referral of     children and adolescents. These disorders are difficult to treat among school-aged children     and adolescents. When they become adults they are likely to manifest depressive disorders,     substance abuse or dependence, and criminal behavior. These disorders are also two of the     costly childhood disorders. The aim of the study is to assess the preventive effect of parent     management training in preschool children at risk for oppositional defiant and conduct     disorders because of high aggression scores on a parent questionnaire. It is hypothesized     that given the relatively restricted costs of the intervention and the substantial costs of     burden associated with these children, the intervention will be cost saving.   "
178976|NCT00189202|"     African Americans receiving a kidney transplant are considered at high risk for early     rejection of their transplanted kidney and require more immunosuppression to maintain their     kidney transplant function. This increase in immunosuppression puts this group at risk for     drug-related toxicities and complications such as post-transplant diabetes.      This study will evaluate:        1. Whether a sirolimus based steroid avoidance regimen in African Americans may decrease          the risks of drug-related toxicities,        2. Decreased rates of metabolic complications such as post-transplant diabetes,        3. The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.   "
178977|NCT00189215|"     Coronary artery bypass surgery is associated with postoperative cognitive decline, which has     largely been attributed to the use of the heart lung machine. We hypothesized that long-term     cognitive outcome may improve by avoiding the heart lung machine. The objective of the     present study is to compare the effect of coronary bypass surgery with and without heart lung     machine on cognitive and clinical outcome, five years after surgery.   "
178978|NCT00189228|"     We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.   "
178979|NCT00189241|"     The purpose of this study is to evaluate the long-term sustained clearance rate of     superficial basal cell carcinoma during a 5 year period following treatment with imiquimod   "
178980|NCT00189254|"     The purpose of the study is to obtain recurrence rates and long-term safety data for patients     who had been treating actinic keratoses on the face and scalp with 5 % Imiquimod Cream in a     previous study.   "
178981|NCT00189267|"     The purpose of the study is to compare effectiveness and safety of multiple applications of     imiquimod 5% cream and vehicle cream in graft recipients suffering from actinic keratosis.   "
178982|NCT00189280|"     BCC is the most common form of skin cancer. Current treatment is often surgery but this can     be limited by the number of lesions, their location the age of the patient or the potential     cosmetic outcome. The purpose of this study is to evaluate the effectiveness of imiquimod, on     a non surgical treatment, in subjects with multiple of large sBCCs.   "
178983|NCT00189293|"     The purpose of this study is to compare the recurrence rate following total clearance of     external genital warts (EGWs) when clearance has been obtained by imiquimod (3 applications     per week for 4 weeks) followed by ablative therapy (laser or electrocautery therapy) with     that from just ablative therapy treatment alone.   "
178984|NCT00189306|"     An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied     topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of     follow-up.   "
178985|NCT00189319|"     The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation     with controlled release flecainide on patient's quality of life.   "
178986|NCT00189332|"     Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week     for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.   "
178987|NCT00189345|"     Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive     surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance     of entering complete clinical remission but about 70% will eventually relapse. Many patients     respond to additional cytotoxic treatment with partial or complete responses, yet     approximately 100% of these patients will ultimately progress. Novel consolidation strategies     following treatment for recurrent disease are needed and an immunologic approach is an     attractive option.EpCAM is expressed in a large number of epithelial ovarian cancer,     fallopian tube or peritoneal cancer tissues. Thus targeting these cancers with an anti-EpCAM     antibody is a promising innovative therapeutic approach.   "
178988|NCT00189358|"     Although initially responsive to cytoreductive surgery and platinum- and/or taxane-based     chemotherapy, a majority of patients with epithelial ovarian cancer, cancer of the fallopian     tube or the peritoneum will eventually relapse. Recurrence within 6 months after completing     platinum-containing chemotherapy indicates a platinum-refractory cancer disease. New     therapeutic strategies are required in platinum-refractory disease. Inhibition of growth     signals induced by the epidermal growth factor receptor pathway, or by the estrogen receptor     pathway provides promising targets in epithelial ovarian cancer, cancer of the fallopian tube     or the peritoneum. The trial is to evaluate the safety and tolerability of the combination of     the epidermal growth facto tyrosine kinase inhibitor ZD1839 and the clinically established     antiestrogen tamoxifen.   "
178989|NCT00189371|"     Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive     surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance     of entering complete clinical remission but about 70% will eventually relapse. Relapse more     than 6 months following first line chemotherapy is regarded as platinum/taxane sensitive     disease. Reinduction chemotherapy with platinum/taxane is known to be an effective treatment     option. Therapy induced anemia is a common problem resulting in decrease of quality of life.     The rationale of this trail is to evaluate the effects of epoetin alpha on reduction of     therapy induced anemia, rate of transfusions and on quality of life.   "
178990|NCT00189384|"     Approximately one-third of neonatal deaths in developing countries are due to infections     acquired through the birth canal and/or exposure to an unclean environment soon after birth.     Current World Health Organization recommendations for the management of infants younger than     2 months of age who have serious bacterial infections involve hospitalization and parenteral     therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin     combined with an aminoglycoside.However, in many settings throughout the developing world,     this is not currently possible, nor is this standard of care likely to be feasible in the     near future. Several studies have reported that for a variety of sociocultural reasons many     families are unable or unwilling to access hospital-based care and their sick young infants     do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies,     or none at all. In our community field sites, approximately 70% of families refuse hospital     referral for a sick newborn, despite provision of transport.      Thus, there is an urgent need to define the role of community/first-level facility-based care     versus hospitalization for the management of young infants with serious bacterial infections,     and the potential for community-based parenteral antibiotics as an alternative strategy in     resource poor areas with high neonatal mortality rates. Bang and colleagues have demonstrated     significant reductions in neonatal mortality from infections in an underdeveloped rural     district in Maharashtra, India by a field-based case management approach which used oral     cotrimoxazole and intramuscular gentamicin given for 7 days as treatment for neonates with     sepsis.      This study is an equivalence randomized controlled trial (RCT) comparing once daily IM     ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once     daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7 days     in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or     sepsis with or without local infections such as skin or umbilical infections) whose families     refused referral to a hospital. After supplementary informed consent, patients meeting     specific inclusion and exclusion criteria are randomly allocated to one of the three regimens     being tested. The study hypothesis is that all 3 regimens will perform equally well in the     treatment of sepsis in a first-level facility setting.   "
178991|NCT00189397|"     The dermatitis caused by the substances which come in contact with the skin is known as     contact dermatitis. When such a reaction is caused by the agents suspended in the air, it is     called air-borne contact dermatitis (ABCD). Parthenium hysterophorus at present is the     commonest cause of ABCD in India though in some cases other plants have also been found to     cause ABCD. Parthenium dermatitis is one of the major health problems in dermatology in our     country. Though it has very little mortality, the disease normally continues to persist with     variable remissions and relapses causing great distress and morbidity. Corticosteroids,     topical and systemic have been the mainstay of the treatment so far. Therefore, the patients     with ABCD who have to take corticosteroids for long periods of time tend to develop severe     and sometimes irreversible side effects of the therapy. Azathioprine is an immunosuppressive     drug which acts by inhibiting the T lymphocytes. In our previous studies we have been able to     induce remissions in these patients with azathioprine used as daily as well as monthly bolus     dose, without having to use systemic corticosteroids. The side effect with azathioprine in     these studies were almost absent.      We have therefore planned to study the therapeutic efficacy of azathioprine weekly pulse     doses versus daily azathioprine in achieving remissions in patients having Parthenium     dermatitis and to monitor the side effects of both the regimens.   "
178992|NCT00189410|"     Pegylated Liposomal Doxorubicin as well as Carboplatin have been showed efficacy in     monotherapy as in combination therapy of gynaecologic tumours. As there is no common standard     in the therapy of recurrent ovarian carcinoma, tumours of the uterus nor for non-epithelial     ovarian tumours at time of designing of this study, this trial shall evaluate the new and     well tolerated combination therapy consisting of Pegylated Liposomal Doxorubicin and     Carboplatin.   "
179013|NCT00189683|"     To compare maintenance chemotherapy with Xeloda to control after best response with first     line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival.     A total of 300 patients will be included.   "
178993|NCT00189423|"     The purpose of this study is to determine whether performing active compression decompression     cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD) compared to     conventional standard cardiopulmonary resuscitation (S-CPR) will impact the neurologic     recovery and survival to hospital discharge following out-of-hospital cardiac arrest.   "
178994|NCT00189436|"     Subjects aged 1-8 years who have been discharged from the emergency department/outpatient     care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will     be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of     nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates     during the 21-day follow-up period.   "
178995|NCT00189449|"     Seasonal/perennial allergic rhinitis (SAR/PAR) is a common childhood illness. One of the     leading therapies for the treatment of SAR/PAR is intranasally inhaled corticosteroids (ICS).     One of the major long-term safety concerns is whether ICS interferes with normal growth in     allergic rhinitis children. Recent evidence suggests that nasal ICS may cause decreased     growth. However, the effect of nasal ICS on long-term growth and the attainment of final     adult height is unknown. Another potential systemic adverse effect of ICS use is suppression     of the hypothalamic-pituitary-adrenal axis function. The primary hypothesis of this study is     that triamcinolone acetonide aqueous nasal spray (TAA) will have no effect on measured adult     height in relation to target adult height in children with allergic rhinitis.   "
178996|NCT00189462|"     The objective of this pilot study is to evaluate the efficacy of treatment with montelukast     as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)   "
178997|NCT00189475|"     Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for     the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50     years.   "
178998|NCT00189488|"     The main purpose of this study is to evaluate the effect of palifermin versus placebo in the     reduction of severe acute graft versus host disease (GVHD) and severe oral mucositis.   "
178999|NCT00189501|"     Objectives include description of current practices; assessment over time of K/DOQI goals,     clinical outcomes, health resource utilization(HRU) and patient reported outcomes (PRO) and     the impact of Sensipar® on these parameters   "
179000|NCT00189514|"     This is a long term extension to study 137OB-201 which is designed to examine the effect of     pramlintide on body weight and its safety and tolerability in obese subjects.   "
179001|NCT00189527|"     Noninvasive ventilation is a therapeutic option in some patients with chronic respiratory     failure. Patients usually ventilate during nightime with a domiciliary ventilator either in     assist control or in pressure support mode.      The aim of this study is to compare the clinical efficacy and the tolerance of assist control     and pressure support modes during domiciliary noninvasive ventilation in patients with     chronic respiratory failure.   "
179002|NCT00189540|"     The objective of this study is to test the hypothesis that AMG0001 treatment is safe and     induces angiogenesis as detected by improved wound healing, reduction in amputation, improved     pain at rest and hemodynamic measurement and to assess the effectiveness of the     administrative method.   "
179003|NCT00189553|"     This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in     combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin     in patients with epithelial ovarian cancer in late relapse (> 6 months).   "
179004|NCT00189566|"     This study will look at the efficacy and safety of weekly administration of paclitaxel     (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin     in patients with ovarian cancer in early relapse.   "
179005|NCT00189579|"     The purpose of this study is to evaluate whether or not the addition of Herceptin may be of     benefit to a standard regimen of carboplatin-paclitaxel.   "
179006|NCT00189592|"     The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for     relieving pain associated with recurring plantar fasciosis and, secondarily, to determine     whether there may be additional potential benefits stemming from its use.   "
179007|NCT00189605|"     The goal of this post-marketing surveillance study is to compare two procedures which are     used to treat patients who require a disc decompression procedure. These procedures are: 1)     plasma disc decompression procedure using Coblation technology and 2) fluoroscopy guided     transforaminal epidural steroid injection (TFESI). The study will evaluate treatment efficacy     and rate of improvement in symptoms through the first six months following the procedure.      The principal objectives of this study are to determine whether subjects receiving the plasma     disc decompression procedure demonstrate:        1. Improved clinical outcomes over subjects receiving TFESI        2. More rapid reversal of symptoms than subjects receiving TFESI   "
179008|NCT00189618|"     To evaluate the change in walking capacity after a well organized and structured intensive     physical training program with supportive pharmacotherapy with Clopidogrel or ASA. It is     hypothesized that statistically superior results will emerge from a structured training     supported by Clopidogrel as compared to a structured training supported by ASA.   "
179009|NCT00189631|"     To compare maintenance therapy to observation in metastatic breast cancer patients responding     (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival.     Secondary endpoints are overall survival and tolerance. A total of 200 patients will be     included.   "
179010|NCT00189644|"     The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in     patients with resected node positive breast cancer. Main endpoint is disease free survival.     Secondary endpoints are overall survival, time to local recurrence, time to distant     metastases, and tolerance. A total of 840 patients have been included in the trial.   "
179011|NCT00189657|"     The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or     LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative     radiotherapy is recommended but not mandatory. Main endpoint is disease free survival.     Secondary endpoint are overall survival, time to local recurrence, time to distant     metastases, and tolerance. A total of 600 patients will be included in the trial.   "
179012|NCT00189670|"     To screen a dose-dense arm to be used in a future large scale phase III trial. Primary     endpoint is safety; secondary endpoints are disease free survival and overall survival. A     total of 100 patients were included.   "
179024|NCT00189826|"     To evaluate and to compare efficacy and safety of a dual regimen with oral modified release     tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 /     steroids in patients undergoing primary liver transplantation. It shall be demonstrated that     FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.   "
179025|NCT00189839|"     The purpose of this study is to evaluate and to compare the efficacy and safety of a triple     modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard     tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It     shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary     endpoint.   "
179026|NCT00189852|"     The primary objective of this project is to investigate whether, in a pilot randomised     controlled trial, the use of telecare (remote monitoring) technologies reduces the frequency     of hospital admissions for people with chronic heart failure (CHF) and to inform the design     of a larger randomised controlled trial of telecare for CHF.      Secondary objectives are:        1. To investigate whether there are benefits to users        2. To understand the impact on carers in terms of carer stress        3. To investigate whether there are benefits to the NHS and other statutory provisions        4. To investigate which users receive the greatest benefits        5. To inform whether remote monitoring of CHF patients should be provided as part of          hospital discharge for a set period of time or whether it should be provided long term          and be used in a preventative manner        6. To investigate whether CHF episodes can be detected and predicted based on lifestyle          changes        7. To determine whether lifestyle monitoring equipment can be correlated with the          information from the CHF monitoring system to determine the potential to detect          deteriorating health.   "
179027|NCT00189878|"     The purpose of this study is to determine whether methotrexate produces significant     improvement in chronic idiopathic urticaria, compared with placebo   "
179028|NCT00189904|"     The purpose of this study is to gather information on the safety and immunogenicity of an     investigational smallpox vaccine in HIV infected populations.   "
179029|NCT00189917|"     The purpose of this study is to gather information on the safety and immunogenicity of an     investigational smallpox vaccine in populations with atopic disorders.   "
179030|NCT00189930|"     The objective of the study is to compare two doses of MVA-nef vs. MVA-BN to induce     Nef-specific cellular immune response in HIV-1 infected patients   "
179031|NCT00189943|"     The purpose of this study is to collect information on the safety, tolerability and     immunogenicity of an investigational smallpox vaccine at different doses and using different     routes of administration in vaccinia-naive and vaccinated healthy volunteers   "
179032|NCT00189956|"     The objective of the study is to find the optimal dose for the smallpox candidate vaccine     IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at     three different dose levels.   "
179033|NCT00189969|"     The purpose of this study is to assess the take rate (formation of a typical postvaccinal     lesion)and the safety and immunogenicity of the smallpox vaccine Elstree-BN.   "
179034|NCT00189982|"     The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the     treatment of children with hemophilia A. The study is open to pediatric patients in Canada     who completed Baxter Study 060101.   "
179035|NCT00189995|"     Aggressive, persistent aggression and impulsive behavior are frequently observed in     schizophrenic patients. According to some researchers more than 50% of all psychiatric     patients and 10% of schizophrenic patients show aggressive symptoms varying from threatening     behavior and agitation to assault(1). It is a common cause of psychiatric admission and is a     therapeutic issue. The treatment of these symptoms is a clinical problem for both patients     and staff. Violent behavior, a major detrimental factor in stigmatization of the mentally     ill, also poses physical danger for the patients themselves. Current pharmacotherapy of     pathologic aggression involves the use of multiple agents (typical and atypical     antipsychotics, benzodiazepines, mood stabilizers, beta-blockers, antiandrogenic hormones,     and selective serotonin reuptake inhibitors) on empiric basis, with varying degrees of     response (2-6). Unfortunately, these approaches lead to numerous side effects. Poor or     noncompliance with pharmacotherapy makes it difficult to choose the appropriate preparation.     Currently, typical neuroleptics are still the first choice in treating acute aggressive     symptoms, while risperidone and olanzapine could be alternatives (5-7). Typical depot     neuroleptics should be considered in cases where medication compliance is a problem. Most     clinical information on treating of aggression has been collected about atypical     neuroleptics, particularly regarding clozapine.      Clozapine is indicated in psychotic state and/or in drug-resistant schizophrenic patients.     According to the FDA - it is the drug of choice in suicidal and aggressive patients, due-to     psychotic state. It was found helpful in nearly 30% of resistant schizophrenic patients.     Concerning the parenteral administration of clozapine - very little data is available today.      This study aims to investigate efficacy and safety (psychopathology, and side effects) of     parenteral clozapine in treatment of aggressive behavior in schizophrenic patients in a     double-blind trial.   "
179036|NCT00190008|"     The mechanism involved in the development of tardive dyskinesia (TD) is complicated. It now     seems that several neurotransmitter systems may be affected, including dopaminergic,     noradrenergic, gamma-amino-butyric acid (GABA) ergic, cholinergic and peptidergic pathways.      Piracetam (2-oxo-pyrrolidone) is a nootropic drug structurally related to GABA. It has been     used clinically to treat a wide range of diseases and conditions, mainly in treatment of     organic brain syndrome, myoclonus, memory impairment, post-concussional syndrome, vertigo,     alcohol withdrawal, cerebrovascular insufficiency, hypoxia, intoxications of different     origins or mechanic brain injures. Piracetam is cerebral homeostatic normalizer,     neuroprotectant, cerebral metabolic enhancer and brain integrative agent. It enhances brain     energy, especially under deficit condition: hypoxia, chemical toxicity or impaired cerebral     microcirculation; preserve, protect and enhance synaptic membrane and receptor structure and     plasticity. It has various effects on glutamate neurotransmission on micromolar levels     piracetam potentiates potassium-induced release of glutamate from hippocampal nerves. It is     an oxidant agent and may be useful for treatment TD. Piracetam is among the toxicologically     safest drugs ever developed even in mega doses.      Data derived from some clinical reports have suggested that piracetam can improve symptoms     and is effective agent for treatment of different movement disorders including acute     neuroleptic induced extrapyramidal symptoms and TD. The doses that used for TD treatment     varied from 800 mg/day to 24000 mg/day. According to these findings the symptoms of TD     disappeared in the period of 3-7 days.      To date there was only one double-blind crossover study regarding use of piracetam for     treatment TD that was conducted almost 20 years ago. The findings of this study were     impressive, but to our knowledge nobody reproduced these results.   "
179052|NCT00190216|"     The hypothesis of this study was that transcranial magnetic stimulation (TMS) focused on     hyperfunctional cerebral areas should be more effective in treating depressive symptoms than     stimulations not taking into account the functional specificity of the patient. The goal was     to compare the effects of guided TMS, using neuroimaging to guide TMS on dysfunctional     cortical regions individually detected by neuroimaging, with standard TMS, as used in most     studies, over the left prefrontal cortex, and with sham TMS, in patients with resistant     depression.   "
179055|NCT00190255|"     Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the     use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for     the elimination of several NSAIDs. This protein is inactive in 12% of the subjects because of     genetic mutations. We hypothesized that individuals carrying such mutations should be at     higher risk of gastrointestinal bleeding since they display decreased NSAIDs elimination.   "
179037|NCT00190021|"     Conventional psychotropic medications may be used to treat behavioral disturbances and     psychotic symptoms in patients with dementia and they are the drugs of choice for treating     delusions and hallucinations. However the sensitivity to side effects in these patients often     restricts the use of these agents (2, 3). Although, atypical antipsychotics have some     advantages compared with conventional neuroleptics, they also are associated with side     effects (5, 6).      Cholinesterase inhibitors (ChEIs) enhance neuronal transmission by increasing the     availability of acetylcholine in muscarinic and nicotinic receptors. According to findings of     some researchers ChEIs have psychotropic effects and may play an important role in     controlling neuropsychiatric and behavioral disturbances in patients with Alzheimer's disease     (7-10). These agents may also contribute to the management of other disorders with     cholinergic system abnormalities and neuropsychiatric symptoms such as visual hallucinations     (11).      Donepezil is a piperidine-based reversible, noncompetitive ChEI, which is indicated in the     management of patients with Alzheimer's disease of mild to moderate severity (12-14).     Preliminary observations suggest the possible value of ChEIs in the amelioration of psychotic     symptoms in patients with dementia of the Alzheimer's type (DAT), dementia with Lewy bodies     and patients suffering from Parkinson's disease (11-18).      The results of our study (18) indicate that the addition of donepezil to perphenazine     resulted in qualitatively superior clinical gains compared to higher doses of neuroleptic     therapy without donepezil.      The finding of the pilot study although impressive, stem from data regarding a rather small     sample. The present (second) phase of the study will include a larger sample of patients. We     now intend to examine 80 inpatients, aged 65-90 years old, suffering from DAT.   "
179038|NCT00190034|"     The purpose of this study is to determine whether N-acetylcysteine is effective in the     prophylaxis of post-cardiopulmonary bypass acute renal impairment.   "
179039|NCT00190047|"     This study will examine if DP-b99 can improve neurological function (for example strength and     coordination) in the 3 months after an acute stroke   "
179040|NCT00190060|"     The study aims to determine the effects of testosterone on muscle function, mobility,     activities of daily living and overall quality of life   "
179041|NCT00190073|"     Peripheral neuropathy is a frequent neurological complication of chronic alcoholism. Most     studies evaluated large-fiber involvement by nerve conduction studies (NCS). Since previous     studies document the predominant injury of small myelinated and unmyelinated fibers in     patients with alcoholic neuropathy, it will be imperative to know their prevalence and     clinical significance. Moreover, the pathogenesis of alcoholic neuropathy, especially the     roles of ethanol and its metabolites and thiamine, remains elusive. This proposal will be     designed to understand the extent and clinical significance of cutaneous nerve degeneration     in the skin of alcoholic patients and to investigate its pathogenesis. We will investigate     cutaneous innervation by 3 mm punch skin biopsies with immunohistochemistry for protein gene     product 9.5 and quantifying epidermal nerve density (END) in alcoholic patients. Patients     will undergo clinical evaluation, quantitative sensory testing (QST), nerve conduction     studies (NCS), and tests of sympathetic skin response (SSR) and beat-to-beat RR interval     variability (RRIV). The prevalence of peripheral neuropathy in chronic alcoholic patients     with emphasis on small-fiber involvement will be first evaluated. The sensitivity of punch     skin biopsy, QST, SSR and RRIV tests, and NCS will be compared, and the correlations between     END and psychophysic and electrodiagnostic parameters will be discussed. Subsequently, we     will elucidate the clinical significance of END reduction in alcoholic patients. Patients     with evidences of involvement of central nervous system will be excluded, and END will be     correlated with clinical manifestations and neurological deficits. Finally, the role of     ethanol and thiamine in alcoholic neuropathy will be further studied. To clarify the role of     thiamine in alcoholic neuropathy, we will examine whether it has influences on small-fiber     degeneration. This may provide important information in understanding the pathogenesis and     designing optimal treatment for alcoholic neuropathy.   "
179042|NCT00190086|"     Cardiac syndrome X is characterized by angina, positve stress test, and patent coronary     angiography, and its probable mechanism is microvascular dysfunction associated with     endothelial dysfunction. We used brachial artery flow-mediated vasodilation to assess the     endothelial function of the patients with syndrome X, coronary artery disease, and controls.     Methods: We enrolled 28 patients with syndrome X, 11 healthy volunteers and 11 coronary     artery disease patients. All subjects underwent a 2-step brachial artery flow-related     vasodilation test: ultrasound artery diameter was measured at rest and after occlusion to     assess endothelium-dependent vasodilation and after sublingual nitroglycerin to determine     endothelium-independent condition. Serum endothelin-1 assay was performed for all     participants. Results: The cardiac syndrome X patients had lower brachial artery dilation     ratio (diameter after test/ diameter before test) than controls (1.10 +/- 0.09 versus 1.27     +/- 0.11, p=0.013), but the ratio is still higher than CAD patients (1.10 +/- 0.09 versus     1.02 +/- 0.07, p<0.001). After sublingual nitroglycerin, all 50 subjects had adequate     vasodilation. Besides, normal controls have higher endothelin-1 level than the others.      We concluded that syndrome X patients have worse endothelial function than healthy control,     but patients of CAD had even worse endothelium function than cardiac syndrome X patients.      Keywords: Cardiac syndrome X, coronary artery disease, endothelium-dependent vasodilation,     endothelium-independent vasodilation, flow-mediated vasodilation, endothelin-1   "
179043|NCT00190099|"     The major obstacle of the long- termed success of percutaneous coronary intervention (PCI) is     the restenosis. Restenosis results from complex pathophysiological response of the vascular     tissue to the balloon injury. In the pre-stent era, 80% of it was attributed to vascular     recoil. However, by way of the mechanical support of metallic stent, recoil is no more the     major reason of restenosis. About 80 % of In-stent restenosis resulted from intimal     hyperplasia.      The mechanism of the Intra-stent restenosis included 4 stages. First stage comprised the     first 3 days after balloon injury, when the inflammatory reaction is most severe throughout     the course. At that time, anti-inflammatory drug as steroid wuold be helpful to prevent the     course of restenosis. Until the end of the third week, smooth muscle cells migrate and then     proliferate in the second and the third stage, and the key effort to prevent restenosis right     now is inhibition of cell cycle. Intravascular radiotherapy (so called Brachytherapy) and     stent-based drug elution target upon them. Among them, rapamycin and paclitaxel proved to be     effective both in animal and human experience. The last stage is re-epithelization, estrogen     could promote the process and was considered to be effective in this stage.      Stent-based elution of corticosteroid, despite of its feasibility and safety, was not as     effective as other anti-proliferation agent ( eg. Rapamycin etc). The major reason might be     the patient group with coronary artery disease is a heterogenous one.      We believe if we applied corticosteroid over the patient with elevated inflammatory     parameters, i.e. acute coronary syndrome (ACS) the effect of anti-restenosis would be     obvious.      In this study, by a special-designed, phosphorylcholine-coated stent, dexamethasone could be     readily absorbed and then gradually released locally even 4 weeks after deployment.      We expected a reduction of In-stent restenosis in ACS patient by the method with no or few     systemic adverse effect of steroid; and angiographic follow-up as well as intra-vascular     ultrasound assessment would be performed according to pur protocol.   "
179053|NCT00190229|"     Henoch-Schonlein purpura is a leucocytoclastic systemic vasculitis involving small vessels     with the deposition of immune complexes containing IgA. It is characterized by the     association of skin, joint and gastrointestinal manifestations. Even though the evolution is     usually simple, some patients, especially adults, may have severe visceral involvement     including heart, lung, brain and renal disease. The best treatment is currently unknown. This     study will test the safety and efficacy of steroids associated or not with cyclosphosphamide     to treat the acute lesions and to prevent the development of chronic lesions.   "
179054|NCT00190242|"     Immunogenicity is reduced in immunocompromised patients. The aim of this prospective     randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of     anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3,     co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will     be evaluate.   "
179044|NCT00190112|"     Atrial fibrillation (Af) is the most common morbid event after open heart surgery. Its     incidence ranges from 19% to 27%, as reported by the Society of Thoracic Surgeons database.     Many groups have tried to understand and treat this difficult problem and have formulated     different hypotheses to explain its origin. An imbalance of the autonomic nervous system     after surgical intervention has been accepted as a major determinant for this morbidity.     Ventral cardiac denervation is a fast and low-risk procedure. This intervention has shown     significantly reduction of the incidence and severity of Af after routine coronary artery     bypass surgery. This technique could be applied both on-pump or off-pump and used as an     adjunctive procedure to achieve Af prophylaxis. However, the detailed mechanism remains     unclear. Theoretically, heart receives its innervation from the autonomic nervous system     (ANS) via the great vessels and pericardial attachment. The propensity and distribution of     ANS nerve fibers are different in location. In this study, we would like to evaluate the ANS     function after ventral cardiac denervation by using heart rate variability (HRV) and     baroreflex (BRS) sensitivity. 30 patients proposed to have elective off-pump coronary artery     bypass surgery are enrolled. After induction of anesthesia, the depth of anesthesia is     controlled by inhalation agents and monitored by bispectral index. After the major cardiac     operation, ventral cardiac denervation is performed by using electrocautery. The digital     signals of heart rate and blood pressure are acquired before and after the surgical     procedures under the same range of bispectral index (50~60). The paired HRV and BRS are     analyzed. This will provide us more information to justify the procedure.   "
179045|NCT00190125|"     The purpose of this study is to explore the severity of malnutrition and inflammation in     Taiwanese hemodialysis patients.   "
179046|NCT00190138|"     Patients with congestive heart failure are often associated with delayed intraventricular     depolarization which causing dyssynchrony and an inefficient pattern of left ventricular     contraction. A number of studies have shown that bi-ventricular or left ventricular pacing     improves indexes of systolic function as well as decreases sympathetic activation in patients     with severe left ventricular systolic dysfunction, dilated cardiomyopathy and a major     left-sided intraventricular conduction disorder such as left bundle branch block. One recent     study also demonstrated that bi-ventricular pacing can shift heart rate variability (HRV)     toward a more favorable profile. Baroreflex sensitivity (BRS) is a measure of the negative     feedback properties that interact in modulating the dynamic heart rate and arterial pressure     fluctuations. Blunted BRS is found to be associated with an increased risk for both cardiac     deaths and arrhythmic events. However, the effect of bi-ventricular pacing on BRS has never     been studied. In the present proposal, we plan to measure common hemodynamic parameters, BRS     and HRV in a group of heart failure patients receiving open heart surgery in different pacing     conditions (bi-ventricular pacing, single LV pacing, single RV pacing). The major aims are to     investigate the effect of bi-ventricular pacing on BRS and to clarify the underlying     mechanisms.   "
179047|NCT00190151|"     Bacterial resistance to antibiotics has been a growing therapeutic problem since the late     1980s. Resistant strains of pathogenic bacteria can arise through initial selection of     resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the     commensal flora will be assessed in 48 healthy volunteers receiving variable doses of     ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic     characteristics of ciprofloxacin.   "
179048|NCT00190164|"     Rational of the study: There are arguments to think that the closure of macular holes can be     obtained without a strict positioning under certain conditions, i.e. hole size ≤ 400 µm, if     the patient avoids the position laid down on the back. In order to be able to confirm these     observations, it is necessary to make a randomized study with an adequate number of patients.      Aim of the study: To show that the percentage of success (anatomical closure confirmed by     OCT) is not lower in the group without positioning.      Tested Hypothesis: The absence of strict positioning is at least as effective on the     success of the surgery of small macular holes as the imposition of a strict positioning.      Expected results: To show that the success rate of the surgery of the idiopathic macular     holes of 400 µm or less is not decreased by the replacement of a strict positioning     (face-down 22h/24) by a simple instruction of avoiding the position laid down on the back,     thus avoiding the patients this painful part of the treatment and allowing a reduction in the     duration of hospitalization and consequently a reduction in the cost of the treatment.   "
179049|NCT00190177|"     The study hypothesis is the involvement of the couple CX3CR1/CX3CL1 in occurrence of     endothelial injury in preeclampsia. According to this hypothesis, Carriers of the I249 allele     who express less CX3CR1 shoud be protected against this risk. The main objective of the study     is the search of an association between CX3CR1 V249I polymorphism and preeclampsia. The     secondary aims are the search of an association with the most severe forms of preeclampsia     and endothelial injury.   "
179050|NCT00190190|"     Rational of the study: for macular holes larger than 400 µm the rate of failure is of more     than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting     membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of     this gesture, it is necessary to make a randomized study.      Primary objective: To show that the percentage of success (anatomical closing, confirmed by     OCT) at third postoperative month is higher in the ILM peeling group.      Design of the study: Randomized multicentric study, in parallel groups, with individual     benefit for the patient.      Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than     400 µm is increased by the peeling of the MLI.      Awaited results: To show that the success rate of the surgery of idiopathic macular holes     larger than 400 µm is improved by ILM peeling. This category could then have a success rate     similar to the small holes. If this difference is not proven, it will remain no justification     to continue this procedure which represents little risk but which is not either without     consequence.   "
179051|NCT00190203|"     The purpose of this study is to determine if patients with malignant middle cerebral artery     infarction have a better clinical outcome after early decompressive surgery compared to     standard medical management.   "
179177|NCT00180362|"     The purpose of this study is to evaluate the strategy of implanting an ICD with or without     EPS before, during and after ICD-implantation in a randomised controlled trial, using a     combined endpoint of major ICD-related adverse events as the primary outcome measure.   "
179056|NCT00190268|"     Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in     patient's multiple sclerosis.      In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded     study is performed.   "
179057|NCT00190281|"     To evaluate the changes in the microcirculation of the liver, kidney and spleen during acute     infection in patients with malaria (cohorts 1 and 3) and other infectious diseases such as     acute pyelonephritis at day 0 (within 8 hours of the treatment start), day 2 to 4 and day     28-32, using functional US with continuous infusion of a contrast agent (SonoVue, Bracco,     Italy).      Study hypothesis: malaria patients should exhibit a different pattern of enhancement,     particularly when quantitative measurements of the SU signals is performed with destruction     reperfusion kinetics.   "
179058|NCT00190294|"     Compared the interest of one week expectancy vs immediate medical treatment in the taking     care of the evacuation of the no evolutionary pregnancies before 13 GW.   "
179059|NCT00190307|"     The STRATAGEM trial is an investigator-driven French nationwide multicenter, randomized,     double-blind, placebo-controlled trial comparing perioperative low-dose aspirin therapy     versus placebo in the perioperative period in patients with documented symptomatic stable     atherothrombotic disease taking antiplatelet therapy and undergoing non-coronary surgery.   "
179060|NCT00190320|"     Aim of the study :The major aim is to evaluate the effectiveness of the induction of labor in     case of fetal macrosomia on the reduction of neonatal traumatism risk. The secondary aims are     to evaluate maternal morbidity and the risk of Caesarean in case of induction of labor,     compared to a spontaneous labor.   "
179061|NCT00190333|"     This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study to     evaluate the efficacy of escitalopram (30 mg/day) in two parallel groups (randomization     ratio, escitalopram 2/placebo 1).   "
179062|NCT00190346|"     Comparison of humidification devices during non invasive ventilation, in acute respiratory     failure.      The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the     technique (NIV) when HME are used in comparison with HH.   "
179063|NCT00190359|"     Heart failure induces modification in several neurohormonal systems. The aim of this study is     to determine if the growth hormone/IGF1 axis is modified in heart failure patients compared     to healthy volunteers.   "
179064|NCT00190372|"     The aim of the project is to demonstrate that a psycho-educational programme designed to     support and train carers of Alzheimer's disease (AD) patients induces a significantly higher     benefit than anticholinesterase drug treatment alone or associated to memantine treatment.     This training programme focuses on the explanation/description of behavioral, cognitive and     functional disorders induced by the disease, as well as principles of cognitive and     psycho-social stimulation of the patients in daily life.   "
179065|NCT00190385|"     Liver carcinoma is becoming the main complication of cirrhosis. Treatment of symptomatic or     large tumors is disappointing. Regular ultrasonographic screening of small (curable) tumors     is currently recommended, but the best periodicity is unknown.This randomized trial is aimed     to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.   "
179066|NCT00190398|"     The purpose of this study is to evaluate whether carotid angioplasty with stent (CAS) is as     safe and effective as carotid surgery in regards to:        1. the risk of stroke and death within 30 days of the procedure;        2. the long-term risk of ipsilateral carotid territory stroke, in patients with recently          symptomatic, severe carotid stenosis suitable for both CAS and carotid endarterectomy.   "
179067|NCT00190411|"     Ehlers-Danlos syndrome vascular type (EDS-IV) is caused by a genetic defect of collagen type     III. Patient die (median 40 yrs) of vascular complications. There is no treatment. We showed     that arteries are thin and overloaded in this patients. We test the protective effect of     celiprolol on cardiovascular events in a 5 years, randomized, PROBE design   "
179068|NCT00190424|"     The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is     effective in the treatment of glioblastoma   "
179069|NCT00190437|"     Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung     disease (COLD) is a major cause of morbidity and mortality in such patients. Although     bacterial of mortality in such patients. Although bacterial and or viral infections are     considered as the major precipitating factor, the antibiotic strategy in this setting is     unclear. The absence of overt infection remains controversial, and has not been adequately     studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine     early systemic antibiotic therapy in patients with COLD admitted to the ICU.      The primary objective of the essay is to evaluate the effectiveness of the precocious     antibiotic therapy on the length of the respiratory symptoms with the admitted patients in     polyvalent medical intensive care of chronic obstructive lung disease ( COLD )   "
179070|NCT00190450|"     The aim of this study is to show the existence of a clinical benefit rising from a     substitution of the striatal neurons degenerated among patients reached of disease of     Huntington by homologous neurons coming from human foetuses, by comparison of a treated group     and a reference group not-treaty. The principal criterion is the progression of the motor     score of the UHDRS by comparing the values obtained in the group treated by bilateral graft     intrastriatal of foetal neurons with the values obtained in the group controls. At the end of     this protocol, the patients controls will be grafted (with thus 18 months of time compared to     the treated group). A secondary evaluation is envisaged 18 months after the graft of the     group controls for the whole of the patients (either in 52 months). We will be able to thus     compare the pre performances and 18 months post-graft for all 60 patients.   "
179178|NCT00180375|"     This study evaluates the date of the first appropriate and/or inappropriate therapy in     patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual     predictive risk factors for appropriate/inappropriate therapies as well as the influence of     the programmed parameters on these therapies.   "
179094|NCT00190762|"     Based on results from earlier clinical trials, Pemetrexed may have antitumor activity as a     first-line agent in the treatment of mesothelioma. Given this, it is hypothesized that     Pemetrexed may be active in second-line mesothelioma in which the standard treatment is best     supportive care. This study will compare survival of previously treated patients with     malignant pleural mesothelioma who receive Pemetrexed plus best supportive care to the     survival of similar patients who receive best supportive care alone.   "
179071|NCT00190463|"     Empirical antifungal treatment is the gold standard for patients who are neutropenic and have     persistent fever under broad-spectrum antibiotics. The rational is that fungal infections are     difficult to early diagnose, and are life-threatening. Historical trials have shown a small     benefit of survival when this strategy is used. According to the drug usde for this strategy,     safety and costs may be concerns. However, since this routine practice has been implemented     in hematology, new non-invasive biological diagnostic methods are available to early diagnose     fungal infections, such as galactomannan antigenemia for aspergillosis. The goal of our study     is to show that limiting the administration of antifungals in this setting to patients with     clinical foci of infection, or to patients with a positive galactomannan antigenemia reduces     the risk of toxicity of the antifungal drug, and has no impact on the overall mortality of     patients treated with chemotherapy for hematologic malignancies.   "
179072|NCT00190476|"     To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone     for elderly patients with advanced non-small-cell lung cancer.   "
179073|NCT00190489|"     To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison     with standard AC for metastatic breast cancer   "
179074|NCT00190502|"     The primary objective of the study is:        -  To compare the effect of ATG treatment together with intensified insulin therapy (Group          1) on fasting and glucagon-stimulated C-peptide production with that of intensified          insulin therapy only (Group 2) in type 1 diabetes mellitus of recent onset      Secondary objectives are:        -  To compare the insulin doses between the two groups at 6, 12, 18, and 24 months after          diabetes onset        -  To compare the course of the specific humoral markers of autoimmunity between the groups        -  To evaluate the significance of in vitro testing of specific T-cell activation by an          autoantigen in the long-term follow-up in type 1 diabetes        -  To assess the safety of ATG treatment in type 1 diabetes   "
179075|NCT00190515|"     To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy     for stage III colorectal cancer.   "
179076|NCT00190528|"     To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II     cervical cancer   "
179077|NCT00190541|"     The purpose of this study is to evaluate the of international standard operation, mesorectal     excision (ME alone) compared to Japanese standard operation, ME with lateral lymph node     dissection for clinical stage II, III lower rectal cancer   "
179078|NCT00190554|"     To determine whether chemotherapy before surgery makes better outcome than chemotherapy after     surgery in patients with esophageal squamous cell carcinoma   "
179079|NCT00190567|"     Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared     with placebo in the treatment of women with pure genuine stress incontinence   "
179080|NCT00190580|"     The purpose of this study is to prove the hypothesis that the progression of renal and     cardiovascular disease is more efficiently prevented when the angiotensin II receptor blocker     valsartan is added to conventional antihypertensive therapy.   "
179081|NCT00190593|"     The purpose of this study is to determine whether raloxifene compared with placebo lowers the     risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal     women at risk for major coronary events.   "
179082|NCT00190606|"     The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle     training with that of placebo in patients with moderate to severe stress urinary incontinence   "
179083|NCT00190619|"     The purpose of this study is to monitor the long term safety and efficacy of duloxetine in     the treatment of severe pure genuine stress incontinence.   "
179084|NCT00190632|"     This is an on-going study to evaluate the long-term safety and maintenance of effect of     duloxetine in patients suffering with stress urinary incontinence.   "
179085|NCT00190645|"     The patients are being followed in this study to determine the safety of taking the     medication Duloxetine for a long period of time. The patients participating in this study     suffer from Stress Urinary Incontinence.   "
179086|NCT00190658|"     This clinical trial will compare the mean first year height velocity of somatropin-treated     prepubertal patients with SHOX deficiency with the height velocity of a control group of     untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a     somatropin-treated group of girls with Turner syndrome. After the second year patients in the     control group have the option to receive treatment as well. All patients will optionally be     treated until they achieved adult height.   "
179087|NCT00190671|"     This is the phase 2 portion of a phase 1/2 trial, testing the use of pemetrexed and     cyclophosphamide in combination for the treatment of advanced breast cancer. A single arm     Phase 1 dose finding (establish maximum tolerated dose) study precedes the randomized phase 2     portion.   "
179088|NCT00190684|"     To learn about the safety and any side effects of atomoxetine when given to children and     adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children     and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for     about 5 years (long-term).      Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been     interrupted or, atomoxetine experienced on a known stable dose.   "
179089|NCT00190697|"     Patients who were previously enrolled on the LY353381 arm of any LY353381 oncology trial     could enroll in this roll-over study if they had exhibited clinical benefit from treatment     and wished to continue on treatment. Patients were monitored for safety.   "
179090|NCT00190710|"     To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin     versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.   "
179091|NCT00190723|"     1. The safety of LY317615 and any side effects that might be associated with the drug.        2. Whether LY317615, can help patients with brain tumors.   "
179092|NCT00190736|"     A study to compare the effect of once-daily atomoxetine versus placebo in treating symptoms     of ADHD in adults for up to 6 months.   "
179093|NCT00190749|"     This study will assess whether olanzapine and/or risperidone affect the way the human body     uses sugar in the blood.   "
179179|NCT00180388|"     The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of     life and wound healing after endoscopic vein harvesting versus open vein harvesting.   "
179095|NCT00190775|"     This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment     trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are     currently living in a family situation with at least one child. The primary objective of the     study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of     ADHD symptoms over 12 and 24 weeks of blinded treatment.   "
179096|NCT00190788|"     The purpose of this study is to determine whether continued administration of Drotrecogin     Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion     period - results in a more rapid resolution of hypotension in severe septic patients.   "
179097|NCT00190801|"     Pemetrexed has shown an anti-tumor activity in advanced gastric cancer patients in a previous     study, while cisplatin is widely used in the combination chemotherapy of gastric cancer.     Pemetrexed has shown synergy with cisplatin in preclinical models and in various human     cancers. The introduction of vitamin supplementation has made treatment with pemetrexed plus     cisplatin safe and well tolerated. The present phase 2 study is an effort to determine the     efficacy and safety of the combination of pemetrexed and cisplatin in Korean patients with     gastric carcinoma who had no prior palliative chemotherapy for advanced disease. The     patients, who will give their consent for participating in this study, will be screened for     their eligibility and on meeting pre-defined study eligibility criteria, they will receive an     intravenous therapy of the combination of pemetrexed and cisplatin for number of times that     in the opinion of their treating physician is appropriate for them. A response rate of 30% is     considered as the minimum activity level of interest for this patient population.   "
179098|NCT00190814|"     The purpose of the study is to evaluate the effectiveness of duloxetine in reducing urinary     incontinence(leakage of urine)occurrences in women due to physical stress and leakage that     occurs during a strong need(urge) to urinate.   "
179099|NCT00190827|"     The study evaluates the effectiveness of duloxetine in reducing urinary incontinence     occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence     is the inability to control bladder function with leakage of urine.   "
179100|NCT00190840|"     In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small     cell lung cancer as a single agent as well as in combination with cisplatin. Since the     introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety.     Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed     dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with     supplementation may increase pemetrexed's efficacy without unduly compromising safety. The     present Phase 2 study will use pemetrexed dosing that is tailored to individual patient     tolerance, and is an effort to determine the efficacy and safety of this approach in patients     with advanced NSCLC who had prior chemotherapy.   "
179101|NCT00190853|"     Biomechanical and electrophysiological effects of duloxetine in the treatment of women with     urinary stress incontinence   "
179102|NCT00190866|"     To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in     patients with Fibromyalgia syndrome, with or without major depressive disorder.   "
179103|NCT00190879|"     To investigate the effect of atomoxetine hydrochloride in treating adults who have attention     deficit hyperactivity disorder with comorbid social anxiety disorder   "
179104|NCT00190892|"     This trial will assess any efficacious benefit and any safety issues associated with the     concomitant use of olanzapine and carbamazepine for the treatment of patients with bipolar I     disorder, manic or mixed episodes   "
179105|NCT00190905|"     The purpose of the trial is to study the safety and effectiveness of duloxetine HCl in women     of different backgrounds with stress urinary incontinence who may also have other various     medical conditions.   "
179106|NCT00190918|"     This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low     risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.   "
179107|NCT00190931|"     The overall primary objective of this study is to test the hypothesis that, compared with     placebo,administration of atomoxetine will result in an improved work productivity.   "
179108|NCT00190944|"     Effects of Teriparatide on Distal Radius Fracture Healing   "
179109|NCT00190957|"     Atomoxetine Treatment of Adults with ADHD and Comorbid Alcohol Abuse   "
179110|NCT00190970|"     To determine the effect of Ruboxistaurin on small fiber function.   "
179111|NCT00190983|"     This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV     over 10 minutes in patients with recurrent cervical cancer.   "
179112|NCT00190996|"     The purposes of this study are to determine whether duloxetine can help subjects with stress     urinary incontinence and to see whether the effects of duloxetine can be maintained.   "
179113|NCT00191009|"     This study will compare atomoxetine to placebo when taken with current standard Alzheimer's     Disease medications. The treatment will take approximately 6 months and it is hypothesized     atomoxetine will significantly improve cognitive performance as compared to placebo.   "
179114|NCT00191022|"     This study is a Phase 2 trial to test the efficacy of LY686017 in the treatment of Social     Anxiety Disorder.   "
179115|NCT00191035|"     The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine     administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52     weeks   "
179116|NCT00191048|"     The purpose of this study is to assess the efficacy and safety of atomoxetine administered     once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.   "
179117|NCT00191061|"     The purpose of this study is to compare the tolerability and efficacy of different doses of     duloxetine in patients with major depressive disorder.   "
179118|NCT00191074|"     After approval of amendment (g), patients who were still receiving study drug at the time     were scheduled for a study visit. In addition, patients who had discontinued early from the     core, blinded phase of the study were contacted.      All of these patients were offered the opportunity to enter the unblinded extension phase (if     they met eligibility criteria) and continue somatropin treatment (regardless of initial     treatment randomization) until they reached final height.   "
179119|NCT00191087|"     The purpose of this study is to monitor the long term safety of duloxetine in the treatment     of stress urinary incontinence.   "
179120|NCT00191100|"     The purpose of this study is to compare the effectiveness of two methods of treating cancer     of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing     radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will     receive cisplatin along with radiation therapy without adjuvant therapy.   "
179121|NCT00191113|"     A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger     than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin)     treatment in promoting linear growth to final height.   "
179122|NCT00191126|"     Preoperative chemotherapy is considered to play a role in early stage non small cell lung     cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven     feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the     present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with     Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery     alone. Postoperative chemotherapy will not be utilized in this Phase III trial.   "
179123|NCT00191139|"     To assess the 2 year survival of patients with Stage III unresectable non-small cell lung     cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent     chemotherapy and radiation.   "
179124|NCT00191152|"     This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/     capecitabine doublets, with crossover to the alternate agent. The experimental arm will     receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75     mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive     docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1     through 14 repeated every three weeks. Patients who progress on the experimental arm, will be     treated with capecitabine as dosed on the comparator arm. Patients who progress on the     comparator arm will be treated with gemcitabine as dosed on the experimental arm.   "
179125|NCT00191165|"     Multi-center, randomized, controlled, open-label, phase III study comparing the effects of     two different dosages of somatropin treatment (in-label or doubled) after 12 and 24 months of     treatment, on height velocity in early pubertal children with growth hormone deficiency     (GHD). The study will be conducted in Italy. Approximately 26 subjects will participate in     this study, distributed as 13 in the in-label dosage group (group A) and 13 in the doubled     dosage group (group B).   "
179126|NCT00191178|"     This study investigates the influence of two different insulin regimens, twice-daily insulin     lispro low mix (LM) and once-daily insulin glargine, on perceived physical, mood, and     cognitive symptoms as well as cognitive-motor task performance in patients with type 2     diabetes.   "
179127|NCT00191191|"     To investigate efficacy and safety of pemetrexed as second or third line therapy in patients     with non-small cell lung cancer (NSCLC).   "
179128|NCT00191204|"     The purpose of this study is to monitor the long term safety of duloxetine in the treatment     of stress urinary incontinence.   "
179129|NCT00191230|"     To study the efficacy and tolerability of gemcitabine/platinum chemotherapy in non small cell     lung cancer   "
179130|NCT00191243|"     Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients     will be treated with docetaxel or docetaxel-gemcitabine.      Aim of the study is to assess the optimal dosage and safety in this setting.   "
179131|NCT00191256|"     To evaluate the rate of complete pathological response after 3 cycles of gemcitabine     containing chemotherapy.   "
179132|NCT00191269|"     To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with     anthracycline and taxane regimen for patients with metastatic breast cancer   "
179133|NCT00191282|"     The primary objective was to demonstrate a difference between two insulin strategies, one     targeting postprandial (PP) hyperglycemia and the other targeting fasting and interprandial     hyperglycemia, on time until the first combined adjudicated cardiovascular (CV) event     (primary outcome defined as CV death, nonfatal myocardial infarction [MI], nonfatal stroke,     coronary revascularization, or hospitalized acute coronary syndrome).   "
179134|NCT00191295|"     Atomoxetine versus placebo in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)   "
179135|NCT00191308|"     The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant     chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC)     is to look at various genes present in participants' blood and tumor tissue to see if there     is any link between the levels or changes in the genes and how participants with lung cancer     respond to pemetrexed and cisplatin treatment.   "
179136|NCT00179829|"     The purpose of this study is to determine if WT1 is an adequate measurement of minimal     residual disease in leukemic patients.   "
179137|NCT00179842|"     The investigators anticipate that this study will also form the basis to clarify further the     role of the immune system in Crohn's disease.   "
179138|NCT00179855|"     The purpose of this research study is to evaluate the safety and feasibility of     extracorporeal photopheresis (ECP) in the treatment of steroid-refractory acute     graft-versus-host disease (GVHD) in children.   "
179139|NCT00179868|"     The purpose of this study is to determine if C-Reactive Protein levels are predictive for     complications post transplant.   "
179150|NCT00180011|"     This study will be a randomized, placebo controlled, double blind study to measure the safety     and efficacy of a new, injectable asthma medication, omalizumab, in a group of minority with     moderate to severe asthma who are not adequately controlled with use of inhaled or oral     steroids. Primary endpont will be change in asthma symptom utility index. Secondary endpoints     will be changes in asthma Quality of life, asthma exacerbation rate, and lung function over     the 12 week treatment period.   "
179152|NCT00180037|"     This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed     solution in middle-stage Parkinson's disease (PD) patients (Hoehn&Yahr II to III). The     treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo.      The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS)     Part II and III.      The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased     dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of     parkinsonian symptoms in PD patients.   "
179140|NCT00179881|"     Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin.     Thalidomide has been available for many years and has been used to treat many different     illnesses. Carboplatin is an effective medicine in killing cancer cells. Thalidomide works by     blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have     blood vessels providing oxygen and nutrients, it will not be able to grow. This research will     look at how combining the effects of thalidomide (preventing tumor growth) with the tumor     killing effect of carboplatin effects the long-term outlook for patients with these tumors.      This study will try to find out how well Thalomid™ and carboplatin combined with radiation     therapy works in treating children newly diagnosed with brain stem glioma. This study will     look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem     glioma. This study will also look at any side effects of these treatments.   "
179141|NCT00179894|"     This study will determine the effectiveness of educating pediatricians about attention     deficit hyperactivity disorder treatment guidelines in improving child behavior and     pediatricians' adherence to medication guidelines.   "
179142|NCT00179907|"     The standard treatment for children with brain tumors is surgical removal of the tumor     followed by radiation to the brain and chemotherapy (medicines) given to shrink any remaining     tumor or to prevent tumor from growing back. There are very few treatment options available     for children whose brain tumor grows back after receiving radiation treatment. There is a     greater risk of complications and side effects when the brain is repeatedly treated with     external radiation. The side effects of repeat radiation treatment are dependent on the     amount of the brain that is radiated. Radiation given with PRS during surgery is focused to     the specific area of the brain where the tumor is located. Therefore, the area of the brain     affected by the radiation is smaller. It is hoped that this targeted radiation will lessen     the side effects to the normal brain that is not affected by the tumor. It is also hoped that     a lower occurrence of side effects will increase the quality of life of children with brain     tumors.      The optimal dose of targeted radiation is not known. Therefore, increasing doses will be     given to treat different patients, starting with the lowest possible dose. The amount of     radiation to be given will depend on whether or not your child received prior radiation     therapy and where the tumor is located. The groups of patients will first be divided into 2     groups: Group A, who are those who received radiation as part of their prior treatment, and     Group B, who are those who did not receive any radiation treatment. Each group will be then     divided again into 2 groups depending on the location of the tumor. In each group, if the     lowest dose is well-tolerated with only minimal side effects by 3 patients, then the next     higher dose will be given to the next 3 patients.      The purposes of this research are:        -  To evaluate the potential side effects of a single high dose of x-rays using the Photon          Radiosurgery System (PRS) given to a small area of the brain.        -  To determine the maximum dose of targeted radiation that can be safely given to brain          tumors with the fewest side effects.        -  To see how well this treatment works for children with recurrent brain tumors and          newly-diagnosed glioblastoma multiforme.   "
179143|NCT00179920|"     Retinoblastoma is an unusual cancer of early childhood involving tumor is both eyes or, in     certain circumstances, one eye only. This condition is the result of an abnormal gene which     makes both retinas (the back of the eye) vulnerable to develop multiple tumors. Growths in     the eye impair vision temporarily or permanently. These tumors are malignant, which means     that they can grow within the eye, spread outside of the eye, and be fatal if untreated.      Standard therapy for bilateral retinoblastoma includes removal of one eye if vision cannot be     save and radiation treatment of either eye in which vision might be saved. Radiation controls     tumor growth in the majority of cases. Another standard method is cryotherapy (freezing a     tumor to kill it). Chemotherapy (medicines used to kill tumor cells) has been used in the     past for tumor in or outside the eye, but is not standard. Hyperthermia, increasing the     temperature of a tumor to kill it, is widely performed, and can be done to a retinoblastoma     tumor by a laser; this method is not standard.      The problem with removal of an eye is that any hope of vision is lost. The problems with     radiation include incomplete control of tumor, injury to the eye or surrounding tissue with     decreased growth, and that (due to the abnormal retinoblastoma gene) children are very     susceptible to develop other tumors, especially in the tissue which was given radiation.      The doctors at Children's Memorial Hospital are using a newer form of treatment, including     laser hyperthermia, chemotherapy and cryotherapy to decrease retinoblastoma tumors. Some may     be controlled indefinitely, reducing the number of eyes that need radiation or removal.      OBJECTIVES        1. To find out how well chemotherapy plus cryotherapy and laser hyperthermia work on          retinoblastoma tumors.        2. To find out whether vision can be saved and tumors controlled without radiation or          removal of the eye.   "
179144|NCT00179933|"     The purpose of this study is to evaluate the impact of the NIDCAP program of individualized     patient consultation on the neurobehavioral organization of transported preterm infants in     the NICU. Behavioral response to routine caregiving will be compared between infants in the     pre-NIDCAP group to infants in the post-NIDCAP group. And it is this behavioral response that     will be used to evaluate the effectiveness of the NIDCAP program.   "
179145|NCT00179946|"     The aim of this protocol is to clarify the role of HLA matching in unrelated umbilical cord     blood (UCB) transplantation and to identify the level of HLA matching required assuring     successful outcome of unrelated UCB transplantation.   "
179146|NCT00179959|"     Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary     complication of atopic dermatitis (AD), but also as a culprit in the worsening of this     condition. In addition, the recent development of community acquired methicillin-resistant S.     aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of     acute infections and maintenance therapy. The investigators would like to perform a     randomized investigator-blinded placebo-controlled study of children aged 6 months to 17     years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial     infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the     relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to     clinical response to oral cephalexin therapy and severity of the AD; and 3) whether     concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and     sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical     stability.   "
179147|NCT00179972|"     The purpose of this study is to evaluate sensor longevity and skin integrity with two     different models of neonatal pulse oximetry sensors currently used for monitoring oxygen     levels in small infants.   "
179148|NCT00179985|"     The purpose of this study is to determine whether implementing the Newborn Individualized     Developmental Care and Assessment Program increases NICU nurses' sensitivity in meeting the     developmental care needs of preterm infants.   "
179149|NCT00179998|"     This is a study to find out whether Pulmozyme is effective for clearing mucus from the     airways of children with cystic fibrosis less than 3 ½ years of age. Pulmozyme is given using     a nebulizer and is now widely used in older children and adults with cystic fibrosis. In     adults and older children, studies have shown that daily use of Pulmozyme improves lung     function and decreases the number of lung infections requiring hospital treatment. Pulmozyme     has been approved by the Food and Drug Administration for use in children over 5 years old     and adults with cystic fibrosis. Pulmozyme has also been approved by the FDA for use in     children with cystic fibrosis less than 5 years old based upon studies showing that it is     safe in this age group and that it does get into the airway tubes as well in infants and     toddlers as it does in older children and adults. Currently Pulmozyme is not widely used in     children with cystic fibrosis younger than 5 years because no study has clearly shown that     inhaling Pulmozyme daily improves lung function or improves clearance of mucus from the     airway tubes in very young children. This study will measure whether Pulmozyme improves lung     function and mucous clearance from the lungs in children with cystic fibrosis less than 3 ½     years of age.      This study will compare Pulmozyme to a placebo. During the study infants and young children     with cystic fibrosis will be treated with Pulmozyme for 6 months and placebo for 6 months.     The study medicines will be inhaled at home once a day from a nebulizer for a period of one     year. Half of the children will be treated with Pulmozyme for the first 6 months of the study     and half will receive the placebo. At the 6 month point the group receiving Pulmozyme will be     changed to the placebo and the group receiving placebo will be changed to Pulmozyme. The     order of the 6 month treatment periods is randomized. This study is blinded. The study doctor     and his staff will not know who is receiving Pulmozyme or placebo at any time during the     study.      Whether Pulmozyme works will be measured using infant lung function tests and by doing a     special 3-D x-ray of the child's chest (a high resolution CT or HRCT) at the beginning of the     study, at 6 months and at 12 month after starting study. The study will not change the     regular clinical care.   "
179156|NCT00180089|"     The purpose of this study is to determine whether orale budesonide is effective in the     prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic     stem cell transplantation.   "
179157|NCT00180102|"     AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem     cell transplantation in aplasia after induction therapy for high risk patients with acute     myeloid leukemia.   "
179158|NCT00180115|"     The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy     including related and unrelated allogeneic stem cell transplantation for high risk AML     patients and related allogeneic and autologous stem cell transplantation for standard risk     AML patients in a multi-center setting. Furthermore it randomizes patients between     intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.   "
179159|NCT00180128|"     In AIDA 2000 therapy of acute promyelocytic leukemia (APL) is given in a risk-adapted manner.     Risk factors are age and white-blood-cell (WBC)-count at diagnosis. Induction therapy is done     with ATRA and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone     in age adapted dosages. Patients with an high WBC were additionally treated with cytarabine.     Finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and ATRA     is performed.   "
179160|NCT00180141|"     Atopic dermatitis is a common disease. Emollients and Elidel have both shown to be effective     to treat this disease. The research question is, whether the effective component (Elidel) is     better than the emollient to improve the skin function.   "
179161|NCT00180154|"     The purpose of the study is to describe the regional and global FDG-kinetics in     non-small-cell lung cancer (NSCLC) during percutaneous radiation therapy.   "
179162|NCT00180167|"     Single Arm-Studies suggest improved remission and survival rates for a Protocol with     Mitoxantron 10mg/m2 for 3 days combined with AraC 1g/m2 bid on days 1+3+5+7 compared to a     conventional DA 7+3 protocol (45mg/m2 Daunorubicin).   "
179163|NCT00180180|"     The purpose of this study is to describe the regional and global tumor hypoxia in     head-and-neck cancer during percutaneous radiation therapy   "
179164|NCT00180193|"     The purpose of this study is to monitor the amino acid uptake of brain tumors, before and     during radiotherapy, with positron emission tomography.   "
179165|NCT00180206|"     The purpose of this study is the investigation of the functional and radiological results and     subjective patient outcome after the implantation of a hip resurfacing endoprosthesis     (Birmingham hip resurfacing).   "
179166|NCT00180219|"     This is a single-centre, open, parallel-group study with three age groups; no study     medication or intervention will be provided. This is a longitudinal follow-up of     physiological parameters.   "
179167|NCT00180232|"     The study tries to reveal if aminobisphosphonates influence aside the bone density also the     vascular status in the typical elderly patient population   "
179168|NCT00180245|"     The purpose of the study is to describe the regional and global FDG-kinetics in head and neck     cancer during percutaneous radiation therapy.   "
179169|NCT00180258|"     The purpose of this study is to determine whether combined mortality and hospitalization in     heart failure patients receiving optimal pharmacologic therapy can be reduced by combining     optimal pharmacologic therapy and 1) biventricular pacing therapy alone or 2) biventricular     pacing with defibrillation.   "
179170|NCT00180271|"     The MADIT-CRT trial is designed to determine if combined implantable cardiac defibrillator     (ICD)-cardiac resynchronization therapy (CRT-D) will reduce the risk of mortality and heart     failure (HF) events by approximately 25%, in subjects who are in New York Heart Association     (NYHA) functional Class II with non-ischemic or ischemic cardiomyopathy and subjects who are     in NYHA functional Class I with ischemic cardiomyopathy, left ventricular dysfunction     (ejection fraction [EF] < or = 0.30), and prolonged intraventricular conduction (QRS duration     > or = 130 ms).   "
179171|NCT00180284|"     The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical     performance of the SITELINE 2 Polyurethane pacing lead.   "
179172|NCT00180297|"     The purpose of this study is to determine the safety and efficacy of the implant of a ICD     lead of defibrillation in the septum of the right ventricle   "
179173|NCT00180310|"     Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical     trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved     commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent     System.      TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston     Scientific.   "
179174|NCT00180323|"     This prospective study will evaluate in patients, fulfilling implant criteria for Cardiac     Resynchronisation Therapy (CRT) implant, the optimal atrial contribution to the     resynchronised ventricles in the event of right atrial pacing.   "
179175|NCT00180336|"     The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4     AVT device.   "
179176|NCT00180349|"     The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™     defibrillation leads connected to a defibrillator or a cardiac resynchronization     defibrillator from implant until 12 months.   "
187719|NCT00304876|"     The investigators propose to study intensively the bacteriology of feces in C. difficile     associated diarrheal disease, using a variety of conventional and very up-to-date techniques.   "
179181|NCT00180414|"     This study will look at the correlation between ventricular rate regulation (VRR) and the     percentage of biventricular pacing as well as subjective quality of life and level of     physical ability in CRT patients with atrial fibrillation.   "
179182|NCT00180427|"     The purpose of this study is to evaluate the influence of the rate response function of     implantable cardioverter defibrillators (ICDs) on the frequency of ventricular arrhythmias in     patients with an ICD.   "
179183|NCT00180440|"     The INSURE trial is a multi-center, prospective trial to collect information about adequate     ICD therapies in ICD patients before and after their first elective ICD replacement.   "
179184|NCT00180453|"     Prospective, randomized, controlled, single-blinded, parallel two-arm, multicenter trial.      Test arm: XIENCE V® Everolimus Eluting Coronary Stent System(stent length: 18mm, diameter:     3.0mm) Control arm: Metallic stent (MULTI-LINK VISION® metallic stent(stent length: 18mm,     diameter: 3.0mm) Follow-up angiographic imaging and intra vascular ultra sound (IVUS) at 180     days and 1 year   "
179185|NCT00180466|"     PROSPECT is a multi-center prospective registry of Acute Coronary Syndromes (ACS) patients     with single or double vessel coronary artery disease. Approximately 700 patients with ACS     will be enrolled into the study at sites in the United States and European Union.   "
179186|NCT00180479|"     This study is divided into 5 arms:        1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single          blind, parallel two-arm multi-center clinical trial in the United States (US) comparing          XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter          stents) to the Food and Drug Administration (FDA) approved commercially available active          control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS)          System        2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS        3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS        4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS        5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0          mm diameter stents) in Japan      The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston     Scientific.   "
179187|NCT00180492|"     This purpose of this study is to collect data on the FDA-approved ACCULINK(TM) Carotid Stent     System and FDA 510(k)-cleared ACCUNET(TM) Embolic Protection System for the treatment of     patients with atherosclerotic disease, when used by physicians under commercial use     conditions.   "
179188|NCT00180505|"     The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral     self-expanding stent system in preventing restenosis of occluded or stenotic superficial     femoral or proximal popliteal arteries.   "
179189|NCT00180518|"     1. To evaluate the safety and efficacy of the over-the-wire (OTW) ACCULINK (tm) System in          patients deemed to be either at high risk or unsuitable for carotid endarterectomy (CEA)        2. To evaluate the efficacy of the OTW ACCUNET System in patients deemed to be either at          high risk or unsuitable for carotid endarterectomy (CEA).        3. To demonstrate equivalence in the safety and performance of the RX ACCULINK Carotid          Stent System and RX ACCUNET Embolic Protection System and the corresponding OTW devices.   "
179190|NCT00180531|"     The objective of this study is to evaluate the prevalence of sustained ventricular and     supraventricular rhythm disorders in patients implanted with a CONTAK RENEWAL TR2 ventricular     resynchronization therapy (CRT) device   "
179191|NCT00180544|"     The purpose of this study is to evaluate the safety and effectiveness of the RX HERCULINK 14     Peripheral Stent System in treating atherosclerotic renal artery stenosis.   "
179192|NCT00180557|"     In this study the difference between screw in leads actively fixed in the septum and tined     leads passively fixed in the apex concerning electrical parameters and implantation time will     be evaluated. In addition the influence of the stimulation location by type of lead on QRS     width, ejection fraction and NYHA class will be evaluated using and electrocardiogram and     echocardiogram.   "
179193|NCT00180570|"     Randomised Comparison with regards to complication rate and electrical measurements of atrial     leads with different fixation mechnism   "
179194|NCT00180583|"     To assess the safety and effectiveness of intravascular brachytherapy for the treatment of     intrastent restenosis of coronary lesions with the Galileo system   "
179195|NCT00180596|"     The purpose of this study was to evaluate the benefit of biventricular pacing in patients     with heart failure who were receiving optimal pharmacological therapy, and who were either     with or without an ICD indication   "
179196|NCT00180609|"     The primary objective of this study is to document the success rate of the automatic     threshold testat pre-discharge in a normal pacemaker patient population implanted with     Guidant Insignia Ultra or AVT .   "
179197|NCT00180622|"     The primary aim of this study is to exploit a difference between COPD patients, chronic     smokers without COPD and healthy non-smoking subjects. This will help to assess the utility     of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the     lung function, clinical parameters and computerised tomography (CT).   "
179198|NCT00180635|"     The primary aim of this study is to investigate the effects of oral and inhaled     administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled     NO and NO metabolites in exhaled breath condensate, induced sputum, nasal lavage and mouth     wash fluid in healthy non-smokers, current smokers and patients with COPD.   "
179199|NCT00180648|"     The purpose of this study is to investigate the theory that the plasma level of Glucagon like     peptide 2 (GLP-2) in patients with intestinal failure can predict their clinical recovery.   "
179200|NCT00191321|"     A pilot study on the use of Teriparatide in severe osteoporotic women with hip fracture and     submitted to hip replacement      The primary objective of this study is to obtain preliminary data, in a pilot group of     postmenopausal women with established osteoporosis and a recent hip fracture, who underwent     hip replacement 3-6 months before screening phase, about the effect of teriparatide on:        -  bone turnover markers: CTx, PINP and BSAP when given at the dose of 20 mcg/day by          subcutaneous route for 18 months.      The secondary objectives of the study are as follows:        -  Effects of teriparatide on lumbar spine and non-prosthetic femur bone density, as          assessed by BMD measurement with dual energy x-ray absorptiometry (DXA)        -  Effects of teriparatide on quality of life and back pain during treatment.   "
179201|NCT00191334|"     The primary endpoint of this study is to assess the objective tumor response rate in patients     with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250     mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment   "
179202|NCT00191347|"     This study is designed to determine the efficacy of the biweekly pemetrexed/gemcitabine     regimen when given to patients with metastatic breast cancer. Each agent has well     demonstrated antitumor activity in patients with locally advanced or metastatic breast     cancer. In addition, in the phase I combination trial of the two agents, a durable tumor     response was seen in one out of three heavily pretreated breast cancer patients (Adjei et al.     2000). Therefore, it is reasonable to expect that the combination of pemetrexed and     gemcitabine administered may be associated with considerably more anti-tumor activity than     either agent alone. If such activity is seen in this study, randomized studies comparing this     combination with other active agents or combinations of active agents will be considered.   "
179204|NCT00191373|"     This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over     approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be     administered over 90 minutes on day 1 of the first cycle, then 6mg/kg as a 30 minute infusion     administered on subsequent cycles.   "
179205|NCT00191386|"     The study is long-term extension study to evaluate long-term safety and efficacy of     Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder     (AD/HD).   "
179206|NCT00191399|"     The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine     combined on all the visits as compared with the baseline visit in patients with bipolar     disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale     (MADRS).   "
179207|NCT00191412|"     This study is to assess the response rate, toxicity, time-to-event efficacy, and potential     markers of pemetrexed in patients with liver cancer.   "
179208|NCT00191425|"     The primary purpose of the study is to compare 3 different osteoporosis therapies following     one year of teriparatide.In the first year,all eligible patients received open-label     teriparatide 20 micrograms/day.After 1 year, patients are randomly assigned to one of 3     possible follow-up treatment regimens for the second 12 months: continuation of teriparatide,     switch to raloxifene, or no pharmacological treatment(other than the calcium and vitamin D     supplements that everyone receives). Patients are stratified into 3 subsets: (a) patients who     have never received any anti-osteoporosis treatment before; (b) patients who received prior     antiresorptive treatment successfully; (c) patients who failed to respond adequately to prior     antiresorptive drugs (such as bisphosphonates or raloxifene) in the past. These latter     patients are not randomized at month 12 but will continue treatment with teriparatide 20     micrograms/day throughout the second year.   "
179209|NCT00191438|"     This is a phase III randomized study which compares two different regimens of chemotherapy.     The purpose of the study is to determine which of the two regimens will make the tumor     smaller or disappear, and for how long. In addition the disease-related symptoms will be     evaluated. The safety of the drugs will be determined based upon evaluation of the side     effects   "
179210|NCT00191451|"     The purposes of this study are to determine the safety of gemcitabine and paraplatin either     with or without trastuzumab Any side effects that might be associated with these compounds.     Whether the two or three drugs listed above when given in combination can help patients with     metastatic breast cancer. How long the treatment will stop the growth of the cancer.   "
179211|NCT00191464|"     The primary objective of this study is to show that a prandial insulin regimen, consisting of     premeal insulin lispro mid mixture (or a combined regimen of insulin lispro mid mixture     and insulin lispro low mixture) plus metformin will result in significantly better overall     glycemic control (lower HbA1c) at endpoint than once-daily insulin glargine plus metformin.     Insulin lispro mid mixture consists of 50% insulin lispro and 50% NPL. Insulin lispro low     mixture consists of 25% insulin lispro and 75% NPL.      In a substudy of approximately 60 patients, additional data will be collected on markers     associated with risk of atherosclerosis or cardiovascular disease in the context of a     controlled, outpatient, high-fat test meal.   "
179212|NCT00191477|"     A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the     efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately     after transurethral resection of the bladder tumor.   "
179213|NCT00191490|"     Phase II study that will evaluate the activity of gemcitabine as intravesical therapy on the     marker lesion in superficial bladder carcinoma at intermediate risk. Primary objective is the     evaluation of the pathological complete response after 8 instillation of gemcitabine. 46     patients are requested.   "
179214|NCT00191503|"     There is no standard treatment for the patient population being asked to participate in this     study. Although one current regimen, used by some investigators, has a high rate of response     compared to other therapies, it is associated with moderate to severe toxicity. As     gemcitabine and pemetrexed have a broad range of activity against cancer it is reasonable to     determine how active and safe they are against patients with this type of cancer.The     objective of this study is to determine the anti-tumor activity of pemetrexed and gemcitabine     in patients with this condition.   "
179215|NCT00191516|"     A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and     tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by     patients, parents and physicians, and its impact on quality of sleep in children (aged 6     through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in     Germany. An 8-week treatment phase is followed by a 16-week extension period.   "
179216|NCT00191529|"     Comparison of 2 different doses of human growth hormone treatment on change in height after 1     and 2 years of treatment.   "
179217|NCT00191542|"     Comparison of the effect of Atomoxetine and psychoeducation with placebo and psychoeducation     after 10 weeks of treatment   "
179218|NCT00191555|"     The objective of this study is to demonstrate that there is a benefit in switching chronic     schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy,     neurological safety and patient's outcome.   "
179219|NCT00191568|"     A non-randomized phase II study to determine the efficacy and safety of the combination of     Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with     surgically resected pancreatic cancer.   "
179220|NCT00191581|"     The primary objective of this study is to compare the 2-hour PPBG excursion following a     standard test meal in insulin-requiring diabetic patients treated twice daily with human     insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with     insulin lispro mix 50/50.   "
179221|NCT00191594|"     A study in patients with depression   "
179222|NCT00191607|"     This trial compares two chemotherapy agents for the treatment of recurrent ovarian, fallopian     or primary peritoneal cancer in patients that have received and are no longer responding to     Platinum based treatment. The purpose of this trial is to compare progression free survival     between gemcitabine and liposomal doxorubicin. Progression free survival (PFS) is defined as     the period from study entry until disease progression   "
179236|NCT00194324|"     This study uses MRI to detect the spread of the Miconozole Nitrate OVULE within the vagina.     The effect of moderate amounts of physical activity on the spread will be evaluated, and     compared to no physical activity.   "
179223|NCT00191620|"     The purposes of this study are to determine:      How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus     cisplatin in the treatment of non-small cell lung cancer.      The safety of standard gemcitabine plus cisplatin and any side effects that might be     associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.   "
179224|NCT00191633|"     The purpose of this study is to assess whether changes in the symptoms of ADHD show a     relationship with changes in functioning in children with ADHD treated with atomoxetine over     a 3-month period.   "
179225|NCT00191646|"     This is a phase III randomized study comparing induction treatments of Gemcitabine and     Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for     patients that do not have any evidence of disease after completion of six cycles of induction     therapy. Patients with disease after induction therapy will crossover to receive single agent     therapy.   "
179226|NCT00194194|"     This study is designed to gain experience with the HealtheTech measurement system     (BalanceLog) in the context of a clinical trial and to develop the related treatment     protocols. In this study the aim is to evaluate two interventions, one moderate and the other     intensive behavioral management. The development and evaluation of a HealtheTech protocol     across these two treatment settings will provide useful data about implementation (e.g.,     technical issues, clinical issues, participant satisfaction) and outcomes (weight loss,     retention). These data can provide empirical and clinical support for practice guidelines.   "
179227|NCT00194207|"     The purpose of this study is to identify elements of a patient's demographics, history, and     clinical presentation that may aid in differentiating between patients with an ectopic     pregnancy, miscarriage, or normal intrauterine pregnancy. This study will also evaluate     serial levels of human chorionic gonadotropin in the serum of these patients, as another way     to make the diagnosis.   "
179228|NCT00194220|"     This study is only collecting specimens from current patients of PENN Fertility Care.      The purpose of this investigation is to assess if markers of oxidative stress that are known     to be associated with other medical conditions can be detected in women undergoing     infertility treatment and normal women of similar age. Oxidative stress may affect a woman's     eggs or the follicular cells that surround and nurture them. Other markers of to be     investigated include markers of cellular aging and DNA structural changes.      Presence of these markers will be compared in blood and urine samples taken during     infertility treatment, and follicular fluid at the time of IVF (if applicable).   "
179229|NCT00194233|"     The purpose of this study is to investigate differences in protein expression profiles of     blood and peritoneal fluid samples obtained from patients who do, and those who do not, have     endometriosis seen during laparoscopic surgery. These profiles may include both known and     novel markers for diagnosing endometriosis.   "
179230|NCT00194246|"     We are interested in testing differences in cognitive function and food reactivity at various     time points in individuals following low and high carbohydrate diets. We wish to achieve an     understanding of these time-specific differences using repeated measures analysis of variance     (ANOVA), with diet condition (low vs. high carbohydrate) as a between subject factor and time     as a within-subject factor.   "
179231|NCT00194259|"     This study will assess the effects of weight loss on sleep-disordered breathing (SDB) in 120     obese, type 2 diabetics with obstructive sleep apnea (OSA) from four Look AHEAD sites.     Changes in SDB will be compared between subjects randomized to weight loss (Lifestyle     Intervention Group) versus non-weight loss (Diabetes Education and Support Group) conditions     within the context of the Look AHEAD Study. Weight loss is frequently recommended for obese     patients with OSA, but the empirical foundation for this recommendation is not well     substantiated. Weight loss in obese apneics improves but does not eliminate SDB. Moreover,     the degree of improvement is not correlated with the amount of weight loss. This study will     assess SDB before treatment and at 1 and 2 years. We will also investigate clinical measures     of fat distribution that may mediate the non-linear relationship between weight loss and     improvements in SDB. Finally, we will examine the role of SDB in mediating changes in blood     pressure associated with weight loss.   "
179232|NCT00194272|"     This study examines the safety and acceptability of a novel two dose regimen of     methotrexate to treat ectopic pregnancy.   "
179233|NCT00194285|"     The main objective of the proposed research study is to determine the efficacy of [18-F]     Fluorodeoxyglucose (FDG) positron emission tomography (PET) in differentiating infections     from other complications such as loosening in patients with painful joint prosthesis. We     intend to validate and establish the necessary criteria for making such a diagnosis and     determine the accuracy of the technique through comparison with other existing modalities     such as white blood imaging and patient outcome. We expect that at the completion of the     proposed research, the role of this novel and powerful imaging modality will be clearly     defined in the management of patients with this challenging and serious complication.   "
179278|NCT00194896|"     The purpose of this research was to test whether one treatment was superior over another in     the management of type 1.5 diabetes. Specifically we tested recently diagnosed antibody     positive type 2 diabetic patients to determine whether treatment with rosiglitazone results     in greater preservation of beta cell function compared to treatment with glyburide.   "
188140|NCT00307437|"     The primary objective of this study is to evaluate the efficacy and safety of ustekinumab     (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.   "
179234|NCT00194298|"     The main objective of the proposed research study is to determine the potential utilization     of [18-F] Fluorodeoxyglucose (FDG) positron emission tomography (PET) in patients with     complicated diabetic foot, especially in the diagnosis or exclusion of osteomyelitis in this     setting. We intend to validate and establish the necessary criteria for making such a     diagnosis and determine the accuracy of the technique through comparison with other existing     modalities, including MRI, and patient outcome. We expect that at the completion of the     proposed research, the role of these powerful imaging modalities will be clearly defined in     the management of patients with this challenging and serious complication.   "
179235|NCT00194311|"     The purpose of this study is to determine if maternal infection with human papillomavirus     (HPV) is associated with pregnancy complications including spontaneous preterm delivery     (sPTD), severe preeclampsia (PE), and poor fetal growth.   "
179237|NCT00194337|"     RATIONALE: Diagnostic procedures, such as digital mammography, ultrasound, MRI, and PET     scans, may help find breast cancer and find out how far the disease has spread.      PURPOSE: This phase II/III trial is studying digital mammography, ultrasound, MRI, and PET     scans to compare how well they find the extent and spread of breast cancer in women with     newly diagnosed breast cancer.   "
179238|NCT00194350|"     The purpose of this study is to determine whether inherited thrombophilias (tendency toward     blood clotting) increase the risk of failure of the embryo to implant in IVF. The specific     condition to be studied is the presence or absence of the Leiden mutation of the Factor V     gene.   "
179239|NCT00194363|"     The purpose of the PAL trial is to increase the understanding of the experiences of long-term     breast cancer survivors.      Study hypothesis: Strength training will not increase the rate of lymphedema or worsen     lymphedema as compared to the non-exercising control participants.   "
179240|NCT00194376|"     Patients with a clinically indicated sleep study will be enrolled in this study. They will     have a diagnostic and a therapeutic sleep study with continuous positive airway pressure     ventilation. For both studies a pH probe will be placed nasal to measure the amount of acidic     reflux during each study. Baseline levels of reflux from the diagnostic sleep study will be     compared to reflux episodes while on continuous positive airway pressure ventilation.   "
179241|NCT00194402|"     Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this     research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and     together. This study will help show how the individual benefits of the two drugs taken     separately can be combined when taken together.   "
179242|NCT00194415|"     The objective of the study is to evaluate the acceptance and effect of type- specific HSV     serologic testing of pregnant women on sexual behavior at the end of pregnancy.   "
179243|NCT00194428|"     The purpose of this trial is to study the safety, tolerability and efficacy of an almond     enriched hypocaloric diet on weight loss and weight maintenance, as well as on established     and emerging cardiovascular risk factors in approximately 112 overweight and obese persons.   "
179244|NCT00194441|"     The aim of the initial proposal was to evaluate, in the context of optimal medical     management, the impact of a bedside system of cerebral perfusion pressure (CPP) information     feedback on nursing moment-to-moment management of CPP, and the relationship of that     management to patient functional outcome at discharge, 3 and 6 months. The primary hypothesis     being tested is that Glasgow Outcome Score (GOS) 6 months post acute care discharge will be     significantly better in those monitored with the continuous CPP display.      In the second phase of the study the adult study will be extended to children to determine if     there is a critical threshold for CPP in children following brain injury based on their     outcome at 3, 6, and 12 months. The primary outcome measure is the GOS at 12 months     post-injury. The GOS, Behavior Rating Inventory of Executive Function, and PedsQOL will also     be assessed at 3, 6, & 12 months, and the Adaptive Behavior Assessment System at 3 and 6     months post-injury. In addition, the researchers will examine variability and complexity of     physiologic measures, such as blood pressure, recorded during the intensive care unit stay of     adults and children enrolled in the study. The researchers will study the association of     these measures with risk for secondary brain injury and ability to predict differences in     outcome. The researchers will also assess the value individuals place on varying outcomes     following brain injury.   "
179245|NCT00194454|"     The primary aim of this study is to determine the effect of a nurse-delivered     psychosocial/behavioral intervention on reduction of depression in community dwelling     post-stroke patients. We expect the combined behavioral and pharmacologic intervention to be     more effective than pharmacotherapy alone in sustaining the improvement in depression for the     experimental group. Secondary aims are to examine the effect of the psychosocial/behavioral     intervention time course and sustainability of response to treatment, effect on limitations     in ability, limitation in participation and overall stroke impact in community-dwelling     post-stroke patients, and to compare ischemic stroke survivors who are and are not depressed     within the first four months following stroke by their 5-HTTLPR genotypes (s/s, s/l, or l/l).   "
179246|NCT00194467|"     The purpose of the study is to use valganciclovir to define the role of antiviral therapy in     suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that     valganciclovir will substantially reduce the frequency of detection and amount of HHV-8 in     the mouth.   "
179247|NCT00194480|"     Injection drug use accounts for transmission of a high proportion of Hepatitis C Virus (HCV)     infections. The purpose of this trial is to investigate the effectiveness of pegylated     interferon in treating injection drug users (IDUs) with acute HCV.   "
179265|NCT00194727|"     The primary purpose of the study is to examine the safety and effectiveness of combination     therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV     breast cancer subjects. The study is designed to assess the safety and effectiveness of this     combination therapy. Safety will be assessed by analyzing the types of toxicity, the severity     of toxicity and the need for dose modification or delay due to toxicity. Effectiveness will     be assessed by analyzing response rates, time to treatment failure, time to progression and     overall survival. Our hypothesis is that the regimen will be more effective than standard     historic regimens for this type and stage of cancer.   "
179256|NCT00194597|"     Viagra is a potent 5-PDE inhibitor that causes vasodilation in the penis and, therefore,     erection in men with erectile dysfunction. Our hypothesis is that Viagra may improve the     symptoms of men with Chronic Pelvic Pain Syndrome based on the following assumptions:      Chronic Pelvic Pelvic Syndrome and Interstitial Cystitis involve poorly understood central     and peripheral pain sensitization such as are seen in Chronic Sympathetic Dystrophy, also     called Chronic Regional Pain Syndrome. This pain may be caused by constricted blood vessels     resulting from past stress, injury or trauma      Viagra will dilate sympathetically constricted vessels and improve pelvic blood flow in the     same manner it does in men with erectile dysfunction.      Since men with Chronic Pelvic Pain Syndrome often complain of sexual dysfunction; improving     sexual function and, therefore, quality of life may improve overall well being and perception     of pain.   "
179399|NCT00196482|"     Double-blind randomized controlled trial to investigate the impact of two human milk     fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.      Two different compositions are tested, main difference is in electrolyte composiiton.   "
179248|NCT00194493|"     The traditional procedure for cancer symptom and quality of life instrument administration is     a paper questionnaire completed by the patient or research participant. The use of     standardized, patient report instruments as routine assessment in clinical cancer care has     been promoted, but infrequently reported and the utilization rate is low. Barriers to     clinical use include the personnel cost of data collection, management of written     questionnaires and the clinicians' unfamiliarity with the nature of the queries and numerical     scale scores. Web-based electronic technology now has been developed and tested for     feasibility using touchscreen, notebook computers and the computerized assessment program, a     screening assessment providing usable and easily interpreted graphic output to cancer     clinicians. The purpose of this study is to design and evaluate the clinical integration of     the web-based computerized assessment in a major, multi-disciplinary academic medical center     and cancer center. Consecutive outpatients who are evaluated for cancer therapy in each of     the 2 setting sites, the University of Washington Medical Center and the Seattle Cancer Care     Alliance, are able to communicate in English (or through one of the many interpreters     available at the institutions), and are competent to understand the study information and     give informed consent will be invited to participate. Clinicians caring for the patients in     the sample will be invited to participate in evaluating the organizational impact. We will     compare the outcomes of conducting assessment in the usual practices and procedures to the     outcomes of using the computerized assessment program: appropriateness of referrals,     efficiency, and usability. The computerized assessment will be completed prior to each     participant's visit with the clinician, conducted at the first clinic visit, during the 4-6th     week of treatment and again at a 30 day follow up visit. Graphical output will be immediately     available to clinicians. Descriptive, comparative statistics will be used to evaluate the     impact of the screening and longitudinal assessments.   "
179249|NCT00194506|"     This is a 12-month randomized, controlled trial of a Web-based diabetes co-management module     among type 2 patients at the University of Washington's Roosevelt General Internal Medicine     Clinic.   "
179250|NCT00194519|"     The University of Washington has received funding to conduct a proof-of-concept trial to     assess the impact of suppression of genital herpes on HIV infectiousness. This study (the     Partners in Prevention Study) will enroll HIV discordant heterosexual couples in which the     HIV-infected partner is co-infected with herpes simplex virus type 2 (HSV-2) to test the     efficacy of twice daily (bid) acyclovir (400 mg) given to the HIV-infected partner to prevent     transmission to his/her HIV negative partner(s). This randomized, double-blind,     placebo-controlled proof-of-concept trial will provide evidence for the efficacy of HSV-2     suppression with daily acyclovir on HIV transmission among HIV-discordant couples among whom     the HIV-positive partner is also HSV-2 seropositive with CD4 >250. The researchers hypothesis     is that, by decreasing the frequency and amount of genital HIV shedding, standard doses of     daily acyclovir 400 mg bid will reduce the rate of HIV transmission by 50% in HIV-discordant     couples among whom the HIV-infected partner is HSV-2 positive.      Under the study protocol version 4.1.1, 3000 HIV-discordant heterosexual couples in which the     HIV-positive partner is HSV-2 positive and has a CD4 count >250 will be recruited;     participants will be followed for up to 2 years. A 4% per year HIV incidence in the placebo     arm is assumed.      The first study site began enrolling participants on 17 November 2005. As of September 2006,     14 sites in Eastern and Southern Africa had participated in recruiting the 2300     HIV-discordant couples enrolled to date.   "
179251|NCT00194532|"     Urinary tract infection (UTI) is a very common problem in young healthy women, afflicting     approximately one-half of women by their late 20s. One of the most common antibiotics used to     treat UTIs is ciprofloxacin, usually for a total of three days. However, increasing     resistance to this antibiotic has raised concerns about its overuse for cystitis and     generated interest in alternative agents. An alternative antibiotic which is approved for use     in UTIs is cefpodoxime. However, there are few studies evaluating the efficacy and tolerance     of this compound when given in a 3-day regimen as is commonly used for treatment of UTI. The     major purpose of this study is to assess the efficacy and tolerance of a 3-day regimen of     cefpodoxime versus ciprofloxacin for treatment of acute uncomplicated cystitis.   "
179252|NCT00194545|"     Following significant reduction in antiretroviral drug prices over the past two years, more     HIV-1 infected African adults and children are gaining access to treatment. However, due to     complex drug regimens that have to be taken continuously, suboptimal adherence is likely to     be a formidable challenge. As programs providing antiretroviral drugs in Africa scale up,     achievement of excellent adherence is a high priority as this will result in maximum benefits     from the drugs and forestall development of resistant virus. A better understanding of     predictors of pediatric HAART adherence in African children is essential in order to     formulate feasible, culturally appropriate, strategies to monitor and enhance adherence.     There is also urgent need to evaluate simple, inexpensive interventions that are widely     applicable in the African setting. The medication diary has been used empirically among HIV     infected adults and children in Western countries, mainly as a tool for monitoring and to a     lesser extent improving HAART adherence. Literacy levels have risen significantly in most     African regions over the past few years, and the diary can also be further modified using     pictures to suit parents of different literacy levels. We propose to conduct a randomized     control trial to determine the effect of medication diaries and counseling versus counseling     alone on HAART-adherence in HIV-1 infected children and their parents/caregivers in Nairobi     Kenya.   "
179253|NCT00194558|"     The researchers will conduct a 12-month randomized controlled trial comparing usual care     versus chronic disease management using the Internet among patients with type 1 diabetes     receiving care in the Diabetes Care Center at the University of Washington.   "
179254|NCT00194571|"     This is a 6-state randomized controlled trial (RCT) that uses a behavioral intervention to     enhance parenting skills for school age children when a mother is recently diagnosed with     early stage breast cancer. Efficacy analyses will include measures of the child's and     mother's psychosocial adjustment, including enhanced parenting quality and skills related to     the cancer.   "
179255|NCT00194584|"     The long-term goal of this research is to strengthen parents' abilities to manage the     complexities of childhood chronic illness. To achieve this goal, the team of parents, health     care professionals, and researchers proposes the following specific aim:        -  Develop, implement, and test a unique psycho-educational program, Living with Childhood          Chronic Illness (the Program), for effectiveness with parents of children who have          chronic illnesses.      The investigators propose the following hypotheses:      At both 6 and 12 month follow-up points, parents taking part in the intervention, in contrast     to control parents, will have:        1. Greater perceived self-efficacy regarding their ability to manage the child's chronic          condition;        2. Greater parental ability to involve their child in shared management activities;        3. Greater parental ability to cope at 6 and 12 months following the end of the          intervention;        4. Greater emotional health; and        5. Greater parental perceived family quality of life.   "
179257|NCT00194610|"     Patients with interstitial cystitis have been well documented to have pelvic floor muscle     tenderness as well as pain on bladder distension. Some investigators have even suggested that     pelvic floor muscle pain is primarily the cause of bladder problems.      Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the     neuromuscular junction. It has been shown that this mechanism relieves pain in a number of     muscle spasm-related syndromes.      Because, at present, there is little effective therapy available for patients with     interstitial cystitis, the researchers want to determine if botulinum toxin A will relieve     bladder and pelvic pain in these patients.   "
179258|NCT00194623|"     Chronic pelvic pain syndrome (CPPS) is thought to affect approximately 8% of men aged 18 and     older. Patients with this condition experience pain in the perineum, the genitalia, and the     rectum. As well, there is associated voiding, sexual, and ejaculatory dysfunction. The impact     of patient well-being is thought to be equivalent to patients with congestive heart failure.     The etiology of this condition is unknown, thus making treatment very difficult. Researchers     have pursued an infectious cause for the disease; however, studies have failed to     substantiate this theory. Despite this, the main treatment offered to patients is long-term     antibiotic therapy. Results from this treatment modality have been unsatisfactory.      Other groups have postulated that the symptoms of CPPS may be secondary to neuromuscular     factors. Some studies have demonstrated increases in pelvic muscular tone. Maneuvers such as     prostate massage and levator massage have shown some benefit in relieving symptoms. Treatment     with alpha-blockers to relax prostate smooth muscle has brought about improvement in a     portion of patients. Use of generalized muscle relaxants has produced mediocre results.      However, many of these neuromuscular treatments are generalized and do not target the     perineal musculature directly. It is theorized that spasm of the perineal muscles triggered     by an unknown noxious stimuli (e.g. infection) cause the pain and symptoms of CPPS. At our     center, we have performed pilot studies using botulinum toxin A. Four patients were treated     with Botox. 100 U were injected in three locations in the midline of the bulbocavernosus     muscle. The bulbocavernosus muscle is easily accessible and shares innervation with the     pelvic musculature. Patient's response to medication was measured by the NIH Prostatitis pain     scale and as well as the University of Washington prostatitis pain scale. All patients     reported resolution of symptoms. Remission lasted for duration of 10-12 weeks. No patients     reported adverse events.      HYPOTHESIS      Botulinum toxin A is effective in the treatment of chronic pelvic pain syndrome in men.   "
179259|NCT00194636|"     The purpose of this study is to investigate, by means of a temporary sympathetic nerve block,     the involvement of the sympathetic nervous system in Chronic Pelvic Pain Syndrome (CPPS).     This study may also result in a new therapeutic approach for male CPPS.   "
179260|NCT00194649|"     The purpose of this research study is to help in the development of safe, effective and     reversible male contraception. We are examining the impact of the drug Miglustat on sperm     production in normal men.      We want to see if Miglustat will inhibit sperm production in men and act as a reversible male     contraceptive, as a study in mice administered Miglustat showed a reversible inhibition of     sperm production. We believe Miglustat may have some potential as a safe, reversible male     contraceptive.   "
179261|NCT00194675|"     The purpose of this research study is to determine whether the combination of the male     hormone testosterone [T] in gel form and the oral drug dutasteride [D], used to shrink large     prostate glands can safely reduce the size of the prostate gland and symptoms of prostate     enlargement (called benign prostatic hyperplasia [BPH]) compared to T treatment alone in men     with low testosterone (called hypogonadism).   "
179262|NCT00194688|"     The objective is to evaluate the utility of a breath ammonia sensing device. In this study we     will assess the effect of H. pylori infection on breath ammonia levels by measuring whether     there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive     patients compared to H. pylori negative patients.   "
179263|NCT00194701|"     Of the more than 2 million Americans with heart failure (HF), up to 70% have disturbed sleep     that worsens the dyspnea, fatigue, and reduced daytime function associated with HF. Exercise     improves sleep in healthy people but the effects of exercise have not been tested in patients     with HF. A controlled, randomized trial is proposed to compare the effects of 16 weeks of     usual activity (control) with 16 weeks of regular, supervised walking exercise (treatment),     on cardiac function and sleep. Approximately 170 subjects with NYHA Class I, II, or III     stable heart failure will be recruited. Subjects in the treatment group will walk for     exercise up to 5 times a week for up to 30 minutes.      The purpose of this randomized trial is to examine the effects of 16 weeks of regular walking     exercise on cardiac function, sleep, and quality of life in persons with stable New York     Heart Association (NYHA) Class I, II or III heart failure.      The specific aims are:        1. To compare the physiologic measures of cardiac function (peak oxygen utilization,          exercise capacity, nocturnal arterial oxygen desaturations, and heart rate variability)          and self-reported quality of life (i.e., symptoms of dyspnea and fatigue, and the          ability to perform activities of daily living) of patients randomized to walking vs.          control condition.        2. To compare the somnographic (sleep fragmentation, slow wave sleep, sleep efficiency) and          self-reported (sleep effectiveness, sleep disturbance, and nap supplementation) measures          of sleep for HF patients randomized to walking vs. control condition.        3. Considering the extent of apnea-hypopnea episodes at study entry and group assignment          (walking vs. control), explore whether HF patients with frequent apnea-hypopnea episodes          (more than 20 per hour) in the walking group experience greater pretest-posttest          improvements in physiologic cardiac and somnographic function, when compared with HF          patients with few apnea-hypopnea episodes (less than 20 per hour) assigned to walking,          or the control group of HF patients with frequent or few apnea-hypopnea episodes.      HYPOTHESES:        1. Heart failure patients who walk regularly will have better cardiac function than the          control group.           Heart failure patients who walk regularly will have higher self-reported quality of          life, less shortness of breath/fatigue, and greater ability to perform activities of          daily living than the control group.        2. Heart failure patients who walk regularly will have better sleep than the control group.        3. Heart failure patients with frequent episodes of slowed or stopped breathing during          sleep who walk regularly will have a greater improvement in pretest-posttest measures of          cardiac function than heart failure patients with few episodes of slowed or stopped          breathing during sleep who walk regularly, or the control groups with frequent or few          breathing difficulties during sleep.      Heart failure patients with frequent apnea-hypopnea episodes who walk regularly will have a     greater improvement (i.e., larger difference) in pretest-posttest somnographic sleep measures     of efficient, fragmented, and slow wave sleep, than heart failure patients with few     apnea-hypopnea episodes who walk regularly, or the control groups with frequent or few     apnea-hypopnea episodes.   "
179264|NCT00194714|"     This phase I/II trial studies the side effects of vaccine therapy and to see how well it     works in treating patients with stage IV major histocompatibility complex, class I, A2     antigen (HLA-A2) and human epidermal growth factor receptor 2 (HER2) positive breast or     ovarian cancer who are receiving trastuzumab. Giving booster vaccines made from HER2 peptides     may help increase HER2 specific immunity and immune memory cells.   "
179266|NCT00194740|"     The two drugs used to treat metastatic breast cancer in this study may perform better when     used together than when used separately. The use of another drug that prevents the most     common side effect of the two-drug combination permits the delivery of both agents at closer     to the full dose for either when used alone. We hypothesize that the two-drug combination     used with G-CSF support will be more effective and less toxic than other standard regimens     for the treatment of metastatic breast cancer.   "
179267|NCT00194753|"     The primary objectives of the study are to evaluate the feasibility and toxicity of treatment     with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks     of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug     to the delivered dose intensity in previous trials. Toxicity will be assessed by comparing     the incidence and severity of toxicity with these drugs to previous trials using these drugs     in the same combination. We hypothesize metronomic, dose dense treatment as given in this     study will be less toxic and more effective than historical regimens using the same drugs in     a less metronomic, dose dense manner.   "
179268|NCT00194766|"     The purpose of this study is to determine whether treatment with temozolomide can effect the     survival of patients with advanced breast cancer or soft tissue sarcoma.   "
179269|NCT00194779|"     This phase II trial studies how well giving combination chemotherapy and filgrastim together     before surgery works in treating patients with human epidermal growth receptor 2     (HER2)-positive breast cancer that can be removed by surgery. Drugs used in chemotherapy,     such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving combination chemotherapy before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed. Colony-stimulating factors, such     as filgrastim, may increase the number of immune cells found in bone marrow or peripheral     blood and may help the immune system recover from the side effects of chemotherapy. Giving     doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel     before surgery may be an effective treatment for breast cancer   "
179270|NCT00194792|"     This phase II trial is studying how well giving hormone therapy together with combination     chemotherapy before and after surgery works in treating patients with stage I-IIIA breast     cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using     exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen     the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine     ditartrate, and paclitaxel, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving hormone therapy together with     combination chemotherapy before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed. Giving these treatments after surgery may kill any     tumor cells that remain after surgery   "
179271|NCT00194805|"     This study will examine the feasibility and short and-long-term efficacy of a web-based     telehealth intervention with community-dwelling older adults who have been diagnosed with     type 2 diabetes. Effectiveness will be evaluated using multiple measures within three     different domains: 1) physical (glycosylated hemoglobin [HbA1C], weight, and lipid levels);     2) behavioral (monitoring blood glucose levels, feet inspections, diet, and exercise     frequency), and 3) psychosocial (depression, quality of life, social support, and adjustment     to diabetes).      This is a randomized controlled trial of a web-based telehealth intervention designed to     improve self-management behaviors in a group of community dwelling older diabetics. Two     groups of participants will be recruited and randomized over a four-month period during years     01 and 02. Participants in the control group will receive standard diabetic care provided by     their provider. Participants in the intervention group will receive computer training in the     participant's home in how to access and utilize the web-based telehealth study webpage. The     intervention will consist of a program designed and delivered via the Internet to improve the     participants' diabetes self-management behaviors using behavioral and motivational strategies     and cues to modify perceptions of self-efficacy and beliefs regarding the ability to affect     the progress of the disease and change personal behavior.   "
179272|NCT00194818|"     We, the investigators at University of Washington, plan on evaluating the effect of open     label Asacol at a dose of 4.8 grams/day divided BID (twice per day) or TID (three times per     day) on its ability to induce remission in patients with mild to moderately active ulcerative     colitis. We hypothesize that both regimens will have the same efficacy and no difference in     side effects.   "
179273|NCT00194831|"     The study will correlate the volumes of the brain obtained from magnetic resonance imaging     (MRI) scans done at term gestation for infants born prematurely who weighed less than 1000     grams at birth with their corresponding development at 18 months corrected age.   "
179274|NCT00194844|"     This is a randomized trial of three caring based interventions to see if we can help couples     heal after miscarriage. All three are based on Swanson's theory of caring and Meaning of     Miscarriage Model. The first, nurse caring, consists of three counseling sessions with a     nurse. The second intervention, self-caring, involves watching three videotapes and     completing three workbooks. The third, combined caring, involves receiving one counseling     session with a nurse followed up with the three videotapes and workbooks. There is also a     control group that receives no intervention. All interventions are administered at 1, 6, and     11 weeks after study enrollment. Couples can enroll who are no more than 12 weeks post     miscarriage of a pregnancy that ended at 20 weeks gestation or less. At 1, 6, 16, and 52     weeks post enrollment we ask couples to complete mailed booklets that contain a variety of     research questionnaires about their emotional health, integration of loss, and couple     relationship.   "
179275|NCT00194857|"     This study is designed to test two separate strategies for treatment of anemia (low     hemoglobin) and neutropenia (low white blood cells) in HIV/HCV coinfected patients who are     being treated with pegylated interferon and ribavirin.   "
179276|NCT00194870|"     Patients with epilepsy undergoing deep brain stimulation (DBS) have electroencephalograms     (EEGs) recorded before and during their stimulation treatment. Subsequently the investigators     will be using computer-assisted analysis of the digitally-recorded EEG signals to assess the     effects of DBS on the brain-wave frequency content and any abnormal seizure-like patterns     that may be present.   "
179277|NCT00194883|"     Children with chronic kidney failure often do not grow well. This study examines the possible     causes of growth failure in these children and the response to recombinant human growth     hormone. The growth hormone-insulin-like growth factor axis will be studied in relation to     biochemical and immunological parameters as well as body compositional changes pre- and post     recombinant human growth hormone therapy.   "
188157|NCT00307658|"     The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing     remission in patients relapsing of systemic vasculitides.   "
179279|NCT00194909|"     The purpose of this study is to study if sildenafil (Viagra) is effective in improving     neuropathic pain. This will be an open label study at 3 doses of sildenafil (25 mg, 50 mg and     100 mg). If this study suggests efficacy, the information will be used to plan a placebo     controlled, double-blind study in the future.   "
179280|NCT00194922|"     The purpose of this study is to determine the tolerance and efficacy of the probiotic E. Coli     Strain M17 on symptoms and Quality of Life in Individuals with Irritable Bowel Syndrome     (IBS).   "
179281|NCT00194935|"     The purpose of this study is to find out the safety and feasibility of weekly topotecan     consolidation therapy in patients with ovarian cancer.   "
179283|NCT00194961|"     Circulating concentrations of cytokines, such as leptin, tumor necrosis factor-alpha and     interleukins 1 and 6 are increased in patients with chronic kidney disease (CKD). In light of     the increasing recognition that growth hormone receptor signaling involves cytokine pathway     activation, the investigators hypothesize that maladaptation of cytokine regulation in     chronic kidney disease may underlie growth failure. Secondly, they hypothesize that     administration of recombinant human growth hormone (rhGH) will result in growth rate     stimulation in pre-pubertal children with growth impairment due to chronic kidney disease by     down regulation of the cytokine pathways.      This is a non-randomized open-label study to evaluate the effect of recombinant human growth     hormone on biochemical/metabolic and immunologic parameters in relation to body composition     pre- and post-recombinant human growth hormone therapy of pre-pubertal growth hormone naive     children. The efficacy of recombinant human growth hormone to improve growth velocity in     pre-pubertal children with growth failure is a secondary objective. Fifteen children are to     be studied over a six month period. Each patient will serve as his/her own control. Six     months of growth data prior to study is required.   "
179284|NCT00194974|"     This project is a clinical study of women with high blood pressure who become pregnant.     Preeclampsia is a syndrome developing at the end of a pregnancy characterized by an abrupt     rise in blood pressure (BP), blood clotting and kidney dysfunction, and may result in     premature delivery, infant death, and maternal bleeding, kidney failure and stroke. The goal     is to determine whether lowering blood pressure to a normal pressure of 120/80 is associated     with a lower incidence of preeclampsia. Women who are completely healthy have a 5% chance of     developing preeclampsia, however women with preexisting high blood pressure have a 25% chance     of this complication. Several studies, including our own suggest that higher blood pressure     early in pregnancy (<20 weeks) is associated with an even higher risk of preeclampsia.     Currently we, the researchers at Weill Medical College of Cornell University, do not know how     to treat women with high blood pressure and/or kidney disease during pregnancy. Keeping the     BP in the normal range may be beneficial to the mother. On the other hand, we are not sure if     the blood pressure lowering or the medications may or may not have adverse effects for the     baby. Different trials to answer this question have been performed with no clear conclusions.     Because of these uncertainties, we propose to compare two different strategies for treating     women with high BP who become pregnant. We will treat half the women with BP medications to     normalize BP (120-130/80 mm Hg) (experimental group) and the other half with the goal of     keeping the BP slightly higher (140-150/90-100 mm Hg)(standard therapy group). We will     determine which approach results in healthier pregnancies, and lower incidence of     preeclampsia. Reducing the incidence of preeclampsia would be of significant benefit to both     mothers and babies.   "
179285|NCT00194987|"     The purposes of this study are to provide medical management by giving treatment to the     mother that will bring up the fetal platelet count and to minimize the number of invasive     procedures to the fetus (which may result in serious fetal injuries).   "
179286|NCT00195000|"     The purpose of this study is to find out how safe and effective the combination of Mylotarg     in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and     advanced Myelodysplastic Syndrome over the age of 60 years.   "
179287|NCT00195013|"     Patients with breast cancer receiving paclitaxel chemotherapy who have mild symptoms of     peripheral neuropathy will receive glutamine or placebo to try and improve symptoms.   "
179288|NCT00195026|"     This protocol will evaluate a new non-invasive infrared imaging system as an adjunctive tool     for breast cancer detection that has been approved by the FDA. The technology and device have     been developed by Infrared Sciences Corp. and has undergone more than 3 years of testing     prior. The subject device's utility will be investigated with regard to its sensitivity     toward breast cancer, however it records temperature data and other physiological parameters     of the breast, and compares them to a database of patients with known breast health.   "
179289|NCT00195039|"     The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of     patients with metastatic, androgen-independent prostate cancer.   "
179290|NCT00195052|"     The purpose of this study is to develop a technique for the intraoperative identification of     human functional and epileptiform cortex using intrinsic signal imaging. The investigators     propose that the ability to optically monitor neuronal activity in a large area of cortex in     real-time will be a more sensitive and time-saving method than the electrical methods     currently available. The applications of this technique will not only theoretically increase     the safety and efficacy of many of neurosurgical procedures, but will be useful as an     investigational tool to study human cortical physiology.   "
179291|NCT00195065|"     To explore and illuminate the cultural, social, and psychological factors that either     facilitate or serve as barriers to behavioral change in asthma patients.   "
179292|NCT00195078|"     The purpose of this study is to find out whether adding ZD1839 to standard treatment     (Cisplatin and Radiation Therapy) of unresectable head and neck cancers is better than     cisplatin and radiation alone.   "
179333|NCT00195611|"     The aim of this study is to assess in France the impact of Prevenar on the possible evolution     of the pneumococcal serotypes distribution and antibiotic resistance in NP samples of     children with AOM.   "
179334|NCT00195624|"     This study will evaluate the safety and usefulness of a new immunosuppressive drug,     alemtuzumab (Campath ), in patients with severe aplastic anemia (SAA). SAA is a rare and     serious blood disorder in which the bone marrow stops making red blood cells, white blood     cells and platelets. Alemtuzumab is a monoclonal antibody that attaches to and kills white     blood cells called lymphocytes. In certain types of aplastic anemia, lymphocytes are     responsible for the destruction of stem cells in the bone marrow, leading to a decrease in     blood counts. Because alemtuzumab destroys lymphocytes, it may be effective in treating     aplastic anemia. Alemtuzumab is currently approved to treat chronic lymphocytic leukemia and     is also helpful in other conditions that require immunosuppression, such as rheumatoid     arthritis and immune cytopenias.      Patients 2 years of age and older with severe aplastic anemia whose disease does not respond     to immunosuppressive therapy or has recurred following immunosuppressive therapy may be     eligible for this study. Participants undergo the following tests and procedures:        -  Pretreatment evaluation: Patients have a medical history, physical examination, blood          tests, electrocardiogram (EKG), echocardiogram, 24-hour Holter monitor (continuous          24-hour monitoring of electrical activity of the heart), bone marrow biopsy (withdrawal          through a needle of a small sample of bone marrow for analysis).        -  Placement of a central line, if needed: An intravenous line (tube) is placed into a          major vein in the patient's chest. It can stay in the body for the entire treatment          period and be used to give chemotherapy or other medications, including antibiotics and          blood transfusions, if needed, and to withdraw blood samples.        -  Alemtuzumab therapy: Patients are admitted to the NIH Clinical Center for the first few          injections for close monitoring of side effects. After receiving an initial small test          dose, patients begin the first of ten daily injections under the skin, each lasting          about 2 hours. Once patients tolerate the infusions with minimal or no side effects,          they may be given the remaining infusions on an outpatient basis. Patients who relapse          after their initial response to alemtuzumab are given cyclosporine to see if this drug          will boost their immune response.        -  Patients receive transfusions, growth factors, and antibiotic therapy, as needed.        -  Infection therapy: Patients are given aerosolized pentamidine to protect against lung          infections and valacyclovir to protect against herpes infections.        -  A blood test is done and vital signs are measured every day while patients receive          alemtuzumab.        -  Patients have an echocardiogram and 24-hour Holter monitor after the last dose of          alemtuzumab.        -  Blood tests are done weekly for the first 3 months after alemtuzumab administration,          then every other week until 6 months.      Patients return to the NIH for follow-up visits 1 month, 3 months, 6 months, and yearly for 5     years after the last dose of alemtuzumab for the following tests and evaluations:        -  Blood test        -  Repeat echocardiogram at 3-month visit        -  Repeat bone marrow biopsy 6 months and 12 months after alemtuzumab, then as clinically          indicated for 5 years.   "
179394|NCT00196417|"     Randomised, double blind trial in non-intensive care trauma patients comparing unfractionated     heparin (UFH) or low-molecular-weight heparin (LMWH) in heparin-induced thrombocytopenia     (HIT).   "
179293|NCT00195091|"     Patients with moderate to high risk primary breast cancer (Stage II with more than 4 lymph     nodes involved with cancer) III or Stage IV (without evidence of disease) will take     tetrathiomolybdate (TM) pills for two years.      The objectives of the study are to:        -  Assess the safety and tolerability of tetrathiomolybdate in patients with breast cancer          at high risk of tumor recurrence.        -  Observe the disease-free survival of patients in this trial.        -  Conduct background scientific experiments on tumor tissue and blood of patients in this          study   "
179294|NCT00195104|"     The purpose of this study is to find out the effectiveness and side effects of arsenic     trioxide in combination with low-dose ara-C.   "
179295|NCT00195117|"     The primary objective of this randomized trial is to evaluate a novel intervention of induced     positive affect and induced self-affirmation to increase physical activity in patients with     asthma.   "
179296|NCT00195130|"     The primary objective of this prospective study is to develop a new method of classifying the     prognosis of ambulatory patients according to their risk of long term mortality,     institutionalization, morbidity (including the deterioration of pre-existing conditions or     development of new problems) and functional deterioration.   "
179297|NCT00195143|"     The purpose of this study is to determine the safety of using a modified virus to transfer a     gene called GAD into a region of the brain called the subthalamic nucleus in patients with     advanced Parkinson's disease. The overall goal of this approach is to ultimately normalize     the flow of information in several brain regions responsible for movement, to ultimately     improve function in patients with this disorder. The current study is primarily designed to     evaluate the safety of this approach, but patients are also being monitored for possible     signs of effectiveness as well.   "
179298|NCT00195156|"     The purpose of this study is to find out the highest tolerated dose of Depakote in     combination with liposome encapsulated all-trans retinoic acid (ATRA-IV) in patients with     advanced solid tumor malignancies.   "
179299|NCT00195169|"     This is an observational study to determine the association between social support and     functional status after a myocardial infarct   "
179300|NCT00195182|"     The specific aims for this study are:        1. To examine the relationship between perceived racism and medication adherence among          hypertensive African-American patients.        2. To determine if psychological stress and depression mediate the relationship between          perceived racism and medication adherence.   "
179301|NCT00195195|"     The purpose of this study is to gather information about the long-term effects and safety of     treatment with Rapamune in transplant patients.   "
179302|NCT00195208|"     The purpose of this study is to demonstrate pharmacodynamic comparability between the     pantoprazole spheroid formulation and the marketed tablet formulation.   "
179303|NCT00195221|"     Retrospective, multicenter study in patients with hemophilia B. This study will be placed at     20 to 50 hemophilia treatment centers in North America and the EU, and is designed to     estimate the frequency of Class II and III allergic reactions in association with the     administration of any FIX concentrate.      Following informed consent and eligibility, historical patient information including     demographics, allergy history, hemophilia history, frequency and severity of allergic     reaction(s), number of exposure days with products causing allergic reactions, exposure days     to blood products including FIX concentrates, treatment for allergic reaction(s), outcome of     event(s), any other adverse event(s) occuring within 48 hours of onset of allergic     reaction(s), rechallenge and outcome, switch to another FIX product (if applicable) and     outcome, current status of patient, and results of any special studies (eg, skin or RAST     testing, alloantibody analyses, ect) will be collected.   "
179304|NCT00195234|"     The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are     used to help improve immune responses) have an acceptable safety profile in treating     individuals with HIV.      A second purpose of this study is to understand how the immune system responds to the study     vaccine and adjuvants.   "
179305|NCT00195247|"     The purpose of this study is to evaluate the safety, tolerability, and maximum tolerated dose     (MTD) of TTI-237 for the treatment of subjects with advanced malignant solid tumors.   "
179306|NCT00195260|"     To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily     schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated     dose (MTD) in this subject population.   "
179307|NCT00195273|"     The purpose of this study is to compare the kidney function in patients who have received a     transplanted kidney and were treated with the combination of sirolimus, daclizumab,     mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine,     mycophenolate and corticosteroids.   "
179308|NCT00195286|"     The primary objective is to study the efficacy of piperacillin/tazobactam in patients with     complicated urinary tract infections   "
179309|NCT00195299|"     This is an open-label, exploratory, biomarker study of intravenous temsirolimus given once     weekly for 3 weeks to newly diagnosed, advanced stage head and neck cancer subjects prior to     beginning their standard therapy for their specific disease. The primary objective of this     study is to identify biomarkers of temsirolimus activity.   "
179310|NCT00195312|"     The main purpose of this study is to learn whether the study vaccine and the adjuvants(drugs     that are used to help immune response) have an acceptable safety profile in treating     individuals with HIV.      A second purpose for this study is to understand how your immune system responds to the study     vaccine with the adjuvants. Understanding these differences could be useful in several ways.     First, it might help identify people whose disease is likely to respond to the study vaccine     with the study adjuvants. Second, the information might be useful in developing other     treatments for people whose disease does not respond to the study vaccine with the adjuvants.   "
179311|NCT00195325|"     The purpose of this study is to evaluate the safety, tolerability, and MTD (maximum tolerated     dose) of TTI-237 for the treatment of subjects with advanced malignant solid tumors.   "
179312|NCT00195338|"     The purpose of the study is to determine the long term safety of Enbrel in adults with active     rheumatoid arthritis in Luxemburg. This is a post-marketing surveillance study in     rheumatology practice patients. All patients initiated with Enbrel will be observed from the     start of the study in Feb 2003 for a period of at least 5 years.   "
179313|NCT00195351|"     This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and     efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects     with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms     of cIAI will be included for enrollment. Subjects will be stratified at randomization for     Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10.     Subjects will be followed for efficacy through the test-of-cure assessment. Safety     evaluations will occur through the treatment and post-treatment periods and continue through     resolution or stability of the adverse event(s).   "
179314|NCT00195364|"     The purpose of this study is to evaluate long-term safety of etanercept in patients with     rheumatoid arthritis who successfully have completed open-label safety study 0881A1-301-EU   "
179315|NCT00195377|"     The purpose of this study is to assess the safety of etanercept in patients with rheumatoid     arthritis (RA), juvenile idiopathic arthritis (JIA) or psoriatic arthritis (PsA) in Spain   "
179316|NCT00195390|"     The purpose of this study is to identify the following problems and questions with respect to     the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar,     during the post-marketing period in Korea, as required by Korea Food and Drug Administration     (KFDA) regulations.        1. Adverse reactions (especially serious adverse reactions)        2. Incidences of adverse reactions under routine vaccine use        3. Factors that may affect the safety of the vaccine   "
179317|NCT00195403|"     The objective of this investigation is to identify the following problems and questions with     respect to the safety and efficacy of Enbrel during the post-marketing period as required by     Korea Food and Drug Administration (KFDA)'s regulation.        1. Unknown adverse reactions, especially serious adverse reactions        2. Incidences of adverse reactions under routine drug uses        3. Factors that may affect the safety of the drug        4. Factors that may affect the efficacy of the drug      This investigation spanned 3 different studies, 0881A-101575 (alias B1801105) NCT00195403,     0881A-102018 (alias B1801112) NCT00195416 and 0881A-102212 (alias B1801113). All studies have     been combined into this record.   "
179318|NCT00195416|"     To identify the following problems and questions with respect to the safety and effectiveness     of Enbrel during the post-marketing period as required by Korea Food and Drug Administration     (KFDA)'s regulations.        1. Unknown adverse reactions, especially serious adverse reactions        2. Change of the incidences of adverse reactions under the routine drug uses        3. Factors that may affect the safety of the drug        4. Factors that may affect the effectiveness of the drug   "
179319|NCT00195429|"     This study evaluates two different immunosuppression drug regimens in patients with a recent     kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and     Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.   "
179320|NCT00195442|"     The purpose of this study is to investigate the effectiveness and safety of treatment with     ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment     will be done.   "
179321|NCT00195455|"     The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous     regimen 17 b estradiol/trimegestone combination.   "
179322|NCT00195468|"     Compare kidney function as measured by calculated creatinine clearance (using the method by     Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with     cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with     subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation     (Group II).   "
179323|NCT00195481|"     To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing     surveillance setting.   "
179324|NCT00195494|"     To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change     and clinical disease activity in subjects with early RA over 12 months.   "
179325|NCT00195507|"     This study will provide a direct comparison of 'continuous therapy' and 'intermittent     therapy' with withdrawal and retreatment upon return of psoriasis.   "
179326|NCT00195520|"     To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg     administered to a population of Brazilian women in a continuous combined regime for hormone     replacement therapy.   "
179327|NCT00195533|"     The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam     versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for     fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be     included in the monotherapy branch until completing the predicted number of cases. When this     happens, the Coordinating Center will communicate it to the participant centers and from then     the patients will be included in the combined therapy.   "
179328|NCT00195546|"     Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment     of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence     of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on     changes from baseline in weight, breast pain, and health outcomes indicators.   "
179329|NCT00195559|"     The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE)     is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.   "
179330|NCT00195572|"     The purpose of the study is to verify non-inferiority of survival time between     Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable     advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of     responses, time to progression (TTP) safety and quality of life (QOL).   "
179331|NCT00195585|"     The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of     relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary     endpoints include disease-free survival time, survival time, and safety.   "
179332|NCT00195598|"     The purpose of this pilot study is to evaluate the improvement in social function following     therapy with venlafaxine extended release (XR) in the treatment of panic disorder (PD) in     comparison to paroxetine. An additional purpose of this pilot study is to obtain the     tolerability of using venlafaxine extended release (XR) in the treatment of panic disorder     (PD) in comparison to paroxetine.   "
179354|NCT00195897|"     Anthracycline-based chemotherapy is a key point of the treatment of patients with Hodgkin's     and non-Hodgkin's lymphomas. However, cumulative doses are limited by cardiotoxicity,     resulting in a marked left ventricular function impairment that may lead to heart failure.      The standard clinical approach to monitoring for anthracycline cardiotoxicity is based on     cardiac function monitoring using echocardiography or radionuclide angiography. The aim of     this study is to evaluate the usefulness of biochemical markers of cardiac injury (troponin     and NT-proBNP) and structural changes on cardiac MR in predicting anthracycline     cardiotoxicity.   "
179355|NCT00195910|"     To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a     standard weight-based dose of IV morphine in adults presenting to the ED with acute severe     pain.   "
179356|NCT00195923|"     The purpose of this study is to compare traditional triple antibiotic therapy against dual     single day dosing antibiotic therapy in the management of perforated appendicitis in     children.   "
179335|NCT00195637|"     This study will evaluate patients with Hereditary Inclusion Body Myopathy (HIBM) and examine     the effects of immune globulin (IG) treatment on muscle and muscle function. HIBM is a     progressive neuromuscular disease that begins in early adulthood, primarily affecting limb     muscles. It results from mutations of the gene that is responsible for producing sialic acid,     a sugar normally found on the surface of certain proteins, including alpha-dystroglycan,     which is involved in muscle function. Some patients with HIBM have decreased sialic acid on     the alpha-dystroglycan protein, which may be the cause of their muscle weakness. IG is a     protein in the blood that carries a large amount of sialic acid. This study will administer     IG to patients with HIBM and determine if the sialic acid in IG is taken up by muscle cells     in these patients and if it can restore some of their muscle function.      Four patients with HIBM will be admitted to this study at the NIH Clinical Center for     evaluation and IG treatment. The evaluation lasts about 1 month. After completing baseline     studies (see below), patients receive two intravenous doses of immune globulin (on days 6 and     7), followed by measurement of muscle strength 2 days later (day 9). They receive additional     IG infusions on days 13, 20, and 27. A final set of tests is performed on day 29. Patients     may leave the hospital on pass when no studies are being done.      A patient's initial evaluation includes:        -  History and physical examination, neurological examination, eye examination        -  24-hour urine collection        -  Blood tests on two separate days        -  Photographs showing the extent of muscle affected        -  Chest x-ray, electrocardiogram (EKG), and echocardiogram        -  Two muscle biopsies, one before and one after the IG treatments. For this procedure, a          small sample of muscle tissue is surgically removed for examination under the          microscope.        -  Muscle strength and endurance testing, including the following:      The patient uses pulleys attached to machines that measure the strength of 24 different     muscle groups      The patient walks for 6 minutes and performs exercises      To evaluate swallowing, the patient swallows a thick substance called barium      The patient's tongue strength is measured using a specialized instrument.      -Magnetic resonance imaging (MRI) of the muscles of the thigh or calf: MRI uses a magnetic     field and radio waves to produce detailed pictures of organs and tissues. During the scan,     the subject lies on a table in a narrow cylinder containing a magnetic field, wearing ear     plugs to muffle loud noises that occur with electrical switching of the magnetic fields. He     or she can speak with a staff member via an intercom system at all times during the     procedure.      The neurological and muscle strength and endurance evaluations are repeated on study days 9     and 29.   "
179336|NCT00195650|"     The purpose of the study was to assess the long-term safety and clinical efficacy following     repeated administration of adalimumab in patients with rheumatoid arthritis.   "
179337|NCT00195663|"     The purpose of the study is to assess the safety and efficacy of adalimumab in combination     with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the     long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10     years.   "
179338|NCT00195676|"     The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab     treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate     the effectiveness of adalimumab retreatment in participants who had therapeutic response to     adalimumab and were then withdrawn from adalimumab treatment.   "
179339|NCT00195689|"     The purpose of the study is to assess the long-term safety and clinical efficacy of     adalimumab in treatment of moderate to severely active psoriatic arthritis   "
179340|NCT00195702|"     The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of     adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term     safety and maintenance of efficacy following repeated administration of adalimumab (during     open-label extension phase) in patients with persistently active rheumatoid arthritis who     were receiving concurrent methotrexate therapy.   "
179341|NCT00195715|"     To evaluate the long-term maintenance of response, safety and tolerability of repeated     administration of adalimumab in subjects with Crohn's disease who participated in and     successfully completed Protocol M02-404 or Protocol M04-691.   "
179342|NCT00195728|"     The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and     acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low     back pain.   "
179343|NCT00195741|"     The purpose of this study is to determine whether Depakote ER is safe and effective in the     reduction of occurrence of migraine headaches in adolescents.   "
179344|NCT00195754|"     The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote     ER is safe in the reduction of occurrence of migraine headaches in adolescents.   "
179345|NCT00195767|"     To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective     in the treatment of bipolar I disorder in children and adolescents.   "
179346|NCT00195780|"     The purpose of the study is to evaluate the long-term safety profile of the Investigational     Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in     children and adolescents ages 10-17.   "
179347|NCT00195793|"     The objective of this study is to evaluate the effects of adding Tricor 145 mg to once daily     atorvastatin 20 mg on CHD lipid laboratory parameters.   "
179348|NCT00195806|"     The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote     ER is safe in the reduction of occurrence of migraine headaches in adolescents.   "
179349|NCT00195819|"     The purpose of the study is to assess the safety and clinical efficacy of adalimumab in     subjects with active ankylosing spondylitis   "
179350|NCT00195845|"     The purpose of this study is to determine if galantamine augmentaion improves cognition in     euthymic bipolar patients. In addition, the effect of galantamine on clinical measures of     functioning and psychopathology will also be assessed.   "
179351|NCT00195858|"     The purpose of this study is to evaluate the effects of resistance training, aerobic     training, and combined aerobic and resistance training on percent body fat, measured using     Magnetic Resonance Imaging (MRI), in sedentary post-pubertal overweight or obese youth aged     14-18 years.   "
179352|NCT00195871|"     The primary objective of this study is to evaluate the safety and the efficacy of an adult     acute lymphoblastic leukaemia type chemotherapy in patients less than 60 years with     lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed     intensification.   "
179353|NCT00195884|"     The main purpose of this study is to assess the impact of exercise training (aerobic     exercise, resistance exercise, combined aerobic and resistance exercise) versus a sedentary     waiting list control on glycemic control (as reflected in reduced hemoglobin A1c [HbA1c]),     body composition (weight, body mass index [BMI], waist circumference, total body fat,     visceral and subcutaneous abdominal fat, mid-thigh muscle cross-sectional area), lipids     (Apo-B, Apo-A1, Apo-B/A1 ratio, low density lipoprotein (LDL) particle diameter,     high-sensitivity C-reactive protein) and quality of life.   "
179371|NCT00196118|"     The purpose of this study is to test the hypothesis that the Günther Tulip Vena Cava Filter     can be removed after a period of implantation, when implanted in patients for the prevention     of pulmonary thromboembolism.   "
179357|NCT00195936|"     This study will measure the effect of cinacalcet (Sensipar) on parathyroid hormone (PTH)     secretion in children and adolescents with hypophosphatemic rickets (XLH). The investigators     are seeking evidence that patients with XLH may benefit from treatment with cinacalcet by     achieving better control of PTH secretion.   "
179358|NCT00195949|"     Pyloric stenosis is a condition that develops in infants and that leads to an obstruction of     the channel going out of the stomach. This study is being performed to determine if there is     an advantage to the laparoscopic approach or the open approach for the surgical correction of     the enlarged pylorus.   "
179359|NCT00195962|"     The goal of this study is to identify infants who are at risk for developing problems related     to being breast-fed.   "
179360|NCT00195975|"     The current study is designed to assess relationships between anxiety/stress, autonomic     nervous system balance, and electrical activity in the stomach before and after     eating/drinking in children with abdominal pain.   "
179361|NCT00195988|"     Open label, randomised, prospective, onecentre Investigator Driven Study:      Comparison of two protocols of immunosuppression after liver Tx in children:      A: Study group - FK506-MMF. Immunosupression protocol: Methylprednisolone 10 mg/kg     intraoperatively i.v. FK506 Day 0 or 1 orally (0,15 mg/kg/D in two doses).MMF max. dosage 30     mg/kg/D p.o. day 0 through day 90.      B. Control group - Tacrolimus, steroids. Immunosupression protocol: Methylprednisolone 10     mg/kg bm intraoperatively Children < 25kg bm: Methylprednisolone taper from 100 mg/D on day 0     to MP 10 mg on day 7 Children > 25kg bm: Methylprednisolone taper from 200 mg/D on day 0 to     MP 20 mg on day 7 Week 2-4 Prednisone - 0,5-0,3 mg/kg/D; Week 4-12 Prednisone –0,3-0,2     mg/kg/D; Month 4-6 Prednisone 0,2 – 0,1 mg/kg/D Month 7 – Steroid withdrawal FK506 Day 0 or 1     orally (0,15 mg/kg/D in two doses).      Primary end points:      Number of rejections, number of steroid-resistant rejections.      Secondary end points:      Patients and graft survival Dyslipidemia one year after transplantation Hypertension one year     after transplantation Hyperglycemia/Diabetes de novo one year after transplantation Renal     function before Tx and 1 year after Tx   "
179362|NCT00196001|"     Males and females may exhibit different responses to testing of adrenal function. The     hormones responsible for controlling adrenal function are ACTH (adrenocorticotropic hormone     or corticotropin) and CRH (corticotropin-releasing hormone). Adrenal function is tested with     an ACTH stimulation test. ACTH stimulates the adrenal glands to produce cortisol. Cortisol     levels are measured, and a certain peak level indicates normal adrenal gland function.     Females may produce more cortisol in response to ACTH testing than males. This difference may     be due to certain proteins, called G proteins. The hormones controlling adrenal function,     ACTH and CRH, work through G proteins. Females may have more G proteins than males allowing     for the increased cortisol response to ACTH stimulation.      We speculate that:        1. There may be differences in adrenal responsiveness to ACTH stimulation testing between          healthy males and females.        2. ACTH and CRH induce their own function.        3. Sex differences in adrenal responsiveness to ACTH stimulation testing may be related to          sex differences in G protein expression.      In this study, cortisol, a hormone produced by the adrenal glands, will be measured before     and after the administration of ACTH.      This study will also measure G proteins. G proteins are found in the white blood cells. White     blood cells from females may have more active G proteins than white blood cells from males.     Sex differences may be augmented after exposure to ACTH.   "
179363|NCT00196014|"     The purpose of this study is to validate the psychometrics of the Individual Workload     Perception Scale (IWPS).   "
179364|NCT00196027|"     The primary objective of this study is to demonstrate the safety of the PFX Closure System     when utilized for patients with patent foramen ovale (PFO) suffering from cryptogenic stroke,     transient ischemic attacks or paradoxical embolism.   "
179365|NCT00196040|"     The primary objective of this study is to demonstrate the safety and efficacy of the PFX     Closure System when utilized for patent foramen ovale (PFO) in patients suffering from     cryptogenic stroke (undetermined cause of stroke), transient ischemic attack (brief     neurological dysfunction), migraine or decompression illness.   "
179366|NCT00196053|"     The purpose of this observational registry is to collect a continuum of meaningful clinical     data on the ARCHIMEDES implantable pump in pain management   "
179367|NCT00196066|"     The purpose of this study is to assess the ability of a vascular stent to maintain an open     iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a     long history of use in medical devices. The stent self-expands once inside the artery where     it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow     over the stent helping to hold it in place.   "
179368|NCT00196079|"     The ASPECT study is an Asian multicenter, randomized, controlled, triple-blinded study     designed to evaluate the ability of the Cook Incorporated Paclitaxel Eluting Supra G Coronary     Stent to reduce restenosis in the coronary artery.   "
179369|NCT00196092|"     The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith     Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac     aneurysms.   "
179370|NCT00196105|"     This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol     Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of     palliative treatment of malignant obstructive jaundice.   "
179372|NCT00196131|"     Hypothesis: During severe brain trauma (injury, surgery) the ensuing inflammatory response in     the central nervous system (CNS) results in a decrease in the expression of the transporter     protein p-glycoprotein (PGP) in the blood brain barrier. This loss results in the penetration     into the brain of certain drugs that are normally excluded by the transporter protein. In     this study the working hypothesis is that the agitation observed in patients with CNS trauma     treated with morphine is related to the inflammation evoked loss of PGP in the blood brain     barrier and the accumulation of the morphine metabolite 3-morphine glucuronide.   "
179373|NCT00196144|"     The purpose of this study is to evaluate the effect of individual adjustment of the     postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber     pacemakers.   "
179398|NCT00196469|"     This study is designed to test an incidental finding of a previous trial in which post hoc     analysis showed that the rate of intensive care newborns requiring mechanical ventilation was     lower in the group receiving heparin with the continuous infusion as compared to the placebo     group.   "
179374|NCT00196157|"     In this randomized study dealing with the ablative treatment of persistent atrial     fibrillation, two ablation strategies are compared: a more anatomically guided linear     ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the     electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac     electrograms thought to maintain atrial fibrillation.   "
179375|NCT00196170|"     This randomized study compares two energy sources for the catheter based ablation of typical     isthmus-dependent atrial flutter: The (standard) radiofrequency (RF) ablation technique and     the cryo-ablation technique regarding the acute and long term efficacy and safety.   "
179376|NCT00196183|"     The purpose of this study is to compare two strategies of catheter-based treatment of     paroxysmal atrial fibrillation: Pulmonary vein isolation either alone or combined with     electrogram-guided substrate-ablation.   "
179377|NCT00196196|"     The purpose of this study is to determine the agreement rate between the CODMAN Valve     Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in     order to support an alternative to X-ray confirmation with respect to the valve adjustment     process.   "
179378|NCT00196209|"     The aim of this randomized study is to evaluate the efficacy of two different approaches for     conversion of persistent atrial fibrillation, the non-invasive one (external electrical     cardioversion) and the invasive one (catheter ablation).   "
179379|NCT00196222|"     In this randomized study, two energy sources for the ablation of AV nodal reentry tachycardia     are compared: The standard technique of radiofrequency energy delivery is compared with the     new approach of cryo-energy application.   "
179380|NCT00196235|"     The purpose of this study was to evaluate the performance of established and new risk     predictors in predicting mortality in post-infarction patients suffering from diabetes     mellitus   "
179381|NCT00196248|"     Sudden cardiac arrest is one of the most common causes of death in industrial countries. The     main objective of this study is to built up a register of all out-of hospital resuscitation     in a defined area. According to this register, it is possible to evaluate for example     predictors of survival to improve training and organisation of prehospital resuscitations.   "
179382|NCT00196261|"     The purpose of this study is to investigate the performance of established and new risk     preditors in predicting long term-mortality (up to ten years) of post-infarction patients.   "
179383|NCT00196274|"     The purpose of this study was to develope and evaluate a new method for risk stratification     which predicts high mortality risk in patients with cardiac disease based on simultateous     examination of high resolution ECG, continuous arterial pressure and a breathing signal.   "
179384|NCT00196287|"     The purpose of this study was to investigate differences in risk prediction in female     post-infarction patients.   "
179385|NCT00196300|"     The objective of this study was to determine the prognostic utility of established risk     predictors following acute ST elevation myocardial infarction in patients over 75 years of     age.   "
179386|NCT00196313|"     This study is being conducted to evaluate the effects of treatment with Seasonique an     extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the     typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to     extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9     months. Patients will be required to record menstrual pain in a daily diary.   "
179387|NCT00196326|"     This is an open-label, single treatment study. All subjects will receive one year of oral     contraceptive therapy with DR-1011. Study participants will receive physical and     gynecological exams, including Pap smear. During the study, all participants will be required     to complete a diary.   "
179388|NCT00196339|"     This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used     as add-on therapy for prostate cancer patients with hot flashes following surgical or     medical castration. All prostate cancer therapy must be stable for at least 45 days before     entering the study and must remain stable throughout this 12-week study. Patients will     maintain a daily paper diary to record the frequency and severity of hot flashes during the     treatment period.   "
179389|NCT00196352|"     This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral     contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for     up to an additional three consecutive years.   "
179390|NCT00196365|"     This study is being conducted to evaluate the effects of treatment with Seasonique an     extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the     typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study     duration will be approximately 9 months. Patients will be required to record menstrual pain     in a daily diary.   "
179391|NCT00196378|"     This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to     evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe     symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy     and/or oophorectomy.   "
179392|NCT00196391|"     This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo     and oral micronized progesterone in inducing withdrawal bleeding in women with secondary     amenorrhea.   "
179393|NCT00196404|"     This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two     doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure     urge incontinence, urinary urgency and elevated urinary frequency   "
179395|NCT00196430|"     The purpose of this study is to investigate whether the treatment of acute neurodermitis with     silver-contained textiles is equivalent or more effective to the conservative exogenous     treatment with a corticosteroid. Secondary aim is to define skin comfortability of the     textiles.   "
179396|NCT00196443|"     The purpose of this study is to investigate if wearing of compression stockings influences     the skin moisture. Conservative stockings are compared with urea containing compression     stockings to find out if using urea prevents dehydration of the skin while wearing the urea     compression stockings. Secondary aim was to find out if urea containing stockings increase     the compliance to wear the compression stockings regulary by patients with diagnosed chronic     venous insufficiency.   "
179397|NCT00196456|"     The purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal     patients   "
179400|NCT00196495|"     Pelvic floor prolapse is a general term used to describe various clinical conditions that are     associated with pelvic floor (muscles that support the vagina) relaxation in female     patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing     of the soft tissue structures that support the pelvic organs. These tissues become     compromised because of a weakened or damaged.The purpose of the study will be to demonstrate     the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.   "
179401|NCT00196508|"     This is a randomized controlled trial and multi-centered study with a 2-arm design. The     treatment group will receive topical skin adhesive for skin closure of their wound and the     control will receive sutures. Subjects will be assessed at follow-up visits. Patients are     required to maintain a diary postpartum.   "
179402|NCT00196521|"     Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of     surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with     physical activity, coughing, sneezing, etc.Patients in the study will have an operation to     improve urinary incontinence symptoms. This will involve inserting a mesh sling to help     support the urethra (tube leading into your bladder). During the operation, the study doctor     will use tension-free vaginal obturator system. The study will include women diagnosed with     Stress Urinary Incontinence who have completed their families.   "
179403|NCT00196534|"     The purpose of this study is to see if Human Thrombin is as effective as Bovine Thrombin in     stopping surgical bleeding within 10 minutes of application.   "
179404|NCT00196547|"     The purpose of the study is to determine if Montelukast added to other therapy, if any, will     reduce the severity of asthma symptoms in children during the high incidence of respiratory     viral infections that occur in children in the post Labor Day school return period.   "
179405|NCT00196560|"     The purpose of this study is to determine whether immobilizing the affected shoulder of first     time anterior shoulder dislocation patients in external rotation (vs immobilization in     traditional internal rotation) reduces the rate of recurrent dislocations experienced in 24     months.   "
179406|NCT00196573|"     The purpose of this study is to compare the effectiveness of arthroscopic subacromial     decompression (acromioplasty) to arthroscopic subacromial bursectomy (no acromioplasty) in     rotator cuff impingement syndrome. The investigators' hypothesis is that arthroscopic     subacromial decompression provides no additional benefit, as evaluated with disease specific     quality of life measures, compared to arthroscopic bursectomy.   "
179407|NCT00196586|"     The purpose of this pilot study is to evaluate efficacy and safety of addition of IL-2 to     pegylated interferon alpha 2a and ribavirin in HIV-HCV coinfected patients non-responders     after three months of standard therapy with pegylated interferon alpha 2a and ribavirin. IL-2     may enhance numbers and function of CD4 T lymphocytes and specific anti-HCV immune responses     and could participate to the control of HCV replication   "
179408|NCT00196599|"     In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple     combination with protease inhibitor is recommended. Such therapy induces side effects and the     number of pills may reduce therapy adherence. The aim of this study is to evaluate the     efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with     CD4 cell count over 100/mm3, antiretroviral naive.   "
179409|NCT00196612|"     The combination of two nucleoside analogues and one protease inhibitor is a highly active     antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral     load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side     effects and the same efficacy. The aim of the study was to evaluate if the once daily     combination presents the same efficacy than the HAART therapy with less side effects and a     better adherence.   "
179410|NCT00196625|"     HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side     effects and the great number of pills reduces adherence to the treatment, and induces     therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated.     The aim of the study is to compare the antiviral efficacy of this salvage therapy combining     lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside     reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom     multiple antiretroviral regimens had failed.   "
179411|NCT00196638|"     Treatment of acute primary HIV infection may improve long-term outcome. However, optimal     treatment is still debated. The ANRS 112-INTERPRIM trial evaluates three different     therapeutical strategies, combining permanent or intermittent HAART and a cytokine,     interferon alpha, in order to determine which combination allows the best control of HIV     viremia after 24 weeks of antiretroviral treatment interruption   "
179412|NCT00196651|"     HIV-specific immune responses are preserved in patients treated early during primary     infection.The trial evaluated whether the addition to HAART of IL-2 alone or combined with an     immunization procedure might enhance HIV immune responses and improve viral control after     HAART discontinuation   "
179413|NCT00196664|"     Depression is a common side effect of interferon in the treatment of chronic hepatitis C. The     aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant     agent, in the prevention of depression induced by PEG-interferon given for the treatment of     chronic hepatitis C.   "
179414|NCT00196677|"     The purpose of this study is to determine if certain food additives are effective in the     treatment of glaucoma, improving and reversing the progress of the disease.   "
179415|NCT00196690|"     -  Aphasia (impairment of language function due to brain damage)may be treated with          speech-language therapy and drugs. Several drugs have been studied but with limited          success.        -  Recent data suggest that the neurotransmitter acetylcholine may be reduced in brain          damaged subjects and that drugs that stimulates acetylcholine activity may help recovery          of aphasic deficits particularly when paired with speech-language therapy.        -  Recent evidence indicates that medicaments acting on the neurotransmitter acetylcholine          may promote improvement of aphasic deficits and our previous open-label study of          donepezil in post-stroke aphasia showed benefits in all patients and observed benefit          were long-lasting (6 months).This study will test the safety and efficacy of donepezil          (an agent acting on acetylcholine)in subjects with stroke-related chronic aphasia (more          than 1 yr of evolution).   "
179416|NCT00183703|"     This study will examine how various factors, such as psychiatric symptoms, gender, quality of     life, and attitudes toward medication, affect treatment adherence in individuals with rapid     cycling bipolar disorder.   "
179417|NCT00183716|"     This study will determine the effectiveness of the Trauma Recovery and Empowerment Model in     reducing the severity of post-traumatic stress disorder symptoms in women with mental     disorders and who have experienced sexual or physical abuse.   "
179418|NCT00183729|"     This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes     and preventing major depressive disorder in older adults who have been admitted to a     rehabilitation hospital for a hip fracture or cardiopulmonary condition.   "
179419|NCT00183742|"     This study is for patients with advanced cancer that has failed treatment with conventional     therapy or for which no standard treatment exists. The purpose of this study is to determine     the highest dose that can be given of 2 chemotherapy drugs, docetaxel (also called Taxotere)     and liposomal doxorubicin (also called Doxil), when given together and to determine the side     effects of this combination. Both Taxotere and Doxil are chemotherapy drugs that can decrease     the size of several different tumors. Taxotere is approved by the Food and Drug     Administration (FDA) for the treatment of breast and lung cancers, and Doxil is approved for     the treatment of ovarian cancer.   "
179420|NCT00183755|"     This study will examine brain responses associated with reinforcement and reward tasks in     individuals with major depressive disorder (MDD).   "
179421|NCT00183768|"     This study will evaluate the effectiveness of combining cognitive behavioral therapy (CBT)     and antidepressants in reducing HIV risk behavior and drug relapse rates in depressed     intravenous drug users.   "
179422|NCT00183781|"     This study will evaluate the effectiveness of the Family Intervention: Telephone Tracking     (FITT) program in improving depression, coping, and family functioning in HIV-infected     individuals and their caregivers.   "
179423|NCT00183794|"     This study is for patients with advanced ovarian cancer that has reappeared after treatment     with conventional therapy. The purpose of this study is to determine if the combination of     docetaxel and gemcitabine will be effective in reducing or eliminating the tumor(s) in     patients with ovarian cancer.      Docetaxel is approved by the Food and Drug Administration (FDA) for the treatment of breast     and lung cancer; gemcitabine is approved by the FDA for the treatment of pancreatic and lung     cancer. Neither docetaxel nor gemcitabine are approved for the treatment of ovarian cancer.     Both drugs have been shown to decrease the size of ovarian cancer tumors.   "
179424|NCT00183807|"     This study is for patients with cancer of the esophagus. This study uses the drugs     irinotecan, cisplatin and celecoxib. Irinotecan (also known as CPT-11) was recently approved     by the U.S. Food and Drug Administration (FDA) for use in colon cancer, but has not been     approved by the FDA for use in the treatment of cancers of the esophagus. Cisplatin is a drug     that is commonly used to treat patients with cancer of the esophagus. We are combining these     two chemotherapy drugs with a drug called Celebrex. Celebrex (also called Celecoxib) is an     oral medication that is approved by the FDA for pain in the treatment of arthritis. There is     some information to suggest that this drug may have anti-cancer activity. In prior studies     combining irinotecan and cisplatin, tumors of the esophagus have been shown to shrink. We are     adding Celebrex to these drugs to see if it makes the drugs work better to shrink cancer or     cause fewer side effects.   "
179425|NCT00183820|"     This is a study for patients with advanced testicular cancer. This research study involves     treatment with oxaliplatin, paclitaxel, and gemcitabine, which is an investigational     chemotherapy combination. This study is for patients who have not responded to standard     cisplatin-containing chemotherapy or the cancer has returned after such treatment.      This research is being done to assess the effectiveness of the proposed combination of     medications for this type of cancer.   "
179426|NCT00183833|"     This study is for people with solid tumors cancer for which the standard chemotherapy drugs     have not worked. The purpose of this research is to evaluate the side effects of Xeloda (also     called capecitabine) in combination with a new anticancer agent called Gleevec (also called     imatinib mesylate). Xeloda is an anticancer drug, and can be taken by mouth. The active     ingredient is a well-studied cancer drug called 5-FU. Xeloda is approved by the FDA for the     treatment of colon cancer. Gleevec is approved in the US for the treatment of patients with a     leukemia called CML (increase of white blood cells) after failure of standard therapy. It is     also approved by the FDA for patients with Gastrointestinal Stromal Tumors (a rare tumor in     the digestive tract).      This study will test how much Gleevec we can safely give with Xeloda. Xeloda will be given at     the recommended dose for colorectal cancer and Gleevec will be given in increasing amounts.   "
179449|NCT00184132|"     The purpose of the study is to compare effects of treatment of patients acutely admitted to a     Psychiatric Intensive Care Unit (PICU) with either a sparsely decorated interior or interior     decorations like an ordinary, Norwegian home.   "
179450|NCT00184145|"     The purpose for this study is to determine whether EMDR is effective in the treatment of     specific (animal) phobia.   "
179427|NCT00183846|"     This study is for people with advanced cancer of the digestive tract and cancer that cannot     be completely removed by surgery. Radiation therapy is commonly used in the treatment of     these types of cancer in combination with a chemotherapy drug, called 5-fluorouracil (5-FU).     In this study, doctors will administer the standard dose of radiation therapy in combination     with an investigational chemotherapy drug, called irinotecan. Irinotecan can decrease the     size of tumors and also appears to increase the effectiveness of radiation. The purpose of     this study is to determine the highest dose of irinotecan that can be given safely in     combination with radiation therapy, and to determine the side effects when these two     treatments are given together. Irinotecan is approved by the Food and Drug Administration     (FDA) for the treatment of colon cancer, but is not approved for cancers of the digestive     tract. However, the FDA is allowing its use in this research study.   "
179456|NCT00184223|"     The purpose for this study is to determine whether 2x45 minutes Motivational Interviewing     given during hospital stay to acutely admitted psychiatric patients with substance use     problems, can reduce substance use after discharge.   "
179457|NCT00184236|"     The aim of the present study was to determine the effects of either a multidisciplinary     approach or intensity-controlled interval training on cardiovascular risk factors in     overweight adolescents.   "
179428|NCT00183859|"     This is a research study for patients that have an advanced cancer that is confined mostly to     the abdominal cavity and have failed treatment with conventional therapy, or for which no     standard treatment exists. The purpose of this study is to determine the dose of a     chemotherapy drug (called irinotecan) that can be administered safely into the abdominal     cavity. We also wish to identify the side effects of irinotecan when it is administered     directly into the abdomen. In this study, we will also determine the levels of irinotecan in     the blood and in the abdominal cavity.      Irinotecan is a chemotherapy drug that can decrease the size of several different tumors. It     is approved by the FDA for the treatment of colon cancer. It appears that some other     chemotherapy drugs are more effective and may have less side effects when they are     administered directly into the abdomen.   "
179429|NCT00183872|"     This study is for people with advanced gastric or gastroesophageal cancer. This study is     being done to find out how long it takes tumors to grow after receiving treatment with the     drugs irinotecan (also known as CPT-11) and docetaxel (also known as Taxotere). Irinotecan is     a drug that has been approved by the Food and Drug Administration (FDA). Irinotecan has been     approved for treatment of cancer of the colon and rectum. Docetaxel is another drug approved     by the FDA. Docetaxel is approved for treatment of breast, prostate and lung cancer. However,     the FDA has authorized the use of irinotecan and docetaxel in this study. This study will     evaluate the effects of these drugs on participant's tumors. The side effects of the     combination of irinotecan and docetaxel will also be evaluated. This study will also measure     the levels of certain substances in participant's tumors. These substances, called genes     (which are the cell's blueprint), affect how people's bodies react to the cancer drugs. Genes     will also be measured in participant's blood. The researchers want to see if these substances     can predict response to the study drugs.   "
179430|NCT00183885|"     This study is for people with cancer of the liver that cannot be completely removed by     surgery. This study involves giving the drugs mitomycin-C and cisplatin, into an artery in     the liver. Mitomycin-C is a drug that has been approved by the FDA to treat cancer of the     stomach and pancreas. Mitomycin-C is a drug that causes cancer cells to die and prevents them     from reproducing. Cisplatin is also a drug that has been approved by the FDA. Cisplatin is     approved to treat cancer of the testes, ovaries, lung, esophagus, bladder, head and neck.     Cisplatin is a drug that prevents cancer cells from reproducing. The purpose of this study is     to see how long it takes subjects' tumor(s) to grow after receiving the study drugs. Another     purpose of this study is to look at the side effects of this study therapy and how long     subjects survive after receiving it.      An additional purpose of this study is to see how well we can predict subjects' response to     the study therapy, based on blood and tumor tissue tests. These tests will measure the levels     of genes (the cell's blueprint) in subjects' tumors and blood. These genes affect how     people's bodies react to the cancer drugs.   "
179431|NCT00183898|"     This study is for people with advanced gastric or gastroesophageal cancer. This study is     being done to find out how long it takes tumors to grow after patients take the drugs     capecitabine, oxaliplatin and cetuximab. Capecitabine (also called Xeloda) is a drug that has     been approved by the Food and Drug Administration (FDA). Capecitabine has been approved for     treatment of cancer of the colon and rectum. Oxaliplatin is another drug approved by the FDA.     Oxaliplatin is also approved for treatment of cancer of the colon and rectum. Cetuximab is     also a drug approved by the FDA for the treatment of cancer of the colon and rectum, as well     as cancer of the head and neck. Capecitabine, oxaliplatin and cetuximab are not approved for     gastric or gastroesophageal cancer. They are considered experimental drugs for this study.     The purpose of this study is to see how long it takes patients' tumors to progress when they     are taking oxaliplatin and capecitabine. Another purpose is to see how many tumors respond to     this drug combination. The investigators also want to see how long people live when taking     these drugs. The side effects of this drug combination will also be evaluated. This study     will also measure the levels of certain genes (the cell's blueprint) in tumors. These genes     affect how peoples' bodies react to the cancer drugs. Genes will also be measured in the     blood. The investigators want to see how these genes can predict response to these study     drugs.   "
179432|NCT00183911|"     The purpose of this study is to evaluate the side effects of a new treatment for stomach     cancer which may potentially improve the prognosis of this cancer.      Our principle objective is to improve the results of standard chemotherapy and radiation     after surgery of patients with gastric cancer. The intra-abdominal (intraperitoneal)     administration of floxuridine (FUDR) is a procedure that we have studied and have determined     it is a safe treatment. In this study, we want to evaluate the side effects of this treatment     when it is given after surgery but before standard intravenous chemotherapy and radiation.      Study treatment will start with surgical removal of the part of the stomach with cancer,     together with surrounding tissues and lymph nodes. After surgery, patients will get treatment     with a chemotherapy drug, FUDR, administered directly into the abdomen. This is called     intraperitoneal chemotherapy. After this treatment patients will receive repeated intravenous     injection of two drugs, 5-fluorouracil and leucovorin alone or combined with irradiation of     the abdomen.   "
179451|NCT00184158|"     The researchers want to find out the best treatment for cubital tunnel. The researchers     establish the degree of nerve compression and then the patients are randomised to different     treatment alternatives, ranging from conservative to operative treatments.      The study is performed at 5 different hospitals in Norway.   "
179452|NCT00184171|"     The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic     colitis   "
179433|NCT00183924|"     This study is for patients with prostate cancer that is metastatic, progressive, and     resistant to hormonal manipulation and mitoxantrone chemotherapy.Patients have previously     been treated with surgical removal of the testes or hormone therapy, and subsequently with     chemotherapy that included the drug, mitoxantrone (Novantrone). Patients will have prostate     cancer that has worsened despite these treatments.      We hope to learn whether the combination chemotherapy decreases cancer symptoms and tests,     and to determine how frequently serious side effects occur with acceptable toxicity from the     chemotherapy.   "
179458|NCT00184249|"     The study is a prospective multi-centre study to investigate the effect of a new bipolar     ablation strategy of the left atrium in patients with paroxysmal or permanent atrial     fibrillation over time.   "
179434|NCT00183937|"     This study is for patients who have been treated with surgical removal of the testes or     hormone therapy (Lupron or Zoladex) and whose prostate cancer has worsened despite this     treatment.      PS 341 is a type of drug known as a proteasome inhibitor. By inhibiting the proteasome in     cancer cells, PS-341 alters the way those cells divide). We hope to learn whether this     combination chemotherapy decreases cancer symptoms and tests (prostate specific antigen, also     called PSA), and to determine how frequently serious side effects might occur with this     treatment for this stage of prostate cancer.   "
179435|NCT00183950|"     This study is for patients with non-hodgkin's lymphoma or chronic lymphocytic leukemia, which     has failed to shrink or has returned after previous treatment with chemotherapy. The purpose     of this study is to find out whether patients with these types of cancer will have their     tumor shrunk after treatment with a drug called Noscapine. The second purpose is to see what     are the side effects of this drug. This drug is being used as an over-the-counter cough     suppressor in Europe and Japan, but has also shown to be effective against cancer.   "
179436|NCT00183963|"     The subjects in this trial have been diagnosed as having a pre-cancerous disease of the     breast called ductal carcinoma in situ (DCIS). This condition is associated with the     development of breast cancer in up to 50% of cases.      The subjects are being asked to participate in this research study. They are being offered     voluntary admission to this study to test the effects of a new investigational drug called     Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug     Administration (FDA) for the treatment of advanced breast cancer but has not been approved     for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in     this study. The purpose of this study is to find out if Fulvestrant has any effect on the     subject's precancerous changes by comparing samples taken before and after receiving     Fulvestrant.   "
179437|NCT00183976|"     This study is for patients who have been treated before and either the treatment did not work     or the lymphoma has come back.   "
179438|NCT00183989|"     This study is being done in order to determine the effectiveness of the combination of     fludarabine, mitoxantrone, and rituximab in patients with mantle cell lymphoma. All three     drugs,fludarabine, mitoxantrone, and rituximab have been approved by the U.S. Food and Drug     Administration (FDA)for the treatment of certain types of lymphoma. Rituximab is a drug     (called a monoclonal antibody) which has anti-tumor activity on certain types of lymphoma.     The combination of chemotherapy (fludarabine and mitoxantrone) with rituximab has not yet     been investigated in patients with mantle cell lymphoma and therefore the combination in     investigational.   "
179439|NCT00184002|"     The current standard treatment for non-Hodgkin's lymphoma involves drugs called     cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called     R-CHOP. Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of     people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been     reformulated and been placed in a fatty bubble called a liposome. The reason for placing the     drug in the liposome is that there is evidence that the liposome is better taken up by     tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or     better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved for     ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By     substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be     better at shrinking tumors and with reduced side effects. The purpose of this study is to see     how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone     (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.   "
179440|NCT00184015|"     This research study is for subjects with cancer of the kidney (also known as renal cell     carcinoma) that cannot be treated with surgery. The purpose of this study is to see if the     combination of bevacizumab and bortezomib is safe and tolerable and can help people with     kidney cancer. The investigators would also like to find out what dose of the study drugs can     be used safely and effectively, whether the combination of these two drugs can decrease     cancer symptoms and stop tumor growth, and how frequently serious side effects might occur     with this combination.      The study will be conducted in two phases—Phase 1 and Phase 2. In Phase 1, subjects will be     assigned to a fixed dose of bevacizumab and different strengths of bortezomib given at 2     different schedules. Phase 2 will depend on how subjects tolerate the doses and schedules of     bortezomib in Phase 1.      Bortezomib is a type of drug known as a proteasome inhibitor. By blocking the proteasome     in cancer cells, bortezomib affects the way these cells divide. Bevacizumab is an inhibitor     (blocker) of blood vessel formation. Tumors need blood vessels in order to continue to grow     and bevacizumab is thought to work by preventing new blood vessels from growing.      Bortezomib (also called Velcade or PS-341) has been approved by the US Food and Drug     Administration (FDA) for the treatment of myeloma, but has not been approved for the     treatment of kidney cancer. Bevacizumab (also called Avastin) has been approved by the FDA     for the treatment of colon cancer, but has not been approved for the treatment of kidney     cancer. However, the FDA is permitting the combined use of bortezomib and bevacizumab in this     research study.      The bevacizumab that will be given in this study is not a commercially marketed product.     Although it is expected to be very similar in safety and activity to the commercially     available drug, it is possible that some differences may exist. Because this is not a     commercially marketed drug, bevacizumab can only be administered to subjects enrolled in this     study and may only be administered under the direction of physicians who are investigators in     this study.      Approximately 40-52 subjects will take part in this study.   "
179441|NCT00184028|"     This research study is for subjects with squamous cell cancer of the head and neck which is     not solely treatable with surgery or radiation. This research study involves treatment with     an experimental chemotherapy combination of oxaliplatin and Taxotere. Tha main purpose of     this study is to assess the effectiveness of this combination of medications for this type of     cancer.      Approximately 54 subjects will take part in this study.   "
179453|NCT00184184|"     This is a study of the registration of tobacco, coffee and substance abuse among acutely     admitted psychiatric patients.   "
179454|NCT00184197|"     The purpose of this study is to investigate the effect and side-effects of injections with     botulinum toxin in neck muscles in cervicogenic headache compared to injections with sodium     water.   "
179455|NCT00184210|"     Breast cancer tissue is collected from women undergoing scheduled surgery for breast cancer.     The tissue specimen are analyzed by MR spectroscopy. After MR, the intact tissue specimen can     be analyzed by other methods, such as histopathology.      The MR spectral profiles are compared to clinical findings such as the patients diagnosis,     lymph node status and tumor size.   "
179459|NCT00184262|"     The aim of the study is to determine whether exposure and response prevention (ERP) is more     effective when patients are presented with a behavioral therapy versus cognitive therapy     rationale in the treatment of obsessive-compulsive disorder (OCD).   "
179460|NCT00184275|"     The purpose is to characterize tumour biological markers in brain metastases tissue from     patients with different primary tumour by using ex vivo techniques as high-resolution magic     angle spinning MR spectroscopy and micro array.   "
179442|NCT00184041|"     This study is for patients with recently diagnosed blood cancer, called acute lymphoblastic     leukemia (ALL). The standard treatment for this disease consists of many chemotherapy drugs     that are given in different combinations in several steps. Each step of treatment is called a     cycle. Patients will be treated with the chemotherapy drugs that are routinely used in ALL     and which are given in multiple treatment cycles over several months. All the chemotherapy     drugs that are used in this study have been approved by the Food and Drug Administration     (FDA).      One of the drugs, which is typically given to patients with ALL, is called Asparaginase. It     is given together with the other drugs throughout the different cycles of treatment. This     drug can be derived from several sources. The standard source is called E. coli Asparaginase,     which is associated with a risk of allergic reactions. This drug stays in the body for a very     short period of time; therefore, it has to be injected daily for 9-14 days in a cycle of     treatment.      In this study, a different form of Asparaginase will be used, called PEG-Asparaginase (also     called Oncospar), which remains in the body for about two weeks, therefore, it can be given     only once in a cycle of treatment and still maintains high blood levels of the drug.     PEG-Asparaginase has recently been approved by the FDA to treat ALL. Most of the experience     with the drug has been in children with ALL. In children it was found to be as safe as the     standard form of Asparaginase and with less allergic reaction. It was also found to have the     same effectiveness on ALL. The experience with this drug in adults has been more limited.      The purpose of the study is to find out what side effects occur in adults when     PEG-Asparaginase is given with other chemotherapy drugs and to see what effect it has on the     response to treatment of ALL. Another purpose is to find out if the allergic reactions are     reduced with PEG-Asparaginase. In children there is some early information that     PEG-Asparaginase produces fewer antibodies than E.coli Asparaginase. Therefore, another     purpose of the study is to see how many adult patients who receive PEG-Asparaginase develop     antibodies against the drug.   "
179443|NCT00184054|"     This clinical research study is for patients with acute myelogenous leukemia (in short AML)     that did not respond to previous treatment or unable to receive chemotherapy.      Arsenic has been used as a drug for many centuries. While arsenic containing drugs were used     in the past for cancer treatments, the major use of arsenic in western countries has been for     the treatment of uncommon tropical illnesses, such as sleeping sickness. Recently, some new     information suggests that arsenic in a form called arsenic trioxide may also be useful to     treat some cancers of the blood, such as leukemia, lymphoma and myeloma. Studies from China     and the USA showed that patients with a type of blood cancer called acute promyelocytic     leukemia, whose disease failed to respond to other treatments, responded very well to arsenic     trioxide. Studies done in laboratories in the United States have shown that arsenic can kill     AML cells growing in culture dishes.      Ascorbic acid (vitamin C), a natural supplement in our diet, has long been involved with     cancer prevention. Laboratory tests have shown that although arsenic trioxide by itself can     kill AML cells in the test tube, when vitamin C is added to arsenic trioxide in a test tube,     the death of the leukemia cells increases significantly.      The purpose of this study is to find out if the combination of arsenic trioxide (Trisenox)     and ascorbic acid is effective in the treatment of patients who have AML. The second purpose     is to study how the two drugs affect cells in the laboratory. Samples from the blood and bone     marrow (the part of the body that makes blood cells) will be collected, at specific times     during treatment, in order to study them in the laboratory. By studying blood and marrow     cells, researchers hope to learn the mechanisms by which the drugs work.   "
179444|NCT00184067|"     This is a study of a melanoma vaccine. Study participants will have melanoma that invaded     deeply and spread to lymph nodes or another location. Although the participants' melanoma has     been removed, there is a greater than 1 out of 2 chance it will return. There will be     approximately 40 subjects in this study. The patients will have already taken part in a     melanoma vaccine study, and in this current study, they will continue to receive booster     injections of a similar vaccine given for two additional years.      This study will test an experimental vaccine. The vaccine contains peptides which are     fragments of substances made by most melanomas. The substances are tyrosinase, gpl00 and     melanoma antigen recognized by T cells (MART-1). The vaccine also includes an assistant     called Montanide ISA 51. The assistant stimulates the immune system. This study will also     test the effects of a second assistant granulocyte-macrophage colony-stimulating factor     (GM-CSF). All participants will receive the vaccine and assistant Montanide ISA 51, but only     half will receive the assistant GM-CSF. The patients have a one in two chance of receiving     the assistant called GM-CSF. The main purpose of this study is to find out if the booster     injections increase the body's immunity to melanoma and prevent its level of immunity from     getting lower over time. The investigators also wish to know if the GM-CSF increases the     body's immunity to melanoma when given with the melanoma vaccine.      The vaccine and assistant Montanide ISA 51 are not approved by the Food and Drug     Administration (FDA). The assistant GM-CSF is approved by the FDA to increase     infection-fighting white blood cells after chemotherapy. It is not approved by the FDA for     treatment of melanoma. However, the FDA is permitting the vaccine and the assistants to be     tested in this study.   "
179445|NCT00184080|"     The purpose of this study is to evaluate the safety of an experimental drug called     Elsamitrucin in people with non-Hodgkin's lymphoma and to see if it can shrink their tumors.     Elsamitrucin has not been approved by the Food and Drug Administration (FDA). However, the     FDA is permitting the use of this drug for this study.   "
179446|NCT00184093|"     The purpose of this study is first to establish what is the ideal dose of gemcitabine, a     chemotherapy agent, when given in combination with radiation. In addition, the investigators     want to determine the side effects and the effectiveness of this combination. The     investigators will also study several markers to try to identify markers or tests that will     predict which patients will benefit more from this treatment.   "
179447|NCT00184106|"     We aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their     combination, (2) investigate the patterns of change and the mechanisms of action involved     during treatment by using psycho-physiological assessments in order to delineate some of the     cognitive, behavioural and physiological mechanisms in the patients' response to CT, to     paroxetine and placebo.One hundred patients with a primary diagnosis of social phobia will be     selected and randomised into four treatment conditions. The first group (N=25) will be     treated with CT alone, the second group (N=25) with CT plus paroxetine, the third group     (N=25) with paroxetine and clinical management (TAU), the fourth group will receive placebo     and clinical management (N=25). All patients will have 12 weeks of treatment in the acute     phase, which includes 12 sessions of individual treatment for the two first groups. The 2nd     and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase. The     4th group will have placebo for 24 weeks and clinical management. The patients will be     assessed at pre-treatment, at 12 weeks and at the end of treatment of the acute phase (12     weeks) and by the end of maintenance phase (24 weeks). Follow-up will be at 6 and 12 months.      Measures are based on all three main sources; self-report inventories, clinical assessments     by independent raters and psycho-physiological assessments.   "
179448|NCT00184119|"     The purpose of the study is to compare the effects of using or not using a Psychiatric     Intensive Care Unit (PICU) in an acute psychiatric department.   "
179461|NCT00184288|"     The aim of the study is to investigate the feasibility of in vivo single volume MR     spectroscopy in evaluation of treatment response in patients with brain metastases, using 3T     MR instrument. In order to optimize and avoid ineffective treatment of patients with brain     metastases, in vivo MR spectroscopy can be an useful tool.   "
179462|NCT00184301|"     The aim of this study is to determine whether in-patient treatment is better then intensive     out-patient group treatment for patients with concurrent eating disorder and personality     disorder.   "
179463|NCT00184314|"     Retrospective follow-up study of former eating disorder patients in child- and adolescent     psychiatry on psychiatric symptoms and social intelligence.   "
179464|NCT00184327|"     Children receiving IFT (intensive family therapy) were assessed for symptom profile and     global functioning before admission, 3 months after discharge and 1 year after discharge.     Children were assessed by parents, children, their teachers and themselves. Parents were     assessed by themselves at the same points in time through psychological self-report     questionnaires.      The study is intended to explore covariates to change in children as well as in parents     during (pre-treatment) the treatment and follow-up periods.   "
179465|NCT00184340|"     This is the second phase (Phase B) of the main project Bank for Thoughts, which has the     following aims:        1. Improvement of software for secured (encrypted and access-controlled) asynchronous          text-based communication within health services. (Adjustments for use in psychiatry.)        2. Open clinical trials with Internet-mediated psychotherapy or counselling in out-patient          child and adolescent psychiatry.        3. Development of indications and precautions for text-based Internet-mediated          psychotherapy.   "
179466|NCT00184353|"     Increasing magnetic field is known to give improvements in signal-to-noise-ratio (SNR) and     spectral resolution. To investigate this, spectra from different subjects were examined using     two clinical MR instruments operating at 1.5T and 3T respectively.   "
179467|NCT00184366|"     The main objectives of the project are:        -  To classify patients suffering from plaque psoriasis responding on a given treatment          (efalizumab) based upon reduction in Psoriasis Area and severity Index (PASI), Psoriasis          Disability Index 8PDI) and dermatology Life Quality Index 8 DLQI)        -  To characterize patients suffering from plaque psoriasis responding to or not responding          to subcutaneous administrated efalizumab.   "
179468|NCT00184379|"     The purpose of this study is to determine the effects of psychoeducation for relatives to     patients with serious mental illness.   "
179469|NCT00184392|"     The goal of this study is to increase knowledge about how to treat patients after sinus     surgery.   "
179470|NCT00184405|"     This is a study evaluating changes in quality of life and global functioning across and after     a manualized peer-group preventive intervention for children of parents with psychiatric or     addictive problems.   "
179471|NCT00184418|"     The study is based on a hypothesis that there is interaction between the activity in the     immune system and in the mind. To study this, the investigators register different measures     for activity in the immune system on patients unselectedly admitted to an acute psychiatric     ward. The psychiatric statuses and diagnoses of these patients are carefully defined as well.   "
179472|NCT00184431|"     The aim of this study is to investigate whether additional task specific physiotherapy     treatment and a self administrated home training program results in better balance compared     to traditional follow up care.   "
179473|NCT00184444|"     The study investigates whether endurance training breathing 100% oxygen gives a additional     improvement of maximal oxygen uptake in stable Angina Pectoris patients, compared to training     without extra oxygen supplementation. In addition work economy, stroke volume and cardiac     perfusion is measured.      The hypothesis of the study is that increased oxygenation of the air increases performance,     stroke volume, work economy and cardiac perfusion.   "
179474|NCT00184457|"     Maximal strength training has been shown to increase muscular strength, muscular volume and     work economy. An 8 week maximal leg press training regime will be conducted on cardiac heart     failure patients to evaluate whether they increase their maximal leg press strength, work     economy, serum testosterone and quality of life. The study hypotheses are that:        1. Aerobic work capacity will increase due to increased work economy, without increases in          maximal oxygen uptake.        2. Strength training will increase serum testosterone.   "
179475|NCT00184470|"     St. Olavs Hospital is a trauma referral center in the region of Midtnorge. Admitting trauma     patients locally and those referred from hospitals in Nord-Trøndelag, Sør-Trøndelag and     Møre-Romsdal.An active trauma team was defined in 1992, but it`s work has not been evaluated     earlier. Prospective studies of these patients were established 1st of January 2004 at St.     Olavs Hospital.   "
179476|NCT00184483|"     Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation     or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total     number of 4 clinical examinations. End point is postoperative pain and recurrences.   "
179477|NCT00184496|"     Cancer patients on morphine for chronic pain, with side effects or unsatisfactory pain     relief, will be rotated to Methadone. We will try to find out what is the best methode to     rotate, and the equivalent dosage.   "
179480|NCT00184535|"     Delayed anticipatory muscle activity response in deep low back and abdominal muscles has been     observed in patients with low back pain, indicative of a pathological condition. Muscle     activity onset is traditionally recorded by intramuscular electromyography, but there is a     need for a less cumbersome recording method in large clinical studies. The purpose of this     experimental study is to explore whether high-frame rate m-mode ultrasound and tissue     velocity imaging could measure anticipatory muscle responses (onset) in the abdominal     muscles reliably and comparably accurate to intramuscular EMG.   "
179481|NCT00184548|"     This trial is conducted globally. The purpose of the trial is to evaluate that activated     recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely     injured trauma patients by assessing mortality and morbidity.      Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.   "
179482|NCT00184561|"     This trial is conducted in Asia. This is a clinical trial investigating the effectiveness of     using Biphasic Insulin Aspart 70/30 in two different treatment regiments for 6 months in     subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug     therapy.   "
179483|NCT00184574|"     This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic     control in subjects with type 2 diabetes of three different premixed insulin analogues given     in combination with an oral anti-diabetic drug.   "
179484|NCT00184587|"     The purpose of this study is to determine whether candesartan cilexetil are effective     prophylactic treatment of episodic Cluster headache   "
179485|NCT00184600|"     This trial is conducted in Europe.      The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood     glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added     to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to     verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and     side effects).   "
179486|NCT00184613|"     This trial is conducted in Europe. The objective of the study is to investigate the effect     and safety of continously basal delivered insulin aspart given by a pump versus once daily     injection of insulin glargine.   "
179487|NCT00184626|"     This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of     Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in     combination with metformin in subjects with Type 2 Diabetes.   "
179488|NCT00184639|"     This trial is conducted in Europe.      A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in     children between 6 and 21 years with type 1 diabetes.   "
179489|NCT00184652|"     This trial is conducted in Asia, Europe, and Middle East. Adult patients with chronic kidney     disease are treated with growth hormone to assess effect on nutritional status.   "
179490|NCT00184665|"     This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this     research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of     insulin detemir compared to NPH insulin administered as basal insulin for the treatment of     type 1 diabetes and to verify the safety of use (number and severity of episodes of     hypoglycemia, body weight, and insulin antibodies and side effects).   "
179491|NCT00184678|"     This trial is conducted in Europe. Growth Hormone in young adults with growth hormone     deficiency in childhood. This trial compares a treated group of patients with an untreated     group of patients.   "
179492|NCT00184691|"     This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and     tolerance of a new growth hormone (GH) formulation, in the treatment of children born with     retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be     multicenter, open label, parallel, randomized, Phase IIIb, controlled.   "
179493|NCT00184717|"     This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety     of somatropin in children born small for gestational age (SGA) in Japan.      In the main period, subjects will receive either active treatment for 104 weeks (two dosing     regimens) or no treatment for 52 weeks followed by an extension period where subjects who     received active treatment for 104 weeks (two years) will continue with the same treatment for     further 156 weeks (three years) while those subjects who received no treatment for 52 weeks     (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In     total, subjects participate in trial for 260 weeks (five years).      Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension     period is registered as GHLIQUID-1517.   "
179494|NCT00184730|"     This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to     subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519)     until hGH products have been approved for GHDA in Japan.   "
179495|NCT00184743|"     This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change     in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth     Hormone Deficiency, comparing two different treatment regiments.   "
179496|NCT00184756|"     This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial     compares a treated group of patients with an untreated group of patients.   "
179497|NCT00184769|"     This trial is conducted in Europe. Objective(s): To evaluate the effect of human growth     hormone on infants aged 1 to 2 years with chronic renal insufficiency (CRI) and growth     retardation despite an adequate dietary intake.      Trial Design: This is an open, parallel group clinical trial with a duration of one year, in     which period 50% of patients will receive GH treatment and the other 50% will act as a     control group, without treatment.      Trial Population: The trial will involve a total of 16 infants aged from 12±3 to 24 months     suffering chronic renal insufficiency (Glomerular Filtration Rate less than 60 ml/min/1.73     m2), and growth failure and undergoing conservative treatment or peritoneal dialysis. Include     the key inclusion and exclusion criteria.   "
179498|NCT00184782|"     The purpose of this study is to evaluate the effect of primary tumor resection on the     metabolic activity of metastases in patients with a colorectal primary tumor and synchronous     liver metastases by positron emission tomography (PET) with 2-deoxy-2-fluoro[18F]-D-glucose     (FDG-PET) scanning.   "
179613|NCT00187473|"     The Major goals of this project was to assess the natural history of disease in chronic     hepatitis C patients with normal ALT and to determine the virologic and host factors     associated with disease severity.   "
179499|NCT00184795|"     This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes     have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone     replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and     safety of different hormonal combinations will be evaluated and compared to placebo over the     six month treatment period.   "
179500|NCT00184808|"     Patients with Parkinson's disease (PD) suffer from motor fluctuations and levodopa induced     dyskinesia. The prupose of this study is to evaluate the effect of an automatic system to     assess the motor state of PD patients in real daily life. Movements and postures are assessed     using 6 accelerometers attached to the the most affected wrist, trunk, both upper legs and     both upper arms. Patients wear the system for two days and keep an own diary of their motor     state   "
179509|NCT00184925|"     The purpose of this study is to investigate the incidence of ventilator associated pneumonia     and late complications by comparing two different cannulas and two different percutaneous     tracheostomy techniques.   "
179501|NCT00184821|"     In this proof-of-concept study, forearm vulnerability to ischemic exercise is studied in     patients with type 1 diabetes mellitus with and without prior ischemic preconditioning (short     period of ischemia that protects against subsequent ischemic exercise). Annexin A5     scintigraphy is used to quantify subtle signs of mild and reversible forearm injury that     results from ischemic exercise.      The following hypotheses are tested:        1. Patients with type 1 diabetes are not more vulnerable to ischemic injury as compared          with previously studied healthy volunteers.        2. Ischemic preconidtioning is still present in patients with type 1 diabetes. Depending on          the validity of hypothesis 2, the effect of short pharmacological interventions are          studied on vulnerability to forearm ischemia/reperfusion injury in the absence or          presence of local forearm ischemic preconditioning.   "
179502|NCT00184834|"     An increasing aggressiveness in the surgical approach of colorectal liver metastases is     observed. This seems only justified when, besides prolongation of survival, also the health     status of patients is considered. The aim of this prospective study is to investigate the     impact of surgery on health-related quality of life in this specific patient population     operated for colorectal liver metastases.Furthermore, as the indications for hepatic     resection are broadened and patients with more extensive liver disease are operated on, the     chance of non operable disease at laparotomy will increase. The effects of such an event on     HRQol are also studied.   "
179503|NCT00184847|"     Ischemic preconditioning is defined as the development of tolerance to ischemia-reperfusion     injury by a previous short bout of ischemia resulting in a marked reduction in infarct size.     This mechanism can be mimicked by several pharmacological substances such as acetylcholine     and adenosine.      To detect ischemia-reperfusion injury in humans in vivo Kharbanda et al. developed a method     in which endothelial dysfunction represents the effects of ischemic preconditioning. This     method, however, uses acetylcholine to measure endothelial function before and after forearm     ischemia. We, the investigators at Radboud University, hypothesize that the use of     acetylcholine in this model reduces ischemia-reperfusion injury. Therefore, we will compare     this protocol with a protocol in which endothelial function is only measured after ischemia.     We expect an increase in ischemia-reperfusion injury when endothelial function is only     measured after the forearm ischemia.      After determining the optimal method to measure ischemia-reperfusion injury of the vascular     endothelium we will determine the effect of acute and chronic caffeine, an adenosine receptor     antagonist, on ischemic preconditioning. With this study we expect to find that adenosine     mimics ischemic preconditioning of the vascular endothelium. Moreover, we expect to find that     acute caffeine intake reduces ischemia-reperfusion injury whereas chronic caffeine intake     does not. This study will increase our knowledge about the mechanism of ischemic     preconditioning and may also provide leads to exploit this endogenous protective mechanism in     a clinical setting.   "
179504|NCT00184860|"     Technical developments in radiation oncology are making it possible to deliver a prescribed     radiation dose to radiation target volume with increasing accuracy.      Therefore it is becoming even more relevant to accurately define the radiation target     volumes.      The current standard in defining radiation target volumes in patients with head-and-neck     cancer is to combine physical examination data with a CT-scan in the treatment position.      The goal of this investigation is to analyse the rol of CT-PET-MRI image fusion in defining     radiation target volumes.   "
179505|NCT00184873|"     Leg ulcers are often chronic or recurring complications of peripheral circulation disorders.     Patients' lifestyles are known to influence leg ulcer occurrence and circulation disorders in     general. Especially exercise and compliance with compression therapy are key elements in the     course of leg ulcer healing and recurrence. Yet many patients demonstrate sedentary     lifestyles and non-compliance and current practice offers no systematic approach in the     promotion of compliance and physical activity in these patients.      The purpose of the study is testing 'Lively Legs' a compliance promotion program for patients     with leg ulcers. The study tests the program on effects regarding:        -  compliance with compression therapy and exercise levels        -  time to leg ulcer recurrence        -  cost effectiveness from a social perspective.   "
179506|NCT00184886|"     In this study we aim to determine whether methotrexate influences the metabolism and vascular     effects of adenosine in humans in vivo. Adenosine is an endogenous purine-nucleoside with     potent anti-inflammatory effects. Also, adenosine receptor stimulation induces vasodilation,     ischaemic preconditioning and many other cardiovacular effects. Previous animal studies have     provided limited evidence that the anti-inflammatory effects of methotrexate are mediated by     adenosine receptor stimulation. In this study, we aim to determine whether also in humans in     vivo, methotretate influences endogenous adenosine. Therefore, 10 patients with inflammatory     arthritis are treated with methotretxae (15 mg/week orally) for 12 weeks. Before and after     treatment, vasodilation to the infusion of adenosine and dipyridamole into the brachial     artery is assessed as biomarker for the endogenous adenosine concentration.      Also, blood is drawn for the determination of CRP, ESR, Adenosine deaminase activity adn     homocysteine.   "
179507|NCT00184899|"     The metabolic syndrome is associated with hyperdynamic circulation and sympathetic     activation. Recently, Bakker et al. (Atherosclerosis 2002) described the hypothesis that free     fatty acids are responsible for this association. The investigators hypothesize that in     patients with obesity and the metabolic syndrome, an increased intracellular concentration of     long-chain fatty acyl (LCFA)-CoA (the intracellular equivalent of free fatty acids) induces     an increase in adenosine. Adenosine receptor stimulation, in turn, induces vasodilation and     sympathetic activation.      The investigators aimed to assess this effect of free fatty acids on the adenosine system in     healthy volunteers.   "
179508|NCT00184912|"     Ischaemic preconditioning (IP) describes the phenomenon that brief periods of ischaemia     render the (myocardial) muscle more resistant to a subsequent more prolonged period of     ischaemia and reperfusion. Animal studies have provided evidence that adenosine receptor     stimulation is an important mediator of IP. As caffeine is an effective adenosine receptor     antagonist already at concentrations reached after regular coffee consumption, we aimed to     assess whether caffeine impairs IP in humans in vivo. We used a novel and well-validated     model to study IP in humans: 99m-Tc-annexin A5 scintigraphy in forearm skeletal muscle.      24 healthy volunteers were randomly assigned to either caffeine (4 mg/kg/iv in 10 minutes) or     saline before a protocol for IP.   "
179528|NCT00186355|"     To evaluate the role of purging the hematopoietic cell graft on outcomes for non-Hodgkin's     Lymphoma.   "
179510|NCT00184938|"     The most powerful protective mechanism against ischemia-reperfusion injury other than rapid     reperfusion is ischemic preconditioning. Ischemic preconditioning is defined as the     development of tolerance to ischemia-reperfusion injury by a previous short bout of ischemia     resulting in a marked reduction in infarct size. This mechanism can be mimicked by several     pharmacological substances such as adenosine and morphine.      We, the researchers at Radboud University Nijmegen Medical Centre, have recently developed a     method in which we can detect ischemia-reperfusion injury in the human forearm by using     Annexin A5 scintigraphy (Rongen et al). With this method we will determine whether opioid     receptors are involved in ischemic preconditioning. We expect to find that morphine can mimic     ischemic preconditioning and that acute ischemic preconditioning can be blocked with the     opioid receptor antagonist naloxon. This study will increase our knowledge about the     mechanism of ischemic preconditioning and may also provide leads to exploit this endogenous     protective mechanism in a clinical setting.   "
179511|NCT00184951|"     open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with     hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.   "
179512|NCT00184964|"     CT-PET image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better     than the CT-scan in patients with non-small cell lung cancer who also have atelectasis.      This however has never been validated on a histological level. In this study patients with     non small cell lung cancer and atelectasis who are eligible for surgery undergo a CT-scan and     a PET-scan prior to surgery.      The resection specimen will be compared to the preoperative imaging.   "
179513|NCT00184977|"     The aim of this family practice based study is to determine the long-term treatment effects     of two drugs that are presumed to modify the course and progression of chronic obstructive     pulmonary disease (COPD), oral N-acetylcysteine and inhaled corticosteroids.   "
179514|NCT00184990|"     Sepsis or endotoxemia is manifested by hypotension, resistance to vasopressors, myocardial     depression,and altered organ blood flow distribution. The mechanisms underlying the     cardiovascular dysfunction during sepsis are complex; however, they are partially mediated by     an uncontrolled production of NO by inducible NO synthase (iNOS).Control subjects received 2     ng/kg E. coli endotoxin, whereas the active intervention group received endotoxin in the     presence of selective iNOS-inhibitor aminoguanidine. Hemodynamics, vascular responses to     norepinephrine, acetylcholine and sodium nitroprusside, as well as circulating cytokines and     other mediators of inflammation were measured. We tested the hypothesis that inhibition of     NO-synthesis prevented the LPS-mediated insensitivity to noradrenalin and     endothelial-dependent vasorelaxation. Furthermore, we tested whether NO participates in     occurrence of the endotoxin tolerance in humans by using the iNOS inhibitor aminoguanidine on     healthy volunteers with endotoxemia. At 0; 2 and 4 hours after the LPS challenge whole blood     was stimulated with five TLR agonists in vitro and pro- and anti-inflammatory cytokines were     measured.   "
179515|NCT00185003|"     Background: Activation of NO-synthase and vascular potassium (K) channels may play a role in     the sepsis-induced attenuated sensitivity to norepinephrine. We examined whether various K     channel blockers and NO-synthase inhibition could restore norepinephrine sensitivity during     experimental human endotoxemia.   "
179516|NCT00185016|"     The study tested a training to improve recognition of abused female patients in family     practice.Effect measures of the training were: number of reported cases wherein the doctor     suspected and discussed partner abuse and the number of non-obviuos reasons to suspect     partner abuse.We assumed that following a training would improve the recognition of abused     women.      Secondary to this trial we explored gender differences of family doctors in discussing     partner abuse and we interviewed women recently identified by their family doctor. Medical     histories of recently identified abused women were studied to assess health problems and     health-care utilisation.   "
179517|NCT00185029|"     This proposal is targeted at all patients with prostate cancer who are candidates for either     curative surgery or curative radiotherapy in whom lymph node staging is indicated. Recently,     it has been shown, that in patients with PSA <10 ng/ml and Gleason score < 7 the risk of     lymph node metastases is low. Therefore, unnecessary PLND and non-invasive imaging can be     avoided safely in this group. PLND is nowadays performed only in patients with intermediate     or high risk for nodal metastases. Thus the subgroup of patients targeted in this study     consists of patients with prostate cancer with a PSA >10 ng/ml and Gleason score > 6.        -  If the high sensitivity (90%) and negative predictive value (96%) of MRL can be          validated in the 8 participating centres, in patients with a negative MRL invasive PLND          may be avoided.        -  In patients with a positive MRL with enlarged nodes (larger than 8 mm) histological          diagnosis may be obtained by imaged guided biopsy, and thus also in these patients avoid          PLND. A limitation of image guide biopsy, however, is the 30% false negative rate.          [Barentsz, Oyen, Wolf]        -  In patients with positive small nodes (smaller than 8 mm) the urologist may, focussed by          the MRL findings of a positive node outside his “surgical field-of-view”, extend his          dissection, and thus improve his accuracy.        -  Based on the expected higher sensitivity of MRL this technique will completely replace          CT-scanning.   "
179518|NCT00185042|"     The purpose of this study is to learn if CS-505 is safe and effective for slowing down or     possibly reversing the buildup of tissue, cells and fatty deposits (plaque) in the blood     vessels of the heart (coronary artery atherosclerosis).   "
179519|NCT00185055|"     To assess the effects of 3 blood pressure drugs, called angiotensin receptor blockers, on the     blood pressure control systems in healthy subjects.   "
179525|NCT00186316|"     Patients with Multiple myeloma who have undergone non-myeloablative allogeneic stem cell     transplant will receive 6 vaccinations of donor derived dendritic cells combined with     specific protein produced by multiple myeloma.   "
179526|NCT00186329|"     Many patients with exacerbations of heart failure have significant concomitant kidney     dysfunction. The combination of these two conditions makes pharmacological management     difficult. In this study, we plan to randomize patients with heart failure and kidney     dysfunction to receive infusions of Natrecor (B-type Natriuretic Peptide)--which may be     beneficial to the management of these two diseases--or placebo.   "
179527|NCT00186342|"     The purpose of this study is to determine the tolerability and efficacy in treating patients     aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or     myeloproliferative disorders (MPD).   "
179534|NCT00186433|"     1. To determine the prognostic implication of plasma Epstein-Bar Virus (EBV) DNA          concentrations, as measured by quantitative polymerase chain reaction (PCR) in patients          with nasopharyngeal carcinoma (NPC).        2. To relate pretreatment plasma EBV DNA concentration to WHO classification of these          tumors both in endemic and non-endemic areas.        3. To determine whether pretreatment plasma EBV DNA can serve as a prognostic factor for          both endemic and non-endemic patient populations.   "
179535|NCT00186446|"     The purpose of this study is to assess the safety and feasibility of concurrent treatment of     nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV     criteria for both nicotine dependence and acute major depression will be given     pharmacological treatment for both disorders at the same time, along with a brief behavioral     intervention for smoking cessation.   "
179536|NCT00186459|"     The goal of the study is to define the roles played by resistance to insulin-mediated glucose     disposal (insulin resistance) and circulating plasma insulin concentrations in: 1) ability to     lose weight; 2) reduction of risk for coronary heart disease as a result of weight loss. We     hypothesize that in the setting of caloric restriction, manipulating endogenous insulin     concentrations will not alter ability of subjects to lose weight, but will lead to different     reduction in CHD risk factors. To test this hypothesis, two parallel studs will be performed.     First, obese insulin-resistant individuals will be randomized to one of two     equally-hypocaloric diets that vary moderately in proportion of carbohydrate and     mono/polyunsaturated fats (lower carbohydrate diet will be associated with greater reduction     in endogenous insulin secretion). Second, diabetics treated with insulin secretagogues will     be compared to diabetics treated with insulin sensitizers with respect to the same outcomes     (secretagogues increase insulin secretion and insulin sensitizers decrease insulin     concentrations). Endpoints include weight loss, change in insulin resistance, blood pressure,     lipid and lipoproteins, markers of endothelial function, daylong insulin and glucose     concentrations: these will be compared, in each of the parallel studies, between the group     with insulin-stimulating intervention vs the group with the insulin-sparing intervention.   "
179537|NCT00186472|"     Infants born premature face numerous medical problems, causing significant anxiety for their     parents. Parents experience a range of negative emotions including concern for the health and     well being of their fragile infant, guilt, and disappointment. Research has indicated that     having an infant in the Neonatal Intensive Care Unit (NICU) is highly stressful for parents     and multiple studies have demonstrated that parents can develop significant psychological     reactions to this experience. Specifically, many parents develop clinically significant     anxiety disorders such as acute stress disorder (ASD) and posttraumatic stress disorder     (PTSD). This not only impacts the mental well-being of the parents, but also can lead to     problems with the parent-infant relationship, and, in turn, negatively impact the infant and     the family as a whole. Despite the reported negative effects parents experience due to the     stress of having an infant on the NICU, surprisingly little research has examined how to     reduce parents' symptoms of anxiety. Because parents play an essential role in the care of     their infant after discharge from the NICU, treating the parent's emotional distress is     highly important. The purpose of this study is to examine the efficacy of a     cognitive-behaviorally based intervention in reducing parents' symptoms of anxiety associated     with having an infant on the NICU. This treatment is modeled after treatments that have     proven effective with parents of children with other types of medical problems, for example,     parents of children with cancer. It is the hope of the investigators that this intervention     will effectively reduce symptoms of anxiety of NICU parents as well as the likelihood of     developing subsequent psychological disorders.   "
179538|NCT00186485|"     We hope to learn whether this stimulation of neurons in the front part of the brain may     relieve depression.   "
179539|NCT00186498|"     The purpose of this study is to determine whether taking the medication memantine reduces     impairment of memory and attention associated with electroconvulsive therapy.   "
179540|NCT00186511|"     The major goal of this project is to test the feasibility and acceptability of using     videoconferencing to provide support groups led by trained facilitators to rural women with     breast cancer in northern California.   "
179541|NCT00186524|"     Women with primary breast cancer may benefit from participating in supports groups as they     cope with treatment and the psychological challenges of survivorship. Studies have documented     that these women benefit from support groups run in a university setting; however, no one has     documented that they benefit from community cancer support groups. Many community cancer     support groups exist and provide service to a large number of women with breast cancer. It is     important to know if these groups are providing comparable service to well researched support     groups. We conducted this study as the first randomized study of community compared to     university-style support groups. Women had a 50/50 chance of being assigned to either a     community or a university style support group based on a coin flip. This study took place in     two sites The Wellness Community East Bay (Walnut Creek) and San Francisco. Two community     groups were studied.      i) This study evaluated the strengths and weaknesses of two community-based support group     interventions for breast cancer patients [The Wellness (TWC) and Cancer Support (CSC)     Communities, in the San Francisco area]. We compared them with a type of therapy developed in     the university setting (Stanford's Supportive-Expressive group therapy), studied which     aspects are most effective, and who benefits the most. We compared these women on change in     emotional distress, means of coping with cancer, and social and family support. In addition,     change in physiological response to stress was measured using saliva samples.      ii) We were able to achieve recruitment for 6 of 8 groups proposed. We randomized 72 women in     blocks of 12 taking consecutive women per site until we accrued 12 for each group. Of those,     61 women actually attended groups, of those 46 women to date completed at least one follow-up     and were available for analysis for this report. We screened 108 women, 16 who were screened     out on initial phone contact, 20 women began to go through our baseline interviews and     assessments and either decided not to enroll or dropped out before we could compose a group     for the second S.F. randomization. Our final two follow-up assessments for our final group in     the East Bay are being conducted right now (8 month) and will be conducted in October, 2002     (12 month) so they are not available for assay or analysis for this final report.      iii) We examined 5 outcome variables for this report and found that women participating in     the community groups changed at about the same level over the 4 months of group therapy as     the women in the Stanford groups. This was true for depression symptoms, trauma symptoms,     social support, self-efficacy, and post-traumatic-growth. These analyses are preliminary     until we complete our final follow-up assessments. It is encouraging for the community groups     that women benefited at the same rate as they did in the well-researched Stanford groups.     Conclusions for this study are somewhat limited because we could not complete the recruitment     of our entire sample. However, there is every reason to suppose that community groups are as     effective at serving women with primary breast cancer as Stanford's groups though they are     based on very different ideas of therapy. It is important to note that all of these groups     were led by therapists, and that we may have found other results if the groups had been led     by peers or other types of professionals. This study reduces the human and economic cost of     breast cancer in California by validating community groups usually offered free to women with     breast cancer.   "
179574|NCT00186966|"     This is an international multicenter open label randomized phase III trial in children with     relapsed and refractory acute myeloid leukemia (AML) such a disease. The main purpose of this     study is to determine the efficacy and toxicity of liposomal daunorubicin when added to     fludarabine, ara-C and G-CSF(FLAG) in children with relapsed and refractory AML.   "
179627|NCT00187668|"     Collect DNA from well-characterized healthy volunteers.   "
179542|NCT00186537|"     Approximately 1/4 of the US population has insulin resistance and the associated risk factors     such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver     produces and low HDL cholesterol which is the good cholesterol helping to protect against     heart disease. Currently one known treatment for this a medication called fenofibrate,     another medication that can improve insulin resistance is rosiglitazone, a third treatment     known to improve insulin resistance an decrease triglycerides is weight loss. In this study     insulin resistant individuals with elevated triglycerides and or a ratio of triglycerides to     HDL cholesterol of 3:1 or greater will be randomized (selected by chance) to receive one of     these treatments and results of insulin sensitivity and cardiac risk profiles will be     compared at the end of the study.   "
179543|NCT00186550|"     This study will examine the effectiveness of supportive-expressive group therapy plus     education compared with an educational intervention in improving the quality of life and     promoting health-enhancing behavior of men and women living with HIV or AIDS.   "
179544|NCT00186563|"     This study aims to establish a novel approach assisting the rational development of analgesic     and anti-inflammatory drugs. In a first step we will test in healthy human volunteers whether     proteins mediating inflammation and pain can be detected in an experimentally induced     inflammatory skin lesion. Fluids that will be used to detect such proteins will be collected     from the inflamed skin site via small porous catheters. We wish to establish the expression     pattern of different proteins and correlate it with various tests assessing pain.   "
179545|NCT00186576|"     To improve survival outcomes for patients with MDS and MPD with a nonmyeloablative allogeneic     hematopoietic cell transplant.   "
179547|NCT00186602|"     Women indicate the greatest needs for counseling at the time of initial diagnosis for primary     breast cancer. The time of initial diagnosis is also often the time of greatest need for     information for women and their families. However, this is the time when a woman, overwhelmed     by shock and trauma, is least likely to absorb information provided or seek new sources of     information. An informed peer navigator with carefully trained communication skills can judge     the level of information to disclose and pace that information in a way that can be easily     absorbed and understood. She will also provide support. WomenCARE, a well-established Santa     Cruz agency providing free support services for women with cancer, and the Psychosocial     Treatment Lab at Stanford therefore ask whether women newly diagnosed with breast cancer will     improve their quality of life by participating in a peer navigator program. WomenCARE's peer     navigators provide emotional support, good listening skills, and information on resources for     women just diagnosed with breast cancer. Having a peer counselor while a woman goes through     treatment may reduce the magnitude of distress or shorten its time course. It may also reduce     distress in family members, and improve relationships with medical personnel.      This study is designed to evaluate the effectiveness of a peer navigator program where a     woman newly diagnosed with breast cancer is carefully matched for 3 to 6 months after     diagnosis with a trained volunteer who is herself a breast cancer survivor. Navigators and     Sojourners (newly diagnosed women) are matched on things that are important to them. Women     often want to be matched on the type of surgery or treatment they have received. We assign     half of the women (by a process similar to a coin toss) to our peer navigator program and     half to a group that receives standard medical care but no peer navigator. In this way we can     compare the groups to see whether those matched with a peer navigator have better quality of     life over the 3 to 6 month period. All women who join our study, regardless of the group to     which they are assigned, get an extra consultation with a nurse specialist at a local     hospital. In this consultation, the nurse reviews the cancer resources available to the woman     in Santa Cruz County. This meeting is tailored to the woman’s individual diagnosis and     situation.   "
179548|NCT00186628|"     To determine if Rituximab administered after allogeneic transplantation decreases the     incidence of chronic GvHD   "
179549|NCT00186641|"     To determine survival outcomes for patients with chemosensitive brest cancer after treatment     with high dose chemotherapy   "
179550|NCT00186654|"     This study evaluates the efficacy of acupuncture and massage for the treatment of depression     during pregnancy. The study also examines differential effects of study treatments on     delivery outcome and post partum depression.   "
179551|NCT00186667|"     Evaluate the clinical activity of sirolimus in combination with cyclosporine and     corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.   "
179552|NCT00186680|"     Evaluate the feasibility and safety of autologous transplantation of CD34+Thy-1+     hematopoietic stem cells afer high dose marrow ablative chemotherapy in patients with breast     cancer.   "
179553|NCT00186693|"     Airway hyperresponsiveness is a characteristic feature of the asthma. It is known that there     is an association between airway hyperresponsiveness and eosinophilic airway inflammation.     However, even though inflammation can be reduced with appropriate asthma therapy, it is     typical that airway hyperresponsiveness improves only modestly with treatment. The     determinants of airway hyperresponsiveness are unclear.      It is also not clear as to the site of airway narrowing in asthma. It is hypothesized that     airways beyond the 4th order have the greatest resistance.      We hope to determine the relationships between the airway inflammation, remodeling of the     airway and airway hyperresponsiveness. Through local instillation of methacholine at     bronchoscopy we will be able to study proximal and distal airways and the extent to which     they constrict in vivo   "
179554|NCT00186706|"     Does an oral selenium supplement increase blood levels of antioxidants in patients with     established, smoking-related lung disease?      Members of our study group recently discovered that elevated levels of the anti-oxidant GPx-1     may be protective against heart disease. We are studying whether selenium supplementation     will improve GPx-1 levels.   "
179555|NCT00186719|"     A breathing condition known as chronic obstructive pulmonary disease (COPD) caused by     cigarette smoking is a major health problem. The way by which smoking leads to lung disease     is uncertain. Recent research done in animals provides a description of specific changes     (that is a reduction) in these immune cell types as a result of cigarette smoke exposure. The     study you have been asked to participate in is a pilot study to see if similar changes occur     in humans who smoke. The purpose of this study is to evaluate this new method of testing     blood in 3 groups of 10 people: normal non-smoking subjects, subjects who smoke with no     history of lung disease and subjects who smoke and have smoking related COPD.   "
179556|NCT00186732|"     This study compares methods of closure for Pfannenstiel incisions commonly used during     gynecological and obstetrical surgery. Patients are assigned to closure by either surgical     staples or a buried suture. Information is collected on the day of surgery, post-operative     day two and at the six-week follow up visit. The amount of pain and cosmetic result are     compared. Infection rates will also be monitored for the two groups.      The study hypothesis is as follows: subcuticular (buried) sutures as compared to surgical     staples lead to decreased post-operative pain and improved cosmetic result. Infection rates     are similar for both groups.   "
179557|NCT00186745|"     Blood clots in the leg veins, known as deep vein thrombosis, are important because they may     travel to the lung (known as pulmonary embolism) and cause death. Blood clots are treated     with blood thinners, or anticoagulants. The preferred treatment is an anticoagulant known as     low molecular weight heparin (LMWH). LMWH is given by an injection under the skin, which is     convenient for patients because they can self-administer this medication at home, and no     blood testing is required. However, LMWH is cleared from the body through the kidneys, so     patients who have kidney failure are generally not treated with LMWH because they may be at a     higher risk of bleeding.      One type of LMWH, known as tinzaparin, may be less dependent on the kidneys for clearance and     may not increase in patients with kidney failure. The investigators would like to use     tinzaparin to treat patients who have deep vein thrombosis or pulmonary embolism, and who     also have kidney failure.      The purpose of this study is to determine whether the blood thinning effects of tinzaparin     build up, or accumulate, in patients with varying degrees of kidney failure compared to     patients without kidney failure. The blood thinning effects will be measured using a blood     test known as an anti-Xa level. Patients will be followed over the time they receive     tinzaparin and those patients who are found to have potentially high levels of tinzaparin     (based on the anti-Xa level) will have their tinzaparin dose adjusted. The investigators     believe that the levels of tinzaparin will not accumulate to potentially dangerous levels in     a significant number of patients with kidney failure.   "
179558|NCT00186758|"     To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic     Stimulation (rTMS)      to determine if non-responders can become responders if treated on the other side of the     hemisphere      (rTMS)   "
179906|NCT00201110|"     The purpose of this study is to test a measurement tool and a new training intervention for     problem solving in self-management of high cardiovascular disease (CVD) risk in African     Americans with type 2 diabetes.   "
179559|NCT00186771|"     Schizophrenia is a chronic, severe, and disabling brain disease. Auditory hallucinations are     the most frequent symptoms with an incident of 50% to 70% in patients.      Transcranial Magnetic Stimulation (TMS) can significantly reduce symptoms of schizophrenia.     TMS is capable of inducing changes in the electrical activities of the brain in humans.      The purpose of this trial is to study the use of TMS to decrease auditory hallucinations in     schizophrenia.   "
179560|NCT00186784|"     Repetitive Transcranial Magnetic Stimulation (rTMS) can improve mood and decrease sadness in     patients with depression.      In this study, the investigators seek to increase their understanding about how rTMS improves     depression, and to determine which form of rTMS is most effective for depression, when used     in combination with antidepressant medication.   "
179561|NCT00186797|"     This study is for patients with Severe Aplastic Anemia (SAA). A stem cell transplant from a     genetically matched sibling donor can help or cure this disease in 85 to 100 percent of     patients. Stem cells are immature blood cells that grow to become red blood cells, white     blood cells or platelets. A genetic match means a brother or sister has same immune type     (HLA type) as the patient. Unfortunately, few patients have a matched sibling donor. The     chance of negative outcomes is much higher with other types of donors.      This study will test the success of a new approach to stem cell transplant for SAA. Patients     in this study will receive drugs and radiation treatment to destroy their diseased bone     marrow and to prepare them for stem cell transplant. Bone marrow is the tissue inside the     bones where stem cells are made.Stem cells will be harvested from the blood or bone marrow of     genetically matched unrelated donors or partially matched family donors. The stem cells will     be filtered using a new device that is currently under study. The patients will receive large     doses of the filtered stem cells (stem cell graft). Researchers want to find out how the     study treatment affects patients, the disease, and the chances for survival.   "
179562|NCT00186810|"     This protocol studied the effect of administration of a myeloablative pretransplant     preparative regimen followed by an infusion of donor stem cells in children with severe     sickle cell disease. The donor graft consisted of bone marrow or cord blood derived from a     genetically matched sibling.      The primary aim of the study was to evaluate how well the donated cells migrated to the bone     marrow and begin producing healthy red blood cells, white blood cells and platelets     (engrafted), how well the recipients immune system recovered, and assess any regimen related     toxicities including a potentially life-threatening transplant related complication called     graft-versus-host-disease or GVHD.   "
179563|NCT00186823|"     Blood and marrow stem cell transplant has improved the outcome for patients with high-risk     hematologic malignancies. However, most patients do not have an appropriate HLA (immune type)     matched sibling donor available and/or are unable to identify an acceptable unrelated HLA     matched donor through the registries in a timely manner. Another option is haploidentical     transplant using a partially matched family member donor.      Although haploidentical transplant has proven curative in many patients, this procedure has     been hindered by significant complications, primarily regimen-related toxicity including     graft versus host disease (GVHD) and infection due to delayed immune reconstitution. These     can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens     when the donor T cells recognize the body tissues of the patient (the host) are different and     attack these cells. Although too many T cells increase the possibility of GVHD, too few may     cause the recipient's immune system to reconstitute slowly or the graft to fail to grow,     leaving the patient at high-risk for significant infection.      This research project will investigate the use of particular pre-transplant conditioning     regimen (chemotherapy, antibodies and total body irradiation) followed by a stem cell     infusion from a mismatched family member donor. Once these stem cells are obtained they     will be highly purified in an effort to remove T cells using the investigational CliniMACS     stem cell selection device. The primary goal of this study will be to determine the rate of     neutrophil and platelet engraftment, as well as the degree and rate of immune reconstitution     in the first 100 days posttransplant for patients who receive this study treatment.     Researchers will also study ways to decrease complications that may occur with a transplant     from a genetically mismatched family donor.   "
179564|NCT00186836|"     Does vaccinating hemodialysis patients with Twinrix® (combination vaccine against hepatitis A     and hepatitis B) result in a difference in hepatitis B antibody response in comparison to the     monovalent hepatitis B vaccine? Hepatitis B infection is an important cause of mortality and     morbidity. Current standard vaccination practices have low efficacy levels in patients (eg.     hemodialysis patients) who are most susceptible of infection. Efficacy of the two regiments     will be studied.   "
179565|NCT00186849|"     This is a Phase II pilot study of chemotherapy and surgery for children with advanced stage     high-risk neuroblastoma utilizing topotecan during an upfront window and other active agents     during induction and intensification phases. The primary purpose is to estimate the response     rate to an upfront window of two cycles of intravenous topotecan. We hypothesize that the     topotecan window will be an effective therapy in terms of the response rate.   "
179575|NCT00186979|"     The purpose of this protocol is to estimate the maximum tolerated dose of gefitinib in     combination with fixed dose of irinotecan and vincristine in patients with refractory solid     tumors.   "
179566|NCT00186862|"     Neuroblastoma affects approximately 500 children a year in the United States. When the tumor     occurs in infants, it is frequently localized and responds well to therapy. Even disseminated     disease can be eradicated in about 75% of infants, and indeed may undergo spontaneous     remission. In older children, the prognosis is far worse, and 80% or more of those with     disseminated tumor can be expected to relapse within 3 years.      This study will utilize the concept of exploiting the immune system to eradicate     neuroblastoma. In tumors in which there is consistent expression of tumor specific antigens     as part of the malignant process, it may be possible to generate immune T-cells ex-vivo or     in-vivo by using the specific protein or peptide(s) derived therefrom and eradicate the     tumor. This study will evaluate the use of four to eight injections of IL-2 gene-transduced     autologous neuroblastoma cells to induce a local, polyclonal T-cell infiltrate as well as an     anti-tumor immune response.   "
179567|NCT00186875|"     The main purpose of this study is to find out how well participants with relapsed or     refractory ALL respond to treatment with an etoposide- and teniposide-based induction     chemotherapy regimen and what the side effects are.      Primary Objectives:        -  To estimate the response rate for patients with refractory or relapsed ALL.        -  To estimate the survival rate of patients with refractory or relapsed ALL treated with          risk-directed therapy.   "
179616|NCT00187512|"     SCOPE is an observational, prospective study of HIV-1 infected volunteers designed to provide     a specimen bank of samples with carefully characterized clinical data. SCOPE specimens will     be used to examine multiple questions involving virologic, immunologic, and host factors     involved in HIV-1 infection, progression, non-progression, response to treatment, control of     HIV-1 virus, and evolution of drug resistance.   "
179568|NCT00186888|"     Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the     light sensitive layer of tissue that lines the back of the eyeball; sends visual messages     through the optic nerve to the brain. When only one eye is affected, this is known as     unilateral retinoblastoma and when both eyes are affected, it is called bilateral     retinoblastoma. Treatment for retinoblastoma is individualized for each patient and is based     on the form and the stage of the disease (inside the eye or has moved outside). The main goal     is always to cure the cancer, and save the life of the child. Treatments are also designed     with the hope of saving the vision, while completely destroying the tumor. Therapies may     involve surgery, chemotherapy, radiation, and other treatments called focal treatments. Focal     treatments may be laser therapy, freezing, or heat treatments meant to shrink and kill the     tumor.      In this study, researchers want to investigate how different participants respond to     different therapies that are individualized specifically for them. Participants will be     divided into three main groups, depending on whether the disease is unilateral or bilateral,     and the stage of the disease. One of the main objectives of the study is to investigate how     advanced tumors in children with bilateral disease respond to a new combination of     chemotherapy with topotecan and vincristine, with G-CSF support. In order to improve results,     some children with very advanced disease may receive carboplatin chemotherapy given around     the eye at the same time that they receive topotecan by vein. Also, because children with     retinoblastoma are diagnosed so early in life and the vision may be significantly impaired,     this study will investigate how children develop and how the brain adjusts and compensates     for the visual deficits. Finally, this study also investigates the biology of retinoblastoma,     in order to understand better how this cancer develops.   "
179569|NCT00186901|"     Research studies have shown that children who are long-term survivors of childhood leukemia     may be at greater risk for early bone loss called osteoporosis. This bone loss may lead to a     greater risk of broken bones and other spine and bone problems. However, researchers still do     not know much about how frequently this long-term side effect may occur and how severe the     problem is.      St. Jude Children's Research Hospital researchers want to determine the frequency and     severity of this side effect. They are also studying whether taking calcium and Vitamin D     supplements can help children at risk for osteoporosis and if certain factors can be     identified -- such as age at diagnosis, cancer treatments, or family history -- that may     increase the chances of having osteoporosis. Researchers will take an x-ray study called     quantitative computed tomography (QCT) to measure bone mineral density (BMD). The BMD is a     measure of bone strength. If a subject's BMD falls below the average, he/she will be assigned     to one of two groups. Subjects will be randomly assigned (like tossing a coin) to receive     calcium and vitamin D pills. The other half will receive placebo pills that look like the     calcium and vitamin D pills.   "
179570|NCT00186914|"     Osteodysplasia or poorly formed bones, brittle bones is a genetic disease with no known     proven treatments. Some forms of osteodysplasia may cause severe disability and even death.      Eligible patients were limited to those children with Osteodysplasia who had undergone a     previous allogeneic bone marrow transplant at St. Jude. The study intervention involved an     infusion of a specified number of ex vivo expanded stromal cells obtained from the bone     marrow of the same donor from whom they received their primary transplant procedure. These     bone marrow stromal cells can become bone-forming cells, called osteoblasts. Participants     then received 2 infusions of ex vivo expanded, gene marked cells not less than 6 months after     bone marrow transplantation. The second cell infusion occurred between 14 to 21 days after     the first infusion in the absence of toxicity. The goal of the study was to evaluate the     safety and toxicity of these infusions.   "
179571|NCT00186927|"     Croup is an illness of young children that is caused by a virus. With this illness, the child     has fever, cough, and hoarseness. Although the illness usually gets better in 2 to 4 days,     some children may be admitted to the hospital and a few infants may require an intervention     to help their breathing. This illness is most often caused by a virus called parainfluenza     virus type 1, but it can be caused by other viruses. The experimental vaccine that is being     investigated in this study is intended to try to prevent croup caused by parainfluenza virus     type 1. Currently, there are no vaccines to prevent this virus, or medications available to     treat the illness once infection has occurred.      This research study is testing a new experimental live-virus vaccine that is given by placing     liquid drops in the nose. The Sendai virus is very similar to the virus that causes croup,     but it has never been found to cause illness in people. Previous studies in animals have     shown that the vaccine provided protection against the croup virus, and did not cause     illness. Many people have been exposed to the Sendai virus, but no one has been known to     develop illness. Several healthy adults have been given the Sendai virus vaccine being     studied, and they did not experience any serious side effects or illness.   "
179572|NCT00186940|"     This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome     who have a history of asthma/atopy. The main purpose of this study is to establish the safety     of this drug in patients with a history of asthma or severe allergies.   "
179573|NCT00186953|"     St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to     be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves     to create pictures, allowing doctors and other medical professionals to see inside the     body.      Researchers are studying a contrast agent (like a dye) called Optison™. St. Jude Children's     Research Hospital researchers want to learn the best and safest dose of this ultrasound     dye.   "
179693|NCT00188539|"     The aim of this study is to measure the oxygen content and interstitial fluid pressure in     cervix cancer patients. Tumour oxygen content and internal pressure of tumours may be an     important factor that influences the effectiveness of radiotherapy and other treatments.   "
179576|NCT00186992|"     Researchers at St. Jude Children's Research Hospital are looking for more effective ways to     deliver radiation therapy to pediatric tumors of the bone and soft tissues. The goal of the     study is to improve local control of musculoskeletal tumors with image-guided radiation     therapy (IGRT) while minimizing radiation related side effects. IGRT uses computed tomography     (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) images to     precisely define tumor location and to carefully plan radiation treatment. This approach     allows doctors to deliver highly conformal radiation therapy to the tumor while protecting     nearby healthy normal tissues.   "
179577|NCT00187005|"     The main purpose of this study is to find out if radiation to the central nervous system     (CNS) can be safely omitted with early intensification of chemotherapy and chemotherapy given     directly to the CNS. Another purpose is to find out if survival of children with ALL can be     improved with risk-directed therapy given on this protocol.   "
179630|NCT00187720|"     The current study is part of a large multi-investigator grant to look at the pharmacogenetics     of a number of membrane transporters. We will study individuals with particular genotypes of     the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation     in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent,     metformin.   "
179578|NCT00187018|"     Osteogenesis imperfecta (OI) is a genetic disease for which there is currently no known cure.     OI causes the osteoblasts (bone-forming cells in the body) to grow poorly, which slows the     growth of children with the disease and causes their bones to bend and break easily. Some     forms of osteogenesis imperfecta may cause severe disability and even death. In previous     research studies performed at St. Jude, it was found that children treated with bone marrow     transplant (infusion of healthy immature blood-forming cells) began to grow faster, had more     minerals (material that helps make the bones strong) in their bones, and broke their bones     less often than before the bone marrow transplant. Several months after the bone marrow     transplant however, body growth once again began to slow down. In this research study,     children with osteogenesis imperfecta will receive another infusion of bone marrow cells but     without any chemotherapy. The marrow cells will come from the same bone marrow donor as their     previous bone marrow transplant. It is hoped that by removing the CD3+ cells (a type of white     blood cells that attack other cells that are not like themselves) from the donated bone     marrow, the subject's body will be infused quite safely and that body growth and bone     strength will increase. The CD3+ cells will be removed from the donor bone marrow by use of a     machine called the CliniMACS System. This machine has not been approved for use in the United     States by the Food and Drug Administration (FDA). The use of this device is considered     experimental.   "
179579|NCT00187031|"     In spite of the overall success of treating Wilms tumor, certain patients still have poor     clinical outcomes. The sub-optimal outcomes for patients with anaplastic histology and     recurrent Wilms tumor warrant the identification of new therapeutic agents. The objective of     this trial is to estimate the response rate to two cycles of intravenous topotecan in     children with recurrent Wilms tumor of favorable histology that is refractory to standard     curative therapy.   "
179580|NCT00187044|"     This is a research study to evaluate the safety of a vaccine to protect people from HIV     infection. Human Immunodeficiency Virus (HIV) is the cause of AIDS (Acquired Immune     Deficiency Syndrome). AIDS is one of the most serious viral infections of our time. It is     believed that all persons who contract HIV will eventually develop AIDS. Because of this, we     are trying to develop new ways to prevent infection with HIV.      The vaccine that will be tested in this study has been prepared from a small part of the HIV.     The part of the HIV used in this vaccine is the envelope or coating part of the virus. In     this study, researchers will evaluate how well the vaccine is tolerated, how much vaccine     should be given, and determine if any side effects occur in response to the vaccination.   "
179581|NCT00187057|"     This is a pilot/feasibility study designed to investigate the feasibility of treating     children with Ataxia-Telangiectasia (A-T) and cancer with regimens nearly as intense as     non-A-T patients with cancer would receive.   "
179582|NCT00187070|"     The main purpose of this study is to find out if it is feasible to deliver a multi-agent     chemotherapy regimen which features a shorter, more intensive, immunophenotype-directed     approach, and includes an intensification phase with hematopoietic stem cell support for     children with large cell lymphoma   "
179583|NCT00187083|"     The main purpose of this study is to find out which form of asparaginase (the native E.     coli/Erwinia) or PEG-asparaginase) is more effective during induction treatment for children     with acute lymphoblastic leukemia that has come back after treatment (relapsed) or is     resistant to treatment (refractory)   "
179584|NCT00187096|"     The purpose of this study is to assess the safety and efficacy of infusing natural killer     cells from a donor as treatment for patients with acute myeloid leukemia in remission or who     have experienced relapse.   "
179585|NCT00187109|"     Life-threatening thrombocytopenia (low platelet count) and neutropenia (low white blood     count) remain the major dose-limiting toxicities following chemotherapy treatment for cancer.     The only remedy for thrombocytopenia at present is platelet transfusion, which is effective     in preventing life-threatening hemorrhage, but may lead to other complications. Preclinical     studies and studies in adults have shown recombinant human thrombopoietin (rhTPO) to be     effective in stimulating platelet production. The initial phase of this trial will evaluate     the safety of rhTPO use immediately after chemotherapy with ifosfamide, carboplatin, and     etoposide in children with solid tumors and lymphomas. The second phase of the study will     evaluate the effectiveness of rhTPO in decreasing the duration of low platelet count after     chemotherapy.   "
179586|NCT00187122|"     The main purpose of this study is to determine if it is feasible to administer an     intensified, multi-agent chemotherapy regimen for children with stage III and IV non-Hodgkin     lymphoma and to find out what the toxicities are.   "
179587|NCT00187135|"     St. Jude Children's Research Hospital is studying the best ways to prevent pain during and     after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the     spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics     (medicines that help people sleep) and analgesics (medicines that relieve pain). Researchers     believe that a combination of fentanyl (analgesic) and propofol (anesthetic), along with     applying the skin-numbing-cream EMLA or L.M.X4™ on the area where the procedure is performed,     will provide better pain control.      Each patient enrolled on this study will have three different anesthetic combinations for     three different procedures, in order to determine which combination worked best for each     child.   "
179997|NCT00192452|"     - The primary objective of this study is to compare disease activity, as measured by PASI     score, of two MEDI-507 dose levels (0.012 and 0.04 mg/kg) versus placebo administered by     intravenous infusion every 2 weeks for a total of 8 infusions.   "
179588|NCT00187148|"     This protocol will evaluate the safety and tolerability of the vaccine EnvDNA in healthy     adults. DNA-based vaccines are being studied for the prevention of human immunodeficiency     virus (HIV), malaria and hepatitis. DNA vaccines have been well tolerated in human studies to     date. The vaccine that will be tested in this study was made from the information that the     virus uses to make a small part of the HIV. This small part is called the envelope or coating     around the virus. We hope the body will make an immune response against the HIV envelope     coat. Our potential HIV DNA envelope vaccine is called EnvDNA.   "
179589|NCT00187161|"     This is a pilot study to demonstrate that the modified LMB-89 treatment regimen for children     with newly diagnosed small noncleaved cell NHL, large cell NHL (B-cell), and B-cell acute     lymphoblastic leukemia can be delivered in this setting with acceptable toxicity.   "
179590|NCT00187174|"     Patients with recurrent or refractory solid tumors or brain tumors that are unresponsive to     conventional therapy, or with no known effective therapy, will be treated. Experiments in the     laboratory have shown the experimental drug RAD001C (RAD001, Everolimus) can prevent cells     from multiplying. RAD001 is now being tested in diseases such as cancer, in which excessive     cell multiplication needs to be stopped. The drug has been tested in adult cancer patients     and has been well tolerated by subjects in these studies. It is experimental and, therefore,     available in clinical trials.   "
179591|NCT00187187|"     The DAVID II Clinical Study evaluates the hypothesis that, in patients needing an ICD but     without overt indications for pacing, AAI pacing with maximal concomitant drug therapy will     not increase the rate of the combined endpoint of mortality or hospitalization for new or     worsened heart failure as compared to patients with ventricular backup pacing.   "
179592|NCT00187200|"     The purpose of the study is to evaluate the benefit of interventricular (V-V) delay     optimization in reducing the non-responder rate in patients with cardiac resynchronization     defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.      For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH     of the following requirements are fulfilled:        -  < 10% improvement in 6-minute hall walk, and        -  no class improvement or worsening in New York Heart Association (NYHA) scale.      For those receiving CRT-D devices as replacements of older CRT-D systems, patients are     considered non-responders if BOTH of the following requirements are fulfilled:        -  > 1 heart failure (HF) related hospitalization, and        -  no class improvement or worsening in NYHA scale.   "
179593|NCT00187213|"     The purpose of this study is to demonstrate that biventricular pacing (BiV) and left     univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac     resynchronization therapy in heart failure patients implanted with a cardiac     resynchronization therapy defibrillator (CRT-D) device.      The hypothesis to be tested by this clinical investigation is that patients indicated for an     ICD with cardiac resynchronization therapy respond as well to LV only pacing as to BiV     pacing.   "
179594|NCT00187226|"     The purpose of the study was to determine if treating a limited volume of normal tissue     surrounding the tumor or tumor bed using conformal radiation therapy would achieve similar     rates of disease control compared to standard radiation therapy. The study was also conducted     to examine the effect of irradiation on neurological, endocrine and cognitive function.   "
179595|NCT00187239|"     The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM)     implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction     Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two     methods of programming with respect to intrinsic activity.   "
179596|NCT00187252|"     The purpose of this study is to evaluate whether adding AF Suppression™ to cardiac     resynchronization therapy (CRT) improves the prognosis of heart failure patients benefiting     from cardiac resynchronization therapy.   "
179597|NCT00187265|"     The purpose of this study is to evaluate the feasibility of permanent biventricular pacing     using three ventricular leads, and its efficacy in terms of inter and intra-ventricular     resynchronization, in patients with congestive heart failure and a non-functional atrium     (chronic AF).   "
179598|NCT00187278|"     The primary purpose of the study is to evaluate if patients with a standard indication for     permanent ventricular pacing, left ventricular ejection fraction without limit, or any QRS     duration will profit from the prevention of ventricular desynchronisation.   "
179599|NCT00187291|"     The ABCD clinical study is designed to determine if a T-Wave Alternans (TWA) test is     equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms     in patients with ischemic heart disease, left ventricular dysfunction, and non-sustained     tachycardia. Patients undergo both the TWA test and EP study and receive an Implantable     Cardioverter Defibrillator (ICD)if either of the tests show the patient is at risk. The     patient is then followed for 2 years. The incidence of a ventricular tachyarrhythmia events     and total mortality are to be evaluated over the duration of the study.   "
179600|NCT00187304|"     The primary objective of this study is to compare two different regimens of therapy, AVK and     ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM     Epic™ or SJM Epic™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event     free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus     on thromboembolic events and bleedings).   "
179601|NCT00187317|"     This study aims to investigate the potential to train compensatory stepping and grasping     reactions for the prevention of falls.   "
179610|NCT00187434|"     Continuous positive airway pressure (CPAP) has been used successfully to promote extubation     in the premature infant population. The two methods of CPAP to be examined are currently used     by many institutions, yet no study has compared these methods to determine which is better in     the population of newborns < 1500 grams (birth weight) at supporting extubation. This     randomised controlled study will examine two types of CPAP: the Infant Flow System and the     Bubble CPAP. This randomised controlled, single site, clinical study is to determine whether     the Bubble CPAP or the Infant Flow System (IFS) CPAP is more effective at supporting the     extubation in infants of birth weights < 1500 grams. Seventy-six infants will be randomised,     immediately prior to extubation, to IFS or Bubble CPAP of 5 cmH2O. The primary outcome is     successful extubation, defined as not reaching failure criteria for the 7 days     post-extubation. Failure criteria are defined as pH < 7.25 and PCO2 > 65 mmHg or a sustained     increase in FiO2 of 0.15.   "
179614|NCT00187486|"     The patients eligible for this study are those diagnosed with glioblastoma or gliosarcoma who     have recently undergone surgery and who have not been treated with radiation therapy or     chemotherapy. This is called a phase II study. The purpose of the phase II study is to     determine how effective Tarceva plus Temodar plus radiation is in controlling the growth of     glioblastoma and gliosarcoma. All patients will receive radiation and Temodar plus Tarceva.     There is no placebo drug.   "
179615|NCT00187499|"     The purpose of this study is to determine whether an inhaled corticosteroid (fluticasone)     alters the expression of any gene expressed in the lining of the airways of asthmatics. The     study uses high density gene chips which allow the study investigators to measures all gene     in the human genome. We hypothesize that this approach will identify novel genes that are     affected by steroids in asthmatics.   "
179602|NCT00187330|"     N-acetylcysteine is a medication that has most commonly been used in the past to prevent     liver damage after an acetaminophen overdose. N-acetylcysteine has also been used in patients     with pre-existing kidney damage to prevent further kidney damage resulting from dye that is     used in tests such as angiograms (dye studies). This study hopes to prove that this     medication may also help to protect kidneys from the damage caused by the heart-lung machine     during cardiac surgery. This damage to the kidneys happens to patients undergoing cardiac     surgery requiring the use of the heart-lung machine. Kidney failure after surgery is a     serious complication (2-30% of patients with kidney problems can develop it) and it can lead     to short term and long-term dialysis as well as death (there is up to a 30% death rate once     kidney failure develops). The study will test if intravenous N-acetylcysteine is safe and     effective in preventing kidney problems after cardiac surgery using the heart-lung machine.     Approximately 104 patients will be enrolled at Sunnybrook and Women’s College Health Science     Centre. The study has been reviewed and approved by the ethics committee at Sunnybrook and     Women’s College Health Science Centre. The study will compare the effects of N-acetylcysteine     with those of placebo (salt solution). The study medication (either N-acetylcysteine or     placebo) will be given in addition to your usual medication and surgical procedures.   "
179603|NCT00187343|"     The purpose of this study is to determine whether the use of a 3D missing tissue compensation     radiation technique during a standard adjuvant breast radiotherapy delivering a dose of 50Gy     in 25 treatments could reduce significantly the occurence rate and the degree of acute skin     reaction compared to a standard wedged irradiation technique.   "
179604|NCT00187356|"     Bypass surgery is often required to treat severe coronary heart disease. Either arteries or     veins can be used as bypass grafts. We wish to compare the long-term durability of the     saphenous vein from the leg to that of the radial artery from the fore-arm when used as     bypass grafts. We are examining how many of these grafts are still functioning beyond 5 years     after bypass surgery by performing a coronary angiogram. After 1-year, we found that radial     arteries were more likely to be functioning than saphenous veins. We hypothesize that radial     arteries will continue to be superior beyond 5 years.   "
179605|NCT00187369|"     For twin pregnancies at 32-38 weeks gestation, where twin A is head down, does a policy of     planned caesarean section (CS) lower the likelihood of death or serious illness, during the     first 28 days after birth, compared to a plan for vaginal birth (VB)?   "
179606|NCT00187382|"     In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have     not had their baby by 14 or more days after being given a single course of antenatal     corticosteroids (ACS), do repeated courses of ACS every 14 days until 33 weeks' gestational     age lower the risk of illness or death in babies compared to repeated courses of placebo.     Children are assessed at 2 years and 5 years for neurodevelopmental impairment.   "
179607|NCT00187395|"     Prior to undertaking CHIPS which will be a large and difficult trial, we believe we need to     first determine whether clinicians will comply with the interventions of 'less tight' and     'tight' control of dBP, and whether the interventions will result in differences in mean dBP     between groups. A pilot will also allow us to confirm the ability of centres to identify     eligible women and the willingness of women to join CHIPS.   "
179608|NCT00187408|"     It is known that patients who fracture their legs sometimes develop blood clots (known as     deep vein thrombosis) in their legs. These clots may cause pain and swelling in the leg or     they may detach and travel to the lungs producing shortness of breath, chest pain, and     sometimes death. Unfortunately, it is not known how frequently these complications occur     after leg fractures, or if the use of a blood thinner medication can effectively and safely     prevent these clots. Doctors at hospitals across Canada are conducting a study in which     patients who have surgery for leg fractures receive either a once-daily injection of a blood     thinner, known as low molecular weight heparin, or a placebo injection for up to 14 days     after their fractures. Neither the patients nor the doctors know which patient is on the     medication and which patient is on placebo. All patients receive an ultrasound examination of     their legs at 2 weeks after surgery to monitor for deep vein thrombosis. In addition, all     patients are checked for symptoms of leg or lung clots and any side effects of the medication     for 3 months. If the blood thinner is shown to be effective at reducing this complication and     documented to be safe and cost-effective in this setting it will be recommended for use in     such patients. If, on the other hand, the frequency of deep vein thrombosis is too low to     justify the cost or inconvenience of taking this medication, this will also be an important     finding.   "
179609|NCT00187421|"     The primary objective of the proposed study is to determine if a strategy of intraoperative     patency assessment and graft revision can decrease the rate of graft occlusion or significant     stenosis (>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional     operative management without routine intraoperative patency assessment. Patency will be     assessed with a new fluorescence angiography technique as well as ultrasonic transit-time     flow measurement. We hypothesize that the strategy of intraoperative patency assessment and     graft revision will significantly reduce the frequency of graft occlusion at 6-12 weeks in     comparison to patients who do not have intraoperative patency assessment. We also hypothesize     that the strategy of intraoperative patency assessment and graft revision will significantly     reduce the frequency of 50-99% stenoses at 6-12 weeks in comparison to patients who do not     have intraoperative patency assessment. We expect both groups will experience similar     perioperative outcomes but hypothesize that patients receiving a strategy of intraoperative     patency assessment and graft revision will experience improved long-term graft patency and     freedom from late clinical events at 5-6 years post-operatively.   "
179611|NCT00187447|"     The purpose of this study is to examine if a higher dose of indomethacin will increase the     rate of ductus arteriosus closure in extremely premature infants without increasing the side     effects. The long term objective is to find the optimal dosing of indomethacin for permanent     closure of the Ductus and prevent the morbidity related to PDA and the complications of     surgical ligation.   "
179612|NCT00187460|"     Randomized cluster trial of cardiac report cards for AMI and CHF. 103 acute care Ontario     hospitals/85 hospital corporations participating, randomized to two groups: Group A Early     Feedback and Group B Delayed Feedback.      Two phases of retrospective chart review of AMI and CHF separations to assess the impact of     the public release of hospital specific performance on a set of Canadian quality indicators.   "
179617|NCT00187525|"     This is a 52-week, multicenter, open label trial of memantine (Namenda) for frontotemporal     lobar degeneration (FTLD). The goal is to determine the safety and tolerability of this     FDA-approved medication for Alzheimer's Disease in patients with FTLD. Secondary outcome     measures include cognitive batteries, rating scales for activities of daily living and     neuropsychiatric symptoms. All patients receive the FDA-approved dose of this medication for     Alzheimer's disease.   "
179618|NCT00187538|"     Osteoporosis is a major health concern worldwide. While there are drugs available for the     treatment and prevention of osteoporosis, they are not practical for population-wide     prevention efforts. Demonstrating the effectiveness of safe and widely available dietary     interventions to prevent osteoporosis could have important public health ramifications.     Different food sources of dietary protein may have different effects on bone metabolism.     Animal foods provide a dietary acid load that may lead to negative calcium balance and     increased bone resorption. In contrast, vegetable sources of protein, while providing some     acid due to their protein content, provide proportionally more base that counters the dietary     acid load. The effect of dairy products, which are rich in animal protein but also contain     potential base precursors not found in vegetable foods, has not been established. Finally,     soy protein sources may have a dual benefit: soy foods provide base precursors as well as     plant estrogens that may have a beneficial effect on bone. We are resubmitting this proposal     to randomize postmenopausal women to one of four diets equal in calories, protein, calcium,     and sodium. The diets will differ by having 80 percent of the protein from one of four     sources: non-dairy animal, vegetable, dairy, or soy foods, resulting in significant     differences among the diets in acid, base, and isoflavone content. All food will be prepared     and provided by the General Clinical Research Center. The subjects will consume the diets for     6 weeks with measurements of acid-base status, isoflavone excretion, and calcium metabolism.     This will be the first intervention study to examine the effect of different sources of     dietary protein in whole foods on calcium metabolism. Eventually our findings could have     substantial public health implications and provide a widely available and low risk means to     help prevent osteoporosis.   "
179619|NCT00187551|"     The goal of this study is to examine whether enfuvirtide (T20, Fuzeon) has continued anti-HIV     activity in patients experiencing an incomplete virologic response to an enfuvirtide-based     regimen.   "
179620|NCT00187564|"     The long-term effects of high blood sugar include blindness, kidney failure, and nerve damage     that can ultimately cause loss of limbs. Research has shown that high blood sugar increases     the amount of reactive oxygen species (ROS) produced in diabetics, and that the increase in     ROS causes damage to eyes, kidneys, and nerves by a process called oxidative stress. We     postulate that alpha-lipoic acid, a potent anti-oxidant, can stop ROS from forming, thereby     preventing long-term complications in diabetes. In this pilot study, we will be giving 30     teenagers with type 1 diabetes (T1D) controlled-release alpha-lipoic acid for 3 months, and     comparing the amount of oxidative stress before and after treatment. Ten teenagers with T1D     will receive placebo instead of alpha-lipoic acid and undergo the same research protocol to     aid in validation of outcome measures.   "
179621|NCT00187577|"     This is a single center, randomized, investigator-masked study to determine the efficacy and     safety of latanoprost and bimatoprost ophthalmic solutions in promoting eyelash growth in     patients who have lost their eyelashes due to alopecia areata. These medications are     FDA-approved as eyedrops for patients with glaucoma who have been noted to grow longer,     darker, and thicker eyelashes with their use. In this study, patients will be asked to apply     these solutions to the affected eyelid margins of one eye with a sterile cotton-tipped     applicator once a day.   "
179622|NCT00187590|"     Case management has become an integral part of HIV care. There is little science however     demonstrating its effectiveness. This is a randomized, controlled trial of a phone call     intervention after an ER visit to see if this can reduce further ER visits, hospitalizations,     deaths, and cost.   "
179623|NCT00187603|"     Among all racial/ethnic groups, African Americans have the greatest risk of becoming ill or     dying from tobacco-related diseases. Because of this disproportionate disease burden, it is     particularly urgent that researchers focusing on tobacco control partner with African     American communities. Intervention strategies which hold the tobacco industry accountable for     its behavior are effective in changing views of tobacco use. In earlier work, the     investigators found that information from internal tobacco industry documents, when shown to     African American smokers, stimulated reflection about quitting and interest in disseminating     information about industry targeting behaviors to others. However, to date there have been no     attempts to utilize the information in industry documents as part of a smoking cessation     intervention. In this project, the investigators will test whether a community co-developed,     tailored quit-smoking program featuring exposures to African American-specific tobacco     industry documents and media exercises in addition to proven individual quitting strategies     can increase the number of people who quit smoking at six months and one year, as compared     with usual care.      The specific aims of the project are to:        1. test, using statistics, how well an innovative community-based, culturally tailored          quit-smoking program for African Americans works at 6 and 12 months;        2. test selected variables for how well they predict who will return to smoking;        3. use interviews to identify additional individual and/or community factors associated          with successful quitting or relapse; and        4. collect information to evaluate the overall effectiveness of the CARA project          collaborative efforts in developing and sustaining the project over time, enhancing          community awareness of tobacco issues, and creation or enhancement of community tobacco          control resources.   "
179624|NCT00187616|"     This trial studies whether 3 different methods of asking patients about adverse medical     events in a clinical trial affects the rate of reported side effects.   "
179625|NCT00187629|"     The purpose of this study is to determine the effects of different amounts of phosphorus in     the diet on hormones that control phosphorus and bone health both in men who are healthy and     in ones who have moderate kidney disease.   "
179626|NCT00187655|"     In the proposed study, we plan to use a genotype to phenotype strategy to study the role of     the organic anion transporter, OAT3, in drug response. More specifically we will examine the     contribution of OAT3 to the renal clearance of anionic drugs such as cefotaxime by studying     individuals with a non-functional (or poorly-functional) variant of OAT3.   "
179628|NCT00187681|"     Specific Objectives:        -  To determine if individuals who carry a decreased or non-functional variant of OCT1          exhibit differences in the pharmacokinetics of metformin in comparison to individuals          who carry the common allele.        -  To determine if individuals who carry the decreased or non-functional variants exhibit          differences in the response to metformin in comparison to individuals who carry the          common allele.   "
179629|NCT00187707|"     The current study is part of a large multi-investigator grant to look at the pharmacogenetics     of a number of membrane transporters. Previously, we have recruited a cohort of healthy     volunteers (Studies of Pharmacogenetics in Ethnically-diverse Populations, or SOPHIE) and     have resequenced the coding region of a number of membrane transporter genes to identify     genetic polymorphisms in these genes. We plan to take a genotype-to-phenotype approach to     study the influence of specific polymorphisms in the intestinal transporters, such as the     novel organic cation transporters 1 and 2 (OCTN1 and OCTN2) genes on the bioavailability of     gabapentin in healthy subjects. Eligible subjects will have a single inpatient study visit,     during which they will take a single dose of gabapentin, and provide blood and urine samples     over the course of 36 hours (5 terminal elimination gabapentin half-lives) for     pharmacokinetic analysis.   "
179631|NCT00187733|"     The current study is part of a large multi-investigator grant to look at the pharmacogenetics     of a number of membrane transporters. Previously, the investigators have recruited a cohort     of healthy volunteers (Studies of Pharmacogenetics in Ethnically-Diverse Populations, or     SOPHIE) and have resequenced the coding region of a number of membrane transporter genes to     identify genetic polymorphisms in these genes. Subjects in this cohort have agreed to be     called back for recruitment in further studies based on their own genetic sequence, allowing     the investigators the possibility to prospectively study the influence of genetic     polymorphisms on particular phenotypes (i.e., genotype-to-phenotype studies). The     investigators plan to take a genotype-to-phenotype approach to study the influence of     specific polymorphisms in the novel organic cation transporter 2 (OCTN2) gene on carnitine     and lipid metabolism in healthy subjects.   "
179632|NCT00187746|"     Healthy African American subjects with normal hepatic and renal function will be administered     10mg adefovir dipivoxil in a fasting state. Subjects will have blood and urine collections     over the following 24 hours for the measurement of adefovir renal clearance. To investigate     the role of age in renal adefovir elimination, 8 subjects will be enrolled from each of the     following age groups: 18-25 years and 48-55 years.   "
179633|NCT00187759|"     This study is to determine whether antibiotic therapy is needed for patients with non-life     threatening soft tissue infections. Most patients with these soft tissue infections are     presently treated with antibiotics. Many of these infections resolve without proper     antibiotic treatment. Treatment of patients with antibiotics after surgical drainage of an     abscess may not be necessary and indiscriminate use of antibiotics may lead to colonization     by drug-resistant organisms. Subsequent infection by drug resistant organisms may limit the     choice of antibiotics in more complicated infections. A comparison between antibiotic     treatment and no antibiotic treatment in surgically treated, uncomplicated soft tissue     infections is needed to address this very important question.   "
179634|NCT00187772|"     This study will examine the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of     preschoolers exposed to marital violence.   "
179635|NCT00187785|"     Does use of a translator or use of less than perfect Spanish diminish provider-patient     communication compared to a native speaker.   "
179636|NCT00187798|"     Specific Aims: To compare metformin pharmacokinetics in monozygotic and dizygotic twin pairs.     Comparing renal clearance of metformin in monozygotic and dizygotic twins will allow us to     better understand the influence of heredity on variation in renal elimination. Furthermore,     genotyping renal transporter genes in monozygotic and dizygotic twin pairs with significant     differences in renal clearance of metformin may give us insight into the genes responsible     for this variability.   "
179637|NCT00187811|"     Rstenosis is common after angioplasty of atherosclerotic disease of the femoral artery. Pilot     study data suggests that adjuvant photodynamic therapy, using delta amino kleavulinic acid as     a photosensitiserr is feasible and safe. This study will examine safety in a larger     population and,if recruitment numbers allow, efficacy will be assessed.      Hypothesis:      ALA photodynamic therapy is safe and well tolerated as an adjuvant to angioplasty as a     treatment for femoral artery atherosclerotic stenosis or occlusion. A secondary endpoint will     be sought : hypothesis : PDT will reduce in restenosis rates following adjuvant photodynamic     therapy compared with standard balloon angioplasty in the treatment of superficial femoral     arterial disease.   "
179638|NCT00187824|"     The hypothesis of this study is that bioenergetic failure in human sepsis, related to     endocrine, metabolic and mitochondrial dysfunction, is a major determinant of defective host     immune responses, increasing disease severity and risk of death. The objectives of this study     are to examine the relationship between the severity of illness, and temporal changes in the     activity of endocrine, metabolic and bioenergetic pathways, and consequent immune dysfunction     in critically ill patients with sepsis and multiple organ failure in the Intensive Care Unit.   "
179650|NCT00187980|"     The aim of this study is to 1-evaluate subjectively by questionnaires and objectively by     ambulatory actigraphy the quality of sleep in patients with newly diagnosed lung cancer; 2-     to correlate sleep quality index with quality of life, daytime alertness, Performans status     and lung cancer staging at diagnosis.   "
179694|NCT00188552|"     Patients with radiation induced injuries experience significant pain and negative effects on     quality of life. Currently, no standard therapy for these patients exists, with some patients     treated symptomatically, and others treated with hyperbaric oxygen or pentoxifylline/Vitamin     E. This study will examine prospectively the safety and efficacy of using a regimen of     pentoxifylline and vitamin E in patients with late radiation induced injuries.   "
180015|NCT00192699|"     This is a 10 year follow-up investigation of patients who have underwent total hip     arthroplasty with a cemented Bimetric stem.   "
179639|NCT00187837|"     Brief summary      Background:      A large proportion of dental practice involves the treatment of caries in the permanent     dentition. In USA alone tooth related pain is annually responsible for 15 billions days lost     through sickness. We do not know whether a stepwise excavation is better or worse compared     with one final completed excavation in adults with deep caries with or without pain. A deep     carious lesion is in the risk zone of being pulpal exposed during excavation.      Aim:      The aim of the CAP-1-trial is to investigate the beneficial effects of stepwise excavation     during two visits versus óne completed excavation of deep caries in permanent teeth with or     without pain.      Patients:      Consecutive patients contacting the units involved in the CAP trial for the treatment of deep     caries. The trial will comprise 300 patients.      Design:      CAP-1-trial is a randomised patient- and observer-blinded multicenter trial, with two     parallel intervention groups. Patients that fulfill the inclusions criteria and none of the     exclusions criteria, will be centrally bloc-randomised in Copenhagen Trial Unit, Copenhagen     DK, and stratified by age and pain. Allocation ratio is 1:1.      Interventions and products:      Patients are allocated for stepwise excavation in two visits or final excavation in one     visit. The patients will not be informed about the result of the randomisation, i.e. the type     of intervention. Therefore, all patients will be contacted for two visits. The second visit     in the stepwise excavation group wil be used for the second and final excavation, and for the     performance of a permanent restoration. The second visit in the one step excavation group     will solely be used for the performance of a permanent restoration. The interventions in both     groups are completed following 8-10 weeks after the randomisation.      A temporary calcium hydroxide based material is used in both groups (Dycal®). The temporary     restoration material, glas-ionomer cement is used (Ketac Molar®) in between visits, and a     resin material is used for the final restoration(Herculite®).   "
179663|NCT00188149|"     Prognosis of patients with Hodgkin´s lymphoma (HL) has been improved significantly over the     last decade. Therefore, the impact of treatment associated long-term toxicities and late     effects such as second cancers increased. The purpose of this prospective multicenter trial     is to show the feasibility of the treatment with ABVD alone in patients with limited stage     (HL1) and intermediate stage (HL2) disease and of an intensified etoposide-free chemotherapy     regimen for patients with advanced disease (HL3) including 18F-FDG-PET evaluation.   "
179640|NCT00187850|"     CAP-2 Trial      Background: This trial is being done in conjunction with an ongoing clinical trial     investigating stepwise excavation versus final excavation on deep caries lesions (The CAP-1     trial). The investigators lack systematic knowledge concerning the treatment of the exposed     pulp and whether the capping of a pulp represents the same outcome as the partial removal of     an additional 1-1.5 mm of the pulp tissue (partial pulpotomy).      Aim: The aim of the CAP-2 trial is in a randomised clinical trial to investigate the effect     of direct pulp capping versus partial pulpotomy in patients who, from the beginning, have     received either a final excavation or a stepwise excavation and where this intervention has     led to the exposure of a vital pulp and/or the patient has not gained relief from tooth pain     after excavation and placement of a temporary restoration.      Patients: Patients include consecutive patients with deep caries who have been participating     in the CAP-1 trial, where the pulp exposure to a bleeding pulp is present and/or pain relief     has not been obtained.      Design: The CAP-2 trial is a randomised patient- and observer-blinded multicenter trial, with     two parallel intervention groups. Patients who fulfill the inclusion criteria will be     centrally bloc-randomised in the Copenhagen Trial Unit, Copenhagen DK, and stratified by age     and pain. The allocation ratio is 1:1.      The Interventions and Products: Patients are allocated for direct pulp capping or partial     pulpotomy. The patients will not be informed about the results of the randomisation, i.e. the     type of intervention. In both groups the patient receives a calcium hydroxide seal covering     the exposure and a glass ionomer restoration. The final resin restoration is placed following     4 weeks.   "
179641|NCT00187863|"     The purpose of this study is to determine which factors are associated with the development     of chronic shoulder pain and disability.   "
179642|NCT00187876|"     The purpose of this study is to determine the efficacy of patellar tendon allografts that     have undergone the BioCleanse™ process.   "
179643|NCT00187889|"     Some women have chest pain even without having a blockage in one of the major blood vessels     that supplies blood to the heart. In many of these women the microscopic (small) blood     vessels in the heart do not function normally. This study seeks to determine if treatment     with eplerenone, a commercially available diuretic, can improve the function of these     microscopic blood vessels and, possibly, improve the chest pain.   "
179644|NCT00187902|"     Julius Schachter, PhD, from the Department of Laboratory Medicine at UCSF, and Jeffrey     Klausner, MD, from the Department of Public Health, are conducting a study to evaluate a type     of test (nucleic acid amplification test) for the detection of two sexually transmitted     diseases, Chlamydia trachomatis and Neisseria gonorrhoeae, in men who have sex with men     (MSM), using urine samples and swabs taken from the throat (pharynx), tip of penis (glans),     and rectum. The use of nucleic acid amplification tests on these swabs is experimental, which     means that the use of the tests for this purpose have not been approved by the Food & Drug     Administration.   "
179645|NCT00187915|"     This study is a prospective interventional trial of de novo renal transplant recipients,     aiming to validate a strategy which combines the use of early post transplant MPA AUC     sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a     clinically applicable fashion.   "
179646|NCT00187928|"     The purpose of this study is to determine if a drug called topiramate is safe and effective     as an add-on therapy in the treatment of Obsessive-Compulsive Disorder (OCD). Topiramate is     an investigational drug for OCD, which means it has not been approved by the U.S. Food and     Drug Administration (FDA). Topiramate has been approved as an add-on therapy for adults and     children with partial onset seizures or generalized tonic-clonic seizures, and for patients 2     years of age and older with a severe form of epilepsy called Lennox-Gastaut Syndrome.      Up to 96 subjects will be enrolled in this study. This study consists of three phases:     Washout/Screening Phase, Double-Blind Phase, and Taper Phase. The total expected length of     your participation in the study is approximately four months.   "
179647|NCT00187941|"     Individuals absorb Cellcept (MMF/Mycophenolate Mofetil) at different rates and it is     difficult to determine an individuals level of Mycophenolate Mofetil (MMF, trade name     Cellcept)from a single measurement. We will enroll 20 subjects. Plasma samples to be     collected pre-MMF dose (trough level) and at 30 and 120 min after the morning dose of     MMF.This will be done weekly for the first month and then monthly for the next 6 mths. We     hope to use a calculation of the subjects total MMF level during the first month to set a     trough target level to use during the next 6 months.   "
179648|NCT00187954|"     The purposes of this study are:        -  To correlate the severity of retinal arteriolar narrowing and other microvascular          changes, as determined from retinal photographs and video imaging, to measures of          coronary microvascular function in women evaluated for chest pain.        -  To evaluate measures of vascular compliance with applanation tonometry and          photoplethysmography using a nasal alar probe.   "
179649|NCT00187967|"     Blood activation induced by cardiopulmonary bypass may compromise the postoperative outcome.     The goal of this study is to compare blood activation induced by cardiopulmonary bypass     performed with centrifugal pump or roller pump in patients undergoing coronary artery     surgery.   "
179687|NCT00188461|"     Hypothesis: Does a 50% reduction in radiation in dose significantly affect the diagnostic     quality of chest CT   "
179662|NCT00188136|"     Karyotype is a major prognostic risk factor in patients with acute myeloid leukemia (AML)     translating into unfavourable outcome in case of poor-risk cytogenetic aberrations. Several     studies have shown that allogeneic hematopoietic stem cell transplantation (HSCT) after     myeloablative conditioning rather than autologous HSCT or consolidation chemotherapy result     in long-term disease control in this group of patients when achieving a first complete     remission. Nevertheless, the complete remission rate achievable is significantly lower than     in patients with a more favourable risk profile. In fact, only the minority of AML patients     with poor-risk cytogenetics, although having a suitable donor, proceed to HSCT due to     refractory disease or infectious complications during induction chemotherapy (IC). Further,     new data show that the course of therapy can be estimated as early as two weeks after the     initiation of the first course of IC with patients presenting with more than 10 % marrow     blasts doing significantly worse than those with a better clearance of blasts. As a result,     the chance to obtain a durable remission is considerably low and most patients with bad-risk     cytogenetics or failure to achieve blast clearance do not proceed to an allogeneic approach.     Together these data indicate that early treatment intensification is warranted in order to     provide the potential curative benefit of allogeneic HSCT to the majority of high-risk AML     patients.      We have shown that reduced-intensity conditioning (RIC) followed by allogeneic PBSC applied     during aplasia after the first cycle of IC in newly-diagnosed high-risk AML patients is     feasible and can result in a sustained disease control. These data prompted us to further     evaluate in a prospective trial an early up-front HSCT in patients with newly-diagnosed     high-risk AML defined by karyotype and insufficient blast clearance after the first cycle of     IC.      The goal was to provide an allogeneic HSCT as early as possible after diagnosis in AML     patients.   "
179651|NCT00187993|"     Hypopituitary adults with all the hormonal deficiencies are well subsituted excepted for the     growth hormone (GH) and died earlier than the rest of the population. GH deficiency involves     a fat mass increase with regard to lean mass, an atherogenic lipidic profile and     participating to osteopenia mechanism and decrease the life quality. All these dysfunctions     are partially or totally corrected by the GH prescription with patient deficient since     adulthood.      However, for patients deficient since childhood, no study have demonstrated that GH treatment     during childhood present these same benefit when they are treated during adulthood.      Primary objective of this study is to examine that fat mass significantly decrease due to GH     treatment in adulthood for patient GH deficient since childhood, treated by GH during     childhood but stopped since the end of adolescence.      We compare the body composition and others energetic metabolism parameters in two patient     groups, one treated by GH during 18 months, and the other with no treatment. Body composition     and bone density are measured by pletysmography (DEXA). Metabolic parameters are : energetic     balance (energy intake evaluation by questionnaire, energetic expenditure evaluated by doubly     labelled water) and biologic parameters (lipidic profile, thyroid hormones).      This study will evaluate if the GH treatment of young GH deficient adults since childhood can     be a benefit for body composition, lipidic profile and bone density.   "
179652|NCT00188006|"     The impact of the postoperative inflammatory response on the central nervous system after     cardiac surgery is uncertain.      The goal of this study was to evaluate the role of complement activation on cellular brain     injury and neurological functioning in patients undergoing coronary artery surgery. In     addition, the effect of complement activation on the cerebral vasomotricity was assessed.      Because receptors to activated complement are present on astrocytes, the heparin-coated     cardiopulmonary bypass that reduces complement activation should minimize these postoperative     neurological adverse events. Heparin-coating might also influence blood flow velocity in     cerebral arteries postoperatively if complement activation mediates cardiopulmonary bypass     induced cerebral vasomotor dysfunction.   "
179653|NCT00188019|"     Hereditary paraganglioma -due to SDH (SDHD, SDHB, SDHC) germline mutations- causes     paragangliomas and pheochromocytomas. Presymptomatic genetic testing should be offered to all     first-degree relatives if an SDH mutation is detected in an index case with paraganglioma or     pheochromocytoma. The main objective of our national clinical research project is to test     different screening methods to detect presymptomatic tumors in order to establish guidelines     for the work-up and the follow-up of SDH mutation carriers.   "
179654|NCT00188032|"     Aims: 1) To evaluate the effectiveness of two interventions aimed at improving the management     of patients with suspected pulmonary embolism: Written guidelines and Computer-Assisted     Decision Support (CADS). 2) To evaluate the impact of electronic reminders on the     appropriateness of the treatment of patients with suspected PE      Design: Pragmatic, unblinded, cluster randomised controlled study.      Setting: 20 French Emergency Departments      Patients: Out patients suspected of having pulmonary embolism      Methods: Emergency physicians will prospectively complete a standardized electronic form on     Personal Data Assistant (PDA), including patients' characteristics, the clinical probability     if assessed, the diagnostic tests performed, the treatments initiated and the final     diagnostic and therapeutic decisions. Patients will be interviewed at the end of a 3-month     follow-up period using a standardized questionnaire.      The reference rate of appropriateness of the diagnostic management before intervention will     be assessed in each centre. At the end of this preliminary period, the centres will be     randomized in two fold two groups according to a factorial design with stratification on     their reference level of appropriateness. Half of the centres will have written guidelines     and half a Computer-Assisted Decision Support for the diagnosis of PE on the PDA. In each of     these two main groups, half of the centres will have electronic reminders on their PDA     concerning the treatment of PE.      Judgment criteria      Main : Rate of strategies considered as validated according to the results of the systematic     review and meta-analysis.3      Secondary judgment criteria (diagnosis):        -  Rate of strategies considered as validated or acceptable according to the opinion of          international advisors.        -  Rate of thromboembolic-events during a 3-month follow-up period in patients for whom          pulmonary embolism will be ruled out        -  Costs of the diagnostic management      Secondary judgment criteria (treatment):        -  Delay between Emergency Department admission and the first dose of antithrombotic          treatment in patients with high clinical probability of PE according to the Revised          Geneva Score        -  Rate of inappropriate treatment according to international recommendations for patients          with confirmed PE.      Number of patients: By estimating that the rate of appropriateness would be 55% in the     written guidelines group, 1331 patients are necessary to highlight an absolute superiority     of 15% in the CADS group (rate of conformity of 70%).      The number of patients will be adjusted at the end of the preliminary period according to the     level of appropriateness before interventions considering that it will improve less than 5%     in the written guidelines group.   "
179655|NCT00188045|"     The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic     administration (2 month) of spironolactone or propranolol, alone or in association in     alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day,     propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and     splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements     before and after 2 month of treatment.   "
179656|NCT00188058|"     The aim of this multicenter randomized controlled trial is to compare the impact on mortality     of patients mechanically ventilated for acute lung injury or acute respiratory distress     syndrome of two strategies for setting end-expiratory pressure.   "
179657|NCT00188071|"     -  To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the          combination of these two analgesics        -  each treatment beeing allocated by randomization   "
179658|NCT00188084|"     Adult acute lymphoblastic leukemia treatment approaches relie on risk stratification,     including cytogenetics. We want to study at diagnosis several blast cells parameters on     frozen samples of GRAALL protocols enrolled patients:        1. A CD45-DNA double staining analysed by flow cytometry will allow mesurement for each          blastic clone of DNA ploidy, percentage of cells in S-phase, CD45 fluorescence index.        2. The proteine P16 metabolic way, involved in cell cycle regulation, will be studied by          Western Blot analysis.      The comparison between these parameters, and main haematological data, will be followed by a     prognostic analysis, based on blast corticosensibility in vivo, chimiosensibility, complete     remission, and survival.      Combination of the studied parameters will allow to appreciate a clonal diversity. This will     help to predict, at diagnosis, high probability of resistance to treatment.   "
179659|NCT00188097|"     The aim of the study was to determine the independent predictors of variceal bleeding and     control of bleeding in cirrhosis as no scientific assessment have been perfomed until now   "
179660|NCT00188110|"     The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based     on the colon distension by a high volume of warm water and a multidetector CT acquisition     after IV (intravenous) contrast, allowing image analysis including the wall thickness and     enhancement, the pericolic adjacent spaces and the entire abdomen.      The goal of the study is the evaluation of its performances for the diagnosis of colon     tumors.   "
179661|NCT00188123|"     The hypothesis is that single-shot imaging of myocardial infarction is possible in atrial     fibrillation using MRI late enhancement technique   "
179665|NCT00188175|"     Intensity-modulated radiation therapy may make wound healing problems less likely by     1)precisely shaping the region of high radiation dose to the shape of the tissue which     harbours tumour cells, and 2) precisely shaping the regions of low radiation dose to the     shapes of the normal tissues which are more sensitive to radiation effects.   "
179666|NCT00188188|"     Systemic Lupus Erythematosus is a relatively common autoimmune disease that affects mainly     women.Cardiovascular disease as a result of accelerated atherosclerosis is a major cause of     mortality and morbidity in SLE.Previous research has shown that 35-40% of patients with SLE     have abnormalities of myocardial perfusion even when they have no coronary stenoses on     coronary angiography. The reason for these frequent perfusion abnormalities in the absence of     angiographically significant CAD remains uncertain, but could conceivably result from     endothelial dysfunction. In SLE, coronary endothelial dysfunction could result from the     inflammatory process involved in the SLE disease itself, a finding that could explain the     correlation between disease activity and the development of CAD in these patients.As such     endothelial dysfunction may account for accelerated atherosclerosis and cardiac perfusion     defects (without angiographically significant coronary lesions). We propose to first evaluate     whether endothelial dysfunction occurs in these patients and is more frequent in patients     with myocardial perfusion abnormalities. Endothelial function will be assessed by measuring     flow-mediated brachial artery dilatation. In the 250 patients included in the study we will     correlate endothelial function and myocardial perfusion abnormalities to SLE disease     activity, to its treatment and to the presence of CAD risk factors In a subgroup of patients     (estimated 5 patients) in whom it is clinically indicated, coronary angiography will be     performed in order to assess the presence of significant coronary stenoses (>50%),coronary     artery reserve and coronary endothelial dysfunction. We will then attempt to reverse     abnormalities in endothelial function and myocardial perfusion by therapy with an ACE     inhibitor(Quinapril).Patients with myocardial perfusion abnormalities will be randomised to     receive Medication A(oral Quinapril or Placebo) for 8 weeks, will have all baseline     investigations repeated and then will switch over and receive medication B(Quinapril or     placebo) for a further 8 weeks followed by repeat investigations.   "
179667|NCT00188201|"     The estimated global prevalence of hepatitis C (HCV) infection is approximately 3% (170     million individuals). In Canada there are an estimated 240,000 people infected with HCV. The     current study addresses the hypothesis that neurocognitive and neurochemical abnormalities     may occur in individuals with HCV-infection who do not have liver cirrhosis or vasculitic     neuropathy, and this may result from a direct effect of HCV on the Central Nervous System     (CNS). The purpose of this study is to assess whether infection with the Hepatitis-C virus is     associated with changes in thinking skills and brain chemistry, in patients who do not have     liver cirrhosis. In addition, we are examining whether such changes in thinking skills and     brain chemistry are reversed by antiviral treatment. We are also studying whether factors     such as fatigue and depression have an effect on thinking skills in people with Hepatitis-C.     In order to take into account the impact of having viral hepatitis, we will be comparing the     results of the Hepatitis-C group to the results of a group of patients with Hepatitis-B, and     to a group of individuals who do not have Hepatitis.   "
179668|NCT00188214|"     Cancer of the lung is treated with surgery, radiation or chemotherapy, depending on the stage     or extent of the disease. Some patients are treated with chemotherapy and/or radiation     therapy before surgery to improve the results of surgery. After these treatments, we do not     know whether the residual tumour tissue is still alive or dead, which is why some physicians     feel that surgery is required to remove it.      This study is designed to assess if computed tomography (CT, CAT-scan) enhanced with     intravenous contrast agent (dye) can characterize a lung cancer, and say whether it is alive     or dead. The researchers hope that in the future such a contrast-enhanced CAT-scan will make     surgery less often necessary or improve the results of chemotherapy and/or radiation given     before surgery.   "
179669|NCT00188227|"     The purpose of this study is to investigate and compare the effects of three different     methods for reducing pain and anxiety in adult patients undergoing puncture of the bone     marrow. The investigated methods are: cognitive behavioural technique, administration of a     sedative drug(Midazolam) and administration of an analgetic drug (Piritramid)prior to the     procedure. Additionally, there are two comparison groups in which the patients receive either     placebo treatment or no treatment at all.   "
179688|NCT00188474|"     There is much data in the literature regarding optimal treatment approaches for malignant     pleural effusions as assessed by patient outcomes. However, data on quality of life and     satisfaction with treatment from the patient's perspective is not available.   "
179689|NCT00188487|"     Asthma is a disease of small airways. Affected areas have reduced lung ventilation causing     reflex vasoconstriction. MR perfusion imaging of the lungs is a sensitive method of imaging     zonal lung perfusion.   "
179690|NCT00188500|"     The purpose of this study is to determine whether patients with uncontrolled epilepsy can     follow a low carbohydrate diet long-term and if so, how will that diet affect their seizures   "
179702|NCT00188656|"     This study is conducting a comparison of chest x-ray (CXR) and minimum dose thoracic CT     (MnDCT) in the detection of lung nodules (metastases) in patients with head and neck     carcinoma.   "
179670|NCT00188240|"     The literature suggests that there may be an association between hepatitis C and type 2     diabetes mellitus independent of the presence of cirrhosis, the likely mechanism for which is     insulin resistance. The prevalence of insulin resistance in patients with hepatitis C is     unknown. Furthermore, there are no studies that indicate an increased prevalence of insulin     resistance in patients with hepatitis C compared to other etiologies of liver disease. The     role that hepatitis C may have in the development of insulin resistance is unclear. The     effect of antiviral therapy for hepatitis C virus on insulin resistance has not been     addressed. The long-term consequence of insulin resistance is type 2 diabetes mellitus. There     is significant morbidity and mortality from type 2 diabetes mellitus in the general     population, and similar complications would be expected in patients with hepatitis C and     insulin resistance particularly if they develop type 2 diabetes mellitus.      Our hypothesis: The prevalence of insulin resistance is increased in patients with chronic     hepatitis C compared to chronic hepatitis B. Secondarily, insulin resistance when present in     patients with chronic hepatitis C improves with successful antiviral therapy.      This study has two phases. The first phase of our study will be to estimate the prevalence of     insulin resistance in individuals with chronic hepatitis C without cirrhosis compared to     patients with chronic hepatitis B without cirrhosis. The second phase of the study will be     restricted to those patients with hepatitis C found to be insulin resistant from phase 1, in     the absence of known risk factors for insulin resistance (cirrhosis, diabetes). The effect on     insulin resistance of anti-viral therapy to eradicate hepatitis C will be assessed.   "
179705|NCT00188695|"     The purpose of this study is to test whether or not a new contrast agent called Combidex, a     contrast agent formulated from ultra-small superparamagnetic iron oxide (USPIO) improves the     ability of Magnetic Resonance Imaging (MRI) to see lymph nodes in the pelvis. It might also     help doctors tell whether or not cancer has spread to these lymph nodes. It might allow     radiotherapy to be delivered more accurately.   "
179671|NCT00188253|"     The standard treatment for nasopharyngeal cancer involves either radiation alone or radiation     plus chemotherapy. Before the start of treatment,patients require an imaging scan to assess     the extent of disease. The most commonly used test is a magnetic resonance imaging (MRI)     scan.      The goal of the study is to examine the value of a new imaging technology that has recently     become available at the University Health Network Hospitals called Positron Emission     Tomography scanning (PET). PET scanning involves the injecting a small amount of a drug     through a vein in the arm called 18-fluorodeoxyglucose (18FDG). This drug is special in that     it is radioactive and will be detected by the PET machine. Cancer cells are believed to be     more active than normal cells and have a high rate of metabolism. Therefore, cancer cells are     thought to take up glucose (a kind of sugar) faster than normal cells in the body. Because     18FDG is a modified type of glucose, it is also taken up by cancer cells. Special imaging     cameras will be able to visualize the areas of uptake and reveal sites of cancer involvement.     The main goal of this study is to evaluate whteher the scan is able to detect the presence of     nasopharyngeal carcinoma (NPC) both before and after treatment and to specifically compare it     to findings on magnetic resonance imaging scans (MRI).      In addition to doing the PET scans, we are asking patients to have blood samples drawn     throughout their treatment and follow-up, for a research test called Epstein Barr virus (EBV)     DNA levels. The Epstein Barr virus is thought to have a role in the development of     nasopharyngeal cancer, and many patients with nasopharyngeal carcinoma are found to have high     levels of EBV DNA levels in their blood. The second goal of this study is to evaluate whether     changes in EBV DNA levels are associated with the treatment and the disease course in     nasopharyngeal cancer, and whether they help to predict any changes in the cancer. This part     of the study involves the sampling of a small amount of venous blood at a time prior to the     beginning of therapy and at regular intervals following treatment.   "
179672|NCT00188266|"     In 1991, the South West Oncology Group (SWOG) conducted a randomized study of adjuvant     chemotherapy (5-fluorouracil and folinic acid) with concurrent radiation (4500 cGy/25     fractions) versus surgery alone for patients with completely resected gastric carcinoma.      This landmark study showed the benefit of adjuvant treatment for gastric cancer and radically     changed the treatment of this disease. However, the resulting standard treatment has severe     acute toxicity, and despite this advance, 50% of patients still die of gastric cancer. The     investigators hope to develop a modified protocol using active chemotherapy agents, but with     reduced acute toxicity. Such an approach could ultimately be studied against the current SWOG     approach to determine whether or not the addition of cisplatinum improves efficacy.      Patients who decide to participate in the study will receive a chemotherapy drug called     5-Fluorouracil (5FU)through an intravenous catheter continuously over 12 weeks. Patients will     not be admitted to hospital to receive the chemotherapy but will need to wear a waist pack to     carry a small pump that will deliver the medication. They will however need to make regular     visits to have their medication bags changed. Patients will also receive Cisplatin     intravenously every 2 weeks for 4 doses. In addition, patients will also receive radiation to     their stomach, lymph nodes, and the area where they had their surgery. This study also     comprise of a questionnaire for us to see how patient's cancer and treatment is affecting     their quality of life. Patients will have regular follow-up by their physicians.   "
179673|NCT00188279|"     This study is designed to help decide whether a CAT scan performed at a very low dose of     radiation (Minimum dose CT scan) is better than a Chest X-Ray in detecting recurrence of lung     cancer in the chest (after surgery).   "
179674|NCT00188292|"     Cancer of the anus occurs at very high rates in young men with HIV and is caused by a virus     called human papillomavirus (HPV). Anal cancer has increased during the HIV epidemic despite     effective therapies for HIV. Unfortunately, anal cancer presents at a late stage because     there is no screening program to find it at an early stage.      Rates of other cancers such as cervical cancer have been reduced through the use of Pap     smears. The researchers' plan is to do the same type of screening for anal cancer as has been     done for cervical cancer. If abnormalities are found then treatment can be started. The     researchers hope that this approach will help to prevent anal cancer.      Testing for HPV will also be done to see if this helps to detect early cancer and to see how     accurate different tests, pathologists and clinical examiners are at detecting and agreeing     on any abnormalities.      The main outcome is the presence of any pre-cancerous or early cancer changes as determined     by high resolution anoscopy (HRA). HRA involves looking through a microscope into the anus     and this allows very tiny changes to be identified. Pieces of tissue can then be taken to     make a definite diagnosis.   "
179691|NCT00188513|"     There are several different treatment schedules being used across the world for treatment of     prostate cancer with radiation therapy. In order to determine the best radiation treatment     for this disease, a study is being performed by the doctors at the Princess Margaret     Hospital. This study will try to measure the effectiveness and side effects of an increased     dose of radiation to the prostate that is also given over a shorter number of weeks than is     usually done. In order to try to reduce the possible side effects of the radiation therapy     the treatment will be given using special techniques to shield as much of your normal body     tissues as possible. This method of treatment is called conformal intensity modulated     radiation therapy, or IMRT.   "
179692|NCT00188526|"     This study is a comparison of core needle biopsy with fine needle aspiration biopsy in the     evaluation of lung nodules.   "
180051|NCT00193167|"     This non-randomized phase II study is designed to assess the response rate and toxicity of     weekly topotecan as second-line treatment in patients with relapsed or refractory metastatic     colorectal cancer.   "
179675|NCT00188305|"     Having at least one first-degree relative (FDR) with colon cancer increases an individual's     risk of developing the disease. Many relatives of cancer patients are ineligible for genetic     testing and, therefore, do not receive information from a healthcare provider about the     disease. Providing relatives of cancer patients with information about their risk of     developing colon cancer, screening information, and other colon-related health information,     may increase knowledge and screening compliance as has been shown in relatives of breast     cancer patients. The primary aim of this study is to test the efficacy of two modes     (in-person vs. telephone) of providing a risk counseling and health promotion intervention     for relatives of cancer patients on measures of knowledge of colon cancer risk and     health-related factors, comprehension of risk, understanding of screening recommendations and     intent to adopt an appropriate screening regimen. Participants will be randomized into one of     three study arms (in-person, telephone, control). An assessment pre- and post- intervention     will be conducted. In addition, longer-term follow-ups will be carried out two months and one     year following the intervention to examine the sustainability of the intervention effect.   "
179706|NCT00188708|"     Prostate cancers, in common with many other tumours, are often hypoxic; that is, they have     low levels of oxygen. It is thought that tumour hypoxia may hasten the progression of cancers     and make them more resistant to treatment. One previous study has suggested that hormone     therapy, such as Casodex, may improve the prostate oxygen level. This study is designed to     test that finding.   "
179676|NCT00188318|"     This study is examining the effects of increasing the dose of radiation given to treat head     and neck cancer. Radiation doses to the primary cancer are higher than usually given; lymph     glands of the neck will also be treated at a lower dose. Surgery on the lymph glands my be     necessary in the future. Radiation treatments given in small fractions twice a day allows a     higher dose to be delivered than if the treatment was given once a day. This study will     enroll patients at three sequential increasing dose levels. Approximately 40 patients will be     enrolled at each dose level.   "
179677|NCT00188331|"     This is a prospective, longitudinal cohort study to evaluate fatigue and cognitive function     in patients with colorectal cancer (CRC) treated with chemotherapy, and in patients with the     same malignancy, that do not receive chemotherapy. A self-report questionnaire for fatigue     (the FACT-F), and validated tests of cognitive function, will be applied at predetermined     times before, during and after chemotherapy, to determine the incidence, severity and     duration of these symptoms. Comparisons will be made in changes in cognition for individuals,     as well as between the chemotherapy and the control group. Mechanisms that might lead to     fatigue and/or cognitive decline will be investigated.   "
179678|NCT00188344|"     The purpose of this study is to compare pneumatic dilatation and laparoscopic Heller myotomy     in patients with achalasia in order to learn which of these two treatments should be     recommended to patients in the future.   "
179679|NCT00188357|"     Several studies have shown that persons with systemic lupus erythematosus (SLE) have poor     general health and a higher risk of heart attack and bone loss (osteoporosis) compared to the     general population. Some of the risks associated with heart attacks and bone loss are     modifiable (can be changed). For example, high blood pressure, high cholesterol, smoking,     lack of exercise are risk factors associated with heart attacks that can be changed. Whereas,     age and a family history of heart attacks are risk factors that can not be changed.     Similarly, a diet low in calcium, smoking and lack of exercise are modifiable risk factors     associated with osteoporosis; while, family history and age are not modifiable. The Health     Improvement and Prevention Program (HIPP) in Systemic Lupus Erythematosus was developed to     increase the general health in persons who have lupus and to help reduce the risk of heart     attacks and bone loss. This intervention program gives comprehensive      information about lupus and provides tools on how to live better with lupus. The program     includes visits with a nurse case manager who will work in close collaboration with the lupus     team. She will work on an individual basis with each participant to develop a mutually agreed     upon personalized care plan aimed at improving general health, coping skills and heart and     bone health.      HIPP STUDY (Health Improvement And Prevention Program)      Dr Paul Fortin Principal Investigator      Primary and Secondary objectives:        -  To improve health status, decrease cardiovascular risk and improve endothelial function          in persons with SLE compared to usual care.        -  To improve bone health behaviors and prevent decrease in bone mineral density.        -  To improve adherence to treatments.        -  To help persons with Lupus move toward wellness by increasing knowledge.        -  To show that HIPP is cost effective and could become standard care.      Duration: 2 years      Enrollment 240 patients      Study Design:        -  Randomized prospective study of HIPP compared to usual care, patients will be crossed          over at Mth 12. Data collected for 24 mths.        -  Demographic, health status, cost, SLE knowledge, coping, cardiovascular and osteoporosis          information will be collected.        -  All patients will undergo clinical evaluation to measure disease activity, BMD (every 2          years) and Flow mediated Doppler (every year)        -  HIPP now patients will attend 4 knowledge sessions, covering SLE, coping with chronic          disease, cardiovascular disease in Lupus, bone health in Lupus.        -  HIPP now patients will be followed by nurse coordinator and receive an individualized          risk assessment, telephone follow-up, smoking cessation counseling. For those found at          risk stress reduction (Mindfulness Based Stress Reduction) and or bone health program          will be provided. Hipp now patients will attend Cardiac Rehabilitation Program at TWH.          All HIPP now pts will attend the Cardiac Rehabilitation program at the TWH.      Inclusion Criteria:      SLE according to ACR, >18 yr, Female, must read and write french or english      Exclusion Criteria:      MI, TIA, CVA, Other arterial occlusion, PVD, Osteoporosis as defined by BMD, Pregnant now,     active cancer      For further information contact Study Coordinator Anne Cymet Tel # 13-2895 Pager 416-664-   "
179680|NCT00188370|"     A group of researchers at the Ontario Cancer Institute/Princess Margaret Hospital have     discovered that a very specific form of cell death 'apoptosis' can be detected using     high-frequency ultrasound imaging. This type of cell death is recognized to occur in tumours     in response to various different chemotherapeutic drugs and in response to radiation therapy.     This group of researchers has confirmed that high-frequency ultrasound can detect apoptosis     in response to tumour treatments experimentally using cell culture and experimental animal     systems. The ultrasound approach is now being evaluated clinically in a 3-year clinical trial     enrolling a target of 200 patients including Hodgkin's disease and non-Hodgkin's disease     lymphoma patients, melanoma patients and patients with basal cell carcinoma. Our hope is to     be able to use this type of imaging system in the future to clinically monitor the effects of     therapy on tumours and rapidly detect tumours which are not responding so that changes in     therapy can be made much quicker than presently possible.   "
179681|NCT00188383|"     The primary aim is to determine whether perioperative NMDA-receptor antagonism has     differential effects on postoperative pain, hyperalgesia and morbidity in younger and older     patients. In order to achieve this aim, the researchers propose to conduct the first     randomized, double-blind placebo-controlled study designed to investigate age differences in     the effects of perioperative oral administration of an NMDA-receptor antagonist (amantadine)     in men undergoing radical prostatectomy. In addition, age differences in psychosocial factors     and the pharmacological properties of amantadine and morphine will be measured to control     for, and clarify, their contribution to the differences found.      The specific objectives of the study are to:        1. investigate the effects of perioperative NMDA receptor blockade on postoperative          hyperalgesia, pain and analgesic consumption in young and elderly men        2. assess age differences in the intensity and course of secondary hyperalgesia after          surgery   "
179682|NCT00188396|"     Objectives: This prospective investigation will compare premenopausal, perimenopausal and     postmenopausal women's response to antidepressant medication. The effects of the menstrual     cycle on the symptoms of depression and antidepressant response will also be examined.      Hypotheses: Premenopausal women will show a significantly better response to a selective     serotonin reuptake inhibitor (SSRI) than peri- or postmenopausal women. Premenopausal women     during lower estrogen phases of the menstrual cycle will complain of increased depressive     symptoms despite treatment. Perimenopausal and postmenopausal women with irregular periods     and generally low estrogen levels will show less symptom variability over time.      Method      Subjects: Eighty-four women (28 premenopausal, 28 perimenopausal, 28 postmenopausal) meeting     Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for     major depressive disorder will be enrolled in the study.      Procedure: All the subjects will be followed prospectively for 12 weeks and through 2     menstrual cycles while receiving treatment with a standard SSRI antidepressant agent. All     eligible women will have a structured clinical interview and will complete questionnaires     assessing their depressive symptoms. Blood samples will be collected to evaluate for     reproductive hormone levels during the late follicular, midluteal and late luteal phases of     the menstrual cycle for two consecutive cycles. Serum SSRI levels will also be collected at     these times. As the women in the perimenopausal and postmenopausal groups either have     irregular menstrual cycles or no longer cycle, they will have blood samples drawn at baseline     and on 6 other occasions.      Research Implications: As the majority of psychiatric medication is prescribed to women,     understanding the interplay between the menstrual cycle and antidepressant medication will     ultimately translate into more diverse and improved patient care. The proposed study is one     within a developing research program, which will in part be further guided by this study.   "
179683|NCT00188409|"     A CT scan is performed after a lung biopsy in order to detect a Pneumothorax. We postulate     that CT is more useful than chest radiography   "
179684|NCT00188422|"     The primary outcome of this study is the detection of lung metastases comparing Low dose CT     (LDCT) and Minimum dose CT (MnDCT) with CXR.      Hypothesis        1. LDCT and MnDCT have similar sensitivity for the detection of lung nodules (metastases).        2. MnDCT of the thorax detects a larger number of nodules (metastases) than CXR.   "
179685|NCT00188435|"     A comparison of chest x-ray (CXR) and Minimum dose CT (MnDCT) in the acutely ill patient. The     hypothesis is that MnDCT is more sensitive than CXR in the detection of acute findings in the     acutely ill patient.   "
179686|NCT00188448|"     Repeat MRI of the Superficial temporal Artery in 5 volunteers   "
179695|NCT00188565|"     Colorectal carcinoma is the third most common cause of death from cancer. Approximately, 30%     of colorectal carcinomas involve the rectum. Optimizing local control in the pelvis while     reducing treatment toxicity remains one of the principal goals of therapy for patients with     locally advanced rectal carcinoma. Treatment strategies that achieve this goal will have a     significant impact on our society.C linical trials have shown that this type of cancer is     less likely to come back if chemotherapy and radiotherapy are added to surgery. A combination     of all three types of therapy is now standard.      Celecoxib (Celebrex®) is a drug that lessens the action of an enzyme called cyclooxygenase-2     (COX-2) also known as a COX-2 inhibitor. It is an anti-inflammatory capsule (drug that     reduces irritation) that is commonly used to treat arthritis. It is not a chemotherapy drug.     Laboratory experiments have shown that such COX-2 inhibitors may increase the anti-cancer     effect of radiotherapy, without increasing radiation side effects. This has not yet been     confirmed in humans.The main purpose of this study is to confirm that celecoxib does not     increase the side effects when given with radiotherapy and chemotherapy for rectal cancer. We     shall also be looking at how effective the combination of radiotherapy, chemotherapy and     celecoxib is in shrinking rectal cancer.   "
179696|NCT00188578|"     Standard treatment for gynecological cancer is radiation therapy in two phases; whole pelvic     radiation and then an internal radiation boost, also called a brachytherapy boost, to treat     any remaining tumour.      The purpose of this study is to test an alternative radiation boost treatment called     conformal intensity modulated radiation therapy or IMRT. Currently, we do not have complete     information on the overall effectiveness of IMRT compared to brachytherapy or conformal     radiotherapy. We know that IMRT allows the radiation beams to be more accurately focused on     the tumor, thereby sparing more normal tissue from radiation damage and lowering risks of     side effects. We are investigating the extent to which IMRT can be used to protect normal     tissues in patients with cervix, uterine or vaginal cancer from the radiation beams and how     much the side effects of radiation are reduced.   "
179697|NCT00188591|"     The proposed pilot study attempts to investigate the feasibility of Optical Spectroscopy (OS)     as a method to quantify breast tissue composition and density in adolescent females. Our     goals include: to assess whether adolescent girls can be instructed to assist with the OS     measurement procedure and to determine the OS technique's ability to show breast tissue     composition and density in adolescent breast tissue.   "
179698|NCT00188604|"     The primary objective of this study to assess the effectiveness of selenium compared to     placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are     to assess the impact of selenium on patient's quality of life and to assess the incidence of     adverse effects of selenium therapy.   "
179699|NCT00188617|"     ELIGIBILITY        -  Non-small cell lung cancer Clinical Stage 1A (T1N0M0 a tumor that is 3 cm or less in          greatest dimension, surrounded by lung or visceral pleura, and without bronchoscopic          evidence of invasion more proximal than the lobar bronchus (i.e., not in the main          bronchus)* or 1B (T2N0M0 a tumor with any of the following features of size or extent:          More than 3 cm in greatest dimension. Involves the main bronchus, 2 cm or more distal to          the carina. Invades the visceral pleura. Associated with atelectasis or obstructive          pneumonitis that extends to the hilar region but does not involve the entire lung).        -  Must be deemed appropriate surgical candidate        -  ECOG performance status £ 2        -  Age ³ 18 years        -  No prior chemotherapy, radiotherapy or EGFR inhibitors      PRE-TREATMENT INVESTIGATIONS        -  History, physical examination, hematology, biochemistry, toxicity/baseline symptoms:          within 7 days of registration        -  Radiology: CT chest within 7 days of registration        -  Tumor biopsy prior to treatment      TREATMENT        -  Gefitinib 250 mg will be administered orally daily x 28 days      EVALUATIONS ON TREATMENT        -  Physical examination (vital signs, weight, ECOG performance status) weekly x 4        -  Hematology (CBC, differential): Day 1,15, 29        -  Biochemistry (creatinine, electrolytes, bilirubin, alkaline phosphatase, AST/ALT,          protein): Day 1,15, 29        -  Radiology: CT at baseline and after day 28        -  Toxicity evaluation: continuous      DURATION OF TREATMENT        -  Treatment is to be discontinued in cases of serious or unacceptable toxicity, or by          patient or physician request        -  Otherwise duration of therapy will be a maximum of 28 days   "
179700|NCT00188630|"     Cardiac surgery improves the survival and quality of life of people with heart disease.     Nonetheless, several complications continue to adversely affect outcomes following cardiac     surgery. Kidney failure is a particularly important complication that is associated with     increased death and duration of hospitalization. The most severe form of postoperative kidney     failure, the need for dialysis, is uncommon at present. It is however likely to increase in     the future. Patients undergoing cardiac surgery are getting older with more heart failure,     diabetes, high blood pressure, and pre-existing kidney disease. Given that these are risk     factors for postoperative kidney injury, dialysis rates will likely increase. Although     multiple therapies have been tested, none have prevented postoperative kidney failure.     N-acetylcysteine (NAC) is a drug that is commonly used to treat Tylenol overdoses. Over the     past 2 years, it has also been used to prevent kidney damage after exposure to IV dye. There     is good evidence that NAC will reduce kidney damage after IV dye exposure. There are strong     reasons to believe that NAC may also prevent postoperative kidney failure. NAC is safe. Its     major side-effects are allergic reactions, but serious reactions are rare. Since dialysis is     uncommon, large studies are needed to determine if NAC prevents postoperative dialysis. In     this situation, a pilot study is needed to determine if such a large trial is feasible. This     proposal describes a pilot study. We will determine NAC's effects on creatinine clearance, a     measure of how well the kidney works. Reduced creatinine clearance is closely related to     dialysis and death after cardiac surgery. This biological marker allows us to determine NAC's     effects on kidney function with a reduced sample size. If NAC improves creatinine clearance,     it would suggest that NAC prevents postoperative dialysis, and would justify a larger study.     A pilot study will help us estimate how many patients will be willing to participate in     similar studies, vital for planning a future large study. Finally, our results will estimate     how well NAC will reduce dialysis rates. This is needed for calculating the sample size for     future studies.The study design is a randomized, double-blinded, placebo-controlled clinical     trial among patients undergoing bypass surgery or heart valve surgery at the Toronto General     Hospital (Toronto, ON). We will recruit 176 people who are at increased risk for developing     kidney failure after surgery. Participants will receive either NAC or sugar solution during     their operation. If participants have returned home within a month of surgery, they will be     contacted at home on the 30th day after surgery to determine if they had any kidney-related     problems since returning home. All participants will return to the Toronto General Hospital     (TGH) during the 8th week after surgery for creatinine blood test and weight.   "
179701|NCT00188643|"     The primary objective of this study is to assess the efficacy of venlafaxine XR and     lamotrigine when each is added to mood stabilizer therapy in patients with acute depressive     episodes of bipolar I or Bipolar II disorder. Efficacy of therapy will be evaluated using     improvements in clinical symptomatology after 8 weeks of treatment as measured by reductions     on the Hamilton Depression Rating Scale (HDRS-29) total score >50% from baseline. We also     would like to assess the efficacy of venlafaxine XR and lamotrigine when each is added to     mood stabilizer therapy in improving clinical symptomatology after 8 weeks of therapy as well     as to evaluate the side effect profile, safety and tolerability of venlafaxine XR and     lamotrigine.   "
179703|NCT00188669|"     An estimated 20 - 45 % of women treated with breast conserving treatment experience chronic     pain in the treated breast. The aetiology of this is poorly understood. Some of these women     have signs of chronic radiation mastitis. There is no accepted treatment for this condition.     The combination of pentoxifylline and vitamin E has been shown to be effective in reversing     radiation fibrosis in this region. Many of these patients have had a benefit in pain response     in a time period of a few benefits. This study is a phase II study of these drugs for a 6     month trial period to assess the effect on chronic breast pain in breast cancer patients who     are 3 months to 3 years post radiation treatment.   "
179704|NCT00188682|"     The purpose of this study is to learn more about the application of transillumination     measurements in the determination of breast cancer risk. The goal is to demonstrate a     correlation between non-invasive optical transillumination spectroscopy and parenchymal     density pattern.   "
179707|NCT00188721|"     This study aims to evaluate if a light based technique, called Transillumination Breast     Spectroscopy (TIBS), can be used to construct a non-invasive breast cancer risk predictor     which provides a better odds ratio than mammographic parenchymal density.   "
179708|NCT00188734|"     Early detection of lung cancer may improve treatment outcomes. Risk factors have been     identified, suggesting a population which might benefit from regular screening. Lung cancer     screening using low-dose computed tomography (LDCT) has experienced a recent renaissance with     reported sensitivity for detection of lung cancer of 2.7% in high-risk populations. The     purpose of this study is to evaluate the utility of LCDT for the early diagnosis of lung     cancer in Ontario.   "
179709|NCT00188747|"     Open-heart surgery frequently results in abnormal clotting, which in turn results in     excessive blood loss and the need for transfusion of multiple blood products to patients and     leads to adverse outcomes. Prompt identification of any clotting abnormalities after cardiac     surgery reduces blood loss and blood product transfusion and may improve outcomes. Currently,     however, this monitoring is dependent on standard laboratory-based tests of clotting that     have a long turnaround time (30-45 min) and do not measure some important aspect of clotting.     There are now other monitoring options that are carried out at patients’ bedside, providing     results more quickly than standard laboratory tests (within 2-5 minutes for some), and     measure more aspects of clotting, providing more information on possible causes of any     abnormalities. In this study, we will compare the cost-effectiveness of two of these newer     monitoring techniques with standard laboratory-based tests by assigning 150 patients who will     be undergoing open-heart surgery to one of the three monitoring techniques (50 patients will     be assigned by chance to each group). In each group, an explicit algorithm based on the     monitoring technique of that group will be used to guide all transfusion decisions.     Between-group differences in number of units of blood products transfused (primary outcome),     amount of blood loss, rate of adverse events, and cost of monitoring will be measured. The     objective of the study is to determine which of the three methods is most cost-effective in     terms of these outcomes.   "
179710|NCT00188760|"     The purpose of this study is to test the ability of a technique called Transillumination     Breast Spectroscopy (TIBS) to monitor an individual's breast density changes over time.   "
179711|NCT00188773|"     A prolonged elevation of plasma free fatty acids (FFA) impairs glucose stimulated insulin     secretion. The concept of fatty acid impairment of glucose stimulated insulin secretion     (lipotoxicity) has now been well accepted. Increased free fatty acid flux from adipose tissue     to non-adipose tissue, resulting from abnormalities of fat metabolism, participates in and     amplifies many of the metabolic derangements that are characteristic of insulin resistance     syndrome and type 2 diabetes.      Lipotoxicity is also likely to play an important role in the progression from normal glucose     tolerance to fasting hyperglycemia and conversion to frank type 2 diabetes in insulin     resistant individuals. This area of research is now focused on determining the mechanisms     whereby FFAs impair b-cell function. There is some evidence to suggest that lipotoxicity     could be mediated through induction of reactive oxygen species (ROS). N-acetylcysteine (NAC)     is a known potent antioxidant and has been used experimentally in a number of medical     conditions in humans for its protective antioxidant effects. The investigators now plan to     administer NAC orally to humans for 48 hours to examine the effects of antioxidant therapy in     ameliorating the deleterious effects of FFAs on pancreatic beta cell function. NAC is     currently approved for the treatment of acetaminophen overdose and is also used as a     mucolytic agent. The investigators are now using NAC as an antioxidant to determine whether     it protects the pancreatic beta cell against the toxic effects of FFAs, as outlined in the     detailed study protocol. This is a proof-of-principle study and is not designed to develop     n-acetylcysteine for therapeutic use.   "
179712|NCT00188786|"     Conformal dose escalated radiation therapy (CRT) is standard treatment for patients with low     and intermediate risk prostate cancer. CRT requires accurate daily localization of the     prostate prior to treatment to correct for prostate motion and set-up errors. Cone beam     computed tomography (CT) can accurately localize fiducial markers within the prostate. Cone     Beam CT also provides important information on daily position of organs within the pelvis.     This study aims to assess the feasibility of cone beam CT for daily localization of the     prostate as well as document changes in size and location of pelvic organs during an entire     course of CRT.   "
179724|NCT00196833|"     Women who were diagnosed with breast cancer during their pregnancy may be registered in this     trial.      Data is collected on the foetal outcome 4 weeks after delivery, maternal outcome of pregnancy     as well as the breast cancer therapy applied (treatment, response to chemotherapy, type of     surgery), diagnostic procedures applied (palpation, US, mammogram) and the outcome of mother     and child after 5 years of therapy.   "
179713|NCT00188799|"     Conformal dose escalated radiotherapy was adopted as the standard treatment technique at PMH     for intermediate risk patients with localised disease in 1997. This technique provides a much     smaller margin of error for treatment set-up and delivery than with conventional techniques.     One way to ensure the accuracy of treatment delivery is to image the prostate position daily,     prior to therapy, to allow for appropriate set-up corrections. To do so, imaging markers are     implanted into the prostate under guided ultrasound (a standard procedure at PMH). However,     there are disadvantages in using imaging markers which include added time to the treatment     planning process, and an invasive procedure with a potential for discomfort, bleeding and     infection. This study will investigate and compare X-ray volume imaging to the gold standard     imaging markers.   "
179714|NCT00196703|"     -  Aphasia, the loss or impairment of language caused by brain damage, is one of the most          devastating cognitive impairments of stroke. Aphasia can be treated with combination of          speech-language therapy and drugs. Conventional speech-language therapy in chronic          aphasic subjects is of little help and several drugs have been studied with limited          success. Therefore other therapeutic strategies are warranted.        -  Recent data suggest that drugs (memantine) acting on the brain chemical glutamate may          help the recovery of cognitive deficits, included language, in subjects with vascular          dementia. The present study examines the safety profile and efficacy of memantine paired          with intensive language therapy in subjects with stroke-related chronic aphasia (more          than 1 yr. of evolution).   "
179728|NCT00196885|"     The purpose of the study is to tests the hypothesis, that N-acetylcysteine (a     thiol-antioxidant)improves the exercise training effect on cancer patients that experience     weight loss (cachexia) as assessed by muscle mass and function as well as histomorphology.   "
179907|NCT00201123|"     This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb)     infection and will modulate that response with interferon-gamma.   "
179715|NCT00196716|"     People with Fabry disease have an alteration in their genetic material (DNA) which causes a     deficiency of the alpha-galactosidase A enzyme. This enzyme helps to break down and remove     certain types of fatty substances called glycolipids. These glycolipids are normally     present within the body in most cells. In people with Fabry disease, glycolipids build up in     various tissues such as the liver, kidney, skin, and blood vessels because     alpha-galactosidase A is not present, or is present in small quantities. The build up of     glycolipid levels (also referred to as globotriaosylceramide or GL-3) in these tissues is     thought to cause the clinical symptoms that are common to Fabry disease. Symptoms commonly     appear during childhood with pain in the hands and feet. This trial is designed to evaluate     the efficacy of a lower dose of Fabrazyme in patients who initially received 1.0 mg/kg every     2 weeks of Fabrazyme by investigating if the achieved clearance of glycosphingolipid deposits     in the vascular endothelium of the kidney can be maintained at a lower dose.   "
179716|NCT00196729|"     This study was conducted in patients with differentiated thyroid cancer who had undergone     near-total thyroidectomy. After surgery patients were randomized to one of two methods of     performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid     tissue). One group of patients who took thyroid hormone medicine and were euthyroid [i.e.     their thyroid stimulating hormone (TSH) levels are normal], and received injections of     Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second     group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e.     their TSH levels were high), and were given oral radioiodine. All patients received the same     amount of radioactive iodine (100 mCi or 3.7 GBq of 131I). Approximately 8 months later,     whole body scans were performed on all patients to learn whether the thyroid remnants had     been successfully ablated. The safety profile of Thyrogen when used for radioiodine remnant     ablation also was assessed. The Quality of Life, the radioiodine uptake and retention into     the thyroid bed, as well as radiation exposure to the remainder of the body also were     assessed in both groups of patients.   "
179717|NCT00196742|"     The Fabry Registry is an ongoing, international multi-center, strictly observational program     that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of     treatment status. No experimental intervention is involved; patients in the Registry undergo     clinical assessments and receive care as determined by the patient's treating physician.      The objectives of the Registry are:        -  To enhance the understanding of the variability, progression, and natural history of          Fabry disease, including heterozygous females with the disease;        -  To assist the Fabry medical community with the development of recommendations for          monitoring patients and reports on patient outcomes to help optimize patient care;        -  To characterize and describe the Fabry population as a whole; and        -  To evaluate the long-term safety and effectiveness of Fabrazyme®   "
179718|NCT00196755|"     The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to     calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal     dialysis.   "
179719|NCT00196768|"     Summary      Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB M3/M3v), by     the specific translocation t(15;17) and its molecular correlates (PML/RARa and RARa/PML).     Thereby it can be separated from all other forms of acute leukemia.      By all-trans retinoic acid in combination with chemotherapy cure rates of 70 to 80% can be     reached. On average, about 10% of patients still die in the early phase of the treatment and     about 20 to 30% relapse. Molecular monitoring of the minimal residual disease (MRD) by     qualitative nested RT-PCR and quantitative REAL-time PCR of PML/RARa allows to follow the     individual kinetics of MRD and to identify patients with an imminent hematological relapse.      A standardized treatment for patients with relapsed APL has not yet been established. With     arsenic trioxide (ATO) monotherapy remission rates over 80% were achieved and long-lasting     molecular remissions are described. The drug was mostly well tolerated. ATO exerts a dose     dependent dual effect on APL blasts, apoptosis in higher and partial differentiation in lower     concentrations. ATO was also successfully administered before allogeneic and autologous     transplantation. ATO is approved for the treatment of relapsed and refractory APL in Europe     and in the USA.      In the present protocol, ATO is given for remission induction:        1. in patients with hematological or molecular first or subsequent relapse of APL and        2. in patients who do not reach a hematological or molecular remission after first line          therapy.      Induction therapy with ATO is the mandatory part of the protocol.      After remission induction, there are several options for postremission therapy. Factors which     have influence on the treatment decision in the individual case are:        1. the eligibility for allogeneic transplantation        2. the eligibility for autologous transplantation        3. the presence or absence of contraindications against intensive chemotherapy        4. the PCR status after induction and during follow up (RT-PCR of PML/RARa, sensitivity          10-4)      A mandatory form of post-remission therapy is not defined in the protocol. Data and outcomes     of any post-remission therapy should be documented in order to collect data of treatment     after ATO.      The following stratification of post-remission therapy can be performed according to the     decision of the treating physician:      Patients with a HLA-compatible donor who are suitable for allogeneic stem cell     transplantation should be transplanted. In patients with a positive PCR one cycle of     intensive chemotherapy (HAM) before transplantation should be considered and patients with a     negative result are immediately transplanted without preceding chemotherapy. In patients who     do not qualify for allogeneic, but for autologous transplantation, the intensity of the     chemotherapy (Ara-C dose of the HAM cycle) is scheduled according to the PCR status after ATO     and to the patient's age. In patients under 60 years, the recommended single Ara-C dose is     scheduled to 3 g/m² in case of a positive PCR result and to 1 g/m² in case of a negative PCR     result after ATO. In all patients aged over 60 years, the Ara-C dose should be uniformly     reduced to 1 g/m² independent of the PCR status. Patients who are not eligible for allogeneic     or autologous transplantation (too old, no stem cells collected, PCR positive stem cell     transplant, contraindications against intensive chemotherapy) receive three further cycles     with ATO and ATRA. The group of patients not qualifying for autologous transplantation, but     without contraindications against intensive chemotherapy should receive an age adapted HAM,     whenever a positive PCR persists or reappears after the three maintenance cycles of ATO. A     close monitoring of the PCR of PML/RARa after each treatment cycle is part of the protocol.      The main objective of the protocol is to take advantage of the expected low toxicity of ATO     and to keep the part of chemotherapy as low as possible.   "
179720|NCT00196781|"     We plan to test the effectiveness of a recently developed computer-based program that is     designed to improve patient knowledge about prostate cancer treatments. It is also designed     to help men clarify their values using a computer-based 'decision aid.' A decision aid gives     patients tools to help them understand their own values and how these values may be related     to their choice of different forms of therapy for prostate cancer. In order to test the     effectiveness of the decision aid, men will be assigned on a chance basis to receive either     1) the computer program that includes the information about prostate cancer treatments alone,     or 2) the computer program that contains both the information and the decision aid. We expect     that men in decision aid group will be more active in their treatment decision and will have     improved knowledge, quality of life, and satisfaction with the treatment decision relative to     men who only receive the information.   "
179721|NCT00196794|"     Approximately 520 patients will be entered into this study taking place throughout Australia     and Europe. This study aims to determine if an investigational drug is safe and effective for     treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat     episodes of CDAD. The investigational drug will be evaluated in comparison to current     standard antibiotic treatment, so all patients will receive active medication. All study     related care is provided including doctor visits, physical exams, laboratory tests, and study     medication. The total length of participation is approximately 6 weeks.   "
179722|NCT00196807|"     The primary goal of this study is to develop and evaluate a print-based method of patient     education with a decision tool that is designed to provide detailed information about     prostate cancer and to clarify patient preferences and values, ultimately assisting men in     making an informed screening decision.   "
179723|NCT00196820|"     Study done in patients with metastatic breast cancer in order to determine the efficacy of     capecitabine   "
179727|NCT00196872|"     In the recent AGO-study, a dose-dense and dose-intensified sequence of Epirubicin -     Paclitaxel - Cyclophosphamide has shown superior efficacy compared to a conventionally dosed     sequence of Epirubicin / Cyclophosphamid and Paclitaxel and was therefore chosen as standard     treatment in this study.      The experimental arm of EC-TX combines several strategies: the combination of EC will be     administered every 2 weeks as a dose-dense regimen, the combination of TX can also be     considered as dose-dense due to the weekly application of paclitaxel. Furthermore there is     clinical evidence, that a combination of capecitabine and Paclitaxel provide synergistic     effects with improved tumour response. A randomized phase III study could demonstrate a     survival benefit of a combination of capecitabine with Docetaxel in patients with metastatic     breast cancer. This synergistic effect is probably based on the preclinical observed     taxane-mediated up-regulation of thymidine phosphorylase in the tumour cell, which give drive     to an increased transformation of capecitabine to its active form 5-Fluorouracil. Apart from     this synergy, the EC-TX regimen includes now 4 highly active compounds for the treatment of     breast cancer. The total doses of Epirubicin and Paclitaxel are identical in both arms. The     dosage of Cyclophosphamide is lower in the experimental arm, which is preferred due to the     induction of leukaemia at higher doses of Cyclophosphamide. The duration of both arms with 18     and 20 weeks is nearly similar.      The 2 by 2 factorial design of the trial provides the additional possibility to explore the     efficacy of a bisphosphonate as another strategy to further improve the prognosis of node     positive breast cancer.   "
179729|NCT00196898|"     Fibrotic valvular heart diseases are known as rare complications of long-time therapy of     Parkinson's disease with ergot-derivatives including some ergot-dopamine agonists. The aim of     this study is to assess the incidence of valvular heart disease, which may be an ergot-drug     agonists side-effect or an overall complication of all dopamine agonists. Incidence,     prevalence and addiction of dose or intake duration are not known so far. The reversibility     of the changes is unknown too. To answer these questions the present study is designed as a     cross sectional study followed by a 2 year follow-up prospective cohort study.   "
179730|NCT00196911|"     Assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus     compared with drug treatment alone in patients with advanced Parkinson's disease.   "
179731|NCT00196924|"     Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and     genitals in men and women. Several types of HPV infection are transmitted by sexual activity     and, in women, can infect the cervix (part of the uterus or womb). This infection often goes     away by itself, but if it does not go away (this is called persistent infection), it can lead     in women over a long period of time to cancer of the cervix. If a woman is not infected by     HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the     safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen     and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects     will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered     intramuscularly according to a 0-1-6 month schedule.   "
179732|NCT00196937|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the     uterus or womb). This infection may go away by itself, but if it does not go away (this is     called persistent infection), it can lead in women over a long period of time to cancer of     the cervix. This study will evaluate the immunogenicity and safety of GSK Biologicals     HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start.     Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly     according to a 0-1-6 month schedule. The study will be extended to assess long-term safety     and immunogenicity of the HPV-16/18 vaccine.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
179733|NCT00196950|"     The purpose of this study is to evaluate the safety, reactogenicity, immunogenicity and     persistence up to three years after administration of one dose of the MenACWY conjugate     vaccine when given to young adults aged 18-25 years.   "
179734|NCT00196963|"     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one     dose of four different formulations of the MenACWY conjugate vaccine when given to healthy     subjects aged 15-19 years. The selection of the best formulation will be based on data     obtained up to one month after the vaccine dose.   "
179735|NCT00196976|"     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one     dose of four different formulations of the MenACWY conjugate vaccine when given to healthy     children aged 12-14 months and 3-5 years. The selection of the best formulation will be based     on data obtained up to one month after the vaccine dose.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
179736|NCT00196989|"     This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a     range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects     with T2DM (Type 2 Diabetes Mellitus).   "
179737|NCT00197002|"     This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose     inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in     children as young as 15 months of age.   "
179738|NCT00197015|"     This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose     inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a     varicella (chickenpox) vaccine in children as young as 15 months of age.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
179749|NCT00198991|"     The study evaluates the efficacy and tolerability of an intensified induction and     consolidation therapy. Thereafter patients receive individualised treatment stratified     according to relapse risk with stem cell transplantation for patients with high and very high     risk of relapse. Patients with standard risk receive further consolidation and reinduction     chemotherapy. In parallel minimal residual disease (MRD) is evaluated. After six months and     one year the decision on intensification or discontinuation of therapy is made based on the     results of MRD evaluation.   "
179739|NCT00197028|"     GSK Biologicals is developing in partnership with the Program for Appropriate Technology in     Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine for the routine     immunization of infants and children living in malaria endemic areas. The vaccine would offer     protection against malaria disease due to the parasite Plasmodium falciparum. The vaccine     would also provide protection against infection with hepatitis B virus (HBV).      This trial is being carried out following the demonstration of efficacy of a previous version     of the malaria candidate vaccine in children in Mozambique: there, the vaccine demonstrated     approximately 30% efficacy against clinical episodes of malaria and approximately 58%     efficacy against severe malaria disease.      In order to integrate the malaria vaccine into the Expanded Program on Immunization (EPI)     regimen, in malaria-endemic regions, for this trial, a 0.5 ml dose of GSK 257049 vaccine has     been developed. The Protocol Posting has been updated in order to comply with the FDA     Amendment Act, Sep 2007.   "
179752|NCT00199030|"     This study tests the effectivity and tolerability of treatment with alemtuzumab (MabCampath)     in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or     T-lymphoblastic lymphoma. In Arm A, patients with refractory relapse receive a 2 week     treatment with MabCampath followed by remission evaluation. In case of insufficient response,     treatment with cladribine is added. In Arm B, patients with molecular relapse (minimal     residual disease) receive a 4 week treatment with MabCampath followed by remission     evaluation. In both arms, treatment is continued in case of response for up to two months.   "
179814|NCT00199849|"     To estimate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by PMED in     patients with tumor type known to express NY-ESO-1 or LAGE-1 using frequency, severity, and     duration of treatment-related adverse effects as endpoints.   "
179740|NCT00198874|"     This Stage II study is in response to NIDA's Behavioral Therapies Development Program     (PA-99-107). A randomized clinical trial is proposed to evaluate the direct, mediated, and     moderated effects of Integrated Family and Cognitive-Behavioral Therapy (IFCBT), a     multisystems treatment for adolescent drug abuse with promising efficacy results. In the     first study aim, we seek to evaluate the separate and possibly synergistic effects of family     systems and cognitive-behavioral IFCBT components on posttreatment drug abuse problem     severity, problem behavior, psychiatric distress, and academic achievement of adolescent drug     abusers. Innovative analytic strategies are subsequently used to evaluate the degree to which     successful outcomes are attributable to specific familial and cognitive-behavioral change     processes targeted by IFCBT components. The possibility of effect-modification also is     considered, with a focus on neurocognitive, psychiatric comorbidity, and demographic factors.     Namely, we seek to understand how variations in specific client characteristics, such as     executive dysfunctions or psychiatric comorbidity, might explain why treatments work for some     drug abusing youths but not others. In addition to promising findings on IFCBT efficacy, this     Stage II proposal benefits from the development and Stage I study application of (a)     treatment manuals; (b) therapist training procedures; (c) therapist adherence and competence     tools; (d) a neuropsychological battery to assess cognitive functions; (e) a psychodiagnostic     battery to assess comorbid psychiatric disorders; and (f) a study assessment battery     comprised of therapeutic process and outcome measures. This revised application has sought to     address well-taken concerns cited by the reviewers while maintaining proposal strengths. The     lack of adolescent drug treatment research continues to be a serious gap in the addictions     literature despite alarmingly high rates of drug abuse among youth and the range of     morbidities and mortality that result nationwide. If successful, this project should help to     identify specific behavior change processes targeted by family systems and     cognitive-behavioral treatments that foster subsequent reductions in drug use and problem     behavior among recovering youth. Neurocognitive and psychiatric influences on adolescent drug     treatment outcomes appear to be significant yet are poorly understood. Increasing our     understanding of relationships between client characteristics, skill development during     treatments, and subsequent outcomes should also help to improve adolescent drug treatments.   "
179741|NCT00198887|"     This study is designed to look at how operations are carried out in relation to improving the     health and survival of newborn babies in India.   "
179742|NCT00198900|"     To assess the knowledge of both type 2 diabetics and non-diabetics on diabetes, nutrition,     and exercise. Although type 2 diabetics should know more about their disease and its needs,     it is not expected they will know significantly more than the lay public.   "
179743|NCT00198913|"     Part 1 of this research demonstrated that type II diabetics are lacking in knowledge of how     to best treat their illness with dietary controls. Most had little nutrition or diabetes     knowledge. Part 2 demonstrated that providing a 40% reduction in fat intake across three     meals versus all at one meal was more effective in glycemic control. Part 3 is designed to     incorporate these findings into a long-term free living setting through education and     behavior/dietary modification.   "
179744|NCT00198926|"     A short-term feeding study in type 2 diabetics manipulating the fat and caloric values of     meals to assess both compensation and glucose control, both covertly and overtly.   "
179745|NCT00198939|"     In this R01 study, a randomized clinical trial is proposed to evaluate the efficacy of a drug     abuse prevention intervention for indicated middle school youth that coordinates family and     teen-based components. The Family Management Intervention is comprised of a parent-focused     curriculum to foster parenting skills followed by brief family therapy to foster adaptive     family communication and age-appropriate roles. The Teen Achievement Intervention is     comprised of a clinician-delivered learning strategy curriculum to foster academic     achievement followed by a similar yet peer-facilitated curriculum to foster self-efficacy and     prosocial peer networks. In the first study aim, we seek to evaluate the separate and     possibly synergistic effects of the Family Management and Teen Achievement components on post     intervention drug use, problem behavior, psychological distress, and academic achievement of     indicated youth. Innovative analytic strategies are subsequently used to elucidate mediated     pathways by which the interventions might reduce drug involvement and problem behavior by     promoting changes in targeted skills and behavior change processes. The possibility of     effect-modification also is considered, with a focus on neurocognitive,     internalizing/externalizing, and demographic factors, in an effort to discern why     interventions work for some youth but not others. This application revision has sought to     address well-taken concerns cited by the reviewers while maintaining proposal strengths. In     response to a key limitation, this revision includes further specification of anticipated     relationships between neurocognitive variables, skill acquisition levels, and prevention     intervention outcomes among indicated youth. Study hypotheses on specific neurocognitive     effects are informed by empirical findings and the clinical experience of investigative team     members specializing in neuropsychology. If successful, this project should improve     prevention practices by identifying malleable behavior change processes fostered by effective     interventions. Improving our understanding of how individual characteristics of indicated     youth, such as neurocognitive deficits or externalizing problems, influence the development     of skills during interventions and subsequent outcomes may also help to improve existing     prevention interventions. The significance of the proposed study is underscored further by     the substantial size of the targeted population of indicated youth, and the range of     morbidities and mortality that often result when early warning signs of drug abuse are not     addressed.   "
179746|NCT00198952|"     to test safety and efficacy on metabolism, heart rate, blood pressure, TSH (and other     blood)and hunger/caloric compensation on ephedra versus placebo   "
179747|NCT00198965|"     This study will be conducted over three phases. Phase I will be a 16-week weight lass phase.     Phase II will be a 52-week maintenance phase. Phase III will be a follow-up phase. We will     test three diet regimens: 1) an olestra group who will receive a weight-reducing diet that     includes olestra-containing products; 2) a triglyceride group who will receive the same     weight-reducing diet but with foods made with triglyceride (regular fat); 3) a low-fat group     will be instructed to consume a diet made of traditionally low-fat foods that ate available     in grocery stores (no olestra foods). These groups will be re-randomized for the maintenance     phase and again assigned to one of the three weight loss regimens described above: olestra,     triglyceride, or low-fat. In the double-blinded experimental design, groups receiving olestra     foods will not be informed of the nutrient contents of the foods or told what fat substitute     is used in the preparation. (The consent form will state that a new fat-substitute may be     used in the study foods.) During a “run-in” phase, olestra versus regular-fat food sensory     and tolerance tests will be conducted.   "
179748|NCT00198978|"     The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the     treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression     of CD20 on leukemic cells the efficacy and tolerability of additional application of     Rituximab together with chemotherapy is evaluated.   "
179750|NCT00199004|"     The study evaluates the efficacy and tolerability of an intensified induction and     consolidation therapy in combination with rituximab in CD20 positive standard risk patients.     Thereafter patients receive additional consolidation and reinduction cycles combined with     rituximab. In parallel minimal residual disease is evaluated. After six months and one year     the decision on intensification or discontinuation of therapy is made based on results of MRD     evaluation   "
179751|NCT00199017|"     This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma     (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year     of intensive cyclical chemotherapy with additional prophylaxis for central nervous system     (CNS) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation     after induction chemotherapy.   "
179815|NCT00199862|"     The purpose of this study is to determine whether our drug, 124I-huA33, can safely detect     colorectal cancer.   "
179753|NCT00199043|"     In this study the efficacy and tolerability of two approaches to treat and prevent     hyperuricemia is tested in patients with acute lymphoblastic leukemia or high-grade lymphoma     with high risk of tumor lysis syndrome. Both arms are compared by randomisation. In one arm     patients receive during pre-phase chemotherapy conventional prophylaxis with allopurinol     whereas in the other arm Rasburicase is used.   "
179754|NCT00199056|"     The study evaluates the efficacy and tolerability of an intensified induction and     consolidation therapy. Thereafter patients receive individualised treatment stratified     according to relapse risk with stem cell transplantation for patients with high and very high     risk of relapse. Patients with standard risk receive further consolidation and reinduction     chemotherapy. In parallel minimal residual disease (MRD) is evaluated. A MRD based risk     stratification and treatment decision is developed.   "
179755|NCT00199069|"     The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy     over one year, followed by randomized either intensified or conventional maintenance therapy.     It includes a distinct protocol for the subgroup 'mature B-ALL',   "
179756|NCT00199082|"     The study evaluates the efficacy and tolerability of alternating short cycles of high-dose     and conventional chemotherapy in combination with rituximab in CD20 positive patients,     followed by local radiation therapy in the case of initial mediastinal or central nervous     system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is     offered for patients estimated to be over 55 years, biologically.   "
179757|NCT00199095|"     The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in     elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of     induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance     therapy   "
179758|NCT00199108|"     Patients with acute lymphoblastic leukaemia or very aggressive lymphoma and documented     isolated CNS relapse or CNS relapse combined with other relapse sites should receive therapy     with intrathecal DepoCyte at least once. Treatment may be repeated during induction phase     each 2 weeks and monthly during maintenance phase. The study aim is to replace the usual 2-3     weekly applications of intrathecal triple therapy with one application of DepoCyte. Primary     objective is the response rate after one application of DepoCyte. Further objectives are the     compilation of data regarding safety and toxicity   "
179759|NCT00199121|"     The purpose of this study is to evaluate the antiviral effect and durability of antiviral     response (HIV-1 RNA PCR) and safety of a triple NtRTI/NsRTI therapy in antiretroviral naive     patients. Patients will receive TDF plus FTC plus AZT for at least 48 weeks. Further     objectives are to evaluate resistance pathways in failing patients treated with TDF/FTC/AZT     and to evaluate a treatment strategy of sparing PIs and NNRTIs for later treatment.   "
179760|NCT00199134|"     Find a genetic signature of de novo resistance to letrozole in adjuvant breast cancer;   "
179761|NCT00199147|"     Aim of the study is to compare the efficacy of intensive induction therapy with Cytarabine,     Idarubicin and Etoposide (IdAV) given in parallel with (G-CSF priming) and followed by G-CSF     versus the same IdAV chemotherapy only followed by G-CSF (without priming) in elderly     patients with de novo AML, secondary AML and advanced MDS. Moreover, the ability to mobilize     sufficient numbers of peripheral blood stem cells (PBSC) for autologous PBSC transplantation     after consolidation therapy with dose-reduced FLAG-Ida chemotherapy followed by G-CSF will be     evaluated.   "
179762|NCT00199160|"     This is a Phase II trial evaluating the efficacy and the biological activity of BAY 43-9006     in patients with recurrent and/or metastatic head and neck cancer.   "
179763|NCT00199173|"     This is a Phase III trial comparing hepatic intra-arterial injection of Yttrium-90     microspheres (selective internal radiation [SIR] spheres) versus infusional intravenous (IV)     5FU in colorectal cancer metastatic to the liver only and refractory to standard IV     chemotherapy.   "
179764|NCT00199186|"     The aims of the study are to determine whether single agent imatinib (STI571; Glivec) is more     effective as up-front remission induction therapy than conventional multi-agent induction     chemotherapy for elderly patients with Philadelphia positive (Ph+)ALL, whether this treatment     is better tolerated, and whether subsequent combination therapy with imatinib and     chemotherapy of approximately a 1 year duration is tolerable and effective with respect to     maintaining remissions.   "
179765|NCT00199212|"     The main objective of this study is to determine the feasibility of the combination of the     proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) and to     determine the best dose of bortezomib to combine with two trastuzumab schedules, weekly and     3-weekly.   "
179787|NCT00199498|"     The purpose of this study is to examine whether RV (right ventricular)septal pacing has any     effect on LV ( left ventricular) function than RV apical pacing in patients who require     ventricular pacing.   "
180052|NCT00193180|"     This trial evaluates the novel combination of docetaxel with imatinib as first or second line     therapy in advanced breast cancer with the aim of achieving higher effectiveness and     potentially reducing side effects.   "
179766|NCT00199225|"     This phase I trial will evaluate the effects of rupatadine, at a dose of 10 mg OD (authorised     and marketed dose) and the 100mg/day (supratherapeutic dose) on the ECG parameters with a     special focus on its effect on cardiac repolarisation (QTc interval duration).Furthermore,     the study is performed to assess the pharmacokinetic-pharmacodynamic relationship between     plasma concentration of rupatadine and its effects, if any, on cardiac repolarisation mainly     in the QTc interval).      The main objective is to assess whether administration of a repeated dose of 10 and 100     mg/day , has the potential to cause QT prolongation in healthy volunteers.   "
179767|NCT00199238|"     The objective of this study is to evaluate the efficacy and safety of rupatadine for the     treatment of CIU symptoms.To assess the clinical efficacy of a dose ranging of rupatadine     fumarate (5mg, 10mg, and 20 mg) compared with placebo for relief of CIU symptoms.   "
179768|NCT00199251|"     · To evaluate the efficacy of rupatadine 10 and 20 mg for the treatment of CIU symptoms over     four-week treatment period in comparison with placebo.   "
179769|NCT00199264|"     To compare the therapeutic efficacy of 10 mg, 40 mg, 80 mg, 160 mg and 320 mg of     albaconazole, as a single oral dose, in women affected by acute non-complicated     vulvovaginitis due to Candida spp.   "
179770|NCT00199277|"     The main objective of this study is to evaluate the efficacy of intravenous iron sucrose in     increasing preoperative haemoglobin values in patients with colo-rectal neoplasm and iron     deficiency anemia, compared to the standard treatment with oral iron. It will also determine     whether intravenous iron sucrose administration improves outcomes such as postoperative     haemoglobin values, serum ferritin values, transfusional needs, postoperative complications,     or length of hospital stay.   "
179771|NCT00199290|"     This study is designed to evaluate the efficacy and the safety of Trafermin(recombinant human     basic fibroblast growth factor: rhbFGF) in Japanese patients with marginal periodontitis, in     order to verify the superiority of Trafermin to placebo, and to determine the recommended     therapeutic dose.   "
179772|NCT00199303|"     We studied the effect of dextromethorphan (DEX), an N-methyl-d-aspartate antagonist, on     analgesic consumption and pain scoring after abdominal hysterectomy. Our aim was to compare     the analgesic effectiveness and incidence of adverse side effects of oral DEX with placebo     (P)   "
179773|NCT00199316|"     postoperative pain after kidney surgery is very high. We always use PCA for postopertive     pain. But almost patients still had severe pain. We try to use spinal morphine before     operation aims to reduce pain.   "
179774|NCT00199329|"     PCA morphine always introduces nausea and vomiting during the postoperative period.     Ondansetron can reduce PONV (postoperative nausea vomiting). We, the researchers at Khon Kaen     University, are trying to add ondansetron in PCA morphine. Patients receive a small dose of     ondansetron when they request morphine.   "
179775|NCT00199342|"     This is a dose escalating cohort study to determine the maximum tolerated dose (MTD) of     KW-2871 (in dose cohorts of 60, 80, and 100 mg/m2) when administered with a specified     premedication regimen (ranitidine, diphenhydramine, and dexamethasone). KW-2871 will be     administered at 14-day intervals.   "
179776|NCT00199355|"     To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the     percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with     levodopa.   "
179777|NCT00199368|"     This is a 1-year, open-label, long-term safety extension for patients who have completed     prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.   "
179778|NCT00199381|"     This is an, open-label, long-term safety extension for patients in North America who have     completed the prior istradefylline study 6002-INT-001.   "
179779|NCT00199394|"     The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline     (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with     advanced Parkinson's disease treated with levodopa.   "
179780|NCT00199407|"     To establish the efficacy of a 20 mg/day dose of istradefylline for reducing the percentage     of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.   "
179781|NCT00199420|"     To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the     percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with     levodopa.   "
179782|NCT00199433|"     The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40     mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.   "
179783|NCT00199446|"     The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40     mg per day of istradefylline (KW6002) in patients with Restless Legs Syndrome.   "
179784|NCT00199459|"     Urinary protein levels are not routinely measured in stone patients while there is strong     evidence that proteins play a role in the etiology of stones. The purpose of this study is to     examine the urinary and serum proteins of stone formers compared to healthy subjects     utilizing the high throughput method, Surface Enhanced Laser Desorption/Ionization (SELDI).     We hypothesize that there is a unique set of proteins expressed in serum and urine in stone     patients that can be detected by SELDI. Ultimately, this will better our understanding of     stone disease and help develop new prevention strategies.   "
179785|NCT00199472|"     Renal blood flow is inversely related to obstruction. We propose that this imaging will be as     effective as the diuretic renogram in the functional diagnosis of obstruction. Furthermore,     dynamic contrast CT scanning may also add anatomic information necessary for the surgical     treatment.   "
179786|NCT00199485|"     Men undergoing androgen deprivation therapy for prostate cancer may experience significant     side effects including symptoms of intense heat, facial flushing, and sweating. These     so-called hot flashes are similar to those experienced by women during menopause. A     traditional Chinese herbal preparation, Dong Quai, has been used for thousands of years to     reduce the incidence and severity of hot flashes. Anecdotal evidence exists to support the     use of Dong Quai in men treated with androgen deprivation therapy for prostate cancer.      Recently, the awareness and use of herbal remedies and over-the-counter preparations for a     number of different conditions have increased dramatically. This trial was, therefore,     designed to determine if Dong Quai significantly reduces the incidence and severity of hot     flashes in men following androgen deprivation therapy for prostate cancer.   "
179788|NCT00199511|"     The purpose of this study is to evaluate the effect of Hypertonic Saline 7.5% vs Mannitol 20%     on brain bulk (using a 4 point scale), intracranial pressure (subdural catheter)and the     changes on serum and urinary Na, K and Osmolarity during elective craniotomy for brain tumor     resection.   "
179789|NCT00199524|"     Patients with upper ureteral or renal stones will be randomized to undergoing ureteroscopy     with or without a ureteral access sheath. The sheath is designed to facilitate ureteroscope     insertion and re-insertion, thus allowing fragments to be basketed out. Stone free rates at 3     months will be determined between the two groups.      The investigators hypothesize that the use of the ureteral access sheath with ureteroscopy     will result in improved stone free rates at 3 months compared to ureteroscopy without use of     a sheath.   "
179790|NCT00199537|"     Patients with advanced prostate cancer undergoing adjuvant treatment with androgen blockade     will be followed over a 1 year interval to assess the effects of this treatment on bone     metabolism. It is expected that men undergoing androgen blockade will experience accelerated     bone loss.   "
179791|NCT00199550|"     This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral     prostatectomy) in men with symptomatic benign prostatic hyperplasia.   "
179792|NCT00199563|"     -  To evaluate the impact of nightly sildenafil vs placebo use on diabetic men with and          without proven endothelial dysfunction and coexisting erectile concerns.        -  To determine if chronic sildenafil use compared to placebo positively impacts          endothelial function among a cohort of diabetic mend with erectile dysfunction        -  To assess the salvage rate of sildenafil - failures who demonstrate improved response          rates over time with chronic use        -  To assess if microalbuminuria predicts flow-mediated dilation (FMD) response        -  To measure and identify if other patient specific characteristics predict for sildenafil          erectile response and flow-mediated dilatation (FMD) response over time (patient          specifics; blood pressure, HBA1c, weight, BMI, age IIEF score at baseline)   "
179793|NCT00199576|"     Tracheal intubation is a frequent procedure in intensive care units (ICU). Post-extubation     laryngeal edema is a frequent complication with potential morbidity and mortality, and may     lead to urgent tracheal re-intubation. Corticosteroids have been proposed to reduce the     incidence of post-extubation laryngeal edema. A few clinical studies have been conducted in     adult ICU patients and have led to discrepant results. These discrepancies may be related to     the time lag separating the administration of the corticosteroids and the planned extubation.     Accordingly, we tested the hypothesis that pretreatment with corticosteroids initiated 12     hours before a planned extubation may efficiently prevent the occurrence of postextubation     laryngeal edema in critically-ill adults who have been mechanically ventilated for more than     36 hours in the ICU.   "
179794|NCT00199589|"     This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with     or without selective injection of BTA (Botox).   "
179795|NCT00199602|"     This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative     3-arms of 140 patients (i.e. 420 total patients).      Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months   "
179796|NCT00199615|"     The guidelines and institutional practices recommended more frequent visits the two years     following curative-intent therapy for non-small cell lung cancer (NSCLC).No international     consensus is published concerning follow-up of resected NSCLC patients.Recent studies have     outlined that positron emission tomography (PET) scanning may be accurate in early detection     of recurrences by comparison to computed tomography (CT). The aim of this study is to compare     follow-up by conventional methods versus PET. Patients are randomly assigned to two arms. In     the first arm, thorax CT with liver and adrenal gland sections, abdominal ultrasonography and     nuclear bone scintigraphy are performed every 6 months after surgery for two years. In the     second arm, PET scanning is only. For brain metastasis detection, CT is performed in the two     arms. Recurrences are detected during scheduled or unscheduled procedure in asymptomatic     patients. PET and CT are interpreted separately by two nuclear physicians and two     radiologists. The direct cost of follow-up procedure is determined in the two groups. The     calculated sample is composed of 60 patients in each arm to detect significant difference.     The Ethics Committee of Universitary Hospital of Limoges approves the study.   "
179797|NCT00199628|"     Problems of compatibility between a mother and her child are frequent. The most well-known     case can be illustrated by the fetomaternal blood group incompatibility (rhesus factor) which     can induce severe anemia of the fetus.      The investigators recently proved that incompatibility between mother and child can concern     an organ leading to a tissular alloimmunization. For example, neonatal membranous     glomerulonephritis (a kidney disease) can result from this mechanism.      The purpose of this network is to detect and study neonatal diseases induced by tissular     fetomaternal alloimmunization. The detection of these diseases will be performed by the     mother's serum analysis.   "
179798|NCT00199641|"     The aim of this study is to compare two strategies of early enteral nutrition in terms of     efficacy and complications in mechanically ventilated patients.   "
179799|NCT00199654|"     The follow up of colorectal cancer after curative surgery has to find loco-regional relapses     or synchronous metastases, and to detect adenomas and new cancer on the rest of the colon.      The increase of survival after relapse of the colorectal cancer depends on the possibility of     curative action or after chemotherapy response.      This is a Phase III open-labeled, multicenter, multidisciplinary, randomised study, comparing     2 arms of 188 patients (i.e. 376 total patients).      Study Period (date of first inclusion/last inclusion): 3 years.      Follow Up: 3 years.      The primary objective is the evaluation of PET performance in the earlier relapse detection     of the colorectal cancer relapse in comparison with conventional control (including     carcinoembryonic [CEA] levels and other classic radiological exams).   "
179859|NCT00200434|"     The purpose of this study was to contrast the efficacy and safety of 3 dose levels of     nebivolol vs. placebo, when added to a patient's existing antihypertensive medication(s) for     3 months, in patients with mild to moderate hypertension   "
179860|NCT00200447|"     This study conducted to more fully evaluate the way that carbidopa/levodopa and entacapone     may work in the brain. This research study uses [123I]-IBZM and dynamic SPECT imaging to     determine the amount and the duration of dopamine release from specific regions in the brain     after treatment with either the combination of carbidopa/levodopa or the combination of     carbidopa/levodopa/entacapone.   "
179800|NCT00199667|"     Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and     tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and     then minimize side effects in the long term. However definitive proof is still lacking. We     conducted a randomized study in 11 french centers and included 137 kidney transplant     recipients (PRA<50%) receiving a classical immunosuppressant regimen with basiliximab, Csa,     MMF and steroids. The fixed dose group received 2 g of MMF a day. The concentration     controlled group received MMF dose adapted to the area under the concentration curve (AUC)     of MPA, with a target of 40 h.mg/L. After transplantation AUCs were calculated with a     Bayesian estimator using a 3-point limited sampling strategy on day 7, 14, and months 1, 3, 6     , 12 in both groups (values note communicated to the physicians in the fixed dose group.   "
179813|NCT00199836|"     This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with     2 other agents to help stimulate the immune system. Peptides are small fragments of every     protein. These peptides are normally found in the testis and the placenta. They have also     been found on various types of cancer cells. The purpose is to stimulate the immune system to     react against the peptides that are found on cancer cells   "
179801|NCT00199680|"     In cervical cancer prognosis factors are size of the tumour, pelvic and para-aortic lymph     nodes involvement. The initial treatment taking is determined by lymph node evaluation.      Early stage cervical cancers at their very beginning, with no lymph node involvement, will be     treated either by surgery only or by radiotherapy only, or by both at the same time. At     advanced stages, from proximal IB to IIB with bad prognosis (tumour larger than 4 cm and     pelvic lymph node involvement), as well as for cancers up to distal stages IIB, III and IVA,     treatment relies on radio-chemotherapy, either alone or pre-surgery.      The pre-therapeutic complete examination of the cervical cancer includes a clinical     examination and a pelvic MRI in order to look for pelvic and para-aortic lymph nodes and to     precise the volume and the spreading of the tumour in the pelvic area.      A meta-analysis estimating the interest of the MRI showed a variable sensitivity and a     specificity for the detection of such lymph node metastasis with a sensitivity varying from     24 to 75 % and a specificity between 84 and 100 % according to the studies.      As for the use of an 18-FDG PET scan to detect lymph node involvement, the studies realized     so far are performed, usually, on a small number of subjects and with heterogeneous     populations. However, it seems that such an examination enables a better detection of lymph     nodes than the MRI does, especially for para-aortic lymph nodes depending on the studies,     sensitivity varies from 57 to 100 %, and specificity between 92 and 100 %.      We propose a prospective, multicentric and multidisciplinary study for the estimation of     diagnosis methods. The main aim is to estimate the interest of the 18-FDG PET scan for the     detection of pelvic and para-aortic lymph node metastasis in patients with cervical cancer,     in comparison with the MRI. This study should enable to include 380 patients within 3 years.     An 18-FDG scintigraphy will be performed before any treatment together with an MRI. A     comparison between the sensitivity and the specificity of both examinations will be     established and a correlation with the histology of the lymph node dissection will be made.   "
179802|NCT00199693|"     This study looks at hemodynamic and respiratory function in healthy pregnant women; it is a     longitudinal study.   "
179803|NCT00199706|"     The purpose of this study is to determine whether 7.2% NaCl in 6% hydroxyethyl starch will     lower intracranial pressure (ICP) in SAH-patients with normal or moderately elevated ICP in a     placebo controlled study, and to describe the haemodynamic effects.   "
179804|NCT00199719|"     Peg interferon and ribavirin currently represent the standard approved association for     treating patients infected with hepatitis C virus (HCV) . The adjunction of amantadine is     expected to gain about 10 % of sustained virological response (SVR) . Unfortunately, about 50     % of the patients remain relapsers or virological non responders. The main predictive factors     of SVR are HCV genotype and body weight (BW). The impact of the drug pharmacological     properties, particularly those of ribavirin requires complementary studies. This drug has a     large distribution volume and its concentrations display large inter-individual variability.     Two studies performed in HCV patients found no correlation between ribavirin dose adjusted on     BW and a single ribavirin time point serum concentration at steady state.      The aim of this study is to investigate the pharmacokinetic-pharmacodynamic relationships of     ribavirin in hepatitis C patient   "
179805|NCT00199732|"     Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic     hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the     liver.      Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment.      The major interest of this marker is that it can be measured by a simple blood test instead     of a liver biopsy.   "
179806|NCT00199745|"     The primary objective of the study is to investigate whether differences in atorvastatin     metabolite ratios might have a positive or negative predictive value in diagnosing     atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.   "
179807|NCT00199758|"     The optimal strategy in advanced non small cell lung cancer with stable disease is not well     known. There is no published study assessing an early change of chemotherapeutic drugs in     these patients.Accordingly, we conduct this trial with the objective to improve the rate of     objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine     association for patients with stable diseases (SD).   "
179808|NCT00199771|"     The purpose of this study is to determine whether infusion of hypertonic saline dextran     attenuates the inflammatory response and the water overload, during and after major cardiac     surgery in small children.   "
179809|NCT00199784|"     The purpose of this study is to determine the effect of low dose versus standard dose spinal     anesthesia with and without intravenous phenylephrine-infusion on blood pressure, cardiac     output and systemic vascular resistance.   "
179810|NCT00199797|"     Although treatment for metastatic colo-rectal cancer has improved significantly over the     recent years, it still remains a significant health problem representing the leading cancer     by incidence in the United States of America. In search for new therapies monoclonal     antibodies have been developed to specifically target human colon cancer cells. huA33 is an     antibody that reacts with the A33 antigen which is produced by colorectal cancers. Prior     studies have shown that application of the huA33 antibody may delay the growth of tumor cells     producing the respective antigen. Oxaliplatin and 5-FU are cytotoxic agents which are     considered as standard treatment in metastatic colorectal cancer. Leucovorin is a vitamin     which enhances the effect of 5FU. Eligible patients with advanced colorectal cancer will     receive huA33, 10 mg/m2 by intravenous (IV) infusion weekly for twelve weeks. On Study Day 15     (week 3), 5-FU, leucovorin (folinic acid), and oxaliplatin will be administered every 2 weeks     for 10 weeks. Patients will be evaluated weekly for toxicity. Blood samples will be obtained     every week for hematology and serum biochemistry analysis and for determination of human     anti-human antibody (HAHA). In patients with measurable disease, tumors will be assessed by     the appropriate scan at baseline and at the end of the thirteen week cycle. The primary     objective of this study is to assess the safety of huA33 + 5FU + leucovorin + oxaliplatin.     The secondary objective is to measure the immunogenicity of huA33 when given in combination     with 5FU plus leucovorin with oxaliplatin and to document tumor responses.   "
179811|NCT00199810|"     This trial is examining hemodynamic measurements in women with serious preeclampsia.   "
179861|NCT00200460|"     The purpose of this study is to evaluate the effects of various doses of nebivolol in     patients with mild to moderate hypertension.   "
179812|NCT00199823|"     Objectives      Intracoronary transplantation of different cell populations have been used in acute     myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study     is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells     (mBMC) improve left ventricular ejection fraction (LVEF) after anterior wall AMI.      Design      The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with     acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute PCI are     randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 days     after PCI or to control. Left ventricular function, exercise capacity, biochemical status,     functional class, quality of life and complications are validated at baseline and during a     12-month follow up.   "
179816|NCT00199875|"     This is a phase 1 study that will only be carried out at Memorial Sloan-Kettering Cancer     Center. Patients will receive a radiolabeled antibody, called Yttrium-90 chimeric G250     (90Y-cG250).The goal of a phase 1 trial is to establish a safe dose range based on side     effects;in other studies, these side effects have been reversible and lasted a short time     (hours to days). If possible, the trial will also give us an idea of how well the drug might     work in treating your disease.   "
179817|NCT00199888|"     The purpose of this study is to see if an antibody (cG250)attached to a radioactive substance     (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled     for surgery.   "
179818|NCT00199901|"     The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine     improves outcomes for people with Malignant Melanoma which has been removed, but is at high     risk of relapse.   "
179819|NCT00199914|"     The purpose of this study is to determine whether shortwave diathermy is effective in     reducing knee pain and increasing function of the patients with knee osteoarthritis.   "
179820|NCT00199927|"     End stage renal disease (ESRD) is rapidly growing worldwide. Patients with ESRD have     increased morbidity and mortality mostly because of a dramatic excess of cardiovascular     disease. Thus, preventing or limiting the progression of chronic nephropathies, in addition     to limit the incidence of ESRD, may also postpone death. Drugs that inhibit the renin     angiotensin system, such as Angiotensin-Converting-Enzyme inhibitors (ACEi) and Angiotensin     II receptor antagonists (ATA), are reno- and cardio-protective in the long-term. There are     data that statins,in addition to limit cardiovascular events may have specific     reno-protective properties.      Thus we designed a study aimed to evaluate whether statins associated to ACEi and ATA may     have an additional reno-protective effect.      ESPLANADE is a multicenter, prospective, randomized, parallel group study in which, after 2     months treatment with ACEi and ATA, two groups of 90 patients, with or without type 2     diabetes, are randomized to 6 months Fluvastatin (40 or 80 mg/day) treatment YES or NO.Twenty     Italian Nephrology Units are involved in the trial. The study is fully coordinated by the     Clinical Research Center for Rare Disease Aldo e Cele Daccò, Villa Camozzi, Ranica.   "
179821|NCT00199940|"     The purpose of this research is to determine if Ziprasidone is safe and effective for use in     children and adolescents with a psychotic illness, and to determine of Ziprasidone treatment     leads to weight changes in children.   "
179822|NCT00199953|"     Objectives of this study are:        -  To quantitatively evaluate the relationship between extraesophageal manifestations of          gastroesophageal reflux (EER) and postnasal drainage(PND)in a group of patients without          radiographic or endoscopic evidence of sinonasal inflammatory disease.        -  To assess the efficacy of BID proton pump inhibitors (PPI) in the management of patients          with symptomatic postnasal drainage.   "
179823|NCT00199966|"     The purpose of this research is to compare how safely and how well this medicine works in     treating children and teenagers between the ages of 6 and 17 years with a diagnosis of     Bipolar Disorder.   "
179824|NCT00199979|"     The study will compare the immuno-virological efficacy, and safety, of a once daily     antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily     association (fixed dose combination of zidovudine/lamivudine + nevirapine) in ARV-Naive HIV-1     infected subjects, with CD4 cell count below 350/µL or below 15%, whatever the viral load.     Pharmacological (nevirapine concentrations) and virologic data (resistance mutations in case     of failure) will also be provided, as well as adherence rate and quality of life in respect     of the treatment arms.   "
179825|NCT00199992|"     Comparison of wound healing treatments; platelet gel vs. control   "
179826|NCT00200005|"     Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with     InterStim Therapy to treat fecal incontinence or constipation   "
179827|NCT00200018|"     The purpose of this study is to test the effect of an implanted device that stimulates the     stomach on weight loss in patients suffering from obesity and type 2 diabetes.   "
179828|NCT00200031|"     A study to examine the impact that Interstim Therapy for Urinary Control has on health care     utilization and costs within a health care system and the satisfaction with treatment     expressed by patients using this therapy.   "
179829|NCT00200044|"     The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair     System to provide symptomatic relief is subjects with gastroesophageal reflux disease.   "
179862|NCT00200473|"     A study to determine the safety, efficacy and superiority of nebivolol to placebo for the     treatment of elevated blood pressure in patients with mild to moderate hypertension.   "
179863|NCT00200486|"     The purpose of this study is to study the genetic profile of head and neck tumors and their     relationship to treatment response and outcome   "
179830|NCT00200057|"     Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel     movement) in order to expel it at a proper time and place. Patients who suffer from FI may     experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a     bowel movement but cannot hold the stool until an acceptable time and place). FI is not a     life-threatening disease, but it is often profoundly distressing and socially incapacitating.      If a patient is suffering with symptoms of chronic FI despite trying oral medications,     biofeedback and/or other more conservative treatments, a patient may be eligible to     participate in a clinical research study to evaluate the safety and effectiveness of sacral     nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120)     patients will be implanted with medical devices and followed closely for twelve months, and     then once a year after that until the study closes. There are up to 20 centers in the United     States.   "
179831|NCT00200070|"     The therapy under investigation involves an implanted Medtronic neurostimulation system to     relieve symptoms of angina pectoris pain. Electrical impulses are applied to targeted areas     of the spinal cord through an implanted lead (a flexible insulated wire) that is powered by     an implanted battery.   "
179832|NCT00200083|"     The purpose of this study is to test the effect of an implanted device that stimulates the     stomach to help obese patients lose weight.   "
179908|NCT00201136|"     This study will test the separate and combined effects of a continuous quality improvement     (CQI) intervention for physicians (MDs) and a behavioral intervention for patients on blood     pressure control.   "
179833|NCT00200096|"     In a previous study, we found that acupuncture may decrease fatigue. The aim of this study is     to determine whether acupuncture is helpful in reducing fatigue in cancer patients treated     with chemotherapy. We will also study how fatigue, quality of life, mood, level of physical     activity. This study will involve about 88 patients.   "
179834|NCT00200109|"     Background: Medically intractable chronic migraine (CM) is a disabling illness characterized     by headache greater than 15 days per month.      Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to     obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM.     Eligible subjects received an occipital nerve block, and responsers were randomized to     adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.   "
179835|NCT00200122|"     The purpose of this study is to characterize the pain coverage capability of the RESTORE     spinal cord stimulation (SCS) and assess health outcomes.   "
179836|NCT00200135|"     The purpose of this study is to find out how many helmeted versus non-helmeted motorcycle     accident victims (MCA) sustain head and/or face injuries. Also, we will find out how much it     costs to get medical care for head and face injuries in helmeted versus non-helmeted     motorcycle victims. Finally, we will compare how long it takes helmeted versus non-helmeted     motorcycle victims with face and head injuries to return to work.   "
179837|NCT00200148|"     With a major liver or pancreas operation, there is a chance that one will require a     transfusion of blood products (either red blood cells or plasma). This may be necessary     during the operation or a few days after surgery. The surgeons at Memorial Sloan-Kettering     Cancer Center perform a very large number of liver or pancreas resections every year and have     pioneered techniques that minimize bleeding during the operation. Even so, liver or pancreas     operations such as the one that will be undergone carry a 50% chance of requiring a     transfusion. A technique that might lower the need for transfusions is called acute     normovolemic hemodilution (ANH). ANH was first introduced over twenty years ago and has been     used in many types of operations, including liver or pancreas resection. The studies done on     ANH at other hospitals suggest that it may help conserve blood. Researchers at Memorial     Sloan-Kettering Cancer Center are conducting a study to determine if ANH is better than the     'standard technique' that is currently used in all patients. The purpose of this study is to     find out which of the two techniques is better.      The purpose of the study is to see if ANH lowers the need for the transfusion of blood     products during and after liver or pancreas resection.      The second purpose of the study is to see how ANH changes the length of the operation, the     length of time one spends in the hospital, and the complication rate after surgery. The     researchers will also see if ANH requires any changes in the administration of anesthesia.   "
179838|NCT00200161|"     Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the     study to see if it is possible to increase the benefit of temozolomide when given after     radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer     when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide     than patients treated with radiotherapy alone. Patients will receive standard low dose     temozolomide during radiation. After radiation, they will be randomized to receive either     more intense temozolomide or continuous low dose temozolomide.   "
179839|NCT00200174|"     The purpose of this research study is to learn about the effects of two drugs when they are     given together. The names of the drugs are raloxifene and exemestane.      Raloxifene is a drug that is related to estrogen. In the liver and bone, it acts like     estrogen. In the breast and uterus it acts like an anti-estrogen. It has been used in     postmenopausal women to prevent a disease called osteoporosis. This is a disease that     decreases bone strength over many years and may finally lead to bone fractures. In a group of     women who were taking the drug, it also seemed to decrease the chances of breast cancer and     possibly endometrial cancer (cancer of the uterus). Therefore, we want to study it further to     see if it prevents breast cancer. We also want to find out if it may be even better in     preventing breast cancer if it is given with another drug.      The other drug in this trial is exemestane. Exemestane is a type of drug that works to     decrease estrogen levels in postmenopausal women. This type of drug is used in women for the     treatment of breast cancer. Before we can decide if the two drugs combined are better for     preventing breast cancer, we must first test these drugs together to make sure that they are     safe. This safety testing is the purpose of this trial.   "
179864|NCT00200499|"     The study was conducted to determine the long-term safety and efficacy of nebivolol in     patients with mild to moderate hypertension. This was an extension of the Phase III dose     ranging studies NEB 202, 302 and 305. Nebivolol was studied as monotherapy and in conjunction     with add-on antihypertensive therapy.   "
179865|NCT00200512|"     The objective of this study was to measure the continued efficacy of apomorphine after     previous exposure of at least three months duration.   "
179866|NCT00200525|"     Study to measure the continued effectiveness of apomorphine after previous exposure of at     least three months duration.   "
179840|NCT00200187|"     You are being asked to join the study because you have early stage prostate cancer and will     have your prostate removed. The purpose of this study is to compare blood loss during surgery     among two types of anesthesia. One type is general anesthesia. It puts you in a deep enough     sleep that you will not feel anything. It also keeps your blood pressure low, which might     decrease bleeding. The second type is combined spinal-epidural anesthesia. For this type, a     small catheter is placed in your spinal canal through your back. Anesthesia given through the     catheter makes your body numb from the waist down, so the sleep you would be in is not so     deep. Your blood pressure would remain in your normal range. After surgery, the catheter     remains in place to treat your pain, but your body would not be numb. When you wake up after     general anesthesia, you would receive pain medicine through a vein in your arm.      Both types are used at Memorial Hospital. They are accepted forms of anesthesia. We will be     looking at blood loss between these two types for patients having their prostate removed. We     also want to learn about the side effects of each anesthesia type, and assess pain that you     experience after surgery.   "
179880|NCT00200707|"     Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can     be used to improve cardiac function in patients after acute myocardial infarction. In this     randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow     cells could improve myocardial viability at 3 and 12 months' follow-up.   "
179841|NCT00200200|"     The purpose of this study is to determine whether the addition of bevacizumab, to hepatic     arterial therapy with floxuridine (FUDR) and dexamethasone (Dex) (regional chemotherapy), and     either oxaliplatin or CPT-11, plus 5-fluorouracil and leucovorin (systemic chemotherapy) will     increase disease free survival in patients who have undergone liver resection. The patient     will be randomized (a computer generated decision as in the flip of a coin) to receive, or     not to receive bevacizumab in addition to regional and systemic chemotherapy.   "
179842|NCT00200213|"     Specific Aims: Environmental factors contributing to overconsumption, such as larger food     portion sizes, may be contributing to the obesity epidemic. The objective of the proposed     study is to examine the independent and combined effects of portion size and quantity of food     on intake in normal weight males and females. Participants will be randomly assigned to one     of four conditions varying in the portion size and quantity of junk food provided: small     quantity of food packaged in small portions (SSP), small quantity of food packaged in large     portions (SLP), large quantity of food packaged in small portions (LSP), and large quantity     of food packaged in large portions (LLP). A box containing four different junk foods,     packaged according to one of the four conditions, will be given to participants to take home     for three days. The total amount of food consumed from the box over the three days will be     measured. It is anticipated that portion size and quantity of food, both independently and     combined, will influence intake, such that larger portion sizes and quantity of food provided     to participants will produce greater intake.Subject Population: We propose to recruit 60     healthy men and women, aged 18-50 years, with a body mass index (BMI) of less than or equal     to 28. Participants will be non-smokers, unrestrained eaters, and have no known food     allergies to the foods used in the investigation.Methods/Design: Participants will be     randomly assigned to one of four conditions, varying in portion size (small versus large) and     quantity of food provided (small versus large). A box containing four junk foods, packaged     according to one of the conditions, will be provided to participants. They will be encouraged     to eat as much or as little of the food as they want, but to at least taste each of the four     foods over the three-day period. During this time, they will be instructed to not eat any     other junk foods. At the end of the three-day period, participants will return the box with     any remaining uneaten junk food.Data Analyses: The dependent variables, the amount of grams     and kcals consumed from the provided junk foods, will be examined between the four different     conditions.Significance: If portion size and quantity are related to intake, subsequent     studies will develop clinical interventions related to reducing portion size and/or quantity     of food available in the household.   "
179843|NCT00200226|"     An endometrial biopsy involves a thin tube being passed through the cervix (opening of the     uterus) to obtain a sample of the lining of the uterus. Sometimes there may be discomfort     with this procedure especially if the cervix is not dilated or opened. Previous research has     suggested that taking a drug called misoprostol may help the cervix to start to dilate or     open. This study will see if misoprostol will help open the cervix for an endometrial biopsy,     to lessen the discomfort and make the biopsy easier to perform.   "
179844|NCT00200239|"     A contributing factor to the rising prevalence of obesity may be increased portion sizes.     However, the effect of portion size has not been studied independent of the effect of     quantity of food in the context of a behavioral weight loss program. Providing pre-portioned     single servings of food may make it easier to reduce caloric and dietary fat intake improving     weight loss. In addition, breakfast skipping is associated with obesity and breakfast     consumption is associated with weight loss success. Therefore, the objective of the proposed     study is to investigate the effect of portion size on consumption of provided breakfast foods     in the context of a behavioral weight loss program. Participants will be randomized to 1 of 2     standard 12-week behavioral obesity interventions. The first intervention, serving as a     control, will provide participants with breakfast foods in non-portioned containers     (Standard). A second intervention will provide participants with the same type and quantity     of breakfast foods but they will be provided in pre-portioned single servings (Portion).     Dependent variables include the number of calories consumed from the provided foods as well     as overall caloric and fat consumption. If the provision of food in pre-portioned servings is     effective at decreasing intake, future directions include conducting longer interventions to     improve long-term weight loss outcomes in standard behavioral interventions.   "
179845|NCT00200252|"     Mothers are given the medication oxytocin after birth to help the uterus (womb) contract and     therefore reduce blood loss. In Canada, oxytocin is given either into the muscle of the thigh     or into a vein. However, it is not known which route is better.This study will test which     dose and route of oxytocin is best in reducing blood loss following vaginal delivery.   "
179846|NCT00200265|"     Recommendations for treatment of childhood obesity in a primary care setting have been     developed. These recommendations include beginning treatment with young children, focusing     treatment on the parent so the parent can assist the child in making changes, and changing 2     or 3 very specific eating or activity behaviors (i.e., eat less snacks, rather than eat less     calories). The effectiveness of these recommendations has never been evaluated. This     project's goal is to develop, implement, and evaluate a 6-month childhood obesity     intervention meeting these recommendations. Another goal of the project is to compare two     different approaches, focusing on either decreasing intake of two unhealthy foods or     increasing intake of two healthy foods, for changing eating behaviors during treatment. Two     hundred ten children, between the ages of 4 to 9 years, who are at risk for overweight or     overweight, based upon weight and height standards, will be randomized to one of three     treatments: 1) a Newsletter treatment (provided with information on healthy eating only); 2)     a Parent Program that decreases intake of sweet/salty snack foods (< 3 servings/week) and     sweetened drinks (< 3 servings/week); or 3) a Parent Program that increases intake of fruits     and vegetables (5 servings/day) and low-fat dairy products (2 servings/day). Children's     height and weight will be measured at 0, 3, 6, 9, and 12 months. This project will determine     if the recommendations for treatment are effective, and if focusing on decreasing intake of     unhealthy foods or increasing intake of healthy foods produces a better long-term weight loss     outcome.   "
179867|NCT00200538|"     The purpose of this trial is to assess the efficacy and tolerability of memantine     (anti-excitotoxic, neuroprotective treatment currently used in Alzheimer's disease [AD]) in     frontotemporal dementia patients after a one-year treatment.   "
179881|NCT00200720|"     This study will examine the effects of a low carbohydrate diet versus a high carbohydrate     diet on weight loss.   "
179882|NCT00200733|"     This study examined the experiences of individuals undergoing acupuncture to gather     information on patient-provider communication and on the therapeutic effects of acupuncture.   "
179883|NCT00200746|"     The purpose of this study is to test the effectiveness of the amino acid arginine in reducing     liver injury in individuals with alcohol-related hepatitis.   "
179884|NCT00200759|"     The purpose of this study is to evaluate the potential of cranberry juice to interact with     conventional drugs. This study will also determine the the amount of cranberry flavonoids     that appear in the blood and in the urine.   "
179909|NCT00201149|"     The purpose of this study is to test the effect of clinician counseling and cultural     competence training on medication compliance and blood pressure (BP) control in patients with     high BP.   "
179847|NCT00200278|"     The objective of this study is to determine the differential effect of intervention delivery     channel (phone versus print versus wait list control) on physical activity adoption and     maintenance in previously sedentary adults. Both delivery channels have been found to be     effective, but telephone-based interventions require more commitment on the part of the     subjects and are more labor intensive than print-based interventions. Thus, we will conduct a     randomized controlled clinical trial comparing three groups: 1) telephone-based     motivationally-tailored individualized feedback; 2) print-based, motivationally-tailored     individualized feedback; 3) minimal contact waiting list control condition (receive     intervention after 12 months as controls). Two hundred and twenty-eight healthy, sedentary     women and men ages 18-65 will be randomly assigned to one of the two interventions or the     waiting-list control condition. Our primary hypothesis is that individuals randomized to     either phone or print conditions will exhibit significantly higher levels of physical     activity participation at 6 and 12 months than individuals in the waiting list control     condition. And, in addition, that subjects randomized to the telephone condition will exhibit     significantly higher levels of physical activity participation at 6 and 12 months than those     in the print condition.   "
179848|NCT00200291|"     The reinforcing value of food, or how much a person wants a food, is an important     determinant of food intake. Thus far, food reinforcement has only been studied in laboratory     settings, and no studies have examined whether the reinforcing value of food is altered when     dietary changes are made. The chronic deprivation that occurs when a low-calorie, low-fat     diet is implemented for weight loss may increase the reinforcing value of all foods, but     particularly for restricted high-fat foods. Greater increases in the reinforcing value of     high-fat foods relative to low-fat foods may be detrimental for sustaining newly adopted     eating behaviors that produce weight loss, whereas greater increases in the reinforcing value     of low-fat foods relative to high-fat foods may aid in maintaining healthy eating behaviors.     The aim of this application is to measure food reinforcement in a clinical setting to     determine if food reinforcement changes when a traditional weight loss diet is prescribed.     For this ancillary study, 147 volunteers will be recruited from the 165 overweight and obese     women participating in the Program to Reduce Incontinence by Diet and Exercise (PRIDE) at The     Miriam Hospital. As part of PRIDE, these participants will be randomized in a 2-to-1 ratio to     either a 6-month weight loss intervention or usual care. Assessments of food reinforcement,     dietary intake, and weight will occur at 0 and 6 months. Given that the intervention group     changes their diet relative to the usual care group, it is hypothesized: 1) the intervention     group will have greater increases in the reinforcing value of both high- and low-fat foods     than the usual care group from 0 to 6 months; and 2) within the intervention group, decreases     in frequency of consumption of high-fat foods will be related to increases in the reinforcing     value of high-fat foods from 0 to 6 months. These results will lead to a novel line of     research, examining the relationship between food reinforcement and weight loss maintenance,     so that diets can be designed to promote changes in food reinforcement that aid in sustaining     dietary changes and weight loss.   "
179849|NCT00200304|"     The Internet has been used effectively in behavioral weight loss programs. Most of these     programs have involved a therapist who provides email counseling. The purpose of this study     was to determine whether a computer-assisted weight loss program could be developed (that     would use pre-programmed computer generated messages rather than human generated messages)     and whether this program would be as effective as the therapist-assisted weight loss program.   "
179850|NCT00200317|"     The purpose of this study is to examine if an individually tailored Internet intervention is     more efficacious than an individually tailored print-based intervention and standard Internet     intervention for physical activity adoption and maintenance among sedentary adults.   "
179851|NCT00200330|"     The obesity epidemic observed in recent years can be largely attributed to an obesogenic     environment that encourages overeating and sedentary lifestyles. Behavioral weight control     treatment, the most empirically validated intervention approach, produces initial weight     losses of 10%; however, maintenance of initial weight loss and behavior change has not been     achieved. These disappointing long-term results may reflect the fact that participants are     given only minimal, indirect instruction on how to change their environment to support their     new weight-regulating behaviors. While in theory, the behavioral model emphasizes     environmental antecedents and consequences of eating and exercise, in practice, only 1 to 2     sessions in standard treatment are dedicated to stimulus control-types of skills. By teaching     weight control skills in a contextual vacuum, participants remain vulnerable to the same     environmental influences that maintained their unhealthy eating and exercise habits. Given     that the majority of eating and exercise is home-based, a logical step in strengthening     behavioral treatment and moving toward an ecological model of behavior is to expand the focus     of treatment from the individual to the individual plus their home environment. We propose to     test the long-term impact of a behavioral weight control program designed to directly modify     both the physical and social home environment of weight loss participants. Two hundred     overweight and obese men and women will be randomly assigned to either 18 months of standard     behavioral treatment (SBT) or 18 months of standard behavioral treatment plus direct     modifications to the home environment (SBT+Home). SBT+Home will incorporate many strategies     that have shown promise in improving weight loss (e.g., food and exercise equipment     provision, spouse involvement) but will be the first to study both physical and social     factors within the home simultaneously and will be the longest examination of the home     environment conducted to date. Participants and spouses will be assessed at baseline, 6, 12,     and 18 months. We hypothesize that by broadening the focus of treatment from the individual     to the individual plus their home environment, SBT+Home will produce both better long-term     weight loss and better maintenance of initial weight loss and behavior change. This home     environmental approach, if successful, has potential applications to the maintenance of other     important health behaviors.   "
179852|NCT00200343|"     This study is a 24-week multicenter, randomized, double-blind control trial with     ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary     objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day     to that of 150mg/day and the safety of UDCA treatment.   "
179853|NCT00200356|"     This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study     on acute ischemic stroke. The primary endpoints were the rate of patients with modified     Rankin Scale score of 0-1 at 3 months.   "
179854|NCT00200369|"     The hypothesis of this study is that the level of adherence necessary to achieve HIV     virologic suppression with a ritonavir boosted protease inhibitor regimen (i.e.     lopinavir/ritonavir) is less than the 95% rate observed in the published literature with     unboosted regimens.   "
179855|NCT00200382|"     The purpose of this study is to develop new treatments that will hopefully result in the     relief of symptoms and prolongation of life. For this reason, your doctors have offered you     treatment with a new experimental drug called PS 341.   "
179856|NCT00200395|"     The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the     treatment of non-small cell lung cancer and to further study its side effects. We would also     like to estimate disease-related symptom improvement rates using a questionnaire.   "
179857|NCT00200408|"     This study will look at the genetic profile of cells taken from the oral cavity of healthy     college students who smoke and who do not smoke cigarettes. This will be done using a small     brush similar to that used in Pap tests for cervical cancer detection. Our aim is to     determine if smoking causes early genetic changes in the DNA of these cells such as have been     seen in the cells of cancerous tumors of the head and neck area and nearby healthy tissues.     This will be correlated with data from subject questionnaires to assess tobacco use, and     other behavior and demographic information.   "
179858|NCT00200421|"     The purpose of this study is to determine the effects on exercise capacity of nebivolol     compared to atenolol in hypertensive patients.   "
179958|NCT00191919|"     To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the     Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment   "
179868|NCT00200551|"     The trial is planned as a multicentric, randomized, prospective, open study in accordance     with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with     chronic renal insufficiency, included in the French national waiting list of the     Establishment Français des Greffes [French Transplants Institution] and receiving a first     renal transplant will be included, after signed agreement, in this study. All the patients     will receive organs taken from brain-dead subjects. The patients will be given     immunosuppressant treatment based on rabbit anti-T lymphocyte serum, CellCeptÒ and NeoralÒ     cyclosporin. One group of 100 randomised patients will be given standard corticosteroid     therapy as well during the first six months following the transplant. This group will be     compared with a second group of 100 randomised patients who will be given a single dose of     corticosteroids. The main aim of this study is to evaluate the number of acute rejection     episodes in patients given a first renal transplant and subjected to an immunosuppressant     protocol not containing corticosteroids. The hypothesis which is proposed is that, in the     absence of corticosteroids and/or calcineurin inhibitors (i.e. cyclosporin and tacrolimus),     antilymphocyte serum results in a certain state of tolerance in respect of the allograft.     The second objective concerns the beneficial effect which the absence of corticosteroids may     have on short- and long-term postoperative morbidity and mortality. One may in fact assume     that the absence of corticosteroids will result in an extension of the transplant patient's     life expectancy as a result of the reduction in cardiovascular complications. Cardiovascular     complications are the most frequent cause of death after a renal transplant.   "
179869|NCT00200564|"     The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in     adults but remains unproved in children. The investigators' purpose is to evaluate the     effects of continuous intravenous small doses of ketamine versus placebo to improve the     quality of postoperative analgesia in children (6 months to 6 years of age). Caudal     anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a     non-steroidal anti-inflammatory and continuous intravenous nalbuphine.   "
179870|NCT00200577|"     The objective of this multicentric Phase III study is to confirm the results of the phase     I-II study (Dreno B & Al. Cancer Immunol Immunother 2002; 51: 539-456) which demonstrated the     preventive effect of a treatment by TIL (Tumor Infiltrating Lymphocytes) combined with IL2     (Interleukin 2; low dose injected subcutaneously) on the metastatic relapse in the stage III     melanoma patients with only one invaded lymphnode.   "
179871|NCT00200590|"     This is a randomised trial comparing the efficacy of 3 different analgesic strategies in     newborns on prostaglandin for ductus dependent congenital heart disease.   "
179872|NCT00200603|"     The aim of the study is to compare radiological behavior of blocks of macroporous     phosphocalcium as bone substitute in comparison with iliac crest autograft in tibial valgus     osteotomy.   "
179873|NCT00200616|"     Randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial     prophylaxis in children with isolated vesico-ureteral reflux (grade III or less).   "
179874|NCT00200629|"     The purpose of this study is to compare the 2-year cardiac outcomes for women with limited     exercise capability based on the resuls of either pharmacological stress myocardial perfusion     imaging or a combined protocol that incorporates both exercise and pharmacological stress.     The goal of the study is to compare these two methods for patient tolerability, safety and     prognostic value   "
179875|NCT00200642|"     Gastroesophageal reflux disease is a frequent disease and which heavily affects the patients'     quality of life. To alleviate symptoms and ease the healing of lesion, patients very often     need to continuously take anti-secretory drugs (Proton pump inhibitors or PPIs), which,     despite their efficiency, do not cure the disease. For these PPI dependent patients, an     anti-reflux surgery (fundoplication often made by coelioscopy) is a possible alternative but     it has a significant morbidity rate and even an estimated post-operative mortality of 0.8%     outside of expertise centres. Therefore, new therapeutic endoscopic approaches, supposed to     be less invasive and less expensive than surgery have been developed during the last three     years. Among them, radiofrequency (Stretta® procedure) consists in administering a high     frequency current in the cardia area, in order to induce thanks to a thermal effect a     sub-mucous remodelling and a modification of the compliance of the cardia regionThe aim of     this project carried out in 8 French centres and 2 European centers is to assess through a     randomised trial, the efficiency of radiofrequency on PPI dependent patients. The study will     be carried out in 2 phases with patients who have been fully informed of the project     statement, and particularly of the potential risks of the radiofrequency technique and have     given their written acceptation to participate to the study.The first phase, which will last     6 to 11 weeks, will aim at making sure that patients are PPI dependent and define their     needs. After this initial phase, patients will be randomised between those who will carry on     with the PPI treatment or the radiofrequency treatment. The follow up after this     randomisation will last one year. The first assessment of the therapeutic efficiency will be     done at 6th month. The 6 additional follow up months will be required for the assessment of     mid-term side effects of the treatment and the rate of symptomatic recurrences.   "
179876|NCT00200655|"     Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of     immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is     quite limited, they are not well tolerated and they have a very high cost. Recent works     showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called statins).     In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and     progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in     vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the     blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was     associated with a decreased lesional activity assessed by MRI. Statins are well tolerated     drugs, used for many years, with a low cost and with a putative efficacy in MS. The     investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a     double-blind, placebo-controlled study in 40 patients with a relapsing-remitting MS.   "
179877|NCT00200668|"     Comparison between FDG-PET and MRI for the assessment of response to intensive chemotherapy     in multiple myeloma patients.   "
179878|NCT00200681|"     This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480     patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously     treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment     plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by     autograft as first-line therapy, as the investigators try to compare the complete remission     (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.   "
179879|NCT00200694|"     Determine the best strategy for proteinuria lowering in patients with proteinuria > 1 g/day     receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of     diuretic dosage.   "
179885|NCT00200785|"     This study will seek to identify the compound(s) in garlic that is (are) responsible for its     ability to prevent the formation of blood clots (prevent platelet aggregation) and to     determine the maximally effective dose and duration of the benefits. This study will also     determine whether cooked garlic (garlic powder added to boiling water, no allicin present)     is as effective as fresh garlic (garlic powder added to ambient water, high allicin     present) and, if more than one compound is involved, and whether their combined effects are     more significant than the effects of each compound alone.   "
179886|NCT00200798|"     There is accumulating evidence from various sources that extracts from the milk thistle plant     can be useful in the treatment of a variety of liver ailments as well as other disorders.     This investigation will essentially be composed of two individual normal volunteer studies of     milk thistle. The first study will assess the rate and extent of absorption of components of     a standardized botanical extract obtained from the milk thistle plant. This first study is     termed a bioavailability study. This investigation will take approximately 8 weeks and     involve 10 clinic visits. Secondly, a drug interaction study will be performed. This is an     assessment study of the potential for this botanical extract to interact with other     prescription or over-the-counter medications. This study is also expected to take     approximately 8 weeks but will involve 18 clinic visits. In both studies all subjects will     receive the same milk thistle supplement and no placebo will be administered.   "
179887|NCT00200824|"     This study will determine the effects of soy products on in vitro surrogate cancer markers as     well as bone density markers and quality of life parameters in men and women. This study will     also determine concentrations of isoflavones (naturally occurring plant compounds that act     like estrogen in the body) in prostate tissue that has been removed during prostatectomy, as     well as in the blood.   "
179888|NCT00200837|"     These are ethnomedicine studies of plants used by rural and indigenous peoples for pain and     oral inflammation relief.   "
179889|NCT00200850|"     This study will investigate sublingual immunotherapy (SLIT), a treatment involving antigens     placement under the tongue to help asthma sufferers build a tolerance to the allergy-causing     substances. Specifically, this study will determine the effectiveness of SLIT at two     different dosing regimens for patients with intermittent mild asthma caused by dust mites.   "
179890|NCT00200863|"     This study will determine which color of light is most effective in stimulating a range of     biological functions in humans including activation of sleep-wake regulatory system     (alertness, performance, microsleeps, brain activity), activation of the nervous system     (heart rate, temperature, blood pressure, breathing rate), and shifting the timing of the     internal 24-hour (circadian) pacemaker.   "
179891|NCT00200876|"     This study will use brain imaging technology to examine chemical systems in the brain that     suppress pain and stress when an individual has an expectation of pain relief.   "
179892|NCT00200889|"     This study will determine how acupuncture affects human brain activity.   "
179893|NCT00200902|"     This study will use measurements of depression symptoms and brain activity to determine what     factors may influence an individual's response to treatment for depression.   "
179894|NCT00200928|"     The degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and     related to the degree of inhibition of TH2-mediated disease.   "
179895|NCT00200941|"     This study is intended to determine whether topiramate is an efficacious and safe treatment     for restless legs syndrome.   "
179896|NCT00200954|"     Administration of probiotics to pregnant women from an atopic family and subsequently to     their high-risk newborns results in prevention of the incidence or in a decrease of the     severity of atopic disease during infancy.   "
179897|NCT00200967|"     The purpose of this trial is to determine whether regularly scheduled use of an inhaled     long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled     corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental     effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic     receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly     genotype.   "
179898|NCT00200980|"     The purpose of the study is to follow the medical course of children with moderate to severe     asthma and see how this relates to whether they have acid of non-acid gastroesophageal reflux   "
179899|NCT00200993|"     To investigate the separate effects of the amount of exercise and exercise intensity on     cardiovascular risk factors in overweight men and women with mild to moderate dyslipidemia.   "
179900|NCT00201006|"     To test the effectiveness of interventions designed to promote long-term weight management of     obese women in medically underserved rural counties.   "
179901|NCT00201019|"     The purpose of this study is to evaluate the impact of physician/pharmacist collaborative     teams on hypertension guideline adherence for patients with uncontrolled hypertension in six     family medicine practice sites in Iowa.   "
179902|NCT00201045|"     The purpose of this study is to test whether blood pressure control can be improved by     physician education and feedback provided through the development of physician/pharmacist     collaborative teams.   "
188669|NCT00321035|"     The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix is     effective and safe to implant as an aid of glaucoma and pterygium surgeries.   "
179903|NCT00201058|"     The purpose of this project is to refine and further evaluate an online asthma management and     education program for urban teenagers. This project is a continuation of Puff City I, a     project piloting and evaluating a tailored, school-based, computerized asthma education     program for urban teenagers. In this second phase of research, a new version of software     (Puff City II) will be created that will target resistance to change and relapse, and using a     tested, theory-based approach to student recruitment, conduct a randomized trial to test the     efficacy of this new software.   "
179904|NCT00201071|"     The purpose of this study is to test the effectiveness of a bilingual intervention in     improving asthma care for low-income inner-city children enrolled in subsidized preschool     childcare programs.   "
179905|NCT00201084|"     The purpose of this study is to test the theory that a major factor in poor blood pressure     (BP) control is that physicians fail to intensify antihypertensive therapy for their     patients.   "
179910|NCT00201162|"     To determine the effects of soy on lipids, lipoproteins and lipoprotein subclass in a sample     of African-American and white postmenopausal women with low-density lipoprotein (LDL)     cholesterol elevations that may increase their lifetime risk for cardiovascular disease but     would not qualify for definite pharmacotherapy under current guidelines.   "
179911|NCT00201188|"     The purpose of this study is to improve anti-inflammatory medication adherence and asthma     outcomes by using reports of peak flow monitoring to prompt communication between patients     and their doctors.   "
179912|NCT00201201|"     The purpose of this study is to reduce adverse self-medication practices in older adults with     hypertension.   "
179913|NCT00201214|"     This study will determine the pharmacokinetics and safety of intravenous citrulline given to     children undergoing cardiopulmonary bypass for the correction of congenital heart defects.   "
179914|NCT00201227|"     To evaluate whether the innovative multimethod assessment process/participatory quality     improvement (MAP/PQI) intervention increases adherence to multiple cardiorespiratory     guidelines in primary care practice.   "
179915|NCT00201240|"     This study is a single arm Phase II, multicenter trial. It is designed to determine whether     the anticipated endpoints for a T cell depleted transplant arm of a planned prospective     randomized trial comparing T cell depleted and unmodified hematopoietic allografts are likely     to be achieved in a multicenter study conducted by the Blood and Marrow Transplant Clinical     Trials Network (BMT CTN or Network). The study population is patients with acute myeloid     leukemia (AML) in first or second morphologic complete remission. The enrollment is 45     patients.      Based on published results of unmodified transplants from HLA-matched siblings applied to     patients with AML in first or second morphologic complete remission, a significant     improvement in results with a graft modified as specified in this protocol would be expected     if disease-free survival (DFS) at 6 months was greater than 75%, the true incidence of     transplant-related mortality at 1 year was less than 30%, and the DFS rate at 2 years was     greater 70% for patients transplanted in first remission and less than 60% for patients     transplanted in second remission. Additional secondary endpoints include the following: graft     failure rate and incidences of acute grade II-IV and chronic graft-versus-host disease     (GVHD). Additionally, the trial will have target specific doses of CD34+ progenitors and CD3+     T cells to be obtained following fractionation with the CliniMACS system. Based on the     results of this trial, a Phase III trial comparing T cell depleted peripheral blood stem cell     transplants (PBSCT) with unmanipulated bone marrow or unmanipulated PBSCT will be designed.   "
179916|NCT00201253|"     The purpose of this study is to assess lung immune responses in patients with active     pulmonary tuberculosis (TB) and in healthy control persons who are exposed to Mycobacterium     tuberculosis in households of patients with TB or who are unexposed.   "
179917|NCT00201266|"     This study will evaluate the link between blood group antigens and asthma exacerbations.   "
179918|NCT00201279|"     The purpose of this study is to study the effect of 13-cis retinoic acid in preventing second     primary malignancy in the oral cavity cancer patients after curative local treatment and to     study the toxicity and compliance of 13-cis retinoic acid.   "
179919|NCT00201292|"     Diabetes is prevalent in schizophrenics and may be induced by antipsychotic treatments.     Several retrospective studies have suggested that psychiatric patients exposed to atypical     antipsychotics may be at a higher risk for developing diabetes and ketoacidosis. The     association between these atypical antipsychotics and the onset of diabetes is further     strengthened by observations of:        1. the time sequence between the initiation of antipsychotic treatment and the onset of          diabetes;        2. remission after the discontinuation of medications; and        3. re-emergence of diabetes following the re-introduction of atypical antipsychotics.      The treatment emergent diabetes, along with other metabolic disturbances, represents a     serious issue in the use of atypical antipsychotics. Major current debates and unresolved     research issues which are also the focus of this proposal, are:        1. schizophrenia per se, versus the use of antipsychotics, in triggering diabetes;        2. whether there are differences between typicals and atypicals in such an effect;        3. whether there are differences among different atypicals;        4. whether, and to what extent, treatment emergent diabetes may be associated with, or          independent of, weight gain, which also often is associated with the use of          antipsychotics; and        5. genetic and environmental risks in association with treatment emergent diabetes.      The policy of some hospitals in Taiwan that discourages the use of atypical antipsychotics     for new onset schizophrenia directs the investigators to a study design looking at the     associated diabetes of both types of antipsychotics. Such a design may provide some hints to     the unresolved research issues mentioned above.      Meanwhile, a broader defined term, X-syndrome, or metabolic syndrome, is being used to     describe the diabetic condition associated with antipsychotics. X-syndrome is a risky     condition leading to cardiovascular diseases and diabetes, with insulin resistance as the     major outcome, associated with two of the following conditions: truncal obesity (deposited in     the thorax and abdomen, instead of the hips and thighs), high triglycerides, high low-density     lipoprotein (LDL) cholesterol or hypertension. The proposed study will combine the phenotypes     of diabetes and X-syndrome to explore the abnormal metabolism caused by antipsychotics,     bridge important information gaps, and provide data contributing towards a better     understanding of the risk and management of diabetes and X-syndrome associated with the use     of antipsychotics. Three assessment tools, namely the Clinical Global Severity (Clinical     Global Impressions - Severity) or the Positive and Negative Symptom Scale (PANNS), the     Diabetes Risk Assessment (ADA) and the Life Style Survey, together with physical     measurements, collect additional information for this study. Diabetes related biochemistry,     including glucose, insulin, leptin, lipids and glycohemoglobin, will be measured to form a     composite phenotype for further pharmacogenetic studies. Candidate genes involved in     pancreatic beta cell insulin secretion will be examined in priority to see if they play a     role in the development of the antipsychotics-induced diabetes.   "
179920|NCT00201305|"     This is an open-label phase II trial with weekly gemcitabine plus high-dose 5-FU/leucovorin     infusion (HDFL) for patients with advanced or metastatic carcinoma of the biliary tract. The     primary endpoint is patients' response and the secondary endpoints are chemotherapy-related     toxicity, time to disease progression and overall survival. .   "
179921|NCT00201318|"     * AIMS OF THE STUDY (STUDY OBJECTIVES)        1. To test the effect of daily lamivudine (100 mg) in reducing the risk of HBV reactivation          and hepatitis development in HBsAg (+) NHL patients.        2. To test the efficacy of daily lamivudine in preventing and treating hepatitis B          reactivation and in circumventing hepatic failure and death.        3. To test whether lamivudine can improve the overall outcome of NHL patients who are HBV          carriers.      (Study end-points: The major end-point: hepatitis B reactivation in NHL patients---defined by     higher than 10-fold increase of serum HBV DNA level and/or reappearance of HBeAg in the serum     during and within 6 months after chemotherapy. The minor end-point I : events of hepatic     failure and death---defined by jaundice with hepatic encephalopathy. The minor end-point II:     the response rate and survival rate in HBsAg-positive NHL patients receiving lamivudine     prophylaxis and treatment.)   "
179972|NCT00192127|"     This study is to assess the safety of a bivalent vaccine of two new 6:2 influenza virus     reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist)     containing them.   "
179922|NCT00201331|"     Based on the astonishing high response rate in metastatic colorectal cancer in weekly high     dose 5-FU and leucovorin, we will conduct a clinical trial to clarify the activity of this     regimen in the adjuvant setting. The regimen of 5-FU and high dose leucovorin administered as     the schedule of INT-0089 will be chosen as the controlled arm which was proven as effective     as standard 5-FU plus levamisole regimen with short duration of treatment.21 In this study,     continuous infusion of 5-FU (HDFL, Arm B) and bolus injection of 5-FU (Arm A) will be     administered to the high risk colon cancer(N2 disease) patients. The role of TS level and     inhibition of TS as a predictor of adjuvant chemotherapy with 5-FU based treatment will be     clearly defined prospectively.   "
179923|NCT00201344|"     -  To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs          radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of          the study includes : overall survival, relapse free survival, distant metastasis and          local-regional control rates.        -  To evaluate the toxicities of the two treatment methods.   "
179924|NCT00201357|"     Trial objectives: The primary objective is to determine the proportion of patients who have     50% decrease in PSA maintained for at least 4 weeks, in advanced hormone-refractory prostate     cancer (HRPC) patients who receive thalidomide (100 mg BID). Secondary objectives include the     objective tumor response rate for measurable lesions, the median duration of tumor response,     median time to disease progression and assessments of clinical benefits, quality of life, and     safety profile.   "
180126|NCT00194142|"     The purpose of this study is to determine if detection of cytomegalovirus (CMV) in amniotic     fluid collected in the second trimester of pregnancy is associated with pregnancy     complications such as preterm delivery or severe preeclampsia.   "
179925|NCT00201370|"     The aims of this study are:        1. Surveillance of the prevalence of HPV infection in ASCUS, AGCUS and SIL cases pooled          from medical centers in Taiwan and analysis of the related epidemiological factors.        2. Providing a better understanding of the natural history of HPV infection with its          correlation with pathologic changes through a longitudinal follow-up of LSIL cases.   "
179926|NCT00201383|"     The purpose of this study is to confirm the value of concurrent chemoradiotherapy in     improving the locoregional control and survival of patients with resected locally advanced     HNSCC, a phase III randomized study is proposed. The population studied in this trial is     limited to patients of oral cavity cancer; this could reduce the confounding factor of     varying prognosis in patients of different primary sites of HNSCC.   "
179927|NCT00201396|"     Investigate the effect of induction MEPFL chemotherapy followed by concurrent     chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with     advanced NPC.   "
179928|NCT00201409|"     This study will test the hypothesis that administration of granulocyte-macrophage colony     stimulating factor (GM-CSF) to patients with acute lung injury/acute respiratory distress     syndrome (ALI/ARDS) will improve the clinical course and outcome by shortening the duration     of mechanical ventilation for these patients.   "
179929|NCT00201422|"     To evaluate the therapeutic effectiveness of H. pylori eradication in stage IE & IIE-1     primary low-grade B cell lymphoma of MALT of the stomach   "
179930|NCT00185120|"     A comparison of 2 different combinations of high blood pressure medications to treat     hypertension   "
179931|NCT00185133|"     This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus     amlodipine in mild to severe hypertensive patients older than 18 years of age   "
179932|NCT00185146|"     The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be     assessed using carotid ultrasound   "
179933|NCT00185159|"     This is a study in diabetic patients with at least one additional cardiovascular risk factor     and normoalbuminuria prior to randomization.   "
179934|NCT00185172|"     To test the efficacy and safety of olmesartan in patients with essential hypertension.   "
179935|NCT00185185|"     This is a study in hypertensive patients with atherosclerosis and increased cardiovascular     risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.   "
179936|NCT00185198|"     The purpose of this study is to investigate the effect of a testosterone replacement therapy     called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and     other symptoms of PADAM and safety will be studied.   "
179937|NCT00185211|"     This study will primarily compare the long-term effects of an early and continued treatment     with Betaferon/Betaseron (patients who were treated with active medication during the     double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple     Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with     placebo during the double-blind BENEFIT study).      Analyses are based on the integrated data of the initial BENEFIT study and this follow-up     study.   "
179938|NCT00185224|"     The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma     lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic     parameter following the long term administration of SH T00658ID will be assessed.   "
179939|NCT00185237|"     150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and     exclusion criteria will be enrolled in the study. The women will be randomly assigned to one     of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch     once a week for 12 weeks.   "
179940|NCT00191672|"     The combination of docetaxel and gemcitabine has shown significant activity in patients with     metastatic breast cancer. Several studies have activity in patients of multiple lines of     therapy, including patients that have been treated with prior taxane therapy. Overall     responses have ranged from 30% to 79%. The major side effects of the combination chemotherapy     have been neutropenia, anemia, asthenia, neuropathy, nausea, mucositis, and neutropenic fever   "
179941|NCT00191685|"     The purpose of this study is to determine the optimal treatment strategy for MDD patients     with melancholic features who do not respond to a standard daily dose. This study will allow     investigators to mimic standard clinical practice. During the first 2 weeks of treatment,     clinical evaluation of individual patient tolerability and efficacy will enable the dose of     duloxetine to be adjusted. Patients allocated to the Flex group may have their daily dose of     duloxetine adjusted in the attempt to elicit a clinical response.   "
179942|NCT00191698|"     The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of     ODD in children with ADHD and ODD.   "
179995|NCT00192426|"     Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when     administered concomitantly with CAIV-T to healthy children.   "
179943|NCT00191711|"     The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is     enough active in patients with a solitary, low risk superficial bladder cancer.After     diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical     gemcitabine once a week during 6 weeks. Two weeks after finishing antiblastic therapy, all     patients will be submitted to a new cystoscopy, with TUR or cold biopsies of the site of the     initial lesion.   "
179944|NCT00191724|"     An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation     study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a     combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.   "
179945|NCT00191737|"     A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and     tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by     patients, parents and physicians, and its impact on self-esteem in adolescents (aged 12     through 17 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in     Germany. An 8-week treatment phase is followed by a 16-week extension period.   "
179946|NCT00191750|"     The purposes of this study are to determine 1) the safety of pemetrexed and any side effects     that might be associated with it 2) whether pemetrexed can help patients with small cell lung     cancer live longer 3) whether pemetrexed can make tumors smaller or disappear and for how     long and 4) to see if patients feel better while taking pemetrexed   "
179947|NCT00191763|"     Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for     patients with resectable non-small cell lung cancer. The exploration of new drugs and     regimens are warranted. Therefore the aim of this study is to evaluate the clinical response     rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable     non-small cell lung cancer stage IB, IIA-B, IIIA.   "
179948|NCT00191789|"     Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant     chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and     cisplatin, also a highly active combination in this indication, may result in improvement in     pathological response and overall survival. Patients with operable breast cancer will be     treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine     plus cisplatin.   "
179949|NCT00191802|"     The purposes of this study are to evaluate the acceptance of the subcutaneous drug     teriparatide over 6 months of therapy in patients with severe osteoporosis in Canada, and to     evaluate how often such patients are actually able to use the injection; to obtain additional     safety data (side effect data) that will supplement the existing database of adverse events     that have been reported to-date in clinical trials by patients treated with teriparatide; to     document the prior use of other osteoporosis therapies in this patient population, and     ongoing use of other osteoporosis therapies during the study; and to describe the baseline     demographics and disease state of these severely osteoporotic patients.The purposes of the     study extension are to continue to assess the acceptance of the subcutaneous drug     teriparatide over up to 18 months of therapy in patients with severe osteoporosis in Canada,     and to continue to assess how often such patients are actually able to use the injection; to     obtain additional safety data (side effects) that will supplement the existing database of     adverse events that have been reported to date in clinical trials by patients treated with     teriparatide.   "
179950|NCT00191815|"     The purpose of this study is to determine the objective tumor response of the first-line     therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer   "
179951|NCT00191828|"     Olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia     and moderate to severe manic episode.      Olanzapine is among the many antipsychotic agents associated with weight gain . The mechanism     for antipsychotic drug-related weight gain is not known, although antagonism of serotonin     receptors, especially the 5HT2C , and histamine receptors has been hypothesized.      The purpose of this study is to observe the efficacy of a psychoeducational programme in     managing the increased weight as a side effect of the olanzapine treatment.      Interventions to prevent weight gain associated with olanzapine should at least include     periodic monitoring and recommendations for changes in diet and physical activity.      This is a phase IV, randomised, parallel study of subjects previously treated with olanzapine     as antipsychotic monotherapy, which have shown an increase of B.M.I. >7% from the beginning     of antipsychotic treatment (assessed during the routine visits). For the first 12 weeks of     the trial approximately 60 outpatients, enrolled in one site during a period of one year,     will be randomised in a 1:1 ratio into 2 treatment groups: olanzapine + psychoeducational     programme or olanzapine alone. In the following 12 weeks of the study all patients undergo     the psychoeducational programme. The efficacy of this programme will be assessed monitoring     the mean difference from baseline to endpoint in total body weight and BMI.   "
179952|NCT00191841|"     To evaluate the clinical response rate of neoadjuvant chemotherapy with gemcitabine and     cisplatin in patients with operable NSCLC   "
179953|NCT00191854|"     The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the     treatments of MBC; however, the optimal dosing schedules for these combinations have not yet     been determined. The primary objective of this study is to compare the response rates of the     gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when     administered on a biweekly schedule in metastatic breast cancer.   "
179954|NCT00191867|"     The purpose of this study is to assess the Efficacy and Safety of Teriparatide in Japanese     Postmenopausal Women with Osteoporosis.   "
179955|NCT00191880|"     Open-label trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 years with     Attention- Deficit/Hyperactivity Disorder   "
179956|NCT00191893|"     The purpose of this study is to assess the effect of 24 months of treatment with once daily     teriparatide injection (recombinant human PTH [1-34]) 20 micrograms on bone histomorphometry     and architecture. Patients will include postmenopausal, osteoporotic women who have been     treated long term (at least 36 months) with alendronate, as well as postmenopausal,     osteoporotic women who have never been treated for osteoporosis.   "
179957|NCT00191906|"     To test the hypothesis that a 4 week treatment with atomoxetine is more effective than     placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD),     patients with only Reading Disorder, and patients with combined type ADHD and Reading     Disorder.   "
179959|NCT00191932|"     A multicentre, randomised, open label study of out-patients with major depression who have     failed to respond adequately to antidepressant treatment for their current episode of     depression. The study compares outcomes associated with two methods of switching from current     antidepressant to duloxetine   "
179960|NCT00191945|"     Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with     recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1).     The double blinded period will last 12 weeks and the treatment open phase will last up to 1     year, and atomoxetine treatment will be administered.      A gatekeeper strategy will be employed for sequentially testing the secondary objectives.   "
179961|NCT00191971|"     To investigate efficacy and safety of 2nd line GEM monotherapy after CDDP regimen for     patients with transitional cell carcinoma of urothelium   "
179962|NCT00191984|"     A non-randomized phase II study to determine the efficacy and safety of the combination of     Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.   "
179963|NCT00191997|"     This is a randomized, parallel, open-label study of patients who have responded to treatment     in the acute phase of their manic or mixed episode, with or without psychotic symptoms, with     olanzapine in mono or co-therapy, and who are in syndromic and symptomatic remission at the     time of enrollment into the study.   "
179964|NCT00192023|"     The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric     patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD).     The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and     ODD symptoms in patients non responders to a previous psychological intervention with parent     support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid     conditions associated with ADHD and ODD will be assessed.   "
179965|NCT00192036|"     The purpose of the study is to evaluate the response rate of patients with non small lung     cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this     combination will also be evaluated.   "
179966|NCT00192049|"     Gemcitabine has been shown to be highly effective and well tolerated in the first and second     line therapy, as a single agent or in combination therapy for treatment of metastatic     transitional cell carcinoma. On the basis of Gemcitabine clinical activity and good     tolerability this drug has been recently tested in intravesical therapy. we consider     Gemcitabine as a good therapy candidate for patient with intermediate risk superficial     bladder cancer. Based on the phase I/II clinical trials w are going to explore the efficacy     and tolerability of Gemcitabine in this setting, and compare it to Mitomycin C which is     widely used in this group of patients.   "
179967|NCT00192062|"     This is a Phase II study of gemcitabine- Vinorelbine combination in a 3-weekly schedule as     first line chemotherapy in patients with metastatic breast cancer. Eighty patients with     measurable disease will be enrolled in the study. Gemcitabine will be used at 1000 mg/m2,     vinorelbine at 25mg/m2. Every cycle, vinorelbine will be administered before gemcitabine.     After the initial dose, modifications of Gemcitabine and vinorelbine doses are allowed based     on patient toxicity      Study therapy may continue until:        -  There is evidence of progressive disease        -  The patient experiences unacceptable toxicity.        -  The investigator decides that the patient should be discontinued        -  The patient requests discontinuation        -  The patient has received 6 cycles of the regimen(if the physician decides to continue          after 6 cycles-this will be done after consultation with the sponsor)        -  Discontinuation from study therapy is indicated according to the protocol It's the          investigator's responsibility to strictly stick to the protocol procedures. It needs to          be discussed with Lilly medical designee in advance when any special situation occurs          which has not been defined in protocol.      After patients discontinue from study therapy, they proceed to the post-study follow up phase     of the study. Assessments to take place during this phase are outlined in the protocol.   "
179968|NCT00192075|"     The purpose of the study is to describe the tumor response rates for the two regimens being     studied, and to determine how long patients live after receiving the treatment, how long     patients are without return of their disease after they receive treatment, and how long the     response they get from the treatment lasts. The amount and type of side effects/toxicities of     each regimen will also be evaluated. The regimen including Oxaliplatin + 5FU/Folinic Acid is     a current standard of care.   "
179969|NCT00192088|"     Open label single arm phase II study of Pemetrexed plus Oxaliplatin in patients with advanced     gastric carcinoma not previously treated with palliative chemotherapy. 43 Patients will be     enrolled in this local trial. The primary objective of this study is to determine the     response rate of the treatment.Schedule for this study is as follows: 6 cycles/21 days of     Pemetrexed 500 mg/m2 followed by Oxaliplatin 120 mg/m2. This study will also include     pharmacogenomic and pharmacogenetic investigations in order to assess determinants of     efficacy and toxicity of the treatment with Pemetrexed and Oxaliplatin in the study     population.   "
179970|NCT00192101|"     This is an open label, two arms, randomized, unblinded phase 2 study in patients with locally     advanced or metastatic breast cancer who have been previously treated with anthracycline     with/without taxane based regimen in the adjuvant/neoadjuvant or 1st line metastatic setting.     Gemcitabine will be administered via intravenous infusion over approximately 30 minutes at a     dose of 1250mg/m2 on days 1 and 8 of each 21-day cycle. In arm A:Cisplatin will be given via     intravenous infusion over approximately 60-120 minutes at a dose of 70 mg/m2 on Day 1 of each     21-day cycle. The investigator may attempt to give Cisplatin with at least one liter of     fluids for hydration and on an outpatient basis.      Patients will remain in the study until disease progression or when a maximum of six cycles     have been administered. Study therapy may continue until:        -  There is evidence of progressive disease        -  The patient experiences unacceptable toxicity.        -  The investigator decides that the patient should be discontinued.        -  The patient requests discontinuation        -  The patient has received 6 cycles of the regimen (if the physician decides to continue          after 6 cycles-this will be done after consultation with the sponsor)        -  Discontinuation from study therapy is indicated according to the additional guidelines          described in the protocol After patients discontinue from study therapy, they proceed to          the post-study follow up phase of the study.   "
179971|NCT00192114|"     Enzastaurin given daily to patients with colorectal cancer who have Stage 4 disease and have     not received prior chemotherapy for advanced colorectal cancer   "
179973|NCT00192140|"     -  To describe the proportion of individuals 5-49 years of age who shed vaccine strain          viruses.        -  To describe the duration of shedding of vaccine viruses in individuals 5-49 years of          age.        -  To describe the genotypic and phenotypic stability of shed vaccine viruses.        -  To describe the immune responses of FluMist in individuals 5-49 years of age.        -  To describe the safety of FluMist in individuals 5-49 years of age in relation to          shedding and the immune response   "
179974|NCT00192153|"     The purpose of this clinical study was to evaluate immune responses measuring antibodies in     serum and secretions and cellular immune responses generated by CAIV-T vaccine in healthy     adults aged 18 years and older as a means to develop assays for application in investigating     potential immunological correlates of protection and/or establishing assays to measure     vaccine take.   "
179975|NCT00192166|"     - The primary objective of the study was to determine if intranasally administered influenza     virus vaccine, CAIV-T), when administered concomitantly with a subcutaneously administered     combination live, attenuated mumps, measles, and rubella (MMR) virus vaccine to children     interferes with the immune responses.   "
179976|NCT00192179|"     A safety study to compare, over a 7 day period, the fever rates following one dose of either     Influenza Virus Vaccine or placebo administered outside the influenza season to healthy     children and adolescents aged 6 to less than 18 years.   "
179977|NCT00192192|"     To perform a variety of assays on blood, serum, nasal wash samples and cells obtained from     healthy adult subjects for the purposes of developing assays for application in the further     investigation of immune responses generated by influenza virus vaccine, trivalent, types A     and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA).   "
179978|NCT00192205|"     - Trial to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture     confirmed influenza illness in children.   "
179979|NCT00192218|"     To measure the effectiveness of influenza vaccination in school children by comparing,     between target(i.e., children are offered FluMist) and control (i.e., children are not     offered FluMist) school families.   "
179980|NCT00192231|"     The primary objective of this study was to perform a variety of immunological assays on     blood, serum, nasal wash samples, and cells obtained from healthy adult subjects for the     purpose of developing assays for application in the further investigation of immune responses     generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid     CAIV-T).   "
179981|NCT00192244|"     - The purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian     population aged from 6 months to less than 36 months, in tropical and temperate climates,     against culture-confirmed influenza illness. In addition, the trial provides the opportunity     to investigate the efficacy of CAIV-T over multiple influenza seasons, and to investigate the     effect of CAIV-T on acute otitis media.   "
179982|NCT00192257|"     - Trial to assess asthma exacerbation through to the end of the study; and to demonstrate     that the efficacy over one season against culture-confirmed influenza-illness; and finally to     assess the safety and tolerability of CAIV-T in children with asthma.   "
179983|NCT00192270|"     The study was designed to determine the number of doses of CAIV-T required to effectively     immunize children and adolescents in the 6 to 17 year age group.   "
179984|NCT00192283|"     The purpose of this study is to determine the efficacy of the liquid formulation of CAIVT     against culture confirmed influenza illness in healthy children aged at least 6 months and     less than 36 months, attending day care centers in Europe. In addition, the trial provides     the opportunity to investigate the effect of CAIV-T on acute otitis media, on healthcare     resource utilization and economic resources.   "
179985|NCT00192296|"     Phase I study to evaluate the safety and tolerability of escalating single IV doses of     MEDI-528.   "
179986|NCT00192309|"     The primary objective of this study was to perform a variety of assays on blood, serum, nasal     wash and cell samples obtained from healthy adult subjects for the purposes of developing     assays for application in the further investigation of immune responses generated by     influenza virus vaccine, trivalent, types A & B, live, cold-adapted (liquid formulation     CAIV-T; Wyeth, Marietta, PA).   "
179987|NCT00192322|"     To perform a variety of assays on blood, nasal washes, and cells obtained from healthy     children for the purposes of further investigation of immune responses generated by influenza     virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle     Vaccines, Marietta, PA).      • To assess nasal swab specimens to detect vaccine virus shedding.   "
179988|NCT00192335|"     -  Primary objective is to demonstrate equivalent immunogeniticity of CAIV-T and FluMist        -  Secondary objective of this study is to assess the safety and tolerability of CAIV-T          compared to FluMist   "
179989|NCT00192348|"     Trial to compare the safety and tolerability of one and two doses of influenza virus vaccine.   "
179990|NCT00192361|"     To assess whether CAIV-T was transmitted from vaccinated children to their unvaccinated     contacts in a day care setting; and if so, to estimate the rate of transmission.   "
179991|NCT00192374|"     - Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels     of a Liquid Formulation of(CAIV-T) in Healthy Children.   "
179992|NCT00192387|"     The primary objective of this study was to determine the proportion of subjects, seronegative     to all three strains of influenza, as defined by a serum hemagglutination inhibition     antibodies (HAI) antibody titer of <1:10, who shed each vaccine virus strain following a     single dose of CAIV-T.   "
179993|NCT00192400|"     The purpose of this study is to determine the efficacy of the liquid formulation of CAIV-T     against culture confirmed influenza illness in healthy children aged at least 6 months and     less than 36 months.   "
179994|NCT00192413|"     To demonstrate that the efficacy over a defined surveillance period against culture-confirmed     influenza-illness caused by community-acquired subtypes antigenically similar to those     contained in the vaccine, in adults aged at least 60 years at enrollment, of a single     intranasally (IN) -administered dose of a liquid formulation of influenza virus     vaccine,(CAIV-T) is non inferior compared with that of a single dose of commercially     available influenza vaccine inactivated (TIV) administered intramuscularly (IM) prior to the     anticipated commencement of the influenza season.   "
179998|NCT00192465|"     To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524     administered initially as a single dose to healthy adults in a dose escalation safety study     before testing in the targeted pediatric population.   "
179999|NCT00192478|"     MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe     and well tolerated.   "
180000|NCT00192491|"     -  To compare immune responses to measles, mumps, rubella, and varicella antigens following          vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in          children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ          (Group 2 vs. Group 1).        -  To compare immune responses to the three strains of influenza (H1N1, H3N2, and B)          following a two dose regimen of FluMist in children who receive the initial FluMist dose          concurrently with MMRIIÒ and VARIVAXÒ and in children who receive two doses of FluMist          alone (Group 2 vs. Group 3).Secondary:        -  To assess the safety and tolerability of concurrent administration of FluMist with          MMRIIÒ and VARIVAXÒ.   "
180001|NCT00192504|"     MEDI-524 administered as a single IV dose at 3, 15, and 30 mg/kg to children hospitalized     with RSV infection was safe and well tolerated.   "
180002|NCT00192517|"     The primary objective of this study is to compare the effects on disease activity, in the     absence of systemic psoriasis therapy, of 4 mg/kg MEDI-522 versus placebo administered weekly     by SC injection for 12 weeks.   "
180003|NCT00192543|"     Cardiovascular disease is the main cause of death in patients on dialysis for end stage renal     disease. Omega-3 fatty acids and antioxidants have been shown to be protective in the general     population. A diet of fish and fruit, which will provide the fatty acids and the antioxidants     is being tried in dialysis patients to assess the effect on cardiovascular disease in this     high risk group.   "
180004|NCT00192556|"     This study will examine whether food is a cost-effective method for improving treatment     compliance for TB patients in Timor Leste. Our hypothesis is that the provision of locally     available, locally acceptable, cheap and highly nutritious food at the clinic will encourage     patients to come for daily directly observed treatment, and thus improve the chance of TB     cure and decrease the chance of the development of TB drug resistance. Primary outcome will     be successful completion of treatment and secondary outcomes will include treatment     compliance and clinical and biological measures of nutritional improvement.   "
180005|NCT00192569|"     Australian Trial in Acute Hepatitis C (ATAHC)      A prospective non-randomised dual arm longitudinal cohort of newly acquired hepatitis C     infection into which participants will be enrolled and then followed at 3 monthly intervals     over a 3 year period.      All participants will be offered a 24 week course of pegylated interferon alfa 2a which will     be commenced within 12 weeks of screening (patients coinfected with HIV will be offered 24     weeks with pegylated interferon alfa 2a plus ribavirin).   "
180006|NCT00192582|"     A new treatment for indigenous people with mental illness in remote communities has been     developed. The study hypothesis is that this new treatment will result in better outcomes for     clients and carers than the outcomes of clients and carers who do not receive the treatment.     The treatment is a combination of a talking treatment and sharing of stories about mental     health. The treatment will be delivered to the client with their chosen carer and with the     local Aboriginal Mental Health Worker or Health Worker. The treatment will be given by the     research team - a psychiatrist and an indigenous research officer. The trial will compare two     groups of clients - a control group which is receiving 'treatment as usual', and the group     which receives the new treatment. Measures of social functioning and symptoms of mental     illness will be administered at base line and every six months for two years.   "
180007|NCT00192595|"     The purpose of the study is to compare the effectiveness of 3 different treatment regimens in     reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B     (co-infection)   "
180008|NCT00192608|"     Saquinavir and Atazanavir are drugs used in combination therapy to treat HIV disease.     Saquinavir is currently available in a 200 milligram capsule. Most individuals currently on     saquinavir require to take 5 tablets twice a day. In an attempt to reduce this number of     pills, a new capsule has been developed containing 500 milligrams of saquinavir. This study     will assess: i) blood drug levels in individuals taking both saquinavir formulations, ii)     blood drug levels in individuals taking both saquinavir formulations when given with     atazanavir, iii) 48 weeks of follow up for individuals receiving the new saquinavir     formulation with atazanavir as HIV therapy.   "
180009|NCT00192621|"     This is a randomised study of the effect of treatment with Combivir (zidovudine [AZT] and     lamivudine [3TC]) and Kaletra (lopinavir [LPVr]), alone and in combination, on the     development of abnormalities in lipid and glucose metabolism in HIV negative healthy     subjects.   "
180010|NCT00192634|"     Combination antiretroviral therapy for the treatment of HIV has a high pill burden. Two     dual-tablets, abacavir-lamivudine and tenofovir-emtricitabine, are now licensed in the United     States and will be available in Australia in December 2005. Data available suggest that the     potency of these tablets are similar in controlling replication of the HIV virus, but not     have not been directly compared in regard to clinically significant toxicities. We therefore     aim to compare the overall safety and efficacy of the two dual-tablets over a 2 year period     in HIV infected adults. We hypothesise that the two dual-NRTI treatments will be similar in     efficacy and safety.   "
180011|NCT00192647|"     This study will evaluate the addition of a higher-dose induction treatment period with     peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with     PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive     participants with CHC, genotype 1 infection.   "
180012|NCT00192660|"     This is a prospective, non-randomised, 48 week study of the effect of protease inhibitor (PI)     containing and non-PI containing antiretroviral regimens on the expression of adipocyte     specific genes, protein levels and cellular structure in HIV-infected individuals, naive to     therapy, who are starting therapy for the first time.   "
180013|NCT00192673|"     The purpose of this study is        1. to determine the correct dose for intramuscular administration        2. to compare the frequency of antibody formation after intramuscular administration of          native E.coli asparaginase and PEG-asparaginase during two treatment courses in the          treatment of childhood lymphoblastic leukemia   "
180014|NCT00192686|"     Cultures from total knee arthroplasties, obtained a.m. Kamme-Lindberg in revision cases.   "
180016|NCT00192712|"     The study hypothesis is that chemoradiation based on 2 drugs will improve local control and     long-term survival in patients with locally advanced pancreatic cancer. That is why     gemcitabine and irinotecan are combined in an induction phase of 2 months and then this     IrinoGem combination is given for 3 more cycles, in reduced doses,concurently with     irradiation.   "
180017|NCT00192725|"     Serotonin (5-HT) is important in mood regulation and is believed to play a major role in the     pathophysiology of major depression (MD). Selective serotonin reuptake inhibitors (SSRIs) are     currently the most widely used drugs for the treatment of depression. Patients with bipolar     disorder (BD) who are treated for depression with SSRIs might develop mania, which is     believed to be triggered by antidepressant treatment. Rapid tryptophan depletion (RTD) has     been shown to induce transient depressive symptoms in remitted depressed patients treated     with SSRIs. In remitted manic patients treated with lithium, RTD does not seem to have     clinical effects. However, RTD was not studied in acutely manic patients and could     theoretically have antimanic properties. In this double blind randomized placebo controlled     study RTD will be used as a tool to assess the role of 5-HT in mania and will be evaluated     for its antimanic properties and potential use as augmentation to drug treatment in acute     mania.   "
187444|NCT00290901|"     This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for     patients with chronic low back pain, when administered over a 6-week period.   "
180018|NCT00192738|"     Several studies have shown the importance of Telephone follow-up in reducing hospital     readmissions for heart failure. Therefore, we aimed in this cohort to investigate whether     telephone follow-up with patients discharged from the general internal department improves     patients' satisfaction, increases compliance to treatment and reduces adverse effects.     Patients are recruited from the department of general internal medicine who gave informed     consent and could communicate. Patients are interviewed by during hospital stay, one and     three months later. This group will be compared with patients that are not interviewd by     phone aftert hospital discharge.   "
180019|NCT00192751|"     The purpose of this study is to determine the benefit and impact on relapse     prevention,adherence to treatment and general health indices of participation in     psycho-eduational group intervention among psychiatric patients with severe mental     illness,recently discharged from inpatient services.   "
180020|NCT00192764|"     The study hypothesis is that intensification of CHOP by dose escalation of the most active     drugs in the combination will improve treatment outcome. Patients with diffuse large-cell     lymphoma are treated by high cyclophosphamide containing CHOP. The planned dose is 3000 mg/m2     which is 4 times the atandard one. Only 4 cycles are given.   "
180021|NCT00192777|"     Hypothesis: Radiosensitization using Xeloda should improve the rate of complete pain relief.      Primary Objective:        -  To determine the frequency of pain relief for the proposed regimen.      Secondary Objective(s):        -  To determine the duration of pain relief and narcotic relief for the proposed regimen.        -  To determine the frequency of narcotic relief for the proposed regimen.        -  To determine the toxicity of concurrent UFT and radiotherapy in patients with bone          metastases.   "
180022|NCT00192790|"     To explore whether reduced systemic pain perception in response to painful stimuli and     personality pain related variables characterizes silent MI patients.   "
180023|NCT00192803|"     This feasibility study is designed to examine modulation of the relative activities of ACE     and ACE2 in diabetic patients following treatment with the angiotensin type 1 receptor (AT1R)     antagonist, Candesartan.      This study will provide a closer insight to the possible involvement of the renin-angiotensin     system (RAS)-related enzymatic components in development or attenuation of vascular     pathogenesis.   "
180024|NCT00192816|"     The purpose of this study is to determine response to pain in Alzheimer's disease.We plan to     study the effect of diffuse noxious inhibitory controls(counterirritation phenomenon)and the     autonomic nervous system reaction(reflected by the heart rate) in Alzheimer's disease. The     study's hypothesis is that pain perception and autonomic nervous system reaction are altered     in Alzheimer's disease.   "
180025|NCT00192829|"     The association between cancer and thrombosis is well known and the occurrence of thrombotic     complications is commonly associated with poor prognosis. The aim os this study is to     determine the possible value of hypercoagulable parameters as prognostic parameters in     advanced non-small cell lung carcinoma (NSCLC).   "
180026|NCT00192842|"     The study hypotheasis is that curcumin, a natural compound with a potent antiproliferative     effect, can improve the efficacy of the standard chemotherapy gemcitabine in patients with     advanced pancreatic cancer. That is why the patients are given a daily oral dose of 8 gr of     curcumin along the chemotherapeutic protocol of weekly gemcitabine.   "
180027|NCT00192855|"     This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment     can be beneficial in schizophrenic patients with negative symptoms.   "
180028|NCT00192868|"     The purpose of this study is to evaluate the clinical, echocardiographic and angiographic     outcome of distal protection in the infarct related coronary artery and implantation of drug     eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated     acutely with percutaneous coronary intervention.   "
180029|NCT00192881|"     The purpose of this study is to evaluate the clinical and angiographic outcome of     implantation of stents eluting or not eluting Sirolimus in patients with complex coronary     artery lesions suitable for percutaneous coronary intervention.   "
180030|NCT00192894|"     The purpose of this study was to evaluate the changes in heart function during onset of     spinal anesthesia using a new and less invasive method, the LidcoTMplus.   "
180031|NCT00192907|"     The purpose of this study is to investigate the relationship between trauma, the immune     system, biochemical changes in the first 24 h and subsequent complications and mortality   "
180032|NCT00192920|"     The purpose is to evaluate and improve transfusion practice   "
180033|NCT00192933|"     The purpose is to evaluate and improve NovoSeven treatment practice done according to our     guidelines   "
180034|NCT00192946|"     In patients with broad QRS complexes on electrocardiogram (ECG), the delayed electrical     activation of the left heart chamber will cause abnormal contraction.This has been shown to     be possible to treat by a special pacemaker treatment which includes pacing of the left heart     chamber (= CRT treatment).      In this study the researchers will investigate the effect of acute CRT treatment in the early     phase after open heart surgery.   "
180035|NCT00192959|"     The primary objective was to explore the feasibility of inhaled xenon for sedation in terms     of its effect on postoperative cognitive function in elderly, in comparison with the     postoperative cognitive function found after IV propofol sedation in the same population.The     secondary objectives were designed to assess the feasibility of xenon sedation in terms of     its effects on different neuropsycho-logical test variables, vital signs, sedation levels and     safety in elderly orthopaedic subjects.   "
180036|NCT00192972|"     Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have     been proven effective in the treatment of atrial fibrillation.      In this study patients with symptomatic paroxystic or persistent AF were randomised to one of     the above mentioned ablation methods. The primary endpoints were recurrent AF and recurrence     of left atrium-PV conduction.   "
180037|NCT00192985|"     Urinary tract infections occurs in trauma. We investigate whether a nitrofurazone coated can     reduce the number of urinary tract infections.   "
180038|NCT00192998|"     The aim of this project is to examine the serotonergic transmitter system using functional     imaging of the brain (positron emission tomography [PET]) to gain knowledge about early     pathophysiological changes in Alzheimer's dementia and mood disorders.   "
187445|NCT00290914|"     The purpose is to evaluate the safety and usefulness of the investigational drug, vilazodone     in depression.   "
180039|NCT00193011|"     This trial will evaluate the effectiveness of standard adjuvant treatment with CMF     chemotherapy versus treatment with weekly docetaxel in patients with high-risk breast cancer     who are 65 years of age and older or are poor candidates for anthracycline-containing     regimens. This CMF regimen has decreased dose intensity and may be slightly less active in     patients with metastatic breast cancer; however, the patient population in this trial has     tolerated more intensive CMF regimens poorly in other trials.   "
180040|NCT00193024|"     The epirubicin/docetaxel combination is one of the most active and best tolerated     taxane/anthracycline combinations. In this phase II trial, we will further evaluate the     feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when     administered as first-line treatment for metastatic breast cancer.   "
180041|NCT00193037|"     The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will     be evaluated as first line treatment in metastatic breast cancer patients, with subsequent     crossover to the opposite arm at disease progression or patient intolerance. We will explore     this as well as any possible cross resistance between these two agents.   "
180042|NCT00193050|"     Treatment strategies that include induction chemotherapy have several potential advantages:     early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging     of both the primary tumor and regional lymphatic metastases, making breast conservation an     option for many. The aim of the present study is to determine the efficacy and toxicity of     induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel,     in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the     upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new     agents and combination of agents are likely to have the greatest potential impact.   "
180043|NCT00193063|"     Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as     well as the additive activity observed for gemcitabine administered in combination with     trastuzumab, the clinical activity of the combination of gemcitabine administered with     trastuzumab represents an exciting and ideal combination to further evaluate in Her 2     over-expressing metastatic breast cancer patients.   "
180044|NCT00193076|"     Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is     synergistic, and both drugs may be synergistic with trastuzumab. Additionally, recent     clinical data suggest that the combination of gemcitabine with platinum is an active regimen     in metastatic breast cancer. This study will test the combination of gemcitabine with     carboplatin in patients with metastatic breast cancer. Patients with Her2/neu overexpression     will be stratified to receive trastuzumab in addition to gemcitabine and carboplatin.   "
180045|NCT00193089|"     In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine     combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is     well tolerated with minimal myelosuppression, so that it is likely that fully efficacious     doses of all three drugs can be administered   "
180046|NCT00193102|"     The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug     administration, and the possibility for antitumor synergy make exploration of this     combination regimen attractive in women with previously treated metastatic breast cancer.     This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research     Network, a multicenter, community-based clinical trials group.   "
180047|NCT00193115|"     This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by     doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of     women with node positive and high risk breast cancer   "
180048|NCT00193128|"     In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used     concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of     the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we     will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs     (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the     3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the     3-drug combination is considered too toxic, the phase II study will proceed with     docetaxel/oxaliplatin in combination with radiation therapy.   "
180049|NCT00193141|"     In this randomized study, we plan to address the important question of optimum local     treatment for patients with localized esophageal cancer. All patients will receive our     previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-FU,     and radiation therapy to 45 Gy. At the completion of neo-adjuvant therapy, patients will be     randomized to undergo surgical resection, or to continue radiation to a total dose of 60 Gy,     along with one additional course of chemotherapy.   "
180050|NCT00193154|"     In this phase II trial, we plan to evaluate the combination of Tarceva and Avastin in the     treatment of patients with metastatic renal cell carcinoma. This trial will be one of the     first phase II trials to evaluate a combination of targeted agents in the treatment of a     common solid tumor with a strong biologic rationale based on Cancer Biology     (VHL/HIF/VEGF/EGFr).   "
180053|NCT00193193|"     In this trial we will investigate how this three-drug regimen may be improved, both with     respect to efficacy and toxicity, by making some modifications in the dosing and schedule in     the treatment of patients with hormone refractory prostate cancer.   "
180054|NCT00193206|"     In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the     biweekly pegfilgrastim support, in order to further improve upon the effectiveness and     favorable toxicity of this triplet.   "
180055|NCT00193219|"     This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin,     oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal     cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of     advanced colorectal cancer. The role of epidermal growth factor (EGFR) inhibitors in an     earlier treatment setting in combination with optimal chemotherapy regimens is an important     emerging question.   "
180056|NCT00193232|"     Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for     patients with advanced hormone-refractory prostate cancer.   "
180057|NCT00193245|"     In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with     intravenous docetaxel in the second-line treatment of patients with non-small cell lung     cancer.   "
180058|NCT00193258|"     This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition     of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects.     Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been     demonstrated, the mild to moderate side effects of all of these agents are not predicted to     cause prohibitive toxicity. A brief phase I portion will be included in this trial, to     optimize doses of the 3 agents prior to proceeding with the phase II trial.   "
180059|NCT00193271|"     This trial will evaluate the feasibility, toxicity, and efficacy of docetaxel/estramustine,     as in the adjuvant therapy of patients with high-risk prostate cancer after definitive local     therapy.   "
180060|NCT00193284|"     Although gefitinib has been combined successfully with various chemotherapeutic regimens with     minimal increase in overall toxicity, experience with concurrent radiation therapy is     limited. In this trial, we will evaluate the feasibility, toxicity, and effectiveness a novel     combination of chemotherapy, radiation therapy, and gefitinib.   "
180061|NCT00193297|"     The purpose of this study is to evaluate the feasibility and toxicity of the combination of     paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV     epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary     evaluation of the efficacy of this three drug regimen in the initial treatment of these     patients.   "
180062|NCT00193310|"     In this phase II study, we plan to evaluate several novel components of therapy. In patients     with potentially resectable stages IIB (T3N0) and IIIA we will compare weekly paclitaxel and     carboplatin with concomitant radiation therapy versus weekly paclitaxel and every 4 week     carboplatin in the preoperative (neoadjuvant) setting. For patients with potentially     resectable stage IB, IIA and IIB (T2N1) tumors, weekly paclitaxel and every 4 week     carboplatin will be given pre-operatively (neoadjuvant). The feasibility of resection will be     evaluated in the neoadjuvant group of patients. The continued study of concurrent radiation     therapy with weekly paclitaxel and carboplatin will be evaluated in those patients with stage     IIB (T3N0) and IIIA disease who initially had resection (adjuvant setting). Lastly, weekly     paclitaxel and carboplatin every 4 weeks will be evaluated as an adjuvant program in patients     who had completely resected stage IB, IIA and IIB (T2N1).   "
180063|NCT00193323|"     In this randomized trial, we attempt to further define optimal palliative chemotherapy for     elderly patients with advanced non-small cell lung cancer by comparing single agent treatment     with weekly docetaxel versus combination therapy with weekly docetaxel plus gemcitabine.   "
180064|NCT00193336|"     Because of the demonstrated single agent activity and excellent tolerability in patients with     refractory non-small cell lung cancer, ZD1839 may be of benefit in the first-line treatment     of patients with advanced non-small cell lung cancer who have poor performance status. In     this phase II trial, we will investigate the single agent activity of first-line ZD1839 in     patients with advanced non-small cell lung cancer with poor performance status   "
180065|NCT00193349|"     This study will evaluate combination chemotherapy for patients with extensive stage small     cell lung cancer combined with the potentially useful growth inhibiting effects of Gleevec.   "
180066|NCT00193362|"     The purpose of this study is to compare the effectiveness of the three-drug combination     paclitaxel, carboplatin, and gemcitabine to the two-drug combination gemcitabine and     vinorelbine in patients with advanced Non-Small Cell Lung Cancer   "
180067|NCT00193375|"     In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial     treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with     bevacizumab, in patients with limited stage small cell lung cancer.   "
180068|NCT00193388|"     In this phase II trial, we will evaluate the weekly schedule of topotecan in the second-line     treatment of patients with small cell lung cancer   "
180069|NCT00193401|"     In this phase II trial, we will evaluate the weekly schedule of topotecan in the first-line     treatment of elderly and/or poor performance status patients with extensive stage small cell     lung cancer. Patients eligible for this trial will be those considered poor candidates for     standard combination chemotherapy or other investigational regimens   "
180070|NCT00193414|"     This study is designed to study the role of an active and well-tolerated non-platinum agent,     gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced     NSCLC. This study will serve to define the role of next generation agents in a new     combination regimen in the treatment of advanced NSCLC. This combination regimen may     ultimately be important in further expanding treatment options for patients while improving     survival, quality of life, and symptom control compared with platinum-based combination     regimens - and with acceptable toxicity.   "
180071|NCT00193427|"     This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively     non-toxic combination in advanced NSCLC. This study will help to better define optimal     preoperative regimens for patients with resectable NSCLC. Since both of these drugs are     potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may     produce not only radio-sensitization, but also considerable antitumor efficacy.   "
180072|NCT00193440|"     In this trial, we will evaluate the feasibility, toxicity, and effectiveness ibritumomab     tiuxetan, when incorporated into combination first-line treatment for follicular lymphoma.     Addition of the ibritumomab tiuxetan to our previously evaluated, well tolerated combination     of rituximab and short course chemotherapy will allow the use of additional active agent with     a unique mechanism of cytotoxicity. In addition, debulking of lymphoma prior to 90Y Zevalin     administration may minimize the myelotoxicity of this agent.   "
180073|NCT00193453|"     This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well     tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer     (NSCLC), in combination with a novel agent cetuximab.   "
180074|NCT00193466|"     In this multicenter trial, we will investigate the use of fludarabine plus rituximab,     followed by Campath-1H, in previously untreated patients with CLL/SLL. Patients who are     elderly, or who are considered unlikely to tolerate this combination therapy well, will     receive single agent rituximab followed by Campath-1H.   "
180127|NCT00194155|"     The purpose of this study is to determine if (recurrent) cytomegalovirus (CMV) infection of     the mother results in pregnancy complications such as preterm delivery, severe preeclampsia,     poor fetal growth, or stillbirth.   "
180075|NCT00193479|"     The purposes of this trial are to decrease toxicity and improve treatment effectiveness     elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone,     vincristine, and prednisone with concurrent administration of rituximab it is likely to be as     effective as longer programs, and will certainly be better tolerated by this patient group.     The addition of maintenance therapy may result in substantial prolongation of remission     duration.   "
180076|NCT00193492|"     The purpose of this study is to assess the feasibility, efficacy and safety of adding     bevacizumab to rituximab compared to rituximab alone in patients with previously treated     follicular non-hodgkin's lymphoma (NHL) whose disease has progressed following at least one     previous chemotherapy regimen and not more than 2 previous chemotherapy regimens.   "
180077|NCT00193505|"     In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of     treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with     relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.   "
180078|NCT00193518|"     Additional active agents are needed to further improve the treatment of patients with     CLL/SLL. Increasing information exists regarding the activity of arsenic trioxide in other     hematologic malignancies. Since arsenic trioxide produces mild to moderate myelosuppression     and is not as immunosuppressive as other available agents, it may be an additional treatment     option for CLL/SLL. This study will evaluate the feasibility and toxicity of arsenic trioxide     in patients with relapsed or refractory CLL/SLL   "
180079|NCT00193531|"     carboplatin and etoposide, followed by maintenance therapy with weekly paclitaxel in patients     with poorly differentiated neuroendocrine carcinomas. We hope to identify a standard     treatment for this unusual group of patients who are not usually eligible for clinical     trials.   "
180080|NCT00193544|"     In this trial, we plan to evaluate further the role of arsenic trioxide in the treatment of     patients with refractory multiple myeloma. Arsenic trioxide will be used in combination with     thalidomide. Although both drugs have a similar mechanism of action, it is likely that the     mechanisms may be additive or synergistic. Since neither drug produces much myelosuppression,     this combination regimen should be tolerable in patients with compromised marrow function due     to involvement with myeloma and/or previous cytotoxic chemotherapy   "
180081|NCT00193557|"     This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the     treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly     schedule of bortezomib is effective in producing responses in patients with stable disease or     progression after weekly bortezomib   "
180082|NCT00193570|"     This phase I study will characterize the safety, tolerability, and maximum tolerated dose and     dose-limiting toxicity of weekly bolus Topotecan when administered in combination with to     different dosing regimens of docetaxel. We will also evaluate any anti-tumor activity of the     combination regimen.   "
180083|NCT00193583|"     In this phase I study we will characterize the safety, tolerability, maximum tolerated dose     and dose-limiting toxicity of weekly bolus topotecan when administered in combination with     two different dosing schedules of carboplatin. We will also evaluate any antitumor activity     of these combination regimens.   "
180084|NCT00193596|"     In this randomized trial, we will investigate the activity and toxicity of two active     regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by     ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.   "
180085|NCT00193609|"     In this phase II trial, we will evaluate the feasibility and efficacy of the     oxaliplatin/capecitabine combination in patients who have had one previous chemotherapy     regimen for the treatment of carcinoma of unknown primary site. Patients who are relapsed     after a previous response to treatment will be eligible, as well as those who were refractory     to first-line therapy.   "
180086|NCT00193622|"     This trial will investigate the combination of bevacizumab, and erlotinib in patients with     adenocarcinoma or poorly differentiated carcinoma of unknown primary site. Bevacizumab and     erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. This     trial will be one of the first clinical trials to evaluate a combination of targeted agents     in the treatment of a solid tumor.   "
180097|NCT00193765|"     Cervical nodal metastasis is the single most important prognostic factor in head and neck     cancers. Appropriate management of the neck is therefore of paramount importance in the     treatment of these cancers. While it is obvious that the positive neck must be treated,     controversy has always surrounded the clinically node negative neck with respect to the ideal     treatment policy.The situation is difficult with regards to early cancers of the oral cavity     (T1/T2). These cancers are usually treated with surgery where excision is through the     per-oral route. Elective neck dissection in such a situation is an additional surgical     procedure with its associated costs, prolonged hospitalization and may be unnecessary in as     high as 80% of patients who finally turn out to be pathologically node negative. Should the     neck be electively treated or there be a wait and watch policy? Current practice is that the     neck is always addressed whenever there is an increased propensity to cervical metastasis or     when patient follow-up is unreliable.      There is clearly a need therefore for a large randomized trial that will resolve the issue     either way once and for all.      Primary Objective:      To demonstrate whether elective neck dissection (END) is equal or superior to the wait and     watch policy i.e.      therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2     cancers of the oral cavity.      Secondary Objective:        1. Does Ultrasound examination have any role in the routine initial workup of a node          negative patient?        2. How are patients ideally followed up -does sonography have a role or is clinical          examination sufficient.        3. Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate          -Is there a correlation        4. Identify histological prognostic factors in the primary that may help identify a sub-set          of patients at an increased risk for cervical metastasis.   "
180098|NCT00193778|"     Traditionally metastatic breast cancer patients are not offered loco-regional treatment     except in cases of fungation or bleeding. However, scientific evidence for such omission of     loco-regional treatment in metastatic breast cancer patients is lacking. On one hand, studies     have shown that removal of primary tumor at times leads to complete disappearance of     metastases and improvement in survival in renal cell carcinoma patients. However, such     studies have never been performed in other solid tumors. On the other hand, there is a strong     body of evidence in experimental settings that show that removal of primary tumor allows     growth of metastasis. There is lack of similar data in humans in clinical settings. Offering     loco-regional treatment in metastatic breast cancer patients in a setting of randomized     controlled trial will help in improving survival of such patients and understanding the     natural history of breast cancer.   "
180231|NCT00203177|"     Study to look at the effectiveness, tolerability and safety of two doses of Rasagiline (0.5     mg and 1mg) in advanced Parkinson's Disease (PD) Patients who have been treated with     Levodopa/Carbidopa therapy.   "
180087|NCT00193635|"     Congenital or hereditary structural anomalies of the genitourinary tract account for     approximately half of all cases of end stage renal disease in the pediatric population.     Despite optimal medical management, when the GFR falls below 50 ml/min/1.73 M2, nearly 40% of     affected children will require dialysis or a renal transplant within 2 years. At present,     there is no specific treatment for patients with congenital uropathies that can retard the     progressive loss of kidney function and forestall the need for renal replacement therapy.      There is evidence in experimental animals and in patients with chronic renal failure (CRF)     that immunoeffector mechanisms are activated within the renal parenchyma. Infiltration of the     kidney by macrophages, monocytes, and lymphocytes, activation of renal tubular epithelial     cells, and release of pro-inflammatory cytokines result in fibrosis and irreversible organ     damage.      Mycophenolate mofetil (MMF) is a new immunosuppressive agent that is used to prevent acute     rejection in kidney transplant recipients. It attenuates renal damage in the remnant kidney     model of CRF in which there is no primary immunological injury. Therefore, this pilot study     is designed to test the hypothesis that immunosuppressive treatment with MMF in children with     structural causes of CRF will be safely tolerated and that this therapy will retard     progressive decline in renal function.      Patients with congenital uropathy, 3-16 years of age and with a GFR less than 50 ml/ml/1.73     M2, will be treated with MMF for 24 months. The two primary endpoints are: (1) safety and     tolerance of the drug; and (2) need for dialysis or kidney transplantation. It is anticipated     that the MMF will be free of significant toxicity and that administration of the drug will     reduce the frequency of progression to end stage renal disease from 38% to 19%. Patients will     be followed at 3-month intervals and they will undergo serial assessment of proteinuria,     estimated GFR and iothalamate clearance, urinary cytokine excretion, urine flow cytometry,     and immunologic testing.      The significance of this pilot study is that it may provide evidence in support of a     randomized, double-blind, placebo-controlled trial of immunological treatment of congenital     structural causes of CRF in children   "
180088|NCT00193648|"     The current management of primary FSGS is predicated on the assumption that the disease is     caused by an immune-mediated disturbance in glomerular barrier function. Therefore, most     treatment protocols have involved immunosuppressive drugs given singly or in combination.     However, the efficacy of this type of therapy has been disappointing and the long-term     prognosis for renal survival in patients with resistant FSGS is poor. An alternative approach     that targets the fibrosis pathway may represent a novel approach to the treatment of     resistant FSGS. In this R21, the investigators will test the hypothesis that two novel agents     - a tumor necrosis factor-alpha (TNF-α) antagonist and a peroxisome proliferator activator     receptor-gamma (PPARγ) agonist - can be administered safely to patients with resistant FSGS.     In the R21 feasibility/pilot phase, pharmacokinetic studies will be conducted to assess the     impact of proteinuria on the kinetics of the novel drugs in children and adults.      Specific Aim #1: To assess the safety and tolerability of two novel drugs - a TNF-α     antagonist and a PPARγ agonist - in patients with resistant FSGS.      Specific Aim #2: To conduct a pharmacokinetic (PK) assessment of the selected agents to     enable selection of medication regimens for investigation in a randomized Phase II study.   "
180089|NCT00193661|"     This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty     adolescents. Subjects who complete this trial may enter a 3 month extension study     (UMD-01-090E).   "
180090|NCT00193674|"     The purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to     non-inflammatory cytokines in women suffering from habitual abortion treated with     dydrogesterone (Duphaston).   "
180091|NCT00193687|"     Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.     Extension to study S154.3.001.   "
180092|NCT00193700|"     Measure and evaluate the level of testosterone in blood, and determine the safety and     tolerability following daily applications of testosterone gel. Subjects who complete this     trial may participate in the extension part (UMD-01-080E).   "
180093|NCT00193713|"     Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.   "
180094|NCT00193726|"     One of the basic principles of cancer chemotherapy is that these drugs act exclusively or     mainly on cells in cycle. Estrogens have been shown to increase the fraction of breast cancer     cells in cycle. Tamoxifen on the other hand, decreases the proliferative fraction and has     been shown to negatively impact on the results of adjuvant chemotherapy in breast cancer when     given concomitantly. A number of previous studies have attempted estrogenic recruitment of     cancer cells (into cell cycle) to increase the efficacy of chemotherapy in locally advanced     and metastatic breast cancer. Although some studies showed an increase in response rates in     the recruitment arm, there was no benefit in time to progression or survival in any of the     studies. These results may have been due to the inadequate sample size of the studies and     advanced stage disease (with presumably higher fraction of inherently chemoresistant cells).     The present study is designed to test the hypothesis that estrogenic recruitment of     micrometastatic disease in operable breast cancer will increase the efficacy of standard     adjuvant chemotherapy after surgery. The intervention arm of the study will involve     administration of short duration estrogen prior to each cycle of adjuvant chemotherapy. The     end-points are disease free and overall survival.   "
180095|NCT00193739|"     Carcinoma cervix is a common malignancy in women in developing countries including India. The     standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant     chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a     meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant     chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these     patients. However NACT-Surgery approach has never been compared to the current standard of     concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3     courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to     IIB squamous cell carcinoma of the uterine cervix.   "
180096|NCT00193752|"     18F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging has been extensively     used in the evaluation of various malignancies and is rapidly being recognized as a mandatory     investigations. 18F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging has     also been tried in cervical cancers with excellent results for detection of both pelvic and     extra-pelvic disease in terms of sensitivity and specificity. Till date, PET Imaging has been     reported to have highest sensitivity and specificity for detection of disease and treatment     failures compared to other non-invasive investigations available. Treatment decisions     (Localized RT Vs Extended RT) will be according to the results of PET Scans. The treatment     response, outcome and follow-up will be labelled according to the PET Scan results and will     be directed for treatment accordingly.   "
180108|NCT00193908|"     This study has patients using two different moisturising creams during radiation therapy     after mastectomy. These are Cavilon and sorbolene. It is hypothesised that skin reactions may     be reduced by the Cavilon cream compared to sorbolene.   "
180099|NCT00193791|"     A study to evaluate the efficacy of concomitant chemoradiation as compared to radiotherapy     alone. Concomitant chemoradiation is not a new treatment modality for carcinoma cervix.     Studies have shown improvement in survivals with chemoradiation, but majority of the patients     was in early stages. Since this treatment modality has not been tested adequately in advanced     stages in our setting, the present study is being undertaken. The study arm of chemoradiation     has the potential to improve the survivals by 10%, but is associated with additional 5% risk     of toxicities, which are treatable. In the study arm, apart form the standard radiotherapy     treatment, you will receive weekly chemotherapy injections (Cisplatin) during external     radiation therapy. The study arm is associated with additional 5% acute hematological and     gastrointestinal toxicities, which are treatable with medications, blood transfusions,     modifications in the ongoing treatment etc.   "
180100|NCT00193804|"     A study to evaluate the efficacy of Intensity Modulated Radiation Therapy (IMRT) as compared     to Standard Conventional Radiotherapy Alone in the treatment of carcinoma cervix. Concomitant     Weekly Cisplatin chemotherapy will be given as a routine, which is a standard of care today     for early stage cervical cancers including stage IIB. The benefits of using IMRT in reducing     radiation-induced toxicity are well known. Since this treatment modality has not yet been     validated and studied in a randomized trial setting, the present study is being undertaken.     The study arm of IMRT has the potential to reduce the toxicities by 15-20%, but is associated     with labor intense procedure requiring many hospital visits before actual start of treatment.   "
180101|NCT00193817|"     Surgery is the standard treatment for esophageal (food pipe) cancer. Esophageal cancer is     known to spread to the lymph nodes (glands) adjacent to the esophagus. The extent of lymph     nodes that need to be removed along with removal of the esophagus is a controversial topic.     The basic surgery will remain the same i.e., the foodpipe in the chest will be removed and a     new substitute will be created from the stomach and joined to the foodpipe in the neck. This     will involve incisions in the chest, abdomen and neck. We intend to compare two types of     lymphadenectomy (removal of lymph nodes) - the two field lymphadenectomy, whereby the lymph     nodes in the abdomen and the lower half of the chest will be removed and three field     lymphadenectomy, wherein lymph nodes in the abdomen, the whole chest and the lower neck will     be removed. Both these procedures are practised widely worldwide and there is no definite     scientific evidence showing the superiority of either of them. We are conducting this study     to see whether one of these procedures is superior to the other. Seven hundred patients are     expected to participate in this study.   "
180102|NCT00193830|"     Radiation therapy still remains mainstay of treatment for patients with carcinoma cervix in     advanced stages. Conventional treatment with radiation therapy includes a combination of     external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary     brachytherapy treatment is the time-tested modality of brachytherapy with sound     radiobiological bases. But high dose rate brachytherapy is a relatively new alternative. In     low dose rate brachytherapy the staff receives some radiation while in the high dose rate     brachytherapy procedure complete protection to staff can be achieved as the treatment is done     with remote afterloading technique. The high dose rate brachytherapy is possible as Out     Patient Department procedure. Few clinical trials have proven the feasibility and efficacy of     high dose rate brachytherapy in carcinoma of cervix. However, there is no concrete evidence     especially in developing countries for the change of practice to HDR brachytherapy. Hence, at     Tata Memorial Hospital with an aim to assess the efficacy, feasibility, early and late     complications of high dose rate brachytherapy in contrast with low dose rate brachytherapy we     propose this study.   "
180103|NCT00193843|"     To demonstrate whether addition of Concurrent chemotherapy to post-operative adjuvant     radiotherapy OR shortening of duration of post-operative radiotherapy, by administering 6     fractions / week instead of 5 fractions / week improves local-regional control and / or     overall survival in high risk, locally advanced, resectable, squamous cell carcinoma of oral     cavity.   "
180104|NCT00193856|"     The principal objectives of the RADAR trial is to address the hypotheses; 1) that 18 months     androgen deprivation in conjunction with radiotherapy is superior to 6 months androgen     deprivation prior to and during radiotherapy; 2) that 18 months Bisphosphonate therapy will     prevent bone loss caused by androgen deprivation therapy and further reduce relapse risk by     impeding the development of bony metastases.   "
180105|NCT00193869|"     The study aimed to pilot the viability of a full scale randomised comparison of 2 steroid     doses in malignant spinal cord compression, to establish safety of high dose dexamethasone in     this setting in Australia, to test web registration and randomisation and to compare     different functional outcome measures.   "
180106|NCT00193882|"     To compare the treatment of gullet cancer with radiotherapy alone and assess the advantage     and toxicity of adding chemotherapy. The hypothesis to be tested is as follows: That the     addition of chemotherapy to a short course of radiation treatment improves the proportion of     patients who achieve relief of dysphagia and improves quality of life compared to radiation     alone in patients with advanced oesophageal cancer.   "
180107|NCT00193895|"     The primary objective of the trial is to determine, in patients who have undergone surgery     with curative intent for high-risk CSCC of the head and neck, whether there is a difference     in time to loco-regional relapse between patients treated with post-operative concurrent     chemo-radiotherapy ,consisting of Carboplatin, and post-operative radiotherapy alone. The     target sample size for the trial is 266 patients and will take 3-4 years to accrue, based on     an anticipated accrual of 80 patients/year. A further 2 years follow up is required.   "
180109|NCT00193921|"     The study compares 2 different methods of combined chemotherapy and radiotherapy for the     treatment of localised lung cancer in patients not suitable for surgery.      Hypothesis(es) to be tested:        1. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine +          high dose palliative radiotherapy in terms of efficacy in a multi-institutional setting        2. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine +          high dose palliative radiotherapy in terms of feasibility in a multi-institutional          setting        3. Vinorelbine + cisplatin + high-dose palliative radiotherapy has a favourable toxicity          profile relative to gemcitabine + high-dose palliative radiotherapy   "
180125|NCT00194129|"     This study will determine the efficacy and safety of combination therapy with divalproex and     lithium for treating mania in people with rapid cycling bipolar disorder and a substance     abuse disorder.   "
180110|NCT00193934|"     The researchers propose that it may be corpus invasion, rather than tumour volume per se,     which is one of the important determinants of ultimate outcome in cervix cancer. The aim of     the proposed prospective, multicentre study, is to confirm the results of our retrospective     studies, specifically that corpus invasion or tumour volume or both contribute important     prognostic information over and above that provided by the currently used International     Federation of Gynecology and Obstetrics (FIGO) staging system. A successful outcome would     have important implications for the staging, and management as well as the biologic     understanding of the behaviour of cervical cancer.   "
180111|NCT00193947|"     Hypothesis      Nevirapine resistance developed in women and infants in the HIVNET 006 and 012 cohorts as a     consequence of use of an agent with a long t½ as monotherapy in individuals with high viral     loads.      Objective 1 To demonstrate that Nevirapine resistance does not develop in HIV infected     patients when used as part of triple antiretroviral combination therapy between the     initiation of treatment and suppression of HIV RNA to <1000 copies/ml.      Objective 2 To demonstrate that resistance to nevirapine does not develop when patients with     suppressed HIV RNA discontinue combination antiretroviral therapy which contains nevirapine.   "
180112|NCT00193960|"     Glaucoma drainage devices are usually placed in the superior quadrants. The superotemporal     quadrant is usually the site of choice. However, when the upper fornix is scarred and     especially when conjunctiva is two fibrotic to enable adequate coverage of tube with a     scleral or other patch graft, some surgeons place the tube in one of inferior quadrants.   "
180113|NCT00193973|"     Idarubicin combined with high dose methotrexate and moderate dose radiotherapy will achieve     similar survival outcomes but with reduced neurotoxicity compared to regimens using     methotrexate with high dose radiotherapy.   "
180114|NCT00193986|"     Patient tolerance of pain from discharges of implantable cardioverter defibrillators (ICD's)     is highly variable. It can be influenced by psychological factors, physical condition and the     number of shocks delivered.      It has been shown that cutaneous pain perception can be reduced by delivery of a weak , low     voltage pulse (prepulse)prior to the delivery of a stronger shock.      A prepulse delivered before a high voltage ICD shock will decrease discomfort compared to a     shock of equal energy without a prepulse.   "
180115|NCT00193999|"     Gastric emptying is delayed after cardiac surgery, but the efficacy of the nasogastric (NG)     tube in preventing distension and reducing vomiting is unclear. Nasogastric (NG) tubes are     routinely used in patients undergoing surgery. They are presumed to reduce postoperative     nausea and vomiting (PONV) and to lessen the risk of aspiration by reducing residual gastric     volumes; however, their insertion and use is not however without potentially serious     complications. Existing literature does not address their efficacy in reducing PONV after     cardiac surgery. However, current evidence suggests that up to 50% of patients in this group     suffer significant nausea and vomiting. The objective of this study is to determine whether     NG tubes should continue to be inserted routinely during cardiac surgery to reduce PONV.   "
180116|NCT00194012|"     The purpose of this study is to test the effectiveness and tolerability/safety of     aripiprazole (Abilify) in children with subsyndromal symptoms of bipolar disorder who also     have a parent with bipolar disorder and other family member with a mood disorder.   "
180117|NCT00194025|"     The purpose of this research study is to analyze the effectiveness and tolerability of a     medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who     have schizophrenia.   "
180118|NCT00194038|"     The purpose of this research study is to analyze the effectiveness and tolerability of a new     medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar     disorder (manic-depressive illness).   "
180119|NCT00194051|"     Weight is a risk factor for knee osteoarthritis      Knee osteoarthritis is associated with abnormal gait biomechanics      Gait biomechanics are evaluated in gastric bypass patients before and after losing 100     pounds.   "
180120|NCT00194064|"     Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in     Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with     Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing     to spend initial 7 days in the hospital to observe response to medication. Patients must be     refractory (intolerant or non-responsive) to treatment with lithium and valproate or     carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli     Lilly and Company.   "
180121|NCT00194077|"     The purpose of this study is to look at the safety and effectiveness of aripiprazole     (abilify) in children with bipolar disorder and to examine whether or not patients that     respond to initial mood stabilization benefit from continued pharmacotherapy.   "
180122|NCT00194090|"     A paced 20-minute walk is a reproducible model for acute pain in knee osteoarthritis   "
180123|NCT00194103|"     The purpose of this study is to determine the effectiveness of extended telephone monitoring     for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized     that telephone monitoring will produce better alcohol use outcomes relative to treatment as     usual. It is also hypothesized that adaptive telephone monitoring plus brief counseling will     produce better alcohol use outcomes over time relative to telephone monitoring plus feedback     only.   "
180140|NCT00201565|"     Arterial pulse wave velocity (PWV) is strongly correlated with atherosclerosis, and the PWV     of carotid or femoral artery could predict the severity of arterial atherosclerosis. Because     the measurement of PWV is noninvasive, it would serve as a good clinical and screen marker to     evaluate the extent of atherosclerosis. The study uses self-made PWV measurement device to     investigate the correlation of the PWV in the high cardiovascular risk population, and     compare it with normal population.   "
180124|NCT00194116|"     Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression     Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and     females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II     disorder and are currently experiencing an episode of major depression. Patients are     randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the     study for up to six weeks. This six-week double-blind treatment period is followed by an     open-label treatment period of six months duration. This study is sponsored by Abbott     Laboratories.   "
180128|NCT00194168|"     In an attempt to simplify the diagnosis of ectopic pregnancy, the researchers will     investigate the presence of specific molecular markers of ectopic pregnancy. The     quantification of these (and other proteins) will be performed using the Ciphergen Protein     Chip system where serum is sampled with a high-throughput system. The patterns of these peaks     will be compared for those with a diagnosis of ectopic pregnancy and normal pregnancy. Later     goals of the research will be to identify the actual proteins that correspond to the peaks     which discriminate between the two clinical entitles. The goal is to identify a unique     protein pattern or protein peak to distinguish a normal intrauterine pregnancy from that of     an ectopic implanted gestation.   "
180129|NCT00194181|"     Treating central venous dialysis catheter malfunction due to fibrin sheath formation with     rt-PA(TPA)infusion will give equal patency rates in a more cost effective manner when     compared to catheter exchange.      Subjects are randomized to TPA infusion or catheter exchange and then followed for catheter     function at the post treatment dialysis session, 30-day dialysis session and 60-day dialysis     session. Costs and treatment results will be compared.   "
180130|NCT00201435|"     We want to compare Taxol given weekly with Taxotere given every 3 week both in comination     with Xeloda. We are going to compare time to treatment failure and quality of life.   "
180131|NCT00201448|"     The purpose of this study is to evaluate the safety and effectiveness of a vaccine given to     women ages 18-45 to prevent cytomegalovirus (CMV), which they may catch from their children     who attend daycare centers. Cytomegalovirus does not usually cause serious illness in adults     and children. However, CMV can be a cause of deafness and mental retardation in a child born     from a mother who has the infection during pregnancy. Women in the study will be given either     cytomegalovirus or Hepatitis A vaccine. A blood sample will be taken before the vaccination     is given. After vaccination, urine, saliva, and blood will be collected every 1-6 months for     up to 3 years. Information regarding any reaction to the vaccination will be collected. All     family members will be asked to provide urine and saliva to test for CMV every few months for     up to 3 years. All children born to women who have been vaccinated will be tested for CMV     infection. 180 women who are not infected with CMV will be vaccinated.   "
180132|NCT00201461|"     The primary objective of the study is to determine whether the STARFlex® septal closure     system will safely and effectively prevent a recurrent embolic stroke/transient ischemic     attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the     STARFlex® device compared to best medical therapy.   "
180133|NCT00201474|"     The purpose of the study is to investigate whether patients with brief depressive periods     together with other fluctuating psychiatric symptoms, have this condition due to epilepsy or     an other organic brain disorder.   "
180134|NCT00201487|"     Choline has been found in increased concentration in breast cancer patients. Hypothesis: The     choline signal as observed by MRS is sensitive to treatment, and a positive response to     treatment will give a reduction in choline concentration.      The purpose of this study is to establish methods for quantification of choline in breast     cancer by MRS   "
180135|NCT00201500|"     The purpose of this study is (1) to examine whether the left ventricular function is impaired     in women with preeclampsia relative to healthy pregnant controls, (2) to examine whether the     endothelial function is impaired in women with preeclampsia relative to healthy pregnant     controls, and (3) to examine whether there is a post partum impairment in left ventricular     and endothelial function.   "
180136|NCT00201513|"     Muscular stability is essential to the spinal column to avoid harmful strain and injury to     its structures. Sudden postural disturbances impose reactive internal forces through the     spine. If the muscles do not react before the internal reactive forces propagate through the     spine, there is a short fraction of time where the spinal column may lack sufficient muscular     support. Studies have shown that in patients with low back pain deep abdominal and back     muscle have a delayed response to reactive forces. The purpose of this study is to verify     these findings and to investigate whether tailored interventions can improve the reaction     time in stabilizing muscle around the lower spinal column i patients with subacute and     chronic low back pain.   "
180137|NCT00201526|"     To describe the broad spectrum of Bipolar Disorder patients admitted to out-patient and     in-patient psychiatric departments in Norway. Include all admitted Bipolar patients both with     and without co-morbid disorders.   "
180138|NCT00201539|"     This is a double -blind randomized crossover study to provide evidence for the expert advice     based recommendation of the Expert Working Group of the European Association for Palliative     Care (EAPC) that patients during treatment with IR morphine are given a double dose at     bed-time that replaces the next 4-hourly dose during night. In addition to the primary,     blinded clinical part of the study, an experimental part is also included. This part consists     of two open study days were morphine IR is given in the same fashion as the clinical study.     The aim is to study whether pharmacokinetic data supports the clinical data.      The use of a double-bedtime IR morphine dose is equal to regularly scheduled IR morphine     every 4-hour during night in respect to pain relief during night for patients with pain     caused by malignant disease   "
180139|NCT00201552|"     Statin could decrease AF burden   "
180159|NCT00202241|"     The main aim of the study is to investigate the combined effects of using anabolic steroids     and protease inhibitors on fat metabolism and body composition of People Living with     HIV/AIDS.      We are seeking to answer the following questions:      1) Are there any significant differences in serum blood lipids, lipodystrophy, in persons     with HIV taking antiretroviral therapies and anabolic steroids versus antiretroviral     therapies alone?   "
180160|NCT00202254|"     The effects of routine rehabilitation in MS patients versus no rehabilitation.   "
180232|NCT00203190|"     Topiramate is a medication that has been approved by the Food and Drug Administration (FDA)     for the treatment of patients with seizures. The trade name for this drug is Topamax®.     Topiramate has not been approved by the FDA for the treatment of cluster headache and is     experimental for the purposes of this research study. If a subject participates in this     study, he/she will increase his/her dose of topiramate rapidly in the first few weeks to try     to stop the cluster attacks and then will continue on a maintenance dose of topiramate in     order to determine if it can prevent attacks from occurring during that cluster period. We     believe that this will lead not only to a faster but a more complete remission of the cluster     period.   "
180141|NCT00201578|"     The use of traditional Chinese herbal medicine and various forms of alternative medicine to     maintain health among the Chinese ethnic group has had a long history and has been deeply     rooted in the Chinese way of living for centuries. It has been a general belief that these     therapies consist of “natural” substances and are less toxic than their western synthetic     drug counterparts. However, recent reports of side effects of systemic traditional Chinese     medicine, including hypersensitivity, hepatotoxicity, neurotoxicity, cardiovascular toxicity,     renal failure, and contact dermatitis, have been increasing.      Since there is a high prevalence in the usage of traditional Chinese herbal medicine in     Taiwan, this study examines the frequency of patients using herbal medicine whose initial     diagnosis in the emergency department (ED) is acute non viral hepatitis. We, the researchers     at National Taiwan University Hospital, then correlate if the cause of hepatitis is related     to the use of these herbal drugs by taking a detailed history of medication or herbs used and     by verifying the contents by chemical analysis of the “medications” used. To our knowledge,     this is the first study in examining the relationship between non viral hepatitis and the use     of herbal drugs prior to arriving at the ED. We expect to prove adverse effects of these     substances, especially hepatitis, is the cause for requiring emergency care.      Our study design is a prospective, density sampling case control study in which one hundred     patients with non viral hepatitis will be recruited as our case. We use a questionnaire     designed by the investigator in the survey of demographic background, education, and income     status of the cases, as well as the frequency of use of the drug, total dosage used, where     the drug was purchased, what the drug is used for, and whether they know of any adverse     effect that the drug might have. If they had taken the drug within three months prior to this     emergency visit, then they are asked to bring the drug in for examination. Examination of the     drug includes the use of high performance liquid chromatography (HPLC) and if necessary,     inductively coupled plasma mass spectrometry (ICP mass). In contrast, our control group     consists of subjects that are admitted to the ED due to trauma or fracture. For each case,     they are matched with two subjects in the control group in both gender and age. They should     also arrive within two days after the arrival of the case. All cases and controls are     screened for viral hepatitis and serology must be negative before entering the study. The     questionnaire is given to both groups. If more than one control is eligible to enter the     study, then the control is chosen by a random draw in a hat. After this use of density     sampling, we collect the data and logistic regression is used for analysis.   "
180142|NCT00201591|"     The study investigated if aerobic endurance exercise of different intensity has different     impact on the physical capacity and myocardial function in patients with coronary artery     disease. Patients with stable CAD trained for 10 weeks, and oxygen consumption and myocardial     function were measured before and after this period. Patients were randomly assigned to each     exercise group.   "
180143|NCT00201617|"     The purpose of this 3-year prospective investigation is to examine the short-term and     long-term (1 year)efficacy of the bone-anchored hearing aid (BAHA) in adults with single     sided deafness   "
180144|NCT00201630|"     To asess the efficacy of Uroxatrol, an alpha blocker in men undergoing prostate brachytherapy     to treat prostate cancer, and whether the use of Uroxatrol in advance of the brachytherapy is     better or not than starting it on the day of surgery.   "
180145|NCT00201643|"     The hypothesis is that administration of two courses of antenatal corticosteroids, compared     to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in     patients delivering prior to 34 weeks' gestation.   "
180146|NCT00201656|"     The purpose of this study is to determine whether retention of cervical cerclage after PPROM     improves latency (without a significant increase in chorioamnionitis) and lessens neonatal     morbidity.   "
180147|NCT00201669|"     This study will determine the efficacy of clofarabine as measured by response rate in     patients with aggressive non-Hodgkin's lymphoma   "
180148|NCT00201682|"     This is a phase I/II study of the combination of etanercept and rituximab in patients with     chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This combination is     proposed to improve the efficacy and diminish the toxicity of this the   "
180149|NCT00201695|"     This study will assess the ability of Doxorubicin, Vincristine and Dexamethasone plus arsenic     trioxide to achieve an overall response rate of greater than 60%.   "
180150|NCT00201708|"     This study will determine if docetaxel will be administered before or after     doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a     subsequent phase III trial.   "
180151|NCT00201721|"     This study aims to assess the rate of complete and overall response using rituximab and     pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this     regimen, and to determine the overall and progression-free survival in CLL patients   "
180152|NCT00201734|"     This study will determine the maximum tolerated dose of the triplet combination of     capecitabine that can be administered in combination with weekly paclitaxel and every four     weeks with carboplatin.   "
180153|NCT00201747|"     To determine the most efficacious of two combination regimens of sequential CPT-11 and MMC in     patients with advanced and previously untreated esophageal and GE junction adenocarcinomas.   "
180154|NCT00201760|"     This study determines the proportion of metastatic breast cancer patients progression free     after 6 months when treated with gemcitabine/ cisplatin/ trastuzumab or gemcitabine/     trastuzumab.   "
180155|NCT00201773|"     To test whether the addition of the COX-2 inhibitor, celecoxib, will decrease the gene     expression of CYP19 in breast cancers collected from postmenopausal women that receive     neoadjuvant exemestane.   "
180156|NCT00202202|"     Can we improve our community partners satisfaction with a change in how psychiatric     consultations are delivered to their clients by our psychiatrist? This survey of users of the     service will compare the level of satisfaction before(retrospectively) to after the way the     service is provided is changed.   "
180157|NCT00202215|"     This is a study to determine if the approach taken to treat patients in the Chrysalis Day     Hospital Program will favourably effect their health status as assessed by Body Mass Index     (BMI)   "
180158|NCT00202228|"     Lactic acidosis is a potentially life-threatening disease associated with the treatment of     chronic HIV infection. Although acidosis is rare, hyperlactatemia is common and may have long     term consequences yet to be recognized. Lactic acidosis is a manifestation of mitochondrial     toxicity; consequences which have yet to be fully recognized and understood. In this study,     we propose to look at lactate clearance and production by two methods, in four treatment     groups, including HIV positive subjects on highly active antiretroviral therapy (HAART)     treatment regimes and without HAART regimes, with liver steatosis and without, and compared     with HIV negative controls. Supplementation with cofactors thiamine, niacin and L-carnitine,     which may have a positive effect on lactate metabolism by facilitating mitochondrial     function, will be studied as well.   "
180191|NCT00202657|"     The purpose of this study is to determine whether patients with Parkinson's disease and     treated with pergolide have a higher risk of heart valve disease compared to patients with     Parkinson's disease not treated with pergolide.   "
180161|NCT00202267|"     Leg ulcers are emotionally distressing and painful, and often require months or years to     heal. Although rarely acknowledged as a pressing health care issue, leg ulcers comprise a     common, complex, and costly condition, managed primarily through community home care     services. Indeed, leg ulcers are the most frequently seen and treated chronic wound. There is     consensus in recent international, evidence-based practice guidelines that graduated,     multi-layer compression is the most effective treatment, and greatly reduces healing time.     High compression is more effective than low compression. However, there is no clear evidence     as to which high compression technology is the most effective in promoting healing, the most     acceptable to patients, or the most cost-effective to the health care system. This study is     designed to answer these questions through a randomized trial conducted in the community,     where most leg ulcer care currently takes place. Issues such as effectiveness in healing,     quality of life, physical discomfort, personal preference, cost to the system and to the     individual will be taken into consideration in evaluating two most commonly used types of     compression bandaging.   "
180162|NCT00202280|"     The purpose of this study is to determine whether Vitamin B12,B6 and Folic Acid are effective     with antipsychotic medication in the treatment of First Episode Psychosis.The B-complex     Vitamins' homocysteine lowering properties may have an effect on cognition and symptoms. We     are examining changes in symptoms and cognition over a 3 month period.   "
180163|NCT00202293|"     Aim: In a population of first episode manic patients with psychotic features, we want to     compare the side effect profile, the degree of adherence and the subjective well being, as     well as the efficacy of two treatments: The standard treatment currently applied (lithium +     chlorpromazine) and an alternative treatment more recently introduced (lithium + olanzapine).     In addition, we want to study retrospectively the development of bipolar disorder and study     prospectively the 6 and 12-month outcome of a cohort of patients presenting a first manic     episode with psychotic features.      Research Background: While the efficacy of lithium in the treatment of acute mania has been     established by numerous studies, it is also known that up to 50% of the patients fail to     respond when it is prescribed alone. It is therefore common practice to complement the     treatment, most commonly with antipsychotics and benzodiazepines. It has been suggested that     antipsychotic agents are faster acting and are superior in controlling hyperactivity compared     to lithium, whereas mood stabilisation is better achieved by lithium, Typical antipsychotics,     such as chlorpromazine, may therefore be useful as adjunctive medication to mood stabilisers,     especially within the first few weeks of treatment of acute mania, and for patients     exhibiting psychotic symptoms or hyperactivity. They however can induce side effects     (somnolence, dizziness, dry mouth, extrapyramidal side effects such as rigidity of the     muscles, and possibly tardive dyskinesia (involuntary movements or contraction of muscles),     as well as akathysia (sense of restlessness). They finally have been suspected to contribute     to the occurrence of post-manic depression. Recent publications in chronic populations have     shown that atypical antipsychotics, such as olanzapine, are also an effective adjunctive     treatment. Olanzapine has the important advantage to induce a very low incidence of     extrapyramidal side effects, including tardive dyskinesia. It can however induce somnolence,     dizziness, dry mouth, and rather commonly weight gain. Moreover, some authors have reported     that olanzapine might induce mania. Both treatments appear then to have positive effects as     well as undesirable side effects. Our project is to compare them. The literature concerning     first episode mania is sparse, particularly in the domain of pharmacotherapy. One     retrospective study showed that 77% of the patients received antipsychotics at discharge and     25% at 6 months follow-up. No comparison has however been made between typical and atypical     antipsychotics, and there are no specific treatment guidelines of first episode mania with     psychotic features.      Project Summary: The hypothesis is that olanzapine and chlorpromazine will have a comparable     efficacy as adjunctive treatment of the acute manic episode with psychotic features. We     however think olanzapine will induce less side effects and will be better accepted by the     patients, and therefore that the adherence to the treatment will be better than with     chlorpromazine. We finally think the subjective sense of well being will be greater with     olanzapine than with chlorpromazine.We will recruit 75 patients at the time of their first     admission for mania with psychotic features at EPPIC. After signature of the informed     consent, we will perform a baseline assessment first to confirm the diagnosis, and second to     evaluate the level of psychopathology. The patients will then be randomly selected to receive     either a treatment of lithium and olanzapine or a treatment of lithium and chlorpromazine. By     the end of the study there will be 37 patients in each group.The patients will go through a     baseline assessment including physical examination and usual laboratory investigation to     exclude any physical illness. They will also go through a one-hour assessment of     psychopathology. Between day 2 and 3 they will go through 2 hours of interview to reassess     diagnosis and personal history. They will thereafter be assessed weekly for eight weeks on     various dimensions: evolution of the intensity of the symptoms, appearance of depressive     symptoms, occurrence of side effects and degree of adherence to the treatment, in an 1-hour     interview. Subjective well being and quality of life will re evaluated at week 4 and 8,     adding 45 minutes to the duration of the interview. This is a flexible dose, open trial,     which means the doctor in charge of the patient will know which medication is being     prescribed, and that he will be allowed to adapt the dosage according to what he feels     necessary. This research project will allow us to organise a more specialised clinic for the     care of first episode manic patients. We will take this opportunity to study carefully the     months preceding the appearance of the first episode in order to try to reconstruct the     prodrome of bipolar disorders. We will also, in an extension phase of the study, look at the     long term outcome (at 6 and 12 months) of a first episode of mania.   "
180164|NCT00202306|"     This study investigates the neuroprotective properties of low-dose lithium in young     individuals at ultra-high risk of developping a first psychotic episode. Fourty individuals     having some symptoms of an emerging psychotic disorders (without meeting the threshold for a     full-blown mental illness) will be treated with a low dose of lithium (about a third of the     dose that is usually used to treat acute mania). We will assess the progression of the     conditions of these individuals on a montly bases for a year. We will do behavioural,     cognitive and imaging assessments prior start of the treatment, after three months and one     year. We hope to demonstrate that low dose lithium will stop or even reverse the progression     of disease. We expect that behavioral, cognitive and in vivo brain imaging parameters in     those individuals treated with low dose lithium improve, compared to the monitoring group.   "
180165|NCT00202319|"     Sedation is an important treatment when caring for the critically ill patient on a     respirator. Adequate sedation has been found to reduce stress, promote relaxation, induce     amnesia, improve the tolerance of the respirator, and generally assist nursing care. However     all sedation produces side effects for the patients. The aim of this study is to measure the     effectiveness of two approaches to sedation management in an Australian Intensive Care unit.   "
180166|NCT00202332|"     Comparison of clinical outcomes in patients undergoing coronary bypass surgery using the     heart/lung machine as opposed to using off-pump techniques.   "
180167|NCT00202345|"     One of the complications of late stage kidney disease is the development of a low red blood     cell count (anaemia/low haemoglobin concentration). The Australian Commonwealth government     limits funding of medications (called erythropoietic stimulating agents) to those patients     who have already developed anaemia.      There is evidence supporting the beneficial effects of maintaining a higher haemoglobin in     these patients. Higher haemoglobin can delay the onset of dialysis and reduce the development     of heart enlargement. However, the administration of erythropoietic stimulating agents is not     without risk, including a high financial burden, worsening of high blood pressure and a rare     complication called pure red cell aplasia.      Previous studies have shown that patients with chronic kidney disease require additional iron     to maintain the production of red blood cells. Thus it would be timely to determine if the     administration of iron sucrose to these patients can maintain a near normal haemoglobin     concentration, without the need to start an erythropoietic stimulating agent and possibly     delaying dialysis.      Study Hypothesis: That administration of iron sucrose is superior to standard care in the     prevention of anaemia in patients with stage 3 /4 kidney disease.   "
180168|NCT00202358|"     Studies have shown that beta-blockers such as atenolol when given in the perioperative period     reduce morbidity and mortality. One study showed that atenolol given just during the surgery     period, seemed to improve outcomes up to 2 years later. This is hard to explain since     beta-blockers act on the body by blocking the effects of adrenalin and thereby lowering heart     rate and blood pressure.      This study is designed to find out if perioperative atenolol might exert its long term     effects through an anti-inflammatory mechanism rather than by lowering heart rate and blood     pressure. It is known that inflammation increases after surgery as part of the healing     process. However, it is also becoming clear that low-grade chronic inflammation can also lead     to long term adverse effects.   "
180169|NCT00202371|"     The goal of this study was to compare a restrictive RBC transfusion policy (a Hb transfusion     trigger: 7.2 gr/dl) with a more liberal RBC transfusion policy (a Hb transfusion trigger: 9.6     gr/dl) on physical fatigue.   "
180170|NCT00202384|"     Clinical and experimental evidences suggest that there is a variability in therapeutic     response to immunomodulating therapies in Multiple Sclerosis patients.      Microarrays is a technology that permits to monitor the expression levels of thousands of     genes at a time.      The specific aim of this study is to identify predictive factors of therapeutic response in     MS patients treated with high-dose Interferon-Beta.   "
180192|NCT00202670|"     The aim of this study is to determine in high risk diabetics if the positive predictive value     of stress echocardiography is superior to the positive predictive value of stress     scintigraphy in the diagnosis of coronary stenosis > 50%.   "
180226|NCT00203112|"     This study investigates the add-on effect of oral minocycline in subjects treated with daily     injection of Copaxone. Copaxone and minocycline are thought to have differential modes of     actions that may complement each other in treating MS symptoms.   "
180228|NCT00203138|"     Patients who completed the study TVP-1012/232 are eligible to enter the extension study to     continue their rasagiline therapy for their Parkinson's disease (PD). During this study the     patient's safety, tolerability of rasagiline, and effectiveness of this therapy will be     monitored.   "
180229|NCT00203151|"     It is thought that Edratide may be able to reduce the symptoms of SLE.   "
180230|NCT00203164|"     This is a study to look at the effectiveness, tolerability, and safety of one dose of     rasagiline in advanced Parkinson's disease (PD) patients who have been treated with     Levodopa/Carbidopa therapy.   "
180171|NCT00202397|"     Cerebellar disorders are often disabling and symptomatic therapies are limited to few options     that are partially effective. It seems therefore appropriate to search for additional     approaches.      Purkinje cells are the sole output of the cerebellar cortex: they project inhibitory signals     to the deep cerebellar nuclei (DCN), which have a critical role in cerebellar function and     motor performance. DCN neurons fire spontaneously in the absence of synaptic input from     Purkinje neurons and modulation of the DCN response by Purkinje input is believed to be     responsible for coordination of movement. Recent evidences support the notion that an     increase in DCN excitability may be an important step in the development of cerebellar ataxia     and point to the underlying molecular mechanisms: the inhibition of small-conductance     calcium-activated potassium (SK) channels, that causes an increase of the firing frequency in     DCN, correlates with cerebellar ataxia.      The rationale of the present project is that SK channel openers, such as riluzole, may have a     beneficial effect on cerebellar ataxia.      The researchers propose to perform a pilot study investigating safety and efficacy of     riluzole, an approved treatment for amyotrophic lateral sclerosis, as a symptomatic approach     in patients with chronic cerebellar ataxia.   "
180172|NCT00202410|"     The frequency of auto-immune diseases (including multiple sclerosis) is increasing in     industrialised countries.      According to an hypothesis which is receiving a wide international credit, this may be due to     the fact that the populations of these countries are increasingly less exposed to microbes     further to the improvement of hygienic conditions and to the use of antibiotics.      If exposure to microbes is lacking, also their regulatory function is missed with a     consequent possible onset of auto-immune symptoms.      For this reason, it is deemed that by exposing the immune system of a patient to an ancient     microbe, being complex and important in man evolution, like the Tuberculosis Mycobacterium,     it is possible to rebalance the immune system.   "
180173|NCT00202423|"     This is a 10-week, randomised, double blind, placebo-controlled, crossover trial to     investigate the effect of Cannabis Based Medicine Extract (Sativex) on patterns of brain     activation associated with movement in 20 MS patients suffering from lower limb spasticity.     Spasticity is a common symptom in Multiple Sclerosis (MS), occurring all over the course of     the disease, particularly in the progressive phase.Physiologically, spasticity and     hyperreflexia habitually seen in patients with pyramidal syndrome is due to lesions of other     descending pathways, such as the cortico reticulospinal pathways, which participate in     voluntary movements.It is now known that an endocannabinoid system acts in humans by at least     two types of cannabinoids receptors, CB1 and CB2. There is evidence to support the view that     the psychoactive ingredient in cannabis, delta 9-tetrahydrocannabinol (delta 9-THC), and     cannabinoids in general, can reduce muscle spasticity in people with MS. Aim of the study     will be to evaluate the effect of Sativex on: (i) patterns of brain activation associated     with movement (fMRI) in MS patients suffering from spasticity; (ii) changes in level of     spasticity (H-reflex); (iii) changes in intracortical excitability and on synaptic     intracortical network of the motor areas (double shock TMS).   "
180174|NCT00202436|"     In this project we plan to evaluate the effectiveness of erythrocytapheresis against     phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction     in patient burden. Aspects of cost effectiveness will be included in the final analysis.     Results of the study would allow decision-making based on Evidence Based Medicine on the     best therapeutic options available for newly-diagnosed as well as existing primary     hemochromatosis patients.   "
180175|NCT00202449|"     The purposes of this study are:        -  to evaluate the efficacy and tolerability of the drug prazosin compared to placebo for          combat stress-related nightmares, sleep disturbance and overall function in recently          combat-exposed returnees from Operation Iraqi Freedom (OIF) and Operation Enduring          Freedom (OEF).        -  to evaluate the effects of the selective serotonin reuptake inhibitor (SSRI) paroxetine          on behavioral symptoms and overall function in this population.   "
180176|NCT00202462|"     We hypothesize that testosterone replacement will improve mood and quality of life in older     men with low testosterone and mild depression. Study subjects will receive either     testosterone gel or a placebo (inactive) gel for 12 weeks. Neither the subject or the     investigator will know whether they are receiving placebo or testosterone gel. At the end of     the initial 12 week period, all subjects will receive testosterone gel for 12 more weeks.     Mood and quality of life measures will be obtained at baseline, at the end of the     double-blind phase and at the end of the extension phase (when all subjects receive     testosterone.)   "
180177|NCT00202475|"     The project will determine the advantages of double erythrocytapheresis in the collection of     preoperative autologous erythrocytes as compared to the standard collections of whole blood.     The study will assess the total reduction in the number of procedures required to obtain the     preoperative units ordered by the surgeon. Also, successfulness of erythrocytaphereses versus     classical whole blood collection for these patients will be compared.   "
180178|NCT00202488|"     The purpose of this study is to determine if Helicobacter pylori (H. pylori) gastritis     results in abnormal iron metabolism in patients with iron deficiency anemia (IDA), and to     determine if this is due to strain variations in the H. pylori organism.   "
180193|NCT00202683|"     This study is is the first step of a full study named CHEMOGENE because it explores the     genetic determinant of an alteration of the chemoreflex. This reflex determines     hyperventilation when the pressure of oxygen falls in the blood. This happens when subjects     travel to high-altitude where oxygen levels diminish in the atmosphere. Subjects with such an     altered chemoreflex are intolerant to altitude and develop pulmonary or cerebral edema     associated with a severe headache. In this study we compare subjects tolerant to high     altitude (8000 meters)to subjects intolerant to altitude. The chemoreflex is measured i.e.     the hyperventilation associated with hypoxia and all subjects are scanned for the genes     implicated in the mitochondrial respiratory chain. The idea is that subjects with an impaired     oxygen sensing will exhibit an altered chemoreflex and will be intolerant to high-altitude.   "
180194|NCT00202696|"     To determine if nalmefene is safe and effective in smoking cessation.   "
180195|NCT00202709|"     The purpose of this study is to find out if Thought Field Therapy has effect on certain     anxiety disorders; agoraphobia, social phobia, and post traumatic stress disorder (PTSD).   "
180227|NCT00203125|"     This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg     of Rasagiline or Placebo   "
180179|NCT00202501|"     MAIN AIMS: to analyze the efficacy of nasal CPAP treatment in patients with ischemic     first-ever stroke and Sleep Apnea Syndrome (SAS) in terms of: early neurological outcome,     functional recovery, quality of life influence, stroke recurrence and survival.      SECONDARY AIMS: to evaluate the feasibility of the treatment in this type of patients at     short and long time.      DESIGN: clinical randomized case-control study.      PATIENTS: younger than 75 years with a First-Ever stroke with at least one of the following     criteria: snoring, observed apnea, Hypertension or Ischemic Cardiopathy.      MEASUREMENTS: protocol to define subtype stroke and parenchymatous and vascular location;     sleep questionnaire (including Epworth Sleepiness Scale); Respiratory Polysomnography (RPSG).     If RPSG shows an AHI > 20, with predominant obstructive events, patients will be randomized     in a CONTROL GROUP (conventional treatment) and a TREATMENT GROUP (with Nasal CPAP). Follow     up for both groups at 1, 3, 12 and 24 months will include: early neurological outcome, body     mass index (BMI), blood pressure (BP), functional recovery (Barthel Index/Canadian Scale),     quality of life (SF36), recurrences, vital status. Nasal CPAP titration will be performed by     means of an automatic system (Autoset Portable ST). Compliance will be recorded. If a     negative RPSG is obtained (AHI < 10) (NO SAS GROUP) or with AHI < 20 (mild SAS) the usual     treatment and the same follow up protocol will be established.      STATISTICS: the sample size is initially calculated in 10 patients for each group,     considering this is part of a multicenter study including 8 centers. If no differences are     found, depending on the statistical power the investigators will consider including more     patients. The different groups will be compared for the analyzed variables with the     corresponding tests.   "
180180|NCT00202514|"     The purpose of this study is to test the safety and effectiveness of an extended release form     of a medication called divalproex sodium (Depakote ER) for the treatment of people with     alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce     symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder     and other mental health disorders. This study will test the hypothesis that divalproex sodium     will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn     reduce relapse and craving for alcohol.   "
180181|NCT00202527|"     AIMS:To know the effects of the treatment with nasal positive continuous airway pressure     (CPAP) on systemic blood pressure and the expression of biological mediators, in systemic     hypertension of recent diagnostic, whose have an apnea-hypopnea index > 15.      METHODOLOGY: DESIGN: Prospective, multicenter, randomized study, of parallel groups and     controlled with placebo, in patients diagnosed of systemic hypertension (SH) with an     apnea-hypopnea index, by conventional polysomnography > 15. A total of 340 patients with     recently diagnosed of SH and without any pharmacological treatment will be studied. All     patients will be randomized to receive, alternatively, CPAP treatment with optimal pressure     titled with a proved system, or Sham-CPAP for 12 weeks.      MEASUREMENTS: A) Conventional polysomnography at baseline: B) Clinic: sleepiness (ATS, Basic     Nordic Sleep Questionnaire and Epworth), quality of life (EuroQol); C) 24 hour blood pressure     monitoring; D) Expression of biological mediators in blood: general determinations,     endothelial, inflammatory, lipid, renin-angiotensin-aldosterone and adrenergic mediators.      ANALYSIS. Baseline measurements of all the variables will be compared with the situation at     six and twelve weeks. We will use the chi square test and the Fisher´s exact test     (categorical variables), the t test for continous variables and repeated measures ANCOVA for     the primary objective. The analyses will be done under the criterion of intention to treat     and for protocol. The variables will be controlled by the compliance with the CPAP..   "
180182|NCT00202540|"     The purpose of this study is to demonstrate a long term efficacy of S18986 versus placebo on     episodic memory performance in patients with MCI   "
180183|NCT00202553|"     The aim of the study is to assess the acceptability, safety and pharmacokinetics and effects     on blood pressure of a paediatric formulation of perindopril given in hypertensive children   "
180184|NCT00202566|"     To test whether ivabradine when given in combination with atenolol is able to improve the     exercise tolerance of patients with stable angina pectoris   "
180185|NCT00202579|"     To evaluate the effects on heart function of ivabradine administered to patients with severe     chronic heart failure   "
180186|NCT00202592|"     The aim of the study is to assess the long-term safety and effects on blood pressure of a     paediatric formulation of perindopril in hypertensive children   "
180187|NCT00202605|"     The purpose of the study is to evaluate how safe and how well SPD465 works compared to     placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration     of clinical benefit.   "
180188|NCT00202618|"     The purpose of this trial are to evaluate the reduction of urinary albumin excretion by an     angiotensin receptor blocker (ARB), valsartan, in comparison with a calcium channel blocker     (CCB), amlodipine, in Japanese hypertensive patients with type 2 diabetes mellitus and     microalbuminuria under strict blood pressure control, and to compare the additional effects     of an ARB or a CCB in combination with angiotensin-converting enzyme (ACE) inhibitor     treatment.   "
180189|NCT00202631|"     People with high spinal lesions are at risk of respiratory complications because they have     partial or complete paralysis of breathing muscles. Previous work has shown that tetraplegic     lung volumes can be increased by using abdominal FES during expiration. The technique is     attractive because it is non-invasive, painless in tetraplegia and completely reversible. It     may provide a treatment for augmenting the patient’s breathing both in the acute presentation     of spinal injury (when half of cervical injuries require ventilation) and in long term     management of tetraplegia and high paraplegia. We propose a pilot study in a small group of     subjects to see if the technique is feasible from both a clinical and engineering viewpoint.     The aims of the study are: 1)To examine the effects of abdominal FES on lung mechanics and     gas exchange in tetraplegic subjects. 2)To optimise the stimulation pattern and intensity via     electronic stimulators and to design a trigger to allow the FES to follow the subject’s own     breathing cycle automatically.   "
180190|NCT00202644|"     Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to     be produced. Platelets are small cells carried around in the blood, which help form blood     clots. When patients have too many platelets, there is a risk of blood clots forming     unnecessarily and excessive bleeding. The aim of this study is to gain additional information     on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as     hydroxycarbamide).   "
180196|NCT00202722|"     Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by     non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of     remifentanil used as analgesia during labour. Intravenous patient controlled analgesia     (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a     lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate,     SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was     recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were     assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives     also recorded their impression of the parturients pain. The parturients level of sedation     were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered     at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and     concentration of remifentanil were performed. After delivery, both mother and midwife     evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were     sufficient, nausea, vomiting, level of sedation and dizziness.   "
180197|NCT00202735|"     Dislocation of the glenohumeral joint is the most common traumatic joint dislocation. The     usual treatment of first time traumatic anterior dislocation of the shoulder is reduction     followed by immobilization in a sling for a period of one to three weeks. The incidence of     recurrence is high and age at the time of primary dislocation is the chief prognostic factor     in determining the risk of recurrence. There is no agreement according to the effect of     immobilization,neither to the length of immobilization time. The Bankart lesion with avulsion     of the inferior-anterior capsulolabral complex is almost invariably present in patients with     anterior shoulder dislocation. Recent and ongoing studies by Eijii Itoi et al,Akita     university Japan, gives evidence of the immobilization with the arm held in external rotation     may reduce the risk of subsequent instability by approximating the Bankart lesion to the neck     of the glenoid giving a more anatomical healing. We have started a prospective randomized     study. The patients are assigned to two groups with informed consent. One group are     immobilized in internal rotation for 3 weeks and the second group are immobilized in external     rotation for 3 weeks. We will compare the rate of relaxation between the groups. Because age     is the main prognostic factor we use stratified randomization with two age groups: One group     of patients aged between 16 and 24 years and one group aged between 25 and 40 years.The time     of observation after initial treatment will be 2 years with follow up after 4 and 10 years.     Eleven hospitals and two primary trauma care centers in Norway participate in the study. A     subgroup of 50 patients are also planned to be examined with CT and MRI.   "
180198|NCT00202748|"     We know that changing lifestyle can prevent type 2 diabetes. The challenge is how to help     people changing their lifestyle. We have people in 2 groups: half of them is meeting in grops     of 10 persons (interventiongroup), the other ones are just visiting their doctor     (controlgroup).   "
180199|NCT00202761|"     The purpose of this study is to document that taking part in this program is beneficial for     the child, its parents and local professionals.      The study hypothesis are:      Intensive training will speed up the childs motor, cognitive and social development.      Intensive habilitation will increase the childs family's empowerment Children having     participated in this intensive habilitation will speed up their process of development     further than children in the control group The cooperation between first and second line     health service is strengthened by participation in the intensive habilitation program The     professionals in the first line(community)in Norway that participates in this program     increases their empowerment and motivation   "
180200|NCT00202774|"     The purpose of this study is to determine time to disease progression of combination therapy     with capecitabine and oxaliplatin (XELOX) vs. oxaliplatin and 5-fluorouracil in continous     infusion (5-FU CI) as first line treatment in advanced or metastatic colorectal cancer   "
180201|NCT00202787|"     The purpose of this study is to determine confirmed objective response rate to combination     therapy with cetuximab and FOLFOX4 or FOLFOX4 alone in patients with CRC and non-resectable     hepatic metastases   "
180202|NCT00202800|"     Pancreatic cancer is a devastating disease. Previous research shows a correlation between a     specific oncogene change (ras-mutation) and enhanced sensitivity to two chemotherapy drugs     combined: gemcitabine and etoposide. This Phase II trial will evaluate this drug combination     for locally advanced and metastatic pancreatic cancer.   "
180203|NCT00202813|"     This study should help determine to determine whether or not the use of an antibiotic coated     catheter will significantly reduce the number of central line related bloodstream infections     in children requiring a CVC. This study may also determine if antibiotic coated catheters     will be significantly less likely than non-antibiotic coated catheters to allow bacteria to     live (colonize) in/on the catheter.      The use of central venous catheters (CVC) is paramount to the care of critically ill     children. Thus, in the pediatric intensive care unit (PICU), these catheters are widely used     in situations when more than peripheral venous access is necessary. This central access     allows the delivery of fluids, e.g, blood, medications, etc. as well as serves as a means to     withdraw blood. It has been estimated that more than 250,000 nosocomial bloodstream     infections occur each year, with 90% of these associated with the use of CVCs. More recently,     the National Nosocomial Infection Surveillance System (NNIS) reported during 1992-2001     CVC-associated bloodstream infections (BSI) in ICU settings occurred at rates of 2.9-11.3 BSI     per 1,000 catheter days. The cost of treating CVC related BSI has been estimated to be in     excess of $28,000 per catheter. In the adult medical literature, there is strong evidence     supporting use of antiseptic or antibiotic coated catheters to reduce the cost of     hospitalization for CVC related infections. Cost-benefit studies have suggested that if the     baseline incidence of CVC BSI is >0.4 BSI per 1000 catheter days, $59,000 will be saved, 7     cases of BSI will be avoided, and 1 death prevented for every 300 anti-septic impregnated     CVCs used.   "
180220|NCT00203034|"     Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either     Rasagiline or Placebo   "
180221|NCT00203047|"     This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and     add-on pulse steroids.   "
180222|NCT00203060|"     Study to look at the effectiveness, tolerability and safety of two doses of Study Medication     in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa.   "
180204|NCT00202826|"     The purpose of this study is to determine the best treatment for children with a fluid     collection in the chest associated with an underlying pneumonia. Researchers generally agree     that a child with a large fluid collection in the chest need to have the fluid drained in     addition to anitbiotics. There have been many treatments studied in children that have been     shown to be effective and safe, but the treatments have never been compared to each other in     a randomized controlled study.      The optimal treatment of pediatric parapneumonic effusions remains controversial. The     objective of this study is to compare the use of conventional management (antibiotics with     thoracostomy tube placement) with primary thorascopic drainage (see protocol). Our hypothesis     is that pediatric patients with parapneumonic effusion, regardless of pleural fluid     composition and loculations, have decreased morbidity when treated with early thoroscopic     adhesiolysis (VATS) compared with conservative treatment.   "
180205|NCT00202839|"     This is an open-label, randomized, comparative, multicenter, 48-week study designed to     evaluate the efficacy and safety of combination treatment with pegylated interferon and     ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C     virus (HCV)-ribonucleic acid (RNA) positive) (Genotype 1). All subjects will complete 24     weeks of treatment, termed the Pilot Treatment Program, after which all eligible subjects     will be randomly assigned to one of two study groups. One group will be followed for an     additional 48 weeks without study medication, while the other will be continuously treated     for an additional 24 weeks and then followed for another 24 weeks without study medication.     Sustained virologic response, defined as undetectable HCV-RNA in serum at the end of the     follow-up period, will be measured along with other outcomes.   "
180206|NCT00202852|"     Prior to the first infusion, patients will be randomized into one of two groups (placebo or     infliximab). All patients will continue to receive the same does of methotrexate (MTX) during     the study as received prior to the study. The objective of the study is to evaluate the     efficacy and safety result of infliximab with Korean patients in reducing clinical signs and     symptoms of rheumatoid arthritis (RA) at 30 weeks following the onset of treatment and to     review whether the result is comparable to the result of the ATTRACT trial.   "
180207|NCT00202865|"     This is a randomized, double-blind, multi-center, placebo-controlled study with two parallel     treatment groups (placebo and infliximab) in subjects with ankylosing spondylitis (AS) to     evaluate the efficacy of infliximab 3 mg/kg.   "
180208|NCT00202878|"     This is a randomized, active-control, double-blind study of subjects with stabilized     high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical     benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in     the United States) compared with Simvastatin 40 mg. As per the original protocol, if     low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin     in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011     protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new     increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the     reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV)     death, major coronary events, and stroke.   "
180209|NCT00202891|"     This open-label, randomized, parallel-group clinical study is designed to compare the     efficacy and safety of the topical antibiotic, sisomicin cream, with that of another topical     antibiotic cream, nadifloxacin cream, in the treatment of Indian patients with primary     pyodermas.   "
180210|NCT00202904|"     This is a multicenter, randomized, parallel group, placebo controlled study designed to     evaluate the efficacy, safety, and tolerability of ezetimibe added to ongoing atorvastatin     therapy compared with ongoing atorvastatin treatment alone. This study will involve subjects     with primary hypercholesterolemia and coronary heart disease (CHD) who are currently being     treated with atorvastatin and who would benefit from additional reduction in low-density     lipoprotein cholesterol (LDL-C).   "
180211|NCT00202917|"     The purpose of this study is to study the feasibility and Toxicity of allogeneic     haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a     dose reduced conditioning.   "
180212|NCT00202930|"     The purpose of this study is to evaluate the feasibility of giving four weekly doses of     Rituximab (anti-CD20 antibody) in the treatment of children with refractory neuroblastoma     associated opsoclonus-myoclonus. Patients must have continued symptoms of opsoclonus,     myoclonus and or ataxia despite surgical resection and a minimum of one month of steroid     therapy. Evaluations include clinical symptoms of opsoclonus-myoclonus and ataxia as well as     detailed evaluation of learning and development.   "
180213|NCT00202943|"     We hypothesis that radiofrequency will cause less post-operative discomfort when compared     with laser assited uvulopharyngoplasty. 40 patients with primary snore will be enrolled into     this study. After overnight sleep test confimred that no obstructive sleep apnea existed,     cases were informed consented. Then they were randomized into two groups. Post-operative     pain, duration of analgesics were recorded.   "
180214|NCT00202956|"     The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal     patients with osteoporosis.   "
180215|NCT00202969|"     This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating     the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared     with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with     chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A),     S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced     distribution of patients to each arm according to following stratifications, performance     status (0, 1, or 2), the number of metastatic sites (1 vs >1), prior gastrectomy, and center.   "
180216|NCT00202982|"     This is a study to test if a new higher dose of Copaxone is more effective in treating     relapsing-remitting multiple sclerosis than the currently available 20 mg dose.   "
180217|NCT00202995|"     Randomized study designed to look at the difference in relapse rates between patients     remaining on their current interferon medication and those switched to Copaxone®   "
180218|NCT00203008|"     Patients with Parkinson's disease will be seen by a dermatologist who will biopsy any     suspicious skin lesions.   "
180219|NCT00203021|"     Patients have scheduled visits every 3 months to assess Copaxone safety and their Multiple     Sclerosis status.   "
180233|NCT00203203|"     This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear     stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular     Ejection Fraction (LVEF) of less than or equal to 45%. Once the patient meets all inclusion     criteria, and no exclusion criteria are found, the subject is consented for the study, and     extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline     testing criteria is met, the patient has their own bone marrow harvested and later that day     the subject is taken to a cardiac catheterization lab where left ventricular     electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed     stem cells are injected under electromechanical guidance into the affected areas of the left     ventricle. The patient is usually discharged home the next day and returns for follow up     visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4,     5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits,     including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell     injection.   "
180234|NCT00203216|"     The study drug levetiracetam is FDA approved as an add-on medication in the treatment of     partial onset seizures in adults with epilepsy. The trade name is Keppra®. This is an     open-label trial, which means that all participating patients will receive active study     drug.      The Jefferson Headache Center has developed this clinical study to evaluate the safety and     effectiveness of levetiracetam in preventing migraine headaches, with or without aura (visual     disturbances).      In addition, the study site will be performing a procedure called Transcranial Magnetic     Stimulation (TMS). This procedure measures brain activity because it is thought that people     with migraine experience periods of cortical hyperexcitability or over-activity in the brain.     This information may help physicians in the future determine which preventive medications     will work for which patients.   "
180235|NCT00203229|"     This research study will look at the safety (e.g., the occurrence of side effects) and     efficacy (how well the drug works in reducing trigeminal neuralgia attacks) of a drug called     lamotrigine in adults with trigeminal neuralgia.   "
180236|NCT00203242|"     The purpose of this study is to collect and evaluate information on the use of Depakote     Extended Release (ER) and Depacon Intravenous (IV) in patients with cluster headaches.     Patients who are currently in a cluster cycle will be treated with 2 consecutive days of IV     Depacon followed by oral Depakote ER. Patients will receive a total of 1,000mg of Depacon and     1,000mg of Depakote ER each day. Patients may have a 3rd day of IV Depacon followed by oral     Depakote ER if the primary investigator believes it to be beneficial. The patient is then     sent home on oral Depakote ER. The dose of Depakote ER can range from 500mg to 2,000mg this     dose is to be determined by the primary investigator. The patient will continue the oral     Depakote ER until the end of their cluster cycle or for a maximum of 6 weeks, which ever     comes first.   "
180237|NCT00203255|"     The purpose of this trial is to study the use of soy isoflavones in the prevention of     menstrually-associated migraines. Additionally, this trial may provide insight into the     menstrual cycle and menstrually-related headaches in women. With this information, we may be     able to change current treatment methods or even develop new methods in order to advance     current approaches in the treatment of menstrual migraine.   "
180238|NCT00203268|"     This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It     will be used to treat two migraine attacks in subjects who have a history of skin sensitivity     associated with their headaches.This skin sensitivity is called cutaneous allodynia     (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a     non-noxious stimulus is applied to normal skin. It has been noted in several studies that in     subjects with migraine, seventy nine percent of the subjects experienced allodynia on the     facial skin on the same side as the headache. It has also been shown that that once allodynia     develops, other migraine medicines that would normally be very effective for migraine pain,     become much less effective or ineffective. This study will compare the differences,if any, in     attacks treated early with this study drug and treated later with the same study drug. It is     hoped that that this trial will provide information on the use of DHE-45 in subjects who have     cutaneous allodynia. Understanding more about allodynia may help us understand how the pain     system works in migraine.   "
180239|NCT00203281|"     Based on the limited amount of experience with plasmapheresis and CytoGam concomitant use,     the researchers seek to evaluate the pharmacokinetics (drug absorption, distribution, and     elimination) of this therapy. The researchers are also interested in evaluating the     pharmacokinetics of the various immunosuppressant medications that patients will receive such     as tacrolimus, mycophenolate mofetil and daclizumab.   "
180257|NCT00203541|"     The primary objective of this pivotal study is to determine if a new antimicrobial dressing,     applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased     cumulative incidence rate(CI) of localized, superficial infections at the sternal incisional     site as compared to the control group, regular, non-antimicrobial dressing.   "
180240|NCT00203294|"     Subjects are scheduled to undergo a Greater Occipital Nerve Block (GONB) as treatment for     your chronic daily headache (CDH). GONB has been used for many years in the treatment of     headaches. The nerve block is done by injecting a liquid drug through the skin of the back of     the head to the area of the greater occipital nerve. The nerve runs superficially in this     area, therefore the drugs are injected just under the skin. The injected drugs block     electrical transmission through the nerve, resulting in reduced head pain. There are     treatment options for patients receiving a GONB, however, some clinicians use local     anesthetics (lidocaine and /or bupivicaine) alone, and some use local anesthetics with local     steroid injection. The purpose of this study is to evaluate whether or not there is an     observed difference between these two treatment approaches for GONB. We expect to enroll 60     patients into this research study at Thomas Jefferson University only.   "
180241|NCT00203307|"     Olanzapine (o-lan-zah-peen) is a medication that has been approved by the Food and Drug     Administration (FDA) for the treatment of patients with schizophrenia and/ or bipolar     disorder. The trade name for this drug is Zyprexa®. Olanzapine has not been approved by the     FDA for the prevention of migraine and is experimental for the purposes of this research     study.      The Jefferson Headache Center at Thomas Jefferson University has developed this clinical     study to evaluate the safety and effectiveness of Olanzapine in preventing migraine     headaches.   "
180242|NCT00203320|"     It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been     implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised     to be of potential benefit for treating AD.   "
180243|NCT00203333|"     People with epilepsy are at a higher risk for sudden unexpected death than the general     population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this     population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is     particularly high for those with refractory epilepsy. Several lines of evidence support a     cardiac mechanism for SUDEP.      This study plans to determine:        1. the frequency and types of cardiac arrhythmias that occur in this population and        2. whether these are increased above the general population in the same age group.      Additionally, these data will be correlated to specific clinical data, including seizure     history, anticonvulsant medications, and any accompanying clinical symptoms.   "
180244|NCT00203346|"     Migraine and the skin sensitivity that accompanies it can go away in minutes after a nerve     block, which is a procedure involving an injection of a small amount of a local anesthetic     next to a nerve to the skin, causing an area of skin to become numb. We have also noticed     that light sensitivity goes away quickly after a nerve block. We would like to see how     quickly this happens and how long the benefit of nerve block lasts. We are interested to see     if these effects are due to the injection itself or due to the lidocaine.      A subject may be asked to participate in this study if a subjects physician has planned for a     subject to receive an injection of BOTOX® in the area of the Greater Occipital Nerve (a     spinal nerve located at the back of the head) as part of a subjects routine preventive     treatment for migraine today.   "
180245|NCT00203359|"     It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been     implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised     to be of potential benefit for treating AD.   "
180246|NCT00203372|"     The purpose of this study is to evaluate the safety of the TAC-bevacizumab combination and     investigate whether changes in gene expression, or the expression of specific biomarkers, are     either predictive of response to bevacizumab or indicative of response.   "
180247|NCT00203385|"     The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote)     in the continuation treatment of PTSD.   "
180248|NCT00203411|"     The purpose of this study is to evaluate the safety and effectiveness of the bevacizumab and     capecitabine combination in frail patients with untreated metastatic colorectal cancer.   "
180249|NCT00203424|"     The purpose of this study is to evaluate the safety and effectiveness of bevacizumab plus     erlotinib following radical prostatectomy.   "
180250|NCT00203450|"     The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg     - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a     body mass index (BMI) of >25 and are on a psychotropic medication with a known side effect of     weight gain.   "
180251|NCT00203463|"     To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD.   "
180252|NCT00203476|"     To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA     Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or     niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol     Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density     lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures     examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis.     High-density lipoproteins (HDL) elevations are monitored between the three groups to     determine efficacy as a secondary outcome.   "
180253|NCT00203489|"     The purpose of this study is to determine if a new antimicrobial gauze dressing is better     than the current method of dressing open wounds with plain sterile gauze. It is hoped that     the antimicrobial gauze will reduce the number of germs in the open wound and even improve     the rate of healing.   "
180254|NCT00203502|"     The main purpose of this study is to find out what effects taking the drug bevacizumab     together with two chemotherapeutic agents, docetaxel and cyclophosphamide followed by     doxorubicin alone before surgery will on breast cancer. Bevacizumab will be given for twelve     weeks in combination with chemotherapy then it ill be held during the administration of     doxorubicin. Twenty-eight to fifty-six days after undergoing surgery, all patients will     receive nine three-weekly infusions of bevacizumab.   "
180255|NCT00203515|"     The purpose of the study is to determine if the commercially available device called the     DOVER™ Silver Foley catheter prevents infections of the urinary tract.   "
180256|NCT00203528|"     The primary objective is to evaluate the safety and efficacy of divalproex extended release     (ER) compared to risperidone in the treatment of bipolar disorder with comorbid substance use     disorder   "
180258|NCT00203554|"     The purpose of this study is to compare the effect of vertebroplasty with that of traditional     medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.   "
180260|NCT00203580|"     The purpose of this study is to assess the long-term treatment of patients with proximal     venous thrombosis through the administration of subcutaneous low-molecular-weight heparin     (tinzaparin sodium) versus the standard care use of intravenous heparin followed by oral     warfarin sodium.   "
180261|NCT00203593|"     The purpose of this study is to determine whether eight weeks of exercise performed at an     intensity of approximately 65% VO2max will improve symptoms associated with fainting     (vasovagal syncope).   "
180278|NCT00203814|"     The purpose of this study is to determine the efficacy of sulfadoxine-pyrimethamine plus     artesunate versus sulfadoxine-pyrimethamine alone in the treatment of uncomplicated malaria.   "
180279|NCT00203827|"     The purpose of this study is to develop a questionnaire that can be used for standardized     patient information gathering in the clinical setting. This will serve as the information     source for a pediatric sleep database.   "
180280|NCT00203840|"     The information gathered from normal pediatric patients seen at the Pediatric Neurology     Clinic in the DCAM and LaRabida Children's Hospital will be used to standardize and validate     the information gathered from pediatric patients with sleep disorders. This will serve as the     information source for a pediatric sleep database.   "
180262|NCT00203606|"     Hepatitis C infects as many as 300,000 Canadians. Up to 25% of those infected will develop     cirrhosis and be at risk for liver failure and liver cancer. Cirrhosis caused by hepatitis C     is the most common reason for liver transplantation in Canada. The largest group of infected     people are those who use injectable street drugs. However, people who continue to use drugs     are routinely excluded from scientific studies testing new treatments for Hepatitis C and are     generally recommended not to receive available treatments. Although several reasons are given     to justify excluding these people from treatment, little scientific evidence is available to     support it. We plan to examine how successful treatment with the current standard treatment     of pegylated interferon and ribavirin is in those who continue to use injection drugs. We     will compare the results of treatment of 70 active drug users to results of published     clinical trials (this is a change from initial plan to compare to treatment results of 70     local) reformed drug users). Our goal is to determine whether reasonable success rates can be     achieved in active drug users that would then further justify their routine treatment.   "
180263|NCT00203619|"     The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule     endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To     inform this analysis, a randomized controlled trial of capsule endoscopy compared with     standard care will be conducted   "
180264|NCT00203632|"     The purpose of the study is to determine if the addition of rosiglitazone to subjects with     fair glucose control on other oral agents improves endothelial function, a surrogate marker     of vascular health.      It is hypothesized that improving whole body insulin sensitivity with combination therapy     including rosiglitazone will restore the vascular actions of insulin and improve     endothelium-dependent vasomotion more effectively than placebo in patients with diabetes     mellitus.   "
180265|NCT00203645|"     The purpose of the study is to examine whether problem gamblers who receive therapy calls in     addition to a self-help manual will be more likely to quit or cut back on their gambling when     compared with problem gamblers who receive just the manual.   "
180266|NCT00203658|"     The purpose of this study is to assess the long-term out-of-hospital treatment of patients     with proximal venous thrombosis through the administration of subcutaneous     low-molecular-weight heparin (tinzaparin sodium) versus low-molecular-weight heparin followed     by warfarin sodium.   "
180267|NCT00203671|"     The purposes of this study are:        -  To review past clinical use of mycophenolate mofetil (MMF) in kidney transplant          patients;        -  To discover why doses were modified and how those modifications affected the survival          and health of the transplanted kidney; and        -  To determine whether, therefore, the side effects of MMF that result in dose alterations          are related to outcome.   "
180268|NCT00203684|"     Asthmatics have inflammation in the large airways (tubes through which air travels in and out     of the lungs). The large airways are located in the central lung. New research shows that     asthmatics also have inflammation in the small airways. The small airways are located in the     peripheral lung (the parts of the lung away from the central lung).      Until now, most of the inhaled medications available have been made up of big particles that     never reach the peripheral lung. The purpose of this study is to try to measure the level of     inflammation in the peripheral lung in asthmatics and see if this inflammation can be     decreased with different types of inhaled corticosteroids. The investigators will check     airway inflammation before and after use of an inhaled corticosteroid that has a large     particle size and should only reach the large airways (Flunisolide-CFC), and before and after     use of an inhaled, small particle corticosteroid that should reach both the large and small     airways (Flunisolide-HFA).      Subjects will make 6 study visits over two phases of the study. In the first phase, the     investigators will collect baseline information about subjects while they are using placebo     (inactive substance). In the second phase, subjects will take either the large or small     particle corticosteroid.      Visits will involve questionnaires and various tests measuring lung function (such as     spirometry, forced oscillation, and methacholine challenge). Exhaled nitric oxide will be     measured as an indication of inflammation. Subjects will also measure and make note of lung     function at home twice daily using a peak expiratory flow meter. Two of the visits will     involve fiberoptic bronchoscopy so that the investigators may collect cells and tissue     samples without surgery. Another two of the visits will involve the use of high resolution     computed tomography (HRCT) scans to indirectly evaluate disease in distant parts of the     lungs.   "
180269|NCT00203697|"     Pulmonary fibrosis is essentially scarring in the lungs. Some types (DIP, NSIP) most often     respond to therapy. Others like UIP (usual interstitial pneumonitis) rarely respond. UIP     frequently progresses and has a poor prognosis with a survival of three to five years. In     UIP, most often the cause cannot be determined and is therefore called Idiopathic Pulmonary     Fibrosis (IPF). A prevalence rate of 27–29 cases/100,000 has been reported that may even be     as high as 250 cases/100,000 in individuals 75 years of age.      Idiopathic pulmonary fibrosis (IPF) is a chronic and fatal pulmonary disorder. Conventional     treatment with immunosuppressive therapy has been disappointing, with a median survival of     <40% at five years after diagnosis. Moreover, this therapy may lead to premature deaths that     are a result of immunosuppression and susceptibility to infectious disease. Another problem     related to IPF, is that we have an incomplete picture of the natural history of the     pathogenesis of this disorder. Clearly, new strategies for therapy are necessary.      Published evidence suggests that less than 20% of patients with IPF respond to     corticosteroids (prednisone). In patients that fail steroids, immunosuppressant drugs such as     azathioprine or cyclophosphamide are used. An international consensus statement recommends     both steroids and azathioprine or cyclophosphamide from the onset of treatment. Unfortunately     a large number of trials have shown little or no effect of these drugs on the progression of     disease. There are currently no FDA approved drugs for the treatment of IPF.      Laboratory findings establish that human specimens of Interstitial Lung Diseases including     IPF demonstrate an impalance in expression of proteins (Th2 Cytokines, CC Chemokines, and CXC     Chemokines). When these protein levels are in excess or low, they alter the normal lung     mechanism, causing angiogenesis (abnormal blood vessel formation), inflammation, scar tissue     formation and impaired immunity of the patient. We hope to establish that the efficacy of     anti-angiogenetic agent as an add on therapy for IPF patients, will prove to bring     stabilization or improvement.      Minocycline has been shown to inhibit angiogenesis (new abnormal blood vessel formation) and     thus affect the fibrotic process (prevent scar tissue formation). Laboratory and animal     studies support a potential therapeutic role for Minocycline in IPF.      Minocycline is a semi synthetic derivative of tetracycline. It was first marketed as an     antibiotic in 1972. Clinical trials of minocycline have mainly been performed in sexually     transmissible diseases and in acne. Minocycline is also used to treat several other diseases     such as nocardiasis, mycobacteriosis, leprosy, lyme disease, pyoderma gangrenosum, autoimmune     bullous dermatitis, carteaud disease, and prurigo. The usual side effects of minocycline are:     lightheadedness, dizziness, or vertigo and pigmentation.      We will investigate genetic, molecular, cellular, whole animal models, and human specimens     from patients with fibrotic lung disease to test our prediction: The pathogenesis of     pulmonary fibrosis (lung scarring) is due to “multiple hits” that causes an inbalance of     certain mediators (proteins) that are responsible for abnormal blood vessel formation, scar     tissue formation (with and without inflammation inside the lungs) and impaired immunity of     the patient. Each of the 3 projects in this proposal have a direct link to other projects and     clinical core. The SCOR clinical core will identify and enroll patients with Interstitial     Lung diseases (ILD), including IPF. The clinical core will collect clinical data, as well as     obtain fluids from lung washings and human lung tissue specimens. Each project will use human     specimens as indicated in each of their specific aims to correlate their findings with     response to therapy.   "
180270|NCT00203710|"     The primary purpose is to study the safety and effectiveness of the Concentric Retriever     Device(CRD)in ischemic stroke patients who undergo clot retrieval with the CRD within 8 hours     of stroke symptom onset. The CRD has been approved by the U.S. Food and Drug Administration     to retrieve foreign bodies (such as pieces of metal) from blood vessels in the body. The CRD     is a small metal wire with a loop at the end (like a corkscrew) that removes clots from     arteries and thereby restores blood flow to the brain. Prior versions of the CRD may have     been too soft to pull out clots, just as a corkscrew that is too soft would not pull out     corks. The current version of the CRD is not as soft and may be more effective in retrieving     clots. Hypothesis: By restoring blood flow to the brain, stroke symptoms may get better or     the stroke may be prevented from getting worse.   "
180271|NCT00203723|"     The purpose of this study is to determine if the combination of risperidone and ECT improves     a patient's response in depression compared to ECT alone.   "
180272|NCT00203736|"     The purpose of this study is to compare the efficacy of sulfadoxine-pyrimethamine plus     artesunate with that of sulfadoxine-pyrimethamine on its own for the treatment of     uncomplicated malaria.   "
180273|NCT00203749|"     This study will evaluate the effectiveness of a combination of clinic- and community-based     voluntary counseling and testing programs in preventing HIV in African and Thai communities.   "
180274|NCT00203762|"     A scale-up of public sector antiretroviral treatment (ART) programmes may divert scarce     resources from other priority primary care programmes like tuberculosis and childhood     immunization.      The purpose of this study is to compare the performance of tuberculosis (TB) and childhood     immunization programmes in primary care facilities participating in the South African     national antiretroviral treatment programme with those which have yet to be included in the     ART programme.   "
180275|NCT00203775|"     This study examines the efficacy of haldol versus risperdal in the treatment of aggression in     psychotic prison inmates. It is hypothsized that risperdal will be more effective in     decreasing aggression than haldol.   "
180276|NCT00203788|"     This study will determine the effectiveness of combining antipsychotic medication with     Individual Placement and Support (IPS) and group training with the Workplace Fundamentals     Module or Brokered Vocational Rehabilitation in facilitating the search for appropriate work     or schooling and maintaining work or school activities in people with recent-onset     schizophrenia.   "
180277|NCT00203801|"     The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own     and compare this with efficacy of a new combination antimalarial therapy, either     sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.   "
180281|NCT00203853|"     It is known successful HIV therapy depends on the patients' ability to take their medicine     regularly. This study is designed to find out if an intervention designed to help patients     remember to take their medication is effective. The intervention consists of a wristwatch     that has an alarm to remind patients when to take their medication, a pillbox and three     monthly phone calls by a physician. All these experimental measures are meant to improve the     ability of patients to take their medicines.   "
180282|NCT00203866|"     The purpose of this study is to determine whether the experimental vaccine G250 with or     without IL-2 can produce an immune response in patients with renal cell carcinoma who have     had all their cancer removed by surgery.   "
180283|NCT00203879|"     Purpose of investigation: Primary hypotheses: Immunization of patients with 4 melanoma     antigen peptides will induce augmented specific IFN-y-producing CD8+ T cells against all 4     antigens simultaneously. Immunization with 4 melanoma antigen peptides will increase the     response rate from 10% to 30%. Administration of low-dose IL-2 following each vaccine will     result in a greater than 3-fold increase in specific T cells compared to no IL-2.      Secondary hypotheses: Immunization will clear the blood of detectable circulating melanoma     cells. Tumors that grow despite induction of melanoma antigen-specific T cells may lack     expression of antigens, class I MHC, or the TAP peptide transporter, or may fail to show     increased expression of mRNA for IFN-y or perforin. Tumors that resist vaccination may     express a different array of genes than those that are susceptible to vaccination.   "
180284|NCT00203892|"     The purpose of this study is to determine whether the experimental vaccine modified CEA     peptide CAP 1 -6D (mCEA) can produce an immune response in patients with pancreatic cancer     who have received chemotherapy and radiation therapy.   "
180285|NCT00203905|"     The primary objective of the study is to evaluate time to progression in eligible patients     with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus     when treated with the concomitant chemoradiotherapy regimen of bevacizumab/5-fluorouracil     (5-FU)/hydroxyurea/radiation therapy (B-FHX) in comparison to 5-fluorouracil hydroxyurea     (FHX) alone.   "
180286|NCT00203918|"     The purpose of this study is to help doctors and patients make better decisions about     prostate cancer treatment. This research is being done because we do not know how patient     preferences for health states related to prostate cancer affect the final treatment decision.   "
180287|NCT00203931|"     The purpose of the study is to determine in patients with Non Small Cell Lung Cancer     refractory to previous chemotherapy whether concomitant treatment with cetuximab and     pemetrexed improves progression-free survival compared with cetuximab monotherapy.   "
180288|NCT00203944|"     This study aims to provide information about the emotional and physiological responses of     post-institutionalized children in both a stressful situation (immunization) and a play     situation.   "
180289|NCT00203957|"     The purpose of this study is to confirm the long term tolerability and safety of oral 20 or     40 mg/d doses of Istradefylline.   "
180290|NCT00203970|"     The purpose of this research is to gain insight into the way in which physicians adopt new     practice techniques. In particular, we are interested in how medical innovations diffuse     throughout social networks. We wish to examine the diffusion of Low Molecular Weight Heparin     (LMWH) use for Deep Vein Thrombosis (DVT) throughout the social network of general internal     medicine interns, residents, and attendings at the University of Chicago Hospital. In     numerous clinical trials, LMWH has been demonstrated to be as effective as unfractionated     heparin as a bridge to long-term anticoagulation therapy with Coumadin, with the added     benefit of early discharge from the hospital with easy dosing, no need for monitoring, and     home therapy. A DVT critical pathway was established at the U of C in 1998, and LMWH was used     off-label for that purpose beginning in 1997. However, it is unclear how quickly the use of     LMWH was adopted by the physicians on the general medicine services, or whether there exists     a pattern for this adoption.   "
180291|NCT00203996|"     Polycystic ovary syndrome (PCOS) affects 5-10% of women in the United States. Its onset is     usually at the time of puberty with manifestations of menstrual irregularity, hirsutism, and     obesity. Women with PCOS suffer at an early stage of adulthood from all of the components of     the metabolic syndrome, a syndrome that typically has its peak in mid-life in other subject     populations. Women with PCOS are more insulin resistant than weight-matched control women and     have exceptionally high rates of early-onset impaired glucose tolerance and type 2 diabetes,     as well as a substantially elevated risk for hypertension, dyslipidemia, coronary, and other     vascular diseases. While recent evidence indicates that the prevalence of sleep-disordered     breathing (SDB) is 30-40 fold higher in PCOS than in weight-matched control women, the     possible role of SDB in causing the increased metabolic and cardiovascular risks of PCOS has     not been evaluated. The overall objective of the proposed study is to analyze the direction     of causality between sleep disturbances and markers of the metabolic syndrome in PCOS.   "
180292|NCT00204009|"     The goal of this study is to investigate the epidemiology and natural history of     childhood-onset diabetes, whether of autoimmune, non-autoimmune, or mixed etiology in     affected probands and their relatives.   "
180294|NCT00204035|"     The conceptual framework underlying the TEACH Research Program is based on a specific     theoretical approach designed to influence adolescent career choice, in this case towards a     career in clinical research. The factors responsible for influencing career choice that form     the foundation for our investigation are: 1) the importance of role models in career choice;     2) acquisition of knowledge in order to align ambitions; and 3) the participation of students     in activities that actively challenge and engage them. These three factors are addressed by     the following three components of the TEACH Research Intervention: 1) participation in a     research team consisting of a multi-tiered structure of mentors; 2) classroom instruction of     clinical research knowledge and career strategies; and 3) a hands-on clinical research     experience through an internship on the Hospitalist Project.      The evaluation of TEACH Research (Teaching Early Achievers for Careers in Health) aims to     rigorously evaluate a precollege enrichment program in clinical research targeting high     school students particularly underrepresented minorities, in order to increase the entry and     success of these students into careers in clinical research. Through these measures, the     TEACH Research Program will educate high achieving minority students and in turn hopefully     encourage and promote these students to think about a career in clinical research.   "
180295|NCT00204048|"     Care of hospitalized patients by hospitalists -- often defined as physicians who dedicate     at least 25% of their practice to inpatient care -- is a recent, growing, and controversial     trend in health care delivery in the United States. But despite the growth of interest in     hospitalists, there have been few scientific evaluations of the concept. The comprehensive     aim of this research study is to measure and analyze the effects of hospitalists on patient     outcomes, costs and medical education on the general medical services of a group of academic     centers.   "
180296|NCT00204061|"     The study will provide an empirical basis for a pharmacological treatment option. An     open-label, randomized, multi-centre parallel group design is used. An intensified clinical     management (CM), which allows needs-based psychological crisis intervention, is compared to a     combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is     that the combination of a clinical management with an atypical neuroleptic is the superior     treatment.   "
180297|NCT00204074|"     The purpose of this study is to determine whether transdermally administered 17-beta     estradiol sequentially could reduce the number of, and severity of, menstrual migraine     attacks.   "
180298|NCT00204087|"     The purpose of this randomized controlled trial is to develop a cognitive behavioral therapy     (CBT) for persons with at risk mental states in the early initial prodromal state and to     evaluate CBT in comparison to supportive counselling (SC).It is hypothesized that CBT is more     effective than SC on transition to subthreshold psychosis, psychosis and schizophrenia as     well as on prodromal symptoms and social adjustment.   "
180299|NCT00204100|"     Surface electrical stimulation has for many years been widely used to retrain paralysed     muscle and achieve the functions of standing and stepping. Recently a number of centres have     used electrical stimulation of the leg muscles to achieve cycling. During cycling the     quadriceps and hamstring muscles (thigh muscles) (and sometimes also the gluteal (buttocks)     muscles) are stimulated to obtain a cycling motion. Stimulation is applied using adhesive     electrodes placed on the surface of the skin. This form of exercise is known as FES-cycling     (FES = Functional Electrical Stimulation).      We have recently carried out a pilot study which investigated the feasibility of lower-limb     cycling using electrical stimulation. Cycling is accomplished using a standard recumbent     tricycle, which is adapted for the purpose of FES cycling. Three people with a complete     spinal cord lesion at level T7-T10 took part in the pilot study. The subjects are now able to     cycle continuously and reliably on a tricycle mounted on a cycle trainer for periods of up to     1 hour. The subjects are also able to cycle outside for distances of up to 3 km.      The purpose of the new study is threefold: (i) We wish to develop the equipment and methods     for recreational cycling to the stage of a pre-commercial design specification; (ii) The     subjects recruited for the project will carry out a progressive, high-intensity     cycle-training programme. In Glasgow, 5 paraplegic subjects shall complete the training     programme, which will be based at their homes. This will allow us to fully assess the     feasibility of recreational FES-cycling, by measuring the power which can be sustained during     long periods of cycling, and to measure the impact of the training regime on their quality of     life; (iii) We will determine whether the training regime leads to significant improvements     in cardiopulmonary fitness, and therefore lower risk of heart disease, and to reductions in     the likelihood of the development of pressure sores and fractures.      We hope that this type of exercise will lead to general improvements in the fitness of people     who might use the system in future.   "
180300|NCT00204113|"     The study will investigate the feasibility of using functional electrical stimulation (FES)     of the calf muscles of paraplegic subjects to assist in posture stabilisation during     standing. We aim to achieve postural stability by combining controlled FES of the lower-limb     muscles with the voluntary motor control skills of the intact upper body.   "
180301|NCT00204126|"     Treadmill therapy has the potential to improve the physical fitness and voluntary function of     incomplete-lesion spinal cord injured (SCI) patients. However, if it is to be offered as a     rehabilitation strategy, evidence must be gathered to support its effectiveness. Present     methods used to determine the efficacy of treadmill training do not provide accurate means of     monitoring changes in physical fitness during the exercise, or to accurately measure the     changes in voluntary muscle function which may occur during a training intervention.      We are therefore currently recruiting subjects for a study investigating the feasibility of     new methods for monitoring improvements in physical fitness during walking on a treadmill. We     also aim to develop methods for monitoring changes in voluntary muscle strength. The bone     density of both legs will also be measured to determine if any improvement has occurred     following training.   "
180302|NCT00204139|"     It is debatable whether routine ultrasound scanning of pregnancies at about 20 weeks of     pregnancy has substantive benefits for mothers and babies. Few studies have addressed this     issue in poorly resourced settings. This trial will attempt to determine the benefits, if     any, of a policy of routine ultrasound scanning of normal pregnancies versus a policy of no     routine (only selective) scanning. This will be done by recruiting about 900 women in South     Africa, and randomly allocating about half to routine scanning and half to selective scanning     groups, and following up their pregnancies.   "
180303|NCT00204152|"     The purpose of this study is to test the clinical efficacy of two psychotherapies for early     onset chronic major depression, including Behavioral Activation (Jacobson et al., 2001), and     an integrated version of Behavioral Activation and Stress Innoculation Coping (BASIC) for     short-term (16 weeks) of individual psychotherapy for adults with chronic major depression.     The control condition is an individual workbook condition of Behavioral Activation. These     psychotherapies focus on behavior activation, stress reduction and coping strategies to     counter depressive symptoms.   "
180304|NCT00204165|"     The purpose of this study is to compare MRI enteroclysis with MRI of the small bowel with a     per oral 6%mannitol solution.Our hypothesis is that the peroral technique preform the same     way as MRI Enteroclysis.   "
180305|NCT00204178|"     Measurement of reactive oxygen species production and antioxidant system status before and     directly after reperfusion of the transplanted kidney and influence of oxidant stress on     kidney function in 2 and 6 weeks.   "
180306|NCT00204191|"     The purpose of this study is to evaluate and compare, in the single center setting, the     safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based     on tacrolimus and cyclosporine.   "
180307|NCT00204204|"     The pupose of the study is a prospective evaluation of external and internal factors/causes     of importance for the trauma and final outcome experienced by persons inside motor vehicles     in serious car accidents. We hypothesise that there is an association between the use and     function of safety features and the results for the patient and an association between     material damage and the severity of injury.   "
180319|NCT00204360|"     The purpose of this database is to collect information for clinical purposes on all children     being treated for seizure disorders.   "
180320|NCT00204373|"     The purpose of this study is to study the safety and efficacy of high dose Prevacid in the     long-term treatment of patients who secrete abnormally large amounts of gastric acid.   "
180308|NCT00204217|"     Airway control and ventilation is vital during cardiopulmonary resuscitation (CPR) in cardiac     arrest. Endotracheal intubation is the gold standard for airway control, but several studies     have shown high rates of unrecognized placements of the tube in the esophagus instead of in     the airway out-of-hospital. This is lethal. There are no failproof technique for recognising     such mistakes clinically in the cardiac arrest situation. Changes on the air volume in the     lungs with ventilation changes the impedance (resistance to alternating current) through the     thorax. This impedance is already measured routinely by the defibrillators used during CPR.     We propose that we can measure ventilation volumes and also discover failed intubations by     monitoring this impedance during CPR with the possibility of giving feedback on both to the     rescuers.   "
180309|NCT00204230|"     Prospective, randomised study: Effect of mycophenolatmofetil (MMF) and CNI withdrawal in     patients with histologically proven chronic allograft nephropathy Indication: change in     immunosuppressive treatment of chronic allograft nephropathy (CAN)after renal transplantation     Hypothesis: Antimetabolite MMF is able to stop progression of CAN and improve blood pressure/     metabolic parameters and structural vessel wall changes      Primary Target:effects of CNI withdrawal and MMF on renal function: stabilisation and/or     improvement Secondary Targets: Incidence of adverse events Evaluation of the calcineurin     inhibitor free MMF treatment effects on blood pressure, lipids, glucose metabolism and on     structural and functional vesselwallchanges Method:open prospective, randomized two-tailed,     monocentric study   "
180310|NCT00204243|"     The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants     as a relapse prevention for opiate addicted inmates about to be released from prison. The     experimental group is compared with a control group that commences methadone maintenance     treatment before release.      The hypothesises are that quality of life and criminal behaviour improve significantly in     both groups compared to the month before incarceration. The experimental group is going to     have significant less days with opioid use compared to the MMT group.      We hypothesize furthermore that the implants can prevent death related to opiate overdose up     to 6 months after commenced treatment.   "
180311|NCT00204256|"     The objective of this study is the evaluation of the efficacy and safety of intravenous iron     sucrose in anemic patients with chronic kidney disease not on renal replacement therapy.   "
180312|NCT00204269|"     The objective of the study is to examine the efficacy and tolerability of a     three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's     compliance. The replacement therapy will be performed with a new Testosterone Gel examined in     previous trials as Testosteron Gel Wolff.   "
180313|NCT00204282|"     The purpose of the study is to evaluate the feasibility and efficacy of group visits led by     nurse practitioners in improving diabetic preventive services and vascular risk. Diabetes is     notable for its high burden on the health of urban populations, a rich literature supporting     evidenced based care, and great opportunities to apply systemic primary care interventions to     reduce its toll. Extensive literature demonstrates sub-optimal care in the community as well     as in academic centers. Addressing the needs of patients with diabetes is challenging in the     primary-care environment and nurse case management and disease-specific group visits which     focus on education and self-management skills have been shown to be useful adjuncts to     traditional outpatient care.      The study will attempt to demonstrate that nurse practitioner run group visits, during which     the NP will provide didactic education, facilitate group interaction, and arrange referrals     and laboratory testing as appropriate, will improve compliance with established American     Diabetes Association guidelines for screening and preventive care and in doing so lower     cardiovascular risk. Satisfaction with care, quality of life, and diabetic knowledge will be     assessed before and after the patients complete the program. In addition, we will attempt to     characterize barriers to care for patients who were formerly established with a primary care     physician in the Primary Care Group, but who have not received diabetic care there for at     least one year.   "
180314|NCT00204295|"     The purpose of this study is to determine the uptake of the amino acid     O-(2-[F-18]Fluorethyl)-L-tyrosin (FET) in human brain tumors using positron emission     tomography. A comparison to MRI and histopathological samples is used.   "
180315|NCT00204308|"     The purpose of this study is to determine whether the addition of tenofovir (TDF) and     emtricitabine (FTC)to a standard PMTCT regimen containing single-dose nevirapine (NVP) can     reduce the development of post-ingestion HIV resistance to non-nucleoside reverse     transcriptase inhibitors (NNRTIs).   "
180316|NCT00204321|"     Chronic transplant nephropathy and cardiovascular death are the main reasons for loss of     transplanted organs after kidney transplantation.      Vascular changes, induced by hypertension and/or immunological processes, determine long time     transplant survival.      It will be tested whether the withdrawal of calcineurininhibitors will improve the vessel     wall function in renal transplant patients. It is supposed that this immunosuppressive     regimen reduces the activation of endothelial cells with important impact on arteriosclerosis     and therefore on patient and transplant survival.   "
180350|NCT00185588|"     The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine     in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable     pancreatic cancer. The Phase II part of this study planned to determine the antitumor     activity of this regimen and its effectiveness of preventing tumor growth and spread.   "
180317|NCT00204334|"     Correction of anaemia in renal transplant recipients by parenteral application of recombinant     erythropoietin and if necessary iron will improve large artery function (endothelial function     and elasticity), as assessed by ultrasound techniques and applanation tonometry.      The changes in large artery function will be reflected by changes in serological markers of     endothelial function and oxidative stress and by changes in monocyte function and apoptosis.      There are gender differences in the responses of vascular function to correction of anemia.      Besides improvement of large artery function, correction of anemia will also affect     parameters of graft function, i.e. glomerular and tubular proteinuria.   "
180318|NCT00204347|"     The objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral     dimensions of Berderline Personality Disorder (BPD)in an open label trial:mood swings,     impulsivity, thing difficulties and disturbed relationships. The secondary objective of this     study (Study B)is to validate a self-report measure of clinical symptoms specific to the     treatment of patients with BPD, the UAB Borderline Rating Scale(BRS).   "
180323|NCT00204412|"     The purpose of our study is to use a flaxseed-based nutritional supplement in combination     with exercise training (walking) for improving cholesterol levels. We hypothesize that     exercise training will improve cholesterol profile and that adding supplementation with a     flaxseed nutritional supplement will further improve cholesterol profile.   "
180324|NCT00204425|"     The purpose of the study is to determine the effectiveness of combining exercise training     (i.e. weight lifting and walking) and dietary supplementation with a soy-based nutritional     supplement for increasing bone mineral density. We hypothesize that the exercise training and     soy-based supplement will be additive for increasing bone mineral density.   "
180325|NCT00204438|"     We hypothesize that administration of OCs at varying follicular diameters will provide an     appropriate model for the study of follicular atresia in women. Clinically, we hypothesize     that the administration on OCs at different stages of the follicular phase will result in     markedly different patterns of follicular development and/or atresia.   "
180326|NCT00204451|"     The researchers hypothesize that emergency contraception (EC) will initiate the changes     associated with atresia or ovulatory failure at all stages of follicular development and that     the image attributes associated with atresia will be similar regardless of the diameter of     the dominant follicle when ovarian suppression is initiated. Second, changes associated with     atresia may be observed, but ovulation of the dominant follicle is unimpeded.   "
180327|NCT00204464|"     Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron disease MND) among     adults. Motor neurons in the spinal cord, brain stem, and cerebral motor cortex degenerate     and create a variety of upper (UMN) and lower motor neuron (LMN) clinical signs and symptoms,     with the most frequently presenting symptom being focal weakness beginning in the leg, arm,     or bulbar muscles, occurring in more than 70% of patients. Despite the high incidence of     muscle weakness in patients with ALS, only two case studies evaluating the effects of     specific muscle strengthening and endurance exercise programs in this patient population have     been published, and the effects of resistive exercise programs in patients with ALS have not     been well studied. Some have discouraged exercise programs in patients with ALS because of     fear of overuse weakness. Yet, in patients with other neuromuscular diseases, resistive     exercise programs have been shown to be beneficial and have not produced overuse weakness.     The purpose of this study is to determine the effects of six months strengthening program on     strength, function, fatigue and quality of life in individuals with ALS.   "
180328|NCT00204477|"     Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian     hormones and breast density are considered breast cancer risk markers. We propose to test the     hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a     corresponding reduction in breast density.   "
180329|NCT00204490|"     Soy consumption has been associated with reduced risk for developing breast cancer. Soy     contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing     breast cancer risk are currently unclear. Breast density has been considered as a breast     cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities,     breast density and possibly bone density will be lower in women on soy-isoflavones.   "
180330|NCT00204503|"     The purpose of this study is to determine if Divalproex Sodium can be used to Treat and     Prevent Depression in Patients with Bipolar Disorder who have Comorbid Alcohol     Dependence/Abuse.   "
180331|NCT00204516|"     The purpose of the vaccination protocol is to induce specific immune responses against     melanoma associated antigens by intradermal injections of mRNA coding for the corresponding     antigen.   "
180332|NCT00204529|"     The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with     pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant     melanoma in stage IIA (T3a) - IIIB.      A total of 880 will be randomized up to three months after first surgical management of their     melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.   "
180333|NCT00204542|"     Topical treatment of mild to moderate actinic keratosis located on the face and head with     Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an     expansion of the treatment period to 6 months will increase the rate of complete responses.      Therefore the investigators will evaluate the efficacy and safety of the treatment of actinic     keratosis with Solaraze® applied twice daily to the face and head over 3 or 6 months of     treatment.   "
180384|NCT00186069|"     To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.   "
180334|NCT00204555|"     Results from a pilot study demonstrated that topical imiquimod could clear superficial and     nodular BCCs. Three phase II dose response studies in subjects with nodular BCC (nBCC) showed     that the histological cure rates with imiquimod depend on the doses applied per week and the     duration of treatment. Daily dosing or 5 times per week applications showed higher total     clearance rates than 3 times per week dosing or less frequent dosing. Furthermore, a 12 week     treatment period resulted in better efficacy results than a duration of only 6 weeks. On the     other hand, local skin reactions increased with the doses applied per week. So a prolonged     treatment period of 8 or 12 weeks with an application frequence of 3 times a week seems to be     a good compromise between efficacy and safety.   "
180335|NCT00204568|"     The goal of this trial is to determine whether oral continuous (metronomic) therapy with     trofosfamide results in a similar rate of progression-free time after 6 months as intravenous     treatment with adriamycin. In addition, the study is intended to investigate the level of     toxicity associated with the two treatment regimens (safety profile).   "
180336|NCT00204581|"     The intra-/perilesional application of interleukin-2 seems to be a safe and effective     treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of     intransit metastases the overall survival rate is still 20-30%.      However, the management of intransit metastases is sometimes difficult because of frequent     recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies     indicate. In this study the safety and efficacy of IL-2 are evaluated.   "
180337|NCT00204594|"     Phase I/II clinical trial to analyze safety and efficiency of intralesional application of     the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic     melanoma stage III/IV and unresectable metastasis.   "
180338|NCT00204607|"     vaccination protocol to induce specific immune responses against melanoma associated antigens     by intradermal injections of mRNA coding for the corresponding antigen   "
180339|NCT00204620|"     The aims of this trial are to evaluate the efficacy of bendamustin in patients with     metastatic soft tissue sarcoma who have progressed after or during an anthracycline-baesd     chemotherapy and to assess the treatment of toxicity.   "
180340|NCT00204633|"     The aim is to determine the frequency of RBC transfusion in patients with metastatic poor     prognosis germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without     Darbepoetin alfa   "
180341|NCT00204646|"     Complete resection is still the only curative treatment option in patients with soft tissue     sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without     evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant     dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with     non-resectable STS.   "
180342|NCT00204659|"     The optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet     been defined. In most circumstances, a stomach-conserving approach is favored, but the role     of radiotherapy is still a matter of debate. Recently, Rituximab along with full-dose CHOP     chemotherapy has been shown to improve the outcome in elderly patients with nodal DLBCL.     However, no data are available with such a therapy in patients with PG-DLBCL. Therefore, in     March 2003, we initiated an ongoing, prospective, multicenter phase II study in patients with     PG-DLBCL with 6 to 8 cycles of Rituximab (R; 375 mg/m2) plus CHOP-21 in order to evaluate the     safety and efficacy of this approach.   "
180343|NCT00204672|"     HYPOTHESIS      Gastroesophageal reflux is a major contributor to exercise-triggered asthma.      Two groups of patients will be studied: those with asthma who have difficulty with exertion,     those without asthma who experience difficulty with exertion. Both groups will experience     gastroesophageal reflux (GER) twice of less per week. Patients will complete a treadmill exam     to determine their VO2 max. They will then undergo pH monitoring while exercising for 30     minutes at 65-70% of their VO2 max. Subjects will be given placebo or acid suppression pill     for 12 weeks. At the end of 12 weeks, the subjects will repeat the exercise (30 minutes) and     24-hour pH study.   "
180344|NCT00204685|"     The purpose of this study is to determine whether Inhalation of Recombinant Human     Deoxyribonuclease Shortens Ventilation Time in Mechanically Ventilated Adults   "
180345|NCT00204698|"     This study proposes to investigate prospectively, the presence of molecular markers for     inflammation in laryngopharyngeal reflux (LPR) patients and to study the effect of a proton     pump inhibitor (Aciphex) on these molecular markers.      The investigators will be evaluating a group of patients before and after treatment. This     group will be patients that have untreated laryngopharyngeal reflux diagnosed by     laryngoscopic assessment and a 24-hour probe.   "
180346|NCT00185536|"     To test whether young children’s actual taste preferences are influenced by the natural     marketing environment in which they live. To do so, we tested whether preschool children     would like the taste of a food more if they thought it was from a heavily marketed source. We     asked preschool children to taste identical foods in packaging from this heavily marketed     source and plain packaging, and to tell us if they tasted the same or if one tasted better.     We hypothesized that, even among a sample of 3-5 year olds participating in Head Start, a     federally-sponsored preschool program for low-income families, young children would prefer     the taste of foods perceived to be from the heavily marketed source.   "
180347|NCT00185549|"     The purpose of this study is to evaluate the impact of an internet based program for children     and families (CF.DOC) with Cystic Fibrosis on health outcomes. The program provides for     virtual visits, a personal health record, messaging with clinicians and several tools for     monitoring self-care behaviors. We anticipate that this intervention will provide for more     intensive monitoring and feedback of self-care behaviors and will lead to improved health     status and in particular nutritional status   "
180348|NCT00185562|"     A 12 week trial of Adalimumab in subjects with active erosive inflammatory OA who have ahd an     inadequate response to NSAID therapy   "
180349|NCT00185575|"     The purpose of this study is to test the hypothesis that duloxetine (Cymbalta), in doses of     60 or 120 mg/day, is an effective and tolerable treatment for adult outpatients suffering     from dysthymia. Dysthymia is chronic, mild depression characterized by feeling sad or low     more days than not for more than 2 years.   "
180385|NCT00186082|"     This study is undertaken to find out whether prophylactic antibiotics can decrease the     infection rate in third and fourth degree perineal tear repairs done in the immediate     postpartum period.   "
180351|NCT00185601|"     The purpose of this study is to determine of the effectiveness of an Internet based Diabetes     Self-Management workshop for people with type II diabetes. Half of the people who complete     the workshop will be invited to continue their education by participating in a email     discussion group. Thus, we will be able to learn both the efficacy of the original program as     well as its efficacy when reinforced by the discussion group.      Diabetes is a disease that must be managed day by day by the individual with the disease.     Although we know a great deal about the self-management of type II diabetes, most     self-management is less than optimal. In addition, most people with diabetes do not have an     opportunity to participate in formal diabetes education. This study will determine if an     Internet delivered educational workshop will help people with diabetes manage their disease.     Thus we will be measuring changes in behaviors, changes in symptoms and changes in HbA1c,     blood pressure, cholesterol, and weight. If successful the workshop will serve as a prototype     for Internet diabetes education.   "
180352|NCT00185614|"     To determine toxicity and feasibility of mixed chimera allogeneic hematopoietic cell     transplants for multiple myeloma; prepare and vaccinate patients with allogenic dendritic     cell vaccinations following mixed chimera allogeneic hematopoietic cell transplants   "
180353|NCT00185640|"     To measure how frequently and to what degree a complication of transplant cell acute graft     versus host disease (GV/HD) occurs.   "
180354|NCT00185653|"     The purpose of the study is to determine the toxicity and feasibility of non-myeloablative     allogeneic hematopoietic cell transplants for multiple myeloma from unrelated donors.   "
180355|NCT00185666|"     The purpose of this study is to determine the usefulness of Cyberknife precision radiation in     eliminating or preventing the further growth of spinal tumors and lesions.   "
180356|NCT00185679|"     To assess the proportion of patients with donor neutrophil engraftment within 30 days of     allogeneic transplant. To assess the incidence of acute GvHD during the first 100 days after     transplantation.   "
180357|NCT00185692|"     The purpose of the study is to evaluate the feasibility and safety of transplanting CD34+     selected hematopoietic cells from a haploidentical related donor following a nonmyeloablative     regimen of total lymphoid irradiation (TLI) and antithymocyte globulin (ATG).   "
180358|NCT00185705|"     In this study, we propose using telmisartan, an angiotensin II receptor antagonist with     PPAR-gamma modulating activity, for a 12-week period to decrease blood pressure and insulin     levels in obese, hypertensive children. Telmisartan is currently approved for treatment of     adult hypertension. Recent adult studies, however, have shown telmisartan as an effective     medication for lowering insulin levels and improving insulin sensitivity. We will enroll 30     obese adolescents, ages 10 to 18 years, and randomly assign half of the group to receive     telmisartan and the other half to receive placebo (sugar-pill). We will obtain fasting     glucose and insulin levels, as well as other markers for insulin sensitivity and cholesterol     panel, at the beginning of the study, at each clinic visit in 4-week intervals, and at the     end of the study. We will obtain an imaging study (computed tomography, CT scan) on 10     randomly selected study patients (5 from each group) to examine the distribution of fat     tissue before and after treatment. Studies suggest that fat tissue in the subcutaneous tissue     is less harmful that fat tissues surrounding internal organs, such as the liver. We will also     provide nutritional handouts and exercise recommendations to each participant as a life-style     intervention. Each participant will be given a diary to record his or her diet and exercise     activities throughout the study.   "
180359|NCT00185718|"     To understand the impact of treatment induced menopause on quality of life and sexuality     following blood and marrow transplantation.   "
180360|NCT00185731|"     The purpose of this study is to:        1. Determine changes in levels of tumor bioactivity upon treatment with atorvastatin.           Secondary objective:        2. Determine validity of tumor bioactivity as a biologic endpoint by correlation with          clinical response.        3. Determine whether administration of atorvastatin is tolerable and safe in low grade NHL          patients. We do not anticipate any significant toxicity since this dose of atorvastatin          has been FDA approved for patients with hypercholesterolemia.   "
180361|NCT00185744|"     To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity     plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite     device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a     feasible and safe alternative to a six and a half week course of whole breast radiotherapy.     The study will measure both short and long-term complications of radiation treatment, short     and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional     recurrences, distant metastases, and overall survival.   "
180362|NCT00185757|"     The purpose of the study is to determine if the use of activated T cells can effectively     treat relapsed disease following allogeneic hematopoietic cell transplantation without     causing GVHD.   "
180363|NCT00185770|"     Randomized controlled trial to test the efficacy of reducing television, videotape and video     game use to prevent obesity, increase physical activity, improve physical fitness, and     decrease dietary fat and calorie intake among third grade children in twelve     ethnically-diverse elementary schools.   "
180364|NCT00185783|"     The purpose of this pilot study is to (1) examine the changes in gene expression in patients     who suffer from severe sepsis and whose shock (inadequate oxygen delivery to vital organs)     state does not respond to fluid and vasopressor administration, (2) to show that our sampling     method of isolating RNA provides reliable and consistent data, (3) provide a basis for future     gene expression studies in critically ill patients   "
180365|NCT00185796|"     To evaluate the feasibility and safety of TLI/ATG conditioning for allogeneic HCT for elderly     patients with advanced stage MDS and MPD.   "
180366|NCT00185809|"     The purpose of this study is to examine breast cancers that express the protein (NIS) that     may be found in malignant breast tissues and to evaluate proteins found in blood and their     relationship to NIS, to test whether iodide can be concentrated by breast cells to possibly     treat some breast cancers with radioactive iodine, and to calculate the amount of radioactive     iodine entering breast cancer cells, how long your cancer retains the agent as well as how     much is taken up by other organs, particularly the thyroid gland.   "
180386|NCT00186095|"     To evaluate the role of nonmyeloablative allogeneic transplantation in Amyloidosis.   "
180367|NCT00185835|"     To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839     in combination with cisplatin and radiation therapy in patients with local-regional recurrent     squamous cell cancer of the head and neck.      To study the effects of ZD1839 combined with either cisplatin or radiotherapy on signal     transduction pathway gene expression in tumor cells in patients with local-regional recurrent     squamous cell cancer of the head and neck using micro array analysis from tumor samples taken     at the time of relapse and during treatment.   "
180368|NCT00185848|"     The purpose of this study is to determine whether [18F]FHBG is suitable for use as an imaging     probe in cancer or rheumatoid arthritis patients enrolled in cell or gene therapy trials. In     this phase 1 study we will assess the safety and biodistribution of [18F]FHBG in patients.   "
180369|NCT00185861|"     To investigate the safety of delivering arsenic trioxide (ATO) in combination with     stereotactic radiotherapy in recurrent malignant glioma by performing an open label, Phase I     dose escalation trial. Results from this study will provide a basis for further study of ATO     combined with radiation therapy as a radiosensitizer for malignant brain tumors in future     Phase II studies.   "
180370|NCT00185874|"     Up to twenty-two patients will be enrolled in this study to receive autologous dendritic     cells (DCs) administered intratumorally into liver metastases following radiofrequency     thermal ablation of those lesions. Patients will receive two vaccinations of DCs at monthly     intervals. A dose escalation study of DCs will be included in this study in an attempt to     define the maximum tolerated dose of administered DCs.   "
180371|NCT00185887|"     To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation   "
180372|NCT00185900|"     To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm     labor   "
180373|NCT00185913|"     The purpose of the study is to identify a surrogate serum marker for tumor hypoxia in     patients with lung cancers.   "
180374|NCT00185939|"     This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in     the management of uncomplicated dog bites, utilizing currently best available antibiotics     (Augmentin) and an important clinical outcome of infection.      By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan     to utilize the point estimates of infection, side effects and other important outcomes and     incorporate these into a cost most to determine the most cost effective management of these     wounds and to determine if further study is warranted based on the findings.   "
180375|NCT00185952|"     Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor   "
180376|NCT00185965|"     Brief summary TBD   "
180377|NCT00185978|"     To develop and evaluate, in a randomized controlled trial, a comprehensive obesity prevention     program for third, fourth and fifth grade students.      The intervention includes activities in THE SCHOOL, THE HOME, and a clinically oriented     component for HIGH-RISK CHILDREN. In addition, the intervention will be delivered over a 3     year period, with age and grade-appropriate components for 3rd, 4th and 5th graders and their     families. The primary outcome is body mass index.      PRIMARY OBJECTIVE: To significantly reduce body mass index, compared to controls, at the end     of the three year intervention.   "
180378|NCT00185991|"     To compare once daily versus 8 hour dosing of gentamicin for the treatment of     chorioamnionitis.   "
180379|NCT00186004|"     We wish to find out if in non-diabetic pregnancies, as well as diabetic pregnancies,     additional data obtained by Continuous Glucose Monitoring improves perinatal risk prediction.   "
180380|NCT00186017|"     We will assess the effect of olanzapine compared to placebo added to prior treatment on CGI-S     in a one-week randomized double-blind study. We will also assess the effect of olanzapine     added to prior treatment on CGI-S in an eight-week open treatment study. In addition, we will     assess the effect of olanzapine on Young Mania Rating Scale (YMRS), Hamilton and     Montgomery-Asberg Depression Rating Scales (HDRS, and MADRS), and Hamilton Anxiety Rating     Scales (HARS) in the above paradigms. We will also assess the influence of presentation     severity (CGI-S) and polarity (mood elevation versus depression) on olanzapine response.     Finally, we will assess safety and tolerability of olanzapine in the above paradigms.      We hypothesize that in diverse mild syndromal and subsyndromal exacerbations of BD in     outpatients, randomized double-blind flexibly dosed olanzapine added to prior treatment     (including no treatment) will yield greater CGI-S improvement than placebo by the end of one     week, and that such improvement will persist over one week of open continuation treatment.   "
180381|NCT00186030|"     This two-year study tested the concept that an intervention, which reduces trauma-related     symptoms among adults who are living with human immunodeficiency virus (HIV), are     experiencing trauma-related stress symptoms, and engaging in behavior that facilitates HIV     transmission, can reduce the transmission risk of (HIV). Our central premise was that by     first treating trauma symptoms, we would enhance the effects of a skills-building HIV risk     reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal,     dissociation, and avoidance.      The study aims were to:        1. To determine if decreasing trauma-related stress symptoms improves HIV risk reduction          behavior above a standard HIV risk reduction intervention alone post-intervention and 3          months after the small group intervention sessions;        2. To determine whether key variables moderate the intervention’s effects. For instance,          gender, age, ethnicity, or psychological distress (e.g., depression, anxiety) may          interact with the intervention to affect risky sexual or drug-related behavior; and        3. To determine whether there is evidence that the theoretical mediator variables, which          include trauma-related stress symptoms, self-efficacy, communication skills, and social          support mediate the intervention’s effects on outcomes. This information addresses the          theoretical question of why the intervention works.   "
180382|NCT00186043|"     1. The primary objective of this study is to examine the efficacy of quetiapine (Seroquel)          in treatment of dysphoric hypomania in patients with Bipolar II disorder.        2. To evaluate the utility of Seroquel add-on treatment to decrease mixed depressive and          hypomanic symptoms.   "
180383|NCT00186056|"     The purpose of the study is to examine the effectiveness of mifepristone treatment in     patients with refractory depression. Refractory depression is defined as clinical depression     that is unimproved after treatment with at least 2 different antidepressants of adequate dose     and time trial. Mifepristone will augment current medications.   "
180387|NCT00186108|"     The primary purpose of this study is to evaluate the ability of oral triamcinalone given     twice a day to patients with androgen independent prostate cancer to produce a sustained     biochemical response. Secondary goals are to describe the safety and tolerability at this     dose and schedule, to determine the time to sustained biochemical response, to determine the     duration of biochemical response, to determine the time to disease progression.   "
180388|NCT00186121|"     To evaluate the antitumor activity, toxicity, and effectiveness of the combination of     Arimidex and Zoladex in the treatment of premenopausal women with hormone receptor positive     metastatic carcinoma of the breast.   "
180389|NCT00186134|"     The purpose of the proposed study is to determine the effect of walking to school for one     week on total physical activity and patterns of physical activity in third, fourth and fifth     grade students.   "
180390|NCT00186147|"     The purpose of this study is to obtain tissue samples for ongoing studies regarding     transplant outcomes and complications.   "
180391|NCT00186173|"     The purpose of this study is to learn whether overweight children who participate in an after     school sports program improve their health as much as overweight children in a more     traditional health education program.   "
180392|NCT00186186|"     The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar     depression and to evaluate metabolic and GABA changes with Depakote ER administration using     PET and MRI/MRS brain imaging techniques.   "
180393|NCT00186199|"     Determine if the pattern of voiding differs in children with vesicoureteral reflux (VUR)     compared to those who do not have VUR.   "
180394|NCT00186212|"     Evaluate the effects of a workbook/journal for helping isolated women to cope with breast     cancer.   "
180395|NCT00186225|"     To evaluate the use of unrelated donors for hematopoietic cell transplantation in the     treatment of hematologic and lymphoid malignancies.   "
180401|NCT00191659|"     To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine     hydrochloride in comparison to standard current therapies have greater improvements in their     quality of life.   "
180402|NCT00197041|"     Malaria is an important cause of death and serious illness among Mozambican children.     Although the risk of malaria can be reduced by drugs and by impregnated bed nets, it would be     helpful if children could be protected against malaria by a vaccine.      GSK Biologicals is developing in partnership with Malaria Vaccine Initiative at PATH a     candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children     living in malaria endemic areas. The vaccine would offer protection against malaria disease     due to the parasite Plasmodium falciparum and also would provide protection against infection     with hepatitis B virus. Previous studies have shown the candidate malaria vaccine RTS,S/AS02     to be safe when administered in adults and children aged 1-11 years. However, to assess if     this vaccine could provide protection against malaria in children, this study has been     undertaken.   "
180403|NCT00197054|"     The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30%     efficacy against clinical episodes of malaria and approximately 58% efficacy against severe     malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine     RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army     Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B     vaccine to the African adults to establish safety and immunogenicity in this population.     Preliminary indication of vaccine efficacy with this adjuvant will be established by     monitoring the time to the first infection with Plasmodium falciparum.   "
180404|NCT00197067|"     GSK Biologicals is developing in partnership with the Malaria Vaccine Initiative at PATH a     candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children     living in malaria endemic areas. The vaccine would offer protection against malaria disease     due to the parasite Plasmodium falciparum and also would provide protection against infection     with hepatitis B virus. Studies conducted using the formulation RTS,S/AS02A (0.25 ml dose) in     children and adults have shown to be safe. Currently all intramuscular vaccines in the EPI     schedule are administered at a dose volume of 0.5 ml and in this context, a new variant of     RTS,S/AS02D (0.5 ml dose) formulation has been composed which has the same active     constituents in the same quantities as in a 0.25 ml dose of RTS,S/AS02A. In this study,     RTS,S/AS02D (0.5 ml dose) was compared to the existing formulation, RTS,S/AS02A (0.25 ml     dose).   "
180405|NCT00197080|"     The purpose of this study is to assess the efficacy and safety of ropinirole XR in the     treatment of adults with Restless Legs Syndrome (RLS).   "
180406|NCT00197093|"     This study is a placebo-controlled study to assess the safety and tolerability of a novel     antipsychotic medication, (773812) when given to schizophrenic patients for twenty-eight     days. Assessments include blood sampling to determine drug concentrations, psychiatric     assessments while under treatment, and movement assessments to evaluate potential side     effects.   "
180407|NCT00197106|"     This study is being conducted to investigate whether in childhood salmeterol/ fluticasone     propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd     delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally     we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms     of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing     management of asthma in children.   "
180408|NCT00197119|"     To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface     antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first     dose of the study vaccine.   "
180409|NCT00197132|"     Fluid management study in patients with insulin resistance.   "
180410|NCT00197145|"     The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist     GW873140 or placebo in combination with an optimized background regimen in     treatment-experienced HIV-infected subjects with R5-tropic virus   "
180411|NCT00197158|"     GSK Biologicals' currently licensed multidose hepatitis B vaccine will be compared to the     currently licensed monodose hepatitis B vaccine in a population with well documented     hepatitis B immunological response to the vaccine (Belgium).   "
180412|NCT00197171|"     To evaluate the persistence of immune response 5 years and 6 years after the first vaccine     dose.   "
180413|NCT00197184|"     To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface     antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of     the study vaccine.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
180414|NCT00197197|"     The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist     GW873140 or placebo in combination with an optimized background regimen in     treatment-experienced HIV-infected subjects with R5/X4-tropic virus   "
180415|NCT00197210|"     The main objectives of this study are to determine vaccine efficacy against severe rotavirus     (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two     years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to     definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.   "
180416|NCT00197223|"     As a result of the recent supply shortages in the U.S., as well as an anticipated increase in     demand during the coming years, GSK Biologicals is pursuing licensure of Fluarix in the U.S.     under the accelerated approval process; marketing approval most likely will be granted before     the start of this clinical trial. GSK proposes to support U.S. licensure of Fluarix with this     confirmatory post-marketing study. The purpose of the study is to evaluate the efficacy of a     single dose of Fluarix in preventing influenza in adults during the 2005/2006 Influenza     season.   "
180417|NCT00197236|"     This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose     inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis     combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15     months of age. The Protocol Posting has been updated in order to comply with the FDA     Amendment Act, Sep 2007.   "
180612|NCT00209989|"     The purpose of this study is to determine the efficacy by the determination of the Time To     Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5     cm treated with the combination of ZARNESTRA plus Radiation therapy.   "
180418|NCT00197249|"     To evaluate the immunogenicity, reactogenicity and safety of Hepatyrix when compared to the     concomitant administration of Typherix and Havrix, and when compared to the administration of     monovalent vaccines, Havrix or Typhim Vi. Furthermore, the study will evaluate the     persistence of anti-Vi and anti-HAV antibodies up to 36 months after administration of the     first dose of the study vaccine.   "
180419|NCT00197262|"     Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following     allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of     allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly     referred to as (hay fever), it is characterized by sneezing, nasal congestion and pruritus,     rhinorrhea, and pruritic, watery, red eyes. The primary objective of this study is to compare     the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle     placebo nasal spray in adult and adolescent subjects (12 years of age and older) with     seasonal allergic rhinitis (SAR) caused by ragweed pollen.   "
180420|NCT00197275|"     The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3     production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and     meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB     (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single     injection.   "
180421|NCT00197288|"     The purpose of this study is to compare two licensed influenza vaccines (Fluzone and Fluarix)     in terms of the immune response elicited and the safety/ any symptoms that may occur for up     to six months after vaccination.   "
180422|NCT00197301|"     Influnza vaccination is highly recommended over the age of 50,but is only 50% efficatious     among the elderly. A Vaccine given as a nasal spray may improve compliance and local     immunity.Liposomes are lipid particles that may serve as carriers for the vaccine and     together they enhance the local immune response in mice when given as nasal spray.This study     aims to examine the safety and nasal and humoral responses to the nasal vaccine compared to     the commercial muscular vaccine.   "
180423|NCT00197314|"     This is a randomized controlled trial comparing two methods of exercise for the treatment of     stress incontinence ( loss of urine after physical exertion) in women. We are comparing the     Paula method of circular muscle exercise, in which circular muscles controlling sphincters of     the body (such as the eyes, mouth and rectum) are exercised, with pelvic floor training     (Kegel exercises) in women in the community. The study hypothesis is that the effectiveness     of circular muscle exercises is equivalent to pelvic floor training among women with this     disorder.   "
180424|NCT00197327|"     This study studies labor epidural analgesia and compares dilute (0.0625%) with concentrated     (0.25%) bupivacaine.      We hypothesize that patients randomize to receive the concentrated drug will require more     drug, will have a more profound motor block, will be more likely to require instrumental     delivery and will be less satisfied than those receiving dilute epidural drugs.   "
180425|NCT00197340|"     Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are common and important     disorders of pregnancy. Both disorders are associated with an impairment of uteroplacental     blood flow (UPBF). No effective therapy has been identified to reliably improve UPBF in these     patients and typically, obstetric management involves interventional delivery, particularly     problematic when remote from term. This study assess the hypothesis that epidural local     anesthetics may improve UPBF in these patients.   "
180426|NCT00197353|"     This study aims to compare human subjects receiving epidural bupivacaine local anesthetic at     different doses and concentrations and to assess the effect on vasodilatation     (sympathectomy), sensory and motor block.      The hypothesis is that the drug concentration is more important than drug dose in the     determination of the extent and intensity of differential sympathetic, sensory and motor     block following epidural local anesthetic.   "
180663|NCT00210652|"     The purpose of this study is to evaluate the safety and preliminary effectiveness of the     novel compound RWJ-333369 in patients with partial onset seizures who are currently being     treated with 1 or 2 concomitant antiepileptic drugs.   "
180427|NCT00197366|"     It has been shown that treatment of HIV-positive women with antiretroviral medication during     pregnancy reduces the risk of HIV transmission to the child. However, such treatment could     lead to the selection of resistant virus strains in the mother. The object of this study is     to check HIV+ pregnant women for resistance mutations in HIV before and after the     antiretroviral therapy they receive during pregnancy. HIV-positive newborns will also be     tested, to see if a resistant virus strain was transmitted from mother to child.   "
180428|NCT00197379|"     The purpose of this study is exploiting the new drugs for androgenetic alopecia because there     are still no effective and safe topical drug for androgenetic alopecia. Roxithomycin is one     of the macrolide antibiotics that has immunomodulatory effects. We firstly found that     roxithromycin increases the rate of murine and human hair follicle elongation in vitro.     Therefore, we apply this drug on this disease therapy.   "
180429|NCT00197392|"     The purpose of this non-significant risk study is to establish initial baseline infection     rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic     impregnated catheter) and to compare relative rates of ventriculostomy-related infection     between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized     open label study   "
180430|NCT00197405|"     Colorectal cancer (CRC) is the second common cause of death in the Western world, and is very     increasing in Japan. Fecal occult blood test (FOBT) is used routinely for CRC screening,     which has been shown to reduce the incidence, morbidity, and mortality of CRC. However, there     is a need to develop a novel method to improve sensitivity. The investigators reported that     Fecal COX-2 assay, one of fecal RNA test, is potentially useful for colorectal cancer     screening (Gastroenterology 127; 422-427, 2004). So the investigators planed to compare fecal     RNA test with FOBT for detecting colorectal cancer and adenoma.   "
180463|NCT00197912|"     The aim of the study is to show if vaccination with autologous dendritic cells pulsed with     peptides or tumor lysate in combination with adjuvant cytokines and Cyclophosphamide can     induce a measurable immune response in patients with metastatic malignant melanoma, and to     evaluate the clinical effect (objective response rate) of the vaccination regime.   "
180648|NCT00210457|"     To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel     given in doses titrated to effect in acromegalic patients previously treated or not with     somatostatin analogues.   "
180431|NCT00197418|"     Proton pump inhibitors (PPIs) are mainly metabolized in the liver by CYP2C19, one of the     cytochrome P450 isoenzymes, which shows a genetic polymorphism associated with enzyme     activities. The most essential role of a PPI in H. pylori eradication therapy is to make     antibiotics more stable and bioavailable in the stomach by raising intragastric pH to neutral     levels.      Most patients who have failed in the eradication of H. pylori infection by triple therapy     with a PPI, amoxicillin (AMPC) and clarithromycin (CAM) at standard doses have extensive     metabolizer (EM) genotypes of CYP2C19 and/or are infected with CAM-resistant strains of H.     pylori.      Four-times daily dosing of a PPI could achieve complete gastric acid inhibition. Dual therapy     with 4-times daily dosing of a PPI and AMPC could yield sufficient re-eradication rates in     patients with EM genotype of CYP2C19.      Metronidazole (MNZ)-based re-eradication therapy, such as triple PPI/AMPC/MNZ therapy, also     achieved high eradication rates and has been recommended as the second line therapy in Japan.     But carcinogenic actions of MNZ have been unclear.      The purpose of this study is to compare the re-eradication rates of H. pylori infection by     the dual high-dose PPI/AMPC therapy and triple PPI/AMPC/MNZ therapy, and to validate the     efficacies of these re-eradication regimens as second line eradication therapies.   "
180432|NCT00197431|"     S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug     of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits     dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces     gastrointestinal toxicity. 5-FU is metabolized by CYP2A6 and DPD. In this study, the     researchers investigate the influences of differences in activities of CYP2A6 and DPD on     pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer     patients treated with S-1.   "
180433|NCT00197444|"     The purpose of this study is to clarify efficacy and toxicity of daily low-dose Nedaplatin     (CDGP) and continuous infusion of 5-FU combined with radiation in patients with esophageal     squamous cell carcinoma.   "
180434|NCT00197457|"     Helicobacter pylori (H. pylori) eradication increases the serum pepsinogen (PG) I/PG II ratio     and the percentage change in PG I/PG II ratios was found to be a useful marker of H. pylori     eradication (e.g., the PG method). We studied whether the PG method could be an early     diagnostic marker of H. pylori eradication even in patients persistently treated with a     proton pump inhibitor. Sixty-two H. pylori-positive patients underwent H. pylori-eradication     therapy, followed by treatment with a PPI to cure ulcers. Serum levels of PG I and PG II were     measured before, at the end of, and at 4 weeks after the eradication therapy. At more than     one month after the end of treatments, 13C-urea breath test (UBT) was performed. The cut-off     values of percentage changes in PG I/PG II ratios for the diagnosis of eradication of H.     pylori were set in proportion to PG I/PG II ratios before eradication in accordance with our     previous report. Using the results of UBT as the standard, the percentage change in serum PG     I/PG II ratios is useful as an early diagnostic marker for judgment of H. pylori eradication     irrespective of PPI treatment.   "
180435|NCT00197470|"     Recently, cytokine polymorphisms are considered to play an important role in the pathogenesis     of peptic ulcer and gastric cancer. We intended to clarify the association between     polymorphisms of pro-inflammatory and anti-inflammatory cytokines, and the susceptibility to     gastric cancer, gastric ulcer and duodenal ulcer in Japan, and to detect the individuals who     have higher risks for gastrointestinal disease development.   "
180436|NCT00197483|"     Dopamine has been closely associated with prefrontal function. The hypothesis that a lower     dopaminergic activity is associated with negative symptoms and cognitive dysfunction observed     in the patients of schizophrenia is of a heuristic value in guiding research in this area.     This hypothesis led us to test whether pergolide, a D1/D2 agonist, could improve negative     symptoms and cognitive impairments prevailing in most patients with schizophrenia. This     double-blind placebo controlled study will investigate the remedial effect of pergolide on     negative symptoms and cognitive impairments in schizophrenia.   "
180457|NCT00197834|"     This prospective, naturalistic, open label study will test the hypothesis that Depakote is     correlated with a reduction in elevated Cohen-Mansfield Agitation Index (CMAI) verbal and     physical agitation and aggression scales over a 6-week period among patients with elevated     scores on those scales, and that these positive results can be achieved with fewer side     effects than with other agents. In addition, patients will be rated with respect to changes     in the Clinical Global Impression (CGI) at baseline, week 1, 3, and 6 and the     Neuropsychiatric Inventory (NPI) at baseline and week 6.   "
180437|NCT00197496|"     Achieving independent ambulation is an important goal of hip fracture rehabilitation, as it     is predictive of returning to the community and of future health problems. Current research     regarding post-hip fracture rehabilitation is sparse. Body weight supported treadmill     training (BWSTT) is a novel approach to retrain walking abilities. BWSTT may be ideal for     retraining walking after hip fracture, as it is task-specific and alleviates the demands of     maintaining balance while walking skills are trained. The use of the harness may provide a     sense of security for the patient, facilitating walking training. The proposed project will     investigate the feasibility and tolerability of BWSTT after hip fracture, and its impact on     function, mobility, quality of life and fear of falling. It is hypothesized that BWSTT 3-5     times weekly in acute hip fracture patients will improve function, mobility, quality of life     and reduce fear of falling.   "
180438|NCT00197509|"     The purpose of this study is to see if providing training using a Sit-to-Stand protocol for     residents of Long-Term Care Facilities who have had a stroke will increase their independence     in performing Sit-to-Stand.   "
180439|NCT00197522|"     We, the researchers at Hamilton Health Sciences, have developed a novel approach to cancer     therapy using transfected dendritic cells (DCs) to generate enhanced immunity to defined     tumor antigens. Dendritic cells are highly specialized antigen presenting cells found in the     bone marrow, lymph nodes, skin and thymus. Infection of DCs with Adenovirus (Ad) vectors     incorporating genes for defined tumor antigens enables intracellular expression and major     histocompatability complex (MHC)-restricted presentation of tumor peptides by transfected     DCs. Given the potent immunostimulatory properties of DCs and ability to use gene transfer to     load DCs with tumor antigen, we hypothesize that administration of transduced autologous     DCs may have potential therapeutic benefit as a cancer vaccine. We have examined Ad-tumor     antigen DC based vaccination in murine models of breast cancer and melanoma. In both models,     injection(s) of Ad-transduced DCs results in highly potent immune activation and     antigen-specific anti-tumor responses. In these models, high levels of antigen-specific,     cytotoxic effector lymphocytes that recognize and kill cancer cells directly correlates with     a therapeutic response (tumor regression and/or complete protection of animals subsequently     re-challenged with tumor cells). Animals demonstrating specific in vitro immunity are     protected against subsequent injection of cancer cells. Moreover, we have observed complete     resolution and significant long-term survival in animals with established metastatic disease     with no demonstrable toxicity. As opposed to vaccination protocols with tumor peptides or     purified epitopes that are MHC-I restricted (i.e. HLA-A2), we have found that injection of     DCs transduced with a vector expressing the entire tumor antigen results in peptide     presentation from both MHC-I and MHC-II complexes. The subsequent immune response is     comprised of both CD4+ and CD8+ T cell populations. Thus, Ad-based gene transfer of tumor     antigens appears to be an efficient approach: (1) enabling sustained endogenous peptide     processing, and (2) facilitating DC-specific presentation to the host immune system. We have     shown that using a replication deficient adenovirus vector expressing Her-2/neu DNA under the     control of a human mouse mammary tumor virus (MMTV) promoter that we can transfect bone     marrow derived DCs (AdHer2/DC). These cells are then used to immunize recipient mice against     tumour challenge with Her2 transgenic tumour cells. The protection is antigen specific (anti     Her2). On the basis of these pre-clinical studies we will initiate a pilot trial of the     AdHer2/DC vaccine in Her -2/neu overexpressing patients with metastatic breast cancer.     Long-term goals and implications of possible results: The goals of this initial pilot phase I     study are to evaluate the safety and dosing schedule of the vaccine therapy. The vaccine will     be tested in subsequent phase II and III studies to determine efficacy in comparison to     standard therapies. The long-term goals are to eventually test this therapy in the adjuvant     breast cancer setting in Her-2/neu overexpressing patients.   "
180440|NCT00197548|"     The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal     loss, low birth weight and severe preterm birth in healthy (HIV negative) women.   "
180441|NCT00197561|"     The purpose of this study is to determine whether the oral administration of daily selenium     supplements to HIV-1 positive pregnant women: enhances immune status and reduces the HIV-1     viral load at six months postpartum, reduces the risk of lower genital shedding of HIV-1     infected cells at 36 weeks of gestation, and reduces the risk of mastitis at six weeks     postpartum, compared to placebo.   "
180442|NCT00197587|"     The purpose of this study is to find the most effective and safe treatment to prevent the     passage of HIV from an infected mother to her baby.   "
180443|NCT00197613|"     The Adult Antiretroviral Treatment and Resistance Study, hereafter referred to as The     Tshepo Study, is the first large-scale research study of antiretroviral therapy to treat     AIDS and HIV infection in Botswana. The Tshepo Study is an open-label, randomized study     comparing: (1) the rate of development and specific types of drug resistance mutations with     various antiretroviral combination therapies to HIV-1C, the subtype of HIV found in southern     Africa, and (2) the short and long-term effectiveness of two operational modifications of     Directly Observed Therapy (DOT) medication adherence strategies for antiretroviral therapy.     Specifically, treatment follow-up via the Standard of Care, the national standard of care as     it evolves in Botswana, with intensive clinic-based follow up including regular adherence     education sessions, will be compared to Community-Based Directly Observed Therapy (Com-DOT).     Com-DOT involves the SOC with added community or family-based DOT. This Com-DOT component     would involve a trained, community or family-based Medication Partner (mopati) who observes     the patient take his or medications daily.   "
180444|NCT00197639|"     This study looks at the ways indinavir drug levels, when boosted with ritonavir, may vary     from patient to patient. The study population are HIV+ Thai individuals.   "
180445|NCT00197652|"     The goals of this study are to:        1. determine the diarrheal rates, morbidity, mortality, and pathogens present among          breast-fed infants born to HIV-infected mothers.             -  analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts               of infected mothers.             -  comparison to rates among infants born to HIV uninfected mothers.        2. link analysis of the functional quality of immunoglobulins in the breast milk of          HIV-infected and uninfected mothers.   "
180446|NCT00197678|"     The purpose of this study is to examine effects of daily administration of multivitamin     supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to     HIV positive women decreases the risks of low birth weight (<2500 g), and pre-term birth (<     37 weeks gestation), compared to multivitamin supplements at doses above the RDA.   "
180447|NCT00197691|"     The purpose of this study is to learn about lower respiratory tract and bloodstream diseases     among infants born to HIV positive mothers in Botswana. Study factors include how commonly     infants get these diseases, the causes, and outcomes. The study will also try to measure the     protective effect, if any, of breast feeding on respiratory disease illness and deaths.   "
180448|NCT00197704|"     The purpose of this study is to determine the efficacy of micronutrient supplementation among     patients with active tuberculosis, half of who are co-infected with HIV-1   "
180449|NCT00197730|"     The purpose of this study is to examine the effects of multivitamin (B, C, E) supplementation     on reducing the risk of morbidity and mortality outcomes among children born to HIV positive     mothers, compared to placebo supplementation.   "
180450|NCT00197743|"     This study tested the hypothesis that multivitamin supplementation given to HIV+ pregnant     women in Tanzania would slow disease progression and enhance their overall health.   "
180451|NCT00197756|"     The purpose of this study is to analyze stored samples and data collected during the conduct     of the study A Trial of Vitamins in HIV Progression and Transmission (HD32257). The aims     are to examine the effect of vitamin supplementation on HIV infected women during pregnancy     on a number of parameters in breastmilk.   "
180452|NCT00197769|"     The purpose of the trial is to determine the minimum of doses of a new nine valent     pneumococcal conjugate vaccine required to protect UK infants and toddlers   "
180453|NCT00197782|"     To measure the magnitude and persistence of the antibody response to a booster dose of Hib     conjugate vaccine given between 9 months and 4 years of age to UK children who had completed     primary immunisation with 3 doses of Hib vaccine given at 2/3/4 months of age either as a     combined D/T/wholecellpertussis/Hib or D/T/acellularpertussis/Hib vaccine.   "
180454|NCT00197795|"     To measure the serum bactericidal antibody levels and cell mediated immune responses before     and six weeks after each dose of meningococcal outer membrane vesicle vaccine given at 0,6     and 12 weeks to healthy UK adults.   "
180455|NCT00197808|"     The purpose of the study is to evaluate the immune responses of UK infants after one or two     doses of pneumococcal conjugate vaccine or one or two doses of three different types of     meningococcal conjugate vaccine given at either two and three or two and four months of age.   "
180456|NCT00197821|"     To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain     pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged     50-80 years, and subsequent antibody persistence and response to boosting.   "
180458|NCT00197847|"     Purpose of the study is to investigate and quantify known and possible new riskfactors for     nosocomiel infection and death in the intensive care setting.      As new riskfactors Mannose Binding Lechtin and Procalcitonin are chosen and compared to     established riskfactors.   "
180459|NCT00197860|"     The purpose of this study is to show if vaccination with autologous dendritic cells pulsed     with peptides or tumor lysate in combination with adjuvant cytokines can induce a measurable     immune response in patients with metastatic renal cell carcinoma, and to evaluate the     clinical effect (objective response rate) of the vaccination regime.   "
180460|NCT00197873|"     Chemotherapy may cause diarrhoea, which may be associated with treatment delay and     infections. The purpose of the study is to investigate whether oral supplementation with     lactobacilli will alleviate chemotherapy related diarrhoea. Patients diagnosed with advanced     colorectal cancer and who will receive chemotherapy will be randomly assigned to receive     either lactobacilli or placebo during chemotherapy. The study is a prospective, multicenter,     randomized, double-blind, placebo-controlled study. The primary outcome measure is frequency     of moderate/severe diarrhoea. The study will also address safety and tolerability of     chemotherapy, response to chemotherapy, and serum growth factor levels.   "
180461|NCT00197886|"     Norepinephrine is a drug used to increase blood pressure in patients with life-threatening     infection. However, norepinephrine may limit the bloodflow to the gut, thereby causing     relative lack of oxygen to the cells. This leads to increased formation of lactic acid.      This study examines whether increasing the dose of norepinephrine leads to higher     concentrations of lactic acid in the rectum and stomach in patients with life-threatening     infection.   "
180462|NCT00197899|"     The purpuse of this study is to examine the acute phase respons when different doses of E.     Coli Endotoxin is injected in healty volunters.   "
180464|NCT00197925|"     The study aim to show if vaccination with autologous dendritic cells pulsed with     onco-peptides in combination with adjuvant cytokine can induce a measurable immune response     in patients with metastatic breast cancer, and to evaluate the clinical effect (objective     response rate) of the vaccination regime.   "
180465|NCT00197938|"     Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of     oxygen. This leads to increased formation of lactic acid.      The investigators hypothesize, that the more serious the condition, the higher the     concentration of lactic acid will be, thus relating to the risk of multiple organ failure or     death.   "
180466|NCT00197951|"     Alcohol dependent patients show comorbid psychiatric symptoms, related to malfunction of     dopamine, norepinephrine and serotonin neurotransmission, during early recovery. Ziprasidone     can improve malfunctioning of these disregulated systems, thereby improving anxiety,     depression, anhedonia, anger, and alcohol craving.   "
180467|NCT00197964|"     Among 180 patients with moderate asthma, the specific aim of this randomized trial is to     assess the effectiveness of an intervention involving education, enhancement of     self-efficacy, and asthma social support in preventing deterioration in functional status     over two years.   "
180468|NCT00197977|"     The goals of this study are to develop and test an educational intervention to address     patients' expectations of long-term outcomes of total knee arthroplasty.   "
180469|NCT00197990|"     The goals of this study are to identify predictors of improvement in quality of life and     satisfaction with total hip arthroplasty three to five years after surgery.   "
180470|NCT00198003|"     The goals of this study are to develop and test an educational intervention to address     patients' expectations of long-term outcomes of total hip arthroplasty.   "
180471|NCT00198016|"     Background and Purpose: Congenital coronary artery fistula (CAF) is an uncommon anomaly. In     some patients they can became symptomatic, associated with significant morbidity and     mortality. We report our experience in percutaneous treatment of CAF.   "
180472|NCT00198029|"     The purpose of this study is to find out if hyaluronan, an injectable medication for knee     arthritis, also works for arthritis at the base of the thumb. This study will also evaluate     how good ultrasound is at visualizing medication in the thumb joint. We are no longer     recruiting for this part of the open label trial.   "
180473|NCT00198042|"     Hypothesis 1: There is less tunnel-widening with bone-patella tendon-bone graft compared with     the hamstring graft when the same fixation method is used. Tunnel widening is greater with     achilles tendon allografts versus autograft bone-patella tendon-bone and hamstring     autografts.      Hypothesis 2: Tunnel widening occurs in the early post-operative period (< 8 weeks) when the     tendon remodels within the bone tunnels.      Hypothesis 3: Low pre-operative bone mineral density is associated with tunnel widening.   "
180474|NCT00198055|"     The purpose of this study is to develop a better tolerated and more effective pharmacologic     treatment for individuals with Asperger's Disorder and Pervasive Developmental Disorder. This     is an open-label investigation of aripiprazole in the management of the maladaptive behaviors     of autistic disorder. We hypothesize that aripiprazole will be effective for reducing     aggression and repetitive behavior.   "
180475|NCT00198068|"     The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major     clinical centers. The purpose of the study is 1) to determine whether certain proteins     (called complement split products) that can injure healthy organs can be used to predict poor     pregnancy outcome in patients with systemic lupus erythematosus (SLE) and anti-phospholipid     syndrome (APS), and/or 2) to determine whether elevated levels of circulating antiangiogenic     factors predict pregnancy complications in patients with aPL antibodies and/or SLE.   "
180476|NCT00198081|"     The purpose of the study is to find out whether the drug celecoxib has beneficial effects on     people with pre-cancerous lesions of the pancreas.   "
180494|NCT00198328|"     The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with     regard to local tumor recurrence, disease-free survival, and overall survival rates versus     surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the base of the     tongue, posterior lateral pharyngeal wall, hypopharynx or larynx.   "
180477|NCT00198094|"     The primary objective for the study is to test the hypothesis that sertraline plus alprazolam     XR will result in superior early stabilization of primary care PD patients versus     sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are     a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial)     and after discontinuation, b) to compare physical health outcomes, medical services     utilization, and cost-effectiveness of the two study interventions across the 12-week     treatment period and subsequent three month maintenance treatment with sertraline alone, and     c) to assess whether early co-administration of sertraline/ alprazolam XR will result in     greater maintenance of treatment response than sertraline/placebo over the three months     following the 12 week acute treatment program.   "
180478|NCT00198107|"     This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating     symptoms associated with autism in children.   "
180479|NCT00198120|"     This study will determine the effectiveness of D-cycloserine in reducing symptoms of autism     in autistic children.   "
180480|NCT00198133|"     To study the efficacy of Alimta as a single agent in thymic cancers   "
180481|NCT00198146|"     The primary purpose of this study is to determine the efficacy and safety of daclizumab in     preventing the progression of diabetes in children who have just been diagnosed with type I     diabetes. Additional purposes of the study are to investigate the amount of drug in the     children, how quickly it is eliminated from the blood, and analyze the effect of the drug on     the immune reaction to diabetes.   "
180482|NCT00198159|"     This study will evaluate the use of ZD1839 in the treatment of subjects with refractory germ     cell tumors. Subjects will take ZD1839 for one year in the absence of excessive toxicity or     decision to withdraw.   "
180483|NCT00198172|"     This study proposes to evaluate the combination of cisplatin plus epirubicin in patients with     refractory germ cell tumor not amendable to cure with surgery or standard platinum salvage     chemotherapy. This regimen will be used in eligible patients after progression on ECOG Study     E39897.   "
180484|NCT00198185|"     Hypothesis: The use of cascade platelet-rich fibrin matrix (PRFM) on medium and large sized     rotator cuff tears will improve patient results versus the control results by 50%.      The purpose of this study is to examine the effect of PRFM on rotator cuff repairs. Since     locally applied platelet-derived growth factor (PDGF) has shown early promise in enhancing     tendon and ligament healing in anterior cruciate ligament (ACL) and medial collateral     ligament (MCL) reconstruction, the investigators believe that locally applied PRFM will     enhance the quality of rotator cuff repairs.   "
180485|NCT00198198|"     This is a study of addition of aripirazole to the treatment of bipolar depressed patients who     are not better on the medications that they are currently receiving.   "
180486|NCT00198224|"     Valganciclovir (VGCV) has recently been approved by the Food and Drug Administration (FDA)     for the treatment and prevention of cytomegalovirus (CMV) retinitis in HIV patients. It is     under review for the prevention of CMV disease following organ transplantation. Mycophenolate     mofetil (MMF), the morpholinoethyl ester of mycophenolic acid (MPA) is currently the most     widespread used immunosuppressant in kidney transplantation. These drugs exerts their effects     by blocking the production of DNA primarily in lymphocytes.      Recent studies have suggested that combining both MMF and GCV in vitro may have a beneficial     effect on the treatment of CMV infections. However, the effect of these two drugs in     combination on the effects of the immune system both in vitro and in vivo have not been     studied. Preliminary studies in our lab show that a combination of these two drugs have an     additive effect on the level of immunosuppression of both the growth and differentiation of     progenitor bone marrow cells as well as lymphocyte proliferation.      This study is designed to test patients degree of immune reactivity both on and off VGCV when     used in combination with MMF. Patients will have blood drawn as several time points and an     immune assay will be performed to show if VGCV when used in combination with MMF exerts     immunosuppressive effects.   "
180487|NCT00198237|"     The primary objective of this study is to determine the efficacy & toxicity of combined     docetaxel & capecitabine as primary chemo for subjects w/ stage II-III breast cancer.   "
180488|NCT00198250|"     The purpose of this study is to evaluate Venlafaxine as a treatment option for hot flashes in     breast cancer survivors. The goals of this study are to assess the effectiveness and toxicity     of venlafaxine hydrochloride and identify the psychological, behavioral, and physical     outcomes associated with relief of hot flashes in women following treatment for breast     cancer.   "
180489|NCT00198263|"     The purpose of the trial is to study the safety and efficacy of the Medpulser Electroporation     System with bleomycin in the treatment of head and neck cancer.   "
180490|NCT00198276|"     The purpose of the study is to study the safety and efficacy of MedPulser Electroporation     with bleomycin treatment of cutaneous and subcutaneous foci of cancer.   "
180491|NCT00198289|"     Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus     aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis®     intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized     monoclonal antibody that is designed to combat Staphylococcus aureus.      The purpose of this study is to assess the safety and pharmacokinetic profile (concentration     of Aurexis in blood and sputum) of Aurexis. Additionally, certain tests and measurements will     be conducted to preliminarily determine if Aurexis demonstrates any benefit to these     patients.   "
180492|NCT00198302|"     Hospitalized patients at least 18 years of age, with Staphylococcus aureus bacteremia (SAB)     will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day     1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that     is designed to combat Staphylococcus aureus.      The purpose of this study is to assess the safety and pharmacokinetics of standard antibiotic     therapy, plus Aurexis or Placebo for treatment of (SAB). Additionally, certain tests and     measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit     to these patients.   "
180493|NCT00198315|"     The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with     regard to local tumor recurrence, disease-free survival, and overall survival rates versus     surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the anterior oral     cavity, soft palate, or tonsil.   "
180495|NCT00198341|"     The follow-up of patients operated on for lung cancer is heterogeneous. An intensive     follow-up including routine clinic visits, chest X-rays, chest computed tomography (CT) scans     and fiberoptic bronchoscopies might detect more small, potentially curable, recurrences and     second cancers. However, as it appears in the American Society of Clinical Oncology (ASCO)     recommendations, a large randomized study is necessary to evaluate the survival impact of     such a follow-up strategy. This is the main objective of this IFCT-0302 study, which is a     large randomized controlled study conducted in France comparing this intensive follow-up to a     follow-up with only routine clinic visits and chest X-rays.   "
180496|NCT00198354|"     The addition of chemotherapy to lung cancer surgery is now considered as the standard of     care. Solid data support postoperative chemotherapy but only few results are available in the     preoperative setting. To define which timing of perioperative chemotherapy offers the best     survival improvement, the IFCT 0002 study is conducted in France.   "
180497|NCT00198367|"     Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2     account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the     results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or     radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests     of exclusive CT, or in noncomparative tests of RT-CT.   "
180498|NCT00198380|"     Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological     pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and     BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for     resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced     P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine     kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid,     dramatic responses, possibly reflecting specific molecular differences from other non-small     cell lung carcinomas.   "
181338|NCT00216008|"     The purpose of this research study is to find out the effectiveness of the experimental     combination of Docetaxel, Cisplatin, and radiation therapy administered prior to the surgical     removal of your esophageal cancer.   "
180499|NCT00198393|"     Patients presenting a deterioration of the general state (performance status [PS] 2-3),     constitute a population which needs an adapted treatment. An analysis was made of the     evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594     trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel,     docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to     the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end     of this study, with the analysis of total toxicity, this one was not higher than that noted     in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been     noted, but the analysis showed that only 2 were due to the treatment. It was noted that the     lower survival compared to the others was related to the disease and not to the treatment.     These patients are often symptomatic and need palliative treatment. The benefit of     chemotherapy should not be denied. They should profit from a monochemotherapy with the new     cytotoxic agents, without associated platinum salt.   "
180500|NCT00198406|"     Management of lung cancer remains very controversial for elderly patients (pts) and they are     often excluded from clinical trials. We present here a survey performed about the management     of lung cancer pts aged 70 or more in France. All pts aged 70 or more with     histo/cytologically proved lung cancer diagnosed between sept 02 and oct 03 in participating     centers were recorded and their characteristics, the diagnostic procedures, therapeutic     management and survival were analysed.   "
180501|NCT00198419|"     The objective of this study was to rule out a greater than 10% incidence of hypersensitivity     to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or     equal to 10% hypersensitivity response was considered acceptable.   "
180502|NCT00198432|"     To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC     stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a     induction chemotherapy, or followed by a consolidation chemotherapy.   "
180503|NCT00198445|"     The primary objective of this study was to investigate the efficacy of bromfenac sodium     ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who     undergo cataract extraction and intraocular lens implantation. The secondary objective was to     investigate the safety and tolerability of the same.   "
180504|NCT00198458|"     The objective of this study was to rule out a greater than 10% incidence of hypersensitivity     to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or     equal to a 10% hypersensitivity response was considered acceptable.   "
180505|NCT00198471|"     The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to     induce posterior vitreous detachment(PVD) in subjects with moderate to severe     non-proliferative diabetic retinopathy.   "
180506|NCT00198484|"     The purpose of this study is to determine whether Vitrase (hyaluronidase for injection) is     effective as a spreading agent for other injected drugs prior to ocular surgery   "
180507|NCT00198497|"     The purpose of this study is to determine if intravitreal injection of Vitrase (ovine     hyaluronidase) clears vitreous hemorrhage   "
180508|NCT00198510|"     The purpose of this study is to determine if intravitreal injection of Vitrase (ovine     hyaluronidase) clears vitreous hemorrhage   "
180509|NCT00198523|"     The purpose of this study is to demonstrate the bioequivalence of the combination test agent,     prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte     (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by     comparing aqueous humor concentrations of prednisolone acetate.   "
180510|NCT00198536|"     The purpose of this study is to determine whether ecabet ophthalmic solution is an effective     treatment for dry eye syndrome   "
180511|NCT00198549|"     The purpose of this study is to evaluate Vitrase as an adjuvant to increase absorption and     dispersion of other injected anesthetics   "
180551|NCT00204919|"     Administration of vitamin D 50,000 units once monthly will:        -  Maintain serum 25-OH vitamin D above 20 ng/ml        -  Reduce falls        -  Increase calcaneal BMD        -  Reduce bone turnover        -  Be well tolerated: volunteers will not develop hypercalcemia        -  Improve performance on a swallowing quality of life questionnaire   "
180706|NCT00211211|"     The primary objective of this study is to compare the effectiveness of standard medical     therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body     compression fractures.   "
180512|NCT00198562|"     The aim of this trial is to study the effects of antihypertensive therapy based on home     systolic blood pressure (BP) with different target levels using two classes of drugs.      The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. The     study subjects are 40-79 years old hypertensive patients. After a 4 weeks of baseline period,     subjects are randomly assigned to (1) modest control group (morning home BP <140 mmHg) or (2)     strict control group (morning home BP <130 mmHg), and to (a) amlodipine group or (b) losartan     group. Additional antihypertensive drugs can be used if home BP is not controlled. Home BP is     measured in the early morning and late evening. The participants will be followed up for 5     years.   "
180513|NCT00198575|"     Several clinical studies in Western countries have revealed that the prevalence of HIT is 0.5     to 5%, varying depending on the clinical setting. Thirty to 50% of HIT patients suffer from     thromboembolic events, and the mortality of HIT is 10 to 20%. In contrast, many physicians in     Japan report no experience in treating HIT, although approximately 200,000 patients per year     receive heparin. This raises the possibility that the prevalence of HIT might be much lower     in Japan than in Western countries. In fact, neither the drug for HIT treatment nor the     laboratory test for HIT diagnosis has been approved by the Pharmaceutical Affairs Law in     Japan. We have therefore conducted a multi-center, prospective cohort study to determine the     prevalence and profile of HIT in patients undergoing cardiovascular surgery or percutaneous     coronary intervention. Approximately 1,500 patients will be enrolled in this study.   "
180570|NCT00209430|"     The main purpose of this study is to evaluate and compare the effects on kidney function of     two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at     risk of kidney damage associated with the injection of contrast media. A standard hydration     procedure, based on available guidelines will be given to all patients to prevent negative     effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up     to 7 days after contrast media administration to evaluate the effects on renal function.   "
180514|NCT00198588|"     The purpose of the study is to evaluate efficacy and safety of argatroban in the patients     with heparin-induced thrombocytopenia (HIT)/ HIT and thrombosis syndrome (HITTS). This     multi-center trial covers mainly the patients with cardiovascular diseases. Subjects are     included in the trial when they are clinically diagnosed of HIT/HITTS. Initial dose of     argatroban is 0.7μg/kg/min, which is about one-third of the approved dose in the US. The     reason of the lower initial dose is that the approved dose of argatroban in Japan (for the     treatment of ischemic stroke) is about 0.7μg/kg/min and safety of higher doses of the drug     are not confirmed. A sub-study of pharmacokinetics is simultaneously conducted to reveal the     relationship among the dose, aPTT, and blood drug concentration.   "
180515|NCT00198601|"     The purpose of this study is to determine what dosage of gentamicin for use in one-time     administration device (Uniject) is appropriate.   "
180516|NCT00198614|"     Postoperative new-onset atrial fibrillation (AF) is the most common complication stemming     from coronary artery bypass graft surgery, and is associated with increased early and late     mortality risk. Standard guidelines recommend β blockers for the prevention of AF; however,     no prospective study has compared the relative efficacy of β-blocking agents. We hypothesize     that carvedilol, a non-selective adrenergic blocker with both anti-inflammatory and     antioxidant properties, is more effective than metoprolol, a conventional β1-selective     antagonist, in suppressing new-onset AF following off-pump coronary bypass surgery. We have     designed the Carvedilol or Metoprolol Post-Revascularization Atrial Fibrillation Controlled     Trial (COMPACT) to test our hypothesis in a multi-center, open-label, and randomized     controlled trial.   "
180517|NCT00198627|"     The purpose of this study is to determine what are the major types of bacteria that cause     newborn infections in the community in rural Bangladesh and whether providing an obstetric     and neonatal care package will reduce neonatal deaths by 40%.   "
180518|NCT00198640|"     This study looks at the usage of human antibiotics for treatment of animals in Bangladesh.   "
180519|NCT00198653|"     The purpose of this study is to train mothers/caretakers on how to prevent their babies from     becoming too cold.   "
180520|NCT00198666|"     This study is designed to evaluate the efficacy of zinc supplementation in the treatment of     children under the age of two years who have been hospitalized with severe pneumonia.   "
180521|NCT00198679|"     Given the potential of skin cleansing with chlorhexidine as a safe, feasible, and     cost-effective intervention for reducing neonatal death in developing country settings, this     study follows a trial already underway in Nepal to test the impact of a single cleansing of     the skin with baby wipes cotaining chlorahexidine.   "
180522|NCT00198692|"     The specific aims of this study are:        1. To develop and pilot a self-management (SM) intervention for persons with limb loss in a          group setting using a participatory action research (PAR) strategy.        2. To evaluate the feasiablity and effectiveness of a SM intervention within the context of          the existng network of limb loss peer support groups           Hypothesis #2a: The SM intervention groups will be more effective than standard support          group activities in reducing pain, depression and anxiety, and increasing positive mood          and improving function and overall quality of life.           Hypothesis #2b: Improvements in pain, depression, anxiety, function and quality of life          will correlate strongly with improvements in self-efficacy, catastrophizing, and          satisfaction with the prosthesis and prosthetic services.           Hypothesis #2c: Gains in outcome will be maintained for one year.           Hypothesis #2d: Characteristics of study participants and their environment (i.e.          sociodemographics, co-morbidities, economic and educational resources, hope, and social          support) will correlate with outcome and mediate the effect of the intervention.        3. To determine the costs of the intervention and examine the relationship between costs          and effectiveness.      Hypothesis #3a: When compared to the control support group, the SM intervention will be     cost-effective in terms of gains in quality adjusted years of life.   "
180523|NCT00198705|"     This project delivers, promotes and facilitates services related to pregnancy, delivery and     newborn care.   "
180524|NCT00198718|"     The ZVITAMBO PROJECT is testing whether giving mothers and infants a single large dose of     vitamin A during the immediate post partum period will reduce:        1. Infant Mortality Can oral administration of a single 50,000 IU dose of vitamin A to          newborn infants, a single 400,000 IU dose of vitamin A given to their lactating mothers,          or supplementation of both the mother and infant during the immediate post partum period          reduce infant mortality by at least 30%?        2. Mother to Child HIV transmission during breast feeding Can oral administration of a          single large dose of vitamin A given during the immediate post partum period to HIV          seropositive lactating women and/or their babies reduce HIV transmission via breast          feeding by at least 30%?        3. Sexually transmitted HIV infection of post partum women Can a single 400,000 IU dose of          vitamin A given during the immediate post partum period to HIV seronegative women reduce          their likelihood of becoming HIV infected during the post partum year by at least 25%?        4. Infant feeding in the context of HIV: An operational research study was initiated          mid-way through the trial to determine how UNAIDS Guidelines on infant feeding in the          context of HIV could be effectively implemented and to measure the impact of such a          program on infant feeding practices and postnatal HIV transmission.      Substudies:      Random subsamples of maternal and infant blood were evaluated for anemia and iron status to     determine the effect of vitamin A on hematopoiesis and serum and breast milk retinol     (mothers) and modified relative dose response test (infants) to determine the effect of     vitamin A on vitamin A status.      A subsample of maternal and infant blood samples were evaluated for the presence of HLA-E,     HLA-G, and TAP polymorphisms and their relation to prevalent HIV infection in mothers and     risk of mother to child transmission.   "
180525|NCT00198731|"     Maternal death is a substantial burden in developing countries. In Bangladesh, recent studies     have suggested that a large proportion of women giving birth in rural areas experience     pregnancy and delivery related complications. This study, which is set in context where     home-birth is the norm, provides the opportunity to provide descriptive information on the     self-reported prevalence of maternal behaviors and morbidities during pregnancy, delivery and     postpartum periods and to quantify the effects of provision of maternal care interventions     through trained community health workers on a few selected maternal behaviors and     morbidities.   "
180526|NCT00198744|"     1. Does a joint parent-child dieting approach, as opposed to an individually-based          approach, improve weight loss outcomes?        2. Is a diet which includes Medifast meal replacements as efficacious as a non-supplemented          Food Guide Pyramid-based diet (reference diet) in achieving better adherence to the          diet, initial weight loss, reduction in % body fat, and weight maintenance?        3. Does regular use of Medifast meal replacements, in conjunction with a Food Guide          Pyramid-based diet, result in significantly better compliance, greater dietary          satisfaction, dietary quality, and palatability than the reference diet?        4. Do children who have lost weight using Medifast meal replacements, as an adjunct to a          Food Guide Pyramid-based diet, achieve health benefits compared to baseline values and          are these health benefits greater than those obtained following the reference diet?   "
180527|NCT00198757|"     The objective of this study is to evaluate the efficacy of Medifast Plus for Diabetics     compared to a standard weight loss treatment program, in terms of changes in weight loss in     overweight men and women over an 86 week active weight loss and weight maintenance program.     There will be up to 34 weeks active weight loss and 52 weeks weight maintenance. The planned     sample size is 80 overweight (BMI 25-40) males and females aged 18-65 with type 2 diabetes.     It is anticipated that pre-packaged meal replacements will provide an advantage to those     desiring weight loss.   "
180528|NCT00198770|"     Unfortunately, current methods of achieving weight control are disappointing. There is also a     great deal of public confusion over what constitutes an appropriate diet for weight control;     there is a paucity of carefully performed, randomized, controlled clinical treatment trials     to evaluate the varying opinions. Mushrooms are not widely appreciated as the nutritious, low     calorie, low fat food (and potential meat substitute) that they are. Mushrooms may be a new     diet food, especially as a substitute for higher calorie and fat staples like meat.      This study examines whether there is compensation for the potential calorie and fat savings     of substituting mushrooms for meat in dishes over a 4-day period.   "
180529|NCT00198783|"     The objective of this study will assess the feasibility of utilizing real-time data     monitoring in future clinical trials of weight control medications and other treatment     modalities, along with the feasibility of distinguishing different types of relapses over 16     weeks: There will be 4 weeks of high-intensity EMA and 12 weeks of low-intensity EMA. Each     participant will be in the study for 52 weeks with 20 visits, including follow-up visits.   "
180530|NCT00198796|"     Five subjects will be admitted to the General Clinical Research Center (GCRC). The next day     they will eat a light breakfast, fast for 90 minutes, ingest ETEC strain H10407, and fast for     90 more minutes. After this challenge they will be monitored closely , and all stools will be     collected, graded and weighed. On Day 5, or sooner if indicated, they will begin antibiotics     to eradicate the challenge strain. They will be scheduled for discharge on Day 7 but may     leave a few days earlier if early antibiotic treatment is given.      Hypothesis:      A challenge dose of 10(9) colony forming unit (CFU) of ETEC strain H10407, will cause     diarrhea in at least 60% of subjects.   "
180531|NCT00198809|"     Effects of herbal products on weight loss, weight maintenance and metabolic rate.        -  The objective of this study is to evaluate the efficacy of two herbal weight loss          products, BioLean and BioLean Free compared to each other and a matching placebo, in          effects on appetite suppression, changes in metabolism, weight loss, and safety in          overweight men and women over a 12 month active weight loss and weight maintenance          program.        -  This is a randomized double-blind study. The planned sample size is 180 healthy,          overweight (BMI 27-40) males and females aged 18-60.   "
180532|NCT00198822|"     The purpose of this trial is to determine whether providing women with a weekly oral     supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a     recommended intake from early pregnancy through three months postpartum, can reduce the risk     of maternal mortality, fetal loss, or infant mortality.   "
180533|NCT00198835|"     This study is designed to evaluate the effectiveness of CARE India's Integrated Nutrition and     Health Program (INHP II) to reduce malnutrition among children 0-23 months of age.   "
180534|NCT00198848|"     This study will implement and evaluate a community-based intervention to distribute and     promote consumption of weekly iron-folic acid supplements and to provide nutrition education     to reduce the prevalence of iron deficiency anemia among adolescent girls in West Bengal,     India.   "
180552|NCT00204932|"     Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural     sources. When given to small animals, decreases of body fat have been noted.. Although weight     loss is the best treatment for overweight and obesity, it is difficult to maintain the loss     in the long term. Because of this, treatment emphasis has turned to small weight losses     obtained through non-restrictive diets and prevention of weight regain. This is a study to     determine if 6 months of consumption a purified form of CLA will result in greater loss of     body fat than control and to determine whether CLA consumption increases total fat oxidation,     which would help explain why the weight loss occurs.   "
180582|NCT00209586|"     This study was designed to demonstrate that AQUAVAN® is effective in providing adequate     sedation in patients undergoing flexible bronchoscopy as well as to assess the safety profile     of AQUAVAN versus that of midazolam. Prior to the procedure, patients receive fentanyl     citrate for pain management followed five minutes later by either AQUAVAN® Injection or     midazolam HCl for sedation. During the procedure, study personnel assess the patient's vital     signs and depth of sedation. After the procedure, the patient, physician, and an evaluator     are asked to complete satisfaction surveys.   "
180813|NCT00211978|"     The purpose of this study is to determine if calcium acetate (PhosLo) can control serum     phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.   "
180553|NCT00204945|"     1. Research question: What is the response of the heart's pumping function to changes in          heart chamber pressures?        2. Experimental design: Patients undergoing routine cardiac catheterization will be          studied. A thermodilution pulmonary artery catheter will be inserted through a venous          sheath and threaded into the pulmonary artery. After several minutes of quiet rest,          baseline hemodynamics will be obtained, including a determination of cardiac output          using thermodilution techniques and 30 seconds of pressure recordings from the left          ventricle and proximal aorta. In addition, a brief echocardiogram will be performed, to          determine ejection fraction and indices of diastolic filling. Finally, arterial          tonometry will be obtained in quick succession from the brachial, radial, femoral, and          carotid arteries. Following the collection of baseline data, a bolus and infusion of          nesiritide will be started. After 10 minutes of nesiritide infusion, with the drug still          infusing, a full set of invasive hemodynamics will again be obtained, as well as brief          echocardiographic and arterial tonometry examinations.   "
180588|NCT00209664|"     To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and     survival period. by performing a phase II study of this combination in patients with     inoperable or with postoperative gastric cancer   "
180589|NCT00209677|"     To assess the usefulness of Gemcitabine plus S-1 therapy based on the antitumor effect and     survival period. By performing a phase I/II study of this combination in patients with     inoperable or with postoperative pancreatic cancer.   "
180535|NCT00198861|"     The purpose of this R01 study is to evaluate the association between neuropsychological     executive dysfunction and HIV infection among young injection and non-injection drug users. A     longitudinal study will be conducted in which the cohort of seronegative drug users     completing a baseline neuropsychological battery are re-assessed on three subsequent     occasions, roughly six months apart. The primary aim of the longitudinal study is to estimate     the magnitude of the suspected causal relationship between executive dysfunction and HIV-risk     behaviors while adjusting for time-invariant (e.g. sex, ethnicity) and time-varying (e.g.     degree of drug abuse) covariates. We also seek to evaluate: (1) the degree to which specific     executive dysfunctions predispose heroin and cocaine users to high-risk injection practices     or sex behaviors, and (2) whether observed relationship between executive dysfunction and     HIV-risk behaviors can be understood independent of levels of drug -taking frequency, or     whether the observed data are more consistent with complex patterns of interdependency     between executive dysfunction, drug-taking frequency, and HIV-risk-behaviors. If successful,     this project will shed new light on significant and potentially malleable HIV-risk factors in     injection and non-injection drug users. This will be important evidence because injection     drug abuse continues to account for a large proportion of HIV seroconversions particularly     among young women and minorities. As such, this RO1 research project serves as an important     initial step in a line of innovative investigations about suspected causal associations     between neuropsychological deficits and HIV-risk behaviors in drug users. Ultimately, this     line of investigation should lead to changes in public and clinical practices designed to     prevent HIV infection.   "
180536|NCT00204711|"     The purpose of this study is to determine if the SNAP II electroencephalography (EEG) monitor     accurately reflects changes in sedation level in outpatients undergoing surgery or procedures     with sedation.   "
180537|NCT00204737|"     The purpose of this study is to investigate if a 2-wk course of 20mg/day of oral prednisone     in addition to standard care will result in reduced PTSD symptoms or symptom severity     compared to placebo   "
180538|NCT00204750|"     The primary objective of this study is to compare the efficacy of bougie dilation to     electrosurgical incision of symptomatic schatzki's rings at one year follow-up in the     presence of rabeprazole treatment. All patients will be followed for one year for recurrence     and/or severity of dysphagia and will be placed on rabeprazole for that time period.   "
180539|NCT00204763|"     The primary objective of this study is to compare the accuracy of esophageal and anorectal     manometric pressure measurements using a newly developed air filled balloon catheter with     present standard solid state esophageal and anorectal catheters, respectively.   "
180540|NCT00204776|"     Both capecitabine and oxaliplatin have single agent activity in breast cancer. The     combination has improved activity in other solid tumors. This study seeks to assess the     activity of the combination in breast cancer.   "
180541|NCT00204789|"     This is a double blind, placebo controlled study of 52 patients who are at least one-year     post-solid organ transplant. Subjects will receive either 12 months of DFMO or a placebo. The     specific aims are to determine if DFMO at 500 mg daily will be well tolerated for 12 months     and not affect organ transplant viability; will inhibit 12-O-tetradecanoylphorbol-13-acetate     (TPA)-induced ornithine decarboxylase (ODC) in skin biopsies by approximately 50% for the 12     months of therapy; and will be able to decrease polyamine levels in skin biopsies for the 12     months of treatment.   "
180542|NCT00204802|"     Based on theories regarding decision-making and patient education the investigators have     developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to     improve patient and surrogate knowledge of ACP, increase the congruence between patient and     surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making     such decisions, and increase the consistency between patient preferences and the actual care     they receive. The ACP intervention is conducted with the patient in the presence of the     surrogate.   "
180543|NCT00204815|"     What are the effects of the currently used AEDs on bone mineralization in children and     adolescents between the ages of 8 to 18? This is a pilot observational study using DEXA scans     to measure bone mineral density in 100 patients The primary objective is to collect     preliminary data on bone mineral density, body weight, dietary calcium intake, and activity     level.   "
180544|NCT00204828|"     This is an epidemiologic study, examining environmental exposures and affect on immune     development.   "
180545|NCT00204841|"     Although asthma is likely to be a heterogeneous disease or syndrome, three factors and/or     events repetitively emerge for their ability to significantly influence asthma inception in     the first decade of life: immune response aberrations, which appear to be defined best by the     concept of cytokine dysregulation; lower respiratory tract infections (in particular RSV);     and some form of gene by environment interaction that needs to occur at a critical time     period in the development of the immune system or the lung. It remains to be firmly     established, however, how any one or all of these factors, either independently or     interactively, influence the development of childhood asthma. Thus, our efforts to determine     and define the importance of these three factors to asthma pathogenesis are the focus and     goal of this current grant application.   "
180546|NCT00204854|"     Randomized controlled trial and benefit-cost study of a telephone and mail intervention for     non-treatment-seeking primary care patients with alcohol abuse or dependence   "
180547|NCT00204867|"     This study involves a primary VC screening for colorectal polyps. The research hypothesis is     that VC screening, including surveillance of sub-cm polyps, is a safe and effective approach.   "
180548|NCT00204880|"     Hypotheses:        1. Subjective self-reported data can be used to accurately reflect functioning across the 5          key domains.        2. Cancer and its various treatment modalities will exert detrimental effects on the 5 key          domains in older adults with cancer.        3. Some aspect of baseline patient characteristic will be predictive of cancer-related          outcomes.   "
180549|NCT00204893|"     This is a Phase I, single center, open-label study of the dietary supplement calcium formate     in normal, healthy female subjects. The purpose of the study is to determine whether daily     use of calcium formate is safe and whether it accumulates in the eye.   "
180550|NCT00204906|"     Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized     that part of this neglect is due to absence of data documenting safe and effective ways to     replete this inadequacy.   "
180554|NCT00204958|"     Nutrition is an important part of the recovery process after having a head injury so that     subjects can gain strength and fight off infection. Liquid nutrition formulas are often given     to patients through a tube that has been placed into the intestines for feeding when they are     unable to eat on their own. Some reports suggest that nutrition with extra amounts of the     amino acid called glutamine may decrease infections and hospital stay in severely injured     patients. The purpose of this study is to evaluate if giving extra amounts of an amino acid     called glutamine with liquid nutrition formulas will decrease the risk of infection and     length of stay in the intensive care unit after having a head injury.   "
180555|NCT00204971|"     Nutrition is an important part of the recovery process after having a head injury so that     subjects can gain strength and fight off infection. Liquid nutrition formulas are often given     to patients through a tube that has been placed into the intestines for feeding when they are     unable to eat on their own. Some reports suggest that nutrition with extra amounts of the     amino acid called glutamine may decrease infections and hospital stay in severely injured     patients.The purpose of this study is to evaluate if giving extra amounts of an amino acid     called glutamine with liquid nutrition formulas will decrease the risk of infection and     length of stay in the intensive care unit after having a head injury.   "
180556|NCT00204984|"     Does dilation of blood vessels (vasodilation), which decreases aortic stiffness, have a     greater effect on heart myocardium relaxation (diastole) than vasodilation which affects mean     pressure equally without improving aortic stiffness?   "
180557|NCT00204997|"     The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic     ovarian transposition in women less than 40 years of age with locally advanced cervical     squamous cell carcinoma   "
180558|NCT00205010|"     The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic     ovarian transposition in women less than 40 years of age with locally advanced cervical     squamous cell carcinoma   "
180559|NCT00205023|"     The purpose of study is to: 1) determine critical volume necessary to overcome tubal pressure     and result in fluid dissemination and 2) evaluate functional viability of any disseminated     tumor cells collected during SHG   "
180560|NCT00205036|"     We, the investigators at the University of Wisconsin, hypothesized that ingesting calcium     tablets prior to a spine bone density scan will not affect the bone mineral density as     measured by dual energy x-ray absorptiometry (DXA).   "
180561|NCT00205049|"     The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to     placebo in AAH while studying putative mechanisms that are plausible and testable. The main     hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.   "
180562|NCT00209326|"     • To determine the effects of four different single bolus doses of FE200440 administered     intravenously on stopping preterm labour compared to placebo in pregnant women with advanced     gestational age   "
180563|NCT00209339|"     Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System     (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month,     12 month, and 5 year clinical follow-up.   "
180564|NCT00209352|"     The objective of this study is to prevent reactivation of herpes zoster during the first year     after transplant.   "
180565|NCT00209365|"     The aim of the study is to explore the contribution of pollen starch granules to the induced     symptoms and airway inflammation in patients with allergic rhinitis and mild asthma in a     controlled pollen exposure(pollen challenge room at the Fraunhofer ITEM). Starch granules are     released from the pollen grains and are considered to be the allergen carriers of the pollen.     The hypothesis is proposed that pollen starch granules are important in the induction of     airway inflammation and airway hyperresponsiveness.   "
180566|NCT00209378|"     The purpose of this study is to compare citrate regional anticoagulation with systemic     heparinization in continuous venovenous hemofiltration. The investigators' hypothesis is,     that regional citrate anticoagulation with replacement solution containing trisodium citrate,     will be associated with lower mortality and less bleeding complications compared to heparin,     with also a better filter survival.   "
180567|NCT00209391|"     Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging     (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow     in the arterial vessels throughout the body.      Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by     directly injecting it into the vein, but this procedure has not been formally tested to image     the renal artery vessels using MR.      The study is designed to determine the presence or absence of a relevant stenosis (ie greater     than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction     Angiography will be used as the standard of truth.   "
180568|NCT00209404|"     Image quality in coronary artery computed tomography is influenced by the heart rate     variation during the examination. The purpose of this clinical trial is to investigate the     change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol).     Image quality and diagnostic quality of the examination will be evaluated.   "
180626|NCT00210171|"     Feasibility of pragmatic concomitant chemo-radiotherapy association with 1 cycle of Induction     chemotherapy, weekly chemo-radiotherapy, and consolidation chemotherapy.   "
180569|NCT00209417|"     It is well known that X-ray contrast media can affect kidney function in some patients,     especially when administered intra-arterially, and patients who already suffer from reduced     kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use     low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast     media-induced nephropathy. However, little is known about the intravenous use of X-ray     contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose     of this study is to evaluate and compare the effects on kidney function of two contrast     media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney     damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is     expected less influence on renal function following administration of iodixanol. A standard     hydration procedure, based on available guidelines will be given to all patients to prevent     negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured     before and up to 7 days after contrast media administration to evaluate the effects on renal     function.   "
180571|NCT00209443|"     Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging     (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow     in the arterial vessels throughout the body.      Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by     directly injecting it into the vein, but this procedure has not been formally tested to image     the aorto-iliac vessels using MR.      The study is designed to determine the presence or absence of a relevant stenosis (ie greater     than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction     Angiography (IADSA) will be used as the standard of truth.   "
180572|NCT00209456|"     The study is designed to determine the diagnostic efficacy of the visual assessment of SPECT     scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB     dementia subjects determined by the clinical diagnosis of an independent expert consensus     panel used as the standard of truth.   "
180573|NCT00209469|"     This study is evaluating the use of the drug alendronate in preventing or reversing bone loss     in children and adolescents receiving steroid medications.   "
180574|NCT00209482|"     This study will determine if the drug metformin, coupled with diet and exercise counseling,     will help obese adolescents lose weight.   "
180575|NCT00209495|"     Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine.     Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is     unpleasant for the patients and sometimes keeps them at bed longer time than needed. We     investigate in new combinations of analgesics for postoperative pain, hoping to minimize the     need for morphine.   "
180576|NCT00209508|"     This study was designed to assess whether GPI 1485 has the ability to delay or stop disease     progression and improve symptoms in patients with Parkinson's disease (PD) that is already     being treated with a dopamine agonist therapy. Whether the drug is working will be assessed     by evaluating clinical endpoints such as UPDRS scores and by evaluating images, obtained by     SPECT scan, of brain activity. Participants in the study will be given either placebo or GPI     1485 treatment. The duration of the study is 2-years and patients are required to complete 12     safety visits and 3 SPECT scans. SPECT scans will be taken before, after 1-year, and after     2-years of treatment with GPI 1485. In completing the SPECT scan, patients will be injected     with a radioactive investigational drug b-CIT and pictures taken using a Single Photon     Emission Computed Tomography (SPECT) camera.   "
180577|NCT00209521|"     This is an exploratory clinical trial designed to examine the efficacy, safety and     tolerability of fospropofol (AQUAVAN) Injection compared to propofol (DISOPRIVAN) Injectable     Emulsion when used to preoperatively sedate, induce, and maintain general anesthesia and to     postoperatively sedate patients undergoing elective coronary artery surgery.   "
180578|NCT00209534|"     This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing     adequate sedation in patients undergoing colonoscopy. Prior to the procedure, patients     received fentanyl citrate for pain management followed five minutes later by AQUAVAN®     Injection for sedation. Throughout the procedure, study personnel assessed the patient's     vital signs and depth of sedation. After the procedure, the patient, physician, and an     evaluator were asked to complete satisfaction surveys.   "
180579|NCT00209547|"     The anticipation of pain and discomfort, a diagnosis, and other intrinsic unknowns make     patients anxious both prior to and during a procedure. Therefore, the main goal of sedation     with analgesia used during various diagnostic, therapeutic, or surgical procedures is to     relieve this anxiety, discomfort, and pain, which are all interrelated. The optimal level of     sedation for any given patient is one that allows the patient to tolerate the procedure and     provides an appropriate safety margin. This was a study designed to examine the safety and     efficacy of AQUAVAN® Injection versus a commonly used approved sedative drug, midazolam HCl     following pretreatment with fentanyl citrate injection (for pain relief) in producing     sedation in patients undergoing single cardiac catheterization procedures.   "
180580|NCT00209560|"     The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN®     Injection when used for mild-to-moderate sedation in patients undergoing minor surgical     procedures.   "
180581|NCT00209573|"     This study was designed to demonstrate that AQUAVAN® is effective in providing adequate     sedation in patients undergoing colonoscopy as well as to assess the safety profile of     AQUAVAN versus that of midazolam. Prior to the procedure, patients received fentanyl citrate     for pain management followed five minutes later by AQUAVAN® Injection for sedation.     Throughout the procedure, study personnel assessed the patient's vital signs and depth of     sedation. After the procedure, the patient, physician, and an evaluator were asked to     complete satisfaction surveys.   "
180639|NCT00210340|"     The purpose of this study is to define the safety profile of rituximab given intrathecally in     lymphomatous meningitis related to CD20+ non-Hodgkin's lymphomas.   "
180583|NCT00209599|"     This study was designed to demonstrate that AQUAVAN® is effective in providing adequate     sedation in elderly patients undergoing colonoscopy as well as to assess the safety profile     of AQUAVAN versus that of midazolam. Prior to the procedure, patients received fentanyl     citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation.     Throughout the procedure, study personnel assessed the patient's vital signs and depth of     sedation. After the procedure, the patient, physician, and an evaluator were asked to     complete satisfaction surveys.   "
180584|NCT00209612|"     A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting     toxicity (DLT), and efficacy of a combination chemotherapy using CPT-11 and Paclitaxel in     pre-treated patients with metastatic gastric cancer. The usefulness of the this regimen is     evaluated by response rate, median survival time, and progression free survival.   "
180585|NCT00209625|"     We performed a phase I/II study of CPT-11/5FU/l-LV in advanced colorectal cancer, to     determine the optimal dose of CPT-11 and to estimate the safety and efficacy of this regimen   "
180586|NCT00209638|"     To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and     survival period. by performing a phase I/II study of this combination in patients with     inoperable or with postoperative gastric cancer   "
180587|NCT00209651|"     To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and     survival period. by performing a phase II study of this combination in patients with     inoperable or with postoperative colorectal cancer.   "
180590|NCT00209690|"     A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting     toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and     5-fluorouracil (TPF) in untreated patients with metastatic esophageal cancer. The usefulness     of the this regimen is evaluated by response rate, median survival time, and progression free     survival.   "
180591|NCT00209703|"     We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to     estimate the safety and efficacy of this regimen.   "
180592|NCT00209716|"     A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting     toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and     5-fluorouracil (TPF) in Pre-treated patients with metastatic esophageal cancer. The     usefulness of the this regimen is evaluated by response rate, median survival time, and     progression free survival.   "
180593|NCT00209729|"     To assess the usefulness of Docetaxel plus S-1 combination chemotherapy based on the     antitumor effect and survival period by performing a phase I/II study of this combination in     Elderly patients with inoperable or with postoperative gastric cancer.   "
180594|NCT00209742|"     A randomized controlled study is conducted on patients with histological stage III colorectal     cancer assigned to postoperative adjuvant therapy of uracil-tegafur plus leucovorin (UFT+LV),     UFT+LV / UFT, or UFT+LV+PSK / UFT+PSK. The usefulness of the three regimens was evaluated by     comparing the disease-free survival rate, overall survival rate, incidence and severity of     adverse event, and quality of life.   "
180595|NCT00209755|"     Investigation of the usefullness of therapeutical drug monitoring of ribavirin for dose     adaptation during combination therapy of chronic hepatitis C patients.      The correlation between ribavirin plasma concentration levels at week 4 (steady state) and     early virological response (HCV-RNA decay from baseline to week 12) is to be tested in 40     patients approximately.   "
180596|NCT00209768|"     The purpose of this study is to determine whether the use of in-line filtration shows any     effect on the outcome of sepsis, systemic inflammatory response syndrome (SIRS), thrombosis,     or organ failure in critically ill children admitted to the pediatric intensive care unit     (PICU).   "
180597|NCT00209781|"     We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection     afforded by ITNs.   "
180598|NCT00209794|"     To evaluate if intermittent preventive treatment in infants (IPTi) consisting of SP     [Fansidar] given through the EPI scheme alongside routine immunisations at 3, 4 and 9 months     of age reduces de incidence of clinical malaria up to 12 months of age   "
180599|NCT00209807|"     Patients with major depressive disorder (MDD) commonly have many gastrointestinal complaints.     Gastrointestinal pain is classified into 2 categories: visceral and somatic pain. The main     aim of this study is to compare somatic and visceral sensitivity between healthy people and     pateints with MDD. These two sensitivities will be assessed by the 2 following tests:     standardized rectal distension and Transdermal transcutaneous electric nerve stimulation.     Thereafter, patients with MDD will be randomly allocated to escitalopram or reboxetine. After     6 weeks of treatment, somatic and visceral sensitivity will be reassessed.   "
180600|NCT00209820|"     This is a randimized clinical trial comparing the effect of supervised Nordic walking versus     unsupervised Nordic walking versus advice to stay active   "
180601|NCT00209833|"     This randomized phase II/III trial investigates the antileukemic activity and toxicity of the     FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and     bad response to the first induction cycle and/or with a high risk karyotype and compares the     antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous     peripheral blood stem cell transplantation as late consolidation therapy in standard risk     patients.   "
180602|NCT00209846|"     To evaluate the safety and tolerability of gaboxadol in primary insomnia.   "
180603|NCT00209859|"     To investigate whether cyclosporine, added to methotrexate and steroid, increases the     possibility of inflammatory management early in the disease; furthermore to investigate the     possible steroid-sparing effect of cyclosporine in patients with recently diagnosed     rheumatoid arthritis.   "
180660|NCT00210613|"     The primary purpose of the study is to assess the possible withdrawal effects after abruptly     stopping daily therapy with dapoxetine compared with continuing daily therapy in men with     premature ejaculation (PE).   "
180604|NCT00209872|"     The purpose of this study is to test the current standard of care (SOC) treatment for     abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional     perioperative analgesics in terms of postoperative abilities, postoperative nausea and     vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).   "
180605|NCT00209885|"     To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a     group receiving SOC + additional perioperative analgesics in terms of postoperative     abilities, PONV, pain and discharge time from the PACU   "
180606|NCT00209898|"     Hepatitis C infection is a prevalent chronic disease. It is particularly prevalent among     intravenous drug abusers. Bergen fengsel is a regional prison housing 250 inmates, of which     as many as 70 are recorded HCV RNA PCR positive annuallly. In this study inmate males and     females will be randomized to standard screening and initiation procedure, or to a rapid     initiation procedure in the hospital's infectious diseases outpatient clinic. The study aims     at studying if rapid inclusion will increase the possibility to conclude treatment while the     prisoner still is incarcerated, thus improve the chances of reaching a sustained virologic     response, compared to standard inclusion, where prisoners, as other out patients will wait     for inclusion for several months.   "
180607|NCT00209911|"     The main objectives in this study were to examine the cardiac structural and functional     changes in patients with persistent and permanent AF, with the aim of improving our     understanding of the underlying pathophysiological mechanisms. In addition we aimed to     identify variables predictive of recurrent AF.   "
180608|NCT00209924|"     To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia.   "
180609|NCT00209937|"     To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia   "
180610|NCT00209950|"     To evaluate the safety and tolerability of gaboxadol in primary insomnia   "
180611|NCT00209963|"     To evaluate the safety and tolerability of gaboxadol in primary insomnia.   "
180613|NCT00210002|"     The purpose of this study is to evaluate the response rate obtained in an heterogeneous     oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic     treatment or by association of Darbepoetin alfa -ferric saccharose systematic     supplementation, administered concomitantly with chemotherapy.   "
180614|NCT00210015|"     The purpose of this study was to determine the efficacy and safety of the study drug compared     to placebo for the treatment of subjects with perennial allergic rhinitis.   "
180615|NCT00210028|"     The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added     to treatment with tamoxifen   "
180616|NCT00210041|"     The purpose of this study is to determine whether association Gemcitabine-Cisplatin is     effective in the treatment of penis epidermoid carcinoma loco-regionally advanced or     metastatic.   "
180617|NCT00210054|"     The purpose of this trial is to characterize the pharmacokinetics of INS37217 following     intravenous administration.   "
180618|NCT00210067|"     The purpose of this trial is to access the tolerability of INS37217 Intravitreal Injection     when administered intravitreally in subjects with macula-on or macula-off rhegmatogenous     retinal detachment (RRD).   "
180619|NCT00210080|"     The primary objective of this study is to determine if more diagnoses of lung cancer are     obtained from the cytological evaluation of sputum expectorated following a single inhaled     dose of UTP compared to sputum expectorated following a single inhaled dose of placebo in     patients suspected of having lung cancer.   "
180620|NCT00210093|"     The purpose of this trial is to characterize the pharmacokinetics of INS37217 following     intravenous, intranasal, and inhalation administration and to calculate the relative     bioavailability of INS37217 when administered via oral or nasal inhalation.   "
180621|NCT00210106|"     The hypothesis is that radiofrequency ablation combined or not with resection may allow a     local control (the liver) in patients suffering from unresectable colorectal liver     metastases. Patients may have benefit or not from a preoperative (neoadjuvant) chemotherapy.   "
180622|NCT00210119|"     Imatinib mesylate is standard treatment of Chronic myeloid leukaemia, complete cytogenetic     response is obtained in most of cases but molecular response concerned only a small part of     the patients. To increase molecular response ratio we decided to increase imatinib dose to     limited resistance to this drug and to add zoledronate for it anti tumoral activity to     increase anti leukemic effect. We plan to accrue 37 patients in 5 centers. We will analyse     molecular expression of BCR-ABL transcript after 6 months of treatment, safety, duration of     response, VEGF expression and LTgd production.   "
180623|NCT00210132|"     The purposes of this study are:        1. To determine the efficacy of inter pleural analgesia        2. To determine the plasmatic concentration of ropivacaine by inter pleural road   "
180624|NCT00210145|"     The aim of this study is to evaluate the impact of a socio-aesthetic intervention on body     image and quality of life in post-surgical patients with mastectomy or tumorectomy for breast     cancer.Two groups of randomized subjects were constituted. Patients of the experimental group     received 2 or 3 aesthetic care during the first post-surgical week, whereas those of the     control group not. Body image, quality of life and diverse other personality variables were     assessed at three different times: surgical operation day before, exit day before of     hospitalization and three months afterwards. Our general hypothesis is that subjects who     receive aesthetic care report levels significantly higher of corporal satisfaction and of     quality of life at the end of the hospitalization and three months later than patients of the     control group.   "
180625|NCT00210158|"     Peroperative opioids are known to induce N-Methyl-D-Aspartate dependent enhancement of     postoperative hyperalgesia. For patients with current opioid treatment, these phenomena could     be exagerated and could produce greater postoperative opioid consumption and higher pain     score. Since Nitrous oxide has anti- N-Methyl-D-Aspartate properties, the aim of this study     was to evaluate, in patients with current opioid treatment, the effects of peroperative     Nitous oxide on postoperative opioid consumption and pain score, after vertebroplasty.   "
180627|NCT00210184|"     The number of patients over 70 years old with cancer is increasing in France. This population     is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a     lot between subjects of the same age. Physicians hesitate to treat them with optimal doses     because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty     eight percent of gastric cancers are diagnosed in patients over the age of 70 in France.     FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising     treatment for digestive cancer. It increases the level of response and survival without major     toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their     conditions.      The principal objectives are to demonstrate the efficacy of treatment, safety, survival and     to find out if geriatric assessment data can help to better predict chemotherapy toxicity.     The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic     gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day     1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of     cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up     and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and     Lachs-Balducci screening.   "
180628|NCT00210197|"     The risk of deep venous thrombosis after radical breast surgery is known. The objective of     this study is to explore hypercoagulability after radical breast cancer surgery by studying     several factors for haemostasis before, during and after surgery. Ultrasound Doppler     examination is realised between 24 and 72 hours post-operatively. Hypercoagulability is     defined by a significant increasing level of thrombin-antithrombin, D-dimer and the endogen     thrombin potential.   "
180629|NCT00210210|"     The surgery of breast cancer is responsible for post-operative pain, needing in about 30%     some morphine consumption; like that, the association of ketamine with general anaesthesia     may decrease morphine's use and so its adverse effects. The purpose is to evaluate the     analgesic effect of a receptor NMDA's antagonist ( ketamine)   "
180630|NCT00210223|"     To treat breast tumors in non surgical patients with percutaneous technique (radiofrequency).     Prospective evaluation of treatment efficiency and tolerance based on clinical and     radiological evaluation   "
180631|NCT00210236|"     This randomized phase III trial is studying surgery and axillary lymph node dissection to     evaluate if systematic axillary node clearance can be avoided in locoregional treatment for     operable breast cancer smaller than 10 mm among menopausal women older than 50   "
180632|NCT00210249|"     Number of elderly people over 70 is increasing in France. In 2002, in the south-west, 273,741     of them were over 75 years, i.e. 9.2% of Aquitaine population. Incidence of cancer in this     old age is 16,500 new cases per year, more than fifty percent of people with cancer.     Treatment modalities of elderly people is one of the 70 priorities of the Plan cancer     instituted by the French government. They are very few therapeutic trials dedicated.     Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of     breaking down quality of life. Consequently, we decided to launch a protocol with both     oncologists and geriatricians which principal aim is to find out if geriatric assessment data     can help to better predict for chemotherapy toxicity, loss of autonomy and survival. We plan     to accrue 360 patients diagnosed for cancer, including digestive, pulmonary, prostate,     lymphoma, bladder, ovary cancer for whom first-line chemotherapy is planned. Patients are     initially classified according to usual methods of medical oncology practice into three     groups: patients who can receive standard treatment, reduced standard treatment or treatment     adapted to the frail condition. Around Aquitaine, , we organised seven teams composed of one     geriatrician and one nurse. Two kind of teams were activated: one which cover ten treatment     sites in Bordeaux area and six sedentary teams which worked half a day a week in designated     hospitals . Geriatric evaluation included test of cognitive functions (MMS), nutritional     status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL;IADL), quality     of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening. Patients have four     geriatric evaluations : before treatment, day 1 cycle 2, day 1 cycle 4, day 1 cycle 7 and/or     end of chemotherapy. Since September 2002, 177 patients have been included, 112 have     finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3%     stopped because they were in progression and changed their treatment, 11.6% met     administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and     3.6% finished their treatment before. The following results have been obtained: before     treatment, 73% of these patients were at risk of undernutrition (MNA< 23.5), about 1/3 had     one or more inability or a risk of falls (38% IADL<6, 29% get up and go>20seconds, 27% ADL>1,     34% PS<1), 28% of them had altered cognitive functions (MMS<24), 29% were depressive     (GDS-15>6), 25% thought they had poor quality of life (QLQ-C30<4). Protocol will be closed in     September 2005.   "
180633|NCT00210262|"     Diabetes mellitus (DM) imposes a significant burden of early mortality and decreased quality     of life on the 6% of Canadians affected by it. There is a growing body of research evidence     showing that the use of certain medications (ACE inhibitors, blood pressure medications and     cholesterol lowering agents) can reduce the major complications of diabetes such as heart,     blood vessel and kidney disease and amputations. Unfortunately this research knowledge does     not appear to be routinely translated into clinical practice. The proposed study examines the     effect of simple mailed interventions to patients or physicians on improving the use of these     therapies. The strategies to be tested are direct patient education with an emphasis on blood     pressure and lipid control rather than use of particular drugs and, for physicians, the     provision of confidential prescribing feedback together with targeted educational bulletins.     With patient and physician consent, health care administrative data will be used to examine     the impact of the interventions. If successful, the study will identify low cost reproducible     interventions to promote the use of proven preventive therapies in clinical practice.   "
180634|NCT00210275|"     The purpose of this study is to determine whether printed educational materials can change     physician behaviour towards more evidence based decision-making.   "
180635|NCT00210288|"     The purpose of this study is to assess the immune response produced by two doses of SC599     vaccine compared to placebo.   "
180636|NCT00210301|"     MS has been associated with fatigue, attention problems, and a number of cognitive     difficulties. There is no treatment approved yet to treat these problems. We hypothesize that     the addition of Provigil to an existing immunomodulatory agent (Avonex) will lead to improved     fatigue, attention, and overall cognition in MS patients with attention problems.   "
180637|NCT00210314|"     Aim of the study is to establish in a prospective, randomized clinical trial the activity of     primary chemotherapy containing high dose-methotrexate, alone or combined with high dose     cytarabine, in patients with primary central nervous system lymphoma   "
180638|NCT00210327|"     The primary objective of this study is to assess the antitumor activity (in terms of overall     response rate - ORR - i.e. sum of complete and partial responses)of bortezomib in pretreated     MALT lymphomas with one prior sistemic therapy regimen   "
180640|NCT00210353|"     Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab     in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will     improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone.      In April 2006, a third arm of treatment was added to compare the antitumor activity and     safety of rituximab alone vs chlorambucil alone   "
180641|NCT00210366|"     The main objective of the trial is to assess the therapeutic activity of idarubicin as     salvage treatment in patients with recurrent or progressive lymphoma in the central nervous     system.   "
180642|NCT00210379|"     The primary objective assess the clinical activity of combination doxorubicin-containing     chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic     chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to     assess the toxicity of this therapeutic strategy   "
180643|NCT00210392|"     The primary objective of this study is to assess the antitumor activity (in terms of overall     response rate - ORR - i.e. sum of complete and partial responses) of bortezomib in pretreated     MALT lymphomas with more than one prior systemic therapy regimen   "
180644|NCT00210405|"     The objective of this study is to test the feasibility and effectiveness of distributing     micronutrient sprinkles to 6-20 month old children participating in an integrated maternal     and child health and nutrition program in rural Haiti. The micronutrient sprinkles have been     formulated to prevent or treat anemia in 6-23 month old children. Effectiveness in reducing     the prevalence of anemia will be assessed.   "
180645|NCT00210418|"     The objective of this study is to compare two approaches to targeting donated supplementary     food to young children. The study compares the effectiveness of the widely-used curative     approach where targeting is based on the child's poor nutritional status to a preventive     approach which targets children in poor communities solely on the basis of age and provides     supplementary food to all children aged 6-23 months. Cost-effectiveness of the two targeting     approaches will also be assessed.   "
180646|NCT00210431|"     The purpose of this study is to provide further information regarding the risks and benefits     of Dysport in marketed indications.   "
180647|NCT00210444|"     To evaluate the effect on healing rates of two different prognostic factors in patients     treated with Dysport® for anal fissure: duration of fissure and dose of study drug   "
180649|NCT00210470|"     IRX-2 is designed to activate your own body's immune system so that it can better fight the     invasion of head and neck cancer. In pre-clinical studies, IRX-2 has been shown to activate a     number of different cells of the immune system.      IRX-2 was previously tested in a study of 13 patients with advanced head and neck cancer who     had been previously treated and failed chemotherapy and/or radiation therapy. The trials were     specifically designed to test the safety of IRX-2. Researchers found that IRX-2 did not     appear to have major side effects. Also, the researchers believed that further study in less     advanced head and neck cancer patients could be useful in obtaining more data on the safety     of IRX-2 as well as data on possible effects on tumors and on patient survival.   "
180650|NCT00210483|"     The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate     (AXERT®) in treating acute migraine headaches in adolescents. Amotriptan malate (AXERT®) is     approved for use in the treatment of acute migraine headache with or without aura in adults.     In this study, adolescents will be given a single dose of study medication to treat one     migraine headache.   "
180651|NCT00210496|"     The purpose of this study is to evaluate the impact of topiramate (migraine prevention     medicine) on the effectiveness of almotriptan malate (acute migraine medicine) when treating     acute migraine headaches.   "
180652|NCT00210509|"     The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate     (AXERT®) 12.5 milligram tablets compared with placebo for the acute treatment of migraine     headache at the earliest onset of headache pain. Almotriptan malate (AXERT®) is approved for     the treatment of migraine headache, with or without aura, in adults. Patients in this study     will take either almotriptan or placebo oral tablets for 3 consecutive migraine headaches.   "
180653|NCT00210522|"     The purpose of this study is to evaluate the effectiveness and safety of the novel compound     RWJ-333369 in reducing the frequency of seizures in patients with epilepsy.   "
180654|NCT00210535|"     The primary purpose of this study is to evaluate the effectiveness and safety of topiramate     compared with placebo in the prevention of migraine attacks in children (12 to 17 years of     age).   "
180655|NCT00210548|"     The purpose of this study is to evaluate the effectiveness and safety of 3 doses of     paliperidone palmitate in treating subjects with schizophrenia.   "
180656|NCT00210561|"     The purpose of this study is to explore the pain-relieving effects and safety of Tramadol     HCl/acetaminophen as compared to placebo in patients experiencing acute low back pain.     Tramadol HCl/acetaminophen is approved for short-term management of acute pain. The     combination of tramadol HCl/acetaminophen has been shown to be effective for the treatment of     acute musculoskeletal pain. Patients who experienced at least moderate acute low back pain     for 2 to 10 days before study entry will be randomized to receive either tramadol     HCl/acetaminophen or placebo.   "
180657|NCT00210574|"     Limited data exist on the effectiveness of antiepileptic drugs for treatment of childhood     absence epilepsy. Preliminary data suggest that topiramate may be an effective drug for this     condition. The present study is designed to provide further evidence of the potential     effectiveness of topiramate for childhood absence epilepsy, as well as preliminary     information about a potential target dose for future study.   "
180658|NCT00210587|"     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa     (PROCRITÂ®) administered 80,000 Units every three weeks in cancer patients that are not     receiving chemotherapy or radiation therapy.   "
180659|NCT00210600|"     The purpose of this study is to evaluate the safety and efficacy of PROCRIT (Epoetin alfa)     when administered at 120,000 Units once every three weeks by comparing early dosing (Hb     11g/dL-12g/dL) vs. standard dosing (Hb< 11g/dL).   "
180664|NCT00210665|"     The purpose of this study is to facilitate access to trabectedin for eligible previously     treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from     currently available therapeutic options but who may benefit from treatment with trabectedin.     The safety profile of trabectedin will be evaluated to further assess the potential risks of     trabectedin treatment.   "
180665|NCT00210678|"     The purpose of the study is to characterize intravaginal ejaculatory latency time (time     between the start of vaginal intercourse and the start of intravaginal ejaculation) in men     with and without premature ejaculation (PE) and to assess the validity of patient-reported     outcomes.   "
180666|NCT00210691|"     The purpose of this study is to document the long-term safety and tolerability of     risperidone, formulated as a long-acting injectable, in the treatment of patients with     schizophrenia or schizoaffective disorder; in addition, to evaluate the long-term     effectiveness of long-acting risperidone and its effect on quality of life   "
180667|NCT00210704|"     The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal     ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).   "
180668|NCT00210717|"     The purpose of this study is to compare the effectiveness and safety over 1 year of treatment     of intramuscular injections of paliperidone palmitate and long-acting risperidone in patients     with schizophrenia.   "
180669|NCT00210730|"     The purpose of this study is to compare the efficacy of epoetin alfa (PROCRITÂ®) administered     subcutaneously (sc) once every week (qw) vs. no epoetin alfa (PROCRITÂ®) treatment in     patients with cancer who are anemic.   "
180670|NCT00210743|"     The purpose of this study is to evaluate the hemoglobin response rate in subjects with     anemia, associated with chronic kidney failure, after receiving epoetin alfa (PROCRITÂ®)     every 2 weeks   "
180671|NCT00210756|"     The purpose of this study is to describe the pharmacokinetics (PK) of six different dosing     regimens of epoetin alfa (PROCRITÂ®) in anemic critically ill subjects   "
180672|NCT00210769|"     The purpose of this study is to evaluate the long-term safety and tolerability and the     maintenance of effectiveness of a slow, extended-release oral formulation of paliperidone     administered once daily to patients diagnosed with schizophrenia.   "
180673|NCT00210782|"     The purpose of this study is to compare the effectiveness and safety of two treatment     regimens, topiramate as compared to phenytoin, in preventing seizures in patients with     new-onset epilepsy who require rapid initiation of antiepileptic drug therapy. Reasons for     requiring rapid initiation of treatment, rather than slowly increasing an antiepileptic drug     to an effective dose, may include severe or frequent seizures, or high risk to the patient of     recurrent seizures.   "
180674|NCT00210795|"     The purpose of this study is to assess changes in physical function in elderly patients (>=     65 years of age) with chronic anemia (Hb <= 11.0 g/dL) due to anemia of unknown cause and     receiving weekly subcutaneous doses of Epoetin alfa (PROCRITÂ®) versus placebo   "
180675|NCT00210808|"     The purpose of this study is to evaluate the safety and effectiveness of topiramate compared     to placebo in reducing the number of binge days in patients with moderate to severe     binge-eating disorder associated with obesity.   "
180676|NCT00210821|"     The purpose of this study is to compare the effectiveness and safety of two treatment     regimens in preventing migraines. The antidepressant amitriptyline has been used successfully     to prevent migraine headaches.   "
180677|NCT00210834|"     The primary objective of this study is to compare end of study hemoglobin levels between     Epoetin alfa at 40,000 units administered subcutaneously once every week and at 80,000 units     subcutaneously every two weeks in anemic patients with cancer receiving chemotherapy. The     secondary objectives of the study are to assess the Hb response, time to Hb response,     transfusion requirements, and safety.   "
180678|NCT00210847|"     The purpose of this study is to explore the pain-reieiving effects and safety of tramadol     HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic     neuropathy. Treatment of neuropathic pain often requires the use of more than one medication.     The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful     diabetic neuropathy comes from the multiple mechanisms of action in this combination pain     medication. Patients who experience painful diabetic neuropathy will be enrolled in this     study.   "
180679|NCT00210860|"     The purpose of this study is to assess the long-term safety and effectiveness of topiramate     for the prevention of migraine headaches in adults. Topiramate has been approved to prevent     migraine headaches in adults.   "
180680|NCT00210873|"     The purpose of this study is to assess the long-term safety and effectiveness of topiramate     for the prevention of headaches in adults with chronic migraine. Topiramate has been approved     to prevent migraine headaches.   "
180681|NCT00210886|"     The purpose of this study is to evaluate the effectiveness and safety of two antibiotics in     the treatment of complicated urinary tract infection or acute pyelonephritis (kidney     infection). A 5-day course of 750 milligrams of levofloxacin given intravenously and/or by     mouth once daily will be compared to a 10-day course of 400 milligrams of ciprofloxacin given     intravenously and/or 500 milligrams of ciprofloxacin given by mouth twice daily.   "
180682|NCT00210899|"     The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril     versus a comparator in the treatment of patients with complicated skin and skin structure     infections. The study will also characterize the safety and tolerability of treatment with     ceftobiprole medocaril in patients with complicated skin and skin structure infections.   "
180683|NCT00210912|"     The purpose of this study is to assess the safety and effectiveness of topiramate as compared     to placebo for the prevention of headaches in patients with chronic migraine. Topiramate has     been approved to prevent migraine headaches as well as in the treatment of epilepsy.   "
180684|NCT00210925|"     The purpose of this study is to evaluate the safety and effectiveness of topiramate compared     to placebo in patients with alcohol dependence.   "
180685|NCT00210938|"     The purpose of this study is to compare the clinical response rates of doripenem versus a     comparator antibiotic in treatment of hospitalized patients with complicated intra-abdominal     infections.   "
188773|NCT00327717|"     The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as     adjunctive therapy in medically refractory patients receiving other antiepileptic drugs     (AEDs).   "
180686|NCT00210951|"     The purpose of this study is to assess the incidence of pure red cell aplasia (PRCA     [suppression of erythropoiesis with little or no abnormality of leukocyte or platelet     production]) among participants with chronic renal failure (CRF), who were receiving     treatment with epoetin alfa or other exogenous recombinant erythropoietin therapies.   "
180687|NCT00210964|"     The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the     water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator     in the treatment of patients with nosocomial pneumonia.   "
180688|NCT00210977|"     The purpose of this study is to assess the presence of anti erythropoietin antibodies (anti     EPO Ab) in participants responding to any erythropoietin receptor agonist (ERA) therapy to     treat or prevent anemia without loss of effectiveness to see if they will develop pure red     cell aplasia or loss of effectiveness to recombinant erythropoietin and to measure the     duration of effectiveness of ERA therapy.   "
180689|NCT00210990|"     The purpose of this study is to assess the microbiological cure rate of doripenem in the     treatment of patients with complicated urinary tract infection or pyelonephritis. The study     will also characterize the safety and tolerability of treatment with doripenem in patients     with complicated urinary tract infection or pyelonephritis.   "
180690|NCT00211003|"     The purpose of this study is to compare the safety and effectiveness of doripenem in patients     with hospital-acquired pneumonia (HAP).   "
180691|NCT00211016|"     The purpose of this study is to compare the clinical response rate of doripenem versus     comparator in patients with ventilator-associated pneumonia (VAP).   "
180692|NCT00211029|"     The purpose of this study is to record the number of participants with chronic renal disease     who are receiving treatment with epoetin alfa or other recombinant erythropoietins who     develop pure red cell aplasia (PRCA, a rare form of anemia) during the study period.   "
180693|NCT00211042|"     The purpose of this study is to investigate the relationship of anti-erythropoietin     antibodies to the clinical course and outcome of pure red cell aplasia (PRCA) in participants     currently or previously treated with recombinant human erythropoietin.   "
180694|NCT00211055|"     The purpose of this study is to determine the incidence of anemia and blood transfusions and     management of these in critically ill children   "
180695|NCT00211068|"     The purpose of this study is to collect historical occurrences of risk factors that are     potentially associated with the development of anti-erythropoietin (EPO) antibody positive     pure red cell aplasia (PRCA) in participants with chronic kidney disease who have been     recently treated with epoetin alfa (EPREX).   "
180696|NCT00211081|"     Ultrasound is a technique that can provide images of the blood vessels such as arteries. The     size of the arteries, such as the main blood vessel in the arm, can change under different     conditions. Using ultrasound we can see how arteries change with movement or even drugs. We     want to use ultrasound to see how blood vessels look in patients with Congestive Heart     Failure (CHF) and to also see how a drug called Spironolactone, commonly prescribed for     patients with this disease, effects blood vessel function in patients with congestive heart     failure. This information may be used to change the standard of care for patients with heart     failure especially if we show that Spironolactone has a positive effect on vessel function in     patients with CHF.   "
180697|NCT00211094|"     The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal     ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).   "
180698|NCT00211107|"     The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal     ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).   "
180699|NCT00211120|"     The purpose of this study is to compare the outcomes of patients with chronic kidney disease     (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin     levels. This study will test the primary hypothesis that the level of anemia correction with     once weekly dosing of PROCRITÂ® (Epoetin alfa) in patients with chronic kidney disease will     decrease mortality and cardiovascular morbidity.   "
180700|NCT00211133|"     The purpose of this study is to evaluate the impact on survival and quality of life of     maintaining hemoglobin in the range of 12 to 14 g/dL using epoetin alfa or placebo in     patients starting chemotherapy for metastatic breast cancer for the first time.   "
180701|NCT00211146|"     This study is designed to investigate the incidence of deep vein thrombosis in patients     receiving a perisurgical regimen of epoetin alfa (PROCRITÂ®) as compared to patients     receiving standard of care blood conservation management.   "
180702|NCT00211159|"     Memory loss and difficulties with thinking associated with Alzheimer's disease (AD) may be     due to a deficiency in the brain of a fatty acid named DHA. The aim of this trial is to see     if dietary supplementation with a preparation, rich in DHA, will halt cognitive impairment in     AD patients   "
180703|NCT00211172|"     The primary goal of this study is to evaluate the effectiveness of direct-to-patient mailings     designed to increase patient's adherence to prescribed beta-blockers following an acute     myocardial infarction (AMI).      Prior to developing patient materials, focus groups were conducted with patient who had     previously suffered an acute myocardial infarction (AMI) to identify the issues and     information that patients felt were important to include in our materials as well as the best     way to present the information. Additionally, patient materials were pre-tested with AMI     patients to ensure that the materials were clear and easy to read and that the key messages     were understood.   "
180704|NCT00211185|"     Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral     T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study     will also compare what kind of side effects these drugs cause and how often they occur. The     hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK     + CHOP, will tolerate the treatment and will have a 20% improvement in response rate when     compared to CHOP alone.   "
180705|NCT00211198|"     The purpose of this research study is to evaluate how effective ONTAK is in the treatment of     cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein     called CD25 on the cancer cells makes a difference in how the body responds to the treatment.      The hypothesis is that there is no difference in response rate for patients whose tumor cells     are CD25 positive or negative.   "
180707|NCT00211224|"     NNIPPS is a clinical trial of riluzole (a drug previously shown to slow down the rate of     progression og amyotrophic lateral sclerosis-ALS; Lou Gehrig's disease) involving nearly 800     people diagnosed with the 'parkinson plus' syndromes of multiple system atrophy (MSA) and     progressive supranuclear plasy (PSP). In addition to showing whether riluzole is helpful in     MSA and PSP, NNIPPS will improve criteria for making an accurate and early diagnosis, for     assessing the rate of progression, and will advance understanding of the biology of these     disabling and progressive neurodegenerative diseases.   "
180708|NCT00211237|"     The primary objective of this study is to evaluate the safety and effectiveness of balloon     kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared     to standard non-surgical therapy in patients with cancer.   "
180709|NCT00211250|"     The purpose of this study is to compare compliance, tolerability, effectiveness, and     side-effects in Bipolar I and II patients switching from Valproic Acid to Depakote ER.   "
180710|NCT00211263|"     The Bipolar Disorder Center for Pennsylvanians aims to reduce significant differences in     treatment results among Pennsylvanians with bipolar disorder, especially among youth, the     elderly, rural residents, and African Americans who are less likely to receive adequate     treatment, less likely to remain in treatment once identified, and less likely to have     positive results if they remain in treatment. Half of the subjects receive either Guideline     Intervention (GI) or Enhanced Clinical Intervention (ECI). ECI is a combination of     information and support, such as education about bipolar disorder, the medications used to     treat it, information about sleep practices and habits that affect quality of sleep, review     of symptoms, medication side effects, and coping with side effects. It is predicted that     Enhanced Clinical Intervention will be more effective in reducing the differences in results     between those most at risk compared to mid-life Caucasians. The treatment study occurs at     three sites across Pennsylvania and has emphasized the recruitment of African Americans,     youth (ages 12 through 18), and adults over age 65.   "
180711|NCT00211276|"     The goal of this clinical research study is to find out if the study drug, ONTAK (denileukin     diftitox), can shrink or slow the growth of B-cell non-Hodgkin's lymphoma (NHL) in patients     whose disease has not responded to prior treatments, or has relapsed after an initial     response to prior treatments. The safety of treatment with ONTAK will also be studied. The     hypothesis is that patients with relapsed or refractory B-cell NHL and mild to moderate     myelosuppression treated with ONTAK at a new dosing regimen will respond sufficiently to     warrant further study.   "
188176|NCT00308334|"     The purpose of this study is to evaluate the effect of domperidone (given to lactating     mothers of very preterm infants) on the macronutrient composition of human milk.   "
180712|NCT00211289|"     The emphasis of this grant is to investigate ways to educate patients, not only to improve     their knowledge about medications and diet that are important for better outcomes in heart     failure, but also to try to understand how patients' beliefs about medication and diet affect     their behaviour and to what extent the investigators can help patients change.      Hypotheses: Heart failure patients who receive an enhanced educational intervention from     their community pharmacist will:        1. have an absolute risk reduction in the number of events of 20%,        2. be more compliant,        3. demonstrate less health-related quality of life (HRQoL) impairment as measured by          disease-specific and generic HRQoL instruments and        4. have lower costs/quality adjusted life years due to fewer total events per patient.   "
180713|NCT00211302|"     Evaluation of cognitive ability in patients with schizophrenia or schizoaffective disorder     both before and after a switch from risperidone to aripiprazole may reveal some of the     cognitive changes that correlate with the improved response, better side effect profile, and     effects on other components of the negative symptom array. Further, examination of brain     functional activity using functional magnetic resonance imaging (fMRI) during a verbal     learning task, as well as behavioral performance and associated electroencephalographic (EEG)     data of episodic memory, working memory and intermediate term verbal memory collected with     the Sustained Attention and Memory Brain Function Test (SAM-BFT), may also provide data     showing the neural correlates of these changes in cognition.   "
180714|NCT00211315|"     Congenital Telangiectasia or Coat's disease is an uncommon disorder that involves the growth     of blood vessels of the macula. These blood vessels msy extend beneth the retina to produce     an area of sub-retinal neovascularization(growth of abnormal blood vessels under the retina     which leak fluid, causing reduction in vision). Limited forms of treatment are available in     managing the neovascularization and its consequences. Anecortave Acetate injection will be     considered as an attempt to control the growth of the abnormal blood vessels.   "
180715|NCT00211328|"     Idiopathic Perifoveal telangiectasia is a poorly understood disorder that involves the growth     of blood vessels around the center of the macula(perifoveal region). These blood vessels may     extrend beneath the retina to produce an area of sub-retinal neosvascularization(growth of     abnormal blood vessels under the retina which leak fluid, causing reduction in vision.     Limited forms of treatment are available in managing the neovascularization and its     consequences. Anecortave Acetate injection is considered as an attempt to control the growth     of the abnormal blood vessels.   "
180716|NCT00211341|"     Main objectives: To evaluate the impact of weekly vitamin A supplementation (VAS) to women of     reproductive age (15-45 years) on maternal mortality in rural Ghana, and to compare this with     the impact on overall mortality.      Hypotheses:        1. Weekly supplementation with vitamin A (7000 µg retinol equivalent [RE]) to reproductive          age women will reduce maternal deaths by 33%.        2. This impact will be achieved by reductions in both pregnancy-related and          non-pregnancy-related deaths.        3. There will be a reduction in non-maternal deaths, similar in size to that in maternal          non-pregnancy related deaths.      Outcome measures: Maternal mortality rate, and overall mortality rate. Deaths will be     identified through monthly demographic surveillance, and classified as maternal     (pregnancy-related, non-pregnancy-related) or non-maternal using verbal autopsies.   "
180717|NCT00211354|"     Retinal Vein Occlusion is a blockage of the blood vessels that drain out of the retina.     Complications of retinal vein occlusion which threaten vision include     neovascularization(growth of new blood vessels)and macular edema ( accumulation of fluid     leaking from abnormal blood vessels). Currently, the treatment of retinal vein occlusion is     laser photocoagulation. This treatment has found to have limited use in this type of     condition.Anecortave Acetate is being considered as an attempt to control the growth of the     abnormal blood vessels.   "
180718|NCT00211367|"     Radiation retinopathy is a disease of the retina. It occurs in people who have received or     been exposed to radiation near the eyes. The blood vessels are abnormal and may grow which     lead to scarring and a loss of central vision. Currently, the treatment for radiation     retinopathy is laser photocoagulation. This treatment has been found to have limited use in     this type of condition. Compassionate use of anecortave acetate injection is being considered     to prevent the growth of the blood vessels under the retina.   "
180719|NCT00211380|"     This is the sister study to the BMS Cognitive Improvement with Aripiprazole (Abilify) study     (LSUHSC #H04-022). Evaluation of cognitive ability in patients with schizophrenia or     schizoaffective disorder both before and after a switch from risperidone, olanzapine, or     risperidone Consta injections to aripiprazole may reveal some of the cognitive changes that     correlate with the improved response, better side effect profile, and effects on other     components of the negative symptom array. Further, examination of brain functional activity     using functional magnetic resonance imaging (fMRI) during an episodic memory task, as well as     behavioral performance and associated electroencephalographic (EEG) data of working memory     and intermediate term verbal memory collected with the Sustained Attention and Memory Brain     Function Test (SAM-BFT), may also provide data showing the neural correlates of these changes     in cognition.   "
180720|NCT00211393|"     The purpose of this study is to determine the effect of an adrenocorticoid antagonist     (ketoconazole), 600 mg per day for 4 weeks, in the treatment of patients with central serous     chorioretinopathy (CSC).   "
180721|NCT00211406|"     The purpose of this study is to provide compassionate use of anecortave acetate sterile     suspension of 15 mg for a series of five patients as a means to control diabetic retinopathy.   "
180722|NCT00211419|"     The purpose of this study is to evaluate the safety of combining juxtasclerally administered     anecortave acetate 15 mg with triamcinolone acetate 4 mg administered intravitreally     following photodynamic therapy with verteporfin for the treatment of exudative age-related     macular degeneration (AMD).   "
180723|NCT00211432|"     The purpose of this study is to provide compassionate use of anecortave acetate sterile     suspension of 15 mg for a series of five patients as a means to control pseudovitelliform     detachment.   "
180768|NCT00185510|"     Purpose of the study:      One bothering feature of atopic dermatitis is its relapsing nature. Hence, it is worthwhile     to test modes how to efficiently prevent relapses or at least increase the time until the     disease recurs. In order to give recommendations to other patients, this study is to     scientifically describe efficacy and safety of a given regimen, namely a maintenance therapy     with two days a week Advantan.   "
180724|NCT00211445|"     Central serous choroidal (CSC) retinopathy is a disease of the macula characterized by     exudation of fluid under the retina localized to the posterior pole as well as loss of     vision. The etiology is unknown, but according to the studies this condition is more common     in young males and is associated with type A personality. Clinically, CSC is characterized by     serous retinal detachment and area of leakage of in the subretinal space. The standard of     care for acute CSC is observation for a period of up to 3 months. If there is no complete     resolution of the retinal detachment by 3 months, there is an indication for focal laser     photocoagulation therapy of the area of leakage. This treatment is usually effective in     stopping leakage of fluid under the retina and causing resolution of detachment. However,     laser photocoagulation therapy is not beneficial in the treatment of chronic CSC because     there is not a single easily identifiable point of leakage but rather diffuse disease of RPE     thus rendering laser treatment ineffective.The purpose of this medical research study is to     evaluate Verteporfin therapy as an approach which may benefit patients with CSC, based on     observations in exudative type of AMD patients treated with Photodynamic Therapy using     Verteporfin.   "
180725|NCT00211458|"     The purpose of this study is to provide compassionate use of anecortave acetate sterile     suspension of 15 mg for a series of five patients as a means to control classic     neovascularization following failure of treatment with photodynamic therapy using Visudyne.   "
180726|NCT00211471|"     To provide use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients     with rubeosis iridis. Rubeosis iridis refers to neovascularization of the iris. It is caused     by a number of conditions which include, but are not limited to severe diabetic retinopathy,     central retinal vein occlusion, chronic inflammation, and infection. Anecortave acetate is an     angiostatic, experimental drug that is being tested to prevent the growth of blood vessels     under the retina in patients with age-related macular degeneration (AMD). Therefore, it is     logical to apply the usage of Anecortave to patient’s with rubeosis iridis in order to reduce     the neovascularization stimulus and cause the regression of the abnormal iris vessels.   "
180727|NCT00211484|"     A compassionate method of treatment is offered to patients where lesions do not meet     acceptable criteria for standard therapy. Visudyne (Photodynamic Therapy) and laser     photocoagulation treatment (a treatment using heat from a fine point laser beam) have not     been found to be effective in treating the lesions these patients have.      Anecortave acetate is an experimental drug that is being tested to prevent the growth of     blood vessels under the retina in patients with age-related macular degeneration (AMD).   "
180728|NCT00211497|"     This is a Phase II, randomized, vehicle-controlled, double-blind, multi center study to     evaluate the efficacy and safety of topically applied MBI 226 1.25% and 2.5% Acne Solutions     as anti-acne preparations in human subjects with facial acne vulgaris.   "
180729|NCT00211510|"     The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm     722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control     when compared to subjects using the Paradigm 715 insulin pump only.   "
180730|NCT00211523|"     This study investigates the safety and efficacy of MBI 226 2.5% and 5.0% Acne Solutions,     applied topically for six weeks, in the treatment of acne.   "
180731|NCT00211536|"     The purpose of this study is to evaluate the effectiveness of insulin delivered in the     peritoneum (abdomen)by an implantable pump in Type 1 diabetics.   "
180732|NCT00211549|"     The purpose of this study is to identify the dose(s) of IDEA-033 that will provide a     meaningful effect for treating osteoarthritis of the knee.   "
180733|NCT00211562|"     This research study helps to demonstrate that adding vitamins and fats (nutritional     supplements) to a diet will help reduce body weight and improve the lipid profile. This will     be done by examining the body weight and chemicals in the blood. The chemicals are the result     of the brain using the fat that subjects eat in their diet. Some medications may also change     the amount of these chemicals in a person's blood.   "
180939|NCT00213863|"     This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to     adjust the quality of the voice under local or general anesthesia. The aim is to restore     phonation using a porous titanium prosthesis in laryngeal surgery.   "
180734|NCT00211575|"     This research study was designed to help improve the diagnosis and treatment of asthma in     young children. An interventional strategy using a scoring system based on risk factors and     symptoms/episodes was tested to determine its ability to identify children likely to benefit     from induction of asthma controller therapy at an early age. The score was derived through     completion of a survey instrument referred to as the asthma risk questionnaire (ARQ). The     utility of the ARQ along with the health care utilization and use of controller therapy for     respiratory illnesses within one year were examined.   "
180735|NCT00211588|"     The aim of the study is to determine whether galantamine stabilizes or improves thinking     abilities in individuals with Parkinson's disease. Individuals included in the study have     minor complaints about thinking such as problems with concentration or memory but do not have     dementia. This medication has been shown to have a positive effect on stabilizing memory in     individuals with Alzheimer's disease. It is FDA approved for use in elderly individuals with     Alzheimer's disease. It is hypothesized that galantamine will stabilize or improve executive     and attentional functions in individuals with Parkinson's.   "
180736|NCT00211601|"     The purpose of this study is to assess whether timely feedback to providers on patient     experiences with delayed chemotherapy induced nausea and vomiting (CINV) lead to differences     in patient outcomes for subsequent cycles.   "
180769|NCT00185523|"     The purpose of the study is to evaluate the overall and disease free survival of recipients     who have received G-CSF mobilized stem cells from HLA matched sibling donors.   "
180770|NCT00201786|"     This study will evaluate the response rate to treatment with pentostatin in     steroid-refractory acute graft versus host disease.   "
180771|NCT00201799|"     This study will evaluate the efficacy of infliximab in reducing the incidence of grade II-IV     acute graft versus host disease by day +100 post-transplant in patients undergoing allogeneic     hematopoietic stem cell transplant.   "
180772|NCT00201812|"     To determine the safety and efficacy of the combination of Etanercept and Docetaxel in     patients with advanced solid tumors for which there is no standard treatment.   "
180737|NCT00211614|"     Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working     middle-aged adults in the United States. Obesity is the number one risk factor for the     development of OSA. Consequences of untreated OSA are varied and significant and included     numerous neuropsychiatric parameters such as mood alterations, depression, anxiety,     diminished social interactions, and decreased quality of life. Mounting evidence suggests     that treatment of OSA can improve many of these outcomes. The primary treatment modality for     this condition is continuous positive airway pressure (CPAP). This device delivers positive     pressure to the upper airway in order to prevent its collapse during sleep. Unfortunately,     many patients do not choose to use CPAP or have difficulty with these devices. This results     in many individuals with OSA either going without therapy or unable to reap the full benefits     of treatment.      Gastroesophageal reflux (GERD) is also common in the United States and may, in some     instances, be directly related to weight gain. Survey studies have suggested that symptomatic     GERD is more common in patients with OSA. Whether there exists a cause and effect     relationship between these two conditions is not known at present. It has been suggested that     GERD may contribute to OSA by narrowing the upper airway.      This study will examine the effect of treatment of GERD on mild to moderate OSA. Fifty     individuals identified as having mild to moderate OSA (diagnosed by overnight sleep study or     PSG) and GERD (confirmed by an esophageal probe) will be enrolled. Both men and women will be     included in this study and no “special populations” will be utilized. Subjects will fill out     questionnaires to subjectively measure sleepiness, OSA-related symptoms, GERD-related     symptoms, and sleep apnea-related quality of life. They will then be randomized to receive     either 12 weeks of the proton pump inhibitor lansoprazole (Prevacid) or placebo (twenty five     subjects per group). Upon completion of the 12 week trial, subjects will return and the     following data will be collected; repeat all of the baseline questionnaires, repeat PSG and     repeat pH probe.      Results from this study will help to establish the relative effectiveness of a novel form of     therapy for a common yet difficult to manage medical condition. . The risks to subjects     enrolled in the study are minimal and therefore the benefit to risk ratio is heavily in favor     of performing the study.   "
180738|NCT00211627|"     Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to     treat simple snoring.   "
180739|NCT00211640|"     Male patients between the ages of 18 to 100 years of age who entered the Mid Michigan Health     Center were administered a patient demographic questionnaire, a Lower Urinary Tract Symptom     (LUTS) questionnaire, and the Men's Sexual Health Questionnaire (MSHQ) without exception. The     purpose of this study was to better identify symptoms of benign prostatic hyperplasia (BPH)     with the intent to prescribe better and more helpful treatment options for patients     demonstrating these symptoms.   "
180740|NCT00211653|"     The purpose of this study is to determine if Acetylcysteine is effective in preventing renal     failure associated with cardiac surgery   "
180741|NCT00211666|"     This hypertension project is evaluating strategies developed to target problems underlying     lack of blood pressure control among treated but uncontrolled hypertensive patients in East     and Central Harlem.   "
180742|NCT00211679|"     The purpose of this study is to determine whether intra-articular injection of botulinum     toxin is effective in the treatment of chronic knee paindue to arthritis.   "
180743|NCT00211692|"     Data have suggested that consensus interferon (CIFN) has greater antiviral activity in vitro     compared with interferon alfa-2a or alfa-2b. Several clinical studies also suggest that CIFN     has greater antiviral activity in patients with genotype 1 hepatitis C infection,     particularly if given as a daily injection. These data indicate that the use of a regimen of     daily CIFN and ribavirin will lead to greater virologic response rates compared with     pegylated interferon alfa-2b and ribavirin in patients with genotype 1 infection, with     comparable adverse events. Emerging data indicate that HCV genotype 1 patients with a delayed     virologic response to initial therapy may benefit from an extended duration of therapy.     Therefore, the goals of this pilot study are to determine the tolerability and efficacy of     daily CIFN plus ribavirin when given for 52 weeks or an extended duration of therapy. The     target population will consist of difficult-to-treat patients, defined as having the     following characteristics: genotype 1, a North American patient population, predominantly     male gender, and no specific exclusions for pre-existing psychiatric or substance abuse     co-morbidities.   "
180744|NCT00211705|"     To evaluate the primary preventive effect of low-dose pravastatin against coronary heart     disease (CHD) in Japanese hypercholesterolemic patients.   "
180745|NCT00211718|"     The purpose of this study is to determine whether intra-articular botulinum toxin type A is     effective in the treatment of chronic joint pain.   "
180746|NCT00211731|"     This study focuses on causes of under-use of secondary stroke preventive measures     demonstrated in randomized clinical trials to be efficacious, but not appropriately utilized     in urban, minority populations.   "
180747|NCT00211744|"     A 12-week program to examine the effectiveness of topiramate in adjunctive treatment for     adults with obsessive-compulsive disorder and who are currently on serotonin reuptake     inhibitor medications (ages 18-65).   "
180748|NCT00211757|"     The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs.     placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview     (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although     behavioral and educational therapies and a variety of medications may play a role in the     management of some autistic symptoms.   "
180981|NCT00214448|"     The objective of this study is to validate the performance characteristics of the GeneTrait     CGH Microarray System DX. Reproducibility among sites, lots, and operators will be evaluated.   "
180773|NCT00201825|"     This study will determine the objective response rate in chemotherapy naive non-small cell     lung cancer patients with advanced disease.   "
180774|NCT00201838|"     The aims of this protocol are:        1. To study the safety and tolerability of the combination of etanercept and gemcitabine in          patients with advanced pancreatic cancer:        2. To estimate the anti-tumor effect as measured by the proportion of patients free of          disease-progression at six months after treatment initiation.   "
180775|NCT00201851|"     This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different     times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510     premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at     hospitals in Philippines, Vietnam, and Morocco.   "
180776|NCT00201864|"     The purpose of this trial is to evaluate time to progression in women with hormone responsive     advanced breast cancer treated with a combination of exemestane and fulvestrant.   "
180777|NCT00201877|"     This study will determine the overall response rate and toxicity of rituximab and Velcade in     combination in patients with relapsed or refractory mantle cell non-Hodgkin's lymphoma.   "
188644|NCT00320697|"     This study seeks to determine if continued treatment with bupropion and nicotine replacement     therapy (NRT) can reduce the smoking relapse rate in patients with schizophrenia.   "
180749|NCT00211770|"     Autism, originally described by Kanner (1943), is among the most severe of neuropsychiatric     disorders. It is a pervasive developmental disorder affecting social, communicative, and     compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements,     craving for sameness, and narrow repetitive interests. Individuals with autism spectrum     disorders (ASD) are characteristically heterogeneous and show marked variability in their     response to interventions. Studies of behavioral and psychopharmacological interventions     document approximately 1/3 of ASD participants fail to respond to targeted treatments.     Efforts to evaluate the specificity of treatment effects are important to inform     conceptualizations about the disorder, identify behavioral phenotypes, and to aide clinical     decision making.      The goal of this study is to evaluate the use of clinical behavioral pharmacology methods,     functional behavioral assessments (FBA), in assessing the treatment effects of pediatric     medications in children with ASD. The present study of FBA procedures in pharmacological     treatment will be conducted as a separate, but parallel study within IRB approved, federally     funded, double-masked, placebo controlled medication trials of citalopram (GCO # 01-1295     PS*), an SSRI hypothesized to reduce stereotyped and repetitive behaviors in ASD and     divalproex sodium (GCO # 01-0294), a medication recently found to reduce repetitive behaviors     in ASD (Hollander et al., in press). This study will focus on the use of FBAs in     distinguishing responders vs. nonresponders on the basis of behavior function, in evaluating     functional patterns for stereotypy, aggression, and impulsivity, and in using descriptive     FBAs as outcome measures in clinical trials.      FBAs are behavioral assessment methods used to hypothesize about the function of maladaptive     behaviors. FBAs are conducted either through experimental manipulations known as functional     analyses or through descriptive analyses procedures, which involve structured observations     and parent/caregiver interviews. Descriptive analyses will be conducted with all participants     (n=24). The more rigorous, functional analyses will be conducted with a sub-set of the sample     (n=6) to corroborate the findings of the descriptive analyses. Data from the FBAs will be     collected using videotaped recordings of behavior and coded by trained raters for both the     descriptive and experimental analyses.      Our pilot data and other published data suggest that certain medications such as citalopram     (celexa) and divalproex sodium (Depakote) may improve global functioning in autistic patients     and repetitive/compulsive behaviors and social deficits. The addition of FBA methods to     evaluate outcome are an important step in extending the research and knowledge of the     conditions associated with good and poor treatment response to pediatric medications in     children with autism.   "
180750|NCT00211783|"     This study investigates face processing, response inhibition and phoneme processing in     autistic adults by fMRI.   "
180751|NCT00211796|"     12-week open label treatment trial of divalproex sodium extended release (Depakote ER) in 10     patients with a diagnosis of autism. Our objective is to determine how well these patients     can tolerate the prescribed doses and what added benefits can be attributed to divalproex     sodium ER.   "
180752|NCT00185250|"     Chronic viral cardiomyopathy is a disease where the cardiac muscle is attacked by a virus and     this may result in a reduction in the output of the heart (pump function) thereby causing     complaints such as chest pain, shortness of breath and palpitations.      Betaferon (interferon beta-1b) is marketed for the treatment of Multiple Sclerosis already,     but until now, it has not been proven whether it is also effective in patients with chronic     viral myocardial disease.      This study will be conducted to examine the efficacy and safety of Betaferon in patients with     this disease. The aim of the treatment is to eliminate the virus from the heart so that the     heart function and clinical status can gradually improve.   "
180753|NCT00185263|"     The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4     is effective in improving exercise capacity measured by exercise treadmill testing, angina     functional class, patient symptoms, quality of life, and cardiovascular outcomes. To doses     are to be studied, 2.87x10(8) and 2.87x10(9) viral particles, to evaluate the dose-response     of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.   "
180754|NCT00185276|"     The purpose of this study is to look at the safety (what are the side effects) and efficacy     (how well does it work) of Magnevist (the study drug) used for MRI of the infrarenal aorta     and peripheral arteries. The results will be compared to the results of MRI taken without     Magnevist, and with the results of your X-ray angiography.   "
180755|NCT00185289|"     The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic     preparation in the prevention of pregnancies in a large group of volunteers.   "
180756|NCT00185302|"     Primary objective: To evaluate the efficacy of two different dosing schedules of MS-275 in     subjects with metastatic melanoma Secondary objectives: To evaluate the safety and to assess     the pharmacokinetic profile of MS-275 in subjects with metastatic melanoma   "
180757|NCT00185315|"     The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol     inhalation therapy in patients suffering from pulmonary hypertension.   "
180758|NCT00185328|"     To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women     with hot flushes and other climacteric symptoms.   "
180759|NCT00185341|"     This study was designed as a proof-of-concept trial to evaluate safety, tolerability, and the     efficacy of 1800 mg (ZK 811752 600 mg given orally three times daily) over 12 weeks for the     treatment of endometriosis associated pelvic pain (EAPP) in comparison to placebo.   "
180760|NCT00185354|"     The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH     P00331F to a marketed comparator.   "
180761|NCT00185367|"     The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new     four-phasic oral contraceptive in comparison to a reference OC.   "
180762|NCT00185380|"     The purpose of this study is to investigate if drug doses lower than the one released from     Mirena® would be as effective for contraception as Mirena®. Subjects participating in the     study will be randomly assigned to be inserted with any of the three different intrauterine     systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from     them is different.   "
180763|NCT00185393|"     The aim of the study is to test [90]Y-ibritumomab tiuxetan, a radioactive antibody, in     patients with stage III or IV follicular lymphoma whose disease is in partial or complete     remission after first line chemotherapy. The radioactive antibody will be compared with no     further treatment to see which is better in the long term after standard lymphoma treatment.   "
180764|NCT00185419|"     The purpose of this study is to evaluate the effectiveness in terms of prevention of     pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in     healthy Chinese women   "
180765|NCT00185445|"     The purpose of the study is to demonstrate that oral fludarabine phosphate is comparable to     i.v. formulation used in combination with mitoxantrone in terms of efficacy, safety and     risk/benefit profile   "
180766|NCT00185458|"     The study has been designed to look at the transfer from using LNG IUS for contraception     only, in reproductive age to using it for endometrial protection in menopausal age. The main     area of interest in the study is the pattern of any vaginal bleeding that occurs.   "
180767|NCT00185484|"     The purpose of this study is to determine whether the study drug is effective in prevention     of pregnancy in healthy women in reproductive age   "
180778|NCT00201890|"     The purpose of this study is to evaluate the efficacy, safety and impact on quality of life     of decongestive lymphatic therapy (DLT) in women who have completed treatment for breast     cancer and present with lymphedema.      This is a multicentre trial enrolling 100 patients randomized to receive conservative care     for arm lymphedema (Canadian Guidelines) with or without decongestive lymphatic therapy     performed by a professional who has received training and certification in the technique of     lymphatic draining massage.      Duration: One year after the last patient is randomized.   "
180779|NCT00201903|"     To explore the relationship between tissue factor levels, tumour progression, activation of     blood coagulation and venous thromboembolism with malignant glioma   "
180780|NCT00201916|"     To improve the management of patients with early stage prostate cancer.   "
180781|NCT00201929|"     To enhance information transfer and decision making for women with breast cancer.   "
180782|NCT00201942|"     The overall goal of this study is to determine how FDG-PET can be incorporated into the     assessment of the axilla in the staging and treatment of women with early stage breast     cancer.      A multicentre, prospective, diagnostic accuracy study will be conducted evaluating the     ability of positronic emission tomography using fluorodeoxyglucose (FDG-PET) to detect the     presence or absence of axillary lymph node metastases in newly diagnosed breast cancer     patients with no clinical evidence of spread of disease beyond the breast.   "
180783|NCT00201955|"     The purpose of this study is to determine the potential safety and effectiveness of     rebamipide eye drops, an investigational eye drop being developed for the treatment of     keratoconjunctivitis sicca (dry eye).   "
180784|NCT00201968|"     The purpose of this study is to evaluate whether an aerobic and resistance training program     or a functional electrical stimulation-assisted Walking program is more effective for     reducing health complications related to spinal cord injury, for example, the occurrence of     bladder infections, pressure sores and/or frequency of spasms. It is hypothesized that the     functional electrical stimulation-assisted walking will have a greater impact on secondary     complications than the aerobic and resistance training program.   "
180785|NCT00201981|"     The purpose of this study is to determine the potential safety and effectiveness of     rebamipide eye drops, an investigational eye drop being developed for the treatment of     keratoconjunctivitis sicca (dry eye).   "
180786|NCT00201994|"     This study's purpose is to determine whether tolvaptan can safely and effectively return the     body's balance of sodium and water toward normal, and to characterize and quantify the     potential clinical benefits of this treatment.   "
180787|NCT00202007|"     This study design is subject to relevant SFDA regulations about clinical trials. Patients     will be screened for inclusion into the study at the initial visit(240 patients to be     recruited) and then undergo a minimum of 3-7 day’s placebo washout period(placebo wash out is     to eliminate the effect of prior antipsychotic medication with tablets without any active     ingredients)(patients without prior antipsychotic medication are exempt from the washout     phase). After screening and washout period, eligible patients will be randomly assigned to     the two treatment group, Aripiprazole or Risperidone, for 6 week’s treatment. Patients will     be hospitalized for the entire duration of the study. Patients’ condition will be assessed     weekly.   "
180814|NCT00211991|"     This study answers a U.S. Food and Drug Administration requirement for evaluation in people     of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three     lots of vaccine. The antibodies in the blood measure the immunogenicity of each lot of     vaccine, and typical vaccine safety information is also collected.   "
180815|NCT00212004|"     To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction in     patients with DM and old myocardial infarction   "
180816|NCT00212017|"     The purpose of this study is to evaluate whether an alpha-glucosidase inhibitor, a drug for     the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial     infarction in patients with impaired glucose tolerance (IGT) and old myocardial infarction.   "
180788|NCT00202020|"     The study design is subject to relevant SFDA regulations about clinical trials. This     indication was approved in Japan in 2003.      From the end of May 2004 to the end of Dec. 2004, 720 patients with previous cerebral     infarction(see the inclusion criteria) were enrolled in to the study and received one of the     two treatment regimens, Cilostazol or Aspirin, the ratio of patient number of each group is     1:1. For each patient, the chance of entering either of these two groups is the same. The     treatment will continue till the end of 2005. During the treatment period, patients will be     observed concerning some certain events, mainly reoccurrence of stroke. If the patient     experiences reoccurrence of stroke, or other event that the doctors think it is not     appropriate to continue the study medication, this patient would stop the treatment. Patients     were also required to take MRI head scan before entering the study and on completion of the     treatment.   "
180789|NCT00202033|"     To determine if the frequency of blood glucose testing in patients with type 2 diabetes who     are being treated with diet and exercise alone or diet and exercise plus oral agents will     impact the HbA1c level.   "
180790|NCT00202046|"     The purpose of this study evaluate which factors play a role in lymphedema development among     women who have had axillary surgery for breast cancer. Potential risk factors for women who     have developed lymphedema will be compared to risk factors among women who have not developed     lymphedema after breast cancer surgery.   "
180791|NCT00202059|"     The purpose of this study is to evaluate the effect of zoledronic acid and physical activity     on preventing bone loss in women aged 40 - 55 who are receiving chemotherapy for breast     cancer. The primary objective is to compare the percent change in the lumbar spine bone     mineral density (BMD) from baseline to 12 months for women who are randomized to either:     Group A) intravenous zoledronic acid, oral calcium carbonate, and vitamin D, or Group B) a     prescribed physical activity program, oral calcium carbonate and vitamin D.   "
180792|NCT00202072|"     The purpose of this study is to determine whether mucin is increased during pulmonay     exacerbations in adult patients with cystic fibrosis (CF).   "
180793|NCT00202098|"     The purpose of this study is to determine the effects of variable ventilation on respiratory     system of patients affected by acute respiratory distress syndrome.   "
180794|NCT00202111|"     The purpose of this study is to compare the short and long term outcomes of people who have     colon cancers removed either by laparotomy (a large cut in the abdominal wall) or by a     laparoscopic assisted approach (keyhole surgery). This study involves 37 credentialled     surgeons in 20 approved hospitals across Australasia and during the recruitment period (Jan     1998 to March 2005) 601 patients were recruited into the ALCCaS Trial.   "
180795|NCT00202124|"     The purpose of this study is to determine whether tryptophan is effective in the treatment of     mild to moderate Alzheimer's Disease (AD).   "
180796|NCT00202137|"     Hypertension is a common problem in Canada with a prevalence of about 15%. The goal of     hypertension therapy should be to maximize blood pressure control. Home blood pressure     monitoring (HBPM) devices are available and many patients are using them. The role that     self-monitoring of blood pressure can play in optimizing blood pressure control is unclear.     We hope to clarify the role of home blood pressure monitoring in the treatment of     hypertension and explore how it may affect patient and physician behaviours related to blood     pressure management. This study will compare a group of hypertensive patients who use HBPM     with those who do not use these devices. The intervention (HBPM) group will measure their     blood pressure at home a minimum of once weekly and will report these measurements to their     family doctor at each visit. The control group will receive usual care as delivered by their     family doctor. Outcomes of blood pressure control will be measured over a 12 month period.     Outcomes will be determined primarily by 24 hour ambulatory blood pressure monitoring and by     reviewing data in patient's charts located in family physicians office. Fifty family     physicians from the Kingston area have agreed to participate.   "
180797|NCT00202150|"     Patients living with advanced chronic diseases (ACD), such as congestive heart failure (CHF)     and chronic obstructive lung disease (COPD) present substantial care and economic challenges     for the health care system due to frequent emergency room visits and acute care     hospitalizations. Morbidity and mortality is high in these complex populations, and patient     quality of life is often compromised.      Care of patients with ACD occurs across health care sectors, by providers in the acute,     primary and community settings. Despite recent efforts to enhance the care of patients with     ACD, through multidisciplinary disease management programs, variations and gaps exist along     the continuum of care. The available evidence suggests that there are opportunities to     optimize the primary care of patients with ACD. We are proposing to build upon the current     evidence and guidelines for disease management programs, our existing specialized resources,     our existing primary care practices, and develop and test a model of care that is primary     care based, sensitive to the unique demands and characteristics of different primary     practices. Our goal is to design linkages and care strategies of relevance and importance to     the primary care providers who care for patients with advanced COPD and CHF.      This demonstration project is a randomized controlled clinical trial of the RoadMAP program     (intervention) delivered by a Primary Care Nurse Specialist (PCNS) compared to usual care     (control group). The primary outcomes will be degree of adherence to clinical practice     guidelines. Secondary outcomes will be patient satisfaction, quality of life, use of     community-based services, number of emergency room visits, and number of hospitalizations.   "
180798|NCT00202163|"     Androgen deficiency in the aging male is poorly understood. The objective of this study will     be to determine the role of testosterone and DHEA in enhancing sexual interest and sexual     performance.   "
180799|NCT00202176|"     In people with mild COPD, the ability to exhale air from the lungs is partly limited because     of narrowing and collapse of the airways. This results in the trapping of air within the     lungs and over-distention of the lungs and chest (lung hyperinflation).      Breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort     (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or     breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing     as this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can     be taken orally, through injection or through inhalation and begin to act almost immediately     but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the     effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients     with mild COPD.   "
180800|NCT00202189|"     Human and animal studies have shown that inhaled corticosteroids (ICS) decrease airway blood     flow . This effect is immediate (within 30 minutes), transient (lasting 90 minutes), and in     animal studies independent of gene expression. In COPD patients, decrease in bronchial blood     flow may also decrease mucosal edema, airway resistance and improve small airway function. If     such an effect exists, then we should be able to measure improvements in airway conductance     and reduce lung hyperinflation, which would have salutary effects on dyspnea and exercise     endurance.      To our knowledge, no study has examined the immediate effect of ICS on small airway function     in COPD. The purpose of this study is to examine the effects of nebulized Pulmicort on small     airway function (spirometry, plethysmographic lung volumes, airways resistance, closing     volume, partial flow-volume loop analysis) and exercise endurance in patients with moderate     to severe COPD.      HYPOTHESIS        1. Nebulized ICS will immediately improve airway function compared with placebo (nebulized          saline).        2. Enhanced lung emptying and reduced operating lung volumes during rest and exercise          following ICS therapy will translate acutely into clinically important reductions in          exertional dyspnea and improvements in exercise endurance.   "
180801|NCT00211809|"     The research project is a controlled pilot study of the efficacy of cognitive-behavioral     therapy (CBT) as an adjunct to serotonin reuptake inhibitor (SRI) pharmacotherapy in body     dysmorphic disorder (BDD). This study assesses the efficacy of CBT in comparison to     relaxation and stress management training (RSMT), an active control treatment   "
180802|NCT00211822|"     This study will explore the brain processes associated with inhibition and reward processing     in pathological gamblers and people with obsessive compulsive disorder compared to healthy     controls.   "
180803|NCT00211835|"     Randomized clinical trial that compares the effects of cognitive behavioral therapy (CBT) and     supportive psychotherapy for depression. Short- and long-term outcomes will be evaluated in     terms of changes in mood (primarily depression and anxiety), participation in activities and     life satisfaction.   "
181773|NCT00223964|"     This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal     guardian had provided signed informed consent and satisfied the inclusion and exclusion     criteria.   "
180804|NCT00211848|"     The primary aim of this investigation is to evaluate the effect of a combined antiviral,     antifibrotic and antioxidant treatment on the progression of liver disease in patients with     hepatitis C who either abstain from alcohol or continue to drink. All subjects are given     state-of-the-art antiviral treatment (pegylated interferon + ribavirin), supplemented with     either placebo or polyenylphosphatidylcholine (PPC), a purified soybean extract consisting of     95-96% polyunsaturated phosphatidylcholines (PC) and which has both antifibrotic and     antioxidant properties. Secondary aims are to verify whether moderate alcohol consumption     interferes with the antiviral effect of pegylated interferon + ribavirin on HCV and to     validate the reliability of various circulating markers as substitute for liver biopsies to     indicate the stage of liver pathology and its propensity for progression.   "
180805|NCT00211874|"     For congestive heart failure (CHF) patients with systolic dysfunction, a randomized     controlled trial compared nurse-based disease management to address problems in patient and     clinician management with usual care for effects on hospitalization and functioning among     ethnically-diverse patients in ambulatory practices.   "
180806|NCT00211887|"     This is for a randomized clinical trial (RCT) to determine if the combined use of interferon     beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent     used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).   "
180807|NCT00211900|"     This study answers a U.S. Food and Drug Administration requirement for evaluation in people     of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The     antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety     information is also collected.   "
180808|NCT00211913|"     S. aureus is the most common pathogen encountered in infection associated with cardiovascular     surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified     capsular polysaccharides (CPS) that have been implicated as a major factor in the     invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to     surgery could provide sufficient antibody concentrations during surgery and during the wound     healing period so as to decrease the risk of S. aureus infection. This study aims to     demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are     candidates for cardiovascular surgery.   "
180809|NCT00211926|"     S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a     vaccine to prevent these infections, which conjugates the purified capsular polysaccharides     of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This     study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in     patients who are candidates for knee or hip arthroplasty.   "
180810|NCT00211939|"     The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and     sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive     technique, electron beam computed tomography (CT) scanning, to measure calcium in the     coronary arteries, the aortic valve, and the mitral valve.   "
180811|NCT00211952|"     The aim of the study is to assess the influence of celecoxib on relapse-free survival in     completely resected patients with poor prognosis indicated by metastatic involvement of     intrapulmonary/hilar (pN1) or ipsilateral mediastinal (pN2) lymph nodes. Celecoxib, a     selective oral COX-2 inhibitor, was found to exert significant anti-proliferative activity     against a variety of tumor cell lines in vitro, including NSCLC. COX-2 is frequently     up-regulated in NSCLC cell lines and archival tumor samples. Its high expression was also     correlated with poor prognosis of the patients. A clinical trial addressing the role of     celecoxib as adjuvant treatment in radically operated patients with high risk of relapse is     warranted.   "
180812|NCT00211965|"     Staphylococcus aureus (S. aureus) is the most common pathogen encountered in infections     associated with orthopedic surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine     which contains the purified capsular polysaccharides that have been implicated as a major     factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus     prior to surgery could provide sufficient antibody concentrations during surgery and the     wound healing period so as to decrease the risk of S. aureus infection. This study aims to     demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are     candidates for orthopedic surgery.   "
180817|NCT00212030|"     To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct     size and improves regional wall motion   "
180820|NCT00212069|"     Tumors are heterogeneous with varying response to chemotherapeutic agents. We hypothesize     that tumors that are sensitive to a particular chemotherapeutic agent have a distinctive     tumor protein profile compared to those that are resistant. We further hypothesize that since     tumor is continuously perfused by serum, serum protein profile can be used as a surrogate     marker of tumor protein profile. The primary objective of this study is to identify a serum     protein profile that predicts gemcitabine/carboplatin sensitivity or resistance in breast     cancer patients with prior exposure to anthracyclines and taxanes. Secondary objectives are     to establish the serum protein profile of breast cancer patients who have had prior exposure     to anthracyclines and taxanes, and to study the pharmacogenetics of gemcitabine toxicity by     correlating germline genotype of transporters and drug metabolizing enzymes with plasma and     intracellular gemcitabine pharmacokinetics.   "
180821|NCT00212082|"     We hypothesize that changes in tumor gene expression profiles vary in response to different     sequences and types of chemotherapy, and that gene expression changes will correlate with     tumor response. We are also looking to correlate drug pharmacokinetics and treatment toxicity     with genotype of drug metabolizing enzymes and tranporters.Patients with metastatic breast     cancer and who have measurable primary breast tumor will be randomized to one of two     alternating sequences of adriamycin and docetaxel. Serial tumor biopsies and plasma samples     will be obtained for gene expression and proteomic studies to identify biomarkers that will     predict for chemotherapy response.   "
180822|NCT00212095|"     Patients with locally advanced or metastatic breast cancer and with measurable primary breast     tumor will be treated with 70mg docetaxel combined with ketoconazole. Serial tumor biopsies     and plasma samples will be taken for gene expression and proteomics studies to identify     biomarkers that may predict for treatment response.   "
181774|NCT00223977|"     This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and     provide signed informed consent will be randomized to receive one of two levels of Ferrlecit     or oral iron in a 1:1:1 ratio.   "
180823|NCT00212108|"     EGFR and COX-2 are involved in tumorigenesis, angiogenesis and metastases and are frequently     over expressed in NPC.COX-2 and EGFR inhibitors are active in NPC.There is synergistic action     between COX-2 and EGFR inhibitors.      Study hypothesis: Celecoxib and gefitinib can reduce angiogenesis and induce     anti-tumorigenicity in patients with nasopharngeal cancer.   "
180824|NCT00212121|"     hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control     at 10 years from 88% to 93%, with still acceptable cosmesis.   "
180825|NCT00212134|"     The primary purpose is to determine whether infants with a unilateral congenital cataract are     more likely to develop better vision following cataract extraction surgery if they undergo     primary implantation of an intraocular lens or if they are treated primarily with a contact     lens. In addition, the study will compare the occurrence of postoperative complications and     the degree of parental stress between the two treatments.   "
180826|NCT00212147|"     Low cobalamin (vitamin B12) levels are frequent in the elderly. Most often they reflect a     mild metabolic abnormality without clinical symptoms (subclinical cobalamin deficiency). It     is unclear if these elderly people require medical intervention, unlike that small minority     with clinical symptoms which can progress and create severe blood or nervous system problems.     The study aims to determine if nitrous oxide (N2O), a common anesthetic agent, worsens     cobalamin status in elderly patients with unrecognized subclinical cobalamin deficiency. The     reason for concern is that N2O inactivates cobalamin and can aggravate the clinical picture     of patients who already have clinical manifestations of cobalamin deficiency. The elderly are     known to have an increased risk of developing mental changes after surgery and it may be that     sometimes these result from aggravation of subclinical cobalamin deficiency.      The study recruits people over the age of 60 years who are undergoing clinically indicated     elective surgery requiring general anesthesia for more than 1 hour. Patients meeting     exclusion and inclusion criteria are randomized to receive either a standard anesthetic     regimen that includes N2O or a nearly identical one without N2O. Before surgery and 2 weeks     and 4 weeks after surgery, each patient undergoes (1) a broad battery of tests of cognition     and mood and (2) blood tests measuring cobalamin, folate and homocysteine-methionine     metabolism to determine whether they have any subtle biochemical impairment of cobalamin     status. DNA from blood cells is also tested for the presence of common mutations that affect     key enzymes in those metabolic pathways. A brief testing for postoperative delirium is also     done 2 hours after surgery.      The patient subgroups' are analyzed for neuropsychologic changes over time, using the     preoperative test as the baseline for all comparisons, and associations of those changes with     metabolic, genetic, demographic and clinical data.      The primary question is what effect routine N2O exposure has on the latter compared with     non-N2O anesthesia in elderly people who either have or do not have subclinical cobalamin     deficiency. It will help answer whether or not the combination can help explain the increased     risk of cognitive problems after surgery in elderly patients, and by extension whether     preoperative cobalamin testing and treatment may be indicated in the elderly. It will also     test whether genetic predisposition affects the described problems.   "
180827|NCT00212381|"     To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable     based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical     dysplasia in otherwise healthy women.   "
180828|NCT00212394|"     The purpose of the study is to establish the number and nature of complications that we, the     researchers, have with the use of a tourniquet in orthopaedic surgery in Norway.   "
180829|NCT00212407|"     Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow     reconstitution in patients who would be potential candidates for a bone marrow transplant     from an unrelated marrow donor. The outcome of transplantation is obtained to assess cord     blood myeloid and platelet engraftment, transplant related mortality, overall survival, graft     vs. host disease and, for patients with leukemia, lymphoma or myelodysplasia, relapse.   "
180830|NCT00212420|"     To Investigate whether different routes of nutrition affect the probability of fistula     closure in patients with an enterocutaneous fistula   "
180831|NCT00212433|"     To ascertain which of four combinations of low residue diet, reduced laxative dose and oral     contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT     colonography   "
180832|NCT00212446|"     Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart     pacemaker to deliver a weak electrical current to the human uterus that will rapidly and     safely inhibit the unwanted premature uterine contractions of preterm birth.   "
180833|NCT00212459|"     The study will see if counselling adolescents with severe or moderate Hemophilia A or B     results in increased compliance in the maintenance of bleeding logs.   "
180834|NCT00212472|"     The purpose of this study is to see if a low-dose arm or a high dose-arm of immune tolerance     is more effective in eliminating inhibitors in patients with hemophilia A.   "
180835|NCT00212485|"     The purpose of this study is to see whether power Doppler sonography (PDS) can be used to     diagnose synovitis in patients with inherited bleeding disorders.   "
180836|NCT00212498|"     To create a Tuberculosis Research Blood Bank for future molecular genetics and serological     studies   "
180837|NCT00212511|"     The purpose of this study is to create a database of demographics and samples in idiopathic     pulmonary fibrosis.   "
180840|NCT00212576|"     This project will measure the degree to which parenting programs based in pediatric primary     care can be effective in promoting language development and school readiness in at-risk young     children.      The study is a randomized controlled trial in which two different primary care-based     parenting programs will be compared to a control group in a population that is at risk on the     basis of poverty. The two programs represent varying levels of low intensity, but each has     the same goals: enhancing parent-child interaction in order to improve language, cognitive     and social-emotional development and ultimately promote school readiness and school     performance.      One program is called the Video Interaction Project. While waiting to see the primary care     provider for well child care, the family meets with a child development specialist, who     videotapes the parent and infant interacting together. The videotape is then rewound and     watched together by the parent (and infant!) and child development specialist. This leads to     a discussion about child development, infant cues and parenting, with the child development     specialist building on observed strengths in the interaction. In addition, families are     provided with parenting pamphlets developed for the project, and with inexpensive     developmentally stimulating toys.      The other program is called the ASQ-Building Blocks Project. This project employs a public     health approach to facilitate parental engagement in child development. Families are sent     monthly newsletters that focus on child development, infant cues and parenting; included with     each newsletter is an inexpensive, developmentally stimulating toy. In addition, families     periodically receive Ages and Stages Questionnaires, which they complete and mail back to the     program. Based on the questionnaires, the program determines whether the infant has screened     positive for possible developmental delay and provides this information to both the family     and the primary care provider.      This study will test 2 hypotheses:        1. Primary care based parenting interventions can impact parent-child interaction, early          child development and school readiness.        2. Interventions of differing intensity will have impacts of differing magnitude depending          on the risk level of the family.   "
180887|NCT00213187|"     The objectives of this study are to study the effect of formal exercise training on motor     function and overall physical fitness in children with arthritis. A 12-week comprehensive     exercise program will be used. Formal exercise training will be compared to Qi gong.   "
180888|NCT00213200|"     This study will test which type of pain medication is best for the management of pain in     newborn preterm and full-term infants having a deep intravenous cannula inserted. It will     compare the effectiveness of intravenous morphine alone, a local anaesthetic cream     (amethocaine) alone, and both medications together. It will also determine the safety of both     medications.   "
180841|NCT00212589|"     Until recently, bolus 5-flourouracil (FU) + folinic acid (FA) has been considered the     standard chemotherapy for patients with colorectal cancer. Several studies have shown that     Capecitabine is as effective as Mayo regimen. The Nordic FU/FA schedule was developed to be     an active and tolerable bolus regimen. The Nordic regimen consists of a short (3 minutes)     bolus injection of FU and 30 minutes later FA for 2 consecutive days each 2 weeks. In     randomized studies efficacy is comparable to other FU/FA regimens.      It is claimed that patients prefer oral therapy and in a randomized study comparing oral     therapy (UFT/FA) and bolus FU/FA (Mayo) 84% preferred oral therapy.      In the present randomized cross-over study patients were randomized for 3 courses of Nordic     FU/FA followed by 2 courses of Capecitabine (or vice versa), and patients were asked for     their preference.   "
180842|NCT00212602|"     The purpose of this study is to examine the efficacy and safety of ONO-7436 for the     prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant     tumor   "
180843|NCT00212615|"     XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with     metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be     randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the     evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or     chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening     days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).      Bloodsamples will be collected and frozen and later examined for potential predictive factors   "
180844|NCT00212628|"     The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with     involutional osteoporosis.   "
180845|NCT00212641|"     The objectives of this study are to characterize the pharmacodynamic profile, safety and     tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus   "
180846|NCT00212654|"     The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in postoperative     supraventricular tachyarrhythmias.   "
180847|NCT00212667|"     The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with     involutional osteoporosis.   "
180848|NCT00212680|"     The purpose of this study was to evaluate the dose-dependent effects of ONO-1101 on efficacy     and safety in patients with postoperative supraventricular tachyarrhythmias.   "
180849|NCT00212693|"     The purpose of this study is to evaluate the efficacy and safety of ONO-2506PO in patients     with Parkinson's Disease   "
180850|NCT00212706|"     The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in     patients with overactive bladder.   "
180851|NCT00212719|"     The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with     involutional osteoporosis.   "
180852|NCT00212732|"     The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in     patients with overactive bladder.   "
180853|NCT00212745|"     The purpose of this research study is to see if a behavioral program which includes a     relaxation technique and lifestyle changes can improve seizure control and well-being in     epilepsy patients.   "
180854|NCT00212758|"     Treatment with growth hormone (GH; a hormone made by the body that stimulates growth) has     been shown to be helpful in treating children with chronic kidney disease who fail to grow.     The amount of growth that is seen in children treated with growth hormone varies widely for     unknown reasons. Growth hormone works by producing another hormone in the liver called     insulin-like growth factor-1, or IGF-1 for short. IGF-1 stimulates the bones to grow. The     amount of IGF-1 in the blood may directly affect the amount of growth in each child. At this     time, growth hormone therapy in children depends on giving a certain dose of growth hormone     for each child based on his or her weight. If after 3-6 months on this dose of growth hormone     the change in height is not enough, then the dose of growth hormone is increased until enough     growth is seen. This method of dosing of growth hormone may take a long time and is     complicated and time-consuming.      The purpose of this study is to measure the amount of IGF-1 produced by the body as a result     of giving 2 different doses of growth hormone in children for 7 days only. The study     investigator hopes to find the most favorable level of IGF-1 generated after 7 days of growth     hormone that correlates with good growth of children with kidney disease. Then instead of     dosing growth hormone by weight, like is done now, researchers can dose growth hormone by the     amount of IGF-1 that the body produces. Being able to dose more effectively will save     valuable time for the child to grow and will shorten the overall duration of growth hormone     therapy.      The investigators will also determine the effect of inflammatory cytokines Il-6 and TNF-alpha     on growth hormone insensitivity and hence IGF-1 generation test in the same population.   "
180886|NCT00213174|"     This study will compare children's injury rates (arm fracture, head injury and other     injuries) when playing on playground equipment on granite sand versus wood fibre playing     surfaces.      The hypothesis is that injury rates (arm fracture, head injury and other injuries) among     school children are equal on granite sand and wood fibre playground surfaces.   "
188774|NCT00327730|"     The purpose of this study is to evaluate the efficacy of Eperisone HCl in the treatment of     Acute Musculoskeletal spasm associated with Low-Back Pain.   "
180855|NCT00212771|"     The primary features of schizophrenia and schizoaffective disorder are positive (inability to     think clearly and distinguish reality from fantasy) and negative symptoms (reduction or     absence of normal behavior or emotions). Other symptoms include reduced ability to recall and     learn information, difficulty in problem solving maintaining productive employment.      Asenapine is an investigational drug that may help to correct the above schizophrenia by     altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term     extension trial to further test the efficacy and safety asenapine and a comparator agent     (olanzapine) in the treatment of patients with schizophrenia.   "
180889|NCT00213213|"     This study will examine the safety and effectiveness of sugar water to relieve pain in     newborn infants during painful blood tests and injections. Infants of diabetic mothers who     receive repeated blood tests will be compared to infants of healthy mothers who receive     routine painful procedures.      We believe that administration of sucrose analgesia for every painful cutaneous procedure     performed after delivery will result in less pain during the newborn infant screening test.   "
180856|NCT00212784|"     The primary features of schizophrenia and schizoaffective disorder are characterized by     positive (inability to think clearly and distinguish reality from fantasy) and negative     symptoms (reduction or absence of normal behavior or emotions). Other symptoms include     reduced ability to recall and learn information, difficulty in problem solving or maintaining     productive employment. Asenapine is an investigational drug that may help to correct the     above characteristics of schizophrenia by altering the inbalance of brain hormones such as     dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of     asenapine using an active comparator (olanzapine) in the treatment of patients with     schizophrenia. Patients who complete the 12-month trial will have the option of continuing on     drug until the treatment code for the 12-month trial is unblinded.   "
180857|NCT00212797|"     The primary purpose of this study is to determine whether subjects with psychotic major     depression benefit from adjunctive treatment with Org 34517. Two doses of Org 34517 will be     compared to placebo in this international multicenter study. The duration of this trial is 6     weeks.   "
180858|NCT00212810|"     The purpose of this study is to determine whether Topiramate is effective in preventing the     development of chronic daily headache among patients with episodic migraine headaches.   "
180859|NCT00212823|"     The purpose of this study is to evaluate the effectiveness and safety of AXERT when treating     a migraine at the onset of headache pain, as compared to treating a migraine only after the     headache pain has reached at least moderate intensity..   "
180860|NCT00212836|"     Treatment with conventional antipsychotics such as haloperidol has little effect or may     sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and     poor rapport) of schizophrenia. The newer atypical antipsychotics agents, such as     olanzapine, have shown improvement in the treatment of negative symptoms in acute trials. The     purpose of this study is to compare an investigational compound (asenapine) with a marketed     agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of     schizophrenia for 6 months. Patients completing this study may be eligible to participate in     an extension 6 months of treatment. Patients are required to have stable symptoms prior to     entry into study.   "
180861|NCT00212849|"     The purpose of this study is to measure the outcomes of patients who have articular cartilage     lesions in the patellofemoral joint and are treated with the Autologous Chondrocyte     Implantation.   "
180862|NCT00212862|"     The purpose of this study is to describe patient characteristics, treatment patterns, and     clinical outcomes in adult patients with cancer who are receiving erythropoiesis-stimulating     therapy (EST).   "
180863|NCT00212875|"     The primary objective of this study is to compare the change in hemoglobin (Hb) from study     start to the end of the study between the every 2 week and the every 4 week dosing regimens     in patients with anemia of chronic kidney disease (CKD) initiated on PROCRIT (epoetin alfa).     Protocol Addendum: The primary objective of the open-label extension portion of this study is     to evaluate if epoetin alfa 40,000 Units given under the skin every six weeks, can maintain     hemoglobin within the range of 11-12 g/dL in patients with anemia of CKD.   "
180864|NCT00212888|"     The purpose of this study is to determine if vaccination before a structured treatment     interruption (STI) is associated with an improvement in immune function, resulting in a     delayed and reduced rebound in the amount of HIV virus in the blood.   "
180865|NCT00212901|"     Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to     recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective     in decreasing amount of protein in urine in patients with diabetic kidney disease than high     doses of trandolapril.   "
180866|NCT00212914|"     In 1998, The Canadian Diabetes Association published guidelines that recommended women     diagnosed with gestational diabetes mellitus (GDM,) should be screened postpartum for Type 2     diabetes using a glucose tolerance test. We determined the rate of screening for Type 2     diabetes at the Ottawa Hospital before and after the publication of this guideline and found     that none of the women in either period had been screened following this recommendation. We     believe a reminder letter outlining the recommended screening test sent to the patient and/or     her family physician would increase screening for Type 2 diabetes in women with previous GDM.   "
180867|NCT00212927|"     1. INTRODUCTION: Continuity of care (COC) occurs when separate elements of patient care are     connected. COC is made up primarily of Continuity of Provider (COP) and Continuity of     Information (COI). Many authorities believe that COC is essential to high-quality care.     Previous studies have shown poor COC in varied populations. Many studies have shown that     increased COC has been associated with improved intermediate outcomes. However, no study has     definitively determined whether COC or either of its components is associated with important     outcomes. The Ontario-Outcomes After the Hospitalization (Ontario-OAtH) study will enroll     5900 adults who are discharged to the community from medical and surgical services from 13     teaching and community hospitals in 5 regions across Ontario. Patients will be followed for 6     months to record details about all interactions with the health care system. This information     will give us a detailed measure of both provider and information continuity for all patients     over time. The Ontario-OAtH study will have the power to precisely determine whether COC is     associated with time to urgent readmission or death after hospital discharge. Since COC is     potentially modifiable, the Ontario-OAtH study will give us essential information required     for designing interventions to improve outcomes for patients after they are discharged from     hospital.   "
180868|NCT00212940|"     The purpose of this study is to determine whether a psycho-educational intervention can help     people living with HIV handle the changes of treatment adherence.   "
180869|NCT00212953|"     The purpose of the study is to evaluate the incremental benefit of a full advanced life     support EMS program on the outcomes of chest pain, respiratory and major trauma patients.   "
180890|NCT00213226|"     This study is to determine the effectiveness of five-day treatment versus a single dose of     oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first     episode of acute bronchiolitis presenting in the Emergency Department   "
180891|NCT00213239|"     This study will examine whether the combination of two anaesthetic medications, propofol and     remifentanil, is suitable for short duration surgical procedures, providing a shorter     recovery time and fewer side effects than either drug used alone.   "
180871|NCT00212979|"     Kidney transplantation is the preferred treatment for permanent kidney failure. Following     transplantation, the kidney function must be followed closely to detect problems so that     investigations and appropriate treatment can be started early. Currently, function is     monitored with the use of serum creatinine. In clinical trials involving kidney transplant     recipients, markers of kidney function, such as serum creatinine, are increasingly being used     as outcomes to evaluate new treatments. However, serum creatinine is not very accurate or     sensitive at detecting change in kidney transplant function. Newer methods of evaluating     kidney function, such as the Modification of Diet in Renal Disease (MDRD) equation and     cystatin C, are known to be accurate markers of function in patients with non-transplant     kidney disease. This study will compare the MDRD estimate and cystatin C estimate of kidney     function with an accepted method (radioisotope clearance study) of measuring true kidney     function in 250 renal transplant patients. Each patient will have 2 measurements made at     least 3 months apart to determine the accuracy and responsiveness to change over time for the     MDRD equation and cystatin C. If the results demonstrate that these new methods are accurate     then clinical care and research studies involving transplant patients will be greatly     enhanced. Patients and physicians would have a simple test that could detect problems earlier     and more precisely monitor response to treatment leading to improved outcomes for renal     transplant recipients.   "
180872|NCT00212992|"     This study will compare the effect of constant low-level energy [150 joules] to an escalating     energy [200-300-360 joules] regimen of biphasic waveform defibrillation on multiple patient     outcomes.   "
180873|NCT00213005|"     The study objectives were to assess the mucosal safety of Carraguard® gel when applied     vaginally once per day for 14 days by sexually abstinent and sexually active, HIV-positive     women; to evaluate the effect of Carraguard® gel on the vaginal flora in these women; to     evaluate the effect of Carraguard® gel on shedding of HIV-1 in the genital tract of these     women; to evaluate the safety of Carraguard® gel when applied directly to the penis once per     day for 7 days by sexually abstinent, HIV-positive men; to assess whether symptoms reported     by female and male participants during the study may be related to the use of Carraguard®     gel; and to examine dimensions of the acceptability of, and compliance with, the study and     placebo products.   "
180874|NCT00213018|"     The primary aims of the study were to assess the safety and acceptability of Carraguard ™     (PC-515) when applied vaginally at least three times weekly for 6-12 months. Secondary aims     were to gather preliminary data on Carraguard's effectiveness in preventing male-to-female     transmission of HIV.      The hypothesis was that Carraguard would cause little or no significant irritation, including     lesions; that women would find Carraguard acceptable. The study was not powered to determine     effectiveness, but based on safety, acceptability and feasibility parameters, the outcome of     the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3 efficacy     trial.   "
180875|NCT00213031|"     The primary aims of the study were to assess the safety and acceptability of PC-515 when     applied vaginally at least three times weekly for 12 months. Secondary aims were to gather     preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of     HIV, and other STIs.      The hypothesis was that Carraguard would cause little or no significant irritation, including     lesions; and that women would find Carraguard acceptable. The study was not powered to     determine effectiveness, but based on safety, acceptability and feasibility parameters, the     outcome of the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3     trial.   "
180876|NCT00213044|"     Randomized, controlled, double-blinded, cross-over trial of 60 HIV-infected women recruited     from general medical clinics, family planning clinics, groups/organizations working with     persons living with AIDS to assess product safety, effect on genital tract HIV shedding, and     product acceptability with vaginal use of Carraguard gel among HIV-infected women. Women had     to be abstinent or in a seroconcordant relationship with only one partner for the study     period.   "
180877|NCT00213057|"     The primary aims of the study were to assess the safety and acceptability of Carraguard     applied vaginally prior to sexual intercourse for six months in both women and men; and to     examine several dimensions of acceptability. Secondary aims were to gauge reactions to a     non-contraceptive microbicide, to assess use dynamics among Thai couples and to observe     preliminary indications of sexually transmitted infections and reproductive tract infections     averted.      The hypothesis was that Carraguard would cause little or no significant irritation, including     lesions; and that women and men would find Carraguard acceptable.   "
180878|NCT00213070|"     The purpose of this study is evaluate the clinical efficacy and safety of Miglitol in     patients with Type2 Diabetes Mellitus with treated insulin.   "
180879|NCT00213083|"     The purposes of this study are to determine whether Carraguard® Gel can prevent the     transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe     for vaginal use.   "
180880|NCT00213096|"     The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal     contraceptives containing a progestin and an estrogen on liver proteins and coagulation     factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring     containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was     compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and     ethinyl estradiol.   "
180881|NCT00213109|"     The purpose of this study is evaluate the clinical efficacy and safety of Miglitol in     patients with Type1 Diabetes Mellitus treated with insulin.   "
180882|NCT00213122|"     In this study, the effect of miglitol on daily plasma glucose will be evaluated in type 2     diabetic patients treated with insulin.   "
180883|NCT00213135|"     The purpose of the study is to determine if cladribine tablets are a safe and effective     treatment for relapsing-remitting multiple sclerosis (RRMS).   "
180884|NCT00213148|"     The purpose of this study is to investigate and compare the safety and efficacy of various     doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating     follicular growth and ovulation in infertile women with ovulatory dysfunction.   "
180885|NCT00213161|"     The purpose of this study is to determine the smallest dose of Sprinkles, a single-serving     package of iron and other micronutrients, to treat infants with iron deficiency anemia in     India. Results have implications for programs using Sprinkles worldwide because lower doses     of iron may have fewer side effects.   "
180892|NCT00213252|"     The primary objective of this study is to evaluate if children with acute asthma given a     single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast     will achieve a therapeutic failure rate at day 8 not significantly higher than those given     six daily doses of oral prednisolone. Secondary objectives include comparison of the two     groups with respect to the changes in symptoms, beta2 agonists, clinical asthma score and     days without asthma by day 8.   "
180893|NCT00213265|"     We plan to study whether the 7-valent pneumococcal conjugate vaccine (Prevnar™) is safe and     effective in protecting children who have had a solid organ transplantation and healthy     children from pneumococcal infections.      We expect that two or more doses of Prevnar™ will result in similar antibody responses among     transplant recipients compared with healthy control subjects, and that children who have     undergone solid organ transplant will have a similar number of serious vaccine-related     adverse events within 7 days after Prevnar™ as the healthy patients.   "
180894|NCT00213278|"     This study is examining whether Vinblastine is an effective drug to shrink low grade glioma     brain tumors in children, and what the side effects are.   "
180895|NCT00213291|"     This is a study to determine the safety and effectiveness of Darbepoetin (Aranesp) given     every 14 to 28 days to treat low red blood cells in children with chronic kidney failure.   "
180896|NCT00213304|"     We hypothesize that children listed to undergo solid organ transplant will experience (at the     very most) a low rate (< 5%) of serious vaccine-related adverse events within 42 days after     immunization with live attenuated Oka/Merck varicella vaccine (VARIVAX™). We also hypothesize     that the immunogenicity of two doses of VARIVAX™ in the study population will be similar to     historical data in healthy subjects and that the efficacy of two doses of the vaccine in the     study population will be similar to that of healthy subjects.   "
180897|NCT00213317|"     The purpose of this study is to evaluate the effect of sacral nerve magnetic stimulation on     the colonic motility in healthy subjects, in incontinent and constipated patients.   "
180898|NCT00213330|"     Irritable bowel syndrome is responsible for chronic abdominal pain, diarrhea and/or     constipation. It is a very frequent problem. However, the exact cause of irritable bowel     syndrome remains unknown. The purpose of this study is to look for a different cerebral     response by magnetic resonance imaging after rectal stimulation in patients with irritable     bowel syndrome compared to healthy subjects and to patients with digestive organic disease.     Our hypothesis is that irritable bowel syndrome could be a problem of cerebral integration of     visceral stimulation.   "
180899|NCT00213343|"     the purpose of this study is to compare the oesophageal depression induced by bilateral     phrenic nerve stimulation during swallowing in patients with neurological laryngeal     aspiration   "
180900|NCT00213356|"     Anal incontinence and constipation are frequently observed in patients with neurological     disease. The purpose of this study is to evaluate the neurological control of the anal     sphincter in healthy subjects, patients with neurological disease by a new     electrophysiological technique. This technique consists in recordings of anal sphincter     responses after magnetic stimulations of the cortex and the sacral nerves.   "
180901|NCT00213369|"     Aspiration could induce major respiratory affection. They are often present after stroke. The     aim of this study is to facilitate swallowing recuperation in stroke patients using     peripheral laryngeal stimulation and to understand its mechanisms using motor evoked     potential and cortical evoked potential.   "
180902|NCT00213382|"     The aims of this study are in four experimental sessions. The aims are:        -  to characterize the excitability of the cortical pharyngeal area with pharyngeal          pressure and electromyograms (EMGs), at rest, in awake healthy subjects;        -  to study its facilitation by inspiration and deglutition; and        -  to study its plasticity by respiration and swallowing.   "
180903|NCT00213395|"     Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute     hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are     determinant to get an optimal NIV efficacy in parallel with ventilatory comfort.      Facial masks during NIV are associated with deleterious consequences like gas leaks around     the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask     discomfort. In order to limit these side effects, a cephalic interface has been recently     designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit     pressure is therefore spread over a larger surface outside the nose area. However, this mask     has a high volume that may interfere with NIV efficacy and may also induce claustrophobic     sensations.      The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask     versus a conventional oronasal mask during AHRF.   "
188865|NCT00328952|"     The purpose of this study is to evaluate the changes in various aspects of auditory verbal     hallucinations during 24-week antipsychotic treatment in naturalistic condition.   "
180904|NCT00213408|"     Catheter ablation of typical atrial flutter is a well established technique with a high acute     success rate and very low complication and recurrence rates. It has also been shown that     ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in     quality of life. We sought to evaluate the cost/effectiveness of catheter ablation as the     first line therapy in patient suffering from their first symptomatic typical atrial flutter     episode. This study is a multicenter trial in which patients with a first symptomatic episode     of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic     drugs after electrical cardioversion. Clinical examination, quality of life questionnaires,12     leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following     randomization.The primary end-point is the absence of recurrence of typical atrial flutter at     - and 12 months of follow up. The secondary end points are the cost and the     cost/effectiveness ratio of these two approaches.   "
180905|NCT00213421|"     to compare efficacity and tolerance of two stratégies of dermoval application in treatment of     bullous pemphigus.   "
180906|NCT00213434|"     The purpose of this study is to determine if the mandibular advancement by Herbst device is     effective in the treatment of moderate obstructive sleep apnea patients.   "
180907|NCT00213447|"     immunological study of the T cell repertoire phenotype and functionality in hypersensitivity     syndrome.   "
180926|NCT00213694|"     Clinical response to chemotherapy. Biological parameter (PSA) and RECIST evaluation.     Association of Docetaxel (J 15) and Celecoxib.   "
180908|NCT00213460|"     Small bowel involvement is still recognized to be associated with great morbidity and     mortality in SSc patients, leading particularly to malabsorption and intestinal     pseudo-obstruction. Intestinal disorders directly related to SSc have, in fact, been reported     to be one of the most common causes of death.      In a previous prospective study, we have demonstrated the high prevalence of small intestinal     involvement in SSc patients, using upper intestinal manometry; in turn, 88% of our SSc     patients had upper intestinal motor disturbances. However, to date, no authors have yet     analyzed the course of upper intestinal motor dysfunction in SSc.      The aims of this study were therefore to assess the 5-year course of small bowel motor     disorders, using manometry in patients with systemic sclerosis (SSc), and to investigate for     an association between upper intestinal motor dysfunction outcome and other clinical     manifestations of SSc.   "
180909|NCT00213473|"     the aims of SACHA study was to appreciate prevalence, evolution and follow-up, treatment     response of patients with acquired hemophilia with biological and clinical data. Inclusion     criteria were factor VIIIc below 30% associated with presence of Facgteur VIII inhibitor     (titer > 1 u Bethesda. Clinical and biologival data were obtained at Day 0 (as soon as     possible and at 1, 3, 6 and 12 months.Informations were notified to co-investigators with the     help of two french medical society (Internal medicine, french haemostasis and thrombosis     society.   "
180910|NCT00213486|"     The standard non surgical therapy of locally advanced esophageal cancer is based on a     definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. One of the     alternative regimen which is being studied is the combination of a weekly cisplatin and     irinotecan schedule with radiotherapy. This multicentric phase II clinical trial primarily     aimed to evaluate the clinical complete response rate and secondary objectives were toxicity     profile and survival.   "
180911|NCT00213499|"     The clinical efficacy of noninvasive ventilation (NIV) has now been demonstrated in the     management of acute-on-chronic respiratory failure (ACRF) of various etiologies. Endotracheal     mechanical ventilation (ETMV) can lead to numerous complications and weaning difficulties     increasing the risk of prolonged ETMV, morbidity and mortality as well as excess cost of     intensive care. Therefore, it could be interesting to use NIV for delivering effective     ventilatory support and reduce the length of ETMV in ACRF patients still not capable to     maintain spontaneous breathing. From the interesting but discordant results of two recent     randomised controlled trial, a working group from the Société de Réanimation de Langue     Française (SRLF) decided to perform a new prospective randomised controlled and multicenter     trial. The aim of the study is to assess the usefulness of NIV as an extubation and weaning     technique in ventilated ACRF patients. The methodology used compares three weaning strategies     in parallel in ACRF patients considered difficult to wean : invasive conventional weaning     (group A), extubation relayed by nasal oxygentherapy (group B), and extubation relayed by NIV     (group C). Based on the main end-point defined as the weaning success/failure rate, 208     patients from17 investigator centers are planned to be included. Results of the study will     also allow to assess the respective impact of the three weaning strategies on the length of     ETMV and weaning, the mechanical ventilation-related morbidity, the patients lengths of stay     and mortality.      Results of the VENISE trial should permit to improve the management of the difficult to wean     ACRF patients and thus to contribute to more define the place of NIV among the weaning and     prevention of re-intubation strategies in these patients.   "
180912|NCT00213512|"     to treat in an open non comparative clinical study patients presenting pemphigus with     corticodependance, corticoresistance and contre-indication to systemic steroids.   "
180913|NCT00213525|"     Scleroderma is an autoimmune disease of unknown origin. Recently, the role of environmental     factors, and particularly toxic drug exposure, in the genesis of scleroderma has been     suggested.      This prompted us to conduct this prospective, case-control, multicentric study, including 2     groups of subjects:        -  100 patients with scleroderma        -  300 sex- and age-matched healthy controls. The aim of our study is to determine whether          exposure to toxics is higher in patients with scleroderma compared with healthy          controls.   "
180914|NCT00213538|"     The objective of the study is to identify and validate predictive markers of anakinra     responsiveness in RA patients by a transcriptomic approach.      Patients with active RA (ACR criteria) were given subcutaneous anakinra (100mg/d) 3     associated with metotrexate. Anakinra efficacy was evaluated at week 12, using the EULAR     response criteria.      A blood sample was collected just before the onset of anakinra treatment and total RNAs were     extracted from the peripheral blood mononuclear cells. The [33P] radiolabeled mRNAs were     hybridized (duplicate or triplicate) over a set of 10.000 human cDNA probes spotted at a high     density on nylon membranes. Data were normalized and filtered to allow the comparison between     RNA samples. Statistical analyses were performed with the R software and hierarchical     clustering was performed with the Cluster and Tree View softwares.   "
181942|NCT00227123|"     The purpose of this study is to determine whether quetiapine or risperidone are effective in     treating mood symptoms, drug cravings and use in bipolar disorder with concurrent cocaine or     methamphetamine dependence.   "
180915|NCT00213551|"     Gut barrier plays a major role in defence of the organism. During catabolic states, like     major surgery or inflammation, gut barrier could be altered. It has been reported that     preoperative nutritional support may have beneficial effects on clinical outcome in patients     with surgery on gastrointestinal tract. Glutamine, which is a conditionally essential amino,     have been reported to modulate inflammatory, antioxidant responses and protein metabolism in     intestine. In addition, glutamine supply improves clinical outcome in critically ill     patients. Antioxidant micronutrients may also have some beneficial effects in intestine by     improving antioxidant response and might also regulate protein expression. Nevertheless,     effects of glutamine combined to antioxidant micronutrients have not been evaluated.      Thus, the aim of this study will be to assess the influence of glutamine and     glutamine-antioxidant micronutrients-containing solutions on intestinal response in humans.   "
180941|NCT00213889|"     This study uses a sequence analysis for TWIST and other craniofacial development genes, among     patients presenting with facial clefting.   "
181096|NCT00206102|"     This Phase IV, randomized, parallel-group study is designed to evaluate the cataractogenic     potential of quetiapine fumarate (SEROQUEL) compared with that of a putative     non-cataractogenic antipsychotic medication risperidone (RISPERDAL). This study is being     conducted to fulfill the SEROQUEL Phase IV commitment regarding evaluation of cataractogenic     potential.   "
180916|NCT00213564|"     The objective of the study is to identify and validate predictive markers of infliximab     responsiveness in RA patients by 2 approaches: i) measuring biochemical, immunological and     bone markers in sera because of their involvement in pathogenic mechanisms; ii) identifying     gene-expression signatures in PBMCs by the transcriptomic analysis.      Patients with active RA (ACR criteria) were given i.v. 3 mg/kg infliximab associated with     metotrexate at weeks 0, 2, 6, and every 8th week. Infliximab efficacy was evaluated at week     14, using the EULAR response criteria.        1. Just before the starting of infliximab treatment, the following parameters were measured          in the sera: i) immunological tests: rheumatoid factor (IgA, IgG, IgM), anti-CCP, autoAb          recognizing the 27 C-terminal fragment (ACAST-C27) and domain I (ACAST-DI) of          calpastatin, anti-G6PI, anti a-enolase, anti-keratin and anti-perinuclear factor; ii)          biochemical markers: CRP, MMP-1, MMP-3, TIMP-1, TIMP-2; markers of bone resorption:          pyridinolin, deoxypyridinolin, osteoprotegerin, sRANKL, COMP. The predictive value of          each parameter for a response/non-response to infliximab was analysed using Fischer's          exact, Mann-Whitney and Chi2 tests.        2. A blood sample was collected just before the onset of infliximab treatment and total          RNAs were extracted from the peripheral blood mononuclear cells. The [33P] radiolabeled          mRNAs were hybridized (duplicate or triplicate) over a set of 10.000 human cDNA probes          spotted at a high density on nylon membranes. Data were normalized and filtered to allow          the comparison between RNA samples. Statistical analyses were performed with the R          software and hierarchical clustering was performed with the Cluster and Tree View          softwares.   "
180917|NCT00213577|"     The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus     500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic     urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.   "
180918|NCT00213590|"     The purpose of the study is to show the efficacy of reduction of cyclosporine A exposure     measured by the area under the curve by Bayesian estimator on the primary prevention of     degradation of the renal function in renal transplant recipients   "
180919|NCT00213603|"     The goal of this multicentric French randomized trial is to determine the best auto     fluorescence bronchial endoscopic follow-up strategy in high risk patients bearing low grade     bronchial precancerous lesions. Subjects will be randomly assigned to one of the following     arm :      (A) every 6 months clinical and chest Xrays follow-up without intermediate endoscopy, (B)     every 6 months clinical and chest Xrays follow-up including repeated autofluorescence     endoscopy and biopsies on a 6 months basis in case of low grade dysplasia or on a one year     basis in patients without dysplasia.      After 36 months follow-up, each patient from the two groups will be subjected to a final     autofluorescence endoscopy and biopsy and a Spiral Chest Xray.      The final analysis will compare between the two groups :        1. The probability of progression from an initially identified low grade lesion to a high          grade lesion        2. The probability of respiratory epithelial tract progression assessed by the occurrence          of a lung cancer or high grade lesion.        3. The characteristics of lung cancers detected in each arm        4. In both arm, the influence of risk factors and persistent exposure to tobacco on lesion          evolutivity.   "
180920|NCT00213616|"     Bilateral laryngeal reinnervation induces a rise in laryngeal resistance and speech     alteration. The aim of this study is to propose laryngeal reinnervation by a phrenic nerve     root to patients with bilateral laryngeal paralysis.   "
180921|NCT00213629|"     The diagnosis of the different forms of inflammatory myopathies (polymyositis,     dermatomyositis, inclusion-body myositis...) remains difficult which may lead to     unappropriate patient care.      Objective 1 : to develop and evaluate the diagnostic value of a dedicated DNA-array     (myoARRAY) for adult-onset muscular diseases with focus on inflammatory myopathies.      Objective 2 : to evaluate the diagnostic value of T cell repertoire (TcLand) analysis to     distinguish different forms of inflammatory myopathies.   "
180922|NCT00213642|"     Cisplatin is a heavy-metal complex widely used in the treatment of a variety of malignancies,     including small cell and non-small cell lung cancer, ovarian, bladder, head and neck,     esophageal, cervical and germ cell tumors. The administration of cisplatin is commonly     associated with certain drug-induced toxicities that may limit their clinical utility and     adversely affect the quality of life of patients undergoing treatment. Although many advances     have been made in reducing some of the toxicities associated with platinum drug therapy, it     is clear that dose-limiting nephrotoxicity remains a major stumbling block in the use of this     compound. Subtle changes in renal function occur without overt renal insufficiency,     consisting of a decrease in effective renal plasma flow and tubular dysfunction despite     aggressive hydratation. Early tubular damage occurring within 1 to 3 hours after cisplatin     administration has been demonstrated by measurement of urinary beta 2-microglobulin, a     sensitive marker of tubular injury. The chronic lesion has become of greater concern in     recent years as many patients have been cured or placed into long-term remission due to     cisplatin treatment. It consists of a decrease in glomerular filtration rate, which is not     necessary characterized by a remarkable increase in serum creatinine. Cumulative tubular     damage has been demonstrated by increased urinary excretion of tubular enzymes such as     alanine aminopeptidase and beta 2-microglobulin. In this setting, predicting the occurrence     of chronic cisplatin-induced nephrotoxicity remains a clinical challenge.      Tc-99m mercaptoacetyltriglycine (MAG3) is predominantly a proximal tubular secretion renal     agent without cortical fixation indicated for dynamic renal studies to evaluate cortical     tubular function and collecting system drainage. Tc-99m MAG3 and is the agent of choice for     obstructive uropathy and diffuse functional abnormalities of the renal cortex. The aim of     this study was to evaluate by means of Tc-99m MAG3 scintigraphy the acute and subacute     impairment of tubular secretion after cisplatin administration in patients with head and neck     cancer receiving chemotherapy.   "
180923|NCT00213655|"     Evaluation of maintenance BCG immunotherapy (dose 27 mg) in superficial bladder tumors. Two     randomized arms (every 3 or 6 months) will be studied for a population of 300 patients.   "
181996|NCT00227916|"     The purpose of this study is to test the efficacy of an individual motivational interview for     reducing alcohol and marijuana-related harm as well as alcohol and marijuana use in     incarcerated teens.   "
180924|NCT00213668|"     This study investigates the effects of enterally supplied glutamine on gastric emptying,     intestinal transit, age of total enteral nutrition and age at the end of hospitalisation.     Forty neonates, aged at least 2 days and free of acute illness participate in a prospective,     randomised, double-blind study. All are fed with parenteral and enteral nutrition enriched     with glutamine (0.7 g/kg/per day, group 1) or isonitrogenous control (group 2). Gastric     emptying is analysed by sequential measure of intragastric residue by diluted polyethylene     glycol (PEG) 4000. Intestinal transit is analysed by Rouge Carmin test.   "
180925|NCT00213681|"     To evaluate whether bilevel positive airway pressure more rapidly improves ventilation than     continuous positive airway pressure (CPAP) in patients with acute pulmonary edema. CPAP is     delivered via a simple device connected to oxygen.   "
180927|NCT00213707|"     Re-infection of the liver graft occurs universally following liver transplantation for     HCV-induced end stage liver disease. Interestingly, the manifestation of HCV infection     ranging from an asymptomatic carrier state to rapid progression to liver cirrhosis is     extremely variable from one patient to another. The host and viral factors being responsible     for the different course of HCV infection are poorly understood. Our study will focus on     dendritic cells which are known to play a critical role in the control of viral infection.     Viral factors (quasispecies evolution) will also be analysed and Th1 Th2 cytokines produced     in the serum evaluated.Thirty liver transplanted patients will be included : 20 patients     transplanted for HCV-related disease and 10 controls transplanted for non HCV-related     disease. Blood samples will be taken just before transplantation and at different time     -points up to 5 years after transplantation. Function of blood monocyte-derived DC will be     evaluated. Circulating blood plasmacytoid (pDC) and myeloid DC (mDC) sub-populations will be     enumerated. HCV quasispecies evolution will be analysed. This study may help to define     prognostic markers on progression of hepatitis C in liver transplantation and allow the     development of new immunotherapeutic drugs   "
180928|NCT00213720|"     Objective: To determine if the treatment of subclinical hyperthyroidism will reduce the rate     of atrial fibrillation, the main complication of this condition.   "
180929|NCT00213733|"     This is a prospective study of surgically resected samples and lymph nodes of lung cancer     patients. For histopathologically positive lymph nodes from a complete resection, the     investigators would like to analyse tumor tissue by allelotyping and comparing these results     with those observed in the primary lung tumor to establish a cartography of molecular     alteration in resected lung cancer. For non histopathologically positive lymph nodes, the     investigators would like to research the presence (or not) of micrometastasis by     allele-specific PCR (polymerase chain reaction).   "
180930|NCT00213746|"     Viability assessment remains a clinical challenge in patient with coronary artery disease and     left ventricular dysfunction. Several imaging modalities are available for evaluating     myocardial viability, based either on perfusion or on contractile reserve analysis. Briefly,     perfusion analysis is highly sensitive and contractile reserve highly specific. A combined     analysis of both perfusion and contractile reserve has been proposed to improve the     diagnostic accuracy in patient referred for a revascularization procedure. However, the value     of this combined analysis has not been validated in unselected patients referred for     viability assessment.      The patients enrolled in the study will undergo a nitrate enhanced rest gated SPECT using a     Tc-99m labeled tracer (sestamibi or tetrofosmine) followed by a second gated SPECT acquired     during a low-dose dobutamine infusion (10 mcg/kg/mn). All patients will have a 6-month     clinical and imaging follow-up, including physical examination and a nitrate enhanced rest     gated SPECT using the same radiopharmaceutical. All treatments received during this 6-month     period will be recorded, including medical therapy and coronary revascularization     (angioplasty, stenting and CABG).      Finally, the value of baseline perfusion and contractile reserve analysis in predicting left     ventricular ejection fraction changes at 6-month follow-up will be evaluated.   "
180931|NCT00213759|"     Prevention trial of nosocomial infections in neutropenic prematures with G-CSF   "
180932|NCT00213772|"     Comparison of patients with documented PCT and HCV infection, documented PCT without HCV, HCV     infection without PCT and controls without HCV or PCT.      Single blood + urine sample uptake to investigate : mutations in HFE gene, uroporphyrinogen     decarboxylase activity, HCV genotye, history of disease.   "
180933|NCT00213785|"     A study of plasmatic concentrations of endothelin-1 (ET1), atrial natriuretic peptide (ANP)     and brain natriuretic peptide (BNP) in acute ischemic stroke.   "
180934|NCT00213798|"     The majority of lung cancer patients have a tumor-derived genetic alteration in circulating     plasma DNA that could be exploited as a diagnostic tool. The aim of this study is to evaluate     if plasma DNA can be used as a valuable non invasive test to monitor disease progression     without assessing the tumor.   "
180935|NCT00213811|"     This study is based on the study of the natural history of a rare disorder: the Bardet-Biedl     syndrome (BBS) (which is associated with retinitis pigmentosa, polydactyly, cognitive     impairment, obesity, and kidney failure). The clinical, biological, and radiological features     of adult patients are studied. In parallel, a molecular study is performed on the known genes     to date (8 genes from BBS1 to BBS8) and to identify new genes involved. The parts of the     study are combined in a phenotype-genotype correlation study.   "
180936|NCT00213824|"     This is a study of the expression of nogo and reticulon genes in the skeletal muscle of     patients with amyotrophic lateral sclerosis (ALS).   "
180937|NCT00213837|"     This trial will study the reconstruction of the anterior part of the mandible and the     adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or     not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free     microanastomosed bone flaps that are often associated with important morbidity.      The implant is consolidated by two prolonged parallel plates of titanium, allowing their     fixation to the bone, easy to fix in a short time.   "
180938|NCT00213850|"     The purpose is to obtain reference values of respiratory resistance (a technique widely used     in children), in adults. The interest is that this technique needs only little co-operation     and would be particularly adapted in subjects in whom co-operation is insufficient for other     measurements.   "
180940|NCT00213876|"     At present, diagnosis of oligodendroglioma is made on histological and radiographic criteria     in the French Mayo-Ste Anne classification. The less frequent grade A oligodendrogliomas are     characterized by no vascular contrast on RMN evaluation comparatively to grade B forms. This     benign histological subtype relapses in few cases with a more aggressive histology. To     determine these relapsed cases at diagnosis, a collection of tumour begun in February 2004.     Then, our study was designed to identify diagnostic molecular and metabolic markers that     could eventually be used as a signature characterising grade A versus grade B     oligodendrogliomas. The molecular analysis will use genomic techniques like allelotyping     study, quantitative real-time PCR, gene sequencing , serial analysis of genomic expression     and immunohistochemistry, since the metabolic study will be the spectroscopic examination of     in vivo tumour. This study will include paediatric and adult patients followed for     oligodendrogliomas, medulloblastomas and gliomas to compare the different tumour signatures.     All these results will be correlated to survival and clinical features.   "
180942|NCT00213902|"     The objectives of this study are:        1. To evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac          remodeling and to improve hemodynamics in diastolic heart failure (DHF).        2. To evaluate the effect of clonidine on neurohormones and quality of life in patients          with DHF.      The study is a double-blind, placebo-controlled study evaluating the effects of clonidine     compared to placebo in patients with DHF. A total of 70 patients with DHF will be randomized     in a 1:1 ratio to:        1. placebo (n=35) or to        2. clonidine (n=35) in a dose of 0.075 mg twice a day for the first 6 weeks followed by          uptitration to 0.150 mg twice a day for 6 months.      The primary outcome is the reversion of cardiac remodeling and hemodynamic parameters     evaluated by magnetic resonance imaging (MRI) and echocardiography.   "
180943|NCT00213915|"     -  exercise capacities are still altered after heart transplantation partly due to          peripheral endothelial dysfunction        -  cyclosporin-induced renal dysfunction may be due to renal endothelial dysfunction and          can be reversed in an animal model by L-arginine supplementation        -  to determine the potential beneficial effect of L-arginine supplementation on exercise          capacity and renal function of heart transplant recipients   "
180944|NCT00213928|"     To help Treat Lymphedema of the Arm in Breast Cancer Survivors with Horse chestnut Seed     Extract   "
180945|NCT00213941|"     Transient tachypnoea of the newborn (TTN) is a common cause of hospitalisation in the     neonatal period, complicating 1 to 1,5 per cent life birth. Predisposing factors are     prematurity, birth after C section, especially before the onset of labor. The main factor     leading to this condition is a lack of absorption of the fluid contained in the alveolar     space resulting in an early respiratory distress which normally resolves in two to five days     with oxygen supplementation.      Meanwhile, some neonates will experience a complicated evolution requiring ventilatory     support and hospitalisatioon in neonatal intensive care unit. This complication is not     preventable and could result either of a surfactant deficiency (primary or secondary) or a     persistent pulmonary hypertension of the neonate (PPHN).      In this study, a cohort of newborn presenting TTN will be followed, in order to evaluate, at     initial admission, pulmonary maturation (with fetal lung maturity test and the stable     microbubble test) and to seek for PPHN (echochardiography). Therapeutic management will be     done according to standard care and classification of the neonate will be performed according     to their clinical evolution: group 1 (uncomplicated TTN) and group 2 (complicated TTN).      Statistical analysis will compare results of the tests at initial evaluation in the two     groups, and accuracy of the tests to predict a complicated evolution will be established.   "
180946|NCT00213954|"     Nerve block anaesthesia is wildly practised in France, avoiding general anaesthesia in a     number of cases and producing excellent post-operative analgesia in trauma and orthopaedic     surgeries. Even realised by experimented anaesthetists, 5-15% of failures and rare     complications (such as vascular puncture, paresthesia, systemic local anaesthetic toxicity,     epidural and spinal anaesthesia, neuropathy) are noticed. The aim of the study is the     evaluation of an ultrasound-guidance technique in the four predetermined blocks and the     incidence of their complications.   "
180947|NCT00213967|"     This study will determine whether decreasing pain associated with intramuscular injection by     decreasing needle temperature could be an inexpensive, simple way to decrease injection fear     and increase immunization rates.   "
180948|NCT00213980|"     This is a two arm, double-blind randomized study looking at the effect of zoledronate, a     bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.   "
180949|NCT00213993|"     The objectives of this study are to evaluate the effectiveness of an antiperspirant in     preventing or attenuating the severity of palmer-plantar erythrodysesthesia associated with     the Food and Drug Administration (FDA)-approved doses of capecitabine. The hypothesis is that     cytotoxic compounds in sweat will be prevented from being deposited in the skin and causing     chronic toxicity.   "
180950|NCT00214006|"     First, to establish a comparison of the pathophysiology of carotid atherosclerosis and the     genetic and environmental variables that cause those plaques to become symptomatic. Second,     to differentiate between vulnerable plaque and other types of plaque using ultrasound     elastography, MRI data, trans-cranial doppler along with RF (radio frequency) analysis of     back-scattered ultrasonic echoes.   "
180951|NCT00214019|"     This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or     the combination treatment with fluticasone and salmeterol, is associated with a greater     number of sputum eosinophils following antigen challenge and, under these circumstances, the     migrating peripheral blood eosinophils are less adherent.   "
180952|NCT00214032|"     The objectives of this study are to evaluate the effectiveness of Pycnogenol (French maritime     pine bark extract) for arm lymphedema in women following treatment for breast cancer, to     evaluate the accuracy and sensitivity of bioelectric impedence as a measurement of lymphedema     of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.   "
181070|NCT00205764|"     This is an international,multicenter, prospective, open, double randomised and controlled     phase III study to compare the therapeutic efficacy of tandem high dose Melphalan versus     triple intermediate dose Melpahaln in newly-diagnosed myeloma patients   "
180953|NCT00214045|"     The study will help define the best tolerated approach to cystoscopy in women by randomly     comparing flexible to rigid cystoscopy. Previous randomized studies evaluated rigid     cystoscopy under general anesthesia versus flexible cystoscopy under local anesthesia. As a     result of these studies, flexible cystoscopy is performed in the clinic setting generally in     males. However, many women have rigid cystoscopy performed in the clinic while the men have     flexible cystoscopy. No studies to date have evaluated whether flexible cystoscopy is better     tolerated in women compared to rigid cystoscopy in women in the clinic setting.   "
180954|NCT00214058|"     The purpose of this study is to determine the safety and efficacy of this regimen in women     with ovarian or peritoneal cancer   "
181075|NCT00205829|"     This is a prospective, single-centre, cross-over study designed to evaluate the safety and     efficacy of using the bion, an implantable medical device, for the treatment of chronic     headaches. The clinical study is proposed to determine the anticipated adverse event rate and     treatment outcomes at the conclusion of the study. Each trial subject will serve as his/her     own control.   "
181798|NCT00215436|"     The purpose of this study is to determine the safety and efficacy of the investigational drug     in comparison with a placebo.   "
180955|NCT00214071|"     Obstructive sleep apnea (OSA) is a medical problem whose importance is increasing in     recognition and awareness. OSA is associated with the development of hypertension and other     cardiovascular diseases (1,2). OSA has pathophysiologic characteristics that are known to     negatively impact immune function. Both sleep deprivation and hypoxia, hallmarks of OSA,     impair immune responses (6,8,11). In addition, patients with OSA are frequently obese and     obesity may be associated with increased chance of infections and immune impairment (14,15).     Adipose cells are known to secrete cytokines and hormones that are involved in the immune     response such as leptin, tumor necrosis factor alpha and interleukin-6 (16-19). Thus, it     seems very likely that OSA may impact antigen-specific immune responses. Although it is known     that characteristics of OSA impact immune function, it is not known what effects clinical OSA     has on immunity.      The central hypothesis of this application is that that patients with obstructive sleep apnea     will have attenuated cell-mediated and humoral immune responses to influenza vaccine compared     to matched control subjects. Our hypothesis has been formulated on the basis that patients     with OSA are sleep deprived and experience repeated hypoxemia that negatively impact both     humoral and cell-mediated immune responses.   "
180956|NCT00214084|"     Obstructive sleep apnea (OSA) is a medical problem whose importance is increasing in     recognition and awareness. The National Commission on Sleep Disorders estimates that 15     million Americans have OSA, many of whom remain undiagnosed (24). OSA is associated with the     development of hypertension and other cardiovascular diseases (1,2). Patients with OSA, like     those with congestive heart failure, hypertension, hypercholesterolemia and diabetes, exhibit     impaired EDV (25-32). OSA is also associated with impairments in endothelium-dependent     cerebral blood flow responses, which may be a risk factor for stroke (33). Impaired EDV is a     result of reduced production or inadequate action of nitric oxide. Since EDV worsens with     disease progression and improves with disease treatment, it serves as a prognostic marker of     vascular function (34-37). In OSA, hypoxia and neurohumoral disturbances increase generation     of reactive oxygen species (ROS) that neutralize nitric oxide and impair     endothelium-dependent responses (9,10,38). One source of ROS in endothelial cells is the     enzyme xanthine oxidase (38). XO is an enzyme present in the vascular endothelium that     significantly contributes to generation of ROS in congestive heart failure,     hypercholesterolemia and diabetes (13-17). Inhibition of XO improves endothelium-dependent     resistance vessel responses in these populations (13-17), but it is unknown if XO     significantly contributes to oxidative stress and endothelial dysfunction in OSA. The central     hypothesis of this application is that inhibition of XO with allopurinol will reduce     oxidative stress and generation of ROS, thereby improving nitric oxide bioavailability and     EDV in OSA. Our hypothesis has been formulated on the basis that patients with OSA experience     repeated hypoxemia that increases activity of XO and other enzymes, thus increasing the     generation of ROS that negatively impact EDV. Hypoxia is detrimental to vascular homeostasis     since it increases generation of ROS through direct mechanisms and via activation of XO.   "
180957|NCT00214097|"     The purpose of this study is to examine the clinical feasibility of using IMRT combined with     daily pretreatment prostate localization to deliver increasingly hypofractionated treatment     courses. Progressively larger fraction sizes will be delivered in a phase I design based on     both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design     utilizes schemas that maintain an isoeffective dose for late effects, while predicting that     tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if     proven effective and safe, would result in significant cost saving and more efficient use of     resources.   "
180958|NCT00214110|"     This is a single-center, phase 2 randomized clinical trial of tamoxifen on mean percent     predicted isometric muscle strength in patients with amyotrophic lateral sclerosis (ALS). The     purpose is to determine whether the triphenylethylenetamoxifen, used as adjuvant therapy in     the treatment of breast cancer, can delay the loss of isometric muscle strength in ALS     patients.   "
180959|NCT00214123|"     The purpose of this trial is to pilot reducing the duration of radiation treatment for lung     cancer patients from 6 to 5 weeks using tomotherapy. Specific patient doses will be based on     tumor volume being treated. Modeling has shown that increased biologically effective dose     (BED) to tumors can be achieved by shortening the radiation delivery schedule and increasing     the dose per fraction. This requires decreasing the total dose to hold lung toxicity constant     at each dose per fraction level. This is a major paradigm shift in the treatment in this     disease and is projected to result in significant improvements in patient outcome as well as     a substantial cost savings.   "
180960|NCT00214136|"     The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to     escalate the biologically effective dose to the pelvic lymph nodes in a short course of     radiation therapy. An increased total and biologically effective dose will be delivered to     the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard short     course IMRT of radiation (70 Gy at 2.5 Gy/fraction).   "
180961|NCT00214149|"     Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women     with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ     (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted     treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole     breast. The purpose of this study is to determine if an acceptable outcome can be achieved     with radiation delivered only to the region of the tumor bed. If this is true, partial breast     irradiation may lend itself to much shorter treatment times (one week) and the toxicities to     adjacent normal structures (heart, lung, chest wall) will be greatly reduced.   "
180982|NCT00214461|"     The purpose of this study is to determine the safety and tolerability of a modified C.     difficile vaccine at 3 dose levels compared with a placebo control administered via     intramuscular injection in healthy elderly subjects aged > or = 65 years. This is the     companion study to H-030-008, in which healthy younger adults have already been dosed.   "
181071|NCT00205777|"     The purpose of this study is to determine whether bazedoxifene acetate is safe and effective     in the treatment of osteoporosis in postmenopausal women.   "
181072|NCT00205790|"     To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and     Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a     claim of substantial equivalence.   "
180983|NCT00214474|"     The IDEALL Project (Improving Diabetes Efforts Across Language and Literacy) is a 3-arm     randomized controlled trial to explore contextual factors at the patient, clinician, and     organizational level of two patient self-management support strategies. A communication     technology-based intervention (automated telephone diabetes management) and an     interpersonally-oriented intervention (group medical visits)will be compared to usual care     for their ability to improve diabetes outcomes among vulnerable populations in 4 safety-net     health centers in the University of California, San Francisco (UCSF) Collaborative Research     Network.   "
181799|NCT00215449|"     The purpose of this study is to determine the efficacy and safety of the investigational drug     in the treatment of COPD in comparison with a placebo.   "
180962|NCT00214162|"     Web-Based Support for Informal Caregivers in Cancer Brief Summary (including hypothesis):      Informal caregivers need information, skills and emotional support to address physical,     spiritual, and emotional needs associated with chronic illnesses including late stage cancer.     Unfortunately, current conditions force clinicians to reduce their interaction time with     patients and informal caregivers. Complimentary methods must be developed to provide needed     information and support to caregivers. The proposed research will measure and explain the     impact of two computer-based support systems that meet caregiver needs and facilitate     information exchange with clinicians. The system, CHESS (Comprehensive Health Enhancement     Support System) is a non-commercial computer system that provides patients with disease     specific information, emotional support and skill building tools. In the expanded form to be     tested in this study, CHESS with Caregiver Support (CGCHESS) will also provide the caregiver     with more information, support and skills training related to palliative care. CGCHESS will     be further enhanced to communicate essential patient and caregiver information to clinicians     prior to a scheduled clinic visit and when patient symptoms exceed a threshold.      The investigators' primary hypothesis is that CGCHESS + Clinician Report (CR) will reduce     caregiver burden more than CGCHESS because of the additional support caregivers and patients     receive from clinicians who have access to the CHESS clinician report. Secondary analyses     will study the mechanisms of the CHESS effect. Specifically the investigators anticipate that     the CHESS effect on caregivers will be mediated by the CHESS effect on interaction patterns     with clinicians, satisfaction with clinical visits and by the CHESS effect on four patient     outcomes (quality of life, negative affect, average severity of nine common late-stage     cancers).   "
180963|NCT00214175|"     The primary objective is to evaluate and quantify the reproducibility of functional magnetic     resonance imaging (fMRI) maps of the eloquent brain areas corresponding to specific     neurological functions based on activation maps obtained with different thresholds in     patients with benign and biopsy proven low-grade brain neoplasms. Another objective is to     access the impairment in neurological function in image guided intracranial radiotherapy     using neurocognitive assessment tools and to derive dose response curves relating the     impairment in a particular neurological function to the FED received by the area of eloquent     brain corresponding to it.   "
180964|NCT00214201|"     The purpose of this study is to determine whether Campath-1H induction therapy and the     associated lymphocyte depletion will permit long-term, rejection free renal allograft     function in the absence of maintenance calcineurin inhibitor (CI) therapy.   "
180965|NCT00214214|"     The rationale for the study is to determine if Campath-1H can be used in patients recently     diagnosed with type I DM, to induce a state of immunological unresponsiveness such that     subjects can safely preserve beta cell mass and eliminate or lower insulin requirements,     preserving excellent metabolic control.   "
180966|NCT00214227|"     The purpose of this study is to compare the baseline incidence of variant alleles in the ATM     and/or other DNA repair genes present in the Native American population versus the non-Native     American population. It is thought that a higher baseline incidence of the variant alleles in     the ATM gene may correlate to higher rates and higher grades of radiation toxicities noted in     the Native American population.   "
180967|NCT00214240|"     This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more     effective in reducing the CMV viral load over time, as compared to standard treatment with IV     ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load     weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®.     Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will     occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until     the CMV infection is no longer detectable, whichever is longer duration.   "
180968|NCT00214253|"     Our hypothesis is that a successful clinical islet transplant program can be established at     the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus - based     immunosuppressive drug regimen (Edmonton protocol). We intend to answer the following     research questions: 1) will treatment of islet transplant recipients with thiazolidinediones     (i.e. pioglitazone) enhance post-transplant islet function and reduce the number of islets     necessary to achieve adequate metabolic control? 2) which type 1 diabetic patients are     optimal candidates for islet transplantation (i.e. islet transplant alone or islet after     kidney transplantation)? 3) Can cadaver donor pancreases, which are ordinarily discarded and     not used for pancreas transplantation be used for islet transplantation?   "
180969|NCT00214266|"     The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will     obviate the need for long-term calcineurin inhibitors in renal transplantation. Most     successful strategies to date have relied on the use of either tacrolimus or cyclosporine.     However, the advantage of a calcineurin inhibitor free regimen may include improved renal     allograft function, a lower incidence of hypertension, diabetes, and less drug related side     effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant     patients.   "
180970|NCT00214279|"     Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant     recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and     MMF), while carefully monitoring their graft function. 25 subjects would serve as control     patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and     MMF). Immunologic status will be determined before and after IS withdrawal using a     delayed-type hypersensitivity (DTH) transfer test previously described in the original     submission. Both the steroid withdrawal subjects and the control subjects will undergo the     DTH testing throughout the 3 years of study participation.   "
180971|NCT00214292|"     This study will apply optical spectroscopy to intraoperative margin assessment during surgery     for breast cancer. We hypothesize that a combination of fluorescence spectroscopy and diffuse     reflectance spectroscopy will reliably detect involved surgical margins. Twenty patients with     ductal carcinoma in-situ will undergo a standard lumpectomy followed by scanning with a     sterile optical spectroscopy probe. Frozen sections from the surgical cavity will be used to     evaluate the margins. Optical spectroscopy data will be categorized as benign or malignant     using a statistical algorithm and the results will be compared with the frozen and permanent     section results.   "
180972|NCT00214305|"     Treatment for head and neck cancer often results in significant swallowing problems because     of reduced range of motion (ROM) of the larynx, tongue base, and pharyngeal walls. Our     question is: Is swallowing therapy to improve ROM during swallowing maneuvers efficacious in     patients with reduced ROM?   "
181012|NCT00214864|"     The purpose of this study is to attempt to find better tolerated doses and schedules of this     highly effective combination chemotherapy regimen.   "
181073|NCT00205803|"     The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent     pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this     vaccine in infants.   "
180973|NCT00214318|"     We hypothesize that b2 adrenergic polymorphisms affect b-receptor selectivity in patients     with heart failure treated with either a b1-selective or a b-nonselective agent. b-2     polymorphisms may contribute to differing responses to drug treatment with beta-blockers in     heart failure. Characterizing these polymorphisms may help explain the variability in the     degree of selectivity of action of b-blockers at the b receptor, namely if their action is     specific for the b-1 or b-2 receptor. Part A was conducted at the University of Utah, and all     subjects completed study related activities. Part B (sub-study) consists of genotyping of     blood samples collected in part A, which will be completed at the University of Wisconsin.     Sub-study (samples and DNA isolation) or Part B entailed analyzing an extra 10 mL of blood     that was taken for DNA isolation. Genotyping (i.e. determination of genetic makeup) of beta     adrenergic polymorphisms utilized polymerase chain reaction followed by pyrosequencing.   "
180974|NCT00214331|"     This protocol is a prospective, open-label, multicenter, population pharmacokinetic and     pharmacodynamic study of selected anti-infective agents in pregnant women being treated for     suspected or documented infections.   "
180975|NCT00214344|"     Using the self-regulation theory, an intervention to prepare families for that experience was     developed. This study will assess the impact of the intervention on a family's evaluation of     their preparation and their short-term coping. The site used for this study will be the     Trauma and Life Support Center (TLC), University of Wisconsin (UW) Hospital. After a decision     has been made to withdraw life support, a member of the TLC staff will approach the next of     kin of the patient to inform him/her about the study and inquire about his/her interest to     participate. Using an experimental design, 10 family members will be assigned to the control     group and 10 to the intervention group. Upon agreement, a research nurse will use a coin     toss method for group assignment of the subjects until there are ten in each group.     Experimental group subjects will receive the intervention after the family meeting.     Demographics of the next of kin will be collected at this time. Patient information such as     demographics, diagnosis, and time of withdrawal and death will be collected too. Two to four     weeks after death, a telephone interview will be conducted with the next of kin using the     Evaluation of the Experience of Withdrawal questionnaire and the Profile of Mood State -     shortened version.      Potential benefits are that the families will be prepared for the experience of the dying     patient, which will help them cope better during withdrawal and after their loss. There are     no major risks to the subjects but there might be an increase in psychological distress.   "
180976|NCT00214357|"     The primary research objective is to investigate psychological, behavioral, and physiological     changes in school staff as a result of undergoing meditation and stress reduction training.     Specifically, we hypothesize that school staff undergoing meditation and stress reduction     training will show decreased emotional distress on self-report measures, increased sustained     attention on a behavioral task, and decreased stress levels as indexed by salivary cortisol.   "
180977|NCT00214370|"     The hypothesis of the study is that propofol-fentanyl sedation for lumbar punctures in     children with acute leukemia/lymphoma results in fewer adverse events than propofol sedation     alone. Secondary hypotheses state that propofol-fentanyl sedation results in a better     sedation induction, recovery profile and is preferred by patients/families. The study is a     double blind, randomized, placebo controlled crossover study. Following the induction phase     of chemotherapy, children will be randomized in a crossover manner to receive either     fentanyl-propofol or propofol-placebo for future lumbar punctures. Patients will be studied     on two separate occasions, once with propofol-placebo (normal saline) and once with     propofol-fentanyl. Children will be monitored continuously by pulse oximetry,     electrocardiogram (ECG) and direct nursing and physician observation during the sedation in     accordance with the University of Wisconsin (UW) Pediatric Policy and Procedure. Propofol     will be titrated to a Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score of ≤ 7     for all children. Oxygen saturation, respiratory rate, heart rate and blood pressure will be     recorded every 3 minutes by a study investigator during sedation.   "
180978|NCT00214383|"     The original and primary aim of this study is to evaluate the effects of CHESS with Nurse     Case Management on asthma control (symptom-free days), and adherence factors of children aged     4-12. The investigators have expanded the scope of the specific aims. The criteria for their     expanded aim is to also interview low-income African-American caregivers to gain an     understanding of how they conceptualize their child's asthma, and what they consider to be     barriers or facilitators to managing their child's asthma. There is no change in the     investigators' original aim.   "
180979|NCT00214422|"     BACKGROUND:      -This study represents a progression from findings in four previous NCI ROB protocols     (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to     develop techniques to obtain Magnetic Resonance (MR) biological images and co-register tissue     in prostate cancer patients.      OBJECTIVES:      -The primary objective of the first portion of this study is to assess the feasibility of     using IMRT to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope     optimize this technique with experience.      ELIGIBILITY:      -This is a study of image guided, targeted radiation therapy in patients with high risk of     nodal metastases from prostate cancer. Patients with prostate cancer who have more than 15%     risk of lymph node (as defined by the Partin tables) metastasis will be eligible for this     study.      DESIGN:        -  On the first 10 patients, we will perform approximately 5CT simulations throughout the          course of their therapy. On each simulation, the initial treatment plan will be re-run.          The dose-volume data from target and normal tissues will then be re-analyzed. From this          analysis we will be better able to determine the size of margins needed to account for          organ motion and changes such as varying amounts of gas in the bowel and fluid in the          bladder. To the best of our knowledge, no such analyses have been published.        -  If the initial part of this trial is feasible, we will proceed to a phase I dose          escalation trial of radiation to the at-risk lymph nodes. The primary statistical          objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose          (MTD) of external beam radiation based on evaluating acute toxicity. The study will be          conducted with a dose-escalation design with 3 patients in each dose cohort. If fewer          than 2 of 3 patients experience an acute DLT than patients will be accrued to the next          dose cohort. If 2 or more of 3 patients experience a DLT then the MTD will be exceeded          and the prior, lower dose cohort will be considered the MTD. Secondary objectives of          this study are to relate patterns in gene and protein expression to response and          toxicity and to evaluate the frequency of late term toxicity.        -  Specific procedures and risks will be described in a separate consent to be obtained at          the time of biopsy. Tissue samples will be processed for cDNA microarray testing and          stored for future analysis in the Radiation Oncology Branch, NCI.        -  Anatomic Magnetic Resonance Imaging (MRI) and MR biological images of the prostate and          pelvis will be obtained and tissue will be acquired with biopsy locations precisely          translated (co-registered) to an MR image of reference. A fiducial marker (gold seed)          will be left at the biopsy site as a fiducial marker to direct future radiation therapy          to the prostate. If necessary, additional fiducial markers will be placed for prostate          localization during treatment.   "
180980|NCT00214435|"     Poor compliance is thought to be a major cause of treatment failure. The TEddI study is a     randomised, multi-centre, open-label study in well-controlled treatment-experienced     HIV-infected patients to assess compliance with a once-daily regimen of antiretroviral     therapy versus continuation of current anti-retroviral regimen delivered at least twice     daily.   "
180984|NCT00214487|"     The purpose of this study is to determine whether bifocal soft contact lenses are effective     in controlling the progression of myopia in children and adolescents that exhibit a tendency     to excessively cross their eyes while reading (esophoria or eso fixation disparity). Several     studies have demonstrated that bifocal or progressive multifocal spectacles are effective in     slowing the progression of myopia in children either with near point esophoria and/or with     inadequate focusing at near. A prominent theory for one cause of myopia progression is that     poorly focused images on the back of the eye (retina) cause the eye to lengthen, causing an     increase in myopia. Bifocal contact lenses may reduce this retinal defocus, reducing the     stimulus to eye elongation, and thus may reduce myopia progression.   "
180985|NCT00214500|"     The purpose of this study is to determine whether AT1001 (migalastat hydrochloride) is safe     and effective in patients with Fabry disease.   "
180986|NCT00214513|"     The aim of the study is to determine whether a low-cost home-based training programme can     maintain the achieved effect of physical training on exercise capacity and QOL in patients     with Chronic Heart Failure.   "
180987|NCT00214526|"     The purpose of this study is to demonstrate the effectiveness and safety of the Alair System     for the treatment of asthma.      This will be a multicenter, randomized controlled study comparing the effects of treatment     with the Alair System to standard drug therapy. One-hundred and ten subjects will be     randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control     Group (Medical management only).   "
180988|NCT00214539|"     The purpose of this study is to evaluate the safety and efficacy of the Alair System for the     treatment of severe refractory asthma.      This will be a multicenter, randomized controlled study comparing the effects of treatment     with the Alair System to standard drug therapy in patients with severe asthma refractory to     standard medication therapy. A total of 30 subjects will be randomized 1:1 to the Alair Group     (Medical management + Alair Treatment) OR the Control Group (Medical management only).   "
180989|NCT00214552|"     The hypothesis for this study is that potent anti-secretory therapy with high dose PPI     improves asthma control regardless of either asthma severity or the presence of GERD     symptoms.   "
180990|NCT00214565|"     This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone)     study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately     controlled on diet and lifestyle advice alone during the run-in period. The study comprises a     3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week     double blind treatment period and a 3-week follow-up period.   "
180991|NCT00214578|"     The purpose of this study is to determine whether six months treatment with the antipsychotic     medicine Seroquel (quetiapine) may affect the schizophrenic patient's glucose metabolism   "
180992|NCT00214591|"     This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled     (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled     on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week     placebo single blind run in period followed by a 52-week a double blind treatment period and     a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or     highest tolerable dose during the first 12 weeks.   "
180993|NCT00214604|"     Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in     subjects with dysbetalipoproteinemia.   "
180994|NCT00214617|"     The objective of this research is to understand how Crestor can effectively reduce the levels     of the bad cholesterol, LDL, in blood. It is hypothesized that with a low dose, Crestor will     facilitate the rate of removal of LDL from the blood. At the higher dose, the increased     potency of Crestor is explained by a reduction in the production of LDL by the liver.   "
180995|NCT00214630|"     Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes   "
180996|NCT00214643|"     There is a necessity for the development of new malaria drugs. Some antibiotics are also     effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be     effective against malaria, although it cannot achieve a total cure in all patients. Previous     small studies have shown that in combination with clindamycin, an commonly used antibiotic,     it is highly effective and safe when given for three days, leading to a total cure in most     patients. The current study will evaluate its efficacy in a larger population in Gabon, and     compare its effect with the generally used drug, sulfadoxine-pyrimethamine.   "
180997|NCT00214656|"     Aims and Hypotheses:      This randomised placebo controlled study will test the hypothesis that Recombinant Activated     Factor VII (rVIIa) will improve haemostasis after an inadequate response to conventional     therapy in complex cardiac surgery.      Major bleeding is still of concern in complex cardiac surgery. It has been shown to be     associated with poorer patient outcome and results in the consumption of resources (hospital     costs, manpower and blood bank reserves). This study has the potential to provide evidence     that rVIIa can reduce transfusion requirements and improve patient outcome in a problematic     aspect of complicated cardiac surgery.      The objective is to conduct a multi-centre randomised placebo controlled study that has been     designed to scientifically evaluate the treatment of post bypass coagulopathy in the     association with complex cardiac surgery. The trial design is based on clinical practice that     has evolved over 2 years at the Austin Hospital during which 38 patients have received open     label administration of rVIIa. There is currently no published RCT in this area and there is     no TGA approval for the use of rVIIa for this indication.   "
181044|NCT00205413|"     This clinical research protocol proposes to perform low dose helical computed tomographic     (CT) scanning in 250 high-risk patients (125/year for two years) in order to detect lung     carcinomas when they are small and subject to effective curative therapies.   "
181024|NCT00205153|"     This Team Education and Adherence Monitoring (TEAM) trial will evaluate the     cost-effectiveness of a pharmacy-based intervention in a randomized controlled trial     involving 597 treated hypertensive African American patients in five Wisconsin cities. The     study involves 28 community pharmacies (14 intervention, 14 control) owned by two pharmacy     corporations. Intervention pharmacists and pharmacy technicians implemented a 6-month blood     pressure (BP) monitoring program that involved working together as a team with patients and     their physicians to achieve improved medication adherence, healthy lifestyles, drug therapy,     and hypertension control.   "
180998|NCT00214669|"     People from ethnic minority groups suffer worse ill-health from asthma than those from     majority groups. No studies have reduced emergency care for people from minority groups. We     have developed an education programme to address barriers to improved care for south Asian     people with asthma. The study is set in Tower Hamlets and Newham - the UK's most deprived and     ethnically diverse boroughs. We will invite all the local GP practices to take part, and     using a computer programme, randomised them (like tossing a coin) into two groups - a group     receiving usual care and a group receiving our educational programme. This comprises:        -  Education for specialist nurse and GPs and practice nurses, using our adaptation of an          American education course, designed to improve shared-decision making, goal-setting and          patient-clinician partnership.        -  Lay-led 'expert-patient' education in small groups for patients, using an adaptation of          another American course.        -  Improved follow-up in primary care through appointment-booking by the specialist          nurse.We will invite south Asians aged 3-65 years with asthma after A&E attendance or          hospital admission to take part. Those registered with practices receiving the          educational programme will see the trial specialist nurse in a nurse-run clinic, where          the nurse:             1. provides self-management advice and a treatment plan,             2. makes a follow-up appointment in primary care             3. makes an appointment for lay-led 'expert-patient' sessions.Patients registered with               'usual care' practices receive usual care.      We will decide if our education programme works by comparing the number of emergency visits     to GPs and hospital between the two groups.   "
180999|NCT00214682|"     The purpose of this study is to determine whether folate and vitamin B12, physical activity     and mental health literacy can prevent depression, and folate and vitamin B12 and physical     activity can prevent cognitive impairment in older people. Also the study aims to assess the     benefits for older people in improving their knowledge about mental health in relation to     depression.   "
181000|NCT00214695|"     The purpose of this study is to evaluate the inflow pain using an experimental peritoneal     dialysis solution compared to a current solution for the management of end stage renal     disease (ESRD) in peritoneal dialysis (PD) patients.   "
181001|NCT00214708|"     This randomised controlled trial tests whether screening people registering with general     practices cost-effectively increases the detection of tuberculosis. The study objectives are     to:        1. recruit, and randomise with stratification, forty Hackney general practices to usual          activity or screening for TB primarily during registration health checks (by practice          nurses and GPs) and transfer-in visits for children (by health visitors)        2. implement a screening programme comprising education, resources and clinical support for          intervention practices using proven behaviour change strategies        3. gather outcomes and costs        4. build research capacity within an ELENoR Primary Care Research Team and across a Primary          Care Trust.      The primary outcome is the proportion of TB cases identified in primary care. The study is     powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in     primary care with 80% power at the 5% significance level. Secondary outcomes are rates of     prophylaxis for latent TB infection (LTBI), BCG immunisation, smear negative (early) TB and     costs. Analyses will be by intention to treat.   "
181002|NCT00214721|"     Objective: The purpose of this study is to demonstrate:      -the non-inferiority of an experimental peritoneal dialysis solution compared to a current     solution for the management of end stage renal disease (ESRD) in peritoneal dialysis     patients.   "
181003|NCT00214734|"     The primary objective of this post-authorization safety surveillance is to measure the     incidence of adverse events that are at least possibly related to ADVATE use, in subjects     receiving ADVATE in routine clinical practice.   "
181004|NCT00214747|"     This study is designed to assess the distribution and spread of four different vehicle     formulations in the vagina. In-vivo data will be obtained regarding each vehicle formulation     at various time points after insertion of the gel into the vagina.   "
181005|NCT00214760|"     The purpose of this study is to analyse if the alignment of the stem and the number of     complications of the new resorbable PEGT/PBT centralizer are comparable to the standard PMMA     centralizer during the placement of an uncemented Bihapro hip prosthesis.   "
181006|NCT00214773|"     The objectives of this program are: to further characterize the natural progression of MPS VI     disease; to generate and disseminate information on the care and management of MPS VI     patients to clinical and medical professionals; to provide a resource to physicians and     patients by providing information for optimizing patient care based on aggregate data; to     characterize the clinical response to long-term Naglazyme® (galsulfase) treatment; to further     characterize the long-term safety of Naglazyme® treatment.   "
181007|NCT00214786|"     The purpose of this study is to assess a novel approach to immunosuppression in allogenic     pancreatic islet cell transplant recipients. In addition, the study aims to assess remote     site islet processing with culture for pancreatic islet cell transplantation in human     subjects.   "
181008|NCT00214812|"     This study will assess the distribution of a microbicidal gel in the vagina and confirm the     presence of bare spots. MRIs will be done with and without the addition of the MRI contrast     Gadolinium to the microbicide in order to determine whether the bare spots are an artifact of     the MRI technique.   "
181009|NCT00214825|"     Specific aims for this proposal are to determine in patients with diabetes mellitus the     effects of an aldosterone receptor antagonist on:        1. Coronary microvascular function assessed by MRI perfusion reserve,        2. Endothelial dysfunction assessed by brachial artery reactivity studies, and        3. Inflammation assessed by blood measurements of c-reactive protein (CRP), monocyte          chemoattractant protein-1 (MCP-1), and plasminogen activator inhibitor-1 (PAI-1).   "
181010|NCT00214838|"     The primary objectives of this study are to identify the maximum tolerated dose and to     evaluate safety of atiprimod in patients with advanced cancer.   "
181011|NCT00214851|"     An open labelled trial of Kineret (anakinra) induction therapy (100mg./day) in over a four     week period in the treatment of Familial Cold Urticaria.      Familial Cold Urticaria (FCU) is a rare autosomal dominant condition manifesting symptoms     triggered by exposure to cold and variable in expression. Currently there is no standard     reliable agent available for the treatment of patients with FCU.This study will evaluate the     efficacy of Kineret (anakinra), an interleukin 1 receptor antagonist in induction and     maintenance therapy in patients with FCU.   "
181013|NCT00214877|"     While many bipolar patients treated with mood stabilizing medications experience improvement     in their symptoms, some continue to have ongoing difficulties with concentration and memory.     The purpose of this study is to look at whether these symptoms can be improved by adding the     compound methylene blue to the treatment plan of patients who are already taking lamotrigine.      Methylene blue is an available 'over the counter medication' in Canada. It has been studied     in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies     done in bipolar disorder report that methylene blue has had positive effects on both     cognition and mood. It is important to do further research in this area as we know that, for     patients who continue to have ongoing cognitive difficulties, there is no recognized standard     of care for bipolar patients who experience these type of deficits.   "
181014|NCT00214890|"     Once-daily nucleotide/nucleoside reverse transcriptase inhibitor (NtRTI/NRTI) combinations     form the backbone of many regimens. Although efficacy data exists between tenofovir and the     pyrimidine analogues (i.e. lamivudine and emtricitabine), recent clinical data suggests a     potential interaction between tenofovir and purine analogs (i.e. abacavir and didanosine).      Specific Aim 1: To evaluate the impact of an acyclic nucleoside phosphonate, tenofovir (TDF),     on the intracellular metabolism of a purine nucleoside analog, abacavir (ABC), as a     determinant of the antiviral potency of this nucleotide/nucleoside reverse transcriptase     inhibitor (NtRTI/NRTI) combination.        -  Hypothesis #1: ABC and TDF dosed together will have reduced antiviral activity, as          measured by early plasma HIV RNA decay kinetics, than the drugs given alone.        -  Hypothesis #2: ABC dosed with TDF will have reduced intracellular concentrations, as          measured by the ratio of carbovir triphosphate (active metabolite of ABC) to          deoxyguanosine triphosphate (endogenous nucleotide), compared to ABC given alone.   "
181015|NCT00214903|"     The objective of the active surveillance study is to compare incidence rates of serious     adverse events in users of all types of newly prescribed oral continuous combined HRT     products. The primary focus is the assessment of pertinent cardiovascular outcomes (such as     venous and arterial thromboembolism) in new HRT users for up to 8.5 years.   "
181016|NCT00214916|"     In a previous study, the investigators showed that tight blood glucose control with insulin     during intensive care reduced morbidity and mortality in adult intensive care patients.     Whether this intervention also improves prognosis of pediatric intensive care patients     remains unknown. The current prospective, randomized, controlled study will asses the impact     of intensive insulin therapy on outcome of patients in a pediatric intensive care unit. On     admission patients will be randomly assigned to either strict normalization of blood glucose     according age adjusted values or the conventional approach, in which insulin infusion is     initiated only when blood glucose exceeds 215 mg/dl to maintain blood glucose levels between     180-200 mg/dl.   "
181017|NCT00205062|"     The main hypothesis is that PET-CT will be a valuable diagnostic tool in diagnosing and     evaluating treatment for IBD.   "
181018|NCT00205075|"     The purpose of this study is to determine the effect of moderate alcohol intake on liver     disease caused by HCV in terms of speed of progression as compared to those not drinking     alcohol.   "
181019|NCT00205088|"     The objective of the study is to test the sensitivity and specificity of a shunt tap to     predict shunt failure.   "
181020|NCT00205101|"     The purpose of the study is to prospectively measure pain, function, and patient satisfaction     in 70 consecutive patients treated by lumbar fusion using the Triad allograft. Results of the     Triad allograft will be compared to those of other anterior lumbar interbody fusion (ALIF),     transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF)     surgeries. Patient participation is based on the physician determination that the patient     requires one of these surgeries. Participants will be evaluated pre-operatively and     post-operatively at 3, 6, 12,and 24 month intervals. Clinic procedures will be related to     standard of care except for the completion of several study questionnaires:        1. Back Pain Questionnaire;        2. Oswestry Disability Index Questionnaire;        3. Short Form-36 (SF-36) Survey;        4. Visual Analog Pain Scale (VAS); and        5. The Modems Patient Satisfaction Survey.      Outcome Measurements:        1. The patient's pain is scored by a VAS normalized to 100;        2. Patient function is based on Oswestry scores;        3. General health is assessed by SF-36 completion; and        4. Overall patient satisfaction will be determined by the completion of the Modems.   "
181021|NCT00205114|"     This 3-year collaborative project will develop, implement, and test a comprehensive approach     to the prevention of falls among high-risk older adults in Dane County, Wisconsin through two     complementary strategies:        1. a targeted strategy of an individualized multifactorial intervention for          community-living high-risk older adults. Older adults are defined as aged 65 and older.          High risk is defined as two or more falls in the year prior, one fall with injury, or          one fall with gait and balance problems, as per recent guidelines from the American          Geriatric Society (AGS). The multifactorial intervention consists of an in-home          assessment followed by recommendations to the participant and his/her physician, a          prescription for physical therapy, other referrals (optometry, podiatry, occupational          therapy, etc.) based on the assessment, monthly phone follow-up for 11 months, and a          prescription for long-term exercise after physical therapy.        2. a program to educate primary care physicians, physician assistants, nurse practitioners,          and physical therapists in Dane County in the current diagnosis and treatment          recommendations for fall prevention.   "
181022|NCT00205127|"     In this study we are looking at the blood flow to the heart using two different chemical tags     or tracers that give off a low level of radiation. The tracers used in this study are called     O15-water and F17-fluoromethane. These tracers mix with the blood and will move through the     body. The researchers will use positron emission tomography (PET scans)to track the tracers     as they moe through the heart and chest.   "
181023|NCT00205140|"     What are the demographic and medication utilization characteristics of participants in the     Senior MEDS personalized medication review compared to other community-dwelling elderly, what     is the level of satisfaction with Senior Meds, and does the Senior Meds program lead to     changes in the participants' drug regimen?   "
181093|NCT00206063|"     The purpose of this study is to evaluate tolerability of long-term treatment with     ximelagatran compared to standard treatment with warfarin.   "
181025|NCT00205166|"     We are studying the affect of caffeine on the sensitivity of detecting coronary artery     disease (blockages in the blood flow to the heart) with adenosine tracer scans. Adenosine is     a drug used routinely in patients to relax heart blood vessels in order to assess for the     presence of coronary artery disease. Often, if patients have had caffeine, the adenosine scan     is not used because of the belief that caffeine may reduce the ability to detect coronary     artery disease. We would like to test whether caffeine affects our ability to detect coronary     artery disease with adenosine tracer scanning. We will perform an imaging study of the heart     with adenosine after you have received caffeine.   "
181026|NCT00205179|"     The purpose of this pilot study is to evaluate the potential effects of soy isoflavone     supplements on cognitive function for men and women with Alzheimer's Disease (AD).     Preliminary studies evaluating the effects of soy supplements on memory in cognitively     healthy older adults have yielded promising results that are now being evaluated in patients     with AD. It is hypothesized that isoflavone supplements will ameliorate cognitive declines     for older adults diagnosed with Alzheimer's disease, when compared to subjects on placebo.   "
181027|NCT00205192|"     Cardiac resynchronization therapy shows great promise as a method to improve ventricular     function in heart failure due to dilated cardiomyopathy. It is applied to patients with class     III and IV symptomatic heart failure on optimal therapy. Typical entry criteria in the trials     testing resynchronization have used the electrocardiogram and a prolonged electrocardiogram     (ECG) QRS interval as criteria for dyssynchrony. This is recognized to be quite limited as a     tool for identifying patients. Several new echocardiographic methods for identifying     dyssynchrony have been proposed. The purpose of this study is to systematically examine these     multiple echocardiographic measurement techniques in three conditions:        1. in the patient's native rhythm simulated by changing the pacing system to atrial pacing          only;        2. in conventional dual chamber pacing (DDD mode); and        3. during biventricular pacing. All patients entered into this study will already have had          a biventricular pacemaker placed.   "
181028|NCT00205205|"     A peer mentoring program for persons with SCI was developed. Individuals who experienced SCI     in the past and have adapted well functionally were asked to serve as mentors for individuals     with newly-acquired SCI. These individuals undergo volunteer and peer mentoring training     prior to mentoring activities. They are a subset of the study participants. We are tracking     their satisfaction with life, positive and negative affect, life adjustment, depression, and     social support over time. We hypothesize that measures of adjustment will become more     positive as involvement as a mentor increases. The second subset of study participants are     the individuals with newly-acquired SCI. They complete a baseline assessment of the measures     listed above and then at 6 months, one year, and two years after match with a mentor. We also     collect information about the quantity and quality of the mentoring sessions from both the     mentor and mentee. We hypothesize that the mentee's adjustment will be positively influenced     by the number and quality of the mentoring sessions. Due to the relatively small number of     SCI per year in our program, we opted to offer the mentoring program to all individuals with     newly acquired SCI, thus there is no control group.   "
181029|NCT00205218|"     The purpose of this study is to evaluate various methods for estimating body composition in     human subjects. Each subject is evaluated by several methods that are then compared to a     criterion value. We hypothesize that the prediction method will yield the same result as the     criterion value. The risks to subjects are minimal and all techniques are routinely     performed.   "
181030|NCT00205231|"     This pilot study will investigate the safety and effect of etanercept in HIV infection by     studying HIV replication and immune function (as measured by CD4 counts) in individuals with     HIV infection.   "
181031|NCT00205244|"     Children scheduled for elective surgery are randomized into a control and intervention group.     Children in the intervention group receive a CD and booklet of relaxation and distraction     stories to listen to/read during the preoperative period. Preoperative anxiety is assessed by     the child life specialist in the preoperative holding area. Ease of induction and emergence     from anesthesia are rated by the anesthesia care provider. Post-hospital behaviors are     reported by the parents one week after discharge. It is hypothesized that children receiving     the intervention will have less anxiety, easier induction and emergence from anesthesia, and     fewer changes in post-hospital behaviors than children in the control group.   "
181032|NCT00205257|"     Acute rejection is still a major risk factor affecting the prognosis of kidney transplant     patients. Alloreactive cells of the recipient infiltrate the kidney graft and cause     inflammatory reaction which damages the graft structure and function. Conventional diagnosis     of acute rejection is based on clinical symptoms and kidney biopsy examination. The clinical     symptoms are a result of the kidney damage, which occurs days after the initiation of the     rejection reaction. Kidney biopsy is an invasive and expensive procedure. It has been wished     to have new parameters that can replace/supplement the conventional procedures. Chemokines     are small molecules that attract inflammatory cells. Changes of chemokine levels in the urine     may correlate with the immune status in the kidney. A systematic study to evaluate the     chemokine levels in urine and correlation with the kidney biopsy pathology will answer the     question whether monitoring of urinary chemokines would be useful in predicting graft     rejection/damage.   "
181045|NCT00205426|"     This study seeks to demonstrate that Natrecor® (nesiritide) is safe and effective and has a     favorable hemodynamic profile in lung transplant recipients that will allow for the avoidance     of inhaled nitric oxide (iNO) use. It is estimated that the use of nesiritide will decrease     the otherwise historically mandated use of iNO by 50%, as compared to the necessity of iNO     use by matched historical controls.   "
181130|NCT00207012|"     This is a continuous dosing Phase I Study of BMS-599626 in patients with HER2-expressing     advanced solid malignancies.   "
181046|NCT00205439|"     The primary goal of this study is to determine the prevalence of tracheobronchial carcinomas     in patients with a history of squamous cell cancer of the aerodigestive tract who have been     treated with a curative intent and remain disease free. Detection of pre-invasive and     invasive lesions (moderate to severe dysplasia, CIS) with fluorescence bronchoscopic     surveillance may help to define the natural history of these lesions and allow earlier     intervention should they progress to invasive lesions.   "
181033|NCT00205270|"     Research Question: How do antibody and T cell responses following influenza vaccine compare     among lung transplant patients, patients waiting for lung transplantation and healthy     individuals?      Experimental Design: This interventional parallel group study will compare influenza vaccine     induced immune responses in three groups: lung transplant patients, individuals waiting for     lung transplantation and healthy individuals.      Current and Future Research Activities: Blood will be drawn for these measures of vaccine     induced antibody response before and 2 to 4 weeks after immunization. Another blood draw will     be obtained from up to 30 individuals from among the three groups for measures of T cell     response to immunization. The third blood draw will be done during months 1 to 5 following     influenza immunization. Genetic material (DNA) will be obtained from cells in the blood to     look for genetic markers that may be associated with influenza vaccine response. Blood draws     and immunization for the healthy participants will be done at the General Clinical Research     Center (GCRC) or in the Clinical Research Facility in Rennebohm Hall. The blood draws for the     pre-transplant and post-transplant patients will be coordinated with clinically indicated     laboratory tests in order to avoid additional venipunctures. Influenza immunization is part     of the routine clinical care of patients with lung disease, and only the immune response data     will be considered part of the research study.   "
181034|NCT00205283|"     The purpose of this study is to assess the impact of prospective drug level monitoring and     dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of     HIV-infected patients who have achieved virologic success while receiving a nelfinavir     containing highly active antiretroviral therapy (HAART) regimen.   "
181035|NCT00205296|"     We hypothesize that improvement in cardiovascular fitness is associated with a greater     improvement in insulin sensitivity than improvement in body composition (loss of body fat) is     associated with insulin sensitivity. Towards that we are randomizing children who are     overweight, or children with low fitness levels to exercise intervention 2 or three times per     week.   "
181036|NCT00205309|"     This study will examine the impact of acute illness on sequential airway IgA levels in     intensive care patients who will require prolonged intubation. Infections are the most common     cause of late deaths in non-head injured trauma patients and a frequent cause of morbidity     and mortality in hospitalized patients, especially intubated Intensive Care Unit (ICU)     patients. Nosocomial pneumonia is the most common of these infections, and its incidence in     defined populations of critically injured patients is responsive to route and type of     nutrition. This study will focus on the mechanisms of specific immune mucosal defenses in     intestinal and extraintestinal sites and link enteral feeding (or lack of it) with     maintenance (or deterioration) of respiratory mucosal defenses.   "
181037|NCT00205322|"     The combination of oxaliplatin, 5-FU, leucovorin, and capecitabine is hypothesized to retain     and potentially improve upon the activity of the FOLFOX regimens. Additionally, the use of an     oral rather than an infusional 5-fu regimen represents a clear advantage in terms of both     patient convenience and lack of associated catheter-related complications.   "
181038|NCT00205335|"     This study is designed to determine if there is an impact on blood glucose control in     patients who receive free test strips. Patients in the study have no insurance or insurance     that does not cover the purchase of test strips. A comparison of weight, blood pressure, and     Hemoglobin A1C from entry to the final visit will be used to compare patients' management of     their diabetes. Recommended values for these parameters will be used as the standard for     comparisons. The investigators anticipate that patients receiving free test strips will show     an improvement in the listed parameters as well as in satisfaction with their care.   "
181039|NCT00205348|"     To date, there have been no comprehensive studies on swallowing function in patients     undergoing surgery for multinodular goiter. We hypothesize that 1. Multinodular goiter has     significant effect on swallowing function in symptomatic and asymptomatic patients, which can     be demonstrated by a standardized questionnaire and a formal swallowing evaluation and 2.     Surgery will improve swallowing function as measured post-operatively by these same     parameters. Patients with multinodular goiter will be asked to fill out a validated survey     (SWAL-QOL) on swallowing function in addition to undergoing a formal swallowing evaluation     before and after surgery for multinodular goiter (subtotal thyroidectomy) and compared to     patients undergoing total thyroidectomy for follicular cancer and less extensive thyroid     surgery for other benign processes (lobectomy or lobectomy plus isthmusectomy).   "
181040|NCT00205361|"     The purpose of the study is to determine the variability of airway IgA levels in     anesthetized, well-nourished and malnourished patients undergoing elective general surgical     procedures and the effect of gender and race on this baseline variable. The hypothesis is     that airway IgA levels are lower in malnourished than in well-nourished patients.   "
181041|NCT00205374|"     Recurrent respiratory papillomatosis (RRP) is the most common benign neoplasm of the larynx     in the pediatric population. The impact of the disease on patients and families can be     tremendous due to the need for frequent treatment. It would be highly beneficial to develop     effective medical therapies as adjunctive measures to surgical ablation with the goal of     reducing the frequency of reoccurrence.   "
181042|NCT00205387|"     Cardiac elastography is a new technique to analyze strain and strain rates in many organ     systems, including the heart. In this study, cardiac elastography derived from the analysis     of raw radiofrequency data obtained from a conventional clinical echocardiograph system will     be compared to processed information that comes from the same echocardiograph system. The     purpose of this study is to determine if cardiac elastography can accurately determine strain     and strain rates as compared to more conventional means.   "
181043|NCT00205400|"     Hypothesis: Does the time spent within the target INR range differ when patients are managed     by AMD or IT models of anticoagulation care?      Experimental Design: The 36-month trial enrolled 192 eligible patients currently receiving     chronic warfarin therapy at the William S. Middleton Memorial VA Hospital. Consenting     patients are enrolled and randomized to 1 of 2 groups: usual clinic care with face-to-face     visits every 4 weeks (AMS model) or clinic visits every 3 months with interim laboratory     visits and telephone follow-up every 4 weeks (IT model). At study conclusion, the amount of     time the INR is within target range will be compared between the two groups. Thromboembolic     and bleeding event rates, patient knowledge, quality of life and healthcare utilization will     also be analyzed.   "
181047|NCT00205452|"     The only established treatment for the complete resolution of hyperparathyroidism is the     surgical removal of the affected glands. While proven as a means of resolving     hyperparathyroidism, there have been no comprehensive preoperative and postoperative     assessments to determine quality of life for patients undergoing minimally invasive vs.     traditional parathyroid surgery. Quality of life will be assessed in subjects undergoing     minimally invasive procedures and traditional procedures using a clinically validated survey.     We will gather data one week preoperatively as well as one week and one year postoperatively     then compare the survey results from the two study groups to each other. We will also compare     the study groups to a control group consisting of patients undergoing thyroid surgery. Our     ultimate goal is to clarify if minimally invasive parathyroid surgery techniques contribute     to a higher patient quality of life as compared to traditional techniques.   "
181048|NCT00205465|"     To evaluate the safety and tolerability of VX-765 in subjects with chronic plaque psoriasis     treated for 28 days.   "
181049|NCT00205478|"     The purpose of this study is to assess the clinical activity and safety of two doses of     VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.   "
181050|NCT00205491|"     The purpose of this study is to determine if treatment with venlafaxine reduces symptoms of     depression in persons with traumatic brain injury.   "
181051|NCT00205504|"     Oral contraceptives (OCs) are the most widely used method of reversible birth control.     However, the long-term cardiovascular safety of the widely used low-dose OCs     (ethinyl-estradiol < 50 mcg) is still debated. Although cardiovascular events are rare in     young women whether they use OCs or not, the risks of myocardial infarction and ischemic     stroke are increased among users of OCs who have conventional cardiovascular risk factors     such as use of tobacco, diabetes or hypercholesterolemia. However, the risk of cardiovascular     events in OC users with emerging cardiovascular risk factors (such as obesity and the     metabolic syndrome) have not been investigated. Recently, the metabolic syndrome has been     linked with the risk of cardiovascular disease. The syndrome is a clustering of risk factors     in a single individual, and its underlying cause may be insulin resistance. Whether the     metabolic syndrome predicts a higher cardiovascular risk in OC users has not been studied.     This is a critical problem because the metabolic syndrome is prevalent in 24% of adults.     Until the cardiovascular risks in users of OC are clearly defined, the appropriate use of OC     with the least harm would not be possible.      The investigator's long-term goal is to understand the best way to prevent and treat     cardiovascular disease in women. The objective of this particular project is to obtain pilot     data on the extent to which the metabolic syndrome and obesity affects glucose metabolism and     cardiovascular risks in women taking OCs. The researchers hypothesize that women with     metabolic syndrome and obese women will have worsened glucose metabolism and elevated     cardiovascular risks associated with OC use, when compared to normal weight women without the     metabolic syndrome. Results of this study will clarify the risk factors for cardiovascular     events in women taking OCs, and will serve as pilot data for a National Institutes of Health     (NIH) proposal. Once the cardiovascular risk factors of OC users are understood, clinicians     can make better informed decisions about contraceptive choices for their patients.   "
181052|NCT00205517|"     Certain methods of sedation increase the duration of respiratory failure. Two strategies, a     nursing- implemented sedation algorithm and daily interruption of sedatives, decrease length     of mechanical ventilation compared to conventional care but have not been compared to each     other. The reason certain methods of sedation lead to prolonged respiratory failure is     unknown but may be related to altered pharmacokinetics and dynamics that are unique to     critically ill patients. Critically ill patients receive substantial doses of sedatives over     prolonged periods. The impact of these management strategies on short- and long-term     psychiatric complications are unknown. The study seeks to test the central hypothesis that     sedation practices impact strongly on outcome of respiratory failure and psychiatric     complications. The three specific aims are (1) to compare two sedation strategies (protocol     directed sedation and daily interruption of sedatives), (2) to examine the prevalence of     psychiatric complications, and (3) to compute the pharmacokinetics of commonly used sedatives     and narcotics.      These aims will be achieved by enrolling critically ill patients in a prospective randomized     trial comparing the above mentioned sedation strategies, and assessing sedation level as well     as delirium throughout the duration of respiratory failure. Sedative plasma levels will be     measured, and pharmacokinetics computed. Psychiatric morbidity will be assessed by     administration of validated questionnaires.   "
181053|NCT00205530|"     To learn more about how a family treatment program helps people after brain injury.     Specifically, do families feel better and function better after going through the program,     and do patients feel better and function better after going through the program.   "
181054|NCT00205543|"     In this study we will examine whether suture repair of the palate, or roof of mouth, has any     effect on results of palate surgery performed for treatment of obstructive sleep apnea.   "
181055|NCT00205556|"     The purpose of this study is to compare the effect of low flux hemodialysis with online     hemodiafiltration on all cause mortality and a combination of cardiovascular morbidity and     mortality in chronic hemodialysis patients.   "
181056|NCT00205569|"     To learn more about behavior and everyday functioning after brain injury, and to learn if     behavior and functioning gets better with more education about changes after brain injury.   "
181057|NCT00205582|"     Excitatory amino acids may be involved in secondary neuronal damage after traumatic brain     injury. The amount of microglia activation is an indirect measure of neuronal damage.     Micorglia activation will be measured R)-[11C]PK11195 PET 1 week, 1 month and 6 months after     brain injury.   "
181058|NCT00205595|"     This is a study using Positron Emission Tomography (PET) to study the normal distribution of     the PET ligand (R)-[11C]PK11195. This ligand will be used to study inflammation in the brain     in several brain disorders like Alzheimer's disease and traumatic brain injury.   "
181059|NCT00205608|"     Patients with schizophrenia have volume loss in gray matter. This study is designed to     evaluate whether their is microglia activation in schizophrenia using [11C](R)-PK11195 PET.   "
181060|NCT00205621|"     In this study in-vivo quantification of amyloid load will be performed in patients with AD,     MCI and normal controls with Positron Emission Tomography. For this the PET tracers [11C]PIB     and [18F]FDDNP will be compared.   "
181069|NCT00205751|"     This is an international multi-center prospective, double randomized, open, controlled phase     III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide     plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma     patients.   "
181074|NCT00205816|"     The purpose of this study is to provide a mechanism for the emergency use of tigecycline in     the appropriate clinical situations.      The secondary objective is to evaluate the safety and efficacy of tigecycline in the     treatment of patients with selected serious infections where other treatment has not been     successful.   "
181061|NCT00205634|"     The purpose of this study is to evaluate whether Biaxin (clarithromycin) improves sputum     abnormalities, lung function, and overall feeling of well-being in people with cystic     fibrosis (CF). Biaxin is an antibiotic commonly used for the treatment of respiratory     infections in people who do not have CF, and is sometimes used in CF patients as well.     Studies done in a disease called diffuse panbronchiolitis (which is similar to CF) and some     preliminary studies that have been done in CF patients suggest that Biaxin might have a     beneficial effect on CF sputum in ways unrelated to its antibiotic activity.   "
181062|NCT00205647|"     This is a randonmized, masked, placebo-controlled parallel group, clinical trial to evaluate     the effects of three different doses of N-acetyl L-cysteine (NAC) and placebo on patient     safety and on physical and transport properties of expectorated sputum. Patient sumptoms,     quality of life and exacerbation will also be followed as well as pulmonary function testing     and functional exercise capacity. We hypothesized that a prolongeed course of oral NAC     favorably affects the morbidity of chronic bronchitis, particularly the incidence of acute     exacerbations.   "
181063|NCT00205660|"     This proposal aims to use well-validated methodologies such as dual energy x-ray     absorptiometry (DEXA), frequently sampled oral glucose tolerance tests (fsOGTTs), and     hyperinsulinemic euglycemic clamps to characterize the metabolic effects of 12 weeks of     aripiprazole treatment following chronic pretreatment with olanzapine, quetiapine,     risperidone or ziprasidone.      We hypothesize that switching to aripiprazole treatment will induce improvements in total     body adiposity, inflammation (e.g., high sensitivity C-reactive protein [hsCRP]), glucose     metabolism (e.g., insulin sensitivity) and lipid metabolism (e.g., fasting plasma     triglyceride), in comparison to chronic pretreatment with olanzapine, risperidone and     quetiapine.   "
181064|NCT00205686|"     DHEA or dehydroepiandrosterone is a naturally occurring hormone secreted by tghe adrenal     galnds. The secretion of HDEA declines with aging. DHEA is considered a food supplement and     it is not regulated by the FDA. The purpose of this research is to evaluate ceratin of the     biological effects of a reaplcement dose of DHEA. As you get older, DHEA levels are lower     than you were younger. The replamcent dose is the dose of DHEA that will raise DHEA levesl to     the levels found in young people. Anotehr purpose is to determine whether DHEA enhances the     adaptations to an exercise training program.   "
181065|NCT00205699|"     The prevalence of overweight and obesity, insulin resistance, hyperglycemia, dyslipidemia and     type 2 diabetes mellitus (T2DM) are increasing in children. Increased adiposity and related     reductions in insulin sensitivity are major risk factors for the development of     hyperglycemia, dyslipidemia, T2DM, and cardiovascular disease. Reductions in lifespan     attributable to obesity impact younger individuals most measurably. Antipsychotic medications     are extensively used in children, with certain agents producing greater increases in weight     and adiposity than other commonly used drugs in this age group. Increased use of atypical     antipsychotics in children has been stimulated by reported efficacy for behaviors such as     aggression that can occur in a variety of disorders. However, no previous randomized clinical     trial has sensitively quantified the metabolic effects of widely used atypical     antipsychotics. This study would address clinically relevant questions concerning both the     safety and efficacy of these agents in antipsychotic-naïve aggressive children with conduct     disorder, with permitted co-morbidity for a variety of psychiatric conditions including     attention deficit disorder, bipolar disorder, high functioning pervasive developmental     disorder, autism and schizophrenia. The project aims to describe and compare the outcome of     12 weeks of prospective, randomized treatment with olanzapine, risperidone or aripiprazole on     insulin action in skeletal muscle, liver and adipose tissue, insulin secretion, abdominal fat     mass, total body and fat-free mass, resting metabolic rates, efficacy for symptoms of     aggression and non-metabolic adverse events. Children aged 6-18 will be studied, exploring     effects of stimulant therapy and age-related differences in vulnerability to     treatment-induced adverse metabolic changes. Aims are addressed by measuring glucose and     lipid kinetics with stable isotope tracers, area-under-the-curve for post-load insulin and     c-peptide during frequently sampled oral glucose tolerance tests, body composition with dual     energy x-ray absorptiometry and magnetic resonance imaging (MRI), indirect calorimetry and     standardized assessments of efficacy and adverse events. Treatment effects will primarily be     analyzed using repeated measures analysis of covariance (ANCOVA), controlling for baseline     adiposity and other key risk variables. Relevant data are critically needed to target     clinical therapy and basic research, identify medical risks, and guide regulatory decisions     in this vulnerable population.   "
181066|NCT00205712|"     Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for     emergency sedation in children because it causes deep sedation with minimal respiratory     depression in comparison to other available agents. However, emergence reactions are an     important adverse effect of ketamine, characterized by transient changes in cognitive     function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral     effects are dose-dependently induced by ketamine and other antagonists of the     N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit     excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has     been proposed to explain key features of schizophrenia. Several treatments that block     excessive excitatory transmitter release have also been shown to prevent cognitive and     behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2     adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent     mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However,     this prevention strategy has not been evaluated in children. Children currently receive     clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an     important target for pharmacological strategies aimed at the prevention of schizophrenia.     This application proposes a double-blind, placebo-controlled, randomized trial to test the     safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in     preventing ketamine-induced mental symptoms in children. Planned primary analyses will     evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables     using analysis of variance (ANOVA). The proposed experiments are relevant to future     prevention trials for individuals at risk for schizophrenia, and to preventing adverse     effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).   "
181067|NCT00205725|"     Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in     individuals with schizophrenia than in healthy subjects or in other psychiatric conditions.     Antipsychotic treatment may contribute significantly to abnormalities in glucose regulation.     Hyperglycemia can contribute to long-term cardiovascular disease risk that may already be     increased in patients with schizophrenia due to higher rates of smoking, sedentary life     style, obesity and under-treated hypertension and dyslipidemia. This project will     characterize the effects on glucose control of the two most commonly prescribed newer     antipsychotic medications, ziprasidone and olanzapine, in patients with schizophrenia.   "
181068|NCT00205738|"     Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in     individuals with schizophrenia than in healthy subjects or in other psychiatric conditions.     Antipsychotic treatment may contribute significantly to abnormalities in glucose regulation.     Hyperglycemia can contribute to long-term cardiovascular disease risk that may already be     increased in patients with schizophrenia due to higher rates of smoking, sedentary life     style, obesity and under-treated hypertension and dyslipidemia. This project will     characterize the effects on glucose control of the two most commonly prescribed newer     antipsychotic medications, risperidone and olanzapine, in patients with schizophrenia.      This proposal specifically hypothesizes that olanzapine treatment will be associated with     decreases in insulin sensitivity (SI), without effects on insulin secretion.     Treatment-related effects on glucose effectiveness (SG) will be explored.   "
181076|NCT00205842|"     Patients undergoing major abdominal surgery are at highest risk for developing Postoperative     Ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal     distention and bloating, persistent abdominal pain; nausea and/or vomiting; variable     reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and     inability to tolerate a solid diet. This study will test the ability of alvimopan 12 mg given     30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function     in patients having partial small or large bowel resections.   "
181077|NCT00205855|"     There are many treatment options available for the management of chronic pain . Some include,     but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs,     Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks.     Historically, the mainstay of pain treatment has been pharmacotherapy. However,     pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable     side effects. Although many patients are successfully treated, for those who fail some of     these more conservative therapies the remaining option is limited to spinal cord stimulation     (SCS), proven to be an effective therapy to more than half of those failing conservative     treatments . Over 50% of those who have failed these more conservative methods of pain     management, can now, under the guidance of a clinician utilizing SCS, have their pain levels     successfully managed. SCS is a less invasive therapy that is a reversible treatment with     greater long-term benefits than more permanent, radical approaches and one that deserves     greater consideration in the management of chronic, intractable pain.   "
181078|NCT00205868|"     The purpose of this study is to assess the acute and chronic effectiveness of the Advanced     Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery     syndrome and associated low back axial pain.      Subjects will undergo a temporary or permanent trial to assess their candidacy for placement     of an implantable pulse generator. Those who demonstrate a significant clinical reduction in     pain will be enrolled in the chronic study. Subjects will be followed for 12 months post     implantation to assess the long-term effectiveness of the therapy.   "
181079|NCT00205881|"     Normal hearing listeners gain important everyday benefits from listening with two ears     (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of     bilateral hearing include the ability to determine where sounds are coming from and the     ability to hear sounds and understand speech in noisy environments. Based upon these     advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants     (one in each ear) and (2) compare HiResolution sound processing with conventional sound     processing.   "
181080|NCT00205894|"     The purpose of this study is to evaluate the safety and efficacy of a implantable device,     called the bion(R), in the treatment of chronic headache. The bion microstimulator is placed     underneath the skin next to the greater occipital nerve. The bion microstimulator then     stimulates the nerve by generating small amounts of electrical current.   "
181081|NCT00205907|"     The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in     patients with advanced emphysema.   "
181082|NCT00205920|"     The purpose of this study is to determine the effective dose of the Aeris BLVR System in     patients with advanced emphysema.   "
181083|NCT00205933|"     The purpose of this project is to use behavioral techniques to investigate emotional     processing in subjects with major depression and healthy comparison subjects.   "
181084|NCT00205946|"     The purpose of the study is to evaluate the effects of a single-dose of Wellbutrin XL     (bupropion hydrochloride) on reward processing.   "
181085|NCT00205959|"     The aim of the study is to compare the results regarding fracture healing      and functional outcome after the treatment of proximal humeral fractures      with the four different treatment methods after 12w./6months and 12 months      based on radiological evaluation as well as the constant score and the      neer score.   "
181086|NCT00205972|"     The aim of the study is to radiologically compare the fracture healing as well      as the functional treatment outcome of conservative and operative treatment of      defined humerusshaft fractures after 6w./12w./and 12 month based on the      modified constant score.   "
181087|NCT00205985|"     The aim of this study is to compare the time to return to previous activity      level between operative treatment and non-operative cast immobilization of      patients with an acute complete fracture of the middle part of the scaphoid,      without any dislocation or comminution visible CT-scan.   "
181088|NCT00205998|"     Primary objective of the study is to demonstrate specific indications for the      surgical treatment of distal radius fractures using the locking compression      plate.   "
181089|NCT00206011|"     This study is a comparison of open surgery versus an endoscopic approach in condylar neck     fractures; it will look at functional outcome, cosmetic outcome and patient satisfaction.   "
181090|NCT00206024|"     This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to     investigate the relationship between dose of esomeprazole magnesium and acid-associated     heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole     magnesium in doses up to 40 mg BID will also be assessed.   "
181091|NCT00206037|"     The aim of this RCT is to show, that in a patient group receiving COLLOSS E combined with     TomoFix for medical open wedge high tibial osteotomy, the onset of bone healing is earlier in     time, compared to patients receiving TomoFix without COLLOSS E.   "
181092|NCT00206050|"     This Phase IV study is intended to compare intragastric acid suppression of oral esomeprazole     (NEXIUM ® Delayed-Release Capsules) with that of oral pantoprazole (PROTONIX ® Delayed     Release Tablets ), in subjects who continue to require acid-suppressive therapy following a     course of intravenous (iv) pantoprazole (PROTONIX ® I.V. for Injection).   "
181094|NCT00206076|"     The purpose of the study is to assess the safety and efficacy of mycophenolate mofetil alone,     or with reduced dose cyclosporine (CsA) or tacrolimus, for immunosuppression long-term after     liver transplantation, in an attempt to reduce the potential side effects from using     cyclosporine or tacrolimus.   "
181095|NCT00206089|"     This study is being carried out to study the efficacy and safety of treatment with melagatran     injection followed by ximelagatran tablets in preventing blood clots, compared with     enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be     done approximately 6 months after the surgery.   "
181097|NCT00206115|"     The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained     Release (SR) is more effective than placebo in the treatment of acute schizophrenia.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
181098|NCT00206128|"     The purpose of this study is to determine that the efficacy of the sustained release (SR)     formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR)     formulation.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
181099|NCT00206141|"     This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in     treating bipolar depression during an 8-week acute phase compared with placebo and lithium,     followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel)     compared to placebo.   "
181100|NCT00206154|"     The purpose of this study is to compare a combination asthma drug (Symbicort) with its two     components, budesonide and formoterol, taken individually or in combination, and with placebo     in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease     (COPD)   "
181101|NCT00206167|"     The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler     (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with     chronic obstructive pulmonary disease (COPD).   "
181102|NCT00206180|"     The purpose of this study is to decide if controlling stomach acid is related to healing of     erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg     once daily.   "
181103|NCT00206193|"     The purpose of this study is to determine which medical treatment is the most effective to     terminate a pregnancy.   "
181104|NCT00206206|"     In response to the evidence supporting “tight” glucose control (70 – 110) in the critical     care setting, the MMH ICU developed a protocol utilizing regular intravenous insulin. This     protocol was initiated in 2002. Monitoring of the data collected revealed effective glycemic     control when this protocol was used. However, limited utilization has led to overall     ineffective glycemic control in this ICU. The poor utilization is largely due to a general     reluctance of physicians to start their patients on an intravenous insulin infusion. As     contributing to this poor compliance is the “open” nature of the ICU. The MMH ICU is an     “open” ICU, meaning that many physicians across multiple subspecialties admit to this unit.     Approaches to controlling hyperglycemia vary greatly, depending largely upon the treating     physician. In an attempt to improve overall glycemic control in this “open” ICU, the     Subcutaneaous Insulin Aspart Hyperglycemia Protocol (SIAP) was developed which incorporates a     subcutaneous insulin aspart regimen that triggers the use of a regular insulin infusion     protocol when the SIAP is not adequately controlling the patient’s blood glucose.      This study aims to evaluate 1) the effect the SIAP on overall glycemic control in the ICU, 2)     the effectiveness that the SIAP has on controlling blood glucose as compared with past     practices using regular insulin, and 3) the effect the SIAP has on patient complications and     outcomes in the MMH ICU.   "
181105|NCT00206219|"     This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer     in terms of overall survival.   "
181106|NCT00206232|"     The purpose of the study is to collect information about the potential benefit and safety of     low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine     whether spironolactone can cause the patient's condition to improve.   "
181107|NCT00206245|"     The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and     75 mg).      The secondary objectives are to compare the efficacy between the three doses of AZD0865 and     esomeprazole 40 mg and to evaluate the safety and tolerability of AZD0865.   "
181108|NCT00206258|"     The purpose of this study is to see if giving pramlintide and insulin before a meal would     lower high blood sugar and if a glucagon (a naturally made hormone in the body but reduced in     diabetes and its role is in prevention of low blood sugar) shot given in the late after     meal time would prevent low blood sugar. The studies outlined in this proposal might help in     developing new treatment options to target after meal high blood sugar and before meal low     blood sugar in children. This would possibly help improve overall blood sugar control and     prevent the long-term complications of diabetes.   "
181109|NCT00206271|"     Background: Long-lasting pain and disability, known as chronic whiplash-associated disorder     (WAD), may develop after forced flexion-extension trauma to the cervical spine. Mechanisms     behind WAD are virtually unknown, as are the possible effects of early intervention. This     trial was undertaken to compare the effect of three early intervention strategies for the     prevention of developing chronic WAD following acute whiplash injury.      Methods: 458 participants were randomised to one of 1) stiff neck collar, 2) advice to     act-as-usual, or 3) an active mobilisation regime. Participants were followed for one year     and treatment effects were compared in terms of lasting neck pain, headache, disability and     sick-leave.   "
181110|NCT00206284|"     The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and     75 mg). The secondary objectives are to compare the efficacy between the three doses of     AZD0865 and esomeprazole 20 mg and to evaluate the safety and tolerability of AZD0865.   "
181131|NCT00207025|"     The purpose of this clinical research study is to learn about the safety and tolerability of     daily BMS-275183 in patients with advanced cancer.   "
181111|NCT00206297|"     The purpose of this study is to see if reducing the dose of insulin before a meal and giving     both pramlintide and insulin as dual wave infusions will lower the chance of low blood sugars     after a meal. In addition, the study will look at giving pramlintide as a basal infusion (a     very low steady dose) for several hours   "
181112|NCT00206310|"     The purpose of the study is to investigate if rosuvastatin, added on top of all other     medicines prescribed to subjects with symptomatic systolic heart failure, reduces the     combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal     stroke (time to first event)   "
181113|NCT00206778|"     We are comparing the efficacy of Lamotrigine to that of Standard of Care Sodium Valproate for     the treatment of Mixed Mania. The study hypothesis is that Lamotrigine will be more     efficative for treating mixed mania in patients with Bipolar Disorder.   "
181114|NCT00206791|"     The purpose of this non-comparative study is to test, for the first time, the bioactivity of     a new “ready to use” calcium phosphate biomaterial in fillings of little losses of osseous     substance from various origins, such as traumatic and benign tumoral causes.   "
181115|NCT00206817|"     This clinical trial is being conducted to 1) evaluate the possible usefulness of a panel of     cardiac markers in assessing emergency department patients with possible acute coronary     syndrome, 2) evaluate the usefulness of BNP in assessing emergency department patients with     possible acute coronary syndrome, 3) determine if BNP can be used to predict adverse events     during hospitalization and in the emergency department, and 4) evaluate how a Point-of-Care     testing platform affects resource utilization in the emergency department.   "
181116|NCT00206830|"     SHORTIE is a two-phase study to determine the impact of the Triage Profiler S.O.B. (Shortness     Of Breath) Panel on patient management, outcome, and cost.   "
181117|NCT00206843|"     The purpose of this study is to test whether physicians can make more informed treatment,     admission, and discharge decisions related to patient care by having serial Triage® BNP test     results available to assess disease severity, while patients are being treated for HF in the     Emergency Department and/or during their admission. This is believed to lead to a better     outcome as well as more efficient and cost-effective treatment.   "
181118|NCT00206856|"     To determine the clinical utility of using the Triage® BNP Test to guide therapy in     outpatients with heart failure   "
181119|NCT00206869|"     The purpose of the study is to evaluate the effect of exercise and heat on the light     sensibility of patients with erythropoietic protoporphyria   "
181120|NCT00206882|"     The purpose of the study is to evaluate the sun protection effect and efficacy in treatment     of sunburn using topical corticosteroids in a randomised controlled and investigator blinded     trial.   "
181121|NCT00206895|"     The purpose of the study is to evaluated the efficacy and tolerability of methyl     aminolevulinate and 5-aminolevulinic acid photodynamic therapy in patients with moderate to     severe facial acne vulgaris in a randomized controlled and investigator blinded trial.   "
181122|NCT00206908|"     This project is designed to evaluate the clinical utility of a novel blood test, the Triage     Stroke Panel, as an aid in the diagnosis and assessment of stroke. The Triage Stroke Panel     test device, used with the Triage MeterPlus, is a rapid, point-of-care immunoassay. The test     measures the concentration of various analytes present in EDTA-anticoagulated whole blood or     plasma, specifically B-type natriuretic peptide (BNP), fibrin degradation products containing     D-Dimer, matrix metalloproteiase-9 (MMP-9), and S-100B. The test utilizes a proprietary     algorithm for the automatic calculation of a single Multimarker Index (MMX) result from the     individual biomarker values. The MMX result is being evaluated for use as an aid in the     assessment and diagnosis of stroke.   "
181123|NCT00206921|"     The purpose of the study is to compare efficacy and adverse effects of pulsed dye laser and     intense pulsed light in patients with skin telangiectasia and redness.   "
181124|NCT00206934|"     It is of great clinical relevance to know if selective serotonin re-uptake inhibitors affect     information processing. Our hypothesis was that aspects of information processing would be     disturbed whereas others would improve.   "
181125|NCT00206947|"     The present study will specify and delineate the separate components of cognitive deficits     and examine the effects of adjunctive cholinergic augmentation on these cognitive deficits as     well as psychopathology in schizophrenic patients treated with an antipsychotic compound with     no aberrant binding affinity for the cholinergic receptor system. The hypothesis is that     cholinergic augmentation using donepezil will improve cognitive deficits, sensory gating     deficits, and psychopathology in schizophrenic patients treated with an atypical     antipsychotic (ziprasidone).   "
181126|NCT00206960|"     We wanted to compare dopamine D2 receptor activity, brain structure, brain function, sensory     gating and cognition in neuroleptic-naive schizophrenic patients and matched healthy     controls. Additionally, we wanted to examine the effects of 3 months of treatment with either     low doses of a typical or an atypical antipsychotic compound on the same functions. The     hypotheses were that schizophrenic patients suffered from disturbances in brain function and     structure, information processing, and extrastriatal D2 receptor activity, and that these     disturbances would be related to each other and to psychopathology. Additionally, we expected     the atypical compound to have an effect on some of the disturbances in information     processing, and that the atypical compound - in contrast to the typical drug - would show     extrastriatal over striatal selectivity.   "
181127|NCT00206973|"     Study on the relationship between the response of the airways to a bronchial provocation test     with mannitol and the degree of airway inflammation in asthma patients.   "
181128|NCT00206986|"     The investigators want to try to improve information processing in schizophrenic patients via     pharmacological intervention. The hypothesis is that decreased noradrenergic activity will     normalize information processing (PPI, P50 gating, P300, and mismatch negativity) in patients     with schizophrenia.   "
181129|NCT00206999|"     We wanted to compare the relation of two different psychophysiological paradigms (PrePulse     Inhibition of the startle response = PPI and P50 suppression) to each other. Additionally, we     wanted to test the effect of the combined serotonin- and noradrenaline re-uptake inhibitor,     imipramine, on these measures. The primary hypothesis was that PPI and P50 gating would not     correlate with each other at baseline. The secondary hypothesis was that increased     noradrenergic and serotonergic activity would disrupt PPI as well as P50 gating.   "
181132|NCT00207038|"     Studies have shown that the prevalence of respiratory symptoms, airway hyperresponsiveness     (AHR) and asthma is high and increasing in elite athletes. The inflammation seen in the     airways of elite athletes might differ from the inflammation seen in the airways of     ordinary asthmatics and it might represent a different kind of asthma.      The primary purposes are        1. To investigate the type of airway inflammation in young swimmers.        2. To investigate the acute changes in airway inflammation after a short training session.   "
181133|NCT00207051|"     This is a phase I dose escalation study to determine the safety, pharmacokinetics and     pharmacodynamics of BMS-582664 in combination with full dose erbitux in patients with     advanced colorectal cancer who have received no more than 2 prior regimens for metastatic     colorectal cancer.   "
181134|NCT00207064|"     We want to relate disturbances in first-episode schizophrenic patients in serotonin 5-HT2A     receptors, brain structure, brain function, and information processing to each other and to     psychopathology. Additionally, we want to examine the influence of 5-HT2A receptor blockade     on these disturbances. We expect disturbances in the serotonergic system at baseline to     correlate with specific structural and functional changes and with disruption in information     processing as measured with psychophysiological and neurocognitive methods - and we expect     5-HT2A receptor blockade to reverse some of the functional and cognitive impairments. We do     not expect any effect of treatment on brain structure   "
181135|NCT00207077|"     The purpose of this study is to find a safe and effective dose of the combination of     cetuximab (Erbitux) and Tarceva (erlotinib).   "
181136|NCT00207090|"     The purpose of this study is to test how rifampin affects the removal of BMS-247550     (ixabepilone) from the body.   "
181137|NCT00207103|"     This is a Phase I dose escalation study to determine the safety, pharmacokinetics and     pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.   "
181138|NCT00207116|"     The purpose of this study is to predict responses to Erbitux as a single agent in patients     with Non Small Cell Lung Cancer   "
181139|NCT00207129|"     The purpose of this study is to test how BMS-247550 (ixabepilone) affects the removal of     capecitabine from the body and how capecitabine affects the removal of BMS-247550 from the     body.   "
181140|NCT00207142|"     The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load     < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an     initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART     regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous     NRTI backbone.   "
181141|NCT00207155|"     The purpose of this study is to predict response to Erbitux as a single agent in patients     with metastatic colon cancer   "
181142|NCT00207168|"     To assess compliance of once daily dosing to assess their benefits in terms of potency and     safety as well as their impact on adherence and quality of life.   "
181143|NCT00207181|"     The purpose of this study is to develop a tool that can more accurately assess the intensity     and kind of physical activity that a person performs. The experimental tool, which will use a     mobile computing device as a way of automatically identifying when a certain activity is     being performed and at what intensity, will be tested against a self reported paper diary of     activities performed on a day to day basis. It is hoped that this study will increase     understanding of the health benefits of certain types of physical activity performed in the     home.   "
181144|NCT00207194|"     The aim of this study is to assess the efficacy of Telephone-Linked_Care for Hypertension     Regimen Adherence in an African American population (TLC-HTN-AA). TLC-HTN-AA is a     computer-based telecommunication system that will monitor, educate and counsel African     American adults with hypertension on adherence to medication, diet, and exercise. The primary     hypotheses are:        1. TLC-HTN-AA use will improve medication regiment adherence        2. TLC-HTN-AA will improve adherence to 3 healthy diet recommendations        3. TLC-HTN-AA will improve levels of regular exercise        4. Patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target          regiments than patients in the control group   "
181145|NCT00207207|"     The objective is to assess the effect of using ASBG (alternate site blood glucose) versus     FTBG (finger tip blood glucose) testing on long-term glycemic control in diabetics. Since     ASBG measurements appear to lag behind FSBG measurements at times of changing glucose     concentration, it is possible that ASBG measurements will yield lower postprandial readings     than FTBG, potentially causing a negative impact on long-term control. It is also possible     that since ASBG is reportedly more comfortable than FTBG testing, it's use might improve     adherence to testing and improve long term control.   "
181146|NCT00207220|"     This study will test the hypothesis that increases in ventricular-vascular stiffness can be     demonstrated by arterial tonometry and echocardiography in subjects with heart failure with     preserved ejection fraction (HF-nlEF)(i.e. normal left ventricular function.) We will also     track changes in pulsatile hemodynamics over time in subjects hospitalized with HF-nlEF.   "
181147|NCT00207233|"     Phase I, 6 weeks: Intensive weight loss 42 obese subjects with type 2 diabetes mellitus or     impaired fasting glucose (FBS greater than 100 mg/dl) and a patient at the Nutrition and     Weight Management Center at Boston Medical Center will be randomized to receive either an     MCT-based or LCT-based liquid diet for a 6 week period (Phase I) to establish compliance     followed by a second 6 week period (Phase II). These diets will be isocaloric (1083 kcal/day)     and identical except for the quality of the fat. The intervention will be double blinded. The     MCT diet will consist of 5 liquid meals using a commercial product plus 34 grams MCT oil     (Life Enhancement Products, Inc. Petaluna, CA; 8.3 kcal/gm) added per day to the HMR shakes.     The LCT diet will utilize 5 HMR shakes plus 31.5 grams LCT oil (corn oil; 9 kcal/gm) per day.     Patients in both groups will be given a list of supplemental foods that are suitable for the     study. They may choose to eat up to an additional 400 kcal per day from this list and will be     asked to add these to their food records for monitoring of their caloric intake. A dietitian     will instruct subjects at a baseline visit on behavior modification and a moderate physical     activity program. Baseline testing includes the following: Body composition by DEXA     (Hologic); Subcutaneous abdominal adipose tissue biopsy; blood work. Subjects who do not lose     5% of their baseline weight by the end of Phase I will be withdrawn from the study. If     subjects do not lose 5% in Phase I, they will be considered inappropriate for a liquid diet,     and therefore for the study, and will be discontinued from the study.      Phase II, 6 weeks: Continued weight loss program during phase II, subjects will be maintained     on the same diet, supplements and exercise program. Once patients enter Phase II, all     baseline lab measurements will be repeated. Needle biopsies of subcutaneous abdominal adipose     tissue will be obtained at the beginning and at at the end of Phase II. Finger-stick blood     glucose levels will be checked weekly. At the end of Phase II, and of the study, fasting     blood work will be obtained. At the end of Phase II, the following procedures will be     performed: Subcutaneous abdominal adipose tissue biopsy (total = 3). Body composition by DEXA     (Hologic) (total = 2).   "
181997|NCT00227929|"     This study will evaluate the effectiveness of culturally sensitive treatment versus regular     care in treating depressed Chinese Americans.   "
181156|NCT00207363|"     The purpose of this study is to see which of two doses of PEG (polyethylene glycol)     interferon alfa-2b in combination with Ribavirin for 48 weeks is more effective at     elimination of hepatitis C.      The primary objective of this study is to compare the efficacy of Induction PEG-Interferon     alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron)     and Ribavirin (Rebetol) in patients with chronic hepatitis C.   "
181157|NCT00207376|"     This is a prospective multicenter clinical study to evaluate the safety and effectiveness of     an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent     foramen ovale (PFO).   "
181148|NCT00207259|"     Randomized clinical study of two CAM therapies, 1) Reiki and 2) Relaxation Response Therapy     with Cognitive Restructuring counseling (RRT with CR), compared to an education-only control     arm in patients about to begin an eight-week course of external beam radiotherapy (EBRx) for     prostate cancer.      Generally, we would like to examine the feasibility of studying Reiki and RRT with CR in     patients with prostate cancer, and to obtain preliminary results on the effectiveness of     these treatments compared to controls.      Specific objectives:        1. Determine the proportion of eligible patients who agree to participate in the study        2. Measure compliance with CAM therapy interventions        3. Measure compliance with physiologic and psychological outcome measurement assessments        4. Assess differences between experimental and control groups on measures on depression,          anxiety, quality of life, salivary cortisol levels and an immunomarkers   "
181149|NCT00207272|"     Twelve obese patients approved for gastric bypass surgery will be randomized to either     receive an MCT-based or LCT-based liquid diet for a 4 week period. These diets will be     identical except for the quality of the fat. The intervention will be double-blinded. Six     patients will receive a daily diet consisting of 5 liquid meals using the HMR 800 meal     replacement product (Health Management Resources, Inc; 160 calories/shake) with 44.5 grams     MCT oil (Life Enhancement Products, Inc., Petaluna, CA; 8.3 kcal/gm) added. Six patients will     receive the same HMR diet but with 41 grams LCT oil (corn oil; 9 kcal/gm) added. Patients in     both groups will be given a list of supplemental foods that are suitable for the study. They     may choose to eat up to an additional 700 kcal per day from this list and will be asked to     complete food records for monitoring of their caloric intake. Patients will undergo gastric     bypass surgery after 4 weeks of being on their diets. Patients in both groups will be seen     weekly by a registered dietitian and a physician. Blood pressure and weight will be recorded,     and any adverse events will be noted and cared for as is appropriate. Dietary instruction     will be reviewed as needed.Both diets will be 1170-1870 kcal/day, consisting of 36% CHO,     26.2% protein, and 37.6% fat. The MCT diet will contain 30.2% of total calories at MCT oil.     The percentages given are based on the shake and oil consumption only (1170 kcal/day). The     remainder of the diet will vary according to patients' selections from the list of permitted     foods, up to an additional 700 kcal/day (for the total 1870 kcal/day). All subjects will     receive a multi-vitamin each day. Subjects will also receive two Fibercon capsules per day to     prevent possible bowel changes associated with being on a full liquid diet. During surgery,     biopsies of visceral and omental adipose tissue, as well as subcutaneous abdominal adipose     tissue, will be obtained. Tissue will be analyzed to determine mRNA levels of key enzymes in     fatty acid esterification, lipolysis, and oxidative disposition. This preliminary phase will     be conducted to determine whether visceral, omental, and subcutaneous abdominal adipose     tissue behave similarly when exposed to an MCT-based diet.   "
181150|NCT00207285|"     The purpose of the study is to test the effect of a sleep disorders detection and treatment     program for police officers on their safety, quality of life, and job performance. The     program is called Operation Healthy Sleep. We will develop and test a sleep health detection     and treatment program that we aim to apply nationwide to reduce police officer fatigue and     stress; enhance the ability of officers and their families to cope with police work; improve     the health, safety and performance of law enforcement officers; and thereby improve public     safety. Part of this program will include a questionnaire asking about about work hours and     health related issues. We will then look at how these survey data relate with data on police     officer safety and job performance that we are collecting through police department's     databases.      Sleep disorders are common and treatable, but often remain undiagnosed and untreated. Police     officers work some of the most demanding schedules known, which increases their risk of sleep     disorders. The public expects officers to perform flawlessly, but unrecognized sleep     disorders lead to severe disruption of sleep, which significantly reduces an individual's     ability to think clearly and perform well. In addition, sleep loss and sleep disruption     affect personal health, increasing the risk of gastrointestinal and cardiovascular. We also     know that sleep loss increases the risk of injury due to motor vehicle crashes.      The goals of Operation Healthy Sleep are to improve officers' health, safety, and performance     by reducing the impact of fatigue.      The study will take place over two years. In the first year, half of the police officers will     take part in Operation Healthy Sleep, and in the second year, the second half will     participate. We will carefully select the year 1 and year 2 groups so that the data collected     across the two years can be validly compared.   "
181151|NCT00207298|"     Positron emission tomography (PET) is a nuclear medicine procedure based on the measurement     of positron emission from radiolabelled tracer molecules. These radiotracers allow biologic     processes to be measured and whole body images to be obtained which demonstrates sites of     radiotracer accumulation. The most common radiotracer in use today is 18F-fluorodeoxyglucose     (18F-FDG) which is a radiolabelled sugar (glucose) molecule. Imaging with 18F-FDG PET is used     to determine sites of abnormal glucose metabolism and can be used to characterize and     localize many types of tumours.      Cancer treatment and outcome depend largely on the accurate diagnosis and staging of disease.     There is extensive data in the literature indicating the importance of FDG-PET imaging in     accurately characterizing disease, as well as determining stage and sites of recurrent     disease in many cancer types. For these indications, functional imaging with PET provides     unique information which is not available from standard medical imaging modalities such as     ultrasound, X-ray, computerized tomography (CT) or magnetic resonance imaging (MRI).      The objectives of this study are to document the safety and efficacy of 18F-FDG produced by     the British Columbia Cancer Agency (BCCA) at its Tri-University Meson Facility (TRIUMF)     production facility and to evaluate FDG-PET as a diagnostic and decision making tool in the     management of oncology patients in British Columbia. With a population base of over 4 million     people, standardized cancer treatment protocols, and evidence based guidelines for FDG-PET     imaging, the BCCA is positioned to make an important contribution to defining the role of PET     in the Canadian health care system.   "
181152|NCT00207311|"     This is a prospective, multi-center, randomized, placebo-controlled trial in subjects with     histological evidence of > 33% hepatic steatosis or nonalcoholic steatohepatitis (NASH) and     chronic hepatitis C. Patients who have not been previously treated for hepatitis C (treatment     naive) will be enrolled.   "
181153|NCT00207324|"     The hypothesis is that silver leaf nylon dressing reduces the percentage of patients     developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy.     The secondary hypothesis is that silver leaf nylon dressing reduces breast-related symptoms     of pain, itching and burning sensation in patients receiving whole breast radiotherapy.   "
181154|NCT00207337|"     Current treatment for emphysema is limited to measures that include inhaled oxygen,     bronchodilators, anti-inflammatory drugs and pulmonary rehabilitation. Highly invasive     procedures such as lung volume reduction surgery or lung transplantation are also performed.     Treatment using the Exhale Drug-Eluting Stent (DES) is a minimally invasive bronchoscopic     treatment that has the potential to reduce shortness of breath in emphysema patients. This     study tests the safety and effects of Exhale DES in the treatment of patients with emphysema.   "
181155|NCT00207350|"     The researchers' specific aims are to test the following hypotheses:      Hypothesis 1: A tumor can be completely ablated by ILT with MRI-guidance.      Hypothesis 2: The MRI-based 3D temperature map of tissue during ILT is predictive of     destruction.      Hypothesis 3: The 3D thermal dose map that is based on the tissue's temperature over time     is more predictive of tissue destruction than the temperature map.   "
181482|NCT00217919|"     The purpose of this study is to compare a health-counselor mediated telephone counseling     intervention to usual care to reduce low density lipoprotein cholesterol (LDL-C) levels in     patients with peripheral arterial disease (PAD).   "
181158|NCT00207389|"     Obesity is a multinational epidemic. There is evidence that despite educational measures and     increased public awareness, the number of obese individuals continues to increase. Of the     numerous obesity-related comorbidities, type 2 diabetes remains one of the most significant     in terms of mortality and health care costs. Gastric Bypass Surgery (GBS) not only offers an     effective form of therapy for morbid obesity, but also amelioration of type 2 diabetes     mellitus. The normalization of glucose levels in GBS patients occurs within days after     surgery and has been shown in surgical literature to be independent of the weight loss after     surgery. The proximal gut, the site of release of certain incretins, may play a role in     glucose homeostasis in obese individuals with type 2 diabetes mellitus. One such incretin is     GIP, which when released into the circulation during the immediate postprandial period,     accentuates the insulin response to a glucose meal. It is hypothesized that overactivity of     this enteroinsular axis in obese individuals produces cell resistance to insulin and     subsequent type 2 diabetes mellitus. A previous study reported elevated fasting GIP levels,     as well as an exaggerated GIP response to a glucose meal, in obese subjects, which was     significantly reduced months after GBS following weight loss. This pilot study of obese     patients scheduled for GBS will compare the serum levels of certain peptides, including GIP,     following a glucose meal before and after GBS, before weight loss has occured. In order to     reproduce the preoperative state, and therefore to demonstrate the physiologic change, a     small group of subjects who undergo open surgery will undergo the same measurements after     surgery, but using a model in which the meal traverses the stomach, duodenum and jejunum with     the aid of a gastrostomy tube.   "
181159|NCT00207402|"     Genotype 1 hepatitis C virus (HCV) patients who did not respond (did not lose virus during     treatment) or relapsed (virus went away on treatment but came back after treatment was     stopped) after treatment with at least twelve weeks of a pegylated (long-acting) interferon     and ribavirin will be considered for this study. There are two purposes to this study: first,     to determine how rosiglitazone, a medicine used to treat diabetes, affects the HCV viral     load; and second, to determine if treatment of insulin resistance with rosiglitazone prior to     therapy for HCV will improve sustained virologic response (loss of virus that continues     beyond six months after completion of HCV therapy) to HCV therapy.   "
181160|NCT00207415|"     The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease     Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other     chronic diseases. In some locations it may be more feasible to combine efforts and offer the     generic course rather than the arthritis-specific program. However anecdotal evidence has     questioned whether people with arthritis obtain as much benefit from the more generic course     as they do the arthritis-specific course. The primary purpose of this research study is to     compare health outcomes among people with arthritis who participate in either ASHC or the     CDSMP. The University of Illinois Project is emphasizing recruiting a balance of uran and     rural participants. The results of this research will be used to guide Arthritis program     recommendations on the use of ASHC and CDSMP to improve the quality of life for people with     arthritis.   "
181161|NCT00207428|"     The purpose of this study was evaluation the efficacy of antiepileptic drug carbamazepine in     the treatment of mild-to-severe bronchial asthma.   "
181162|NCT00207441|"     The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease     Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other     chronic diseases. In some locations it may be more feasible to combine efforts and offer the     generic course rather than the arthritis-specific program. However anecdotal evidence has     questioned whether people with arthritis obtain as much benefit from the more generic course     as they do the arthritis-specific course. The primary purpose of this research studies is to     compare health outcomes among people with arthritis who participate in either ASHC or the     CDSMP. The North Carolina project is focusing primarily on African Americans from 6 rural     counties in North Carolina. The results of this research will be used to guide Arthritis     program recommendations on the use of ASHC and CDSMP to improve the quality of life for     people with arthritis.   "
181163|NCT00207454|"     This research tests the effectiveness of a social cognitive intervention (with option of     patient-delivered medication) geared toward increasing patient referral of partners.   "
181164|NCT00207467|"     The goal of this study was to examine the efficacy of patient-delivered partner treatment     (PDPT) compared to standard partner referral (PR) and booklet enhanced partner referral     (BEPR).   "
181165|NCT00207480|"     This study will implement and test a brief, tailored individual-level intervention to be used     in two New Orleans adolescent clinics with female patients aged 16-24 who douche.   "
181166|NCT00207493|"     Patients diagnosed with chlamydial infections (a sexually transmitted disease) are asked to     notify their sex partners and tell them to seek medical evaluation. This project tests an     enhancement to the materials provided to patients to help convince their partners to seek     evaluation against the standard of care, which is a brief notification instruction. The     desired outcomes are greater levels of notification by participants of their partners and     lower levels of reinfection among participants.   "
181167|NCT00207506|"     Non-professional community leaders may be at a great advantage in reaching otherwise hard to     reach populations for the purpose of advising on sexually transmitted disease (STD)     prevention (lay health advisors), health care access, and model health behavior. Latino     migrant farm workers are at increased risk for STD and might benefit from such lay health     advisors. The study will examine whether this strategy is a useful one for STD prevention in     Latino migrant farm workers in rural and small town areas of North Carolina.   "
181998|NCT00227942|"     This study will evaluate the effectiveness of estrogen replacement therapy in treating     depression in menopausal women with hot flashes and insomnia.   "
181225|NCT00208273|"     This trial will compare grade 2 or greater late skin toxicities of concomitant     letrozole-radiotherapy and radiotherapy followed by letrozole as adjuvant therapy for     postmenopausal women with receptor (estrogen receptor [ER] and/or progesterone receptor     [PgR]) positive tumors. Each drug will be prescribed for 5 years.   "
181398|NCT00216801|"     This pilot study will explore the relationship of Ochratoxin A (OTA) levels in patients with     upper tract transitional cell (TCC), renal cell, and testicular cancers by measuring levels     of OTA in serum and tumor samples. Dietary exposure will also be analyzed.   "
181168|NCT00207519|"     In this 3-month pilot study, we will introduce to 40 adolescents at risk for overweight     (i.e., a BMI/age >85th percentile) a structured meal plan consisting of meal replacements,     fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and     invite at least one parent to the scheduled visits, however, no subject will be eliminated     because of lack of parental involvement. In this study, we will conduct behavior modification     group sessions using lessons which are structured and patterned after the suggestions     documented in the LEARNÒ Program for Weight Control. Diet instruction by a registered     dietitian will include the appropriate use of meal replacements for a low-fat, low-calorie     meal plan. Portion sizes of all foods recommended will be reviewed and a structured meal plan     will be developed by the dietitian for subjects to follow.      Subjects will return on a weekly basis for behavioral modification groups sessions in     conjunction with the liquid meal replacement diet. Blood work and physical examinations will     occur pre and post intervention.   "
181169|NCT00207532|"     CDC staff at the National Center on Birth Defects and Developmental Disabilities have been     working closely with a Honduras-based organization, Project Healthy Children (PNS) and the     Ministry of Health, on a folic acid supplementation study among female maquila workers.     Participants are divided into two groups. One group receives a 1.0 milligram pill daily while     the other group receives a 5.0 milligram pill weekly. The aim of this study is to assess     serum blood folate levels measured at baseline, midpoint, and endpoint of the study.     Hypothesis: Folic acid (5mg)given once weekly is as effective as folic acid (1mg)given daily     in raising blood folate levels.   "
181170|NCT00207558|"     The aim of this study is to examine whether the same total daily dosage of folic acid, when     taken as a single daily dose or as multiple divided doses throughout the day, results in     different blood folate and homocysteine levels at the conclusion of the study. Further, a     comparison of blood folate and homocysteine levels among women taking daily low-dosage     (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly     high-dosage (4000mcg) folic acid will be conducted.   "
181171|NCT00207571|"     To help public health professionals (DIS) in interviews of patients infected with STD for the     names of their sex partners, this project used a computer-based partner elicitation program     before the actual DIS interview. The main outcome was the mean number of partners named by     those who had the intervention versus those those who did not.   "
181172|NCT00207584|"     This study was designed to determine whether taking daily doxycycline during an outbreak of     Mycoplasma pneumoniae could prevent a person from getting infected and interrupt ongoing     disease transmission during an outbreak. Doxycycline is a treatment for Mycoplasma     pneumoniae, but it is not certain that the drug could prevent disease if used     prophylactically.   "
181173|NCT00207597|"     This study examines the progression of joint disease in children with hemophilia assigned to     either standard treatment or enhanced therapy.   "
181174|NCT00207610|"     Anemia is common among low-income women after they have given birth. Anemia, or low     hemoglobin in the blood cells, is usually caused by not having enough iron. Blood cells     usually carry oxygen to other parts of the body. Without enough hemoglobin, the ability of     blood cells to carry oxygen is decreased. Memory and work may be impaired. The purpose of     this study is to evaluate three methods of giving iron to prevent anemia among low-income     women after they have given birth.   "
181175|NCT00207623|"     While there are a variety of arthritis education materials available, the evidence-base on     most of them is slim, so it i impossible to know what benefits they may have for the people     who participate. The purpose of this project is to evaluate the effectiveness of the     mail-delivered self-management education program, Arthritis Basics for Change (ABCS) with an     emphasis on changes in knowledge, beliefs, behavior, self efficacy and health outcomes, and     to evaluate the appropriateness, usefulness, and readibility of the program. This project     will assist CDC's Arthritis Program in determining the usefulness of the ABCs program for     helping people with arthritis improve their quality of life.   "
181176|NCT00207636|"     The purpose of this study is to develop and evaluate a computer-based decision aid (DA) for     use by men considering PSA screening for prostate cancer. Major medical organizations     recommend that men discuss the risks and benefits of this test with their physician before     making the decision. This educational, interactive DA will help them prepare for that     discussion.   "
181177|NCT00207649|"     Interventions to Improve Shared Decision-Making: Prostate Cancer Screening is a prospective     study of educational interventions to improve the interaction of physicians and their     patients about prostate cancer screening. Educational material is provided in primary care     practices using either standard paper information or a novel web-based interactive curriculum     that explores the risks and benefits of screening measures for prostate cancer for older men.     The impact of the intervention on shared decision-making with both actual and standardized     patients will be assessed.   "
181178|NCT00207662|"     This is a study of infliximab (Remicade) in subjects with Crohn's disease   "
181179|NCT00207675|"     A study of the safety and efficacy of infliximab (Remicade) in pediatric patients with     moderate to severe Crohn's Disease   "
181180|NCT00207688|"     The purpose of this study is to evaluate long-term safety information of infliximab in     patients who have participated in infliximab clinical studies in ulcerative colitis.   "
181181|NCT00207701|"     A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with     Ankylosing Spondylitis   "
181182|NCT00207714|"     Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to     assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at     either 2- or 4- week intervals in subjects with active RA despite MTX therapy.   "
181183|NCT00207727|"     The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients     with Multiple Sclerosis   "
181184|NCT00207740|"     The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab)     in patients with severe persistent asthma.   "
181219|NCT00208195|"     The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in     the treatment of patients with bipolar disorder in the manic phase, who also have comorbid     substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young     Mania Rating Scale and the Substance Abuse Time Line Follow Back.   "
181185|NCT00207753|"     The aim of this study is to compare the efficacy and impact on growth of two drug treatments     against intestinal worms in schoolchildren from a rural area of Guatemala. According to the     World Bank, these intestinal worms are one of the top causes of childhood health problems in     many areas of the developing world (The World Bank, 1993). Infected children are more likely     to have inadequate nutrition due to the worm infections and are more likely to be shorter in     height and weigh less than children who are not infected. After collecting height and weight     information, we will split the children into two groups. One group will receive albendazole     and the other group will receive combined albendazole/ivermectin. Both groups will be     receiving albendazole, the current standard of care treatment. Ivermection is expected to     improve efficacy and nutritional benefit as well as add increased scope of treatment for the     worm Strongyloides, and ectoparasites such as scabies and head lice. Both treatment regimens     and the combination have been used millions of times in the developing world and are safe to     use. Co-administration of drugs would be a more efficient use of the opportunity to access     schoolchildren and provide deworming treatment.   "
181186|NCT00207766|"     A study of infliximab in patients with Fistulizing Crohn's Disease   "
181187|NCT00207779|"     We, the researchers at Centre National de Greffe de Moelle Osseuse, have shown in a     randomised study (in press), that a low dose of unfractionated heparin (100 IU/kg/daily) was     safe and effective to prevent catheter-related bloodstream infection in patients with     haemato-oncological disease.      The aim of this prospective randomised controlled trial is to compare the incidence of     catheter-related bloodstream infection in 2 groups of patients with haemato-oncological     disease:        -  Group A: heparin impregnated catheters        -  Group B: low-dose unfractionated heparin (100 IU/kg/daily)   "
181188|NCT00207792|"     The effect of haematopoietic growth factors on neutrophil recovery after allogeneic bone     marrow transplantation is well recognized. Recent laboratory studies demonstrated that these     cytokines may also modify T-cell and dendritic cell function, but whether the effect is     strong enough to alter the risk of graft-versus-host disease (GvHD) is unclear.      The aim of this randomised study is to determine the effect of granulocyte colony-stimulating     factor [G-CSF] (Neupogen; filgrastim) on the risk of acute GvHD after allogeneic bone marrow     transplantation.   "
181189|NCT00207805|"     Autologous peripheral blood stem cell (PBSC) transplantation is now considered standard     therapy in patients (< 65 ans) with multiple myeloma. The Intergroupe Francophone du Myelome     conducted a randomised trial of the treatment of multiple myeloma with high dose chemotherapy     followed by either one or two successive autologous stem cell transplantation. The     probabilities of event-free-survival and overall survival were doubled with a double     transplant. The benefits were greatest among patients who had not had a very good partial     response to the first transplant.      The aim of this multicenter randomised trial in previously untreated patients with multiple     myelome (stage II, III DS)is to assess the optimal timing of a second autologous stem-cell     transplant.After a first-line therapy with thalidomide-dexamethasone followed by a PBSC     collection, patients are randomly assigned to receive two autologous PBSC transplants (arm     A)or one autologous PBSC transplant followed by a consolidation therapy with     thalidomide-dexamethasone (arm B). Patients included in the arm B will receive a second     transplant in case of disease progression on consolidation therapy, or in case of relapse in     responders.   "
181190|NCT00207818|"     The aim of the study is to evaluate the effect of a biological dressing on the healing     process of venous ulcers. The dressing is a reconstructed skin substitute made with the     patients own cells.   "
181191|NCT00207831|"     RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing and     also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells.     5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil     is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation     therapy before surgery may shrink the tumor so it can be removed.      PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in     treating patients who are undergoing surgery for operable rectal cancer.   "
181192|NCT00207844|"     Septic shock is a frequent syndrome with a 45% mortality rate despite intensive care unit     (ICU) care, where free radicals may play a key role, and a >40% decrease in plasma selenium     concentration is observed. Selenium is a trace element with both indirect enzymatic     anti-oxidant, and direct oxidant properties. High dose of sodium selenite administration     could increase antioxidant cells capacities, and reduce inflammation by a direct paradoxical     pro-oxidative effect. We conduct a study to evaluate the effects of selenium treatment in     comparison to placebo, in septic shock patients. Efficacy will be evaluated by the weaning     time of catecholamines.   "
181193|NCT00207857|"     Nearly all patients with Duchenne's Muscular Dystrophy (DMD) have scoliosis. Posterior     instrumented spinal fusion, which is a surgery to correct scoliosis, has been shown to     improve quality of life and satisfaction of both parents and families. The progressive     muscular weakness leads to the development of scoliosis soon after the child has become     unable to walk. The muscular weakness and scoliosis also affect the pulmonary function of     these children. Pulmonary Function Tests (PFT) have been used to determine pulmonary     fitness prior to surgery as a way to determine how well or if the child will tolerate     surgery. Children with poor results on the PFT are determined to be too fragile to tolerate     such a large operation. The physicians conducting this study feel that the PFT may be     inaccurate and that this may not be the best single test to determine pulmonary fitness.     The physicians conducting the study think things like the time of day the study is done, how     tired you are when you complete the test, and how well you understand the test may affect the     results of the test.   "
181220|NCT00208208|"     Atypical antipsychotics have shown promise in the treatment of depression and anxiety, which     are prominent symptoms of PTSD. The profile of the atypical antipsychotic, ziprasidone     (Geodon), suggests possible anxiolytic and antidepressant properties. This research will     assess the potential effectiveness of Geodon in civilian men and women who suffer from severe     PTSD. Response to ziprasidone or placebo will be measured by Clinician Administered PTSD     Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).   "
181221|NCT00208221|"     The purpose of this study is to determine if a dose of ramipril combined with a normal dose     of telmisartan 80 mg will be more effective than ramipril 20 mg in reducing microalbuminuria     in hypertensive patients with diabetes.   "
181194|NCT00207870|"     Supracondylar fractures are the most common elbow fractures in children. In the current     orthopedic literature crossed pinning and lateral-only entry techniques are co-gold standards     of operative treatment. The crossed pinning technique has been shown to be biomechanically     superior especially under torsional loading but has a higher incidence of iatrogenic injury     to the ulnar nerve. All studies comparing these techniques to date have been either     biomechanical or retrospective in nature. A randomized, controlled, prospective study     comparing these two popular techniques has not been performed.      The purpose of this study is to prospectively evaluate the amount of displacement incurred     when treating type III supracondylar humerus fractures in children with crossed pinning     versus lateral-entry only technique. Overall complication rate, loss of reduction, iatrogenic     neurovascular injury, and pin tract infection rates between the two cohorts will be     evaluated. The study population will comprise all patients less than ten years of age     presenting to Scottish Rite Hospital during the study period with a type III supracondylar     fracture managed by the Children's Healthcare of Atlanta Orthopedic Group. All patients will     be randomized to one specific treatment arm based on surgeon preference established at the     onset of the study. The hypothesis to be tested is that no difference in amount of     displacement or overall complication rate is present between these two techniques.     Radiographic parameters measured pre-operatively, immediately post-operatively and four weeks     post-operatively will be quantitatively evaluated and compared. Chart reviews to determine     complications during the treatment period will be made. Pre-study power analysis and     post-study statistical analysis will be performed.   "
181195|NCT00207883|"     The purpose of this study is to see how fast and accurate two different techniques used by     physicians to insert catheters in children are. Catheters are tiny tubes which carry fluids,     blood and sometimes liquid food into a person's vein. The technique currently used relies on     the physical landmarks and using fingers to feel the anatomy in which to place the catheter     in the vein or artery. The investigators are changing to a technique where they will use     ultrasound at the patient's bedside to help physicians with placing the catheter into the     blood vessel. They are comparing the use of these two methods to determine which is faster     and requires fewer needle sticks.   "
181196|NCT00207896|"     Research studies in adults have shown that certain hormones may be decreased or may not work     normally which contributes to how sick a person becomes. The purpose of this project is to     study hormones in children. The investigators will look to see if a decrease of certain     hormone levels affects how sick a child may become. This study is intended to develop a     connection between hormone levels and severity of illness. It is hoped that the information     gathered will help develop further studies that may more clearly explain the role of hormones     in critically ill children and possibly the introduction of hormone replacement in critical     illness.   "
181197|NCT00207909|"     Acute kidney failure is common in children in the Pediatric Intensive Care Unit (PICU). You     are being asked to participate in this study because your child is being treated for kidney     failure with continuous veno-venous hemofiltration (CVVH). CVVH is a continuous, gentle form     of removing excess fluids and small wastes from the blood, similar to kidney dialysis     (artificial kidney). It is an accepted therapy for temporary support of kidney failure. In     some patients with acute kidney failure, beginning CVVH is followed by a temporary decrease     of urine output. The reason why this happens is currently unknown. The purpose of this study     is to determine why this happens.   "
181198|NCT00207922|"     The purpose of this study is to see the correlation of polarization and the expresison of     chemokine receptors of T help cells after allogeneic hematopoietic stem cell transplantation     and clinical course graft-versus-host disease.   "
181199|NCT00207935|"     This study is being done to see if children with learning problems can learn how to swallow     pills without chewing them. The reason this is important is that if a person has seizures,     medications must be taken every day. Most medications need to be taken 2 or 3 times per day.     Some medications have slow release and only are taaken once per day. Medications with slow     release usually come in capsule form and cannot be opened or chewed. This study investiates     whether children with developmental delay can be taught how to swalow pills.   "
181200|NCT00207948|"     This was a feasibility study aimed at elevating protease inhibitors (PI) dosage as a part of     active antiretroviral therapy (HAART). After the pharmacokinetics for the currently     prescribed PI were determined,patients with a vIQ<1 were eligible for a 50% dose increase for     an 8 week time frame after which their vIQ would be reassessed to determine if increasing     their PI dosage thereby increasing the bioavaiability would reduce their viral load.   "
181201|NCT00207961|"     Using patients receiving spinal anesthesia as a model to evaluate the treshold value of     cerebral oximeter to detect the symptoms of cerebral ischemia   "
181202|NCT00207974|"     Hyperuricemia is often associated with metabolic syndrome, which is a known precursor of     atherosclerosis. The Yaizu Suisankagaku Industry Company have developed industrial     production, named Marine Active. Human clinical trials showed reduction of creatine     phosphokinase activity and sero-uric acid. Randomize, double blind clinical trial is entrust     to our hospital. This study design is blood sampling from the health men who take 1 gm of     marine active to analyse the pharmacokinetics of anserine.   "
181203|NCT00207987|"     This is a study using cerebral oximetry to evaluate the safety of traditionally adopted     hypotensive anesthesia.   "
181204|NCT00208000|"     Hyperuricemia is a common metabolic disorder.The Yaizu Suisankagaku Industry Company have     developed industrial production named Marine Active, was able to offer anti-fatigue activity     by animal trial data. Human clinical trials showed reduced creatine phosphokinase activity     and a sero-uric acid reduction activity was also observed. So we are committed to design the     clinical randomized, double blind study about hyperuricemia management with Marine Active.     All these efforts are hoped to find a novel method to manage hyperuricemia.   "
181222|NCT00208234|"     The purpose of this study is to determine if Xolair can reduce the abnormal increase in     limitation to airflow in patients with asthma in a relatively short time period. Another     purpose is to determine if Xolair will decrease the amount of inflammation in the lungs of an     asthmatic patient in the same time period.   "
181223|NCT00208247|"     The purpose of this study was to examined if psychotherapy is an effecitive treatment for     hypochondriasis.   "
181224|NCT00208260|"     Randomized, open label, multicentre phase II trial followed by phase III comparing overall     survival after having selected the best experimental arm.   "
181205|NCT00208013|"     Cachectic patients often lose their appetite, lose weight, and are prone to weakness and even     death in advanced illness. Nutrition therapy is important and of concern to the investigators     in cancer patients. More than 80% of terminal cancer or advanced illness patients get     cachexia. Cachexia is a complex, multifactorial syndrome that results from a reduction in     food intake, a variety of metabolic abnormalities (including hypermetabolism) or more often a     combination of the two. Cachexia will progress with disease progression. Cachexia or weight     loss is often the major cause of death or poor quality of life.      The change of resting energy expenditure (REE) is different in various tumor types. Most     experts agree that the REE will increase in cancer cachexia syndrome. The more weight loss,     the more cachexia will occur.      Overnutrition is not beneficial in terminal patients according to the Chiu and Easson     studies. As the investigators know, few studies focus on REE in terminal patients. In this     study, samples are from a hospice palliative ward or from hospice home care patients in a     medical center in mid-Taiwan. About 100 patients will be recruited. The investigators will     analyze the relationship between REE and its related factors. After finishing the study, they     will provide more evidence for treating cachexia in terminal patients.   "
181206|NCT00208026|"     Netherton syndrome is a genetic condition that can result in abnormal skin functioning.     People with this condition often have red and scaling skin; sparse or short hair; and     problems with absorption of medicines or chemicals that are applied to the skin. If these     chemicals are absorbed at a high level, they may cause health problems. Elidel (pimecrolimus)     is a new medicine that is available as a cream. It has been shown to help improve the     appearance of the skin in patients with another skin condition known as atopic dermatitis,     and is approved by the United States (US) Food and Drug Administration for use in children     with mild to moderate atopic dermatitis. The purpose of this study is to determine if Elidel     is safe, to see whether the medication is absorbed through the skin, and to see if side     effects are associated with its use in children with Netherton syndrome.   "
181207|NCT00208039|"     A research study that will evaluate if giving surfactant medication to premature babies     weighing < 1250 gm at birth during the second and third weeks of life will help their lungs.     We are enrolling those premature babies who continue to require the breathing tube and the     mechanical ventilator at days 7-10 of life.   "
181208|NCT00208052|"     The purpose of the pilot study is to validate an assesment tool to be used in the assessment     of pain in the verbal, congitively intact patient. The ultimate goal is to be able to     validate this tool in the non-verbal/cognitively impaired patient.   "
181209|NCT00208065|"     The primary objective of this study is to evaluate histamine, CGRP and VIP levels in saliva     as biological markers for activation of trigeminal and parasympathetic nerve fibers in     various clinical presentations of primary headaches compared to allergic rhinosinusitis and     control populations.   "
181210|NCT00208078|"     There is no randomised controlled trials to determine the clinical effects of long term     Non-Invasive Ventilation in Cystic Fibrosis patients.   "
181211|NCT00208091|"     This study uses a computerized method of musical instrument digital interface (MIDI)     quantification of performance before and after treatment with botulinum toxin type B (Myobloc     ®, Solstice Neurosciences). Myobloc is a purified and diluted form of botulinum toxin used     medically to relax unwanted muscle spasms and movements. The aim of the study is to determine     the feasibility of quantifying change in performance following treatment.   "
181212|NCT00208104|"     The purpose of this project is to study ways to make it more likely that patients will take     their blood pressure medicine as recommended by their doctors.   "
181213|NCT00208117|"     The purpose of this study is to examine the relationship between depressive symptoms and     markers of inflammation, two predictors of heart disease.   "
181214|NCT00208130|"     The primary objective of this study is to investigate the safety and efficacy of topiramate     in the treatment of PTSD in women survivors of domestic violence and/or rape trauma as     measured by the Clinician-Administered PTSD Scale (CAPS) for DSM-IV.   "
181215|NCT00208143|"     It is hypothesized that the atypical antipsychotic, Seroquel, will cause significant     reduction in drug and alcohol cravings in patients with schizophrenia and comorbid cocaine     and/methamphetamine dependence compared to the atypical antipsychotic, risperidone     (Risperdal).      Patients treated with Seroquel will have less use of cocaine and/or methamphetamine as     measured by the Time Line Follow-back, over a 24-week follow-up period.   "
181216|NCT00208156|"     Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called     cortisol. Under normal conditions, cortisol and other hormones are created by the body in     response to physical and emotional stress, triggering a healthy stress response. People who     suffer from psychotic major depression may have unusually high levels of cortisol circulating     within them or abnormal patterns of cortisol levels, overloading the stress response     mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If     Corlux can keep the body's cortisol receptors from being overloaded, the stress response     system may return to normal function, which may result in improvement of symptoms. The     purpose of this study is to allow patients who have already participated in an earlier 8 week     study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment     with Corlux periodically if a psychotic episode should reappear during a period of one year.   "
181217|NCT00208169|"     It is hypothesized that the use of aripiprazole (Abilify) in patients with alcohol and/or     drug dependence with comorbid psychiatric conditions will lead to:        -  Reduction in the amount of alcohol and/or drugs used as measured by the Time Line Follow          Back (TLFB) and the Addiction Severity Index (ASI)        -  Reduction in cravings for alcohol and drugs as measured by the Penn Alcohol Craving          Scale        -  Reduction in symptoms of co-morbid psychiatric disorders compared to before starting          aripiprazole.   "
181218|NCT00208182|"     This medical study is an assessment of clinical response in women with Posttraumatic Stress     Disorder (PTSD) due to domestic violence or rape trauma when treated with risperidone.     Response to risperidone or placebo (inactive drug) is measured by Clinician Administered PTSD     Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8). Second, the effect of risperidone on     depressive and anxiety symptoms will be assessed using the Hamilton Rating Scale for Anxiety,     Hamilton Rating Scale for Depression and the Clinical Global Impression.   "
181226|NCT00208286|"     This post-market clinical follow-up study was designed to compile long-term knee replacement     outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform (RP) knee systems. The     first patient had surgery on November 8, 2001 and the final patient had surgery on July 29,     2005. There were 120 knees consented by a single site, which was the planned sample size in     the study protocol, with 117 receiving one of the study devices. The study was terminated as     the primary outcome was met and the investigator decided to conduct the study without sponsor     support after 2009.   "
181227|NCT00208299|"     Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to     thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The     investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist,     the receptor responsible for coronary vasodilation, and is being studied for potential use as     a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will     compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible     myocardial perfusion defects.   "
181228|NCT00208312|"     Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to     thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The     investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist,     the receptor responsible for coronary vasodilation, and is being studied for potential use as     a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will     compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible     myocardial perfusion defects.   "
181229|NCT00208325|"     The primary objective of this investigation is to evaluate the performance (in terms of     post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma     Rotating Platform total knee systems in clinical practice.   "
181230|NCT00208338|"     Primary Endpoints:      Comparative evaluation of any differences between the two groups in change from baseline to     the 3-month time point in terms of:        -  Functional recovery (patient-based) - using the Oxford Shoulder Score.        -  Functional recovery and early return of strength (pain, activities of daily living          [ADL], range of motion [ROM], and power) - evaluated using the Constant Shoulder          Assessment.        -  Functional recovery (pain and function - patient-based), evaluated using the American          Shoulder and Elbow Surgeons (ASES) Shoulder Assessment - patient self-report section.        -  Region-specific Quality of Life - using the Western Ontario Rotator Cuff (WORC) Index.        -  Range of motion - assessed by goniometer recorded as part of the Constant Score.        -  Pain (taken from Pain visual analog scale [VAS] of the ASES Shoulder Assessment); and        -  Record of escape pain medication usage (recorded in a daily patient diary).      Secondary Endpoints:      Comparative evaluation of any difference between the two groups in change from baseline to     the 6-week time point, in terms of:        -  Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain          medication usage (recorded in a daily patient diary).      Comparative evaluation of any differences between the two groups in change from baseline to     the 6-month time point, in terms of:        -  Functional recovery (patient-based) - using the Oxford Shoulder Score.        -  Functional recovery and early return of strength (pain, ADL, ROM, and power) - evaluated          using the Constant Shoulder Assessment.        -  Functional recovery (pain and function - patient-based), evaluated using the ASES          Shoulder Assessment - patient self-report section.        -  Region-specific Quality of Life - using the Western Ontario Rotator Cuff Index.        -  Range of motion - assessed by goniometer recorded as part of the Constant Score.        -  Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain          medication usage (recorded in a patient diary).      Comparative evaluation of any difference between the two groups in change from baseline to     the 6-week, 3, 6 and 12 month time points, in terms of health status - assessed by the EQ-5D     instrument.   "
181231|NCT00208351|"     The purpose of this study is to compare the performance of 4 designs of the DePuy Ultima LX     hip stem in the treatment of patients with hip joint disease requiring a total hip     replacement. Patients who enter the study will be randomly allocated to one of the 4 designs     of the DePuy Ultima LX hip stem and will be evaluated at regular intervals following hip     surgery using patient, clinical and x-ray assessments.   "
181232|NCT00208364|"     The purpose of this study is to monitor the performance and determine the metal ion release     of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients     with hip joint disease requiring a total hip replacement. Patients who enter the study will     be evaluated at regular intervals following hip surgery using patient, clinical and x-ray     assessments. A subset of patients will also have blood samples taken at regular intervals to     allow the metal ion levels to be determined.   "
181233|NCT00208377|"     The purpose of this study is to monitor the performance and determine the metal ion release     of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip     resurfacing surgery. Patients who enter the study will be evaluated at regular intervals     following hip surgery using patient, clinical and x-ray assessments. A subset of patients     will also have blood samples taken at regular intervals to allow the metal ion levels to be     determined and undergo scans to allow the bone mineral density of the bone surrounding the     implant to be monitored.      DePuy decided to close this Study in 4Q 2009. The Study was terminated with effect from     December 2010 to allow for the completion of the 5 year follow up assessments.      Please note that subsequent to this decision DePuy voluntarily recalled the ASR products on     24 August 2010. Additional information regarding this voluntary recall and the follow-up of     patients affected by the recall can be found at the following links     http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157 and     http://www.depuy.com/countries_list.   "
181234|NCT00208390|"     The purpose of this study is to monitor the performance of the Summit™ hip in the treatment     of patients with hip joint disease requiring a total hip replacement. Patients who enter the     study will be evaluated at regular intervals following hip surgery using patient, clinical     and x-ray assessments.   "
181235|NCT00208403|"     The purpose of this study is to monitor the stability of a total hip replacement within the     thigh bone when used in artificial hip joints implanted with two different bone cements,     Acryloc™ and Palacos® R, in the treatment of patients with hip joint disease requiring a     total hip replacement. Patients who enter the study will be randomly allocated to Acryloc™ or     Palacos® R and will be evaluated at regular intervals following hip surgery using patient,     clinical, x-ray assessments and special x-rays which allow the stability of the hip implant     to be determined   "
181236|NCT00208416|"     The purpose of this study is to compare the short-term outcomes of two surgical techniques,     minimally invasive and conventional, when used in the treatment of patients with hip joint     disease requiring a total hip replacement. Patients who enter the study will be randomly     allocated to undergo surgery using the minimally invasive or conventional surgical technique     and will be evaluated at regular intervals following hip surgery using patient, clinical and     x-ray assessments with a focus on short term rehabilitation.   "
181237|NCT00208429|"     The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a     polyethylene-on-metal bearing combination in the treatment of patients with hip joint disease     requiring a total hip replacement. Patients who enter the study will be evaluated at regular     intervals following hip surgery using patient, clinical and x-ray assessments.   "
181337|NCT00215995|"     This study is for patients with esophageal, esophagogastric, or gastric cancer that has     spread to other parts of the body. The purpose of this study is to test the safety and     effectiveness of a new experimental drug called ZD 1839 following initial therapy with two     other chemotherapy drugs, called Irinotecan (CPT-11) and Cisplatin.   "
181238|NCT00208442|"     The purpose of this study is to compare the performance and compare the wear characteristics     of two polyethylene cup liners, Marathon™ and Enduron™, in the treatment of patients with hip     joint disease requiring a total hip replacement. Patients who enter the study will be     randomly allocated to one of the polyethylene cup liners, Marathon™ or Enduron™ and will be     evaluated at regular intervals using clinical and x-ray assessments.   "
181239|NCT00208455|"     The purpose of this study is to monitor the performance of the DePuy PROXIMA™ hip in the     treatment of patients with hip joint disease requiring a total hip replacement. Patients who     enter the study will be evaluated at regular intervals following hip surgery using patient,     clinical and x-ray assessments. A subset of patients will undergo scans to allow the bone     mineral density of the bone surrounding the implant to be monitored   "
181240|NCT00208468|"     This post-market clinical follow-up study was designed to compare hip replacement outcomes of     the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex     did not end up being used. The first patient had surgery on February 18, 2000 and the final     patient had surgery on September 2, 2005. There were 317 subjects consented but only 301 had     hip replacement surgery (subjects received: 220 European hips, 33 Zweymuller, and 48     Spotorno). The study took place at three sites. Each site used their standard device as the     control. The Austrian site enrolled 69 European hips and 33 Zweymuller hips. 92 European hips     and 48 Spotorno hips were enrolled in Germany. Finally, the site in Italy enrolled 59     European hips. Although the study protocol intended collecting DEXA and RSA outcomes, the     data collected by the sites did not include these outcomes.   "
181241|NCT00208494|"     The purpose of this study is to compare the performance of artificial hips with metal heads     and metal sockets to artificial hips with ceramic heads articulating with metal socket     components. The success of the total hip arthroplasty (THA) will be based upon all of the     following clinical and radiographic criteria being met at the two-year evaluation: (1) the     patient's clinical results as measured using modified Harris Hip evaluation rating system,     and the absence of a complication that requires the surgical removal or replacement of a     component; and (2) radiographic findings at study endpoint (i.e., two years follow-up).     Clinical and radiographic success at two (2) years postoperative is required for the study     hip to be deemed successful.   "
181242|NCT00208507|"     The study is designed to evaluate artificial hips with a 28 mm ceramic head and a ceramic     liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head     and a polyethylene liner.   "
181243|NCT00208520|"     Most patients are prescribed valproate as their first antiepileptic drug. It is unknown which     is the best second-line drug when patients do not become seizure free on valproate. This has     led the Dutch Epilepsy Clinics Foundation (SEIN) to start the SLICE study. Adult patients     with partial and/or tonic-clonic seizures, insufficiently responding to valproate, are     recruited for this study. These patients are randomized to receive one of three other drugs.     Patients wil initially use this drug next to valproate. Neurologists of more than 20 general     hospitals en neurologists of SEIN are participating in this study.   "
181244|NCT00208533|"     This is a 6-week open pilot study of aripiprazole for the treatment of adolescents, aged 12     to 18 years, diagnosed with autism.      Children who qualify for the study will be treated with aripiprazole for 6 weeks.      Treatment is provided at no cost.   "
181245|NCT00208546|"     This is a study to assess the efficacy and safety of the addition of cetuximab to the     combined regimen of capecitabine, oxaliplatin and bevacizumab in patients with previously     untreated advanced colorectal carcinoma. It is an open, comparative study, comparing the     effects of capecitabine, oxaliplatin and bevacizumab to those of the same regimen plus     cetuximab.      Seven hundred fifty patients will be included. Treatment will continue until disease     progression or serious toxicity and follow up will continue until death. It is anticipated     that the addition of cetuximab will lead to an increase in progression free survival.   "
181246|NCT00208559|"     The purpose of this study is to see if the drug, ziprasidone, is effective in treating     problems in adolescent associated with autism.   "
181247|NCT00208572|"     The proposal will assess the effectiveness of SRI treatment of anxiety following TBI. We     hypothesize that participants will report significantly fewer and less severe anxiety     symptoms after a 12-week course of citalopram than after a 12-week course of placebo.   "
181248|NCT00208585|"     The purpose of this study is to investigate the efficacy of an SSRI, sertraline for the use     of post-concussive symptoms following a traumatic brain injury. the study also seeks to     investigate the relationship between irritability and aggression and anosmia in individuals     who have suffered a traumatic brian injury.   "
181249|NCT00208598|"     It has been proposed that a higher cut off for BMI (body mass index) is to be used in Maori     to define overweight and obesity. However, no one has assessed the prevalence of co-morbid     conditions associated with BMI. It is well known that Maori are at greater risk of diabetes     and cardiovascular disease compared to non-Maori and a delay in the identification of those     who are overweight and obese may be detrimental for Maori. We will assess BMI, other measures     of adiposity and prevalence of co-morbid conditions with a comparison with a similar matched     non-Maori population.   "
181250|NCT00208611|"     Based on Parkinson's disease (PD)/vitamin B12 deficiency symptom overlap and PD patients'     propensity to avoid protein (the dietary source of vitamin B12), this study proposes to     prospectively investigate the vitamin B12 status of PD patients over time. In addition, this     study will provide critical pilot data evaluating the efficacy of treating those patients     considered to have below-normal vitamin B12 levels in serum. Further, it will also explore     the concept that supplementing PD patients having low-normal vitamin B12 levels with     vitamin B12 improves either the non-motor PD symptoms or homocysteine levels in PD patients     receiving levodopa.      Study Hypotheses:        1. Serum cobalamin (B12) concentrations in patients with Parkinson's disease (PD) are          significantly lower than B12 concentrations in a) cohabiting spousal caregiver controls;          and b) population-based, age-matched controls.        2. Supplementation with B12 in levodopa-treated PD patients with low (<200 pg/ml) or          low-normal (200-300 pg/ml) serum B12 levels is associated with significant improvement          in their non-motor symptoms and reduces total plasma homocysteine concentration [Hcy], a          known biomarker for risk of dementia and cerebrovascular disease.   "
181251|NCT00208624|"     We would like to conduct a retrospective chart review examining the incidence of surgical     heart block in children treated in the Cardiac Service Line at Children's Healthcare of     Atlanta. We would like to look at the last 30 surgical heart block cases seen at Children's     Healthcare of Atlanta. We will collect the following information on each patient:      Patient Date of Birth Date of the surgical procedure      Weight of the patient at the time of surgery Concomitant Diagnoses Need for permanent     pacemaker Outcome of pacing (i.e. pacing successful)      We hope to look at each data element in order to determine potential risks factors for     surgical heart block. By identifying the risk factors, the investigator hopes to establish a     training program regarding surgical avoidance of certain areas of the heart (if possible) and     education regarding pacemaker follow-up.      Each patient will be given a unique study number. The patient's name, social security number,     medical record number or initials will not be used in our research database.   "
181252|NCT00208637|"     High protein diets are popular among Maori, especially on the East Coast of the North Island.     The purpose of this study was to compare the metabolic effects of a moderate carbohydrate,     high protein diet (MCHP) with a high carbohydrate-high fibre (HCHF) diet on insulin     sensitivity in Maori at increased risk of developing diabetes and cardiovascular disease.   "
181253|NCT00208650|"     There are many children born with Congenital Heart Disease. Many of these children have to     undergo surgical procedures to correct the problem. Some patients must eventually get a new     heart. Once they get a new heart, we have to have ways to determine how well the new heart is     doing inside of the body. Tissue Doppler Imaging is one way of doing so. Tissue Doppler     Imaging is like an ultrasounds. It takes pictures of the heart. In addition to Tissue Doppler     Imaging, there is a newer non-invasive procedure called Tissue Synchronization Imaging which     will allow us to see how well the new heart is working as well. In this study we would use     both techniques to determine how well the new heart is working.   "
181254|NCT00208663|"     The purpose of this study is to determine if a simple 'pick-list' menu applied to a handheld     computer's time-motion program can be used to record reliably what a hospital-based doctor     does while working a shift in the hospital. In this study reliability will be measured by     comparing the data collected by at least two different observers recording data from the same     hospitalist during the same period of time.   "
181255|NCT00208676|"     There are many children that have heart dysfunction because they are either born with     Congenital Heart Disease (CHD) or developed poor heart function because their hearts are ill.     The invention of medical technology helps in the treatment of these children. New heart     echocardiogram (echo) techniques including Tissue Doppler (TDI), Tissue Synchronization     Imaging (TSI) and 3 dimensional echocardiography (3D) are imaging technologies that we hope     will help in the diagnosis and treatment of these children.      Tissue Doppler Imaging is a noninvasive technique that measures the speed of heart muscle     movement. Tissue Synchronization Imaging measures how well the lower pumping chambers of the     heart are working together. A 3D echo is a 3 dimensional picture of a beating heart that     allows your doctor to see the heart from any angle. These techniques are noninvasive, meaning     on the outside of your body. The size and function of the ventricles (the lower part of the     heart) can change under different conditions. Using these techniques we will attempt to     better determine how well the ventricles function during illness and health.   "
181256|NCT00208689|"     Congenital heart disease in infants and children often challenges healthcare providers both     in regards to diagnosis and in the management of these conditions. The field becomes more     complicated as one examines the myriad of defects that present and the complex care that is     required. Over the last 20-25 years, the remarkable advances in the medical and surgical     management of the most complex lesions have decreased neonatal mortality, such that many more     survive the neonatal period. Therefore, new challenges regarding the continued care of this     patient cohort of high-risk infants and children exist. In order to continue the improvement     of treatment(s) offered to these patients, continuous review and analysis of the current     standard of care is needed.      In this study, the investigators will collect information related to the current surgical and     medical therapies offered to patients enrolled in the High Risk Congenital Heart Program at     Children's Healthcare of Atlanta. All of the procedure and visit information will be a part     of the child's standard of care. This information will be placed in a database. The     investigators hope to learn more about the short-term and long-term effects of current     therapies and procedures.   "
181257|NCT00208702|"     This study will evaluate the effectiveness of treatment with supplemental triiodothyronine     (T3, Cytomel) and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), in     improving symptoms of major depressive disorder (MDD).   "
181258|NCT00208715|"     The main purpose of this study is to determine if Provigil® (modafinil) at a dose of 200 mg     once daily is safe and effective for treating symptoms of sleepiness and fatigue associated     with Major Depressive Disorder when added to a SSRI.   "
181259|NCT00208728|"     During open-heart surgery, blood flow is supported by a heart-lung machine that both pumps     the blood and gives it oxygen. A problem associated with a heart-lung machine is the damage     to some of the blood caused by protein in the blood cell sticking to the sides of the     heart-lung machine tubing. This breakdown of the blood cell affects the platelets, which help     the blood to clot. Use of the un-treated circuit will be phased out within the next few     years, as newer technology is available. The use of coated tubing has been shown to decrease     problems with post-operative bleeding in the adult population. No studies have been done on     the pediatric population. We plan to perform a prospective, randomized study using the     un-treated circuits used now, the  Smart circuit tubing manufactured by Cobe Cardiovascular     Inc., Arvada, CO and the PMEA circuit manufactured by Terumo Corporation, Tokyo, Japan.     Randomization will be performed by the perfusionist (the person that runs the heart-lung     machine) in charge of the case. No one else will be aware of which circuit is being used.     There will be no changes in the operation of the heart-lung machine, anesthesia or the     surgery because of this study.      Blood testing that is standard of care and some additional tests will be performed on a small     amount of blood drawn from. the patient via arterial lines. Additional blood sticks will not     be required to obtain this sample.   "
181260|NCT00208741|"     The main purpose of this study is to determine how safe and effective Gabitril is for     outpatients with Social Anxiety Disorder (SAD).   "
181261|NCT00208754|"     In today's world of advanced surgery, children born with congenital heart disease (CHD) are     surviving into adulthood. However, the surgical procedures these children undergo do not cure     the underlying problem and this these children develop other heart problems later in life.     Heart failure is the one of the most common heart problems effecting these patients. This     heart failure can be seen in both lower pumping chambers of the heart, however, sometimes     only one side of the heart is affected. Since there are several congenital heart defects that     are now seen in the adult population, an understanding of what causes heart failure in this     patient population can help physicians develop better treatments for this condition. The goal     of this study is to review the medical records of 350 adult patients with congenital heart     disease that has developed heart failure. During this review, we plan to collect information     regarding the various treatments utilized in these patients and to determine if there are any     common elements regarding the development of heart failure in adult patients with CHD.   "
181262|NCT00208767|"     The EFFERVESCENT trial is designed to evaluate the effects of a specific ARB, called     valsartan, on atherosclerosis. The investigators want to know if treatment with valsartan     will increase the blood levels of markers responsible for repair of the vessel wall, reduce     oxidation and inflammation, improve the function of the blood vessels, and arrest or slow     down the progression of atherosclerosis over time.   "
181263|NCT00208780|"     Tetrahydrobiopterin (BH4) is a cofactor for the nitric oxide (NO) synthase enzymes, such that     its insufficiency results in uncoupling of the enzyme, leading to release of superoxide     rather than NO in disease states, including hypertension. We hypothesized that oral BH4 will     reduce arterial blood pressure (BP) and improve endothelial function in hypertensive     subjects. Oral BH4 was given to subjects with poorly controlled hypertension (BP >135/85 mm     Hg) and weekly measurements of BP and endothelial function made. In Study 1, 5 or 10 mg kg−1     day−1 of BH4 (n=8) was administered orally for 8 weeks, and in Study 2, 200 and 400 mg of BH4     (n=16) was given in divided doses for 4 weeks   "
181264|NCT00208793|"     The purpose of this study is to test whether calcium and/or vitamin D supplementation     favorably affects a set of biomarkers of risk for colon cancer in persons who are at higher     than average risk for colon cancer (ie, have already undergone the removal of adenomatous     polyps, which are known to be precursors to developing colon cancer).   "
181265|NCT00208806|"     Pacemakers can be attached to one or more than one of the heart chambers. After watching     pacemakers work over time, doctors have found that the pacemakers that stimulate only one     chamber of the heart sometimes lead to problems later. These problems may be changes in the     size and shape of the heart. The heart cannot work as well when some of these changes happen.     We need to learn more about these changes and how to prevent them. There has not been an easy     way to do this. A new treatment called Cardiac Resynchronization Therapy (CRT) is associated     with biventricular pacing where two chambers of the heart are stimulated simultaneously.     Tissue Doppler Imaging,Tissue Synchronization Imaging and 3 dimensional echocardiography are     new forms of technology that look at the heart while it works. They are similar to a moving     x-ray that can watch the heart muscles moving. The movement can be measured. Doctors will     check for changes that happen over time. This has not been studied in children before because     this kind of is new to this group of patients. This technology is noninvasive which means it     can be done from the outside of the body and is painless.      The hearts of children grow fast. It is important to be able to know if the pacemaker or     problems from dilated cardiomyopathy are causing any changes in the heart that might cause     problems. We expect to be able to use information we learn from this study to improve how we     use pacemakers in the future to avoid problems that can happen over time.   "
181266|NCT00208819|"     The purpose of this study is to determine whether an antipsychotic medication alone or an     antipsychotic medication in combination with divalproex is the most effective and safest way     to treat agitation in elderly patients with dementia.   "
181267|NCT00208832|"     Coronary heart disease (CHD) is the most common cause of death in the United States. A common     term for CHD is blocked arteries. People with CHD or blocked arteries often have high     blood pressure, high cholesterol, or diabetes. They are also more likely to suffer a heart     attack. Many heart attacks could be prevented by taking medicines that control blood     pressure, cholesterol, and diabetes. However, only 50%-60% of patients take their medicines     as directed. Patients who don't take their medicines regularly are considered noncompliant.      One of the risk factors for noncompliance is low health literacy. Health literacy is the     ability to obtain, understand, and act on basic health information. Patients with low health     literacy may not understand their illnesses as well, or how to take their medicines properly.      The purposes of this project are        1. to learn more about the relationship between low health literacy and medication          compliance, and        2. to test 2 different strategies designed to help patients take their medicines more          regularly.      Patients with CHD were recruited when they arrived for a regular doctor's appointment. We     measured their health literacy skills, asked questions about how they take their medications,     and checked their blood pressure and last cholesterol and diabetes measurements. We then     assigned patients to 1 of 4 intervention groups (intervention ongoing). The first group is     receiving usual care, which includes regular medication instructions printed on the bottle     and no reminders to refill medicines. The second group gets monthly postcards reminding them     to refill their prescriptions. The third group gets a new medication schedule that shows     them, with pictures and figures, how they are supposed to take their medicines each day. The     fourth group receives both the postcards and the new medication schedule. We are following     patients for 1 year to see which intervention has the greatest impact on their medication     compliance, blood pressure, cholesterol, and diabetes measurements. We will also examine     whether patients' health literacy affects the success of the interventions.   "
181268|NCT00208845|"     Identify untreated, asymptomatic hypertension in ER patients   "
181269|NCT00208858|"     The purpose of this study is to gather pilot data to determine feasibility of and guide the     development of a larger clinical trial investigating the effects of topiramate as an adjunct     to nicotine replacement therapy and behavioral counseling in smoking cessation treatment. It     is hypothesized that topiramate will decrease nicotine craving and result in improved     outcomes for smoking cessation.   "
181270|NCT00208871|"     The primary goal of this study is to compare, within a clinical screening setting, the     performance of stereoscopic digital mammography with standard (non-stereo) digital     mammography in the detection of abnormalities in the breast, including early breast cancer.   "
181284|NCT00209053|"     The purpose of this study is to determine completeness of revascularization, graft patency,     clinical outcomes, health-related quality of life and costs in 200 initial trial participants     at > 5 years post surgery who had heart bypass surgery with heart-lung bypass (on-pump) or     without heart-lung bypass (off-pump). The hypothesis is that the patency of coronary artery     bypass grafts of off-pump surgery are no less durable than grafts from conventional on-pump     surgery.   "
181483|NCT00217932|"     The purpose of this study is to determine the effectiveness of divalproex sodium (Depakote)     versus placebo in treating children with temper outbursts and severe mood disorders.   "
181271|NCT00208884|"     One of the risks associated with heart transplantation is failure of the graft. A graft is     where the new heart is attached to the original vessels in the body. Approximately 10% of     children suffer graft failure which, leads to heart failure and possible death. The problem     is that we do not know some of the causes of graft failure thus, it is difficult to diagnose     early and treat. Due to graft failure, lots of children are placed back on the transplant     list and receive another new heart.      In this study, we plan to perform a retrospective chart review looking to see if we can     correlate graft failure with a problem with the vessels called coronary allograft     vasculopathy or rejection. In order to do this, we will collect data from patient's charts     that have been diagnosed with graft failure and compare their clinical presentation/data to     pathology reports of the explanted hearts from these children. Explanted hearts are the old     transplanted hearts that are removed in order to put a new heart into the body. Explanted     hearts at our institution are always sent to pathology for analysis thus it will be quite     easy to perform this review.   "
181272|NCT00208897|"     The primary objective of this project is to determine whether treatment with the SSRI,     fluoxetine versus placebo reverses alterations in the central CRF system induced by early     life stress experiences (i.e. childhood sexual and/or physical abuse) in cases with and     without major depression. We also evaluate whether neuroendocrine changes after SSRI     treatment correlate with clinical improvement.   "
181273|NCT00208910|"     A novel procedure for generalized anxiety disorder where an odorant cue is paired with the     state of deep relaxation during training. It is hypothesized that by smelling the odor in an     anxiety-provoking situation, the patient will more easily invoke a state of relaxation,     providing greater relief from the distressing tension and worry that characterize GAD.   "
181274|NCT00208923|"     Patients who have cancer of the bone marrow (leukemia) or lymph gland (lymphomas) are being     asked to take part in this study. This study uses a new chemotherapy regimen and matched     volunteer stem cell transplant to treat patients with cancers of this kind.   "
181275|NCT00208936|"     This study is designed pre-operative for patients with resectable, local-regional carcinoma     of the esophagus.   "
181276|NCT00208949|"     This is a study involving patients who are undergoing allogeneic peripheral blood stem cell     transplantation. Both donors and recipients are being sought for this study.   "
181277|NCT00208962|"     This is a research study involving the treatment of leukemia or lymphoma (lymph gland cancer)     in adults who have leukemia or lymphoma that is unlikely to be cured with regular anticancer     drugs or radiation treatments.   "
181278|NCT00208975|"     Patients with a low-grade, or indolent (slow-growing) form of non-Hodgkin's lymphoma (NHL) in     which the usual survival is between 7-10 years are being asked to take part in this study.     Although normally-used combinations of chemotherapy will cause NHL to disappear in 30-40% of     patients (called complete response or complete remission), almost all will have their disease     return.      In this study, researchers tested a combination of anti-cancer agents, fludarabine, rituximab     and GM-CSF with mitoxantrone or cyclophosphamide to see if a better and more long-lasting     response can be achieved. All of the medications are approved by the Food and Drug     Administration (FDA) and are available on the market. The agents we will use are:        -  Mitoxantrone and fludarabine and cyclophosphamide and fludarabine are combinations of          chemotherapy drugs that have been successfully used to treat NHL/CLL (Chronic          lymphocytic leukemia) that has returned after treatment and are comparable options for          treatment.        -  Rituximab, a monoclonal antibody that kills cancer cells by binding the CD20 antigen          found on the surface of B-cells, commonly used along with chemotherapy drugs to improve          response rates in lymphoma treatment.        -  GM-CSF (granulocyte-macrophage colony stimulating factor, also called sargramostim, GM,          or Leukine), a growth factor which stimulates the development of new (stem) cells.          GM-CSF encourages stem cells to divide, specialize, and become active. It is not a          normal part of treatment for NHL.      Using GM-CSF in NHL treatment is the experimental part of this study. The main purpose of     this study is to see if giving GM-CSF along with a standard anti-cancer treatment will work     better to reduce cancer, and to look at side effects of the treatment.   "
181279|NCT00208988|"     Prostate cancer is the most common type of cancer among men. It is also the second leading     cause of cancer-related death among men. Two screening tests are available to try to detect     prostate cancer early – the digital rectal examination (DRE) and the prostate specific     antigen (PSA) blood test. Unfortunately, physicians aren’t sure whether or not these two     screening tests help save lives, and there’s a lot of controversy about how to use them.     Recently, a major government committee (the U.S. Preventive Services Task Force) recommended     that physicians discuss the risks and potential benefits of prostate cancer screening with     their patients, and allow patients to make their own decision.      Because of the controversies, many physicians currently don’t discuss prostate cancer with     their patients. The problem is that it takes time and effort to have these discussions, and     the information is complicated. A lot of patients have trouble understanding it, especially     if they have a limited educational background or trouble reading. When patients have     difficulty obtaining, understanding, and acting on basic health information, we say that they     have “low health literacy.” Other researchers have shown that patients with low health     literacy don’t know as much about cancer screening and are less likely to get screened for     various cancers. They also tend to be timid about discussing things with their doctor, and     often go along with what the doctor says, rather than taking an active role in the decision     making.      In 2003, under IRB approval, we conducted a study with 2 goals: 1) to encourage patients to     talk to their doctor about prostate cancer screening, and 2) to learn more about the impact     of low health literacy on these conversations. To promote conversation, we used two handouts,     given to patients in the waiting room before they saw the doctor. The first was a patient     education handout about prostate cancer screening, written in very simple terms with useful     illustrations. The second was a handout that simply encouraged patients to talk to their     doctor about prostate cancer. Patients got one of the two handouts, or a nutritional handout     that served as a control. After they saw their doctor, a research assistant briefly     interviewed the patient to find out whether or not prostate cancer screening was discussed.     We also measured the patients’ health literacy skills, and asked a few other questions about     their decision to get screened for prostate cancer.   "
181280|NCT00209001|"     The purpose of this study is to determine if acupuncture is effective in relieving hot     flashes in women treated with hormonal therapy for breast cancer.   "
181281|NCT00209014|"     Patients who have relapsed or refractory large B-cell lymphoma are being asked to take part     in this study. The purpose of this study is to find out what effects (good and bad) the drug     thalidomide has on patients and the lymphoma.   "
181282|NCT00209027|"     The objective of this study is to determine whether subjects with negative symptoms of     schizophrenia have abnormal functioning of brain circuits relevant to reward processing, and     to determine whether any such abnormalities are normalized by treatment with aripiprazole.   "
181283|NCT00209040|"     The current study will investigate the ability of people with and without fear symptoms after     trauma to inhibit fear in an experimental situation.   "
181285|NCT00209066|"     The purpose of this study is to evaluate alterations in sympathetic tone in patients with     major depression with and without ischemic heart disease and then to reevaluate these     patients after 8 treatments with electroconvulsive therapy(ECT). We expect to support the     hypothesis that HRV are pathophysiologically associated with the state of major depression.     We hypothesize the following:        1. Heart rate variability (HRV) will be decreased prior to treatment of depression in          comparison to post-treatment measures of HRV.        2. After 8 treatments with ECT, HRV will be increased under basal conditions.   "
181286|NCT00209079|"     The purpose of this trial is to test the combination of Gleevec® (also known as imatinib     mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer.     This study is being performed to see if the combination of Gleevec and Taxotere is an     effective treatment for incurable stomach cancer with minimal side effects.   "
181287|NCT00209092|"     The purpose of this study is to find out if the combination of docetaxel and capecitabine can     shrink the size of breast tumors and preserve the breast.   "
181288|NCT00209105|"     This study will characterize the mental health consequences of early-life trauma.   "
181289|NCT00209118|"     A.OVERVIEW      This is a 26 week study examining the ability of paroxetine (Paxil) to prevent the     development of depression and neurotoxicity in patients receiving either 3 million units of     subcutaneous IFN(interferon-alpha-2b) 3 times/week (plus ribavirin, 1000-1200 mg/d)) or PEG     (polyethylene glycol) interferon-alpha-2b (1.5 micrograms/kg one time a week) and ribavirin     (800 to 1,400 mg a day) for chronic hepatitis C (CHC). The IFN plasma half life (t1/2 of 24     to 34 hours) of PEG, a CHC treatment recently approved by the FDA, is significantly prolonged     allowing for once a week dosing. Studies indicate that the side effect profile of the two     forms of IFN-alpha treatment are very similar. CHC patients will be screened for study     eligibility, and a total of 100 CHC patients between the ages of 18 and 65 years old will be     enrolled across three sites (30 at Emory site and a combination of 30 from the University of     Pennsylvania, Rush-Presbyterian-Saint Lukes Medical Center in Chicago and Montefiore Medical     Center in New York.) Two weeks prior to treatment with subcutaneous IFN-alpha-2b, patients     who meet inclusion and exclusion criteria will be stratified on the basis of a history of     major depression and then randomly assigned to paroxetine or placebo in double blind fashion.   "
181290|NCT00209131|"     The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining     if the medication Flomax will result in improved stone passage rates following SWL.   "
181291|NCT00209144|"     The purpose of this study is to determine if intense control of high glucose levels in     patients treated with angioplasty for heart attack has anti-inflammatory and anti-thrombotic     effects.   "
181292|NCT00209170|"     African-Americans suffer from increased prevalence of both type 2 diabetes and diabetes     complications, reflecting a combination of psychobehavioral factors as well as metabolic     dysfunction. In this process, depression may contribute to both the genesis of type 2     diabetes (through impact on neurohormonal activation, inflammatory mediators, and insulin     resistance), and difficulties in management (through decreased adherence to diet plans,     medication, and scheduled appointments). The preliminary data from the Grady Diabetes Clinic     indicates that depression may be common in African-Americans with diabetes, that depression     is a factor in non-adherence, and that non-adherence leads to poor glycemic control - a     direct cause of diabetes complications. What is not known is: how treatment of depression     could lead to both neurohormonal and psychobiological improvement, with improved patient     adherence and glycemic control.   "
181293|NCT00209196|"     Adherence to medical regimens refers to what degree a patient chooses to follow the advice     given by his/her healthcare provider. Good adherence typically involves behaviors such as the     patient taking medication as directed and going to scheduled clinic appointments. As many     patients often do not follow the advice of doctors as closely as suggested, many researchers     have tried to find out the reasons behind patients being non-adherent. This research has     looked at medical conditions such as diabetes, cystic fibrosis, and asthma. More recently,     researchers have started to look at adherence with children who have undergone solid organ     transplantation. This is because about 50% of these children are to some degree non-adherent     with their medical regimen. This comes at a costly price as ongoing non-adherence in     pediatric transplant can lead to the child's body rejecting the new organ and even death.     This study has been designed to look at the reasons that pediatric patients may choose to be     non-adherent. This study will look at issues related to the patient (e.g., age, family     support), related to the disease and regimen (e.g., length of illness, how complicated the     regimen is), related to the medication (e.g., taste, side effects), related to their mind     (e.g., memory problems, confusion), and related to their emotions (e.g., being depressed,     anxious). The investigators will be looking at each regimen-related behavior, such as     attending clinic appointments and will be asking each family about any barriers that make it     difficult. The investigators hope that knowing these barriers will help them make     interventions that fit the specific issues that each patient faces. Ultimately, doctors,     transplant coordinators, and psychological professionals will be able to use this information     to intervene early with families who report barriers that impact adherence.   "
181294|NCT00209209|"     The aim of this study is to answer the following independent questions in the treatment of     mantle cell lymphomas:        -  Can rituximab-fludarabine, cyclophosphamide (R-FC) improve the reduction of lymphoma          mass compared to rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone          (R-CHOP) and so become a new standard for initial cytoreductive therapy?        -  Can maintenance with rituximab substitute the interferon maintenance and even improve          the progression free survival in patients after successful initial cytoreductive          therapy?   "
181295|NCT00209222|"     The aim of this study is to determine whether alternating courses of cyclophosphamide,     doxorubicin, vincristine, prednisone/dexamethasone, cytarabine, cisplatin (CHOP/DHAP) plus     rituximab followed by total body irradiation [TBI]/high dose cytarabine     [ARA-C]/melphalan-peripheral blood stem cell transplantation (TAM-PBSCT) can improve the time     to treatment failure compared to CHOP plus rituximab followed by standard PBSCT     (dexamethasone, carmustine, cytarabine, etoposide, and melphalan [Dexa-BEAM]/TBI/high dose     cyclophosphamide) in patients with untreated mantle cell lymphoma.   "
181325|NCT00215228|"     Low heart rate variability is a marker of increased risk of cardiac mortality, and is     observed in depressed coronary artery disease patients. Some antidepressants may themselves,     however, decrease heart rate variability. We will test the hypothesis that greater reduction     in heart rate variability will be associated with duloxetine (which has noradrenergic     activity) than escitalopram (a selective serotonin reuptake inhibitor). We will also test the     hypothesis that changes in heart rate variability are related to the magnitude of     norepinephrine transporter occupancy.   "
181566|NCT00212342|"     The purpose of this study is to determine whether combination oral contraceptive pill of     Norethindrone & Ethinyl estradiol is effective in the treatment of dysmenorrhea associated     with endometriosis.   "
181296|NCT00209235|"     We, the researchers, are following the natural history of Albright hereditary osteodystrophy.     We have found that growth hormone deficiency is very common in patients with     pseudohypoparathyroidism type 1a, which falls under the broader condition termed Albright     hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically are short     and obese. Some of these patients are not short during childhood, but due to a combination of     factors, they end up short as adults. We are evaluating the effect of growth hormone     treatment in those patients with pseudohypoparathyroidism type 1a who are found to be growth     hormone deficient or those who are growth hormone sufficient and were found to have a     positive clinical response to growth hormone in a prior clinical trial under R01 FD003409,     IND 67148 or those who meet the criteria of idiopathic short stature or SGA.      We are also evaluating neurocognitive and psychosocial functioning in participants with AHO     in order to determine the specific impairments that are most common in the condition and to     determine the best approach toward management.      Funding source -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01     FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864   "
181297|NCT00209261|"     To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with     Minirin® tablet treatment after 6 weeks.      To compare efficacy of the 2 formulations at the end of the 6-week treatment period using     diary card data.      To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a     PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2     formulations   "
181298|NCT00209274|"     EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study     of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients     to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a     prospective multi-center study of the MitraClip System for the treatment of mitral valve     regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A     continued access prospective, multi-center study (REALISM) of the MitraClip System in a     surgical population (non-high risk arm) and a high surgical risk population (high risk arm)     is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high     risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month,     12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually     for 5 years.   "
181299|NCT00209287|"     Male or female, 18 years of age or older. Ulcerative Colitis described according usual     criteria, diagnosed for at least 1 year. Oral maintenance treatment with 5-aminosalicylic     acid (5-ASA) only for at least 3 months with a dosage of 2 to 3 g/day. Clinical remission for     at least 3 months (Mayo Clinic score) and endoscopic remission (endoscopic score of Mayo     Clinic) at the inclusion. Signed informed consent form.   "
181300|NCT00209300|"     This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation     will be done centrally. The patients will be treated for 1 year, with clinical and laboratory     assessments at 0, 4, 8 and 12 months.      Endoscopic examination is at enrollment and on completion of the study (at relapse or after     12 months).      Number of Subjects (Planned and Analysed):        -  360 patients for demonstration of non-inferiority between once daily and twice daily;        -  326 to be analysed in per-protocol (PP) analyses; and        -  360 in intention-to-treat (ITT) analyses.   "
181301|NCT00209313|"     The study proposed that both clinical and subclinical HSV reactivation is associated with     increased HIV shedding from mucosal surfaces, which may increase the infectiousness of     HIV-1/HSV-2 coinfected persons. To test this hypothesis, we will control HSV reactivation     with acyclovir, a safe medication that is proven to reduce HSV shedding, and measure HIV     levels in blood, genital, and pharyngeal secretions. The study hypothesizes that acyclovir     will reduce HIV shedding from mucosal surfaces of HIV-1/HSV-2 coinfected individuals.   "
181302|NCT00214929|"     The best management in selected patients of pulmonary Embolism (PE) should be at home. The     efficacy and safety treatment´s at home versus at hospital should be similar and quality of     life should be better. Our purpose is to demostrate that Low weight molecular heparin (LWMH)     at home for PE is at least as effective and safe at home as at hospital   "
181303|NCT00214942|"     A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of     ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain in Opioid-Tolerant Patients     with Chronic Low Back Pain   "
181304|NCT00214955|"     A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of     ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant     Patients with Chronic Neuropathic Pain   "
181305|NCT00214968|"     The primary objective of the study is to evaluate the safety and tolerability of treatment     with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with     narcolepsy or obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to     6 months.   "
181306|NCT00214981|"     Primary objective of this study is to evaluate the safety of treatment with modafinil     film-coated tablet.   "
181307|NCT00214994|"     A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL     Treatment in Adults with Generalized Anxiety Disorder.   "
181308|NCT00215007|"     The purpose of this study is to evaluate the efficacy of levofloxacin to prevent bacterial     infections in the postneutropenic period in patients who have undergone allogeneic stem cell     transplantation (SCT).   "
181322|NCT00215189|"     This pilot study evaluates an individualized health promotion program for people with mental     illness receiving services at a mental health center in Keene, NH. The study will test the     following hypotheses:      Hypothesis 1: Compared to baseline (pre-study) levels, participants in the In SHAPE program     will demonstrate increased physical activity as indicated by self-report and observed     measures.      Hypothesis 2: Compared to baseline (pre-study) levels, participants in the In SHAPE program     will demonstrate improved fitness and health status as indicated by greater capacity on the     6-minute walk test, one mile walk test, weight and body composition, and flexibility indexes.      The following secondary (exploratory) hypotheses will be considered:      Compared to baseline (pre-study) levels, participants in the In SHAPE program will     demonstrate improved subjective health status, quality of life, mood, and self-efficacy. In     addition, participants will demonstrate improved cardiovascular fitness as indicated by lower     pulse rate and blood pressure.   "
181309|NCT00215020|"     Isoprostanes are compounds that are produced as a result of oxidative damage to cell     membranes. Elevated tissue, serum, and urinary isoprostane levels have been described in a     number of inflammatory diseases. The goal of this study is to determine utility of measuring     urinary isoprostane levels in pediatric patients with inflammatory and non-inflammatory     gastrointestinal disease. Urine samples will be collected from pediatric patients undergoing     procedures in the Children's Hospital endoscopy unit. Clinical disease activity will be     assessed using a standardized clinical disease activityiIndex. Gross endoscopic and     histologic findings will be graded. Previously obtained laboratory studies will also be     recorded. Urinary Isoprostane levels will be determined using a commercially available assay.     Isoprostane levels will be compared across conditions (IBD vs. non-inflammatory, Crohn's     disease vs. ulcerative colitis) and tested for statistical significance. Similarly, disease     severity and urinary isoprostane levels will be assessed. The sensitivity, specificity, and     positive and negative predictive values of elevated urinary isoprostane levels at     discriminating pediatric patients with inflammatory and non-inflammatory gastrointestinal     disease will be calculated.   "
181310|NCT00215033|"     The purpose of this study is to determine the significance of an elevated quantitative EBV     PCR and to determine the relationship between a EBV PCR value and the risk of developing     PTLD.   "
181311|NCT00215046|"     To evaluate the efficacy of the chemotherapeutic agents vinblastine and methotrexate in the     treatment of two groups of children with multivessel pulmonary vein stenosis. Group 1 will     contain children with multivessel pulmonary vein stenosis who do not have structural heart     disease, and Group 2 will consist of children with multivessel pulmonary vein stenosis and     concomitant structural heart disease.      The primary outcome variable for efficacy is patient status one year after the start of     treatment, where status is classified as either failure or success. Failure is defined as     death or evidence of progressive obstruction at any time over the course of treatment as     defined in the protocol. Success constitutes complete or partial response to treatment or     stability of disease. Secondary outcome variables for efficacy are survival, time from     diagnosis of pulmonary vein stenosis until failure, and change in patient classification on a     scale measuring the severity of the obstructive disease.      1.2 To assess the safety of vinblastine and methotrexate in the treatment of multivessel     pulmonary vein stenosis.      The primary outcome variable for safety is any occurrence of toxicity related to the     administration of the chemotherapeutic agents over the treatment period.   "
181312|NCT00215059|"     Prospective, single center, descriptive study in 14 infants/children with multivessel     pulmonary vein stenosis stratified for patients with or without underlying cardiac disease.      Group 1: Patients without additional structural heart disease and multivessel pulmonary vein     stenosis.      Group 2: Patients with additional structural heart disease and multivessel pulmonary vein     stenosis.   "
181313|NCT00215072|"     The purpose of this study is to elucidate the patterns of death following congenital heart     surgery.   "
181314|NCT00215085|"     The purpose of this study is to define the natural history of untreated cardiac tumors, study     the pathology of primary cardiac tumors, review the surgical treatment and results of primary     cardiac tumors and to determine the prognosis for these tumors.   "
181315|NCT00215098|"     The purpose of this study is to determine at risk populations for certain congenital heart     defects or certain operative procedures and to define the associated morbidity secondary to     chylothorax - prolonged chest tube drainage, prolonged hospital stay, need for central access     and hyperalimentation, subsequent infection.   "
181316|NCT00215111|"     The purpose of this study is to test the hypothesis that a low-carbohydrate diet and a     low-glycemic load diet will improve body mass index and result in more body fat loss than a     control diet among overweight children ages 7 to 12. In addition this study is also designed     to test the safety of diets with modified carbohydrate content as compared to a conventional     weight management diet among younger overweight children.   "
181317|NCT00215124|"     The objective is to obtain initial information regarding the safety and efficacy of the use     of Filgrastim in the setting of acute myocardial infarction.      The secondary objectives are to obtain information regarding the mobilization of relevant     stem cell progenitor cells by Filgrastim in this setting and to obtain further clinical     information that may be helpful in the assessment of safety and efficacy of this drug as     utilized.      It is a one center, randomized, placebo controlled, dose escalation, blinded study. It will     be 2:1 randomization with 9 patients total.      Filgrastim 10 mcg/kg/day will be administered SQ for 5 days vs. placebo.      Primary endpoint is death /or myocardial rupture or change in left ventricular ejection     fraction from baseline to 30 days.      9 pts. have already completed the first phase of the trial using Filgrastim 5 mcg/kg/day.   "
181318|NCT00215137|"     This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating     obsessive-compulsive disorder (OCD) symptoms.   "
181319|NCT00215150|"     The purpose of this study is to examine the effectiveness and tolerability of augmentation     treatment of ziprasidone to achieve remission among patients with social anxiety disorder     (SAD) who did not remit on sertraline treatment alone   "
181320|NCT00215163|"     Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD.     However, although these interventions can be helpful, many patients remain symptomatic     despite initial treatment. In this study, we will examine the relative efficacy of the     addition of paroxetine-CR compared to placebo for patients remaining symptomatic despite a     brief and intensive course of cognitive-behavioral therapy (CBT).   "
181321|NCT00215176|"     The purposes of the study are to: 1) evaluate the short-term efficacy and safety of modafinil     in atypical depression; and 2) to evaluate the efficacy of modafinil in preventing relapse of     atypical depression. The hypothesis is that modafinil is safe and effective in the treatment     of atypical depression.   "
181323|NCT00215202|"     The use of Iressa will result in a greater than 20% response rate in patients with     nonresectable adrenocortical cancer who have previously been treated with one other form of     systemic therapy (either Mitotane or chemotherapy).   "
181324|NCT00215215|"     To compare outcomes over 12 months of treatment with antiepileptic drugs (AEDs) alone or     vagus nerve stimulation (VNS) therapy plus AEDs in patients who have partial seizures     refractory to at least two, but not more than five, AEDs.   "
181326|NCT00215241|"     The purpose of this study is to (1) compare the response of civilians with Posttraumatic     Stress Disorder(PTSD) currently receiving sertraline without an optimal response to     risperidone augmentation vs. placebo, and (2) to evaluate the tolerability of risperidone     augmentation, and (3) to identifiy predictors of response to risperidone augmentation. the     hypothesis is that risperidone augmentation of sertraline treatment of PTSD is safe and     effective.   "
181327|NCT00215254|"     The purpose of the study is to examine the effectiveness and tolerability of quetiapine for     the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be     effective and well-tolerated for patients with social anxiety disorder.   "
181328|NCT00215878|"     The aim of this study is to asses the effects of the NMDA receptor full agonist D-serine     while used as adjuvant treatment for individuals suffering from chronic posttraumatic stress     disorder (PTSD). Dysfunction of neurotransmission mediated at NMDA receptor plays a cardinal     role in the pathophysiology of PTSD and PTSD patients typically suffer from cognitive     dysfunctions and avoidance& depressive symptomatology that may be mediated by NMDA receptor     function deficits.      Thus, enhancement of NMDA activity by using D-serine may be beneficial in the treatment of     PTSD. The study design involves two 6 week periods during which the participants will be     randomly assigned to receive treatment with D-serine (~2g /dy)and placebo. This design allows     each participant the opportunity to respond to the experimental treatment.   "
181329|NCT00215891|"     Objectives:      Primary To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among     patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level     24 weeks after discontinuing therapy).      Secondary        -  To evaluate the safety and tolerability PEG Intron in combination with ribavirin for          treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human          Immunodeficiency Virus (HIV).        -  To determine the early virologic response of patients receiving PEGIntron plus ribavirin          at Treatment Week 24      Study Design:      All qualifying patients will enter the treatment phase and be dosed as follows:      Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus      Ribavirin:        -  800 mg (400 mg bid) if body weight < 65 kg        -  1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg        -  1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg        -  1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg      At Treatment Week 24, all participants with detectable HCV-RNA will be discontinued from     treatment and followed for a Post Treatment period of 24 weeks. Participants with     undetectable HCV-RNA values at Treatment Week 24 will be randomized to either:        -  Group A: an additional 24 weeks of previously assigned Peginterferon a-2b + Ribavirin          therapy, for a total of 48 weeks of treatment.        -  Group B: an additional 48 weeks of previously assigned Peginterferon a-2b + Ribavirin          therapy, for a total of 72 weeks of treatment.      Study Population:      300 HIV infected adults with chronic hepatitis C infection who have not been treated     previously with interferon therapy.      Dosage and Administration:      Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus      Ribavirin:        -  800 mg (400 mg bid) if body weight < 65 kg        -  1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg        -  1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg        -  1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg      Efficacy Evaluations:      Laboratory analysis, liver biopsies, quality of life assessments, and changes in     Peginterferona-2b and Ribavirin dosages will be obtained.      Safety Evaluations:        -  Assessment of laboratory evaluations        -  vital signs        -  incidence and severity of adverse experiences        -  dose adjustments        -  premature withdrawal for safety reasons        -  progression of disease as measured by HCV viral load        -  AIDS defining events   "
181330|NCT00215904|"     The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine     (~2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced     dyskinesias.      D-serine will be used as add-on therapy to on-going medications received by Parkinson's     Disease patients. The rational for this study stems from observations made in pervious     clinical trials with schizophrenia patients, in which it was demonstrated that D-serine     adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by     antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted     effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's     Disease.      The study will have a crossover design in accordance to which each patient will receive, in     random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have     the opportunity to receive the experimental treatment.   "
181331|NCT00215917|"     N-methyl-D-aspartate receptor (NMDAR) agonist, added to classical or atypical antipsychotic     medication, has reduced negative, depressive, and cognitive symptomatology. We will be     investigating the effect of D-serine, (DSR), a selective and potent NMDAR agonist, as     monotherapy for treatment resistant schizophrenics.      40 subjects on stable doses of risperidone will be randomized under double-blind conditions     into a treatment group, which will receive D-serine 2100 mg, or a control group, which will     continue to receive risperidone. Treatment will continue for 14 weeks.      Symptoms and side effects will be rated biweekly with the CGI, PANSS, BPRS, SAS, AIMS, and     UKU. Before and after the trial subjects will undergo neuropsychological assessments.     Baseline and post-trial levels of amino acids relevant to glutamatergic neurotransmission     (glutamate, glutamine, aspartate, glycine, serine, alanine) will be assessed.      The primary outcome measures of the study will be the PANSS total scores and the positive and     negative symptom cluster scores.   "
181332|NCT00215930|"     The standard treatment for non-small cell lung cancer, stage IV or IIIB malignant pleural     effusion is chemotherapy. The decision to use a regimen is currently determined by toxicity     or by physician's preference. In this protocol, the treatment regimen will be assigned based     on the patients' tumor molecular profile. A tumor molecular profile analysis will allow the     physician to define a specific molecular portrait that shows the genetic basis of the tumor.     This analysis results in a detailed report that will determine which chemotherapy will be     assigned to the patient.   "
181333|NCT00215943|"     Investigators planned to accrue 176 participants, to compare the response rate, overall     response rate and survival of patients with multiple myeloma (MM) when randomized to two     regimens (thalidomide+Dexamethasone versus Vincristine+Adriamycin+Dexamethasone).     Investigators also planned to test if treatment with zoledronate immediately prior to     chemotherapy results in an enhanced response to treatment (i.e. increase in complete response     rates).   "
181334|NCT00215956|"     This is an open-label, single center, phase I study designed to determine the MTD or oral     topotecan as a radiosensitizing agent in the treatment of rectal cancer patients. Sequential     cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of     concurrent radiation (45GY) over five weeks.   "
181335|NCT00215969|"     Pre-eclampsia is one of the most common causes of maternal and fetal morbidity and mortality.     The aim of this study is to identify pregnant women at risk for pre-eclampsia or other     cardiovascular complications at a very early state of the disease, and thereby improve the     current method of screening.   "
181336|NCT00215982|"     The purpose of this study is to find out how effective the new combination of the drugs     Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon     and rectal cancer. All three of these drugs are approved by the Food and Drug Administration     (FDA) for the treatment of colon or rectal cancer. This however is the first time that these     three drugs have been combined in this schedule for the treatment of colon/rectal cancer.   "
181339|NCT00216021|"     In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin     with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of     patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor     selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher     levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal     tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to     surrounding normal tissue. This trial will investigate the activity of this novel     capecitabine/oxaliplatin (CAPOX) combination in patients with advanced disease. In addition,     an exploratory analysis will correlate response with thymidine synthase and thymidine     phosphorylase expression in primary tumor samples.   "
181340|NCT00216034|"     A randomized controlled study is conducted on patients with resected gastric cancer assigned     to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1, with the objective     to examine or validate the outcome, QOL and prognostic factors (host and tumor factors), and     explore the factors enhancing the antitumor effect of TS-1.   "
181341|NCT00216047|"     HER2 gene amplification increases VEGF production in breast cancers; combined inhibition of     HER2 and VEGF enhances response in xenograft models. The upregulation of VEGF in     HER2-overexpressing breast cancers may contribute to the aggressive phenotype observed in     HER2-positive breast cancer. New therapeutics targeting VEGF and/or its receptors may enhance     the efficacy of trastuzumab monotherapy.      This trial will investigate the safety and efficacy of combined HER2 and VEGF inhibition.   "
181342|NCT00216060|"     Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent     than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind     trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these     studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up     to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials,     risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density     (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more     potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to     bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer     patients has been well established; therefore, it is advantageous to assess the efficacy of     oral bisphosphonate therapy.   "
181343|NCT00216073|"     In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin     with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of     patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor     selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher     levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal     tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to     surrounding normal tissue. Trastuzumab is synergistic in vitro with multiple chemotherapeutic     agents including the platinum compounds. Studies have shown the efficacy of trastuzumab     combined with chemotherapy in patients with HER2 overexpressing metastatic breast cancer.     This trial will investigate the activity of capecitabine and oxaliplatin administered with     trastuzumab (CAPOX-T) in patients with HER2 overexpressing in patients with advanced disease.   "
181344|NCT00216086|"     Preoperative induction chemotherapy has been successfully used in a variety of malignancies     and provides several advantages over postoperative therapy. Combination of     5-FU/Leucovorin/CPT-11 has demonstrated significantly better response rate than     5-FU/Leucovorin alone. Replacing 5-FU with oral capecitabine in combination with CPT-11 has     emerged as a potentially more effective, safe and convenient treatment option for metastatic     colorectal cancer. Capecitabine is also well tolerated in concurrent treatment with     radiation. Recent data has shown that preoperative radiation appears to be significantly more     effective in increasing resectability rates.      This trial will investigate the activity of capecitabine and CPT-11 combination in the     preoperative setting followed by chemoradiation with capecitabine in locally advanced rectal     cancer to improve response and decrease local recurrence. We will also study whether TS, TP,     DPD and carboxyesterase expressions correlate with the objective response rate with this     chemotherapy and chemoradiation regimen.   "
181345|NCT00216099|"     Docetaxel-based therapy has been shown to prolong survival as first-line therapy for patients     with hormone refractory prostate cancer (HRPC), and has become the standard of care. The     beneficial effects of any therapy in HRPC may be diverse and include reduction in tumor bulk     (when measurable), reduction in prostate-specific antigen PSA, reduction in symptoms     (particularly pain), or stabilization of disease. Clear reductions in tumor bulk or PSA may     provide objective evidence of a treatment effect, and stabilization of disease may be just as     clinically meaningful in patients who are actively progressing prior to starting therapy.     Pemetrexed has shown a broad array of activity in many diseases that until now were thought     to be non-responsive to chemotherapy in the second-line setting.      This trial is designed to further assess the efficacy, safety, tolerability, and     pharmacogenetics of pemetrexed as a single agent in subjects with HRPC whose disease has     progressed following one prior taxane-based chemotherapy regimen for HRPC.   "
181346|NCT00216112|"     Imatinib mesylate is an inhibitor of the receptor tyrosine kinases for platelet-derived     growth factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated     cellular events. Docetaxel promotes cell growth arrest by inhibiting the deassembly of     tubulin and by promoting at the same time microtubule assembly. Docetaxel has single agent     activity in ovarian cancer with response rates of 30-40% in the platinum refractory setting.     The combination of imatinib mesylate and docetaxel has potential synergistic effects, based     on previous reports showing synergy in-vitro and in-vivo between PDGFR inhibitors or PI3K     inhibitors and taxane chemotherapy.      This trial will investigate the efficacy the combination of imatinib mesylate and docetaxel     in treating patients with advanced, platinum-refractory ovarian cancer and primary peritoneal     carcinomatosis.   "
181399|NCT00216814|"     To determine if there is an association between basic fibroblast growth factor,vascular     endothelial growth factor, and interleukin levels and a patients response to BCG treatment (     as standard treatment)in the urine of patients with superficial TCC. To determine if the     levels of these angiogenic factors can predict response to BCG, disease recurrence,     progression risk factors.   "
181347|NCT00216125|"     In a previous phase II study, patients with pathological stage IIIb (without pleural     effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic     radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was     selected based upon a survival benefit in patients with recurrent NSCLC.      This trial will evaluate the role of consolidation therapy with docetaxel in patients with     unresectable stage III disease. The purpose of the trial is to evaluate survival and     toxicities of the regimens employed.   "
181348|NCT00216138|"     Recent progress in treatment of recurrent/metastatic SCCHN has been made with the     introduction of the taxanes. Docetaxel as a single agent has a response rate of 22-42% and     17% in patients with recurrent disease. Capecitabine is an oral fluoropyrimidine prodrug that     is converted into 5-FU. Previous studies have shown that the capecitabine/docetaxel     combination has a synergistic inhibition of tumor growth, resulting in significantly superior     efficacy in time to disease progression (TTP), overall survival, median survival and     objective tumor response rate compared to docetaxel alone.      This trial will investigate the efficacy the combination of docetaxel and capecitabine in     treating patients with recurrent/metastatic SCCHN.   "
181349|NCT00216151|"     Evidence for the beneficial effects of bisphosphonates on bone resorption in multiple myeloma     has been reported extensively, showing reductions in skeletal events and improvement of     several biochemical variables in bone resorption. Zoledronic acid (Zometa®, CGP42446) is the     most potent clinically available bisphosphonates, with the largest therapeutic ratio between     the desired inhibition of calcium resorption and the unwanted inhibition of mineralization in     vitro of all the bisphosphonates.      This trial will investigate the efficacy of zoledronic acid in preventing skeletal events in     patients with asymptomatic/early stage Multiple Myeloma   "
181350|NCT00216164|"     Rituximab has been demonstrated to sensitize drug-resistant NHL cells to the cytotoxic     actions of several chemotherapy agents by enhancing sensitivity of tumor cells to     chemotherapy-induced apoptosis. Gemcitabine, a nucleoside analog that is used in several     other malignancies, has shown very promising activity in patients with refractory Hodgkin's     disease and low-grade NHL. The combination of rituximab and gemcitabine may have synergistic     cytotoxic action in patients with relapsed or refractory DLBCL and possibly lead to improved     response rates and demonstrable clinical benefit.      This trial will investigate the efficacy the combination of rituximab and gemcitabine in     treating patients with relapsed or refractory DLBCL.   "
181351|NCT00216177|"     The purpose of this study is to establish whether RA patients with moderate to severe disease     activity with unsustainable response to infliximab 3 mg/kg every 8 weeks have better efficacy     with adalimumab 40 mg s.c. eow compared to infliximab 3 mg/kg i.v. every 6 weeks.   "
181352|NCT00216190|"     The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU     subjects who are initially intubated, mechanically ventilated and require sedation for beyond     24 hours.   "
181353|NCT00216203|"     Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping     toxicity profiles. While 2-drug combination therapy has proven superior to single agent     therapy in the first-line setting of NSCLC, no such phase III trials have been reported in     the second-line setting. Therefore, the purpose of this study is to determine the feasibility     of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating     the activity of the combination in an expanded phase II setting. If the combination appears     to have promising activity, further evaluation of this regimen may be warranted comparing it     to single agent pemetrexed or cetuximab alone.   "
181354|NCT00216216|"     Patients with relapsed or chemotherapy-refractory SCLC have a dismal prognosis.     Unfortunately, available treatments result in few durable responses. Pemetrexed is a     well-tolerated agent, which is active in NSCLC. Since chemotherapy agents, which are active     in NSCLC, are usually also active in SCLC, this trial will examine the efficacy and activity     of pemetrexed in this palliative setting   "
181355|NCT00216229|"     To compare the efficiency of protection against hepatitis-B virus by administration of the     combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the     schedule 0-1-6 months.        1. To compare the seroconversion (>= 1 IU/l) and seroprotection (>= 10 IU/l) rate at month          6,7,12 and 13.        2. To compare the distribution of anti-HBs at these different moments.   "
181356|NCT00216242|"     The goal of this study is to determine whether Fluviral, an inactivated, injectable trivalent     influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe     enough to limit normal daily activities and that are shown by virus culture to be caused by     influenza viruses. The study will also examine the safety of the vaccine and collect     measurements of the immune system responses produced by the vaccine.   "
181357|NCT00216255|"     The objective of the study is to determine the effects of pagoclone on the symptoms of     Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent     developmental stuttering in patients 18 to 65 years of age.   "
181392|NCT00216723|"     This is a multicenter,open-label,prospective study of Aripiprazole use in patients with     schizophrenia and bipolar disorder.   "
181393|NCT00216736|"     The aim of this project is to determine if a single dose of oral dexamethasone at the time of     discharge from the emergency department (ED) [after successful treatment] prevents rebound     headache.      Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who     suffer rebound headache after treatment for migraine in the ED.   "
181394|NCT00216749|"     This is a multicenter, open-label, prospective study of cilostazol use for prevention of     recurrence in patients with cerebral infarction.   "
181358|NCT00216268|"     Japanese encephalitis is the single largest cause of viral encephalitis in the world today.     It occurs in yearly post monsoon outbreaks in Uttar Pradesh and other parts of India and     south east Asia. There is presently no antiviral drug of proven benefit for this illness and     treatment is mostly supportive. The drug Ribavirin is already in the market in use for other     indications. It has been found useful in West Nile encephalitis and various hemorrhagic     fevers caused by related arboviruses. This is a double blind placebo of Ribavirin in Japanese     encephalitis. To the best of our knowledge, this is the first such trial in the world. The     study hypothesis is that children treated with ribavirin will be no different from those     getting placebo in terms of mortality, length of hospital stay, days to return to     consciousness and oral feeds, days to become afebrile and convulsion free and in 3 month     sequelae rate.   "
181359|NCT00216281|"     This is a randomized, placebo-controlled study to assess the efficacy and safety of ATX     augmentation of CLZ as a treatment for the cognitive symptoms of schizophrenia. A total     sample size of 126 subjects diagnosed with schizophrenia and being treated with the     antipsychotic clozapine will undergo genotyping. These subjects will have an initial     assessment at four weeks and regular follow-up assessments for a total period of 52 weeks.     These subjects will be randomized to continued treatment with CLZ and augmentation with ATX     or Placebo.   "
181360|NCT00216294|"     The purpose of this study is to determine the safety and tolerability of RG1068 (Synthetic     Human Secretin) when administered three times weekly to outpatients with obsessive compulsive     disorder (OCD), to determine the impact of multiple subcutaneous injections of RG1068 on the     symptoms of OCD, as measured by changes in clinical scales, and to evaluate the effect of     RG1068 on ODC patients' anxiety, quality of life, and depression.   "
181361|NCT00216320|"     To assess the effectiveness of a new stimulator (WalkAide) for the treatment of foot drop.     The comparison will involve physical measurements (e.g. walking speed, physiological cost     index, Modified Rivermead Mobility Index, etc.) and questionnaires on the quality of life and     acceptance of the technology by stroke survivors.   "
181362|NCT00216333|"     The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National     Tuberculosis Programmes has been recommended by both the International Union Against     Tuberculosis and Lung Disease (The Union) and the World Health Organisation. The advantages     of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing     the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding     adherence and facilitating directly observed treatment. Recent bioavailability studies of     four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing     the efficacy of this compound, when given in the initial intensive phase of treatment of     patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by     four months treatment with a two-drug FDC of rifampicin and isoniazid.   "
181363|NCT00216346|"     Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard     therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for     the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with     anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in     the treatment of patients with VL in India.   "
181364|NCT00216359|"     The Radata-Fuzeon cohort is an observational cohort study to gain a better understanding of     Fuzeon (Enfuvirtide) in daily clinical practice. Patients planned to take this drug in a new     antiretroviral combination therapy (ART) are eligible to participate in this observation.      Physicians may register patients online via the internet. They are offered to get an expert     advice suggesting therapeutics for a new ART.      Observation interval is every three month. However physicians are allowed to initiate new     diagnostics, expert advice and therapeutic changes independently from these intervals if     necessary.      Total observation time for each patients is planned for two years.   "
181365|NCT00216372|"     The purpose of this study is to determine whether lanreotide 30mg microparticles are     effective in the relief of clinical symptoms due to small bowel obstruction in inoperable     patients with peritoneal carcinomatosis.   "
181366|NCT00216385|"     Tuberculosis is currently treated with a 6-month course regimen. During this time many     patients might fail to adhere to treatment and default, increasing the risk of recurrent     disease which might be multidrug resistant. A shorter duration of treatment is expected to     provide improved patient compliance and at least equal or better clinical outcome. The aim of     the trial is to evaluate the efficacy and safety of a gatifloxacin-containing regimen of four     months duration for the treatment of pulmonary tuberculosis,   "
181367|NCT00216398|"     The purpose of this study is to assess the efficacy, safety and patient acceptability of     Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.   "
181368|NCT00216411|"     The main purpose of this study is to assess the effect on Quality of Life of two cycles of     Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on     spasticity and function will also be measured.   "
181369|NCT00216424|"     This study is designed primarily to establish efficacy and estimate resource utilization. The     short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week)     during the course of radiation therapy is efficacious in locally advanced, non-metastatic     rectosigmoid carcinoma and will improve resectability. The long-term working hypothesis is     that if 3-D CRT is combined with the potentiating and additive effect of capecitabine one     hopes to see improved and durable tumor response and survival with acceptable toxicity. In     addition, it is expected that the simplicity of using an oral agent (capecitabine) will be     associated with reduced cost and resource utilization.   "
181395|NCT00216762|"     This study is being done to find out if a drug called Rituxan (Rituximab) is safe and     effective in treating people with chronic urticaria (hives) with persistent symptoms in spite     of taking antihistamines.   "
181396|NCT00216775|"     The purpose of this study is to evaluate the efficacy and safety of low-dose     interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in     patients with chronic hepatitis C.   "
181463|NCT00217646|"     This randomized phase I trial is studying the side effects and best dose of two different     schedules of sorafenib in treating patients with refractory or relapsed acute leukemia,     myelodysplastic syndromes, or blastic phase chronic myelogenous leukemia. Sorafenib may stop     the growth of cancer cells by blocking some of the enzymes needed for cell growth and by     blocking blood flow to the cancer.   "
181397|NCT00216788|"     In a related study, the investigators have found evidence that patients with Barrett's     esophagus have a leak for oral sucrose to leave their upper gastrointestinal tract, enter the     blood, and be filtered into urine. The amount of sucrose appearing in an overnight urine     sample can be used to indicate the presence of Barrett's esophagus and/or esophagitis in a     patient reporting with reflux (GERD) symptoms. The leak is presumably in the Barrett's     epithelium itself. This phenomenon will be used to test if a standard 8 week therapy of     Nexium in a first-time-presenting GERD patient can reduce the leak as a means of assessing     the efficacy of the drug in that patient. The investigators predict that Nexium will reduce     leak in esophagitis but not Barrett's patients.   "
181370|NCT00216437|"     Our long-term working hypothesis is that if 3-D radiation is combined with the effect of     capecitabine one hopes to see improved and durable tumor response and survival with     acceptable toxicity. The primary objective is to determine the maximum tolerated dose of     capecitabine used along with 3-D conformal radiation therapy.      Capecitabine will be taken by mouth each day of radiation. The total daily dose should be     taken as two divided doses approximately 12 hours apart, within 30 minutes after eating,     ideally after breakfast and the evening meal. The overall total number of patients expected     to participate in this study could be as high as 30 depending on how the treatment is     tolerated.      The first group (3-6 patients) on the study will receive the drug (Xeloda®) at 600mg/m²     (level 1) and radiation. If the first group does well, the second group of patients on the     study (3-6 patients) will receive 825 mg/m² (level 2) and radiation. If the second group does     well, the third group will receive 1,000 mg/m² (level 3) and radiation. If the first dose     level of 600mg/m² is NOT tolerated, we will reduce the dose to 500mg/m² and enroll another     3-6 patients at the lower dose.      After the highest tolerated dose is identified, 12 additional patients will be treated at     that dose to further test the safety of the treatment and better understand the effects of     the treatment on disease with more patients.      The following tests and procedures are part of regular medical treatment (standard care) for     the disease and are also required for this study.        -  physical examinations        -  blood tests including pregnancy test        -  urinalysis        -  ECG (heart tracing)        -  chest X-ray        -  CT scan of the abdomen      Follow-up visits are done 1 month after radiation, then 3 months later, then every 3 months     for 2 years.   "
181371|NCT00216450|"     The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the     treatment of adult patients with Helicobacter pylori (H. pylori) infection in routine     clinical practice.   "
181372|NCT00216463|"     The aim of this study is to assess the safety and tolerability of varying dose and load     regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.   "
181373|NCT00216476|"     The purpose of this study is to investigate whether a long-acting injectable formulation of     risperidone provides better effectiveness over 2 years, as measured by the time to relapse,     compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be     investigated in a descriptive manner.   "
181374|NCT00216489|"     The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the     treatment of patients with erosive or ulcerative gastroesophageal reflux disease (GERD) in     routine primary health care.   "
181375|NCT00216502|"     The purpose of this study is to evaluate the long-term efficacy and safety of galantamine in     patients with Alzheimer's disease.   "
181376|NCT00216515|"     The purpose of this study is to assess the efficacy of galantamine on the attention of     patients with Alzheimer's Disease, how an improvement of attention of Alzheimer's Disease     patients affects their activities of daily living, and the global benefit of galantamine.   "
181377|NCT00216528|"     The purpose of this study is to evaluate symptomatic remission rate in patients with     schizophrenia using long acting risperidone microspheres   "
181378|NCT00216541|"     The purpose of this study is to evaluate the effect of early treatment with epoetin alfa in     addition to best standard of care on hemoglobin levels and the need for red blood cell     transfusions in cancer patients receiving chemotherapy as compared to patients receiving     standard epoetin alfa treatment and best standard of care.   "
181379|NCT00216554|"     The purpose of this study is to evaluate effect of risperidone as a long-term combination     therapy to mood stabilizers in the treatment of bipolar mania   "
181380|NCT00216567|"     The purpose of this study is to determine the efficacy and safety of Topiramate in comparison     to Carbamazepine in Benign rolandic epilepsy.   "
181381|NCT00216580|"     The purpose of the study is to assess the effectiveness and safety of long-acting injectable     risperidone in the treatment of patients in the early stage of psychosis   "
181382|NCT00216593|"     The purpose of this study is to assess the effectiveness and safety of galantamine     hydrobromide treatment in patients with severe Alzheimer's disease.   "
181383|NCT00216606|"     The purpose of this study is to evaluate the safety and effectiveness of individualized doses     (50 to 200 milligrams) of topiramate tablets compared against placebo for the prevention of     chronic migraine headaches over a period of 16 weeks.   "
181384|NCT00216619|"     The purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of     individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine     headaches over a period of 26 weeks.   "
181385|NCT00216632|"     The purpose of the study is to evaluate the maintained effectiveness of long-acting     injectable risperidone (RISPERDAL® CONSTA™) compared with the previous treatment with oral     olanzapine in non-acute subjects with schizophrenia or schizoaffective disorder considered in     need of a therapy change.   "
181386|NCT00216645|"     The purpose of this study is to assess the effectiveness and safety of pegylated liposomal     doxorubicin hydrochloride injection in Japanese patients with Mullerian carcinoma. This     clinical study is a multi-center, non-randomized, open-label study in Japanese patients with     Mullerian carcinoma (including epithelial ovarian carcinoma, primary carcinoma of fallopian     tube, peritoneal carcinoma) with a prior history of platinum-based chemotherapy. Eighty     patients will be administered intravenously at least two cycles of 50 mg/m2 of pegylated     liposomal doxorubicin hydrochloride every 4 weeks to investigate the effectiveness and safety     of the treatment.   "
181387|NCT00216658|"     The purpose of this study is to verify the effectiveness, safety and pharmacokinetics of     fentanyl transdermal matrix patches containing either 12.5 mcg/hr, 25 mcg/hr, or 50 mcg/hr in     Japanese patients with cancer pain who have been switched from minimum amount of existing     morphine preparations, such as equivalent to less than 45 mg/day of oral morphine, or oral     oxycodone preparations equivalent to less than 30 mg/day.   "
181388|NCT00216671|"     The primary objective of this randomized trial was to investigate whether early initiation of     treatment with Risperdal Consta after an acute episode was not inferior to the routine     approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .   "
181389|NCT00216684|"     The purpose of this study is to verify the effectiveness, and safety in Japanese patients     with chronic intractable pain after 4-week medication of fentanyl transdermal matrix patches     containing either 12.5 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, or 100 mcg/hr, who have been     switched from existing formulations, such as codeine, morphine hydrochloride, or fentanyl     injectable. Furthermore, the safety and effectiveness of long term treatment such as 48 weeks     are to be assessed, if possible.   "
181390|NCT00216697|"     One purpose of this study is to evaluate the effectiveness and safety in long term treatment     for patients who completed preceding phase I/II study. The other purpose is to evaluate the     effectiveness and safety of patients who are re-treated with this drug in recommended dose.   "
181400|NCT00216827|"     The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of     calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more     effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50     mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.      The primary outcome is the proportion of patients with absence of disease or very mild     disease after 8 weeks of treatment.   "
181401|NCT00216840|"     The purpose of the study is to evaluate whether once daily topical treatment for up to 8     weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and     more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and     calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis.      The primary response criterion is the number of patients with absence of disease and very     mild disease after 8 weeks of treatment.   "
181402|NCT00216853|"     The purpose of this study is to determine the extent to which vaginal microflora and immune     profiles of patients with urinary tract infection (UTI) differ from healthy controls.   "
181403|NCT00216866|"     The purpose of this study is to obtain an estimate of catheter survival in the setting of     upper extremity deep vein thrombosis (UEDVT) in patients treated with dalteparin and     warfarin.      Anticoagulation with dalteparin and warfarin in patients with UEDVT secondary to central     venous catheters in patients with an active malignancy is an effective therapy as quantified     by the success of catheter preservation. A prolonged line salvage rate without a recurrence     of UEDVT will improve the management of cancer patients who develop upper extremity deep     venous thrombosis in the setting of a central venous (CV) catheter.   "
181404|NCT00216879|"     The purpose of the trial is to study the safety and efficacy of long term use of once daily     applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to     calcipotriol alone in the same gel.      The primary response criteria will be the incidence of adverse drug reactions of any type,     and the incidence of adverse events of concern associated with long-term corticosteroid use     on the scalp.   "
181405|NCT00216892|"     Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with:        1. 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8          weeks of calcipotriol cream        2. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks          of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate)          ointment on weekends        3. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks          of vehicle of calcipotriol cream      The objective is to compare the efficacy and safety of the different treatment regimens   "
181406|NCT00216905|"     Investigation of inpatients with alcoholism after detoxification with simultaneous     Electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI).   "
181407|NCT00216918|"     The purpose of this study is to evaluate the change in neuropsychological status from     baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5     diagnosed with ADHD.   "
181408|NCT00216931|"     The purpose of this study is to determine if iloprost is effective in the treatment of     elevated arterial pulmonary pressure in children with ventilator treated respiratory distress     syndrome.   "
181409|NCT00216944|"     The study aim is to compare a balanced anesthesia of the medicines used in all other age     groups with the routine premedication in use for premature's with regards to the success in     the intubation procedure, the need for analgesia during and after intubation and the stress     reaction. In addition a pain scale for prolonged stress/pain for premature neonates in     NICU-care will be validated, and the individual pharmacogenetic profile in relation to the     need of morphine after the intubation will be investigated. The hypothesis is that balanced     anesthesia before intubation facilitates the procedure, decreases the amount of stress and     pain related to it, and causes a decreased need for analgesia after the intubation.   "
181410|NCT00216957|"     Coronary artery bypass grafting (CABG) is a well established treatment modality for patients     with coronary artery disease. For 30 years now CABG operations have been performed with the     help of the heart lung machine (Cardiopulmonary bypass). However, the heart lung machine is     believed to be responsible for many of the side effects and complications seen in patients     following CABG surgery. The organs most commonly affected are the brain, blood constituents,     lungs and kidneys.      In the last few years, stabilising devices have been developed that allow CABG operations to     be performed safely without the use of the heart lung machine. Our hypothesis was that CABG     done without the heart lung machine may be better tolerated by patients resulting in lower     morbidity, increased functional outcome and shorter hospital length of stay.      Enrolment into the trial was from 1998 to 2003 and included 300 patients. The last patient     was enrolled in June of 2003. The initial results from the study suggest that excellent     results can be obtained with both techniques and contrary to others no advantages could be     demonstrated in in-hospital outcomes of patients performed without cardiopulmonary bypass     (Legare et al. Circulation 2005).   "
181411|NCT00216970|"     The purpose of the study is to understand the way the body uses amino acids and proteins in     burned patient during the time they cannot eat normally. This study aims to understand the     metabolism of the amino acid arginine in the body after burn injury. The results of this     study will help determine the best composition of food needed during an acute burn injury so     that body can more efficiently use the supplied nutrient for optimal burn wound healing and     early recovery.   "
181412|NCT00216983|"     The overall purpose of the study is to evaluate the effect of depleting proline supply in the     nutritional support regimen on proline metabolism in the burn patients, this includes the     rate of proline oxidation after burn injury, the rate of proline de novo synthesis from its     immediate precursors glutamate and ornithine. The specific aims of the proposed study are: 1)     to determine the kinetic status of proline metabolism and whole body proline balance under     the following nutritional states: (a) fasting; (b) regular total parenteral nutrition (TPN);     (c)TPN with isonitrogenous depletion of proline, glutamate and ornithine metabolism under     nutritional conditions studied in specific aim 1) above.   "
181424|NCT00217139|"     The objective of the study is to evaluate the safety and efficacy of celgosivir plus     peginterferon alfa-2b, with or without ribavirin, for 12 weeks in patients with chronic     hepatitis C genotype 1 infection.   "
181413|NCT00216996|"     The Total Parenteral Nutrition (TPN)received as part of your routine burn care has optimal     levels of protein and sugar, however the best mixture of amino acids for a patient with burn     wounds is not yet known. Amino acids occur naturally in the body and the food we eat. The     body combines amino acids to make protein. It uses the proteins to do things such as heal     wounds, fight infection, and provide energy. We are studying if the body's use of protein is     increased after receiving TPN containing the amino acid called glutamine. We hope to learn     the best composition of TPN so that the body can more efficiently repair wounded tissues and     recover earlier from an acute burn injury.   "
181414|NCT00217009|"     Hand and foot skin diseases, such as dermatitis and psoriasis, that do not respond to topical     creams can be treated with ultraviolet light therapy. Topical psoralen plus ultraviolet A     (PUVA) is commonly used to treat these conditions, but requires additional time for the hands     and feet to soak in psoralens before the light treatment. Newer narrowband ultraviolet B     (NBUVB) units have become available which allow for light treatment without soaking first.     The purpose of this study is to determine if NBUVB is as effective as PUVA for hand and foot     skin diseases.   "
181415|NCT00217022|"     Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis.     This study includes stool collections, blood draws, weekly questionnaires and a     sigmoidoscopy. The study hypothesis is that budesonide will be safe and effective compared     with placebo for the treatment of diarrhea in lymphocytic colitis.   "
181416|NCT00217035|"     Proline is a non-essential amino acid that helps with collagen formation. Collagen is one of     the main ingredients of skin, bone, tendons, and connective tissue. It is thought that     proline becomes depleted in burn patients because it is being used in greater than normal     quantities to help the injured skin and connective tissue heal. If this is true, then the     body must look for alternate energy sources as proline becomes depleted.      This study aims to evaluate 1)the metabolic kinetics of the amino acids proline, glutamate,     and ornithine and 2) the effects of glutamine supplemented total parenteral nutrition (TPN)     on the metabolism of these amino acids.   "
181417|NCT00217048|"     This study is being done to learn if yohimbine, a naturally occurring drug, affects the speed     at which food travels through the stomach, intestines and colon, and if yohimbine affects the     amount of liquid you can drink in a short period of time. Understanding how yohimbine works     on the gut may help develop new treatments for patients with constipation. Yohimbine has been     approved by the Food and Drug Administration (FDA) for routine clinical use, however, its use     as proposed in this study is considered investigational.   "
181418|NCT00217061|"     Background- Statins are a safe and effective therapy to reduce cardiovascular risk in     patients with type 2 diabetes; however some patients are not prescribed statins, others do     not take it even after being prescribed, and others stop therapy prematurely. Lack of     knowledge or misinformation about statins may be responsible for inadequate statin use.      Objective- To test the hypothesis that a formal, structured decision aid could correct     deficiencies in the current decision-making process, increase statin use, and improve     outcomes in patients with type 2 diabetes.      Methods - The investigators will develop a decision aid called STATIN CHOICE and will pilot     its efficacy in a blinded randomized controlled trial enrolling 98 type 2 diabetes patients.      Outcomes- Primary outcomes: adherence to the decision to use or not to use statins three     months after using STATIN CHOICE. Secondary outcomes: acceptability of STATIN CHOICE,     knowledge about options, satisfaction with decisions, decisional conflict, encounter     duration, and quality of life.      Expected results- The investigators anticipate that this work will yield an effective and     innovative decision aid for statin use in type 2 diabetes patients. STATIN CHOICE, along with     a detailed users manual, will be directly applicable in clinical practice. Data and     experience from this project will inform the planning and conduct of a randomized multicenter     trial of the effectiveness of STATIN CHOICE in diverse practice settings.      Significance- Patient participation in decision-making resulting in informed treatment     decisions, as proposed in this study, will likely lead to improved quality of     decision-making, more appropriate use of statins, and improved patient outcomes.   "
181419|NCT00217074|"     Methods: 103 participants, after being randomized to medical versus sham acupuncture received     bi-weekly treatments for 5 weeks, after a baseline assessment week. They were then followed     for an additional 7 weeks. Participants completed daily hot flash questionnaires, which     formed the basis for analysis.   "
181420|NCT00217087|"     This study is being done to see if treatment for esophageal cancer can be done using     endoscopy for patients ineligible for surgical or radiological therapy. The standard method     of treating this type of cancer is surgical removal of the esophagus. The study will     determine if removing just the cancer with endoscopy is enough treatment or if the addition     of another treatment called photodynamic therapy (treatment with a red light and a drug     called sodium porfimer) is needed.   "
181421|NCT00217100|"     This study is being done to compare arteriosclerotic cardiovascular disease in kidney     transplant recipient taking a standard multivitamin versus those taking a multivitamin     augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6.   "
181481|NCT00217906|"     This project will evaluate the effectiveness of a Head Start-based early intervention for     designed to improve asthma management skill and practices of parents, pre-school children and     Head Start staff.   "
181422|NCT00217113|"     This is a study aimed at identifying Olmsted County senior citizens who are at risk for     vulnerability. Those elders who screen affirmatively for vulnerability will be offered     participation in a pilot intervention aimed at keeping seniors independent in the community.     This intervention consists of a comprehensive geriatric home visit and the development of an     individualized action plan aimed at preservation of function and independence. Participants     will be followed for several months after their baseline assessment to evaluate     implementation of recommendations.   "
181423|NCT00217126|"     This study is being done to create a kidney transplant database with information from many     transplant centers for the purpose of studying ways to help improve transplant outcomes and     the care of transplant recipients. This is also being done to learn why kidney transplant     recipients have worsening of their kidney function, and whether there are specific findings     that could result in future treatments.   "
189824|NCT00322634|"     The use of performance status and LDH in combination can predict patient survival more     accurately than physician clinical impression or the patients' own feelings about their     survival   "
181425|NCT00217152|"     This research is being done to study the effects (good and bad) of taking CellCept based on     blood concentrations versus taking a fixed dose of CellCept without measuring the blood     concentration. CellCept is one of the three immunosuppressant drugs (drugs that suppress the     immune system) which will be taken as part of this kidney transplant study. Cyclosporine or     tacrolimus and corticosteroids are the two other drugs which will be taken.   "
181426|NCT00217165|"     The purpose of this study is to determine whether the amino acid taurine has effects on mood     stability in bipolar disorder.   "
181427|NCT00217178|"     Study Objective:      1. To evaluate whether combined therapy with folic acid 2.5 mg/day, vitamin B6 50 mg/day and     vitamin B12 1000 micrograms/day vs placebo reduces the rate of atherosclerosis progression,     as evaluated by quantitative B-mode carotid ultrasound (US).   "
181428|NCT00217191|"     Purpose of the study:        1. To evaluate renal function maturation within the first month of life in very premature          infants.        2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter          renal function maturation at short term and up to 28 days of life.   "
181429|NCT00217204|"     The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT     (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in     infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess     whether the consistency of the microtablets is acceptable for swallowing in infants and     toddlers   "
181430|NCT00217217|"     Individuals with bipolar depression who had a particular kind of brain imaging reported     improved mood after the imaging. This effect may be linked to the changing magnetic fields     used during these magnetic resonance imaging studies. The current studies are designed to     further explore the important parameters of this effect and to clarify the degree and     duration of the mood effects.   "
181431|NCT00217230|"     The purpose of this study is to determine the efficacy, safety and tolerability of the liquid     formulation of CAIV-T against culture confirmed influenza illness in adults aged 60 years and     older. In addition this study aims to demonstrate superiority of CAIV-T when compared with     placebo and the effect on economic resources.   "
181432|NCT00217243|"     In order to be able to study the effects of evoked fields with magnetoencephalography (MEG)     in two groups of patients, comparison is made with a group of healthy volunteers.   "
181433|NCT00217256|"     To demonstrate the equivalency in in-segment late lumen loss at 8 months between the Endeavor     Drug Eluting Coronary Stent System coated with ABT-578 (10 micrograms/mm) and the Cypher     Sirolimus-Eluting Coronary Stent System for the treatment of single de novo lesions in native     coronary arteries 2.5-3.5 mm in diameter.   "
181434|NCT00217269|"     The purpose of this study is to assess the equivalence in safety and efficacy of the Endeavor     Drug Eluting Coronary Stent System when compared to the Taxus Paclitaxel-Eluting Coronary     Stent System for the treatment of single de novo lesions in native coronary arteries with a     reference vessel diameter (RVD) of 2.5-3.5 mm.   "
181435|NCT00217282|"     The combination of oxaliplatin and gemcitabine has proven activity in advanced non-small cell     lung cancer (NSCLC). Due to its favorable toxicity profile, this combination is optimal for     adding new agents. Bevacizumab is an anti-VEGF monoclonal antibody that has also shown     favorable results in advanced NSCLC. This study will add bevacizumab to oxaliplatin and     gemcitabine as first line treatment in patients with Stage IIIB and IV NSCLC.   "
181436|NCT00217295|"     This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax     added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction (     a measure of brain shrinkage) and by clinical assessment scores to evaluate disease     progression.   "
181438|NCT00217321|"     The purpose of the Parkinson's disease Registry is to develop a national and international     database of persons with Parkinson's disease (PD). The Registry will be used to facilitate     the development of new therapies and healthcare services to improve the quality of life for     people with PD. It will also be a means for investigators in the field of PD to quickly     identify and notify subjects about other research studies for which they are eligible.      Objectives include:        -  Assess current treatment approaches and develop best-practice guidelines        -  Track the functional abilities, access to healthcare and cost of illness of people with          PD over time        -  Drive the development of innovative research projects        -  Accelerate the process of informing patients of research projects for which they may be          eligible   "
181439|NCT00217334|"     The Community Hypertension Assessment Trial (CHAT) is an investigation of the effect of     community pharmacy based blood pressure (BP) monitoring sessions led by peer health     educators, with feedback to family physicians, on the monitoring and management of blood     pressure among older adults.   "
181449|NCT00217464|"     RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using     fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells.      PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with     recurrent prostate cancer.   "
181440|NCT00217347|"     The exploration of evocative symptoms of esophageal reflux disease or dyspepsia is based on a     relatively invasive endoscopic examination, often badly tolerated, and which, in France, is     carried out in 50% of the cases under general anaesthesia. The development of a Capsule     Endoscopy, of single use, of esophageal exploration (PILLCAM OESO), could allow a painless     exploration of the oesophagus, without infectious risk.The aim of this study is to validate     the information provided by the Esophageal Capsule Endoscopy compared to upper endoscopy in     the screening of patients with gastroesophageal reflux disease or dyspepsia . For that these     patients, after being informed and to have given their signed assent, will initially have an     exploration by Esophageal Capsule Endoscopy and then, the very same day or within 3 days     maximum, a upper endoscopy'. The information provided by the Esophageal Capsule Endoscopy     then by the upper endoscopy will be analyzed by investigators different. This study should     make it possible to evaluate the parameters of specificity, sensitivity and predictive values     of Esophageal Capsule Endoscopy in this indication.   "
181521|NCT00206362|"     The purpose of this study is to learn about the relationship that exists between coping     skills and blood glucose control. In addition to this, we will study the effect of type 1     diabetes on coping skills in different age groups, genders, ethnicities, socioeconomic     groups, and the duration of diabetes.   "
181441|NCT00217360|"     This project is called “Falls Aren’t Us” and aimed at evaluating the effectiveness of a     customised falls prevention program for people aged 60 and over who were presented to the     hospital Emergency Department following a fall and being discharged home. Recruitment for     this randomized controlled trial has commenced in late December 2002 from several major     public hospitals in the western, southern, and northern parts of Melbourne Metropolitan     Region. Consented participants will receive a comprehensive falls risk assessment within one     week of being discharged home from the Emergency Department and at twelve month following     this initial assessment. Their falls risks will be monitored for twelve months through a     falls diary. Following randomization, participants in the intervention group will receive a     customised falls prevention program in addition to the usual care being put in place from the     hospital Emergency Department.   "
181442|NCT00217373|"     This phase I trial is studying the side effects and best dose of interferon alfa-2b when     given together with vaccine therapy and GM-CSF in treating patients with locally advanced or     metastatic cancer that makes CEA. Vaccines made from a gene-modified virus may help the body     build an effective immune response to kill cancer cells that make carcinoembryonic antigen     (CEA). Biological therapies, such as GM-CSF, may stimulate the immune system in different     ways and stop cancer cells from growing. Interferon alfa-2b may interfere with the growth of     cancer cells and slow cancer growth. Giving vaccine therapy together with GM-CSF and     interferon alfa-2b may kill more cancer cells that make CEA.   "
181443|NCT00217386|"     RATIONALE: Biological therapies, such as anti-thymocyte globulin and etanercept, may     stimulate the immune system in different ways and stop cancer cells from growing. Giving     anti-thymocyte globulin together with etanercept may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together     with etanercept works in treating patients with myelodysplastic syndromes.   "
181444|NCT00217399|"     Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by     blocking some of the enzymes needed for cell growth. Estradiol can cause the growth of breast     cancer. Hormone therapy using anastrozole may fight breast cancer by blocking the use of     estradiol by the tumor cells. Sometimes when hormone therapy is given, it does not stop the     growth of tumor cells. The tumor is said to be resistant to hormone therapy. Giving sorafenib     together with anastrozole may reduce drug resistance and allow the tumor cells to be killed.     This phase I/II trial is studying the side effects and best dose of sorafenib when given in     combination with anastrozole and to see how well they work in treating postmenopausal women     with metastatic breast cancer.   "
181445|NCT00217412|"     This phase I trial is studying the side effects and best dose of vorinostat when given     together with isotretinoin in treating young patients with recurrent or refractory solid     tumors, lymphoma, or leukemia. Drugs used in chemotherapy, such as vorinostat, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Vorinostat may also stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth and by blocking blood flow to the cancer. Isotretinoin may     cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving     vorinostat together with isotretinoin may be an effective treatment for cancer.   "
181446|NCT00217425|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the     growth of cancer cells by blocking blood flow to the cancer. Drugs used in chemotherapy work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving bevacizumab together with combination chemotherapy may     kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with several     chemotherapy drugs (combination chemotherapy) works in treating patients with peripheral     T-cell lymphoma or natural killer cell neoplasms.   "
181447|NCT00217438|"     RATIONALE: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.     Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of     chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice, using     stem cells from the patient or an identical brother or sister, may allow more chemotherapy to     be given so more cancer cells are killed. Giving maintenance therapy after a stem cell     transplant may kill any cancer cells that remain. It is not yet known which dose of melphalan     is more effective in treating multiple myeloma (MM).      PURPOSE: This randomized phase III trial is studying two different doses of melphalan to     compare how well they work when given together with amifostine followed by one or two     autologous or syngeneic stem cell transplants and maintenance therapy in treating patients     with stage II-III MM   "
181448|NCT00217451|"     Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic     that has been shown to be effective against malaria, although it cannot achieve a total cure     in all patients. A previous small study has shown that in combination with clindamycin, an     commonly used antibiotic, it is highly effective and safe, in asymptomatic carriers of     malaria parasites. The current study will evaluate the efficacy and safety of the combination     given for three days in children with uncomplicated malaria in Gabon.   "
181450|NCT00217477|"     RATIONALE: Paricalcitol may cause cancer cells to look more like normal cells, and to grow     and spread more slowly. Drugs used in chemotherapy, such as gemcitabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving paricalcitol together with gemcitabine may be an effective treatment for     cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of paricalcitol when     given together with gemcitabine in treating patients with advanced cancer.   "
181451|NCT00217490|"     RATIONALE: Eating a diet high in fruits and vegetables and low in fat may lower the risk of     some types of cancer. Dietary counseling may be effective in helping women change to a     healthy diet.      PURPOSE: This randomized clinical trial is studying how well individual counseling and/or     computer-based counseling work in helping healthy women adopt a cancer prevention diet.   "
181668|NCT00222547|"     Randomisation of 72 large rural areas (blocks) into a 2 x 2 trial of six- monthly treatment     of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or     neither. The placebo group get no trial treatment at all and do not receive physical     placebos.   "
181452|NCT00217503|"     RATIONALE: Herpesvirus is found in the cancer cells of patients with primary effusion     lymphoma. Antiviral drugs, such as zidovudine and valganciclovir, may be able to act against     the herpesvirus in the cancer cells to help kill the cancer cells. Bortezomib may help the     antiviral drugs kill the cancer cells. Draining the effusion removes fluid that has built up.     Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of     cancer cells by blocking blood flow to the cancer. Drugs used in chemotherapy, such as     cyclophosphamide, doxorubicin, and etoposide, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Giving     bortezomib together with antiviral therapy followed by effusion drainage, bevacizumab, and     combination chemotherapy may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with antiviral     therapy followed by effusion drainage, bevacizumab, and combination chemotherapy works in     treating patients with primary effusion lymphoma.   "
181453|NCT00217516|"     RATIONALE: The use of nutritional supplements, such as selenium, may stop prostate cancer     from growing. Internal radiation, such as brachytherapy, uses radioactive material placed     directly into or near a tumor to kill tumor cells. Giving selenium before brachytherapy may     be an effective treatment for prostate cancer.      PURPOSE: This randomized phase I trial is studying selenium to see how well it works compared     to placebo in treating patients who are undergoing brachytherapy for stage I or stage II     prostate cancer.   "
181454|NCT00217529|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as docetaxel and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving erlotinib together with docetaxel and carboplatin may     kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when     given together with docetaxel and carboplatin and to see how well they work in treating     patients with newly diagnosed stage III or stage IV ovarian epithelial, primary peritoneal     cavity, or fallopian tube cancer.   "
181455|NCT00217542|"     This phase I trial is studying the side effects and best dose of recombinant interferon     alfa-2b when given together with azacitidine in treating patients with stage III or stage IV     melanoma or stage IV kidney cancer that cannot be removed by surgery. Drugs used in     chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Recombinant interferon alfa-2b     may interfere with the growth of tumor cells. Giving azacitidine together with recombinant     interferon alfa-2b may kill more tumor cells.   "
181456|NCT00217555|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and topotecan, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with topotecan     works in treating patients with recurrent or persistent ovarian, fallopian tube, or primary     peritoneal cavity cancer.   "
181457|NCT00217568|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin     works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary     peritoneal cavity cancer.   "
181458|NCT00217581|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of     tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as     oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving bevacizumab together with     oxaliplatin and docetaxel may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with     oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or     metastatic stomach or gastroesophageal junction cancer.   "
181459|NCT00217594|"     This study will evaluate the safety and effectiveness of a genetically engineered antibody,     alemtuzumab (Campath[R]) on patients with myelodysplastic syndrome. MDS is made up of     malignant stem cell disorders that can mean low levels of red blood cells-that is, anemia-and     low counts of white blood cells and platelets. Patients with MDS are at risk for infection,     spontaneous bleeding, and possible progression to leukemia, a cancer of bone marrow. Although     bone marrow can produce some blood cells, patients with MDS experience a decrease in     production of blood cells. Alemtuzumab recognizes specific types of white cells called     lymphocytes and destroys them. This study will examine not only the usefulness of the     medication but also the side effects in patients with MDS.      Patients ages 18 to 72 who have MDS that requires transfusions and who do not have HIV or a     life expectancy of less than 6 months may be eligible for this study. Screening tests include     a complete physical examination and medical history. There will be a collection of about 8     tablespoons of blood for analysis of blood counts as well as liver, kidney, and thyroid     function; a pregnancy test; an electrocardiogram (EKG) to measure electrical activity of the     heartbeat; an echocardiogram (ECHO), which uses sound waves to evaluate heart function;     wearing of a Holter monitor for 24 hours while the electrical activity of the heart is     recorded; and a bone marrow biopsy. Patients should not receive any vaccines when taking     alemtuzumab or for at least 12 months after the last dose. In addition, patients should not     take the herbal supplements Echinacea purpurea or Usnea 2 weeks before beginning the study     and during it.      For the study, all patients will receive a test dose of 1 mg of alemtuzumab infused into a     vein during the course of 1 hour. If the dose is tolerated, the medication will be given at     10 mg doses into the vein for 10 days, as an infusion of 2 hours. Blood samples of 2     tablespoons will be taken daily, and vital signs will be measured daily. The ECHO and 24-hour     Holter monitoring will be repeated after patients receive the last dose of the medication.     Because suppression of the immune system results from a decrease in white cells that fight     infections, patients will take medications to protect them against infections and to treat     them if infections occur. If needed, patients will receive blood transfusions for their MDS.     Side effects of alemtuzumab involve a temporarily significant lowering of the number of red     blood cells, white cells, and platelets. Side effects of the infusion can be rigidity, or     stiffness, and fever, as well as risks of infections resulting from the decrease of white     blood cells. Blood counts and reactions to all procedures will be carefully monitored     throughout the study. After patients receive the last dose of alemtuzumab, they will have     follow-up by their referring doctor or at NIH. They must be able to return to NIH after 1     month, 3 months, 6 months, and annually for 5 years after the study. At follow-up visits,     there will be blood tests to reevaluate blood counts and test for the presence of viruses.     Blood tests will be done weekly for the first 3 months after patients have completed taking     alemtuzumab, every other week until 6 months, and then annually for 5 years. There will also     be a repeat ECHO at the 3-month visit, and a repeat bone marrow biopsy at the 5-month and     12-month follow-up visits, and as needed after that.      This study may or may not have a direct benefit for participants. For some, the antibody may     improve blood counts and decrease the need for transfusions. Knowledge gained in the study     may help people in the future.   "
181460|NCT00217607|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with     locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be     removed by surgery.   "
181461|NCT00217620|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with     advanced soft tissue sarcomas.   "
181462|NCT00217633|"     This phase II trial is studying how well pelvic exenteration works in treating patients with     recurrent cervical cancer. Pelvic exenteration may be effective in treating recurrent     cervical cancer.   "
181567|NCT00212355|"     The purpose of this long-term study is to determine whether Zinc Acetate is effective and     safe in the treatment of Wilson's disease among Japanese.   "
181464|NCT00217659|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     goserelin and anastrozole may fight breast cancer by blocking the use of estrogen by the     tumor cells. Giving goserelin together with anastrozole may be an effective treatment for     male breast cancer.      PURPOSE: This phase II trial is studying how well giving goserelin together with anastrozole     works in treating men with recurrent or metastatic breast cancer.   "
181522|NCT00206375|"     The purpose of this study is to see if giving growth hormone and Lupron along with thyroid     hormone will improve final height in patients with long term hypothyroidism. Lupron is a     medicine which is used to delay puberty and to prevent early closure of growing bones which     might increase growth potential. Growth hormone is used to restore growth rate. This study     will include children with short term and long term hypothyroidism.   "
181465|NCT00217672|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor     cells by stopping blood flow to the tumor. It is not yet known whether giving docetaxel     together with bevacizumab is more effective than docetaxel alone in treating breast cancer.      PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with     bevacizumab works compared to docetaxel alone as first-line therapy in treating women with     stage IV breast cancer.   "
181466|NCT00217698|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and cisplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. Giving gefitinib as first-line therapy followed by gemcitabine and     cisplatin after disease progression may be an effective treatment for non-small cell lung     cancer.      PURPOSE: This phase II trial is studying how well gefitinib works as first-line therapy     followed by gemcitabine and cisplatin in treating patients with stage III or stage IV     non-small cell lung cancer.   "
181467|NCT00217711|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine     when given together with oxaliplatin and irinotecan and to see how well they work in treating     patients with advanced or metastatic colorectal cancer that cannot be removed by surgery.   "
181468|NCT00217724|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.     Nutritional supplements, such as glutamine, may prevent side effects caused by chemotherapy.      PURPOSE: This randomized clinical trial is studying glutamine to see how well it works     compared to placebo in preventing myalgia and/or arthralgia in patients who are receiving     paclitaxel for cancer.   "
181469|NCT00217737|"     This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and     bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and     fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs     used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as     bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet     known whether giving combination chemotherapy together with bevacizumab is more effective     than combination chemotherapy alone in treating colon cancer.   "
181470|NCT00217763|"     The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on     therapy to most standard medication for Alzheimer's disease compared to placebo (inactive     substance pill) in patients with mild to moderate Alzheimer's disease.   "
181471|NCT00217776|"     This random trial will deploy 2 interventions and a control group with eleven and twelve year     old, low income, African American students in middle schools in Detroit, MI. The goals are to     determine if 1) a self-management program focused on pre-teen capabilities designed for     middle schools produces desired outcomes, and 2) if the program, enhanced by a peer     component, improves upon outcomes. Outcomes of interest are symptom experience, quality of     life, self-management, and school grades.   "
181472|NCT00217789|"     The purpose of this study is to assess the lung cells of healthy volunteers and patients with     stage II and III pulmonary sarcoidosis for pathogen specific memory immunity and gene     expression patterns.   "
181473|NCT00217802|"     The project evaluates an innovative educational intervention using telephone counseling based     on self-regulation theory designed to address a problem heretofore overlooked in asthma     self-management education: the unique needs of adult female patients.   "
181474|NCT00217815|"     The study hypothesis is that the addition of Mycograb to docetaxel will improve outcome in     advanced carcinoma of the breast.   "
181475|NCT00217828|"     To evaluate the therapeutic effects of the serotonergic agent, citalopram, on hostility and     other behavioral risk factors, and biological markers of disease risk (serum lipids, insulin     and glucose; autonomic balance and stress-related cardiovascular reactivity; platelet     activation).   "
181476|NCT00217841|"     The study hypothesis is that the addition of Aurograb to standard vancomycin therapy will     improve outcome in MRSA infection.   "
181477|NCT00217854|"     The purpose of this study is to examine inflammatory processes in the airway of moderate to     severe persistent asthmatics who have persistent bronchial hyperreactivity despite chronic     administration of inhaled glucocorticoids.   "
181478|NCT00217867|"     This study will use a comprehensive hospital discharge toolkit to implement up-to-date     guidelines for cardiopulmonary diseases. The study will also include a computer-based     patient-education program and a telephone-based post-discharge program, both designed for     individuals with limited health literacy. The purpose of this study is to reduce early     hospital readmission.   "
181479|NCT00217880|"     The purpose of this study is to identify biological markers of disease in patients with acute     lung injury (ALI) that are predictive of either disease susceptibility or prognosis, or that     identify novel targets of therapeutic intervention.   "
181480|NCT00217893|"     This study will determine the effect of combining counseling, urine cotinine feedback, and     incentives in reducing environmental tobacco smoke (ETS) exposure and susceptibility to     smoking among high-risk preteens.   "
181571|NCT00218439|"     Smokers report that they often smoke cigarettes during stressful times. The combined effect     of smoking and exposure to stress leads to exaggerated increases in blood pressure, heart     rate and other measures of stress response. This combination may result in greater     cardiovascular harm than either smoking or stress alone. The purpose of this study is to     determine the effects of paroxetine on the response to stress after smoking.   "
181484|NCT00217945|"     To evaluate a model of shared decision-making for asthma treatment, appropriate to the needs     of African American, Latino, Chinese, and other Asian and low income Caucasian patients to     adherence to asthma controller medications in a two-year randomized clinical trial in 302     minority and low-income adults, 18-70 years of age, with suboptimally controlled, persistent     asthma, paralleling a simultaneous evaluation being conducted in 311 Caucasian and     Asian/Pacific Island adults, (total n=613), and to examine psychological mechanisms mediating     the effects of the intervention on adherence and of adherence on asthma outcomes.   "
181485|NCT00217958|"     To improve disease outcomes through reduction in secondhand tobacco smoke exposure of     children with asthma   "
181486|NCT00217971|"     The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana     addiction and withdrawal.   "
181487|NCT00217984|"     The purpose of this study was to determine the efficacy and cost-effectiveness of an     intensive smoking cessation intervention that utilizes extended cognitive-behavioral therapy     and combination nicotine replacement (CNR) in a randomized controlled trial. The intensive     intervention was compared to usual care involving referral to a free-standing smoking     cessation program that provides brief counseling and CNR. We recruited 162 smokers, ages 18     to 75, who are enrolled in the Drug and Alcohol Treatment (DAT) programs at the San Francisco     VA Medical Center (SFVAMC) and Santa Rosa VA Community-based Outpatient Clinic (CBOC). To be     eligible, participants had to be abstinent from alcohol for at least one week, but not more     than 30 days. We compared outcomes for the two study arms by assessing     biochemically-validated point-prevalence smoking status at 3, 6, 9, and 12 months     post-baseline and continuous abstinence over the 12-month follow-up. Expired-air carbon     monoxide (CO) was used to biochemically verify 7-day point prevalence abstinence. We also     conducted an economic analysis to determine the cost-effectiveness of the intensive     intervention compared with usual care. We also examined cross-relapse patterns during the     follow-up period, assessing changes in mood states and use of tobacco, alcohol, and other     drugs at 3, 6, 9, and 12 months.   "
181488|NCT00217997|"     Cocaine dependence is a major public health problem; an effective primary treatment for     cocaine dependent individuals has yet to be found. The purpose of this trial is to evaluate     aspects of treatment response in cocaine dependent individuals.   "
181489|NCT00218010|"     Methadone is a drug that offers significant therapeutic benefits to opiate dependent women     who are pregnant. Currently, it is the treatment of choice for this group of people. The     purpose of this study is to determine the amount of methadone in the breast milk of women who     are breastfeeding and taking methadone for opiate addiction. In addition, this study will     evaluate the effects of methadone on infant neurobehavior.   "
181490|NCT00218023|"     Cocaine dependence is a major public health problem; an effective primary treatment for     cocaine dependent individuals has yet to be found. The purpose of this study is to identify     subpopulations and baseline conditions that are most responsive to treatment for cocaine     dependent individuals.   "
181491|NCT00218036|"     The purpose of this study is to examine two medications, modafinil and citalopram, in the     treatment of cocaine dependent individuals who are maintained on methadone.   "
181492|NCT00218049|"     Cocaine dependence is a major public health problem; an effective primary treatment for     cocaine dependent individuals has yet to be found. The purpose of this study is to determine     the safety and effects of vanoxerine (GBR 12909) in treating cocaine dependent individuals.   "
181493|NCT00218062|"     Cocaine dependence is a major public health problem; an effective primary treatment for     cocaine dependent individuals has yet to be found. The purpose of this study is to examine     the effects of d-amphetamine and modafinil, when given alone and in combination, in treating     cocaine dependent individuals.   "
181494|NCT00218075|"     Cocaine dependence is a major public health problem; an effective primary treatment for     cocaine dependent individuals has yet to be found. The purpose of this study is to examine     the effectiveness of levodopa and carbidopa in treating cocaine dependent individuals. In     addition, this study will examine the effects of incentive rewards for treatment compliance.   "
181495|NCT00218101|"     Opioids used to treat chronic pain have a high abuse potential. The purpose of this study is     to determine the effectiveness of buprenorphine in treating opioid dependent individuals who     abuse opioids that are prescribed for chronic pain.   "
181496|NCT00218114|"     The purpose of this study is to compare the effectiveness of divalproex sodium (Depakote)     versus placebo in treating disruptive behavior disorder and explosive tempers in adolescents     and adults.   "
181497|NCT00218127|"     Heroin dependence remains a major addiction problem in the United States. The purpose of this     study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin     dependent individuals.   "
181498|NCT00218140|"     Women typically have a more difficult time quitting smoking than men. Little research has     been done to understand the differences between men and women that may cause this     distinction. This study will assess whether the reduced effectiveness of nicotine replacement     therapy in women is caused by gender differences in the withdrawal suppression induced by     nicotine replacement therapy.   "
181499|NCT00218153|"     Naltrexone Augmentation of Nicotine Patch Therapy   "
181500|NCT00218166|"     Cocaine abuse continues to represent a significant public-health concern. Cocaine likely     creates its addictive effects by increasing levels of dopamine, a chemical found in the     brain. GABA agonists are chemicals that have the opposite effect of cocaine by inhibiting the     release of dopamine. The purpose of this study is to determine whether GABA agonists reduce     the psychological and physiological reinforcing effects of cocaine.   "
181501|NCT00218179|"     Lung cancer is the leading cause of cancer death in the United States. Currently it remains     impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a     mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and     metabolism are a useful tool and available to use. The purpose of this study is to assess the     link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.   "
181502|NCT00218192|"     The purpose of this study is to examine the efficacy of a brief motivational intervention on     the cumulative incidence of Hepatitis C.   "
181568|NCT00212368|"     The purpose of this study is to determine whether Zinc Acetate is effective and safe in the     treatment of Wilson's disease among Japanese.   "
181503|NCT00218205|"     The purpose of this clinical trial is to find out the effect of epirubicin with estramustine     phosphate and celecoxib on PSA and objective response in patients with hormone resistant     prostate cancer as well as evaluating the toxicity, quality of life of this combination.     Celecoxib is an FDA approved drug to treat arthritis. Epirubicin, alone or with estramustine     phosphate has been used in the treatment of hormone resistant prostate cancer. These drugs     have demonstrated evidences of tumor blood vessel suppression and combination of these three     drugs could possibly arrest further tumor growth or even make the tumor decrease in size.   "
181504|NCT00218218|"     Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals     without schizophrenia. While a great deal of research has been focused on smoking cessation     programs for healthy individuals, little attention has been directed towards developing an     effective smoking cessation treatment for schizophrenics. This project will evaluate the     effects of 0, 21 and 42 mg transdermal nicotine on smoking, urge to smoke, and nicotine     withdrawal symptoms after 5 hrs abstinence in smokers with schizophrenia and heavy-smoking     non-psychiatric control smokers.   "
181505|NCT00218231|"     Many individuals with schizophrenia smoke cigarettes but little is known about the factors     that control smoking in people with schizophrenia. The purpose of this trial is to evaluate     how bupropion, an antidepressant medication, affects smoking behaviors in individuals with     schizophrenia who smoke.   "
181506|NCT00218244|"     Though spit tobacco is smokeless, it still affects the cardiovascular system and may be     associated with heart disease, stroke, and high blood pressure. This study will assess the     effectiveness of limiting smokeless tobacco (ST) nicotine intake in reducing levels of     exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit     or sustain lower levels of nicotine intake.   "
181507|NCT00218257|"     Past research has demonstrated that cocaine dependent women experience less severe responses     to cocaine during the luteal phase of the menstrual cycle, when estrogen and progesterone     concentrations are high. The purpose of this study is to determine whether administered     progesterone reduces subjective and physiological responses to cocaine in cocaine dependent     individuals.   "
181508|NCT00218270|"     Though spit tobacco is smokeless, it still affects the cardiovascular system and may be     associated with heart disease, stroke, and high blood pressure. Long-term effects of     smokeless tobacco (ST) include tooth abrasion, gum recession, mouth disease, loss of bone in     the jaw, yellowing of teeth, and chronic bad breath. This study will assess the effectiveness     of using tobacco free snuff in reducing levels of exposure to tobacco and associated     toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine     intake.   "
181509|NCT00218283|"     Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has as many health     risks associated with its use as cigarettes. While there are many treatment programs that     focus on stopping tobacco use, there are no interventions that specifically focus on reducing     tobacco use. This study will evaluate the effectiveness of nicotine lozenge at reducing     tobacco use in ST users.   "
181510|NCT00218296|"     Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks     associated with its use. While treatment programs that focus on stopping tobacco use may be     effective, past research has shown that interventions that specifically focus on reducing     tobacco use may be equally effective and may motivate individuals to eventually quit using     tobacco. This study will compare the effectiveness of a ST reduction treatment program versus     a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in     ST users.   "
181511|NCT00218309|"     The purpose of this study is to determine whether the opportunity to take free supplemental     hydromorphone (HYD) influences drug seeking behavior in heroin dependent individuals.   "
181512|NCT00218322|"     Adolescents with attention deficit hyperactivity disorder (ADHD) often develop substance use     disorders (SUD). The purpose of this study is to evaluate the effectiveness of atomoxetine in     treating adolescents dually diagnosed with ADHD and SUD.   "
181513|NCT00218335|"     The purpose of this study is to evaluate a peer-based HIV prevention intervention that     targets active injection drug users and their drug and sex partners.   "
181514|NCT00218348|"     Dextro-amphetamine sulfate is a central nervous system stimulant that increases the release     of the neurotransmitter dopamine in the brain. The purpose of this study is to further     examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence.   "
181515|NCT00218361|"     The purpose of this study is to determine whether knowledge of post-session hydromorphone     (HYD) availability reduces drug seeking behavior in heroin dependent individuals.   "
181516|NCT00218374|"     Individuals who reduce or stop use of opioid medications are at risk for developing     hyperalgesia, which is an increased sensitivity to pain. This study will compare the     effectiveness of dextromethorphan, gabapentin, and oxycodone at reducing hyperalgesia in     individuals addicted to opioids who are concurrently receiving methadone treatment.   "
181517|NCT00218387|"     Cocaine addiction is a serious health problem with no available medical treatment for     preventing relapse. Modafinil, a medication that enhances mood, increases energy, and     improves concentration, may be useful in preventing relapse among individuals with cocaine     addiction. This study will evaluate the effectiveness of modafinil, in combination with     cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.   "
181518|NCT00206323|"     Previous studies using topiramate in Tourette subjects have shown that with the use of this     medication subjects report that their tics get better. The purpose of this study is to study     if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other     associated symptoms such as attention or obsessive-compulsive problems.   "
181519|NCT00206336|"     Previous studies using topiramate in Tourette subjects have shown that with the use of this     medication subjects report that their tics get better. The purpose of this study is to study     if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other     associated symptoms such as attention or obsessive-compulsive problems.   "
181520|NCT00206349|"     The purpose of this study is to learn about the relationship that exists between coping     skills and blood glucose control. In addition to this, we will study the effect of Type 1     diabetes on coping skills in different age groups, genders, ethnicities, socioeconomic     groups, and the duration of diabetes.   "
181523|NCT00206388|"     The purposes of this study are:        1. To find the highest dose of monthly intravenous Zometa that can be given with daily low          doses of cyclophosphamide by mouth to children with recurrent or refractory          neuroblastoma without causing severe side effects.        2. To find out the side effects seen by giving Zometa and cyclophosphamide on this schedule          at different dose levels.        3. To measure blood and urine levels of Zometa during treatment        4. To preliminarily evaluate the antitumor activity of Zometa and concomitant oral          cyclophosphamide in children with recurrent and/or refractory neuroblastoma within the          confines of a Phase I study.        5. To measure the effects of Zometa on markers of bone breakdown found in urine, blood, and          bone marrow        6. To measure the effects of Zometa on the immune system.   "
181524|NCT00206401|"     In this study, we plan to examine the difference in effect on blood glucose control in     patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice     daily, injected separately) or on intensive insulin management (IIM-several shots of short     acting and Glargine insulin). Those on IIM will be mixing the insulin Glargine with the     short-acting insulin analog prior to injecting. The Hemoglobin A1c (HbA1c) results will be     used to monitor blood glucose control over a 6 month period. Twice during the course of the     study, a continuous glucose monitoring system (CGMS-a device the size of a pager that records     blood sugar readings every 5 minutes) will be used to record all the changes in the blood     glucose levels occurring over a 72-hour period.   "
181525|NCT00206414|"     The investigators want to know if combining Arimidex and Faslodex with Iressa will be an     effective treatment for breast cancer. They also want to know, using special tests on the     tumor, the changes that occur with the treatment so they can try to improve their treatment     for breast cancer in the future.   "
181526|NCT00206427|"     We want to learn whether GW572016 is effective in breast cancers that have HER2.   "
181527|NCT00206440|"     This study will look at a drug called esomeprazole, the newest PPI, as a way to further     reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin     or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach     acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they     may be able to enjoy their daily routines much more while they are getting chemotherapy.   "
181528|NCT00206453|"     We, the investigators at Baylor Breast Care Cancer, are doing this study to learn how well     Taxotere makes tumors become smaller. We are also doing this study to find out how well     Taxotere treats the type of breast cancer that some patients have. We are asking patients to     take part in this study because they have locally advanced breast cancer. Women with this     breast cancer will usually receive chemotherapy medicines to reduce or shrink the cancer     before surgery to take out the cancer. If patients choose to take part in this study, they     will receive Taxotere and the combination of cyclophosphamide and doxorubicin. These     medicines are part of the standard good medical care for this type of breast cancer. They are     approved for the treatment of this problem. To help us learn how the patients' cancer     responds to these medicines, we will take a small tissue sample (biopsy) of the patients'     breast cancer before beginning treatment, one day after the first dose of treatment, once     each week for the first three weeks of treatment, and when surgery is done as part of     treatment for their cancer. These samples will be collected also to look at the biology of     the patients' cancer. We will also use a new method called cDNA array technology, which lets     us look at thousands of genes (coding information inside the cancer cell) at once. By looking     at different genes in the breast cancer, we may learn important information about which     cancers will respond to a chemotherapy medicine. We hope to learn if there are different gene     patterns in patients whose tumors shrink or do not shrink with this chemotherapy medicine.     This information may help us, in the future, to choose the right medicines for women with     breast cancer so that they have the highest chance of their cancer shrinking with     chemotherapy medicine. We cannot and do not know if patients will benefit if they take part     in this study.   "
181529|NCT00206466|"     We are asking you to take part in a research study of biomarkers (characteristics or traits     of the genes inside cancer cells). We want to learn if these biomarkers could help us learn     how well your breast cancer may respond (improve) to chemotherapy (drugs to treat cancer).   "
181530|NCT00206492|"     The researchers want to learn whether ZD1839 can improve the activity of tamoxifen, a drug     that participants will receive for the treatment of the type of breast cancer being studied.     Tamoxifen medicine is part of the standard treatment for the type of breast cancer being     studied. It is approved for the treatment of this problem. In order to help the researchers     understand how the cancer responds to these medicines, the researchers will take a small     tissue sample (biopsy) of the breast cancer before beginning treatment and after two weeks of     treatment, at 6 weeks and when surgery is done as part of treatment for the cancer. If     participants do not respond to treatment, another biopsy will be done to see why the     participants did not respond. These samples will also be collected to look at different     characteristics of the cancer. The researchers cannot and do not guarantee that participants     will benefit if they take part in this study   "
181531|NCT00206505|"     The purposes of this study are to better understand how Taxotere causes tumors to become     smaller and to find out how effective Taxotere is in treating the type of breast cancer that     you have.   "
181532|NCT00206518|"     The purpose of this study is to learn if the biomarker information obtained (learned or     received) from the earlier studies can tell us whether or not Taxotere and/or     Adriamycin/Cytoxan can cause tumors to become smaller.   "
181533|NCT00206531|"     While HIV mainly infects mature T-cells it can also infect newly produced (or naïve) T-cells.     These infected naïve T cells may then act a viral reservoir even in patients with     undetectable viral loads. Understanding when and how these cells are infected is important     because it could help us to understand why patients fail therapy even if they have a     persistently undetectable viral load.   "
181569|NCT00218413|"     Nicotine is highly addictive and many individuals are unable to quit smoking even with     treatment. The purpose of this study is to determine the effectiveness of various doses of     NicVAX in treating nicotine dependent individuals.   "
181814|NCT00215670|"     The objectives of this study are to characterize the safety, tolerability and     pharmacokinetics of pegaptanib when given as 1 or 3mg/eye intravitreous injections every 6     weeks for 54 weeks in patients with subfoveal choroidal neovascularization (CNV) secondary to     AMD.   "
181572|NCT00218452|"     The purpose of this study is develop and test the success of a new smoking cessation     intervention that includes a component to eliminate binge drinking.   "
181614|NCT00221819|"     To humidify gases during non invasive ventilation, both to heated humidifier (HH) and heat     and moisture exchanger (HME) are routinely used. Patients receiving non invasive ventilation     for acute respiratory failure were randomized to HME or HH. The purpose of this study was to     evaluate respiratory parameters and arterial blood gases (ABG) of patients during NIV with     small dead space HME compared to HH.   "
181615|NCT00221832|"     The aim of this study is the identification of familial congenital arrhythmogenic disorders     and their clinical follow-up.   "
181534|NCT00206544|"     OBJECTIVE:      To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind,     placebo-controlled study in the treatment of acute mania/hypomania.      HYPOTHESIS:      That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and     more substantial decrease in manic symptoms over the course of the study than women receiving     adjunctive placebo.      STUDY POPULATION:      Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective     disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and     Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association.      STUDY MEDICATION:      Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen     at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to     maintain blinding of treatment arm.      Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral     Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain     capsule identical to that used with Tamoxifen.      Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo     (inert substance). The placebo substance will be administered within a plain capsule     identical to that used with Tamoxifen and Progesterone.      STUDY EVALUATIONS:      Data will be collected over a 28-day period for each patient. Visits will be performed at     baseline, and then at weekly intervals. A total of five visits will be completed for each     patient. The following evaluations will be performed:        -  Psychiatric evaluation to determine diagnosis. (Baseline visit only)        -  General clinical evaluation including medical history, current conditions and a          non-invasive physical examination, body weight, vital signs. (Baseline visit only)        -  Medication history (baseline and evaluation visits).        -  Demographics (baseline visits only).        -  Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale          (BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle          Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint          (day 28) visit.        -  Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH),          follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin,          dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and          evaluation visits).        -  Inclusion/exclusion checklist (baseline visit only).        -  Informed consent (baseline visit only).   "
181535|NCT00206557|"     The aim of the project is to investigate the use of raloxifene (a new form of estrogen) as a     treatment for schizophrenia in postmenopausal women. Raloxifene is a selective estrogen     receptor modulator (SERM) which means that it can affect the central nervous system effects     of estrogen (eg: improving emotional symptoms, memory, information processing and     concentration), without adversely affecting reproductive tissue / organs such as breast,     uterus and ovaries.We are conducting a double blind placebo controlled 3 month duration study     comparing the psychotic symptom response between three groups of postmenopausal women with     schizophrenia. One group will receive standard antipsychotic medication plus 60mg Raloxifene,     the second group receives standard antipsychotic medication plus Hormone Therapy(estradiol     2mg oral per day + dyhydroprogesterone 10mg oral per day) and the third group receives     standard antipsychotic medication plus oral placebo. Hypothesis 1: That the women receiving     adjunctive raloxifene or HT would have a quicker recovery from psychotic symptoms, as     measured on the rating scales, compared with the women receiving adjunctive     placebo.Hypothesis 2: That the Raloxifene group would have better cognitive improvement than     the other two groups.   "
181536|NCT00206570|"     To investigate the 'estrogen-protection' hypothesis by comparing changes in psychotic     symptoms between one group of patients receiving standard antipsychotic drug treatment plus     placebo and a second matched group receiving standard antipsychotic drug treatment plus     100microgram estradiol patch in a double blind controlled trial.      Hypothesis : That the women receiving adjunctive estradiol will demonstrate a more rapid and     more substantial decrease in psychotic symptoms over the course of the study than the women     receiving adjunctive placebo.   "
181537|NCT00206583|"     The purpose of this study is to determine whether the study drug is safe and effective in the     prevention of pregnancies in a large group of volunteers.   "
181538|NCT00206596|"     The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need     for steroid treatment for Crohn's disease.   "
181539|NCT00206609|"     The purpose of this study is to determine the effect that oxygen has when administered to     patients complaining of shortness of breath, where the underlying cause of this symptom is     advanced cancer. The study tests the hypothesis that oxygen improves shortness of breath more     than air in this population. Both oxygen and air will be administered to patients in random     order and in a blinded fashion, with patients asked to rate their shortness of breath before     and after each gas. Finally patients will be asked which gas they prefer.   "
181540|NCT00206622|"     To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2     (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot     flushes in postmenopausal women   "
181541|NCT00206635|"     The purpose of this follow-up study is to look carefully at the long-term course of multiple     sclerosis (MS) and possibly the long-term effects of Betaseron in the patients who were     previously enrolled in the original North American study that led to the marketing approval     of Betaseron.   "
181542|NCT00206648|"     The purpose of this study is to determine the difference in preventing a relapse between     Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized     into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be     converted to Betaseron standard dose.   "
181543|NCT00206661|"     The purpose of this study is to observe pediatric Crohn's Disease response to sargramostim in     patients with or without steroid therapy at two possible dosage levels.   "
181544|NCT00206674|"     The purpose of this study is to evaluate if Leukine can induce clinical response or remission     in patients with Crohn's disease.   "
181545|NCT00206687|"     The purpose of the study is to explore the safety, tolerability and efficacy of Spheramine     (cultured human retinal pigment epithelial cells on microcarriers) in Parkinson's Disease     patients with advanced disease who have insufficient symptom control by optimum oral     medication. Patients are randomized to receive Spheramine injections into both hemispheres or     a sham surgical procedure in a ratio of 1:1. A three month pretreatment period must be     completed prior to surgery. Time to endpoint is 24 months.   "
181546|NCT00206700|"     The purpose of this study is to establish a safety profile sargramostim administered in 8     week cycles to adult patients with active Crohn's disease.   "
181547|NCT00206713|"     The purpose of this study is to evaluate whether treatment with Leukine in patients with     Crohn's disease who have previously responded to Leukine can be helped again, once they have     relapsed.   "
181570|NCT00218426|"     Heroin addiction is a growing problem in Russia; individuals who enter heroin addiction     treatment often relapse. Therefore, effective heroin addiction treatments are necessary to     prevent relapse. The purpose of this study is to compare oral naltrexone with a naltrexone     implant that provides opioid blockade for two months in preventing relapse to heroin     addiction in St. Petersburg, Russia.   "
181999|NCT00227955|"     This study will evaluate the effectiveness of five combinations of drug therapy and     psychotherapy in maintaining remission of depression symptoms in people with recurrent major     depression.   "
181548|NCT00206726|"     This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of     alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL)     patients who have received at least one prior therapy.      Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during     Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of     each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and     at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission     (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients     demonstrating presumptive signs of a Complete Remission (CR) will receive no further     treatment but will be followed for response.   "
181549|NCT00206739|"     The purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment     in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks,     episodes of anemia, and the overall morbidity and mortality   "
181550|NCT00206752|"     The purpose of this study is to assess the feasibility of avoiding opposite side neck     radiation therapy in patients with clearly one side squamous cell cancer of the head and     neck. We aim to assess the reduction in treatment volume (amount of radiation therapy     required), and the resultant xerostomia and mucositis, with the delivery of unilateral neck     radiation therapy.   "
181551|NCT00206765|"     We are comparing the efficacy of Risperidone versus Paroxetine in the treatment of panic     symptoms. The study hypothesis is that Risperidone will be a superior medicine for treating     panic.   "
181552|NCT00212160|"     The purpose of this research is to determine some of the reasons that blood sugar and insulin     levels improve after bariatric surgery but before weight loss begins, as well as why people     respond differently to weight loss surgery. It will also examine whether removing the fat     around the stomach and large intestine (the omentum) will improve weight loss. Finally, it     will see why there are differences between Whites and African Americans who have weight loss     surgery.   "
181553|NCT00212173|"     Protocol #1:The goals of this study was to examine whether increased weight loss in obese     adolescent is induced when the weight loss medication sibutramine is added to a family-based,     behavioral weight control program.      Protocol #2: This study aims to improve the behavioral treatment of obesity during     adolescence. A behavioral program using regular foods will be compared to a behavioral     program using a structured meal plan (a portion-controlled approach with liquid-meal     replacements [nutritional supplements]). This structured approach may be better for the     promotion of weight loss compared to a diet of regular foods.   "
181554|NCT00212186|"     The purpose of this study is to determine whether patients with liver disease can improve     their nutritional selenium status by taking supplemental selenium.   "
181555|NCT00212199|"     The purpose of this study is to test the effectiveness of three different methods for     delivering weight management information. Two methods utilize an obesity drug and the third     method utilizes brief behavioral counseling sessions only.   "
181556|NCT00212212|"     This study is being conducted to determine if patients with cirrhosis (liver disease) are     selenium deficient. The effect of supplementation with two chemical forms of selenium on     plasma selenium biomarkers will be determined and correlated with the severity of the liver     disease.   "
181557|NCT00212225|"     Helicobacter pylori (Hp) is a major cause of chronic-active gastritis and primary duodenal     ulcers, and is strongly linked to gastric cancer. Most Hp infections worldwide are acquired     in childhood. Why some individuals develop symptomatic disease is unclear and, until     recently, no studies critically evaluated the role of pediatric Hp strains and/or host     factors in disease outcomes. Over the past 5 years of National Institutes of Health (NIH)     funding, 486 children from Atlanta, Cleveland, and Miami were enrolled; 184 (38%) were     Hp-infected. Race (African American) and younger age, in conjunction with Hp strains     expressing cagA and vacAs1B, were shown to be risk factors for both esophageal and gastric     disease, suggesting a different disease paradigm from Hp-infected adults. Using the updated     Sydney system, the investigators demonstrated a histopathologic spectrum in children, which     included novel observations of atrophic gastritis with intestinal metaplasia.      Overall hypothesis for competitive renewal: disease manifestations in Hp-infected children     are influenced by specific host factors (i.e., race, immune phenotype), environmental     exposures, and specific virulence factors of infecting Hp strains.      Specific aims:        1. Using well defined cases and controls, further characterize specific host factors and          environmental exposures contributing to symptomatic childhood infection emphasizing          targeted enrollment in specific age, gender and demographic strata to facilitate          detection of significant differences not attained previously and follow-up of 2          established specific cohorts to ascertain immune response natural history.        2. Utilize gene-array technology for the whole Hp genome assessment and bacterial gene          expression of specific virulence determinants associated with pediatric Hp strains.        3. Further characterize the host immunologic and mucosal response in Hp-infected children.      Hp-infected symptomatic endoscopy cases at the investigators' established 3 clinical centers     of high, moderate and low Hp prevalence will be compared with age-matched Hp-infected     asymptomatic and uninfected symptomatic controls. Two geographically and demographically     distinct centers have been added to provide additional geographic and subject     representativeness to the patient cohort. The updated Sydney system will be employed to     assess gastric histopathology severity and phenotype in newly enrolled cases in specific age,     gender and demographic strata and follow-up of the two novel cohorts established in the     past 5 years: a) atrophic gastritis; and b) esophageal and gastric disease groups enabling a     comprehensive, multivariate evaluation of the natural history of Hp-infected children in two     distinct disease paradigms.      Using molecular methods (multiplex [MP]-PCR, RT-PCR) and a micro ELISPOT assay on peripheral     blood mononuclear cells (PBMCS), Th1, Th2, Th3 or balanced Th1/Th2 response will be     determined to further characterize the Hp-infected child's immune response phenotype. The     investigators propose to further their previous work with critically lacking studies from a     multivariate approach, leading to a better understanding of the gastroduodenal disease     sequelae and overall pathobiology of Hp infection in humans.   "
181558|NCT00212238|"     The purpose of this study is to compare two Internet-based behavioral weight loss programs.   "
181559|NCT00212251|"     The purpose of this study is to evaluate, in a five-year randomized controlled trial, the     efficacy of an intervention (AMP - ACTIVE MOTHERS POSTPARTUM) to increase physical activity     and promote a healthy diet (decreased calorie and fat intake) for weight loss among     postpartum women who were overweight or obese prior to pregnancy. The hypothesis is that the     proportion of women losing at least 10% of BMI from baseline to 12 months post-intervention     will be significantly greater in the AMP intervention arm than in the minimal care arm.   "
181560|NCT00212264|"     The primary purpose of this study is to test the effectiveness, impact on quality of life,     and durability of non-surgical therapies for incontinence persisting at least one year after     surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week,     multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring     with bladder diaries, regular office visits, bladder control techniques, and fluid     management) to the same program with the addition of biofeedback and pelvic muscle electrical     stimulation.   "
181561|NCT00212277|"     The purpose of this long-term study is to determine whether combination oral contraceptive     pill of Norethindrone & Ethinyl estradiol is effective in the treatmentof dysmenorrhea     associated with endometriosis.   "
181562|NCT00212290|"     The purpose of this study is to examine the effects of treating insulin resistance on memory     and attention, brain glucose utilization, and proteins in spinal fluid.   "
181563|NCT00212303|"     The coexistence of diabetes and hypertension is damaging to cardiac and peripheral vascular     structure and function. Although several health organizations endorse exercise training as a     treatment for type 2 diabetes, most studies of exercise and diabetes have focused on     controlling blood sugar but not on cardiovascular health. The aim of this study is to     determine if exercise training reduces blood pressure and improves cardiovascular health in     persons who have both type 2 diabetes and hypertension. An equal number of men and women will     be enrolled, and another aim of the study is to examine gender differences in response to     exercise training.   "
181564|NCT00212316|"     The purpose of this study is to evaluate the safety, tolerability and clinical impact of     15-grams daily of sodium phenylbutyrate (phenylbutyrate) in Huntington's disease and to lay     the groundwork for possible subsequent trials designed to specifically address its ability to     slow or halt the progression of the disease.   "
181565|NCT00212329|"     Type 1 diabetes is a condition that is caused in part by an abnormality of the immune system     which occurs when T cells, which are part of the immune system, damage the insulin secreting     cells (islet cells) in the pancreas. Although it is known that T cells are important     mediators of the disease, progress in the development of reliable T cell assays has been     modest. The purpose of this study is to learn which T cell assays are most reliable and     reproducible so that the investigators can improve their understanding about how type 1     diabetes occurs.   "
181573|NCT00218465|"     The purpose of this study is to evaluate the efficacy of the glycine antagonist, GW468816,     compared with placebo on duration of abstinence and rates of relapse in recently quit female     smokers in a randomized, double-blind, five-week clinical trial.      According to the investigators, the new medication, GW468816, is thought to send certain     signals in the brain that may be effective in helping people stay abstinent after they have     recently quit smoking. GW468816 is a non-nicotine drug.      The investigators of this study hypothesize that subjects receiving GW468816 will demonstrate     a significantly longer time to relapse to smoking than those in the placebo group, as     measured by the primary outcome measure (see below).   "
181574|NCT00218478|"     The majority of past research on marijuana treatment has specifically targeted the     alleviation of withdrawal symptoms. Minimal focus has been placed on how altering craving     effects may play a role in treating marijuana addiction. The purpose of this study is to     compare the effects of marijuana-related cues versus non marijuana-related cues in     individuals both addicted and not addicted to marijuana. In turn, this may help establish a     better understanding of the effects of marijuana cravings and may lead to improved treatments     for marijuana dependence.   "
181575|NCT00218491|"     Currently, no effective drug treatment exists for cocaine dependence. Glutamate levels are     disrupted with long-term cocaine use. N-acetyl cysteine (NAC) is a drug that is metabolized     by the body to form cysteine, an active compound that normalizes glutamate levels. The     purpose of this study is to determine the safety and effectiveness of NAC in treating cocaine     dependent individuals.   "
181576|NCT00218504|"     The majority of past research on marijuana treatment has targeted the alleviation of     withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a     role in treating marijuana addiction. Treatment with tetrahydrocannabinol (THC), the main     ingredient in marijuana responsible for its reinforcing effects, may decrease marijuana     cravings. The purpose of this study is to evaluate the effect of THC pre-treatment on     responses to marijuana-related cues versus non marijuana-related cues in individuals addicted     to marijuana.   "
181577|NCT00218517|"     During the past 15 years, the demand for treatment for marijuana-related problems in the     United States has increased nearly twofold. Selegiline is a medication currently used to     treat nicotine dependence. The purpose of this study is to evaluate whether selegiline may be     useful in treating individuals with marijuana dependence.   "
181578|NCT00218530|"     Stress is one of the more common reasons cited by addicts for continual drug use and relapse.     Treatment approaches that target both drug-induced and stress-induced relapse may prove to be     more beneficial than targeting drug-induced relapse alone. Lofexidine is a drug that reduces     the physical symptoms of opiate withdrawal and may prove to have stress-reducing capabilites     in drug addicts. The purpose of this study is to determine the maximal safe dose of     lofexidine tolerated in naltrexone-treated heroin addicts and to find an optimal lofexidine     induction schedule.   "
181579|NCT00218543|"     Studies have shown that individuals with attention deficit hyperactivity disorder (ADHD) are     at greater risk for having a substance use disorder compared to people who do not have ADHD.     Rates of cocaine abuse in adults with ADHD are significantly higher than they are in adults     who do not have ADHD. Some clinicians suggest that adults with ADHD may abuse cocaine in     order to self-medicate their ADHD symptoms. Atomoxetine is a drug that has been effective in     treating ADHD. This study will evaluate the effectiveness of atomoxetine in reducing cocaine     use in people with ADHD who abuse cocaine.   "
181580|NCT00218556|"     The purpose of this study is develop and test a cognitive-behavioral intervention to prevent     depression in methadone maintenance patients receiving medical treatment for hepatitis C.   "
181581|NCT00218569|"     The purpose of this study is to examine whether Naltrexone and cognitive behavioral therapy     can be helpful in patients who want to stop using cocaine and alcohol.   "
181582|NCT00218582|"     The purpose of this study is to determine the effectiveness of adding dual focus 12-step     self-help groups to standard treatment to improve behavioral outcomes for patients dually     diagnosed with substance abuse and psychiatric disorders.   "
181583|NCT00218595|"     The purpose of this study is to examine the efficacy of DBT compared to a standard drug     counseling approach for the treatment of opiate addiction and borderline personality disorder     (BPD). Treatment research has repeatedly shown that retention of BPD and substance addicted     individuals to be the among the most challenging for therapists. DBT has established itself     as one of the most effective treatments for treatment retention of these patients and for     reducing parasuicidal and self-injurious behaviors.      This study is one of two in a multi-site RCT for the treatment of opiate addiction. DBT has     been shown to be efficacious for the treatment of BPD patients and it has been extended in     this study to target addictive behaviors in these patients. The study consists of three     treatment parts: weekly individual and group therapy and suboxone maintenance medication.     Participants are provided therapy on a weekly basis for one year and suboxone for 2 years.     Assessments for tracking outcome are conducted every 4 months.      It is hypothesized patients in the DBT condition will show a reduction of substance use,     parasuicidal and other psychological difficulties and these gains will be maintained through     the year of follow-up assessments. In addition, it is predicted that adherence to DBT     treatment protocols will be associated with improved outcomes. Finally, it is predicted that     treatment dosage (average hours of therapy/week) will be positively related to clinical     improvement.   "
181600|NCT00221637|"     The purpose of this study is to determine whether valproate is effective and well tolerated     in the treatment of neuropathic peripheral pain. The drug is administered by intravenous     route followed by oral route during 4 weeks.   "
182654|NCT00233506|"     -  CpG has the potential to stimulate the immune system        -  this study will evaluate the safety of CpG given sub-q or IV        -  purpose is to measure biological changes in CLL cells after receiving CpG   "
181584|NCT00218608|"     Cocaine is an extremely addictive stimulant drug that directly affects the brain. It is used     in several different forms and can be snorted, smoked, or injected to achieve the desired     effect. Cocaine users are at risk for many health problems, both directly and indirectly     related to the effects of cocaine. Disulfiram, a drug used to treat chronic alcoholism, may     be effective in reducing cocaine use. This study will evaluate the effectiveness of three     different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent     individuals maintained on methadone.   "
181585|NCT00218621|"     The purpose of this study is to evaluate the effects of drugs used by treatment providers on     the fetuses and infants of opiate dependent women. The subjects in this study are women     enrolled in a large, multi-site, double blind study that looks at the effects of methadone     and buprenorphine treatment during pregnancy. This study will evaluate fetal and maternal     biophysiologic data longitudinally during pregnancy to determine how these substances may     affect fetal neurobehavior. Additionally, infant neurobehavioral assessments and measurements     of infant vagal tone will be collected to see how methadone and buprenorphine differentially     affect the neonatal abstinence syndrome, or withdrawal in exposed neonates.   "
181586|NCT00218634|"     Patients with HIV, depression, and opioid-dependence are at high risk for poor health     outcomes. This is a two-arm randomized controlled trial of cognitive-behavioral therapy for     depression and HIV medication adherence in patients with opioid dependence who are receiving     methadone maintenance treatment. The project is based on our pilot work with close attention     to NIDA guidelines for a staged approach to treatment development and testing (Rounsaville et     al., 2001).      Depression is highly comorbid with both HIV infection and with opioid dependence. Depression     and substance abuse are both associated with poor adherence to antiretroviral medications.     Patients with HIV, depression, and opioid dependence are at high risk for poor health     outcomes. Cognitive-behavioral therapy is the most widely studied and efficacious     psychosocial intervention for depression; and research by the PI and others has shown that     cognitive-behavioral interventions have been successful in promoting adherence to HIV     medications.   "
181587|NCT00218660|"     The purpose of this study is to see whether naltrexone is safe and useful in preventing     alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of     alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration     (FDA) for the treatment of alcohol dependence. However, the medication was not approved as     yet at the dosage we will use in this study. The dosage we will use for the study (150 mg),     is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike     other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone     will not make you sick if you drink alcohol. Rather, people who are taking this medication     have reported that it helps decrease the pleasure associated with drinking for them. This     study is being conducted because the medication (Naltrexone) has not been well studied in     people with both alcohol and cocaine dependence, so it is still investigational.      We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy,     this may lead to reduced cocaine use. We are also conducting this study to test two different     types of psychotherapy as a method for reducing cocaine and alcohol use. One type of     psychotherapy, CBT, is designed to help people learn to cope with situations that put them at     high risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy, BRENDA,     will use focuses on strengthening motivation to recover from cocaine and/or alcohol use, and     on developing techniques to handle possible barriers to recovery. We seek to enroll 300     patients in the study.   "
181588|NCT00218673|"     The purpose of this study is to conduct a randomized controlled trial to assess the efficacy     of a peer-educator intervention focused on injection drug users and their drug and sexual     networks. We expect that participants who receive the intervention will demonstrate a     reduction in the rate of HIV infection and HIV risk behaviors and members of their risk     network will also demonstrate reductions in risk behaviors compared to those in the control     group.   "
181589|NCT00218686|"     The purpose of this study is to evaluate a peer-based HIV prevention intervention that     targets active injection drug users and their drug and sex partners in Chennai India.   "
181590|NCT00218699|"     This study will evaluate the effectiveness of a single specialized pre-test counseling     session in reducing HIV infection risk behavior in men who are not HIV infected.   "
181591|NCT00218712|"     This study will evaluate the effectiveness of a specialized cognitive-behavioral counseling     intervention in reducing sexual risk behaviors in men who are HIV-infected and report having     unprotected sex with male partners who are either not HIV-infected or do not know if they are     HIV-infected.   "
181592|NCT00218725|"     This study will examine the effectiveness of combining cognitive therapy with enriched usual     care for preventing subsequent suicide attempts in people with a drug dependence who have     recently attempted suicide.   "
181593|NCT00218751|"     This study will evaluate the effectiveness of Hawaii's Healthy Start Program (HSP), a home     visitation program for families at risk for child abuse, in promoting the health and     development of children.   "
181594|NCT00218777|"     This study will determine the effectiveness of cognitive behavior therapy (CBT) with habit     reversal training (HRT) in treating chronic tic disorders (CTDs) in children and adolescents.   "
181595|NCT00221572|"     Measurement of bone density of Cystic Fibrosis patients with two techniques and correlation     to serum bone parameters, use of steroids, lung function and nutritional status.   "
181596|NCT00221585|"     A prospective, longitudinal, multi-centre investigation (16 centres), including 562 patients,     consecutively referred during two years, with a first-episode psychosis of ICD-10, F-2 type.     Patients were treated with: 1) ‘Supportive psychodynamic psychotherapy as a supplement to     treatment as usual’, 2) an ‘Integrated, assertive, psychosocial and educational treatment     programme’, and 3) ‘Treatment as usual’.   "
181597|NCT00221598|"     Comparison between dialysate temperatures on haemodynamic stability and haemodialysis     efficiency.   "
181598|NCT00221611|"     Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral     palsy patients, by means of standardized and internationally accepted scales   "
181599|NCT00221624|"     Response to a second-line anti-HCV treatment in non responder patients to a first-line dual     therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be     potentially effective to treat hepatitis C.   "
181613|NCT00221806|"     The aim of this project is to improve the hemocompatibility of vascular prosthesis with a     complete covering of its endoluminal surface with autologous endothelial cells. The objective     is to obtain a better bypass permeability with arterial prosthesis replacing low diameter     vessels in lower limbs   "
181707|NCT00223080|"     The purpose of this study is to determine whether immunizations with an integrated     combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in     healthy Thai volunteers.   "
181601|NCT00221650|"     Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C.     Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have     previously been treated with a first line anti-HCV treatment. The purpose of the study is to     evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with     chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin.     The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of     ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained     virological response, defined as an undetectable HCV RNA level 24 weeks after the end of     anti-HCV treatment.   "
181602|NCT00221663|"     Minimally-invasive operative techniques have been introduced in cardiac surgery. These     techniques may have several advantages such as a decrease in post operative pain, lower     morbidity and mortality, faster recovery, and a shorter hospital stay. However, these     advantages have rarely been documented in the setting of a formal randomized controlled     trial.   "
181603|NCT00221676|"     Besides the personal protection, influenza vaccination especially needs to prevent     transmission of influenza between GPs and their patients. The question remains if the vaccine     is adding substantial benefit to the natural acquired immunity of GPs. Doubts are raised if     an inactivated vaccine, which elicit especially humoral immune response, can give enough     protection against virus replication and subclinical influenza infections. Until now no     effectiveness studies of influenza vaccination were performed among GPs. This study will     assess the effectiveness of an inactivated influenza vaccine in GPs against clinical     respiratory tract infections and more particular against influenza cases with influenza     positive nose and throat swabs (diagnosed by RT-PCR).   "
181604|NCT00221689|"     Within the framework of a prospective double-blind and randomized study evaluating the     efficacy of continuous intrathecal baclofen therapy (CIBT) on paroxysmal dysautonomia (main     objective) and hypertonia, recovery and tolerance (secondary objectives) during the initial     recovery phase of severe head injury, continuous intrathecal baclofen infusion will be     delivered. The first week of study is double-blind: the first of two parallel groups receives     CIBT and the second group receives placebo. The main outcome (number of neurovegetative     episodes) is assessed at the end of first week. The second week of study is open labeled:     active treatment is continued in the first group and the second group starts active CIBT     treatment. The third week of study, treatment is stopped in both groups.   "
181605|NCT00221702|"     Melanoma with a tumor thickness >= 1.5mm without clinically detectable nodes represents an     increasing population with relapse rate of more than 50%. Adjuvant therapy with low doses of     IFN alpha can provide a benefit in this group. However, the impact of low dose IFN alpha is     not sustained after the treatment period. A longer treatment may prolong the benefit and thus     have a more clear-cut impact on disease-free and overall survival. The tolerance and the     impact on quality of life are limiting factors in a group of patients whose individual course     is not necessarily poor. PegIntron may be better tolerated than instant release interferon,     and thus make this treatment more acceptable in terms of toxicity and quality of life. Thus     treatment schedule with PegIntron is not expected to increase the cost of standard care     significantly.   "
181606|NCT00221715|"     When medical treatments fail, critical ischemia of the lower limb often leads to surgery,     i.e. above knee femoro popliteal bypass. This bypass can be performed either with DACRON or     PTFE prosthesis or with the autologous saphenous vein. Both technics are used but they have     not been compared regarding bypass permeability and limb salvage. Thus, this study will     compare the permeability rate of above knee femoro popliteal surgery whether performed with     autologous vein versus prosthesis   "
181607|NCT00221728|"     Surgical treatment of multiple or recurrent renal tumors may be complicated by renal function     impairment. Mini-invasive thermotherapy as radiofrequency (RF), induces necrosis of tumoral     tissue while sparing normal renal parenchyma. The purpose of the study is to compare, in     patients at risk of renal insufficiency, a strategy based on surgical approach and a strategy     based on RF approach. 180 patients from 9 centers will be randomized in two groups (surgical     vs. RF, delivered either percutaneously or under laparoscopy). The proportion of patients     with a local carcinologic efficacy at 5 years and the general and renal tolerance will be     analysed and compared between both strategies.   "
181608|NCT00221741|"     Despite experts' recommendations, the consumption of Fresh frozen plasma (FFP) is very     heterogeneous among French cardiac surgery centers. This probably reflects heterogeneous     practices that are not characterized and whose outcomes on morbidity and mortality are not     documented.      The principal objective of the study is to describe transfusional strategies of FFP in     patients undergoing cardiac surgery. The other objectives are: to assess the conformity of     FFP transfusion or lack of transfusion to current French authorities' recommendations, to     describe the post-operative mortality and morbidity and to assess the prognostic role of FFP     on mortality and morbidity. Prognostic analyses will take into account other prognostic     factors of mortality and morbidity.      1500 patients undergoing cardiac surgery and presenting with a serious bleeding (or     transfused with FFP without bleeding) will be included in the study.   "
181609|NCT00221754|"     To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with     protease inhibitors in a randomised double blind study.   "
181610|NCT00221767|"     Bladder dysfunction is a major problem in patients with complete spinal cord lesions. For     patients presenting incontinence or risk for kidney, two major conventional alternatives are     possible : conservative therapies (muscarinic receptor antagonists, vanilloids drugs and     botulinum toxin in association with catheterization) and surgical techniques intervening in     the nervous and urinary system.      Among these last alternatives, the Brindley technique (anterior sacral root stimulation with     posterior rhizotomy) is the only technique allowing for the restauration of bladder function,     continence, and micturition. The purpose of the study is to compare the Brindley technique     with the first conventional approach in France from a medical and economical point of view.   "
181611|NCT00221780|"     Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and     mortality in heart failure patients. However, very few is known about the importance of the     left ventricular pacing site. We study in a random order 11 different left ventricular pacing     sites and compare their hemodynamics using pressure-volume catheters. The consequences on the     surface ECG are also assessed.   "
181616|NCT00221845|"     In children with chronic kidney disease, progression to end-stage renal failure is associated     with high patient morbidity and poor quality of life. In adults, inhibition of the renin     angiotensin system (RAS) slows down the rate of renal failure progression. This concept is as     yet unproven in children, in whom chronic renal failure (CRF) is more commonly due to     hypo/dysplastic malformations than to acquired glomerulopathies as typical for adult chronic     kidney disease. The current project aims at assessing the genetic and molecular mechanisms     and cardiovascular consequences of progressive CRF and to develop a strategy of     pharmacological renoprotection in children.   "
181617|NCT00221858|"     This is a quality assurance database to prospectively examine regional anesthesia outcomes at     Toronto Western Hospital.   "
181618|NCT00221871|"     Ketamine added to Lidocaine can increase duration of pain relief following intraveonous     regional anesthesia (IVRA). The purpose of this dose response study is to determine the     minimum effective dosage of intravenous Ketamine, added to 3 mg/kg of Lidocaine. We     anticipate that one dosage will provide us with the proper balance between sufficient     anesthesia and minimal side effects.   "
181619|NCT00221884|"     Many patients undergoing surgery on their hand receive a form of anesthetic called axillary     brachial plexus block. This involves the injection of local anesthetic (freezing medication)     around the nerves that supply the upper limb, which are located in the arm pit. The technique     currently used by physicians performing this procedure is far from perfect, and in up to 1 of     every 5 patients it does not work well enough to allow surgery, and a different form of     anesthetic may need to be used.      In an attempt to improve these results, we have recently developed a new technique, using     ultrasound imaging to see the nerves prior to giving the injection. Our initial results are     very promising, implying that this may be a highly successful and safe approach. The purpose     of this study is to determine if this technique is indeed more successful. In order to do     that, we will ask 110 patients for their participation. They will be divided in two groups,     at random. One group will receive the standard technique (transarterial, using a small needle     to find the artery that is close to the nerves). The other group will receive the injection     after identifying the nerves with ultrasound imaging. They will all receive the same type of     medication, and they will be tested every 5 minutes for half an hour to determine if the     block has been successful, according to pre-established criteria. Their pain control will be     assessed after the surgery and they will be called 24 hours and 1 week after the surgery to     assess their recovery and rule out any possible complications.   "
181620|NCT00221897|"     A prospective, longitudinal observational cohort study evaluating the relationship between     changes in the structure of the eye and the vision loss caused by glaucoma. There are two     main parts to the study: 1) Visual Function and 2) Optic Nerve Structure   "
181621|NCT00221910|"     Nerve freezing injections of the leg are very useful in providing anesthesia and pain     relief for knee and ankle surgery. However, current nerve freezing techniques are blind.     As a result, they are not always successful and may cause complications, albeit infrequent.      The objective of the current study is to determine any advantage in performing these     freezing injections under direct ultrasound guidance, to visualize the nerves. We feel     that by developing this technique, it will allow us to perform these procedures with greater     success and fewer complications.   "
181622|NCT00221923|"     According to the National Eye Institute, Glaucoma affects about three million Americans.     Among Blacks in the United States, open- angle glaucoma is the leading cause of irreversible     visual loss. Glaucoma is four times more likely to develop in Blacks than in Whites.      This is a prospective longitudinal, multi- site observational cohort study designed to obtain     visual function and optic nerve structure data on eyes of Black and White Americans. The     investigators will evaluate the relationship between changes in the structure of the eye and     the vision loss caused by glaucoma.This is the first study where both populations are matched     for quality of care and equal access to care.   "
181623|NCT00221936|"     Patient Centered Care (PCC) is an approach that consciously adopts the patient's     perspective...about what matters (Gerteis, Edgeman, Levitan, Walker, Stokes, Cleary,     Delbanco, 1993). Experiencing pain is the most common concern of patients before surgery -     even ahead of whether the surgery would improve their condition (Apfelbaum, 2003). Current     standard of practice for post-operative pain management in most acute care hospitals today is     intravenous patient controlled analgesia (IV PCA). However, despite the fact that patients     prefer IV PCA because it affords them greater control and provides them with better pain     relief (Ballantyne, Carr, deFerranti, Suarez, Lau, Chalmers, Angelillo, Mosteller, 1998 ;     Rawal, 2001), hospitals routinely take control of pain medications away from patients once     they are switched to pain tablets. Patients must then wait, in pain, for their nurse to bring     them pain tablets.      Patient controlled oral analgesia (PCOA) has been utilitzed in several centers in the US and     Germany. Preliminary evidence from the literature seems to indicate that the benefits of PCOA     are similar to IV PCA including increased patient satisfaction and better pain control     (Striebel, Romer, Kopf, Schwagmeier ,1996; Striebel, Scheitza, Philippi, Behrens, Toussaint,     1998). At the Toronto Western Hospital, University Health Network, we have successfully     implemented a PCOA program on two surgical units (Orthopedics/Rheumatology and Spinal). The     purpose of this study is to compare usual nurse administered oral analgesia to PCOA with     respect to pain, patient satisfaction, and passive range of knee motion in postoperative     total knee replacement patients.   "
182767|NCT00235014|"     The BENEDICT study is conducted to examine the effects of an ACE inhibitor, calcium channel     blockade, a combination of these, and placebo, in the prevention of micro- and     macro-albuminuria in Type 2 diabetic patients.   "
181639|NCT00222144|"     The primary goal of this study is to determine the effects of the combination of Gleevec and     Taxotere in lung cancer in terms of control and reduction of the cancer size. The study will     also test lung cancer to see if the presence of certain protein called receptor for platelet     derived growth factor can influence the effect of the treatment.   "
181640|NCT00222170|"     The purpose of this study is to determine the production of mucin in GERD/RE subjects before     and after 8 weeks of treatment with rabeprazole.   "
181641|NCT00222183|"     This trial evaluates the therapeutic effect of Elidel (pimecrolimus) in comparison to the     corresponding vehicle in patients with chronic discoid lupus erythematosus (dLE) or subacute     cutaneous lupus erythematosus (scLE).   "
181624|NCT00221949|"     Peripheral nerve blocks of the limbs are very useful in providing anesthesia and pain relief     for orthopedic procedures in the limbs (elbows, arms, knees, and legs). Considering that     current nerve block techniques involve locating the main nerves at the top of the limb and     freezing those neural structures in order to provide pain relief to the rest of the     extremity, a comprehensive study of the nerves located lower in the limbs is needed. This     study provides a step in the direction of the development of techniques for advanced nerve     blockade that target nerve structures lower in the limbs to provide precise pain relief     rather than widespread numbness.      The objective of the study aims to use direct ultrasound guidance to develop a comprehensive     examination and identification of the peripheral nerves in the lower region of the upper and     lower limbs (arms and legs). In a sense, this process allows us to visualize the nerves. In     the future, with the experience of visualizing these nerves with the ultrasound machine, we     can develop techniques that may allow us to perform anesthetic blockade with greater success     and fewer complications.      An ultrasound exam will be performed on 8 healthy volunteers to view the peripheral nerves in     the lower arm in three locations: the elbow area, the wrist area, and the midpoint of the arm     between the elbow and the wrist. A set of 8 healthy patients will be given an ultrasound exam     to view the peripheral nerves located in the lower leg by imaging three locations: the knee     area, the ankle area, and the midpoint of the leg between the knee and the ankle. The     appropriate nerves will be identified by ultrasound and images will be captured and recorded     for further corroboration. The group of 16 subjects will allow for varied observations of     anatomical positions of neural and vascular structures, while keeping the sample size fairly     small. No injections will be made at any time during this study.   "
181625|NCT00221962|"     To look at the cognitive effects of abilify in children with a primary diagnosis of Attention     Deficit Hyperactivity Disorder. To examine the safety, effectiveness and tolerability of     abilify in children with a primary diagnosis of Attention Deficit Hyperactivity Disorder.   "
181626|NCT00221975|"     Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and     females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar     disorder (type I or II) and who have met the criteria for substance abuse or dependence of     cocaine, marijuana and/or alcohol within the past six months. Patients begin treatment with a     combination of lithium and divalproex. Once these medications are tolerated, they are     randomly assigned to double-blind treatment with lamotrigine or placebo. Patients remain in     this study until they experience a marked bimodal response for four consecutive weeks. This     study is sponsored by the Stanley Foundation.   "
181627|NCT00221988|"     Epilepsy is a common disorder with an incidence of about 6 per 1000. The incidence     progressively increases above age 50. By age 75, the incidence is two to three fold compared     with any age group. Unfortunately, older individuals are especially at risk to incur     significant side effects to anti-epileptic drugs. A newer anti-epileptic drug may markedly     improve seizure management in older individuals as it is removed by the kidneys and not the     liver and does not interact with other medications. We expect it to be tolerated well in     terms of effects on memory, thinking,balance, and walking. The current study assesses the     side effects of levetiracetam in healthy volunteers aged 65 to 80. Use of healthy volunteers     eliminates the effects of seizures on the outcome.   "
181628|NCT00222001|"     The advance of communication technology has changed medical practice. The concept of medical     telemedicine centers receiving, assessing and managing calls from patients or their carers on     a 24 hour, 7 days a week basis is spreading in the US as well as in European countries.     Usually specially trained nurses using dedicated decision support software provide the     service. One aspect is the so-called triage, i.e. the decision on urgency and optimal     treatment path of a stated medical problem, which has the potential to contain overall     treatment costs.      Despite proliferation of these services, little is known about the quality of the services     provided.      In October 2000 the first 24-hour medical telemedicine centre staffed by medical doctors     started operating in Switzerland. The aims of this study are to assess the quality of service     provided by doctors using decision support software and to determine potential predictors of     incorrect triage.   "
181629|NCT00222014|"     The main end point of the study is to assess survival in cirrhotic patients with refractory     ascites treated by TIPS (using PTFE covered stents) vs patients treated by paracentesis +     albumin infusion.   "
181630|NCT00222027|"     Several prognostic predictors, including baseline ALL features and response to initial     therapy, have been described in adult ALL raising the issue of whether these predictors might     be redundant and which must be considered for treatment stratification. In the GRAALL-2003     prospective Phase 2 study, we aim to hierarchize the following high-risk factors in     Ph-negative ALL patients.   "
181631|NCT00222040|"     To determine whether transcranial 2-MHz ultrasound combined with intravenous administration     of microbubbles improves early recanalization in patients with acute ischemic stroke caused     by middle cerebral artery (MCA) proximal occlusion treated with intravenous alteplase within     3 hours of symptom onset.   "
181632|NCT00222053|"     Principal objective is to evaluate the impact of Thalidomide to prolong the duration of     response after autologous transplantation for myeloma   "
181633|NCT00222066|"     The purpose of this study is to determine whether prenatal ovarian cyst aspiration is     effective and safe to prevent perinatal ovarian torsion.   "
181634|NCT00222079|"     The purpose of this research study is to measure acid reflux into the throat both before and     after medical treatment in people who have had radiation therapy to their head and neck for     the treatment of cancer. Many people who have received head and neck radiation therapy     develop a dry mouth as a result of the radiation damage to their saliva glands. In addition     to the discomfort associated with a dry mouth, the decrease in saliva may increase the     severity of gastro-esophageal reflux disease (acid reflux). Acid reflux occurs when acid     escapes from your stomach into your throat. You may not have any symptoms of acid reflux, but     often it can cause symptoms of heartburn or chest discomfort.      Acid reflux can be treated once it is diagnosed. Treatment consists of dietary changes,     behavioral alterations, and medication. Medications are available that decrease the amount of     acid in your stomach. Diagnosis of acid reflux is made with a pH-probe to test for acid in     your throat.   "
181635|NCT00222092|"     Octreotide, somatostatin and pentoxyfilline commercially available drugs that are used in     various clinical situations. They are safe and known for years. Octreotide and somatostatin     have been used in many studies for the prophylaxis and treatment of pancreatitis and     post-ERCP pancreatitis, while pentoxyfilline has shown effect on patients with alcoholic     hepatitis, obstructive vasculitis etc. The aim of the study is to evaluate the efficacy of     any of those treatments for the prophylaxis and treatment of post-ERCP pancreatitis. In     addition some molecular markers of acute and chronic inflammation will be measured before and     after the endoscopic procedures according to the study protocol.   "
181636|NCT00222105|"     Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone     for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and     autologous stem cell transplant.   "
181642|NCT00222196|"     Background: Percutaneous transluminal angioplasty (PTA) has been popularized as a simple,     effective and cheap treatment achieving 50-70% symptomatic patency rates in patients with     peripheral occlusive disease.. However, the fact remains that the indication for performing     PTA are still more based on opinions than on scientific data.      The purpose of the trial was to randomize patients primarily referred for intermittent     claudication into two groups: One group was offered conservative treatment; the other group     was offered conservative treatment combined with PTA.      Primary outcome: The patient quality of life. Secondary outcome:Pain-free walking distance;     pain-score; death; amputation; changes in relevant biomarkers   "
181643|NCT00222209|"     The project investigates on the role of pain avoidance, comorbidity and stress response for     the development of chronic somatic and visceral pain. We, the researchers at University     Hospital Mannheim, assume that implicit operant learning of pain sensitization is a central     mechanism of the process of pain becoming chronic, which is augmented by fear and by     avoidance behaviour. Somatic and psychological comorbidity as well as stress factors are     further promoting factors in chronic pain development.   "
181644|NCT00222222|"     Aims of the study were to find vascular markers of inflammation and endothelial damage during     the course of severe sepsis in septic patients and the effects of treatment with     anti-inflammatory medication (such as Drotregocin alfa (activated)). Another aim is to find     new markers and gene polymorphisms for prognosis and mortality of patients with severe     sepsis. The hypothesis is that higher plasma concentrations of certain markers in septic     patients are associated with a higher mortality rate.   "
181645|NCT00222235|"     This study will determine the effectiveness of treatment with glycine or d-cycloserine in     addition to a normal antipsychotic regimen in improving negative symptoms and cognitive     impairments in patients with schizophrenia.   "
181646|NCT00222248|"     To determine the effect of pelvic floor muscle training in women aged 70 years and over, who     have proven stress urinary incontinence. The hypotheses to be tested are:        1. That pelvic floor muscle training is effective in relief of symptoms of stress urinary          incontinence as measured by a greater reduction in the number of episodes of          incontinence, quantity of urine lost and improvement of quality of life.        2. That women who undertake pelvic floor muscle training will show greater improvement of          pelvic floor muscle function than women who have behavioural (bladder) training, as          measured by real time transabdominal ultrasound.   "
181647|NCT00222261|"     In the ASCET study, 1000 patients with documented coronary heart disease will be randomized     to either continued treatment with aspirin 160 mg/d or change to clopidogrel 75mg/d. Clinical     endpoints will be recorded for at least 2 years and related to the initial aspirin response,     assessed by the PFA-100® method, to investigate whether aspirin non-responders have higher     composite event rate than responders or whether Clopidogrel treatment in patients     non-responsive to aspirin will reduce their risk of future clinical events. The clinical     events are the composite of unstable angina, myocardial infarction, stroke or death.   "
181648|NCT00222274|"     A growing body of evidence suggests that the symptoms of many fibromyalgia syndrome (FMS)     sufferers might be the result of an imbalance in one of the major stress response systems,     the autonomic nervous system. Thus respiratory sinus arrhythmia (RSA) biofeedback, which has     shown promise in other conditions associated with an autonomic nervous system imbalance,     could be effective in FMS. With the aid of sensors and computers, biofeedback involves     modifying and/or learning how to control normally involuntary processes like blood pressure,     heart rate and the autonomic nervous system through relaxation and breathing. The goal of     this study is to test the effectiveness of a 10-session RSA biofeedback treatment for the     symptoms of fibromyalgia. Forty patients receiving the RSA biofeedback treatment will be     compared to 40 patients receiving another form of biofeedback thought to be minimally helpful     (control group). Later, control group patients will also receive the RSA biofeedback     treatment. We will study improvement in symptoms like pain, fatigue, sleep disturbance and     depression in the RSA biofeedback group and compare these improvements to those in the     control group. We will also assess whether these improvements persist over time and what if     any changes in the autonomic nervous system result from the treatment.   "
181649|NCT00222287|"     The purpose of this study is to investigate the effects of a series of Feldenkrais movement     lessons on mobility and balance, particularly for older adults. The investigators hypothesise     that mobility and balance will improve following the classes.   "
181650|NCT00222300|"     Total Hip Replacement (THR) is a common surgical procedure performed in people with hip     osteoarthritis and appears to be effective in relieving pain and improving function. However     significant wasting and weakness of the hip and knee muscles persists post-operatively.     Although relief of pain and improvement of function are important outcomes following THR,     weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes,     public transport and results in persistent gait abnormalities. Since lower limb weakness is     one of the risk factors for falls, it is important that patients undergo a strengthening     program post-operatively. The hypothesis is that lower limb strength and function will be     better in patients who undergo a strengthening program post-operatively than in those who     have usual care.   "
181680|NCT00222729|"     The purpose of this study is to determine if the combination of two new drugs pemetrexed     (Alimta) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and     neck cancer. Currently pemetrexed is approved by the Food and Drug Administration (FDA) for     another type of cancer, mesothelioma, but it is not approved for head and neck cancer.   "
181667|NCT00222534|"     Respiratory failure is a common consequence of chronic obstructive pulmonary disease (COPD).     A concurrent metabolic alkalosis may worsen the respiratory failure, as a higher pH in blood     (and thus in cerebrospinal fluid) results in a weaker respiratory drive. Use of diuretics is     the most common cause of metabolic alkalosis.      When a patient with an acute exacerbation of a respiratory failure is also alkalotic, there     are (at least theoretical) reasons to lower the pH in order to increase the respiratory     drive. Among other alternatives, the drug acetazolamide can be used for this purpose.      In some hospitals there is a tradition for the use of acetazolamide on this indication, but     any evidence for the effect of such a treatment is rather weak.      Thus, the aim of this trial is to evaluate the effect of acetazolamide as an adjuvant     treatment for hospitalized patients with acute exacerbation of respiratory failure in     combination with metabolic alkalosis.   "
181651|NCT00222326|"     Optimal pelvic floor muscle function is known to assist bladder and bowel function and     control, pelvic organ support, as well as other areas of health. It is also known that     problems in some of tehse areas can be a consequence of pelvic surgery. By addressing the     requirements for good bladder and bowel function/control, and organ support in the early     post-surgery phase when tissue repair and scar formation are critical, it is proposed that     there will be a rduction in the longterm prevalence of bladder problems, bowel difficulties     and weakened pelvic floor and abdominal muscles in post-surgery patients. This study is a     randomised controlled trial to compare patients undergoing a physiotherapy-supervised pelvic     floor muscle training and behavioural therapy program with a control group. It is     hypothesised that at the 12 month post-operative follow-up assessment, the treatment group     will demonstrate better outcomes in bladder and bowel function and control, as well as     stronger pelvic floor muscle contractile strength than the control group.   "
181652|NCT00222339|"     Stroke is the leading cause of long-term physical disability in Australia. Currently around     25% of hemiplegic stroke patients discharged from rehabilitation have significantly impaired     use of the affected hand with consequent dependence in dressing, grooming and feeding     themselves. The poor outcome can be attributed in part to a lack of focus by therapists on     the negative signs of stroke (weakness and lack of dexterity) as well as too little time     (around 10 minutes per day) being devoted to retraining of the arm. Presently there is a very     limited evidence base to guide the content of clinical practice. Results from both animal and     human studies suggest that specific post-lesion training can result in substantial     improvement in function. The hypothesis is that task-specific training of the affected upper     limb to subjects in the early period following stroke will result in significantly better     functional outcome than standard intervention.   "
181653|NCT00222352|"     In a randomized, controlled clinical trial, point-of care testing at the bedside using the     cardiac biomarker troponin I in ED patients with possible ACS will be compared to traditional     testing of this assay for myocardial necrosis obtained in the central laboratory. Our     hypothesis: point-of-care testing for troponin I will decrease the time for disposition of     patients with possible ACS in the emergency setting and decrease the time required for     administering appropriate therapies for these patients.   "
181654|NCT00222365|"     This is an add-on, double blind, and randomised clinical trial with three groups: a     homeopathic group, a placebo group, and a temporal control group.      The aim of this trial is to assess the effect of homeopathy on the consumption of morphine     delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.   "
181655|NCT00222378|"     An increase prevalence of CMV, EBV and or HHV-6 in diseased tissue of inflammatory bowel     disease would suggest a role for these viruses in the etiology and/or exacerbation of IBD,     whereas their absence would preclude such association.   "
181656|NCT00222391|"     The purpose of the study is to evaluate the impact of epidural anesthesia on sympathetic     activity in surgical patients. The study investigates whether a segmental sympathetic block     can be determined and can be correlated to level of the sensoric blockade.   "
181657|NCT00222404|"     The purpose of this study is to correlate molecular genetic profile with response to     chemotherapy in case of primary chemotherapy treatment for non-small cells lung carcinoma.   "
181658|NCT00222417|"     We study audiometric parameters including Transient Otoacoustic emissions, pure-tone     audiometry for air- and bone-conduction, and spondaic speech recognition thresholds for air-     and bone conduction in a pre- and postoperative situation in patients due for surgery for     tympanic membrane perforations and otosclerosis. The hypotheses are that the precision of the     preoperative assessment may be increased, and our knowledge about the effect on the inner ear     by middle ear surgery may be increased.   "
181659|NCT00222430|"     The purpose of this study is to compare the use of fluoroscopic guidance, (a commonly used     X-ray technique), with the traditional approach, (where the doctors feel for the strongest     pulse), to obtain access to the blood vessel in the groin. These two methods are being     compared to assess which is faster, safer and more often allows your physician to use an     arterial closure device, a small suture or plug applied at the end of the angiogram where     the needle enters your blood vessel if he/she chooses.   "
181660|NCT00222443|"     Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with     weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles     of this chemotherapy and to estimate the response rate to this combination in children and     adolescents with recurrent solid tumors and lymphomas.   "
181661|NCT00222456|"     The purpose of this study is to examine whether an early intervention program may improve     cognitive and behavioral short and longterm outcome in preterm infants.   "
181662|NCT00222469|"     The purpose of this study is to find out if giving patients bevacizumab along with the     chemotherapy drugs oxaliplatin and gemcitabine will improve overall survival.      In addition, the study will find out what side effects patients may have by taking     bevacizumab, oxaliplatin, and gemcitabine together.   "
181663|NCT00222482|"     This study examines the effect of Depakote ER versus placebo in a randomized trial of     borderline personality disorder. Patients all participate in DBT therapy and those who are     not responsive are assigned to either Depakote ER or placebo for up to 12 weeks. Borderline     Personality Symtoms are measured and side-effects are assessed.   "
181664|NCT00222495|"     The overall goal of this study is to determine the efficacy and tolerability of three     atypical antipsychotic medications (risperidone, olanzapine, and quetiapine) in the treatment     of adolescents with psychosis. It is hypothesized that the three medications will be equally     effective in reducing the symptoms of psychosis.   "
181665|NCT00222508|"     Our general aim is to determine the prevalence of diabetic microvascular complications in     CFRD patients with and without fasting hyperglycemia, and to explore whether the presence of     these complications is related to diabetes or CF factors. This cross-sectional study will     provide pilot data for a longitudinal study of diabetes complications in CF.   "
181666|NCT00222521|"     This Study is designed to determine whether treatment of CFRD with glargine insulin will     improve hemoglobin A1c, weight and muscle mass compared to the traditional regimen of bedtime     NPH insulin.   "
182847|NCT00235872|"     The purpose of the study is to assess the long-term safety and tolerability of repeated     administration of adalimumab in Japanese subjects with rheumatoid arthritis.   "
181669|NCT00222560|"     The Physical Activity Counselling (PAC) randomized controlled trial had as overall goal the     establishment of a collaborative interdisciplinary primary care team to encourage physical     activity. The main intervention was to integrate a physical activity counsellor to the     primary care team so that the most appropriate care was given by the most appropriate     provider. Much research has shown and many experts agree that patients need significant help     to make and especially maintain physical activity behavior changes. Maintenance of these     changes is essential for optimal health benefits. It was predicted that patients receiving     both brief (2-4 minute) physical activity counselling from their family physician and     intensive (3 month) physical activity counselling from an integrated physical activity     counsellor (intensive counselling group) would report greater improvements in task motivation     and task self-efficacy to engage in physical activity at the end of the intervention than     those receiving only brief counselling (brief counselling group). The same was expected for     both self-reported and objective physical activity. This RCT involved testing a theory-based     counselling intervention, determining why the intervention was effective or ineffective by     measuring key psychological mediating variables, using an objective measure to track changes     in physical activity, and assessing physical and metabolic outcomes. This project represents     an innovative theoretically based multi-level multi-intervention approach to promoting     physical activity in primary care and is of great public health importance.   "
181670|NCT00222573|"     COMMIT/CCS2 is a large randomised trial of the effects of clopidogrel plus Aspirin versus     Aspirin alone in acute heart disease. Patients presenting within 24 hours of the onset of     suspected acute MI were potentially eligible provided they were thought to have ST elevation     or other ischaemic ECG abnormality with no clear indication for, or contraindication to,     trial treatment. All patients were to be given 162 mg ASA daily and, in addition, 75 mg     clopidogrel daily or matching placebo for 4 weeks or until prior discharge or death.     (Patients were also randomised separately in a 2 X 2 factorial design between metoprolol     versus placebo.) The two main study endpoints are death and the composite outcome of death,     non-fatal reinfarction or stroke during the scheduled treatment period in hospital.   "
181671|NCT00222612|"     A randomised trial for children with acute lymphoblastic leukemia, using the detection of     minimal residual disease to define risk groups, aiming to answer the questions:        1. Can treatment be reduced without compromising efficacy in a MRD-defined low risk group?        2. Does further post-remission intensification improve outcome for a MRD-defined high risk          group?        3. Measure the Quality of Life impact of the different treatment arms on the children and          their families.   "
181672|NCT00222625|"     Evaluation of efficacy and safety of recombinant factor VIIa versus standard therapy in     preventing early haematoma growth in spontaneous acute intracerebral haemorrhage in patients     treated with oral anticoagulants or antiplatelets agents   "
181673|NCT00222638|"     The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage     variations after Influenza Vaccination   "
181674|NCT00222651|"     To assess the efficacy and safety of Tenecteplase versus Placebo in normotensive patients     with sub-massive Pulmonary Embolism and Right Ventricular Dysfunction (RVD) all receiving     unfractionated heparin (UFH)   "
181675|NCT00222664|"     During 1983-1990 in the Jiangsu province of China, 80,000 infants were randomised by area of     birth between control, standard Hepatitis B vaccination (at 0, 1 and 6 months of age) and     standard vaccination plus a booster dose at about 2 to 3 years of age. The aim is to prevent     establishment of chronic HBV infection in early childhood, hence to prevent the morbidity of     chronic hepatitis B in young adolescents and the incidence/mortality several decades later     from liver cancer and other HBV related chronic liver diseases. Long-term follow-up through     central registries will determine the impact of vaccination on liver cancer incidence and     mortality.   "
181676|NCT00222677|"     To determine whether aspirin is more effective than placebo for the prevention of recurrent     symptomatic venous thromboembolism when given for at least two years after the initial 6-12     month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism   "
181677|NCT00222690|"     The purpose of this study is to conduct semi-structured qualitative interviews to examine the     personal experiences of women living with fibromyalgia. The specific aims of this study are     to identify clinically relevant “triggers” of fibromyalgia symptoms and examine their impact     on activity limitations and participation restrictions.   "
181678|NCT00222703|"     The primary aim of this study is to examine the efficacy of a 12-week nurse-delivered relapse     management intervention designed with conceptual underpinnings from Self-efficacy Theory to     enhance smoking abstinence of hospitalized smokers following their hospital discharge.     Specifically this study asks, does a 12-week Self-efficacy Theory driven relapse management     intervention enhance smoking abstinence following hospitalization by increasing smoking     abstinence point prevalence as measured by carbon monoxide validated self-reports of smoking,     when compared to subjects receiving only enhanced usual care?   "
181679|NCT00222716|"     The primary aim of this study is to compare the effect of an individualized adherence     intervention (TI) and a structured adherence intervention (TS) to usual care on adherence to     antiretroviral therapy in persons infected with HIV (PWHIV).   "
181681|NCT00222742|"     The primary hypothesis for this application for a multicenter phase III randomized clinical     trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 °C) after severe traumatic     brain injury (TBI) in children and maintained for 48 hours will improve mortality at 3 months     and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).   "
181682|NCT00222755|"     The purpose of this research study is to learn whether or not a coordinated medical and     psychiatric care program can improve outcomes of care for patients with bipolar disorder. We     hypothesize that coordinated care via a Care Manager will improve physical and mental     health-related quality of life, improve functioning, and reduce symptoms.   "
181708|NCT00223093|"     Induce tolerance or reduce the amount of immunosuppression after renal transplant patient     (receiving cadaver kidney)with so called TAIZ-monocytes   "
181709|NCT00223106|"     The primary objective of this study is to further evaluate the safety and effectiveness of     the use of a sling device in women for stress and mixed urinary incontinence as well as     vaginal vault prolapse.   "
181683|NCT00222768|"     The purpose of this research study is to use a relatively new technology, called Positron     Emission Tomography (PET), to study how insulin works on sugar in your body's fatty tissue.     PET imaging is a way of obtaining a metabolic image of your internal organs. It does not     involve surgery and is not a high risk process. It has been used successfully to study brain,     heart and more recently, skeletal muscle. In this research study, we will use PET in     combination with Magnetic Resonance Imaging (MRI), to study fatty tissues in healthy people     who do not have diabetes. In the future, we plan to do similar PET/MRI studies in individuals     with type 2 diabetes mellitus (T2DM) and in individuals who are likely to develop T2DM.      Fat tissue might have a lot to do with developing type 2 diabetes. First, it is well     recognized that excess fatty tissues, especially the kind in your belly, increases risk for     the development of T2DM, as well as affecting other ways the body uses insulin. Second, fatty     tissue is a classic target tissue for the action of insulin, which regulates the use of sugar     by fat cells and also regulates the release of fatty acids from fatty tissues. Third, studies     in mice that lack fatty tissue, indicate that severe insulin resistance (lack of a normal     response to insulin) can result. Other types of studies have shown that fatty tissues make     proteins that affect your body's insulin and your appetite in good and bad ways. Yet despite     this importance, we still lack techniques for the study of fatty tissue metabolism in humans.   "
181684|NCT00222781|"     The purpose of this research is to use a recently developed triple-tracer positron emission     tomography (PET) method to study skeletal muscle insulin resistance. Insulin is the hormone     made by your body to control the blood sugar level. Resistance' to insulin could cause poor     blood glucose control (blood sugar levels that are higher than normal). We want to use this     new method to image (look at) the following three things: 1) how insulin affects blood flow     in skeletal muscle 2) how insulin affects glucose (sugar) transport (movement) into muscle,     and 3) how insulin affects glucose metabolism (breakdown) in skeletal muscle of healthy     individuals.      PET imaging is a relatively non-invasive way to obtain a metabolic picture of body organs     and has been used successfully to study brain, heart and more recently skeletal muscle. In     this research study, we will use PET, with three radioactive tracers (markers), to study     skeletal muscle glucose transport in individuals with type 2 diabetes mellitus (type 2 DM)     and in non-diabetic individuals who are either normal weight or overweight/obese   "
181685|NCT00222794|"     This study proposes to examine the effect of atomoxetine on quality of life and negative     symptoms such as social withdrawal, lack of interest in things, lack of thought content, flat     emotions, slowed body movements and lack of drive and motivation in patients with     schizophrenia or schizoaffective disorder. This study also examines the safety of using     atomoxetine along with the conventional antipsychotic in these patients.   "
181686|NCT00222807|"     This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes     mellitus in patients with schizophrenia. As part of the study, we collect     neuroendocrine-immune data on patients with first episode, treatment naive psychosis,     patients with newly diagnosed schizophrenia and normal healthy controls.      Regardless the treatment status, we collect the same neuroendocrine-immune data on the     participants after 2 months.   "
181687|NCT00222820|"     We are doing this pilot study to learn more about four aspects of treating depression:        1. The features of a depressed person’s mood and anxiety and how these features affect a          person’s capacity to get better and stay better.        2. If depressed people with certain features of mood and anxiety respond better to therapy,          medication or a combination of therapy and medication.        3. Whether or not a person’s personality traits affect how they respond to treatment.        4. The gene involved in processing antidepressant medication   "
181688|NCT00222833|"     This is a 2-year study proposing to examine the effects of aripiprazole on heart health     factors such as serum lipids, serum leptin, fasting blood sugar, body weight and blood     pressure. This study also examines the safety of switching to aripiprazole with respect to     changes in the clinical state, preexisting or emergent side-effects, how the brain processes     information and changes in social functioning and quality of life.   "
181689|NCT00222846|"     This randomized study will test a behavioral intervention, based on social cognitive theory     (SCT), to improve regimen adherence in three different groups of people with type 2 diabetes;     (1) those with well controlled blood glucoses and no concurrent chronic renal insufficiency,     (2) those with less well-controlled glucoses and no chronic renal insufficiency, and (3)     those with chronic renal insufficiency regardless of glucose control. The primary aims of     this study are to: (1)determine whether the intervention improves behavioral adherence to the     diabetes self-management regimen including dietary adherence, physical activity, and     capillary glucose self-monitoring; (2)determine whether the intervention improves clinical     outcomes; (3) explore the extent to which self-efficacy is a mediator of adherence,(4)     explore the extent to which the effectiveness of the intervention varies with respect to     glycemic control and nephrovascular complications at baseline, and (5)explore the impact of a     variety of covariates on the effectiveness of the intervention.      Hypothesis #1 is that intervention group participants will perform better than attention     control group participants on various measures of adherence to the diabetes management     regimen. Primary adherence variables will be dietary intake, and physical activity.     Hypothesis #2 is that intervention group participants will have lower HbA1c levels than     attention control group participants.   "
181690|NCT00222859|"     The specific aims of this study are to determine the treatment prescription rates for     Hepatitis C virus (HCV) infection in a cohort of HCV mono-infected, and human     immunodeficiency virus (HIV)-HCV co-infected patients and to identify the reasons for     non-treatment of HCV in these two groups.   "
181691|NCT00222872|"     The main purpose of this study is to determine the safety and effectiveness of three week     daily subcutaneous injections of Parathyroid Hormone-related Protein (1-36). Previous studies     indicated that PTHrP has a skeletal 'anabolic' or bone-building effect, and has shown to     increase bone mineral density in postmenopausal women with osteoporosis. Safety of PTHrP will     be determined by measurements of blood pressure and pulse, serum blood calcium levels and     subjective symptoms. Effectiveness will be measured by changes in measurements of blood and     urine markers of bone turnover.   "
181710|NCT00223119|"     The purpose of this study is to determine the difference in pain scales between absorbable     suture types for second-degree perineal laceration repair.   "
181692|NCT00222885|"     The purpose of this research is to develop a new method to study insulin action using     positron emission tomography (PET). Insulin is the hormone made by your body to control the     blood sugar level. We want to develop a way to image (look at) the following three things: 1)     how insulin affects blood flow in skeletal muscle 2) how insulin affects glucose (sugar)     transport (movement) into muscle, and 3) how insulin affects glucose metabolism (breakdown)     in skeletal muscle of healthy individuals. The long term goal will be to later apply this     method to the study of metabolic diseases, especially type 2 diabetes mellitus and obesity.      PET imaging is a relatively non-invasive way to obtain a metabolic picture of body organs,     and has been used successfully to study brain, heart and more recently skeletal muscle. In     this research study, we will use PET with as many as four radioactive tracers (markers) to     study skeletal muscle glucose transport in healthy volunteers.   "
181693|NCT00222898|"     The purpose of this study is to assist with early and accurate diagnosis of cancer in     pancreatic cysts based on the analysis of DNA obtained by endoscopic ultrasound guided fine     needle aspiration   "
181694|NCT00222911|"     The overall purpose of this study is to examine the combined effect of both dorsiflexion     night splints and medial arch supports and compare it to the effect of these interventions     each by itself in the treatment of plantar fasciitis.   "
181695|NCT00222924|"     This investigation is being carried out to learn more about research findings from a study     that was completed last year. Those findings revealed that within the skeletal muscle cells     of individuals with type 2 diabetes, there was often damage to the mitochondria (the muscle     cell's power source or the machinery of the muscle cell that produces energy). In individuals     with type 2 diabetes, the liver continues to release sugar even when sugar levels are normal;     the pancreas is not able to produce and release insulin normally; and the muscle and fat     cells no longer respond as effectively to insulin. These defects lead to an abnormal rise of     sugar in the blood. In this study, we want both to look more closely at the mitochondria and     see if there is potential for improving mitochondrial functioning (improving the machinery of     the muscle cell that produces energy) and reversing mitochondrial damage through a weight     loss or a combined exercise/weight loss program. The program you get assigned to will be     determined by a process called randomization (like a flip of a coin).   "
181696|NCT00222937|"     The study compares two different forms of voice therapy, Lessac-Madsen Resonant Voice Therapy     and Casper-Based Confidential Flow Therapy. The target population are teachers because they     have the highest risk for developing voice problems. For this study the investigators are     primarily interested in seeing if Lessac-Madsen Resonant Voice Therapy (LMRVT) and     Casper-Based Confidential Flow Therapy (CBCFT) are equally effective at improving vocal     functioning in teachers with phonotrauma, as assessed by the Voice Handicap Index (VHI).   "
181697|NCT00222950|"     This study investigates the effect of margarines supplemented with plant sterol esters on     serum and cardiovascular tissue concentrations of plant sterols. We assume that consumption     of margarine supplemented with plant sterol esters increases serum and cardiovascular tissue     concentrations of plant sterols (sitosterol; campesterol).   "
181698|NCT00222963|"     Obesity has reached epidemic proportions in the United States with roughly 20% of American     children being overweight and has serious consequences such as sleep apnea.Additionally,     obesity is known to result in the earlier onset of puberty . Thus, it can be expected that     obese children take-on adult characteristics at an earlier chronologic age than their     non-obese counterparts. Current guidelines recommend adenotonsillectomy (T+A) as primary and     effective therapy for sleep apnea resulting in polysomnographic resolution in 75-100% of     patients. Small studies have shown that T+A relieves symptoms in obese children but surgical     intervention has been less efficacious in adults. We hypothesize that T+A may be less     efficacious in obese adolescents because of earlier onset of puberty imparting more adult     characteristics. We further hypothesize that the efficacy of T+A will correlate more closely     with Tanner staging than with chronologic age because of the earlier onset of sexual     maturation associated with obesity.   "
181699|NCT00222976|"     The primary objective of this study is to determine whether the route of administration of     naproxen (either by mouth or rectally) influences post-vaginal delivery perineal pain     control.   "
181700|NCT00222989|"     Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with     functional Heartburn.   "
181701|NCT00223002|"     Infection after epidural catheter placement is fortunately rare. When it does happen, the     affected person can become seriously ill.      This study examines which skin disinfectant, chlorhexidine or povidone-iodine, decreases the     number of bacteria that can be grown from the skin washed with each disinfectant prior to     placing an epidural catheter for pain control in labour.   "
181702|NCT00223015|"     Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal     transplant patients are investigated to look for potential interaction between these drugs.      All patient enrolled in this PKI-Study had no changes in the therapy before or because of the     study. Only patients without changes more than 4 weeks were included   "
181703|NCT00223028|"     To investigate in renal transplant recipients the potential drug intreaction between     Sirolimus, Mycophenolt Mofetil and Fluvastatin      All patient enrolled in this PKI-Study had no changes in the therapy before or because of the     study. Only patients without changes more than 4 weeks before startin the study were included   "
181704|NCT00223041|"     Cardiovascular disease after renal transplantation is an important problem. Patients after     renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no     medication, to look for the cardiovascular outcome with and without statins.   "
181857|NCT00226018|"     The purpose of this study is to examine the precision, bias and limits of agreement when     monitoring the neuromuscular block with acceleromyography with and without preload and     compare the method to the gold standard, mechanomyography.   "
181705|NCT00223054|"     In this study the researchers want to investigate genetic polymorphisms of cytochrome 450     enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for     differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus,     cyclosporine A).      All patients who receive one of these drugs can be included and drug blood trough levels,     dosing and genetics are compared.   "
181706|NCT00223067|"     reduce of immunsupression or introduce tolerance with so called TAIZ-monocytes in renal     transplant patients   "
181712|NCT00223145|"     The hypothesis of the proposed study would be that, due to the six months of total androgen     blockade, which would include neoadjuvant hormonal therapy for four months and concomitant     hormonal therapy for two months with irradiation, the investigators could reduce local     failure rates for these two dosage levels, namely 70 Gy and 76 Gy. Since increasing the dose     to the prostate also seems to reduce local relapse rates, the results of the two hormonal     therapy groups would be compared with the results of prostate irradiation at doses of 76 Gy.     This study would verify the possibility of compensating a six Gy dosage increase of radiation     therapy with six months of hormonal therapy between the 70 Gy and 76 Gy groups who received     hormonal therapy, and also match these results with a dose escalation to the prostate of 76     Gy. In the future, this could result in more therapeutic choices, such as reducing the doses     of radiation therapy and, consequently, its related complications, if hormonal therapy proves     to be beneficial; or rather, to continue in the direction of dose escalation for this     intermediate-risk patient group, everything being correlated to the side effects of hormonal     therapy and irradiation.   "
181713|NCT00223158|"     To compare the hypothyroid state in patients with thyroid cancer prepared either by placebo     or L-T3 following L-T4 withdrawal in preparation for whole body scintigraphy. To evaluate the     time needed for TSH elevation (> 30 mUI/L) on placebo vs. L-T3.   "
181714|NCT00223171|"     The objective of this study is to use as a reference the 36-month duration of hormonal     therapy according to the European Organization for Research of the Treatment of Cancer (EORTC     protocol 22863) : namely one-month of total androgen blockade followed by a luteinizing     hormone releasing hormone (LHRH) agonist, all for three years, combined with pelvic and     prostate irradiation; this arm is currently considered to be a standard for high-risk     prostate cancers. The proposed study intends to challenge the duration of hormonal therapy     and verify whether the five-year outcomes in favour of combined treatment in regard to     survival (79% versus 62%) and local control (85% versus 48%) can be transposed for hormonal     therapy that is half as long, namely 18 months, with the possibility of hormone salvage     therapy in the event of biochemical and/or clinical failure (local, regional, or distant);     this applies to both arms. The proposed study will compare survival in the two groups and     evaluate in each one the total duration of initial hormonal therapy, followed by initial     hormonal therapy combined with salvage hormonal therapy, the duration of salvage hormonal     therapy until hormonal therapy resistance, and the side effects of this hormonal therapy,     with everything being related to an assessment of the quality of life of these patients.   "
181715|NCT00223184|"     At present, the only recognised prognostic factor for primary high-grade osteosarcoma is the     histological response to preoperative chemotherapy. Our study was designed to identify new     diagnostic markers that could eventually have a prognostic value and therapeutic     consequences. 80 patients under 20 years of age with primary osteosarcomas were studied while     under treatment by the French Society of Paediatric Oncology OS 94 protocol. Paired normal     and biopsy samples were collected. In addition, surgical resection specimens, following     preoperative chemotherapy, were obtained in many cases. After genomic DNA extraction, an     allelotyping analysis targeting microsatellites was planned. The studied DNA regions     contained mainly Rb, p53, APC, p16, c-met, TWIST, c-kit, erbB2 and topoisomerases genes. The     techniques used in this molecular analysis comprised mainly allelotyping study, quantitative     real-time PCR, gene sequencing , immunohistochemistry. The first results showed the     prognostic value of 7q31 region containing c-met and 5q21 containing APC (Br J Cancer, 2003,     Entz-Werlé et al.), 7p21 containing TWIST (Int J Cancer, 2005, Entz-Werlé et al.) and 4q21     targeting c-kit gene (J Clin Oncol, 2005, Entz-Werlé et al.).   "
181716|NCT00223197|"     The purpose of this research is to determine if pregnenolone supplement is associated with a     reduction in substance use and craving in patients with recurrent major depressive disorder     or bipolar disorder and substance abuse/dependence. This research also wants to explore if     pregnenolone supplements are associated with improvement in psychiatric symptoms and memory,     which are often negatively affected in these patients. It is hypothesized that patients     receiving pregnenolone supplements would show greater improvements in mood symptoms and     memory, and crave substances less than the patients receiving placebo.   "
181717|NCT00223210|"     The purpose of this study is to determine if quetiapine add-on therapy is associated with a     decrease in cocaine use and craving and a greater improvement in mood.   "
181718|NCT00223223|"     The purpose of this research is to determine whether the memory impairment and manic symptoms     (feelings of agitation, overexcitement or hyperactivity) typically seen in those on     corticosteroid therapy is decreased with a seizure medication called levetiracetam compared     to placebo (an inactive substance). Since increased levels of cortisol (the body's natural     corticosteroid) in the body are frequently associated with memory impairment interventions     that may prevent or reverse this are of great importance.      It is hypothesized that patients who are scheduled to receive prescription corticosteroid     therapy who are given levetiracetam pretreatment will show lesser memory impairment and manic     symptoms than those receiving placebo.   "
181719|NCT00223236|"     The purpose of this research is to determine if a citicoline supplement is associated with a     reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder     marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar     type (a psychotic disturbance in which there is a mixture of schizophrenic and     manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore     if citicoline supplements are associated with greater improvement in symptoms of mania and on     memory and cognition (the mental faculty of perception, reasoning, and judgement) in these     patients.   "
181720|NCT00223249|"     The abuse of alcohol is especially common in people with bipolar disorder. However, very     little is known about the pharmacotherapy of people with both bipolar disorder and alcohol     abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are     decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine     add-on therapy is associated with greater improvement in mood, impulsivity, functioning and     decreased alcohol use than placebo.   "
181800|NCT00215462|"     The purpose of this study is to collect anti-tumor activity of vinorelbine when given to     patients with esophageal or gastric tumors. We will also collect information on the     toxicities of vinorelbine in these patients.   "
181721|NCT00223262|"     The purpose of this study is to determine if lamotrigine therapy is associated with     improvement in mood, memory and hippocampal size and function in patients receiving chronic     corticosteroid therapy. Standard care for mood changes associated with corticosteroid     therapy, if severe, includes antidepressants or other medications which can influence mood.     No therapies, other than dose reduction or discontinuation, are currently available for     memory loss associated with corticosteroid treatment. However, very little information is     available on the treatment of either mood or memory changes associated with corticosteroid     treatment, thus the proposed project may improve standard care.   "
181722|NCT00223275|"     The abuse of alcohol is especially common in people with bipolar disorder. However, very     little is known about how to treat people with both bipolar disorder and alcohol     abuse/dependence. The purpose of this research is to determine whether naltrexone add-on     therapy is associated with a greater reduction in alcohol use and alcohol craving than with     placebo (an inactive substance) therapy.   "
181723|NCT00223288|"     This study will examine if depression in a primary caregiver is associated with more     hospitalization or ER visits in children with asthma. This study will also explore whether     treatment for depression in the primary caregivers is associated with improvement in asthma     in school-aged children.      Asthma is a very common childhood disorder of airway inflammation. The causes include     environmental irritants, cold temperature, and infection in the respiratory tract, and     emotional factors can contribute to symptom exacerbation. However, asthma is a disease that     can be well controlled if there is proper medication compliance and careful control of     environmental conditions.      Data suggests that psychiatric symptoms in the mothers of children with asthma are associated     with more asthma related hospitalizations in children. Thus, we want to explore this question     further using more specific diagnostic instruments in order to detect what types of symptoms     are associated with increased asthma related service utilization. Also, we want to explore if     effective treatment of the caregivers' symptoms is associated with decreased hospitalization     and emergency room visits for the child.   "
181724|NCT00223301|"     1. To determine the safety and tolerability of oral Cellcept when used in combination with          weekly intramuscular Avonex in early MS.        2. To document changes in exacerbation frequency,        3. To document the incidence of mild, moderate, and severe exacerbations in the treated          groups (categorical analysis),        4. To document changes in the level of sustained disability as measured by the expanded          disability status score (EDSS) and ambulation index (AI),        5. To document changes in quality of life measures,        6. To assess fatigue with the validated fatigue assessment inventory,        7. Neuroimmunological studies:At baseline, 6 and 12 months after treatment   "
181725|NCT00223314|"     The purpose of the study is to adapt, implement, and evaluate an effective     theoretically-based, high school HIV prevention program,Safer Choices, for higher risk youth     in alternative schools.      Primary Research Question      1. Did the intervention reduce the number of occasions of unprotected sexual intercourse,     number of sexual partners, and the proportion of students currently sexually active among     those receiving the multiple component intervention relative to those students in the     comparison group?   "
181726|NCT00223327|"     This protocol is for a clinical trial to evaluate the reliability of the bite fork as a     diagnostic instrument in subjects with pulpal necrosis and apical periodontitis.   "
181727|NCT00223340|"     The purpose of this pilot study is to collect preliminary information about the best way to     implement an intervention to reduce the risks of heart disease and stroke.   "
181728|NCT00223353|"     The overall purpose of this study is to develop an improved gait analysis system for the real     time acquisition, calculation and interpretation of joint kinematic and kinetic information     using linked segment body model animation to display and visually depict deviations from     normal motion and joint function.      Patients referred to the laboratory for clinical gait analysis are invited to participate in     the project. If interested, subjects are informed by a study investigator of the study goals,     procedures, risks and any benefits. A study investigator is responsible for obtaining     informed consent. Data from normal subjects are used to establish a normative database. Data     from other subjects contributes to the relevant databases of different disorders.   "
181729|NCT00223366|"     This protocol is for a number of in vitro studies using human surgical biopsies and     evaluating the pharmacology and genetics of human nociceptors (pain detecting) neurons   "
181730|NCT00223379|"     This protocol is for a clinical trial evaluating the clinical success of root canal therapy     performed on teeth with chronic apical periodontitis of pulpal origin with either large or     small apical root canal preparation techniques.   "
181744|NCT00223574|"     A long-term low carbohydrate, high monounsaturated fat diet, compared to a high carbohydrate,     low glycemic index diet, results in more rapid progression of diabetes; i.e. increased     fasting glucose and glycated hemoglobin, reduced beta-cell function and insulin sensitivity     and increased free fatty acids. The deleterious effects of a high carbohydrate diet on plasma     lipids are only temporary and do not persist beyond 6 months. A long-term high carbohydrate,     low glycemic index diet, compared to a high carbohydrate, high glycemic index diet, improves     glycemic control and beta-cell function   "
181731|NCT00223405|"     1. To characterize the microstructure (fracture toughness, particle size of ceramic, and          inter-particle spacing) of three ceramic materials        2. To test the hypothesis that lower fracture toughness of glass and/or crystal phase in          ceramics reduce wear damage of enamel.        3. To test the hypothesis that smaller sized crystals reduce wear damage of enamel.        4. To test the hypothesis that larger inter-particle spacing reduces wear damage of enamel.        5. To test the hypothesis that equivalent wear patterns exist in all directions between          enamel versus enamel and ceramic versus enamel.        6. To test the hypothesis that bite force does not correlate with wear rates.        7. To test the hypothesis that salivary flow does not correlate with wear rates.        8. To test the hypothesis that a greater amount of wear is not associated with a loss in          vertical dimension of occlusion.        9. To test the hypothesis that a greater amount of wear does not correlate with secondary          cementum deposition as part of the passive eruption process.       10. To test the hypothesis that maximum wear occurs early and wear rates level off within          the first two years.       11. To test the hypothesis that in vitro wear analysis does not correlate with in vivo wear          measurements   "
181732|NCT00223418|"     STUDY PURPOSE: To study whether patients who have schizophrenia or schizoaffective disorder     and are randomly assigned to switch to aripiprazole prior to participation in a brief     vocational skills training (VST) will have improved cognitive functioning and learn more in     VST than those randomly assigned to stay on olanzapine. There is evidence that VST is     important in improving role functioning for schizophrenia patients, however, cognitive     impairments limit the ability of some patients to benefit from skills training approaches.     Patients switched from olanzapine to aripiprazole improve in terms of verbal learning and     verbal learning has been shown to be a strong predictor of community outcome. It is unclear     whether the cognitive benefits of switching to aripiprazole extend to improve learning of     vocational skills.   "
181733|NCT00223431|"     Objectives: The purpose of this research was to determine the clinical success rate of a     lithia-disilicate-based core ceramic (Ivoclar, Vivadent Corp.) for use in posterior fixed     partial dentures (FPDs) as a function of bite force, cement type, connector height, and     connector width.      Methods: Thirty ceramic FPD core frameworks were prepared using a hot-pressing technique and     a lithia-disilicate-based core ceramic. The maximum clenching force was measured for each     patient prior to tooth preparation. Connector heights and widths were measured for each FPD.     Patients were recalled yearly after cementation for two years and evaluated using eleven     clinical criteria. All FPDs were examined by two independent clinicians and rankings for each     criterion were made from 1 to 4 with 4 = excellent and 1 = unacceptable.      The aims of this research were:        1. To test the hypotheses that three-unit fixed partial dentures (FPDs) of a high-strength          core ceramic will exhibit good-to-excellent clinical performance (based on 11 evaluative          criteria) and that they will adequately resist fracture in posterior situations          (excluding third molars) if fabricated with the minimal connector size (4 mm x 4 mm).        2. To test the hypothesis that a reinforced glass ionomer cement (ProTec CEM, Ivoclar,          Vivadent), when used to cement core ceramic crowns in posterior FPDs, will be associated          with significantly less marginal quality, but similar fracture resistance of the ceramic          crowns compared with the marginal quality associated with a dual cure resin cement          (Variolink® II, Ivoclar Vivadent AG, Schaan, Liechtenstein).        3. To test the hypothesis that there is no significant difference in tooth sensitivity          associated with FPDs cemented with the glass ionomer cement and dual-cure resin cement.   "
181734|NCT00223444|"     The purpose of the study is to better understand how genetic factors influence individual     sensitivity to alcohol.   "
181735|NCT00223457|"     The purpose of this study is to evaluate the coorelation between patient factors, health care     provider factors, drug factors and compliance in patients with relapsing forms of multiple     sclerosis (RMS) treated with Disease Modifying Agents (DMA). We hypothesize that a number of     factors influence compliance with DMA's.   "
181736|NCT00223470|"     This clinical trial evaluates the role of cytokines in patients needing root canal treatment     with diagnosis of necrotic pulp and chronic apical periodontitis   "
181737|NCT00223483|"     This research study goal is to analyze the plasma and the cells that make up part of the     immune system. We want to learn how the plasma and cells work. These may influence why one     person will develop an infection and another will not, or why one person develops severe     symptoms of a disease while others remain without symptoms.   "
181738|NCT00223496|"     1. Determine the change in symptomatology and function in refractory bipolar depression,          when treated with combination of DEP+AZP for a period of 12 weeks        2. Determine the tolerability and safety of AZP added to DEP in the treatment of refractory          bipolar depression   "
181739|NCT00223509|"     -  To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the          acute treatment of patients in a mixed state of bipolar disorder.        -  To evaluate the efficacy and of a combination of LAM+existing regimen of mood          stabilizers in the maintenance treatment of patients with mixed state of bipolar          disorder   "
181740|NCT00223522|"     The purpose of this study is to prospectively examine adherence to oral atypical     antipsychotics in patients with schizophrenia. We are psrticularly interested in examining     the level of agreement among self-report, physician impressions and objective measures of     adherence. We believe that physicians, casemanagers, and clients significantly overestimate     the level of adherence.   "
181741|NCT00223535|"     The purpose of this study is to examine whether patients who participate in cognitive     remediation prior to a skills training program learn and perform the skills better than     patients who do not participate in cognitive remediation.   "
181742|NCT00223548|"     The purpose of this study is to determine wether Mesna could prevent contrast-induced     nephropathy   "
181743|NCT00223561|"     The primary purpose of this study is to determine the effects of methylphenidate versus     placebo on driving ability of adult ADHD patients.   "
181745|NCT00223587|"     On-the-road driving performance of untreated seasonal allergic rhinitis patients during the     allergic season (exposed) is compared to driving performance outside the allergic season (in     winter, not-exposed).   "
182090|NCT00219674|"     The purpose of the research is to determine the best automated external defibrillator (AED)     training approach for high-risk patients and their family members with regard to AED skills     retention and psychological adjustment.   "
181746|NCT00223600|"     1062 children at the age of 7 months and their families were randomized 1:1 in an     intervention arm and a control arm. The intervention families has received child-oriented and     individualized nutritional and life-style counseling that aims at decreasing child's exposure     to the known environmental atherosclerosis risk factors. The controls children receive     information as given at the well-baby clinics and in school health care of children and     adolescents. The hypothesis is that the intervention children have healthier food habits and     serum serum lipid and lipoprotein concentrations than the controls, fewer of them start     smoking, and their physical activity level is higher than that of the controls.   "
181769|NCT00223912|"     The purpose of this study is to determine if exercise affects the clotting of blood     (hemostasis). The effect of exercise on hemostasis will be determined in persons with spinal     cord injury, a population reported to have an increased prevalence of cardiovascular disease     (CVD). It is expected that this study will increase our understanding of CVD in persons with     SCI, and it will eventually help reduce the occurrence of premature heart disease.   "
181747|NCT00223613|"     Children born in Turku, Oulu and Tampere university cities in Finland are screened at birth     for HLA alleles that carry increased risk to or protection from development of type 1     diabetes. Children carrying increased risk are followed at 3-12-month intervals for     development of diabetes-associated autoantibodies. Children having at least two types of     autoantibodies (of the four measured) in at least two consecutively drawn samples are     randomized to receive daily intranasal insulin or placebo in a double-blinded 1:1 trial.     Hypothesis is that intranasal insulin delays or prevents development of clinical type 1     diabetes. The primary outcome measure is development of clinical diabetes.   "
181748|NCT00223626|"     Cocaine addiction is a serious health problem with no available medical treatment for     preventing relapse. Topiramate, a medication which lowers dopamine levels, may have the     ability to diminish cocaine cravings in addicts. The purpose of this study is to determine     the effectiveness of topiramate in reducing cocaine's rewarding effects in individuals     addicted to cocaine.   "
181749|NCT00223639|"     In the last decade, there has been an explosion of new knowledge of the neuroscientific basis     of alcohol-seeking behavior. Briefly, medications that modulate mesolimbic dopamine pathways     by facilitating gamma amino butyric function and inhibiting the action of excitatory amino     acids should reliably diminish alcohol's rewarding effects. Topiramate (a     sulfamate-substituted fructo-pyranose derivative) has these characteristics. In support of     this concept, we have shown in a phase-II-type medications clinical trial that topiramate is     significantly superior to placebo at improving drinking outcomes and decreasing craving among     (N = 150) alcohol-dependent individuals. Using the carefully controlled environment of the     human laboratory, we are submitting a revised application containing a set of systematic     studies to assess directly the mechanistic neuropharmacological processes that are associated     with topiramate's anti-drinking effects. This will provide a more comprehensive understanding     of the neurobiology of alcohol-seeking behavior and aid in the development of even more     effective compounds for the treatment of alcohol dependence. Thus, the specific aims of the     project are to: 1) determine the dose-relationship of acute effects of topiramate to reduce     alcohol effects related to its abuse and addiction potential. We hypothesize that topiramate     will reduce alcohol-induced craving, reward, and euphoria; 2) determine whether chronic     treatment with an acutely effective dose of topiramate produces substantial reductions in     alcohol-related cue-induced craving, thereby decreasing the potential for treatment relapse.     We hypothesize that chronic topiramate administration will desensitize (reduce) alcohol     craving produced by alcohol-related sensory cues; and 3) determine whether topiramate     interactions with and without alcohol are associated with neurocognitive impairment. Clinical     studies including ours have suggested that topiramate use may be associated with     neurocognitive effects such as loss of concentration and memory impairment. In our own study,     these effects were mild and not associated with reduced treatment compliance. Since alcohol's     ability to produce neurocognitive impairment may be mediated through similar ionic mechanisms     to that of topiramate, the proposed human laboratory setting affords us the unique     opportunity to more clearly delineate topiramate's neurocognitive effects in both the     presence and absence of alcohol. This study supports NIAAA's goal to develop effective     medications for treating alcoholism and to understand the basic underpinnings of the disease.   "
181750|NCT00223652|"     The purpose of this study is to examine the efficacy of telephone-administered     cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by     community-based outpatient clinics (CBOCs) in the Veteran's Integrated Service Network (VISN)     21, which serves rural areas in Northern California and (VISN) 12, which serves rural areas     surrounding the Hines, IL VA Hospital.   "
181751|NCT00223665|"     Sometimes blood levels of prostatic specific antigen (PSA) will rise in men who have had     prostate surgery or received radiation therapy for localized prostate cancer. A low value for     the PSA is more desirable as is may indicate no tumor growth. Giving the hormone therapy     intermittently (in cycles of treatment and off treatment periods) appears to delay the change     of prostate cancer to a type of prostate cancer that resists hormone therapy. If it does, the     prostate cancer will be treatable for a longer period of time, as well as improve the quality     of life. Mental functioning is monitored during therapy to see if this treatment has any     impact on memory or ability to carry out tasks. In addition, extra tubes of blood are     obtained to test for Amyloid-B protein (AB protein) whose presence may be associated with     problem solving decline.   "
181752|NCT00223678|"     A study to determine the effect on renal function in renal transplant patients with biopsy     proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin     inhibitor (CI) triple drug regimen to a Rapamycin based triple drug regimen or maintained on     their CI protocol   "
181753|NCT00223691|"     The autonomic nervous system serves multiple regulatory functions in the body, including the     regulation of blood pressure and heart rate, gut motility, sweating and sexual function.     There are several diseases characterized by abnormal function of the autonomic nervous     system. Medications can also alter autonomic function. Impairment of the autonomic nervous     system by diseases or drugs may lead to several symptoms, including blood pressure problems     (e.g., high blood pressure lying down and low blood pressure on standing), sweating     abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for     these patients are limited. We propose to study patients autonomic failure and low blood     pressure upon standing and determine the cause of their disease by history and examination     and their response to autonomic testing which have already been standardized in our     laboratory. Based on their possible cause, we will tests different medications that may     alleviate their symptoms.   "
181766|NCT00223860|"     There is evidence that has shown that serum testosterone levels are low in persons with     chronic spinal cord injury (SCI). The question arises as to whether the defect in     testosterone production is from the hypothalamic pituitary system (part of the brain that     plays a role in testosterone release) or from the male testes. Studies to date are     inconclusive. This study, will examine if persons with SCI has a normal hormonal regulation     of the male hormone testosterone in comparison to persons who are able-bodied. This will help     understand the physical and metabolic changes that occur in persons with SCI.   "
181767|NCT00223873|"     The purpose of this study is to determine the effect of penile vibratory stimulation on the     muscle spasticity of men with chronic spinal cord injury.   "
181768|NCT00223899|"     To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5     mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per     tumor) followed by electroporation.   "
181770|NCT00223925|"     Cytomegalovirus (CMV) infections remain a significant problem following various types of     transplants that are associated with strong immunosuppressive therapy. Maribavir is a new     oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV     drugs. This study will test the safety and anti-CMV activity of different doses of maribavir     when given as CMV prophylaxis following stem cell transplants.   "
181771|NCT00223938|"     This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the     maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients     receiving Erythropoietin.   "
181754|NCT00223704|"     Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary     bypass (CPB). CPB is associated with significant morbidity including the transfusion of     allogenic blood products, inflammation and hemodynamic instability. In fact, approximately     20% of all blood products transfused are associated with coronary artery bypass grafting     procedures. Transfusion of allogenic blood products is associated with well-documented     morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to     increased blood product transfusion in the perioperative period. The current proposal tests     the central hypothesis that endogenous bradykinin contributes to the hemodynamic,     fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will     reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test     the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE     inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the     hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic,     and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that     bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in     patients undergoing CPB. These studies promise to provide important information regarding the     effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in     patients undergoing CPB.   "
181755|NCT00223717|"     Supine hypertension is a common problem that affects at least 50% of patients with primary     autonomic failure. Supine hypertension can be severe, and complicates the treatment of     orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg,     fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also     cause target organ damage in this group of patients. The pathophysiologic mechanisms causing     supine hypertension in patients with autonomic failure have not been defined.      In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29     with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients     had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood     pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in     21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and     plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with     AF and supine hypertension. (Shannon et al., 1997).      Our group has showed that a residual sympathetic function contributes to supine hypertension     in patients with severe autonomic failure and that this effect is more prominent in patients     with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor     response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF     patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12     +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine     hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor     blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate     did not change in either group. This result suggests that residual sympathetic activity     drives supine hypertension in MSA; in contrast, supine hypertension in PAF.      It is hoped that from this study will emerge a complete picture of the supine hypertension of     autonomic failure. Understanding the mechanism of this paradoxical hypertension in the     setting of profound loss of sympathetic function will improve our approach to the treatment     of hypertension in autonomic failure, and it could also contribute to our understanding of     hypertension in general.   "
181756|NCT00223730|"     Patients undergoing bone marrow transplantation (BMT) and peripheral blood stem cell     transplants (PBSCT) frequently develop organ dysfunctions, much of which may be initiated by     damage to the liver and to cells lining blood vessels.      We, the researchers at Vanderbilt University, propose to perform a randomized, prospective,     double-blind, placebo-controlled study of 144 patients undergoing allogeneic marrow     transplantation. The treatment is aimed at supporting hepatic urea cycle function in patients     receiving escalated dose chemotherapy/BMT. By so doing we hope to prevent development of     hepatic venoocclusive disease (HVOD) and acute lung injury (ALI), two morbid complications of     BMT. Patients will be randomized to receive oral citrulline, a urea cycle amino acid     intermediate, or placebo beginning before conditioning therapy and continuing until 21 days     after BMT. All patients will be followed for 100 days after study enrollment with intensive     data collection.   "
181757|NCT00223743|"     The purpose of this pilot study is to obtain information whether the medication zonisamide     reduces tremor in persons with essential tremor and is well tolerated.   "
181758|NCT00223756|"     The primary purpose of this research study is to evaluate the effectiveness of a new     outpatient low vision rehabilitation program that is targeted to serve legally blind veterans     with central vision loss. The hypothesis is that veterans in the treatment group will     self-report less difficulty performing daily activities than veterans in the control group     who are on a waiting list for VA low vision or blind rehabilitation programs.   "
181759|NCT00223769|"     The purpose of this study is to determine the effect of oxandrolone on the function and     quality of life of patients with chronic spinal cord injury.   "
181760|NCT00223782|"     The purpose of this study is to determine whether individuals with diabetic peripheral     neuropathy can learn to change the way they walk in order to reduce the pressures underneath     the feet, which may lead to a reduced risk of foot ulceration.   "
181761|NCT00223795|"     The purpose of this study is to assess whether the single point cane will relieve pain and     disability in overweight or obese people with knee OA through altered joint biomechanics and     what factors influence acceptance of cane use.   "
181762|NCT00223808|"     The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose     therapy program for persons recovering from a recent stroke using mechanically-assisted upper     limb movement with a device called MIME. A control group receives additional occupational     therapy without the use of MIME.   "
181763|NCT00223821|"     The primary objective of this project is to evaluate whether enhancing drug therapy with     components of behavioral training, including pelvic floor muscle rehabilitation, results in     better outcomes than drug therapy alone for urge incontinence in community-dwelling women.   "
181764|NCT00223834|"     This study will examine the barriers and supports for entering and receiving work-related     services for veterans with a serious mental illness. It will also determine the effectiveness     of a brief motivational interviewing intervention designed to help veterans receive these     services.   "
181765|NCT00223847|"     The purpose of this study is to investigate the effects of intensive, constraint induced     language therapy (CILT) for individuals with chronic aphasia compared with traditional     aphasia therapy. The specific objectives of the proposed research are to determine the     effects of therapy type (CILT vs. traditional) and dose density (intensive or distributed) on     speech therapy outcome. In addition, we will investigate the functional and qualitative     impact of these interventions on functional communication.   "
181813|NCT00215657|"     An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and     Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients   "
181772|NCT00223951|"     The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in     healthy normal volunteers   "
181775|NCT00223990|"     This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate     malaria vaccine is being developed for the routine immunization of infants and children     living in malaria-endemic areas. This vaccine would offer protection against malaria disease     due to the parasite Plasmodium falciparum.      Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve     adults and 40 adults and 90 children living in malaria-endemic regions.      This study will investigate whether the candidate vaccine prevents malaria disease for 6     months post-vaccination.      One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine.   "
181776|NCT00224003|"     A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal     guardian had provided signed informed consent, and who had satisfied the inclusion and     exclusion criteria of the study.   "
181777|NCT00224016|"     This study will evaluate the safety and effectiveness of an anticholinergic drug treatment     administered by transdermal patch to treat overactive bladder in children who have a     neurological condition (e.g. spina bifida) that contributes to their overactive bladder.   "
181778|NCT00224029|"     This study will evaluate the efficacy and safety of an anticholinergic drug treatment     administered by transdermal patch to treat overactive bladder in adults who have spinal cord     injury.   "
181779|NCT00224042|"     This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate     (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease     patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.   "
181780|NCT00224055|"     This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate     (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease     patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow     to make more red blood cells).   "
181781|NCT00224068|"     This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of     intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to     epoetin alfa among anemic cancer patients receiving chemotherapy.   "
181782|NCT00224081|"     This study explores the safety and efficacy of intravenous iron therapy in anemic     hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but     low to normal transferrin saturation.   "
181783|NCT00224094|"     This study compares the effects of 12 weeks of treatment with transdermal versus oral     estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal     women.   "
181784|NCT00224107|"     A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is     safe and effective. The study lasts approximately 20 weeks.   "
181785|NCT00215267|"     The overall objective of the project is to contribute to an increased knowledge about the     effect of praziquantel on schistosomiasis related morbidity and re-infection level among     communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of     improving the strategies for morbidity control.      The study will be carried out in a high transmission area along Lake Victoria, in Mayuge     district. It will be a randomised intervention study, comparing a single praziquantel     treatment (40mg/kg) with two standard doses administered two weeks apart.   "
181786|NCT00215280|"     Mansonella perstans (M. perstans) infection is widespread in Uganda. Knowledge about the     epidemiology of this infection, and of the morbidity it induces is poor, and no effective     treatment is available. The study aims at providing data on diagnostic, epidemiological,     morbidity and treatment aspects of M. perstans infections in Uganda.   "
181787|NCT00215293|"     The purpose of this study is to determine the clinical success of the Cervical I/F Cage in     treatment of one or two adjacent levels of degenerative disc disease of the cervical spine     compared with standard of care treatment using either autograft, autograft with a plate or     allograft with a plate   "
181788|NCT00215306|"     The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc     compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at     one level of the lumbar spine (either L4/L5 or L5/S1).   "
181789|NCT00215319|"     The purpose of this study is to determine the clinical success of DePuy Spine Titanium     Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one     or two levels of degenerative disc disease of the lumbar spine. The observed success rate at     24 months will be compared to an historical control group treated with the Lumbar I/F Cage     with VSP System.   "
181790|NCT00215332|"     To assess the clinical and radiographic outcomes through 5-years following treatment with     CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one     level (L4-S1).   "
181791|NCT00215345|"     The purpose of this clinical trial is to find out the safety and effectiveness as well as     patient’s quality of life on the combination of Taxotere and celecoxib on patients with     hormone refractory prostate cancer. Celecoxib (Celebrex) is an FDA approved drug to treat     arthritis. Taxotere (Docetaxel) is an FDA approved chemotherapy drug to treat certain forms     of cancer. Both drugs have demonstrated evidences of tumor blood vessel suppression and     combination of these two drugs could possibly arrest further tumor growth or make the tumor     decrease in size.   "
181792|NCT00215358|"     The purpose of this study is to determine which dose of the investigational drug is safest     and most effective compared to the control drug.   "
181793|NCT00215371|"     The purpose of this study is to determine which dose of the investigational drug is safest     and most effective compared to the control group.   "
181794|NCT00215384|"     The purpose of this study is to determine which dose of the investigational drug is the most     safe and effective compared to the control drug.   "
181795|NCT00215397|"     The purpose of this study is to determine which dose of the investigational drug is the most     safe and effective in the treatment of asthma compared to the control drug.   "
181796|NCT00215410|"     The purpose of this study is to determine the most safe and effective dose of the     investigational drug in comparison with a control drug and placebo.   "
181797|NCT00215423|"     The purpose of this study is to determine which dose of the investigational drug is the most     safe and effective for the treatment of COPD compared to the control drug   "
181801|NCT00215501|"     The purpose of this study is to test the safety of irinotecan and cisplatin in combination     with either capecitabine or continuous infusion 5-fluorouracil and to see what effects (good     and bad) these have on patients with unresectable, advanced solid tumors.   "
181802|NCT00215514|"     The main purpose of this trial is to determine how well patients with gastric or     gastroesophageal junction adenocarcinoma respond to chemotherapy with epirubicin, cisplatin     and 5-fluorouracil followed by continuous infusion 5-fluorouracil chemotherapy given along     with radiation therapy.   "
181803|NCT00215527|"     The investigators are studying the use of enzyme replacement therapy into the spinal fluid     for treatment of spinal cord compression in the Hurler-Scheie and Scheie forms of     mucopolysaccharidosis I (MPS I). Funding source -- FDA OOPD   "
181804|NCT00215540|"     SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to     prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia     (BPD), in premature infants who have required continued intubation and received surfactants     for the prevention or treatment of respiratory distress syndrome (RDS).   "
181805|NCT00215553|"     Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to     usual care alone consisting primarily of assisted (mechanical) ventilation in patients with     acute respiratory distress syndrome(ARDS).   "
181806|NCT00215566|"     This study will evaluate the safety, tolerability and pharmacodynamics of the investigational     drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.   "
181807|NCT00215579|"     As many as 75 percent of patients with schizophrenia have difficulty taking their oral     medication on a regular basis. This may lead to worsening of symptoms. Clinicians commonly     respond to these problems by adding adjunctive medications, despite the absence of systematic     studies that support such practices. It is possible, however, that in many of these cases,     the unstable course and/or unsatisfactory treatment response reflects incomplete adherence     with the originally prescribed oral antipsychotic, rather than a need for adjunctive     medications. This study will examine whether switching patients who demonstrate an unstable     course and/or an unsatisfactory clinical response to a long-acting injectable preparation as     the primary antipsychotic may enhance medication adherence and improve outcomes.   "
181808|NCT00215592|"     To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients     with refractory partial seizures.   "
181809|NCT00215605|"     The purpose of this study is to determine the best and safest dose of XL184 administered     orally. XL184 is a new chemical entity that inhibits VEGFR2, MET and RET, kinases implicated     in tumor formation, growth and migration. To determine the highest safe dose, subjects will     receive different amounts of the drug. The first group of subjects will receive the lowest     dose of XL184. As long as no medically unacceptable side effects are noted, the dose will be     increased for the next group. When the maximum tolerated dose (MTD) is reached, at least 20     subjects with Medullary Thyroid Cancer (MTC) will be enrolled to evaluate the effect of XL184     in this population.   "
181810|NCT00215618|"     The purpose of this research is to determine the proportion of women who achieve permanent     cessation of bleeding after Uterine Balloon Therapy (UBT) for the treatment of heavy uterine     bleeding.   "
181811|NCT00215631|"     Because of the high incidence of post-radiation erectile dysfunction (ED), up to 72% after     external-beam radiotherapy, this patient category represents a most difficult therapeutic     challenge. Therefore, prevention of ED could be more effective than treatment. Tadalafil, a     new phosphodiesterase type 5 inhibitor, has been recently introduced. No studies have     investigated the efficacy of tadalafil in preventing ED in patients undergoing radiotherapy     for prostate cancer. Efficacy of tadalafil can last up to 36 hours after intake. This will     result in a prolonged and continuos enhancement of penile vascular responsiveness. This     randomized, double-blind, placebo-controlled study has been designed to evaluate the efficacy     of 20-mg of tadalafil administered for 12 months in maintaining erectile function of potent     patients undergoing external-beam radiotherapy for prostate cancer.   "
181812|NCT00215644|"     The purpose of this study is to compare the effectiveness and safety of experimental     treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Subjects invited to take     part have metastatic cancer of the esophagus (gullet) or stomach.   "
181815|NCT00215683|"     This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was     to be treated until he was discontinued or withdrawn from the study, or a marketing     authorization for degarelix had been obtained.      The study was terminated when all ongoing participants had been treated for at least 5 years     (including one year in the main study).   "
181816|NCT00215696|"     The primary purpose of this study is to determine whether treatment with an experimental gene     therapy (BIOBYPASS®) will reduce angina in study participants by stimulating the growth of     new blood vessels. This will be measured by testing whether participants are able to exercise     longer without experiencing angina after treatment, as compared to before treatment.      Additionally, this study will collect information about any side effects that might be     related to the treatment with the experimental therapy.   "
181817|NCT00215709|"     This pilot study is designed to determine the feasibility and safety of administering     docetaxel at various dosing levels on a bi-weekly schedule in older men with hormone     refractory prostate cancer.   "
181818|NCT00215722|"     The first phase II trial with cetuximab and FOLFOX, as 1st line therapy for MCRC, presented     at ASCO 2004, showed a 81% response rate, with no unexpected toxicities for the combination.      This study is aimed at establishing the efficacy and safety of the combination     cetuximab/XELOX as first line therapy in patients with MCRC.   "
181819|NCT00215735|"     Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds   "
181820|NCT00215748|"     This study is to explore the feasibility of an alternative dose of dexamethasone     pre-medication in older breast and lung cancer patients who are receiving weekly docetaxel     chemotherapy.   "
181821|NCT00215761|"     Comparison of AF-Burden in patients with paroxysmal atrial fibrillation and the necessity of     a Dual-Chamber-Pacemaker-Therapy either with a DDD[R]60-Stimulation or AF prevention pacing.     All Patients were stratified according to their existing drug therapy, e.g. Beta-Blocker or     ACE-Inhibitor.   "
181822|NCT00215774|"     A randomized trial to test the hypothesis that short-term pharmacological reversal of     electrical remodeling after cardioversion is equally efficient to prevent recurrent atrial     fibrillation as standard long-term antiarrhythmic therapy.   "
181823|NCT00215787|"     Although nasal polyposis has been recognized as an inflammatory process for many years, the     true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence     rate after surgery has been reported as high as 87% within the first year after surgery.     Anecdotally the Principal Investigator found an incidence of pH probe-proven     laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his     number of cases was small, the incidence of recurrence of polyps in these patients was 17%.      The PI believes that such an association is too great to be explained by chance alone, and     deserves further study. He anticipates two contributions to the literature from this study,     the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients     with polyposis, and the second showing the impact of reflux treatment on the recurrence rate     of the polyps, initially after one year of therapy.   "
181824|NCT00215800|"     multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy.   "
181825|NCT00215813|"     This is an open label study of Ampligen in patients with chronic fatigue syndrome.   "
181826|NCT00215826|"     The purpose of this trial is to conduct a randomized dose-ranging study to evaluate the     safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and     immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute     respiratory syndrome (SARS) or possible SARS. The primary objective of this pilot study is to     determine an Alferon LDO dose level that increases or upregulates genes known to be mediators     of interferon response. Secondary endpoints include the development of SARS symptomatology,     rate of hospitalization, and mortality rate. In the event that no subjects with recent     exposure to a person with SARS or possible SARS are available, this study will be conducted     with 10 normal volunteers.   "
181827|NCT00215839|"     Objectives:      Primary To evaluate the safety, tolerability, and efficacy of Peginterferon a-2a plus     Ribavirin for the treatment of chronic hepatitis C (CHC) infection in persons co-infected     with human immunodeficiency virus (HIV) who have failed to achieve a sustained virologic     response following previous interferon therapy.      Secondary        -  To evaluate the virological response to Peginterferon a-2a plus Ribavirin at weeks 12          and 24 as compared to baseline values.        -  To evaluate the sustained virological response Peginterferon a-2a plus Ribavirin at          post-treatment weeks 4, 12, and 24 as compared to baseline.        -  To evaluate the histological effects of long-term Peginterferon a-2a therapy through          comparison of liver biopsy results following 96 weeks of Peginterferon a-2a therapy to          baseline values.        -  To evaluate the safety and tolerability of long-term Peginterferon a-2a therapy in          patients who have previously failed to achieve a sustained virologic response following          interferon therapy.        -  To investigate the effects of long-term Peginterferon a-2a therapy on clinical outcomes          of HIV disease.      Study Design:      All qualifying patients will enter the treatment phase and be dosed as follows:      Peginterferon a-2a 180mg by subcutaneous route once weekly plus      Ribavirin:        -  800 mg (400 mg bid) if body weight < 65 kg        -  1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg        -  1200 mg (600 mg bid) if body weight > 85 kg      Patients with undetectable levels of HCV-RNA at Treatment Week 24 will continue on previously     assigned Peginterferon a-2a plus Ribavirin combo-therapy for an additional 24 weeks. Patients     with detectable levels of HCV-RNA will be randomized to Peginterferon a-2a mono-therapy or no     treatment for 72 weeks.        -  Group A: Peginterferon a-2a 90mg mono-therapy for 72 weeks.        -  Group B: No CHC therapy for 72 weeks      All patients entering the study are required to have a baseline liver biopsy (within 18     months of study entry). Patients entering the 72-week randomized arm of the trial will have a     post-study liver biopsy upon completion of the trial.      Study Population:      100 HIV infected adults with chronic hepatitis C infection who have failed to achieve a     sustained virologic response following previous interferon therapy.      Dosage and Administration:      Combo-therapy: Peginterferon a-2a 180mg by subcutaneous route once weekly plus      Ribavirin:        -  800 mg (400 mg bid) if body weight < 65 kg        -  1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg        -  1200 mg (600 mg bid) if body weight > 85 kg Mono-therapy: Peginterferon a-2a 90mg in 1mL          solution administered subcutaneously once weekly.      Efficacy Evaluations:      Laboratory analysis, liver biopsies, quality of life assessments, and changes in     Peginterferona-2a and Ribavirin dosages will be obtained.      Safety Evaluations:        -  Assessment of laboratory evaluations        -  vital signs        -  incidence and severity of adverse experiences        -  dose adjustments        -  premature withdrawal for safety reasons        -  progression of disease as measured by HCV viral load        -  AIDS defining events   "
181828|NCT00215852|"     To conduct a randomized dose-ranging study to evaluate the safety and activity of orally     administered low dose interferon alfa-n3 as an immunomodulator in subjects with asymptomatic     HIV-1 infection. The primary endpoints of the study will include an increase or upregulation     in genes known to be mediators of interferon response. Secondary endpoints will include the     absolute CD4 count and plasma HIV RNA levels.   "
181856|NCT00226005|"     The purpose of this research study is to find out if an experimental drug called     PTK787/ZK222584 might be effective against advanced or metastatic pancreatic cancer.      In order for tumors to grow and spread to other parts of the body, they need to have a     growing blood supply. Tumor cells have been shown to produce substances that stimulate the     abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel     cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the     growth of new blood vessels. A drug that interferes with the growth of new blood vessels     might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients     and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rarely,     it might be possible to stop tumor growth without harming normal tissues.   "
181829|NCT00215865|"     HRN-003 STUDY SYNOPSIS      OBJECTIVE: To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin     among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing.      OVERVIEW OF STUDY DESIGN: This is a multi-center, randomized, open-label clinical trial using     PEGIntron weight-adjusted dose by subcutaneous injection weekly + ribavirin by mouth twice     daily for 48 weeks OR PEGIntron fixed dose by subcutaneous injection weekly + ribavirin by     mouth twice daily for 48 weeks.      STUDY POPULATION: 600 Adult patients with chronic hepatitis C virus infection who have     previously failed to achieve a sustained virologic response following interferon alfa or     interferon alfa-2b plus ribavirin therapy.      DOSAGE AND ADMINISTRATION: Eligible participants will be randomized to receive PEGIntron     weight-adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth     twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if     weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for     48 weeks.      EFFICACY EVALUATIONS: Laboratory analysis, quality of life assessments, and change in study     medication doses will be obtained.      SAFETY EVALUATIONS: Assessment of laboratory evaluations, vital signs, incidence and severity     of adverse experiences and progression of disease, as measured by HCV viral load.      STUDY DESIGN      This is a treatment protocol to evaluate the antiviral efficacy, safety and tolerability     polyethylene glycol (PEG) conjugated interferon alfa-2b (PEGIntron) for the treatment of     chronic hepatitis C virus infection in patients who have previously failed to achieve a     sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin     therapy. Patients will be stratified according to their response to the previous course of     therapy (i.e. non-reponse or relapse virologic pattern      This is a multi-center, randomized, open-label clinical trial that will involve approximately     25 sites with an anticipated enrollment of 600 patients over a six-month period.      Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1.5     mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks     OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by     subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks.        -  Group A: PEGIntron weight -adjusted dose (1.5 mg/kg) by subcutaneous injection weekly +          ribavirin 400 mg by mouth twice daily for 48 weeks (Total therapy x 48weeks).        -  Group B: PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80          KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for an          additional 48 weeks (Total therapy x 48 weeks).   "
181830|NCT00224120|"     A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is     safe and effective. The study lasts approximately 20 weeks.   "
181831|NCT00224133|"     A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term     safety.   "
181832|NCT00224146|"     This study evaluates changes in health related quality of life outcomes in patients using     Oxytrol(r)   "
181833|NCT00224159|"     The purpose of this research is to improve our understanding of the effects that taking     cholesterol reducing pills have on dietary behavior as well as other health related behaviors   "
190170|NCT00334646|"     This study is designed to evaluate the potential pharmacokinetic interaction between oral     GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.   "
181834|NCT00224172|"     The aim of this study is to construct a prognostic model to identify risks of poor outcomes     at one year following hospital discharge of patients treated in an ambulatory cate setting.     The study will incorporate pre-hospitalization characteristics, hospitalization events,     comorbidity burden, psychosocial measures and post-hospitalization care characteristics to     predict re-hospitalization and mortality at one year.   "
181835|NCT00224185|"     The purpose of this study is to obtain biologic materials from the blood and lungs of normal     individuals to establish a set of normal range for various parameters. These will provide     important information when applied to individuals with various pulmonary diseases, and will     help in understanding of the etiology and pathogenesis of various lung diseases.   "
181836|NCT00224198|"     The purpose of this protocol is to obtain biologic materials from the blood and lungs from     patients with lung disease in order to develop an understanding of the etiology and     pathogenesis of these disorders. General admission criteria for this project will require at     least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-ray     consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4)     lung biopsy consistent with lung disease; (5) family history of lung disease; and (6)     patients with diseases of organs with known association with lung disease.   "
181837|NCT00224211|"     This project is being done in order to determine if the music of Mozart will have a soothing     effect on premature infants while in the neonatal intensive care unit (NICU). The primary     effect to be anticipated will be a reduction in heart rate from baseline, decreased motor     activity from baseline, as well as an increase of time in which the babies are in quiet sleep     states while the music is being played.      Upon admission, all infants in the NICU are placed on monitors that continuously track their     heart rate, respiratory rate, and oxygen saturation. During our study, data will be collected     from the monitors already in use. Total time of observation will be approximately 3 hours. In     addition, a monitoring device called an Actiwatch will also be used. This device looks     similar to a traditional wristwatch and will be loosely strapped to the ankle or wrist of     each infant using a foam and velcro strap. This device continuously monitors the baby's     movements allowing us to determine if there is a change in the baby's activity level while     the music is being played. It will record the baby's activity prior to the start of the music     and will continue until 30 minutes after the music has stopped.      The music of Mozart will be played using a small speaker in the baby's isolette. The volume     of the music will be set at 10 decibels over background noise, which on previous measurement     has been found to be approximately 55 decibels (about the same as a running refrigerator or     as the sound of rainfall; 60 decibels is the volume of normal conversation). The volume in     the crib will be continuously monitored throughout the hour. As a final recording device, we     will also intermittently be using video to capture the reactions of these infants to the     music. The study will be done once a week per infant on the same day and at the same time     every week   "
181838|NCT00224224|"     The goal of this study is to identify objective differences between primary care and     traditional medicine residents in clinical performance, continuity of care and utilization of     resources. Specifically, this retrospective study will analyze the database collected by     CLIMACS, the computer system at Cornell Internal Medicine Associates (CIMA). This system is     used for clinical and administrative purposes; it manages and tracks patient's information     and demographics, appointment booking, clinical diagnosis, prescriptions and medications,     laboratory and radiology test, and consults. In our study, we will analyze a subset of the     CLIMACS database from previous years.   "
181839|NCT00224237|"     This study will explore how culture influences the use of folk healing practices and medical     services in Latinos with chronic medical conditions.   "
181840|NCT00224250|"     Our hypothesis is that there is no difference in the healing process in those women who have     a one- or two-layer uterine closure at the time of cesarean delivery.   "
181841|NCT00224263|"     The purpose of this study is to determine whether Lingzhi (Ganoderma), a widely used     traditional Chinese Medicine is effective and safe in the treatment of Parkinson's disease     when combined use with L-dopa.   "
181842|NCT00224276|"     This pilot study hypothesizes that diagnosed and undiagnosed prevalence of diabetes mellitus     may differ across antipsychotioc medications in a community mental health center. The study     further hypothesizes that control of diabetes among diagnosed cases may be suboptimal.   "
181843|NCT00224289|"     Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it     is plausible that the age of a patient using the medication may affect its efficacy and time     of onset.      We are going to study the effectiveness of Latanoprost in people of different ages, to see if     it changes based on the age of the patient.   "
181844|NCT00224302|"     We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive     episodes during the course of psychotic disorders   "
181845|NCT00224315|"     We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a     randomized, prospective manner.   "
188866|NCT00328965|"     This study was designed to evaluate the anti-hypertensive efficacy of lacidipine in     hypertensives with Type 2 diabetes and effectiveness on endothelial cell function in Korean     population.   "
181846|NCT00224328|"     Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues     up to 2cm below the skin. It has been investigated, with success, in cerebral,     gastrointestinal, and muscle tissue, and shows promise in numerous indications involving     tissue ischemia. In the current study, we propose to examine one hundred patients requiring     either bypass or angioplasty due to chronic critical limb ischemia resulting from peripheral     arterial disease. We intend to challenge patients before and after the intervention, using     either an inflated blood pressure cuff or toe raises, to determine if oxygen saturation     recovery time in the affected limb is correlated with symptom resolution (i.e. treatment     success). Near-infrared spectroscopy will be performed using the ODISsey tissue oximeter     developed by ViOptix, Inc. The proposed study will take approximately one year to complete     enrolment, and has a follow-up period of 6 months post-intervention.      Study Hypothesis: Knowledge of tissue oxygen saturation enhances clinical decision making in     patients with chronic critical limb ischemia.   "
181847|NCT00224341|"     The objective of this trial is to show the therapeutic efficacy of the preventive pacing     therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial     fibrillation (AF). Two new algorithms (post-AF response and ventricular rate stabilization     [VRS]) will be assessed in a combined pathway, compared to a control group. The efficacy of     the overall available therapies to prevent AF and its symptoms will then be assessed also.   "
181863|NCT00226096|"     The purpose of the study is to determine whether lowering high blood pressure levels after     the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce     the chances of a person dying or surviving with a long term disability. The study will be     undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000     patients.   "
181848|NCT00224354|"     In the laboratory, we will put a special gene into cancer cells that have been taken from the     subject. This gene will make the cells produce interleukin 2 (IL-2), which may help the     patient's immune system kill cancer cells. Also, we will use CD40 ligand (CD40L) with the     IL-2. Studies of cancers in animals and in cancer cells that are grown in laboratories have     suggested adding the CD40L helps the IL-2 work better. Some of these new cells will then be     given back to the subject as a vaccine shot.      We believe that a part of the subject's immune system (cells called T-reg cells) might try to     kill off these special cells. If the T-reg cells do that, the vaccine would not work as well     or last as long. To try to avoid this, before the special cells are put back into the     subject's body, we will give them an intravenous (IV) dose of IL-2 immunotoxin (called     denileuk diftitox or ONTAK). ONTAK should get rid of some of the T-reg cells in the subject's     body which should help the special cells work better and longer.      The purpose of this study is to learn the safety and cancer-fighting effects of using IL-2     with the vaccine.   "
181849|NCT00224367|"     Hip fractures are a significant problem for healthcare providers due to the increasing     incidence of fractures in an ageing population. Hip fracture is the most frequent fracture     for people over 80 years of age and the second most frequent for those over 65 years. It is     projected that by 2051, 23% of the Australian population will be older than 65 and the number     of hip fractures will rise fourfold (17,000 in 2004, to 60,000 in 2051).      Evidence-based clinical practice guidelines regarding management of hip fracture were     published in the Medical Journal of Australia in 1999 and updated in 2003. Seventeen aspects     of treatment were systematically reviewed, including mobilisation after surgery. Early     assisted ambulation within 48 hours post surgery was recommended (Chilov 2003 p 490).     However, the recommendation was based on observational (level 3) evidence only.      Early mobilization post surgery is resource intensive. Early mobilization is challenging and     uncomfortable for the patient and requires the assistance of one or sometimes two,     physiotherapists available seven days per week. Benefits must be rigorously evaluated to     justify recommendation. We undertook a randomized controlled trial of the effect of two     different ‘time to first ambulation’ intervals after hip fracture surgery on patient and     hospital outcomes.Our hypothesis was that early mobilisation would accelerate functional     recovery after hip fracture surgery.   "
181850|NCT00224380|"     The goal of this pilot study is to learn about how well older people with serious mental     illness (including schizophrenia, schizoaffective disorder, bipolar disorder, major     depression) follow prescribed medication regimens, and to evaluate a manualized intervention     designed to enhance medication management skills and adherence, the Using Medications     Effectively program. The following four hypotheses will be tested:        1. Medication adherence will be associated with several variables including insight,          memory, medication management skill, knowledge about medications, attitudes about          medications.        2. People who receive the program will have better medication adherence compared to those          who do not receive the program as measured by pill counts.        3. People who receive the program will develop better medication management skills compared          to those who do not receive the program.   "
181851|NCT00224393|"     The purpose of this study is to evaluate the efficacy of Enbrel in patients with primary     systemic Amyloidosis.   "
181852|NCT00224406|"     The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear     neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Repertaxin     is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and     efficacy of repertaxin in preventing the primary graft dysfunction (PGD) after lung     transplantation.   "
181853|NCT00224419|"     Nicotine dependence has not been sufficiently addressed in current state-of-the-science     cessation interventions for pregnant smokers. The weight of the evidence from the general     population of smokers suggests that nicotine replacement therapies may be beneficial     cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential     of these therapies for promoting smoking cessation among pregnant women creates a pressing     need for decision tools and protocols to encourage treatment adherence that is essential for     rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care.     The results of this research could be directly translated to the improvement of obstetrical     care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers     is an alternative to continued smoking that has the potential to substantially increase rates     of smoking cessation during pregnancy.   "
181854|NCT00224432|"     To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on     clinical and immunological parameters in infants with AD with and without CMA and to compare     effectiveness of different strains of probiotics.   "
181855|NCT00224445|"     To determine the safety and efficacy of a simple, once-daily antiretroviral (ARV) regimen     consisting of a fixed-dose combination tablet containing Truvada combined with atazanavir     boosted with ritonavir in treatment naive patients.   "
181858|NCT00226031|"     To evaluate the effectiveness of a multifaceted intervention (reminder and educational     material) in improving the evaluation of osteoporosis follow-up care of post-menopausal women     with wrist fractures by their primary care physicians. The intervention is directed at     improving the gap in continuity of care between emergency/fracture clinics and family     physicians, and reducing knowledge gaps.   "
181859|NCT00226044|"     The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment     in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic     hernia.   "
181860|NCT00226057|"     The purpose of this study is to determine if Raptiva will have beneficial effects in the     treatment of patients with moderate to severe atopic dermatitis.   "
181861|NCT00226070|"     Patients over 65 years do not have a self care ability the surgery benefits them.      The aim of this study is development of a rehabilitation program based on patients'     self-rated health.        1. A cross section study including 600 patients        2. RCT including 160 patients   "
181862|NCT00226083|"     We are studying if sickle cell disease blood platelets are larger than normal and how they     may cause obstruction of blood vessels. We are also trying to study the reasons why large     platelets are found in patients with sickle cell disease.   "
181960|NCT00227357|"     The goal of this study is to develop and evaluate an innovative model of care to better serve     patients who are both HIV-infected and opioid-dependent.   "
181864|NCT00226109|"     Chronic alcoholics suffer from weak skeletal and cardiac muscle. The investigators have     discovered a beneficial effect of spironolactone-treatment in that regard. Therefore, a     double blind placebo controlled study is conducted, to examine the effects of spironolactone     on cardiac and skeletal muscle-function in chronic alcoholics.   "
181865|NCT00226122|"     Monosymptomatic nocturnal enuresis, defined as the involuntary loss of urine during the night     at an age where voluntary bladder control should have been attained and on the background of     normal urinary tract function, is a rather common disease of childhood with an estimated     prevalence of 5-10% at tha age of 7 and a spontaneous remission rate of 15% per year.      The present study consists of two phases; an in-patient phase and an ambulatory phase.      In the in-patient phase we will examine the regulation of sodium and the circadian rhythm of     the hormones that affect this regulation in children with enuresis nocturnal and healthy     children, as well as the impact of indomethacin on renal water and electrolyte excretion.      In the ambulatory phase we will examine the efficacy and safety of a treatment modality     consisting of a combination of dDAVP and indomethacin in patients with severe enuresis where     dDAVP as monotherapy is inadequate.      A significant number of children with enuresis and nocturnal polyuria do not respond to     treatment with dDAVP. If a combination treatment with dDAVP and indomethacin proves superior     to dDAVP alone the regimen could readily be used in those difficult to cure cases of     enuresis.   "
181866|NCT00226135|"     The purpose of this study is to compare lamotrigine with lithium in the long term treatment     of bipolar disorder in terms of new episode preventive potentials.   "
181867|NCT00226148|"     The purpose of this study is to look at the bonehealing when a molar has been extracted and     immediately replaced by an implant leaving some defects around the implant.      The defects are being treated in three different with the hypothesis that the three ways of     treatment result in equal bonehealing.   "
181868|NCT00226161|"     The purpose of this study is to determine whether laparoscopic inguinal hernia repair leads     to a lower incidence of chronic pain compared to open herniorrhaphy.   "
181869|NCT00226174|"     The purpose of this study is to determine whether curcuminoids are effective in the treatment     of oral lichen planus.   "
181870|NCT00226187|"     A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in     breast-fed preterm infants      Background:      Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Human     milk and preterm formulas contain DHA and AA, but at lower concentrations than required to     approximate utero accretion rate.      Objective:      To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in     the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age.      Design:      A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal     centers.      Subjects and methods:      Infants with birth weight < 1.5 kg are randomized to either an intervention or a control     group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per 100     ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid, Martek,     USA), while the control oil contains vegetable oil without DHA or AA. Blood samples are     collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed for     fatty acid pattern using high performance liquid chromatography.   "
181871|NCT00226200|"     This study involves a FDA approved drug, Omalizumab, used in the treatment of moderate to     severe allergic asthma that cannot be controlled by standard treatment. It works on IgE to     control the allergic reaction. We are looking at the effects on non-allergic asthma. We hope     to prove that Omalizumab will have the same effect on non-allergic asthmatics as it does     allergic asthmatics.   "
181872|NCT00226213|"     The purpose of the study is to perform the first clinical trial on human subjects using the     Sonic Flashlight (SF) to guide placement of Peripherally Inserted Central Catheters (PICCs).   "
181873|NCT00226226|"     The purpose of this study is to test whether peripherally inserted central catheters can be     safely placed on patients by intravenous team nurses at the bedside.   "
181874|NCT00226239|"     The purpose of this study is to determine if the addition of a unique targeted agent called     Cetuximab (also known as C225 and Erbitux) can increase the effectiveness of standard     treatment with chemotherapy and radiation.   "
181875|NCT00226252|"     The purpose of this research study is to investigate a manual wheelchair training program to     improve the way manual wheelchair users push their wheelchairs.   "
181876|NCT00226265|"     The purpose of this study is to determine whether the SF-36 can be administered reliably to     cardiac surgery patients (two to three days) post-surgery, with the patient answering the     questions of this survey from a pre-surgical perspective.   "
181877|NCT00226278|"     Patients suffering from Major Depressive Disorder with Psychotic features who have received     no changes in their medications in the previous two weeks will receive usual treatment of     antidepressants, antipsychotics and/or mood stabilizers and adjunct therapy using ORG34517.     The patient will be hospitalized for up to two weeks to monitor their medications and     progress and will return to the site for periodic assessments.   "
181878|NCT00226291|"     This study is investigating the effects of an established clinical informationist program     (evidence-based practice support service in which information professionals with significant     clinical knowledge bases and advanced information seeking and appraisal skills) on clinical     decision making at selected critical care units at Vanderbilt University Medical Center   "
181879|NCT00226304|"     This study will evaluate the usefulness of two tests in quickly distinguishing whether a     patient with HIV infection and focal brain lesions (an injury in a specific area of the     brain) has a rare type of cancer called primary central nervous system lymphoma (PCNSL), or a     parasitic infection called toxoplasmic encephalitis.      Toxoplasmic encephalitis is caused by a parasite and can be treated with antibiotics. PCNSL     (lymphoma of the brain or spinal cord) must be definitively diagnosed with a brain biopsy     (removal of a small piece of brain tissue), and the treatment is radiation therapy and     chemotherapy.      The tests under study for diagnosing PCNSL or toxoplasmic encephalitis are measurement of     Epstein Barr virus (EBV) DNA in cerebrospinal fluid (CSF) and FDG-PET scan of the brain. EBV     is often found in the CSF of people with PCNSL. The study also will compare the accuracy of     two imaging techniques-TI-SPECT and FDG-PET-in distinguishing between toxoplasmosis and     PCNSL.      Patients 18 years of age and older who have HIV infection and at least one focal brain lesion     without a prior history of PCNSL or toxoplasmic encephalitis may be eligible for this study.     Each candidate is screened with a medical history, physical examination, blood and urine     tests and MRI scans of the brain.      Upon entering the study, all participants take medication to treat toxoplasmic encephalitis.     They undergo lumbar puncture (spinal tap) to obtain CSF for analysis, an FDG-PET scan, and a     201TI-SPECT scan. For the PET scan, a radioactive substance is injected into an arm, followed     by scanning in a doughnut-shaped machine similar to a CT scanner. SPECT is similar to PET but     uses a different radioactive tracer, and the patient lies on a table while the SPECT camera     rotates around the patient's head. Patients whose test results indicate a low risk for     lymphoma continue antibiotic therapy for toxoplasmosis. They have repeat MRI scans around 4,     7, and 14 days after starting the drug to monitor the response to therapy. Antiretroviral     therapy is initiated in patients who are not already on such a regimen.      Patients whose test results indicate a high risk for PCNSL have a CT scan to look for     evidence of lymphoma elsewhere in the body and are referred for consultation with a     neurosurgeon to discuss undergoing a brain biopsy. The brain biopsy is done in the operating     room under general anesthesia. A small cut is made in the scalp and a small opening is made     in the skull over the area of the brain to be biopsied. A needle is placed in the opening in     the skull and, guided by CT or MRI, moved to the abnormal area of the brain, where a small     piece of tissue is removed for study under a microscope.      Patients found to have toxoplasmosis are discharged from the hospital to the care of their     primary care physician after they are getting better and are tolerating all their     medications. They return to NIH for follow-up visits about 4 weeks, and 6 months after     discharge.      Patients found to have lymphoma are referred to the National Cancer Institute for screening     for enrollment in a treatment protocol. Patients who are not eligible for a treatment     protocol are referred back to their primary care physician or for another NIH treatment     protocol, if one is available. Patients with lymphoma are seen at the NIAID outpatient clinic     for follow-up visits and laboratory examinations every 3 months for 2 years.   "
181880|NCT00226317|"     A systematic open-label prospective pilot study to assess aripirazole for acute bipolar     depression, with a secondary assessment of longer-term mood stabilization.   "
181881|NCT00226330|"     This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to     monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in     patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including     treatment and follow-up, is 107 weeks.   "
181882|NCT00226343|"     Obtain information using a randomized treatment to assess the antidepressant and anxiolytic     efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive     episodes.   "
181883|NCT00226356|"     This study is being conducted to determine the clinical response rate for the regimen of     L-methionine, betaine and folate for unipolar depression.   "
181884|NCT00226369|"     We conducted a multicenter, randomized, placebo-controlled trial of Cylexin, an inhibitor of     the attachment of white blood cells to the endothelium. Our study population was neonates and     infants undergoing hypothermic cardiopulmonary bypass during surgical repair or palliation of     congenital heart defects.   "
181885|NCT00226382|"     This study is to investigate the HBV DNA suppression (and HBeAg seroconversion among HBeAg     positive patients) pegylated interferon treatment at 24 weeks after end of treatment among     patients who have failed anti-viral treatment in the past.   "
181886|NCT00226395|"     The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of     oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.   "
181887|NCT00226408|"     The study protocol is being conducted to compare intermittent high-dose i.v. administation of     interferon alpha-2b with the standard high-dose treatment by Kirkwood with distant metastasis     free survival (DMFI) as a primary endpoint.   "
181888|NCT00226421|"     The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone     extended release in opioid-experienced patients with chronic low back pain.   "
181889|NCT00226434|"     In Cambodia the prevalence of both tuberculosis (TB) and Human Immunodeficiency Virus (HIV)     infection is high. Data suggest that aggressive management of HIV infection, which includes     Anti-Retroviral Therapy (HAART) during treatment of TB, decreases both morbidity and     mortality. On the other hand, the use of HAART for patients with TB may cause severe     complications due to drug-drug interactions, and occasionally a temporary exacerbation of     symptoms. These reactions may be particularly severe when HAART is started soon after the     start of TB treatment.      The proposed study aims to determine the optimal time to initiate HAART in previously     untreated HIV-infected adult patients with TB and low CD4 cell counts.   "
181890|NCT00226447|"     The aim is to investigate the best treatment regime of PEG-Intron A and lamivudine     combination in terms of viral clearance in chronic hepatitis B patients.   "
181891|NCT00226460|"     The purpose of this study was to evaluate the differences in safety and efficacy between     Parkinson's disease patients who either received transplantation of fetal porcine cells or     placebo treatment.   "
181892|NCT00226473|"     The purpose of this multicenter study is to examine whether the proposed randomized treatment     regime results in a significantly longer survival time and higher quality of life than any     additionally applied multiple chemotherapy according to the CVD- scheme. So far neither     established treatment regimes nor reliable data exist for the second-line chemotherapy of     metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple     chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not     only a higher toxicity but show rarely a response rate higher than 10%.   "
181893|NCT00226486|"     Falls and injurious falls are common among elderly people. The aim of the study is to test a     model of multifactorial fall intervention in a Danish population of elderly sustaining a     fall. Focus is on prevention of further falls, patients views on fall prevention and a     cost-effectiveness analysis.   "
181894|NCT00226499|"     An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella     vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in     the prevention of varicella disease in children. The Protocol Posting has been updated in     order to comply with the FDA Amendment Act, Sep 2007.   "
181895|NCT00226512|"     Multi-institutional randomized phase III trial of a non-myeloablative preparative regimen     with fludarabine and busulfex with or without anti-lymphocyte antibodies (monoclonal     humanized Campath-1H administered s.c. or polyclonal rabbit anti-T lymphocyte antibodies     (ATG), combined with low dose and short course cyclosporine A (CSA) and methotrexate (MTX) as     the sole agent for prevention of graft-vs-host disease (GVHD) for patients with acute     myelogenous leukemia or myelodysplastic syndrome undergoing allogeneic stem cell     transplantation from an HLA compatible donor.   "
181896|NCT00226525|"     This trial is intended to find wether there is a connection between allergy to metals and     reooclusion of stents in the coronary arteries   "
181906|NCT00226655|"     The purpose of this study is to examine the long-term safety and tolerability of human     corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone     (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to     all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other     designated studies, including patients who may have discontinued blinded study medication     early but completed the protocol-stipulated follow-up periods.   "
181897|NCT00226538|"     CYP2C9, is one of the major drug metabolism enzymes accounting for about 20% of the hepatic     cytochrome P450 content and being second only to CYP3A4.      The proposed study will explore different possible drug interactions with CYP2C9 substrates     by evaluating the effect of prototype inducers and inhibitors on the phenotypic trait     measurement. It is expected that the identification of drugs that might interact with CYP2C9     substrates will be used to rationalize future drug interaction studies designed to evaluate     the actual magnitude of effect and its clinical implications. This approach should be     particularly useful when applied to those CYP2C9 drugs characterized by a narrow therapeutic     index (i.e. warfarin).      This study will consist of three study periods separated from each other by a two weeks     washout period. In the course of the study the subjects will receive in a double blind,     crossover fashion, rifampin 300 mg. twice daily, diclofenac 50 mg twice daily. and     fluconazole 200 mg. twice daily, each for one week. All drugs will be administered as     identical looking tablets that will be prepared at the pharmacy of the Hadassah University     Hospital and their order of administration will be randomized.On the day prior to, on day 6     of and 7 days following each drug period, the activity of CYP2C9 will be evaluated by the     administration of a single phenytoin 300 mg. dose. The subjects will be requested to collect     their urine for 24 hours and a single blood sample will be obtained 12 hours post phenytoin     intake.   "
181961|NCT00227370|"     The study evaluated the efficacy and safety of a prolonged, continuous course of     Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the     standard of care upon initiation of the study, to 12 months of Valganciclovir.   "
182060|NCT00219284|"     To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with     end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and     entacapone.   "
181898|NCT00226551|"     Single nucleotide polymorphisms at codon 46 and 79 of the gene encoding for the ß2 adrenergic     receptor (ß2AR) modify its pharmacological properties and may alter the response to ß2AR     agonists. The goal of the present study was to evaluate the role played by the Arg16Gly and     Gln27Glu polymorphisms on isoproterenol induced relaxation of internal mammary arteries     segments ex-vivo.      Internal mammary leftover segments were collected from 96 patients undergoing coronary artery     bypass graft operation. Four rings that were prepared from each specimen were allowed to     reach equilibrium with physiological Krebs solution prior to precontraction with U46619.     Using the organ bath technique, cumulative dose response curve of isoproterenol was     constructed and mean EC50 calculated for each patient.   "
181899|NCT00226564|"     The response to opioids varies greatly among individuals. Some of these variability is     accounted for by genetic factors.      The present study was designed to evaluate the possibility that genetic polymorphism in the     gene encoding for mu opioid receptor may explain variability in the response to alfentanil     during lithotripsy.   "
181900|NCT00226577|"     This study will evaluate the efficacy and safety of chemotherapy given prior to having lung     cancer surgically removed. Patients with resectable non-small cell lung cancer will receive     gemcitabine and pemetrexed together for 4 times biweekly. Patients will be seen by a medical     oncologist prior to each cycle of chemotherapy given. The medical oncologist will review     patient's bloodwork and symptoms prior to approving next cycle of chemotherapy. All patients     will then be evaluated with scans to determine response to chemotherapy and to determine if     patient is a surgical candidate. These patients will then proceed to surgery to have the lung     cancer removed. Follow up visits include bloodwork, scans, and a visit with the medical     oncologist every three months for two years, then every six months for three years to monitor     for disease recurrence.   "
181901|NCT00226590|"     This is a single institution Phase II study for patients with unresectable Stage IIIA and     IIIB non-small cell lung cancer. The treatment started with 2 cycles of gemcitabine and     carboplatin followed by concurrent chemotherapy with radiation. The chemoradiation included     using paclitaxel and carboplatin with daily thoracic radiation to a total dose of 74 Gy.     Response rate was determined following the chemotherapy with gemcitabine and carboplatin and     evaluated again after the chemoradiation. Treatment toxicities were also assessed.   "
181902|NCT00226603|"     To examine the effect of a specific training programme towards groin injuries in male footbal     players. To evaluate the effect on other football related injuries as well. To examine any     possible relations between various possible predictors such as experience, age, hypermobility     and others, and the risk of sustaining inujries during football.   "
181903|NCT00226616|"     Cholera is one of the leading causes of morbidity and mortality among children and adult in     developing countries. We will evaluate the effect of supplementation of zinc on reduction of     duration and severity of cholera. Since cholera is primarily a disease of older children and     adults, we intend to study the effects of zinc supplementation among children of 3 to 14     years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field     examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea     for less than 24 hours will be selected. After inclusion in the study, informed consent will     be obtained from guardian explaining the full procedure in the hospital. The subjects will be     randomized to receive either zinc or placebo until diarrhea resolves. History of illness and     baseline information will be collected in the hospital through interview, which may take     duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be     carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample     will be taken to assess serum zinc level on admission after initial hydration and will be     repeated on the day of recovery. This procedure carries a small risk of infection if not done     under sanitary conditions; however, we will maintain proper sanitation, so there is no risk     in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given     daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet     Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous     acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be     sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of     random stool samples. Information obtained from history and the laboratory investigations of     subject will be kept strictly confidential and no one other than the investigators of this     study and the Ethics Committee of this Centre will/ has access to the information. The study     will benefit the patients as study physician will do close observation, examination and will     take care frequently, as research staff will monitor systematic progress and take necessary     action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If     the results of the study is positive, it will benefit the patients in their treatment during     this study and thereafter. The data will be analyzed for clinical effects of zinc on     diarrhea.The study will help to improve the treatment strategy of cholera in children. The     study will use hospital records, which will be returned after completion of the study. Stool,     urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.   "
181904|NCT00226629|"     The purpose of this study is to compare the cost effectiveness, quality of life and outcomes     of the endovascular stent graft repair with the open surgical repair of abdominal aortic     aneurysms.   "
181905|NCT00226642|"     The purpose of this study is to determine the efficacy of a SSRI,     cognitive-bahavioral-therapy and a free choice between SSRI and CBT in a sample of primary     care patients suffering from mild to moderate depression.      Hypotheses:        -  SSRI is superior to placebo        -  CBT is superior to a non-specific supporting group therapy   "
181907|NCT00226668|"     The purpose of this study is to examine the safety and efficacy of XERECEPT (human     Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary     malignant glioma who require increased dexamethasone doses to control symptom of peritumoral     brain edema.   "
181909|NCT00226694|"     The purpose of this study is to look at the stress hormone response to medication-induced     stress and a placebo (an inactive compound) in non-drinking, recovering male and female     alcoholics, with a specific emphasis on the differences between men and women in the two     recovering alcoholic groups.   "
181910|NCT00226707|"     Topical steroids are standard of care for Chronic Hand Dermatitis, but long-term use is     associated with adverse effects. This study will assess the efficacy and safety of     pimecrolimus cream 1% in patients with mild-to-moderate chronic hand dermatitis.   "
181911|NCT00226720|"     Detoxification, in an inpatient or outpatient program, is the primary and essential step for     managing alcohol dependence. The superiority of one or other method of detoxification has     never been proved in several previous randomized clinical trials (RCT). The aim of this     multicenter RCT was to compare efficiency, on the abstinence rate as the primary outcome, at     1 and 3 months follow-up of two alcohol detoxification programs (a 5/7-days inpatient detox     vs. an ambulatory detox).   "
181962|NCT00227383|"     In this study, we aim at evaluating the effect of electroacupuncture in diabetic patients     with gastroparesis. Patient-based symptom severity measure, serum parameters and solid-phase     gastric emptying time are measured to evaluate the effectiveness of electroacupuncture.   "
182112|NCT00219960|"     To determine the effect of North American ginseng on blood pressure in individuals with     hypertension.   "
181912|NCT00226733|"     The purpose of this study is to investigate the effect of high and moderate intensity     exercise training after coronary bypass surgery. The subjects are randomised to training at     either 60-70% or 85-95% of their maximal capacity daily for four weeks. Primary outcome     measure is change in maximal aerobic capacity, measured as change in maximal oxygen     consumption, after the training period. Secondary outcome measures are change in quality of     life, heart rate variability, ultrasound measures of the heart and blood variables, including     endothelian markers.   "
181913|NCT00226746|"     The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs     gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation     treatment on locally advanced pancreatic cancer.   "
181914|NCT00226759|"     The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic     surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma     initiates an acute inflammatory response, including swelling and pain, that leads to     restricted joint motion and loss of function. OMS103HP was designed to deliver targeted     therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit     inflammation and pain before they can begin.      The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving     knee function following ACL reconstruction. Secondary benefits being evaluated include     reduced postoperative pain, improvement in knee range of motion and earlier return to work.   "
181915|NCT00226772|"     The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic     surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma     initiates an acute inflammatory response, including swelling and pain, that leads to     restricted joint motion and loss of function. OMS103HP was designed to deliver targeted     therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit     inflammation and pain before they can begin.      The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving     knee function following ACL reconstruction using a hamstring autograft. Secondary benefits     being evaluated include reduced postoperative pain, improvement in knee range of motion, and     earlier return to work.   "
181916|NCT00226785|"     The study aims to demonstrate that dexmedetomidine is non-inferior to current best practice     sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of     sedation in long-stay intensive care unit (ICU) patients, and that dexmedetomidine, compared     with current best practice, reduces the length of ICU stay.   "
181917|NCT00226798|"     Immunochemotherapy consisting of IL-2, INF-A, and VBL and 5FU is regarded as the treatment of     choice in metastatic renal cell carcinoma. During the period 1996-2000, we evaluated the     efficacy and toxicity of this immunochemotherapy, combined with an aggressive surgical     approach: nephrectomy before treatment and resection of residual disease. The 3-year survival     rate for the entire group and complete responder patients was 30% and 88%, respectively. The     side effects were usually moderate and consisted mainly of a flu-like syndrome, headache,     nausea, vomiting and depression. Most importantly, there was no drug-related death. Good     performance status, absence of bone metastases and prior nephrectomy were associated with     higher response rates.      Capecitabine is a novel fluoropyrimidine carbamate, orally administered and selectively     activated to Fluorouracil by a sequential triple-enzyme pathway in liver and tumor cells.     Capecitabine at dose of 2,500mg/m2/d divided equally into two daily doses for 14 days in     patients who failed to respond to “standard” immunotherapy achieved a 30% objective response.     Toxicity consisted of hand-foot syndrome.      Aim of Study:      To evaluate efficacy and toxicity of the combination of IL-2, INF-A, VBL and Capecitabine in     MRCC   "
181918|NCT00226811|"     The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2     step design) after which Step 2 was opened and the total enrollment target for the study     (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study     did not open due to the final overall insufficiency of efficacy observed in 78 patients.     Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a     starting dose of 50 mg with provision for dose reduction based on tolerability. All patients     received repeated cycles of sunitinib until disease progression, occurrence of unacceptable     toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients     were followed up in order to collect information on further antineoplastic therapy and     survival.   "
181919|NCT00226824|"     The purpose of this study is to determine the safety, tolerability and efficacy of     galantamine in tic disorders. The impact of galantamine on commonly associated behaviors     (i.e. attention, obsessions, etc.) will also be examined.   "
181920|NCT00226837|"     Our hypothesis is that a new method of depth of anaesthesia monitoring, using theoretically     based time series modelling will result in improved ability to determine nitrous oxide     anaesthetic effect   "
181921|NCT00226850|"     This study examined whether a hypnosis intervention, compared to standard care, could help     reduce distress and pain for children undergoing an invasive medical procedure.   "
181922|NCT00226863|"     This study examined whether meditation or group psychotherapy including hypnosis plus     education, compared to an educational control, would ameliorate long-term depressed mood.   "
183162|NCT00240851|"     The purpose of this study is to compare the effectiveness of acetaminophen extended release     caplets to placebo in treating the muscle aching and pain (soreness) that occurs after a     marathon.   "
181923|NCT00226876|"     Patients commonly report that they have been dreaming when they awaken from general     anaesthesia. Our hypothesis is that patients who report dreaming are less deeply     anaesthetised during anaesthesia than patients who do not report dreaming. Depth of     anaesthesia will be determined using a processed electroencephalographic monitor (called the     BIS monitor).   "
181924|NCT00226889|"     Systemic sclerosis (ssc) is characterised by extensive tissue fibrosis. Using drugs that are     capable of inhibiting fibroblast activity may be beneficial if administrered early in the     disease course. Thirty adult patients with early SSc will be treated with the endothelin-1     antagonist bosentan for 6 months.Disease progression will be assessed.   "
182032|NCT00228384|"     To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol     stent for the treatment of superficial femoral artery (SFA) occlusive disease in long     lesions.   "
181925|NCT00226902|"     Dialysis patients suffer from many problems with blood vessels and this is even more so for     patients with the added complication of diabetes. Diabetics have a number of reasons for     vascular disease and one of the new areas of research is looking at the cells that line the     blood vessels, called endothelial cells. It is thought that the number of red blood cells in     the blood (haemoglobin concentration) affects the function of these cells. There is very     little information available on what haemoglobin level is best for dialysis patients. As     diabetics account for almost 40% of dialysis patients worldwide it is important to understand     the effect different haemoglobin levels will have on the blood vessels.      Hypothesis: Endothelial cell function and the related expansile capacity of blood vessels are     affected by different haemoglobin concentrations [Hb] in dialysis patients.   "
181926|NCT00226915|"     The purpose of the study is to compare progression-free survival of conventional paclitaxel     and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage     II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.   "
181927|NCT00226928|"     This study will investigate the influence of psychosocial treatment on psychological outcomes     and survival among women with metastatic or recurrent breast cancer.   "
181928|NCT00226941|"     1. To determine the MTD and DLTs of oxaliplatin and capecitabine when combined with C225          and radiotherapy (Phase I)        2. To determine the pathologic response rate of C225 in combination with this neoadjuvant          cytotoxic regimen (Phase II)   "
181929|NCT00226954|"     Primary:      To determine the duration of use of zoledronic acid in improving Bone mineral density in     patients with prostate cancer who are on hormones intermittently.      Secondary Objectives:      To describe the safety and tolerability at this dose and schedule   "
181930|NCT00226967|"     The purpose of this study is to learn about the effects of stress on hormones, the     relationship between these hormones and cancer progression.   "
181931|NCT00226980|"     The purpose of this study is to determine the efficacy of the combination of thalidomide and     capecitabine in metastatic renal cell carcinoma and also to determine the safety of the     combination.   "
181932|NCT00226993|"     This is a single institution phase I / II trial to evaluate the safety and efficacy of     intratumoral CpG injections combined with local radiation in patients with mycosis fungoides.     Patients will receive low-dose radiotherapy to a single tumor site on days 1 and 2 (2 Gy each     day). CpG injections will be administered into the same tumor site within 24 hours before or     24 hours after each radiation treatment. Weekly doses of (intratumoral or peritumoral     injections) CpG will be then administered subcutaneously in the region of previous injections     for 23 additional doses. The total treatment duration is 24 weeks.   "
181933|NCT00227006|"     Once intervention class or staff contact is removed, obese adults participating in behavioral     weight-loss programs often give up healthy eating habits and regain weight. We examined     whether taste-based goal setting, which minimizes perceived deprivation by promoting taste     and moderation, would sustain long-term reductions in saturated fat and body mass index     (BMI).   "
181934|NCT00227019|"     This trial evaluated the safety of combining bevacizumab and pemetrexed in non-small cell     lung cancer (NSCLC) patients with stable brain metastases as second-line chemotherapy, while     evaluating progression-free survival (PFS) and overall survival (OS).   "
181935|NCT00227032|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib in     treating patients with progressive glioblastoma multiforme.   "
181936|NCT00227045|"     The objective of this study is to determine the extent and magnitude of the pharmacokinetic     drug interaction between mycophenolate mofetil (MFF) (under Css conditions) in the presence     of iron in renal transplant recipients.      A two phase pharmacokinetic study will be conducted to determine the bioavailability of MMF     (under steady state, Css, conditions) in the presence of two commonly prescribed iron     formulations (polysaccharide iron complex and sustained release ferrous sulfate) in renal     transplant recipients. This study will evaluate valuable clinical information to help better     guide the appropriate utilization of the following formulations and dosing strategies:        1. Polysaccharide iron complex concomitant administration with MMF,        2. Sustained release ferrous sulfate concomitant administration with MMF,        3. Dose separation (2 hours) between MMF and iron (polysaccharide iron complex or sustained          release [S.R.] ferrous sulfate)   "
181937|NCT00227058|"     The purpose of this study is to learn if two nutritional supplements, Orotic Acid and     Glutathione will have any effect on the immune system response and if there will be any     effect on the symptoms of seasonal allergies. It is our thinking that they will have an     positive effect.   "
181938|NCT00227071|"     Compare the effect of aquatic,land and no exercise on fall risk factors in women diagnosed     with osteoporosis   "
181939|NCT00227084|"     To evaluate whether Arista AH which contains microporous polysaccharides used as a powder     applied to the wound area during mammary surgery reduces the amount of bleeding and the     duration of surgery. Both mammae are operated on in the same procedure, and one side without     Arista serves as control side   "
181940|NCT00227097|"     The objective of the project Educ'Avk, is to document the efficacy of a strategy combining     a specific follow up-notebook and education of attending patient with a pedagogic support,     comparatively to an usual education on the impact of clinical events at three months (minor     or major hemorrhagic events + recurrence of thrombi-embolic's disease).   "
181941|NCT00227110|"     To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH)     in patients with glucose intolerance or type 2 diabetes mellitus (T2DM).   "
181943|NCT00227136|"     This is a research study looking at the effect of 5-Hydroxy Tryptophan (5-HTP) on urine     excretion of 5-Hydroxyindolacetic acid (5-HIAA). 5-HTP is a common over the counter product     that is sold in natural food stores and via the Internet. Increased levels of 5-HIAA in the     urine can be found in a specific type of cancer, called carcinoid tumor. This study will     examine the effect of oral 5-HTP intake on 5-HIAA excretion. Understanding this effect may     help to determine which tests should be done in a patient with increased 5-HIAA excretion     who’s also taking 5-HTP.   "
182033|NCT00228397|"     To evaluate the safety and tolerability of long-term therapy with 3 dose levels of oral     CCI-779 administered to subjects with relapsing MS who completed study 3066A2-205-WW.   "
181944|NCT00227149|"     This is a long-term evaluation follow-up study of neurocognitive performance and emotional     state in patients with chronic hepatitis C infection and a former (peg)interferon     alfa-2b-based therapy.      M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen      Questions:        -  Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients          with chronic hepatitis C - are they fully reversible in long-term follow-up after the          end of antiviral treatment?        -  At least 12 months after the end of antiviral treatment - are neurocognitive and          mood-related parameters even significantly improved as compared to pretreatment values?          Is this possibly only true of patients with successful virus eradication?        -  At least 12 months after the end of antiviral treatment, is there a significant          difference between patients with and without sustained virological response with respect          to neurocognitive performance, emotional state and quality of life?        -  In the absence of clinically significant liver damage in patients with chronic hepatitis          C - does the mere presence of the hepatitis C virus have any significant influence on          neurocognitive or attentional performance?        -  Does the study data support an additional indication for antiviral therapy in chronic          hepatitis C? In the case of successful virus eradication, emotional state and - above          all - is neurocognitive performance significantly improved even in the absence of severe          liver damage?   "
181945|NCT00227162|"     The objective of this pilot study is to assess the feasibility and the potential differential     impact of a novel intervention of induced positive affect and self-affirmation to increase     physical activity in asthma patients.   "
181946|NCT00227175|"     To explore the meaning, causes and treatment of hypertension in eligible patients. In     addition the cultural, social, and psychological factors that either facilitate or serve, as     barriers to behavioral change will be illuminated in this patient population.   "
181947|NCT00227188|"     The aim of this study is to evaluate the postlicensure effectiveness of Prevnar in the     prevention of IPD in the Spanish paediatric population (children younger than 5 years)   "
181948|NCT00227201|"     The objective of this study is to better understand strategies used by African Americans with     hypertension in order to control their blood pressure.   "
181949|NCT00227214|"     The aim of this study is to determine the prevalence of pneumococcal meningitis in the     paediatric population in Spain four years after the marketing of Prevenar. Also secondary     objectives are: 1) to determine the clinical characteristics and outcome of the disease; and     2) to determine serotypes and antibiotic resistance patterns.   "
181950|NCT00227227|"     The purpose of this study is to investigate the incidence of adverse events for patients with     AS treated with Enbrel in usual care settings.   "
181951|NCT00227240|"     The purpose of this study is to investigate the incidences of adverse events for patients     with plaque psoriasis treated with Enbrel under usual care settings.   "
181952|NCT00227253|"     Our vision, that of the researchers at the University of Texas Health Science Center at San     Antonio, is that every person with a chromosome 18 abnormality will have an autonomous and     healthy life. Our mission is to provide families affected by chromosome 18 abnormalities with     comprehensive medical and educational information. Our goals are to provide definitive     medical and education resources for the families of individuals with chromosome 18     abnormalities; perform and facilitate groundbreaking clinical and basic research relating to     the syndromes of chromosome 18; and to provide treatments to help these individuals overcome     the effects of their chromosome abnormality.   "
181953|NCT00227266|"     This is a multi-center trial to assess safety and efficacy of a combined regimen of oral     valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17     years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat     protocol for SMA sitters 2 - 8 years of age. Cohort 2 is an open label protocol for SMA     standers and walkers 3 - 17 years of age to explore responsiveness of efficacy outcomes.     Outcome measures will include blood chemistries, functional testing, pulmonary function     testing, electrophysiological evaluations, PedsQL quality of life assessment, quantitative     assessments of survival motor neuron (SMN) mRNA from blood samples, growth and vital sign     parameters. Six centers will enroll a total of 90 patients.   "
181954|NCT00227279|"     This trial is performed to assess the efficacy and safety of the ALK Grass tablet for     treatment of grass pollen induced rhinoconjunctivitis (hayfever).   "
181955|NCT00227292|"     Chronic low back pain (CLBP) is one of the most frequent forms of chronic pain and can result     in significant functional impairment. This is often associated with major depression too.     Previous research reported significant beneficial effects of antidepressant medication in     alleviating depression and pain intensity. The aim of this study is to evaluate the efficacy     of Escitalopram, a new kind of Selective Serotonin Reuptake Inhibitor (SSRI) in patients with     CLBP in a prospective, randomized and double-blind clinical trial. The main hypothesis is:      -in comparison to placebo, subjects with CLBP and Cipralex report a significant reduction in     depressive symptoms (>= 50% of HAMD questionnaire) after 4 weeks of treatment.   "
181956|NCT00227305|"     The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate     (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.   "
181957|NCT00227318|"     The purpose of this study is to determine the effectiveness of candesartan cilexetil in     preventing hypertension in people with high normal blood pressure. Patients will be     randomized to either Candesartan or placebo for an initial 2-year period followed by a second     2-year period of placebo for all patients.   "
181958|NCT00227331|"     This is a clinical trial to determine if oral amoxicillin is equivalent in efficacy to     injectable penicillin (the standard treatment) in the treatment of WHO-defined severe     pneumonia in children between the ages of 2 and 59 months.   "
181959|NCT00227344|"     The objective of this prospective multicenter randomized study is to establish the     effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary     veins with radiofrequency (RF) ablation and creating additional lines of block with the aid     of the NAVISTAR® THERMOCOOL® catheter in conjunction with the CARTO™ EP Navigation System.     Effectiveness will be determined by comparing the chronic success of ablation therapy versus     antiarrhythmic drug therapy, defined as the absence of persistent tachyarrhythmias during the     first 24 months after a run-in phase of 2 months.   "
181963|NCT00227409|"     Previous study showed repeated lead chelation therapy significant reduced progressive renal     insufficiency in patients with chronic renal diseases and high-normal body lead burden in a     placebo-controlled, randomized, 2-year clinical trial, even factors that influence     progression, such as blood pressure, the presence or absence of hyperlipidemia, and urinary     protein excretion were well controlled.Since relative small sample size and short duration of     follow-up were noted in the previous study, whether repeated lead chelation therapy could     long-term retard the progression of renal insufficiency remains unknown. Hence, we conducted     a 51-month placebo-controlled clinical trial to assess the long-term effect of repeated     chelation in progressive renal insufficiency of patients with high-normal body lead burden.   "
181964|NCT00227422|"     The purpose of this study is to evaluate that the vaccine produced with the new process and     administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in     terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.   "
181965|NCT00227435|"     This study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral     activity of val-mCyd at doses ranging from 50 mg to 800 mg per day.   "
181966|NCT00227448|"     The ultimate goal of this multicenter, phase II study is to increase blood pressure until     either a neurologic response is seen or a target mean arterial pressure of 30% above baseline     is achieved. IV fluids, IV phenylephrine and/or IV norepinephrine are used to rapidly raise     mean arterial pressure in a controlled manner as serial assessments of neurologic function     are performed.   "
181967|NCT00227461|"     The study investigates the possibility that levetiracetam may improve the symptoms of chronic     post-stroke aphasia.   "
181968|NCT00227474|"     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective     immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune     response and prevent or delay the recurrence of cancer.      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients     with stage IIIB or stage IV breast cancer in remission.   "
181969|NCT00227487|"     The purpose of the study is to find correlations between non-invasive fecal tests of     intestinal inflammation and macro- and microscopic evaluation of duodenal and colonic     histology, disaccharidase activity, and intestinal permeability in children with autism.   "
181970|NCT00227500|"     This study is a randomised, placebo-controlled study of the effect of treatment with the     HMG-CoA reductase inhibitor, pravastatin, in HIV-infected, protease inhibitor treated     patients with high serum cholesterol. We hypothesise that pravastatin will result in greater     reductions in cholesterol than placebo when used in conjunction with appropriate dietary     advice.   "
181971|NCT00227513|"     This phase I trial is studying the side effects and best dose of vorinostat and bortezomib in     treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy,     such as vorinostat, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with     bortezomib may kill more tumor cells.   "
181972|NCT00227526|"     Most patients find that recovering from surgery is difficult particularly after abdominal     surgery for cancer or other intestinal disorders. The surgical stress, healing process and     concerns if further treatments are required suggest that the post-operative period may not be     the best time to get people to exercise to rehabilitate lost functions. Prehabilitation is     the process of enhancing functional capacity of the individual to enable him or her to     withstand an incoming stressor, such as surgery, and this study aims to evaluate the     effectiveness of prehabilitation for colorectal surgery. Two groups will be formed by a     random process and the prehabilitation group will use an exercise cycle and weights to build     endurance and strength for a 3-week period prior to surgery. The other group will receive     training about exercises that will help them move better after surgery. People who are     malnourished prior to surgery will receive nutritional supplements. The results of this trial     will be used to inform practitioners and patients alike of the benefits (or risks if any) of     exercise in preparing for surgery.   "
181973|NCT00227539|"     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before,     during, and after chemotherapy) may help doctors predict a patient's response to treatment     and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving combination chemotherapy after surgery may     kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well PET works in predicting response in     patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without     surgery for stage I, stage II, or stage III non-small cell lung cancer.   "
182000|NCT00227968|"     This study will evaluate the effectiveness of interpersonal and social rhythm therapy (IPSRT)     versus clinical status and symptom response therapy (CSSRT) in reinforcing the treatment of     bipolar disorder in individuals who are currently undergoing medication treatment for the     disorder.   "
181974|NCT00227565|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with     carboplatin works in treating patients with extensive-stage small cell lung cancer.   "
181975|NCT00227591|"     This phase II trial is studying how well giving lenalidomide together with prednisone works     in treating patients with myelofibrosis. Lenalidomide may stop the growth of myelofibrosis by     blocking blood flow to the cancer. It may also stimulate the immune system in different ways     and stop cancer cells from growing. Drugs used in chemotherapy, such as prednisone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving lenalidomide together with prednisone may kill more cancer cells.   "
182034|NCT00228410|"     To compare the safety and the efficacy of tigecycline to vancomycin with aztreonam in     treating hospitalized patients with complicated skin and/or skin structure infections.   "
181976|NCT00227617|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab     may also stop the growth of neuroendocrine tumors by blocking blood flow to the tumor. Giving     combination chemotherapy together with bevacizumab may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects of giving combination     chemotherapy together with bevacizumab and to see how well it works in treating patients with     advanced neuroendocrine tumors.   "
181977|NCT00227630|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill     tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it     can be removed. Giving radiation therapy after surgery may kill any tumor cells that remain     after surgery.      PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin     followed by surgery and radiation therapy works in treating patients with malignant pleural     mesothelioma.   "
181978|NCT00227656|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Pegylated interferon alfa-2a may interfere with the growth of tumor cells. Giving     capecitabine together with pegylated interferon alfa-2a may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving capecitabine together with pegylated     interferon alfa-2a works in treating patients with recurrent or progressive brain metastases     due to breast cancer.   "
181979|NCT00227669|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It     is not yet known whether giving gemcitabine together with docetaxel is more effective than     giving gemcitabine alone as second-line therapy in treating uterine or soft tissue     leiomyosarcoma.      PURPOSE: This randomized phase II trial is studying gemcitabine and docetaxel to see how well     they work compared to gemcitabine alone as second-line therapy in treating patients with     metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma.   "
181980|NCT00227682|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, dexamethasone, and ascorbic     acid, work in different ways to stop the growth of cancer cells, either by killing the cells     or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may     kill more cancer cells. Sometimes when chemotherapy is given, it does not stop the growth of     cancer cells. The cancer is said to be resistant to chemotherapy. Giving arsenic trioxide     together with chemotherapy may reduce drug resistance and allow the cancer cells to be     killed. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the     cancer. Giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid     may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with     thalidomide, dexamethasone, and ascorbic acid works in treating patients with relapsed or     refractory multiple myeloma.   "
181981|NCT00227695|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. It is not yet known whether giving     rituximab over a short period of time is more effective than giving it over a long period of     time in treating follicular non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying rituximab to see how well it works when     given over a short period of time compared to when given over a long period of time in     treating patients with follicular non-Hodgkin's lymphoma.   "
181982|NCT00227708|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Chemotherapy drugs may have different effects in older patients.      PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients     with locally advanced or metastatic non-small cell lung cancer.   "
181983|NCT00227721|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel     works in treating patients with relapsed or refractory ovarian epithelial or peritoneal     cancer.   "
181995|NCT00227903|"     The purpose of this study is... To assess whether a behavioral treatment that combines     motivational enhancement and cognitive skills training therapy (MET-CBT) is more effective     than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g.     marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using     and dependent women; 2) decreasing HIV risk behavior; 3) improving birth outcomes (longer     gestations and greater birth weight).   "
181984|NCT00227734|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known     whether giving capecitabine and oxaliplatin together with cetuximab is more effective than     capecitabine and oxaliplatin in treating colorectal cancer.      PURPOSE: This randomized phase II trial is studying how well giving capecitabine and     oxaliplatin together with cetuximab works compared to capecitabine and oxaliplatin in     treating patients with metastatic colorectal cancer that cannot be removed by surgery.   "
181985|NCT00227747|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving more     than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy     together with combination chemotherapy before surgery may shrink the tumor so it can be     removed. It is not yet known whether giving radiation therapy together with capecitabine is     more effective with or without oxaliplatin before surgery in treating rectal cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and     oxaliplatin to see how well they work compared to radiation therapy and capecitabine in     treating patients who are undergoing surgery for stage II or stage III rectal cancer.   "
181986|NCT00227760|"     This phase II trial studies how well cediranib maleate works in treating patients with     recurrent or metastatic kidney cancer that cannot be removed by surgery. Cediranib maleate     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
181987|NCT00227773|"     RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by stopping blood flow to the tumor. Octreotide may help control     symptoms, such as diarrhea, caused by the tumor. Giving vatalanib together with octreotide     may be an effective treatment for neuroendocrine tumors.      PURPOSE: This phase II trial is studying how well giving vatalanib together with octreotide     works in treating patients with progressive neuroendocrine tumors.   "
181988|NCT00227786|"     RATIONALE: Stop-smoking plans suggested by physicians may help patients quit smoking.     Studying how physicians give stop-smoking treatment as family doctors may increase the chance     of smokers receiving such treatment.      PURPOSE: This randomized clinical trial is studying physicians' practice patterns to see if     regular feedback to the physician increases the chance of adult smokers receiving     stop-smoking treatment.   "
181989|NCT00227812|"     The purpose of this study is to test whether cognitive behavioral therapy and bupropion     hydrochloride will help cocaine users, who are depressed, reduce or end their cocaine use and     improve their mood.   "
181990|NCT00227825|"     The purpose of this study is to conduct a pilot study of Motivational Enhancement Therapy     (MET), an empirically validated behavioral change strategy, with young adults who are HIV +.     The aim is to determine if MET is effective in increasing general health promotion behaviors,     adherence to HIV+ specific medical treatment over and above taking medication, and decreasing     risky behaviors in young adults who are HIV positive. The longer-term objective is to     identify and way to decrease HIV transmission rates, disease progression, illness episodes,     and hospitalizations in this high-risk population.      Hypotheses: 1)Youth receiving the motivational intervention plus referrals will report     greater reductions in risky behaviors than youth in the control group receiving standard care     plus referrals at 3-months post-baseline. This hypothesis will first be tested in the whole     sample using an overall risk index. Then, the hypothesis will be tested with each behavior     (reduced drug and alcohol use, condom use, taking medications,) within the subgroups     reporting problem levels of that behavior; 2)Youth in the intervention group will demonstrate     improved viral loads, will report greater improvement in perceived health status, depression,     general psychological distress, disclosure to sexual partners, and will demonstrate greater     attendance of medical and support service appointments than youth in the control group at 3     months post-baseline; 3)Youth in the intervention group will report greater reductions in     temptation to engage in risky behaviors, increased self-efficacy, and improvements in     readiness to change their behavior than youth in the control group at 3 months post-baseline;     4)The differences between the intervention and control group from pre- to post- intervention     will be maintained at 6, 9, 12, and 15 months post-baseline (3, 6, 9, and 12 months after     intervention completion).   "
181991|NCT00227838|"     The purpose of this study is to modify Integrated Group Therapy (IGT), which is has been     found successful for patients with bipolar disorder (BD) and substance use disorder(SUD), so     that it can be more readily adopted by community drug abuse treatment programs. IGT is being     reduced from 20 to 12 sessions in this trial, and is being conducted by front-line drug     counselors, to test its effectiveness in a more community-based setting. The training has     been expanded so that counselors without much psychopathology training or cognitive     behavioral therapy experience can conduct IGT.   "
181992|NCT00227864|"     The purpose of this study is to examine the efficacy of a brief motivational intervention on     marijuana use and sex-risk behavior in young women.   "
181993|NCT00227877|"     The purpose of this study is to test the effectiveness of a brief intervention for alcohol     and drug use in adolescents that a primary care doctor can give in his/her office. The study     will be conducted in nine primary care offices in three New England states, and in ten     pediatric offices in Prague, Czech Republic (CZR).      We hypothesize that:        1. Among 12-18 year old well care patients who screen positive for drug/alcohol use, the          experimental intervention administered by trained primary care providers will be more          effective than standard care in decreasing drug and alcohol use;        2. Among 12-18 year old well care patients who screen negative for drug/alcohol use, the          experimental intervention administered by trained primary care providers will be more          effective than standard care in decreasing initiation of drug and alcohol use as          measured by self-reports of substance use;        3. Among 12-18 year old well care patients who are at risk for driving/riding while          impaired (DRWI), the experimental intervention administered by trained primary care          providers will be more effective than standard care in decreasing DRWI risk behavior as          measured by a standardized scale.   "
181994|NCT00227890|"     This study will focus on treating substance abusing incarcerated teens using individually     administered Motivational Interviewing (MI) followed by group Cognitive Behavior Therapy     (CBT). The control group receives individualized Relaxation Training (RT) followed by group     Treatment as Usual (TU). Currently, there is little research regarding effective group     treatments for incarcerated teens and this study will address this gap in our knowledge base.     We seek to reduce substance use and associated risky behaviors post-release (including     driving under the influence, risky sexual behaviors, etc.).   "
182001|NCT00227981|"     This study will evaluate the effectiveness of maintenance interpersonal psychotherapy (IPT)     in preventing relapse of depression in women who have required combined psychotherapy and     pharmacotherapy treatment to obtain a remission of depression symptoms.   "
182002|NCT00227994|"     This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors     in improving cognitive function and overall rehabilitation in elderly stroke survivors.   "
182003|NCT00228007|"     This study will evaluate the effectiveness of antidepressant medication treatment in reducing     HIV risk behaviors in intravenous drug users with depression.   "
182035|NCT00228423|"     The purpose of this study is to determine whether the combination of clopidogrel with aspirin     prevents the development of blockages (atherosclerosis) in vein grafts one year after     coronary artery bypass surgery (CABG) compared to aspirin alone.   "
182004|NCT00228020|"     The aim of this study is assess the safety and efficacy of the treatment regimen of     basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to     cyclosporine microemulsion, MMF and prednisone in the time to first biopsy proven acute     rejection episode or treatment failure during the first 6 months post-transplantation in     pediatric renal allograft recipients.   "
182005|NCT00228033|"     This study will evaluate the effectiveness of taking supplemental calcium while pregnant in     reducing the risk of postpartum depression.   "
182006|NCT00228046|"     This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant     treatment is more effective than stimulant treatment alone in reducing aggressive behavior     among children with attention deficit hyperactivity disorder (ADHD).   "
182007|NCT00228059|"     This extension study is designed to investigate the long-term safety and tolerability of     licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind     study CLIC477D2301.   "
182008|NCT00228072|"     The purpose of this study is to determine if suction-curettage of the axilla is favorable in     regard to effect, recovery and cosmetic appearance compared to standard surgical excision of     the skin of the axilla in case of excessive sweating.   "
182009|NCT00228085|"     CNS reorganization is evidenced in patients with CNS lesion, no exception to the patients     with spinal cord injury. The paraplegics have to increase their loading of upper extremities     to compesate the lost function of lower extremities. We hypothesize that CNS reorganization     can happen in the chronic paraplegics. We try to compare the changes of parameters of     transcranial magnetic stimulation in these patients with the normal population     cross-sectionally.   "
182010|NCT00228098|"     Patients with stroke or transient ischemic attach should receive advise on smoking cessation.     It is however unknown if an intensive smoking cessation program is better than ordinary     advise on smoking cessation during hospitalisation for stroke or transient ischemic attack.      The aim of the study was to assess if an intensive smoking cessation program made more     patients stop smoking after stroke or transient ischemic attack.   "
182011|NCT00228111|"     The aim of this study is to establish the additional effectiveness and costs of routine     thoraco-abdominal computed tomography (CT) in blunt trauma patients versus conventional     radiological imaging and to determine which clinical parameters predict a high additional     value of routine thoraco-abdominal CT.   "
182012|NCT00228124|"     The purpose of this study is to determine, in patients entered on the National Cancer     Institute of Canada (NCIC)-PR.7 trial of intermittent versus continuous androgen ablation,     whether the rates of osteoporosis, fractures, and alteration in body composition are reduced     by intermittent androgen ablation.      There will be two groups of patients:        1. A cross-sectional group of 150 patients registered in PR.7 prior to January 1, 2002,          randomized between intermittent androgen suppression (IAS) and continuous androgen          suppression (CAS) (75 from each group). Patients who have definite bone metastases are          excluded from this study. Biochemical failure does not exclude the patient.        2. A longitudinal study of 150 newly accrued patients randomized between IAS and CAS (75          from each group). These patients will have baseline evaluation of bone loss and body          composition, longitudinal monitoring and follow-up on an annual basis for patients on          CAS and at the end of each “off cycle” of IAS. Patients taking bisphosphonates are          excluded from this study.   "
182013|NCT00228137|"     The purpose of this study is to compare the functional outcome of two different total knee     prostheses in a prospective randomised study.   "
182014|NCT00228150|"     The primary objective is to assess the effect of SR57667B at the dose of 4 mg/d on the     progression of Parkinson symptoms in patients with early PD. The primary outcome will be the     time to progression of disability warranting initiation of L-dopa or a dopamine agonist.     Secondary outcomes will comprise assessments of symptoms, activities of daily living and     global clinical status.   "
182015|NCT00228163|"     The primary objective is to assess the long-term safety of teriflunomide in multiple     sclerosis subjects. The secondary objective is to assess the long-term efficacy.   "
182016|NCT00228176|"     Objectives:        -  Primary: To evaluate the effect of rimonabant 20-mg once daily in comparison with          placebo, on the quantitative progression of atherosclerosis as assessed by carotid          artery intima-media thickness (CIMT)        -  Secondary: To evaluate the safety and tolerability of the above rimonabant regimen in          the study population of atherosclerosis patients.   "
182017|NCT00228189|"     Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As     such they are currently used in clinical vaccination protocols in cancer patients. We     evaluate the ability of mature DCs pulsed with carcinoembryonic antigen (CEA)-peptide (arm A)     or electroporated with CEA-mRNA (arm B) to induce CEA-specific T cell responses in patients     with resectable liver metastases from colorectal cancer. To evaluate immune responses,     CEA-specific T cell reactivity is monitored in peripheral blood, resected abdominal lymph     nodes, tumor tissue and biopsies of vaccination sites and post-treatment DTH skin tests.     Patients are vaccinated intradermally and intravenously with CEA-peptide pulsed mature DCs     three times prior to resection of liver metastases. In 2007 a side-study has been added (arm     C), in which patients with stage III or high-risk stage II colorectal cancer that are     amenable for standard adjuvant oxaliplatin/capecitabine therapy are vaccinated with     CEApeptide-pulsed DCs. Also in this group, safety and immune responses in peripheral blood     and the DTH-skin test are the primary endpoints. Results are compared with the results     obtained in arm A.   "
182053|NCT00219180|"     To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan     given to patients with essential hypertension   "
182018|NCT00228202|"     The researchers select 100 cytomegalovirus (CMV) DNA samples from patients diagnosed with CMV     infection. Patients include bone marrow transplant patients, pregnant women and newborns. The     researchers determine viral load by real-time polymerase chain reaction (PCR). They amplify     CMV-gB sequences by PCR and type by sequencing and restriction fragment length polymorphism     (RFLP). The researchers obtain clinical data from patients' records. They examine association     between patients' clinical status and CMV-gB genotype and viral load.   "
182019|NCT00228215|"     A randomized controlled trial design will be used to answer whether a behavioral-educational     sleep intervention and support from a nurse in the immediate postpartum improves maternal and     infant sleep 6 weeks later.   "
182020|NCT00228228|"     In the present study, we, the investigators at Sheba Medical Center, intend to evaluate T     cell vaccination (TCV) in patients with probable multiple sclerosis (MS) within up to 3     months after the first clinical attack. It is of the utmost importance to evaluate the     treatment effects at the onset of disease, i.e. in patients with probable MS, in order to     evaluate whether early treatment can prevent the second attack (conversion to definite MS).     Moreover, at disease onset, the immunological process of epitope spreading associated with     the exposure of the immune system to myelin antigens is still limited. With additional     attacks, increased recognition of new self-determinants of encephalitogenic peptides     presented to the immune system during the inflammatory process occurs, and enhances further     disease activity. The aim of the early TCV treatment approach is to stop this process as     early as possible, during the onset of the disease, thus preventing additional attacks and     disease progression.      We will evaluate the effect of TCV on clinical, immunological and magnetic resonance imaging     (MRI) parameters in patients with probable MS.   "
182021|NCT00228241|"     1. Background - Pacemaker treatment gives asynchronous activation of the heart that often          results in decreased heart function and clinical heart failure. New pacemaker types that          stimulates both left and right ventricle ( biventricular pacemakers ) is introduced to          the treatment of patients with heart failure, decreased left ventricular function and          ECG signs with left bundle branch block.        2. Hypothesis - Ventricular pacing results in remodelling of the left ventricle and          decreased left ventricular function. Biventricular pacing do not do this. Ventricular          pacing results in heart failure and increased wall stress with decreased 6 minutes walk          test and increased BNP in blood samples. This is not seen by biventricular pacing.        3. Materials and methods - 3 studies. All patients are examined by echocardiography          2-dimensional, M-mode, 3-dimensional and with tissue harmonic imaging. Study 1) Patients          with AV-conduction disorder that needs pacemaker treatment are randomized to          DDD-pacemaker or biventricular pacemaker. Study 2) Patients with sick sinus syndrome          included in DANPACE are randomized to AAI- or DDD-pacemaker. Study 3 ) Acute study to          examine the changes in patients AV-block before DDD-pacemaker implantation and after          implantation.   "
182022|NCT00228254|"     Children with malnutrition are often low in some nutrients, like zinc or vitamin A, that     could help them fight off infections like pneumonia. Our study was designed to see if     children who got supplements of zinc or vitamin A had fewer infections.   "
182023|NCT00228267|"     Hypothesis A single subanesthetic dose of propofol will result in improved pain and quality     of life for the next 30 days in persons with chronic daily headache (CDH)      Specific objectives To measure the effect of a single infusion of propofol at 40 mcg / kg /     minute over 60 mins on headache-related quality of life (measured by the Headache Disability     Index) and on headache severity (measured by the Headache Index) in subjects with chronic     daily headache over 30 days45-47   "
182024|NCT00228280|"     Ph.D project: Periapical bone healing after apicectomy with and without retrograde root     filling.      The aim of this study is to assess periapical bone healing after apicectomy without a filling     and apicectomy combined with a retrograde filling material, MTA. Further, we will estimate     risk factors in non-healing cases.      Study hypothesis: There is no difference in treatment outcome between:      Periapical bone healing after apicectomy with retrograde root filling and Periapical bone     healing after apicectomy without retrograde root filling   "
182025|NCT00228293|"     Using an investigational monitor/defibrillator that passively records CPR quality parameters,     including chest compression rate and depth and ventilation rate and volume, we are     prospectively recording CPR quality during sequential in-hospital cardiac arrests at the     University of Chicago Hospitals. Using an audio feedback system linked to this device, we are     studying whether such audio feedback improves CPR quality when provided to rescuers trained     in the use of the device.   "
182026|NCT00228306|"     Determine if attaining aerobic fitness is beneficial in producing cortical neuroplasticity in     individuals with chronic stroke.   "
182027|NCT00228319|"     The purpose of this study is to try and understand if there is added benefit or increased     harm when antioxidant nutritional supplements are added to traditional chemotherapy in the     treatment of ovarian cancer.   "
182028|NCT00228332|"     A Double-blind, placebo-controlled trial investigating the effect of a treatment with     zinkgluconaat for verrucae vulgares   "
182029|NCT00228345|"     The purpose of this study is to determine whether impaired glucose handling (abnormality in     the way the body processes blood sugar) can cause a neuropathy (damage to the nerves).   "
182030|NCT00228358|"     This phase I trial studies the safety and the ability to expand laboratory-treated T cells     when given together with cyclophosphamide or denileukin diftitox in treating patients with     human epidermal growth factor receptor (HER)-2/neu overexpressing metastatic breast cancer,     ovarian cancer, or non-small cell lung cancer previously treated with HER-2/neu vaccine.     Laboratory-expanded T cells may help the immune system in different ways and stop tumor cells     from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Biological therapy, such as denileukin diftitox, may stimulate the immune system in     different ways and stop tumor cells from growing. Giving laboratory-treated T cells together     with cyclophosphamide or denileukin diftitox may allow the immune system to kill more tumor     cells   "
182054|NCT00219193|"     To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren     / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately     responsive to HCTZ 25 mg   "
182031|NCT00228371|"     The aim of this study is to evaluate the effectiveness and the safety of deep brain     stimulation in drug resistant epilepsy.      This is a double blind, controlled and randomized clinical trial with two cross-over groups     and four phases.      Phase 1 : base line, open phase consisting of follow-up of patients with their standard     treatment.      Phase 2 : Randomisation, lead implantation, followed by 3 months wash out period with the     stimulator switch OFF.      Phase 3 : cross-over, double blind phase : 3 months with stimulator switch ON or OFF     depending on randomization allocation, followed by 3 months with the stimulator switch on the     opposite position. The placebo consisting of turn OFF the stimulator.      Phase 4 : open phase, one year follow-up of all patients with the stimulator switch ON.   "
182036|NCT00228436|"     The purpose of this study was to evaluate the safety, pharmacodynamics (PD), and     pharmacokinetics (PK) of multiple subcutaneous injections of peginesatide in participants     with chronic kidney disease (CKD) not on dialysis who had not received erythropoiesis     stimulating agent (ESA) treatment.   "
182037|NCT00228449|"     The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and     pharmacokinetics (PK) of multiple intravenous doses of peginesatide in participants with     chronic kidney disease (CKD) who are on hemodialysis.   "
182038|NCT00228462|"     This study is being carried out to see if quetiapine (Seroquel) is effective in preventing     patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it     compares with non-active treatment.   "
182039|NCT00228475|"     The purpose to measure the concentration of budesonide in breast milk of asthmatic mothers on     their normal maintenance treatment with budesonide (Pulmicort Turbuhaler), and to estimate     the exposure of budesonide to infants.   "
182040|NCT00228488|"     Two different patient populations will be targeted for this study. The first population (SP1)     will include patients with recurrent/metastatic head and neck cancers, excluding salivary     gland carcinomas. The second population (SP2) will include treatment-naïve patients with     locally advanced squamous cell head and neck cancer (SCHNC).      SP1 will be treated with palliative intent and the patients can be treatment-naïve or have     received prior chemotherapy. Study treatment will consist of Iressa (gefitinib) alone.      SP2 will be treated with radical intent. The patients must be treatment-naïve and study     treatment will consist of induction Iressa for 3 weeks followed by a combination of Iressa     plus cisplatin and concurrent irradiation.   "
182041|NCT00228514|"     At one site, patients participating in the Corona main study are asked to participate in the     PET-substudy. Before and 6 months after study medication is started a Positron Emission     Tomography (PET-scan) is performed to study the effect of rosuvastatin in Chronic Heart     Failure on myocardial perfusion (reserve)   "
182042|NCT00228527|"     To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in     children 1 to 11 years old with inflammation of their esophagus or food pipe (esophagitis)     caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.      To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the     lining of the food pipe.      To collect information that will describe the psychological, social, and economic effects on     the primary caregiver of raising children ages 1 to 5 years old with GERD.   "
182043|NCT00228540|"     An 8-week, Open-Label Study to Characterize the Response to Modafinil (85mg Film-Coated     Tablet) Treatment at Dosages up to 425mg/Day in Children and Adolescents with     Attention-Deficit/Hyperactivity Disorder (ADHD) (With an Open-Ended Extension Period)   "
182044|NCT00228553|"     A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of     Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated     with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep     Disorder   "
182045|NCT00228566|"     The purpose of this study is to assess patient reported outcomes with armodafinil treatment     in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to     engage in life activities (ie, daily or work and family and/or social activities), and     effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also     be assessed.   "
182046|NCT00219089|"     To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension     and diabetes mellitus   "
182047|NCT00219102|"     To evaluate the blood pressure lowering effect and safety of aliskiren used in combination     with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not     adequately responsive to the combination of valsartan and hydrochlorothiazide   "
182048|NCT00219115|"     To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and     HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25     mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.   "
182049|NCT00219128|"     Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to     placebo in patients with essential hypertension   "
182050|NCT00219141|"     To compare the efficacy and safety of aliskiren in combination with losartan compared to     losartan on the regression of the increased size of the left ventricle in overweight patients     with high blood pressure.   "
182051|NCT00219154|"     This study is designed to compare the long-term efficacy and safety of an aliskiren based     regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients     with essential hypertension.   "
182052|NCT00219167|"     After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible     patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg     for a period of 8 weeks   "
182055|NCT00219219|"     The present study will give information about the course over time in skeletal-related events     (SRE) in prostate cancer patients with bone metastases treated with zoledronic acid 4 mg     administered as a 15-minute infusion every 4 weeks for a maximum of 15 infusions. The     protocol will enroll patients with recent diagnosis of bone metastases from prostate cancer     who are hormone-refractory, hormone-naïve or still hormone-sensitive, that represent the     entire population of prostate cancer patients   "
182056|NCT00219232|"     The goal of this research study is to evaluate, in the open-label extension phase, the safety     and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's     Disease   "
182057|NCT00219245|"     Patients who completed the 12-week double blind protocol may enter this 26-week, open-label     extension. This extension will give patients who complete the study an opportunity to receive     treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive     deficits related to traumatic brain injury. This extension will enable further evaluation of     patients, as well as analyses to be conducted examining response to treatments in the     original drug and placebo groups.   "
182058|NCT00219258|"     Zoledronic acid is a medication that slows the breakdown of bone. This study will assess the     efficacy and safety of zoledronic acid in Chinese patients with multiple myeloma or other     solid tumors with bone metastases.   "
182061|NCT00219297|"     The study objective is to evaluate the safety and efficacy of patupilone with respect to     early progression and response of patients with non-small cell lung cancer (NSCLC) metastatic     to the brain, who have progressed after chemotherapy, surgery and/or radiation.   "
182062|NCT00219310|"     This trial will assess whether RGH patients who have two recurrent episodes within a three     month period would benefit from suppressive treatment and whether patients prefer episodic     therapy or suppressive therapy for the treatment of their RGH.   "
182063|NCT00219323|"     This study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult     patients with moderate to severe bronchial asthma.      THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES   "
182064|NCT00219336|"     The study evaluated the effectiveness of a mail-based self-guided motivational intervention     based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) with female students and     non-students 18 to 44 years of age living in Florida. The investigators hypothesize that the     motivational intervention will significantly reduce more women's risk of an AEP than will an     informational intervention aimed at preventing fetal alcohol syndrome. Materials will be     available in Spanish and English   "
182065|NCT00219349|"     The goals of this pilot study are as follows:      1) To disseminate and examine the effectiveness of a manualized, individual,     cognitive-behavioral psychotherapy (CBT) for adults with Generalized Anxiety Disorder(GAD),     2) to test the effectiveness of augmentation (the addition of) antidepressant therapy in     participants who do not fully respond to CBT, and 3) to examine individual and clinical     predictors of non-response to CBT and predictors of response to augmentation antidepressant     therapy. A related goal is to examine the maintenance of treatment gains obtained from CBT     alone and CBT with augmentation antidepressant therapy, over a twenty-four month follow-up     period. This study will serve as a pilot investigation in preparation for a larger federally     funded study using this treatment approach. We hypothesize that CBT will result in remission     (no longer having GAD) and/or high endstate functioning (clinically meaningful improvement)     in approximately 40-50% of participants. Further, we hypothesize that augmentation     antidepressant therapy in participants who do not fully respond to CBT will result in further     clinically significant improvement.   "
182066|NCT00219362|"     Prior pilot studies have shown that four monthly injections of ALVAC-HIV (vCP1433) are     immunogenic in 60% HIV-infected patients with a boosting effect obtained after 1 or 2     injections followed by a plateau or a decrease of these responses prior to interrupting     therapy. The goal of the present study is to look for an improved vaccination schedule in     terms of strength and duration of the HIV-specific immunity induced by the HIV-recombinant     canary pox vector ALVAC-HIV (vCP1452) by testing a strategy of immunization involving a first     series of two versus three monthly injections followed by a boost three months later.   "
182067|NCT00219375|"     The purpose of this study is to confirm the efficacy and safety of sivelestat in patients     with acute lung injury associated with systemic inflammatory response syndrome. The results     will be compared to the study with conventional treatment without sivelestat.   "
182068|NCT00219388|"     The purpose of this study is to compare the effects of levosimendan with dobutamine on heart     function in patients suffering of severe chronic heart failure.   "
182069|NCT00219401|"     The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal     vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the     Telethon Institute for Child Health Research and the Department of Paediatrics, University of     Western Australia will collaborate to examine very closely the safety of neonatal     vaccination, particularly with regard to impact on the development of immunity and response     to other vaccines given to infants. This study will also provide a unique opportunity for     training of PNG and Australian scientists in both countries.   "
182070|NCT00219414|"     The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn     Apheresis System to treat the signs and symptoms of ulcerative colitis.   "
182071|NCT00219427|"     1. Purpose           a. Examination on Efficacy of Retina Projection System        2. Patients           a. Low vision patients        3. Methods             1. Vision aids                  -  Retina Projection System                  -  Face-mounted video display as control             2. Comparison of Reading Speeds with both vision aids   "
182072|NCT00219440|"     We hypothesized that a portion controlled diet would prevent the weight gain associated with     the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months     randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a     standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.   "
182073|NCT00219453|"     The primary purpose of this study is to determine the ability of the Protector Cap Jet     Injector to prevent cross-contamination in the next injection sample. The hypothesis is that     the Protector Cap Jet Injector will prevent contamination in the next injection sample, even     following injection of volunteers with high levels of hepatitis B virus.   "
182074|NCT00219466|"     To evaluate whether Desitin; Zinc Oxide Diaper Rash Ointment (Desitin Original) and Desitin     Creamy; Zinc Oxide Diaper Rash Ointment (Desitin Creamy) provide relief of the signs and     symptoms associated with diaper rash after 12 and 24 hours of product application.   "
182075|NCT00219479|"     It is unclear how enteral nutrition via a feeding tube should be given when a patient is     receiving enteral Dilantin. Some caregivers hold the feedings for one hour before and one     hour after the Dilantin dose to insure adequate absorption of the medication and some     caregivers think that the feedings do not need to be interrupted.      Hypothesis: Dilantin levels will remain therapeutic when enteral nutrition is given     continuously during the administration of enteral Dilantin.      The objective of this study is to determine Dilantin levels when enteral feedings are given     by the continuous method. Thirty patients will be studied. When Dilantin levels are in the     therapeutic range for 2 consecutive days on interrupted feedings (baseline), the patient will     be switched to continuous feedings uninterrupted for the medication, for 7 days. Dilantin     levels will be checked daily and if the levels become subtherapeutic an intravenous (IV)     bolus of Dilantin will be given and the enteral dose will be increased (doses determined by     primary caregiver). Serum albumin will be measured at baseline and at the beginning and end     of each week, in order to calculate free Dilantin.   "
182076|NCT00219492|"     Chest pain is a common clinical complaint. About 30% patients with chest pain will have a     normal coronary angiogram and are described as having noncardiac chest pain (NCCP). It is     estimated that 25% of the population complain of chest pain at some time in their lifetime.     The pathogenesis of NCCP is unknown. Esophageal hypersensitivity as a result of inflammation     is considered to be an important mechanism in the development of this pain sensation. Little     is currently known about the interaction between inflammatory mediators and peripheral     afferent nerve terminals in the esophagus. The mast cell is one of the most enriched     pro-inflammatory cells in the gastrointestinal tract. Activation of the mucosal mast cell     releases a variety of mediators into adjacent tissues. We hypothesize that mediators released     by mast cells sensitize esophageal nociceptors and induce pain sensation.   "
182077|NCT00219505|"     Acupuncture has been used for centuries in China in the treatment of diarrhea. Our hypothesis     is that acupuncture is effective in the treatment of abdominal pain and diarrhea in patients     with diarrhea-predominant IBS   "
182078|NCT00219518|"     We hypothesize that defecatory disorders can be described in mechanical terms which would     allow a mechanistic description of disorders which would in turn allow better directed     biofeedback mechanisms to treat disorders of defecation.   "
182079|NCT00219531|"     The hypothesis of the study is that women perceive intestinal stimulation (rectal balloon     distention) differently in different phases of the menstrual cycle, i.e there is an effect of     hormones on the sensory pathway, and that this difference is reflected in the Central Nervous     System processing of this signal. We also hypothesize that there is a difference in     perception between control subjects and subjects with the irritable bowel syndrome.   "
182080|NCT00219544|"     This study will measure the impact of treatment with pregabalin in adult men and women who     have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the     peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).   "
182081|NCT00219557|"     This is a Phase 2 study being conducted at multiple centers in the United States, Europe and     Canada. Patients having pancreatic cancer that is locally advanced or that has spread to     other parts of the body (i.e., metastatic) are eligible to participate. Patients must have     not had any prior systemic treatment for advanced disease. The purpose of the study is to     test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine     is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall     survival.   "
182082|NCT00219570|"     To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and     safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne     vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify     the clinical positioning of Dalacin T Gel.   "
182083|NCT00219583|"     Assessment of efficacy and safety UK-390,957.   "
182084|NCT00219596|"     to compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and     Timolol in subjects with open-angel glaucoma or ocular hypertension   "
182085|NCT00219609|"     To determine whether UK-390,957 is a safe treatment for premature ejaculation.   "
182086|NCT00219622|"     This an initial proof of concept, phase to study to assess the safety and efficacy of     tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary     Disease   "
182087|NCT00219635|"     Assessment of efficacy and safety UK-390,957   "
182088|NCT00219648|"     PEP03 is a new chemical entity developed as a highly selective, potent, and orally active     5-LO inhibitor. PEP03 exerts its action by blocking the generation of both cysteinyl LTs and     LTB4. These LTs have been associated with the inflammatory response in the lung and with the     clinical sequelae, including bronchospasm. Preclinical pharmacological in- vitro, ex-vivo and     in-vivo testing indicates that PEP03 has multiple beneficial actions including prevention of     bronchoconstriction, and reduction of vascular leakage, cellular infiltration, and bronchial     hyperresponsiveness.      Clinical studies in asthmatic patients indicate that PEP03 improved FEV1 and other secondary     endpoints, such as morning and evening peak flow, daytime and nighttime symptoms score,     beta-agonist use, physician’s and patient’s global impression of change. Since leukotrienes     have been suggested to be involved in the pathophysiology of COPD, this study is designed to     explore the clinical utility of PEP03 for the treatment of moderate COPD.6; 7; 8; 9   "
182089|NCT00219661|"     The purpose of this study is to determine whether drainage of subglottic secretions is     effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's     patients.   "
189215|NCT00315588|"     The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell     transplantation, in patients with type 1 diabetes mellitus who have a stable kidney     allograft.   "
182091|NCT00219687|"     The purpose of this study is to determine whether dispatcher-assisted CPR instructions with     compressions and ventilations versus dispatcher-assisted CPR instructions with compressions     only improves survival from out-of-hospital cardiac arrests.   "
182092|NCT00219700|"     To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and     incidence of adverse events   "
182093|NCT00219713|"     Bone marrow biopsy is a painful medical procedure often performed with local anesthetic.      Therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients     who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an     equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. Pain measurement     used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal     ruler   "
182094|NCT00219726|"     The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in     patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem     cell transplantation.   "
182095|NCT00219739|"     To test whether increasing the dose of imatinib or combining it with IFNalpha or ara-C     increases the rate of molecular response (as measured by the decrease in BCR-ABL transcripts     after 12 months of treatment) in patients with previously untreated CML in chronic phase.      To compare overall survival in a selected arm according to molecular response at 1 year from     randomization with the reference arm.   "
191643|NCT00353496|"     The study will compare the difference between lanreotide Autogel and placebo on progression     free survival in patients who have an endocrine tumour in the pancreas or intestines.   "
182096|NCT00219752|"     The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in     patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis     of cml is being performed within 1 year. Quality of life will be carefully assessed.   "
182097|NCT00219765|"     The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated     with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous     leukemia in myeloid acute phase.   "
182098|NCT00219778|"     The first indication of hysterectomies in France are uterine leiomyomas. When they are     symptomatic leiomyomas are particularly responsables of an increase of menstruations duration     and volume. Echography is the reference exam for the diagnosis. It exists two treatments     ways:-firstly progestatives and antifibrinolytics for the treatment of hemorragic symptoms,     -secondly LH-RH analogs for the treatment of leiomyomas volume and hemorragic symptoms but     just used for a small period because of the risk of osteoporosis.      Different studies with different doses of mifepristone were released. The authors observe a     decrease of leiomyomas volume. Based on this experience the present placebo controlled study     has for objectives:-to confirm the efficacy of 10 mg oral mifepristone during 24 weeks in the     volume decrease and in symptoms of leiomyomas, - to assess the safety of the treatment. The     aim is to avoid or delay the hysterectomy of non menopausal patients. During the study     patients will be evaluated with biological exams, clinical exams, echographies, medical     interrogations and their diary cards.   "
182099|NCT00219791|"     To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate     (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with     intrathecal MTX overdose.   "
182100|NCT00219804|"     The primary objective of this study was to establish the absolute reduction of chorea in     participants with Huntington's disease(HD) treated with tetrabenazine or placebo   "
182101|NCT00219817|"     Anorexia and weight loss are devastating complications in late-stage cancer patients and is     strongly associated with mortality in these patients. Activation of Ghrelin receptors have     been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity     and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced     anorexia and weight loss. This study will test the safety and efficacy of RC-1291 in the     treatment of cancer patients with anorexia and weight loss.   "
182102|NCT00219830|"     The purpose of this study is to investigate if a home-based walking program is an acceptable     alternative for those who choose not to attend formal cardiac rehabilitation programs and if     such a program has an effect on coronary risk or physical fitness.   "
182103|NCT00219843|"     The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the     treatment of metastatic melanoma. This study will also include a preliminary assessment of     response of treated and untreated lesions by clinical evaluation at follow-up of 12 to 24     weeks following IL PV-10 treatment.   "
182104|NCT00219856|"     Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No     data are available concerning the potential benefit of a total anaesthesia with propofol in     partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver     insufficiency that could be related in part to the oxidative stress induced by clamping the     hepatic vessels during the surgical intervention. Our hypothesis is that propofol, by     increasing liver resistance to this ischemia-reperfusion phenomenon, could improve the     remaining liver function recovery, and therefore could reduce post surgical morbidity.      The aim of the study is to evaluate the anti oxidant effects of propofol compared to another     widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection     with hepatic vessels clamping. The primary endpoint will be the level of malondialdehyde (a     plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.   "
182105|NCT00219869|"     Most patients with CPTH present with additional major cognitive, behavioral and somatic     problems. Most drugs used currently have a negative influence on cognition. Therefore,     treatment strategies addressing both the headache and cognitive disturbances in patients with     CPTH are necessary. (CPTH; Chronic Post Traumatic Headache).   "
182106|NCT00219882|"     The purpose of this study is to assess the safety of advancing doses of curcuminoids     administered orally for fourteen consecutive days in adult subjects with cystic fibrosis (CF)     who are homozygous for ΔF508 CFTR.   "
182107|NCT00219895|"     Specific Aim: To determine whether neutrophils, active elastase, and cytokines measured in     sputum induced using hypertonic saline are useful screening tests for determining if a     particular agent with known anti-inflammatory properties is a suitable candidate for more     extensive clinical trials in patients with CF. This aim will be addressed using an     anti-inflammatory agent, ibuprofen, that has been shown to have clinical benefit in CF. A no     treatment arm will be included as the control group.   "
182108|NCT00219908|"     The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone     and interferon beta1b can delay disease progression of at least one point on EDSS scale in     patients with clinically very active relapsing-remitting multiple sclerosis.   "
182109|NCT00219921|"     There are several treatments for postoperative pain after Hip Replacement Surgery. However,     some require an intravenous line which may interfere with rehabilitation after surgery. This     study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery.     Patients will either receive pain treatment at surgery, continuous intravenous pain     treatment, or both. In the first two days after surgery, patients will frequently be asked to     rate their pain, and use of other pain medication will be monitored.   "
182110|NCT00219934|"     Group A: Long-term follow-up is needed for subjects identified as acute or early in the     course of HIV-1 infection, independent of decisions regarding therapy with highly active     anti-retroviral therapy (HAART).      Group B: This protocol will also be offered to subjects who were diagnosed with acute HIV-1     infection in the past and have been participating in an ADARC/Rockefeller University Hospital     treatment protocol for acute HIV-1 infection, and currently have a viral load consistently     less than 50 copies/ml on current treatment (Group B)   "
182111|NCT00219947|"     To study the collection of blood from individuals known to be at high risk for HIV-infection     or who have been recently infected with HIV.      The data collected are used for diagnostic, prognostic and management decisions as outlined     by current HIV-1 Treatment Guidelines.   "
182113|NCT00219973|"     The aim of the study is to evaluate the efficacy and safety of Bemiparin, a second-generation     LMWH, in the prophylaxis of VTE (using a postoperative regimen, i.e. administering the first     dose 6 hours after finishing the surgical procedure) for 28 days compared to 8 days, in     oncological surgery.   "
182114|NCT00219986|"     Monoclonal antibody infusions will prevent rebound of viremia in well-suppressed     HAART-treated individuals who began therapy during acute and early HIV-1 infection.   "
182115|NCT00219999|"     The purpose of this study is to measure specific chemokines, antibodies, and     antibody-producing B cells in the blood of patients with hepatitis C virus (HCV) infection.     Our hypothesis is that changes in chemokine levels affect the development of an effective     immune response against HCV.   "
182116|NCT00220012|"     This study looks at the effect of folate supplementation and depletion on the blood cells and     the colorectal cells. To examine the effect of these changes, blood samples and colorectal     biopsy samples are collected. The genetic material (RNA and DNA) is examined to see what     changes occur during the depletion and supplementation of folate. The hypothesis is that     folate may help prevent colon cancer   "
182117|NCT00220025|"     This study offers narrowband UVB light therapy to patients with both light and dark skin     types who have 10% of their body involved with psoriasis vulgaris.   "
182118|NCT00220038|"     The ability to smell varies greatly between different individuals. Some people are unable to     detect an odor that most people can smell. It is not known what causes these individual     differences. Humans have about 1000 genes for odorant receptors that bind and detect odor     molecules. It has been shown that some of these genes exist in two forms: a functional one     and one that has been mutated and is therefore no longer functional. We think that people who     can not smell a specific odor may carry the non-functional form of the gene for the receptor     that detects the odor molecule. To test this hypothesis we want to find people who can not     detect a specific smell and then compare their odorant receptor genes with those of people     who can smell the odor.   "
182119|NCT00220051|"     To assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by     capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the     treatment of patients with locally advanced or inoperable rectal cancer.   "
182120|NCT00220064|"     The objective of this study is to assess the efficacy and toxicity of a 2 weekly regimen     containing irinotecan combined with leucovorin-modified 5-fluorouracil in the setting of     relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or     metastatic adenocarcinoma originating from the oesophagogastric junction, stomach or pancreas     who have previously received chemotherapy and have either failed to respond or who have     relapsed after an initial response will be eligible for treatment in this study.      The response rate, failure-free survival and overall survival of treated patients with the     two different regimes will be evaluated. Toxicity and quality of life will also be monitored     closely.   "
182121|NCT00220077|"     Knowledge of the impact of gene expression profiling could allow optimisation of chemotherapy     regimens for individual patients. It could ensure that patients do not receive a particular     form of chemotherapy if it is unlikely to benefit them, and in these circumstances an     alternative form of chemotherapy that may prove beneficial could be selected. This     information will therefore allow chemotherapy to be tailored to the individual tumour. It may     help identify those patients with a poorer prognosis who could be selected for further     therapy post surgery or a different treatment strategy at the outset.   "
182144|NCT00220376|"     This trial will provide long-term data on safety, satisfaction and maintenance on therapy of     fesoterodine (SPM 907) in subjects with overactive bladder syndrome.      Subjects completing the 12 week treatment period of SP584 had the opportunity to participate     if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the     dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which can be     followed on an annual basis.      The primary variables are long-term safety and tolerability, measured by observation and     assessment of adverse events and duration on therapy. Further safety variables include the     assessment of laboratory parameters, changes in ECG, physical exams and measurement of     residual urine.      Secondary efficacy variables included various parameters derived from micturition diaries and     the evaluation of Quality of Life questionnaires   "
182246|NCT00228813|"     The purposes of this study are:        -  To examine the engraftment rate in patients receiving in vivo T-cell-depleted G-CSF          stimulated bone marrow from partially mismatched related donors.        -  To evaluate the incidence and severity of acute and chronic graft-versus-host disease in          patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially          mismatched related donors.   "
182122|NCT00220090|"     Irritable Bowel Syndrome (IBS) is the most commonly identified functional gastrointestinal     disorder, affecting 10-20% of the population in the Western world, seen predominantly in     females and with a negative impact on quality of life, characterized by recurrent and often     disabling abdominal pain associated with altered frequency or appearance or passage of the     stool.      IBS aetiology is unknown and its treatment remains largely empirical and directed to the     relief of symptoms. One possible target for IBS treatment has been identified in drugs that     modulate the action of Cholecystokinin (CCK), a peptide gut hormone implicated in the     regulation of motor and sensory functions at various levels of the gastrointestinal tract.      The biological actions of CCK in the gastrointestinal tract are mediated by CCK1-receptors.      Dexloxiglumide is an oral potent and selective antagonist of CCK1-receptors. The mechanism by     which dexloxiglumide might be beneficial in IBS is its ability to modulate visceral     hypersensitivity and gut dysmotility.      The DARWIN study has been designed to confirm the efficacy of dexloxiglumide according to a     so-called randomized/withdrawal design. In this design all participants start the study     treatment and only improved patients (the responders) are randomized to active treatment or     placebo, expecting a more frequent and/or a more rapid relapse of their symptoms in patients     randomised to placebo than those on active.      Female and male patients, aged 18-70 yrs meeting IBS diagnostic criteria whose main complain     is constipation, with a disease of at least moderate severity, will receive dexloxiglumide or     placebo during a double-blind treatment phase of 24 weeks, following a first treatment of up     to 12 wks during which patients will have to qualify as responders to the study treatment.      The responder status of each patient over each 4-wk assessment period, will be based on a     weekly global patient-based assessment of relief and control of symptoms using a     telephone/internet-based diary.      Additional secondary efficacy parameters will include: effect of treatment on IBS cardinal     symptoms (e.g. abdominal discomfort/pain, bloating, straining, incomplete evacuation,     urgency, stool frequency and consistency), on rescue laxative consumption, and on quality of     life.      Standard safety parameters include vital signs, adverse event reporting, physical     examination, routine laboratory screen, 12-lead ECG and gallbladder ultrasound.   "
182123|NCT00220103|"     To investigate the efficacy and safety of epirubicin, cisplatin and capecitabine as     neoadjuvant therapy prior to radical resection in patients with newly diagnosed operable     oesophageal adenocarcinoma.   "
182124|NCT00220116|"     To assess the efficacy and safety of the combination of capecitabine and oxaliplatin in the     1st, 2nd or subsequent line treatment of metastatic colorectal cancer, and also in the     neo-adjuvant and adjuvant setting of resectable metastases.      Primary Endpoint: Objective response rates      Secondary Endpoints: Treatment related toxicity Progression free survival (If not resected)     Disease free Survival (From metastastectomy, if resected) Overall Survival 60 Day all cause     mortality Number undergoing liver resections/curative resection (Ro) rate   "
182125|NCT00220129|"     This is a study to investigate the efficacy and safety of epirubicin, cisplatin and     capecitabine (ECX) as neoadjuvant therapy prior to radical chemoradiotherapy using     capecitabine and cisplatin as radio-sensitisers in patients with newly diagnosed localized     squamous cell carcinoma of the oesophagus.   "
182126|NCT00220142|"     To correlate the molecular profile of a series of defined CRCs with prognosis and toxicity.   "
182127|NCT00220155|"     To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous     infusion in patients with pretreated metastatic colorectal cancer.   "
182128|NCT00220168|"     The objective of this study is to assess the efficacy and toxicity of a 3 weekly regimen     containing irinotecan combined with capecitabine in the setting of relapsed or refractory     upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma     or squamous cell carcinoma originating from the oesophagus, oesophagogastric junction or     stomach who have previously received chemotherapy and have either failed to respond or who     have relapsed within 3 months after an initial response will be eligible for treatment in     this study.      The response rate, failure-free survival and overall survival of treated patients will be     evaluated. Toxicity and quality of life will also be monitored closely.   "
182129|NCT00220181|"     Symptoms such as diarrhoea and abdominal discomfort are common side effects of radiotherapy     for tumours in the pelvis and usually occur within 2 weeks of starting treatment. Once the     course of radiotherapy has been completed these symptoms usually subside, but in some     patients they may continue and sometimes cause significant problems.      It is not clear what processes are occurring to trigger such symptoms. There are a number of     possibilities and we would like to investigate these further. If we can identify specific     reasons for symptoms being worse in one patient compared to another, then we can try to     either prevent or treat these. The aim of this study is to look for differences in the way     that the bowel adapts to radiotherapy in patients who do and those who don't experience bowel     symptoms during their course of radiotherapy.   "
182130|NCT00220194|"     Comparing the effect of switching from Lupron and Zoladex to Eligard. PSA and Testosterone     levels are measured at set intervals to determine if Eligard is equal or better then Lupron     or Zoladex in advanced Prostate Cancer patients.   "
182131|NCT00220207|"     This grant supports a 12-month randomized controlled trial comparing usual care versus     collaborative disease management over the Internet among disadvantaged African-Americans with     Type 2 diabetes. The project aims to: (1) determine the effect of case-managed, Web-based     diabetes care on glycemic control, health care utilization, self-efficacy, and patient     satisfaction; and (2) qualitatively identify enablers of the successful use of computers, the     Internet, and e-Health applications by disadvantaged patients.   "
182132|NCT00220220|"     Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive     patients whose blood pressure is not adequately controlled with olmesartan alone.   "
182133|NCT00220233|"     This study is to test the efficacy and safety of the combination of olmesartan and amlodipine     in hypertensive patients whose blood pressure is not adequately controlled with amlodipine     alone   "
182134|NCT00220246|"     Two major genetic pathways leading to colorectal carcinoma can well be distinguished; the     'suppressor pathway', which is characterized by inactivation of tumor-suppressor genes and     the 'mutator pathway', which is characterized by microsatellite instability. The purpose of     this study is to explore a third putative pathway; microsatellite and chromosome stable     colorectal cancer where an alternative cancer-causative mechanism might play a role.   "
182166|NCT00220662|"     This research examines the efficacy of a 5-session individual psychotherapy intervention     designed to enhance readiness and motivation for change in individuals with anorexia nervosa,     bulimia nervosa, and eating disorder not otherwise specified.      It is hypothesized that individuals randomly assigned to receive Readiness and Motivation     Therapy (RMT) will have higher readiness and motivation scores and improved eating disorder     and psychiatric symptomatology following the intervention than individuals assigned to a     no-treatment control condition.   "
182167|NCT00220675|"     To determine whether erythropoietin, steroids and radiotherapy is safe and feasible to     administer to patients with malignant spinal cord compression.   "
182135|NCT00220259|"     The overall aim of this study is to find out whether taking regular inhaled steroids (eg     Pulmicort, Flixotide, Becotide, Becloforte) is good for the lungs of children and adults with     cystic fibrosis (CF).      Some patients are put on inhaled steroids because they are wheezy despite taking regular     bronchodilators (inhaled medicines that help open up the airways eg Ventolin, Bricanyl).     Occasionally young children are put on them when they wheeze with colds, and have simply     remained on them ever since. However many CF patients have been put onto inhaled steroids     because their doctors thought it might reduce the inflammation in the lungs and help improve     lung function. This inflammation (which is swelling of the lining of the airways) is known to     be important in CF and results from recurrent chest infections.      Although it is believed, in theory, that inhaled steroids should be useful for most CF     patients, we are not sure how well they work in CF and it has not yet been possible to prove     this with standard studies. This would normally involve starting inhaled steroids in patients     who have not been taking them. We have therefore taken a different approach, namely to     withdraw them from some patients who have been on them for a long time, to see if there is     any effect of stopping them.      It is important that we answer this question, as we do not want CF patients taking medicines     that may be unnecessary. CF patients already have to take many oral and inhaled medicines and     if we can cut down this burden, it would be helpful for everyone. Of course, we may find that     patients do need these medicines but at least we will then be certain that it is for a good     reason.      The main hypothesis is that withdrawing inhaled steroids is not associated with an earlier     onset of acute chest exacerbations.   "
182136|NCT00220272|"     -  The primary objective is to study the effect of SR57667B at the dose of 4 mg/d on          progression of dopaminergic nigro-striatal lesions assessed by 18F-Dopa PET imaging.        -  Secondary objectives are to assess the effect of SR57667B on symptomatic decline in          patients with early PD, to assess the safety/tolerability of SR57667B in patients with          early PD and to document plasma concentrations of SR57667 in patients with early PD.   "
182137|NCT00220285|"     The purpose of this study is to investigate the antitumor effect and safety of the product     for relapsed or refractory indolent B-cell non-Hodgkin's lymphomas.   "
182138|NCT00220298|"     This study will evaluate the preparation of testosterone undecanoate under conditions which     resemble real-life situations.   "
182139|NCT00220311|"     The purpose of this study is to confirm the efficacy and safety of fludarabine phosphate     administered with dose increasing in 6 cycles (1 cycle: 5 treatment days every 28 days) in     untreated chronic lymphocytic leukemia (CLL) patients with anemia and/or thrombocytopenia.   "
182140|NCT00220324|"     The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and     safety of SH D00342A. Subjects participating in the study will be treated with an oral     contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.   "
182141|NCT00220337|"     The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a     longer period of time and whether it continues to work well to treat pain.      Subjects will receive lacosamide at a dose that will be individually determined to be the one     that provides most pain relief with the least side effects. The maximum dose will be     600mg/day. Subjects may participate in this trial until October 2007. This time may be     extended to allow them to participate until lacosamide is commercially available.      If a subject meet the requirements for the study at Visit 1 and after a two weeks phase     without trial medication, s/he enters a Titration Phase to determine the personal optimal     dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will     be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks     thereafter.   "
182142|NCT00220350|"     This study compared cognitive-behavioral psychotherapy with leuprolide acetate (LA) to     cognitive-behavioral psychotherapy with saline injections for 12 months. Five white male     pedophiles (M age, 50 years; range, 36-58) volunteered for a two-year study. LA was     administered by Depo injection (7 mg initially, then 22.5 mg every 3 mos) for 12 months,     followed by saline placebo. Effects of LA on testosterone levels, sexual interest preference     by visual reaction time (Abel Assessment), penile tumescence (Monarch PPG), as well strong     urges and masturbatory frequency to children (polygraph), were measured every three months.     Subjects were treated with weekly cognitive-behavioral psychotherapy. On LA, testosterone     decreased to castrate levels. Because of the suppression of testosterone, physiologic arousal     response as measured by penile plethysmography (penile tumescence) was significantly     suppressed compared with baseline. However, sufficient response remained to detect pedophilic     interest. This pedophilic interest was also detected by visual reaction times. All subjects     self-reported a decrease in strong pedophilic urges and masturbation. When asked about having     pedophilic urges and masturbating to thoughts of children, polygraph responses indicated     subjects were not deceptive when they reported decreases. On placebo, testosterone and     physiologic arousal eventually rose to baseline levels. At baseline and on placebo, subjects     were consistently deceptive regarding increased pedophilic urges and masturbatory frequency     as noted by polygraph. Interest preference, as measured by Abel Assessment and Monarch PPG,     was generally unchanged throughout the study. Cognitive-behavioral psychotherapy augmented     with LA significantly reduced pedophilic fantasies, urges, and masturbation, but did not     change pedophilic interest during one year of therapy. Deceptive responses by polygraph     suggested that self-report was unreliable. Follow-up utilizing objective measures is     essential for monitoring efficacy of treatment in pedophilia. Our study supports the     supposition that modification of pedophilic behavior is possible. LA may augment     cognitive-behavioral psychotherapy and help break the sequence leading to a reoffense.   "
182143|NCT00220363|"     The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2     week Safety Follow-Up period. Subjects were randomized to one of 4 treatment arms receiving     either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or     placebo during the Double-Blind Treatment Period.      Two primary efficacy variables will be assessed for submission in the United States: change     in the average number of micturitions (frequency) per 24 hours and the change in the average     number of urge incontinence episodes per 24 hours. For the submissions in the European Union,     the first primary variable will be the change in the average number of micturitions     (frequency) per 24 hours and the co-primary variable is the treatment response, based on a     treatment benefit scale. All continuous variables will be measured as changes from baseline     to value after 12 weeks of treatment.      The most important safety variables included the assessment of adverse events, laboratory     parameters, changes in ECG, physical exams and measurement of residual urine.   "
182168|NCT00220688|"     Randomised controlled trial of acupressure wrist bands for hospice in-patients suffering from     terminal cancer who are troubled by nausea and vomiting.   "
182169|NCT00220701|"     This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of     dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.      It is hypothesized that Escitalopram will be superior to placebo in improving depression, as     well as psychosocial, temperamental, and cognitive functioning.   "
189216|NCT00315601|"     The major objectives of this research are to see how much, and for how long, telithromycin     and azithromycin get into the fluids and cells of the lung.   "
182145|NCT00220389|"     This extension trial of SP668 consists of two phases: double-blind treatment and open-label     extension. The trial provides subjects the option of long-term treatment with sustained     release (SR) fesoterodine (SPM 907) and to assess long-term subject safety, tolerability and     efficacy.      Double-Blind: Subjects remained on either fesoterodine 4mg, 8mg or 12mg depending on their     dose assignment in SP668. Previous SP668 placebo subjects received fesoterodine 4mg.      Open-Label: Subjects received fesoterodine 8mg with a one time option to reduce the dose to     4mg and a one time option to increase again to 8mg.      The primary variables focus on long-term safety and tolerability and include the observation     and assessment of adverse events, residual urinary volumes, laboratory parameters, changes in     ECG, physical and urological examinations and subject's assessment of treatment tolerance.      Secondary efficacy variables include various parameters derived from micturition diaries,     count of subjects and their dose choice throughout the trial and subject's assessment of     treatment efficacy.   "
182187|NCT00220935|"     Hypothesis – This study is designed to evaluate the results of using the Orthotrac Pneumatic     Vest versus an EZ form brace in patients with radiating leg pain from disc bulge / protrusion     / herniation. Specifically, our hypothesis is that patients given the Orthotrac Pneumatic     Vest (OPV) will have greater pain relief and increased self-reported functionality and fewer     progressions to surgery than those using the EZ form brace.   "
191644|NCT00353509|"     Prospective mono-center clinical study to evaluate the safety and effectiveness of an     intracardiac septal closure device in patients with atrial septum defect (ASD)   "
182146|NCT00220402|"     This trial will provide long-term data on safety, satisfaction and maintenance on therapy of     fesoterodine (SPM 907) in subjects with overactive bladder syndrome.      Subjects completing the 12 week treatment period of SP583 had the opportunity to participate     if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the     dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which could be     followed on an annual basis.      Two primary efficacy variables will be assessed, which are observation and assessment of     adverse events and duration on therapy.      Secondary efficacy parameters included various parameters derived from micturition diaries     and the evaluation of Quality of Life questionnaires (KHQ and ICIQ-SF).      The most important safety variables included the assessment of adverse events, laboratory     parameters, changes in ECG, physical exams and measurement of residual urine.   "
182147|NCT00220415|"     Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with     partial seizures and are taking up to 3 medications for this medical condition will take part     in this research study at approximately 80 different locations in Australia and Europe.      The purpose of this study is to evaluate the effectiveness, safety and tolerability of     consistent dosages of study drug (lacosamide) taken orally twice a day for about 4 months.      Each patient who qualifies and chooses to participate in the study will receive placebo     (inactive drug) or gradually increasing doses of lacosamide (SPM 927) up to the target dose     of 200mg/day or 400mg/day. The target dose or placebo will be maintained for 12 weeks.      The study clinic visits will include a medical history and physical exam, ECG, blood and     urine sample collection, and completion of a seizure diary.      Patients who complete the study may enroll in an extension trial and receive active study     drug.   "
182148|NCT00220428|"     The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients.   "
182149|NCT00220441|"     The specific aims for the study will be to determine if aerobic exercise enhances cognition     for older adults who are at risk for developing type II diabetes mellitus (T2DM), and to     evaluate whether change in insulin sensitivity predicts cognitive performance for subjects     randomized to the aerobic exercise group. Sedentary older adults diagnosed with impaired     glucose tolerance using an oral glucose tolerance test will participate in a 6-month     supervised protocol of either aerobic exercise or stretching. Cognitive testing and blood     collection will occur at baseline, and months 3 and 6. Before and after the 6-month     intervention, insulin sensitivity, maximum aerobic capacity, and body fat composition and     distribution (via CT scan) will be assessed for all subjects. The results of this study may     provide support for a relatively simple and inexpensive treatment strategy that specifically     targets many of the health factors that directly influence risk of cognitive decline     associated with T2DM for older adults.   "
182150|NCT00220454|"     The study tests the hypothesis that estradiol administration exacerbates the effects of the     stress hormone cortisol on cognition and mood for postmenopausal women. This randomized,     placebo-controlled, double-blind study was designed to examine the effects of an eight-week     trial of transdermal estradiol replacement therapy (0.10 mg/day) in combination with 4 days     of oral hydrocortisone (90 mg/day in 3 daily doses of 30 mg per dose) in the last week of     hormone therapy on cognition and mood in healthy postmenopausal women. Forty cognitively     healthy postmenopausal women were randomized to receive either placebo or estradiol skin     patches for 8 weeks. In the middle of the 7th week (day 57), subjects in each group were     again randomized to receive either a placebo tablet or an oral hydrocortisone tablet 3x/day     for 4 days. Memory testing and blood collection occurred at baseline, at week 4, and again at     week 8.   "
182151|NCT00220467|"     The specific aims for the study will be to determine if aerobic exercise enhances cognition     for older adults who are at greater risk for developing Alzheimer's disease, and to evaluate     whether change in insulin sensitivity predicts cognitive performance for subjects randomized     to the aerobic exercise group. Sedentary older adults diagnosed with mild cognitive     impairment will participate in a 6-month supervised protocol of either aerobic exercise or     stretching. Cognitive testing and blood collection will occur at baseline, and months 3 and     6. Before and after the 6-month intervention, insulin sensitivity, maximum aerobic capacity,     and body fat composition and distribution (via CT scan) will be assessed for all subjects.     The results of this study may provide support for a relatively simple and inexpensive     treatment strategy that specifically targets many of the health factors that directly     influence risk of cognitive decline for older adults.   "
182152|NCT00220480|"     The primary objective of this multicenter study is to evaluate the efficacy of escitalopram     in treatment resistant depression (TRD), assessed by 2 consecutive failed antidepressant     treatments from different classes. The last treatment received is a 6 week prospective trial     with venlafaxine.   "
182153|NCT00220493|"     Scientific background:      Growing awareness and accumulating data regarding the cognitive impairment and its     progression in multiple sclerosis (MS) patients has received an important place in     neurological research in the last decade.   "
182154|NCT00220506|"     To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS     Patients   "
182262|NCT00229268|"     The purpose of this study is to determine whether the level of FOXA2 expression in fat tissue     is a biomarker of insulin resistance. To test this hypothesis, we will perform     euglycemic-hyperinsulinemic clamps in normal and obese human subjects to calculate insulin     sensitivity, and see if insulin sensitivity correlates with the FOXA2 expression in     subcutaneous fat.   "
182155|NCT00220519|"     Critical illness and the therapies that accompany it are associated with a disruption in the     ecological equilibrium of the GI tract that can ultimately lead to infection. Lactobacillus     GG, a probiotic, replenishes the healthy flora of the intestinal tract and may decrease the     risk of diarrhea and infection during critical illness. However, little is known about the     impact of probiotics following a burn injury and the mechanisms behind the proposed benefits.     The hypothesis of this research is that Lactobacillus GG decreases the incidence of diarrhea     and infection in burned children receiving antibiotic therapy. The specific aim of this     research is to determine the impact of Lactobacillus GG on the incidence of diarrhea and     infection among burned children (>20% TBSA) receiving antibiotic therapy.   "
182156|NCT00220532|"     This is a randomised double-blind placebo-controlled trial to see whether giving a low dose     of the vitamins folic acid and riboflavin is beneficial to women who have very low grade     abnormalities of the cervical cells.   "
182157|NCT00220545|"     Laparoscopic ovarian diathermy (LOD) is currently offered to infertile women with polycystic     ovarian syndrome (PCOS) who fail to conceive on clomiphene citrate (CC). However, using LOD     before CC may result in a better reproductive outcome since LOD may reduce risks associated     with CC such as miscarriages and multiple pregnancies. The aim of the study is to evaluate     the effectiveness of LOD and its potential value in improving the success rates in infertile     women with PCOS. This study will recruit 72 women with PCOS suffering from infertility due to     lack of ovulation from the infertility clinic. After initial assessment, patients will be     given explanation about the study and will receive an information leaflet. They will then be     randomized into two groups: Group1 (36 patients) will receive CC as per infertility clinic     protocol to induce ovulation for up to 6 months. Group 2 (36 patients) will undergo     laparoscopic ovarian diathermy under general anaesthetic. Blood samples will be taken from     both groups before any treatment, shortly after treatment and at 3 and 6 months after     treatment to measure various hormones. Patients will be contacted every month after treatment     for follow up. The reproductive outcomes particularly the pregnancy and livebirth rates will     be compared between the two groups.   "
182158|NCT00220558|"     The objective of this study is to compare the Cypher Select-TM Sirolimus Eluting Stent (SES)     with the SONIC-TM Bare Metal Stent (BMS) in the treatment of Chronic Total Occlusion lesions     (CTO). The primary hypothesis is that, at 8-month follow-up, the minimal luminal diameter     (MLD) of the coronary segment treated with stent implantation in CTO lesions is significantly     larger with the use of SES compared to BMS. The treated segment is defined as the segment     covered by the stent(s) plus 5 mm proximally and distally to the stent(s).   "
182159|NCT00220571|"     The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted     to hospitals with no PTCA facilities is to compare the effects on clinical outcome and     cost-effectiveness of two reperfusion strategies:        -  Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of          lack of reperfusion        -  Elective referral for “facilitated” PTCA after early administration of Abciximab and          half dose of Reteplase   "
182160|NCT00220584|"     Fragile X syndrome is the most common known inherited cause of neurodevelopmental disability.     Functional magnetic resonance imaging (fMRI) studies from our laboratory indicate that     specific brain regions using the neurochemical, acetylcholine, show significantly reduced     activation during learning. Since donepezil is a medication that enhances acetylcholine     function in the brain, the purpose of this study is to determine if donepezil has any     beneficial effect on behavior or cognition in subjects with fragile X syndrome.   "
182161|NCT00220597|"     This study will evaluate the effectiveness of trauma-focused group therapy for reducing     HIV-risk behavior and revictimization among adult women survivors of childhood sexual abuse     (CSA).   "
182162|NCT00220610|"     Subjects received rTMS daily on 10 consecutive weekdays (five sessions per week), during 20     minutes per session.During the rTMS session, the coil was centered flat over the right     parietal cortex.      We follow the patient during 12 weeks after the 2 weeks of tms (follow-up period) to measure     the depression with different rating scales.      We hypothesized that rTMS has a positive effect in the treatment of depression   "
182163|NCT00220623|"     Major Depressive Disorder affects approximately 16% of the adult population over the     lifetime. Controlled studies indicate that short-term antidepressive medications or     psychotherapy produce full remission in only about 46% of patients. Furthermore, about 80% of     patients will continue to have subsequent recurrences after remission of the first episode,     with each episode increasing the probability of future recurrences. This pilot study will     examine whether antidepressive medications plus one of three commonly available types of     psychotherapy used in the short-term treatment of depression can protect against the     recurrence of depression if active treatment is extended to 18-months duration. Results will     aid designing a more complete study.      Adults with an acute episode of major depressive disorder with at least one prior episode     will be randomized to Antidepressive medications (ADM) plus 18-months of either     Cognitive-behavioral therapy (CBT) or Dynamic psychotherapy (DYN), or to a standard control     therapy, Supportive Clinical Management (SUP-CM). We will determine whether a higher     percentage of those receiving either CBT or DYN remain well after three years of follow-up,     compared to those receiving the standard control treatment. We will also examine the     reduction in psychological risk factors as well as potential economic benefits of the three     approaches.   "
182164|NCT00220636|"     This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical     antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI)     antidepressant treatment for depressed outpatients who are not responding fully to SSRI     treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of     treatment with Aripiprazole and SSRI medication.   "
182165|NCT00220649|"     The purpose of this trial is to determine the maximum tolerated dose and the dose-limiting     toxicity of biweekly oxaliplatin in combination with fixed doses of irinotecan,     5-fluorouracil/leucovorin and gemcitabine in patients with metastatic solid tumors or     adenocarcinoma of the pancreas.   "
182263|NCT00229281|"     Assessing Anxiety in patient suffering from anxiety disorders (NOT OCD or PTSD)before and     after group therapy   "
182264|NCT00229294|"     Assessing FM and psychiatric state among PTSD, MDD and healthy participants   "
182265|NCT00229307|"     Comparing the efficacy of 40 minutes PE treatment to 20 minutes of the same treatment   "
182185|NCT00220909|"     The primary objective of this study is to determine whether lansoprazole, administered     intravenously, can protect patients undergoing cardiac surgery from the development of and/or     progression of previously undetected acid/peptic disorders (erosive esophagitis, gastric     ulcer, duodenal ulcer, diffuse gastritis, duodenitis) as measured by the Lanza score and LA     classification for esophageal injury.      The secondary objectives of this study are:        1. To determine if intravenous lansoprazole protects against the development of clinically          important gastrointestinal bleeding in this population (overt bleeding or requiring          blood transfusion).        2. To determine if intravenous lansoprazole maintains the intragastric pH above that for          placebo throughout the study period.   "
182186|NCT00220922|"     This study is designed to compare injection site reactions with or without the use of alcohol     wipes prior to performing the patients' daily Copaxone® injection.   "
182170|NCT00220714|"     Many patients who have recently received a diagnosis of schizophrenia (e.g., first-episode     schizophrenia) respond very well to their antipsychotic medication when they are acutely     ill. Once they are more stable, research has shown that first-episode patients need to remain     on their antipsychotic medication. Follow-up studies show that stopping medication     prematurely is the most common cause of relapse and readmission. It is important to have new     ways to help patients stay stable in the community in order for them to continue on with     their rehabilitation and recovery process.      Over the last decade, new antipsychotic medications have been developed that are more     effective and have fewer side effects than older antipsychotics. The new medicines are often     called atypical, and were only available by pill or capsule for long-term treatment. Most     recently, one of the atypical medications - risperidone - became available as a long-acting     injection that can be given once every 2 weeks.      The hypothesis of this study is that patients recovering from an acute episode and who then     go on to receive a long-acting version of atypical antipsychotic medication (long-acting     risperidone microspheres) will stay on their medications for longer than those who take their     atypical medication (any available first-line atypical) in the oral (pill) form.   "
182171|NCT00220727|"     The objective of this study is to determine if the safety and tolerability of Immune Globulin     Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at     two different infusion rates.   "
182172|NCT00220740|"     The intent of this study is to demonstrate the efficacy and safety of Immune Globulin     Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously     diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur     every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and     Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and     month 6 will receive the alternate study drug for an additional 6 months.   "
182173|NCT00220753|"     The purpose is to find out if Icleen IQAir, HEPA-filter air cleaners with high capacity and     pre-set speed functions, have a beneficial effect on patients with asthma and allergy to     dogs.      Air cleaners will be installed in the bedrooms and living rooms in the homes of children and     adolescents aged 8-17 years at the study entry, with allergy to dogs, but not to house dust     mites.      The investigators will look upon the significance of this study, and of a previous study with     a similar design and the same main parameters to find out if this trial supports the results     of the first trial by the same project leader, or makes it likely that the seemingly     beneficial effects of the first study occurred by chance.      Main parameters:        -  hyperventilation cold air challenge test      Supportive parameters:        -  serum ECP        -  symptom scores      The trial will be a parallel, double blind placebo controlled one.   "
182174|NCT00220766|"     The objective of this study is to determine if the safety and tolerability of Immune Globulin     Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at     two different infusion rates. The primary objective is to compare the incidence and severity     of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14     mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.   "
182175|NCT00220779|"     The trial will study 2 doses of Immune Globulin Intravenous (Human), 10%     Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year     treatment period.   "
182176|NCT00220792|"     The purpose of this study is to determine whether women with primary breast cancer who were     randomly assigned to receive a brief group therapy would show a greater reduction in mood     disturbance over time compared to those randomized to the control condition. We also     hypothesized that women who were highly distressed at baseline would show the greatest     benefit from participating in a support group, and that therapists with more training and     experience would be most effective in reducing distress.   "
182177|NCT00220805|"     This study will evaluate visual improvement in patients treated with Immune Globulin     Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) or placebo who have     Age-Related Macular Degeneration (AMD) with occult Choroidal Neovascularization (CNV).   "
182178|NCT00220818|"     The purpose of this study is to understand how quickly lansoprazole, once daily (QD),     improves feeding in premature babies or babies less than 28 days of age.   "
182179|NCT00220831|"     The purpose of this study is to determine whether Vitamin E treatment to Diabetic patients,     who carry the Haptoglobin 2-2 Phenotype, prevents cardiovascular complications such as acute     MI and Stroke.   "
182180|NCT00220844|"     The purpose of this study is to determine the effects of two tricyclic antidepressant agents     (TCAs), amitriptyline and desipramine, on gastric emptying and gastric accommodation using a     newly developed scintigraphic test that simultaneously measures both gastric emptying and     gastric volume (accommodation). These two tricyclic antidepressant agents are commonly used     at low doses to treat patients with refractory functional dyspepsia.   "
182181|NCT00220857|"     To determine the effectiveness of rabeprazole in preventing or decreasing acute     gastroduodenal injury caused by therapeutic doses of aspirin in a placebo-controlled,     randomized, double-blind parallel group study.   "
182182|NCT00220870|"     The impact of a decision aid for inpatients with schizophrenia on perceived involvement and     compliance is studied in comparison with routine care.   "
182183|NCT00220883|"     The primary objective of this study is to determine whether EGG readings obtained from both     normal subjects and dyspeptic patients are reproducible from one EGG recording to another on     a different day.      The secondary objective of this study is to determine whether the EGG readings are analyzed     and diagnosed consistently when reviewed and compared by multiple blinded readers when the     same tracing is reviewed.   "
182184|NCT00220896|"     Patients undergoing hip or knee joint replacement at the age of 70 years or above who are     cognitively unimpaired will receive donepezil or matching placebo before (over 5-7 days),     during and after (over 7 days) surgery. The incidence of delirium will be monitored at 3     days, 7 days, and 49 days following surgery. We hypothesize that the incidence of delirium     can be lowered from 20 per cent to 10 per cent by the intervention.   "
182266|NCT00229320|"     Assessing OCD before and after group therapy   "
183517|NCT00245973|"     The purpose of the study is to investigate whether eight weeks of treatment with flexible     doses of Bifeprunox is superior to treatment with placebo in depressed patients with bipolar     disorder.   "
182188|NCT00220948|"     Hypothesis:      Myoelectric patterns observed from the CERSR array during standardized testing are sensitive     in identifying healthy subjects from patients with internal disc derangement and a positive     discogram. A positive CT discogram is defined as one following the Dallas discogram protocol     with abnormal disc morphology and reproduction of symptoms   "
182189|NCT00220961|"     The purpose of this study is to examine whether pioglitazone versus placebo can reduce the     conversion rate of impaired glucose tolerance (IGT) to type 2 diabetes mellitus   "
182190|NCT00220974|"     The purpose of this trial is to find out if a special website might help people discover if     they have high cholesterol and then enable them to manage their cholesterol more     appropriately. The primary aim of this trial is to determine the effects on consumers' use of     cholesterol lowering therapy of an online service that provides automated, individually     tailored, advice about eligibility for cholesterol lowering treatment. The primary null     hypothesis being tested is that the service will result in no change in the use of     cholesterol lowering treatments by consumers that use the service.      The secondary aim of the trial is to see if it is possible to improve the cholesterol     management of the friends or relatives of consumers that use the I-CAT service. The     corresponding secondary null hypothesis being tested is that the I-CAT service will result in     no change in the use of cholesterol lowering treatments by the friends or relatives of the     consumers that use the service.   "
182191|NCT00220987|"     The primary aim of the study is to compare the effects of the two blood glucose targets on 90     day all-cause mortality in Intensive Care patients who are predicted on admission to stay in     the ICU for at least one full calendar day. The hypothesis is that there is little difference     in the relative risk of death between patients assigned a glucose range of 4.5 - 6.0 mmol/L,     and those assigned a glucose range of less than 10.0 mmol/L with insulin being infused if     blood glucose exceeds 10.0 mmol/L, and adjusted when needed to maintain blood glucose of 8.0     - 10.0 mmol/L.   "
182192|NCT00221000|"     Rheumatoid arthritis (RA) is a systemic autoimmune inflammatory disorder that can cause     substantial pain and joint tenderness, significant joint damage, and serious disability. The     treatment goals are minimization of the signs and symptoms of the disease, and the reduction     of irreversible joint damage.      As the understanding of the pathophysiological mechanisms underlying RA is elucidated, the     opportunity to target specific inflammatory processes with new therapies has improved.     Rheumatoid arthritis is a T cell-mediated autoimmune disease and there are various therapies,     including newer experimental therapies, which target either the activation of T cells or the     neutralization of their effector mechanisms. These newer therapies have shown benefit in     human and animal models of RA. Extracorporeal photoimmune therapy (ECP) has been shown to be     safe and effective in the palliative treatment of the skin manifestations of cutaneous T cell     lymphoma. Experimental studies have also demonstrated activity of ECP treatment in several T     cell mediated diseases including graft versus-host disease, rejection after organ     transplantation, and selected autoimmune diseases.      This study will evaluate a cell-based therapy (ECP) in patients who have an inadequate     response to disease-modifying antirheumatic drugs (DMARDs) and biological agents to determine     if ECP treatment can reduce the signs and symptoms of RA in this refractory patient     population.   "
182193|NCT00221013|"     This study seeks to determine if increasing the dose of continuous renal replacement therapy     (CRRT) reduces 90-day all cause mortality in Intensive Care Unit (ICU) patients with severe     acute renal failure (ARF).   "
182194|NCT00221026|"     his study will explore the safety and activity of ECP treatment with UVADEX in inducing a     clinical response (i.e., a CDAI decrease greater than or equal to 100 from baseline and/or a     CDAI < 150) over a 12-week period in moderately active Crohn's disease (CDAI greater than or     equal to 220 to < 450) patients who are refractory or intolerant to immunosuppressants and/or     anti-TNF agents. This study will also assess response to continued treatment during a 12-week     Extension Period in patients who have a clinical response at Week 12 of the Treatment Period     and elect to participate in the Extension Period.   "
182195|NCT00221039|"     The study objective is to demonstrate that the UVADEX® Sterile Solution formulation of     methoxsalen used in conjunction with the UVAR XTS Photopheresis System can have a clinical     effect on the skin manifestations of CTCL (mycosis fungoides) in early stage disease.   "
182196|NCT00221052|"     Overweight increases the risk to develop chronic diseases including type-2 diabetes and     cardiovascular disease. The low-grade inflammatory status often seen in overweight subjects     is thought to play an important role in disease development.      The purpose of this study is to determine the role of inflammation on glucose metabolism and     insulin resistance. In this study the effect of the anti-inflammatory treatment diclofenac on     markers of inflammation and on parameters of glucose metabolism will be studied.   "
182267|NCT00229333|"     The goal of the present study is to compare the effectiveness of the active (S)-enantiomer of     citalopram, escitalopram with placebo in the treatment of patients with depressive syndrome     complicating Alzheimer’s dementia (AD), vascular dementia (VD) or mixed dementia (MD), for 8     weeks of double-blind treatment.   "
183518|NCT00245986|"     This study will evaluate the effects of genetics on metabolism of the anti-HIV medicine     efavirenz (Sustiva) and will see if Efavirenz interacts with bupropion (Zyban or Wellbutrin),     a drug commonly used to treat depression and to help people quit smoking. Efavirenz is     metabolized by an enzyme called CYP2B6, which is thought to be more active in some people     than in others, depending on their genetic makeup. The rate of metabolism of the drug can     affect how the body responds it and perhaps the ability of the HIV virus to develop     resistance to it.      Healthy volunteers between 18 and 55 years of age who are non-smokers and HIV-infected men     and women 18 years of age and older who are taking efavirenz along with two or three     nucleoside reverse transcriptase inhibitors may be eligible for this study. Candidates are     screened with a medical history and physical examination and blood tests, including tests to     determine which genes they have for four different proteins or enzymes (CYP2B6, CYP3A4,     CYP3A5, and MDR1) that metabolize drugs.      Participants are assigned to one of three groups for the following procedures:      -HIV-infected individuals: Blood samples are drawn to measure efavirenz levels, as follows:     On the last day of taking efavirenz, the subject skips his or her usual evening efavirenz     dose the night before sampling. The next morning at clinic, a catheter (flexible plastic     tube) is inserted into a vein in the subject's arm for collecting blood samples. After the     first sample is drawn, the subject takes a dose of efavirenz. Eight more blood samples are     collected at 1, 2, 4, 6, 8, 12, 24 and 48 hours after taking the efavirenz tablet. (The     catheter is removed after the 12-hour sample and the subject is discharged home, and then     returns to the clinic for the 24- and 48-hour samples, which are collected through a needle     inserted into an arm vein.) The subject returns to the clinic four more times for a single     blood draw at 7, 14, 21 and 28 days after stopping efavirenz.      HIV-infected patients whose HIV viral load reaches 1,000 copies/L or more within 12 months     after completing the study are asked to return to the clinic for a blood draw to check the     genotype of the virus for drug resistance.        -  Healthy Volunteers - Group 1: Blood samples are drawn to measure efavirenz levels, as          follows: Participants take one efavirenz tablet once a day for 13 to 15 days. On the          last day of taking efavirenz, the subject takes his/her last dose of efavirenz in          clinic, where blood is then collected as described above for HIV-infected individuals.        -  Healthy Volunteers - Group 2: A catheter is inserted into a vein in the subject's arm          and a blood sample is drawn through the catheter. The subject then takes a single          bupropion tablet and additional blood samples are drawn at 1,2, 2.5, 3, 3.5, 4, 6, 8,          12, 24 and 48 hours after the dose to measure the amount of drug in the blood. Subjects          begin taking efavirenz 0 to 6 days after the last bupropion blood level is measured. As          above, subjects will take one efavirenz tablet once a day for 13 to 15 days. On the last          day of taking efavirenz, a catheter is inserted into the subject's arm. Two blood          samples are drawn through the catheter, the subject takes the daily dose of efavirenz          along with a bupropion tablet. Eleven additional blood samples are drawn at 1, 2, 2.5,          3, 3.5, 4, 6, 8, 12, 24, and 48 hours after taking the pills to measure blood levels of          bupropion. Eight additional samples are collected at 1, 2, 4, 6, 8, 12, 24, and 48 hours          to measure efavirenz blood levels. (The catheter is removed after the 12-hour sample and          the subject is discharged home; the 24- and 48-hour samples are collected through a          needle inserted into an arm vein.)   "
182197|NCT00221065|"      Obstructive sleep apnea(OSA) is a sleep breathing disorder. When a person with OSA tries     to sleep the back of the throat closes and blocks the flow of air into lungs.When this     happens, a person's sleep is disrupted, causing minor awakenings(which the individual may not     recognize). This occurs many times throughout the night, causing poor sleep quality,excessive     daytime sleepiness, poor concentration, and sometimes depression.It is possible that poor     outcomes observed in stroke patients with OSA result from these neurocognitive phenomena,     presumably by reducing effective participation in rehabilitation activities.OSA is treated     with nasal continuous positive airway pressure(CPAP).CPAP therapy keeps the back of the     throat open so that airflow is never blocked.The study is designed to investigate whether     treatment of OSA with CPAP improves the results of rehabilitation.   "
182198|NCT00221078|"     Functional electrical stimulation (FES) is a process that uses low intensity electrical     pulses generated by an electric stimulator to create muscle contractions. By contracting     muscles in a specific sequence, one can generate various body functions such as grasping,     walking, and standing. Final goal of the study is to evaluate if FES training when applied     early during rehabilitation will help stroke patients to use their hands more effectively     after discharge from a rehabilitation facility, compared to those patients who have not     received FES training.   "
182199|NCT00221091|"     This study evaluates the efficacy of shunt operation for idiopathic normal pressure     hydrocephalus, and determines the diagnostic value of noninvasive procedures commonly     practiced in the clinic.   "
182200|NCT00221104|"     Although hyperlipidemia is not always the risk factor of stroke, inhibition of     3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke     in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol     lowering should be expected to attenuate inflammation and atherosclerosis. The present study     hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with     safety.   "
182201|NCT00221117|"     Functional electrical stimulation is a process that uses low intensity electrical pulses     generated by an electric stimulator to create muscle contractions. By contracting muscles in     a specific sequence, one can generate various body functions such as grasping, walking, and     standing.The study is designed to evaluate the effectiveness and long term benefits of     applying functional electrical simulation during early rehabilitation to improve grasping     function in persons who have suffered a spinal cord injury. By using functional electrical     stimulation,these patients could potentially improve their grasping function.   "
182202|NCT00221130|"     Adult periodontitis is a chronic infective disease affecting the periodontium. Periodontitis     induce the destruction of attachment apparatus of teeth, resulting in periodontal pocket     formation and teeth loss. This study will test the safety and efficacy of alveolous bone     reproduction by the transplantation of mixture named periodontium injectable gel for the     adult periodontitis patients. Injectable gel is the mixture of ex-vivo cultured mesenchymal     stem stem cells, ex-vivo cultured osteoblast-like cells differentiated from mesenchymal stem     cells and scaffold (include, platelet rich plasma, human thrombin and calcium chloride).   "
182203|NCT00221143|"     The purpose of this study is to determine if stem cell therapy with one's own cells     (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to     poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or     cure the leg wound.   "
182204|NCT00221156|"     The purpose of this study is to determine whether the intervention for newly diagnosed     abnormal glucose tolerance after coronary stenting will improve the long-term clinical     outcome.   "
182205|NCT00221169|"     Radiation therapy is an important part of the treatment for lung cancer when treatment intent     is for cure. Radiation is a local modality of treatment, that is, it only treats the area     that the radiation can target. Therefore it is critical to be able to visualize all the areas     of tumor involvement. With current imaging tests such as computed tomography scans (CT), the     scans may not be sensitive enough to detect all areas of cancer involvement but with newer     imaging tests, such as positron emission tomography (PET), the investigators may be able to     better target all the tumor that the CT scan may miss. There are two clinical trials being     conducted by the Ontario Clinical Oncology Group (OCOG)looking at PET in lung cancer. This     proposal is a companion study to the OCOG PET lung trials. In brief, this study will evaluate     the ability of CT alone versus combined PET CT imaging to determine the size of the tumor (or     gross tumor volume) along with the tiny extensions of cancer cells (or microscopic     extension). The gross tumor volume and its extension as determined by CT or PET CT will then     be compared to measurements made on the surgically removed tumor. Treatment with radiation     therapy must include all the gross tumor and its extension in order to be successful for     cure. If the radiation treatment does not treat all the identified tumor then the chance for     cure is lost. There have only been two previous reports of the ability of CT to determine the     gross tumor volume and its extension. There are no similar reports using PET CT. This study     will be the first of its kind to evaluate how accurate PET CT can be in detecting the gross     tumor and its microscopic extension using the surgically removed tumor measurements as the     gold standard. If PET CT is able to more accurately determine the tumor volume including its     microscopic extension, then this will help oncologists to better treat lung cancer using more     accurate radiation treatment volumes.   "
182206|NCT00221182|"     The purpose of this study is to determine if stem cell therapy with your own cells     (autologous cells) delivered with a catheter to regions of the heart with poor blood flow     will be safe and if it will relieve your chest pain, increase the blood flow, and/or improve     the cardiac contractility (function) by regenerating blood vessels in your heart.   "
182207|NCT00221195|"     The objective of this study is to assess whether prophylactic therapy with an activated     prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number     of bleeds in patients with hemophilia and persistent high responding inhibitors.   "
182208|NCT00221208|"     This study will investigate the biological and psychosocial benefits of a home-based     resistance-training program for sedentary, obese adults living with type 2 diabetes.   "
182217|NCT00221325|"     Rituximab is the first monoclonal antibody to receive approval in the treatment of cancer and     has been proven to lead to extended survival when administered intravenously in the treatment     of patients with systemic non-Hodgkin's lymphoma. We have previously demonstrated that a     small fraction of Rituximab administered intravenously is able to cross the     blood-brain-barrier into the brain.      We will test the idea that the direct injection into the cerebrospinal fluid of Rituximab, a     monoclonal antibody which attacks and kills lymphoma cells, is safe and when used in     combination with methotrexate in patients with recurrent brain and intraocular lymphoma.      We will also test the idea that the combination of rituximab plus methotrexate has activity     and is effective in the treatment of recurrent brain and intraocular lymphoma.   "
182268|NCT00229346|"     Assessing FM and psychiatric disorder in patients suffering from PMS or PMDD   "
182269|NCT00229359|"     Compare PTSD and non-PTSD subjects on several demographic, cognitive and military variables   "
182218|NCT00221338|"     This will be a double blind, placebo-controlled study of patients ≥65 years of age undergoing     surgery of the spine, hips and knees replacement at the University of California, San     Francisco (UCSF) Medical Center. Intraoperative anesthetic and postoperative pain management     will be standardized. Patients will be randomized to receive either placebo or gabapentin     preoperatively, and continued postoperatively until discharge. Intraoperative anesthetic and     other postoperative pain management strategies will be standardized. Postoperative delirium     will be measured using structured interviews. Cognitive function will be measured using a     battery of neurocognitive tests pre- and post-operatively. Using an intention to treat     strategy, we, the researchers at UCSF, will compare the amount of postoperative pain,     narcotic requirements, and postoperative delirium and cognitive dysfunction between the two     groups.   "
182276|NCT00229450|"     During perimenopause (the time just prior to menopause), women often notice many biological,     psychological, and social changes. In particular, some women experience depressive symptoms     during perimenopause that are severe enough to warrant antidepressant medication. Whether or     not women with perimenopausal depression respond to antidepressant medication may depend on     the level of estrogen in their blood. We would like to investigate whether estrogen will help     the women who only partially respond to antidepressant medications. We also want to examine     how different doses of estrogen may affect individuals differently.   "
182209|NCT00221221|"     Over 30 studies have shown that exercise can improve physical fitness, reduce fatigue,     increase functioning, and enhance overall quality of life (QoL) in breast cancer survivors     both during and after treatments. Research has also shown, however, that breast cancer     survivors experience a significant reduction in physical activity during treatments that is     not recovered even years after treatments are completed. The objectives of this study are to     examine the effects of two behavior change interventions (a step pedometer and printed     materials) on physical activity, social cognitive variables, and QoL in a population-based     sample of breast cancer survivors. Approximately 300 breast cancer survivors living in     Northern Alberta will be randomized to one of four groups: (1) an exercise recommendation     only group (viewed as the current standard of care), (2) an exercise recommendation plus     pedometer group, (3) an exercise recommendation plus printed materials group, and (4) an     exercise recommendation plus pedometer and printed materials group. Our primary hypothesis is     that participants receiving the combined pedometer and printed materials intervention will     report the greatest change in physical activity. Our secondary hypotheses are that these     interventions will also result in improved QoL and more positive social cognitive beliefs     about exercise in breast cancer survivors. Given the geographic dispersion of our population,     finding practical and sustainable interventions that employ distance medicine-based     approaches may be ideal for promoting healthy activity patterns in breast cancer survivors in     Northern Alberta.   "
182210|NCT00221234|"     This project will assess the incremental and cumulative impact of three behavioural     intervention strategies for the promotion of physical activity in the adult general     population with Type 2 diabetes.   "
182211|NCT00221247|"     Background: Cerebral palsy (CP) is the most frequent cause of childhood disability in the US.     Nevertheless, current standard of care for CP in the U.S. is to a large extent ineffective.     The Chinese, on the other hand, claim to have an exceptionally high response rate with the     administration of an integrated package of care that includes the combination of intense     'conventional' therapies and acupuncture. Despite numerous anecdotal reports, this claim has     not yet been tested in a rigorous scientific way. Objective: To determine the effectiveness     of acupuncture when used as an adjunct to intense 'conventional' physical, occupational, and     hydro- therapies to improve function and quality of life in children with spastic CP.     Hypotheses: (1) Adjunctive acupuncture therapy will improve the gross and fine motor function     and the health related quality of life of children with spastic CP more than intense     'conventional' therapies alone. (2) The level of persistence of gross and fine motor function     and health related quality of life achieved with adjunctive acupuncture administered in     combination with intense 'conventional' therapies will be higher than those achieved with     intense 'conventional' therapies alone. Design: A parallel, two-arm, prospective,     evaluation-blind, pragmatic, non-inferiority, randomized controlled clinical trial (RCT).     Setting: This international collaborative study will be conducted at two different     localities: (1) At the Beijing Children's Hospital (BCH), where participants' recruitment,     intervention therapies, videotape evaluation, and data collection will be done, and (2) At     the University of Arizona, where scoring of the videotape evaluations and data analyses will     be done, and from where logistic support will be provided to assure the scientific integrity     of the study. Population: Approximately 100 children between the ages 1 and 6 years with     spastic CP. Intervention: Concurrent administration of acupuncture with intense     'conventional' therapies at the outset of the study vs. sequential administration of both     components. Outcomes: 'Gross Motor Function', 'Fine Motor Function', 'Range of Motion',     'Level of Motor Involvement', and 'Health-Related Quality of Life' measured at times     0,4,8,12,24,and 36 weeks. Evaluation: Independent blinded evaluation with respect to the type     of the intervention and the stage of the therapeutic schedule done in the U.S. based on     videotapes filmed in China. Data management: Web-based data center and intersite-networking     infrastructure. Data analyses: Intention to treat analysis supplemented by linear mixed     effects models with nested grouping factors. Significance and future directions: If the     hypotheses are confirmed the study would lay the groundwork for future research, and impact     clinical practice and health care policy as related to CP therapy.   "
182212|NCT00221260|"     To investigate if the use of perioperative neuraxial blockade reduces post-operative     mortality and cardiorespiratory events compared to intraoperative general anesthesia AND     postoperative IV narcotic analgesia. This is a feasibility study to determine if recruitment     and execution of the protocol could be done in a timely manner in a much larger trial   "
182213|NCT00221273|"     Compares tension of an ACL graft when using a commercial device vs. the tension of the graft     applied by a physician during surgery.   "
182214|NCT00221286|"     The efficacy of pegylated interferons in the treatment of chronic hepatitis B has shown     superior results to standard of care in patients only infected with hepatitis B. The efficacy     of pegylated interferon for the treatment of chronic hepatitis B in HIV-coinfected patients     is not known at present.      The purpose of this study is to evaluate the efficacy of pegylated interferon in the     treatment of chronic hepatitis B in HIV-infected individuals.      Apart from evaluating the efficacy of pegylated interferon therapy in this setting as such,     i.e. in patients without present or future need of highly active antiretroviral therapy     (HAART) for HIV-infection, there is a second purpose of this study, to investigate whether     combination treatment of HBV-infection may be superior to pegylated interferon therapy alone.      Therefore patients without need of HAART are offered pegylated interferon alfa-2a over 48     weeks. Patients who require HAART are offered emtricitabine / tenofovir DF containing HAART     over 72 weeks PLUS pegylated interferon alfa-2a over 48 weeks vs. emtricitabine / tenofovir     DF containing HAART over 72 weeks WITHOUT pegylated interferon-alfa-2a.   "
182215|NCT00221299|"     The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH),     either alone or with risedronate, will increase the thickness of the bones in the hip and     spine in subjects with osteoporosis from chronic low dose steroid use. During the second     year, the study will also look at whether taking risedronate will preserve the bone thickness     created by one year of rhPTH 1-34 treatment.   "
182216|NCT00221312|"     This is a study to determine if Fosamax (alendronate), a medication approved by the Food and     Drug Administration (FDA) for the prevention and treatment of osteoporosis in postmenopausal     women, is effective in decreasing the rate of bone loss which often begins to increase in the     three to five years preceding the menopause (perimenopausal transition).      During the three to five years prior to the menopause, the rate of bone loss increases. One     way that physicians treat this is with oral contraceptive medication. However, the incidence     of complications from oral contraceptives after the age of 40 increases. Therefore, a     non-hormonal means of preventing bone loss should be useful. Fosamax (alendronate) is in a     class of compounds called bisphosphonates. This study is being done to determine whether     Fosamax can be used to prevent the increased rate of bone loss during the perimenopausal     transition.   "
182245|NCT00228696|"     The Late Effects Study is being conducted in order to answer scientific questions and to     serve as a resource for Wilms tumor patients and their families. Patients must have been     enrolled on the NWTS-5 protocol in order to be eligible for this study.   "
182270|NCT00229372|"     Assessing the efficacy of Posttraumatic Stress Disorder (PE) treatment for chronic     Posttraumatic Stress Disorder (PTSD)   "
182219|NCT00221351|"     We aim to evaluate the impact of a CRP-guided management algorithm for adults with acute     cough illness. More specifically, we will examine both process of care and clinical outcomes:        1. Processes of care (i.e., chest x-rays ordered, antibiotic treatment, length-of-time in          the ED). We hypothesize that CRP-guided management will be associated with a decrease in          the antibiotic prescription for acute cough illness from 50 percent to 30 percent.        2. Clinical outcomes (i.e., duration of illness, any return visit, return visit with a          diagnosis of pneumonia, hospitalization, subsequent antibiotic use, satisfaction with          care). We hypothesize that there will be no difference in the proportion of patients          feeling back to normal within 2 weeks of their ED visit for acute cough illness (about          60 percent, 95% confidence interval=50 to 70 percent).   "
182220|NCT00221364|"     The WHO has initiated a program to eliminate blinding trachoma by the year 2020, in large     part by mass oral azithromycin distributions. It is not clear how frequently or for how long     these treatments are necessary. Here we assess the frequency and duration of treatment.   "
182221|NCT00221377|"     This randomized controlled multi-centre trial in children from birth up to < 5 years of age     aims to demonstrate equivalence as to the major outcome of post-extubation airway injury     (stridor) comparing uncuffed tracheal tubes to current tracheal tubes with modern high volume     - low pressure cuff combined with a cuff pressure release valve.   "
182222|NCT00221390|"     The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in     improving movement among patients with chronic stroke.   "
182223|NCT00221403|"     The primary aim of this proposal is to conduct a preliminary controlled trial of valproate     and risperidone in children ages 3-7 yr. with bipolar disorders. A secondary aim is to     carefully characterize these subjects using clinical rating scales and develop pilot data on     a very young cohort of children with bipolar disorders that can be used to support an     application to NIMH for a prospective, longitudinal study that will provide important     information about the course, medication response, neurobiology and outcome of these     patients.   "
182224|NCT00221416|"     This is an investigator-initiated study whose primary aim is to determine the effectiveness     of aripiprazole (Abilify®) in helping persons with symptoms of mania whose current     medications do not completely control those symptoms. Aripiprazole is a medication that has     been approved by the United States Food and Drug Administration (FDA) for the treatment of     Schizophrenia.      A secondary aim of this research is to explore whether CYP 2D6 polymorphisms are related to     side effects with aripiprazole. The goal of this research is to identify individuals who     metabolize aripiprazole more rapidly or slowly, which will potentially help the clinician     make dosing adjustments and decrease the risk of adverse events.   "
182225|NCT00221429|"     This study will compare the efficacy of lithium, divalproex, and placebo in treating the     acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and     adolescents.   "
182226|NCT00221442|"     The specific aim of this study is to examine the efficacy and safety of zonisamide compared     with placebo in outpatients with binge eating disorder associated with obesity.   "
182227|NCT00221455|"     We seek to determine if patient data entry, data entered based alerts, and data review in a     secure patient portal may provide a sustainable approach to improve diabetic outcomes in a     cost effective manner. We plan to study the extent to which the portal can improve diabetic     outcomes and quality of care. We recognize, however, that some patients will be more     predisposed to adopting technology and some will be more predisposed to improving their     compliance than others. Hence, we will also develop and test interventions that may improve     adoption and compliance. The goals of the proposed study are: 1) to assess whether a web     portal will improve care outcomes in diabetic patients; 2a) to describe the characteristics     of patients whose health behavior improves over the study period; 2b) to describe the     characteristics of patients who adopt the web portal-based disease management technology; 3)     to develop and test targeted interventions to increase the adoption of the web portal and     improve patient health behavior; and 4) to monitor the ongoing costs associated with the web     portal and patient healthcare resource utilization, and to monitor the incremental costs of     the interventions designed to improve utilization of the technology and patient compliance     with their diabetic regimens.   "
182228|NCT00221468|"     The purpose of this research study is to obtain preliminary data regarding the effectiveness,     tolerability, and safety of quetiapine therapy for adolescents who have a mood disorder and     have at least one parent with bipolar disorder (severe mood swings).   "
182229|NCT00221481|"     This study will evaluate how effective mood stabilizers are in the treatment of bipolar     disorder with comorbid alcoholism   "
182230|NCT00221494|"     Antidepressants are commonly prescribed and are effective for treating depression. However,     they generally take 4-6 weeks for a therapeutic response. This study is evaluating whether     simultaneous treatment with thyroid hormone or pindolol can decrease the response time     (getting better faster) in patients who are starting SSRI treatment.   "
182231|NCT00221507|"     The study hypothesis is that case management using patient navigators (promatoras in the     Latino community) will increase infant immunization rates and use of well child care in an     inner city population of low socioeconomic status.   "
182271|NCT00229385|"     Comparing schizophrenic patients with comorbid OCD and schizophrenic patients without OCD in     response to Ziprasidone and in cognitive functioning as compared with OCD patients   "
182272|NCT00229398|"     Assessing psychiatric and physiological co-morbidity in TRD and non-TRD patients   "
182274|NCT00229424|"     The purpose of the study is to verify superiority of the lafutidine group over the placebo     group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the     patients with mild reflux oesophagitis.      Furthermore, the followings are compared:      The improvement effect in heartburn and other subjective symptoms, and dosing frequency of     MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine     20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment     group in patients with mild reflux oesophagitis.   "
182275|NCT00229437|"     The purpose of this study is to determine the efficacy and safety of TAK-128, once daily     (QD), in treating subjects with diabetic peripheral neuropathy.   "
182232|NCT00221520|"     High-risk critically ill patients often require mechanical ventilation either to primarily     support the respiratory function or when the ventilation is insufficient to maintain adequate     gas exchanges as a result of other organ impairment. In order to tolerate this aggressive     mechanical support, enhance patient synchrony with the ventilator, and relieve pain and     anxiety, analgesia and sedation are provided. It is suggested that an inappropriate use of     sedation and analgesia may prolong the duration of mechanical ventilation and increase the     risk of specific adverse outcomes such as ventilator associated pneumonia. Despite the     widespread use of sedation, little information is available concerning the effect of varying     the level of sedation on patients' subsequent mental health. We designed a randomized     controlled trial to investigate the efficacy of sedation with the goal of maintaining the     patient cooperative and interactive compared to the administration of sedation with the goal     of maintaining the patient sedated. The first goal will be achieved by a discontinuous     injection of a sedative, while the second goal will be achieved by a continuous infusion of     the same sedative. In both groups pain relief will be provided in the same fashion with equal     endpoints on a pain scoring scale. Our primary aim is to investigate whether differences in     the occurrence of post-traumatic stress disorders (PTSD), anxiety, and depression are related     to the choice of sedation-analgesia strategies. Secondary endpoints include the length of ICU     stay, as indicated by the time to discharge from the ICU, the time to separation from     mechanical ventilation, the rates of pulmonary and extra-pulmonary complications, and     hospital length of stay. These endpoints will be compared between the two groups.   "
182233|NCT00221533|"     Relation between Renin-Angiotensin Gene Polymorphisms, Plasma Adiponectin and Arterial     Stiffness in Renal Transplant Recipients   "
182234|NCT00221546|"     Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and     health evolution of patients with cystic fibrosis   "
182235|NCT00221559|"     Serum Zn status of patients with cystic fibrosis at diagnosis and one year later, compared to     a healthy control group   "
182236|NCT00228579|"     In this study, we propose to determine the effect of weight loss on amount of body fat, and     on body fat distribution, in severely obese patients. We also want to determine what     measurements (waist, hip or thigh circumference) best show the changes in body fat and fat     distribution in this group. Most importantly, we want to relate the changes in body     measurements to changes in health indicators (blood cholesterol, blood pressure, blood     sugars, liver function). With the findings of this study, clinicians should be able to     predict an improvement in health based on a change in waist, hip or thigh size. Because this     is a pilot study, we will focus on women, who make up the bulk of our clinic population. We     will also focus on racial differences between Caucasians and Blacks.   "
182237|NCT00228592|"     The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs,     in patients who have received liver transplants due to liver failure caused by Hepatitis B     infection. Patients will be evaluated over a 6 month to 1.5 year period to evaluate whether     or not the drugs prevent the Hepatitis B virus from infecting the new liver.   "
182238|NCT00228605|"     The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl     for the potential treatment of breakthrough pain episodes in patients who have chronic     noncancer pain.   "
182239|NCT00228618|"     The purpose of this study is to determine the level of sulfur amino acids in the diet that is     needed to maintaining glutathione antioxidant status. This information could prove very     useful in medicine because it could allow identification of an optimal diet for control of     antioxidant levels. This diet could be used in conjunction with other therapies in order to     prevent or delay oxidative stress and any diseases that may result from this. Total study     participation will include a screening visit and a 14-day study period where dietary intake     of sulfur amino acids will be controlled. We aim to enroll 12 normal subjects at Emory     University Hospital.The primary hypothesis is that steady-state GSH/GSSG and CYS/CYSS redox     in human plasma will become oxidized due to SAA intake at 0% of the RDA and reduced due to     SAA intake at 3X the RDA.   "
182240|NCT00228631|"     In this study, patient blood samples from NMA transplants will be provided by Pittsburgh, and     samples from myeloablative transplants will be provided by Atlanta (comparative controls).     Samples would be obtained pre- and post-BMT from the recipient at a total of 7 timepoints,     and from the donor at one timepoint.   "
182241|NCT00228644|"     Availability of sulfur amino acids (SAA) is critical for glutathione/glutathione disulfide     (GSH/GSSG) and cysteine/cystine (CYS/CYSS) redox in vivo and for many other physiologic     functions including protein synthesis, nitrogen balance, digestion, osmotic regulation,     detoxification, hormonal regulation, biologic methylations, and cell growth regulation. GSH     conjugation and sulfate conjugation represent quantitatively important pathways for chemical     detoxification, which imposes substantial burden upon SAA supply. The primary hypothesis is     that SAA deficient diet and acetaminophen (APAP) administration will perturb Cys metabolism     and GSH redox homeostasis in human plasma and urinary output of SAA metabolites. Because both     of these variations affect SAA homeostasis, it is believed that the combination of these     treatments will produce an interactive effect in which 2-day SAA deficiency will alter APAP     metabolism, APAP will affect SAA homeostasis, and the treatments together will alter the     global metabolic profile, as measured by 1H-NMR spectroscopy.   "
182242|NCT00228657|"     Patients resuscitated with 4% Albumin will have less incidence and reduced severity of     pressure injuries than patients resuscitated with 0.9% Sodium Chloride due to the improved     intravascular oncotic pressure effected from higher albumin levels.   "
182243|NCT00228670|"     The purpose of this study is to: 1) to develop a method to quantify Epstein Barr Virus (EBV)     load in lung tissue of humans and to determine whether EBV viral load is significantly higher     in lung tissue from patients with idiopathic pulmonary fibrosis (IPF) than in control lung     tissue; 2) to determine whether EBV localized to epithelial cells in IPF lungs and to relate     epithelial positivity to tissue viral load; 3) to measure viral load in induced sputum from     IPF subjects over time in order to determine whether periodic active herpes virus replication     occurred in the respiratory tract; and 4) to compare longitudinal measures of viral load in     induced sputum with simultaneously collected saliva in order to assess the clinical utility     of the two approaches.   "
182244|NCT00228683|"     This is a study to collect and bank tissue specimens and blood from patients with     Hepatoblastoma.   "
182247|NCT00228839|"     Acute graft versus host disease (GVHD) remains one of the most significant and potentially     lethal complications of allogeneic bone marrow transplantation. Depending upon the type of     transplant, the incidence of acute GVHD varies between 20 - 50% in related donor transplants,     or as high as 70 - 90% in unrelated donor transplants. Acute GVHD affects the skin, liver and     gastrointestinal (GI) tract and usually occurs within 20 - 40 days of the bone marrow     infusion.      Steroids are the standard initial treatment of acute GVHD, with approximately 50% of the     patients either free of disease or requiring no further therapy. In the remaining patients,     the GVHD either does not respond or it comes back during the tapering of steroids. These     patients have a much worse prognosis with a mortality rate greater than 70%. Studies using     additional agents such as antithymocyte globulin (ATG), monoclonal antibodies, and     anti-lymphocyte globulin showed no improvement over the use of steroids alone. This leads the     investigators to look for new immunosuppressive agents that can reduce the risk and severity     of acute GVHD.      The major purpose of this study is to evaluate the way the body uses and absorbs (the     pharmacokinetic profile) a drug called anti tumor necrosis factor antibody (infliximab) for     the treatment of acute GVHD. Infliximab is currently indicated for the treatment of     immunologic-based diseases (rheumatoid arthritis, moderately to severely active Crohn's     disease, and fistulizing Crohn's disease), assuming patients have had inadequate responses to     conventional therapy. It is not approved for the treatment of GVHD.      This is a Phase I pharmacokinetic study that is coordinated by the Pediatric Blood and Marrow     Transplant Consortium (PBMTC). The study will be conducted in the Blood and Marrow     Transplantation (BMT) program at Children's Healthcare of Atlanta - Egleston, Emory     University Department of Pediatrics. The goal is to enroll 1 - 2 patients on this study;     accrual will be via the BMT program. Eligible patients must be less than 18 years of age.      Patients with newly diagnosed acute GVHD will be able to participate in the study. Patients     will receive a single dose of infliximab in the clinic. Since this is a Phase I study, the     patients will have blood samples drawn to measure the pharmacokinetics of the drug. A total     of 16 blood samples will be drawn over 84 days. The samples will be labeled with a code,     processed, frozen, and then sent in a batch to the PBMTC designated laboratory for testing.     Patients will continue on any drugs they were getting for the prevention of GVHD. Additional     doses of infliximab may be given. This decision will be based on the results of the blood     testing.   "
182248|NCT00228852|"     This is a multi-institution, single arm, non-randomized pilot study coordinated by the     Pediatric Blood and Marrow Transplant Consortium. Eligible patients will have severe combined     immunodeficiency syndrome (SCID) or severe T-cell immunodeficiency disorder. Patients with     these disorders do not have properly functioning immune systems. Without treatment, these     disorders result in early childhood death. The standard treatment used for these diseases is     to give the patient a stem cell transplant from a matched donor. The donor cells can be from     a family member, an unrelated marrow donor or umbilical cord blood. The donor source will     impact on transplant risks and approaches to the preparative regimen.      There have been many different preparative regimens used for patients with SCIDS or severe     T-cell immunodeficiency syndromes. Some patients have gotten no preparative regimen, while     others have gotten only antithymocyte globulin (ATG; immune proteins made in horses that,     when given, will kill lymphocytes). Still other patients have gotten conventional     chemotherapy. In children treated with nothing or ATG alone, there is an increased risk of     graft failure or only partial engraftment. When this happens, patients need life-long therapy     with immunoglobulins to support the immune system. Children treated with chemotherapy     generally have full immune recovery, but also may have major side effects from the     chemotherapy. The side effects include infection, organ failure and infertility.      This protocol, in combination with a parallel study with a separate preparative regimen, will     attempt to answer the question of which patients with primary immunodeficiencies need a     preparative regimen and what intensity is needed. Patients will be enrolled according to     disease type and donor source. The purpose of this study is to see how much chemotherapy is     actually needed for the transplant to work. To be able to do this and still make the     transplant work, the drugs used to temporarily weaken the immune system will be strengthened.     In groups, patients will be treated with lowering doses of the busulfan to find the lowest     dose of this drug that is needed to get full immune recovery. The investigators hope this     regimen will result in complete immune system recovery while limiting the side effects of     chemotherapy. A second purpose of this study is to track the recovery of different parts of     the immune system. The investigators also want to identify whether the recovery is coming     from donor stem cells or from the patient.      The patient will be admitted to the hospital to have the transplant and is expected to stay     for up to 4 to 6 weeks. The preparative regimen will be made up of busulfan, fludarabine and     antithymocyte globulin (ATG). After the preparative regimen, the cells from the donor will be     given. To try and keep the patient's body from rejecting the donor cells and the donor cells     from attacking the patient's body (graft-versus-host disease, or GVHD), cyclosporine will be     given.      The investigators will draw an extra 2 - 4 teaspoons of blood at specified time points to     test for immune recovery and donor cell chimerism (the portion of the blood that belongs to     the donor). Standard bone marrow transplant (BMT) clinical care will be provided with respect     to pretransplant evaluation, peritransplant support, and posttransplant follow-up.   "
182249|NCT00228865|"     To determine if restoring normal metabolic function in patients with either Type I or Type II     Diabetes can improve overall cognitive function. Patients are treated once a week with     pulsatile intravenous insulin therapy mimicking normal insulin secretion and high amounts of     oral glucose consumption.   "
182250|NCT00228878|"     The purpose of this study is to determine if restoring normal metabolic function in patients     with either type I or type II diabetes can improve the impact of the consequences of diabetic     complications on the overall quality of life of diabetic patients. Patients are treated once     a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A 44     item questionnaire is completed prior to the start of the treatment and quarterly thereafter     with detailed analysis performed to measure progress and outcomes.   "
182251|NCT00228891|"     Diabetic neuropathy is a progressive complication causing serious problems in 25-40% of     diabetic patients. Anecdotal reports have indicated improvement with pulsatile IV insulin in     patients otherwise resistant to all conventional therapies. Significant complications produce     painful peripheral dysesthesias, loss of sensation and gastroparesis. This study is designed     to test the effectiveness of pulsatile insulin delivery on diabetic neuropathy.   "
182252|NCT00228904|"     Diabetic neuropathy is a progressive complication causing serious problems in 25-40% of     diabetic patients. Anecdotal reports have indicated improvement with pulsatile IV insulin     therapy in affected patients otherwise resistant to all conventional therapies. Significant     complications produce painful peripheral dysesthesias, loss of sensation and gastroparesis.     This study is designed to test the effectiveness of pulsatile IV insulin therapy on diabetic     neuropathy.   "
182253|NCT00228917|"     This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP)     booster phase, subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or     Tritanrix™-HepB/Hiberix™ (active control) at 15 to 18 or 24 months in a single-blind manner     so that the subjects' parents will not know which vaccine was administered to their child. In     the Mencevax ACWY phase at 24-30 months, a dose of Mencevax™ ACWY will be given in an open     manner to only those subjects who received less than 4 doses of Tritanrix™-HepB/Hib-MenAC. No     blood samples will be taken in this safety study.   "
182254|NCT00228930|"     The purpose of this research is to try to identify which women who take tamoxifen are likely     to suffer from hot flashes or are more likely to have other side effects or benefits from the     drug. The researchers will do so by determining whether there are mutations that normally     occur in human DNA that might influence the way individuals respond to medications.   "
182255|NCT00228943|"     The purpose of this proposal is to improve our understanding of the role of tryptophan and     serotonin in hot flashes. The main hypothesis is that alterations in tryptophan and serotonin     levels are involved in the induction of hot flashes in women with breast cancer and genetic     variations in the serotonin receptors and transporters also play a role.   "
182256|NCT00228956|"     You are invited to participate in a research study looking at metabolism (breakdown) and     effects of aromatase inhibitors. The purpose of this research is to try to identify which     women who take an aromatase inhibitor are more likely to have certain benefits or side     effects from the drug. We will do so by determining whether there are differences that     normally occur in genes that you have inherited from your parents that might influence the     way individuals respond to medications. If you agree to participate in this study, you will     be asked to sign this informed consent form.   "
182257|NCT00228969|"     The primary objective of this study is to evaluate the efficacy, safety, and tolerability of     4 daily doses of RWJ-333369 as adjunctive treatment of refractory partial epilepsy in     subjects who are between 18 and 70 years of age, inclusive   "
182258|NCT00228982|"     The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril     versus a comparator in the treatment of patients with complicated skin and skin structure     infections.   "
182259|NCT00228995|"     The purpose of this study is to assess changes in physical function in elderly patients (>=     65 years of age) with chronic anemia (Hb <= 11.0 g/dL) due to anemia of unknown cause and     receiving weekly subcutaneous doses of Epoetin alfa (PROCRITÂ®) versus placebo.   "
182260|NCT00229008|"     The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the     water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator     in the treatment of patients with nosocomial pneumonia.   "
182261|NCT00229021|"     The purpose of this study is to compare the microbiological cure rate of doripenem versus a     comparator antibiotic in the treatment of patients with complicated urinary tract infection     or pyelonephritis. The study will also characterize the safety and tolerability of treatment     with doripenem in patients with complicated urinary tract infection or pyelonephritis.   "
182277|NCT00229463|"     The purpose of this study is to identify genes involved in depression. Specifically, the     investigators will analyze some genes that may be related to whether or not a person responds     to antidepressant medication. This project is part of basic scientific research to increase     understanding of the role of genetic influences in psychological and mental processes     involved in the response to treatment for depression.   "
182278|NCT00229476|"     The primary purpose of the research study is to use recordings of brain electrical activity     (through electroencephalogram, or EEG) and symptom measurements to determine whether patients     are likely to show a response to medication or placebo treatment during a treatment trial for     depression.   "
182279|NCT00229502|"     The purpose of this study is to examine and compare changes in the specific thinking skills     of patients with RRMS who are receiving treatment with one of three immunomodulatory     medications (Avonex, Copaxone, or Rebif).   "
182280|NCT00229515|"     The purpose of this study is to determine which from the four combinations     tirofiban+sirolimus eluting stent (SES), tirofiban+bare metal stent (BMS), abciximab+SES,     abciximab+BMS is the possible gold standard treatment for ST-segment elevation myocardial     infarction in terms of efficacy and cost-efficacy.   "
182281|NCT00229528|"     COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in     the body that make platelets stick together. These platelets may be important in the     initiation of a heart attack (myocardial infarction). A chemical in the body called serotonin     maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in     platelet serotonin and therefore may have value in preventing heart attacks. Therefore, the     current study is designed to determine whether paroxetine will decrease COAT-platelet     production in normal volunteers and patients with cardiovascular disease.   "
182282|NCT00229541|"     The randomised controlled trial explores the efficacy of a counselling interview on an     multidisciplinary multimodal intervention to ameliorate the somatic, mental and social     medical progress of rheumatoid arthritis in gainfully employed insurants of compulsory health     insurances and statutory pension insurances . Additionally, the feasibility to recruit a     study population via databases of compulsory health insurances is examined.   "
182283|NCT00229554|"     Despite strong evidence for the effectiveness and cost-effectiveness of a variety of     colorectal cancer (CRC) screening methods for reducing CRC mortality, current CRC screening     rates fall far below the levels needed to significantly impact CRC mortality. Unfortunately,     however, the existing literature on patient CRC screening behavior does not yet provide a     sufficient evidence base for making sound recommendations regarding how to most effectively     improve upon these rates in the VA. This study will inform future CRC screening promotion     efforts and make important scientific contributions to existing literature by: (a)     delineating the relative contribution of patient cognitive, environmental and background     factors to CRC screening behavior using a multi-level, theory driven analysis approach on a     nationally representative sample, and (b) identifying the determinants of variation in CRC     screening behavior across vulnerable population subgroups.   "
182284|NCT00229567|"     Bowel function after bowel surgery is delayed (postoperative ileus)by both opiates and the     surgery itself. We hypothesized that decreasing opiate use by other analgesics will speed the     return of bowel function after surgery. Lidocaine and Ketamine are drugs that appear to be     synergistic and do not slow peristalsis. This study is a Randomised Controlled Trial of     Lidocaine Infusion Plus Ketamine Injection versus Placebo to to determine whether they will     decrease opiate use and then whether decreased opiate use will speed the return of bowel     function.   "
182285|NCT00229580|"     The purpose of this study was to explore whether a brief (3 session) intervention would     impact health behavior of veterans with hepatitis C. The main focus of the intervention was     on reduction of heavy drinking with patients who have liver disease. Other study goals were     to increase the likelihood that patients would seek out substance use treatment and/or     hepatitis C health care services. The study also tested the use of a liver function test     called CDT/GGT in detecting heavy drinking. The main hypothesis was that a 3 session     intervention with personalized feedback about health behavior would result in a reduction in     alcohol use and increased use of substance use treatment and hepatology health care.   "
182286|NCT00229593|"     The purpose of this study is to determine the usefulness of two transdermal gels to be used     in the future development for a male contraceptive.   "
182333|NCT00230217|"     This is an open-label, multi-center study with 2 arms. The primary objective is to assess the     response to treatment with rasburicase in 2 populations of adult and pediatric patients with     lymphoma/leukemia/solid tumor malignancies, those previously treated with a uricolytic agent,     and those not previously treated with a uricolytic agent at their first relapse or refractory     disease.   "
182375|NCT00230763|"     To determine the predictive factors of a positive response to latanoprost 0.005% / timolol     0.5% fixed combination (defined as a 10% IOP reduction from baseline), after 12 weeks of     treatment (age, sex, ethnic origin, patient's medical history, family history of OAG or OHT,     concomitant systemic treatment with beta-blockers, etiology, IOP at baseline, corneal     thickness, compliance, and adverse events).   "
182287|NCT00229619|"     This study will test whether the immune-suppressing drug rituximab can increase blood counts     and reduce the need for transfusions in patients with moderate aplastic anemia, pure red cell     aplasia, or Diamond Blackfan anemia. These are rare and serious blood disorders in which the     immune system turns against bone marrow cells, causing the bone marrow to stop producing red     blood cells in patients with pure red cell aplasia and Diamond Blackfan anemia, and red blood     cells, white blood cells and platelets in patients with aplastic anemia. Rituximab is a     laboratory-made monoclonal antibody that recognizes and destroys white blood cells called     lymphocytes that are responsible for destroying bone marrow cells in these diseases. The drug     is currently approved by the Food and Drug Administration for treating patients with B-cell     non-Hodgkin lymphoma, a disease of white blood cells.   "
182288|NCT00229632|"     This study will determine whether a drug called idebenone is safe and effective in reducing     the level of oxidants that are believed to damage the nervous system and hearts in patients     with Friedreich's ataxia. Friedreich's ataxia is caused by an abnormality in the gene that     makes a protein called frataxin, which is necessary for the proper functioning of     energy-producing parts of cells called mitrochondria. In Friedreich's ataxia, the     mitochondria become overloaded with iron, and high levels of harmful compounds called     oxidants are formed. These oxidants are believed to damage the cells of the nervous system     and hearts of people with Friedreich's ataxia. Idebenone is a man-made drug similar to a     naturally occurring compound known as Coenzyme Q10. This study will test whether idebenone     can alleviate some of the symptoms of Friedreich's ataxia and slow or halt the progression of     the disease.      Patients with genetically confirmed Friedreich's ataxia who are between 9 and 18 years of     age, weigh between 65 and 175 pounds and can walk 25 feet with or without an assistive device     may be eligible for this study. Candidates are screened with blood tests and a review of     their medical records.      Participants undergo the following tests and procedures:        -  Medical interview and physical examination. Tests include blood and urine tests, an          electrocardiogram, or EKG (recording of the electrical activity of the heart),          echocardiogram (ultrasound test showing the pumping action of the heart, thickness of          the heart walls, and any valve leakage), and a detailed neurological examination,          including maneuvers such as copying a drawing and putting pegs in a board. Patients'          parents are asked questions about how they feel their child's disease affects the          child's quality of life.        -  Magnetic resonance imaging (MRI) to examine the heart muscle and blood flow to the          heart. MRI uses a magnetic field and radio waves to produce images of body tissues and          organs. The patient lies on a table that is moved into the doughnut-shaped MRI scanner,          wearing earplugs to muffle loud knocking and thumping sounds that occur during the          scanning process. A catheter (plastic tube) is placed in a vein in the child's arm so          that a chemical called gadolinium can be injected during the MRI study. Gadolinium          brightens areas of the heart, improving the ability to see the heart and blood flow.        -  Physical medicine and rehabilitation evaluations to test the child's physical          functioning. These tests include gait evaluation, measurements of the ability to exert          and maintain a constant force, assessment of visual-motor control and fine motor          control, aerobic exercise endurance testing, and measurement of the ability of the          child's heart and lungs to increase their effectiveness with exercise.        -  Idebenone/placebo treatment. Patients are given a 6-month supply of either idebenone          pills or placebo (pills that look like the study drug but have no active ingredient) to          take three times a day. Patients are seen by their primary care physician after 1 and 3          months on the study medication for a brief physical examination. In addition, they have          blood and urine tests once a month while on medication to check for any abnormalities.        -  6-month examination. After 6 months on the study drug, patients return to NIH to repeat          all the tests listed above to determine the effects of idebenone treatment.   "
182335|NCT00230243|"     This retrospective study is designed to provide a consistent method of screening and     collecting data on patients who will serve as controls for a comparison of the efficacy of     the available antifungal therapies used as salvage treatments for patients with refractory     IFI or for patients with refractory IFI or for patients with IFI who are intolerant to     standard antifungal therapies.   "
182289|NCT00229645|"     Major depression occurs with generalized anxiety disorder and panic disorder in up to 60% of     psychiatric and primary care patients.(1) An estimated 85% of adults with depression     experience significant symptoms of anxiety and 58% have a diagnosable anxiety disorder during     their lifetime.(2) Numerous studies have shown that symptoms of anxiety are frequent in     patients with major depressive disorder, and the presence of anxiety symptoms is associated     with a more severe and chronic course.(3,4) This comorbidity has been associated with a     greater severity of depression, poorer psychosocial functioning, poorer treatment response     and higher risk for suicide.      The data suggests that novel antipsychotics have antidepressant and anxiolytic effects. This     study will explore the impact of this effect in patients with major depression and comorbid     anxiety symptoms.      This study offers the possibility of systematically reviewing the role of quetiapine in     depression with anxiety. If the combination of an SSRI or SNRI and quetiapine proves to     effective it could offer a viable alternative to widespread benzodiazepine use.   "
182290|NCT00229658|"     This is an open label, observational study designed to collect data that characterize the use     of SYMLIN following the introduction of the medication into the marketplace. Health care     providers and subjects selected for study participation are intended to be representative of     those providers prescribing, and subjects receiving, SYMLIN therapy.   "
182291|NCT00229671|"     The purpose of this study is to determine the rates of medication errors in pediatric     outpatients in 6 office practices. Further, we wish to determine the effectiveness of a     computerized physician order entry (CPOE) system in reducing errors.   "
182292|NCT00229684|"     This is a prospective 24-week, randomized, parallel-group, multi-center, active-controlled     (pioglitazone 45 mg) open-label study designed to assess the effects of tesaglitazar 2 mg per     day on components of renal excretion of creatinine in type 2 diabetics. The study comprises a     2-week enrollment period, followed by a 24-week double blind treatment period and an 8-week     follow-up period   "
182293|NCT00229697|"     This study is being carried out to see if ZD1839 is effective in treating metastatic breast     cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.   "
182294|NCT00229710|"     This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to     monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with     type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment     and follow-up, is 143 weeks.   "
182295|NCT00229723|"     The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg     when given either concomitantly or as maintenance to a standard therapy of radiotherapy     (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free)     rate at 2 years.   "
182296|NCT00229736|"     Safety Study in subjects with Parkinson's Disease   "
182297|NCT00229749|"     Chronic active hepatitis C viral infections are difficult to treat: current drug therapies     can result in severe side effects that some patients will not tolerate. AVI-4065 Injection is     a new drug designed to prevent the virus from reproducing in the body. We tested this drug in     healthy adult volunteers to optimize the dosing regimen, and are now proceeding in adult     patients with chronic active hepatitis C infections. Patients who have the disease and who     have had treatment but without success, will be recruited for the study.      The treatment of HCV patients initially consisted of subcutaneous injections given twice a     day for 14-days. Treatment arms of 28 days, twice or three-times per day have been added.   "
182298|NCT00229762|"     The goal of the study was to determine effectiveness of a telephone reminder to increase     pneumococcal vaccination in a managed care population.   "
182299|NCT00229775|"     The purpose of this study is to determine whether artemether + lumefantrine is as effective     as chloroquine + sulfadoxine pyrimethamine in the treatment of uncomplicated Plasmodium     falciparum malaria   "
182300|NCT00229788|"     For children who develop graft failure following cardiac transplantation, retransplantation     is often considered. While some centers have reported equivalent results for     retransplantation as compared to primary transplantation, this strategy remains     controversial. We seek to examine outcomes following re-transplantation in children and     identify risk factors for mortality. In addition, adult African-Americans have been reported     to have lower survival following heart and other solid-organ transplantation. The     relationship of recipient race to survival following pediatric heart transplantation has not     previously been reported.   "
182329|NCT00230165|"     Blood contains red blood cells, white blood cells, and platelets, as well as a fluid portion     termed plasma. We primarily study blood platelets, but sometimes we also analyze the blood of     patients with red blood cell disorders (such as sickle cell disease), white blood cell     disorders, and disorders of the blood clotting factors found in plasma.      Blood platelets are small cell fragments that help people stop bleeding after blood vessels     are damaged. Some individuals have abnormalities in their blood platelets that result in them     not functioning properly. One such disorder is Glanzmann thrombasthenia. Most such patients     have a bleeding disorder characterized by nosebleeds, gum bleeding, easy bruising (black and     blue marks), heavy menstrual periods in women, and excessive bleeding after surgery or     trauma. Our laboratory performs advanced tests of platelet function and platelet     biochemistry. If we find evidence that a genetic disorder may be responsible, we analyze the     genetic material (DNA and RNA) from the volunteer, and when possible, close family members to     identify the precise defect.   "
189272|NCT00316550|"     The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1)     antagonist, in subjects with Irritable Bowel Syndrome.   "
182334|NCT00230230|"     This randomized, multicenter, parallel-group, double-blind, double-dummy, placebo- and     active-controlled study will evaluate the efficacy and safety of SCH 486757 in subjects with     persistent cough resulting from a recent viral upper respiratory infection (URI). The primary     objective is to assess the efficacy of SCH 486757 administered at a dose of 100 mg twice     daily for 5 days in the reduction of cough severity score compared with placebo. The key     secondary objective is to evaluate the reduction in the number of coughs with SCH 486757     compared with placebo. Because codeine is a widely used as a cough medication, it is included     as a treatment arm in the study.   "
182336|NCT00230256|"     The purpose of the research study is to evaluate effectiveness and the quality of life,     specifically the risk of dry mouth, after radiation treatment for head and neck cancers.   "
182301|NCT00229801|"     Clinical measurement of renal function is generally performed using either laboratory tests     or nuclear medicine techniques, however, both of these techniques suffer from some     limitations. Notably the lab tests only assess global, rather than individual kidney,     function and the nuclear medicine tests are demanding to perform well. Children with brain     tumors are often treated with chemotherapeutic in order to try and kill the cancer. Amongst     the known side effect of some of the drugs used in the chemotherapy is the fact that they may     damage the kidneys. For this reason the function of the kidneys is assessed using a     laboratory test at 3 or 6 months intervals during the treatment. In addition, to the problem     mentioned above the tests also require a separate visit to the hospital. Children with brain     tumors who are undergoing chemotherapy also routinely have contrast-enhanced MRI of the brain     performed at intervals of three months in order to evaluate the response of the tumor to the     chemotherapy. Recently, MRI techniques have been developed which can evaluate single kidney     renal function. The aim of this study is to establish if a single MRI exam can be used to     assess both the effect of the chemotherapy on both the tumor and the renal function. The     results of the MRI measurement of the single kidney renal function would be combined to     provide a measure of global renal function and this would be compared with that obtained from     the laboratory test. The MRI exam will require only require an extra 10 minutes of scanning     time and will not affect the rest of the MRI exam in any way.      This study is being performed to validate a new technique for measuring kidney function.     Patients are being asked to volunteer for this study because they require serial contrast     enhanced MR scans to monitor their response to chemotherapy. Because some chemo-therapeutic     agents can be toxic to the kidney the patient's kidney function will also be evaluated using     conventional methods, and the results of these tests can be compared to those obtained using     MRI. We plan to study 50 children in this study. The additional procedure for measuring renal     function will add 10 minutes to the duration of the MRI exam and will have no effect on the     routine brain study. If validated the proposed MRI technique would allow renal function to be     evaluated at the time of a routine, contrast enhanced MRI exam and would avoid additional     testing using radioactive tracers or urine collection over 24 hours.      If successful, MRI could be used to measure single kidney renal function in all any patient     undergoing a routine MRI exam by simply extending the scanning time by a maximum of 10     minutes. This would save such patients additional visits to the hospital and would have the     advantage of measuring single kidney, rather than global, renal function.   "
182302|NCT00229814|"     Tectal plate gliomas are relatively rare tumors of childhood with a reported incidence of     10%. Their typical clinical presentation is symptoms and signs of hydrocephalus and are often     incidentally diagnosed in the imaging work-up of children with hydrocephalus. Tectal tumors     in children comprise a subcategory of brainstem tumors with unique clinical, imaging, and     spectroscopic features. There is debate whether they truly represent brainstem tumors or     whether they are a site of benign cellular overgrowth. The majority of these tumors are     pathologically benign and show no or minimal growth. Not all tectal plate tumors, however,     have this typically benign course. Some can manifest a more aggressive behavior. There have     been reports in the past attempting to analyze the histology and behavior of these tumors.     None of the prior series looking at these tumors have included Magnetic Resonance     Spectroscopy (MRS) analysis.      It is interesting that according to where tumors occur in the brainstem usually indicates     what their histology and behavior is. Although not absolute, we know that tumors can have a     very poor prognosis versus an extremely good prognosis depending on their location in the     brainstem. Yet there are always the cases that do not act in the typical fashion and this is     where MRS can prove helpful.      This study is being done to look at a region of the brain, called the tectal plate, in     children. This part of the brain can be involved by tumors. Because of the location of the     tectal plate, it is usually very difficult and risky to get a biopsy (tissue sample) from     this area. Magnetic Resonance Spectroscopy (MRS) is a non-invasive imaging technique that can     look at the chemical make up of the brain. MRS may allow us to better understand the nature     and behavior of these tumors. However, in order to understand disease in this area, we need     to look at the normal chemical make up of the brain in children without tectal plate tumors.     Healthy patients are being asked to participate as a normal volunteer. We anticipate having a     total of 10 to 12 normal volunteers in the MRS study.   "
182303|NCT00229827|"     The purpose of this study is to determine the optimal timing for repair of left-to-right     shunt lesions such as ventricular septal defects and atrioventricular canals.   "
182304|NCT00229840|"     This study is being done to look at the relationship between brain structure and brain     function in patients with epilepsy or focal brain lesions (abnormal areas) that require     surgery. This study will look at an imaging technique called magnetic resonance imaging (MRI)     for looking at the brain. Specifically, the study will look at functional MRI, which is an     imaging technique that can map brain function by taking pictures of the brain as it performs     different tasks such as reading, thinking, or moving a body part and diffusion tensor imaging     (DTI), which will look at brain structure. These types of imaging may help us learn more     about different areas of the brain and how those areas of the brain are used in children with     epilepsy. We plan to study 30 children with epilepsy.   "
182305|NCT00229853|"     The purpose of this study is to review the use of diverticulopexy, and collect data regarding     the ease of the procedure and the overall outcome.   "
182306|NCT00229866|"     The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a     NG tube, G-tube placement or Nissen fundoplication.   "
182307|NCT00229879|"     The purpose of this study is to do a literature review and combine all of the cases of the     intrapericardial teratoma tumor and see if some conclusions can be made about this rare tumor     in children.   "
182308|NCT00229892|"     The purpose is to evaluate the investigators' length of incisions based on patient weight,     operative times, hospital lengths of stay, pain medicine requirements, complications and     costs. These data will lead to a new minimally invasive standard of care without a reduction     in outcomes.   "
182309|NCT00229905|"     The purpose is to see if any conclusions can be drawn about the uncommon heart defect:     anomalous drainage of the inferior vena cava to the left atrium.   "
182310|NCT00229918|"     Prospective randomized clinical trial comparing Laser Alone v. Laser and posterior sub-tenon     injection of triamcinolone acetonide for primary and refractory clinically significant     macular edema.   "
182311|NCT00229931|"     The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA)     injection at the time of cataract surgery will improve visual acuity and decrease     post-operative swelling in diabetic patients requiring cataract extraction as compared to the     conventional treatment of laser following cataract surgery.      The subjects will be followed for 11 visits over 3 year. Visits will occur at screening,1,     3,6,9,12,18,24,30 and 36 months post surgery.   "
182330|NCT00230178|"     This is a randomized, multi-center, open-label, parallel group study with three arms:        -  Rasburicase alone        -  Rasburicase followed by Allopurinol        -  Allopurinol alone      The primary objective is to compare the adequacy of control of plasma uric acid concentration     and the safety profile among the three arms.   "
182331|NCT00230191|"     The primary objective of the study is to assess the effect of RK-0202 versus placebo on the     incidence and severity of oral mucositis in subjects receiving radiation therapy for head and     neck cancer. Concurrent chemotherapy is not allowed in the study.   "
182332|NCT00230204|"     The purpose of this investigation is to assess the prevalence of infectious disease     seropositivity (toxoplasmosis, rubella, cytomegalovirus [CMV]), herpes simplex virus type 1     (HSV-1) and herpes simplex virus type 2 (HSV-2), syphilis, Epstein-Barr virus and H. pylori     in a group of patients presenting with specific autoimmune diseases (rheumatoid arthritis     [RA], undifferentiated connective tissue disorder [UCTD], Sjogren, antiphospholipid syndrome     - APS, vasculitides, systemic lupus erythematosus [SLE], polymyositis, Hashimoto, multiple     sclerosis, primary biliary cirrhosis [PBC], etc.), using the BioPlex 2200 and complementary     EIA kits as compared to matched controls (by age, sex and ethnicity).   "
182312|NCT00229944|"     Cholera remains an important cause of diarrhoeal illness and death in Asia, Africa and Latin     America. Antimicrobial therapy is an important adjunct to fluid therapy in the management of     patients with cholera, and should be given to all patients with clinically moderate-to-severe     disease since they can reduce the diarrhoea duration and stool volume by half. Current     therapy for cholera is limited by increasing prevalence of multiply-resistant strains of     Vibrio cholerae O1 or O139. Tetracycline and doxycycline had been the drugs of choice for     treating cholera, but multiply-resistant strains are now present in all areas where cholera     is endemic or epidemic. There is thus a need to identify alternative drugs that are effect in     treating this disease.      Azithromycin, a newer macrolide agent, is active in-vitro against V. cholerae, attains high     concentrations in the gut lumen, has a long half-life, and is better tolerated than     erythromycin, and older macrolide. In this study we will compare efficacy of a single, 1.0 g     oral doses of azithromycin and ciprofloxacin in male patients, aged 18-60 years, with cholera     due to V. cholerae O1 or O139. Patients with typical “Rice watery” stools of cholera, signs     of severe dehydration and characteristic cholera vibrios in a dark-field stool microscopy.     Patients who have coexisting illness which may confound assessment of the efficacy or safety     will not be eligible. Only those patients who have V. cholerae O1 or O139 isolated from their     pre-therapy stool and/or rectal swab culture and remains in the hospital for the entire     duration of the study will be eligible for efficacy evaluation. A written informed consent     will be obtained from each patients for their enrollment in the study.      Patients will be hospitalized for full 5 days, and asked to return for a follow up evaluation     7 days after discharge. After initial rehydration, patients will be observed for 4 hours, and     only those with ³ 20 ml/kg of watery stools during this period will be enrolled for study.     Treatment will be random, and blinded to study staff and patients. Clinical success of     therapy will be defined as resolution of watery stool within 48 hours of administration of     the study drug, and bacteriologic success will be defined as the inability to isolate V.     cholerae O1 or O139 from fecal/rectal swab cultures of patients after 48 hours of therapy,     i.e. on day 3 and on all subsequent days of the study. Patients in whom therapy clinically     fails will be treated for 3 days with an effective alternate drug without opening the study     code. Ninety one evaluable patients will be required in each group to show with a power of     80% and a type I error of 5% that the two treatment regimens are equivalent (i.e. the 95%     confidence interval for the difference in efficacy between the two groups is not greater than     10%).      If single-dose azithromycin therapy is found effective it will provide an important option     for the treatment V. cholerae infections, especially those caused by multiply-resistant     strains.   "
182313|NCT00229957|"     The purpose of the study is to determine whether occupational therapy and physiotherapy     delivered in a primary care setting to adults with chronic illness is effective in improving     health.   "
182314|NCT00229970|"     This study evaluates the efficacy and safety of MK0476 intravenous administration in adult     patients with acute asthma.   "
182315|NCT00229983|"     The goal of this study is to assess the efficacy of a new intervention based on motivational     enhancement therapy among adolescents with a history of substance use.   "
182316|NCT00229996|"     The Specific Aim of this project is to compare the efficacy and cost-effectiveness of     continuous oral contraceptives versus leuprolide/norethindrone in the treatment of     endometriosis-associated chronic pelvic pain. This comparison will be based on a randomized,     double-blind, trial of women with chronic pelvic pain who have been diagnosed with     endometriosis at the time of surgery within the last 3 years. We hypothesize that, over a     12-month period of postoperative treatment, the efficacy of oral contraceptives is no worse     than leuprolide/norethindrone, and that treatment with oral contraceptives is more     cost-effective.   "
182317|NCT00230009|"     Preliminary controlled trial of a brief intervention designed to reduce child maltreatment     risk among low-income pregnant mothers. Foci will include major risk factors for     maltreatment, including substance abuse, social isolation, depression, violence exposure, and     maladaptive child-rearing attitudes/beliefs.   "
182318|NCT00230022|"     Pilot trial of computer-based motivational intervention. Hypothesis: The brief     computer-delivered intervention would result in higher motivation to change at follow-up.   "
182319|NCT00230035|"     Systemic lupus erythematosus, also known as lupus or SLE, is a chronic, multisystem,     autoimmune disease in which the body's internal system of defense attacks its own normal     tissues. This abnormal autoimmune response can result in damage to many parts of the body,     especially the skin, joints, lungs, heart, brain, intestines, and kidneys. Both genetic and     environmental risk factors are involved in the development of lupus, but these are poorly     understood.      SLE has an overall 10-year survival between 80 and 90%. However, we estimate that severe     lupus not responding to the usual available treatments has a 50% mortality rate in 10 years.     Kidney problems occur in 30% to 50% of lupus patients and may progress to kidney failure.     Kidney disease due to lupus occurs more frequently in African-Americans and Hispanics. Lupus     can affect many parts of the body and cause damage, but the severe form can result in death     from kidney disease; cardiovascular disease, specifically atherosclerosis; central nervous     system disease; and infections.      Currently, no single standard therapy for treatment of severe SLE exists. Usually physicians     prescribe an aggressive regimen of one or a combination of immunosuppressive/immunomodulatory     treatments. This approach to therapy for all forms of severe SLE derives largely from studies     of lupus nephritis. Current treatment, although effective in many people, are not effective     in all patients and are associated with drug-induced morbidity. The design of the control arm     for this study reflects the current status of treatment of SLE in the academic setting.     Investigators may choose from a list of commonly used and currently available     immunosuppressive/immunomodulatory treatments to optimize the treatment of their patients,     based on their past treatment history and response to those treatments. Study treatments may     consist of corticosteroids, cyclophosphamide (CTX), azathioprine, methotrexate, cyclosporine,     mycophenolate mofetil (MMF), plasmapheresis, intravenous immunoglobulin (IVIG), rituximab,     and leflunomide. Treatment may be changed as frequently and as necessary within the first     year of the study to control the manifestations of SLE in each patient. New therapies that     become available during the course of this trial may be added to the list of approved     medications for this study.      In response to the absence of a uniformly effective treatment for severe lupus, autologous     hematopoietic stem cell transplantation (HSCT) has been proposed as a potential therapy.     Hematopoietic stem cells are immature blood cells that can develop into all of the different     blood and immune cells the body uses. Researchers believe that resetting the immune system     may stop or slow down the progression of the disease. The main purpose of this study is to     compare two ways of treating SLE: 1) high-dose immunosuppressive therapy (HDIT) followed by     HSCT and 2) currently available immunosuppressive/immunomodulatory therapies.   "
182320|NCT00230048|"     Interactive Motivational Media for Perinatal Drug Abuse   "
182321|NCT00230061|"     In this study we compare the efficacy of two different HBV-vaccination schedules in     HIV-infected persons concerning immune response and compliance. Short schedule: t=0,1,3 weeks     and standard schedule: t=0,1,6 months.   "
182322|NCT00230074|"     This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346     compared to placebo in patients with mild or mild to moderate stages of ALS.   "
182323|NCT00230087|"     The purpose of this study is to find out whether lowering the amount of iron in the body will     result in less resistance to insulin and improved liver function in patients with type 2     diabetes mellitus and non-alcoholic fatty liver disease. This may result in better diabetes     control and/or a decrease in the amount of liver fat.   "
182324|NCT00230100|"     The purpose of this study was to develop a gender-specific 12-session, manual-based relapse     prevention group for women with substance use disorders (SUDs).   "
182325|NCT00230113|"     The purpose of this study is to determine whether dietary supplementation with omega-3     polyunsaturated fatty acids will decrease the amount of fat in liver.   "
182326|NCT00230126|"     This study determines tumor response rate, time to tumor progression and survival rate at 1     year produced by OSI-774 in previously treated African American patients with nonsmall cell     lung cancer.   "
182327|NCT00230139|"     The value of fusion of functional and anatomical data has been described using several fusion     techniques for various nuclear medicine procedures and morphologic imaging modalities     (SPECT-CT, SPECT-MRI, Coincidence-CT). We hypothesize that NM -CT data has advantages over     the data obtained using separately performed NM study and conventional anatomic imaging as     CT. We hypothesize that more accurate localization of the radio-isotope activity on NM images     will improve diagnostic accuracy and will have an impact on patient management:      Improved accuracy of NM study will improve tumor localization, the evaluation of the extent     of disease and the post therapy follow up.      It will direct other diagnostic procedures to lesions otherwise undetected, or exclude the     need for more invasive procedures. It can also guide invasive procedures and     radiation-therapy planning, thus improving therapy results and avoiding unnecessary     treatment-related side effects.   "
182328|NCT00230152|"     The synergistic value of the fusion of physiologic and anatomical data has been described     using several co-registration techniques for various nuclear medicine procedures and     morphologic imaging modalities (single photon emission computed tomography-computed     tomography [SPECT-CT], SPECT-magnetic resonance imaging [MRI], camera-based positron emission     tomography [PET]-CT and PET-CT). The researchers hypothesize that fusion of nuclear medicine     (NM) and CT data acquired sequentially in a single imaging session on one device is     clinically superior to side-by-side evaluation of separately performed imaging tests. They     hypothesize that more accurate localization of increased radiotracer activity on NM     procedures will improve the diagnostic accuracy for detection of infection and will     subsequently have a significant impact on patient management.      The purpose of the present study is to assess the clinical value of this new technology of     fused imaging in patients undergoing diagnostic nuclear medicine evaluation for suspicion of     an infection process.   "
182337|NCT00230269|"     In patients with cancer of the head and neck and rectum, knowing the exact location of the     tumor is important for designing the radiation field to ensure delivery of high dose of     radiation to the tumor while sparing surrounding normal tissues. A new medical imaging method     which is a combination of positron emission tomography (PET) and computed tomography (CT)     scan, has shown promise in helping the radiation oncologist in defining the exact location     and extent of the tumor in certain cancers such as lung cancers. Therefore the purpose of     this study is to determine if these imaging methods can be used in combination with the     standard radiation treatment planning procedure to improve the accuracy to targeting your     tumor with radiation. In addition the PET-CT scan, similar to the PET scan alone with better     resolution, can be used to determine whether the tumor has spread to any part of the body     outside of the head and neck sites.   "
182338|NCT00230282|"     The primary objective of this study was to evaluate the safety and efficacy of the     combination of fludarabine and cyclophosphamide in previously untreated CLL patients.     Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day     cycles.   "
182339|NCT00230295|"     To determine the ability of magnetic resonance lymphangiography using conventional gadolinium     injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis     in patients with newly diagnosed H&N cancers   "
182340|NCT00230308|"     Through this study, we hope to learn more about the mechanisms, which may contribute to     development and progression of head and neck cancer. The long-term goal of this study will be     to develop new strategies and drugs for the diagnosis and treatment of head and neck cancer.   "
182341|NCT00230321|"     The primary objectives of the trial are to assess erythroid response to darbepoetin alfa, as     determined by changes in hemoglobin and/or red blood cell (RBC) transfusion-dependence and to     describe the safety profile of darbepoetin alfa in patients with MDS. The secondary objective     is to assess bone marrow progenitor BFU-E growth before and after treatment with darbepoetin     alfa.   "
182342|NCT00230334|"     The purpose of the trial is to determine the safety and efficacy of Gleevec in idiopathic     hypereosinophilic syndrome (HES) and to characterize the molecular basis for the therapeutic     benefit of Gleevec in HES.   "
182343|NCT00230347|"     This study is intended to establish the practicality of treating cancer in the liver with     precisely administered single fractions of high-energy radiation using a radiosurgical     (cross-firing) technique. A second purpose is to establish a safe dose for such therapy.     Finally, the efficacy of radiosurgical ablation of liver tumors, in terms of radiographic     response, will be measured.   "
182344|NCT00230360|"     Purpose To compare different kinds of diagnostic investigations in order to identify the most     sensitive and least invasive when diagnosing constipation.   "
182345|NCT00230373|"     Localized scleroderma or morphea is a fibrotic disease, imiquimod induces cytokines which     inhibit fibrotic activity . We propose that topical imiquimod 5% cream is efficacious and     safe in treating plaque-type morphea. Twenty adults will be enrolled for a pilot study. A     screening and baseline clinic visit will be required for each patient enrolled in the study.     Each visit will involve completing a medical history, skin examination, digital pictures,     histologic examination if the patient consents and an ultrasonographic score. One morphea     plaque will be treated with topical imiquimod 5% cream, and another morphea lesion with     vehicle cream. Patients will be asked about side effects (local and systemic). Patients will     be followed up in the clinic at 3, 6 and 9 months of therapy, and 3 months following end of     treatment period (month 12).   "
182346|NCT00230386|"     This is a pilot study of 50 patients to establish whether there is a potential role for MRI     perfusion in the detection of locally recurrent or persistent prostate carcinoma after     previous treatment with radiotherapy. All subjects will be patients who have had localised     prostate cancer treated with radiotherapy and have already agreed to undergo a biopsy of the     prostate to look at local control within the prostate as part of their management. The     objective of the study is to establish whether there is a relationship between recurrent or     persistent disease within the prostate and increased perfusion on MRI at these sites.   "
182347|NCT00230399|"     This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan,     for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually,     are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The     combination of these two drugs is experimental (not approved by the FDA as standard     treatment), but is a widely used treatment option and preliminary studies have shown that     treatment with the combination of capecitabine and irinotecan has a positive effect on     metastatic colorectal cancer. Likewise, previous research in animals has shown that     celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type     and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.   "
182348|NCT00230412|"     The purpose of the investigators' study is to determine whether the production of heat shock     proteins has an effect on the development and the outcome of acute renal failure in children.   "
182376|NCT00230776|"     To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of     pain associated with fibromyalgia and improvement of function of patients with fibromyalgia   "
182349|NCT00230425|"     The purpose of this study is to measure daily mood changes and to find out whether these mood     changes are related to the ability to maintain attention on a task. Problems with mood are     more common among women however, the association between symptoms of alcohol abuse and mood     syndromes is inconsistent.      First we hypothesize that women with lifetime diagnoses of alcohol abuse will not demonstrate     higher symptoms of anxiety, depression, neuroticism and mood variability than control groups.     Second, that the severity of these symptoms will not correlate with performance on measures     of sustained attention.   "
182396|NCT00231049|"     This is a randomized, multi-center, sequential, dose-escalating study of three dose cohorts     of AG-707. Individuals who meet all of the inclusion and exclusion criteria for eligibility     will be randomized to receive either AG-707 (at the 80 µg dose), AG-707 with QS-21 (at the 80     µg dose), placebo, or QS-21. Each patient will be monitored for safety as specified in the     protocol.   "
182397|NCT00231062|"     A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal     sinuses.   "
182350|NCT00230438|"     Delivery of conformal radiation therapy following radical prostatectomy is limited by the     inability to define the clinical target volume (CTV). This stems from a poor understanding of     patterns of local recurrence and limitations of standard imaging techniques.Magnetic     Resonance Imaging (MRI) is a promising modality for imaging the prostatic bed following     radical prostatectomy. MRI provides more detailed postoperative anatomy to guide CTV     delineation, the ability to document local recurrence patterns, and a method to assess     intrafraction prostatic bed motion and deformity to define appropriate planning target volume     margins. The aim of this pilot study is to develop a technique for external beam radiation     therapy (EBRT) following radical prostatectomy based on MRI-delineation of the CTV. Twenty     patients will be enrolled in this pilot, development phase.   "
182351|NCT00230451|"     Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer     of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation     therapy may add benefit. The purpose of this study is to determine if a treatment program of     combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery     will delay or eliminate recurrence of the cancer.   "
182352|NCT00230464|"     Incretin hormones (GIP and GLP-1) stimulate insulin release in a glucose dependant manner,     hence are necessary for maintenance of normal glucose tolerance. Both GIP and GLP-1 are     degraded and inactivated by DPP-4.      LAF 237 is an inhibitor of DPP-4 that has been shown to increase meal-stimulated levels of     intact GLP-1 in animals and patients with T2DM..      The purpose of the current study is to explore the acute effects of LAF237 on the rate of     appearance and disappearance of glucose in type 2 diabetics. Secondary objectives include the     effect on FPG, insulin secretion rates, glucagon and FFA levels, and rate of glucose entry     from the GI tract.   "
182353|NCT00230477|"     This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine     combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil     and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic     hepatitis B.      The primary hypothesis is that subjects treated with combination therapy will see their viral     DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary     hypothesis is that subjects treated with combination therapy will have a higher HBeAg     conversion rate compared to historical controls of subjects treated with lamivudine or     adefovir dipivoxil monotherapy.   "
182354|NCT00230490|"     Compare the long-term safety of pradefovir to adefovir dipivoxyl   "
182355|NCT00230503|"     -  Compare the safety of four oral doses of pradefovir after 48 weeks of treatment        -  Select the dose of pradefovir for Phase 3 studies   "
182356|NCT00230516|"     This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers     better intragastric acid suppression than iv lansoprazole (Prevacid ®   "
182357|NCT00230529|"     The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade)     in patients with plaque-type psoriasis.   "
182358|NCT00230542|"     The purpose of this study is to determine the effects (good and bad) the combination of     carboplatin and pemetrexed have on patients with recurrent ovarian, peritoneal, or fallopian     tube cancer.   "
182359|NCT00230555|"     The purpose of the MOM Program is to promote child development by helping families become     more competent in accessing and using available resources. The program focuses are childhood     immunizations, Early Intervention services, lead screening, Early Head Start and Head Start     enrollment. The hypothsis is that children receiving the intervention will participate in     more of the public services and primary healthcare activities which have been shown to be     effective in improving their development.   "
182360|NCT00230568|"     12-week, open-label study to evaluate the effectiveness and safety of donepezil hydrochloride     in Hispanic patients with mild to moderate Alzheimer's Disease (AD) in the U.S.   "
182361|NCT00230581|"     In this study, female patients with IBS-d will be treated for 8 weeks to assess the safety     and effectiveness of DDP225 on GI transit and in reducing IBS symptoms.   "
182362|NCT00230594|"     The purpose of this study is to determine whether desmopressin administered as a melt tablet     is effective in reducing the number of wet nights in children and adolescents who suffer from     bedwetting.   "
182363|NCT00230607|"     The study will last for up to 2 years (24 months). Full participation for both mother and     infant is 24 months, full participation of mother and development of infant is 24 months,     while full participation of mother and no infant participation is 6 months   "
182364|NCT00230620|"     Hereditary haemorrhagic telangiectasia is a disease inherited as an autosomal dominant     disease. Analysing DNA from affected and unaffected family members allows us to identify the     location of disease genes by linkage analysis. Sequencing genes in the interval identified by     linkage analysis allows us to identify which precise gene is mutated. Further functional     studies can then determine why the mutations in that gene cause the disease.   "
182365|NCT00230633|"     Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an     disease that leads to the development of dilated and fragile blood vessels. We propose to     take blood samples from patients with HHT, and culture white blood cells that express the     proteins mutated in HHT, namely endoglin and ALK-1. We will study the properties of these     cells which will involve their growth in media prompting different types of differentiation,     or infection of cell lines with Epstein Barr virus to provide cell lines which can be     repeatedly studied. It is anticipated that DNA, mRNA and proteins will be extracted from     these cells for study of white cell responses and association with expression levels of     endoglin and ALK-1 We hypothesize that these cells which express half-normal endoglin or     ALK-1 will show altered protein synthetic differences when compared to normal white blood     cells. We anticipate that that these findings may help to explain aspects of the HHT disease     phenotype.   "
182398|NCT00231075|"     Safety and Efficacy of Paraplatin in combination with Taxol in patients of 70 years or older     with epithelial ovary cancer F.I.G.O. stages III and IV.   "
182399|NCT00231101|"     A single-blind switching study in which forty subjects currently being treated with     risperidone will be randomly assigned to either stay on risperidone or switched to     quetiapine. Various behavioral and biological measures will be used to compare smoking     behavior over time in these two groups.   "
182366|NCT00230646|"     Colorectal cancer is the third most common cancer in the U.S. and if detected early, has a     favorable prognosis. Colorectal cancer survivors report increased fatigue, low vigor,     impaired physical functioning and disturbances in body esteem. However, the group is     relatively understudied and the potential benefits of increased physical activity to their     recovery have not been examined. This study focuses on enhancing recovery by offering a     home-based physical activity program to patients who have completed treatment for colorectal     cancer. This study will test the efficacy of the physical activity intervention using a     randomized controlled design among 134 patients who have completed treatment for colorectal     cancer in the past 2 years. Outcomes will include physical activity behavior, fitness, vigor,     fatigue, physical functioning, and body esteem among participants at baseline, 3     (posttreatment), 6 and 12 months. We will also track intervention costs and conduct     exploratory analyses of moderators and mediators of change to help guide the future     development of physical activity interventions to enhance recovery from colorectal cancer.   "
182367|NCT00230659|"     The inherited disease hereditary haemorrhagic telangiectasia (HHT) causes bleeding from     dilated fragile vessels, particularly in the nose and gut. However, many HHT patients develop     deep venous thromboses and/or pulmonary embolism, necessitating treatments with     anticoagulants that further impair control of their haemorrhagic state. Our initial     observations using general coagulation tests suggest that the blood of HHT patients is     intrinsically hypercoagulable.      We hypothesize that the genetically-determined abnormality in the blood vessels of HHT     patients leads to alteration in the concentrations or activity of one or several of the     proteins which affect blood clotting leading to a hypercoagulable state.      We propose to study levels and activity of blood coagulation factors in people with     hereditary haemorrhagic telangiectasia and in normal volunteers. This should define the     significance and basis for our initial observations, and will have significant implications     for the clinical management of HHT patients.   "
182368|NCT00230672|"     Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an     disease that leads to the development of dilated and fragile blood vessels, including     arteriovenous malformations in the lungs (PAVMs). We hypothesize that the     genetically-determined abnormality in the blood vessels of HHT patients leads to alteration     in the concentrations or activity of several proteins in the blood stream. We propose to take     blood samples from patients at defined times in order to study changes in blood protein     levels and activity   "
182369|NCT00230685|"     The Hammersmith Hospital provides a clinical service for patients with Hereditary     haemorrhagic telangiectasia and pulmonary arteriovenous malformations that is unique in the     United Kingdom. Measurements obtained as part of standard clinical practice that has evolved     since 1985 allow us to assess whether particular groups of individuals that we see are more     prone to recognised complications such as strokes, brain abscesses, pregnancy related     complications or pulmonary hypertension. We hypothesise that certain clinical characteristics     will predict the susceptibility of individuals to particular complications.   "
182370|NCT00230698|"     The purposes of this study are (1) to compare the effectiveness of two doses of topiramate     and (2) to assess the safety of topiramate alone in the treatment of pediatric and adult     patients with recently diagnosed epilepsy characterized by partial-onset seizures.   "
182371|NCT00230711|"     This study aims at testing the efficacy of a physical activity (PA)intervention in an     outpatient oncology setting. We plan to compare Brief Advice for PA (MD advice plus contact     control) vs. Extended Advice (MD advice plus telephone-based PA counseling by research staff)     over 3 months among 300 women who have completed treatment for breast cancer in the past 2     years.      Specific Aims: The primary aim is to examine the effects of oncologists' advice on PA plus     telephone counseling (Extended Advice) vs. oncologists' advice (Brief Advice) alone on     minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed     treatment for breast cancer.      Secondary aims include examining a) the effects of the two interventions on participants'     moderate-intensity PA at 6 and 12 months, b) the effects of the interventions on     participants' physical functioning, fatigue, vigor and quality of life (QOL) at 3, 6 and 12     months, and c) the acceptability of the interventions to the oncologists and the usefulness     of the interventions to patients.   "
182372|NCT00230724|"     Maintaining exercise participation among patients who have completed cardiac rehabilitation     is integral to secondary prevention of coronary events and cardiac re-hospitalization. To     promote exercise maintenance after completion of a 12 week Phase II rehabilitation program,     we propose to offer a theoretically-based intervention that we have used successfully to     promote exercise among older, primary-care patients. This program (Maintenance Counseling)     includes brief advice from the Cardiac Rehabilitation case manager at Phase II program     discharge followed by telephone-counseling based on the Transtheoretical Model of Behavior     Change and Social Cognitive Theory. Health educators will provide the telephone-based     intervention over 6 months. Using a randomized controlled design, 180 patients will be     assigned to Maintenance Counseling or Brief Advice plus Contact Control. Outcome assessments     will include an exercise tolerance test (baseline/post-rehabilitation and 6 months),     self-reported exercise participation, motivational readiness for exercise, and objective     activity monitoring at baseline, 6, 12 and 18 months.   "
182373|NCT00230737|"     This study will determine whether melatonin tablets will increase the sleep of older adults     with insomnia.   "
182374|NCT00230750|"     The purpose of this research study is to compare how the body reacts to different strengths     of a new H5N1 flu vaccine. Researchers will also look at how antibodies are made after     subjects receive the H5N1 flu vaccine. Participants will include at least 240 healthy males     and females, aged 65 and older. The vaccine is given as an injection or shot in the arm.     Subjects will receive 3 doses of vaccine at Day 0, Month 1 and Month 6. There are 2 different     doses of the new H5N1 vaccine that will be given in this study. There is also a chance that a     subject may receive a placebo (dummy) injection of saltwater instead of the flu vaccine.     Study procedures will include physical exams and blood sample collections. Additionally,     participants will complete a memory aid card to document daily temperatures and any symptoms     experienced for a week after receiving vaccine. The length of participation in this study     will be approximately 14 months.   "
182377|NCT00230789|"     To evaluate the effect of tolterodine ER in conjunction with behavioral intervention on     subject satisfaction in OAB subjects who were dissatisfied with their most recent     antimuscarinic OAB medication therapy.   "
182378|NCT00230802|"     Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose     adjustment recommendations to be made at the first confirmation of pregnancy in women with a     history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism     who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon     confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid     hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every     two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints     will be the proportion of women in each group who remain euthyroid throughout the first     trimester and throughout pregnancy.   "
182379|NCT00230815|"     This is a prospective, open-label, multicenter, trial evaluating subject satisfaction and     efficacy with follitropin alfa injection applied by Pen device compared with the subject's     previous experience with injectable gonadotropins in oligoanovulatory infertile women     undergoing ovulation induction   "
182380|NCT00230828|"     Patient-reported health economic outcomes for patients enrolled in S1543003 and S1543004     protocols   "
182381|NCT00230841|"     Croup affects 5% of children under 6 years of age, resulting in visits to hospital Emergency     Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered     is humidification which can liquify airway secretions and decrease airway swelling. This     study will compare the effectivenesss of 40% and 100% humidity through a specially designed     machine called a nebulizer, with the usual humidity set-up (blown into the patient's face     from a hose).   "
182382|NCT00230854|"     The purpose of this study is to assess the safety and efficacy of repeated intravenous     infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with     chronic hepatitis C genotype 1.   "
182383|NCT00230867|"     Currently approved drugs for the treatment of herpes labialis (cold sores) exhibit low levels     of efficacy due to the limited ability of the drugs to penetrate the skin to the site where     the herpes virus is replicating. Iontophoresis uses electric current to enhance the delivery     of drugs through the skin. This trial is testing a new iontophoretic device for the delivery     of acyclovir cream to treat cold sores.   "
182384|NCT00230880|"     The New Generation Health Center/University of California, San Francisco (UCSF) will     implement an intervention to impact contraceptive behavior and reduce unintended pregnancy     and sexually transmitted infections (STIs) among adolescent females who receive services at     the New Generation Health Center (NGHC)/UCSF in San Francisco. Study subjects will be     randomized into either standard reproductive health services or standard services plus     follow-up motivational counseling telephone calls. Outcomes will be evaluated by ETR     (Education, Training, Research)Associates, who will conduct follow-up surveys with all study     participants at baseline, 6 months, 12 months and 18 months.   "
182385|NCT00230893|"     The primary objective is to examine the percentage of patients with PTSD who were prescribed     an antipsychotic over the past seven years in the VA Network 7 (AL, GA, SC) and compare the     percentage on an annual basis. We will also determine the type and dose of antipsychotics     received. We hypothesize that there has been a significant increase in antipsychotic use,     especially atypical antipsychotics, prescribed for patients with PTSD over the last 7 years   "
182386|NCT00230906|"     Comparison of the uremic toxin removal by haemodialysis either with a low flux or a new high     flux cellulose triacetate membrane   "
182387|NCT00230919|"     Overweight and obesity is increasing in most countries, including Norway, and the optimal     diet for reducing weight is under discussion. The present study in overweight and moderate     obese individuals compares a low glycemic load diet with a standard low-fat diet (as     recommended from the National Nutrition Council) in an open, randomized trial over 12 months,     with changes in weight loss and changes in cardiovascular risk markers as endpoints.   "
182388|NCT00230932|"     Our purpose is to evaluate the reliability and validity of the '5th vital sign' in everyday     practice settings and to compare the relationship of pain to other symptoms and pain     treatment in patients with cancer, CHF, and patients with complex general medical illness and     poor self-reported health.   "
182389|NCT00230945|"     The purpose of this study is to determine if osteoarthritis patients and their spouses     experience greater health benefits from a couples-oriented psychosocial intervention than a     patient-oriented psychosocial intervention, and to determine if each intervention is more     beneficial than patient usual medical care.   "
182390|NCT00230958|"     This purpose of this study is to determine the safety and effectiveness of viramidine to     ribavirin in chronic hepatitis C patients who have never before recieved treatment.   "
182391|NCT00230971|"     This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus     metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy     through the test-of-cure assessment. Safety evaluations will occur through the treatment and     post-treatment periods and continue through resolution or stability of the adverse event(s).   "
182392|NCT00230984|"     Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure     and nutritional depletion.      This is a randomized controlled, open clinical trial with two groups.        -  first group, 100 patients : control group, patients followed with no add-on intervention        -  Second group, 100 patients : rehabilitation group with education, oral supplements,          exercise and androgenic steroids.   "
182393|NCT00230997|"     TRIAL SUMMARY:      This is an open-label, 24-week, investigator initiated study to evaluate the safety and     efficacy of galantamine (16 8 to 24 mg/day; flexible dosing) in the treatment of Dementia     with Lewy bodies. The primary efficacy variables will be the NPI -12, the COGDRAS tests of     attention and visuospatial orientation, and the ADCS-CGIC. The secondary efficacy variables     will be the MMSE, ADCS-ADL-Inventory, ADAS-Cog, PSQI, and the use of concomitant rescue     antipsychotic medication. PET scanning will be obtained on 10 patients at one site. An     interim analysis will also be performed. Safety outcome measures will be adverse event     reports, vital signs, physical examinations, ECG, laboratory parameters and the UPDRS (motor     subscale).   "
182394|NCT00231010|"     This multinational study will investigate the inheritance of genetic retinal degeneration in     families of different nationalities and ethnic backgrounds in order to identify the genes     that, when altered, cause retinal degeneration. The retina is a light-sensitive membrane     lining the back part of the eye. It relays vision signals to the brain, which the brain     interprets into sight. When the retina degenerates, vision is altered and possibly lost. The     findings of this study should help improve diagnosis and methods of treatment for these     disorders. Participating institutions include: the National Institutes for Health in     Bethesda, Maryland; the University of Miami in Florida; the Casey Eye Institute in Portland,     Oregon; the Byrd Health Sciences Center in Morgantown, West Virginia; the University of Texas     Southwestern Medical School in Dallas, Texas; the University of Tennessee Health Sciences     Center in Memphis; the Prasad Eye Institute in Hyderabad, India; National Center of     Excellence in Molecular Biology in Lahore, Pakistan; and the Jules Gonin Hospital in     Lausanne, Switzerland.      Patients with retinitis pigmentosa and closely related diseases such as Usher syndrome,     snowflake vitreoretinal dystrophy and Bietti crystalline dystrophy may be eligible for this     study. Participants undergo the following tests and procedures:        -  Medical and surgical history, including family history of vision problems.        -  Examination to clarify the type of retinal degeneration.        -  Eye examination, including tests of color vision, field of vision and ability to see in          the dark        -  Electroretinogram to test the function of visual cells. For this test, the patient sits          in a dark room for 30 minutes with his or her eyes patched. Then, a small electrode          (silver disk) is taped to the forehead and the eye patches are removed. The surface the          eyes is numbed with eye drops, and contact lenses are placed on the eyes. The patient          looks inside a large dark globe that emits a series of light flashes. Then a light is          turned on inside the globe and more lights flash. The contact lenses sense small          electrical signals generated by the retina when the light flashes.        -  Hearing tests for patients with a personal or family history of deafness. Tests include          an audiogram, ear examination and test of middle ear function. For middle ear function          testing, the patient feels a little air pressure change for a moment and hears some          tones. Another test requires the patient to sit quietly with electrodes on the head,          forehead and earlobes.        -  Balance testing, including walking in a straight line, standing with eyes closed in the          dark and other tests of coordination, and caloric testing. For the caloric testing, any          ear wax in the ear canal is removed before the test begins. Then, electrodes are placed          on the skin near the eyes and on the forehead. A small amount of cool (sometimes cold)          or warm water is instilled into each ear canal, first one and then the other.        -  Blood sample collection for genetic testing.   "
182395|NCT00231023|"     This study will evaluate which of the three following treatment options is better for     diabetic macular edema: laser alone, steroid injection alone, or steroid injection followed     by laser. Macular edema is a swelling in the small central part of the retina - the part of     the retina that is used for sharp, straight-ahead vision. Laser treatment is the only     treatment that has been proven to be beneficial for diabetic macular edema. It reduces the     swelling and lessens the chance of further vision loss, but it does not improve vision.     Triamcinolone is a steroid drug that decreases inflammation and scarring. Injections of the     drug have decreased macular edema in some patients and improved vision. Swelling may return,     requiring repeat injections, and it is not known if the vision improvement is permanent. This     3-year study will examine and compare the benefits and side effects of both treatments, alone     and in combination.      Patients 18 years of age and older with diabetic macular edema may be eligible for this     study. Participants undergo the following tests and procedures.      At the beginning of the study:        -  Blood tests to measure HbA1C (measure of diabetes control).        -  Measurement of blood pressure.        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to          examine pupils, lens, retina and eye movements. The pupils are dilated with drops for          this examination.        -  Optical coherence tomography (OCT) to measure retinal thickness. This test shines a          light into the eye and produces cross-sectional pictures of the retina. These          measurements are repeated during the study to determine if retinal thickening is getting          better or worse, or staying the same.      Photographs of the retina and lens. A special camera with bright flashes is used to take     these photographs.      Treatments      Some patients will have one eye treated and some patients will have both eyes treated. The     treatment for a given individual is determined by chance:        -  Triamcinolone acetonide injection alone. The steroid is injected in the tissue around          the eye. Two injection procedures are used in the study, differing in their location and          dose. Numbing drops are placed over the area to be injected and the steroid is injected.        -  Laser treatment alone. The surface of the eye is numbed with drops and a contact lens is          placed on the eye during the laser beam application. Before the treatment, patients may          have fluorescein angiography, in which pictures of the retina are taken using a yellow          dye. The dye is injected into a vein and travels to the blood vessels in the eye. The          camera flashes a blue light in the eye and takes pictures that show the amount of dye          leakage into the retina. Treatments may be repeated at several visits.        -  Triamcinolone acetonide plus laser treatment. Patients who receive both the steroid          injection and laser have the steroid injection first and the laser treatment 1 month          later.      Follow-up      Patients return to the clinic for follow-up visits at 1, 2, 4, 8, 12, 24 and 36 months, or     more often if needed, after the initial treatment for an eye exam, measurement of visual     acuity, and OTC. Photographs of the retina are taken at the 4- and 8-month visits and at the     1-, 2- and 3-year visits. Fluorescein angiography may be done at 4 months. Blood pressure is     measured at the 1-, 2- and 3-year visits, and an HbA1c blood test is done at 4 and 8 months     and at the yearly visits. Participants may be asked to complete a questionnaire once a year     about their vision and medical condition. Treatment options are discussed at the 4- and     8-month visits.   "
182655|NCT00233519|"     The aim of this study is to investigate the safety and feasibility of daily subcutaneous     injections of recombinant IGF1 complexed with IGF binding protein 3 (SomatoKine-INSMED) as a     treatment for muscle wasting and weakness in myotonic dystrophy type 1.   "
182400|NCT00231114|"     The objective of this randomized, double blind, sham-controlled study is to demonstrate the     safety and effectiveness of the Alair System in a population of subjects with severe asthma     who are still symptomatic despite being managed on conventional therapy of high doses of     inhaled corticosteroids and long-acting β2-agonists.      The primary efficacy endpoint will be the difference between Study groups in the change in     Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from     the 6-, 9-, and 12-month follow-up visits.      All other outcome measures assessed at 12 months post-treatment.      This will be a multicenter, randomized, double-blind, sham-controlled study comparing the     effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids     (ICS) and long-acting β2-agonists (LABA).      A Bayesian adaptive approach to sample size selection is used with a randomization scheme of     2:1 (two Alair Group Subjects for every one Control Group Subject).   "
182401|NCT00231127|"     The goals of the trial are:        -  To determine the prevalence of osteoporosis in subgroups of COPD patients.        -  To look for risk factors of osteoporosis in COPD patients.        -  To create sub-groups for prospective research concerning the effects of bisphosphonates          on osteoporosis variables in COPD patients.   "
182402|NCT00231140|"     Neuroinflammation has recently emerged as a significant contributor to motor neuron damage.     ALS tissue is characterized by inflammatory changes that are observed in both sporadic and     familial ALS and in the ALS superoxide dismutase 1 (SOD1) transgenic mouse model. They     include an accumulation of large numbers of activated microglia and astrocytes.      Proinflammatory cytokines, such as tumor necrosis factor (TNF-), are robustly upregulated in     ALS. The receptor for tumor necrosis factor- (TNF-R1) is elevated at late presymptomatic as     well as symptomatic phases of disease. TNF acts as a principal driver for neuroinflammation     in ALS, while several co-stimulating cytokines and chemokines act to potentiate the TNF     effects [4-6].      We propose an investigational therapy of ALS with oral administration of thalidomide. The     rationale for this study is based on the anti-inflammatory properties of thalidomide through     the modulation of inflammatory cytokines such as TNF. The primary aim of the trial is to     determine whether treatment with thalidomide is safe and well tolerated in conjunction with     riluzole and whether patients with ALS can tolerate daily doses of up to 400 mg. The trial is     designed as feasibility study in planning for a larger phase IIb/III trial of efficacy.   "
182403|NCT00231153|"     The purpose of this study is to determine whether treatment with topical omiganan is more     effective than treatment with topical povidone-iodine in preventing local catheter site     infections and catheter colonization in patients who have central venous catheters.   "
182404|NCT00231166|"     The purpose of this study is to determine the highest tolerated dose, safety and activity of     HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.   "
182405|NCT00231179|"     The purpose of the MOM Program Continuation is to promote child development by helping     families become more competent in accessing and using available health, developmental and     educational resources. The program focuses are childhood immunizations, Early Intervention     services, lead screening, Early Head Start and Head Start enrollment. The Intervention     consists of frequent phone calls and home visits to encourage mothers to have their babies     immunized on schedule and to participate in needed developmental and educational services.     The program seeks to fill the gap between children's need for services and mothers' ability     to assure their children's participation in those services.   "
182406|NCT00231192|"     This study will test the hypothesis that oral repaglinide is equivalent to insulin in the     treatment of new-onset CFRD in adolescents. In addition, successful treatment of CFRD with     repaglinide will improve nutritional status, ameliorate declines in pulmonary function, and     will not have a negative impact upon quality of life.   "
182407|NCT00231205|"     The purpose of the study is to test accuracy of positive preejection velocity to predict left     ventricular remodeling and long-term prognosis after revascularization in 200 patients with     chronically dysfunctional myocardium. Patients will be followed for 3 years.      Our hypothesis is that tissue-Doppler-derived analysis of positive preejection velocity     allows to select optimal responders to revascularization; it means individuals with the     greatest benefit in terms of LV remodeling and long-term prognosis.   "
182408|NCT00231218|"     We hypothesize the herbal preparation will enhance the preschoolers' immune response and when     taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections     and gastroenteritis in the active versus the control group.   "
182409|NCT00231231|"     The primary objective of this study is to assess the outcomes of stenting with distal     protection in the treatment of obstructive carotid artery disease during     peri-approval/initial commercialization in relation to the outcomes of the Sapphire Clinical     Trial. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems and the Cordis     ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).   "
182410|NCT00231244|"     The objective of this study is to allow treatment with the sirolimus-eluting Bx VELOCITYTM     stent in patients with a serious disease or condition for which there is no generally     acceptable alternate treatment available.   "
182411|NCT00231257|"     The main objective of this study is to demonstrate the superiority or non-inferiority of the     sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with     in-stent restenotic native coronary artery lesions.   "
182412|NCT00231270|"     The primary objective of this study is to compare the safety and effectiveness of the Cordis     Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal     protective device to CEA in the treatment of carotid artery disease in patients at increased     risk for surgery.   "
182413|NCT00231283|"     The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT     Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System     (SDS) in patients with de novo native coronary artery lesions.   "
182414|NCT00231296|"     A multi-center, randomized, controlled study of cryoablation vs medical management for the     treatment of PAF   "
182446|NCT00231725|"     Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home     situations. Patients must use insulin lispro injection [rDNA origin] Low Mix twice daily     during the trial.   "
182415|NCT00231309|"     The major purpose of this study is to evaluate the curative potential of white cell growth     hormone (G-CSF)-stimulated bone marrow cells in allogeneic bone marrow transplants. Patients     with cancers or blood diseases, who have poor potential for a cure with standard treatment,     will be able to participate in the study. Donors will receive the white cell growth hormone     (G-CSF) as a shot (injection) in their arm once a day for three days before they donate their     bone marrow cells. Total body irradiation and/or chemotherapy will be given first to prepare     the patient's body for the infusion of new bone marrow cells from the donor. Two medicines     (cyclosporine and methotrexate) will be used to prevent the new bone marrow cells (graft)     from attacking the patient's body (host) (graft-versus-host disease; GVHD). Certain safety     checkpoints were built into the study if unwanted/unexpected events were to occur. If the     outcomes appear better than could be expected, this will provide a bridge to extend this     current approach for other innovative therapies.   "
182416|NCT00231322|"     To assess the influence of seasonal variations in Schistosoma haematobium transmission on     treatment outcome (morbidity and re-infection)   "
182417|NCT00231335|"     A primary hypothesis to be explored here is that, given its pharmacodynamic profile and     hypothesized mechanisms associated with schizophrenia, escitalopram will, in comparison to     placebo, be effective when added to risperidone or olanzapine treated group in reducing the     severity of resistant symptoms, particularly existing subsyndromal anxiety and depression.   "
182418|NCT00231348|"     The purpose of this study is to determine the effectiveness of nefazadone in patients with     social anxiety disorder (SAD).   "
182419|NCT00231374|"     This is a study looking at pressure changes in the fluid that surrounds the spine when a     person is positioned in 2-3 different ways.   "
182420|NCT00231387|"     This is a phase IIIb, randomised, double blind, placebo controlled, study in patients with     type 2 diabetes mellitus and coexisting vascular disease or hypertension. The total duration     of the study will be approximately 60 weeks. The aim of this study is to examine the     potential beneficial effects of rosiglitazone on carotid atheroma in patients with type 2     diabetes mellitus and coexisting vascular disease or hypertension. It is hypothesised that     treatment with rosiglitazone will lead to an decrease in plaque size. In addition, it is     hoped that rosiglitazone will have a positive effect on plaque composition and stability.   "
182421|NCT00231400|"     The Pompe Registry is an ongoing, international multi-center, strictly observational program     that tracks the routine clinical outcomes for patients with Pompe disease, irrespective of     treatment status. No experimental intervention is involved; patients in the Registry undergo     clinical assessments and receive care as determined by the patient's treating physician.      The objectives of the Registry are:        -  To enhance the understanding of the variability, progression, and natural history of the          key manifestations of Pompe disease;        -  To assist the Pompe medical community with the development of recommendations for          monitoring patients and reports on patient outcomes to help optimize patient care;        -  To characterize and describe the Pompe disease population as a whole; and        -  To evaluate the long-term effectiveness and safety of available treatment options          including ERT(Enzyme Replacement Therapy) with Myozyme®.   "
182422|NCT00231413|"     Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in     men and women. Several types of HPV infection are transmitted by sexual activity and, in     women, can infect the cervix (part of the uterus or womb). This infection, if it persists,     can lead over a long period of time to cancer of the cervix in women. In collaboration with     MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic     types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating     novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a     novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately     376 study subjects will receive the novel HPV vaccine or the control vaccine administered     intramuscularly according to a 0-1-6 month schedule   "
182423|NCT00231426|"     The ASSURE Study will evaluate shock conversion performance when programming the first shock     of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of     either 1) a single induction of ventricular fibrillation (VF) and subsequent demonstration     conversion success at 14 J or 2) an upper limit of vulnerability (ULV) test at 14 J.   "
182424|NCT00231439|"     Inflammatory cytokines in the cerebrospinal fluid may contribute to the new muscle weakness,     fatigue and pain experienced by patients with post-polio syndrome. Intravenousimmunoglobulin     (IvIg) reduces this inflammation. The purpose of this study is to investigate the clinical     effect of IvIg in post-polio syndrome.   "
182425|NCT00231452|"     The overall objective is to evaluate the effect of exposure to Plasmodium (P.) falciparum     erythrocytic stage antigens during different periods of infancy on the development of     naturally acquired immunity (NAI).      Hypothesis: Exposure to P. falciparum prior to 5 months of age does not result in the     development of NAI, while exposure to P. falciparum after 5 months of age leads to the     development of NAI. The risks of clinical malaria and anaemia during the second year of life     will be compared between cohorts, as well as their correlations with the type and quality of     immune responses (antibodies to several P. falciparum antigens, cytokines), oxidative stress     markers and host genetic factors. These results should shed light on the determinants of the     development of anti-P. falciparum responses early in life and the potential constraints to     early life immunisation.   "
182426|NCT00231465|"     This is a Phase II, open-label trial of Taxotere® + ZD1839 in elderly patients with Stage     III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease. Patients     with prior adjuvant chemotherapy were allowed to enroll on this trial.   "
182427|NCT00231478|"     This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of     Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be     randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril     intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for     tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is <3 months,     and the planned sample size was 170 patients.   "
182447|NCT00231738|"     The purpose of this study was to test the hypothesis that the long-term use of highly (＞98%)     purified EPA, in addition to HMG-CoA reductase inhibitor (statin), would be more effective     than statin alone in preventing cardiovascular events in Japanese patients with     hypercholesterolemia.   "
182428|NCT00231491|"     Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This     condition is often resistant to anticholinergic drugs used as a first line treatment for this     purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use     of those treatments. This study is designed to evaluate the efficacy and safety of botulinum     toxin A injected into the detrusor muscle to control symptoms and improve quality of life for     patients resistant or intolerant to anticholinergic drugs.   "
182429|NCT00231504|"     The deficit in the total number of antral follicles is associated with a reduction of the     ovarian fertility potential in young women.      The principal objective of this study is to evaluate the relationship between FSH receptor     polymorphism and antral follicle count.      The investigators have designed a study of FSH receptor polymorphisms P1 and P2 as an     association with a low antral follicle count in the ovary.   "
182430|NCT00231517|"     Randomised Double blind placebo controlled cross over design study of the efficacy of     morphine for inflammatory pain in children with Epidermolysis Bullosa   "
182431|NCT00231530|"     The purpose of this study is to determine the efficacy and safety of topiramate compared with     placebo in obese, Type 2 diabetic patients on a controlled diet.   "
182432|NCT00231543|"     The aim of this trial was to characterise the intra and post operative metabolic, endocrine     and inflammatory response to laparoscopic fundoplication in children. We are testing the     hypothesis that laparoscopic fundoplication is associated with a lack of hypermetabolism and     catabolism and blunting of the endocrine/inflammatory stress response   "
182433|NCT00231556|"     The purpose of this study is to compare the safety and effectiveness of two doses of     topiramate as monotherapy in the treatment of pediatric and adult patients with newly     diagnosed or recurrent epilepsy.   "
182434|NCT00231569|"     The aim of this study is to assess the safety of varying doses of ISIS 301012 in subjects on     Stable statin therapy.   "
182435|NCT00231582|"     High-dose chemotherapy (HD-CT) is able to circumvent platinum-resistance of     resistant/refractory germ-cell tumors (GCTs), but expectancy of cure remains low. New     strategies are needed with new drugs and a sequential approach.      Patients with relapsed (but not absolutely refractory to Cisplatinum-based chemotherapy)     poor-prognosis GCTs are scheduled to receive 2 cycles combining epirubicin and paclitaxel     followed by 3 consecutive HD-CT supported by stem cell transplantation. One course will     combine Taxol, 360 mg/m² + thiotepa, 720 mg/m², followed by two ICE regimens (Ifosfamide, 12     g/m², carboplatin, AUC 20, etoposide, 1500 mg/m²).      This phase II study is designed as a Gehan method. The main objective of the study is the     complete response rate. With this aim in view, it is planned to enroll in its first step 14     patients to insure that if no complete response (CR) is noticed, study would be stopped for     inefficacy (i.e., a CR rate lower than 20%). If one or more CR are noticed, protocol     specified that up to 45 patients will be included in order to reduce the confidence interval     (CI) of the CR rate. Secondary objectives are the overall response rate (RR), the overall     survival (OS) and the progression-free survival (PFS) rates, toxicity and toxic death rate.     The statistical analysis is done in terms of intent-to-treat.   "
182436|NCT00231595|"     The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate     (50 milligrams[mg], 100mg, and 200mg per day) compared with placebo in the prevention of     migraine. The study will also assess the dose response relationship and the efficacy of     treatment with topiramate versus placebo on Health-Related Quality of Life.   "
182437|NCT00231608|"     The purposes of this study are to compare the effects of Topiramate and placebo on abdominal     visceral fat accumulation at 6 months and to evaluate the safety of Topiramate for up to 12     months of continued treatment in male patients with abdominal obesity.   "
182438|NCT00231621|"     The purpose of this study is to compare the efficacy and safety of daily topiramate versus     placebo for the treatment of obese subjects with dyslipidemia.   "
182439|NCT00231634|"     The purpose of this study is to compare the effectiveness and safety of topiramate with     placebo in the treatment of obesity and Type 2 diabetes mellitus in patients who have failed     on sulfonylurea therapy.   "
182440|NCT00231647|"     The purpose of this study is to evaluate the effectiveness and safety of a topiramate     controlled-release formulation in the treatment of obese, type 2 diabetic patients managed     with diet alone or combined with metformin.   "
182441|NCT00231660|"     The purpose of this study is to compare the efficacy (in terms of weight and hemoglobin type     A1c [HbA1c]) and safety of topiramate (96 milligrams[mg] or 192 mg daily) with placebo in the     treatment of obesity in Type 2 diabetic patients receiving metformin.   "
182442|NCT00231673|"     The purpose of the study is to evaluate the effect of topiramate on clinical and     electrophysiological parameters in patients with diabetic peripheral polyneuropathy. The     study will also evaluate the safety of topiramate in this patient population.   "
182443|NCT00231686|"     The purpose of this randomized, controlled trial was to determine whether a (and if so which)     physical conditioning program is effective to improve health status, physical activity, and     quality of life in patients with cystic fibrosis. A positive effect of physical conditioning     was expected.   "
182444|NCT00231699|"     Hypothermia leads to increased morbidity and mortality. Heat loss mainly occurs during     anesthesia and surgery. Therefore prevention of hypothermia in pediatric patients undergoing     general anesthesia is very important. However, there is very little information about     effectiveness of various insulating materials used in the operating room.      Objective: To compare the effectiveness of cotton and plastic for prevent intraoperative     hypothermia in pediatric patients.   "
182652|NCT00233480|"     The goal of the investigators' study is to further understand the potentially beneficial     effects of statin therapy in patients with heart failure. It is hypothesized that statins     will 1) increase the heart's pumping ability 2) improve functioning of the sympathetic     nervous system and 3) decrease immune activation in heart failure.   "
182445|NCT00231712|"     The purpose of this study is to conduct an analysis of the influences of        1. conventional chemotherapy        2. high-dose chemotherapy followed by autologous stem cell transplant        3. high-dose chemotherapy followed by allogeneic stem cell transplant on the recovery of          the immune system.      Detailed analysis will help to better understand the pathways of recovery of the immune     system following chemotherapy as well as the pathways of recovery of the immune system     following autologous or allogeneic stem cell transplantation.   "
182448|NCT00231751|"     Existing data support the concept that a genetic predisposition for inhibitor development     exists. The aim of the Malmö International Brother Study (MIBS) is to evaluate genetic     factors associated with the development of inhibitory antibodies in patients with hemophilia.   "
182449|NCT00231764|"     To determine the renal function, as expressed by the glomerular filtration rate at 12 months,     in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and     corticosteroids as mainstay immunosuppression in combination with low-dose cyclosporine,     tacrolimus, or sirolimus, and compare it to that of renal transplant recipients receiving     standard immunosuppression with mycophenolate mofetil, normal dose cyclosporine and     corticosteroids.   "
182450|NCT00231777|"     A new intravenous medication is being tested for the prevention of the nausea and vomiting     that occurs after surgery. This new medication is being compared to another intravenous     medication that is already available to patients for this indication.   "
182451|NCT00231790|"     Overactive bladder is very prevalent in postmenopausal women. The current study is designed     to investigate whether a new drug may offer safe and effective treatment.   "
182452|NCT00218790|"     A major component of this study is to test a novel application for a safe, non-pharmacologic,     cost-effective intervention that is already in use in clinical practice - using cool     dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis     patients. We will also evaluate its effects on selected sleep-related physiologic,     psychological, behavioral, and general health outcomes.   "
182453|NCT00218803|"     To determine if teaching rural children with asthma and their parents about appropriate     medication use, asthma triggers unique to a rural setting and increasing access to medical     care will result in a decrease in emergency department visits.   "
182454|NCT00218816|"     To determine if teaching parents and children to identify the child's asthma symptoms early     and if teaching the appropriate use of a nebulizer will result in a decrease in emergency     department visits.   "
182455|NCT00218829|"     The purpose of this study is to registrate long time clinical and histological treatment     response of basal cell carcinoma (BCC) lesions treated with one or two procedures of     dimethylsulfoxide supported 5-aminolaevulinic acid photodynamic therapy (DMSO-PDT).   "
182456|NCT00218842|"     As designs of existing outcome studies are disparate and do not always relate well to a     Swedish context, the need for further studies is obvious. Also, an empirical theory drawn     from the best practice supporting autonomy and wellbeing for clients in a nursing home     setting has not yet been fully depicted. The study described below intends to fill a gap in     knowledge related to the effect of enhanced activities of daily living (ADL)-training,     physical, and daily activities and staff education in a nursing home setting, based on a     theory- and evidence-based intervention programme in a Swedish as well as a Nordic health     care context. The aims of the study are to describe the impact of an individually tailored     intervention program, in a nursing home setting, on:        -  Physical capacity        -  Degree of dependence in ADL        -  Long-term participation in physical and/or daily activities        -  Self-rated wellbeing   "
182457|NCT00218855|"     The purpose of this study is to test the effect of thalidomide in patients with multiple     myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor     doctor know which of these are given) in addition to the ordinary chemotherapeutic drug     against multiple myeloma. We will find out for how long time the patients will stay free of     the disease and for how long time they will live, and can evaluate whether thalidomide is a     beneficial drug against this disease.   "
182458|NCT00218868|"     The purpose of this study is to compare and evaluate the diagnostic performance of scrape     cytology using two different cytological staining techniques, and to evaluate additional     touch imprint cytology with that of histopathology of superficial basal cell carcinoma and     actinic keratosis.   "
182459|NCT00218881|"     To compare HIV testing rates in ED patients offered video-assisted informed consent off-hours     versus those referred to an HIV counselor the next business day.   "
182460|NCT00218894|"     Falls are the most serious and frequent home accident amongst elderly. Most falls occur     during walking. Vision is reduced with ageing and visual impairments affect balance.     Uncorrected visual deficits and balance problems are reported to be risk factors for falls     and fall related fractures. The present project uses a longitudinal design and aims at     assessing the impact of cataract surgery on balance and gait as risk factors for falls.   "
182461|NCT00218907|"     This study compared the educational effectiveness of a ten-minute pre-test counseling video     with the usual practice of a session with an HIV counselor.   "
182462|NCT00218920|"     The aim is to come to a consensus about how to prescribe exercise training that actually     helps overweight and obese people. Thus, the present study determines the effects of several     types of exercise training to define the one with the largest effect with the least effort.   "
182511|NCT00224926|"     To explore carrier and infection status of T.tonsurans tinea capitis and characterize the     host-pathogen interaction as it relates to the disease presentation. The general hypothesis     for this study is as follows: the type of genotypic and phenotypic variant to which a child     is exposed accounts for the presentation status observed in Trichophyton tonsurans     infection.The global outcome of this investigation is to reveal potential new drug targets     designed to improve treatment outcomes in these children.   "
182491|NCT00224666|"     The pains chronic neurogeneses remain difficult to treat whatever are their origin and their     localization. The pharmacological therapeutic arsenal answers only partially the     symptomatology often very invalidating which these chronic painful patients present. Electric     stimulations of the central nervous system currently validated, in particular of the     posterior cords of marrow made a significant improvement in a certain number of indications.     Nevertheless, considerable patients are not relieved significantly, in particular those     presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It     is within this framework that recently the stimulation of the sensorimotor cortex developed.      Principal objective: evaluation of the technique of stimulation under cortical on neuropathic     pains .   "
182492|NCT00224679|"     Experimental and epidemiologic studies have suggested that aspirin intake reduces the risk     for colorectal cancer. In the APACC study we randomly assigned 291 patients to daily Aspirin     or Placebo for 4 years. However, the available data are not sufficient to serve as the basis     for firm recommendations   "
182463|NCT00218933|"     Introduction: Moderate-intensity endurance-training is known to reduce symptoms, increase     exercise tolerance, and improve quality of life in patients with chronic heart failure. The     training benefits have mainly been attributed to adaptations in the peripheral circulation     and skeletal muscle rather than to adaptations in cardiac performance. However attenuation of     left ventricular (LV) remodelling has been documented in some studies. The effects of high-     vs. moderate exercise-intensity on LV-remodelling and endothelial function in patients with     post-infarction heart failure are not definitively established and were studied in the     present study.      Methods: Patients with post-infarction heart failure (45-87 yrs, 22-males, 5-females, all     received b-blockers and ACE-inhibitors, EF 29%, peak oxygen uptake 13 ml/kg/min) were     randomized to 12-weeks, 2-3 times per week, of either moderate exercise-intensity (70% of     peak heart rate), high-intensity interval-training (95% of peak heart rate) or to a control     group that received advise from their regular doctors. Patients in the two exercise-groups     covered similar distance on the treadmill at each exercise-session so that only     exercise-intensity differed; i.e. the duration of exercise was longer in the     moderate-intensity group. Ultrasound was used to assess LV-dimension and function (including     Tissue Doppler Imaging, TDI) and endothelial function in the brachial-artery.   "
182464|NCT00218946|"     Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is     inserted?   "
182465|NCT00218959|"     In this study we want to compare Narrative Exposure Therapy to Treatment as Usual for     traumatized refugees and asylum seekers in the Mid- Norway region. Clinicians in psychiatric     outpatient clinics will deliver the two conditions to asylum seekers and refugees that     qualifies for Posttraumatic Stress Disorder. We will investigate if refugees and asylum     seekers will improve more with Narrative Exposure Therapy or Treatment as Usual, and if there     will be any differences between improvement for asylum seekers compared to improvement for     refugees with residential status.   "
182466|NCT00218972|"     Endurance training has a documented effect on hypertension. However, only low to moderate     training intensity has so far been studied. High aerobic intensity should, from physiological     considerations, prove more effective in also reducing high blood pressure. The present study     is a randomised comparison of high versus moderate intensity versus training in groups, and     general advice on 24 hour blood pressure in hypertensives. The training period is 12 weeks,     with follow-up after 1 year. Maximum oxygen uptake, quality of life, left ventricular     function and blood vessel reactivity are also measured.   "
182467|NCT00218985|"     The aim is to evaluate the effect of exercise training upon endothelial function in the     mammary artery of patients who are scheduled for CABG, as well as study the functional     properties of single cells isolated from a small biopsy of the left ventricle obtained during     surgery.   "
182468|NCT00218998|"     To see how fast and how much physical training can reduce risk factors related to metabolic     syndrome   "
182469|NCT00219011|"     This study was designed to determine if patients, who have both high blood pressure and heart     failure and are currently receiving drug treatment for heart failure, have an improvement in     their heart failure signs and symptoms and other indicators of heart failure after being     treated with aliskiren on top of their current heart failure treatment. Aliskiren is an     investigational drug; its safety will also be evaluated in this trial.   "
182470|NCT00219024|"     To demonstrate the efficacy and safety of aliskiren given to patients with essential     hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with     hydrochlorothiazide (HCTZ)   "
182471|NCT00219037|"     Assess the long-term safety and tolerability of aliskiren, with the optional addition of     HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and     protect against end organ damage.   "
182472|NCT00219050|"     To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based     regimen in the treatment of severe hypertension   "
182473|NCT00219063|"     To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.   "
182474|NCT00219076|"     To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in     combination with amlodipine 5 mg in patients with essential hypertension not adequately     responsive to amlodipine 5 mg.   "
182475|NCT00224458|"     To characterize the risks (safety and tolerability), effectiveness (continued viral load     suppression and CD4 changes), and benefits (safety, tolerability, adherence, general     satisfaction with the treatment regimen and QoL), of switching from a Combivir (BID) /     efavirenz (QD) regimen to an all QD regimen of Truvada/efavirenz.   "
182476|NCT00224471|"     Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different     commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged     10-17 years, determined by ELISA. Absence in significant variation for both parameters among     the tested lots was hypothesized.   "
182477|NCT00224484|"     Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between     the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study     period (up to month 12).      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
182478|NCT00224497|"     The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it     has on the symptoms of mild to moderate Alzheimer's disease. SB-742457 is a new treatment     which is thought to increase the levels of certain chemicals in the brain that are often     decreased in patients with Alzheimer's disease.   "
182479|NCT00224510|"     This is a study that, in the first 16 weeks, investigates whether lamotrigine versus placebo     offers effect on depressive episodes for patients with bipolar disorder (also known as manic     depressive disorder) who use lithium. In the following 50 weeks it is investigated whether     these patients experience effect on their depressive and/ or (hypo)manic episodes.   "
182480|NCT00224523|"     Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active     control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with     perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper     airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by     house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal     congestion, rhinorrhea and/or nasal itching.   "
182481|NCT00224536|"     After successful percutaneous coronary intervention (PCI) for acute ST-segment elevation     myocardial infarction, 60 patients were randomly assigned to either a control group (n=30)     that received optimum postinfarction medical treatment, or a bone-marrow-cell group (n=30)     that received optimum medical treatment and intracoronary transfer of autologous bone-marrow     cells 4·8 days (SD 1·3) after PCI. Primary endpoint was global left-ventricular ejection     fraction (LVEF) change from baseline to 6 months’ follow-up, as determined by cardiac MRI.     Image analyses were done by two investigators blinded for treatment assignment. Analysis was     per protocol.      Global LVEF at baseline (determined 3·5 days [SD 1·5] after PCI) was 51·3 (9·3%) in controls     and 50·0 (10·0%) in the bone-marrow cell group (p=0·59). After 6 months, mean global LVEF had     increased by 0·7 percentage points in the control group and 6·7 percentage points in the     bone-marrow-cell group (P=0·0026).      Transfer of bone-marrow cells enhanced left-ventricular systolic function primarily in     myocardial segments adjacent to the infarcted area. Cell transfer did not increase the risk     of adverse clinical events, in-stent restenosis, or proarrhythmic effects.   "
182482|NCT00224549|"     The purpose of this study is to assess the efficacy of two different treatment regimens for     treating resistant hypertension previously uncontrolled with at least 3 antihypertensive     treatments. The study hypothesis is that these two regimens (one based on increasing     diuretics and the other based on increasing renin angiotensin system blockage) may not differ     in terms of efficacy.   "
182483|NCT00224562|"     The RATIO registry is a French registry designed by a multidisciplinary group to collect data     on opportunistic and severe bacterial infections and lymphoma in patients treated with TNF-a     antagonists ( infliximab, etanercept and adalimumab). A total of 486 medical units in     metropolitan France participate in the RATIO registry. All diagnosis are retained after     validation by 2 qualified infectious disease or haematologist physicians (on the basis of the     standardized case report form, the hospitalisation summary, and the microbiological and     radiological results). Risk factors for developing these conditions when treated by TNF-a     antagonists will be identified in a case control study. Incidence of these diseases will be     calculated.   "
182484|NCT00224575|"     Despite the effectiveness of beta-blockers and antiplatelet agents for secondary prevention     of coronary heart disease, this treatments are underused in the elderly because of diagnosis     uncertainty and underuse of efficient treatment.      in a first time, diagnosis reassessment with invasive technique if necessary. in a second     time, treatment reassessment.   "
182485|NCT00224588|"     We assessed the effects of the N Methyl aspartate receptor antagonist Ketamine on long-term     post thoracotomy pain. We hypothesized that ketamine could prevent supersensitization of the     central nervous system involved in this chronic neuropathic pain.   "
182486|NCT00224601|"     The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to     increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with     HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.   "
182487|NCT00224614|"     The allograft of marrow in its technique of reference (myélo-ablative (MA) condition by     cyclophosphamide and total body irradiation (TBI) with strong amounts) therapeutic is     recognized acute myeloid leukaemia (AML) of the adult for the patients of less than 55 years,     because it offers chances of cure higher than chemotherapy or the auto-graft. However,     mortality related to the traditional graft is approximately 30% to 1 year. The recent use of     the non-myélo-ablative graft (NMA), in which the anti-leukaemia effect rests exclusively on     the allogenic effect graft-versus-leukaemia makes it possible to obtain among patients of     more than 55 years in complete reemission (CR), survivals without relapses comparable with     the traditional allograft among patients of more than 35 years. The major interest of NMA     graft is to reduce early mortality related to the graft. This reduction should be all the     more significant as the patient is younger, and thus bring to a better survival. There is     not, at the present hour, of prospective comparative study of the two procedures of graft.     Taking into account the results observed after NMA graft among patients of more than 55     years, and taking into account the toxicity of the standard graft between 35 and 55 years, it     is essential to now compare the 2 approaches among patients who do not have a     counter-indication for one or the other, in the age bracket where the toxicity of the     traditional graft is highest.   "
182488|NCT00224627|"     Capsule endoscopy (CE) is a safe and effective tool for the assessment of obscure     gastrointestinal bleeding (OGIB). However, its real efficacy and its position in the     diagnostic algorithm of OGIB vs. push enteroscopy (PE) remain unknown since in previous     studies both techniques were performed in all included patients The purpose of this protocol     is to conduct a randomized prospective controlled trial in patients with OGIB comparing a     strategy based on CE or PE followed by the alternative exploration only when the first line     exploration was negative. The main outpoint of this study concerns the diagnostic yield of     the two explorations. Second endpoint concerns the clinical relevance of the two strategies     tested (CE ± PE vs. CE ± PE) in terms of diagnostic yield, clinical outcome, therapeutic     impact and added explorations   "
182489|NCT00224640|"     Friedreich ataxia, an autosomal recessive condition, ascribed to frataxin gene expansion, has     been shown to result from an iron- induced injury to the mitochondrial respiratory chain.     Buffering free radicals with short-chain quinones (Idebenone) protects the patients against     cardiomyopathy but not CNS involvement. Removing CNS iron should limit the impact of the     neurological symptoms of the disease.   "
182490|NCT00224653|"     To assess the potential benefits on mechanical ventilation plateau pressure of pressure     controlled mode versus volume controlled mode for laparoscopic bariatric surgery in obese     patients (BMI > 35). High plateau pressures encountered in obese patients due to their     reduced pulmonary compliance could be lowered using pressure controlled mechanical     ventilation.   "
182512|NCT00224939|"     Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night)     and renal functional reserve and wether non-dippers (those whose blood pressure does not     decrease at night) can be modulated to dippers with potassium treatment.   "
182513|NCT00224952|"     The purpose of the study is to examine the individual metabolic profiles of pediatric     patients receiving carbamazepine or valproate therapy, in an attempt to determine identities     of the reactive metabolites or, alternatively, the identities of those metabolites that serve     as potential precursors to reactive species.   "
182494|NCT00224705|"     The purpose of this study is to improve the survival rate of those patients with acute     fulminant hepatitis through treatment with the MARS® extra-corporal liver-purification system     by:        1. Reducing the number of patients who die before a graft is available        2. Increasing the chances of survival without a liver transplant        3. Reducing the pre- and post-operative mortality in transplant patients   "
182495|NCT00224718|"     Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to     propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5     cm in diameter.      The aim of the study is to compare the mortality and the occurrence of severe general,     vascular and local complications in two groups of patients treated by either by open surgery     or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary     endpoint are respectively the survival without severe complications and minor morbidity.   "
182496|NCT00224731|"     ADHD is often associated with sleep difficulties. Attention-deficit/hyperactivity disorder     (ADHD) is the most common problem presented to children mental health services. The disorder     affects approximately 5 % of school-age children. The core symptoms of this disorder include     varying degrees of inattention, impulsiveness and restlessness.      In addition to the core symptoms, ADHD is associated with other problems (e.g. academic     underachievement, poor social relations and sleep disturbances).      Despite clinical observations of sleep problems in children with ADHD, there is little     empirical research on this topic. The prevalence, type of sleep problems, and significance of     these sleep disturbances in children with ADHD remain undocumented.      The objective is to determine the relationship of sleep problems to attention     deficit/hyperactive disorder, comorbid disorders, and the effect of stimulant treatment.   "
182497|NCT00224744|"     The purpose of this study is to evaluate the decrease of post-operative morbidity in inguinal     lymphadenectomies realised for vulvar tumors and inferior limb skin tumors by use of     Ultracision with regard to classical operative techniques.   "
182498|NCT00224757|"     In this multi centre pilot study we will perform TEE in patients with AF who are eligible for     VKA treatment. TTE will be used as pre-screening: if TTE shows left atrial abnormalities or     aortic plaque, patients will be excluded from randomisation. TEE will be performed in all     other patients to detect or exclude complex aorta plaques or signs of left atrial stasis.     Three hundred patients who do not have these features on TTE will be randomly assigned to     treatment with aspirin or VKA. Follow-up will be 1 year.   "
182499|NCT00224770|"     The purpose of this trial is to determine the safety of using a combination of minimally     invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES     arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE     intention to treat subjects represent the hypothesized test group. The ICES cohort is to be     analyzed separately.   "
182500|NCT00224783|"     The primary objective of the study was to investigate the safety and tolerability of CAIV-T     liquid formulation in healthy Japanese male adults.   "
182501|NCT00224796|"     The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure®     (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot. The     primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete     wound closure. Secondary objectives include evaluating the acceleration of wound closure,     facilitation of surgical closure, incidence of foot salvage, and incidence of wound     complications.   "
182502|NCT00224809|"     The Transesophageal Echocardiography (TEE) Surgical Treatment of Ischemic Heart Failure     (STICH) ancillary study will define the mechanism(s) of functional mitral regurgitation (MR)     by TEE in patients with ischemic cardiomyopathy, and the impact of therapy (medical, coronary     artery bypass grafting [CABG], or CABG plus surgical ventricular restoration [SVR]) on     mechanism and severity of MR. Severity of the effect of functional MR on clinical outcomes     will also be examined. The TEE STICH study will address four specific aims that will focus on     defining the following: 1) the mechanism(s) of functional MR in ischemic cardiomyopathy; 2)     the effect of therapy on the mechanism and severity of functional MR; 3) myocardial viability     on functional MR and its response to treatment; and 4) the effect of MR on prognosis in     ischemic cardiomyopathy.   "
182503|NCT00224822|"     The primary goal of this study is to assess the effect of aripiprazole on patients who     developed metabolic syndrome while taking other second generation antipsychotic medications.   "
182514|NCT00224965|"     This proposal will conduct a prospective examination of the clinical course (intensity,     content and duration) of tobacco (nicotine) abstinence effects in male and female smokers who     are either heavy/light alcohol drinkers with/without depressive symptoms.   "
182515|NCT00224978|"     Chloroquine is a strong lysosomotropic and DNA-intercalating agent in experimental studies     (Neurosurgical Focus 14(2): February, 2003) and an open-label clinical trial the     investigators have demonstrated a strong adjuvant effect of chloroquine on the therapy of     malignant gliomas. This study will assess in a randomized, placebo-controlled, double-blind     study the effects of chloroquine as adjuvant to the conventional therapy of Glioblastoma     Multiforme.   "
182504|NCT00224835|"     The principal objective of the study is to evaluate the effectiveness of a widely used     complementary medicine intervention, mindfulness-based stress reduction (MBSR), in which     mindfulness meditation and yoga are the principal components in the treatment of a chronic,     often fatal illness that affects tens of millions of Americans. The investigators propose to     conduct a single center randomized controlled trial in which 150 patients will be assigned to     either a mindfulness meditation condition, a disease education control condition, or a     stress-monitoring usual care control condition. They will test the following specific     hypotheses:        1. In comparison to either of the control conditions, significantly more coronary artery          disease (CAD) patients in the mindfulness meditation condition will demonstrate          reductions in mental stress-induced ischemia.        2. The ratio of low-to-high frequency of spectral power in heart rate variability during          ambulatory monitoring will be significantly decreased following the participation in a          stress reduction program compared with those in a disease education or usual care          condition.        3. Patients in the mindfulness meditation condition will report greater improvement in          quality of life (i.e., reductions in general psychological symptomology, anger, anxiety,          depression, and daily stress, along with increases in optimism and stress coping          efficacy) than patients in either of the control conditions.        4. Day-to-day variability in self-reported mental stress will be inversely related to          day-to-day stress coping efficacy in the entire sample and time spent in mindfulness          practice in the active treatment condition, and these relationships will be maintained          over a 3-month follow-up.        5. Patients with CAD and mental stress ischemia who show an *abnormal peripheral artery          response during baseline studies will show a significant improvement after mindfulness          intervention.             -  Abnormal responses will be defined as peripheral arterial tonometry (PAT) tracings               that decrease greater than 20% in amplitude during mental stress.   "
182662|NCT00233610|"     The aim of the study is to investigate the efficacy of different dosing and scheduling of     Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in     patients with prostate cancer.   "
182505|NCT00224848|"     This study addresses the challenges associated with implementation of clinical practice     guidelines (CPG's) and is motivated by our interest in gaining insight regarding the     following general research questions about CPG implementation:      A. Can physician adherence to complex CPGs be promoted by use of a hand-held computerized     decision support tool providing patient-specific recommendations, documentation, and drug     dosing assistance? B. Will increased adherence to CPGs reduce variation in management by age,     gender and race/ethnicity such that disparities in healthcare are reduced or eliminated? C.     What are the cost implications of using PDA-based technology to promote CPG adherence?      This randomized, controlled, unblinded, practice-based trial will address these research     questions by testing the following hypotheses in a 2 year behavioral intervention period:        1. The absolute proportion of patients that is treated appropriately with respect to          lipid-lowering drug therapy within 4 months after testing will be increased by a net of          at least 9% by the intervention as measured in baseline and follow-up independent          cross-sectional samples of eligible patients (primary endpoint).        2. The absolute proportion of patients that is treated to the appropriate low density          lipoprotein cholesterol (LDL-C) goal during follow-up of the baseline cohort of eligible          patients is increased by a net of at least 12% by the intervention (secondary endpoint).        3. The proportions of eligible patients that are appropriately screened, risk-stratified,          and counseled regarding therapeutic lifestyle changes are increased by the intervention          (tertiary endpoints).        4. The intervention effect in subgroups defined by disease status (CVD, diabetes or          neither), age, gender, and race/ethnicity reduces any disparities observed at baseline          (exploratory analyses).        5. In addition, we will estimate the marginal cost effectiveness of the intervention for          the primary endpoint.      The aims were modified in Year 1 to include an attention control group to enable evaluating     and testing the impact of strategies to improve adherence to the recently released JNC 7     guideline by testing the following hypotheses:        1. The absolute proportion of patients that is treated appropriately with respect to blood          pressure lowering drug therapy will be 10% greater in intervention practices than in          comparison practices as measured in follow-up independent cross-sectional samples of          eligible patients (primary endpoint).        2. The absolute proportion of patients that is treated to the appropriate blood pressure          goal during follow-up will be 10% greater in the intervention practices (secondary          endpoint).        3. The intervention effect in subgroups defined by disease status (CVD, diabetes or          neither), age, gender, and race/ethnicity reduces any disparities observed at baseline          (exploratory analyses).        4. In addition, we will estimate the marginal cost effectiveness of the intervention for          the primary endpoint.   "
182506|NCT00224861|"     The specific goals of this project are to (1) refine the Home Automated Telemanagement (HAT)     program according to the JNC 7 Report based on focus group review conducted by the key     personnel, primary care providers, and patients and to fully implement the multidisciplinary     model for hypertension telemanagement in African Americans as an adjunct of ambulatory care     and (2) evaluate in a randomized clinical trial the impact of HAT on hypertension care     delivery and on patients' clinical outcomes using both clinic- and patient-level variables.     The comparison will be made with the standard of hypertension care recommended by the JNC 7     Report.      The following primary hypothesis related to clinic-level outcomes will be tested: Use of HAT     will be associated (1) with improved proportion of treated patients who achieve blood     pressure goals meeting JNC 7 recommendations, and (2) with a significant reduction in     systolic and diastolic blood pressure. Researchers will also explore the impact of HAT on     physician awareness and use of the hypertension treatment guidelines promulgated by the JNC 7     Report.      The following secondary exploratory hypothesis related to patient-level outcomes will be     evaluated: The HAT program will have a positive impact on behavioral and cognitive factors     that play an important role in the process of patient self-management, including hypertension     treatment self-efficacy, health locus of control, health beliefs, and hypertension knowledge.     Researchers will also investigate the impact of HAT on patients' compliance with     multi-component treatment plans (including adherence to medication regimens and therapeutic     lifestyle changes) and explore the effect of the HAT system on patients' ability to reach     dietary, physical activity, weight control, and sodium consumption goals recommended by the     JNC 7 Report.      During this study researchers will explore the impact of HAT on patient satisfaction with     medical care, health-related quality of life, and health services utilization. Researchers     will also assess acceptance of the HAT system by both patients and providers. Finally,     researchers will perform a cost-effectiveness analysis of using the HAT system for     hypertension control.   "
182507|NCT00224874|"     The study is a randomized Phase II, four arm treatment trial. The primary purpose of the     study is to define new agents with promising activity against acute graft-versus-host disease     (GVHD) suitable for testing against corticosteroids alone in a subsequent Phase III trial.   "
182508|NCT00224887|"     Primary Hypothesis Children whose mothers receive the FBC sessions will have significantly     lower BMI one year after the intervention compared to control group children whose families     receive an active placebo control.      Secondary Hypotheses In families that receive the FBC, household availability of fruits and     vegetables will increase, and availability of high fat foods will decrease, as measured by     multiple household food inventories, compared to control group families exposed to an active     placebo intervention.      Household level of food security, mothers' food purchase motives and family food interaction     will influence the effects of the FBC on household food supplies.   "
182509|NCT00224900|"     During this phase of the study, a focus group will be conducted with young adolescents     perinatally infected with HIV and with their caregivers to develop and evaluate the content     of the proposed intervention. The purpose of the focus groups is to identify key issues and     challenges that often face young adolescents perinatally infected with HIV and their     caregivers as well as to elicit suggestions to enhance the feasibility and acceptability of     the proposed intervention. The focus groups will be audio recorded and transcribed and     reviewed by all involved in future protocol development. Themes will be pulled directly from     the focus groups to guide examples and areas of emphasis in the intervention. In addition,     proposed measures will be administered to the adolescents and their caregivers and assessed     for appropriateness for this population.   "
182510|NCT00224913|"     Total knee arthroplasty (TKA) is performed more than 300,000 times a year in the United     States, most often for osteoarthritis (OA). While pain is predictably reduced, function does     not typically ever reach that of age-matched, uninjured subjects. Quadriceps weakness has     been implicated in the development and progression of knee OA and is a significant problem     after TKA. Voluntary exercise has been ineffective at restoring quadriceps strength after     TKA. The aims of this study are: 1) to assess the effectiveness of high-level neuromuscular     electrical stimulation as an adjunct to ongoing intensive, early rehabilitation in restoring     quadriceps strength and improving the functional outcome after primary TKA, and 2) to     identify the physiological and morphological bases for improvements in quadriceps strength     and functional outcome.   "
182516|NCT00224991|"     The purpose of this study is to investigate the efficacy of systematic education     (osteoporosis school) on fall frequency, compliance and quality of life of a group of     patients more than fifty years of age.      Hypothetically, systematic information can increase compliance to the medical treatment,     decrease the frequency of falls and increase the quality of life.   "
182517|NCT00225004|"     The primary purpose of the retrospective study is to determine the incidence of osteoporosis     in women with previous Colles Fracture. Secondly, to determine to which extent Colles     Fracture has led to a diagnosis and/or treatment of osteoporosis.      The primary purpose of the prospective study is to determine the incidence of osteoporosis in     women with an actual Colles Fracture. Secondly, to investigate the consistency between     prospective and retrospective data.   "
182518|NCT00225017|"     The purpose of this study is to evaluate the change in brachial artery reactivity in     HIV-infected subjects with elevated lipid levels who are switched to an atazanavir containing     antiretroviral regimen   "
182519|NCT00225030|"     Observational study of life time prognosis for persons medically treated for arterial     hypertension, according to current WHO-guidelines.   "
182520|NCT00225043|"     The study involves research, the purpose of which is to compare three different drug mixtures     (Epinephrine, Phenylephrine 25 µg, or Phenylephrine 50 µg). Specifically, how long each     medicine lasts will be studied.   "
182521|NCT00225056|"     In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly     docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent     capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and     toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on     days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of     each cycle will be utilized.   "
182522|NCT00225069|"     To determine outcome and side effects following thoracoscopic sympathectomy in patients     treated for disabling isolated facial blushing and investigate if there are any significant     differences between two different routine procedures: T2 or T2-T3 sympathectomy.   "
182523|NCT00225082|"     HIV infected subjects receiving antiretroviral treatment for greater than 6 years with be     evaluated for clinical lipoatrophy and mitochondrial function after switching nucleoside     analogues from stavudine (d4T) to tenofovir treatment and after 4.      Hypothesis: Tenofovir therapy will increase peripheral fat content as assessed by DEXA and     mitochondrial function at 48 weeks.   "
182524|NCT00225095|"     The purpose of this study is to determine whether Chondrogen is a safe and effective     post-operative treatment of the knee following menisectomy (the surgical removal of all or     part of a torn meniscus).   "
182525|NCT00225108|"     Venous thromboembolism (VTE) remains the most common cause of maternal death in the developed     world. VTE includes two conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE).     DVT refers to a blood clot that has formed in a deep vein, often in the legs and/or pelvis     and PE refers to the passage of these clots into the lungs (which can be fatal). VTE is up to     10 times more common in pregnant women than non-pregnant women of comparable age. More than a     third of pregnancy related VTE occur during the 6 weeks after delivery. When compared with     vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by     three-fold.      A medication called low molecular weight heparin is sometimes prescribed during pregnancy and     after delivery to prevent VTE. However, clinical practice varies because there hasn’t been     adequate research to determine that this medication is safe and effective at preventing VTE     during this time. The potential benefits of the medication must also be weighed against its     cost and possible side effects.      The researchers are conducting a study that will assess the effectiveness and safety of low     molecular weight heparin in women who are at moderate to high risk of VTE after a cesarean     section. They will monitor these women to determine if those who received the medication have     fewer blood clots. Participants will also be monitored closely for any side effects.   "
182526|NCT00225121|"     The primary purpose of this study is to study the side effects of PF-00299804 and determine     the highest dose that can be safely administered in patients with advanced cancer.   "
182527|NCT00225147|"     Hereditary angioedema (HAE) is a genetic disorder characterized by sudden recurrent attacks     of local swelling (angioedema). These attacks are often painful and disabling, and, in some     cases, life-threatening. HAE is caused by mutations in the C1INH gene that lead to a     decrease in the blood level of functional C1INH. This multi-center study was designed to     assess the safety and tolerability, efficacy, and pharmacokinetics/pharmacodynamics of     recombinant human C1 inhibitor (rhC1INH) in the treatment of acute hereditary angioedema     attacks.      Funding Source - FDA OOPD   "
182528|NCT00225160|"     The purpose of this study is to determine whether Acetyl L-carnitine can prevent the     development of nerve damage, known as neuropathy, in individuals taking anti-HIV drugs over a     48-week period. In addition the safety and tolerability of Acetyl L-carnitine will be     assessed.      This study compares the use of Acetyl L-carnitine or placebo (a dummy drug) in the prevention     of nerve damage. The current standard of care is to use painkillers to manage the pain, with     little or no effect. The possible beneficial effects of taking Acetyl L-carnitine is to     prevent nerve damage as a result of anti-HIV medication.      The main purposes of the trial are:        -  to look at the differences in between those on Acetyl L-carnitine versus those on          placebo        -  to look at the effect on state of your nervous system in the two treatment groups by          measuring nerve activity        -  to learn more about the safety and tolerance of Acetyl L-carnitine   "
182529|NCT00225173|"     Patients with 3 or more adverse prognostic factors have a higher relapse rate. Significant     anti-tumor activity in Hodgkin's lymphoma has been reported with two new drugs:gemcitabine     and vinorelbine. The introduction of these new agents with their different mechanisms of     action into the Stanford V regimen may increase effectiveness while maintaining a favorable     toxicity profile with respect to fertility and a low risk of secondary leukemia. On this     basis, we propose a new regimen, Stanford VI, for patients with bulky and advanced HD with 3     or more risk factors.   "
182530|NCT00225186|"     The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the     treatment of endometriosis   "
182531|NCT00225199|"     The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to     placebo in the treatment of endometriosis   "
182588|NCT00225979|"     Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma     causing overproduction of growth hormone which leads to acromegaly. The objective of this     study is to assess the safety and efficacy of long-acting repeatable formulation of     octreotide and to compare it to the safety and efficacy of surgery in patients with     acromegaly who have not had any previous treatment for acromegaly.   "
182532|NCT00225212|"     Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas,     but is limited by relapse occurs in 40 to 50% of subjects.      This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose     therapy increases the event-free survival in diffuse aggressive lymphomas and low grade     lymphomas, as an alternative to the limitations of conventional therapy.      Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about     50% with very little toxicity. Rituximab is hypothesized to be a candidate for     post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen;     rituximab has impressive independent anti-tumor activity; and the antibody has little     toxicity outside of the acute administration.   "
182660|NCT00233584|"     This prospective study will evaluate the feasibility of the defined decision tree for the     treatment of asthmatic young children. Children who develop episode (=3 consecutive days) of     any troublesome lower respiratory symptoms are treated according to a strictly pre-defined     multi-steps treatment algorithm until the age of 6 years.   "
182533|NCT00225225|"     Given the high prevalence of type 2 diabetes and the 2- to 4-fold increased risk of fatal and     non-fatal coronary heart disease events in these patients, long-term glycemic control is of     great importance. TZDs improves glycemic control in patients with type 2 DM as well as     enhances their insulin-mediated glucose disposal. However, the improvement of glycemic     control seen with TZDs may be blunted in the long run by weight gain.      Previous data on weight gain during TZD therapy in patients with type 2 DM is very sparse. It     is generally assumed that an increase in adipocyte differentiation is the cause of weight     gain in association with TZD treatment which may limit their use. Increased body weight     assumed to compromise the positive effects of treatment. There is also a theoretical concern     that, with the development of new adipocytes, future weight loss may be difficult.      However, if weight gain is primarily due to failure to adjust caloric intake in proportion to     the decrease in urinary glucose loss, it is totally preventable. It has been previously shown     that improvement of glycemia favored weight gain by decreasing the energy loss in the urine     as glucose. Severity of weight gain appears to be proportional to the level of glycemic     control achieved.      The overall goal of the proposed research is to provide the experimental evidence for the     later alternative by showing that the modest weight gain that takes place in association with     effective rosiglitazone treatment of hyperglycemic patients with type 2 DM is primarily due     to its therapeutic efficacy. More specifically, by decreasing the caloric intake in     proportion to a decrease in urinary glucose loss associated with improved glycemic control,     we will be able to prevent significant weight gain following Rosiglitazone treatment. In     order to provide an optimal dietary modification that can be universally applied to     TZD-treated patients in clinical practice, we will have a group with a fixed amount of     caloric restriction per day. It will be the first randomized controlled trial of a potential     strategy for prevention of weight gain associated with thiazolidinediones.   "
182534|NCT00225238|"     The purpose of this study is to ascertain if the use of Nexium for 7 days prior to taking a     colon prep for a colonoscopy will decrease the side effects that are associated with the     colon preparation   "
182535|NCT00225251|"     This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic     disorder, a form of low-grade chronic depression. We hypothesize that patients taking     Wellbutrin XL will show greater improvement in depression symptoms and psychosocial     functioning than patients taking placebo.   "
182536|NCT00225264|"     The primary purpose of this study is to compare the effects of pioglitazone, once daily (QD),     versus glimepiride on the amount of thickening of the carotid artery.   "
182537|NCT00225277|"     The purpose of this study was to determine the efficacy of pioglitazone, once daily (QD),     compared to glimepiride on atherosclerotic disease measured by intravascular ultrasound.   "
182538|NCT00225290|"     To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.   "
182539|NCT00225303|"     The purpose of this study is to determinate the effectiveness, safety and tolerability (how     well the body accepts the drug) of an investigational Non-Nucleoside Reverse Transcriptase     Inhibitor (NNRTI) called TMC125.   "
182540|NCT00225316|"     To determine the efficacy of daily maternal acupuncture treatments in reducing the frequency     and severity of neonatal abstinence syndrome among infants born to substance-using women..   "
182541|NCT00225329|"     To determine, among healthy first time mothers who are uncertain as to when to come to     hospital in labour, if home visits by obstetrical nurses compared to telephone advice have an     impact on reducing cesarean section rate.   "
182542|NCT00225342|"     The principle objective of the trial is to compare rosiglitazone to gliclazide in patients     with type 2 diabetes mellitus and chronic stable angina to see how the subjects' angina     status changes.      Angina status will be measured via exercise tolerance testing, 24-hour ECG testing and angina     quality of life questionnaire.   "
182543|NCT00225355|"     We wish to see if the drug rosiglitazone, currently used in the treatment of type 2 diabetes,     could be used as a new treatment for angina when compared with placebo in overweight subjects     who do not have overt diabetes. The drug will be given for 3 months and the subjects will be     have their angina tested, by way of exercise testing, angina quality of life questionnaire     and 24-hour ECG monitoring before and after using the drug.   "
182544|NCT00225368|"     Insecticide-impregnated bed nets and curtains (ITN) have been shown to be effective against     malaria. However, given that most ITN studies were of limited length, researchers have     postulated the hypothesis that in areas of intense malaria transmission and due to possible     interactions with immunity development, ITN interventions may cause no effect at all or even     a long-term increase in malaria morbidity and mortality.      The overall objective of the trial is to analyse the long-term effects of ITN on child     morbidity and mortality in an area of intense malaria transmission. The specific objective is     to analyse if there is a difference in the rates of malaria morbidity and mortality as well     as in all-cause mortality in children being protected with ITNs from birth compared to     children protected with ITNs from age 6 months onwards.      The study is conducted in the Nouna Health District, in Burkina Faso, and specifically in a     sub-portion of the District under demographic surveillance since 1999. The sub-portion of the     District under demographic surveillance includes a total population of 70 000 individuals,     distributed in 42 villages and in the town of Nouna. The region is a dry Savannah     characterised by high levels of malaria transmission.      The study design entails a prospective community-based trial, with newborn children being     identified at the village level and then individually randomised to receive either     intervention A or intervention B. Intervention A is defined as ITN protection from age 0 to     59 months (i.e. protection from birth). Intervention B is defined as ITN protection from age     6 to 59 months (i.e. protection from 6 months onwards). Enrollment in the study cohort in     continued until the sample size is reached (n = 2 600, 1 300 group A and 1 300 group B).      Detailed data on morbidity is collected through means of a prospective follow up on a     sub-sample of 420 children from 6 sentinel villages (210 from group A and 210 from group B).     These 420 children are visited daily by field workers who measure their temperature. In case     of fever, field workers take a blood sample through finger prick to be analysed for malaria     parasitaemia. Treatment free of charge is organised for all children in this subsample. In     addition, these children are visited twice a year for the collection of clinical (malaria     episodes, anaemia) and parasitological (rates of malaria parasitaemia, parasite density)     parameters. Data collection on this subsample of children is meant to last from June 2000 to     December 2003. For study purposes, falciparum malaria is defined as 37.5 C or more plus at     least 5 000 parasites per micro-litre.      All-cause mortality in the overall study sample (2 600 children) are ascertained through     means of a demographic surveillance system (DSS), which regularly monitors deaths (as well as     births and migration) in the region. The causes of death are identified through means of     verbal autopsy. All children enrolled in the study are followed up through means of the DSS     from birth up to 5 years of age.      The primary study outcome will be the five-year all-cause mortality in the total number of     children enrolled in the study (2 600). Secondary outcomes will be the study of     malaria-specific mortality, clinical parameters, and parasitological parameters in a     sub-sample of the study cohort (420).   "
182589|NCT00225992|"     In this phase II study besides evaluating for safety, the primary efficacy parameter is to     evaluate the incidence of patients who have had a response to Trisenox by evidence of     increased blood counts (red, white, or platelets) and/or by decrease or transfusion     dependency. The secondary efficacy parameter is the assessment of the tolerability of the new     dosing schedule.      Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of     0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28     weeks.   "
182545|NCT00225381|"     During clinical anesthesia, it is astonishing that CO2 monitoring consists mainly of     end-tidal PCO2 to confirm endotracheal intubation and to estimate ventilation, and O2     monitoring consists of a single PO2 measurement to detect a hypoxic gas mixture. Better     understanding of how O2 and CO2 kinetics monitoring can define systems pathophysiology will     greatly enhance safety in anesthesia by detecting critical events such as abrupt decrease in     cardiac output (Q.T) by vena-caval compression during abdominal surgery, occurrence of CO2     pulmonary embolism during laparoscopy, rising tissue O2 consumption (V.O2) during light     anesthesia, and onset of anaerobic metabolism (V.CO2 is disproportionately higher than V.O2).   "
182546|NCT00225394|"     CMV viral disease negatively affects transplant patients. CMV is the most prevalent infection     in transplant patients and 3 month drug regimens to prevent the virus have been mostly     unsuccessful, usually after the drug has been stopped, the patient develops the viral     disease. Extended use of anti-viral drugs may, in fact, may lead to the development of     resistant virus. We hypothesize that extended use (12 months) of valganciclovir     (Valcyte™)will not only be efficacious but will not be associated with the development of     resistant CMV.      Sample Size: 100 patients at 3 sites have been enrolled      Patient Selection: Adult (>18 years) recipients of cadaveric or living donor kidneys,     pancreas, or combine kidney-pancreas transplants.      Immunosuppression: To be determined according to each center’s standard protocol (s).      Study Drug: Valcyte™ Days 0 – 90: All Patients, 900 mg QD      Days 91 – 365:      Group 1: 900 mg QD Group 2: 450 mg QD      Assessment of Valgancicovir (Valcyte™)Resistant CMV : Serial serum samples (at transplant, 6     weeks, and 3, 6, 9 and 12 months post-transplant) for PCR amplification and DNA sequence     analysis from detectable CMV to identify the presence of mutations within the UL97 and UL54     genes.      Other Analyses:      Additional information will be evaluated relating to the development of CMV disease,     development of ganciclovir toxicity, graft rejection or graft loss and patient death.     Preliminary information regarding the predictive value of DNA assays for the development of     CMV disease will be evaluated.   "
182547|NCT00225407|"     The purpose of this study is to investigate the processing of cannabis, and to investigate     the occurrence of effects of cannabis on the cardiovascular system and the central nervous     system; at higher levels of exposure.   "
182548|NCT00225420|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as     leuprolide, may lessen the amount of androgens made by the body. Radiation therapy uses high     energy x-rays to kill tumor cells. Giving docetaxel together with androgen ablation therapy     and external-beam radiation therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when     given together with androgen ablation therapy and external-beam radiation therapy and to see     how well they work in treating patients with high-risk localized prostate cancer.   "
182549|NCT00225433|"     In vitro fertilization (IVF) is a common procedure used to assist couples who have difficulty     conceiving a pregnancy. IVF is a process where oocytes (eggs) are retrieved from a woman's     ovaries and fertilized with sperm in the laboratory. In order to maximize the number of     oocytes that can be retrieved, a women undergoes ovarian stimulation with recombinant     follicle stimulating hormone (FSH). Typically 6-20 oocytes are retrieved, but in some cases     there is a limited response to the stimulation, producing a limited number of oocytes. This     is called poor ovarian response.      This study is designed to objectively compare two treatment regimens currently advocated in     clinical practice, but never compared directly. The purpose is to assess ovarian response to     starting treatment at the end of the preceding cycle may increase the number of developing     oocytes.   "
182550|NCT00225446|"     The main objective of this study is to validate a simplified platform of a repositioning     system in orthognathic surgery (a third generation optic repositioning system called     MicronTracker) compared with the actual clinically validated one (Orthopilot system).   "
182551|NCT00225459|"     The purpose of this study is to determine whether or not spiritual and/or religious     commitment affects mood variability and thoughts of suicide.      First we hypothesize that among patients with depressive symptoms, those who have higher     religious/spiritual (R/S) commitment will have less suicidal ideation and less mood     variability. Second, we hypothesize that higher mood variability will be associated with more     suicidal ideation. Finally, dependent on the first two hypotheses, we propose that R/S     commitment will mediate the relationship between mood variability and suicidal ideation.   "
182552|NCT00225472|"     Kidney transplantation remains limited by four problems: 1) a too high rate of delayed graft     function, 2) early loss of kidneys from chronic rejection, 3) donor kidney shortages, and 4)     the need for immunomodulating treatments. Improved cold storage methods can significantly     impact on the first 3 of these 4 major problems. The device to be tested is a modification of     the existing Viaspan organ preservation solution. The modification of this solution combines     four compounds: Bovine neutrophil peptide-1 (BNP-1), Substance P (SP), Insulin-like growth     factor-1 (IGF-1), and Nerve Growth Factor (NGF). This solution will be added to Viaspan for     preservation of donor kidneys. Preclinical data indicates that trophic factor deprivation     during cold storage is a significant and previously unrecognized mechanism of injury in cold     stored kidneys. The aim of this study is improved graft function, decreasing early graft loss     due to rejection, and decreasing the donor organ shortage.   "
182553|NCT00225485|"     Phase III study evaluating Effexor XR in elderly patients with major depression.   "
182554|NCT00225498|"     Ziprasidone is a newer drug intended for the treatment of the symptoms of schizophrenia. This     new drug may have an added benefit of being able to help with some of the difficulties in     problem solving and memory that many patients with schizophrenia experience. The present     study wants to look at ziprasidone and two other drugs frequently used to treat the symptoms     of schizophrenia (risperidone and olanzapine) to see if problem solving and memory get better     with ziprasidone treatment. Moreover, we will look at symptoms and how they change with     treatment.   "
182555|NCT00225511|"     Study Evaluating Effexor XR for Major Depression.   "
182556|NCT00225524|"     Phase III long-term safety study of Effexor XR in patients with major depression.   "
182656|NCT00233532|"     The TRAIL study was conducted to examine the effects of escalating doses of an ACE inhibitor,     trandolapril, on lowering blood pressure in Stage 1-2 hypertensive patients.   "
182597|NCT00231894|"     This is a study with an approved drug for treating type 2 diabetes, for its effects on     treating glucose and lipid abnormalities in patients being treated with olanzapine and     clozapine, and comparison of effects of this drug with another treatment lifestyle     modification. Patients who meet inclusion criteria will be treated with pioglitazone for 12     weeks. They will be evaluated for fasting glucose and lipids, glucose-tolerance tests, and     neurocognitive battery and tests of verbal memory at baseline and during treatment with     pioglitazone.   "
182557|NCT00225537|"     Open-label studies, anecdotal reports, and in vitro scientific research indicate that     4-methylumbelliferone (active ingredient of the dietary supplement Heparvit®) may prevent and     reverse the symptoms and complications of chronic infection with hepatitis B virus (HBV)and     hepatitis C virus (HCV). This effect has been observed among naïve patients as well as those     who are non-responders to interferon, commonly used as first-line therapy for HBV and HCV. In     order to scientifically address the efficacy of this 4-methylumbelliferone on chronic viral     hepatitis, a randomized, placebo-controlled, blinded study is needed.      It is hypothesized that 4-methylumbelliferone may reduce the impact and aggressiveness of HBV     and HCV upon the liver, thereby slowing the progression to potentially life threatening liver     diseases such as cancer and cirrhosis. This is a preliminary study designed to determine any     indications under controlled conditions that may warrant further detailed clinical studies.   "
182558|NCT00225550|"     N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer     progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study     will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a     protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that     subjects can tolerate.   "
182559|NCT00225563|"     The Taconic IPA, a 2,500 physician independent practice association (IPA) located in     Fishkill, New York (NY), is involved in an information technology project to improve the     quality, safety and efficiency of healthcare in the region. Over the past three years, the     organization has worked with area hospitals and laboratories to create a community wide     electronic data exchange. Currently, the Taconic IPA is in the midst of implementing a full     electronic health record in some practices and e-prescribing in other practices. The purpose     is to study the impact of an electronic health record on safety and quality measures.   "
182560|NCT00225576|"     To determine the effects of Electronic Health Record use on medication error rates in primary     care office practices.      Hypothesis: Adoption of Electronic Health Records through this program will reduce medication     errors   "
182561|NCT00225589|"     The purpose of this trial is to see if rosuvastatin will be effective in decreasing the     thickness of the walls of the arteries in the neck for people who already have some evidence     of thickening of these walls.   "
182562|NCT00225602|"     The aim of the study is to evaluate the effect of assertive community treatment in Copenhagen     in two regions compared with two regions where this treatment was not implemented. The effect     on user satisfaction, use of bed days, social network, global assessment of functioning,     substance misuse will be evaluated.   "
182563|NCT00225615|"     The primary objective of this trial is to evaluate the safety and tolerability of long-term     Phenoptin treatment in subjects with PKU.   "
182564|NCT00225628|"     Assesses physician compliance with paper-based and electronic guidelines, reminders, and     alerts for outpatient settings. Target areas for the reminders and alerts are disease     management, medication management, and interpretation of abnormal test results.   "
182565|NCT00225641|"     The aim is to conduct a prospective multicentre randomised study comparing two different     control regimens after resection for colorectal cancer stage II - III. Follow-up after     surgery for colorectal cancer is a controversial issue. The reasons for follow-up are: to     obtain a better overall survival, for scientific purposes and/or for psychological reasons     and/or as quality assessment. Meta-analyses of randomised controlled studies have lately     shown that a beneficial effect on the overall mortality could be found with intense follow-up     compared to sporadic. This study compares the regimen of CT-scan or MR scan of the liver,     control of the carcinoembryonic antigen (CEA), and CT-scan or X-ray of the lungs in two     groups with either control after 12 and 36 months, or after 6, 12, 18, 24, and 36 months. The     efficacy parameters are total and cancer-specific mortality.   "
182566|NCT00225654|"     ELUTES is a European multicenter, randomized, controlled, triple-blinded study designed to     evaluate the ability of the Paclitaxel Eluting V-Flex Plus coronary stent to reduce     restenosis in the coronary artery.   "
182567|NCT00225667|"     The purpose of this study is to determine whether irbesartan will reduce the rate of     recurrent atrial high rate episodes and the development of clinical sustained atrial     fibrillation in patients with hypertension and permanent pacemaker.   "
182568|NCT00225680|"     This trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug     Eluting coronary stent with conventional treatment for in-stent restenosis for coronary     arteries.   "
182569|NCT00225693|"     The study is intended to collect data to evaluate effectiveness and safety of drug eluting     stent devices in a dose ranging assessment.   "
182570|NCT00225706|"     The primary objective of this study of Caldolor administered to febrile hospitalized     pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a     single dose of Caldolor compared to acetaminophen (paracetamol; APAP) for the treatment of     fever as measured by the AUC Tº within the first 6 hours of treatment (as compared to a     target temperature of 98.6ºF [37.0ºC]).   "
182571|NCT00225719|"     Currently available therapies to treat Acute Coronary Syndromes(ACS) have several limitations     including; the relatively long treatment duration required before apparent significant     benefit; the inability to achieve reversal of the atherosclerotic process; and poor patient     compliance due to chronicity of therapy. This study will assess the effects of rHDL compared     with placebo on indices of atherosclerosis progression and regression as assessed with     intravascular ultrasound (IVUS) in patients after acute coronary syndromes (ACS).   "
182572|NCT00225732|"     The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative     hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of     Caldolor compared to placebo for the treatment of post-operative pain as measured by     reduction in the requirement for the narcotic analgesic, morphine, post surgery   "
182573|NCT00225745|"     The primary outcome measure for this study is plasma ghrelin level.   "
182617|NCT00233012|"     The purpose of this study is to evaluate the pharmacokinetics safety and tolerability of     topiramate in infants aged 1-24 months with refractory partial-onset seizures. Topiramate is     an antiepileptic drug approved for use in adult and pediatric patients (aged 2 to 16 years)     with refractory partial onset seizures (POS) with or without secondarily generalized     seizures, primary generalized tonic clonic seizures, or Lennox-Gastaut syndrome (LGS).   "
182574|NCT00225758|"     Two thirds or more of breast cancers are dependent on estrogen for growth. We use a number of     estrogen-blocking medicines for treatment of metastatic breast cancer. The treatment response     to these agents is unpredictable, however, and approximately one-third of patients with     metastatic breast cancer with receptors for estrogen or progesterone have no benefit from     hormonal therapy. Nearly all patients with metastatic breast cancer will eventually become     resistant to hormonal therapy despite the fact that the hormone receptors are still present.      Some cells make a different class of growth factor receptor called the Epidermal Growth     Factor Receptor. There is a growing body of experimental evidence showing that breast cancer     cells that make Epidermal Growth Factor Receptors are more resistant to hormonal therapy and     have a poorer prognosis. Several investigators have found that the Epidermal Growth Factor     Receptor can activate the estrogen receptor, even in the presence of estrogen-blocking drugs.     Growth of these cells can be slowed by blockade of both Epidermal Growth Factor Receptor     signaling and estrogen-receptor signaling. Lapatinib is a small molecule which can inhibit     two different forms of the Epidermal Growth Factor Receptor. It has been studied in people     with a number of different cancers, including breast cancer, and a safe dose and its common     side effects have been defined.      Our hypothesis is that the Epidermal Growth Factor Receptor is the dominant receptor pathway     used by breast cancers in our patients with hormone-resistant tumors. Drugs like lapatinib     which block several forms of the Epidermal Growth Factor Receptor would best be able to     reverse resistance to hormonal agents.   "
182575|NCT00225784|"     This study is designed to establish the safety and efficacy of a combination of Erbitux     (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.   "
182576|NCT00225797|"     The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone     extended release in non-cancer patients with chronic low back pain.   "
182577|NCT00225810|"     The primary objective of the clinical trial is the assessment of the acceptability of the new     Pentasa formulation - PentasaR Sachets in comparison with the reference PentasaR tablets 500     mg in children with Crohn's disease. After the screening period (which includes medical     history, physical examination, basic haematology, serum chemistry , urine analysis and stool     microbiology , PCD Activity Index )patients will receive (visit I) Pentasa sachets 1g or     Pentasa tablets 500mg for next 4 weeks according to the randomisation scheme in common dose     2× 1 g of PentasaR Sachets 1 g or PentasaR tablets 500 mg. The formulation of Pentasa will be     switched at Visit 2, patients will receive the medication for next 4 weeks. Patients will     record the acceptability of the both forms of the medication.      In 6 patients from each group (selected by the randomization), stool and urine will be taken     to assess concentrations of mesalazine and N-acetylmesalazine during Visit 2 and Visit 3.     Adverse events will be recorded during the whole course of the treatment period.   "
182578|NCT00225823|"     Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal     spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory     disorder of the upper airway that occurs following allergen exposure. The focus of this     study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered     by the pollen from trees, grasses, and weeds. Commonly referred to as 'hay fever', it is     characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery,     red eyes.   "
182579|NCT00225836|"     Dysmenorrhoea (menstrual pain) is a common complaint among women, leading to use of     analgesics, reduced quality of life, and interference with daily activities such as going to     work or school.      Transcutaneous electrical nerve stimulation (TENS) is a well established method for treatment     of pain. Several clinical studies have shown TENS treatment to be effective against     dysmenorrhoea. A TENS apparatus specifically developed for the treatment of dysmenorrhoea has     now become commercially available (OVA), but is has not been tested in clinical studies.      This study will be done to evaluate the clinical utility of treatment with OVA in women with     primary dysmenorrhoea.   "
182580|NCT00225849|"     The purpose of this study is to investigate the balance between the risks and benefits of     primary prevention by Aspirin in elderly Japanese patients with one or more     cerebro/cardiovascular risk factors   "
182581|NCT00225862|"     A 12-week clinical research study to evaluate the tolerability, efficacy and safety of     ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS     in the United States.   "
182582|NCT00225875|"     The goal of this study is to evaluate the clinical effectiveness of the rituximab at the     adults with a chronic immune thrombocytopenic purpura (>=6 months of evolution) and severe     (platelets <= 30x109/L) and candidate to a splenectomy. The objective is to obtain after a     treatment by the rituximab a satisfactory response to one year, defined by a number of     platelets higher than 50x109/L and at least 2 times superior with the persistent initial     figure without treatment during one year after the end of the treatment.   "
182583|NCT00225888|"     The purpose of this study is to compare the effect of food photography with group discussions     to the effect of regular diabetes nutrition care on people's eating habits, satisfaction with     care, self-care behaviors, and blood sugar levels. We hypothesize that, by photographing all     meals and snacks (i.e., keeping 'photo journals') and participating in discussions about the     photographs with peers and a nutritionist, people with diabetes will become aware of their     behaviors and develop concrete strategies to meet nutritional recommendations.   "
182584|NCT00225901|"     The purpose of this study is to determine whether recombinant human hepatocyte growth factor     is safe and effective in the treatment of fulminant and late-onset hepatic failure.   "
182585|NCT00225914|"     To evaluate the efficacy, safety, and tolerability of Paroxetine treatment in perimenopausal     and postmenopausal women who present with menopause-related symptoms after discontinuing     hormone therapy (HT), in the presence or absence of concomitant symptoms of depression or     anxiety.   "
182586|NCT00225927|"     The purpose of this study is to determine whether a new surgical technique (radioguided seed     localization) for localizing nonpalpable breast tumours is better than the standard technique     (needle localization).   "
182587|NCT00225966|"     The purpose of this study is assess the long-term safety and effectiveness of the InterStim     tined lead using a minimally invasive approach.   "
183519|NCT00246012|"     The purpose of this study is to evaluate the safety and effectiveness of the intetumumab,     alone and in combination with dacarbazine, in patients with stage 4 melanoma.   "
182590|NCT00231803|"     Advanced kidney disease with it's associated heart and blood vessel problems are becoming     more frequent. These problems markedly affect length and quality of life and cost a lot to     treat. Treatments are known that can prevent development of advanced kidney and heart     disease. These treatments are not being optimally applied in the current health system. This     study aims to identify people with relatively early stage chronic kdiney disease. With the     participation of these people, the study will test whether a nurse co-ordinated clinic     involving a medical kidney specialist, applying the known treatments, can reduce or delay the     onset of advanced kidney disease and heart and blood vessel problems such as heart attack,     stroke and death, to a greater extent than usual care. The study will also address issues of     costs associated with care and illness. The nature of the care provided by the heatlh care     professionals will be studied to see how best to achieve good health outcomes.   "
182591|NCT00231816|"     The purpose of this study is to determine whether the investigational zoster vaccine has a     comparable immune response (the body's ability to protect against disease) and safety profile     when given concomitantly with another vaccine.   "
182592|NCT00231829|"     Expression of COX-II has been identified in many types of human cancers. Uterine cancer is     the most common gynecologic cancer in the US and there has been an increase in uterine cancer     deaths over the past decade mainly due to the difficulty in treating recurrences in the more     aggressive histologic types. The study co-investigators have also identified COX-II     expression in grade 2 and 3 endometrioid-type, clear cell, and papillary serous types of     uterine cancers. Upregulation of COX-II may control the cell cycle by regulating the     proliferative capacity of neoplastic endometrial cells. This is a Phase II pre-post     intervention comparison study in eligible patients looking at the effects of a COX-II     inhibitor on uterine cancer. The patients whose endometrial biopsy shows grade 2 or 3     endometrioid-type, clear cell, and papillary serous types of uterine cancers will be put on a     selective COX-II inhibitor, Celebrex (Celecoxib) until the day of their surgery. We     hypothesize that Celecoxib will downregulate the expression of COX-II in these tumor types as     it does in other similar tumors. We also hypothesize that apoptosis, as measured with the     TUNEL assay, will be increased in areas with less COX-II expression and should be inversely     proportional to cellular p21 expression. We hypothesize COX-related gene expression will be     altered thus suggesting an up- or down-regulation of these genes in the end-organ tissue.     Documenting downregulation of COX-II enzyme and altered gene expression in endometrial     carcinoma after treatment with Celecoxib may result in further prospective studies using     selective COX-II inhibitors as effective, well-tolerated chemotherapeutic agents in these     uterine cancers that are resistant to many current therapies.   "
182593|NCT00231842|"     The optimal sequence and /or modality for adjuvant therapy in the management of MMT clearly     remains to be established. The rationale for the protocol is to sandwich pelvic radiation     with chemotherapy to decrease distant metastasis.      The concept of sequential chemotherapy/radiation therapy/chemotherapy has been previously     reported. The chemotherapeutic agents employed in that trial were cisplatin and epirubicin     with a reported survival of 74% in patients with Stage I and II MMT with a median follow-up     period of 55 months. Toxicity was reported as tolerable and 98% of patients were able to     complete their therapy. Sequential chemotherapy/radiation/chemotherapy has also been     investigated in other high risk uterine tumors with a propensity for both distant and local     recurrence. A retrospective review of 23 patients treated with radiation sandwiched between     paclitaxel/platinum chemotherapy in patients with uterine papillary serous carcinomas found     5/23 (22%) to have recurred with a median PFI of 16.6 months (range 12.1 - 23 months). The     median follow-up was 21 months (range 10-45 months). Of the patients remaining disease-free,     the median PFI was 21.4 months (range 10-15 months). Toxicity was acceptable and the regimen     was well tolerated. A prospective trial of this regimen is presently ongoing and without     unexpected toxicity or morbidity.      The proposed study will sandwich radiation between the two most active chemotherapeutic     agents for MMT identified to date (ifosfamide/cisplatin). By doing so, we attempt to decrease     both local and distant recurrence, which may translate into an improved progression free     interval and possibly even extend survival.   "
182594|NCT00231855|"     The primary aim of this study is:        -  To determine the overall clinical response rate of weekly Topotecan and Taxotere in          women with recurrent ovarian, primary peritoneal, endometrial and uterine cancers.      The secondary aims of this study are:        -  To evaluate the safety and tolerability of the combination therapy with weekly Topotecan          and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial or          uterine cancers.        -  To determine the progression free survival and overall survival in women treated with          weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal,          endometrial and uterine cancers who have been previously treated with chemotherapy          and/or radiation therapy.   "
182595|NCT00231868|"     Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing.     The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for     the treatment of UPSC are yet to be established. A retrospective review of 16 patients     treated at our institution with the sequential use of radiation sandwiched between     paclitaxel/platinum chemotherapy found only one patient to have recurred at 16 months with a     median follow-up of 15 months (range 6-33 months). The regimen was well tolerated. Eight of     the sixteen patients (50%) developed grade 3 neutropenia following cycle 4 of chemotherapy,     two of which required a 1 week treatment delay. There were no cases of grade 3 or 4     thrombocytopenia noted. There was no febrile neutropenia and no hospital admissions for     toxicity. There were no observed grade 3 or 4 non-hematologic toxicities. With the median     follow up of 15 months, we have not observed late toxicities.      Given these favorable preliminary findings, supported by recently published data documenting     efficacy of the sandwich multimodality technique in other difficult uterine malignancies     (malignant mixed mullerian tumors), we propose to study this combination of chemotherapy and     radiation prospectively. Our aim is to better evaluate patterns of recurrence and possible     benefits in progression-free and overall survival.   "
182596|NCT00231881|"     This study aims to characterize the permeability as well as some protein involved in the cell     junction in the oesophageal epithelium in patients with GORD symptoms. In addition these     patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and     oesophageal acid perfusion test. Correlations between the characteristics of the reflux and     the biological results will be calculated.   "
182598|NCT00231907|"     The purpose of this research is to compare the safety and ability to stimulate antibodies     (part of the bodies proteins that fight infections) of two influenza (flu) vaccines given to     children 12 to 35 months old. The two flu vaccines being compared are: trivalent inactivated     influenza virus vaccine (TIV), a killed virus vaccine given as a shot licensed for use in     children 6 months of age or older and live attenuated influenza vaccine (LAIV), a live (but     weakened) virus vaccine licensed for children 5 years old and older given as a nose spray.     The strains of the viruses have been weakened so that they do not cause typical influenza     illness, but may allow the body to develop protection against the flu. LAIV vaccine is not     licensed for children less than five years of age, therefore its use in this study is     investigational. Participation is approximately 7 months in duration.   "
182599|NCT00231920|"     This study proposes to enroll 50 young infants, ages 10 to 22 weeks. Each of the fifty     infants will receive two 0.25mL doses of preservative-free Fluzone®, given a minimum of 28     days apart but no more than 42 days apart. Preservative-free Fluzone® will not be     administered at the same time as other routine vaccines. Approximately 2-3mLs of blood sample     will be obtained prior to the first vaccination, approximately 4 weeks after the second     vaccination and 6 months after the second vaccination for the measurement of immune response.     The primary purpose of this study is twofold: 1.) To determine the safety of administering     two doses of preservative-free Fluzone® to young infants and 2.) To determine the capability     of inducing an immune response of administering two doses of preservative-free Fluzone® to     young infants.   "
182600|NCT00231933|"     This study will compare standard individualized care to person-centered care and     community-integrating care for treating psychosis in adults of Hispanic or African descent.   "
182601|NCT00231946|"     The study is designed to investigate the activity of the hormone drug leuprolide acetate in     stabilizing cognitive function in mild-to-moderate AD patients.   "
182602|NCT00231959|"     This study will evaluate the effectiveness of pramipexole (Mirapex) in managing     treatment-resistant depression.   "
182603|NCT00231972|"     This study will evaluate the effectiveness of a behavioral intervention program versus     standard prevention case management in promoting safer sex practices in HIV-infected men.   "
182604|NCT00231985|"     This study will compare the efficacy of supportive therapy versus habit-reversal therapy for     the treatment of Tourette syndrome and chronic tic disorder.   "
182605|NCT00231998|"     Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent.     In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in     Japanese pediatric patients with atopic dermatitis. This study is a 6-month extension study     following core study.      THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES   "
182606|NCT00232011|"     Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent.     In this study, the long-term safety and efficacy of pimecrolimus cream will be evaluated in     Japanese adult patients with atopic dermatitis. This study is a 6-month extension study     following core study.      THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES   "
182607|NCT00232024|"     This study is being done to evaluate the safety, tolerability and satisfactory relief of     dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will     be evaluated at 6mg twice daily and placebo.   "
182608|NCT00232037|"     This study is being done to evaluate the long-term safety of tegaserod in women with symptoms     of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice     daily.   "
182609|NCT00232050|"     This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult     patients with moderate to severe bronchial asthma.   "
182610|NCT00232063|"     In patients with severe adult atopic dermatitis, the safety and efficacy of OL27-400MEPC will     be assessed by repeating oral administration at a dose of 3 mg/kg/day (2-5 mg/kg/day) in 2     divided doses daily for 8-12 weeks and recovery until 52 weeks after starting treatment   "
182611|NCT00232076|"     To assess the efficacy and safety of oral OL27-400MEPC 3 mg/kg/day (2-5 mg/kg/day) in 2     divided doses daily for 8 weeks to patients with severe adult atopic dermatitis.      THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES   "
182612|NCT00232089|"     This study is being done to evaluate the safety, tolerability and satisfactory relief of     dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will     be evaluated at 6mg twice daily and placebo.   "
182613|NCT00232102|"     This study is being done to evaluate the long-term safety of tegaserod in women with symptoms     of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice     daily.   "
182614|NCT00232115|"     An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%,     in adult patients with perioral dermatitis.      This study is not enrolling patients in the United States.   "
182615|NCT00232128|"     This research trial involves the development of a new treatment for lung tumors. It is for     patients whose tumor cannot be surgically removed, have refused surgery, or the tumor has not     responded well to other forms of treatment. This treatment uses a needle probe to deliver     energy into the lung tumor. This probe is placed utilizing a CT scan image. The energy heats     the tumor causing tumor cell death.   "
182616|NCT00232999|"     This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel     anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic     asthma and the related increased sensitivity of the airways to other substances, as well as     to investigate a possible anti-inflammatory effect of the drug in the airways.   "
182618|NCT00233025|"     To test the hypothesis that the efficacy and safety of duloxetine has beneficial effects of     the reduction of pain severity as measured by the average pain item of the BPI and the PGI-I     in patients with fibromyalgia syndrome.   "
182619|NCT00233038|"     The purpose of the study is to learn about a new treatment for pancreatic cystic lesions. The     injection of alcohol into cysts is a common way of treating cysts of the liver, kidney, and     thyroid. We would like to find out if injection of alcohol would be useful for the treatment     of pancreatic cystic lesions. The treatment with alcohol will use endoscopy and endoscopic     ultrasound (procedures that use a scope that is placed through your mouth and into your     stomach). We hypothesize that more than half of the cysts which are injected with ethanol     will resolve.   "
182620|NCT00233051|"     The purpose of this research study is to determine whether analysis of genes in sputum is a     useful noninvasive technique for measuring response to drugs in patients with COPD.      We propose to use polymerase chain reaction to evaluate gene expression in induced sputum     from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This     study is designed to determine whether changes in expression of previously-identified     inflammatory markers in induced sputum can be detected in response to drug therapy in COPD     and to evaluate potential differences in the expression of these markers in adult smokers     with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic     analysis of therapeutic response as well. Changes in sputum gene expression in response to     treatment will be the primary outcome variable in this study. Secondary outcomes will include     changes in lung function, as well as changes in induced sputum inflammation. These endpoints     will be evaluated before and directly after 6 weeks of randomly-assigned treatment with     either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination     DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.   "
182621|NCT00233064|"     The purpose of this study is to measure the rate of anti-palivizumab antibodies (also     referred to as immune reactivity or immunogenicity) in subjects receiving either the liquid     or lyophilized formulation of palivizumab. This study will compare the number and percentage     of subjects with anti-palivizumab antibodies receiving either the liquid or lyophilized     formulation of palivizumab.   "
182622|NCT00233077|"     The purpose of this study is to determine whether patient-assistance programs as compared     with usual care will help women with early stage breast cancer receive appropriate     treatments.   "
182623|NCT00233090|"     Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.   "
182624|NCT00233103|"     Randomized clinical trial of sertraline vs. placebo for post-TBI depression   "
182625|NCT00233129|"     This is a randomized clinical trial which compares a standard day treatment program for     individuals with TBI with the Executive Plus program; the latter emphasizes training of     attention, emotional self-regulation and problem solving. The goal of the Executive Plus     program is to maximize executive functioning, as well as the long-term outcomes of community     participation and satisfaction with daily life.   "
182626|NCT00233142|"     This study will determine whether the psychological benefits of expressive writing extend to     diabetic patients, how long the benefits will last, and whether additional expressive writing     booster sessions will lead to greater and more sustained improvement in diabetes symptoms     and well-being.   "
182627|NCT00233155|"     The purpose of the study is to evaluate the safety and efficacy of NGX-4010 administered at     intervals of no less than 12 weeks over 1 year, based on the presence or return of pain, for     the treatment of painful HIV-AN and PHN. Participation is limited to former study subjects     from previous trials of NGX-4010 at selected sites.   "
182628|NCT00233168|"     This study will determine the differential cumulative mean number of isoniazid (INH) pills     completed over 9 to 12 months for adolescents assigned to one of the following two groups: 1)     peer adherence coaching, parent training, and self-esteem/life skills counseling; or 2)     self-esteem/life skills counseling alone. The study will also estimate the costs and cost     effectiveness of peer adherence coaching versus control procedures; this will be done from a     provider and societal perspective.   "
182629|NCT00233181|"     To evaluate the effectiveness of a Head Start-based early intervention for designed to     improve asthma management skill and practices of parents, pre-school children and Head Start     staff.   "
182630|NCT00233194|"     The purpose of this research is to study and improve the methods used to detect childhood     breathing problems during sleep that can affect daytime behavior at home and school. Early     diagnosis of these sleep disorders may allow doctors to treat children at a time when the     consequences can still be reversed.   "
182631|NCT00233207|"     This is a phase II, randomized, double-blind, placebo-controlled, safety and efficacy study     of a recombinant chimeric monoclonal antibody against CD14 (IC14) in hospitalized patients     with acute lung injury (ALI).   "
182632|NCT00233220|"     The purpose of this study is to test the effectiveness of a multi-component evidence-based     intervention that targets both patients and physicians, in improving BP control rates in     patients followed in 30 Community/Migrant Health Centers (C/MHCs).   "
182633|NCT00233233|"     This study will examine how the assessment mode influences the validity of self-reported     adherence to asthma therapy. Self-reported adherence to asthma therapy data will be collected     using one of three randomized assessment modes (interview, computer, or telephone).   "
182649|NCT00233441|"     Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose     to be further investigated in the maintenance of sinus rhythm after electrical,     pharmacological or spontaneous conversion of AF/AFL.   "
182650|NCT00233454|"     The safety and efficacy of midostaurin (PKC412), a novel investigational drug, will be     evaluated on the basis of response rate, when administered to patients with aggressive     systemic mastocytosis (ASM) or mast cell leukemia (MCL)   "
182651|NCT00233467|"     The main purpose is to show the percentage of patients taking antipsychotics with PTSD by     looking at approximately ten year’s worth of data from 1994 through 2004. We will also     determine the type and dose of antipsychotics the patients received, and to determine how     many of those patients had psychotic versus nonpsychotic symptoms. We will be obtaining this     data from the VISN 7 Corporate Data Warehouse. We hypothesize that there has been an overall     increase in antipsychotic use in patient’s with PTSD over the last 10 years.   "
182653|NCT00233493|"     The objective is to demonstrate person-to-person spread of dermatophytes of the skin and     nails among family members, as measured by fungal culture and DNA typing of the dermatophytes     isolated.   "
182657|NCT00233545|"     Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent     antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L     braziliensis in Bolivia and cutaneous leishmaniasis due to L panamensis in Colombia. This     trial is intended to evaluate miltefosine for cutaneous leishmaniasis due to L braziliensis     in Bolivia. Patients will be randomly assigned to miltefosine or pentavalent antimony.     Standard dose regimens will be used for both drugs.   "
182634|NCT00233246|"     This study will compare patients with mild to moderate prolongation of the INR test who     receive FFP infusions prior to invasive hepatobiliary procedures for bleeding complications     to patients who do not receive FFP infusions. Bleeding complications will be defined as     meeting one or more of the following:        1. Intrahepatic hematoma greater than 1 ml/kg of patient weight as seen on post-procedure          ultrasound examination performed between 4 to 30 hours after the procedure.        2. Greater than 1.6g/dL hemoglobin decline measured within 4 to 30 hours post-procedure          compared with the pre-procedure value, in the absence of another identified bleeding          source to account for the hemoglobin drop.        3. Need for transfusion of packed red blood cells for procedure-related bleeding while in          the study.      The secondary endpoints of this study will be: 1) The need to perform subsequent procedures     (angiography, embolization, additional imaging study including computerized tomography (CT)     scan, surgery) to diagnose or to arrest procedure-related bleeding OR the need for subsequent     medical therapies (FFP, coagulation factor concentrates, anti-fibrinolytics) to treat     procedure-related bleeding between time of procedure and the end of patient's time in the     study. If necessary, the relationship of procedure or therapy to procedure-related bleeding     will be assessed by an adjudication panel; 2) The predictive value of INR; 3) The effect of     study treatment on change in INR; 4) The cost of preventing one bleed; 5) The predictors of     bleeding other than INR; 6) The number of transfusion-associated adverse events encountered     to prevent one bleed; and 7) The effect of treatment on bleeding grade.   "
182635|NCT00233259|"     The Viva Bien! trial will comprehensively evaluate a multiple risk factor intervention (diet,     physical activity, stress management, social support, and smoking cessation) in a randomized     effectiveness trial, which will be offered in English and Spanish to diabetic Latinas.   "
182636|NCT00233272|"     Background:      - The Baltimore Longitudinal Study of Aging (BLSA) is a clinical research program on human     aging that began in 1958. Volunteers of different ages join the study when they are healthy,     and have follow-up visits for life. Visits last for multiple days. Participants are evaluated     for many physical elements as well as for brain function. Physical tests are given.     Information on mood, personality, and social aspects of life is also collected. This program     has contributed more than any other research project to our understanding of aging.      Objectives:      - To characterize the many aspects of the aging process and learn how people can successfully     adapt to aging.      Eligibility:      - Healthy individuals at least 20 years old.      Design:        -  Participants will receive a booklet and video describing the tests they will take.        -  During a 3-day visit at the study hospital, participants will take the following tests:        -  Urine will be collected for 24 hours. Blood samples will be taken. A small piece of          muscle tissue may be collected by a needle.        -  A medical questionnaire and a physical exam will be given.        -  Participants hearts will be tested, including with blood pressure tests and electronic          monitors. They will breathe into a tube to test their lungs.        -  Participants will perform several exercises, including treadmill walking.        -  Vision, hearing, and taste will be tested.        -  Bone and joint X-rays may be taken.        -  Imaging tests will be given, such as an MRI.        -  Participants will answer questions to test their mental abilities.        -  Participants will return for follow-up visits every few years for life. The tests listed          above will be given at every visit.   "
182637|NCT00233285|"     To investigate gene-environment interactions that may influence susceptibility to respiratory     illness in children living in highly polluted areas in California.   "
182638|NCT00233298|"     The purpose of this study is to find out whether the hormones in the taste buds are affected     by tasting and eating food, and also whether these hormone levels are affected by an increase     in body weight or type 2 diabetes.   "
182639|NCT00233311|"     The purpose of this research study is to determine whether eating a fast food meal (high in     saturated fat) will result in greater increases in inflammatory markers than eating a meal     with low levels of saturated fat and higher levels of mono-unsaturated fat. This study is a     first step in learning about how dietary fat intake can directly impact risk factors for     heart disease, diabetes and obesity.   "
182640|NCT00233324|"     This study compared the use of continuous positive airway pressure initiated at birth with     the early administration of surfactant administered through a tube in the windpipe within 1     hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these     infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor     their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped     determine whether or not these two management strategies affect chronic lung disease and     survival of premature infants.   "
182641|NCT00233337|"     This study will assess the safety and efficacy of co-artemether in the treatment of acute     uncomplicated P. falciparum malaria in returning non-immune travellers      THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES   "
182642|NCT00233350|"     3D ultrasound is a new modality used in image guided neurosurgery. a multicentre study is     started for the evaluation of this tool as a means for achieving total resection of brain     tumors at greater safety.   "
182643|NCT00233363|"     The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide     on dry mouth in patients with Sjögren’s syndrome in comparison with placebo.   "
182644|NCT00233376|"     We developed a computerized decision support system for prescription of antibiotics to     inpatients. The purpose of the study is to assess the performance of the system in different     wards, in three different hospitals, in three countries.   "
182645|NCT00233389|"     To examine the efficacy of continued administration of rebamipide following bacteria     eradication therapy in patients with H. pylori-positive active gastric ulcer in a     placebo-controlled, double-blind study   "
182646|NCT00233402|"     The purpose of this study is to document the additional detection of papillary bladder cancer     and the reduced early recurrence due to the improved detection and resection of these tumors     after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder     cancer.   "
182647|NCT00233415|"     The purpose of the trial is to test the efficacy of combining conventional chemoradiotherapy     with radiosurgery for locally advanced pancreas cancer.   "
182648|NCT00233428|"     The purpose of this study is to see if there is a racial and/or gender difference in platelet     aggregation.   "
182663|NCT00233623|"     The aim of the study is to determine if Iressa added to chemotherapy with Irinotecan,     5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening     (Time to Progression) in patients with metastatic colorectal cancer.   "
182664|NCT00233636|"     The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in     shrinking tumour dimensions.   "
182665|NCT00233649|"     The purpose of this study is to determine in DM II patients the efficacy of Crestor in     obtaining the new European LDL cholesterol guidelines.   "
182666|NCT00233662|"     The purpose of this study is to determine whether repeat courses of alefacept, administered     intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving     standard dermatology treatments.   "
182667|NCT00233675|"     To assess the long-term safety and tolerability of tiagabine treatment in patients with     generalized anxiety disorder (GAD).   "
182668|NCT00233688|"     The objective of this clinical study is to assess the safety and effectiveness of the Cordis     Endovascular Quantum LP™ Stent Graft System.   "
182669|NCT00233701|"     The overall aim of the registry is to develop a longitudinal, observational database that is     focused on adult patients with Normal Pressure Hydrocephalus (NPH) that can be used as a     source of clinical information for individual surgeons, as well as a national data repository     for scientific inquiry and publications.   "
182670|NCT00233714|"     The main objective of this study is to assess safety and effectiveness of double dose     sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary     lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents.   "
182671|NCT00233727|"     The study measures the impact of screen-and-treat on the prevalence of high-grade cervical     intraepithelial neoplasia and cancer (CIN 2+). It is a three-arm, randomized clinical trial     comparing two screen-and-treat approaches to delayed evaluation as a control. The primary     outcome is biopsy-confirmed CIN 2+ at 6 months and significant complications within 6 months     of randomization with continued follow-up to detect CIN2+ and other complications up to 36     months post-randomization.   "
182672|NCT00233740|"     The main objective of this study is to monitor the safety and effectiveness of the OptEase™     Permanent Vena Cava (IVC) Filter   "
182673|NCT00233753|"     Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck,     intracranial, saccular aneurysms arising from a parent vessel   "
182674|NCT00233766|"     The objective of this study is to assess the performance and safety of two reduced sirolimus     doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX)     Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.   "
182675|NCT00233779|"     The objective of this study is to assess the performance and safety of a sirolimus-eluting,     heparin-coated, cobalt chromium balloon-expandable stent (Small Vessel Stent) in patients     with de novo native coronary artery lesions in small vessels as compared to historical data     from small vessel patients in the RAVEL trial receiving the Sirolimus-eluting Bx VELOCITY™     stent.   "
182676|NCT00233792|"     This is a single center, non-randomized study. Patients will be treated with the sirolimus     coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will have     a repeat angiography at four months and will be followed for twelve months post-procedure.   "
182677|NCT00233805|"     The main objective of this study is to assess the safety and effectiveness of the sirolimus     coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native     coronary lesions as compared to the bare metal Bx VELOCITY balloon-expandable stent. Both     stents will be mounted on the Raptor Rapid Exchange Delivery Stent System.   "
182678|NCT00233818|"     The objective of this study is to assess the performance and safety of a formulation of the     antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent     mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de     novo coronary artery lesions.   "
182679|NCT00233831|"     The aim of the study was to test whether the exposure to electromagnetic millimeter waves -     Millimeter Wave Therapy (MWT) is effective for relief of acute postoperative pain in patients     after elective unilateral total knee arthroplasty (TKA)   "
182680|NCT00233844|"     The aim of the trial is to study the possible mechanism of the pain reducing effect of CT at     peripheral venipuncture   "
182681|NCT00233857|"     The aim was to investigate whether auricular acupuncture is superior to sham acupuncture in     relief of acute postoperative pain and in reduction of analgesics consumption on demand and     their side effects in patients after ambulatory knee arthroscopy   "
185082|NCT00268788|"     The purpose of this study is to evaluate the effect of subcutaneous administration of     immunoglobulin compared to intravenous treatment, for multifocal motor neuropathy      NB. ONLY RECRUITING FROM DENMARK   "
182682|NCT00233870|"     The purpose of this survey is to identify any concerns regarding the following efficacy and     safety-related issues in clinical practice with the new drugs Fabrazyme for intravenous     infusion 5mg and Fabrazyme for intravenous infusion 35mg and to confirm the safety of     these products in long-term use in the clinical setting.        1. New adverse drug reactions (ADRs) that cannot be predicted from the Precautions (in          particular, clinically significant ADRs)        2. The incidence of ADRs under the actual conditions of use of the drug        3. Causal factors that might potentially affect safety        4. Efficacy evaluation in long-term use      This survey will be conducted in accordance with the approval condition established for     Fabrazyme:      To conduct a special surveillance of Efficacy and Safety in long term treatment and     Pediatric with the drug.   "
182683|NCT00233883|"     The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free     injection device used to administer Fuzeon, compared with the standard needle/syringe     supplied with commercial Fuzeon. The anticipated time on study treatment is <3 months, and     the target sample size is <100 individuals.   "
182696|NCT00234065|"     The purpose of this study is to investigate the efficacy of cilostazol in preventing     recurrence of cerebral infarction and the safety of long-term administration of the drug (100     mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral     embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg,     once daily).   "
182684|NCT00233896|"     Patients with gastrointestinal graft-vs.-host disease are randomized to oral beclomethasone     dipropionate (BDP) 8 mg/day or identical placebo tablets for 50 days, along with a 10-day     induction course of prednisone. At study day 10, patients whose symptoms of GVHD are under     control undergo a rapid prednisone taper over 7 days, while study drug is continued to study     day 50. After discontinuation of study drug at study day 50, patients are followed for 30     additional days, to study day 80. The primary endpoint is treatment failure by day 50, that     is, a flare of the symptoms of GVHD that requires immunosuppressive therapy. Secondary     endpoints are treatment failure by day 80, treatment-emergent adverse events, and survival at     transplant day 200. The hypothesis to be tested is that a topically-active corticosteroid     (beclomethasone dipropionate, BDP), taken orally, would allow rapid tapering of prednisone     while maintaining control of intestinal GVHD.   "
182685|NCT00233909|"     Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing     or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making     cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO)     is more effective with or without zosuquidar in treating acute myeloid leukemia.   "
182686|NCT00233922|"     Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining     appropriate consent, they are entered into either a control arm where reconstruction of the     orbit is done with a titanium mesh (established practice) or the experimental arm where     reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are     followuped at 1 week, 1 month, 3 months, 6 months & 12 months. CT scan of the orbits are     performed preop, 6 months & 12 months. End point is the 12 month follow-up appointment.     Visual acuity, range of motion, enophthalmos & diplopia are assessed in follow-up.   "
182687|NCT00233935|"     The goal of this clinical research study is to test the safety of defined green tea catechin     extract at different dose levels. Researchers also want to find out what effects, good and     bad, it may have on individual and their risk for esophagus cancer. Esophagus cancer is an     increased risk associated with Barrett's esophagus. Chemoprevention is the use of certain     drugs to keep cancer from forming, growing, or coming back. The use of defined green tea     catechin extract may prevent esophageal cancer.   "
182688|NCT00233948|"     RATIONALE: Antiviral drugs, such as nelfinavir mesylate, may help prevent cancer cells from     spreading.      PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir     mesylate and to see how well it works in treating patients with recurrent, metastatic, or     unresectable liposarcoma.   "
182689|NCT00233961|"     RATIONALE: Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the     bone marrow to the blood so they can be collected and stored until transplant.      PURPOSE: This phase I trial is studying the side effects of G-CSF in stimulating peripheral     stem cells for autologous stem cell transplant in treating patients with chronic phase     chronic myeloid leukemia in remission.   "
182690|NCT00233974|"     RATIONALE: Comparing results of diagnostic procedures, such as molecular marker profiling,     done before and after chemotherapy, may help doctors predict a patient's response to     treatment and help plan the best treatment.      PURPOSE: This phase II trial is studying how well molecular marker profiling of axillary     lymph nodes works in predicting response in patients with locally advanced or metastatic     breast cancer who are undergoing chemotherapy followed by surgery.   "
182691|NCT00233987|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell     transplant may allow more chemotherapy to be given so that more cancer cells are killed.     Tandem (two) autologous stem cell transplants may be an effective treatment for Hodgkin's     lymphoma.      PURPOSE: This phase II trial is studying how well tandem stem cell transplantation works in     treating patients with progressive or recurrent Hodgkin's lymphoma.   "
182692|NCT00234000|"     RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer     cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of azacitidine when     given together with arsenic trioxide and to see how well they work in treating patients with     myelodysplastic syndromes.   "
182693|NCT00234026|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with     newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma.   "
182694|NCT00234039|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving gemcitabine directly into the bladder may kill more tumor cells.      PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with     recurrent bladder cancer that has progressed despite previous Bacillus Calmette-Guerin (BCG).   "
189834|NCT00322764|"     The primary purpose of this study is to determine the safety and efficacy of oral RG2417     (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.   "
182695|NCT00234052|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.     Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium     together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent     non-small cell lung cancer.   "
182697|NCT00234078|"     The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension     in dry eye patients.   "
182699|NCT00234104|"     This drug is being developed to treat cardiac edema. The primary purpose of this study is to     investigate the dose response for body weight in seven-day repeated oral administration of     OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion     secondary to CHF despite taking furosemide at 40 mg/d or more. This study is being conducted     in Japan.   "
182700|NCT00234117|"     The purpose of this study is to determine if 20mg BID of Rabeprazole is effective in     controlling GERD in patients with concomitant bronchial asthma and to assess improvement in     asthma after reflux control.   "
182701|NCT00234130|"     This study will determine whether a new form of home hemodialysis carried out at night during     sleep reduces blood levels of hormone-like substances called cytokines that may cause fatigue     and increase blood fats and sugar. Participants will stay twice in the Rockefeller Hospital     and receive a standard diet and blood testing. Training for nocturnal hemodialysis will be     provided at the nearby Manhattan Dialysis Center of The Rogosin Institute, affiliated with     The Rockefeller University.   "
182702|NCT00234143|"     Myelodysplastic syndromes (MDS) are acquired clonal disorders of the bone marrow. The     clinical consequences of MDS are bone marrow failure and a predisposition to develop acute     myeloid leukaemia (AML). Patients with 'low risk MDS' have less than 10% myeloblasts in the     marrow and include the World Health Organization (WHO) subtypes refractory anaemia (RA),     refractory anaemia with ring sideroblasts (RARS) and refractory anaemia with excess blasts-I     (RAEB-I). This group of patients has a relatively low risk of leukaemic transformation and     the major clinical problem is the manifestation of bone marrow failure. Up to 80% of these     patients become red cell transfusion dependent. To date, the only curative therapy is     allogeneic stem cell transplantation. Unfortunately, a median age at diagnosis of > 65 years     excludes this type of therapy for most patients with MDS. The aim of treatment is, therefore,     supportive therapy. Long term red cell transfusion therapy carries the problems of acute     transfusion reactions: iron overload, alloantibody formation, poor venous access and the risk     of transfusion transmitted infection. With time, such patients require increasing frequency     of transfusion and obtain decreased length of benefit from transfusion. The quality of life     of such patients is significantly reduced. Alternative therapies, therefore, aimed at     promoting more effective haemopoiesis and reducing the need for red cell transfusion may     improve quality of life, reduce the use of expensive resources such as red cells and iron     chelation, and perhaps enhance survival.      Combined darbepoetin alfa (Aranesp) plus G-CSF (Neupogen; filgrastim) in low risk MDS is     better than best supportive care, with respect to haemoglobin and quality of life. The study     will assess:        -  the costs of this approach        -  long-term outcomes        -  clinical/laboratory parameters allowing early cessation of therapy in patients destined          not to respond   "
182703|NCT00234156|"     This study will evaluate how a common dietary sugar (fructose) raises blood fats     (triglycerides). We will determine whether the production of fat from fructose is higher in     dialysis patients compared to healthy volunteers. Dialysis patients have high levels of     hormone-like substances called cytokines that may increase blood fats. The results will help     set better guidelines for diets for the general population and patients with kidney disease     who are at high risk for heart attack and stroke.      There will be one or two outpatient screening visit(s) and a one-week (6 nights) stay at the     Rockefeller University Hospital.   "
182704|NCT00234169|"     Hematopoietic stem cells (HSC) are used to support the administration of high dose     chemotherapy for a range of human cancers. For a safe HSC transplantation, a minimum of 5     million HSC per kilogram are required. HSC are collected from the bone marrow by using drugs     such as G-CSF (filgrastim) which 'mobilize' them from the bone marrow into the bloodstream.     HSC are collected from the bloodstream using an apheresis machine. Between 5 and 60% of     patients fail to mobilize the minimum HSC dose required for safe transplantation, and this     trial is investigating a way to enhance mobilization to overcome this problem. This trial     aims to determine if a new vitamin A derivative is capable of enhancing HSC mobilization when     used in conjunction with G-CSF. Patients will undergo two mobilization procedures. They will     be given G-CSF alone, or a combination of the study drug plus G-CSF, and their stem cells     will be collected. A comparison group of patients will be given G-CSF alone for both     mobilizations. Stem cells collected from patients in this trial will be frozen and stored     until they are required for transplantation into that patient. At that time, patients will be     monitored for how well they recover from their high dose chemotherapy and HSC     transplantation.   "
182718|NCT00234377|"     The purpose of this study is to document the clinical benefit of quetiapine (Seroquel)     sustained release (SR) after switching from another ongoing antipsychotic treatment,     regardless of the reason for the switch.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
182719|NCT00234390|"     The purpose of this study is to investigate the ability of budesonide, given during episodes     of troublesome lung symptoms to reduce further symptoms in infants and young children at risk     of developing asthma   "
182720|NCT00234403|"     The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose     of fulvestrant 250 mg im once a month will be evaluated in female patients with     histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer   "
182705|NCT00234182|"     We conducted a randomized controlled trial of adjuvant interferon therapy in patients with     predominantly hepatitis B-related hepatocellular carcinoma (HCC) to investigate whether the     prognosis after hepatic resection could be improved. Since February 1999, patients with no     residual disease after hepatic resection for HCC were randomly assigned with stratification     by pTNM stage to receive no treatment (control group), interferon alpha-2b 10 MIU/m2 (IFN-I     group) or 30 MIU/m2 (IFN-II group) thrice weekly for 16 weeks. Enrollment to the IFN-II group     was terminated from January 2000 because adverse effects resulted in treatment     discontinuation in the first 6 patients. By June 2002, 40 patients each had been enrolled     into the control group and IFN-I group. The baseline clinical, laboratory and tumor     characteristics of both groups were comparable. The 1- and 5-year survival rates were 85% and     61%, respectively for the control group and 97% and 79%, respectively for the IFN-I group     (P=0.137). After adjusting for the confounding prognostic factors in a Cox model, the     relative risk of death for interferon treatment was 0.42 (95% CI 0.17 - 1.05; P=0.063).     Exploratory subset analysis showed that adjuvant interferon had no survival benefit for pTNM     stage I/II tumor (5-year survival 90% in both groups; P=0.917) but prevented early recurrence     and improved the 5-year survival of patients with stage III/IVA tumor from 24% to 68%     (P=0.038). In conclusion, in a group of patients with predominantly hepatitis B-related HCC,     adjuvant interferon therapy prevented early recurrence and improved survival in those with     pTNM stage III/IVA tumors.   "
182706|NCT00234195|"     -  To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment          of Major Depressive Disorder in women with breast cancer.        -  To evaluate the tolerability of bupropion extended-release (Wellbutrin XL™) in these          patients   "
182707|NCT00234208|"     Multicenter, randomized controlled study to compare early mini-invasive thoracoscopy to     simple chest tube drainage in complicated parapneumonic effusions or pleural empyema. 100     patients will be recruited. Follow-up will be 3 months. It will be looked at the rate medical     cure, the need for secondary interventions, death and duration of hospital stay. In a nested     trial in 20 patients the intrapleural pharmacokinetics of linezolid (approved antibiotic     agent) will be measured.   "
182708|NCT00234221|"     This study will compare three alternative interventions in the emergency department (ED) to     promote substance abuse assessment, referral, and treatment entry: 1) a 5 session     strengths-based case management model (SBCM); 2) a 2-session motivational enhancement therapy     (MET); or 3) a one-time brief informational feedback (BIF) session. The primary outcome     variables for this trial include follow-through on receiving an assessment and referral, and     treatment engagement. Additional outcomes include degree of treatment completion,     alcohol-related measures, health service utilization, health status changes, and psychosocial     factors.   "
182709|NCT00234234|"     Rheumatoid arthritis (RA) is the most common inflammatory rheumatic disease which is     characterized by joint inflammation (clinical involvement), by osteo-cartilaginous lesions     (structural damage) and generally by bone involvement. All those features lead to great     disability. Because it represents a major problem of the public health care system, RA has     been selected as one of the main objectives of the government for the next five years.      RA patients who do not respond to DMARDs require a treatment by TNF-a blocking agents.     However, no information is available to predict the clinical, structural and bone responses     to those new drugs that can be responsible of severe side-effects. Moreover, they are     particularly expensive since their yearly cost is estimated between 75000 and 112500 k euros     for the G4 region.      The purpose of the present research project is to determine potential predictive factors of     the response to a new TNF-a blocker ie adalimumab. To address this question, several     investigations will be performed including measurement of different blood markers,     particularly bone markers, well-defined autoantibodies and new autoantibody populations     identified by proteomic analysis, large-scale analysis of gene expression with cDNA arrays     from blood mononuclear cells, and use of different imaging tools.      The criteria of judgement will be the clinical, structural and bone responses to those new     agents.      This study requires the recruitment of about 100 patients receiving adalimumab for a 1-year     period.      At the end of the study, we hope to identify predictive factors of the response to     adalimumab, which will lead to a better management of this TNF-a blocker. Indeed, they will     be prescribed only for the patients who are likely to respond to those drugs. Thus, this     study should allow to elaborate theranostic algorithms. Such an approach will have great     benefits for the patients: more rapid efficacy, less severe side-reactions and lower costs.   "
182710|NCT00234247|"     The purpose of this study is to look at the long term consequences of prematurity in infants     treated with inhaled nitric oxide (iNO) while in the neonatal intensive care unit.   "
182711|NCT00234260|"     GENOA, the Genetic Epidemiology Network of Arteriopathy, consists of a network of three field     centers and biochemical and genetic core labs to study the common polymorphic genetic     variations to determine individual differences in blood pressure and essential hypertension     in 1,500 sibling pairs in three racial groups. Linkage analyses are performed using an     extensive array of candidate genes and anonymous markers throughout the genome.   "
182712|NCT00234273|"     The principal objective is to assess and analyze the effects of a six month programme in     Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance     among type 2 diabetics.   "
182713|NCT00234286|"     The BEACON trial (Best Practices for End-of-Life Care for Our Nations' Veterans) was a     six-site implementation study to evaluate a multi-component, education-based intervention to     improve the quality of end-of-life care provided in VA Medical Centers.   "
182714|NCT00234299|"     Aspirin affects many physiological processes through its anti-inflammatory actions. Various     cancers, including prostate cancer, appear to utilize inflammatory signals to facilitate     their growth and progression.      We hypothesize that oral aspirin acts directly on prostate epithelial cells to alter     COX-2-related metabolism and inhibit prostate cell growth.   "
182715|NCT00234312|"     The purpose of the study is to evaluate the efficacy and safety of flexible doses of     escitalopram (Lexapro) compared to sertraline (Zoloft) for treatment of Dysthymic Disorder.   "
182716|NCT00234338|"     The purpose of this study is to estimate the local and systemic tolerability of Prevenar in     children ages 2 to 5 years old in usual care settings.   "
182717|NCT00234364|"     In a blinded echocardiographic study we investigate the frequency of valvular abnormalities     in a group of Parkinson patients treated with either ergot derived dopamine agonists     (pergolide and cabergoline) or non-ergot derived dopamine agonists (pramipexole and     ropinirole). The ability to detect patients with valvular abnormalities by clinical approach     is examined.   "
182721|NCT00234416|"     The primary objective of the trial is to identify the dose of gemcitabine given as a 2-hour     intravenous (iv) infusion that can be administered in combination with ZD1839 250 mg once     daily and a standard course (45 Grays [Gy]) of radiotherapy in patients with locally     advanced, unresectable pancreatic cancer.   "
182722|NCT00234429|"     The primary objective of this study is to compare the activity of raltitrexed and ZD1839     versus raltitrexed alone as second line chemotherapy in subjects with colorectal carcinoma by     estimating progression free survival (PFS) in each treatment arm.   "
182723|NCT00234442|"     The aim of the study is to determine if Iressa is effective in the treatment of Brain     metastases from NCSLC   "
182724|NCT00234455|"     The objective of this study is to assess the feasibility and safety of the sirolimus-coated     Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.   "
182725|NCT00234468|"     The aim of the study if to determine if Iressa can prolong the period of time without any     disease worsening (Time to progression) in patients previously treated with combined therapy     such as surgery and chemotherapy with or without radiotherapy or chemotherapy and     radiotherapy   "
182726|NCT00234481|"     The purpose of this study is to assess the safety and tolerability of different doses of     XL844 when given orally to adults with recurrent or refractory chronic lymphocytic leukemia     or small lymphocytic lymphoma.   "
182773|NCT00235092|"     The main objective of this study is to compare the performance of the Cypher     sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective,     multi-center, randomized clinical study.   "
182805|NCT00235521|"     Inhaled nitrous oxide (iNO) will be compared to aerosolized iloprost (ILO) in pediatric     patients after cardiac surgery with pulmonary hypertension. The hypothesis is that iloprost     is more effective in preventing pulmonary hypertensive crises.   "
182806|NCT00229034|"     An observational study to determine the effect of APC and Epo in reducing the systemic     inflammatory response during severe sepsis.   "
182727|NCT00234494|"     Cisplatin is a very important agent for the treatment of TCC as it has a single agent     response rate of approximately 15%. However, it has been most important as a part of     combination chemotherapy, MVAC initially and now in combination with gemcitabine. Single     agent gemcitabine has demonstrated an overall response rate (ORR) of approximately 25%,     including some complete responses (CR), with minimal toxicity in patients with advanced     bladder cancer. Bevacizumab, a murine anti-human VEGF monoclonal antibody, has been advanced     for use in combination with cytotoxic chemotherapy to delay time to disease progression in     patients with metastatic solid tumors.      This trial is designed to further assess the efficacy, safety and tolerability of this     regimen in this patient population.   "
182728|NCT00234507|"     The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo     by assessing functional disability in blepharospasm.   "
182729|NCT00234520|"     The aim of the study is to compare the risk of acromegaly patients developing valvular     regurgitation when receiving lanreotide or octreotide   "
182730|NCT00234533|"     The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq     treated children, using newly developed capillary blood spot IGF-1 measurement technology.   "
182731|NCT00234546|"     The aim of this clinical study is to investigate the efficacy and safety of Dysport® in     patients with early onset of upper limb spasticity within 2-12 weeks after stroke.   "
182732|NCT00234559|"     The purpose of this study is to determine:        1. If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of          angiogenic markers compared to moist wound therapy.        2. If VAC® therapy results in increased angiogenesis compared to moist wound therapy.   "
182733|NCT00234572|"     The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo     after a single injection. Effectiveness and safety were then also assessed following four     fixed-dose injections and after one year of treatment given at titrated doses.   "
182734|NCT00234585|"     This study is designed to demonstrate the safety and efficacy of using a protective     device/drug to prevent renal injury during renal artery stenting and to assess whether the     preventative effects are measurable and if there is a differential treatment effect for     either device alone or in combination.   "
182735|NCT00234598|"     This study tests whether special oral care provided by nurses to critically ill patients who     are on a breathing machine (mechanical ventilator) can help to reduce the build-up of dental     plaque on the teeth and reduce the risk of pneumonia.   "
182736|NCT00234611|"     Currently, the majority of heart failure patients who qualify for and receive a cardiac     resynchronization therapy (CRT) device feel better than before their implant. However, there     are some patients who do not improve after the implant. Michigan Heart is sponsoring a     research study called LOCATE-Pilot to help understand whether the information from an     echocardiogram, performed before implanting the CRT device, improves patients’ responses to     CRT. This is being done by evaluating your heart’s function with an echocardiogram, to     measure your heart’s response during therapy. The study hypothesis is that response to CRT     may be optimized by guiding left ventricular lead placement to the maximally delayed, viable     basal segment of the left ventricle.   "
182737|NCT00234624|"     This 1-year project is intended to study the hemodynamic changes of poratal and hepatic     artery during living related liver transplantation. We hypothesize that after right     hepatectomy for living related liver transplatation, portal vein overflow will change the     remnant liver contour and result in liver hyperplasia.   "
182738|NCT00234637|"     This is a prospective, multicenter, open-label study. Following screening and baseline     assessments, eligible patients will be switched to rivastigmine and will enter the 16 week     run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in     phase, patients who were not sufficiently stabilized on rivastigmine alone will receive     add-on memantine to their rivastigmine treatment; patients who were stabilized on     rivastigmine alone will have completed and be discontinued from the study.   "
182739|NCT00234650|"     The hypothesis to be tested is that position changes during the withdrawal phase of     colonoscopy leads to a higher adenoma (polyp) detection rate because of better distension of     the colon. Since adenomas are precancerous lesions the enhanced adenoma detection will     increase the success of colorectal cancer screening programmes. This study will provide     evidence for the value of position changes and encourage endoscopist to adopt position change     as a routine in their practice.      May 2007: protocol amendment to include additional prospective analysis using High Definition     TV (HDTV).   "
182740|NCT00234663|"     In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation     (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator     (CFTR) protein. PTC124 has been shown to partially restore CFTR production in animals with CF     due to a nonsense mutation. The main purpose of this study is to understand whether PTC124     can safely increase functional CFTR protein in the cells of patients with CF due to a     nonsense mutation.   "
182741|NCT00234676|"     The primary objectives of the POETRY study are to assess the safety and tolerability of     estrogen replacement therapy (ERT) in postmenopausal women with Parkinson's disease (PD) and     to assess recruitment for a study of ERT in postmenopausal women with PD.   "
182743|NCT00234702|"     Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate.     The body's attempt to adjust to an increased level of phosphate in the blood can result in     elevated levels of hormones and minerals resulting in serious clinical consequences. This     study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in     lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared     to placebo.   "
182744|NCT00234715|"     The proposed pilot study is part of the design and development process of a final     questionnaire that aims to gain insight on factors that influences acceptance and adoption of     breast cancer risk assessment in women. Feedback on the questionnaire will help identify     potential issues of clarity, comprehensibility, and reliability; and to identify possible     biases that often accompany a designed questionnaire. Information gained from the large-scale     study will provide directions for the development of educational strategies in the TIBS     research program that could accompany increases in public awareness of risk factors, the     availability of risk assessment tools and preventive lifestyle.   "
182746|NCT00234741|"     STA-5326 is an oral experimental drug that has been shown to block the release of     interleukin-12 from peripheral blood mononuclear cells. Given this activity on the immune     system, STA-5326 mesylate is a potential treatment for various autoimmune diseases, such as     Crohn's disease, that are mediated by the inappropriate expression of Th1 cytokines.      This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe,     active Crohn's disease. Study visits include a screening visit, 4 treatment period visits     over 4 weeks and a follow-up visit that will occur 7 days following the end of treatment.     Subjects may continue treatment for an additional 4 weeks of open label STA-5326 mesylate     administration that includes an additional 2 treatment period visits. Subjects will undergo a     colonoscopy with biopsy collection at baseline, at the end of the 4 week blinded phase and at     the end of the 4 week open label phase.   "
182747|NCT00234754|"     Stress urinary incontinence (SUI) is a health concern for many women. The transvaginal tape     (TVT) surgery has become a common procedure to address the problem. Another surgery is now     available, trans-obturator tape (TOT). The investigators will compare these 2 approaches to     dealing with SUI and follow the women for 1 year. Women will also be followed at 5 years     after surgery.   "
182748|NCT00234767|"     Study of the long term outcomes and economic impact of the pulmonary artery catheter in acute     respiratory distress syndrome (ARDS/ALI) patients.   "
182749|NCT00234780|"     To assess the hypothesis that In Home Hospital Care (IHHC) is as safe and effective, less     burdensome to families, and less expensive for care of common acute pediatric problems now     managed with hospitalization.   "
182750|NCT00234793|"     The purpose of this study is to help mothers of children with cancer to cope more effectively     by increasing their problem-solving skills.   "
182751|NCT00234806|"     This study aims to take the existing model from the pilot of Telemedicine in Daycare and     expand it to other suburban childcare centers and both urban and suburban elementary schools.      An assessment of the value of telehealth in the child programs will then be initiated to     detail the impact of utilization and costs.      An assessment of the value of integrating telehealth into primary care practice will also be     evaluated. The impact of continuity of care, well child visit rates, and immunization status     will be among the various measures used in this evaluation.   "
182752|NCT00234819|"     The purpose of this study is to determine whether bazedoxifene/conjugated estrogens     combinations are effective in the treatment of moderate to severe vasomotor symptoms     associated with menopause.   "
182753|NCT00234832|"     The purpose of the study was to determine the long-term effect of sibutramine treatment on     cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.   "
182754|NCT00234845|"     The purpose of the study is to evaluate the effectiveness of adalimumab in combination with     methotrexate compared to methotrexate alone on work disability in subjects with early     rheumatoid arthritis   "
182755|NCT00234858|"     The primary objective of this study is to determine whether impaired glucose tolerance is     improved to a greater degree by Tarka than Hyzaar in subjects with metabolic syndrome   "
182756|NCT00234871|"     The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is     superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive     subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy   "
182757|NCT00234884|"     The purpose of this observational study was to observe and assess the long term use, safety,     and effectiveness of adalimumab in a normal clinical setting.   "
182758|NCT00234897|"     The purpose of the study is to assess the efficacy of adalimumab in subjects with rheumatoid     arthritis focusing on subject-reported outcomes and early response to treatment   "
182759|NCT00234910|"     The purpose of this study is to obtain a preliminary assessment of the antiviral activity and     tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection,     relative to a Kaletra three drug standard of care reference arm.   "
182760|NCT00234923|"     The purpose of this pilot study is to obtain a preliminary assessment of the antiviral     activity and tolerability of Kaletra single agent therapy as initial treatment for HIV     infection, relative to a Kaletra three drug standard of care reference arm   "
182761|NCT00234936|"     The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate     to improve the quality of life in patients with active RA.   "
182762|NCT00234949|"     The purpose of this study is to compare the efficacy and tolerability of cefdinir to that of     cephalexin in patients with mild to moderate uncomplicated skin/skin structure infections.   "
182763|NCT00234962|"     The purpose of this study is to evaluate the effects of adherence on HIV antiviral response     to treatment regimens containing Kaletra or other HIV protease inhibitors.   "
182764|NCT00234975|"     The purpose of this study is to evaluate clinical response and safety of a Kaletra containing     antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.   "
182765|NCT00234988|"     The purpose of the study is to determine the safety and weight loss when sibutramine is used     in overweight and obese subjects.   "
182768|NCT00235027|"     Patient safety is at the forefront of critical issues in health care. Medications are the     single most frequent cause of adverse events, and in the inpatient setting adverse drug     events (ADEs) are common, expensive, injurious to patients, and often preventable. Relatively     little, however, is known about the frequency of ADEs in the ambulatory setting, how to     monitor for outpatient ADEs, or on the impact of prevention strategies such as     computerization of prescribing supplemented by decision-support.   "
182769|NCT00235040|"     To evaluate the effectiveness of the Acute Respiratory Infection Smart Form   "
182770|NCT00235053|"     This Pilot study is designed to explore the rate of local side effects of fluticasone as     delivered by Advair and to determine the best outcome measure to assess these effects. This     study is the initial step, and will be followed by a larger scale study.   "
182771|NCT00235066|"     The main objective of this study is to assess the effectiveness of the CYPHER™     (sirolimus-eluting) stent in reducing in-lesion late lumen loss in de novo native coronary     artery lesions in small vessels (2.25 - 2.75 mm) as compared to the small vessel tercile of     the uncoated Bx VELOCITYTM Stent patients from the SIRIUS Trial, using a stenting technique     that minimizes balloon trauma to the vessel and assures full coverage of the lesion with the     stent.   "
182774|NCT00235105|"     Reduction of signs and symptoms in patients with moderate to severely early axial     spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to     or do not tolerate NSAID therapy.      Study Objectives:Efficacy –To assess whether patients with moderate to severely active early     axial spondyloarthritis (without radiological sacroiliitis) will show response when     adalimumab is added to the pre-existing or in case of intolerance to NSAID therapy. Response     will be measured at week 12 by change of efficacy parameters compared to baseline.Safety – To     demonstrate the safety of adalimumab in study patients with moderate to severely active early     axial spondyloarthritis (without radiological sacroiliitis) in patients who have had an     inadequate response to or do not tolerate NSAID therapy.   "
182775|NCT00235118|"     The objective of this study is to assess the safety and effectiveness of the Cordis Bilateral     AAA device and its Delivery System compared to open surgical repair for the treatment of     Abdominal Aortic Aneurysm (AAA).   "
182776|NCT00235131|"     This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent     System for the treatment of TASC C & D superficial femoral artery long lesions (up to 22 cm)     in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency     rate at 6 and 12 months post procedure.   "
182777|NCT00235144|"     The main objective of this study is to assess the safety and effectiveness of the     sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native     coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent.     Both stents are mounted on the Raptor® Rapid Exchange Stent Delivery System.   "
182778|NCT00235157|"     The primary objective of this study is to compare the safety and performance of the Palmaz     Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of     renal artery stenosis, measured at 6 months follow up via angiography.   "
182779|NCT00235170|"     The main objective is to compare the effectiveness of coronary stent implantation using the     sirolimus-eluting Bx VELOCITY™ balloon expandable stent with that of surgery as observed in     ARTS I. Effectiveness is measured in terms of Major Cardiac and Cerebrovascular Events     (MACCE) free survival at 1 year.   "
182780|NCT00235183|"     The aim of the study is to compare the clinical efficacy of three types of plasma secured on     the viral level either by quarantine or by chemical treatment in patients undergoing liver     transplantation.   "
182781|NCT00235196|"     This is a randomized (1:1), prospective, open label, multicenter, comparative study to be     examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on     diabetic foot ulcers.   "
182782|NCT00235209|"     This is a randomized (1:1), prospective, open label, multicenter, comparative study to be     examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on     venous leg ulcers.   "
182783|NCT00235222|"     Lipodystrophie, peripheral neuropathy and mitochondrial toxicity has been associated to     stavudine at standard doses The aim of this study is to evaluate the efficacy of reduced     doses of stavudine (30 mg b.i.d.) in HIV patients with controlled viral load and body weight     > 60 kg, receiving an antiretroviral therapy containing stavudine 40 mg b.i.d.   "
182784|NCT00235235|"     The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and     pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for     advanced breast cancer. To date no other trial has analyzed gene and protein expression at     the same time points in the same patient, combined with clinical outcome. Similar to previous     attempts to predict response based on expression of a single gene or protein, the researchers     expect that neither genomic or proteomic profiling alone will be sufficient to optimize     therapy. Rather, the researchers expect an iterative process that combines information     gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.   "
182785|NCT00235248|"     The ARCH is a controlled trial with a sequential design and with a prospective, randomized,     open-label, blinded-endpoint (PROBE) methodology. The objective is to compare the efficacy     and tolerance (net benefit) of two antithrombotic strategies in patients with     atherothrombosis of the aortic arch and a recent (less than 6 months) cerebral or peripheral     embolic event.      Hypothesis:      The association of clopidogrel 75 mg/d plus aspirin 75 mg/d is 25% more effective than an     oral anticoagulant (target International Normalized Ratio [INR] 2 to 3) in preventing brain     infarction, brain hemorrhage, myocardial infarction, peripheral embolism, and vascular death.   "
182848|NCT00235885|"     The purpose of the study is to assess the safety and clinical efficacy of adalimumab in     active psoriatic arthritis (PsA) subjects when adalimumab is added to insufficient standard     therapy including patients that have failed other TNF therapies   "
182786|NCT00235261|"     Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e.     morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness,     which is unpleasant for the patients and sometimes keeps them at bed longer time than needed.     We investigate in new combinations of analgesics for postoperative pain, hoping to minimize     the need for morphine and improve the patients pain score after operation.   "
182787|NCT00235274|"     The overarching purpose of the proposed study is to determine Secretin's (RG1068)     psychophysiological effects on measures of motor learning, affective, and inhibitory     information processing in individuals with schizophrenia. Motor learning will be assessed     with a classical eye-blink conditioning procedure, requiring the learning of a reflexive     eye-blink response to a weak puff of air to the eye.   "
182788|NCT00235287|"     The purpose of this study is to determine whether a combination therapy with     angiotensin-converting enzyme (ACE)-inhibitors and angiotensin receptor blockers reduces the     arterial stiffness assessed by applantiontonometry more than a single treatment in kidney     patients.   "
182803|NCT00235495|"     The goal of the trial is to determine whether human albumin, administered within 5 hours of     symptom onset, improves the 3-month outcome of subjects with acute ischemic stroke.   "
182804|NCT00235508|"     To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of     insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will     receive an approved anxiolytic agent and will be randomized to nightly therapy with either     eszopiclone or placebo.   "
182789|NCT00235300|"     A multicenter clinical study comparing event-free survival at 6 months after transplant     between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients     received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of     the transplant procedure.      Subjects meeting all inclusion and exclusion criteria were eligible to participate in this     study. The treatment assignment was random and not chosen by the subject or their physician.      Subjects were monitored during treatment with Thymoglobulin and during the transplant     hospitalization. Additional subject monitoring occurred up to 12 months after transplant.      278 study subjects were enrolled at 28 transplant centers in the United States and Europe.   "
182790|NCT00235313|"     Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However,     their effectiveness is low. This study aims to answer the question: Does the dose adjustment     of NRT according the saliva concentration of nicotine's main metabolite: cotinine improve     their efficacy compared with the lack of dose adjustment (usual care) in smoking patients     with smoking related disease condition.   "
182791|NCT00235326|"     Acute Bacterial dysentery leads to chronic symptoms of disturbed bowel habit in a minority of     individuals. This condition known as post infectious irritable bowel syndrome (PI-IBS)     remains poorly understood. This could allow material in the bowel to reach deeper tissues of     the bowel wall leading to inflammation and changes in muscle and nerve function. This is also     early evidence that genetic programming of people with PI-IBS prevents them from turning off     inflammation once it begins. Literature suggests that IBS may develop at greater rates in     individuals with pro-inflammatory genotype and that these individuals may be at increased     risk of inflammatory bowel diseases (IBD).   "
182792|NCT00235339|"     The purpose of this study is to investigate the effect of the standard rehabilitation offered     by three hospital rehabilitation units in Norway, one in Trondheim, one in Ålesund and one in     Levanger, compared to an interval treadmill training program. The subjects participating in     the study are patients with myocardial infarction. The maximal oxygen consumption of the     subjects will be tested before and after the training period.   "
182793|NCT00235352|"     The purpose of this study is to evaluate the effects of a four-week trial of CX516 900mg tid     compared to placebo upon verbal memory, attention and negative symptoms. The AMPA receptor     positive modulator, CX516, will be added to a stable dose of clozapine, olanzapine or     risperidone in inpatients and outpatients with schizophrenia. The trial is intended to extend     and replicate results from our previous placebo-controlled pilot trial of CX516 added to     clozapine in which the investigators found improvement in memory and attention     (moderate-to-large between group effect sizes) and did not observe serious side effects.     Because the investigators' pilot trial also detected at two-week follow-up persistence of     cognitive benefits and emergence of a large therapeutic effect upon negative symptoms, this     trial will also repeat clinical and cognitive assessments at follow-up, four weeks after     completion of the study medication to evaluate persistence and/or strengthening of effects.   "
182794|NCT00235365|"     The purpose of this study is to determine the effect of meta-cognitive therapy for insomnia.   "
182795|NCT00235378|"     The purpose of this study is to perform genetic testing in and to collect information from     families affected by lupus in order to identify the genetic factors associated with systemic     lupus erythematosus (SLE).   "
182796|NCT00235391|"     This is an open-label, non-randomized, multi-center trial designed to provide expanded access     of deferasirox to patients with congenital disorders of red blood cells and chronic iron     overload from blood transfusions who cannot adequately be treated with locally approved iron     chelators.   "
182797|NCT00235404|"     To study the efficacy of multicomponent treatment and care for patients with acute illness or     deterioration of a chronic disease at a nursing home in primary health care compared to     traditional treatment at hospital.   "
182798|NCT00235417|"     The purpose of this study is to determine whether intracoronary bone marrow transplantation     can improve left ventricular ejection fraction in patients with severe ischemic heart failure     and no other option for standard therapies (revascularization and drugs).   "
182799|NCT00235443|"     Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with     lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and     tolerability of the different doses of lacosamide will be investigated.   "
182800|NCT00235456|"     Supplemental perioperative oxygen has been reported to halve or double the risk of surgical     wound infection. We tested the hypothesis that supplemental oxygen reduces infection risk     following colorectal surgery. Colorectal surgery patients (n=300) were randomly assigned to     30% or 80% FiO2 intraoperatively and 6 hours postoperatively. Wound infections were diagnosed     by blinded investigators using Centers for Disease Control criteria. Baseline patient     characteristics, anesthetic management, and potential confounding factors were recorded.     Wound infection rates were compared with chi-square analysis. Logistic regression identified     the contribution of potential confounding factors. Surgical wound infection occurred in 24.4%     of patients receiving 30% oxygen, but only 14.9% of those receiving 80% oxygen (P<0.039).     According to logistic regression, the relative risk of infection in patients given     supplemental oxygen was 0.46 (P=0.035). Supplemental inspired oxygen reduced wound infection     risk by roughly a factor of two. We thus recommend that supplemental oxygen be provided to     patients undergoing colorectal surgery.   "
182801|NCT00235469|"     This phase 2b trial is being conducted at approximately 60 sites in the US to investigate     whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic     neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of     lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic     neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity     of ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to start of     treatment.      To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a     diary to record their daily pain intensity (morning and evening), pain interference with     sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and     subjects' quality of life will be investigated. In addition, safety and tolerability of the     different doses of lacosamide will be investigated.   "
182802|NCT00235482|"     The purpose of this study is to determine the safety of an injection of coxsackievirus A21     into a melanoma tumour, and also to see if there is a tumour response.   "
182807|NCT00229047|"     We, the researchers at Lawson Health Research Institute, propose to investigate the impact of     surgical ischemia and reperfusion on skeletal muscle microcirculation using a hand-held     microscope.   "
182808|NCT00229060|"     The purpose of this study is to compare the clinical response rate of doripenem versus a     comparator in the treatment of hospitalized patients with complicated intra-abdominal     infections.   "
182809|NCT00229073|"     The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal     ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).   "
182810|NCT00229086|"     Evaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux     Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo     2000-04   "
182811|NCT00229099|"     The purpose of the study is to establish the equivalence of GerEpo with the standard     treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect     to hemoglobin response and to establish the longer-term safety profile of GerEpo, with     special regards for the occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity     related adverse event   "
182812|NCT00229112|"     This study will compare the efficacy, safety and tolerability of intravenous ertapenem versus     another intravenous antibiotic in the treatment of moderate to severe diabetic foot     infections.   "
182813|NCT00229125|"     The purpose of this study was to evaluate if the medication Gabapentin, which is not approved     for the treatment of alcohol withdrawal, is effective in the treatment of alcohol withdrawal     syndrome compared to treatment with Lorazepam.   "
182814|NCT00229138|"     This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus     at both reference and reduced levels. This study will take into account safety aspects such     as decreased renal toxicity by reducing the overall exposure to tacrolimus.   "
182815|NCT00229151|"     The purpose of this study is to determine if sleep deprivation and sleep phase advancement is     effective treatment of bipolar patients in a depressive phase.   "
182816|NCT00229164|"     The purpose of this study is to investigate the effect of high frequency TENS and compare to     the placebo effect by sham TENS in a randomized control study.   "
182817|NCT00229177|"     The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to     placebo in patients with acute ischemic stroke.   "
182818|NCT00229190|"     Nasal lavage could be an integral component of assessing airway inflammation. Research into     the reproducibility of cell counts is key to understanding the value of lavage results.      The objective of this study is to evaluate and compare the reproducibility of a common nasal     lavage technique and its variation in a sample of subjects with nasal symptoms (e.g. runny     nose, congestion, sneezing, post nasal drip), and in individuals without nasal symptoms.   "
182819|NCT00229203|"     This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2,     given as a 3 hours intravenous infusion every 2 weeks, in patients with relapsed or     refractory multiple myeloma (MM).   "
182820|NCT00229216|"     The purpose of this study is to confirm the safety and efficacy of oral tinidazole for the     treatment of bacterial vaginosis.   "
182821|NCT00229229|"     Type 2 diabetes can be prevented by lifestyle changes in high-risk subjects. However,     controversies exist on nutritional management of diabetes. Recent data suggests that glucose     and insulin responses are affected by not only the quality, but the quantity of carbohydrate     consumed. This is referred to as glycemic load.      To date, there have not been any prospective randomized studies which examine the utility of     a low glycemic load diet.      The purpose of the proposed study is to compare the effectiveness of a Canada Food Guide Diet     with a low glycemic load diet on blood sugar control in overweight type 2 diabetics.   "
182822|NCT00229242|"     MAIN: The benefits of treating high blood pressure successfully to normal levels on heart     function are the same regardless of which particular combination of drugs are used.     SECONDARY: Measurement of heart function using a comprehensive ultrasound imaging method     (Echocardiography) and an objective test of functional ability are better predictors of     changes in heart function with successful hypertension treatment, than subjective signs of     heart failure.   "
182849|NCT00235898|"     The objective of this trial is to compare efficacy and safety of CoFactor and 5-fluorouracil     (5-FU) versus leucovorin and 5-FU in treatment of metastatic colorectal cancer.   "
182823|NCT00229255|"     The purpose of this study is to test the relationship between frequency of meals and hepatic     fat content and insulin sensitivity. We, the researchers at Rockefeller University,     hypothesize that low plasma insulin levels (as achieved by periods of fasting) will prevent     insulin resistance and reduce hepatic lipid content. In contrast, frequent, carbohydrate-rich     meals will predispose to hepatic steatosis (non-alcoholic) and insulin resistance.      This is a 6 week inpatient study.   "
182824|NCT00235534|"     This is a randomized, controlled trial investigating whether immediate versus standard,     Sunday Start, initiation of oral contraceptive pills (OCPs) in post-abortion subjects can     improve compliance and the continuation of contraception. Immediate initiation of OCPs has     been studied in women seeking contraception when they are not immediately post-abortion, and     this Quick Start method has been shown to improve the continuation of OCPs into a second     pill pack. The primary hypothesis of this study is that immediate initiation of OCPs in     post-abortal women will improve the continuation of contraception over delayed initiation on     the first Sunday after an abortion.   "
182825|NCT00235547|"     This is a randomized, controlled trial investigating whether immediate versus standard,     Sunday Start, initiation of transdermal hormonal contraception (the patch) in post-abortion     subjects can improve compliance and the continuation of contraception. Immediate initiation     of the patch has been studied in women seeking contraception when they are not immediately     post-abortion, and this Quick Start method has been shown to improve the continuation of     the patch into a second month. The primary hypothesis of this study is that immediate     initiation of the patch in post-abortal women will improve the continuation of contraception     over delayed initiation on the first Sunday after an abortion.   "
182826|NCT00235560|"     These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in     combination with low-dose aracytin in elderly AML.   "
182827|NCT00235573|"     Vitamin B12 is an essential nutrient that the body needs for cells to divide and function     normally. Individuals may develop a deficiency of vitamin B12 by either limiting the amount     in the diet or by decreased vitamin B12 intake into the body (absorption). Keeping adequate     B12 blood levels is important for health. Vitamin B12 deficiency may increase one's risk for     developing anemia and can even lead to neurological problems and paralysis if the deficiency     is severe and lasts a long time. It is very important for doctors to have accurate tests to     determine if people are absorbing vitamin B12 normally so that treatment can be started     before severe clinical problems occur.      The purpose of this research is to provide new information that may help scientists develop a     better method to test for problems with absorbing vitamin B12. In this study, changes in the     amounts of vitamin B12 bound to protein (transcobalamin) in the blood will be measured after     doses of vitamin B12 are taken. If the amounts of this vitamin B12-protein complex (called     holo-transcobalamin) change in response to taking a vitamin B12 supplement in normal     individuals, it may be possible to use this information to develop a new sensitive test to     identify individuals who have problems absorbing vitamin B12. This new vitamin B12 absorption     test may be a better clinical test for vitamin B12 absorption than those now available for     doctors to use.   "
182828|NCT00235586|"     To learn if there is a connection between low vitamin D level and hardening of the arteries.   "
182829|NCT00235599|"     This project is designed to answer the question: Is there an acute IGFBP-3 response in normal     children?      Our specific hypothesis states that under the influence of growth hormone secretagogues,     intact IGFBP-3 molecule will undergo proteolysis and liberate IGFBP-3 fragments, along with     other components of the ternary complex. This proteolysis will result in measurable rise in     IGFBP-3, which will indicate the subject’s growth hormone status. Short children with growth     hormone deficiency will not show an IGFBP-3 response.   "
182830|NCT00235625|"     Turmeric (Curcuma Longa) is member of the ginger family and is best known for its culinary     use as the major of component of curry powder. The volatile of oils (called curcuminoids) of     the turmeric root, however, have anti-inflammatory actions which make them promising     candidates for the treatment of psoriasis. For example, curcumin has been shown to improve     psoriasis in experiments using in vitro models. Turmeric has been shown to have minimal side     effects in doses up to 12 grams per day. The purpose of this study is to determine the safety     and to estimate the efficacy of oral Curcuminoid C3 Complex® in patients with chronic     psoriasis vulgaris.   "
182831|NCT00235651|"     The purpose of this study is to quantify the dose of aerosol medication deposited in the     lungs of lung transplant recipients receiving a single nebulized treatment of aerosolized     Abelcet® (lipid complexed amphotericin-B). This study is being performed to determine the     range of deposited doses and patterns of distribution that could be expected in this     population so that the ultimate efficacy of this preparation can be evaluated. A radioisotope     technique will be utilized to track the medication dose. The study will include 12 subjects     who will perform one testing session lasting approximately 3 hours. An Investigational New     Drug Application (IND) detailing this protocol has been submitted by the principal     investigator (PI) and approved by the Food and Drug Administration [FDA] (72,521).   "
182832|NCT00235664|"     Infections caused by multidrug resistant bacteria have become more prevalent at many tertiary     care and academic centers. These infections are associated with increased morbidity and     mortality. The initial empiric antibiotic choice may not be adequate and delay in initiating     appropriate therapy is a reason for poorer outcomes. Furthermore, not uncommonly the only     therapeutic options available are associated with significant toxicity. This is a particular     challenge for solid organ transplant recipients, who are immunosuppressed and have a higher     risk of acquiring infections. Exposure to different classes of antibiotics has been linked to     development of antibiotic resistance. Determining the risk factors for acquisition of     drug-resistant bacteria and the molecular mechanisms by which resistance occurs would allow     the development and implementation of strategies to minimize these infections and therefore     improve outcomes. We, the researchers at the University of Pittsburgh, aim to collect     surveillance cultures on patients undergoing liver, intestinal and multivisceral     transplantation in order to determine the prevalence and risk factors for Pseudomonas     aeruginosa (P. aeruginosa), extended-spectrum β-lactamases (ESBL)-Klebsiella and     methicillin-resistant Staphylococcus aureus (MRSA), as well as determine the molecular     mechanisms associated with the development of resistance in P. aeruginosa.   "
182833|NCT00235677|"     Aim:      To evaluate the therapeutic efficacy of a therapeutic procedure, involving endoscopic     suturing, for gastroesophageal reflux disease (GERD) compared to a sham procedure.      The hypotheses tested in this study were that active treatment would: 1) decrease the use of     antisecretory medication, 2) decrease GERD symptoms, 3) improve quality of life, and 4)     reduce esophageal acid exposure.   "
182834|NCT00235690|"     More than 80 patients at the University of Pittsburgh Medical Center have been infected with     Pseudomonas aeruginosa, lacking susceptibility to all commercially available antibiotics     except colistin. This antibiotic was developed in the 1960s and preliminary pharmacokinetic     studies were performed at that time. Dosing recommendations, on the basis of these     pharmacokinetic studies, are listed in the drug's product information. However, there are no     dosing recommendations for patients requiring renal replacement therapy (either intermittent     hemodialysis or continuous venovenous hemofiltration). Furthermore, the science of antibiotic     dosing (pharmacodynamics) has changed significantly since the 1960s and it is quite     possible that the dosing recommendations listed in the product information are not optimal.     Furthermore, even though physicians refer to colistin administration, the only intravenous     form of the drug is colistin methanesulfonate (CMS). CMS is converted in the body to     colistin. Both CMS and colistin have different pharmacokinetic and antimicrobial activities.     For this reason, we, the investigators at the University of Pittsburgh, are performing a     pilot study of the pharmacokinetics of intravenous CMS/colistin in patients requiring this     antibiotic for clinical purposes. Plasma concentrations will be determined around a     CMS/colistin dose once the drug has reached steady state. Concentrations in pulmonary     epithelial lining fluid will also be determined in patients with pneumonia. Microbiologic and     clinical endpoints will be determined and will be correlated with these concentrations. The     measurement of CMS and colistin levels will be determined by a laboratory in Australia which     developed these assays. A submission is being made to the National Institutes of Health (NIH)     for funding of a multicenter study which will address this research question with a greater     sample size. The study proposed here is a pilot study in order to prove the feasibility of     the research approach and to provide preliminary data for the NIH proposal.   "
182855|NCT00236067|"     The purpose of this study is to evaluate the safety and efficacy of an investigational     anti-anxiety medication relative to placebo in patients with generalized anxiety disorder     (GAD).   "
182856|NCT00236080|"     The purpose of the study is to compare the overnight efficacy and plasma concentration-time     profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive     sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).   "
182835|NCT00235703|"     This is a four-year study, funded by the Center for Disease Control and Prevention, related     to antimicrobial resistance in rural communities. The project consists of four components: A)     surveillance of antimicrobial resistance, B) promotion of appropriate antimicrobial drug     prescribing, C) preliminary assessment of the environmental impact of antimicrobials, and D)     the development of new antimicrobial products. Six rural communities in Utah, and six rural     communities in Idaho are participating in this study. Component D is being performed by     investigators at Harvard University, under the direction of Co-Investigator Roger Inouye.   "
182836|NCT00235716|"     The purpose of this study is to determine whether alpha-tocopherol, memantine (Namenda), or     the combination will significantly delay clinical progression in mild to moderately demented     patients with Alzheimer's disease compared to placebo.   "
182837|NCT00235729|"     The main objective of this study is to investigate the effectiveness of lofexidine in     reducing withdrawal symptoms among subjects undergoing opiate detoxification. Currently,     lofexidine is the most commonly used non-opiate medication for detoxification from opiates in     the United Kingdom (UK). There is no non-opiate medication approved by the Food and Drug     Administration (FDA) for the same indication in the United States (US). The only medications     currently approved by the FDA for opiate detoxification are methadone and buprenorphine.     These medications, however, have the potential to be abused. Lofexidine, on the other hand,     offers a unique advantage for opiate detoxification because it is not addicting, is easy to     use, and has a favorable safety profile.   "
182838|NCT00235755|"     This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed     at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in     patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).   "
182839|NCT00235768|"     The purpose of this study is to investigate the possible neurotoxic effects of the party-drug     Ecstasy (MDMA)on brain and brain function in humans. Main research questions concern the     causality, course and clinical relevance of the neurotoxicity of ecstasy   "
182840|NCT00235781|"     The aim of this trial is to compare the safety and efficacy of a single dose of     Thymoglobulin, rabbit derived antithymocyte globulin (Thymoglobulin, SangStat, Fremont, CA)     to our standard four dose, four day Thymoglobulin induction regimen from the time of     transplantation through a six month follow-up period. The primary endpoint will be the     incidence of acute rejection. Secondary endpoints will include serious adverse events,     evaluation of renal function, patient and graft survival, incidence of infectious     complications, incidence of post-transplantation lymphoproliferative disorder (PTLD),     duration and extent of lymphocyte depletion and immunoassays for evidence of recipient immune     response to the allograft as well as duration of hospital stay.   "
182841|NCT00235794|"     Open-label exloratory pharmacodynamic and pharmacogenomic study to evaluate teh biologic     effects of 3 dose levels (1mg, 5 mg, and 15 mg) of temsirolimus administered orally once     daily for approximately 4 weeks (+/- 2 weeks) before prostatectomy   "
182842|NCT00235807|"     The purpose of this multi-site randomized clinical study was to assess treatment outcomes for     three forms of tinnitus treatment: Tinnitus Retraining Therapy (TRT), Tinnitus Masking, and     Tinnitus Education (TED). There were four study sites: VAMC Audiology Clinics at Bay Pines,     FL; Portland, OR; Seattle, WA; and San Diego, CA. Thirty-six subjects (Veterans) were     enrolled into treatment at each site - 12 into each treatment group. Each subject received 18     months of treatment. Treatment appointments and outcome questionnaires occurred at 0, 3, 6,     12, and 18 months. Qualified subjects were initially randomized to one of the treatment     groups or to a 6-month Waiting List group. Those in the Waiting List group completed outcome     questionnaires at 3 and 6 months, and were randomized into one of the three treatment groups.     They then received 18 months of treatment as above.   "
182843|NCT00235820|"     Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and     Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis   "
182844|NCT00235833|"     The purpose of the study is to assess the long-term safety, tolerability, and efficacy of     repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.   "
182845|NCT00235846|"     Conventional open vein harvesting from the legs during coronary artery bypass surgery result     in wound complications among 30% of the patients. Endoscopic harvesting decrease the     complication rate, but it remains to be shown whether this is also a fact among patient in     whom only short segments of veingraft material is needed from the leg. We hypothesise that     the rate of wound complications will be reduced and the patient satisfaction will be     increased also among patients in whom only short vein segments are endoscopically harvested     compared to conventional open vein harvesting.   "
182846|NCT00235859|"     The purpose of the study is to assess the safety and efficacy of adalimumab compared to     placebo in subjects with rheumatoid arthritis on methotrexate therapy.   "
182850|NCT00236002|"     Multi-center,double blind randomized phase III placebo controlled study in 250 men with     histologically proven prostate cancer with out bone metastases who are beginning ADT therapy     and who will receive concomitant treatment with either oral Fosamax 70mg once weekly or     placebo for one year.These men will be treated and follow up for one year,during which time     changes in BMD, markers of bone resorption and formation will be monitored.All patients will     receive calcium and vitamin D through out the study.   "
182851|NCT00236015|"     The purpose of this study is to evaluate the safety and efficacy of an investigational     anti-anxiety medication relative to placebo in patients with generalized anxiety disorder     (GAD).   "
182852|NCT00236028|"     The purpose of this study is to evaluate the efficacy and safety of infliximab (Remicade) in     patients with early rheumatoid arthritis.   "
182853|NCT00236041|"     The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the     management of breakthrough pain (BTP) compared to placebo treatment in children with cancer     and non-cancer pain who are receiving around-the-clock (ATC) opioid therapy and who require     additional therapy for BTP episodes. This will be determined by the analysis of the pain     intensity (PI), measured by the Faces Pain Scale-Revised (FPS-R) administered 15 minutes     after the start of each unit of study drug with an optimal ACTIQ dosage.   "
182854|NCT00236054|"     The purpose of this study is to evaluate the safety and efficacy of an investigational     anti-anxiety medication relative to placebo in patients with generalized anxiety disorder     (GAD)   "
182857|NCT00236093|"     The objective of the study is to monitor the safety (adverse event data) of longer-term use     of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) treatment in children with pain     associated with cancer, sickle cell disease, or severe burns and breakthrough pain (BTP) who     are receiving around the clock (ATC) opioid therapy.   "
182858|NCT00236106|"     Main objective:to assess short term growth in children with atopic dermatitis during     treatment with tacrolimus 0.1% and mometasone furoate 0.1%. A singl blind randomised cross     over trial including 20 children. The study consists of 5 periods: run in, treatment(1),wash     out, treatment(2) and run out. Each period 14 days where the children will use tacrolimus     ointment tvice daily, mometasone furoate once daily or moisturizer (in run in wash out and     run out)   "
182859|NCT00236119|"     A 12-Week, Exploratory, Open-Label, Nonrandomized, Dose-Escalation Study of the Efficacy,     Safety and Tolerability of Oral CEP-701 in Patients with Severe, Recalcitrant, Plaque Type     Psoriasis.   "
182860|NCT00236132|"     The main goal of the pectus multicenter outcomes study is to document the utility of PEx     repair in improving health and quality of life and to test the prevailing belief that the two     predominant surgical procedures currently in use for PEx repair are essentially equivalent in     terms of long-term outcomes.      We believe the uncertainty about the impact of PEx on cardiopulmonary function is due to part     to the fact that the previous studies have not measured the physiological parameters mostly     likely affected by the defect. A protocol to test this was developed. Thus, we propose to use     these measures as well as conventional output of progressive exercise test to examine     cardiopulmonary function before and after surgical repair of PEx within the context of the     original study.   "
182861|NCT00236145|"     The primary objective of the study is to determine whether a test titration regimen of ACTIQ     treatment will reduce the number of inadequately managed episodes of breakthrough pain for an     individual patient by attaining a successful dose of ACTIQ treatment more quickly. The     successful ACTIQ dose provides a satisfactory combination of efficacy and tolerability after     a single administration, as assessed by the patient.   "
182862|NCT00236158|"     Hypothesis Treatment with rate adaptive single chamber atrial pacing (AAIR) reduces the risk     of death compared with rate adaptive dual chamber pacing (DDDR) in patients with sick sinus     syndrome (SSS).      Primary purpose The primary purpose of this randomised trial is to compare AAIR and DDDR     pacing in patients with SSS and normal atrioventricular (AV) conduction with respect to the     primary end point overall mortality.   "
182863|NCT00236171|"     The purpose of this study is to evaluate the efficacy of the topical therapies Protopic and     Advantan as well as their combination against placebo in a Psoriasis Plaque Test   "
182864|NCT00236184|"     The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10     mg in treating frequent heartburn.   "
182865|NCT00236197|"     The purpose of this study is to investigate the safety and efficacy of rabeprazole 10 mg in     treating frequent heartburn.   "
182866|NCT00236210|"     VIP is a demonstration project with a goal to decrease modifiable risk factors for those with     a higher risk of having a vascular event such as a heart attack or stroke or of developing     vascular disease. Introduced as a study, VIP compares whether there is a significant     reduction of modifiable vascular risk factors among patients who are involved in a     personalized directed program versus those being provided standard care by their physician.     Health care providers work collaboratively with the 'VIP Team' to improve the participants'     vascular health.   "
182867|NCT00236223|"     Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e.     morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These     side-effects are unpleasant for the patients and sometimes keeps them at bed longer time than     needed. We investigate in new combinations of analgesics for postoperative pain, hoping to     minimize the need for morphine.   "
182868|NCT00236236|"     The Registry will evaluate how HRV Monitor diagnostics change after cardiac resynchronization     therapy in patients with heart failure.   "
182869|NCT00236249|"     The purpose of this study is to check if lidocaine intravenous administration during surgery     and 24 hours after surgery, associated with standardised management of the patient, helps to     accelerate recovery and to improve the quality of recovery, after surgery for colic or rectal     neoplasms.   "
182870|NCT00236262|"     The objective of this study is to analyze by trans-oesophageal echocardiography the effect on     the right ventricle of positive expiratory pressure (PEP) level variations with constant     plate pressure among patients with syndrome of acute respiratory distress of the adult     (SDRA). The assumption tested is that a high level of PEP increases the impedance with the     ejection of the right ventricle independently of the level of plate pressure. The effect on     the right ventricular preload will be checked via the analysis of the respiratory variability     of the diameter of the higher vena cava.   "
182871|NCT00236275|"     Predict and follow thanks to imaging the response to neoadjuvant chemotherapy in locally     advanced breast carcinoma. Hypothesis : FLT-(18F)PET will be a predictor superior to both     FDG-(18F) PET and MRI   "
182872|NCT00236288|"     To test the feasibility of an intensive behavioral and pharmacologic tobacco cessation     program for radiation oncology patients and their families/companions.   "
182873|NCT00236301|"     Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone     replacement therapy on inflammatory markers are dose-dependent.   "
182874|NCT00236327|"     The purpose of this study is to determine the safety and efficacy of pain control by     fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour     in 80 out-patients with intense chronic cancer pain. Higher doses are allowed by permission     of the investigator and rescue oral morphine medication is allowed.   "
182875|NCT00236340|"     To compare the efficiency and maternal and fetal tolerance of two techniques of     amnioreduction used in cases of symptomatic second and third trimester polyhydramnios:     syringe manual aspiration technique (S group) and continuous suction technique (C group) set     to – 250 mmHg   "
182876|NCT00236353|"     The purpose of this study is to assess the effectiveness and safety of long-acting     risperidone given as a once monthly injection to adult patients with schizophrenia or     schizoaffective disorder.   "
182926|NCT00237003|"     The purpose of this study is to examine the efficacy of a brief motivational intervention for     alcohol use in incarcerated women.   "
182877|NCT00236366|"     The purpose of the study is to determine if fentanyl, delivered through the skin via an     adhesive patch, has a superior pain-relieving effect compared with placebo in patients with     osteoarthritis pain that is inadequately controlled by therapeutic treatment with weak     opioids, which are often taken in combination with non-opioid analgesics.   "
182878|NCT00236379|"     The purpose of this study is to assess and compare how risperidone and olanzapine, two     antipsychotic medications, affect the regulation of glucose (sugar) in the body.   "
182879|NCT00236392|"     The purpose of this study is to assess the efficacy and safety of long-term, on-demand     maintenance therapy with rabeprazole in patients with non-erosive reflux disease (NERD).   "
182880|NCT00236405|"     The purpose of this study is to compare the effect of perioperative administration of PROCRIT     to that of autologous blood donation on post-operative rehabilitation outcomes in patients     undergoing unilateral knee surgery.   "
182881|NCT00236418|"     The purpose of this study is to evaluate the efficacy and safety of topiramate as an add-on     therapy in epilepsy patients with uncontrolled primary generalized tonic-clonic seizures, who     are taking 1 or 2 standard antiepileptic drugs.   "
182882|NCT00236431|"     The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in     patients with mild cognitive impairment.   "
182883|NCT00236444|"     The purpose of this study is to assess the efficacy and safety of risperidone as maintenance     therapy to prevent symptoms of relapse in children and adolescents with conduct and other     disruptive behavior disorders, who initially responded well to treatment.   "
182884|NCT00236457|"     The purpose of this study is to document both short-term, as well as long-term efficacy and     safety of a long-acting injectable formulation of risperidone, in comparison with olanzapine     for the treatment of patients with schizophrenia or schizoaffective disorder.   "
182885|NCT00236470|"     The primary purpose of this study is to document the long-term safety of an oral formulation     of risperidone in the treatment of children and adolescents with conduct and other disruptive     behavior disorders. Data on the efficacy of the drug will also be collected. Only patients     who were enrolled in the previous related study would be eligible to participate.   "
182886|NCT00236483|"     The purpose of this study is to explore the pain-relieving effects and safety of two     analgesic treatment regimens as compared to placebo in patients experiencing pain after oral     surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain. This study     will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared     with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment     of pain following oral surgery.   "
182887|NCT00236496|"     The purpose of this study is to assess the safety and effectiveness of topiramate as compared     to placebo in treating patients with tremor of unknown cause.   "
182888|NCT00236509|"     The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate     (50 milligrams[mg], 100mg, and 200mg taken daily) compared with placebo in the prevention of     migraine.   "
182889|NCT00236522|"     The purpose of this study is to evaluate the effectiveness and safety of two antibiotic     regimens in the treatment of acute bacterial sinusitis (sinus infection) in non-hospitalized     adult patients. A 5-day course of 750 milligrams of levofloxacin given by mouth once daily     will be compared to a 10-day course of 500 milligrams of levofloxacin given by mouth once     daily.   "
182890|NCT00236535|"     The purpose of this study is to explore the pain-relieving effects and safety of two     analgesic treatment regimens as compared to placebo in patients experiencing acute     musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal     pain from an ankle sprain severe enough to require prescription pain relief medication will     be randomized to receive either tramadol HCl/acetaminophen, hydrocodone     bitartrate/acetaminophen or placebo.   "
182891|NCT00236548|"     The purpose of this study is to assess the usefulness of the RisperdalÂ® ConstaÂ® Treatment     Guidebook in helping the doctor switch the adult patient from taking risperidone tablets     daily by mouth to taking long-acting risperidone by injection. The study will also evaluate     the effectiveness and safety of long-acting risperidone and its effect on patient     satisfaction.   "
183124|NCT00238810|"     The purpose of this study is to assess brain natriuretic peptide levels to evaluate the     relationship of those levels with the diagnosis of congenital cardiac disease, operation     performed, post-operative course, and outcome.   "
182892|NCT00236561|"     The purpose of this study is to evaluate the safety and efficacy of two doses of topiramate     (100 and 200 mg daily) versus placebo and propranolol in the prevention of migraine. The     study will also assess dose response relationship of topiramate, estimate the relative     efficacy of topiramate versus propranolol in prevention of migraine, and evaluate the effect     of migraine prevention with topiramate versus placebo on Health Related Quality of Life.   "
182893|NCT00236574|"     The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in     patients with mild cognitive impairment.   "
182894|NCT00236587|"     The purpose of this study is to document the long term safety of a long-acting injectable     formulation of risperidone in the treatment of patients with schizophrenia who have     previously been treated with long-acting risperidone. Efficacy will also be evaluated.   "
182895|NCT00236600|"     The purpose of this study is to compare the efficacy and safety of topiramate 96mg and 192mg     daily) with placebo in the treatment of obesity following an intensive non-pharmacologic     weight loss program.   "
182896|NCT00236613|"     The purpose of this study is to compare the safety and effectiveness of topiramate (64mg,     96mg, 192mg, and 384mg daily) with placebo in the treatment of obesity.   "
182897|NCT00236626|"     The purpose of this study is to investigate (1) the effect of topiramate on insulin     sensitivity in overweight or obese patients with type 2 diabetes mellitus and (2) the safety     of topiramate in type 2 diabetic patients. The study will also investigate the effect of     topiramate on body weight, body fat, fat distribution, and metabolic control including both     glucose and lipid levels.   "
182898|NCT00236639|"     The purpose of this study is to compare the efficacy and safety of topiramate (96, 192, and     256mg daily) with placebo in long-term treatment of obesity.   "
182899|NCT00236652|"     The purpose of this study is to evaluate the effectiveness and safety of a once-daily     administration of 750 milligrams levofloxacin (an antibiotic) for five days, in treating     bacterial sinus infections.   "
182900|NCT00236665|"     The purpose of this study is to compare the efficacy and safety of daily topiramate (96mg or     192mg) versus placebo in obese patients with mild to moderate high blood pressure.   "
182901|NCT00236678|"     The purpose of this research study is to determine fatigue (tiredness) in subjects with     chronic Rheumatoid Arthritis with chronic anemia. Fatigue in subjects who get PROCRIT will be     compared to fatigue in subjects who get placebo (a medically inactive substance). The study     will also evaluate hemoglobin levels (oxygen-carrying protein in red blood cells), safety,     anemia related health concerns, vitality, arthritis related function and work productivity.   "
182902|NCT00236691|"     The purpose of this study is to evaluate the efficacy and safety of topiramate as add-on     therapy in patients with difficult to control partial onset seizures who are taking one or     two standard antiepileptic drugs.   "
182903|NCT00236704|"     The purpose of this study is to evaluate the effectiveness and safety of topiramate as an     add-on therapy in epilepsy patients with uncontrolled primary generalized tonic-clonic     seizures, who are taking 1 or 2 standard antiepileptic drugs.   "
182904|NCT00236717|"     The purpose of this study is to compare the effectiveness and safety of topiramate to     standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.   "
182905|NCT00236730|"     The purpose of the study is to evaluate the effectiveness and safety of topiramate as add-on     therapy in patients with difficult to control partial onset seizures who are taking one or     two standard anti-epileptic drugs.   "
182906|NCT00236743|"     The purpose of this study is to evaluate the safety and effectiveness of oral topiramate as     add-on therapy in children with uncontrolled partial onset seizures who are taking one or two     standard anti-epileptic drugs.   "
182907|NCT00236756|"     The purpose of this study is to evaluate the effectiveness and safety of topiramate as add-on     therapy in the treatment of epilepsy patients with Lennox-Gastaut syndrome, a severe form of     epilepsy in which there are mixed types of seizures.   "
182908|NCT00236769|"     The purpose of the study is to evaluate the contraceptive efficacy, safety, cycle control,     and compliance with the transdermal contraceptive system.   "
182909|NCT00236782|"     The purpose of the study was to compare the contraceptive efficacy and safety of the     transdermal patch to Mercilon.   "
182910|NCT00236795|"     The purpose of the study was to compare the contraceptive efficacy and safety of the     transdermal patch to Triphasil.   "
182911|NCT00236808|"     The purpose of this study is to compare the safety and effectiveness of levofloxacin to     ciprofloxacin in patients with chronic bacterial prostatitis.   "
182912|NCT00236821|"     The purpose of this study is to evaluate the effectiveness and safety of two antibiotic     regimens in the treatment of community-acquired pneumonia in non-hospitalized adult patients.     A 5-day course of 750 milligrams of levofloxacin given once daily will be compared to a     10-day course 500 milligrams of levofloxacin given once daily.   "
182913|NCT00236834|"     The purpose of this study is to compare the safety and effectiveness of levofloxacin with     imipenem/cilastatin in the treatment of hospital-acquired pneumonia   "
182914|NCT00236847|"     The purpose of this study is to evaluate the effectiveness and safety of topiramate as an     add-on therapy in patients with uncontrolled partial onset seizures who are taking one or two     standard antiepileptic drugs.   "
182915|NCT00236860|"     The purpose of this study is to evaluate the efficacy and safety of topiramate as add-on     therapy in epilepsy patients with difficult to treat, partial-onset seizures who are taking     one or two standard anti-epileptic drugs.   "
182916|NCT00236873|"     The purpose of the study is to evaluate the efficacy and safety of topiramate in epilepsy     patients with difficult to treat, partial-onset seizures who are taking one or two standard     antiepileptic drugs.   "
182917|NCT00236886|"     The purpose of this study is to assess a possible predictor for weight loss seen in epilepsy     patients treated with topiramate.   "
182918|NCT00236899|"     Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate     time to progression disease (PD).   "
183163|NCT00240864|"     The purpose of this study is to determine the onset of pain relief from a single dose of     acetaminophen and ibuprofen in subjects experiencing postoperative dental pain following the     surgical extraction of at least three molars.   "
182919|NCT00236912|"     The purpose of this study is to compare the efficacy and safety of two treatment regimens in     treating patients with complicated appendicitis. Appendicitis requires antibiotic treatment     when the appendix ruptures (complicated appendicitis). This is a study comparing intravenous     (IV) antibiotic therapy of levofloxacin/metronidazole versus piperacillin/tazobactam for 4 to     14 days. Patients may be switched to oral therapy after 48 hours, at the doctor's discretion.   "
182920|NCT00236925|"     This study is based on clinical findings that some patients with fibromyalgia have a tendency     towards lower levels of the stress hormone cortisol. The hypothesis to be tested in this     study is that the administration of a very low-dose of cortisol which has no side effects     corrects this deficiency and results in an improvement of symptoms   "
182921|NCT00236938|"     This is a open-label, prospective study comparing intravenous (IV) iron supplementation to     standard care in anemic patents undergoing peritoneal dialysis.   "
182922|NCT00236951|"     To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly,     fixed doses of erythropoietin in patients who had or had not responded to erythropoietin     therapy alone.   "
182923|NCT00236964|"     The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus     erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic     renal failure who are not receiving dialysis.   "
182924|NCT00236977|"     To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in     non-dialysis dependent, chronic renal failure in patients receiving or not receiving     erythropoietin.   "
182925|NCT00236990|"     The purpose of this study is to evaluate the safety and effectiveness of ELMIRONÂ® in the     treatment of chronic non-bacterial inflammation of the prostate gland.   "
182927|NCT00237016|"     Abstract Background Tick-Borne Relapsing Fever (TBRF) is an acute febrile illness. In Israel,     TBRF is caused by Borrelia persica and is transmitted by Ornithodoros tholozani ticks. We     examined the safety and efficacy of a post exposure treatment policy to prevent TBRF.      Methods In a double blind, placebo controlled trial 93 healthy volunteers with suspected tick     exposure (51 with bite signs and 42 contacts) were randomly assigned to receive either     Doxycycline (200 mg for the first day and 100mg/d for 4 days) or placebo, approximately 2     days after contact. Blood smears were examined for Borrelia at inclusion and during fever     rise. Serology for Lyme disease cross- reactivity and PCR for Borrelia GlpQ gene were also     performed. Cases of TBRF were defined as subjects having fever and a positive blood smear.   "
182928|NCT00237042|"     The purpose of this study is to determine whether treatments targeted to the hormonal factors     and the cyclicity of TMD symptoms associated with the menstrual cycle are more effective in     relieving TMD pain and symptoms than standard self management treatment.   "
182929|NCT00237055|"     Six sites of the Pediatric Inflammatory Bowel Disease Consortium (plus 2 additional sites)     will participate in this study. The participating sites will be that of the Principal     Investigator (PI), Emory University School of Medicine, Atlanta, GA (Benjamin D. Gold, MD);     Texas Children's Hospital / Baylor College of Medicine (George Ferry, MD and Tony Olive, MD);     Children's Hospital of Philadelphia, Philadelphia, PA (Bob Baldassano, MD); University of     Chicago Children's Hospital, Chicago, IL (Barbara Kirschner, MD); University of California,     San Francisco (Mel Heyman, MD); Mass General Hospital / Harvard University (Harland Winter,     MD); V.A. Stanford University School of Medicine, Stanford, CA (David Relman, MD); Children's     Center For Digestive Healthcare, Atlanta, GA (Stanley Cohen, MD); and Centers for Disease     Control and Prevention, Atlanta, GA (Drs. Jeannette Guarner, Siobhan O'Connor and Thomas     Shinnick)      The duration of study is 2 yrs.      Objectives:        1. Improve the methods to collect biopsies from the colon and ileum, tissue storage          techniques and best methods to detect specific infections in children with Crohn's          disease;        2. Determine if there are specific infectious agents that are more common in children with          Crohn's disease, and;        3. Determine if there are types of children with Crohn's disease (e.g., children living in          Boston, African American children) who may be more at risk for getting the infections.      The study design involves children ages 6 months through 17 11/12 years of age who are     undergoing a clinically-indicated colonoscopy. Subjects will be grouped into cases and     controls.        -  Any child ages 6 mos through 17 11/12 years of age, undergoing a clinically-indicated          colonoscopy as determined by the treating physician, is eligible for enrollment. About          500 patients will be enrolled in this study.        -  Cases will consist of those children within the defined age group, who are undergoing          diagnostic colonoscopy and have the definitive diagnosis of Crohn's disease.        -  Children who have the diagnosis of indeterminate colitis or ulcerative colitis for the          purpose of this R03, will be excluded as cases and from initial analysis, but will have          tissue specimens banked for subsequent evaluation for infectious agents.        -  Controls will consists of children within the defined age group, undergoing clinically          indicated colonoscopy and who are not diagnosed with Crohn's disease, ulcerative colitis          or indeterminate colitis (e.g., juvenile polyps, irritable bowel syndrome or functional          bowel disease).        -  Stool specimen (5ml/1 tsp) will be collected to test for different types of bacteria        -  A questionnaire will be administered to each research volunteer.        -  Each subject's medical information (i.e. diagnosis, disease stage, and laboratory          results) will be stored electronically in a separate access-based database. A unique          identifier will be assigned to each patient entered into the study and will also be used          for blinding of the specimens analyzed by the pathologist and by molecular assays for          infectious agents.        -  Colonoscopy will be performed by the treating pediatric gastroenterologist and biopsies          obtained in the usual standard of care.        -  Clinical biopsies from the rectum, left, right, transverse colon and cecum will be          placed in formalin containing vials as per standard of care for the clinical pathologist          and diagnostic evaluation.   "
182930|NCT00237068|"     Asthma and gastroesophageal reflux disease (GERD) are common disorders, which although are     not usually lethal, both have high morbidity, and high healthcare costs. Recent studies have     demonstrated that asthma and GERD often co-exists, and that this co-existence is more     frequent than just chance. Therefore, studies that characterize associations between these     conditions, and, help in the development of interventions will positively impact the outcomes     of these patients, which are critically needed.      Subjects that participate in this study are required to be between the ages of 4-11 years     old. This protocol proposes to enroll 100 children with asthma, on inhaled steroids who have     poor asthma control, defined on the basis of frequent symptoms, excessive beta-agonists use,     or frequent asthma episodes.      The purpose of this research study is to:        1. Determine, whether children with symptomatic, poorly controlled, asthma assigned to          treatment with a PPI( Proton Pump Inhibitor), have fewer asthma exacerbations than          similar participants assigned to placebo for a similar duration of time        2. Determine whether children treated with Lansoprazole ( i.e., proton pump inhibitor):          have a longer time to first exacerbation, have improved lung function, improved asthma          symptom scores, improved quality of life, decreased rescue inhaler use, or other asthma          medications, reduced emergency room/urgent care/ physician office visits that are asthma          related.        3. Determine whether a subgroup of symptomatic asthmatics, who show a greater benefit from          PPI's, can be identified.   "
182931|NCT00237081|"     The cause of interstitial cystitis is unknown. However, it tends to run in some families     suggesting that there may be a genetic susceptibility to the disease. For instance, the     disease is found 17 times more commonly in first-degree relatives (parent, sibling, or child)     of patients with interstitial cystitis than in the general population. Furthermore, if one     twin has interstitial cystitis, the disease is much more common in identical co-twins than     fraternal co-twins. This evidence suggests that, in some families, genes that make a person     susceptible to interstitial cystitis are being passed from one generation to the next.      The University of Maryland School of Medicine and the National Institutes of Health are     performing a study to identify these genes for susceptibility for interstitial cystitis. This     study is entitled the Maryland Genetics of Interstitial Cystitis (MaGIC) study. The MaGIC     study will investigate several hundred families with two or more blood relatives with     interstitial cystitis. The study will seek to find changes in genes that are found far more     commonly in family members who have interstitial cystitis than in those who do not have the     disease.Identifying these genes should lead to a better understanding of the cause of     interstitial cystitis. Finding the cause is the first step to finding the cure.      This is a national study which is conducted by telephone and mail, and in which you can     participate entirely from your home.   "
182951|NCT00237341|"     The purpose of this study is to assess physical functionality changes over a minimum of 9     weeks in patients with non-malignant chronic low back pain who are taking short-acting     opioids (narcotic pain medications) for 4 or more weeks, and who start taking the long-acting     opioid fentanyl in the form of a transdermal (skin) patch.   "
182952|NCT00237354|"     The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the     treatment of recurrent breast carcinoma. This study will also include a preliminary     assessment of response of injected lesions by histologic assessment upon lesion excision at     1-3 weeks following IL PV-10 administration. Post-excision wound healing will be assessed     clinically at 1 week and 4 weeks following excision of PV-10 injected lesions.   "
182932|NCT00237094|"     Studies have demonstrated that intensive disease management of diabetes and its associated     risk factors, hypertension and dyslipidemia, can prevent the progression of vascular     complications. However, implementation of well defined guidelines for intensive disease     management has been suboptimal. Barriers to success occur at multiple levels, including     health care systems, health care providers and patients.      In rural regions of the U.S., reduced availability of primary care providers and specialty     services, including diabetes education, present additional barriers to effective diabetes     care. Use of a nurse practitioner led interdisciplinary team to intensively manage urban and     rural diabetic patients, utilizing telehealth technology to provide care to rural areas, will     help begin to address these barriers      The long term goal of the project is to develop a practical and sustainable system of     intensive diabetes management that will be effective in helping diabetic patients achieve and     maintain goals within established treatment guidelines regardless of geographic location.      Specific aims are:        1. To determine in both urban and rural areas if a nurse practitioner led team approach to          intensive diabetes management and education improves disease-specific outcomes and          patient education compared to traditional care (current diabetes management of urban          patients).        2. To determine if telehealth is an effective and accepted mechanism for delivery of a          nurse practitioner led team approach to intensive diabetes management and education in          rural areas.        3. To determine if a nurse practitioner led intensive disease management team can identify          patient risk factors (psychological, financial, and work-related factors) that may be          barriers to patient adherence, earlier in the management of urban diabetic patients          compared to traditional care.        4. To compare volume and type of service utilization of a nurse practitioner led team          approach to diabetes management and education to that of traditional care in both urban          and rural areas. Disease-specific outcomes will include physiologic variables (HbA1c,          blood pressure, lipid levels), measurement and documentation of preventive services          (dilated eye exam, monofilament exam, microabumin testing) and patient's knowledge of          disease tested by questionnaire.      Results should show improved outcomes and patient knowledge in urban and rural patients     receiving intensive disease management compared to traditional care.   "
182933|NCT00237107|"     The aim of this study was to compare histologically observed tumour infitration of basal cell     carcinoma (bcc) lesions before and after curretage.A significant reduction of tumour depth     would enable further bcc's included for superficial non-invasive treatment modalities such as     topical photodynamic therapy.   "
182934|NCT00237120|"     This study will assess the safety and efficacy of imatinib in newly enrolled previously     untreated patients with chronic phase CML.   "
182935|NCT00237133|"     Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for     patients with locally advanced breast in postmenopausal women expressing hormonal receptors (     ER and PR)   "
182936|NCT00237146|"     An open, multicenter and prospective study to evaluate the impact of the treatment with     zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with     prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is     given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event     occurs.   "
182937|NCT00237159|"     It is the aim of this clinical study to evaluate the skeletal-related event rate and     tolerability of zoledronic acid in patients with prostate cancer patients and bone     metastases.   "
182938|NCT00237172|"     This is a extension study of CSTI571B1201 study   "
182939|NCT00237185|"     In the core study, participants with unresectable or metastatic gastrointestinal stromal     tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3     years. The 10 year extension study allowed participants, who successfully completed the core     study, to continue study treatment with imatinib mesylate provided they still benefited from     treatment and did not demonstrate safety concerns as per the investigator's opinion.   "
182940|NCT00237198|"     -  Safety and efficacy of letrozole 2.5 mg/day monotherapy as second-line endocrine therapy          in postmenopausal patients with advanced breast cancer who received previous          anti-estrogen treatment        -  To investigate changes in blood drug concentrations and blood hormone kinetics.        -  To investigate gene polymorphisms of CYP2A6, an enzyme involved in the metabolism of          letrozole   "
182941|NCT00237211|"     To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in     postmenopausal patients with breast cancer, and to determine the blood concentrations of     letrozole and hormones.   "
182942|NCT00237224|"     To evaluate safety and efficacy (measured by clinical tumor response) of letrozole daily     dose, 2.5 mg in postmenopausal patients with primary (untreated) breast cancer.   "
182943|NCT00237237|"     Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a     single oral drug. The purpose of this study is to assess the long-term safety and     effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in     lowering overall blood glucose levels when added to metformin in people with type 2 diabetes     not at target blood glucose levels on metformin alone.   "
182944|NCT00237250|"     The purpose of this study is to assess the safety and effectiveness of vildagliptin, an     unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people     with pre-diabetes who have high blood sugar levels after meals.   "
182945|NCT00237263|"     The purpose of this study is to evaluate the safety and efficacy of the long-term treatment     of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.      This study is not recruiting patients in the United States.   "
182946|NCT00237276|"     The study looks at 2 hypotheses in 2 patient groups:        1. Are more experienced endoscopists better at detecting subtle lesions (polyps) on the          lining of the colon (large bowel) than less experienced endoscopists?        2. Do existing and new techniques that can highlight lesions on the lining of the bowel          improve endoscopists ability to spot them? This will be tested using video footage of          endoscopies from 2 patient groups: those with a normal colon linig and those with          colitis (bowel lining inflamation)   "
182947|NCT00237289|"     The purpose of this study is to assess the efficacy and safety of adding topiramate as     compared to placebo to the medications a patient with bipolar disorder is already taking     (lithium or valproate) to see if adding topiramate will better control the patient's manic     symptoms.   "
182948|NCT00237302|"     The purpose of this study is to assess the safety and efficacy of topiramate as compared to     placebo in preventing migraines in children.   "
182949|NCT00237315|"     Urea cycle disorders (UCD) are a group of rare inherited metabolism disorders. Infants and     children with UCD commonly experience episodes of vomiting, lethargy, and coma. The purpose     of this study is to perform a long-term analysis of a large group of individuals with various     UCDs. The study will focus on the natural history, disease progression, treatment, and     outcome of individuals with UCD.   "
182950|NCT00237328|"     Heparin is a drug that is widely used to prevent and treat blood clotting. Individuals     undergoing cardiopulmonary bypass surgery are administered high doses of heparin, and some of     them develop antibodies to the drug. This immune response can lead to the formation of blood     clots, setting the stage for a potential heart attack or stroke. The purpose of this study is     to evaluate how often an immune response to heparin leads to the formation of blood clots in     individuals who have had heart surgery.   "
182953|NCT00237367|"     The purpose of the study is to compare the pharmacodynamics (the way a drug works in the     body) of rabeprazole and pantoprazole on intragastric acidity and esophageal acid exposure in     gastroesophageal reflux disease (GERD) patients with nighttime heartburn. Patients will be     given one dose of each medication with a washout period of 6 to 13 days between doses     (washout period means they will receive no further proton pump inhibitor medication for     6-13 days, allowing the 1st dose to completely leave their bodies). Rabeprazole is approved     in the United States for the short-term treatment (4-8 weeks) in the healing and symptomatic     relief of erosive or ulcerative GERD with symptoms of daytime or nighttime heartburn,     maintenance of healing of erosive or ulcerative GERD, and treatment of symptomatic GERD. The     dosage regimen for all GERD indications is 20 mg once a day. Other indications include     healing of duodenal ulcers, Helicobacter pylori eradication to reduce the risk of duodenal     ulcer recurrence, and treatment of pathological hypersecretory conditions including     Zollinger-Ellison Syndrome. The most common side effect of rabeprazole is headache. In     clinical trials headache was assessed as possibly related to rabeprazole in 2.4% of subjects     vs. 1.6% for placebo. Pantoprazole at a dose of 40 mg once a day is indicated for the     short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive     esophagitis, and the maintenance of healing of erosive esophagitis and reduction in relapse     rates of daytime and nighttime heartburn symptoms in patients with GERD. Other indications     include pathological hypersecretory conditions including Zollinger-Ellison Syndrome. The most     common side effects are headache and diarrhea.   "
182995|NCT00237926|"     The purpose of this study is to compare the health outcomes of a 12-week exercise program     focused on aerobic training (using a treadmill) to a 12-week exercise program focused on     resistance training (using Thera-Bands) in sedentary patients within 6 months of completing     treatment for cancer.   "
182954|NCT00237380|"     In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation     (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator     (CFTR) protein. PTC124 has been shown to partially restore CFTR production in animals with CF     due to a nonsense mutation. The main purpose of this study is to understand whether PTC124     can safely increase functional CFTR protein in the cells of patients with CF due to a     nonsense mutation.   "
182955|NCT00237393|"     The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.   "
182956|NCT00237406|"     This study is designed to test whether a telephone call-in program is a feasible way to     collect mood and drug-related information in individuals enrolled in a methadone maintenance     program.   "
182957|NCT00237419|"     Ankylosing spondylitis (AS) is a chronic inflammatory disease that involves the sacroiliac     joints, axial skeleton, entheses and peripheral joints. Current therapy for AS is mainly     NSAIDs and physiotherapy which are oft insufficient. Treatment with the TNF-alpha blocking     agent infliximab was shown to have definite clinical efficacy in patients with active AS on a     short- and a long-term-basis over 2 years. We want to show that treatment with infliximab on     a long-term basis over 4 years is safe and efficient and can prevent radiographic progression     over a long period of time. Further we want to learn about the outcome after discontinuation     of anti-TNF-alpha therapy.   "
182958|NCT00237432|"     The purpose of this study is to investigate the mechanism of a successful immune response to     hepatitis C virus (HCV) infection. Currently, it is believed that the immune system is     involved in responding to HCV infection, but how it is involved is not known. It is estimated     that 30% of individuals infected with HCV are able to clear the virus without treatment,     while 70% progress to chronic infectious. By studying the immune responses in these two     populations, we, the researchers at Rockefeller University, hope to gain insight into the     mechanisms of the immune response and develop new strategies for HCV therapy.   "
182959|NCT00237445|"     A multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal     resistance comparing the clinical efficacy and health outcomes of outpatients with mild to     moderate Community-Acquired Pneumonia (CAP) treated with either telithromycin once daily for     7 days, or azithromycin once daily for 5 days   "
182960|NCT00237458|"     This trial is the follow-on trial to a preceeding open-label trial which included patients     with chronic refractory neuropathic pain. It is conducted at one site in the United Kingdom     and the patient enrollment is completed. The patients had successfully completed the above     mentioned trial and, in the investigator's opinion, would benefit from long-term     administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to     their optimal dose and then continued into the maintenance phase. Different pain qualities     are assessed by a patient's diary.   "
182961|NCT00237471|"     To determine whether tight glycaemic control with insulin improves myocardial function and     myocardial perfusion (measured by myocardial contrast echocardiography) and novel vascular     risk factors in patients with acute myocardial infarction and hyperglycaemia.   "
182962|NCT00237484|"     This is a Phase IIIB, randomized, prospective, multicenter, single-country, open-label,     controlled pilot trial designed to evaluate the effect of infliximab induction therapy on     sustained virologic response (SVR) to treatment with pegylated interferon alfa-2b plus     ribavirin in a group of 96 therapy-naïve subjects with genotype 1 hepatitis C virus (HCV)     infection and high serum tumor necrosis factor (TNF)-alpha values.   "
182963|NCT00237497|"     The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily     (QD), compared to placebo with Zopiclone in adults with chronic insomnia   "
182964|NCT00237510|"     This study is based on the hypothesis that terazosin, a blocker of alpha-1 receptors, will be     effective in reducing excessive sweating caused by antidepressant treatment, and will have     minimal adverse effects.   "
182965|NCT00237523|"     -  History of clinical breast pain for at least the last six months.        -  At least six days of moderate or severe breast pain per cycle.        -  Fibrosis, cysts, nodules involving at least 25% of the surface of one breast.        -  Euthyroid with no prior history of thyroid disease.        -  Six months of daily therapy with molecular iodine.        -  Placebo controlled vs active (1:1).   "
182966|NCT00237536|"     The purpose of this trial is to evaluate the dose response relationship of lonidamine and the     primary efficacy endpoint, International Prostate Symptom Score (IPSS), in subjects with     symptomatic benign prostatic hyperplasia (BPH).   "
183003|NCT00238030|"     To compare oral versus intravenous administration of thyroid hormone: 1) for reversibility of     hemodynamic instability in organ donors, and, 2) the pharmacokinetics of oral vs iv thyroid     administration   "
183164|NCT00240877|"     To assess the safety of a vaccine in healthy adults prior to the release of the trivalent     vaccine (FluMist).   "
182967|NCT00237549|"     The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment     compared to standard treatment.        1. In the screening study, the feasibility and results of country specific models to          identify undiagnosed individuals with Type 2 diabetes will be evaluated.        2. In the treatment study the effects of routine care in general practice according to          local and national guidelines will be compared with an intensive ADDITION protocol,          including structured lifestyle education (dietary modification, increased physical          activity and smoking cessation) and intensive treatment of blood glucose, blood pressure          and lipids, and prophylactic aspirin with or without motivational interviewing, on          mortality, macrovascular and microvascular disease. Furthermore the impact of treatment          on health status, treatment satisfaction and health service costs will also be assessed.   "
182968|NCT00237562|"     1. Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a          multi-ethnic population of women;        2. Set up an efficient system for interpretation of Pap smears for patients in the SVP that          will minimize waiting time;        3. Determine the follow-up rates and compare them between women assigned to the SVP and a          usual care program (UCP);        4. Determine satisfaction and compare it between women assigned to the SVP and the UCP;        5. Determine the cost-effectiveness and compare it between the SVP and UCP   "
182996|NCT00237939|"     The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be     effective, safe and well tolerated in the treatment of patients with schizophrenia who are     treated in a general psychiatric setting.   "
182969|NCT00237575|"     The main objective of this study is to compare the effectiveness of Leukine & Neupogen to     decrease the incidence of grade 3 & 4 neutropenia in the treatment of patients receiving     cisplatin & gemcitabine for urothelial (bladder) cancer.      All patients will receive chemotherapy with cisplatin plus gemcitabine in six 21-day cycles.     Patients will also receive either Leukine (Arm A) or Neupogen (Arm B).      Patient Population: 100 patients will be enrolled (n=100) in this study. Patients cannot have     undergone previous chemotherapy. Approximately 50 patients will be enrolled into each     treatment arm.      Test Product, Dose, Mode of Administration: All patients will receive chemotherapy treatment     with cisplatin (70 mg/kg) on Day 1 and gemcitabine (1000 mg/m2) on Days 1, 8, & 15 of each     21-day cycle. Patients will be randomized to receive either Leukine (250 µg/m2) or Neupogen     (5 µg/kg) injected under the skin on Days 2-6, 9-13, & 16-20 of each cycle.      Duration of Treatment: Patients will receive a maximum of six 21-day cycles of treatment. The     overall trial, including follow-up, is expected to be 3 years in duration.   "
182970|NCT00237588|"     To determine if angiotensin-II AT-1 receptor blockade(ARB) may improve insulin sensitivity     assessed by the hyperinsulinaemic isoglycaemic glucose clamp, more than CCB therapy at a     comparable dose with regards to the blood pressure-lowering effect.   "
182971|NCT00237601|"     In the Netherlands, which has about 200.000 births per year, maternity care is provided by     midwives or general practitioners unless medical reasons necessitate specialist obstetric     care. Women with low risk pregnancies are free to decide where to give birth, attended by     their midwife or general practitioner, at home or in the hospital, from which they are then     discharged within 24 hours. In the Netherlands these hospital births are referred to as     poliklinische bevallingen (i.e. outpatient deliveries) to indicate that they do not involve     formal hospitalisation, or as verplaatste thuisbevalling (i.e. relocated home births) to     indicate that they are supervised by the same caregivers as the home births without     involvement of specialist obstetricians.      In the last two decades a marked increase in the referral rate to obstetricians during     childbirth has occurred, especially for nulliparae, both in planned home births and planned     hospital births (outpatient deliveries). 90% from all primigravidae will start their     pregnancy under care of the primary caregiver (midwife of general practitioner). During the     pregnancy 30% will be referred to the secondary caregiver (obstetrician specialist). The     other 60% will start labor guided by the primary caregiver. More than 50% of these women will     be referred to the obstetrician during labor.      Despite this unique situation of the Dutch maternity care, the differences between home and     hospital birth (outpatient deliveries) with regard to effectivity and efficiency have never     been investigated. It is also unclear if pregnant women are informed about a 50% risk of     being transported to the secondary caregiver/ hospital during labor at home. Neither do we     know what their experiences are.      This study aims to investigate the differences between home and hospital deliveries under     care of the primary caregiver with regard to effectivity (costs) and efficiency (patient     satisfaction) of care.   "
182972|NCT00237614|"     Patients with acute myocardial infarction undergoing primary angioplasty are at high risk for     renal injury due to the toxic effect of contrast agents. Patients developing renal     dysfunction after primary angioplasty have worse outcome. To investigate the role of the     antioxidant N-acetylcysteine (NAC) in preventing renal injury in angioplasty, we randomized     352 consecutive patients undergoing primary angioplasty into three groups: the first group     received NAC at standard dose (NAC group, 600 mg i.v. bolus before primary angioplasty,     followed by oral 600 mg twice daily for the following 48 hours; n=115), the second group     received NAC at double dose (DD-NAC group; 1,200 mg i.v. bolus and oral 1,200 mg twice daily     for 48 hours; n=118), and the last group received placebo (controls; n=119).   "
182973|NCT00237627|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Giving doxorubicin hydrochloride liposome together with     bortezomib may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when     given together with doxorubicin hydrochloride liposome and to see how well they work in     treating patients with refractory hematologic cancer or malignant solid tumor or metastatic     breast cancer.   "
182974|NCT00237640|"     The purpose of this study is to determine the effects of cinnamon on serum glucose and lipid     levels in people with non-insulin dependent type 2 diabetes mellitus.   "
182975|NCT00237653|"     The main objective of this study is to demonstrate the relevance of Valganciclovir on     recurrent bouts of cryptogenic inflammatory bowel diseases with infection by cytomegalovirus     (CMV). The goal is to obtain 90% (for Valganciclovir treated patients) versus 50% (for     placebo treated patients) remission at 3 months (including the discontinuation of corticoids     or reducing their dose to under 20 mg of prednisone equivalence), without any relapse over     the 6 following months.   "
182976|NCT00237666|"     The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the     treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a     major depressive episode.   "
183004|NCT00238043|"     The purpose of this study is to establish the long-term safety and efficacy of Biogeneric     Epoetin, the attainability of therapeutic target for anaemia management, and the impact of     Epoetin treatment on long-term health outcome and its cost effectiveness.   "
183005|NCT00238056|"     30 premature infants treated by domperidone upon decision of the attending neonatologist will     have a daily recording of electrocardiogram for the first 7 seven days of treatment, and     pharmacokinetics dosages at Day 7. Their ECG will be compared to 30 non treated premature     infants, matched for gestational age, postnatal age and sex.   "
182988|NCT00237822|"     The investigators are proposing a study of treatment adherence in co-occurring psychiatric     and drug use disorders (COD). The proposed study uses a 3-cell/condition design, within which     75 adult outpatients with co-occurring psychiatric disorders and drug abuse/dependence     (CODDA) will be randomly assigned to one of the following brief, 8-week, manual-guided     interventions following a 2-week “Assessment Only” baseline period:        1. Adherence Feedback (AF); this condition will entail weekly, 20-25 minute sessions of AF,          which is a procedure that represents a technological advancement developed by Cramer et          al. (1989, 1995, and 1999) and is based on the use of adherence data from the          microelectronic monitor in Medication Event Monitoring System (MEMS) caps,        2. AF + Contingency Management (AF + CM); in this condition, participants will receive AF,          as described above, PLUS contingency management. CM is based on the behavioral learning          theory, which suggests that the occurrence of a behavior is increased as a function of          the rate at which it is positively reinforced or rewarded, or        3. AF + Motivational Enhancement Therapy (AF + MET); in this condition, patients will          receive AF, as described above, PLUS motivational enhancement therapy. MET is based on          the idea that an effective way to motivate behavior change is to assist patients in          clarifying their ambivalence (i.e., reasons for and against changing/adhering),          utilizing a series of strategies based on client-centered psychotherapy, self-efficacy          theory, and social psychology.      The study will allow the evaluation of three hypotheses:        1. AF + MET is superior to AF + CM,        2. AF + MET is superior to AF alone, and        3. AF + CM is superior to AF alone.      Primary outcome measures are:        1. rates of adherence to medication (i.e., selective serotonin reuptake inhibitors or          SSRIs), as measured by MEMS caps and self-report,        2. rates of counseling attendance, and        3. reductions in illicit drug use, including achievement of abstinence, as assessed by          twice-weekly urine toxicology tests and self-report.      Secondary outcomes include reductions in psychiatric symptomatology and rates of     re-hospitalization. The investigators will also evaluate the relationship between adherence     and primary and secondary outcomes.   "
182977|NCT00237679|"     The diagnosis and management of childhood dysphonia is a significant clinical problem;     however, there have been few studies aimed at defining standard assessment methods for     pediatric dysphonia. Accordingly, pediatric dysphonia is difficult to diagnose and it is     difficult to quantify change following treatment. The long-term goal of this research program     is to develop valid, responsive, reliable, and age-appropriate methods for assessing vocal     pathology in children. In the present small grant, our objective is to define assessment     methods that are appropriate for use in determining response to treatment. Our main focus,     therefore, is the issue of assessment responsivity. The first specific aim is to develop a     set of responsive measures of vocal pathology in school-aged children by inducing short-term     change in vocal status via behavioral and medical management of extraesophageal reflux     disease (EERD). Because we are treating children suspected of EERD, this study also presents     the opportunity for examining the benefits of combined vocal hygiene and medical management     in the treatment of pediatric EERD. Accordingly, our second specific aim is to determine     predictive criteria for improvement in vocal status in dysphonic children suspected of EERD.     Our hypothesis is that a particular set of measurements will emerge as particularly     responsive to change in vocal pathology in this population, and will allow for informed     prediction of degree of improvement with treatment. The proposed research is significant in     filling a gap in knowledge in childhood dysphonia assessment and treatment, which are     important clinical issues consistent with the mission and intent of the NIDCD. Because     phonatory disorders in children may have lasting negative effects, studies geared toward     accurate assessment and treatment are very important.   "
182978|NCT00237692|"     There are 65 million Americans and over 8.5 million veterans who have been diagnosed with     hypertension; yet only 31% of all hypertensive patients have their blood pressure (BP) under     effective control (less than 140/90 mm/Hg). Uncontrolled hypertension greatly increases the     risk of cerebral vascular accidents, coronary artery disease, myocardial infarction, renal     failure, congestive heart failure, and mortality. Despite the damaging impact of hypertension     and the availability of well-defined therapies and widely accepted target values for BP,     interventions to improve BP control have had limited success.   "
182979|NCT00237705|"     Concussion is defined as any temporary disturbance in brain function following a blow to the     head. It may not involve a loss of consciousness and usually results in a post concussive     headache (PCH) immediately after the injury. Between 30 and 50 percent of patients with     concussion will develop postconcussive syndrome (PCS) consisting of symptoms such as     headache, and a variety of other debilitating symptoms lasting several weeks to months.      The objective of this study is to determine if metoclopramide, a drug commonly used in the     treatment of migraine headache, will be effective in relieving PCH and in preventing PCS.      Eligible patients will have a history of a concussion resulting in headache within the past     24 hours. Patients will rate their pain on a standard scale before and after being treated     with one or two intravenous doses of either metoclopramide or saltwater placebo. They will be     contacted by telephone 1, 4 and 8 weeks later in order to determine if they have developed     the postconcussive syndrome.   "
182980|NCT00237718|"     Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood     markers which their body makes in response to increased stress and injury. An increase in     these markers have been shown to be related to cardiovascular disease and death in ESRD     patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic     acid) may decrease these markers.   "
182981|NCT00237731|"     Efficacy and safety of morphine titration on acute pain in emergency medical mobile units     with initial bolus of 0.1 mg/kg plus 0.05 mg/kg versus morphine titration with initial bolus     of 0.05 mg/kg plus 0.025 mg/kg   "
182982|NCT00237744|"     The long-range goal of this work is to identify how to target treatment so that the brain is     functionally re-organized to produce movement. This study will compare treatment response to     robotics versus functional neuromuscular stimulation.   "
182983|NCT00237757|"     The purpose of the study is to determine if 1. Rehabilitation staff can be trained to work     better together as a team; and 2. Better team work improves patient outcomes.   "
182984|NCT00237770|"     The aim of this investigation is to determine the blood pressure response to NOS inhibition,     with L-NAME, in persons with tetraplegia compared to non-SCI control subjects and to     establish if blood pressure can be increased while upright in those with tetraplegia. If     blood pressure is increased with NOS inhibition in persons with tetraplegia, this would     improve our treatment of the condition of low blood pressure during seated postures in     individuals with tetraplegia.   "
182985|NCT00237783|"     Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis     patients. In this pilot study, we will evaluate the safety and effects of individualizing the     sodium concentration in the dialysate according to the patient's own plasma sodium levels. We     hypothesize that patients will have less thirst and less weight gain during the intervention     leading to easier fluid removal and less episodes of hypotension.   "
182986|NCT00237796|"     The primary purpose of this project is to evaluate the efficacy of a group therapy     intervention, cognitive behavioral social skills training (CBSST), that teaches social     functioning skills and cognitive-behavioral compensatory aids to older patients with     schizophrenia. CBSST, therefore, targets the multidimensional deficits that lead to     disability in aging veterans with severe mental illness.   "
182987|NCT00237809|"     This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (NMDA)     receptor function in the brain and thereby increasing the capacity of the brain to both form     new connections and strengthen existing connections, schizophrenic patients may derive both     greater and sustained benefit from cognitive retraining.   "
183006|NCT00238069|"     This is a research study of asthma and sleep apnea. Our hypothesis is that untreated sleep     apnea causes inflammation in the lung, which can worsen asthma. We believe treatment of sleep     apnea will reduce this inflammation, and improve asthma control. This study will help us     better understand what happens to the lung and bronchial tubes before and after treatment of     sleep apnea, which could benefit all patients with sleep apnea. This study involves 2     bronchoscopies.   "
183183|NCT00241150|"     A STUDY ON WHETHER AN ANTIHYPERTENSIVE MEDICATION PREVENTS DAMAGE TO WALLS OF VEINS IN FEMALE     PATIENTS WITH THE METABOLIC SYNDROME (OVERWEIGHT AND OTHER DISORDERS).   "
182997|NCT00237952|"     Background The relationship between long-term heavy lead exposure and chronic interstitial     nephropathy is well recognized in the previous literatures. Several epidemiological studies     have demonstrated a positive association between blood lead levels and the age related     decreases of renal function in the general population and suggested that environmental     low-level lead exposure may accelerate the progression of renal function in the healthy     persons. In addition, previous our works suggest environmental lead exposure may correlate to     progressive renal insufficiency and lead chelation therapy or repeated lead chelation may     improve and slow the progressive renal insufficiency in non-diabetic patients with chronic     renal diseases. However, Diabetes mellitus is increasing in prevalence worldwide and is     currently estimated to affect more than 6.5 percent of the population of the United States.     In addition, diabetes is the most common cause of end-stage renal disease in many countries,     accounting for about 40 percent of cases. It is still unknown that the relationship between     long-term environmental lead exposure and the progressive renal insufficiency in patients     with type II diabetes and diabetic nephropathy.      Methods Ninety patints with type II diabetes and diabetic nephropathy (serum creatinine     levels between 1.5 mg per deciliter and 3.9 mg per deciliter) who have a normal body lead     burden and no history of exposure to lead or other metals will be observed for 24 months.     Then, about 50 subjects with high normal body lead burdens (at least 80 μg but less than 600     μg) will be randomly assigned to the study and control groups. For three months, the 25     patients in the study group will receive lead-chelation therapy with calcium disodium EDTA     weekly until the body lead burden fallsl below 50 μg, and the 25 control group receive weekly     placebo. During the ensuing 12 months, the renal function will be regularly followed up every     3 months and EDTA mobilization tests will be assessed every 6 months. If body lead burden of     the study group patients increase more than 60μg, the chelation therapy will be performed     again until their body burden are less than 60 μg. The primary end point is an increase in     the serum creatinine level to 2 times the base-line value during the observation period. A     secondary end point is the change in renal function during the follow up period.   "
182998|NCT00237965|"     This study aims to improve Skin Self-Examination accuracy by a simple cost effective     intervention requiring participants to complete a mole-mapping diagram.   "
182999|NCT00237978|"     The aim of the study is to investigate the effectivity of visible light in combination with     waterfiltered infrared in treating acne papulopustulosa. The reduction of inflammatory and     non-inflammatory lesions within 8 weeks will be measured and compared with the standard     treatment with Adapalene.   "
183000|NCT00237991|"     GlaxoSmithKline Korea has submitted a registration file for its hepatitis A vaccine. The     present study will collect clinical data in the local target population as per the     requirement of Korean Food and Drugs administration (FDA).   "
183001|NCT00238004|"     Abnormal blood cholesterol levels increase the risk of developing, or dying from heart     disease. It is well recognised that if harmful LDL cholesterol is high, and protective     HDL cholesterol is low, this risk is increased. Drugs called statins are routinely used in     patients with heart disease, are well tolerated, and decrease the harmful LDL cholesterol     levels. However, statins only increase protective HDL cholesterol to a small extent. Some     patients may thus benefit from additional medication to increase protective HDL-cholesterol     further. One of the most effective drugs which can do this is nicotinic acid. This drug is     well established having been available for over 30 years. Previous use has been limited by     facial flushing in a large percentage of patients receiving the drug. However a new     formulation called Niaspan is now available which is associated with much less flushing.     Although many patients will have transient flushing, it is estimated that only 1 patient out     of every 20 receiving the drug will have to discontinue treatment. We therefore propose, in     patients with coronary artery disease and low HDL cholesterol despite being on a statin, to     study the effect of Niaspan on HDL cholesterol and other lipid parameters, and to assess its     tolerability.   "
183002|NCT00238017|"     The purpose of this study is to compare the efficacy and safety of two antimalarial drug     regimes, namely amodiaquine versus amodiaquine-artesunate, in the treatment of children with     uncomplicated malaria. Also, genetic host factors which might influence efficacy and/or     safety will be examined.   "
189888|NCT00323479|"     The purpose of this study is to describe the joint symptoms and structural joint changes     under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.   "
183007|NCT00238082|"     This is an investigator-sponsored research study to evaluate if treatment with HFA-134a     beclomethasone (QVAR) has an effect on peripheral (or outer) airway inflammation and airway     remodeling or scarring in subjects with COPD. Approximately 20 subjects with COPD will     participate for approximately 7 weeks, with 10 receiving an active (BDP) inhaler with     HFA-134a and 10 receiving a placebo.   "
183008|NCT00238108|"     This study will evaluate the effectiveness of treatment with melatonin supplements in     improving sleep in individuals with high blood pressure who are taking beta-blockers.   "
183009|NCT00238121|"     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. This phase II trial is studying how well     sorafenib works in treating patients with advanced or recurrent uterine cancer.   "
183010|NCT00238147|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, carboplatin, and capecitabine, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine     may also make tumor cells more sensitive to radiation therapy. Giving combination     chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed.      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when     given together with carboplatin and capecitabine followed by chemoradiotherapy in treating     patients who are undergoing surgery for locally advanced esophageal cancer.   "
183011|NCT00238160|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells.     Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known     whether surgery and hepatic arterial chemotherapy are more effective than surgery alone in     treating patients with liver cancer that has spread to the portal vein.      PURPOSE: This randomized phase III trial is studying surgery and hepatic arterial     chemotherapy to see how well they work compared to surgery alone in treating patients with     liver cancer that has spread to the portal vein.   "
183023|NCT00238329|"     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological     therapies, such as thalidomide, may stimulate the immune system in different ways and stop     tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of     melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with     thalidomide may be an effective treatment for melanoma.      PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with     thalidomide works in treating patients with recurrent or metastatic melanoma.   "
183012|NCT00238173|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, etoposide phosphate, and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells. Mannitol may help chemotherapy work better by making it easier for     these drugs to get to the tumor. Chemoprotective drugs, such as acetylcysteine and sodium     thiosulfate, may protect normal cells from the side effects of chemotherapy. Giving     acetylcysteine together with mannitol, combination chemotherapy, and sodium thiosulfate may     be an effective treatment for malignant brain tumors.      PURPOSE: This phase I trial is studying the side effects and best dose of acetylcysteine when     given together with mannitol, combination chemotherapy, and sodium thiosulfate in treating     children with malignant brain tumors.   "
183013|NCT00238199|"     RATIONALE: Calcitriol may cause pancreatic cancer cells to look more like normal cells, and     to grow and spread more slowly. Drugs used in chemotherapy, such as docetaxel, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Calcitriol may also help docetaxel work better by making the tumor cells     more sensitive to the drug. Giving calcitriol together with docetaxel may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving calcitriol together with docetaxel     works in treating patients with metastatic or locally advanced pancreatic cancer.   "
183014|NCT00238212|"     This phase II trial is studying how well sorafenib works in treating patients with     unresectable or metastatic gallbladder cancer or cholangiocarcinoma. Sorafenib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking     blood flow to the tumor   "
183015|NCT00238225|"     RATIONALE: Calcitriol may cause solid tumor cells to look more like normal cells, and to grow     and spread more slowly. Ketoconazole and dexamethasone may help calcitriol work better by     making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole     and dexamethasone may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of calcitriol when     given together with ketoconazole and dexamethasone in treating patients with metastatic or     unresectable solid tumors.   "
183016|NCT00238238|"     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Biological therapies, such as lenalidomide,     may stimulate the immune system in different ways and stop cancer cells from growing.     Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the     cancer. Giving rituximab together with lenalidomide may kill more cancer cells. This     randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating     patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.   "
183017|NCT00238251|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used     in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving radiation     therapy together with either gefitinib or temozolomide may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well giving radiation therapy     together with either gefitinib or temozolomide works in treating patients with non-small cell     lung cancer and brain metastases.   "
183018|NCT00238264|"     RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may     kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This phase II trial is studying how well radiation therapy works in treating young     patients with gliomas.   "
183125|NCT00238823|"     The purpose of this retrospective study is to describe why and when we used cryo and why we     crossed over when we used both RFA and cryo. It is also to determine if there is some     predictor that would make us say one patient would be better served with one technique than     another and to describe our overall acute success rate and then our 6-month recurrence rate     with cryo ablation and compare it to our known success rate with RFA.   "
183019|NCT00238277|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide during and     after radiation therapy may kill any tumor cells that remain after surgery and placement of     Gliadel wafers.      PURPOSE: This phase II trial is studying how well giving temozolomide during and after     radiation therapy works in treating patients who have undergone previous surgery and     placement of Gliadel wafers for newly diagnosed glioblastoma multiforme.   "
183020|NCT00238290|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Estrogen can cause the growth of     breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the     amount of estrogen the body makes. Giving trastuzumab together with letrozole after disease     progression may be an effective treatment for breast cancer.      PURPOSE: This phase II trial is studying how well giving trastuzumab together with letrozole     works in treating postmenopausal women with progressive advanced breast cancer.   "
183021|NCT00238303|"     This phase II trial is studying how well vorinostat works in treating patients with     progressive or recurrent glioblastoma multiforme. Drugs used in chemotherapy, such as     vorinostat, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.     Giving it after surgery may kill any remaining tumor cells.   "
183022|NCT00238316|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of letrozole may stop cancer from forming or coming back in     postmenopausal women who are at increased risk for breast cancer due to high breast density.      PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing     breast cancer in postmenopausal women who are at increased risk for breast cancer due to high     breast density.   "
183024|NCT00238342|"     RATIONALE: Finding specific proteins in the blood may help doctors tell whether a patient has     ovarian cancer.      PURPOSE: This clinical trial is studying how well proteomic profiling works in diagnosing     ovarian cancer in patients who are undergoing surgery for an abnormal pelvic mass.   "
183025|NCT00238355|"     RATIONALE: Voriconazole and caspofungin acetate may control invasive fungal infections in     patients who have weakened immune systems.      PURPOSE: This phase II trial is studying how well giving voriconazole together with     caspofungin acetate works in treating invasive fungal infections in patients with weakened     immune systems.   "
183026|NCT00238368|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy with an     autologous stem cell or bone marrow transplant may allow more chemotherapy to be given so     that more cancer cells are killed. Procedures, such as fludeoxyglucose F 18 positron emission     tomography (FDG-PET) (done during chemotherapy) may help doctors predict a patient's risk of     relapse and help plan the best treatment.      PURPOSE: This phase II trial is studying how well FDG-PET works in predicting risk of relapse     in patients with aggressive non-Hodgkin's lymphoma who are undergoing combination     chemotherapy with or without autologous stem cell or bone marrow transplant.   "
183027|NCT00238381|"     RATIONALE: Rectal reconstruction after surgery to treat rectal cancer may help patients keep     some of their bowel function. It is not yet known which method of rectal reconstruction is     most effective after surgery.      PURPOSE: This randomized phase III trial is studying three different methods of rectal     reconstruction to compare how well they work in treating patients who are undergoing surgery     for rectal cancer.   "
183028|NCT00238394|"     AZD2171 (cediranib maleate) may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial     is studying how well AZD2171 works in treating patients with locally advanced or metastatic     liver cancer.   "
183029|NCT00238407|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel and     cisplatin may also make tumor cells more sensitive to radiation therapy. Giving docetaxel and     cisplatin together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together     with radiation therapy works in treating patients with locally advanced esophageal cancer     that cannot be removed by surgery.   "
183030|NCT00238420|"     This phase I/II trial is studying the side effects of giving paclitaxel together with     radiation therapy with or without trastuzumab and to see how well it works to kill any     remaining tumor cells in patients who have undergone surgery for bladder cancer. Drugs used     in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive     to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel     together with radiation therapy and trastuzumab may kill more tumor cells. Giving these     treatments after surgery may kill any remaining tumor cells.   "
183031|NCT00238433|"     RATIONALE: Chemotherapy, such as busulfan, melphalan, and thiotepa, may destroy cancerous     blood-forming cells (stem cells) in the blood and bone marrow. Giving the patient their     healthy stem cells will help their bone marrow make new stem cells that become red blood     cells, white blood cells, and platelets.      PURPOSE: This phase II trial is studying how well busulfan, melphalan, and thiotepa work in     treating patients who are undergoing an autologous stem cell transplant for Hodgkin's or     non-Hodgkin's lymphoma.   "
183032|NCT00238446|"     This purpose of this extension study of patients being treated with EC-MPS is to assess the     long term safety of this medication.   "
183033|NCT00238459|"     The purpose of this study is to determine the role of HIV-specific CD4 T cell responses and     immune responses dependent upon these CD4 responses that develop when antiretroviral drugs     are started during acute or recent HIV infection, whether these CD4 responses can be enhanced     with a therapeutic HIV vaccine (HIV-1 immunogen), and what pattern of HIV-specific immune     responses is associated with control of HIV upon discontinuation of antiretroviral drugs     during an analytical therapeutic interruption. Participants will be treatment-naive adults     with acute or early HIV infection who will choose to start or not start anti-HIV drugs at the     beginning of the study. NOTE: In August 2007 we were notified by the manufacturer of the     candidate vaccine that they were no longer making the vaccine, and that the vaccine would no     longer be available. Unfortunately too few participants have received either the vaccine or     placebo to conclude anything about efficacy. No safety problems occurred.   "
183034|NCT00238472|"     This study is not being conducted in the United States. The purpose of the study is to     evaluate the effects of nateglinide compared to glibenclamide on renal hemodynamics and     albumin excretion.   "
183035|NCT00238485|"     This extension study is designed to investigate the long-term safety and tolerability of     licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind     study CLIC477D2302.   "
183036|NCT00238498|"     This study was not conducted in the United States. The purpose of this study was to assess     the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the     treatment of people with type 2 diabetes.   "
183037|NCT00238511|"     This trial was the follow-on trial to a preceeding double-blind, placebo controlled trial     which included patients with at least moderate pain due to postherpetic neuralgia. It was     conducted at six sites in Germany and has been clinically finalized. The patients had     successfully completed the above mentioned trial in postherpetic neuralgia and, in the     investigator's opinion, would benefit from long-term administration of Lacosamide. After a     1-week run-in phase the patients were uptitrated to their optimal dose and then continued     into the maintenance phase. Dose adjustments were allowed throughout the trial.The change in     pain was measured daily as well as interference of pain with sleep and general activity. As     per protocol this trial was terminated after two years of treatment.   "
183038|NCT00238524|"     This trial was conducted at about 50 sites in Europe and has been clinically completed.     Patients had symptoms of painful diabetic neuropathy for 6 months up to 5 years with an     optimized diabetic control and at least moderate pain. Patients were not eligible with other     chronic pain or any other medical or psychiatric condition, that would have jeopardized or     compromised the patient's ability to participate in the trial. After a 2-week run-in phase     patients were randomly assigned to one of three treatment arms. All patients who had     completed the 6-week titration phase to reach their target dose entered a 12-week maintenance     phase. At the end of the maintenance phase, subjects were offered the option of entering the     open-label, follow-on trial. The change in pain was measured daily as well as interference of     pain with sleep and general activity.   "
183039|NCT00238537|"     To determine whether the extent of the ischemic penumbra apparent on perfusion-diffusion MRI     can be used to identify patients who would respond positively and safely to tissue     plasminogen activator (tPA) beyond 3 hours post-stroke.   "
183040|NCT00232141|"     Study to determine if pregabalin is more effective than placebo in treating subjects with     nerve pain associated with HIV neuropathy.   "
183041|NCT00232154|"     To measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg     tablets for up to 3 days.   "
183042|NCT00232167|"     The goal of this study is to determine whether indiplon, when administered with sertraline,     improves insomnia symptoms and depressive symptoms in subjects with both insomnia and     depression.   "
183043|NCT00232180|"     In an earlier study, eplerenone was shown to improve survival in patients who had heart     failure immediately following a heart attack. However, it is not known how patients with     established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of     sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus     standard heart failure medicines is being compared to placebo plus standard heart failure     medicines in terms of an additional ability to prolong life and prevent re-hospitalizations     for worsening heart failure in these patients.      The Data Safety Monitoring Committee (DSMC) observed during its conduct of the     protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of     eplerenone had met the pre-specified stopping rules in the protocol. As a result of the     discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended     that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration     that it would be unethical not to offer this treatment to patients, the ESC recommended that     all the patients in the trial should be transferred to open-label eplerenone. The Open Label     Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for     the indication studied in this patient population.      On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered     to be the most appropriate way to ensure that all the subjects who participated in the     double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone   "
183044|NCT00232193|"     The purpose of the study is to determine whether giving intravenous dexamethasone every 4     weeks during the first 12 months of weekly Avonex dosing will reduce the progression of     functional impairment, brain atrophy, relapse rate and frequency, and new and enlarging brain     lesions over the first 24 months of Avonex therapy in patients with relapsing-remitting or     mono-symptomatic multiple sclerosis.   "
185350|NCT00269841|"     The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric     monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing     Crohn's disease.   "
183045|NCT00232206|"     The primary objective of this study is to assess the response rate of treatment with two     cycles of cisplatin and docetaxel chemotherapy prior to surgery (neoadjuvant) for early stage     non-small cell lung cancer (NSCLC). Secondary objectives of this study include assessment of     radiographic response rate by computed tomography (CT) scanning, overall survival, time to     progression, rate of complete surgical removal, and adverse reactions. In addition, this     study will test whether positron emission tomography (PET) imaging can predict a tumor     response. Patients who have a response to chemotherapy may receive 2 additional cycles after     recovering from surgery.   "
183046|NCT00232219|"     The purpose of this study is to investigate whether fish oil supplements may be beneficial in     preventing the recurrence of atrial fibrillation after cardioversion.      Atrial fibrillation is a heart condition which can sometimes be successfully treated by a     cardioversion.      Cardioversion involves resetting the heart back to normal with the use of electric current.      There is a tendency for the atrial fibrillation to recur , days weeks or even months after     the cardioversion.      Fish oil supplements may be of benefit to patients with heart problems Recent evidence     suggests that fish oils may be beneficial to patients with rhythm disturbances.   "
183047|NCT00232232|"     The purpose of this study is to investigate whether fish oils may be of benefit to patients     with certain heart rhythm disturbances called atrial fibrillation and atrial flutter.      Atrial fibrillation and atrial flutter are two heart conditions that can be successfully     treated in the hospital by an ablation (in the case of atrial flutter) or a cardioversion (in     the case of atrial fibrillation). Ablation involves the application of high frequency energy     waves to a particular spot in the heart. Cardioversion involves resetting the heart back to a     normal rhythm with the use of an electric current.      Fish oil supplements may be of benefit to patients with heart problems. Recent evidence     suggests that fish oils may benefit those with rhythm disturbances.   "
183048|NCT00232245|"     The purpose of this study is to investigate whether fish oil supplements may reduce the     frequency and duration of paroxysmal atrial fibrillation episodes.      Atrial fibrillation is a heart condition which effects a large percentage of the population .      Atrial fibrillation is a condition frequently experienced by people who have had pacemakers     inserted .      Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes     of atrial fibrillation.      Fish oil supplements may be of benefit to patients with heart problems.Recent evidence     suggests that fish oils may be beneficial to patients with rhythm disturbances.      By interrogating pacemakers this study will investigate the effect of fish oil supplements on     the frequency and duration of episodes of atrial fibrillation.   "
183049|NCT00232258|"     To evaluate the safety and efficacy on clinical symptoms, mucosal histology and endoscopic     mucosal appearance of two doses of SR140333B against placebo in patients with mild to     moderate ulcerative colitis resistant to treatment with 5-ASA.   "
183050|NCT00232271|"     The purpose of this study is to assess the effect of the anticoagulant(blood thinner) Clexane     on the development of leg clots following electrophysiology studies (EPS) and or     radiofrequency ablation (RFA).      People who suffer heart palpitations will sometimes need hospital admission to undergo an     electrophysiology study ( and or a Radiofrequency Ablation)in order to diagnose and or treat     their condition.      Radiofrequency ablation is a procedure to stop abnormal heart rhythms. EPS/RFA studies     require the puncture of the leg veins . Previous experience has shown that following the     puncture of leg veins there is a small risk of developing a blood clot in the leg.      It is not known whether giving blood thinners (anticoagulants) after the procedure will     decrease this risk Enoxaparin Sodium (Clexane) is an anticoagulant used extensively and     safely following bone (Orthopaedic) surgery to prevent blood clots from developing in the     legs   "
183051|NCT00232284|"     This study aims to treat young people with an adjunctive integrated cognitive behavioral     therapy (CBT) intervention and to examine the acceptability of this treatment approach within     this population. The study will also include a pilot placebo-controlled trial of sertraline     for those young people who fail to or only partially respond to the CBT intervention, so as     to determine whether adjunctive anti-depressant treatment improves clinical response in this     population.   "
183052|NCT00232297|"     Primary objective:        -  to assess the efficacy of SSR149744C for the prevention of ventricular          arrhythmia-triggered ICD interventions.      Secondary objectives:        -  to assess versus placebo the tolerability of the different dose regimens of SSR149744C          in the selected population.        -  to document SSR149744C plasma level during the study.   "
183053|NCT00232310|"     Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of     atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical     cardioversion.   "
183054|NCT00232323|"     The purpose of the study is to check wether training mixed teams of physicians and nurses     from intensive care units on patient simulators reduces stress in team members.   "
183055|NCT00232336|"     The purpose of this study was to collect pilot data on whether quetiapine may be effective in     the reduction of cocaine use and cravings in cocaine dependent individuals.   "
183056|NCT00232349|"     The purpose of this study was to determine if treatment with adjunctive galantamine is     effective in the reduction of functional impairments in patients with schizophrenia and     schizoaffective disorder. It was hypothesized that adjunctive galantamine would yield     clinically significant improvements from baseline to end of study on a measure of quality of     life and a measure of independent living skills.   "
183057|NCT00232362|"     This study is being done to determine if pioglitazone (Actos) is helpful to patients with     type 2 diabetes and could possibly prevent harmful consequences of cardiovascular disease in     diabetic patients.   "
183058|NCT00232375|"     We tested the hypothesis that insulin therapy rather than sulfonylurea (SU) treatment has a     preferable outcome to reverse or preserve beta cell function in the patients with diabetes     that is called slowly progressive insulin-dependent (type 1) diabetes (SPIDDM) or latent     autoimmune diabetes in adult (LADA).   "
183059|NCT00232388|"     The purpose of this study is to determine if the carboxy-terminal of procollagen type I     (PICP) can be a useful marker of different degrees of myocardial fibrosis.   "
183060|NCT00232401|"     The purpose of this study is to describe the 24-hour urine output including the urinary     excretion of hormones, electrolytes and other osmotically active substances in healthy     children age 0 to 3 years old.   "
183061|NCT00232414|"     In this study, quetiapine is being tested for the possible treatment of bipolar I disorder     with an acute depressive episode in children and adolescents.      We hypothesize that quetiapine will be more efficacious than placebo for the treatment of     episodes of major depression associated with adolescent BP. Moreover, we hypothesize that     quetiapine will be safe and well-tolerated compared with placebo for the treatment of     depression associated with adolescent BP. Based on data from the BOLDER study and other     studies of atypical antipsychotics in patients with bipolar depression (Calabrese et al.,     2004, Macfadden et al., 2004, Tohen et al., 2004), which in general reveal effect sizes of     approximately 0.5, a conservative sample size calculation, assuming power of .8, estimates we     would need approximately 15 patients in each group to identify a statistically significant     group difference in our main outcome measure, change form baseline to endpoint in the     Children's Depression Rating Scale (Poznanski, 1979).   "
183062|NCT00232427|"     Prospective comparison of standard therapy in liver cirrhosis versus standard therapy plus     intensified hemodynamic monitoring using the PiCCO system.   "
183063|NCT00232440|"     Radiation therapy has a well-established role in the treatment of Hodgkin's Disease and     non-Hodgkin's Lymphoma. With technological developments, 3-D Dimensional (3D) planning has     evolved as a highly precise treatment planning option. High-precision radiation therapy has     the potential for more accurate dose delivery to the tumour volume and can result in a     greater sparing of normal tissue. An important component of safe radiotherapy delivery is the     feasibility and reproducibility of current and new immobilization devices for highly     conformal treatment.      The purpose of this study is to determine the reproducibility of an immobilization device     known as BodyFIX(TM) using conventional treatment techniques.   "
183064|NCT00232453|"     There is no established standard preoperative treatment in rectal cancer. Two large     randomized studies in North America closed from lack of accrual; therefore the only method of     assessing preoperative treatment in rectal cancer is from Phase II studies. This study builds     on the experience at PMH gained in two previous studies which demonstrated a lower than     expected toxicity with concurrent 5FU infusion and external radiotherapy. The current     standard at PMH is preoperative radiation, 46Gy in 23 fractions with concurrent 5FU infusion     225mg/m2. An increase of radiation dose and consequent increase in chemotherapy may improve     the response rate, but may also increase toxicity. It is proposed to increase the dose of     radiotherapy to 50Gy in 25 fractions with concurrent chemotherapy and measure acute toxicity     and complete remission rate.   "
183074|NCT00232583|"     The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic     patients on two different treatment regimens: insulin and metformin versus glyburide,     metformin and pioglitazone.   "
183065|NCT00232466|"     Percutaneous vertebroplasty is a new procedure for treating painful osteoporotic compression     fractures of the spine. Five-thousand out of 12.000 patients (16.000 vertebral fractures/year     in the Netherlands) present with sudden, severe back pain in the region of the fracture.Until     recently, bed rest, analgesia and physical support were the only treatment options. After     decades of performing PV, no large RCT with mid-term follow-up has been published.      Design:      This will be a multicenter (6 centers), prospective, randomised, intervention study. Eligible     patients will be randomised for percutaneous vertebroplasty or conservative therapy.      Study population:      Age: 50 and older, vertebral fracture, level: thoracic vertebral body 5 (Th 5) or lower,     osteopenia (T-score &lt; -1 SD), back pain for no more than 6 weeks and edema in the     vertebrae on MR imaging      Statistical analyses All analyses will be performed on an 'intention to treat' principle. The     planned number of subjects will be 200 in total, 100 in each intervention arm.      Economic evaluation:      Cost-effectiveness will be assessed. The costs of the procedure and the medical treatment,     and of visits to medical specialists, GP's and physical therapists will be compared.      Time schedule:      The total study will take 36 months      Recruitment of patients (200) has been completed. In May 2009 the 1 year follow-up will be     finished.   "
183066|NCT00232479|"     Dose dense therapy has been shown to increase survival in the adjuvant setting of breast     cancer. It is unknown if dose dense therapy will improve survival in tumors that express     her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and     herceptin when used in a dose dense manner in patients with large breast cancers. The     endpoint of pathologic complete response is used as a surrogate marker for survival.   "
183067|NCT00232492|"     The purpose of the study is to determine whether equal subanesthetic doses of racemic     ketamine is equally effective on females and males after surgical removal of third molars   "
183068|NCT00232505|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. It is not yet known whether     giving cetuximab together with carboplatin is more effective than giving cetuximab alone in     treating metastatic breast cancer.      PURPOSE: This randomized phase II trial is studying cetuximab and carboplatin to see how well     they work compared with cetuximab alone in treating women with estrogen receptor-negative     (ER-), progesterone receptor-negative (PR-) metastatic breast cancer.   "
183084|NCT00232713|"     The Uterine Fibroid Pregnancy Registry is a USA and European-based registry designed to     monitor pregnancies in women with uterine fibroids in order to        1. estimate the risk ratio of birth defects in women with uterine fibroids who were treated          or untreated during pregnancy and        2. detect any pattern of birth defects among pregnancies in specific treatment groups.      Those pregnant women exposed to various therapies used to treat uterine fibroids will be     compared with those not exposed to treatment in order to detect any potential increase in the     risk of major birth defects.   "
183085|NCT00232726|"     Previously untreated patients with malignant melanoma receive a new chemotherapy drug     currently under development. CP-4055 is given intravenously on days 1-5 every four weeks     until complete response or disease progression.   "
183086|NCT00232739|"     The main objective of this study is to assess the safety and effectiveness of the     sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de     novo native coronary artery lesions.   "
183087|NCT00232752|"     The main objective of this study is to assess the safety and effectiveness of the     sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss in patients with de     novo native coronary artery lesions.   "
183069|NCT00232518|"     There has been considerable debate over the last 30 years about the interaction between     asthma and parasitic infection. It has been suggested that at least part of the reason for     the increasing prevalence of asthma in the developed world is a decrease in parasite     infections resulting from improved living conditions with economic development. Our previous     studies in Ethiopia suggest that hookworm infection may be particularly important in this     process.      To establish definitively whether parasites can protect against allergic disease, and     specifically asthma, ultimately requires a randomised clinical trial of parasite infection in     patients with asthma. We, the researchers at the University of Nottingham, have completed a     study in normal volunteers to establish the dose of hookworms necessary to generate infection     at the level shown to be protective in population surveys, and shown that infection is well     tolerated. We now propose two randomised placebo-controlled double blind clinical trials. The     first will test the effectiveness of hookworm infection in reducing symptoms in allergic     patients with rhinitis, and will also serve to allow us to check the likely safety of     hookworm infection in asthma. Assuming that the results of this study are favourable, we will     then carry out a trial of hookworm infection in asthma. We will also take the opportunity     during both of these studies to investigate the cellular mechanisms of the effect of hookworm     infection on the immune system.   "
183070|NCT00232531|"     AIM 1 will test the hypothesis that elevation of high-density lipoprotein (HDL) through     treatment with Niaspan will accelerate the regression of atherosclerotic plaque in patients     with established atherosclerosis. The investigators will therefore study patients with     atherosclerosis in the aorta and carotid artery. Plaque quantification will be with magnetic     resonance imaging (MRI).      AIM 2 will assess the ability of Niaspan to improve endothelial function in patients with     coronary artery disease and type II diabetes mellitus, who typically have low high-density     lipoprotein cholesterol (HDL-C), and high risk of cardiovascular events.   "
183071|NCT00232544|"     This study is investigating the effects of a telecommunications system designed to improve     patient adherence with prescribed positive airway pressure (CPAP).   "
183072|NCT00232557|"     This project is investigating whether application of a telecommunications system to the care     of adult patients with asthma will improve self-management by enhancing compliance with     preventive medication regimens and fostering the use of peak-flow-based action plans.   "
183073|NCT00232570|"     The primary hypothesis is that quetiapine will improve sleep in persons with Alzheimer's     Disease (AD), with higher doses producing greater total sleep time and sleep efficiency.   "
183075|NCT00232596|"     This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed     at 1200 mg/day, in three equally divided doses, compared with placebo in patients with     epilepsy who are receiving up to three established antiepileptic drugs (AEDs).   "
183076|NCT00232609|"     The purpose of this research project is to further develop and test the effectiveness of a     novel exercise system for wheelchair users, the Game Cycle.   "
183077|NCT00232622|"     The optimal dosage and duration of administration of clot-dissolving medications for the     treatment of patients with mechanical heart valves with clots is not known. We hypothesized     that a large dose of the clot-dissolving medicine given initially (akin to the dose given in     the treatment of heart attacks), might speed up the dissolution of the clot and rapidly     restore the functioning of the mechanical heart valve.   "
183078|NCT00232635|"     Objectives      Primary Objectives:        -  Pilot Study: A preliminary assessment of the exposure and safety of oral A-60444 in          post-stem cell transplant patients with RSV infection.        -  Main Study: To determine the antiviral effect of oral A-60444 versus placebo in          post-stem cell transplant patients with RSV infection and to assess the safety of oral          A-60444 in post-stem cell transplant patients with RSV infection.      Secondary Objectives:        -  To study the pharmacokinetics of A-60444 in the presence of concomitant medications such          as immunosuppressants and antifungals, in post-stem cell transplant patients with RSV          infection.      Sample Size: Six patients will be included in the open, pilot phase of the study and there is     an option to include a further 22 patients into the main, placebo-controlled study, depending     on the pilot study findings. An independent Data Safety Monitoring Board will assess the     findings of the pilot study.   "
183079|NCT00232648|"     This study is as an extension study of SD-004-0765, to assess the safety profile of long-term     use of budesonide inhalation suspension in Japanese young children with bronchial asthma.     Children completing study SD-004-0765 continued administration of budesonide inhalation     suspension as judged by the investigator; the dose is adjusted as appropriate within the     range of 0.25 to 1.0 mg per day administered once or twice daily, according to the symptoms.   "
183080|NCT00232661|"     The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which     we already know to be well tolerated. The main objectives of this research study are to see     whether using these drugs will shrink down tumours before surgery and to see if any shrinkage     in the tumour affects the extent of surgery that is required.   "
183081|NCT00232674|"     To assess the effect of up to 4 years treatment with budesonide on progression of emphysema     in patients with Chronic Obstructive Lung Disease.   "
183082|NCT00232687|"     The purpose of this clinical research study is to evaluate the safety and tolerability of two     switching strategies from risperidone to aripiprazole over a period of 12 weeks in     out-patients who are treated in a general psychiatric practice setting and who are currently     experiencing efficacy and/or safety/tolerability issues while on risperidone.   "
183083|NCT00232700|"     We intend to test in a randomized, rater blinded, placebo controlled, prospective study the     primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the     treatment of refractory major depression assessed with the Hamilton Depression Rating Scale   "
183088|NCT00232765|"     The main objective of this study is to assess the safety and effectiveness of the     sirolimus-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native     coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent.     Both stents are mounted on the Raptorâ over-the-wire (OTW) Stent Delivery System.   "
183089|NCT00232778|"     The objectives of this study are:        1. To show a reduction in the late thrombosis (LT) rate following percutaneous          revascularization using current interventional techniques with new stent placement and          intravascular radiation therapy (IRT) with a long-term antiplatelet regimen (12 months)          compared to the stented patients on short-term antiplatelet regimen (2 months) from the          IRT arm of GAMMA I Trial.        2. To show equivalence in the LT rate following percutaneous revascularization using          current interventional techniques without new stent placement and IRT with a long-term          antiplatelet regimen (6 months) compared to non-stented patients on short term          antiplatelet therapy (2 months or less) from a pooling of the IRT arms of the GAMMA I,          SCRIPPS, and WRIST Trials.   "
183090|NCT00232791|"     The main objective of this study is to assess the safety and effectiveness of the CYPHER     SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de     novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.   "
183091|NCT00232804|"     The objective of this study is to establish the safety and efficacy of the treatment with     Cypher DES in diabetic patients with documented ischemia due to stenosis (small coronary     artery 2.5 -3 mm in lumen diameter, with lesion between 15 mm 30 mm in length, ) in native     coronary arteries.      The objective of this study is to document that the use of Cypher DES in these diabetic     patients undergoing percutaneous revascularization for stenosis is safe.      Safety will be assessed over a period of 12 months.   "
183092|NCT00232817|"     The purpose of this study is to compare post-operative pain after anesthesia with either     isoflurane or propofol. Each group will be further randomized to recieve intranasal nicotine     or placebo inorder to detect potetial pronociceptive action of isoflurane.      The study is a randomized, prospective, double-blinded controlled trial. Eighty adult women     undergoing uterine surgery will be recruited for this study. Enrollment in this study is     limited to women, because our animal studies suggest that females have a greater hyperalgesic     response to volatile anesthetics than do males.      The patient will be given one of two standard anesthetics for their surgery: isoflurane or     propofol. We are interested in these two anesthetics because we seek to see if there exists a     difference in their effects on a patient's perception of pain, as has been shown to be the     case in animal studies but has not yet been studied in humans.      The primary outcome variable will be postoperative pain, as measured by a numerical analog     pain score (VAS) at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 120, and 1440 minutes     postoperatively. Secondary outcome measures will include morphine utilization via PCA and     hemodynamics variables including heart rate, systolic BP, and diastolic BP, all of which will     be measured at the same time points as the VAS score.   "
183093|NCT00232830|"     The main objective of this study is to assess the effectiveness and safety of the CYPHER™     (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint     of target vessel failure (TVF) in subjects treated for acute myocardial infarction as     compared to a bare metal stent.   "
183094|NCT00232843|"     The main objective of this study is to assess the performance of the Cordis SMART™ nitinol     self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in     comparison with balloon angioplasty only as determined by binary restenosis at one year.   "
183095|NCT00232856|"     The main objective of this study is to assess the safety and effectiveness of the Cypher™     sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an     in-stent restenotic native coronary artery lesion.   "
183096|NCT00232869|"     The main objective of this study is to assess the safety and performance of the sirolimus     coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the     treatment of obstructive superficial femoral artery (SFA) disease in reducing percent     in-stent mean lumen diameter stenosis in de novo or restenotic native lesions as compared to     the uncoated SMART™ stent.   "
183097|NCT00232882|"     Angiotensin receptor antagonists (ARA), beta-blockers and diuretics do not seem to confer     equivalent cardiovascular protection in hard outcomes clinical trials (beta blockers     inferior). These results may be explained by differences in their effects on sympathetic     activity, oxidative stress, inflammation and renin angiotensin system activation.      How diuretic addition to first line therapy with ARAs and beta-blockers modulates     neurohumoral and hemodynamic parameters is not well understood.      The main hypothesis of this study is that an ARA (candesartan) combined or not with a     diuretic will not increase sympathetic activity as much as a beta blocker (atenolol).     Secondary hypothesis are of similar nature but relate to hemodynamic parameters, oxidative     stress markers, inflammatory markers, or the renin angiotensin system.      The main objective of this study is to assess and compare the effects of candesartan and     atenolol and their combination with low dose diuretic therapy on the autonomic nervous     system, hemodynamic parameters,on oxidative stress, on inflammatory markers, and on the     renin-angiotensin system.      Protocol sponsored by Astra Zeneca canada   "
183098|NCT00232895|"     Randomised controlled trial of pain of injection of lipuro in children age 1-7 versus the     pain of injection of the standard formulation   "
183099|NCT00232908|"     This study will evaluate patient quality of life and tolerability of a HAART (highly active     antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in     clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use     a 31-gauge thin-walled 8mm needle to administer Fuzeon. The anticipated time on study     treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
183100|NCT00232921|"     Radiological study into the anatomical spread of caudal local anaesthetic in children age 1-7   "
183101|NCT00232934|"     The purpose of this study is to determine whether the association of Thalidomide to Melphalan     and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.   "
183102|NCT00232947|"     The goal of this study is to determine whether the immune responses induced by Fluviral, the     investigational vaccine, are comparable to those induced by Fluzone, which is an influenza     vaccine currently licensed in the U.S. The study focuses on persons 50 years old and over. In     addition, the study will compare the rate of reactions to the two vaccines, and the general     health of persons who receive them over the 42 days after immunization.   "
183122|NCT00238784|"     The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best     Conventional Practice in patients with persistent asthma   "
183103|NCT00232960|"     There is no consensus on the indication of postoperative radiotherapy for early stages oral     and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck     node metastasis, but most of the institutions do not give any post-operative treatment.     Loco-regional control rates range between 80-85% at five years. Surgical margins molecular     analysis for microsatellite instability (MSI) marker could help to select the high-risk     patients who should receive postoperative radiotherapy. We expect to include 120 patients in     five years and have 60 informative tumors for MSI marker. Patients with positive molecular     margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular     margins will not receive radiotherapy.   "
183104|NCT00232973|"     The main purpose of the study is to compare treatment of non-infected venous leg ulcers using     ICXP007 combined with four-layer compression bandaging, placebo combined with four-layer     compression bandaging and four-layer compression bandaging alone.   "
183105|NCT00232986|"     The goal of this study is to use three different survey methodologies to evaluate whether     adolescents report on their knowledge, attitudes and behaviors on sexual and reproductive     health issues differently based on the manner in which questions are asked.   "
183106|NCT00238550|"     The study is designed to investigate the benefit of adding CBME to the existing treatment     regime in the management of painful neuropathy.      Hypothesis:        1. The addition of CBME to the existing treatment regime will result in a significant          improvement in both primary and secondary outcome measures.        2. The side effect profile and tolerability of CBME will be minimal and comparable to          placebo.   "
183107|NCT00238563|"     Determine efficacy of sub tenon kenalog injections for post-operative management of     trabeculectomy procedures.   "
183108|NCT00238576|"     This project will expand current knowledge of reproductive biology in women with bipolar     disorder as well as assessing the impact of lamotrigine use for the treatment of bipolar     disorder on reproductive function. Specifically, this study examines mood over the menstrual     cycle and ovulation for three consecutive menstrual cycles in women treated for bipolar I,     II, or NOS (not otherwise specified) with lamotrigine. In addition, testosterone and lipid     concentrations will be measured before the participant starts receiving lamotrigine, as well     as six months after receiving lamotrigine.   "
183109|NCT00238602|"     This study has two primary objectives. The first objective is to determine the maximal     tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with     inoperable malignant lung tumors. Once the MTD is established, the second objective is to     determine the efficacy of radiosurgical ablation of lung tumors in terms of symptoms and     radiographic responses.   "
183110|NCT00238615|"     The purpose of this study is to assess how well this particular combination of chemotherapy,     radiation and surgery works to help people with locally advanced lung cancer, how well PET     scans indicates whether someone has responded to chemotherapy and radiation, and gene     expression patterns related to outcomes in patients with locally advanced lung cancer who     receive this treatment regimen.   "
183111|NCT00238628|"     The purpose of Phase 1 of this study is to evaluate the safety of the combination regimen,     bexarotene and ZD1839. Phase II will evaluate the median survival, time to disease     progression, and toxicity.   "
183112|NCT00238641|"     In children with cerebral palsy, stiffness of the arm can develop early and delay or prevent     the acquisition of normal hand skills. Improvement in functional use of the hand may     therefore be dependent upon early treatment of upper extremity hypertonia. We propose to test     a series of injections of Myobloc™ in a non-randomized one-way crossover pilot clinical trial     and dose-finding study, with clinical assessments and blinded video evaluations. Ten children     age 2-17 years with increased tone at the elbow or wrist will be expected to complete the     study. A 1-month baseline evaluation period will be followed by an injection of low-dose     Myobloc™ to affected muscle(s) of the arm according to standardized per-kilogram dosing with     a maximum of 25U/kg in each affected arm. Three months later, a second injection of up to     50U/kg will be performed in each affected arm. Three months after the second dose, a third     dose of up to 100U/kg will be performed in each affected arm. Neurological assessments will     be performed at study entry, prior to each injection, and at 1 and 3 months following each     injection. Routine physical therapy and non-study medications will be continued during the     study.   "
183113|NCT00238654|"     This study has patients responding to two sets of surveys that will tell their doctor or     nurse about their readiness to begin self-injection. In addition, patients will have their     self-injection observed and evaluated on up to three visits   "
183114|NCT00238667|"     This is a feasibility study to determine if a sufficient number of patients can be recruited     throughout the United Kingdom and whether sufficient endpoints can be generated for a full     scale therapeutic trial of anticoagulants versus antiplatelets in acute cervical artery     dissection treatment.   "
183115|NCT00238680|"     The purpose of this study is to evaluate the effect of bladder rehabilitation in a     non-selected group of children with idiopathic overactive bladder and to clarify whether the     effect of the treatment can be increased by addition of a programmable timer   "
183116|NCT00238693|"     This is a registry of data collected from patient records, both of those who have a condition     which may require transplantation and those who have undergone transplantation of the liver,     kidney and/or pancreas.   "
183117|NCT00238706|"     The aim of this prospective randomized clinical trial was to evaluate the early and late     outcome following left atrial radiofrequency ablation during MV surgery for the treatment of     continuous atrial fibrillation and to assess the functional effects of restoration of sinus     rhythm.   "
183118|NCT00238719|"     To determine the anxiolytic efficacy, safety, and tolerability of a flexible-dose of     venlafaxine extended release (ER) administered for 16 weeks in the treatment of children and     adolescent outpatients with social anxiety disorder (generalized) in a placebo-controlled     study.   "
183119|NCT00238732|"     The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are     effective in the treatment of vaginal atrophy.   "
183120|NCT00238745|"     Dose-response in Japanese patients with postmenopausal osteoporosis.   "
183121|NCT00238758|"     The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are     effective as a monotherapy for depression.   "
183126|NCT00238836|"     The University of Ottawa and Élisabeth Bruyère Research Institute are conducting a study of     preventive care for frail patients at risk of functional decline. At risk patients are     assigned by chance to continue receiving their standard care from their family physician or     receive additional care from a nurse practitioners and a pharmacist. In collaboration with     the family physician, they develop an individualized care plan, a treatment and management     road plan, for each patient, which they implement over the study period of one approximately     year. The objective of the study is to compare the effectiveness of the model of care that     includes the nurse practitioners and pharmacist against standard care in preventing     functional decline, to determine the acceptability of this model of care to patients, their     caregivers and the medical team, and to evaluate the cost implication of the program.   "
183127|NCT00238849|"     The purpose of this study is to determine the response rate to treatment with oxaliplatin and     Navelbine in patients with previously treated NSCLC. Oxaliplatin and Navelbine have not been     clinically evaluated yet. However, Navelbine has been safely administered with other platinum     compounds.   "
183128|NCT00238862|"     Patients with persistent corneal epithelial defects who have not responded to conventional     therapy will be randomized to treatment with either amniotic membrane transplantation or     autologous serum 20%. Outcome measures will be (1) presence or absence of complete     re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90     days.   "
183129|NCT00238875|"     To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer   "
183130|NCT00238888|"     The objectives of this trials are to demonstrate, in children with poorly controlled asthma,     that an intervention to increase the awareness and the impact of poor asthma control among     parents and physicians of affected children and adolescents can reduce the rate of asthma     emergency visits in the 12 months following the initiation of the intervention.   "
183131|NCT00238901|"     The natural history of HCV infection in liver transplant recipients may be accelerated when     compared to that in patients with normal immune systems.      The objective of this trial is to assess the efficacy and safety of basiliximab, in     combination with cyclosporin and MMF on the success rate of liver transplants for HCV related     cirrhosis, in comparison with standard steroid treatment.   "
183132|NCT00240461|"     Seniors are a population vulnerable to respiratory infections. It is hypothesized that     regular use of COLD-fX following an influenza vaccination would potentially augment immune     response in the elderly. Use of COLD-fX may also provide additional protection again     respiratory infection and reduce the incidence and severity of respiratory infections in     otherwise healthy seniors.   "
183133|NCT00240474|"     The primary objective of this study was test non-inferiority of telmisartan 80 mg +     hydrochlorothiazide (HCTZ) 12.5 mg in comparison to amlodipine 10 mg + HCTZ 12.5 mg in     reducing ambulatory systolic blood pressure (SBP) in the last 6 hours of the 24-hour dosing     interval (determined by ambulatory blood pressure monitoring: ABPM) in elderly patients with     predominantly systolic hypertension.   "
183134|NCT00240487|"     This research project is an open-label, randomized study for the use of Nitric Oxide in     pediatric patients with acute respiratory distress syndrome (ARDS). The study examines     whether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure of     oxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goal     of the study is to evaluate whether the order of NO therapy will have any effect on response,     and evaluate the characteristics of patients who respond to NO compared to those who do not.   "
183135|NCT00240500|"     The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen     (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of     the study vaccine. The Protocol Posting has been updated in order to comply with the FDA     Amendment Act, Sep 2007.   "
183136|NCT00240513|"     The use of oral antibiotics alone to treat inflammatory acne provides little to no long term     therapeutic benefit.      Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with     minocycline, thereby increasing the therapeutic effect of the oral antibiotic.   "
183137|NCT00240526|"     To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after     administration of the first dose of the study vaccine. The Protocol Posting has been updated     in order to comply with the FDA Amendment Act, Sep 2007.      No additional subjects will be recruited during this long-term follow-up study and no vaccine     will be administered.   "
183138|NCT00240539|"     This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs)     antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the     study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up     study.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
183139|NCT00240552|"     This open-label study will enable HIV-infected adults with limited treatment options to     receive fosamprenavir until commercial supplies are available in Switzerland.   "
183140|NCT00240565|"     This study will further characterize the activity of Tositumomab and Iodine I 131-Tositumomab     in patients with relapsed indolent non-Hodgkin's Lymphoma who have progressed following     treatment with rituximab.   "
183141|NCT00240578|"     This is a multi-center study for the long-term follow-up of surviving patients who are     expected to complete or who have completed at least two years of follow-up after treatment     with Iodine I 131 Tositumomab (BEXXAR) on Studies CP-97-011, CP-98-025, CP-99-032, or     CP-99-036. All patients will be assessed for survival and disease status, including     subsequent therapy for NHL, and for long-term safety. Additionally Laboratory evaluations     consisting of a TSH level and a complete blood cell (CBC) count with a differential and     platelet count will be obtained annually. Additionally, patients who remain in long-term     response following Iodine I 131 Tositumomab treatment will be followed for response and     progression.   "
183159|NCT00240812|"     The purpose of the study is to determine if ibuprofen in combination with pseudoephedrine HCl     in the treatment of nightime bedwetting in children is more effective than each drug alone     and if the individual drugs are more effective than placebo.   "
183160|NCT00240825|"     The purpose of this study is to determine the onset of pain relief from a single dose of     acetaminophen and ibuprofen in subjects experiencing postoperative dental pain following the     surgical extraction of at least three molars.   "
183142|NCT00240591|"     This is a study for the long-term follow-up of patients who completed at least two years of     follow-up after treatment with Tositumomab and/or Iodine I 131 Tositumomab (BEXXAR)on Study     RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004 or CP-97-012. All patients will be assessed for     survival and disease status, including subsequent therapy for NHL, and for long term safety.     Laboratory evaluations consisting of a TSH level (for all patients) and a complete blood cell     (CBC) count with a differential and platelet count (for patients in continuing response only)     will be obtained annually through Year 10 post treatment with Tositumomab and/or Iodine I 131     Tositumomab.      Patients that remain in response to their previous treatment with BEXXAR, will additionally     be followed radiographically for response and progression.   "
183143|NCT00240604|"     Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim     of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent     glucose intolerance in patients treated with corticosteroids.   "
183144|NCT00240617|"     The purpose of this study is to determine the consistency of response for Treximet (formerly     known as Trexima) when treating four acute migraine attacks at the mild pain phase and within     1 hour of onset of head pain.   "
183145|NCT00240630|"     The purpose of this study is to determine the consistency of response for Treximet     (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine     attacks at the mild pain phase and within 1 hour of onset of head pain.   "
183146|NCT00240643|"     This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323     in a relevant population. The data from this study will be used along with other data to aid     in choosing the most appropriate dose for the later phase study.   "
183147|NCT00240656|"     The purpose of this study is to determine whether a larger dose of the aldosterone antagonist     spironolactone combined with an ACE inhibitor (captopril) and a beta-blocker (carvedilol) is     effective in reverse pulmonary artery remodeling in patients with pulmonary arterial     hypertension (PAH)secondary to congenital heart disease   "
183170|NCT00240968|"     The purpose of this study is to determine whether a third dose of vaccines containing     A/Vietnam/1203/04 provides more immunity than two doses. Subjects who participate in this     study will have participated in DMID protocol 04-063 involving the A/Vietnam/1203/04. In this     study, each subject will be asked to receive a third dose of the H5 vaccine at the same level     administered in protocol 04-063. Subjects will be asked to record oral temperature and any     experienced side effects for 7 days following the vaccine. Study procedures will include up     to 3 blood sample collections. Participants will be involved in study related procedures for     up to 6 months.   "
183148|NCT00240669|"     Primary objective : To evaluate the quality of fractures setting and osteotomy of the facial     massif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates.      Secondary objective :        -  To evaluate the resorbable device ergonomy versus Titanium.        -  To evaluate the clinical tolerance of resorbable device versus Titanium.      Hypothesis :      Osteosynthesis with resorbable device demonstrates a non inferiority success probability     regarding the success observed in osteosynthesis with Titanium, with a less important     probability of re-operation.      Study duration : 14 months for each patient.      Study treatment :        -  Group I : Resorbable device PLLA/PGA.        -  Group II : Titanium device.      Study visits :      - Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day     45(Traumatology)/Day 90 (orthognatic) – Month 6,12 and 14.      Randomization : Stratification by centres, mono or bimaxillar surgery and traumatologic or     orthognatic criteria.   "
183149|NCT00240682|"     The purpose of this study is to determine whether cetuximab is effective in the treatment of     locally advanced or metastatic squamous cell carcinoma of the skin expressing EGFR.   "
183150|NCT00240695|"     The purpose of this follow-up study is to assess the long-term safety and tolerability of     galantamine in individuals with mild cognitive impairment who participated in a previous     study with galantamine   "
183151|NCT00240708|"     The purpose of this study is to evaluate the effectiveness and safety of risperidone,     formulated as a long-acting injectable drug, compared with risperidone tablets in the     treatment of patients with schizophrenia.   "
183152|NCT00240721|"     The primary purpose of this study is to evaluate the effectiveness and safety of topiramate     compared with placebo in the treatment of acute manic or mixed episodes in patients with     Bipolar I Disorder.   "
183153|NCT00240734|"     The purpose of this study is to compare the proportion of subjects receiving either Epoetin     alfa (PROCRITÂ®) or placebo who are able to achieve a hemoglobin response, defined by at     least a 1 gram/deciliter increase from baseline by Week 17.   "
183154|NCT00240747|"     Open-label, multicenter, multiple-dose, study of population pharmacokinetics of I.V. Synercid     (7.5 mg/kg every 8 hours) in 75 pediatric patients. The purpose is to assess the population     pharmacokinetics of Synercid in pediatric patients and to collect additional safety and     efficacy data in pediatric patients.   "
183155|NCT00240760|"     This is a study to assess whether memantine is effective and safe in preventing age related     cognitive deterioration and dementia in people with Down's syndrome (DS) age 40 and over. The     study will last for a year and it will include 180 people with Down's syndrome with and     without dementia. Participants will be assessed on memory skills, attention and problem     solving abilities. Quality of life and abilities for everyday living skills will also be     regularly checked.      Primary Aims      Clinical:        -  To determine the clinical efficacy of memantine versus placebo in preventing cognitive          decline in people with DS.        -  To compare the safety and tolerability of memantine versus placebo in people with Down’s          syndrome (DS).      Biochemical and pathological:        -  To examine the ability of memantine to alter markers of disease progression in DS          patients.      Secondary Aims      Clinical:        -  To determine whether memantine has, as compared with placebo, a significant positive          impact on:             -  level of independent functioning as measured by the carer-rated adaptive               behavioural scale, (ABS) in adults with DS;             -  quality of life in adults with DS.      Biochemical and pathological:        -  To investigate putative markers of memantine’s mechanism of action in peripheral samples          from living patients with DS.   "
183156|NCT00240773|"     The purpose of this study is to compare the long-term safety and effectiveness of     acetaminophen (4000 mg per day) and naproxen (750 mg per day) in the treatment of     osteoarthritis of the hip or knee.   "
183157|NCT00240786|"     The purpose of this study is to determine the safety and effectiveness of 650 mg and 1300 mg     acetaminophen extended release given three times a day for the relief of signs and symptoms     of osteoarthritis of the hip or knee for a period of 12 weeks.   "
183158|NCT00240799|"     The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day)     compared to placebo for safety and effectiveness in the relief of signs and symptoms of     osteoarthritis of the hip or knee over 12 weeks   "
183165|NCT00240903|"     The purpose of this study is to determine whether having received an H5 vaccine in the past     primes the immune system to respond rapidly to another dose of H5 vaccine. One hundred     seventeen participants in a previous vaccine study (involving the A/Hong/Kong/97 virus)     during the fall of 1998 at the University of Rochester will be eligible to enroll in this     study. Participation in this study will up to 64 days and will involve donation of small     samples of blood 7, 28, and 56 days after vaccination.   "
183166|NCT00240916|"     This is an immunogenicity study evaluating the development of the immune response of healthy     infants following primary vaccination with Attenuvax at 6 or 9 months of age compared with     responses in 12 month-old infants receiving MMR-II. Responses of infants receiving an early     two dose measles vaccine regimen with the first dose given at 6 or 9 months followed by a     second dose administered at 12 months will also be compared to infants given a single dose at     12 months of age (Table 2). The current approved regimen for measles vaccination is a first     vaccination at 12-15 months and a subsequent vaccination at school entry.      A secondary endpoint of this study will be to assess the safety of measles vaccine     administered as Attenuvax at 6 or 9 months of age and in an early two dose measles vaccine     regimen with Attenuvax administered at 6 or 9 months followed by MMR-II at 12 months of age.   "
183167|NCT00240929|"     A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of     the following treatment sequence A or B.   "
183168|NCT00240942|"     Endometriosis is a condition in which abnormal growth of tissue histologically resembling the     lining of the uterus (endometrium) is present outside of the uterus. This study will     investigate the effect of a daily dose of letrozole compared to GnRH is safe and in addition     effective in reducing measurable endometriosis lesions and in reducing pain in patients with     active endometriosis which were pretreated with GnRH analogs for 2 months.   "
183169|NCT00240955|"     The objective of this study is to assess the long-term safety and tolerability of EC-MPS on     the patients who completed the core study and wish to continue treatment on EC-MPS.   "
183171|NCT00240981|"     The purpose of this study is to determine whether testosterone replacement in older men with     low testosterone levels will increase muscle strength, improve physical performance and     overall sense of well being, and reduce fatigue.   "
183172|NCT00240994|"     The purpose of this study is to evaluate the safety of alemtuzumab after kidney     transplantation as part of a multitherapy regimen to prevent kidney graft loss and death and     to avoid steroids and chronic use of calcineurin inhibitors in pediatric renal transplant     recipients 1 to 20 years of age.   "
183173|NCT00241007|"     SAFETY EXTENSION STUDY TO THE CORE STUDY CVAH631C2301   "
183174|NCT00241020|"     Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an     increasing incidence in industrialized countries. For patients with advanced HCC no efficient     treatment is currently available. The objective of this study is to assess the efficacy and     safety of octreotide in patients with advanced hepatocellular carcinoma.   "
183175|NCT00241046|"     The course of the disease in female patients with metastatic mammary carcinoma can vary     greatly. In this connection, the individual prognosis depends on a complex interaction of     tumor- and patient-related factors. To take account of such differences, it is necessary to     employ individual methods of treatment which are suited to the course of each patient's     disease. Prof. Possinger and Dr. Schmid (Charite Berlin) and Prof. Wischnewsky (University of     Bremen) have developed an approach that can help to achieve this goal with the aid of     computerized machine learning techniques (MLT).      The use of machine learning methods can be beneficial in oncology in two respects. On the one     hand, an attempt can be made to individually estimate clinically relevant parameters like,     for example, the recurrence probability or expected survival time as precisely as possible     based on the established prognostic factors. And on the other hand, it may be possible with     the aid of MLT to understand structural relationships between the clinical result and     measured or established tumor-/patient-related variables.      To analyze the possible benefits of machine learning techniques for patients with metastatic     breast cancer, the aim of study FEM-D-2 is to investigate whether it is possible to     characterize those patients who either do or do not respond to a specific treatment with a     precision of 90%, prospectively estimate the time until worsening of the disease under a     given treatment, and classify patients in groups with favorable and poor chances of     medium-term survival.      The use of inductive learning algorithms with machine learning also makes it possible to very     accurately estimate the time until progression of the tumor growth. In patients who respond     to letrozole therapy, the time until tumor progression depends on factors like pain, age,     body mass index, disease-free interval, main localization of metastatic spread, and response     to previous estrogen therapy. Only very minimal differences are found when comparing the     actual time until progression of the disease and that calculated by the system (at least for     survival times < 1 year). Furthermore, using machine learning techniques it has become     possible to use initial data assessed before a letrozole treatment to estimate the survival     time and distinguish patients with a high risk of dying soon from other patients with a more     favorable prognosis.   "
183176|NCT00241059|"     The objective of this extension study is to allow patients being treated with enteric-coated     mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to     assess the long-term safety of EC-MPS.   "
183177|NCT00241072|"     THE PURPOSE OF THIS STUDY IS TO DETERMINE IF 24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG -     320 MG) IMPROVES INSULIN SENSITIVITY IN SUBJECTS WITH HIGHER THAN NORMAL GLUCOSE LEVELS USING     A TEST CALLED THE EUGLYCEMIC CLAMP.   "
183178|NCT00241085|"     This is a study of whether valsartan affects levels of proteinuria in patients with type 2     diabetes and hypertension.   "
183179|NCT00241098|"     This is a study to evaluate the response of patients with hypertension and early stage heart     failure to valsartan.   "
183180|NCT00241111|"     Study to determine effectiveness and safety of zoledronic acid and whether it has a     pharmaco-economic impact in prostate cancer with bone metastasis.   "
183181|NCT00241124|"     A study comparing the antihypertensives Valsartan and Lisinporil when doses are in the     morning and comparing a morning dose of Valsartan with an evening dose.   "
183182|NCT00241137|"     The purpose of this was to evaluate valsartan 320mg compared to valsartan 160 mg in terms of     blood pressure reduction in a patient population of mild to moderate hypertensives   "
183184|NCT00241163|"     The overall objective is to compare efficacy and safety of TachoComb S and standard surgical     treatment for the control of local bleeding in patients undergoing surgical resection of     renal tumours. Specific objectives include the comparison between test treatments of     intra-operative haemostatic efficacy as well as post-operative blood loss, haematoma     formation, and surgeon's rating of usefulness of test treatment.   "
183185|NCT00241176|"     The purpose of this study is to determine if Abilify will reduce tics (repetitive,     uncontrollable movements or vocalizations) in children and adolescents ages 7-18 with     Tourette's Disorder (TD) or a chronic motor tic disorder (either repetitive, uncontrollable     movements or vocalizations).   "
183186|NCT00241189|"     This is a study to determine the safety of the immunosuppressive rapamycin in patients with     systemic sclerosis with diffuse cutaneous scleroderma. The effects (both good and bad) are     being compared to another group of systemic sclerosis patients receiving methotrexate   "
183187|NCT00241202|"     The goals of this research are: 1) To test the efficacy of a self-care symptom management     manual by examining whether people who use the manual find it to be useful; 2) To examine     symptom and demographic data related to self-care behaviors, symptom control, medication     adherence and enhanced quality of life.      The University of California, San Francisco is the coordinating site for this multi-site     international study.   "
183188|NCT00241215|"     Several studies have previously examined the use of botulinum toxin serotype A for myofascial     pain of the neck and shoulders (cervicobrachial syndrome). These studies have suffered from:        1. inclusion of confounding conditions in the proband group, and        2. inability to identify predictors of response.      This study attempts to define the characteristics of responders to botulinum serotype A for     myofascial pain of the neck and shoulders (cervicobrachial syndrome).   "
183189|NCT00241228|"     Sepsis and septic shock are still important causes of mortality in intensive care medicine.     Renal replacement therapy by standard volume haemofiltration is currently used, but a     higher-volume haemofiltration may improve the prognosis. The study is a prospective     randomized multicenter trial comparing two treatments in patients suffering from septic shock     complicated with acute renal failure admitted to ICU. One group will be treated by early high     volume haemofiltration (70 ml/kg/h) and the second group by standard volume haemofiltration     (35 ml/kg/h). The main outcome will be one-month mortality.   "
183190|NCT00241241|"     Interferon alfa is an effective treatment of polycythemia vera (PV), but about 20% of     patients discontinue their treatment because of side effects and treatment schedule (three     times per week administration). The pegylated form of interferon alfa-2a has shown a better     tolerance in hepatitis patients and is administered only once a week. The purpose of this     study is to determine efficacy and safety of pegylated interferon alfa-2a in the treatment of     PV patients.   "
183191|NCT00241254|"     Preliminary not-controlled clinical studies of the efficacy of monthly intravenous     cyclophosphamide administration in secondary progressive multiple sclerosis reported     encouraging results, but no randomized controlled trial has been conducted so far. The     primary objective of this trial is to evaluate the efficacy of IV cyclophosphamide as     compared to IV methylprednisolone administered every 4 weeks during 1 year and every 8 weeks     during 1 year, on the delay to confirmed disability deterioration as assessed by the Expanded     Disability Status Scale (EDSS) in patients with secondary progressive multiple sclerosis. The     secondary objectives are to evaluate safety, tolerability and efficacy at 2 years on the     Multiple Sclerosis Functional Composite (MSFC), the percentage of patients with disability     deterioration (EDSS) and the number of relapses. An intention-to-treat statistical analysis     will be carried out.   "
183192|NCT00241267|"     The exploration of neoplastic pulmonary pathology is based on computed tomography and     bronchoscopy. This allows targeted samples of the identified lesions.      A new ultrasonographic method is proposed as a non invasive and non irradiating technic by     using a dedicated probe easily introduced via the channel of the fibrescope, so as to     complete the identification of peripheral lesions.   "
183193|NCT00241280|"     Study in the US intended to evaluate the safety and effectiveness of a Johnson & Johnson     Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6     nights).   "
183194|NCT00241293|"     The purpose of this study is :        -  to look for changes induced by aging in a population of old subjects, during silent word          generation tasks studied by fMRI.        -  to look for a possible link between these changes and alterations in language   "
183195|NCT00241306|"     The purpose of this study is to determine whether gender and age modify cerebral activations     during a silent word generation functional Magnetic Resonance task.   "
183196|NCT00241319|"     The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution     compared with placebo in alleviating the signs and symptoms of conjunctival allergen     challenge-induced allergic conjunctivitis   "
183197|NCT00241332|"     The aim of this trial is to examine the possibility that fentanyl 1,5 µgr/kg given     intravenously (i.v.) before the start of remifentanil infusion for anesthesia gives less     development of tolerance/hyperalgesia postoperative than fentanyl given at the end of surgery     (the traditional method).   "
183198|NCT00241345|"     The purpose of this trial is to determine if preemptive therapy with oral valganciclovir is     as effective as intravenous ganciclovir in clearing cytomegalovirus (CMV) viremia as     determined by quantitative CMV polymerase chain reaction (PCR) assay in patients who have     undergone bone marrow or peripheral blood stem cell transplant.   "
183199|NCT00241358|"     The purpose of this study is to determine if peripheral blood cells collected following     AMD3100 mobilization can be used safely for hematopoietic cell transplantation into     HLA-matched recipients.   "
183200|NCT00241371|"     To determine the overall response rate (CR+PR) of patients with relapsed or refractory     multiple myeloma treated with clofarabine.   "
183201|NCT00241384|"     The primary purpose of this study is to evaluate two treatment regimens for prostate cancer,     prostate implant with 20 Gy of external beam radiation therapy versus prostate implant with 0     Gy of external beam radiation therapy. Patients diagnosed with intermediate risk prostate     cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external     beam radiation therapy as their intended treatment will be eligible and will be offered     participation.   "
183202|NCT00241397|"     The purpose of this study is to assess the prevalence of Major Depression and/or Anxiety     Disorder in patients consulting the General Practitioner with acute or chronic painful     physical symptoms and to identify risk factors.   "
183203|NCT00241410|"     Safety and tolerability of different dose combinations of MPL and grass pollen allergen and     to identify the highest combinations of MPL and grass pollen allergen which is safe.      Pharmacodynamics and efficacy of MPL and grass pollen allergen.   "
183204|NCT00241423|"     The purpose of this study is to test the hypothesis that in patients with type 2 diabetes,     the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour     period, compared with placebo.   "
183205|NCT00241436|"     The purpose of this study is to evaluate the safety, effectiveness, pharmacokinetics and     pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.   "
183206|NCT00241449|"     The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex     (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer.     Patients will be treated until disease progression or until the investigator has determined     that treatment is not in the best interest of the patient, whichever occurs first.   "
183207|NCT00241462|"     The purpose of this study is to identify which patients, receiving Faslodex within the     approved label, benefit most from Faslodex treatment.   "
183208|NCT00241475|"     To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA     response rate at study closure   "
183209|NCT00241488|"     This clinical trial is being performed to investigate the effect of 12 weeks treatment with     rosuvastatin and atorvastatin in bringing subjects to their established EAS LDL-C target     goal.   "
183210|NCT00241501|"     This study is a phase III, multi-centre, randomized, double-blind study to assess the safety     and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and     adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The     treatment period will be up to 8 weeks.   "
183211|NCT00241514|"     This study was a multicentre, double-blind, randomised, placebo-controlled parallel group     study consisting of 4 visits over a period of 6 months. The primary variable was to assess     the efficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20)     versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper     GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients     receiving daily NSAID therapy.   "
183212|NCT00241527|"     This study was a randomised, double-blind, parallel-group and placebo controlled study     comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg     orally qd vs placebo when given to patients on continuous use of NSAIDs, including COX-2     selective NSAIDs, for a treatment period of 4 weeks for relief of upper GI symptoms.   "
183213|NCT00241540|"     This study is a randomised, double-blind, parallel-group and placebo controlled study     comparing the efficacy of esomeprazole 40 mg orally qd vs. placebo and esomeprazole 20 mg     orally qd vs. placebo when given to patients on continuous use of NSAIDs, including COX-2     selective NSAIDs, for a period of 4 weeks in treatment of relief of upper GI symptoms.   "
183214|NCT00241553|"     This study was a multicentre, double-blind, randomised, placebo-controlled parallel group     study consisting of 4 visits over a period of 6 months. The primary variable was to assess     theefficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20)     versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper     GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients     receiving daily NSAID therapy.   "
183215|NCT00241566|"     All neuropathic chronicle pains are difficult to treat. Currently many patients are not     relieved by electric stimulations of central nervous system, existing. Recently cortical     stimulation had a development important and benefit effects are proven. In this study we     evaluate medico-economic impact of this treatment.   "
183216|NCT00241579|"     The purpose of this study is to determine whether or not inhaled marijuana displays any     pain-relieving properties on experimentally-induced pain.   "
183217|NCT00241592|"     A study to evaluate the use of a vaporization system as a smokeless delivery system for     inhaled marijuana.   "
183218|NCT00241605|"     This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control     in patients with Type 2 Diabetes Mellitus.   "
183219|NCT00241618|"     Spontaneous resolution of acute hepatitis C infection cannot be predicted and the majority of     cases persist and become chronic. This randomized trial assesses the efficacy and safety of     peginterferon alfa-2b. The investigators hypothesize that therapy strategies could prevent     the development of chronic hepatitis.   "
183220|NCT00241631|"     The global burden of COPD − a common and debilitating chronic inflammatory disease that is     characterised by the progressive development of airflow limitation (shortness of breath −     SOB) and is poorly reversible with currently available drugs −is increasing. Cigarette     smoking is strongly linked with the ongoing inflammation; inflammation that can continue even     when the patient has stopped smoking. The severity of airflow limitation (SOB) is correlated     with the degree of pulmonary (lung) inflammation.      Histone deacetylases (HDACs)are important molecules in suppressing this pulmonary     inflammation. We have recently shown that patients with COPD have a reduction in total HDAC     which correlates with the severity of their lung disease.      Corticosteroids (anti−inflammatory treatment) act, at least in part, by recruitment of these     HDACs to the site of active inflammatory gene transcription (which reduces the production of     inflammatory molecules) and are widely used in COPD in patients with severe disease.     Unfortunately, in COPD, inhaled corticosteroids seem to have little effect on the underlying     inflammation (though in a selective group of patients with COPD they do reduce the number of     infections a patient may have by a small amount). Theophylline has been used in the treatment     of asthma and COPD for over 70 years, but its use has recently declined. Data so far obtained     in primary cells (cells from patients used in the laboratory) from COPD patients suggests     that low dose theophylline (~5mg/l) should be effective in restoring steroid sensitivity in     patients with COPD (and hence reduce inflammation thus improving SOB). We wish therefore to     continue these studies on theophylline principally by conducting a small clinical pilot study     on 20−30 COPD patients in a randomised, double−blind, placebo−controlled, parallel−group     study.   "
183243|NCT00241943|"     The investigators hypothesize that a well-designed hepatitis C (HCV) video education     curriculum for active drug injectors will lead to measurable improvements in HCV testing     rates, HAV and HBV vaccination rates, as well as knowledge and attitudes about this     condition. The investigators will use a short 10 minute video designed for active drug users     to and assess its impact vs. a usual-care counseling intervention. The investigators will     measure and compare its impact at baseline, 4 weeks after video viewing, and 12 weeks after     intervention.   "
183221|NCT00241644|"     The primary objective of this study is to determine if the GSK Biologicals' human rotavirus     (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on     immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the     20-point Vesikari scoring system [Ruuska, 1990]) caused by the circulating wild-type RV     strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until     Visit 5.      The primary objective will be reached if the lower limit of the 95% confidence interval (CI)     on vaccine efficacy is >0%.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
183222|NCT00241657|"     BCG vaccination has been found to provide greater protection against TB in the UK than in     Malawi. This study compares immune responses in BCG-vaccinated and unvaccinated teenagers and     young adults in Malawi and in the UK.   "
183223|NCT00241670|"     The aim of the study Fluorescence-guided resection of malignant gliomas with     5-Aminolevulinic acid (5-ALA) vs. conventional resection is to determine how accurately     contrast agent-accumulating tumour can be removed by primary surgery and to assess the     clinical usefulness of this method.   "
183224|NCT00241683|"     To determine whether or not women with a history of having a baby with intrauterine growth     retardation (IUGR) was more likely to have risk factors for cardiovascular disease versus     women with a pregnancy not complicated by IUGR.   "
183225|NCT00241696|"     To examine air pollution, inflammation and new onset asthma in a large cohort of children in     southern California.   "
183226|NCT00241709|"     The purpose of this study is to examine the effectiveness of approaches to correct for the     effects of population stratification on case-control genetic association studies.   "
183228|NCT00241735|"     To investigate whether soy food intake reduces risk of non-fatal myocardial infarction (MI)     and fatal coronary heart disease in Chinese women.   "
183229|NCT00241748|"     To conduct a case-control study of factors that increased the risk of rhabdomyolysis, an     adverse drug reaction in cerivastatin users   "
183230|NCT00241761|"     To understand how depression leads to congestive heart failure (CHF) in older adults.   "
183231|NCT00241774|"     To examine the associations among depression, inflammation, and coronary heart disease using     an existing data base and associated plasma samples.   "
183232|NCT00241787|"     To determine the rate of progression of sub-clinical cardiovascular disease as measured in     carotid intimal medial thickness over a period of 8 to 10 years.   "
183233|NCT00241800|"     To investigate a potential relationship between four different classes of non-cardiovascular     drugs and the risk of sudden cardiac death.   "
183234|NCT00241813|"     This study will examine the effects of two behavioral stress reduction programs, mindfulness     meditation (MM) and the lifeskills program (LP), and a health education control program (CTL)     on blood pressure.   "
183235|NCT00241826|"     The purpose of this study is to determine the diagnostic accuracy of gadolinium-enhanced     magnetic resonance angiography (Gd-MRA) of the pulmonary arteries in combination with     magnetic resonance venography (MRV) of the veins of the thighs in patients with clinically     suspected acute pulmonary embolism (PE).   "
183236|NCT00241839|"     This study will test the hypothesis that the administration of a xanthine oxidase inhibitor     (allopurinol) will prevent thiazide-induced hyperuricemia, which will result in better blood     pressure (BP) control in African Americans.   "
183237|NCT00241852|"     The purpose of this study is to test two asthma management programs: (a) a school-based     curriculum to empower middle school students to manage their asthma and (b) a parent training     curriculum to teach childrearing skills that support the youths' growing autonomy and need to     self-manage their disease.   "
183238|NCT00241878|"     The purpose of this study is to compare changes in body mass index (BMI) among 3- to     5-year-old minority children randomized to a weight control intervention (WCI) or a general     health control intervention.   "
183239|NCT00241891|"     This study will train primary care providers to counsel families on behavior change that is     aimed at reducing the rate of weight gain in at-risk children.   "
183240|NCT00241904|"     PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON     FAMILY HEALTH CENTER.      The purpose of this study is to compare the clinical effectiveness and cost effectiveness of     two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with     a less intensive (LI) intervention - in African American, and white low-income patients with     known excessive cardiovascular disease risk.   "
183241|NCT00241917|"     The investigators hypothesize that a well-designed hepatitis C (HCV)video education     curriculum for high-risk drug users will show measurable benefits in improving HCV testing,     hepatitis A and B vaccinations, and HCV knowledge, attitudes, and motivations toward     transmission behavior change. The investigators will use a 4-part modular video series     designed for at-risk drug users, and in this 12 week study will assess its impact on     testing/vaccinations as well as knowledge, attitudes, and motivations in methadone-maintained     drug users as compared to a usual-care intervention.   "
183242|NCT00241930|"     We hypothesize that integrating drug treatment into HIV treatment will improve HIV outcomes     as well as drug treatment outcomes in heroin users. This study will test this hypothesis by     randomizing patients to two groups. The first group will receive HIV treatment and     buprenorphine treatment contemporaneously at their HIV clinic. The second group will receive     HIV treatment at their HIV clinic, and go to another facility to receive buprenorphine     treatment services.      We will look at HIV outcomes such as CD4 counts, HIV viral loads, and attendance at     appointments and drug treatment outcomes such as receipt of buprenorphine and urine     toxicology testing.   "
183244|NCT00241956|"     To assess whether patients with diabetes have less clinical improvement during inpatient     rehabilitation than those without diabetes and whether hyperglycaemia during rehabilitation     is an adverse prognostic indicator.   "
183245|NCT00241969|"     The primary objective of this NIH funded clinical trial is to conduct a multi-center,     randomized, controlled trial comparing two interventions: a behavioral plus nutrition     intervention to a nutrition intervention. This study will (a) determine the impact of the     behavioral intervention on energy intake and weight gain; (b) examine the durability of the     behavioral intervention's impact on growth (weight and height) one year following treatment;     and (c) explore the relation between physical activity and growth.   "
183246|NCT00241982|"     Trial to study the safety of a single, intravenous administration of long-circulating     liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.   "
183247|NCT00241995|"     The study is aimed to evaluate the efficacy of antiglutamate anticonvulsants (topiramate,     lamotrigine, and memantine) in the treatment of alcohol withdrawal syndrome   "
183248|NCT00242008|"     The purpose of this trial is to assess whether it is possible for subjects with idiopathic     Parkinson's Disease to switch from ropinirole, pramipexole and cabergoline to rotigotine     transdermal system (SPM 962) overnight without worsening of Parkinson's Disease symptoms.      Subjects who meet eligibility criteria will be switched overnight to treatment with     rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine     agonist that the subject is currently taking. Subjects on ropinirole or pramipexole will take     their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next     morning. Subjects on cabergoline will apply rotigotine patches 24 hours after the final dose     of cabergoline. Subjects will continue rotigotine treatment for 28 days, during which dose     can be increased or decreased as needed. At the end of treatment, subjects can select to     enroll in an open-label extension trial.      The first subject was enrolled on 28 December 2004. The last subject was enrolled in June     2005 and the last subject visit was conducted in July 2005. This study is now closed.   "
183249|NCT00242021|"     The objective of the study is to investigate the effect of fatty acid composition of a fat     supplement:        1. acutely (after single intake) on subjective and objective measurements of hunger,          satiety and wellness, on energy intake, and postprandial hormonal changes;        2. in the long-term (after one week) on (regulators of) fat tissue metabolism.   "
183250|NCT00242034|"     In cervix cancer tumor oxygen levels and fluid pressure in the tumor have been shown to be     related to patient outcome. Analysis of the way tumors enhance after intravenous contrast     injection using MRI and CT can be used to determine parameters that relate to tumor blood     vessels. In this study we hope to determine if there is a relationship between the     enhancement of cervix cancer on MRI and CT and tumor oxygen levels and interstitial fluid     pressure. If such a relationship exists then it could help improve the care of patients wiht     cervix cancer by allowing for more aggressive therapy of patients with cancer that have more     ominous imaging characteristics   "
183251|NCT00242047|"     An open label, randomized, controlled, equivalency trial to compare the efficacy of the     percutaneous route of administration with the intradermal route of administration of Japanese     (Tokyo) 172 BCG, in the prevention of tuberculosis during the first two years of life.   "
183263|NCT00242203|"     This study is designed to evaluate the impact of Zometa on clearance of bone marrow     micrometastases; the protective effect on chemotherapy-induced loss of bone mineral density;     and quality of life in women undergoing treatment for locally advanced breast cancer.   "
183252|NCT00242060|"     Prostate specific antigen (PSA) and digital rectal exam (DRE) are used to screen for prostate     cancer. Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided     biopsy (TRUS-Bx). There are some men who have a normal TRUS-Bx despite persistent elevated     PSA and may harbor occult prostate cancer. The purpose of this study is to determine if MRI     using an endorectal coil, and advanced MRI methods called H1 MR Spectroscopy (MRS) and     Dynamic MR Perfusion Imaging (dMRI) can help identify and localize prostate cancer in these     patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland. 100     men, currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in     the study.   "
183253|NCT00242073|"     Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence     the success of treatment and the progression of disease in prostate cancer. The method used     to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself     through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI     technique that allows indirect assessment of oxygen levels in blood. This technique is     non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer.     The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively     measure changes related to tumor hypoxia in prostate cancer. This technique may provide     information that will be an independent predictor of patient survival, tumor recurrence and     likelihood of treatment response in prostate cancer   "
183254|NCT00242086|"     The purpose of this study is to correlate the MRI CT and PET appearances of colorectal liver     metastases to pathologic appearance ot better understand the accuracy of imaging to determine     tumor size.   "
183255|NCT00242099|"     Human herpesvirus-6 (HHV-6) and -7 (HHV-7) infections are common after transplantation. Such     infections may predispose transplant patients to other infections, contribute to a recurrence     of hepatitis C virus, and affect rejection and function of the transplanted liver. Given the     significant clinical impact of these viruses, routine laboratory monitoring may be beneficial     by identifying patients who have persistent or high levels of infection. In these patients,     immunosuppressive medications could be adjusted, or antiviral medications administered. There     are currently no randomized trials that address this important question. This prospective,     randomized trial will analyze whether routine laboratory monitoring for HHV-6 and -7 is     clinically useful, and whether it would improve overall outcomes in transplant recipients.   "
183256|NCT00242112|"     The purpose of this study is to determine the ability of functional MRI techniques to detect,     measure and locate intra-prostatic cancer.   "
183257|NCT00242125|"     Primary biliary cirrhosis (PBC) is a chronic liver disease primarily affecting middle age     women. It is characterized by immune-mediated damage to cells lining the tiny bile ducts     within the liver. Although the underlying cause of PBC is likely to be multifactorial, the     epidemiologic/population data indicate a very important role for genetic predisposition,     meaning that the disease seems to run in families. Susceptibility genes for PBC have not been     identified possibly due to limitations such as small sample size in prior studies. The     primary objective of this study is to identify these genes. This study involves obtaining     clinical and demographic data as well as collecting DNA samples from patients and their     parents, and siblings to screen for a select set of candidate genes as well as the full     genome for variants associated with PBC.   "
183258|NCT00242138|"     The optimal duration of hormonal therapy is yet to be determined in the treatment of locally     advanced carcinoma of the prostate. The RTOG performed a trial of 4 months of neoadjuvant and     concurrent hormones(consisting of Goserelin and Flutamide) compared to radiation alone, and     found that there was an improvement in local control and progression-free survival, but no     improvement in overall survival. The EORTC performed a similar trial, but used Goserelin     alone for a period of 3 years. This trial showed an improvement in local control,     disease-free survival, and in contrast to the RTOG trial, an improvement in overall survival.      The rate of erectile dysfunction in men who receive a prolonged period of Gosereline (i.e. 2     yrs) is not known, but suspected according to expert opinion, to be significantly higher than     a shorter course of hormonal ablation. Therefore the price of of a survival advantage in     locally advanced prostate cancer maybe at a cost of increased rates of erectile dysfunction.   "
183259|NCT00242151|"     The objective of this study is to determine prevalence of postoperative delirium and     confusion in patients undergoing cardiac surgery. This proposal is a pilot study designed to     evaluate effect of cardiac surgery on prevalence of delirium and confusion.      The primary aim is to evaluate prevalence of delirium and confusion in patients undergoing     cardiac surgery and to determine risk factors for this condition.      A secondary aim is to evaluate organic brain injury by early postoperative diffusion weighted     magnetic resonance imaging (DW-MRI) in patients who develop delirium and confusion.      The hypothesis to be tested is that patients with postoperative delirium and confusion have     high incidence of organic brain injury as detected by DW-MRI.   "
183260|NCT00242164|"     The study is being performed to better understand dialysis techniques which keep heart     functions stable during dialysis. People on dialysis have a high risk for heart disease and     strokes. More information about dialysis techniques that keep hearts stable may help prevent     the high risk of cardiovascular disease and death and help to reduce discomfort during     dialysis. This study will look at the way that the magnesium in dialysate affects heart     function during dialysis. High or low levels of magnesium may change the way hearts beat. The     question asked is if lowering the amount of magnesium in dialysate will affect the amount of     magnesium in blood or change the heart beat.   "
183261|NCT00242177|"     The purpose of this study is to determine whether an already FDA approved drug is safe and     tolerable in Relapsing Remitting Multiple Sclerosis patients.   "
183262|NCT00242190|"     This study will examine a proposed research treatment which evaluates the addition of     oxaliplatin, a chemotherapy agent, to gemcitabine, another chemotherapy agent, and radiation     therapy for the treatment of patients with pancreatic cancer. The researchers have already     done studies using gemcitabine and radiation therapy together. They want to build on the     information they have from this previous research. The researchers believe that the     combination chemotherapy with radiation is worth investigating to treat pancreatic cancer.     They will use this study to determine what type of side effects occur with this treatment and     to assess how effective the treatment is at controlling the cancer.   "
183264|NCT00242216|"     Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be     administered once-a-day and boosted with ritonavir (r). Prior studies have demonstrated that     both are effective in treatment of ARV-naïve HIV-infected people. This study was designed to     demonstrate if a HAART regimen containing ATV/r is not inferior to a HAART regimen containing     fAPV/r, in ARV-naïve patients over a 96-week period.      This is a phase IV, single center, randomized, open label, 2-arm clinical trial in ARV     therapy-naïve patients with HIV-1 RNA >1,000 copes/mL and CD4 cell count <350 cells/mm3.     Patients will be randomized to receive tenofovir and emtricitabine plus either ATV (300mg qd)     and ritonavir (100mg qd) or fAPV (1400mg qd) and ritonavir (200mg qd).   "
183265|NCT00242229|"     To evaluate the overall safety and tolerability profile of two dose levels of DVS-233 SR     during 6 months of open-label treatment in elderly outpatients with major depressive     disorder.   "
183266|NCT00242242|"     This study will gain information on methods of control of a prosthetic arm in stroke patients     or traumatic brain inury patients through a technique called brain-computer interface     (BCI). BCI allows for direct communication between man and machine. Brain cells communicate     by producing electrical impulses that help to create such things as thoughts, memory,     consciousness and emotions. In BCI, brain waves are recorded by an electroencephalogram (EEG)     through electrodes (small wires) attached to the scalp. The electrodes measure the electrical     signals of the brain. These signals are sent to the computer, which translates them into     device control commands as messages that reflect a person's intention. This type of brain     activity comes from the sensorimotor areas of the brain and can be controlled through     voluntarily training to control the hand prosthesis through the BCI.      Healthy normal volunteers and people who have had a stroke or traumatic brain injury more     than 12 months ago and have paralysis in the right or left arm, hand or leg and who are     between 18 and 80 years of age may be eligible for this study. Candidates are screened with a     clinical and neurological examination and magnetic resonance imaging (MRI) of the brain. MRI     uses a magnetic field and radio waves to obtain images of the brain. The scanner is a metal     cylinder surrounded by a strong magnetic field. During the procedure, the subject lies in the     scanner for about 45 minutes, wearing ear plugs to muffle loud knocking sounds that occur     with the scanning.      Participants undergo the following procedures:        -  Sessions 1-2: Participants are connected to an EEG machine and familiarized with the          hand orthosis (training device used in the study) and the tasks required for the study.        -  Sessions 3-4: Participants receive baseline transcranial magnetic stimulation (TMS) and          fMRI. For TMS, a wire coil is held on the scalp. A brief electrical current is passed          through the coil, creating a magnetic pulse that stimulates the brain. The subject may          feel a pulling sensation on the skin under the coil and there may be twitching in          muscles of the face, arm or leg. The subject may be asked to tense certain muscles          slightly or perform other simple actions. The effect of TMS on the muscles is detected          with small metal disk electrodes taped to the skin of the arms. fMRI is like a standard          MRI (see above), except it is done while the patient performs tasks to learn about brain          activity involved in those tasks.        -  Sessions 5-8: Participants are asked to repetitively move their hand (patients'          paralyzed hand; healthy volunteers' normal hand), tongue and leg in response to three          sound tones. After ten trials, they are asked to imagine the same movements 50 to 100          times while the EEG machine is recording brain activity.        -  Sessions 9-14: Participants are trained in controlling the hand orthosis. The subject's          hand is attached to the orthosis and asked to imagine that they are performing finger or          hand movements. This continues until there is an 80-90 percent success rate in achieving          hand movement.        -  Sessions 15-16: Participants repeat TMS and fMRI for comparison before and after          training with the hand orthosis.        -  Sessions 17-28: Participants receive additional training with the hand orthosis device          (as in sessions 5-8), focusing only on the hand and not other parts of the body.        -  Sessions 29-30: Participants undergo repeat TMS and fMRI to compare with the effect          following additional training with the hand orthosis.        -  Sessions 31-32: Optional makeup sessions if needed because of scheduling problems.      Participants are evaluated in the clinic after 3 months to see if they have benefited from     the study.   "
183267|NCT00242255|"     This study will examine the role of epigenetics (heritable changes in gene function that     occur without a change in DNA sequence) in the aging process. DNA is the primary genetic     material, responsible for transmitting information from one cell to the next or from one     generation to the next. A second layer of heredity is described by the term epigenetics.      Epigenetic information is reset from one generation to the next. It works in two ways: 1) by     modification of the DNA, like balloons stuck at irregular intervals onto the sides of the DNA     helix that encodes genes, and 2) through specialized protein shells that wrap around some     regions of DNA. As in DNA, these shells can copy themselves and can transmit instructions.     Because they are used to turn genes on and off, errors in their settings cause critical     misinformation to be transmitted.      Aging involves many changes, such as muscle weakening, graying hair, skin wrinkling, and so     forth. There are several current theories of aging, including damage to genes by oxidation,     shortening of tiny structures at the ends of chromosomes called telomeres, and the ability to     stretch lifespan with caloric restrictions. This study will investigate the possible role of     epigenetics in aging by examining and comparing the shell-like epigenetic settings in skin     cells in young adults and older individuals. Preliminary results from earlier studies show     differences in these settings in younger and older people.      Women between the ages of 21 and 30 years and 65 and 90 years who are undergoing breast     reduction or mastectomy at Suburban Hospital in Bethesda, Maryland, may participate in this     study. Tissue removed during surgery for pathological examination will also be used by     researchers in this study to validate the preliminary findings noted above and to continue     studies into the new area of epigenetics and aging.   "
183268|NCT00242268|"     The purpose of this study is to determine if using Avonex in combination with Zocor is a safe     and effective therapy for subjects with relapsing remitting multiple sclerosis.   "
183269|NCT00242281|"     The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg     tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250     mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the     Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb)     population.   "
183270|NCT00242294|"     The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function     in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be     administered orally once daily. The study duration consists of a baseline period (4 weeks)     and a treatment period (24 weeks). The study will provide further data on safety,     tolerability, and effectiveness of roflumilast.   "
183271|NCT00242307|"     The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function     in patients with asthma. Roflumilast will be administered orally once daily. The study     duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The     study will provide further data on safety, tolerability, and effectiveness of roflumilast.   "
183272|NCT00242320|"     The aim of the study is to compare the effect of roflumilast on lung function in patients     with COPD. Roflumilast will be administered orally once daily in the morning at one dose     level. The study duration consists of a baseline period (4 weeks) and a treatment period (12     weeks). The study will provide further data on safety and tolerability of roflumilast.   "
183273|NCT00242333|"     The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237     in patients with chronic obstructive pulmonary disease (COPD).   "
183274|NCT00242346|"     The purpose of this study is to assess the effects of high doses of candesartan cilexetil and     also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction     of proteinuria.   "
183275|NCT00242359|"     Management of animal induced occupational asthma is mainly avoidance, but this is not     feasible for many occupations. Treatment with avoidance and conventional treatment is also     not always successful. Omalizumab is FDA approved for the treatment of allergic asthma and     may be effective at reducing symptoms and disease progression in the animal handlers     population.   "
183276|NCT00242372|"     This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of     tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin     (along or in combination with one or more oral antidiabetic agents in addition to diet and     lifestyle advice). The study comprises a 3-week enrollment period and a 24-week randomized,     double blind, multi-center, placebo-controlled treatment period and a 3-week follow-up.     Patients must receive at least 30 units of insulin per day and will continue their current     oral antidiabetic treatment regimen throughout the study.   "
183277|NCT00242385|"     The primary purpose of this study is to characterize the pharmacokinetic profile of     intravenous Aralast Fraction (Fr.) IV-1, a sterile, stable, lyophilized preparation of     functionally intact human Alpha1- Proteinase Inhibitor (α1-PI). This pharmacokinetic study     will be a randomized controlled clinical trial with a cross-over design. Twenty-four subjects     will be enrolled into the study. Overall study duration will be approximately 6-8 months.   "
183278|NCT00242398|"     The purpose of this study is to determine the safety and operative efficacy of intermittent     hemodialysis without anticoagulation with saline flushes or Nephral 400ST in patients at high     risk of bleeding   "
183279|NCT00242411|"     The purpose of the study is to compare the efficacy of a flexible dose of Symbicort     (budesonide/formoterol) with conventional stepwise best standard treatment in patients with     persistent asthma.   "
183280|NCT00242424|"     Study of the safety and immunogenicity (antibody producing capability) comparing inactivated     influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive     inactivated influenza vaccine at the same time as other vaccines on the routine immunization     schedule. Infants will be randomized at enrollment to receive inactivated influenza vaccine     or placebo at a 2:1 ratio. This study is double-blind, randomized, and placebo-controlled.   "
183282|NCT00242450|"     During the first 7 days of life very small babies will receive the drug metoclopramide or a     salt solution through an intravenous line. They will also begin to receive a very small     amount of breast milk or formula within the first 72 hours of life, in addition toother     nourishment that is provided by an intravenous line, according to standard hospital     procedure. We think that the babies who receive the medication may reach full oral feeds than     babies who receive the salt solution.   "
183283|NCT00242463|"     This prospective, double-blinded study will determine the feasibility of determining the     efficacy of a weekly intramuscular injection of nandrolone (an anabolic steroid) in     malnourished ICU patients.The data from this study will also enable us to prepare a future     grant proposal with a calculated sample size necessary to demonstrate an improvement in     clinical outcome.   "
183284|NCT00242476|"     This study will assess the effectiveness of an investigational drug in elderly subjects with     low vitamin D levels.   "
183285|NCT00242489|"     The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the     treatment of osteoarthritis of the knee.   "
183286|NCT00242502|"     The primary objective will be to assess progression-free survival (PFS) measured at 16 weeks     following initiation of therapy with the combination of Avastin and erlotinib in patients     with unresectable hepatocellular carcinoma (HCC). Progression-free survival is defined as the     time from initiation of therapy until documented disease progression or death.      Secondary objectives include: response rate, median and overall survival, toxicity and     tolerability, and to ascertain whether there is any correlation of response with prior     treatment status and underlying HCC risk factor(s).   "
183287|NCT00242515|"     Primary Objectives:      This a pilot project to determine the feasibility of the preemptive CD8+ depleted T-cell     donor lymphocyte infusion (DLI) in:        -  Reducing the incidence of graft versus host disease (GVHD) based on standard          classification of acute and chronic GVHD        -  Improving hte disease remission rate in comparison with our previous study results.      Secondary Objectives:        -  To investigate the impact of CD8+ depleted T-cell DLI in hematopoietic chimerism, and          immunologic recovery of transplant patients.   "
183288|NCT00242528|"     To evaluate the safety and tolerability of intravenous zoledronic acid in the treatment of     patients with multiple myeloma stage III with bone lesions related to Cancer.   "
183289|NCT00242541|"     The purpose of this study is to evaluate the efficacy of octreotide acetate to decrease GH     and IGF-I levels in acromegalic patients, with microadenomas (≤ 10 mm) or macroadenomas (> 10     mm).   "
183290|NCT00242554|"     To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability   "
183291|NCT00242567|"     This study aims to determine whether early treatment with zoledronic acid, that is given     during the early phase of advanced prostate cancer, will be more efficacious than delayed     treatment   "
183292|NCT00242580|"     To evaluate the safety and efficacy of the combination treatments in wet age-related macular     degeneration. The combination treatment consists of verteporfin photodynamic therapy and     either triamcinolone acetonide or pegaptanib added as an intravitreal injection.   "
183293|NCT00242593|"     The purpose of this study is to determine the effects of the insulin-sensitizing medication     rosiglitazone on attention and memory skills in older adults with mild cognitive impairment     (MCI). The study also will examine the effects of this medication on brain structures that     support memory and other thinking abilities, and on biological markers associated with     inflammation, insulin resistance, and cardiovascular disease.   "
183294|NCT00242606|"     The purpose of this study is to compare the efficacy, safety and tolerance of the drugs     Lamotrigine and Levetiracetam in the initial monotherapy of patients with newly diagnosed     epilepsy.   "
183295|NCT00242619|"     Insulin resistance is known to be associated with mood disorders and cognitive difficulties.     The purpose of this study is to treat depressed patients with rosiglitazone (also known as     [AKA] Avandia), therefore improving glucose sensitivity, which in turn has the potential to     affect mood and thinking. We, the researchers at Stanford University, are recruiting men and     women who have been diagnosed with depression, and are willing to participate in this 3 month     study. Participation involves neuropsychological testing, 2 blood draws called an oral     glucose tolerance test (OGTT), which tests for glucose and insulin levels, and the     medication, rosiglitazone. Participants are allowed to continue on their current psychiatric     medication.   "
183296|NCT00242632|"     This research aims to explore the effectiveness of memantine (Namenda) in treating     post-menopausal women between the ages of 50 and 65, who are at risk for cognitive decline.     Memantine has already been shown to offer cognitive benefits to patients suffering from     Alzheimer's disease, but it's potential for treating those at risk for cognitive decline     without Alzheimer's disease or other dementia has yet to be evaluated. It is possible that     memantine may offer neurocognitive benefits to this population, as well. Participants are     asked to take medication for six months, complete neuropsychological testing, and one blood     draw.   "
183297|NCT00242645|"     To test whether or not giving patients information before their doctor visits changes the     care they receive and what type of information is best to give before the doctor visit.   "
183298|NCT00242658|"     This study will test the efficacy of providing primary care physicians and their patients     with computer-tailored information, based on patients' responses to survey questions. The     health education messages are designed to encourage patients to become physically active and     to encourage physicians to counsel their patients about exercise.   "
183299|NCT00242671|"     The twilight phase between being asleep and awake during recovery from anesthesia is a     precarious time fraught with risks to the post-operative patient. Hyperventilation     accelerates the elimination of inhaled anesthetics but reduces their CO2 blood concentrations     which delays their resumption of spontaneous breathing. We previously showed that our method     of hyperventilation without affecting the CO2 concentration--which we call IH--accelerates     the rate of emergence from anesthesia with isoflurane. In this study we will study the effect     of IH on the rate of emergence from Sevoflurane anesthesia.   "
183338|NCT00243087|"     RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in treating     patients with refractory or relapsed advanced non-Hodgkin's lymphoma.   "
183300|NCT00242684|"     Background: There is tremendous controversy regarding the adequacy/effectiveness of the     nutritional care provided in VA Transitional Care Units (TCUs). The interrelationship between     concurrent inflammatory disease, the adequacy of a resident's nutrient consumption, the     development or resolution of putative nutritional deficits, and clinical outcomes is not     established. Given the known obstacles to increasing nutrient intake (e.g. cost, resident     acceptance, associated morbidity) and the lack of proven effectiveness of all forms of     nutrition support and nutritional supplementation to improve clinical outcomes, a better     understanding of these interrelationships is needed and will be the focus of this study.      Objectives: The primary objective of this study is to determine how best to define     nutritional risk (i.e., risk for adverse clinical outcomes due to inadequate nutrient intake)     among older VA TCU residents. As part of this objective, we will seek to develop a better     understanding of the interrelationship between nutrient intake, weight change, serum     concentration of albumins, health status/illness severity, and mortality. The secondary     objective is to develop a prediction model for identifying which TCU residents are likely to     have ongoing problems with low nutrient intake. The ultimate objective is to develop a     clinically useful system to identify residents who are likely to benefit from specific     interventions aimed at improving nutritional risk.   "
183301|NCT00242697|"     Use of neuraxial agents in anesthesia for cardiac surgery is expanding. We have used combined     general-spinal anesthesia for cardiac surgery for 12 years. We hypothesized that compared to     general anesthesia, the combined techniques would provide comparable intraoperative     hemodynamics and improved postoperative analgesia. This study subjected these techniques to a     double-blind randomized trial.   "
183302|NCT00242710|"     The purpose of this study is to determine whether bazedoxifene/conjugated estrogens     combinations are effective for the prevention of endometrial hyperplasia and for the     prevention of osteoporosis in postmenopausal women.   "
183303|NCT00242723|"     Background:        -  Chromatin is is the structural building block of a chromosome. It is found inside the          nucleus of the cell and consists of a complex of DNA and protein.        -  Cancers of the lung, pleura (lung lining) and esophagus show profound changes in          chromatin structure that may affect the course of disease in patients.        -  A better understanding of these diseases and the genetic changes associated with them          may be helpful in developing new treatments for them.      Objectives:        -  To evaluate people with cancer of the lung, pleura or esophagus for participation in NCI          clinical trials.        -  To obtain biopsies (small pieces of tissue) from tumor, normal tissue and blood samples          to learn more about the cellular changes in blood and tissue in tumors of the lung,          esophagus and pleura and surrounding structures in the chest.      Eligibility: Patients 18 years of age and older with cancer of the lung, esophagus, pleura,     mediastinum or chest wall, or cancers of other origin that have invaded the lung.      Design:        -  Up to 800 patients may be included in this study.        -  Patients undergo standard tests for evaluating the stage of their disease and for          determining eligibility for an NCI investigational treatment study.        -  All patients undergo bronchoscopy and bronchoalveolar lavage (washing with salt water)          to assess their tumor and collect a sample of normal tissue. Patients whose tumor is          located on the outside portion of the lung may also undergo thoracoscopy to obtain a          tumor sample. For bronchoscopy and bronchoalveolar lavage a tube with a light is passed          through the nose or mouth into the lungs to examine the airways. Salt water is injected          through the tube and then withdrawn to obtain cells for laboratory studies. For the          thoracoscopy a small tube with a light is put through a small hole in the chest to          obtain the tumor sample. Both procedures are usually done under general anesthesia. The          tissue is examined to identify cell characteristics of people who respond to certain          therapies and to identify markers on the surface of the tissue that may be useful in          future research and treatment.        -  Blood and urine samples are collected from patients.        -  Patients who are eligible for a treatment study at NCI are offered participation in the          study.        -  Patients for whom standard surgery, radiation or chemotherapy is more appropriate may          receive treatment at NCI or with their own physician.        -  Patients who receive treatment at NCI return for follow-up examinations 4 weeks after          discharge and then every 2 to 4 months depending on the nature of their cancer.   "
183304|NCT00242736|"     The purpose of this study is to evaluate whether there is a difference in proportion of     patients with resolution of heartburn and other symptoms related to gastroesophageal reflux     disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects     with Erosive Esophagitis (EE) and those without EE.   "
183305|NCT00242749|"     · To evaluate the disease free survival rate at 2 years of patients with advanced head and     neck carcinoma treated with ZD1839 250 mg administered once daily in combination with     cisplatin and a standard course of radiotherapy.   "
183306|NCT00242762|"     The primary objective of the study is to evaluate the activity of the combination ZD1839,     docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by     estimating the objective response rate (complete response [CR] and partial response [PR]) at     study closure.   "
183307|NCT00242775|"     The purpose of this study is to compare the efficacy and safety of a variable dose of     Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the     treatment of asthma.   "
183308|NCT00242788|"     The primary objective of the Phase I part of the study is to determine the recommended dose     of capecitabine to be administered in combination with ZD1839 250 mg orally once daily in     subjects with advanced or metastatic colorectal cancer by assessing DLTs.      The primary objective of the Phase II part of the study is to estimate the objective response     rate (complete response [CR] and partial response [PR]) at study closure for ZD1839     administered in combination with capecitabine in subjects with advanced or metastatic     colorectal cancer using the Response Evaluation Criteria in Solid Tumours (RECIST).   "
183309|NCT00242801|"     This study is being carried out to see if adding ZD1839 to other standard supportive care is     more effective than standard supportive care alone for the treatment of patients with NSCLC     whose disease has recurred after previous chemotherapy treatment.   "
183310|NCT00242814|"     The objective of the study is to compare PPAR activities (increase of adiponectin level)     between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with     metabolic syndrome. Moreover, this study will compare serum level of inflammatory markers of     the metabolic syndrome after 6 weeks of treatment.      An ancillary study performed in one center will assess adipocyte differentiation (PPAR gamma     stimulation) in 30 subjects (15 per arm).   "
183311|NCT00242827|"     An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients     with Advanced Multiple Myeloma.   "
183312|NCT00242840|"     This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy     in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908     (fosamprenavir)-containing regimen.   "
183339|NCT00243100|"     This phase I trial is studying the side effects and best dose of vorinostat and gemcitabine     in treating patients with metastatic or unresectable solid tumors. Drugs used in     chemotherapy, such as vorinostat and gemcitabine, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may     also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth     and by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy)     may kill more tumor cells.   "
183313|NCT00242853|"     This study is being conducted to validate various biomarkers in patients with RA with varying     levels of disease severity. Subjects with a diagnosis of rheumatoid arthritis (RA) will be     included as controls. The sudy will measure the baseline levels and the intra- and     inter-subject variability of exhaled nitric oxide (NO) in patients with inactive/mild and     moderate/severe RA on stable therapy or during a course glucocorticoids. In addition exhaled     NO levels will be correlated with intra-articular inflammation (power Doppler     ultrasonography) as well as markers of systemic inflammation (CRP, ESR).   "
183314|NCT00242866|"     Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric     oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of     NOS, and therefore NO, may be an effective technique for the prevention of migraine headache.     GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory     activity in migraine through a novel mechanism of action. The intent of this study is to     investigate the safety and efficacy of GW274150 for the prophylactic treatment of migraine     headache.   "
183315|NCT00242879|"     This is a two phase study (randomised and non-randomised phase). The randomised phase will     initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current     background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor     (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy.     Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of     the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on     resistance testing at screening. Subjects will remain in the randomized phase on one of these     4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the     randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies.     After dose selection subjects will move to the non-randomised phase of the study. In the     non-randomised phase subjects who are receiving GW640385 will be assigned to final selected     dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral     activity.   "
183316|NCT00242892|"     Hypothesis : it is known that the stent must be well opened out in order to avoid restenosis     into the stent. Intra coronary pressure would allow the stent to be well deployed and so the     restenose into the stent should diminish.      Primary purpose : this study intend to test the hypothesis of optimal spreading of coronary     stent guided with pressure into coronary arteritis comparing 2 strategies with patients     having a coronary procedure with stent, excluded patients with myocardial infarction.   "
183317|NCT00242905|"     Memory is a cognitive function whose development is still poorly documented in children, but     which is often disturbed in temporal epilepsy. There are no studies about the disorders of     episodic memory. The investigations using functional MRI (fMRI) are scarce, they do not     involve this field and none are dedicated to children. The objectives of this project are to     study the neuronal networks involved in episodic memory in normal children, as well as the     disorders of episodic memory in children with epilepsy and the mechanisms of cognitive and     cerebral reorganization in epilepsy.   "
183318|NCT00242918|"     The purpose of this study is to determine the safety and effectiveness of the combination of     docetaxel and ZD1839 on destroying prostate cancer before removal of the prostate.   "
183348|NCT00243217|"     The objective of this trial is to demonstrate clinical efficacy of four different dosages of     SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15     cm2 patch size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936)     will be more effective than placebo. The tolerability and safety of rotigotine will be     assessed.   "
183319|NCT00242931|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy     before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the     patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune system and help destroy any remaining cancer cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving cyclosporine and mycophenolate     mofetil after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body     irradiation works in treating patients who are undergoing a donor stem cell transplant for     progressive metastatic prostate cancer that has not responded to previous hormone therapy.   "
183320|NCT00242944|"     The purpose of this study is to compare the effects of pitavastatin and atorvastatin on     coronary plaque volume in patients with acute coronary syndrome and to clarify the     relationship between coronary plaque volume, serum lipids, and inflammation markers in order     to determine the significance of intensive lipid lowering therapy in patients with acute     coronary syndrome in Japan.   "
183321|NCT00242957|"     The IMAGE Study is a cluster randomised trial of a structural intervention for the prevention     of HIV and gender based violence being conducted in South Africa.   "
183322|NCT00235911|"     The primary objective is to compare the effects of Symbicort SiT and treatment according to     NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20     histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).   "
183323|NCT00235924|"     The main objective of this study is to determine the effects on the endometrium and breast of     70 mg daily dose of isoflavones.   "
183324|NCT00235937|"     The purpose of this study is to determine the efficacy and tolerance of the association of     two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and     Zoladex® 3,6 Mg in injections under cutaneous once per month in subjects with breast cancer.   "
183325|NCT00235950|"     The purpose of this study is to compare the efficacy between two lipid lowering treatments,     rosuvastatin (10-40 mg) and atorvastatin (20-80 mg) in reducing low-density lipoprotein     cholesterol (LDL-C) levels after 16 weeks of treatment in patients with coronary heart     disease   "
183326|NCT00235963|"     To determine whether HMG-CoA reductase inhibitor simvastatin prevents or ameliorates     subarachnoid hemorrhage-induced delayed vasospasm and its ischemic consequences.   "
183365|NCT00243984|"     The purpose of this study is to evaluate the efficacy of topiramate compared to placebo in     the treatment of obesity in metabolic syndrome. Secondary objectives include topiramate and     weight loss effects on lipid levels, HbA1C, insulin resistance, and blood pressure.   "
183327|NCT00235976|"     This is a multicenter, randomized, controlled, observer-blinded, dose-response study to     evaluate the efficacy in tracheal intubation and safety of gantacurium chloride for injection     in healthy adult patients undergoing surgery with general anesthesia.      Gantacurium chloride for injection (previously referred to as AV430A) is a new,     investigational non-depolarizing ultra-short acting neuromuscular blocking agent (NMB).     Preliminary results in animals and healthy human subjects (Phase 1 studies in adult     volunteers) suggest that gantacurium chloride for injection may provide a useful adjunct to     general anesthesia by permitting rapid intubation. This Phase 2 study will provide more     definitive information on the ultra-short acting profile of the compound by determining the     quality of intubation in patients, at 60 seconds, as assessed by a blinded intubator. In     addition, the safety of the compound will be assessed. In this study, the efficacy and safety     of gantacurium chloride for injection will also be compared to a reference drug,     succinylcholine, and to placebo.      The primary objective of this study is to determine the dose-response relationship of     gantacurium chloride for injection on tracheal intubation conditions after a single rapid     bolus intravenous (i.v.) dose as a component of a propofol/opioid induction-intubation     sequence and to assess the safety profile of this compound.   "
183328|NCT00235989|"     The purpose of this study is to determine if a higher dose of study drug is more effective in     preventing relapses in patients with Multiple Sclerosis.   "
183329|NCT00242970|"     Subjects with a burn to the face and/or neck will be enrolled into the study and a     Three-Dimensional scanner used to see if it can objectively measure scar color and volume and     measure the effect of scar on motion of the face and neck.   "
183330|NCT00242983|"     RATIONALE: Studying quality-of-life in patients undergoing cancer treatment may help identify     the intermediate and long-term effects of treatment on patients with cancer.      PURPOSE: This clinical trial is studying quality of life in patients who are receiving either     vinorelbine, gemcitabine, and docetaxel or paclitaxel and carboplatin for advanced non-small     cell lung cancer.   "
183331|NCT00242996|"     RATIONALE: Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as     rituximab, and chemotherapy, such as cyclophosphamide, helps stem cells move from the     patient's bone marrow to the blood so they can be collected and stored for peripheral stem     cell transplant. Giving chemotherapy, such as carmustine, etoposide, and cyclophosphamide,     before transplant stops the growth of cancer cells by stopping them from dividing or killing     them. The stem cells are then returned to the patient to replace the blood-forming cells that     were destroyed by the chemotherapy. More rituximab is given after transplant to kill any     remaining cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with     cyclophosphamide and G-CSF followed by combination chemotherapy works in treating patients     undergoing an autologous stem cell transplant followed by rituximab and GM-CSF for refractory     diffuse large B-cell lymphoma.   "
183332|NCT00243009|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy     before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the     patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune system and help destroy any remaining cancer cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving cyclosporine and mycophenolate     mofetil after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body     irradiation works in treating patients who are undergoing a donor stem cell transplant for     metastatic kidney cancer that cannot be removed by surgery.   "
183370|NCT00244062|"     The study proposes to test the efficacy of a primary care-based brief intervention with women     who resumed heavy drinking during the post-partum period and who used alcohol during a     previous pregnancy. The trial will also examine the effects of tobacco use, illicit drug use,     depression and domestic violence on alcohol use.   "
183333|NCT00243022|"     RATIONALE: Giving the herb Boswellia serrata after surgery and radiation therapy may slow the     growth of any remaining tumor cells. It is not yet known whether giving Boswellia serrata     together with standard treatment is more effective than standard treatment alone in treating     high-grade gliomas.      PURPOSE: This randomized phase II trial is the study of a combination of complementary and     alternative medicine (CAM) herbal supplement intervention as an adjuvant to standard     treatment of patients with newly diagnosed and recurrent high-grade gliomas (HGG). The     central hypothesis of this application is that a herbal preparation that inhibits 5-LO     activity, will produce measurable biologically meaningful decrease in 5-LO eicosanoid     production and brain edema that will be associated with improved survival and quality of life     in patients with HGG.   "
183334|NCT00243035|"     This phase I/II trial is studying the side effects and best dose of tipifarnib when given     together with bortezomib and to see how well they work in treating patients with relapsed     multiple myeloma. Tipifarnib and bortezomib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Giving tipifarnib together with bortezomib may     kill more cancer cells.   "
183335|NCT00243048|"     RATIONALE: Eating a diet high in soy foods may slow the progression of some types of cancer.     Isoflavones are compounds found in soy food that may slow the growth of prostate cancer cells     and prevent further development of prostate cancer. Radiation therapy uses high-energy x-rays     to kill tumor cells. Giving isoflavones together with radiation therapy may be an effective     treatment for prostate cancer.      PURPOSE: This randomized phase II trial is studying the side effects and how well giving     isoflavones together with radiation therapy works in treating patients with localized     prostate cancer.   "
183336|NCT00243061|"     This phase II trial is studying how well AZD2171 works in treating patients with recurrent or     stage IV melanoma. AZD2171 may stop the growth of tumor cells by blocking blood flow to the     tumor and by blocking some of the enzymes needed for cell growth.   "
183337|NCT00243074|"     This phase II trial is study how well AZD2171 works in treating patients with malignant     pleural mesothelioma that cannot be removed by surgery. AZD2171 may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to     the tumor   "
183381|NCT00244205|"     To investigate the methylation status of 4-6 genes in Urine and matching bladder tissue     biopsies, in order to find methylation markers for use in a noninvasive test in monitoring     patients with bladder tumors.   "
183340|NCT00243113|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving docetaxel together with     radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation     therapy works in treating patients with stage II or stage III cancer of the larynx or     hypopharynx.   "
183341|NCT00243126|"     This is an exploratory/developmental study to support the early phases of development and     evaluation of a family-based HIV prevention program for adolescent girls prior to a     full-scale trial. Research on the new intervention will include evaluating the feasibility,     tolerability, and acceptability of the intervention, and allow us to obtain the preliminary     data needed as a pre-requisite to a larger-scale intervention study.      Adolescent females and their mother/guardian will be randomized to either: a family-based     risk reduction intervention; or a no-treatment control group condition. Participants in both     conditions will be assessed at baseline, immediate post-intervention, and at 3- and 6-month     follow-ups. A subset of families (12 adolescents and 12 mothers) will participate in a     qualitative interview following the 6-month follow-up, in which information will be obtained     on participant perception of procedures and intervention content, and whether they have     utilized skills taught following the end of the project.   "
183342|NCT00243139|"     The purpose of this study was to determine how effective a custom-made standard dental splint     (activator) advancing the lower jaw forward is in treatment of obstructive sleep apnea, and     further to find factors for identification of those patients likely to benefit from this     treatment.   "
183343|NCT00243152|"     The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine     (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic     resonance imaging (fMRI).   "
183344|NCT00243165|"     This study will include 60 patients with early breast cancer referred to receive adjuvant     chemotherapy with AC ( adriamycin- cyclophosphamide) or CAF ( adriamycin- cyclophosphamide-     5- fluorouracil ) combinations. These patients will receive every day one spoon of Lifemel     honey or regular honey ( double blind)- during the adjuvant chemotherapy .Every week a WBC     count will be performed in order to record the influence of Lifemel on myelotoxicity.   "
183345|NCT00243178|"     The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily     (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation     therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at     least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel     plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a     vitamin K antagonist) will result in the same risk of the composite outcome of stroke,     non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial     fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel     has a lower risk of hemorrhage than standard anticoagulation therapy.   "
183346|NCT00243191|"     The purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma     protuberan tumors.   "
183347|NCT00243204|"     This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus     placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy     regimen.   "
183349|NCT00243230|"     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells     that fight infection). The purpose of this 48-week study is to evaluate 2 dose levels of     vicriviroc in HIV patients who have not responded adequately to standard HIV treatments. This     study was designed to evaluate these doses of vicriviroc, when taken in combination with     other appropriate HIV drugs, in terms of ability to decrease the level of HIV (viral load) in     the blood and safety   "
183350|NCT00243243|"     The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or     NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower     the amount of blood lost during burn surgery.   "
183351|NCT00243256|"     The purpose of the study is to evaluate if supplementation with vitamin D in doses of     20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as     compared to placebo during 1 year.   "
183352|NCT00243269|"     This study hypothesizes that patients receiving efficacy enhancing information about the     acupressure bands will expect less treatment-related nausea, which will subsequently result     in less treatment-related nausea compared to patients who do not receive such information.      This study extends prior research by utilizing a randomized controlled trial in a clinical     environment to examine the efficacy of an intervention that is specifically designed to     reduce patients' response expectancies concerning nausea development from cancer treatments,     and, thereby, reduce nausea.      The objectives of this study are as follow:        1. To provide preliminary data on whether a two-tiered strategy to increase patients'          expectancies for nausea prevention and/or management will result in reduced          chemotherapy-induced nausea.        2. To provide preliminary data on whether a two-tiered strategy to increase patients'          expectancies for nausea prevention and/or management will result in increased          health-related quality of life (HRQL) in patients receiving emetogenic chemotherapy.      To provide preliminary data on whether a two-tiered strategy to increase patients'     expectancies for nausea prevention and/or management is more effective than a single-tiered     strategy in reducing chemotherapy- induced nausea.   "
183366|NCT00243997|"     The primary aim of this study is to test the effectiveness of the Becoming Parents Program--a     couple focused educational program for couples having a first child--on individual and couple     well being and the parent-infant relationship over the first three years of parenthood.      Other aims of this study are to evaluate the cost of implementing the Becoming Parents     Program; to describe changes in individual and couple well-being over time, viewing the     transition to parenthood from a developmental perspective using data from the control group;     examine the various variables in the study over time from pregnancy through three years     post-birth.   "
183382|NCT00244218|"     The purpose of this study is to determine whether tetrahydrobiopterin (BH4)is effective in     treating patients with PKU.   "
183353|NCT00243282|"     Dyspnea (shortness of breath) is a complex experience that includes interpretation of     physical impairments and associated distress to the person. The role of mind-body     interactions in the experience of the symptom of dyspnea suggests that complementary and     alternative medicine (CAM) therapies may be effective in abating dyspnea and improving     patients' health-related quality of life. CAM strategies work in a number of ways that are     directly applicable to dyspnea, such as decreasing the stress response, inducing relaxation,     and facilitating a less distressful interpreted experience of physical disorders.      We have combined a number of established CAM approaches aimed at breath-centered mindfulness     and relaxation into an single therapy, mind-body breathing therapy (MBBT). The purpose of     this study is to test the efficacy of MBBT in improving dyspnea and health-related quality of     life for patients with emphysema (chronic obstructive pulmonary disease).   "
183354|NCT00243295|"     To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic     studies, with assessment of the following parameters:        -  Injecting the desired volume of rhBMP-2/CPM within the defect        -  Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence          of rhBMP-2/CPM.   "
183355|NCT00243854|"     To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy     concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva)     in the treatment of patients with resectable pancreatic cancer.   "
183356|NCT00243867|"     The primary objective of this trial is to compare the survival of patients with advanced     non-small cell lung cancer (NSCLC) treated with weekly Taxoprexin in combination with     carboplatin to those treated with paclitaxel plus carboplatin in a prospectively randomized     trial. In addition, the response rate to each regimen, response duration, time to progression     and time to treatment failure will be measured. Toxicity will be evaluated and compared     between the two groups.   "
183357|NCT00243880|"     The purpose of this dose escalation study is to evaluate the use of lovastatin for the     treatment of acute ischemic stroke.   "
183358|NCT00243893|"     The purpose of this pilot study is to investigate the use of minocycline and doxycycline as     medical therapy for inoperable or partially treated arteriovenous malformations (AVMs) and     giant aneurysms.   "
183359|NCT00243906|"     The purpose of this study is to examine the effects of delivering intra-arterial recombinant     tissue plasminogen activator (rt-PA) and ultrasound to the site of the blood clot blocking     blood flow to the brain of stroke patients.   "
183360|NCT00243919|"     The purpose of this study is to compare two different treatments to improve walking after     stroke (or post-stroke).   "
183361|NCT00243932|"     The purpose of this study is to determine the efficacy and preferred dose of CoQ10 in     individuals with ALS for a possible future phase III study.   "
183362|NCT00243945|"     The objective of this trial is to assess the effect of rotigotine (SPM 962) on the control of     early morning motor impairment and sleep disorders in subjects with idiopathic PD.      Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal     patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose.     Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or     maximal dose for 4 weeks. After the Maintenance period, subjects will have the option to     enter into an open-label extension study.      The first subject was enrolled in December 2004. The last subject was enrolled in April 2005     and the last subject visit was conducted in July 2005. This study is now closed   "
183371|NCT00244075|"     The goal of this study is to evaluate the metabolic effects of concomitant use of three     consecutive doses of recombinant human growth hormone over three days and exercise during     continuous nutrient infusion in chronic hemodialysis patients. We would also like to evaluate     the metabolic effects of nutritional supplementation alone without the additional anabolic     strategies.   "
183372|NCT00244088|"     The aim of this study is to define the etiology of intra-abdominal infections, to study the     role of Enterococcus spp and Pseudomonas aeruginosa in these infections and to clarify the     need for specific enterococcal antimicrobial coverage.   "
183363|NCT00243958|"     Hearing impairment either clinical or subclinical is a characteristic of some renal disease     patients. The hearing impairment could be result from specific etiologies or chronic renal     failure itself. The causes of hearing impairment in renal disease patients ranged from drugs     intoxication in both auditory and renal function, like gentamycin or isoniazid, congenital     disease like Alport syndrome or other collagen-defective renal disease, or just aging     related. End-stage renal disease (ESRD) patients are special in many parts to general     population who have hearing impairment. First, inflammation in ESRD patients is     well-documented, second, they suffered from various underlying diseases which auditory     function was potentially impaired, third, they need to undergo renal replacement therapy     either hemodialysis (HD) or peritoneal dialysis (PD) to maintain their life. Dialysis itself     was found to be a cause of hearing impairment, too. The biochemical change and constitutive     inflammation status are thought to be implicated in the pathogenesis of hearing impairment in     ESRD patients. Aluminum (Al) is a well-documented heavy metal, which predisposes to     Alzheimer’s disease, dementia or some neurologic diseases. Al intoxication is very rare in     general health population but elevated serum Al level is easily found in ESRD patients since     they can not excrete Al by damaged kidneys and dialyzers. Inner ear per se is a neurologic     tissue, so if serum Al level in ESRD patients has any association in their haring function     needs to be studied.   "
183364|NCT00243971|"     The objective of this trial is to compare the effect of rotigotine (SPM 962) and ropinirole     on the control of early morning motor impairment and sleep disorders in subjects with     early-stage PD.      Subjects who meet eligibility criteria will be randomly assigned either to rotigotine     transdermal patch or ropinirole tablets. Trial medication will be titrated for rotigotine and     ropinirole until an individual optimal dose is achieved. Following a Titration period of up     to 4 weeks in the rotigotine arm and 6 weeks in the ropinirole arm, subjects will be     maintained on the optimal or maximal dose for 4 weeks. At the end of the Maintenance period,     subjects will be given the opportunity to enter a 2-year rotigotine patch extension trial.      The first subject was enrolled in December 2004. The last subject was enrolled in June 2005.     Last subject out is expected for October 2005. The trial is still ongoing.   "
183383|NCT00244231|"     To assess the efficacy and safety of Nidadd (extended-release niacin) in patients with     hyperlipidemia.   "
183367|NCT00244010|"     Due to an overall and disease free survival of 85% to 100%, allogeneic blood or bone marrow     stem cell transplantation using an HLA matched sibling donor is the therapy of choice for     patients with severe aplastic anemia (SAA). Unfortunately, only about 25% of patients have     such a donor. For patients with SAA lacking a matched sibling donor, immunosuppressive     therapy is the current treatment of choice. Approximately 70% of these patients have a     complete or partial response to immunosuppressive therapy, achieving transfusion independence     and/or growth factor independence.      For the approximately 30% of patients who do not respond to immunosuppressive therapy or     experience recurrence, alternative donor (matched unrelated, partially matched family member)     transplantation is a treatment option. However, graft rejection and graft-versus-host-disease     (GVHD) are significant barriers to success, decreasing event-free survival to 30% to 50%.      This study offers stem cell transplantation using a partially matched family member     (haploidentical) donor to those patients with no available HLA-matched sibling or matched     unrelated donor. In an attempt to reduce GVHD and regimen-related toxicity while maintaining     adequate engraftment, we plan to infuse a highly purified stem cell graft. The Miltenyi     Biotec CliniMACS CD3 depletion system will be used to derive a defined allogeneic graft     highly enriched for CD34+ hematopoietic cells and depleted of CD3+ T-lymphocytes from G-CSF     mobilized, donor-derived peripheral blood stem cells.      Patients 21 years of age and younger with refractory cytopenias are also eligible for this     protocol as there are no other potentially curative therapies currently available for these     conditions.      The primary objective of this study is to evaluate the safety of transplantation using a     haploidentical donor product engineered to targeted cell counts using the investigational     CliniMACS device for patients with refractory severe aplastic anemia (SAA) or refractory     cytopenias. The treatment plan would be considered unsafe if we can find this type of     procedure is associated with a significantly higher treatment failure rate. Treatment failure     is defined as any occurrence of the following events, overall grade III-IV acute GVHD, graft     failure or death due to any cause within 100 days after transplant.   "
183368|NCT00244023|"     30 to 50% of the patients presenting with Erectile Dysfunction (ED) do not respond to PDE V     Inhibitor therapy, which is presently considered as the first choice treatment for most ED     patients. Recent reports stated a high prevalence of low serum testosterone levels in such     non responders, and an improvement of their response by combining testosterone therapy with     the PDE V Inhibitor. This suggests there may be a minimum threshold level of blood     testosterone for a full effectiveness of PDE V Inhibitor therapy. Two double blind, placebo     controlled studies have added support to this hypothesis but one involved only 20 patients     while in the other the benefit of combining testosterone was transient. This is a     multi-centric study, double blind placebo controlled and randomized as concerns testosterone     administration, that aims to objectively assess the efficacy of co-administering testosterone     with the PDE 5 inhibitor Tadalafil to improve the erectile function of a large group of ED     patients non-responders to PDE V inhibitors alone. Patients will be screened to ensure     inclusion and exclusion criteria completion, including a serum testosterone level < 4 ng/ml     for total testosterone or < 1 ng/ ml for bioavailable testosterone. They will then enter a     four week run-in period in the meanwhile they will receive Tadalafil 10 mg only, once daily,     in order to confirm their non responsiveness to PDE V inhibitors and their eligibility to     enter the treatment phase based on IIEF scoring, SEP diaries and a Global Assessment Question     (GAQ). The patients still non responders after 4 weeks of Tadalafil 10 mg daily will enter a     12 weeks treatment phase including visits at weeks 4, 8, 12 and 16. Treatment procedure will     include: 1. continuation of Tadalafil at 10 mg dose daily followed by routine assessment     using SEP diaries, IIEF scoring, GAQ and Aging Male Symptoms scale administered at each study     visit. Safety assessments will be performed in addition during the last visit (physical     examination including DRE, PSA and BCC). 2. Randomization in 2 parallel arms (Placebo gel +     Tadalafil 10 mg daily, and Testosterone gel 50 mg + Tadalafil 10 mg daily). If indicated     according to suboptimal clinical response of the patient, the dose of study medication will     be increased at the 8 or 12 weeks visit to 100mg of testosterone or to 2 sachets of placebo     gel. Up to 430 patients will be screened in order that 172 are enrolled in the double blind     treatment phase.   "
183369|NCT00244049|"     The goal of the study is to test the efficacy of brief clinician advice in reducing the     frequency of high-risk drinking and alcohol-related harm in a population of college students     seeking care at five university health care clinics. High-risk drinking is defined as 1) 8 or     more episodes of heavy drinking (5 or more drinks in a row) in the past 28 days for male and     female students, and/or 2) 50 drinks for male and 40 drinks for female students in the past     28 days, and/or 3) 15 drinks for male and 12 drinks for female students in the past 7 days,     and/or 4) One or more episode(s) of heavy drinking which includes 15 or more drinks in a row.   "
185351|NCT00269854|"     The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric     monoclonal antibody (cA2) compared to placebo in patients with active Crohn's disease.   "
183373|NCT00244101|"     The best mode of delivery room stabilization for premature infants at high risk for     respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct     methods of post-delivery stabilization and subsequent early respiratory care on chronic lung     disease and survival in premature infants at high risk for respiratory distress syndrome.   "
183374|NCT00244114|"     Based on the finding that anaphylactic reactions to Benefix (FIX) are associated with a     specific IgE, a Basophil histamine release assay was selected to evaluate and demonstrate     subject sensitization to FIX.   "
183375|NCT00244127|"     To evaluate the safety and efficacy of R-COMP in elderly patients with advanced aggressive     NHL. Myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the     R-CHOP regimen.   "
183376|NCT00244140|"     This is a research study involving the use of a contrast agent called Ultravist Injection.     Ultravist, the study drug, is used to improve the pictures obtained using computed tomography     (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case     of this study, it will be injected into a vein in the patient's arm; from there, it travels     through the blood stream and to the areas to be examined. CT scans will then be taken of the     patient's head and/or body as ordered by his/her physician.      Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When     Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast     Enhanced Computed Tomography (CECT) of the Head and/or Body   "
183377|NCT00244153|"     Intraarticular application of opioids versus glucocorticosteroids versus placebo in knee     arthritis      study goals: assessment of effectiveness and tolerability of locally applied morphine,     dexamethasone or placebo in knee arthritis   "
183378|NCT00244166|"     1. to investigate whether steroids are effective in ankylosing spondylitis        2. if steroids are effective to describe how quick they work   "
183379|NCT00244179|"     1. to investigate, whether one of the two alternative therapy strategies (antibiotic plus          immunostimulation versus antibiotic plus immunosuppression) in chronic reactive          arthritis is therapeutical superior to conventionel standardtherapy (DMARD).        2. to investigate, whether one or more of the different therapy strategies cause an altered          detection of bacterial DNA in the joint or colon.        3. to measure the antigen-specific and -unspecific immune response (predominantly t-cell          response) during therapy and correlate it with the clinical course.        4. to gain knowledge from these analyses and the clinical course concerning the          pathogenesis and the point of attack for possible therapies in chronic reactive          arthritis.        5. to compare cytokine-profiles of CD4- and CD8-positive T-cells from patients treated with          infliximab to those treated with etanercept.   "
183380|NCT00244192|"     The purpose of this study is to determine whether infliximab is effective on fat-free mass in     the treatment of patients with moderate to severe COPD suffering from cachexia.   "
183384|NCT00244244|"     The primary purpose of this study is to evaluate the safety and tolerability of arimoclomol     in ALS patients following 90 days of dosing. In addition, the amount of arimoclomol in blood     and cerebrospinal fluid will be measured.   "
183385|NCT00244257|"     This study is designed to investigate the safety of a single infusion of GMA161 in patients     with idiopathic thrombocytopenic purpura, as well as, the way the drug enters and leaves the     body. In addition, throughout the study, platelet counts and other blood cell numbers will be     measured. NOTE: A decision was made to terminate this study in June 2008 due to low     enrollment.   "
183386|NCT00244270|"     The purpose of this study is to evaluate the incidence of venous thrombosis occurring on     totally implantable vascular access devices in cystic fibrosis patients who need a new device     (it can be the first one or a subsequent one) and to study the genetic risk factors of     thrombosis adjusted to the acquired ones.      It is a nationwide cohort study planned for two years with a six month follow up period. The     expected number of inclusion is 50 patients each year, that is to say 100 for the whole     study.      In cystic fibrosis, pulmonary exacerbations necessitate repeated intravenous antibiotics, but     the peripheral blood accesses become precarious with time, leading to the indication of a     central venous device. It is important to take a lot of precautions to protect vascular     access. This allows the patient to have a dramatic improvement in life expectancy with such     life-long devices (ONM, French National Observatory France 2003 : median at 36 years). Venous     thrombosis can cause a superior cava syndrome, a pleural effusion or a pulmonary embolism.     The risk of thrombosis is significant; retrospectively, it has been evaluated to be between 4     and 16% in the publications. This rate may be higher due to the fact that venous thrombosis     may remain asymptomatic, and therefore silent, but they lead to the same risk of vascular     access loss.   "
183387|NCT00244283|"     To compare two different methods of protecting heart muscle from damage caused by a decreased     blood supply. Exposure to the anaesthetic agent sevoflurane can allow the heart muscle to     resist longer periods of low blood or oxygen supply without sustaining the amount of damage     that it would otherwise expect to. The use of thoracic epidural analgesia improves the blood     flow to the heart muscle and has also been shown to reduce the amount of damage the heart     muscle may otherwise sustain. The aim of this study is to compare these two methods.   "
183388|NCT00244296|"     The purpose of this study is to determine how effective duloxetine is in treating women who     are 65 years of age or older with symptoms of stress urinary incontinence, or with a     combination of stress urinary incontinence and urge urinary incontinence symptoms.   "
183389|NCT00244309|"     The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or     another drug named dutasteride (Avodart), or a combination of these two drugs is effective in     improving urinary symptoms and decreasing the rate of intermittent self-catheterization after     prostate brachytherapy.   "
190281|NCT00336167|"     The purpose of this study is to determine whether bezafibrate is effective in the treatment     of the muscular adult form of carnitine palmitoyltransferase 2 deficiency   "
183390|NCT00244322|"     The purposes of this study are to determine:        -  The safety of LY450139 dihydrate and any side effects that might be associated with it.        -  How much LY450139 dihydrate should be given and how long it may be detected in blood.        -  To determine if LY450139 dihydrate may have an effect on a protein found in blood,          called A beta. This protein is studied in subjects with Alzheimer's disease.        -  To collect and store samples from blood and spinal fluid for research related to          Alzheimer's disease and similar (neurodegenerative) diseases or inflammation          (irritation) that may provide information on how subjects respond to LY450139 or other          medications.      Length of study: Approximately 29 weeks.      Number of office visits: 11 for most subjects: initial visit, every other week during 14     weeks of study drug treatment, and 2 follow-up visits.      At no cost, approximately 45 eligible participants will receive:        -  Study medication        -  Study-related diagnostic and laboratory evaluations   "
183391|NCT00244335|"     Post-traumatic stress disorder (PTSD) is a serious illness, in which individuals often     experience anxiety and stress. Some individuals with PTSD use drugs to alleviate emotional     distress. This study will examine the role that negative emotional states play in sedative     drug use among individuals with PTSD.   "
183392|NCT00244348|"     Hepatic artery infusion (HAI) with oxaliplatin (OX), systemic 5 fluorouracil (5FU), and     leucovorin (HAI/OX/FU) will be implemented using an interventional radiology technique to     obviate the need for initial major surgery (catheter placement) in patients who have     unresectable liver metastasis from colorectal cancer. The study goal is to reduce tumor size     to make possible a complete resection of all lesions. Secondary goals are to reduce or     eliminate the complexity usually associated with HAI, to accomplish most or all of the     treatment as an outpatient, to reduce costs, and to avoid the hepatotoxicity associated with     HAI/floxuridine (FUDR). Oxaliplatin has been selected because of its ease of use, known     toxicology, and established efficacy in colorectal cancer.   "
183393|NCT00244361|"     The purpose of this study is to reduce the symptoms of OMS by testing rituximab (Rituxan®),     to remove B lymphocytes that make antibodies and trigger brain inflammation. Evidence     suggests that autoimmune brain inflammation causes the symptoms of OMS. This study of blood     and spinal fluid intends to find out what effect rituximab has on OMS and on the spinal fluid     B-cells.      Rituximab targets and destroys B-cells, which make antibodies that can attack the brain and     cause may OMS. It is infused through a vein over a period of several hours. Rituximab has     been used widely and studied extensively since its approval in 1997 by the U.S. Food and Drug     Administration (FDA) for non-Hodgkin's B-cell Lymphoma (NHL). Today, more than 300,000     patients have received rituximab, and it is part of more than 200 completed, ongoing, or     planned clinical trials. Rituximab is not FDA-approved for OMS.   "
183394|NCT00244374|"     The purpose of this study is to compare the effects of (a) immunization setting and (b)     outreach worker support on young injection drug users' (IDU) adherence to a multiple dose     immunization schedule with a combined hepatitis A virus (HAV) inactivated and hepatitis B     virus (HBV) recombinant vaccine.   "
183465|NCT00245297|"     Primary efficacy endpoint: To study whether there is a difference in the length of the     bleeding free periods between infusion of FVIII that is reconstituted with 22.1, 12.6, or 4.2     mg of pegylated liposomes per kg bwt compared with standard formulation.      Safety endpoint: To study the safety and tolerability of Kogenate FS reconstituted with     Pegylated liposomes   "
183395|NCT00244387|"     Male and female patients aged ≥ 30 years with advanced stage idiopathic Parkinson's disease,     not well controlled on existing levodopa will take part in a research study at approximately     82 sites in Europe, Israel, South Africa, Australia and new Zealand.      The purpose of the study is to evaluate the effectiveness, safety and tolerability of the     rotigotine patch (SPM 962) at an individual patient's optimal dose for a period of 4 months      Each patient who qualifies and chooses to participate in the study will receive either     rotigotine, pramipexole, or placebo at gradually increasing doses over a period of up to 7     weeks, and then maintain their optimal dose for 4 months.      The study clinic visits will include a medical history and physical exam, ECG, blood and     urine sample collection, completion of various questionnaires, and completion of a diary to     record the severity of their Parkinson's symptoms.      Patients who complete the study may enroll in an extension trial and receive active study     drug.   "
183396|NCT00244400|"     The purpose of the present study was to examine the possible association of hepatic CYP3A     activity and the susceptibility to femur head necrosis in patients treated with     corticosteroids.   "
183397|NCT00244413|"     Nondystrophic myotonias (NDM) are muscle disorders caused by genetic abnormalities in certain     muscle cell membrane proteins. Individuals with NDM experience limited muscle relaxation,     which causes pain, weakness, and impaired physical activity. The purpose of this study is to     better characterize the clinical features and symptoms of NDM.   "
183398|NCT00244426|"     Evaluate efficacy and safety of Indobufen v. Aspirin in preventing thromboembolic events in     patients at high risk of CV events such as patients suffering from nonrheumatic atrial     fibrillation.   "
183399|NCT00244439|"     Current treatments for head lice include over-the-counter products such as permethrin and     prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a     novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice.     The current study will compare the efficacy and safety of this novel formulation of malathion     with OVIDE and with an over-the-counter permethrin product.   "
183400|NCT00244452|"     Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis,     describe dose effect relationship and duration of symptom relief   "
183401|NCT00244465|"     Patients will be followed up for max 18 months. Information on the Adverse Events and     potential misuse or abuse of Xyrem ® will be collected.   "
183402|NCT00244478|"     This is a 16-week intervention to determine the efficacy of an isoflavone-rich soy based meal     supplement to improve bone health and prevent weight and fat gain in 18-19 year old college     females. The primary hypothesis is that participants who receive soy will have favorable     changes in blood markers of bone and less weight and fat gain. The soy is provided by     Physicians Pharmaceuticals, Inc. (Revival Doctor-formulated soy protein).   "
183403|NCT00244491|"     This intervention tests whether encouraging older patients and their caregivers to assert a     more active role in their care transitions could improve clinical outcomes. Patients are     supported by a nurse transition coach and specific tools, including a Personal Health Record.   "
183444|NCT00245024|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of sulindac may prevent breast cancer.      PURPOSE: This randomized phase I trial is studying the effects of sulindac, to prevent breast     cancer, in women at high risk for breast cancer.   "
183404|NCT00244504|"     Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion,     patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day     before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery.     Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up     interviews at 6 and 12 months   "
183405|NCT00244517|"     Anaesthetics may impair the diastolic function of the heart, but the importance of this     finding for patients has not been sufficiently examined. Specially the effects on diastolic     function in patients with diastolic dysfunction has to be determined. The aim of this study     is to examine the effect of isoflurane (only part I), sevoflurane and desflurane (part I+II)     on the diastolic left ventricular function by doppler echocardiography.   "
183406|NCT00244530|"     To compare renal function (51Cr-EDTA clearance) 48 hours post open-heart surgery (coronary     bypass or valve surgery) in patients with impaired renal function after randomization to     either nifedipine infusion at start of surgery and the following 24 hours or placebo (0.9%     saline infusion). Study hypothesis is that nifedipine has a prophylactic effect on decline in     renal function.   "
183407|NCT00244543|"     The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution     compared with placebo in alleviating the signs and symptoms of conjunctival allergen     challenge-induced allergic conjunctivitis   "
183408|NCT00244556|"     To investigate the changes in MRI-derived markers of joint inflammation and destruction and     in biochemical markers of connective tissue metabolism and angiogenesis in rheumatoid     arthritis patients treated with Enbrel and Enbrel+methotrexate.   "
183409|NCT00244569|"     The purpose of this study is to determine the safety and efficacy of the Oridion Breath ID     machine in monitoring liver metabolic functions.   "
183410|NCT00244582|"     This study will use an experimental method of delivering the enzyme glucocerebrosidase     directly into the brain of a patient with Gaucher disease to treat disease symptoms. Patients     with Gaucher disease have insufficient levels of glucocerebrosidase. As a result, substances     normally broken down by this enzyme accumulate in the body, causing damage to the brain and     other organs. Symptoms of Gaucher disease outside the brain can be treated by infusing the     missing enzyme intravenously (IV, through a vein). However, IV infusions do not help the     neurologic symptoms of the disease, because the enzyme cannot get into the brain. This study     will use a new technique called convection-enhanced delivery to try to introduce     glucocerebrosidase directly into the brain.      This single-patient study includes an 8-month-old male with Type 2 Gaucher disease with     progressive neurological decline.      In preparation for the enzyme infusion, the patient will have a complete physical     examination, including a detailed neurological examination, and blood and urine tests. On the     day of surgery, the child will be placed under general anesthesia for magnetic resonance     imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to produce images of     body tissues and organs. For this procedure, the child lies on a table that is moved into the     scanner (a narrow cylinder), wearing earplugs to protect his hearing from the loud knocking     and thumping sounds that occur during the scanning process. He will then be brought to the     operating room for the infusion procedure, as follows:      An incision will be made in the scalp and a small hole drilled through the skull. Then, a     small tube (cannula) will be positioned through the hole into the target area in the brain.     Once the tip of the cannula is in place, it will be connected with tubing to a syringe filled     with glucocerebrosidase in saline (salt water). The child will then have a second MRI scan to     make sure the cannula is placed correctly and to monitor delivery of the glucocerebrosidase     to the brain. The child will be monitored closely with MRI scans every 30 to 60 minutes     during the infusion to look for fluid in the brain and determine the extent of the enzyme     perfusion. The infusion will last no longer than 6 hours and will be stopped when the full     dose of enzyme has been delivered. The cannula will be removed and the scalp incision closed.     The child will stay in the hospital for observation from 4 to 10 days, with at least 24 hours     in the intensive care unit and 3 to 7 days in the pediatric unit.      The child will be seen in the clinic two weeks after discharge and then once a month for 3     months to evaluate any possible effects of the surgery. These follow-up visits include a     repeat MRI scan and neurological examination. After the first 3 months, visits may be less     frequent.      If the child continues to have symptoms during the course of follow-up or his neurologic     status worsens, additional enzyme infusions will be offered, possibly including treatment of     the brainstem. If the child gains no benefit after three infusions have been performed, no     additional infusions will be offered. If there appears to be any neurological benefit,     additional infusions may be offered.   "
183411|NCT00244595|"     The objectives of this study are to describe candesartan cilexetil antihypertensive effects     in terms of achieved blood pressure and hypertension control rates and the relationship     between subject characteristics and antihypertensive efficacy, and between antihypertensive     therapy (candesartan cilexetil dose and add-on treatments) and efficacy over a 1 year     treatment period in hypertensive children ages 6 to < 17 years; to describe growth in terms     of height and weight in the study population; to describe change in neurocognition as     assessed by the Full Scaled IQ score in a subset of study subjects; to determine the     pharmacokinetics of candesartan in hypertensive paediatric subjects ages 6 to < 17 years; and     to describe safety including adverse events and adverse events necessitating study drug     discontinuation including dose level and dose duration relationships and growth over a 1 year     period in hypertensive children age 6 to < 17 years.   "
183412|NCT00244608|"     The purpose of this study is to determine if a flexible dose of Symbicort has a similar     effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with     additional glucocorticosteroids added.   "
183413|NCT00244621|"     This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages     1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design     intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo     run-in, a 4-week double blind treatment, and a 52-week open-label, long-term treatment     period. Subjects undergo a screening evaluation, then a 1-week single-blind, placebo run-in,     after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan     cilexetil (0.05 mg/kg, or 0.20 mg /kg or 0.40 mg /kg), liquid formulation, in a 1:1:1 ratio     for 4-weeks. At the end of randomized dose allocation (Day 28), blood pressure assessment     will be performed and subjects may begin the 52-week, open-label treatment period of the     study.   "
183414|NCT00244634|"     Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a     multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group     study with a 4 week treatment period in hypertensive pediatric subjects.      Subjects undergo a screening evaluation, then a 1-week, single-blind, placebo run-in after     which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil     or placebo. The study includes 2 panels based on subject weight.      The primary efficacy analysis is based on the intent-to-treat population and tests for slope     = 0 in a linear regression model with change in sitting systolic blood pressure as the     dependent and non-zero dose pooled across weight panels as the independent variable. For     subjects without a Double-Blind Week 4 blood pressure determination, carrying the last value     forward assigns the value.      Additional analyses will include data pooled from a similar dose ranging study conducted in     children 1 to < 6 years of age.   "
183415|NCT00244647|"     The process of re-narrowing of a coronary artery following a revascularization procedure such     as angioplasty, begins at the time of the procedure. Restenosis has long been considered a     major problem for effective long-term interventional success. This often results in repeated     procedures to deal with recurrent stenosis (or restenosis) of the original targeted vessel.      There is a substantial body of literature suggesting that local MYC protein production in the     injured coronary artery is a major stimulus and potential cause of restenosis that appears     after stent placement. This study is based upon the hypothesis that stopping MYC protein     production in the vessel has will help reduce restenosis (vessel re-narrowing).      AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that     interferes with MYC production.      This study will evaluate the safety, pharmacokinetics and potential effectiveness of a single     intravenous slow-push dose of RESTEN-MP at the time of stent placement to reduce in-stent     restenosis following balloon angioplasty and stent placement. The post-dose follow-up period     is up to six-months.   "
183416|NCT00244660|"     To investigate the effect on blood pressure (BP) control in hypertensive patients using a     combination of frequent home - and 24-h ambulatory blood pressure measurement (ABPM) in a     Danish general practice (GP) setting.   "
183417|NCT00244673|"     In non-randomized studies, routine childhood vaccinations have been observed to have     non-targeted effects. Difteria-tetanus-pertussis (DTP) vaccine provided with or after measles     vaccine (MV) is associated with increased mortality in areas with herd immunity to pertussis.      We will examine in a randomised study of 6000 children the effect of not administering DTP     simultaneously with or after MV on overall child mortality, hospitalization rates, and the     immunological responses after vaccination. We will also examine potential sex-differential     effects in the outcomes and interactions with other vaccines, other health interventions and     season.   "
183418|NCT00244686|"     104317: The market authorisation application for mepolizumab for the indication of     hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to     outstanding questions from regulator's raised from the application. On the basis of sponsor's     evaluation, participants with life-threatening HES who have documented failure (lack of     efficacy or a contra-indication) to at least 3 standard HES therapies (compassionate use) and     participants who have participated in a previous GSK sponsored study in HES (long-term     access) can be consider for mepolizumab treatment where the country regulation permits. In     this study, participants will receive mepolizumab in an open-labelled manner, and limited     data will be collected to evaluate the long-term safety and efficacy of mepolizumab.      201956: This is a Long-term Access Programme (LAP) which aims to support provision of     mepolizumab, until it is commercially available, to eligible subjects with severe asthma who     participated in a GSK-sponsored mepolizumab clinical study in severe asthma. Eligible     subjects will initiate mepolizumab within a 6-month period following the individual subject's     last scheduled visit in their preceding clinical study. For each subject benefit versus risk     will be assessed throughout the study to support continued treatment with mepolizumab.   "
183419|NCT00244699|"     The proposed study will evaluate the clinical effectiveness of integrating mindfulness-based     skills training into a standardized brief group intervention for youth (ages 16 to 24)     identified as having problematic substance use. Forty youth (N = 20 per group) will be     randomized to one of two treatment conditions: 1) a standardized 4-week brief treatment for     problematic substance use (treatment as usual; TAU) or 2) standardized brief treatment (TAU)     augmented with a mindfulness skills training component based primarily on the mindfulness     module described in Linehan's (1993b) Dialectical Behavior Therapy skills group training. It     is expected that, compared to the TAU, the mindfulness-based group plus TAU will produce     superior outcomes on the following primary outcome measures: number of substance use days,     confidence to resist urges to use substances, and mindfulness skills. Secondary outcomes that     will be examined include severity of consequences of use, general psychiatric symptoms,     self-compassion, emotion dysregulation, and transfer to further treatment.   "
183420|NCT00244712|"     This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine)     and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used     in combination with KALETRA (lopinavir/ritonavir) over 96 weeks   "
183421|NCT00244725|"     Odiparcil is being studied to determine if it can prevent blood clots from forming after a     total knee replacement and also to prove that odiparcil is safe.   "
183422|NCT00244738|"     The purpose of the study is to determine whether castor oil is effective in inducing labor.   "
183466|NCT00245310|"     Indocyangreen (ICG)is totally biliary eliminated and corresponds to hepatocyte function and     liver perfusion.      The ICG-clearance will be evaluated as a prognostic marker in liver disease.   "
183423|NCT00244751|"     The purpose of this study is to examine the safety and effectiveness of GI262570 compared to     placebo (a pill that looks exactly like GI262570 but contains no active medicine) in     improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who     are enrolled in the study must have had prior treatment with interferon (either pegylated or     standard interferon) plus ribavirin for at least 12 weeks to treat their hepatitis C, but     either failed to clear the virus or didn't tolerate the treatment.   "
183424|NCT00244764|"     Phase II, multi-center, two-stage study utilising a randomised discontinuation design to     evaluate the safety and efficacy of GW786034 (pazopanib) in adult subjects with locally     recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC). After the interim analysis,     the design was changed to an open label, single arm study with all subjects receiving     pazopanib.   "
183425|NCT00244777|"     The World Health Organization has very recently recommended the routine use of a hypo-osmolar     ORS in the management of diarrhoeal diseases. This recommendation is based on the better     efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled     clinical trials. The recommendation, however, also expressed the need for careful monitoring     to better assess risk, if any, of symptomatic hyponatraemia. There thus is a need for phase     IV trials before the new solution is introduced into routine clinical practice to assess the     risk in relatively large number of patient populations. The proposed study will be carried     out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients)     and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The     hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients     with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L.     Surveillance will be carried out to detect adverse events focusing on the occurrence of     seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy     would be evaluated to determine if they are associated with abnormal levels of serum sodium     or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially     admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab     Hospital might require admission to the longer stay inpatient wards due to seizure or altered     consciousness. Such patients would be thoroughly assessed including determination of their     serum sodium and glucose, two common causes of seizures/altered consciousness, to determine     if and to what extent they could be attributed to hyponatraemia.The results from this study     would be used in planning and implementing the routine use of the new formulation of ORS at     all Government, NGO and private health care facilities that treat diarrhoeal patients, in     Bangladesh and in other countries.   "
183426|NCT00244790|"     The purpose of this study is to determine if being overweight and eating lots of protein     causes separate changes in the kidney that lead to kidney disease over time. These questions     are important because the number of people who have kidney disease is quickly growing. If     being overweight and eating lots of protein is found to cause kidney disease, then doctors     may be able to limit the number of people with kidney disease by recommending weight loss and     eating less protein   "
183427|NCT00244803|"     The purpose of this study is to learn whether HIV-infected patients have blood abnormalities     which could lead to heart attack or stroke, and to find out what factors may contribute to     these abnormalities.   "
183428|NCT00244816|"     To evaluate objective response rate and duration of response to weekly Taxoprexin®.      To evaluate the safety profile of weekly Taxoprexin® in this patient population.      To evaluate overall survival in the same patient population. To evaluate time to disease     progression, and the time to treatment failure in patients with metastatic choroidal melanoma     being treated with weekly Taxoprexin® Injection.   "
183429|NCT00244829|"     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Giving imatinib mesylate after a donor stem cell transplant     may prevent the recurrence of Philadelphia chromosome-positive leukemia.      PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate after     a donor stem cell transplant and to see how well it works in treating patients with     Philadelphia chromosome-positive leukemia.   "
183430|NCT00244842|"     The purpose of this study is to determine which dose of voclosporin is effective in the     treatment of plaque psoriasis compared to placebo.   "
183431|NCT00244855|"     This phase II trial studies the side effects and how well giving rituximab and dexamethasone     together works in treating patients with low-grade non-Hodgkin lymphoma (NHL). Monoclonal     antibodies, such as rituximab, can block cancer growth in different ways. Some block the     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or     carry cancer-killing substances to them. Drugs used in chemotherapy, such as dexamethasone,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving rituximab together with dexamethasone may kill more     cancer cells   "
183432|NCT00244868|"     RATIONALE: A computer-based survey and communication aid may help physicians and patients to     communicate better and help make treatment decisions easier.      PURPOSE: This phase III randomized clinical trial is studying how well giving a     computer-based survey together with a communication aid works compared to a computer-based     survey alone in improving physician-patient communication and treatment decision making in     patients with metastatic cancer.   "
183433|NCT00244881|"     AZD2171 (cediranib maleate) may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial     is studying how well AZD2171 works in treating patients with refractory stage IV breast     cancer   "
183434|NCT00244894|"     RATIONALE: Acupuncture may help relieve hot flashes in patients with prostate cancer.      PURPOSE: This clinical trial is studying how well acupuncture works in treating hot flashes     in patients with prostate cancer who are undergoing androgen deprivation.   "
183435|NCT00244907|"     Estrogen is a hormone that helps prevent calcium loss and bone breakdown. During menopause,     estrogen levels decrease. Insufficient amounts of estrogen may lead to bone loss and possibly     osteoporosis. Isoflavones are natural compounds found in soy plants that may help provide     protection against bone loss. This study will evaluate the effect of soy isoflavones on     calcium absorption and bone loss in post menopausal women.   "
183436|NCT00244920|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide     and bicalutamide, may stop the adrenal glands from making androgens. Squalamine lactate may     stop the growth of prostate cancer by blocking blood flow to the tumor. Giving hormone     therapy together with squalamine lactate before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed.      PURPOSE: This randomized phase II trial is studying how well giving hormone therapy together     with squalamine lactate works compared to hormone therapy alone in treating patients who are     undergoing a radical prostatectomy for locally advanced prostate cancer.   "
183437|NCT00244933|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine hydrochloride together     with genistein works in treating women with stage IV breast cancer.   "
183438|NCT00244946|"     RATIONALE: Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and     melphalan work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more cancer cells. A peripheral stem cell transplant may be able to replace     blood-forming cells that were destroyed by chemotherapy. Giving white blood cells, that have     been treated in the laboratory with antibodies, may make the transplant work better. Giving     combination chemotherapy followed by an autologous stem cell transplant, and white blood cell     infusions may be an effective treatment for non-Hodgkin's lymphoma.      PURPOSE: This phase I trial is studying the side effects and best dose of white blood cell     infusions when given together with combination chemotherapy, and autologous stem cell     transplant in treating patients with non-Hodgkin's lymphoma that has relapsed, is refractory,     or is in remission.   "
183439|NCT00244959|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.      PURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who     have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast     cancer.   "
183440|NCT00244972|"     This phase I trial studies the side effects and best dose of tipifarnib when given together     with sorafenib tosylate in treating patients with biopsiable cancer that has spread to other     places in the body and usually cannot be cured or controlled with treatment. Tipifarnib and     sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the cancer.   "
183441|NCT00244985|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as liposomal doxorubicin, work in different ways to stop the growth of cancer cells, either     by killing the cells or by stopping them from dividing. Giving rituximab together with     liposomal doxorubicin may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with     liposomal doxorubicin and to see how well they work in treating patients with relapsed or     refractory B-cell non-Hodgkin's lymphoma.   "
183442|NCT00244998|"     RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using     fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells.      PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with     advanced prostate cancer.   "
183443|NCT00245011|"     RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry     radiation directly to tumor cells and not harm normal cells. A peripheral stem cell     transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and     samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill     tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem     cell transplant and radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam     pentasodium together with autologous stem cell transplant and radiation therapy works in     treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.   "
183445|NCT00245037|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor     peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune system and help destroy any remaining cancer cells     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte     infusion) after the transplant may help increase this effect. Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.      PURPOSE: This phase I/II trial is studying the side effects of giving busulfan and     fludarabine together with total-body irradiation and to see how well they work in treating     patients who are undergoing a donor stem cell transplant for hematologic cancer.   "
183446|NCT00245050|"     RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by     chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in     preventing hand-foot syndrome.      PURPOSE: This randomized clinical trial is studying pyridoxine to see how well it works     compared to a placebo in preventing hand-foot syndrome in patients who are receiving     liposomal doxorubicin for recurrent ovarian, fallopian tube, or peritoneal cancer, metastatic     breast cancer, or advanced endometrial cancer.   "
183447|NCT00245063|"     This phase II trial is studying how well AZD2171 works in treating patients with recurrent     small cell lung cancer. AZD2171 may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.   "
183448|NCT00245076|"     RATIONALE: Stop-smoking information on the smokefree.gov website may help people quit smoking     and remain a nonsmoker.      PURPOSE: This clinical trial is studying how well the smokefree.gov website works with an     electronic bulletin board in helping United States federal employees quit smoking.   "
183449|NCT00245089|"     RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving more than one drug (combination     chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and     cyclophosphamide together works in treating patients with embryonal rhabdomyosarcoma.   "
183450|NCT00245102|"     This phase II trial is studying how well sorafenib works in treating patients with     metastatic, locally advanced, or recurrent sarcoma. Sorafenib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to     the tumor.   "
183451|NCT00245115|"     RATIONALE: Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs,     helps stem cells move from the bone marrow to the blood so they can be collected. Treating     stem cells collected from the patient's blood or bone marrow with chemotherapy in the     laboratory removes any remaining cancer cells. Chemotherapy or radiation therapy is given to     the patient to prepare the bone marrow for stem cell transplant. The treated stem cells are     then returned to the patient to replace the blood-forming cells that were destroyed by the     chemotherapy.      PURPOSE: This clinical trial is studying how well an autologous peripheral stem cell or bone     marrow transplant using laboratory-treated cells works in treating patients with acute     leukemia.   "
183452|NCT00245128|"     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and how well     it works in treating patients with myelofibrosis.   "
183453|NCT00245141|"     RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to     kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and     cyclophosphamide together with or without radiation therapy works in treating patients with     embryonal rhabdomyosarcoma.   "
183454|NCT00245154|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Cediranib maleate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel and     carboplatin together with AZD2171 may kill more tumor cells. It is not yet known whether     giving paclitaxel and carboplatin together with AZD2171 is more effective than giving     paclitaxel and carboplatin together with a placebo in treating non-small cell lung cancer.      PURPOSE: This randomized phase II/III trial is studying how well giving paclitaxel and     carboplatin together with cediranib maleate works and compares it to giving paclitaxel and     carboplatin together with placebo in treating patients with stage III or stage IV non-small     cell lung cancer.   "
183455|NCT00245167|"     The first objective of this study is to determine if increased expression of one or more     members of the toll-like receptor (TLR) family of receptors that are found on inflammatory     cells (present in the airway) precede development of chronic lung disease (CLD) of     prematurity. The study will also determine if there is a significant correlation between TLRs     and the severity of CLD. The second objective of this study is to determine the impact of     c-administration of inhaled nitric oxide (INO) on TLR expression in infants at risk of     developing CLD or with early CLD.   "
183456|NCT00245180|"     The purpose of this study is to establish an intervention to keep American Indian/Alaskan     Native (AI/AN) children from becoming overweight.   "
183457|NCT00245193|"     This study will investigate the effectiveness of motivationally-enhanced brief interpersonal     psychotherapy (MI-IPT-B) in treating depression in mothers who bring their children to a     child mental health clinic for psychiatric treatment.   "
183458|NCT00245206|"     This study will compare four atypical antipsychotic medications in terms of the risk of     specific side effects each of them presents in middle-aged and elderly individuals.   "
183514|NCT00245934|"     The purpose of this study is to investigate the incidence of adverse events for patients with     rheumatoid arthritis treated with Enbrel under usual care settings. In addition, differences     in injection site reactions based on whether health care professionals or patients administer     Enbrel will be assessed and evaluated.   "
183459|NCT00245219|"     The present study sought to investigate the efficacy of two psychosocial interventions for     breast cancer patients, a peer support intervention and an education intervention. The     present study also sought to identify mechanisms underlying the benefits of these     interventions, and to determine if the efficacy of these interventions is moderated by cancer     severity.   "
183460|NCT00245232|"     This study will evaluate the effectiveness of cognitive processing therapy versus its     individual components in treating women with post-traumatic stress disorder (PTSD) and     depression brought on by sexual assault.   "
183461|NCT00245245|"     The ability of a new recombinant porcine coagulation factor VIII, B-domain deleted (called     OBI-1), to control the non-life- or limb-threatening bleeding episodes patients with     hemophilia A commonly develop is being evaluated. Patients with congenital hemophilia A and a     low-titer (<20 Bethesda units [Bu]) inhibitory antibody to OBI-1, who meet the     inclusion/exclusion criteria, will receive OBI-1 to treat their soft tissue or joint bleeding     episode. At least the first two treatment episodes will be performed in the controlled     setting of the hemophilia center/clinic/office, where any side effects can be observed. If     the patient continues to meet the inclusion/exclusion criteria, has had no serious or severe     adverse reactions to OBI-1, and has been in a home care program, the investigator may permit     the patient to self-administer OBI-1 at home to treat subsequent bleeding episodes. The study     will continue at least until 12 or more patients have received at least 24 treatment episodes     in the aggregate.   "
183462|NCT00245258|"     The study objective is to:        1. To evaluate the effect of sildenafil citrate versus placebo on the IIEF_EF Domain at the          end of the double-blind phase        2. To assess the relationship between treatment with sildenafil citrate or placebo and          responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience          Questionnaire (SEX_Q).   "
183463|NCT00245271|"     OMS103HP is being developed for improvement in knee function following ACL reconstruction.     Secondary benefits being evaluated include reduced postoperative pain, improvement in knee     motion and earlier return to work.   "
183464|NCT00245284|"     Evaluation of skin cholesterol for cardiovascular risk assessment in asymptomatic individuals     at low, intermediate, or high risk based on Framingham Global Risk estimates. Carotid     intima-media thickness (IMT), a surrogate marker for atherosclerotic burden, that     independently predicts the occurrence of heart attack and stroke, will be the “gold standard”     comparator.      Hypothesis: Skin cholesterol, as measured by two non-invasive tests, correlates with CAD, as     measured by CIMT in this population.   "
183469|NCT00245349|"     Preliminary observations suggest positron emission tomography (PET) imaging with an F-18     labeled thymidine analog (FLT) can selectively identify proliferating and non-proliferating     tissues, including tumors. FLT uptake in the tumor appears to reflect the level of cells     undergoing DNA synthesis. This is clinically important because cell proliferation markers     have significant prognostic value, both prior to initiating radiotherapy and as they change     during the course of therapy. In the proposed study, the researchers assess the     biodistribution and radiation dosimetry of FLT to obtain the necessary data to file an     Investigational New Drug (IND) application with the Food and Drug Administration (FDA). The     information collected under Radioactive Drug Research Committee (RDRC) approval will not be     used for diagnostic purposes, to assess the subject's response to therapy, or for clinical     management of the subject.   "
183470|NCT00245362|"     To evaluate the safety and effectiveness of CG8020 and CG2505.   "
183471|NCT00245375|"     Increasingly in general surgery, the investigators are conducting outpatient day surgery.     Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America.     These patients all require some form of analgesia which can be taken at home in the first few     days after the surgery. The current standard at the investigators' centre and many others in     the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or     oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as     oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication     (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects,     and may not provide effective pain relief. In the investigators' experience, non-steroidal     anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic     regimen.      Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain     medication. They hope to show that a combination of ibuprofen and acetaminophen is better for     pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a     safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of     surgeons are old habits, it will require a very convincing argument to get them to change     their practices. A randomized controlled trial comparing these two regimens, the     investigators hope, would be a powerful enough argument.      The hypothesis of this study, therefore, is that the pain control provided by a combination     of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to     Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day).      This study will attempt to enroll 150 patients in total. Eligible patients will be identified     by their attending surgeon and contacted by study personnel. Patients who enroll in the study     will undergo their surgery in the usual manner. After the surgery, in the recovery room, once     they are ready to go home, they will be randomized to receive combination A or B and be given     a week's worth of pain medication. They will then go home and take this medication as     directed. They will record their pain intensity and pain relief once per day using a diary     provided in the study package. One week after their surgery, they will return to the hospital     clinic and be seen by the study nurse. They will hand over the diary and any unused     medication. They will also be asked several questions regarding their overall satisfaction,     incidence of side effects, and how long until they were pain free.      The risks of participating in this study are minimal from the risks inherent to the     procedures and medications the patients would receive within the standard of care. Ibuprofen     is a commonly used NSAID which is widely available over the counter and has an established     safety profile. The most common adverse effects of ibuprofen and other NSAIDs are     gastrointestinal bleeding and ulceration. Other less common adverse effects include     nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive     dysfunction. The investigators' patients will be selected to exclude those most at risk for     these complications (see exclusion criteria). Acetaminophen has few side effects, with no     adverse effects on platelet function and no evidence of gastric irritation.   "
183472|NCT00245388|"     This is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the     lipid-lowering efficacy and safety of BMS-298585 (muraglitazar) alone in combination with     pravastatin in subjects with mixed dyslipidemia.   "
183473|NCT00245401|"     The purpose of this PMS registry, named e-CYPHER Stent Registry, is to collect post marketing     surveillance data on the CYPHERTM Sirolimus-eluting Coronary Stent following marketing     approval, when used in normal clinical practice within the labeled indications.   "
183474|NCT00245414|"     The purpose of this study is to investigate the efficacy and safety of Pegasys® 180μg for     subcutaneous (s.c.) injection in interferon (IFN)-treated or IFN-untreated chronic hepatitis     C patients except for those infected with genotype 1b of hepatitis C virus (HCV) and a high     viral load (≥ 100 KIU/mL).      In addition, this study will explore the efficacy and safety of Pegasys® 180μg for s.c.     injection given at 2 different periods between 24 and 48 weeks in IFN-untreated chronic     hepatitis C patients.   "
183475|NCT00245427|"     A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide     antibiotics in the community   "
183476|NCT00245440|"     The purpose of this study is to measure the speed of microbial eradication due to     azithromycin or telithromycin in acute maxillary sinusitis (AMS).   "
183477|NCT00245453|"     To measure the speed of bacterial eradication from the respiratory tract after administration     of azithromycin or telithromycin.   "
183478|NCT00245466|"     To investigate the long-term safety and tolerability of repeated doses of degarelix to     prostate cancer patients   "
183515|NCT00245947|"     Evaluate the response of inflammatory serum markers to oral ERB-041 in subjects with     inflammation associated with active Crohn's disease.   "
183516|NCT00245960|"     To assess the efficacy of two different treatment regimens of etanercept in psoriasis     subjects with psoriatic arthritis with respect to both the skin and joint manifestations.   "
183479|NCT00245479|"     To evaluate the overall response to desmopressin treatment among previously untreated     enuretic children aged 5-15 years after 3 and 6 months of treatment.      To investigate the influence of possible predictive factors on response after 3 and 6 months     of treatment.      To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety     profile of oral desmopressin in children with primary nocturnal enuresis.   "
183480|NCT00245492|"     The proposed research aims to determine the prevalence, size, shape and histology of flat     colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for     screening colonoscopy. Patients will be randomized to either conventional colonoscopy or     chromocolonoscopy, where the entire colon will be sprayed with indigocarmine dye and examined     in the usual manner. The primary outcome will be the total number of adenomas detected, with     special attention to the subgroup of flat and depressed lesions. To promote the     generalizability of the results, neoplasms will be described according to standard Western     and Japanese classification schemes.   "
183481|NCT00245505|"     The purpose of this study is to visualize the healing effect on mucosal lesions with Pentasa     Sachet 4g in patients with mild to moderate active small bowel CD by video capsule endoscopy.   "
183482|NCT00245518|"     This study will look at the effects of a soy supplement called Revival on memory, quality of     life, and hot flashes in men with prostate cancer who are being treated with testosterone     suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will     result in at least a 50% reduction in hot flashes compared to placebo.   "
183483|NCT00245531|"     The purpose of this study is to understand the effects of decreased functioning of the testes     or ovaries on mental performance in males and females using illicit drugs excluding     marijuana.   "
183484|NCT00245544|"     The purpose of this study is to test the safety and effect of MK0759 in relieving neuropathic     pain as experienced by patients with postherpetic neuralgia (PHN).   "
183485|NCT00245557|"     The purpose of this study was to use Magnetic Resonance Images to further our understanding     of predictors and markers of treatment response and non-response in geriatric depression. We     hypothesized that concentrations of high energy metabolites would be lower in depressed     elderly compared to non-depressed.   "
183486|NCT00245570|"     To determine the effect of an approved medication being studied in support of a new approach     in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also     known as exercise-induced bronchospasm), in patients who have a history of worsening asthma     after exercise.   "
183487|NCT00245583|"     This study will assess the efficacy of topiramate in the treatment of pathological gambling.     Pathological gambling (PG) is a debilitating disorder, generally leading to severe personal,     familial, financial, social, and occupational impairments. In PG, the patient experiences a     progressive inability to resist impulses to gamble, and gambling significantly disrupt the     patient's functioning in the personal, familial, and/or vocational spheres. Topiramate has     shown preliminary evidence of efficacy in some impulse control disorders.   "
183488|NCT00245596|"     The purpose of the study is to assess the sensibility of the ISL questionnaire.   "
183489|NCT00245609|"     The primary purpose of the trial is to assess how effective pregabalin, alprazolam, and     placebo are at reducing anxiety levels of subjects who take a dose of these treatments 4     hours before a scheduled dental procedure.   "
183490|NCT00245622|"     This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell     therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple     sclerosis (RR-MS).   "
183491|NCT00245635|"     This trial will study the effectiveness of the medication fluoxetine for children and     adolescents ages 16 and younger with BDD who qualify.   "
183492|NCT00245648|"     This study evaluated differences between men and women in the presentation, management and     outcome of heart attacks within the GUSTO V study.   "
183493|NCT00245661|"     The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime     on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary     disease.      The study hypothesis is that temazepam does not produce any adverse respiratory effects     during sleep in patients with COPD. In contrast, it may result in an beneficiary effect     because it positively affects the sleep quality and sleep structure which may result in more     alertness and less daytime sleepiness and less dyspnea during the day.   "
183494|NCT00245674|"     During this study the efficacy and safety profile will be evaluated of the use of amisulpride     in the form of a solution in schizophrenic patients with an acute episode.      The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a     solution during the first days of an acute episode of schizophrenia.   "
183495|NCT00245687|"     The purpose of this study is to compare the success rates of two types of feeding tubes,     specifically the standard gastric feeding tube to a small bowel feeding tube.   "
183496|NCT00245700|"     To test if combining two antiparkinson drugs into a single tablet improves accuracy of     medicine intake by the patient.      To test if patients with Parkinson's disease who take medicines at regular time intervals     have smoother symptom control.   "
183497|NCT00245713|"     Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy     receiving a classical antiepileptic drug   "
183511|NCT00245895|"     The purpose of this study is to see if darbepoetin alfa is an effective treatment for anemia     in prostate cancer patients and, if so, what dose is most effective. Sometimes prostate     cancer patients have low red blood cell counts (low hemoglobin) from various treatments they     are receiving, such as chemotherapy. The red blood cells deliver oxygen to the tissue. This     then helps give the patient more energy.   "
183512|NCT00245908|"     The ASTHMA Pilot Study is a randomized, controlled, parallel group clinical trial of 6 weekly     doses of azithromycin (cumulative dose 4800 mg) or placebo as adjunctive treatment in     addition to usual care for adults with stable persistent asthma, with final follow up at 3     months after completion of study medication.      The hypothesis to be tested is that antibiotic treatment will improve asthma at followup, and     that this improvement will be limited to patients with evidence of C. pneumoniae infection.      The secondary hypothesis is that randomized, controlled treatment trials can be carried out     successfully in a geographically dispersed practice-based research network.   "
183498|NCT00245726|"     The overall objective of this research project is to examine the clinical efficacy of lower     extremity cycling with functional electrical stimulation to improve the health and fitness of     children with spinal cord injuries (SCI). To achieve this goal, a controlled, randomized     study will be conducted with thirty children who have sustained a spinal cord injury. The     children in the study will be assigned to one of three groups: those receiving functional     electrical stimulation (FES) leg cycling exercise, those receiving passive leg cycling, and a     non-cycling control group receiving electrical stimulation therapy to generate muscle     contractions in the lower extremity. All three groups will be balanced as to the amount of     time they receive the specific therapy. All therapies, after initial assessment, will be     conducted at home in order to foster changes in lifestyle that may prove to be essential for     improved quality of life.      The specific aims of this proposal are delineated below:      Aim 1: To assess, by means of a randomized controlled study design, the ability of FES     cycling to improve the cardiovascular and musculoskeletal systems of ten children with a     spinal cord injury, as compared to ten children undergoing passive leg cycling exercise and     ten children receiving electrical stimulation therapy alone.      Aim 2: To determine, by means of a randomized controlled study design, the feasibility of     using FES leg cycling exercise to provide long-term health benefits and improve the     neurologic status of ten children with a spinal cord injury, as compared to ten children     undergoing passive leg cycling exercise and ten children receiving electrical stimulation     therapy alone.   "
183499|NCT00245739|"     The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for     HIV-1 infected patients with limited or no treatment options, who have failed multiple     antiretroviral (ARV) regimens, and to evaluate the longer-term safety and tolerability of     TMC114/r in combination with other antiretrovirals   "
183500|NCT00245752|"     The purpose of the study is to evaluate whether acupuncture can be used to ripen cervix     before medicinal induction of labor or even be used as method for induction, and thereby     eliminating other and more potentially harmful methods.   "
183501|NCT00245765|"     A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo,     administered during 12 weeks, to patients suffering from moderate to severe chronic plaque     psoriasis, extended by a 12 to 24 week follow-up.   "
183502|NCT00245778|"     The aim of the study is to localise brain regions involved in objects recognition, in     planification and adjustment of grasping, in prehension with and without eye control. The     study is conducted in normal and autistic adults. We hypothesize different activations in     these two populations.   "
183503|NCT00245791|"     The purpose of the study is to compare the safety and effectiveness of the antibiotic     levofloxacin by administering a higher dose of levofloxacin and using a shorter course of     therapy.   "
183504|NCT00245804|"     Developmental dyslexia is a frequent learning disability. The aim of this study is to compare     auditory evoked cortical responses to syllables and tones in developmental dyslexia and     controls (paired with age, gender). The study is conducted in 3 groups of subjects :8-10     years ; 11-17 years and 18-25 years. We suppose that cortical responses should be different     in developmental dyslexia and controls.   "
183577|NCT00239330|"     The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with     atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target     goals after 12 weeks of therapy.   "
183505|NCT00245817|"     HINCAB-study is a single senter, prospective, randomised controlled trial. The aim of the     study is to test the effect of a home based intervention program. The hypothesis of the study     is that a home based intervention will influencing coping strategies in the CABG-patients     rehabilitation phase, reduce symptoms and improve health related quality of life.   "
183506|NCT00245830|"     The long-term goals of this proposal are to develop clinical protocols of donor     preconditioning to improve liver graft function and ameliorate complications of poor graft     function after liver transplantation. Achievement of these objectives would improve liver     recipient outcomes, increase utilization of livers and alleviate the current critical     shortage of livers for transplantation. More stringent liver donor selection intended to     decrease the complications of poor graft function conflicts directly with efforts to maximize     the use of donor livers. Ischemic preconditioning (IPC) of liver attenuates hepatic ischemia     reperfusion injury (IRI) in animals. Preliminary data show hepatic IPC effectively decreases     IRI following hepatic resection in humans.      The specific aims of this project are: AIM 1: To test the hypothesis that 10 minutes of     hepatic ischemic preconditioning in deceased donors would improve liver graft function and     decrease injury in the early post transplant period. AIM 2: To test the hypothesis that     ischemic preconditioning of deceased donor livers would decrease systemic inflammatory     response in liver recipients in the early post transplant period. AIM 3: To examine whether     ischemic preconditioning of deceased donor livers decreases early post transplant pulmonary     edema and acute rejection and shortens hospital stay.   "
183507|NCT00245843|"     The purpose of this study is to investigate if the effects of the Vermont intervention,     implemented by nurses in a Neonatal Intensive Care Unit (NICU), can influence social     interaction and joint attention skills between parents and preterm babies in the second half     of the first year of life.   "
183508|NCT00245856|"     The purpose of this study is to document the long-term outcome or prognosis of patients     diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin     sodium injection) for three months.   "
183509|NCT00245869|"     This study intends to assess the ability of contrast-enhanced ultrasound to make the efficacy     of chemotherapy in breast cancer precise.      This real-time noninvasive and feasible imaging technique allows us, the investigators at     University Hospital Tours, to evaluate early vascular changes of breast tumors during     treatment. These vascular changes may precede long-term tumoral regression. Imaging of     primary breast lesions may be of value in the prediction of late treatment response.      An ultrasound will be performed before the initiation, and after the second and the last dose     of chemotherapy.      To investigate the changes occurring in the vascularization of tumors, we will use an     intravascular ultrasound contrast agent SonoVue (sulphur hexafluoride microbubbles).      This agent is a microbubbles preparation that is stable, resistant to pressure, and     specifically designed to be used as a contrast agent for ultrasound imaging of angiogenesis.   "
183510|NCT00245882|"     The purpose of this research study is to compare two different methods of helping veterans     with diabetes better manage their disease. This study will compare an Active Care     Management method using home-based technology and self-monitoring techniques with a     lower-intensity Care Coordination method based on monthly telephone contact with a nurse.   "
183520|NCT00246025|"     The goal of this study is to evaluate the comparative efficacy and safety of three different     doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to     placebo, in prevention of venous thromboembolism in patient with primary elective total knee     replacement surgery, and to evaluate dose-response.   "
183521|NCT00246038|"     A prospective, actively controlled, consecutively enrolling, non-randomized multi center     clinical evaluation of the safety and efficacy of the Boston Scientific ENOVUS AAA Endograft     when used in the treatment of patients with AAA (Treatment Group) as compared to patients     treated with conventional open surgery (Control Group).   "
183522|NCT00246051|"     Police officers work some of the most demanding schedules known, which increases their risk     of sleep deprivation and sleep disorders. The need to work frequent overnight shifts and long     work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of     circadian phase. The public expects officers to perform flawlessly, but sleep deprivation and     unrecognized sleep disorders significantly degrade cognition, alertness, reaction time and     performance. In addition, both acute and chronic sleep deprivation adversely affect personal     health, increasing the risk of gastrointestinal and heart disease, impairing glucose     metabolism, and substantially increasing the risk of injury due to motor vehicle crashes.      We propose to conduct a randomized, prospective study of the effect on the safety, health,     and performance of a police department of a Comprehensive Police Fatigue Management Program     (CPFMP) consisting of the following interventions:        1. identification and treatment of police with sleep disorders;        2. caffeine re-education; and        3. initiation of a sleep, health and safety educational program.      These interventions were chosen because we believe them most likely to lead to measurable     improvements on work hours, health, safety, and job performance, and because they are cost     effective. The success of the CPFMP will be assessed through an experimental comparison with     a standard treatment group that will receive sleep education in the absence of any     accompanying interventions. The overall goal of our team will be sleep health detection and     treatment program that can be disseminated to practitioners, policymakers and researchers     nationwide to reduce police officer fatigue and stress; enhance the ability of officers to     cope with shift schedules; improve the health, safety and performance of law enforcement     officers; and thereby improve public safety.   "
183523|NCT00246064|"     The purpose of the study was to evaluate the ability of a maintenance dosage regimen of     infliximab to achieve and sustain at least 40% improvement from baseline in the total joint     count in patients with active Rheumatoid Arthritis (RA) during methotrexate tapering.   "
183524|NCT00246077|"     This study is being done to see what impact having a Lifeport device has on quality of life     for children with sickle cell who are getting chronic transfusions, from the child's     perspective.   "
183525|NCT00246090|"     The purpose of this study is to evaluate the efficacy and safety of E7389 in Patients with     locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane,     and capecitabine as prior therapy, and who are refractory to the last prior therapy for their     disease.   "
183526|NCT00246103|"     This is a Phase I dose escalation trial with escalating doses of Valproic acid and one dose     escalation step of epirubicin. VPA will be escalated starting at a dose that is recommended     for use as an anti-convulsant or to treat migraine headaches. Epirubicin will be given by     infusion on day 3 after the last dose of divalproex. The study will determine the highest     dose that these two drugs can be given together and as part of a multidrug regimen with     5-fluorouracil and cyclophosphamide.   "
183527|NCT00246116|"     For this companion protocol, we intend to make an assessment of both tumor response and local     tissue effects. Patients undergoing the correlative investigation will be a subset of the     patients already enrolled on the phase II study.   "
183528|NCT00246129|"     The advent of new, potent immunosuppressive (anti-rejection) drugs over the past ten years     has substantially reduced the risk of rejection after kidney transplantation, has allowed the     development of immuno-suppressive regimens that do not use long-term steroids (steroid     avoidance), and has improved transplant success rates both in the short and medium term.      The main new agents used in these modern regimens are the calcineurin inhibitor tacrolimus;     the anti-proliferative agent mycophenolate; and induction agents which are used to provide     effective early suppression of the rejection process; these include monoclonal antibodies     (MoAb) such as IL-2 receptor blocking antibodies (IL-2R MoAb: basiliximab and daclizumab) and     the anti-CD52 antibody Campath-1H (alemtuzumab).      Although almost all modern immunosuppressive regimens involve one or more of these agents, it     is not known which is the safest and most effective combination.      This randomised controlled trial compares two steroid sparing regimens which have been used     with very good short and medium term results at St Mary's Hospital Renal and Transplant Unit     over the last 5 years. The primary hypothesis is that the alemtuzumab/tacrolimus regimen is     as effective and safe as the IL-2R MoAb/tacrolimus/mycophenolate regimen.   "
183529|NCT00246142|"     The purpose of this study is to determine whether electrical stimulation enhances the effect     of botulinum toxin type A (Dysport®) on myofascial pain syndrome.   "
183530|NCT00246155|"     The purpose of this study is to analyse the changes in back muscle size and strength     following use of Dysport®, and to establish whether there is any association between pain     reduction and change in strength, in patients suffering from chronic low back pain.   "
183531|NCT00246168|"     The purpose of this study is to assess the effectiveness of ULTRACETÂ® (a combination     analgesic) as add-on therapy in rheumatoid arthritis patients taking an NSAID (e.g. AdvilÂ®,     MotrinÂ® or other nonsteroidal anti-inflammatory drug) or a COX-2 inhibitor (e.g.     CelebrexÂ®).   "
183532|NCT00246181|"     This clinical trial involves a radiation treatment called stereotactic radiotherapy in     non-small cell lung cancer patients who have been determined to be ineligible for surgery.     This treatment differs from conventional radiotherapy in the number of treatments, the     radiation dose given per treatment, and the way the radiation beams are directed toward the     cancer.   "
183533|NCT00246194|"     The purpose of this study is to examine treatment practices of adult schizophrenia patients     by their own doctors, and to assess patient outcomes when treated with long-acting     risperidone injection over a two-year period of observation.   "
183534|NCT00246207|"     The purpose of this pilot study is to evaluate the safety, tolerability and potential     effectiveness of CONCERTAÂ® (methylphenidate hydrochloride extended-release tablets), a     central nervous system (CNS) stimulant for the treatment of adults with Attention Deficit     Hyperactivity Disorder (ADHD).   "
183535|NCT00246220|"     The purpose of this study is to evaluate the effectiveness and safety of three doses of     prolonged-release methylphenidate (a central nervous system (CNS) stimulant) in adult     patients with attention deficit/hyperactivity disorder (ADHD).   "
185352|NCT00269867|"     The purpose of this study is to evaluate the safety and effectiveness of infliximab (an     anti-TNF chimeric monoclonal antibody [cA2]) in patients with active Rheumatoid Arthritis,     despite methotrexate treatment.   "
183536|NCT00246233|"     The purpose of this study is to evaluate the effects of the addition of CONCERTA®     (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) or placebo in adult     outpatients with Major Depressive Disorder who are currently being treated with oral     antidepressant medication (selective serotonin reuptake inhibitors or selective norepinephine     reuptake inhibitors). The general symptoms of depression will be evaluated, as measured by     the Montgomery Asberg Depression Rating Score (MADRS) on fatigue, energy, and overall     severity of illness. The safety and tolerability of the CONCERTA® and antidepressant     combination therapy will also be assessed.   "
183537|NCT00246246|"     The purpose of this study is to determine the safety and effectiveness of a long-acting     injectable formulation of risperidone in stable bipolar patients randomly switched from their     current add-on oral antipsychotic (olanzapine, risperidone, or quetiapine) therapy to     long-acting injectable risperidone. The patients switched to long-acting injectable     risperidone will be compared to patients who continue on their oral antipsychotic treatment     regimen   "
183538|NCT00246259|"     The purpose of this study is to evaluate the effectiveness, safety and tolerability of     risperidone long-acting injection (LAI) versus oral antipsychotics in participants with     recent onset psychosis (abnormal thinking and/or hallucinations).   "
183539|NCT00246272|"     The purpose of this study is to evaluate the maintenance of clinical effect of a     rapidly-dissolving tablet form of risperidone (an antipsychotic medication) in adult     schizophrenia patients switched from their previous equivalent dose of RISPERDAL® tablets   "
183540|NCT00246285|"     The purpose of the study is to assess the safety and effectiveness of risperidone (an     antipsychotic medication) in adolescents with schizophrenia over 6 months of treatment.   "
183541|NCT00246298|"     The purpose of this study is to determine if PROCRITÂ® (a glycoprotein that stimulates red     blood cell production) initiated at once every 2 weeks dosing is as effective as PROCRITÂ®     initiated at once a week dosing, in increasing hemoglobin levels in anemic HIV-infected     subjects.   "
183542|NCT00246324|"     To evaluate the efficacy, safety, and tolerability of combination therapy with intramuscular     interferon beta-1a and oral doxycycline, a potent inhibitor of matrix metalloproteinases, in     patients with relapsing remitting multiple sclerosis (RRMS) having breakthrough disease     activity.   "
183543|NCT00246337|"     The purpose of this study is to investigate the efficacy and safety of an MK 0974 for     migraine headache and to identify an appropriate dose range for further study.   "
183544|NCT00246350|"     This study will determine the effectiveness of spinal manipulation in reducing pain in people     with chronic headaches accompanied by neck pain. This study will also determine the number of     spinal manipulation treatments necessary for optimal pain relief.   "
183578|NCT00239343|"     The aim of the study is to estimate the effect of preoperative gefitinib on the complete     pathological response rate in primary estrogen receptor negative breast cancer at the time of     surgery.   "
183579|NCT00239356|"     The purpose of this study is to provide aripiprazole to schizophrenic outpatients and     Community Treated Patients who are currently receiving aripiprazole therapy on another BMS     sponsored clinical trial.   "
183545|NCT00238914|"     The overall goal of this research project is to test a newly developed behavioral therapy to     enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone     maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES:        1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of          relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE)          Therapy.        2. Lifetime history of depression will predict dysphoria and non-compliance with          naltrexone.   "
183546|NCT00238927|"     The purpose of this study is to determine, in children aged 1 to 6 years with recurrent     asthma induced by upper respiratory tract infections (URTI), whether the administration of     high doses of inhaled fluticasone started at the onset of symptoms of a cold will result in a     reduced severity and shorter duration of asthma exacerbations and will not be associated with     reduced growth velocity, osteopenia, and adrenal suppression.   "
183547|NCT00238940|"     This extension study is considered to allow patients being treated with EC-MPS to collect     further information on the long-term safety of this drug.   "
183548|NCT00238953|"     Clinical trial for the novo transplant recipients, which aims to assess tolerability and     safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion     (CsA-ME) with or without steroids in a population of kidney transplant recipients.   "
183549|NCT00238966|"     This extension study is considered to allow patients being treated with EC-MPS to collect     further information on the long-term safety of this drug.   "
183550|NCT00238979|"     The aim of this study is whether a switch of stable renal transplant recipients who receive     tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated     mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.   "
183551|NCT00238992|"     All patients of the core study who are interested of being treated with EC-MPS will be     included in an open-label extension study to collect further information on the long-term     safety, tolerability and efficacy of this drug.      The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting     of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo     kidney allograft recipients.   "
183552|NCT00239005|"     This open, multi-center randomized controlled study is designed to investigate the quality of     life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse     events after converting to enteric-coated mycophenolate sodium (EC-MPS).   "
183553|NCT00239018|"     The objective of this extension study is to allow patients being treated with enteric-coated     mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to     assess the long-term safety of EC-MPS   "
183554|NCT00239031|"     All patients of the core study who are interested of being treated with EC-MPS will be     included in an open-label extension study to collect further information on the long-term     safety, tolerability and efficacy of this drug.      The aim of this study is to compare the renal function, 6 months after transplant, in de novo     old-age renal transplant recipients treated with EC-MPS plus reduced dose CsA-ME or with     EC-MPS plus standard dose CsA-ME, both in combination with basiliximab and short-term oral     steroids.   "
183555|NCT00239044|"     To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can     be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months     after switching from MMF to a EC-MPS regimen.   "
185367|NCT00272467|"     The purpose of this study is to evaluate the ulcer healing efficacy of rebamipide in     comparison with omeprazole in Helicobacter pylori-positive gastric ulcer after eradication     therapy.   "
183556|NCT00239057|"     The aim of this study is to evaluate if the addition of EC-MPS to CsA-ME allows the safe     withdrawal of the concomitant corticosteroid therapy in long-term maintenance renal allograft     recipients.      All patients of the core study who are interested of being treated with EC-MPS will be     included in an open-label extension study to collect further information on the long-term     safety, tolerability and efficacy of this drug.   "
183557|NCT00239070|"     This extension study is to assess the long-term safety of EC-MPS   "
183558|NCT00239083|"     The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in     combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients.   "
183559|NCT00239096|"     The purpose of this study is to determine whether losartan, an angiotensin II blocker     prevents the sodium retention in patients with liver cirrhosis and by that reduces the fluid     retention. Moreover is the purpose to asses whether losartan is antifibrotic.   "
183560|NCT00239109|"     -  Various studies suggest that patients treated with Olanzapine can experience a          substantial weight gain, while no changes have been observed in patients treated with          Ziprasidone. Negative consequences on lipid and glucose profiles have also been observed          in patients treated with Olanzapine. Most of the available data belong to short-term          studies. However, for most clinical trials the primary variable was an efficacy          variable, and included the weight assessment as a secondary variable; they also lack a          systematic monitoring of some variables that can play a role in weight gain, as the          level of exercise, appetite increase, etc. and we have considered of importance their          inclusion in this protocol. Previous studies did not assess visceral fat using widely          standardized parameters as the waist index, which at certain levels is considered an          indicator of the cardiovascular risk, or leptine, highly correlated to the body fat          storage. We would like to fit the recently published American Diabetes Association,          American Psychiatric Association, American Association of Clinical Endocrinologists and          North American Association for the Study of Obesity Antipsychotic, obesity and diabetes          mellitus consensus.22        -  Schizophrenic patients show a 4-fold probability to die as a consequence of          cardiovascular problems compared to the normal population. The antipsychotic treatment          can contribute to increase this risk favoring weight gain and the appearance of          cardiovascular risk factors associated to obesity (blood hypertension, hyperlipidemia,          type II Diabetes Mellitus). We intend to obtain a complete cardiovascular risk profile          of patients, as well as its change during antipsychotic treatment, including primary          cardiovascular risk factors in addition to the analysis of markers that have recently          been linked to cardiovascular risk (as reactive protein C).        -  The study will evaluate the risk of hyperglycemia, insulin resistance and Diabetes          Mellitus, and will investigate the association between glucose homeostasis abnormalities          and weight gain in the treated patients. Likewise, adiponectine, secreted from          adipocytes and a possible link between obesity and insulin resistance will be          determined; recent studies show an adiponectine decrease in humans with insulin          resistance and obesity; furthermore, prospective studies have shown these changes could          predict a higher risk of DM development.        -  Changes have been introduced in the complete evaluation of the patient's metabolic and          cardiovascular profiles with the advice, and under the coordination of endocrinologists          after a complete review of the subject   "
183580|NCT00239369|"     The primary objective of this trial is to demonstrate that a fixed dose combination of     telmisartan 80 mg plus hydrochlorothiazide 25 mg (T80/H25) is superior in reducing blood     pressure after eight weeks compared with a fixed dose combination of telmisartan 80 mg plus     hydrochlorothiazide 12.5 mg (T80/H12.5) in patients who fail to respond to six weeks     treatment with T80/H12.5.   "
183561|NCT00239122|"     This project will systematically apply a specialist version of Cognitive Behaviour Therapy     (CBT), known as Recovery Therapy, to a random sample of patients with psychotic disorders.     Previously, the therapy has been developed and efficacy established, but the extent of     applicability to (unselected) mental health service patients is unknown. The main aim is to     establish the extent to which this therapy is acceptable and effective for mental health     service clients. A secondary aim is to develop guidelines for the conduct of such therapy in     public mental health settings.   "
183562|NCT00239135|"     The purpose of this study is :        -  To determine the maximum tolerated dose (MTD) for PEP005 Topical Gel in patients with          actinic keratoses.        -  To evaluate patients for clinical safety        -  To determine the systemic absorption of PEP005 Topical Gel   "
183563|NCT00239148|"     The purpose of the study is to determine whether E1 and G1 are safe and effective in the     treatment of type 1 diabetes.      Type 1 diabetes is an autoimmune disease, in which the immune system attacks pancreatic beta     cells. These cells produce insulin, which regulates blood glucose. The mainstay of current     treatment for type 1 diabetes is dietary control and daily parenteral administration of     insulin.      Recent diabetes research has increasingly focused on pancreatic islet cell replacement,     either by islet cell transplantation or by endogenous regeneration of islet cells. During     fetal development, islet precursor cells proliferate and differentiate into mature beta cells     capable of producing insulin. This process is known as islet cell neogenesis. Islet cell     neogenesis normally ceases around birth, however, the adult pancreas still retains     significant potential for islet regeneration, as shown by tissue repair following pancreatic     injury. Pre-clinical studies have shown that E1 and G1 can re-establish islet cell neogenesis     and increase pancreatic insulin production in diabetic animal models. It is therefore     postulated that treatment with E1 and G1 may produce islet cell regeneration in type 1     diabetic patients.   "
183564|NCT00239161|"     The purpose of the study is to compare the safety and effectiveness of the antibiotic     levofloxacin by administering a higher dose of levofloxacin using a shorter course of therapy     to treat patients with infections of their kidney.   "
183565|NCT00239174|"     The purpose of this study is to assess the effect of SR147778 on weight loss over a period of     24 weeks when prescribed with a hypocaloric diet in obese patients. The secondary objective     is to assess the safety and tolerability of SR147778 and to assess the effect of SR147778 on     several secondary parameters (such as waist, metabolic parameters) over a period of 24 weeks     when prescribed with a hypocaloric diet in obese patients.   "
183566|NCT00239187|"     The purpose of the study is to determine whether E1 and G1 are safe and effective in the     treatment of type 2 diabetes.      Type 2 diabetes is the most common form of diabetes. The disease is characterised by insulin     resistance and a compensated state of hyperinsulinemia. In most individual, hyperglycemia     results from a failure of pancreatic beta cells insulin secretory capacity to adequately     compensate for insulin resistance in peripheral tissues. Treatment for type 2 diabetes is     achieved by dietary control, or a combination of diet and oral hypoglycemic agents or     insulin. As the disease progress, many type 2 diabetic patients eventually require insulin as     primary therapy to achieve glycemic control.      Recent diabetic research has increasingly focused on pancreatic islet cell replacement,     either by islet cell transplantation or by endogenous regeneration of islet cells. During     fetal development, islet precursor cells proliferate and differentiate into mature beta cells     capable of producing insulin. This process is known as islet cell neogenesis. Islet cell     neogenesis normally ceases around birth, however, the adult pancreas still retains     significant potential for islet regeneration, as shown by tissue repair following pancreatic     injury. Pre-clinical studies have shown that E1 and G1 can re-establish islet cell neogenesis     and increase insulin production in diabetic animal models. In type 2 diabetic patients,     treatment with E1 and G1 may result in islet cell regeneration. This therapeutic approach may     improve beta cell function, restore the loss of insulin secretory capacity and also benefit     patients on oral hypoglycemic agents by delaying insulin use.   "
183567|NCT00239200|"     The purpose of this study is the determine whether a new compound, called lapatinib, can be     effective in shrinking cancerous tumors of the esophagus that have recurred or spread     somewhere else in the body. They also want to determine the toxicity of this regimen.     Lapatinib blocks 2 receptors that sometimes are present on cancer cells (called epidermal     growth factor receptor, and the Erb B2 receptor). It is possible that blocking these     receptors may decrease the growth of the cancer cells.   "
183568|NCT00239213|"     The purpose of this study is to clarify the preventive effects of catechin gargling on the     influenza infection.   "
183569|NCT00239226|"     This study is a long-term, prospective, and controlled evaluation of the incidence of     persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction     delay paced with preventive algorithms at the interatrial septum (IAS) versus right atrial     appendage (RAA).   "
183570|NCT00239239|"     The purpose of this study is to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of     darbepoetin alfa administered at a subcutaneous (SC) dose of 0.45 mcg/kg three times weekly     (TIW) in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy.   "
183571|NCT00239252|"     Efficacy and safety is compared between interferon alfacon-1 alone and concomitant dosing of     interferon alfacon-1 and ribavirin in hepatitis C patients.   "
183572|NCT00239265|"     The purpose of this study is to determine whether Tamuslosin is effective in the treatment of     lower urinary tract syndrome with female patients.   "
183573|NCT00239278|"     The purpose of this study is to determine whether the budesonide+formoterol combination is     effective in the treatment of exacerbations of COPD with a main emphasis on investigating the     effects on inflammation and a secondary emphasis on clinical efficacy   "
183574|NCT00239291|"     To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in     patients with non-metastatic prostate cancer   "
183575|NCT00239304|"     To determine the safety and tolerability of gefitinib in combination with cisplatin and     radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.   "
183576|NCT00239317|"     The purpose of this study is to determine whether Tamusulosin is effective in the treatment     of lower urinary tract syndrome with male patients.   "
183581|NCT00239382|"     The objective of this trial was to assess the efficacy and safety of 15 mg meloxicam i.m.     once daily compared with 15 mg meloxicam tablets once daily p.o. in patients with Rheumatoid     arthritis over a time period of 7 days.   "
183582|NCT00239395|"     The objective of this trial was to assess the efficacy and safety of 7.5 mg meloxicam i.m.     once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with     osteoarthritis over a time period of 7 days.   "
183583|NCT00239408|"     Evaluate whether the effect of inhaled tiotropium bromide on the change in trough forced     expiratory volume (FEV1), compared to placebo in patients with chronic obstructive pulmonary     disease (COPD), is affected by smoking status.   "
183584|NCT00239421|"     To compare the efficacy and safety of tiotropium plus formoterol in comparison to salmeterol     plus fluticasone in COPD patients.   "
183585|NCT00239434|"     The objective of this study is to compare the bronchodilator efficacy and safety of once     daily dosing of tiotropium inhalation capsules (18 ?g) and Atrovent? MDI (2 puffs of     ipratropium bromide 20 ?g four times daily) in patients with chronic obstructive pulmonary     disease.   "
183586|NCT00239447|"     Non-inferiority of lung function response to Tiotropium inhalation solution compared to     Spiriva HandiHaler   "
183587|NCT00239460|"     The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough     FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients     with COPD.   "
183588|NCT00239473|"     The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10     mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to     placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary     objective was to compare the safety of tiotropium inhalation solution delivered by the     Respimat to placebo and ipratropium bromide MDI.   "
183589|NCT00239486|"     The purpose of this study was to evaluate the efficacy and safety of different doses of     pramipexole (Sifrol) on subjective and objective symptoms of idiopathic Restless Legs     Syndrome (RLS) and also to determine the optimal dose of pramipexole in patients with RLS by     polysomnography and evaluation of clinical improvement.   "
183602|NCT00239655|"     The purpose of this study is to test MK0812 on disease activity in patients with     relapsing-remitting MS. Disease modifying activity will be assessed by measurement of brain     lesions via MRI brain scans and an open label extension is offered.   "
183603|NCT00239668|"     The purpose of this study is to establish an expected recovery trajectory (recovery model) in     terms of physical and psychological function of the pediatric burn patient.   "
183604|NCT00239681|"     The purpose of this study is to determine the safety and effectiveness of long-term therapy     with rosuvastatin compared with a placebo, and to evaluate whether treatment with     rosuvastatin might be effective in reducing the risk of major cardiovascular events.   "
183605|NCT00239694|"     The purpose of this study is to measure how long the improvement in the immune system lasts     in older people after they have been vaccinated, and to examine the immune response in older     people who get vaccinated a second time.   "
183590|NCT00239499|"     The primary objective of this study is to estimate the comparative bronchodilator effect size     and variability for tiotropium (Spiriva, 18 µg q.d.) with the free combination of salmeterol     (Serevent, 50 µg b.i.d.) and fluticasone (Flixotide, 250 µg b.i.d.) in COPD patients.      International COPD guidelines preserve milder stages of the disease (GOLD stage I and IIa) to     bronchodilators and recommend the addition of inhaled corticosteroids only in those patients     who have a documented spirometric response to inhaled corticosteroids and in patients with a     post-bronchodilator FEV1 of less than 50% predicted, who suffer from frequent exacerbations     requiring oral courses of corticosteroids.      Recently published reports indicate that additional bronchodilator efficacy may be achieved     when a long-acting beta agonist is combined with an inhaled corticosteroid. Steady state     bronchodilation was achieved within one week with the drug combination. However, results of     these studies are not consistent, and since the inclusion criteria employed were different     from those utilised in the previously conducted tiotropium studies, it is difficult to     generalise the observed effects to the general COPD population.      In addition, no comparative data is available on the average response over the 12 daytime     hours when COPD patients are active and in most need of bronchodilation. 12 hours corresponds     to the dosing intervals for both salmeterol and fluticasone.   "
183591|NCT00239512|"     Patent ductus arteriosus (PDA) is one of the most common complications in premature infants.     Successful pharmacological closure of PDA with indomethacin was first reported in 1976. Since     then indomethacin treatment has become the standard or prophylactic treatment for clinically     significant PDA in premature infants. Clinically there is a high incidence of complications     associated with indomethacin treatment, including hypoglycemia, necrotizing enterocolitis, GI     bleeding, extension of IVH. More recently, ibuprofen has been shown to be effective for the     closure of patent ductus arteriosus in premature infants without reducing mesenteric, renal,     or cerebral blood flow.Ibuprofen has been shown to close the ductus in animals without     reducing cerebral,intestinal or renal blood flow. Furthermore, ibuprofen enhanced cerebral     blood-flow autoregulation and had some neuroprotective effect. In recent years, our strategy     of PDA treatment for ELBW infants was essentially early targeted indomethacine treatment     depending on echocardiographic shunt flow pattern of PDA. (Arch Dis Child 1997;77:F36-F40.     Acta Paediatr Tw 1998;39:33-7. and Arch Dis Child 1999;79: F197-F200.) By this regimen,     infants will be eligible for the study if their birth weight less than 1000 gm and if they     had PDA without other structured cardiac anomaly confirmed by echocardiography shortly after     birth (as close as possible to12 hours). After parental informed consent is obtained, infants     will be randomly assigned to two groups based on a double-blined design. INDO group will     receive echocardiographic assessment at interval of 12-24 hours or clinically necessary, and     if the PDA had pulsatile or growing flow pattern, indomethacin is given; if the PDA had flow     patterns other than growing or pulsatile pattern, no treatment is given. The subsequent dose     of indomethacin is according to the echocardiographic flow patterns at interval of 24 hours     from the last dose. When indomethacin was fail to close after the first course, the second     course of another 3 doses of indomethacin or ibuprofen will be given. In spite of infants of     INDO group or IBUO group, if PDA fail to close after 2 courses of treatment, surgical     ligation of PDA would be considered according to the infant’s clinical condition. Our     historical data showed that the incidence of complication was about 30%. Permitting 5% chance     of type I error and 20% of type II error and an absolute reduction of the incidence by 20%,     30 infants in each group is needed to detect a difference. Primary outcome of the assessment     is the closure rate of PDA and the incidence of death or pulmonary hemorrhage. Secondary     outcome is IVH or PVL, NEC, oliguria and CLD. We expect that, by using this treatment     regimen, a high PDA closure rate can be achieved and the survival of very premature infants     may be increased.   "
183592|NCT00239525|"     The purpose of this study is to investigate real time 3-D ultrasound imaging of the brain for     the diagnosis and evaluation of stroke.   "
183619|NCT00239876|"     This study will evaluate the safety and efficacy of FTY720 combined with tacrolimus and     corticosteroids in patients receiving a kidney transplant   "
183593|NCT00239538|"     The primary objective of this study is to demonstrate that telmisartan 80 mg combined with     hydrochlorothiazide 12.5 mg (T80/H12.5) is at least as effective and possibly superior to     valsartan 160 mg combined with hydrochlorothiazide 12.5 mg (V160/H12.5) in lowering mean     ambulatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the last 6     hours of the 24-hour dosing interval at the end of a 10-week treatment period in     mild-to-moderate hypertensive, overweight or obese patients with type 2 diabetes mellitus   "
183594|NCT00239551|"     The purpose of this study is to measure the prostaglandin levels in patients with stress     ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.   "
183595|NCT00239564|"     The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and     carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease     who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release     tablets.   "
183596|NCT00239577|"     This descriptive study will evaluate the safety and immunogenicity of 5 different     formulations of the WRAIR dengue vaccine compared to a placebo.   "
183597|NCT00239590|"     Testosterone has traditionally been regarded as a risk factor for heart disease due to the     fact that males have a higher incidence of this disease than women, at least until the     menopause. However recent studies have shown that men with low levels of testosterone may be     at an increased risk of developing coronary heart disease (furring up of the blood vessels     supplying blood to the heart). Our group has demonstrated a relaxing effect of testosterone     in isolated animal coronary arteries (blood vessels supplying blood to the heart). We have     shown that short-term testosterone administration can increase coronary artery and brachial     artery (blood vessel in the arm) blood flow and can decrease the lack of blood supply to the     heart muscle in men with coronary artery disease. These findings indicate a need for similar     but longer-term studies to investigate the possible beneficial effects of longer-term     testosterone therapy on the heart and blood vessels. Should this treatment be shown to be     beneficial to men with coronary artery disease it may be a useful additional therapy for men     with the furring up of arteries in the heart and the resulting angina.      Aim To investigate our hypothesis that testosterone can beneficially affect myocardial     perfusion, vascular reactivity, metabolic risk factors for coronary heart disease and improve     quality of life in men with low plasma testosterone levels and coronary heart disease.   "
183598|NCT00239603|"     The purpose of this study is to evaluate the effectiveness of the OV-Watch to predict     ovulation while women are taking clomiphene citrate.   "
183599|NCT00239616|"     This is an open-label, multicenter pharmacokinetic study of HD od PD patients receiving     erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push     over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7     days for safety endpoints.   "
183600|NCT00239629|"     The aim of this study is to directly compare the bone forming effects of 20 microg/day of     teriparatide with those of 2 g/day strontium ranelate as measured by the histomorphometric     variables and biochemical bone formation markers after 6 months of therapy in postmenopausal     women with osteoporosis.   "
183601|NCT00239642|"     Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney     disease (CKD) patients   "
183606|NCT00239707|"     The purpose of this study is to test the safety of glucose-dependent insulinotropic peptide     (GIP)/GIP Analog on people with Type 2 Diabetes.   "
183607|NCT00239720|"     hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ     rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe     and effective in psoriatic arthritis patients who are unable to control their arthritis with     methotrexate or azathioprine.   "
183608|NCT00239733|"     Thrombocytopenia occurs when a person's blood has a decreased number of platelets, which are     cells involved in blood clotting. This condition may lead to uncontrolled bleeding and can be     fatal. Thrombocytopenia commonly occurs with hepatitis C virus (HCV) infection or as a result     of standard HCV treatment. Anti-D is an antibody approved by the Food and Drug Administration     (FDA) for the treatment of HIV-related thrombocytopenia. The purpose of this study is to     determine the safety and effectiveness of intravenous anti-D for the treatment of     thrombocytopenia in patients with HCV infection who are starting or already undergoing     treatment with peginterferon alfa-2 and ribavirin. This study will recruit HCV patients both     with and without HIV co-infection.   "
183609|NCT00239746|"     The purpose of this study is to test the effect of ibuprofen on the levels of a number of     different proteins (called biomarkers) in cerebrospinal fluid (CSF), blood, and urine to see     whether ibuprofen can influence certain biomarkers associated with the progression of     Alzheimer's Disease.   "
183610|NCT00239759|"     The goal of MIRAGE is to evaluate the association of genetic and non-genetic risk factors for     Alzheimer's Disease.   "
183611|NCT00239772|"     This study will evaluate the effectiveness of cognitive processing therapy versus prolonged     exposure therapy in treating women with post-traumatic stress disorder (PTSD) brought on by     sexual assault.   "
183612|NCT00239785|"     This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and     corticosteroids in patients receiving a kidney organ transplant   "
183613|NCT00239798|"     This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and     corticosteroids in patients receiving a kidney transplant.   "
183614|NCT00239811|"     This study will evaluate the long term safety and efficacy of FTY720 combined with     cyclosporine and corticosteroids in patients receiving a kidney organ transplant   "
183615|NCT00239824|"     The aim of this study is to evaluate the effect of pelvic floor muscle training in the     treatment of urinary incontinence after radical prostatectomy.   "
183616|NCT00239837|"     This study will determine the efficacy of a parent-involved intervention in preventing     problem behavior in middle school girls who are currently in foster care.   "
183617|NCT00239850|"     The purpose of this study is to evaluate the effects of conservative treatments of obesity     with surgery (gastric bypass).   "
183618|NCT00239863|"     This study will evaluate the safety and efficacy of FTY720 versus mycophenolate mofetil (MMF,     Roche brand) combined with cyclosporine and corticosteroids in patients receiving a kidney     transplant.   "
183620|NCT00239889|"     Calcitonin has been used for many years for treating osteoporosis in postmenopausal women,     and it has been shown that calcitonin reduces pain after spine and hip fracture in women with     osteoporosis. Therefore, this study assesses the safety and efficacy of salmon calcitonin     nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture     healing in postmenopausal women.   "
183621|NCT00239902|"     This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and     corticosteroids in patients receiving a kidney transplant.   "
183622|NCT00239915|"     This is a research study of the investigational drug, Pagoclone, in the treatment of     persistent developmental stuttering (PDS), which includes frequent repetitions or     prolongations of sounds or syllables or words, or frequent hesitations or pauses that disrupt     the flow of speech. Pagoclone is an investigational drug, so it is not approved by the United     States Food and Drug Administration.   "
183623|NCT00239928|"     This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients     with wet-type age-related macular degeneration (AMD), who benefit further treatment and who     want to continue the treatment after completion of the preceding study (A5751010).   "
183624|NCT00239954|"     The purpose of this study is to evaluate the effectiveness, safety and tolerability of an     escitalopram combination treatment compared to single treatments, and to placebo in patients     with major depressive disorder.   "
183625|NCT00239967|"     The purpose of this study is to assess the effect of rimonabant 20 mg on HDL (high density     lipoprotein) cholesterol and on TG (triglycerides) plasma levels over a period of one year     when prescribed with a hypocaloric diet (600 kcal deficit per day) in abdominally obese     patients with atherogenic dyslipidemia (low HDL and/or high TG plasma levels). The secondary     objectives are to evaluate specific metabolic parameters, visceral fat (in selected sites),     safety and tolerability of rimonabant 20 mg.   "
183626|NCT00239980|"     Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term     survival is poor for the majority of women with EOC because many present with advanced     disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but     relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in     survival and is associated with unacceptable toxicity. This phase II, dose-finding, open     label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3     doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based     chemotherapy. The primary outcome is disease response, measured according to Gynaecologic     Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes     include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin     associated with the best response will be tested further in a phase III randomized clinical     trial in the same patient population.   "
183627|NCT00239993|"     This study is designed to compare skin reactions with or without the use of warm compress     prior to performing a Copaxone® injection.   "
183628|NCT00240006|"     To compare the effectiveness of a 90-day Copaxone® adherence enhancement program for a sample     of MS patients who are at high risk of nonadherence and receive support from Shared     Solutions® and their MS Center versus those who receive support only from Shared Solutions®.   "
183629|NCT00240019|"     The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with     diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent     (furosemide) will decrease the urine protein, which is a sign of disease, more than an     angiotensin converting enzyme inhibitor alone.   "
183630|NCT00240032|"     This study is designed to compare injection skin (injection site) reactions when an     antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections.     Patients will be assigned (like a flip of a coin) to take either a placebo or an     antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and     physician will be unaware whether they are taking a placebo or antihistamine during the     study.   "
183631|NCT00240045|"     We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are     mediated in part by diminished circulatory volume and that treatment with midodrine,     octreotide and albumin can improve renal and patient outcomes by restoring effective     circulating volume and systemic perfusion.      Our primary objective is to assess change in creatinine clearance using inulin. We will     enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and     exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR,     albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before,     during, and after initiation of drug and compared.   "
183632|NCT00240058|"     This is a research project to test two study techniques among healthy adults. The procedures     look at how blood flow is controlled by substances in blood vessels.   "
183633|NCT00240071|"     The purpose of this study is to determine if acquired hormone therapy resistance can be     reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate     toxicity of the combination of hormone treatment plus Avastin (Bevacizumab).   "
183634|NCT00240084|"     This research study, funded by Scios, Inc., and conducted by the Cardiology Division of the     Department of Medicine at the University of Rochester School of Medicine and Dentistry     investigates the potential benefit of nesiritide (brand name is Natrecor(TM))in improving     exercise capacity in patients with heart failure (HF). Previous studies have shown beneficial     hemodynamic and neurohumoral effects of nesiritide infusion in the therapy of decompensated     heart failure. Other studies have demonstrated increases in endogenous BNP levels (normalized     for exercise workload) in HF patients during and after exercise. However, trials involving     the measurement of exercise capacity in this population following BNP administration are     lacking. This is an experimental prospective, non-blinded, pilot study with a sample size of     20 patients, all serving as their own controls. This study involves off-label use of the drug     nesiritide (indicated for IV treatment of NYHA Class II and III patients, and this study is     enrolling Class II and III patients) and has received FDA approval, and an IND. Subjects are     recruited from the population of referrals to the Strong Memorial Hospital Heart Failure and     Transplantation clinical service, who meet all the inclusion criteria and none of the     exclusion criteria may participate in the study. Enrolled study subjects perform an exercise     VO2 max test, receive a 24 hour infusion of nesiritide and perform a second exercise VO2 max     test.   "
183635|NCT00240097|"     The primary objective of Part I of the study is to determine tumor response rate of     sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide     /carboplatin in chemotherapy-naïve patients with extensive small cell lung cancer. The     primary objective of Part II of the study is to determine the objective tumor response rate     of irinotecan/oxaliplatin in patients with either refractory disease or who have relapsed to     first line chemotherapy or chemoradiotherapy.   "
183636|NCT00240110|"     This proposal will test the efficacy of a promising pharmacological approach for the     treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized,     double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium     (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing     cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and     bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood     stabilization plus supportive psychosocial treatment.   "
183637|NCT00240123|"     The purpose of the study is to determine if adding Benadryl improves sedation for patients     scheduled to undergo ERCP or EUS procedures.   "
183638|NCT00240136|"     The purpose of this research is to observe the effects of RA over a long period in order to     learn which of the early characteristics of patients' early RA predict future joint damage     and disability. We also investigate whether certain treatments can prevent or slow the     development of joint damage and disability. Additionally, the costs and effects of RA on the     patient are studied in order to improve the methods used to measure these effects. Clinical,     demographic, radiographic, and laboratory measures are taken by the rheumatologist in the     office. In addition, patient questionnaires are mailed & completed by the patient and     returned to the coordinating center at UCLA. All information obtained by these means will be     studied in their effects on early, severe RA.   "
183639|NCT00240149|"     Recent studies of adult intensive care unit (ICU) patients have shown significantly decreased     morbidity and mortality when blood sugar concentrations are closely controlled. The safety     and efficacy of this type of blood sugar management has not been studied in the pediatric ICU     population. Based on the current pediatric literature data as well as our extensive     retrospective study, blood sugar concentrations have a potentially profound role to play     among PICU patients. In preparation for a multi-center randomized control trial, we propose a     prospective feasibility study to evaluate the safety and effectiveness of using an insulin     delivery algorithm to manage blood sugar in the PICU. Our hypothesis for this feasibility     trial is that uniformly monitoring and controlling blood glucose with a     Discrete-Closed-Loop(DCL) insulin delivery algorithm will be an effective, safe, and     consistent means of delivering insulin to manage glucose in the pediatric intensive care     unit.   "
183640|NCT00240162|"     The purpose of this study it to evaluate the efficacy of PTK787/ZK 222584, in inducing at     least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein     levels are < 5 g/dL following high dose chemotherapy (HDCT) and autologous stem cell     transplantation (ASCT).   "
183664|NCT00246402|"     The purpose of this study is to test whether chronic administration of the drug acipimox will     improve hyperlipidemia and insulin sensitivity among HIV infected patients experiencing     highly active antiretroviral therapy (HAART) associated metabolic disturbances.   "
183641|NCT00240175|"     Foot orthotics or shoe inserts are currently utilized as a common conservative treatment     option for a wide variety of foot disorders. This treatment is used for both the relatively     healthy active population and the more sedentary population with diabetes or peripheral     vascular disease (dysvascular). However, there is limited objective scientific data     documenting the actual benefits or effectiveness of either customized or over-the-counter     foot orthoses. It is the aim of this study to determine the effects of three popular foot     orthotics on plantar pressures in diabetic populations. If foot orthoses can be utilized as a     preventive treatment option to reduce the risk for foot ulceration by redistributing plantar     pressures, then orthoses would be a cost effective solution to a high cost (mental and     fiscal) medical impairment.   "
183642|NCT00240188|"     The purpose of this research is to compare open ventral incisional hernia repair to the     laparoscopic repair with respect to complications, recurrence, pain, return to normal     activities of daily living, and return to work.   "
183643|NCT00240214|"     The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under     everyday conditions   "
183644|NCT00240227|"     This double-blind placebo controlled crossover pilot trial will test the hypothesis that     prazosin, an alpha-1 adrenergic receptor antagonist, reduces craving for their drug of choice     in cocaine-dependent and alcohol-dependent veterans. Both the study medication period and the     placebo period are each 4 weeks in duration.   "
183645|NCT00240253|"     The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an     established regimen of insulin glargine in subjects with type 2 diabetes who are not     achieving glycemic targets.   "
183646|NCT00240266|"     The purpose of this study is to investigate the effect of treatment with rosuvastatin on the     capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting     step in reverse cholesterol transport.   "
183647|NCT00240279|"     To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in     hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)   "
183648|NCT00240292|"     The purpose of this study is to assess the effect of rosuvastatin (up-titrated to a dose of     40mg/day) compared to placebo on cardiac remodelling, estimated by change in left ventricular     ejection fraction on radionuclide ventriculography, at 26 weeks post randomisation from     baseline.   "
183649|NCT00240305|"     The purpose of this study is to investigate the dose-related effect of treatment with     rosuvastatin on production and fractional catabolism of apolipoprotein A-I (apoA-I) and     apolipoprotein A-II (apoA-II), and on the plasma apoA-I, apoA-II and high-density lipoprotein     cholesterol (HDL-C) concentration.   "
183650|NCT00240318|"     The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce the     atherosclerosis (fatty deposits) in your arteries   "
183651|NCT00240331|"     The purpose of this study is to see if rosuvastatin helps to reduce the number of heart     attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.   "
183652|NCT00240344|"     The purpose of this study is to determine the efficacy of Crestor in high risk patients     switched from higher doses of other statins in obtaining the new European Atherosclerosis     Society (EAS) low-density lipoprotein cholesterol (LDL-C) guidelines.   "
183653|NCT00240357|"     The purpose of the study is to determine whether an Internet based compliance tool is     superior to common diet counselling in patients with hypercholesterolemia.   "
183654|NCT00240370|"     The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic     control on metformin alone, have a similar, or not inferior, glycemic response when treated     with the combination of muraglitazar and metformin compared to pioglitazone and metformin.   "
183655|NCT00240383|"     A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the     Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes   "
183656|NCT00240396|"     The purpose of this prospective randomized study is to evaluate the risks and benefits of     using bimodal analgesia, (i.e. Narcotics and NSAIDS) vs Narcotics alone post long bone     fracture.   "
183657|NCT00240409|"     The objective of this study was to investigate the efficacy and safety of Pramipexole Tablets     in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly) in a     single blind, comparative method using Bromocriptine tablets as comparators (phase III     comparative trial)   "
183658|NCT00240422|"     The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan     or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow     (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion.   "
183659|NCT00240435|"     The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10     mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to     placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary     objective was to compare the safety of tiotropium inhalation solution delivered by the     Respimat to placebo and ipratropium bromide MDI.   "
183660|NCT00240448|"     The primary objective of this study is to compare the effectiveness of telmisartan 80     mg/hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg/hydrochlorothiazide 25 mg     [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.   "
183661|NCT00246363|"     There is some information available that indicates that Milk Thistle is an effective     treatment for liver disease. This study will compare Milk Thistle with a placebo, (a medicine     that looks just like Milk Thistle but does not contain any Milk Thistle) to see if people     with both Hepatitis C and HIV infections show improvement or cure of Hepatitis C. The study     will last one year.   "
183662|NCT00246376|"     This study will evaluate the efficacy of diet and exercise (DE), with and without niacin and     fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or     dyslipidemia.   "
183663|NCT00246389|"     The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl     5 mg (muscle spasm medication) taken three times a day, alone or in combination with     ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the     treatment of back or neck muscle pain with muscle spasm.   "
185368|NCT00272480|"     To determine whether the use of two antiviral agents in combination will be better than     placebo in the treatment of an inflammatory sidease of the spinal cord caused by HTLV-I   "
183665|NCT00246415|"     The purpose of this study is to obtain a preliminary indication of the safety and     effectiveness of oral memantine (40 mg/day) in alcohol dependent patients. This study is a     16-week study comparison of memantine and placebo in patients with alcohol dependence.   "
183666|NCT00246428|"     The purpose of this study is to determine whether motivational interviewing is effective in     reducing alcohol consumption and alcohol problems among young adults who present to an     Emergency Room.   "
183667|NCT00246441|"     The purpose of the study is to determine whether an SSRI, paroxetine, improves social anxiety     symptoms and alcohol use in individuals who drink to cope with social anxiety disorder.   "
183668|NCT00246454|"     The purpose of this study is to determine the properties of circadian rhythms and sleep     propensity in familial advanced and delayed sleep phase syndrome (DSPS).   "
183669|NCT00246467|"     One hundred and five subjects will be recruited into three groups. Each subject will receive     two doses of recombinant plague vaccine at one of three dose levels (rF1 and rV recombinant     antigen proteins).   "
183670|NCT00246480|"     Respiratory syncytial virus (RSV) causes sickness and deaths in older people every winter.     This study will investigate how aging affects the body's immune response (body's response to     disease) to RSV. About 2000 people, age 21 and older, who reside in the upstate NY area, will     be recruited. Two groups of subjects will be studied. The 1st group of volunteers will be     recruited prior to the start of RSV season in year 1 of the study. These volunteers will     include healthy people and people with various medical conditions. The 2nd group of     volunteers will be patients admitted to Rochester General Hospital for acute respiratory     illness. Procedures will include drawing blood from a vein in the arm (2 tablespoons),     collecting nasal swabs, and collecting sputum. Volunteers may participate in study related     procedures for up to 3 years.   "
183684|NCT00246662|"     This study primarily determined the safety and tolerability of escalating doses of vosaroxin     (SNS-595) in 2 dose schedules, and assessed the PK profile of vosaroxin and defined a     recommended dose regimen for Phase 2 studies. Secondarily the study assessed potential     biomarkers and antileukemic activity.   "
183685|NCT00246675|"     The purpose of the project is to test whether or not the commonly used medication frusemide,     given after heart surgery, and aiming to increase urinary output can have an effect on kidney     function.   "
183686|NCT00246688|"     The purpose of this study is to determine if this epothilone leads to a response in patients     with recurrent ovarian cancer that has progressed during, or in the last six months since a     treatment of platinum-based chemotherapy. We also aim to look at the safety of the study drug     and assess the impact of the infusion duration on tolerability.   "
183699|NCT00247741|"     The purpose of this study is to compare two short-acting local anesthetics, articaine and     lidocaine, for spinal anesthesia in day-case surgery. The onset time of the sensory- and     motor block, recovery time until discharge and complications will be studied.   "
183671|NCT00246493|"     The prevalence, incidence, and severity of atherosclerotic disease all markedly increase with     age. Basic experimental and observational data demonstrate that aging magnifies the     pathologic and clinical consequences of established risk factors and is the most potent     individual risk factor for coronary atherosclerosis and for adverse outcomes following an     ischemic event. These findings suggest that normal aging alters the vascular substrate so as     to promote the development and progression of atherosclerosis. The age-associated changes in     vascular structure and function include an increase in central vascular stiffness, intimal     proliferation, and endothelial dysfunction. The major hypothesis is that the above     alterations in vascular substrate (i.e. vascular age) are an important determinant of the age     associated increased likelihood for the development and progression of coronary     atherosclerotic disease.      This program will non-invasively characterize vascular age and atherosclerotic burden in BLSA     participants and individuals with successful aging, i.e. those with no or minimal evidence of     coronary atherosclerotic disease, and those with premature, clinically evident coronary     artery disease. It will repeat measures of vascular age and atherosclerotic burden three     years after the first assessment. By examining the impact of vascular age on the initial     extent and the progression of atherosclerotic burden over a two to three-year period, it will     test the hypothesis that vascular age is an important determinant of the ageassociated     increase in atherosclerotic disease.   "
183672|NCT00246506|"     This study will determine the most effective treatment strategy for infertile couples who     present when the female partner is 38 years to the 43rd birthday and the couples are     determined to have a reasonable chance for success.   "
183673|NCT00246519|"     There are many medications available for the treatment of high blood pressure (hypertension),     but finding the right one for a specific patient can be challenging. In fact, it is estimated     that only 34% of people with hypertension have their blood pressure under control. The     hypothesis is that genetic differences between individuals influence their response to     antihypertensive medications. This study is aimed at determining the genetic factors that may     influence a person's response to either a beta-blocker or a thiazide diuretic. The hope is     that through this research, we may someday be able to use an individual's genetic information     to guide the selection of their blood pressure medicine, leading to better control of blood     pressure, and less need for the current trial and error process.   "
183674|NCT00246532|"     Opiates such as morphine are the cornerstone medications for the treatment of moderate to     severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become     more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that     analgesic tolerance to opioids (habituation) develops during chronic use even though this     phenomenon has never been prospectively studied. Our specific aims propose to prospectively     test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent     tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and     hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced     hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance     and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study     will be the first quantitative and prospective study of tolerance and hyperalgesia in pain     patients and will have important implications for the rational use of opioids in the     treatment of chronic pain.   "
183675|NCT00246545|"     The aim of the study is to evaluate the effect of early onset of exercise training (ET) after     myocardial infarction (MI) in a randomized controlled trial. Usual care is to wait 4-6 weeks     after onset of MI, and our hypotheses are that early ET will prevent a fall in VO2peak and     contribute to better quality of life.   "
183676|NCT00246558|"     The purpose of the study is to investigate the prevalence of pain in the anterior part of the     knee, amongst youngsters between 16 and 18 years of age.      Furthermore, this trial intends to study the connection between the pain, hyperpronation of     the foot and tight Achilles tendon.      We want to find out if there is a need of an early effort in terms of information, training     and/or support for the shoes.   "
183677|NCT00246571|"     The purpose of this study is to compare progression free survival for SU011248 [sutent     (sunitinib malate)] versus standard of care therapy in patients with previously treated,     advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast     cancer.   "
183678|NCT00246584|"     This study will evaluate the safety and efficacy of long term treatment of SPP100 in patients     with essential hypertension. (Trial is not recruiting in the US)   "
183679|NCT00246597|"     The purpose of this study is to determine whether it is possible to measure temporary     difficulty with thinking and/or short-term memory in women who are receiving chemotherapy for     early stage breast cancer and to determine whether or not treatment with PROCRITÂ® will help     decrease any problems with thinking or short-term memory that chemotherapy may cause.   "
183680|NCT00246610|"     This study is an evaluation of the safety of 625 mg formulation when administered to     HIV-infected pregnant women from their second trimester through six weeks postpartum. The     study will also evaluate the pharmacokinetics of VIRACEPT   "
183681|NCT00246623|"     This study will examine how to dose Exubera (inhaled insulin) in patients who are not well     controlled on two or more diabetes pills. This study should show that a large number of     patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that     have been set by the American Diabetes Association (ADA). Target goals should be achieved by     adjusting the Exubera dose either weekly or twice weekly. Patients will also receive     nutritional counseling and diabetes education as part of the study.   "
183682|NCT00246636|"     The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid     ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of     patients with very high triglycerides.      The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of     adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects     treated with fenofibrate in lowering serum triglyceride (TG) levels.   "
183683|NCT00246649|"     An autologous peripheral stem cell or bone marrow transplant may be able to replace     blood-forming cells that were destroyed by chemotherapy. Using stem cells or bone marrow     cells that are treated in the laboratory may be an effective treatment for acute leukemia.      This clinical trial is studying how well an autologous stem cell transplant using specially     treated cells works in treating patients with acute leukemia.   "
183687|NCT00247572|"     This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to     learn if NRP104, when injected into a vein, produces a high and any other effects like     amphetamine and other stimulant drugs that are abused. This information will give some     indication if NRP104 can be abused. Healthy people, between the ages of 18 and 55 with     histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs     that are used most often to treat attention deficit hyperactivity disorder (ADHD) in     children, to treat narcolepsy (excessive sleepiness) and for weight loss.   "
183688|NCT00247585|"     The objective is to investigate residual effects of heavy drinking, with or without hangover     symptoms. The primary aim is to test several hypotheses about residual effects of heavy     drinking. Hypotheses about how heavy drinking affects next-day performance include direct     physiological effects of alcohol, alcohol withdrawal effects, and non-ethanol effects, such     as congeners, or family history of alcohol problems. The investigators will test the     following hypotheses:        1. relative to placebo, heavy drinking will degrade next-day performance, and this          relationship will be mediated in full or in part by quality of sleep;        2. a high congener alcoholic beverage will affect performance to a greater degree than a          low congener beverage and this relationship will be mediated by severity of hangover          symptoms.   "
183689|NCT00247611|"     This study will develop and evaluate the efficacy of an individualized, interactive, computer     software program delivered in conjunction with clinical care in increasing and supporting     antiretroviral therapy adherence in HIV-infected individuals.   "
183690|NCT00247624|"     This study will evaluate the safety and effectiveness of treatment with both a sleeping pill     and antidepressant medication in improving sleep and psychological functioning in people with     depression and insomnia.   "
183691|NCT00247637|"     This is a study of the genetic basis of brain dysfunction in people with schizophrenia.   "
183692|NCT00247650|"     This study is to measure the extent of tumor shrinkage when Letrozole and Zoledronic Acid are     given before surgery to newly diagnosed post-menopausal women with early breast cancer   "
183693|NCT00247663|"     - To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole     monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer     which participated in double blind study.   "
183694|NCT00247676|"     The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and     then further 25 patients up to a total of 63 eligible patients. If the study gives good     results it can be expanded to a total of 160 patients. SU011248 will be administered orally     daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg [milligrams] with     provision for dose reduction based on tolerability. All patients will receive repeated cycles     of SU011248 until disease progression, occurrence of unacceptable toxicity, or other     withdrawal criteria are met. After discontinuation of treatment, patients will be followed up     in order to collect information on further antineoplastic therapy and survival   "
183711|NCT00247910|"     The objective of the study is to determine whether psychological therapy (self-help or     individualized intense stress management) is different than a single drug treatment in terms     of their effectiveness for lowering blood pressure.   "
183712|NCT00247923|"     The aim of these studies is to study the natural history, the symptoms of, as well as the     effect of hysteroscopic resection of endometrial polyps. Furthermore, another aim is to study     new diagnostic techniques to differentiate between malignant and benign endometrial polyps.   "
183695|NCT00247689|"     Background:        -  Research has shown that several human genes have been associated with vulnerability to          substance abuse and dependence. However, little is known about how people with these          genetic tendencies react to drugs in controlled settings.        -  Methylphenidate, also known as Ritalin, is commonly prescribed for a number of          conditions, including attention deficit disorder. Because methylphenidate is widely used          in studies of brain chemistry and behavior and has relatively low risks associated with          it use, researchers are interested in seeing how it affects the thinking processes of          people with apparent genetic vulnerability to drug abuse.      Objectives:      - To evaluate whether individuals with apparent genetic vulnerability to drug abuse react     differently to methylphenidate than people who do not have this vulnerability.      Eligibility:      - Individuals at least 18 years of age or older who have participated in the NIDA protocol     Allelic Linkage in Substance Abuse.      Design:        -  Participants will be asked to avoid using a number of over-the-counter medications,          including antihistamines, cough medicines, and nasal decongestants, for 24 hours before          the study day. Participants will also be asked to avoid consuming caffeinated beverages,          nicotine or tobacco products, or alcohol on the morning of the day of the study, and          will provide a urine sample at the start of the study to be tested for chemicals that          may interfere with the study.        -  Because of the nature of the study drug, participants will not be allowed to drive to          the clinical center on the day of the study. (Return transportation will be arranged.)        -  At the start of the study, participants will take two tablets (each 1 hour apart), and          will not be told whether the tablets are the study drug or a placebo.        -  Participants will give regular answers to questions about mood and thinking processes on          a computer for approximately 5 hours. Blood samples will be taken during this part of          the study.   "
183696|NCT00247702|"     Oral warfarin anticogulation for the prevention and treatment of patients with venous     thromboembolism is one of the most used therapies in clinical practice. Patients require     different dosage to achieve the target therapeutic anticoagulation. Optimal dosage and     bleeding complication are two most clinical concerns. Besides of multiple individual factors     (e.g. age, dietary intake, vitamin supplement, drug compliance etc.), some genetic factors     may determine the drug requirement and safety.      The cytochrome P450 CYP2C9 is a liver enzyme required for the oxidative metabolism of     warfarin. The vitamin K epoxide redutase (VKOR) is a liver enzyme associated with the reuse     of the oxidative hydroquinone form of vitamin K. The VKOR enzyme is the target of warfarin.     Recent studies revealed both genes may determine the pharmacodynamic of warfarin     anticogualation. To date, there are more than thirteen identified polymorphism at CYP2C9     gene. Majority of those variant polymorphisms may decrease the warfarin requirement. The VKOR     complex subunit 1 (VKORC1) is a newly identified gene. Some polymorphisms also were reported.      As we know, the Chinese patients need a lower dosage of warfarin in comparison with the     Caucasian patients. We are interested in finding the genetic causes of Taiwneses Chinese     patients. In our study we will first identify the polymorphism patterns of these two genes in     normal population. Then, we will try to find the association between these polymorphism and     patient warfarin requirement. Our pharmacogenetics study will be valuable for prevention of     bleeding complication of warfarin treatment in Chinese population.   "
183697|NCT00247715|"     The purpose of this study was to determine which treatment strategy, the step-up or the     step-down treatment strategy, is the most cost-effective treatment for patients with new     onset dyspepsia in primary care.   "
183700|NCT00247754|"     Objective:        1. To evaluate the efficacy of a school-based cognitive behavior therapy (CBT) program in          reducing anxiety disorder symptoms in at-risk public school children.        2. To determine whether parent education and involvement improves outcome in anxious          children treated with CBT.        3. To determine the ability of school personnel in a) recognizing classroom behaviors as          anxiety disordered after targeting training of observable child behaviors e.g.,          avoidance, over-worry, etc.), and b) delivering a cognitive behavior intervention and        4. To evaluate a new measure of teacher-rated anxiety disorder symptoms in children.      Hypothesis:        1. A CBT oriented intervention as delivered by school personnel will be superior to an          attention control procedure in reducing anxiety symptoms in at-risk children.        2. Children who have parental involvement will post stronger and more enduring treatment          gains.   "
183701|NCT00247780|"     Atrial fibrillation (AF) is the most common cardiac arrhythmia. Pulmonary vein isolation     (PVI) in the left atrium using radiofrequency energy is a new and promising non-medical     treatment in patients with symptomatic AF with reported success rates of 65 % to 90 %     depending on AF classification and ablation procedure. However, the risk of recurrence has     led to suggestions of how to improve the clinical outcome by tailoring a more efficient     ablation procedure. A prospective, randomised study with 150 patients with symptomatic AF     referred for PVI has been initiated and patients are allocated to PVI alone (75 patients) or     PVI with additional ablation in the right atrium (75 patients). Patients undergo extensive     monitoring of the heart rhythm during follow-up to document symptomatic or asymptomatic AF or     atrial flutter. The presence of asymptomatic AF after PVI could potentially affect the     management of the anticoagulation therapy in these patients. The structural and functional     changes in the atria after PVI is characterized by new imaging techniques (Tissue Doppler     Imaging(TDI))of the atria and cardiac neurohormones. TDI may be an effective tool for     characterising changes in the left atrial function after PVI. Neurohormones may provide new     information regarding the changes in left atrial function and clinical outcome after PVI in     patients with AF.      We hypothesize that:        -  Among patients with predominant atrial fibrillation, PVI with additional ablation in the          right atrium is associated with better outcome, i.e. freedom of symptomatic AF/atrial          flutter overall.        -  Asymptomatic AF and atrial flutter occur frequently after PVI.        -  Left atrial volume and systolic function correlates to AF recurrence after PVI.        -  Neurohormones levels correlates to AF recurrence after PVI.   "
183724|NCT00248092|"     This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to     learn if NRP104 produces a high and any other effects like amphetamine and other stimulant     drugs that are abused. This information will give some indication if NRP104 can be abused.     NRP104 is an investigational drug. This means that it has not been approved by the U.S. Food     and Drug Administration (FDA). Healthy people, between the ages of 18 and 55 with histories     of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are     used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to     treat narcolepsy (excessive sleepiness) and for weight loss.   "
183702|NCT00247793|"     Effect of two preoperative oral immune-enhancing nutritional supplements in patients at high     risk of infection after cardiac surgery: a randomized placebo-controlled study.      Introduction: In our first study we showed that the use of a preoperative oral     immune-enhancing nutritional supplement (OIENS) resulted in an improved patients’     host-defence with a reduction in postoperative infectious morbidity in ‘high-risk’ cardiac     surgery patients. The use of the OIENS resulted also in less postoperative organ dysfunction.     Experimental studies have shown that additional glycine results in less ischemia-reperfusion     damage and that glycine has anti-inflammatory properties.      Objective: The use of an OIENS in the preoperative period in patients at high risk of     infection after elective cardiac surgery with the use of cardiopulmonary bypass (CPB) results     in a reduction in infections as in our first study. The addition of 9.6 gram glycine per     sachet OIENS results in a further reduction in postoperative dysfunction.      Design: A prospective randomized placebo controlled study with two oral immune enhancing     nutritional formula’s and an isocaloric control formula. Patients: Seventy-four consecutive     patients undergoing cardiac surgery with the use of an CPB who met one or more of the     following inclusion criteria: Age 70 years or older, mitral valve replacement or cardiac     ejection fraction less then 40%. Exclusion criteria were age < 18 years, proven malignancy,     use of corticosteroids, severe renal and liver failure. Definition of a protocol violation     was the intake of less then 5 L or more then 10 L of the nutritional supplement in the     preoperative period.      Intervention: Patients were split up in three groups by concealed randomisation. One group     received the arginine, omega3-PUFAs and nucleotides enriched formula (OIENS). Another group     received the OIENS further enriched with glycine (OIENS+glyc). The control group received an     isocaloric nutritional supplement without the enrichments.   "
183703|NCT00247806|"     It is currently assumed that all patients are lactose intolerant post bone marrow     transplantation. This pilot study is to assess what the incidence of lactose intolerance is     after bone marrow transplantation in children. This will be done using a lactose breath test.   "
183704|NCT00247819|"     This investigation seeks to better define the genetic basis for vulnerability to substance     abuse.   "
183705|NCT00247832|"     This study aims to examine the relationship between the patient's perception of readiness for     discharge after lobectomy and mobilization rates, frequency of visitation by family and     friends, anxiety levels and pain levels. We will test the hypotheses that a) those patients     who walk farther early after surgery and who have more visitors and decreased anxiety and     pain levels will have a greater self-perceived readiness for discharge and b) that patients     who receive daily ambulation goals and personal motivation will have higher step rates, and     therefore have a greater self-perceived readiness for discharge, than those that do not. We     will monitor patients, during the post-operative recovery period using pedometers to count     steps taken, visitor log sheets, and questionnaires on the patients' anxiety, pain and     perceived readiness for discharge. Furthermore, we will examine how the patient's     self-perceived readiness for discharge is affected by study interventions which include     ambulation goals and daily personal motivation.   "
183728|NCT00248144|"     The study is designed to assess the efficacy and safety of patient-initiated therapy with     famciclovir 1500 mg o.d. or 750 mg b.i.d. for one day treatment in adult men and women with     recurrent herpes labialis   "
183729|NCT00248157|"     This multicenter, open-label extension study will evaluate the long-term tolerability and     safety for patients completing study CSMS995 0802. During this extension study, all patients     will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2     years for the treatment of moderately severe to severe NPDR and low risk PDR.   "
183730|NCT00248170|"     Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females     who recently underwent primary surgery for breast cancer. Patients will be randomized to     letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up     will occur for 5 years after the completion of enrollment for survival and disease status     updates.   "
183706|NCT00247845|"     With the advent of highly active antiretroviral therapy (HAART), it was hypothesized that its     consistent use could lead to a cure for HIV infection in as little as three years [Perelson,     1997]. Subsequent research has shown this model to be incorrect [Finzi, 1999]. In addition,     long term use of HAART has now been associated with significant metabolic abnormalities,     which could lead to unintended morbidity, possibly worse than what one could expect from the     progression of untreated HIV-associated immune disease over the same period of time [Carr,     2000]. Accordingly, current recommendations for antiretroviral therapy have become more     conservative. It is now suggested that a person with a CD4 count > 350 cells/mm³ may safely     delay initiation of HAART [Yeni, 2002].However, for those who still require HAART, the risks     of short-term and long-term toxicities remain, even if full virologic suppression is     achieved. In this setting, a number of switching strategies have been evaluated (Negredo et     al, 2002 & Martinez et al, 2003), mostly involving single drug substitutions of a protease     inhibitor (PI) for a non-nucleoside agent (NNRTI) or abacavir (ABC). In general terms, these     hae shown that virologic suppression is usually maintained, with improvement in drug-related     side effects, including metabolic toxicities. A number of patients who are currently taking     effective HAART are experiencing side effects to one or more of the agents in their regimen     that is not severe enough to mandate an immediate change in their regimen, but that is having     a measurable effect on their qualify of life. Over time, these effects may have an impact on     adherence to therapy and its long-term efficacy. Given the recent availability of ATV     (+/-RTV), its once daily administration, low pill count and favourable side effect profile,     it is being used in clinical practice as part of single drug substitution strategies in     patients exhibiting a maximal response to HAART. There is a clear need to examine this     practice in a systematic manner to document its occurrence, efficacy and safety.      We hypothesize that, in patients with maximal virologic suppression on a double class regimen     (including two NRTIs and an NNRTI or a PI, boosted with RTV or not), and in whom a decision     has been made to implement a single drug substitution of the NNRTI or PI for ATV (+/-), this     will lead to an improvement in objectively measured quality of life without any negative     impact on the virologic efficacy of the regimen.   "
183707|NCT00247858|"     To analyze microbiological data from MRSA samples obtained through the emergency department     from 2001-2005. There is a strong clinical suspicion that we are now seeing an outbreak of a     new strain of MRSA and we plan to better characterize the Vancouver population and complete a     chart review to assess specific associated factors.   "
183708|NCT00247871|"     We plan to compare data from 300 nasal swab in Vancouver's Downtown Eastside taken in 2001 to     data obtained in 2005. The nasal carriage rate of MRSA and the specific characteristic of     each MRSA found will be analyzed. A limited amount of associated information will be obtained   "
183709|NCT00247884|"     The treatment of HCV-infected IDUs presents multiple challenges, such as adherence to     therapy, relapse of substance use, re-infection, and co-morbid psychiatric disease. Some     guidelines recommended that IDUs not be offered HCV treatment until they had stopped all such     use for > 6 months, raising some questions about fairness and discrimination. Little     published data exist on HCV therapy in active IDUs. However, extensive evidence exists that,     when specific programs are developed, IDUs can be successfully engaged in care. In IDUs,     strategies shown to improve adherence include directly-observed therapy (DOT), cash     incentives, and comprehensive case management. Weekly interferon dosing now provides a means     of improving HCV treatment adherence, and makes a DOT approach more practical. Within an     observational, prospective clinical cohort, we will be able to identify a group of IDUs     infected with HCV genotype 2 or 3 who would most benefit from treatment for their infection.     We will design a systematic approach to the determination of their appropriateness for     treatment, refine the approach to their treatment within a directly observed therapy (DOT)     setting, and evaluate the success of the approach (defined as the achievement of Sustained     Virologic Response (SVR)). Taken together, this project will help define a systematic     approach to HCV infection in the inner city. The hypothesis is that the development of a     systematic approach for the diagnosis of HCV and the establishment of a directly observed     therapy (DOT) program for the treatment of HCV infection in IDUs will constitute an effective     means of controlling the epidemic of this infection within this population.   "
183710|NCT00247897|"     The purpose of this study is to compare the current standard skin disinfectant solution for     labour epidurals used at BC Women's Hospital to another common skin disinfectant and to the     skin disinfectant solution recommended by the Public Health Agency of Canada (PHAC) prior to     placing special intravenous lines. There is very little information available to guide     doctors in deciding which is the best skin disinfectant for epidural analgesia. The study     hypothesis is that the disinfectant solution recommended by the PHAC will be the most     effective.   "
183713|NCT00247936|"     Esophagectomy for benign or malignant disease of the esophagus can be performed using a     transhiatal technique or Ivor Lewis technique (combined laparotomy with thoracotomy). These     procedures can be associated with significant morbidity and mortality [1]. Advances in     minimally invasive technology and surgical techniques have allowed us to explore the     possibility of performing esophagectomy using minimally invasive surgical techniques.      Minimally invasive esophagectomy represents a new alternative to conventional open     esophagectomy. It is a technically demanding operation requiring advanced laparoscopic     surgical skills, appropriate instrumentation, and thorough knowledge of open esophagectomy.     Multiple authors have reported the use of video-assisted thoracoscopy or laparoscopy to     facilitate esophagectomy [2-6]. Most of these reports have utilized a standard laparotomy in     combination with thoracoscopy to perform esophageal mobilization or laparoscopy with a     mini-laparotomy to perform esophagectomy. DePaula was the first to report a large series of     48 patients undergoing laparoscopic transhiatal esophagectomy for benign (n=24) and malignant     disease (n=24) [7]. In 2 patients, conversion to open surgery was required and 2 others     required thoracoscopic assistance. Postoperative complications were low in the benign group     but higher in the carcinoma group. The 30-day mortality rate was 16% in patients with     carcinoma undergoing laparoscopic transhiatal esophagectomy. DePaula concluded that the     patients who benefit most from this procedure are those with benign disease. Swanstrom     recently reported nine cases of laparoscopic total esophagectomy [8]. There were no     conversions to laparotomy. One patient required a right thoracoscopy with intrathoracic     anastomosis due to poor viability of the gastric tube. The mean operative time was 6.5 hours     with a mean hospital stay of 6.4 days. However, the advantages of minimally invasive     esophagectomy have not been observed. The aim of this prospective trial is to evaluate the     physiologic outcome, clinical outcome, and quality of life after combined thoracoscopic and     laparoscopic esophagectomy vs. transhiatal esophagectomy.   "
183714|NCT00247949|"     Arterial carbon dioxide partial pressure (PaCO2) is an essential indicator of ventilation and     respiratory function. It is routinely tested invasively by arterial blood gas analysis (ABGA)     but recently developed miniaturized carbon dioxide tension sensors promise non-invasive and     continuous transcutaneous PCO2 (PtcCO2) monitoring. We, the researchers at University     Hospital, Basel, Switzerland, determined the accuracy of two PtcCO2 monitors (TOSCA 500 with     Sensor 92, Linde Medical Sensors AG, Basel; and Sentec Digital Monitor with V-Sign Sensor,     Sentec AG, Therwil) for measurement of single values and trends in PaCO2 in critically ill     patients, using ABGA as a reference.   "
183715|NCT00247962|"     The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the     treatment of Ankylosing Spondylitis.   "
183731|NCT00248183|"     This is a randomized, double-blind, placebo controlled, multi-center outpatient study, in     adults with GAD.      Patients 18-65 years of age, with the diagnosis of GAD according to DSM-IV criteria, who     fulfill the inclusion/exclusion criteria, will be enrolled in this study.   "
202056|NCT00492466|"     This study is to find out if Interferon-beta can recover its effectiveness in patients with     Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.   "
183716|NCT00247975|"     Breast cancer is very common and afflicts 1 in 9 North American women. The treatment of     breast cancer often requires the use of chemotherapy including anthracyclines.     Anthracyclines can damage the heart resulting in heart failure and even death. Clinicians and     researchers are continually seeking methods that will reduce the toxic effects of     anthracycline treatment.      L-carnitine is a substance that is produced naturally in the body and is required for normal     heart function. Animal studies have suggested that L-carnitine protects the heart from the     effects of anthracyclines, however this has not been verified in humans.      This study will assess the potential role of L-carnitine in the prevention of anthracycline     induced heart damage. The investigators will enroll 144 patients into this study. Patients     will be randomly assigned to L-carnitine therapy or to standard care (no L-carnitine     therapy). Patients in the L-carnitine group will receive oral and intravenous L-carnitine     prior to and after their anthracycline therapy. Patients will undergo regular follow up and     testing to assess heart function. The investigators believe that patients treated with     L-carnitine will benefit and have fewer complications associated with anthracycline     treatment.   "
183717|NCT00247988|"     Weekly carboplatin and taxotere will be tolerable and effective as second line treatment of     platinum-sensitive ( >6 month treatment free interval) relapsed ovarian cancer      Primary efficacy parameter will be response rate (CR and PR) according to RECIST criteria.      Secondary endpoints will be duration of response, progression free survival and overall     survival. Toxicity will also be evaluated.   "
183718|NCT00248014|"     This investigation aims at distinguishing the subjects that react in a favorable way to the     treatment protocol we propose for the Class II treatment   "
183719|NCT00248027|"     Main Research questions:        1. Who are the patients referred for treatment at the Psychotic Disorders Clinic?        2. What are the outcomes from treatment for first episode psychosis in multiple outcome          domains?        3. What hospital resources are used over the early course of the illness?        4. How satisfied are patients and family with the treatment and services they received?          This is an important study that will help us evaluate the service and treatment offered          by the Psychotic Disorders Clinic's specialized early intervention program,which helps          young people experiencing early stages of psychotic illness.A growing body of evidence          suggests that intervening earlier in the course of the illness with specialized and          complimentary pharmacological and psychosocial treatment may be associated with improved          outcomes.   "
183720|NCT00248040|"     The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear     neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin     is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and     efficacy of reparixin in preventing the delayed graft function (DGF) after kidney     transplantation.   "
183721|NCT00248053|"     The purpose of this study is to assess if curcumin, a commonly used food spice, can regress     colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited     form of colorectal cancer.   "
183722|NCT00248066|"     The process of re-narrowing of a coronary artery following a revascularization procedure such     as angioplasty, begins at the time of the procedure. Restenosis has long been considered a     major problem for effective long-term interventional success. This often results in repeated     procedures to deal with recurrent stenosis (or restenosis) of the original targeted vessel.      There is a substantial body of literature suggesting that local MYC protein production in the     injured coronary artery is a major stimulus and potential cause of restenosis that appears     after stent placement. This study is based upon the hypothesis that stopping MYC protein     production in the vessel will help reduce restenosis (vessel re-narrowing).      AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that     interferes with MYC production.      This study will evaluate the safety and potential effectiveness of RESTEN-MP to reduce     in-stent restenosis following balloon angioplasty and stent placement. The post-dose     follow-up period is up to six-months.      RESTEN-MP is administered at the time a stent is successfully placed in a coronary artery,     and again 24 hours later, via slow-push intravenous administration.   "
183723|NCT00248079|"     To evaluate the clinical safety, efficacy, and pharmacokinetics (PK) of the Endeavor Resolute     Zotorolimus Eluting Coronary Stent System for the treatment of single de novo lesions in     native coronary arteries with a reference vessel diameter (RVD) between 2.5 and 3.5 mm in     diameter.   "
183725|NCT00248105|"     Arthritis is a major cause of disability. Of the nearly 70 million persons in the US with     arthritis and/or chronic joint symptoms, nearly 8 million are disabled because of their     arthritis. Knee osteoarthritis (OA) and rheumatoid arthritis (RA) are two of its most common     and disabling forms. Despite evidence that physical activity can improve functional and     health related quality of life (HRQOL) outcomes and lower health care costs, the proportion     of the US population engaging in the recommended amount of physical activity is low and even     lower among those with arthritis. Moreover, there is considerable variation in clinicians'     promotion of physical activity for arthritis clients. Care providers infrequently ask clients     about their physical activity behavior and report feeling unprepared to promote physical     activity.      This application studies the effects of a behavioral intervention aimed at promoting physical     activity, including lifestyle physical activity, on arthritis-specific and generic HRQOL     outcomes. The proposed physical activity management program (PAM) is based on a chronic care     model in which allied health professionals promote patient self-management activities outside     of traditional physician office encounters. The program is an individualized counseling and     referral intervention, conducted by physical activity managers, directed by a theory-based     comprehensive assessment of individual patient barriers and strengths related to physical     activity performance. The specific aims of this randomized, controlled trial of 480 clients     with RA and knee OA followed for 24 months are to test the effectiveness of physical activity     management combined with physician physical activity promotion (PAM group) compared to     physician physical activity promotion only (control group) in improving arthritis-specific     and generic HRQOL, observed measures of function, and objectively measured and self-reported     physical activity levels. In addition, exploratory analyses will be done to assess whether     the improvements in HRQOL and physical activity performance associated with the PAM program     are mediated by increases in physical activity levels and theory-based motivational     variables, respectively. This study is intended to generate feasible methods by which health     care providers and health care systems can increase physical activity levels in clients with     arthritis and to result in widely applicable strategies for health behavior change.   "
183726|NCT00248118|"     The purpose of this study is to determine: 1) the short-term clinical efficacy and safety of     bupropion for helping adolescent tobacco smokers quit, and 2) The role of withdrawal symptoms     in the maintenance of smoking in adolescents.   "
183727|NCT00248131|"     This multicenter, open-label extension study will evaluate the long-term tolerability and     safety for patients completing study CSMS995 0802. During this extension study, all patients     will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2     years for the treatment of moderately severe to severe NPDR and low risk PDR.   "
194054|NCT00385931|"     This study will assess and compare the efficacy and safety of valsartan and the combination     of valsartan and simvastatin in patients with high blood pressure and high cholesterol.   "
183732|NCT00248196|"     Coronary heart disease is the single leading cause of death in the United States. In 2000, it     was implicated in 681,000 deaths (1 in every 5 deaths). Myocardial infarction (MI) is the     major cause of death in patients dying of coronary heart disease, with an estimated incidence     of 1.1 million new and recurrent cases per year. It is well established that reperfusion is     the most successful treatment for salvaging myocardium during acute infarction. However,     despite such treatment, a substantial number of patients still remain at risk of developing     large infarcts, with reduced left ventricular function and increased mortality. Therefore,     adjunctive therapies that are designed to reduce ischemic metabolism and cellular injury     pending successful reperfusion, or to protect myocytes against the undesired effects of     reperfusion (reperfusion injury), should be beneficial in limiting infarct size. Mild     hypothermia is one such potential therapy. This study has been designed to evaluate whether     the adjunctive use of mild hypothermia further reduces the extent of heart damage caused by a     heart attack.   "
183733|NCT00248209|"     A recently completed multi-site double-blind placebo-controlled study found that bupropion     (Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a     diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain     whether bupropion will improve orgasmic function in pre-menopausal women with a primary     complaint of idiopathic orgasmic disorder who do not have hypoactive sexual desire disorder.     This will be a multicenter, placebo-controlled, double blind study of women with a diagnosis     of female orgasm disorder. During a baseline visit, psychiatric, medical, alcohol and drug,     and sexual histories will be obtained. Patients who continue to meet screening     inclusion/exclusion criteria at their baseline visit will be randomly assigned to either     placebo or bupropion XL for 8 weeks. A flexible dosing paradigm will be used. Sexual desire     and activity will be assessed by patient diaries, investigator interview of sexual     functioning every two weeks, and by standardized questionnaire every four weeks. The primary     endpoint will be the increase in orgasm completion as measured by the Changes in Sexual     Functioning Questionnaire-F (CSFQ-F). Secondary endpoints will be changes in sexual arousal,     sexual desire, and sexual pleasure as assessed by the CSFQ-F.   "
183734|NCT00248222|"     The purpose of this study is to examine the feasibility and efficacy of an early supervised     aerobic exercise program for patients following a minor ischemic stroke.   "
183735|NCT00248235|"     The purpose of this study is to investigate the effect of a progressive therapeutic exercise     program on specific physical and functional deficits in the neck and shoulder region     occurring as a result of head and neck cancer treatment.   "
183736|NCT00248248|"     The primary objective for this study is to evaluate the development, frequency and severity     of hand foot syndrome (HFS) in ovarian cancer subjects treated with Doxil®, as consolidation     therapy, on an every two week schedule.      The secondary objective for this study is to assess one-year progression free survival rate     (PFS).   "
183737|NCT00248261|"     Serotonin re-uptake inhibitors, such as sertraline, are the medication of choice in     post-traumatic stress disorder. However, it takes several weeks before they ameliorate     symptoms. Therefore, we will add ziprasidone (vs. placebo) medication during the first four     weeks of sertraline in order to find out if this strategy accelerates symptomatic relief.   "
183738|NCT00248274|"     Over the past decade, techniques have been refined which permit an enormous amount of     information relevant to disease mechanisms to be gained from the examination of heart tissue.     The Cardiovascular Institute has extensive experience with these techniques, and has utilized     them to examine other heart disease substrates.      In this study, the investigators propose to obtain heart tissue at the time of cardiac     surgery which would otherwise be discarded. Their plan is to examine this tissue and     correlate their findings with clinical data. Their hope is that the proposed study will     provide insight into atrial physiology, including the molecular mechanisms underlying atrial     disease and the potential development of atrial fibrillation (AF).      This will be a prospective registry for atrial tissue. The investigators propose an     enrollment of 300 subjects, to take place at University of Pittsburgh Medical Center (UPMC)     Presbyterian over a 5 year period.   "
183739|NCT00248287|"     The purpose of this study is to determine the objective response rates produced by irinotecan     and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer.   "
183740|NCT00248300|"     The purpose of this study is determine if a single, early dose of chlorhexidine applied     within 12 hours after endotracheal tube insertion will reduce the bacteria in the oral cavity     and the incidence of pneumonia in trauma victims.   "
183741|NCT00248313|"     To assess equivalence in the rates of functional graft survival at 12 months after     transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and     Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus     induction with CsA and Rapamune® followed by discontinuation of CsA and     concentration-controlled Rapamune®.   "
183742|NCT00248326|"     The investigators' goal with this research is to:        1. Establish a clinical database and a DNA bank for 1000 individuals with AF and 1000          individuals without AF.        2. Directly test the hypothesis that known functional polymorphisms in the coding sequences          and the promoter regions of cardiac genes (ion channels and genes known to affect          survival in the setting of left ventricular dysfunction) predispose individuals to AF.      Over the past decade, advancing techniques and technologies for gene characterization have     yielded significant clues as to the molecular mechanism of certain human heart rhythm     disorders. The role of ion channel polymorphisms in subjects with AF is unknown. Similarly,     it is also not known whether polymorphisms in other genes have an impact on the risk of AF.      The ability to characterize genomic at-risk profiles would have many potential benefits for     patient care. Paramount among these is:        1. Increased oversight or intervention of at-risk subjects, which might prevent unnecessary          morbidity and mortality due to AF.        2. Further insight into the pathogenesis of AF, which may lead to preventative or curative          therapies.   "
183743|NCT00248339|"     The purpose of this study is to determine if the use of epoetin-alpha will allow patients     with chronic hepatitis C virus infection to be treated with higher doses of     peginterferon-alpha-2b and ribavirin, thus increasing chances at lower viral levels and     raising sustained virologic response.   "
183744|NCT00248352|"     The purpose of this study is to compare two ways to treat patients with Type 2 Diabetes,     Standard Care or Case-Managed Care.      In-Patient Standard Care is guided by the assigned cardiologist and Out-Patient Standard Care     by the existing diabetes care givers.      Case-Managed care involves a consult with an endocrinologist and counseling from a diabetic     educator and a dietician.   "
183745|NCT00248365|"     The purpose of this study is to assess the tolerability and safety of two intensity levels of     Theralux extracorporeal photochemotherapy in the treatment of subjects with steroid     refractory or intolerant GvHD.      The current hypothesis is that apoptotic cells re-injected into patients induce an     immunomodulation effect alleviating the GvHD symptoms. Using the Theralux procedure, the dose     of photodynamic treatment may be modulated to achieve the maximal immunomodulatory effects in     the treated patients.      The intervention is iterative extracorporeal photochemotherapy of autologous peripheral blood     mononuclear cells (PBMC) with a rhodamine-derivative TH9402 (drug) and Theralux (device).   "
183746|NCT00248378|"     The purpose of this study is to determine whether or not smoked marijuana improves spasticity     in patients with multiple sclerosis.   "
183747|NCT00248391|"     Supine feeding position is associated with serous otitis media. The hypothesis is that supine     feeding is associated with recurrent otitis media, tonsillar and adenoid hypertrophy and     recurrent pneumonia secondary to recurrent aspiration.   "
183748|NCT00248404|"     The purpose of this trial is to assess the tolerability and safety of NB1011 in the treatment     of patients with cancers that overexpress TS, such as ovarian, gastrointestinal, colorectal,     bladder, breast, and lung cancers.   "
183749|NCT00248430|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. An     autologous stem cell transplant using the patient's stem cells may be able to replace     blood-forming cells that were destroyed by chemotherapy. Giving white blood cells from a     donor may help the patient's body destroy any remaining cancer cells. Interleukin-2 may     stimulate the white blood cells to kill cancer cells.      PURPOSE: This phase I/II trial is studying the side effects of donor white blood cell     infusions and interleukin-2 and to see how well they work in treating patients who are     undergoing an autologous stem cell transplant for relapsed advanced lymphoid cancer.   "
183750|NCT00248443|"     The MiniMax® study is a multicenter randomized controlled study aimed at demonstrating that a     combination of non-invasive diagnostic tools are as effective as fiberoptic bronchoscopy and     bronchoalveolar lavage (FO-BAL) in performing the etiological diagnosis of acute respiratory     failure in cancer patients.   "
183751|NCT00248456|"     This study will evaluate the efficacy and safety of calcipotriol plus betamethasone     dipropionate ointment compared with calcipotriol ointment in the treatment of patients with     psoriasis vulgaris for a duration of 4 weeks. The study will focus on the percentage change     of the psoriasis area and severity index (PASI) from baseline to the end of week 4.   "
183770|NCT00248729|"     The objective of this study was to compare the utility of etomidate and midazolam in helping     patients to relax when there was a need for the placement of a ventilation tube by medics who     were transporting patients to a hospital in an ambulance.   "
190807|NCT00347087|"     To test whether treatment with the angiotensin II receptor antagonist Irbesartan improves     insulin sensitivity and metabolic profile in patients with chronic heart failure.   "
183752|NCT00248469|"     The MEMA kwa Vijana Project is a community randomised trial which aims to assess the impact     of a targeted intervention on adolescent sexual and reproductive health in Mwanza Region,     Tanzania. The intervention aims to reduce HIV, STD and unwanted pregnancy amongst adolescents     by improving reproductive health knowledge and by teaching skills to promote sexual behaviour     change, and comprises community mobilisation, skills-based education in primary schools, and     youth friendly health services. The evaluation includes a detailed process evaluation, and     evaluation of the impact in a cohort of approx. 10,000 adolescents who will be followed for 3     years.   "
183753|NCT00248482|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor     from coming back.      PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan     and cisplatin works in treating patients with extensive-stage small cell lung cancer.   "
183754|NCT00248495|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) and giving them     before and after surgery may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin     before and after surgery works in treating patients with stage I, stage II, or stage III     non-small cell lung cancer.   "
183755|NCT00248521|"     RATIONALE: Drugs used in chemotherapy, such as     17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating     patients with metastatic solid tumors or tumors that cannot be removed by surgery.   "
183756|NCT00248534|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as temozolomide and methylprednisolone, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Rituximab may help     chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs.     Giving rituximab together with temozolomide and methylprednisolone may be an effective     treatment for primary CNS non-Hodgkin's lymphoma.      PURPOSE: This phase II trial is studying how well giving rituximab together with temozolomide     and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkin's     lymphoma.   "
183757|NCT00248547|"     RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help     lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant.      PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and     dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone     in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.   "
183758|NCT00248560|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel     works in treating patients with persistent, recurrent, or metastatic head and neck cancer.   "
183759|NCT00248573|"     This is an observational, natural history trial of mechanisms of gut adaptation in adult     short bowel syndrome (SBS). Patients with SBS (< 200 cm small bowel ± colon) will be studied     initially 2-9 months after the last small bowel resection and again exactly 6 months after     the initial study. GCRC-studies will examine intestinal nutrient absorption, gut barrier     functions and gut mucosal biopsy specimens for markers of nutrient transport and cell     proliferation and apoptosis.   "
183760|NCT00248586|"     An accumulating body of evidence indicates that a specific psychological treatment called     cognitive behavioral therapy (CBT) is associated with significant reductions in pain and     bowel dysfunction of irritable bowel syndrome (IBS). Despite its apparent efficacy, the     clinical effectiveness of CBT (i.e., its generalizability, feasibility, cost effectiveness)     has not been adequately established due partly to its duration, cost, and limited     accessibility. As the second generation of IBS treatments undergo development and     validation, it has become increasingly clear that efficacy demonstration is a necessary but     not sufficient condition of treatment viability. One potential solution to the problem of     clinical effectiveness is to develop a briefer, largely self administered version of CBT that     retains the efficacy of standard CBT but is more transportable, accessible, and less costly     to deliver. To this end, a two-stage project is proposed. The goals of the first stage will     be to develop, refine, and pilot test an innovative limited therapist contact-CBT protocol     patterned after treatments proven effective for painful medical disorders with similar     pathophysiology as IBS. The primary aim of the second stage is to conduct a small randomized     clinical trial (N = 75 patients meeting Rome II diagnostic criteria) of standard (10 session)     version of CBT (S-CBT) and limited contact (4 session) version of CBT (LC-CBT) with reference     to a wait list control to examine their comparative efficacy on multiple indices, including     IBS symptoms (primary outcome variable), psychological distress, and quality of life.     Secondary aims are (1) to identify patient characteristics that predict outcome; (2) obtain     information regarding active change-inducing mechanisms that may underlie treatment outcome;     and (3) obtain information regarding possible monetary benefits, cost-effectiveness, and     cost-benefit of S-CBT versus LC-CBT protocols. Data from this trial would set the stage for     an R01 funded multicenter study with a large, random, and representative sample that could     establish the clinical effectiveness of LC-CBT and in so doing make a significant     contribution toward more efficient and effective care of IBS.   "
183771|NCT00248742|"     Patients with ulcerous colitis and Crohn's disease, age 18-60, with a relapse within the last     18 months and an activity index ≥4, with a long time stress level ≥60 on the perceived stress     questionnaire (PSQ) were randomized to a stress management intervention program or treatment     as usual and followed up for 18 months.   "
183772|NCT00248755|"     The objective of this study is to determine the effect of airway surface liquid (ASL) volume     on mucociliary clearance in cystic fibrosis (CF). A two-isotope nuclear medicine technique     will be utilized. This pilot trial will include the imaging of n=7 CF subjects and n=7     healthy subjects. The trial will include one study visit per subject that will take     approximately 3 hours. Hypothesis: The simultaneous imaging of both a floating and a     penetrating radioisotope tag will allow the relative effect of airway surface liquid volume     on mucociliary clearance to be determined when evaluated in CF and normal subjects.   "
183761|NCT00248612|"     The proposed project is written as a typical clinical practice test and is a     fully-controlled trial of a combined anxiety-focused CBT and pharmacotherapy (venlafaxine;     CBT-VEN) delivered for patients with comorbid alcohol-use and anxiety disorders. The CBT and     pharmacotherapy will be contrasted with relaxation training and placebo medication. One     hundred and eighty participants will be recruited and, subsequent to a platform of outpatient     treatment for alcoholism, will be randomly assigned to a 12-week treatment condition. All     treatment conditions will begin with a 1-week placebo run-in, after which participants will     begin a trial of venlafaxine or placebo. The treatments will conclude with a 2-week     medication/placebo taper. Follow-up assessments will be conducted at post-treatment and at 3,     6, 9, and 12-months. The long-term objectives of this research are to develop a real-world     combination of psychosocial and pharmacological treatments for patients with comorbid     alcohol-use and anxiety disorders that compromise prognosis, and to evaluate the     effectiveness of combined psychosocial and pharmacological treatments that target anxiety     among patients with this comorbidity.   "
183762|NCT00248625|"     We have completed patient enrollment in the the double blind, randomized, placebo-controlled     trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of     non-acetaminophen ALF. The purpose of this study is to examine the safety and efficacy of     intravenous NAC in children with ALF for whom no antidote or other specific treatment is     available. Inclusion in the NAC Study required enrollment in the Pediatric Acute Liver     Failure (PALF) Study Registry.   "
183763|NCT00248638|"     Relative glutamine (GLN) deficiency may contribute to morbidity and mortality in surgical     intensive care unit (SICU) patients. During critical illness, GLN utilization by the immune     system, gut mucosa and other tissues exceeds endogenous production and plasma GLN     concentrations decrease, which may contribute to cellular dysfunction and increase nosocomial     infection risk and mortality. Conventional GLN-free parenteral nutrition (PN) has a limited     impact on SICU outcomes and does not repair the GLN deficit. Our recent pilot data show that     GLN dipeptide-supplemented PN decreases nosocomial infections and improves clinical outcomes     in SICU patients. The process of benefit is poorly understood, but animal and human data     suggest that GLN treatment correlates with a) up-regulation of cytoprotective molecules in     blood and tissues [e.g, GSH, specific heat shock proteins (HSPs) and GLN]; and b) improved     epithelial barrier defenses and immune cell number and function. Properties of L-GLN limit     provision in solution, but the GLN dipeptide alanyl-GLN (AG) confers stability and solubility     in PN (AG-PN). We propose a multicenter, double-blind, randomized, controlled phase III trial     based on our pilot data to test the hypothesis that AG-PN improves clinical outcomes in SICU     patients requiring PN after cardiac, vascular or colonic operations. Subjects will receive     either standard GLN-free PN or isocaloric, isonitrogenous, AG-PN until enteral feeds are     established. Specific Aim 1 is to determine whether AG-PN decreases hospital mortality,     nosocomial infection and other important indices of morbidity. Specific Aim 2 is to obtain     novel, mechanistically relevant observational data in the Aim 1 subjects on whether AG-PN a)     increases serial blood levels of GSH, HSP-70 and -27, and GLN; b) decreases the presence in     serum of the bacterial products flagellin and LPS and the adaptive immune response to these     mediators; and c) improves key indices of innate/adaptive immunity. This study is designed to     delineate the clinical benefit of a major new nutrition support strategy in high-risk SICU     patients.   "
183764|NCT00248651|"     Functional dyspepsia is a common gastrointestinal disorder. Symptoms can include stomach pain     or discomfort, bloating, fullness after eating meals, and nausea. These symptoms often     interfere with school and work, and weight loss may occur due to dietary restrictions.      The hypothesis of this study was that antidepressant therapy is more effective than placebo     in relief of the symptoms of functional dyspepsia, adjusting for psychological and     psychiatric co-morbidity. The study also examined if antidepressant therapy reduces     disability and improves quality of life in functional dyspepsia.   "
183765|NCT00248664|"     EPIC is a case/control study that seeks to identify the risk factors for interstitial     cystitis by comparing the experiences and medical histories of 400 women who recently     developed IC with 400 similar people who do not have the disease.   "
183766|NCT00248677|"     Project STORY (Sensible Treatment of Obesity in Rural Youth) will entail a three-arm     randomized controlled trial to test the effectiveness of interventions designed to promote     successful weight management in an important population, overweight children and their     parents in medically underserved, rural settings. The current feasibility study will provide     pilot data to develop and support a full-scale trial that will be implemented across multiple     rural counties. In this pilot program, participants will be randomly assigned to one of two,     4-month long intervention programs that will be delivered in rural communities through     Cooperative Extension Offices, or to a Wait List Control (WLC) group. The Behavioral     Family-Based Intervention (BFI) will involve simultaneous, but separate treatment groups for     both the child and their parent(s). The Behavioral Parent-Based Intervention (BPI) will     involve groups for only the parent(s). Both programs will take a behavioral lifestyle     approach to gradually modify dietary and physical activity patterns. The aims of the trial     and its principal hypotheses are listed below.      AIMS:        -  Evaluate the effects on child's standardized body mass index (BMI-z) of BPI and BFI          delivered via group contacts to overweight children and/or their overweight parents in          rural counties.        -  Examine changes in children's dietary intake, physical activity, self-esteem, and body          image.        -  Compare the cost-effectiveness of the BPI and BFI.        -  Evaluate the effects of the BPI and BFI on parent BMI.   "
183767|NCT00248690|"     The purpose of this study is to determine whether treatment guided also by ICP mean wave     amplitude improves outcome compared to international standard care in patients with SAH.   "
183768|NCT00248703|"     The purpose of this study is to identify patients with persisting tumor cells after standard     epirubicin-containing treatment to test a non-cross resistant chemotherapy regimen     (docetaxel) for these patients, and to explore the analysis of disseminated tumor cells in     bone marrow as a surrogate marker for clinical outcome.   "
183769|NCT00248716|"     Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three     groups:        1. Iron deficiency with no anemia        2. anemia        3. no anemia and no iron deficiency Following a nutritional questionnaire, parents of all          toddlers will receive instruction regarding appropriate nutrition in the 2nd year of          life. Groups 1 and 2 will randomly receive one of two preparations currently in use for          treatment of iron deficiency in Israel (Aktiron 35 - Ferrous gluconate and Ferripel-3 -          iron polysaccharide complex). Followup blood count will be taken 3 month after          recruitment. The study aims to compare the effectiveness of the Iron preparations          regarding compliance and efficacy.      The hypothesis is that a significant difference will be detected between the two     preparations.   "
183773|NCT00248768|"     The purpose of this study is to determinate if accelerated rTMS treatment over 1.5 days is     effective for ameliorating depression in Parkinson's disease.   "
183775|NCT00248794|"     The study will investigate the viability of two cognitive rehabilitation strategies to     improve functional outcomes for people with schizophrenia. Many people with schizophrenia     experience impairments in cognitive function which limit their abilities. These impairments     have been shown to precede the onset of illness and represent a vulnerability factor which is     exacerbated by emerging psychotic symptoms. These impairments affect a range of functional     domains including symptom severity, work function, symptom management, treatment, and overall     quality of life. Recognizing the link between cognitive impairment and function, a few     clinicals and researchers have attempted to remediate cognitive impairments by providing     cognitive retraining programs similar to those used in traumatic brain injured patients or     adaptive skills training. Cognitive retraining involves repetitive exercises to increase     elemental cognitive functions including memory, attention, psychomotor speed, planning, and     cognitive flexibility. Adaptive skill training involves didactic group exercises in social     skills, activities of daily living, and symptom management. Each approach has demonstrated     some rehabilitation benefits. This study will investigate the effectiveness of a combination     of these two approaches on outcomes in schizophrenia.   "
183776|NCT00248807|"     The purpose of this study is to determine how blood pressure and blood flow are controlled     during head-up tilt in a semi-upright position. In this investigation we are studying blood     pressure and blood flow to the brain, with and without a medication which lowers blood     pressure (Vasotec). We will determine how persons with a spinal cord injury are able to     maintain blood flow to the brain (not get dizzy) as they assume a more upright position and     their blood pressure decreases.   "
183777|NCT00248820|"     This study intends to assess the ability of contrast-enhanced ultrasound in the detection of     benign and malignant ovarian masses compared to unenhanced ultrasound.      By using an intravascular contrast agent, this noninvasive and feasible imaging technique     will allow the investigators to define specific microcirculation patterns in 100 women with     ovarian lesions.      The intravascular contrast agent properties will be compared between benign and malignant     adnexal masses.      The final purpose of this ultrasonography is to allow the early detection of tumors and to     improve the characterization between benign and malignant lesions.   "
183778|NCT00248833|"     The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76     MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from     meningitis.      This study will vaccinate three groups of people. In the first 2 groups, the study will be     double-blinded. This means that neither the volunteer or the medical team will know which     formulation of the vaccine was administered. The third group of volunteers and the medical     team will know that they are receiving the higher dose of the vaccine.   "
183779|NCT00248846|"     The long-term objective of this study is to determine whether a positive affect and     self-affirmation condition added to an empirically demonstrated approach for motivating     behavior change is more effective than a standard approach in reducing risk factor behavior     among a high-risk group of patients with coronary artery disease. Thus, the goal of the     project is to refine and improve strategies for long-term maintenance of physical activity     among patients post-angioplasty or stent.   "
183780|NCT00248859|"     This is an observational study among Latino patients who have coronary artery disease. The     goal of the study is to determine the association between having depressive symptoms and the     ability to modify one's health behavior. Specifically, participate in physical activity.   "
183781|NCT00248872|"     The long-term objective is to determine whether better adherence to prescribed medications     can be achieved through positive affect induction and self-affirmation leading to reduction     in hypertension-related outcomes such as end-stage renal disease, stroke, and cardiovascular     mortality among African American patients with poorly controlled hypertension.   "
183782|NCT00248885|"     It is the long term objective of this study to preserve or improve the quality of life and to     prevent deterioration in physical and mental function following myocardial revascularization     among bypass surgery patients.   "
183783|NCT00248898|"     Long term follow-up of nonagenarians who have undergone open heart procedures.   "
183784|NCT00248911|"     Women with breast cancer and other gynecologic cancers often suffer significant distress and     disability from their disease. A practice of meditation-based stress reduction and     cognitive-affective-behavioral learning may help women with these conditions decrease their     suffering and improve their quality of life.   "
183785|NCT00248924|"     The objective of this prospective study is to document the impact of social service     interventions (including meals, telephone reassurance, and friendly visiting)provided by the     Burden Center, a model community social service agency, on overall quality of life.   "
183786|NCT00248937|"     We will conduct an empirical test of the two intervention approaches under study.     Specifically, we seek to determine the potential differential impact of positive affect     induction and self affirmation.   "
183787|NCT00248950|"     We are interested in achieving an empirical test of the two intervention approaches under     study. Specifically, we seek to determine the potential differential impact of positive     affect induction and self affirmation following the qualitative study phase.   "
183788|NCT00248963|"     To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of     LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100     mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.   "
183789|NCT00248976|"     The objective of this randomized trials is to evaluate, among coronary artery disease     patients who have just had either angioplasty or stents, whether a novel intervention based     on feedback of individualized risk profiles framed as the opportunity to reduce one's     biological age is more effective after two years in reducing mortality and major     cardiovascular morbidity (specifically, myocardial infarction, stroke, class II-IV angina,     and severe ischemia) than the standard risk reduction approach, which is framed as one's     opportunity to reduce future risk. The novel strategy is based on the theory of net-present     value and is tested in coronary artery disease patients who have a high risk of adverse     outcomes by two years.   "
183790|NCT00248989|"     The purpose of the study is to determine the response of skin parameters related to skin     aging to the local action of DHEA in postmenopausal women.   "
183791|NCT00249002|"     This study is designed to confirm the safety of the proposed dose and schedule of ABI-007 for     hemodialysis patients with vascular access device failure, and to obtain preliminary data on     the effectiveness of such treatment.   "
183792|NCT00249015|"     Endurance exercise such as walking has been shown to help breast cancer survivors maintain     their energy and quality of life while they are receiving chemotherapy, but there have not     been any studies on weight training. In this study, the researchers want to determine if a     combined program of endurance and weight training exercises is better than a standard amount     of endurance exercise or even a higher amount of endurance exercise in breast cancer     survivors receiving chemotherapy. The study will be an experimental design in which the     researchers have breast cancer survivors participate in one of the three different exercise     programs. The researchers' main interest is in patient rated physical functioning and quality     of life, which they will measure before and after the exercise programs by asking     participants how they feel on various rating scales. The researchers will also measure their     aerobic fitness on a treadmill and how strong they are by having them lift weights.   "
183793|NCT00249041|"     The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects     with Rheumatoid Arthritis   "
183794|NCT00249054|"     This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The     performance of the devices will be assessed by:      Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse     of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines.      Biopsies: Metal ions, cytokines and histology. Biomechanics: Strength, gait analysis, range     of motion. Scanning: DEXA and MRI   "
183795|NCT00249067|"     This is a retrospective chart review examining our experience with carvedilol in CHF     secondary to left-to-right heart shunt lesions. The treatment group will be children who have     received carvedilol. The control or comparison groups will be patients who have received     either digoxin/furosemide or captopril for this indication. Charts will be reviewed of     patients who have been treated at Children’s Healthcare of Atlanta and as outpatients by     Sibley Heart Center Cardiology between September 2000 and October 2005. Patients will have     been started on carvedilol prior to April 1, 2005 and only information up to October 1, 2005     will be used for this study. We will review approximately 50 charts for this study.      We will evaluate the effectiveness of these medications at reducing symptoms of CHF.   "
183818|NCT00249379|"     The purpose of this study is to test how tolerable and effective acamprosate is when used to     prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in     drug court).   "
183842|NCT00249704|"     The study will explore multiple mobility function tests as well as functional and     neuropsychological tests in elderly subjects at risk for falls and disability, before and     after 4-month exercise and/or Vitamin D intervention.   "
183796|NCT00249080|"     Neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, and multiple     sclerosis are recognized as a major health concern at the present time. There is information     in magnetic resonance imaging (MRI) studies regarding the role of brain iron in normal brain     aging that may be enhanced with the use of better scanning equipment and procedures, and by     correlating this information with clinical data. This research study aims to develop and     evaluate a number of techniques that can potentially improve the effectiveness of three tesla     (3T) magnetic resonance imaging of neurodegenerative brain disorders.   "
183797|NCT00249093|"     The aim of the study is to evaluate effects of supplementary oxygen during exercise on     dyspnoea and exercise tolerance in COPD-patients given long-time oxygen treatment   "
183798|NCT00249106|"     The purpose of this study is to determine the safety and immune response to a investigational     DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), at three different dosage levels,     in adults who are not infected with HIV.   "
183799|NCT00249119|"     The purpose of the study is to evaluate the effectiveness and safety of different doses of     risperidone (an antipsychotic medication) compared with a fixed 10-mg dose of a standard     antipsychotic, haloperidol, in patients with chronic schizophrenia.   "
183800|NCT00249132|"     The purpose of the study is to evaluate the effectiveness and safety of different doses of     risperidone (an antipsychotic medication) compared with placebo and with a fixed 20 mg/day     dose of a standard antipsychotic, haloperidol, in patients with chronic schizophrenia.   "
183801|NCT00249145|"     The purpose of the study is to compare the safety and efficacy of risperidone (an     antipsychotic medication) to that of placebo in the treatment of behavioral disturbances     associated with dementia.   "
183802|NCT00249158|"     The purpose of the study is to compare the effectiveness of an oral formulation of     risperidone (an antipsychotic medication) to that of placebo for treating behavioral and     psychological signs and symptoms in dementia (BPSSD), specifically aggression, delusions, and     hallucinations, in patients with dementia.   "
183803|NCT00249171|"     The purpose of the study is to show that risperidone (an antipsychotic medication) combined     with lorazepam (an anti-anxiety medication) is more effective than conventional therapy     administered by intramuscular injection for emergency treatment of patients with     schizophrenia.   "
183804|NCT00249197|"     The purpose of this study is to compare the safety and effectiveness of levofloxacin (an     antibiotic) with ticarcillin/clavulanate alone or followed by amoxicillin/clavulanate in the     treatment of complicated skin infections.   "
183805|NCT00249210|"     The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an     antibiotic, compared with amoxicillin/clavulanate potassium in the treatment of adults with     rapid onset of severe inflammation/infection of the sinuses.   "
183806|NCT00249223|"     The primary purpose of the study is to show that treatment with an injectable formulation of     risperidone is not less effective than and has a similar safety profile to risperidone     tablets in patients with chronic schizophrenia.   "
183807|NCT00249236|"     The purpose of the study is to assess the effectiveness and safety of risperidone (an     antipsychotic medication) versus placebo in treating mania during 3 weeks of treatment in     patients with Bipolar I Disorder who suffer from manic or mixed episodes.   "
183808|NCT00249249|"     The purpose of this study is to compare the efficacy of pitavastatin with that of     atorvastatin.   "
183809|NCT00249262|"     To evaluate objective response rate and duration of response to weekly Taxoprexin®.      To evaluate the safety profile of weekly Taxoprexin® in this patient population.      To evaluate overall survival in the same patient population. To evaluate time to disease     progression, and the time to treatment failure in patients with metastatic malignant melanoma     being treated with weekly Taxoprexin® Injection.   "
183810|NCT00249275|"     The aim of this study was to compare the effectiveness of two interventions, namely providing     free spectacles or only a prescription to students with insufficiently corrected or     uncorrected significant refractive errors.   "
183811|NCT00249288|"     This study aims to examine factors potentially contributing to differences in blood folate,     homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low     folate is associated with negative symptoms, and to examine the efficacy of folate     supplementation for reducing negative symptoms.   "
183812|NCT00249301|"     The purpose of this study is to determine (1) The side effects or toxicities of MLN8054;(2)     The highest dose where side effects or toxicities are not too severe; (3) How MLN8054 is     absorbed into the general blood circulation and eliminated from the body; and (4) The levels     of MLN8054 in the blood that are needed to inhibit Aurora A kinase.   "
183813|NCT00249314|"     The purpose of this study is to directly compare the body composition, body fat distribution,     and morphological and functional features of adipose tissue and skeletal muscle between South     Asians and European Caucasians.   "
183814|NCT00249327|"     This is an evaluation of the effect that an online live action, dramatic vignette about four     gay men, two HIV positive and two HIV negative, struggling with the responsibility for safer     sex has on the sexual behavior and HIV testing intentions of the gay/bisexual men who watch     the vignette and participate in the evaluation study. The primary hypothesis is that men will     be more likely to: 1)express the intent to have an HIV test and 2) to express the intent to     inform their sex partners of their HIV status after watching the vignette. The secondary     hypothesis is that men will be more likely to follow through on these intentions in the three     months following the intervention than they were in the three months before viewing the     vignette. This is a one group pre-posttest intervention in which each man serves as his own     control.   "
183815|NCT00249340|"     The purpose of this study is to compare the effectiveness of Weight Watchers, brief     behavioral treatment, and a combination treatment. We hypothesize that a combination     treatment will achieve greater weight losses than Weight Watchers alone.   "
183816|NCT00249353|"     The purpose of this study is to evaluate the safety and effectiveness of CONCERTA®     (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) versus placebo for     the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents..   "
183817|NCT00249366|"     The purpose of this study is to test how tolerable and effective lorazepam is when used to     treat alcohol withdrawal in hospital patients at risk for alcohol withdrawal.   "
183819|NCT00249392|"     Environmental and genetic factors may play a role in the progression of ocular diseases     (cataract, retinopathy, age-related macular degeneration, glaucoma, retinal detachment,     ocular tumor, etc.). The goal of this project is to establish a series of case-control     studies to evaluate risk factors of ocular diseases in China.   "
183820|NCT00249405|"     This study is being done to determine if citalopram is safe and effective in the treatment of     alcohol dependence. A second purpose is to evaluate whether alcohol dependent individuals who     differ in a specific genetic marker respond differently to citalopram.      Citalopram is a drug approved by the U.S. Food and Drug Administration (FDA) for the     treatment of depression. It belongs to a category of medications called selective serotonin     re-uptake inhibitors or SSRIs. The U.S. FDA has not approved citalopram for the treatment of     alcohol dependence. Therefore, it is being used off-label in this study.   "
183821|NCT00249418|"     The purpose of this study is to train therapists to administer contingency management (CM).     This project will train up to 42 community-based treatment providers about the rationale for     and the specifics of administering CM. Initial training will occur in 2-day workshops,     followed by weekly supervision in delivery of CM with test cases. We expect that the majority     of therapists will achieve high levels of competence and adherence in administering CM     treatment within 3-5 test cases, as measured by ratings of audiotapes. To examine the     efficacy of CM, each therapist who achieves adherence and competence in delivering CM will     administer standard treatment alone or standard treatment plus CM to substance-abusing     outpatients. In the CM condition, patients will have the opportunity to win prizes for     submission of negative samples, and the treatment will be in effect for 12 weeks. In total,     up to 200 patients will be randomly assigned to one of the two conditions. A research     evaluator will conduct follow-up assessments, scheduled for 3, 6 and 9 months after treatment     initiation.   "
183822|NCT00249431|"     Pathological gamblers often are also dependent on alcohol and clinically depressed.     Sertraline (Zoloft) is currently used to treat depression, panic disorder, and     obsessive-compulsive disorder. The purpose of this trial is to determine the effectiveness of     sertraline used in combination with relapse prevention therapy in decreasing gambling     behavior and alcohol consumption in individuals with a diagnosis of pathological gambling and     alcohol abuse or dependence.   "
183823|NCT00249444|"     Many substance dependent individuals also suffer from depression. Past research suggests that     antidepressant medication is helpful in treating such individuals. This study will determine     the effectiveness of mirtazapine, an antidepressant medication, in treating cocaine dependent     individuals who also suffer from depression. This study includes free treatment for cocaine     dependence that includes medication and a behavioral intervention.   "
183824|NCT00249457|"     The purpose of this study is to determine whether long-term exposure to the Therapeutic     Workplace intervention could sustain drug abstinence over an extended period of time in     heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.   "
183835|NCT00249600|"     The purpose of this study is to evaluate the efficacy of prize contingency management (CM) in     enhancing attendance, reducing drug use, and improving health among clients attending two HIV     drop-in centers. Specifically, 172 clients are randomly assigned to one of two 6-month     treatment conditions: standard 12-step oriented group treatment, or CM group treatment. In     the CM group, clients earn the chance to win prizes for submitting clean urine specimens and     for complying with steps toward their treatment goals. Activities related to improving health     will be emphasized, such as attending medical appointments, recording daily medication     consumption, getting prescriptions filled, and attending medication adherence support groups.     Group attendance, drug use, medical problems, services received, and risky drug use and     sexual behaviors will be measured pre-treatment and at months 1, 3, 6, 9 and 12.   "
183825|NCT00249470|"     The primary purpose of the study is to determine if the central feature of the Therapeutic     Workplace, the abstinence reinforcement contingency, is critical to initiate cocaine     abstinence in injection drug using methadone patients who use cocaine consistently during     methadone treatment. All subjects initially will be invited to attend the Therapeutic     Workplace for an initial period, but abstinence will not be required to work during that     time. During this initial period, vouchers will be contingent only on workplace attendance     and performance on the training programs. Subjects (n=70) who attend the workplace     consistently during the first 4 weeks of treatment, but who continue to use cocaine will be     randomly assigned to a Work Only or an Abstinence Plus Work group. Subjects in the Work Only     group will continue to be able to work independent of their urinalysis results. However,     subjects in the Abstinence Plus Work group will be required to provide urine samples that     show evidence of recent cocaine abstinence. Subjects in both groups will be invited to stay     in the workplace for 6 months. We expect the subjects in the Abstinence and Work group will     achieve higher rates of abstinence than the subjects in the Work Only group. This result     would show that the abstinence reinforcement contingency (i.e., the requirement to provide     cocaine-free urine samples to work and earn vouchers) is important in the initiation of     abstinence in the study population.   "
183826|NCT00249483|"     Preliminary research has shown that venlafaxine, a medication currently used for treating     depression, may also discourage cocaine use in depressed individuals. This study will     evaluate the effectiveness of venlafaxine in reducing cocaine use and alleviating depression     in individuals addicted to cocaine.   "
183827|NCT00249496|"     This application is a competing continuation of a grant in which we developed and pilot     tested a computerized Therapeutic Workplace designed to train and employ adults as data entry     operators. A randomized trial is planned over 5 years to investigate the Therapeutic     Workplace business as a maintenance intervention to sustain long-term abstinence and     employment. Welfare recipients in methadone treatment, actively using cocaine, and at risk     for contracting or spreading HIV infection will participate in an initial Therapeutic     Workplace training phase. Participants who become abstinent and skilled will be randomly     assigned to an Abstinence & Employment, or an Employment Only group. Participants in the     Abstinence & Employment group will be employed for one year in a Therapeutic Workplace     business and will have to provide drug-free urine samples to work and earn salary. Employment     Only participants will be offered employment for one year, but these participants will not     have to provide drug-free urine samples to work. This study will provide a rigorous     evaluation of the efficacy of the Therapeutic Workplace business as a long-term treatment of     cocaine addiction and unemployment; determine the benefits of requiring daily evidence of     abstinence to work; and provide information on the extent to which a Therapeutic Workplace     business can become self-sustaining. This research could provide firm scientific foundation     for the dissemination of Therapeutic Workplace businesses in the long-term treatment of     cocaine addiction and unemployment. The main hypothesis being tested is that cocaine     abstinence will be reliably maintained during the yearlong intervention evaluation period     only in the group exposed to the explicit abstinence maintenance intervention. We expect that     cocaine abstinence in the Abstinence and Employment group will be significantly greater than     cocaine abstinence in the Employment Only group.   "
183828|NCT00249509|"     Recent research has identified the following withdrawal symptoms to be associated with     abruptly stopping marijuana use: anxiety, irritability, bodily aches and pains, and     difficulty sleeping. These symptoms resemble those of both depression and nicotine     withdrawal, suggesting that a similar treatment drug may be useful. This study will evaluate     the effectiveness of two antidepressant drugs, bupropion and nefazodone, in reducing     withdrawal symptoms in marijuana dependent individuals.   "
183829|NCT00249522|"     The purpose of this study is to compare voucher-based contingency management (CM) procedures     to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent     outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus     voucher CM for abstinence, defined by negative breath and urinalysis test results, or (c)     standard treatment plus prize CM for abstinence, defined by negative breath and urinalysis     test results. Urine and breath samples are collected 3x/week during Weeks 1-3, 2x/week during     Weeks 4-6 and 1x/week during Weeks 7-12. Follow-up interviews are conducted 1,3,6 and 9     months following intake during which substance use and psychosocial functioning are assessed.   "
183830|NCT00249535|"     The purpose of this study is to compare voucher-based contingency management (CM) procedures     to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent     outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus     usual magnitude prize CM, (c) standard treatment plus higher magnitude prize CM, or (d)     standard treatment plus voucher CM. Urine and breath samples are collected 2-3x/week for 14     weeks. Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which     substance use and psychosocial functioning are assessed.   "
183831|NCT00249548|"     The purpose of this study is to evaluate the effectiveness of a lower-cost contingency     management (CM) procedure in Hispanic substance abusing outpatients. Thirty individuals     meeting DSM-IV criteria for substance dependence receive one of two conditions: (a) standard     treatment, or (b) standard treatment plus prize CM. Using a cross-over design, CM is     implemented in a community-based outpatient clinic and compared with non-CM in the same     clinic. The participating clinic is randomly assigned to receive either the CM or non-CM     phase first; 15 weeks after the final participant in one phase is enrolled, a one-week     washout period occurs, followed by a switch to the other phase. Patients initiating     outpatient treatment during the non-CM phase receive standard treatment and submit urine and     breath samples 2/week during Weeks 1-6 and 1/week during Weeks 7-12. Patients initiating     treatment during the CM phase also receive standard treatment and the same breath and urine     monitoring. In addition, they earn the opportunity to win prizes for coming to treatment and     for submitting negative breath and urine samples. Follow-up interviews are conducted at 1,3,6     and 9 months following intake during which substance use and psychosocial functioning are     assessed.   "
183832|NCT00249561|"     The major aim of the project is to document and evaluate two treatments for female offenders     with substance abuse problems (TC and cognitive behavioral), simultaneously studying the     process of treatment, and relating treatment process to treatment outcome.   "
183833|NCT00249574|"     The purpose of this study is to see whether street-recruited heroin users can be successfully     treated for hepatitis C after stabilizing them on buprenorphine.   "
183834|NCT00249587|"     The purpose of this study is to develop and pilot test a combined behavioral and     pharmacological intervention designed to decrease pain, functional interference, and drug     abuse while increasing medication adherence.   "
183836|NCT00249613|"     The purpose of this study is to determine whether substance abuse treatment designed     specifically for drug-dependent women offenders provides better outcomes than standard drug     court treatment (mixed-gender programs).   "
186085|NCT00282789|"     We investigated whether treatment of central sleep apnea-hypopnea with bilevel positive     airway pressure (BiPAP) in patients with idiopathic dilated cardiomyopathy (IDCM) would     improve LV function.   "
183837|NCT00249626|"     The purpose of this study is to train therapists to administer contingency management (CM).     This project will train up to 42 community-based treatment providers about the rationale for     and the specifics of administering CM. Initial training will occur in 2-day workshops,     followed by weekly supervision in delivery of CM with test cases. We expect that the majority     of therapists will achieve high levels of competence and adherence in administering CM     treatment within 3-5 test cases, as measured by ratings of audiotapes. To examine the     efficacy of CM, each therapist who achieves adherence and competence in delivering CM will     administer standard treatment alone or standard treatment plus CM to substance-abusing     outpatients. In the CM condition, patients will have the opportunity to win prizes for     submission of negative samples, and the treatment will be in effect for 12 weeks. In total,     up to 200 patients will be randomly assigned to one of the two conditions. A research     evaluator will conduct follow-up assessments, scheduled for 3, 6 and 9 months after treatment     initiation.   "
183838|NCT00249639|"     The purpose of this study is to evaluate the effectiveness of a low-cost contingency     management procedure as compared to standard treatment. Using a cross-over design, CM is     implemented at different community-based clinics and compared with non-CM in the same     facilities. Research staff collects information regarding patients' demographic     characteristics, attendance, and outcomes at the clinics. During Phase A (non-CM), standard     clinical practice is in place. During Phase B (CM), all patients have the chance to win     prizes by coming to treatment. Each participating clinic is randomly assigned to receive     either the A or B phase first; each phase is in effect for 16 weeks.   "
183839|NCT00249652|"     The purpose of this study is to test a novel distance-based (telephone) intervention to help     transplant candidates with current or recent substance abuse to stay clean and sober both     prior and following transplant surgery.   "
183840|NCT00249678|"     The purpose of this study is...to assess whether placing a substance abuse intervention for     HIV+ methamphetamine users within an HIV medical care setting improves rates of follow-up on     referral to treatment by primary care physicians; reduces drug use and sexual risk behaviors     more than treatment-as-usual; and increases rates of adherence to HIV medication regimens.   "
183841|NCT00249691|"     Although a great amount of research has been conducted to resolve cocaine dependence, an     effective treatment has yet to be discovered. Topiramate is a drug that was found to be     useful in treating alcohol dependence. The purpose of this study is to determine the     effectiveness of topiramate in treating cocaine dependent individuals.   "
183843|NCT00249717|"     The purpose of this study is to evaluate the efficacy of prize-based contingency management     (CM) when administered exclusively in groups. Substance dependent patients (N=360) at     community-based treatment programs are randomly assigned to one of two conditions: (a)     standard, non-CM treatment or (b) standard treatment plus prize CM delivered in groups. In     the CM condition, patients earn the opportunity to win prizes for attending groups and     submitting drug-free biological specimens. Substance use and psychosocial problems are     measured at intake, month 1, month 3 (post treatment), and at 6-, 9-, and 12-month follow-up     evaluations. We also assess patient characteristics that may be associated with improved     outcomes within and across conditions.   "
183844|NCT00249730|"     To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile     dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at     the end of double blind treatment, comparing the group titrated to 100mg vs. the group     maintained on 50mg.   "
183845|NCT00249743|"     Falls are a public health problem of significant social and economic significance. No primary     intervention devices have been shown to be effective in reducing falls and associated     injuries. The objective of this study was to determine whether the new wireless FallSaver     device reduces falls and fall-related injuries in elderly skilled nursing facility (SNF)     residents. A randomized, prospective, open-label, cross-over study was conducted over a     six-month period. The FallSaver device reduced the frequency of falls by 50% and fall-related     injuries by 82% in 43 elderly at-risk SNF residents studied over 4,222 patient-days. The     device and associated patch enclosure was well tolerated and devoid of serious problems.     Significant cost savings and fewer reductions in quality of life are possible if fall-related     injuries can be reduced.   "
183846|NCT00249756|"     The purpose of this study is to examine the transition of offenders with both mental illness     and chemical abuse (MICA) disorders from prison to the community, where continued treatment     is generally considered necessary to sustain gains made by prison treatment, and to achieve     successful outcomes. The project will determine the effectiveness of a modified therapeutic     community (Re-Entry MTC) approach as compared to the case management and parole supervision     currently provided. The study will also assess the relative impact on treatment outcomes of     the type of treatment received while in prison and of the progress achieved in re-entry     treatment.   "
183847|NCT00249769|"     This study will determine whether it is safe and effective to administer Japanese     encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If     it is found to be safe, it will pave the way for use in routine vaccination programs. The     hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles     vaccine at the same time are protected against these diseases at the same level as those who     receive the vaccines at different intervals.   "
183848|NCT00249782|"     The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared     to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for     the treatment of rosacea.      ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United     States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12     years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An     investigational use is one that is not approved by the FDA.      Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed     at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline     and Week, 2, 4 and 12.   "
186086|NCT00282802|"     The purpose of this study is to examine the role of genetic and environmental factors in the     cause of Parkinson's disease.   "
183849|NCT00249795|"     The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the     risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and     death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular     events.   "
183850|NCT00249808|"     Phase IIIb/IV , open-label, multi-centre study in patients receiving efalizumab 1mg/kg/week     for 12 weeks.      At anytime during the first 12 weeks, non-responding or worsening patients will discontinue     efalizumab and enter a 12-week treatment period with other approved antipsoriasis therapies.      Objectives:        -  To establish safe psoriasis control of moderate to severe chronic plaque psoriasis with          efalizumab in patients who have failed to respond to, or who have a contraindication to,          or are intolerant of other systemic therapies including cyclosporine, methotrexate and          PUVA.        -  To evaluate the management of psoriasis events namely rebound and exacerbation, in          patients while on Efalizumab or subsequent to its discontinuation   "
183851|NCT00249821|"     Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1     group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of     Saizen® during 1 year to 1 group receiving 0.035 mg/kg/day (0.24 mg/kg/week) of Saizen®     during 1 year after an initial 3-year treatment of recombinant human growth hormone (r-hGH)     therapy with 0.057 mg/kg/day in both groups.   "
183852|NCT00249834|"     CONSORT = Clinical validation of the ART treatment guidelines, which determine the optimal     dose of r hFSH based on subject baseline characteristics/predictors of ovarian response.      Phase IIIb/IV, open-label, multi-centre, multi-regional study. Subject will first be treated     with a GnRH agonist according to centre's standard practice (no depot formulation will be     allowed). Down-regulation is to be confirmed by E2 levels and/or US scan depending on     centre's standard practice. Subject will then start r-hFSH treatment (Gonal-f® Prefilled Pen)     at a pre-defined, fixed dose according to the provided ART treatment guidelines. Dose     adjustment will be allowed strictly in case of risk of OHSS. Once follicular development is     adequate (ie. at least 1 follicle ≥ 18mm and 2 follicles ≥ 16mm), a single injection of 250     mcg of r-hCG (Ovid[t]rel [le]®) will be administered.      Ovum Pick Up (OPU), in vitro fertilisation (IVF) and embryo transfer (ET) will be performed     as per centre's standard practice.      A post-treatment safety visit will be performed for all subjects on days 15-20 post-hCG.   "
183853|NCT00249847|"     The purpose of this study is to determine in a preliminary manner whether successful therapy     of hot flashes can be associated with changes in the serotonin transporter in the brain. The     serotonin transporter is important in delivering serotonin into certain portions of the     brains (serotonin is a chemical that is important in the control of body temperature, mood,     sleep, and other functions).   "
183854|NCT00249860|"     The main objective of this study is to establish interferon-beta-1a as the treatment of     choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or     combination therapy.      This will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo     to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment     during an open-label extension phase. The duration of the trial will be 48 weeks, with a     double-blind period of 12 weeks.      The study will recruit 257 eligible subjects of either sex. It will be conducted by     approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and     Singapore).   "
183855|NCT00249873|"     The purpose of this study is to determine if the combination of clopidogrel 75mg once daily     (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily     recommended dose) for preventing vascular events such as stroke and heart attack during     approximately three years of follow-up in patients with atrial fibrillation associated with     at least one major risk factor of vascular event such as elderly, blood pressure increase,     history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study     will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant     therapy.   "
183856|NCT00249886|"     The purpose of the study is to evaluate whether it is advantageous for adolescents who have     recovered from depression after a 6 to 12 week course of antidepressant treatment to stay on     the treatment a further 6 months or is it just as helpful to stop the medication after     recovery.      The hypothesis is that adolescents with major depression who recover from the 6 to 12 week     trial of citalopram will be less likely to have a recurrence of depression over a 6 month     period if continued on the citalopram as compared to those who discontinue the medication.   "
183857|NCT00249899|"     The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or     with additional statin therapy on cholesterol levels in treating patients with elevated     cholesterol.   "
183858|NCT00249912|"     The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or     with rosuvastatin on cholesterol levels in treating patients with elevated cholesterol.   "
183859|NCT00249925|"     The specific aims of the study are to: 1) test the effectiveness of a home-bases intervention     to improve home safety, fall efficacy and functional performance; 2) determine if the use of     environmental strategies results in occurrence of less negative health events (falls and     depression); 3) compare types of environmental strategies accepted and used under different     treatment conditions; and 4) evaluate the cost-effectiveness of the intervention program.   "
183860|NCT00249938|"     The purpose of this study is to see if combination therapy with a statin medication and two     additional agents that work differently than statin medications can further lower the     so-called bad cholesterol. One therapy is a prescription drug approved by the Food and Drug     Administration to treat high cholesterol (Welchol). The other therapy is Minute Maid Heart     Wise orange juice. This study juice is available in supermarkets and contains plant sterols     that have been shown to lower cholesterol.   "
183861|NCT00249951|"     Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to     birth weight and gestation age. Very low birth weight infants have the highest risk index,     with ~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. We,     the researchers at the University of Cologne, and others found significantly decreased     urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we     hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's     solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the     incidence of nephrocalcinosis.   "
183862|NCT00249964|"     The purpose of this study is to determine the maximum tolerable dose of temozolomide in     combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor     response rate with this combination and to determine the duration of response.   "
183863|NCT00249977|"     1. To determine the safety and feasibility of administering Capecitabine with the          combination of Cisplatin and Irinotecan.        2. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the          combination of Cisplatin and Irinotecan.        3. To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin          therapy.   "
183864|NCT00249990|"     The purposes of this study are:      1.1 To determine the efficacy of liposomal 9-Nitro-20 (S)-Camptothecin (L9NC) administered by     aerosolization to patients with metastatic endometrial cancer.      1.2 To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive     days per week X 8 weeks, every 10 weeks.      1.3 To perform a pharmacology study of L9NC in the plasma and the lungs after aerosolization.     A specific protocol will be written for this part.   "
183865|NCT00250003|"     To investigate whether preventive home visits for healthy persons 75+, made by professional     health workers, can change the pattern of care utilization and if the quality of life can     improve. The hypothesis is that care utilisation will reduce, mortality decrease and quality     of life improve.   "
183866|NCT00250016|"     The purpose of this study is to determine the amount of Aerosolized Liposomal-Nitro-20     (S)-Camptothecin (L9NC) in a patients blood and tumor.   "
183867|NCT00250029|"     1.1 To collect pathological tumor specimens of patients with metastatic colorectal cancer in     a prospective fashion for correlative studies of response to an oxaliplatin based     chemotherapy regimen.      1.2 To determine a gene expression profile that predicts response to an oxaliplatin based     chemotherapy regimen in this cohort of patients.   "
183868|NCT00250042|"     1.0 OBJECTIVES 1.1 To test the activity of arsenic trioxide in combination with imatinib in     patients with CML with cytogenetic evidence of residual disease.      1.2 To determine the toxicity associated with this therapy.   "
183869|NCT00250055|"     In general, to determine the sensitivity of light transport to tissue from morphological     features of clinical significance.      Determine how specific structural features contribute to light scattering. Investigate light     scattering differences in tumorigenic and nontumorigenic cells.      Develop and implement quantitative and sensitive methods for measuring morphological     properties.      Clinical measurements.   "
183918|NCT00243841|"     The purpose of this study is to determine the maximum tolerated dose of limited fractions of     large dose radiation in an effort to achieve a biologically potent cancer therapy in selected     patients with primary hepatocellular carcinoma.   "
183870|NCT00250068|"     To determine the overall response rate to liposomal 9-Nitro-20 (S)-Camptothecin (L9NC)     administered by aerosolization in patients with non-small-cell lung cancer (any stage.      To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days     per week X 8 weeks, every 10 weeks.      To perform a pharmacology study of L9NC in the plasma, and the lungs after aerosolization. A     specific protocol will be written for this part.   "
183871|NCT00250081|"     Doctors use different treatments for people with Cerebral Palsy. Surgery is one option.     Botulinum toxin injections are another option; these are given directly into spastic muscles     to weaken them temporarily. Regular ongoing treatment (splinting, stretching and exercises)     is another option. The investigators want to find out if surgery works better than Botulinum     Toxin (Botox) injections or regular ongoing treatment (therapy), and if the effects of     Botulinum Toxin injections last for longer than six months.   "
183872|NCT00250094|"     1.1 To determine the regulation of topoisomerase I and II following alternating prolonged     exposure to topotecan and etoposide (VP-16)      1.2 To determine the time to progression and the objective response rate of this treatment in     patients with incurable ovarian cancer.   "
183873|NCT00250120|"     To determine the overall response rate to liposomal 9-Nitro-20 (S)-Camptothecin (L9NC)     administered by aerosolization in patients with non-small-cell lung cancer (any stage).      To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days     per week X 8 weeks, every 10 weeks.      To perform a pharmacology study of L9NC in the plasma, and the lungs after aerosolization. A     specific protocol will be written for this part.   "
183874|NCT00250133|"     Selective decontamination of the digestive tract (SDD) is a prophylactic measure aimed at     reducing Gram negative flora in the gut with an aim to reduce nosocomial infections such as     ventilator-associated pneumonia. A recent large randomized trial in the Netherlands showed     that SDD use was associated with reduced mortality in the ICU. Theoretically, SDD may select     for Gram positive organisms such as MRSA or VRE. This was not observed in the Dutch study,     but the rates of MRSA and VRE are very low in hospitals in the Netherlands. Fears of     selection of MRSA and VRE have limited application of SDD in the United States.      In this pilot study, 40 patients in the transplant intensive care unit (where SDD has been     used intermittently for at least 10 years), will be randomized to SDD or no SDD. These     patients will be known to be VRE positive at baseline. The effects of SDD on the density of     VRE in the stool on day 7 compared to pre-SDD will be the primary endpoint. Secondary     endpoints will be detection of MRSA and colistin resistant Pseudomonas in the stool.   "
183875|NCT00250146|"     The purpose of this study is to evaluate the toxicity of minute doses of gluten in the     treatment of celiac disease, a disorder characterized by permanent intolerance to dietary     gluten.   "
183889|NCT00243464|"     The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of     calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment     of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is     patients with clear or minimal disease after 8 weeks treatment.      Further the occurrence of relapse and rebound after end of treatment in patients with clear     or minimal disease will be investigated.   "
183890|NCT00243477|"     The purpose of this study is to determine the effect of an antidepressive medication     (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year     post-operative morbidity and mortality after coronary artery bypass grafting   "
183891|NCT00243490|"     Primary Objective:        -  The primary objective is to evaluate the efficacy of photodynamic therapy in the          treatment of malignant intracranial tumors.      Secondary Objective:        -  The secondary objective is to evaluate the safety of photodynamic therapy in the          treatment of malignant intracranial tumors.   "
183876|NCT00250159|"     This study will evaluate and gather information in patients with genetic causes of too much     androgen (male-like hormone) in order to better understand the effects of too much androgen     and describe problems associated with it. Too much androgen in childhood, if untreated,     results in rapid growth and early puberty with early cessation of growth and short stature in     adulthood. Too much androgen in adulthood may result in infertility, and women may have     excess facial hair, acne and a more male-like appearance. Excess androgen may also affect     mood and behavior and possibly the secretion of other hormones, such as insulin. Two genetic     diseases that result in early childhood androgen excess are congenital adrenal hyperplasia     (CAH) and familial male-limited precocious puberty (FMPP).      Patients with known or suspected CAH due to 21-hydroxylase deficiency, 11- hydroxylase     deficiency, or 3-beta-hydroxysteroid dehydrogenase deficiency and males with known or     suspected FMPP may be eligible for this study. Patients with both classic and non-classic CAH     are eligible, and patients with androgen excess of unknown cause may be eligible.      Participants undergo the following procedures:        -  Medical history and physical examination.        -  Fasting blood tests for analysis of hormones, blood chemistries including blood sugar          and cardiovascular risk factors such as lipids.        -  Oral glucose tolerance test for patients with elevated insulin levels. For this test, a          catheter (plastic tube) is placed in a vein in the patient's arm. The patient drinks a          sugar-containing fluid and blood samples are collected through the catheter at intervals          starting with drinking the solution, and then 30, 60 and 120 minutes after drinking the          solution.        -  24-hour urine collection to measure hormone levels in the urine.        -  DNA testing for patients with 21-hydroxylase deficiency to help identify the type of          genetic mutation responsible for the disease.        -  X-ray of the left hand to measure bone age in growing children. The x-ray is used to          determine how far into puberty the child is and how much growth potential is left in the          bones.        -  A pelvic ultrasound in females and testicular ultrasound in males to evaluate the size          and development of the gonads (ovaries in females and testes in males).        -  Cognitive and psychological tests, including an IQ test and evaluation of memory,          achievement and behavior.        -  Other tests and evaluations based on medical need.      The schedule for these procedures varies. In a part of the study involving only patients with     CAH, growing children are evaluated twice (once in childhood and once after reaching adult     height), and adults are evaluated once. In another part of the study involving patients with     CAH and FMPP, growing children are seen twice a year, and adults and children who have     reached adult height may be seen annually. Additional visits may be scheduled if medically     indicated. In this part of the study, females are asked to keep a record of their periods     after their first menstrual cycle.   "
183877|NCT00243308|"     Males and females aged 18-80 years who present with ACS (unstable angina and non ST-elevation     MI) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours     before admission and greater than 0.05 mV of presumed new ST-segment depression in at least 2     contiguous ECG leads OR, angina and per confirmatory angiogram, has been scheduled for     percutaneous coronary angioplasty. The primary objective of this study is to evaluate the     safety of Serp-1 injection when administered in 3 daily doses to patients undergoing     conventional therapy for Acute Coronary Syndrome (ACS) requiring early intervention.   "
183878|NCT00243321|"     The principal objective of this study is to demonstrate that patients can safely receive     combined High Dose Rate brachytherapy and Intensity-Modulated Radiation Therapy without     experiencing a treatment limiting toxicity.   "
183919|NCT00250172|"     The purpose of this study is to measure a particular protein in the brain called the     phosphodiesterase by using the imaging techniques of positron emission tomography (PET) and     magnetic resonance imaging (MRI).   "
183879|NCT00243334|"     The purpose of this study is to evaluate the impact of integrating ambulatory computerized     physician order entry (ACPOE) and advanced clinical decision support systems (CDSS) on safety     and quality domains in the ambulatory setting, including: a) medication monitoring, b)     preventive care and chronic disease management, and c) test result follow-up. In addition we     will evaluate the impact on organizational efficiency, physician workflow and satisfaction,     and perform a cost-benefit analysis. We hypothesize that the value of ACPOE integrated with     advanced CSDSS lies in improved medication safety and guideline compliance, but also improved     efficiencies for the provider and the health-care system.   "
183880|NCT00243347|"     This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC.     The safety and tolerability of AZD2171 will also be studied.   "
183881|NCT00243360|"     The purpose of this study was to determine if a multi-faceted intervention to implement     diagnostic and therapeutic algorithms for management of suspected urinary infection in     nursing home residents could reduce antibiotic prescribing for urinary indications in this     population.   "
183882|NCT00243373|"     This study will investigate the impact of barcode technology on medication errors made by     nursing. In addition, it will measure the impact of this technology on nursing workflow and     satisfaction.   "
183883|NCT00243386|"     The primary purpose of this randomized, two-arm parallel clinical study in 66 previously     treated patients with severe or moderately severe hemophilia A is to compare the rate of     bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose     determined by the investigator) with that of alternate prophylaxis (20-80 IU/kg every 72 + 6     hours; actual dose determined by Baxter utilizing an algorithm and the patient's     pharmacokinetic data). The rates of bleeding episodes for the on-demand regimen and the     prophylaxis regimens will also be compared for the cross-over portion of the study. Enrolled     patients will be treated originally on demand for a period of 6 months and then they will be     randomized into one of the prophylaxis arms. Prophylactic treatment will last for a period of     12 months +/- 2 weeks.   "
183884|NCT00243399|"     The purpose of this study is to evaluate the safety of the drug oxandrolone (a type of     androgen steroid) in patients with Fanconi anemia (FA), and to determine if this drug can     help in the treatment of bone marrow failure in these patients. Androgen steroids are male     hormones that can stimulate the production of red blood cells (the cells which carry oxygen     in the blood) and platelets (cells that help blood clot).   "
183885|NCT00243412|"     This was a Phase II, randomized, double-blind, multicenter study designed to evaluate the     safety and efficacy of rituximab, administered at two different regimens for 2 years, in     patients with moderate to severe active rheumatoid arthritis (RA) receiving stable doses of     methotrexate (MTX).   "
183886|NCT00243425|"     The investigators propose to answer the following research question: Does a multifaceted,     culturally tailored intervention that focuses on the specific concerns and preferences of     African American patients with depression and their primary care providers improve the     processes and outcomes of care for African Americans to a greater degree than a standard     state-of-the art depression intervention?      This study will determine whether two new educational programs can improve the care for     depression in African Americans. These programs may include visits with a depression case     manager and access to educational materials, such as a videotape, a calendar, pamphlets, and     books. One program is a standard quality improvement program for depression that has been     shown to be effective in most patients. The other program is similar, but has materials that     focus more on the patient’s specific culture, beliefs, values, and preferences.   "
183887|NCT00243438|"     Prospective Internet-Registry, Postmarketing-Surveillance, Registration and Follow-up of     patients after Multi-Link VISION™ - Stent Implantation   "
183888|NCT00243451|"     Our central hypothesis is that the early metabolic lesions of MCI can be reliably detected in     individual subjects by objective analysis of [18]F-fluorodeoxyglucose (FDG) positron-emission     tomography (PET) brain images, earlier and more accurately than by subjective clinician     rating.   "
183892|NCT00243503|"     The current study is to evaluate: Overall response rate for the combination of trastuzumab     and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and     tolerability of the combination; measure duration of tumor control and survival; assess     patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and     safety.   "
183893|NCT00243516|"     The purpose of this study is to evaluate if the implementation of quantitative pretest     probability assessment will significantly reduce the unnecessary use of the intra-emergency     department chest pain center. Specifically, the study will examine whether the PREtest     Consult acute coronary syndrome (ACS) pretest probability assessment system can significantly     reduce the use of chest pain unit evaluation in very low risk emergency department (ED)     patients, can safely discharge patients with a pretest probability ≤ 2.0%, can reduce     unnecessary procedures and lower hospital costs and will examine patient satisfaction of     patients with whom pretest probability assessment was used compared to those with whom it was     not used.      The researchers hypothesize that patients in the control group of the study will have     statistically significant reductions in mean time spent in the emergency department, mean     charges billed to the patient or their insurance carrier, hospital length of stay, mean     number of procedures or tests performed without a statistically significant change in patient     satisfaction or adverse outcome.   "
183894|NCT00243529|"     Dendritic cells (DCs)are the most potent antigen-presenting cells of the immune system, as     such they are able to direct the immune system specifically against cancer cells. Currently     DCs are used in clinical vaccination studies and immunological and clinical responses have     been observed. For inducing anti-tumor immunity, the DCs have to be loaded with tumor antigen     (i.e. molecular structures that are presented by the tumor, that are recognized by the immune     system). Currently most studies use tumor peptides (small protein fragments) for this     purpose. This approach has several disadvantages: only patients with a certain HLA-type can     be treated and the immune response that is induced by the vaccine is limited to the used     peptides. These disadvantages do not exist when the DCs present antigen which is endogenously     processed, for example after RNA transfection. For this reason we investigate the     immunogenicity of DCs that are pulsed with peptides or transfected with mRNA encoding     melanoma associated antigens in stage III and IV melanoma patients.   "
183895|NCT00243542|"     The purpose of this study is to gather more information about the safety of ACZONE Gel, 5% in     treating subjects with acne who have certain blood disorders.      ACZONE Gel, 5% is a prescription skin use (topical) medicine used to help treat acne in     people 12 years and older. ACZONE Gel, 5% has been studied in approximately 4000 people and     was shown to reduce the number of pimples and improve acne.      The active drug ingredient in ACZONE Gel, 5% is dapsone. People with blood disorders called     G6PD deficiency, methemoglobin reductase deficiency, and hemoglobin M have a higher     chance of side effects with dapsone.      G6PD is short for glucose-6-phosphate dehydrogenase. It is an enzyme found in red blood     cells, which carry oxygen to all parts of the body. G6PD helps the red blood cells to     function normally. Some people have less G6PD in their red blood cells than the average     person. This is called G6PD deficiency.      Two treatments - ACZONE Gel, 5% and placebo - will be studied for comparison.   "
183896|NCT00243555|"     The purpose of this study is to develop a tool to better predict clinical allergy to peanut,     so that those who are skin test positive but non allergic will not have to unnecessarily     avoid peanut, and those with true allergy can be diagnosed, possibly without oral ingestion     challenge, and treated appropriately   "
183897|NCT00243568|"     This is an international study of vicriviroc in 500 adult HIV-infected subjects who are     failing standard antiretroviral therapy (ART). HIV must be of a certain type known as     R5/X4-mixed tropic. Subjects allowed into the trial will be randomly assigned to treatment     with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to other     antiretrovirals (selected by the investigator to be optimal for the specific subject)     containing at least 3 drugs, including a protease inhibitor (PI) boosted with at least 100 mg     ritonavir QD. Subjects will be continued for up to 48 weeks of dosing.   "
183898|NCT00243581|"     The objective of this study is to evaluate the effect of the Ornish Program on cardiovascular     disease as measured by the IMT of the common carotid artery, and to compare this effect to     outcomes from patients participating in traditional cardiac rehabilitation.   "
183899|NCT00243594|"     Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As     such they are currently used in clinical vaccination protocols in cancer patients, and both     immunological and clinical responses have been observed. For these therapies accurate     delivery to target organs is essential. Correct delivery and subsequent migration of     vaccinated DCs to regional lymph nodes is of paramount importance for effective stimulation     of the immune system. Currently it is not known what the best route of administration is for     DC vaccines.      Using magnetically labeled DCs, we investigate the potential of MRI cell tracking to monitor     DC therapy. This is investigated in stage III/IV melanoma patients in whom a regional lymph     node dissection is scheduled. Autologous monocyte-derived DCs are labeled with the clinically     approved superparamagnetic iron oxide (SPIO) formulation Endorem and 111In-oxine and injected     either in the skin or directly in lymph nodes under ultrasound guidance. Two days after     vaccination patients are monitored with scintigraphy and MR imaging. Lymph nodes are then     resected. Subsequently patients receive 3 more vaccination with DCs. During and after therapy     immune responses against the used melanoma peptides are monitored.   "
183900|NCT00243607|"     Breast cancer survivors often suffer from climacteric symptoms caused by treatment or     diagnosis of their disease.      Hormone replacement therapy is contraindicated and other pharmacological options may also     include the risk of stimulating hormone receptors. Hydrotherapy following the guidelines of     naturopathy by S. Kneipp is a non-pharmacological treatment option which may influence     climacteric symptoms by affecting the regulation of body temperature. In this study, the     regular self application of hydrotherapy after initial training by a professional will be     evaluated for its efficacy, practicability, and compatibility.   "
183901|NCT00243620|"     Current treatment modalities for chronic leg ulcers are time consuming, expensive, and only     moderately successful. Recent data suggest that creating a sub-atmospheric pressure by Vacuum     Assisted Closure (V.A.C.®) therapy supports the wound healing process. Here, we studied the     efficacy of V.A.C.® in the treatment of chronic leg ulcers prospectively.   "
183902|NCT00243633|"     The conventional sonography is frequently used to detect incidental focal liver lesions     because of its availability, innocuity and low cost. Nevertheless, sensibility and     specificity of conventional sonography does not exceed 70% for tumoral affections.     Consequently the interest of this practice must be reconsidered by studying its ratio     cost/diagnosis contribution.      These limitations of conventional sonography have led to the use of other imaging modalities     and invasive or costly procedures such as computed tomography (CT), magnetic resonance     imaging (MRI) or biopsy. The availability of real-time contrast-enhanced ultrasound imaging     (CEUS) has changed the strategy in the characterization of focal liver lesions, on healthy or     cirrhotic liver in a neoplastic context or not, without inconvenience for the patient.      The aim of the present study is to evaluate the place of CEUS in term of diagnostic relevance     and catch of load cost, in the characterization of focal liver lesions detected but not     characterized by CT or conventional sonography.   "
183903|NCT00243646|"     Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of     pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in     hormonally-manipulated patients.   "
183904|NCT00243659|"     This study will examine the efficacy and safety of ReFacto AF in patients with severe and     moderately severe hemophilia A undergoing elective major surgery when administered by either     bolus injections (BI) or continuous infusion (CI).   "
183920|NCT00250185|"     Many studies have shown that if the human body is stressed by a lack of blood flow for a     short period of time, the body develops defenses to make the body more resistant to a future     stress from lack of blood flow. This natural defense system is called preconditioning.     Finding medications that have a preconditioning effect to protect against damage from loss of     blood flow would be of great help in the treatment of diseases such as heart attacks and     stroke that occur because of blockages of blood flow.      Predicting future heart attacks or strokes is very difficult and makes it difficult to study     medications that could have a preconditioning effect. However, it has recently been     recognized that we can mimic the preconditioning effect in the human arm, by blocking blood     flow using a blood pressure cuff under pressure. Here, blowing up the cuff for 5 minutes and     then letting the pressure out for 5 minutes and repeating this process twice more (a way to     precondition the arm), has been shown to improve blood vessel function in response to a     longer period of blood pressure cuff inflation (20 minutes).      As nitrite, a naturally occurring blood substance, has biological effects suggesting that it     may mimic preconditioning. The main objective of this study is to assess whether nitrite is     equivalent to preconditioning in its capacity to protect the forearm blood flow in response     to a 20 minute blockage of blood flow by blood pressure cuff inflation of the forearm.      We hypothesize that in human subjects the ischemic preconditioning program works through     activation of the pool of nitrite in the blood stream. Moreover, we propose that nitrite     treatment will improve (1) blood vessel recovery (2) skeletal muscle blood flow and (3)     skeletal muscle mitochondrial function and (4) reduce the activation of inflammation in     response to the 20 minute stress of blood pressure cuff inflation.   "
183905|NCT00243672|"     Rupture of unstable atherosclerotic plaques is the underlying pathophysiologic mechanism of     acute coronary syndromes and thus also of perioperative myocardial ischemia. Lipid lowering     drugs such as statins and fibrates have been shown to improve the outcomes of patients with     atherosclerosis. This is not only mediated through their therapeutic actions on lipid     metabolism, but relies on a multitude of pleiotropic effects of these substances. One of the     most interesting of these effects is the stabilisation of atherosclerotic plaques.      To investigate these effects in a perioperative setting, patients scheduled for     thromboendarterectomy of the carotid artery will be recruited. They will be randomised to     receive either atorvastatin 10mg/d, gemfibrozil 1200mg/d or placebo for two weeks     preoperatively. Specimens of carotid plaques will be obtained intraoperatively. After     microscopic characterisation of plaques, DNA-microarray analyses will be done to gain     insights into the transcriptional regulation and expression profiles of various types of     atherosclerotic plaques under different pharmacological circumstances (stable or unstable     with statin/fibrate/placebo).   "
183906|NCT00243685|"     DiaTech is a private company performing patient specific cancer chemosensitivity testing for     patients and physicians. DiaTech Oncology is doing this clinical study to see if an     experimental new technology called the microculture kinetic (MiCK) assay will predict     treatment outcome and can help to direct the chemotherapy of cancer subjects. This study is     focused on subjects diagnosed with breast, ovarian, lung, and colon malignancies and     low-grade lymphomas.      Study Objectives:        -  To evaluate the ability of the MiCK assay to predict the outcome of chemotherapy of          cancer patients.        -  To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients.   "
183907|NCT00243698|"     Ultrasound is a well-established imaging modality for the evaluation of breast disease.      The investigators' objective is to characterise the properties of an intravascular     ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the     diagnostic value of the ultrasound examination in patients with different breast lesions.      The final purpose of this ultrasonography is to allow the early detection of tumors and to     improve the differentiation between benign and malignant lesions.      SonoVue® (sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable,     resistant to pressure, and specifically designed to be used as a contrast agent for     ultrasound imaging.      Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the     morphology of breast tumour vascularity.   "
183908|NCT00243711|"     The efficacy, safety and acceptability of an investigational lubricant eye drop in subjects     with dry eye will be evaluated in comparison with currently-available lubricant eye drops.   "
183909|NCT00243724|"     Determine if different levels of acid-suppression with esomeprazole for 6 months on chosen     histological markers of esophageal epithelial acid-related disease in patients with upper GI     symptoms.   "
183910|NCT00243737|"     Treatment of Plasmodium falciparum malaria in Africa is increasingly difficult. Resistance to     cheap efficient antimalarial drugs poses an increasing threat. The rapid emergence of     resistance to sulfadoxine - pyrimethamine, already seen in East Africa is growing and is     likely to have an striking impact on mortality in many other African regions where no obvious     alternatives are available. WHO recommends the use of drug combinations containing     artemisinin compounds, i.e., artemisinin-based combination therapies (ACT). Previous clinical     trials have shown that the combination of artesunate with mefloquine is highly effective and     well tolerated in the treatment of multidrug-resistant falciparum malaria, retaining the     benefit of rapidity of action while augmenting cure rates, and apparently slowing the     development of mefloquine resistance. Compliance with sequential combination regimen of     antimalarial drugs is notoriously poor. Therefore, in order to limit the development of     resistance to both drugs and ameliorate patients' compliance to antimalarial treatments, an     optimal simultaneous combination regimen of artesunate and mefloquine in a practical single     blister pack has been developed by Mepha Ltd. and successfully tested. The currently     available   "
183911|NCT00243750|"     Assessing the efficacy and tolerability of methotrexate 15mg sc in the first month of     treatment- if well tolerated methotrexate 20mg sc in the following 3 months in patients with     active anklyosing spondylitis   "
183912|NCT00243763|"     The primary objective of this study is to determine the maximum tolerated dose (MTD), dose     limiting toxicity (DLT), and safety profile of CHIR-258 when administered to subjects with     refractory or relapsed multiple myeloma (MM).   "
183913|NCT00243776|"     The study team will use small pieces of human hearts which are removed as part of a required     surgical procedure to study how calcium ions pass through the membrane of heart cells in     order to tell the heart cell how much force to contract with when the heart beats.     Investigators will also study the proteins and RNA of these pieces to determine how the     newborn heart cells control their force of contraction differently from adult heart cells.     Investigators hypothesize that infant hearts have different regulation of calcium entry than     adult hearts.   "
183914|NCT00243789|"     The purpose of this study is to see if male children with Duchenne muscular dystrophy (DMD)     have changes in strength when given the drug Pentoxifylline as a rescue treatment. A total of     64 subjects are expected to participate through all other centers of the Cooperative     International Neuromuscular Research Group (CINRG) worldwide.      The primary purpose of this study is to see whether the addition of pentoxifylline to a     steroid regimen is effective in treating deteriorating muscle strength by comparing the     muscle strength of PTX treated subjects and placebo treated subjects.   "
183915|NCT00243802|"     The purpose of the study is to look at the differences between people who have irregular     heart beats coming from the upper chamber of the heart (atrial fibrillation) compared to     those who do not have these irregular beats.   "
183916|NCT00243815|"     This research will determine whether prophylactic use of ibuprofen can prevent common side     effects of the copper intrauterine device (IUD) and prevent early removal of the device.   "
183917|NCT00243828|"     Total-face mask may improve the efficacy of NIV compared to conventional face mask in     patients with acute respiratory failure due to enhanced tolerance and the allowance of higher     airway pressure without massive leaks.MAIN OBJECTIVE: To assess, in acute respiratory failure     patients, whether the total-face mask reduce the intubation rate. METHODS: 300 patients     admitted in the ICU for acute respiratory failure needing continuous noninvasive mechanical     ventilation. The type of mask (total-face vs. conventional face mask) will be randomized.     Defined failure criteria and weaning technique will be used.   "
183921|NCT00250198|"     This study will test whether a new experimental drug called STA-5326 mesylate will decrease     inflammatory chemicals called cytokines in patients with Crohn's disease. The drug has     prevented gut inflammation in mice and rats and has improved symptoms in humans with active     Crohn's disease.      Patients with Crohn's Disease between 18 and 75 years of age and who have active disease     symptoms may be eligible for this study. Candidates are screened with a review of their     medical records, a medical history and physical examination, electrocardiogram, blood and     urine tests, chest x-ray and tuberculin skin test. They fill out diary cards for 7 days     (measuring their symptoms on the Crohn's Disease Activity Index, or CDAI) and complete a     32-item Inflammatory Bowel Disease Questionnaire (IBDQ) that surveys how their disease     affects their live and activities.      Participants have a colonoscopy (an examination of the colon using a lighted tube) before     starting the study medication. Colon tissue samples are biopsied during the procedure.     Following the colonoscopy, patients are randomly assigned to receive either STA-5326 mesylate     or placebo (sugar or dummy pill). They take four tablets a day and are seen in the clinic     once a week (days 1, 8, 15, 22 and 29) for the following tests and procedures:        -  Physical examination - Days 1, 8, 15, 22, 29        -  Blood tests - Days 1, 8, 15, 22, 29        -  Pharmacodynamic study (blood collected before the first dose of medicine and again after          1, 2, 4, 6 and 8 hours to measure levels of the drug in the blood) - Day 1        -  CDAI and IBDQ - Days 1, 15, 29        -  Review of medications and symptoms - Days 1, 8, 15, 22, 29        -  EKG - Days 8, 29        -  Pregnancy test for women of child-bearing potential - Days 15, 29        -  Urine test - Day 29      After patients complete the above treatment and tests, they undergo a second colonoscopy     within 48 hours of their last dose of study medication and may be offered another 1-week     supply of medication. Those for whom additional treatment is deemed potentially beneficial     are offered another 4-week course of drug or placebo (continuing whichever they took the     first 4 weeks). They come to the clinic for two visits 2 weeks apart (days 43 and 57) for a     physical examination, blood tests, EKG, pregnancy test for women, CDAI, IBDQ and review of     medications and symptoms. A urine sample is collected only on day 57. A third colonoscopy is     done after all the tests are completed on day 57, within 48 hours after the last dose of     study medication.      Patients return to the clinic about 1 week after their final dose of study medication (day 36     for patients who complete only 1 month of treatment and day 64 for those who complete a     second month of treatment) for a limited physical examination, blood tests, pregnancy test     for women, CDAI and IBDQ, and a review of their medications and symptoms.   "
183922|NCT00250211|"     The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a     tumor more accurately allowing a more targeted delivery of radiation. The investigators hope     to learn whether tomotherapy will be able to deliver higher radiation doses safely to the     tumor while sparing the surrounding normal tissue.   "
183923|NCT00250224|"     A new method for localization of the prostate during external beam radiotherapy. The method     is based on insertion of a new thermo-expandable Ni-Ti stent. The radiological properties of     the stent are used for precise prostate localization during treatment using electronic portal     images   "
183924|NCT00250237|"     In this study the investigators want to determine if treatment with haloperidol direct     post-operatively after acute hip surgery in high risk patients protects against developing a     post-operative delirium.   "
183925|NCT00250250|"     Children with growth failure due to inadequate secretion of growth hormone or growth     retardation due to Turner's syndrome are individually dosed and treated for 12 weeks   "
183944|NCT00250497|"     The New Moves study will evaluate the impact of a school based program for inactive high     school girls who are overweight or at risk for being overweight due to low levels of physical     activity. The primary study hypothesis is that girls in the intervention schools will     significantly decrease their percent body fat as compared to girls in the control schools.     Secondary research hypotheses include that girls in the intervention condition will     significantly increase their physical activity levels and improve the quality of their     dietary intake.   "
183945|NCT00250536|"     This is a study to find out whether an exercise program during dialysis or a drug called     nandrolone decanoate can increase muscle size and strenght in patients on dialysis.   "
184014|NCT00251433|"     This is a two-part study (Phase I/Phase II). Part I is designed to find the optimal (best)     doses of GW572016, docetaxel, and trastuzumab when given together, Part II is designed to     evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all     three drugs compared to patients receiving only docetaxel and trastuzumab.   "
183926|NCT00250263|"     Allergic diseases represent a major health issue worldwide. Mainstay treatment is allergen     avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the     advantages of specific treatment with long lasting efficacy, and can modify the course of     disease. However, use of this treatment is restricted by the high risk of adverse events     especially in asthmatics. Other, better tolerated, routes of allergen administration than the     current conventional subcutaneous route (SCIT) have been investigated including sublingual     (SLIT). However, the immune parameters of SLIT have not been examined. We propose conducting     a randomised, placebo-controlled study of a commercially-available SLIT for house dust mite     (HDM) allergy to investigate induction of relevant T cell regulatory immune mechanisms. The     first year will be followed by an optional open label extension period. Immunoregulatory     cytokine synthesis and T cell phenotype and function (real time PCR and flow cytometry) will     be examined. This project will provide important fundamental knowledge on which to base     improved and greater application of this potentially curative treatment for allergy. SLIT has     the potential advantage of home administration and suitability for patients with asthma who     are currently unable to access many of the allergen desensitising regimens.   "
183927|NCT00250276|"     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.     Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can     lead over time to cervical cancer in women . This study will compare the immune response     induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the     manufacturing process.   "
183928|NCT00250289|"     the use of a herbal formulation containing sage, echinacea,lavender and mastic gum would     prevent oral malodor if delivered in an appropriate delivery system to enable slow release of     the active ingredients.   "
183929|NCT00250302|"     Mesenchymal stem cells are found in bone marrow, and have the ability to differentiate into     different tissue types. The primary objective of the study is to examine the safety of using     such cells to treat patients suffering from distal tibial shaft fractures. The cells will be     isolated from the patient's bone marrow, loaded onto a carrier and implanted locally at the     fracture site.   "
183930|NCT00250315|"     Patients with cirrhosis have a altered cardiac response to stress. This study evaluate the     cardiac response by MRI during dobutamine stress. Hypothesis: impared increase in cardiac     output, cardiac index, ejection fraction.   "
183931|NCT00250328|"     The study involves adult subject requiring colonic anastomosis following laparoscopic     intra-corporeal surgery. The anastomosis will be performed by using nitinilclip by the LapCAC     device instead of staplers.      Endpoints: safety-Functioning secured anastomosis and no occurrence of adverse event related     to device use.      The efficacy endpoint of this study includes clinical evaluation of characteristic parameters     related to intestinal surgeries.      Discharge day (or ready-for-discharge) Proven anastomotic leak rate (clinically or     radiological) Stenosis / stricture at anastomosis Patient recovery level will be assessed     every day during hospitalization and in the follow up visits.   "
183933|NCT00250354|"     The purpose of the study is to assess the safety and effectiveness of oral risperidone (an     antipsychotic medication) in the treatment of conduct disorder and other disruptive behavior     disorders in children ages 5 to 12 with mild, moderate, or borderline mental retardation.   "
183934|NCT00250367|"     The purpose of the study is to evaluate the effectiveness and safety of risperidone (an     antipsychotic medication) versus placebo as add-on therapy to mood stabilizers, in the     treatment of manic episodes associated with bipolar disorder.   "
183935|NCT00250380|"     The purpose of this study is to determine the clinically meaningful definition and prevalence     of aspirin resistance based on data linking aspirin-dependent laboratory tests to recurrent     vascular events in cardiovascular patients taking aspirin.   "
183936|NCT00250393|"     To establish the efficacy of 40 mg/day doses of istradefylline for the change in Unified     Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with     Parkinson's disease (PD).   "
183937|NCT00250406|"     The purpose of this study is to determine the clinical effects of a triclosan stent on     adherent bacteria, stent biofilms, and patient urine cultures in patients with an indwelling     triclosan ureteral stent. The patient populations that will be tested include: patients     following ureteroscopy and patients scheduled to undergo shockwave lithotripsy who require a     ureteral stent. It is hypothesized that triclosan eluting ureteral stents will reduce the     number of bacteria both on (within biofilm) and around (in the urine) a ureteral stent.   "
183938|NCT00250419|"     To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as     intramuscular injections followed by electrostimulation in cancer patients.   "
183939|NCT00250432|"     Comparison of the safety and effectiveness of standard drug dosing versus a daily dose 3     times higher than the standard dose in patients with invasive candidiasis (bloodstream and/or     systemic yeast infections)   "
183940|NCT00250445|"     The study is designed to compare the risk of cardiovascular events (heart attacks, strokes)     in patients receiving either etoricoxib or diclofenac. It will also compare the     gastrointestinal tolerability of the two medicines. The study will be conducted in patients     with either rheumatoid or osteo-arthritis.   "
183941|NCT00250458|"     Study to test the effectiveness of a marketed drug in the treatment of migraine-associated     nausea.   "
183942|NCT00250471|"     The primary purpose of this study was to compare the efficacy and safety of bivalirudin to     eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high     risk for heart attack and other cardiovascular complications who will undergo surgery to open     up blocked arteries in the heart.   "
183943|NCT00250484|"     The researchers aim to study the effects of repetitive transcranial magnetic stimulation     (rTMS) on chronic visceral pain in patients with idiopathic chronic pancreatitis.   "
183987|NCT00251082|"     To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone     versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months     and to investigate the bleeding pattern over a treatment period of one year   "
184061|NCT00252057|"     The purpose of this study is to determine if the Re-Engineered Discharge will decrease     rehospitalization rates and adverse events of patients leaving Boston Medical Center.   "
183946|NCT00250549|"     OraQuick is a safe, rapid test that accurately identifies HIV in as little as 20 minutes. By     providing an accurate, quick method for detecting a person's serostatus and access to     immediate post-test counseling, rapid testing has a crucial role in identifying HIV status     and improving post-test counseling rates in populations who are at high risk of HIV infection     and high failure to return rates. This prospective randomized control trial compared the     educational effectiveness of a fifteen-minute post-test counseling video with the normal     practice of a session with an HIV counselor.   "
183947|NCT00250562|"     Valsartan, an orally active angiotensin II receptor blocker, is registered in most countries     worldwide for the treatment of hypertension. In China the usual recommended starting and     maintenance dose is 80 mg o.d. The combination of HCTZ 12.5 mg with valsartan 80 mg has been     shown to have additive effects in lowering blood pressure compared to valsartan 80 mg in     patients not adequately controlled by valsartan 80 mg monotherapy5 or in non-selected     patients6. This fixed combination is registered in most countries worldwide.      The potential benefits of these combinations should be evaluated in patients not adequately     controlled by valsartan 80 mg monotherapy. This study will compare the efficacy, safety and     tolerability of adding HCTZ 12.5 mg to valsartan 80 mg in those hypertensive patients.      This study is not recruiting in the US.   "
183948|NCT00250575|"     Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of     clozapine in patients with treatment-resistant schizophrenia.      This study is not recruiting in the United States.   "
183949|NCT00250588|"     The purpose of this study is to determine whether Problem-Solving Skills Training is     effective in reducing barriers to health care and improving health-related quality of life     for children with persistent asthma.   "
183950|NCT00250601|"     The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)     in patients with depression.      The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to     placebo in patients with depression.      The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy     of saredutant on disability and quality of life in patients with depression, and to evaluate     blood levels of saredutant.   "
183951|NCT00250614|"     The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)     in patients with depression.      The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to     placebo in patients with depression.      The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy     of saredutant on disability and quality of life in patients with depression, and to evaluate     blood levels of saredutant.   "
183952|NCT00250627|"     The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)     in patients with depression.      The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to     placebo in patients with depression.      The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy     of saredutant on disability and quality of life in patients with depression, and to evaluate     blood levels of saredutant.   "
183953|NCT00250640|"     This is an observational study to monitor the continued effectiveness of Ventavis (inhaled     iloprost) in the long-term. The study observes the effects and the safety of Ventavis     inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from     around 30 study sites in Europe will be included in the study. This observational study will     collect information in patients receiving a medication that is already available on     prescription in the participating countries. Ventavis is used to treat moderate cases of     primary pulmonary hypertension.   "
183954|NCT00250653|"     The purpose of the study is to evaluate the long-term safety of saredutant (or SR48968C) in     adult and elderly patients with depression.The primary objective is to evaluate the long-term     safety and tolerability of a 100 mg dose of saredutant in adult and elderly patients with     depression. The secondary objective is to evaluate blood levels of saredutant.   "
183955|NCT00250666|"     The current study aims to validate the diagnostic use of PCT assessing its capability to     individualize and shorten the duration of antibiotic therapy in critically ill patients with     suspected or confirmed sepsis.      In particular, no well-designed intervention study has properly examined the following     hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic     treatment duration in critically ill patients with suspected or documented sepsis, without     harming patient safety.   "
183956|NCT00250679|"     To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a     period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).   "
183957|NCT00250692|"     Our proposal is to study infants in the Neonatal Intensive Care Unit (NICU) who are     undergoing a heel stick for blood sampling, a standard procedure in patient care. Currently,     these infants do not get any pain relief for this procedure. Several recent clinical studies     have shown the usefulness of nitrous oxide (laughing gas) for treating pain for minor     procedures in children 0 to 18 years, but these effects have not been exclusively studied in     the newborn and infant populations. Animal studies have questioned the anti-nociceptive     (pain-blocking) effect of nitrous oxide in very young animals. It is unclear if this also     applies to humans. The reason for this difference may be due to an immaturity of the neural     pathways that modulate pain in the very young. The purpose of this study is to investigate     whether or not nitrous oxide has an analgesic (pain-relieving) effect in infants undergoing     minor procedures in the neonatal period (less than 3 months).   "
183958|NCT00250705|"     The proposed study will be a 6-week open label study evaluating aripiprazole in the treatment     of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct     disorder. The initial dose depending on the weight of the patient will be as follows: < 25 kg     = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003,     Bristol-Myers Squibb). For the first two weeks of the study, the dose will be flexible based     on response and tolerance and thereafter will remain fixed.   "
183959|NCT00250718|"     1.1 To determine the efficacy of a combination treatment of VP-16, chlorambucil,     dexamethasone, and vincristine in patients with relapsed/refractory hematological     malignancies.      1.2 To determine the toxicity profile of the above regimen in this patient population.      1.3 Evaluate the effect of low dose administration of chemotherapy on angiogenesis, and     correlate this with tumor responses.   "
183960|NCT00250731|"     Research has shown that diabetes affects both the patient and family, and that support from     family and partners helps diabetes patients manage their illness better. However, diabetes     programs rarely involve the partner. This is a study to develop and test an intervention that     helps partners and patients who have type 2 diabetes better support each other. The     intervention will be delivered over the telephone to reach more people. Our hypothesis is     that an intervention that targets the couple has a greater effect on health and well-being of     patients than one that targets the individual patient alone.   "
183961|NCT00250744|"     1. To compare the effectiveness of gabapentin (titrated to300mg TID days -2 to 5) with          aprepitant (125mg on day 1 and 80mg on days 2 and 3) in the control of delayed nausea          and vomiting associated with level 3, 4 or 5 emetogenic chemotherapy in patients who          experienced delayed nausea and/or vomiting during their first cycle of chemotherapy.        2. To evaluate and compare the safety profile associated with each anti-emetic regimen.        3. To assess subject satisfaction with anti-emetic therapy.   "
183962|NCT00250757|"     To develop the hypothesis that quantitative NMR spectroscopy of human semen can be used to     diagnose prostate cancer.   "
183963|NCT00250770|"     The purposes of this study are the following:        1. To further characterize and quantify both CSF-1 and colony-stimulating factor-1 receptor          (CSF-1R) expression from additional tumor specimens, specifically, tumors of high grade          and from metastatic sites.        2. To assay using Enzyme-Linked ImmunoSorbent Assay (ELISA) sandwich monoclonal antibody          methodology, CSF-1 expression in the peritoneal fluid and blood from patients with          endometrial adenocarcinomas.        3. Using immunohistochemistry, to evaluate the presence of staining for CSF-1 and CSF-1R          from additional patients with endometrial adenocarcinomas, especially of high grades and          from metastatic sites.        4. To determine the extent of cytokine, specifically CSF-1, but also interleukin-1 (IL-1),          IL-6, and granulocyte-macrophage colony-stimulating factor (GM-CSF), production, in          endometrial carcinoma cells in primary cell culture.        5. To determine the responsiveness of epithelial cells on estrogen and antiestrogen          binding, to determine if CSF-1 production is mediated, in these cells, by estrogen          receptor binding, or alternative pathways of intracellular/cell-cell signal          transduction.        6. The ultimate objective of these experiments is to characterize CSF-1 expression from          benign and tumor cells in order to identify steps in the CSF-1 activated signalling          pathways that may represent potential targets for therapy.   "
183964|NCT00250783|"     The purpose of this study is to provide a repository for long-term storage of endometrial     cancer tumor and normal tissue, ascites and serum. This material will be used in studies to     better understand the molecular biology of endometrial cancer.   "
184034|NCT00251706|"     Rapid heart rhythms originating from the upper heart chambers (atrial tachyarrhythmias) are     very common after open-heart surgery. The hypothesis of the PAPABEAR study is that a brief     (13 day) peri-operative course of oral amiodarone therapy would be effective and safe for the     prevention of these post-operative atrial tachyarrhythmias.   "
183965|NCT00250796|"     Primary Aim Determine the response rate and time to progression of the combination of     thalidomide, interferon, and octreotide in patients with unresectable hepatocellular     carcinoma (cancer of the liver that can't be treated surgically).      Secondary Aims        1. Determine the toxicity of this combination in this population.        2. Determine the survival of this patient cohort treated with the combination.        3. Determine the percent of patients with hepatocellular carcinoma who have a positive          octreotide scan.   "
183966|NCT00250809|"     CVC Pros and Cons of scheduled Triple-lumen Central Venous Catheter Exchange: A Prospective     Controlled Randomized Study   "
183967|NCT00250822|"     To determine the primary end point response rate of the combinations of Gemcitabine and     Oxaliplatin (Gem-Ox) in the treatment of hepatocellular carcinoma (HCC) in patients with     platelet counts greater 100,000 per microliter in a single arme Phase II trial.      To determine the toxicity profile of this regimen To determine the effect of this treatment     on patient survival, time to treatment failure, time ot progression, time to response.   "
183968|NCT00250835|"     A combination of chemotherapy and radiation is often used to treat rectal cancer patients     before surgery in an effort to shrink the tumor and make it easier to remove as well as to     help increase the chances of sphincter-sparing surgery. Many previous clinical studies have     suggested that rectal cancer patients may survive longer if the surgery results in a     pathological complete response - that is, the absence of any tumor cells in the surgical     specimen. However, there is still controversy over this. This study attempts to start to     answer this question by treating rectal cancer patients with a combination of chemotherapy     drugs (oxaliplatin and capecitabine), a cyclooxygenase-2 (COX-2) enzyme inhibitor and     radiation before surgery. The rates of pathologic complete response, sphincter-sparing     surgery, and disease-free survival are some of the therapeutic endpoints that will be     studied.   "
183969|NCT00250848|"     Potential participants in the Lung Cancer Case Registry will be all patients diagnosed or     evaluated for possible treatment of lung cancer at the Cancer Research and Treatment Center     (CRTC) and New Mexico Veterans Health Care System (NMVHCS).   "
183970|NCT00250861|"     The purpose of this research study is to find out if treatment with rituximab in combination     with aldesleukin (compared to rituximab alone) decreases the risk of cancer returning, as     well as determining what other effects (good and bad) this drug combination has on NHL.     Rituximab and aldesleukin are not approved in combination by the Food and Drug Administration     (FDA) for the treatment of non-Hodgkins lymphoma; however, Rituximab is approved for use by     itself to treat NHL.   "
183971|NCT00250874|"     To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate     absence of negative interactions among the 3 drugs administered   "
183972|NCT00250887|"     This study aims to determine effectiveness of Gefitinib (Iressa) in recurrent glioblastoma     after standard treatment (surgery, radiationtherapy and at least a first line chemotherapy).     Gefitinib is a specific inhibitor of the epidermal growth factor receptor (EGFR). EGFR is     elevated in more than 50% of malignant gliomas. At recurrence, secondary surgery and pre- and     postoperative Gefitinib is offered to patients in good performance status. Clinical outcome     of patients and correlation to translational research will be evaluated.   "
183973|NCT00250900|"     To determine if a wait and see prescription for ear infections in childhood reduces use of     antibiotics compared to an immediate prescription   "
184062|NCT00252070|"     The purpose of this study is to develop and evaluate a progressive, land-based exercise     program, that includes muscular and aerobic conditioning, resistance and stabilization     exercises and balance training, for persons with arthritis.   "
183974|NCT00250913|"     Purpose: The purpose of this project is to determine how effective the telephone-based     counseling program is at helping patients with heart disease become more physically active.      Hypotheses to be tested:        -  Compared to usual care, patients in the physical activity counseling program will:             1. significantly increase total distance measured by an accelerometer and minutes of               physical activity at a moderate intensity or higher,             2. have significantly higher generic and heart-disease health-related quality of life,               and             3. will lead to greater improvements in the mediators of behavior change (psychosocial               variables, i.e. self-efficacy, outcome expectations, etc.) at 26 and 52 weeks;        -  Changes in the mediators of physical activity will predict changes in physical activity          outcomes at 26 and 52 weeks;        -  The physical activity counseling program is preferable to usual care from the          perspective of health care system costs.   "
183975|NCT00250926|"     The purpose of this study is to find out if the combination of bortezomib (Velcade),     dexamethasone (Decadron) and rituximab (Rituxan) is effective in treating Waldenstrom's     macroglobulinemia.   "
183976|NCT00250939|"     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the     body's cells to break down glycogen (a stored form of sugar) within specialized structures     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates     and is stored in various tissues, especially heart and skeletal muscle, which prevents their     normal function. The overall objective is to evaluate the safety, pharmacokinetics (PK) and     efficacy of Myozyme treatment.   "
183977|NCT00250952|"     It is thought that the amount of fluid used to dilute Botox for injection has an effect on     the quality of the result and the duration of effect on the treatment of upper face rhytides,     even though the dose remains the same.      The study was designed to test this thinking, using the crow's feet wrinkles as the treatment     area.   "
183978|NCT00250965|"     The objective of our research is to determine whether treatment with magnesium will reduce     the incidence of atrial fibrillation in patients undergoing cardiac surgery. Several small     studies of magnesium have already been conducted, but these studies were small and the     results conflicting. A large, well-conducted study of magnesium treatment is required to     definitively determine whether magnesium is effective in preventing this common complication     after surgery. In addition, our study will include patients undergoing valvular surgery, a     group previously excluded from research despite the fact that they are at increased risk of     atrial fibrillation.   "
185089|NCT00268892|"     The purpose of this extension study was to collect long-term safety and tolerability     information to support a marketing authorisation application for a three-month dosage regimen     of degarelix.   "
183979|NCT00250978|"     Your lung cancer has caused fluid to build up in the space around your lung. This fluid is     called a malignant pleural effusion. This fluid takes up space in your chest, and prevents     your lung from fully filling with air. As a result, you may be experiencing shortness of     breath, cough, or chest discomfort. Your doctors have determined that you would feel better     if a surgeon or pulmonary specialist removed this fluid immediately. Your doctors are     offering to admit you to the hospital, and drain the fluid using a Pleur-XTM catheter.      Once the Pleur-X catheter is in place, your doctors would like to start your chemotherapy.      Your doctors have decided to treat you with chemotherapy. If the chemotherapy works to kill     the cancer cells in your body, the cancer will make less fluid, and your doctors will be able     to remove the Pleur-XTM catheter sooner.      It is possible that adding a second drug to the chemotherapy, called bevacizumab may make he     fluid dry up even faster. It is not known whether adding bevacizumab to chemotherapy for     patients with a Pleur-XTM catheter in place is more helpful, or potentially more harmful,     than using chemotherapy alone. For this reason, only patients enrolled in this research     protocol can receive both chemotherapy and bevacizumab while they have a Pleur-XTM catheter     in place.      The purpose of this research study is to determine whether chemotherapy may be delivered     safely with a Pleur-XTM catheter in place.   "
183980|NCT00250991|"     The purpose of this study is determine the effects of using of a combination of two     drugs--integrilin (eptifibatide) and activase (recombinant tissue plasminogen activator,     rt-PA, or recombinant t-PA)--to dissolve blood clots in patients who have a stroke.   "
183981|NCT00251004|"     The purpose of this study was to compare the safety and efficacy of three immunosuppressive     treatment regimens following a kidney transplant.   "
183982|NCT00251017|"     Transporters in kidney are critical in detoxification and elimination of xenobiotics from     systemic circulation, and thus are major determinants of drug response and sensitivity.     Transporters in the renal epithelium control the exposure of renal cells to nephrotoxic drugs     and environmental toxins and thus determine xenobiotic-induced nephrotoxicity. Organic anion     transporters (OATs) and organic cation transporters (OCTs) are two major classes of secretory     transporters in the mammalian kidney. Among the uptake transporters, OAT1, OAT3, or OCT2     appear to be particularly important in the renal basolateral membrane to transport a large     variety of endogenous and therapeutic compounds.      Recently, rapid advances in single nucleotide polymorphisms (SNPs) mapping can now be applied     to characterize the individual patients who suffer adverse effects to a drug, or those for     whom a drug shows efficacy. The aim of this study was to identify and functionally     characterize OCT2 variants as a first step towards understanding whether genetic variation in     OCT2 may contribute to interindividual differences in renal elimination of vancomycin.     Taiwanese patients will be screened and 12 coding region variants of OCT2 will be identified.     The non-synonymous variants of OAT1, OAT3, or OCT2 will then be constructed and characterized     using in vitro human renal cell models. It is to establish whether genetic variants in OAT1,     OAT3, or OCT2 are likely significant contributors to intersubject variability in drug     response. In addition, approaches toward prevention of some drug-induced nephrotoxicity are     discussed, based on molecular mechanisms of renal accumulation of these drugs. Perhaps the     researchers' understanding of OAT1, OAT3, or OCT2 in pharmacogenomics may contribute to the     goal of individualized drug therapy. Development of new strategies based on the understanding     of their cellular handing may achieve safer and more effective therapy for personalized     medicines.   "
183983|NCT00251030|"     To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy     subjects   "
183984|NCT00251043|"     This study will evaluate the effectiveness of interpersonal psychotherapy in treating     pregnant women with depression.   "
183985|NCT00251056|"     Many cystic fibrosis patients die of lung failure caused by repeated lung infections from     thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the     clearance of mucus by altering its rheology and replenishing the airway surface liquid layer     in these patients, thereby enhancing the shift of stagnant mucus from the lungs. The study     aim is to determine the optimal dose of mannitol to generate clinical improvement in patients     with cystic fibrosis.   "
183986|NCT00251069|"     Glucosamine sulphate causes no changes in blood levels of cholesterol   "
183988|NCT00251095|"     The purpose of this study is to compare the objective response rates of patients randomized     to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every     week to patients with metastatic breast cancer. The study hypothesis is that the objective     response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with     Taxol given every week.   "
183989|NCT00251108|"     The aim of this project is to compare the efficacy of two different fitness exercise     programmes on improving fitness and psychosocial functioning in a traumatic brain injured     population. We hypothesize that a supervised fitness-centre based exercise programme,     compared to an unsupervised home-based exercise programme will show significant improvements     in cardiorespiratory fitness, depression and community integration.   "
183990|NCT00251121|"     Patients complaining of tachycardia but with a negative Holter ECG, are for a limited time     period offered a simplified electrophysiological(EP) examination. By a full     electrophysiological study(EP study)electrodes are introduced for pacing and sensing i all     four heart chambers. Where as by the mini invasive EP study only one electrode is introduced     to the right atrium. The simplified procedure represent a smaller risk of complications,     requires less resources but should yield the same diagnoses in more than 90% of the cases.     The study is a feasibility study to see if the procedure can discover arrythmias in a fairly     unselected patient population.   "
183991|NCT00251134|"     Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The     major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of     recent trials hint that the course of CAD may be positively influenced by an increased intake     of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an     acute myocardial infarction. They are divided into two groups, both receiving standard     post-infarction therapy. The subjects of one group additionally receive 1 gram of omega     3-fatty acids daily for a time-period of 12 months, while the subjects in the second group     receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported     and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty     acids.   "
183992|NCT00251147|"     This study compares standard open rotator cuff repair versus arthroscopic mini-open rotator     cuff repair by measuring the disease-specific quality of life at 2 years in patients with     full thickness rotator cuff tears.      Hypothesis: There is no difference in disease-specific quality of life outcome at two years     between open versus arthroscopic mini-open repair for patients with full-thickness rotator     cuff tears.   "
185090|NCT00268905|"     The purpose of this study is to determine the maximum tolerated dose (MTD) and to explore the     safety and anti-tumor activity of E7389 in combination with carboplatin in patients with     advanced solid tumors.   "
183993|NCT00251160|"     This trial will compare the effectiveness of electrothermal arthroscopic capsulorrhaphy     (ETAC) to the current reference standard procedure, open inferior capsular shift (ICS), for     the treatment of shoulder instability caused by ligamentous capsular redundancy.     Multi-directional instability (MDI) and multi-directional laxity with anteroinferior     instability (MDL-AII) are the two types of shoulder instabilities included in this trial.      Hypothesis: There is no difference in disease-specific quality of life between patients     undergoing an ETAC versus an open ICS for the treatment of shoulder instability caused by     capsular ligamentous redundancy.   "
183994|NCT00251173|"     The proposed study will compare three alternative interventions in the emergency department     (ED) to promote linkage to substance abuse assessment, referral and treatment entry for those     who meet abuse/dependence criteria for stimulants, cannabis, and/or non-injected opioids: (1)     a 5-session Strengths-Based Case Management (SBCM) model; (2) a 2-session Brief Motivational     Enhancement (BME); or (3) a one-time Brief Informational Feedback (BIF) session. The primary     outcome variables for this trial include receiving an assessment and referral and treatment     entry. Other outcomes include degree of treatment completion, substance-related measures,     health service utilization, health status changes, and psychosocial factors.   "
183995|NCT00251186|"     This is a Phase II clinical trial measuring the effectiveness of the combination of     Capecitabine and cetuximab for first line treatment of colorectal cancer in elderly patients     and/or those with multiple comorbidities unable to receive standard chemotherapy. This study     will be open approximately 2-3 years. Approximately 36 patients will be enrolled on this     study. The study will begin enrolling at The Cancer Institute of New Jersey, with 17 patients     in the first group. If more than 4 responses are noted, the accrual will continue to 36     patients throughout CINJOG.   "
183996|NCT00251199|"     VX-950 is an investigational drug , which is being tested in combination with a known     treatment for hepatitis C, peginterferon.   "
183997|NCT00251212|"     This study is designed to address both alcohol misuse and violence among adolescents ages     14-18 seeking care in an urban emergency department (ED). The study is a randomized     controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing     and Skills Training intervention, delivered either by a computer or by a counselor, and an     informational handout control condition.   "
183998|NCT00251225|"     The purpose of this study is to determine the effectiveness of two drugs, docetaxel and     Gleevec®(also called imatinib), in prostate cancer that no longer responds to hormone     therapy. The investigators are interested in finding out if the combination of these two     drugs is more effective than docetaxel alone in the treatment of prostate cancer.   "
183999|NCT00251238|"     The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with     the primary Raynaud phenomenon, with regards to the frequency, duration and severity of     vasospastic attacks.   "
184000|NCT00251251|"     Congestive heart failure (CHF) is a common health problem that leads to frequent     hospitalizations and an increased death rate. In spite of advances in drug therapy, it     remains a significant public health problem. Recently, a new therapy has been developed for     advanced heart failure patients with a ventricular conduction abnormality. This new therapy,     called cardiac resynchronization (CRT), is a device which stimulates the atrium, the right     ventricle, and the left ventricle providing synchronization of the contraction of the heart     chambers. It is the addition of this therapy to an implantable cardioverter defibrillator     (ICD) that will be evaluated in this study. This study will compare whether the implantation     of this new therapy device, in combination with an implantable cardioverter defibrillator,     will reduce total mortality and hospitalizations for CHF.   "
184204|NCT00253071|"     The purpose of this study is to determine whether early integrated prophylactic combined     medical and psychological outpatient treatment is associated with a better prognosis in     patients with severe unipolar and bipolar affective disorders than standard treatment.   "
184001|NCT00251264|"     The purpose of this study is to compare arthroscopic and open shoulder stabilization     procedures by measuring the disease-specific quality of life outcome in patients with     traumatic unidirectional anterior instability of the shoulder at 2 and 5 years.      Hypothesis: There is no difference in disease-specific quality of life outcomes in patients     with traumatic unidirectional anterior shoulder instability, undergoing an arthroscopic     versus an open stabilization procedure.   "
184002|NCT00251277|"     The purpose is to evaluate safety and feasibility of the use of Rituximab as an adjunct to     standard therapy (plasmapheresis + steroids) for patients with thrombotic thrombocytopenic     purpura (TTP). This includes evaluating the rate and type of treatment failure.   "
184003|NCT00251290|"     Generalist physicians in the outpatient setting care for 80% of the 300,000 patients who have     transient ischemic attacks (TIA) annually in the United States. Despite existing secondary     prevention therapies, recurrent ischemic events are common following a TIA. Given the risk of     poor outcomes and the important role of the generalist, new therapeutic approaches for     patients with TIA are needed that can be applied by generalists to outpatients. This research     will develop and evaluate a new therapeutic approach that centers on the observations that     sleep-disordered breathing is a risk factor for cerebrovascular and cardiovascular disease,     is common in patients with cerebrovascular disease, and is associated with poor outcome     following a stroke or TIA. We posit that diagnosing and treating sleep-disordered breathing     in the home of TIA patients can improve cerebrovascular and cardiovascular outcomes.      The primary aims are to determine in TIA patients: 1) the prevalence of sleep-disordered     breathing, 2) the feasibility of diagnosing and treating sleep-disordered breathing using an     auto-titrating continuous positive airways pressure (auto-CPAP) machine within 24-hours of     TIA symptom onset, 3) adherence to auto-CPAP, and 4) the effect of auto-CPAP on blood     pressure.      We will recruit 80 TIA patients to be randomly assigned to either the intervention or the     control groups. Each patient in the intervention group will use an auto-CPAP machine for up     to 90 days and will then receive an unattended sleep study using a sleep monitor. Each     patient in the control group will receive two unattended sleep studies, one upon enrollment     and another after 90 days.   "
184004|NCT00251303|"     This study will examine the effectiveness of riluzole for treating Obsessive-Compulsive     Disorder in Youth, Including those with Autism Spectrum Disorders.   "
184005|NCT00251316|"     This study will examine the safety and effectiveness of using lithium, which has been used to     enhance the effectiveness of high-dose 131I, with a single low dose (30 mCi) of 131I for     thyroid ablation in patients with recently diagnosed papillary or follicular thyroid cancer     who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid.      Participants are randomly assigned to receive lithium capsules or placebo (look-alike     capsules with no active ingredient). They follow a low-iodine diet for 2 weeks before     starting treatment and are then admitted to the NIH Clinical Center for study and treatment     for 11 days, during which they remain on the low-iodine diet. Blood samples are collected     almost every day to analyze thyroid hormones, kidney and liver function, lithium     concentrations and other tests.   "
184006|NCT00251329|"     The purpose of this study is to determine if this combination is safe and effective in this     situation especially to increase the rate of pathological complete response (PCR). Women with     large tumors and or lymph node involvement at the time of initial diagnosis may benefit from     receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of     tumor involvement before surgery. If chemotherapy given before breast surgery is effective in     decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible.     This new combination may be better tolerated than other commonly used regimens and, to date,     appears to be at least as effective.   "
184007|NCT00251342|"     The objective of the present study is to evaluate the effectiveness of postnatal depression     screening by comparing the mental health outcome (at 6 months postpartum) of mothers under     the Edinburgh Postnatal Depression Scale (EPDS) screening programme versus usual clinical     practice (usual practice), using randomized controlled trial design. With the use of the EPDS     for the screening of postnatal depression, it is expected that more mothers in need of     intervention (including mental health intervention, guidance in childcare and parenting,     counseling in family relationships, etc) will be picked up and offered appropriate     intervention, compared to the usual practice. It is hypothesized that the mental health of     the group of women under the EPDS screening programme will be better than those under the     usual practice, on subsequent follow-up.   "
184008|NCT00251355|"     The purpose of this study is to test a new treatment of pancreatic cancer that cannot be     removed by surgery. This treatment is a Phase I dose escalation research study which will     combine one drug at increasing doses with a fixed dose of a second drug and radiation     therapy. The drug that will be used at increasing doses is gemcitabine whereas 5-fluorouracil     will remain the same for all patients.   "
184009|NCT00251368|"     The purpose of this study is to evaluate the side effects of 9-Aminocamptothecin (9-AC) and     to determine the best dose which should be used to treat leukemia.   "
184010|NCT00251381|"     The purpose of this study is to determine the 1-year rate of locoregional disease control in     the experimental arm, using a control arm to avoid selection bias.   "
184011|NCT00251394|"     The main purpose of this study is to determine the effects (good and bad) and the safety of     Dynavax's immunostimulatory phosphorothiolate oligodeoxyribonucleotide (1018 ISS) given in     combination with Rituxan on patients with B-cell follicular non-Hodgkin's lymphoma. This     research is being done because recurrent follicular non-Hodgkin's lymphoma is not curable     with standard chemotherapy or antibody treatments. 1018 ISS is an experimental compound that     consists of short pieces of DNA that stimulate the immune system. It is hoped that 1018 ISS     may improve the ability of Rituxan to kill cancer cells.   "
184012|NCT00251407|"     The purpose of this study is to find the highest dose of the combination of taxotere,     cisplatin and CPT-11, that can be given without causing severe side effects. We also want to     test the safety of this drug combination and see what effects (good and bad) it has on     patients with advanced cancer for which there is no known curable treatment.   "
184013|NCT00251420|"     Therapeutic writing about one's emotions has been described previously (J Pennebaker:     Emotions, disclosure and health. Am Psychol. Assoc 1995). The present project will compare     the effects (if any) of writing about the emotional versus the physical consequences of lung     disease on anxiety, perceived quality of life, and perceived health status.   "
184015|NCT00251446|"     This is a Phase II, single-arm study in patients with stage IIIB (with malignant pleural     effusion) and IV NSCLC who have been previously treated with a platinum-based doublet.      Each cycle will be 21 days. On Day 1 of each cycle, patients will receive vinflunine 320     mg/m2 as a 20-minute IV infusion.      Patients will continue to receive study treatment until disease progression or unacceptable     toxicity.      Patients will be evaluated every 2 cycles for response using RECIST criteria.   "
184016|NCT00251459|"     This is a Phase IIIb, single-masked, 1-year multicenter study of the safety and tolerability     of intravitreally administered ranibizumab in subjects with active subfoveal CNV secondary to     AMD.   "
184017|NCT00251472|"     This is a Phase II, open-label, non-randomized study in patients with locally advanced or     metastatic breast cancer.      Each cycle of treatment will be 4 weeks in length. Patients will be radiologically evaluated     every 8 weeks for response. Patients will continue to receive study treatment until disease     progression or unacceptable toxicity.   "
184018|NCT00251485|"     This is a Phase II, open label, non-randomized study in patients with histologically or     pathologically confirmed diagnosis of stage IIIB/IV, EGFR+ adenocarcinoma of the colon or     rectum who have not received prior chemotherapy for their metastatic disease.      Primary Study Endpoint:      To assess the response rate, progression-free survival, and overall safety profile of a     modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with     metastatic colorectal cancer.      Secondary Study Endpoint(s):      To assess overall survival of patients with metastatic colorectal cancer who receive     first-line therapy with a modified FOLFOX 6 + cetuximab regimen.   "
184035|NCT00251719|"     This is a study to assess the efficacy and safety of 8 weeks of treatment with     Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole     (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.   "
184081|NCT00252330|"     To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in     patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive     control. In addition, the tolerability and safety of SR58611A in patients with MDD will be     evaluated.   "
184019|NCT00251498|"     The primary objective of this study is to determine the efficacy (response rate) of cetuximab     when administered in combination with docetaxel and carboplatin for treatment of patients     with advanced non-small cell lung cancer.      The secondary objectives of this study are:        -  to determine the time to progression and overall survival for patients with advanced          NSCLC who are treated with the combination docetaxel, carboplatin , and cetuximab        -  to determine the toxicity of the combination in patients with advanced NSCLC.      Patients with stages IIIB (pleural or pericardial effusion) and IV NSCLC who have not     received any prior chemotherapy will be eligible to participate in the trial. Other     eligibility criteria include: ECOG PS 0-1, normal hepatic and renal function, age >18 years.     Specific inclusion and exclusion criteria are detailed in Sections 4.2 and 4.3.   "
184020|NCT00251511|"     This is a Phase II, open-label, non-randomized study in patients with low, intermediate-1,     intermediate-2, or high-risk MDS (defined by IPSS).      Each cycle of treatment will be 6 weeks in length. Patients will be evaluated every 6 weeks     for response. Patients will be treated for a minimum of 12 weeks even in the absence of     response. Following 12 weeks of treatment, patients will continue to receive study treatment     until disease progression or unacceptable toxicity.   "
184021|NCT00251524|"     This is a Phase II, open-label, non-randomized study in patients with advanced non-squamous     NSCLC.      Each cycle will be 21 days. Patients will be evaluated every 2 cycles (~6 weeks) for response     using RECIST criteria. Those patients achieving stable disease or better will continue     therapy. Those patients experiencing progressive disease will be taken off study.      Patients will receive 6 cycles of Eloxatin, Alimta, and Bevacizumab. After the 6 cycles,     patients will receive Bevacizumab alone every 21 days until evidence of disease progression     or unacceptable toxicity.      Note: Once patient has completed the 6 cycles of Eloxatin, Alimta, and Bevacizumab and is     receiving single-agent Bevacizumab, assessment of response will be performed every 3 cycles     (~every 9 weeks) using RECIST criteria.   "
184022|NCT00251537|"     This is a pilot study to assess the safety and antiretroviral activity of a naturally     occuring substance known as Leukotriene B4(LTB4). The aim of the study is to determine the     effect of LTB4 on viral load during a period of 6 weeks, 4 weeks of active treatment and 2     additional weeks after the end of active treatment for safety follow-up. 40 patients in seven     clinics in Canada will be randomized into three treatment arms, either of two doses of LTB4     or placebo. Study drug is administered intravenously once daily. LTB4 can activate and     stimulate various white blood cells and by the activation release natural substances in the     body and this process is an important part of the body's defense against infections.   "
184023|NCT00251550|"     To investigate efficacy and safety of pemetrexed combined with cisplatin for chemo-naive     patients with Malignant Pleural Mesothelioma.   "
184024|NCT00251563|"     Environmental and genetic factors may play a role in the progression of cancer. The goal of     this project is to establish a series of cross-sectional / case-control studies to evaluate     risk factors of cancer in China.   "
184025|NCT00251576|"     A-Phase: Evaluating patients with chest pain who are receiving approved drugs, to estimate     the effectiveness of one type of blood thinner as compared to another type of blood thinner.      Z-Phase: To evaluate early treatment of patients with long term chest pain (using an approved     drug for 30 days, followed by an increased dose of the drug) as compared to patients (treated     with diet and 4 months placebo followed by diet and approved drug) in patients who have     experienced acute chest pain or heart attack.   "
184026|NCT00251589|"     The reason for this study will be to find the safest maximum tolerated dose of oral     vorinostat in combination with erlotinib [Tarceva (TM)] that can be given to patients with     lung cancer who have relapsed or failed other therapy for the disease. Once the safest     maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial     will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also     be evaluated.   "
184027|NCT00251602|"     The purpose of this study is to learn the effects of genetic make up on response to the drugs     atropine and propranolol, to examine how changes in heart rate and blood pressure can be     measured, and to test a new statistical analysis method.   "
184028|NCT00251615|"     The purpose of this study is to learn what changes in blood vessel contraction may occur as a     result of a disease of the vessel that requires surgery. The study will examine the calcium     channels present in the vessels being operated on, and the genes that may alter blood vessel     function. Possible variation in these genes may change the kind of calcium channels present     in blood vessels.   "
184205|NCT00253084|"     The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release     carbidopa-levodopa in subjects with Parkinson's disease.   "
184029|NCT00251628|"     The purpose of this study is to determine whether around-the-clock dosing of pain medication,     with or without nurse coaching, increases the effectiveness of pain management (i.e.,     decreased pain intensity scores with and without swallowing, increased use of pain     medication, improved sleep, increased oral intake of fluids, decreased negative behaviors,     and the same degree of side effects), over time, compared to standard care with as needed     dosing.   "
184030|NCT00251641|"     This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label     study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the     treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to     severe plaque-type psoriasis for at least 6 months prior to screening (subjects with     concurrent psoriatic arthritis may also be enrolled).   "
184031|NCT00251654|"     The investigators prospectively document infectious, neurological, and other complications or     adverse events occurring during peripheral regional anesthesia via a catheter using     computer-based data recording.   "
184032|NCT00251680|"     The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily     (QD), taken with established lipid-lowering therapy in subjects with type 2 diabetes     mellitus.   "
184033|NCT00251693|"     The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD)     treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in     healing subjects with endoscopically proven erosive esophagitis.   "
184108|NCT00252681|"     The primary purpose of this study is to compare two surgical treatments for perforated     necrotizing enterocolitis in very low birth weight babies.   "
184036|NCT00251732|"     The main objective of this study is to evaluate the role of pain modulation in GERD patients     who fail to obtain clinical relief with standard dose (once daily) PPI. The study will     compare the efficacy of 1) standard dose PPI plus low-dose tricyclic antidepressant (TCA) to,     2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom     resolution and health related quality of life in GERD patients who fail standard dose PPI and     are randomly assigned to one of these three groups.   "
184037|NCT00251745|"     The purpose of this study is to assess the efficacy and safety of daily treatment with     Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD     in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal     reflux disease (GERD).   "
184038|NCT00251758|"     The purpose of this study is to assess the efficacy and safety of daily treatment with     Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD     in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal     reflux disease (GERD).   "
184039|NCT00251771|"     Deep vein thrombosis (DVT) is a severe disease, and conventional treatment with low molecular     weight heparin (LMWH) and warfarin is associated with some degree of long-term sequelae, i.e.     post-thrombotic syndrome (PTS). Catheter-directed thrombolytic (CDT) therapy has been     introduced worldwide the last two decades. Reports have suggested a beneficial effect of this     costly treatment, but there are no randomized clinical trials documenting its short- and     long-term efficacy and safety. This multi-center study will randomize patients with acute     iliofemoral vein thrombosis to either conventional treatment or CDT in addition to     conventional treatment. Main outcome parameters are patency rates at 6 months and prevalence     of PTS at 24 months. The main short-term hypothesis is that CDT of first-time acute DVT will     increase patency of the affected segments after 6 months from <50% to >80%. The main     long-term hypothesis is that CDT will improve long-term functional outcome, i.e. risk of PTS     after 2 years from >25% to <10%.   "
184040|NCT00251784|"     Patients sometimes report subjective visual effects when taking sildenafil. Our study set out     to measure these in a controlled setting. Subjects were asked to detect patterns presented on     a monitor screen.   "
184041|NCT00251797|"     The study will try to answer these questions:        1. What is the highest dose of thalidomide brain cancer patients can receive safely in          combination with irinotecan?        2. How well does this combination work to shrink brain tumors, and how long do responses to          treatment last?        3. What side effects does the combination of drugs cause?        4. How does treatment affect patients' quality of life (how they feel and what activities          they are able to do)?   "
184042|NCT00251810|"     This study aims to test whether two depth-of-anaesthesia-monitors can perform equally well in     monitoring anaesthetic sleep, both at induction and emergence from anaesthesia and during     surgery.   "
184043|NCT00251823|"     Rationale:      ST-elevation myocardial infarction (STEMI) is usually triggered by rupture of an     atherosclerotic plaque that then accumulates platelets and fibrin and leads to an occlusive     coronary thrombus. Clinical benefits obtained with revascularization of the infarct related     artery (IRA) depend on the achievement of four goals:        1. Early reperfusion        2. Full restoration of normal flow in the epicardial vessels        3. Full restoration of flow in the microcirculation, and        4. Preservation of myocardial function.      Reperfusion of the IRA can be achieved pharmacologically with intravenous thrombolytic     agents, or mechanically with percutaneous coronary intervention (PCI). In Canada,     thrombolysis is the current standard of care in most hospitals, although there is mounting     evidence that primary PCI is superior, and many Canadian centres are shifting towards this     strategy. To offer primary PCI to community hospitals without on site cardiac catheterization     facilities, regional programs need to be present that allow rapid transfer to invasive     centers that offer this procedure round-the-clock.      Recent evidence suggests that angiographic and clinical results with primary PCI could be     further enhanced by facilitation with a pharmacological treatment given prior to the     procedure. The present proposal plans to examine the safety and efficacy of eptifibatide to     facilitate coronary angioplasty in STEMI in patients who present to centres with and without     on-site catheterization facilities.      The primary outcome measure will be a composite clinical endpoint including death, recurrent     myocardial infarction, recurrent unstable ischemia, or stroke, at 30 days.      Secondary endpoints include the percent thrombolysis in myocardial infarction (TIMI) grade 3     coronary flow after the PCI, myocardial perfusion score, individual clinical outcomes as     listed for the primary endpoint, resolution of ST-segment elevation, requirement for     subsequent revascularization, frequency of congestive heart failure (CHF), cardiogenic shock,     and Canadian Cardiovascular Society (CCS) angina class.   "
186087|NCT00282815|"     The purpose of this study is to determine if treating stroke patients who have obstructive     sleep apnea with continuous positive airway pressure will improve symptoms caused by the     stroke.   "
184044|NCT00251836|"     The success of kidney transplantation is hampered by the shortage of organs. One attractive     strategy is the use of kidneys from living donors. During the donor operation the kidney     artery, kidney vein and ureter have to be interrupted as far as possible from the kidney to     have sufficient length for the reconnection of these structures in the transplant operation.      An adrenal gland is situated at the upper pole of each kidney. While the arterial supply is     accomplished by many small vessels, the venous drainage is only through one vein. On the     right side the adrenal vein empties directly into the inferior vena cava (the large vessel     transporting blood from the lower body to the heart). In contrast, on the left side the     adrenal vein empties into the kidney vein, which in turn drains to the inferior vana cava.     Due to these anatomical differences a left-sided removal of a kidney always necessitates an     interruption of the left adrenal vein, while a right-sided kidney removal does not.      As the venous drainage of the left adrenal gland is closed during living kidney donation, the     gland is most likely functionally impaired. This can be compared to a right-sided kidney     donation, where the adrenal vein is left intact. These comparisons are performed by adrenal     function tests before, one week after and one month after kidney donation. These function     tests consist of blood values drawn after stimulation with a hormone drug.   "
184045|NCT00251849|"     The objective of this study is to determine whether rifalazil can significantly increase peak     walking time (PWT) in patients with peripheral arterial disease (PAD).   "
184046|NCT00251862|"     The overall objective of this study is to conduct a three-arm randomized controlled trial to     evaluate the impact of an interactive, web-based decision aid on shared decision-making and     patient adherence to colorectal cancer (CRC) screening recommendations.   "
184080|NCT00252317|"     Abundant evidence suggests that Angiotensin Converting Enzyme (ACE) inhibition potentially     could reduce the hazardous effects of aortic stenosis and improve haemodynamics. The     treatment seems safe even in patients with severe stenosis. There are however no randomised     clinical trials that can confirm this hypothesis.   "
184047|NCT00251875|"     The study uses a randomized, prospective cohort design to assess the impact of shared online     health records on 1) patient safety, 2) health goal adherence and outcomes, 3) documentation     of family history, and 4) barriers to the adoption of patient-physician communication     technology.      Hypothesis: the respective interventions will result in 1) improved patient safety 2) greater     adherence to health care maintenance and chronic disease guidelines 3) more accurate     documentation of family history 4) the identification of technology adoption enablers and     barriers.   "
184048|NCT00251888|"     Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic     radiotherapy in patients with an advanced cervix cancer.   "
184049|NCT00251901|"     The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of     acid related pain or discomfort in the chest.   "
184050|NCT00251914|"     The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during     an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms     resolution at the end of a subsequent treatment period of 7 weeks.   "
184051|NCT00251927|"     The study investigates the efficacy of long-term treatment of esomeprazole compared to     anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to     treatment failure.   "
184052|NCT00251940|"     This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled     study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients     with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on     diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week     enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in     period, followed by a 24-week double blind treatment period and a 3-week follow-up period   "
184053|NCT00251953|"     This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled     study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to metformin in patients with     type 2 diabetes, not adequately controlled on optimized metformin treatment and on     diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week     enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in     period, followed by a 24-week double blind treatment period and a 3-week follow-up period   "
184054|NCT00251966|"     The purpose of the study is to evaluate the effect of esomeprazole 20 mg od versus placebo     for the prevention of gastric and/or duodenal ulcers in patients taking low-dose ASA.   "
184055|NCT00251979|"     This study is being carried out to see if constant 3 days infusion of Nexium is effective in     preventing rebleeding after an endoscopic treatment.   "
184056|NCT00251992|"     The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during     an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms     resolution at the end of a subsequent treatment period of 7 weeks.   "
184057|NCT00252005|"     The purpose of this clinical research study is to assess efficacy and safety of 3 doses of     apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional     treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the     treatment of subjects with acute symptomatic deep-vein thrombosis.   "
184058|NCT00252018|"     The purpose of this study is to investigate whether a daily intake of dried broccoli sprouts     will improve the endothelial function of the participants as measured by Flow mediated     dilation (FMD)      The dried sprouts are chosen because broccoli sprouts are known as containing large amounts     af the glucosinolate glucoraphanin which in vitro and in animal models has been shown to have     a positive effect on the endothelium as measured by NO release.   "
184059|NCT00252031|"     Subjects will receive a 6-month course of DBT, consisting of one 90-minute group and one     60-minute individual session per week as well as telephone availability of the individual     therapist.   "
184060|NCT00252044|"     Hypothesis: Schizotypal personality disorder patients will show cognitive improvements in 1)     working memory 2) learning and memory 3) sustained attention 4) enhanced performance on the     AX-CPT, N-back and Eriksen during pergolide treatment. There will be a significant diagnosis     by drug administration of 0.3 mg of oral pergolide interaction for performance on the     cognitive tasks, with the schizotypal personality disorder group demonstrating significantly     improved peformance compared to the other personality disorder group after pergolide compared     with placebo.      Design: Randomized, double-blind, crossover study of pergolide vs. placebo. Half of subjects     receive pergolide for eight weeks; half of subjects receive placebo for four weeks followed     by pergolide for four weeks.   "
184063|NCT00252083|"     This study will look at the following questions:        -  Was there a significant difference in HIV prevention knowledge, risk reduction          attitudes, norms, intentions, self efficacy, number of sexual partners, and incidence of          unprotected anal intercourse among seropositive Hispanic men who have sex with men (MSM)          after the implementation of ADAPT-POL?      Hypothesis: There will be a significant increase in HIV prevention knowledge, intentions, and     self efficacy concerning condom use. There will be a decrease in risk attitudes, norms,     number of sexual partners, and incidence of unprotected anal intercourse among seropositive     Hispanic MSM after the implementation of ADAPT-POL.        -  How is exposure to the intervention and intervention dosage related to the following          variables: HIV prevention knowledge, attitudes, intentions, and behaviors concerning          unprotected anal intercourse?      Hypothesis: Intervention exposure and dosage are positively correlated with improved HIV     prevention knowledge, attitudes, intentions, and behaviors concerning unprotected anal     intercourse.   "
184064|NCT00252096|"     Investigators at the University of Alabama in Birmingham in collaboration with investigators     from the Centers for Disease Control in Atlanta are evaluating the performance of three     commercial nucleic acid amplification tests for the detection of Chlamydia trachomatis and     Neisseria gonorrhoeae in pharyngeal and rectal swab specimens. Cultures for C. trachomatis     and N. gonorrhoeae are performed as additional reference tests. Study subjects are men and     women attending sexually transmitted disease (STD) and HIV care clinics in Birmingham,     Alabama, who report sexual behaviors that place them at risk for pharyngeal or rectal     sexually transmitted infections.   "
185091|NCT00268918|"     The main purpose of this study is to see if the study drug, PTK787, is safe and to find the     highest dose that can be given safely without causing serious side effects.   "
184065|NCT00252109|"     Adopting and Demonstrating the Adaptation of Prevention Techniques (ADAPT) is a supplement to     the Centers for Disease Control and Prevention (CDC) Community Based Organization Program     Announcement 04064 (PA 04064). The purpose of ADAPT is to improve the understanding of the     processes needed for adapting evidence-based behavioral interventions to fit new conditions     or populations and to pilot the CDC-developed adaptation guidance. The ADAPT project responds     to concerns from the field that existing interventions do not address the HIV prevention     needs of their specific population. This project seeks to develop guidance for agencies to     engage in the evidence-based adaptation of interventions previously shown to be effective in     evaluation settings for use in real world applications.      The New Orleans AIDS Task Force (NO/AIDS) is one of five grantees funded to use the     adaptation guidance to adapt an intervention packaged by the CDC's Replicating Effective     Programs and disseminated by CDC's Diffusion of Effective Behavioral Interventions. The     agency will adapt Jeff Kelly's Popular Opinion Leader (POL) intervention (Kelly, 2004; Kelly     et al., 1991) for use in Internet venues with seropositive men who identify     ethnically/racially as other than White/Caucasian who have sex with other men (men who have     sex with men [MSM] of color).      Kelly's POL intervention is a community-level, evidence-based HIV prevention intervention     that originally targeted gay and bisexual men in smaller cities throughout the United States.     Kelly's intervention seeks to identify and enlist the support of well-known and well-liked     opinion leaders to take on risk reduction advocacy roles. Opinion leaders attend sessions to     learn how to engage in risk reduction conversations with people in their own social networks.     The opinion leaders help to reshape social norms to encourage safer sex by helping to create     a social environment in which MSM feel comfortable and empowered to make decisions to avoid     high-risk sexual behaviors.   "
184066|NCT00252122|"     The purpose of this pilot study is to provide a preliminary assessment of the feasibility and     efficacy of intravenous ketamine in controlling pain in patients with sickle cell disease     (who are admitted to the hospital with severe, acute pain crisis, and who have been resistant     to intravenous narcotics).   "
184067|NCT00252135|"     This study is a multicenter, prospective, observational cohort study of ~5000 Xolair-treated     and ~2500 non-Xolair-treated patients with moderate to severe persistent asthma and a     positive skin test or in vitro reactivity to an aeroallergen.   "
184068|NCT00252148|"     The purpose of this study is to determine the safety of an immune response to an     investigational HIV vaccine, ADMVA, at three different dosage levels, in adults who are not     infected with HIV   "
184069|NCT00252161|"     The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant     chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and     large type 3 tumor in comparison with surgery alone.   "
184070|NCT00252174|"     This is a pilot study intended to find out if 3,4-methylenedioxymethamphetamine (MDMA) is     safe and can help people with advanced stage cancer and anxiety arising from the cancer     diagnosis.   "
184071|NCT00252187|"     The purpose of this study is to determine the effects of subcutaneous injection of Human BNP     (nesiritide), a hormone produced by the heart, on the pumping ability of the heart, kidney     function, and hormonal function in persons with heart failure.   "
184072|NCT00252200|"     Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing     heart bypass surgery.   "
184073|NCT00252213|"     This study is being done to determine the effects (good and bad) of intravenous infusion of a     human brain natriuretic peptide (BNP), Natrecor (nesiritide), a hormone produced by the heart     in persons who have just suffered a heart attack. The human BNP, Natrecor (nesiritide) has     been approved by the United States Food and Drug Administration (FDA) to be given     intravenously for the management of acute heart failure. It is unknown if human BNP may have     good effects on the pumping function of the heart after a heart attack.   "
184074|NCT00252226|"     This is a single center, open prospective study to evaluate the effectiveness of quetiapine     monotherapy in the maintenance treatment of adolescent patients with a bipolar spectrum     disorder (bipolar I and bipolar II disorders, cyclothymia, and bipolar disorder not otherwise     specified [bipolar NOS]) for a minimum of 48 weeks. Patients will be screened (enrolment     phase) either when already stabilized or during an acute episode of mania/hypomania or     depression.   "
184075|NCT00252239|"     The purpose of this study is to determine which of 3 different doses of tenecteplase (TNK) is     better for treating stroke patients and if TNK offers an advantage over currently available     treatment with tissue plasminogen activator (tPA).   "
184076|NCT00252252|"     The aim of the study is to compare the effects of a modified form (AutoVPAP) of the VPAP     non-invasive ventilator versus standard VPAP ventilation on sleep quality and breathing     during sleep in stable patients with nocturnal hypoventilation due to restrictive ventilatory     disorders (eg. neuromuscular disease or chest wall disorder).   "
184089|NCT00252434|"     The purpose of this study is to evaluate whether a specially developed group counseling     approach is better able to help HIV-positive gay and bisexual men (GBM) who use crystal meth     to stop using methamphetamines, reduce sexual risk behaviors, and stay on their HIV     medications than a standard drug treatment program. Another purpose is to determine whether     having a drug abuse treatment program in an HIV medical clinic makes it easier to attend     treatment than going to a separate location for drug abuse treatment.   "
184077|NCT00252278|"     Children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) very commonly     experience difficulty in initiating and maintaining sleep. Studies have shown that daytime     sleepiness resulting from insufficient sleep can affect attention and learning. Therefore,     treating insomnia in children with ADHD may not only improve sleep, but it could potentially     improve ADHD symptoms as well.      The main purpose of this study is to examine the effects of atomoxetine on ADHD-related     insomnia. Atomoxetine (Strattera®) is a non-stimulant drug used to treat ADHD symptoms in     both children and adults, and there is evidence that it may also have a positive effect on     sleep in children with ADHD. During the study, participants will receive either atomoxetine     or placebo for a period of four weeks. We expect that the effects of atomoxetine on sleep     will differ from those of placebo, with atomoxetine having a greater effect on improving     sleep difficulties.   "
184078|NCT00252291|"     This is a Phase 3 study to determine the sensitivity and specificity of the Aridol bronchial     challenge test to detect bronchial hyperresponsiveness in patients with suspected asthma.     Patients with suspected asthma of either gender, aged between 6 and 50 years, with only     mildly impaired lung function (FEV1 >70%) are to be tested with three different bronchial     hyperresponsiveness challenges (Aridol, exercise and methacholine), and the results compared.     A clinical diagnosis will also be made at the end of the study.   "
184079|NCT00252304|"     The aim of this study is to assess whether zinc given as adjuvant therapy to standard     antibiotic treatment in children hospitalized for severe pneumonia reduces the duration of     the severe illness and risk of treatment failure. A randomized double blind placebo     controlled clinical trial will be conducted at the Kanti Hospital.   "
184082|NCT00252343|"     To evaluate the efficacy of a fixed dose of SR58611A (350mg q12) compared to placebo in     patients with GeneralizedAnxiety Disorder (GAD) using escitalopram (10 mg qd) as positive     control. To evaluate the tolerability and safety of SR58611A in patients with GAD.   "
184083|NCT00252356|"     To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in     patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive     control. The study is a multicenter, US and Canadian, randomized, double-blind,     3-parallel-group, placebo- and escitalopram-controlled, Phase III study consisting of four     segments (A, B, C and D). Segment A is a 1-week, placebo, single-blind period. Segment B is     an 8-week, double-blind period. Segment C is an optional 18-week double-blind extension     period. Segment D is a 1-week safety follow-up period after study drug discontinuation or     early termination (during Segment B or C).   "
184084|NCT00252369|"     This study is aimed to assess the hypothesis that instillation of fibrin glue with the     induction of local conditions using Infliximab, may be useful in the treatment of perianal     Crohn's disease.   "
184085|NCT00252382|"     The purpose of this study is to evaluate the objective tumor response rate (based on the     RECIST criteria) to SNS-595 as a second-line therapy in patients with advanced NSCLC.   "
184086|NCT00252395|"     All reliably evaluated POE systems to date have been desktop computer based, but now there is     widespread use and acceptance among physicians of PDA devices for a variety of purposes.     Clinicians report that drug information on a PDA improved their access to information and     efficiency while reducing their self perceived error rates6. The use of these devices for     information retrieval in clinical settings is expected to grow as wireless communication     becomes more ubiquitous and as more applications become available6,7. During the past decade     there has been a growing awareness of several issues aimed at promoting safer health care for     our patients – point of care information technology is one of the keys.      To this end we have worked with a Canadian company, Drugmagnet, to develop and implement     PDA-based electronic prescribing system within a major Canadian academic health centre. This     is a cluster randomised trial, in which access to and use of the e-prescribing system is     switched on and off for randomly chosen weeks, thus time serves as the randomized element.   "
184087|NCT00252408|"     Hypothesis: Use of hormone replacement therapy (HRT) decreases the incidence of fractures in     early postmenopausal women.      The project was initiated in 1990, and the inclusion ended in 1993. A total of 2,016 early     postmenopausal women were divided into two groups: The first group accepted randomisation to     HRT or not, and the second group was allowed to choose HRT or not.      The study was not blinded. Main measurements were fracture risk over 20 years, changes in     bone mineral density over 20 years, and side effects, mainly breast cancer.   "
184088|NCT00252421|"     Osteoporosis or thinning of the bones affects in 1 in 4 Canadian women and 1 in 8 Canadian     men. Moreover, while the rates of osteoporosis among Canadians are stabilizing, worldwide the     number of people afflicted with osteoporosis continues to rise. The most serious complication     of osteoporosis is a broken bone or fracture. Fractures due to osteoporosis can result in     long hospital stays, dependence on others, and premature death. While there are several     medications that prevent osteoporosis they all have side effects. For example, postmenopausal     women who take hormone replacement therapy (HRT) are at increased risk of breast cancer and     heart disease. In addition, drugs to prevent osteoporosis are expensive and not available     worldwide. Therefore, it is essential that researchers continue to identify and test new     medications for the prevention of osteoporosis.      The purpose of the research is to determine if nitrates, a group of drugs that are widely     available, inexpensive, and commonly used to treat chest pain or angina, can prevent     osteoporosis in women. If the researchers find that nitrates prevent osteoporosis, a widely     available, inexpensive treatment for osteoporosis prevention that does not have any long term     side effects would have been identified. This will improve the health of patients with     osteoporosis worldwide.   "
184237|NCT00253877|"     This study compares outcomes and metal ion levels between patients who receive the Conserve®     Plus Hip System compared to those who have received a standard hip replacement in a recent     study.   "
184090|NCT00252447|"     Radical prostatectomy and radical radiation therapy remain the standard treatment approaches     for patients with clinically localized prostate cancer (T1, T2).Radical prostatectomy is most     effective when the disease is organ confined at the time of surgery. However, in many series     up to 60% of patients have positive resection margins at the time of surgery and there is     evidence to suggest that these patients may not be curable by surgery alone. A number of     preoperative clinical variables including clinical stage, serum Prostate Specific Antigen     (PSA) and Gleason scorea re helpful in determining the probability of finding organ confined     disease at the time of syrgery.   "
184091|NCT00252460|"     The target volume in prostate cancer radiotherapy typically consists of the entire prostate     gland which is localized by contours drawn on axial computed tomography (CT) radiation     planning images. Compared with CT, magnetic resonance (MR) can provide better definition of     the prostate gland with respect to the surrounding tissues and the use of multi-plannar     reconstruction avoids the problem of partial volume averaging inherent in CT. CT has been     shown to significantly overestimate the volume of the gland using the MR-defined prostate     volume as the gold standard. Co-registration of MR and CT datasets, matched on fixed bony     landmarks, has enabled radiation planning using a MR-defined clinical target volumes,     combined with CT-based electron density information necessary for radiation treatment     planning.      Rationale and Hypothesis:      Co-registration may allow better delineation of tumour volumes in prostate cancer. This     investigation is a fesibility study designed to evaluate and optimize imaging parameters and     co-registration techniques for CT planning and MRI Simulator.   "
184092|NCT00252473|"     Immobilization devices such as thermoplastic masks are used routinely in the radiation     treatment of head and neck cancer patients. It is important to assess how well they function     at preventing patient motion while the radiation treatment is being delivered. (i.e.     isocentre set-up margins, patient motion with the mask). If these new thermoplastic masks     such as MedTec S-frame allow less movement, then smaller margins are needed during radiation     therapy which, in turn, would decrease side effects from the treatment.   "
184210|NCT00253149|"     The purpose of the study is to evaluate the effectiveness and safety of risperidone (an     antipsychotic medication) versus placebo as add-on therapy to mood stabilizers in the     treatment of manic episodes associated with bipolar disorder.   "
184093|NCT00252486|"     The purpose of this study is to test the hypothesis that flax oil, as an omega-3 fatty acid,     will be superior to placebo in the maintenance treatment of bipolar disorder in children and     adolescents.      Our primary objective was to determine if flax oil is efficacious in the pediatric bipolar     population for reducing symptoms of mania and depression. A secondary objective was to     examine fatty acid levels as predictors of treatment response and symptom severity. This     clinical trial evaluated whether supplementation with flax oil, containing the omega-3 fatty     acid alpha-linolenic acid (alpha-LNA), safely reduced symptom severity in youth with bipolar     disorder.   "
184094|NCT00252499|"     The purpose of this study is to determine whether nonalcoholic fatty liver disease (NAFLD) is     associated with altered peripheral and hepatic insulin sensitivity and to investigate     potential mechanisms underlying insulin resistance in NAFLD by determining associations     between hepatic and peripheral insulin sensitivity, hepatic steatosis, dyslipidemia,     inflammatory cytokines, glucose metabolism, beta-cell function and body fat distribution.   "
184095|NCT00252512|"     Contingency management interventions involve providing a tangible reward for progress toward     treatment goals. The purpose of this study is to determine whether a contingency management     intervention added to usual care leads to improved attendance and decreased substance use in     patients attending outpatient substance use disorders treatment.   "
184096|NCT00252525|"     CSP 465-B, Correlation of Plasma Endothelial Cell (Basic Fibroblast Growth Factor) Activity     With Cardiovascular Events in Patients with Diabetes Mellitus, Type II.      Mark Zimering M.D.      Objectives: Endothelial cell dysfunction plays a role in the development of the     atherosclerotic vascular lesion and it is also thought to provide a mechanism for increased     urinary albumin excretion in type 2 diabetes mellitus. Micro- or macroalbuminuria are     associated with increased cardiovascular (CV) morbidity and mortality in type 2 diabetes     mellitus. In at least one longitudinal study in older-age onset patients, micro-or     macroalbuminuria robustly predicted increased CV risk independent of other diabetes-related     factors.1 The pathogenetic mechanisms underlying a significant association between micro- or     macroalbuminuria and CV risk in diabetes mellitus are not known but may include: growth     factors, clotting factors, lipids, or hemodynamic factors. The aim of the present study is to     investigate whether an angiogenic growth factor, basic fibroblast growth factor (bFGF), plays     a role in increased CV risk in type 2 diabetes mellitus. Research Plan: BFGF (FGF-2) is one     of the most potent known angiogenesis factors. Increased bFGF was previously associated with     both endothelial cell injury and micro- or macroalbuminuria. In a prior study of 73 older-age     onset veterans with type 2 diabetes mellitus (JCEM, 1996), we found plasma endothelial cell     (bFGF) activity was significantly associated with glycemic levels, and (in multiple     regression analysis) independently associated with both microalbuminuria and retinopathy. We     will test whether plasma endothelial cell (bFGF) activity is significantly, independently     associated with a pooled endpoint of cardiovascular events that includes myocardial     infarction (MI), coronary revascularization, congestive heart failure (CHF), or CV mortality.     We expect that increased bFGF may itself be a robust marker for increased CV risk in diabetes     mellitus for three reasons. First, because bFGF was independently associated with     (micro)-albuminuria in type 2 diabetes mellitus. Second, because increased bFGF was     associated with increased activity in the renin-angiotensin system in vascular smooth muscle     cells (Dzau, et al. JCI, 1995). And third, because (as we reported) angiotensin converting     enzyme inhibitor (ACEi) drugs substantially decreased plasma bFGF levels in (micro)-     albuminuric diabetes mellitus type 2, and (as others reported) ACEi drugs substantially     reduced the risk of development of CHF in patients with LVH 2, the risk of mortality after MI     (8,9), and the risk of CV death in diabetic patients with proteinuria.      Because plasma endothelial cell (bFGF) activity correlated significantly with glycemic levels     in diabetes mellitus type 2, plasma bFGF may be one of the pathogenetic links between     glycemic levels and an increased risk of cardiovascular events in diabetes mellitus, type 2.      Methods: Blood (3 mL EDTA plasma) will be collected from each subject in Years 1, and 2 of     the Study at each of 6 local participating VA substudy sites. Because plasma endothelial cell     (bFGF-like) bioactivity and bFGFR-IR in vivo are stable for months and years based on our     prior published studies (1-3), we anticipate that obtaining 2 specimens, 1 each in Years 1, 2     of the study, will provide sufficient data to model proportional risk.   "
184097|NCT00252538|"     The purpose of this study is to identify predictors and associated biochemical markers of     interferon-induced depression. It is hypothesized that genetic variation in genes related to     the serotonergic system may predict vulnerability to interferon-induced depression.   "
184098|NCT00252551|"     Study to evaluate the superiority of the osteosynthesis associated with a decompressive     surgery in comparison with a simple decompressive surgery in the treatment of lumbar     degenerative stenosis with spondylolisthesis   "
184099|NCT00252564|"     The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12     months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first     line treatment of metastatic colorectal cancer.   "
184100|NCT00252577|"     The purpose of this study is to identify genetic predictors of lithium response in bipolar     disorder.   "
184101|NCT00252590|"     The purpose of this study is to determine whether a health focused motivational intervention     will reduce alcohol use for dependent veterans who are receiving outpatient alcohol and drug     treatment.   "
184102|NCT00252603|"     Autism is a severe neurodevelopmental disorder that affects up to 16 in 10,000 individuals.     It is a pervasive developmental disorder affecting social, communicative, and     compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements,     craving for sameness, and narrow repetitive interests. Autism severely impacts both the     affected individual and family members.      The proposed study is designed to assess the efficacy of treatment with Galantamine vs.     placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview     (ADI) criteria. We therefore hypothesize:        1. Galantamine will be superior to placebo in the acute treatment of global autism.        2. Galantamine will be superior to placebo in improving functional ability.        3. Galantamine will be superior to placebo in improving language function.        4. Galantamine will be superior to placebo improving irritable and hyperactive behavior.        5. Galantamine will be superior to placebo in improving social deficits.   "
184103|NCT00252616|"     This study tests the hypothesis that initial trophic enteral feedings will increase the time     alive and free of mechanical ventilation as compared to initial goal enteral feedings in     patients who are mechanically ventilated.   "
184118|NCT00252811|"     This is a Phase II, randomised, double-blind, placebo-controlled study. Subjects with     histologically-confirmed oestrogen receptor negative (ER-), progesterone receptor negative     (PgR-) primary breast cancer breast cancer will be randomly assigned in a 2:1 ratio to     receive ZD1839 250 mg once daily or matching placebo for a total period of 5 weeks. Surgical     intervention will take place after 4 weeks (on Day 29) and treatment will continue for 1 week     after surgery.   "
184119|NCT00252824|"     The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with     conventional stepwise treatment according to asthma treatment guidelines in patients with     persistent asthma   "
184104|NCT00252629|"     The purpose of this study is to determine any sleep disordered breathing in veterans with     Gulf War Syndrome (GWS) and compare it to healthy normal asymptomatic Gulf War veterans. This     study will also determine the effect of treatment with continuous positive airway pressure on     veterans with Gulf War Syndrome.        1. The investigators hypothesize that sleep complaints (insomnia, un-refreshing sleep and          daytime fatigue) among GWS patients are related to increased sleep fragmentation          secondary to the presence of sleep disordered breathing in GWS patients.        2. The investigators hypothesize that increased collapsibility of the upper airway during          sleep with the development of inspiratory flow limitation (IFL) and sleep disordered          breathing causes the increased sleep fragmentation in GWS patients.        3. The investigators hypothesize that correction of IFL and sleep disordered breathing in          GWS patients will result in an improvement of their sleep quality resulting in an          improvement of their sleep complaints and other functional symptoms.   "
184105|NCT00252642|"     The primary purpose of this study is to determine if peginterferon alpha-2a maintenance     therapy (90 mcg/week) will lower portal pressure in patients with hepatitis C virus     infections and advanced fibrosis or cirrhosis.   "
184106|NCT00252655|"     The purpose of this study is to evaluate the efficacy of Sirolimus (Rapamune) in improving     the function of the transplant kidney, without any increase in the risk of acute rejection or     adverse side effects, compared with Tacrolimus (Prograf).      We hypothesize that Sirolimus, as one component of a long-term steroid-free immunosuppressive     regimen, will be effective in maintaining a low incidence of acute rejection and a short- and     long-term graft survival comparable to Tacrolimus with better graft function in the high-risk     African-American renal transplant population with immediate graft function.   "
184107|NCT00252668|"     This study is an open label extension of a previously completed double-blind, randomized     study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All     subjects will receive combination treatment with etanercept and methotrexate.   "
184109|NCT00252694|"     The primary objective is to determine whether candesartan, compared to placebo reduces the     progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with     retinopathy.      The secondary objective is to determine whether candesartan, compared to placebo, reduces the     incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic     retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion     rate (UAER).      This study is part of the DIRECT Programme also including a primary prevention study of     diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes.     The primary objective for all three pooled studies is to determine whether candesartan,     compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic     patients.   "
184110|NCT00252707|"     In this study, among the patients with non-small cell lung cancer, those with metastasis or     recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and     we will compare the effectiveness and safety of gefitinib with docetaxel.   "
184111|NCT00252720|"     The primary objective is to determine whether candesartan, compared to placebo reduces the     progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic     patients with retinopathy.      The secondary objective is to determine whether candesartan, compared to placebo, reduces the     incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic     retinopathy (PDR) and beneficially influences the rate of change in urinary albumin excretion     rate (UAER).      This study is part of the DIRECT Programme also including a primary prevention study of     diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 2 diabetes.     The primary objective for all three pooled studies is to determine whether candesartan,     compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic     patients.   "
184112|NCT00252733|"     The primary objective is to determine whether candesartan, compared to placebo reduces the     incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients     without retinopathy.      The secondary objective is to determine whether candesartan, compared to placebo,     beneficially influences the rate of change in urinary albumin excretion rate (UAER).      This study is part of the DIRECT Programme also including secondary prevention studies of     diabetic retinopathy in both type 1 and type 2 diabetes. The primary objective for all three     pooled studies is to determine whether candesartan, compared to placebo, reduces the     incidence of microalbuminuria in type 1 and type 2 diabetic patients.   "
184113|NCT00252746|"     To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day     respectively   "
184114|NCT00252759|"     The purposes of this study are:        -  To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with          gefitinib as compared to other chemotherapy treatment, and to assess the risk factors          for ILD in advanced/recurrence NSCLC patients undergoing treatment        -  To provide an estimate of the incidence of ILD in a group of advanced/recurrence NSCLC          patients undergoing treatment   "
184115|NCT00252772|"     This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled     study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately     controlled on diet and lifestyle advice alone during the run-in period. The study comprises a     6-week single-blind placebo run-in period followed by 24-week treatment period and a 3-week     follow-up period.      The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT     2 will be transferred to the GALLANT 22 database and will be analyzed together with the data     from GALLANT 22 clinical study.   "
184116|NCT00252785|"     The primary objective of this study is to confirm the efficacy (superiority) of Symbicort®     Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg     twice daily + Theolong® tablet 200 mg twice daily.   "
184117|NCT00252798|"     The primary objective of the trial is to determine the Maximum tolerated dose, if any, of the     combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up     to 45 mg/m2 paclitaxel.   "
186089|NCT00282841|"     The purpose of this study is to find out more about the usefulness of ultrasound in     combination with a contrast solution to look for blood vessel blockage or occlusion in the     brains of stroke patients.   "
184120|NCT00252837|"     This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled     study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately     controlled on diet and lifestyle advice alone during the run-in period. The study comprises a     6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week     follow-up period.      The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT     2 will be transferred to the GALLANT 22 database and will be analyzed together with the data     from GALLANT 22 clinical study.   "
184121|NCT00252850|"     This is a Phase I dose escalating open-label study designed to assess the safety,     tolerability and biologic activity of an in vivo AAV2 mediated delivery of the gene encoding     NTN (CERE-120).      Twelve (up to 18) subjects will receive one of two open-label doses of CERE-120 via bilateral     stereotactic injections targeting the putaminal region of the brain. Subjects will be     enrolled in one of two cohorts, a low-dose cohort of six subjects followed by a high dose     cohort of six subjects.      The design of this study is such that the primary objective, the evaluation of safety and     tolerability, will be assessed by frequent observations for adverse events, clinical     laboratory test results, imaging (MRI), neuropsychometric testing, and evaluations of disease     status.   "
184122|NCT00252863|"     The purpose of this study is to determine whether Symbicort dosed according to the Symbicort     Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment     according to the local German treatment guidelines.   "
184123|NCT00252876|"     This is a 107-week open-label, multi-center long-term extension study from GALLANT studies     2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in     patients with type 2 diabetes during up to 104 weeks of treatment. The total duration,     including treatment and follow-up, is 107 weeks.   "
184124|NCT00252889|"     The primary objective is to determine the nature and degree of the toxicity of weekly dosing     of topotecan in escalating dose levels by cohorts of 3-6 patients in combination with a fixed     dose of pegylated liposomal doxorubicin (Doxil).      The secondary objective is to determine the activity of weekly topotecan and pegylated     liposomal doxorubicin in advanced solid tumors.   "
184125|NCT00252902|"     The primary purpose of the study is to refine the intervention protocols for two ED-initiated     tobacco interventions and to assess the magnitude of the effect size that can be expected. We     expect the intervention groups to have greater sustained abstinence, point-prevalence     abstinence, and motivation to change when compared to the treatment as usual group at 1- and     3-month follow-up.   "
184126|NCT00252915|"     There is basic science evidence that GM-CSF reconstructs cellular immunity in septic     patients. In this prospective, randomised double-blind, placebo-controlled trial, we     investigate whether this can be achieved in patients with severe sepsis and septic shock.   "
184127|NCT00252928|"     The purpose of this study to determine whether Aquatabs, a water treatment tablet, reduces     diarrheal diseases in a peri-urban population of Tamale, Ghana.   "
184128|NCT00252941|"     The purpose of this study is to determine the feasibility, safety, and efficacy of the     Memokath® 028SW stent to prevent urinary obstructive symptoms (difficulty urinating) when     used after prostate seed implantation for the treatment of localized prostate cancer.   "
184129|NCT00252954|"     Purpose: To evaluate the efficacy and safety of levetiracetam on chronic neuropathic pain     after spinal cord injury, and to examine its effect on spasms and evoked pain.   "
184130|NCT00252967|"     The purpose of this study is to test whether the drug, atorvastatin, will be able to reduce     the rate of return of the abnormal beats after using cardioversion. Atorvastatin is a drug     approved by the Food and Drug Administration (FDA) for the treatment of high cholesterol but     is not approved for preventing abnormal heartbeats. In addition to lowering cholesterol, the     drug reduces inflammation. Inflammation seems to help cause atrial fibrillation, a certain     type of abnormal heartbeat. In animals, atorvastatin reduces the risk of this type of     abnormal beats, and preliminary data in humans supports an effect of atorvastatin and other     similar drugs that have the same action on reducing the risk of this type of abnormal beats.     We, the researchers at Emory University, would like to learn if this drug could prevent the     return of these abnormal heartbeats.   "
184131|NCT00252980|"     The purpose of this study is to develop a modular treatment program for cannabis use     disorders and the evaluation of the effectiveness in a controlled clinical study.   "
184132|NCT00252993|"     This is a randomized, double blind, placebo controlled, multicenter study designed to assess     the safety and efficacy of DDP225 in patients with chronic functional vomiting. Male or     female patients from 18 to 65 years of age with a functional vomiting history for at least 12     weeks in the preceding 12 months or cyclic vomiting history with at least 3 episodes in the     previous 12 months are eligible. A total of 30 eligible patients with chronic functional     vomiting will be enrolled.      The total duration of study participation for an individual patient is approximately 15 weeks     (105 days) from the initial screening visit to final study evaluations. The total duration of     dosing with study medication (either DDP225 or placebo) is 12 weeks.      Patients who satisfy all of the inclusion criteria and none of the exclusion criteria are     eligible to enter the Treatment Period and will be randomly assigned to one of three     treatment groups.      After a patient is randomized and enters the Treatment Period, he/she will take the     appropriate study medication once a day for 84 days and return to the clinic at two week     intervals for a total of six visits during the Treatment Period. During the Treatment Period,     patients will maintain a daily diary and complete questionnaires. One week after completing     the 84-day Treatment Period, patients return to the clinic for final safety evaluations which     include a physical examination, electrocardiogram, and clinical laboratory testing.   "
184133|NCT00253006|"     Painful bladder syndrome (PBS)/interstitial cystitis (IC) may be due to the actions of nitric     oxide (NO) in the bladder tissue. NO is a gaseous substance with a very short half-life,     synthesized by a group of NO-synthase-enzymes in many tissues.      The goal of this study is to illuminate bladder tissue production of NO in individuals with     PBS and healthy individuals, by quantification of NO and NO-enzyme expression by different     molecular biological methods.   "
184134|NCT00253019|"     This study will assess the continuation rates among women using oral contraceptive pills,     Depo-Provera and Ortho Evra following a first trimester abortion.   "
186090|NCT00282854|"     The purpose of this study is to find the genes that cause Rolandic epilepsy and its related     traits.   "
184135|NCT00246701|"     The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters)     [formerly known as Omacor] combined with simvastatin for lowering non-high-density     lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite     statin therapy.      Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.   "
184136|NCT00246714|"     A number of diseases lead to a so called systemic inflammatory response syndrome (SIRS). This     excessive response is self-destructive and leads to major complications of the initial     disease: dysfunction of the microcirculation, systemic vasodilation, and increased capillary     leakage and oedema. Animal studies have shown that pre-treatment with endotoxin     (lipopolysaccharide or LPS) suppress the excessive immune response and when rechallenged, the     animal survive a normally lethal dose of endotoxin.      Besides a diminished cytokine response, an increased production of leucocytes in the bone     marrow and an increased phagocytosis after pre-treatment with endotoxin is seen. The     combination of these factors: diminished systemic inflammatory response and increased     cellular immunity makes that endotoxin tolerance is a useful tool for preventing the     complications after an excessive inflammatory response.      Further, the presence of cross-tolerance has also been shown: Endotoxin tolerant mice survive     more after induction of a normally lethal fungal infection. Endotoxin tolerance is also     protective for ischemia/reperfusion injury in kidneys, heart and liver. Little data is known     about endotoxin tolerance in human.      The purpose of this study is to induce a state of tolerance through 2 different     administration schedules and monitor the effect of tolerance on pro- and anti-inflammatory     cytokines, other inflammatory parameters and different proteins involved in the signalling     pathway. The effects of tolerance on vascular reactivity will be determined. Finally, the     effect of tolerance on ischemia-reperfusion injury will be investigated.   "
184162|NCT00247052|"     The aim of the sudy is to evaluate, through clinical, biological and transthoracic     echocardiography follow up, the evolution of post operative (cardiac surgery) pericardial     effusion and mostly to evaluate the efficiency of a non steroidal anti inflammatory (NSAID)     drug (diclofenac)for this indication.   "
184137|NCT00246727|"     The primary objective of these two studies is to test the hypothesis that the daily ingestion     of a dietary supplement, Selected Vegetables and Herbs Mix (SV), which consists of non-toxic     botanicals containing known anti-cancer and/or immune enhancing components, may prolong the     survival time of stage IIIB/IV non-small cell lung cancer (NSCLC) patients. Either SV or     placebo will be added to their daily diet in a double-blind randomized fashion, so that there     will be 2 chances out of 3 of receiving SV and 1 chance out of 3 of receiving placebo.        -  Study 1: For newly diagnosed patients who will be receiving or have received less than 4          weeks of, a standard chemotherapy regimen.        -  Study 2: For those who have stopped or refuse standard chemotherapy but will receive          best supportive care.   "
184138|NCT00246740|"     The purpose of this study is to determine whether doxycycline(Periostat)at a     sub-antimicrobial dose will decrease reperfusion injury after coronary artery bypass grafting     (CABG) surgery with cardiopulmonary bypass (CPB).   "
184139|NCT00246753|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with     prostate cancer that did not respond to hormone therapy.   "
184140|NCT00246766|"     To enable an investigation of fetal movements, the researchers have developed a multichannel     ultrasound pulsed Doppler called ACTIFOETUS. This new fetal monitor includes three     transducers of four sensors which are placed on three different zones of the mother's     abdomen. One of the transducers is aimed at the fetal heart, another at the lower limbs and     one transducer at the thorax and the fetal upper limbs to detect heart and body movements.     The signals are analysed and processed by software which computes a number of parameters     describing the movements.      Ninety pregnant women from 28 weeks gestation will be monitored over a 40 minute period every     month or every 2 weeks in case of pathological pregnancy. The final purpose will be to     develop a system of home monitoring as an indicator of fetal well-being.   "
184141|NCT00246779|"     Cardiac surgery is a major consumer of blood products worldwide. The nature of the surgery     when the heart-lung machine is used, is such that the patient's blood is significantly     diluted by intravenous fluids. This dilution further compounds the blood's ability to form     blood clots to seal the wound, thus increasing bleeding after surgery. The problem of this     dilution is particularly severe in patients with low body weight, of whom a large percentage     are women undergoing heart surgery. As a result, in this population there is an increased     risk of needing a blood transfusion during and after surgery. The effects of this dilution     can be potentially reversed by filtering the blood and removing the fluid after the principal     part of the procedure has been completed through a process referred to as modified     ultrafiltration (MUF). This procedure has been shown to be effective in several small     clinical studies, however the interpretation of the results has been complicated by the fact     that the studies were not blinded. In other words, because the physicians and surgeons     making the decisions about blood transfusions knew what treatment the patients received (i.e.     MUF or not) it may have biased their judgement and affected the validity of the findings of     the studies. The investigators believe that MUF may be a useful procedure to limit blood     transfusions, particularly in patients of low body size, and weight undergoing heart surgery.     This can only be demonstrated in a large clinical trial, and in the best case scenario, in a     trial in which total blinding has been undertaken. However, blinding in this manner is quite     difficult to achieve and it is necessary first to demonstrate that this is possible. Further,     as the trial will involve several heart centers, it is essential to demonstrate that the     relatively complex study interventions can be carried out in each of the centers in a     reproducible manner. With this data in hand, the investigators will be able to submit for     funding at a later date for a very large trial to determine if MUF decreases the need for     blood transfusions in heart surgery patients. The investigators will also be able to     determine the effect of this in terms of helping conserve blood as a benefit to the     blood-banking agency (the Canadian Blood Service).   "
184142|NCT00246792|"     Research and intervention programs for students with learning disabilities (LD) typically     address child and family characteristics without examining the school context and conditions     that affect adjustment. Focusing on the student with LD can highlight the child and family’s     deficits. An ecological theoretical framework guides this research project, a collaboration     of the University of Toronto, Faculty of Social Work and Ontario Institute for Studies in     Education of the University of Toronto (OISE/UT), Integra and the Toronto Catholic District     School Board. This framework is based on the assumption that people are very much part of and     affected by social and environmental settings. Accordingly, it is important not to see the     adjustment problems of children with LD as being caused only by their LD. Instead, their     academic and social problems are seen as unfolding in larger circumstances that include other     children, the classroom, the school, the family and the community. These many factors act     together to influence the child with LD and must be taken into account along with individual     characteristics of the child.   "
184143|NCT00246805|"     The purpose of this study is to monitor heart rate regularization in patients with permanent     atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).   "
186091|NCT00282867|"     The purpose of this study is to assess the feasibility, safety and preliminary efficacy of     the use of insulin infusions as treatment for hyperglycemic acute ischemic stroke patients.   "
184144|NCT00246818|"     This study will compare the effectiveness of Tai Chi (a sequence of slow, graceful body     movements) and a cardiovascular exercise fitness program in improving physical fitness and     endurance, reducing stress and improving well-being in adult survivors of cancer. Tai Chi,     described by some as a moving form of yoga and meditation combined, evolved from martial arts     and breathing exercises in China hundreds of years ago. This study uses the 24-posture     standardized Tai Chi. The movements are continuous, smooth, and natural, with the upper and     lower parts of the body following each other. The entire body is always in motion, with the     movements performed gently and at a uniform speed. The exercise training program uses an     exercise machine. The training regimen is adjusted to maintain the individual's average     training heart rate at 70 to 80 percent heart rate reserve; i.e., 220 minus the person's age.      Cancer survivors of solid tumor cancers who are between 18 and 65 years of age, whose     treatment included chemotherapy, biologic agents or vaccines, who have had no cancer     treatment for at least 24 months, and who have had no evaluable disease within 3 months of     screening for this study may be eligible to participate.      Participants are randomly assigned to one of three study groups: Tai Chi, exercise training,     or a waiting list. Individuals in the Tai Chi and exercise training groups participate in a     supervised program for 1 hour 3 times a week for 12 weeks in the NIH Clinical Center's     Rehabilitation Medicine department. Individuals assigned to the waiting list are followed for     12 weeks during the waiting period and are then assigned to either the Tai Chi or exercise     program for another 12 weeks as described above.      At three time points during the study-before starting the program and after 6 weeks and 12     weeks of practicing the study intervention or being on the waiting list-participants undergo     the following procedures:      Complete questionnaires regarding their quality of life and stress      Rehabilitation medicine evaluation, including the following:        -  Questions about managing their daily activities, whether their skills have changed over          time, what they may or may not have been able to do, or what they may have had to          overcome as a result of their previous illness and the study program they have been          practicing        -  Measurements of strength and mobility        -  Evaluation of overall physical fitness and endurance        -  Blood tests to measure blood cell counts and cholesterol, lipid, hormone and mineral          levels   "
184189|NCT00247416|"     The purpose of this study is to find better treatment for lung cancer and to find out what     effects the combined treatment of carboplatin and gemcitabine when given with or without     dexamethasone have on cancer.      This study will determine if dexamethasone, when given before standard chemotherapy will     increase the cancer fighting effects and reduce the side effects of chemotherapy.   "
184145|NCT00246831|"     This study will examine how people consider their actions to be under their own control or     not. The term to describe this feeling of being in control of one's own actions is called     agency. The sense of agency becomes impaired in disorders such as schizophrenia, in which     people may feel, for example, as if someone else is controlling their thoughts.      Healthy, right-handed normal volunteers 18 years of age and older may be eligible for this     study. Candidates are screened with a medical history, neurological examination, pregnancy     test for women of childbearing age, and magnetic resonance imaging (MRI) scan. MRI uses a     strong magnetic field and radio waves to obtain images of body organs and tissues. During the     procedure, the subject lies on a table that can slide in and out of the scanner (a metal     cylinder surrounded by a magnetic field) and may be asked to lie still for up to 30 minutes     at a time.      Participants undergo functional MRI (fMRI). This procedure is the same as a regular MRI,     except it is done while the subject performs tasks. This enables researchers to learn about     changes in brain regions involved in those tasks. The fMRI scan for this study takes about 90     minutes.      Before beginning the fMRI procedure, subjects receive training using a Cyber glove device.     This device allows the researchers to measure the subject's finger movements and display them     on a screen for the subject to view. The subjects are asked to make hand movements by slowly     opening and closing the hand while watching the computer displaying an artificial hand.     During the movements, the subjects' level of control is adjusted and they are asked to     describe how much control they think they have over the hand on the screen. When the subjects     become comfortable using the Cyber glove, they enter the MRI scanner to begin the test scan.      For the fMRI, subjects are given visual instruction on when to begin opening and closing     their right hand. They move continuously for a 30-second block and then have a 20-second rest     period. This is repeated, with subjects provided different levels of control over the     displayed hand in each block. The entire test consists of four runs, each run consisting of     12 blocks lasting about 10 minutes. When the fMRI scanning is finished, the brain is scanned     once more using regular MRI.   "
184146|NCT00246844|"     This study will examine whether insulin-producing cells in the pancreas (beta cells) can     recover in patients with type 1 diabetes who have had a pancreas transplant. In type 1     diabetes, the body's immune system destroys the beta cells. Patients are treated with insulin     shots or a pancreas transplant to control their blood sugar. Some experiments suggest that     the pancreas may have the capacity to recover some of its insulin-producing capacity, but     that ability is negated by factors such as the continuing immune attack and erratic blood     sugar levels in patients.      Patients who have had a pancreas transplant may be in a unique situation to allow their own     pancreas to regrow beta cells for two reasons: 1) the medicines they take to prevent     rejection of the transplanted pancreas weaken their immune system; and 2) they have     near-normal blood sugar levels because of their functioning transplanted pancreas. This study     will test this hypothesis by sampling blood from patients' hepatic vein, which drains the     liver and native pancreas and from their iliac vein, which drains the transplanted pancreas.     This will determine whether insulin is coming from the transplanted pancreas (iliac vein) or     the liver and native pancreas (hepatic vein).      Patients 18 years of age and older who have had stable pancreatic transplant function for     more than 5 years may be eligible for this study. Candidates are screened with a medical     history and physical examination.      Participants are admitted to the hospital for 2 days for a full medical examination, blood     tests and procedures to determine insulin production. The procedures will include the     placement of catheters in the neck and groin for blood sampling. Participants will be closely     monitored after the procedures and discharged home if there are no complications.   "
184147|NCT00246857|"     This study will determine the biochemical and genetic causes of inherited immune diseases     affecting lymphocyte homeostasis. Lymphocytes are a type of white blood cell that fights     infections. Normally, the body keeps a precise balance in which lymphocyte growth is matched     by lymphocyte death. People with constantly enlarged lymph nodes or spleen, along with     autoimmune disease, immunodeficiency, lymphoma, or other immune problems affecting     lymphocytes may have an abnormality of the immune system in the cell growth and cell death     processes that regulate lymphocyte homeostasis.      Patients who have, or are suspected of having, an inherited lymphocyte homeostasis or     programmed cell death susceptibility syndrome may be eligible for this study. Relatives of     patients are also included.      Participants' (patients and relatives) medical records are reviewed and blood samples are     drawn for studies to identify genes involved in immune disorders. Tissues that have been     removed from patients for medical reasons, such as biopsied tissues, may be examined for     tissue and DNA studies. Relatives are studied to determine if some of them may have a very     mild form of lymphocyte homeostasis disorder.      Patients who have an immune problem that the researchers wish to study further will be     invited to donate additional blood samples at irregular intervals (at least once a year) and     to provide an update of their medical records at the same time.   "
184156|NCT00246974|"     The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in     addition to the standard chemotherapy in patients with advanced or metastatic transitional     cell carcinoma of the urothelium by estimating the time to progression.   "
184157|NCT00246987|"     To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses     of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.   "
184158|NCT00247000|"     To demonstrate the safety, feasibility, quality of life, primary caregiver satisfaction, and     cost effectiveness of integrated Home Telehealth care versus standard care in a heart failure     clinic.   "
184148|NCT00246870|"     This study will use brain imaging to map brain cell receptors for a chemical called GABA, a     chemical that inhibits the activities of nerve cells. The study includes patients with     succinic semialdehyde dehydrogenase deficiency, or SSADH (a disorder in which an enzyme     deficiency disrupts GABA metabolism), their parents, and healthy volunteers. SSADH deficiency     causes various neurological and neuromuscular problems, including mild to severe mental     retardation, delays in the acquisition of skills requiring the coordination of mental and     physical activities (psychomotor retardation), delays in language and speech development, and     other symptoms.      Healthy volunteers 18-55 years of age, patients with SSADH between 5 and 24 years of age, and     parents of patients 18-55 years of age may be eligible for this study.      Participants undergo magnetic resonance imaging (MRI) and positron emission tomography (PET)     scanning as follows:      Magnetic resonance imaging      MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For     this procedure, the subject lies on a table that is moved into the scanner (a narrow metal     cylinder surrounded by a magnetic field) wearing earplugs to muffle loud knocking and     thumping sounds that occur during the scanning process. Scanning time varies from 20 minutes     to 3 hours, with most scans lasting between 45 and 90 minutes. Participants may be asked to     lie still for up to 90 minutes at a time. In addition to standard MRI, participants may also     have new types of MRI that may detect brain abnormalities when regular MRI is normal, such as     diffusion tensor MRI and magnetic resonance spectroscopy. There are no noticeable differences     from ordinary MRI scans.      Positron Emission Tomography      A catheter (plastic tube) is placed in a vein in the subject's wrist. The subject lies on a     table with his or her head placed in the scanner. A mask, used to help keep the head still in     the scanner, is placed over the head. The mask is not uncomfortable and has holes for the     subject to see through. A radioactive compound called flumazenil is injected into a vein. The     scan takes about 90 minutes.      Some children need to be sedated for PET or MRI scans. In these cases, chloral hydrate, a     standard drug for pediatric diagnostic procedures, is used.   "
185311|NCT00262392|"     The purpose of this study is to determine whether Bisphosphonates in comparison to radiation     therapy are effective in the prophylaxis and treatment of heterotopic ossification in high     risk patients.   "
184149|NCT00246883|"     This study will evaluate the effects of NHLBI's employee exercise program, Keep the Beat, on     blood vessel function. Damage to blood vessels can cause narrowing of the vessels, resulting     in reduced blood flow to parts of the body such as the heart. Stem cells called endothelial     progenitor cells, or EPCs, may be able to heal blood vessel damage. Exercise, such as walking     on a treadmill, can help move EPCs from the bone marrow where they originate into the blood     stream to help heal the damaged blood vessels. The Keep the Beat program encourages NHLBI     employees to exercise 15 minutes during the workday and provides exercise facilities to     accomplish this.      NHLBI employees who have access to NIH exercise facilities may be eligible for this study.     Candidates must have no history of heart disease, must not currently be exercising more than     1.5 hours per week and must not have participated in the Keep the Beat program for 3 months     prior to entering the study. They are screened with blood tests and blood pressure     measurements.      Participants undergo the following tests and procedures before beginning the study and 3     months after participating in Keep the Beat:        -  Blood tests to identify EPCs and their function, measure the level of nitric oxide (a          gas produced by healthy blood vessels), and measure C-reactive protein (an inflammatory          marker that may be a risk factor for cardiovascular disease).        -  Brachial artery reactivity study to measure how well the arteries widen. An ultrasound          device is placed over the subject's artery just above the elbow. The device measures the          size of the artery and the flow of blood through it before and after a pressure cuff is          inflated around the forearm.        -  Treadmill exercise testing to evaluate physical fitness. Subjects exercise on a          treadmill for as long as they can. An exercise specialist is present throughout the          test. Heart rhythm and oxygen saturation are monitored continuously and blood pressure          is measured every 3 minutes.   "
184150|NCT00246896|"     This is a clinical trial to test the effectiveness of current guideline for the care of older     adults with Alzheimer's disease. The study focuses on the primary care setting using a nurse     care manager to facilitate guideline-level care. We are hypothesizing that patients who     receive guideline-level care will have fewer behavioral problems than those who receive the     usual care provided in primary care settings   "
184151|NCT00246909|"     Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and     esophagus. GERD occurs when the lower esophageal sphincter does not close properly and     stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common     medical disorders, with estimates of up to 50% of adults reporting reflux symptoms daily.     Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD in a large     proportion of patients.      Of particular interest in GERD is the assessment of symptom severity and quality of life, and     the response of these parameters to treatment. Therefore, a questionnaire to assess GERD     symptoms was developed (ReQuest TradeMark). An important point to consider when using such a     questionnaire is to evaluate whether an observed difference in scores after a certain     treatment represents a clinical effect.      The aim of this study is to determine the minimal clinically important difference (MCID) in     patients diagnosed with GERD. During the study, the patients will complete a     patient-orientated, self-assessed reflux questionnaire (ReQuest TradeMark). Endoscopy will be     performed at the start of the study. The study duration consists of a baseline period (1 to 3     weeks) and a treatment period (8 weeks). During the first treatment week, the patients will     receive either pantoprazole (tablet) or placebo once daily in the morning; for the following     7 treatment weeks all patients will receive pantoprazole. The study will provide further data     on safety and tolerability of pantoprazole.   "
184152|NCT00246922|"     The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on     the long-term safety in patients with asthma, who completed the 24-week evaluation of study     APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists     of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05     (registered study). The study will provide further long-term safety and efficacy data of     roflumilast.   "
184153|NCT00246935|"     The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on     the long-term safety in patients with chronic obstructive pulmonary disease (COPD) who     completed the 24-week evaluation of study APTA-2217-06. Roflumilast will be administered     orally once daily. The present study consists of a 28 weeks treatment period, and is an     extension of the 24-week study APTA-2217-06 (registered study). The study will provide     further long-term safety and efficacy data of roflumilast.   "
184154|NCT00246948|"     This Study si designed as a Prospective clinical controlled randomized trial.      Background:      Reviews have demonstrated no or little efficacy for passive conservative treatment modalities     for patients suffering from sciatica. The results of surgery are conflicting. Cohort studies     have shown a high efficacy for active treatment modalities in patients with sciatica. The     current trend in treatment of low back pain without sciatica is focusing on active     conservative treatment like information and advice to stay active and exercises.      Aim: To evaluate the efficacy of two active conservative treatment programs for patients with     severe sciatica.      Methods: In a prospective clinical controlled randomized trial, 181 consecutive patients with     radicular pain below the knee were examined at baseline, 8 weeks later at post treatment     follow-up, and at one year follow-up and MR-scanned at baseline and one year follow-up. The     treatment consisted of four elements: 1-3 were identical in both groups. 1. Thorough     information concerning anatomy, pathogenesis, how discs heal without surgery, and     encouragement to stay as active as possible but to reduce activity if an increase in leg pain     occurs. 2. Tender love and care. 3. Medication; this was optional and only weak analgesic     and NSAIDs were recommended.      Element 4 consisted of two different exercise programs. Symptom guided exercises consisted of     a variety of back related exercises and optional manual treatment. The exercises were given     after an algorithm, where different symptoms or a response to exercises determined the     exercises given. The other group, Sham exercises had voluntary not back related exercises.     The exercises were aimed at increasing the general blood circulation and maintaining strength     in the extremities. Outcome measures were functional status, pain, MRI findings, clinical     findings, and history   "
184155|NCT00246961|"     The purpose of this study is to analyse the effect on quality of life after 3 months of     treatment after changing adjuvant therapy from tamoxifen to Arimidex.   "
184159|NCT00247013|"     The purpose and aim of this study is to test the use of a computer-based, automated     telecommunications system and its effectiveness in increasing the rates of regular screening     mammography among women ages 50-74. The system will not only help in scheduling appointments     but will help women in overcoming any barriers that may deter them from having the procedure     at all. The programs are designed to be user friendly and easy to implement in clinical     practice.   "
184160|NCT00247026|"     To determine the clinical effects of coenzyme Q10 and Curcumin in improving the cytopenias of     patients with myelodysplastic syndromes. we propose to explore the efficacy of the natural     compounds curcumin and CoQ10 in MDS because these two agents possess many of the effects that     are desirable in MDS.   "
184161|NCT00247039|"     To determine the clinical effects of garlic in preventing and treatment of patients with     chemotherapy related febrile neutropenia.These patients have a very high incidence of     infections which are not routinely covered by the standard empiric therapy. Adding a non-     toxic and possibly effective therapy may reduce the risk for infections, synergize the     empiric antibiotic treatment and may lessen the need for broader spectrum and more severe     side effects.   "
194176|NCT00387556|"     Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting     associated with ketamine during procedural sedation in the pediatric emergency department.   "
184163|NCT00247078|"     The purpose of this study is to compare the safety and effectiveness of an investigational     antivenom and the current standard of care (pain management with opioid analgesics) for     treating patients with a widow spider bite. The working hypotheses are as follows:        1. the investigational antivenom is more promptly effective at alleviating the pain          associated with a widow spider bite than routine management with opioid pain medication        2. the investigational antivenom is as safe a treatment as opioid pain medication in          treating patients with a widow spider bite.   "
184164|NCT00247091|"     We conducted a longitudinal study to assess the immunogenicity of standard-titer measles     vaccine in HIV-infected and uninfected Zambian children. The study hypothesis was that     HIV-infected children would have higher rates of primary and secondary measles vaccine     failure compared to uninfected children, contributing to decreased levels of population     immunity to measles and facilitating measles virus transmission in regions of high HIV     prevalence.   "
184165|NCT00247104|"     Cranberries have been proved to reduce the rate of urinary tract infections in a population     of women with recurrent urinary tract infections in previous studies. The purpose of the     study is to examine the efficacy of cranberries in pregnant women with preterm premature     rupture of membranes in a)prolonging the latent period (=the time period between the time the     water broke and delivery of the fetus) and b)reduction of infectious morbidity of both the     mother and infant.   "
184166|NCT00247117|"     The purpose of this study is to examine the effect of metformin on biochemical and     histological findings in NAFLD patients with insulin resistance syndrome.   "
184167|NCT00247130|"     The present study will compare the hemostasis-maintaining effects of intravenous omeprazole     and ranitidine in patients with upper gastrointestinal hemorrhage that have undergone     endoscopic hemostasis, to establish which anti-secretory medication prior to the start of     oral alimentation is effective in preventing re-hemorrhage after hemostasis.   "
184168|NCT00247143|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of higher     doses of lopinavir/ritonavir, in combination with other anti-HIV medications when     administered as either the capsule or liquid formulations, among patients who have not had     full viral suppression despite treatment with 3 classes of HIV medications, and at least 2     prior courses of treatment with HIV protease inhibitors. In addition, pharmacokinetics of the     active agents, lopinavir and ritonavir will be measured following administration of both the     liquid and capsule formulations and compared.   "
184169|NCT00247156|"     1. We hypothesize that children in the experimental group will show a significant improvement     over the control group as all food allergens groups and some other relevant allergenic     substances are desensitized in a systematic way using the NAET® methodology within the     specified period of study.   "
184170|NCT00247169|"     The investigators want to test whether treatment with a natural progesterone intravaginally     increases the cure rate of cervical intraepithelial neoplasia grade I and II.   "
184171|NCT00247182|"     This project provides stepped care to college students mandated for alcohol-related offenses.     Students are first provided with a minimal intervention, a 15-minute discussion of their     alcohol use. Students who continue to drink in a risky manner are provided with a more     intensive, hour-long brief motivational interview. By providing more intensive treatment to     the students who exhibit risky drinking, we hope to maximize the efficiency of campus alcohol     programs.   "
184172|NCT00247195|"     This study will develop and evaluate the effectiveness of a culturally based program that     aims to facilitate entry, retention, and successful treatment in specialized mental health     services for Hispanics with major depressive disorder.   "
184173|NCT00247208|"     The main purpose of this study is to determine whether implantation of a paclitaxel-eluting     stent (Taxus™) in saphenous vein graft lesions will reduce the incidence of in-stent     restenosis after 12 months when compared to a similar bare metal stent.   "
184174|NCT00247221|"     The purpose of this study is to compare the effectiveness of a brief family intervention in     reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17     years old) who are treated in a hospital emergency department for an alcohol-related event.   "
184175|NCT00247234|"     This study intends to compare the effectiveness of schema therapy with standard psychiatric     outpatient care for patients with borderline or avoidant personality disorder.   "
184176|NCT00247247|"     Multi-centre, randomised, parallel-group study, rater-blinded. Total duration of the study     per subject is 12 weeks plus a one- to two-week screening period. There are 6 pre-planned     visits per subject: screening visit followed by 5 visits. Approximately 300 patients     altogether in up to 25 active German study centres and up to 3 active Lithuanian study     centres will be randomised.   "
184202|NCT00253045|"     The purpose of this study is to determine if a group motivational interviewing based     intervention will increase adherence to antiretroviral medications and use of risk reduction     behaviors.   "
184177|NCT00247260|"     Brachytherapy is a recent technique used in the treatment of tumours and involves the use of     radioactive sources brought into close contact with the target tissues. One of the principal     benefits of brachytherapy is that high radiation doses can be localised within the tumour     with the consequence of minimal side effects. 32P is a radionuclide ideal for brachytherapy     as it has high energy beta emitting properties, typically a maximum tissue range of about 8     mm and a half life of 14.3 days. 32P BioSiliconTM is an active implantable medical device     encapsulating 32P within the internal microcrystalline structure of highly pure inert silicon     and acts as a sealed source for the provision of 32 phosphorous.      Tumours targeted with 32P BioSiliconTM are hypothesized to show a reduction in volume with a     low incidence of side effects associated with the treatment. Prolongation of survival and     improved quality of life would be favourable outcomes of the investigational product.   "
184178|NCT00247273|"     The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as     compared to the standard daily dosing regimen of risedronate 5 mg daily.   "
184190|NCT00247429|"     In this study we will assess as a primary objective the effect of venlafaxine retard     treatment on primary care attended elderly patients with depressive syndrome. We will also     study secondarily its effects on anxiety, somatic and painful symptoms of depression.   "
184191|NCT00247442|"     The purpose of the study is to develop and evaluate a decision aid to assist women aged 70     years and over to make an informed choice about whether to continue screening mammography.   "
184179|NCT00247286|"     The purpose of this study is to determine the objective (urodynamic) cure rates and effect on     patient quality of life after six months of treatment for two different nonsurgical     management options for genuine stress urinary incontinence in females: weighted vaginal cones     and formal supervised pelvic floor physiotherapy with biofeedback.      Hypothesis: Assuming a minimum of six months of treatment, weighted vaginal cones are as     effective as a formal supervised program of pelvic floor physiotherapy with biofeedback for     the treatment of uncomplicated genuine stress urinary incontinence in females.   "
184180|NCT00247299|"     The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for     eliminating, among other application, benign vascular lesions and unwanted leg veins. Light     energy heats the deeper structures of the skin. IPL devices provide a broad wavelength     spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by     a reflector and then transmitted through various filters that cut off the lower wavelength     range of the emitted light; therefore, only those wavelengths longer than these of the     filters are transmitted.      objectives:        1. evaluate and optimize the clinical performance of the Luminis ONE platform for each of          the aforementioned clinical applications.        2. Reconfirm the parameter settings for each of the aforementioned clinical applications.        3. Confirm the user friendly design of the device, in aspects of software (user interface)          and various technical operational features.   "
184181|NCT00247312|"     The purpose of this study is to determine the most appropriate radiation implant dose for     palladium-103 monotherapy. Radiation dose is related to potential cure. From previously     published studies, it appears that the prescribed radiation dose can be reduced by 14-20%     without any difference in potential cure (in this study, the dose is being decreased 10%).     Although most patients tolerate brachytherapy well, complications to appear to be related to     radiation exposure to normal structures (i.e. urethra, rectum and proximal penis). By     reducing the prescribed dose, it is conceivable that fewer patients will experience side     effects and complications.   "
184182|NCT00247325|"     In the treatment of coronary heart disease which is the major cause of heart attack, direct     mechanical treatment with catheters such as the coronary angiography,coronary balloon     intervention and stenting intervention are the mainstay of therapy in recent years. In that     procedures, we should use the contrast media, and it may cause kidney toxicity especially in     the patients with underlying kidney disease and decreased kidney function. We intended to     find out which contrast agent has less kidney toxicity in the catheter based treatment of     coronary arterial diseases in patients with underlying decreased kidney function   "
184183|NCT00247338|"     The study is designed to investigate the influence of parenteral nutrition (PN) with low     nitrogen and calorie supply on the clinical outcome of patients after an operation compared     to that of traditional PNs.   "
184184|NCT00247351|"     We performed a prophylactic peroperative linear 1-minute cryolesion connecting the tricuspid     annulus and right atriotomy to prevent IART on 15 consecutive adult patients undergoing     surgery for congenital heart disease. Conduction time between electrodes placed on both sides     of the cryolesion was measured on the second postoperative day. Coronary angiography and     electrophysiology study using an electroanatomic mapping system to assess conduction across     the line were performed three month after the operation on 13 patients.   "
184185|NCT00247364|"     To define the effective dose and tolerability of levetiracetam in individuals with Restless     Legs Syndrome (RLS). It is hypothesized that levetiracetam will be well tolerated, safe and     effective in treating the symptoms of RLS.   "
184186|NCT00247377|"     PURPOSE Obesity is a growing problem in the United States. Severe obesity, known as morbid     obesity, is defined as being 100 pounds in excess of ideal body weight. Nonsurgical     treatments for morbid obesity include exercise, dietary restriction, behavior modification,     and pharmacological intervention. However, it is estimated that most patients undergoing     nonsurgical treatments for weight reduction will regain their weight within 2 to 4 years     after treatment. According to the NIH consensus conference in 1991, surgery remains the only     effective sustained weight loss treatment for morbid obesity. The Roux-en-Y gastric bypass     (GBP) is currently considered the gold standard bariatric surgical operation. Mean weight     loss following GBP is approximately 65% of the excess body weight during the first 12 to 18     months postoperatively. Long-term weight loss is in the range of 55-70% of excess body weight     loss.      Recently, the laparoscopic approach to GBP was reported. Wittgrove and colleagues reported     their results of 75 patients who underwent laparoscopic GBP and demonstrated significant     short-term advantages with comparable weight loss and reversal of comorbidities compared to     the open approach. However, GBP might it be done laparoscopic or open approach can     potentially be associated with significant morbidity and mortality such as anastomotic leak,     pulmonary embolism, bowel obstruction, and postoperative stricture.      The FDA recently approved the laparoscopic adjustable banding system (LAP-BAND) for use in     the United States in June 2001. The LAP-BAND system is a device designed to induce weight     loss in severely obese patients. It is surgically placed around the proximal stomach to     create a small proximal stomach pouch and restricted opening, or stoma, through which passage     of food will be slowed. An inflatable portion along the inner aspect of the band is connected     to an access port, placed intramuscularly. This enabled stoma adjustments to be made without     the need for further surgery. The advantages of the LAP-BAND system included no cutting or     opening of the stomach wall, ability to adjust the stoma and a technically easier operation     to perform than laparoscopic GBP. We wanted to evaluate if the LAP-BAND procedure is as     effective as the laparoscopic GBP procedure for treatment of morbid obesity.   "
184187|NCT00247390|"     The purpose of this study to determine the long-term efficacy and safety of ramelteon, once     daily (QD).   "
184203|NCT00253058|"     To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom     score (TNSS) over the total treatment period from the score of the baseline assessment period   "
190895|NCT00337090|"     The study will examine which dose of YM178 is best in terms of efficacy, safety and     tolerability compared to placebo and compared to tolterodine, a marketed product.   "
184188|NCT00247403|"     Ionizing radiation produces cancer cell death by creating high levels of reactive oxygen     species (ROS), such as superoxide and hydrogen peroxide, in irradiated cells. Cancer cells     are preferentially affected by ROS. The investigators, therefore, propose that interfering     with the detoxification of ROS will make radiation more toxic to cancer cells. Several     cellular mechanisms exist to detoxify ROS, and glucose metabolism plays an important role in     many of these mechanisms. The investigators propose that interfering with glucose metabolism     will sensitize cancer cells to radiation.      The investigators' central hypothesis is that 2DG will sensitize cancer cells to ionizing     radiation by inhibiting the use of glucose to detoxify reactive oxygen species produced by     radiation. As an initial step to evaluate this hypothesis, the investigators have designed     this phase I study.   "
184209|NCT00253136|"     The purpose of the study is to compare the effectiveness and safety of a long-acting     injectable formulation of risperidone (an antipsychotic medication) versus placebo for the     treatment of the symptoms of schizophrenia over a 12-week period.   "
184192|NCT00247455|"     High intake of cereal fibre has been shown to be associated with reduced weight gain and     improved insulin sensitivity. We hypothesize these effects are due to the short chain fatty     acids derived from the bacterial fermentation (breakdown) of fibre in the colon (large     intestine). Insulin resistant subjects will be randomized to receive 2 servings of a     low-fibre cereal (eg. puffed rice) or 2 servings of a high-fibre cereal (wheat bran cereal)     per day for one year. The effects of the diets on body weight, appetite, abdominal fat, blood     short chain fatty acids, glucose, insulin, lipids and hormones will be measured   "
184193|NCT00247468|"     The study objective is to improve morbidity and mortality of high-risk critically ill     children. Our hypothesis is that a strict ICU glucose control protocol will decrease     morbidity and mortality associated with hyperglycemia in a population of high-risk critically     ill pediatric patients.   "
184194|NCT00247481|"     This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of     ZD1839 and placebo in combination with chemotherapy in patients with metastatic breast     cancer.   "
184195|NCT00247494|"     This study is a substudy of the MAN2 -study (Mycophenol mofetil in Antiretroviral Naïve     patients 2, see elsewhere in the ClinicalTrials.gov database). In the MAN2 study, HIV-1     infected patients who are not treated with antiretroviral treatment will be randomized to     treatment with Mycophenol mofetil (MMF)500 mg BID or a control group without treatment (open     label). Both patients randomized to treatment with MMF and patients randomized to the control     group will be asked to participate also in this substudy.      In this substudy we want to show whether monotherapy with Mycophenol mofetil (MMF) in     patients infected with HIV-1 can reduce acceleration of atherogenesis by attenuating various     inflammatory pathways normally involved in progression of atherosclerosis.   "
184196|NCT00247507|"     The aim of this study is to explore and identify the effects of acetylcysteine, a common     mucolytic with anti-oxidant property, on alleviating the damage caused by increased oxidative     stress in hemodialysis patients.   "
184197|NCT00247520|"     The purpose of this study is to see whether rEV131 when given as a nasal spray in a single     dose to each nostril is safe and can reduce the signs and symptoms of allergic rhinitis (hay     fever) caused by an allergen challenge. All patients enrolled will be known to be allergic to     ragweed pollen and will be given ragweed pollen extract in both nostrils 30 minutes after     either rEV131 or innactive vehicle (placebo). The signs and symptoms (sneezing, itching,     stuffiness and runny nose) will each be given a score from 0 to 3 by the patient and these     will be added together and the combined scores from patients treated with rEV131 will be     compared with those who received placebo.   "
184198|NCT00247533|"     There are many reports about the association of coronary artery disease (CAD) and cerebral     artery stenosis (CAS), which had been proved to induce stroke and cognition decline after the     revascularization including coronary bypass surgery (CABG) or percutaneous coronary     intervention. Perfusion defect on nuclear brain scan is also noted to correlate with these     neurological complications. On the other hand, the perioperative arrhythmia and following     cerebral embolism was also attributed to be one factor inducing such neurological hazards.      In the patients with coexistent CAD and CAS (1st group), and also the patients scheduled for     CABG or percutaneous coronary intervention (PCI) (2nd group), we, the researchers at Far     Eastern Memorial Hospital, attempted to integrate all the parameters mention above, including     angiography of coronary and cerebral system, quantitative analysis of nuclear brain scan,     biochemical profile, and signals of a new ambulatory device which could record the     electrocardiograph (ECG) and electroencephalograph (EEG) simultaneously, in order to define     the correlation between them. A chorological relation between EEG signals and ECG signals is     our first target to be worked out. Thereafter, we hope to establish a regression model of all     involved parameters according to the relation. Such a model, we believe, is essential not     only to explain the post-CABG neurological complications, but to prevent them.      Furthermore, for the undetermined ischemic stroke patients who had no obvious culprit artery     or embolism source, the paroxysmal arrhythmia had long been regarded as the cause. Whether a     paroxysmal atrial fibrillation, which had not been disclosed by routine ECG, could induce     most of such a stroke is still not known. With this new ambulatory device which could record     the electrocardiograph (ECG) and electroencephalograph (EEG) simultaneously, we want to     answer the question.   "
184199|NCT00247546|"     The aim of this study is to describe and analyse the effects of multifactorial trial on the     incidence of falls and injurious falls and on different risk factors of falling among the     home-dwelling aged.   "
184200|NCT00247559|"     Despite the wealth of information in the literature regarding the cosmetic applications of     botulinum type A toxin (BoNT-A), and the widespread use of the BoNT-A for cosmetic     applications, the number of randomised, controlled clinical trials is small. Much of the     published information is based on open-label studies or anecdotal data. Of the robust trial     data that is available, the vast majority relates to the treatment of glabellar lines, and     there is little data available regarding the use of BoNT-A in lateral canthal lines. This     study aims to determine the optimum dose for the use of BoNT-A in this area.   "
184201|NCT00253032|"     The study is being performed to determine the efficacy and safety of Fralex Neuromodulation     Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal     pain.   "
184206|NCT00253097|"     Patients with a diagnosis of stroke or TIA, who are already included in the RIALTO-cohort     study are asked to participate in a RCT after discharge from hospital.      Patients in the intervention group will receive four visits by a study nurse with the aim of     controlling the patient's hypertension, reducing risk factors like tobacco smoking and     obesity, and motivating the patient to physical activity and to a healthy diet.Patients in     the control group will receive the usual treatment.      This study is aimed at testing the hypothesis, that      Primary outcome: the blood pressure lowering will be greater in the intervention group     Secondary outcomes: the blood pressure will be lower in the intervention group and the number     of patients who have stopped smoking will be greater in the intervention group The number of     obese patients who have reduced their BMI will be greater in the intervention group The     number of patients with a Rankin Scale<3 who are physically active for four hours a week will     be greater in the intervention group Time to recurrent stroke, MI and death will be longer in     the intervention group      Outcomes are measured by follow up visit one and two years after inclusion in the study      Expected Total Enrollment: 342 in the RCT, 1200 in the cohort      Study Start: 011205 (PREVENT) Study Completion: January 2009(PREVENT), September 2013 (RIALTO     Cohort study)   "
184207|NCT00253110|"     The purpose of the study is to compare the time to relapse in patients with schizophrenia and     schizoaffective disorders receiving risperidone or haloperidol (antipsychotic medications)     for at least 1 year.   "
184208|NCT00253123|"     The purpose of the study is to evaluate the safety and efficacy of risperidone (an     antipsychotic medication) versus placebo in the treatment of behavioral disturbances     associated with dementia.   "
184211|NCT00253162|"     The purpose of the study is to assess the effectiveness and safety of risperidone (an     antipsychotic medication) compared with placebo after 3 weeks of treatment in patients with     bipolar disorder who are experiencing manic episodes. A secondary purpose of the study is to     assess the maintenance of risperidone effectiveness versus haloperidol (an antipsychotic     medication) after 12 weeks of treatment.   "
184212|NCT00253175|"     The primary purpose of this study is to evaluate the effectiveness and safety of topiramate     (an epilepsy medication) compared with placebo in the prevention of migraine.   "
184213|NCT00253188|"     The purpose of this study is to evaluate the safety and effectiveness of two doses of     galantamine (a drug for treating dementia) versus placebo in the treatment of patients with     Alzheimer's disease.   "
184214|NCT00253201|"     The purpose of this study is to evaluate the safety and effectiveness of two doses of     galantamine (a drug for treating dementia) versus placebo in the treatment of patients with     Alzheimer's disease.   "
184215|NCT00253214|"     The purpose of this study is to evaluate the safety and effectiveness of a once daily     controlled-release form of galantamine (a drug for treating dementia) versus placebo in the     treatment of patients with Alzheimer's disease.   "
184216|NCT00253227|"     The purpose of this study is to evaluate the safety and effectiveness of galantamine (a drug     for treating dementia) versus placebo in the treatment of patients with Alzheimer's disease     using a flexible dose design.   "
184217|NCT00253240|"     Family physicians are the primary health care providers for complex patients such as persons     with serious mental illness. The psychiatric needs of these patients could take attention     away from management of health problems and from usual health promotion services. For     example, Schizophrenia is associated with a higher than normal incidence of diabetes, and     first line treatments of Schizophrenia have also been found to increase risk for diabetes. As     such, this high-risk group requires targeted diabetes strategies. In London Ontario, services     are provided to this high risk mental health population primarily by two community agencies:     The Western Ontario Therapeutic Community Hostel (WOTCH) and the Canadian Mental Health     Association (CMHA). Accordingly, the goal of this project is to assess how these patients are     currently being managed by their family physicians and to pilot a community-based,     multidisciplinary diabetes clinic model within this population. If this delivery model proves     feasible and effective, family physicians could be assisted by existing community agencies in     the management of their patients’ diabetes and patients will receive improved access to this     vital multidisciplinary team.   "
184218|NCT00253253|"     The purpose of this study is to determine the long-term outcome in congenital undescended     testis after surgical treatment by orchidopexy and to what extent orchidopexy is the     treatment for congenital undescended testis.   "
184219|NCT00253266|"     This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic     quetiapine in treatment resistant depression.   "
184220|NCT00253279|"     Our specific aim is to gain an understanding of protein synthesis rates in burn patients at     various times during their injury and recovery by using PET scans. This will be compared with     healthy volunteer controls. We hope this will help optimize nutrition and care regimens for     future burn patients.   "
184221|NCT00253292|"     The purpose of this study is to develop a standardized, practical self-administered     questionnaire to monitor young adult burn patients and to evaluate the effectiveness of burn     management treatments with regard to improved function, physical appearance and other     relevant outcomes.   "
184222|NCT00253305|"     The purpose of this study is to compare, in a controlled fashion, the response to two     anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations     in the treatment of subjects with distal subungual tinea unguium of the toenails     (onychomycosis).      The formulation used as the vehicle for the active agents has been shown in earlier studies     to facilitate the penetration of the active agent through fungally-infected nails. This study     will examine dose-response and agent differences in terms of efficacy and safety.      Once the subject has qualified for the study, he/she will be randomly assigned to one of five     study groups, dispensed appropriate study medication and instructed to apply one drop to the     great toe designated for study.   "
184223|NCT00253318|"     Primary:        -  To assess the safety and tolerability and to find the maximum tolerated dose of the          combination administration of RAD001 plus docetaxel when given to patients with          metastatic breast cancer who are being considered for standard docetaxel treatment          (phase I).        -  To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase          I).      Secondary:        -  To determine the phosphorylation status of the components of the mTOR signaling pathway          and the expression of modifiers of apoptosis in the primary breast tumors, in order to          determine whether these markers can be used as predictors of sensitivity to the          combination of RAD001 and docetaxel        -  To determine the effect of the combination of RAD001 and docetaxel on the expression and          phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify          potential pharmacodynamics markers of response to this drug combination   "
184224|NCT00253331|"     The purpose of this study is to determine, in comparison to a placebo control, the response     to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the     determination of finger blood flow and skin temperature in the fingers of patients with     moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.      Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured     using attached thermistor probes. Following baseline measurements, the study gel is applied,     the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored     for the next two hours.      Each patient will receive multiple doses on different days so that each can serve as his/her     own control in interpreting the response.   "
184225|NCT00253344|"     RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the     tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     lenalidomide together with docetaxel may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when     given together with docetaxel in treating patients with advanced solid tumors.   "
194177|NCT00387569|"     A study to assess the safety of an investigational meningitis vaccine in toddlers and their     immune response to it.   "
184226|NCT00253357|"     Heart failure is a progressive disease that decreases the pumping action of the heart. This     may cause a backup of fluid in the heart and may result in heart beat changes. Using a     medical device like a pacemaker or a defibrillator can help the heart to pump in regular     beats. However, not all patients do better with a device. Currently, there is not a way to     identify which patients will benefit from the device. The purpose of this study is to     determine if using medical tests, Echocardiogram, can help in predicting which patients will     improve. The types of patients needed for this study are those who have been diagnosed with     moderate or severe heart failure.   "
184227|NCT00253747|"     The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS     MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e.,     nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence     for smokers with Attention Deficit Hyperactivity Disorder (ADHD).   "
184228|NCT00253760|"     Varied food intake, disease, and genetic differences result in complex diet-health     interactions. In principle, information-rich metabolic analyses combined with bioinformatic     tools provide an approach to explore these interactions. This project is a feasibility study     of the use of high-resolution 1H-nuclear magnetic resonance (NMR) to study metabolic     perturbations induced by a deficiency in sulfur amino acids (SAA). The investigators will 1)     test the hypothesis that deficient dietary intake of SAA in humans results in oxidation of     reduced glutathione (GSH)/oxidized glutathione (GSSG) redox and 2) determine whether 1H-NMR     of blood and urine detects metabolic changes due to SAA deficiency.   "
184229|NCT00253773|"     This pilot study tests the feasibility of using GSH redox state and high resolution proton     NMR spectroscopy (1H-NMR) to detect metabolic changes due to acetominophen and sulfur amino     acid deficiency. Our central hypothesis is that the a 2-day sulfur amino acid deficiency will     alter acetominophen metabolism, acetominophen will affect sulfur amino acid homeostasis, and     the treatments together will alter the global metabolic profile, as measured by 1H-NMR     spectroscopy.   "
184230|NCT00253786|"     Study for the effectiveness of intensive therapy aiming at the remission of diabetic     nephropathy   "
184231|NCT00253799|"     The objective is to assess the safety and efficacy (over the course of 26 weeks) of 2     intra-articular (IA) Hylan GF-20 (Synvisc) injections in addition to customary care in     patients with painful glenohumeral osteoarthritis.   "
184232|NCT00253812|"     The purpose of this study is to establish whether new techniques that may make polyps     (adenomas) stand out better from the background help increase the number of polyps visible at     sigmoidoscopy (telescope test to look inside large bowel) compared to looking with standard     sigmoidoscopy alone.   "
184233|NCT00253825|"     The purpose of the current study is to evaluate relative efficacy of (1)modified     constraint-induced movement therapy (mCIMT) combined with eye patching, (2)mCIMT, and (3)     traditional rehabilitation on motor, attentional, and activities of daily living functions in     stroke patients with unilateral neglect (UN). UN represents a failure to respond or orient to     stimuli presented contralateral to a brain lesion. Constraint-induced movement therapy is     made up of a family of treatment that involve repeatedly practicing use of the affected limb     and constraining use of the unaffected arm in the clinic and at home. mCIMT is an     intervention based on modifications to conventional CIMT by distributing practice sessions to     a longer period of time. mCIMT attempts to supplement the inadequacy of the current     rehabilitation programs and to fit better into rehabilitation schedules. This technique has     been suggested to be especially relevant for treatment of patients with UN.Half-field eye     patching involves occlusion of the hemifield of both eyes (in the case of left UN, the right     hemifields of both eyes). Patching the ipsilateral hemifield is believed to increase     activation of the involved hemisphere, resulting in increased attention to the contralateral     neglected side.      Despite the promising relevance of mCIMT for rehabilitation of patients with hemiplegia, it     remains unclear whether mCIMT is effective for alleviating UN. A further issue that warrants     investigation is the combined effects of mCIMT and eye patching. Both approaches involve the     use of controlled sensory input that may lead to increased activation of the lesioned     hemisphere. Integration of both approaches may be more efficacious than mCIMT without direct     intervention for UN. This project is proposed to study the combined effects of both     approaches. It is hypothesized that combining both approaches will be more effective than     mCIMT, which is hypothesized to be superior to traditional rehabilitation involving the same     amount of therapy time. To test the hypotheses, 60 patients with unilateral stroke and UN     will be recruited and randomly assigned to one of the three treatment groups (i.e., mCIMT and     eye patching, mCIMT, and traditional rehabilitation). Testing for UN will include the use of     the line bisection test, cancellation tasks, and examination for extinction to double     simultaneous stimulations.      The outcome measures will include traditional motor function tests, kinematic analysis, a     circle discrimination test, and daily life functional measures. Each eligible participant     will be tested before and immediately after the assigned intervention and at three months and     six months after the treatment. Each type of treatment will be three-week long. Multivariate     analysis of covariance will be used to analyze the obtained data in order to test for the     relative effects of the three treatments. Each participant will be tested for motivation for     participating in treatment sessions using the Pittsburgh Rehabilitation Participation Scale.     It is hypothesized that patients with higher participation will improve more than those with     lower participation.      The uniqueness of this proposed project pertains to (1)modification of the CIMT protocol in a     more feasible way; (2)concurrent use of mCIMT and eye patching for treating UN post stroke;     and (3)use of kinematic analysis for detecting precise changes in motor behavior post     intervention. Kinematic analysis is relevant for identifying trajectory control deficits that     may accompany clinically “recovered” UN. Findings of this investigation will improve     assessment and treatment for UN that is devastating to functional recovery from stroke.   "
184234|NCT00253838|"     This study compares two different hip stem components. Both hip stems used in this study     allow the femur bone to attach and grow into them for stability. The main difference between     the two stems is that one of the stems, the Solution® Stem, is made from Cobalt Chrome, a     type of metal, and does not have a hydroxylapatite (HA) coating, while the second stem     included in the study, the Restoration hip stem, is made from titanium alloy, a different     type of metal that has a roughened surface and allows for a hydroxylapatite (HA) coating to     be applied to the entire length of the stem. The HA coating is a thin calcium phosphate layer     on the stem to encourage the bone to grow into it. We are trying to see if there is any     difference in the initial bony ingrowth between the two stems and to compare the results in     patients over the first two years after the surgery and then again at the five-year period.   "
184235|NCT00253851|"     The goal of this study is to prevent blood clots from forming during surgery and a few days     after total knee replacement surgery. This study will help us identify whether using a blood     thinner in the operating room will stop blood clots from forming during the operation.   "
184236|NCT00253864|"     The purpose of this prospective database is to investigate the long-term functional status of     patients who have undergone various types of shoulder surgery. Patients are asked to respond     to questionnaires prior to surgery and at various post-operative visits in an attempt to     quantify their functional outcomes. Responses are then linked to other data such as symptoms,     prior treatments, previous surgery, complications, radiographic results, etc. These data may     then be used as a basis for devising guidelines for future patients and surgeons.   "
184238|NCT00253890|"     The purposes of this study are:        1. to evaluate the relationship between subjective complaints of sleep and objective          measures of sleep quality, as measured through polysomnography, and        2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in          methadone maintenance.   "
184239|NCT00253903|"     The purpose of the study is to assess efficacy and safety of eplivanserin in the population     of patients complaining of sleep maintenance insomnia. The patients suffering from that     condition frequently wake up during the night, their sleep is nonrestorative and they suffer     from a significant distress or impairment in their daily activities consecutive to insomnia.   "
184240|NCT00253916|"     Androgen Deprivation Therapy is a commonly used treatment for men with Prostate Cancer.     Unfortunately this can lead to functional decline, fatigue, increased body fatness, loss of     lean body tissue and impaired QOL. Previous research has demonstrated the exercise can may     reduce fatigue and improve QOL in men on ADT. This study will evaluate whether aerobic versus     resistance exercise over a 24 week period of training will reduce morbidity and improve QOL     in men receiving radiation plus or minus ADT with curative intent   "
184241|NCT00253929|"     The endogenous nucleoside adenosine can induce various cardiovascular and neurohumoral     effects by stimulation of specific adenosine receptors. taken together these effects protect     against ischaemia-reperfusion injury of (myocardial)muscles and agsinst the development of     atherosclerosis. Genetic variations in genes encoding for adenosine receptors or for enzymes     involved in the formation or breakdown of adenosine could potentially modulate these effects.     In this study, we aim to determine the functional effects of two frequent genetic     polymorphisms in the adenosine receptor and AMPdeaminase (involved in the formation of     adenosine) on the vascular effects of adenosine.   "
184970|NCT00267254|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      Cholesterol levels will be measured over six weeks in subjects being treated with two     different kinds of cholesterol medications to see how the different treatments compare to one     another.   "
184242|NCT00253942|"     Study wishes to determine if the use of injectable bee venom is a safe and effective     treatment for persons with mild to moderate knee Osteoarthritis and would result in decreased     report of pain and discomfort, increased function during daily activities, decrease use of     analgesic meds, and improvement in walking and climbing steps. We will be using histamine as     a control. 40 subjects will be enrolled in a 3:1 allocation ratio between bee venom and     histamine. Each injection of bee venom dosage will consist of 100 micrograms of dried bee     venom in 0.1 ml. of 0.5% preservative free Xylocaine. The histamine dosage will consist of     .0025 milligrams of histamine in 0.5% preservative free Xylocaine. Subjects will visit the     study center for 14 visits over an 18 week span. The clinical hypothesis is that bee venom is     an effective treatment for Osteoarthritis and will reduce pain and discomfort, increase range     of motion, increase daily function, decrease walking and stair climbing time, and decrease     the need of analgesic medication for a period of time beyond treatment (after the study has     concluded.) The clinical safety hypothesis is that for persons not allergic to bee venom     (patients allergic will not be allowed to enter into the study) the side effects will be     small. The most common side effects for bee venom and histamine will be redness and itchiness     which will be tolerable and safe.   "
184243|NCT00253955|"     Primary Objective:        -  The primary objective of the study is to demonstrate the non-inferiority in clinical          efficacy at the test of cure (TOC) visit planned 5-7 days after treatment completion of          levofloxacin 750 mg once daily (od) in comparison with piperacillin/tazobactam 4 g/500          mg every 8 hours in treating adult patients suffering from mild to moderate          hospital-acquired pneumonia.      Secondary Objectives:      The secondary objectives of the study are:        -  To assess the bacteriological efficacy at the test of cure (TOC) visit        -  To assess the clinical and bacteriological efficacy at the end of study (EOS) visit, 28          to 32 days after treatment ends        -  To assess the tolerability of both drugs   "
184244|NCT00253968|"     The purpose of the study is to assess efficacy and safety of eplivanserin in the population     of patients complaining of sleep maintenance insomnia. The patients suffering from that     condition frequently wake up during the night, their sleep is nonrestorative and they suffer     from a significant distress or impairment in their daily activities consecutive to insomnia.   "
184245|NCT00253981|"     The purpose of this study is to apply Anodyne therapy to active duty soldiers, who have shin     splints, to evaluate healing time and effectiveness.   "
184246|NCT00253994|"     -  Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS)        -  Study Period: August 1, 2003 - December 31, 2004   "
184247|NCT00254007|"     Problem: Depressive symptoms are a common mental health problem following traumatic brain     injury (TBI), occurring in up to 87% of patients. Depression following TBI has important     consequences including poor functioning, lack of ability to return to work and family     activities and prolonged TBI symptoms. The reason depression develops in some patients     following TBI is unknown, making treatment difficult.      One type of brain protein that shows genetic differences between people is called the     serotonin transporter. People can be divided by whether or not they have a short protein (S     allele) or a long protein (L allele) which influences the amount of serotonin transporter.     Serotonin is a key brain chemical in depression in many mental/psychiatric illnesses. We     think that the genetic differences in the serotonin transporter, that may not make a     difference before TBI, may become important after TBI due to the nature of these injuries.      Methods: A consecutive sample of 200 patients attending a TBI clinic who have sustained a     mild-to-moderate TBI (American Congress of Rehabilitation Medicine criteria) within the last     2 months will be assessed for the presence of major depression (standard criteria,     standardized interview). In phase I, blood samples from patients with mild-to-moderate TBI     with depression and without depression will be checked for the presence of the 5-HTTPR     genetic difference. This will allow us to study if the S allele is more likely in TBI     patients with depression. In phase II, the patients with depression will be treated with the     SSRI citalopram for 6 weeks. At 6 weeks, or upon discontinuation of citalopram, depression     will be assessed again. This will allow us to study if depressed patients with the S allele     respond more poorly to treatment. Persons assessing depression after treatment will not know     the genetic makeup of each patient.      Results Expected: If the serotonin transporter genetic difference confers susceptibility to     depression following TBI, this will provide important information on what causes depression     following TBI and document a risk factor for depression previously unstudied in this     population. Also, as SSRI antidepressants are used to treat depression in TBI, this study may     identify a subgroup of TBI patients in whom different medications should be given or     additional medications are required.   "
184284|NCT00254501|"     This study will look at the impact of health insurance benefits on self management of     diabetes for people with this condition. Studies have shown that when people with diabetes     manage their disease better, they stay healthier. Our goal in this study is to help those     with diabetes better manage their disease (self-care). We will compare two types of health     insurance benefits in this study. We want to see if one set of benefits improves self-care     more than the other one.   "
184399|NCT00256061|"     The study hypothesis is that in critically ill patients there is significant differences     between electrolyte levels measured using blood gas analysers and by laboratory techniques,     and between levels measured on arterial and venous blood samples.   "
184248|NCT00254020|"     Depression is a common and often serious problem occurring in stroke patients. Inflammatory     hormones, known as cytokines, are stimulated by an activated immune system and sometimes     become active following a stroke. They may be responsible for altering levels of key     neurotransmitters and their metabolites in the blood and brain of stroke patients. The     investigators' objective is to examine whether increased cytokine activity following a stroke     may be the cause of an increased presence or severity of depression or cognitive impairment     among stroke patients, as a result of tryptophan depletion and/or kynurenine activation. They     are recruiting patients within one month of their strokes and measuring levels of key markers     in their blood. Patients are assessed for the presence of depressive and/or cognitive     symptoms and treated with an antidepressant if needed. The investigators expect to show that     cytokine activation is related to depression and/or cognitive impairment among stroke     patients.   "
184288|NCT00254553|"     Hypogonadal males, particularly those whose condition manifested later in life, may     experience common symptoms associated with their hypogonadism. Questionnaires developed to     assess these symptoms need to be tested. The primary purpose of this study is to test or     validate the Patient-Reported Symptom Measure, Androgen Deficiency Quality of Life     Questionnaire and the Patient Global Impression Scale.   "
184289|NCT00254566|"     This trial is a research drug study to compare the effects of two antibiotics for the     treatment of acute exacerbation of chronic bronchitis   "
184290|NCT00254579|"     CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which     is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate     patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct     effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients     with metastatic melanoma in Phase 1 and Phase 2 clinical studies.   "
184249|NCT00254033|"     Apathy, or lack of motivation, affects up to 80% of Alzheimer's disease (AD) patients. These     amotivational symptoms increase patient reliance on caregivers, increase caregiver burden and     distress, and increase the risk of patient institutionalization. Only 50% of patients with     apathy respond to current treatment with cholinesterase inhibitors. The mechanism of apathy     in AD is unknown hampering rational treatment. Our proposed pilot study will provide initial     data required to develop an amphetamine challenge paradigm to probe the brain reward system.     These results will be used to develop a larger study evaluating the role of the brain reward     system in apathy in AD and link this information with pharmacologic treatment. AD is a     complex neurobiological illness that needs to be understood at several levels to optimize     treatment. At a neurochemical level, one has to identify the neurotransmitter abnormalities     that accompany the clinical symptoms. The neurochemical level of analysis provides the link     between pathology and symptoms and, for now, is the only avenue for biological therapies.     Next, one has to translate knowledge of neurochemical abnormalities to practical treatments     for the symptoms of AD. This pilot will allow us to develop a study that can address both of     these goals. Furthermore, the larger study will further define the emerging concept of apathy     as a syndrome and has broader implications for apathy in many other neuropsychiatric     diseases.   "
184250|NCT00254046|"     The purpose of this study is research with the goal of evaluating the effect of TMC125 (a     non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus.     The study will also investigate whether this new medication is well tolerated, and to further     confirm that the medication is safe to be used.   "
184251|NCT00254059|"     This study will look at an alternative new pathway for diagnosis and treatment based on     simple procedures in the patient’s own home compared with the current conventional laboratory     based pathway. The purpose is to determine whether all patients with OSA require the more     elaborate laboratory procedures, or whether a subgroup can be managed more simply.   "
184252|NCT00254072|"     Laparoscopic gastric bypass surgery is a common procedure being performed for the treatment     of morbid obesity. The procedure consists of a creation of a small gastric pouch and     rerouting the small bowel to bypass the stomach and duodenum. There are two anastomoses in     this procedure: the gastrojejunostomy and the jejunojejunostomy. Potential complications     after gastric bypass include gastrointestinal bleeding and leaks. Gastrointestinal bleeding     can occur at any staple line including the gastrojejunostomy. Potential methods for     prevention of postoperative gastrointestinal bleeding include oversewing of the anastomosis     or the use of a smaller stapler height. We hypothesize that the use of staplers with smaller     staple height will significantly result in a lower rate of staple line bleeding and possible     leaks.   "
184253|NCT00254085|"     The purpose of the project is to shown whether a little dose of a short acting insulin     analogue given 3 time daily before the meals compared with placebo could normalise the     increase in blood glucose after teh meals in diet treated Type 2 diabetic patients.   "
184254|NCT00254111|"     The purpose of this study is to determine whether low level light therapy is effective in the     treatment of osteoarthritis of the hand, when the treatment is applied to the hand by an     individual in his or her own home.   "
184255|NCT00254124|"     The purpose of this study was to determine whether a food portion control tool would be     effective to result in weight loss in a group of overweight type 2 diabetics. We hypothesized     that this tool would be effective to induce weight loss in these patients. We also     hypothesized that diabetic control would be improved in patients using these plates.   "
184256|NCT00254137|"     A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus     irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in     first-line treatment of patients with metastatic colorectal cancer.   "
184257|NCT00254150|"     Postoperative organ failures commonly occur after major abdominal surgery and substantially     increase the utilization of resources and the costs of care, and are favored by tissue     hypoxia. A therapeutic strategy designed to detect and reverse tissue hypoxia, as diagnosed     by an increase of oxygen extraction over a pre-defined threshold could decrease the incidence     of organ failures.   "
184258|NCT00254163|"     The purpose of this research study is to find out what effects (good and bad) the combination     of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of     these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other     cancers, these combinations are experimental for the treatment of CLL.   "
184285|NCT00254514|"     This trial is conducted in Africa, Europe and Middle East. This trial investigates the     efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to     placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the     first part, the patients will be evaluated with regard to efficacy (fracture healing) and     safety at short time intervals until week 24 post-surgery. In the second part, long-term     safety and fracture healing up to 12 months post-surgery will be evaluated.   "
184286|NCT00254527|"     The intent of this study is to:        1. Define the prevalence of MRSA carriage in the pediatric population in Kansas City.        2. Systematically define patient risk factors for MRSA carriage and infection.        3. Characterize the unique genetic characteristics of MRSA strains, both community acquired          (CA) and healthcare associated (HCA) that are present in the different pediatric          populations.   "
184311|NCT00254852|"     The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to     autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one     level is defined as two adjacent vertebrae), L2 and below.      The primary endpoint will be the assessment of fusion by evaluation of x-rays taken following     surgery at each visit. The x-ray evaluation will be conducted by a radiologist who is blinded     to the type of treatment each patient has received.      Subjects will be seen at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative     (post-op). Questionnaires and x-rays will be completed at each visit and a computed     tomography (CT) scan will be taken at the 12 month visit(and used to aid in assessment of     bridging bone, where appropriate).   "
184971|NCT00267267|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      Cholesterol levels will be measured over six weeks in subjects being treated with two     different kinds of combination cholesterol medications to see how the different treatments     compare to one another.   "
184259|NCT00254176|"     Critically ill babies less than 1 month of age have deficient amounts of the antioxidant     glutathione and a high incidence of disease associated with oxidative injury compared to     healthy babies. These diseases include but are not limited to damage to the eyes, lungs, and     intestines. Frequently becoming chronic and potentially life threatening, these diseases     result in a significantly decreased quality of life to the infant along with increased costs     to the infant's family and society.      The amino acid cysteine comprises a third of the tripeptide glutathione and directly     influences glutathione production. Older children ill with infection and stable, premature     neonates administered cysteine supplementation to their diet have been previously shown to     increase their glutathione production and concentrations. Furthermore, cysteine     supplementation in the ill children resulted in a quicker resolution of their illness.      Although most critically ill babies require IV nutrition (i.e., TPN) before and during their     illness, commercially available TPN does not include cysteine as a significant nutrient.     Cysteine has effectively become a safe and standard supplement to routine TPN in a few major     hospitals in the U.S.      The purpose of this study is to evaluate the ability of cysteine supplementation to increase     glutathione production and concentrations in critically ill babies. Furthermore, the     investigators want to evaluate whether cysteine supplementation results in less oxidative     tissue injury and ultimately less severe illnesses. The study will enroll babies admitted to     the UCLA Medical Center Neonatal Intensive Care Unit (NICU) and they will be chosen at random     and in a blinded fashion to receive either cysteine or non-cysteine supplementation to their     routine TPN. Small blood samples along with a single 6 hour infusion of a non-radioactive,     stable isotope labeled amino acid will be used to measure the production of glutathione as     well as other compounds in the blood to give a quantitative assessment to the severity of     illness. Clinical information relevant to the babies' illness and subsequent recovery will be     recorded.      The results will be compared between cysteine vs. non-cysteine groups and before vs. after     individual supplementation. By demonstrating the effect of cysteine supplementation on     glutathione production, the incidence and/or severity of disease from oxidative injury in     critically ill babies may be decreased if glutathione production is improved.   "
184260|NCT00254189|"     To determine the ability of a monophasic oral contraceptives (OC) regimen of Levonorgestrel     (LNG) 90 mg and Ethinyl Estradiol (EE) 20 mg to inhibit ovulation during 84 days of     continuous therapy.   "
184261|NCT00254202|"     The purpose of this study is to determine the safety and efficacy of iloperidone compared to     placebo and an active comparator in the treatment of patients with schizophrenia in acute     exacerbation.   "
184262|NCT00254215|"     To investigate the hypothesis that reducing the glycemic load of the diet will improve     changes in body composition and cardio-vascular risk factors. The study compares a     conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load:     changing the carbohydrates to low-GI choices, replacing some of the carbohydrate with     protein, or combining both effects to produce the lowest glycemic load.   "
184263|NCT00254228|"     The purpose of this study is to determine whether the BrainPort™ balance device is safe and     effective in the treatment of balance disorders in patients with Bilateral Vestibular     Dysfunction.   "
184264|NCT00254241|"     To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode     schizophrenia   "
184265|NCT00254254|"     This study will be the first evaluation of exenatide in adolescent subjects with type 2     diabetes mellitus and is designed to evaluate the blood levels of the drug     (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and     tolerability of exenatide in these subjects.   "
184266|NCT00254267|"     The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with     gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.   "
184267|NCT00254280|"     The purpose of the study is for recalcitrant hand and foot warts to compare the efficacy of     treatment with Intense Pulsed Light and paring versus paring alone.   "
184268|NCT00254293|"     The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in     subjects with RA.   "
184269|NCT00254306|"     Recreational use of ecstasy (MDMA; 3,4-methylenedioxymethamphetamine) is associated with     long-lasting effects on metabolism in the human brain. The investigators propose to     investigate whether chronic use of ecstasy is associated with impairment in motor skills     and function of the dopaminergic system in recreational users of ecstasy compared with     healthy volunteers. This will be done by scanning control subjects and ecstasy users at     baseline and after performing on a motorbike riding computer game, while imaging dopamine in     vivo with I123-IBZM (a D2 receptor radiotracer), using single photon emission computed     tomography (SPECT).   "
184270|NCT00254319|"     Avastin is a novel antiangiogenic agent that has recently been shown to improve response     rates and survival of patients with advanced nonsquamous non-small cell lung cancer when     added to front-line carboplatin/paclitaxel chemotherapy, and is now being routinely     incorporated into the treatment of these patients. Alimta is a recently approved     chemotherapeutic that has shown activity against non-small cell lung cancer when given alone     and in combination with carboplatin, has a favorable toxicity profile andrequires only a     brief (10 minute) infusion time. Therefore we propose to study the combination of Avasin,     Alimta, and Carboplatin administered as front-line therapy to patients with advanced     nonsquamous non-small cell lung cancer.   "
184271|NCT00254332|"     This is a blood and tissue study to determine the effect of the drug called denileukin     diftitox on the immune system cells that may be involved in patient response to their     cutaneous t-cell lymphoma.      Patients who are undergoing standard of care therapy with denileukin diftitox will be invited     to participate. Blood and tissue samples will be obtained at baseline, day 5 and day 19 in up     to the first 4 cycles of denileukin diftitox.   "
184272|NCT00254345|"     Auto polymerizing poly methyl methacrylate (PMMA), and light initiated resin modified PMMAs,     are commonly used for fabricating provisional restorations (PRs) during prosthetic treatment     1. Biofilm accumulated on these PRs may cause caries and inflammation of the surrounding     tissue, tempering the outcome of the final restoration 2. Plaque adherence to temporary     restorations was significantly increased compared with the untreated reference teeth 3.     Biologic and physical properties of the various materials used as PRs were studied     extensively 4-8 whereas their interaction with bacterial biofilm in vivo and ex vivo is less     characterized.      One improvement in provisional restorative materials is the use of liquid polish. It is     claimed that these materials gives a high luster finish to provisional bis-acryl restorations     and processed acrylic appliances, reduces or eliminates costly and time consuming polishing     steps and can be used on all types of direct and indirect restorations and appliances.The     effect of liquid polish coating or resin bonding coating on biofilm formation on PRs was not     reported.   "
184287|NCT00254540|"     To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally     once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with     metastatic Renal Cell Cancer (RCC).   "
185114|NCT00269217|"     This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed     hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6     scheduled clinic visits, and 7 treatment arms.   "
184273|NCT00254358|"     Tobacco Smoking is the most prevalent addiction in society today causing directly major     health hazards and sharing morbidity with other psychiatric disorders. Nicotine binds to     acetylcholine receptors and thus elevates DA release and inhibits DA transport. There are few     studies using advanced brain imaging techniques to investigate how nicotine releases dopamine     in humans. These studies utilized dopamine displacement paradigms with [11C] Raclopride     binding to D2 receptor in Positron Emission Tomography (PET). There is evidence that smokers     (particularly those who enjoyed smoking) showed decreased [11C] Raclopride binding in the     caudate/nucleus accumbens and putamen after smoking cigarettes. These results also indicated     that the effects of nicotine on dopaminergic neurotransmission are mediated by pleasure and     craving. We propose to investigate the effects of smoking a cigarette ad lib on dopamine     release by using dopamine competition paradigm with [I123] IBZM in SPECT. Secondly, we will     test the hypothesis that dopamine deficiency is a major vulnerability factor for smoking.     This may provide further evidence that dopamine deficiency in some smokers pre-disposes them     to enjoy and desire smoking cigarettes more than others.   "
184274|NCT00254371|"     Sarcopenia is a major health problem among the rapidly expanding elderly population in our     society. Disabilities directly related to muscle weakness, and indirectly related to changes     in body composition and metabolic dysfunctions, are causing a staggering toll in disability     and health care costs.      Osteopenia occurs almost simultaneously with sarcopenia in the elderly population and muscle     weakness increases the risk for falls and therefore, fractures. Although these issues have     been separate addressed in several studies, an integrated investigational approach to better     understand the pathogenesis of sarcopenia and other age-related metabolic abnormalities and     to investigate the potential role of androgens have not been undertaken in a comprehensive     manner.      The program contains four independent research programs, each representing different research     disciplines, and four separate cores supporting the four projects.      The main focus of the project is to determine the effect of the replacement of testosterone     in elderly men and DHEA in elderly men and women and to compare these effects with placebo     treatment over a two-year period.      Project 1, Effect of Androgen Replacement on Muscle Metabolism will specifically determine     whether these interventions have a differential effect on size and quality of muscle in terms     of strength and metabolic functions. Project 2, Effect of Androgen Replacement on Bone     Metabolism, will determine the effects of this intervention on bone mineral density and     markers of bone turnover.      Project 3, The Effect of Androgen Replacement on Carbohydrate Metabolism, will determine     whether the age-associated decrease in circulating androgens contributes to the alterations     in carbohydrate metabolism that are commonly observed in the elderly and on insulin action,     insulin secretion, and glucose effectiveness.      Project 4, Effect of Androgen Replacement on Fat Metabolism will determine whether changes     in fat distribution that occur with aging could result from differences in regional fatty     acid uptake and systemic fatty acid kinetics, and whether these determinants of fat     distribution are altered by the interventions.      The data emerging from these studies will be integrated to determine the intervention of     sarcopenia with other metabolic changes and hopefully will contribute to a better     understanding of muscle, bone, carbohydrate and fat metabolism.      This study will hopefully form the scientific basis for future trials of androgen replacement     in the elderly.   "
184275|NCT00254384|"     The goal of this clinical research study is to learn if chemotherapy (cisplatin, docetaxel)     is safe to give to patients whose lung cancer will be surgically removed, and to learn if     maintenance therapy with the biologic agent erlotinib, given after surgery, is safe. Another     goal of this study is to look at changes that occur in epidermal growth factor receptor     (EGFR) and how these changes are reflected in different cells in the body. The effect of this     treatment on the participant's quality of life and survival, as well as its effect on     different cells in the body, will also be studied.   "
184276|NCT00254397|"     The goal of this clinical research study is to learn if the drug leuprolide will increase the     level of immune cells in your body. Researchers will also want to know if this drug given     together with melanoma vaccines (gp100 and MAGE-3) can improve the ability of tumor fighting     immune cells (T cells) to fight melanoma cells.      Primary Objective:      1. To compare the tumor-specific immune responses to melanoma-specific peptide vaccines,     gp100 and MAGE-3 in the presence or absence of a luteinizing hormone-releasing hormone (LHRH)     agonist-Leuprolide, in patients with stage IIb and III melanoma, uveal melanoma or stage IV     melanoma that the metastatic lesion(s) has been surgically removed.      Secondary Objectives:        1. To evaluate the kinetics of enhanced thymic activity measured by TREC analysis and flow          cytometric analysis following sex hormone ablation by Leuprolide in melanoma patients.        2. To assess whether there are significant differences in overall quality of life (QOL)          between patients receiving Leuprolide to those not receiving leuprolide.   "
184277|NCT00254410|"     The goal of this clinical research study is to learn if using a combination of fludarabine,     cyclophosphamide, and mitoxantrone plus rituximab, with the growth factor pegylated     filgrastim, will improve the response to treatment, and increase the time this response     lasts, for patients with previously untreated CLL. The safety of this combination will also     be studied.   "
184278|NCT00254423|"     The goal of this clinical research study is to learn if BMS-354825 (dasatinib) can help to     control CML in chronic phase. The safety of this drug will also be studied.   "
184279|NCT00254436|"     To demonstrate the effectiveness of epoetin alfa on reduction in red blood cell transfusions     in gastric and rectal cancer patients undergoing preoperative chemoradiation therapy followed     by surgery.   "
184280|NCT00254449|"     The purpose of this study is to evaluate epidermal nerve fiber (ENF) regeneration and     normalization of peripheral sensory nerve function over time in normal healthy volunteers     following a 60 minute application of Capsaicin Dermal Patch (NGX 4010; capsaicin 640 mcg/cm2)     as compared to comparable untreated skin areas (control).The objectives of this study are: 1)     To assess the difference between patch-treated and comparable untreated skin areas (control)     in ENFD as quantified by PGP 9.5 immunohistochemical staining of skin biopsy samples obtained     at 1, 12 and 24 weeks following a 60 minute application; 2) To assess the difference between     patch-treated and comparable untreated skin areas (control) for thermal detection thresholds     as assessed by QST at 1, 12 and 24 weeks following a 60 minute application; and, 3) To assess     the difference between patch-treated and comparable untreated skin areas (control) in     mechanical (sharp pain) sensation and tactile threshold at 1, 12 and 24 weeks following a 60     minute application.   "
184281|NCT00254462|"     This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of     attention deficit hyperactivity disorder (ADHD) in young children.   "
184282|NCT00254475|"     The purpose of this study is to provide data on the dose response of simvastatin in lowering     LDL-C when it is co-administered with valsartan in patients with both essential hypertension     and hypercholesterolemia. The primary objective of the study will be to show that the     combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the     combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.   "
184283|NCT00254488|"     This study will compare the benefits and side effects of lithium and divalproex in the     treatment of older adults with bipolar mania.   "
184291|NCT00254592|"     Study Aims        1. To measure the clinic response rates in patients with breast cancer more than 2 cm          and/or lymph node positive breast cancer treated with 2-4 cycles of biweekly          doxorubicin, cyclophosphamide with Granulocyte-macrophage colony-stimulating factor          (GM-CSF) (days 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks,          followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in          addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will          receive Bevacizumab (6-8 doses) q 2 weeks).        2. To measure the microscopic pathological response rate of this regimen.        3. To measure toxicity and the delivered dose intensity of this regimen.        4. To assess the association between microscopic pathologic complete response and clinical          complete response at the primary tumor site in these patients.        5. To determine whether the GM-CSF increases the post treatment dendritic cells (S100+)          percentage in the tumor draining lymph node as compared to pretreatment S100+ cells.        6. To determine whether the patients with a higher percent S100+ have a better clinical,          pathological response, Disease Free Survival (DFS), and overall Survival (OS).        7. To determine whether flow cytometry of dendritic cells performed post-treatment in blood          sample shows an increase in dendritic cell population compared to pretreatment levels.   "
184292|NCT00254605|"     The purpose of this study is to determine whether the structure and function of the human     retina can be studied with high resolution in patients with inherited retinal degenerations     using the Adaptive Optics Scanning Laser Ophthalmoscope (AOSLO).   "
184293|NCT00254618|"     The purpose of this randomized, open-label, parallel-group study is to determine how the body     absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60     mg/kg/day or 90 mg/kg/day as 400 mg delayed-release tablets given every 12 hours of 28 days     to children and adolescents with active ulcerative colitis.   "
184294|NCT00254631|"     We would like to check whether pre-operative administration of an oral controlled-release     opioid formulation (Oxycodone hydrochloride (OxyContin)) could result in a clear effect of     preemptive analgesia.   "
184295|NCT00254644|"     Developmental dyslexia is a frequent learning disability. The aim of this study is to analyze     cortical thickness and phonological treatment in right handed adults with developmental     dyslexia. They are compared to control adults paired with age and laterality. To study     phonological treatment, the researchers used functional magnetic resonance imaging (fMRI)     with a rime judgement task and silent word generation.   "
184296|NCT00254657|"     The purpose of this study is to assess the safety and effectiveness of levetiracetam in     reducing the pain of fibromyalgia when compared to placebo. Levetiracetam, an anti-seizure     drug, is currently FDA-approved and marketed for use in patients with seizures. Levetiracetam     may relieve pain by reducing abnormal activity in the nervous system. A placebo is an     inactive substance.   "
184297|NCT00254670|"     The purpose of this study is to examine drinking behavior and decision-making while taking     Naltrexone and placebo. This is a double-blind, randomized, placebo-controlled crossover     study. There are two cycles: one cycle on Naltrexone and one cycle on placebo.   "
184298|NCT00254683|"     Preoperative chemoradiation therapy is the preferred initial treatment option for distal     rectal cancers. However, assessing tumor response to preoperative chemoradiation therapy     remains a challenge to the colorectal surgeon, especially when determining if there is a     complete response, observed in more than 10% of cases. The purpose of this study is to     evaluate the use of the PET/CT in assessing distal rectal tumor response to preoperative     chemoradiation therapy.   "
184299|NCT00254696|"     -  To determine the value of using piperacillin/tazobactam in reducing the cases of ESBL          producing E. coli or K. pneumoniae colonization and infection.        -  To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre          and post intervention in the selected medical centers.   "
184300|NCT00254709|"     The purpose of this study is to test two different sirolimus-based immunosuppressive regimens     for elderly kidney transplant recipients.   "
184301|NCT00254722|"     The purpose of this study is to determine if bone marrow progenitor cell (BMPC) autologous     transplantation in children after isolated traumatic brain injury is safe and will improve     functional outcome.   "
184302|NCT00254735|"     The purpose of the study is to evaluate the efficacy of quetiapine or placebo added to     baseline treatment of SSRI/clomipramine for the treatment of OCD in adult subjects.   "
184303|NCT00254748|"     In patients with schizophrenia, 'atypical' antipsychotics such as clozapine may be effective     in the treatment of psychosis. In patients with borderline personality disorder (BPD), as far     as the investigators know, no well designed controlled studies have been performed on the     effect of one of the newer atypical antipsychotics on psychotic symptoms.      It is of interest to investigate the benefit of quetiapine treatment in these types of     patients. Quetiapine possibly gives less side-effects because of the expected lack of     elevated prolactin levels, which is of importance in this patient group, overrepresented by     young females. In this double blind, randomized, placebo controlled, 8 week, parallel group,     multi-center study, quetiapine (in flexible doses between 200 mg/day and 600 mg/day) will be     compared with the placebo.   "
184304|NCT00254761|"     To determine if smoking marijuana will reduce neuropathic pain without causing too much     drowsiness or feeling too dopey.   "
184309|NCT00254826|"     The purpose of this study is to determine whether immune globulin can limit the amount of     yellow fever vaccine virus present in the blood after vaccination without compromising the     immunity associated with the yellow fever vaccine. The study will enroll 80 participants in     two groups of 40 each. The first group will receive the yellow fever vaccine with salt-water     placebo. The second group will receive yellow fever vaccine with immune globulin. The amount     of vaccine virus and immune response in both groups will be compared. Yellow fever vaccine     has been used to protect humans against Yellow Fever Vaccine disease since the 1930s.   "
184310|NCT00254839|"     Malodor production is bacterial in origin. The bacterial activity of anaerobic bacteria     results in the breakdown of proteins and the production of foul smelling compounds. The aim     of the study is to test the hypothesis that bacterial growth on dental implants contributes     to malodor production and to see whether this contribution is associated with various     properties of the dental implant such as: maker, type, depth ext.   "
184312|NCT00254865|"     The objective of this study is to compare the levels of the hormones norelgestromin,     norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers     administered ORTHO EVRAÂ® (a transdermal contraceptive patch) and CILESTÂ® (an oral     contraceptive). The open-label treatment phase of the study consists of two 28-day cycles of     one treatment, a washout period of 28 days, and crossover to two 28-day cycles of the other     treatment.   "
184313|NCT00254878|"     Currently two different brands of modified-release formulations are providing 50% immediate     release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and     dual peak concentrations of plasma methylphenidate. One is manufactured by Novartis, the     other one by Medice (Germany).      The objective of the study is to test the hypothesis that the Novartis product is superior to     placebo and is clinically not inferior to the formulation manufactured by Medice.   "
184314|NCT00254891|"     To assess the efficacy and safety of PF-3512676 administered in combination with     paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced     or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety     of paclitaxel   "
184315|NCT00254904|"     To assess the efficacy and safety of PF-3512676 administered in combination with     gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced     or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety     of gemcitabine/cisplatin alone.   "
184316|NCT00254917|"     The present clinical study will assess the immunogenicity and reactogenicity of the     subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine     (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age     schedule followed by a booster vaccination during the second year of life with the aim to     cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus,     pertussis, poliomyelitis and Hib vaccines.      WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14 weeks     of age) will be also assessed in infants born to HBsAg seronegative mothers.      To assess the safety of Pentaxim.   "
184317|NCT00254930|"     The purpose of this study is to assess whether risperidone (an antipsychotic medication) is     safe and effective in treating behaviour disorder in learning disabled children, which does     not improve with psychological therapy.   "
184318|NCT00254956|"     The primary objective is to demonstrate the non-inferiority of ciclesonide compared to     beclomethasone-HFA in the occurrence of Class 1 lens event for nuclear (NO), cortical (C), or     posterior subcapsular (P) lens opacification within 12 months. Secondary objectives are to     compare ciclesonide and beclomethasone with respect to class II and class III best corrected     visual acuity and intraocular pressure from baseline to 12 months.   "
184319|NCT00254969|"     The present clinical study will assess the immunogenicity and reactogenicity of Aventis     Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary     vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of     life in order to meet the requirements for application for the use of the product in the     Expanded Program on Immunization (EPI) in South Africa.   "
184320|NCT00254982|"     This is an open-label, multicenter, parallel-group comparison study of the efficacy, safety,     and tolerability of infliximab therapy in adult patients suffering from chronic plaque     psoriasis (psoriasis vulgaris). Patients will be assigned to GROUP I (high need) or GROUP     II (low-need) by the investigator according to their previous psoriasis treatment.   "
184321|NCT00254995|"     To further characterize the safety profile of Menactra vaccine and to identify any signals of     potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.   "
184322|NCT00255008|"     This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy     with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1     chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian     patients with genotype 1 chronic hepatitis C. This study is also designed to provide a     randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in     Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic     response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at     24 weeks after therapy completion.   "
184323|NCT00255021|"     The present clinical study will assess the immunogenicity and reactogenicity of Sanofi     Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary     vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of     life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.   "
184324|NCT00255034|"     This is an Australian, open-label, multicenter, randomized, double-blind clinical trial     designed to assess the efficacy of combination therapy with pegylated interferon alfa-2b and     ribavirin for 48 weeks versus 24 weeks in the treatment of chronic hepatitis C     (treatment-naïve genotype 3 subjects with high viral loads who have a METAVIR score of at     least F1A2). The primary endpoint will be a sustained virological response defined by     undetectable HCV RNA in serum at 24 weeks after completion of therapy.   "
184325|NCT00255047|"     The overall aim of the study is to corroborate that a schedule consisting of 3 doses of     Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of     Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3     doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus     vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.   "
184326|NCT00255060|"     To screen women who are high risk for breast cancer with breast MRI, mammogram and random     periareolar fine needle aspiration.   "
184360|NCT00255515|"     The purpose of this study is to compare efficacy of quetiapine fumarate combined with     Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social     outcome in patients with schizophrenia.   "
184403|NCT00256113|"     The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)     in patients with depression.      The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to     placebo in patients with depression.      The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy     of saredutant on disability and quality of life in patients with depression, and to evaluate     blood levels of saredutant.   "
184327|NCT00255073|"     Reduction of spasticity has been a major focus of the treatment of childhood cerebral palsy,     resulting in numerous treatment strategies that target various parts of the motor system.     However, in many children weakness may be a greater contributor to disability than     spasticity. Recent results suggest a correlation between spasticity and weakness, but it is     not known if reduction of spasticity can improve strength.      We suggest a simplified model in which spinal mechanisms (including reflex contributions to     spasticity) and supraspinal mechanisms (including voluntary contributions to strength)     combine to activate muscle. The model implies that the supraspinal contribution cannot     increase unless the spinal contribution decreases. We therefore hypothesize that reduction of     spasticity improves the ability to increase voluntary strength.      We propose a double-masked placebo-controlled clinical trial combining treatment using the     oral anti-spasticity medication baclofen with a 6-week program of strength training. We will     enroll 20 ambulatory children with spastic diplegic cerebral palsy. Prior to and following     the intervention, we will obtain quantitative measures of spasticity, strength, and gait. We     predict that the children taking baclofen will have a greater increase in strength than the     children taking placebo. We predict that the increase in strength will be reflected in     improved performance on gait analysis, and it will correlate with a reduction in quantitative     measures of spasticity and spinal reflex excitability.      If the hypothesis is correct, it will provide important new information on the relationship     between spasticity and strength in children with cerebral palsy. It will provide the first     measurements of the effect of baclofen on voluntary muscle activation in children. It will     support the short-term use of combined anti-spasticity medication and strengthening as a new     clinical treatment for ankle weakness in children with spastic diplegia. A successful result     will have immediate and significant implications for treatment of children with cerebral     palsy.   "
184328|NCT00255086|"     The aim of the proposed study is to determine if the NMDA receptor antagonist memantine has a     neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of brain     NAA and magnetic resonance imaging (MRI) volumetric measures of hippocampal volume. In     secondary analyses, we will determine if measures of clinical stabilization produced by     memantine in the treatment of Alzheimer's disease (AD) parallels stabilization of MRS     measures of brain NAA and MRI volumetric measures of hippocampal volume.   "
184329|NCT00255099|"     The purpose of this study is research with the goal of evaluating the effect of TMC125 (a     non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus.     The study will also investigate whether this new medication is well tolerated, and to further     confirm that the medication is safe to be used   "
184330|NCT00255112|"     The purpose of this study is to determine whether a specific family based cognitive     behavioral treatment program is effective in the treatment of children with separation     anxiety disorder.   "
184331|NCT00255125|"     This is a randomized study evaluating the effectiveness and direct effect a commercial soy     supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it     either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned     surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be     evaluated to determine the effects of the soy supplement on the prostate tissue.   "
184332|NCT00255138|"     The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in     enhancing attention and concentration among childhood survivors of cancer.   "
184333|NCT00255151|"     The purpose of this study is to assess the ability of once-daily (QD) treatment with     Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of     erosive esophagitis (EE).   "
184334|NCT00255164|"     The purpose of this study is to assess the ability of once-daily (QD) treatment with     Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of     erosive esophagitis (EE).   "
184335|NCT00255177|"     Hepatitis C virus (HCV) infects approximately 170 million people worldwide. The current     standard- of- care therapy of chronic HCV infection is a regimen of subcutaneously     administered (pegylated)-interferon-α and ribavirin for 24 weeks (for genotypes 2 and 3) to     48 weeks (for genotype 1). The sustained viral response rates (SVR) in patients infected with     genotypes 2 and 3 are ~80% but remain <50% in patients infected with genotype 1. The     treatment is quite toxic with approximately 30% of patients experiencing adverse events (i.e.     depression, fever, anemia, fatigue) requiring dose reduction or discontinuation of therapy.     This regimen is contraindicated in women who are pregnant and in patients with decompensated     liver disease. The absence of acceptable therapies for many patients with HCV infections     makes new therapies desirable for this disease.   "
184336|NCT00255190|"     The purpose of this study is to determine the long-term safety profile of daily treatment     with dexlansoprazole MR in subjects with gastroesophageal reflux disease.   "
184337|NCT00255216|"     Policosanol, a compound derived from sugar cane wax and available in health food stores     across the United States, is a popular non-prescription product for treating     hypercholesterolemia. Virtually all of the published medical literature on policosanol has     been authored by research groups in Cuba.      This study will assess the short-term safety and efficacy of policosanol in healthy adults     who have a baseline LDL-C of 130-200. The recruitment population will be derived from primary     care clinics consisting primarily of Caucasian and African-American patients. The primary     outcome measurements will be the percentage change in LDL-C. Secondary outcomes will include     changes in total cholesterol, HDL-C, triglycerides, C-reactive protein, and lipoprotein     sub-particles. This will be the first known randomized clinical trial of policosanol in North     America.      The data derived from this pilot study regarding the lipid lowering effects of policosanol     will be used to support applications for further funding through institutions outside the     Carolinas Healthcare System including the National Institute of Health (NIH).      Specific Aim: To independently corroborate the lipid lowering effects of policosanol in a     small pilot study.   "
185390|NCT00272766|"     The purpose of this study is to evaluate the safety and effect on visual acuity of Macugen     (pegaptanib sodium) in patients with subfoveal choroidal neovascularization (CNV) secondary     to the ocular histoplasmosis syndrome (OHS).   "
184338|NCT00255229|"     Irinotecan (7-ethyl-10- {4(-1-piperidino)-1-piperidino} carbonyloxy camptothecin) is a     semisynthetic camptothecin derivative introduced in the 1980's. Irinotecan is a prodrug     metabolized by carboxylesterases to an active metabolite 7-ethyl-10-hydroxy-camptothecin     (SN38). SN38 exerts its cytotoxic effect by forming stable complexes with topoisomerase I and     DNA. These complexes collide with replication forks and cause breaks in DNA. Studies     substantiated irinotecan's activity in 5FU resistant colorectal cancer and led to its     approval for treatment of 5FU resistant colorectal cancer in the United States, Canada and     Europe.Colorectal cancer studies demonstrated that single agent irinotecan's dose limiting     toxicity was diarrhea occurring 5 to 6 days after its administration. High dose loperamide at     first occurrence of diarrhea has decreased the incidence of diarrhea but the incidence of     grade 3/4 diarrhea remains high at 28 to 40%.   "
186147|NCT00283621|"     To determine the percentage of patients and number of cycles in which a packed red blood cell     transfusion was administered due to anemia and in which antibiotics were administered due to     neutropenic fever.   "
184339|NCT00255242|"     Individuals with cystic fibrosis (CF) have persistent infection in the airways, which the     body attempts to fight by recruiting immune cells (neutrophils) to the lung. The immune     system and neutrophils are unable to completely kill the bacteria, and the response to the     infection leads to inflammation (swelling) of the airways and lung damage. Nitric oxide (NO)     has anti-bacterial and anti-inflammatory properties in the lung. NO production is decreased     in CF patients, and may contribute to the persistent infection and inflammation. Increasing     the production of NO in the airways of CF patients may help decrease this inflammation and     infection.      Rho GTPases are molecules in the cells that line the airways that decrease the protein that     makes nitric oxide (NOS). Rho proteins also increase inflammation in these cells. Rho     proteins are increased in CF cells, and may partially explain the low NO and high     inflammation seen in CF. Blocking the Rho protein in CF cells increases NOS, which can then     produce more NO. The Rho protein can be inhibited with a drug, simvastatin (Zocor®).     Simvastatin is used by millions of people to lower their cholesterol, is very safe, has few     side-effects and is approved for use in children greater than 10 years of age. We propose     that treating CF patients with simvastatin will increase NO produced (exhaled NO), and may     decrease airway inflammation.      If simvastatin has these expected effects in CF, it would be another drug that has potential     to become a new therapy to fight the debilitating lung damage of the disease.   "
184340|NCT00255255|"     This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation     b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS     and long acting β2-agonist (LABA) and/or other anti-asthmatic drugs.   "
184341|NCT00255268|"     To evaluate the efficacy, safety and survival of two treatment regimens: Continuous     Intermittent Maximum Androgen Blockade, using goserelin and bicalutamide in patients with     prostate cancer. Primary endpoint is time to progression. Fifteen patients will be evaluated.     QoL evaluation is also included.   "
184342|NCT00255281|"     The current study is designed to assess the efficacy and safety of iv AZD7009 in conversion     from AF   "
184343|NCT00255294|"     This study will evaluate the contraceptive effectiveness of cellulose sulfate vaginal gel in     preventing pregnancy when used for 6 months.   "
184344|NCT00255307|"     This is a randomized double-blind three-arm trial to evaluate two dosages of CVT-E002 against     placebo in pediatric upper respiratory tract infections (URTI). It is hypothesized that     CVT-E002 use at standard doses reduces the duration of URTI in children aged 3-12 years.   "
184345|NCT00255320|"     We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP     induced headache may be associated with dilatation of intra- and extracerebral blood vessels.     To test this hypothesis, we performed a double blind placebo controlled crossover study in     normal human volunteers and studied the effect on headache and cerebral as well as     hemodynamic parameters.   "
184346|NCT00255333|"     The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer     drug, are being studied in patients with solid tumors.   "
184347|NCT00255346|"     The goal of this clinical research study is to learn if dasatinib can help to control     myeloproliferative disorders. The safety and tolerability of dasatinib will also be studied.   "
184348|NCT00255359|"     The study will be a randomized, double blind, placebo controlled, dose rising study in     Interferon alpha (IFN-alpha) non-responder HCV infected patients or HCV patients who have     relapsed following IFN-alpha therapy. Eligible subjects must have compensated liver disease     and serum HCV RNA concentrations above 100,000 IU/mL at screening. The study will include     both a single dose period for the evaluation of acute toxicity and single dose     pharmacokinetics and a consecutive multi-dose period for the determination of longer-term     safety, multiple-dose pharmacokinetics and antiviral activity. The objectives of this study     are to evaluate the safety, tolerability, and antiviral activity of escalating single and     multiple doses of XTL 2125 in patients with chronic hepatitis C virus infection and to assess     the single- and multiple-dose pharmacokinetics of XTL 2125   "
184349|NCT00255372|"     The purpose of this study is to determine whether Forlax® is more effective than placebo in     relieving chronic constipation in children who may also suffer from soiling or faecal     incontinence.   "
184350|NCT00255385|"     The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or     with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and     improvement in growth and development.   "
184351|NCT00255398|"     Kidney Disease Biomarkers      Summary: This study will identify biomarkers (proteins and other molecules in the blood or     urine) that may help scientists predict what kidney disease a patient has and whether a given     patient would respond to particular therapies. The study will look for biomarkers in the     blood and urine of patients with various kidney diseases and study of the effects of     angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers     (ARB) on biomarkers. Blood and urine from healthy volunteers will be studied for comparison.      Healthy people and the following patients may be eligible for this study: adults with     diabetic nephropathy 18 years of age and older; children with newly diagnosed clinical     idiopathic nephrotic syndrome between 2 and 18 year of age; children and adults with     glomerular disease (minimal change disease, focal segmental glomerulosclerosis, or collapsing     glomerulopathy).      Participants undergo tests and procedures as follows:      Glomerular Disease: Adults with glomerular disease provide about four to six blood and urine     samples over the course of 6 to 12 months. The samples are collected at the time of regularly     scheduled visits for the NIH treatment protocol in which they are participating. Children     provide only blood samples.      Chronic Kidney Disease: Patients with chronic kidney disease provide a blood and urine sample     every 6 months for 3 years or more.      Angiotensin Antagonism: Patients with chronic kidney disease who are taking ACE inhibitors or     ARBs stop their medicines for 4 weeks, while those who are not taking ACE inhibitors or ARBs     begin one of the medicines. In general, patients just starting on the medications continue     them after the study is completed, since they are beneficial for chronic kidney disease.        -  Medication withdrawal group: Patients come to NIH for 2 successive days at the beginning          of the study for blood and urine tests (including one 24-hour urine collection) and to          receive iothalamate (a chemical used to measure kidney function). Iothalamate is          delivered over 24 hours through a needle placed in the abdomen (or elsewhere) via a pump          similar to pumps that some diabetics use to deliver insulin. Patients then stop taking          their ACE inhibitor or ARB medication. They monitor their blood pressure every day and          return to NIH after 1, 2 and 4 weeks for blood tests. During week 4, the iothalamate          infusion is repeated, and blood and urine samples are collected as at the beginning of          the study. Patients then resume taking their ACE inhibitor or ARB once a day with the          dose being increased at 2-week intervals. They come to NIH weekly after 1 week and then          every other week for blood tests. Four weeks after reaching the highest FDA-recommended          dose of medication tolerated, the iothalamate infusion and blood and urine collections          are repeated.        -  Medication induction group: At the beginning of the study, patients have the iothalamate          infusion and blood and urine collections described above and then begin to take either          an ACE inhibitor or ARB. The dose is increased after 2 weeks. Patients monitor their          blood pressure every day. After being on the highest dose for 4 weeks, patients repeat          the iothalamate infusion and blood and urine collections. The study is then complete and          they are provided a 2-month supply of medicine to take home.      Information is gathered on symptoms, treatments, and results of past laboratory tests of all     patients. Healthy volunteers provide blood and urine sample collections every month or every     other month for up to four collections to be used for biomarker studies and the screen for     common chronic diseases.   "
184352|NCT00255411|"     This study will explore how the mind and the brain work to cause movement symptoms or     seizures in people who do not have a recognized neurological or medical disorder. The study     includes a check for psychiatric disorders, symptoms and their severity; psychiatric and     personality questionnaires; and neuropsychological testing.      Normal, healthy volunteers, people who have movement symptoms not due to a brain or medical     disorder and people who have seizures not due to epilepsy may be eligible for this study. All     candidates must be 18 years of age or older.      All participants have a medical history, physical examination and psychological evaluation,     including completion of questionnaires. People with movement symptoms or seizures have a     symptoms evaluation.      Some participants also undergo neuropsychological testing, including questionnaires,     pen-and-paper or computerized tests, and motor tasks.   "
184353|NCT00255424|"     The study will evaluate the safety and efficacy of a new intravenously administered iron drug     to treat anemia in patients with chronic kidney disease who are not on dialysis.   "
184359|NCT00255502|"     This was a 52-week, multicenter, open-label study to determine the safety, tolerability and     pharmacokinetics of TOPROL-XL (metoprolol succinate) extended-release tablets (metoprolol     CR/XL) in hypertensive pediatric subjects. The study population included school age children     (age 6 to 12 years < Tanner Stage 3) and adolescents (> 12 years old or > Tanner Stage 3 to     16 years old) of both genders. Because response to some therapies in adult hypertension     appears to be different in black and non-black populations, the recruitment will have a     mixture of black and non-black subjects. Pharmacokinetic measurements were performed on a     subset of patients. Thirty subjects (15 subjects each in the 6 to 12 year age group and the     13 to 16 year age group) had a series of blood samples drawn. All subjects had a trough     plasma level taken 24 hours after the last dose of open-label metoprolol CR/XL (Visit 18)     with the exception of those subjects who completed Protocol 307B (16 week open-label     treatment).   "
184361|NCT00255528|"     This was a 4-week, multicenter, double-blind, placebo-controlled, randomized, parallel-group     study to determine the antihypertensive dose range, efficacy, safety and tolerability of     TOPROL-XL ® (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in     hypertensive pediatric subjects. The study population included school age children (age 6 to     < Tanner Stage 3) and adolescents (> Tanner Stage 3 to age 16) of both genders. No more than     50% of the randomized subjects could be adolescents (> Tanner Stage 3 to 16 years old). Since     response to some therapies in adult hypertension appears to be different in black and     non-black populations, recruitment was aimed at a mixture of black and non-black children.     The design included a 1-week screening period (for treatment naive subjects), a 1-week     single-blind placebo run-in period, and a 4-week double-blind treatment period. Eligible     subjects were randomized to the double-blind period with a once daily oral dose of metoprolol     CR/XL to one of three target doses: 0.2, 1.0 and 2.0 mg/kg, or placebo. Dosing was weight     adjusted. The dose range for this study was 12.5 to 200 mg daily. Subjects were closely     monitored and evaluated at the end of Weeks 1, 2, 3 and 4 during the double-blind treatment     period.   "
184362|NCT00255541|"     This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled     (glibenclamide) study of tesaglitazar in patients with type 2 diabetes, not adequately     controlled on diet and lifestyle advice alone during the run-in period. The study comprises a     6 week placebo single blind run in period followed by a 52-week double blind treatment period     and a 3-week follow-up period. Tesaglitazar and glibenclamide will be titrated to optimal     effect or highest tolerable dose during the first 12 weeks.   "
184363|NCT00255554|"     Subjects will receive six months of DBT, consisting of one 90-minute group and one 60-minute     individual session per week as well as telephone availability of the individual therapist.     Half the subjects will concurrently receive escitalopram while half will receive placebo, in     a randomized double-blind design.   "
184364|NCT00255567|"     The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21     days alone and SSG and PM as a combination course of 17 days in the treatment of patients     with VL.   "
184365|NCT00255580|"     The purpose of this study is to determine if medicinal cannabis (marijuana) is safe and     effective for treating pain in individuals with HIV-associated distal, sensory-predominant     polyneuropathy (DSPN).   "
184366|NCT00255593|"     Current strategies for the medical management of transplant patients are largely focused on     the prevention and treatment of T-lymphocyte mediated processes. However there is an     increasing evidence to suggest that B-lymphocytes have a role in the otherwise classic T-cell     mediated rejection of transplants by there ability to act as antigen presenting cells and     T-cell activators. Thus there is a significant medical need for effective therapies targeting     B cells of transplant patients.One such potential therapy would be to use rituximab, a     monoclonal antibody against B-cells in all renal transplant patients. In the present study     the efficacy and safety of prophylactic rituximab is studied.   "
184367|NCT00255606|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It     is not yet known which schedule of docetaxel and prednisone is more effective in treating     prostate cancer.      PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and     prednisone to compare how well they work in treating patients with metastatic prostate     cancer.   "
184368|NCT00255619|"     Apart from haemodialysis, continuous ambulatory peritoneal dialysis (CAPD) is another     effective therapy for end stage renal disease (ESRD). The Achilles heel of CAPD however is     peritonitis, which is a major cause of morbidity and mortality in CAPD patients. Advances in     connectology, such as the disconnect system, have resulted in reduced rate of peritonitis.     The disconnect system which incorporated a Y-connection allow contamination occurring at the     time of connection of the system to flush into the drainage bag thereby reducing the size of     microorganism innoculum entering the peritoneal cavity. In recent years, the twin bag system     where both the infusion and drainage bags are pre-attached to the Y tubing, has resulted in     further reduction in peritonitis rate.      Two different twin bags systems are being introduced into the MOH hospitals. They are Baxter     UltraBag® and Fresenius Andy·Disc®.      Even though both the systems are very similar, our own experience suggest that minor     variation in the connectology could translate into marked differences in the peritonitis     rate. In this multi centre, randomised controlled study, both the twin bag systems will be     evaluated to establish their equivalence with respect to the incidence of peritonitis and     technique failure.   "
184369|NCT00255645|"     This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24     months, in patients with type 2 diabetes after participation in the phaseII/III studies     GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined     laboratory or clinical findings, will have a 12-week post-treatment follow-up visit,     including laboratory evaluation and adverse event recording.   "
184913|NCT00257101|"     To test the effectiveness of a stepped-care intervention involving 2 stages: (1)     Self-Telemonitoring (STM) of blood pressure (BP) which uses a telephone transmission system     (2) Telephone-Based Nurse Case Management (NCM), provided by a commercially available     service.   "
184370|NCT00255658|"     This phase I trial is studying the side effects and best dose of temsirolimus when given     together with sorafenib in treating patients with unresectable or metastatic solid tumors.     Sorafenib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood     flow to the tumor. Giving sorafenib together with temsirolimus may kill more tumor cells.   "
184371|NCT00255671|"     RATIONALE: Learning about the side effects of stereotactic radiosurgery in patients with     brain tumors or other brain disorders may help doctors plan treatment and help patients live     more comfortably.      PURPOSE: This clinical trial is studying the acute side effects in patients who are     undergoing stereotactic radiosurgery for brain tumors or other brain disorders.   "
184400|NCT00256074|"     The purpose of this study is to assess the impact of different feeding solutions on patients     with breathing difficulty being supported by a breathing machine.      The aim of the study is to determine if high fat-low carbohydrate feeding reduces the carbon     dioxide production in patients with respiratory failure.   "
184372|NCT00255684|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and     radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the     growth of cancer cells. It also stops the patient's immune system from rejecting the donor's     stem cells. The donated stem cells may replace the patient's immune system and help destroy     any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from     a donor can also make an immune response against the body's normal cells. Giving cyclosporine     and mycophenolate mofetil after transplant may stop this from happening.      PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide     together with total-body irradiation followed by cyclosporine and mycophenolate mofetil works     in treating patients who are undergoing a donor umbilical cord blood transplant for     hematologic cancer.   "
184373|NCT00255697|"     RATIONALE: Studying quality-of-life in patients having cancer treatment and in their     caregivers may help identify the intermediate- and long-term effects of treatment on patients     with cancer and on their caregivers.      PURPOSE: This clinical trial is studying quality of life of older patients who are undergoing     treatment for cancer and of their family caregivers.   "
184374|NCT00255710|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy     before a donor bone marrow or stem cell transplant helps stop the growth of cancer cells. It     also stops the patient's immune system from rejecting the donor's stem cells. The donated     stem cells may replace the patient's immune system and help destroy any remaining cancer     cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also     make an immune response against the body's normal cells. Giving cyclophosphamide,     mycophenolate mofetil, and tacrolimus after transplant may stop this from happening.      PURPOSE: This phase I trial is studying cyclophosphamide and/or mycophenolate mofetil with or     without tacrolimus to see which is the best regimen in treating patients who are undergoing a     donor bone marrow or stem cell transplant for hematologic cancer.   "
184375|NCT00255723|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses     high-energy x-rays to kill cancer cells. Giving combination chemotherapy and radiation     therapy with an autologous stem cell transplant, using peripheral stem cells or bone marrow     from the patient, may allow more chemotherapy to be given so that more cancer cells are     killed. Giving combination chemotherapy together with radiation therapy before an autologous     stem cell transplant may be an effective treatment for Hodgkin's lymphoma.      PURPOSE: This phase II trial is studying how well combination chemotherapy and radiation     therapy work in treating patients who are undergoing an autologous stem cell transplant for     relapsed or refractory Hodgkin's lymphoma.   "
184376|NCT00255749|"     RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat     anemia caused by cancer and chemotherapy.      PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating     patients with anemia who are undergoing chemotherapy for cancer.   "
184377|NCT00255762|"     This phase II trial is studying how well giving carboplatin and paclitaxel together with     bevacizumab works in treating patients with stage IV melanoma that cannot be removed by     surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and paclitaxel     together with bevacizumab may kill more tumor cells.   "
184378|NCT00255775|"     RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from     forming, growing, or coming back. The use of broccoli sprout extract may prevent lung cancer.      PURPOSE: This clinical trial is studying how well broccoli sprout extract works in preventing     lung cancer in smokers.   "
184379|NCT00255788|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor.      PURPOSE: This randomized phase II trial is studying two different schedules of everolimus to     see how well they work in treating patients with recurrent or metastatic breast cancer.   "
184380|NCT00255801|"     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and bexarotene, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Bexarotene may also cause cutaneous T-cell lymphoma cells to look more     like normal cells, and to grow and spread more slowly. Giving liposomal doxorubicin followed     by bexarotene may be an effective treatment for cutaneous T-cell lymphoma.      PURPOSE: This phase II trial is studying how well giving liposomal doxorubicin followed by     bexarotene works in treating patients with cutaneous T-cell lymphoma.   "
184381|NCT00255814|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy     in treating patients with liver metastases.   "
184398|NCT00256048|"     The purpose of this study is to determine if naso-jejunal feeding (feeding beyond the     stomach) improves the efficacy of enteral feeding (feeding into the gut) in critically ill     patients.      The study hypothesis is that in patients who fail to establish enteral feeding via the     nasogastric route, introduction of nasojejunal feeding will lead to more effective enteral     feeding than the current regime involving staged introduction of promotility agents.   "
184401|NCT00256087|"     To assess the effect of addition of probiotic Lactobacilli to standard enteral feeding on     infection rates and feeding efficacy in critically ill patients.      The study hypothesis is that critically ill patients who receive the addition of probiotic     lactobacilli to the enteral feed will lead to a reduced rate of hospital acquired infections.      The null hypothesis is that there will be no significant difference in the rate of hospital     acquired infection in critically ill patients who receive enteral feeding with or without the     addition of probiotic Lactobacilli.   "
184402|NCT00256100|"     The purpose of this project is to assess the safety and effectiveness of fondaparinux, a new     drug to prevent blood clotting in the continuous dialysis machine used in intensive care     patients who have kidney failure.   "
184382|NCT00255827|"     This 2-phase study will determine the safety of treating patients with pancreatic cancer with     the genetically engineered HyperAcute-Pancreatic cancer vaccine. It will establish the proper     vaccine dose and will examine side effects and potential benefits of the treatment. The     vaccine contains killed pancreatic cancer cells containing a mouse gene that causes the     production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the     immune response to the foreign substance will stimulate the immune system to attack the     patient's own cancer cells that have similar proteins without this sugar pattern, causing the     tumor to remain stable or shrink.      Patients 18 years of age or older with pancreatic cancer that has been surgically resected     may be eligible for this study. Candidates will be screened with medical history and physical     examination, blood tests, urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound     scans may be obtained if needed.      Participants will receive twelve vaccinations two weeks apart from each other. The vaccines     will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase     I of the study will treat successive groups of patients with increasing numbers of the     vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase     II will look for any beneficial effects of the vaccine given at the highest dose found to be     safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine     treatment. In addition, patient follow-up visits will be scheduled every 2 months for the     remaining first year (6 months) after vaccination and then every 3 months for the next 2     years for the following tests and procedures to evaluate treatment response and side effects:      Medical history and physical examination Blood tests X-rays and various scans (nuclear     medicine/CT/MRI) FACT-Hep Assessment questionnaire to measure the impact of treatment on the     patient's general well-being. The questionnaire is administered before beginning treatment,     monthly during treatment, and during follow-up visits after completing the treatment. It     includes questions on the severity of pancreatic cancer symptoms and the ability to perform     normal activities of daily life.   "
184383|NCT00255840|"     The purpose of this study is to determine the effectiveness of several anti-HIV treatment     strategies in resource-poor South African communities. The strategies being studied are using     specially trained doctors or nurses to administer HIV care.   "
184384|NCT00255866|"     This study will develop a treatment program to reduce mood and behavior problems in assisted     living residents who have dementia.   "
184385|NCT00255879|"     This study will assess the risk of experiencing tardive dyskinesia and other movement     disturbances associated with three atypical antipsychotic drugs among middle-aged and elderly     psychiatric patients.   "
184386|NCT00255892|"     This study is an exploratory qualitative investigation of the challenges, strengths, and     needed areas of support associated with receiving an HIV diagnosis among youth living with     HIV. Qualitative interviews will be conducted with health care providers who work with     adolescents living with HIV and focus groups will be conducted with adolescents who are     living with HIV (ages 16-24). One third of the focus groups will be conducted in Spanish.     Findings from this study will be used to create an outline and development plan for a     culturally-sensitive and developmentally appropriate intervention (or set of interventions)     for youth recently diagnosed with HIV.   "
184387|NCT00255905|"     This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating     insomnia symptoms that are secondary to depression. This study will also determine how long     the benefits of CBT will last and how the recurrence of insomnia is associated with the onset     of new depressive episodes.   "
184388|NCT00255918|"     This study will determine the effectiveness of a drug, dimethoxbenzylidene anabaseine, in     producing beneficial effects similar to that of nicotine in individuals with schizophrenia.   "
184389|NCT00255931|"     The purpose of this study is to determine the effect of biofeedback-relaxation combined with     cognitive behavioral therapy on clinical, physical and psychological outcomes in patients     with heart failure.   "
184390|NCT00255944|"     This study will evaluate the effectiveness of a tailored interactive online risk reduction     program versus a standard online risk reduction program in reducing the risk of STD infection     in young adults.   "
184391|NCT00255957|"     The use of HES has been found clinically to improve patients with stroke if administered     within a window period by means of hemodilution to improve rehology. We propose to see the     effects of long term administraion of HES in the amounts required for treating stroke     patients and study the effects on the kinetics of HES, its effects on coagulation and     hemorheology.   "
184392|NCT00255970|"     The purpose of this research study was to determine whether treatment with the bone grafting     material Regenafil was as effective as the standard treatment using demineralized freeze     dried bone allograft (DFDBA). Regenafil is demineralized freeze dried bone in a special gel     form.   "
184393|NCT00255983|"     Identifying the role of antibiotics in the treatment of subjects with a microbiologically     documented acute exacerbation of chronic bronchitis (AECB) is the purpose of this clinical     trial. The trial has been designed to evaluate the efficacy and safety of faropenem medoxomil     versus placebo in the treatment of subjects with microbiologically documented AECB.   "
184394|NCT00255996|"     Evaluation of linezolid pk profile in burns patients   "
184395|NCT00256009|"     A randomize trial: expectation or evacuatio uteri for the treatment after late abortion   "
184396|NCT00256022|"     The primary hypothesis for the study is that pre-operative prophylactic probiotic     Lactobacilli tablets will reduce the severity and incidence of endotoxin rise in post     cardiopulmonary bypass in cardiac surgery patients.      Endotoxins are large heat stable lipopolysaccharides, which are found in the cell wall of     gram negative bacteria. It has been assumed that the intestinal bacteria are the primary     source of the plasma endotoxin in cardiac surgery patients.Lactobacilli have been reported as     effective in counteracting gram negative bacteria in the gut.Thus Lactobacilli may be     effective in reducing the endotoxin rise associated with cardiopulmonary bypass, which may     potentially reduce the incidence of the syndrome of generalised inflammation and low systemic     vascular resistance post cardiopulmonary bypass.   "
184397|NCT00256035|"     In recent years, medical research into the cause and progression of heart disease due to     narrowing and blockage of blood vessels to the heart muscle has improved the understanding of     ischemic heart disease. It is now accepted that both the development and later progression     with sudden blockage of blood vessels are associated with inflammation, although it remains     unknown exactly what triggers this inflammatory process. It is possible that new blood tests     which measure markers of inflammation in the bloodstream may be useful to help identify     patients at risk of heart damage and assess response to treatment.      The study plans to assess a new blood test for a known marker of inflammation (IL-4) in     patients with heart disease.      The hypothesis of this study is that, the cytokine, IL-4, measured by a new assay, is     abnormally elevated in the blood of patients with coronary artery disease.      Also hypothesized is that the degree of abnormality of blood IL-4, is related to important     clinical events in such patients, including severity of disease, acute complications, and     treatment.   "
184404|NCT00256126|"     The study aims at identifying the predictive markers after one month of Saizen therapy in     Growth Hormone Deficiency (GHD) and Turner Syndrome children. The study will recruit     approximately 360 children in several countries worldwide. The study lasts for about the     first one month of daily growth hormone treatment. There will be three clinic visits during     the month of the study. There is an initial visit, then a visit before growth hormone     treatment starts and finally a visit at the fourth week of treatment. The study requires two     additional blood tests to a regular Saizen treatment follow-up. One sample is taken before     growth hormone injections start and one additional blood sample is taken at the fourth week     of treatment.   "
184405|NCT00256139|"     A multicentre, randomised, double blind, placebo controlled phase III study of subcutaneously     administered Raptiva in the treatment of patients with moderate to severe psoriasis   "
184406|NCT00256152|"     In patients with a standard indication for pacing and no previous history of AF, detection of     Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism.      Overdrive atrial pacing with the AF Suppression algorithm will reduce the risk of symptomatic     AF in patients with standard indication for pacing and no previous history of AF.   "
184407|NCT00256165|"     The purpose of this study is to obtain data regarding the left ventricular mass (LVM)     regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing     LVM regression measured with magnetic resonance imaging (MRI) to LVM regression measured with     echocardiography (2-dimensional [2D] mandatory; 3-dimensional [3D] in sites where the     technology is available).   "
184408|NCT00256178|"     The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily     (QD), taken with simvastatin on cholesterol levels in subjects with primary dyslipidemia   "
184409|NCT00256191|"     Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is     synthetically manufactured from naturally occurring taxanes extracted from yew starting     material. The synthesis involves modification to the taxane side chain to overcome multidrug     resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose     escalation, sequential group, Phase 1 study evaluating the intravenous administration of TPI     287 on an every 21 day cycle.   "
184410|NCT00256204|"     A 2 phase study to evaluate disease progression in Parkinson's disease patients taking     rasagiline   "
184411|NCT00256217|"     Breast cancer is one of the most common cancers seriously afflicting women in the United     States. Of the one million incident cases that are reported annually there are approximately     193,000 new cases of breast cancer (Greenlee, 2001). Although significant advances have been     made both in early detection and treatment of breast cancer, the impact of these on reduction     in mortality has been modest (Peta, 2000). Furthermore, despite data implicating diet and     other environmental risk factors, no lifestyle changes have yet been shown to significantly     reduce the risk of breast cancer. Therefore, chemoprevention of breast cancer is a worthwhile     approach to reduce the incidence of breast cancer.      There is every reason to believe that a detailed understanding of the initiation, promotion     and growth of breast cancer will ultimately provide a rational strategy upon which to base     prevention strategies. While the pathways of breast cancer development are not yet fully     understood, a role for estrogens in breast cancer etiology has been well established.      While many pathways are involved in breast cancer etiology, including loss of tumor     suppressor function by p53 or BRCA1 and gain of HER2 oncogene expression, their exact role in     an individual patient's cancer development may vary.      Therefore, it may be advantageous to focus on a chemoprevention strategy that may have a more     uniform impact on breast cancer development, such as estrogen exposure. Estrogen and its     metabolites, both in the circulation and locally synthesized in the breast, are important in     the pathogenesis of breast cancer. High levels of circulating estrogen in postmenopausal     women have been associated with an increased risk of breast cancer (Clemons, 2001).     Furthermore, local estrogen synthesis, i.e. aromatase activity, in the breast may also be     important in the development of breast cancer.   "
184412|NCT00256230|"     Melanoma remains a malignancy that is largely resistant to chemotherapy. Metastatic disease     responds poorly to the treatments used today with only 2 out of 30 drugs tested, DTIC and     nitrosoureas, showing response rates greater than 10%, and complete responses are rare.     DTIC-based regimen has been recognized as a standard chemotherapy for advanced melanoma, and     temozolomide demonstrated efficacy equal to that of DTIC and is an oral alternative agent     that also crosses the blood brain barrier. Randomized phase III trials have shown no survival     benefit of adding other agents (cisplatin, BCNU, and tamoxifen). Biochemotherapy is being     developed extensively with moderate improvement in the responsive rate (approximately 50%)     and is under evaluation in randomized trial to identify whether there is survival benefit to     this strategy, compared with chemotherapy alone. Recently, a randomized phase III study     comparing chemotherapy (cisplatin, dacarbazine, and tamoxifen) with biochemotherapy (the same     chemotherapy regimen plus high-dose IL-2 and interferon alfa) have shown 44% response rate     for biochemotherapy vs. 27% for chemotherapy. However, the tendency toward an increased     response rate in patients who received biochemotherapy did not translate into an increase in     overall survival, and there was, in fact, a trend for a survival advantage in patients     receiving chemotherapy alone (median survival: 10.7 vs 15.8 months). New agents (or     combinations) need to be developed for this refractory malignancy.      The purpose of this study is to determine the response rate and evaluate the toxicity of     disulfiram (DSF) in the treatment of Stage IV melanoma.      The advantages of using DSF in this phase I/II trial are the following:        -  DSF has been used as a drug for many years for the treatment of alcoholism. Its          mechanism, pharmacokinetics, toxicity/tolerable dose are well known, and this drug is          relatively non-toxic by itself at therapeutic dose. Doses of greater than 3000mg/m2 can          cause reversible confusion.        -  DSF can be taken orally; therefore, it is convenient to administer.        -  DSF can penetrate the blood-brain barrier (unlike dacarbazine and many other          chemotherapy agents); therefore, it might have an active effect on CNS metastasis.      This study is designed to include women and minorities, but is not designed to measure     differences of intervention effect.   "
184413|NCT00256243|"     Neoadjuvant chemotherapy, also termed primary, induction, or preoperative chemotherapy, is     defined as chemotherapy administered before locoregional treatment. It was first used in     locally advanced breast cancer 30 years ago. Classically, these tumors were treated with     radical surgery and/or radiotherapy. However, despite this aggressive local therapy, most     patients relapsed with distant metastases and eventually died. The aim of neoadjuvant therapy     is to reduce the tumor volume in patients before surgical resection, thus increasing the     likelihood of breast conservation. More recently, neoadjuvant therapy has been studied as a     way of testing the relevance of biological markers in predicting disease outcome.      At least six randomized trials have compared survival in patients managed with either the     neoadjuvant or adjuvant approaches. Two of the smaller trials suggested a survival advantage     for patients treated with neoadjuvant chemotherapy. Other studies, including the largest     trial (1,523 patients) run by the NSABP, found no differences in disease-free and overall     survival.      Induction of a Microscopic path clinical response (pCR) should be one of the primary goals of     neoadjuvant therapy because patients with no evidence of tumor cells in breast and lymph     nodes after treatment may have a longer disease-free and overall survival.      Biweekly and weekly regimens may enhance dose intensity by minimizing re-growth of cells     between cycles of treatment. In fact, dose dense regimens have even shown a survival benefit     in an adjuvant setting in lymph node positive breast cancer, made possible with use of     granulocyte colony-stimulating factor (G-CSF). There is as yet no standard best neoadjuvant     treatment. Generally patients receive AC (NSABP 14) on 3-weekly regimens in neoadjuvant     setting. In addition, incorporation of taxanes on a 3 weekly schedule has resulted in     statistically higher pathological clinical response (CR). More recently, weekly paclitaxel     regimens have reported increased pathological responses compared to 3 weekly taxane regimens.     Carboplatin has also emerged as an effective agent in the treatment of metastatic breast     cancer. Moreover, the combination of carboplatin and paclitaxel has been found to be     synergistic both in three-weekly regimens and weekly regimens. In fact, combination of     carboplatin, paclitaxel and herceptin has demonstrated a survival advantage over paclitaxel     and herceptin alone. The Phase III study, the preliminary results of which were presented at     the San Antonio Breast Cancer Symposium, show that the addition of carboplatin to herceptin     and paclitaxel resulted in a six-month improvement in the time it took for the disease to     progress, compared to the standard herceptin and paclitaxel regimen. The study found median     survival in the herceptin and paclitaxel arm was 33.5 months, while the group receiving the     tripartite therapy had yet to reach that point after 36 months of follow-up. Furthermore, the     weekly regimens of these drugs have been found to have significantly improved tolerability     over three weekly regimens. Therefore, we propose to use 4 cycles of AC q 2 weeks, as used in     the dose dense adjuvant study with Granulocyte-macrophage colony-stimulating factor (GM-CSF)     support on days 3-9 of the cycle. After the completion of AC we plan to administer paclitaxel     and carboplatin weekly for a total of 12 doses with one week rest after every 3 weeks of     treatment over 12 weeks. Patients who are her-2 overexpressors by FISH will also receive     Trastuzumab with weekly carboplatin and paclitaxel as the combination TC±H has been found to     be synergistic in advanced breast cancer with improved clinical outcome.      In a separate trial, GM-CSF was used in breast cancer patients treated with adriamycin based     chemotherapy as the preferred growth factor in a neoadjuvant setting. The initial results are     suggestive of improved survival of breast cancer patients given 6 versus 5 versus 4 cycles of     chemotherapy with GM-CSF support. Higher dendritic cell (DC) trafficking showed a trend     toward improved survival. Moreover, intrapatient comparison before and after treatment showed     that the percentage of S100+ DC significantly increased over the course of GM-CSF treatment.     The results form the basis of current hypothesis that the primary tumor may be an in vivo     antigenic stimulus for dendritic cell trafficking, and that the combination of prolonged     neoadjuvant chemotherapy with GM-CSF induced immune enhancement may contribute to better     tumor control and better survival.   "
184414|NCT00256256|"     Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence     world wide with an increased risk of myocardial infarction and stroke. GLP-1 has convincing     effects on the high glucose levels in type 2 diabetic patients and is well tolerated. New     animal studies indicate a protective effect of GLP-1 in the brain and the heart. The     mechanism behind this is yet not known.      The study hypothesis is that GLP-1 will stimulate glucose-uptake in the brain and heart     independent of insulin and thereby exert its protective effects.   "
184415|NCT00256269|"     The combination of cisplatin and irinotecan has significant anti-tumor activity in esophageal     cancer. Oxaliplatin has been shown to have activity in combination with 5 FU and radiation in     treatment of locally advanced esophageal cancer. Oxaliplatin also has better side effects     profile than cisplatin and may be able to overcome tumors that have developed cisplatin     resistance. The standard treatment of locally advanced esophageal cancer has been cisplatin,     5FU and radiation followed by possible esophagectomy. However, a large portion of these     patients will relapse and the tumor may develop resistance to cisplatin and/or the cumulative     toxicity from previous treatment forbids the use of cisplatin again. Weekly combination of     oxaliplatin and irinotecan has been shown to be active and well tolerated in elderly     population with refractory colorectal cancer. Therefore, we propose this phase II trial of a     weekly oxaliplatin and irinotecan to test the effectiveness and the tolerability of this     regimen in metastatic and/or recurrent esophageal cancer.   "
186197|NCT00284271|"     This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2)     toxicity, overall response and FFTF.   "
184416|NCT00256282|"     Annually in the U.S. there is an estimated 40,000 new cases of malignant melanoma and 7000     deaths. This disease is becoming more common with its incidence increasing at a more rapid     rate in the past decade than that of any other cancer except lung cancer in women. Metastatic     disease responds poorly to the usual treatments with only 2 out of 30 drugs tested, DTIC and     nitrosoureas, showing response rates greater than 10%. Complete responses are rare.      Metastatic melanoma is a disease with few therapeutic options. Multi-agent chemotherapy with     cisplatin (CDDP), Dacarbazine (DTIC), Carmustine (BCNU), with or without Tamoxifen, offers a     20% response rate but has failed to consistently demonstrate a significant improvement in     overall survival (OS) or disease-free survival (DFS) when compared to a single agent DTIC.      Recently, investigators, in an effort to combine the activity of biologic response modifiers     with chemotherapy, have developed combination biochemotherapy for metastatic melanoma. Legha     et al reported an overall objective response rate of 64% with a 5-day biochemotherapy     regimen. O'Day et al reported similar results (overall response rate of 57%) using a modified     5-day biochemotherapy regimen.      The above regimens all have significant toxicities and modest response rates. Clearly, more     effective less toxic regimens are needed.      Vinorelbine tartrate (Navelbine) and Docetaxel (Taxotere) have both shown activity against     melanoma. Additionally, the combination of both drugs has shown enhanced activity against     melanoma.   "
184417|NCT00250510|"     The purpose of this study is to simulate what would occur if insurance reimbursement became     available for obesity treatment but required that the individual meet defined performance     milestones.   "
184418|NCT00250523|"     The purpose of this research study is to gather clinical and biologic information from     severely injured patients to better understand and characterize the host response to injury     and inflammation across several domains. This information may improve outcome prediction,     improve clinical treatment of injured patients, and permit the construction of non-biologic     computerized models of illness that can be utilized to represent the host response in future     research efforts. This study is designed as the calibration of a mathematical model of this     response with predictive capabilities.      The central hypothesis governing this study is that adaptive immune elements are crucial to     determining the outcome of complex inflammatory scenarios. We propose to test these     hypotheses in the following interrelated Specific Aims:      Specific Aim 1: To develop a robust mathematical model describing trauma/hemorrhage-induced     inflammation in humans, its pathologic consequences, and possible therapies.      Specific Aim 2: To translate the mathematical model to humans and create software aimed at     individualized clinical decision-making.      Specific Aim 3: To determine the prevalence of an IL-1 receptor-associated kinase (IRAK-1)     variant haplotype located on the X-chromosome in an injured population, and to characterize     differences in the pro-inflammatory response across gender, relative to the IRAK-1 haplotype.      Specific Aim 4: To determine if increased arginase activity previously observed in isolated     peripheral blood mononuclear cells of trauma patients is a consequence of the presence of     contaminating activated granulocytes or a particular subset of an arginase positive monocyte     subset.   "
184419|NCT00256295|"     The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors     including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and     lung. In the last study which utilized days 1 and 8 gemcitabine 1000 mg/m2 and days 1 and 8     oxaliplatin 65 mg/m2 in poor prognosis lung cancer patients (PS 1-3) the response rate was     16% with no incidence of febrile neutropenia.      Toxicity is a crucial consideration when designing regimens intended for palliation.     Toxicities associated with cisplatin can make it difficult to use in patients with Head and     Neck Cancer (HNC), many of whom are elderly and have comorbidities. In addition, many     patients with metastatic HNC have previously received cisplatin during neoadjuvant/adjuvant     therapy, or as part of their primary chemoradiation treatment. When these patients recur, it     is possible their tumors have innate or acquired cisplatin resistance. Oxaliplatin is likely     to be better tolerated than cisplatin containing regimens, especially with regards to     neurotoxicity. Gemcitabine has shown promising activity as a single agent and in combination     chemotherapy in the first line treatment of patients with HNC. A combination chemotherapy     regimen using oxaliplatin and gemcitabine administered once every week is logical and worth     exploring in patients with metastatic and recurrent head and neck cancer to improve the     toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy     regimen.   "
184420|NCT00256308|"     Oxaliplatin-containing regimens have been safely and successfully used in combination with     concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. The     Lyon R0-04 phase II trial utilized the combination of Oxaliplatin, infusional 5FU and     radiation in the treatment of rectal cancer. A total of 40 operable subjects were entered     onto the study. Radiotherapy was delivered with A three-field technique to a dose of 50 Gy     (total dose) over 5 weeks with a concomitant boost approach. Two cycles of chemotherapy were     given synchronously on weeks 1 and 5, with Oxaliplatin 130 mg/m2 in day 1 followed by     continuous infusion of fluorouracil 350 mg/mg2 and L-folinic acid 100mg/m2 for 5 days.     Surgery was planned 5 weeks later. All subjects completed treatment without modification     except one who experience grade 3-4 toxicity. Grade 3 toxicity was seen in seven subjects.     Surgery was performed in all subjects after a mean interval time of 5 weeks. An objective     clinical response was seen in 30 subjects (75%). Sphincter-saving surgery was possible in 26     subjects. No postoperative deaths occurred. In four subjects (10%), a reoperation was     necessary (anastomotic fistula, n=2; pelvic abscess, n=2). In six cases the operative     specimen was sterilized (15%), and in 12 cases (30%), only few residual cells were detected.     Such a combined preoperative chemoradiotherapy and Oxaliplatin-containing regimen is well     tolerated with no increase surgical toxicity. The good response rate observed warrants its     use in further clinical trials.      The combination of oxaliplatin, 5FU, and radiation also have been used in a Phase I/II trial     in esophageal cancer. In this particular trial, eligibility included therapeutically naïve     esophageal cancer subjects with clinical disease stages II to IV. Initial doses and schedules     for cycle 1 consisted of Oxaliplatin 85 mg/m2 on days 1, 15, and 29; continuous infusion of     5-FU 180 mg/m2 for 24 hours for 35 days; and RT 1.8 Gy in 28 fractions starting on day 8. At     completion of cycle 1, eligible subjects could undergo an operation or begin cycle 2 without     RT. Postoperative subjects were eligible for cycle 2. Stage IV subjects were allowed three     cycles in the absence of disease progression. 38 subjects were treated (22 stage IV, 16 stage     II-III). 38 eligible subjects received therapy: 22 non-invasively staged as IV and 16     non-invasively staged as IV and 16 non-invasively staged as II and III. 36 subjects completed     cycle 1, 29 subjects started cycle 2, and 24 subjects completed cycle 2. The     combined-modality therapy was well tolerated, but dose limiting toxicity (DLT) prevented     Oxaliplatin and 5-FU escalation. No grade 4 hematologic toxicity was noted. Eleven grade 3     and two grade 4 clinical toxicities were noted in eight subjects. After cycle 1, 29 subjects     (81%) had no cancer in the esophageal mucosa. 13 subjects underwent an operation with intent     to resect the esophagus and 5 subjects (38%) exhibited pathologic complete responses. There     was no surgical mortality. Only 1 subject developed post-operative tracheosphageal fistula.      The results of these trials described above indicated that combination of oxaliplatin and     radiation is safe and efficacious and dose not compromise surgical wound healing, repair and     clinical outcome.   "
184465|NCT00257543|"     We hope to gain valuable information about the safety, success of engraftment, and rates of     complications using alternate donor transplantation for children with severe SCD. Crucial     information will be also collected about late effects from alternate donor BMT sickle cell,     providing valuable information to clinicians and families making decisions among     interventions for children with severe sickle cell disease. If successful, alternate donor     transplantation in this setting could pave the way to offering curative treatment to many     more patients with severe SCD.   "
184421|NCT00256321|"     Gastric cancer is the second most common neoplasm in the world. Early diagnosis and surgical     resection improve the survival and the chance of cure. Unfortunately, majority of cases are     diagnosed at advanced stage, with only 20% of the patients presenting with localized disease.     The five-year survival for gastric cancer of all stages remains at a dismal 8%. Chemotherapy     has been used for advanced gastric cancer but with unsatisfactory results. Therefore, new     approaches are needed for these patients. Among the newer chemotherapy regimens for advanced     gastric cancer include a combination of oral 5FU-based compound called Capecitabine(Xeloda)     and Oxaliplatin. A few phase II studies suggest that the combination regimen is active with     overall response rates ranging 30-40%. Several preclinical and clinical studies have shown     that the expression of cyclooxygenase enzyme II(COX-2) is upregulated in many pre-neoplastic     and neoplastic lesions. Furthermore, there appears to be an association with the     overexpression of Cox-2 and the invasiveness of cancer and prognosis. Finally, preclinical     and clinical studies suggest selective Cox-2 inhibitors can induce apoptosis in gastric     cancer cells and retard tumor progression. Therefore, there is a strong rationale for the     combination of a selective Cox-2 inhibitor, Celecoxib, with Capecitabine and Oxaliplatin in a     therapeutic phase II trial for patients with advanced or recurrent gastric cancer.   "
186198|NCT00284284|"     Comparison of the added value of a rehabilitation brace to standard rehabilitation by     physiotherapy   "
184422|NCT00256334|"     Resveratrol is purported to possess cancer preventive activity, especially for colon cancer,     though its mechanisms of action are not well defined. Resveratrol is found in the skin of     grapes and has anti-oxidative and pro-apoptotic effects on cancer cell lines in vitro. The     main dietary sources of resveratrol are grapes, grape products, and red wine, and small     amounts may be found in mulberries. A prior report and compelling preliminary data from our     laboratory suggest that resveratrol modulates Wnt signaling, a signaling pathway which is     activated in over 85% of colon cancers. In this proposal, studies were performed to define     the actions of resveratrol on the Wnt signaling pathway in a clinical trial in which patients     with colon cancer received treatment with Resveratrol, and correlative laboratory studies     examined its effects directly on colon cancer and normal colonic mucosa. These studies     provided data on the mechanisms of resveratrol action and provided a foundation for future     prevention trials, correlative studies and therapeutic clinical research with this agent.   "
184423|NCT00256347|"     30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a     screening/orientation session. The next 5 visits will be (full day) outpatient sessions     taking place Monday through Friday during one week. All full day visits will be drug     administration sessions with subjects randomized to one of two groups. The primary purpose is     to investigate the time course of development of analgesic tolerance (loss of pain relieving     effect) to morphine on experimentally produced skin tenderness in healthy volunteers.   "
184424|NCT00256360|"     The rationale of this randomized phase II study is to investigate the feasibility of     sequenced densified FEC and docetaxel based regimens in patients with primary operable     high-risk breast cancer. Several phase III and phase II clinical trials showed the benefits     of dose-dense therapy (Q2W) over conventional treatment in breast cancer, lymphoma and SCLC.     The aim of the study is also to demonstrate that further shortening of treatment interval     from 14 days to 10-11 days in FEC regimen is feasible and will not compromise patient's     safety. The results of this randomized phase II study should serve as a basis for follow-up     randomized phase III trial comparing conventional versus densified sequential FEC and     docetaxel based regimens.   "
184425|NCT00256373|"     Rheumatologists are discussing, whether rehabilitation of patients with low back pain (LBP)     can be improved. At present patients with LBP start treatment as soon as possible, this also     applies for patients with chronic low back pain (CLBP) - pain lasting over 12 weeks. At     Glostrup University Hospital department of Physical Medicine/rheumatology we use a method     (method A) where an interdisciplinary team gives the patients a treatment composed of various     topics. This includes among other things education, physical team training, exercises in     swimming pool, stretching exercises, and occupational therapy. A different method (method B)     originates from the Rehabilitation centre in Karlslunde led by Teddy Oefeldt. Here they focus     strictly on dynamic training of muscles in the back and the buttocks. A therapist, who in the     beginning partly carries the patient through the exercises, assists this training.      In both methods, individually considerations are taken, but to a greater extend in method B.     The treatment will extend over a three months period.      A few earlier investigations have compared these two methods, but they have not been     systematized to such a degree, that they gave any final conclusions. Therefore, we     initialized an investigation including a larger number of patients, where the two methods are     compared from the results the patients achieve after 3, 6, 12 and 24 months.      286 consecutive patients were included and randomized to one of the two methods. Those, who     did not wish to participate in the investigation, were treated according to the department’s     normal procedure (Method A)   "
184426|NCT00256386|"     Errors and preventable adverse events associated with medication prescription and dispensing     are common, and the difference between guideline recommendations and the actual frequency of     laboratory monitoring is substantial. This study evaluates three interventions to improve     laboratory monitoring at initiation of medication therapy: an electronic medical record     reminder to the prescribing clinician (EMR), an automated voice message to the patient (AVM),     and a pharmacy team outreach (Pharmacy) compared to usual care (UC).   "
184427|NCT00256399|"     Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in     males with BPH and ED.   "
184428|NCT00256412|"     This is a research study to determine whether omega-3 fatty acid supplementation, when taken     with the antidepressant medication escitalopram (Lexapro), helps to improve depressive     symptoms in individuals who have major depressive disorder (MDD).      Omega-3 fatty acids are found in foods including walnuts, some fruits and vegetables, and     coldwater fish such as herring, mackerel, sturgeon, and anchovies.   "
184429|NCT00256425|"     The purpose of this study is to determine whether cognitive rehabilitation is effective in     patients with gliomas (brain tumour), by comparing direct and follow-up neuropsychological     functioning and quality of life of the experimental group to the control group.   "
184430|NCT00256438|"     Transcranial direct current stimulation (tDCS)is a non invasive technique which uses a very     weak current to change excitability in targeted regions of the brain. Early studies suggest     that it has antidepressant properties. This study will test the safety and efficacy of tDCS     as a treatment for depression.   "
184431|NCT00256451|"     The purpose of the study is to understand the relationship between what an individual     inherited from their family (genetics), how they respond and feel after drinking alcohol, and     how they respond to pre-treatment with naltrexone, a medication that blocks some of the     effects of alcohol and is approved for the treatment of alcoholism. The investigators are     conducting this study on those of African descent because there is almost no research focused     on this group and the association with genetics. The investigators seek to enroll 40 people     in the study. Participation will consist of 4 different alcohol challenge sessions. Each     session will be separated by at least 10 days. In total, there will be four challenge     sessions.   "
184472|NCT00257634|"     The purpose of this project is to compare different treatment options for lateral     epicondylitis. Lateral epicondylitis is a pain condition involving extensor muscles fo the     forearm originating from the lateral epicondyle. Controversy exists regarding the method of     delivering pain relief so that conditioning and strengthening can be initiated and progress     appropriately. Our hypothesis is that the steady even delivery via iontophoresis (compared to     injection will provide better pain control and allow physical therapy to progress more     effectively.   "
186199|NCT00284297|"     Follow-up of patients who underwent a knee arthrodesis with different types of intramedullary     nails.   "
184432|NCT00256464|"     The principal aim of this project is to conduct a Randomized Controlled Trial (RCT) to     examine whether adding a twelve-session Multi-Component Yoga Intervention (MCYI) to the     treatment regimen of Australian Vietnam Veterans suffering chronic Posttraumatic Stress     Disorder (PTSD) leads to a significantly greater clinical improvement than conventional     psychiatric treatment alone. Include 12 sessions with each session 3 hours duration- 4 days     per week for 3 weeks i.e. total of 36 hours. The Multi-Component Yoga Intervention (MCYI)     consisting of specific poses, breathing techniques, information about yoga techniques and     practices, group processes, psychoeducation, relaxation procedures and meditation techniques     in Vietnam War Veterans with chronic Posttraumatic Stress Disorder (PTSD) resistant to     treatment has been developed. This project aims to evaluate MCYI through RCT method.      It is hypothesised that Yoga augmentation will lead to: (1) reduced symptoms of PTSD and     Depression; and (2) reduced alcohol intake. A secondary aim of the proposed RCT is to     evaluate putative mediating variables. Benefits include that it is low cost and easy to     apply. Done at home, non threatening and additional to standard psychiatric treatment for     PTSD.   "
184433|NCT00256477|"     The main aim of this project is to evaluate the use of a specific Yoga technique of     controlled breathing in Vietnam War Veterans with chronic posttraumatic stress disorder. This     method is currently the subject of a United States grant application to formally test     American War Veterans from Afghanistan and Iraq. Drs Gerbarg and Brown are collaborating with     The Bay Pines Veterans Administration Medical Center in Florida to develop a study of this     course for treatment of American veterans returning from Afghanistan and Iraq. Elements of     this method have been used on a variety of populations. Whilst this is a multi-component     intervention, it is postulated that the most active ingredient in the program is a specific     Yoga breathing technique called Sudarshan Kriya (SK).   "
184434|NCT00256490|"     Patients affected with non-Hodgkin’s large B-cell lymphoma are treated by chemotherapy. The     evaluation of the response to this treatment is made by Positron Emission Tomography (PET/CT)     in many centres where this technology is available. Presently PET scans and CT scans are     being performed before treatment, after 4 cycles of chemotherapy and a few months after the     end of treatment.      The goal of this study is to determine if it is possible to evaluate the efficiency of     chemotherapy treatments after one cycle of treatment instead of waiting after 4 cycles, using     a new scanner that combines PET and CT modalities. Data available from studies on these     combined exams suggest that PET/CT helps to rapidly evaluate the response of the chemotherapy     treatment. We also want to verify if some pathological characteristics measured from tumor     cells will enable doctors to predict in advance the response to treatment.   "
184435|NCT00256503|"     About 10% of the population is believed to suffer from Primary Insomnia. It is also believed     that people with chronic insomnia have a sleep system that is essentially out of alignment     (we call this homeostatic dysregulation). We also know that a certain form of     non-medication therapy called cognitive-behavioral therapy is a very effective treatment for     insomnia. It is not known, however, whether cognitive-behavioral therapy actually works by     bringing the brain's sleep system back into alignment (sleep homeostasis). One of the     methods used to measure sleep homeostasis is to observe a person's brain waves during sleep     and particularly during sleep that follows a period of sleep loss.      The purposes of this study are to first learn whether persons with insomnia do have a     misaligned sleep system compared to persons who do not have insomnia by assessing the sleep     of people before and after a period of extended sleep loss. Second, the study will determine     whether cognitive-behavioral therapy can re-regulate the sleep system and its response to     sleep loss. Third, the final purpose is to examine whether the immune system of people with     insomnia is more altered following sleep loss than in the comparison group and whether     cognitive-behavioral therapy can alter immune function.   "
184436|NCT00256516|"     Exchange of the butter, eggs, cheese and meat in the Atkins diet for soy protein foods, other     vegetable proteins including gluten and vegetable fats, nuts, avocado, olive and canola oil     will result in dramatic rather than modest reductions in blood lipids with weight loss. In     effect this will represent an exchange of saturated fat and animal protein for healthy     monounsaturated and polyunsaturated fats and vegetable proteins with significant effects on     blood lipids while still encouraging weight loss.   "
184437|NCT00256529|"     This is a prospective descriptive cross sectional study to determine the percentage of     patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and     to establish which presenting factors warrant esophageal biopsies. We hypothesize that a     greater than expected percentage of patients who are biopsies will have histologic changes     consistent with EE.   "
184438|NCT00256542|"     The purpose of this study is to determine whether intravesical U101 (alkalinized     lidocaine-heparin) treatment reduces the symptoms of pelvic pain and/or urgency of bladder     origin.   "
184439|NCT00256555|"     Cystic fibrosis (CF) is a catabolic condition, and children affected with this disease     frequently have problems with growth, despite adequate nutrition. We hypothesize that the     anabolic effects of growth hormone (GH) will improve the height and weight of CF patients and     thereby improve their clinical status and their quality of life. We further hypothesize that     these effects will be sustained for at least one year after GH treatment is complete.   "
184440|NCT00256568|"     The purpose of this study is to better understand outpatient prescribing errors through     clinic and pharmacy-based error reporting systems.   "
184441|NCT00256581|"     Comparison study of myocardial perfusion SPECT imaging with current clinical use camera and     new camera.   "
184442|NCT00256594|"     The purpose of this study is to determine if a modified paper prescribing form decreases     prescribing errors compared to a traditional or standard paper prescribing form.   "
184473|NCT00257647|"     Chronic myeloid leukemia is a serious disease which is characterized by progression from     relatively quiescent stages of the disease to an aggressive phase. Although now there is     highly successful medical therapy known as Gleevec (Imatinib), the treatment is not always     successful and patients do develop resistance. Those patients have limited treatment options.     We are developing a gene therapy model of treatment for this disease using pseudoviral     particles to insert molecules of genetic material which would not allow the harmful genes     causing the leukemia to function.   "
184474|NCT00257660|"     The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport     manufactured at a new manufacturing facility in Europe.   "
184443|NCT00256607|"     A predominant consequence of diabetes mellitus (DM) type 2 is accelerated development of     atherosclerosis related conditions. Conventional cardiovascular risk factors only explain a     portion of the excess risk for atherosclerosis in this population. In vitro, animal and     epidemiologic studies have suggested that a variety of novel cardiovascular risk factors     (CVRF), including triglyceride-rich lipoproteins (TGRL), small dense low density lipoprotein     (D-LDL) subfractions, oxidative stress, and advanced glycation endproduct (AGE) formation may     contribute to the development of atherosclerosis. These risk factors may also induce     endothelial cell activation/injury or local or systemic inflammation that cause elevations in     plasma levels of additional novel risk factors, such as soluble adhesion molecules,     plasminogen activator inhibitor-1 (PAI-1), fibrinogen and C-reactive protein (CRP). Many of     these risk factors are increased in DM type 2, presumably as a consequence of hyperglycemia     and insulin resistance. However, no studies have evaluated the singular or synergistic     relationship of these novel (CVRF) to measures of atherosclerosis as well as to the     development of clinical macrovascular events in individuals with diabetes. If, as we suspect,     these novel CVRF are related to development of atherosclerosis and macrovascular disease, it     will be critical for the future design of prevention strategies to know whether intensive     glucose lowering significantly reduces the levels of these novel CVRF. Furthermore, it would     be important to explore whether the relationship of the above novel risk factors to     atherosclerosis and development of clinical events is attenuated in those individuals     receiving glucose lowering therapy. Alternatively, if glucose lowering has no effect (or a     negative effect), on relevant novel CVRF, this could potentially explain the limited success     of intensive glucose lowering to reduce macrovascular events in several prior trials.      The investigator proposes to take advantage of the study population and framework of the     recently approved VA Cooperative Study of Glycemic Control and Complications in Diabetes     Mellitus Type 2 to address these issues in an efficient and cost-effective manner.   "
184444|NCT00256620|"     The principal objective to this randomized trial is to compare the efficacy of two strategies     of intra-operative hemodynamic management during cardiopulmonary bypass among patients     undergoing primary elective coronary artery bypass graft (CABG) surgery in preventing     peri-operative cardiac, cognitive and neurologic morbidity and mortality and post-operative     deterioration in the patient's quality of life as measured by the seven domains of SF-36     Health Survey (bodily pain, health perceptions, energy, and mental, physical, social and role     function).   "
184445|NCT00257283|"     The aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid     ethyl ester 90) on the incidence of cardiovascular events and mortality in patients     undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.   "
184446|NCT00257296|"     The purpose of the study is to evaluate a multi-faceted intimate partner violence (IPV)     screening/intervention targeting abused women who are seen for prenatal care in     obstetrics-gynecology clinics or general medical care in internal medicine clinics. The     intervention is based on our clinical experience and review of the literature which suggests:     1) IPV can vary and no one pattern exists for all women; 2) recovery from abuse usually     occurs over time and not necessarily immediately after it is first detected; 3) women have     gone down many different paths leading to an abusive relationship and there is no single path     to recovery; 4) for screening/interventions to be credible and ultimately disseminated they     must respond to the complexity of the patient stories clinicians see everyday when caring for     women experiencing IPV and 5) busy obstetricians/internists/clinicians are unlikely to     effectively screen and treat women experiencing IPV unless they are supported by other     personnel trained to address IPV as well.      The intervention also is based on recommendations of IPV experts and on the theory of chronic     disease management that recognizes that the best outcomes are achieved when: 1) patients are     educated and given the support and skills to set their own goals and make their own choices;     2) multidisciplinary teams work better than programs focused only on physician behavior; 3)     active monitoring of progress is essential; 4) active coping styles using a range of     therapeutic modalities are available and 5) a stepped approach is utilized with those not     making progress or with more severe problems receiving the greatest intensity of services.      The screening/intervention will be available to each abused woman for approximately three to     six months. Patients in the evaluation study will be surveyed at the following time points:     baseline, 1 week, 1 month, 3 months, 6 months, and for the partial cohort that starts early,     9 months. Additionally, a sample of nonabused women will be surveyed at baseline to serve as     a referent group.      Our primary hypotheses are, that compared to usual care, abused women receiving the     intervention will have a reduction in levels of IPV, decreases in depression and nonspecific     physical symptoms, increase in functional health status, increase in safety behaviors,     increase in help seeking for issues related to IPV, and reduction of general medical     services.   "
184447|NCT00257309|"     General objective: To compare the efficacy and safety of primary angioplasty(PA) with that of     thrombolytic therapy (TT) for the treatment of AMI in patients >=75 years old with ST-segment     elevation or LBBB AMI <6 hours of evolution without contraindications for TT.      Hypothesis: The therapeutical strategy based on PA is superior to that based initially on TT     in patients >=75 years old with AMI.      Participating Centers: 27 Spanish hospitals performing >50 PA/year. Primary Endpoint (PE):     Incidence of the aggregate of death of any cause, reinfarction or disabling stroke at 30     days. There are also 7 secondary endpoints (SE).      Procedure: Diagnosis of inclusion/exclusion criteria --> Centralized randomization -->     Treatment allocation to 1) TT with weight adjusted TNK + unfractionated heparin or 2) PA     within 120 minutes. Estimated Sample size and recruitment time: 570 patients in 19 months.     Follow-up: Blinded evaluation of events (PROBE regulations) specified in PE and SE at 30 days     and 12 months. Quality control: 100% variable and follow-up review by external CRO. Safety     Committee and Event Adjudication Committee formed by experts not participating in the study.   "
184448|NCT00257322|"     While new treatments for metastatic and recurrent colorectal cancer have become available     over the past several years, this disease remains incurable with a limited life expectancy     from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer     are needed. Under this proposal, patients with advanced colorectal cancer will receive     Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic     cells and enhance anti-tumor immune mechanisms. This will be combined with standard     chemotherapy and patients will be followed for response and overall survival. Detailed     correlative laboratory analysis will also be performed to define the extent of dendritic cell     and cellular immune system stimulation.   "
184466|NCT00257556|"     Prospective open label, randomised, parallel group, comparative pilot.   "
184467|NCT00257569|"     To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of     pruritus of the treatment period.   "
184468|NCT00257582|"     To assess the safety of long-term use of cetirizine dry syrup in children with various type     of cutaneous disease accompanied on pruritus.   "
184469|NCT00257595|"     To assess the safety of long-term use of cetirizine dry syrup in children with perennial     allergic rhinitis.   "
184470|NCT00257608|"     This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the     safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus     bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.   "
184471|NCT00257621|"     This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in     combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI)     backbone. This study has a 48 week duration and is open to both treatment naive and     experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.   "
184449|NCT00257335|"     To demonstrate safety and efficacy of intensity-modulated radiotherapy (IMRT) for treatment     of previously irradiated recurrent head and neck cancer.      Specific Aims: Identify acute and late toxicities, response rates, locoregional control,     disease free survival, and overall survival with IMRT. Also, tumor response, the amount of     tumor shrinkage or reduction, will be analyzed.      Rationale: Recurrent head and neck cancer is regarded as having limited treatment modalities     since salvage surgery can only be accomplished on limited subgroups of patients. Chemotherapy     has not shown clear clinical benefits and has significant toxicity. Re-irradiation has been     used as a treatment modality. However, the re-irradiation dose is limited by significant     toxicity that occurs with the cumulative dose of radiation. The use of IMRT can give a high     dose to the recurrent tumor while limiting the dose to critical structures in the vicinity of     the reirradiated volume thereby limiting toxicity and treating the recurrence to an adequate     dose.      The number of subjects was determined from 2 stage design with a historical control group as     comparison, and these numbers of subjects were found to be 40.      It is assumed that this treatment regimen will not be of further interest if the true     response rate is less than 32.6% (Po0.326). It is also assumed that a true response rate of     53% or more (P10.53) would be of considerable interest in the treatment of recurrent head and     neck cancer. The type I error (the probability of rejecting the hypothesis that the     proportion responding to the treatment is less than or equal to Po when this hypothesis is     actually true) is 0.05.   "
184450|NCT00257348|"     The purpose of the study is to evaluate the effectiveness and side effects of the drugs     capecitabine and docetaxel in the treatment of cervical cancer. Capecitabine is approved by     the FDA for the treatment of breast and colon cancer. Docetaxel is approved in the treatment     of breast and lung cancer. The use of capecitabine and docetaxel in this study for the     treatment of cervical cancer is considered investigational. Eligible subjects will take the     drug capecitabine (Xeloda) by mouth twice a day every 12 hours, for fourteen consecutive days     followed by a 7 day rest period. Subjects will also receive the drug docetaxel (Taxotere)     intravenously (in the vein) every three weeks.   "
184451|NCT00257361|"     We propose to undertake an initial study of DCS to determine whether it has any short-term     clinical benefits when added to standard ERP therapy in adults with OCD.   "
184452|NCT00257374|"     Background: Pedialyte and Gatorade are advocated for the treatment of dehydration in viral     gastroenteritis, but there is limited evidence to support their use.      Objective: To examine the efficacy, safety and palatability of Pedialyte, Gatorade, and a New     Oral Rehydration Solution (NS).      Design: Randomized double blind. Setting: Inpatient, community hospital.     Patients/Interventions: 75 consecutive adult patients (m/f=44/33) admitted with viral     gastroenteritis were randomized to receive Gatorade, Pedialyte or NS for 48 hours. A     yogurt/rice diet was allowed ad libitum.      Measurements: Stool and urine output, electrolytes, fluid intake, body weight, hematocrit and     palatability of solutions.      Limitations: Smaller sample size and higher drop out (20%).   "
184453|NCT00257387|"     Evaluate the incidence of acute rejection at 12 months after transplantation in subjects     receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by     CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune     followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.   "
184454|NCT00257400|"     This study will compare the effectiveness of individual versus interpersonal psychotherapy in     treating depressed women with a history of sexual abuse.   "
184455|NCT00257413|"     Experimental data suggest that transplantation of endothelial progenitor cells (EPCs)     attenuates monocrotaline-induced pulmonary hypertension in rats and dogs. In addition,     clinical studies suggest that autogolous progenitor cells transplantation is feasible and     safe in patients with ischemic disease. This study will investigate the feasibility, safety,     and initial clinical outcome of intravenous infusion of autologous EPCs in patients with     idiopathic pulmonary arterial hypertension.   "
184456|NCT00257426|"     RATIONALE: Octreotide may stop or slow the growth of tumor cells and may be an effective     treatment for liver cancer.      PURPOSE: This phase II trial is studying how well octreotide works in treating patients with     locally advanced or metastatic liver cancer.   "
184457|NCT00257439|"     The purpose of this study is to evaluate the urinary excretion and renal metabolism of     vitamins, in particular vitamin B12 and folate, in relation to various renal conditions     involving loss of renal function and/or proteinuria.   "
184458|NCT00257452|"     To demonstrate that tiotropium (Spiriva®) does not prolong the QT interval of the ECG more     than placebo   "
184459|NCT00257465|"     The purpose of this study is to determine whether a vaccine composed of patients' own     melanoma cells treated with the chemical, dinitrophenyl (DNP)(called a hapten), is safe and     stimulates an immune response to patients' own cancer cells.   "
184460|NCT00257478|"     A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously     treated with chemotherapy.   "
184461|NCT00257491|"     To evaluate the trough and peak effect of once daily MICARDIS PLUS (Telmisartan 80     mg/hydrochlorothiazide 12.5 mg) by 24 ABPM in patients with mild to moderate essential     hypertension.   "
184462|NCT00257504|"     The purpose of the study is to test whether hypotensive episodes during dialysis - caused by     withdrawal of fluid drom the circulation - can be predicted by means of two harmless     monitoring techniques.   "
184463|NCT00257517|"     This study will assess 75-100 patients for feeding issues following surgery for single     ventricle.   "
184464|NCT00257530|"     This study will test whether addition of imiquimod to standard antimony therapy provides a     significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our     previous results, we hypothesize that lesions in patients who receive the combined treatment     of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and     produce less scarring than treatment with pentavalent antimony alone.   "
184655|NCT00253643|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of fish oil and/or green tea may prevent prostate cancer.      PURPOSE: This randomized clinical trial is studying how well a fish oil and/or green tea     supplement works in preventing prostate cancer in patients with prostatic intraepithelial     neoplasia or who are at risk for developing prostate cancer.   "
184477|NCT00257699|"     Crohn's disease (CD) is a form of inflammatory bowel disease that can affect any part of the     digestive system. Symptoms of this chronic illness include abdominal pain, bloating, nausea,     vomiting, and diarrhea. CD also causes bowel wall ulcers, strictures (narrowings of a hollow     structure due to scar tissue and swelling), and fistulae (abnormal passages from the     intestines to another organ or to the skin).      CD is thought to arise from a combination of inherited (genetic) factors and some undefined     environmental factor(s). One environmental factor that has been shown to be intimately     involved with the development of CD is the presence of bacteria that normally inhabit the     intestines. As a result, some physicians have tried to alter the normal bacterial population     as a means of controlling the inflammation (swelling) in the intestines of individuals with     CD. Among such strategies is the use of a combination of metronidazole and ciprofloxacin.     These broad-spectrum antibiotics control CD symptoms by acting on the intestinal bacteria     that can contribute to chronic inflammation. More investigation is needed to firmly establish     the usefulness of this therapy because previous clinical trials have given mixed results,     although they have suggested that antibiotics can be particularly useful in cases of Crohn's     colitis (CD that primarily affects the large intestine). Because these earlier studies have     lacked a large enough patient population with colonic involvement, a trial focusing on this     CD subgroup with a sufficient number of subjects will help to clarify the value of combining     metronidazole and ciprofloxacin.      The proposed study will test the hypothesis that combination antibiotic therapy is effective     in the treatment of CD involving the colon. The study will compare the use of combination     therapy consisting of metronidazole and ciprofloxacin with placebo (dummy tablets) and will     examine the results of treatment at the end of 8 weeks of treatment.   "
184478|NCT00257712|"     The purpose of the SMART study was to better understand whether the body's own production of     growth hormone (GH) would improve memory and problem solving ability, or cognitive function.     The study was a double blind, placebo-controlled study of the cognitive effects of growth     hormone releasing hormone (GHRH) in healthy older men and women and in those with mild     cognitive impairment (MCI).   "
184479|NCT00257725|"     This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in     4-to-5-year olds.   "
184480|NCT00257738|"     Squamous Cell Carcinoma of the Head and Neck (SCCHN) is a devastating illness, the treatment     of which is associated with significant morbidity. This type of cancer affects 43,000     individuals each year with an estimated survival rate of 50%. A potential treatment     alternative for this patient population is the use of peptide-based immunotherapy. This     clinical tial will be using a vaccines comprised on the Trojan peptides MAGE-A3 and HPV 16 to     treat patients with Squamous Cell Carcinoma of the Head and Neck who have recurrent,     progressive or metastatic SCCHN.   "
184481|NCT00257751|"     Clopidogrel (Plavix), a platelet ADP receptor antagonist, has become the standard of care to     prevent thrombosis in interventional cardiology and is increasingly being used in unstable     angina and NSTEMI. An increasing number of patients are referred to emergent or urgent CABG,     and several studies, as well as our own experience, have shown that preoperative     administration of irreversible platelets inhibitors increase the risk of bleeding     complications following CABG.   "
184482|NCT00257764|"     Swallowing dysfunction after stroke is common, but there is no reliable evidence for how it     should be managed other than perhaps by nasogastric tube. This study compared the     effectiveness of standardised, low and high intensity behavioral intervention for dysphagia     with that of “usual care”.   "
184483|NCT00257777|"     Controversies still exists concerning the overall clinical effects of blood-based vs.     crystalloid- based cardioplegic solution for myocardial protection during cardiac arrest.     Both techniques are used world-wide. No larger prospectively randomized studies comparing the     two methods have been reported. The aim of this study is to collect a large number of     clinical data to create a proper basis for evaluation of the two techniques.   "
184484|NCT00257790|"     Evaluate if tobramycin given once a day is at least as efficacious as the traditional     tobramycin given three times a day, given with penicillin G, til patients with febrile     neutropenia.   "
184485|NCT00257803|"     Oxytocin is normally given either rapidly into the vein (bolus) or put into an intravenous     bag and administered more slowly, after delivery of the baby by cesarean section. Both of     these methods are commonly used. To date there has been little research to demonstrate that     one method of giving oxytocin is better than another in women who are more likely to bleed     after delivery. The purpose of the study is to see whether a small bolus of oxytocin makes     the uterus contract better to reduce bleeding and decreases the need to give additional     oxytocin or more powerful drugs in women who are at risk for bleeding after delivery of their     baby by cesarean section.   "
184516|NCT00258206|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving rituximab together with     cyclophosphamide may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with     cyclophosphamide works in treating patients with high risk, refractory, or relapsed multiple     myeloma.   "
184486|NCT00257816|"     There will be approximately 14,000 new patients with invasive cervical cancer diagnosed in     the United States in 2003 with about 4,000 deaths from this disease. This accounts for     approximately 17% of all deaths due to gynecologic cancers. Radiation has been the primary     treatment modality for locoregionally advanced cervical cancer. Recent trials of concomitant     systemic cisplatin chemotherapy and radiation have shown high response rates (RR) with     improvements in durable remissions and overall survival. Though the incidence and mortality     in the U.S. dropped steadily from years 1940 to 2000, there has recently been a plateau,     arresting the decline. With the routine addition of systemic Cisplatin (CDDP) chemotherapy to     local regional radiation, mortality from advanced cervical cancer in the United States is     expected to further decrease. However, further advances in this disease are needed.   "
184487|NCT00257829|"     The Phenomenon of Tumor Hypoxia Many solid tumors are relatively resistant to treatment with     ionizing radiation and certain chemotherapeutic agents such as anthracyclines that are     affected adversely by acidic pH. These effects have primarily been attributed to the presence     of hypoxic cells within the tumor. The relevance of hypoxia with respect to failure of     radiotherapy to cure certain malignancies has had a chequered history. However, in recent     years the evidence that hypoxia plays a central role in relative radioresistance has become     more compelling.      Since approximately two-thirds of all women suffering from cervical carcinoma receive     radiation as a component of their therapy, an enhanced understanding of the interactions     between hypoxia and radiation as a component of their therapy, an enhanced understanding of     the interactions between hypoxia and radiation resistance is critical to improving outcome     among those with cervical cancer.   "
184488|NCT00257842|"     Constipation is a common disorder and current treatments are unsatisfactory. Biofeedback may     help patients with constipation and dyssynergic defecation, but its efficacy is unproven and     whether this is due to behavioral modification or excessive attention is unknown. Methods: In     a prospective randomized trial, the investigators investigated the efficacy of Biofeedback     (manometric- assisted anal relaxation, muscle coordination and simulated defecation     training), with either sham feedback therapy (Sham) or standard therapy (diet, exercise,     laxatives; Standard) in 77 subjects (69 women) with dyssynergic defecation. Primary outcome     measures included presence of dyssynergia, balloon expulsion time, number of complete     spontaneous bowel movements (CSBM), and global bowel satisfaction. Data analyzed per     protocol.   "
184489|NCT00257855|"     A present there is no safe treatment for reducing rate at which disability worsens in people     with secondary progressive multiple sclerosis. Recent research has suggested the possibility     that drugs that act by blocking the entry of sodium into nerve cells can protect nerve fibres     in the brain and spinal cord. In this trial, the investigators will test whether one such     drug, called lamotrigine, can prevent damage to nerve fibres and reduce the rate at which MS     worsens. The period of treatment in the trial will run for 2 years.   "
184490|NCT00257868|"     The purpose of this study is to determine whether Rivastigmine is effective for the     prevention of postoperative delirium in patients undergoing cardiac surgery.   "
184491|NCT00257881|"     The primary purpose of this study is to evaluate the safety, tolerability, and maximum     tolerated dose (MTD) of CMD-193 administered intravenously (IV) to subjects with advanced     malignant tumors. The secondary purpose is to obtain preliminary information on the     pharmacokinetics and antitumor activity of IV CMD-193.   "
184492|NCT00257894|"     The purpose of this study is to determine whether baclofen is effective in reducing smoking     urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers.   "
184493|NCT00257907|"     This study will examine how the immune system responds to infection with Mycobacterium     tuberculosis bacteria (bacteria that cause tuberculosis) in order to better understand how     the germ produces infection and how the immune response might work to control the infection.      Only about one in 10 people infected by M. tuberculosis become sick, sometimes years or even     decades after exposure. It is not known why some people become sick and most do not, but the     immune system of people who never develop disease may be better able to control the bacteria.     This study will evaluate the latent form of M. tuberculosis infection to further the     understanding of the immune mechanisms - particularly the role of certain white blood cells -     involved in the disease process.      Healthy volunteers 18 years of age and older may be eligible for this study. Candidates are     screened with a medical history, family history of medical conditions, sexual history,     history of drug use, physical examination and blood tests, including a test for HIV. People     in Mali, West Africa, and in local health clinics in the United States may participate.      At the start of the study, participants have blood tests and a tuberculin skin test (PPD     test), which indicates whether a person has been exposed to tuberculosis bacteria. For the     PPD, a tiny amount of liquid containing dead tuberculosis antigen is put under the skin of     the forearm with a needle. The antigen cannot cause infection or disease.      After 3 days, participants have another blood test and the site of the tuberculin test is     examined for swelling that would indicate a positive result. Participants with a positive PPD     have a chest x-ray to check for tuberculosis disease. Those whose x-ray is also positive are     withdrawn from the study and referred to their doctor for evaluation and treatment. Those     whose x-ray is negative return to the clinic within 3 weeks of the tuberculin test to give     another blood sample.      Participants whose PPD is negative have a second tuberculin test 10 to 21 days later and     return 3 days after the test to determine if it is still negative or if it is positive. (Some     people who are negative after the first test may test positive after the second procedure.)     Those whose test is still negative end their participation in the study at that time.     Participants whose second PPD is positive have a chest x-ray as described above, and those     with a negative chest x-ray return in 3 weeks to donate one last blood sample.      The purpose of the present study is to evaluate the latent form of this infection, the     prevalence of which worldwide exceeds that of active disease. Our hypothesis is that in     latent tuberculosis antigen specific effector memory CD4+ T cells are responsible for the     generation of clinically measurable delayed type hypersensitivity and that central memory     CD4+T cells are not directly involved in this process. We base this idea on the assumption     that latent tuberculosis is a state of antigen persistence and that effector memory T cells     should be maintained as long as antigen/infection is present.      We propose to conduct this study in Mali, West Africa and local clinics in the U.S.     Tuberculosis affects 593/100,000(2) individuals in Mali and most have been exposed to the     disease. Additionally it would be important to evaluate the same parameters locally as latent     infection is one of the major factors for reactivation tuberculosis in this country. Patients     would be enrolled in 4 major groups: HIV-/TST- (Group A), HIV-/TST+ (Group B), HIV+/TST+(G     roup C) and HIV+/TST- (Group D).      To evaluate this hypothesis we plan to enroll between 100 - 300 patients over the course of 2     years from both countries. Blood samples before and at predetermined time points after the     application of Purified Protein Derivative (PPD) will be obtained to determine the fraction     of CD4+ T cells which produce interferon gamma in response to stimulation with PPD with a     16hr antigen stimulation assay. Appropriate staining will be done to ascertain the phenotype     as well as cytokine production (Interferon gamma,( IFN gamma), Interleukin 2 (IL2) and Tumour     Necrosis Factor ( TNF)). Additionally lymphocyte proliferation will be studied using     5-(and-6)-carboxyflouorescein diacetate succinimidyl ester (CFSE.)      In conducting this study we hope to further the understanding of the immune mechanisms     involved, particularly mechanisms of T cell memory, which would provide insights into TB and     HIV pathogenesis. We also believe that understanding these mechanisms could lead towards     establishment of surrogates for immunity in TB vaccine studies, which could enhance vaccine     trial design. It might also help in understanding better the immunological dynamics of     tuberculosis co-infection in individuals with HIV infection.   "
184494|NCT00257920|"     The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol®     Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on     hemodialysis.   "
184495|NCT00257933|"     This study hopes to determine the appropriate oral steroid dose for treating children     hospitalized with asthma exacerbations. Practice guidelines from different countries     recommend a wide range of doses, and the doses used in actual practice vary widely. There is     no data on what is the most appropriate dose of prednisone (or equivalent) in this situation.     We will be looking at the dose recommended by the National Asthma Education and Prevention     Program guidelines, which are published by the National Heart, Lung, and Blood Institute, as     compared with a lower dose which is commonly used in practice. We hypothesize that the lower     dose will be no worse than the higher dose as determined primarily by duration of     hospitalization.   "
184496|NCT00257946|"     The objective of this study is to evaluate the use of 2 different types of biosynthetic     material for the repair of congenital diaphragmatic hernia. The research question is: what is     the best material for repairing large congenital diaphragmatic hernias? The primary outcome     variable is recurrence.   "
184497|NCT00257959|"     This is an open parallel design randomized trial of amiodarone plus a beta blocker vs a beta     blocker alone vs sotalol for the prevention of ICD shocks in patients receiving an ICD for     spontaneous or inducible ventricular tachycardia or fibrillation   "
184498|NCT00257972|"     The purpose of this research study is to compare the efficacy of aripiprazole with placebo in     combination with lithium or valproate monotherapy, in the treatment of bipolar I patients     with manic or mixed episodes.   "
184499|NCT00257985|"     The aim of the present study is to explore functional consequences of migraine gene mutations     on their responses to GTN infusion.   "
184500|NCT00257998|"     Recently a clinical prediction rule (CPR) has been developed and validated that accurately     identifies patients with low back pain that are likely to benefit from a lumbo-pelvic     manipulation. The studies that developed and validated the rule used the identical     manipulation procedure. However, recent evidence suggests that different manual therapy     techniques may result in the same outcome.Purpose: The purpose of this study is to     investigate the effectiveness of three different manual therapy techniques in a subgroup of     patient with low back pain that satisfy the CPR.   "
184542|NCT00258570|"     The purposes of this study are:        -  to determine if there are specific genetic traits that might explain why patients have          developed pulmonary fibrosis;        -  to determine if specific genetic traits account for differing patterns of inflammation          and scar tissue that has formed in the patient's lungs.   "
184501|NCT00258011|"     This is a multi-center, open label, study conducted to evaluate the safety of laronidase     administered by intravenous drip infusion in Japanese patients with MPS I disease.      Following baseline evaluation, patients will receive weekly infusions of JC0498 at an     intravenous dose of 100 units/kg. Patient safety will be monitored continuously throughout     the trial. In addition, the effects of JC0498 treatment in this patient population will be     assessed by periodically evaluating aspects of MPS I disease in patients at scheduled     intervals over the duration of the trial.      Since patients may be eligible for the trial if they have received JC0498, a portion of the     data may be captured retrospectively and recorded onto the case report forms (CRFs).      This study represents the first good clinical practice (GCP) effort to characterize MPS I in     the Japanese population and evaluate the effects of JC0498 on disease manifestations.   "
184518|NCT00258245|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Ascorbic acid may help arsenic trioxide work better by making cancer     cells more sensitive to the drug. Bortezomib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells     by stopping blood flow to the cancer. Giving arsenic trioxide and ascorbic acid together with     bortezomib, thalidomide, and dexamethasone may stop the growth of and kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide     when given together with ascorbic acid, bortezomib, thalidomide, and dexamethasone in     treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia.   "
186200|NCT00284310|"     The purpose of this trial is to follow-up on patients who underwent different types of wrist     surgery: 4-row arthrodesis or proximal row carpectomy.   "
184502|NCT00258024|"     Malaria is one of the major causes of illness and mortality in Sub-Saharan Africa. In Ghana,     malaria is the most important cause of morbidity and accounts for about 40% of outpatient     contacts. Chemoprophylaxis and insecticide-impregnated bed nets are used for malaria control     in pregnancy.Chloroquine is administered within the ANC package at health facilities in     Ghana. However, many pregnant women in rural,low-income communities do not report for ANC or     report late thereby increasing their risk of morbidity and mortality. Reasons for this     include inaccessibility and high cost. As the gap between urban and rural health care and     socioeconomic circumstances increase, malaria control remains the major challenge of the     health sector. A facility-based intervention alone is not sufficient to have a significant or     sustained impact on malaria control in pregnancy. Alternative strategies are needed for the     delivery of malaria interventions to pregnant women in rural areas in Ghana. The overall     objective of this study is to develop alternative strategies for community involvement for     delivery of malaria interventions to pregnant women in rural Ghana. The project will be     conducted in the Afigya Sekyere district in the Ashanti Region of Ghana. Interviews and focus     group discussions will be conducted with pregnant women and community members focusing on     local knowledge on control of malaria in pregnancy and factors influencing utilization of     antenatal services. Women in their first and second pregnancies who are permanently resident     in the study area will be included in the study using IPT with sulphadoxine-pyrimethamine     (SP). The study population will be randomized to:Group 1 will receive clinic-supervised     IPT-SP and daily folate/iron supplementation and Group 2 will access IPT-SP with daily     folate/iron supplementation from trained traditional birth attendants (TBA). Midwives and     TBAs will be trained in preparing thick blood smears and placenta biopsies for     parasitological examination. Parasitaemia and Hb will be measured at entry and at delivery     and fever episodes during pregnancy will be recorded. Study participants will be followed for     adverse reactions within a week after drug administration. The effectiveness of     community-based IPT for the control of malaria in pregnancy will be determined. The endpoints     of the study will be birth weight, maternal anaemia, fever episodes and prevalence of     peripheral and placental parasitaemia in the groups.   "
184503|NCT00258037|"     Aim: To evaluate the long term effect of pelvic floor muscle training in women with urinary     incontinence after ischemic stroke measured by quality of life paramters.   "
184504|NCT00258050|"     To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics     of a single oral and single intravenous dose of midazolam in adult cancer patients. Also to     assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.   "
184505|NCT00258063|"     The objective of this study is to estimate exposure to the hormones norelgestromin,     norgestrel, and ethinyl estradiol in healthy female volunteers across multiple commercial     lots of EVRAÂ® (a transdermal contraceptive patch manufactured by LOHMANN Therapie-Systeme),     to compare these data to exposure data from one clinical lot, and to compare these data to     exposure data from a commercially available oral contraceptive.   "
184506|NCT00258076|"     The objective of this study is to estimate the exposure to the hormones norelgestromin,     norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers across     multiple commercial lots of ORTHO EVRAÂ® (a transdermal contraceptive patch) and to compare     these data to historical hormonal exposure data from one ORTHO EVRAÂ® clinical development     lot.   "
184507|NCT00258089|"     The purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an     antibiotic) with that of oral ciprofloxacin in the treatment of complicated urinary tract     infections in adults.   "
184508|NCT00258102|"     The purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an     antibiotic) with that of oral lomefloxacin in the treatment of complicated urinary tract     infections in adults.   "
184509|NCT00258115|"     Chronic subaccute inflammation may underlie the development of diabetes cardiovascular     disease and other components of the metabolic syndrome. Rodent studies suggest diet induced     obesity is associated with activation of the IKK/NF-kB pathway and this pathway can be     inhibited by salicylates. This study seeks to determine the effect of salicylates in     overweight persons.   "
184510|NCT00258128|"     We believe that diet induced obesity leads to activation of the IKK/NF-kB inflamatory pathway     and that chronic inflammation leads to insulin resistance and diabetes. In rodents,     salicylates inhibit IKK/NF-kB and may improve insulin sensitivity. We will study if this is     true in people.   "
184511|NCT00258141|"     The study will find out how effective rupatadine is in the treatment of mosquito bite     symptoms in adult patients allergic to mosquito bites.   "
184512|NCT00258154|"     The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due     to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the     safety and immunogenicity of either vaccine.   "
184513|NCT00258167|"     -  Research demonstrates that the families of the seriously mentally ill are burdened by          this caregiving role and by their responsibilities        -  Research also demonstrates that family interventions are effective and that they have a          potential to reduce family burden, as well as to improve the condition of the mentally          ill patients.        -  We assume that the sibling group intervention would be effective in reducing the family          burden of the siblings, and that this reduction would be reflected in their replies to          the Experience of Caregiving Inventory.   "
184514|NCT00258180|"     RATIONALE: Cyclophosphamide may help control the symptoms of autoimmune enteropathy .      PURPOSE: This phase II trial is studying how well cyclophosphamide works in treating young     patients with severe autoimmune enteropathy.   "
184515|NCT00258193|"     -  The primary objective of this trial is to compare the dose-ranging pharmacodynamic          effects of orally administered placebo, and 100 and 1000 ug qd of MD-1100 Acetate on          gastrointestinal transit in patients with C-IBS.        -  The secondary objectives of this trial are:             1. To compare the dose ranging pharmacodynamic effects of placebo, and 100 and 1000 ug               MD-1100 Acetate once daily on time to first bowel movement after first drug intake.             2. To describe and summarize the effects of placebo, and 100 and 1000 ug MD-1100               Acetate once daily on stool frequency, stool consistency, ease of passage and               sensation of incomplete evacuation during the Treatment Period relative to               Baseline.   "
184517|NCT00258232|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as capecitabine and irinotecan, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving celecoxib together with capecitabine and irinotecan may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving celecoxib together with capecitabine     and irinotecan works in treating patients with recurrent or metastatic colorectal cancer.   "
184548|NCT00258661|"     Osteopathic Manipulative Treatment (OMT) were used in the 1800s and 1900s to treat pneumonia     before the introduction of antibiotics in the mid-1900s. The purpose of this study is to     determine if OMT, when used in conjunction with antibiotics and other usual care, will     improve the recovery of elderly pneumonia patients.   "
184519|NCT00258258|"     RATIONALE: Paricalcitol may cause multiple myeloma cells to look more like normal cells, and     to grow and spread more slowly. Paricalcitol may also stop the growth of the cancer cells by     blocking blood flow to the cancer. Zoledronate may delay or prevent bone metastases in     patients with multiple myeloma. Giving paricalcitol together with zoledronate may be an     effective treatment for multiple myeloma or other plasma cell disorders.      PURPOSE: This clinical trial is studying the side effects and best dose of paricalcitol when     given with zoledronate in treating patients with relapsed or refractory multiple myeloma or     other plasma cell disorders.   "
184520|NCT00258271|"     RATIONALE: Drugs used in chemotherapy, such as cladribine and cytarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Giving cladribine and cytarabine together with imatinib     mesylate may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate     when given together with cladribine and cytarabine in treating patients with refractory or     relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia.   "
184521|NCT00258284|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel     works in treating patients with metastatic prostate cancer.   "
184522|NCT00258297|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can     be removed.      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with     stage I, stage II, or stage III esophageal cancer that can be removed by surgery.   "
184523|NCT00258310|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any     remaining tumor cells.      PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who     have undergone previous surgery, radiation therapy, and/or chemotherapy for head and neck     cancer.   "
184524|NCT00258323|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving more     than one drug (combination chemotherapy) may kill more tumor cells. Cisplatin and     fluorouracil may also make tumor cells more sensitive to radiation therapy. Gefitinib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     radiation therapy together with combination therapy and gefitinib before surgery may make the     tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these     treatments after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving radiation therapy together with     combination chemotherapy and gefitinib before and after surgery works in treating patients     with advanced esophageal or gastroesophageal junction cancer.   "
184525|NCT00258336|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others     interfere with the ability of cancer cells to grow and spread. Vaccines made from a person's     cancer cells may help the body build an effective immune response to kill cancer cells.     Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in     bone marrow or peripheral blood. Giving rituximab together with vaccine therapy and GM-CSF     may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with vaccine     therapy and GM-CSF works in treating patients with indolent B-cell non-Hodgkin's lymphoma.   "
184526|NCT00258349|"     This phase I/II trial is studying the side effects and best dose of vorinostat when given     together with trastuzumab and to see how well they work in treating patients with metastatic     breast canceror breast cancer that has recurred in the chest wall. Vorinostat may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as trastuzumab, can block tumor growth in different ways. Some find tumor     cells and kill them or carry tumor-killing substances to them. Others interfere with the     ability of tumor cells to grow and spread. Vorinostat and trastuzumab also may stop the     growth of tumor cells by blocking blood flow to the tumor. Giving vorinostat together with     trastuzumab may be a better way to block tumor growth.   "
184543|NCT00258583|"     The purpose of this study is to place past, current, and future medical record information     into the UPMC Simmons Center for Interstitial Lung Disease Research Registry.   "
184527|NCT00258362|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination     chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed     by radiation therapy works in treating patients with stage III, stage IV, or recurrent     endometrial cancer.   "
184528|NCT00258375|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-011     may help docetaxel kill more tumor cells by making tumor cells more sensitive to the drug.      PURPOSE: This phase II trial is studying how well giving OGX-011 together with docetaxel     works in treating women with locally advanced or metastatic breast cancer.   "
184529|NCT00258388|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. OGX-011 may help docetaxel and prednisone kill more tumor cells by making tumor     cells less resistant to the drugs.      PURPOSE: This randomized phase II trial is studying how well giving docetaxel and prednisone     with or without OGX-011 works in treating patients with recurrent or metastatic prostate     cancer that did not respond to previous hormone therapy.   "
184530|NCT00258401|"     RATIONALE: Eating a diet low in residue (fiber, fat, and certain milk or vegetable products)     may help prevent or reduce diarrhea caused by pelvic radiation therapy.      PURPOSE: This randomized clinical trial is studying a low-residue diet to see how well it     works compared to no dietary intervention in treating diarrhea in patients who are undergoing     radiation therapy to the pelvis for uterine, cervical, or prostate cancer.   "
184531|NCT00258427|"     RATIONALE: A bone marrow or umbilical cord blood transplant may be able to replace     blood-forming cells that were destroyed by chemotherapy. Giving combination chemotherapy     before a donor stem cell transplant may make the transplant more likely to work. This may be     an effective treatment for patients with high risk Fanconi's anemia.      PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating     high risk patients who are undergoing a donor stem cell transplant for Fanconi's anemia.   "
184532|NCT00258440|"     RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat     anemia caused by cancer and chemotherapy. It may also help relieve fatigue in patients with     anemia.      PURPOSE: This randomized clinical trial is studying how well epoetin alfa works in treating     patients with anemia who are undergoing chemotherapy for cancer.   "
184533|NCT00258453|"     RATIONALE: Collecting information on how craniopharyngioma is diagnosed and treated may help     doctors predict a patient's response to treatment and help plan the best treatment. It may     also help identify the intermediate- and long-term effects of treatment.      PURPOSE: This clinical trial is collecting information on diagnosis, treatment, and quality     of life of young patients who are undergoing surgery for craniopharyngioma.   "
184534|NCT00258466|"     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill     tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not     yet known which type of radiation therapy is more effective in treating prostate cancer.      PURPOSE: This randomized phase III trial is studying different types of radiation therapy to     compare how well they work in treating patients with stage I, stage II, or stage III prostate     cancer.   "
184535|NCT00258479|"     Nicotine is one of the most widely abused substances in the United States. Nicotine     replacement therapy (NRT) is currently an effective treatment for nicotine dependence;     however, even with NRT most people fail at quitting smoking after their first attempt.     Modafinil is a promising drug that may be useful in treating nicotine dependent individuals.     The purpose of this study is to evaluate the safety of the combination of modafinil and NRT     in treating nicotine dependent adolescent smokers.   "
184536|NCT00258492|"     A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep     quality among patients with Restless Legs Syndrome (RLS). We, the researchers at Northeastern     Ohio Universities College of Medicine, hypothesize that, relative to a control group, RLS     sufferers who participate in an aerobic exercise intervention will demonstrate:        1. reduced RLS symptoms;        2. improved sleep quality;        3. reduced daytime sleepiness.   "
184537|NCT00258505|"     The outcome of brain injury (physical or stroke) may be related to a brain electrical     phenomenon known as Cortical Spreading Depression (CSD). This is a brief cessation of     function in a local region of brain tissue. It has been hypothesized that CSD may occur after     brain injury and may expand the damage to adjacent brain areas. Our aim is to detect CSD by     means of intracranial electrodes in patients with brain injuries and asses how these events     alter the outcome of the patients.   "
184538|NCT00258518|"     The investigators aim to compare the respiratory mechanics in acute lung injury (ALI)/acute     respiratory diseases syndrome (ARDS) patients with and without pleural effusion.   "
184539|NCT00258531|"     -  A commercial 3-dimentional magnetic imaging system (Olympus ScopeGuide) is available for          routine use during colonoscopy.        -  No randomised trials have been performed to evaluate if, and to what extent, the use of          this technology may improve the coecal intubation rate and reduce the patient's          experience of discomfort and pain by making the insertion of the endoscope easier   "
184540|NCT00258544|"     This study is investigating the way the lung is damaged in a condition called pulmonary     fibrosis. Research studies will be conducted on lung tissue obtained from an open lung biopsy     performed by the subject's surgeon. The identification of unique genetic markers of scarred     lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary     fibrosis.   "
184541|NCT00258557|"     The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r     versus Kaletra (a combination pill of lopinavir and ritonavir, (lpv/rtv) in HIV-1 infected     patients who have never been treated with anti-retroviral medications (referred to as     treatment-naïve patients).   "
184930|NCT00265291|"     Our goal is to study pharmacogenetics in Mexican-Americans, using depression treatments as a     proof of the concept that pharmacogenetic approaches can be used to optimize treatment     strategies for common and complex disorders in this population.   "
184544|NCT00258596|"     Primary intracoronary stent placement after successfully crossing chronic total occlusions     (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional     balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in     selected groups of patients. Whether sirolimus-eluting stents are superior to bare metal     stents in CTO is unknown. In this prospective randomized trial, bare metal stent implantation     will be compared with sirolimus-eluting stent implantation for the treatment of chronic total     coronary occlusions. A total of 200 patients will be followed up for 6, 12, and 24 months     with angiographic follow-up at 6 months. Quantitative coronary analysis will be performed by     an independent core laboratory. The primary end point is the binary angiographic restenosis     and reocclusion rate at 6 month follow-up.   "
184545|NCT00258609|"     The purpose of this study is to determine whether 120 Unit, and 240 unit of botulinum toxin A     are effective in the treatment of migraine without aura prophylaxis.   "
184546|NCT00258622|"     Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine     and placebo in patients with peripheral chronic neuropathic pain.   "
184547|NCT00258635|"     The purpose of this study is to assess the immunological differences between three     RagweedMATAMPL treatment arms compared to placebo with respect to immunoglobulin levels.      In addition, the study will assess the reduced allergenicity of modified Ragweed Pollen     contained in RagweedMATAMPL compared to unmodified native allergen using skin prick testing.   "
184550|NCT00258687|"     The purpose of this study is to learn if a vaccine made from the patient's own tumor cells,     then genetically modified to secrete granulocyte-macrophage colony-stimulating factor     (GM-CSF), will delay or stop the growth of the tumor. It will also look at the vaccine's     effects on the immune system and the side effects of giving a vaccine made from a subject's     own cancer cells.   "
184551|NCT00258700|"     The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC     conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal     serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month     schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15     months of age.   "
184552|NCT00258713|"     The purpose of this study is to determine the safety and efficacy of voclosporin in patients     with plaque psoriasis.   "
184553|NCT00258726|"     This study will test the safety and how well the body's immune system responds to a live, but     weakened varicella (chickenpox) vaccine, known as Varivax, given with and without ProQuad,     another measles, mumps, rubella, and varicella virus vaccine (MMR-II). One hundred five     healthy children will be enrolled in the study when they are 12 months old. All subjects will     be vaccinated at 12 months of age and some subjects will receive a second vaccination at 18     months of age. All subjects will participate for 1 year. This study is a single-site,     two-year trial with post-licensure vaccines.   "
184554|NCT00258739|"     Primary objective:        -  To classify the 2 study groups, according to the tumoral response.      Secondary objectives:        -  To evaluate the percentage of focused control per year.        -  To calculate the time until progression.        -  To evaluate the safety profile.   "
184555|NCT00258752|"     This study will compare Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST),     IPT-AST plus parent involvement (Enhanced IPT-AST), and Usual Care for the prevention of     adolescent depression.   "
184556|NCT00258765|"     Radical prostatectomy is used to treat early prostate cancer in otherwise well men, but is     followed by later cancer relapse in 1 in 4 cases. This study aims to see if post-operative     adjuvant therapy with a combination of zoledronic acid and docetaxel might help reduce     relapse in such cases. Patients will be randomized to receive the adjuvant combination     therapy or no therapy. All patients will be monitored closely for signs of relapse and     treated appropriately with conventional salvage therapy.   "
184557|NCT00258778|"     Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the     human glucocerebrosidase gene (GCD)leading to reduced activity of the lysosomal enzyme     glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer)in     the cells of the monocyte-macrophage system.      This is the first trial to utilize a recombinant active form of lysosomal enzyme,     glucocerebrosidase, (human prGCD)which is expressed and purified in a bioreactor system from     transformed carrot plant root cell line.   "
184558|NCT00258791|"     The purpose of the study is to determine whether ibuprofen reduces post-ECT headache or     reduces its severity.   "
184559|NCT00258804|"     Primary Objectives :        -  To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic,          nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and          glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan.      Secondary Objectives :        -  To assess glycaemic control before, during and after Ramadan in terms of HbA1c, FBG, and          8-point blood glucose profile (FBG and 8-point blood glucose profile will be collected          with a blood glucose monitor through a monthly patient diary).        -  To assess the relationship between hypoglycaemia events during Ramadan and blood glucose          control prior and during Ramadan.        -  To assess patient satisfaction        -  To document adverse events (all serious adverse events, non serious adverse events)          throughout the study (all events will be collected through the monthly patient diary).   "
184600|NCT00259337|"     The present clinical study will assess the immunogenicity as the primary objective and the     reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined     vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of     age followed by a booster dose during the second year of life.      Safety:      This study will describe the safety after each dose of the primary series of the study's     combined vaccine (Pentaxim™).   "
184560|NCT00258817|"     To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for     Disease Control and Prevention (CDC), and the World Health Organization (WHO) for     characterization of circulating influenza strains.      Observational Objectives:      To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in     the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to <     36 months.      To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine,     administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥     6 months to < 36 months.   "
184561|NCT00258830|"     To describe the safety during Days 0 to 21 following injection of the 2005-2006 formulation     of the inactivated, split-virion influenza vaccine Fluzone in subjects aged 18-59 years and     subjects aged ≥ 60 years.      To describe the immune response (antibodies to hemagglutinin) 21 days following injection of     the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in     subjects aged 18-59 years and subjects aged ≥ 60 years.      To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER)     for further analysis by the Food and Drug Administration (FDA), Center for Disease Control     and Prevention (CDC) and the World Health Organization (WHO) to support selection and     recommendation of antigen strains for subsequent influenza vaccines.   "
184562|NCT00258843|"     To describe the tolerance in terms of occurrence of serious adverse reactions and severe     adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX     Polio™ administered in children and infants.   "
184563|NCT00258856|"     The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged     7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study     603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of     participants who will receive a booster dose of Menactra® vaccine and children in the same     age group not previously vaccinated with a meningococcal vaccine or had meningitis disease     who will receive a dose of Menactra® vaccine.   "
184564|NCT00258869|"     We propose to develop novel diagnostic tests for severe sepsis and community acquired     pneumonia (CAP). This program, entitled Community Acquired Pneumonia & Sepsis Outcome     Diagnostics (CAPSOD), is a multidisciplinary collaboration involving investigators at six     organizations: NCGR; Duke University Medical Center, Durham, NC; Henry Ford Hospital,     Detroit, MI; Eli Lilly and Company, Indianapolis, IN; Indiana Centers for Applied Protein     Sciences, Indianapolis, IN; and ProSanos Corp., La Jolla, CA.      In the United States, Community Acquired Pneumonia is the sixth leading cause of death and     the number one cause of death from infectious diseases. Of the 5.6 million annual cases of     CAP, 1.1 million require hospitalization for intensive therapy. Sepsis, commonly known as     blood poisoning or bloodstream infection, is the tenth leading cause of death in the US and     the number one cause of death in non-cardiac intensive care units. Incidence of sepsis is     increasing by 9% each year and mortality rates vary between 25 and 50%. Cost to the US     healthcare system exceeds $20 billion each year.      In patients with suspected sepsis or early CAP, rapid identification of patients who will     develop severe sepsis or CAP is critical for effective management and positive outcome. The     CAPSOD study is designed to identify novel tests for early diagnosis of severe sepsis and     CAP. When performed in patients at the earliest stages of disease, these tests will have     prognostic value, rapidly identifying those who will have poor outcomes or complicated     courses.      CAPSOD will prospectively enroll patients with sepsis and CAP at Duke University Medical     Center and Henry Ford Hospital. The study will use advanced bioinformatic, metabolomic,     proteomic and mRNA sequencing technologies to identify specific protein changes, or     biomarkers, in patient blood samples that predict outcome in sepsis and CAP. Development of     biomarker-based tests will permit patient selection for appropriate disposition, such as the     intensive care unit, and use of intensive medical therapies, thereby reducing mortality and     increasing effectiveness of resource allocation.   "
184565|NCT00258882|"     To further characterize the vaccine safety profile and to identify any signals of potentially     vaccine-related adverse events (AEs) not detected during pre-licensure studies.   "
184566|NCT00258895|"     Primary Objectives:        1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of          age who have previously received 4 doses of DAPTACEL® or Pentacel™.        2. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in          DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of          DAPTACEL® or Pentacel™.      Observational Objectives:        1. To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses          to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously          received 4 doses of DAPTACEL® or Pentacel™.        2. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.        3. To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among          subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a          2nd dose of MMR.   "
184567|NCT00258908|"     To assess the immunogenicity profile of ADACEL™, Tetanus and Diphtheria Toxoids Adsorbed     combined with Component Pertussis Vaccine (TdcP Vaccine) one month after administration.      To describe the safety profile of ADACEL™ (TdcP Vaccine) when given as a fifth dose.   "
184568|NCT00258921|"     To support physicians in their active management of hypertensive patients. By targeting     specific systolic and diastolic blood pressure (BP) figures physicians will closely monitor     the BP values and as such will have an individualized control of the treatment in each     patient.   "
184569|NCT00258934|"     All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will     test whether an influenza vaccine is effective when injected by a route other than into the     muscle. In order to prove this, the amount of antibodies in the blood will be measured before     and after vaccination. In addition, the safety of both influenza vaccines will be tested by     evaluating all serious reactions occurring after vaccination. The vaccine injected in this     study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In     addition, the safety of both influenza vaccines administered by different routes will be     tested by evaluating all adverse events and especially all serious reactions.      Primary Objective: To demonstrate and compare the immune response of an influenza vaccine     after a single dose when administered by different routes.      Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with     the European Medicine Agency (EMEA) after the first injection.   "
184570|NCT00258947|"     Primary Objective:      To estimate the smallpox vaccination take rate in healthy young adults not previously     vaccinated with a smallpox vaccine.      Secondary Objectives:      To describe antibody response to vaccination and evaluate the take for each subject at     various timepoints for each batch and pooled batches and to evaluate local signs, symptoms,     and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.   "
184643|NCT00253474|"     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon     alfa-2b in treating young patients with plexiform neurofibroma.   "
184571|NCT00258960|"     Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that     will be administered every 4 weeks.      Sample size calculation will be done by means of Simon's method in 2 stages for phase II     studies and will be based on the principal aim of the study (evaluation of the rate of     objective response).      The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate     of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment     when the rate of response targets be lower than 35 %. In this case, considering an alpha     error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study     would continue if more than 5 objective responses were found. The total number of patients to     including in the study would be 44. The results will be significant if they find at least 20     objective responses.      Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.   "
184572|NCT00258973|"     The purposes of this study are to determine:        1. Inter-site variability in CIMT image measurement using SonoCalcTM.        2. If non-sonographer health care professionals working in an office practice setting can          be trained to follow a carotid scanning protocol that permits (a) accurate measurement          of CIMT and (b) determination of plaque presence.        3. If (a) CIMT measurements and (b) determination of plaque presence by non-sonographer          health care professionals are bioequivalent to those made by a core laboratory.        4. If CIMT measurements and plaque assessment performed in office practices lead to          meaningful changes in patient and physician behavior related to cardiovascular disease          prevention.   "
184573|NCT00258986|"     The purpose of this study is to compare the effects of hand-assisted laparoscopic and     mini-incision muscle-splitting donornephrectomy on living kidney donors. The hypothesis is     that the mini-incision is not inferior to the laparoscopic technique.   "
186201|NCT00284323|"     Investigate the effect of selective intracoronary administration of adenosine on myocardial     salvage and microvascular integrity in the setting of acute myocardial infarction.   "
184574|NCT00258999|"     The study will evaluate the clinical utilization of skin Cholesterol (SC) for cardiovascular     risk assessment in asymptomatic individuals at low, intermediate and high risk based on     Framingham global risk estimates.      Preliminary studies have suggested that SC is an easy to measure, noninvasive marker of     cardiovascular risk. This study is intended to provide further data in support of broader     clearance by the Food and Drug Administration for the use of SC as a tool to identify     asymptomatic patients at increased risk of cardiovascular disease. Currently, SC testing is     cleared for use as part of risk assessment in subject suspected of having significant     multi-vessel disease.      The current study data will be used to support the use of SC testing as part of     cardiovascular risk assessment in subjects without suspected coronary artery disease (CAD).   "
184575|NCT00259012|"     The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic     (PD) profiles to determine the safety and tolerability of single and multiple doses of     pantoprazole in infants aged 1 through 11 months.   "
184576|NCT00259025|"     The main purpose of this study is to investigate whether intravenous infusion of a lipid     emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate     variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis     patients.   "
184577|NCT00259038|"     The study will evaluate the safety and efficacy of intravenous infusion of carperitide using     pressure measurements inside the heart and great vessels and measuring carperitide     concentration in the blood.   "
184578|NCT00259051|"     The purpose of this study is to investigate the pharmacodynamic effect of omeprazole n a     Japanese non-erosive reflux disease population   "
184579|NCT00259064|"     The purpose of the study is to determine if the addition of Iressa to Best Supportive Care     treatment will increase the progression free survival of chemo-naïve, poor performance status     patients, with stage IIIB or IV NSCLC.   "
184580|NCT00259077|"     The purpose of this study is to study safety and efficacy of omeprazole standard treatment in     a Japanese non-erosive reflux disease population.   "
184581|NCT00259090|"     To compare the anti-tumour effects as measured by changes in various biomarkers, of a     combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal     women patients with primary breast cancer who are awaiting curative-intent surgery.   "
184582|NCT00259103|"     The purpose of this study is to assess the safety and efficacy of rhRlx for cervical     ripening, when compared to a placebo.   "
184583|NCT00259116|"     This trial is a single center, open-label, dose-finding study of recombinant human relaxin     (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.   "
184584|NCT00259129|"     This is an open-label, non-randomized Phase I study of sorafenib 400 mg bid (2 x 200 mg     tablets) in cancer patients. The primary objective of the study is to evaluate the effect of     sorafenib on cardiovascular safety parameters. The secondary objectives are to evaluate the     safety, pharmacokinetics, and anti-tumor activity of sorafenib in cancer patients   "
184585|NCT00259142|"     Malaria remains a major cause of morbidity and mortality particularly among children < 5     years in Uganda. Due to inaccessibility many children die before they reach the health     facility. The Home Based Management of Fever (HBMF) strategy was adopted in Uganda as a mean     to improve access to early and appropriate treatment of fever at community level. Pre-packed     chloroquine with sulphadoxine-pyrimethamine (HOMAPAK) is provided through Community Drug     Distributors(CDDs). Initial evaluation showed underutilization of the CDDs (15%). This cast     doubt on community acceptability, accessibility as well as its feasibility and cost     effectiveness. This 3-year project intends to compare community acceptability and cost     effectiveness of two HOMAPAK distribution methods. The current CDD-based HOMAPAK distribution     versus home-based HOMAPAK distribution. The study hypothesis is that home-based HOMAPAK     distribution is more acceptable to the community and more cost effective than the CDD based     HOMAPAK A non randomised community study will be conducted in two sub-counties of Mukono     district. In the control arm, HOMAPAKs will be distributed through the CDDs while in the     intervention arm, HOMAPAKs will be directly distributed to the caretakers in the homes. The     study population are caretakers and their children < 5 years. At baseline a survey (Phase 1)     with a sample size 657 in each study area will assess the common drugs stocked at home to     treat malaria and the health seeking behaviour for malaria for children < 5 years and to     determine the prevalence of malaria parasitaemia and anaemia among children < 5 years. Phase     2 includes the intervention. The villages will be assigned to either the control or     intervention arm. Anaemia and malaria parasitaemia among children with fever will be assessed     through active case finding. The impact of either distribution system on accessibility,     acceptability, sustainability, compliance, cost effectiveness and malaria morbidity will be     assessed during the evaluation phase. Health education messages on malaria prevention and     treatment will be given to both communities. Drug misuse will be limited by distributing     HOMAPAKs according to the number of children <5years in each household. HOMAPAK will only be     replenished after the caretaker returns a used packet to the CDD.   "
184654|NCT00253630|"     This phase II trial is studying how well vorinostat works in treating patients with relapsed     or refractory indolent non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as     vorinostat, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth.   "
184586|NCT00259155|"     We have recently shown that the majority of patients with irritable bowel syndrome (IBS) have     an abnormal lactulose breath test to suggest the presence of bacterial overgrowth of the     small intestine. In open label and double blind treatment of IBS subjects with antibiotics, a     dramatic improvement in clinical symptoms are observed. In these studies, the antibiotic     chosen was neomycin, which is noted to have an efficacy of 20-25% in normalizing the     lactulose breath test. A more efficacious antibiotic is needed. Therefore the aim of this     study is to determine the efficacy of rifaximin in normalizing the lactulose breath test in     IBS subjects with concomitant improvement in clinical symptoms.   "
184587|NCT00259168|"     The purpose of this study is to determine whether attenuation/normalization of elevated blood     sugar after meals ameliorates vessel wall (endothelial) function in individuals with insulin     resistance.   "
184588|NCT00259181|"     Chlorhexidine gluconate (CHX), as an anti plaque agent, is commonly used with a variety of     products. In this study we, the investigators at Hadassah Medical Organization, intend to     examine the efficacy of a single dip in CHX of provisional restoration prior to oral     cementation. If the protocol is effective, we intend to calibrate it and recommend clinical     use of the protocol. The examination of biofilm formation will be both with electron     microscope and confocal scanning laser microscope.   "
184604|NCT00259389|"     Adherence to a doctor-prescribed anti-HIV drug regimen is crucial in the management of HIV     infection. In previous studies with tuberculosis patients, directly observed therapy (DOT), a     strategy in which patients are observed while taking their medications, has been proven     useful in increasing patient adherence. The purpose of this study is to determine the     effectiveness of a new DOT strategy in HIV infected adolescents who have had difficulty     adhering to anti-HIV drug regimens or regimens to prevent opportunistic infections (OIs) in     the past.   "
184589|NCT00259194|"     Coronary angiography via the femoral artery is regarded as a safe procedure, but bleeding     complications are often seen. To avoid/reduce bleeding complications digital compression is     applied in the area of puncture during approximately 20 minutes and the patient is in the     investigators' department observed in bed for 2 hours. The investigators apply pressure over     the puncture site using a sand bag in the first hour. The patients are told not to move, to     keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours     (standard observation). In the present study the patients are randomized between standard     observation and an alternative observation, where the patients are allowed to lift their     head, arms and legs during the 2 hours, otherwise as standard observation.      The study has three aims:        1. To establish the incidence of bleeding complications:             -  Frequency of hematoma (> 5 cm)             -  Frequency of pseudoaneurysms             -  Frequency of bleeding demanding surgery             -  Frequency of bleeding demanding transfusion        2. Establish a model to predict in wich patient to expect a bleeding complication.        3. Assess if the alternative observation is associated with more bleeding complications          compared to standard observation.   "
184590|NCT00259207|"     The purpose of this study is to compare 2 techniques of pulmonary valve replacement in     patients with a large right ventricular outflow tract: a standard surgical treatment using     cardiopulmonary bypass versus a medico-surgical hybrid strategy without extracorporeal     circulation.   "
184591|NCT00259220|"     Gastric lavage is usually used for gastric preparation before endoscopy in patients with     upper gastrointestinal bleeding. However, the benefit-risk balance of putting a nasogastric     tube in these patients is not clearly defined. This randomized trial is aimed to determine if     the use of erythromycin IV before endoscopy could avoid to put a gastric tube for the     management of upper gastrointestinal bleeding.   "
184592|NCT00259233|"     12 obese subjects will receive peripheral administration of placebo and 4 escalating doses of     PYY1-36 and another 12 obese subjects will receive peripheral administration of placebo and 4     escalating doses PYY3-36 on 5 different test days within one week. The patients will be     tested in a single blinded dose escalating protocol. Measurements of appetite, ad libitum     energy intake, blood pressure and blood sampling will be performed during the test day.   "
184593|NCT00259246|"     The aim of the study is to compare fasting and postprandial PYY levels between     overweight/obese and lean subjects during and after an infusion of saline, PYY1-36 or PYY3-36     and to evaluate the efects on appetite, energy intake and energy expenditure.   "
184594|NCT00259259|"     To evaluate the short-term effects of structured lipids on appetite regulation.   "
184595|NCT00259272|"     A non randomized study to validate the MATHYS Scale in a population of in and outpatients     greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and     treated with olanzapine.   "
184596|NCT00259285|"     To determine the response to this regimen for therapy prior surgery in patients with locally     advanced disease or metastatic disease.   "
184597|NCT00259298|"     The purpose of this study is to evaluate the effects of teriparatide on skeleton images in     postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that     stimulates the production of new bone in the skeleton. This process of bone formation can be     studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This     trial will test whether bone scans will identify areas of the skeleton that are forming new     bone during teriparatide therapy. It also will study what these areas look like after therapy     is stopped.   "
184598|NCT00259311|"     The purpose of this study is to determine whether a compound known as LY2422347 is effective     in treating people diagnosed with primary insomnia (difficulty sleeping with no other     significant contributing factor, such as depression).   "
184599|NCT00259324|"     The US is in the midst of an obesity epidemic, affecting young children. The pediatric     primary care setting is an ideal place to address this problem since most families have     frequent contact with their pediatrician and a child's health status is regularly assessed in     this setting. Recommendations for treating children with a body mass index (BMI) over the     85th percentile in the primary care setting have been developed by an Expert Committee on     childhood. Programs are needed that meet the recommendations from the Committee, which     include: 1) beginning treatment as young as possible; 2) focusing on the family, with the     parent being the primary change agent for treatment; 3) using behavior modification     techniques to change eating and activity behaviors; and 4) making 2 or 3 very specific     changes in diet and activity at one time. Thus, the aim of this R21 application is to     develop, implement, and evaluate a 6-month behavioral childhood obesity intervention that     meets the Committee's recommendations and can be implemented in a primary care setting. A     second aim of this project is to determine which eating and activity behaviors should be     targeted in the intervention. One hundred thirty-five children, aged 4 to 9 years with a BMI     > 85th percentile, assessed and referred by their pediatricians, will be randomized to one of     three conditions: 1) a newsletter condition; 2) a Behavioral Parenting Program that increases     physical activity (60 min/day) and decreases sweetened drink consumption (< 3 servings/week)     (Traditional); or 3) a Behavioral Parenting Program that reduces TV watching (< 2 hours/day)     and increases low-fat milk consumption (2 servings/day) (Substitutes). Follow-up assessments     on weight, height, and standardized BMI (z-BMI), the primary dependent variable, will be     conducted at 3, 6, 9, and 12 months. Pediatricians will provide follow-up letters to     families, regarding weight and height status, following the assessments. This pilot study     allows us to determine the feasibility and efficacy of a pediatric obesity intervention that     optimizes the role of the pediatrician and meets the Committee's recommendations for     treatment in a primary care setting. Moreover, by comparing the effects of targeting the     traditional or substitute behaviors, data will be obtained for a power analysis for a     full-scale trial of the effects of these two approaches on long-term weight loss.   "
184601|NCT00259350|"     The best antiseptic solution for cateheter care remains unknown.High concentration in aquous     solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone     iodine in aquous solutions. No study has compare alcoholic formulations of low concentration     of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central     venous catheters.      To compare the incidence of central venous catheter colonization after skin disinfection with     either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine,     0.025% Benzalkonium and 4% benzylic alcohol.      To compare the incidence of catheter related bacteremia in the to study groups. To compare     the local and general tolerance of the two antiseptic formulations   "
184602|NCT00259363|"     -  Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed          doses of oxaliplatin in this study        -  Phase II: To determine the treatment efficacy according to response rates from phase I.   "
184603|NCT00259376|"     To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus     rhythm after electrical, pharmacological or spontaneous conversion of atrial     fibrillation/atrial flutter (AF/AFL).      To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of     AF/AFL recurrence.      To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.   "
184606|NCT00259415|"     This study is a collaborative effort between a community-based service organization,     Supportive Older Women's Network (SOWN), and an academic research division at Thomas     Jefferson University (TJU). We plan to use a randomized controlled two-group design to: 1)     test the effectiveness of the intervention at 6 months to enhance social support and     perceived efficacy in comparison to a control group; 2) test if gains are sustained over 12     months (within experimental group comparison); and 3) evaluate the cost and cost     effectiveness of the intervention. Three secondary study aims are to describe the process and     content of tele-support groups (dose/intensity, support group topics); evaluate the relative     benefits for African American and White females; and determine if control group subjects     benefit from receiving a peer's telephone number for mutual support (within group comparison     between 6 and 12 months).   "
184607|NCT00259428|"     To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus     rhythm after electrical, pharmacological or spontaneous conversion of atrial     fibrillation/atrial flutter (AF/AFL).      To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.      To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of     AF/AFL recurrence.   "
184608|NCT00259441|"     The contrast induced kidney toxicity has been known to affect the mortality and morbidity in     the patients undergoing coronary angiography. But the mechanism and therapeutic strategy for     it is not well known. Nowadays, it is reported that the N-acetylcysteine may have preventive     effects for contrast induced kidney toxicity with its antioxidant effects.The statins have     been reported to have many other effects other than the lipid lowering effect-including     antioxidant effect, so we hypothesized that the antioxidant effect of simvastatin may prevent     the contrast induced kidney toxicity.   "
184609|NCT00259454|"     This study tests the effectiveness of an in-home intervention to reduce upset and burden     among family caregivers, and decrease nursing home placement. The main hypothesis that will     be tested is that compared to control group, subjects, experimental group participants will     have enhanced well-being and fewer nursing home placements.   "
184610|NCT00259467|"     Specific Aims        1. Establish a preliminary effect size for the impact of the intervention on depressive          affect and agitated behaviors in persons with dementia in 4 months        2. Evaluate acceptance of and engagement in activities in persons with dementia        3. Establish a preliminary effect size for the impact of the intervention on caregiver          burden, depressive symptoms, and mastery at 4 months.        4. Evaluate caregiver skills acquisition, acceptance of and compliance to intervention          techniques.   "
184611|NCT00259480|"     The specific aims of this study are to:        1. Test the immediate effectiveness of the intervention to reduce caregiver upset with          targeted disruptive behaviors (primary outcome). Hypothesis: Caregivers in the          intervention group will report less upset with target behaviors at 4-months in          comparison to caregivers in the control group.        2. Test the immediate effectiveness of the intervention to reduce caregiver burden          (secondary outcome). Hypothesis: Caregivers in the intervention group will report less          burden at 4-months in comparison to caregivers in the control group.        3. Test the immediate effectiveness of the intervention to reduce the frequency of          occurrence of targeted disruptive behaviors in persons with dementia (secondary          outcome). Hypothesis: Caregivers in the intervention group will report a decrease in the          frequency of occurrence of targeted behaviors at 4-months in comparison to caregivers in          the control group.        4. Test the maintenance effect of intervention at 6-months on caregiver upset and burden          and targeted disruptive behaviors. Hypothesis: Compared to usual care, caregivers in          intervention will maintain reduced upset and burden and report less occurrences of          targeted behaviors from 4 to 6-months.        5. Assess the cost of the intervention and its cost effectiveness.      We have also received funding to conduct a supplementary study to evaluate the effect of the     nurse intervention on behavior reduction and caregiver distress. The specific aims of this     supplementary study arm are to: 1) describe the prevalence and type of medical conditions     among control group participants who receive the nurse intervention, 2) describe for those     with a detected medical condition/problem, the number of caregivers who follow-up with     physicians and the type of physician follow-up/treatment that occurs; 3) evaluate whether     control group participants who receive the nurse intervention report reduced disruptive     behaviors and caregiver upset at 6 weeks (pre-post comparison); and 4) for control group     participants who receive the nurse intervention, compare the level of disruptive behaviors     and caregiver upset 4 months from entry into this study arm with the results in the Project     ACT experimental group (who received the multi-component intervention).   "
184612|NCT00259493|"     The purpose of this study is to compare graft patency rates following coronary artery bypass     graft surgery performed by beating heart vs. conventional techniques using cardiac CT     scanning to evaluate the bypass grafts.   "
184613|NCT00259506|"     Research project regarding the possibility to implement and the efficacy of a non-drug,     psychotherapeutic intervention (MBCT), in preventing relapse/recurrence of depression.   "
184614|NCT00259519|"     Two-year multicentre randomized controlled parallel trial to compare intentional delivery and     conservative management in pregnant women with preterm and prelabour rupture of membranes     between 32 and 35 weeks.      The purpose of this study is to determine whether intentional delivery of women with PPROM     between 32 and 35 week's gestation can decrease the overall neonatal morbidity associated     with PPROM-related complications without increasing the morbidity associated with a shortened     pregnancy.   "
184615|NCT00259532|"     The purpose of this project is to evaluate and compare three new methods for diagnosis,     staging, operability evaluation and treatment control of pancreas cancer. The investigators     use contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and     Cholecystokinin, which triggers the enzyme production of pancreas. The hormones induce an     increased metabolism and thus an increased blood flow through healthy pancreas tissue,     however, not in tumor tissue. The investigators hope to be able to use this effect     diagnostically. The patients included will also have a 64-slice-CT in order to evaluate, if     an increased diagnostic safety can be reached compared to an older CT scanning method. All     patients will also be examined for the tumor marker CA 19-9. Further, the investigators will     examine if contrast-enhanced ultrasound can contribute with information in treatment control     after either surgery or medical treatment.   "
184616|NCT00259545|"     The purpose of this study is to evaluate if retarded release phosphatidylcholine is an     effective alternative to steroid dependent or -refractory course in chronic active ulcerative     colitis.      The hypothesis is, that ulcerative colitis is caused by a barrier defect of the colonic mucus     layer. The background of the study is the finding, that the phosophatidylcholine content of     the colonic mucus is strongly reduced in ulcerative colitis (UC) compared to healthy controls     and patients with Crohn´s disease. The content was measured in non-inflamed areas of the     colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method     for steroid dependent UC. See: Gut. 2005 Jul;54(7):966-71. Stremmel et al.   "
184617|NCT00259558|"     The purpose of this study is to find the optimal dose of retarded release Phosphatidylcholine     in the most severe form of ulcerative colitis.      The hypothesis is that ulcerative colitis (UC) is caused by a barrier dysfunction of the     colonic mucus layer. The background of the study is the finding, that the phosphatidylcholine     (PC) content of the colonic mucus is strongly reduced in UC compared to healthy controls and     patients with Crohn´s disease. The content was meuasured in non-inflamed areas of the colon     in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method.   "
184618|NCT00259571|"     The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as     mesalazin in preventing an acute episode in ulcerative colitis.      The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of     the colonic mucus. The background of the study is the finding that the phosphatidylcholine     content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy     and inflamed parts of the colon.   "
184619|NCT00259584|"     All patients with symptomatic malignant SVCO deemed suitable for treatment either with     radiation therapy or by stenting will be eligible. They will receive whichever treatment is     deemed most clinically appropriate. Symptomatic response, time to onset of palliation,     duration of symptom control and survival will be assessed.   "
184620|NCT00259597|"     Breast nipple aspirate fluids (NAF) are useful for non-invasive monitoring of the breast. NAF     has been shown to exhibit large inter-individual differences in lipid peroxidation.     Unfortunately, the yield of epithelial cells in NAF is low. More recently, breast ductal     lavage has been approved for clinical use. Nuclear morphologic features of breast biopsies     have been shown previously to have prognostic value for breast cancer risk. In women without     cancer, there may be subtle changes in the breast epithelial cells that can only be defined     with computer-assisted measurements. The subjects selected for this study will be 98 women     with biopsy-confirmed proliferative breast disease. These women are at slightly increased     breast cancer risk, and exhibit higher mean levels of cholesterol and cholesterol oxides in     NAF than women with non-proliferative histology in the breast. Levels of 8-isoprostane,     cholesterol, fatty acids, fat-soluble micronutrients and 2,6-cyclolycopene-4,5-diol will be     quantified in breast NAF that is obtained before breast lavage. These measures were chosen     based on their potential relationship to dietary intakes and to oxidative stress, which is     relevant to the application of these methods to dietary prevention studies.The investigators     will characterize the morphology of breast epithelial cells from lavage using quantitative     image cytometry to capture nuclear and cellular area, diameter, roundness, perimeter, and     nuclear:cytoplasmic area ratio. Correlations will be evaluated between the measured     morphologic features and each analyte in the NAF. The impact of various clinical, demographic     and dietary factors on cellular morphology will also be explored. This study will help     establish the feasibility of using these measures as endpoints in dietary intervention     studies and will generate hypotheses that should be tested in larger studies. Such measures     also should be applicable to molecular epidemiological investigations that seek to examine     the impact of certain gene polymorphisms and environmental exposures on biomarkers of cancer     risk.   "
184621|NCT00259610|"     The purpose of this study is to 1)to determine if it is better to treat all early RA patients     with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination     with etanercept or reserve this treatment for patients who do not appropriately respond to     methotrexate alone and 2) to determine which combination of methotrexate therapy is better   "
184622|NCT00259623|"     The objective of the study is to evaluate the efficacy of the epicardial or endocardial     radiofrequency ablation in the treatment of atrial fibrillation.      It is a multicentric, prospective, randomized, parallel, comparative, double blind study. The     study principal objective is to evaluate the absence of atrial fibrillation after 3 months.     The secondary objectives consist in the evaluation of the maintenance of the sinusal heart     rate at one year and of the quality of life improvement   "
184623|NCT00259636|"     Patients with fibromyalgia & migraine are randomized to receive zonisamide or placebo.   "
184624|NCT00259649|"     Women are followed prospectively for 3 months, recording headaches, other symptoms, and     menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan     for 3 months.   "
184625|NCT00259662|"     This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG     coA reductase inhibitor class of drugs referred to as statins, will reduce inflammatory     responses and deep vein thrombosis formation when given in high doses in the perioperative     period.   "
184626|NCT00259675|"     To see the efficacy of using chemotherapies alternatively (carboplatin and gemcitabine     alternating with carboplatin and taxol) for pts with stage IIIB (nonresectable and stage IV     NSCLC.   "
184627|NCT00259688|"     Hypothesis: The prevalence of sleep apnea is greater in pregnant women with preeclampsia than     in pregnant women without preeclampsia.The presence of sleep apnea will be associated with     poor blood pressure control, worsening blood pressure during sleep and evidence of fetal     distress. The usual treatment for sleep apnea is to have the patient breathe pressurized air     through a mask. This is called continuous positive airway pressure (CPAP). In preeclamptic     women with sleep apnea, use of CPAP will result in improved blood pressure control and     reduced fetal distress.   "
184628|NCT00259701|"     This study attempts to test capillary responses to various challenges without the need for     iontophoresis (electrical current).   "
184629|NCT00259714|"     Salt and water excess is an essential mechanism of hypertension. This is particularly     relevant to patients with end stage kidney disease (ESKD) on dialysis. We have demonstrated     that individualization of the sodium concentration in the dialysate as to match the patient's     own serum sodium concentration leads to less thirst, interdialytic weight gain, and better BP     control in hypertensive patients. In this study we will evaluate the mechanisms underlying     this response by measuring systemic hemodynamics, body volume spaces, and biochemical marker     of volume status.   "
184630|NCT00259727|"     The purpose of this study is to determine the mechanisms by which HIV protease inhibitors     contribute to the development of diabetes in HIV-infected patients. The investigators propose     that some HIV protease inhibitors impair insulin secretion and increase the production of     glucose by the liver.   "
184631|NCT00259740|"     The purpose of this study is to determine if denosumab is effective in the treatment of     relapsed or plateau-phase multiple myeloma.   "
184632|NCT00259753|"     The objective of this study is to evaluate the safety and preliminary efficacy of three doses     of Cand5. Cand5, a small interfering RNA molecule that selectively silences the mRNA encoding     for VEGF.   "
184633|NCT00259766|"     The purpose of this study is to compare health-related costs and asthma control in ordinary     clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as     needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and     Symbicort fixed dosing plus Bricanyl as needed in asthmatic patients not adequately     controlled on inhaled glucocorticosteroids alone.   "
184634|NCT00259779|"     To assess if Symbicort forte Turbuhaler (during two weeks) is as effective as an oral course     of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute     exacerbation of Chronic Obstructive Pulmonary Disease (COPD).   "
184972|NCT00267280|"     The Torcetrapib project was terminated on December 2, 2006 due to safety findings.      Cholesterol levels will be measured over six weeks in subjects being treated with two     different kinds of cholesterol medications to see how the different treatments compare to one     another.   "
184635|NCT00253370|"     This phase II trial is studying how well giving sorafenib together with docetaxel and     cisplatin works in treating patients with metastatic or locally advanced gastric or     gastroesophageal junction cancer that cannot be removed by surgery. Sorafenib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking     blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving sorafenib together with docetaxel and cisplatin may kill more     tumor cells.   "
184636|NCT00253383|"     RATIONALE: Palliative care may help patients with advanced cancer live more comfortably.      PURPOSE: This randomized clinical trial is studying an early intervention palliative care     program to see how well it works compared to a standard care program in improving end-of-life     care in patients with advanced lung , gastrointestinal, genitourinary, or breast cancer.   "
184637|NCT00253396|"     The purpose of this study is to determine which short-acting blood thinner     (low-molecular-weight heparin [Enoxaparin] or unfractionated heparin) is associated with less     discomfort and bruising when given as a subcutaneous (under the skin) injection before and     after a planned surgery or procedure in patients who temporarily stop warfarin.   "
184638|NCT00253409|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving combination chemotherapy before surgery may shrink the     tumor so that it can be removed. Giving radiation therapy after surgery may kill any tumor     cells that remain after surgery. It is not yet known whether combination chemotherapy is more     effective with or without surgery and radiation therapy in treating mesothelioma.      PURPOSE: This randomized clinical trial is studying combination chemotherapy, surgery, and     radiation therapy to see how well they work compared to combination chemotherapy alone in     treating patients with mesothelioma that can be removed by surgery.   "
184639|NCT00253422|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of     estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not     yet known whether giving fulvestrant together with anastrozole is more effective than giving     fulvestrant together with a placebo or exemestane alone in treating breast cancer.      PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how     well they work compared to fulvestrant and a placebo or exemestane alone in treating     postmenopausal women with locally advanced or metastatic breast cancer.   "
184640|NCT00253435|"     RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry     radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such     as carboplatin, etoposide, and melphalan, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. An autologous peripheral stem cell or bone marrow     transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and     radiation therapy. Giving iodine I 131 metaiodobenzylguanidine and combination chemotherapy     with an autologous peripheral stem cell or bone marrow transplant may allow more chemotherapy     to be given so that more tumor cells are killed. Giving radiation therapy after an autologous     peripheral stem cell or bone marrow transplant may kill any remaining tumor cells.      PURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine     together with combination chemotherapy and radiation therapy works in treating patients who     are undergoing an autologous peripheral stem cell or bone marrow transplant for relapsed or     refractory neuroblastoma.   "
184641|NCT00253448|"     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and     cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor     cells. Giving stereotactic radiosurgery together with radiation therapy may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving stereotactic radiosurgery together     with radiation therapy works in treating patients with glioblastoma multiforme.   "
184642|NCT00253461|"     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET scan) using 11C     topotecan, may help doctors predict a patient's response to treatment and help plan the best     treatment.      PURPOSE: This phase I/II trial is studying how well a PET scan using 11C topotecan predicts     response to treatment in patients with brain metastases due to ovarian, small cell lung, or     other cancer.   "
184644|NCT00253487|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, busulfan, and O6-benzylguanine,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. O6-benzylguanine may also help temozolomide work better by making tumor     cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor     cells. Giving chemotherapy with a peripheral stem cell transplant or bone marrow transplant,     using stem cells from the patient that are genetically-modified in the laboratory to protect     them from the side effects of chemotherapy, may allow more chemotherapy to be given so that     more tumor cells are killed. Giving combination chemotherapy and radiation therapy together     with a peripheral stem cell transplant or bone marrow transplant may kill more tumor cells.      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together     with radiation therapy works in treating younger patients who are undergoing an autologous     stem cell transplant for newly diagnosed gliomas.   "
184645|NCT00253500|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     epirubicin before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed.      PURPOSE: This phase II trial is studying how well epirubicin works in treating women who are     undergoing surgery for stage I, stage II, or stage III breast cancer.   "
184914|NCT00257114|"     Multiple myeloma represents the second most common hematological malignancy.VELCADE is a     small molecule to treat human malignancies. Its anti-neoplastic effect invovles several     distinct mechanisms including inhibition of cell growth. Patients who have relapsed or are     refractory to therapy, the standard of care is now VELCADE based on the results of previous     clinical trials.   "
184646|NCT00253513|"     RATIONALE: Drugs used in chemotherapy, such as treosulfan and fludarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving treosulfan and fludarabine together with a donor bone marrow transplant or a     peripheral stem cell transplant may be an effective treatment for acute myeloid leukemia,     acute lymphoblastic leukemia, or myelodysplastic syndrome.      PURPOSE: This phase II trial is studying giving treosulfan together with fludarabine to see     how well it works in treating patients who are undergoing a donor stem cell transplant for     acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome.   "
184647|NCT00253526|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells an     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine     hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells.      PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how     well they work compared to gemcitabine hydrochloride alone in treating patients who are     undergoing surgery for pancreatic cancer.   "
184648|NCT00253539|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. Estrogen can cause the growth of breast cancer cells. Hormone therapy using     arzoxifene or tamoxifen may prevent breast cancer by lowering the amount of estrogen the body     makes. The use of arzoxifene or tamoxifen may keep breast cancer from forming in women at     high risk for breast cancer.      PURPOSE: This randomized phase II trial is studying arzoxifene to see how well it works     compared to tamoxifen or a placebo in preventing breast cancer in premenopausal women at high     risk for breast cancer.   "
184649|NCT00253552|"     RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor bone marrow     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as     G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can     be collected and stored.      PURPOSE: This clinical trial is studying how well a G-CSF-treated donor bone marrow     transplant works in treating patients with hematologic cancer or noncancer.   "
184650|NCT00253565|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving imatinib mesylate     together with capecitabine may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate     when given together with capecitabine in treating patients with advanced solid tumors.   "
184651|NCT00253578|"     This phase II trial is studying how well sorafenib works in treating patients with relapsed     or refractory multiple myeloma. Sorafenib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth and by blocking blood flow to the cancer   "
184652|NCT00253591|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as vinorelbine and cisplatin, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet     known whether giving radiation therapy together with vinorelbine and cisplatin is more     effective than radiation therapy alone in treating non-small cell lung cancer.      PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy     together with vinorelbine and cisplatin works and compares it to radiation therapy alone in     treating patients with stage I, stage II, or stage III non-small cell lung cancer.   "
184653|NCT00253617|"     RATIONALE: Stent placement may help reduce symptoms caused by the tumor. Photodynamic therapy     uses a drug, such as porfimer sodium, that becomes active when it is exposed to a certain     kind of light. When the drug is active, tumor cells are killed. This may be an effective     treatment for cholangiocarcinoma. It is not yet known whether stent placement and     photodynamic therapy using porfimer sodium are more effective than stent placement alone in     treating cholangiocarcinoma.      PURPOSE: This randomized phase III trial is studying stent placement and photodynamic therapy     using porfimer sodium to see how well they work compared to stent placement alone as     palliative treatment in treating patients with stage III or stage IV cholangiocarcinoma that     cannot be removed by surgery.   "
184656|NCT00253669|"     RATIONALE: Patients with gliomas may be at risk for developing blood clots. Learning about     the risk factors for developing blood clots may help doctors plan better treatment for     gliomas.      PURPOSE: This clinical trial is studying risk factors for developing blood clots in patients     who are undergoing cancer treatment for newly diagnosed gliomas.   "
184657|NCT00253682|"     This study will determine the impact of highly active antiretroviral therapy (HAART) on the     developing cardiovascular system, the evolution of HAART-associated cardiovascular changes     over time, and the association between cardiovascular measurements with HAART exposure.   "
184658|NCT00253695|"     This study is a first step in approaching the gap existing between understanding sleep     abnormalities, alterations in sleep-regulating cytokines and HIV-1 disease regulating     cytokines, and abnormal higher cortical function.   "
184659|NCT00253708|"     RATIONALE: Massage therapy may help relieve symptoms associated with cancer. It is not yet     known which type of massage therapy is more effective in treating the symptoms of patients     with cancer.      PURPOSE: This randomized clinical trial is studying different types of massage therapy to     compare how well they work in treating the symptoms of patients with locally advanced or     metastatic cancer.   "
184915|NCT00257127|"     The purpose of this study is to determine immune system function following vaccination in     HIV-infected children currently taking anti-HIV drugs. To test the effectiveness of prior     vaccination, patients in this study will receive booster shots of one of two pneumococcal     vaccines, a hepatitis B vaccine, and a measles vaccine.   "
184660|NCT00253721|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     drugs directly into the arteries around the tumor may kill more tumor cells. Mannitol may     open the blood vessels around the brain [Blood-Brain Barrier Disruption (BBBD)]and allow     melphalan to be carried directly to the brain tumor. Giving melphalan together with BBBD may     be an effective treatment for central nervous system cancer.      PURPOSE: This phase I trial is studying side effects and best dose of melphalan when given     together with mannitol in treating patients with central nervous system cancer.   "
184661|NCT00253734|"     The purpose of this research study is to find out if giving the smaller dose of flu vaccine     under the skin generates antibodies against flu compared to giving the vaccine the usual way,     as a shot in the arm. If using smaller doses in this manner is effective, the current supply     of vaccine could be used to make more doses to give to more people. About 217 healthy adults,     18 to 49 years of age, will participate. The study will be conducted at one site in the     United States and subjects are expected to participate for about 6 months. Blood samples will     be taken to assess the immune system response. Local and systemic safety will be evaluated in     the 28 days following vaccination.   "
184662|NCT00259792|"     The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with     conventional stepwise treatment according to asthma treatment guidelines in patients with     persistent asthma.   "
184663|NCT00259805|"     The purpose of this study is to assess the safety, tolerability and effectiveness of     rituximab in the treatment of chronic focal encephalitis.   "
184664|NCT00259818|"     This is a Phase I, dose escalation study of EM-1421 administered by intravenous infusion (IV)     for five consecutive days every 28 days to patients with solid tumors refractory to current     therapies. There have been no previous human studies of intravenous (into one's vein) EM-1421     treatment; however, lab research (research in test tubes and/or animals) suggests that     EM-1421 has shown some activity against tumors in animals. This activity in animal models     suggests that EM-1421 may be a useful chemotherapy for human cancer.      The primary objective of this study is to determine the safety and maximum tolerated dose of     EM-1421 given by intravenous infusion. The efficacy of the treatment will also be measured.   "
184665|NCT00259831|"     The purpose of the Study is to determine the prophylactic effects of CVT-E002 treatment for     upper respiratory tract infections in healthy adult employees working with residents in     continuing care facilities. It is hypothesized that the use of CVT-E002 will effectively     reduce the incidence, severity and duration of upper respiratory infections among the     participants when compared to placebo.   "
184666|NCT00259844|"     This study will test the safety and efficacy of TroVax in patients undergoing surgical     resection of colorectal cancer with liver metastases.      TroVax potentially works by encouraging the immune system to react against the 5T4 protein on     the surface of bowel cancer cells. The immune system is then able to recognise 5T4 and kill     cells that carry it. The hope is that if tumour cells started to grow again after the main     tumour has been surgically removed, the immune system would be able to find and destroy them.   "
184667|NCT00259857|"     We have previously evaluated the safety and efficacy of Alendronate in 10 patients with     juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate     improved BMD of the spine and hip without any major side effects. There were no additional     fractures during therapy. The present study is designed to further evaluate the safety and     efficacy of Alendronate in 20 children with juvenile osteoporosis using a double-blind,     randomized, placebo-controlled, cross-over protocol.   "
184668|NCT00259870|"     This is a two part study designed to evaluate the safety and efficacy of SB-773812 in the     treatment of acute schizophrenia. Subjects with acute schizophrenia will be randomized in an     adaptive design study to receive placebo, SB-773812 60mg or olanzapine 15mg for 12 weeks in     Part A. An interim analysis will be conducted to assess the efficacy and safety of the     SB-773812 60mg dose compared with placebo. Based on these data, up to two further doses of     SB-773812 will be added to the randomization for Part B.   "
184669|NCT00259883|"     This study was designed to assess the efficacy and safety of combination therapy of PAXIL and     benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or     depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in     the symptoms of depression will be evaluated by use of the rate and extent of decrease in     Hamilton Rating Scale for Depression (HAM-D).   "
184670|NCT00259896|"     This study is a placebo-controlled study in both healthy normal subjects and patients with     Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is     given for 7 days, and to assess the impact this medication has on various substances in the     blood. Assessments include repeat blood sampling and monitoring of any side effects.   "
184671|NCT00259909|"     The primary objective of the study is to validate the questionnaire in patients who have     sudden, sustained worsening of their baseline condition commonly known as chronic obstructive     pulmonary disease (COPD).   "
184672|NCT00259922|"     Adults who are taking opioid therapy for persistent non-cancer pain and have resulting     opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms,     or to placebo. The primary objective of this phase 3 confirmatory study is to compare     alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is     based on frequency of bowel movements. Subjects will be required to: (1) track their bowel     movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.   "
184673|NCT00259935|"     The purpose of this study is to determine the bioequivalence of the new oral capsule     formulation to the currently used oral capsule formulation of topotecan.   "
184674|NCT00259948|"     The purpose of this study is to examine the effect of Aerobic Physical Activity on the     function of the Autonomic System in patients after Myocardial Infarction or Stroke.      A secondary objective is to examine whether it is possible to predict which of the patients     will most benefit from physical activity (exercise training), taking into account, genetic     factors such as Polymorphism of ACE (Angiotensin Converting Enzyme)   "
184916|NCT00257140|"     The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an     antibiotic, compared with cefaclor, another antibiotic, in the treatment of adults with     chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.   "
184675|NCT00259961|"     Long-term results following laparoscopic and open Nissen fundoplication for     gastro-oesophageal reflux will be objectively assessed in a selected population of patients     already included in a randomized controlled trial comparing the two different techniques. The     presence of postoperative symptoms will be evaluated by an independent clinician using an     objective questionnaire. The recurrence of gastro-oesophageal reflux will be studied by     24-hours pH study. Furthermore the presence of gastric motility disorders will be studied by     electrogastrography and 13C-octanoic acid breath test.   "
184676|NCT00259974|"     Polyneuropathy associated with anti-MAG monoclonal IgM gammopathy is responsive of mainly a     sensory deficit in predominantly males ,aged 40-70 years. Significantly high serum anti-MAG     antibodies are linked with demyelinating features of the peripheral nerves.Rituximab, an     anti-CD 20 monoclonal antibody is a new drug which reduces B-lymphocytes. This study will     test the safety and efficacy of rituximab in the treatment of patients with anti-MAG     polyneuropathy.   "
184677|NCT00259987|"     This Phase II study will assess the efficacy, safety, and pharmacodynamics and     pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with     relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric     cardia.   "
184678|NCT00260000|"     The main purpose is to test whether treatment with BH4-tablets can replace the protein     restrictive diet in patients with mild PKU caused by a certain frequent mutation.   "
184679|NCT00260013|"     The objective of the Transition into Primary-care Psychiatry (TIPP) project is to determine     how feasible it is to conduct a study to evaluate a new primary-care focused program of     mental health care delivery for people with chronic mental illness. This will be done by     comparing a primary-care based collaborative, interdisciplinary model to care-as-usual on     health related quality of life, client symptomatology, client's perceived need of care,     participant satisfaction and cost-effectiveness.   "
184680|NCT00260026|"     Researchers from Memorial Sloan-Kettering Cancer Center are conducting a research study on a     Chinese herbal medicine known as Jin Fu Kang. We want to see if this can help patients with     advanced lung cancer. Jin Fu Kang might reduce the growth of cancer or improve quality of     life. You are eligible for this trial because your cancer has progressed after prior     chemotherapy and your doctor has recommended further chemotherapy treatment.      Lung cancer that has been confirmed and that has spread is called advanced cancer. There is     no known permanent cure for advanced lung cancer, but chemotherapy may temporarily shrink the     cancer and improve the quality of patients' lives.   "
184681|NCT00260039|"     This dose-ranging study is to evaluate an investigational vaccine with the following     objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate     immune responses in women who are between 16 and 23 years of age at enrollment.   "
184682|NCT00260052|"     To determine if the early administration of erythropoietin to patients sustaining traumatic     brain injury will reduce secondary brain injury.   "
184683|NCT00260065|"     The purpose of this study is to determine the overall response rate in patients with     myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.   "
184684|NCT00260078|"     Limited data exist about combination anti-HIV treatment regimens in children, including how     those drugs are cleared by the body in children. The purpose of this study is to measure the     blood levels of the following combinations of anti-HIV drugs in HIV infected chilren:     tenofovir disoproxil fumurate (TDF) and efavirenz (EFV) or nevirapine (NVP); TDF and     darunavir (DRV) with or without EFV; and TDF and ritonavir (RTV) with or without EFV.   "
184685|NCT00260091|"     The purpose of this randomized prospective clinical trial is to determine whether an     infertility treatment that moves quickly to In Vitro Fertilization (IVF) is more cost     effective than the usual treatment strategy which includes various combinations of     infertility drugs and intrauterine insemination (IUI) prior to utilizing In Vitro     Fertilization.   "
184686|NCT00260104|"     It would be useful to study coronary arteriovenous difference of various markers in patients     who are undergoing coronary angiography for suspected coronary artery disease. Environmental     and genetic factors may play a role in the progression of coronary artery disease. The goal     of this project is to establish a series of cross-sectional / case-control studies to     evaluate risk factors of coronary artery disease in China.   "
184697|NCT00262821|"     This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to     see how well they work compared to cisplatin and radiation therapy in treating patients with     cervical cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Internal     radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.     Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy. It is     not yet known whether giving cisplatin together with radiation therapy is more effective with     or without tirapazamine in treating cervical cancer.   "
184698|NCT00262834|"     This phase II trial is studying how well vorinostat works in treating women who are     undergoing surgery for newly diagnosed stage I, stage II, or stage III breast cancer.     Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving vorinostat before surgery may shrink the tumor so that it can be removed.   "
184699|NCT00262847|"     This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how     well they work compared to carboplatin, paclitaxel, and placebo in treating patients with     stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs     used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to     grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are     more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial,     primary peritoneal, or fallopian tube cancer.   "
184965|NCT00267189|"     The purpose of the study is to assess the effect of everolimus initiation together with     reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance     liver transplant recipients with CNI-related renal impairment, while maintaining efficacy.   "
184687|NCT00260117|"     Each year, a significant portion of men and women who engage in physical activities such as     walking or running reduce their activity and by doing so place themselves at greater risk of     obesity, heart disease, and diabetes. Our own prospective epidemiological studies of runners     and walkers suggest that during 7.6 years of follow-up over 40% have reduced their mileage by     half or more. Research suggests that social support, perceived health benefits, resiliency to     interruptions in training, and exercise self-efficacy predict successful maintenance. We have     found that runners who successfully maintained or increased their running mileage during this     follow-up were more likely to have participated in social events such as marathon,     half-marathon, or 10km races.      The purpose of this study is to build upon our current Internet-based survey tools     (www.healthsurvey.org) for tracking physical activity and nutrition on full-function activity     and diet logs. The existing software allows participants to visualize their accumulated     running and walking mileage on a virtual transcontinental route starting in Yorktown,     Virginia and ending in Florence, Oregon. To the existing software, we will add the ability     to: 1) choose named or anonymous running and walking partners with similar goals and     abilities to travel with (or race against) along the transcontinental trail, 2) communicate     with partners to provide mutual support, 3) compete as part of virtual running and walking     teams created by the user, and 4) be recognized for completing each state on an awards page     (optional). Interest in the site will be maintained by providing regular updates on     scientific research on running and walking through our proprietary software. The updates will     be created from PubMed abstracts that are made more reader friendly by defining all     scientific terms in pop-up balloons.   "
184688|NCT00262691|"     Cardiovascular disease is a complex multifactorial and polygenic disorder that is thought to     result from an interaction between a person's genetic make up and various environmental     factors. Although many studies have revealed that several genetic variants increase the risk     of cardiovascular disease, the results of these studies remain controversial. The purpose of     this study is to identify polymorphisms that confer susceptibility to cardiovascular disease     and to clarify the adequacy of reported susceptibility gene polymorphisms. To complete this     purpose, we will prospectively study over 5,000 local residents in whom relationship between     these polymorphisms and occurrence of cardiovascular disease over 5 years.   "
184689|NCT00262704|"     This randomized trial will test the hypotheses that (a) a physician opinion leader     intervention, (b) a narrative process trace physician feedback intervention, or (c) the     combined intervention (a + b), are no more effective than (d) usual care in improving the     clinical care of adult patients with type 2 diabetes.   "
184690|NCT00262717|"     To compare two commercially available platforms for assessment of HIV drug resistance to     determine which provides superior virological results.      We hypothesise that one test will be significantly superior to the other.   "
184691|NCT00262730|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Biological therapies, such as     poly ICLC, may stimulate the immune system in different ways and stop tumor cells from     growing. Giving poly ICLC after radiation therapy and temozolomide may stop any remaining     tumor cells from growing.      PURPOSE: This phase II trial is studying how well giving radiation therapy together with     temozolomide followed by temozolomide and poly ICLC works in treating patients with newly     diagnosed glioblastoma multiforme.   "
184692|NCT00262743|"     RATIONALE: Green tea extract contains ingredients that may slow the growth of certain     cancers.      PURPOSE: This phase I/II trial is studying the side effects and best dose of green tea     extract and to see how well it works in treating patients with stage 0, stage I, or stage II     chronic lymphocytic leukemia (CLL).   "
184693|NCT00262769|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It     is not yet known whether gemcitabine is more effective with or without cisplatin in treating     cholangiocarcinoma or biliary tract tumors.      PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how     well they work compared to gemcitabine alone in treating patients with unresectable locally     advanced or metastatic cholangiocarcinoma or other biliary tract tumors.   "
184694|NCT00262782|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Sometimes, the cancer may not need treatment until it progresses. In this case, observation     may be sufficient. It is not yet known whether fludarabine is more effective than observation     in treating chronic lymphocytic leukemia.      PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works     compared to observation only in treating patients with stage 0, stage I, or stage II B-cell     chronic lymphocytic leukemia.   "
184695|NCT00262795|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. It is not yet known whether fludarabine is more effective than     chlorambucil in treating chronic lymphocytic leukemia.      PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as     first-line therapy compared to chlorambucil in treating older patients with previously     untreated chronic lymphocytic leukemia.   "
184696|NCT00262808|"     RATIONALE: Colony-stimulating factors, such as GM-CSF, may increase the number of immune     cells found in bone marrow or peripheral blood and may help the immune system recover from     the side effects of chemotherapy or kill tumor cells. Drugs used in chemotherapy, such as     fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy     after surgery may kill any remaining tumor cells. Sometimes, after surgery, the tumor may not     need additional treatment until it progresses. In this case, observation may be sufficient.      PURPOSE: This phase II trial is studying how well GM-CSF and combination chemotherapy work in     treating patients who are undergoing surgery for stage II or stage III colon cancer.   "
184711|NCT00263016|"     Primary Objective:        -  To compare the tumour response rate of combination chemotherapy irinotecan/cisplatin          (IC) versus docetaxel/cisplatin (DC) in advanced NSCLC patients who responded to 3          courses of docetaxel/cisplatin.      Secondary Objectives :        -  To compare the time to progression after chemotherapy treatment between the IC and DC          arms of treatment.        -  To compare the toxicity profile of the IC and DC arms of treatment.   "
184712|NCT00263029|"     The purpose of this phase II trial is to determine the efficacy and safety of the combination     of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced     cancers of the rectum.   "
184700|NCT00262860|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may     kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine     hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.   "
184701|NCT00262873|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with     myelodysplastic syndromes.   "
184702|NCT00262886|"     RATIONALE: A peripheral stem cell transplant or bone marrow transplant from a brother or     sister may be an effective treatment for kidney cancer.      PURPOSE: This phase II trial is studying how well a donor peripheral stem cell or bone marrow     transplant works in treating patients with relapsed or refractory metastatic kidney cancer.   "
184703|NCT00262899|"     RATIONALE: Genetics education and counseling may help patients make treatment decisions. It     is not yet known how genetic counseling or usual care influence patient treatment decisions     for breast cancer.      PURPOSE: This randomized clinical trial is studying how well genetic counseling works     compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ,     stage I, stage II, or stage IIIA breast cancer make treatment decisions.   "
184704|NCT00262925|"     This phase II trial is studying how well giving combination chemotherapy together with     alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic     leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as     alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer     cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. Giving combination chemotherapy together with alemtuzumab may kill more     cancer cells.   "
184705|NCT00262938|"     RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of     life of obese endometrial cancer patients and may help them live longer and more comfortably.      PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary     counseling on weight loss and quality of life of obese patients with stage I or stage II     endometrial cancer in remission.   "
184706|NCT00262951|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.     Radiation therapy uses high-energy x-rays to kill tumor cells. Interferon alfa may interfere     with the growth of tumor cells. Giving combination chemotherapy and radiation therapy     together with interferon alfa before surgery may shrink the tumor so it can be removed.     Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy and     radiation therapy together with interferon alfa works in treating patients with locally     advanced pancreatic cancer that cannot be removed by surgery.   "
184707|NCT00262964|"     The primary goal of this study is to provide a better understanding of: 1) the pathogenesis     and pathophysiology of non-alcoholic fatty liver disease (NAFLD) in obese subjects, and 2)     the effect of marked weight loss on the histologic and metabolic abnormalities associated     with NAFLD. The following hypotheses will be tested:        1. obesity causes hepatic fat accumulation because of excessive fatty acid release from fat          tissue and increased free fatty acid availability,        2. increased hepatic (liver) fat content causes insulin-resistant glucose (sugar)          production by the liver and altered liver protein synthesis,        3. increased hepatic fat content causes increased lipid (fat) peroxidation, hepatic          inflammation, necrosis and fibrosis, and        4. marked weight loss improves NAFLD once patients are weight stable.   "
184708|NCT00262977|"     Our aim is to determine if a patient-directed intervention is more effective than     computerized clinician reminders alone for improving aspirin use in adults with diabetes.   "
184709|NCT00262990|"     The objective of this study is to assess the safety and efficacy of patupilone compared to     pegylated liposomal doxorubicin. Additionally, this study will assess the ability of     patupilone to extend the survival time and potential beneficial effects in women who have     nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.   "
184710|NCT00263003|"     Study Objectives :        -  To demonstrate the reduction in office Blood Pressure following a 8-week regimen of          irbesartan / hydrochlorothiazide using irbesartan as a reference.        -  To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan          / hydrochlorothiazide using irbesartan as a reference.        -  To compare the response rate (defined as office Systolic Blood Pressure/Diastolic Blood          Pressure reduce more than 10mmHg from Week 0) of patients after 4-week and 8-week          regimen of irbesartan / hydrochlorothiazide versus irbesartan.        -  To compare the proportion of patients requiring titration after 4-week regimen of          irbesartan/hydrochlorothiazide versus irbesartan        -  To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus          irbesartan when administered once daily   "
184738|NCT00263380|"     Research on the synergistic effect of corticosteroids and beta-agonists on the cytokine     production in COPD patients. Blood will be obtained from healthy volunteers and COPD patients     and blood monocytes will be stimulated to produce cytokines with or without the prementioned     drugs.   "
184713|NCT00263042|"     The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI),     stroke, or death from an MI or stroke in patients with abdominal obesity with other     cardiovascular (CV) risk factors.      The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV     death, or CV hospitalization in these patients.   "
184714|NCT00263055|"     Safety & tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian     patients   "
184985|NCT00267449|"     The primary study endpoint -SoftScan adjunctive accuracy- will be used to test the hypothesis     that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic     accuracy that is significantly better than x-ray mammography alone.   "
184715|NCT00263068|"     This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM     936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal     dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the     Taper Period of SP792 are allowed to enroll in this trial.      All subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2     patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments,     initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of     6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days), although     not all subjects will require 28 days to reach their optimal dose.      A subject's dose may be increased or decreased, as needed by the investigator to maintain a     subject's effective dose during the Maintenance Period. A Taper Period is provided to allow     for safe, gradual withdrawal from trial medication   "
184716|NCT00263081|"     The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily     (QD), to lower cholesterol in subjects with homozygous familial hypercholesterolemia     undergoing lipid-lowering treatment.   "
184717|NCT00263094|"     Fasting is a known trigger for headache. People who fast to comply with religious edict have     been shown to be prone to headache which becomes more likely to occur with increasing length     of fasting, and in people prone to headache. This has been documented as 'Yom Kippur     Headache' and 'First of Ramadan Headache.' We performed a study to test the hypothesis that     Rofecoxib, a pain medicine and anti-inflammatory, with a prolonged duration of action would     prevent or attenuate headache when taken just prior to the complete (no food or drink) 25     hour fast of Yom Kippur.   "
184718|NCT00263107|"     Telerounding is the use of wireless remote video-confrencing to assess hospitalized patients.     Physicians thus rely on all ususal data collected during bedside rounds with the exeption of     a direct physical exam. The intention of this study is to determine if post-operative     morbidity can be identified in an accurate and timely manner.   "
184719|NCT00263120|"     The thymus is known to be the site of T cell development in humans. Due to its location in     the chest in front of the heart, incidental thymecomy is commonly performed during     cardiothoracic surgery, especially in infants and children, so that surgeons may gain access     to the surgical field. This practice has been considered safe because it was thought that the     thymus is inactive after birth. However, recent data using newly developed techniques has     demonstrated that the thymus normally is active well into adulthood. In addition, in a     previous study (UCLA IRB # 02-03-008-02) we have demonstrated alterations in lymphocyte (T     cells) number in individuals who have undergone thymectomy in childhood but we do not know     how immunity is affected. We plan to investigate if immune development or immune function     later in life is affected by the loss of T cell production caused by thymectomy during     cardiothoracic surgical procedures in childhood. At UCLA, a large number of patients are seen     who have congenital heart disease and undergo surgical procedures for correction or repair     and many children and adults are followed for many years after they have undergone surgical     procedures. Subjects for study will be recruited from among these patients.      We propose a study which will examine the number and activity of lymphocytes obtained from     blood samples from child and young adult subjects who have undergone surgery in early     childhood. We will determine if these subjects have had complete thymectomy in the past using     CT or MRI (obtained during routine care) or, for subjects who are having cardiothoracic     surgery, by visualization of thymic tissue during the procedure. In addition we will give     vaccination for a common viral illness (hepatitis A) and measure immune responses to it (from     a blood sample). As part of this study, we will ask for medical information consisting of a     history of congenital cardiac disease and other diagnoses (such as asthma), a history of     infections and hospitalizations, and information about immunizations. We will also ask about     a list of specific symptoms which will give us information about the function of the immune     system.   "
184720|NCT00263133|"     12 normal healthy controls will be treated with 50 mg sertraline once daily for three weeks.     Early amplitudes of visually evoked potentials will be examined at day 0, 10 and 21 and     statistically compared. This study aims to examine a putative modulation of synaptic     transmission and plasticity by an antidepressant and is part of a series of studies in     healthy individuals and depressed patients.   "
184721|NCT00263146|"     Acute Respiratory Distress Syndrom is associated to lung and systemic inflammation, which     could be worsened by mechanical ventilation.This included a proteasis - antiproteasis     imbalance which could participate to a fibrosis process.      Low tidal-volume ventilation (6 mL/kg) with low plateau pressure (< 30 cm H2O) has been     proved to decrease mortality when compared with more conventionnal high-volume (12 mL/kg)     ventilation.Moreover, this lung-protective approach decrease lung annd systemic inflammation.      Using recruitment maneuvers (i.e. the application during a short time of high pressures with     the intention to re-open the lung, followed by an increase of PEEP-level to keep the lung     open, in an attempt to decrease the alveolar shear-stress) has been proposed to improve     oxygen and to reduce bio-trauma.      However, the effect of such maneuvers on the inflammatory response and on the evolution of     ARDS remains unknown.      Therefore we have planned a randomized, monocentric, controlled trial consisting of the     comparison of two approaches of mechanical ventilation in Acute Lung Injury. This trial will     include 30 hemodynamically stable patients fulfilling the ALI or ARDS criteria defined by the     US and European Consensus Conference.      They will be randomized in two groups: standard low-volume ventilation vs. recruitment     maneuvers.      The main objective of our study is to compare both ventilatory strategies in termes of lung     and systemic inflammation.      The primary outcome measures will be the proteasis activity as measured in broncho alveolar     fluid (BAL) and pro- and antiinflammatory cytokines activity as measured in the BAL and in     the blood. Two samples (BAL and blood) will be obtained at a 48-72 hours interval. In the     recruitment maneuver group, the first BAL will be obtained two hours before the maneuver.      Secondary outcome measures will be gaz exchange, respiratory mechanics, systemic hemodynamics     and visceral dysfunction scores.   "
184722|NCT00263159|"     The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity     of pharmaceutical care for asthma patients.   "
184723|NCT00263172|"     The primary purpose of this study was to compare weight loss achieved through a behavioral     online intervention vs. a commercial self-help website. The investigators hypothesized that     there would be no difference in weight loss between groups.   "
184724|NCT00263185|"     The purpose of this study is to determine whether Vitamin D supplementation reduces the     symptoms of muscle stiffness and joint tenderness that some patients may develop after     starting therapy with Anastrozole for breast cancer.   "
184725|NCT00263198|"     The purpose of this study is to test the safety of PTK787/ZK222584 and Letrozole when given     in combination, and to see what effects they have on breast cancer that has metastasized.   "
184726|NCT00263211|"     The purpose of this study is to determine the effects of Plavix and aspirin in women with     metastatic breast cancer.   "
184839|NCT00264732|"     The purpose of this study is to evaluate the efficacy and safety of amolimogene, in the     treatment of patients with high-grade cervical intraepithelial lesions of the uterine cervix.   "
184807|NCT00264316|"     The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is     limited by postinfarction left ventricular (LV) dysfunction.The purpose of this study is to     determine whether intracoronary transfer of bone marrow cells will augment left ventricular     function recovery of the heart.   "
194178|NCT00387582|"     This study will evaluate the clinical efficacy of intra-vitreal injections of Ranibizumab     (Lucentis) in the treatment of Diabetic Macular Edema as compared to grid/focal laser.   "
184727|NCT00263237|"     This study will determine whether an experimental medicine, STA-5326 mesylate, is safe to use     in patients with common variable immunodeficiency (CVID) who have inflammation of the gut. It     will also determine if patients who take this drug show improvement in their symptoms,     decrease in inflammatory chemicals in the gut, changes in their immune cells, and improvement     in how their gut is functioning to absorb food.      Patients between 18 and 75 years of age with CVID and chronic diarrhea or involuntary weight     loss of more than 5 percent of their past body weight over the past 12 months may be eligible     for this study. Candidates are screened with a review of their medical records, a medical     history and physical examination, blood, urine and stool tests, chest x-rays and skin test     for exposure to tuberculosis, and a hydrogen breath test. For the latter, breath samples are     collected before and every 20 minutes (for 2 hours) after the subject drinks a sugar     solution. This test determines the digestive effects of bacteria in the upper intestine.     Samples are collected by having the subject blow into a balloon.      Participants undergo the following tests and procedures:      Immune System and Gastrointestinal Evaluation        -  48-hour stool fat collection (measures the amount of undigested fat in the stool):          Subjects keep a diary of what they eat for a 48-hour period. At the beginning of the 48          hours they take two dye capsules and then take another two capsules 48 hours later. They          collect a stool sample when they pass the second set of capsules in their bowel          movement. An additional 24-hour stool collection is tested for loss of protein in the          stool.        -  D-xylose absorption test (measures the ability of the gut to absorb nutrients): Subjects          drink a solution of d-xylose (a sugar substitute). Blood samples are collected before          and 1 hour after drinking the solution.        -  Upper endoscopy: A thin flexible lighted tube is advanced through the mouth to evaluate          the esophagus, stomach and beginning of the small intestine.        -  Lower endoscopy: A thin flexible lighted tube is advanced through the rectum to evaluate          the colon.      Treatment Period (Study days 1 to 57)        -  Physical examination - study days 1, 8, 15, 29, 43 and 57        -  Blood samples to test the levels of STA-5326 in the blood. On study days 1 and 57,          samples are collected before the medication dose and 1, 2, 4, 6 and 8 hours after the          dose; on day 29, one sample is collected before the medication dose.        -  Blood samples for routine safety testing - study days 1, 8, 15, 29, 43 and 57        -  Medication history - study days 1, 8, 15, 29, 43 and 57        -  Interview about pain, discomfort, and well being - study days 1, 8, 15, 29, 43 and 57        -  Pregnancy test for women who can become pregnant - study days 15, 43, and 57        -  D-xylose absorption test - study days 29 and 57        -  Electrocardiogram - study days 29 and 57        -  Urine test - study days 29 and 57        -  Blood test for research on immune cells - study day 57        -  Repeat endoscopies and studies of gut function (24- and 48-hour stool collections)      Follow-up period (Day 85 and day 113)      -Physical examination, blood tests, medication history, questions about pain, discomfort and     well being   "
184728|NCT00263250|"     This is a multicenter clinical trial to compare pain, physical function, and other outcomes     in men with asymptomatic or minimally symptomatic inguinal hernias randomly assigned to     watchful waiting without an operation, or a standard hernia repair with mesh. We studied the     safety of delaying operation.   "
184729|NCT00263263|"     Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in     native coronary arteries reducing the occurrence of restenosis and repeated     revascularization, however saphenous vein grafts have been always excluded form randomized     trials.      Objective: To evaluate the angiographic and clinical impact of sirolimus-eluting-stents with     respect to bare-metal-stents in degenerated vein grafts.      Design: Double-blind randomized controlled non-industry-sponsored trial.      Setting: A single-center tertiary-care referral hospital.      Patients: All patients are randomly allocated to sirolimus-eluting-stent implantation or the     corresponding bare-metal-stent. All patients are followed clinically and repeated     angiographic follow-up is performed in all at 6-months.      Main outcome measure: Primary end-point is 6-months angiographic in-stent late loss.     Secondary end-points include: binary angiographic in-stent and in-segment restenosis,     intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events     (death, myocardial infarction, target-lesion and target-vessel revascularization).   "
184730|NCT00263276|"     The purpose of this clinical research study is to learn if BMS-512148 is effective in     controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients     who have been diagnosed with Type 2 diabetes. Patients should first try to control their     diabetes with diet and exercise and should not have previously been treated for their     diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be     studied   "
184731|NCT00263289|"     Nitrous oxide analgesia is used routinely for the dental treatment of anxious or     uncooperative pediatric patients. In many instances it is used alone without any supplemental     oral premedication. A controversy exists among pediatric dentists and pediatric dental     departments regarding the need to apply pre-procedural fasting (PF) or other limitations on     children undergoing dental treatment with nitrous oxide alone.The purpose of this study is to     investigate the association between PF and the frequency of vomiting in pediatric patients     receiving dental treatment with nitrous oxide analgesia.   "
184732|NCT00263302|"     The purpose of this study is to determine whether glucocorticoids have potent diuretic     effects in patients with congestive heart failure.   "
184733|NCT00263315|"     A Phase II/III randomized double-blind study comparing the safety and the efficacy of a     weekly administration of 25 mg nebulized AmBisome with nebulized placebo solution to prevent     invasive pulmonary aspergillosis in neutropenic hemato-oncologic patients.   "
184734|NCT00263328|"     A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune     system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study     A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months     posttransplant. Patients who completed study A3921009 were offered the opportunity to     participate in study A3921021 which will extend the evaluation of safety and efficacy of     CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control     arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects     will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be     discontinued.   "
184735|NCT00263341|"     The purpose of this 1-year study is to evaluate the efficacy and safety of a new     contraceptive vaginal ring (CVR) delivering low doses of Nestorone (NES), a new,     nonandrogenic progestin, and ethinyl estradiol (EE), an estrogen used in oral contraceptives.     The CVR, which is made of silicone rubber, is designed to be used for 1 year (13 menstrual     cycles) before replacement is required.   "
184736|NCT00263354|"     To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in     patients with advanced unresectable or metastatic gastric cancer.   "
184737|NCT00263367|"     This study will look at the changes taking place in the blood levels of key markers of     oxidative stress. Oxidative stress is the biological equivalent of rust on a car. It changes     vital cell chemistry. It is known to occur at high pressure oxygen, but little is known about     changes at pressures slightly greater than normal atmospheric pressure.      Hyperbaric therapy is used in a variety of medical conditions. It is being tested in this     study only for safety. It is not being assessed for the ability of hyperbaric oxygen to     improve the clinical condition of children with autism.      This study was felt to be important since autism appears to be associated with oxidative     stress and hyperbarics was being used off-label for this condition without safety studies.   "
184951|NCT00265564|"     This study proposes a prospective program of research that will identify feasible and     inexpensive methods to detect and treat comorbid PTSD among VA SUD patients, thereby     improving substance abuse treatment outcomes.   "
184739|NCT00263393|"     This study will evaluate the effectiveness of a novel cardiovascular disease prevention     program designed for delivery through existing primary health care services in rural villages     in Andhra Pradesh.      The primary aim is to increase the number of high-risk individuals in the population that are     appropriately managed with proven, low-cost preventive interventions. The corresponding null     hypothesis is therefore that the prevention program will result in no change in the     proportion of high-risk individuals identified and treated in villages assigned to     intervention compared with those villages assigned to control.   "
184740|NCT00263406|"     Randomisation between postoperative administration of an ACE-inhibitor or not.   "
184741|NCT00263419|"     The purpose of this study is to determine whether a structured stress relief management     program can prevent the progression of late diabetic complications in patients with type 2     diabetes.   "
184742|NCT00263432|"     Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries to obtain     a repair and prevention of secondary osteoarthritis   "
184743|NCT00263445|"     Serum insulin-like growth factor-I (IGF-I) measurements have been shown to correlate well     with growth hormone action and effect, and recent data show that serum IGF-I may be related     to safety and efficacy of growth hormone (GH) treatment in patients. Some studies indicate     that high IGF-I levels are associated with increased cancer risk, and low IGF-I levels are     associated with increased risk for cardiovascular disease. Studies in children also show that     the serum IGF-I level is correlated with the change in height score achieved (that is, the     higher the IGF-I level, the greater the gain in height). Pediatric endocrinologists have     therefore begun to use serum IGF-I levels, in addition to growth rate and weight gain, to     adjust the GH dose in treated children.      Although monitoring of serum IGF-I levels is becoming standard of care in patients begin     treated with GH, there are few guidelines regarding the actual logistics of adjusting GH     dose. As serum IGF-I level has been linked to both safety and efficacy of GH treatment, the     ideal practice would be to maintain serum IGF-I levels within a certain target range. The     overall goal of our study is to construct a mathematical model which predicts the change in     GH dose necessary to achieve a desired change in IGF-I level.      Hypotheses to be tested by our study include the following: IGF-I measurement has a role in     optimization of GH therapy; GH dose change to achieve IGF-I changes are predictable; and     gender and puberty affect the relationship between dose change and target IGF-I changes.   "
184744|NCT00263458|"     The purpose of this study is to assess the feasibility, cost, and effectiveness of a model of     care designed to integrate buprenorphine treatment for opioid dependence into the HIV primary     care clinics at the UCSF Positive Health Program.   "
184745|NCT00263471|"     7-methylxanthine has been shown to increase the concentration and thickness of collagen     fibrils in rabbit sclera. Deficient collagen in the sclera may be the cause of progression of     childhood myopia. The study hypothesis is that treatment with 7-methylxanthine will stabilize     the sclera and prevent further progression of myopia.   "
184746|NCT00263484|"     The purpose of this study is to determine whether lower than conventional doses of     dexamethasone and thalidomide; and a higher dosing frequency of zoledronic acid are effective     in the treatment of newly-diagnosed multiple myeloma.   "
184747|NCT00263497|"     Most trauma survivors in low-income countries develop post-injury chronic pain syndromes.     Normally traumatic amputees have to wait 4-6 months for definitive prosthesis fitting. The     actual study aims at reducing post-injury chronic pain and improving function by immediate     temporary prosthesis fitting after surgery.   "
184748|NCT00263523|"     This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI)     to measure a serotonin receptor subtype in the brain called 5-HT(1A). This receptor is a     target for drug therapy to treat anxiety and depression. The study will see if a newly     developed radioligand (radioactive substance used in PET scanning to study the receptor     systems of the brain) called [(11)C](-)-RWAY is more effective than other radioligands     currently used in brain receptor research.      Healthy subjects 18-40 years of age may be eligible for this study. Candidates are screened     with a physical examination, electrocardiogram, and blood and urine tests.      Participants undergo PET and MRI scanning as follows:      PET scan      PET uses small amounts of a radioactive chemical called a tracer (in this case,     [(11)C](-)-RWAY) that labels active areas of the brain. For the procedure, the subject lies     on the scanner bed. A special mask is fitted to the subject's head and attached to the bed to     help keep the head still during the scan so the images will be clear. A brief scan is done     just before the tracer is injected to provide measures of the brain that will help in the     precise calculation of information from subsequent scans. Then, the tracer is injected     through a catheter (plastic tube) placed in the arm and pictures are taken for about 2 hours,     while the subject lies still on the scanner bed. Subjects return to the clinic for blood and     urine tests 24 hours after the scan.      MRI      The MRI scan is done within 1 year of the PET scan. MRI uses a magnetic field and radio waves     to produce images of body tissues and organs-in this case, the brain. The subject lies on a     table that is moved into the scanner (a tube-like device), wearing earplugs to muffle the     noise of the machine during the scanning process. The space in the scanner is confining and     may cause some people to be somewhat anxious. An intercom system allows the subject to speak     with the staff member performing the study at all times during the procedure, and the     procedure can be stopped at any time.   "
184749|NCT00263536|"     This study will examine whether family-based interpersonal psychotherapy (FB-IPT) is an     effective tool for helping pre-adolescent girls and boys at risk for become obese to reduce     weight gain. IPT is a time-limited group therapy for preventing and treating depression in     children. It is also effective for treating binge eating disorder in adults and has resulted     in weight maintenance or modest weight loss in obese adults. IPT focuses on improving how     people relate to one another by relating symptoms to personal problem areas and then     developing strategies for dealing with these problems. Girls and boys between the ages of     8-13 years of age who are in good general health with the exception of being overweight and     whose body mass index (BMI) is above the 85th percentile for their age and sex may be     eligible for this study. Candidates are screened with a physical examination, measurement of     their height and weight, blood and urine tests, a DEXA scan (x-ray scan that measures body     fat, muscle and bone mineral content), and questionnaires and an interview to obtain     information about the child's general health, social and psychological function, and eating     patterns. Parents are also screened for their health and are asked to give blood samples for     genetic studies and participate in a few questionnaires and interviews.      Participants are randomly assigned to participate in FB-IPT or a health education program.     Both programs involve 12 weekly visits. At the end of the study, the body weight and mood of     the girls and boys in both groups are compared.      Participants (a parent and their child) meet individually with the therapist for 12 sessions     (each approximately an 45 minutes ). Girls and boys offered FB-IPT have meetings in which     they develop strategies for dealing with the problems girls struggle with that may lead to     increased eating. Girls and boys in the health education group have meetings that focus on     teaching teens children to live healthier lives and review topics related to developing and     maintaining healthy eating and exercise.      All participants are evaluated at the end of the 12-week program and asked to return to the     NIH for follow-up visits at post treatment, 6 and 12 months following initiation of the     program.      Each child and parent will be compensated for their time and inconvenience with $40 for     completing all pre-program assessments, $40 for attending the 12 week follow-up visit, $40     for the 6 month follow-up visit, and $40 for the 1-year follow-up. Therefore, each child may     receive up to $160, and the participating parent may receive up to $160. If a child's second     biological parent is also willing to give a genetic sample and undergo interviews, the second     parent can also receive $40 for a single visit to the NIH.   "
184750|NCT00263549|"     The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic     Rhinoconjunctivitis   "
184751|NCT00263562|"     The painful episode is the most common problem experienced by children with sickle cell     disease. Although various treatments are available during painful episodes, the medication     most commonly given for pain is a pain medication such as morphine. Fluids are also used.     Even with these treatments, many children still have severe pain that is difficult to     control. In addition to pain medications, there are other medications that may be useful.     Methylprednisolone (solumedrol) and prednisone are a group of medications called steroids     that may be helpful for painful episodes. These medications are known to lower the amount of     inflammation (this means swelling, tenderness, and soreness) in the body. Because this     medication may help with your pain, you are being asked to be a part of this study. These     types of medications are used in other illnesses such as asthma, especially during times when     the illness has gotten worse.      The main purpose of this study is to see if the methylprednisolone and prednisone will lower     the amount of pain and the length of hospital stay.      In addition to the pain medication you will normally receive, you will be assigned to one of     2 groups: 1) the experimental group with the active form of the medicine, or 2) a comparison     group without the active form of the medicine. In either group, you will still receive all of     the treatments you would normally receive for a painful episode, including pain medicines and     fluids. You and your doctors will not know what group you will be assigned.      If you decide to be a part of the study the following will happen:      For the first 5 days, you will be asked to: 1) describe your current pain (0=no pain to 10=a     lot of pain), worst pain (0=no pain to 10=a lot of pain), least pain (0=no pain to 10=a lot     of pain), and the amount of pain relief (0=no relief to 10=complete relief); 2) describe any     signs or symptoms you feel, including filling out a pain scale form each day; 3) and take the     medicines for 5 days, either at home or when in the hospital. Thirty days after the study, a     study researcher will call and will ask questions about your pain, any painful episodes, and     any medications you had. If you are discharged home sooner than 5 days after the start of the     study, research staff will call you to ask you these questions, remind you to fill out your     pain forms, and remind you to take your medicine. If you are discharged home, you will be     given pain scales to fill out each day at home.   "
184752|NCT00263575|"     The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in     treating breakthrough pain episodes in opioid cancer patients who are using stable doses of     opioid medication.   "
184753|NCT00263588|"     Determine how safe and effective lapatinib is when used to treat patients with ErbB2     overexpressing breast cancer that has spread to the brain and is still progressing there even     after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic     radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for     safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during     the course of the study.   "
184754|NCT00263601|"     The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in     Allergic Rhinoconjunctivitis   "
184755|NCT00263614|"     To determine whether HBeAg-positive and HBeAg-negative patients with HBV DNA greater than or     less than 5 log10 and 4 log10 copies/mL, respectively, and with normal or minimally elevated     liver transaminases have histological evidence of active liver disease.   "
184756|NCT00263627|"     The aim of this clinical trial is to show safety and efficacy of the allergoid preparation of     birch pollen allergens in the treatment of birch allergic patients in a representative number     of patients.   "
184757|NCT00263640|"     The trial is performed to assess efficacy and safety of the Allergopharma house dust mite     allergoid in bronchial asthma.   "
184758|NCT00263653|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a     booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles,     mumps and rubella (MMR) vaccine, versus Hib-MenC only and MMR only, when given to healthy     subjects aged 13 to 14 months who were primed with 3 doses of Hib (as part of a DTPa     -containing vaccine) and MenC-CRM197.   "
184759|NCT00263666|"     The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK     Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines     including OPV in HIV positive infants. The Protocol Posting has been updated in order to     comply with the FDA Amendment Act, Sep 2007.   "
184760|NCT00263679|"     The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK     Biological's candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school     children and adolescents (9-13 years of age) previously vaccinated with five consecutive     doses of Pa-containing vaccine. The inclusion of hepatitis A vaccine (Havrix®) as a control     vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and     safety assessments.   "
184761|NCT00263692|"     The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals'     combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when     administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years     when co-administered with MMR vaccine in subjects who had previously received four doses of     Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.   "
184762|NCT00263705|"     Determination of guidelines regarding the use of adjuvant chemotherapy for early breast     cancer in this population of Patients over 70 years old.   "
184763|NCT00263718|"     The objective of the study is to compare the use of calcipotriol plus betamethasone     dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel     vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk     and/or limbs. Patients will be treated once daily for up to 8 weeks.      The primary response criterion is the number of patients with controlled disease at week 8.   "
184764|NCT00263731|"     The purpose of this study is to learn more about the metabolic properties of lung cancer     cells.   "
184765|NCT00263744|"     The primary objective of this study is to describe the safety of 40 mg MEDI-517, with a     control of aluminum hydroxide, when given to healthy adult women who have evidence of HPV-16     and/or HPV-18 DNA detected in cervical brushings.   "
184766|NCT00263757|"     This randomized, controlled trial is designed to test whether treatment of sleep disordered     breathing (SDB) with positive airway pressure (PAP) therapy alters the natural history of     atrial fibrillation (AF). Patients with recent AF who are now in sinus rhythm, and found to     have SDB (obstructive and/or central sleep apnea) by formal sleep study but without     complaints of daytime sleepiness, are randomized to PAP therapy to eradicate SDB or to usual     care (medical management as prescribed by the patient's cardiologist).   "
184767|NCT00263770|"     The purpose of the study is to compare the effectiveness of soft palatal implants with     placebo and continuous positive airway pressure treatment in obstructive sleep apnea.   "
184768|NCT00263783|"     To determine the safety profile of single and multiple doses of MEDI522 in patients with     refractory solid tumors.   "
184769|NCT00263796|"     To study the effect of oxytocin on face processing and response inhibition in autistic adults     by fMRI.   "
184770|NCT00263809|"     The primary objective of the study is to measure platelet corrected count increments and the     incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected     count increment measured 1-hour post transfusion in response to the infusion of platelet     concentrates treated with the Mirasol PRT System device (test product) versus untreated     (reference product).   "
184771|NCT00263822|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Sometimes after treatment, the tumor may not need additional     treatment until it progresses. In this case, observation may be sufficient. It is not yet     known whether erlotinib is more effective than observation after first-line chemotherapy in     treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.      PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works     compared to observation in treating patients who have undergone first-line chemotherapy for     ovarian cancer, peritoneal cancer, or fallopian tube cancer.   "
184772|NCT00263835|"     The purpose of this study is to modify and evaluate a culturally appropriate intervention     that is designed to improve diabetes self-care practices by enhancing the self-efficacy,     empowerment and diabetes knowledge among Latino adults over the age of 55 years.   "
184773|NCT00263861|"     RATIONALE: Learning about the side effects of chemotherapy may help plan treatment and may     help patients live more comfortably.      PURPOSE: This clinical trial is studying nerve function in older diabetic patients who are     undergoing chemotherapy for metastatic solid tumors.   "
184774|NCT00263874|"     This initial proof of concept, phase II study aims to assess the safety and efficacy of     UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary     Disease.   "
184775|NCT00263887|"     The goal of this trial was to explore the utility of evaluating emphysema progression through     CT scans measuring lung density during a 2 year period of weekly infusions of either placebo     or human alpha-1-antitrypsin (AAT; Prolastin®). Exacerbation data recorded in patient diaries     were also collected. All efficacy data were analyzed for potential use in evaluating     Prolastin efficacy in this and other clinical trials.   "
184776|NCT00263900|"     The aim of this study is to evaluate the impact of the use of a quick diagnostic test of     infection with RSV and influenza virus on the assumption of clinical responsibility of the     children consulting at the Paediatric Emergency Unit.   "
184777|NCT00263926|"     The trial is performed to assess efficacy and safety of a purified standardised wasp venom     preparation in wasp venom allergy   "
184778|NCT00263939|"     The purpose of the study is to determine the effectiveness of a home-delivered variant of the     chronic disease self management program in improving health outcomes in patients with chronic     conditions.   "
184779|NCT00263952|"     The trial is performed to assess efficacy and safety of a purified standardised bee venom     preparation in bee venom allergy   "
184780|NCT00263965|"     This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and     active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2     diabetes. After a 1-week enrollment period, a 3 week placebo single blind run in period and     1-week placebo single-blind baseline measurement period, the patients will be given the     investigational product for 16 weeks in a double blind fashion. Metformin will be titrated up     during the first 3 weeks of the double-blind period. The total study duration, including     enrollment, run-in, randomized treatment and follow-up, is 29 weeks.   "
184781|NCT00263978|"     Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood     and marrow transplantation. Treatment with currently available (Food and Drug Administration     [FDA] approved) agents fails in most cases. Recently conducted clinical studies indicate that     patients benefit from defibrotide, a non-FDA approved agent. This protocol has been developed     not with a research intent, but rather to ensure that defibrotide is used by the blood and     marrow transplant programs at Children's Healthcare of Atlanta and at Emory University in a     safe, effective and ethical manner.   "
184782|NCT00263991|"     Primary headache disorders are now accepted as physiological diseases, and advanced     imaging-techniques have demonstrated a migraine generator in the brain stem and increased     stimulus sensitivity in these patients. The underlying neuronal dysfunctions remain to to     clarified and the existing neurophysiological methods have not yet been useful. More     sensitive and reliable methods are therefore highly needed. The aims of the study are     therefore to develop a sensitive and reliable method to demonstrate a cortical reorganisation     and expansion of pain sensitive cortical areas in patients with migraine or tension-type     headache.   "
184783|NCT00264004|"     The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be     well tolerated without significant drug withdrawal when accompanied by a suitable     hypertension management strategy or dose reduction.   "
184784|NCT00264017|"     In the past ten years, newer drugs with more selective affinity for the alpha-receptor have     been introduced. Alfuzosin (Uroxatral) and Tamulosin(Flomax are two second generation     alpha-blockers. In the course of our clinical proctice, both drugs have been used routinely.     This retrospective comparison is intended to be a priliminary comparison of their     effectiveness and side effects.   "
184785|NCT00264030|"     The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial     reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.   "
184786|NCT00264043|"     The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx     Velocity™ on patient outcome at one month.   "
184787|NCT00264056|"     The incidence of malignant melanoma continues to rise throughout the world. Approximately 12     in 100,000 Germans are diagnosed with malignant melanoma per year. Malignant melanoma is     often very aggressive since it may spread both through the lymphatic system and the     bloodstream at an early stage of disease.      While treatment of localized disease is mostly surgical, in patients with extensive disease,     prognosis remains poor; the primary standard therapy of metastastic disease comprises     dacarbazine (DTIC) eventually combined with other chemotherapeutic agents e.g., cisplatin or     BCNU. The duration of response to systemic chemotherapy is generally short and so far, no     standard second-line treatment has been established.      To study the potential additional therapeutic effects of regional hyperthermia in advanced     malignant melanoma patients with progressive chemotherapy refractory soft tissue metastases,     in the present trial, we sought to compine local hyperthermia with concomitant systemic     second-line chemotherapy.   "
184788|NCT00264069|"     The purpose of this study is to find out how well new treatment plans are followed by     outpatients with major mental illnesses (schizophrenia, bipolar disorder, depression,     personality disorder) and to determine the relationship between a diagnosis of schizophrenia     and compliance with a treatment plan.   "
184789|NCT00264082|"     The purpose of this research study is to evaluate the usefulness of the TRAP protein as (1)     an early indicator of bone destruction and (2) a tool for assessing the effect of Zometa® in     treating symptoms of bone metastases due to breast cancer. Tartrate-resistant acid     phosphatase (TRAP) is a protein released into the blood stream as a result of bone     destruction caused by metastasis of breast cancer to the bone. Bone destruction causes pain     and bone fractures. This study will measure TRAP levels in serum taken from breast cancer     patients to see if TRAP levels will be able to predict the effect of Zometa® treatment on     bone destruction, pain and bone fractures.   "
184790|NCT00264095|"     The purpose of this study is to observe the methods used to manage blood loss in surgical     procedures to remove tumors from patients with cancer and to determine if there is a     relationship with the need for blood transfusions.   "
184791|NCT00264108|"     The purpose of this study is to evaluate the cost-effectiveness of epoetin alfa compared with     darbepoetin alfa in the treatment of anemia in adults receiving chemotherapy for cancer.     Epoetin alfa and darbepoetin alfa are genetically engineered proteins that stimulate red     blood cell production.   "
184792|NCT00264121|"     The purpose of this study is to determine the incidence of congenital undescended testis of     mature boys, at one year of age, born in the Medical Centre Alkmaar (MCA).   "
184793|NCT00264134|"     Primary Objective: To determine the maximum tolerated dose of docetaxel when given with     Irinotecan and Carboplatin for the treatment of inoperable lung cancer.      Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in     patients with inoperable lung cancer.   "
184794|NCT00264147|"     To assess the clinically active dose range of study medication in the treatment of patients     with rheumatoid arthritis.   "
184795|NCT00264160|"     This open-label, multicenter trial will evaluate the efficacy and safety of treatment with     AMN107 in chronic myelogenous leukemia (CML) patients that are resistant and/or intolerant to     imatinib mesylate therapy.   "
184796|NCT00264173|"     Primary Objective :        -  To compare the efficacy of valproate to lithium in Bipolar I patients suffering from a          manic or a mixed episode according to DSM IV TR (APA 2000) [Diagnostic and Statistical          Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)] and over a          periode of 3 weeks and 12 weeks of treatment      Secondary Objective :        -  To evaluate the clinical and biological safety of valproate compared to lithium.   "
184797|NCT00264186|"     Inflammation is characterised by an increased risk for cardiovascular events. Dysfunction of     the vascular endothelium caused by oxidative stress might provide a mechanistic link. In     acute and chronic inflammation, oxidative stress occurs when the production of reactive     oxygen species [ROS] (including superoxide anions [O2-]) exceeds the capacity of the     endogenous antioxidant defense systems, resulting in ROS-mediated damage. Recombinant human     superoxide dismutase (rhSOD) has shown potent antioxidant properties in in-vitro and animal     studies and has been tested in phase I clinical trials in humans. rhSOD could offer a     therapeutic option for vascular dysfunction in diseases associated with increased oxidative     stress. The investigators, therefore, want to test if the hyporesponsiveness to vasoactive     drugs (norepinephrine, acetylcholine and glyceroltrinitrate) during acute inflammation by     low-dose lipopolysaccharide (LPS) is due to the increased production of superoxide anions,     which could be scavanged by the radical scavenger rhSOD.   "
184798|NCT00264199|"     The purpose of this study is to determine whether 48 hours of glucagon-like-peptide-1 (GLP-1)     infusion can improve heart function and alter substrate metabolism in non-diabetic patients     with heart failure.   "
184799|NCT00264212|"     To compare the antihypertensive efficacy and tolerability of irbesartan and     irbesartan-hydrochlorothiazide fixed combination therapy with amlodipine and amlodipine plus     hydrochlorothiazide in the treatment of isolated systolic hypertension.   "
184800|NCT00264225|"     This study aims to assess the analgesic effectiveness and safety of three different doses of     a new formulation of Lamaline® versus Dafalgan® Codeine after 10 days administration in     subjects with painful gonarthrosis   "
184801|NCT00264238|"     The purpose of this study is to determine whether memantine is safe and effective when used     as an augmentation to standard treatment for Obsessive-Compulsive Disorder (OCD).   "
184802|NCT00264251|"     The purpose of this study is to determine if, in men and women with excess abdominal fat and     insulin resistance, people with HIV infection respond differently than people without HIV to     interventions that typically improve body fat distribution and insulin resistance. The     specific interventions are:        1. Diet + exercise program.        2. Rosiglitazone treatment.        3. A combination treatment of diet + exercise program and rosiglitazone.   "
184803|NCT00264264|"     Hemostasis at the arterial puncture site after percutaneous coronary interventions is     achieved by either placement of a puncture closure device or by delaying sheath removal for     hours to allow normalization of heparin induced anticoagulation. Both of these methods are     far from ideal. Delayed sheath removal poses a risk of recurrent bleeding, hematoma formation     and results in decreased patient mobility while the safety of closure devices has been called     into question by several recent reports. Due to the lack of definitive data, the arterial     access site management varies considerably between physicians and among institutions. The     proposed study will evaluate the safety and efficacy of arterial closure devices to achieve     hemostasis compared with immediate sheath removal after protamine administration followed by     direct compression after percutaneous coronary intervention procedures.   "
184804|NCT00264277|"     The optimal duration of oral anticoagulant treatment in patients with idiopathic venous     thromboembolism is still uncertain. The present study addresses the possible role of the     D-dimer test in assessing the need for continuation of anticoagulation.The study aims at     assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in     these patients   "
184805|NCT00264290|"     The purpose of this study is to determine whether treatment with valganciclovir decreases T     cell activation levels among HIV-infected patients with asymptomatic cytomegalovirus (CMV)     co-infection, potentially improving immune responses to antiretroviral therapy.   "
184806|NCT00264303|"     A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in     patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus     severity score over the first week of treatment   "
184808|NCT00264329|"     To address the issues involved in treatment participation by substance-abusing parolees, the     CJ-DATS Transitional Case Management (TCM) study proposes to test a parole re-entry model     that consists of (1) completion by the inmate of a strengths and goals assessment as part of     discharge planning, (2) a telephone case conference call that includes the inmate and     significant members of the inmate's aftercare plan (including the parole officer), and (3)     strengths case management (for 12 weeks) in the community to promote treatment participation     and support the client's access to needed services.   "
184809|NCT00264342|"     This is a 2-year study involving the progressive reduction in the nicotine content of     cigarettes. The investigators believe that at the end of the study smokers of cigarettes with     progressively reduced nicotine content will be weaned from nicotine. At the end of the     study, the result will be a decreased level of nicotine dependence. When smokers are again     free to choose any smoking behavior, they will smoke fewer cigarettes and/or have a greater     interest in quitting compared to a control group that smokes their usual cigarettes.   "
184810|NCT00264355|"     Following heart transplantation many patients develop acute renal failure in the early     posttransplant phase and some are in need of renal replacement therapy for shorter or longer     time. The cause of this acute renal failure is most probably multi factorial but many reports     indicate that cyclosporine has a central role in the pathophysiology and it is generally     recommended to lower the cyclosporine load to patients developing acute renal failure in this     population.      Several in vitro studies on renal cells in culture indicate that the primary metabolites of     cyclosporine (AM1, AM9, AM4N) are less toxic to the kidney than cyclosporine itself. However,     the secondary metabolite AM19 as well as the cyclic metabolites AM1c and AM1c9 has been     associated with decreased renal function and nephrotoxicity renal transplant recipients.      The primary objective of this pilot study is to investigate if the concentrations of     secondary- and cyclic metabolites of cyclosporine (AM19, AM1c, AM1c9) is related to     development of acute renal failure in the early posttransplant phase following heart     transplantation.      Secondary objectives are to investigate associations between genotypes of P-glycoprotein and     CYP3A5 and the metabolic pattern of cyclosporine.   "
184811|NCT00264368|"     In order to optimize anti-cytomegalovirus (CMV) treatment with ganciclovir (GCV), in patients     with multi organ failure treated with continuous renal replacement therapy (RRT), more     information about ganciclovir pharmacokinetics in this setting is needed.      The primary objective is to describe the pharmacokinetics of ganciclovir in critically ill     patients with acute renal failure treated with continuous renal replacement therapy, with a     special emphasis on the extra-renal clearance and distribution volume.      Secondary objectives are to investigate if any co-factors, such as serum creatinine, weight,     general hydration status, rest function of the native kidneys, etc. can help to describe the     pharmacokinetics of GCV in these patients on continuous RRT as well as the relative influence     of filtrations and dialysis on GCV elimination during different modalities of the treatment.   "
184812|NCT00264381|"     The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium)     subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three     times daily for 7 days for the treatment of superficial thrombophlebitis (STP).   "
184813|NCT00264394|"     There is growing evidence that antiretroviral therapy (ART) increases the risk of coronary     heart disease (CHD) through metabolic side effects, such as dyslipidemia, insulin resistance,     and type II diabetes. Prevalence of risk factors for CHD in HIV-infected individuals     receiving ART in the Swiss HIV Cohort Study (SHCS) is high. This cluster randomised     controlled trial is nested into the SHCS and will investigate whether physicians randomised     to the routine provision of risk profiles from their patients receiving ART will improve the     management of risk factors in HIV-infected patients compared to control physicians not     routinely receiving such information. Risk profiles will be generated by the SHCS data center     and provided to clinicians in all study centers.   "
184814|NCT00264407|"     The purpose of this study was to determine the effects of hormone replacement therapy (HRT)     on hearing in post-menopausal women.   "
184815|NCT00264420|"     Zoledronic acid (Zometa) belongs to a class of drugs called bisphosphonates. Bisphosphonates     are used in bone metastases to keep the cancerous lesion under control in the bone and to     help prevent calcium level elevations in the blood. Cancer cell-culture studies at the     Cleveland Clinic showed that zoledronic acid and radiation together have more cell killing     effect than either one used alone. The purpose of this study is to monitor the healing of     bone lesions when using zoledronic acid together with radiation treatment.   "
184816|NCT00264433|"     N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer     progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study     will test the safety and effects of ADH-1 in subjects with specific incurable, solid tumors     with a protein biomarker called N-cadherin. This study will examine the clinical activity of     ADH-1.   "
184817|NCT00264446|"     5 fluorouracil (5 FU), one of the most actively investigated anti-cancer drugs, is rapidly     inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This     study will examine the kinetics of inhibition and recovery of the metabolic pathways for     fluoropyrimidines in subjects who receive a single oral dose of ADH300004, and may allow     optimization of oral 5 FU dosing to subjects in future studies.   "
184818|NCT00264459|"     The trial is performed to asses efficacy and safety of a sublingual extract of a six grass     pollen mixture   "
184819|NCT00264472|"     5 fluorouracil (5 FU), one of the most actively investigated anti-cancer drugs, is rapidly     inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This     study will test the safety and effects of oral ADH300004 14 hours prior to oral 5 FU in     subjects with refractory solid tumors.   "
184840|NCT00264745|"     The purpose of this study is to test a new educational program for families taking care of     persons who have had a stroke. Caregivers are asked what they think of the TASK program and     how to make it better. After getting the TASK program, their ability to provide care will be     compared with a group that did not receive the TASK program.   "
184966|NCT00267202|"     This study is designed to investigate the use of omalizumab as a pretreatment for patients     with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy     shots) and will test the hypothesis that omalizumab may reduce the rate of systemic reactions     to immunotherapy in patients with persistent allergic asthma.   "
184820|NCT00264485|"     The purpose of this study is to compare two pain medications delivered by two different forms     of patient-controlled analgesia (PCA) management systems: the Fentanyl HCl Patient-Controlled     Transdermal System (E-TRANS fentanyl) and the morphine intravenous pump. Fentanyl HCl and     morphine are narcotic pain relievers. The E-TRANS fentanyl system is a small unit worn on the     patient's upper outer arm or chest that uses low-intensity electrical current to deliver     fentanyl through the skin and into the patient's bloodstream. The patients studied will be     those who have just received a total hip replacement.   "
184821|NCT00264498|"     The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage     IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839     compared to gemcitabine/carboplatin.   "
184822|NCT00264511|"     Study hypothesis :Hyperbaric Oxygen may prevent complications and improve outcomes in severe     lower limb trauma. We propose to investigate this hypothesis by conducting an International     multi centre randomised control trial of standard trauma/orthopaedic care with or without a     concurrent course of hyperbaric oxygen treatments.   "
184823|NCT00264524|"     The current study was designed to determine whether the HLA-DRB1, DQA1, DQB1 alleles are     associated with the risk and the pattern of valve damage of RHD.   "
184824|NCT00264537|"     The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in     combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis     subjects who have not been previously treated with methotrexate.   "
184825|NCT00264550|"     The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in     combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid     arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.   "
184826|NCT00264563|"     Iatrogenesis is inevitable in the NICUs.   "
184827|NCT00264576|"     The purpose of this study is to evaluate the safety and immunogenicity of cell     culture-derived, inactivated, subunit influenza vaccine in comparison to licensed Fluvirin     vaccine administered to healthy adults ages 18 < 50 years.   "
184828|NCT00264589|"     Obesity and diabetes increase cardiovascular risk by complex and incompletely known     mechanisms. The aims of this study are :        1. to compare cardiac and vascular functions at rest and during exercise in 4 groups of          age-matched men, without cardiovascular diseases but exhibiting increasing          cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic          subjects        2. to test the effects of a 8-weeks long individualized training program on these functions          in obese subjects and in diabetics patients.   "
184829|NCT00264602|"     The primary purpose of this study is to determine if we can identify the first lymph node     that drains from the tumor, and thus would be the most likely site for metastatic disease,     and remove it for analysis to improve the ability to detect tumor in this node and to remove     this additional site that potentially contains tumor cells.   "
184830|NCT00264615|"     Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy     patients when switching from LAMICTAL immediate-release to extended-release and vice versa.   "
184831|NCT00264628|"     The purpose of the study is to investigate safety, tolerability and efficacy of oral GW679769     up to 120 mg dose compared to placebo in patients with ACR(American College of     Rheumatology)-defined fibromyalgia, co-morbid with depression.   "
184832|NCT00264641|"     The purpose of this study is to evaluate the cerebral blood flow in subjects with high and     low activity in the renin-angiotensin system (RAS).The renin-angiotensin system is a hormone     system which is involved in the regulation of the blood pressure. Earlier studies have shown     that high RAS activity is associated with a more pronounced cognitive impairment during     hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy     volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning     during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers     with high and low RAS activity, respectively   "
184833|NCT00264654|"     This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)   "
184834|NCT00264667|"     Study in patients with dyslipidaemia.   "
184835|NCT00264680|"     Validation of qolie-10, an epilepsy specific quality of life questionnaire in patients     treated with lamotrigine or valproic acid. Comparison of quality of life of epileptic     patients treated with lamotrigine or valproic acid. Determination and assessment of the     comparative safety of lamotrigine or valproic acid. Assessment and comparison of body image     perception in women treated with lamotrigine or valproic acid.   "
184836|NCT00264693|"     Low molecular weight heparins (LMWH) have been shown to be at least as efficient and safe as     unfractioned heparin (UFH) in prophylaxis and treatment of venous thromboembolic events and     in therapy of acute cardiovascular diseases. LMWH are widely used as safe replacement of oral     anticoagulation with vitamin K antagonists (VKA).      Due to their pharmacokinetic characteristics, LMWH tend to accumulate in patients with     impaired renal function. Official guidelines recommend therefore to use LMWH controlled by     Anti-Xa levels or to use UFH instead of LMWH to provide full therapeutic anticoagulation     therapy in patients with severe renal insufficiency.      Although dosage recommendations have been proposed for enoxaparin in patients with renal     impairment based on several studies, these data cannot be applied to other LMWH directly due     to different pharmacokinetic properties of each drug.      The present study aims to clarify the pharmacokinetics of dalteparin in patients with renal     insufficiency, especially addressing the question of accumulation after multiple doses and     including patients with severe renal insufficiency and derive a safe and suitable concept for     using dalteparin in patients with impaired renal function.   "
184837|NCT00264706|"     The primary objectives of this trial are: 1) to evaluate the safety of NONA-L-ARGININE in ex     vivo application to saphenous vein segments prior to grafting; and, 2) to obtain preliminary     data on the biological effects of NONA-L-ARGININE, as compared to placebo, in the prevention     of neointimal hyperplasia.   "
184838|NCT00264719|"     Hypothesis: Early use of oral metoclopramide can hasten and improve the establishment of     lactogenesis II in mothers after preterm and term deliveries.      The study hopes to show that metoclopramide can be effective to establish and sustain     Lactogenesis II for both preterm and term infants.   "
184841|NCT00264758|"     The Frequent Hemodialysis Network (FHN) Daily Trial is a randomized controlled trial     recruiting subjects from dialysis units associated with designated Clinical Centers in the     U.S. and Canada and followed for 1 year. Subjects will be randomized to either conventional     hemodialysis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per     week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The     study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months     in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with     the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life     scale.   "
184842|NCT00264771|"     The purpose of this ongoing study (Part II) is to estimate the incidence of acute rheumatic     fever, rheumatic heart disease, acute post-streptococcal glomerulonephritis (kidney disease),     and invasive group A streptococcal (GAS) disease (strep infection) in Fiji to help develop     better treatments and vaccines. Group A streptococcal disease is caused by the bacterium     group A streptococcus. It is commonly found in the nose and throat of normal healthy adults     and children, and can cause illness. The bacterium is spread by close contact with patients     or carriers, through things like coughing, sneezing, kissing, or sharing a drink and can     cause a wide variety of illnesses. These illnesses may be a sore throat, skin sores, and less     commonly acute rheumatic fever or kidney disease. Participants of all ages will be recruited     through the Colonial War Memorial and Lautoka Hospital. A blood sample will be collected from     each study participant. Subject participation should be less than one day.   "
184843|NCT00264784|"     The purpose of this ongoing study (Part V) is to evaluate the cause, distribution, control,     and results of group A streptococcus infections (GAS) in Fiji. Patients of all ages     presenting to the Colonial War Memorial Hospital, Suva, Fiji and patients donating blood to     the Colonial War Memorial Hospital, Suva, Fiji may participate. Subject duration is less than     one day. This study may help to develop a vaccine that will prevent group A streptococcal     infections.   "
184844|NCT00264797|"     The purpose of this study is to determine the efficacy of osmotic-release methylphenidate     (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.   "
184845|NCT00264810|"     The RNS® System Pivotal study is designed to assess safety and demonstrate that the RNS®     System is effective as an adjunctive (add-on) therapy in reducing the frequency of seizures     in individuals 18 years of age or older with partial onset seizures from no more than two     foci (two areas of the brain) that are refractory (drug-resistant or hard-to-treat) to two or     more antiepileptic medications. Patients continue to receive their epilepsy medications while     participating in the study.   "
184846|NCT00264823|"     The purpose of this research study is to investigate how nurses can best help people with     serious mental illnesses (SMI) follow their HIV treatment plans.   "
184847|NCT00264849|"     Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with     severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to     omalizumab over time will be assessed by physicians and patients evaluating the overall     improvement in control of their asthma.      THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.   "
184848|NCT00264862|"     The aim of this study is to evaluate a new way to create CT-like images during     intra-operative procedures. We want to prove that the quality and information received from     DynaCT is satisfactory in implementing stent-graft in abdominal aortic aneurysm.   "
184849|NCT00264875|"     To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated     with HIV neuropathy   "
184850|NCT00264888|"     In some patients with Duchenne muscular dystrophy (DMD), the disease is caused by a nonsense     mutation (premature stop codon) in the gene that makes the dystrophin protein. PTC124 has     been shown to partially restore dystrophin production in animals with DMD due to a nonsense     mutation. The main purpose of this study is to understand whether PTC124 can safely increase     functional dystrophin protein in the muscles of patients with DMD due to a nonsense mutation.   "
184851|NCT00264901|"     This trial is conducted in the United States of America (USA). This trial aims for a     comparison of the safety and efficacy in subjects with type 2 diabetes using either self     titration or physician guided titration according to the local standard of care.   "
184852|NCT00264914|"     To determine the long-term safety and tolerability of SR121463B in patients with syndrome of     inappropriate antidiuretic secretion (SIADH). To assess the long-term efficacy of SR121463B     in maintaining normal levels of serum sodium in patients with SIADH.      Long term safety is evaluated further in an open label extension study with flexible doses of     satavaptan.   "
184853|NCT00264927|"     To assess the efficacy of SR121463B in correcting hyponatremia in patients with syndrome of     inappropriate antidiuretic secretion (SIADH).To assess the long-term efficacy of SR121463B in     maintaining normal levels of serum sodium in patients with SIADH. To assess the safety and     tolerability of SR121463B in patients with SIADH.      The double blind period is followed by an open label extension study with flexible doses of     satavaptan.   "
184872|NCT00265174|"     Numerous studies document the ability of tumors to shed DNA into the blood stream.     Circulating DNA can thus be recovered for analyses, representing a surrogate tumor material     to test for potential applications in disease diagnosis and prognosis.      Detection of genetic alternation is one of the most important tests for cancer patient since     they offen correlated with the clinical course, prognosis and chemosensitivity of primary     brain tumors. Currently in brain tumor patients these molecular aberrations can be analyzed     only on tumor tissue that was obtained at surgery or biopsy.      Paucity of pathologic samples or poor fixation technique often make the tissue samples     unassessable for molecular aberrations.      Therefore, the ability to extract tumor DNA from peripheral blood holds a great clinical     significance. Still, the molecular aberration evaluated on serum DNA should be correlated and     verified by comparison to standard evaluations performed on tumor samples. Our study aim is     to evaluate the feasibility of using serum DNA for routine diagnosis of tumor molecular     aberrations.   "
184873|NCT00265187|"     Sputum specimens will be obtained from children < 2 years of age and processed by different     mode for the HMPV, RSV, Pertussis, Influenza A, B, Parainfluenza 1,2,3, Adenovirus. Clinical     and epidemiological data will also be obtained.   "
184874|NCT00265200|"     The purpose of this study is to evaluate a new blood test as a way to follow the effect of     Zometa in treating bone metastases due to lung cancer.   "
184854|NCT00264940|"     The prevalence of type 2 diabetes is rising in the population for many years. It is now     recognized that a period of glucose intolerance precedes the clinical symptoms appearance.     This is due to a combination of b-cell dysfunction and insulin resistance. It is estimated     that this pre-clinical phase of type 2diabetes may antedate the onset of overt diabetes by     10-12 years. Furthermore, insulin resistance is considered to be a main component of the     metabolic syndrome and associated with significant cardiovascular morbidity and mortality.     Recently, there has been an effort to pinpoint the pre-diabetic phase for early therapeutic     intervention in the individual. These studies, in patients with impaired glucose intolerance,     have shown to be beneficial from both lifestyle change and pharmacological intervention. It     is thus hypnotized that intervention in patients with insulin resistance with or without     glucose intolerance may prevent the progress of type 2 diabetes and it’s complications. There     is difficulty in identifying individuals who are at high risk for type 2 diabetes. The     prevention strategy relies on intervention in a pre-diseased state. In the case of type 2     diabetes, the early intervention is useful in the phase where there is insulin resistance,     but prior to the appearance of glucose intolerance. The diagnosis of insulin resistance is a     challenging one. The gold standard in diagnosing insulin resistance is the     hyperinsulinemic-euglycemic clamp, but this method is not suitable for routine clinical use.     Thus, less invasive methods for evaluation, like homeostasis model assessment (HOMA) and     quantitative insulin sensitivity check index (QUICKI), were developed. There is a correlation     between HOMA and QUICKI results and the hyperinsulinemic-euglycemic clamp. Both HOMA and     QUICKI allow insulin resistance diagnosis. The results from those tests correlate with     hyperinsulinemic-euglycemic clamp and allow diagnosing insulin resistance, however, those     indexes require serum glucose, insulin measurements and quite complicated calculations. A new     method was suggested, non-invasive, sensitive and simple, for the identification of insulin     resistance. In normal individuals, in the presence of insulin, glucose is taken up by a     variety of cells, undergoes glycolysis and enters the tricarboxylic acid cycle or fat     synthesis. In either case, CO2 in produced as a by-product. This CO2 enters the circulation     and is discarded by the lungs. The new method is based on the assumption that 13C-glucose is     ingested as described and its by-product 13CO2 can be measured in the expired air. In type 2     diabetes and other states of insulin resistance glucose, uptake is impaired and results in     blunted 13CO2 production. This hypothesis was tested by Lewanczuc et al. The writers compared     the [13C]-glucose breath test with hyperinsulinemic-euglycemic clamp, HOMA and QUICKI     indexes. They tested 26 patients at different stages of insulin sensitivity and reported a     good correlation of the glucose breath test and the other indexes. We suggest testing a     larger group of patients at high-risk to develop type 2 diabetes and compare the glucose     breath test with HOMA index.   "
184855|NCT00264953|"     This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD     as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the     optimum radiation dose comparing of 30 to 20 Gy in the same context.   "
184856|NCT00264966|"     To determine the safety and efficacy of multiple doses of ASM8 antisense oligonucleotides in     asthmatics.   "
184857|NCT00264979|"     The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has     not still been defined. The purpose of this study is to compare two treatment strategies in     which liver resection is performed either during, or 12 to 14 weeks after the primary     resection. Endpoints include the rate of severe complications and survival.   "
184858|NCT00264992|"     Implantation failure of the embryo might be the result from the environment in the uterus.     Proteins (cytokines) are screted by the endometrium which can result in a pro or anti     inflammatory environment. The aim of this study is to identify pre-implantation endometrial     and embryo cytokine expression profiles associated with successful and unsuccessful embryo     implantation in assisted reproduction cycles.   "
184859|NCT00265005|"     The purpose of this study is to determine if alteplase is effective in dissolving a clot in a     catheter in a large vein (central venous line or PICC line) or artery in infants less than 6     months of age.   "
184860|NCT00265018|"     This study is designed to find the optimum radiation dose and number of cycles for an ABVD     chemotherapy combined with an involved field irradiation. It is to be tested whether the     reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20     Gy is feasible without a loss of efficacy.   "
184861|NCT00265031|"     This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in     the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is     necessary following effective chemotherapy.   "
184862|NCT00265044|"     To improve the quality of hypertension care in our facility, while concurrently, examining     the relative contribution of each aspect of a multi-factorial intervention designed to     improve hypertension care.   "
184863|NCT00265057|"     N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer     progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study     will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a     protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that     subjects can tolerate.   "
184864|NCT00265070|"     This study is being carried out to see if ZD1839 is effective in treating prostate cancer     after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.   "
184865|NCT00265083|"     The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections     (under the skin) of golimumab for the treatment of active ankylosing spondylitis     [AS(arthritis of the spine)]. Efficacy will be measured by reduction in the signs and     symptoms of active AS, including effects on back pain and stiffness, physical function, range     of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.   "
184866|NCT00265096|"     The purpose of this study is to evaluate the safety and efficacy (improvement of signs and     symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of     active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and     symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray     related to joint damage, psoriasis skin lesions, physical function, and quality of life.   "
184867|NCT00265109|"     The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for     people with body dysmorphic disorder.   "
184868|NCT00265122|"     The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants     with active Crohn's Disease.   "
184869|NCT00265135|"     The purpose of this study is to better understand the safety, tolerability and distribution     of CNTO 328 in the bloodstream.   "
184870|NCT00265148|"     This is a placebo-controlled study evaluating the effects of rosiglitazone on functional     brain activity and cognition in patients with mild to moderate Alzheimer's Disease (AD).   "
184871|NCT00265161|"     The study will be held in the winter of 2005-2007. The aim is to assess the effectiveness of     the influenza vaccine in health care workers (HCW).   "
184875|NCT00265213|"     we revise 8 disability items from SPADI into Chinese to develop a simple self-completion     questionnaire for the assessment of restriction in daily activities resulting from breast     conservative surgery.      The purpose of this study was to validate the score obtained from this questionnaire by     testing restriction of shoulder active flexion and abduction on examination at post BCS 2     days correlates with disability score.   "
184876|NCT00265226|"     The purpose of the study is to study the efficacy and safety of Mycobacterium in treating     patients with lung tuberculosis . Mycobacterium is a strain of bacterium which is used as a     vaccine and an adjuvant drug against leprosy. This agent has also been found to be effective     in the treatment of lung tuberculosis in a limited number of patients.      The researchers are conducting this study in the World Health Organization (WHO) category-II     of lung tuberculosis patients to see the efficacy and also to see any change in immunological     parameters.   "
184877|NCT00265239|"     Early reperfusion therapy has improved the clinical outcomes of patients with acute     myocardial infarction (AMI), but these benefits are limited in some patients by reperfusion     injuries. There is now increasing evidence that reactive oxygen species cause reperfusion     injury. This study was designed to examine the effects of edaravone, a novel free radical     scavenger, in patients with AMI.   "
184878|NCT00256633|"     TITLE: CSP 465-C, Fatty Acid Binding protein 2 (FABP2) ancillary proposal to CSP# 465     Glycemic Control and Complications in Diabetes Mellitus Type 2.      Angeliki Georgopoulos, M.D. Carlos Abraira M.D. William Duckworth M.D.      Fatty acid binding protein 2 (FABP2) is involved in the transport of long chain fatty acids     across the intestinal epithelium. A common (40-45%) polymorphism of FABP2 gene (codon 54     Threonine for Alanine) results in increased intestinal fatty acid absorption and triglyceride     secretion (Baier et al J Clin Invest 95:1281-87, 1995; Baier et al J Biol Chem 271:     10892-10896,1996). We have found (JCEM 85:3155-60, 2000) that in patients with type 2     diabetes, the codon 54 polymorphism of the FABP2 results in fasting and postprandial     hypertriglyceridemia. Since hypertriglyceridemia is a risk factor for atherosclerosis in type     2 diabetes and it is part of the insulin resistance syndrome, the objective of this ancillary     study would be to screen the participants of the CSP# 465 study for the polymorphism and     assess a) whether those carrying the polymorphism respond differently to the various     treatment modalities and b) whether they develop more cardiovascular events compared to the     ones lacking the polymorphism. There is one study that suggests an association of the     polymorphism with a history of parental stroke (JCEM 85:2801-4, 2000).      The only additional request from the study participants will be to agree to the collection of     a blood sample to be used for DNA isolation and screening for the polymorphism. No additional     funds are requested. If this polymorphism proves to be a predictor of either the response to     a specific treatment modality or of the risk to macro-vascular complications, it will be very     easy to screen for it and target our treatment modalities appropriately.   "
184879|NCT00256646|"     OBJECTIVES: Vascular Disease is the leading cause of complications and death in patients with     diabetes. Risk markers and underlying mechanisms have not been fully elucidated, and may     differ from those in non-diabetic individuals. The unifying theme for the Program Project is     that hyperglycemia and insulin resistance alter a number of biological processes which     interact in vicious cycles to accelerate atherogenesis and are consequently major underlying     risk factors for vascular disease. The overall objectives are to define these unique     processes and to elucidate underlying biochemical, metabolic, and genetic determinants of     vascular disease complications in diabetes.      RESEARCH PLAN: Over the past 4 years, we have collaborated with the DCCT/EDIC Study Group,     and have made novel observations regarding vascular disease pathogenesis in Type 1 Diabetes.     This work has focused our studies on specific pathogenic processes. We will now study a Type     2 Diabetes cohort from the VA Cooperative Study, Glycemic Control and the Complications of     Diabetes, Type 2, with high vascular disease event rates. These collaborations provide a     unique opportunity to address the pathogenesis of accelerated atherogenesis in the two main     types of diabetes, and will greatly augment the scientific knowledge that will be gained in     the conduct of these world-class prospective trials.      METHODS: The Program Project has 4 projects and 3 cores. Project 1 will assess lipoproteins,     glycoxidative stress, and inflammation as risk factors in studies involving Type 2 Diabetes     patients and cultured cell systems. Based on preliminary data from our initial studies Type 1     patients, changes in the NMR lipoprotein subclass profile will be emphasized.      Project 2 will elucidate interactions between inflammation, modifications of lipoproteins,     and autoimmunity in vascular disease risk. These novel concepts are also based upon exciting     preliminary data pertaining to LDL-antibody complexes.      Project 3 will pursue interesting preliminary data and define the role of the     kallikrein-kinin system in vascular disease complications, with effects on mitogenesis and     matrix production.      Project 4 will assess the role of the Insulin Resistance Syndrome and novel factors secreted     from adipocytes in the pathophysiology of biochemical risk factors and cardiovascular     complications.      Cores include an Administrative Core, a Biostatistics and Epidemiology Core which will link     with the trials data coordinating centers, and Molecular and Statistical Genetics Core.     Investigators will work in close collaboration with the VA Executive Committee, Study     Centers, the Hines Coordinating Center, and some of the other ancillary studies. All data     analysis involving clinical outcomes will be performed at the Hines Coordinating Center.      There is true synergism among the projects at both scientific and logistical levels. The     Program Project design allows for interactions among multidisciplinary investigators studying     the same cohort, which will define how multiple pathological processes interact at the level     of the arterial wall to promote atherosclerosis.   "
184880|NCT00256659|"     To evaluate the utility of real time prognostic data (illness severity, stability and     function) in the improvement of hospitalization morbidity, mortality, iatrogenic     complications and length of stay.   "
184881|NCT00256672|"     The purpose of this study is to determine whether full-time high dose prophylactic bracing     (23 hours or more per day) is more effective than low dose bracing (12 hours or less per day)     in preventing or delaying spinal curve progression in children with scoliosis after spinal     cord injury.   "
184882|NCT00256685|"     The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate     (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with     menopause, and also to assess the effects of DVS on sleep parameters and health outcomes     indicators.   "
184883|NCT00256698|"     The purpose of this study is to determine the efficacy of anastrozole monotherapy versus     maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared     with in treatment of hormone receptor positive women with first relapse of breast cancer.   "
184884|NCT00256711|"     This is a randomized, open label, parallel group, multi-centre, phase II study of progression     free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30     mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with     locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.   "
184885|NCT00256724|"     The purpose of this study is to determine if the impedance threshold device (ITD) attached to     a facemask can increase blood pressure in patients who present to the emergency department     with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss,     sepsis, or dehydration.   "
184886|NCT00256737|"     The purpose of this study is to study gastritis, GI symptoms during long term omeprazole     treatment   "
184887|NCT00256750|"     The purpose of this study is to learn if Belatacept can provide protection from organ     rejection following kidney transplantation while avoiding some of the toxic effects of     standard immunosuppressive medications such as kidney damage. Effects on kidney function and     patient survival as well as drug safety will also be studied.   "
184888|NCT00256776|"     This is an international study in adult patients diagnosed with multiple myeloma who have     already received at least one autologous stem cell transplantation and who have responded but     later progressed, or relapsed, at least one year after transplantation.      Eligible patients will be randomly assigned to one of two treatments: either Velcade plus     Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone.      Thalidomide and Velcade are two new agents that have recently become available for the     treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to     test the hypothesis that the combination treatment with Velcade plus Thalidomide plus     Dexamethasone will result in a longer time to progression (measure of time after the disease     is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.   "
184897|NCT00256893|"     A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in     particular the widespread pain associated with this condition. A total 160 subjects (80 per     treatment arm) are being recruited from approximately 25 centres in 9 European countries.     Male and female subjects greater than 18 years of age with a diagnosis of primary     fibromyalgia, as defined by the American College of Rheumatology (ACR) criteria, are eligible     for study entry. Subjects will receive either ropinirole (1-24mg) or placebo, depending upon     a statistically defined allocation to treatment. The primary endpoint is improvement in pain     score by 12 weeks of treatment. An 11 point numerical rating scale for the assessment of the     subject's pain is being collected on a daily diary. In addition, the overall improvement in     quality of life for the subject will be assessed by means of a number of subject-completed     questionnaires during the treatment period. Safety of the treatment regimen will be assessed     throughout the study.   "
184889|NCT00256789|"     This program is designed for the treatment of patients with advanced non-small cell lung     cancer. The study is designed for patients whose cancer is too advanced and therefore cannot     be operated with the goal of completely removing the cancer. Patients at this stage of their     disease traditionally receive radiation therapy or chemotherapy or both treatments in     succession. Recently, the administration of both methods of treatment has been employed and     preliminary studies indicate somewhat better results. Specifically, a new class of     chemotherapy agents called taxanes used in combination with radiation therapy appear     promising as determined in small studies. However, the best treatment for this type of cancer     has not been established yet. One goal of this study is to investigate if the combination of     the new drug Taxotere (a drug belonging to the taxane class) given on the day of the     radiation is well tolerated and will result in enhanced shrinkage of the cancer compared to     traditional radiation therapy. In this study the radiation will be given on one day, rather     than divided over five days per week (Monday through Friday) as in previous studies. Previous     research has shown that both equal in how effective they are in treating lung cancer. The     study will use the drug Taxotere in conjunction with radiation therapy. Taxotere is an     approved medicine by the United States Food and Drug Administration for the treatment of lung     cancer.      The purpose of this study is to evaluate if the chemotherapy drug Taxotere administered once     weekly together with concurrent radiation on the same day is effective in shrinking non-small     cell lung cancer. This trial will also investigate how well this treatment is tolerated and     what effects this treatment will have on the everyday life and activities of participants.   "
184890|NCT00256802|"     To examine the ability of MRA to measure the effect of GTN on the intra-cranial vascular     response during the GTN-induced headache in healthy volunteers.   "
184891|NCT00256815|"     The study is designed for subjects whose cancer is too advanced and therefore cannot be     operated with the goal of completely removing the cancer. At this stage of the disease, most     subjects cannot be cured from the disease, however, treatment can help subjects to live     longer and better by keeping the cancer under control. All treatment offered to is primarily     pursuing that goal. Subjects at this stage of their disease traditionally receive radiation     therapy or chemotherapy, both treatments in succession or both concurrently. Recently, the     administration of both methods of treatment concurrently has been employed and indicate     somewhat better results. Specifically, a class of chemotherapy agents called Vinca Alakaloids     used in combination with radiation therapy appear promising as determined in small studies.     The drug Navelbine is part of this class of drugs. This drug is approved as an infusion     through the veins. The pill form is under development and will be used in this form in this     treatment program.      For this protocol, radiation will be administered using a schedule which is more convenient     for patients, by once weekly chest irradiation for a total of 12 weeks. Use of this schedule     was determined to be as good as the more commonly used daily radiotherapy. The once weekly     schedule is less cumbersome as it involves less visits. The rationale and reason why you are     being asked to participate in this program is to study whether the drug Navelbine can be     given together with the once weekly radiation schedule. Radiation will be administered in two     fractions, 6 hours apart on one day. For this program, the drug Navelbine would be made     available as a pill, and would not have to be infused through the vein. The proposed protocol     will use increasing doses of the drug Navelbine in pill form to find the highest dose of     Navelbine that is tolerated in conjunction with radiation therapy. Initially, each subject     will receive one dose of Navelbine, which is higher than the dose of the previous subject.     This escalation will continue until the highest tolerated dose has been determined.      The administration via pill would be easier and avoid previously experienced side effects     that were experienced by infusion into the veins of subjects, such as burning and sores at     the infusion site.   "
184892|NCT00256828|"     The purpose of this study is to compare the antiviral activity of two treatment groups for     HIV chronic infection: a QD regimen of didanosine, lamivudine and efavirenz versus a BID     regimen of zidovudine, lamivudine and efavirenz. Both will be administered with food in the     starting treatment of human immunodeficiency virus infection at Week 48.   "
184893|NCT00256841|"     The study is designed for patients with non small cell lung cancer whose cancer is too     advanced and therefore cannot be operated with the goal of completely removing the cancer. At     this stage of the disease, most patients cannot be cured from the disease, however, treatment     can help to live longer and better by keeping the cancer under control. For that purpose,     patients traditionally receive radiation therapy or chemotherapy or both treatments in     succession. Recently, the administration of both treatment methods given concurrently showed     somewhat better results when compared to successive administration. In some studies the drug     Taxotere together with radiation performed well in keeping the cancer better under control.      Combination of the drug Taxotere together with a compound called 5-FU either as continuous     infusion or in its oral form of a pill called Xeloda enhanced its anti cancer activity     substantially.      One goal of this study is to investigate how much of the combination can be given in     conjunction with chest radiation. Using X-rays, the study will also evaluate how much     shrinkage of the cancer is caused by this treatment directly at the tumor site and other     areas where the cancer may have also spread.      In this study the radiation will be given on only one day per week in two sessions, rather     than divided over five days per week (Monday through Friday) as it is more commonly used.     However, both schedules have been found to be equally effective.      The treatment program will use increasing doses of the 5-FU medication, either as infusion or     as pill to find the highest dose that is tolerated. Once the highest tolerated dose is     determined, subsequent patients who will be enrolled will continue to be treated at that dose     level. The dose of the drug Taxotere will remain the same throughout.      Hypothesis: Our previous research suggests that the combination of Taxotere and 5-FU given     together with weekly chest radiation will provide a more convenient form of treatment than     the conventional approach and also be at least similar in its efficacy.   "
184894|NCT00256854|"     This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed     dose conversion recommendations for RLS subjects converting from ropinirole immediate release     to ropinirole controlled-release for RLS.   "
184895|NCT00256867|"     This study evaluates the effect of medicines for type 2 diabetes and lipids control. This     study will require about 6 office visits for lab tests and examinations. All study related     medicines and medical examinations will be provided at no cost to the subjects.   "
184896|NCT00256880|"     The purpose of this study is to determine how effective and safe a new investigational drug     is in treating patients with relapsed or refractory multiple myeloma. The treatment involves     daily dosing. A patient may continue to receive the treatment as long as they are benefiting     from the treatment. Blood samples will be taken at specific times to measure the amount of     drug in your body at specific times after the drug is given. Blood samples will also be taken     for lab tests such as complete blood counts and clinical chemistries. Physical exams will be     performed before each treatment. During the treatment phase, the patients will undergo     regular assessments for safety and clinical response.   "
184898|NCT00256906|"     Isolated mild fetal ventriculomegaly is a common finding in fetal ultrasound examinations.      When the ventricular diameter is more than 15 mm it is usually considered as severe and     connected to other malformations. Most of these children will be severely affected later in     life. Less than 10 mm ventricular width considered as normal.      The current medical knowledge can not answer questions regarding future development of     children who were diagnosed to suffer from mild (10-14.9 mm) brain ventriculomegaly during     the pregnancy.      We would like to assess the development and neurological status of all children who were     diagnosed as mild ventriculomegaly during the pregnancy in the last 6 years and to     prospectively follow up all the children who will be diagnosed from the beginning of the     study on for 6 years.      We hypothesized that the course of their development is different than of other children.   "
184900|NCT00256932|"     Adults who are taking opioid therapy for persistent non-cancer pain and have resulting     opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or     to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan     with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on     frequency of bowel movements. Subjects will be required to: (1) track their bowel movements     and other bowel symptoms and (2) attend 6 clinic visits over 4 months.   "
184901|NCT00256945|"     In this study we intend to find out the pattern of biofilm accumulation in vivo on various     surface finishings.      Our intention is to prepare Polymethylmetacrylate squers on orthodontical brackets,then     prepare the surface of the sample and measure the surface roughness with a profilimeter and     get the mean value in Ra units, then place the brackets on lower premolars and molars for 12     hours, remove them and examine the biofilm formed with confocal scanning microscope.   "
184902|NCT00256958|"     Knee osteoarthritis (OA) is one of the most prevalent musculoskeletal complaints worldwide,     affecting 30-40% of the population by the age of 65 yr.Individuals with knee OA suffer     progressive loss of function.Balance is an integral component of these and many other     activities of daily living. Individuals with knee OA display impairment in postural control,     mostly under dynamic testing condition. Total knee replacement (TKR) has an established place     in the treatment of knee osteoarthritis and is considered to be an effective intervention.It     remains unknown whether TKR impact significantly at balance state of the patients with OA and     whether improving in functional abilities after TKR correlates with balance control ability     in this population.The purpose of this study is to determine whether TKR have any effects on     relatively new postural control measures using force platform system - Balance master, in     correlation with functional balance assessment.      Methods:      Participants During a year of prospective study we plan to recruit 150 participants with     symptomatic OA of the knee, hospitalizing in orthopedic department of Hadassah Hospital for     primary TKR. Participants will undergo evaluation just before a surgery and a year after.They     will be asked to perform Balance Master measurements, ambulation and balance tests.     Additional information will be collected through a questionnaire and physical examination.   "
184903|NCT00256971|"     The important role of the menisci in knee function and in preserving knee health has been     shown in several studies. Additionally to principal functions of load transmission and shock     absorption, meniscus contributes to knee joint proprioception and probably also to joint     stability.Study about affect of meniscus injury on balance posture has not previously been     published.Surgical practice is increasingly aimed at minimal resection of injured tissue,     preserving a stable meniscal remnant with as much function as possible.The purpose of this     study is to determine whether menisci surgery have any effects on relatively new postural     control measures, in correlation with functional balance assessment. The second purpose is to     establish the affect of different types of menisci surgery on balance impairment     (meniscectomy vs tear repair), in correlation with a long-term outcome.   "
184904|NCT00256984|"     The primary purpose of this study is to determine how effective and how durable STARR     (stapled transanal rectal resection) surgery is in relieving symptoms of intractable     constipation associated with obstructive defecation syndrome (ODS).   "
184905|NCT00256997|"     The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic     medication) versus oral antipsychotics in schizophrenia (psychiatric disorder with symptoms     of emotional instability, detachment from reality, often with delusions and hallucinations,     and withdrawal into the self) participants with a history of being poorly compliant with     taking their medication.   "
184906|NCT00257010|"     The purpose of this study is to evaluate the long-term safety of almotriptan malate (a     migraine headache medication) in the treatment of migraine headaches in adolescents for up to     one year.   "
184907|NCT00257023|"     The purpose of this study is to assess the safety, effectiveness, and plasma concentration of     paliperidone (an antipsychotic medication) given once daily in the treatment of patients with     schizophrenia   "
184908|NCT00257036|"     The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an     antibiotic, compared with ciprofloxacin, another antibiotic, in the treatment of adults with     mild to moderate infections of the skin and the supportive layers beneath the skin.   "
184909|NCT00257049|"     The purpose of this study is evaluation of the safety and effectiveness of levofloxacin, an     antibiotic, compared with ceftriaxone sodium or cefuroxime axetil in the treatment of adults     with pneumonia.   "
184910|NCT00257062|"     The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an     antibiotic, compared with another antibiotic, ciprofloxacin, in the treatment of adults with     uncomplicated infections of the skin and the supportive layers beneath the skin.   "
184911|NCT00257075|"     The purpose of the study is to assess the effectiveness and safety of risperidone (an     antipsychotic medication) versus placebo during 3 weeks of treatment of mania in patients     with Bipolar I Disorder who are suffering a manic episode.   "
184912|NCT00257088|"     This five-year prevention services application is concerned with preventing substance abuse,     comorbid mental and behavioral disorders, and school failure. We will direct an integrated     set of first grade classroom based preventive interventions at two correlated and confirmed     early antecedents: early aggressive, disruptive behavior and poor achievement. We will test a     comprehensive Whole Day (WD) program directed at improving: 1) teacher's classroom behavior     management; 2) family/classroom partnerships regarding homework and discipline; and 3)     teacher's instructional practices regarding academic subjects, particularly reading. We will     test WD effectiveness in a developmental epidemiological design in which children and     teachers are randomly assigned to intervention and standard setting (control) classrooms in 2     classrooms in each of 12 schools. While following the first grade children to the end of     third grade, we will follow their first grade teachers over two subsequent cohorts of first     graders to test whether the support and training structure sustains high levels of WD     practice. We will also test whether the support and training structure is successful in     training non-WD teachers. This prevention services aim will be augmented by an economic     analysis of the costs and cost-effectiveness of the WD program. This combined services and     prevention research should increase the efficiency of developing evidence-based programs and     extending their use system-wide in both the prevention and education fields. The aims of our     proposed work are to: 1) Implement and evaluate the effectiveness of a whole-day preventive     intervention program for first-grade (WD) directed at known antecedent risk factors for later     substance abuse, school failure, and comorbid mental and behavioral disorders; 2) Measure the     variation in impact of WD due to variation in the experimentally manipulated quality of     teachers' specific WD practices around classroom behavior management, family/classroom     partnership, and quality of instruction, regarding reading, taking into account family, peer,     and community factors; 3) Test effective- ness of the support structure required to sustain,     and extend to other teachers high quality implementa- tion of WD; 4) Carry out economic     analyses of the costs of implementing WD and their cost-effectiveness.   "
185475|NCT00273871|"     The purpose of the study is to determine the effect of conversion from calcineurin inhibitor     based therapy to Rapamune based therapy in patients with mild to moderate renal     insufficiency.   "
184917|NCT00257153|"     In patients with acute ST-segment elevation myocardial infarction (STEMI), percutaneous     coronary intervention (PCI) may cause thrombus dislodgment and impaired microcirculatory     reperfusion. This study was designed to test the hypothesis that thrombus aspiration before     standard PCI may improve acute myocardial reperfusion, measured by ST-segment resolution     (STR) and myocardial blush grade (MBG), compared with standard PCI.   "
184918|NCT00257166|"     The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective     for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or     mixed).   "
184919|NCT00257179|"     This study uses serum tissue factor and tissue factor inhibitor and factor VII to monitor the     pre-coagulation status in lung cancer patients and to correlate the pre-coagulation status     with clinical staging and prognosis.   "
184920|NCT00257192|"     The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective     for the treatment of adolescents (ages 13-17) with schizophrenia   "
184921|NCT00257205|"     This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with     surgically incurable metastatic melanoma who have received no prior chemotherapy, or     biochemotherapy for the treatment of metastatic disease. The primary objective of this trial     is to compare overall survival for patients with advanced melanoma who are randomized to     receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or     temozolomide (investigator choice)   "
184922|NCT00257218|"     OBJECTIVE – The role of health promotion for patients with impaired fasting glucose on     preventing or delay the progression of diabetes mellitus has not been widely investigated in     Taiwan. The purposes of this study are to explore the nature history of prediabetes, to     evaluate the incidence of DM in prediabetes and to establish the cohort of people with     prediabetes. Further study will be based on this cohort to evaluate the effect of health     promotion and to compare the concentration of certain protein in their serum, such as     adiponectin.      RESEARCH DESIGN AND METHODS –A total of 600 subjects aged 40-60 years with impaired fasting     glucose (100-125 mg/dl) were randomly selected from the Peng-Hu clinics during January 2003     and December 2003. Anthropometric, biochemical, and metabolic characteristics will be     measured, including weight, height, waist circumference, oral glucose tolerance test,     triglyceride, high and low density cholesterol, blood pressure and insulin resistance etc. A     questionnaire interviews with subjects regarding demographic characteristics is also     performed. 300 subjects will receive education of health promotion. Simultaneously, 150     subjects with normal fasting plasma glucose (<100 mg/dl) will selected for comparison.      Statistical Analysis - Descriptive data will be described as means and SDs for continuous     variables, and analysis of variance (ANOVA) and Chi-square tests were used for assessing the     significances. Bonferroni method was used for post-hoc comparison in ANOVA. Multiple linear     regressions were used for predicting determinants of FPG. We tested the variables scales in     this study for multicollinearity by correlation matrix and VIF (variance inflation factor).     Odds ratios (ORs) and the 95% confidence interval (CI) were calculated to estimate the     relative risk of diabetes mellitus by logistic regression model. A p-value below 0.05 was     considered significant. The statistical analyses were performed with SPSS statistical     Package.   "
184923|NCT00257231|"     The purpose of this study is to help improve our understanding of the biology involved in the     body's response to serious trauma or burn injury. The host response to trauma and burns is a     collection of physiological and pathophysiological processes that depend critically upon the     regulation of the human innate immune system, with particular emphasis on the inflammatory     component of that system. No single research center or small group of centers has the     capacity to delineate the integrated response of this complex biological system, which     involves multiple molecular and genetic interactions that vary in time. Our proposal promotes     the identification of important dynamic relationships that regulate the integration of this     complex biological system, with the expectation that this understanding will ultimately     impact the diagnosis, prognosis, and treatment of the hospitalized, severely injured patient.   "
184924|NCT00257244|"     The purpose of this study is to help improve our understanding of the biology involved in the     body's response to serious trauma or burn injury. The host response to trauma and burns is a     collection of physiological and pathophysiological processes that depend critically upon the     regulation of the human innate immune system, with particular emphasis on the inflammatory     component of that system. No single research center or small group of centers has the     capacity to delineate the integrated response of this complex biological system, which     involves multiple molecular and genetic interactions that vary in time. Our proposal promotes     the identification of important dynamic relationships that regulate the integration of this     complex biological system, with the expectation that this understanding will ultimately     impact the diagnosis, prognosis, and treatment of the hospitalized, severely injured patient.   "
184925|NCT00257257|"     Primary: Effect on HbA1c over 6 months in drug-naive patients with type 2 diabetes      Secondary: Effect on glucose, insulin, C-peptide, insulin resistance, body weight,     HDL-cholesterol, triglycerides, blood pressure - Safety, tolerability   "
184926|NCT00257270|"     This study evaluated the effectiveness of gabapentin in treating tinnitus in two populations:     Tinnitus with associated acoustic trauma and tinnitus without associated acoustic trauma. The     hypothesis was that gabapentin would decrease both subjective and objective features of     tinnitus in the trauma group, but would be less effective in the non-trauma group.`   "
184927|NCT00265252|"     To determine the cumulative incidence of total hip replacement, time to event after treatment     with Fosamax or placebo during the study peroid   "
184928|NCT00265265|"     The purpose of this study is to assess potential interactions between intravenous (i.v.)     cocaine and atomoxetine (Strattera) administered orally in four escalating doses.   "
184929|NCT00265278|"     The purpose of this study is to assess the potential interactions between intravenous     methamphetamine and oral Modafinil.   "
184931|NCT00265304|"     The purpose of this study is to evaluate the long-term safety of IDEA-033 (an     anti-inflammatory pain-relieving drug applied to the skin) in comparison to naproxen (an     anti-inflammatory pain-relieving drug taken by mouth) for the treatment of osteoarthritis of     both knees.   "
184932|NCT00265317|"     This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib     alone in patients with advanced/metastatic lung cancer who have received previous treatment     with a platinum-based regimen   "
184933|NCT00265330|"     The purpose of this study is to assess the safety and tolerability of ziprasidone during     long-term open-label administration in children and adolescents (ages 10-17) with bipolar I     disorder (manic or mixed)   "
184934|NCT00265343|"     This is an extension study to further test      the efficacy and safety of asenapine compared with a      marketed agent (olanzapine) in the treatment of patients with      persistent negative symptoms of schizophrenia.   "
184935|NCT00265356|"     The purpose of this trial is to improve the management of patients with potentially     surgically curable colorectal cancer liver metastases.      The primary objective is to determine the impact of pre-operative positron emission     tomography (PET) on patients who have been assessed as having resectable colorectal cancer     liver metastases by conventional imaging (computed tomography (CT) abdomen/thorax,     colonoscopy), by determining the proportion of patients who have a change in management     resulting from PET.   "
184936|NCT00265369|"     Primary objective:        -  To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo          in children suffering from acute diarrhoea and treated for 7 days.      Secondary objective:        -  To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.   "
184937|NCT00265382|"     The purpose of this study is to assess the safety and tolerability of ziprasidone during     long-term open-label administration in adolescents (ages 13-17) with schizophrenia.   "
184938|NCT00265395|"     This is a controlled, randomized, parallel-groups, open-label, multinational study designed     to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus     Rebetol® (ribavirin) in subjects with chronic hepatitis C. It is designed to evaluate whether     72 weeks of treatment with PEG-Intron plus Rebetol is more effective than 48 weeks of     treatment in subjects with Genotype 1 chronic hepatitis C who exhibit a slow response to     treatment.   "
184939|NCT00265408|"     Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection.   "
184940|NCT00265421|"     We wish to determine wich of two standardized suturing techniques is the best for perineal     repair if a perineal laceration or an episiotomy is present after vaginal birth.      The participants are healthy primi para and deliver at term.   "
184941|NCT00265434|"     Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality     of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a     dysfunction of Chloride channels in exocrine glands, leading to retention of secretions and     consecutive chronic inflammation with bacterial superinfections.      The prospective placebo controlled cross-over study aims at the evaluation of the efficacy of     a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.   "
184942|NCT00265447|"     The purpose of this project is to establish evidence to support specific, targeted exercise     and rehabilitation recommendations for people over 50 with osteoarthritis of the knee.   "
184943|NCT00265460|"     The purpose of this trial is to examine if smokeless tobacco combined with group support     might increase smoking cessation rate compared with groups support in smokers.   "
184944|NCT00265473|"     This clinical trial is designed to extend the observations made in our pilot clinical trial     (IND 8971, Study #1) on the safety and efficacy of immunotherapy with the anti-CD3 monoclonal     antibody hOKT3γ1 (Ala-Ala), (currently called MGA031) combined with sirolimus and tacrolimus     in preventing rejection and autoimmune destruction of deceased donor pancreatic islet     transplants in type 1 diabetic recipients.   "
184945|NCT00265486|"     During facial cooling and especially during breath hold, can mammals - and also humans -     elicit a so called dive reflex, causing bradycardia, peripheral vasoconstriction and     centralization of blood flow to brain, lungs and heart but the reflex is suppressed by     physical activity. The dive reflex can be elicited by breath hold alone and will be more     pronounced during simultaneously facial cooling, but not by stimulation of other skin     receptors.      The dive reflex has an oxygen conserving effect, because of intense vasoconstriction in both     viscera and muscles, and simultaneously with reduction in cardiac output (CO). Therefore     plasma lactate will rise, to compensate for the lesser regional blood flow. If one     hyperventilates with 100 % oxygen, then the reflex can still be elicited, but it is more     pronounced during asphyxia. Experienced sports divers, who has been diving for more than 7-10     years have reduced post apnea acidosis and oxidational stress, but probably also less     sensitivity for progressive hypoxia and hypercapnia, because these individuals have a more     pronounced dive reflex.      Transcranial Doppler ultrasonography (TCD) gives a reproducibly value for brain perfusion by     continuously non-invasive real-time sampling. A single piezo-electrical transducer sends and     collects ultrasound through the temporal region of the scull, where it is the thinnest.     Hereby can the blood flow of arteria cerebri anterior, media (MCA) and posterior and     basilaris be estimated.      With TCD it can be shown that the cerebral blood flow rises in MCA in healthy subjects during     facial cooling, with normal ventilation, when resting in a supine position without affecting     the systemic blood pressure. Single Photon Emission Computerized Tomography (SPECT)-scanning     during normo-baric and hyperbaric pressure of professional divers breathing 100 % oxygen has     shown to reduce the cerebral blood flow in several regions of the brain.      But it is yet unknown how brain blood flow and metabolism are affected by an face immersion     dive and simultaneously prolonged physical activity, and hence a rise in lactate under     hyperbaric pressure (3 meters), breathing atmospheric air, similar to the circumstances for     trained scuba divers work.      Presumably it will cause a fall in brain blood flow and in time cognitive deficits.      Erythropoietin (rhEPO) is a well known drug, used as doping in sports for about 15 years. So     far the only known enhancement in athletic achievement by rhEPO is caused by peripheral     improvements and especially blood capability to transport oxygen to the working muscles; this     has been documented by a rise in haematocrit. rhEPO has also a neuroprotective effect on     neurons in patients with neuron damage caused by cerebral hypoxic ischeamia.      rhEPO work also on a series of cerebral mechanisms, including enhanced motor and spatial     learning and more. Enhanced motor learning may improve the professional divers choices during     work and may be also physical performance and mechanical efficiency. Intravenous injection of     rhEPO will increase rhEPO in cerebrospinal fluids, since rhEPO is capable of crossing blood     brain. All together this may indicate that rhEPO, not only works on physical performance, but     also has effects on the brain. rhEPO has also an effect on the condition of cancer and     dialysis patients, not only explained by merely increased hematocrit.      This project will add new knowledge in the understanding of the mechanisms of clinical use of     rhEPO.      The purpose of this study is to investigate, how brain blood flow and metabolism are affected     by face immersion dive and simultaneously breath hold during normo-baric and hyperbaric     pressure (3 m depth) when breathing atmospheric air in trained sports divers. IL-6, HSP-72,     lactate, ammonium and body-temperature will be measured. Brain and muscle oxygenation will be     measured by near-infrared spectroscopi (NIRS). Furthermore we will investigate whether a     small dose of rhEPO affects mentioned parameters during simulated dive in pressure chamber     with facial cooling.      Hypothesis Brain blood flow in trained divers will be diminished during prolonged physical     activity during simultaneously face immersion dive and breath hold under hyperbaric pressure.      There will be a release of IL-6 and HSP-72. Pretreatment with a small amount of rhEPO before     prolonged physical activity during simulated dive has a protective effect on brain blood flow     and oxygenation.   "
184946|NCT00265499|"     The purpose of this study is to determine whether skeletonization of the internal thoracic     artery leads to improved flow, increased length, improved sternal perfusion, and decreased     pain and dysesthesia in patients undergoing coronary artery bypass surgery   "
184947|NCT00265512|"     The prevalence of substance use disorders (SUD) in the VA is rising, making SUD(s) among the     most commonly diagnosed disorders in the VA. A substantial body of data attests to the     effectiveness of substance use disorder treatment; further the predictor most consistently     associated with positive addiction treatment outcomes is duration. Despite the body of     evidence supporting length of treatment as one of the stronger predictors of long-term SUD     outcomes, only 36% of SUD treatment programs in the VA are meeting the continuing care     performance criterion specified by the Office of Quality Performance. This randomized     clinical trial investigates whether substance use disorder patients assigned to telephone     case monitoring (TCM) for continuing care will do better than those attending face-to-face     continuing care as usual (CCAU)(standard outpatient care).   "
184948|NCT00265525|"     A randomized control trial (RCT) is planned to evaluate a web-based intervention (CardioFit)     against usual care in increasing physical activity levels in patients with Coronary Artery     Disease (CAD). We hypothesize that compared to usual care, participants in CardioFit will; a)     have increased physical activity levels, b) will have a higher health-related quality of life     at measurement dates and, c) will have greater improvements in psychosocial predictors.   "
184949|NCT00265538|"     This study examines the use of patient initiated discussions of blood pressure medication in     the primary care setting. Additionally, this study examines different levels of patient     incentive(s) to initiate discussions with providers including information only, information     plus 20$ incentive and reimbursement for 6 months of copay, and information/monetary     incentive plus a reminder call prior to the index visit. Patient opinions about     doctor/patient relationships will be assessed. Provider attitudes and prescribing behaviors     will be analyzed as well.   "
184950|NCT00265551|"     The purpose of this study is to determine whether a low dose and a high dose of the study     drug SCA-136 are effective and safe in the treatment of schizophrenia requiring     hospitalization.   "
185476|NCT00273884|"     This protocol is designed to assess the safety and efficacy of amonafide in combination with     cytarabine in subjects with previously untreated secondary AML.   "
184967|NCT00267215|"     This trial assessed the safety and efficacy of a single dose of lumiracoxib 400 mg compared     to placebo and to a single dose of celecoxib 200mg. It also assessed safety and efficacy of     400mg lumiracoxib administered once a day for 7 days compared to placebo and to 200 mg     celecoxib twice daily.   "
184968|NCT00267228|"     The aim of the study are:        1. Retrospectively to study the clinical characteristics and features (somatic,          psychological and social variables) of patients treated in Center for Eating Disorders,          Odense University Hospital 1994-2004.        2. To study the predictive power of the psychosocial and morphometric data with regard to          drop outs, relapse and outcome.        3. To investigate eating habits, social functions and quality of life in weight recovered          and chronicly ill patients with eating disorder.   "
184969|NCT00267241|"     The aim of this study is to evaluate the effects in terms of gas exchange, respiratory     mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS     patients.   "
184952|NCT00265590|"     This study will examine specific gene changes in patients with aniridia, a disease in which     the iris (colored part of the eye) is absent or partially absent, and will correlate the     changes with clinical manifestations of the disease. In aniridia, the eye often appears to     have no color, but only a larger than normal pupil. Patients may have impaired vision and     cataracts, glaucoma, nystagmus (rapid, involuntary eye movements), photophobia (light     sensitivity), displaced lens, underdeveloped retina, and thickened cornea. This study will     focus particularly on corneal changes.      Patients 4 years old and older with aniridia may be eligible for this study. Candidates are     screened with a family history and complete eye examination, including the following:        -  Visual acuity testing using a vision chart.        -  Eye pressure measurement.        -  Fundus photography to examine the back of the eye: The pupils are dilated and special          photographs of the inside of the eye are taken to evaluate the retina and measure          changes that may occur over time. The camera flashes a bright light into the eye for          each picture.        -  Slit lamp examination: Evaluation of the front part of the eye with a special microscope          called a slit lamp biomicroscope.        -  Corneal thickness measurement.      Participants have blood drawn for genetic testing related to aniridia. Relevant medical     information, including disease severity and complications, is obtained over time. Family     members may also be requested to provide blood samples for genetic testing.   "
184953|NCT00267033|"     A randomized phase III study of palliative external beam radiotherapy (RTOG 97-14) has shown     that 8 Gy in a single fraction is very effective in providing pain relief, with complete or     partial improvement in pain seen in 66% of patients with bone metastases. Percutaneous     vertebroplasty (PV) is a technique designed to consolidate pathologic vertebral bodies     through the injection of orthopaedic cement under fluoroscopic guidance. Consolidation     provides rapid pain relief to painful vertebral body lesions secondary to osteoporosis,     haemangiomas, myeloma and metastatic diseases, with complete or partial improvement in pain     seen in 70-85% of patients. To date, no randomized trial has tested the association of     vertebroplasty and radiotherapy to enhance pain relief for patients with painful osseous     spine metastases.      A randomized trial has been designed to determine whether vertebroplasty and radiotherapy (8     Gy in a single fraction) provide enhancement pain and narcotic relief compared to     radiotherapy alone for patients with painful osseous spine metastases   "
184954|NCT00267046|"     Primary:        1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and          severity of oral mucositis (OM) in patients with sarcoma receiving multicycle          chemotherapy.        2. To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy.        3. To evaluate the safety profile of palifermin when combined with multicycle chemotherapy.      Exploratory:        1. To evaluate the biologic effect of palifermin on oral mucosa.        2. To investigate potential biomarker development by biochemical analysis in blood cells,          serum, and plasma.        3. To investigate the effects of genetic variation in mucositis genes, drug metabolism          genes, and drug target genes on patient response to the treatment regimen.   "
184955|NCT00267059|"     The goal of this clinical research study is to learn if lenalidomide (Revlimid®) can help to     control CLL in patients who have already received standard therapy. The safety of     lenalidomide will also be studied.   "
184956|NCT00267072|"     The objectives of this study are:        -  To identify women at increased risk for developing ovarian cancer        -  To detect ovarian cancers at an early stage        -  To investigate the role of tumor membrane fragments as tumor markers for early ovarian          carcinoma   "
184957|NCT00267085|"     The goal of this clinical research study is to learn if giving 1 of 2 CML (Chronic Myeloid     Leukemia) vaccines (CML-VAX B2 or CML-VAX B3) together with imatinib mesylate can decrease or     eliminate all evidence of disease in patients who have CML that is in remission after     treatment with imatinib mesylate, but who still have small amounts of detectable disease.   "
184958|NCT00267098|"     Heart failure is a progressive disease that decreases the pumping action of the heart. This     may cause a backup of fluid in the heart and may result in heart beat changes. When there are     changes in the heartbeat, sometimes a pacemaker is used to control the rate and rhythm of the     heartbeat. In this trial, the researchers will test if pacing both the left and right lower     half of the heart (ventricles) will:        -  decrease the number of hospital and clinic visits due to heart failure symptoms        -  extend life        -  delay heart failure symptoms as compared to those who are paced in only one ventricle          (the right ventricle)   "
184959|NCT00267111|"     This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the     pain response in term neonates subjected to intramuscular injection for administration of     vitamin K.      Study Hypothesis: We believe that topical amethocaine gel will be superior to placebo in     decreasing the pain from intramuscular injection in term neonates.   "
184960|NCT00267124|"     The purpose of this study is to determine the effects of exercise and cardiorespiratory     fitness on age-related brain changes.   "
184961|NCT00267137|"     Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the     heart, is the world’s most common kind of irregular heart beat. People with AF experience     symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of     breath, dizziness, fatigue or weakness. Although AF can occur in otherwise healthy people for     no apparent reason, it is sometimes associated with high blood pressure, heart disease or     lung problems. The purpose of the SAFARI trial is to study the effectiveness of pacing     algorithms in the upper chamber of the heart for patients who have both AF and bradycardia     (slow heart beat).   "
184962|NCT00267150|"     Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in     gastrointestinal (GI) complications in some patients. This study will assess if a switch from     MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or     health-related quality of life outcomes and determine the proportion of pancreas-kidney     transplant recipients who experience any GI complaints under MMF-based immunosuppressive     treatment.   "
184963|NCT00267163|"     The goal of this project is to determine if a cholinesterase inhibitor is more effective than     placebo in delaying cognitive and brain functional decline in people at risk for Alzheimer's     disease.   "
184964|NCT00267176|"     This study will investigate the effect on ambulatory blood pressure of lumiracoxib 100 mg     once daily versus ibuprofen 600 mg three times a day in osteoarthritis patients with     controlled hypertension.   "
184973|NCT00267293|"     Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen     (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter     use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to     determine whether giving both medications together is better than giving one medication alone     for the treatment of fever.   "
184974|NCT00267306|"     The purpose of this study is to evaluate the safety and tolerability of visilizumab in     patients with severe ulcerative colitis that has failed to respond to steroid therapy.      What is visilizumab?      Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are     normally made by the immune system to help defend the body from infections and other foreign     substances. Visilizumab is thought to selectively affect the immune system to decrease     inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative     colitis.      Who can participate in this study?      The target population for this study is adults with severe ulcerative colitis that has     resisted intravenous (IV) steroids. This study is open to patients with the following     characteristics:        -  16-70 year olds        -  A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed          within 36 months prior to study entry        -  Active disease despite ongoing treatment with steroids      How is this study conducted?      Eligible participants will be administered visilizumab as one daily injection on two     consecutive days. All medication and study-related care, except for the costs of in-patient     hospitalization, are provided to qualified participants at no cost. This includes all visits,     examinations and laboratory work.      How does one get more information?      This study is currently enrolling patients at hospitals and clinics in North America and     Europe. For more information on the study or how to participate in it, please call     1-800-772-0482, email InfoCenter@pdl.com or visit www.IBDtrials.com.   "
184975|NCT00267319|"     -  The study primarily investigates the effect of copaxone on fatigue during treatment,          compared to baseline in patients with relapsing-remitting multiple sclerosis.        -  Secondary outcome measures are:disability, relapse rate, quality of life and depression.   "
184976|NCT00267332|"     -  The primary objective of this study is to evaluate the efficacy of modafinil in the          treatment of opioid induced sedation as measured by the Epworth Sleepiness Scale (ESS).        -  The secondary objective is to estimate the frequency and severity of toxicity associated          with Modafinil (400mg) in patients with opioid induced sedation.   "
184977|NCT00267345|"     Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis     is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the     chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will     be measured in the chyle as well as hormonal serum level.   "
184978|NCT00267358|"     Anorexia and cachexia are devastating complications in late-stage cancer patients and is     strongly associated with mortality in these patients. Activation of Ghrelin receptors have     been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity     and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced     anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of     RC-1291 HCl in cancer patients with anorexia and cachexia.   "
184979|NCT00267371|"     The purpose of this two arm controlled double-blind study is to determine the safety and     effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the     frequency of migraine headaches, in patients who experience migraine headaches and have a     PFO, compared to medical therapy alone.   "
184980|NCT00267384|"     This randomized, double-blind, placebo-controlled clinical trial will be performed to assess     the effect of N-acetylcysteine therapy on the incidence of nephrotoxicity among patients     hospitalized with an infection and treated with aminoglycosides (AGs). Secondary goals of the     study will be as follows: comparison of the mortality rates, and length of hospitalization     among patients treated with N-acetylcysteine compared to the control group.   "
184981|NCT00267397|"     The purpose of this project is to conduct population based surveillance for prenatally     diagnosed congenital defects amount residents of the five counties to: improve the     comprehensiveness of the Metropolitan Atlanta Congenital Defects Program (MACDP) to (1)     better fulfill its objectives (2) allow assessment of the impact of prenatal diagnosis and     elective termination on the birth prevalence of congenital defects in Atlanta (3) develop a     registry of prenatally diagnosed defects to be used in epidemiologic and genetic studies, in     evaluation prevention programs and in monitoring prenatal diagnostic technology.   "
184982|NCT00267410|"     This project will pilot test a step-by-step guide for community-based organizations to engage     in evidence-based adaptation of interventions previously shown to be effective in research     settings for use in real world applications. The main purpose of this program is to improve     understanding of the processes needed for adapting evidence-based behavioral interventions to     fit new conditions or populations and to pilot CDC-developed draft guidance for adaptation.     The second purpose of the program is to increase the number of effective behavioral HIV     prevention interventions for 18-24 year old sero-positive men of color who have sex with     other men (MSM of color).   "
184983|NCT00267423|"     Hypothesis 1 (H1): Epicardial biventricular pacing is a safe and feasible method of pacing in     young patients.      Over the last two years, physicians at Children’s Healthcare of Atlanta have been implanting     epicardial BiV pacing systems in children determined to have ventricular dyssynchrony caused     by numerous cardiac diagnoses. The decision to use these pacing systems was based on the     knowledge gained by adult studies. Since the use of these pacing systems in the pediatric     population has not been formally studied, we propose a study to retrospectively review the     safety and feasibility of epicardial BiV pacing in pediatric patients. This study will     involve the review of the medical records of children who received epicardial BiV systems at     Children’s Healthcare of Atlanta between January 2002 and May 2004.   "
184984|NCT00267436|"     This project will pilot test a step-by-step guide developed by CDC for organizations to     engage in evidence-based adaptation of interventions previously shown to be effective in     research settings for use in real world applications. The second purpose of the program is to     evaluate the adapted intervention to determine if it is effective in changing behavior of     HIV+ African American men who have sex with other men.   "
184986|NCT00267462|"     The purpose of this study is to identify the patients seen in our practice who are seen with     Hypertrophic Myopathy diagnosis in order to better understand the presenting characteristics     of their disease, the diagnostic testing to determine the diagnosis, the methods used to     follow the disease progression and management practices used in caring for these patients.     The objectives of this data review will be an analysis to determine if there is a methodology     that will foster improved diagnostic speed and accuracy, and determine the best management     practices based on outcomes in these patients.   "
184987|NCT00267475|"     The purpose of this study is to conduct a translational study in patients with primary     eosinophil associated gastrointestinal disorders [EGID] (e.g. eosinophilic esophagitis     eosinophilic gastritis, eosinophilic enteritis [EE], eosinophilic colitis, and eosinophilic     gastroenteritis [EGE]) with the aim of developing a data bank containing pertinent patient     demographic information, tissue samples, and DNA, which will facilitate research on the     pathophysiology of inflammatory disorders and the development of a verified successful     clinical treatment program.   "
184988|NCT00267488|"     The purpose of this study is to find out if Hycamtin given weekly is safe and effective for     treating your endometrial cancer.   "
184989|NCT00267501|"     The purpose of this study is to elucidate the mechanisms underlying eosinophil growth,     survival, migration, and function and to investigate and further characterize the     pathophysiology of, clinical manifestations of, and spectrum of disease severity of     eosinophilic inflammation in humans.   "
184990|NCT00267514|"     The purpose of this study is to determine if sevelamer carbonate powder is an effective     treatment for the control of serum phosphorous levels in patients on dialysis when compared     to sevelamer hydrochloride tablets.   "
184991|NCT00267527|"     This is a multicenter, randomized, placebo-controlled, double-blind, Phase 2 study. Patients     will be treated for a total of 12 weeks. There will be a 6 week follow-up period after the     treatment period ends. Patients will be randomly assigned to low dose CJC 1295, high dose CJC     1295 or placebo.      The objective is to assess and compare the efficacy, pharmacokinetics, safety, and     tolerability of CJC 1295 in patients with human immunodeficiency virus (HIV) associated     visceral obesity.   "
184992|NCT00267540|"     Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone     mass and bone turnover in young girls aged 12-13.      More specifically the effects on the following parameters will be assessed:        -  Vitamin D metabolites.        -  Parathyroid hormone.        -  Bone turnover.        -  Bone mineral accretion.        -  Serum calcium and phosphate.        -  Renal handling of calcium and phosphate.   "
184993|NCT00267553|"     Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29,     and will continue to compare combined hormonal therapy using the experimental aromatase     inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene     (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the     treatment of advanced breast cancer. The purpose of this study is to determine whether     maximal estrogen suppression achieved via the combination of atamestane, plus toremifene     (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast     cancer.   "
184994|NCT00267566|"     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the     effectiveness of the Strongest Families distance intervention compared to usual or standard     care that is typically provided to children with mild to moderate Anxiety symptomology. This     is a single-center trial based at the IWK Health Center. The primary outcome is change in     diagnosis.   "
185028|NCT00268034|"     Collect data to support “standard of care possibility” of extracardiac repair with closure of     intracavitary communication and plication of the aneurysm as probably safest surgical repair     for left ventricular aneurysms.   "
184995|NCT00267579|"     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the     effectiveness of the Strongest Families distance intervention compared to usual or standard     care that is typically provided to children with mild to moderate Disruptive Behaviour     symptomology. This is a single-centre trial based at the IWK Health Centre. The primary     outcome is change in diagnosis.   "
184996|NCT00267592|"     The purpose of this study is to estimate overall survival for adult patients with newly     diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with     concurrent and adjuvant temozolomide. This study will also determine the toxicity and     toxicity rate of talampanel for this therapeutic regimen.   "
184997|NCT00267605|"     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the     effectiveness of the Strongest Families distance intervention compared to usual or standard     care that is typically provided to children with mild to moderate Attention     Deficit/Hyperactivity Disorder. This is a single-centre trial based at the IWK Health Centre.     The primary outcome is change in diagnosis.   "
184998|NCT00267618|"     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the     effectiveness of the Strongest Families distance intervention compared to usual or standard     care that is typically provided to children with mild to moderate Recurrent     Headache/Abdominal Pain symptomology. This is a single-centre trial based at the IWK Health     Centre. The primary outcome is change in diagnosis.   "
184999|NCT00267631|"     Objective: Obesity amongst children is a public health issue in the United States and is     rising at an alarming rate. The purpose of this study is to determine if there is any     correlation between At Risk body weight (overweight and obese) and immediate health of the     pediatric population.      Methodology: As part of routine patient care, we measured length in addition to weight of     patients 2 years to 18 years of age presenting to the pediatric emergency department. A     report was run monthly to calculate the BMI of all patients for whom data is available. The     data were plotted on the year 2000 gender based BMI for age percentile growth charts from     CDC. A retrospective electronic chart review was conducted for patients At Risk body weight     (BMI ≥ 85%), and were compared to control or healthy (BMI of 25 - 75 %) group for six     groups of final ED diagnoses of infectious diseases.   "
185021|NCT00267943|"     The primary objective is to assess the efficacy and safety of the fixed dose combination of     telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) alone or in addition to other     antihypertensive therapies during open-label, long-term treatment.   "
185000|NCT00267644|"     Objective: Although approximately 9% of patients presenting to a Pediatric Emergency     Department (ED) are dehydrated, there is no reliable method to measure objectively the degree     of intravascular dehydration. Respiratory changes in Inferior Vena Cava (IVC) diameter have     been shown to predict volume status in adults. Previous research has demonstrated correlation     between IVC diameter and volume status in children undergoing hemodialysis. Other studies     have shown that IVC diameter in children can be sonographically measured rapidly and     accurately by ED physicians. If we can establish that IVC diameter predicts volume status in     dehydrated children, this tool could assist the ED physician in rapid diagnosis and prompt     resuscitation without the need to wait for blood or urine tests. In this study we use the     dehydrated patient as a model for hypovolemia, with the idea that the data could ultimately     be used in the setting of any hypovolemic state. We aim to evaluate whether ultrasound of the     pediatric IVC can be used to reliably assess volume status.      Methods: This is a prospective cohort study. Pediatric ED patients ranging in age from 1 to     41 months were assessed by a Pediatric emergency physician and stratified as either     clinically euvolemic or hypovolemic. After consent was obtained, one of three Emergency     Medicine Residents performed trans-abdominal sonographic measurements of the IVC diameter.     Measurements of the IVC diameter just caudal to the insertion of the hepatic veins were     obtained in a longitudinal orientation.   "
185001|NCT00267657|"     In this parallel group clinical pharmacology laboratory experiment, we will assess     pharmacodynamic interactions (with a focus on cardiovascular effects) of a 15 mg intravenous     methamphetamine dose and single oral doses of reserpine (0.5 and 1.0 mg) or placebo.   "
185002|NCT00267670|"     The purpose of this study is to explore the potential benefit of the medication,     pentoxifylline, for the treatment of NASH.   "
185003|NCT00267683|"     This trial is conducted in Japan. This is a clinical trial to study the efficacy and safety     of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.   "
185004|NCT00267696|"     The purpose of this study is to test the effectiveness, safety and tolerability of the drug     combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed     with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal     cancer.   "
185005|NCT00267709|"     The purpose of the study is to evaluate an intravenous (by injection) investigational     medication to treat Crohn's disease in patients with at least one perianal fistula. The     research is being conducted at up to 5 clinical research sites in the US and Europe and is     open to both men and women ages 18 to 70 years old. Participants in the study will have a     number of visits to a research site over a 17 month period. All study-related care and     medication is provided to qualified participants at no cost: this includes all visits,     examinations and laboratory work.      Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the     immune system to help defend the body from infections and other foreign substances) that is     directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing     so, it may prevent them from causing inflammation. Visilizumab has also been observed to have     a suppressive effect on the body's immune system (system in the body that reacts to foreign     or occasionally one's own proteins).   "
185006|NCT00267722|"     The purpose of the study is to evaluate an intravenous (by injection) investigational     medication to treat moderate to severe inflammatory, nonstricturing, nonpenetrating Crohn's     disease. The research is being conducted at up to 5 clinical research sites in the US and     Europe and is open to both men and women ages 18 to 70 years old. Participants in the study     will have a number of visits to a research site up to 17 months. All study-related care and     medication is provided to qualified participants at no cost: this includes all visits,     examinations and laboratory work.      Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the     immune system to help defend the body from infections and other foreign substances) that is     directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing     so, it may prevent them from causing inflammation. Visilizumab has also been observed to have     a suppressive effect on the body's immune system (system in the body that reacts to foreign     or occasionally one's own proteins).   "
185007|NCT00267735|"     The objective of this proposed 18-month exploratory research study is to help pregnant women     weigh risks and benefits in a childbirth decision using the Preferences-Assessment Computer     Module. Our hypothesis is that, after using this computer module, women will be more aware of     the potential risks and benefits of VBAC and of elective repeat cesarean and will have     greater clarity about their preferences related to these risks and benefits.   "
185008|NCT00267748|"     This trial has two parts. The purpose of the first part of the trial is to determine the     doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in     combination. This part is currently closed to enrollment.      The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2     schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying     progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule.     The trial will also determine the number of patients whose cancer responds to the treatments,     whether life of patients can be extended, what the side effects are of the treatments, how     bothersome disease or treatment-related symptoms are to patients, and whether tests can be     found that will predict which patients may or may not respond to these treatments in the     future.   "
185009|NCT00267774|"     In this multicenter, international study we are evaluating two approaches to determine which     coronary artery narrowings require stent placement in patients with multivessel coronary     artery disease. Patients will be randomized to an angiographic strategy, where only coronary     angiography is used to determine which lesions to stent or to a pressure wire strategy where     fractional flow reserve, an index measured with the pressure wire, will be used to determine     which lesions to stent. The primary outcome will be major adverse cardiac events at 1 year. A     secondary outcome will be cost-effectiveness.   "
185010|NCT00267787|"     Study the Genetics of Anal Cancer   "
185011|NCT00267800|"     The cause of most interstitial lung diseases (ILDs) is still unknown. Further research, for     example to determine predisposing genetic factors, is therefore needed. A database with     relevant clinical data and DNA/serum samples of ILD patients could facilitate future research     on the cause of ILDs.   "
185012|NCT00267813|"     Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated     craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion     (Zyban). We compare cue-induced reactivity to smoking videos in smokers who were successfully     treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic     activity in response to smoking and neutral cues in Positron Emission Tomography using FDG.   "
185013|NCT00267826|"     Protocol Title: Immunopharmacological effects of Rituximab in atopic dermatitis      Study Phase: Investigator driven study      Study Design: Open-label, single center.      Primary Study Objective: To determine the efficacy, safety and immunopharmacological effects     of Rituximab (anti-CD20) administered as a 1000mg intravenous infusion on days 1 and 15 to     patients with atopic dermatitis.      Secondary Study Objective: To investigate key immunological parameters involved in the     pathology of this common skin disease to interpret the clinical findings.      Number of Patients: 6      Study Population: Male and female patients, at least 18 years of age with atopic dermatitis,     active inflammation, a severity score of 6-9 according to Langeland and Rajika.      Treatment Group: Rituximab will be administered as 1000 mg infusion intravenously at day 1     and 15, followed by a 24-week follow-up period.      Visit Schedule: Screening Visit (within 28 days prior to Visit 1) Treatment visits (Visits     days 1, 3, 8, 15, 17) Follow-up Visits (Visits weeks 4, 8, 12, 16, 20, 24)      Visit 11/Early Termination Visit (if applicable) Visit 11 will serve as the Early Termination     Visit for any patient who withdraws from the study between Visit 1 and 10.      Efficacy Parameters:      Clinical parameters:      EASI Patient Assessment of Pruritus / Pruritus score Physician Global Assessment (PGA)     Photography      Laboratory analysis:      Differential blood count Total IgE, specific IgE (aeroallergen panel) Immunophenotyping of     PBMC Lymphocyte proliferation following pan-T stimulation with PHA Cytokine release from     blood T cells following pan-T stimulation with PHA      Skin tests Histopathology of skin biopsies      Safety Parameters: Physical examinations; vital signs; selected blood chemistry, including     liver function tests, creatinine; white blood cell count (WBC; including total lymphocyte     count); platelets, lymphocyte subset analysis; complement, immunoglobulins (IgA, IgM, IgG,     IgE), monitoring for infections; monitoring for concomitant therapies; monitoring for adverse     events.   "
185014|NCT00267839|"     The purpose of this study is to determine whether exercise training may impact relevant risk     factors and health costs of community living women older 65 years.   "
185015|NCT00267852|"     This is an observational prospective, multicenter study. The aim of the study is to evaluate     how the Italian population of patients are treated with early aggressive RA, defined by the     Italian Society of Rheumatology Guidelines, (GIARA Registry Study Group. Clin Exp Rheumatol     2003;21(Suppl. 31):S129-S132), in rheumatologic clinical practice and whether recent     scientific evidence or new treatments available to rheumatologists can change their practice     in a 2 year follow-up. The observation will primarily focus on the disease activity and     clinical remission in patients who are receiving different treatment strategies. The primary     goal is to define prevalence of clinical remission, according to the (Disease Activity Score)     DAS 28 definition of clinical remission, in patients with early aggressive RA receiving     different therapies at 1 year.      Secondary objective are assessment of:        -  Prevalence of Remission at the second year        -  Disease activity at the first and second year.        -  ACR 20%, 50%, 70% response at the first and second year.        -  Quality of Life in patients with or without remission at the first and second year        -  Safety Evaluations   "
185016|NCT00267865|"     This study will investigate the use of chemotherapy plus highly active antiretroviral therapy     (HAART) in patients with AIDS-related primary brain lymphoma. None of the drugs used in this     study are experimental, but chemotherapy plus HAART has not been established as a standard     treatment in patients with AIDS. The chemotherapy regimen used in this study (see below) was     chosen because it may be less toxic to immune cells called T-lymphocytes than most drug     treatments for lymphoma.      People with AIDS 18 and older and have primary brain lymphoma may be eligible for this study.     Candidates are screened with a medical history and physical examination, MRI, CT and PET     scans, cerebrospinal fluid studies, brain biopsy at tumor sites, if possible,     electrocardiogram and blood tests.      Participants undergo six 2-week induction treatment cycles of HAART plus chemotherapy with     methotrexate, rituximab and leucovorin, followed by two 4-week consolidation treatment     cycles using HAART, methotrexate and leucovorin, and then HAART alone. Rituximab is given by     intravenous (IV, through a vein) day 1 of each cycle. Also on day 1 IV fluids are given to     lower acidity in the urine to protect the kidneys from the methotrexate. On day 2,     methotrexate is infused through a vein over 4 hours. Starting 24 hours after initiation of     the methotrexate infusion, leucovorin is given every 3 to 6 hours (first IV and then possibly     by mouth) until the drug decreases to a target level in the blood. HAART is begun as soon as     possible. The specific HAART regimen for each patient is determined individually. All     patients are hospitalized the first week of every 2-week treatment cycle for safety     monitoring. In addition to HAART and chemotherapy, patients undergo the following tests and     procedures:        -  Intellectual functioning: Before starting treatment, patients are tested for their          ability to understand basic concepts and coordination in order to be able to evaluate          how the brain lymphoma affects thinking and concentration. After the lymphoma appears to          have resolved, more formal and intensive tests are done. The intensive tests are          repeated each year, and shorter, interim tests are done about every 6 months. Also, a          specialist periodically monitors patients' understanding of HAART and the importance of          this therapy.        -  Blood tests: Blood is drawn every day during hospitalizations to measure methotrexate          levels and to evaluate kidney and liver function and blood counts. Blood is also drawn          before starting therapy, when the lymphoma disappears, 6 months after completing          treatment, and any time it appears that the lymphoma may have recurred to test for          Epstein-Barr virus (EBV), a virus that is almost always present in AIDS-related primary          brain lymphoma.        -  Imaging tests: Patients undergo magnetic resonance imaging (MRI) and positron emission          tomography (PET) scans periodically to monitor the effects of treatment on the lymphoma.          MRI scans are done after the 2nd, 4th, 6th, and 8th treatments, then every 2 months for          three times, every 3 months for six times, every 6 months for four times, and then every          year for 5 years, or sooner if there is a concern about the brain. PET scans are done          after the first cycle, after the MRI suggests the lymphoma is gone, and then yearly.        -  Lumbar puncture (spinal tap): This test is done to look for EBV in the cerebrospinal          fluid (CSF). Under local anesthetic, a needle is inserted in the space between the bones          in the lower back where the CSF circulates below the spinal cord and a small amount of          fluid is collected through the needle. This test is done at the same times as the blood          tests for EBV.        -  Eye examinations: Patients' eyes are examined periodically because brain lymphoma can          sometimes spread to the eye and because some people with AIDS-related primary brain          lymphoma are at risk of certain eye infections.   "
185017|NCT00267891|"     This study will use functional magnetic resonance imaging (fMRI) to examine what happens in     the brains of adolescents when they are exposed to violent media and how imagining aggressive     behavior affects brain function. The study will measure physiological changes (such as the     amount of electricity generated by the skin, heart rate, and breathing rate) related to these     tasks during fMRI. MRI uses a magnetic field and radio waves to obtain images of body organs     and tissues. For fMRI, the subject performs certain tasks during the MRI scanning to examine     changes in the brain regions that are involved with those tasks. During the scan, the subject     lies in a metal cylinder (the scanner), wearing earplugs to muffle loud noises that occur     with the scanning.      Healthy right-handed native English-speaking males between 14 and 17 years of age may be     eligible for this study. Candidates are screened with a neurological examination and     neuropsychological testing that includes questions about their feelings, experiences, and     behavior, and tests of reading level and intelligence.      Participants undergo fMRI and fill out questionnaires before and after the scanning. Some     children are asked to play 20 minutes of video games before the test. During the scan, the     child views short neutral video clips and video clips of people fighting or imagine     self-defense situations. The child is asked to rate the video clips for their aggressive     content or tell how he or she feels about the imagined situations. Two small straps are     wrapped around the child's index and middle fingers to measure changes in the amount of     electricity generated by the skin, and a strap at the ring finger measures the child's heart     rate. A band around the child's chest records breathing rates.      Children who cannot or do not want to undergo MRI testing may be asked to view commercially     available video clips of people fighting and neutral video scenes, such as sports scenes.     They are asked to rate them on their violent content and excitement, or to rate the video     games they have played on their violent/nonviolent content and their popularity. In addition,     the children fill out questionnaires about their media use and exposure to violence.      All participating families are contacted by telephone 1 day and 2 weeks after the experiment     for parents to answer questions about how the child has been doing and for the children to     answer questions about their feelings.   "
185018|NCT00267904|"     Objectives: Plasma levels of catechols have distinct meanings in terms of indicating     functions of endogenous catecholamine systems. This Protocol is designed to enable ongoing     quality assurance of diagnostic and research assays of catechols and their metabolites and to     identify possible influences of demographic and anthropometric factors, dietary constituents,     and conditions of sampling on reference values.      Study Populations: The study population is healthy volunteers and people who are obese or     have untreated hypertension.      Design: Arm venous blood is drawn via an indwelling i.v. catheter from healthy volunteers     across demographic and anthropometric spectra (age, gender, skin color, ethnicity, body mass,     adiposity), to obtain quality control plasma and establish reference values for plasma levels     of catechols and their metabolites. Non-invasive physiological measures are obtained     concurrently. Levels of catechols and their metabolites are related to results of common     clinical pathology tests. Subgroups of subjects are tested more than once, to assess dietary     influences (cereal with milk, coffee) and conditions of sampling (temperature at the skin).      Outcome Measures: The main non-experimental outcome is an ongoing pool of quality control     plasma. The main experimental outcome measures are plasma concentrations of catechols and     their metabolites, non-invasive physiological measures, and results of common clinical     pathology tests. Subject groups are compared with respect to the above demographic and     anthropometric factors. Effects of the experimental manipulations are assessed within     subjects   "
185019|NCT00267917|"     The objective of this trial is to compare the total and regional deposition of aerosol in the     lungs and oropharynx of patients with COPD and known poor MDI inhalation technique following     inhalation of Berodual? delivered via the Respimat? inhaler and Berodual? delivered via an     HFA-metered dose inhal er achieved with their natural inhalation technique compared with     taught optimal technique.   "
185020|NCT00267930|"     This study is designed to evaluate the safety, tolerability and preliminary efficacy of     vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours     and less than 6 months duration   "
185022|NCT00267956|"     The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275     (ustekinumab) in patients with psoriatic arthritis.   "
185024|NCT00267982|"     A retrospective chart review will be performed on 50 patients who received RFA for the     treatment of EAT between August 1992 and August 2003 at Children's Healthcare of Atlanta.      The use of the CARTO/Biosense catheter has improved outcomes with decreased radiation     exposure to patients.   "
185025|NCT00267995|"     The Ross procedure has become the surgery of choice for aortic valve replacement in children.     This consists of taking a child's own pulmonary valve (the autograft) and replacing the     child's diseased aortic valve with the autograft. At times, this can involve either enlarging     or reducing the diameter of the aortic annulus to make the valve fit properly. The patient's     own pulmonary valve is then replaced, most typically with a human heart valve (a homograft).     There has been some concern in the literature that as time goes on, the autograft will dilate     and the patient will develop progressive aortic insufficiency.      Since 1994, we have performed almost 50 Ross procedures in children and young adults.     Contrary to many reports from the literature, we have not recognized a problem with autograft     enlargement and progressive aortic insufficiency. One thing that we have done differently     from other centers is that we have modified the insertion technique of the autograft into the     native aortic root. This involves a second buttressing suture layer. Not only does this have     the immediate effect of reducing bleeding complications, we postulate that it has the     long-term effect of stabilizing the autograft and preventing aortic root dilatation.      We hypothesize that this proximal buttressing technique for the Ross procedure has a two-fold     benefit. Firstly, it reduces the amount of bleeding in the postoperative period. Secondly, it     prevents late autograft root dilatation.   "
185026|NCT00268008|"     The primary objective of this retrospective study of valve replacement is to document     long-term survival and occurrence of valve related complications such as described in the     literature; anticoagulant related bleeding event , thromboembolic events, subacute bacterial     endocarditis (SBE), structural failure or deterioration , valve thrombosis, explantation and     reimplantation with reason, death and death cause, and cerebrovascular accidents either     permanent or transient in nature.      Secondary to this is the presumption that mechanical valves have a superior “life expectancy     “ to bio-prosthetic valves. We plan to look at the time of freedom from re-implantation from     different types of valves, factoring in patient age, size ,defect and risk factors.      The information learned from this study may benefit future patients who undergo the Ross     procedure by increasing our knowledge of safer and/or more effective techniques.   "
185027|NCT00268021|"     Automated implantable cardioverter defibrillators ,AICD, and Biventricular,BiV, Pacemakers     have been shown in randomized trials to offer an advantage in adults with decreased     ventricular ejection fraction, heart failure, spontaneous non-sustained ventricular     tachycardia VT, inducible non-suppressible VT and the combination of low ejection fraction     and prior myocardial infarction,14. Pediatric patients with a variety of different heart     abnormalities are at high risk for life threatening arrhythmias and poor ventricular function     or heart failure,16. Therefore, extrapolating this adult data, AICDs and BiV pacemakers have     been used with increasing frequency in the pediatric and congenital heart disease population.     Improvements in device size and lead design allows AICD and BiV implantation in the very     young, in small size patients and in patients with complex cardiac anomalies,1. The use of     BiV pacemakers and the patterns of AICD discharge are similar in young patients and in     adults, suggesting that the risk of life threatening arrhythmia and heart failure are also     similar,16. However, this patient population behaves differently from the adult population in     the incidence of pacemaker complications, circadian arrhythmias,7, and more importantly, a     relatively high incidence of complications related to AICD insertion, 8. There is a need for     more studies to establish the risk-benefit ratio of these devices in the pediatric setting.   "
185029|NCT00268047|"     Clinical evidence reveals that some patients who undergo cardiac transplantation exhibit     problems with pulmonary vascular resistance as well. In some studies, an increase in     pulmonary vascular resistance has been used as an indicator for increased 3-day and 3-month     mortality after heart transplantation2. In this study, the investigators would like to look     at pulmonary vascular resistance in patients with a surgical history of the Fontan procedure     followed by heart transplantation.   "
185030|NCT00268060|"     Infants with congenital long QT syndrome (LQTS) and 2:1 atrioventricular block (AVB) have     been recognized as a clinical subset of children with LQTS.      The purpose of this study is to describe the clinical course and outcome of a patient with     congenital long QT syndrome (LQTS).   "
185031|NCT00268073|"     The records of all the patients that underwent the Norwood-Sano operation at Children’s     Healthcare of Atlanta, Emory University between January 1, 2002 and December 31, 2004 will be     investigated. These patients will be compared with an equal number of consecutive cases     treated by classic Norwood stage I operation in order to determine the incidence of     neo-aortic valve insufficiency and the clinical outcome of these patients.   "
185032|NCT00268086|"     The primary aim of this study is to determine the clinical and radiographic findings with     constrictive pericarditis in the adult congenital population and determine the degree of     right heart failure and dilation from pulmonary insufficiency in the presence of constrictive     pericarditis      The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and     elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.   "
185033|NCT00268099|"     The primary aim of this study is to determine the optimal timing for repair of right-to-left     shunt lesions such as Tetralogy of Fallot defects.      The secondary aim being define the criteria for failing medical therapy.   "
185034|NCT00268112|"     Spontaneous resynchronization of dyskinetic segments of the left ventricle occurs after     coronary bypass surgery in adults and has been shown in some children. It is, however,     unknown what degree of dyskinesis is likely to be reversible in infants with ischemia from     anomalous coronary arteries and what criteria would indicate that a resynchronization     strategy of biventricular pacing might be needed.      These questions need data from quantitative serial tissue Doppler observations of patients     from pre-operative to late post-operative follow-up.   "
185035|NCT00268125|"     The purpose of this study is to demonstrate a betterment of the digestive symptomatology by     the anti-emetic acupression's bracelets's use associated with hygiene and dietetic advices.   "
185036|NCT00268138|"     the objective of this phase IV study: to establish the efficacy of elmex gel with a fluoride     concentration of 1.25% compared with placebo by determining prevention of white spot lesions     in patients wearing fixed orthodontic appliances.   "
185037|NCT00268151|"     The purpose of this study is to determine the most suitable dose of Oxaliplatin that can be     safely given in combination with a low fixed dose of Capecitabine and a limited volume of     radiation in patients with non-small cell lung cancer.   "
185038|NCT00268164|"     The purpose of this study is to determine whether the lactic acid bacteria  Lactobacillus     acidophilus (LA5) and Bifidobacterium animalis subsp. lactis (BB12) is effective as     maintenance treatment in ulcerative colitis.   "
185039|NCT00268177|"     This study was designed to look at effects of salmeterol/fluticasone propionate compared to     placebo on airway inflammation in patients with chronic obstructive airways disease   "
185040|NCT00268203|"     This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab     (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or     transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine     I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain     additional safety and efficacy information for this treatment regimen. Post study drug     administration follow-ups will continue for up to ten years. These will include blood-work     and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week     13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years     from the dosimetric dose and then annually thereafter through year 10. Thyroid function will     be monitored annually during Long-term follow-up.   "
185041|NCT00268216|"     The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the     survival of subjects with COPD and also assess the long term safety profile of this drug.   "
185042|NCT00268229|"     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving imatinib mesylate together with daunorubicin     and cytarabine may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate     when given together with daunorubicin and cytarabine in treating patients with relapsed acute     myeloid leukemia.   "
185043|NCT00268242|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and mitoxantrone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer     cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with     mitoxantrone works in treating patients with relapsed acute myeloid leukemia.   "
185044|NCT00268255|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells.     Gefitinib may make tumor cells more sensitive to radiation therapy. Giving gefitinib together     with radiation therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation     therapy when given together with gefitinib and to see how well they work in treating patients     with inoperable stage I or stage II non-small cell lung cancer.   "
185054|NCT00268398|"     PURPOSE: This randomized phase III trial is studying two different combination chemotherapy     regimens to compare how well they work in treating patients with colorectal cancer and     resectable metastases.   "
185182|NCT00260676|"     The aim of the study is to verify if a PROTECTIVE ventilatory strategy (low tidal volume     and high PEEP, application of CPAP during the apnea test and recruitment maneuvers), improves     lung function and increases the number of lungs eligible for transplantation.   "
185045|NCT00268281|"     Heart failure is a progressive disease that decreases the pumping action of the heart. This     may cause a backup of fluid in the heart and may result in heart beat changes. When there are     changes in the heart beat sometimes an implantable heart device is used to control the rate     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may     be prescribed.      Left Ventricular Capture Management (LVCM) refers to the overall method for determining left     ventricular thresholds (level of energy needed to effectively pace the tissue in the lower     left chamber of the heart) by measuring, analyzing, and adjusting energy delivered from the     CRT device to the pacing lead.      The purpose of the Left Ventricular Capture Management Software Download Clinical Trial was     to evaluate the accuracy of the Left Ventricular Capture Management (LVCM) feature to support     LVCM feature approval in future cardiac resynchronization therapy with defibrillation (CRT-D)     devices   "
185046|NCT00268294|"     Heart failure is a progressive disease that decreases the pumping action of the heart. This     may cause a backup of fluid in the heart and may result in heart beat changes. When there are     changes in the heart beat sometimes an implantable heart device is used to control the rate     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be     prescribed.      People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating,     may be in need of an electronic device called an implantable cardioverter defibrillator     (ICD).      Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart.     People with AT may experience symptoms such as heart palpitations (a racing or pounding     feeling in the chest), shortness of breath, dizziness, fatigue or weakness.      The purpose of this study is to characterize the impact of cardiac resynchronization therapy     versus cardiac resynchronization therapy with atrial therapies on the incidence, duration and     termination of atrial tachyarrhythmias.   "
185047|NCT00268307|"     The goal of this study is to determine the safety of giving a patient's own bone     marrow-derived stem cells delivered with a catheter (tube) into the coronary arteries (blood     vessels of the heart). Stem cells are simple cells produced by the bone marrow that can     develop into many types of cells. It is possible that these cells will decrease the size of     damage caused to the heart from a heart attack and increase the pumping efficiency of the     heart; which can be decreased due to a heart attack. The stem cells will be taken from bone     marrow and then given back into the heart vessels.   "
185799|NCT00277433|"     The primary goal of the study is to investigate the impact of a common genetic polymorphism     in a histamine detoxification enzyme that may well have a common role in regulating the     expression of atopic dermatitis (AD) and other related atopic diseases in children.   "
185048|NCT00268320|"     Heart failure is a progressive disease that decreases the pumping action of the heart. This     may cause a backup of fluid in the heart and may result in heart beat changes. When there are     changes in the heart beat sometimes an implantable heart device is used to control the rate     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be     prescribed.      People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating,     may be in need of an electronic device called an implantable cardioverter defibrillator     (ICD).      Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart.     People with AT may experience symptoms such as heart palpitations (a racing or pounding     feeling in the chest), shortness of breath, dizziness, fatigue or weakness.      The purpose of this study is to study an investigational implantable device containing     Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD)     therapies (CRT+ICD device) in subjects who are at significant risk of developing atrial     tachyarrhythmias.   "
185049|NCT00268333|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving more than one drug (combination chemotherapy) together with radiation therapy may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with radiation therapy works in treating patients with recurrent metastatic colorectal     cancer.   "
185050|NCT00268346|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with     recurrent or metastatic esophageal or gastroesophageal junction cancer.   "
185051|NCT00268359|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such     as irinotecan, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may     kill more tumors cells.      PURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving     bevacizumab together with irinotecan works in treating patients with recurrent or refractory     gliomas.   "
185052|NCT00268372|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It     is not yet known whether giving combination chemotherapy together with radiation therapy is     more effective than giving cisplatin together with radiation therapy in treating cancer of     the oropharynx.      PURPOSE: This randomized phase III trial is studying combination chemotherapy and radiation     therapy to see how well they work compared to cisplatin and radiation therapy in treating     patients with stage III or stage IV cancer of the oropharynx.   "
185053|NCT00268385|"     This phase I trial is studying the side effects and best dose of vorinostat when given     together with temozolomide in treating patients with malignant gliomas. Drugs used in     chemotherapy, such as vorinostat and temozolomide, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may     also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Vorinostat may help temozolomide work better by making tumor cells more sensitive to the     drug. Giving vorinostat together with temozolomide may kill more tumor cells.   "
185055|NCT00268411|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It     is not yet known whether giving both of these drugs on the same day is more effective than     giving them on different days.      PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine     and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic     cancer.   "
185056|NCT00268437|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving radiation therapy together with pemetrexed disodium and     carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed.      PURPOSE: This phase II trial is studying how well giving radiation therapy together with     pemetrexed disodium and carboplatin works in treating patients with locally advanced     esophageal cancer that can be removed by surgery.   "
185057|NCT00268450|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine, and paclitaxel, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor     growth in different ways. Some find tumor cells and kill them or carry tumor-killing     substances to them. Others interfere with the ability of tumor cells to grow and spread.     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.     Giving combination chemotherapy together with bevacizumab before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed. Giving these     treatments after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving cisplatin, bevacizumab, and     gemcitabine followed by surgery, bevacizumab, and paclitaxel works in treating patients with     locally advanced nonmetastatic bladder cancer that can be removed by surgery.   "
185092|NCT00268931|"     The specific purpose of this study is to determine the effect of movement training on the     onset of motor skills in babies born prematurely. We hypothesize that infants who participate     in movement training will show advances in motor skills, visual attention, and toy-oriented     behavior.   "
185058|NCT00268463|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Hepatic arterial infusion uses a catheter to carry tumor-killing     substances, such as chemotherapy, directly into the liver. Giving chemotherapy in different     ways may kill more tumor cells. It is not yet known whether giving oxaliplatin and     capecitabine together with an hepatic arterial infusion with floxuridine is more effective     than giving oxaliplatin and capecitabine alone in treating patients who are undergoing     surgery and/or ablation for liver metastases due to colorectal cancer.      PURPOSE: This randomized phase III trial is studying oxaliplatin, capecitabine, and an     hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin     and capecitabine in treating patients who are undergoing surgery and/or ablation for liver     metastases due to colorectal cancer.   "
185059|NCT00268476|"     Prostate cancers depend upon the male hormone testosterone for their growth. Lowering     testosterone levels (either by removing all or part of both testes, or by giving anti-hormone     treatment) slows the growth of prostate cancers. This type of treatment is called hormone     treatment and is often used when prostate cancers have spread outside of the prostate gland.     Although hormone treatment is usually successful at stopping the cancer growing for a period     of time, the cancer will begin to grow again in most men.      There are increasing numbers of treatments available for advanced prostate cancer. These     treatments are usually used in prostate cancer when hormone treatment is no longer effective     and the cancer has started to grow again. The aim of this trial, which is called STAMPEDE, is     to assess five of these treatments, given earlier in the course of the disease in combination     with hormone treatment.      The treatments assessed during the trial are:        1. Zoledronic acid: Prostate cancer cells can spread to bones and weaken them. Zoledronic          acid is a drug that reduces bone destruction and hardens bones. This may make them more          resistant to attack by cancer cells.        2. Docetaxel: A drug that stops cells replicating, Docetaxel is currently being used to          treat a range of cancers including lung, breast and ovarian cancer as well as prostate          cancer. Docetaxel is already known to prolong survival in men with relapsed metastatic          prostate cancer.        3. Celecoxib: An aspirin-like drug that is used to treat arthritis. Celecoxib slows down          the growth of cancer cells in the laboratory. We wished to see if it had the same effect          on cancer cells in patients. Recruitment to new patients for the evaluation of this drug          is finished as a pre-planned interim analysis failed to demonstrate sufficient activity.        4. Abiraterone (included from protocol version 8.0): An inhibitor of steroid hormone          synthesis that blocks prostate cancer cells from generating their own male hormones.          This is thought to be a major way in which prostate cancer cells resume growth following          castration based therapies. This agent is given along with prednisolone and is already          known to prolong survival when given to men following failure of docetaxel chemotherapy.        5. Prostate radiotherapy (included from protocol version 9.0): Treatment with high-energy          x-rays targeted to the prostate gland. This treatment is now mandatory for patients with          cancer that is confined to the prostate gland as large trials have shown it improves          survival times. We are interested in whether we should give radiotherapy to the prostate          if the cancer has already spread.        6. Enzalutamide (included from protocol version 12.0): This is a blocker of androgen          receptors. These stimulate the cancer when hormone therapies have failed. Enzalutamide          may be mutually complementary to abiraterone in terms of blocking mechanisms of          resistance. The agent prolongs survival when given to men following failure of docetaxel          chemotherapy.      STAMPEDE will look at the effect of combining one or two of the treatments described above     with hormone treatment. A computer program will be used to allocate which treatment the     patient receives, using a chance process. The trial will look at the effects of the combined     treatments on quality of life and find out whether the new treatment combinations increase     the time when the cancer is not growing and ultimately results in patients living longer. The     study will also look at which treatment provides the greater value for money for the health     service. More than 8,000 patients will join the trial with answers becoming available over 7     to 12 years.   "
185060|NCT00268489|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium     together with bevacizumab may be an effective treatment for non-small cell lung cancer.      PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with     bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.   "
185061|NCT00268502|"     RATIONALE: Studying quality of life in cancer survivors may help determine the long-term     effects of breast cancer and may help improve the quality of life for future cancer     survivors.      PURPOSE: This clinical trial is studying the quality of life in African-American or Caucasian     female breast cancer survivors.   "
185062|NCT00268515|"     To evaluate the efficacy of aerosolized cyclosporine given in addition to the standard oral     immunosuppressive drug regimen, in preventing acute rejection immediately after lung     transplantation   "
185063|NCT00268528|"     This clinical trial is assessing compliance with long-term mercaptopurine treatment in young     patients with acute lymphoblastic leukemia in remission. Assessing why young patients who     have acute lymphoblastic leukemia may not take their medications as prescribed may help     identify ways to assist them in taking their medications more consistently and may improve     long-term treatment outcomes.   "
185064|NCT00268541|"     Offspring of patients with type 2 diabetes have increased risk of developing diabetes and are     typically more insulin resistant than their peers with no diabetes family history. We have     recently demonstrated that, in contrast to their sedentary counterparts, physically active     offspring are not insulin resistant. In the proposed controlled clinical study, we will     examine the effects of a moderate exercise programme on insulin resistance, and other     metabolic risk factors, in sedentary offspring and matched control subjects. We hypothesise     that offspring will exhibit an augmented response to exercise, thereby normalising their     predisposition to an adverse metabolic profile. We will also investigate expression of     adipokines and other genes in adipose tissue to determine whether these contribute to the     increased insulin resistance observed in offspring and whether they are influenced by     exercise. The results will help to determine the efficacy of exercise in normalising     metabolism in offspring and will help elucidate the mechanisms involved.   "
185065|NCT00268554|"     The purpose of this study is to determine whether dipyridamole enhances postocclusive     reactive hyperaemia by increasing extracellular adenosine concentrations during ischemia and     reperfusion. Furthermore we hypothesize that dipyridamole augments postocclusive reactive     hyperaemia by increasing adenosine receptor stimulation.   "
185080|NCT00268762|"     Is the combination of low doses of argatroban in combination with rt-PA safe, and does it     increase recanalization in patients with acute ischemic stroke.   "
185081|NCT00268775|"     The purpose of this study is to compare the effect of two implementation strategies for a     simple patient-directed intervention to reduce long-term benzodiazepine use in Dutch     community pharmacies.   "
185066|NCT00268567|"     lupus nephritis accounts for the most morbidity and mortality in patients with SLE.     Glucocorticoids combined with cyclophosphamide (CYC) are effective for the treatment of     patients with proliferative lupus nephritis and have been the immunosuppressive regimen of     choice for many years. However, some patients do not respond well to the regimen, and adverse     effects of cyclophosphamide limit its use in certain patients. Leflunomide is a novel     immunosuppressive agent currently used in the treatment of rheumatoid arthritis.There were a     few pilot observational studies and reports suggesting leflunomide was also safe,     well-tolerated and may be effective in SLE patients without important organ involvement. It     has not been shown if leflunomide can be used in the treatment of patients with lupus     nephritis. We therefore undertook a multi-center, controlled study to investigate the     efficacy and safety profile of leflunomide compared with cyclophosphamide in the treatment of     patients with biopsy proven proliferative lupus nephritis.   "
185083|NCT00268814|"     The study will test the hypotheses that heroin assisted treatment, compared to methadone     maintenance treatment, is more effective with regard to        -  the improvement of health,        -  reduction of illicit drug consumption,        -  decrease of criminal behaviour,        -  rise in the accessibility and retainment,        -  detachment from a social drug context,        -  social stabilisation in the sense of new drug-free contacts, improved vocational          circumstances, financial security, stabilisation of the living situation,        -  enrollment in subsequent treatment in the case of heroin dependent persons who could not          be effectively reached or successfully treated so far, and it will check which is the          optimal treatment setting with regard to these aims.      The medication is injectable pure heroin (diacetylmorphine) 3x/d, or d l methadone 1x/d      The study design is multicentre, open, randomised, 4 x 2 stratified. The study duration is 24     months (individual period of investigation), 1. study phase: 12 moths (protocol part B) and     2. study phase: 12 moths (part C). Patients recruited have an opiate dependency according to     ICD-10, who are not being treated currently or who are in a methadone maintenance programme     with an unsatisfactory course of treatment.   "
185146|NCT00260182|"     This study will identify specific genes that may cause a predisposition to depression in some     families.   "
185067|NCT00268580|"     The purpose of the study is to evaluate whether the Emergency Department (ED) Asthma Care     Project (ACP) leads to improved asthma care delivery and patient outcomes in the ED setting.      Hypothesis: Implementation of a multi-disciplinary asthma strategy/clinical pathway for the     treatment of asthma in the ED, based upon the 1999 Canadian Asthma Consensus Guidelines (and     subsequent updates), will increase adherence with published management guidelines in the ED     setting, reduce variations in the emergency management of acute asthma, increase utilization     of specialized asthma services and improve outcomes for patients following ED visits.      Methods:      This observational, pre- post-intervention study will compare a stratified sample of 10     Ontario hospital EDs (5 intervention and 5 control sites). Chart abstractions will be     performed on all adult visits for acute asthma over a 3 month period before and after     implementation of the Ontario Hospital Associations (OHA)'s (now Ontario Lung Association's     (OLA's) ED Asthma Care Map. Patient and provider surveys and provider focus group post     intervention will also be conducted. Primary outcome measures are hospitalizations and repeat     ED visit rates. Secondary outcome measures include: length of stay in ED, self-reported     adherence with referral to specialized asthma services made during index ED visit,     self-reported asthma control, and use of self-management strategies (including use of action     plan), use of asthma management strategies promoted by the care map (such as use of objective     measure of airflow rates, use of steroids, education, referral to specialized asthma services     on discharge). Ease of implementation and barriers to implementation will also be evaluated.   "
185068|NCT00268593|"     Docetaxel (Taxotere) is an approved chemotherapeutic drug for the treatment of     androgen-independent prostate cancer. The aim of the study is to investigate whether addition     of the investigational drug PI-88 will increase the efficacy of docetaxel in this disease.     PI-88 inhibits cancer growth by inhibiting the development of new blood vessels and starving     the tumour of oxygen and nutrients (anti-angiogenic). Because PI-88 and docetaxel have     different mechanisms of action, they are expected to have increased (synergistic) activity     when combined.   "
185069|NCT00268606|"     The present study is a new approach of examining tailored cognitive-behavioral interventions     for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with     respect to cognitive-behavioral risk factors and these patients are offered tailored     cognitive-behavioral treatment options. It is expected that this approach will result in     increased magnitude and maintenance of effects.   "
185070|NCT00268619|"     Study objectives:        -  To demonstrate that the acute administration of ramipril will control the inflammation          process in patients with high-risk Acute Coronary Syndrome (ACS) as assessed by the high          sensitivity C-reactive protein blood levels.        -  To demonstrate that the normalization of blood glucose levels with intravenous insulin          will improve the inflammation process during the acute phase of an ACS as assessed by          Tumor necrosis factor alpha blood levels.   "
185071|NCT00268632|"     The primary objective of this study is to assess the impact of physician's reinforcement     using bone marker data on the subject's compliance (at least 50% drug taken) and persistence     on treatment after one year in postmenopausal osteoporotic women.   "
185072|NCT00268645|"     The aim of this project is to confirm the efficacy and safety profile of Insulin glargine in     daily practice and to improve the physicians' knowledge and experience concerning Insulin     glargine   "
185073|NCT00268658|"     The purpose of this study is to evaluate the effectiveness of the biofeedback gait training     device in improving load bearing over an operated limb, during post-operative gait training     therapy. The effectiveness of the device will also be tested in self-training at home.   "
185074|NCT00268671|"     Study Objectives:        -  To determine the MTD (maximal tolerated dose) and recommended dose of a weekly docetaxel          and cisplatin combination regimen for locoregional recurrent/metastatic Squamous Cell          Carcinoma of the Head and Neck (SCCHN)        -  To determine the response rate of the recommended dose        -  To determine the safety and tolerability of the recommended dose   "
185075|NCT00268684|"     The objectives of the study is to determine if either temozolomide or erlotinib combined with     WBRT and SRS improves survival as compared to WBRT and SRS alone.Ptients with histologically     confirmed NSCLC with the presence of 1-3 intraparenchymal brain metastases will be randomized     to 3 arms. All of the patients will receive WBRT and SRS. The patients of the arm 1 will     receive radiation treatment only, the arm 2 patients will be treated with temozolomide and     arm 3 patients will receive erlotinib   "
185076|NCT00268697|"     The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily     (QD), taken with ezetimibe on cholesterol levels in subjects with primary dyslipidemia   "
185077|NCT00268710|"     Primary objectives:        -  To determine the response rate, measurable and non measurable, to Taxotere® in the          second line setting.      Secondary objectives:        -  To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as          second line therapy in HRPC        -  To evaluate PSA response (PSA: Prostate Specific Antigen)        -  To evaluate symptomatic response        -  To evaluate Quality of life        -  To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.   "
185078|NCT00268723|"     To determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be     effective in the prevention of EIB and be safe and well-tolerated.   "
185079|NCT00268749|"     This is an open label trial of the NMDA agonist glycine used alone for symptoms that appear     to be prodromal for schizophrenia in adolescents and young adults.   "
185084|NCT00268827|"     The purpose of this study is to compare Kaletra tablets with Kaletra soft-gel capsules to see     if there is any change in the side effects you may have and to see how people in the study     feel about using the tablets.   "
185085|NCT00268840|"     The purpose of this study is to assess the efficacy of combination therapy with gemcitabine     and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary     adenocarcinoma.   "
185086|NCT00268853|"     The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide,     Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting     Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.   "
185087|NCT00268866|"     Danish Quality Assurance Project on Diagnosis and Treatment of COPD in Outpatient Lung     Clinics   "
185093|NCT00268944|"     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the     body's cells to break down glycogen (a stored form of sugar) within specialized structures     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates     and is stored in various tissues, especially heart and skeletal muscle, which prevents their     normal function. The overall objective is to evaluate the safety and efficacy of rhGAA in     patients with advanced Late-onset Pompe disease.   "
185094|NCT00268957|"     Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered     into this study at approximately 26 centers in the United States. This study aims to evaluate     the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest     meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals.     The total length of participation is approximately 24 weeks.   "
185095|NCT00268970|"     The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel     in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).   "
185096|NCT00268983|"     Comparison of rituximab versus Iodine I 131 Tositumomab Therapeutic Regimen (Tositumomab and     Iodine I 131 Tositumomab or the Bexxar Therapeutic Regimen, formerly called Iodine-131     Anti-B1 Antibody) in subjects with follicular non Hodgkins B cell lymphoma. 506 subjects will     be enrolled at 30 to 40 sites in the US, Canada, and Europe. Subjects will be randomly     assigned to one of two treatment arms. In Arm A, subjects will receive 375 milligrams/meter2     (mg/m2 )of rituximab, given as an intravenous (IV) infusion once weekly for 4 weeks. In Arm     B, subjects will undergo a two-phase treatment. In the first phase, termed the dosimetric     dose, subjects will receive an infusion of unlabeled Tositumomab (450 mg) immediately     followed by an infusion of 5 millicuries (mCi) (0.18 gigabecquerel [GBq]) of Iodine 131     Tositumomab (35 mg). Whole body gamma camera scans will be obtained three times (Day 0; Day     2, 3, or 4; and Day 6 or 7) following the dosimetric dose. The information derived from the     scans will enable a patient specific dose to be calculated to deliver the desired total body     dose of radiation (65 or 75 centigray [cGy]). In the second phase, termed the therapeutic     dose, subjects in Arm B will receive an infusion of unlabeled Tositumomab (450 mg)     immediately followed by an infusion of the subject specific activity of Iodine 131-conjugated     Tositumomab (35 mg). Thyroid blockade will be implemented 24 hours prior to the dosimetric     dose and continued for 14 days following the therapeutic dose. Subjects on study will be     followed for response and safety at Week 7, Week 13, and every three months for the first and     second year, every six months for the third year, and then annually for the forth and fifth     years; and then for vital status, additional therapy, and long term safety events through     year ten. Follow Up after subsequent NHL therapy will be carried out to assess tolerance of     next anti-lymphoma therapy, development of myelodysplasia (MDS)/acute myelogenous leukemia     (AML), HAMA or hypothyroidism, unexpected safety issues, and death.   "
185097|NCT00268996|"     IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented     coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers,     safety and tolerability.   "
185098|NCT00269009|"     The investigators want to find out if providing a Community Health Educator Referral Liaison     (CHERL) helps practices help their patients change risky behaviors (tobacco use, physical     inactivity, unhealthy diet, and risky drinking) by connecting patients to available services     in the community or directly providing behavior change support.   "
185156|NCT00260312|"     The purpose of this study was to evaluated the effectiveness of inactivated poliovirus     vaccine at a vaccine schedule that is commonly used in developing countries. The     effectiveness of inactivated poliovaccine given at this schedule is important to national     policy makers as they consider vaccination policies after the use of oral polio vaccine is     discontinued.   "
185099|NCT00269022|"     Despite the success of the triptan class of drugs, approximately 60% of patients who take     medication at the moderate to severe pain stage of acute migraine, still have pain of mild or     greater degree at 2 hrs post dose. SB-705498 is a novel, first in class TRPV1 receptor     antagonist under development for the treatment of migraine pain. Preclinical experiments have     demonstrated that the TRPV1 receptor is expressed both centrally and peripherally in the     trigeminal system and inhibition of TRPV1 with SB-705498 can both prevent and reverse     established central sensitisation.   "
185100|NCT00269035|"     This study is being conducted in 2 groups of schizophrenic patients: in group 1 the     relationship between the dopaminergic D2 receptor occupancy (D2 RO ) and serotoninergic 5HT2A     receptor occupancy at stable plasma concentration (Cp) of SB-773812 will be investigated     using SPECT scan in up to 15 chronic schizophrenic patients in an open- label design. In     group 2 up to 80 patients will receive SB-773812 or Risperidone for 6 weeks to obtain at     least 10 patients showing clinical improvement with SB-773812. The relationship of D2 RO,     measured at steady state after chronic dosing at Cmax (6+/-2 h) and Ctrough (24+/-4 h), and     PK at steady state after repeated doses, to efficacy readouts will be investigated. The     SB-773812 dose administered will be selected as the highest dose proven to be safe and well     tolerated from a previous study.   "
185101|NCT00269048|"     This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or     CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma     Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated     with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of     SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to     double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will     then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once     daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs,     electrocardiograms, clinical laboratory safety tests and adverse event assessments will be     performed to evaluate the safety and tolerability of SB-480848.   "
185102|NCT00269061|"     This study will use Magnetic Resonance Imaging (MRI) techniques to evaluate changes in fluid     volume in the lower legs of diabetic patients who add either pioglitazone or placebo to their     current diabetic regimen.   "
185103|NCT00269074|"     Primary objectives: effect of IDEA-070 compared to placebo on pain and inflammation induced     by PDT. The primary objective is to detect a statistically significant difference of pain and     inflammation induced by PDT in test areas treated with IDEA-070 compared to placebo-treated     areas.   "
185104|NCT00269087|"     This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease).     This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects     will be given breathing tests, and will record their breathing symptoms daily on diary cards.   "
185105|NCT00269100|"     The purpose of this study is to analyse bacteremia induced by debridement of pressure ulcers     in patients in the complex nursing department.   "
185147|NCT00260195|"     This study will develop a program to help school children deal with violence-related trauma.   "
185106|NCT00269113|"     This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the     East German Study Group for Hematology and Oncology versus standard chemotherapy plus     MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and     mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target     sample size is 100-500 individuals.   "
185107|NCT00269126|"     This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary     Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times.     Subjects will be given breathing tests, and will record their breathing symptoms daily on     diary cards.   "
185108|NCT00269139|"     Dr. Laddis will test a hypothesis about the nature and the management of behavioral crises in     patients with borderline personality disorder (BPD) or post-traumatic stress disorder (PTSD).     The term behavioral crisis is used strictly for periods of uncontrollable urges to repeat     mental or outward activity, e.g., flashbacks, cutting, binging on food, drugs or sex, with no     intervals to rethink one's priorities or to consider others' direction.      The clinical hypothesis states, in two steps, that:        1. the perception of a life crisis precedes and then underlies every behavioral crisis;        2. the behavioral crisis resolves promptly and all symptoms end if the clinicians engage          the patient about his management of the life crisis that underlies the symptoms.   "
185109|NCT00269152|"     This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility     study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as     adjuvant combination-chemotherapy in participants with completely resected, stage Ib or     IIa/IIb non-small cell lung cancer (NSCLC).      A two-stage design will be employed independently for both treatment arms, with the     possibility of stopping each treatment early for lack of feasibility.   "
185110|NCT00269165|"     This study will examine the effect of external beam radiation therapy in the prevention of     restenosis following successful balloon aortic valvuloplasty in severe, symptomatic aortic     stenosis.   "
185111|NCT00269178|"     Health promotion in schools aims to improve the health and well being of students by     empowering them with the knowledge, skills and confidence to take responsibility for their     own health. We incorporated a malaria component to an established peer health education     programme in schools in The Gambia, and evaluated its impact on knowledge attitudes and     practice (KAP) of school students and their families using a cluster randomized design. Since     malaria is a particular problem among children under 5 and pregnant women, students were     encouraged to explain what they learned to their families, and we sought to evaluate whether     the malaria messages were taken up by the students' families. Evaluation endpoints are KAP in     students, and KAP in women living in the school students' home compound.   "
185112|NCT00269191|"     This study was conducted to assess the safety and tolerability of the drug and to evaluate     its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.   "
185113|NCT00269204|"     A 28-week clinical trial in patients with primary hypercholesterolemia or mixed     hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9     scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of     the 3 treatment groups.   "
185115|NCT00269230|"     People who have abnormal heart beats, or whose heart does not beat on its own, may need an     electronic device called a pacemaker or a defibrillator. Furthermore, people whose hearts     have a reduced pumping ability may need a device are called cardiac resynchronization therapy     (CRT) device. A CRT device is implanted surgically just under the skin in the upper chest     area. This device then helps the heart beat at a regular rhythm by sending electrical signals     (pacing) directly to the heart tissue through flexible wires called leads. The device may     also be able to stop the heart from beating too fast. Three leads are implanted into the     chambers of your heart. Two of the leads will be placed on the right side of your heart. The     third lead is placed on the left side of your heart and is the lead being studied.      The purpose of this study is to evaluate the safety and efficacy of the Attain StarFixTM     Model 4195 Left Ventricular (LV) Lead. This particular model lead has special characteristics     that may help to better keep it in position once it is implanted into the left ventricle. It     is also steroid-eluting which means that over time it slowly releases a small amount of     medication into the heart tissue to help prevent too much swelling around the area it is     implanted.   "
185116|NCT00269243|"     Angiotensin converting enzyme (ACE) inhibitors have been shown to improve survival and to     reduce the risk of cardiovascular events in some groups of patients following myocardial     infarction. This study is designed to test whether early initiation (≤7 days) of an ACE     inhibitor post-coronary artery bypass graft (CABG), would reduce cardiovascular events. The     trial was a double-blind, placebo controlled study of 2,553 patients randomly assigned to     quinapril, target dose 40 mg daily or placebo, followed up to 43 months.   "
185117|NCT00269256|"     The purpose of this study is to evaluate the multiple mechanisms through which stress,     physical environment, and genetic predisposition contribute to asthma in urban children.   "
185118|NCT00269269|"     To compare the unconditioned and conditioned effects of placebo capsules in the treatment of     patients with borderline hypertension (BH).   "
185119|NCT00269282|"     The purpose of this study is to determine the effectiveness of two home-based asthma     interventions in increasing adherence to daily asthma controller medication.   "
185120|NCT00269295|"     The purpose of this research study is to determine whether a new vaccine for typhoid fever is     safe and effective. This study will also look at what effects (good and bad) this new     vaccine, Ty800, has on the volunteers. The study will determine the highest dose of Ty800     that can be given without causing severe side effects. About 54 healthy males and females,     ages 18-45 inclusive, in the Cincinnati metropolitan area will be enrolled in this study.     They will be in the study for approximately 7 months, which includes a one month screening     period, study product administration on Day 0, a 10-day hospital stay, an outpatient period     on Days 9-28 with 4 follow-up visits, and safety follow-up phone calls at 2 and 6 months     after hospital discharge. Researchers hope that this trial will help produce a vaccine that     combines a high level of durable protective immunity with simplicity of administration and     minimal reaction to the vaccine.   "
186326|NCT00285376|"     This study is designed to determine the safety and effectiveness of vilazodone for major     depressive disorder and to discover genetic markers associated with response. This study will     enroll approximately 400 patients.   "
185121|NCT00269308|"     The purpose of this randomized clinical trial is to assess the relative effectiveness of     three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic     manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home     exercise alone.   "
185122|NCT00269321|"     The purpose of this randomized clincal trial is to assess the relative effectiveness of three     conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic     manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home     exercise alone.   "
185123|NCT00269334|"     The study includes two components：(1) cross-sectional (Study I), and (2) longitudinal     treatment trial (Study II). The cross-sectional component will include all subjects initially     recruited for the parent project. Genotyping characteristics will be compared with clinical     status (i.e., recovered vs symptomatic). The treatment trial component (one) will include a     subset of the subjects (n = 400) who remain significantly depressed. They will be randomly     assigned to 8-weeks of treatment with either citalopram or paroxetine. With such a design, we     wish to test the following hypotheses：      Ⅰ. Depressed patients with the short variant of the serotonin transporter (5HTTLPR) will     respond faster and better to antidepressants compared to their counterparts with the long     variant. Concurrently, patients with the 5-HTT Stin2 12/12 allele will also show better     response as compared to those with the 10/12 allele.      Ⅱ. Depressed patients who are homozygous for deficient or less active CYP2D6 or CYP2C19     enzyme(s) will be more likely to show treatment emergent side effects compared to subjects     with the wildtype alleles. Specifically, in Study II, CYP2D6 polymorphism will predict PAR     but not CIT side effects and CYP2C19 polymorphism will be associated with CIT but not PAR     side effects.   "
185124|NCT00269347|"     The broad, long term objective of this interdisciplinary research is to identify effective     therapies for low back pain sufferers and to increase our understanding of this important     condition. The primary aim is to examine the relative efficacy of chiropractic spinal     manipulation, rehabilitative exercise, and self-care education in terms of patient-rated     outcomes in the short and long term for non-acute low back pain.   "
185125|NCT00269360|"     The purpose of this study is to compare three treatments for neck pain: 1) rehabilitative     exercise, 2) chiropractic spinal manipulation combined with rehabilitative exercise, and 3)     self-care education.   "
185126|NCT00269373|"     Is PET-CT scan better than PET or CT alone in diagnosing primary tumours in patients with     unknown primary tumors? Can information obtained with PET-CT replace other clinical and     radiological investigations? Is PET/CT cost-effective?   "
185127|NCT00269386|"     Clarithromycin may be an effective therapy in Crohn's disease. It is a broad spectrum     antibiotic. Crohn's disease, the investigators think, is in some way related to bacteria,     which reside in the bowel.      Previous studies of different types of antibiotic in Crohn's disease have shown encouraging     results. Clarithromycin alters the bacteria in the bowel and gets into cells in the bowel     which may contain bacteria. There is some evidence that clarithromycin can stimulate the     immune system and improve the function of cells involved in killing bacteria in the bowel.   "
185128|NCT00269399|"     The purpose of this study is to assess the treatment and safety of a 10-day course of     rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium     difficile-associated diarrhea (CDAD).   "
185129|NCT00269412|"     This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects     will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550     mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an additional     two weeks of placebo for a total of 4 weeks of treatment. A fifth group of subjects will     receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully respond to     treatment at the end of the 28-day Treatment Phase will be followed in a Post-treatment Phase     that includes study visits during Weeks 6, 8, 12 and 16. Subjects who relapse during the     Post-treatment Phase will be discontinued from the study.   "
185130|NCT00269425|"     The purpose of this study is to determine whether a Mediterranean style diet, enriched in     monounsaturated and omega-3 fats, is superior to the American Heart Association Step 2 diet,     a traditional low fat diet, for improving rates of survival and cardiovascular complications     in persons who have had a first myocardial infarction (heart attack).   "
185131|NCT00269438|"     The purpose of this study is to establish the efficacy and safety of a new tablet formulation     and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical     improvement in subjects with mildly to moderately active ulcerative colitis after 8 weeks of     therapy.   "
185132|NCT00269451|"     Assessing the prevalence and natural course of PTSD after the 1999 Turkish earthquake   "
185133|NCT00269464|"     Evaluating the prevalence and characteristics of obsessive-compulsive (OC) symptoms in     patients with chronic schizophrenia   "
185134|NCT00269477|"     The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged     15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study     MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the     antibody response will be evaluated in a subset of these participants who will receive a     booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who     have not been previously vaccinated with a meningococcal vaccine or had documented meningitis     disease who will also receive a dose of Menactra® vaccine.   "
185148|NCT00260208|"     Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases     and over time causes fibrosis and eventually cirrhosis of the new liver. The aim of this     study was to see if the frequency of liver fibrosis was different with cyclosporine     microemulsion than tacrolimus   "
185149|NCT00260221|"     Using Virtual Reality Hypnosis to relief pain and anxiety for burn patients.   "
185174|NCT00260572|"     The aims of this study are to create a prospective data base to evaluate the long term     outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to     measure standard outcomes as well as patient derived outcomes such as general and disease     specific quality of life (QOL) issues and patient satisfaction; to refine the parameters that     may identify patients who will benefit from surgery for GERD; and to identify possible     determinants of failure of both medical and surgical treatments of reflux.   "
185135|NCT00269490|"     The purpose of the proposed research is to conduct a feasibility study of yoga as an     adjunctive therapy for the treatment of posttraumatic stress disorder (PTSD) in 15 military     personnel at the Walter Reed Army Medical Center (WRAMC) in Washington, DC. Participants will     complete 10 weeks of yoga training, in addition to the continuing their usual and customary     care for PTSD at WRAMC. The style of yoga chosen for this study, Yoga Nidra, uses deep     relaxation, deep breathing and meditation to systematically reduce physical, emotional,     mental, and even subconscious tension. After a diagnostic mental health assessment at     baseline, participants will attend a total of 18 classes taught over a 10-week period and     will practice daily at home using a compact disk provided by the instructor. Baseline     measures will include the Patient Health Questionnaire, PD-HAT Trauma Questions, PTSD Symptom     Scale - Interview, Fear of Loss of Vigilance Scale, and expectation of efficacy. The primary     outcome measure will be the PTSD Checklist. Changes in health status, locus of control, and     pain will be assessed over the course of the study. An additional goal of this study is to     gather preliminary data on the anticipated effect size and feasibility of conducting a larger     clinical study of the adjunctive use of yoga for the treatment of PTSD symptoms in enlisted     military personnel.   "
185136|NCT00269503|"     Back pain is a major cause of disability in the United States. The lifetime prevalence of low     back pain is estimated at 60-90%. Back pain has conservatively been estimated to involve     total direct and indirect costs of over $25 billion annually in lost wages, treatment, and     related issues. These losses clearly extend to the active duty population cared for by     military health care facilities.      Chiropractic medicine is characterized by the use of a number of physical manipulations and     mobilization techniques, which can be used singly or in combination to treat a variety of     medical conditions. Although basic clinical practice guidelines for Chiropractic have been     developed, few studies have rigorously compared techniques and their outcomes for specific     conditions. Fewer still have sought to correlate treatment modality with both anatomical     effect and clinical outcome.      Throughout the military, Chiropractic care is available only to active duty personnel and     only at a limited number of medical treatment facilities. At National Naval Medical Center,     it is a well-established treatment option, where the full array of techniques is employed,     primarily for painful conditions, and most often for back pain. This study seeks to clarify     the mechanisms of action and efficacy of one specific treatment option, prone distraction,     for the relief of subacute sciatica due to radiographically confirmed herniated disc, and to     compare it to side-posture manipulation and standard medical management.      Prone lumbar distraction utilizes a specialized table with motorized continual motion     distraction. This table has multiple mechanical articulations that can be used to place     patients in a wide variety of positions. Patients being treated with continuous motion     distraction are placed prone with the table positioned for maximum comfort and centralization     of symptoms.      Side posture manipulation is a widely practiced, standard chiropractic technique, which has     been shown to provide considerable clinical improvement for patients with sciatica. Low-     grade oscillatory stresses are performed within the physiological range of normal joint     motion. The hip, pelvis and lumbar spine are rotated forward with manual pressure while a     counter rotation of the chest and thoracic spine is applied.   "
185137|NCT00269516|"     This study is a multicenter, randomized, double blind, parallel group study of 6 months'     treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open     label safety extension to this study is planned as a separate protocol for patients who are     willing and eligible to participate.   "
185138|NCT00269529|"     The study aims to compare two different kinds of pain treatment after total knee replacement     (operation with artificial knee joint): 1) a large local injection in and around the knee,     supplemented with injection the day after, or 2) the department's conventional pain treatment     consisting of continuous nerve block in the groin.   "
185139|NCT00269542|"     Children, aged 1 months to 23 months, in the intervention households received zinc, iron and     folic acid and those in the control households were administered iron and folic acid (IFA)     alone for a period of one year. The primary outcomes were hospitalizations and deaths during     this period.   "
185140|NCT00269555|"     Genistein Combined Polysaccharide (GCP) is derived from adding soy powder to shiitake     mushrooms. This concentrated mixture is currently being sold in Japan and the United States     and is thought to possibly contain properties that may be useful in treating certain types of     cancer.   "
185157|NCT00260325|"     Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to     injury could reduce or prevent the development of secondary hyperalgesia around the area of     primary injury. A heat/capsaicin model of induced hyperalgesia was tested in healthy     volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg     vadecoxib versus control. Subjects rated pain intesnsity and unpleasantness following heat     stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the     experiment.   "
185141|NCT00269568|"     This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an     intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate     in this prospective clinical trial. This study will provide an evaluation of oral     mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up     to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7     and 14 days after misoprostol administration, when using mifepristone 200 mg orally and     misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up     to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as     acceptability will be done using pre and post-study questionnaires, and visual analogue     scales. Complete abortion rate within 24 hours is expected to be 90%   "
185142|NCT00269581|"     Purpose of this study is to determine if a CD-ROM computer program (called Headstrong) is     effective in helping children cope with chronic headaches.   "
185143|NCT00260143|"     Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though     they may try to eat more food to gain weight. The reasons for this weight loss are not clear.     Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone     that is naturally produced in the bodies of both men and women and has important effects on     building muscle and bone mass. The purpose of this study is to find out if providing     additional testosterone to HIV infected men who have low testosterone can help them gain     weight, increase their muscle mass, and feel better. The study will also help see if     testosterone improves the efficiency with which your body produces and uses energy including     fat. The dose of testosterone being used in this study will raise testosterone levels in the     blood to higher than normal levels (2-3 times normal level).   "
185144|NCT00260156|"     This study is not being conducted in the United States. The purpose of this study is to     assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic     islet function in people with type 2 diabetes who have not previously been treated with drug     therapy to lower their blood sugar.   "
185145|NCT00260169|"     This study will determine ways to make depression care more responsive to the needs of     consumers in primary care clinics serving low-income Latinos.   "
185150|NCT00260234|"     Insulin dependent Type I diabetics require daily insulin therapy to normalize blood glucose     but may have difficulty with significant glycemic excursions and hypoglycemic episodes and     crises. Islet cell transplantation can provide relief from daily insulin therapy, normalize     blood glucose and reduce or eliminate short and long-term diabetes-related complications.     PEG-Encapsulated Islet Allografts is a new islet transplant product under development that     does not require the ongoing use of immunosuppressive drugs after the implant. This study     will test the safety and efficacy of PEG-Encapsulated Islet Allografts in the treatment of     Type I diabetes and provide functional outcome measurements.   "
185151|NCT00260247|"     This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that     metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of     these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical     observations suggest that oxcarbazepine does not induce these enzymes to the same degree.      This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4     enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme     activity.      It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.   "
185152|NCT00260260|"     Patients undergoing surgery (thyroidectomy and hysterectomy) will postoperatively receive     oxycodone intravenously (IV) as pain management with morphine as an escape medicine, if there     is insufficient pain relief with oxycodone. Patients' pain and side effects will be     registered and after 24 hours they will answer a questionnaire. All included patients will be     genotyped accordingly to CYP2D6 and relevant single nucleotide polymorphisms (SNPs), and     measures of plasma levels of oxycodone will be performed.   "
185153|NCT00260273|"     Schizophrenia is one of society's most costly medical conditions and the most severe among     psychiatric disorders. One of the most important and exciting new concepts in psychiatry is     that detection and intervention very early in the course of schizophrenia offers what may be     the field's best practical hope for realizing substantive improvements in the outcome of     schizophrenia or schizophrenia spectrum disorders. Thus, we propose a five year program that     focuses on three interconnected major research streams: (1) an evaluation of the     effectiveness and cost-effectiveness of a model-driven psychological intervention in     preventing or delaying the onset of a psychotic illness; (2) a qualitative study of the     pathways to mental health at this time of very high risk; and (3) an exploration of the     burden to the healthcare and informal caregiver systems associated with this high risk     population.   "
185154|NCT00260286|"     The purpose of this experiment is to investigate whether the dependence of luteinizing     hormone pulsatility on energy availability declines during adolescence.   "
185155|NCT00260299|"     Participants wanted for study of mevalonate kinase deficiency (MKD), mevalonic aciduria, or     hyperimmunoglobulinemia with periodic fever syndrome (HIDS).      Patients with MKD (mevalonic aciduria or hyperimmunoglobulinemia with periodic fever syndrome     (HIDS)) may be eligible for a research study conducted at Oregon Health & Science University     (OHSU) in Portland, Oregon USA. The purpose of the study is to find out more about how these     diseases affect body chemistry and health. The researchers also want to find out how     cholesterol in the diet affect blood cholesterol and how the body handles cholesterol. This     is a short-term and long-term dietary study. The long-term goal of this research is to see if     controlling dietary cholesterol can decrease any of the symptoms of the diseases.      The study could involve up to 12 one-week admissions to OHSU over the course of 5 years.   "
185158|NCT00260338|"     Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into     endothelial cells and participate in the development of new blood vessels in ischemic tissue.      The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical     effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial     ischemia.   "
185159|NCT00260351|"     -  To demonstrate that rabies vaccine administered according to the Thai Red Cross,          (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according          to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects          with a WHO category III rabies exposure,or,        -  To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen          (2-1-1) is not inferior to Rabies vaccine administered according to the ESSEN IM regimen          in terms of GMTs at D28, in subjects with a WHO category III rabies exposure.      Secondary objectives:        1. To describe the immunogenicity profile of each regimen        2. To assess the safety of the vaccine in each group.   "
185160|NCT00260364|"     Pancreatic cancer is an aggressive, largely chemo-resistant disease with a poor prognosis.     EGFR and VEGF are both overexpressed in pancreatic cancers and thought to contribute to     tumour development and progression. The combination of gemcitabine and capecitabine has     recently been shown to be effective in advanced pancreatic cancer. The combination of     gemcitabine plus erlotinib has also been shown to be effective in advanced pancreatic cancer.     The aim of this study is to assess whether combining a chemotherapy doublet (gemcitabine plus     capecitabine) and a biologic doublet (erlotinib plus bevacizumab) is a safe and effective way     to treat advanced pancreatic cancer by targeting multiple tumour stimulating mechanisms     simultaneously.   "
185161|NCT00260377|"     Aspirin was proved to be the drug preventing vein grafts from closure and improving clinical     outcome after coronary artery bypass surgery. It appears to be effective when being     prescribed as early as first 48 hr. after the operation without increasing the incidence of     bleeding complications. the exact effective dose is not known.   "
185162|NCT00260390|"     Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men     may be associated with age-related HPG hypofunctioning. In this study we seek to examine the     efficacy of Testosterone replacement for this condition.      Hypothesis:      Testosterone replacement will be more effective than placebo, in treating men with late onset     Dysthymic Disorder and hypo-gonadism.   "
185173|NCT00260559|"     To assess short and long term outcomes after minimally invasive esophagectomy compared to     open esophagectomy. To compare both standard outcome measures as well as patient derived     outcome measures, in particular, quality of life (QOL). To look at the applicability of this     QOL instrument to this patient group.   "
185186|NCT00260728|"     The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of     the Fusion™ Vascular Access Graft for patients in need of early vascular access for     hemodialysis.   "
185163|NCT00260403|"     The purpose of the study is to compare photodynamic therapy to transpupillary thermotherapy     as a treatment method for choroidal neovascularization in age-related macular degeneration (     AMD). AMD is a disease affecting the macula, the central area of the retina.There are two     main types of AMD. Geographic atrophy ( dry) AMD and neovascular ( wet) AMD. In neovascular     AMD, sub-retinal neovascular membranes ( new blood vessels) develop beneath the retina. The     new vessels can leak causing haemorrhage that leads to significant visual loss. Photodynamic     therapy ( PDT) is a method for treating neovascular membranes without affecting the retina.     Photoactive chemicals are injected into the patient and irradiated with light as the pass     through the neovascular membranes. This light is strong enough to activate the chemicals,     that destroy the blood vessels, but not strong enough to cause damage to the overlying     retina. The duration of the treatment is 83s. PDT treatment is effective in predominantly     classic subfoveal choroidal neovascularization ( CNV), but was observed to yield no visual     benefit in minimally classic CNV during a 2-year follow-up and as to occult CNV the effect     was scarce. PDT does have its drawbacks, one of which is the cost. Another is that the     patient become highly sensitive to strong light. Transpupillary thermotherapy ( TTT) is a     thermic treatment of choroidal neovascularization in AMD. Using a thermal diode laser (     emission 810 nm), transpupillary irradiation of the fundus through a conventinal contact lens     is performed. The temperature is elevated < 10 degrees C during a 60s exposure to continuous     radiation. The laser power is adjusted to the diameter of the laser beam. In a pilot study,     Reichel et al. ( 1999) demonstrated that subfoveal occult CNV could be occluded and visual     acuity stabilized in a majority of patients treated with TTT. These results has been     confirmed in small series of cases with occult CNV and with minimally ( <50%) classic CNV.     This prospective, randomized controlled study aim to compare TTT and PDT as a treatment for     occult and minimally classic CNV. A total of 140 patients will be included in the study.     Follow up is 2 years. The patients included will be followed as to visual acutiy ( ETDRS),     new vessel growth ( fluorescien angiography and ICG), OCT and with a quality of life     questionnarie.   "
185164|NCT00260416|"     Background: Acute balloon angioplasty is beneficial in patients with acute myocardial     infarction. However, presently this treatment is not offered to patients with symptom     duration above 12 hours.      Hypothesis: Acute balloon angioplasty for myocardial infarction is beneficial despite symptom     duration above 12 hours.      Methods: In 60 patients with myocardial infarction and symptom duration above 12 hours, the     proportion of non-perfused myocardium before acute angioplasty and 1 month after angioplasty     is compared to evaluate if myocardial tissue can be saved by acute angioplasty despite long     symptom duration.   "
185165|NCT00260429|"     The purpose of the study is to determine if collagenase will reduce the degree of contracture     in the primary joint in subjects with Dupuytren's disease.      This study was designed to be part of the larger clinical program, for adult patients with     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal     Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were     evaluated.   "
185166|NCT00260442|"     The purpose of this study is to examine the effect of dietary cholesterol administered as     whole egg or egg white (control)on muscle mass gain with resistance training in a young old     population of men and women (age 50-69). It is hypothesized that dietary cholesterol will be     significantly associated to muscle mass gain.   "
185167|NCT00260468|"     The objective of this project is to examine the state of the brain in people over 50 years     old suffering from late-onset depression by means of an extensive clinical assessment     programme, including magnetic resonance imaging (MRI), neuropsychological testing,     neurological examination, eye examination as well as blood and saliva samples. The results     are to be compared with results from a control group matched for gender and age.   "
185168|NCT00260481|"     The purpose of this study is to assess the efficacy of the PROMETA pharmacotherapy compared     to placebo for initiating abstinence and for preventing relapse to methamphetamine use in     treatment-seeking individuals meeting criteria for methamphetamine abuse. It is hypothesized     that individuals assigned to receive the PROMETA pharmacotherapy, compared to placebo, will     demonstrate significantly fewer and less intense withdrawal symptoms, more days abstinent     from methamphetamine use, and fewer relapses to methamphetamine use as assessed by     self-report of drug use verified by urine samples.   "
185181|NCT00260663|"     This study compares the effectiveness of hearing aid appointments provided in a group format     to those provided in an individual format. We are asking if hearing aid training with group     appointments is as good as or better than with individual appointments.   "
185235|NCT00261378|"     The objective of this study is to assess the safety and efficacy of DC Bead™ delivered by     intra-arterial embolisation for the treatment of Hepatocellular Carcinoma   "
185169|NCT00260494|"     The purpose of this study is to determine if acupuncture improves wound healing. Since we,     the investigators at the University of California, San Francisco (UCSF), know that how much     oxygen is delivered to tissue is the best predictor of how well a wound will heal, we are     measuring changes in tissue oxygen of wounds before and after acupuncture treatments. We are     focusing on the leg wounds of coronary artery bypass graft (CABG) patients who have their     saphenous veins harvested in an open fashion since this is a fairly well controlled patient     model.   "
185170|NCT00260520|"     The objective of this trial will be to determine whether prophylactic low-molecular weight     heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A     prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe     fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal     growth restriction, or both.   "
185171|NCT00260533|"     The purpose of this study is to determine the effectiveness and tolerability of atomoxetine     (Strattera) in adult patients with generalized social anxiety disorder (an anxiety disorder     characterized by a fear of interpersonal interactions).   "
185172|NCT00260546|"     Cardiac resynchronisation therapy (CRT) is a highly effective treatment option for patients     with symptomatic heart failure and electrical intraventricular dyssynchrony, who are     unresponsive to medical therapy. CRT has been shown to improve the quality of life in these     patients and lately two studies had shown a mortality reduction with and without the adjunct     of an implantable cardioverter defibrillator (ICD). Unfortunately, up to 25% of the CRT     recipients do not show a symptomatic improvement after device implantation (non-responder).     Because of possible intermittent tachycardiac intrinsic conduction, it remains difficult in     numerous patients to assure a 100% biventricular stimulation as the prerequisite for a     beneficial therapeutic effect. In a important study by Knight et al it could be shown that in     a population of 440 CRT-patients, 36% did not have continuous biventricular stimulation. The     main cause was the occurrence of atrial tachyarrhythmias, in particular atrial fibrillation.     The medical control of rapid ventricular conduction remains a difficult problem in heart     failure patients. Furthermore it is unknown how many patients have good biventricular pacing     under resting conditions but develop an improved AV-conduction with exercise. This can cause     inhibition of ventricular stimulation or in many cases fusion beats. Conversely, an     AV-interval programmed too short may have detrimental effects on diastolic filling times.      The safest method to control the ventricular rate and prevent ventricular fusion beats with a     normal AV time is the AV node ablation using radiofrequency ablation.      The An Art Study investigates whether patients with an implanted CRT pacemaker or a CRT     defibrillator will benefit from an AV-node-ablation using a combined symptomatic heart     failure endpoint and duration of biventricular stimulation as compared to a CRT control     group.   "
185228|NCT00261287|"     The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal     spray for long term use in relieving symptoms in perennial allergic rhinitis.   "
185175|NCT00260585|"     The purpose of this study is to identify markers in the blood and tissue that could indicate     risk factors for the development and progression of esophagus cancer. This research aims to     collect medical history, blood, and tissue samples from patients who present with an     esophageal disorder. Identifying genetic and behavioral risk factors involved in the     development of esophageal cancer might allow for early detection and prevention. Survival and     an opportunity for a cure with esophageal cancer will depend greatly on the stage of     diagnosis. Tumors can develop changes in their genetic (hereditary) make-up, and these     changes can sometimes be seen in normal tissues before the development of cancer. These     genetic (hereditary) changes can serve as tumor markers and can be detected using methods     that study changes in genetic material like DNA and RNA. The analysis of proteins can provide     additional information. By identifying changes in these molecules that are different or     altered in cancer, the investigators can use methods and tests for the detection of these     changes.   "
185176|NCT00260598|"     The purpose of the study is to evaluate the usefulness and accuracy of the LIFE-Lung     Bronchoscopy to identify early changes in lung tissues that show precancerous, cancer in     situ (just beginning and not spread) and microscopic invasive cancer lesions versus the     ability of the standard White Light Bronchoscopy to identify the same. This will be done as     a part of routine monitoring bronchoscopy.      Patients who have had a surgical resection of non-small cell lung cancer (NSCLC) and with no     current evidence of disease (NED) will be eligible. Also eligible are patients who have had     head or neck squamous cell carcinoma with radical head and/or neck dissection and who are     currently NED. Patients with severe chronic, obstructive, pulmonary disease shown by     pulmonary function testing abnormalities will also be eligible.      In addition to the specialized bronchoscopy, doctors will be investigating the use of imaging     spectroscopy. This is using an optical (visualizing) procedure to measure the light reflected     back from tissue. Different lesions and normal tissues reflect light differently and in     specific color wavelengths. By using measurements over time (different     examinations/bronchoscopies) very small changes can be seen. This may allow eventually for     very early diagnosing of precancerous or cancer in situ lesions, allowing for earlier     treatment.   "
185177|NCT00260611|"     The primary objective for this study is to evaluate PSA response rates (response will be     defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy. The     secondary objectives are to compare progression free survival, disease free survival, overall     survival, and toxicity (tolerance/safety).   "
185178|NCT00260624|"     The purpose of this study is to determine the safety and efficacy of escitalopram (Lexapro)     using 10 or 20 mg daily in patients with Alzheimer's disease who are also experiencing     agitation.   "
185179|NCT00260637|"     Limited evidence suggests that acupuncture may help relieve symptoms of chronic     prostatitis/chronic pelvic pain syndrome. This study evaluated if acupuncture twice weekly     for 10 weeks would help ameliorate symptoms of CP/CPPS.   "
185180|NCT00260650|"     The purpose of this study was to determine the efficacy of a self-management program, called     the Heart PACT Program, compared to usual health care in patients with heart failure.     Outcomes measured were patient activation (skills needed to maintain function, collaborate     with providers, and access care), self-care management, hospitalizations and emergency     department visits.   "
185183|NCT00260689|"     Severe aplastic anemia (SAA) is a life-threatening bone marrow failure disorder characterized     by pancytopenia and a hypocellular bone marrow. Allogeneic bone marrow transplantation offers     the opportunity for cure in 70% of patients, but most patients are not suitable candidates     for hematopoietic stem cell transplantation (HSCT) due to advanced age or lack of a     histocompatible donor. For these patients, comparable long term survival is attainable with     immunosuppressive treatment with anti-thymocyte globulin (ATG) and cyclosporine (CsA).     However, of those patients treated with horse ATG(h-ATG)/CsA, one quarter to one third will     not respond, and about 50% of responders relapse. Auto-reactive T cells may be resistant to     the effect of ATG/CsA (non-responders), while in others residual auto-reactive T cells expand     post-treatment, leading to hematopoietic stem cell destruction and recurrent pancytopenia     (relapse). As long term survival is correlated to response rates and robustness of     hematopoietic recovery, novel immunosuppressive regimens that can achieve hematologic     response and decrease relapse rates are needed.      This trial will compare the effectiveness of three immunosuppressive regimens as first line     therapies in patients with SAA with early hematologic response as the primary endpoint, as     well as assess the role of extended CsA treatment after h-ATG in reducing numbers of late     events of relapse and clonal evolution. Randomization is employed to obtain an equal     distribution of subject to each arm; comparisons of early hematologic responses will be made     among the rates observed among the three concurrent arms (rabbit-ATG [r-ATG] versus standard     h-ATG; alemtuzumab vs standard h-ATG). For long course CSA, comparison of primary end points     will be to well established historic relapse rate of 38% at 2-3 years and a cumulative rate     of clonal evolution of 15%.   "
185184|NCT00260702|"     This study will evaluate the safety and effectiveness of a laboratory-made antibody called     omalizumab in patients with Job's syndrome, or hyper-IgE syndrome (HIES). Patients with HIES     have very high levels of IgE antibody, a protein made by white blood cells. IgE plays an     important role in starting allergic reactions in the body and may be related to some HIES     symptoms, such as skin rashes and asthma. Patients also have frequent lung infections, easily     broken bones and other symptoms. Omalizumab, which is approved to treat allergic asthma, is     directed against IgE. This study will see if blocking IgE with omalizumab in HIES patients is     safe and if it can reduce patients' IgE count. It will also look at how the body handles     omalizumab and how it affects patients' symptoms.      Patients 6 years of age or older with HIES may be eligible for this study. Each candidate is     screened with a medical history, physical examination, skin examination and blood test.      Participants receive an injection of omalizumab under the skin once every 2 weeks for 6     doses. At the time of each injection, patients are examined by a doctor, answer questions     about their symptoms and have a blood sample drawn. After the sixth dose, patients have a     physical examination, blood tests, skin examination and lung function tests. At follow-up     visits scheduled 2, 4 and 6 months after the last dose of omalizumab, patients have a     physical examination, answer questions about their symptoms, and have a blood sample drawn.     Patients who show a significant response to omalizumab stay off the drug for 3 months after     the last dose and then discuss with their study doctor and referring doctor about continuing     the medicine.   "
185185|NCT00260715|"     After exposure to the C-POL intervention: 1) unprotected vaginal or anal sex, sex with casual     partners, concurrent sexual relationships, and exchange of sex for drugs or money will     decrease significantly; 2) perceived syphilis-risk for self and peer group, knowledge about     highly relevant risk-factors, information sources and resources will increase significantly;     and 3) syphilis morbidity will decrease significantly in the intervention community as     compared to the comparison community.   "
185187|NCT00260741|"     The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral     cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe     and effective in reducing the symptoms of spasticity and tremor in patients with     secondary-progressive or primary progressive multiple sclerosis.   "
185188|NCT00260754|"     Community members within the treatment city will report: 1)engaging in fewer sexual risk     practices; 2)significantly higher condom use; 3) significantly higher rates of STD care     seeking (including STD screening behaviors); 4) fewer having STDs in the past 6 months; 5)     significantly higher awareness scores regarding syphilis and other STDs, as compared with     those in the comparison city.   "
185189|NCT00260767|"     This study will assess the distribution of topical gel in the human vagina, using enhanced     MRI techniques. The number and size of uncovered areas will be studied, and the upper genital     tract will be examined for the presence of topical gel using MRI.   "
185190|NCT00260780|"     Study participants who are exposed to the intervention will: 1)report more condom use during     sexual episodes; 2) have fewer new and repeat STD infections 3)demonstrate greater risk     reduction, communication, and anger management skills; 4) report fewer substance use     behaviors, and 5)report more health care seeking activities, than the participants in the     control group   "
185191|NCT00260793|"     The purpose of this research study is to see if subjects with Parkinson's disease who are     experiencing motor fluctuations (on and off states) and dyskinesias (involuntary     excessive movements) would benefit from a higher dose of Requip as compared to the maximum     FDA approved dose of dopamine agonist drugs (including Requip, Mirapex, and Permax). Requip     as used in this study is investigational, which means it has not been approved by the US Food     and Drug Administration (FDA) at this dose level.   "
185192|NCT00260806|"     This study will use the NIH-sponsored Women and Infants Transmission Study (WITS) and the     Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection     (P2C2) HIV-infected pediatric cohorts to determine how left ventricular (LV) function     (particularly fractional shortening and contractility) and structure (particularly wall     thickness and mass) are affected by cumulative intensity of exposure to highly active     anti-retroviral therapy (HAART).   "
185193|NCT00260819|"     Excessive rise in pulmonary artery pressure induced by low oxygen tension (hypoxia) is one of     the factors implicated in high-altitude pulmonary oedema. Plasma ET1 increases in subjects     exposed to high altitude and is correlated to pulmonary artery pressure.      The aim of the study is to investigate whether blockade of ET1 receptors would reduce the     acute rise in systolic pulmonary artery pressure induced by hypoxia.   "
185194|NCT00260832|"     The purpose of this study is to compare the results in older patients who have newly     diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine     or patient's choice with the physician's advice of either cytarabine or supportive care     medication.   "
185195|NCT00260858|"     The purpose of this study is to assess the extent of and sources of variation in the     glycaemic index values of foods measured by different laboratories around the world.   "
185196|NCT00260871|"     Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and     environmental factors. In this grant proposal, we propose to map the loci of susceptibility     genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. We focus     on a unique pathological type of a unique population in order to reduce heterogeneity of the     genetic background. Compared with western women, female Chinese population has a high     prevalence of lung adenocarcinoma. Our reasoning is that if we focus on a specific sub-type,     which has a familial basis, we will increase the probability of identifying genes associated     with female lung adenocarcinoma. The primary goal of this study is to identify the genetic     and environmental determinants of female lung adenocarcinoma, and study the relationship     between gene polymorphisms and clinical manifestation profiling of lung cancer.   "
185197|NCT00260884|"     -  OBJECTIVES To determine in a prospective randomized clinical trial, the effect of          extended lymph node dissection (R3 gastrectomy) versus conventional surgery (R0/1          gastrectomy) on tumor recurrence and survival in Chinese patients with advanced cancer          of the stomach (adenocarcinoma invasion beyond submucosa).        -  STATISTICAL CONSIDERATIONS The major end points are disease free survival and survival.          The log-rank test will be used as analytic method on disease-free survival and overall          durvival. The follow-up time after treatment is five years.      Previous experience provides an estimation of a 20% 5-year survival rate with conventional     surgery for gastric cancer. Assuming that this new treatment (radical surgery) may increase     the 5-year survival rate to 40%, we estimate that 118 evaluable patients are required to     detected a significance at a of 0.05 level and power of 0.8 using a one tailed test.      We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.   "
185198|NCT00260897|"     Avascular necrosis of the femoral head (ANFH) is a debilitating disease that commonly leads     to destruction of the hip joint in patients at middle age of life and often requires surgical     intervention. Previously, we have identified the collagen type II, alpha 1 (COL2A1) gene as     the ANFH disease gene. In this grant proposal, we will establish cell ine and animal models     to understand the pathophysiology of ANFH, and extend our ongoing study for identifying genes     responsible for non-familiar ANFH by looking into other interacting molecules of the pathway.   "
185199|NCT00260910|"     The purpose of this study is to determine the progression evaluation and genetic     determinations of hypertension in Chinese   "
185200|NCT00260923|"     This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and     300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in     the study for 8 weeks   "
185201|NCT00260936|"     To assess whether there exist significant differences in glucose metabolism, lipids, lactate,     body composition, and bone density between HIV-infected and uninfected young men.   "
185202|NCT00260949|"     There are two ways in which surgeons repair rotator cuff tears. An open method involves     making an incision (cut) 5-6 inches in length in the skin and repairing the tear with the     skin open, while the arthroscopic method involves making small holes in the skin and using a     guiding camera and special equipment to repair the tear. This clinical study is being     conducted to study the rate of re-tear (one year following surgery) of rotator cuffs that     have been repaired using the arthroscopic technique.   "
185203|NCT00260962|"     The purpose of the study is to evaluate the efficacy of an anti-psychotic medication,     Olanzapine, in achieving desired weight gain in patients identified as having Anorexia     Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible     beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety     symptoms associated with this disorder.   "
185204|NCT00260975|"     Many breast cancer patients treated with chemotherapy complain of problems with concentration     and memory. This has been referred to as chemo fog. The current study is investigating this     phenomenon by measuring patients' mental function prior to and after exposure to     chemotherapy, and by comparing mental function in those patients who receive chemotherapy and     those who do not.   "
185205|NCT00260988|"     The purpose of this study is to better understand if either dalteparin or tinzaparin is a     better drug to use in dialysis patients on blood thinners who are at high risk of developing     blood clots and need surgery.   "
185206|NCT00261001|"     The rationale for transcutaneous vaccination is based on the unique ability of cutaneous     immune cells, especially Langerhans cells (LCs), to present antigens to the immune system.     DCs can be found at high densities in the epidermis and the dermis of human skin, a fraction     of which are the epidermal LCs. It is known that strong and efficient immune responses can be     induced by targeting vaccines to skin APCs (Glenn 2003, Partidos 2003), e.g. by epicutaneous     application of smallpox vaccine on scarified skin. Several obstacles however prevent vaccines     from attaining sufficiently high and free concentrations in these target skin DCs.      In this clinical trial we aim at testing the safety and immunogenicity of this new     transcutaneous route of vaccine administration, first with a licensed, well-known, safe and     highly immunogenic vaccine i.e. Tetagrip® vaccine, which is licensed for subcutaneous (s.c.)     and intra-muscular routes (i.m), and to compare the induced vaccine-specific immune responses     to those induced with the conventional (i.m) injection. We hypothesize that the     transcutaneous application of Tetagrip® in the commercially available standard preparation of     0.5 ml should be capable to induce at least similar antibody and CD4 and/or CD8 T cell     responses to both the tetanus and the flu vaccinal antigens.      This Phase I, open label, randomized study is designed to evaluate and to compare the safety     and immunogenicity of a transcutaneous mode of Tetanus / Influenza vaccination to the     conventional i.m. route of vaccine administration in two cohorts: The cohort I constituted of     healthy volunteers and the cohort II of HIV-infected patients in whom the virus is stably     controlled by antiretroviral therapy, ensuring an immune competence and a capacity to respond     to vaccines.   "
185207|NCT00261014|"     The purpose of this study is to develop a way to predict which patients diagnosed with     idiopathic blood clots can safely stop warfarin therapy after six months. We will use patient     characteristics, blood test results and imaging test results to identify those patients who     have the lowest risk of developing a new blood clot after warfarin is stopped.   "
185284|NCT00262041|"     The purpose of this study is to evaluate the safety and immunogenicity of Novartis     Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide     vaccine administered to healthy adolescents ages 11 to 17 years.   "
185208|NCT00261027|"     This project is a pilot, phase II, open-label, single-center, non-comparative clinical study     evaluating the antitumor efficacy and tolerability of exemestane in treating adult     post-menopausal women with recurrent or refractory, stage II-IV, epithelial ovarian cancer.      To evaluate the efficacy and tolerability of exemestane in this population, patients will be     enrolled at a single site, namely the Ottawa Regional Cancer Center. Patients selected     according to the criteria outlined will receive exemestane (25 mg/day given orally once     daily) until disease progression or until study withdrawal. These patients will be treated on     an out-patient basis. There is no specific wash-out time required for patients who have     previously received either cis or carboplatinum; however, this previous therapy must stop     upon patient inclusion into this trial.      In 1st stage if less than 2/15 patients achieve a response then study will be terminated. In     2nd stage if greater than 7/28 patients achieve a response then no further investigation of     the drug is warranted.Treatment (including drug dosages) A commercial supply of exemestane     (Aromasin) will be provided. The medication will be administered by the patient at home (25     mg taken orally once daily until disease progression) The medication should be taken each day     after a meal at the same time of the day. There are no patient diaries and no need for the     patient to record the time of administration.   "
185209|NCT00261040|"     The purpose of this study is to determine if there is a difference in terms of length of     hospital stay and post-operative outcomes between patients whose total hip replacement     surgery is performed with a minimally invasive versus standard surgical approach.   "
185210|NCT00261053|"     The purpose of this single-center study is to explore the efficacy, safety, tolerability and     pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute     attacks in patients with hereditary angioedema.   "
185211|NCT00261066|"     By investigating the long-term functional status of patients who have undergone various types     of orthopaedic surgery we will have a basis for devising guidelines for future patients and     surgeons.   "
185212|NCT00261079|"     Primary objective:        -  To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus          prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin          disease      Secondary objective:        -  To evaluate patient's satisfaction of Allegra treatment   "
185213|NCT00261092|"     Primary objective:        -  To evaluate overall response rate (based on RECIST criterion)      Secondary objective:        -  To evaluate time to progression, clinical benefit, quality of life and safety   "
185242|NCT00261469|"     The purpose of this study is to evaluate whether prophylactic use of topiramate (preventative     use before a migraine attack) enhances the effectiveness of migraine treatment with triptans.   "
185243|NCT00261482|"     The purpose of the study is to evaluate user experience with the EVRAÂ® Contraceptive     Transdermal Patch; specifically, user satisfaction with the EVRAÂ® Patch, and if applicable,     user preference of the EVRAÂ® Patch compared with the previous method of contraception. The     study also evaluates contraceptive efficacy, safety and user compliance.   "
185987|NCT00271440|"     The purpose of this study is to compare the reductions in skin flora of newborns after a     single cleansing of the body with three concentrations of chlorhexidine (0.25%, 0.5%, 1.0%)     and to examine the safety of skin cleansing in neonates in Nepal.   "
185214|NCT00261105|"     Primary Objectives:        -  The primary objective of the study is to evaluate clinical efficacy i.e. to show that          with respect to clinical cure rate, Ketek® (telithromycin) in the treatment of community          acquired respiratory tract infections: community acquired pneumonia (CAP), acute          bacterial exacerbation of chronic bronchitis (AECB) and acute sinusitis (AS), in          outpatients.      Secondary Objectives:      The secondary objectives are to:        -  Further assess the efficacy of Ketek® (telithromycin) by considering the rate at which          additional antibacterials were prescribed to treat the primary infection; the rate of          hospitalisation due to a complication of the primary infection and assessment of          bacteriological data, chest X-ray and sinus X-ray if available.        -  Evaluate safety of Ketek® (telithromycin) through Adverse Event (AE) and Serious Adverse          Event (SAE) reporting   "
185215|NCT00261118|"     There is broad support for the hypothesis that Ulcerative colitis is an auto-immune disease.     Rituximab is an antibody protein that removes a subgroup of white blood cells (B lymphocytes)     from the circulation. These cells have the capacity to generate the auto-antibodies that     typify auto-immune disease. Although Rituximab has been mainly used for treating B lymphocyte     malignancies (lymphoma) it has also been used with promising results in Rheumatoid arthritis     and has an excellent safety record. This is a small placebo-controlled trial to assess its     efficacy and safety in patients with steroid-resistant active ulcerative colitis.   "
185216|NCT00261131|"     The study proposes to determine if injections of BTX-A to the hamstring muscles result in     measurable physiologic changes not observed with normal saline injections in children with     spastic diplegic cerebral palsy who walk with a flexed-knee gait pattern.   "
185217|NCT00261144|"     The purpose of this study is to determine if collagenase injection will reduce or eliminate     the appearance of cellulite of the thigh.   "
185218|NCT00261157|"     This research is being done to test a two-way video system mounted on top of a robot. After     surgery the act of seeing and evaluating patients in the hospital is called standard     rounding. This research study will allow doctors to see and speak with their patients using     the two-way video system - telerounding, during their stay at the hospital. The purpose of     this study is to assess the safety of telerounding during a patients hospital stay.      Our hypothesis is that post-operative morbidity and the time to identification of     post-operative morbidity will not vary with this new method of rounding.   "
185219|NCT00261170|"     This is a randomized blinded trial of whether hospitalized smokers who are randomly assigned     to receive bupropion, an antidepressant, and cognitive-behavioral counseling, are more likely     to have quit smoking at the end of treatment and at 6 months compared with smokers randomly     assigned to receive placebo and cognitive-behavioral counseling. Because depression is more     prevalent among smokers and because smokers who are prone to depression may become depressed     when they quit, the hypothesis is that the proportion of quitters who receive the active     drug/antidepressant will be greater than the proportion of quitters who receive the placebo     drug at 6 months.   "
185220|NCT00261183|"     We hypothesized that patient will success in benzodiazepine withdrawal if they get melatonin     to solve sleep-problems which commonly occur during benzodiazepine withdrawal. Former heroin     addicts, currently in Methadone maintenance treatment, who are also abusing benzodiazepine,     started self benzodiazepine withdrawal, and got for 6 weeks melatonin (5mg/day, taken every     night) or placebo and after 1 week, additional 6 weeks with placebo or melatonin (double     blind for what got first).Success The benzodiazepine withdrawal success was evaluated by     urine for benzodiazepines, and sleep quality was evaluated using PSQI questionnaire     (baseline,and after weeks 6, 7, 13)   "
185221|NCT00261196|"     The purpose of this study is to test collagenase injection therapy to dissolve adhesions     causing frozen shoulder.   "
185222|NCT00261209|"     The purpose of this study is to dissolve flexor tendon adhesions associated with failed     tendon repair surgery.   "
185223|NCT00261222|"     Design: Single-centre      Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the     efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural     and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN).      Population: Children aged 6-59 months with uncomplicated falciparum malaria (axillary     temperature ≥ 37.5°C + ≥ 2.000 P. falciparum asexual parasites per µl blood) from the health     centre situated in the villages of Bagala, Bourasso and Kemena and from Nouna town hospital     outpatient department.      Sample size: N=120      Treatment: All children will receive a total dose of 25 mg/kg oral AQ over a period of three     days (first and second day: 10mg/kg, third day: 5mg/kg).      Statistical procedures: The primary analysis parameter is the proportion of clinical failures     on day 14. Secondary parameters are the rate of clinical failures on day 28 (with and without     PCR correction), the rate of early clinical failures, the rate of late parasitological     failures (day 14 and day 28), and the rate of adverse events. Data will be analysed in the     overall group of study children and for rural (n=50) and urban (n=50) study children     separately.      Study duration and dates: The study will be implemented in September-December 2005.   "
185224|NCT00261235|"     The purpose of this study is to test the effectiveness of USES, a strengths-based enhancement     to supported employment (SE), as compared to supported employment alone.   "
185225|NCT00261248|"     The purpose of this study is determine whether a vaginal mucosal vaccine given to women with     a history of recurrent urinary tract infections can reduce the number of infections occurring     in a six-month study period, as compared to placebo treatment.   "
185226|NCT00261261|"     Children experience significant anxiety and distress during the preoperative period.     Currently available interventions are ineffective and/or associated with significant     disadvantages. These interventions exclusively target the child and do not attempt to reduce     parental anxiety. Based on an integration of the literature in both the anesthesia and     psychological milieus, we developed ADVANCE, a behaviorally oriented anxiety reduction     program for children undergoing surgery that targets the family as a whole.   "
185227|NCT00261274|"     The purpose of this study is to demonstrate that small amounts of a person's own red cells,     when treated with an enzyme to make A-ECO Red Blood Cells, can be safely re-infused,     repeatedly. Each participant will have some blood drawn, treated with an enzyme, washed and     re-infused five times. Additional samples of blood will be drawn for testing and evaluation.   "
185229|NCT00261300|"     Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and     esophagus. GERD might occur when the lower esophageal sphincter does not close properly and     stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common     medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. One of     the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach     touches the lining of the esophagus, causing a burning sensation in the chest or throat.     Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in     a large proportion of patients.      Additionally, long-term treatment with proton pump inhibitors may be needed for patients with     chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which     is often associated with ulcers in the stomach or duodenum).      The aim of the study is to evaluate the long-term effect of pantoprazole in patients with     chronic gastric acid-related complaints. The study duration consists of a 5-year treatment     period. Pantoprazole will be administered once daily. The study will provide further data on     long-term safety, tolerability, and efficacy of pantoprazole.   "
185230|NCT00261313|"     This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel     (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast     cancer setting.   "
185231|NCT00261326|"     The purpose of this study is to investigate if the simvastatin treatment improve the visual     function after 3 months of the inclusion to this project and if the simvastatin influences     the results on cerebral MRI after 3 and 6 months of the inclusion. In addition the     development of new demyelinating relapses. In the patients with monosymptomatic acut optic     neuritis to investigate whether the simvastatin reduces the risk to develop multiple     sclerosis (MS).   "
185232|NCT00261339|"     Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and     esophagus. GERD occurs when the lower esophageal sphincter does not close properly and     stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common     medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. Proton     pump inhibitors such as pantoprazole, can relieve symptoms of GERD in a large proportion of     patients.      Of particular interest in GERD is the assessment of symptom severity and quality of life, and     the response to treatment. Therefore, a questionnaire was developed to assess GERD symptoms     (`ReQuest TradeMark in Practice`). An important point to consider when using such a     questionnaire is to follow the patients´ medical response to treatment and note whether a     patient needs to change dosing, such as changing from full dose to half dose, or vice versa.      The aim of the study is to determine the value of the questionnaire (`ReQuest TradeMark in     Practice`) according to treating physicians` clinical judgment when using pantoprazole at     full and half dose. The study duration consists of a pre-treatment periods (0-2 weeks) and     two treatment period (8 weeks each). During the first treatment period, pantoprazole will be     administered once daily at full dose (40 mg). During the second treatment period,     pantoprazole will be administered once daily at half dose (20 mg). The study will provide     further data on safety and tolerability of pantoprazole.   "
185233|NCT00261352|"     This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of     tesaglitazar compared with metformin and metformin in combination with fenofibrate in     patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C).     Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment     period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center,     active controlled (metformin with or without fenofibrate) treatment period and a 3-week     follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin     (rosuvastatin)   "
185234|NCT00261365|"     The purpose of this study is to identify candidate markers predictive of response and/or     serious toxicity to BMS-734016 (MDX-010).   "
185236|NCT00261391|"     3 patients were enrolled in each of 3 study cohorts. There three cohorts were given     differing, incrementally larger doses of this phase I drug. The same safety measures are     being obtained on all patients. Efficacy measures were individualized as enrolllees do not     have the same underlying vascular anomaly. The study is structured to include a 24 month     drug-phase and a 24 month follow-up phase. The study is now closed to enrollment.   "
185237|NCT00261404|"     Phase II, open label study in which patients with metastatic melanoma (stage III or IV) who     have cancer which is not considered curable by surgery will receive intratumoral injections     of TNFerade™ plus radiation as a 4-week treatment, followed by a 3 year follow-up period.   "
185238|NCT00261417|"     This is a 12-week study to determine the effect on glucose and lipids, safety, and     tolerability of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) compared with placebo     in patients with type 2 diabetes. Improvement in dyslipidemia will be evaluated. The study     comprises a 2-week screening period, 4-week placebo run-in, a 12-week randomized, double     blind, parallel group, multi-center, placebo-controlled treatment period, and a 3-week     follow-up.   "
185239|NCT00261430|"     The purpose of this study is to examine treatment practices of adult schizophrenia patients     by their own doctors, and to assess patient outcomes when treated with long-acting     risperidone injection over a two-year period of observation.   "
185240|NCT00261443|"     The purpose of this clinical research study is to learn if outpatients with bipolar mania who     are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms     on a combination treatment of aripiprazole plus lithium or valproate.   "
185241|NCT00261456|"     The IMPACT study is an international targeted prostate screening study of men at increased     prostate cancer risk due to the presence of known pathogenic mutations in BRCA1 and BRCA2     genes.      There are only approximately 150 men with a known BRCA1 or BRCA2 mutation in the UK. Research     has shown that these men are at an increased risk of developing prostate cancer but more     information is needed about the pathogenesis of prostate cancer in this defined group and the     role of screening in these men. The study will offer annual PSA screening to these men to     determine the incidence of prostate cancer in this group. The study will also look at new     markers of early prostate cancer in this cohort.      The power calculations for this study are 850 carriers and 850 controls (age-matched men     without BRCA1/2 mutations). It is therefore essential to gain international collaboration to     meet the target of recruiting 850 men with these known mutations and a control group of 850     men who have tested negative for a known familial mutation.   "
185244|NCT00261495|"     The purpose of this study is to compare the effectiveness and safety of sustained- release     hydromorphone, formulated to release slowly over time, taken once daily, and controlled-     release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will     also determine the dose of sustained-release hydromorphone that provides a level of pain     control that is equal to the pain control provided by control-released oxycodone     (equi-analgesic dosage).   "
185245|NCT00261508|"     The purpose of the study is to evaluate the effectiveness of an oral solution of risperidone     (an antipsychotic medication) versus placebo in the treatment of behavioral symptoms in     children with Pervasive Developmental Disorders (PDD).   "
185246|NCT00261521|"     The purpose of this study in early hemodialysis patients (on dialysis 3 to 18 months) is to     assess the effect of correction versus partial correction of anemia using epoetin alfa on     heart pumping function.   "
185247|NCT00261534|"     The purpose of this study is to examine the degree of fatigue in patients receiving     chemotherapy. Special interest goes out to the course of fatigue throughout five treatments     and the actions taken by patients to reduce this fatigue.The correlation between fatigue and     haemoglobin will also be subject of study.   "
185248|NCT00261547|"     The purpose of this study is to determine if administration of rituximab blocks the     development of donor specific antibodies (DSA) in transplant recipients who have developed     renal dysfunction and DSA after renal transplant. It is hoped that by blocking DSA production     renal function will stabilize or improve.   "
185249|NCT00261560|"     The purpose of this study is to compare the safety and effectiveness of 1300 mg acetaminophen     extended release given three times daily for nine days to that of 400 mg ibuprofen given     three times daily for nine days for the signs and symptoms of (Grade I and Grade II) lateral     ankle sprains.   "
185250|NCT00261573|"     The purpose of this study is to evaluate the safety and efficacy of galantamine (a drug for     treating dementia) compared to placebo in the treatment of patients with dementia related to     cerebrovascular disease (vascular dementia) or dementia related to Alzheimer's disease with     cerebrovascular disease (mixed dementia).   "
185251|NCT00261586|"     The purpose of this study is to compare several analgesics given in approved daily doses in     combination with a daily cardioprotective dose of aspirin (81 mg), to study their bleeding     properties and their effects on the stomach in healthy volunteers.   "
185252|NCT00261599|"     Very often patients receive medication before a diagnostic procedure, like a colonoscopy, to     help them relax and stay calm during the procedure. This is called procedural or     minimal-to-moderate sedation. One product used for sedation is called propofol. AQUAVAN     (fospropofol disodium) is made as a water soluble form of propofol allowing for rapid     sedation during the entire procedure. This study is designed to test AQUAVAN for sedation     during colonoscopy procedures.   "
185253|NCT00261612|"     Mantle cell lymphoma (MCL) remains difficult to treat by standard treatment approaches. Novel     drugs have shown promising results in early clinical evaluations. In the current trial, we     investigate a combination of bortezomib (a proteasome inhibitor), rituximab (a monoclonal     antibody), and dexamethasone in patients with MCL, who have already been pretreated by     standard chemotherapy and show again signs of disease progression. The study objectives     include remission rates, safety of this drug combination, and survival time.   "
185254|NCT00261625|"     Alendronate is a safe and effective drug for treating osteoporosis in post-menopausal women.     However, its safety and efficacy in increasing bone mineral density in chronic peritoneal     dialysis (PD) patients have not been investigated. Etidronate, another bisphosphonate, can     suppress the extent of coronary artery calcification in chronic hemodialysis patients. The     hypothesis of this study is that alendronate can increase bone mineral density and suppress     aortic and coronary artery calcification in chronic peritoneal dialysis patients.   "
185255|NCT00261638|"     “Health” includes physical and mental aspects. The evaluation of “Mental Health” contains     four domains: psychophysical health, perceived security of the living world, meaning and     worth of life, satisfaction of family-social interaction.      We have established a Taiwan Mental Health Index scale based on literature review and     experts’ opinions in 2002. The reliability and validity were assessed to be satisfactory.     This TMHI scale has been applied in nation-wide mental health surveys of 2002, 2003, and     2004.      In order to evaluate the effect of mental health promotion activities, this research project     will adopt this TMHI scale as the assessment tool. 300 people will be recruited for study     after signing the informed consent. The general population sample of 1076 subjects recruited     in 2004, will be as the comparison sample. The difference in 4 dimensions of MHI will be     analyzed between these two study groups. The 300 study subjects will be subcategorized into     two groups of low and high attendance groups. The difference in MHI between groups will also     be statistically examined using independent t-test. The statistical signification is set at     α=0.05.      This study result will be as the reference for setting up effective mental health promotion     program for general public.   "
185256|NCT00261664|"     Telehomecare is a technology that individuals use in their homes to communicate with health     providers electronically. This technology can help them function at a higher level and avoid     undesirable hospitalizations by making changes in their everyday behaviors, but research is     needed to understand how telehomecare supports health behavior change and leads to improved     health status.      The hypothesis being tested is that the use of an electronic method of monitoring and     transmitting health information facilitates patient empowerment, with subsequent effects on     the patient's ability to manage her/his treatment regimen more effectively. The study will     explore the relationship between telehomecare and acquisition of knowledge, and will show     whether changes in knowledge levels translate to changes in behaviors and improved health     outcomes. The effects of two different telehomecare systems (nurse-directed vs.     patient-directed) on knowledge, self-management, and health status will be compared. A     further goal is to illuminate the attitudes of physicians regarding the use of telehomecare     in the treatment of their elderly, community dwelling patients.      Results will inform managers and policymakers who are responsible for integrating eHealth     mechanisms into chronic disease protocols, funding health care programs, and creating     policies that support the use of information technology by all Americans.   "
186779|NCT00282360|"     Patients with coronary artery disease have an abnormal cardiac metabolism. The hypothesis of     this study is that shifting cardiac metabolism from free fatty acids to glucose will improve     myocardial ischemia   "
185257|NCT00261677|"     The purpose of this study is to evaluate the safety and effectiveness of once- weekly dosing     of PROCRITÂ® (a glycoprotein that stimulates red blood cell production) versus placebo in the     treatment of anemia in children with cancer undergoing chemotherapy, and to assess its effect     on the quality of life.   "
185258|NCT00261690|"     Using Virtual Reality as a form of Distraction during Burn Care.   "
185259|NCT00261703|"     Primary Objective:        -  Phase II: To determine the best treatment scheme (TPF vs. PF).        -  Phase III: To compare the time to progression and the treatment failure at the 3 arms.      Secondary objectives:        -  To evaluate the safety at the 3 arms.        -  To compare the progression , overall survival and locoregional control at the 3 arms.   "
185260|NCT00261716|"     Many persons with schizophrenia have difficulty getting and keeping a job. This study is     designed to compare the benefits of four sessions of motivational interviewing or illness     education in increasing employment rates accruing from participation in supported employment.   "
185261|NCT00261729|"     Evaluate the efficacy and tolerability of the drug prazosin compared to placebo for combat     stress-related nightmares, sleep disturbance and overall function in recently combat-exposed     returnees from OIF and OEF. To evaluate the effects of the SSRI paroxetine on behavioral     symptoms and overall function in this population.   "
185262|NCT00261742|"     The goal of the study is to investigate, which of two antibiotic treatments - oral penicillin     for 10 days or oral cefuroxim for 7 days - is more successful for patients (1-16 years of     age) with perianal dermatitis caused by group A beta-hemolytic streptococci.   "
185263|NCT00261755|"     The purpose of this study is to investigate the effect of acupuncture for pain relief and     relaxation during childbirth.   "
185264|NCT00261768|"     The purpose of this study is to see if noise reduction programs in digital hearing aids help     patients hear better than hearing aids without these programs. We also want to know if we can     predict how successful patients will be with hearing aids.   "
185265|NCT00261781|"     The major aim of this study is to determine the efficacy of a home-based treadmill walking     program in improving walking capacity and quality of life in people with early mid-stage     Parkinson's disease(PD).   "
185266|NCT00261794|"     The purpose of this study is to evaluate the efficacy of an innovative, computer driven     cognitive rehabilitation program for unemployed veterans with schizophrenia.   "
185267|NCT00261807|"     Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive     cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI)     with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior     to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did     not include any patients with clostridial infection, there is in vitro data to support the     activity of daptomycin against a variety of clostridial species(11) ( Clostridium     perfringens) Therefore, for this trial we will include patients with clostridial infections     with this species. Additionally, the patients in the SSTI study were not as ill as the     proposed study population. Therefore for treatment of such severe infections, we would like     to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of     daptomycin in this subgroup are as follows:        1. Patients who are severely ill have an increased volume of distribution; and therefore          have a lower serum concentration of daptomycin. These patients might require a higher          dose of daptomycin to achieve the desired serum concentration.        2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and          faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the          drug to achieve adequate free (unbound) serum concentration of the drug.        3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The          clinical trials for endocarditis are using 6mg/kg/dose of daptomycin.      Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should     use the higher dose of daptomycin.      Objective:      To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin     therapy in the treatment of patients with severe necrotizing skin and soft tissue infections.      Type of Study:      Open label, single center study.   "
185268|NCT00261820|"     Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12     months after transplantation in patients receiving either a regimen of sirolimus plus     mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining     tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients     undergoing renal allograft transplantation. In addition, the two treatment groups will be     compared with respect to the incidence of acute rejection at 3, 6 and 12 months following     transplantation, and the patient and graft survival at 6 and 12 months after transplantation.     The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will     be evaluated beginning in the immediate post-operative period.   "
185269|NCT00261833|"     This is a randomized, placebo-controlled, double-blind, multicenter phase III/IV study to     compare the efficacy and safety of Zemaira® with placebo in subjects with emphysema due to     alpha1-proteinase inhibitor deficiency. The effect of Zemaira® on the progression of     emphysema will be assessed by the decline of lung density, measured by computed tomography     (CT).   "
185270|NCT00261846|"     This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606     (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation     study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum     tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of     Part 1 and after a dose has been established for the compound in chronic phase subjects. Part     2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all     phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the     hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic     Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in     advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.   "
185271|NCT00261859|"     The purpose of this study is to evaluate the effectiveness of an enhanced emergency     practitioner (EP) performed brief intervention (BI), namely, the Enhanced Brief Negotiation     Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary     care provider, followed by a telephone booster intervention performed by trained nurses     1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and     standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled     clinical trial 900 hazardous and harmful (HH) drinkers will be randomly assigned to one of     the 4 conditions. We, the researchers at Yale University, will conduct cost benefit analysis     of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via     interactive voice response (IVR).   "
185307|NCT00262340|"     The purpose of this study is to determine whether using non-invasive measurements of airway     inflammation can improve clinical decision making in children with severe asthma compared to     conventional management (British Thoracic Society Guidelines)   "
185272|NCT00261872|"     This study of persons with both alcoholism and ADHD will determine whether adding the drug     methylphenidate to a standard treatment program will decrease alcohol use. In approximately     half of patients with ADHD, symptoms persist into adulthood, and the untreated condition is     associated with a significantly increased incidence of substance use disorder. Also, more     than one-third of adults with substance use disorder have symptoms of ADHD. This study will     evaluate the effectiveness of adding methylphenidate to a standard alcohol treatment program     in improving patients' treatment compliance and decreasing adverse consequences of drinking,     as well as monitoring their attention deficit/hyperactivity symptoms,      People 21 to 65 years of age with alcoholism and attention deficit hyperactivity disorder     (ADHD) may be eligible for this study.      Participants are randomly assigned to receive either slow-release methylphenidate (an     approved medication for ADHD) or placebo. All subjects participate in NIAAA's alcohol     treatment program, which includes a standardized 12-week behavioral therapy course and     treatment with naltrexone, a medication to prevent relapse. Patients are assessed once a week     with the standard NIAAA treatment evaluation battery, including:        -  Timeline Followback: A validated self-report method to assess a person's drinking over a          defined interval in time        -  Addiction Severity Index: A validated interview that measures problem severity in seven          areas related to drug and alcohol abuse        -  Biomarkers for alcohol abuse        -  Conners Adult ADHD Rating Scale (a rating scale for ADHD symptoms and severity)   "
185273|NCT00261898|"     OBJECTIVE: Obesity and chronic sleep deprivation have both become increasingly pervasive     medical problems in recent years. The prevalence of adult obesity has doubled over the past     30 years and continues to increase. In addition, industrial societies attach an economic     value to maximizing the waking period to the longest tolerable limit by sleeping as little as     possible. Average sleep time has decreased over the last century by 2 hours. Chronically     sleeping less has been associated with increased weight, endocrine and metabolic health risks     including glucose intolerance, cardiovascular disease, and mortality. The possibility that     the current epidemic of obesity and metabolic health risks may be partially related to     insufficient sleep is now being recognized. The objective of this proof-of-concept controlled     trial is to investigate the impact of increasing sleep time in chronically sleep-deprived,     obese subjects.      STUDY POPULATION: 18-50 year old, obese (BMI 30-50) men and premenopausal women, chronically     sleep deprived, recruited from the Baltimore-Washington metropolitan area. Chronic sleep     deprivation will be verified by the use of sleep logs and the use of actigraphy before entry     into the study. Secondary causes of sleep deprivation such as insomnia, psychological     (depression), and medical conditions associated with poor sleep quality (including     obstructive sleep apnea) will be exclusionary criteria.      DESIGN: This is a randomized, 12-month duration, comparison-controlled clinical trial of an     extension of sleep up to approximately 7 hours and 30 minutes (Intervention Group) or     continuation of habitual short sleep schedule (Comparison Group). The proposed treatment is     an educational and behavioral intervention aimed at increasing sleep in a non-pharmacological     fashion. The main analysis of the study will be to determine if additional sleep will result     in a significant difference in body weight at the end of 12 months between the Intervention     Group and the Comparison Group. In addition, we would like to establish whether 12 months of     additional sleep will result in: a) a decreased prevalence of metabolic syndrome; and b)     changes in the endocrine profile (i.e. inducing changes in leptin [increase] and ghrelin     [decrease] opposite to the changes associated with chronic sleep deprivation). At the end of     the 12-month intervention study (Phase 1, Efficacy Randomized Phase Study), all participants     will be given information about the potential benefit of more sleep and encouraged to     increase sleep time. Health teaching about proper nutrition and adequate exercise will also     be provided at that time to the Intervention and Comparison Groups. All participants will be     evaluated 6 months later to assess the effects of this intervention in a real-life situation,     and offered participation in a three-year extension with semi-annual visits (Phase 2,     Effectiveness 3 Year Follow-Up Phase Study), for which matched external comparison subjects     will also be recruited ad hoc.      OUTCOME PARAMETERS: body weight, average number of hours of sleep/night, fasting glucose and     insulin, oral glucose tolerance test, leptin, ghrelin, adiponectin, other relevant endocrine     and anthropometric measures, body composition, various metabolic parameters, food intake,     energy expenditure, and quality of life measures.   "
185274|NCT00261911|"     The purpose of this study is to assess the effectiveness of sibutramine on weight loss,     reduction in body size and improvement in metabolic risk factors and safety in obese     adolescents.   "
185275|NCT00261924|"     Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7     days are safe and effective compared to platelets collected by the same method, stored for     the same amount of time and not treated for pathogen inactivation.   "
185276|NCT00261937|"     We hypothesize that inhaled Furosemide will be an effective treatment in infants with acute     bronchiolitis.   "
185277|NCT00261950|"     The purpose of this study is to evaluate the effects of cinacalcet on markers of bone     turnover in patients with kidney disease who are receiving dialysis.   "
185278|NCT00261963|"     The purpose of this study is to examine the effect of UV-irradiation on human cutaneous     cicatrices by clinical examinations and histological, immunohistochemical and biochemical     analyses.   "
185279|NCT00261976|"     This is a study evaluating the long-term safety of infliximab (Remicade)   "
185280|NCT00261989|"     The aim of this study is to describe the presenting pulse oximetry reading in patients who     have a known lesion which will cause them to have a low presenting oximetry reading. The     study hypothesis is that there is a low presenting pulse oximetry in patients with congenital     heart disease and that there will be no significant variation in the hourly variation in     oximetry readings in these patients.   "
185281|NCT00262002|"     The purpose of this study is to evaluate the safety, immunogenicity and induction of immune     memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate     Vaccine administered to healthy infants.   "
185282|NCT00262015|"     The purpose of this study is to determine when a memory immune response after re-vaccination     with Meningococcal C conjugate vaccine (Menjugate) or challenge with Meningococcal A/C     polysaccharide vaccine can be observed, after initial vaccination with Meningococcal C     conjugate vaccine during the UK immunization campaign   "
185283|NCT00262028|"     The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly     Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10     years   "
185286|NCT00262067|"     This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate     the efficacy and safety of bevacizumab in combination with chemotherapy compared with     chemotherapy alone in subjects with previously untreated metastatic breast cancer.   "
185287|NCT00262080|"     The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an     investigational product) is safe and relieves symptoms of HAE in patients suffering from     moderate to severe acute attacks of HAE.   "
185288|NCT00262093|"     The reason for having a higher incidence of preeclampsia in primiparas may involve     angiogenesis imbalance in these patients.   "
185289|NCT00262106|"     The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5     gels compared to placebo in preventing vaginally acquired HIV infection.   "
185290|NCT00262119|"     The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and     atrial preventive and antitachycardia pacing therapies on the reduction of a composite     clinical outcome composed of any death, permanent atrial fibrillation, and cardiovascular     hospitalizations.   "
185291|NCT00262132|"     Corticosteroids are presently the drug of choice for the treatment of pulmonary sarcoidosis.     However, corticosteroids are associated with many significant side effects. For this reason,     it would be beneficial to find an alternative agent to corticosteroids for the treatment of     pulmonary sarcoidosis. This study is an open label trial of mycophenolate for new onset     pulmonary sarcoidosis. Patients are candidates for this study if they have biopsy proven     pulmonary sarcoidosis and a vital capacity or FEV1 less than 80% of predicted. Patients must     undergo bronchoscopy where not only is the diagnosis of pulmonary sarcoidosis required, but     in addition, cells are obtained from bronchoalveolar lavage. If the patients are diagnosed     with pulmonary sarcoidosis, they are placed on an initial dose of 500mg BID of mycophenolate     for 1 week. If their blood counts are not affected on this dose and they have no significant     symptoms that are thought to be drug related, then their dose is escalated to 1g BID for the     remaining 9 weeks of the study (the total study drug therapy time is 10 weeks). The patients     are followed with multiple study visits. At these visits blood tests are drawn to make sure     that there are no significant side effects from mycophenolate. In addition, the patients have     a history and physical performed to evaluate the clinical state of their sarcoidosis and to     detect mycophenolate side effects. On completion of 10 weeks of mycophenolate therapy, the     patients undergo a second bronchoscopy with bronchoalveolar lavage to obtain cells for     analysis. The patients are evaluated with spirometry, measurements of shortness of breath     (dyspnea), and a quality of life scale (SF36) at serial visits during their study. The     primary endpoint of the study is improved, unchanged or worse FVC. It is hoped that this     pilot study will suggest that mycophenolate is a reasonable treatment option for new onset     pulmonary sarcoidosis.   "
185308|NCT00262353|"     Comparison of the efficacy of dialysis by conventional dialysis versus Prometheus artificial     hepatic system   "
185309|NCT00262366|"     Comparison of automatic CPAP with fixed CPAP in patients with OSAS   "
185310|NCT00262379|"     The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with     peginterferon plus ribavirin.   "
186822|NCT00288457|"     The Study of whether or not Ureteral Stent Length affects patient comfort after electro-shock     wave treatment for kidney stones.   "
185292|NCT00262145|"     Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to     reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and     carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by     the intestinal mucosa). There has been some study of the ability of these products to reduce     the blood glucose increase observed after a carbohydrate meal and to reduce blood cholesterol     levels in chronic studies. The purpose of the present study is to objectively determine if     one cup of “tea” made from a combination of three types of tea leaves (mulberry, black and     green tea) can cause malabsorption of carbohydrate and fat taken in conjunction with the tea.      Research Design - The study will consist of a double blind, placebo controlled crossover     study in 20 healthy subjects. On one of two days (one week apart) the subjects will ingest a     standard meal consisting of 30 g of sucrose (in the tea) and 30 g of starch in the form of     white rice plus 10 g of fat as butter. To measure triglyceride absorption, each meal will     also contain 250 mg of 13-C labeled triolein. Triolein is a commonly ingested fat consisting     of glycerol bound to three oleic acids. 13-C is a stable (non-radioactive) isotope of carbon.     On one of the test days the subjects (randomly) will concurrently consume the active     preparation, a tea containing extracts of the three types of tea leave described above plus     the meal, and on the other test day they will consume the meal with a liquid placebo     preparation (warm water, sugar and food coloring). Subjects will provide a breath sample     before and at hourly intervals for 8 hours after ingestion of the meal. Carbohydrate     malabsorption will be determined by the hydrogen concentration in the breath samples and fat     malabsorption by the concentration of 13-CO2 in the breath samples.      Clinical Significance - An increase in breath hydrogen indicates carbohydrate malabsoption     and a low 13-CO2 indicates lipid malabsorption. Objective evidence that the tea leaf extract     actually induces carbohydrate and/or fat malabsorption could provide the basis for further     studies.   "
185293|NCT00262158|"     This project is the survey on smoking behavior in Taiwan. The survey information will be used     to analyze the influence of the earmarked tax of cigarettes on (1)the consumption of     cigarette,(2)the substitution between the consumption of domestic and imported cigarettes,     and(3)the consumption of other addictive goods.   "
185294|NCT00262171|"     The purpose of this study is to establish the HNPCC related information in Taiwan, and to     characterize relevant susceptibility genes related to colorectal cancer to provide better     disease control for the high-risk people. To accomplish this objective, we will collect     detailed information of the HNPCC patients and their families from the collaborative     hospitals and relate the information to the risk of CRC in order to provide sound disease     control system in Taiwan.   "
185295|NCT00262184|"     Consumption of soy-based foods is associated with a number of health benefits, including     lower risk of cardiovascular disease, breast and prostate cancer, attenuated menopausal     symptoms and prevention of bone loss with age.      In order to investigate the effect of isoflavone on bone mineral density (BMD) and in Taiwan     women with postmenopausal osteopenia, a Taiwan Isoflavone Multicentric Enrollment Study     (TIMS) is designed.   "
185296|NCT00262197|"     This project evaluates a HPMG effort to reduce error rates through customized direct feedback     of diabetes quality of care data to diabetes patients and their physicians. HPMG has     routinely provided patients with personalized feedback of glucose and cholesterol test     results since about 1997. This project will implement and evaluate the impact of this     intervention on diabetes medical error rates and resource use.   "
185297|NCT00262210|"     * AIMS OF THE STUDY        1. To test if steroid-free chemotherapeutic regimens decrease the risk of HBV reactivation          and hepatitis development in HBsAg (+) carriers.        2. To compare the efficacy of steroid-free chemotherapeutic regimens with that of          steroid-containing regimens in terms of lymphoma control.        3. To study the change of activity of HBV and other hepatotropic viruses during the course          of chemotherapy.   "
185298|NCT00262223|"     This treatment intervention trial is designed for men and women with either alcohol misuse     (e.g. hazardous or binge drinking) or alcohol use disorders (alcohol abuse or dependence) and     comorbid PTSD. Participants will be randomly assigned to one of two treatments (a cognitive     behavioral treatment intervention called Seeking Safety + Medication (Zoloft) or Seeking     Safety + placebo) and will be evaluated at baseline, at completion of the treatment (12     sessions over 12 weeks), and again at 6 months and 12 months post-treatment.   "
185299|NCT00262236|"     This is a study for people diagnosed with hypertension to compare the safety and     effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in     the study for 12 weeks.   "
185300|NCT00262249|"     This trial is conducted in the United States of America (USA). The purpose of the trial is to     compare the effect of Norditropin® using different dosing regimens in children suspected of     growth hormone deficiency.   "
185301|NCT00262262|"     The aim of this study is determine whether or not the antiepileptic drug Levetiracetam is an     effective treatment of the postmastectomy pain syndrome.   "
185302|NCT00262275|"     To investigate the effect of different dosages of aspirin on platelet aggregation and to     determine the possible mechanisms of aspirin resistance, we intend to compare the effects of     low, medium dose aspirin with clopidogrel (an alternative antiplatelet agent) in patients     after coronary artery bypass surgery.   "
185303|NCT00262288|"     The purpose of this multi-center study is to explore the efficacy, safety, tolerability and     pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute     attacks in patients with hereditary angioedema.   "
185304|NCT00262301|"     Hereditary angioedema (HAE) is a genetic disorder characterized by sudden recurrent attacks     of local swelling (angioedema). These attacks are often painful and disabling, and, in some     cases, life-threatening. HAE is caused by mutations in the C1INH gene that leads to a     decrease in the blood level of functional C1INH. This multi-center study was designed to     assess the safety and tolerability, efficacy and pharmacodynamics/ pharmacokinetics of     recombinant human C1 inhibitor (rhC1INH) in the treatment of acute hereditary angioedema     attacks.   "
185305|NCT00262314|"     The overall objective of this study is to collect data relevant to the tolerability of     Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring     recommendations specified in the package insert.   "
185306|NCT00262327|"     The growth and metastasis of solid tumors are dependent on angiogenesis. Endostatin, the     C-terminal proteolytic fragment of collagen XVIII, is an effective endogenous angiogenesis     inhibitor in cancer therapy in mice. Applied for clinical studies in solid tumor, however,     recombinant human endostatin protein, difficulties in a large-scale production of the     recombinant endostatin protein, and the cumbersome daily administration. Up to now, its     clinical application has been hampered by those matters. We herein constructed a adenoviral     vector ecoding human endostatin. This study will test the safety and efficacy of recombinant     human endostatin adenovirus (Ad-rhE) in the treatment of patients with advanced solid tumors.   "
186823|NCT00288470|"     A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for     correction of facial wrinkles.   "
185312|NCT00262405|"     Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic     pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and     physiologic assessment at baseline. Subjects will be monitored off treatment for three months     for changes in symptoms and physiology. Subjects will then be randomized to six months of     treatment with zileuton or azathioprine/prednisone. The primary endpoint of this trial is     change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment.     Secondary endpoints are progression free survival, change in dyspnea, change in quality of     life, and change in physiology.   "
185313|NCT00262418|"     Comparison of the efficacy and safety of a single administration of ivermectin to a single     administration of permethrin for the treatment of scabies   "
185314|NCT00262431|"     The study aims to assess early (one to three days after intubation) tracheostomy     effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.   "
185315|NCT00262444|"     Evaluation of the difference in pressure ulcer incidence or the time to develop pressure     ulcers depending on the turning frequencies.   "
185316|NCT00262457|"     The purpose of this study was to determine the feasibility of an implanted electrical     stimulation system incorporating BION microstimulators for long term use to prevent tissue     breakdown in high risk patients.   "
185317|NCT00262470|"     This trial is designed to study the effects of various mechanistically unique medications in     controlling excessive increases in heart rate with standing and in improving the symptoms of     orthostatic intolerance in patients with this disorder.   "
185318|NCT00262483|"     To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with     hepatitis C.   "
185319|NCT00262496|"     The purpose of the study is to determine whether Botulinum-A toxin injected in the bladder     muscle will help prevent the frequency and degree of urinary incontinence in Spinal Cord     Injured and Multiple Sclerosis patients. The proposed mechanism would be that the Toxin would     allow the bladder to hold more urine at a lower pressure as determined by Urodynamics. The     research will answer the question whether the dosages 300 units vs 400 units are either     equally vs not equally effective in helping urinary incontinece and bladder storage.   "
185320|NCT00262509|"     The purpose of the research project is to develop and evaluate an emergency egress system for     persons with visual impairment, which would use existing lighted exit signage to provide     egress information at a distance of up to 100 feet.   "
185321|NCT00262522|"     The purpose of this study was to compare the safety and tolerability of the to-be-marketed     lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC)     formulation and to compare the safety, tolerability, and antiviral activity of once daily     (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select     nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously     received antiretroviral treatment.   "
185322|NCT00262548|"     The purpose of this study is to determine whether treatment with rosuvastatin for 6 months in     obese type 2 diabetic women will improve their lipid profiles and thus prevent the     progression to cardiovascular disease.   "
185323|NCT00262561|"     263 patients with peripheral atherosclerosis were examined to evaluate the activity of the     platelets during the standard treatment, including aspirin. A subgroup of 43 received 600 mg     of clopidogrel 2 h before platelet reactivity analysis.      The main hypothesis is that high platelet activity at the beginning of the study is     associated with a higher risk of atherothrombosis. Follow up time is 5 years.   "
185324|NCT00262574|"     Patients receiving BNP or nitroglycerin (IV) during the angioplasty procedure. 24 h after the     procedure, vascular reactivity will be re-examined using the brachial artery flow-mediated     dilatation study. Blood assays for ET-1, pro-BNP, and various inflammatory markers will be     checked before and 24 h after the procedure. It is our hypothesis that endothelial function     will be better in the BNP treated patients compared to the NTG treated patients   "
185325|NCT00262587|"     International studies have shown that elite athletes have a high prevalence of respiratory     symptoms and asthma as compared to normal subjects. It is unclear whether the increased     prevalence of asthma in elite athletes reflects traditional asthma or whether it is a     special form of sports asthma. The treatment of elite athletes with asthma seems to vary     widely, and only a few studies have focused on the treatment of elite athletes with asthma.     Further knowledge of the pathogenesis of sports asthma would lead to a greater understanding     and better treatment of the condition. This study will investigate the type of airway     inflammation in elite athletes and examine the effect of treatment with inhaled steroids in     combination with long-acting beta-agonists versus placebo in the same group.   "
185326|NCT00262600|"     The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran     etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and     systemic embolism.   "
185327|NCT00262613|"     In animal models, sodium pyruvate has been shown to be an effective anti-inflammatory agent,     and in human studies sodium pyruvate has been shown to be a bronchodilating agent. Subjects     with COPD are known to have inflammation in the lung, and often have bronchoconstriction. As     such, these subjects typically are on multiple therapies, including steroid therapy. This     trial will study the effect of inhaled sodium pyruvate on inflammation and lung function in     COPD subjects over a six week period.   "
185338|NCT00269659|"     A left bundle branch block (LBBB) is related to abnormal cardiac conduction and mechanical     asynchrony and is associated with hypertension and coronary artery disease. Improved     evaluation of left ventricular (LV) mechanical asynchrony is needed, because of the     increasing number of patients with a LBBB and heart failure. A variety of patterns of     mechanical activation can be observed in LBBB patients.      Novel imaging modalities such as tissue Doppler imaging, real-time 3D echocardiography and     cardiovascular magnetic resonance imaging provide information about regional and global LV     function in healthy subjects, patients without a LBBB with heart failure, patients with a     LBBB without heart failure, and patients with a LBBB with heart failure.      The investigators want to evaluate the different patient groups with the novel imaging     modalities and they want to compare the novel imaging modalities with each other.      The investigators hypothesized that, between the groups, differences concerning regional and     global LV function are measurable.      Each novel imaging technique has its own advantages and limitations but are comparable in     measuring regional and global LV function.   "
185328|NCT00262626|"     Glaucoma is a disease which affects between one and two percent of all individuals aged over     40 years. According to recent Canadian National Institute for the Blind figures, it is the     second largest specific cause of blindness in this country. The most common form of glaucoma,     open-angle glaucoma, is incipient and typically results in a progressive loss of vision     without symptoms due to damage to a structure inside the eye called the optic nerve head.     Although the most important known risk factor for the development of open-angle glaucoma is     high intraocular pressure (the pressure within the eyeball), a number of researchers have     shown that a sizeable proportion of patients continue to lose vision in spite of successful     treatment to lower their intraocular pressure. This finding suggests that there may be     additional risk factors involved. Ocular vasospasm (the inability of certain blood vessels to     dilate and increase blood flow according to the needs the eye) and vascular disease are among     other factors implicated but their roles have not yet been fully investigated. The Canadian     Glaucoma Study Group proposes to investigate the role of risk factors, including vasospasm     and vascular disease, involved in the progression of open-angle glaucoma. We will recruit 410     patients with open-angle glaucoma across 4 centres (Halifax, Vancouver, Montreal and Toronto)     who will be treated by experienced investigative ophthalmologists according to a uniform     standard protocol to ensure that all patients are managed in the same manner. The patients     will be followed meticulously with the most modern and accurate tests available every four     months for a period of 5 years to determine whether progression has taken place. Visual     function will be measured using two techniques called conventional perimetry and     blue-on-yellow perimetry, and optic nerve heads will be examined with a special scanner     capable of three-dimensional imaging. By defining both the ocular and systemic profiles of     patients who progress and do not progress, we may be able to identify which patients will     benefit from the standard treatment of intraocular pressure reduction, such as that     prescribed in the study. More importantly, we will identify the characteristics of patients     who do not benefit from standard treatment, so that alternative ones may be developed. Such     studies are clearly necessary, but have not yet been conducted. We believe that the proposed     study will increase our knowledge of open-angle glaucoma and reduce its impact on blindness     and visual disability.   "
185329|NCT00262639|"     This is a placebo controlled trial (some people receive active and some people receive     inactive medication) to evaluate the effectiveness of a new protocol to treat alcohol     dependence. Two main medications (plus ancillary non-placebo controlled medications) and     their placebos (inactive drugs) will be utilized to treat both alcohol withdrawal, promote     abstinence, and reduce drinking over approximately a six-week treatment period. All     participants will meet criteria for Alcohol Dependence and be drinking heavily up until 72     hours prior to receiving the first study drug. They will be injected one drug (flumazenil or     placebo) over a two day period and receive the second one (gabapentin or placebo) by mouth     for 39 days. The main hypothesis is that this protocol will reduce early alcohol withdrawal     symptoms and will reduce relapse to drinking and promote abstinence compared to the placebo     (inactive) drug group. Secondary outcomes that will be evaluated include reduction in     craving, improvement in sleep, brain activity and mood.   "
185330|NCT00262652|"     Sodium pyruvate in sodium chloride solution will be delivered by nebulization to the lungs.     It is believed that this administration will produce bronchodilation in asthmatics as     determined by improvement in FEV1. FEV1 is a measure of lung function, and will be determined     after administration of sodium pyruvate. The study is a blinded, so subjects may receive     either the sodium pyruvate or a sodium chloride placebo. The primary endpoint will be the     improvement of FEV1 after 15 minutes in subjects receiving sodium pyruvate compared to the     FEV1 of subjects receiving the sodium chloride placebo.   "
185331|NCT00262665|"     The purpose of this study is to test a candidate drug, Org 24448,in a phase II clinical trial     in adult patients with moderately treatment-resistant unipolar major depressive disorder.   "
185332|NCT00262678|"     The purpose of this study is to determine the effectiveness and safety of sublingual fentanyl     tablets in relieving breakthrough pain in cancer patients.   "
185333|NCT00269594|"     The goal of the proposed study is to evaluate the efficacy and safety of Lamictal in neurotic     excoriation. Twenty subjects with neurotic excoriation will receive 12 weeks of open-label     treatment with Lamictal. The hypothesis to be tested is that Lamictal will be effective and     well tolerated in patients with neurotic excoriation. The proposed study will provide needed     data on the treatment of a disabling disorder that currently lacks a clearly effective     treatment.   "
185334|NCT00269607|"     The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants     as relapse prevention for patients that are completing treatment for opiate addiction in     inpatient (or similarly controlled) settings. Participants in the naltrexone experimental     group are prematched in a pairwise fashion with other patients who do not want a naltrexone     implant during the first six months after ending inpatient treatment, but who reiceive     treatment as usual (TAU) from the Norwegian healthcare system.      The hypotheses are that quality of life, depression, opioid use, will be significantly better     in the naltrexone group compared to the non at 6-, 12-, and 18-month follow-up.      We also hypothesize that the implants can prevent death from opioid overdose up to 6 months     after commenced treatment.   "
185335|NCT00269620|"     This is an open-label prospective, multicenter, randomized trial to compare continuation     rates into the fourth cycle of women using either the NuvaRing or OrthoEvra. Five hundred     women will be recruited at 9 centers nationwide to be randomly assigned to use either the     NuvaRing or OrthoEvra for four months. Women must either be on the pill or have recently     stopped the pill and be relatively satisfied with oral contraceptive use to qualify for     enrollment. Two visits and two phone calls will be required.   "
185336|NCT00269633|"     The specific aim of this study is to test the hypothesis that light stimuli concentrated     around 467 nm will evoke a significantly stronger therapeutic response in SAD patients     compared to light stimuli concentrated around 657 nm at an equal photon density.      The secondary objective of this study is to determine the efficacy of different colors and     levels of light in order to optimize therapeutic benefit, while also minimizing side effects     and maintaining safety of light exposure.   "
185337|NCT00269646|"     The purpose of this study is to compare the effects of a low-carbohydrate diet and a     high-carbohydrate, high-fiber diet, on insulin sensitivity and blood chemicals considered     risk markers for heart disease, in persons with the metabolic syndrome.      Our primary hypothesis is that the ad libitum high-carbohydrate, high-fiber diet will     significantly improve insulin sensitivity, whereas the ad libitum low-carbohydrate, low-fiber     diet will not.   "
185339|NCT00269672|"     There is evidence that aluminum phosphate (AlPO4) contained as an adjuvant in conjugate     vaccines enhances the immune response in infants. There is no data so far evaluating whether     this also applies to adults. The objective of this study is to compare the immune response of     2 different 13-valent pneumococcal conjugate (13vPnC) formulations with and without AlPO4 to     select a formulation and to compare the immune response to the chosen 13vPnC formulation     relative to the immune response to 23-valent pneumococcal polysaccharide vaccine (23vPS).   "
185340|NCT00269685|"     The purpose of this study is to compare the classical tactics in the treatment of septic     shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice     pressor.      Vasopressin seems to be an interesting alternative in the treatment of septic shock. To this     date, available studies have showed that it could correct hyperkinetic syndrome and     vasoplegia in septic shocks without noticeable side effect. It as been demonstrated that     vasopressin improves renal function, as no effect on digestive organs and as no metabolic     effect.   "
185341|NCT00269724|"     The purpose of this study is to is to evaluate the safety and efficacy of OROS® oxybutynin     chloride in patients being treated for urge urinary incontinence. Oxybutynin is an     antispasmodic, anticholinergic medication for the treatment of the symptoms of overactive     bladder.   "
185342|NCT00269737|"     The purpose of this study is to evaluate the safety and effectiveness of continuous use of     TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the     treatment of chronic cancer pain.   "
185343|NCT00269750|"     The purpose of this study is to compare the efficacy and safety of OROS® oxybutynin to that     of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge or mixed     urinary incontinence. Oxybutynin is an antispasmodic, anticholinergic medication for the     treatment of the symptoms of overactive bladder.   "
185344|NCT00269763|"     The purpose of this study is to establish the clinical utility and safety of fentanyl TTS (a     transdermal patch delivering the narcotic pain reliever fentanyl) in the treatment of pain in     patients with cancer.   "
185345|NCT00269776|"     The purpose of this study is to provide data on the effectiveness of the OROS Methylphenidate     Hydrochloride (HCl) formulation compared to placebo and standard immediate-release Ritalin     with respect to improving attention and behavior, and decreasing hyperactivity in children     with Attention Deficit Hyperactivity Disorder (ADHD). Both OROS Methylphenidate HCl and     Ritalin contain the central nervous system stimulant, methylphenidate HCl. The safety     associated with the two methylphenidate formulations will also be compared with placebo.   "
185346|NCT00269789|"     The purpose of this study is to compare the effectiveness (onset of effect, time to loss of     effect, and overall efficacy) of methylphenidate given as an OROSÂ® (methylphenidate HCl)     formulation, compared to immediate-release RitalinÂ® and placebo for the treatment of     Attention Deficit Hyperactivity Disorder (ADHD) in children using standardized attention and     behavior scales, and other assessments. Both OROSÂ® Methylphenidate HCl and RitalinÂ® contain     the central nervous system stimulant, methylphenidate HCl.   "
185347|NCT00269802|"     The purpose of this study is to evaluate the efficacy and safety of OROSÂ® Methylphenidate     HCl as compared with placebo and standard immediate-release RitalinÂ® (taken three time per     day) for the treatment of Attention Deficit Hyperactivity Disorder in children. Both OROSÂ®     Methylphenidate HCl and RitalinÂ® contain the central nervous system stimulant,     methylphenidate HCl.   "
185348|NCT00269815|"     The purpose of this study is to evaluate the long-term safety and effectiveness of OROSÂ®     Methylphenidate HCl (a central nervous system stimulant) in children with attention deficit     hyperactivity disorder (ADHD).   "
185349|NCT00269828|"     This is a randomized, open-label, multinational, phase III study in women with     histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have     PS 2. Study drug will be administered on day 1 of each 21 day cycle   "
185353|NCT00269880|"     The purpose of this study is to compare the safety and effectiveness of abciximab, an     anti-platelet therapy, versus placebo in patients undergoing percutaneous coronary     intervention when administered in combination with two different heparin regimens. Please see     attached results.   "
185354|NCT00269893|"     The purpose of this study is to evaluate the effectiveness and safety of abciximab (an     anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty.   "
185355|NCT00269906|"     The purpose of this study is to evaluate the safety and efficacy of abciximab, an     anti-platelet therapy, versus placebo in patients with unstable angina who are not responding     to standard medical therapy and who are eligible for coronary angioplasty.   "
185356|NCT00269919|"     The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting     injectable formulation of risperidone (an antipsychotic medication) and its influence on     quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of     emotional instability, detachment from reality, often with delusions and hallucinations, and     withdrawal into the self).   "
185357|NCT00269932|"     The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an     antibiotic, compared with cefuroxime axetil, another antibiotic, in the treatment of adults     with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.   "
185358|NCT00269945|"     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus     placebo for the treatment of anemia in AIDS (Acquired Immunodeficiency Syndrome) patients     with anemia that is a result of this disease and zidovudine (AZT) treatment. Epoetin alfa is     a genetically engineered protein that stimulates red blood cell production.   "
185359|NCT00272363|"     This study will document the clinical and genetic features of glaucoma and related diseases,     including normal tension glaucoma (NTG). Researchers would like to define genetic influences     and eventually isolate the genes causing those diseases.      Glaucoma is an important cause of vision loss in the United States and worldwide. The disease     is marked by a wearing down of the retina and optic nerve, often associated with increased     pressure in the eye. It is often an inherited trait. This study will involve between 250 and     2,000 patients over a 5-year period. It will examine the natural history of the genotype, or     genetic makeup, of a person and the phenotype, that is, visible situations produced by the     interaction of the genotype and one's environment.      Patients 4 and older who have glaucoma or related diseases or whose family members have those     diseases may be eligible for this study. They will complete a medical history for the doctors     to verify the diagnosis, inquire about medical problems and surgical operations, and gather     data about vision problems in a patient's family (by drawing a family tree). The complete eye     examination may take several hours. Eye drops will be used to dilate, or enlarge, the pupils     of patients' eyes, and the pupils will stay dilated for 4 to 6 hours. There may be some     temporary glare in brightly lit areas, which can be reduced by wearing of sunglasses.     Patients may experience some blurring of vision. There may be a localized allergic reaction     to the medication used or an increase of pressure inside the eye. If that occurs, medication     to control the reaction will be given. In addition, photographs of the retina and perhaps     even the lens will be taken. For that procedure, eye drops will dilate the pupils of the     eyes. The light that is involved with the specialized photography may cause some mild     discomfort. Patients will undergo eye tests regarding color vision, field of vision, and     ability to see the dark. Also, there will be a measurement of pressure in the eye and     thickness of the cornea.      To study patients' DNA, the researchers will obtain a blood sample of about 4 teaspoons from     patients 10 years or older. A smaller amount of about 1 teaspoon for each 5 lb. of body     weight will be collected from younger patients. Those DNA samples will be used only for     research in the genetic disorder in a patient's family. No other testing or research will be     conducted on the blood samples without patients' separate permission. Also, the DNA will be     stored by codes that the researchers define and contained in a secured building.      In this study, researchers will not provide information about a patient's health to patient     family members or to other people. They will not discuss information such as adoption or     biological fatherhood unless it has medical implications for the patient or the patient's     family members.      If information obtained from this study may be important to patients' health, they will be     informed when it is available. There are no plans to give patients the results of any medical     tests, evaluations, or other research data. Further research may be needed before such     results become meaningful.   "
185360|NCT00272376|"     This study will examine the inheritance of myopia in families of various nationalities and     ethnic backgrounds to identify gene changes that cause myopia or similar diseases and to     better understand these conditions. In patients with myopia, the eye does not focus light     accurately on the retina (tissue that lines the back of the eye), so that objects at a     distance appear blurry. Myopia may occur alone, with other vision problems such as retinal     dislocations, cataract or glaucoma, or with other problems such as joint or skin problems.      People with myopia (usually those from families with several affected members) and control     subjects with normal vision may be eligible for this study.      Each participant undergoes the following procedures:        -  Blood draw for genetic testing related to the disorders under study        -  Medical and family history, including drawing a family tree to explore vision problems          in the family        -  Complete eye examination, including refraction (pupil dilation) and visual acuity          testing, photographs of the retina and possibly lens, and specialized tests to measure          field of vision, color vision and ability to see in the dark   "
186835|NCT00291083|"     To examine nipple aspirate fluid for secretions that may be identified as a high risk     indicator for development of breast cancer, and compare those to serum analysis.   "
185361|NCT00272389|"     We hypothesized that pretreatment nonresponder and responder liver tissue would show     consistent differences in gene expression levels and that these differences could be used to     predict treatment outcomes and this can obviate the need of the present therapeutic trial.We     are interested in conducting a retrospective study using the data of patients suffering from     chronic HCV infection who were treated in our department with a combination of PEGINTERFERON     and RIBAVIRIN. All these patients underwent liver biopsy prior the treatment. Based on the     clinical data available it is possible to determine the responders and nonresponders to this     therapy.RNA will be extracted from the liver tissue and the expression of 5     genes(IFI15,IFI616,IFI1,OAS3,OAS2 )will be checked .The prediction power of the combination     of these genes in differentiating responders from nonresponders will be determined.   "
185362|NCT00272402|"     In this randomized trial we evaluate two conceptually distinct but potentially synergistic     interventions designed to reduce clinical inertia in the outpatient care of adults with type     2 diabetes. The project addresses the following specific aims;      Specific Aim 1. Implement and assess two conceptually distinct but potentially synergistic     interventions to reduce clinical inertia related to control of A1c, SBP, and LDL in adults     with diabetes.        -  Hypothesis 1. Patients of physicians who receive the Cognitive Behavioral Intervention          (CBI) (Group 1) will subsequently have less Clinical Inertia than those who receive no          intervention (Group 4).        -  Hypothesis 2. Patients of physicians who receive the Office Systems Redesign          intervention (CBI) (Group 2) will subsequently have less Clinical Inertia than those who          receive no intervention (Group 4).        -  Hypothesis 3. Patients of physicians who receive the combined CBI plus OSR intervention          (Group 3) will subsequently have less Clinical Inertia than those who receive CBI alone          (Group 1) or OSR alone (Group 2).      Specific Aim 2. Assess the impact of interventions to reduce clinical inertia on health care     charges.      • Hypothesis 4. After adjustment for baseline measures of health care charges, those who     receive no intervention (Group 4), will have higher total health care charges over a 24-month     follow-up, relative to the patients of physicians in intervention Group 1, Group 2, or Group     3.   "
185363|NCT00272415|"     This is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen     (18) or older, with newly-diagnosed or recurrent unresectable Stage III or Stage IV melanoma.     A maximum of 18 subjects will be enrolled in Stage 1 of this study. (Stage 1 completed     enrollment in June 2006.) A maximum of 39 subjects will be enrolled in Stage 2 of this study.   "
185364|NCT00272428|"     It has been suggested that a low dietary intake of antioxidant vitamins and minerals     increases the incidence rate of cardiovascular disease and cancer. To date, however, the     published results of randomized, placebo-controlled trials of supplements containing     antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the     efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins     and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the     general population.   "
185365|NCT00272441|"     To evaluate current and novel therapies and management strategies for children with asthma.     The emphasis is on clinical trials that help identify optimal therapy for children with     different asthma phenotypes, genotypes, and ethnic backgrounds and children at different     developmental stages.   "
185366|NCT00272454|"     The purpose of this study is to study efficacy and safety of cilostazol use in patients with     acute ischemic stroke.   "
185369|NCT00272493|"     Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a naturally occurring substance     that is made by the body in response to infection or inflammation, and greatly improves     cellular immune responses. The purpose of this study is to evaluate the safety and     effectiveness of GM-CSF as an adjuvant to improve the immune response to hepatitis B virus     (HBV) vaccination in HIV infected individuals.   "
185370|NCT00272506|"     To evaluate current and novel therapies and management strategies for children with asthma.     The emphasis is on clinical trials that help identify optimal therapy for children with     different asthma phenotypes, genotypes, and ethnic backgrounds and children at different     developmental stages.   "
185371|NCT00272519|"     The life skills intervention model is designed to help adolescents promote their physical and     mental health through cognitive and behavioral techniques (e.g., problem solving, coping, and     communication skills) designed to help them achieve social and personal competencies used to     manage various life challenges.   "
185372|NCT00272532|"     Study objective:        -  To demonstrate, in patients with myofascial pain syndrome in cervical region, the degree          of efficacy of thiocolchicoside ointment administered to trigger point regions compared          with the trigger point injection.   "
185373|NCT00272545|"     This study will evaluate the effectiveness of a new approach to a normalization of eating     program, based on principles of cognitive-behavioral therapy, in treating women with anorexia     nervosa or bulimia nervosa.   "
185374|NCT00272558|"     The purpose is to evaluate the activity and feasibility of a two drug regimen which is partly     orally and partly intravenous in advanced pleural mesothelioma.   "
185375|NCT00272571|"     The objectives of the study are to test the hypothesis that external counter pulsation     therapy (ECPT) provides clinical benefit by improving the number and function of endothelial     progenitor cells (EPCs) in peripheral blood of patients with angina pectoris.   "
185376|NCT00272584|"     This is a 9 week, multicentre, randomized, double-blind, placebo-controlled trial with two     parallel groups. There is also an open-label extension phase of 18 weeks. Both medications to     be used in the study, clozapine and risperidone, are fully approved for the treatment of     schizophrenia.   "
185377|NCT00272597|"     The primary objective of this pilot study is to evaluate the impact of switching 30 subjects     from an existing antipsychotic to risperidone long acting on healthcare resource utilization.     The study will be a ten month open-label, 'mirror-image', pilot study. Healthcare resource     utilization during the 10 months prior to starting risperidone long acting will be     retrospectively collected for all subjects (period A) at the beginning of the study. The     utilization of direct medical resources will also be collected for 10 months after initiation     of risperidone long acting (period B). In this design the patients will serve as their own     control.   "
185378|NCT00272610|"     The objectives of this study are to evaluate the safety and efficacy of 0.5% retinol (Vitamin     A) versus it's vehicle cream in the treatment and prevention of skin aging and Bateman's     Purpura (bruising).   "
185379|NCT00272623|"     Since the first placement of a totally implantable venous access port (TIVAP) by Niederhuber     et al in 1982 its application to provide long-term central venous access has dramatically     increased. These systems have dramatically simplified the administration of chemotherapy and     parenteral nutrition as well as the repetitive collection of blood samples.      Initial retrospective studies have focused on the complications associated with different     implantation techniques. Subsequently, major attention has been payed to the comparison of     distinct types of TIVAPs. To date a variety of approved port systems are available. These     devices can be either implanted using the Seldinger technique or by venous cut-down of the     cephalic vein Despite the global use of these established implantation procedures     prospective, randomized trials directly comparing these two approaches are still lacking. So,     the choice, which technique to use is left to the surgeon's preference.      The aim of this study is to directly compare the Seldinger technique versus cephalic vein cut     down for placement of TIVAPs in respect of implantation success rate, operation time and     perioperative morbidity.   "
185380|NCT00272636|"     The purpose of this study is to determine the long-term efficacy of radiofrequency catheter     ablation in patients with chronic atrial fibrillation.   "
185381|NCT00272649|"     The purpose of this trial is to examine the safety, feasibility, immunological response, and     clinical antitumor activity of multiple administrations of dendritic cell Immunotherapeutic     to patients with newly diagnosed with metastatic kidney cancer   "
185382|NCT00272662|"     The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and     pharmacokinetics (PK) of multiple subcutaneously administered injections of peginesatide in     anemic cancer participants receiving chemotherapy.   "
185383|NCT00272675|"     Does chlorhexidine gluonate, a simple broad-spectrum antimicrobial agent with virtually no     adverse-effects lower the incidence of NI after cardiac surgery, especially with respect to     LTI and SSI?   "
185384|NCT00272688|"     An open, observational health economic study to estimate marginal cost and health     consequences of replacing conventional Parkinsons disease therapy with intraduodenal levodopa     administered continuously   "
185385|NCT00272701|"     The purpose of this study is to assess how PPI treated GERD patients with insufficient     symptom control will benefit from a change in management by providing a more efficient acid     secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to     pre-study PPI treatment.   "
185386|NCT00272714|"     The purpose of this study is to evaluate the efficacy of two doses of 4-hydroxy tamoxifen     (4-OHT) compared with placebo on the intensity of cyclic mastalgia in pre-menopausal women     with regular menstrual cycles who are not taking oral contraceptives.   "
185387|NCT00272727|"     The purpose of the study is to assess if a dialog tool can improve compliance and asthma     control in patients with asthma.   "
185388|NCT00272740|"     The primary objective of the study is to assess the activity of fulvestrant in postmenopausal     women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase     inhibitors by estimating the Clinical Benefit Rate   "
185389|NCT00272753|"     The aim is to study whether the budesonide component within the budesonide/ formoterol     combination inhaler has additive value in a model of slow onset acute asthma , namely three     AMP provocation tests performed on one day   "
185391|NCT00272779|"     The purpose of this study is to evaluate the safety, tolerability and antiviral effects of     atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV.     A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by     participants in both arms.   "
185392|NCT00272792|"     The primary objective of this trial is to evaluate the ability of Phenoptin to increase     phenylalanine (phe) tolerance in children with phenylketonuria who are following a     phe-restricted diet.   "
185393|NCT00272805|"     The purpose of this study is to compare dosing compliance between study patients taking     controlled release carvedilol once a day, and study patients taking immediate release     carvedilol (Coreg) twice a day.   "
185394|NCT00272818|"     The incidence of gastrointestinal allergy is on the rise and can be manifest in a number of     different clinical presentations. The goal of this study is to evaluate the measurement of     CD23, a protein that can be identified stool, urine, and blood, as a non-invasive marker for     use in the diagnosis and interval assessment of patients with known or suspected     gastrointerstianl allergy.      Eosinophilic esophagitis (EE) is a disorder typically found in school-age and adolescent     children, and is more prevalent in male patients. Patients with EE typically present with     symptoms of heartburn or difficulties swallowing. Blood and x-ray studies may be normal or     display non-specific findings. The diagnosis of EE rests on a combination of clinical     symptoms, and the results of endoscopic and histologic studies. There is currently no     biochemical marker that can be used to monitor disease course in these patients.      Cow milk protein intolerance (CMPI) is an allergic process affecting the distal     gastrointestinal tract in infants. As such, it often presents as diarrhea without or without     the presence of gross rectal bleeding in infants ranging in age from birth to 6 months of     age. Children display symptoms of abdominal disress including emesis, cramping, colic, or     feeding difficulties. The diagnosis is based on an appropriate clinical history and     supporting physical exam (typically normal). Treatment involves removal of the offending     dietary antigens which include cow or soy milk protein Eosinophilic crypt abscesses, or     collections of eosinophils within the intestine can also be seen.      CD23 is a protein that can be found on allergy-type white blood cells (eosinophils), as well     as on the cells that line the gastrointestinal tract. Previous studies have reported     increased levels of CD23 in infants with cow's milk allergy. CD23 is also elevated in infants     and children with allergic disease. Levels of CD23 appears to fall in conjunction with     therapy.   "
185407|NCT00272987|"     Patients will be randomised to a 1:1 ratio to receive either paclitaxel 80 mg/m2 IV weekly     for three weeks of a four week cycle, trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly IV,     and oral lapatinib 1000 mg QD or paclitaxel 80 mg/m2 IV weekly for three weeks of a four week     cycle, trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly IV plus placebo. The primary     objective of this study is to evaluate and compare time to progression (TTP). Secondary     objectives will be to evaluate and compare the two treatment arms with respect to: overall     response rates, clinical benefit, time to response, duration of response, progression-free     survival, and overall survival. The study will first enroll an open label safety cohort of 20     patients to assess the tolerability of the triplet combination.   "
185408|NCT00273000|"     The purpose of this study is to study the effect of GLP-2 on mesenteric bloodflow in healthy     adults by the use of ultrasound., it is the hypothesis that GLP-2 vil increase the bloodflow.   "
185626|NCT00266604|"     The purpose of this study is to identify patient characteristics (such as baseline seizure     frequency) that may predict effective doses of topiramate using just that one drug     (monotherapy) as initial therapy for epilepsy. Topiramate is an anti-epileptic drug that is     approved for the treatment of epilepsy in adults and children 2 years of age and above.   "
185395|NCT00272831|"     Patients with type 2 diabetes have a long duration of disease for the development of     complications. Among all complications, microangiopathic complications are major causes of     mortality and morbidity in diabetic patients. In Asia, patients with type 2 diabetes are     particularly susceptible to the development of kidney disease. Patients with diabetic kidney     disease have more adverse metabolic profiles and increased risk of having other complications     such as blindness, stroke, heart attack and nerve damage than those without. Despite     receiving the best of care, the combined event rate of death, cardiovascular disease and end     stage kidney disease in diabetic patients with renal impairment remained as high as 10% per     year.      Cilostazol reduces platelet aggregation and prevents formation of blood clots. Furthermore,     cilostazol treatment has been shown to reduce serum triglyceride concentrations and increase     HDL-cholesterol levels. In this randomized placebo-controlled, double-blinded study, the     investigators hypothesize that Cilostazol may reduce the rate of decline in renal function in     Chinese patients with type 2 diabetes and mild to moderate renal impairment. Sixty patients     will be randomised to receive either Cilostazol 100 mg twice daily or placebo for 12 months.     The effect of Cilostazol on the progression of diabetic nephropathy, as defined by rates of     decline in glomerular filtration rate, serum creatinine and urinary albumin excretion rate     will be measured. The results will provide additional insight on the management of diabetic     kidney disease which is prevalent among Chinese diabetic patients in Hong Kong.   "
185396|NCT00272844|"     The purpose of this study is to determine whether supplementation with an oil-based     cholesterol suspension will correct the biochemical abnormalities in cholesterol and its     precursors in individuals with the Smith-Lemli-Opitz syndrome.   "
185397|NCT00272857|"     Fanconi anemia (FA) is a disease that affects an individual's bone marrow. It is caused by a     defective gene in the bone marrow cells that produce various types of blood cells.     Individuals with FA may experience fatigue, bleeding, and increased infections. The purpose     of this study is to evaluate the safety and effectiveness of a gene transfer procedure in     generating new, healthy cells in individuals with FA.   "
185398|NCT00272870|"     Cure rates for patients with high grade glioma remain disappointing, in part because tumor     cells are often resistant to chemotherapy, and because using higher doses of chemotherapy     causes damage to normal blood cells. This trial is designed to try to overcome both of these     barriers. The idea is to make tumor cells more sensitive to a chemotherapy agent,     Temozolomide, by using 06Benzylguanine (06BG). In addition, patients will have a portion of     their blood cells modified by the insertion of a chemotherapy resistance gene which may help     protect blood cells from damage by the combination of the Temozolomide and 06BG.   "
185399|NCT00272883|"     In the Congenital Myopathy Research Program at Boston Children's Hospital and Harvard Medical     School, the researchers are studying the congenital myopathies (neuromuscular diseases     present from birth), including central core disease, centronuclear/myotubular myopathy,     congenital fiber type disproportion, multiminicore disease, nemaline myopathy, rigid spine     muscular dystrophy, SEPN1 and RYR1 myopathy and undefined congenital myopathies. The primary     goal of the research is to better understand the genes and proteins (gene products) involved     in muscle functioning and disease. The researchers hope that our studies will allow for     improved diagnosis and treatment of individuals with congenital myopathies in the future. For     more information, visit the Laboratory Website at www.childrenshospital.org/research/beggs   "
185400|NCT00272896|"     We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that     VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To     test this hypothesis, we performed a double blind placebo-controlled crossover study in     migraineurs and studied the effect on headache and cerebral and systemic hemodynamic     parameters.   "
185401|NCT00272909|"     This research study is designed to evaluate the safety, tolerability, and efficacy of SUN     N4057 (piclozotan) in subjects with acute ischemic stroke within 9 hours of the onset of     symptoms.   "
185402|NCT00272922|"     The purpose of this randomized study is to determine whether a type of mesh derived from a     layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus     standard surgical suture repair.   "
185403|NCT00272935|"     This is a randomized, double-blind study to compare the efficacy and safety of daily doses of     Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to     severe hot flashes in postmenopausal women.   "
185404|NCT00272948|"     The aim of this trial is to evaluate whether the prophylactic use of Defibrotide (DF) in     pediatric patients (age less than 18 years) undergoing stem cell transplantation and who are     at high risk of developing hepatic Veno-occlusive Disease (VOD) will have an impact on the     incidence and severity of the disease. Patients will be randomly assigned to one of two     treatment arms: Those allocated to the Prophylactic Arm will receive the study drug     (Defibrotide) from the day of conditioning onwards. Patients allocated to the Control Arm     will receive the study drug (Defibrotide) from the day that VOD is diagnosed.   "
185405|NCT00272961|"     The study was to determine the safe and effective dose of TBC3711 in patients with     uncontrolled high blood pressure while already taking blood pressure medications.   "
185406|NCT00272974|"     The study was designed to measure the effects of male and female condom promotion on STI     prevalence and reported condom use by sex workers and their partners. It also examined     whether the intensity of the education and support given to intended users affected adoption     and sustained use of these methods.      The primary objective of the study was:        1. To test the effect of supplementing community-based male and female condom promotion          with clinic-based counseling, measured in terms of the level of protection in high-risk          sex acts and STI prevalence.           Secondary objectives of the study included:        2. To monitor short- and medium terms changes in the proportion of protected sex acts among          commercial sex workers after the female condom is added to a male condom distribution          system.        3. To examine short-term and medium-term changes in STI prevalence when the female condom          is added to the male condom distribution system.        4. To measure the incremental cost-effectiveness of adding female condom promotion to          existing male condom distribution systems   "
185451|NCT00273559|"     The purpose of this study is to compare the risks and benefits of steroid elimination versus     steroid therapy in renal transplant patients particularly looking at the effects on bone     mass, lipids, hypertension, and new onset diabetes.   "
185409|NCT00273013|"     This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect     on a model of asthma type inflammation called the allergen-induced late asthmatic response.     This will be compared with the response after treatment with a dummy (placebo) and a tablet     treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3     treatments in a random order. The study is double-blind so subjects will not know which     treatment they are taking at any given time.   "
185410|NCT00273026|"     This study will compare patients treated with a marketed medication and those who continue     with their usual care to assess the proportion of patients achieving well controlled asthma     after 24 weeks.   "
185411|NCT00273039|"     The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in     subjects with Social Anxiety Disorder   "
185412|NCT00273052|"     This study was designed to determine whether treatment with COREG MR is more effective at     maintaining a better lipid profile than treatment with TOPROL-XL for hypertension.   "
185413|NCT00273065|"     The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in     humans   "
185414|NCT00273078|"     This research is about tongue’s pressure during speech, using a complete denture which allows     respecting tongue and speech physiology at the best.      A strain gauge transducer is placed inside this prosthodontics device. During speech, the     pressure and the sounds are recording. The analysis of the twos signals should explain what     pressure is needed for what sound. The comparison between old complete denture wearers and     new one is realized to provide informations about tongue adaptation’s phenomenon.   "
185415|NCT00273091|"     Detektion and Registration of Atrial Tachyarrhythmias at Patients with Heart Failure; What     proportion of patients with CRT-therapy are affected at least temporarily by Atrial     Arrhythmia?   "
185416|NCT00273104|"     This follow up study (>1 year) aims to compare the effects of lifestyle intervention and     gastric by pass surgery on various comorbidities associated with morbid obesity.   "
185417|NCT00273117|"     Two groups of patients were randomised into two groups of either transnasal gastroscopy or     conventional type gastroscopy (n=98). The aim of the study was to evaluate the     cardiorespiratory effects and sideeffects of the two methods, and to evaluate the technical     features of the transnasal endoscope.   "
185418|NCT00273130|"     Sixty patients scheduled for upper diagnostic gastroscopy were randomised after written     informed consent into three groups.        1. transnasal gastroscopy with thin endoscope        2. transoral with thin endoscope        3. standard size trans-oral endoscopy Stress response parameters (epinephrine,          nor-epinephrine and cortisol, heartrate variability data and pulse oximetry data were          monitored.   "
185419|NCT00273143|"     This study is being done to determine how the body fights off a common virus known as     Cytomegalovirus (CMV). CMV is a virus that commonly infects humans and causes disease in     patients with compromised immune function such as those who receive organ and tissue     transplant. By knowing how the human body responds to the infection, researchers will be able     to develop better methods on how to prevent this infection.   "
185420|NCT00273156|"     The novel and exploratory nature of this intervention relates to the concept of incorporating     patient-specific oral health information obtained during a dental hygiene visit into the     tobacco quitline counseling. Linking the patient-specific oral health information obtained     during the dental hygiene visit to the tobacco quitline counseling will close the therapeutic     loop for oral health professionals and make them a focal point for the tobacco use     intervention without increasing clinical burden.   "
185421|NCT00273169|"     Evaluate correlation between the values from the PSA monitor and clinical assessment of     sedation with the RASS on postoperative patients.   "
185422|NCT00273182|"     Heart failure is a progressive disease that decreases the pumping action of the heart. This     may cause a backup of fluid in the heart and may result in heart beat changes.      When there are changes in the heart beat sometimes an implantable heart device is used to     control the rate and rhythm of the heart beat. In certain heart failure cases, when the two     lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization     therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted)     under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right     and left ventricles through three or four leads (soft insulated wires) that are inserted     through the veins to the heart.      The purpose of this study is to monitor the long-term performance of the InSync Model 8040     (InSync) and InSync III Model 8042 (InSync III) systems for cardiac resynchronization therapy     (CRT).   "
185423|NCT00273195|"     People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating,     may be in need of an electronic device called an implantable cardioverter defibrillator     (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it     sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm.      The purpose of this study was to evaluate the safety and efficacy of the EnTrust ICD device.     A feature of this device allows it to send small, painless electrical impulses     (Anti-tachycardia pacing or ATP) to the heart instead of shocking it out of a rhythm that is     too fast. Stopping a dangerous heart rhythm this way does not cause any pain whereas a shock     to the heart can feel like a punch in the chest. This device also allows the heart to beat on     its own when it can and helping it (by pacing, or sending it electrical signals) when it     needs help. This feature is important because previously studies have shown that pacing the     heart too often can increase the risk for heart failure or for atrial fibrillation (having     too rapid of heart beats in the atrium).      This study is now complete and the device has since been approved by the FDA.   "
185452|NCT00273572|"     The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to     increase leisure-time physical activity and reduce body weight will improve the parameters of     the metabolic syndrome and quality of life among obese, non-diabetic Arab women   "
185453|NCT00273585|"     The purpose of this study is to determine whether a newly developed educational software     program is effective in increasing patients' confidence in their ability to undergo colon     cancer screening. If the software is effective in this regard, the study will also determine     if increased confidence to undergo screening leads to more people being screened and to     people feeling as though their decision about screening was informed.   "
185424|NCT00273208|"     This research project is being done to design and then test whether a 10 week program can     help reduce the symptoms of being tired and fatigued among women who have had breast cancer.     The pilot study will include 4 groups of women, two groups of women from Baltimore and two     groups of women from Washington County, Maryland. Each group will have 5 to 6 women. The     purpose of this pilot study is to help us find the best things to include in the program to     help women who have had breast cancer and who have severe problems with fatigue that has     lasted months to years after being treated with chemotherapy or radiation therapy.      Following the pilot program we will conduct and evaluate (using a quasi-experimental design     comparing fatigue scores before and after the intervention) the efficacy of the refined     10-week integrated mind/body medicine approach to reduce symptoms of fatigue among breast     cancer survivors who have completed their adjuvant therapy. Four intervention groups (~12     women per group) will be conducted: two in the urban setting and two in the rural setting. We     will assess fatigue symptoms at baseline, immediately after the program, 2 months and 6     months following completion of the program. We will compare mean baseline scores to     post-intervention scores.      The ultimate goal is to develop a non-pharmacologic, holistic, low risk intervention for     improving symptoms of fatigue and thus improving quality of life among breast cancer     survivors   "
185425|NCT00273221|"     The aim of this study is to compare the effectiveness and safety of combined     phacoemulsification, posterior chamber intraocular lens implantation , trabeculectomy     (phacotrabeculectomy) with phacoemulsification, intraocular lens implantation and glaucoma     drainage device(phacotube) in the early and intermediate control of intraocular pressure(IOP)     in patients with primary open angle and angle closure glaucoma.   "
185426|NCT00273234|"     The purpose of this study is to compare the effectiveness of standard venous ulcer care to     standard venous ulcer care plus a cell based product made from the patients own blood. This     product, Autologous Platelet Concentrate (APC), is a concentrate of cells in the bloodstream     called platelets.   "
185427|NCT00273247|"     We conducted a randomized controlled trial of adjuvant interferon (IFN) therapy in patients     with hepatitis-C virus (HCV)-related cirrhosis who underwent curative resection of     hepatocellular carcinoma (HCC) to investigate whether IFN could reduce or delay the incidence     of recurrent tumor (secondary/tertiary prevention of HCC). Patients were randomly assigned to     treatment with IFN (3MU thrice/wk /48 weeks) vs. no treatment after curative resection of     HCC(control group)   "
185428|NCT00273260|"     The purpose of this study is to determine whether giving women feedback concerning their bone     mineral density, combined with either an information leaflet or group education concerning     osteoporosis changes women's behavior and/or bone density.   "
185429|NCT00273273|"     The purpose of this project is to study the pharmacokinetics of a once-daily antiretroviral     medication used to treat adolescents and young adults with HIV infection.   "
185430|NCT00273286|"     This is a multi-center, randomized controlled trial to test whether a clinic-integrated, low     intensity, multi-component behavioral intervention is effective in preventing the     deterioration in glycemic control, treatment adherence, and quality of life that commonly     occur during late childhood and early adolescence in youth with type 1 diabetes. The study     will also examine mechanisms and processes that influence the effectiveness of family     management of diabetes during this developmental period.   "
185431|NCT00273299|"     The purpose of this study is to assess the potential of using valsartan/HCTZ as initial     therapy in patients with severe hypertension compared to valsartan alone as initial therapy,     and to determine whether a greater proportion of patients achieve blood pressure control with     the combination compared to the monotherapy without producing an unacceptable adverse event     profile.   "
185432|NCT00273312|"     This study will evaluate the safety, efficacy, and activity of patupilone in patients with     advanced unresectable and/or metastatic hepatocellular carcinoma based on tumor response     using modified RECIST criteria.   "
185433|NCT00273325|"     Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents     the invasive disease from Streptococcus pneumoniae in full-term infants, but was not     thoroughly studied in premature infants. This study evaluated the effectiveness and safety of     the vaccine given in routine practice to very low birth weight infants, looking at blood     antibody levels 4-6 weeks after the final vaccine dose, and adverse events, survival,     infections, and neurodevelopmental outcomes at 18-22 months corrected age.   "
185434|NCT00273338|"     The primary objective of this study is:        -  To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on          survival in metastatic androgen-independent prostate cancer      The secondary objectives of this study are:        -  To determine the effect of the ASCENT regimen on the rate of thromboembolic events          (blood clots)        -  To determine the effect of the ASCENT regimen on prevention of skeletal-related events          (fractures)        -  A Separate sub-study will be conducted at selected study sites in North America to          determine the population PK of DN-101.   "
185435|NCT00273351|"     Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by     rigidity, bradykinesia, postural instability, and tremor. Clinical decline reflects ongoing     degeneration of dopamine-containing neurons. A critical unmet need for clinical research is     to improve early detection of these diseases by developing tools to assist with earlier     diagnosis. Biomarkers are broadly defined as characteristics that are objectively measured     and evaluated as indicators of normal biological processes, pathogenic processes, or     pharmacologic responses to a therapeutic intervention (Biomarkers Defintions Working Group     2001). Development of reliable biomarkers for PD would dramatically accelerate research on PD     etiology, pathophysiology, disease progression and therapeutics. Specific biomarkers may be     useful at the onset of neurodegeneration, the onset of disease, and/or to mark disease     progression. The biomarkers in this study include brain imaging with a radioactively labelled     drug (Beta-CIT), computerized testing of memory, attention, motor speed, judgment and     handwriting, and assessments of speech and smell. Subjects may also be asked to provide a     blood sample for genetic and biochemical testing.   "
185454|NCT00273598|"     Idiopathic scoliosis affects 2-5% of adolescents. This study will compare the quality of     life, functional outcome, cosmetic result, and the correction of spinal deformity of two     instrumentation systems for the treatment of adolescent idiopathic scoliosis.   "
185436|NCT00273364|"     Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases,     it starts as a relapsing-remitting disease with distinct attacks and no symptoms between     flares. Over years or decades, virtually all cases transition into a progressive disease in     which insidious and slow neurologic deterioration occurs with or without acute flares.     Relapsing-remitting disease is often responsive to immune suppressive or modulating     therapies, while immune based therapies are generally ineffective in patients with a     progressive clinical course. This clinical course and response to immune suppression, as well     as neuropathology and neuroimaging studies, suggest that disease progression is associated     with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune     mediated demyelination. Therefore, immune based therapies, in order to be effective, need to     be started early in the disease course while MS is predominately an immune-mediated and     inflammatory disease. While current immune based therapies delay disability, no intervention     has been proven to prevent progressive disability. We propose, as a randomized study,     autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG     versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone,     natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite     treatment with alternate approved therapy.   "
185437|NCT00273377|"     The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen     reduce wound infection risk in patients undergoing colon resection. The investigators will     simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for     postoperative nausea and vomiting) does not increase infection risk.   "
185438|NCT00273390|"     This project is designed to test the hypothesis that inhibition of binding between tumor     necrosis factor alpha (TNF-alpha) and its receptors using Remicade (infliximab, chimeric     mouse/human IgG1K monoclonal antibody directed against human TNF-alpha, Centocor, Malvern,PA)     is clinically useful for patients with uveitis that is refractory to other forms of systemic     immunosuppressive therapy.   "
185439|NCT00273403|"     This outcome evaluation effort provides the opportunity to learn what programmatic approaches     effectively address two of the most difficult hurdles in HIV health services delivery: (1)     getting people who would benefit from health care to use it and (2) getting people who do use     health care to do so more consistently and effectively. The New York HIV Planning Council     (through MHRA) has funded 23 agencies to achieve these objectives for people of color with     HIV disease.   "
185440|NCT00273416|"     The primary aim of this study is to assess how effective PF-00592379 is in restoring penile     erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits     where they will receive the following in random order; 2 separate doses of PF-00592379,     sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on     penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM     technique).   "
185441|NCT00273429|"     To compare the 24-hour efficacy and safety, measured every three hours, of the     dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each     given once daily.   "
185442|NCT00273442|"     To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol     maleate fixed combination because they are insufficiently controlled on latanoprost     monotherapy.   "
185443|NCT00273455|"     To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed     combination given twice daily versus bimatoprost given once every evening in patients with     open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy   "
185444|NCT00273468|"     To study the safety and effectiveness of a granisetron patch to treat Chemotherapy-Induced     Nausea and Vomiting (CINV)   "
185445|NCT00273481|"     To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus     the LTFC given once every morning following a run-in period with timolol maleate given twice     daily.   "
185446|NCT00273494|"     Hypothesis is that surgery is of benefit in locally advanced NSCLC with N2 disease.      Patients are randomised to surgery or not.   "
185447|NCT00273507|"     Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC     (IB, IIA, IIB, and IIIA/N2).   "
185493|NCT00274118|"     To compare the renal consequences of two different approaches to blocking the renin     angiotensin system in subjects with hypertension and concurrent Type II diabetes mellitus and     diabetic nephropathy.   "
185494|NCT00274131|"     To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI     Sifrol®) in Parkinson's disease (phase III study).   "
185448|NCT00273520|"     Primary Objective:        -  The primary objective is to evaluate the clinical efficacy of telithromycin versus          placebo as a supplement to the usual standard of care during an acute exacerbation of          asthma. Efficacy will be assessed by:             -  Changes in the diary card summary symptom score assessed daily for 6 weeks, and             -  Changes in the domiciliary morning Peak Expiratory Flow Rate (PEFR) following oral               telithromycin treatment      Secondary Objectives:      The secondary objectives of the study are:        -  To evaluate the microbial activity of telithromycin during an exacerbation of asthma by:             -  Assessment of the patient's clinical improvement relative to initial C. pneumoniae               or M. pneumoniae status, and             -  Analysis of the quantitative changes from baseline in C. pneumonia or M. pneumoniae               by culture and quantitative Polymerase Chain Reaction (PCR).        -  To evaluate the safety of 10 days of oral telithromycin as a supplement to the standard          of care for patients with acute exacerbations of asthma        -  To assess additional efficacy endpoints and health outcome evaluations following 10 days          of treatment with either oral telithromycin or placebo, with either treatment used as a          supplement to the standard of care for patients with acute exacerbations of asthma:             -  Changes and daily variability in the PEFR during the 6 weeks of study treatment,             -  Health status at follow-up (6 weeks)             -  Pulmonary function tests:                  -  Forced Expiratory Volume in 1 second (FEV1)                  -  Forced Vital Capacity (FVC)                  -  Forced Expiratory Flow Rate (FEF25-75%)             -  Need for additional medications (e.g., inhaled corticosteroids, oral               corticosteroids, bronchodilator use),             -  Time to next acute exacerbation of asthma.   "
185449|NCT00273533|"     The present study is designed to evaluate the hypothesis that the Angiotensin‐Converting     Enzyme (ACE) inhibitor Ramipril improves vascular function and reduces markers of low-grade     chronic inflammation and oxidative stress in patients with Rheumatoid Arthritis.   "
185450|NCT00273546|"     -  1.To compare overall survival after treatment with the test tri-therapy (TPF: docetaxel          plus cisplatin and 5FU) or the control treatment (PF: cisplatin plus 5-FU) followed by          chemoradiotherapy in patients with locally advanced SCCHN.        -  2.The main secondary endpoint is progression free survival (PFS). The other secondary          endpoints are to evaluate and compare improvement of local symptoms; time-to-treatment          failure; quality of life; clinical complete response rate (CR and CR/PR); toxicity and          to evaluate the relationship of tumor markers and response to therapy.   "
185455|NCT00273611|"     Vitamin D is important to maintain good health. Although it is found in foods and vitamins,     many people still have low vitamin D levels. One purpose of this study is to describe vitamin     D levels from patients at the University of Colorado Seniors Clinic. Another goal of the     study is to find out if education by a pharmacist can increase vitamin D levels in patients     who have low vitamin D levels.   "
185456|NCT00273624|"     60 patients with major depression will be treated with 10 mg Olanzapine or Placebo for 2     weeks. In case of response (reduction of depressive symptoms)the study will be continued for     further 60 days.   "
185457|NCT00273637|"     The goal of this study is to better characterize peripartum cardiomyoapthy or     pregnancy-related cardiomyopathy by enrolling as many PPCM survivors as possible using both     direct and web-based methods of recritment. Patients will anser a questionnaire regarding the     onset, progression, treatment and follow-up of their diagnosis as well as the psychosocial     aspects of PPCM.   "
185458|NCT00273650|"     We will be testing a specific dietary supplement, methylcobalamin (vitamin B12). Follow-up     assessments with our clinical team will take place over the 12-week study period so that we     can record any changes in development. The main goal of this study is to determine if     subcutaneous injections of vitamin B12 given every three days can positively affect behavior     and development in children with autism.      Hypothesis: Methylcobalamin injections will improve measures of executive function, speech,     and socialization in children with autism, and will be associated with metabolic improvement.   "
185459|NCT00273663|"     Direct stimulation of the cerebral cortex induces an increase in cerebral blood flow.     Although this information is known, it has never been documented during Transcranial Cerebral     Electrical Stimulation (TCES), which is a non invasive technique. It is used to modulate the     opiate endogenous system, mainly in opioid users but no cerebral blood flow mapping of the     anatomic regions involved in this modulation of the opiate system under electrical     stimulation has been performed in functional Computerized Tomography.   "
185460|NCT00273676|"     Patients with severe community-acquired pneumonia are included Half of the patients are     treated with a 3 day course of intravenous antibiotics, followed, when clinical stable, by a     course of oral antibiotics. Efficacy of this treatment is compared to a standard course of 7     days of intravenous antibiotics, which treatment is assigned to the other half of patients.     Outcomes measured are clinical cure and costs.   "
185461|NCT00273689|"     The purpose of the study is to test how well 2 different medications stop asthma symptoms     caused by exercising. The two medications that will be tested are pretreatment with     albuterol and montelukast (Singulair®). Although both medications are used for treating     asthma, we don't know which medicine is better at stopping asthma symptoms caused by     exercising.   "
185495|NCT00274144|"     Effects of AT1 receptor antagonist telmisartan on the primary endpoint inflammatory     parameters in patients with coronary artery disease (CAD). Secondary endpoints are     alterations in clinical course and blood pressure   "
185496|NCT00274157|"     The specific aims of the project are as follows:      To determine whether catheter-based revascularization procedures improve functional capacity     and quality of life among patients with intermittent claudication.      To investigate whether improvements in walking ability result in a less sedentary lifestyle     and improvement of the cardiovascular risk profile.   "
185497|NCT00274170|"     : Headaches are a common complaint presenting to the emergency department (ED), accounting     for 1-2% of all ED visits, with migraines as the second most common primary headache     syndrome. Patients that ultimately present to the ED have failed outpatient therapy and     exhibit severe and persistent symptoms. Treatment options have been traditionally with a     parenteral opiod, generally Demerol. Unfortunately, patients with chronic painful conditions     like migraines have been prone to dependency. In 1986, a nonopioid, compazine was noted     serendipitously to relieve migraine headache pain. 1 Nonopioid regimens have evolved as     standard therapy in the treatment of migrainne headache in the ED. Today, there are a number     of nonopioid treatment options, but not without their own individual concerns. Ergotamine and     dihydroergotamine are effective, but commonly cause nausea and vomiting. Sumatriptan is     expensive has recurrence rate, is ineffective in about 20-30%, and is contra-indicated in     patients with cardiac disease. Metoclopramide, a dopamine receptor antagonist, commonly used     as an anti-emetic agent, has been widely studied for use with acute migraines. Its side     effects include drowsiness and dystonic reactions. Compazine has been successfully used to     treat migraine headaches for the past several decades, and has been accepted as standard     treatment of headaches in the ED. 2 Its side effect profile includes extrapyramidal effects,     dysphoria, drowsiness and akathisias. The ideal medication for treating headaches would have     no addictive properties, few side effects, quick onset, be highly effective and have a low     rate of recurrence. Somatostatin is known to have an inhibitory effect on a number of     neuropetides, which have been implicated in migraine. Native somatostatin is an unstable     compound and is broken down in minutes, but octreotide, a somatostatin analogue has a longer     half life. Intravenous somatostatin has been shown to be as effective as ergotamine in the     acute treatment of cluster headache. 3 The analgesic effect of octreotide with headaches     associated with growth hormone secreting tumor has been established. 4 Five somatostatin     receptors have been cloned with octreotide acting predominantely on sst2 and sst5. The     distribution of sst2 within the central nervous system strongly suggests that this particular     somatostatin receptor has a role in cranial nociception, being highly expressed in the     trigeminal nucleus caudalis and periaqueductal grey. Kapicioglu et.al performed a double     blind study comparing octreotide to placebo in treating migraine. They found there to be a     significantly greater relief of pain with octreotide at 2 and 6 hours compared to placebo     (76% vs 25%, p<0.02). They noted that 47% of those in the octreotide group had complete     relief compared to no patients in the placebo group. They went on to note that those patients     in the octreotide group had earlier relief of symptoms and no side effects. The only minor     adverse event related to the administration of octreotide was a local reaction in 3 patients     (18%). In a study performed recently in Netherlands, no clinically relevant changes in vital     signs, routine chemistry, and urinalysis were observed with octreotide use. Electrocardiogram     analyses showed no newly occurring or worsening of known cardiac abnormalities 2 and 24 h     after injection with octreotide. 5 Levy et. al also compared octreotide to placebo in a     double blinded study but found no difference. This was a poorly designed study, in that the     patients treated themselves at home with an injection of either placebo or octreotide for 2     episodes of headache and recorded their level of pain relief at 2 hours. Matharu et. al also     performed a double blind study comparing octreotide to placebo, but looking at cluster     headaches rather than migraines. They found there to be a significant improvement with the     use of octreotide over placebo (52% vs 36%). At Darnall Army Community Hospital the cost of     100 mcg Octreotide and10 mg Compazine, is $10.46, $2.02-8.00, respectively.   "
190992|NCT00339066|"     This study will determine the relationship between brain lesion severity, treatment response,     and frontal lobe brain function in people with late-life depression (LLD).   "
185462|NCT00273702|"     After completing all screening evaluations, subjects will receive unblinded N-Acetyl Cysteine     600 mg/day for 2 weeks. The dose will be raised to 1200 mg/day at visit 4 and to 1800 mg/day     at visit 6 unless clinical improvement has been attained at a lower dose (clinical     improvement will be assessed by the investigator with respect to gambling thoughts, urges and     behavior). If it is clinically necessary to modify this schedule (e.g., because of side     effects or an adequate response to a lower dose), the dose will be raised more slowly or the     target dose will not be reached.      Subjects will start no other psychotropic medications during the study but may continue on     previously prescribed psychotropic medications if on a stable dose for 3 months prior to     study entry. Psychotherapy of any form (including cognitive-behavioral therapy) will not be     initiated during the study but subjects may continue with current psychotherapy if they have     been undergoing therapy for at least three months prior to study entry.      Subjects will be evaluated with the PG-YBOCS, G-SAS, CGI, HAM-D, HAM-A and the Sheehan     Disability Inventory at screening and at each visit for the remainder of the study.     Medication side effects will be evaluated at each study visit. A tablet count will be kept     for each dose of medication taken.   "
185463|NCT00273715|"     Skin closure either by sutures or staples is required after any surgical procedure of the     hip.      The purpose of this study is to compare the amount of drainage between patients who have had     either staples or sutures placed for skin closure.   "
185464|NCT00273728|"     Background: In patients with severe sepsis and septic shock early aggressive volume     replacement reduced mortality. Standard infusion therapy consists of crystalloid infusions.     The role of modern, low molecular weight, starch preparations and their influence on the     course of disease is not determined yet.      Hypothesis: The purpose of this study is to determine wether initial infusion therapy with     Hydroxyethylstarch and Ringer's lactate reduces in septic patients reduces Intensive Care     Unit and hospital length of stay without impairment of renal function      Design: Double-blind, randomized, controlled monocentric study      Setting: Intensive Care Units of a University Hospital      Patients: 240 consecutive patients with sepsis, severe sepsis and septic shock      Intervention: Volume therapy with Ringer's lactate and saline or hydroxy-ethyl starch (MW     130, substitution 0.4) in the first five days of intensive care treatment.      Parameter:        -  Intensive Care length of stay        -  Hospital length of stay        -  Mortality        -  Kidney function      Statistics: Mann-Whitney test for non-parametric data like intensive care length of stay.     Unpaired t-Test for kidney function parameters.      Study withdrawal: Significant impairment of kidney function parameters in the hydroxy-ethyl     starch group   "
185465|NCT00273741|"     The aim/objective of this study is to evaluate the antiasthenic effect of methylphenidate     with a visual analogical scale (VAS) after 7 days of treatment, in cancer patients, in     palliative care, i.e. with a progressive or terminal disease.   "
185466|NCT00273754|"     This is a research study using caffeine in children who have an obstructive sleep apnea     (OSA). OSA means children who stop breathing during their sleep due to obstruction in their     airway. The purpose of this study is to determine whether caffeine when given in the vein,     will wake children up faster and decrease post-anesthesia airway obstruction, as well as the     safety and if the drug agrees with the child compared to a placebo (an inactive or dummy     agent).   "
185467|NCT00273767|"     The main objective is to observe the effects of erythropoietin administration on different     blood markers of ischaemic cardiac lesions induced by cardiopulmonary bypass.   "
185468|NCT00273780|"     This study proposes a 4-armed factorial randomized clinical trial in Nairobi, Kenya to     determine the effect of cognitive and behavioral interventions on HAART adherence.   "
185469|NCT00273793|"     Incentives can be used to facilitate the acquisition of many healthy behaviors, such as     smoking cessation. However, there is much room for improvement in the use of incentives. This     study investigates how two aspects of providing incentives influence the effectiveness of     using incentives to promote smoking cessation. One aspect is the criterion for providing     incentives, e.g., whether to require smoking cessation before providing an incentive or to     provide incentives following smoking reductions. The other aspect being investigated is     whether it is best to use a fixed incentive amount or an amount that increases with continued     cessation success.   "
185470|NCT00273806|"     The purpose of the study is to determine whether a program of screening and intervention for     four health risk behaviors (smoking, problem drinking, sedentary lifestyle, unhealthy diet)     carried out by medical assistants in primary care practices can help patients improve their     behaviors. The hypothesis is that patients who receive the intervention will demonstrate     higher rates of health behavior change than patients who receive usual care.   "
185471|NCT00273819|"     The purpose of this study is to test the ability of a new X-ray technique called CT     angiography to identify significant narrowing of the coronary arteries compared to     traditional coronary angiogram.   "
185472|NCT00273832|"     The purpose of this study is to determine whether coronary artery computed tomography     scanning is a more rapid, less expensive and safe alternative to standard diagnostic     evaluation of patients with acute chest pain in the emergency room.   "
185473|NCT00273845|"     The broad goal of this study is to assess the effectiveness of two interventions to     facilitate treatment linkage and treatment engagement. Treatment linkage is operationally     defined as completion of agency intake procedures and attendance at the first clinical or     therapy session. Treatment engagement represents a more comprehensive conceptualization of     treatment retention and includes measures of the clinical and ancillary services actually     received by the client over time; as such, client engagement focuses on the intensity and     duration of treatment participation. This study will enhance the CIU concept by conducting a     controlled trial, using a three-armed research design, of interventions designed to enhance     treatment linkage and treatment engagement. These interventions - a Motivational Intervention     and Strengths-Based Case Management - are science-based and have demonstrated efficacy in     moving drug abusers towards treatment and supporting treatment engagement.   "
185474|NCT00273858|"     This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety     of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or     50mg of etanercept once weekly. The improvement of health-related quality of life will also     be evaluated.   "
185477|NCT00273897|"     This study will test whether DC electrical polarization of the brain can temporarily improve     hand function in patients with corticobasal syndrome (CBS). In this degenerative disorder of     the brain, nerve cells die over time, causing a progressive decline in the patient's ability     to use their hands. This is always worse on one side. Other symptoms include arm or leg     stiffness, tremor, gait unsteadiness, and speech difficulty. Some patients also have some     decline in thinking ability, such as loss of skilled activities, poor problem solving     abilities poor concentration, problems with language, and forgetfulness,. DC electrical     polarization of the brain involves placing sponge electrodes on the head and passing a very     weak current between them. DC polarization can temporarily improve the ability of healthy     people to make word lists and may improve symptoms in some brain diseases.      Patients 40 and older with CBS who have participated in NINDS protocol 02-N-0001 (Testing a     Model of the Representational Knowledge Stored in the Human Prefrontal Cortex) may be     eligible for this study. In protocol 02-N-0001, participants provide a medical history,     undergo a neurological examination, PET scanning and MRI, and complete tests, such as sitting     in front of a computer monitor and press a key to indicate a decision about what appears on     the screen (for example, whether a statement is accurate) and answering questions from a test     examiner.      For the current protocol, participants have three 2-hour testing sessions at the NIH Clinical     Center, scheduled at least one day apart. In each session, sponge electrodes are placed on     the head so that they affect different areas of the brain. Two areas are involved with hand     movement; the third does not. The electrodes are dampened with water and attached to the     sides of the patient's head. When the current is turned on, the patient may feel some     tingling. The current is on for 40 minutes, but can be reduced or stopped early if the     tingling becomes uncomfortable.      Before and during each session, the patients' hand function is tested by having them perform     and imitate some actions, insert pegs into holes on a board, and tap their index finger as     fast as they can. Part or all of the sessions are videotaped for use in evaluating the     effects of DC polarization.   "
185478|NCT00273910|"     This study will evaluate the immunization effects of a vaccine for patients who are at risk     for recurrence of their skin cancer. That is, the risk of cancer is higher if melanoma has     invaded deep into the skin or lymph nodes. Currently, the only therapy that the U.S. Food and     Drug Administration (FDA) has approved for preventing recurrence of melanoma is     alpha-interferon. But the research data are controversial. In this study, the vaccine to be     used, called gp100, contains a piece of a protein called a peptide, which melanoma cancer     cells produce.      Patients 16 and older who have had confirmed melanoma surgically removed and whose tissue     type is tested as being human leukocyte antigen serotype within HLA-A serotype group     (HLA-A2), through a specific blood test, may be eligible for this study.      Up to 132 participants will be enrolled. There will be a physical examination and collection     of blood samples for tests, and making sure that x-rays and scans are current. Patients will     be randomly assigned to four groups. Group 1 will receive the peptide with an adjuvant     (assistant) oil-based liquid called Montanide ISA-51, as an injection in the thigh. Group 2     will receive gp100, Montanide, and a cream called imiquimod, which the FDA has approved for     treating genital warts and herpes but that may help immune cells in the skin to recognize the     vaccine. Imiquimod will be applied to the skin for 5 days. Group 3 will receive gp100 mixed     in salt water given as several mini-doses under the skin of the thigh. Group 4 will also     receive several mini-doses of gp100 mixed in saline, as well as imiquimod cream applied to     the skin for 5 days. All patients will receive the gp100 every 3 weeks for 12 weeks. Every     dose is a cycle, with four cycles considered a course of therapy. If the melanoma does not     return or patients do not experience side effects from this therapy, then the courses of     vaccine will repeated for up to 12 cycles of therapy (3 courses over 33 weeks). Side effects     of the peptide vaccination include local swelling, swelling of local lymph nodes, bruising,     and pain and redness at the injection sites. There may be chills or fever. Patients will be     watched closely for such side effects.      To study how the vaccine changes the action of cells in the immune system, patients' white     blood cells (lymphocytes) will be obtained, involving a separate informed consent. The     procedure, called leukaphersis, requires inserting a needle into the arm, to obtain blood     going into a machine, which divides the blood into red cells, plasma (or the serum part), and     lymphocytes. The lymphocytes are removed, and the plasma and red cells returned to the     patient through a second needle in the other arm. Risks associated with the procedure include     fainting, which can be prevented by patients' eating before coming to the lab, and bleeding     and infection at the needle site. Patients will undergo leukapheresis will be done about four     times: before receiving the vaccine, 3 weeks after the first four doses, and then after 8     cycles and 12 cycles. Patients assigned to the groups receiving imiquimod will be asked to     record every time they apply that cream and describe any symptoms developed during the study.     All patients will be watched closely for any sign that their melanoma has returned. Before     and throughout the study, multiple blood tests will be conducted.      The vaccine, Montanide, and imiquimod may increase patients' immune system in fighting off     new tumors, but that is not known now. However, the study may provide information that will     be useful in treating melanoma patients in the future.   "
185479|NCT00273936|"     The purpose of this study is to determine the safety and maximum tolerated dose,     pharmacokinetics, and anti-neoplastic response of AVN-944 in patients with advanced     hematologic malignancies.   "
185480|NCT00273949|"     The purpose of this study is to assess the ability of lactulose, a prebiotic agent, to     prevent hospital acquired infection in children   "
185481|NCT00273962|"     To compare the bronchodilator efficacy of ipratropium plus salbutamol (Combivent) with     salbutamol alone given every 20 minutes for three doses in asthmatic children with severe     acute exacerbation   "
185482|NCT00273975|"     Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and     nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when     administered for 48 weeks in antiretroviral drug naïve paediatric patients.   "
185483|NCT00273988|"     The purpose of this study was to determine the effects of nevirapine treatment on the     pharmacokinetics of methadone in HIV-1 infected, opioid-dependent adults who had been on a     stable methadone maintenance therapy for at least five days prior to study entry.   "
185484|NCT00274001|"     The purpose of this trial is to compare the effect of switching to nevirapine     (Viramune®)-containing regimen on quality of life of patients with fat abnormalities and     virological control whilst receiving a PI-based regimen.   "
185686|NCT00275925|"     This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine     monotherapy in adults with partial seizures.   "
185485|NCT00274014|"     The objectives of this study were to evaluate the effect of a one-year treatment with inhaled     tiotropium bromide 18 mcg once daily on lung function, incidence and severity of     exacerbations in patients with chronic obstructive pulmonary disease (COPD).      The secondary purpose was to explore possible relationships between lung function changes and     occurrence of COPD exacerbations and to try to characterize these exacerbations.   "
185486|NCT00274027|"     To explore the mechanisms of dyspnea relief during exercise in patients with COPD following     treatment with tiotropium bromide (Spiriva)   "
185487|NCT00274040|"     Comparison of 18 mcg of Tiotropium Inhalation Capsules and ipratropiumMetered Dose Inhaler (2     puffs of 20 mcg, four times daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study     in Adults with Chronic Obstructive Pulmonary Disease (COPD).      The objective of this study is to compare the bronchodilator efficacy and safety of     tiotropium inhalation capsules (18 mcg once daily) and ipratropium MDI (2 puffs of 20 mcg     q.i.d.) in patients with chronic obstructive pulmonary disease (COPD).   "
185488|NCT00274053|"     The purpose of this study is to investigate the effect of a 9-month treatment of tiotropium     (SPIRIVA®) 18 mcg once daily on Health Related Quality of Life and lung function in patients     with a Chronic Obstructive Pulmonary Disease.   "
185489|NCT00274066|"     To evaluate acute effect of single dose of ipratropium (Atrovent) or fenoterol (Berotec) in     comparison to placebo when given to COPD patients on pharmacodynamic steady state of     tiotropium (Spiriva)   "
185490|NCT00274079|"     The objective of the study is to determine the effect on lung function when either SPIRIVA     once daily or placebo once daily is added to the usual therapy (care) of COPD patients naïve     to anticholinergic agents managed in primary care. Previous studies have been in both     hospital in and outpatients, with washout of some respiratory medications, this is the first     study to be conducted in General Practice, the drug's anticipated environment.      Data from this study, including the adverse event monitoring, and post study findings on     physical examination, will be used to extend the safety database. Health Resource Utilisation     (HRU) data will be recorded to be use with data from other sources for economic analysis of     COPD treatment.   "
185491|NCT00274092|"     The objective of this study is to compare the bronchodilator efficacy and safety of     tiotropium inhalation capsules (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg     q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)   "
185492|NCT00274105|"     The aim of this trial is to evaluate the efficacy and safety of telmisartan 80 mg     administered once daily in patients with documented coronary artery disease (CAD) and a     probably cardiovascular risk profile concerning the amelioration of structural alterations     and endothelial function.      The primary objective of this trial is to evaluate the efficacy in particular with regard to     the percentage change of atheroma volume in the femoral artery.The secondary objective is to     evaluate the change in the plaque size- assessed by intravascular ultrasound, the increase in     Flow Dependent Dilation provoked by intraarterial infusion of three increasing concentrations     of Acetylcholine, and the change in seated systolic blood pressure.      Endothelial dysfunction is a primary event in atherogenesis and all known cardiovascular risk     factors have been associated with endothelial dysfunction before atherosclerotic vascular     disease manifests itself clinically. Pivotal to endothelial dysfunction is a disturbance in     the function of endothelium-derived nitric oxide (NO). Recently, it could be shown that acute     and chronic angiotensin-1 receptor antagonism reversed endothelial dysfunction in     atherosclerosis. In experimental atherosclerosis, AT1 receptor blockade appears to have     protective effects. Respective potential mechanisms include the prevention of endothelial     injury, the augmentation of NO activity, the inhibition of lipid peroxidation and an     antiproliferative effect. These findings together with the most recent data that losartan     improves endothelial function and NO activity suggest that AT1 receptor antagonism may also     be antiatherogenic in patients with atherosclerosis. Angiotensin II influences smooth muscle     cell migration, hyperplasia, and hypertrophy. Angiotensin II also enhances production of     local superoxide anion, which will inactivate nitric oxide. Inhibition of these reactions by     the AT1-Blocker telmisartan may therefore interfere with atherosclerotic plaque formation.   "
185498|NCT00274183|"     Nonalcoholic fatty liver disease (NAFLD) is an emerging and important disease in Taiwan.     However, the prevalence and clinical characteristics have not been studied well. The purpose     of this study is to resolve the aforementioned problem.   "
185499|NCT00274196|"     The purpose of this study is to measure the sensitivity and specificity of ultrasound exam of     the hip in diagnosing occult hip fractures.   "
185500|NCT00274209|"     Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy     with dye spraying can detect subtle abnormalities that are not visible with standard     endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer targeted     biopsies can replace standard colonoscopy with multiple random biopsies.   "
185501|NCT00274222|"     This study was designed to evaluate the hypothesis that nebulized budesonide) might be an     alternative to systemic corticosteroids (SC) in the treatment of patients with acute     exacerbations of COPD (AECOPD).   "
185502|NCT00274235|"     Malaria in pregnancy is one of the most important preventable causes of low birthweight     worlwide and a major cause of severe maternal anaemia contributing to maternal mortality.     Intermittent Preventive Treatment (IPT) with sulfadoxine-pyrimethamine (SP) is the currently     adopted government recommendation for malaria control during pregnancy in Benin, but the     emergence and the spread of resistance to SP justifies the evaluation of alternative     anti-malarial drugs. Mefloquine (MQ), which has been proven effective and reasonably safe in     this indication, may be an interesting alternative to SP. The aim of this trial is to compare     the efficacy and safety of sulfadoxine-pyrimethamine and mefloquine for IPT. It is an     equivalent study designed to test the hypothesis that MQ is as efficacious as SP to prevent     malaria in pregnancy, and that it could replace SP when resistance of Plasmodium falciparum     becomes too elevated. Primary endpoint will be the proportion of infants with low     birthweight. Secondary endpoints will be the proportion of mothers with placental plasmodial     infection, and the proportion of mothers with anaemia at delivery.   "
185515|NCT00274404|"     The hypothesis is that an antiviral drug (valacyclovir) will reduce the amount of     Epstein-Barr virus (EBV) in the mouths of university students with infectious mononucleosis     (mono) while being a safe drug. Because EBV is the cause of mono, it is expected that     reduction of the amount of virus could result in faster recovery from the disease.   "
185516|NCT00274417|"     This study is for individuals electing to have GreenLight Photoselective Vaporization of the     Prostate (PVP) to treat symptoms from an enlarged prostate gland. The purpose of this     research study is to evaluate the safety and effectiveness of the medication dutasteride as     compared to placebo (an inactive substance) for improving surgical and long-term outcomes of     PVP. Dutasteride is approved by the United States Food and Drug Administration (FDA) for the     treatment of symptoms from an enlarged prostate gland. The use of dutasteride to improve the     outcomes of PVP is investigational. The study will last for approximately 15 months and will     involve 6 visits.   "
185503|NCT00274248|"     This is a phase 1, open-label, multicenter study investigating the use of MLN518 in     combination with standard chemotherapy to patients with newly diagnosed AML. Two dose levels     of MLN518—200 mg and 400 mg given orally twice a day are planned for sequential evaluation in     separate groups of patients. Patients assigned to the 400 mg dose level given orally twice a     day of MLN518, will potentially have their dose of MLN518 adjusted on the basis of MLN518     plasma concentrations measured during the first 3 days of induction therapy. All patients     will receive initial induction chemotherapy with cytarabine, 200 mg/m2/day by CIVI on Days 1     through 7, and with daunorubicin, 60 mg/m2/day by intravenous (IV) push (IV infusion if     borderline cardiac function is detected) on Days 1 through 3 (7+3). An abbreviated     cytarabine and daunorubicin regimen (5+2) will also be used when the initial remission     induction therapy fails to clear the bone marrow of blast cells (as typically detected on the     Day 15 bone marrow) and a second attempt at remission induction is indicated. Patients who     achieve a complete remission (CR) will receive consolidation therapy with HiDAC (standard or     modified) in combination with continued MLN518 treatment. Patients remaining in continuous CR     after completion of their last cycle of consolidation therapy will be permitted to continue     treatment with single-agent MLN518 for 6 months thereafter.   "
185504|NCT00274261|"     This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use     of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of     contraception over six months (183 days) and at least six cycles of use. In addition, there     is an opportunity for subjects to continue with study treatment for up to twelve months (365     days) and twelve cycles of treatment upon completion of the first six months of treatment.   "
185505|NCT00274274|"     This trial is conducted in Europe. This trial aims for a comparison of the efficacy and     safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy,     with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.   "
185506|NCT00274287|"     This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance     program in patients with androgen-independent prostate cancer (AIPC) who have achieved a     maximal response on a taxotere or other chemotherapy schedule.   "
185507|NCT00274300|"     The purpose of this study is to evaluate how well the vaccine is tolerated at sites where     administrations are given and any effects it may have on subjects' wellbeing. The study will     also test the ability of vaccine to cause particular immune responses in the body and     evaluate the effect it has on herpes outbreaks   "
185508|NCT00274313|"     The purpose of this study is to evaluate the safety and tolerability of a new inhaled     sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be     inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate     blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and     eliminated after 14 days of treatment.   "
185509|NCT00274326|"     Primary:        -  To assess the efficacy of SR121463B in correcting hyponatremia in patients with          dilutional hyponatremia other than SIADH or cirrhosis      Secondary:        -  To assess the long-term efficacy of SR121463B in maintaining normonatremia in these          patients        -  To assess the safety and tolerability of SR121463B   "
185510|NCT00274339|"     The purpose of this study is to evaluate changes in scores on the Reflux Finding Score and     Reflux Symptom Index over a 24 week period. To enroll subjects must score at least a 13 on     the Reflux Symptom Index and at least a 5 on the Reflux Finding Score. All subjects will     receive education on lifestyle modifications with a nutritionist and exercise trainer. All     subjects will be expected to comply with lifestyle modifications for the entire study period     of 24 weeks. Half of all subjects will receive Prevacid 30mg BID and half will receive     placebo BID for 24 weeks. Subjects will have 4 office visits over 24 weeks and weekly     contacts with the study staff to assess Reflux Symptom Index and any health or medication     changes.   "
185511|NCT00274352|"     The purpose of this study is to determine if adalimumab is an effective for the skin     manifestations of sarcoidosis.   "
185512|NCT00274365|"     Online consulatations through videoconference in the field of psychiatry given to general     practitioners will reduce costs of medical treatment and improve service.   "
186182|NCT00284076|"     To assess the effects of L-arginine upon functional status (treadmill exercise testing;     quality of life) and limb blood (by mercury strain gauge plethysmography) in peripheral     arterial disease.   "
185513|NCT00274378|"     Allomatrix is a combination of Demineralized Bone Matrix with a binding medium of calcium     sulfate hemihydrate and carboxymethylcellulose. Allomatrix combines the osteoinductive     capacity of DBM with the osteoconduction and controlled resorption of surgical grade calcium     sulfate.      Unstable fractures of the distal radius do not resist displacement once it has been     manipulated into an anatomical position.      There is a parallel between the quality of the anatomic result and the residual capacity of     the wrist, except in older, low demanding patients.      Injectable osteoconductive cements have been introduced to fill voids in metaphyseal bone and     may provide a better stability around hardware in osteoporotic bone and help maintain     reduction of fracture fragments.Moreover, a product like ALLOMATRIX could accelerate and     improve bone healing and fracture stability by its osteoinductive properties. However, the     clinical significance of these new bone graft materials still have to be proven in a     randomised controlled study set-up.   "
185514|NCT00274391|"     The purpose of this research study is to determine whether the combination of inhaled     amiloride and a concentrated salt solution is better than the salt solution itself for cystic     fibrosis (CF) patients. In CF, airway secretions are thick and dehydrated. Many patients use     inhaled salt solutions to help draw water into their secretions so that they are easier to     get rid of with chest physiotherapy (“chest PT”) and cough. Unfortunately, these salt     solutions are reabsorbed very quickly by the airways, so the beneficial effects may not last     very long. In the hopes of prolonging their effects, the drug amiloride could be used in     combination to slow salt and water reabsorption from airways. Amiloride is a medication that     has been given by mouth for high blood pressure for many years. It is possible that the     combination of salt solutions and inhaled amiloride may significantly improve the clearance     of secretions in CF, which would be expected to improve lung function in CF.   "
185517|NCT00274430|"     A double-blind placebo controlled study        -  To compare the effect of tadalafil and dexamethasone versus placebo on Ppa and pulmonary          edema formation in subjects susceptible to HAPE.        -  To investigate the effect of dexamethasone on alveolar fluid clearance, as assessed by          measurement of the nasal potential difference, and prevention of HAPE.        -  To investigate the effect of the tadalafil and dexamethasone versus placebo on the          dynamic CBF autoregulation properties and on the development of AMS in HAPE susceptible          subjects.   "
185518|NCT00274443|"     This is an open-label dose escalation trial using ABI-007 plus carboplatin.   "
185519|NCT00274456|"     This was an open-label study conducted comparing the toxicity and antitumor activity of     ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).   "
185520|NCT00274469|"     The purpose of this study is to compare the efficacy and tolerability of Faslodex     (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor     positive advanced breast cancer.   "
185521|NCT00274495|"     To study the effectiveness and safety of adding Rosiglitazone, an insulin sensitizing agent     to people with chronic hepatitis C infection genotype 1 with fatty liver disease, who are     being treated with standard therapy. Standard therapy consists of weekly pegylated interferon     injections and daily ribavirin pills, whose dosage is weight based. This regimen in genotype     1 patients is effective in only 45% of patients at best. In addition, this therapy must be     given for 48 weeks to be effective and has alot of side-effects. One risk factor for a poor     response is fatty liver. Rosiglitazone has been shown to be effective in the treatment of     patients with fatty liver alone. This study hopes to show that the addition of Rosiglitazone     to the standard therapy in genotype 1 patients with fatty liver disease will increase     effectiveness of the standard therapy of hepatitis C.   "
185522|NCT00274508|"     To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD   "
185523|NCT00274521|"     The study was designed to determine whether tiotropium inhalation capsules, compared to     placebo, enhances the improvement in exercise tolerance seen in patients with chronic     obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation. In     addition, assessments of the effect of tiotropium on dyspnea and quality of life following     pulmonary rehabilitation were taken.   "
185524|NCT00274534|"     To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to     Salmeterol MDI in patients with moderate to severe COPD.   "
185525|NCT00274547|"     The primary objective of this trial is to determine whether treatment with tiotropium (18     mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD     experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation     during a six month observation period.   "
185526|NCT00274560|"     The objective of the study was to evaluate the degree of improvement in lung function in     patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium     inhalation capsules compared to salmeterol inhalation aerosol .   "
185527|NCT00274573|"     The primary objective of this study is to investigate the effect of tiotropium vs. placebo on     trough FEV1 and FEV1 2 hours post inhalation after 12 weeks of treatment. For both endpoints     changes from baseline will be analysed. Three strata of patients will be included (severe     COPD, i.e. <35% of predicted FEV1, moderate COPD, i.e. 35% - <50% of predicted FEV1, mild     COPD, i.e. 50% - 70% of predicted FEV1, according to American Thoracic Society [ATS]     criteria). The study is conducted in order to find out for which endpoint tiotropium is     different from placebo in which stratum.   "
185528|NCT00274586|"     Tolerability of a four weeks treatment with Aggrenox® modified release capsules b.i.d,     compared to reduced dose during the first two weeks of treatment in a double-blind,     randomized controlled parallel group comparison trial among Taiwanese patients with previous     TIA's or ischemic stroke.To monitor frequency and intensity of headaches and other safety     parameters among Taiwanese patients with previous TIA's or ischemic stroke given Aggrenox     using a titration scheme or not   "
185529|NCT00274599|"     Demonstrate that telmisartan 80mg was at least as effective and possibly superior to ramipril     5mg & 10mg in lowering mean ambulatory DBP and SBP during the last 6 hrs of the 24-hr dosing     interval in mild-to-moderate hypertensives at the end of 8 and 14 week treatment phases.   "
185530|NCT00274612|"     The primary objective of this study is to demonstrate that telmisartan 80 mg (MICARDIS®) is     at least as effective and possibly superior to ramipril 5mg and 10mg in lowering mean     ambulatory diastolic blood pressure (DBP) and systolic blood pressure (SBP) during the last 6     hours of the 24-hour dosing interval in mild-to-moderate hypertensive patients at the end of     an 8 and 14-week treatment period, respectively.   "
185531|NCT00274625|"     The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture     closure alone in preventing an incisional hernia after open bariatric surgery.   "
185532|NCT00274638|"     To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior     to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate     hypertensives.   "
185533|NCT00274651|"     Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with     recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101     is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with     belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.   "
185546|NCT00274820|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of     cancer cells. The cancer is said to be resistant to chemotherapy. Giving ascorbic acid may     reduce drug resistance and allow the cancer cells to be killed. Thalidomide may stop the     growth of cancer cells by blocking blood flow to the cancer. Giving arsenic trioxide together     with ascorbic acid, dexamethasone, and thalidomide may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with     ascorbic acid, dexamethasone, and thalidomide works in treating patients with chronic     idiopathic myelofibrosis or myelodysplastic or myeloproliferative disorders.   "
185988|NCT00271453|"     The purpose of this study is to assess the effectiveness and safety of DurogesicÂ® (a     transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of     children with chronic pain requiring long-term narcotic pain relief therapy.   "
185534|NCT00274664|"     Amblyopia (‘lazy eye’) is the commonest visual disorder of childhood and is caused by an     interruption to visual development. Occlusion of the better eye by patching is the mainstay     of treatment, so forcing use, of the affected eye. We have little understanding of how much     treatment is required for improvement, so occlusion may continue for many months. This is     both demanding for the child and family as a whole. Treatment outcome is frequently     unsatisfactory. Compliance is often poor, thus we do not know precisely how much treatment     the child actually receives or how much is required.      To overcome this, we have designed an instrument that permits us to measure occlusion: an     occlusion dose monitor (ODM) which provides an objective record of how much occlusion a child     actually receives. Recently we have observed that 75% of improvement induced by occlusion     occurs in the first four weeks of treatment. In this study we explore the possibility that by     intensive treatment the period of amblyopia therapy can be shortened – i.e. treatment will be     more efficient, more effective, and more ‘family-friendly’. The study hypothesis is that 12     hours/day of patching is more effective than 6 hours/day.   "
185535|NCT00274677|"     This study is an 8-week evaluation of an investigational drug for treating depression in     bipolar patients. Depressed patients will be given either an investigational drug or placebo     and receive psychiatric assessments of their depression at weekly visits. Study drug and all     study-related visits are provided at no cost to the patient. The patient agrees to meet with     study research staff for roughly 11 clinic visits.   "
185536|NCT00274690|"     The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic     medication to prevent nausea and vomiting in females after surgery.   "
185537|NCT00274703|"     Eosinophils play a key role in the pathogenesis of eosinophilic oesophagitis. Therapies that     suppress eosinophil recruitment and activation may give a benefit. Mepolizumab is a humanised     monoclonal antibody against interleukin-5 (IL-5). This study will evaluate the ability of     mepolizumab to decrease the recruitment and infiltration of eosinophils into the oesophagus,     thereby reducing the inflammation and symptoms of EE (eosinophilic oesophagitis) in adult     patients.   "
185538|NCT00274716|"     The objective of this study is to evaluate the safety and efficacy of two investigational     drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with     hypertension (high blood pressure).      This is an early phase trial and some specific protocol information is proprietary and not     publicly available at this time. (Full information is available to trial participants).   "
185539|NCT00274729|"     The purpose of this study is to investigate the effect of three diets different in type and     amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.   "
185540|NCT00274742|"     The purpose of this study is to determine whether a continuous infusion of Blinatumomab     (MT103) is safe in the treatment of relapsed Non-Hodgkin's Lymphoma.      Furthermore, the study is intended to provide pharmacokinetic and pharmacodynamic data of     Blinatumomab as well as to get first indication of tumour activity.   "
185541|NCT00274755|"     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and magnetic     resonance spectroscopic imaging (MRSI), (done before, during, and after treatment) may help     doctors predict a patient's response to treatment and help plan the best treatment.      PURPOSE: This phase II trial is studying how well MRI and MRSI evaluate patients who are     undergoing treatment for gliomas.   "
185542|NCT00274768|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well capecitabine works in treating patients     with metastatic breast cancer.   "
185543|NCT00274781|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and gemtuzumab ozogamicin,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more cancer cells.      PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with     gemtuzumab ozogamicin works in treating patients with advanced myelodysplastic syndromes.   "
185603|NCT00266305|"     The main purpose of the study was to examine whether fish oil supplementation of lactating     mothers affect infant development during first year of life, focusing on visual and mental     development. A follow-up studies are conducted in order to see if early intake of long-chain     n-3 polyunsaturated fatty acids (n-3 LCPUFA) have any long-term effects on health, primarily     immun function and markers of cardiovascular risk.   "
185544|NCT00274794|"     RATIONALE: Drugs used in chemotherapy, such as busulfan, etoposide, and cyclophosphamide,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving colony-stimulating factors, such as G-CSF, monoclonal     antibodies, such as rituximab, or chemotherapy, such as etoposide, helps stem cells move from     the bone marrow to the blood so they can be collected and stored until transplant. Giving     etoposide and G-CSF together with rituximab before a peripheral stem cell transplant may be     an effective treatment for non-Hodgkin's lymphoma.      PURPOSE: This randomized clinical trial is studying how well giving etoposide and G-CSF with     or without rituximab works in treating patients who are undergoing an autologous peripheral     stem cell transplant for B-cell non-Hodgkin's lymphoma.   "
185545|NCT00274807|"     RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, cytarabine, and etoposide, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more cancer cells.      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating     patients with newly diagnosed acute myeloid leukemia.   "
185547|NCT00274833|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation     therapy together with temozolomide and erlotinib after surgery may kill any remaining tumor     cells.      PURPOSE: This phase II trial is studying how well giving radiation therapy together with     temozolomide and erlotinib works in treating patients with newly diagnosed glioblastoma     multiforme.   "
185548|NCT00274846|"     RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps     stop the growth of cancer cells. It also helps stop the patient's immune system from     rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) cells     from a donor are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets.      PURPOSE: This clinical trial is studying how well a peripheral stem cell transplant using NK     cells from a donor works in treating patients with relapsed acute myeloid leukemia.   "
185549|NCT00260130|"     The 2010 National Health Objectives call for a reduction in the prevalence of obesity. The     marked recent increase in overweight and obesity prevalence implicates behavioral factors in     the etiology of the epidemic. The present proposal hypothesizes the trend is attributal, in     part, to increasing consumption of energy-yeilding beverages since they are a significant and     increasing source of dietarty energy and they elicit weaker appetitive and dietary responses     than solid foods.   "
185550|NCT00265603|"     The purpose of this study is to determine the safety of using a treatment called     transimmunization in addition to standard therapy (radiation) in the treatment of lung     cancer. Transimmunization is a treatment of the blood designed to boost the immune response     against lung cancer. Transimmunization uses a device called a UVAR-XTS instrument, to remove     a portion of blood, part of which is returned, and part of which is incubated overnight     before being returned to the bloodstream the next day.   "
185551|NCT00265616|"     The purpose of this study is to determine whether propofol or barbiturates should be     preferred in the treatment of status epilepticus (continuous seizure activity) refractory to     2 standard antiepileptic agents.   "
185552|NCT00265629|"     This is an early feasibility trial designed to demonstrate whether a new ablation device can     be used safely and effectively in treating atrial fibrillation.      This study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at     a single study site   "
185553|NCT00265642|"     The purpose of this study is to examine the efficacy of irbesartan on the progression of     liver fibrosis in adult patients with chronic hepatitis C.      The expected total enrollment is 200 patients. Patients who meet the study criteria and     accept to participate at this study will take by day one tablet of 150 mg of treatment     (irbesartan or placebo) during two years. The assessment of efficacy will be make by     evaluation of area of liver fibrosis and blood markers of liver fibrosis   "
185554|NCT00265655|"     To determine the objective response rate (ORR) of oral satraplatin in patients with     Metastatic Breast Cancer.   "
185555|NCT00265681|"     The primary objective is to evaluate the effectiveness of telephone-based counseling in     promoting smokeless tobacco cessation among residents of Minnesota. It is hypothesized that a     greater proportion of individuals assigned to the proactive telephone calls will quit their     use of smokeless tobacco products and all tobacco products compared to the comparison group     not receiving those calls.   "
185556|NCT00265694|"     1. Recently a radomized trial of vinorelbine versus best supportive care in patients at 70          years of age or older demonstrated a definite improvement in overall survival rate and          quality of life with chemotherapy.        2. The role of combination therapy containing the platinum compound, which is the standard          therapy for the young patients is still vague.        3. Gemcitabine and carboplatin have favorable toxicity profile.   "
185557|NCT00265707|"     -  A disposable blood pressure measuring device will be tested and compared to a standard          mercury sphygmomanometer.        -  Up to 100 subjects with various levels of blood pressure values will be tested.   "
185635|NCT00266721|"     The hypothesis of this study is that the administration of pancrelipase with meals will     benefit symptoms of post-prandial bloating, pain and eructation.   "
185558|NCT00265720|"     Colorectal cancer is the second deadliest among cancers and disproportionately affects     African Americans. The Colorectal Cancer Screening Intervention Trial(CCSIT) project has as     its goal to test three interventions designed to increase screening rates among medically     underserved African Americans in the Metropolitan Atlanta area. It is designed to increase     awareness of modifiable risk factors and promote the benefits of screening as a means of     early detection of colorectal cancer. mportance of being screened for colorectal     cancer,African Americans continue to be disproportionately affected by this disease. The     Colorectal Cancer Screening   "
185559|NCT00265733|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex and capecitabine, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with     capecitabine works in treating patients with metastatic breast cancer.   "
185560|NCT00265746|"     Gestational diabetes is also a strong risk factor for the development of diabetes mellitus at     a later stage of life in previous GDM woman. Among all the risk factors of diabetes mellitus,     the experience of gestational diabetes is the strongest one. The incidence of various forms     of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years.      The aim of this study is a comparison of the efficacy of life style modification and life     style modification in conjunction with metformin administration, in a population of women,     who had already experienced gestational diabetes.   "
185561|NCT00265759|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of     estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make     the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not     yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast     cancer.      PURPOSE: This randomized phase III trial is studying exemestane, letrozole, and anastrozole     to compare how well they work in treating postmenopausal women who are undergoing surgery for     stage II or stage III breast cancer.   "
185562|NCT00265772|"     The primary purpose of this study is to compare the efficacy of enteral nutrition compared to     steroids in inducing remission of active pediatric Crohn’s disease. The main hypothesis of     this study is that the use of enteral nutrition induces mucosal healing, whereas steroids do     not. This effect may be related to a change of the commensal flora during enteral nutrition.   "
185563|NCT00265785|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating     patients with stage III or stage IV non-small cell lung cancer.   "
185564|NCT00265798|"     This phase II trial is studying how well sorafenib works in treating patients with malignant     gastrointestinal stromal tumor that progressed during or after previous treatment with     imatinib mesylate and sunitinib malate. Sorafenib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
185565|NCT00265811|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     combination chemotherapy with or without cetuximab after surgery may kill any remaining tumor     cells and keep colon cancer from coming back. It is not yet known whether giving combination     chemotherapy together with cetuximab is more effective than giving combination chemotherapy     alone in treating colon cancer.      PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab     to see how well they work compared to combination chemotherapy alone in treating patients     with stage III colon cancer that was completely removed by surgery.   "
185566|NCT00265824|"     PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab     alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work     compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy     combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer     that cannot be removed by surgery.   "
185567|NCT00265837|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow     transplant or peripheral blood stem cell transplant helps stop the growth of cancer and     abnormal cells and helps stop the patient's immune system from rejecting the donor's stem     cells. When certain stem cells from a donor are infused into the patient they may help the     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Sometimes the transplanted cells from a donor can make an immune response against the body's     normal cells. Removing the T cells from the donor cells before transplant may stop this from     happening.      PURPOSE: This randomized phase III trial is studying donor bone marrow that is treated in the     laboratory using two different devices to compare how well they work in treating patients who     are undergoing a donor bone marrow transplant for hematologic cancer.   "
185588|NCT00266110|"     RATIONALE: Vaccines made from a person's white blood cells may help the body build an     effective immune response to kill tumor cells. Monoclonal antibodies, such as trastuzumab,     can block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine     therapy together with trastuzumab and vinorelbine may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with     trastuzumab and vinorelbine works in treating patients with locally recurrent or metastatic     breast cancer.   "
185568|NCT00265850|"     PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given     together with combination chemotherapy to compare how well they work in treating patients     with metastatic colorectal cancer.      RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.     Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving monoclonal antibodies together with combination     chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy     is more effective with cetuximab and/or bevacizumab in treating patients with colorectal     cancer.   "
185569|NCT00265863|"     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above     normal body temperature. Peritoneal infusion of heated chemotherapy drugs, such as mitomycin,     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well mitomycin works when given as a     hyperthermic peritoneal perfusion in treating patients with malignant ascites.   "
185570|NCT00265876|"     RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving AZD0530 together with gemcitabine may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of AZD0530 when     given together with gemcitabine and to see how well they work in treating patients with     locally advanced or metastatic pancreatic cancer that cannot be removed by surgery.   "
185571|NCT00265889|"     RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an     effective treatment for Hodgkin's lymphoma.      PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants     works in treating patients with progressive or recurrent Hodgkin's lymphoma.   "
185572|NCT00265902|"     RATIONALE: Diagnostic procedures, such as infrared thermography, may help find Kaposi's     sarcoma and learn the extent of disease.      PURPOSE: This clinical trial is studying how well infrared thermography finds skin lesions in     patients with Kaposi's sarcoma.   "
185582|NCT00266032|"     The purpose of the study is to determine safety and efficacy of long-cycle regimens of an     oral contraceptive.   "
185573|NCT00265915|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such     as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood.     Giving rituximab together with GM-CSF may be an effective treatment for chronic lymphocytic     leukemia.      PURPOSE: This phase II trial is studying how well giving rituximab together with GM-CSF works     in treating patients with B-cell chronic lymphocytic leukemia.   "
185574|NCT00265928|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Giving bortezomib     together with rituximab may be an effective treatment for non-Hodgkin's lymphoma.      PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab     works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma,     including Waldenstrom's macroglobulinemia.   "
185575|NCT00265941|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Cisplatin may also make tumor     cells more sensitive to radiation therapy. Monoclonal antibodies, such as cetuximab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Giving radiation therapy and cisplatin together with cetuximab may kill more tumor cells. It     is not yet known whether radiation therapy and cisplatin are more effective with or without     cetuximab in treating head and neck cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy, cisplatin, and     cetuximab to see how well they work compared to radiation therapy and cisplatin in treating     patients with stage III or stage IV head and neck cancer.   "
185576|NCT00265954|"     High quality behavioral weight loss programs are not widely accessible. The Internet offers     one way to deliver health behavior programs to a wider audience. However, effective weight     loss treatments are intensive and program delivery over the Internet may not be capable of     duplicating the level of engagement typically generated during traditional in-person     treatment. The goal of this study is to test the effectiveness of three weight loss     interventions: Internet alone, Internet+periodic in-person support, and in-person alone. The     investigators hypothesize that the in-person and internet+in-person interventions will     produce better weight loss and maintenance than the internet only group.   "
185577|NCT00265967|"     Study objectives:        -  To demonstrate the effect of irbesartan on the regulation of diastolic blood pressure,          in case of missing one dose after a period of administration for 6 to 8 weeks        -  To evaluate the safety of irbesartan   "
185589|NCT00266123|"     To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL +     MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to     renal allograft function at month 12 post-transplantation.   "
185590|NCT00266136|"     The study in patients with primary and secondary AML and high-risk MDS uses a     risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of     G-CSF priming, and of autologous stem cell transplantation.   "
185591|NCT00266149|"     The present study evaluates the effect of oral contraceptives on lamotrigine plasma     concentrations in a double blind, placebo controlled, cross-over study in patients with     epilepsy.   "
185636|NCT00266734|"     To compare the efficacy of a recently FDA approved point of care diagnostic test, the RPS     Adeno Detector (Rapid Pathogen Screening, Inc.; South Williamsport, PA), against cell culture     for detecting adenoviral conjunctivitis   "
185578|NCT00265980|"     Previous work in our laboratory, and many others, has shown that body weight is regulated.     When anyone, fat or thin, tries to maintain a reduced body weight, many systems affecting     energy balance (skeletal muscle, neuroendocrine, and autonomic systems) conspire to slow     metabolic rate thus favoring the regain of lost weight. Individuals with leptin deficiency     are remarkably similar to weight-reduced individuals. Their metabolism, thyroid hormones, and     sympathetic nervous system activity are all low despite their obesity. While administration     of leptin to leptin-deficient humans results in substantial weight loss and increases in     energy expenditure. However, leptin administration to leptin-sufficient humans at usual body     weight has little or no effect on weight unless given in doses 10-20 times what would be     considered to be in the normal physiological range. This study examines the hypothesis that     leptin is read by various systems regulating energy balance as an indicator of how much     energy we have stored and that the body perceives the weight-reduced state as a condition of     relative leptin insufficiency. Within this model, restoration of leptin to levels present     prior to weight loss should relieve much of the metabolic opposition to keeping weight off.     Preliminary studies support this hypothesis.      Healthy lean and overweight subjects are admiited to the General Clinical Research Center at     Columbia University Medical College and placed on a liquid formula diet. Calories are     adjusted until weight is stable and then subjects undergo testing of neuroendocrine,     autonomic, and metabolic function. All subjects undergo an in-patient 10% weight reduction.     Subjects are studied in a single blind placebo control design in which they are studied at     usual weight and while maintaining a 10% reduced weight. At either usual weight or reduced     state subjects undergo a single blind crossover placebo/control study in which they receive     placebo,lepin injections while on an isocaloric diet either at usual weight or following a     10% weight loss. Leptin injections are given in doses that restored 8AM circulating leptin     concentrations to those present at initial body weight.   "
185579|NCT00265993|"     Study objectives :        -  To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute          venous thromboembolic disease.   "
185580|NCT00266006|"     This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and     preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute     intracerebral haemorrhage.   "
185581|NCT00266019|"     Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases. The     cause of NASH is not completely understood and currently there is no effective treatment for     this disease. An effective approach to treatment is needed since without treatment this     disease may progress to fibrosis and cirrhosis. Obesity is one of the most important risk     factors for NASH and weight reduction is generally recommended as an initial step in its     management. However, there are very limited data on the efficacy of weight reduction as a     treatment for NASH. Data from uncontrolled trials using poorly defined primary outcome     measures and patient populations and nonstandardized weight loss interventions suggest that     modest weight loss may improve fatty liver disease. The objective of this project is to     conduct a randomized controlled trial of weight reduction in the management of NASH using a     combination of diet, exercise, and behavior modification.   "
185583|NCT00266045|"     The results of the Prolong study, currently submitted for publication, show that patients     with a first unprovoked venous thromboembolic event who have altered D-dimer levels, measured     one month after anticoagulation with vitamin K antagonists is stopped, have a high rate of     recurrences (about 14%) and a prolongation of anticoagulation is effective in reducing     significantly this rate. Those patients with normal D-dimer (about 60% of all patients     examined) have a low rate of recurrences (about 5%) and likely a prolongation of     anticoagulation in all these patients cannot be recommended.      In line with these results, the Prolong-Two study aims at assessing the predictive role for     recurrence of D-dimer levels measured: a) during anticoagulation, b) one month after its     withdrawal and c) periodically during follow up.      Patients with a first unprovoked venous thromboembolism (including proximal deep vein     thrombosis of a leg and/or pulmonary embolism) which are treated with vitamin K antagonists     for not less than 6 months are considered for the study. D-dimer assay is performed during     anticoagulation and patients with altered results continue the anticoagulation for 6 more     months. Those with normal D-dimer stop the anticoagulant treatment and are again examined one     month later. Anticoagulation is resumed for 6 more months in those patients with abnormal     D-dimer results but is permanently stopped in those with a normal assay. The latter patients     are examined and D-dimer assay performed again every two months to evaluate the natural     history of the assay after anticoagulation is stopped and the possible predictive value for     recurrence of a change of the assay during follow-up from normal to abnormal results.   "
185584|NCT00266058|"     The purpose of this study is to find out whether taking certain anti-HIV medicines with     certain antimalarial medicines affects the amount of the medicines in the blood.      The study medicines that will be used are artemether/lumefantrine (antimalarial medication)     and lopinavir/ritonavir or efavirenz (anti-HIV medications). Artemether/lumefantrine is not     approved by the United States Food and Drug Administration (FDA) but is recommended as     standard of care medical treatment for malaria in Africa and Asia. Lopinavir/ritonavir and     efavirenz are approved by the FDA. Artemether/lumefantrine and lopinavir/ritonavir or     efavirenz may need to be used together to treat children in Africa and Asia. We seek to learn     about whether or not the use of these medicines together results in a change in blood levels     of any of these medicines. The information obtained from this study will help doctors to     provide a better treatment to children and adults with malaria and HIV.   "
185585|NCT00266071|"     Pressure ulcers are a common and frustrating problem and their treatment is critical in     elderly people. The interaction between external pressure and the skin vascular is central to     the prevention of pressure ulcers. It is only through understanding of the physiology of     cutaneous perfusion and its relation to external pressure or different stimuli that effective     preventive measures to reduce skin beakdown can be adapted in clinical practice.   "
185586|NCT00266084|"     This study tested the safety and performance of a new cell collector device and compared the     results to those obtained with the current existing device that are being used routinely   "
185587|NCT00266097|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and gemcitabine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     oxaliplatin together with gemcitabine, erlotinib, and radiation therapy may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin,     gemcitabine, and erlotinib when given together with radiation therapy in treating patients     with unresectable and/or metastatic pancreatic cancer or biliary tract cancer.   "
185592|NCT00266162|"     Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that     constitutes a great burden at the individual as well as the familial and social level. The     combination of critically increased pulmonary vascular resistance, progressive pressure load     of the right ventricle and disturbance of pulmonary gas exchange result in long-term     polymorbidity. The objective of this study is to look into the effects of medium-term     pulmonary pressure-lowering treatment with oral bosentan in patients with congenital heart     defects and clinically relevant pulmonary arterial hypertension (PAH), taking advantage of     extensive diagnostic procedures.   "
185593|NCT00266175|"     Postoperative stenoses of the pulmonary artery vascular system seldom occur alone; they are     frequently found in connection with congenital heart defects or malformation syndromes. The     resulting increase of afterload represents a serious pressure load for the right ventricle.     Depending on the number and severity of the stenoses, gradual functional right ventricular     failure is to be expected. Due to limited clinical experience, there has not yet been a     consensus concerning the indications for the different therapeutic strategies (balloon     dilatation, stent implantation, surgical dilatation techniques). Up to now, only few     investigators in few centres use stents as therapy. Therefore, systematic multicenter     investigations assessing larger groups of patients undergoing this procedure are not yet     available. The same applies to other novel dilatation techniques, such as the use of the     cutting balloon as therapy for rigid valve stenoses.      By comparing and analysing different invasive forms of treatment (balloon dilatation, stent     implantation and surgery), we expect to achieve an optimisation of therapy.      In the study, the outcomes of different strategies as practiced now in German cardiological     centers will be compared and the main factors influencing the results will be determined. On     the basis of a standardized investigation before and one year after the intervention, these     comparisons with respect to the reduction of stenosis and corresponding changes of right     ventricular functional and anatomical changes are carried out correcting for known     confounders. The assessment of the different included invasive and non-invasive diagnostical     procedures with respect to their ability to detect pathological findings and their changes as     result of the treatment is an important secondary target of the study.   "
185609|NCT00266383|"     The human homologue of mice natural-resistance-associated macrophage protein 1 (Nramp 1)     gene, NRAMP 1, has been reported to play a role in the susceptibility to tuberculosis in     humans. The aboriginal population in Taiwan has a 5-fold higher prevalence of tuberculosis     than the Han Chinese. Whether genetic factors such as NRAMP 1 polymorphisms play a role in     the prevalence of tuberculosis in Taiwanese aboriginals should be clarified.   "
195634|NCT00400374|"     This is a phase I study of second primary tumor prevention in early stage (stage I/II)     patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).   "
185594|NCT00266188|"     Tetralogy of Fallot is the most frequent complex congenital heart malformation. Over the past     five decades, surgical repair has been performed with respectable results. However, relevant     postoperative residues frequently remain. Pulmonary insufficiency, in particular, has been     identified as a factor limiting the right ventricular function and, accordingly, the quality     of life and life expectancy.      With increasing use of cardiac MRI for both measurement of ventricular function and imaging     of pulmonary arteries, residual defects have been discovered that were not detectable by     echocardiography. There is mounting evidence of right ventricular pressure and volume stress     in Fallot patients after surgical correction. At present, it is impossible to detect right     ventricular insufficiency at an early stage. Hence, it is to be assumed that right     ventricular insufficiency is underdiagnosed and therapeutic action frequently is initiated     beyond the point of no return of ventricular function.      The objective of this study is the systematic collection of cross-sectional and longitudinal     data from extensive standardised examinations, including MRI, echocardiography, pulmonary     function and ergometry tests, ECG and quality of life assessments, in a large number of     patients with surgically corrected tetralogy of Fallot, and the setup of a database. The data     obtained are supposed to provide information on the long-term outcome of surgical correction,     to help establish criteria for necessity and time of re-intervention or re-operation, and to     assess the effectiveness of re-interventions and re-operations.   "
185595|NCT00266201|"     Usually, heart failure refers to myocardial insufficiency of the left ventricle. However,     in patients with congenital heart defects, often predominantly the right ventricle is     affected.      Brain natriuretic peptide (BNP) has been shown to be a reliable biomarker for left     ventricular function and severity of left ventricular failure.      The objective of the present investigation is to evaluate brain natriuretic peptide (BNP)     with regard to its predictive value as a biomarker for right ventricular function, clinical     symptoms and/or the patients' quality of life.To this end, blood levels of neurohumoral     markers are measured and tested for statistical correlation with exercise tolerance and right     ventricular function, as assessed by imaging methods. A sample of healthy volunteers serves     as a control group.   "
185596|NCT00266214|"     The purpose of this study is to evaluate the analgesic efficacy and safety of the lidocaine     patch 5% compared to placebo in patients with moderate to severe pain associated with carpal     tunnel syndrome.   "
185597|NCT00266227|"     This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study     evaluating the efficacy of retreatment with rituximab in subjects with active rheumatoid     arthritis (RA) who are receiving Methotrexate (MTX).   "
185598|NCT00266240|"     This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK     Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The     anticipated time on study treatment is less than 3 months, and the target sample size is     100-500 individuals.   "
185599|NCT00266253|"     This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK     Activator (2) in combination with metformin, compared to that of placebo (metformin     monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their     stable dose of metformin and will be randomized to receive either GK Activator (2) or     placebo. The anticipated time on study treatment is less than 3 months, and the target sample     size is 100-500 individuals.   "
185600|NCT00266266|"     HPV DNA testing by a clinician has been shown to be highly sensitive in detecting cervical     disease. Can we prove that HPV self-testing will be sufficiently sensitive to detect disease     in high risk population who for various reasons would not have routine pap smear screening?   "
185601|NCT00266279|"     This phase II study will test the response rate of combined oxaliplatin and capecitabine     treatment when administered at a given dose and schedule, in patients with Head and Neck     cancer for which there is no curative treatment.   "
185602|NCT00266292|"     The purpose of this study is to investigate the effects of long-chain n-3 polyunsaturated     fatty acids (n-3 LCPUFA) on immune function and cardiovascular disease risk   "
186715|NCT00281515|"     The purpose of this study is to compare the effects of Paclitaxel/Carboplatin and Lonafarnib     to those of Paclitaxel/Carboplatin in primary treatment of patients with epithelial ovarian     cancer.   "
185604|NCT00266318|"     The main purpose of this study is to evaluate the safety and tolerability of combination     therapy of daily interferon alfacon-1 (Infergen, CIFN) at high dosage (24 mcg) with ribavirin     (based on body weight) for 48 weeks in HCV genotype 1 infected subjects, who are     non-responders to previous pegylated interferon alfa plus ribavirin therapy.      This is an open-label, multicenter study. All subjects will receive Infergen 24 mcg     administered by injection daily plus ribavirin 800-1400 mg (based on body weight)     administered by mouth daily for 48 weeks      * If any 5 of the first 10 subjects can not tolerate the 24 mcg daily dosage of Infergen by     week 4, as determined by the principal investigator, then the dosage of Infergen will be     changed to 15 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body     weight) administered by mouth daily for 48 weeks   "
185605|NCT00266331|"     This study is for the patient with breast cancer. To take part in this study, external beam     radiation therapy needs to be part of the treatment plan. Reduced glutathione, an ingredient     of RayGel™, has been helpful in decreasing some radiation therapy side effects to the skin.      Reduced glutathione plays a vital role in both making DNA and cell repair. This study will     measure if RayGel decreases skin reaction in breast cancer patients treated with external     beam radiation therapy.   "
185606|NCT00266344|"     A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.   "
185607|NCT00266357|"     A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.   "
185608|NCT00266370|"     1. To establish a pathology reference laboratory for the consultation on the diagnosis of          infectious diseases and lymphoma.        2. To study the specific pathogens on 100 cases of unexplained death due to infectious          diseases in the files of Taiwan CDC and the Forensic Institutes of Department of Law and          Justice.        3. To study the distribution of children lymphoid lesions in Vietnam and Taiwan and their          virus association.        4. To establish a tissue bank for infectious diseases and lymphoma.   "
186838|NCT00291122|"     To assess the quantitative real time PCR results results of oligonucleotide probes for a     number of gene transcription products that may be useful as predictors of indicators of     response to celecoxib.   "
185610|NCT00266396|"     Despite the widespread use of total hip and knee arthroplasty, there is a notable lack of     consensus regarding postoperative treatment, mostly because of the lack of well-designed     studies testing the efficacy and effectiveness of such practices. In particular, there are no     evidence-based recommendations on the amount of weight that the patient should be advised to     bear on the operated leg after the operation.   "
185611|NCT00266409|"     An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in     symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective     Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI)     to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at     least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder.     Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI     alone during the study. Most symptom evaluations will be done using an automated phone     interview system. There are 4 clinic visits.   "
185612|NCT00266422|"     Comparison of short and long term neurological outcome of VLBW infants with and without early     onset hypotension required intervention. The cohort includes all VLBW infants born in our     institution between January 1997 and December 2000.   "
185613|NCT00266435|"     The main objective of this study is to compare the sensitivity and specificity of a new     system for analyzing the electrocardiogram (ECG) to the sensitivity and specificity of a     conservative treadmill test in asymptomatic subjects, classified by Framingham score as     moderate to high risk. Subjects will perform a routine exercise test with the addition of     another set of electrodes to record high resolution ECG. All subjects will perform a stress     echocardiography. The result of the routine ECG analysis will be compared to the new system     and to the echocardiography results.   "
185614|NCT00266448|"     The purpose of this study is to determine whether whole body washing with chlorhexidine in     combination with mupirocine nasal ointment is effective in the eradication of     meticillin-resistant Staphylococcus aureus (MRSA).   "
185615|NCT00266461|"     Postoperative ileus (POI), a transient impairment of gastrointestinal (GI) motility, commonly     occurs in patients who have undergone abdominal surgery and contributes to postoperative     morbidity, including delayed enteral nutrition, increased patient discomfort, and prolonged     hospitalization. POI appears to be have many causes, with activation of inhibitory reflexes,     inflammatory responses, and the effects of anesthesia and analgesics all playing roles.     However, there is no approved pharmacological therapy for the treatment and prevention of     POI.      Daikenchuto (TU-100) is an herbal formulation consisting of Asian ginseng, Zanthoxylum fruit     (Sichuan pepper), ginger, and malt sugar, which was originally described in Jin kui yao lue,     the classical medical textbook written in ancient China in the third century by Zhang Zhong     Jing. Since it was introduced to Japan, Daikenchuto has been used in the treatment of     abdominal pain and a feeling of coldness in the abdomen.      TSUMURA Daikenchuto Extract Granules, Product Code TU-100, is a modern herbal product     manufactured in the dosage form of granules by Tsumura & Co. The current Tsumura product,     TU-100, was approved for manufacture as a prescription drug in 1986 by the Japanese Ministry     of Health and Welfare and has been sold commercially as a prescription Kampo (a generic term     for the system of traditional medicine that was developed in Japan after being introduced     from China in the fourth century) drug in Japan for many years. The drug product proposed for     use in the clinical studies is identical to the drug currently sold in Japan. In addition,     all three botanical components and maltose syrup powder are considered as food substances and     are currently part of the United States food supply.      The purpose of this study evaluate the tolerability, efficacy and safety of TU-100 for the     treatment of postoperative ileus (POI) in patients undergoing laparotomy for large bowel     resection   "
185616|NCT00266474|"     Aim of the study is to detect the prevalence of chronic rhinosinusitis and the colonisation     with Pseudomonas aerug. in the upper airways in patients with cystic fibrosis.   "
185617|NCT00266487|"     The purpose of this study is to examine whether the lowering of blood homocysteine levels by     treatment with B vitamins can prevent cardiovascular disease   "
185618|NCT00266500|"     This study will investigate how different parts of the body lose body heat and will measure     the heat released by specific areas such as the limbs and abdomen. Animal studies suggest     that dissipation of body heat may affect energy expenditure, and therefore, body weight. This     study will explore the relationship between obesity and heat in humans.      Healthy people 18 years of age and older who are of normal weight or who are obese and who     are not taking medications for obesity-related medical conditions may be eligible for this     study. Candidates must have a body mass index (BMI) between 18 and 25 kg/m2 for normal weight     subjects or a BMI greater than 30 kg/m2 for obese subjects. All candidates must weigh less     than 300 pounds. Women must have a normal menstrual cycle or be postmenopausal.      Participants undergo the following procedures in a single day on an outpatient basis:        -  Medical history, physical examination, blood and urine tests and electrocardiogram.        -  DEXA and MRI scans of the trunk and limbs to measure the amounts of muscle, bone and fat          in the body. For the DEXA scan, the subject lies on a table while a very small dose of          x-rays is passed through the body. For the MRI, the subject lies on a table that is          moved into a steel cylinder. A magnetic field and radio waves produce images that are          used to measure fat in the trunk of the body, thighs, and arms.        -  Infrared photography of hands, front of thigh, and abdomen. A special camera is used to          measure the heat leaving the body.        -  Bicycle exercise test. The subject exercises on a stationary bicycle while the heart          rate, heart rhythm, blood pressure and oxygen consumption are measured. The pedal          resistance is increased gradually until the subject can no longer exercise and then the          resistance is gradually decreased for cool-down.      Participants who qualify for the second part of the study undergo the following procedures     during a 5-day in-hospital stay:        -  Temperature measurements. Body temperature is measured in the ear canal. Skin          temperature is measured with small round adhesive temperature-sensing patches placed on          the abdomen and limbs for up to 5 days.        -  Measurement of body radiowaves. A remote sensing device is used to measure microwaves          that are naturally released from the body.        -  Infrared photography of hands, front of thigh and abdomen is done several times during          the study.        -  Application of mild coolness to hands, thigh and abdomen. The subject's hand is exposed          to mild coolness first by immersion in cool water, then by a cool-water spray, then by a          cooled pad placed on the hand, and finally, with a device applied to the hand that cools          and has a gentle vacuum. The abdomen and thigh are similarly exposed. During each test,          an infrared camera records how heat is released by the body.        -  Temperature effects of a meal. The subject drinks lemon-flavored sugar water to          measure the body's response.        -  Bicycle exercise test. The subject exercises on three different occasions. During or          after some of the tests, mild cooling is applied to the abdomen, front of the thigh, or          hands.        -  Measurement of exhaled air (indirect calorimetry). The subject wears a hood that          collects and analyzes exhaled air for 15- to 30-minute periods.        -  Photography and videotaping. The subject is photographed and videotaped. The images do          not include views of any private parts, and the subject's identity is protected.   "
185695|NCT00276042|"     The study will be conducted in infants and children with acute otitis media, 6 months to less     than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to     describe bacteriologic efficacy in those with initial culture positive specimens with     different dosages of faropenem   "
185619|NCT00266513|"     This study investigates gene abnormalities in Primary Immune Deficiency(PID) with a goal of     improving the diagnosis and treatment of patients.      The specific disorders include:        1. X linked hyper IgM Syndrome which is caused by an abnormality in the CD40L gene.        2. NEMO associated immune deficiency which is caused by an abnormality in a gene called          NEMO.        3. Common variable immunodeficiency (CVID) which has an unknown genetic basis.        4. Other disorders of immunoglobulin production.      This study will:        1. Better characterize the clinical features of CD40 L deficiency and NEMO associated          immune deficiency and other related primary immune deficiency syndromes.        2. Determine the frequency of CD40 L and Nemo abnormalities.        3. Determine whether particular abnormalities in these genes are associated with more of          less severe illness or with specific symptoms.        4. Explore the basic mechanism by which these altered genes cause immune dysfunction.        5. Identify other genes causing low immune globulin levels and related primary immune          deficient states.   "
185620|NCT00266526|"     Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV   "
185621|NCT00266539|"     The purpose of this study is to compare two pain medications delivered by two different forms     of patient-controlled pain management systems: the Fentanyl HCl Patient-Controlled     Transdermal System (E-TRANS fentanyl) and the morphine intravenous pump. Fentanyl HCl and     morphine are narcotic pain relievers. The E-TRANS fentanyl system is a small unit worn on the     patient's upper outer arm or chest that uses low-intensity electrical current to deliver     fentanyl through the skin and into the patient's bloodstream. The patients studied will be     those who have just had scheduled abdominal or pelvic surgery.   "
185622|NCT00266552|"     The purpose of the study is to assess the effectiveness and safety of an oral solution of     risperidone (an antipsychotic medication) versus placebo in the treatment of conduct disorder     in children with mild, moderate, or borderline mental retardation.   "
185623|NCT00266565|"     Toxicity of anti-IL-5   "
185624|NCT00266578|"     The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the     treatment of eosinophilic esophagitis (EE).   "
185625|NCT00266591|"     The purpose of this study is to evaluate the effectiveness and safety of topiramate (an     antiepileptic medication) in patients with epilepsy.   "
185627|NCT00266617|"     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa in the     treatment of persistent anemia caused by advanced cancer and aggressive     adriamycin-chemotherapy. Epoetin alfa is a genetically engineered protein that stimulates red     blood cell production.   "
185628|NCT00266630|"     The efficacy and safety of the extended treatment to patients with most recent episode manic     or mixed who completed previous double blind study (F1D-JE-BMAC [Study BMAC]) will be     examined.   "
185629|NCT00266643|"     This study is to compare the tolerability of different methods for switching from another     medication to duloxetine for the management of diabetic nerve pain. The primary objective is     to compare the most gradual method with the most abrupt method, to see if they have different     tolerability.   "
185630|NCT00266656|"     This is an extension study that will gather long-term data on the effect of early growth     hormone (GH) treatment on adult height and other aspects of health and development in girls     with Turner syndrome. The main purpose is to determine whether girls who received 2 years of     GH treatment before 6 years of age achieve taller adult height than girls who were untreated     during this time. The study will also look at middle ear and hearing function, and cognitive     and behavioral development. Protocol completion is defined as attainment of height velocity     less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.   "
185631|NCT00266669|"     The purpose of this study is to investigate the efficacy and safety of a topical gel     formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate     to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to     autoimmune diseases, such as scleroderma.   "
185632|NCT00266682|"     People who have a slow heart beat, or whose heart does not beat on its own, may be in need of     an electronic device called a pacemaker. A pacemaker is implanted surgically just under the     skin in the upper chest area. This device helps the heart beat at a regular rhythm by sending     electrical signals (pacing) directly to the heart tissue through flexible wires called leads.     The purpose of this study is to demonstrate that the SelectSecure (Model 3830) lead is safe     and effective for both sensing the heart’s natural rhythm and pacing the heart when it does     not beat on its own. This lead will be studied in both the right atrium and right ventricle.     A previously market approved Medtronic lead model will serve as a comparison to prove the     safety and effectiveness of the SelectSecure Model.   "
185633|NCT00266695|"     To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study     (NCT00604383), and who are felt by the investigator to have the potential to benefit from the     ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion     of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additional data will be gathered to determine     the long-term safety and effect of ruboxistaurin on vision.   "
185634|NCT00266708|"     Patients with kidney failure have underlying bone disease at the time of transplant.     Fractures of various bones can be as high as 22%. Medication required for the transplant     plays a role in bone loss.      Bisphosphonates are used in the general population to treat bone loss of osteoporosis and     steroid-induced bone loss. While previous studies, using various bisphosphonates, have shown     preservation of bone mineral density in renal transplant recipients, we have demonstrated     that pamidronate, a second generation bisphosphonate, is associated with low bone turnover     while still preserving bone mineral density. Improved bone mineral density is associated with     decreased fracture risk in the general population, while low bone turnover may be associated     with increased fracture in dialysis patients.      The purpose of this study is to determine whether risedronate, a third generation     bisphosphonate, is effective in preserving bone density when given prophylactically following     renal transplantation and whether it is associated with low bone turnover at one year     following renal transplantation.   "
185637|NCT00266747|"     The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with     Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 700 mg     dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD).The     secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of     life in patients with GAD and to evaluate safety of SR58611A.   "
185638|NCT00266760|"     Episodic ataxia (EA) is a rare genetic disease characterized by episodes of imbalance,     incoordination, and slurring of speech. The underlying cause of EA is only partly understood,     and currently there are no established treatments. There is also little information about the     link between EA's clinical features and its genetic basis. The purpose of this study is to     better characterize EA and disease progression. In turn, this may direct the development of     future treatments.   "
185639|NCT00266773|"     The purpose of this study is to determine whether a telephone-based self-monitoring and     skills review program with personalized therapist feedback following group CST for chronic     pain can reduce and prevent relapse of the pain, physical disability, and psychological     distress experienced by patients with chronic pain of the muscles and bone.   "
185640|NCT00266786|"     Ketorolac has been marketed for several years in other forms (tablet and injectable) for the     short-term relief of pain. This study will test whether a new dosage form (nasal spray)     containing ketorolac is effective at relieving the pain of major abdominal surgery, and will     also assess product safety. Previous studies with the nasal spray have suggested that it is     similar to the previously approved injectable form in effectiveness for pain relief and in     its safety profile.      Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when     the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first     dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to     4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug,     subjects will be given morphine sulfate or other standard analgesics. Follow-up safety     evaluations will occur about 1 and 2 weeks after the start of dosing.      Subjects will be asked to answer questions about their pain relief and any possible side     effects of the drug during the study, and will be given physical examinations, including     nasal evaluations, before and during the clinical trial. A small amount of blood will be     drawn for routine clinical laboratory testing.   "
185702|NCT00276133|"     Small dense low-density lipoprotein (LDL) plays an important role in causing glomerular     injury through conversion to an oxidatively modified form of LDL. However, few studies     evaluated the effects of antilipidemic agents on the LDL particle size and renoprotective     actions in hyperlipidemic patients with non-diabetic nephropathy.   "
185641|NCT00266799|"     This is an open-label, multinational, randomized, multicenter trial designed to compare     pegylated liposomal doxorubicin with capecitabine as first line chemotherapy of metastatic     breast cancer. The primary objective of the study is to compare the time to disease     progression, although overall response rates, overall survival, quality of life, time to     treatment failure, and safety and tolerability will also be assessed.   "
185642|NCT00266812|"     This is a phase II, randomized, multicenter, open-label study designed to assess the safety     and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain     radiation and later on at 14 days on/14 days off schedule in patients with cerebral     metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be     evaluated by clinical follow up and Magnetic Resonance Imaging (MRI) performed every 2     months. Progression-free survival at 6 months, duration of overall survival, and quality of     life will also be evaluated.   "
185643|NCT00266825|"     The purpose of the study is to determine if increasing DHA intake during pregnancy can     increase gestation duration and enhance infant and childhood outcomes related to visual     acuity, stereoacuity, attention, and distractibility.   "
185644|NCT00266838|"     The antineoplastic agent Docetaxel (Taxotere®) is approved for the treatment of patients with     metastatic and locally advanced breast cancer and other malignancies. There are 2 frequently     used schedules of treatment with Docetaxel. Docetaxel can be administered every 3 weeks or in     a weekly regimen. The efficacy seems to be similar but the toxicity profile changes. In the     standard 3-weekly Docetaxel regimen the dose-limiting side effect is myelosuppression, while     in the weekly regimen there is only a mild myelosuppression. On the other hand, weekly     Docetaxel has a side effect that is rare in the 3-weekly schedule: epiphora (= tearing eye)     caused by dacryostenosis.      The underlying mechanism of dacryostenosis induced by weekly Docetaxel is fibrosis of the     lacrimal puncta and canaliculi. Docetaxel has been reported to be secreted in the lacrimal     tears. Direct contact between Docetaxel containing tears and the epithelial lining causes     chronic inflammation of the mucosa and ultimately fibrosis of the most narrow part of the     lacrimal outflow system i.e. the lacrimal puncta and canaliculi.      A surgical treatment is possible for dacryostenosis. In case of subtotal stenosis of the     lacrimal canaliculi, silicone intubation of the canaliculi is performed in order to prevent     further closure. In the case of complete stenosis, placement of a permanent pyrex glass tube     of Jones is required.      To our knowledge, there is no primary prevention for Docetaxel induced dacryostenosis.      The rationale of this randomized double blind interventional study is to investigate the     efficacy of corticosteroid versus artificial tears topical eye treatment in patients on a     weekly Docetaxel regimen in prevention of dacryostenosis. The dacryotoxic agent Docetaxel in     the lacrimal tears will be washed away by the repetitive use of eye drops. In addition, eye     drops containing corticosteroids have an anti-inflammatory effect and may further prevent the     formation of fibrosis.      A new treatment protocol will be investigated. Two different commercially available eye drops     will be compared: dexamethasone sodium phosphate (Maxidex®, Alcon) in one eye of the patient     and artificial tears (Lacrystat®, Viatris) in the other eye of the same patient. The study     period will start with topical eye treatment from day 1 of cycle 1 and will continue during     the administration of chemotherapy, with a final analysis at 26 weeks.   "
185645|NCT00266851|"     The purpose of this study is to assess the effectiveness of the azalide macrolide     azithromycin in adults with persistent asthma.      Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a     statistically significant and clinically meaningful improvement in overall asthma symptoms     and other patient-oriented asthma outcomes one year after initiation of treatment of adult     primary care patients with asthma?      Experimental Design: The investigators propose a one-year randomized, placebo-controlled,     blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of     azithromycin/placebo as adjunctive therapy (in addition to usual care) in 100 adult asthma     patients recruited from practice-based research networks (e.g., Wisconsin Research and     Education Network (WREN) and others). This practical clinical trial will (1) enroll a     representative sample of asthma patients encountered in the practices of primary care     physicians, (2) employ standard clinical trial methodology to ensure internally valid results     and (3) measure outcomes important to patients, so that the results will be valid and     applicable to the kinds of asthma patients encountered by family physicians and other primary     care providers.      Active study sites - Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee,     Madison, Mauston, Rice Lake, Tomah, Wausau; Colorado: Monument; Illinois: Peoria; Nevada:     Reno; North Carolina: Granite Falls; North Dakota: Minot; Ohio: Cleveland, Berea; Oklahoma:     Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford; Rhode Island:     East Providence   "
190993|NCT00339079|"     This study will compare the effectiveness of cognitive behavioral therapy, antidepressant     medication, and a combination of the two for treating hypochondriasis.   "
185646|NCT00266864|"     It has long been recognized that co-morbidity associated with multiple metabolic syndrome,     such as adverse body composition, insulin resistance and autonomic nervous system impairment,     may lead to significant increase in cardiovascular morbidity and mortality. It is unclear     whether the co-morbidity evident in this population are due directly to their immobility or     are the result of unfavorable changes in their underlying hormonal milieu. The purpose of     this study is to determine the effect of testosterone replacement therapy in hypogonadal     males on:      body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy     expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment   "
185647|NCT00266877|"     The purpose of this study is to learn whether HKI-272 is safe and effective in treating     non-small cell lung cancer.   "
185648|NCT00266903|"     Review the outcome of treatment with endothelin receptor antagonists (bosentan or sitaxsetan)     alone or in combination with Sildenafil (a PDE-5 inhibitor) in adult patients with pulmonary     hypertension due to congenital heart disease.   "
185649|NCT00266916|"     The primary objective of this study is to determine the clinical benefits of percutaneous     intervention to improve pulmonary blood flow on oxygen saturations, symptoms, exercise     tolerance and hematocrit in patients with complex cyanotic congenital heart disease who are     not candidates for surgical repair.   "
185650|NCT00266929|"     The purpose of this study is to compare the safety and effectiveness of surgical versus     conservative management of type II odontoid fractures among patients > 64 years of age. Of     secondary interest is to determine if there are differences in outcomes between anterior     screw fixation and posterior fusion of these fractures.   "
185651|NCT00266942|"     Our aim is a retrospective chart review seeking to determine any differences in the main     clinical and outcome variables as well as general outcome data such as functional recovery,     readmission rates, somatic growth and mortality. An n size of 150 to 200 for each of the 2     groups will give us excellent power to detect potential differences.   "
185652|NCT00266955|"     There is some evidence suggesting ADHD medication interaction could result in mild myocardial     ischemia/infarct.   "
185703|NCT00276146|"     The purpose of this study is to determine the benefits as well as side effects of giving     drugs called dipyridamole and magnesium to patients with sickle cell anemia (SCA).   "
185653|NCT00266968|"     Congenital heart disease affects 1 in 100 newborn babies each year and more than 2,000,000     Americans have a congenital heart defect. One common defect treated at Children's Healthcare     of Atlanta at Egleston is single ventricle heart. Due to these overwhelming numbers, the use     of diagnostic imaging technology to assess these defects and heart function is an important     step in the evolving care of this patient group.   "
185654|NCT00266981|"     The purpose of this study is to compare two techniques for treating patients with Whiplash     Associated Disorders, in relation to: disability, balance, cervical pain and cervical range     of motion.      The hypothesis: The APOS kit treatment is more effective than the short wave therapy.   "
185655|NCT00266994|"     The TE Registry is a multi-institutional bioinformatics database for the collection of data     relevant to TE. Participating HTRS affiliated study centers may enroll patients and enter     data in the TE Registry by completing enrollment and data entry forms and transmitting them     to the study center. The purpose of this study is to improve our understanding of the     epidemiology, pathophysiology, and outcome of patients suffering from thromboembolism (TE)     events.      The initial objectives of the registry are:        -  Evaluate the epidemiology and clinical characteristics of known prothrombotic risk          factors in persons with TE.        -  Identify the frequency and nature of complications associated with TE and its treatment.        -  Describe the phenotypes and complications seen in persons with multiple molecular risk          factors for TE.        -  Compare the epidemiology, clinical characteristics, and complications seen in patients          with and without known risk factors for TE.   "
185656|NCT00267007|"     The purpose of this study is to evaluate the neuroprotective effect of PROCRIT (epoetin alfa,     a glycoprotein that stimulates red blood cell production) versus placebo in patients with     cancer who develop chemotherapy-induced peripheral neuropathy due to combination Taxane and     Platinum-Based treatment.   "
185657|NCT00267020|"     The purpose of this research study is to determine the effects and toxicity of gemcitabine     alone or gemcitabine plus enzastaurin in patients with pancreatic cancer.   "
185658|NCT00274859|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with     oxaliplatin works in treating patients with metastatic cancer who cannot receive     anthracycline or taxane therapy.   "
185659|NCT00274872|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. It is not yet known which combination chemotherapy regimen is more     effective in treating colorectal cancer.      PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens     to compare how well they work in treating patients with metastatic colorectal cancer that     cannot be removed by surgery.   "
185660|NCT00274885|"     RATIONALE: Learning about the relationship between platinum levels in the blood and     neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients     live more comfortably.      PURPOSE: This phase IV trial is studying the relationship between platinum levels in the     blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal     cancer.   "
185661|NCT00274898|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Giving celecoxib after     radiation therapy and chemotherapy may kill any tumor cells that remain after radiation     therapy and chemotherapy. Sometimes, after radiation therapy and chemotherapy, the tumor may     not need additional treatment until it progresses. In this case, observation may be     sufficient.      PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works     compared to observation in treating patients who have undergone radiation therapy and     chemotherapy for stage II or stage III non-small cell lung cancer.   "
185662|NCT00274911|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as lomustine, cisplatin, and vincristine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving radiation therapy followed by combination chemotherapy after surgery may kill any     remaining tumor cells.      PURPOSE: This phase II trial is studying how well giving radiation therapy followed by     combination chemotherapy works in treating young patients with supratentorial primitive     neuroectodermal tumors.   "
185663|NCT00274924|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving rituximab together with combination chemotherapy may kill more     cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with combination     chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large     B-cell non-Hodgkin's lymphoma.   "
185664|NCT00274937|"     This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy     work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy     uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal     cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as     cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving radiation therapy together     with amifostine and chemotherapy may kill more tumor cells.   "
185701|NCT00276120|"     The purpose of this study is to identify novel genetic factors which distinguish breast     cancer in younger women compared to older women. By identifying these novel genetic factors     we believe more specific therapies can be developed and breast cancer may be prevented among     women with an increased cancer risk. A woman does not have to live in St. Louis to     participate.   "
185665|NCT00274950|"     RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it     progresses. In this case, observation may be sufficient. Drugs used in chemotherapy work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells.      PURPOSE: This phase III trial is studying how well observation and/or combination     chemotherapy works after surgery or biopsy in treating young patients with extracranial germ     cell tumors.   "
185666|NCT00274963|"     RATIONALE: Drugs used in chemotherapy, such as bendamustine and mitoxantrone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer     cells.      PURPOSE: This phase II trial is studying how well giving bendamustine together with     mitoxantrone works in treating patients with relapsed or refractory B-cell chronic     lymphocytic leukemia.   "
185667|NCT00274976|"     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them.      PURPOSE: This phase II trial is studying how well giving alemtuzumab by injection works in     treating patients with advanced chronic lymphocytic leukemia that did not respond to previous     fludarabine.   "
185668|NCT00274989|"     CLL2M is a phase 2, multicenter, open label study to investigate the possible therapeutic     benefits of using bendamustine in combination with rituximab for the treatment of patients     with previously untreated or relapsed CLL.   "
185669|NCT00275002|"     This phase II trial is studying how well giving O6-benzylguanine together with temozolomide     works in treating young patients with recurrent or progressive gliomas or brain stem tumors.     Drugs used in chemotherapy, such as O6-benzylguanine and temozolomide , work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. O6-benzylguanine may help temozolomide work better by making tumor cells more     sensitive to the drug. Giving more than one drug (combination chemotherapy) may kill more     tumor cells.   "
185670|NCT00275015|"     RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of     cancer cells by stopping them from dividing or killing them. Giving colony-stimulating     factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone     marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is     then given to prepare the bone marrow for the stem cell transplant. The stem cells are then     returned to the patient to replace the blood-forming cells that were destroyed by the     chemotherapy and radiation therapy.      PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with     total-body irradiation works in treating patients who are undergoing an peripheral stem cell     transplant for chronic lymphocytic leukemia.   "
185671|NCT00275028|"     This phase II trial is studying how well AZD2171 works in treating patients with recurrent     ovarian, peritoneal, or fallopian tube cancer. AZD2171 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor   "
185672|NCT00275041|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Giving irinotecan together with cetuximab may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving irinotecan together with cetuximab     works in treating patients with metastatic breast cancer.   "
185673|NCT00275054|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,     such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Sometimes the cancer     may not need treatment until it progresses. In this case, observation may be sufficient. It     is not yet known whether giving rituximab together with fludarabine and cyclophosphamide is     more effective than observation alone in treating chronic lymphocytic leukemia.      PURPOSE: This randomized phase III trial is studying rituximab, fludarabine, and     cyclophosphamide to see how well they work compared to observation alone in treating patients     with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.   "
185674|NCT00275067|"     RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     arsenic trioxide and temozolomide together with radiation therapy after surgery may kill any     remaining tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide     and temozolomide when given together with radiation therapy and to see how well they work in     treating patients with malignant glioma that has been removed by surgery.   "
185675|NCT00275080|"     This phase I trial is studying the side effects and best dose of vorinostat when given     together with decitabine in treating patients with advanced solid tumors or relapsed or     refractory non-Hodgkin's lymphoma, acute myeloid leukemia, acute lymphocytic leukemia, or     chronic myelogenous leukemia.      Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Giving vorinostat together with decitabine may kill more cancer cells.   "
185676|NCT00275093|"     This phase I trial is studying the side effects and best dose of temsirolimus in treating     patients with metastatic solid tumor or lymphoma that cannot be removed by surgery who have     different levels of liver function. Temsirolimus may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Temsirolimus may have different effects     in patients who have changes in their liver function   "
185704|NCT00276159|"     The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat     certain hematologic malignancies not responding to standard treatment.   "
185677|NCT00275106|"     RATIONALE: Drugs used in chemotherapy, such as prednisolone and dexamethasone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer     cells. It is not yet known whether prednisolone is more effective than dexamethasone when     given together with combination chemotherapy in treating lymphoblastic lymphoma.      PURPOSE: This phase III randomized clinical trial is studying prednisolone to see how well it     works compared to dexamethasone when given together with combination chemotherapy in treating     young patients with newly diagnosed lymphoblastic lymphoma.   "
185678|NCT00275119|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with     oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating     patients with locally advanced pancreatic cancer that cannot be removed by surgery.   "
185679|NCT00275132|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It is not yet known whether erlotinib is more effective than a     placebo in treating non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works     compared to a placebo in treating patients with stage III or stage IV non-small cell lung     cancer.   "
185680|NCT00275145|"     This study will investigate the separate and combined effects of aerobic and resistance     training on cardiovascular risk factors in overweight men and women with mild to moderate     dyslipidemia.   "
185681|NCT00275158|"     Pre-eclampsia complicates 7 - 10% of pregnancies and constitutes a leading cause of fetal     growth retardation and premature birth, as well as infant and maternal morbidity and     mortality. The kidney is the primary site of injury resulting in high blood pressure, loss of     protein into the urine and decreased kidney function. The release of vasoconstrictors over     vasodilators from an abnormal placenta may underlie pre-eclampsia. Nitric Oxide (NO) is an     important vasodilator that is thought to play an important role in the kidneys ability to     accommodate to a healthy pregnancy. Normal pregnancy in the rat is accompanied by increased     production of NO and its second messenger cGMP. There is a parallel increase in renal     expression of constitutive nitric oxide synthase (NOS), the enzyme that generates NO from     arginine. In the pregnant rat, an infusion of NG-nitro-L-arginine methyl ester (L-NAME), an     exogenous inhibitor of NOS, has been shown to replicate some of the hemodynamic features of     the syndrome of pre-eclampsia. In a recent animal study, L-arginine supplementation reversed     the adverse effects of L-NAME on pregnancy by attenuating the high blood pressure and by     significantly decreasing protein loss in the urine. To date, studies of the use of L-arginine     supplementation to treat women with pre-eclampsia have been small or uncontrolled and have     only assessed blood pressure as a primary outcome measure. We report a single center,     randomized, placebo-controlled trial of L-arginine supplementation for the treatment of     pre-eclampsia, in which precise physiological techniques have been utilized to assess kidney     dysfunction in addition to blood pressure.   "
185682|NCT00275171|"     The study aims at clarifying (in a randomized, double-blinded design):        1. Whether stimulation with 0.1 mg rhTSH 24, 48 or 72 hours before induction of a          131I-tracer dosis increases the 131I uptake in patients with atoxic multinodular goitre          and to study which time interval is the most optimal (Part I)        2. Whether patients suffering from atoxic multinodular goitre obtains a corresponding          goitre reduction compared with a control group when stimulating with 0.1 mg rh TSH 24,          48 or 72 hours before 131I therapy and when reducing the thyroid radiation dose to 50 Gy          (Part II)      The two studies will be carried out successively on the same patient population. The 131I     uptake will be carried out first followed by the I therapy itself. The patients are compared     with a placebo-treated control group going through the same course of treatment, but the 131I     dosis will be 100 Gy (standard treatment). After the 131I therapy, all patients are followed     during one year with a regular ultrasound scan of the thyroid gland and control of the     metabolic status. The patient satisfaction is monitored by the use of a     visual-analogue-scale.   "
185683|NCT00275184|"     The aim of this study is to determine whether taking bowel preparation (citramag and senna)     or a medicine to speed up transit through the stomach (metoclopramide), will improve the     quality of the images seen, increase the transit through the small bowel, and increase the     rate of completion of capsule endoscopy.      The secondary objective is to determine whether patients could routinely tolerate this bowel     preparation prior to capsule endoscopy and whether the diagnostic yield of capsule endoscopy     is improved.   "
185684|NCT00275899|"     Decoy receptor 3 (DcR3), a new member of tumor necrosis factor receptor (TNFR) superfamily,     is a decoy receptor for FasL and could inhibit FasL-induced apoptosis, has recently been     shown to induce costimulation of T cells. Systemic lupus erythematosus (SLE) is an autoimmune     disease with pathogenic autoantibodies and immune complexes results from abnormal immune     responses including T and B lymphocyte hyperactivity, and formation of pathogenic subsets of     autoantibodies. Rhematoid arthritis (RA) is a multi-systemic autoimmune disease characterized     by persistent inflammatory synovitis. Activated T lymphocytes infiltration to synovium is     strongly correlated with the symptoms. DcR3 mRNA is expressed in peripheral-blood T cells and     is up-regulated after antigenic stimulation. The DcR3 gene has been demonstrated to be     overexpressed in patients with sclerosis or SLE; however, role of DcR3 in SLE and RA as well     as the effects of DcR3 on T cell immune response is still not clear. This study is to     investigate role of DcR3-induced T cell activation in SLE and RA. The genetic polymorphisms     of DcR3 in association with SLE and RA will be studied to elucidate the genetic factors     associated with development of SLE and RA. For further explore the possible molecular     mechanisms of elevated DcR3 in association with SLE, we attempt to study whether DcR3 could     induce T cell activation via costimualtion and/or inhibit the activation induced cell death     (AICD) of activated T cells in SLE and RA. This study will provide a new direction of therapy     in reverse T cell hyper-reactivity in SLE and RA.   "
185685|NCT00275912|"     This study is aimed to collect additional data regarding the efficacy in reducing the     frequency of partial seizures, as well as the safety and tolerability, of oxcarbazepine     monotherapy in children.   "
185687|NCT00275938|"     Hepatitis B virus (HBV) causes a wide spectrum of liver diseases, such as fulminant or acute     hepatitis, chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. The number of     individuals infected with this virus has been estimated to be as high as 350 million. Thus,     in addition to global hepatitis B vaccination, effective treatment of chronic hepatitis B is     also needed.      Currently, there are no effective antiviral treatments to cure HBV infection in patients with     chronic hepatitis B. Five drugs have been approved for the treatment of chronic hepatitis B     at present: conventional interferon (IFN) alpha, lamivudine, adefovir dipivoxil, pegylated     IFN alpha and recently entecavir. Overall, satisfactory virologic and serologic responses     could be achieved using pegylated IFN alpha alone in around 20-44% of these patients.     Nevertheless, better treatment options are still needed for the remaining >50%     non-responders.      Although the best treatment choice for chronic hepatitis B is not clarified yet, certain     therapeutic concepts could be derived from the experience of treating patients with chronic     hepatitis C. A major advancement in treating hepatitis C virus (HCV) infection has been the     development of combination therapy with IFN and ribavirin. IFN monotherapy is limited by poor     sustained virologic responses, even when higher doses of IFN are used. IFN plus ribavirin     combination therapy, in contrast, results in much improved treatment outcomes. In our     previous study and others, sustained remission rate after cessation of therapy were     significantly higher in patients receiving combination therapy than those receiving IFN     alone. Therefore, combination therapy with IFN and ribavirin has been recommended as the     standard treatment regimen for chronic hepatitis C. Furthermore, we have used ribavirin and     IFN combination for the treatment of dual chronic hepatitis B and C, and the results also     revealed that the efficacy of clearing HCV RNA was not affected by the presence of HBV     infection. Interestingly, after a little more than 2-year post-treatment follow-up, we found     that a significant portion (21%) of the responsive patients also cleared HBsAg. These     findings imply that this combination regimen might be also effective for the control of     chronic hepatitis B. We thus conducted a randomized, multi-center, placebo-controlled study     in patients with HBeAg-positive chronic hepatitis B.   "
185688|NCT00275951|"     The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL     may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.   "
185689|NCT00275964|"     Context:Clinical trials demonstrating increased risk of cardiovascular disease and breast     cancer among women randomized to hormone replacement therapy have attracted people's focus on     the alternative therapy for menopausal symptoms. This study drug- a mixture of     CHIA-WEI-HSIAO-YAO-SAN, CHIH-PO-TI-HUANG-WAN, HSIANG-SHA-LIU-CHUN-TZU-TANG (TMN1) is widely     used as an alternative to hormonal therapies for hot flush in Taiwan. However, there is a     paucity of data supporting their efficacy and safety.      Objective:To evaluate the safety and efficacy of TMN1 in the treatment of hot flush.      Design and Setting:A multi-center, prospective, observational follow-up study was conducted     from July 2003 to December 2004 in 4 hospitals.      Participants:In total, 136 eligible subjects entered this study. They were required to take     study drug 3 times a day for 12 weeks and make 9 visits at scheduled time for follow up     efficacy and safety evaluations.      Main Outcome Measures:During the observation period, the investigators and study nurses     actively enquired subjects if there was any adverse event (AEs) occurring to them by using     Traditional Chinese medicine Adverse Events (TCM AE) questionnaire which includes 20 AEs     proposed by experienced CM doctors as most commonly seen in the use of study drug. Every     subject's complaint or abnormal laboratory value were carefully examined for possible     causality and reviewed and decided by the research team. The primary outcome measure was the     mean changes from baseline to week 12 in terms of frequency of hot flush and the severity of     menopausal symptoms measured by the Kupperman Menopause Index. The secondary outcome measures     included changes in quality of life measured by World Health Organization Quality of Life     (WHOQOL) questionnaire, and adverse events monitored actively by a global assessment of     tolerability. During the study period, every subject also received tests on routine     hematology, biochemical function, and gynecologically relevant hormones at baseline visit, 4     weeks and 12 weeks after medication.   "
185690|NCT00275977|"     The aim of the study is to investigate whether infusion of autologous bone marrow derived     stem cells can improve cardiac function in the aftermath of a myocardial infarction.   "
185691|NCT00275990|"     The purpose of this study is to determine whether prompt removal of thrombus (blood clot)     from a blocked coronary artery using the AngioJet rheolytic thrombectomy device will result     in improved blood flow within the heart and a smaller final infarct size (reduced injury to     the heart muscle).   "
185692|NCT00276003|"     Primary objectives        -  Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins          disease, treated with the combination of the gemcitabine and irinotecan.      Secondary objectives        -  Assess progression free survival in these patients treated with this regimen.        -  Assess toxicity of this regimen in this group of patients.   "
185693|NCT00276016|"     This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover     study, conducted at a single site in Austria, outside of the normal grass pollen season. An     allergic reaction will be induced by exposing subjects to grass pollen in the Vienna     Challenge Chamber (VCC). Subjects will receive a single dose of each of the following     treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release     capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a     minimum of a 5-day washout period between each treatment. Subjects will complete symptom     evaluations throughout the study. The nasal decongestant effects of phenylephrine will be     compared to those of placebo using the subjective symptom evaluations. The safety profile     (adverse events and vital signs) of the treatments will also be evaluated.   "
185694|NCT00276029|"     The purpose of this study was to investigate whether the administration of etanercept to     patients with severe asthma improved their asthma related quality of life and a measure of     the degree of reactivity of the airways   "
185696|NCT00276055|"     1.1 To determine the recommended phase II dose for gemcitabine in combination with a fixed     dose of docetaxel and bevacizumab.      1.2 To determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab     in patients with soft tissue sarcoma 1.3 To determine the toxicity profile of the combination     of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma   "
185697|NCT00276068|"     The Vulvar Vestibulitis Clinical Trial (VVCT) a randomized, placebo-controlled, double     blinded clinical trial. We will study the clinical efficacy of four medical treatments for     vulvar vestibulitis: topical lidocaine, oral desipramine, combined lidocaine and desipramine,     and placebo cream and capsules. Desipramine is a tricyclic antidepressant commonly used by     clinicians for treatment of several chronic pain conditions that demonstrates an optimal side     effect profile compared to other tricyclic antidepressants. Topical lidocaine has also been     found to be beneficial for vulvar vestibulitis treatment in small studies. It is hypothesized     that the combined use of oral desipramine and topical lidocaine will be more therapeutically     effective than either one by itself and better than placebo.   "
185698|NCT00276081|"     To compare the efficacy and safety of gabapentin, estrogen and placebo in the treatment of     hot flashes and other climacteric symptoms.   "
185699|NCT00276094|"     The purpose of this study is to determine whether ospemifene is more effective than placebo     in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.   "
185700|NCT00276107|"     To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age.     To determine the antibody responses to the seven pneumococcal vaccine serotypes one month     after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6     months of age.   "
185705|NCT00276172|"     The primary objective of this study is to determine the safety and the immunogenicity of     extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV)     to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801,     C-1802, or C-1803.   "
185706|NCT00276185|"     Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This     study will test if botulinum toxin injections at earlier phases (<or = 3 months) in     spasticity improve functional and motor tests compared with late injections (>or = 6 months).   "
185707|NCT00276198|"     The objective of the program is to examine the efficacy of 6 month home micronutrient     supplementation in Bedouin and Jewish children on improvements in nutritional status     including measures of iron, ferritin, zinc and folic acid, and measures of growth and health     parameters i.e.reported and recorded morbidity.   "
185708|NCT00276211|"     This study is going to compare diffusionweigthed MRI scanning to the result of surgey in     patients with metastasis from brestcancer in the axilla   "
185709|NCT00276224|"     The objectives of this study is:        -  to establish the coverage rate of weekly iron supplementation in children in          intervention schools over a period of nine months        -  document any side effects of weeekly iron supplementation among children in intervention          schools over a period of nine months asses the feasibility of incorporating the weekly          iron supplementation programme into the normal school activity in intervention schools          determine the extent of acceptability and support for the iron supplementation programme          by staff at the health centre nearest to the intervention schools        -  compare the praziquantel efficacy and schistosomiasis reinfection in children in          intervention schools with that of children in control schools following the introduction          of weekely iron supplementation over a period of nine months        -  determine the impact of weekly iron supplementation on haemoglobin levels of children in          intervention schools and compare with children in control schools over a period of nine          months   "
185710|NCT00276237|"     One of the most common residual lesions in adult survivors of pediatric cardiac surgery is     pulmonary valve disease, particularly regurgitation.      Multiple studies have demonstrated that placement of a pulmonary valve in such patients,     results in improved ventricular function and resolution of symptoms. However, the optimal     prosthetic valve for use in the pulmonary position has not been defined. There are     essentially three alternatives available: the stented bioprosthetic valve, stentless     bioprosthetic tube grafts used to replace the entire right ventricular outflow tract and     mechanical valves.      All three of these valve options have been used in adults with congenital heart disease at     Emory Healthcare and at Children's Healthcare of Atlanta at Egleston.      The goal of this study is to evaluate and compare the indications and short and mid-term     outcomes for these alternative therapies.   "
185711|NCT00276250|"     Islet transplantation in type 1 diabetics with hypoglycemic unawareness using abatacept as a     part of a novel calcineurin-inhibitor-sparing immunosuppressive regimen.   "
185712|NCT00276263|"     The purpose of this study is to determine whether preventative treatment with sarcosine can     reduce symptoms and delay/avoid disease progression in individuals defined as being in a     prodromal stage of schizophrenia.   "
185713|NCT00276276|"     The purpose of this study is to find out if giving oral HYCAMTIN to patients with relapsed     small cell lung cancer benefits them. The study will compare how long patients live when they     are given therapy to make them feel better (active symptom control) to the length of time     patients live when they are also receiving oral HYCAMTIN.   "
185714|NCT00276289|"     Kidney stone formation due to an excess of calcium in the urine is a common problem. It is     treated with thiazide diuretics. These drugs often cause excessively low blood potassium     levels that in turn require large doses of potassium supplements. These supplements are often     large, unpleasant and easy to forget. We are trying the addition of spironolactone to these     patients' medications to see if it allows them to take a lower dose of potassium.   "
185715|NCT00276302|"     The primary objectives of the study are:        -  Determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS          patients who have failed prior therapies        -  Recommend a dose for subsequent studies of IPI-504   "
185716|NCT00276315|"     To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A     (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of     hemifacial spasm.   "
185717|NCT00276328|"     The purpose of this study is to evaluate whether Smecta® is more effective than placebo with     respect to time to recovery following an acute diarrhoea episode.   "
185718|NCT00276341|"     The purpose of this study is to determine whether the use of EGb 761 by patients with     Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to     placebo.   "
185719|NCT00276354|"     The main purpose of this study is to evaluate the tolerance of long term repeated doses of     Forlax® 10g versus lactulose in elderly ambulatory or institutionalized patients, paying     special attention to digestive and nutritional status.   "
185720|NCT00276367|"     A single post-hospital discharge home visit by a geriatric nurse practitioner or geriatric     fellow can bridge the gap and ease the transition for elderly frail patients returning home     after hospital admission. We believe this intervention will reduce medication errors, ensure     follow-up discharge plans, decrease re-hospitalization rates, and decrease morbidity and     mortality.   "
185721|NCT00276380|"     The purpose of this study is to evaluate the effectiveness of Tanakan® 240mg in association     with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following     ischemic stroke.   "
185722|NCT00276393|"     Patients with type 1 diabetes trained in multiple daily insulin injection were treated with     two diffferent kinds of long acting insulin preparations. The two insulin preparations were     glargine and ultralente insulin. Patients were randomized to receive one of the two insulin     preparations for the first 4 months followed by the second preparation for a further four     months. Short acting insulin used was the same during both periods. We found that glargine     insulin was better than ultralente insulin in our study.   "
185763|NCT00276952|"     The purpose of this study is to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in     the treatment of patients diagnosed with chronic tensional-type headache in accordance with     International Headache Society guidelines   "
185723|NCT00276406|"     Doctors at Mayo Clinic are doing this study to learn if pyridostigmine, a drug, affects the     speed at which food travels through the stomach, intestines and colon, and if pyridostigmine     improves constipation symptoms in patients with diabetes. Pyridostigmine has been approved by     the Food and Drug Administration (FDA) for routine clinical use, however, its use as proposed     in this study is considered investigational.   "
185724|NCT00276419|"     The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo     (10 weeks of each) for the treatment of noncyclic breast pain.   "
185725|NCT00276432|"     The primary outcome in this study will be time to discharge for low-risk patients and     therapeutic turnaround time for patients with NSTEMI or unstable angina.   "
185726|NCT00276445|"     Intravenous- injection of beta-1,3-glucan in human is known to induce T helper type 1     response, while oral uptake did not. It was examined whether superfine dispersed     beta-1,3-glucan (SDG) contrived to absorbed by intestinal mucosa would alleviate allergic     symptoms by per-oral ingestion   "
185727|NCT00276458|"     The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe     plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high     risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.   "
185728|NCT00276471|"     Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to     evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM     patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and     glycemic control.   "
185729|NCT00276484|"     To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus     Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not     Adequately Controlled on Atorvastatin 40 mg.   "
185730|NCT00276497|"     A three year prospective, double blinded, placebo controlled, randomized clinical trial in     impaired glucose tolerance (IGT) subjects to study the effect of pioglitazone in preventing     the conversion to Diabetes.   "
185731|NCT00276510|"     The purpose of this study is to determine whether Tanakan® is effective at slowing the     progression from memory complaint to dementia of Alzheimer's type.   "
185732|NCT00276523|"     RATIONALE: SCH 54031 (PEG-interferon alfa-2b) may interfere with the growth of tumor cells     and slow the growth of head and neck cancer. It may also stop the growth of head and neck     cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b before surgery may     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This randomized phase II trial is studying how well different doses of     PEG-interferon alfa-2b work in treating patients with stage II, stage III, or stage IV head     and neck cancer that can be removed by surgery.   "
185733|NCT00276536|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth     of cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in     treating patients with stage IV solid tumors, lymphoma, or myeloma.   "
185734|NCT00276549|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel     works in treating patients with metastatic prostate cancer.   "
185793|NCT00277355|"     This study is being conducted to assess the impact of minocycline on the progression of     symptoms of HD. The study will also assess whether it is reasonable to continue with further     study of minocycline in HD. We will measure the effect of minocycline on HD by measuring the     change in Huntington's disease symptoms.   "
185735|NCT00276575|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Erlotinib and everolimus may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab     and everolimus may also block blood flow to the tumor. Giving everolimus and erlotinib     together with bevacizumab may kill more tumor cells.      PURPOSE: This randomized phase I trial is studying the side effects and best dose of     erlotinib and everolimus when given together with bevacizumab in treating patients with     advanced solid tumors.   "
185736|NCT00276588|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with     carboplatin followed by paclitaxel works in treating patients with stage III or stage IV     non-small cell lung cancer.   "
185737|NCT00276601|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in     treating patients with acute promyelocytic leukemia.   "
185738|NCT00276614|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with     metastatic kidney cancer.   "
185739|NCT00276627|"     RATIONALE: A computer program and education materials may help improve the ability of doctors     to communicate with patients.      PURPOSE: This randomized clinical trial is studying how well a computer program together with     education materials works in improving communication between doctors and patients with stage     IV cancer.   "
185740|NCT00276640|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.      PURPOSE: This clinical trial is studying giving radiation therapy or combination chemotherapy     to see how well it works in treating patients with clinically or radiologically progressive     low-grade gliomas.   "
185741|NCT00276666|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as lomustine, vincristine, and cisplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving radiation therapy together with combination chemotherapy after surgery may kill any     tumor cells that remain.      PURPOSE: This phase II trial is studying giving radiation therapy together with combination     chemotherapy to see how well it works in treating young patients with metastatic     medulloblastoma who have undergone surgery.   "
185742|NCT00276679|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients     with high-risk relapsed or refractory neuroblastoma.   "
185743|NCT00276692|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with     newly diagnosed Ewing's sarcoma.   "
185744|NCT00276705|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and doxorubicin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.     Thalidomide may stop the growth of liver cancer by blocking blood flow to the tumor.     Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping     chemotherapy drugs near the tumor. Giving combination chemotherapy, thalidomide, and     chemoembolization before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed. Giving thalidomide together with chemotherapy after surgery     may kill any remaining tumor cells and prevent the tumor from coming back.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy and     thalidomide together with chemoembolization works in treating younger patients undergoing     surgery for newly diagnosed liver cancer.   "
185745|NCT00276718|"     RATIONALE: Drugs used in chemotherapy, such as etoposide, carboplatin, and bleomycin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells. Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed. Giving combination chemotherapy after     surgery may kill any tumor cells that remain.      PURPOSE: This clinical trial is studying how well giving etoposide, carboplatin, and     bleomycin works in treating young patients undergoing surgery for malignant germ cell tumors.   "
185746|NCT00276731|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs     to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     radiation therapy after surgery may kill any tumor cells that remain. It is not yet know     whether combination chemotherapy followed by surgery alone is more effective than combination     chemotherapy followed by surgery and radiation therapy in treating neuroblastoma.      PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by     surgery to see how well it works compared to combination chemotherapy followed by surgery and     radiation therapy in treating young patients with stage II or stage III neuroblastoma.   "
185747|NCT00276744|"     RATIONALE: Treating tumor tissue in the laboratory with different drugs may help doctors find     the best drug for treating individual patients with pancreatic cancer.      PURPOSE: This phase II trial is studying an individualized drug treatment selection process,     based on laboratory results, for treating patients with pancreatic cancer that can be removed     by surgery.   "
185748|NCT00276757|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of Langerhans     cell histiocytosis, either by killing the cells or by stopping them from dividing. Giving     more than one drug (combination chemotherapy) may be an effective treatment for Langerhans     cell histiocytosis.      PURPOSE: This randomized clinical trial is studying combination chemotherapy to see how well     it works in treating young patients with Langerhans cell histiocytosis.   "
185749|NCT00276770|"     RATIONALE: Diagnostic procedures, such as positron emission tomography using fluorothymidine     F 18, may be effective in finding recurrent disease in patients with gliomas.      PURPOSE: This clinical trial is studying how well positron emission tomography using     fluorothymidine F 18 works in finding recurrent disease in patients with gliomas.   "
185750|NCT00276783|"     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating     patients with recurrent malignant gliomas, primary CNS lymphoma, or brain metastases.   "
185751|NCT00276796|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel together with topotecan     and cisplatin works in treating patients with advanced, persistent, or recurrent cervical     cancer.   "
185764|NCT00276965|"     This study will compare the safety and effectiveness of a mood stabilizing medication, an     antidepressant medication, and a combination of both medications to treat symptoms of bipolar     type II depression.   "
185765|NCT00276978|"     20 therapy-refractory patients with major depression will be treated for 3 weeks with     Aripiprazole 10 mg/d. Effectivity will be assessed using a pre-post comparison of different     psychopathological rating scales and patient adherence.   "
185783|NCT00277225|"     The purpose of this protocol is to determine the single-dose pharmacokinetics and     immunogicity of BMS-188667 administered as a 1 hour intravenous infusion with extended     pharmacokinetic sampling. Safety of all subjects will be assessed in a double blind fashion     through the inclusion of placebo controls at each dose level.   "
195635|NCT00400387|"     With this clinical trial the investigators will analyze whether the rate of pregnancy losses     before the 24th week of gestation can be reduced by dalteparin treatment in habitual     aborters.   "
185752|NCT00276809|"     RATIONALE: Giving combination chemotherapy before a peripheral blood stem cell transplant     stops the growth of cancer cells by stopping them from dividing or killing them. Giving     colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells     move from the bone marrow to the blood so they can be collected and stored. A monoclonal     antibody, such as alemtuzumab, is given to kill any remaining cancer cells. Chemotherapy and     radiation therapy (total-body irradiation) are given to prepare the bone marrow for the stem     cell transplant. The stem cells are then returned to the patient to replace the blood-forming     cells that were destroyed by the chemotherapy and radiation therapy. Giving combination     chemotherapy, total-body irradiation, and alemtuzumab together with autologous peripheral     stem cell transplant may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with total-body irradiation and alemtuzumab works in treating patients undergoing an     autologous stem cell transplant for stage I, stage II, stage III, or stage IV chronic     lymphocytic leukemia.   "
185753|NCT00276822|"     RATIONALE: An education program based on patients' health communication needs may improve     patients' overall healthcare experience and sense of control.      PURPOSE: This clinical trial is studying the health communication needs of patients with     breast cancer to develop patient education programs.   "
185754|NCT00276835|"     RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Interleukin-2 may stimulate     the white blood cells, including natural killer cells, to kill melanoma or kidney cancer     cells. Giving genistein together with interleukin-2 may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving genistein together with     interleukin-2 works in treating patients with metastatic melanoma or kidney cancer.   "
185755|NCT00276848|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. It is not yet known whether giving fludarabine together with     cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic     leukemia.      PURPOSE: This randomized phase III trial is studying giving fludarabine together with     cyclophosphamide to see how well it works compared to fludarabine alone in treating patients     with advanced chronic lymphocytic leukemia.   "
185756|NCT00276861|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with     oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent     colon cancer.   "
185757|NCT00276874|"     Despite the many behavioral and cognitive treatment therapies that exist for cocaine     addiction, individuals who complete cocaine abuse treatment are still at high risk for     relapsing. Aripiprazole, a medication that is currently used to treat schizophrenia, may be     useful in preventing drug relapse in individuals addicted to cocaine. This three-part study     will evaluate the interaction between aripiprazole and cocaine. It will also determine the     safety and effectiveness of aripiprazole in preventing drug relapse among cocaine addicts.   "
185758|NCT00276887|"     This study will examine the long-term effects of cognitive behavioral therapy on the physical     symptoms, functioning, and health care utilization of people with multiple medically     unexplained physical symptoms.   "
185759|NCT00276900|"     This study will determine the effectiveness of taking sertraline within 24 hours of giving     birth in preventing a recurrence of postpartum depression.   "
185760|NCT00276913|"     Primary Objectives:        -  To determine the safety, toxicity and the maximum tolerated dose (MTD) of intravenous          STA-5312 when administered weekly (3 of 4 weeks) to subjects with advanced or metastatic          solid tumors.        -  To determine the pharmacokinetics of STA-5312.      Secondary Objective:      • To assess antitumor activity of STA-5312 administration.   "
185794|NCT00277368|"     The purpose of this study is to investigate the prevalence, characteristics and     classification of headaches in epileptic patients.   "
185807|NCT00277563|"     Pulsed electromagnetic fields (PEMF) have been approved by FDA and are utilized currently in     treating non-union fractures, neurogenic bladder and musculoskeletal pains. Based on 2 prior     pilot studies (open label) demonstrating reduction in neuropathic pain from carpal tunnel     syndrome we decided to perform a placebo-controlled trial, randomized for 2 months utilizing     a wrist PEMF device attached by Velcro for 4 hours/day.   "
185808|NCT00277576|"     The purpose of this study is to evaluate how well the vaccine is tolerated at sites where     administrations are given and any effects it may have on subjects' wellbeing. The study will     also test the ability of vaccine to reduce hepatitis B disease.   "
185761|NCT00276926|"     The purpose of this study is to assess the clinical anti-proliferative activity of STI571     (Glivec®, Novartis, Pharma) in patients with HES defined as:        1. Idiopathic Hypereosinophilic Syndrome (secondary HES), defined as a peripheral blood          eosinophilia greater than 1,500 cells/µL for longer than 6 months, absence of other          apparent aetiologies for eosinophilia and with or without signs and symptoms of organ          involvement, irrespective to expression of any of imatinib targets (c-Kit receptor,          PDGFR, bcr-abl receptor) on bone marrow cells.        2. Familiar hypereosinophilia defined as a peripheral blood eosinophilia greater than 1,500          cells/µL for longer than 6 months, absence of other apparent aetiologies for          eosinophilia and signs and symptoms of organ involvement, irrespective to expression of          any of imatinib targets (c-Kit receptor, PDGFR, bcr-abl receptor) on bone marrow cells,          and with a recognized or reported cases of hypereosinophilia in the patient's family.        3. Chronic myeloproliferative disorder, defined as chronic eosinophilic leukemia (CEL) with          the presence of blasts (>10%) in the bone marrow (BM), or the presence of immature          eosinophils in different tissues, or an aggressive clinical course or the presence of          clonal cytogenetic anomalies.        4. Myeloproliferative disorder (MPD) with eosinophilia, eosinophilic leukemia or chronic          myelomonocytic leukemia [myeloproliferative disorders/myelodysplastic syndromes          (MPD/MDS)] with evidence of:             -  t(5;12)(q33;p13) by cytogenetic or fluorescent in situ hybridization (FISH)               analysis, or             -  ETV6/TEL-PDGFRB fusion transcript by reverse transcription polymerase chain               reaction (RT-PCR), or             -  PDGFRB disruption, assessed or suspected, by other translocations with additional               partner genes (H4, HIP1, CEV14 and Rab5) 5, or             -  MPD/MDS who have constitutive activation of the gene for platelet-derived growth               factor receptor beta (PDGFRB) 6 by point mutations   "
185762|NCT00276939|"     The purpose of the study is to assess whether, in individuals with type 2 diabetes, a     low-fat, vegan diet improves blood glucose control more effectively than a control diet based     on current American Diabetes Association (ADA) guidelines. The principal measure is     hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The     study duration is 22 weeks with a one-year follow-up.   "
185781|NCT00277199|"     Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS-188667     in Healthy Subjects   "
185766|NCT00276991|"     This research work is important for the cure/control of HIV infection. The objectives of a     treatment case on HIV patient is essentially to bring down the viral load closer to     undetectable level. The studies are depend on the potential influence of 'Kallunk Oxide' on     the CD4+ T cells and the effectiveness on surface of HIV-1. The basic study is to break     surface protein and directly inhibit a protein's increased functions, not only in the CD4+T     cell but also CD3 and CD8+ T cells, by appropriate antidote.      The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and     lifestyle can be more easily studied.   "
185767|NCT00277004|"     Physiological Biomarkers of Cancer Treatment Related Fatigue in Women with Breast Cancer.   "
185768|NCT00277017|"     The purpose of this study is to evaluate a therapy combining the established FUNIL regimen     with Thalidomide. We want to see how well the therapy works, if it can be easily done, and     how well the body handles the treatment. We also wish to see if the addition of Thalidomide     will increase the effectiveness of the already established treatment regimen.   "
185769|NCT00277030|"     The purpose of this study is to compare two different treatment strategies for RDS in preterm     infants > 1500 grams and evaluate whether a selective surfactant administration would reduce     the need of intubation, mechanical ventilation and surfactant use.   "
185770|NCT00277043|"     The purpose of this study are to determine whether a test dose program for taxanes will     reduce the rate and/or severity of hypersensitivity reactions (HSR); and to determine whether     a test dose program for taxanes will result in cost reduction due to decreased drug wastage.   "
185771|NCT00277056|"     Dysregulated Tyrosine Kinase Signaling in Leukemia   "
185772|NCT00277069|"     1. Determine the response rate with this regimen in an anthracycline and taxane resistant     cohort of patients.   "
185773|NCT00277082|"     To determine the concentration of 9-nitrocamptothecin (9NC) in the alveolar fluid over time.      1.2. To determine the arterial concentration of 9NC administered by inhalation in comparison     to venous and urine concentrations.      1.3. To determine the tumor concentration of 9NC administered by inhalation   "
185774|NCT00277095|"     The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive     surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who     have stress urinary incontinence arising from intrinsic sphincter deficiency following an     operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two     adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress     incontinence.      The results will be analyzed to demonstrate the effects of the device as well as its     associated risks. Therapeutic success will be based on whether patients demonstrate at least     a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at     baseline.   "
185775|NCT00277108|"     The purpose of this study is to determine if Escitalopram (Lexapro) is effective in the     treatment of postpartum depression.   "
185776|NCT00277121|"     Several lipid disorders are without known genetic origin. The scope of this project is to     sequence genes superior involved in lipid and carbohydrate metabolism in patients with severe     lipid disorders. The resulting mutations will be tested in suitable in vitro systems to     detect their part in development of the specific disease.   "
185805|NCT00277537|"     Study will assess the safety and effectiveness of 12 week treatment with the study     medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have     trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol     inhalation may help to facilitate the clearance of mucus by altering its rheology (making it     less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On     completion of the double blind phase, subjects will have the opportunity to participate in a     52 week open label phase.   "
185806|NCT00277550|"     To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in     female patients with CC and upper GI symptoms of dyspepsia   "
185809|NCT00277589|"     Primary objective:        -  To evaluate change in total volume of all nodules.      Secondary objectives:        -  To evaluate change in goiter volume after a 12-months treatment, number of nodules and          echogenicity of nodules.   "
185777|NCT00277147|"     This study will evaluate a new (conjugate) vaccine for typhoid fever, which remains a serious     disease especially difficult to treat in developing countries. Salmonella typhi, the bacteria     causing typhoid fever, have become resistant to several antibiotics increasing the difficulty     of treating the disease. The disease may have serious complications effecting bones, brain,     and intestines, with permanent injury or death. Methods to control typhoid fever, such as a     sanitary water and food supply, along with effective sewage treatment, are not likely to be     available soon in those countries.      NIH scientists developed a vaccine called Vi, made of a polysaccharide (a chain of linked     sugars) from the surface of Salmonella typhi, the bacteria that cause typhoid fever. It has     been approved by the World Health Organization and is licensed in 94 countries. It is     effective in adults but not in young children. Clinical trials have shown that chemically     binding the Vi to a protein to form a conjugate vaccine has improved and extended its     efficacy to children (conjugate vaccines to other bacteria, notably meningitis causing     bacteria have been used extensively and successfully). Now NIH scientists have developed     another vaccine for typhoid fever - using a polysaccharide from fruit, known as pectin. The     pectin has been chemically treated so that it resembles Vi. The treated pectin, O-acetyl     pectin, is bound to a protein; exoprotein A, (rEPA). The result is a conjugate, as was formed     for Vi. Similarly to the Vi conjugate it induces antibodies against Salmonella typhi in     laboratory animals. If the O-acetyl pectin conjugate proves successful, it will be evaluated     in children ages 5 to 14 years old and in infants, toward using it with routine vaccines for     infants.      Volunteers ages 18 to 45 who do not have an allergy to fruit pectin and who have not been     vaccinated against nor had typhoid fever within the last 5 years may be eligible for this     study.      Volunteers will undergo several tests at their first visit to the clinic for this study. A     blood sample (about 2/3 of an ounce) will be taken to test for HIV, hepatitis B and C,     complete blood count, liver functions, blood chemistry and pregnancy in women of childbearing     age. The blood sample will also be tested for antibodies to Vi, rEPA (the protein of the     conjugate), and pectin. There will also be a urine collection for testing. If the laboratory     tests are acceptable, volunteers will be asked to return to the clinic on a...   "
185778|NCT00277160|"     The purpose of this study is to assess pegfilgrastim starting with the first cycle versus     secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays,     dose reductions, and hospitalizations) in older patients receiving chemotherapy.   "
185779|NCT00277173|"     The purpose of this study is to determine whether a CRM (adapted Crew Resource Management     approach proven successful in aviation as well as some inpatient medical settings)     intervention is effective for reducing medication errors among older adults in primary care     settings.   "
185780|NCT00277186|"     The study aims to determine if a New Arthroplasty Care Model, established on evidence-based     medicine and best practices, will improve patient outcomes and improve cost effectiveness for     patients with severe degenerative joint disease of the hip or knee in Alberta   "
185784|NCT00277238|"     The purpose of this study is to determine the efficacy and tolerability of CPG 10101 at two     different dose levels with pegylated-interferon-alpha 2B (PEG-IFN) plus ribavirin (RBV)     compared to PEG-IFN and RBV without CPG 10101 in HCV positive subjects who were classified as     non-responders to previous adequate PEG-IFN plus RBV therapy.   "
185785|NCT00277251|"     This trial will test the hypothesis that among 20 children and adolescents from Children's     Hospital, Boston with Crohn's disease, ulcerative colitis, systemic-onset juvenile rheumatoid     arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue     disease and vasculitis, treatment of glucocorticoid-associated osteopenia and osteoporosis     with 18 months of alendronate (FOSAMAX®, Merck & Co., Inc.) will result in greater     improvement in the mean change of individual AP spine bone mineral density (BMD) (gm/cm2)     determined by dual energy X-ray absorptiometry (DXA) than treatment with 18 months of     standard of care therapy.   "
185786|NCT00277264|"     The objective of this trial is to evaluate whether the effect of one year (48 weeks)     treatment with inhaled tiotropium bromide (Spiriva® - 18 µg once daily) on the change in     trough FEV1, compared to placebo in patients with COPD, is affected by smoking status.   "
185787|NCT00277277|"     The majority of patients with Type 2 Diabetes are obese and weight loss is known to improve     diabetes outcomes and reduce the need for anti-diabetic medical. This 8-week Telehealth study     will compare the effects of standard weight loss advice given in a clinic setting to weight     loss advice delivered in the home using an interactive cable television technology called     Healthium.   "
185788|NCT00277290|"     This clinical trial is being conducted at multiple sites to evaluate the activity, safety,     and tolerability of XL999 when given weekly to patients with ovarian cancer that has     previously been treated with platinum-based chemotherapy. XL999 is a small molecule inhibitor     of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor     cell growth, formation of new blood vessels (angiogenesis), and metastasis.   "
185789|NCT00277303|"     This clinical study is being conducted at multiple sites to determine the activity, safety,     and tolerability of XL999 when given weekly to patients with metastatic colorectal cancer     (CRC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR,     FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels     (angiogenesis), and metastasis.   "
185790|NCT00277316|"     This clinical study is being conducted at multiple sites to determine the activity, safety,     and tolerability of XL999 when given weekly to patients with metastatic clear cell renal cell     carcinoma (RCC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR,     PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood     vessels (angiogenesis), and metastasis.   "
185791|NCT00277329|"     This clinical study is being conducted at multiple sites to determine the activity, safety,     and tolerability of XL999 when given weekly to patients with non-small cell lung cancer     (NSCLC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR,     FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels     (angiogenesis), and metastasis.   "
185792|NCT00277342|"     The investigators hypothesise that a common A277G polymorphism of the liver fatty acid     binding protein (L-FABP) gene, which leads to an amino acid exchange, may be associated with     alterations of lipid-induced hepatic insulin resistance. In the present study the     investigators will investigate potential differences in lipid-induced hepatic insulin     resistance, and in the relation between glycogenolysis and gluconeogenesis, in healthy     subjects with the A277G polymorphism vs. subjects carrying the wildtype.   "
185795|NCT00277381|"     Treating hypertension is known to decrease morbidity and mortality. Despite this 70% of     patients do not have adequately controlled blood pressure. The main reason for this is     non-adherence to recommended drug therapy. Although strategies have been developed to improve     adherence many are time consuming and expensive. We propose to use communications technology     to develop a novel means of improving adherence to antihypertensive therapy. We will conduct     a randomised, single-blinded, controlled study to assess the impact of a real-time, automated     reminder system on adherence rates. This will involve adapting two pieces of currently     available technology - the electronic pill bottle and the Ambient Globe. The Globe will     change colour in response to information received, via a wireless link, from the patient's     electronic pill bottle. We hypothesise that this will provide patients with an up to date,     but unobtrusive, reminder of their adherence status and thus effect positive behavioural     change. We will measure the impact of this intervention on adherence rates as well as     assessing patient views and the impact on provider workload. This trial will elucidate the     role of communications technology in improving adherence behaviour and allow us to develop     further strategies to tackle this major health issue.   "
185796|NCT00277394|"     The objective of the study is to compare the safety of innohep® and Unfractionated Heparin     (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal     function for initial treatment of acute Deep Venous Thrombosis (DVT).      The primary response criterion is the percentage of patients with clinically relevant     bleeding events prior to day 90 +/- 5.   "
185797|NCT00277407|"     1. Purpose of this study is to determine whether NAET procedures are effective in the          treatment of children with allergy-related autism spectrum disorders in restoring their          verbal and nonverbal communication.        2. Hypothesis: Children in the experimental group will show a significant improvement over          the control group in verbal and nonverbal communication as most food allergen groups,          environmental allergen groups, childhood immunizations, and some other relevant          allergenic substances are desensitized in a systematic way using NAET® procedures within          the specified period of study.   "
185798|NCT00277420|"     This project aims to conduct a unique, community-based intervention consisting of a     randomized trial of a culturally-appropriate weight loss intervention for overweight Latino     children in Milwaukee. The intervention promotes lifestyle changes through a low weight loss     regimen, one or more physical activities ranging from soccer to hip-hop dance, and dietary     counseling including cooking classes for parents. In addition to weight reduction for     overweight Latino children, the project has the potential to reduce missed school days and     improve self-esteem and quality of life.   "
197935|NCT00431041|"     The purpose of this study is to compare the safety and efficacy of solifenacin with     oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).   "
185800|NCT00277446|"     An epidemiologic study of patients with asthma has shown that increased intake of soy     isoflavones correlates with less severe asthma. In experimental animals, treatment with the     soy isoflavone genistein reduces airways inflammation and hyper-responsiveness. In vitro     studies performed by us have shows that genistein reduces release of inflammatory compounds     by human blood eosinophils. The purpose of this pilot study is to determine whether dietary     supplementation with soy isoflavones has effects in patients with asthma. 20 patients with     asthma will supplement their diet with a soy isoflavone capsule for 4 weeks. Before and after     the supplementation period, we will measure lung function, exhaled nitric oxide (a marker for     airway inflammation), collect exhaled breath condensate to measure levels of inflammatory     mediators in the airways, and isolate peripheral blood eosinophils to assess the impact of     soy isoflavones on their function. We hypothesize that dietary supplementation with soy     isoflavones will reduce exhaled nitric oxide level, reduce the inflammatory mediators in the     exhaled breath condensate, and reduce the ability of eosinophils to release inflammatory     molecules. Identifying if these hypothesized effects of soy isoflavones exist in asthma will     provide a justification for further clinical studies.   "
185801|NCT00277472|"     This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination     therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.   "
185802|NCT00277498|"     To demonstrate statistical superiority of the combination of latanoprost and timolol to the     individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8     AM, 10 AM, 4 PM at weeks 2, 6 and 12.   "
185803|NCT00277511|"     Primary objective:        -  To investigate the microbiological efficacy, assessed as eradication rate based on          microbiologically evaluable patients 1 month post treatment with oral Levofloxacin 500          mg in male adults with chronic bacterial prostatitis (CBP, category II)      Secondary objectives:        -  To investigate the microbiological efficacy, assessed as eradication rate based on          microbiologically evaluable patients 6 months post treatment with oral Levofloxacin 500          mg in male adults with chronic bacterial prostatitis (CBP, category II).        -  To assess the clinical response rate based on resolution of signs and symptoms after 2          weeks of treatment; 5-12 days, 1 month, 3 months and 6 months post treatment with oral          Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category          II).        -  To assess the safety of Levofloxacin 500 mg on the basis of adverse events, standard          clinical chemistry, hematology, urinalysis and vital signs in male adults with chronic          bacterial prostatitis (CBP, category II).   "
185804|NCT00277524|"     The purpose of the OMNI study is to characterize therapy and diagnostic utilization in study     participants implanted with study devices and to describe Implantable Cardioverter     Defibrillator(ICD)therapy utilization for life threatening arrhythmias in primary and     secondary prevention study participants. This study will assess therapies in Medtronic     pacemaker, defibrillator, and cardiac resynchronization therapy devices.      The first therapy is for reducing unnecessary pacing in pacemaker patients. The second     therapy provides pacing therapy in an attempt to stop fast or life threatening ventricular     arrhythmias in lieu of delivering a defibrillation shock. The third therapy is a diagnostic     measurement of a patient's fluid status and provides the physician information on the     patient's heart failure status.      The study will also assess the time to a patient's first defibrillation shock and will verify     that the shock was for a fast or life threatening ventricular rhythm.   "
185810|NCT00277602|"     Primary objective:        -  The primary objective of the study is to establish that riluzole slows down (1) the          decrease in total functional capacity (TFC), (2) the increase of the motor score of the          Unified Huntington's Disease Rating Scale (UHDRS) as well as (3) the increase of a          combined score of these.      Secondary objectives:      Secondary objectives are to assess        -  changes in the other UHDRS subscales        -  the number of patients who need antichoreic treatment and the time until this treatment          has to be initiated        -  the safety/tolerability of riluzole in Huntington patients   "
185811|NCT00277615|"     The purpose of this study is to evaluate a novel ultrasound bladder scanning device designed     particularly for children in children with bladder dysfunction.   "
185812|NCT00277641|"     This research study is to evaluate the effectiveness, tolerability, and safety of lamotrigine     therapy in the treatment of binge eating disorder associated with obesity.      Lamotrigine has been approved by the Food and Drug Administration for the treatment of     bipolar disorder, but has not been approved for use in the treatment of binge eating disorder     with obesity.   "
185813|NCT00277654|"     The purpose of this research study is to evaluate the safety, tolerability, and efficacy (how     well the drug works) of risperidone compared to placebo (an inactive drug) in the treatment     of bipolar disorder with panic disorder or generalized anxiety disorder. Risperidone is     currently approved by the United States Food and Drug Administration (FDA) for the treatment     of schizophrenia and bipolar mania. Risperidone is not currently FDA approved for the     treatment of bipolar hypomania with or without panic disorder or generalized anxiety disorder     (the condition being investigated in this study).   "
185814|NCT00277667|"     The purpose of this research study is to evaluate the safety, tolerability, and efficacy of     quetiapine compared to placebo (sugar pill without medication) in the treatment of bipolar     disorder with moderate to severe hypomania or mild mania. Quetiapine is approved by the     United States Food and Drug Administration (FDA) for the treatment of schizophrenia and     bipolar mania.   "
185815|NCT00277680|"     Women with symptomatic uterine fibroids are treated either by Uterine Fibroid Embolization     (UFE) or laparoscopic occlusion. The study hypothesis is that laparoscopic occlusion of     uterine vessels and UFE have equal effect on bleeding symptoms. Menstrual bleeding reduction     six months after treatment is the main endpoint. Secondary endpoints include participants     assessment of symptom relief, and volume reduction of fibroids measured by MRI. We will also     investigate possible differences in postoperative course, symptom reduction, complication,     and recurrence. Patients are controlled with regular intervals up to five years after     treatment.   "
185816|NCT00277693|"     The purpose of the present study is to determine if spironolactone is safe and effective in     the treatment of cardiovascular complications in hemodialysis patients.   "
198540|NCT00447005|"     To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by     reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.   "
185817|NCT00277706|"     Parathyroid hormone (PTH) has potent bone-building actions and has been approved for the     treatment of osteoporosis as FORTEO by Eli Lilly & Co. Numerous studies have verified its     effectiveness in increasing bone mass and potential for PTH to positively impact oral bone.     The hypothesis of this study is that patients administered FORTEO along with periodontal     (gum) surgery will respond more favorably than patients who receive placebo.      There will be 40 subjects enrolled in this study. All subjects will receive surgical     treatment. 20 subjects will receive FORTEO and 20 will receive placebo. Subjects will be     assigned to study group randomly. Neither the subjects nor the clinicians will know whether     the subject is receiving FORTEO or placebo.      Patients will undergo routine periodontal treatment procedures including periodontal surgery.     Starting from 3 days prior to surgery, all subjects will self-administer FORTEO or placebo     for 6 weeks. Subjects will be trained for self-administration, a procedure similar to     diabetic injections. Patients will also take Vitamin D and Calcium by mouth during this time.     Study outcomes will be measured by blood collection; oral fluid sampling; oral x-ray and     spine and hip bone density scan; routine periodontal examinations; and an oral health quality     of life questionnaire.      Patients of both genders and all ethnicities from age 30-75 years will be included in the     study. All ethnicities are eligible for entry into study. No vulnerable populations will be     included. Pregnant/breast-feeding women and women of childbearing potential on no     contraception will be excluded from the study. Research records will not be linkable to the     research subjects. Subjects will be randomly assigned to treatment arms and identified by     initials and numbers. Informed consent forms will be used to obtain consent for participation     in the study from all subjects prior to enrollment. The Principal Investigator or     Co-Investigator will explain the details of study involvement and give subjects ample     opportunity to ask questions.      It is anticipated that patients on FORTEO will have greater regeneration with periodontal     therapy as compared to control patients.   "
185818|NCT00277732|"     The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity     of pharmaceutical care for diabetes type 2 patients. Patients will be randomly allocated to     the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical     care at baseline and follow-up visits over 6 months).   "
185819|NCT00277745|"     This study is being conducted to test the ability and accuracy of a new instrument in the     diagnosis of periodontitis (gum disease) by using fluids from the mouth. The diagnosis     instrument will test two types of fluids, gingival crevicular fluid (GCF) and saliva. GCF is     the fluid that accumulates between your teeth and gum tissue. The fluids will be collected in     three ways: 1. Direct GCF sampling 2. GCF rinse sampling and 3. Whole saliva. A total of 100     adult patients will participate in this study. These subjects will be of two patient     populations: 1) diseased population, with active gum disease; and 2) a low-risk disease     population, with no active gum disease. Patients will be seen 6 times over the course of the     study over a period of approximately 12 months. At each visit the patient will undergo oral     fluid collection, as previously described, and thorough examinations of the mouth, including     the taking of measurements for study purposes. Patients will also have radiographs taken at     baseline, month 6, and end of study visits.   "
185820|NCT00277758|"     This is a treatment study trial, in which we will assess the safety and tolerability of daily     dose IL-2, as monotherapy for 12 weeks, followed by IL2 in combination with PEG-IFN and RBV     for 48 weeks in the treatment of chronic Hepatitis C.   "
185821|NCT00277771|"     We propose to conduct a randomized study of standard behavioral weight-loss treatment to test     if using an electronic diary with or without tailored feedback will improve adherence to     self-monitoring and subsequently improve weight loss. Subjects will be randomly assigned to     different methods to self-monitor food and exercise habits: (1) use of the traditional paper     diary , (2) use of a personal digital assistant (PDA), or (3) use of a personal digital     assistant that also provides daily feedback.   "
185864|NCT00278369|"     RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry     tumor-killing substances directly to kidney cancer cells. Interleukin-2 may stimulate the     white blood cells to kill kidney cancer cells. Giving denileukin diftitox together with     interleukin-2 may kill more tumor cells.      PURPOSE: This randomized phase I trial is studying the side effects of denileukin diftitox     and interleukin-2 in treating patients with metastatic kidney cancer.   "
185822|NCT00277784|"     The macula is the site of central vision within the retina. The retina is oxygenated by the     underlying choroid. These tissues are less than 1 mm thick in total. While optical techniques     can reveal much about the structure of the retina, ultrasound allows imaging of the choroid     and deeper tissues. This study will investigate use of high frequency (20 MHz) ultrasound for     imaging of the retina and choroid in patients with age-related macular degeneration, a prime     cause of blindness. The investigation will involve use of novel post-processing methodologies     to achieve maximum resolution of the fine tissue structures involved in this disease.   "
185823|NCT00277797|"     Low back pain is a common condition, which extols a large cost to society from lost wages      The Biowave System was developed by Biowave Corporation (Biowave), Norwalk, CT. Two wires     emanate from the unit. The feed wire is attached to a large disposable input pad (Feed     Electrode). The return wire is attached to a smaller pad (Return Electrode) over the     source of the pain (the treatment site).      The device sends a premixed modulated envelope of two high frequency electronic wave forms     (Feed Signal) between the two electrodes. The beat frequency of the modulated envelope     (d-Frequency) is equal to the difference in frequency of the two feed signals. The location     of beat frequency formation is dependent on the size and location of the two electrodes. With     the configuration used in the study, the beat frequency signal is believed to form     immediately ventrally to the Return electrode. The size of the volume of tissue affected can     be changed and is dependent upon electrode geometry and the amplitude of the Feed Signal. The     beat frequency is a low frequency blocking signal which is believed to cause a demodulation     in the nerve cells and a reduction of the sodium/potassium ion exchange. As a result, the     charge polarity of the nerve cell wall is prevented from changing and is therefore unable to     transmit pain impulses. The size of the volume of tissue affected can be changed and is     dependent upon electrode geometry and the amplitude of the Feed Signal.      The objective of this study is to compare the Biowave System with TENS (a currently available     treatment) and to further evaluate its efficacy for the relief of pain in patients with     chronic low back pain.   "
185824|NCT00277810|"     The purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of     lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate     Alzheimer's disease (AD).   "
185825|NCT00277823|"     The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability     of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects     receiving placebo.   "
186013|NCT00271791|"     The purpose of the study is to investigate the value of steroids in the treatment of     vestibular neuronitis. The potential benefits of steroid therapy would be analyzed by the     clinical response, self-perceived handicap and laboratory parameters.   "
185826|NCT00277836|"     MST-997 is a taxane analog with the potential to treat subjects with a variety of tumor     types. Preclinical data demonstrated that MST-997 inhibited tumor growth when administered     intravenously (IV). This phase 1 dose escalation study is designed to evaluate the safety and     tolerability of if IV MST-997 formulated in Polysorbate 80 Diluent can be safely administered     on a weekly basis.   "
185827|NCT00277849|"     This study will collect blood samples for use in laboratory studies of malaria. The World     Health Organization reports that 40 percent of the world's population is at risk for malaria,     mostly in the poorest countries. It is a serious disease caused by parasites. Each year,     300-500 million infections lead to more than a million deaths. However, there are traits in     red blood cells (erythrocyte) that protect people against malaria. In this study,     polymorphism refers to the various kinds of red blood cell traits.      The sickle cell trait is an example of one that seems to offer a natural survival advantage     in children where malaria is common. Researchers at the Laboratory of Malaria and Vector     Research are investigating ways in which the blood cell traits can offer such protection, and     new knowledge gained can bring about medical advances. Of particular importance is studying     how the malaria organism, Plasmodium, survives inside different red blood cells. A steady,     consistent, and reliable supply of fresh whole blood is necessary for testing.      Patients 18 to 65, weighing more than 110 lbs. and who do not have anemia or known HIV,     Hepatitis C, or Hepatitis B may be eligible for this study.      Patients will undergo a medical history and general assessment including vital signs of     temperature, heart rate, and blood pressure. Blood will be collected from a vein in the arm,     or rarely a vein in the hand. A complete blood count, or CBC, will be done to ensure that     blood levels are sufficient and that blood donation is safe for a patient to do. Patients     need to have enough hemoglobin, the part of red blood cells that transports oxygen throughout     the body. The blood will also be tested to confirm the type of red blood cell traits of     patients. About 1 to 8 tablespoons may be collected, but most blood samples will be small,     that is, 1 to 4 teaspoons. After the patients' first visit, sessions will take 5-20 minutes.     Blood collection will total no more than 2 cups from a donor during any 6-week period.     Although the frequency of blood donations is not known at this time, it is unlikely that a     patient will be asked to donate blood more than four times a year. It may be important for     patients to undergo a repeat CBC or tests for blood chemistry if results are needed for     research. Risks associated with blood collection are considered minimal. They include     discomfort, occasional bruising or bleeding at the puncture site, and faintness.      In this study, it is possible that a small amount of blood may be stored for future research,     to help the researchers to learn more about malaria. There are no plans for the results from     the various research laboratory tests to be made available to patients or to their private     doctors. However, patients in this study may discuss the results of routine medical tests     with the study investigators. Some of the blood collected will be tested for genetic     conditions. Through genetic testing, researchers can learn more about how health or illness     may be passed on to people by their parents, or from people to their children. All results of     tests will remain confidential. Blood samples will be labeled by code, and reference to     patients' identities will be protected.      Participants will receive $50 for each blood donation. This study will not have a direct     benefit for participants. Future research that uses their blood samples will help researchers     to learn about malaria as well as how to prevent or treat the disease.   "
185828|NCT00277862|"     Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to     treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to     conventional interferon monotherapy. Recent reports showed that pegylated interferon and     ribavirin combination therapy markedly increased the SVR rate to 55-70%. The duration of     treatment has not been accurately defined. The main objective of this is to assess the     duration of pegylated interferon ribavirin therapy in chronic hepatitis genotype 4 and assess     the clinical utility of rapid and early virologic response in determining the optimal     duration of peg interferon ribavirin therapy in chronic hepatitis C.   "
185829|NCT00277875|"     Determine whether increasing arterial distensibility by decreasing advanced glycation     end-product (AGE) cross-link components of vascular stiffness improves (a)     endothelial-mediated vasoreactivity at rest, as assessed by flow-mediated vasodilation (FMD),     and (b) endothelial-mediated vasoreactivity after exercise, as assessed by pulse     perfusion-mediated vasodilation (PPMV).   "
185830|NCT00277888|"     The purpose of this study is to determine whether a jugular route leads to a lower rate of     complications as compared with a femoral route for catheterization in patients admitted in     several intensive care units in France who develop acute renal failure requiring     hemodiafiltration or hemodialysis.   "
185831|NCT00277901|"     At Children's Healthcare of Atlanta at Egleston, it is standard of care to do a cardiac MRI     on patients with the diagnosis of Tetralogy of Fallot and Aortic Coarctation to evaluate     heart function. We propose to do a retrospective chart review of patient data along with     their MRI data to analyze ventricular function and cavity volumes pre-Tetralogy of Fallot     repair, post-Tetralogy of Fallot repair (pre-valve repair/replacement) and post-valve     repair/replacement in order to assess the efficacy and optimal timing of valve replacement.   "
185832|NCT00277914|"     To estimate the duration of efficacy with continued treatment of double-blind flibanserin or     placebo over twenty-four weeks of treatment.   "
185833|NCT00277927|"     Mild valvar pulmonary stenosis can be detected in 1/10,000 live births. Historical data     suggested that most of these patients do well. Nonetheless, the majority of these patients is     followed periodically by a pediatric cardiologist and may undergo repeated echocardiographic     studies to follow the gradient. Such follow-up can be costly and it is not know if there is     any benefit to periodic evaluation.   "
185834|NCT00277940|"     Abnormalities of the aorta have been identified in patients who have undergone repair of     coarctation of the aorta by various surgical techniques. These abnormalities are thought to     contribute to ventricular hypertrophy, hypertension and exercise intolerance. Aortic arch     reconstruction is performed for a variety of lesions besides simple coarctation of the aorta;     these include hypoplastic left heart syndrome and its variants. In the latter group of     patients extensive reconstruction is performed usually with a pulmonary homograft. We have     previously shown that the neo-aortic dimensions and geometry are abnormal. The elastic     properties of the neo-aorta, however, have not previously been described.   "
185862|NCT00278330|"     This phase I trial is studying the side effects and best dose of flavopiridol when given     together with vorinostat in treating patients with relapsed or refractory acute leukemia or     chronic myelogenous leukemia or refractory anemia. Flavopiridol and vorinostat may cause     leukemia cells to look more like normal cells, and to grow and spread more slowly. Vorinostat     may also stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth. Giving flavopiridol together with vorinostat may be an effective treatment for     leukemia or refractory anemia.   "
185835|NCT00277953|"     To date, there have been no published reports of normal variations in tracheal dimensions for     pediatric patients undergoing MRIs. While there are reports of normals in CT studies, the     reported dimensions were for average areas and lengths over the entire length of the trachea     and not for normal variation in the dimensions at various sites in the trachea. Moreover, CT     measurements are likely not entirely applicable to MRI measurements. Since cardiac MRI has     become the procedure of choice to document the presence of vascular rings as well as the     significance of any ring that is found, there is a need for normal values to be generated.     This would in turn permit physicians to determine in cases of documented vascular rings the     severity of the tracheal stenosis/deformity if found.   "
185836|NCT00277966|"     In 2004, the Cardiac Cath Lab at Children's Healthcare of Atlanta was asked to conduct a     Quality Improvement Review examining radiation exposure.   "
185837|NCT00277979|"     Pompe's disease, also known as glycogen storage disease type II, is a genetic disorder due to     deficiency of acid glucosidase (GAA), which results in lysosomal glycogen storage in various     tissues.      Very low levels of GAA usually present in infancy, lead to a progressive cardiac and skeletal     muscle disorder and death before age 1 year.      Most infants develop massive hypertrophic cardiomyopathy which progresses to dilated     cardiomyopathy and cardiorespiratory arrest.      3D echocardiography can be a simple, non-invasive method of following cardiac disease     progression in infantile Pompe's disease.   "
185838|NCT00277992|"     Children with HLHS have a history of poor enteral intake and growth. Over the past several     years a modification to the Norwood operation was instituted (RV to PA shunt in place of the     standard Blalock-Taussig shunt).      The purpose of this study is to evaluate whether children who underwent this modification of     the Norwood procedure had improved growth compared to those in past years who underwent     traditional Norwood.   "
185839|NCT00278005|"     We propose a retrospective review of patients with DiGeorge syndrome having undergone cardiac     surgery to evaluate the incidence of blood stream and/or surgical site infection. The     hypothesis is that we will find an increased number of infections for this sub-group. We will     compare the incidence of infection to children of similar age and diagnosis to evaluate for     variances in the incidence of infection.   "
186014|NCT00271804|"     The purpose of this study is to find out what the maximal tolerated dose of Velcade can be     given with thalidomide in patients with myelodysplasia.   "
185840|NCT00278018|"     Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized,     this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy     represents an approach to treatment based on the immune response to cancer antigens.      The long-term objective of this study is to develop a therapeutic approach for the treatment     of cancer in general, and melanoma in particular, based on immunotherapy, using a combination     of local tumor irradiation followed by injection of immature dendritic cells (iDC).The     treatment will be followed by the injection of interferon alpha, which we expect will induce     activation of the iDC.      This trial is based on the hypothesis that local radiation, which causes destruction of the     tumor, in combination with injection of the patient's own iDC and the activation of these     cells with interferon alpha, will induce an effective immune response against the tumor. In     order to test the suggested approach, we propose a 20-patients clinical trial that will     evaluate the objective clinical and immunological response to the proposed treatment in     patients with malignant melanoma and other solid tumors.   "
185841|NCT00278031|"     The aim of the study is to assess the quality of life of children who have been cured of     retinoblastoma - a malignant eye tumor. The study is questionnaire-based, and uses     standardized quality of life assessment tools.   "
185842|NCT00278044|"     Study the clinical manifestations and gene mutation of Taiwanese ALD patients   "
185843|NCT00278057|"     We wanted to test the hypotheses that blood pressure level was lower, that the variability of     blood pressure and blood glucose was reduced, and that quality of life was improved when     glucose was added to the dialysis fluid.   "
185844|NCT00278070|"     Patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of three     different doses (30 or 40 or 50 mg). Vinorelbine will be administered orally at a metronomic     schedule three times a week: on Monday, Wednesday and Friday.   "
185845|NCT00278083|"     This trial is a randomised, single-center, placebo-controlled, double blind, parallel group     study in patients with asthma symptomatic on inhaled steroids.      This trial will examine the efficacy and safety of 5 mg/kg doses of infliximab in patients     with inhaled corticosteroid-dependent asthma. The primary objective of this study is to     obtain pharmacological evidence for a role of the pro-inflammatory cytokine TNF-alpha in     patients with asthma symptomatic on inhaled steroids and to evaluate the safety and     tolerability of repeated intravenous administration of infliximab.   "
185846|NCT00278096|"     In this study we aim to assess whether unsolicited occupational therapy compared to no     therapy can decelerate the increase in disability in high-risk elderly.   "
185847|NCT00278109|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as cyclophosphamide and doxorubicin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     radiation therapy together with cyclophosphamide and doxorubicin after surgery may kill any     tumor cells that remain.      PURPOSE: This phase I/II trial is studying the side effects of radiation therapy when given     together with cyclophosphamide and doxorubicin and to see how well they work in treating     women with stage I or stage II breast cancer who have undergone surgery.   "
185848|NCT00278122|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and     stop tumor cells from growing. Giving paclitaxel together with GM-CSF may be effective in     treating melanoma.      PURPOSE: This phase II trial is studying how well giving paclitaxel together with GM-CSF     works in treating patients with stage III or stage IV melanoma that cannot be removed by     surgery.   "
185849|NCT00278135|"     The purpose of this study is to investigate the effect of docosahexaenoic acid (DHA, 22:6n-3)     in improving cognitive functions in subjects with age-related cognitive decline. DHA is a     long chain omega-3 fatty acid (LC-PUFA) that plays an important role in neural and visual     development and cardiovascular health.   "
185850|NCT00278148|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving erlotinib, paclitaxel, and carboplatin together with radiation therapy before surgery     may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.     Giving these treatments after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase I/II trial is studying the best dose of erlotinib and the side effects of     erlotinib, paclitaxel, and carboplatin when given together with radiation therapy and to see     how well they work in treating patients who are undergoing surgery for stage III non-small     cell lung cancer.   "
185851|NCT00278161|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Colony-stimulating factors, such as     pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral     blood and may help the immune system recover from the side effects of chemotherapy. Giving     rituximab and cyclophosphamide together with pegfilgrastim may be effective in treating     leukemia or non-Hodgkin's lymphoma.      PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide     together with pegfilgrastim works in treating patients with B-cell leukemia, low-grade     non-Hodgkin's lymphoma, or mantle cell lymphoma.   "
185852|NCT00278174|"     RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth     of kidney cancer.      PURPOSE: This phase II trial is studying how well interferon alfa works in treating patients     with metastatic kidney cancer.   "
185881|NCT00270049|"     The purpose of this study is to evaluate the effect of treatment with epoetin alfa versus     placebo on the percentage of red blood cells in anemic patients with chronic lymphocytic     (white blood cell) leukemia and its effect on the patients' quality-of-life. Epoetin alfa is     a genetically engineered protein that stimulates red blood cell production.   "
185853|NCT00278187|"     RATIONALE: Monoclonal antibodies, such as volociximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Volociximab may also stop the     growth of non-small cell lung cancer by blocking blood flow to the tumor. Erlotinib may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     volociximab together with erlotinib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving volociximab together with erlotinib     works in treating patients with stage III or stage IV non-small cell lung cancer.   "
185854|NCT00278200|"     RATIONALE: Vaccines made from a person's white blood cells may help the body build an     effective immune response.      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating     patients who are being considered for solid organ transplant who are at risk for     post-transplant lymphoproliferative disorder.   "
185855|NCT00278213|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and     mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Giving more than one drug (combination     chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as alemtuzumab, can     block cancer growth in different ways. Some block the ability of cancer cells to grow and     spread. Others can find cancer cells and help kill them or carry cancer-killing substances to     them. Combination chemotherapy followed by alemtuzumab may be effective in treating chronic     lymphocytic leukemia and prolymphocytic leukemia.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by     alemtuzumab works in treating patients with T-cell chronic lymphocytic leukemia or     prolymphocytic leukemia.   "
185856|NCT00278226|"     RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer from     forming.      PURPOSE: This clinical trial is studying how well a motivational program works in helping     smokers enrolled in a methadone maintenance program quit smoking.   "
185857|NCT00278239|"     RATIONALE: Questionnaires that measure quality of life may improve the ability to plan     treatment for patients with primitive neuroectodermal tumors.      PURPOSE: This phase III trial is studying quality of life in patients who have undergone     previous treatment for primitive neuroectodermal tumors.   "
185858|NCT00278252|"     RATIONALE: Drugs used in chemotherapy, such as etoposide, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well etoposide works in treating young patients     with ependymoma.   "
185859|NCT00278265|"     RATIONALE: Drugs used in chemotherapy, such as methotrexate and fludarabine, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing.      PURPOSE: This phase II trial is studying how well methotrexate works as first-line therapy     and fludarabine works as second-line therapy in treating patients with T-cell large granular     lymphocytic leukemia.   "
185860|NCT00278278|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy     x-rays to kill tumor cells. It is not yet known whether giving methotrexate together with     combination chemotherapy and radiation therapy is more effective than combination     chemotherapy and radiation therapy alone in treating gliomas.      PURPOSE: This randomized phase III trial is studying giving methotrexate together with     combination chemotherapy and radiation therapy to see how well it works compared to     combination chemotherapy and radiation therapy alone in treating young patients with newly     diagnosed gliomas.   "
185861|NCT00278304|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation     uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving     radiation therapy in different ways may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving external-beam radiation together     with internal radiation works in treating patients with cervical cancer.   "
185863|NCT00278343|"     This phase II trial is studying how well cediranib maleate works in treating patients with     persistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, or     fallopian tube cancer. Cediranib maleate may stop the growth of tumor cells by blocking blood     flow to the tumor and by blocking some of the enzymes needed for cell growth.   "
185865|NCT00278382|"     Sorafenib may stop the growth of cancer cells by blocking blood flow to the cancer and by     blocking some of the enzymes needed for cell growth. This phase II trial is studying how well     sorafenib works in treating patients with chemosensitive recurrent aggressive non-Hodgkin's     lymphoma   "
185866|NCT00278395|"     This phase II trial is studying how well vorinostat works in treating patients with advanced     kidney cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Vorinostat may also stop the growth of tumor cells by blocking blood flow to the tumor.   "
185867|NCT00278408|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,     such as cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving     rituximab and combination chemotherapy together with radiation therapy may kill more cancer     cells. It is not yet known which schedule of rituximab and combination chemotherapy is more     effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and     combination chemotherapy with or without radiation therapy to compare how well they work in     treating patients with aggressive B-cell non-Hodgkin's lymphoma.   "
185882|NCT00270062|"     The purpose of this study is to evaluate the safety of epoetin alfa and its effectiveness in     facilitating the presurgical collection of blood from anemic patients for possible     self-transfusion during and after scheduled joint surgery and its effectiveness in reducing     surgery-related transfusion requirements. Epoetin alfa is a genetically engineered protein     that stimulates red blood cell production.   "
185868|NCT00278421|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,     such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.     It is not yet known which schedule of rituximab and combination chemotherapy is more     effective in treating non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and     combination chemotherapy to compare how well they work in treating patients with aggressive     B-cell non-Hodgkin's lymphoma.   "
185869|NCT00278434|"     RATIONALE: Chemoprevention is the use of certain drugs to keep tumors from forming, growing,     or coming back. Zoledronate may prevent the growth of cervical cancer by blocking blood flow     to cervical intraepithelial neoplasia cells. The use of zoledronate may keep cancer from     forming.      PURPOSE: This randomized is studying how well zoledronate works in treating patients with     cervical intraepithelial neoplasia 2/3 or 3.   "
185870|NCT00278447|"     The objective of this study is to test whether a chronic disease management (CDM) program for     substance abusers in primary care leads to improved alcohol and drug-related outcomes (such     as reduced consumption and health problems) and health care utilization patterns.   "
185871|NCT00278460|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel     works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.   "
185872|NCT00278473|"     This study will determine the effectiveness of group cognitive-behavioral therapy as compared     to a problem-solving social support group in treating problems of time management,     organization, and planning in adults with attention deficit hyperactivity disorder (ADHD).   "
185873|NCT00278486|"     ARRON is a disease believed to be due to immune cells, cells which normally protect the body,     but are now attacking the tissue in the retina and/or optic nerve. In addition, the disease     may affect the nerves in the ear or other parts of the body . The affected nerves fail to     respond, or respond only weakly, to stimuli causing numbing, tingling, pain, and progressive     muscle weakness. If the nerves to the ear are affected, reduced hearing or deafness may     result. The likelihood of progression of your disease is high. This study is designed to     examine whether treating patients with high dose cyclophosphamide and rabbit ATG (drugs which     reduce the function of the immune system) followed by return of previously collected blood     stem cells will stop the progression of ARRON syndrome. Stem cells are undeveloped cells that     have the capacity to grow into mature blood cells, which normally circulate in the blood     stream. The purpose of the cyclophosphamide and rabbit ATG is to destroy the cells in the     immune system which are thought to be causing this disease. The purpose of the stem cell     infusion is to restore the body's blood production, which will be severely impaired by the     high dose chemotherapy and to produce a normal immune system that will no longer attack the     body.   "
185874|NCT00269958|"     The purpose of this study is to evaluate the safety and effectiveness of two different dosing     schedules of epoetin alfa versus placebo for decreasing the need for blood transfusions and     preventing the occurrence of severe anemia during the period of time around total hip     replacement surgery. Epoetin alfa is a genetically engineered protein that stimulates red     blood cell production.   "
185875|NCT00269971|"     The purpose of this study is to determine an effective dose of epoetin alfa to be     administered prior to surgery, to decrease the need for blood transfusions during hip     replacement. Epoetin alfa is a genetically engineered protein that stimulates red blood cell     production.   "
185876|NCT00269984|"     The purpose of this study is to determine the safety and effectiveness of epoetin alfa versus     placebo, injected beneath the skin, in the treatment of patients with persistent anemia     caused by advanced cancer, with a below normal hematocrit of <= 37%. Epoetin alfa is a     genetically engineered protein that stimulates red blood cell production.   "
185877|NCT00269997|"     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus     placebo in the treatment of persistent anemia caused by advanced cancer and aggressive     cisplatin chemotherapy. Epoetin alfa is a genetically engineered protein that stimulates red     blood cell production.   "
185983|NCT00271388|"     The purpose of the current proposal is to pilot a new and potentially improved treatment for     neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the     vestibular nerves that lie directly below the mastoid bones.   "
185878|NCT00270010|"     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus     placebo for the treatment of anemia in AIDS (Acquired Immunodeficiency Syndrome) patients     with anemia that is a result of this disease and zidovudine (AZT) treatment. Epoetin alfa is     a genetically engineered protein that stimulates red blood cell production.   "
185879|NCT00270023|"     The purpose of this study is to determine the safety and effectiveness of epoetin alfa and     whether epoetin alfa will enable self-donation of blood during an 11-day period before     surgery (which is shorter than the conventional 3-week blood donation period before surgery)     in patients who are not anemic and who will be undergoing orthopedic, heart and blood vessel,     or breast reduction surgery. Epoetin alfa is a genetically engineered protein that stimulates     red blood cell production. Normovolemic hemodilution (NVHD, withdrawal of a patient's blood     immediately before surgery, immediate replacement of blood with an equal volume of fluid, and     return of the withdrawn blood after completion of surgery; a procedure which reduces the loss     of blood during surgery) will also be performed.   "
185880|NCT00270036|"     The purpose of this study is to determine the safety of epoetin alfa and to determine the     effectiveness of epoetin alfa in reducing the need for blood transfusions after major     orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red     blood cell production.   "
186015|NCT00271817|"     To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high     cholesterol.   "
185883|NCT00270075|"     The purpose of this study is to determine whether epoetin alfa will enable self-donation of     at least 4 units of blood during the 2-week period before surgery (which is a shorter period     of time than the conventional 3-week blood donation period before surgery) in patients who     are not anemic and who will be undergoing orthopedic or heart and blood vessel surgery.     Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.   "
185884|NCT00270088|"     The purpose of this study is to evaluate the safety of epoetin alfa and to determine whether     epoetin alfa will reduce the need for blood transfusions during the period of time around     major orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates     red blood cell production.   "
185885|NCT00270101|"     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus     placebo in reducing the transfusion requirements in anemic patients with multiple myeloma,     and to investigate the quality-of-life benefits associated with the use of epoetin alfa.     Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.   "
185886|NCT00270114|"     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa and to     determine whether epoetin alfa will facilitate self-donation of blood before surgery in     patients who have anemia, (as indicated by low hematocrit levels, the percent of red blood     cells in whole blood) and who will be undergoing orthopedic surgery. Epoetin alfa is a     genetically engineered protein that stimulates red blood cell production.   "
185887|NCT00270127|"     The purpose of this study is to evaluate the effectiveness of epoetin alfa versus placebo in     reducing or preventing the need for transfusions in anemic patients with non-myeloid cancer     on non-platinum chemotherapy, and to investigate quality-of-life benefits associated with the     use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red     blood cell production.   "
185888|NCT00270140|"     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa at     doses of 150, 300, or 600 units per kilogram of body weight versus placebo in facilitating     presurgical collection of blood for self-donation during surgery of the knee, hip or spine.     Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.   "
185889|NCT00270153|"     Chronic allograft nephropathy (CAN) is the leading cause of longterm renal transplant loss.     Angiotensin-II may play a role in the development and progression of CAN. Angiotensin     converting enzyme inhibitors (ACEI) comprise a drug class that inhibit the effects of     angiotensin-II. However these drugs have been reported to cause elevated potassium and     creatinine levels in some renal transplant patients. Yet, there are now several retrospective     reports of long term benefits of improved renal function and graft survival in renal     transplant recipients. There have been no reports of prospective randomized controlled trials     of ACEI in renal transplant patients in the early post transplant period.      The purpose of the present study is to assess the safety of enalapril, a drug in the ACEI     class, when started 1-3 month post transplant. This is a double-blinded, randomized control     trial of enalapril vs. placebo in new renal transplant patients with serum creatinine values     no higher than 2.5mg/dl and normal serum potassium levels. The study drug will be     administered for 6 months. Patients will be monitored in the renal transplant clinic every     1-4 weeks according to routine protocol. Clinical end-points will be occurence of potassium     >5.9mEQ/L or sustained increase in serum creatinine >50% from baseline.   "
185890|NCT00270166|"     The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus     placebo in reducing or preventing the need for transfusions in anemic patients with cancer     receiving chemotherapy, and to investigate possible quality-of-life benefits associated with     the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red     blood cell production.   "
185891|NCT00270179|"     The purpose of this study is to evaluate the whether epoetin alfa stimulates the bone marrow     to produce red blood cells and therefore increases a patient's ability to self-donate blood     prior to major surgery. Epoetin alfa is a genetically engineered protein that stimulates red     blood cell production.   "
185984|NCT00271401|"     The purpose of this study is to compare the effectiveness and safety of intracoronary     stenting with or without abciximab, an anti-platelet therapy, and conventional coronary     angioplasty with abciximab in patients undergoing percutaneous coronary intervention.   "
185892|NCT00270192|"     This randomized controlled trial addresses the impact of simple antenatal breastfeeding     educational interventions on breastfeeding rates and practice in a tertiary hospital setting.      Hypothesis: A single antenatal encounter, which includes breastfeeding educational material     and individual instruction with a lactation counselor, can improve the initiation, duration     and exclusivity of breastfeeding compared to routine antenatal care or the use of educational     material alone   "
185893|NCT00270205|"     LC002 is an experimental therapeutic vaccine designed to boost the immune response of people     infected with HIV. The purpose of this study was to determine the safety and tolerability of     and immune response to LC002 in HIV-1-infected adults who are currently receiving anti-HIV     treatment.   "
185894|NCT00270218|"     The purpose of this study is to determine the safety of and immune response to an adenoviral     vector HIV vaccine or a DNA HIV vaccine, each followed by an adenoviral vector HIV vaccine     boost, in HIV uninfected adults.   "
185895|NCT00270231|"     Despite preclinical evidence supporting the role of the endogenous opioid system in the     reinforcing effects of nicotine, the efficacy of the opioid antagonist naltrexone (NTX) as a     tobacco dependence treatment remains unresolved. Research is needed to identify those smokers     for whom NTX will have the strongest beneficial effects on smoking behavior.      The research bridges existing knowledge of genetic, pharmacologic, and behavioral responses     to nicotine, and translates this knowledge to treatment for tobacco dependence. The immediate     goal was to test whether genetic variation in the mu-opioid receptor gene predicts the     effects of naltrexone (NTX) on nicotine reinforcement.   "
185896|NCT00270244|"     This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus     treatment as usual (TAU) in improving the treatment of depressed adolescents in school-based     health clinics.   "
186054|NCT00278499|"     The purpose of this study is to collect data on the HIV strains currently circulating among     female sex workers (FSWs) and their clients. In addition, this study will identify potential     participants for future studies.   "
185897|NCT00270257|"     Drug abuse and HIV/AIDS are serious global health problems. Injection drug use is currently     the major mode of transmission of HIV in many countries. The purpose of this study is to     determine the effectiveness of drug and risk reduction counseling combined with either     substitution drug treatment with buprenorphine/naloxone (BUP/NX) or short-term detoxification     with BUP/NX in preventing HIV transmission among injection drug users. Participants will be     recruited for this study in China and Thailand.   "
185898|NCT00270270|"     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus     placebo in AIDS patients for the treatment of anemia that is a result of the disease or a     result of zidovudine (AZT) treatment for AIDS. Epoetin alfa is a genetically engineered     protein that stimulates red blood cell production.   "
185899|NCT00270283|"     The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa in AIDS     patients for the treatment of anemia that is a result of the disease and zidovudine (AZT)     treatment. Epoetin alfa is a genetically engineered protein that stimulates red blood cell     production.   "
185900|NCT00270296|"     Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child     transmission (MTCT) of HIV in developed countries. However, little is known of the     effectiveness of such regimens in developing countries, such as Botswana. This study will     determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and     zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV)     is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected     pregnant women in Botswana.   "
185901|NCT00270309|"     Objective To test the hypothesis that a nurse-led self-management programme is effective for     men with uncomplicated lower urinary tract symptoms. This will be achieved by comparing     symptom seveirty and the amount of drug therapy used to manage these symptoms in men who     attend a self-management programme, compared to those who do not.      Study design This study will use the format of a randomised controlled trial. 200 new     patients with uncomplicated LUTS will be randomised to either attend or not attend (standard     therapy) a self-management programme. The programme provides education, reassurance, prostate     cancer risk, advice on lifestyle modifications (e.g. fluids - type and amount), concurrent     medication re-scheduling and behavioural changes (double-voiding, strategies for dribbling,     and bladder re-training). These strategies are learnt through group discussion, problem     solving and goal setting.      All men start the study with a period of watchful waiting (monitoring symptoms only) and are     followed up for a total of 1 year. At each assessment (baseline, 3, 6, and 12 months) symptom     severity and the use of drug therapy to control symptoms will be compared between the two     groups. The only difference between them is that one group has attended a self-management     programme and the other has not.      Potential application of results Self-management focuses on patient involvement in health     care by involving them in the day-to-day control of their symptoms. If effective,     self-management may provide a long-term method of managing LUTS without using drug therapy,     thereby offering considerable health gain and financial savings.      The NHS Modernisation Agency wishes to develop the role of the nurse specialist to manage     some patients independently of doctors. Nurse-led LUTS assessment clinics are now well     established, perhaps nurses managing these patients with self-management interventions may     become part of standard therapy.   "
185902|NCT00270322|"     The study purpose is to compare the effectiveness of different methods for post-operative     pain treatment after total knee replacement.   "
185903|NCT00270335|"     An accurate dosage of anesthetics during surgery is important. Usually this is achieved     through close observation of the patient, but a new monitor (CSM-monitor) can measure the     level of anesthesia more closely.      In obese patients dosage of drugs is difficult due to the change in body composition. The     CSM-monitor may provide a more accurate dosage of propofol (an anesthetic agent) during     surgery, and as a consequence of that, also reduce the postoperative need for analgesics.      Main objective: To optimise propofol dosing in obese patients undergoing hysterectomy.      Main hypothesis: Monitoring the depth of anesthesia using the CSM-monitor reduces time to     opening eyes in obese patients after hysterectomy in propofol anesthesia.      Secondary hypotheses: CSM-monitoring reduce propofol dose in obese patients undergoing     hysterectomy. Patients with a high CSM-level during hysterectomy have higher postoperative     consumption of analgesics. Supplementary, an algorithm for the dose of propofol that most     frequently results in a CSM-level between 40 and 60 is calculated.   "
185904|NCT00270348|"     The primary objective is to determine if CIC 50 mg/day or 200 mg/day (ex-valve) administered     once daily in the morning is non-inferior to placebo with respect to growth velocity in     children with mild persistent asthma following a 12-month treatment period      The secondary objective is to investigate changes in growth in terms of bone age (wrist     X-ray), and maintenance of asthma control and safety with ciclesonide   "
186036|NCT00272103|"     This study aims to determine the efficacy and optimal dose of the prokinetic itopride for the     treatment of patients with functional dyspepsia.      The study will test in patients with functional dyspepsia the hypothesis that itopride is     superior to placebo with regard to the improvement of symptoms.   "
185905|NCT00270361|"     The purpose of this study is to assess the safety and tolerability of two doses of nesiritide     (a recombinant form of the natural human peptide normally secreted by the heart in response     to heart failure) when administered serially as a treatment to outpatients with worsening     congestive heart failure (decompensated CHF) who are receiving their usual cardiac     medications and are at high risk for hospitalization.   "
185906|NCT00270374|"     The purpose of this study is to compare the hemodynamic (blood flow) and clinical effects of     the study drug, Natrecor (nesiritide, a recombinant form of the natural human peptide     normally secreted by the heart in response to heart failure) to those of intravenous     nitroglycerin or placebo, when added to the standard care therapy that is usually     administered in the treatment of patients with worsening congestive heart failure.   "
185907|NCT00270387|"     The purpose of this pilot study is to compare the clinical effects, safety profile, and     economic impact of standard therapy plus NatrecorÂ® (nesiritide, a recombinant form of the     natural human peptide normally secreted by the heart in response to heart failure) to     standard therapy plus placebo in patients who present to the Emergency Department with     worsening congestive heart failure (CHF) and are treated in the Emergency Department     /Observation Unit.   "
185908|NCT00270400|"     The purpose of this study is to compare the effects on heart rate and ventricular arrhythmias     (irregular heart beats) of two doses of NatrecorÂ® (a recombinant form of the natural human     peptide normally secreted by the heart in response to heart failure) versus dobutamine,     during the first 24 hours of treatment of decompensated congestive heart failure (CHF).   "
186144|NCT00283582|"     Intensive chemotherapy is often associated with low platelet counts often requiring platelet     transfusions to maintain platelet counts. In previous clinical studies administration of     rhTPO has been demonstrated to increase platelet counts.   "
185909|NCT00270413|"     This study tests the hypothesis that SU11248 can delay tumor progression after tumor mass     reduction by taxanes. This is a dual-arm open-label randomized multicenter phase II clinical     trial with 2:1 randomization evaluating the efficacy of SU11248 versus nil in patients with     metastatic breast cancer after objective response to taxane chemotherapy. Patients randomized     to the placebo arm (Arm B) will be offered the opportunity to receive open-label SU011248     treatment upon development of Response Evaluation Criteria in Solid Tumors (RECIST)-defined     disease progression.   "
185910|NCT00270426|"     The purpose of this study is to further determine whether benazepril, could safely slow the     progression of renal dysfunction in non-diabetic patients with advanced renal insufficiency.   "
185911|NCT00270439|"     The purpose of this study is to determine whether laparoscopic removal of the omentum (thin     layer of fat inside the abdomen) will significantly improve insulin resistance in patients     with non-insulin dependent type 2 diabetes mellitus.   "
185912|NCT00270452|"     This study will test whether certain patients with myelodysplastic syndrome (MDS), acute     myeloid leukemia (AML) or chronic myeloid leukemia (CML) can safely be vaccinated with two     peptide vaccines derived from proteins called proteinase 3 (PR1) and Wilm's tumor-1 (WT1).     These proteins are produced in large amounts by cells of MDS, AML and CML patients. The     peptides are combined with an adjuvant called Montanide to make the vaccines, and the     vaccines are given with GM-CSF (sargramostim). Both Montanide and sargramostim help the     immune system respond to the vaccines. The vaccines then activate the immune system to make     specialized cells that search out and kill the MDS, AML and CML cells containing the two     proteins.      Patients with MDS, AML or CML who are 18 years of age or older may be eligible for this     study. Candidates are screened with a medical history and physical examination, blood tests,     chest x-ray, and bone marrow aspirate and biopsy. For the bone marrow biopsy, the area of the     hip is anesthetized and a special needle is used to draw marrow from the hipbone.      Participants receive an injection (shot) of each peptide vaccine into deep tissue of the     upper arm, upper leg, or the abdomen and two separate shots of sargramostim in the same area     as the vaccine shots. Patients' vital signs (heart rate, breathing rate, temperature, blood     pressure) are measured before and after they receive the vaccines and they are watched for 2     hours after the shots for possible side effects, such as chills, pain at the injection site,     stomach upset, allergic reaction, low blood counts, and infection.      Patients return to the clinic 1, 2, 3 and 4 weeks after receiving the vaccines for a brief     physical evaluation and blood tests. A chest x-ray is also done at the 4-week visit. Patients     may receive whole blood or platelet transfusions if needed to treat the MDS, growth factors     (filgrastim, erythropoietin, or others) if needed, and medications to treat any infections     that may develop.   "
185913|NCT00270465|"     Study Design: This is a Phase I, randomized, placebo-controlled, double-blinded study to     examine safety, tolerability and immune response of a prime-boost vaccination regimen for     treatment of HIV infection. The vaccination schedule consists of three injections of a     multiclade HIV plasmid DNA vaccine followed by one injection of a multiclade recombinant     adenoviral vector vaccine (rAd), in HIV-infected adults. The hypothesis is that this     vaccination regimen will be safe and elicit an immune response in HIV-infected subjects. The     primary objectives are related to evaluating the safety and tolerability of the vaccination     regimen and assessing the effect of vaccination on humoral and cellular immune responses to     vaccine-specific HIV antigens.      Product Description: VRC-HIVDNA016-00-VP is composed of 6 closed, circular DNA plasmids that     are each 16.67% (by weight) of the vaccine. Each of the 6 plasmids in this vaccine expresses     a single gene product. Plasmids VRC 4401, VRC 4409 and VRC 4404 are designed to express clade     B HIV-1 Gag, Pol and Nef, respectively. VRC 5736, VRC 5737, and VRC 5738 are designed to     express HIV-1 Env glycoprotein from clade A, clade B, and clade C, respectively. Each DNA     vaccination will be 1 mL of vaccine administered intramuscularly (IM) using the Biojector     2000 Needle-Free Injection Management System. Phosphate buffered saline (PBS) will be used as     the placebo for the DNA vaccine.      VRC-HIVADV014-00-VP (rAd) is a recombinant product composed of 4 adenoviral vectors (Ad) (in     a 3:1:1:1 ratio) that encode the HIV-1 Gag/Pol polyprotein from clade B and HIV-1 Env     glycoproteins from clades A, B, and C, respectively. Injections of 10(10) PU will be     administered IM by needle and syringe. The final formulation buffer (FFB) will be used as the     placebo for the rAd vaccine.      Subjects: HIV-infected adult volunteers (18-50 years old) on stable highly active     antiretroviral therapy (HAART) therapy who have a CD4+ cell count greater than 350 cells/mm3     and have had a viral load (VL) less than 400 copies/mL for at least six months and a viral     load of less than 50 copies/mL within 4 weeks prior to enrollment.      Study Plan: Fifteen volunteers will be enrolled and randomized in a 2:1 ratio to     vaccine:control (10 DNA prime with rAd boost:5 PBS with FFB placebo). A Data and Safety     Monitoring Board (DSMB) will review the study every 6 months. Subjects will be evaluated for     safety and immunogenicity for 48 weeks, which is 24 weeks after the target date for the     booster vaccination.      Study Duration: Subjects will be followed for 48 weeks after enrollment into the study.   "
185929|NCT00270686|"     Background:      - Heritable disorders of connective tissue are genetic conditions that can affect the skin     and other parts of the body. They are related to mutations in genes that are responsible for     building tissues. The symptoms differ among disorders. Researchers want to study which genes     may be responsible for different disorders. They will be performing a long-term (up to 10     years) study and a study that requires a single visit. These studies will look at how these     disorders affect the body and what genes may cause these conditions.      Objectives:      - To perform one-time and long-term studies of people who have heritable disorders of     connective tissue.      Eligibility:      - Individuals at least 2 years of age who have or may have a heritable disorder of connective     tissue.      Design:        -  Participants will be screened with a physical exam, medical history, and blood samples.        -  Participants will be on one of two parts of this study. The longitudinal arm will          require long-term study over about 10 years. The mutational analysis arm will involve a          single visit.        -  Longitudinal arm participants must be at least 12 years of age. They will have study          visits at regular intervals for up to 10 years. The tests given at these visits may          include all or some of the following:        -  Blood, saliva, urine, and skin samples        -  Heart and lung function tests        -  Magnetic resonance imaging scans of the neck, chest, spine, and abdomen        -  Other imaging studies such as x-rays, bone density scans, and ultrasounds        -  Questionnaires about sleep, pain, and quality of life        -  Photographs of affected areas.        -  Mutational analysis arm participants will have a single study visit. They will provide          blood and saliva samples. They will provide tissue from a skin biopsy. They will also          let the researchers take photos of any affected body parts. They will complete          questionnaires about sleep, pain, and quality of life.   "
185930|NCT00270699|"     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and     subtropical regions of the world. The purpose of this study is to test the safety of and     immune response to a new dengue virus vaccine in healthy adults.   "
185914|NCT00270478|"     This study will examine the use of hydroxyurea and erythropoietin for treating sickle cell     disease in patients who also have kidney disease or pulmonary hypertension (high blood     pressure in the lungs). Hydroxyurea increases production of fetal hemoglobin in the red blood     cells of patients with sickle cell disease, reducing the amount of sickle cells that cause     pain and other complications requiring hospitalizations. However, hydroxyurea treatment has     limitations: patients with sickle cell disease who have developed kidney disease may not be     able to get the full benefit of the medicine, and hydroxyurea alone may not be able to treat     life-threatening complications such as pulmonary hypertension or stroke. This study will     determine which of two dosing schedules of hydroxyurea and erythropoietin is more effective     for treating patients with sickle cell disease who also have kidney disease or pulmonary     hypertension, and will examine whether the two drugs can lower blood pressure in the lungs.      Patients 18 years of age and older with sickle cell anemia and kidney disease or pulmonary     hypertension, or both, may be eligible for this study. Candidates are screened with a medical     history, physical examination, blood tests, a 6-minute walk test (test to see how far the     subject can walk in 6 minutes), and echocardiogram (ultrasound of the heart to measure blood     pressure in the lungs).      Participants undergo the following tests and procedures:      Stabilization Phase: Patients take 2 hydroxyurea tablets a day until their fetal hemoglobin     levels stabilize, usually over 2 to 4 months. They have blood tests every 2 weeks to monitor     hemoglobin and fetal hemoglobin levels. At some time during this period, they undergo a test     to measure kidney function, in which they are injected with an iodine-containing dye and wear     a small pump for 1 day that injects a small amount of dye under the skin over 24 hours. They     come to the clinic for 2 or 3 blood tests collected over 4 hours.      Sequence I (Standard): When the fetal hemoglobin levels have been stable for 2 months,     patients have a repeat echocardiogram and 6-minute walk test. Erythropoietin is then added to     the hydroxyurea regimen. It is given 3 days a week, as an injection under the skin, along     with iron supplements. Patients have blood tests and blood pressure measurements every week     or every other week. Patients with pulmonary hypertension have another echocardiogram and     6-minute walk test once the hemoglobin level is stable.      Sequence II (Cycled): When hemoglobin levels have stabilized with hydroxyurea once a day and     erythropoietin 3 times a week, the hydroxyurea is adjusted so that the amount taken in 7 days     is cycled over 4 days, and the erythropoietin is cycled over 3 days, with the dose     increased twice, every 3 to 4 weeks. Blood pressure and hemoglobin are monitored once or     twice a month. Patients with pulmonary hypertension have another echocardiogram and 6-minute     walk test once the hemoglobin level is stable.      Patients who develop complications while taking the drugs have their treatment regimens     adjusted as needed.   "
185915|NCT00270491|"     Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with     weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel -     capecitabine, in patients with metastatic breast cancer.   "
185916|NCT00270504|"     The purpose of this study is to evaluate if the placement of a temporary urethral stent for     up to 12 months, following dilation or internal urethrotomy (cutting open), results in a     higher rate of urethral patency during the first year of follow-up when compared to the     control group that does not receive a stent.   "
185917|NCT00270517|"     This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral     antibiotic in the treatment of community acquired pneumonia   "
185918|NCT00270530|"     Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia     and its serious impact on both maternal and infant survival. Intermittent presumptive     treatment with sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing     the risk of malaria in pregnancy. However, based on a study done in western Kenya,     HIV-infected pregnant women may need more frequent dosing of SP, i.e., on a monthly basis     rather than the standard 2-dose regimen given during the second and third trimesters, as HIV     appears to reduce the effectiveness of the SP drug combination. The goal of this study was to     evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly SP     dosing schedule in HIV-positive women.   "
185919|NCT00270543|"     The primary endpoint of this phase II trial is the objective tumor response rate. The     secondary endpoints include treatment-related toxicity, the clinical benefit response defined     by the change in performance status and body weight, the change in quality of life,     progression free survival and overall survival. Simon's optimal two-stage design will be used     to determine the patient number.   "
185920|NCT00270556|"     This 48 week study is designed to compare the substitution of the thymidine analogues     zidovudine (ZDV) or stavudine (D4T) with either tenofovir DF or abacavir, in patients treated     with highly active antiretroviral therapy (HAART), and show improved outcomes on total limb     fat mass, improved body shape by dual energy x-ray absorptiometry (DEXA) and computed     tomography (CT) scans and improved cholesterol and tryglicerides.   "
185921|NCT00270569|"     The primary endpoint of this phase II trial is the objective response rate of the stage I     (low-dose) regimen. The secondary endpoints include treatment-related toxicity, the change in     quality of life, progression free survival and overall survival. Simon's optimal two-stage     design will be used to determine the patient number.   "
185922|NCT00270582|"     Primary to evaluate the 1-year treatment failure rate of two sequential chemotherapy     regimens:        1. weekly docetaxel plus cisplatin followed by gemcitabine and        2. gemcitabine plus cisplatin followed by weekly docetaxel. Study design:Prospective,          multi-center, open-labelled, randomized phase II study.   "
185923|NCT00270608|"     The purpose of this study is to evaluate the effect of vigorous physical activity versus     extremely sedentary life style during young age on the bone mineral density and general     health in later life.   "
185924|NCT00270621|"     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the     effectiveness of the Strongest Families distance intervention compared to usual or standard     care that is typically provided to children with mild to moderate Enuresis diagnoses. This is     a single-centre trial based at the IWK Health Centre. The primary outcome is change in     diagnosis.   "
185925|NCT00270634|"     This study will see if voclosporin is safe and effective in preventing kidney transplant     rejection.   "
185926|NCT00270647|"     The use of vitamin E, vitamin C, beta carotene, and/or multivitamins may keep cancer,     cardiovascular disease, eye diseases, or cognitive decline from occurring. This randomized     clinical trial studied vitamin E, vitamin C, beta carotene, and/or multivitamins to see how     well they work compared with placebos in preventing cancer, cardiovascular disease, eye     disease, and cognitive decline in male doctors aged 50 years and older.   "
185927|NCT00270660|"     The purpose of the study is to study the clinicopathologic behaviour of the 3 dangerous types     of chronic otitis media that are prone for complications. In which type are the complications     more common? Which type gives rise to more hearing loss? How does the disease process in the     3 types evolve? should the 3 types of otitis media be managed differently?   "
185928|NCT00270673|"     Blood lactate levels have long been related to tissue hypoxia, a severe condition in     critically ill patients associated with the development of organ system failure and     subsequent death. Increased blood lactate levels and failure to normalize blood lactate     levels during treatment have been associated with increased morbidity and mortality. However,     evidence of improved clinical outcome of lactate-directed therapy is limited and difference     in the use of blood lactate monitoring in the intensive care unit exists between hospitals.     This warrants a study on the efficacy of early blood lactate-directed therapy. In this study     the efficacy of 8 hours of early lactate-directed therapy (therapy aimed at resolving tissue     hypoxia that is guided by serial blood lactate levels) will be compared with 8 hours of     control group therapy (without lactate measurement).   "
185931|NCT00270712|"     The causes of deterioration of transplanted kidney function are poorly understood. The     purpose of this study is to determine the disease processes that cause transplanted kidney     dysfunction and loss in patients who received a kidney either recently or over a year prior     to entering this study. This study will also identify specific characteristics in kidney     transplant recipients that predict whether a kidney transplant will be successful.   "
185932|NCT00270725|"     The purpose of this study is to determine the impact of anti-HIV treatment on the work     attendance of employed people in South Africa. The study will enroll participants from a     large manufacturing and distribution firm in South Africa.   "
185944|NCT00270881|"     The primary purpose of this study is to evaluate the safety and efficacy of cord blood     transplantation for adult patients with hematologic malignancies including refractory acute     leukemia. The transplant procedure was determined in detail according to the previously     published report showing a high survival, so that the investigators could expect a similar     result.   "
185945|NCT00270894|"     The purpose of this study is to evaluate the effectiveness and tolerability of the     combination of the following medications given every two weeks in HER2 positive breast cancer     patients:        -  trastuzumab (Herceptin)        -  epirubicin (Ellence)        -  cyclophosphamide (Cytoxan)        -  docetaxel (Taxotere)   "
186271|NCT00275210|"     To evaluate the FOLFOX regimen versus LV5FU2 in the adjuvant treatment of stage II and III     colon cancer.      Primary objective: Disease Free Survival (DFS) Secondary objective: Overall Survival (OS),     safety (including long term toxicity)   "
185933|NCT00270738|"     Urinary incontinence (UI) is the complaint of any involuntary leakage of urine. Stress     urinary incontinence (SUI) is the complaint of involuntary leakage on effort or exertion, or     on sneezing or coughing. The prevalence of female UI is greater than that of male, and the     commonest type is SUI. UI has significant impact on the quality of life including physical,     mental and social issues. SUI may also lead to withdraw from regular physical exercise and     fitness activities that important in the prevention of osteoporosis, coronary heart disease,     and so on. The cause of SUI is related to the impairment of pelvic floor muscles (PFM). So     far, the effects of intensive pelvic floor muscle training for female SUI were proved in many     randomized controlled trials. However, training of accurate contraction of PFM depends on     vaginal palpation. The willingness to seek for medical help may be reduced due to being     embarrassed with vaginal palpation. Sapsford proposed a concept to treat SUI via transversus     abdominis (TrA) that does not need to palpate the vagina. Maybe the new intervention can     promote the willingness to seek medical help. However, to date there is no randomized     controlled trial comparing the effect of indirect training of the PFM via TrA with either     untreated control or other intervention. Therefore, there are two purposes in this study, to     compare the effect of indirect training of PFM via TrA with control group and to compare the     effect of indirect training of PFM via TrA with PFMT for female SUI.   "
185934|NCT00270751|"     Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate,     especially regarding the method of pleurodesis. Previous studies have shown that     thoracoscopic apical pleurectomy is a reliable method with a very low incidence of     recurrence. However, this procedure is more technical demanding and time consuming through     thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary     function and a higher risk of perioperative complication such as hemothorax. In our previous     studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is     an easy and convinent method of pleurodesis which decreases the rate of recurrence without     affecting pulmonary function. In this study, we hypothesized that pleural abrasion with     minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax     recurrence while the short-term and long-term complications are less.   "
185935|NCT00270764|"     The purpose of this study is to determine the social and economic outcomes of anti-HIV     treatment in South African adults, with data collected from interviews, detailed     questionnaires, and patients' medical records.   "
185936|NCT00270777|"     A study to increase the safety of polyvalent antivenom involving 1000 patients in three     centres: low dose adrenaline, promethazine, & hydrocortisone (alone and in combination) to     prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double     blind, placebo-controlled trial.   "
185937|NCT00270790|"     Purpose of this study:      There is some evidence that the best treatment for head and neck cancer involves a     combination of radiation therapy and chemotherapy. Radiation therapy is a form of cancer     treatment using high energy x-rays. Chemotherapy is a form of cancer treatment that uses     special medications. This study uses two chemotherapy drugs (Taxol and Carboplatin), which     are FDA approved for treating head and neck cancers. This treatment combination has been     associated with difficulty, pain, or a burning sensation upon swallowing (called     esophagitis), and decrease in blood cells (cells in the blood which fight against infection).     The purpose of this study is to investigate whether the addition of another drug, Amifostine,     can reduce the side effects of current combination treatment (radiation and chemotherapy     which is standard of care). The addition of Amifostine is the investigational part of the     study. The research study is also looking at the side effects of Amifostine and cancer's     growth response to this combination treatment.   "
185938|NCT00270803|"     This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor     coordination and brain metabolic activity in regular users of marijuana. Subjects were tested     twice, after smoking cigarettes with marijuana and after smoking cigarettes without     marijuana.On both occasions they performed on a virtual reality maze task. They were     afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG).   "
185939|NCT00270816|"     The therapy with Interferon-ß-1b reduces the inflammatory component of multiple sclerosis     with positive effects on the disease course. The 8 MUI dose at alternate days is kept     constant for years. About 1/3 of patients suspend treatment by three years due to side     effects or suspected or accepted ineffectiveness. The main objective of the study is to     verify the safety and effectiveness of a cyclical administration (a month of suspension after     two of treatment) from the beginning of treatment. There is the possibility that a scheme     envisaging therapy free intervals can reduce the onset of negative feedbacks (antagonising     the drug therapeutic effect) compared to the standard administration protocol. This might     also result in an increase of the drug effectiveness and/or in a longer duration of     effectiveness itself. Finally, cyclical administration allows patients to spend actual     periods of therapeutic vacation, with positive psychological effects.   "
185940|NCT00270829|"     The impact of nesiritide in CHF is unclear, but it is possible that systemic vasodilation     leads to adverse consequences even if the direct renal effects are positive. Therefore, this     study will look at the effects of direct intrarenal administration of nesiritide on GFR and     RPF.   "
185941|NCT00270842|"     The purpose of this study is to find out if participation in one of the study groups:     functional balance training, Tai Chi, or education, results in better outcomes overall. The     outcomes that we are primarily interested in are related to walking ability and balance.   "
186049|NCT00272285|"     The purpose of this study is to compare the efficacy and safety of ramosetron plus     dexamethasone injection with granisetron plus dexamethasone injection for the prevention of     chemotherapy-induced vomiting and nausea.   "
185942|NCT00270855|"     The purpose of this proposal is to evaluate and compare the health benefits of using upper     extremity exercise versus functional electrical stimulation for lower extremity exercise. It     is our hypothesis that both Functional Electrical Stimulation Leg Cycle Ergometry (FES LCE)     exercise and voluntary Arm Crank Ergometry (ACE) upper extremity exercise will increase whole     body energy expenditure, thereby increasing muscle mass, insulin sensitivity, glucose     effectiveness and improving lipid profiles in adults with paraplegia.   "
185943|NCT00270868|"     The purpose of this study is to determine if the double guide wire technique is more     effective than the conventional method in those cases of difficult selective biliary     cannulation in the ERCP procedures.   "
185946|NCT00270907|"     The goal of this phase I clinical study is to find the highest safe dose of gemcitabine and     CT-2103 that can be given in combination for the treatment of metastatic breast cancer. The     safety and effectiveness of this combination will also be studied. This clinical trial will     be offered to patients who are being considered for treatment with gemcitabine. Research lab     samples and research biopsies will not be requested as part of this study.   "
185947|NCT00270920|"     This is a randomised controlled trial to compare antenatal preparation and postnatal     counseling strategies for improving breastfeeding rates.      The objectives are:        1. to study the effect of a standard two-encounter postnatal lactation counseling protocol          on the initiation and maintenance of exclusive breastfeediing in mothers        2. to compare the effect of a standard two-encounter postnatal lactation counseling          protocol with a single-encounter antenatal breastfeeding education protocol on the          initiation and maintenance of exclusive breastfeeding in mothers.   "
185948|NCT00270933|"     The purpose of this registry is to collect information on the health status of patients     receiving Marquis/Maximo VR Implantable Cardiac Defibrillators (ICDs), how the devices are     being programmed and how this correlates to clinical patient outcome.   "
185949|NCT00270946|"     This study was designed to evaluate the clinical benefits and safety of OrCel in the     treatment of venous ulcers. OrCel and standard care were compared to standard care alone.     Standard care consisted of currently accepted compression therapy.      Patients were treated for 12 weeks. Patients with healed ulcers were followed for an     additional 12 weeks to assess durability of the healed wound.   "
185950|NCT00270959|"     This study will evaluate the effectiveness of patient-centered collaborative care that     combines behavioral therapy and drug therapy as compared to usual care in reducing symptoms     of post-traumatic stress disorder in people who have survived a traumatic injury.   "
185951|NCT00270972|"     This study was designed to confirm the clinical benefits and safety of OrCel in the treatment     of venous ulcers. OrCel and standard care are compared to standard care alone. Standard care     consists of currently accepted compression therapy.      Patients are treated for 12 weeks. Patients with healed ulcers are followed for an additional     12 weeks to assess durability of the healed wound.   "
185952|NCT00270985|"     Study Hypothesis:      Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c)     levels in adults with pre-diabetes.      Lay Summary:      Persons developing type 2 diabetes mellitus (T2DM) will typically first have a condition     called pre-diabetes. Lifestyle is a major factor that determines whether pre-diabetes becomes     full T2DM. Lifestyle includes dietary habits and physical activity. Many people develop T2DM     because of poor dietary habits and a sedentary lifestyle. Moreover, eating a high-fat,     high-sugar diet can damage the blood vessels and increase the risk of strokes and heart     attacks. A person's diet may produce substances in the blood that can interfere with the     production of insulin in the pancreas. Sometimes, these changes in the insulin producing     cells are serious and can eventually interfere with how the cells in the body use blood     sugar, which causes T2DM. Techniques are available to measure circulating substances in the     blood of persons with pre-diabetes that may be associated with the development of T2DM.     Laboratory research has shown that almonds contain high levels of important compounds that     may influence the onset of heart disease and T2DM. A meal plan that includes almonds daily     will be given to half of the study participants and the other participants will be given a     meal plan that is nut-free. Because of the potential to delay the onset of heart disease     and T2DM in some persons with pre-diabetes, this 16-week study will collect and analyze blood     samples for changes that may make the person with pre-diabetes more likely to develop heart     disease and T2DM. Blood samples will be collected at weeks 0, 8 and 16 to measure compounds     that may be influenced by consuming almonds daily. This study will also attempt to understand     other possible causes of heart disease and T2DM in persons with pre-diabetes; particularly     those that might be related to body weight and body composition. Body composition techniques     using very small amounts of electrical current are available to study body fat. Body weight,     waist and hip measurements, blood pressure and body composition testing will be performed at     the start of the study and every 4 weeks during the study. Lastly, these other possible     causes of heart disease and T2DM will be investigated to look at relationships with the     substances in the blood.   "
185953|NCT00270998|"     Stress urinary incontinence is the uncontrollable leakage of urine with physical effort or     stress, such as coughing, sneezing, or exercise. Treatment for stress incontinence can be     surgical or non-surgical. Different non-surgical treatments include pelvic muscle exercises     and pessary use. Pelvic muscle exercises (often known as Kegel exercises) train and     strengthen the pelvic muscles and improve incontinence. A pessary is a medical device that     fits inside the vagina to give the urethra and bladder extra support and prevent or reduce     urinary incontinence. Exercises and pessary use can help women with stress incontinence but     it is not known which treatment is better, or if a combination of the two treatments at the     same time is best. This study will determine whether pelvic muscle training and exercises,     pessary use, or a combination of both exercises and pessary is most effective at improving     incontinence in women. The study's primary hypothesis is that pessary use is more effective     than pelvic muscle exercises after 3 months of treatment.   "
185970|NCT00271219|"     Children born to women who abuse drugs have a high risk of being born with birth defects and     developmental problems. Methadone is a drug that is commonly used for treating opioid     dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a     newborn because of the prenatal exposure. The purpose of this study is to evaluate the     effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal     symptoms in children born to opioid-dependent women.   "
186050|NCT00272311|"     The purpose of the study is to test higher versus lower doses of aspirin on markers of     atherosclerosis in patients at risk of a first heart attack.   "
185954|NCT00271011|"     Colorectal cancer (CRC) is one of the more common cancers in the United States with over     145,000 new cases expected in 2005. Surgery is the main treatment for CRC. However for some     who relapse after surgery, or are unable to have surgery, chemotherapy is the primary     treatment for this more advanced CRC. Some chemotherapy drugs are given to the patient by     themselves, but many are given in combination with other chemotherapy treatment drugs and     they seem to work better together than by themselves. This study will investigate the     effectiveness of the combination of three chemotherapy drugs in patients who have been     previously treated for their CRC and it has returned. This study will also evaluate any rash     that is associated with the drug Cetuximab. The three therapy drugs are Mitomycin C,     Irinotecan, and Cetuximab.   "
185955|NCT00271024|"     The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to     compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard     smoking cessation treatment with nicotine patch and counseling.      Hypotheses:        1. Naltrexone will improve smoking cessation quit rates, as measured at the end of active          treatment (3 months) and during long term follow up (1 year).        2. Weight and smoking-related variables (i.e., less weight gain, as well as reduced craving          and withdrawal) will be important factors by which naltrexone improves smoking cessation          outcome.        3. These effects are predicted to be stronger in women compared to men.   "
185956|NCT00271037|"     Pelvic organ prolapse occurs when the pelvic organs (e.g., the uterus or bladder) fall or     slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. Some types     of surgery try to restore the normal anatomy and function of the vagina (i.e., reconstructive     surgery). Other surgery repairs the prolapse by essentially closing the vagina (e.g.,     colpocleisis or colpectomy), thereby leaving a woman unable to have vaginal intercourse in     the future. The use of colpocleisis has not been well-studied. The current literature is     lacking sufficient studies of colpocleisis to fully understand its risks and benefits for     women considering surgery for prolapse. Traditionally, colpocleisis has been restricted to     elderly women thought to be poor medical risks for prolonged reconstructive surgery. This     study will describe the postoperative course of women who undergo colpocleisis, with     particular attention to the persistence or recurrence of urinary incontinence and patient     satisfaction after the colpocleisis prolapse surgery.   "
185957|NCT00271050|"     The purpose of the research study is to learn whether external beam radiation can be used as     a safe and effective treatment for patients with bulky (≥ 5cm) sites of non-Hodgkin's     lymphoma prior to treatment with 90Y-ibritumomab tiuxetan (Zevalin).   "
185958|NCT00271063|"     This is a Phase I/II multi-center, open label, dose escalation study to identify the maximum     tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin     in patients with refractory or relapsed acute lymphocytic leukemia.   "
185959|NCT00271076|"     To assess the safety and feasibility of Volcano Corp Eagle Eye Gold Catheter system to     correlate the presence and characteristic of carotid artery atherosclerotic disease with     anatomic and histologic analysis.   "
185960|NCT00271089|"     Fanconi anemia (FA) is a disease that affects an individual's bone marrow. It is caused by a     defective gene in the CD34+ cells, which are responsible for producing various types of blood     cells. Individuals with FA may experience fatigue, bleeding, and increased infections. The     purpose of this study is to collect and purify blood cells from individuals with FA and store     them for future therapeutic use.   "
185961|NCT00271102|"     The purpose of this study is to determine whether vaginal repair or abdominal repair is the     procedure of choice for the surgical management of a prolapsed bladder.   "
185962|NCT00271115|"     The primary objective is to determine if kangaroo holding in the first week after birth     influences the stress levels of mothers who have delivered their infants prematurely and who     require admission to the Special Care Nursery (SCN).      Hypothesis: There will be a decrease in maternal stress levels as perceived by mothers and as     reflected in their blood pressures and heart rates after kangaroo holding their premature     infants in the SCN.   "
185963|NCT00271128|"     The proposed study intends to evaluate the impact of the NT-proBNP assay on the diagnosis of     heart failure in patients with dyspnea of unknown etiology presenting to the emergency room     and admitted to the medical wards.   "
185964|NCT00271141|"     The proposed work is based on the detection of a novel molecule for sensitivity to oxidative     stress in humans in venous blood   "
185965|NCT00271154|"     Heart failure is a progressive disease that decreases the pumping action of the heart. This     may cause a backup of fluid in the heart and may result in heart beat changes. When there are     changes in the heart beat sometimes an implantable heart device is used to control the rate     and rhythm of the heart beat. The purpose of the REVERSE clinical trial is to determine     whether pacing in both the left and right ventricles using Cardiac Resynchronization Therapy     (CRT) can help slow the progression of heart failure in people who have mild or previous     symptoms and poor heart pumping function. This kind of therapy has previously been shown to     reduce symptoms and improve exercise capacity in people with more advanced forms of heart     failure.   "
185966|NCT00271167|"     The purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-[ADP     ribose] polymerase) inhibitor, in patients undergoing heart surgery. The study also measures     whether INO-1001 reduces the side effects caused by heart-lung bypass machines.   "
185967|NCT00271180|"     The main purpose of the Product Performance Report (formerly referred to as System Longevity     Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm     products by analyzing product survival probabilities.   "
185968|NCT00271193|"     The study will test whether adding brief counseling visits with an ancillary health care     provider (a nurse or nursing assistant) will induce additional weight loss, as compared with     quarterly physician visits alone. All visits will take place at the site of usual patient     care (i.e., the primary care clinic).   "
185969|NCT00271206|"     Past research on nicotine addiction has shown that changes in estradiol and progesterone     hormone levels during menstruation may cause women to respond differently than men to     nicotine. The purpose of this study is to examine the effects of progesterone on smoking     behavior, nicotine withdrawal symptoms, and the reinforcing effects of smoking in men and     women addicted to nicotine.   "
185971|NCT00271232|"     People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating,     may be in need of an electronic device called an implantable cardioverter defibrillator     (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it     sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If     the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to     return the heart to its normal rhythm.      The InSync III Marquis device can change the timing of when the left and right ventricles of     the heart are paced to beat. This is called V to V timing. V to V timing may further     improve the pumping function of the heart. The purpose of this study is to determine whether     or not this V to V timing feature of the InSync III Marquis system is safe and effective.   "
185972|NCT00271245|"     The purpose of this study is to determine whether patients with liver cirrhosis can improve     their selenium nutritional status by taking supplemental selenium.   "
185973|NCT00271258|"     - Main objective: To evaluate the clinical and physiological tolerance of sodium divalproate     in manic, mixed or hypomanic episodes of bipolar disorder in adolescents treated for 6     months.      - Secondary objective: To evaluate the efficacy of sodium divalproate in improving manic,     mixed or hypomanic symptoms.   "
185974|NCT00271271|"     Primary:      ·To evaluate the activity of the combination of gemcitabine, oxaliplatin and vinorelbine as     first line treatment in patients with non-small cell bronchopulmonary cancer      Secondary:      ·To evaluate the toxicity of the combination   "
185975|NCT00271284|"     ·Main objective: To compare the variability of fasting capillary blood glucose concentration,     observed with insulin glargine combined with insulin glulisine and with insulin detemir     combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study.      ·Secondary objectives:      Efficacy:        -  To compare the variability of blood glucose concentration before the evening meal,          observed with insulin glargine combined with insulin glulisine and with insulin detemir          combined with insulin glulisine, in type 1 diabetics.        -  To record the intra- and inter-daily variability using the MAGE and MODD indices          [1,2,3,4]        -  To compare the glycaemic profiles (7 points)        -  To evaluate the HbA1c concentration, at the end of each period of treatment, weight          change, the dose of insulin used and the number of daily injections.      Tolerance:        -  To record undesirable events        -  To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic,          diurnal, nocturnal, severe).   "
185976|NCT00271297|"     Background:      The pelvic floor muscles (PFM) are located inside the pelvis, surrounding the urethra, vagina     and rectum. They provide structural support for the pelvic organs. Dysfunctional PFM can lead     to urine and fecal incontinence, pelvic organ prolapse (POP), sexual problems and chronic     pain syndromes. POP increases with age, parity and weakness in the PFM. Symptoms associated     with POP are backache, bladder, bowel and sexual dysfunction, and pelvic heaviness. Thus the     condition is debilitating and can greatly affect the quality of life, interfering with     day-to-day activities and reduce participation in physical activity.      The aim of the project:      As life expectancy increases, more women may experience POP. Hence it is important to prevent     and treat the condition at an early stage. Despite being a common disorder among women,     little research has been done on POP. The aim of this study is to evaluate the effect of     pelvic floor muscle training (PFMT). PFMT is a non-invasive method with no adverse effects.     If there is significant effect, the main goal is to incorporate this method in clinical     practice among physiotherapists and medical doctors. If PFM training is effective, more     emphasis of PFM training can be put into regular female fitness programs. The prevalence of     POP increases with age.      Method:      This is a single blind randomised controlled trial to evaluate the effect of PFMT on POP. 100     women with POP will be randomised to either training or control group. The training programme     will last for six months, training once a week with a physiotherapist in addition to a     structured home training programme. A blinded case-control study will also be carried out. 50     women without POP will be matched for age and vaginal deliveries. Before starting the RCT     study, a reproducibility study on perineal ultrasound will be carried out in 18 women.   "
185977|NCT00271310|"     The effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on     lung function, incidence of respiratory tract infections, quality of life, quantitative     microbiology and sputum cytokine profile. The hypothesis is that regular inhalation of     nebulised hypertonic saline will have a beneficial effect on lung function and other clinical     outcomes with no adverse effects on infection and inflammation in adults and children with     cystic fibrosis.   "
185978|NCT00271323|"     -  Primary : To determine the safety profile of each treatment group.        -  Secondary : To determine efficacy in term of overall response, disease free survival and          survival at 1 and 2 years.   "
185979|NCT00271336|"     Pentoxifylline improves microcirculation and decreases TNF alpha levels associated with     sepsis, rendering it of potential therapeutic value in necrotizing enterocolitis in premature     neonates.   "
185980|NCT00271349|"     Eosinophilic Esophagitis (EE) is a chronic, T-helper 2 cell (TH2) - type inflammatory     disorder of the esophagus with a rapidly increasing prevalence. Studies analyzing the natural     course of EE provide strong evidence, that the chronic inflammation leads to irreversible     structural changes in the esophagus with a loss of the mucosal elasticity and a fibrosis of     the sub-epithelial esophageal layers with a concomitant risk of impairment in function.      Treatment strategies in chronic inflammations have, in general, two main goals: 1) Relief of     symptoms and 2) Prevention of long-term damage of the affected organ. Until now, the     treatment of EE is still controversial. Standard recommendations for therapy of this chronic     eosinophilic inflammation include dilation, systemic or topical corticosteroids and     leukotriene antagonists. Several of these reports demonstrate, that topical corticosteroids     may be effective for symptom control as well as for down-regulating the local inflammation.     Furthermore it has been demonstrated, that treatment with topical corticosteroids is as     effective as oral prednisone. However, the majority of therapeutic recommendations are based     on clinical observations, case reports or small case series.      The purpose of this study is the evaluation of the efficacy and the safety of a monotherapy     with a topical corticosteroid as short-term induction-treatment and as long-term,     maintenance-treatment compared with placebo, in the treatment of adult patients with active     EE.   "
185981|NCT00271362|"     The purpose of the study is to compare the effect of different lower limb amputation surgical     procedures on leg bone integrity and rehabilitation outcome.   "
185982|NCT00271375|"     This project implemented and evaluated the Rosalyn Carter Institute's (RCI's) educational and     support program for caregivers, Caring for You, Caring for Me. Specifically, it examined     effects of the program upon family caregivers to older adults in the Atlanta area and elderly     Veterans receiving outpatient primary care at the Atlanta Veterans Affairs Medical Center     (VAMC).   "
185985|NCT00271414|"     The objective of this study is to assess the safety and clinical utility of DuragesicÂ® 12.5     micrograms/hour (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the     treatment of children ages 2 to 12 with continuous pain requiring narcotic pain relief     therapy. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be     assessed.   "
185986|NCT00271427|"     Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb     in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg.     It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes     against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX     activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that     If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be     blocked by saturation of deficient stores of GPX solely and the mechanism of action requires     more than repletion of deficient stores. It's important not only to estimate the optimal dose     but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels     in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment     modality which can suppress the autoimmunity in more than 400 million AIT patients. Because     there've been no way to suppress autoimmune war and replacement of LT4 had been the only     treatment modality for palliation. An other independent part of the study is to test the     effect of Se in adolescent AIT patients.   "
186300|NCT00275600|"     This study is being done to find out what effects Vitamin E or Evening Oil of Primrose has on     cyclical breast pain.   "
185989|NCT00271466|"     The objective of this study is to assess the safety of treatment with Duragesic® (a     transdermal patch delivering the narcotic pain-reliever fentanyl) in doses of 12.5, 25, 50,     75 and 100 micrograms/hour in pediatric subjects requiring narcotic pain relief therapy.     Particular attention is paid to appropriate dose conversion to Duragesic® therapy from the     subject's current narcotic pain relief therapy, and to the parameters for increasing the     Duragesic® dose to achieve analgesic effectiveness. Pharmacokinetics (fentanyl levels in the     bloodstream during treatment) will also be assessed.   "
185990|NCT00271479|"     Hypothesis:      Lower doses of each A/C/Y/W135 component of the meningococcal polysaccharide vaccine could     confer a similar functional immunogenic response as the dose of 50 μg currently being used,     and subsequently be equally protective.      The purpose of this study is to evaluate the use of fractional dose tetravalent meningococcal     polysaccharide vaccine to control outbreak especially caused by N. meningitidis serogroup     W135      Primary Objectives:        -  To measure the immunogenicity of a dose corresponding to one fifth of the amount of the          licensed meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 10 μg for each component;          and        -  To measure the immunogenicity of a dose corresponding to one tenth of the licensed          meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 5 μg for each component.   "
185991|NCT00271492|"     Qualifying patients who are scheduled for angiogram with endothelial function testing are     approached to participate in this protocol (consent form reviewed with patient). Those who     are willing to participate will have additional measurements taken during their angiogram as     part of this protocol. Patients who are diagnosed with Endothelial Dysfunction as a result of     a clinically indicated angiogram will be eligible to participate in a 6 month medication     trial (Atrasentan vs. placebo - randomized, blinded trial). Patients are monitored closely     during the 6 month trial via phone calls and blood testing for assessment. At the end of the     6 months they return to Mayo for a repeat angiogram to assess endothelial function for any     changes or improvements.   "
185992|NCT00271505|"     The goal of this clinical research study is to evaluate the effectiveness of Avastin® in     combination with docetaxel and carboplatin in the treatment of lung cancer. The safety of     this combination will also be studied.   "
185993|NCT00271518|"     The purpose of this study is to compare a new weekly administered growth hormone preparation     with standard daily treatment in children with insufficient secretion of growth hormone   "
185994|NCT00271531|"     The purpose of this study is to develop a scoring system to allow doctors to accurately     identify children on a mechanical ventilator who have bacterial pneumonia. Currently this     diagnosis is very difficult to make, resulting in the overuse of antibiotics and the     promotion of antibiotic-resistant bacteria in the pediatric intensive care unit (ICU). Four     ICUs at 3 children's hospitals will participate. Study participants will include 150     children, ages 2 months to 17 years old who require mechanical ventilation, and in whom the     bedside health care providers suspect bacterial pneumonia. Bacteria will be studied by     sampling lung fluid through the breathing tube less than 12 hours after starting antibiotics,     using a procedure known as non-bronchoscopic-bronchoalveolar lavage (NB-BAL). Participants     may be involved in study related procedures for up to 31 days.   "
185995|NCT00271544|"     Heart failure is a progressive disease that decreases the pumping action of the heart. This     may cause a backup of fluid in the heart and may result in heart beat changes. When there are     changes in the heart beat sometimes an implantable heart device is used to control the rate     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may     be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the     upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles     through three or four leads (flexible insulated wires) that are inserted through the veins to     the heart. The purpose of this study is to evaluate a new lead for delivering energy to the     left ventricle (bottom left chamber of the heart).   "
185996|NCT00271557|"     The purpose of this safety study is to evaluate NATRECORÂ® hBNP (a recombinant form of the     natural human peptide normally secreted by the heart in response to heart failure), in     subjects with worsening congestive heart failure for whom inpatient intravenous therapy with     medications that influence the tone and caliber of blood vessels is deemed appropriate.   "
185997|NCT00271570|"     This study evaluates the safety of infliximab in infants and children with acute Kawasaki     Disease.   "
185998|NCT00271583|"     Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new     antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception      Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of     CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception      Subjects are randomized to receive a one-time treatment with either one dose of 50 mg     CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with     follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days     after expected onset of menses (if needed)      The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency     postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.   "
185999|NCT00271596|"     This research plan proposes to conduct a double-blind, placebo-controlled pilot clinical     trial in 36 adults with mild Huntington's disease (HD) to address the following research     aims:        1. To determine the effect of citalopram compared to placebo in patients with early HD on          executive function and other outcome variables including functional measures          (health-related quality of life, work productivity, and self-reported attention), motor          performance, and psychiatric status,        2. To study the relationship between executive function and functional status in patients          with early HD after selective serotonin reuptake inhibitor (SSRI) treatment, and        3. To examine the effect of citalopram treatment on volumetric and metabolic (i.e,          N-acetyl-aspartate concentration) measures in the neostriatum among patients with          recently diagnosed Huntington's disease.   "
186012|NCT00271778|"     Mastoidotympanoplasty is a recognised surgery that is performed for chronic otitis media. But     whether mastoidectomy in addition to tympanoplasty is really necessary in each and every case     of quiescent chronic otitis media still remains controversial. Hence this study has been     undertaken to study the differences in the outcomes of the 2 surgical procedures performed     for chronic otitis media in a randomized control design.   "
186000|NCT00271609|"     Background:      Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels     in tumors. Inhibiting the formation of these blood vessels may slow or stop disease     progression by diminishing the supply of life-sustaining nutrients and oxygen the blood     delivers to the tumor.      Bevacizumab is approved for treating colorectal cancer and has shown activity against brain     tumor cells in laboratory and animal tests.      Objectives:      To examine the safety and side effects of bevacizumab in patients with recurrent brain     tumors.      To determine the anti-tumor activity of bevacizumab in patients with recurrent brain tumors.      Eligibility:      Patients 18 years of age and older with a brain tumor that continues to grow after receiving     standard treatments.      Design:      Patients complete the following procedures during the study:        -  Infusions of bevacizumab through a vein once every 2 weeks in 4-week treatment cycles.        -  Positron emission tomography (PET) scan before the first dose of bevacizumab, at the end          of the first treatment cycle, and as needed after that.        -  Magnetic resonance imaging (MRI) scan before the first dose of bevacizumab, within 48-96          hours after the first dose of bevacizumab in the first treatment cycle, and then every 4          weeks. One tube of blood for research is collected at the time of each MRI scan to look          at specific cells.        -  Physical and neurological examinations every 2 weeks for the first treatment cycle and          then every 4 weeks.        -  Quality-of-life questionnaires every 4 weeks.   "
186001|NCT00271622|"     This study will screen children and adolescents (and their parents) to determine the child's     eligibility for participation in NIMH research studies on autism spectrum disorders, such as     autism and Rett's Disorder.      Screening evaluations include some or all of the following procedures:      Parent interview      Parent and child evaluations including:        -  Diagnostic interview        -  Developmental or cognitive testing        -  Ratings of psychiatric and medical symptoms        -  Neuropsychological testing        -  Personal, social an family history      Child physical examination and possible blood draw      Children who are determined eligible for a current NIMH research protocol are invited to     participate.   "
186002|NCT00271635|"     Charcot-Marie-Tooth type IA (CMT1A) is the most prevalent hereditary peripheral neuropathy.     Demyelination of peripheral nerves is the hallmark of CMT1A. Ascorbic acid has been shown to     have a favorable influence on myelination in in vitro studies and in a mouse model for CMT1A.     We will study the efficacy and safety of ascorbic acid treatment in young patients with     CMT1A.   "
186003|NCT00271661|"     Chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition     known as presbyopia. Presbyopia is the inability to focus the eye on close objects, by a     process called accommodation. It is caused by an increase in the stiffness of the lens of the     eye that occurs naturally with aging. Currently, there are no known treatments that can be     used to prevent or delay presbyopia. As a result, the risk, in later life, of having this     condition is essentially 100%.      The purpose of this research is to determine whether chemotherapy drugs are delaying the age     at which people develop symptoms of presbyopia. We hope to establish that presbyopia can in     fact be delayed with the use of drugs, which would ultimately lead to further research in     this area.   "
186004|NCT00271674|"     The purpose of the study is to compare patient satisfaction, clinical efficacy and adverse     effects of Q-switched YAG laser versus punch biopsies for the treatment of tattoo dots that     are applied as skin markers in relation to X-ray treatment of malignant disorders.   "
186005|NCT00271687|"     This study aims to provide preliminary data on the feasibility and outcomes of a 12 week     exercise program on the quality of life of men with hormone refractory prostate cancer     receiving docetaxel-based chemotherapy.   "
186006|NCT00271700|"     This study will examine whether new processes and technologies for monitoring diabetic     patients' insulin levels improves patient care at Brigham and Women's Hospital.   "
186007|NCT00271713|"     Efficacy:      To investigate changes of structural bone properties in vivo using 3DpQCT (Xtreme CT,     Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis.      Major structural bone parameters which determine bone strength and predict fracture risk     earlier and more precisely are measurable in vivo by 3DpQCT.      Safety:      To assess the tolerability and safety of ibandronate therapy   "
186051|NCT00272324|"     This is a randomized controlled trial of aspirin and/or folate supplementation for the     prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.   "
186052|NCT00272337|"     The purpose of the study is to test higher versus lower doses of aspirin on markers of     atherosclerosis in patients who have had a heart attack.   "
186088|NCT00282828|"     This study will compare the effectiveness of either adding clonazepam or placebo to standard     treatment or switching to venlafaxine in treating generalized social anxiety disorder in     individuals who have not responded to treatment with sertraline.   "
186008|NCT00271726|"     This is a prospective, randomized, multi-center pilot study of unstable extraarticular     fractures of the distal radius with dorsal displacement of the distal fragment in elderly     patients. The patients are randomly assigned to osteosynthesis with palmar locking plate,     external fixator, or Kirschner wires.      The aim of this pilot study is to allow a sample size calculation for a main randomized     controlled trial (RCT). The primary outcome criterion is the functional status measured by     the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria     are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a     pilot study it is intended to generate a study hypothesis for the main RCT.   "
186009|NCT00271739|"     The IDEATel study is a multicenter randomized controlled trial to evaluate the efficacy,     acceptability, and cost-effectiveness of telemedicine case management to provide diabetes     care to elderly Medicare beneficiaries residing in medically underserved areas of New York     State.   "
186010|NCT00271752|"     This is a randomised, single blinded, multicentre trial to evaluate whether daily     procalcitonin (PCT) measurements and immediate diagnostic and therapeutic responses to     abnormal values and day-to-day changes can reduce the mortality of critically ill patients in     the Intensive Care Unit (ICU).   "
186011|NCT00271765|"     The primary purpose of this study is to assess the safety of INO-1001 in subjects who have     experienced a heart attack and are to be treated with coronary angioplasty.   "
186314|NCT00275821|"     The study will test if the efficacy and safety of an alternative dosing regimen is as     effective as monthly injections.   "
186016|NCT00271830|"     Sexual dysfunction is common in male patients with chronic renal failure on dialysis and     after renal trasnplantation. Multiple factors play a role in this important clinical problem.     Recent studies suggest that certain immunosuppressive medication used for solid organ     transplant may affect male sexual function. The purpose of this study is to compare the     sexual function of male renal transplant patients on sirolimus and those patients not on     sirolimus immunosuppression.   "
186017|NCT00271843|"     This study evaluates multi-attribute utility, a modification of subjective expected utility,     as a descriptive model of the adolescent's decision to initiate smoking or alcohol use.     According to the model, the young decision maker envisions a set of consequences that will     follow the two decision options, either to continue as a non-user or to initiate usage. Each     consequence has three components. The components are the worth of the consequence, which may     be positive or negative, the judged likelihood that the consequence will happen, and the     importance of the consequence. Within an individual, importances will change with mood or     circumstance, which is how the model accounts for impulsive decisions that may occur in     social settings.      The model will be tested by eliciting components of ten independent consequences from a large     group of students early in the seventh-grade year. Current usage will also be examined;     extant data suggest that most students will be non-users at that time. It is known that a     fair amount of initiation takes place during the seventh and eighth grade years. The     hypothesis is that those non-users whose model scores are high will be more likely to     initiate usage than those whose scores are low. The same students will be queried regarding     usage eighteen months later to evaluate the hypothesis.      It is now well known that differential knowledge regarding the harmful effects of drug use     does not distinguish adolescent users from non-users. The model approach quantifies the idea     that anticipated positive consequences play a prominent role in the decision of those who     choose to initiate. An important implication is that prevention campaigns might profit by     addressing positive as well as negative consequences of usage.   "
186018|NCT00271856|"     To examine the effects of Mindfulness-Based Stress Reduction (MBSR) and education groups on     HIV (Human Immunodeficiency Syndrome) infection. Key outcomes include CD4 and viral load,     stress hormones, depression and quality of life.   "
186019|NCT00271869|"     Chronic graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic     stem cell transplantation and the leading cause of death more than 2 years after     transplantation.During the past 30 years survival of patients with chronic GVHD has not     improved and steroids remained the most often used therapy. Extracorporeal photoimmunotherapy     (ECP)has shown to be efficacious in patients with GVHD. We propose a phase II study to     evaluate the safety and efficacy of ECP as adjunct first-line therapy in patients with newly     diagnosed chronic GVHD of liver or lungs and need for systemic immunosuppression defined     according to the NIH consensus criteria.   "
186020|NCT00271882|"     This is a qualitative study using a purposive sampling methodology to interview HIV-positive     female adolescents who have experienced physical and/or sexual abuse. An open-ended, in-depth     interview, occurring over one to two sessions, will be conducted with each participant.   "
186021|NCT00271908|"     During Phase III, Adolescent Trials Network for HIV/AIDS Interventions     (ATN)/Connect-to-Protect (C2P) site staff, their official community partners established in     Phase I, and newly invited community sector representatives (i.e., individuals from various     key parts of the community such as family, spiritual or faith-based institutions, business     and government) will form a coalition that will work toward achieving C2P objectives. ATN     040b is the evaluation protocol for ATN 040, Phase III of C2P.   "
186022|NCT00271921|"     The purpose of this study is to examine whether body fat distribution changes that occur with     weight gain in women recovering from anorexia nervosa are transient or persistent, and if     they are associated with other features of Metabolic Syndrome.   "
186023|NCT00271934|"     In patients with systemic lupus erythematosus, immunosuppressive therapy to the point of     complete immune ablation and hematopoietic stem cell recovery.   "
186024|NCT00271947|"     Crohn's disease (CD) is a chronic illness, immunologically mediated, probably induced by the     exposure of the intestine to an antigen or antigens similar to the intestine, to which     immunologic tolerance is lost or a dysregulated immunity ensues. The disease has a variable     course, from a mild, intermittently active illness requiring only symptomatic therapy to a     fulminant illness requiring potentially dangerous immunosuppressive therapy, surgery or both.     The molecular defect causing CD has not been characterized, but probably involves aberrant T     cell function. Although CD often responds to immunosuppressive medication including     corticosteroids, azathioprine and 6-mercaptopurine, to anti inflammatory drugs such as 5     aminosalicylate (5 ASA), or to some antimicrobial agents, including metronidazole, no therapy     has been curative. In patients with severe CD, who have been unresponsive to corticosteroids,     azathioprine, 5 ASA, metronidazole, and infliximab, we propose to compare the efficacy of     Crohn's disease non-myeloablative autologous hematopoietic stem cell transplantation (CDNST)     to standard therapy. Subsequent disease activity will be followed by (1) Crohn's disease     activity index (CDAI), (2) a more global severity index, the Crohn's Severity Index, (3) type     and amount of therapy for CD, and (4) clinical, hematologic and biochemical studies.   "
186025|NCT00271960|"     This study will determine the effectiveness of two group prenatal care programs as compared     to individual prenatal care in reducing the risk for HIV, STDs and adverse perinatal outcomes     in young women during and after pregnancy.   "
186026|NCT00271973|"     Thirty-two healthy volunteers will be submitted to experimental pain and on the 2 study days     receive Oxycodone 20 mg po vs. placebo. Half of the volunteers will be poor metabolizers     according to CYP2D6 genotype and half will be extensive metabolizers (EM) and have an enzyme     with normal function. The study hypothesis is that PM will experience less pain relief than     EM.   "
186027|NCT00271986|"     Anastomotic leakage is a serious complication after LAR with high morbidity and mortality     rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to     investigate the clinical use of peritoneal microdialysis and whether is able to detect     anastomotic leakage prior to clinical symptoms develops.   "
186208|NCT00284414|"     Patients with Morton neuroma of the foot will undergo either ultrasonography or MRI. The     results will be compared.      In case of surgery, the pathology report will be compared with the ultrasonographic or MRI     findings.      Which is the most reliable and specific: ultrasonography or MRI?   "
186028|NCT00271999|"     The Frequent Hemodialysis (FHN) Nocturnal Trial is a randomized controlled trial recruiting     subjects from dialysis units associated with designated Clinical Centers in the U.S. and     Canada and followed for 12 months. Subjects will be randomized to conventional hemodialysis     delivered three days per week home arm or to the six times per week nocturnal home     hemodialysis arm which will follow any dialysis prescription provided their prescribed     standardized Kt/V is at least 4.0 and treatment time is at least 6.0 hours, six times per     week.   "
186029|NCT00272012|"     Primary objective:      The primary study objective is to compare efficacy of Insulin glulisine, once a day at     breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin     glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual     patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy     regimens receiving two different injection timing of Insulin glulisine.      Secondary objective:      Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a     day at breakfast vs. Insulin glulisine given once a day at main meal in combination with     insulin glargine + OAD in terms of:        -  Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose          (baseline to endpoint)        -  Change of fasting plasma glucose (baseline to endpoint)        -  Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study          endpoint        -  Insulin dose (rapid-acting, basal and total daily doses)        -  Weight, body-mass index        -  Hypoglycemic events        -  Adverse events   "
186030|NCT00272025|"     To determine if adding Escitalopram to current mood stabilizer (MS) or atypical antipsychotic     (AA) will improve in rates similar to or better than adding a placebo (inactive pill)in     resistant bipolar patients.   "
186031|NCT00272038|"     Objectives to evaluate the activity of Erlotinib in prostate cancer patients who are hormone     refractory and androgen independent and have not been exposed to chemotherapy.   "
186032|NCT00272051|"     Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity     of the Oxaliplatin and 5-FU/LV chemotherapy, in patients with metastatic colorectal     carcinomaPrimary objectives : Compare the risk of occurence of grade 3-4 peripheral sensory     neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo     group ; Compare the response rate between treatment group and placebo group.Secondary     objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to     recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free     survival, overall survival) ; safety profile.   "
186033|NCT00272064|"     -  The primary objective of the present study is to verify the superiority of Telecare          program vs. standard SMBG program in terms of mean HbA1c value (- 0,5%) at end-point.        -  The secondary objectives of the study are the assessment of: total daily dose of          insulin, changes in glycaemic and lipid profile, frequency of hypoglycaemias, changes in          weight, health-related quality of life, cost-effectiveness of Telecare program vs.          common ambulatory program; general safety (adverse event profile, other routine          laboratory parameters).   "
186034|NCT00272077|"     Primary objective:      To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability     (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose).      Secondary objectives:      The secondary objectives are the assessment of: changes in glycaemic control (HbA1C),     frequency of hypoglycaemias, changes in weight, final insulin dose, changes in lipid     parameters, changes in urinary albumin-to-creatinine ratio, profile of patient which best     fits each of the algorithms with the dependent variable of change in HbA1C and independent     variables of age, gender, race, tobacco use, diabetes complications, initial HbA1C, initial     weight, duration of diabetes mellitus, general education and diabetes education.   "
186035|NCT00272090|"     The primary purpose of the protocol is to demonstrate that the new regimen (insulin     glargine+regular insulin ) is no worse than the reference regimen (insulin glargine+lys-pro     insulin ) in reducing the incidence of severe nocturnal hypoglycemia at the end point; the     secondary purpose is to compare the two study regimens as far as the glycemic control     (measured by HbA1c), the daily Mean Blood Glucose (MBG) and the mean amplitude of glycemic     excursion (MAGE index), calculated on the basis of Self Monitoring Blood Glugose (SMBG) data,     are concerned and to verify the safety of basal insulinization with Lantus.   "
186037|NCT00272116|"     Zinc deficiency is common in developing country children, as food intakes are often low,     foods from animal sources are infrequently used, the bioavailability of zinc from staple     cereal-based diets is limited and zinc losses occur during recurring diarrheal illnesses.     Zinc deficiency is associated with impairment in immunological and other defenses against     infection and increased rates of serious infections. Due to limitations in currently used     biochemical markers, supplementation trials in populations likely to be deficient provide a     reliable means of assessing health consequences of zinc deficiency.      A significantly lower incidence and prevalence of diarrhea has been observed in zinc     supplemented developing country children in several placebo-controlled trials. The effect of     routine zinc supplementation on lower respiratory tract infection is still unclear. We,     therefore, evaluated the impact of daily zinc supplementation in a representative sample of     children aged 6 to 30 months enrolled from a New Delhi slum area, with a sample size     sufficient to determine the impact on the incidence of severe diarrhea and acute lower     respiratory infection.   "
186061|NCT00278590|"     This trial is designed to evaluate the safety of treating systemic lupus erythematosus     participants with cyclophosphamide and CAMPATH-1H followed by allogeneic stem cell     transplant. There will be no randomization in this study. All subjects who are determined to     be eligible for the study treatment will receive cyclophosphamide and CAMPATH-1H followed by     allogeneic stem cell transplant. The purpose of the intense chemotherapy is to destroy the     cells in the immune system which may be causing this disease. The purpose of the stem cell     infusion is to produce a normal immune system that will no longer attack body. The study     purpose is to examine whether this treatment will result in improvement in the lupus disease.   "
186062|NCT00278603|"     Severe peripheral vascular disease of the legs causes narrowing of the blood vessels in the     legs, which keeps the blood from flowing adequately through these vessels. This study is     designed to examine whether treating patients with their own previously collected blood stem     cells will improve blood flow in the most severely affected leg. Blood stem cells are     undeveloped cells that have the capacity to grow into mature blood cells, which normally     circulate in the blood stream.   "
186038|NCT00272142|"     There are currently no interventions available to substantially reduce the incidence of low     birth weight (LBW) apart from increasing the age at marriage, maternal iron supplementation     and possibly improved energy intakes.      The current view of the medical and public health community in India is that the immediate     focus should be on promoting survival and development of low birth weight infants who have     nearly a 6 to 7 fold higher mortality during infancy than those with normal birth weight.      Low serum zinc is associated with increased incidence of diarrhea and pneumonia. There is     sufficient evidence in under-threes that during acute illness, zinc supplementation (1-2     recommended dietary allowance [RDA]) reduces incidence of all episodes of diarrhea, severe     diarrhea and pneumonia. A number of initial published trials also show significant effect of     zinc treatment on pneumonia. With the large and consistent effects of zinc supplementation on     the incidence and severity of infections, an effect on child mortality is likely.      Available literature suggests the distinct possibility of reduced neonatal and infant     mortality in LBWs receiving 1 RDA of zinc daily. A pilot study in India showed a 54%     reduction in mortality in LBW infants. These findings were based on a very small sample and     therefore considered insufficient to change policy.      A positive impact in the proposed study will provide an important tool for reduction of     infant mortality which is currently stagnant and government acceptance for such a program is     likely to be very high. We, the researchers at the Society for Applied Studies, believe this     study has the potential for decreasing infant mortality from its current level.   "
186039|NCT00272155|"     This study will explore the possible effect of a tailored educational intervention towards     general practitioners, in order to improve antibiotic prescriptions for respiratory     infections.   "
186040|NCT00272168|"     The goal of this study is to evaluate the efficacy of a combined social skills training and     cognitive-behavioral therapy intervention for seriously mentally ill Veterans as they begin     employment.   "
186041|NCT00272181|"     The purpose of this study is to determine the safety, effectiveness, and recommended dose of     Proxinium in North American patients with Squamous Cell Head and Neck Cancer   "
186042|NCT00272194|"     The purpose of this study is to determine if the Ambu Laryngeal Mask can be used as an     intubation conduit for endotracheal intubation.   "
186043|NCT00272207|"     The purpose of the study is to determine whether or not the drug Nabilone significantly     reduces pain and improves quality of life in patients with fibromyalgia.   "
186044|NCT00272220|"     Our study is a randomized controlled trial that aims to evaluate the effectiveness of     modified directly observed therapy (mDOT) to (1) increase both short and long term adherence     to HAART treatment, and (2) improve clinical outcomes associated with HAART therapy.      Our hypothesis is that modified directly observed therapy (mDOT) during the initial 6 weeks     of HAART, supervised primarily by HIV-positive lay activists, will improve adherence and     clinical outcomes compared with those that do not have supervised mDOT. We also hypothesize     that the benefits of mDOT will be achieved through a variety of mediators that will result     from the social interactions the patients will have with the activists. These mediators     include improved social support, improved knowledge about HAART, reduced stigma, and improved     self-efficacy.   "
186045|NCT00272233|"     Work requirements for medical trainees result in substantial sleep loss. Sleep loss has been     associated with increased levels of certain inflammatory hormones that could have negative     impact on blood vessel function. The purpose of this study is to determine the effects of     sleep loss on blood hormone levels and blood vessel function in medical trainees.   "
186046|NCT00272246|"     Primary generalized dystonia, also called idiopathic torsion dystonia or dystonia musculorum     deformans is a disabling neurological condition which usually starts in childhood, mostly in     a lower limb and spreads to other body parts as the disease progresses. Medical treatment is     usually ineffective and most patients become wheelchair bound or even bedridden. Recently     several case series and one RCT reported favourable results of bilateral deep brain     stimulation (DBS) of the globus pallidus internus (GPi) for primary generalized dystonias.     However, the number of patients treated with bilateral GPi stimulation is still limited.     Therefore, we propose a RCT to investigate whether bilateral DBS of the GPi is an effective     and safe treatment in patients with primary generalized dystonia.   "
186047|NCT00272259|"     The investigators are looking for individuals who have suffered a stroke to participate in an     experiment examining the use of robotics in rehabilitation. They are trying to develop a     robotic environment for hands after having had a stroke. Participants will interact with up     to two small robots and a visual display. The experiment involves minimal risk and may     involve testing sessions over multiple weeks. Subjects must be at least 1 year post-stroke     and have difficulty picking up small objects.      For more information, contact: Bambi Brewer, CMU Ph.D. Student, 412-241-9423 or     bambi@andrew.cmu.edu.   "
186048|NCT00272272|"     Falls are the largest cause of death in the elderly and those with dementia have even a     higher incidence of falling. The purpose of this study is to determine whether listening to     the Music of Nolwenn Leroy is effective in fall prevention in those elderly patients who are     residents in a Geriatric Nursing Home Facility. The music of Nolwenn Leroy has been shown to     be effective in fall reduction in a different setting (Posturographic Changes and Fall     Prevention associated with Music Therapy: The Nolwenn Effect (USA ClinicalTrials.gov     Identifier: NCT00121693) )with results better than listening to Mozart of any other music.   "
186053|NCT00272350|"     Background:      In vivo experiments have documented the ability of ZD6474 to inhibit tumor growth in various     preclinical tumor models. Given the pronounced neovasculature associated with malignant     gliomas, and abundant published data demonstrating the dependence of glioma growth on the     maintenance and proliferation of this neovasculature, ZD6474 represents a potentially     promising new therapeutic approach to these otherwise refractory tumors.      Thus, we now propose a phase I trial of ZD6474 in patients with recurrent and progressive     low-grade gliomas who are on P450-inducing anti-epileptic drugs and a phase II trial for     patients with recurrent gliomas not taking P450-inducing anti-epileptic drugs.      Objective:      Phase I - To establish the maximally tolerated dose of ZD6474 and to obtain preliminary     information regarding the spectrum of toxicities of ZD6474, and to obtain pharmacokinetic     data to patients taking EIAED.      Phase I - To obtain preliminary information regarding potential anti-tumor activity of ZD6474     in patients taking EIAED.      Phase II - To establish data regarding the anti-tumor activity of ZD6474 and to collect     information regarding the spectrum of toxicities in patients not taking EIAEDs.      Eligibility:      Patients with histologically proven malignant primary gliomas will be eligible for this     protocol. Additionally, patients with progressive low-grade gliomas and patients with     infiltrative brain stem gliomas, diagnosed radiographically rather than by biopsy will also     be eligible.      Design:      Phase I - Group B patients will be accrued to the formal dose-escalation phase I trial.     Groups of patients with recurrent high-grade gliomas will be accrued to increasingly higher     doses of ZD6474 until the MTD is established.      Phase II - Patients will be treated at a dose of 300 mg day, every day, on a 4-week cycle.   "
186055|NCT00278512|"     The systemic vasculitis is a wide-ranging group of diseases that are characterized by the     presence of blood vessel inflammation (1). Despite this common feature, each type of     vasculitis has a unique variety of clinical manifestations that influences its degree of     disease severity and ultimately its management. Immunosuppressive therapy forms the     foundation of treatment for almost all forms of systemic vasculitis.      The systemic necrotizing vasculitis (SNV) are a subset of vasculitis with significant     morbidity and mortality (2). The SNV are Wegener's granulomatosis, allergic angiitis and     granulomatosis (AAG) (also known as Churg-Strauss syndrome), polyarteritis nodosum (PAN),     microscopic polyangiitis (MPA), and overlap syndrome. In spite of modern therapeutic immune     suppressive agents, there remains a not inconsequential morbidity and mortality associated     with SNV. The current standard therapy for SNV is chronic oral cyclophosphamide (1-3     mg/kg/day) and corticosteroids (3-6). Transplant doses of cyclophosphamide at 200 mg/kg     infused over 4 days is the most common worldwide transplant regimen for systemic lupus     erythematosus (SLE) (7). Like SLE, SNV are cyclophosphamide responsive disease. We,     therefore, propose a trial of high dose cyclophosphamide with anti-thymocyte globulin (ATG)     for patients with SNV.   "
186056|NCT00278525|"     Scleroderma is a systemic disorder categorized as an immunologically mediated disease that     causes collagen deposition of skin and visceral organs. The molecular pathogenesis of     scleroderma has been elusive, although vasculopathy and immune mediated mechanisms are     thought to be important. Once extensive cutaneous or visceral disease occurs, prognosis is     significantly shorter than the general population. Although various treatments have been     tried, none of them seems to have changed the natural history of scleroderma. Standard dose     immunosuppressive treatment has been disappointing. Recently, cyclophosphamide at 1-2     mg/kg/day orally or 800-1400 mg intravenous (IV) monthly for 6-9 months has proven effective     in treatment of scleroderma alveolitis (1). Recent phase I studies of immunoablation with     autologous peripheral blood stem cell transplantation (PBSCT) showed some promising data, but     the exact efficacy is undetermined (2,3). We now propose, as a phase II randomized study,     autologous unmanipulated PBSCT versus pulse cyclophosphamide in patients with systemic     scleroderma.   "
186057|NCT00278538|"     This study is designed to examine whether treating patients with lupus with high dose     cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune     system), followed by return of their previously collected stem cells will result in     improvement in the disease. Stem cells are undeveloped cells that have the capacity to grow     into mature blood cells, which normally circulate in the blood stream. The purpose of the     intense chemotherapy is to destroy the cells in the immune system which may be causing this     disease. The purpose of the stem cell infusion is to produce a normal immune system that will     no longer attack body. The study purpose is to examine whether this treatment will result in     improvement in the lupus disease.   "
186058|NCT00278551|"     Rheumatoid arthritis (RA) is a chronic illness, immunologically mediated, probably induced by     the exposure to an antigen or antigens, to which immunologic tolerance is lost. The disease     has a variable course, from a mild, intermittently symptomatic illness requiring only     symptomatic therapy to a fulminant illness requiring dangerous immunosuppressive therapy,     surgery or both. The molecular defect causing RA has not been characterized, but may involve     aberrant T cell, B cell, and macrophage function. Although RA often responds to     immunosuppressive medication including corticosteroids, methotrexate, azathioprine and     cyclophosphamide, or to non-steroidal anti-inflammatory drugs, no therapy has been curative.     In patients with severe RA, who have been unresponsive to corticosteroids, and who have more     than 20 active joints or vasculitis, we propose, as a phase I-II study, complete immune     ablation and subsequent reconstitution with autologous in vitro T lymphocyte depleted PBSCs     harvested from the patient prior to immune ablation. The combination of high dose     cyclophosphamide and anti-thymocyte globulin conditioning will be followed by rescue with     autologous lymphocyte depleted PBSCs. Subsequent disease activity will be followed by: (1) RA     disease activity index, (2) type and amount of therapy for RA, and (3) flow cytometry of     peripheral blood lymphocyte subsets, (4) joint count, (5) patients' assessment of pain, (6)     arthritis impact measurement scales (AIMS) questionnaire, (7) acute phase reactants. This     study will dose standard therapy, i.e. immune suppression, to the point of complete immune     ablation and subsequent recapitulation of lymphocyte ontogeny by PBSC rescue. We anticipate     that this study will also form the basis to clarify further the role of the immune system in     RA.   "
186059|NCT00278564|"     Myositis is a disease, believed to be due to immune cells, cells which normally protect the     body, but are now attacking the muscles and other organ systems within body. As a result, the     affected muscles and organs fail to work properly causing weakness, difficulty swallowing,     skin rash, respiratory problems, heart problems, joint stiffness, soft tissue calcification     and vasculitis (blood circulation problems). The likelihood of progression of this disease is     high. This study is designed to examine whether treating patients with high dose     cyclophosphamide (a drug which reduces the function of the immune system) and ATG (a protein     that kills the immune cells that are thought to be causing this disease), followed by return     of previously collected blood stem cells will stop the progression of myositis.   "
186060|NCT00278577|"     This disease is believed to be caused by immune cells (called lymphocytes) attacking tissue.     Risk of death is highest in people with active acute disease. In addition, progressive     Crohn's Disease leads to further loss of bowel function, which may eventually result in the     need for artificial nutritional support (parenteral nutrition).      This study involves high dose chemotherapy followed by return (infusion) of blood stem cells.     Stem cells are undeveloped cells that have the capacity to grow into mature blood cells,     which normally circulate in the blood stream. The high dose chemotherapy consists of     cyclophosphamide and anti lymphocyte antibody (a protein that depletes cells that cause     damage to the body). The purpose of the intense chemotherapy is to destroy the immune system     completely. The purpose of the stem cell infusion is to restore the body's blood production,     which will be severely impaired by the high dose chemotherapy and anti lymphocyte antibody.   "
186145|NCT00283595|"     Decreased bone strength is a serious medical problem present in many women with Anorexia     Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones     than women with normal bone strength.      We are investigating whether a hormone that is naturally produced by the human body, called     growth hormone, can help strengthen the bones of women with this type of disordered eating.   "
186063|NCT00278616|"     Antiphospholipid syndrome is disease believed to be due to immune cells, cells which normally     protect the body, but are now producing the protein which leads to abnormal clotting in the     body. This study is designed to examine whether treating patients with high dose     cyclophosphamide together with CAMPATH (drugs which reduce the function of the immune     system), followed by return of the previously collected stem cells will result in improvement     in the disease. Stem cells are undeveloped cells that have the capacity to grow into mature     blood cells, which normally circulate in the blood stream. The purpose of the intense     chemotherapy is to destroy the cells in the immune system which may be causing the disease.     The purpose of the stem cell infusion is to produce a normal immune system that will no     longer attack the body. The study purpose is to examine whether this treatment will result in     improvement in the disease. The drugs used in this study treatment are drugs for commonly     used for immune suppression.   "
186064|NCT00278629|"     Chronic inflammatory demyelinating polyneuropathy is disease believed to be due to immune     cells, cells which normally protect the body, but are now attacking the nerves in the body.     As a result, the affected nerves fail to respond, or respond only weakly, to stimuli causing     numbing, tingling, pain, and progressive muscle weakness.The likelihood of progression of the     disease is high. This study is designed to examine whether treating patients with high dose     cyclophosphamide (a drug which reduces the function of the immune system) and ATG (a protein     that kills the immune cells that are thought to be causing disease), followed by return of     the previously collected blood stem cells will stop the progression of CIDP. Stem cells are     undeveloped cells that have the capacity to grow into mature blood cells, which normally     circulate in the blood stream. The purpose of the high dose cyclophosphamide and ATG is to     destroy the cells in the immune system. The purpose of the stem cell infusion is to evaluate     whether this treatment will produce a normal immune system that will no longer attack the     body.   "
186065|NCT00278642|"     Autoimmune Bullous Skin Disorders are believed to be due to immune cells, cells that normally     protect the body and are now causing damage to the body. This study is designed to examine     whether treating patients with high dose cyclophosphamide (a drug which reduces the function     of the immune system) together with anti-thymocyte globulin (a protein that kills the immune     cells that are thought to be causing your disease), followed by return of the previously     collected special blood cells (stem cells) will result in improvement of this disease. Stem     cells are undeveloped cells that have the capacity to grow into mature blood cells, which     normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy     the cells in the immune system which may be causing this skin disease. The purpose of the     stem cell infusion is to restore the body's blood production, which will be severely impaired     by the high dose chemotherapy and anti-thymocyte globulin.   "
186066|NCT00278655|"     Multiple sclerosis is disease believed to be due to immune cells, cells which normally     protect the body, but are now attacking the tissue in the brain and possibly the spinal cord.     The likelihood of progression of this disease is high. This study is designed to examine     whether treating patients with high dose cyclophosphamide and CAMPATH-1H (drugs which reduce     the function of the immune system) followed by return of previously collected blood stem     cells will stop the progression of your multiple sclerosis. Stem cells are undeveloped cells     that have the capacity to grow into mature blood cells, which normally circulate in the blood     stream. The purpose of the cyclophosphamide and CAMPATH-1H is to destroy the cells in your     immune system which are thought to be causing your disease. The purpose of the stem cell     infusion is to restore the body's blood production, which will be severely impaired by the     high dose chemotherapy and to produce a normal immune system that will no longer attack the     body.   "
186067|NCT00278668|"     We suggest to investigate serotonin uptake in schizophrenia patients receiving ECT   "
186068|NCT00278681|"     Use of zinc in diarrhea may be an effective intervention to reduce hospitalizations and child     mortality as it could reach the most vulnerable children in a community and reduce severity     of not only diarrhea but also of associated infections. It might also potentially reduce     antibiotic use.      We conducted a pilot study prior to conducting a community based controlled effectiveness     trial to assess whether addition of zinc as a therapeutic modality for diarrhea delivered     through existing channels, reduces visits to health care providers, antibiotic and other drug     use, and increases ORS use during diarrhea.   "
186069|NCT00278694|"     Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.   "
186071|NCT00278733|"     The goal of the study is to test the efficacy of brief physician advice in reducing the     frequency of high risk drinking and alcohol-related harm in a population of university     students seeking routine care at UBC Student Health Service. It is hypothesized that     receiving the intervention will reduce the amount of alcohol consumed and the incidence of     alcohol-related harm among the students in the intervention group, as compared to the control     group.   "
186072|NCT00278746|"     Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. There     was a significant reduction in duration of the treated episodes and in their severity as     measured by diarrheal stool output or frequency. Zinc is a potentially important     immunomodulator or nutraceutical which may have great impact as therapeutic agent in     conditions like diarrhea and pneumonia. The issue is whether and how zinc should be     introduced in primary health care programs for treatment of acute diarrhea. A practical,     sustainable intervention for introduction of zinc as treatment of acute diarrhoea in national     programs is therefore required. This study aimed to address this issue.   "
186110|NCT00283127|"     Urogenital Chlamydia trachomatis infection is the most common bacterial sexually transmitted     infection in Norway. Urogential C.trachomatis infection can easily be treated with     antibiotics. However, left untreated it is a major cause of pelvic inflammatory disease (PID)     that can lead to complications such as infertility, ectopic pregnancy and chronic pelvic pain     in women. Most infections are asymptomatic and many do not seek the doctor for testing.     Therefore cases remain undetected and untreated.We want to determine the efficacy and     feasibility of screening for urogenital C. trachomatis infection with home sampling     (intervention) compared to the current strategy of conventional sampling at the doctor's     office (control) in identifying men and women aged 18-25 years with urogenital C.trachomatis     infection (Part A). We also want to identify factors influencing the acceptability of home     sampling for C.trachomatis infections (Part B)and determine factors associated with     C.trachomatis infections (Part C).   "
186073|NCT00278759|"     Acute respiratory tract infections are among the most common problems of childhood,     particularly among infants and children younger than 3 years, and account for most antibiotic     prescriptions to children. Most of these infections are self-limited and do not require     medical intervention; however, the symptoms overlap significantly with those of severe viral     or bacterial infections. At the hospital Emergency Department (ED), medical assessment,     prescription of antibiotics (unnecessarily if the infection is viral), and a series of     investigations (e.g., blood work, X-rays) often take place before a decision on patient     management and possible hospital admission can be made. Such procedures lead to intense use     of human health resources (nursing, laboratory and radiology staff) and hospital facilities.      The literature suggests that a prompt single viral diagnosis improves decision-making. To our     knowledge, no-one has performed a controlled trial to examine the impact of a rapid,     multi-viral detection test like VIRAP, or the impact of the timing of such a test, on     management of children with flu-like illnesses in the ED.      Our objective is to determine if use of our new viral detection program, VIRAP, for rapid     testing for viral respiratory infections right after triage will improve patient management     and resource use in the ED. We will test the hypothesis that availability of VIRAP at triage     to support rapid diagnosis of viral infection in children at BCCH will (i) reduce the waiting     time in the ED; (ii) improve decision making regarding diagnostic investigations and specimen     collection; and (iii) decrease antibiotic prescriptions.      Study completed and manuscript accepted for publication in the Journal of Pediatrics.   "
186074|NCT00278772|"     The purpose of this research study is to evaluate the safety, tolerability, and efficacy of     divalproex extended release compared to placebo (sugar pill without medication) in the     treatment of bipolar disorder with moderate to severe hypomania or mild mania. Divalproex     extended release is approved by the United States Food and Drug Administration (FDA) for the     treatment of epilepsy and for prevention of migraine headaches.   "
186075|NCT00278785|"     The underlying hypothesis that providing brief interventions to individuals who engage in     potentially harmful patterns of alcohol use will alter their drinking behavior and therefore     avoid negative consequences. Specifically, this study aims to determine if brief     interventions will:        1. Reduce the number of re-admissions and deaths due to injuries associated with alcohol          consumption        2. Reduce the number of driving under the influence (DUI) arrests        3. Reduce harmful drinking behavior   "
186076|NCT00278798|"     The objective of this study is to compare radical hysterectomy with trachelectomy on outcomes     related to intimacy, sexual health, and mood immediately before, 1 month after, and 6 months     after surgery.   "
186077|NCT00278811|"     The purpose of this study is to compare two different kinds of follow-up care and their     effects on psychiatric service use and psychological well-being. This randomized, controlled     trial of subjects discharged from the psychiatric emergency services to outpatient care     receive traditional hospital-based outpatient clinic referrals (treatment as usual) or     appointments for community-based follow-up by a mobile crisis team.   "
186078|NCT00278824|"     A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug     Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the     treatment of breakthrough pain in adult patients with moderate to severe non-malignant     chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will     last up to 15 days. Eligible patients who complete the open-label arm will be allowed to     enroll in the double-blind study arm.   "
186079|NCT00278837|"     Women with breast cancer often suffer significant distress and disability from their disease.     A practice of meditation-based stress reduction and cognitive-affective-behavioral learning     may help women with breast cancer decrease their suffering and improve their quality of life.   "
186080|NCT00282711|"     The purpose of this study is to compare two types of exercise stress testing to find the best     method for detecting heart disease in women.   "
186081|NCT00282724|"     Lamellar ichthyosis is a congenital disease of the skin with a generalized scaling. The     primary activity of liarozole is considered to be the inhibition of the degradation of a     substance called retinoic acid, which is the principal endogenous regulator of growth and     differentiation of epithelial tissues in mammals. The current study intends to evaluate the     efficacy and safety in patients with lamellar ichthyosis.   "
186082|NCT00282750|"     The purpose of this study is to test whether bar coded surgical sponges can significantly     increase the safety of operations, specifically by (1) reducing discrepancies and miscounts,     (2) reducing total staff time spent on sponge counting, and (3) reducing disruptions to the     operating room as a system. Also, the study aims to further characterize the limitations of     the current surgical sponge counting protocol.   "
186083|NCT00282763|"     The purpose of this Study is to test the Safety and Effectiveness of MK0686 in relieving     neuropathic (chronic) pain as experienced by patients with Postherpetic Neuralgia (Also Know     as PHN or Post Shingles Pain).      This is an early phase trial and some specific protocol information is proprietary and not     publicly available at this time. (Full information is available to trial participants).   "
186084|NCT00282776|"     This study will evaluate the effectiveness of a telephone-based depression screening and care     management program in treating depression in postpartum women.   "
186092|NCT00282893|"     The purpose of this study is to determine if early transluminal ballooning of the major     cerebral arteries prevents severe vasospasm and improves neurological outcome in patients     with Fisher Grade III aneurysmal subarachnoid hemorrhage.   "
186111|NCT00283153|"     The purpose of this research is to evaluate the effectiveness of three training programs     designed to teach persons with acquired brain injury (ABI) to recognize emotions. It is     hypothesized that the training programs will enhance several aspects of emotion recognition     in persons with ABI. Furthermore, it is expected that these effects will be maintained over     time, and will positively influence participants' social behavior and integration.   "
186146|NCT00283608|"     RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving     anastrozole may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors learn more about how anastrozole works     in the body.      PURPOSE: This research study is looking at the pharmacogenetics of anastrozole in     postmenopausal women with estrogen receptor-positive (ER+) and/or progesterone     receptor-positive (PR+) stage I, stage II, or stage III breast cancer.   "
186093|NCT00282906|"     This is an National Institute of Health (NIH) funded, investigator-initiated, single center     prospective study to investigate the ability of the new dual-modality positron emission     tomography and computed tomography (PET-CT) imaging systems in comparison to conventional     imaging methods in assessing treatment response in men with metastatic prostate cancer. The     investigators will enroll two groups of men with stage IV metastatic prostate cancer, each     group will be comprised of 160 patients.        -  Group I: men with newly diagnosed hormone-responsive measurable metastatic disease who          will be treated with androgen-ablation therapy        -  Group II: men with newly-developed hormone-refractory measurable metastatic disease who          will be treated with chemotherapy and /or other therapies for hormone refractory disease      To be eligible, men in either group must have rising serum prostate specific antigen (PSA)     level - defined as at least 2 consecutive rises in PSA documented over a reference value (1st     measure within 28 days prior to recruitment). The first rising PSA (2nd measure) should be     taken at least 14 days after the reference value. A confirmatory PSA measure (3rd measure)     obtained at least 14 days after the 2nd measure is required and must be greater than the 2nd     measure. Additionally, patients must have a serum PSA concentration of at least 2 ng/mL in     addition to increasing PSA to be eligible. Patients will be followed with the PET-CT at 4, 8,     and 12 months after the initiation of androgen ablation therapy (Group I) or chemotherapy     (Group II).   "
186094|NCT00282919|"     The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.   "
186095|NCT00282932|"     An interventional active/placebo double blinded parallel randomized controlled study in which     at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is     measured along with associated safety and other secondary endpoints like bladder diary     endpoints, quality of life and patient treatment satisfaction.      Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and     Urgency of at least 1 episode per day confirmed by bladder diary).      Patients are not eligible to enroll in the study if they have/had significant hepatic or     renal disease, history of radiation treatment.   "
186096|NCT00282945|"     The purpose of this study is to determine whether markers of b-cell function can predict     changes in B-cell function over time in patients with type 2 diabetes mellitus (T2DM)     randomized to treatment with metformin or rosiglitazone.   "
186097|NCT00282958|"     To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain     but also for subacute pain.   "
186098|NCT00282971|"     To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes     who are not well controlled on 2 or more oral anti-diabetic agents   "
186099|NCT00282984|"     The primary purpose of this study is to determine whether or not varenicline will help people     with cardiovascular disease quit smoking and to confirm it is safe in these patients.   "
186100|NCT00282997|"     To evaluate the safety of pregabalin in patients with fibromyalgia.   "
186101|NCT00283010|"     The primary objective of this study is to evaluate the effects of a computer-based training     program on the memory and cognitive abilities of mature individuals undergoing healthy aging.   "
186102|NCT00283023|"     Recent developments in the understanding of stem- and progenitor cell differentiation raises     hopes that brain damage in chronic neurological diseases may become repaired by systemic or     focal transplantation of such cells. Clinical trials of stem- or progenitor cell     transplantation in multiple sclerosis are currently premature. The researchers developed a     protocol for human oligodendrocyte progenitor cell culture from human brain for the treatment     of demyelinating disease.   "
186103|NCT00283036|"     Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan     in ambulatory Hypertensive patients   "
186104|NCT00283049|"     The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to     Week 12 between the 3 treatment arms.   "
186105|NCT00283062|"     This is a prospective, multicenter, open-label, randomized phase III study in participants at     high risk of recurrent prostate cancer after radical prostatectomy. The study will     investigate        -  Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate          (ELIGARD®) versus leuprolide acetate alone (ELIGARD®)        -  Immediate treatment following prostatectomy versus deferred treatment at the time of          relapse      Using a 2x2 factorial design participants will therefore be randomized to        -  Immediate adjuvant treatment with docetaxel plus leuprolide acetate (chemotherapy and          hormonal therapy)        -  Immediate adjuvant treatment with leuprolide acetate alone (hormonal therapy)        -  Deferred treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal          therapy)        -  Deferred treatment with leuprolide acetate alone (hormonal therapy)      Primary Objective:        -  The primary objective of the study is to compare progression-free survival using a 2x2          factorial design      Secondary Objectives:        -  To compare the 5-year overall, cancer-specific and metastasis-free survival after          systemic treatment between the groups        -  To compare the safety and tolerability between Docetaxel in combination with leuprolide          acetate and leuprolide acetate alone.        -  To evaluate quality of life as measured by the FACT-P questionnaire.      Originally, 1696 participants were planned in the study (with 424 participants randomized to     each arm). However, only a total of 211 participants completed the randomization procedure as     of 26 September 2007. Thus, sanofi-aventis, in accordance with the Steering Committee,     decided to stop the participant recruitment as of 26 September 2007. Participants who had     already signed their Informed Consent (IC) before September 26, 2007 were allowed to enter     the randomization if they met eligibility criteria. The final revised number of planned     participants to be randomly assigned to the 4 treatment arms was 250, and 228 participants     were actually randomized.      The final sample size did not allow all the statistical analyses to be conducted on efficacy     data. Therefore, the protocol was amended to reflect the change in the plans for statistical     analysis. The study was underpowered to serve as the basis for drawing conclusions regarding     efficacy and quality of life (QoL) endpoints.   "
186106|NCT00283075|"     This is a phase 1 trial to evaluate the safety and toxicity of mouse kidney cancer     cell-containing agarose-agarose macrobeads that are implanted in the abdominal cavity as a     proposed biological treatment of patients with end-stage, treatment-resistant cancer. The     macrobeads have been extensively tested in tumor models in mice and rats, as well as in     forty-five veterinary patients (cats and dogs) with naturally occurring tumors of various     types including breast cancer, prostate cancer, liver cancer, and lymphoma with clear tumor     responses and no significant detectable toxicity.   "
186107|NCT00283088|"     The purpose of this trial is to evaluate if it is safe to use tissue plasminogen activator     (tPA) within 6 hours of stroke onset when combined with hypothermia.   "
186108|NCT00283101|"     This is an open-label, dose-escalation study to determine the tolerability, safety profile,     and antitumor activity of SGN-40 in patients with CLL. All patients will receive dose     escalation during the first two weeks regardless of cohort designation.   "
186109|NCT00283114|"     Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the     toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with     myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative     diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose     from phase 1a.   "
186112|NCT00283166|"     An estimate of 90% of patients with cancer experience at least moderate pain at some point in     their illness, and 42% of patients do not receive adequate palliation. The main objective of     this research is to reduce barriers to pain control by creating more effective partnerships     between patients and their health care providers. The aims of the study are: 1) to compare     the effects on pain, cancer-related symptoms, and health-related quality of life of a     standard cancer pain leaflet versus face-to-face, tailored education and coaching; 2) to     estimate the effect of tailored education and coaching on patients' self confidence for     managing their pain and participating actively in care; and 3) to examine the mechanisms     underlying the beneficial effects of the intervention. The proposed model will enhance     research on pain management in that it is a pilot-tested intervention that is applicable in     the outpatient setting, based on Social Cognitive Theory, and focused on patient activation     and education.   "
186113|NCT00283179|"     To evaluate the efficacy, safety and tolerability of aripiprazole in the treatment of acutely     relapsed patients with diagnoses of schizophrenia or schizoaffective disorder with     risperidone as an active control.   "
186114|NCT00283192|"     The primary outcome of FAST (a randomized double-blinded, placebo controlled, trial of the     effect of sertraline vs. placebo in reducing the incidence and severity of hot flushes in     healthy women) is to determine if 6 weeks of treatment with sertraline (50mg daily for 2     weeks, followed by 100mg per day for 4 weeks, if tolerated) results in a greater reduction in     hot flush score (frequency * severity) compared to placebo among women with moderate to     severe hot flashes. The secondary aim is to determine the effect of treatment with sertraline     on quality of life, sleep, sexual function, and mood.   "
186115|NCT00283205|"     The Yoga for Treatment of Hot Flashes and Menopausal Symptoms is an uncontrolled pilot     clinical trial to determine the feasibility of recruitment and of evaluating yoga for the     relief of menopausal hot flashes in 12 peri- or postmenopausal women. Participants will     attend an Introductory Yoga Workshop, 8 yoga training sessions in 8 weeks, be assessed     clinically before, during, and after training and contacted by telephone 3 months later.   "
186116|NCT00283218|"     The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin     analogues will improve post prandial glycaemic control in patients with type 1 diabetes.      OBJECTIVE:      The objective is to describe pharmacodynamic (PD) and pharmacokinetic (PK) profiles of     Insulin Aspart (IAsp), Biphasic Insulin Aspart (BIAsp) 30, 50 and 70 for a period of 12 hours     following a standard test meal on four days respectively in subjects with type 1 diabetes.   "
186117|NCT00283231|"     This is an uncontrolled pilot clinical trial to determine the feasibility of recruitment and     effectiveness of a device called RESPeRATE that paces respiration to treat menopausal hot     flashes in 12 peri- or postmenopausal women. Participants will practice paced respiration for     15 minutes everyday for six weeks and attend assessment visits at weeks 3 and 6.   "
186118|NCT00283244|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. It is not yet known whether gemcitabine and erlotinib are more effective when given     alone or together in treating non-small cell lung cancer.      PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how     well they work when given alone or together as first-line therapy in treating older patients     with stage IIIB or stage IV non-small cell lung cancer.   "
186119|NCT00283257|"     This is a multi-site randomized control trial taking place at six cancer centers. UC Davis is     the lead site. Additional performance sites include the City of Hope Medical Center, Fred     Hutchinson Cancer Center at the Univ. of Washington, USC Norris Cancer Center, UCSD Cancer     Center, and Johns Hopkins Cancer Center. Clinical trial patients and their caregivers who are     randomized to the intervention arm of the study are scheduled for three educational sessions.     The sessions focus on teaching problem solving skills based on the COPE problem solving     model.   "
186120|NCT00283270|"     The aim of the study is to test whether screening followed by brief problem-solving     counselling in primary care could improve the quality of life of elderly patients with     undiagnosed psychological problems. We hypothesize that undiagnosed psychological problems     detectable by screening are common in the elderly and brief counselling could improve the     quality of life of these patients.   "
186121|NCT00283283|"     This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu     season.   "
187139|NCT00295022|"     To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of     seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an     environmental exposure unit.   "
186122|NCT00283296|"     The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding,     ultralight manual wheelchair that incorporates small swing-down wheels for navigation in     confined areas. This enables access to narrow environments such as those encountered in     offices, restrooms, and transportation settings. When using the small access wheels, the     wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead     compartment. It is anticipated that the Endeavor will maximize mobility; increase access to     confined areas; and ease the demands of travel for people with disabilities.   "
186123|NCT00283309|"     The primary purpose is to determine if patients scheduled to receive prescription     corticosteroid therapy for inflammatory illnesses who are given either memantine or riluzole     pretreatment will show lesser declarative memory impairment than those receiving placebo.      The exploratory purpose is to determine if patients scheduled to receive prescription     corticosteroid therapy for inflammatory illnesses who are given memantine or riluzole     pretreatment will show a smaller increase in manic/hypomanic symptom severity than those     receiving placebo.   "
186141|NCT00283543|"     To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with     Temozolomide   "
186142|NCT00283556|"     The purpose of this study is to compare the response to treatment and side effects associated     with high dose irinotecan in patients with recurrent brain tumors.   "
186143|NCT00283569|"     To establish a clinic based case control study for examination of potential risk factors for     primary adult brain tumors.   "
186315|NCT00275834|"     The primary aim of this study is to assess long-term weight loss efficacy of zonisamide     relative to placebo in obese patients prescribed a dietary intervention.   "
186124|NCT00283322|"     Intensive care unit patients have multiple risk factors for venous thromboembolism. Venous     thromboembolism leads to significant morbidity and can be fatal. Unfractionated heparin and     low molecular weight heparin are commonly used to prevent venous thromboembolism. Heparin     induced thrombocytopenia, an untoward consequence of exposure to heparin, is an immune     disorder that may develop in patients treated with heparin products. Determining the     prevalence of heparin induced thrombocytopenia and its relationship to preventive and     therapeutic heparin and low molecular weight heparin will help clinicians more appropriately     choose methods of venous thromboembolism prophylaxis and treatment in the critically ill, ICU     population.      The objective of this study is to determine the prevalence of heparin-induced antibodies on     admission to the ICU and the development of new heparin-antibodies during the first week of     hospitalization.   "
186125|NCT00283335|"     This was a double-blind randomized trial comparing 1200 mg per day of gemfibrozil with     placebo in 2531 men with coronary heart disease, an HDL-C of 40mg/dl or less, an LDL-C of 140     mg/dl or less, and triglycerides of 300mg/dl or less. The primary outcome was nonfatal     myocardial infarction(MI) or death from coronary causes. The median follow-up was 5.1 years.     There was a risk reduction of 22% in the primary outcome (p=.0006) and 24% risk reduction in     the combined endpoint of stroke, MI, and CHD death. The rate of events was reduced by raising     HDL-C and lowering triglycerides without lowering LDL-C (N Engl J Med 1999;341:410-418).   "
186126|NCT00283348|"     The purpose of this study is to help researchers find out more about a condition called     Chronic Allograft Nephropathy (CAN). CAN is a complication that sometimes occurs after     kidney transplantation and affects the function of the transplanted kidney. It is hoped that     by studying blood, urine, and tissue samples of kidney transplant patients, new ways of     diagnosing and treating CAN may be found.   "
186127|NCT00283361|"     The main purpose of this study is to see if the experimental drug ZP120, when given with the     approved drug furosemide to patients with acute or sub-acute heart failure, can reduce the     amount of fluid in the patients' lungs and make breathing easier.   "
186128|NCT00283374|"     Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its     definition is still evolving. Patients with this syndrome are at increased risk for     cardiovascular disease, and at increased risk of mortality from cardiovascular disease.      Metabolic syndrome is strongly associated with obesity, and more specifically with abdominal     obesity. Abdominal obesity, comprises two main components: visceral (VAT) and subcutaneous     (SAT) adipose tissue depots, with VAT reported as more metabolically active than SAT, and     thought to play a major role in the metabolic disturbances associated with obesity and     metabolic syndrome.      Non-alcoholic fatty liver disease (NAFLD) is fast becoming the most common liver disease and     is associated with obesity, insulin resistance and metabolic syndrome.      Bariatric surgery has yielded dramatic results including longitudinal loss of excess body     weight and either complete reversal or significant improvement of several features of     metabolic syndrome, NAFLD, and nonalcoholic steatohepatitis (NASH) in obese patients.   "
186129|NCT00283387|"     The aim of this study is to assess the efficacy and safety of betaine in reducing urine     oxalate excretion of Type 1 Primary Hyperoxaluria (PHI) patients.      Hypothesis:      Betaine will effectively reduce urine oxalate excretion in Primary Hyperoxaluria Type I     patients.   "
186130|NCT00283400|"     The purpose of this study is to evaluate the tolerability and safety of 25 percent human     albumin therapy in patients with subarachnoid hemorrhage.   "
186131|NCT00283413|"     The objective of the Symbiot III Clinical Trial was to evaluate the safety and effectiveness     of the Symbiot Covered Stent System in the treatment of symptomatic ischemic saphenous vein     bypass graft disease.   "
186132|NCT00283426|"     The purpose of this study is to determine whether soluble beta-1,3/1,6-glucan is an effective     and safe treatment of thermal burns and non-injured skin where skin grafts are harvested.      Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities improve     wound healing of thermal burns and non-injured skin where skin grafts are harvested.   "
186133|NCT00283439|"     The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG     531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with     lymphoma receiving multi-cycle chemotherapy.   "
186134|NCT00283452|"     The purpose of this study is to determine whether a new phone and mail based coaching/support     program that has been developed is more effective in helping people stay physically active     than existing programs that are currently available to all HealthPartners members. We     hypothesize that the intervention program will lead to a greater likelihood of physical     activity maintenance among moderately active older adults than a usual care condition.   "
186135|NCT00283465|"     The purpose of this study is to compare the effectiveness of early treatment of anemia with     epoetin alfa (a glycoprotein that stimulates red blood cell production) or best standard     anemia care on the need for blood transfusions, tumor response, anemia and quality of life in     patients with cancer receiving platinum-containing chemotherapy.   "
186136|NCT00283478|"     To determine if Iscar Quercus improves immune function and quality of life among patients     with stage IV non-small cell lung cancer.   "
186137|NCT00283491|"     The purpose of this study is to determine the effect of a lactic acid fermented oat gruel on     iron absorption in the upper and lower part of the intestine, respectively.   "
186138|NCT00283504|"     The researcher proposes to assess levels of sputum inflammatory markers (eosinophils,     eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in     a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma     symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).      Associations will be assessed between the types of sputum inflammatory markers and the     patient's atopic status and level of asthma control as indicated by the following measures:        1. pulmonary function test (PFT)        2. asthma symptoms based on the Asthma Control Test (ACT)   "
186139|NCT00283517|"     The purpose of the study is to assess demographic, treatment, and outcome data in     schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid     formulations of first generation (conventional) or second generation (atypical) antipsychotic     medications.   "
186140|NCT00283530|"     The purpose of this study is to identify the genetic makeup of cancers, the cancer response,     and the correlation of the cancer response to standardized regimens of cancer treatment.   "
186148|NCT00283634|"     Tarceva, an orally available small molecule, has demonstrated potent activity in tumor models     and humans. This randomized, open-label phase 2 study of Tarceva alone and of Tarceva plus     VELCADE is designed primarily to determine the objective tumor response rates to these     treatments in patients with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC) that is     refractory to or has relapsed after front-line chemotherapy.   "
186149|NCT00283647|"     Exposure to lead during pregnancy, infancy, and childhood increases the individual likelihood     of impaired school performance, increased impulsiveness, aggression, and delinquent behavior.     Disorders that result from exposure to environmental neurotoxicants are a complex web of     interactions between genetic, neurochemical, biochemical, environmental and social factors     that influence children during critical periods of development. To date, research in the area     of human developmental neurotoxicology focuses primarily on global measures of sensory-motor     development and cognition. However, studies elucidating the biological basis for     developmental and behavioral disorders due to environmental toxicant exposure are lacking.     Although gross brain structure appears normal, underlying problems exist at a neural level.     Our proposal seeks to relate childhood environmental lead exposure at various levels and     stages of development with detriments in brain structure and neurochemical functioning     assessed with magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).     Cortical and subcortical brain volumes will be determined with high resolution MRI. Neuronal     and glial cell markers will be measured using proton MRS. These structural and chemical     measures will also be correlated with behavioral measures from the young adult participants     of the Cincinnati Lead Study (CLS). These participants represent a unique and ideal cohort of     approximately 240 subjects with detailed histories of exposure and behavioral outcomes in     lead exposed children monitored for approximately 20 years. A pilot study examining language,     working memory and attention in combination with functional magnetic resonance imaging (fMRI)     will also be performed to better understand the functional and behavioral deficits.   "
186150|NCT00283660|"     This study will determine whether supplements of the mineral zinc will improve mental health     and school performance among schoolchildren in Guatemala.   "
186151|NCT00283673|"     This study randomized healthy sedentary people age 20-80 years to 16 weeks of supervised     exercise versus no exercise. Several end points were evaluated after 16 weeks including     insulin sensitivity and muscle physiology.   "
186152|NCT00283686|"     The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the     progression of cystic disease and on the decline in renal function in autosomal dominant     kidney disease (ADPKD) will be assessed in two multicenter randomized clinical trials     targeting different levels of kidney function: 1) early disease defined by GFR >60     mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73     m2 (Study B; NCT01885559). Participants will be recruited and enrolled, either to Study A or     B, over the first three years. Participants enrolled in Study A will be followed for at least     5 years, while those enrolled in Study B will be followed for five-to-eight years, with the     average length of follow-up being six and a half years. The two concurrent randomized     clinical trials differ by eligibility criteria, interventions and outcomes to be studied.   "
186153|NCT00283699|"     The purpose of this study is to determine if treatment with albendazole improves the clinical     outcome of neurocysticercosis infection and/or leads to the disappearance of cysts sooner     when compared with symptomatic treatment.   "
186154|NCT00283712|"     Pemphigus vulgaris (PV) is a rare skin disorder that causes blistering of the skin and mucous     membranes. Infliximab is a man-made antibody used to treat certain types of immune system     disorders, including rheumatoid arthritis and Crohn's disease. This study will determine if     infliximab given in combination with prednisone is a safe and effective treatment for adults     with PV.   "
186155|NCT00283725|"     The purpose of this observational study is to examine patterns of treatment care for patients     with Alzheimer's disease (AD) in a real-world arena and to examine the association with     different outcomes for patients and informal caregivers.   "
186156|NCT00283738|"     The objective of the study is to investigate the safety and effectiveness of PFO closure with     the BioSTAR Septal Repair Implant System in a population of patients that have refractory     migraine (with aura) and who have failed medications.   "
186157|NCT00283751|"     This trial is conducted in Europe and the United States of America (USA). The aim of the     trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is     at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug     treatment in reducing HbA1c in patients with Type 2 Diabetes.   "
186158|NCT00283764|"     Compare the antihypertensive efficacy of two methods for instilling Xalatan eyedrops   "
186159|NCT00283777|"     The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis     of the study was to evaluate the effect of supplementing the diet of individuals with Type 2     diabetes with chromium picolinate and assessing the effect on blood glucose levels and     insulin sensitivity   "
186160|NCT00283790|"     Investigation of Psychomotor and Cognitive Residual Effects of Single Oral Doses of Zolpidem     Tartrate Extended Release 12.5 mg and Eszopiclone 3 mg Compared to Placebo in Healthy Young     Volunteers, Using Flurazepam 30 mg as an External Comparator   "
186202|NCT00284336|"     This is an open label Phase II study in elderly patients (65y or older) with early breast     cancer who are candidate for adjuvant chemotherapy. A scheme with liposomal doxorubicin     (Caelyx) and cyclophosphamide (endoxan) will be used. The aim is to study the cardiac effects     of liposomal doxorubicin with new non-invasive techniques, ie strain rate imaging, classical     echocardiography, and special blood tests measuring troponin I and BNP.   "
186203|NCT00284349|"     Comparison between immobilisation by a plaster and a rehabilitation brace for the treatment     of a fracture of the ankle   "
186204|NCT00284362|"     Comparison between arthroscopic and open surgery for hallux rigidus.   "
186205|NCT00284375|"     Systematic registration of all big toe prostheses placed in Ghent University Hospital for     analyses of global results, comparison between different types of prostheses, ...   "
186206|NCT00284388|"     Development of a non-invasive method for the determination of the position of optimal muscle     length in the different muscles of the shoulder.      Analysis of the adaptation of the muscle to a new optimal length in patients with a shoulder     prosthesis.   "
186161|NCT00283803|"     The purpose of this research study is to determine if an investigational drug called     Exisulind will extend the off-treatment period of patients receiving intermittent androgen     suppression.      There is evidence suggesting that alternating between periods of treatment and no treatment     with androgen suppressants may delay the time to develop androgen-insensitive progression and     improve overall quality of life. During intermittent androgen suppression (IAS) treatments,     men receive an LHRH agonist and antiandrogen for a fixed period of time (approximately 9     months) and then enter an off-treatment period, whose length will vary, depending on the rate     of rise in the patient's PSA. Once the PSA reaches an established threshold (1 ng/mL in men     who have had a prostatectomy or 4 ng/ml in men with an intact prostate), androgen suppression     will be re-initiated for another 9 months. These cycles of on-treatment/off-treatment will be     repeated until patient no longer responds to the androgen suppression and it is clear that     their cancer is progressing. It has been observed that off-treatment periods tend to become     shorter with each successive cycle of androgen suppression, presumably due to the emergence     of androgen-independent clones. This study proposes to look at exisulind, a pro-apoptotic     drug, which may extend the off-treatment period in patients receiving IAS.   "
186162|NCT00283816|"     Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may     increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic     state. This study is to determine whether metformin added to oral contraceptive therapy in     adolescent women with PCOS improves metabolic state.The study will also test a lifestyle     improvement program to reduce weight.   "
186163|NCT00283829|"     The purpose of this study is to test if interleukin-2, a drug that stimulates the immune     system, can be used after chemotherapy to slow the progression of your disease. We also want     to test what the best dose of interleukin-2 is that can be used safely at home.      Interleukin-2, abbreviated as IL2, is a naturally produced growth hormone for the immune     cells in our body. It stimulates the growth of the immune cells and enhances their ability to     fight infections and cancers. In people with cancer, the immune cells are typically     suppressed and became even more so after irradiation and chemotherapy treatment. By giving     you more IL2 we hope to enhance the immune system so that it can fight the cancer better,     control cancer growth and shrink the cancer.   "
186164|NCT00283842|"     The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment     of neuropathic pain associated with diabetic peripheral neuropathy.   "
186165|NCT00283855|"     The objective of this study is to determine the effects of an arthritis self-management     program and an online support community delivered via an encrypted, secure web site on     psychological well-being, pain, quality of life, global health status, and social supporting     in adults with RA.   "
186166|NCT00283868|"     The purpose of this trial is to determine if an experimental remote video camera system is an     effective way for a stroke specialist to evaluate stroke patients from a distant site.   "
186167|NCT00283881|"     This study will determine if stimulation of the stroke-injured side of the brain combined     with stimulation to the paralyzed hand can temporarily improve the sense of touch in stroke     patients.      Healthy normal volunteers and people who have had a single stroke within 3 months of entering     the study that affected one side of the brain may be eligible for this study. All     participants must be between 18 and 90 years old and must be right-handed. Candidates are     screened with a medical history, neurological examination and magnetic resonance imaging     (MRI) of the brain if one has not been done within 1 year of entering the study.      Participants undergo the following tests and procedures during four 2-day sessions over about     6 weeks:        -  Peripheral high-frequency stimulation: Small loudspeakers are taped to the fingertips          and simple tactile pulses are passed through the skin. Stimulation may be sham or real.        -  Transcranial direct current stimulation: Two small rubber electrodes are taped to the          head - one above the eye and the other on the back of the head. A current is passed          between the two electrodes. Stimulation may be sham or real.        -  MRI: The subject lies in the scanner, a metal cylinder surrounded by a magnetic field,          for about 40 minutes, lying still for up to 40 minutes at a time. An electrical          stimulation is applied to the fingers of the right and left hand in separate sessions.          Earplugs are worn to muffle the loud noises during the scanning. Functional MRI measures          blood flow changes in the brain during the performance of specific tasks.        -  Behavioral measurements:             -  Grating orientation task: The subject responds as quickly as possible to a touch               stimulus to the finger by saying whether the direction of the stimulus is vertical               or horizontal.             -  Haptic object recognition task: The subject is given five categories of unfamiliar               objects in the shape of cubes. During the task, identical objects are hidden in a               sack. With eyes closed, the subject is asked to identify and find the objects from               the sack as quickly as possible.             -  Pegboard test: The subject is asked to place several pegs into a corresponding hole               of a pegboard as soon as possible.             -  Tapping task: The subject is asked to tap a metal stick on a metal plate as quickly               as possible for 1 minute.        -  Paired-pulse transcranial magnetic stimulation: This test measures changes in brain          activity. A wire coil is held on the scalp and a brief electrical current is passed          through the coil, creating a magnetic pulse that stimulates the brain. The subject hears          a click and may fee a pulling sensation on the skin under the coil, and there may be a          twitch in the muscles of the face, arm or leg. Subjects may be asked to tense certain          muscles slightly or perform other simple actions.        -  Paired-pulse somatosensory evoked potential mapping: This test measures brain activity          in another brain area. The subject is seated in a chair with eyes closed. One electrode          is placed above the eye and two others are placed on the back of the head. A short          electrical stimulus is applied to a nerve in the wrist and brain activity is recorded          while the stimulus is applied.        -  Surface electromyography: This test measures the electrical activity of muscles.          Electrodes are filed with a conductive gel and taped to the skin.        -  Visual analog and mood scale: Subjects complete questionnaires about their attention,          fatigue and mood.   "
186168|NCT00283894|"     This study will measure energy expenditure (the rate at which the body burns calories),     physical activity and caloric intake in people with narcolepsy to learn more about how the     risk of becoming overweight or diabetic may be affected.      Healthy control subjects and people with narcolepsy between 18 and 55 years of age may be     eligible for this study. Participants are withdrawn from their narcolepsy medication and     undergo the following tests and procedures over 5 weeks before resuming medications.        -  Blood draw for genetic studies.        -  Collection of a cerebrospinal fluid sample.        -  Diet to keep subjects' weight constant.        -  Activity watch, using a device worn on the wrist to measure amount of movement, and an          activity monitor worn at the waist to measure physical activity and caloric expenditure.        -  Questionnaires about sleepiness, symptoms, food intake, exercise and mood.        -  24-hour urine collection and 24-hour blood draw to measure hormones.        -  Glucose tolerance test. The subject drinks a sugar solution and blood samples are          collected through a catheter before drinking the solution and 30 minutes, 1, 2 and 3          hours after drinking it.        -  Startle reflex test. Subjects hear a loud noise through headphones and are asked to look          at pictures.        -  Sleep study to evaluate sleep-related breathing disturbances and record information          about sleep stages.        -  Indirect calorimetry test to measure how fast the body uses calories. A plastic canopy          is placed over the face for several minutes to capture the air exhaled to analyze oxygen          use. To measure the energy associated with meals, the same measurements are taken after          the subject eats lunch.        -  CT scan of the abdomen to see how much fat is deposited in the abdomen, and DEXA scan of          the whole body to see the percentage of fat and muscle.        -  Plethysmography. Participants sit in an enclosed chamber while the mass and volume of          the body are measured by changes in air pressure.        -  Neuropsychological testing to assess thought processes.        -  Continuous 24-hour heart rate measurement.        -  Metabolic chamber. Subjects spend 24 hours in a small room to measure the amount of          oxygen inhaled and carbon dioxide exhaled.        -  Walking/running test to assess level of physical conditioning.        -  Dexamethasone CRH (corticotropin-releasing hormone) suppression test and CRH stimulation          test. Subjects receive eight doses of 0.5 mg dexamethasone every 6 hours for a day and a          half. After the last dose, two blood samples are drawn, then a dose of CRH is injected,          and then six more blood samples are drawn over the next 3 hours.        -  TRH (thyrotropin-releasing hormone) stimulation test. Subjects are given TRH through a          vein, and several blood samples are then drawn over the next 3 hours.        -  Doubly labeled water test. Subjects drink a dose of heavy water. Urine samples are          collected at 2, 3 and 5 hours after drinking and again for two 4-hour collections a week          later.   "
186169|NCT00283907|"     This study of healthy normal volunteers will examine the brain networks involved in people's     sense that they control their own movements (sense of agency). Although almost everyone has a     sense of agency, some patients (for example, patients with schizophrenia, alien limb     phenomena, and others) have movements they think are not under their control. This study will     use electroencephalography (EEG) to determine how the normal brain produces the sense of     agency. This information will provide a first step in understanding patients with an impaired     sense of agency.      Healthy, right-handed men and women 18 years of age and older may be eligible for this study.     Candidates are screened with a medical history and neurological examination.      Participants are fitted with a cyberglove device (a lightweight glove with flexible sensors     that measure the position and movement of the fingers and wrist) on their right hand. The     glove is used to transform the subject's hand and finger motions into real-time digital     joint-angle information. Subjects slowly open and close their hand while watching an     artificial hand projected on a monitor. They continue practicing the exercise until they are     comfortable with the cyberglove and have the sense that the artificial hand is a mirror     representation of their own hand, accurately reflecting their hand's movements.      After practicing with the cyberglove, subjects have a functional EEG. For this test,     electrodes are placed on the scalp, and brain waves are recorded while the subject opens and     closes his or her hand or just watches the computer monitor. The EEG recording takes about 60     minutes.   "
186207|NCT00284401|"     Comparison of the function and mobility of the shoulder with the placement of the Delta     prosthesis (anteversion and retroversion of the glenoidal and humeral components)   "
186231|NCT00284726|"     The purpose of this study is to compare 2 different cold storage solutions, used to preserve     donor lungs for lung transplantation, and their effect on cytokine activation related to     ischemic reperfusion injury. Primary endpoint is 30 day survival.   "
186170|NCT00283920|"     This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI)     to measure peripheral benzodiazepine receptors (PBRs) in the brain. PBRs were initially found     in peripheral organs such as kidneys, endocrine glands and lungs, but later studies     identified PBRs in the CNS. PBRs can be a marker to detect nervous system inflammation.     Development of a test to image PBRs may improve the management of brain disorders such as     multiple sclerosis, Alzheimer's disease, Parkinson's disease, and others in which     inflammation is involved in progression of the disease.      Healthy volunteers from 18 to 40 years old may be eligible for this study. Candidates are     screened with tests that may include some or all of the following: diagnostic interview;     ratings of mood, anxiety, functioning, and other parameters; neuropsychological testing;     physical examination; electrocardiogram; blood and urine tests; and personal, social and     family histories.      Participants undergo the following procedures:        -  Evaluation: Subjects provide a medical history, including detailed questions about their          psychological health, and have a physical examination and blood and urine tests.        -  PET scanning: PET uses small amounts of a radioactive chemical called a tracer that          labels active areas of the brain. The tracer used in this study is [11C]PBR28. For the          procedure, the subject lies on the scanner bed. A special mask is fitted to the head and          attached to the bed to help keep the head still during the scan so the images will be          clear. A brief scan is done just before the radioactive tracer is injected to provide          measures of the brain that will help to precisely calculate information from subsequent          scans. After the tracer is injected through a catheter (plastic tube) placed in the arm,          pictures are taken for 2 to 3 hours, during which the subject lies still on the scanner          bed. Subjects return to the clinic the following day for more blood and urine sample          collections.        -  MRI: The MRI scan is done within 1 year of the PET scan (either before or after the          PET). MRI uses magnetic fields and radio waves to produce images of the brain. The          patient lies on a table that is moved into the scanner (a narrow cylinder), wearing          earplugs to muffle loud knocking and thumping sounds that occur during the scanning          process. He or she can communicate with the staff at all times during the procedure.   "
186171|NCT00283933|"     The purpose of this study is to collect information on the safety of AT1001 (migalastat     hydrochloride) and how AT1001 works in patients with Fabry disease.   "
186172|NCT00283946|"     The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR     Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using     zolpidem (Myslee) as a comparative drug   "
186173|NCT00283959|"     The purpose of this study is to collect information on the safety of AT1001 (migalastat     hydrochloride) and how AT1001 works in patients with Fabry disease.   "
186174|NCT00283972|"     To prospectively observe the association of the LAP-BAND procedure on quality of life,     anthropometric, metabolic and biochemical parameters in morbidly obese patients when     performed by experienced US surgeons. The study will also include a complete economic     analysis of the LAP-BAND procedure and follow-up costs Hypothesis: Measurements defining     quality of life and the severity of obesity and obesity related comorbidities improve     significantly over baseline with the LAP-BAND System treatment at 6 and 12 months post     surgery when performed by an experienced surgeon.   "
186175|NCT00283985|"     Nasal/nasal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin's lymphoma (NHL)     more frequent in Asia than in western countries. When localised, radiotherapy seems to be the     best treatment. When radiotherapy cannot be used because of dissemination or relapse,     chemotherapy protocols used for other types of NHL give poor results and survival is poor.     Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually     used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours     by l-asparaginase was shown on tumour cell lines and samples.      The investigators propose a phase II protocol for patients with refractory or relapsing     nasal/nasal type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate     and dexamethasone. Biological studies will be conducted trying to find factors which could     predict responses to this chemotherapy.      Since january 2009, the study concerns all patients with nasal/nasal type NK-T-cell lymphoma     who have not received asparaginase before.   "
186176|NCT00283998|"     The purpose of this study is to compare the safety and effectiveness of surgical versus     conservative management of type II odontoid fractures among patients >/= 65 years of age. Of     secondary interest is to determine if there are differences in outcomes between anterior     screw fixation and posterior fusion of these fractures.   "
186177|NCT00284011|"     The purpose of this study is to determine if the oral intake of the dietary supplement SAMe     increases blood homocysteine levels in healthy human subjects.   "
186178|NCT00284024|"     This study is testing if a medication called domperidone will help women produce more milk so     that they can keep breastfeeding and not use formula. The study is also testing what dose of     domperidone works best to increase breast milk production.   "
186179|NCT00284037|"     Individuals with obstructive sleep apnea syndrome (OSAS) are at high risk for cardiovascular     morbidity and mortality. The effect of long-term nocturnal therapy with continuous positive     airway pressure (CPAP) on daytime baroreflex sensitivity (BRS), a predictor of cardiac death,     was investigated in OSAS patients.   "
186180|NCT00284050|"     This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual     acuity in patients with diabetic macular edema with center involvement.   "
186181|NCT00284063|"     The purpose of this continuation project is to use MRI to evaluate gapping of the     zygapophysial (Z) joints following side-posture positioning and side-posture spinal adjusting     in subjects with acute low back pain.   "
186183|NCT00284089|"     Open-label Multicenter, Phase I/II Study comprising three phases (single dose, multiple dose     and extension phase), Assessing the Safety and Efficacy of Ranibizumab (RFB002) in Japanese     Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular     Degeneration (AMD).   "
186184|NCT00284102|"     The investigators aim to study the effect of different levels of PEEP in ALI/ARDS patients on     gas exchange.   "
186185|NCT00284115|"     Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive     approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer     enabling nonambulatory patients to have the repetitive practice of a gait-like movement.   "
186186|NCT00284128|"     The primary objective is to assess the antihypertensive efficacy of 4 different AVE 7688     doses on the change from baseline in trough diastolic blood pressure at the end of week 12.      The secondary objectives are:        -  To assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from          baseline in trough systolic blood pressure at the end of week 12        -  To compare the percentages of responders after 12 week of treatment        -  To evaluate the long term safety and tolerability of AVE 7688 with particular attention          to angioedema   "
186232|NCT00284739|"     Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will     reduce the duration of percutaneous drainage and increase the proportion of successful     drainages.   "
186187|NCT00284141|"     This study evaluated the efficacy and safety of aflibercept in the treatment of participants     with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA).      Primary objective:        -  To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept,          aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in          participants with platinum- and erlotinib-resistant, locally advanced or metastatic          NSCLA.      Secondary objective:        -  To assess duration of response (DR), progression-free survival (PFS), and overall          survival (OS) in this participant population        -  To evaluate the safety profile of IV AVE0005 (ziv-aflibercept, aflibercept, VEGF trap,          ZALTRAP®).      This study employed an Independent Review Committee (IRC) for radiological tumor assessments.     For all tumor assessment-related efficacy variables, two analyses were performed: the primary     analysis was based on Independent Review Committee (IRC) reviewed data and the secondary     analysis was based on Investigator evaluation.      In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response     Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST     criteria only consider the longest diameter of the tumors for calculations pertaining to     changes in tumor size, mRECIST assessments also account for the differences in the cavities     of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and     mRECIST are reported.   "
186188|NCT00284154|"     This clinical trial involves the administration of the chemotherapeutic medication     vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of     extensive small cell lung cancer. The purpose of this research trial is to study the     effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer,     evaluate the toxicity, and evaluate how long the response to this drug lasts.   "
186189|NCT00284167|"     The primary objective of this study is to assess the benefit of using online, tailored     behavioral weight management materials (Balance), in combination with nutritional materials     (Balance and Nourish), in conjunction with a goal setting tool (Balance and Achieve), or a     combination of all three (Balance, Nourish and Achieve). This objective will be evaluated by     measuring weight loss rates as reported by study participants at 3, 12, and 18 months     post-enrollment. The hypothesis is that adding additional materials will increase the effect     of the intervention over just using Balance alone.   "
186190|NCT00284180|"     This research study involves the anti-cancer medication trastuzumab and the investigational     drug vinflunine. The purpose of this trials is to see if trastuzumab and vinflunine used in     combination or vinflunine alone is effective in the treatment of metastatic breast cancer   "
186191|NCT00284193|"     Patients with severe hemophilia and inhibitors can be treated effectively by Activated     Prothrombin Complex Concentrates (APCC, eg. FEIBA) or High dose recombinant factor VIIa     (rFVIIa). Rarely, such patients develop refractoriness to these products for whom therapy     with sequential FEIBA and rFVIIa has been recently suggested.      The impetus for the present report was a hemophilia A patient with high titer inhibitor     (1300BU) who had life threatening hematuria that was resistant to repeated doses of 400µg/kg     rFVIIa up to a cumulative dose of 1200 µg/kg given over 6-9 hours.      Thrombin generation (TG) tested in vitro was consistent with resistance to high     concentrations of rFVIIa but yielded good response to combinations of low doses of     rFVIIa+FEIBA. In a desperate attempt to control the bleeding, concomitant therapy of 25 U/kg     FEIBA and 40µg/kg rFVIIa was infused and resulted in arrest of bleeding within minutes. Over     a span of about one year the patient has been successfully treated by this combination for     more than 200 bleeding episodes in muscles and joints.   "
186192|NCT00284206|"     Objective of the Project.      -Methamphetamine (MA) use is growing to epidemic proportions and existing treatments for MA     dependence demonstrate sub-optimal efficacy. Research implicates heavy use of MA as at least     a contributing agent to a variety of neuropsychiatric impairments including psychosis, mood     disturbance, anxiety, cognitive deficits, and motor dysfunction. Initial study by this     investigator suggests that agents like risperidone may also be beneficial to MA dependent     individuals by decreasing MA use and improving cognitive function in early abstinence.     Long-acting injectable risperidone may prove more efficacious given its receptor binding     characteristics and potential to increase medication adherence. The study objective is to     determine the safety and efficacy of treating MA dependence and the associated cognitive and     psychiatric symptomatology with long-acting injectable risperidone.   "
186193|NCT00284219|"     Cigarette smoking is a major public health problem causing significant morbidity and     mortality. Yet, smoking cessation therapies are often ineffective at helping smokers break     their addiction.      The mesolimbic dopaminergic reward system plays a crucial role in mediating the reinforcing     effects of nicotine. Recently, acute high frequency repetitive transcranial magnetic     stimulation (rTMS) of frontal brain regions has been shown to efficiently modulate the     mesolimbic dopamine systems in both animals and humans. For this reason, we investigated     whether 10 high-frequency (10Hz) rTMS treatments over the left dorsolateral prefrontal cortex     can help people to withdraw smoking in comparison to placebo rTMS.      Smokers seeking to quit are recruited through newspaper advertisements. Participants were     randomized to 10 days of either real or placebo high frequency rTMS.   "
186194|NCT00284232|"     A randomized controlled trial in patients with type 1 diabetes, assessing the metabolic     effects of accurate blood sugar results and education. A systematic approach in     self-monitoring blood glucose will improve metabolic control in type 1 diabetes patients.     Education in SMBG combined with a high analytical quality instrument for SMBG, introduced in     a systematic and thorough way will improve HbA1c by 0,5% and keep it over a period of 9     months.   "
186195|NCT00284245|"     In earlier work, the Sponsor developed a computer image processing system for analysis of     pain diagrams from patients with chronic pain. This system was then tested in a study in over     500 chronic pain patients seen by both primary care practitioners and pain specialists. The     hypothesis was that pain location would correlate with the pain type and the underlying cause     of the pain. In the study, the computer analysis demonstrated clear correlations between pain     diagram data and diagnosis/pain type. The present study extends these observations in a     web-based setting, with a focus on the value of computer analysis of pain diagrams as     diagnostic predictors.   "
186196|NCT00284258|"     This study is designed as Phase II/III. Phase II is aimed to evaluate safety and efficacy of     IRIS, and feasibility of FOLFIRI. Phase III is aimed to verify inferiority of the progression     free survival of IRIS in comparison with FOLFIRI.   "
186209|NCT00284427|"     It is known that people with cancer are using antioxidant vitamins at high rates. It is not     known if these vitamins are safe to use during cancer treatment. It is not known if common     vitamins and minerals used by many cancer patients will interfere with cancer treatments by     reducing the effectiveness of the cancer therapy. Preliminary studies that look at the     addition of antioxidants during cancer therapy show us that antioxidants could play a     significant role in the management of cancer.      Antioxidants are vitamins and other nutrients that help to decrease inflammation in the body     by stopping free radicals or oxidants. Common antioxidants include vitamins E, C, and A,     beta-carotene, and glutathione. Some doctors who treat cancer are now using antioxidants with     chemotherapy while others believe they should not be used with cancer treatment.      The purpose of this study is to try and understand if it is safe efficacious to add     antioxidant nutritional supplements to traditional chemotherapy and/or radiation therapy     during the treatment of cancer.   "
186210|NCT00284440|"     The present study is designed to compare the response of choroidal blood flow to the     hand-grip test in glaucoma patients with and without visual field progression.   "
186211|NCT00284453|"     The purpose of the proposed pilot study is to identify factors which are associated with     periods of high ventricular arrhythmia burden. This will be performed by analysis of gene     expression from peripheral blood samples.   "
186212|NCT00284466|"     The purpose of the study is to compare the pictures of heart arteries obtained by MSCT     scanner to the pictures obtained during heart catheterization. Our specific question is     whether the MSCT scanner is accurate enough to replace heart catheterization in some     situations for the evaluation of coronary heart disease.   "
186213|NCT00284479|"     The purpose of this study was to investigate the effects of an 8 week program of walking for     45 minutes, twice a week, on fitness, body composition , blood pressure and blood markers of     cardiovascular risk. We hypothesised that this 90 minutes of walking per week would result in     measurable increases in fitness and reductions in body fat, resting blood pressure and     improved blood lipid profiles.   "
186214|NCT00284492|"     In a pragmatic study investigate whether Traditional Chinese Medicine acupuncture-care     decreases the frequency of hot flushes and increases health related quality of life among     postmenopausal women. The intervention group will receive 10 sessions of acupuncture, the     control group will engage in self care only. The study period lasts for 12 weeks.   "
186215|NCT00284505|"     This pilot study will evaluate whether thalidomide decreases pain in patients with     arachnoiditis.   "
186216|NCT00284518|"     The purpose of this study was to determine the safety and effectiveness of different doses of     botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic     hyperplasia.   "
186217|NCT00284531|"     This protocol is designed to obtain information on the drug levels, metabolism, and safety of     daclizumab (Zenapax(R)) in children and adolescents undergoing cardiac transplantation. In     addition to the drug safety and metabolism information, the number and severity of rejection     episodes in patients undergoing cardiac transplantation using the standard immunosuppressive     drugs plus daclizumab will be compared with patients who have previously undergone cardiac     transplantation at the Baylor College of Medicine and received the same standard     immunosuppressive drugs without daclizumab.   "
186218|NCT00284557|"     The purpose of this study is to determine whether participation in a group-based health     education curriculum is superior to receipt of standardized health educational materials for     children who are overweight or at risk for overweight with regard to achievement of a     healthier body weight and improvement of key eating and physical activity behaviors.   "
186219|NCT00284570|"     First, we, the researchers, hope to find out the PCT response to heart surgery in children by     taking blood before surgery and each day for four days after surgery. These blood draws will     help us figure out the typical Procalcitonin (PCT) response, the normal increase in PCT after     heart surgery, and when the PCT level returns to baseline.      Second, we, the researchers, hope to determine the accuracy of PCT as a marker of infection.      Hypothesis      Our hypothesis is that Procalcitonin is superior to other currently used markers of infection     and will prove to be a clinically useful tool for evaluation of infection in children     following cardiac surgery.   "
186220|NCT00284583|"     Interdigital neuroma is a painful forefoot disorder characterized by plantar pain and toe     paresthesias thought to result from entrapment of the interdigital nerve by the overlying     transverse metatarsal ligament. Multiple treatments have been recommended for this condition     and range from modification of shoe wear to surgical excision of the painful nerve. Serial     ethanol injection therapy has been reported to be an effective alternative to surgical     excision. However, despite wide adoption of this treatment, no randomized, double blinded,     placebo-controlled study exists to verify the efficacy of this treatment in comparison to     longer standing similar therapies, such as corticosteroid injection.      120 patients from one Orthopaedic group’s foot and ankle offices with single foot neuromas     and no previous history of neuroma or foot disorder treatment will be selected for the study.     These patients will be randomized to three treatments, specifically lidocaine injection,     corticosteroid injection, or ethanol injection. Outcomes will be assessed at 3, 6 and 12     month time points using validated questionnaires as well as a non-validated disease specific     questionnaire. Primary endpoint will be graded change in the physical function portion of the     SF-36 form. Secondary endpoints will be the graded change in the McGill Short Form for Pain     and ultimate satisfaction with treatment as assessed by a non-validated questionnaire     designed for Morton’s neuroma symptoms.   "
186233|NCT00284752|"     Evaluate the efficacy of Abraxane in first line chemotherapy of patients with hormone     refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response   "
186234|NCT00284765|"     The purpose of this trial is to study the management of the sprained ankle by help of     NSAID-plaster. A questionnaire. The effect of RICE and RICE + NSAID-plaster in the treatment     of the sprained ankle, compared by pain-score.   "
186250|NCT00284973|"     Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate,     PfCP2.9 adjuvanted with Montanide ISA 720. This trial is designed to test the safety and     immunogenicity of 3 doses and 2 vaccination schedules.      This blood stage candidate malaria vaccine is being developed for the routine immunization of     infants and children living in malaria-endemic areas.   "
186221|NCT00284596|"     Patients undergoing opening wedge high tibial osteotomy (HTO) will be randomized to standard     or locking screw fixation of the osteotomy plate. Tantalum beads will be implanted around the     osteotomy site in all subjects to facilitate RSA imaging which will then allow micromotion at     the osteotomy site to be quantified.      Primary Objectives and Hypothesis        1. a)to determine fixation stability of the Puddu opening wedge osteotomy plate secured          with non-locking compared to locking screws. We hypothesize that plate fixation with          locking screws will result in a significant reduction of micromotion between tibial          segments prior to bony healing compared to the non-locking screw fixation.           b)To determine the progress of bony healing. We hypothesize that increased fixation          stability in patients with locking screws will facilitate early bone healing reflected          by smaller micromotion over time compared to the non-locking screw patients.        2. a)If there is improved stability with the use of locking screws, rehabilitation          protocols following opening wedge HTO will be modified accordingly. We hypothesize that          decreasing micromotion will reach the detection limit of the RSA setup (0.4 mm) earlier          in the locking screw group than in the non-locking screw group.           b)To evaluate the effect of the osteotomy on proximal tibial anatomy. We hypothesize          that an open-wedge procedure might increase rather than decrease the tibial slope.   "
186222|NCT00284609|"     The aim of this study is to investigate the effect of a new rehabilitation program of type 2     diabetes patients in a primary care center versus standard care in the outpatient Hospital     Clinic.   "
186223|NCT00284622|"     It remains unknown if a concomitant arthroscopic knee debridement would increase the benefits     of surgery (quality of life and functional ability) for young active patients with medial     compartment OA of the knee and varus alignmen. This additional procedure has a low incidence     of morbidity and would potentially allow for treatment of meniscal tears and articular     damage, as well as joint lavage to remove debris and inflammatory factors. A trial is needed     to determine whether HTO with concomitant knee arthroscopy will result in better overall     outcomes for this patient group.The objective is to compare the quality of life, functional     status, pain, and swelling of patients who undergo an HTO with or without a concomitant knee     joint arthroscopy to address additional joint pathology   "
186224|NCT00284635|"     The purpose of this study is to see if it is possible to discharge patient undergoing a UKA 1     day postoperatively   "
186225|NCT00284648|"     This study is intended to determine whether the optimal treatment of acute Achilles tendon     ruptures is surgical repair or functional bracing.      Our hypotheses are surgical repair will: 1) Result in a clinically relevant decrease in     re-rupture rate and 2) Result in a clinically relevant improvement in disease specific     quality of life and 3) A clinically relevant improvement in functional outcome measures   "
186240|NCT00284843|"     The purpose of this study is to estimate the number of cases of rheumatic heart disease,     pyoderma, and scabies in school age children in Fiji. In addition the study will describe the     features of rheumatic heart disease, pyoderma, and scabies in these children. Study     participants will include 5200 primary school children, ages 5-14, from 21 primary schools in     the Central Division of Fiji. These children will be examined for pyoderma, scabies, and the     doctor will listen to their heart with a stethoscope. Any child that has a heart murmur     detected will have their heart looked at through an echocardiogram test (uses sound waves to     create a picture of how the heart is working). Any child that is found to have rheumatic     heart disease will be referred to a pediatric cardiologist for further evaluation.     Participants will be involved in the study for about 2 days.   "
186226|NCT00284661|"     Meniscal repair resulting in meniscal preservation is the most desirable treatment of a torn     meniscus and is one of the most commonly performed arthroscopic procedures. The inside-out     meniscal suturing technique allows precise placement of sutures under direct visualization     and studies have reported excellent healing rates and low re-tear rates. However,     complications associated with the use of the inside-out technique (injury to the knee's     neurovascular structures and infection) and the fact that it is a time consuming procedure     have generated the development of alternative methods and devices. The FasT-Fix is reported     to be quicker and safer. It is applicable to tears in most locations and requires no     additional incisions or portals. Even though this and many similar devices are widely used     with reported clinical healing rates of 75 -92% and relatively minor complications, few     prospective, randomized clinical trials evaluating and comparing different techniques have     been carried out. Patient outcome studies are necessary to evaluate which technique     ultimately results in the most effective repair and the least patient disability following     surgery.      We hypothesize that an inside-out suturing technique will have a higher complication rate but     a significantly lower failure rate than the FasT-Fix Menisical Repair System   "
186227|NCT00284674|"     This evaluation is being conducted to evaluate the performance of thee prosthesis.   "
186228|NCT00284687|"     Human cytomegalovirus (HCMV) has remained a major cause of morbidity and mortality following     allogeneic bone marrow or peripheral blood stem cell transplantation (SCT). The most reliable     virological predictive marker for disease development is the presence of HCMV viremia. It has     been further recognized that viral load, and viral load kinetics are important determinants     of pathogenesis. Prior to the preventive use of antiviral agents, CMV disease occurred in     15-45% of at-risk patients and carried a high mortality rate. In the last decade, major     advances in the prevention of CMV disease have occurred with the application of pp65     antigenemia and qualitative/quantitative polymerase chain reaction (PCR) assays for the rapid     and sensitive diagnosis of HCMV infection, combined with preemptive antiviral treatment     targeted to patients with viremia. The prevalence of early CMV disease has declined to 3% to     6% with intense antiviral drug use. All antiviral drugs currently used for the treatment of     systemic HCMV infection, including ganciclovir, foscarnet, and cidofovir, target the HCMV DNA     polymerase. Ganciclovir is the most widely used drug for preemptive treatment. However,     ganciclovir treatment is often complicated by bone marrow toxicity with the occasional     development of potentially life-threatening thrombocytopenia, granulocytopenia, and graft     failure, associated with secondary bacterial and fungal infection. Another limitation of     preemptive ganciclovir therapy is the requirement for intravenous administration. The     currently available oral valganciclovir is not yet approved for preemptive therapy in SCT     recipients, and is associated with high treatment cost. Additionally, prolonged or repeated     ganciclovir treatment may lead to the development of drug resistance. The use of foscarnet     and cidofovir is limited by considerable nephrotoxicity, low oral bioavailability, and high     cost. Thus, there is an increasing need for new effective non-toxic, low-cost anti-HCMV drugs     with high oral bioavailability.      Recently, the anti-malaria drug artesunate, which is widely used in the treatment of severe     malaria, has been shown to be a highly effective inhibitor of HCMV in vitro. Artesunate     exhibited similar antiviral activity (same micromolar range) to that of ganciclovir, while     demonstrating no cytotoxicity. Importantly, its antiviral activity has been further     demonstrated in vivo in a rat CMV model. No significant side effects were demonstrated in a     number of pre-clinical and clinical studies, and artemisinin and its derivatives have been     shown to be well-tolerated and safe in adults and children. Several million people have taken     artemisinins to date, with no significant adverse or treatment-limiting effects being     reported. Although neurotoxicity has been reported with supraphysiological doses in animals,     it has not been documented in humans. Meta-analyses of malaria patients treated with     artemisinins demonstrated that this drug class is safe. In rare cases, however, slight     changes to haematology values have been seen, including a reduction in the number of     reticulocytes as well as a slight increase in transaminase levels. These signs, however, do     not generally give rise to any noticeable clinical manifestations. In rare cases, a slight     but transient reduction in sinus heart rate has been observed. Abdominal cramps and mild     diarrhoea have been reported at elevated doses.      Thus, one might expect a similarly high degree of safety for the potential use of artesunate     as an antiviral drug for HCMV infection. Thus, oral therapy with artesunate could be a     beneficial option to the current therapies for the preemptive treatment of HCMV disease in     SCT recipients.   "
186229|NCT00284700|"     Helicobacter pylori is recognized as a major gastrointestinal pathogen in developing     countries. This microorganism infects up to 60% of children less than five years in those     countries and is strongly associated with chronic gastritis and peptic ulcer disease in     children and adults. The progression of gastritis to atrophy often leads to decreased gastric     acid output, which is a well-known risk factor for anemia. Gastric acid is essential for     increasing the bioavailability and absorption of non-heme dietary iron, the most important     source of iron in developing countries. Numerous reports suggest that iron malabsorption     secondary to low gastric acid output is a problem in developing world countries. It has been     further observed that iron deficiency anemia is resistant to iron therapy particularly in     these countries. In a recently completed study we observed an association of anaemia with H.     pylori infection. We hypothesize that the poor bioavailability of iron in these countries     could be related to H. pylori -induced low gastric acid output and we propose to investigate     the role of H. pylori infection as a cause of anemia and treatment failure of iron     supplementation in Bangladesh. A prospective, randomized, double-blind, placebo-controlled     field trial is proposed among four groups ( 65 each) of H. Pylori infected children of 2-5     years of age with iron deficiency anemia. The children will be assigned to one of the four     therapies: antibiotics alone (for H. Pylori eradication), antibiotic plus iron therapy, iron     therapy alone, or placebo. Hemoglobin concentration, serum ferritin concentration, and     transferrin receptor will be measured before and at 1 and 3 month after the intervention. We     also propose a complementary study in an additional 20 children with H. Pylori infection and     iron deficiency anemia to assess iron absorption with application of double stable isotopes.     The change in hematological parameters will also be compared among the groups before and     after the therapy. The results of this study are expected to have implications in the     prevention and treatment of iron deficiency anemia in developing countries.   "
186230|NCT00284713|"     Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with     non ischemic dilated cardiomyopathy.   "
186249|NCT00284960|"     Determine if men with erectile dysfunction (ED) are more likely to have insulin resistance     compared to healthy controls.   "
186235|NCT00284778|"     The indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer     is now well established. The two treatments of reference are pemetrexed (alimta) and     docetaxel (taxotere). Effectiveness and toxicity of the two drugs are largely documented in     the literature.      Economic analyses are currently one of the criteria used in medical decision, beside     effectiveness, quality of life and toxicities.      However, Economical comparison shows significant variations in the acquisition costs of the     two drugs. Consequently, it appears interesting to carry out a randomized prospective study     with on exclusive economical criteria of judgment.      As there is no difference in the effectiveness between the two treatments, a     cost-minimization analysis will be carried out to appreciate the ratio benefit/risks from an     economical point of view (payer).   "
186236|NCT00284791|"     The primary hypothesis of this study is that in fluoxetine (Prozac)-resistant adolescents     with Major Depressive Disorder (MDD), Lamotrigine plus fluoxetine will be safe and as     effective as sertraline (Zoloft).      Our Primary Aim is to determine the efficacy and safety of Lamotrigine-augmentation of     fluoxetine for treatment-resistant depression in adolescents.      Our Secondary Aims are to characterize the factors associated with treatment-resistance for     adolescents with major depression. Also to assess the relationships in the families of     adolescents with major depression as they enter treatment, and to track the differences in     family relationships for adolescents who respond or do not respond. We postulate that tense,     frustrated, irritable, and over-involved relationships constitute a risk factor for     attenuated improvement or relapse.   "
186237|NCT00284804|"     This study is designed to determine the objective response rate in patients with relapsed or     refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or     gemcitabine alone.   "
186238|NCT00284817|"     - Assess the safety and tolerance of a weekly MEDI522 regimen in patients with     irinotecan-refractory advanced CRC or other solid tumors refractory to standard therapy.   "
186239|NCT00284830|"     SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main     objective to study the effect of unnecessary right ventricular apical pacing on the clinical     outcome of time to development of persistent AF.   "
186241|NCT00284856|"     This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in     participants with chronic asthma who actively smoke cigarettes.   "
186242|NCT00284869|"     The purpose of this study is to investigate putative ethnic differences in the     proinflammatory response in human endotoxemia.   "
186493|NCT00287729|"     The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403     milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis     (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared     with placebo in patients with idiopathic pulmonary fibrosis.   "
186243|NCT00284882|"     The purpose of this study is to find out how often group A Streptococcus (GAS) occurs in     school-age children of Central Fiji. This bacterium often causes pharyngitis (sore throat)     and can also cause pyoderma (skin infection) or scabies. Approximately 1000 children ages     5-14 years will be enrolled from 4 primary schools in Central Fiji. These children will have     throat swabs performed to determine how commonly GAS occurs. Over the next 10 months,     children in this group who complain of sore throat will be examined and have throat swabs to     determine if GAS is the cause. A subset of 600 children will be examined for pyoderma and     scabies and have throat swabs every 2 months during the 10 month study. In addition, a small     amount of blood will be drawn at 0, 6, and 10 months to determine the level of antibodies to     Streptococcus.   "
186244|NCT00284895|"     This research study is looking at the effects of weight loss, due to surgery or structured     weight-loss program on lung function, inflammation in your body and lungs, asthma and asthma     symptoms. This study is important because we will be better able to understand the effect of     weight on lung functioning and asthma. Approximately 20 research subjects will be enrolling     in this study at National Jewish.      Adults with asthma who has elected to undergo weight-reduction surgery may qualify for the     participation. Involvement will last about 1 year.   "
186245|NCT00284908|"     S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a     class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially     available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers,     erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study     evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid     suppression is considered to be correlated with clinical efficacy.      In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each     volunteer. First, one of the dosages will be orally administered for five days. Then, a nine     to sixteen day period without study drug administration will follow prior to the     administration of the next dosage, for again five days. Each volunteer will have a total of     four study drug administration periods.      After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be     done for four days. After the last study drug intake in period 4 pharmacokinetic blood     sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood     draws over a pre-determined time period. The pharmacokinetic blood sampling measures the     medication concentration in the blood at pre-defined time points.      After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured     for 24 hours by means of a thin tube that will be inserted into the stomach through the     nostril to evaluate the efficacy of the different dosages of STU-Na.   "
186246|NCT00284921|"     To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the     clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison     with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests     (ALT/AST) after 12 months treatment.   "
186247|NCT00284934|"     This study introduces a new optimization immunosuppressive regimen associating tacrolimus at     a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow     down renal function worsening and to prevent the progression of chronic allograft     nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.   "
186248|NCT00284947|"     The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney     transplantation is associated with renal dysfunction and hypertension. The study will     evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab     at monthly doses.   "
186251|NCT00284986|"     This study is designed to evaluate the safety and efficacy of Prochymal(TM) (Ex-vivo Cultured     Adult Human Mesenchymal Stem Cells) in subjects experiencing treatment-refractory acute GVHD,     Grades III-IV, that is refractory to standard first line therapies and at least one     second-line therapy.   "
186252|NCT00284999|"     To determine the ocular efficacy and safety of Soothe and Refresh Tears.   "
186253|NCT00285012|"     This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette     smokers with the intent of demonstrating differences in smoking cessation between varenicline     and placebo.   "
186254|NCT00285025|"     The primary objective is to demonstrate that SR57667B at the dose of 4 mg/day, in comparison     to placebo, decreases the decline in cognitive performance and the global clinical decline     over 1 year in patients with mild to moderate AD.      Secondary objectives are to assess the effect of SR57667B on functional decline and its     safety/tolerability in patients with mild to moderate AD, and to document plasma     concentrations of SR57667 in patients with mild to moderate AD.   "
186255|NCT00285038|"     The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT     detected by Doppler ultrasound in a selected group of patients suffering from gynecological     malignancies.   "
186256|NCT00285051|"     Patients will be treated for 2 consecutive chemo cycles with the study drug for one and     placebo for the other. In addition, patients will receive an injection before the chemo,     either ondansetron (if receiving placebo inhalation) or normal saline) if receiving active     study drug. They will take study medication for 3 days, 4 times daily and fill out VAS scores     before and after doses. Patients will be given rescue medication with each dose.   "
186257|NCT00285064|"     To perform a comprehensive evaluation of multidetector CT myocardial enhancement patterns in     patients with an acute ST elevation MI. In particular we plan to assess the relationship     between regions with early hypoperfusion and/or late hyperenhancement, and myocardial     viability.   "
186258|NCT00285077|"     The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B     in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD).      A secondary objective is to describe the long term progression of Alzheimer's symptoms in     patients treated by 4 mg/day of SR57667B.   "
186259|NCT00285090|"     The purpose of this study is two-fold. The first is to establish that bone mineral density is     diminished among children admitted to this regional burn center as compared to healthy     non-burned children. The second purpose of this study is to examine the short and long-term     effects of calcium and vitamin D supplementation in on bone metabolism and accrual in     children who have been burned.      Specific Aims: 1) To measure bone mineral content and bone mineral density and their change     during growth in convalescent burned children admitted to a regional burn center and to     compare them to normal, healthy children.; 2) To measure lean body mass, fat mass, total body     water in convalescent burned children admitted to a regional burn center and compare them to     normal, healthy children with focus on how these components of body composition relate to     indices of bone mineral content and density; 3) To identify alterations in bone metabolism     and calcium and vitamin D homeostasis following burn injury and relate these to bone mineral     density in burned children; 4) To test the effect of short term calcium and vitamin D     supplementation on improving bone mineral density, bone mineral content, and indices of     calcium and vitamin D metabolism in acutely burned children.   "
186260|NCT00285103|"     The purpose of this study is to determine whether SPC2996 is effective and safe in the     treatment of Chronic Lymphocytic Leukaemia (CLL)   "
186261|NCT00285116|"     Comparison between 3 groups:        -  group I has hallux rigidus. Is fasicitis plantaris present?        -  group II has fasicitis plantaris. Does the hallux have limited mobility?        -  group III does not have hallux rigidus or fasicitis plantaris   "
186262|NCT00285129|"     Comparison of the functional result and speed of rehabilitation between two types of hip     prostheses: primary ceramic-on-ceramic total hip replacement versus metal-on-metal hip     resurfacing.   "
186263|NCT00285142|"     To evaluate :        -  acute effects of a single dose of 8 mg rosiglitazone (therapeutic dose)        -  on insulin secretion and        -  insulin sensitivity in 12 healthy male subjects.   "
186264|NCT00285155|"     To evaluate the effects of a 14-day repeated dose of 150 mg bupropion (therapeutic dose) on     cognitive and executive functions, behaviour and subjective feelings, after sleep deprivation     in 12 healthy male subjects.   "
186265|NCT00285168|"     This research study is being conducted to determine if a modified bone mineral density (BMD)     test report that contains additional fracture risk information will be a useful physician     decision aide in selecting patients for pharmacological osteoporosis therapy. It is     hypothesized that this supplementary information, provided in addition to the conventional     BMD report, will increase the likelihood that patients at high risk for an osteoporotic     fracture will receive prescribed therapy for osteoporosis.   "
186266|NCT00285181|"     To evaluate the effects of a 8-week treatment with 80 mg/day simvastatin on prooxidant and     antioxidant status at rest and after exercise, on mitochondrial respiration and calcium     release in skeletal muscle, and on aérobic aptitude in 24 healthy male subjects.   "
186267|NCT00285194|"     The collective effects of two-layer pancreas preservation, pretransplant islet culture, day     -2 pretransplant immunosuppression, and induction immunosuppression with the FcR-nonbinding     anti-CD3 monoclonal antibody hOKT3γ1 (Ala-Ala)to facilitate diabetes reversal after     single-donor islet transplantation.   "
186268|NCT00285207|"     A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous     cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the     safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.   "
186269|NCT00285220|"     This two site study will evaluate the safety and effectiveness of laparoscopic truncal     vagotomy for the treatment of obesity with baseline study and 18 month post op follow up.   "
186270|NCT00275197|"     The major purpose of the study is to help determine whether giving the combination of     Elzasonan with Zoloft to people with depression is a better treatment than taking Zoloft     alone. This study will also compare the safety and tolerability of Elzasonan and Zoloft     combination to Zoloft alone or placebo.   "
198541|NCT00447018|"     The purpose of this study is to determine whether mannitol is as effective as hypertonic     saline solution in the treatment of elevated intracranial pressure in patients with brain     injury.   "
186272|NCT00275223|"     This study aims to understand the biological processes that link obesity to diseases     including insulin resistance and diabetes. Our approach involves studying the health of     patient undergoing weight loss either via weight reduction surgery or by medically supervised     liquid formula diets. Patients must be enrolled in a weight treatment program at Emory     Bariatrics, Emory University, Atlanta GA, to be eligible for this study. This study does not     cover the cost of treatment at Emory Bariatrics. The hypothesis is that decreases in     adipose-tissue derived factors during weight loss will be related to improvement in insulin     function.   "
186273|NCT00275236|"     The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in     subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total     time in bed) as measured by polysomnography (PSG). The primary variable is the reduction of     PLMI at the end of the Maintenance Period compared to Baseline. PLMI data will be obtained     from PSGs.   "
186274|NCT00275249|"     The purpose of this study is to determine the extent to which analgesic tolerance develops in     chronic pain patients who are either started on opioids or who receive an increase in     pre-study opioid dose level and then observed during long-term (20 weeks) stable opioid     therapy. In addition to clinical measures of relief of ongoing chronic pain, estimation of     tolerance development will be supplemented by periodic assessment of the anti-nociceptive     effects of opioids using the brief thermal sensitization model.   "
186275|NCT00275262|"     Phase 2 study, conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple     myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell     transplantation.   "
186276|NCT00275275|"     A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in     patients with Parkinson's disease to determine the appropriate conversion ratio and side     effects related to the drug.   "
186370|NCT00286117|"     The purpose of this study was to assess the difference in disease-free survival between     post-menopausal women with hormone receptor-positive early breast cancer who switched from     tamoxifen to anastrozole and those who continued on tamoxifen.   "
186277|NCT00275288|"     MRI Study for females ages 18-45 with Borderline Personality Disorder(BPD): This study is a     non-treatment study that involves 2 visits. Study Hypothesis:        1. To refine and pilot test functional neuroimaging paradigms to assess the amygdala          response to neutral facial expressions across positive and negative emotional contexts.        2. To assess whether patients with borderline personality disorder show a heightened          amygdala response to neutral facial expressions relative to healthy controls (20 female          healthy controls, 20 females with borderline personality disorder).        3. To assess the relationship between individual differences in clinical ratings of          personality and affective regulation, and the amygdala response to facial expressions.   "
186278|NCT00275301|"     The overall design of the study is to perform both a PET and MRI scan on objectively     identified borderline personality disorder patients, to treat them with olanzapine for 8     weeks, and to then re-scan the patients with PET.   "
186279|NCT00275314|"     This is a multi-center, open label, randomized, 3-way cross-over study. 21 subjects will be     randomized to receive all three treatments in one of three treatment sequences.      Patients at risk of CMV disease (D+R-, D+R+, D-R+), who are being treated prophylactically     with Valcyte® (commercially available tablets), after their first or second kidney transplant     and who have adequate renal and hematological function will be eligible for the study.     Screening may be at any time after transplantation provided that follow-up procedures can be     completed during the scheduled time of prophylaxis. The first dose of study drug may be     between 1 and 14 days after screening provided the transplant has stabilized, stable serum     creatinine and steady-state kinetics of ganciclovir and calcineurin inhibitor therapy have     been attained. Follow-up will take place 7- 14 days after last dose of study drug     administration; therefore the duration of the study will be up to 5 weeks.   "
186280|NCT00275327|"     o determine if extended-spectrum beta-lactamases, plasmid-mediated AmpC beta-lactamases,     carbapenemases, chromosomal mutations in ribosomal RNA or other mechanisms of resistance     account for antibiotic resistance in commonly encountered Gram negative and Gram positive     bacteria at UPMC. Also to determine the molecular epidemiology and in vitro susceptibility of     multiply resistant organisms at UPMC and to relate this to antibiotic use in the institution.   "
186281|NCT00275340|"     Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who     are older and sicker than in previous years. Increased patient acuity and reduced hospital     length of stays leave individuals ill prepared for their recovery following discharge.     Individuals experience pain, functional impairment and depressive symptoms following     discharge, which persist for 8 weeks in 50% of individuals. Unrelieved pain, functional     decline and depressive symptoms predispose individuals to adverse events, impaired     health-related quality of life (HRQOL), and increased morbidity and mortality.      Existing supports; including printed education materials, community care resources, cardiac     rehabilitation programs and nurse-initiated telephone follow-up, fail to address concerns of     individuals in this early period following hospital discharge.      Despite the positive health outcomes in other patient populations, valid studies examining     the impact of telephone-based peer support to men and women after hospital discharge from     CABG surgery were not found. It is anticipated that a home-based peer support program,     delivered by telephone, will improve recovery and enhance HRQOL for individuals in the early     weeks post hospital discharge from CABG surgery.   "
186282|NCT00275353|"     The purpose of this study is to examine whether an Individualized Symptom Education Program     (ISEP) is helpful to women to manage their symptoms when they are receiving radiation therapy     for gynecological cancer.      It is expected that women who participate in the ISEP program will be better able to manage     their symptoms and exprience less distress than women who receive usual care.   "
186283|NCT00275366|"     This purpose of this study is to determine the outcomes of the first-known application of     robotic therapy in the rehabilitation following rotator cuff repair, using a novel vertical     oblique robotic module.   "
186284|NCT00275379|"     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design,     exploratory study of orally administered ERB-041 in subjects with active IC. The primary     objectives of this study will be to investigate ERB-041’s activity on levels of urinary APF,     explore the gene expression response in peripheral blood mononuclear cells (PBMC), and to     evaluate the safety of ERB-041 in women with active IC.   "
186285|NCT00275392|"     The purpose of this study is to develop effective exercise intervention to reduce dizziness     and fall risk in older adults with non-specific dizziness. We hypothesize that the use of     vestibular exercises can reduce dizziness and improve gaze and postural stability in older     persons.   "
186286|NCT00275405|"     This research will investigate the effect of garlic oil extract when added to daily diet on     inflammatory mediators and blood clotting activation.   "
186287|NCT00275418|"     Many inflammatory disorders in the body are linked to oxidative tissue damage. Anti-oxidants     that are present in many natural food sources may provide protection from such damage.      Beta carotene is an anti-oxidant vitamin present in many fruits and vegetables. The algae     Dunaliella is particularly rich in beta carotene.      In this prospective trial we want to investigate whether beta carotene from Dunaliella may     prevent exacerbations of Crohn's disease.   "
186288|NCT00275431|"     This is an open-label, multicenter, phase II study to evaluate the safety and efficacy of     single-agent AT-101 in patients with relapsed or refractory B-cell malignancies.   "
186289|NCT00275444|"     A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose     ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple     antiretroviral experienced patients and the dose that achieves the best efficacy and safety     as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and     laboratory profile measures would be selected for further clinical study.   "
186290|NCT00275457|"     To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from     moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week     open label or double blind extension.   "
186291|NCT00275483|"     The purpose of this study is to determine whether stimulation to the akupressurpoint P6 with     a recently developed bracelet are effective preventing postoperative nausea and vomiting   "
192839|NCT00370786|"     To evaluate the effect of bevacizumab for treatment of non-AMD choroidal neovascularization     (CNV); eg:angioid streaks, ocular histoplasmosis, high myopia, idiopathic,etc   "
186292|NCT00275496|"     Subjects must be diagnosed with melanoma. All subjects receive Wide Excision (WEX) of their     melanoma. If the melanoma meets study requirements, the subject is randomized to receive     either (1) no further surgical procedures as part of the study or (2) a Selective     Lymphadenectomy with the possibility of a Complete Lymphadenectomy. Subjects are then     followed for 10 years.   "
186293|NCT00275509|"     The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is     a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney     transplant recipients who have a positive crossmatch with their live donor.   "
186294|NCT00275522|"     The study is being done to compare the safety and effects (good and bad) of three different     combinations of immunosuppression drugs used by kidney transplant recipients while also     looking at their kidney function.   "
186295|NCT00275535|"     This study was done to find out which treatment, tacrolimus or sirolimus, leads to better     long-term kidney function in kidney transplant patients.   "
186296|NCT00275548|"     The study is being done to study the impact of prophylactic administration of antiviral     therapy as compared to initiation of antiviral therapy at the time of clinical recurrence of     hepatitis C infection in liver transplant recipients.   "
186297|NCT00275561|"     This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic     esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the     esophagus becomes filled with large numbers of eosinophils, a type of white blood cell.     Patients who have this condition have difficulty in swallowing (dysphagia) solid food.      Prior to treatment the patients had biopsies of their esophagus and took questionnaires     regarding their symptoms. Treatment was given for 6 weeks, after which biopsies were taken     from the esophagus to measure any changes in the tissue from before treatment. The primary     endpoint was improvement in dysphagia as measured by the validated Mayo Dysphagia     Questionaire. Secondary outcomes included partial symptom response, and histologic (tissue)     response to treatment.   "
186298|NCT00275574|"     Breast pain or mastalgia is a common and troublesome symptom for many women. Whereas cyclical     breast pain related to hormonal fluctuations can frequently be treated, non-cyclical breast     pain can go untreated due to its various etiologies and non-specific presentation.     Acupuncture is an ancient form of Chinese medicine that has been used for centuries to treat     a vast array of illnesses and conditions. Research has shown that acupuncture has a link to a     release of endorphins and other chemicals in the central nervous system. Thus, it is thought     to help relieve pain. To date, there has been minimal research using acupuncture for breast     pain. This pilot of 30 women will seek to determine whether four acupuncture treatments over     a period of two weeks will significantly lower the level of pain experienced by these     participants. Additionally, we will evaluate quality of life measures.   "
186299|NCT00275587|"     Our broad, long-term objective is to create a new non-resident (non-teaching) hospital     service that uses patient-centered critical pathway care plans for treating patients in St.     Marys Hospital. This innovative service, the Hospital Medicine (HOME) Team, will integrate     three timely, high-priority concepts in healthcare: patient-centered quality care,     evidence-based medicine, and principles that define high reliability organizations. The     target populations for the new model of service are patients hospitalized with pre-defined     admission diagnoses who are expected to require only a brief, focused hospital stay of four     days or less. Specifically, we will 1) Design the prototypical approach to be used for     developing all critical pathway care plans by integrating patient-centered quality care,     evidence-based medicine, and principles that define high reliability organizations, 2)     Systematically design the critical pathway care plans for two pre-defined admission diagnoses     (community-acquired pneumonia and non-surgical low-back pain), and 3) Compare outcomes of     this new service against respective historical patient cohorts for patients admitted with     community-acquired pneumonia and non-surgical low-back pain. We anticipate that the     prototypic methodology used to develop this patient-centered service will be replicated for     other new hospital-service models. To our knowledge, there are currently no existing hospital     services in the U.S. that have intentionally integrated principles of high reliability     organizations into evidence-based critical pathways founded on patient-centered principles of     uncompromising quality.   "
186301|NCT00275613|"     Membranoproliferative glomerulonephritis (MPGN) is a relatively-rare, immune-mediated kidney     disease. All current therapies are inadequate and MPGN frequently leads to kidney failure.     This study is a 10 patient trial of the monoclonal antibody rituximab for adult patients with     MPGN. Study patients will receive 2 doses of rituximab intravenously on days 1 and 15 and     will then be followed for 1 year.   "
186302|NCT00275639|"     This research study is being done to study the effects, both good and bad, of calcineurin     inhibitors and the drug Cozaar (losartan), on kidney function and kidney scarring following a     liver transplant.   "
186303|NCT00275652|"     This trial is being done to see if the investigational drug, LdT (Telbivudine), is safe and     effective in the treatment of hepatitis B infection. In addition to this, we will be looking     at the comparison of the effects (good and bad) of LdT and lamivudine.   "
186304|NCT00275665|"     This study is being done in stem cell transplant recipients to see if taking the drug     valganciclovir can prevent or reduce serious cytomegalovirus (CMV) infections that can occur     100 days or later after transplant.   "
186305|NCT00275678|"     This study will compare the outcomes of study participants who have had peripheral blood stem     cell transplantation or with those who have had bone marrow transplantation from an unrelated     donor for the treatment of serious hematological malignancies.   "
186306|NCT00275691|"     Community acquired pneumonia(CAP) is a common cause of morbidity and mortality. The diagnosis     of CAP from the microbiology perspective has been challenging. Recent reports suggest the     utility of real-time PCR for rapid and accurate diagnoses of these pathogens. Real-Time PCR     tests, using the LightCycler instrument, will be performed on excess or additional specimens     after extraction of nucleic acid.   "
186371|NCT00286130|"     In Patients with metastatic colorectal cancer the following treatments first-line     Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.      The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety     as first   "
186307|NCT00275704|"     Flaxseed, a phytoestrogen, is a natural food supplement rich in plant ligands, which have a     very weak estrogen effect. In this study, flaxseed is being evaluated in regard to its     capacity to safely and effectively treat hot flashes. Specifically, this study seeks to     determine if flaxseed will lower the number and severity of hot flashes and if women     experience any side effects from taking flaxseed for this purpose.   "
186308|NCT00275717|"     This study is being done to collect blood and bone marrow samples for biologic studies of     antibody producing cells. Donor specific antibodies can cause damage to the kidneys after     they are transplanted. The study will look at the impact of immunosuppression on antibody     production by antibody producing cells.   "
186309|NCT00275730|"     Prostaglandins (PG) are known to alter regional ocular blood flow and exhibit vasoactive     properties in isolated ocular blood vessels. A variety of animal experiments indicate that     endogenous PGs play a role in the regulation of retinal (RBF) and choroidal (ChBF) blood     flow. There is also evidence that the prostaglandin pathway is involved in the activation of     NO production in humans, however, the mechanisms for interactions between PG and NO in ocular     vasculature are still unclear.      Animal studies suggest that retinal and choroidal blood flow decrease after administration of     indomethacin (a nonspecific cyclooxygenase inhibitor). More recently, it has been shown that     indomethacin injected intravenously decreased optic nerve oxygen tension and reduced the CO2     reactivity. This is probably the result of decreased blood flow through vasoconstriction of     vessels in the optic nerve. Systemic administration of indomethacin also diminishes cerebral,     renal and mesenteric blood flow by an unknown mechanism. However, no clinical trials exist so     far investigating the effects of indomethacin on ocular blood flow. Therefore, the aim of     this study is to investigate the effect of indomethacin on ocular blood flow in healthy     humans.   "
186310|NCT00275743|"     This study is being done to test new way of measuring the relaxation of the stomach after a     meal (called gastric accommodation) by using a MRI scan. This new test will be compared with     the standard test of measuring stomach relaxation that uses radioactive tracers. These tests     will be compared in healthy volunteers and people with upper abdominal symptoms (known as     dyspepsia).   "
186311|NCT00275756|"     Background      Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in     perfusion pressure. The existence of an effective autoregulation in the optic nerve     circulation has been shown in animals and humans. The exact mechanism behind this     autoregulation is still unknown. The motive for the investigation of optic nerve head (ONH)     blood flow autoregulation is to enhance the understanding of pathologic eye conditions     associated with ocular vascular disorders. To clarify the regulatory mechanisms of ONH     microcirculation is of critical importance to understand the pathophysiology of glaucoma,     because there is evidence that glaucoma is associated with optic nerve head ischemia. Several     studies indicate that a disturbed autoregulation might contribute to glaucomatous optic     neuropathy. Currently, five classes of intraocular pressure (IOP) reducing drugs are     available for topical therapy in patients with glaucoma or elevated intraocular pressure.     These drugs have also vasoactive properties, which may influence both the resting ocular     circulation and the autoregulatory mechanisms of blood flow during changes in ocular     perfusion pressure.      Study objective      To investigate the influence of common topical glaucoma therapy on ONH blood flow regulation     during changes in IOP and systemic arterial blood pressure.   "
186312|NCT00275769|"     This study compares the pacemaker's automatic pacing threshold measurements to the manual     measurements conducted by a health care provider.   "
186313|NCT00275795|"     Food allergy reactions cause various health disorders in sensitive people. These reactions     may be IgE-mediated,cell-mediated, energy disturbance-mediated, or a combination of the     three. Certain laboratory diagnostic procedures have been able to identify most IgE-mediated     or cell-mediated food reactions, but so far there is no test available in traditional     medicine to test the energy-mediated allergies and sensitivities. NAET® procedures have been     able to identify food substances triggering to energ disturbances in sensitive people causing     related health disorders. NAET uses one of the testing procedures called NST (Neuromuscular     sensitivity testing).The efficacy of NST-NAET to screen food sensitivity will be evaluated in     comparison with one of the well accepted, established, traditional medicine allergy testing     known as the IgE-specific antigen test.   "
186316|NCT00275886|"     Helicobacter pylori is a major human pathogen that infects over half of the world population.     Infection initiates a series of changes in the gastric mucosa, beginning with gastritis and     leading in some patients to peptic ulcer disease, mucosa-associated lymphomas, and gastric     adenocarcinoma. It is believed that host factors, in particular, the T cell-mediated immune     responses may play an important role in the pathogenesis of diseases induced by H. pylori     infection. Recent results revealed that there were higher IFN-γ secreting cells in gastric     infiltrating T cells isolated from H. pylori infected patients than in uninfected patients,     suggesting that the TH1 response and degree of IFN-γ production is associated with disease     severity. Meanwhile, recent studies have shown that apoptosis of the gastric epithelium is     increased during infection and this response is associated with an expansion of gastric     T-helper type 1 (Th1) cells. In this project, we are trying to further investigate role of     host T cell mediated immune response in pathogenesis of Helicobacter infection by     characterization of the expression of chemokine receptors on gastric infiltrating     lymphocytes. We are going to investigate the mechanisms involving in chemokine/chemokine     receptor interaction in recruitment of gastric infiltrating lymphocytes and pathogenesis of     gastric mucosa damage in Helicobacter infection. This study will be helpful for understanding     the mechanisms of activation and recruitment of gastric-infiltrating lymphocytes during     gastric inflammation.   "
186317|NCT00285233|"     The objective of this study is to assess the safety and efficacy of islet allotransplantation     for the reestablishment of stable glycemic control in patients with type 1 diabetes, using     anti-thymocyte globulin induction immunosuppression with sirolimus, mycophenolate mofetil and     low dose tacrolimus maintenance immunosuppression.   "
186318|NCT00285246|"     Background: Previous deployments like that to the Persian Gulf in 1991 produced veterans with     post-deployment symptom-based health problems with no medical explanation. This was termed     Gulf War illness or medically unexplained illness (MUI). If previous wars are any indication,     some soldiers currently deployed to hostile areas also will return home with unexplained     symptom-based illnesses. However, when this study began there was virtually no pre-war,     prospective data on risk and resilience factors associated with MUI. This study is attempting     to fill that gap.      Objectives: Our goals are to: (a) determine pre- and immediate post-deployment factors     predicting later MUI and poor functional status, (b) improve previous methodological problems     (e.g., selection bias, recall bias and lack of baseline controls) in studies of MUI, and (c)     relate pre-deployment risk factors (e.g., personality, stressor reactivity) and resilience     factors (e.g., coping style, social support) to post-deployment functional status.   "
186319|NCT00285259|"     The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs     (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just     before and after transplantation) and CMV-seropositive recipient-only subjects (related or     unrelated) to determine incidence rates of CMV infection, disease, and other complications     from immunosuppression and/or transplantation. The outcomes for the groups receiving CMV     vaccine will be compared to the outcomes for the group that received the placebo vaccine to     see if there is a clinical benefit. For this trial, donors and recipients must have matched     HLA genotype (matched at 5/6 or 6/6 HLA loci).   "
186320|NCT00285285|"     To compare the effect of “point-of-care” (POC) analysis of blood work with traditional     laboratory methods on length of stay in a pediatric emergency department (PED).   "
186321|NCT00285298|"     The purpose of the investigators study is to assess the impact of therapy with Pentoxifylline     (PTF), a nonspecific phosphodiesterase inhibitor, on kidney function in patients at high-risk     for progression to end-stage renal disease. The investigators hypothesize that therapy with     Pentoxifylline will slow progression of kidney disease over time.   "
186322|NCT00285324|"     This study will examine the use of a variation of standard magnetic resonance imaging (MRI)     called diffusion tensor MRI (DT-MRI) for distinguishing injured brain tissue due to radiation     therapy (radiation necrosis) from the return of a brain tumor that was previously removed     (tumor recurrence). DT-MRI differs from standard MRI in the way that computers process the     images; there is no difference in the experience of having the procedure done. Both radiation     necrosis and tumor recurrence can occur within weeks to months following brain radiation     treatment. Because the treatment and management options for the two conditions differ     significantly, distinguishing the two is of critical importance. Currently, surgical biopsy     is required to make this differentiation.      Healthy volunteers and patients who have received radiation therapy as part of their     treatment for a brain tumor may be eligible for this study. All candidates must be at least     21 years old. Patients must have a new area of abnormality that requires a biopsy to     determine whether it is a tumor recurrence or radiation necrosis. Candidates are screened     with a medical history and physical examination. In addition, patients have blood and urine     tests.      All participants undergo MRI and DT-MRI. MRI uses a strong magnetic field and radio waves     instead of X-rays to obtain images of body organs and tissues. The MRI scanner is a metal     cylinder surrounded by a strong magnetic field. During the MRI, the subject lies on a table     that can slide in and out of the cylinder and wears earplugs to muffle loud knocking noises     that occur during the scanning. Scanning time varies from 20 minutes to 3 hours, with most     scans lasting 40-60 minutes. Subjects may be asked to lie still for up to 20 minutes at a     time. DT-MRI is a type of MRI that measures how water moves in the brain tissue. This     technique uses the same MRI machine as conventional MRI, but the diffusion images are     obtained after the normal MRI scan, and by a computer program that is installed into the     machine. This completes the participation of healthy subjects.      In addition to the scans, patients undergo brain biopsy of the abnormal areas identified by     MRI. Patients' commitment to the study protocol is fulfilled when the surgery is complete;     they may, however, continue to receive follow-up care at the NIH Clinical Center after they     complete the study. They are given the results of the biopsy so that further treatment, if     necessary, can be arranged.   "
186323|NCT00285337|"     The primary purpose of this study is to compare anterior and posterior surgical approach in     treatment of CSM in terms of surgical complications and neurological, functional,     disease-specific and quality of life outcomes measures.      Secondary aims are to quantify the amount of change pre and post-surgery concerning the same     outcome measures; to determine if there are differences in outcomes between posterior     surgical techniques (i.e. laminectomy with fusion or laminoplasty) and examine the     relationship between baseline MRI and baseline and follow-up neurological and functional     outcomes.   "
186324|NCT00285350|"     This is a prospective, multi-center, double-blind, placebo-controlled trial to determine the     efficacy and safety of mycophenolate mofetil (MM) in combination with prednisone as the     initial form of immunosuppression in patients with acquired myasthenia gravis (MG).   "
186325|NCT00285363|"     This descriptive study aims to allow children and adolescents who have cancer to     self-evaluate their quality of life. It is hypothesized that treatment affects quality of     life in the areas of physical and social functioning. It is further hypothesized that these     effects dissipate within 6 months after treatment is completed.   "
201055|NCT00472693|"     The purpose of this study is to determine whether the addition of bevacizumab to Abraxane as     second-line therapy in Her-2 negative, hormone receptor negative metastatic breast cancer.   "
186327|NCT00285389|"     Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C     (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients     under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow     purge with rituximab before an autologous stem cell transplantation for the consolidation of     the patients which fulfilled a response to 4 cycles of (R VAD + C) regimen.   "
186328|NCT00285402|"     The purpose of this migraine prevention study is to evaluate the efficacy and safety of     AST-726 in moderate to severe migraine patients at one of two doses compared to placebo and     compared to a baseline period as measured by a reduction in the number of migraine days.   "
186329|NCT00285415|"     The purpose of this study is to determine the effectiveness of the combination of the two     drugs, docetaxel (Taxotere®) and carboplatin (Paraplatin®) followed by radiation directed at     the tumor in treating your endometrial cancer.   "
186330|NCT00285428|"     This is a Phase I trial to look at safety and how a patient's body will tolerate the     treatment at different dosages.   "
186331|NCT00285441|"     The purpose of this study is to identify differences in TB specific immune responses among     immunosuppressed patients latently infected with TB and patients with active TB.   "
186372|NCT00286143|"     The study exams whether adding an opioid to the epidural infusion of a local anesthetic in     neonates will significantly improve the quality of the postoperative analgesia.   "
186332|NCT00285454|"     Many people in the UK have ischaemic heart disease. Insufficient blood supply to the heart     muscle means that it functions inefficiently, and leads to symptoms of shortness of breath,     chest pain and excess fluid in the body. Recently it has been shown that cells from the     inside of bone are able to produce many different cell types. We are investigating a new     treatment in which a patient's bone marrow cells are taken, and injected into the heart in an     attempt to produce new blood vessels and heart muscle cells. This may lead to a new treatment     for ischaemic heart disease.   "
186333|NCT00285467|"     The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and     4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control     hyperparathyroidism in this group is unknown. The National Kidney Foundation presented     guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients     and active vitamin D therapy in patients with sufficient levels. These guidelines are based     on opinion since there are no significant trials to determine if vitamin D supplementation is     effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol,     and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have     not been compared with vitamin D supplementation with a calciferol (ergocalciferol or     cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in     vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood     pressure and strength. In this proposed study we wish to directly compare the effectiveness     of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with     CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary     endpoints will be change in blood pressure.   "
186334|NCT00285493|"     Clinical trial using antibiotic treatment, namely Rulid, after onset of low back pain.   "
186335|NCT00285506|"     The purpose of the study is to test the effect that contrast media (dye) has on cellular     integrity (structure)   "
186336|NCT00285519|"     The purpose of this study is to examine whether strict blood pressure (BP) control by     doxazosin using home BP monitoring, especially targeting the morning BP level, can reduce     hypertensive target organ damage.   "
186337|NCT00285532|"     The purpose of this project is to help families and communities identify and reduce health     risks from lead, pesticides and, ultimately, other environmental hazards. We have partnered     with the Better Housing League and Baby's Milk Fund in Cincinnati and nationally with the     Alliance to End Childhood Lead Poisoning and the National Center for Lead Safe Housing. The     first specific aim of this project is to evaluate a sampling kit for families to assess     levels of lead and pesticides in their home environment. This aim will strengthen     right-to-know laws by providing families with tools to assess environmental contamination in     their own homes. The second aim is to increase community awareness of the role of     environmental agents in developmental disorders, hearing loss and school problems.   "
186338|NCT00285545|"     The lack of blood flow to the small intestine causes mesenteric ischemia. Using a     Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the     small intestine, we are hoping to identify abnormalities without surgical intervention.   "
186339|NCT00285558|"     The purpose of this study is to determine whether adding a peer-based intervention based on     an outward bound model is more effective than a standard behavioral weight intervention for     helping adolescents lose weight.   "
186340|NCT00285571|"     The relative importance of dietary patterns vs. macronutrient composition in affecting energy     intake and body weight remains uncertain. In this study we propose to investigate the     relative effects of dietary variety vs dietary fat on voluntary energy intake in adults. We     will quantify and compare the effects of typical ranges of variety & fat intakes in the     American diet on voluntary energy intake. The primary hypotheses to be tested are 1)an     increasing availability of entree/side/snack/dessert variety offered will significantly     increase voluntary energy intake in a dose-response fashion when other dietary factors known     to influence energy intake are held constant. 2)The separate effects of dietary variety &     dietary fat on energy intake will be similar.      We anticipate that the results of this investigation will lead to a greater understanding of     the relative importance of eating patterns versus macronutrient composition in the etiology     of obesity, and more specifically, dietary variety versus dietary fat in determining energy     intake. More importantly, it will help lay a foundation for improved dietary recommendations     concerning weight loss and prevention of excess weight gain in adulthood.   "
186341|NCT00285584|"     The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons     with mild-to-moderate depression would be more likely to adopt protective behavior change     when provided with pharmacotherapy for their depression than when treated with placebo.     High-risk behaviors include using illegal drugs and participating in unprotected sexual     intercourse. The specific pharmacotherapy used in this study was the anti-depressant,     bupropion. The subject population consisted of HIV negative men who have sex with men (MSM)     with mild-to-moderate depression.   "
186342|NCT00285597|"     This is a double-blind, placebo-controlled, cross-over study evaluating the effects of UDCA     on peripheral blood flow and immune function in patients with stable chronic heart failure     (CHF). Sixteen patients with CHF will be recruited from the heart failure clinic at the Royal     Brompton Hospital. Following baseline evaluation, patients will be randomised to receive     either placebo or UDCA at a dose of 1000 mg/day for a period of four weeks. They will then     undergo repeat evaluation (peripheral blood flow and immune function). A four week washout     period will then take place before the patients cross-over to receive the respective other     therapy for a further four weeks (i.e. those first receiving placebo will go onto receive     UDCA and vice versa). The study will be completed after a total of twelve weeks, with a final     assessment (peripheral blood flow and immune function).   "
186343|NCT00285766|"     Objective of this 16-week, open-label study is to assess the safety and tolerability of once     daily application of three doses of STS during continuous dosing in the treatment of elderly     subjects with major depression. Subjects will have study visits (clinic visits) at beginning     of study (baseline) and study weeks 1, 3, 5, 8, 12, and 16.   "
186344|NCT00285779|"     The purpose is to assess the response of subjects to etanercept (as compared to placebo) in     treating the physical signs of mucosal and cutaneous lichen planus. The investigators also     wish to assess the effect of etanercept on disease-related itching, pain, and serious adverse     events in patients with lichen planus.   "
186345|NCT00285792|"     The purpose of this study is to examine the effects of increasing the amount of time spent in     recess (outside playtime) on overall daily physical activity in Hispanic preschool age     children attending full-day and half-day preschool programs. We hypothesize that increasing     recess (outside playtime) by 60 minutes in participants attending full-day and 30 minutes in     participants attending half-day of preschool will increase average daily physical activity     during the intervention days. We also hypothesize that children will not compensate for the     increased recess (outside playtime) by decreasing physical activity outside of school during     the intervention days.   "
186346|NCT00285805|"     Thiazolidinedione derivates (TZD's) are Peroxisome-Proliferator-Activated-Receptor-γ agonists     (PPARγ-agonists) and enhance insulin sensitivity. One of the side effects, however, is the     fact that subjects treated with these drugs seem to be more prone to fluid retention. The     precise mechanism of rosiglitazone-related fluid retention is unknown, but it is clear that     either primary or secondary renal sodium retention is part of the mechanism. Furthermore in     observational studies, TZD-related oedema seems to be resistant to loop diuretic therapy. The     recent finding that rosiglitazone induces upregulation of the epithelial sodium channel     (ENaC) in the kidney could be the explanation for TZD-related fluid retention and the     observed resistance to loop diuretics. In the present human in-vivo study the following     hypothesis will be tested:      Rosiglitazone treatment stimulates the activity of ENaC in the distal nephron, which enhances     the natriuretic effect of amiloride and decreases the natriuretic effect of furosemide in     parallel.   "
186347|NCT00285818|"     The purpose of this study is to see whether the medication mifepristone is an effective and     tolerable treatment for increasing the clinical effectiveness of electroconvulsive therapy     (ECT) and protecting cognitive function during ECT. Both Mifepristone and ECT appear to     normalize hyperfunctioning of the hypothalmic-pituitary-adrenal (HPA) axis, which has been     found among patients with major depression referred for ECT. The combination of these two     treatments in major depression may lead to a more rapid clinical response than ECT alone.     Additionally, there appears to be a connection between pre-ECT higher cortisol levels due to     HPA axis hyperfunctioning and post-ECT cognitive impairment. Administration of mifepristone     prior to and during ECT treatment may reduce cortisol levels and reduce the incidence of     cognitive impairment observed after ECT.   "
186348|NCT00285831|"     The purpose of this study is to assess whether the dysphoric-like depressive characteristics     observed in people with epilepsy are unique to this patient population in comparison to three     control groups: Mild Depression (enrolled at Stanford University), Migraine Headaches     (enrolled at Long Island Jewish Medical Center), and Multiple Sclerosis (enrolled at Rush     University Medical Center).   "
186349|NCT00285844|"     The goal of this study is to determine why some obese individuals develop insulin resistance     and others do not. We hypothesize that an impairment in differentiation of fat cells     (adipocytes) is responsible for the development of insulin resistance in select obese     individuals. This study will evaluate obese individuals at baseline with respect to     characteristics of adipocytes, including gene expression, and will then entail randomizing     subjects to either weight loss or treatment with an insulin sensitizing drug (pioglitazone).     Changes in insulin resistance will be associated with changes in adipocyte morphology and     gene expression.   "
186350|NCT00285857|"     The study evaluates if a 6-month course of oral lovastatin at 80 mg/day would decrease     abnormal breast duct cytology in women with a high inherited breast cancer risk.   "
186351|NCT00285870|"     Dr. Sanger and the research team want to learn about upper extremity hypertonia (stiffness)     in children and young adults with cerebral palsy. Specifically, they want to learn about ways     to measure the stiffness in the joints of hypertonic arms. The information the research team     will collect includes any physical exams or computer generated data about your arm movements.   "
186352|NCT00285883|"     30 patients with poor antiretroviral therapy compliance will be identified from our pool of     patients at Saint Michael’s Medical Center and be given Directly observed therapy.   "
186353|NCT00285896|"     GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion     in a glucose dependent way. Below normal plasma glucose levels the effects of GLP-1 stop and     the risk of hypoglycemia is small. However no results exits on the effects pharmacologically     relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in     healthy people after a fasting period when a glucose load is administered. The risk of     hypoglycemia when GLP-1 is administered will be evaluated during these two conditions.   "
186367|NCT00286078|"     The purpose of this study is to evaluate the safety and effectiveness of an implantable     device for difficult to treat migraine. There are a significant number of patients who have     drug refractory migraine and alternative therapies are needed.   "
186368|NCT00286091|"     The purpose of this study is to compare the treatment effect of denosumab with placebo on     prolonging bone metastasis-free survival in men with hormone refractory (androgen     independent) prostate cancer who have no bone metastasis at baseline.   "
186354|NCT00285909|"     Moderate alcohol consumption is associated with a decreased risk of cardiovascular disease     and type 2 diabetes. The association of alcohol consumption with cardiovascular disease is     mediated by a functional polymorphism of alcohol dehydrogenase 1c, but the effect of this     polymorphism on alcohol metabolism is only investigated in vitro.      The risk reduction of moderate alcohol consumption for cardiovascular disease is explained     largely by an increase of HDL cholesterol, but an increase of adiponectin concentrations     after moderate alcohol consumption may also be involved. It seems likely that adiponectin is     a mediator for the association of moderate alcohol consumption with type 2 diabetes. The     mechanism by which moderate alcohol consumption increases adiponectin concentrations is     unknown, but ppar-gamma activation may be involved.      effects of this polymorphism on mediators of this relation are not known. This study     therefore investigates the effect of moderate alcohol consumption and the influence of     alcohol dehydrogenase 1c polymorphism on ppar-gamma activated gene expression and risk     factors of cardiovascular disease and type 2 diabetes.   "
186355|NCT00285922|"     The aim of this study is to improve the detection of heart attack in people who come to a     hospital emergency room (ER) with cardiac symptoms. We are testing a novel technology that     calculates the heart's electrical activity at points all around the upper body torso and     develops a map showing areas indicating heart attack. Our hypothesis is that this new body     mapping technique will be better than the standard electrocardiogram (ECG) in detecting heart     attack.   "
186430|NCT00286910|"     We want to test the hypothesises that patients with nephrotic syndrome have a higher     excretion of AQP2 in the urine,that they have a higher concentration of AVP,and a lower     C-H2O.Everything will normalize, when the syndrome is in remission.Furthermore we want to     test the hypothesis that the expression of mutations in the NPHS2-gene,that codes for     podocin,will cause a lack off or a poorer response in the treatment of nephrotic syndrome   "
186356|NCT00285935|"     We are conducting an eight week longitudinal study to learn if blood levels of certain     naturally occurring compounds and genetic markers differ between patients with depression and     healthy adults who are not depressed, and if any such differences relate to memory     performance, mood, and neurobiology.      We will do this by comparing the unmedicated depressed patients with matched healthy controls     at baseline and then following the depressed patients over the course of eight weeks of     standardized antidepressant treatment to gauge which baseline abnormalities normalize over     the course of treatment.   "
186357|NCT00285948|"     To prospectively obtain data about the clinical and radiological results of the resurfacing     technique as primary hip prosthesis in young active patients   "
186358|NCT00285961|"     This is an evaluation of the functionality and added value of cork splint materials instead     of a plaster splint for children (3-11 years old).   "
186359|NCT00285974|"     Prospective study including 6 groups of 20 patients with a total hip prosthesis. Five     different types of metal-on-metal prostheses are studied, and 1 group with ceramic-on-ceramic     prostheses acts as control group. Patients undergo a clinical evaluation and blood sampling     preoperatively, and 3, 6, 12 and 24 months postoperatively.   "
186360|NCT00285987|"     Study to compare the quality of life after reconstruction of the cruciate ligament in     hospitalized versus day-clinic patient   "
186361|NCT00286000|"     A multicentre phase II study to evaluate the results of high dose simplified folfiri in     advanced colorectal cancer   "
186362|NCT00286013|"     The aim of the study is to evaluate the feasibility defined as overall tolerance and toxicity     as well as relative dose-intensity and cumulative dose delivered, of an association     ofgemcitabine, oxaliplatin and radiotherapy in patients with locally advanced and     unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma   "
186363|NCT00286026|"     Trachoma is the world's leading cause of preventable blindness. This disease, caused by     Chlamydia trachomatis, is endemic in many parts of the developing world. In 1990s we     evaluated the use of community-wide treatment with oral azithromycin in a project called     Azithromycin in Control of Trachoma (ACT). This approach resulted in clinical improvement and     dramatic reduction in prevalence of chlamydial infection through a 1-year follow-up. We     enrolled the ACT villages, as well as an additional village that had not had any prior     treatments, in our ACT II (2005) study and performed clinical surveys to assess trachoma     activity testing conjunctival swabs for the presence of C. trachomatis by nucleic acid     amplification tests (NAATs). Thus, we hoped to determine the long-term (10 year) effects of     azithromycin treatment.      We have completed the census and clinical survey of the initial three villages. Mass     treatment with azithromycin would not be justified with such low rates (1.8 - 4%) of ocular     chlamydial infection. We have treated only those living in households with one or more cases     of chlamydial infection and we will not follow up on these individually treated families.      In order to achieve the goals of our study, we now propose to identify other more remote     villages with trachoma infection rates of 20% or more to evaluate the effect of     community-wide treatment with single dose of oral azithromycin. If one or more of these     villages (dependent upon population) has trachoma rates of 20% or more they will be invited     to participate in the azithromycin treatment. In one set of subjects (1 or 2 villages,     dependent upon population and infection rate) we will perform treatment, and follow them up     at 2-, 12-, and 24-months post-treatment to ascertain infection rates. In a second set of     subjects (1 or 2 villages, dependent upon population and infection rate) we will perform     treatment, then perform re-treatment at 30-days post initial treatment, and follow them up at     2-, 12-, and 24-months post-treatment to ascertain infection rates. This should help us     determine the need for/and the best time for re-treatment to eliminate blinding trachoma, as     some recent studies suggest there is a 2-4% failure rate in the initial treatment. In sum,     this study should provide a rational approach to use of community-wide azithromycin treatment     to eliminate blinding trachoma as a public health problem   "
186364|NCT00286039|"     Correlation between determination of citrulline in plasma or dried blood      Reference ranges for healthy children and babies      Longitudinal follow-up of citrulline in preterm babies   "
186365|NCT00286052|"     Recently there has been an increased awareness in the need for adequate sedation and pain     control for Pediatric Intensive Care Unit (ICU) patients. Fentanyl is an opioid commonly used     in Pediatric ICU patients to decrease pain and increase sedation. Although opioids (e.g.     morphine and fentanyl) provide excellent pain relief, they have many side effects including     dependence, tolerance and withdrawal. These side effects lead to increased doses in order to     maintain pain control and/or sedation. There have been a few adult studies pointing to some     possible treatments. For example, giving low dose naloxone along with opioids. Adult studies     show that this combination not only decreases the frequency of opioid side effects, but also     improves pain control and prevents the development of tolerance. We propose that children who     receive low dose naloxone infusions along with fentanyl infusions will demonstrate: 1)     decreased total daily doses of Fentanyl, 2) decreased frequency of withdrawal and 3)     increased pain and sedation control. In this randomized, blinded prospective trial we will     enroll 168 Pediatric ICU patients. Patients will receive either low dose naloxone or placebo     simultaneously with their fentanyl infusion. Pain and sedation will be assessed using the     Modified Motor Activity Assessment Scale (MMAAS). The fentanyl infusion will be increased to     provide adequate pain control and/or sedation. Naloxone infusion will not be adjusted.     Approximately 48 hours prior to removal from the ventilator, patients will have their     fentanyl infusions decreased while being monitored for withdrawal. Patients showing signs of     withdrawal will receive methadone, an opioid taken by mouth. Once off fentanyl, naloxone will     be stopped. Patients will continue to be monitored for withdrawal for 4 days or until ICU     discharge. If this study works, patients who receive low dose naloxone along with opioid     infusions will have less tolerance and dependence and demonstrate less withdrawal. This may     cause shorter Intensive Care Unit stays.   "
186366|NCT00286065|"     The purpose of this study is to determine the effect of pain relief with AeroLEF in adult     patients, following orthopedic surgery.   "
186369|NCT00286104|"     External ventricular catheters are used for intracranial pressure monitoring and temporary     cerebrospinal fluid (CSF) drainage in neurosurgery. The incidence of ventriculostomy-related     cerebrospinal fluid infections had been quoted as between 2.2% to 10.4% in the more recent     literature. Previous prospective studies in the investigators' unit have shown that the use     of dual antibiotics prophylaxis in patients with external ventricular drain was associated     with decreased incidence of CSF infection but was complicated with opportunistic extracranial     infections. The current practice is to cover with prophylactic dual antibiotics unless guided     by microbiology results for all patients with external ventricular drain. In recent years,     cerebrospinal fluid shunt catheters impregnated with antimicrobial agents have been     available. Experimental studies have shown that they provide protection against     staphylococcal aureus and coagulase-negative staphylococci strains for between 42 days and 56     days. Theoretically, they provide the antibiotic prophylaxis locally without the associated     complications of systemic antibiotics.      It is hypothesized that the use of antibiotic-impregnated catheters instead of systemic     antibiotic prophylaxis will not increase the rate of cerebrospinal fluid infection, will     decrease the rate of opportunistic/nosocomial infections and improves the overall outcome in     these patients; that would convert into a reduction in treatment cost of these patients.   "
186373|NCT00286156|"     This study is a prospective, randomized, open-label, pilot clinical trial designed to compare     the effects of an agent that has antiproliferative (1,2), antiangiogenesis (3),and     tumor-progression blocking capabilities (4), namely, rapamycin (Rapamune®), in the treatment     of autosomal-dominant polycystic kidney disease (ADPKD).      Up to this time, only generic renal disease treatments for ADPKD have been in use, such as     the treatment of hypertension, urinary tract infections, renal stones, renal call carcinomas,     and replacement therapy with dialysis and/or renal transplantation. The fundamental     aberrations in ADPKD are proliferation of cyst-forming tubuloepithelial cells, secretion of     cytokine-rich fluid into those cysts, and progressive cyst expansion and release of     inflammatory mediators that injure surrounding normal renal tissue. Consequently, therapy     directed specifically at blocking the proliferation of tubuloepithelial cells and their     tendency to malignant transformation, as well as impeding their blood supply, should have     obvious merit.      General Procedures:      In Group I participants will have an iothalamate glomerular filtration rate (GFR) equal to or     greater than 60 ml/min/1.73 m2, and in Group II participants will have a GFR less than 25-59     ml/min/1.73 m2. Both males and females with ADPKD who volunteer and qualify, will be randomly     and prospectively assigned to treatment with rapamycin at either a high or low trough blood     level or to standard care (each 1/3 of enrolled patients) for one year. The two treatment     groups will receive rapamycin doses aimed at maintaining the 20- to 24-hour trough blood     levels at either 2 to 5 ng/mL (low-dose), or greater than 5 to 8 ng/mL (high-dose). These     trough levels are in the lower range of levels used when treating renal transplant recipients     in whom trough levels are typically maintained between 5 and 15 ng/mL.   "
186374|NCT00286169|"     The purpose of this study is to compare the efficacy and toxicity of amrubicin with     carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.   "
186375|NCT00286182|"     The purpose of this study is to determine if treating anemia with subcutaneous erythropoetin     in patients with heart failure and a preserved ejection fraction (HFPEF) will be associated     with reverse ventricular remodeling, significant improvements in exercise capacity, and     improved health status, as compared with placebo.   "
186376|NCT00286195|"     To assess the procedural success, performance, 30-day and 6 month clinical outcome of     bifurcation stenting, and the six month incidence of clinically indicated target lesion     revascularization with the use of the Abbott Vascular MULTI-LINK FRONTIER Coronary     Bifurcation Stent System in patients with de novo or restenotic bifurcation lesions.   "
186377|NCT00286208|"     This open-label, randomized study is being conducted to determine whether a dose of 400 mcg     of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of     mifepristone 200 mg is effective and acceptable at inducing an abortion compared with     misoprostol taken orally.      The goal of this study is to provide answers to the following four questions:        1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least          as effective as using oral misoprostol up to 63 days since the last menstrual period          (LMP)?        2. Are the side effects with sublingual use tolerable for women?        3. Is sublingual administration of misoprostol acceptable to women?        4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety          (side-effects) or acceptability?   "
186378|NCT00286221|"     This is a prospective, randomized controlled clinical trial to evaluate the efficacy and     safety of intravenous patient controlled analgesia (IVPCA) in patients following major     intracranial surgery (e.g. brain tumors, vascular surgery). We will compare pain, opioid     consumption, costs, sedation level, length of hospital stay, patient satisfaction, and     complications in patients randomized to receive either PRN or IVPCA opioids. We hypothesize     that IVPCA will be more efficacious than PRN opioids in the treatment of postoperative     without an increased incidence of adverse effects.   "
186379|NCT00286234|"     This research study is being conducted to test the effects of two drugs on blood lipids     (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or     pre-diabetes (both of which have a condition called insulin-resistance). These products     are Niaspan (extended release nicotinic acid) and Omacor (omega-3 acid ethyl esters). We     hypothesize that the combination of Niaspan and Omacor will reduce serum triglyceride levels,     increase HDL-cholesterol levels and do so without altering glucose levels.   "
186380|NCT00286247|"     A maximum of 60 subjects will be enrolled in the trial. It is a non-randomized, open label,     single center study. All subjects undergo INGN 201 injection and IV chemotherapy: doxorubicin     and docetaxel. This is done on the first 2 days of a 3-week cycle. After completion of 4 to 6     cycles, the subject either proceeds to surgery if the tumors respond to therapy, or goes off     study if there is no tumor response.   "
186381|NCT00286260|"     Polyneuropathy of different etiologies is often associated with pain. The standard treatment     of this pain is anticonvulsants or antidepressants, but none of these treatment are effective     or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the     hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised,     double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000     mg/day on pain in polyneuropathy   "
186399|NCT00286494|"     The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily     (QD), combined with pioglitazone in adults with type 2 diabetes mellitus   "
186575|NCT00279409|"     The purpose of this pilot is to initiate a program of research into the development of     effective medication techniques to treat those children with ADHD who are referred because     they are partial or non-responders to standard stimulant treatment.   "
186382|NCT00286273|"     Severely ill patients admitted to the intensive care unit may develop an acute failure of     kidney function. To bridge the period to recovery, renal function is temporarily replaced by     continuous venovenous hemofiltration (CVVH). To prevent clotting of the hemofiltration     circuit, heparin is generally used, providing anticoagulation in the circuit and the patient.     As a result, bleeding complications may occur, necessitating the transfusion of blood.     Anticoagulation of the circuit can also be obtained with the use of tri-sodium citrate, which     provides anticoagulation of the circuit without affecting coagulation in the patient and thus     without increasing his/her risk of bleeding. The use of citrate may however cause metabolic     complications.      Primary aim of the present study is to show in a larger group of intensive care patients     whether the use of regional anticoagulation with citrate is safe compared to systemic     anticoagulation with the low molecular weight heparin nadroparin.   "
186383|NCT00286286|"     The purpose of this study is to determine the effectiveness of aerosolized pain medication     (.5% bupivicaine) delivered into the peritoneal cavity after laparoscopic gastric bypass     surgery. This double blind study will include 50 patients. 25 will receive the aerosolized     pain medication and 25 will receive a placebo (normal saline). All 50 patients will receive     routine/typical methods of post-operative pain management. Post operative pain scores of the     patients will be examined to determine the effect of aerosolization.   "
186494|NCT00287742|"     The purpose of this study is to assess the effectiveness and safety of risperidone (an     antipsychotic medication) versus placebo for the treatment of patients with hallucinations     and delusions associated with Alzheimer's disease.   "
186495|NCT00287755|"     To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant     cancer chemotherapy after gastric surgery   "
186384|NCT00286299|"     This study investigates treatment effects from aerobic endurance training, maximal strength     training and computer game on aerobic capacity, work efficiency and psychiatric symptoms in     patients suffering from schizophrenia. The study is a controlled trial. The aim is to     describe the population in respect to aerobic capacity and muscular strength. Low aerobic     capacity and muscular strength are important risk factors for cardiovascular disease (CVD).     The study also aim to evaluate physical and psychiatric effects from physical training.     Effects from participation in physical training or computer game on symptoms, depression and     quality of life will be investigated. Data will be collected between October 2005 and August     2007.   "
186385|NCT00286312|"     The purpose of this study is to determine if oral atorvastatin administered just before     percutaneous coronary angioplasty for acute myocardial infarction improves early and late     heart function as compared to placebo.   "
186386|NCT00286325|"     This study will determine the safety of treatment of bullous pemphigoid in patients resistant     to therapy with systemic corticosteroids, with rituximab plus systemic corticosteroids.   "
186387|NCT00286338|"     The investigators want to correlate different methods to guide fluid therapy. The     investigators know that guidance by esophagus doppler technique has improved outcome and want     to correlate other already used techniques to esophagus doppler.   "
186388|NCT00286351|"     Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following     IVF outcome   "
186389|NCT00286364|"     We want to investigate if early follicular phase downregulation and androgen priming, by use     of GnRH antagonist, aromatase inhibitor and hCG before COH in a short protocol, shows signs     of improvement compared to standard short antagonist protocol   "
186390|NCT00286377|"     This is a double-blind, placebo-controlled, parallel groups study to determine whether     prosptide is effective in relieving pain in patients who have sensory neuropathic pain     related to their HIV infection or the drugs used to treat it.   "
186391|NCT00286390|"     The purpose of this project is to conduct a scientifically rigorous investigation of the     clinical outcomes, quality of life, and cost associated with the delivery of acupuncture in     the treatment of acute and chronic pain in patients at Malcolm Grow Medical Center, Andrews     Air Force Base.      The specific aims of this study are to:        1. Gather outcomes and patient satisfaction data on patients receiving acupuncture          treatment for acute and chronic pain.        2. Perform an analysis of costs, including any system cost savings, associated with          providing acupuncture services to pain patients.        3. Serve as a model to expand the project to Scott AFB and Travis AFB as per the request of          the Air Mobility Command Surgeon General. (AMC/SG).   "
186392|NCT00286403|"     Patients developing kidney failure after open heart surgery experience an abrupt decrease in     blood flow to the kidney. The investigators hypothesize that administration of fenoldopam     mesylate (a drug that increases blood flow to the kidney) to patients early in the course of     their disease could reduce progression to dialysis-dependent acute renal failure. The     investigators also hypothesize that restoring blood flow could induce additional injury to     the kidney through the release of reactive oxygen species. Therefore, patients in this     protocol will be randomized to receive a fenoldopam or the anti-oxidant MESNA. The     investigators hypothesize that combination treatment with Fenoldopam and MESNA will decrease     the incidence of death or dialysis at 21 days in patients with early post-operative acute     renal failure.   "
186393|NCT00286416|"     Double blind protocol treatment of 2/3 of the patients with omalizumab and 1/3 placebo     administer for 4 months. Patients selected for the study must have both aspirin exacerbated     respiratory disease and allergic asthma and rhinitis. They must also have completed aspirin     desensitization and be taking aspirin on a daily basis for the treatment of AERD.   "
186394|NCT00286429|"     The purpose of this study is to determine the efficacy and safety of alogliptin, once daily     (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.   "
186395|NCT00286442|"     The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily     (QD), combined with metformin in adults with type 2 diabetes mellitus.   "
186396|NCT00286455|"     The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily     (QD), in adults with type 2 diabetes.   "
186397|NCT00286468|"     The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily     (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.   "
186398|NCT00286481|"     The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or     with simvastatin on cholesterol levels in treating patients with elevated cholesterol.   "
186400|NCT00286507|"     A macular hole is a fairly common problem in the retina and is an important cause of loss of     central vision. The aim of this study is to determine whether, in patients with a stage 2 or     3 full thickness macular hole (FTMH), peeling a very fine, transparent tissue that covers the     surface of the retina, called the internal limiting membrane (ILM) during surgery is superior     to non-ILM peeling macular hole surgery. The main outcomes are improvement in vision,     achievement of macular hole closure, need for re-operation, health related quality of life     (HRQOL) and cost effectiveness.   "
186401|NCT00286520|"     The study aims to compare a newly developed system for transanal colonic irrigation     (Peristeen Anal Irrigation) with a bowel management regime that does not include irrigation     in a prospective, randomized trial in spinal cord lesion patients (SCL- patients) with faecal     incontinence and/or constipation.      Population; 80 SCL- patients with faecal incontinence and/or constipation from five     countries.      Focus on:      Bowel symptom score Neurogenic Bowel Dysfunction score Symptom related quality of life     questionnaire Time expenditure for performance of bowel care ans side effects   "
186402|NCT00286533|"     This study is an evaluation of the implants placed in a regular dentist's practice regarding:        -  gingiva condition        -  stability of implant        -  prothetic quality        -  questionnaires for the patients   "
186496|NCT00287768|"     The primary objective of this study is to compare median overall survival of the test arm     (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent     gastric cancer.   "
186403|NCT00286546|"     Context - As men age, testosterone levels decline leading to symptoms that overlap with the     symptoms of major depression. Little is known about the potential role of testosterone in the     treatment of major depression.Objective - To assess the levels of bioavailable testosterone     and total levels of testosterone in men diagnosed with major depressive disorder between the     ages of 40 and 65.Design, Setting and Participants - 50 men between the ages of 40 and 65 and     who suffer from major depressive disorder will be compared with 50 age matched healthy     controls in an outpatient hospital setting. Main Outcome Measures - Bioavailable testosterone     and total testosterone levels will be measured as well as blood pressure, pulse rate, height,     weight, waist and hip measurements. Medical and psychiatric history will be assessed by the     study physician. The Mini International Neuropsychiatric Interview (MINI) will be used to     administered by the physician to ensure that the patient meets the DSM-IV criteria for Major     Depression. The Hamilton Depression Rating Scale (HAM-D-17) will be used to assess depression     symptom severity. A Symptom/Side Effect Rating Scale will also be administered to measure the     presence and severity of side effects that each patient may be experiencing. In addition, the     SEX FX questionnaire will be administered. Each patient will be asked to complete a series of     self-report measures including the Social Adaptation Self-Evaluation Scale Questionnaire     (SASS), the Androgen Deficiency in Aging Males (ADAM) and the Beck Depression Inventory     (BDI-II).   "
186404|NCT00286559|"     Until today it was not possible to reliably assess the function of a new bypass, i.e., to     measure myocardial perfusion. Measuring intramyocardial blood flow directly after     revascularisation would greatly improve the assessment of graft function. With transthoracic     contrast echocardiography, myocardial perfusion can be reliably assessed, as it has been     shown in numerous studies. In the first part of the study the investigators will clarify     methodological aspects of contrast echocardiography. In the second part they will analyze the     validity of contrast TEE in the operating room.   "
186405|NCT00286572|"     Patients with CAD and diabetes mellitus have a better prognosis than patients with CAD and no     diabetes mellitus. In acute coronary syndrome patients with an insulin therapy had a better     survival than patients with oral antidiabetics. But there is not known wether perioperative     therapy with insulin or oral antidiabetics is associated with higher risk for higher     perioperative cardiac morbidity and mortality and worse long-term survival.   "
186406|NCT00286585|"     Volatile anesthetics may provide some protection from myocardial ischemia, an effect called     anesthetic preconditioning. In patients undergoing coronary artery bypass surgery, this     preconditioning effect resulted in better cardiac performance, faster recovery and lower     morbidity and mortality.      The investigators will perform a prospective randomized multi-center study to compare     volatile with total intravenous anesthesia in patients at a high cardiac risk who undergo     major non-cardiac surgery.   "
186407|NCT00286598|"     The role of weight-bearing physical activity in the development of diabetic foot ulcers     remains poorly understood. Regular participation in moderately intense physical activity     (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus     by over 30%. The American Diabetes Association (ADA) recommends at least 30 minutes of daily     moderate intensity activity for people with diabetes. However, the ADA recommends that people     with diabetes and insensate feet, which affects up to 40% of those with diabetes, should     limit their walking because of concerns that walking could increase the risk of foot ulcers     and amputation. Firm evidence is lacking to support these concerns; in fact, while a research     fellow I conducted an observational study that showed daily weight-bearing activity may     reduce the risk of foot ulceration among people with diabetic foot problems. A controlled     clinical trial is needed to study these issues further.      The present study is a randomized controlled trial in 100 older adults with diabetes and     insensate feet, 50 of whom will participate in an individually-tailored behavior-change     intervention called Feet First, and 50 of whom will be controls. The intervention is based     on the extensively-tested CHAMPS model used by the Robert Wood Johnson Foundation's Active     for Life Program. Feet First extends the target population beyond older adults generally to     people with insensate feet due to diabetic peripheral neuropathy.      The specific aims of the study are:        -  To determine whether Feet First intervention subjects achieve a greater increase in          weight-bearing activity than control subjects, and        -  To obtain preliminary evidence on intervention subjects' foot outcomes (foot function,          foot-related self-care, and risk of foot ulcers), compared to control subjects.   "
186455|NCT00287235|"     The primary objective of the study was to compare the efficacy, safety and tolerability of     Extracorporeal Albumin Dialysis (ECAD) using the Molecular Adsorbent Recirculating System     (MARS®) device in improving severe HE by 2 grades compared to Standard Medical Therapy (SMT)     in patients with chronic End Stage Liver Disease (ESLD) during a 5 day study period.   "
201056|NCT00472706|"     The purpose of this study is to identify the most optimal therapy for Bowen's disease:     excision versus Photodynamic therapy.   "
186408|NCT00286611|"     Currently, there are no published methods for easily determining the level of amifostine in     the blood or saliva. A method has been developed within the Department of Radiation Oncology     by Drs. Douglas Spitz and Gurminder Sidhu, within the Spitz Lab. This method has been tested     using both animal sampling and expired blood (obtained from DeGowin blood center) mixed with     amifostine.      If the method proves successful, it could then be used as a tool to quantify blood and     salivary amifostine levels and possibly correlate them to treatment efficacy or limiting     adverse events using amifostine. A better method of treatment, either increasing the efficacy     of amifostine or reducing its unwanted side effects, could then be developed.   "
186409|NCT00286624|"     This study was designed to test the safety and efficacy of up to 3 pancreatic alloislet     transplants in type 1 diabetic patients with hypoglycemia unawareness. 6 subjects were     transplanted under this protocol using anti-thymocyte globulin induction immunosuppression     and everolimus with cyclosporine maintenance immunosuppression.   "
186410|NCT00286637|"     The purpose of this research is to evaluate novel technologies for the assessment of ocular     structure and function, including the scanning device called Optical Coherence Tomography     (OCT). We will test the OCT and other devices in their ability to image diseases of the eye     and also compare the measurements made with OCT to those of other imaging and visual field     devices approved by the Food and Drug Administration (FDA). OCT may be useful for the early     diagnosis and monitoring of a variety of types of eye diseases   "
186492|NCT00287716|"     The objectives of this study are to assess the safety and efficacy of treatment with     pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic     pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone     1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the     pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.   "
186411|NCT00286650|"     Paracetamol is commonly used to reduce pain after operations. Recently anaesthetists have     been using bigger doses of paracetamol because it has been suggested that bigger doses will     work better. However these bigger doses have never been assessed scientifically in adult     patients to see if they work better, and it has not been determined at which dose the maximum     effect in reducing pain occurs. We We will investigate whether a 90 mg per kg body weight     dose works better than a 60 mg per kilogram dose, in reducing pain after wisdom tooth     extraction. We will also examine the pharmacokinetics (the way the body removes the drug) of     paracetamol, and whether paracetamol changes the way blood clots at these doses. We will also     examine whether these doses are safe, by monitoring liver enzymes, and making sure the blood     level of paracetamol is not greater than that previously recognised to cause liver disease.     The patients will be healthy volunteers scheduled to have wisdom tooth extraction. They will     have blood taken at intervals for four hours after having the paracetamol. They will fill in     pain scores at the same times they have blood taken.   "
186412|NCT00286663|"     The purpose of the study is to determine the role special antibodies play in possibly     identifying Autoimmune Hepatitis through the following:      Identify the response of specific T cells to antibodies and Monitor the response of the cells     that regulate the immune system   "
186413|NCT00286676|"     This is a pilot study. We will treat 10 HIV-infected adults (1/2 with lipoatrophy) with GH     depot for one year. Results will be compared to data from 10 HIV patients (1/2 with     lipoatrophy), treated with Nutropin AQ subcutaneously. The primary endpoint of the study is     to determine the effect of GH depot on body weight and lean tissue mass (LTM).      The secondary endpoints are to document changes in: 1) whole body protein turnover (WBPT), 2)     gluconeogenesis, 3) bone mineral density and markers of bone turnover, 4) fat distribution     (lipoatrophy), 5) thymus size, 6) T-cell subsets, and 7) TNF-µ levels. Adverse events, such     as glucose intolerance and edema, will be monitored at every visit.   "
186414|NCT00286689|"     The specific aims for this study are –        1. To determine the effect of GH on height, height velocity, body weight and lean body          mass. This specific aim tests the hypothesis that GH significantly improves height,          height velocity, weight, weight velocity and lean body mass in chronically ill children          who have grown poorly despite adequate nutritional rehabilitation.        2. To determine the effect of GH on whole body protein turnover (WBPT), IGF-1 levels and on          cytokines. This specific aim tests the hypothesis that chronically ill children have          increased catabolism, caused by high levels of circulating cytokines and low levels of          IGF-1, and that these abnormalities improve with GH treatment.        3. Evaluation of bone mineral density and bone turnover. This specific aim tests the          hypothesis that bone density is low in chronically ill children secondary to increased          osteoclast activity correlating with elevated cytokine levels.      We hypothesize that the anabolic effects of growth hormone (GH) will improve the height and     weight of chronically ill children who have failed to grow despite receiving adequate     nutrition via gastrostomy tube or oral supplementation.   "
186415|NCT00286702|"     After a stroke, many people develop contracture of the muscles in their affected wrist and     hand which leads to a permanently clenched, painful hand. A contracture is often treated by     therapists who use hand splinting to prevent it occurring or slow down its progression.     Despite their wide use, there has not been research completed to investigate whether or not     splinting prevents contracture in people following stroke. In fact, this project will be the     first of its kind in the world and is therefore vital to stroke rehabilitation.      The study is a multi-centre, randomised controlled trial that will measure the effect of     hand-splinting in two positions on the prevention of contracture, functional use of the hand,     and quality of life.   "
186416|NCT00286728|"     This project will help counselors in substance abuse treatment programs make effective     referrals of dually diagnosed patients (those with a co-occurring psychiatric disorder) to     self-help groups.   "
186504|NCT00287872|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood     flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide     works in treating patients with newly diagnosed stage II or stage III multiple myeloma.   "
186576|NCT00279422|"     The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects     with intravenous steroid-refractory ulcerative colitis.   "
186417|NCT00286741|"     Background: Diabetes is a common, morbid and expensive disease among veterans. Achieving     adequate glycemic control and blood pressure control can reduce the devastating complications     of diabetes. Because the majority of patients do not achieve adequate control of blood sugar     and blood pressure, innovative strategies to improve control are needed. One strategy with     great potential for veterans receiving VA care is the group clinic. Group clinics have been     developed over the last 5-10 years, and have been shown to improve clinical outcomes and     reduce outpatient utilization in geriatric settings. Group medical clinics involve a cohort     of 8-20 patients who have 1-2 hour group visits. These clinics are distinguished from     traditional group education visits for diabetes by the fact that these visits involve one     physician and one or more additional health care professionals, usually a nurse practitioner     and/or a pharmacist, and are designed to make management changes for a number of people with     the same disease in a short period of time. The effect of group medical clinics on blood     sugar, blood pressure, and the cost of diabetes care, is unknown. Objectives: Our primary     objectives in this project are to determine the effectiveness and cost-effectiveness of a     group visit intervention in improving rates of control of diabetes and high blood pressure in     patients with both illnesses.   "
186418|NCT00286754|"     The purpose of this study is to determine whether a stage-matched intervention (SMI) will     lower BP and improve treatment adherence compared to usual care (UC) or a health education     intervention (HEI) in veterans with uncontrolled BP. The study will also examine the effect     of SMI on patient's health-related quality of life, satisfaction, acceptability and determine     its cost-effectiveness.   "
186431|NCT00286923|"     The purpose of the study is to determine by the use of non-invasive magnetic stimulation if     the medication Topiramate adjusts the excitability of the migraine sufferer's brain.      Previous studies have shown the migraine sufferer's brain is more excitable. The magnetic     stimulation device has given us a way to look at excitability and to see if it changes at the     same time that a headache diary shows if the pattern or severity of headaches changes with     the administration of the drug Topiramate.      It is expected that as migraine sufferers have fewer headaches with topiramate the testing     with magnetic stimulation will show that their brains are less excitable and that if the     topiramate does not change the character of headaches then the pattern of excitabilty would     not change from the baseline test before medication is started.   "
186432|NCT00286936|"     To examine the influence of regular hypnotic therapy on the incidence of delirium after hip     fracture surgery   "
186419|NCT00286767|"     This study will investigate what factors may lead to the development of immune reconstitution     syndrome (IRIS) in HIV-infected patients and what the outcome is after IRIS. It will also     seek to better define and describe the syndrome. IRIS is a condition that can occur in     HIV-infected people following the start of antiretroviral therapy. The sudden improvement of     immune function with this therapy can cause an unexpected worsening of diseases the patient     already has, such as tuberculosis or fungal infections, and development of fever, enlarged     lymph nodes or other complications, or even uncover a previously silent disease.      HIV-infected people who are at least 18 years old, whose CD4+T cell count is 100 cells per     microliter or less, and who have not previously been treated with combination antiretroviral     therapy or have taken the drugs for less than 3 months and more than 6 months before     screening for this study may be eligible to participate. Candindates must also live within     the wider DC area so that acute problems after therapy initiation will be evaluated at NIH.     Candidates are evaluated before starting therapy with a medical history and physical     examination, blood and urine tests, electrocardiogram, chest x-ray and CT scan of the chest,     tuberculin skin testing, apheresis, and possibly an intestinal (gut) and lymph node biopsy     (surgical removal of a small piece of tissue for microscopic examination). For apheresis,     blood is collected through a needle in an arm vein and spun in a machine that separates the     blood components. The white blood cells and plasma are removed, and the red cells and     platelets are returned through the same needle or through a needle in a vein in the other     arm.      Participants have a complete history and physical examination and additional blood tests,     including genetic studies, upon entering the study. They start taking anti-HIV medications,     prescribed according to the current standard of care, as well as medications to treat other     infections, and treatment of IRIS, if needed. The study lasts about 4 years. Patients return     to the clinic at 2, 4, 8 and 12 weeks after the entry visit, then every 12 weeks (about every     3 months) until week 48 (the first year), and then every 16 weeks (about every 4 months)     until the end of the study. At most visits, patients have a medical history, physical     examination and blood and urine tests, including CD4+T cell count and HIV plasma viral load     measurement. Apheresis is also done at weeks 24 and 48 and then once every 48 weeks.     Intestinal and lymph node biopsies (optional) are also done at weeks 24 and 48. A syphilis     test and PAP smear (for women) are done yearly. and plasma, cells and serum are stored at     almost every visit for immunologic studies.   "
186420|NCT00286780|"     This is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in     combination with rituximab in patients with relapsed or refractory chronic lymphocytic     leukemia.   "
186421|NCT00286793|"     This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of     AT-101 in combination with docetaxel and prednisone in men with hormone-refractory prostate     cancer that are either chemotherapy naive or have received and progressed on a docetaxel     containing regimen,   "
186422|NCT00286806|"     This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of     single-agent AT-101 in men with hormone-refractory prostate cancer.   "
186423|NCT00286819|"     This is an open -label randomized phase II study of dose-dense     Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2     (FEC75) and Epirubicin 90mg/m2 (FEC90) in untreated patients with early breast cancer.   "
186424|NCT00286832|"     Early identification of refractory lymphoma patients provides a basis for stratification     between responders to standard approaches and non-responders who may benefit from an early     change to an alternative treatment strategy.Metabolic or molecular imaging with fluorine-18     fluorodeoxyglucose positron emission tomography (18F-FDG-PET) has emerged as a powerful     imaging modality for diagnosis, staging, and therapy monitoring of a variety of cancers. The     primary hypothesis of the present study is that early response can be pinpointed by PET     reflecting both tumor burden and activity, as a surrogate for final outcome. An increasing     number of studies have suggested the potential role of 18F-FDG PET in the staging and     monitoring of lymphomas. The optimal timing of PET scans and the potential role of     quantitative PET using SUV to assess response to chemotherapy remain to be defined.     Confirmation of very early 18F-FDG-PET as a significant predictor of treatment response in a     homogenous group of aggressive lymphoma patients would potentially change the prognosis of     the patient by allowing earlier use of alternative therapies and discontinuation of therapy     that will not lead to a significant tumour response.   "
186505|NCT00287885|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Docetaxel may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving     daily doses of docetaxel may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel in     treating patients with refractory or recurrent advanced gynecologic cancer.   "
186425|NCT00286845|"     A previous preliminary study performed at Vanderbilt University with funding from the     Leukemia Society of America demonstrated that the response of leukemia cells in vitro to the     chemotherapeutic agent idarubicin in the microculture kinetic assay for apoptosis (MiCK     assay) predicted survival in patients with newly diagnosed acute myeloid leukemia (AML). In     this previous study, achievement of complete response (CR) to induction therapy with     idarubicin and cytarabine was used as the clinical indicator for determining whether leukemia     specimens taken prior to treatment were sensitive or not sensitive in the MiCK assay. This     group of patients has been followed for 7 years and their long term survival rates show that     their responses in the MiCK assay to idarubicin but not cytarabine predict survival. In the     present proposal a separate group of patients with newly diagnosed AML will be recruited to     provide leukemia cell samples that will be used to establish criteria for sensitivity and     non-sensitivity to idarubicin and cytarabine in the MiCK assay. The achievement of CR will be     used to determine in vitro sensitivity as it was done in the previous study. With the in     vitro sensitivities as determined in this proposed study, the long term survivals of patients     in the previous study will be analyzed prospectively.      The proposed study is expected to have an approximate duration of one year. Patient     population will include newly diagnosed AML patients with both de novo AML and AML arising     from a previously diagnosed myelodysplastic syndrome. The study will not include patients     with previously treated leukemia that has relapsed   "
186426|NCT00286858|"     This study shall evaluate in daily medical practice the clinical results of the AV delay     hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for     one of the three following indications: sinus node dysfunction, atrial disease (or     bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome     of automatic functions will be evaluated.   "
186427|NCT00286871|"     Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help     prevent post-transplant rejection.   "
186428|NCT00286884|"     The aim of the study is to investigate heart rate variability in patients with white coat     hypertension and patients with essential hypertension.   "
186429|NCT00286897|"     Patients will be randomised to receive either placebo or the study drug for a period of 30     weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the     patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder     of the 22 weeks, all medications should be kept stable. Patients will be required to attend     the clinic twice during the screening period and then a further 8 times during the treatment     period. They will be required to complete home diaries where they will record their motor     function. In addition, their doctor will assess their Parkinson's disease during the clinic     visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics     evaluation. Following the treatment and assessment period, they will return to the clinic one     month later for follow up.   "
186433|NCT00286949|"     Atomoxetine (Strattera) is a drug that is currently approved for treatment of attention     deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine works to enhance     levels of brain chemicals that may be affected in people with executive dysfunction,     (difficulties with organization, task completion, and priority setting). Thus, atomoxetine     has the potential to improve executive dysfunction in people with Parkinson's disease (PD).      The goal of this study is to provide preliminary data on the effectiveness and tolerability     of atomoxetine for the treatment of executive dysfunction in patients with PD.   "
186434|NCT00286962|"     The purpose of this study is to compare intraperitoneal (IP) therapy to subcutaneous     administration of insulin regarding safety, glycemic control and number of episodes of     hypoglycemia in patients with type 1 diabetes mellitus.   "
186435|NCT00286975|"     Study objective: The objective of this trial was to determine the effectiveness of a     Leadership Development Program (LDP) aimed at 1) establishing basic management knowledge and     2) promoting reflection of leadership skills.      Study design: Randomized, controlled, single-blind trial. Study participants: Senior     postgraduate medical and surgical trainees at an urban university health care centre.      Methods: Eligible participants were randomized to either the LDP(intervention group) or to     regular postgraduate training (control group). For ethical reasons, all participants assigned     to the control group were offered the LDP at the end of the trial. The 1º outcome measure     used was a knowledge-based written exam. The sample size was estimated on finding a 20%     difference in mean test scores between groups. Participants' reflective capacity and higher     order leadership role skills were tested through a personal learning project (PLP, 2º outcome     measure).   "
186436|NCT00286988|"     The purpose of this study is to assess the effectiveness, tolerability and safety of oral     topiramate for the preventative management of Cyclic Vomiting Syndrome. It is believed that     topiramate will decrease the frequency, duration and severity of attacks experienced by     children and adolescents with Cyclic Vomiting Syndrome.   "
186437|NCT00287001|"     - To investigate the benefit of epidermal cooling on the incidence of post inflammatory     hyperpigmentation after laser irradiation   "
186438|NCT00287014|"     The purpose of this study is to find out how, why, and when Rift Valley Fever (RVF) spreads.     Participants will be 250 adults and children, aged 1 year and older, from the Ijara District,     Kenya. They will be given a questionnaire, undergo a medical examination that includes an eye     exam, and have a 1-teaspoon sample of blood taken from a vein. Participation will take about     3 hours.   "
186439|NCT00287027|"     Patients who have schizophrenia, schizoaffective disorder, a psychotic disorder, and are     being treated with a medication called Risperidone Long Acting Injectable medication or     another antipsychotic medication are candidates for the study. The purpose of the study is to     find out from patients' family how they feel the medication has affected their relationship     with them. The study will involve meeting with family members three times over the course of     one year. The first time will be at New Hampshire Hospital (NHH) or at a community mental     health center and the follow up times will be at a convenient place and time for the family     member (s), in the community. We will ask them to answer questions from the Family Burden     Interview and Quality of Life Questionnaire. The family will not be charged for any test that     is completed solely for this study. The family will be provided a travel stipend to meet with     the researchers.   "
186440|NCT00287040|"     The purpose of this study is to compare mammography adherence among women receiving tailored,     interactive mammography interventions via DVD and telephone counseling to usual care.   "
186441|NCT00287053|"     The purpose of the proposed study is to identify the mechanisms responsible for the weight     gain associated with Depakote treatment, and to identify methods to prevent and treat weight     gain in people taking Depakote. Both sides of the energy balance equation will be measured in     a sample of healthy lean and overweight adults. Energy intake will be measured in the     Pennington Center's Eating Laboratory, and total daily energy expenditure (TEE) and posture     allocation will be measured with the IDEEA™. Questionnaires that assess food cravings and     eating attitudes and behaviors will be used to determine if a behavioral phenotype is     associated with weight gain in response to Depakote treatment. It is hypothesized that     Depakote treatment will result in increased food intake. It is also hypothesized that the     time spent engaging in sedentary behavior will increase in response to Depakote treatment.     Time spent engaging in, and the energy expended during, physical activity is expected to     decrease significantly. Therefore, it is hypothesized that TEE is expected to decrease     significantly. The results will be used to identify specific behavioral targets to prevent     weight gain during treatment with Depakote. Potential targets include interventions to modify     food intake and physical activity. The degree to which each behavior (food intake or physical     activity) will be targeted is dependent on the results of this study. For instance, if the     majority of the weight gain associated with Depakote treatment is due to changes in food     intake, stronger dietary interventions will be suggested. Additionally, changes in endocrine     factors (hormones and peptides) will be evaluated during the study to determine if Depakote     is associated with an altered endocrine response that affects satiety, food intake, or energy     expenditure. If an altered endocrine response is found, these results will be used to     identify adjunctive medications or compounds to correct the endocrine response and reduce     weight gain. Genomic studies will also be possible, since gene sequencing and gene expression     can be analyzed from archived buffy coat samples.   "
186442|NCT00287066|"     To assess the impact of inhalation of insulin on glucose disposition in patients with type 1     diabetes   "
186443|NCT00287079|"     The primary objective of this initiative is to assess the effectiveness of subcutaneous (sc)     interferon (IFN) beta - 1a, (Rebif®), versus No Treatment in delaying the conversion to     Clinically Definite Multiple Sclerosis (CDMS) - as defined by the occurrence of a second     exacerbation - over 96 weeks in subjects that present with Clinically Isolated Syndrome (CIS)     accompanied by an abnormal magnetic resonance imaging (MRI). The secondary objectives are to:        -  Assess the effectiveness of sc IFN beta - 1a (Rebif®) therapy in reducing the proportion          of patients with CIS converting to CDMS        -  Assess the safety of sc IFN beta - 1a (Rebif®) in the patients with CIS   "
186444|NCT00287092|"     Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active     immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive     infections caused by Haemophilus influenzae type b. However there are currently no clinical     data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule.     This study is designed to provide safety and immunogenicity data to support the use of     Pediacel™ according to a 3, 5, and 12 months schedule.   "
186445|NCT00287105|"     The purpose of this study is to determine whether Imatinib is safe and effective in     association with intensive treatment of Ph+ALL in children.   "
186446|NCT00287118|"     Phase IIIb, open-label, multi-centre study to establish psoriasis control of moderate to     severe plaque psoriasis with Raptiva therapy administered SC for 24 weeks.   "
187333|NCT00289406|"     The goal of this study is to compare the antihypertensive effect and tolerability of     S-amlodipine gentisate with those of amlodipine besylate in patients with mild to moderate     hypertension.   "
186447|NCT00287131|"     Metastatic melanoma is an aggressive and highly malignant cancer. The five-year survival rate     of patients with metastatic disease is less than 5% with a median survival of only 6-10     months. Drugs like Dacarbazin (DTIC) as a single agent or in combination with other     chemotherapy agents, have a response rate of 15-30%, but the duration of response is usually     short, with no impact on survival. Interleukin-2 (IL-2) based immunotherapy has shown more     promising results. This form of therapy has a similar response rate with some patients     achieving a durable complete response. Recently the National Institute of Health (NIH)     reported that by using lympho-depleting chemotherapy, followed by an adoptive transfer of     large numbers of anti-tumor specific tumor-infiltrating lymphocytes (TIL), an objective     regression was achieved in 51% of patients with metastatic melanoma.      Objectives: To introduce the TIL technology to advanced metastatic melanoma patients in     Israel.   "
186448|NCT00287144|"     The study tries to determine if post partum thyroiditis has marked long term (20 years after     partum) risk for developing hypothyroidism.   "
186449|NCT00287157|"     Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine,     a known anti-spasticity medication, has been shown in a previous study to improve sleep and     next-day functioning in CP (cerebral palsy) patients. It is hypothesized that this     improvement in sleep efficiency (i.e.,fewer wake episodes, longer time asleep, etc.) with     resulting improvement in quality-of-life (i.e.,improvements in next-day functioning,     cognition and movement) may also be seen in a similar patient population, i.e., children with     traumatic brain injury (TBI).   "
186450|NCT00287170|"     The study is being undertaken to evaluate whether delayed-release medications, designed to     begin to open in the lower intestinal tract, the main site of Crohn's Disease, are more     effective than standard systemically delivered drugs to promote remission or response in CD     patients. It is hypothesized that the delayed-release medications will go right to the     injured tissue and heal the disease more quickly.      The delayed-release test drugs are 6-mercaptopurine (at a dose of 40 mg daily) or calcitriol     (at a dose of 5 mcg three times a week) versus Purinethol (6-MP at a dose of 1-2 mg/kg body     weight daily). Calcitriol is a synthetically manufactured replica of a natural substance in     the body that is derived from Vitamin D. There is much medical evidence that shows that lack     of Vitamin D can be a possible risk factor in developing autoimmune disorders, including     Crohn's Disease. Moreover, calcitriol has been shown in animal models to improve the symptoms     of Crohn's Disease.   "
186451|NCT00287183|"     Current research indicates that TTP488 may be a viable agent for the treatment of diabetic     nephropathy. The purpose of this study is to determine the safety and efficacy of a six-month     regimen of daily orally-administered TTP488 to patients with diabetic nephropathy.   "
186452|NCT00287196|"     This trial seeks to establish the role of post-operative radiotherapy in patients who have     had surgery for melanoma involving lymph nodes and who are at high risk of recurrence.   "
186453|NCT00287209|"     The purpose of this study is to determine whether postoperatively oral treatment with high     dosis amiodarone for five days after intravenously admitted bolusinfusion will minimize the     risk for development of atrial fibrillation after coronary artery bypass grafting.   "
186454|NCT00287222|"     The primary efficacy endpoint will be the proportion of subjects that remain free of     progression at the 27th week following the onset of treatment. Secondary objectives include     the subject's time in weeks from treatment onset to documented disease progression as     assessed by the RECIST criteria, response rate, median and overall survival, safety and     tolerability.   "
186456|NCT00287248|"     This research is designed to obtain efficacy and safety information for 123-I IMPY as an     imaging biomarker for Alzheimer's disease (AD). The distribution of this agent will be     measured by obtaining single photon emission computed tomography (SPECT) images of the brain     serially over time to determine the relative localization of the radiopharmaceutical in     regions of the cortex relative to background regions and develop an optimal technique of     radiotracer administration (bolus or bolus with constant infusion). The researchers will then     evaluate the utility of 123-I IMPY and SPECT in AD patients as an early diagnostic tool and     subsequently serial evaluations of AD patients will be performed to determine if this     technique may be useful as a tool for evaluation of progressive brain β-amyloid deposition in     AD.   "
186457|NCT00287261|"     In this trial, the question is addressed if zoledronic acid (Zometa, Novartis Pharma)could be     of clinical benefit for patients with myelofibrosis and myeloid metaplasia (MMM).   "
186458|NCT00287274|"     Device: computerized physician order entry.      We wanted to investigate if the introduction of a computerized intensive care unit system     reduced the incidence and severity of medication prescription errors (MPEs). A prospective     trial was conducted during 5 weeks in a paper-based unit versus a computerized unit. The     registration of different classes of MPEs was done by a clinical pharmacist. An independent     panel evaluated the severity of MPEs.   "
186459|NCT00287287|"     The primary objective of the study is to assess the anti-tumor activity of REVLIMID®     (lenalidomide), administered as a single agent, in patients with distantly metastatic thyroid     carcinomas which are unresponsive to systemic radioiodine, in terms of tumor response and     response duration.   "
186460|NCT00287300|"     The purpose of this study is to compare the efficacy and safety of three treatment regimens     for the prevention of malaria during pregnancy.   "
186461|NCT00287313|"     The purpose of this study is to determine if daily Vitamin K supplementation stabilizes INRs     in patients taking warfarin with a history of frequent dose changes or variable INRs.   "
186462|NCT00287326|"     The purpose of the study is to determine if a low-dose epidural drug mixture without narcotic     will result in lower parenteral narcotic usage, and improved side-effect profile for     post-operative pain in the pediatric population undergoing lower extremity or pelvic     osteotomy.   "
186910|NCT00292084|"     This is an extension study of HCV-05-002. The objective of this study is to evaluate the     safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for     an additional 36 weeks in patients with chronic hepatitis C genotype 1 infection.   "
186463|NCT00287339|"     The purpose of this research study is to investigate different doses of proton pump     inhibitors in reducing cough symptoms felt to be associated with Gastroesophageal reflux     disease (GERD). Proton pump inhibitors are medicines used to treat GERD, which work by     lowering the amount of acid in the stomach.      The proton pump inhibitor used in this study is called, Esomeprazole (brand name Nexium), and     is already marketed for treating GERD. Patients with GERD may experience all or some of the     following symptoms: stomach acid or partially digested food re-entering the esophagus (which     is sometimes referred to as heartburn or regurgitation), belching and coughing. Even very     small, unnoticeable amounts of rising stomach acid may cause patients to cough.      Because there may be a link between chronic cough and GERD, study doctors are interested in     learning if giving high-dose Nexium (40 milligrams, twice daily) will help in treating     chronic cough.   "
186464|NCT00287352|"     Weight gain associated with antipsychotic medication use is a major side effect that limits     the tolerability of these drugs. This often significant weight gain adversely affects health,     increasing risks for developing cardiovascular disease, diabetes, sleep apnea, cancers of the     colon, kidneys, uterus, endometrium and esophagus and osteoarthritis. Beasley and colleagues     (1997) reported that 40.5% of olanzapine-treated patients gained more than 7% of baseline     weight. Much of the olanzapine induced weight gain occurs early in treatment, and     antipsychotic-naïve and young patients (Woods et al., 2002) are particularly vulnerable to     this side effect. One of the most promising medications to aid weight loss in patients taking     olanzapine is amantadine.      Attempts at preventing weight gain are expected to be more successful than attempts to     reverse it once it occurs. It is now common clinical practice to educate all patients     beginning treatment with olanzapine, and other antipsychotics, about healthy eating and the     need for exercise. However, despite this effort, weight gain in this population continues.     Beginning a weight-stabilizing medication after a low threshold of weight gain has occurred     may have significant impact on patients' health and their willingness to continue to take     antipsychotics.      We propose to investigate the efficacy of amantadine as a weight-stabilizing agent in a     population of first-episode psychotic subjects just beginning treatment with antipsychotic     agents. This population is generally young and medically healthy, without contraindications     to amantadine. They are often of normal body mass index and without obesity-related medical     problems. They have much to gain in preventing the weight gain which so often progresses     steadily over the course of treatment, is difficult to reverse and results in significant     morbidity and mortality. Additionally, the first episode psychotic population tends to take     fewer concomitant psychiatric medications. This is important since these medications may     cause weight gain (long term use of mirtazapine, lithium, depakote) or weight loss (short     term use of SSRI's) which could confound the effectiveness of amantadine to combat weight     gain.   "
186465|NCT00287365|"     Recent reports have shown that people with asthma who have a particular gene, known as the     GSTM1 null gene, are more susceptible to the effect of air pollutants. The purpose of this     research study is to learn if volunteers who have asthma and have a GSTM1 null gene have     increased response (change in lung function and increase in lung cells collected from sputum)     compared to volunteers with asthma who have the GSTM1 sufficient gene when challenged with     0.4 ppm ozone during intermittent exercise. The principal purpose of this study is to     identify hyper-responsive, responsive and non-responsive groups of human subjects with mild     asthma based on their airway neutrophilic response to ozone exposure, and to perform analyses     on DNA from airway cells to explore possible differences in genetic profiles between the     three groups. An additional pilot aim is to compare expression of a small number of specific     genes of interest in a subset of ozone-responsive and ozone-non-responsive subjects with mild     asthma.   "
186500|NCT00287820|"     The primary objective of the study is to assess whether chronic treatment with olanzapine     over a five-month period produces a significant increase in abnormalities in glucose levels.     The main secondary objective is to evaluate whether the increase in glucose levels and rate     of glucose abnormalities differs between Olanzapine and Risperidone during this treatment     period. Additional secondary objectives of the study are to investigate similar questions     with respect to glycohemoglobin, triglycerides and other measures of glucose and lipid     metabolism.      We hypothesize that Olanzapine will not be inferior to Risperidone in extent of increase in     the primary outcome measure of serum glucose, and secondary measures of glycohemoglobin,     insulin and lipids.   "
186529|NCT00288197|"     To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or     probable deep tissue fungal infections.   "
186466|NCT00287378|"     Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However,     in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic     allergic response, known as IgE-induced airway inflammation is what causes the increased     inflammation in response to ozone. To do this we will examine the response to ozone in a     group of asthmatics treated with omalizumab, a medicine available and approved for use in     people with asthma, or a placebo control. The placebo for this study is inert physiologic     saline (salt water) which contains no omalizumab. Both the omalizumab and the placebo will     be administered as an injection under the skin. Omalizumab, also called Xolair, is a     humanized monoclonal antibody, which means that it originally was produced in mice, then     genetically engineered to look more like human than mouse antibody. Omalizumab inactivates     IgE, a protein our own immune systems make as part of allergic reactions. The purpose of this     study is to test the hypothesis that omalizumab, by blocking this aspect of allergic     reactions, will decrease the number of inflammatory cells in the airway after ozone     challenge. We also hypothesize that omalizumab will decrease the effects of ozone on changes     in lung function, mucociliary clearance (a measure of how quickly mucus clears form the     airway) and airway reactivity. Airway reactivity is a measure of how sensitive the airways     are to a medication used to diagnose asthma, called methacholine. We will examine these as     additional information we can learn during the course of the study. This is a blinded study,     meaning that neither you nor the researchers know if you get the active drug or placebo, but     that information can be obtained if needed. The placebo is an injection of inert     physiological saline (salt water) which contains no omalizumab.   "
186467|NCT00287391|"     This study will investigate Gastroesophageal Reflux Disease (GERD)as a cause of sleep     disturbance. Patients with GERD may experience all or some of the following symptoms: stomach     acid or partially digested food re-entering the esophagus (which is sometimes referred to as     heartburn or regurgitation) and belching. Even very small, unnoticeable amounts of rising     stomach acid may cause patients to wake up during the night.      This study will also investigate the effect of Rabeprazole, (brand name Aciphex) on patients     with known insomnia. Rabeprazole is an FDA approved medication already marketed for the     treatment of GERD.   "
186468|NCT00287404|"     Many patients with type 2 diabetes have difficulty attaining cholesterol goals, partly due to     the recommendations for fasting measurements that may not be practical in the typical     clinical setting. Focus toward therapy is shifting toward non-fasting assessments but little     is known about the usefulness of this approach in diabetes, where postmeal cholesterol levels     are more abnormal. This is an observational study examining fasting and postmeal lipids     (cholesterol) in patients with type 2 diabetes using standard means and NMR.   "
186469|NCT00287417|"     The aim of the study is to evaluate the risk of Down syndrome during the first trimester of     the pregnancy. The risk assessment is evaluated using early ultrasound and maternal     biochemical markers.   "
186470|NCT00287430|"     We hypothesize that the anabolic effects of growth hormone (GH) will improve the clinical     status of patients with CF by improving lean body mass, osteopenia, muscle strength,     pulmonary function, and quality of life.      We will recruit 40 malnourished CF patients for this 12-month study. All 40 patients will be     treated with recombinant human growth hormone (rhGH). Each patient will serve as his/her own     control by obtaining medical records for 6 months to 1 year prior to study enrollment or by     completing 6 months of study without GH prior to being treated for 1 yr. with GH.   "
186491|NCT00287703|"     About 30% of patients with major depression are treatment resistant to pharmacological     treatment. In the search for new methods to treat depression a great interest has been put     into the use of electromagnetic fields. This study tests the hypothesis that ultra-weak     electromagnetic fields with a specific wave pattern (PEMF = pulsed electro magnetic fields)     can alleviate the symptoms of depression.   "
186471|NCT00287443|"     Our specific aims include:        1. AIM 1. Characterization of glucose tolerance, nutritional and clinical status,          socioeconomic status, family history of diabetes and genotype in Hispanic CF children          compared to Caucasian CF children. Each child will undergo a two-hour oral glucose          tolerance test and will be categorized by glucose tolerance according to standards set          forth by the 1998 CF Consensus Conference on Diabetes. Nutritional status will be          determined by three-day food journals and intake will be compared to energy needs          measured by indirect calorimetry. Socio-economic status will be calculated from reported          family income and medical insurance coverage. Genotyping will be done at the laboratory          of Dr. Arthur Beaudet at Baylor College of Medicine. Clinical status will be measured          using modified NIH scores. Family history for both type 1 and type 2 diabetes will be          obtained in Spanish by Dr.Vanderwel. This specific aim tests the hypothesis that glucose          intolerance /frank CF related diabetes occurs at a younger age in Hispanics than in          Caucasians with CF, and is correlated to family history of diabetes and clinical status.        2. AIM 2. Characterization of insulin secretion and insulin sensitivity. Previous studies          in adults have described peripheral insulin resistance as a major cause of CF related          diabetes, yet studies have not been conducted in children. Studies in adults and          children without CF suggest that insulin resistance occurs more frequently in Hispanics.          We will measure insulin secretion and insulin sensitivity using the frequently sampled          intravenous glucose tolerance test (IVGTT) and the minimal model analysis of Bergman, as          modified for children. This specific aim tests the hypothesis that Hispanic children          with CF have worse peripheral insulin resistance, but similar insulin secretion when          compared to Caucasian children with CF.        3. AIM 3. Quantification of post-absorptive gluconeogenesis and whole body protein          turnover. Total hepatic glucose production (HGP) will be measured using          [6,6-2H2]glucose. We will quantify gluconeogenesis by measurement of the incorporation          of 2H into the 2nd, 5th and 6th carbons of glucose following 2H20 administration method          of Landau). We will determine whole body protein turnover using the stable isotopes          [1-13C]leucine and will measure serum amino acid levels. This specific aim tests the          hypothesis that gluconeogenesis and whole body protein turnover are disproportionately          higher in Hispanic children and adolescents with CF than in Caucasian CF children.   "
186472|NCT00287456|"     We hypothesize use of the insulin pump will improve body weight, lean body mass, whole body     protein turnover, hepatic glucose production (HGP), and blood sugar control in CF patients     with impaired glucose tolerance or patients with CF related diabetes (CFRD). We further     hypothesize that HGP is also elevated in children/adolescents with type 1 diabetes and that     the insulin pump will result in decreased HGP.   "
186473|NCT00287469|"     The purpose of this study is to determine if a hepatitis E vaccine is safe and able to     prevent symptomatic liver disease due to the hepatitis E virus.   "
186474|NCT00287482|"     This is a pilot feasibility study being performed in women completing front-line treatment     for breast or ovarian cancer. It is being done to evaluate whether or not an herbal     combination known as Essiac (ESIAK) can improve the overall quality of life in these women as     they transition from active treatment to follow-up, also known as the quality of life in     transition. This information will be used to design a larger randomized trial.   "
186501|NCT00287833|"     This randomized phase I trial is studying the side effects and best dose of Bowman-Birk     inhibitor concentrate in preventing cancer in healthy men. Chemoprevention is the use of     certain drugs to keep cancer from forming, growing, or coming back. The use of Bowman-Birk     inhibitor concentrate may prevent cancer.   "
186502|NCT00287846|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see     how well it works in treating patients with recurrent or refractory aggressive fibromatosis.   "
186573|NCT00279370|"     This study will determine the safety of antidepressant use during pregnancy for both the     mother and the child.   "
186475|NCT00287495|"     Background:        -  Kaposi's sarcoma (KS) is a disease in which cancer cells are found in the tissues under          the skin or mucous membranes that line the mouth, nose, and anus. KS causes red or          purple patches (lesions) on the skin or mucous membranes and spreads to other organs in          the body, such as the lungs, liver, or intestinal tract.        -  BAY 43-9006 inhibits the activity of several proteins or protein receptors in cells that          are thought to be important to the progression of KS. Blocking these mechanisms may          cause KS to get better.      Objectives:        -  To learn about the toxicity and blood levels of BAY 43-9006 in people with KS who are          and are not taking the anti-retroviral drug ritonavir.        -  To look for evidence of a beneficial treatment effect of BAY 43-9006      Eligibility:        -  Adults with confirmed KS, both HIV-positive and HIV-negative.        -  Patients must have either 1) at least five measurable KS lesions with no previous local          therapy, or 2) other measurable non-skin disease that permits evaluation of a response          to treatment.      Design:        -  Patients are randomly assigned to a specific dose of BAY 43-9006. They take the drug by          mouth either once or twice daily, depending on their dose group, for up to 54 weeks.        -  Drug blood levels are determined after patients have been taking BAY 43-9006 for 1 to 2          weeks by blood collections immediately before the dose and at 1, 2, 4, 8, 12, 16 and 24          hours after the dose.        -  Patients are evaluated every 3 weeks with review of a medication diary, interview about          drug side effects, physical examination, and assessment of KS lesions.        -  KS lesions are photographed on entering the study and at other time points during the          study.        -  CD4 cell counts and HIV viral load are tested every 12 weeks.        -  Biopsies are done at the start of the study, on day 15, and if it appears that all of          the lesions have resolved.        -  Other procedures, such as CT or MRI scans, may be done if medically indicated.   "
186476|NCT00287508|"     To collect clinical outcome and device performance data on the FDA 510(k)-cleared Emboshield®     BareWire™ Rapid Exchange Embolic Protection System and FDA-approved Xact® Rapid Exchange     Carotid Stent System when used under commercial use conditions by a broad group of physicians     entering the study with differing carotid artery stenting experiences.   "
186477|NCT00287521|"     The purpose of this study is to determine whether a glaucoma therapy is safe and effective in     treating patients with open-angle glaucoma or ocular hypertension.   "
186478|NCT00287534|"     The purpose of this study is to determine the efficacy and tolerability of 3 years treatment     with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment     with tamoxifen in postmenopausal women with early breast cancer   "
186479|NCT00287547|"     The purpose of this study is to assess the safety, pharmacokinetics and clinical activity and     immunogenicity of BMS-188667 (CTLA4Ig) in subjects with psoriasis vulgaris   "
186480|NCT00287560|"     The purpose of the study is to determine wether a modified propofol preparation shows any     effect on the incidence of injection pain in children undergoing elective surgery under     general anesthesia.      Study hypothesis: The use of a modified propofol preparation will reduce the incidence of     injection pain in the study group.   "
186481|NCT00287573|"     The objective of this study is to evaluate the safety and effectiveness of the TAXUS Express2     Paclitaxel-Eluting Coronary Stent System as compared to brachytherapy in patients     experiencing in-stent restenosis.   "
186482|NCT00287586|"     As men grow older, their testosterone levels decrease with age. One-third of men, 70 years of     age or older, have low testosterone levels. It is known that short-term testosterone     replacement is safe, and can increase muscle strength and physical function, but the risks of     long-term testosterone replacement in older men with low testosterone levels are incompletely     understood.      Atherosclerosis is characterized by thickening of the artery walls, and the narrowing of the     blood vessels as cholesterol is deposited in the lining of the arteries. It is the major     cause of cardiovascular disease including ischemic heart disease (heart attacks) and stroke.     Although, historically, there has been a widespread perception that higher levels of     testosterone might increase the risk of atherosclerosis, the evidence from research does not     support this. In observational studies, higher testosterone levels have been correlated with     more favorable cardiovascular risk factors, and supplementation with testosterone to bring     older men into the normal range for healthy younger men appears to improve several     cardiovascular risk factors, and may slow the progression of atherosclerosis.      The primary purpose of this study is to look at the effects of testosterone replacement on     the progression of atherosclerosis in older men. This study is also being done to find out     whether replacement with testosterone in older men with low testosterone levels improves     their health-related quality of life.   "
186483|NCT00287599|"     The military is subject to traumatic wounds of various types and severity. Such wounds are     predisposed to infection because they 1) tend to be extensive and deep, 2) may affect areas     of normal carriage of potentially pathogenic bacteria in the gastrointestinal tract, upper     respiratory tract, and the female genital tract, 3) typically produce tissue damage, 4) may     introduce foreign bodies, 5) may interfere with local blood supply, 6) tend to produce     ischemia, edema and hemorrhage, 7) may be complicated by fractures or burns and 8) may lead     to shock and overwhelming of the body's systemic defenses. It will not always be possible in     the military setting to cleanse and debride the wound promptly and effectively or to promptly     provide surgery in the event of damage to vital structures. In the active military setting,     the probability of wound infection following trauma is relatively high. In the absence of     rapid identification of infecting flora and provision of information on antimicrobial     susceptibility, clinicians must resort to empiric therapy rather than a tailored therapy.     There is a tendency to use one of the top available agents that would likely be active     against the vast majority of bacteria. This leads to increases in antimicrobial resistance,     an important problem.      The investigators hypothesize that the use of molecular biology techniques will provide     identification of the microorganisms responsible for wound infection more rapidly and     accurately. The investigators will evaluate real-time PCR (polymerase chain reaction)     technique under this proposal. This procedure can be applied directly to material from the     wound without need for first growing the organisms. It can be used to define the total flora     of the wound within five hours. The investigators will first develop primers and probes that     will detect the various bacteria anticipated in a given wound in a certain location. These     primers and probes will be used in real-time PCR for rapid and accurate identification of the     wound flora. The information obtained with real-time PCR is quantitative so that one may     judge the relative importance of different isolates. The investigators will also use another     molecular approach, 16S rRNA gene cloning, and conventional cultures; these will provide     further information about the flora of various wounds. Definitive identification of anaerobes     can be provided quickly and that, along with information on usual antimicrobial     susceptibility patterns, can be life-saving or shorten the course of the infection     considerably.   "
186484|NCT00287612|"     This study compares complete dissection of the tissue around the lower esophagus to no     dissection of these tissues during laparoscopic fundoplication in children.   "
186503|NCT00287859|"     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Chemotherapy drugs may have different effects in patients who have a poor performance status.      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in     treating patients with progressive or recurrent ovarian epithelial, fallopian tube, or     primary peritoneal cavity cancer with a poor performance status.   "
186577|NCT00279435|"     The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and     immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior     visilizumab study.   "
186485|NCT00287625|"     Chronic obstructive pulmonary disease (COPD) is a disease state characterized by airflow     limitation that is not fully reversible. Acute exacerbation of COPD (AECOPD) with increasing     symptoms like dyspnea, cough and sputum is the natural history of the disease and incurs     significant burden to our health care system. In Hong Kong, COPD was the 5th leading cause of     death, and accounted for at least 4% of all public hospital acute admissions in 2003.     Previous studies have shown that pulmonary function and quality of life were adversely     affected by frequent exacerbations. Strategies to decrease the heavy use of health care     resources is urgently needed for the benefits of the patients and the society.      Pulmonary rehabilitation programme (PRP) is a multidisciplinary programme of care for     patients with chronic respiratory impairment. In COPD patients, the programme can be tailored     individually and can optimize each patient's physical and social performance and autonomy.     Previous studies on patients with stable COPD found that a PRP including education and     physical training could lead to statistically significant and clinically meaningful     improvements in health related quality of life and exercise capacity.      COPD patients who just have experienced an episode of acute exacerbations are at high risk of     developing another attack. There has been only one randomized controlled study looking at the     effect of out-patient PRP for patients immediately after an exacerbation. It has shown that     PRP immediately after an exacerbation was safe and improved the exercise capacity and the     quality of life at 3 months. However, the follow up duration of the study was short and thus     the effect of rehabilitation on recurrent exacerbations and hospitalizations is not assessed     and this information is important.      The investigators would thus like perform a randomized controlled trial to assess if a short     course (for 6 weeks) out-patient PRP for patients admitted to acute hospital for AECOPD could     have a positive impact on the patients by decreasing their health care resources utilization     (recurrent COPD exacerbations, hospitalizations and accident and emergency department [AED]     attendance) and improving the quality of life of the patients over a period of 1 year.     Patients will be randomized to either a control group or PRP intervention group.      It is hope that the information generated from this study will be able to give a guide to     whether short course PRP is effective for the patient (in terms of quality of life) and the     health care system (in terms of health care utilization).   "
186486|NCT00287638|"     Patients with obstructive sleep apnoea (OSA) have repetitive episodes of partial or complete     upper airway obstruction during sleep. This leads to sleep fragmentation and symptoms like     excessive daytime sleepiness and impaired psychosocial well-being. More evidence now     suggested OSA is associated with cardiovascular diseases like hypertension, myocardial     infarction, pulmonary hypertension and stroke.      The upper airway structure and function are altered in OSA. Some studies suggested that an     increase in the levels of systemic biomarkers of inflammation and oxidative stress in     patients with OSA. So far, there is only very limited data on non-invasive monitoring of     inflammation involved in the upper airway of OSA patients. The inflammatory mechanisms     involved in the upper airway may give some insights to the systemic effect, like     cardiovascular complications, of OSA.      Measurement of the constituents of exhaled breath and exhaled breath condensate (EBC) is a     non-invasive method to assess the degree of inflammation of the airway. Exhaled nitric oxide     (eNO) can be measured with the subject exhaling to a mouthpiece connected to a machine     measuring real-time eNO level. With the subject exhaling to a cooling unit, EBC can be     collected as liquid is formed as a result of condensation.      This study will assess the eNO in exhaled breath, oxidative stress marker (8-isoprostane) and     cellular inflammatory markers (eotaxin, monocyted derived chemokine, growth related oncogene-     alpha, monocyte chemoattractant protein-1) in the EBC and blood of OSA patients before and     after 1 night and 3 months of continuous positive airway pressure treatment.   "
186487|NCT00287651|"     Diabetic Retinopathy is the leading cause of blindness in the world. Previous studies have     documented beneficial effects of physiologic administration of pulsatile insulin on a variety     of diabetic complications such as nephropathy, hypertension, glycemic control, etc. Similar     pathogenetic mechanisms have been postulated for diabetic retinal disease. This study     examines the effect of pulsatile insulin on patients with varying stages of diabetic retinal     disease.   "
186488|NCT00287664|"     Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of     patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents     (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous     studies are pilot studies and they are not able to give information about an improvement in     survival. This comparative randomized study was delineated to test the efficacy of     terlipressin on survival.   "
186489|NCT00287677|"     Concomitant administration of recombinant human growth hormone (rhGH) may boost the expansion     of immune reconstitution and broaden specific T cell responses not achievable by vaccination     alone. The main objective of that study is to test the validity of this hypothesis with     vaccines which are routinely administered to HIV-1 patients(tetanus toxoid and hepatitis A     virus vaccines) in order to, if proven of value, use this strategy of HIV vaccination in the     near future. This is a pilot, randomized, clinical open label study aimed to investigate     thymic functionality and the HIV-specific responses after administration of rhGH in HIV-1     infected patients in highly active antiretroviral therapy (HAART) regimen.   "
186490|NCT00287690|"     The aim of this study is to investigate the effect of genistein administration on coronary     arteries in humans. We will measure the size of a coronary artery and the speed and amount of     blood flow in response after subjects have ingested Supro® drinks (a soy protein drink     containing genistein).   "
186497|NCT00287781|"     Migraine headaches have previously been shown to be responsive to intranasal lidocaine in a     small study. Using a nebulizer to administer the drug would improve the feasibility of using     the treatment. It would also spare the patient narcotics with their attendant side effects.     Because of the potential for placebo effect a placebo control is necessary in this study.   "
186498|NCT00287794|"     As one of the characteristic clinical features of the patients with rheumatoid arthritis, the     unique character of the patients, somewhat difficult to be persuaded but theoretical, has     long been pointed out. The investigators hypothesized that this unique character might be due     to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique     biochemical disease activities. The investigators test (1) the sleep quality of the patients     and draw some characteristic features, and (2) investigated the connection between unique     biochemical changes such as the increase of c-fos or wee-1.   "
186499|NCT00287807|"     Self-monitoring of blood glucose (SMBG) is one of the important instruments in diabetes     management. Most patients with type 1 diabetes and patients with type 2 using insulin,     frequently measure their blood glucose in case of possible hypoglycemia, but also to evaluate     the insulin treatment and get information about how to change the insulin regimen, if     necessary. Without SMBG it is almost impossible to achieve this goal.      The purpose of this study is to determine if self-monitoring in patients with type 2 diabetes     not using insulin results in better glycemic control.   "
186597|NCT00279695|"     The objective of this research program is to improve diagnosis and treatment monitoring of     ophthalmic disease by improving diagnostic ultrasound techniques. The program explores the     use of novel signal and imaging processing techniques towards this end.   "
186506|NCT00287898|"     RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is     not yet known whether genetic counseling by telephone is more effective than standard     (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.      PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to     see how well it works compared to standard (in-person) genetic counseling in women at risk of     carrying the BRCA1 or BRCA2 mutation.   "
186507|NCT00287911|"     RATIONALE: Drugs used in chemotherapy, such as topotecan and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Internal radiation     uses radioactive material placed directly into or near a tumor to kill tumor cells. Topotecan     and cisplatin may make tumor cells more sensitive to radiation therapy. Giving topotecan and     cisplatin together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when     given together with cisplatin and radiation therapy in treating patients with advanced     cervical cancer.   "
186508|NCT00287924|"     RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well high-dose methotrexate works in treating     young patients with residual ependymoma.   "
186509|NCT00287937|"     This phase I trial is studying the side effects and best dose of vorinostat when given     together with paclitaxel and carboplatin in treating patients with advanced or refractory     solid tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving vorinostat together with paclitaxel and carboplatin may     kill more tumor cells   "
186716|NCT00281528|"     This is a multi-center, open-label, randomized Phase II study in previously untreated     patients with metastatic breast cancer to evaluate the antitumor activity and safety of     weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly     infusion. All patients will also receive concurrent bevacizumab.   "
186510|NCT00287950|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.     Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain     after surgery. Sometimes, the tumor may not need any treatment until it progresses. In this     case, observation may be sufficient.      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together     with surgery and radiation therapy works in treating infants with neuroblastoma.   "
186511|NCT00287963|"     RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when     given together with vinorelbine in treating patients with recurrent lung cancer.   "
186512|NCT00287976|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well irinotecan works in treating young patients     with refractory or recurrent hepatoblastoma.   "
186513|NCT00287989|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving erlotinib together with paclitaxel and carboplatin may     kill more tumor cells.      PURPOSE: This randomized phase II trial is studying two different doses of erlotinib when     given together with paclitaxel and carboplatin to compare how well they work in treating     patients with stage III, stage IV, or recurrent non-small cell lung cancer.   "
186514|NCT00288002|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, docetaxel, and     capecitabine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth     in different ways. Some find tumor cells and kill them or carry tumor-killing substances to     them. Others interfere with the ability of tumor cells to grow and spread. Giving combination     chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller     and reduce the amount of normal tissue that needs to be removed. Giving monoclonal antibodies     after surgery may kill any tumor cells that remain after surgery. It is not yet known whether     combination chemotherapy is more effective with or without capecitabine and/or trastuzumab in     treating breast cancer.      PURPOSE: This randomized phase III trial is studying epirubicin, cyclophosphamide, and     docetaxel to compare how well they work with or without capecitabine and/or trastuzumab     before surgery in treating women with stage I, stage II, or stage III breast cancer.   "
186515|NCT00288015|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with     angiosarcoma.   "
186516|NCT00288028|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Giving bortezomib after an autologous peripheral blood stem cell     transplant may stop the growth of any cancer cells that remain after transplant.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib in     treating patients with multiple myeloma who have undergone an autologous peripheral blood     stem cell transplant.   "
186611|NCT00279877|"     Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty     for the treatment of painful, osteoporotic vertebral compression fractures.   "
186517|NCT00288041|"     This phase II trial is studying how well giving bortezomib together with paclitaxel and     carboplatin works in treating patients with metastatic melanoma. Bortezomib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may     help paclitaxel and carboplatin kill more tumor cells by making tumor cells more sensitive to     these drugs   "
186518|NCT00288054|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find     tumor cells and kill them or carry tumor-killing substances to them. Others interfere with     the ability of tumor cells to grow and spread. Radiation therapy uses high-energy x-rays to     kill tumor cells. Giving docetaxel and cetuximab together with radiation therapy may kill     more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when     given together with cetuximab and radiation therapy in treating patients with stage III     non-small cell lung cancer.   "
186519|NCT00288067|"     This phase I/II trial is studying the side effects and best dose of fenretinide and to see     how well it works when given together with rituximab in treating patients with B-cell     non-Hodgkin lymphoma. Drugs used in chemotherapy, such as fenretinide, work in different ways     to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others     interfere with the ability of cancer cells to grow and spread. Giving fenretinide together     with rituximab may kill more cancer cells.   "
186547|NCT00279032|"     The findings from preclinical animal models confirm the peripheral     anti-inflammatory/analgesic activity of GW406381 and also suggest contribution of a central     site of action to the anti-hyperalgesic efficacy that may not be shared by other COX-2     inhibitors. A central action is consistent with distribution of GW406381 into the CNS in     animals. Furthermore, preliminary data from a positron emission tomography study in which 6     healthy male volunteers received a tracer dose of 11C labelled GW406381 indicate that     GW406381 is rapidly absorbed into the central nervous system in man.   "
186717|NCT00281541|"     A study with YM155 for the treatment of unresectable stage III or metastatic stage IV     melanoma.   "
186520|NCT00288080|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using     drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer     by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays     to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. It is not yet known whether giving hormone therapy and radiation therapy     together with chemotherapy is more effective than giving hormone therapy together with     radiation therapy in treating prostate cancer.      PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy     followed by docetaxel and prednisone to see how well it works compared to hormone therapy and     radiation therapy in treating patients with localized prostate cancer.   "
186521|NCT00288093|"     This phase I trial is studying the side effects and best dose of 3-AP when given together     with radiation therapy in treating patients with stage III pancreatic cancer that cannot be     removed by surgery.      3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 3-AP may make tumor     cells more sensitive to radiation therapy. Giving 3-AP together with radiation therapy may     kill more tumor cells.   "
186522|NCT00288106|"     RATIONALE: Learning about the long-term effects of chemoprevention drugs, such as     finasteride, in patients with prostate cancer may help doctors plan better treatment and     follow-up care.      PURPOSE: This clinical trial is following patients who were diagnosed with prostate cancer     while undergoing treatment with either finasteride or a placebo on the Prostate Cancer     Prevention Trial (PCPT).   "
186523|NCT00288119|"     This is a multi-center study whose aim is to define the epidemiology and genetics of     Barrett's esophagus and adenocarcinoma. The researchers have studied families affected with     Barrett's esophagus and esophageal adenocarcinoma, a specific type of cancer of the     esophagus. They have found that Barrett's and esophageal cancer occur at a younger age in     these families suggesting that familial Barrett's esophagus is a genetically inherited     disease.   "
186524|NCT00288132|"     The American Diabetes Association clinical care guidelines stress the importance of metabolic     control to prevent complications and improve quality of life for persons with diabetes.     Unfortunately, these guidelines have not had widespread acceptance into clinical practice.     Therefore, we propose translational research to evaluate telemedicine technology using     interactive video conferencing (Diabetes TeleCare) as a novel means to increase the     availability of health professionals in rural communities for the effective delivery of a     diabetes self-management education program and as a means to provide retinal screenings in     the primary care setting.   "
186525|NCT00288145|"     The project is designed to test the effectiveness of a multilevel worksite wellness program,     based in Rhode Island and nearby neighboring states to impact employee weight, dietary intake     and physical activity, compared to an attention placebo condition.   "
186526|NCT00288158|"     The purpose of this study is to examine the consequences of lowering serum uric acid in     pre-hypertensive, obese adolescents pathways involved with how uric acid mediated     hypertension and renal disease. The specific aims are:        1. Test the hypothesis that lowering uric acid will improve endothelial function.        2. Test the hypothesis that lowering uric acid will reduce plasma renin activity and serum          angiotensin II levels.        3. Test the hypothesis that lowering uric acid will reduce markers of inflammation   "
186527|NCT00288171|"     To test the hypothesis that lowering serum uric acid will ameliorate hypertension in children     after renal transplantation.   "
186528|NCT00288184|"     The study is a randomized, double-blinded, placebo controlled, crossover trial of allopurinol     for the treatment of children with newly diagnosed essential hypertension.   "
186530|NCT00288210|"     The incidence of stent restenosis in the setting of primary angioplasty is particularly high,     reaching a rate of 27% In the last years the introduction of drug-eluting stents has     drastically reduced the incidence of restenosis in patients not requiring urgent     revascularization. Whether drug-eluting stenting might constitute the new optimal therapy for     patients with an acute myocardial infarction is unknown. To be able to answer this question,     we designed a randomized trial in which patients with an acute myocardial infarction eligible     for treatment with primary angioplasty and abciximab were randomized to receive either a     rapamicine-eluting stent or a conventional bare stent.   "
186531|NCT00288223|"     Study objectives:        -  to document the clinical efficacy of telithromycin(800 mg per day for 5 days) at Test Of          the Cure (TOC)visit (D12-D19), in acute exacerbation of chronic bronchitis.        -  to assess the long-term clinical efficacy of telithromycin by telephone at D25-D35 (V3)        -  to assess the safety of telithromycin   "
186532|NCT00288236|"     Primary: Effect on HbA1c over 48 weeks in insulin-treated patients with type 2 diabetes      Secondary: Effect on glucose, total daily insulin dose, body weight, waist circumference,     HDL-cholesterol, triglycerides - Safety, tolerability   "
186533|NCT00278850|"     The purpose of this study is to investigate the efficacy of an educational seminar series for     women with vulvar vestibulitis syndrome (VVS).   "
186534|NCT00278863|"     A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of     age and older. In addition, patient delay in seeking care for symptoms results in diagnosis     at a more advanced stage than that seen in younger individuals. However, clinical trials on     gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which     have been reported to have clinically significant response rates and survival with mild or     negligible toxicities, have been widely used for the patients with AGC. However, few studies     have been conducted in elderly patients.   "
186548|NCT00279045|"     The study will compare and evaluate the effects of long-term treatment of monotherapy with     rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of     glycemic control in patients with recently diagnosed type 2 diabetes mellitus.   "
186718|NCT00281554|"     This study is designed to determine the safety of RSD1235 in patients with atrial     fibrillation.   "
186719|NCT00281567|"     Comparison of lung function response between tiotropium inhalation solution and Spiriva     HandiHaler.   "
186535|NCT00278876|"     The presence of c-kit mutation is an independent poor prognostic factor for relapse in     addition to large size (> 5 cm) and high mitotic rate (> 5/50 high power field [HPF]) in     localized gastrointestinal stromal tumor (GIST) patients who underwent complete surgical     resection. In addition, the localized GIST which had exon 11 c-kit mutation and features of     high-risk for relapse according to National Institute of Health (NIH) consensus guideline     (tumor size > 10 cm or mitotic count > 10/50 HPF) also have high-risk of relapse. Until     recently, there has been no effective therapy for advanced, unresectable GISTs. However, a     new agent, imatinib mesylate, has shown promise in the metastatic setting, and c-kit exon 11     mutation is the strongest prognostic factor for better response and survival. It is     reasonable to try imatinib in an earlier and minimal residual status especially for patients     at higher risk of relapse and a higher probability of response to imatinib.   "
186536|NCT00278889|"     The primary purpose of this study is to compare the efficacy of AZD2171 in combination with     FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line     treatment of patients with metastatic colorectal cancer   "
186537|NCT00278902|"     This is a Phase 1 study during which patients with advanced solid tumors will receive     investigational study drug ARRY-334543.      This study has 2 parts. In the first part, patients will receive increasing doses of study     drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible     that will not cause unacceptable side effects. Approximately 70 patients from the US and     Canada will be enrolled in Part 1 (Completed).      In the second part of the study, patients will receive the best dose(s) and schedule(s) of     study drug determined from the first part of the study and will be followed to see what side     effects the study drug causes and what effectiveness it has, if any, in treating the cancer.     Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).   "
186538|NCT00278915|"     The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a     study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty     (early puberty) in girls with McCune-Albright syndrome (MAS).   "
186539|NCT00278928|"     This will be a prospective, randomized trial to determine if differences exist in the     tolerance of lipid injectable emulsions in the neonatal intensive care unit (NICU). Lipid     injectable emulsions are an essential nutrient for neonatal growth and development.     Traditionally, lipid injectable emulsions have been commercially available in sterile glass     bottles, but in April of 2004, a new container was introduced as a sterile plastic bag. In     January, 2005, NICU personnel observed what appeared to be a higher than usual incidence of     hypertriglyceridemia. Upon further laboratory investigation of the lipid injectable emulsions     stored in glass bottles versus those in plastic, significant differences were noted in the     population of large-diameter fat globules by globule size analysis, reflective of a less     stable emulsion in plastic. The United States Pharmacopeia (USP) which sets the standards for     drug purity and safety in the U.S., and whose drug monographs are enforceable by the FDA, has     proposed to limit this large diameter fat globule population to a volume-weighted percent fat     greater than five micrometers or PFAT5 to be less than 0.05% of the total lipid     concentration. (At the present time, the USP monograph is not officially recognized, but is     on track for adoption in 2006.) Our preliminary analyses of four lots of 20% lipid injectable     emulsion packaged in glass to have a PFAT5 of 0.003±0.0008%, compared to an approximate     55-fold increase in the large-diameter fat globule population or 0.166±0.016% for an equal     number of products packaged in plastic. We hypothesize this difference may explain the recent     clinical observations. We will compare the incidence of hypertriglyceridemia in neonates     between lipids packaged in glass versus those in plastic. The study will attempt to discern     whether the differences in packaging influence the stability and subsequent tolerance of     lipid injectable emulsions.   "
186540|NCT00278941|"     The purpose of this study is to determine safety & efficacy of SEROQUEL SR™ in the treatment     of major depressive disorder compared to placebo & to evaluate quality of sleep, overall     quality of life, and effect, if any, on anxiety and satisfaction PLEASE NOTE: Seroquel SR and     Seroquel XR refer to the same formulation. The SR designation was changed to XR after     consultation with FDA.   "
186612|NCT00279890|"     SR-01 may reduce facial redness. it is a topically applied product. The agent will be applied     to local skin areas of subjects with red facial skin to assess affect, and then applied to     the whole face to assess efficacy and safety   "
186541|NCT00278954|"     The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food     and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial     infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The     secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine     if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intact Immunoglobulin     G (IgG) in subjects with PID.   "
186542|NCT00278967|"     To compare the safety and efficacy of 2 different bowel cleansing preparations prior to     colonoscopy in adult subjects.   "
186543|NCT00278980|"     The aim of the study is to investigate the effect of C-peptide administration on nerve     function in patients with type 1 diabetes and peripheral sensory neuropathy.   "
186544|NCT00278993|"     This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patients     with hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastatic     disease and who have had prior anti-androgen therapy. The study will further explore the     efficacy of E7389 by enrollment of patients into two strata: those who have had no prior     systemic chemotherapy for their disease (except for mitoxantrone and estramustine), and those     who failed no more than one previous chemotherapeutic regimen with tubulin-binding agents     such as docetaxel.   "
186545|NCT00279006|"     This study will evaluate the 3 drug-eluting stents presently marketed for intervention in the     coronary artery with respect to the complications that may occur in case it becomes necessary     to retract the stent during the intervention. It has been noted that stents carrying a drug     for local application may be more difficult to retract than the more smooth bare metal     stents.   "
186546|NCT00279019|"     GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being     developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long     duration of action of GSK233705 when administered via inhalation in animal models supports     the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary     disease.      GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being     developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long     duration of action of GSK233705 when administered via inhalation in animal models supports     the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary     disease.   "
186602|NCT00279760|"     This randomized, double-blind, placebo controlled, parallel and multiple dose study provided     safety, preliminary efficacy, and immunogenicity information about the use of BMS-188667 and     BMS-224818 in subjects with RA   "
186603|NCT00279773|"     The primary objective is to determine the maximum tolerated dose (MTD), dose limiting     toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid     leukemia (AML).   "
186549|NCT00279058|"     Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized,     this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy     represents an approach to treatment based on the immune response to cancer antigens.      The principal objective of the study is to identify whether a dendritic cell-based vaccine     can increase the moderate therapeutic effect of bolus high dose IL-2 in patients with     metastatic melanoma. For this purpose,patients with metastatic melanoma who have a certain     blood type (HLA-A201+) will be treated systemically with high dose IL-2. In one group of     patients, the IL-2 will be preceded by three doses of autologous dendritic cell pulsed with     melanoma antigens appropriate for their blood type. Two cycles of three DC vaccines will be     administered every 14 days by intra-lymph node injections, followed by high dose IL-2     treatment. Responding patients will receive additional DC vaccines at 1 month and 2 months     intervals.      In a second group, patients will receive the standard high dose IL-2 protocol within a     comparable period of time.      Each group will include 12 patients.      A complete evaluation of evaluable lesions will be performed prior to accrual, after initial     3 DC vaccines, six weeks after first IL-2 treatment, after a total of 6 DC vaccines and 6     weeks after second cycle of IL-2 treatment.   "
186550|NCT00279071|"     Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary     inertia.      A randomized controlled trial including 150 pregnant women Acupuncture has become a natural     part of the range of obstetric treatments offered in danish delivery wards, but there is only     little evidence to the effect of the acupuncture.      The women are randomized into to groups.        1. Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure)        2. No treatment      The women will be asked in case beginning signs of inertia, if they want to parcipitate in     the trial.      Inclusion criteria:        1. Normal pregnancy        2. In labour (orificium < 8 cm), 37th week or thereafter        3. Ruptured membranes        4. Primary or secondary inertia      The women will just before randomization be vaginally explored and fetal heart monitored. The     meassure of effect happens two hours after randomization.      The midwife who measures the effect, is blinded to the treatment or lack of, and also on the     including exploration.      Secondary effect meassures: length of labour, use of oxytocin and number of contracions     pr/min meassured twice:      1. before the randomization and again 1 hour after randomization.   "
186551|NCT00279084|"     In type 2 diabetics, progression from chronic kidney disease to end stage renal disease may     be slowed down by therapeutic interventions as angiotensin converting enzyme inhibitors use,     control of high blood pressure and proteinuria, control of hyperglycaemia, protein intake     restriction, smoking cessation.      Correcting anaemia in these patients may prevent impairment of renal function. International     guidelines indicate that haemoglobin level has to be of 110 g/L in these patients. We conduct     an interventional randomized trial to evaluate the potential benefit of an haemoglobin level     of 130 g/L in patients with type 2 diabetes and with a chronic kidney disease defined by a     Cockcroft's creatinine clearance of 25 - 60 ml/min.   "
186552|NCT00279097|"     The purpose of this study is to evaluate changes in intracranial pressure (ICP) during or     immediately following high frequency chest wall oscillation (HFCWO) treatment with the Vest™     in neurosurgical subjects.   "
186553|NCT00279110|"     The purpose of this study is to determine whether providing directly administered     antiretroviral therapy to HIV-infected who receive methadone therapy leads to better     treatment outcomes than if they take HIV medications on their own.   "
186554|NCT00279123|"     Endoscopic treatment of bleeding peptic ulcers is effective to prevent rebleeding. Adjuvant     medical treatment to increase gastric pH may further decrease rebleeding. Recent studies on     potent acid suppression by proton pump inhibitors (PPI) demonstrated the efficacy in     preventing rebleeding. Lau demonstrated that high dose intravenous infusion of omeprazole     decreased rebleeding in peptic ulcers with stigmata of recent hemorrhage.      There is little data regarding the effect of pantoprazole on bleeding peptic ulcers.     Furthermore, the optimal dose of PPI is unknown. Few studies have included measurement of     gastric pH in addition to clinical outcome.      This study compares the effect of two doses of intravenous pantoprazole with no acid     suppression in bleeding peptic ulcers after endoscopic therapy. In addition to the usual     clinical endpoints, gastric pH is monitored to study the relation of pH elevation and the     clinical outcome.   "
186555|NCT00279136|"     Asthma and COPD are characterized by airway narrowing. The most potent, physiological     mechanism leading to bronchodilation is taking a deep inspiration. This protects healthy     subjects against bronchoconstrictive stimuli, and reverses pre-existing bronchoconstriction.     However, the deep breath-induced bronchoprotection and -bronchodilation is impaired in     asthma. We questioned whether this is specific for asthma (in comparison to COPD), and     whether this is associated with bronchial inflammation and -remodelling. The study is a     two-groups comparison, of physiological and pathological disease markers, obtained by     methacholine challenges, monitoring airways resistance, and by taking bronchial biopsies.   "
186556|NCT00279149|"     The objective is to evaluate decision making of i.v. tPA treatment in acute stroke within 3     hours of symptom onset either remotely via videoconferencing system (investigational arm)     beginning of treatment on-site and then transfer to stroke unit vs. decision after immediate     transfer to stroke unit (usual care arm). Ten remote hospitals are connected to the BICHAT     stroke unit. All patients will have stroke unit care at BICHAT hospital. Primary end-point is     rankin 0-1 at 3 months.   "
186557|NCT00279162|"     Patients will receive either a gel containing both calcipotriene plus betamethasone or gel     with no active ingredients as treatment for their scalp psoriasis for 8 weeks. After this     time all patients will receive the gel containing both calcipotriene and betamethasone for 44     weeks. In addition, patients will receive an ointment containing both calcipotriene plus     betamethasone as treatment for their psoriasis of the trunk and limbs for 52 weeks.      The objective is to study the short-term efficacy of the gel, and the short and long-term     safety of the gel and the ointment.   "
186633|NCT00280436|"     This study is designed to find the optimal (best) doses of GW679769 that promote sleep onset     and maintain sleep during two consecutive nights of dosing without significant next-day     thinking impairment and drowsiness in subjects with primary insomnia.   "
186720|NCT00281580|"     To demonstrate that Micardis and Norvasc when used together are more effective at lowering     blood pre ssure.   "
186558|NCT00279175|"     Impaired contractile function after a heart attack of the heart is a major cause of heart     failure limiting quality of life and prognosis, which cannot be prevented even with optimal     standard therapy, including immediate balloon/stent dilation of the infarct vessel.      The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into     the infarct vessel (after successful reperfusion therapy) may improve left ventricular     contractile function compared to placebo therapy. After bone marrow aspiration progenitor     cells are enriched via a centrifugation method.   "
186559|NCT00279188|"     The long-term course of asthma shows variable outcome with regard to the incidence of     exacerbations and the decline of lung function over time. The present study aimed:        1. to investigate whether asthma management additionally guided by the degree of bronchial          hyperresponsiveness leads to a better outcome        2. to examine the predictors among clinical and inflammatory disease markers of the          long-term decline in lung function   "
186560|NCT00279201|"     This study will compare insulin lispro low mixture [LM] and insulin glargine both in     combination with the patient's oral diabetes medicines, for their ability to control blood     sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with     regard to the length of time that the overall blood sugar can be controlled.      This study will also determine whether the safety of insulin lispro LM and any side effects     that might be associated with it are different from those observed with insulin glargine,     both in combination with the patient's oral diabetes medications.      The addendum study (Intensification Addendum) will compare how different insulin treatments     work to control blood sugar in patients whose diabetes could not be controlled by either     insulin lispro LM or insulin glargine.   "
186561|NCT00279214|"     The study will evaluate the vasopressor requirement, hemodynamic response and measures of     tissue perfusion in patients with septic shock receiving an infusion of drotrecogin alfa     (activated) compared to patients not receiving drotrecogin alfa (activated).   "
186562|NCT00279227|"     We sight to evaluate whether patients with coronary artery disease (CAD) have more epicardial     fat than patients without CAD, which would suggest that epicardial fat may be more than an     “innocent bystander” and be actively involved in the disease process. Its role as a modulator     of vascular response and myocardial function could potentially lead to new areas of cardiac     research. We also sight to evaluate whether epicardial fat from patients with CAD releases     more adipokines than subcutaneous fat from these patients which could prompt studies into the     differential regulation of adipokine secretion in this tissue. Thus for e.g., the use of     thiazolidinediones (glitazones), statins, ARBs or other compounds that can specifically     modulate adipokine secretion could be explored to determine their benefit in ameliorating the     effects attributable to increased epicardial fat.   "
186563|NCT00279240|"     Three year prospective randomised controlled trial in IGT subjects to study the effect of     metformin and lifestyle modification in preventing the conversion to diabetes   "
186574|NCT00279383|"     OSHES (= Observational Study on Hemostasis in Surgery) is a non interventional register     settled in Italy with the purpose of collecting data on 800 patients intra-operatively     treated with hemostatic supporting agents/techniques in addition to the standard surgical     procedures in 40 surgical wards. The availability of these data will allow for a better     understanding of the therapeutic needs in the area of hemostatic supporting     agents/techniques.   "
202154|NCT00487071|"     The aim of this pilot study is to evaluate the efficacy and safety of anal fistula plug in     the management of high-type anal fistulae among Hong Kong Chinese patients.   "
186564|NCT00279253|"     Background Clonidine, a derivate of Imidazol, is an antihypertensive drug. It acts by     stimulating adrenergic receptors on nerves in the brain and Imidazol-receptors. As a result,     clonidine slows the heart rate and reduces blood pressure. Clonidine was approved by the FDA     in 1974 and is registered in Austria with the brand name “Catapresan”.      Alpha2 adrenergic agonists are nowadays used topically as eye drops in glaucoma treatment. In     addition to their known effect of lowering intraocular pressure, alpha2 adrenoceptor agonists     are neuroprotective. Brimonidine, which is the most commonly used topical alpha-2 agonist, is     currently on the market for treatment of glaucoma and is effective in reducing intraocular     pressure. It has, however, been shown that brimonidine is a very potent vasoconstrictor in     the ciliary body thus reducing aqueous humor production. Little is, however, known about     potential vasoconstrictor effects of brimonidine in the posterior pole of the eye. This is of     clinical importance, because optic nerve head ischemia appears to contribute to glaucoma     pathophysiology. Direct investigation of the ocular hemodynamic effects of brimonidine is,     however, difficult, because lowering intraocular pressure with brimonidine may confound the     results due to the concomitant change in ocular perfusion pressure.      The aim of the present study is to assess the effect of intravenous clonidine as model drug     of alpha agonists on ocular blood flow and IOP in healthy humans.      Study objectives:      To investigate effects of clonidine on ocular blood flow and intraocular pressure.   "
186565|NCT00279266|"     This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in     patients with diabetic peripheral neuropathy.   "
186566|NCT00279279|"     The purpose of this study is to test specific device programming in patients without a     previous history of a life-threatening, abnormally fast heartbeat who are implanted with a     Medtronic ICD (Implantable Cardioconverter Defibrillator) or ICD with CRT (Cardiac     Resynchronozation Therapy) device. The information learned from this study could be used to     guide physicians in future ICD or CRT device programming.   "
186567|NCT00279292|"     This is a clinical trial to determine more effective methods of controlling the pain in     pancreatic cancer. Although narcotic pain medication are effective, they have many side     effects and are underutilized due to social stigma and fear of addiction. Celiac plexus     neurolysis is a nerve block procedure that has been shown to be effective in uncontrolled     clinical trials. We hypothesized that celiac plexus neurolysis plus pain medication will be     more effective and have fewer side effects than pain medication alone. We are evaluating the     effectiveness of this standard pain medications with or without celiac plexus neurolysis in a     randomized controlled trial. One half of the participants will receive pain medications only     and the other half will receive pain medications plus neurolysis, delivered via an endoscopic     ultrasound device placed in the stomach.   "
186649|NCT00280644|"     Study objectives:        -  To provide more insight on the modulation of inflammation and matrix degrading factors          in serum and urine by leflunomide in early , active patients with RA and to validate the          sensitivity of DEMRI (Dynamic Enhanced Magnetic Resonance Imaging) in detecting          inflammatory changes in active RA in response to treatment with leflunomide        -  Effect of leflunomide therapy on physical function improvement and Quality of life   "
186650|NCT00280657|"     The purpose of the study is to determine safety and efficacy of an oral contraceptive in     treating acne papulopustulosa.   "
193787|NCT00381316|"     The study is designed to determine whether a dual isotope protocol is equivalent to a single     isotope in the diagnosis of myocardial ischemia and infarction using MYOVIEW SPECT imaging.   "
186568|NCT00279305|"     Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the     insulin-producing beta cells in the pancreas. Without these beta cells, the body cannot     maintain proper blood glucose levels in response to daily activities such as eating or     exercise. With fewer insulin producing cells blood glucose increases, causing hunger, thirst,     and unexplained weight loss. By the time these symptoms develop, 80-90% of a person's beta     cells have already been destroyed. However, this also means that between 10-20% of these     cells remain that continue to produce insulin.      Scientists have learned that two types of immune cells, B cells and T cells, are involved in     causing type 1 diabetes. T cells are responsible for attacking and destroying the beta cells     that make insulin. Although they don't attack insulin producing cells, B cells may be what     trigger the T cells to attack.      This study will investigate the use of rituximab to see if it can help lower the number of     immune B cells thereby preventing the destruction of any remaining insulin producing beta     cells that remain at diagnosis. Rituximab is approved by the Food and Drug Administration     (FDA) for the treatment of a condition called B-lymphocyte lymphoma. Its effects on the     immune system are well understood through its use in organ transplantation. Research has     shown that rituximab might be helpful in treating other conditions caused by T cells and B     cells, including type 1 diabetes. The goal of this study is to find out if rituximab can     preserve residual insulin secretion and prevent further beta cell destruction in type 1     diabetes.   "
186569|NCT00279318|"     The long-term goal of the TEDDY study is the identification of infectious agents, dietary     factors, or other environmental agents, including psychosocial factors which trigger T1DM in     genetically susceptible individuals or which protect against the disease. Identification of     such factors will lead to a better understanding of disease pathogenesis and result in new     strategies to prevent, delay or reverse T1DM.   "
186570|NCT00279331|"     The purpose of this observational study is to estimate the number of new HIV infections and     the number and variability of antiretroviral-resistant HIV strains among men who have sex     with men (MSM). Participants will be recruited from four sites in Peru and one site in     Ecuador.   "
186571|NCT00279344|"     Primary objectives:        -  To determine non-inferiority of FITpatch with regard to efficacy compared to standard          opioid treatment        -  To assess the safety of FITpatch compared to standard opioid treatment      Secondary objectives:        -  To assess the intake of oral morphine as rescue analgesic to FITpatch compared to          standard opioid treatment        -  To assess Quality of life reported with FITpatch compared to standard opioid treatment   "
186572|NCT00279357|"     Does a new colonoscopic viewing technique called narrow band imaging (NBI) help doctors     detect more patients with at least one pre-cancerous polyp (adenoma) than conventional     colonoscopy using white light alone?      May 2007 protocol minor amendment: additional viewing by endoscopists outside St Mark's ro     allow assessment of inter- and intra-observer variability.   "
186578|NCT00279448|"     To compare recurrence free survival between two treatment groups (5 years with exemestane vs     2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5     years)      This Pfizer sponsored trial is part of an international collaboration of investigators     conducting 7 similar yet independent studies in 9 countries. This study is designed to be     part of the larger TEAM trial where the data from these 7 studies will be combined. A     pre-specified analysis of the pooled data will be conducted. Link to TEAM Trial     [971-ONC-0028-081/A5991026] Study Results:     http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081&rank=1   "
186579|NCT00279461|"     Recent studies have demonstrated that subjects with low blood levels of vitamin D are at a     higher risk of developing autoimmune diseases such as Rheumatoid Arthritis (RA). We are     pursuing these studies to test the hypothesis that restoration of vitamin D levels     ameliorates the manifestations of RA. We will test this hypothesis by inviting patients with     RA to participate in a trial that examines the effects of oral vitamin D administration on     the clinical expression of this disease. For this purpose, the participants of this trial     will be asked to take an oral dose of 2,000 units of vitamin D daily for 6 months. We will     examine the participant's joints, assess disease activity measures, and determine his/her     blood levels of vitamin D before starting this treatment and periodically thereafter.   "
186580|NCT00279474|"     The aim of the study is to evaluate the effect of cognitive behavior group intervention with     cancer patients and their family members. Around 80 cancer patients and their family members     will participate in group intervention and will be compared with 80 controls.   "
186581|NCT00279487|"     The purpose of this study is to determine whether gabapentin, as a one time administration     prior to a total knee replacement procedure, has opioid sparing effects and a reduction in     pain scores.   "
186582|NCT00279500|"     The objective of this study is to evaluate the safety and efficacy of the retinal stimulation     system by evaluating the data after chronic implantation.   "
186651|NCT00280670|"     This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT)     program for treating anxiety symptoms, social problems, and adaptive behavior deficits in     children with autism spectrum disorders.   "
186583|NCT00279513|"     Hallux valgus is a common deformity of the big toe, defined as medial deflection of the first     metatarsal bone along with lateral deflection of the first toe. Surgery has been shown to be     beneficial when compared to orthoses or no treatment. While generally effective, surgery     entails significant post-operative pain, inflammation and edema, and several weeks of limited     mobility. This will be a double-blind, randomized, placebo-controlled study comparing the     homeopathic drug Traumeel S with placebo in pain reduction after surgical Hallux valgus     correction.      80 patients, over the age of 18 years, undergoing surgical correction of unilateral hallux     valgus will be enrolled in the trial. The patients will be randomized to two groups, one     receiving oral Traumeel S and the other oral placebo tablets. Patients will take active or     placebo medication for 13 days or until they have a NRS score of 3 or less for 2 consecutive     days. Pain will be reported daily by the patient on the patient diary, using an 11-point     numerical rating score (NRS-11) during 13 days post-operatively. They will also be asked to     report daily consumption of primary and rescue analgesics for 13 days post-operatively.     Patients will be contacted daily by the research assistant to encourage compliance and to     record their daily NRS and analgesic consumption in the CRF. Patients will be evaluated by     physicians at six and 13 days postoperatively for redness and compliance.   "
186584|NCT00279526|"     The increase in life expectancy in the 21st century has resulted in a major growth in the     prevalence of age-related diseases and conditions. Depression has been found to be the most     prevalent among the various mental disorders in later life. It was emphasized that depression     in the elderly is a persistent or recurrent disorder resulting from psychosocial stress or     physiologic effects of disease and can lead to disability, cognitive impairments, intensified     symptoms of other medical conditions and increased utilization of health care services. Due     to the rapidly aging population, depression is a serious public health concern that has a     great impact on quality of life and may lay a considerable burden on the health care systems.     However depression among the elderly may prove to be hard to diagnose since in aged persons     depressive symptoms are often masked by somatic complaints or by cognitive impairments.     Consequently depression is often under diagnosed and the patients continue to visit     constantly the nurse or the physician without getting an adequate answer to their problem.     For that reason over utilization of health care services may be an indicator to the presence     of undiagnosed depression. The purpose of this study is to examine the relationships between     socio-demographic variables, high primary care utilization and depressive symptomatology     among aged patients.   "
186585|NCT00279539|"     The purpose of this study is to evaluate the safety and bioactivity of intramyocardial gene     transfer using VEGF (vascular endothelial growth factor) in patients with ischemic heart     failure. The research treatment of this CHF study will involve the use of an intramuscular     injection with a catheter inserted in through the groin to transfer a type of DNA (phVEGF165     gene) to the wall of the heart. Genes (which are part of the DNA molecules) carry     instructions to allow the cells to produce specific proteins. Gene transfer or treatment with     DNA (a necessary part of all cells) is being studied for the treatment of patients with heart     failure. This research therapy, which is experimental and not proven, is designed to try to     grow new blood vessels to improve blood flow to areas of the heart that are not receiving     enough blood.      DNA is present in all cells and provides the instructions for making proteins. After     delivering a piece of DNA containing the vascular endothelial growth factor 1 (VEGF-1) gene     (the product being studied) into cells, the cells may produce a specific protein called     vascular endothelial growth factor 1 (VEGF-1). Animal studies have indicated that the VEGF-1     protein may cause new blood vessels to grow. The Vascular Endothelial Growth Factor Gene (ph     VEGF 165) is found on the VEGF DNA. Experiments performed in animals show that once in the     heart wall, the DNA directs the cells of the heart muscle to make the VEGF protein. VEGF 165     is a protein that has been shown to stimulate cells (known as endothelial cells), which form     the inner lining of blood vessels. This protein causes cells to divide and grow, thereby     forming new blood vessels. It is anticipated that this new blood supply may help the heart     pump the blood more effectively and relieve some heart failure symptoms. We do not yet have     enough information to know what will happen in humans, that is why we are doing this     research.      After gene transfer we will begin a process to help move some of the stem cells from the bone     marrow into the blood circulation. Subjects will be given the drug called G-CSF (a drug used     to move cells from the bone marrow into the blood stream). Stem cells are young cells     produced by bone marrow (the spongy cavity in the center of large bones) that can develop     into blood cells or other types of cells. This medication triggers the movement of stem cells     out of the bone marrow and into the blood stream. Before being released into the blood     stream, stem cells receive signals that direct them to become specific types of cells such as     CD34+ cells (endothelial progenitor cells). CD34+ cells that move to or are in the area of     damaged heart tissue may promote growth of new blood vessels that supply blood and nutrients     and thereby improve the chance of survival of heart tissue, improve heart function, and     possibly have a long-term benefit.      We will be recruiting 12 subjects for this study. There will be no randomization and no     placebo group. Once eligibility in the research study has been determined all subjects will     be treated with the VEGF and G-CSF.   "
186839|NCT00291135|"     A pilot study to assess the effects of six months of letrozole on breast tissue risk markers     in postmenopausal women on hormone replacement therapy at high risk of developing breast     cancer.   "
186586|NCT00279552|"     Vitamin B12 is an essential nutrient for normal DNA-synthesis and must be supplied by animal     products. Vitamin B12 deficiency may cause anemia and irreverible neurological damage.     Laboratory tests are used for diagnosis of vitamin B12 deficiency, and following the     diagnosis, the cause of the vitamin B12 deficiency has to be clarified. For years a test     called Shilling’s test has been used for evaluation of the vitamin B12 absorption. However,     the Schilling’s test is no longer easy accessible because of increasing difficulties to     obtain the radioactively labeled vitamin B12 requested, and native human intrinsic factor for     Schilling’s test II (absorption of vitamin B12 attached to intrinsic factor) is no longer     available in most countries. Recently, human intrinsic factor unsaturated with vitamin B12     has been expressed in the plant Arabidopsis thaliana. The purpose of this study was to     examine whether recombinant human intrinsic factor is able to promote the uptake of vitamin     B12 in patients with evident vitamin B12 deficiency.   "
186587|NCT00279565|"     This randomized, single-center, controlled study is designed to evaluate the safety,     tolerability, and efficacy of treatment with Peg-Intron with Rebetol in methadone or     buprenorphine maintenance patients with hepatitis C.   "
186588|NCT00279578|"     In the present study we are examining the clot formation and clot stability in patients with     severe haemophilia A after they receive recombinat factor VIII and after addition of     tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability.     The perpective of the study is to document whether it is relevant to use traneksamic acid in     surgery in patients with severe haemophilia A.   "
186589|NCT00279591|"     A randomized controlled trial compared the clinical outcomes of transported pediatric     patients monitored with an oscillometric blood pressure device versus those monitored with a     near-continuous, noninvasive blood pressure.   "
186681|NCT00281060|"     Minimal invasive treatment (called endovascular) of the arteries of the lower limb remains     problematic, because recurrent disease (restenosis) frequently leads to recurrent symptoms.     As yet, balloon angioplasty remains the recommended strategy to revascularize the superficial     femoral artery (artery of the thigh). We investigated whether the use of a vascular     endoprosthesis (stent) improves patients´ outcome.      Study hypothesis: Primary stenting with self expanding nitinol stents may improve patency     after endovascular treatment of superficial femoral artery obstructions compared to balloon     angioplasty with optional stenting.   "
186590|NCT00279604|"     INCA (Intervention and Neuropsychology of Cannabis Abuse) is a study combining two research     goals. One is to study efficacy of a short intervention the ‘Problem Profile Intervention’,     which utilizes individual feedback from a ‘substance problem check-up’. Subjects will     randomly receive the ‘Problem Profile Intervention’ or the WHO Brief Intervention, a brief     intervention, which has been shown to be efficacious. Currently efficiency studies are under     way. The WHO Brief Intervention has been translated into German by our group. In contrast to     most other cannabis intervention studies the current study is focussed on cannabis abusers     not so much cannabis-dependent subjects. A total of 160 subjects are to be recruited. Half of     them will randomly receive either the Problem Profile Intervention or the WHO Brief     Intervention (active control). A total of 25% of subjects from each group will be placed on a     3 months waiting list before receiving the intervention (inactive control). Intervention     outcome will be assessed three months, six month and 12 months after the intervention. We     hypothesize cannabis use to be reduced by 25% by the 'Problem Profile Intervention'. The     second aim of the study is to study mechanism of substance abuse. Initial results from own     studies and data from other groups point to executive cognitive functions as a subtle but     important factor that can be compromised in cannabis users (Verdejo-Garcia et al., 2004;     Garavan and Stout, 2005). Using an fMRI-study, we intend to examine a subgroup of our     subjects on a specific aspect of executive functioning that has recently received major     interest in drug research: Decision-making capability, or risk-taking behaviour, respectively     (e.g. Ernst and Paulus, 2005).   "
186591|NCT00279617|"     The main purpose of this research study is to determine whether the drug Levetiracetam     (Keppra™) is effective in the prevention of panic attacks. The drug Levetiracetam (Keppra™)     has been approved for the treatment of seizures by the U.S. Federal Food and Drug     Administration (FDA) and is available by prescription. Levetiracetam has not been approved by     the FDA for the treatment of panic disorder.   "
186592|NCT00279630|"     Posterior tibial tendon dysfunction (PTTD) is the most common cause of painful and     debilitating acquired flatfoot deformity in adults. The dysfunction is often progressive and     may result in attenuation of the PTT and eventually collapse of the plantar arch or even     rupture of the tendon. Current therapeutic management of PTTD is multipronged and includes     management with foot orthoses, stretching, and strengthening exercises. Evidence drawn from     research related to the management of painful chronic Achilles tendinosis suggests that     eccentric strengthening of the posterior tibialis may lead to superior results compared to     concentric. The purpose of this research is to determine the effectiveness of treatment     interventions used in the management of PTTD.   "
186593|NCT00279643|"     The purpose of this study is to learn more about how hair removal with lasers achieves, what     appears to be, permanent hair reduction. Laser hair removal has become one of the most     popular and commonly performed procedures in cosmetic dermatology. However, relatively little     is known about how the permanent reduction in the treated areas occurs. Recently, it has been     discovered that certain cells in the hair follicle must be destroyed in order to achieve     permanent hair reduction. A marker of these types of cells known as keratin 15 has been     identified. By measuring the amount of keratin 15 before and after laser therapy, we hope to     gain a better understanding of how lasers cause hair reduction on a biochemical level.   "
186594|NCT00279656|"     The purpose of this study is to evaluate the impact of a collaborative approach (geriatric     care involving the collaboration with a clinical pharmacist) to optimize the prescription of     medicines for elderly inpatients.   "
186595|NCT00279669|"     Premature infants stand a risk of danger to the layer of the eye that creates sight that, if     untreated, can cause severe vision problems, leading to blindness in some cases. This     research study will use ultrasound to examine the eye for retinal changes of prematurity.   "
186596|NCT00279682|"     The purpose of this study was to determine the effect of a primary care intervention on     reducing suicidal ideation and depression in older patients.   "
186598|NCT00279708|"     This study will determine if atorvastatin (Lipitor) can help patients with pulmonary (lung)     sarcoidosis and replace or reduce the need for patients to take steroids, such as prednisone.     Sarcoidosis is an inflammatory disease that can affect nearly any part of the body. Pulmonary     sarcoidosis may resolve on its own or it may progress to irreversible lung damage,     disability, and death. Many sarcoidosis patients are treated with prednisone, but the drug is     not effective in all patients, and it can cause serious side effects, such as high blood     pressure, sugar diabetes, eye cataracts, and bone thinning.      Patients with stage II or III pulmonary sarcoidosis between 18 and 70 years of age who     require prednisone may be eligible for this study. Candidates are screened with the tests and     procedures described below.      Participants are randomly assigned to one of two treatment groups: one group takes     atorvastatin; the other takes a placebo (a look-alike pill that has no active ingredient to     fight sarcoidosis). Both groups take the pills by mouth once a day for 12 months. When     treatment begins, participants begin to have their prednisone dosage tapered (reduced). The     tapering is done over 8 weeks until the dose is reduced by 90 percent. Patients are evaluated     periodically to determine if the two groups differ in how long they can remain on the reduced     dose of prednisone without having their symptoms recur, requiring an increase in the     prednisone dose. A full battery of tests is done at the initial screening visit and at the     26- and 52-week follow-up visits, requiring hospitalization for 3-5 days. Additional interim     outpatient assessments are done at 6, 12, 18 and 36 weeks.      The full battery of tests at the initial screening and the 26- and 52-week visits includes     the following:        -  Medical history, physical examination, blood and urine tests, assessment of disease          severity and activity.        -  Questionnaires.        -  Chest x-ray (CXR) and computed tomography (CT) scan.        -  Abdominal ultrasound.        -  Six-minute walk test (6MWT)        -  Exercise testing and blood gases        -  Pulmonary function tests (PFT)        -  Maximum incremental ventilatory performance test (MIVP)        -  Exhaled nitric oxide and carbon monoxide (Exhaled NO and CO)        -  Bronchoscopy and lavage      Interim testing at 6, 12, 18 and 36 weeks includes PFT, MIVP, Exhaled NO and CO, CXR,     questionnaire, blood tests, and 6MWT.      Six months after completing the study, participants fill out a questionnaire.   "
186599|NCT00279721|"     Resected well-differentiated thyroid neoplasms with at least one high risk feature will     receive adjuvant radiation using IMRT with SIB. The acute toxicity and locoregional control     rate at 2 years will be recorded.   "
186600|NCT00279734|"     Study to assess the ability of healthy subjects to build anitbodies to tetanus and     pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is     being developed for the treatment of Rheumatoid Arthritis and which can affect the immune     system.   "
186601|NCT00279747|"     A one year double-blind trial to investigate the efficacy and safety of meloxicam oral     suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral     suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.   "
186604|NCT00279786|"     Beta(2)-adrenergic receptor (BAR) agonists are the most important group of drugs used in the     treatment of asthma. In children unresponsive to inhaled BAR agonist therapy, higher dose     systemic BAR agonist therapy is frequently the next step in treatment. Despite the widespread     use of intravenous BAR agonist therapy for pediatric status asthmaticus, there is controversy     regarding the efficacy of this therapy. A number of studies have established that genetic     variations of the BAR have important effects in modulating responses to BAR agonist therapy     for asthma. In particular, changes in amino acid position 16 of the BAR gene are thought to     be the most functionally important. Patients encoded for two glycine amino acids, rather than     arginine, at this position appear to have more severe asthma and to respond differently to     acute BAR agonist therapy.      Our hypothesis is that genotypic differences may contribute to poor response to acute BAR     agonist treatment. We propose to conduct a prospective observational study to determine the     influence of a patient's BAR genotype on the response to acute BAR agonist therapy.      Our specific hypothesis is that children with genetic polymorphisms of the gene encoding the     BAR will have a decreased response to acute high-dose continuous BAR therapy (both inhaled     and intravenous) compared to other children.      Our primary outcome is ICU length of stay. Secondary outcomes are        1. to assess the rate of improvement in clinical asthma score based on genotype, and        2. to attempt to correlate asthma phenotype with genotype by comparing demographic data and          hospital course.   "
186605|NCT00279799|"     AFIYA aims to reduce both the risk of Sexually Transmitted Infections (STIs) and HIV in young     African American females through a culturally and gender appropriate intervention (group     sessions) coupled with an individualized HIV Telephone Maintenance Intervention.   "
186606|NCT00279812|"     The aim of the study is to investigate the relationship between dose and form of selenium on     immune function, and to identify functional markers of selenium status.   "
186607|NCT00279825|"     The objective of this study is to compare the pharmacokinetics and pharmacodynamics of     IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa     controlled-release tablets in subjects with idiopathic Parkinson's disease.   "
186608|NCT00279838|"     The purpose of this study is to determine whether intraoperative computer-assisted navigation     improves prosthetic implant positioning as compared to conventional intraoperatve     instrumentation in Total Knee Arthroplasty (TKA).   "
186609|NCT00279851|"     The purpose of this study is to determine if there is a significant percentage of children     with the diagnosis of idiopathic seizures who have undiagnosed or unrecognized hypoglycemia     (low blood sugar).   "
186610|NCT00279864|"     Prosthetic joint infection is a devastating complication of total joint arthroplasty     ultimately leading to the failure of the total joint arthroplasty function and possibly     death. Optimal treatment requires the resection of the infected total joint arthroplasty     followed by prolonged parenteral antimicrobial therapy. This procedure is followed by     reimplantation of a new total joint arthroplasty at a later date. Surgical debridement and     retention of the infected total joint arthroplasty offers a more conservative surgical     approach and has been proven to be cost-effective in selected groups of patients. Traditional     medical therapy for staphylococcal infection would require an initial parenteral     antimicrobial followed by chronic oral non-rifampin containing antimicrobial suppression     regimen for the life of the total joint arthroplasty. With this strategy the success rate is     close to 30%. Recently, several prospective studies of patients with THA, TKA and fracture     fixation device infections conducted in Europe showed that the success rate with a 3-6 month     course of a quinolone-rifampin combination is effective in 70% to 100% of cases. The proposed     study will be a prospective open label observational cohort that will evaluate the outcome of     Patients with S. aureus PJI treated with a medical regimen that includes oral levofloxacin-     rifampin and debridement and retention of components. This medical regimen was approved for     use by the Orthopedic Infectious Diseases focus group, Mayo Clinic, Rochester. 15 patients     will be enrolled over a one-year period and followed up to minimum of 1 additional year. The     outcome of this group will be compared to a historical group that is treated with traditional     therapy.   "
186613|NCT00279903|"     Patients with painful knee osteoarthritis will be randomly allocated to one of three groups.     Each group will receive a knee injection of: 1) cortisone, 2) low dose Botox, or 3) high dose     Botox. Patients will then be followed for 6 months to see if they have significant pain     relief or improvement in their activity level after the injection.   "
186614|NCT00279916|"     We hypothesize that intranasal steroid application will have a beneficial therapeutic effect     in adults with regard to resolution of serous otitis media and/or negative middle ear     pressure, as compared to placebo. We further hypothesize that the rate of spontaneous     short-term resolution of otitis media wit effusion in adults treated with placebo will be     relatively low (minority of patients).   "
186634|NCT00280449|"     This study will examine the effects of having a case manager help PHAs access and use health,     social services and practical resources that are helpful to their needs as compared to the     usual more PHA self-managed approach of deciding and using services as they see necessary.     New and existing users of HIV/AIDS services in Wellington-Dufferin, Waterloo and Grey-Bruce     Regions who consent to this study will be randomized to receive their usual self-directed     supportive, educational, medical and medical care services when they seek assistance     according to their needs or these usual services augmented by case management services. They     will be measured before randomization and at 3, 6 and 12 months following service use for     their satisfaction with HIV/AIDS services, compliance with HIV/AIDS medication, improvement     in quality of life, psychological distress, risk behaviours and expenditures for the use of a     range of publicly funded services.   "
186721|NCT00281593|"     To identify dose combinations of telmisartan and ramipril that are more effective in reducing     diastolic blood pressure than each of the respective monotherapies in patients with Stage I     or II hypertension.   "
186615|NCT00279929|"     The role of dehydroepiandosterone (DHEA) and its sulphated ester (DHEAS) [together known as     DHEA(S)] in humans remains to be fully elucidated. They are the most abundant circulating     steroid hormones in humans with the principle source of production being the adrenal glands.     In adrenalectomised or hypoadrenal subjects it is not standard clinical practice to replace     this hormone. Whilst this lack of DHEA(S) is clearly not life threatening, the published     literature on the psychological effects of replacement in this population has shown some     benefit in quality of life but data concerning the metabolic effects is conflicting and     incomplete. We wish to carry out a study to measure the effect of DHEA(S) replacement in a     group of adrenalectomised / hypoadrenal subjects and measure the outcome of a number of     psychological and metabolic parameters both prior to and after twelve weeks of 50 mg/day     DHEA(S) in a double blind randomised cross over design.      Mood, quality of life and sexual well being will be assessed using validated questionnaires.     In addition, we will utilise the GCRC facility to measure body composition using total body     water and DEXA. We will measure insulin sensitivity, exercise performance, muscle     fatigability and VO2 max. Pre- and post- intervention muscle biopsies will assess DHEA(S)     effects on myosin heavy chain isoform expression; skeletal muscle mitochondrial ATP     production and be used to assess muscle enzyme levels.   "
186616|NCT00280215|"     This study will test the effectiveness of two medications: ACEI (angiotensin converting     enzyme inhibitor)and ARB (angiotensin receptor blocker) in reducing the renal injury induced     by hyperoxaluria in patients with Primary Hyperoxaluria.      Hypothesis: Calcium oxalate crystal deposition in the kidney causes inflammation and     resulting injury to kidney tissue. Angiotensin blockade will improve these changes, thus     slowing the progression of renal insufficiency in patients with Primary Hyperoxaluria.   "
186617|NCT00280228|"     This study will compare two programs to see if they are helpful in preventing the use of     substances in adolescents with attention deficit-hyperactivity disorder (ADHD), oppositional     defiant disorder (ODD), or conduct disorder (CD). One of the programs involves working with     adolescents and their parent(s) in their home. The other program involves working with     adolescents and their parent(s) in an office setting.   "
186618|NCT00280241|"     This research study will look at the effects (good or bad) of administering cyclophosphamide,     fludarabine, and rituximab. Clinical studies with combination therapy have shown higher     response rates than using single drugs, and this study will evaluate the side effects and     effectiveness of this combination.   "
186619|NCT00280254|"     The purpose of this study was to compare two strategies in the treatment of outpatients with     heart failure. We hypothesized that an individualized treatment strategy based on the     availability of hemodynamic data from non-invasive testing would be feasible and     significantly reduce morbidity compared to the conventional clinically oriented treatment of     heart failure outpatients.   "
186620|NCT00280267|"     The purpose of this study is to determine the feasibility of testosterone replacement therapy     in frail elderly female hip fracture patients who have testosterone deficiency, and to obtain     preliminary information about the effects of testosterone therapy on muscle strength and     size, bone density, mobility, daily functioning, and quality of life.   "
186621|NCT00280280|"     The purposes of this pilot study are to evaluate the safety and efficacy of Botox® compared     to the safety and efficacy of oral baclofen in reducing muscle tone-related disability     resulting from neurological damage or a stable neurological disorder and to evaluate     drug-therapy tolerance.   "
186622|NCT00280293|"     The purpose of this study is to determine if lamotrigine add-on therapy is associated with     decreased cocaine craving and improvement in depressive symptom severity than placebo in a     group of outpatients with bipolar disorder and cocaine dependence. Additionally, this study     is examining whether lamotrigine add-on therapy is associated with decreased cocaine use and     the improvement of manic symptom severity than placebo in a group of outpatients with bipolar     disorder and cocaine dependence.   "
186623|NCT00280306|"     White matter fiber tracking may provide a novel tool to assess the integrity of injured motor     tracts in the cervical spine. It provides information about fiber directions which is not     given by conventional MRI. White matter fiber tracking in the brain is used at several     institutions, including our own medical college, for presurgical planning of tumor excision.     We believe that the technical and clinical experience gained for the brain can be applied to     fiber tracking in the cervical spine as well.   "
186624|NCT00280319|"     That interpersonal psychotherapy and creative play therapies can reduce symptoms of     depression among adolescents with depressive-type illness in northern Uganda.   "
186625|NCT00280332|"     -  To determine the prevalence of colonic neoplasm in patients who had previously undergone          screening colonoscopy        -  To determine the optimal time interval for re-screening in average risk individuals        -  To determine potential baseline characteristics that predicts adenoma recurrence   "
186626|NCT00280345|"     Based on these recent observations and findings in this new animal model of pigmentary     glaucoma in the DBA/2J mouse, we propose that immune system abnormalities in the anterior     chamber may play a possible role in the development of pigmentary glaucoma and possibly     primary open-angle glaucoma (POAG) in humans.   "
186627|NCT00280358|"     The purpose of the study is to obtain initial pharmacokinetic data in healthy patients after     dosing a combination of the study medications.   "
186628|NCT00280371|"     The purpose of this study is to determine the safety and efficacy of the investigational drug     in comparison with a placebo.   "
186629|NCT00280384|"     To evaluate inter-ethnic similarity in pharmacodynamics between Japanese and Caucasian     healthy adult male subjects by comparing electrophysiological reactions after administering     E2014 to extensor digitorum brevis muscle (EDB).   "
186630|NCT00280397|"     The purpose of this study is to determine the maximum tolerable dose (MTD) and the related     effects of E7080 administered to patients with solid tumors that are resistant to approved     existing anti-tumor therapies, or for which no appropriate treatment is available.   "
186631|NCT00280410|"     This is a multicenter, randomized, open-label study to investigate the superiority of the     contrast enhancement effect of E7337 on tumor-like lesions in the Dynamic CT of the liver.   "
186632|NCT00280423|"     This study is designed to find the optimal (best) doses of GW679769 that could be given daily     to promote sleep onset and maintain sleep during the night without significant next-day     thinking impairment and drowsiness in subjects with primary insomnia.   "
186635|NCT00280462|"     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in     perfusion pressure. For a long time it had been assumed that the choroid is a strictly     passive vascular bed, which shows no autoregulation. However, recently several groups have     identified some autoregulatory capacity of the human choroid. In the brain and the retina the     mechanism behind autoregulation is most likely linked to changes in transmural pressure. In     this model arterioles change their vascular tone depending on the pressure inside the vessel     and outside the vessel. In the choroid, several observations argue against a direct     involvement of arterioles. In a previous project we were able to identify that the nitric     oxide (NO) - system as well as the endothelin system are involved in choroidal blood flow     regulation during isometric exercise.      In the present study autoregulation of the choroid during isometric exercise will be     investigated and the pressure/flow relationships will be observed in the absence or presence     of a calcium antagonist - nifedipine.   "
186636|NCT00280475|"     The aim of this study is to evaluate non-inferiority of salvage stereotactic radiosurgery     (SRS) in the patients who received surgical resection for brain metastases in comparison with     postoperative whole brain radiation therapy (WBRT).   "
186637|NCT00280488|"     The primary goal of this study is to test the efficacy of a brief intervention that includes     the patient and a significant other, relative to an intervention including the patient only,     for reducing alcohol use and alcohol-related problems among trauma patients.   "
186638|NCT00280501|"     There is evidence from a variety of animal studies that choroidal blood flow is under neural     control. By contrast, only little information is available from human studies. Recent results     indicate that a light/dark transition is associated with a reduction in choroidal blood flow     due to an unknown mechanism. We have shown that during unilateral dark/light transitions both     eyes react with choroidal vasoconstriction strongly indicating a neural mechanism responsible     for the blood flow changes.      Dopamine has been discussed as a chemical messenger for light adaptation. However,     dopaminergic effects in the eye are not restricted to synaptic sites of release, but dopamine     also diffuses to the outer retinal layers and pigment epithelium. Accordingly, dopaminergic     effects also include a modulatory role on retinal vessel diameter and animal studies provide     evidence for vasodilatory effects in the choroid. There is evidence that during darkness     retinal and choroidal dopamine levels decrease. Accordingly, dopamine could provide a     modulatory input to the light/dark transition induced changes of choroidal circulation. The     aim of the present study is to test this hypothesis.   "
186639|NCT00280514|"     Penetration of cefpirome and moxifloaxacin into abscess fluid of humans will be tested.     Patients with an abscess scheduled for drainage will receive study drugs (single or multiple     dose), pus samples and plasma samples will be collected and analyzed by High pressure liquid     chromatography (HPLC). Pharmacokinetics of the study drugs in pus and plasma will be     determined using a pharmacokinetic model.   "
186640|NCT00280527|"     It is known that a vast majority of patients seeking a bariatric surgery weight reduction     procedure have non-alcoholic fatty liver disease (NAFLD), while a smaller subset of patients     within this group have a more serious liver problem known as nonalcoholic steatohepatitis     (NASH). NASH is a serious liver disease that can lead to cirrhosis, liver failure and     ultimately liver transplantation. The purpose of this study is to explore the effects of     bariatric surgery on the progression of NASH. The investigators also hope to gain insight     into which genes may be responsible for the development of NAFLD and NASH. The knowledge     gained from this study will advance the field of fatty liver disease and help design rational     treatments to prevent disease progression.   "
186641|NCT00280540|"     This is a double-blind study to evaluate the reduction in systolic blood pressure using a     therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg     compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).   "
186642|NCT00280553|"     The incisions used in abdominal surgery can be quite painful, requiring strong pain     medications. A new pain pump that trickles small amounts of local freezing into the incision     has been developed that helps numb the area so that the patient does not feel the pain for     two to five days after surgery.      The main research question is whether use of the pain pump will result in decreased hospital     length of stay. The research is important because if the pain pump is found to be effective,     it can substantially decrease the length of stay. Areas to be studied include hospital length     of stay, patient's comfort post-operatively, and post-operative complications.   "
186643|NCT00280566|"     The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue     to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or     mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the     regimen.   "
186644|NCT00280579|"     Aim: To determine the incidence of cyanide poisoning in fire victims.      20 consecutive patients will have the rest of their blood sample analyzed for cyanide.   "
186645|NCT00280592|"     Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these     patients are prone to have recurrent urinary tract infections. Cranberry has been     traditionally used for the treatment and prophylaxis of urinary tract infections but there is     no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this     disease. The aim of our study is to assess the efficacy and safety of cranberry in the     prophylaxis of urinary tract infections in patients with multiple sclerosis with a     prospective randomized, double-blind and placebo-controlled clinical trial.   "
186646|NCT00280605|"     The aim of the study is to collect, under daily practice conditions, clinical data on the     safety profile and the efficacy of a new formulation of alfuzosin administered once daily in     patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia     (BPH).   "
186647|NCT00280618|"     Primary:        -  To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated          with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin      Secondary:        -  Safety and tolerability of this regimen in these patients   "
186648|NCT00280631|"     The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in     patients with Myelodysplastic Syndrome (MDS)   "
187720|NCT00304889|"     The purpose of this study is to compare the outcome of treatment with nitazoxanide vs.     vancomycin for diarrheal disease due to Clostridium difficile in patients who have failed     previous treatment with metronidazole.   "
186652|NCT00280683|"     Nitric oxide is an important marker of airway inflammation in asthma. Nitric oxide may have a     protective role in patients with moderate to severe asthma. The investigators believe that a     natural amino acid, L-arginine, that augments nitric oxide levels can decrease asthma     exacerbations and improve the asthma care of moderate to severe asthma patients.      This study is a randomized, placebo controlled trial in which subjects will receive either 3     months of L-arginine supplementation or a placebo. The investigators will monitor subjects'     symptoms, the number of asthma exacerbations, and lung function. In addition, we will draw     blood, obtain induced sputum samples and measure exhaled breath nitric oxide levels at each     monthly visit.   "
186653|NCT00280696|"     A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory     trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in     patients from 16 to 65 years with epilepsy suffering from partial onset seizures.   "
186654|NCT00280709|"     The primary purpose is to compare patency of two different types of biliary metal stents,     i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine     frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and     cholangitis.   "
186655|NCT00280722|"     The purpose of this study is to investigate the feasibility of carrying out a full scale     randomised controlled trial to compare the effects of giving additional information versus no     additional information to patients prior to their first oncology appointment.      Hypothesis: Patients with some awareness of research provided prior to clinic appointment in     oncology and aware of the possibility of being invited to take part in a clinical trial are     more likely to agree to participate.   "
186656|NCT00280735|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells     that remain after surgery.      PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel     works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.   "
186657|NCT00280748|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Pemetrexed may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     radiation therapy together with pemetrexed may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving whole-brain radiation therapy     together with pemetrexed works in treating patients with brain metastases from non-small cell     lung cancer.   "
186658|NCT00280761|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors understand how patients respond to treatment.      PURPOSE: This clinical trial is studying biomarkers in patients with rectal cancer undergoing     chemotherapy and radiation therapy.   "
186659|NCT00280774|"     The purpose of this research is to determine if patients on corticosteroids who are given     memantine will show improvement in memory compared to those receiving placebo (an inactive     substance). This research also seeks to determine if such patients, when given memantine,     will experience improvement in manic/hypomanic symptoms (feelings of agitation,     overexcitement, or hyperactivity) and/or depressive symptoms. Subjects will be randomized to     a crossover trial of memantine and placebo for 8 weeks, followed by a 4 week washout and then     8 more weeks of the study medication. Memantine and placebo will start at 5 mg/day for one     week, increased to 5 mg twice a day in the second week. During the third week patients will     take 10 mg in the morning and 5 mg in the evening. At weeks 4-8, patients will take 10 mg     twice a day. One 8 week course of study medication will be memantine and the other 8 week     course of study medication will be placebo, both assigned in a random fashion.   "
186672|NCT00280943|"     Osteoporotic fractures of the hip are a major cause of admission to long-term care     facilities. Such fractures put patients at high risk for further fractures, pain and     disability. Current data show that many patients in long-term care facilities do not receive     FDA medications for their osteoporosis. This trial will test whether a multi-model     intervention (which provides feedback about provider use of osteoporosis medications,     information about osteoporosis, and currently approved osteoporosis medications)directed at     physicians, other health care providers, and nurses will improve the number of prescriptions     written for FDA approved medications for osteoporosis treatment.   "
186660|NCT00280787|"     Patients enrolled on this study will have been diagnosed with non-small cell lung cancer     which cannot be removed by an operation. The standard treatment for this disease is a     combination of chemotherapy and radiation therapy; however, the best way to combine these     treatments is not known. This study will examine if the combination of chemotherapy and     radiotherapy has an increased effect on slowing tumor growth with the addition of a drug     called ZD1839.      In this study, chemotherapy will be given initially (induction therapy) to try to control the     spread of the cancer. Then radiation and chemotherapy will be given together. Receiving     chemotherapy at the same time as radiation treatments can enhance the effect of the     radiation. In this study, patients will receive a drug called ZD1839. In laboratory tests on     cancer cells, ZD1839 has shown an additive effect when used in combination with radiation.     ZD1839 has also been shown to slow or stop growth in tumors.      The purpose of this study is to determine the side effects and effectiveness of using ZD1839     when used with radiation in this treatment regimen (induction chemotherapy followed by     combination chemotherapy, ZD1839, and radiation therapy).   "
186661|NCT00280800|"     Hypothesis: Computer controlled continuous positive airway pressure (autoCPAP) is equally     effective in improving obstructive sleep apnea syndrome symptoms, breathing disturbances,     objective vigilance, and it is cost-effective compared to conventional fixed continuous     positive airway pressure.   "
186662|NCT00280813|"     The purpose of the study is to evaluate a new treatment to help patients who have problems     because of their use of alcohol. The treatment is called Behavioral Treatment for Alcohol     Abuse in Schizophrenia (BTAAS).We are interested in determining whether BTAAS is more     effective in reducing use than a supportive control treatment.   "
186697|NCT00281281|"     1. Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug          toxicity.        2. There is limited data on the change of vancomycin pharmacokinetics in patients who need          extracorporeal membrane oxygenation (ECMO).        3. This control trial is to understand:             1. whether the pharmacokinetics of vancomycin is influenced by the use ECMO             2. design the most appropriate dose of vancomycin in adult patients using ECMO.   "
186698|NCT00281294|"     To evaluate the efficacy of fontolizumab in subjects with active rheumatoid arthritis as     determined by a 50% improvement of an American College of Rheumatology criteria (ACR50)     response at Week 14 (Stage A of study).   "
186911|NCT00292097|"     The purpose of this study is to evaluate the efficacy of early conversion tracheostomy from     endotracheal intubation (ET) to percutaneous, dilatational tracheostomy (PDT) in traumatic     brain-injured patients requiring prolonged mechanical ventilation.   "
186663|NCT00280826|"     This study examined the safety and potential efficacy of the monoclonal antibody efalizumab     (Raptiva) for treating sight-threatening uveitis (eye inflammation). Efalizumab controls the     activity of white blood cells called lymphocytes that cause inflammation. The drug is     currently approved in the United States to treat patients with moderate to severe psoriasis.      Participants 18 and older with sight-threatening intermediate or posterior uveitis of at     least 3 months duration, causing persistent macular edema in one or both eyes, were eligible     for this study. The uveitis required treatment with at least 20 milligrams per day of     prednisone, or the equivalent, or a combination of two or more anti-inflammatory treatments     such as prednisone, methotrexate, cyclophosphamide, cyclosporine, etc.      Participants underwent the following tests and procedures:        -  Medical history and physical examination.        -  Weekly efalizumab treatment.        -  Weekly eye examination, including measurement of vision and pressure in the eyes,          dilation of the eyes and examination of the front and back parts of the eye.        -  Weekly blood tests to measure the number and types of cells in the blood and to check          for signs of inflammation and treatment side effects. At some visits, blood samples were          collected to measure how much efalizumab remains in the blood and whether the body has          developed an immune response to the medicine.        -  Blood draw at enrollment and at 2 and 4 months for research tests to examine how          participants' immune response was operating.        -  Fluorescein angiography at enrollment and 1 and 3 months after enrollment, unless          additional tests are needed, for medical management. This test checked for abnormalities          of eye blood vessels. A yellow dye was injected into an arm vein and travels to the          blood vessels in the eyes. Pictures of the retina (the back portion of the eye) were          taken with a special camera that flashes a blue light into the eye. The pictures show          whether any dye has leaked from the vessels into the retina, indicating possible          abnormalities.        -  Monthly pregnancy test for women who could become pregnant.      Participants returned for treatment and clinic visits weekly for 16 weeks. After 16 weeks,     participants whose macular edema had decreased and whose vision may have improved were     offered to continue the injections.   "
186664|NCT00280839|"     The purpose of this research study is to determine if topiramate is safe and effective in the     treatment of smoking cessation   "
186665|NCT00280852|"     To describe the outcome of patients with anaplastic thyroid cancer treated with     hyperfractionated radiotherapy and concomitant chemotherapy   "
186666|NCT00280865|"     This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label     pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in     patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone     during the run-in period. The study comprises a 2-week enrollment period, 4 week placebo     single blind run in period followed by a 12-week double blind treatment period and a 3-week     follow-up period   "
186667|NCT00280878|"     This is a Phase II pilot study evaluating the safety of a risk-adjusted outpatient-based     approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim)     and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim) in combination with     Rituximab (R-VGF/R-F-GIV).   "
186668|NCT00280891|"     To describe the charactersitics of patients with advanced head and neck cancer treated with     palliative intent and determine outcome in terms of symptom control and toxicity   "
186669|NCT00280904|"     The purpose of this Registry is to compare shunt/catheter-related infection rates among     various shunt systems when used according to hospital standard of care to treat     hydrocephalus.   "
186670|NCT00280917|"     This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory     agent, will improve the clinical condition of patients with rheumatoid arthritis who still     have active joint inflammation despite taking methotrexate for at least 6 months.   "
186671|NCT00280930|"     The purpose of this study to see what happens to breast density in healthy postmenopausal     women after treatment with letrozole in one year, compared with treatment with placebo for     one year. Other goals of the study include determining if there is a connection between     estrogen level and breast density for women in the study and collecting information about the     quality of life of those taking part in the study.   "
186673|NCT00280956|"     The primary objective of this study is to evaluate the long-term tolerability and safety of     natalizumab when administered a dose of 300 mg intravenously (IV) to subjects with Crohn's     Disease who have previously participated in studies CD251, CD301, CD303, CD306, or CD307.   "
186674|NCT00280969|"     A selection study in treatment naive HIV patients to compare the virologic success rate of     once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and     abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen     will be hired to the comparative study to the current first line regimen (tenofovir plus     lamivudine plus efavirenz)   "
186675|NCT00280982|"     Exploiting the immunostimulatory capacities of dendritic cells holds great promise for cancer     immunotherapy. A mouse model for malignant mesothelioma allowed us to prove that autologous     dendritic cells presenting tumor antigens were very effective by (partly) inhibiting tumor     growth. This study will test the feasibility and safety of a clinical trial using autologous     DC as a therapeutic adjuvant for the treatment of malignant pleural mesothelioma.   "
186676|NCT00280995|"     The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 as     add-on therapy in subjects with Homozygous Familial Hypercholesterolemia   "
186677|NCT00281008|"     The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012     (mipomersen) as add-on therapy in subjects with Heterozygous Familial Hypercholesterolemia   "
186678|NCT00281021|"     The purpose of this study is to determine the potential benefit of adding Digoxin to     erlotinib (Tarceva) treatment for patients with non-small cell lung cancer.   "
186679|NCT00281034|"     1. To survey the health-related quality of life using the SF-36v2 score of patients with          chronic brain infarction in Japan        2. Chronic brain infarction in Japan is better than EU/USA   "
186680|NCT00281047|"     FP-10 is a food ingredient derived from milk casein. FP-10 can inhibit H. pylori to attach to     the gastric epithelium. FP-10 has been made clear to decrease the intragastric urease     activity (which is assumed to be produced by H. pylori) measured by the urea breath test.     FP-10 can also detach H. pylori from gastric epithelium. We have hypothesized that FP-10     increases the eradication rates by a triple therapy with a proton pump inhibitor,     amoxicillin, and clarithromycin.   "
186682|NCT00281073|"     This is a sequential phase 1 and phase 2 study to evaluate the efficacy of intracardiac     echocardiography to detect septal and left atrial pathology as compared to transesophageal     echocardiography (Phase 1) and its value in a management strategy for immediate cardioversion     during cardiac catheterization procedures in patients with atrial fibrillation as compared to     a conventional strategy delaying cardioversion till full anticoagulation is established for a     three weeks (Phase 2). Phase 1 will enroll 100 patients at 12 centers; these patients will be     undergoing clinically indicated TEE & cardiac catheterization procedures. After review of     Phase 1 results by an independent DSMB & the investigators that establish efficacy of ICE,     Phase 2 will be initiated. Phase 2 will enroll 300 patients in 15 centers; these patients     with atrial fibrillation will be undergoing clinically indicated cardiac catheterization     procedures and have a clinical indication for cardioversion. Patients will be randomized to     ICE guided cardioversion strategy or a conventional strategy employing three weeks of full     anticoagulation before cardioversion. ICE imaging will be used to identify a low risk group     for immediate cardioversion. A composite primary study endpoint that will include mortality     and major morbidity including stroke and bleeding complications will be used.      This study will examines two hypotheses in AF patients undergoing invasive cardiac     procedures:      Hypothesis 1: That ICE has comparable efficacy to TEE in visualization of left atrial     pathology or septal defects that can predispose patients to stroke. This will be evaluated     during the Phase I component of the study.      Hypothesis 2: That ICE can identify low risk patients in whom immediate cardioversion during     the procedure is safe and comparably effective to electrical cardioversion performed based on     a conventional strategy of a minimum of 3 weeks of preceding anticoagulation therapy. Low     risk patients are expected to have an acceptably low incidence rate of stroke, transient     ischemic attack (TIA), peripheral embolism, and major hemorrhagic events following electrical     cardioversion. This will be evaluated during the Phase II component of the study, after the     Phase I objective is achieved.   "
186683|NCT00281086|"     To address the problems of disparities in asthma care and morbidity by examining the     influence of environmental/genetic factors and stress on the development of asthma.   "
186684|NCT00281099|"     The purpose of the study is to compare two device settings (sets of instructions) used by the     ICD. The Implantable Cardiac Defibrillator (ICD) can be set to use one wire (top or bottom     of the heart) or two wires (top and bottom). The study will compare how much time either ICD     wire is used by the ICD and the status of congestive heart failure.   "
186685|NCT00281112|"     To evaluate asthma morbidity in low-income, African-American children and adults with asthma.   "
186686|NCT00281125|"     This is an open-label, two-arm, multicenter Phase IA/II dose-escalation study of PTK787 in     combination with Pemetrexed alone (Cohort 1) or Pemetrexed and Cisplatin (Cohort 2).      This study is designed to determine the maximum tolerated dose (MTD) and dose limiting     toxicity (DLT) of PTK787 when administered in combination with Pemetrexed or Pemetrexed and     Cisplatin, and to characterize the safety, tolerability, biologic activity, and PK profile of     PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas.   "
186687|NCT00281138|"     To reduce disparities in asthma among Latino children.   "
186688|NCT00281151|"     The purpose of this study is to determine the mechanisms underlying the disparities in asthma     and to improve asthma care in pregnant women, a targeted group at high risk for     asthma-specific maternal and perinatal complications.   "
186689|NCT00281177|"     The purpose of this study is to characterize the relationship of social stress, coping, and     self-regulatory health behaviors in the context of asthma disparities among African American     and low income populations.   "
186690|NCT00281190|"     The purpose of this study is to determine whether the alveolar macrophages (AMø) of patients     with chronic obstructive pulmonary disease (COPD ) show abnormal responsiveness to bacterial     and viral products, relative to smokers with normal pulmonary function. Participation in this     study will be offered to patients already scheduled to undergo a bronchoscopy for clinical     indications.   "
186691|NCT00281203|"     This study group forms the normal subject control group in an experiment designed to     determine whether the alveolar macrophages (AMø) of patients with chronic obstructive     pulmonary disease (COPD) show abnormal responsiveness to bacterial and viral products.     Specifically, the study will determine the dose-response characteristics of AMø for     production of interleukin (IL)-6, IL-18, and IL-23 (pro-inflammatory cytokines) on     stimulation by purified lipopolysaccharide, a synthetic lipopeptide (PAM3-Cys), or poly I:C.     These stimuli mimic the response to Gram-negative bacteria, Gram-positive bacteria, and RNA     viruses, respectively. Results of the AMø from these healthy volunteers will be compared with     AMø of COPD patients and smokers (or ex-smokers) with normal pulmonary function; those     samples are being obtained during clinically indicated bronchoscopies under a separate     consent form.   "
186709|NCT00281437|"     The current study was designed to investigate the influence of choice of exercise program on     exercise adherence. The two exercise programs included 1) traditional exercise at a fitness     centre or 2) lifestyle exercise-walking using a pedometer to track steps. Biological and     psychological indicators were examined to investigate the effect of choice in a sample of     sedentary adults.   "
186692|NCT00281216|"     The purpose of this study is to determine whether there is a statistical association between     the changes from baseline in the levels of two cytokines interleukin (IL)-17A and IL-6 in the     sputum of patients with chronic obstructive pulmonary disease (COPD) and the severity of     acute exacerbations of COPD (AE-COPD). These sputum cytokine levels are taken as measures of     the adaptive immune response (IL-17A) and the innate immune response (IL-6), respectively.     Sputum will be collected either spontaneously or will be obtained by induction; cytokine     levels will be measured by ELISA. The primary analysis, comparisons of sputum cytokine levels     between clinical states, will be done using random effects modeling.   "
186693|NCT00281229|"     The purpose of this study is to determine whether the lungs of individuals with chronic     obstructive pulmonary disease (COPD) contain resident memory T lymphocytes that can produce a     combination of cytokines that induce the symptoms of an acute exacerbation of COPD (AE-COPD).     Specifically, the study will determine cell-surface receptors of lung T cells in comparison     with blood T cells from the same subject, and will examine anti-CD3-activated blood or lung T     cells for interleukin (IL)-6 and interferon-gamma production in response to IL-18, and for     IL-17A production in response to recombinant IL-23.   "
186694|NCT00281242|"     The purpose of this study is to determine whether there is a statistical association between     changes in sputum serial levels of two cytokines, interleukin (IL)-17 and IL-6, during the     treatment course of a severe acute exacerbation of chronic obstructive pulmonary disease     (AE-COPD) and during the clinical course itself (i.e., rate of recovery or potential     complicated course). AE-COPD is defined as an episode requiring emergency room (ER)     evaluation.   "
186695|NCT00281255|"     This study will determine whether an acute infusion of intravenous allopurinol improves the     inotropic response to dobutamine in patients with idiopathic dilated cardiomyopathy (DCM) as     measured by cardiac magnetic resonance imaging (CMR).   "
186696|NCT00281268|"     To assess rapidly innovative treatment methods in patients with adult respiratory distress     syndrome as well as those at risk of developing ARDS.   "
186699|NCT00281307|"     Many beneficial effects of vitamin E have been described, but vitamin E supplementation by     mouth has not been effective in the treatment of nasal symptoms and allergic rhinitis. The     investigators will evaluate the effect of vitamin E directly applied to the lining of the     nose in individuals with moderate to severe rhinitis by symptom questionnaires.   "
186701|NCT00281333|"     Hemophilia patients tend to lower their physical activity level due to the fear of increasing     bleeding episodes. Although recent literature has shown that with routine muscle     strengthening and physical activity, the frequency and duration of bleeds was reduced. Our     study has built a routine of strength training exercises and karate training. The study is     built in two stages, each stage being three months. The participants fill out a bleeding     diary that includes information from the previous six months. It includes place of bleed,     duration, pain level, spontaneous or traumatic bleed, factor replacement and joint     limitation. Before the exercise, the participants are tested for muscle strength and     endurance. The bleeding diary will be filled out following the first three months and the     second phase as will the muscle strength and endurance. We are hoping to see a drastic     reduction of bleeding episodes occurring especially from spontaneous bleeds.   "
186702|NCT00281346|"     Non-invasive evaluation of patients with stable angina and unstable coronary syndromes with     transthoracic Doppler echocardiography to evaluate presence of significant coronary stenoses.     Blinded evaluation and comparison with coronary angiography: presence and location of     stenoses, and head to head comparison of clinical value and patient classification.   "
186703|NCT00281359|"     This study is looking at new ways to stretch knee contractures in children with cerebral     palsy using a specially designed splint.   "
186704|NCT00281372|"     Evaluation of sexual functioning of patients at the Sexual Medical Center, at Sheba Medical     Center in Israel. Sexual functioning shall be compared with their dental behavior.      Hypothesis: a positive association will be found.   "
186705|NCT00281385|"     This study is a comparison of the traditional prescription versus the lifestyle exercise     prescription in sedentary adults over 6 months. Biological and psychological parameters will     be assessed over the 6 month study. Biological indicators will be assessed pre and post     including body composition, muscular strength, endurance, and flexibility, aerobic fitness,     and blood tests. Psychological parameters will be assessed pre, mid, and post including     self-efficacy, motivation, need satisfaction, physical self-description, leisure-time     exercise, as well as all constructs from the thepry of planned behaviour.   "
186706|NCT00281398|"     Homelessness is a significant problem in Canada, and many homeless people will seek routine     care in the Emergency Department (ED) as a result of barriers to access. There is a paucity     of information in the literature concerning the attitudes of health care workers towards     homeless patients in the ED setting, although there is ample reason to believe that these     attitudes may be suboptimal. In the absence of formal teaching regarding issues of     homelessness, medical students have been shown to develop increasingly negative attitudes     towards this vulnerable population. It is therefore important to better delineate the     attitudes of ED physicians towards homeless persons and to develop an emergency medicine     curriculum that helps sensitize physicians to the needs of this already disadvantaged     population.   "
186707|NCT00281411|"     After endovascular abdominal aortic aneurysm repair, life-long follow-up is needed to monitor     the effectiveness of exclusion of the aneurysm sac from blood flow. For this reason, aneurysm     diameter and the presence of endoleaks is evaluated with CT angiography yearly after     Endovascular Aneurysm Repair (EVAR).      The aim of this study is to investigate the value of MRA examinations for the follow-up of     these patients. The advantages of MRA with respect to CTA are no use of ionizing radiation,     use of less nephrotoxic contrast agents.   "
186708|NCT00281424|"     The purpose of the project was to test the widely endorsed assumption that pedometers produce     or encourage more physical activity participation in the form of walking. The investigators     hypothesized that pedometers would not increase the amount of walking cardiac patients     participated in after their cardiac rehabilitation program compared to patients without     pedometers.   "
186710|NCT00281450|"     This study will explore the possible effect of a tailored educational intervention towards     general practitioners, in order to reduce inappropriate prescription patterns for elderly     patients > 70 years.   "
186711|NCT00281463|"     The purpose of this three phase study is to evaluate a Pushrim Activated Power Assist     Wheelchair (PAPAW). Phase I will examine whether the steady-state, metabolic energy     efficiency for propelling a manual wheelchair with and without the device will be     significantly different. In Phase II, wheelchair users will evaluate the PAPAW over     activities of daily living course to determine its usability and acceptability and to     identify areas for future development. Finally, in phase III, comparison of activities of     daily living in the community will be made between the subjects when using their personal     wheelchair and a PAPAW.   "
186712|NCT00281476|"     The purpose of the study is to evaluate the effect of high doses of Simvastatine on bone     metabolisme and biochemical markers of disease in Multiple Myeloma   "
186713|NCT00281489|"     The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and     Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of     patients remembering being awake during surgery. The BIS monitor may be able measure how     asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be     compared with using the concentration of anesthetic gas to guide anesthesia.   "
186714|NCT00281502|"     The study will be conducted in two phases. Phase A will evaluate the contribution of     bacterial overgrowth and colonic inertia to development of Hepatic Encephalopathy (HE)in 50     ambulatory subjects with HE and hepatitis C cirrhosis. This phase will include a Screening     and Evaluation Visit.      Phase B will evaluate the effect of rifaximin on bacterial outgrowth and severity of HE in 20     of the subjects enrolled in Phase A who have a somewhat greater degree of encephalopathy.      The purpose of this study is to evaluate the following:        1. the relationship between bacterial overgrowth and the presence and severity of HE in          patients with hepatitis C cirrhosis;        2. the effectiveness and tolerability of rifaximin relative to placebo in treatment of HE          associated with hepatitis C cirrhosis;        3. the relationship between bacterial overgrowth and the presence and severity of HE before          and after rifaximin treatment.   "
186722|NCT00281606|"     Guidelines have continued to list lopinavir/ritonavir as a preferred protease     inhibitor-containing regimen for HIV-infected individuals. There has recently been increasing     interest in once daily therapy. While lopinavir/ritonavir has recently been approved as a     once daily therapy it was associated with considerable diarrhea in those treated with soft     gel capsules. It is the hope that alternative formulations of lopinavir/ritonavir may provide     similar pharmacokinetics with improved tolerability. This includes the possibility of using     liquid or newly released tablets. This study will treat people tolerating their current     regimen with up to four weeks of each formulation with several assessments of     pharmacokinetics and tolerability for each.   "
186723|NCT00281619|"     The purpose of this study is to determine how fast children, who have had a recent kidney     transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their     prescribed dose. The results may lead to better dosing based on individual needs.   "
186724|NCT00281632|"     This study was designed to find out how effective and safe GW786034, is in the treatment of     epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to     standard treatment.   "
186725|NCT00281645|"     The primary objective of the study is to evaluate the safety and efficacy of bicifadine 400     mg BID for up to one year in patients with moderate to severe chronic low back pain.      The secondary objectives are to compare the long-term safety of bicifadine to standard of     care therapy, to evaluate the safety of bicifadine following discontinuation of dosing, and     to evaluate the safety and efficacy of lower doses of bicifadine in patients who do not     tolerate bicifadine 400 mg BID.   "
186726|NCT00281658|"     This is a Phase III study designed to evaluate the response (shrinkage or lack of growth) of     tumors of lapatinib plus paclitaxel compared to paclitaxel plus placebo as first line     metastatic treatment in women and men who have metastatic breast cancer. Patients will be     evaluated for safety and efficacy. Countries include China, Hong Kong, Thailand, Brazil and     Peru.   "
186727|NCT00281671|"     The purpose of this study is to determine the effects of nesiritide on urine output and     hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data     will also be obtained.   "
186729|NCT00281697|"     This phase III, multicenter, randomized, placebo-controlled, blinded trial is designed to     evaluate the efficacy and safety of bevacizumab when combined with standard chemotherapy     compared with chemotherapy alone in subjects with previously treated metastatic breast     cancer.   "
186730|NCT00281710|"     We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting     healthy humans   "
186731|NCT00281723|"     Recurrent Aphthous Stomatitis (RAS) of the oral mucosa is a common and painful condition.     Despite advances in therapeutic means there is still necessary to find a way to alleviate the     local pain and discomfort induced by the mucosal ulceration.      The hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in     the treatment of RAS.      Participants in the study will be examined for oral lesions, will be instructed how to apply     the oral-tablet, and will be interviewed during the follow-up period up to one week after the     application.   "
186732|NCT00281736|"     RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells.     The drug becomes active when it is exposed to light, and kills tumor cells. HPPH may be     effective in killing precancerous cells and tumor cells.      PURPOSE: This randomized phase II trial is studying how well photodynamic therapy with HPPH     works in treating patients with precancerous esophageal conditions or stage 0 or stage I     esophageal cancer.   "
186733|NCT00281749|"     A telephone call from a physician taking care of a patient in the hospital to a physician in     the long term care setting at the time of discharge can improve transitional care for elderly     patients. We believe direct communication between physicians can reduce re-hospitalizations,     medication errors, morbidity and mortality. No studies have been done that involve     physician-to-physician sign-outs after hospital discharge to the nursing home. In our study,     we would like to address the breakdown in the transfer of information to the nursing home     setting.   "
186734|NCT00281762|"     We wanted to test the hypothesis that prostaglandin inhibition reduces the down regulation of     u-AQP-2 induced by fasting   "
186757|NCT00282074|"     In this prospective open armed study we aim to see if bilateral hernia repair using a mesh     alters the spermatogram (sperm count) or testicular volume.   "
186735|NCT00281788|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, carboplatin, and paclitaxel,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when     given together with carboplatin, paclitaxel, and radiation therapy in treating patients with     esophageal cancer or gastroesophageal junction cancer.   "
186736|NCT00281801|"     RATIONALE: Questionnaires that measure quality-of-life may improve the health care team's     ability to plan supportive care for patients undergoing donor bone marrow transplantation.      PURPOSE: This clinical trial is studying quality of life in patients who are undergoing donor     bone marrow transplantation.   "
186737|NCT00281814|"     RATIONALE: Questionnaires that measure coping may improve the ability to plan supportive care     for patients undergoing donor bone marrow transplant.      PURPOSE: This clinical trial is studying coping in patients who are undergoing a donor bone     marrow transplant.   "
186738|NCT00281827|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor.     Giving carboplatin and gemcitabine together with thalidomide before surgery may make the     tumor smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together     with thalidomide works in treating patients who are undergoing surgery for stage II or stage     III non-small cell lung cancer.   "
186739|NCT00281840|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such     as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     tumor cells. Giving bevacizumab together with docetaxel and radiation therapy may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel     and radiation therapy works in treating patients with stage III or stage IV head and neck     cancer.   "
186740|NCT00281853|"     RATIONALE: Learning about the effects of chemotherapy and biological therapy on nerve     function may help doctors plan treatment and help patients live more comfortably.      PURPOSE: This clinical trial is studying peripheral neuropathy in patients who are receiving     chemotherapy or biological therapy for cancer.   "
186741|NCT00281866|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with     recurrent and/or metastatic head and neck cancer.   "
186742|NCT00281879|"     RATIONALE: A peripheral stem cell transplant or an umbilical cord blood transplant from a     donor may be able to replace blood-forming cells that were destroyed by chemotherapy or     radiation therapy. Giving an infusion of the donor's white blood cells (donor lymphocyte     infusion) after the transplant may help destroy any remaining cancer cells     (graft-versus-tumor effect). Sometimes the transplanted cells can make an immune response     against the body's normal cells. Methotrexate, cyclosporine, tacrolimus, or     methylprednisolone may stop this from happening.      PURPOSE: This clinical trial is studying how well a donor stem cell transplant or donor white     blood cell infusions work in treating patients with hematologic cancer.   "
186743|NCT00281892|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Darbepoetin alfa may cause the body to make more red blood cells. It is not yet known whether     fludarabine is more effective with or without darbepoetin alfa in treating chronic     lymphocytic leukemia.      PURPOSE: This phase III trial is studying fludarabine to see how well it works when given     together with or without darbepoetin alfa in treating older patients with chronic lymphocytic     leukemia.   "
186744|NCT00281905|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving radiation therapy after chemotherapy may kill any     remaining tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with or without radiation therapy works in treating children with brain tumors.   "
186745|NCT00281918|"     This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to     see how well they work compared to fludarabine and cyclophosphamide in treating patients with     B-cell chronic lymphocytic leukemia.   "
186746|NCT00281931|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in     different ways. Some find cancer cells and kill them or carry cancer-killing substances to     them. Others interfere with the ability of cancer cells to grow and spread. Giving     fludarabine and cyclophosphamide together with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide     together with rituximab works in treating patients with B-cell prolymphocytic leukemia.   "
186747|NCT00281944|"     This phase I trial is studying the side effects and best dose of oxaliplatin when given     together with leucovorin and fluorouracil in treating young patients with advanced solid     tumors. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.   "
186778|NCT00282347|"     This was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to     evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF)     compared with placebo in combination with MMF in subjects diagnosed with International     Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis.   "
186748|NCT00281957|"     This randomized phase II trial is studying how well giving sorafenib together with either     temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be     removed by surgery. Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may     also stop the growth of tumor by blocking blood flow to the tumor. It is not yet known     whether sorafenib is more effective when given together with temsirolimus or tipifarnib in     treating patients with malignant melanoma.   "
186749|NCT00281970|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after     surgery.      PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin     works in treating patients with stage I, stage II, or stage III non-small cell lung cancer     that has been completely removed by surgery.   "
186763|NCT00282152|"     Bilateral subthalamic nucleus deep brain stimulation (B-STN DBS) is one of the most effective     surgical treatments for PD patients suffering from levodopa-induced motor complications. The     relatively low incidence of permanent adverse effects and the potential for neuroprotection     and alteration of the natural course of PD suggest a highly favorable benefit-to-risk ratio     of this procedure. Since neuroprotection is best applied early in the disease course when     there are more surviving neurons, we believe that further investigation of this procedure is     warranted. The proposed pilot study will provide the necessary data to substantiate the     safety and tolerability of the procedure as well as provide data for the design of a     full-scale, multicenter trial to investigate the hypothesis that B-STN DBS is a safe and     effective treatment to slow the progression of PD.   "
186944|NCT00292539|"     This registry is a data collection on patients who are implanted for more than 6 months with     a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left     ventricular ejection fraction shall be documented.   "
186750|NCT00281983|"     RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem     cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either     kill them or deliver cancer-killing substances to them without harming normal cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving methotrexate, cyclosporine and mycophenolate mofetil after the transplant may stop     this from happening. Once the donated stem cells begin working, the patient's immune system     may see the remaining cancer cells as not belonging in the patient's body and destroy them     (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells     (donor lymphocyte infusion) may boost this effect.      PURPOSE: This phase I/II trial is studying the side effects of giving fludarabine together     with cyclophosphamide and to see how well they work in treating patients who are undergoing     donor stem cell transplant for B-cell chronic lymphocytic leukemia or Waldenström's     macroglobulinemia.   "
186751|NCT00281996|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving imatinib mesylate together with gemcitabine may kill more tumor     cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving imatinib     mesylate together with gemcitabine and to see how well they work in treating patients with     locally advanced, metastatic, or recurrent pancreatic cancer.   "
186752|NCT00282009|"     RATIONALE: Computer-assisted stop-smoking plans and telephone counseling may help people stop     smoking. It is not yet known which computer-based smoking cessation program is more effective     with or without telephone counseling in helping smokers quit smoking.      PURPOSE: This randomized clinical trial is studying two different computer-based smoking     cessation programs to compare how well they work with or without telephone counseling in     helping smokers quit smoking.   "
186753|NCT00282022|"     RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well VNP40101M works in treating patients with     recurrent or refractory locally advanced or metastatic small cell lung cancer.   "
186754|NCT00282035|"     To determine if Accelerated Partial Breast Irradiation, using 3D CRT, is as effective as     Whole Breast Irradiation following breast conserving surgery in women with an new     histological diagnosis of ductal carcinoma in situ only or invasive breast cancer without     evidence of metastatic disease. Effectiveness will be determined by the rate of ipsilateral     breast tumour recurrence.      General objective is to improve the convenience and quality of life of female patients who     receive breast irradiation.   "
186755|NCT00282048|"     To determine the activity and response rate of AG-013736 in patients with advanced and     refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).   "
186756|NCT00282061|"     This study's first aim is to widen the knowledge of the characteristics of delayed sleep     phase disorder (DSPS) by focusing on the circadian rhythms of appetite regulation factors and     their phase relations to the cycles of sleep-wake, melatonin, cortisol and body temperature.     This study's second aim is to assess the influence of forced morning awakening, as a daily     struggle faced by DSPS patients, upon the synchronization of these variables in DSPS     patients. The investigators hypothesize that the chronic incompatibility between the     endogenous sleep-wake rhythm of the DSPS patients and the morning wakefulness, as a social     demand, may impair the synchronization between the different rhythms, as findings indicate in     normal subjects under jet lag. And finally, the third aim of the study is to assess the     influence of successful treatment with melatonin upon the phase locations of circadian     rhythms of studied measures and the synchronization between them. These measures will be     assessed in a controlled study, for 36 hours (sampled every 2 hours) under three distinct     experimental conditions: first, under free sleep-wake conditions (ad-libitum bedtime and     arousal); second, under restricted sleep-wake conditions (enforced morning wake-up); and     finally, after 12 weeks of melatonin treatment.   "
186758|NCT00282087|"     The purpose of this trial is to study the benefits of giving chemotherapy to women after they     have had surgical resection of their primary disease and have no evidence of disease     remaining(known as adjuvant therapy). The major objective of this study is to determine the     progression free survival. The goal is to prevent relapse or recurrence of their uterine     leiomyosarcoma.   "
186759|NCT00282100|"     This research is being done to find how soon the liver cancer may come back and whether     proteins or genes in tumor, blood or urine can give us clues of early recurrence.   "
186760|NCT00282113|"     The purpose of this study is to see how oral preparations containing both probiotics and     prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain     fatty acid content in premature infants. Our hypothesis is that short term growth will be     improved, the stool will have more healthy bacteria, and the fecal short chain fatty acid     content will increase in the babies who receive the probiotic/prebiotic combinations compared     to control groups.   "
186761|NCT00282126|"     Osteoporosis, a disease in which the bones become weak and are more likely to break, is a     major health problem in the United States. Too much acid in the body appears to be linked to     loss of calcium via urine, bone loss, and muscle breakdown. The purpose of this study is to     determine the effect of various doses of potassium citrate, a supplement that can neutralize     acid, on bone density and muscle mass in older, healthy adults.   "
186762|NCT00282139|"     This is an open-label, flexible dose study designed to evaluate the safety and efficacy of     aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms     and with or without ADHD symptoms.   "
186958|NCT00292812|"     The study hypothesis is that different concentrations of nucleotides' supplementation of an     infant formula might affect differently growth and/or other clinical parameters in neonates.   "
186764|NCT00282165|"     In a double blind randomized clinical trial with cross-over design, treatment using     naratriptan will be compared to placebo within a group of 30 convicts with psychiatric     disorders such as psychosis or psychopathy with repeated aggressive outbursts resistant to     conventional psychopharmacologic and other psychotherapeutic treatment. Hypothesis is that     addition of naratriptan to the individual treatment regime reduces aggression -and improves     general outcome- as compared to addition of placebo and is well tolerated in this group and     under these conditions.   "
186765|NCT00282178|"     The purpose of this study is to investigate the effect of a 12-week candesartan treatment     compared with hydrochlorothiazide on insulin sensitivity assessed with hyperinsulinemic     euglycemic clamp.   "
186766|NCT00282191|"     This survey aims to investigate the prevalence of spasticity among adults who live in     community settings in Davidson County, Tennessee. The treatment of spasticity in those who     live in community homes could significantly increase a person's quality of life by allowing     them to participate more independently in activities of daily living, or by making assistance     easier for caregivers.   "
186767|NCT00282204|"     Antenatal hypnosis is associated with a reduced need for pharmacological interventions during     childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group     hypnosis preparation for childbirth in late pregnancy.   "
186768|NCT00282217|"     The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by     treatment with sirolimus, may improve renal function in renal transplant recipients with     chronic allograft nephropathy.   "
186769|NCT00282230|"     A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant     patients   "
186770|NCT00282243|"     A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable     liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression     regimen to a modified release tacrolimus based immunosuppression regimen.   "
186771|NCT00282256|"     A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable     pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen     to a modified release tacrolimus based immunosuppression regimen.   "
186772|NCT00282269|"     The purpose of this study is:        -  To determine the safety and feasibility of performing an international multi-centre          randomized control trial of early and prolonged hypothermia to improve outcome in          children with severe traumatic brain injury (TBI).        -  To determine whether in children with severe traumatic brain injury, prolonged initial          hypothermia (minimum 72 hours at 32-33 degrees) improves the proportion of good outcomes          12 months after injury when compared to initial normothermia (36-37 degrees).   "
186773|NCT00282282|"     The purpose of this study is to extend the use of Tacrolimus and Sirolimus to determine how     effective it is in preventing graft versus host disease (GVHD)in patients that have received     non-myeloablative peripheral blood stem cell transplantation.   "
186774|NCT00282295|"     New immunization recommendations in the US include vaccination of adolescents against     pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the     Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced     Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate     vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the     same office visit if vaccination with both vaccines is indicated. Therefore, this study is     designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix     co-administered with Menactra as compared to the administration of either vaccine alone in     healthy adolescents 11 - 18 years of age.   "
186775|NCT00282308|"     This was a Phase II, randomized, open-label, multicenter study designed to evaluate the     immune response to vaccines after administration of 1000 mg of rituximab in subjects with     active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).   "
186776|NCT00282321|"     We wanted to test urinary concentrating ability and AQP-2 expression in kidney during     high-protein and high-carbohydrate diet.   "
186777|NCT00282334|"     The aim of the study is to compare telemedical antihypertensive treatment based on home blood     pressure monitoring and conventional antihypertensive treatment based on monitoring of blood     pressure in the doctor's office.      We want to test the hypotheses that telemedical treatment is more effective in lowering blood     pressure, provide better quality of life and is more cost-effective.   "
186780|NCT00282373|"     The primary objectives of this study are to determine the safety and feasibility of inducing     mild hypothermia using a non-invasive thermoregulatory device, the Medivance Arctic Sun     Temperature Management System, in patients resuscitated after cardiac arrest.   "
186781|NCT00282386|"     This study was to compare the effect of 156 weeks of treatment with MK-0966 (Rofecoxib)     versus placebo on the recurrence of colorectal adenomas (growths that occur on the inside     (the lining) of the large intestine, also known as the colon) in patients with a history of     colorectal adenomas.   "
186782|NCT00282399|"     The purpose of this study was to determine which of the doses of decitabine maximizes genomic     demethylation in patients with Myelodysplastic Syndrome (MDS).   "
186793|NCT00282542|"     The purpose of this study is to gain knowledge about the result of infusing liver cells,     carefully matched to blood type, into a subject's body. The hope is that this procedure will     aid functions of the liver and prevent death, enable a transplant procedure to be carried out     if a donated liver becomes available, and lessen complications in postoperative recovery.     There is no guarantee that any of these benefits will be re eived, but even if they are not,     the hope is that knowledge gained by using this procedure will be of future benefit to others     who also suffer from liver disease.   "
186783|NCT00282412|"     Rheumatoid arthritis disease is believed to be due to immune cells, cells that normally     protect the body and are now causing damage to the body. Risk of death is highest in people     with twenty or more joints actively involved with disease, positive rheumatoid factor, an     elevated sedimentation rate (laboratory measures of active inflammation), and patients with     limitation of daily activities (trouble doing simple things like opening a carton of milk).     In these high risk patients, life is significantly shortened. Death is usually from heart     disease, kidney failure, neck dislocation, broken hip bones, or blood clots to the lung. In     this study we use moderate dose chemotherapy (cyclophosphamide and fludarabine) and     CAMPATH-1H (a protein that kills the immune cells that are thought to be causing the     disease), followed by infusion of blood stem cells that have been collected from the     patient's brother or sister (allogeneic stem cell transplant). The purpose of the moderate     dose chemotherapy and CAMPATH-1H is to destroy the cells in the immune system and to allow     the cells from the patient's brother or sister to grow. The purpose of the stem cell infusion     is to restore blood cell production, which will be severely impaired by the moderate dose     chemotherapy and CAMPATH-1H, and to produce a normal immune system that will no longer attack     the body.   "
186784|NCT00282425|"     Scleroderma is disease believed to be due to immune cells, cells which normally protect the     body but are now causing damage to the body. There has not been any treatment that has been     effective in treating this disease. The likelihood of progression of the disease to severe     disability and death is high. This study is designed to examine whether treating patients     with high dose Cyclophosphamide and Fludarabine (drugs which reduce the function of your     immune system) and CAMPATH-1H (a protein that kills the immune cells that are thought to be     causing the disease), followed by return of blood stem cells that have been previously     collected from patients brother or sister will stop or reverse the disease. The purpose of     the Cyclophosphamide, Fludarabine and CAMPATH-1H is to decrease immune system. The purpose of     the stem cell infusion is to restore blood production, which will be severely impaired by the     Cyclophosphamide, Fludarabine and CAMPATH-1H, and to produce a normal immune system that will     no longer attack the body.   "
186785|NCT00282438|"     Sarcoidosis is a disease believed to be due to immune cells, cells which normally protect the     body, but are now attacking lungs, heart, nerves, or other organs or systems within the body.     As a result, the affected organs or systems fail to work properly causing difficulty     breathing; heart failure; inability of the nerves to respond properly causing numbing,     tingling, pain, and progressive muscle weakness; or other symptoms depending on the organ or     body system involved. The likelihood of progression of this disease is high. This study is     designed to examine whether treating patients with high dose cyclophosphamide (a drug which     reduces the function of the immune system) and ATG (a protein that kills the immune cells     that are thought to be causing this disease), followed by return of the previously collected     blood stem cells will stop the progression of sarcoidosis. Stem cells are undeveloped cells     that have the capacity to grow into mature blood cells, which normally circulate in the blood     stream. The purpose of the high dose cyclophosphamide and ATG is to destroy the cells in the     immune system. The purpose of the stem cell infusion is to evaluate whether this treatment     will produce a normal immune system that will no longer attack the body.   "
186786|NCT00282451|"     This trial is conducted in Africa and Middle East. The objective of the study is to compare     glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30     twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in     subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.   "
186787|NCT00282464|"     This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in     outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are     required to undergo a washout period of at least 7 days of any prior med.   "
186788|NCT00282477|"     Bicycle riding is associated with related diverse urogenital symptoms ranging from genital     numbness to erectile dysfunction (ED). Very little is known about the quality of sperm in     cyclists and whether a connection exists between erectile dysfunction and azoospermia.   "
186789|NCT00282490|"     The purpose of this study is to perform a randomized controlled investigation of the effect     of surface nerve stimulation on functional daytime incontinence in children with OAB.   "
186790|NCT00282503|"     The purpose of this study is to compare the safety and efficacy of ECP treatment combined     with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of     patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days     following an allo HPCT.   "
186791|NCT00282516|"     OBJECTIVE: Determine whether home asthma telemonitoring using store-and-forward technology     improves outcomes when compared to in-person, office-based visits.   "
186836|NCT00291096|"     The overall goal of this project is to develop an integrative system of breast cancer risk     assessment based on epidemiologic and biologic risk variables, as well as to develop or     refine risk biomarkers which may be useful in predicting and monitoring response to     prevention interventions.   "
186792|NCT00282529|"     The proposed research is designed to establish lymphedema incidence rates for a varied     population of breast cancer patients. Patients with breast preservation, mastectomy, sentinel     lymph node biopsy, axillary dissection and radiation therapy will be included with the goal     of determining the impact that each of these treatments has on development of lymphedema.     Establishing incidence in these populations is crucial to the remainder of the study. We     conduct a two phase study. The first phase will use arm measurements, a symptom survey (The     Lymphedema and Breast Questionnaire), a functional survey (Disability of the Arm, Shoulder,     and Hand Questionnaire), and operative and pathology information to create a simple screening     tool to predict the development of lymphedema. Currently, lymphedema is only diagnosed after     arm swelling develops. The goal of the screening tool is to identify those patients at     significantly increased risk for development of lymphedema as compared to the general     population of breast cancer survivors. Phase 2 of the study will test a lymphedema prevention     strategy in a high risk population. The goal of this phase is to reduce the incidence of     lymphedema in those patients that have undergone an axillary node dissection with radiation     therapy by using a combination of education, a compression sleeve and decongestive exercises.     If prevention is successful, the development of a screening tool becomes even more important     to identify those patients that should undergo a prevention regimen.   "
186907|NCT00292045|"     This is an open-label, fixed-dose study of immunization with NY-ESO-1 protein combined with     CpG as adjuvant in patients with high-risk stage D1 or advanced prostate cancer      Eligible patients will receive vaccinations consisting of 100µg NY-ESO-1 protein combined     with 2.5mg CpG administered intradermally every 3 weeks for 4 doses.   "
186794|NCT00282555|"     STU-Na belongs to the proton pump inhibitors (PPI), a group of drugs that reduce gastric     acidity. PPI are used to treat acid related diseases like erosive or ulcerative esophagitis.     This trial aims to find out the therapeutic dose of STU-Na required for healing patients with     erosive or ulcerative esophagitis. One of four dosages of STU-Na (15 mg, 30 mg, 60 mg, or 90     mg daily), or Esomeprazole 40 mg daily, an already marketed PPI, will be given to patients.     The attribution to one of the 5 treatment groups will be by chance. Neither the patient nor     the study physician will know, which treatment is administered to the patient.   "
186795|NCT00282568|"     A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable     kidney transplant patients converted from a Prograf® based immunosuppression regimen to a     modified release tacrolimus based immunosuppression regimen.   "
186796|NCT00282581|"     The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox     vaccine injections in healthy adults that are 18-35 years of age with HIV infection   "
186797|NCT00282594|"     We sought to determine if there is a benefit to using an insulin drip to control     hyperglycemia in the surgical critical care unit for patients who undergo general and     vascular surgery.   "
186798|NCT00282607|"     The purpose of this study will be to evaluate the clinical efficacy and safety of DA-8159, an     orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment     of subjects with erectile dysfunction (ED).   "
186799|NCT00282620|"     This study is being conducted to see if magnesium can reduce the number of shocks patients     with ICDs experience and to see if magnesium supplementation improves patients quality of     life.   "
186800|NCT00282633|"     A Comparison of Skin Closure Techniques after Primary Cesarean Delivery. Traci N. Gray, M.D.     and Peter F. Schnatz, D.O.      A prospective, observer blinded, randomized, and controlled trial comparing Dermabond closure     technique to suture closure of skin.      Study Participants: All women age 18years or older who provide informed consent prior to     primary Cesarean delivery at Hartford Hospital. Women with vertical skin incisions and or who     are febrile preop or intraop will be excluded.      Methods: Qualified participants will then be randomized to skin closure with either Dermabond     or suture. Surgeon preference will dictate usage of 4-0 monocryl or 4-0 vicryl for skin     closure for patients randomized to the suture arm.        -  The circulating nurse will time all skin closures.        -  The surgeon will complete a 3 question survey immediately postop.        -  At the 6 week post partum visit, patients and the health care professional will complete          a brief query regarding cosmetic appeal and pain. A disposable camera will be supplied          to each provider office and a photo will be taken of the incision.        -  All photos will be evaluated for cosmesis by physicians who will be blinded to the          methods of skin closure.      Primary Outcomes: To compare the time needed to close skin. To compare cosmetic outcome after     healing      Secondary Outcomes: Patient Pain scores. Provider and patient satisfaction. Responses to     questions.   "
186801|NCT00282646|"     Patients with peripheral artery disease, stage III or IV who are not candidates for     interventional or operative therapy should be treated with intraarterial progenitor cell     therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.   "
186802|NCT00282659|"     The purpose of this study is to determine if magnesium can improve blood pressure,     cholesterol, and blood sugar control in patients with implantable cardioverter defibrillators     (ICDs).   "
186803|NCT00282672|"     The purpose of this study is to determine if the intervention of a 510(k)-cleared     endoscopically-guided (Halo Ablation systems), ablation system plus anti-secretory therapy is     better than anti-secretory therapy alone in clearing Barrett's Esophagus.   "
186804|NCT00282685|"     Treatment of patients with diabetic neuropathy by intraarterial progenitor cell     transplantation.   "
186805|NCT00282698|"     Patients with or without diabetes may have high blood sugar levels due to stress response of     the body during heart surgery. This study is being done to determine if maintaining normal     blood sugar levels during open-heart surgery by using intravenous insulin results in a lesser     incidence of death, wound infections in the chest, disturbances of heart rhythm, kidney     failure, stroke and prolonged time on the breathing machine (artificial ventilation) within     30 days after surgery.   "
186806|NCT00288249|"     The purpose of this study is to determine whether the study drug is effective and safe in the     treatment of patients with metastatic breast cancer   "
186837|NCT00291109|"     To assess the quantitative real time PCR results of oligonucleotide probes for a number of     gene transcription products that may be useful as predictors or indicators of response to     letrozole   "
186807|NCT00288262|"     In many mammals, the duration of the nocturnal melatonin elevation regulates seasonal changes     in reproductive hormones such as luteinizing hormone (LH). Melatonin's effects on human     reproductive endocrinology are uncertain. It is thought that the same hypothalamic pulse     generator may both trigger the pulsatile release of GnRH and LH and also cause hot flashes.     Thus, if melatonin suppressed this pulse generator in postmenopausal women, it might moderate     hot flashes. This clinical trial tested the hypothesis that melatonin could suppress LH and     relieve hot flashes.   "
186808|NCT00288275|"     Chemoresponse assays (lab test) measure the effect that chemotherapy treatment has on a     patient's cancer cells in the lab. This test has shown success in a retrospective study in     predicting how an individual patient's tumor will respond to a given chemotherapy and how     treatment utilizing an agent that the test said that a patient's cells would be sensitive too     corresponds to a longer progression free interval. This study will determine the ability of     two tests used to predict the success of chemotherapy in recurrent, persistent, or refractory     cancer of the ovaries, fallopian tube(s) or peritoneum by measuring how long patients live     without progression.   "
186809|NCT00288288|"     The primary purpose of this study is to compare the time, risk and cost savings of 2 patient     groups who receive FDA approved left ventricular pacing leads.   "
186810|NCT00288301|"     The purpose of this study is to test the effectiveness of a weight loss and weight loss     maintenance intervention among low income women, conducted in a community health center     setting.   "
186851|NCT00291317|"     Regular exercise is strongly recommended to help maintain a healthy lifestyle. Unfortunately,     children and young adults with damaged spinal cords may not be able to exercise regularly.     However, there is an exercise bike specially designed for persons with damaged spinal cords     that enables them to pedal by directly stimulating the muscles in their legs. Our study is     designed to determine the benefits of exercise for Spinal Cord Injured (SCI) patients using     this bike.   "
186811|NCT00288314|"     Neuropsychological studies investigating trauma-exposed and posttraumatic stress disorder     (PTSD) subjects have generally underlined the significantly poorer performance of tasks that     require attention, concentration, and verbal memory, and difficulty in regulating memories     surrounding the traumatic event. A previous study (El Hage et al. Cognitive Neuropsychiatry,     2006) revealed that the trauma-exposed subjects scored higher on anxiety/depression scales,     and lower on processing speed tests. Moreover, the study showed significant impairment in     working memory partially mediated by speed processing, but not by anxiety or depression.     These results suggest that processing speed makes a major contribution to trauma-related     working memory decline, and needs to be investigated in further studies.The aim of the     present study is to explore correlation between hippocampus volume, frontal dysfunction and     cognitive slowing in trauma-exposed subjects, while examining brain activation during     performance of working memory tasks using functional magnetic resonance.   "
186812|NCT00288327|"     The overall aim of the study was to test the feasibility and effectiveness of a     cardiovascular disease risk reduction intervention program for midlife, low-income women. We     enhanced an existing nutrition and physical activity intervention tool, A New Leaf...Choices     for Healthy Living, which was designed specifically for this demographic group as part of the     CDC's WISEWOMAN Program. The enhanced intervention was tested in a randomized controlled     trial in a community health center setting.   "
186813|NCT00288340|"     The goal of the project is to characterize abnormalities in brain structure and function     related to schizophrenia. The investigators will use advanced magnetic resonance imaging     (MRI) techniques to measure the degree and distribution of neuronal activity during specific     cognitive tasks, alterations in neuronal connectivity, and how these are related to disease     symptoms and treatment.   "
186814|NCT00288353|"     The primary goal of this study is to examine the triglyceride/HDL ratio and the ischemic EKG     changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.   "
186815|NCT00288366|"     The objective of this study is to determine the effect of various mood stabilizers (MS) on     the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in     patients treated with antipsychotic drugs (APDs). Patients will be switched from their     current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless     clinically contraindicated) for comparison with metabolic levels during treatment with the     former medication.      The metabolic syndrome is an empirical concept based on extensive evidence that a     constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low     HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of     cancer.   "
186816|NCT00288379|"     To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of     formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of     inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild     asthma   "
186817|NCT00288392|"     The purpose of this study is to evaluate the efficacy of soluble beta-1,3/1,6-glucan compared     to placebo on the healing of chronic leg ulcers in diabetes patients.      Hypothesis: Through its ability to activate tissue macrophages and counteract     diabetes-associated defects in macrophages, the soluble beta-1,3/1,6-glucan will promote the     healing of leg ulcers in diabetic patients.   "
186818|NCT00288405|"     To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent     System to facilitate endovascular coil embolization of wide neck saccular intracranial     aneurysms.      Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck,     intracranial, saccular aneurysms arising from a parent vessel   "
186819|NCT00288418|"     The main purpose of this study is to determine if the Angiotech central venous catheter (CVC)     is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in     preventing bacterial catheter colonization. Other objectives of this study are to determine     if the Angiotech CVC is equal in effectiveness to a CVC coated with chlorhexidine and silver     sulfadiazine in preventing catheter-related local infection, and catheter-related bloodstream     infection. This study will also assess the safety of the Angiotech CVC.   "
186820|NCT00288431|"     This study is designed to determine the safety, tolerability and maximum tolerated dose of     Oral AP23573 in combination with Doxorubicin   "
186821|NCT00288444|"     To determine the molecular interaction in tumor samples between docetaxel and lonafarnib.   "
186824|NCT00288483|"     Despite undeniable progress in the reduction of morbidity and mortality of coronary heart     disease (CHD) prevention is a mainstay for medical intervention. The importance of elevated     serum cholesterol for the formation and progress of CHD can be regarded as proved after the     results of the major intervention studies became available. These studies have provided key     evidence for a positive correlation of lipid lowering and decreased mortality. Other studies     in patients with established CHD have shown that stabilization and regression of     atherosclerotic lesions is possible with lowering of cholesterol using a variety of agents.     Different studies have also investigated the long-term effects of lipid lowering strategies     on atherosclerosis by means of coronary angiography and have demonstrated that lipid     reduction reduces progression of atherosclerosis and can promote atherosclerosis regression.     Thus, it has been demonstrated that cholesterol lowering therapy reduces the risk of CHD and     diminishes cardiovascular morbidity and mortality.      Policosanol is a drug that presumably possesses both hypocholesterolemic and antiplatelet     effects. Furthermore there are hints to even more positive effects that influence the     development of atherosclerosis, i.e. inhibition of LDL peroxidation and smooth muscle cell     proliferation.      Previous studies showed efficacy in dose ranges of mostly 5 to 20 mg Policosanol per day. As     nearly all previous studies have been performed in Latin America it cannot be excluded that     either ethnic or nutritional factors contribute to the dose found to be optimal in this     region. This circumstance as well as the requirement to meet the ICH Guideline “Ethnic     Factors in the Acceptability of Foreign Clinical Data” make further studies, i.e. a     dose-finding clinical trial, an efficacy clinical trial in European patients and a long-term     tolerability clinical trial in Caucasian patients necessary.      It is known from more than 60 clinical studies performed so far that Policosanol has an     excellent safety profile. A placebo-controlled design was considered appropriate as patients     with two or more risk factors for the development of cardiovascular events and a LDL of     greater than 190 mg/dl were excluded; the chance of getting an active lipid-lowering agent     during the treatment phase was 80 %.   "
186906|NCT00292032|"     The CASPER will collect systematic clinical assessments of patients and families within the     multicenter Canadian Inherited Heart Rhythm Research Network. Unexplained Cardiac Arrest     patients and family members will undergo standardized testing for evidence of primary     electrical disease and latent cardiomyopathy along with clinical genetics screening of     affected individuals based on an evident or unmasked phenotype.   "
186825|NCT00288496|"     Mechanical bowel preparation (MBP) is common practice in elective colorectal surgery. In     recent literature the value of MBP is subject of discussion. We conducted a multicenter,     randomized study with the goal of comparing outcome of elective colorectal resections and     primary anastomoses with and without mechanical bowel preparation in terms of anastomotic     leakage and other septic complications.      Within the setting of a multicenter randomized trial,1433 patients were randomized before     elective colorectal surgery to receive either MBP or to have no MBP but a normal meal on the     day before operation. The primary endpoint was anastomotic leakage. Secondary endpoints were     septic complications (wound infection, urinary infection, pneumonia, pelvic abscesses),     fascia dehiscence and death.      The incidence of anastomotic leakage was similar in both groups: 5.1% in patients without MBP     versus 4.9% in patients with MBP (p=0.93; 95% confidence interval for the difference (no MBP     minus MBP) ranges from –2.3% tot +2.7%). There were no significant differences in other     septic complications, fascia dehiscence, or mortality. Fecal contamination, number of days     until resumption of a normal diet, and duration of hospital stay were similar in both groups.      This study shows that elective colorectal surgery can be safely done without MBP. Therefore,     MBP should be abandoned in elective colorectal surgery.   "
186826|NCT00288509|"     The aim of this study is to assess longer term safety and effectiveness of Dysport®.   "
186827|NCT00288522|"     The main purpose of this study is to evaluate the efficacy and safety of 3 doses of     Somatuline Autogel 60mg to control the muscle infiltration and edema, eyelid retraction and     extraocular muscular contraction in patients with active thyroid-associated ophthalmopathy of     moderate intensity.   "
186828|NCT00288535|"     This study is a prospective, randomized, single-center evaluation of the Cypher™ Sirolimus     eluting coronary stent system in the treatment of de novo bifurcated coronary lesions     comparing provisional modified T stenting with systematic modified T-stenting.   "
186829|NCT00288548|"     We want to study the effect of the combination of metoprolol (a beta-blocker) with formoterol     (a beta-agonist) on long function in patients with Chronic Obstructive Pulmonary Disease     (COPD). There are more and more clues that a beta-blocker, when well chosen and in the right     dosage, won't harm the long function in patients with COPD. Since a beta-blocker can be a     valuable addition to treating patients with heart problems we would like to see if this     category of medication can be available for COPD patients in the future.   "
186830|NCT00288561|"     Ranibizumab is derived from a murine monoclonal anti- vascular endothelial growth factor     (VEGF) antibody and can penetrate through the many retinal cell layers following intravitreal     injection. The present study is directed towards the assessment of ranibizumab administered     on the same day in combination with verteporfin in patients with subfoveal CNV secondary to     ARMD   "
186831|NCT00288574|"     This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate     of relapse of anorexia nervosa (AN) and enhancing the psychosocial and behavioral recovery of     people who have been treated for AN.   "
186832|NCT00291044|"     Brief summary: The current management guidelines recommended by ACOG rely on history as a     screening method to determine pregnant women who are at risk for transmitting herpes to their     newborn. History fails completely in identifying the women most at risk of transmitting     herpes to their newborn - the seronegative woman who acquires a primary infection from her     partner during pregnancy. Despite recent advances, both pregnant women and newborns continue     to be at risk of acquiring herpes infection. Genital herpes infections are epidemic in the     United States. In the early 1990's, 25% of women in the US were seropositive for the HSV-2     antibody. These numbers are likely higher now. The incidence of neonatal herpes in the US     cannot be accurately estimated since it is not a reportable disease. However, in some areas     of the US, the incidence is 1 in 3,200 live births which would translate to an incidence of     approximately three infants a day in the US . In other areas of the US, the incidence is even     higher, approaching 1 in 1,500 liveborns. This protocol examines patient acceptance of HSV-1     and HSV-2 type specific serologic testing and assesses patient counseling tools. In addition,     seroprevalence of HSV-2 in pregnant patients will be collected and evaluated.   "
186833|NCT00291057|"     In a previous phase II study, the safety and efficacy of a novel formulation of malathion     0.5% was evaluated in patients 2 years of age and older. Based on the results of that study,     this formulation is currently in a phase III study for that population.      The current study will use blood markers and clinical evaluations to determine the safety and     tolerability of this formulation when used in children 6-24 months of age.   "
186834|NCT00291070|"     This study will examine the effects of L-theanine (an amino acid found in green tea) on the     behavior, cognitive performance and sleep quality of boys with ADHD.   "
186840|NCT00291148|"     This is a comparative drug trial involving patients with clinically definite Multiple     Sclerosis and documented neuropathic pain. Patients will be randomized to receive treatment     with either paroxetine or pregabalin. After dose titration, participants will complete     various pain scale assessments at several points during the study in order to determine the     effectiveness of their assigned pain medication.   "
186908|NCT00292058|"     Psychiatric consultation and short-term follow-up will produce equivalent clinical outcomes     and be less costly when provided via videoconferencing (telepsychiatry) than when provided     in-person.   "
186841|NCT00291161|"     Background: Partners in Dementia Care (PDC) is a care coordination and support service     intervention for veterans with dementia and their family caregivers, delivered through     partnerships between VA medical centers and local Alzheimer's Association Chapters. PDC was     designed to be a feasible and practical intervention to integrate health, community, and     support services. PDC has a standardized protocol for care coordination and support services,     including guidelines for care plan assessment, care plan development and implementation,     ongoing monitoring, and reassessment. It also offers a structured training curriculum for     providers and an operations manual for uniform implementation.      Objectives: The primary objective was to test the impact of PDC on outcomes for veterans with     dementia and family caregivers. Two specific research objectives and corresponding hypotheses     were addressed: 1. To test the impact of PDC on three categories of outcomes: psychosocial     well-being outcomes (patient and caregiver effects); health care service use (patient effects     only); and health care cost (patient effects only). HI:PDC, compared to usual care, will     improve psychosocial well-being for patients with dementia and their caregivers. H2:PDC,     compared to usual care, will reduce health care service use for patients with dementia.     H3:PDC is preferred to usual care based on cost-benefit analyses. H4:The PDC intervention     will be more effective in improving psychosocial well-being and reducing health care service     use for patients and caregivers dealing with more severe patient impairment (e.g., cognitive     status, functional status, and level of problem behaviors). 2. To evaluate the impact of PDC     on role and intra-psychic strains caused by dementia and its care (patient and caregiver     effects). H5a:PDC, compared to usual care, will decrease patient role and intra-psychic     strain. H5b:PDC, compared to usual care, will decrease caregiver role and intra-psychic     strain. H6:The PDC intervention will be more effective in decreasing role and intra-psychic     strains for patients and caregivers dealing with more severe patient impairment (e.g.,     cognitive status, functional status, and level of problem behaviors).   "
186842|NCT00291174|"     This is a research study to evaluate the electrical properties of heart tissue. The purpose     of this study is to determine the impedance (electrical resistance) of different tissues on     the outer surface of the heart. This may be important for distinguishing scarred heart muscle     from fat that can be seen on the surface of the heart. This information may eventually be     utilized in patients that undergo a procedure (called catheter ablation) for the treatment of     life-threatening heart rhythms. Investigators expect a detectable difference between the     impedance of normal and infarcted myocardium (approximately 50 ohms).   "
186843|NCT00291187|"     The purpose of this study is to determine the safety and efficacy of VEC-162 compared to     placebo to improve sleep parameters in a model of insomnia.   "
186844|NCT00291200|"     This study will gather information on the natural history of the basic symptoms of psychosis     to identify factors that may affect the improvement or persistence of the symptoms.   "
186845|NCT00291213|"     This is a placebo-controlled study designed to learn if levetiracetam is effective for     tardive dyskinesia.   "
186846|NCT00291226|"     Glycine is a natural amino acid neurotransmitter that acts as a co-agonist at NMDA receptors     in brain. We hypothesize that symptoms of the schizophrenia prodrome will improve with     glycine to a greater degree than with placebo.   "
186847|NCT00291239|"     40 patients with the diagnosis of major depression are included. There are two interventions:     partial sleep deprivation (PSD) and normal night sleep (CTRL). Patients are randomly assigned     to PSD-(2 undisturbed nights)-CTRL or CTRL-(2 undisturbed nights)-PSD. Cytokine-status,     neuropsychological and psychopathometric status are assessed pre and post each interventional     and control condition.   "
186848|NCT00291265|"     This study will test the accuracy of a new home-use electronic device that measures and     records small changes in Parkinson's disease symptoms, such as tremor and impaired movement     and speech. The testing is done at home and the results are sent by Internet to the patient's     doctor. Detecting Parkinson's disease in its early stages may permit doctors to provide early     treatment and slow the rate of disease progression.      Patients with early Parkinson's disease (less than 5 years) with rest tremors and     bradykinesia (slowness and difficulty of movement) who are not taking medications for the     disease may be eligible for this study. Candidates are screened with training and practice in     using the home monitoring device over 2-3 weeks. Those who demonstrate proficiency with the     device may be enrolled in the study.      Participants undergo the following tests and procedures:      Baseline Visit      Participants' undergo symptoms ratings using the Unified Parkinson's Disease Rating Scale and     assessments of memory, thinking and depression.      At-home testing      Participants begin at-home testing with the monitoring device after the baseline visit and     repeat the tests weekly for 6 months. The test information is automatically uploaded to a     home computer (provided by the study) and sent to the investigators via Internet. The test     procedure is as follows:        -  Introduction questionnaire (1 minute): Participants are questioned about how they are          feeling at test time.        -  Pegboard test (4 minutes): At the sound of a tone, the participant moves eight pegs from          the right to the left using their right and then left hand.        -  Tapping test (3 minutes): At the sound of a tone, the participant alternately presses          two buttons with the right index finger and then the left index finger.        -  Reaction time/movement time testing (3 minutes): At the sound of a tone, the participant          moves his or her index finger from one button to the other, first with the right hand          and then with the left hand.        -  Digitography testing (4 minutes): At the sound of a tone, the participant alternates          between pressing two keys with the index and middle fingers.        -  Speech + Actiwatch tremor data upload (7 minutes): The participant: 1) takes a deep          breath and says ahhh for as long as possible; 2) is shown a picture and, at the sound          of a tone, is asked to tell a story about the picture; 3) uploads the tremor data from          the Actiwatch (a device worn on the wrist that records tremors).        -  At specified times du...   "
186849|NCT00291278|"     This study will compare bone mass in women with a history of endometriosis, a disease in     which the lining of the uterus grows on nearby tissues, to that of women who have not had     endometriosis. Endometriosis may be treated with medication or surgery, or both. Because     uterine tissue grows more when estrogen levels are high, medical treatment is designed to     lower estrogen. Decreased estrogen, however, is often associated with weak bones and hot     flashes. Also, women with endometriosis may have lower bone density as a consequence of their     disease. This study will look at bone density in these women, particularly to see if areas     other than the lower back may be affected.      Regularly menstruating women between 40 and 50 years old, with or without a history of     endometriosis, may be eligible for this study. Candidates are screened by telephone; women     with endometriosis are asked to provide documentation of their endometriosis before beginning     the study.      Study participants undergo the following tests and procedures:        -  Medical history and blood sample collection        -  Questionnaires about exercise activity, calcium intake, menstrual cycle history,          cigarette use and medication history        -  DEXA scan: This test evaluates the strength of the bones in the back, wrist, and hip.          The DEXA scanner uses low-energy x-rays to determine bone density. Scans are done of the          lower spine, upper thigh, hip, and the entire body. For the test, the subject lies on          the scanning table. Each scan takes about 3 minutes, and the entire procedure may take          as long as 1 hour.   "
186865|NCT00291499|"     The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg     tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint     osteoarthritis.      Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's     Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during     the treatment with the tested product, Condrosulf®, versus placebo.   "
186850|NCT00291304|"     Magnetic Resonance Imaging (MRI) is a well known imaging tool for the investigation and     diagnosis of breast cancer, used in addition to breast mammograms and ultrasound. Recent     publications suggest that MRI may be the best test to use in women who have very dense     breasts, have a family history of breast cancer and have had breast cancer and were treated     with breast saving measures. MRI has been shown to be a better tool to show multiple breast     cancer spots than mammography or ultrasound. The radiologists and the radiology students will     have the opportunity to review the MRI scans along with the breast ultrasound and mammography     films and the pathology reports from the breast cancer surgery completed at the CCI. This may     enable them to learn how the various subtypes of breast cancer look on MRI. The goal is: 1)     to gain good breast MRI expertise, giving the Radiology residents a complete diagnostic     program. 2) to develop good MRI breast experience, enabling the Cross Cancer Institute to be     the centre of excellence for Breast MRI for northern Alberta.   "
186852|NCT00291330|"     The purpose of this trial is to determine the comparative safety and efficacy of dabigatran     etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to     maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute     symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a     parenteral anticoagulant approved for this indication. This trial aims to demonstrate     non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE.     After achieving non-inferiority, this trial also aims to establish superiority (by means of     hierarchical tests) of dabigatran over warfarin.   "
186853|NCT00291343|"     This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of     age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™     ACWY full dose stage at 24 to 30 months of age all subjects will receive a dose of     Mencevax™ ACWY. In the Mencevax™ ACWY small dose stage at 30 to 36 months of age, the first     75 subjects in each of the two centers will be tested for boostability of the MenA and MenC     immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting     has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
186854|NCT00291356|"     This is a study to compare the safety, blood concentrations, and effects of GSK189075,     GW869682, and placebo when dosed for 2-weeks by mouth to patients with type 2 diabetes.   "
186855|NCT00291369|"     The PERCY Quattro trial has been designed to evaluate the survival benefit of two cytokine     treatments, Interleukin-2 (IL2) and/or alpha interferon (IFN), for patients with intermediate     chance of response in metastatic renal cell carcinoma.      Eligible patients will be randomly assigned in a two-by-two factorial design to either     medroxyprogesterone (MPA), subcutaneous IFN, subcutaneous IL2, or a combination of IFN and     IL2.      The primary objective of the study is overall survival; secondary objectives are     progression-free survival, response rate, toxicity, and quality of life.   "
186856|NCT00291382|"     This double-blind, stratified, parallel group study is to determine whether aiming for 'Total     control' results in better airway hyper-responsiveness than maintaining the treatment level     at which 'Well-controlled' asthma was achieved. The primary endpoint is the mean change in     PC20 methacholine. Well controlled subjects (as assessed after a 12 week run-in period) will     enter a 24 week treatment period during which they will record PEF(Peak Expiratory Flow),     symptoms, rescue beta2-agonist use over 24 hours, night time awakenings, asthma     exacerbations, emergency visits due to asthma and Adverse Events. At every visit lung     function measurements and airway hyper-responsiveness will be measured.   "
186857|NCT00291395|"     Before , during and after intravenous administration of PGI2 we score/measure headache, rCBF,     blood flow in middle cerebral artery and diameter of superficial temporal artery/radial     artery and correlate that to known patophysiology of headache to see if PGI2 is involved in     headache pathophysiology.   "
186858|NCT00291408|"     The purpose of the study is to compare histone acetyltransferase (HAT) and histone     deacetylase (HDAC) expressions and activities in induced sputum macrophages obtained from     patients with moderate to severe COPD and age-matched normal non-smokers   "
186859|NCT00291421|"     The purpose of this study is to collect and compare information regarding the treatment and     outcome of patients diagnosed with Alzheimer's disease who are receiving either drug or     nondrug treatment. Information will be collected from patients and their primary caregivers.   "
186860|NCT00291434|"     The aim of our study was to evaluate the value of two different altered fractionation     schedules – hyperfractionation and accelerated fractionation with concomitant boost – in     comparison with conventional fractionation in primary definitive radiotherapy for squamous     cell carcinomas of the larynx, oropharynx or hypopharynx. The study began and was conducted     while the only teletherapy unit in our department was the cobalt-60 machine. During that     period we were expecting the installation of new sophisticated equipment. We assumed that the     results of this study would be also able to show whether or not it would be rational to use     the altered fractionation regimens on the new machines.   "
186861|NCT00291447|"     The purpose of this clinical trial is to describe the toxicity, biodistribution,     pharmacokinetics and tumour uptake of a single infusion of ch806 (tagged with a trace amount     of radioactive 111-Indium: 111In-ch806) in patients with advanced tumours expressing the 806     antigen.   "
186862|NCT00291460|"     The trial intends to investigate, whether inspiratory muscle training in hypercapnic patients     improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk     within six minutes.   "
186863|NCT00291473|"     Mixed cancer vaccines, CHP-HER2 protein and CHP-NY-ESO-1 protein, are to be studied to     evaluate the safety and immune responses in patients who are positive either or both     antigens. Nine patients will be enrolled, who are refractory to standard therapies for cancer     or at high risk to relapse. CHP-HER2 and CHP-NY-ESO-1 are subcutaneously given on bimonthly     basis, together with OK-432(Picibanil) as an immunoadjuvant. Six doses will be given.     Toxicity profiles will be monitored, and antigen specific humoral anad T cell responses will     be described.   "
186864|NCT00291486|"     The purpose of this clinical trial is to determine whether it is safe to treat patients with     advanced colorectal cancer, with humanised A33 antibody tagged with radioactive iodine     (131I-huA33) in combination with chemotherapy (capecitabine).   "
186866|NCT00291512|"     This project studies the effectiveness of a sexual risk reduction intervention among HIV+ Men     who have Sex with Men (MSM) and who use methamphetamine.   "
186867|NCT00291525|"     Various patient groups with the On-X Valve can be maintained safely on lower doses of blood     thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard     dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.   "
186909|NCT00292071|"     This is an open-label study of MK0991 in children between 3 to 24 months of age with new     onset fever and neutropenia. The purpose of the study is to investigate plasma drug levels of     caspofungin.   "
186868|NCT00291538|"     In this open-label randomised phase I trial, bortezomib will be administrated to 2 groups of     10 patients with MM who have inclusion criteria use the extended 2nd line indication, either     intravenously (group 1 = 10 patients) or subcutaneously (group 2 = 10 patients). The schedule     of administration of bortezomib will be the following : 1.3 mg per square meter of     body-surface area twice weekly for 2 weeks, followed by 1 week without treatment, for up to     eight cycles, either IV (group 1) or SC (group 2).      The primary objective is to characterize the pharmacokinetics of the 2 routes of     administration.      The secondary objectives are to characterize the pharmacodynamics (20S proteasome inhibition     in whole blood), toxicity, including cardiac safety, and efficacy of the 2 routes of     administration.   "
186869|NCT00291551|"     This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor     Ventricular Support System when used to treat patients with heart failure. The implant, which     is loaded onto the delivery system, is placed over the epicardial surface of the right and     left ventricles.      No formal hypothesis testing will be performed; descriptive statistics will be used to     summarize patient outcomes. The results of the study will be used to guide the design and     sample size estimation of future studies.   "
186870|NCT00291564|"     The purpose of this study is to gather information on how doctors program particular settings     on cardiac resynchronization therapy implantable cardiac defibrillators (CRT-Ds), to analyze     how these settings affect the amount of cardiac resynchronization therapy (CRT) patients     receive and to evaluate the therapy approach for converting abnormally fast heartbeats into     normal heartbeats. There are no experimental devices or procedures involved in this study.   "
186871|NCT00291577|"     This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with     docetaxel in patients with metastatic or locally recurrent breast cancer who have not     received chemotherapy treatment in the advanced disease setting.   "
186872|NCT00291590|"     Management of chronic diseases, such as diabetes, relies upon the health care providers and     the patients self-care. Self management programs for diabetes that target self-empowerment     tools have been found to be effective in some studies, but have not typically included     individuals on Medicaid.      Our goal for this trial was to observe if patients participating in such a program could     decrease glycated hemoglobin levels, improve health status and improve self-care practices.   "
186873|NCT00291603|"     Background:      The new hollow fibre FX-class of dialysers (Fresenius Medical Care, Bad Homburg, Germany)     features a number of technological improvements that may benefit the patient. This includes     the use of the advanced high-flux polysulfone membrane, Helixone®, which has an extremely     high endotoxin retaining capability. Theoretically leading to reduced systemic inflammation     in the patient, which is an important factor for morbidity and mortality with dialysis.      The dialysis membrane is the first to be manufactured using membrane-spinning procedures     (nano-controlled spinning technology) that enables the membrane to be modulated at the     nano-scale level. The resultant membrane is able to extremely efficiently remove middle     molecules, along with minimal loss of albumin.      These features may lead to improved patient outcomes, including reduced systemic inflammation     and improved quality of life.      Aims:        1. To assess the short-term effects of the FX-class Dialyser on quality of life in stable          haemodialysis patients        2. To assess the short-term effects of the FX-class Dialyser on inflammatory markers in          stable haemodialysis patients.   "
186874|NCT00291616|"     The purpose of this study is to determine the optimal treatment duration of antiviral therapy     for chronic hepatitis B.   "
186875|NCT00291629|"     This trial was performed to evaluate the safety of G-CSF based stem cell therapy and to     compare outcome of intracoronary infusion of mobilized PBSCs between patients with AMI and     OMI.   "
186876|NCT00291642|"     The purpose of the study is to assess the efficacy comparability of cetirizine and     levocetirizine, by comparing the effects of single intake of the two drugs to placebo in     reducing symptoms of SAR in ragweed sensitive adult subjects exposed to ragweed pollen in an     Environmental Exposure Unit.   "
186877|NCT00291655|"     For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from     newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175     (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the     treatment, to receive treatment with levetiracetam until the monotherapy indication for     levetiracetam is granted in Europe.      To continue to assess safety of levetiracetam as per adverse event reporting and observation     of weight changes.   "
186878|NCT00291668|"     This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in     patients with Crohn's disease.   "
186879|NCT00291681|"     Our overall objective in this study is to study the role of B cells in inflammatory bowel     disease (IBD), using a combination of high-throughput experimental and novel bioinformatical     techniques.      Idiopathic IBD includes Crohn's disease (CD) and Ulcerative Colitis (UC), which are chronic     inflammatory disorders of the intestine. IBD is common in developed countries, with up to 1     in 200 of individuals affected by theses diseases. It is currently thought that the disease     arises owing to a complex array of genetic, environmental and immunologic susceptibility     factors. T cells are thought to cause the lesions, but the B cell population apparently has a     significant role as well, through secreting antibodies against certain self-antigens. We     believe that a major contribution to the understanding of the pathogenesis of IBD, and     especially of the immune pathway leading to CD, can be achieved by analysis of the B cell     clones participating in immune responses in the gut, in particular their immunoglobulin (Ig)     variable region gene diversity, which has never before been studied in the context of IBD.      The adaptive immune system is one of the only two biological systems capable of continuously     learning and memorizing its experiences. This is a highly complex, distributed system, in     which pathogen recognition, decision-making and action are performed by an interacting     network of diverse lymphocytes. Immune learning and memory are embedded in the dynamical     states of the complete lymphocyte repertoire, and cannot be understood by studying the     behavior of single cell types. This complexity, further increased by the non-linear behavior     of each component, can only be elucidated by using theoretical tools to complement     experimental and clinical studies. Needless to say, many aspects of the deregulation of     lymphocyte clones are not evident in the phenotype of the single cell but rather in the     population dynamics of a whole clone (or many clones) of cells, as in B cell lymphomas. Such     aspects are best elucidated by studies of the population dynamics and genetics of the     relevant B cell clone(s).      In this study, we propose to utilize a novel bioinformatical approach – the analysis of the     shapes of Ig gene mutational lineage trees. This is the main innovative feature in our     proposal, as it taps into parameters that have never before been measured or analyzed with     respect to B lymphocytes in IBD. While the method is new, it has already been shown that     graphical analysis of B cell lineage trees and mathematical quantification of tree properties     provide novel insights into the mechanisms of normal and malignant B cell clonal evolution. A     preliminary analysis of lineage trees from other autoimmune diseases (shown below) indicates     that, given sufficient amounts of data, the method could elucidate changes in Ig gene     diversification and selection in IBD patients.      Moreover, we aim to search for correlations between the parameters characterizing Ig gene     diversification and parameters characterizing patients, disease history and severity, and     histological markers, as this has the potential of yielding novel diagnostic and prognostic     tools.   "
186880|NCT00291694|"     To assess the effects of twelve months of celecoxib administration by evaluating breast     tissue needle aspirations, to determine if cell growth can be slowed.   "
186881|NCT00291707|"     The purpose of this Phase I study is to determine the safety and effectiveness of two     chemotherapies drugs, Cetuximab and Pemetrexed (Alimta), when given in combination with     radiation therapy.   "
186882|NCT00291720|"     Patients with kidney failure have a poor survival rate that is due to a much higher than     average rate of heart and vascular disease. The reason that kidney failure causes heart     disease is unknown but recent research suggests that a hormone called aldosterone, which is     increased in patients with kidney disease may damage the heart and blood vessels.      The investigators propose, using a randomized blinded trial, to find out whether drugs that     inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in     patients with kidney failure   "
186942|NCT00292513|"     Standard suture is superior to both tissue adhesive (2-octyl cyanoacrylate) and absorbable     sutures with respect to cosmetic outcome of, complication rate of and parental satisfaction     with the closure of low tension facial, neck and shoulder, wounds in children and adolescents   "
186903|NCT00291993|"     Obstructive sleep apnea syndrome is complicated by considerable cardiovascular morbidity and     mortality, at least partly due to hypertension. Nocturnal hypoxia, hypercapnia and acidosis     stimulate chemoreceptors and presumably increased secretion of vasoactive hormones which     might be responsible for hypertension in these patients.      The aim of this study is to measure the secretion of vasoactive hormones at night and to     analyse the relationship between vasoactive hormones, oxygen saturation and the blood     pressure at night.   "
186904|NCT00292006|"     The purpose of this study is to find out whether computerized tomography will be better than     plain radiographs in determining pediatrics scaphoid fractures.   "
186905|NCT00292019|"     This is a pilot study to evaluate the role of RALRP in the management of localized prostate     cancer.   "
186883|NCT00291733|"     Levodopa-induced dyskinesias have been associated with irregular oscillatory discharge     characteristics of basal ganglia. From the other hand, LEV which shares a different     electrophysiologic profile than other antiepileptics, inhibits hyper-synchronization of     abnormal neuronal firing in experimental models of epilepsy. LEV also reduces     levodopa-induced dyskinesias in MPTP-lesioned macaques and modulates priming phenomenon     which associated with long-term changes in synaptic function that can lead to dyskinesias in     PD.      Study objectives :        -  To evaluate the effects of levetiracetam (LEV) in two doses (500 and 1000mg) vs placebo          on disabling dyskinesias that develop as result of long-term treatment with levodopa,          occurring at the time of maximal clinical improvement in patients with Parkinson's          disease (PD).        -  To evaluate the safety of LEV in patients with PD and antiparkinsonian medication.   "
186884|NCT00291746|"     The primary objective of this study is to determine the accuracy of the Reflux Disease     Questionnaire (RDQ) as a diagnostic test for gastroesophageal reflux disease. Symptom     evaluation by the RDQ will be compared with other established approaches to the diagnosis of     gastroesophageal reflux disease (GERD) in a primary care patient population with symptoms     thought to be of upper gastrointestinal (GI) tract origin.   "
186885|NCT00291759|"     The purpose of this study is to assess the difference in event-free survival between     postmenopausal women with hormone receptor-positive early breast cancer who switched from     tamoxifen to anastrozole and those who continued to receive tamoxifen.   "
186886|NCT00291772|"     The purpose of this study is to see if giving the study drug in a slow and steady dose will     lower blood sugars during the meal and after-meal time.   "
186887|NCT00291785|"     CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors     designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to     normal tissues. The objective of this study is to determine the dose limiting toxicities,     safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for     the treatment of colorectal cancer.   "
186888|NCT00291798|"     The objective of the present clinical investigation is to determine whether hormonal therapy     given preoperatively is able to reduce tumor size to an extent that facilitates     breast-conserving procedures.   "
186889|NCT00291811|"     The purpose of this program is to provide access to AMD3100 for patients who would benefit     from an autologous stem cell transplant but who have either previously failed to collect     enough cells for transplant following standard therapy or are not considered by their     physician to have a reasonable chance of collecting enough cells for transplant.   "
186890|NCT00291824|"     The purpose of this trial is to study the effects on risk reduction and expense of 3     approaches to the care of people with cardiovascular risk factors in a naturalistic primary     care environment.   "
186891|NCT00291837|"     The purpose of this sudy is to determine the response rate of CT-2106 in patients with     advanced ovarian cancer who have failed one prior platinum and taxane based regimen.   "
186892|NCT00291850|"     A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose     - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant     chemotherapy in this patient population.   "
186893|NCT00291863|"     This study will analyse the effect of simvastatin on endothelium dependent venodilation in     chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that     patients will have a greater endothelium dependent venodilation after four months of     simvastatin use.   "
186894|NCT00291876|"     The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150,     162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a     2 dose vaccination schedule of hepatitis A vaccine.      This protocol posting deals with objectives & outcome measures of the extension phase at year     11 to 20.      No additional subjects will be recruited during this long-term follow-up.   "
186895|NCT00291889|"     Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three     doses of primary vaccination followed by a booster dose after completion of primary     vaccination course. Booster vaccination will be given only to subjects receiving the     candidate tuberculosis vaccines and not to the subjects receiving active comparators or     control.   "
186896|NCT00291902|"     Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary     heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).   "
186897|NCT00291915|"     Evaluation of two treatment modalities in early potentially severe early arthritis (     Methotrexate alone or in combination with adalimumab)   "
186898|NCT00291928|"     The purpose of this trial is primarily to investigate the safety profile of HuMax-CD20 in     patients with active RA. Furthermore, the trial is designed to identify the dose levels to be     used in future trials (based on evaluations of safety, pharmacokinetics and ACR and DAS     responses).   "
186899|NCT00291941|"     The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an     improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral     immune responses after the primary vaccination course.   "
186900|NCT00291954|"     Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg     surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a     benefit for this population.   "
187503|NCT00300846|"     The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy     of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who     are not optimally controlled on clozapine.   "
186901|NCT00291967|"     To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with     that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals’ Hiberix™     vaccine and Tritanrix™-HepB vaccine mixed with Hiberix™ vaccine and concomitantly     administered with Wyeth Lederle’s meningococcal C conjugate vaccine (Meningitec™), with     respect to antibody response to vaccine antigens (meningococcal serogroups A and C and PRP)     after a three-dose primary vaccination course.   "
186902|NCT00291980|"     The immune response of uraemic patients to hepatitis B vaccination is impaired compared to     healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As     the persistence of anti-HBs is closely related to the initial anti-HBs peak, a more     immunogenic vaccine, allowing higher antibody concentrations, would be a benefit for this     population.   "
187721|NCT00304902|"     The purpose of this study is to review medical records at MEDVAMC in order to relate the     outcome of bacteremic MRSA infection to the antibiotics selected for treatment.   "
186912|NCT00292110|"     Background:      - The treatment of addiction often hinges on preventing relapse into drug-using behaviors,     which occurs at high rates even after prolonged abstinence. Some methadone patients continue     to abuse cocaine and heroin during treatment, even with extensive psychosocial services. More     research is needed to look at the results from earlier studies of continued drug use during     methadone treatment, focusing on the results of fixed vs. flexible doses of methadone to     reduce the likelihood of continued drug use and the role of monetary vouchers as an incentive     to continue abstinence from illicit substances.      Objectives:      - To determine if the combination of flexible methadone dosing and voucher-based contingency     management can improve rates of abstinence from heroin and cocaine.      Eligibility:      - Individuals between 18 and 65 years of age or older who are dependent on opioids (cocaine     and/or heroin).      Design:        -  The study will last 40 weeks. After the initial screening, participants will receive          daily methadone and weekly drug counseling sessions that will continue throughout the          study.        -  After 6 weeks of methadone treatment, participants who continue to use heroin and          cocaine will be randomized to one of four groups for 16 weeks of study. Each group will          receive a flexible or fixed dose of methadone, and one of two contingency management          conditions.        -  Flexible-dose participants will receive individualized dose increases, based on drug use          and withdrawal. Fixed-dose participants will be set at a specific dose of methadone that          will not be changed.        -  The two contingency management conditions will be monetary vouchers given for regular          cocaine-negative urine samples, or vouchers independent of urine cocaine screen results.        -  After the study phase, participants will have 10 weeks of standard individual counseling          and stable doses of methadone. Urine samples will continue to be collected, but no          vouchers will be given.        -  At the end of the study, participants will have the choice of transferring to a          community clinic or undergoing a 10-week taper from methadone.   "
186913|NCT00292123|"     The primary goal of this study is to determine how contingency management can best be     combined with standard or high doses of methadone to increase simultaneous abstinence from     heroin and cocaine.   "
186914|NCT00292136|"     Background:        -  The treatment of addiction often hinges on preventing relapse into drug-using behaviors,          which occurs at high rates even after prolonged abstinence. Research has shown that          constant reporting through personal data-collection devices, such as electronic diaries,          can help prevent relapse and reinforce abstinence. This constant reporting is known as          Ecological Momentary Assessment (EMA).        -  The researchers here at NIDA have already completed two major arms of the study,          focusing on patterns of craving and drug use during methadone maintenance, and on          whether electronic diaries could help remind outpatients to complete treatment tasks. An          ongoing arm of the study is examining connections among drug craving/use, stress, and          geographical location.      Objective:      - To investigate the role of stress associated with geographical location in drug craving and     use.      Eligibility:      - Individuals between 18 and 65 years of age or older who are dependent on opioids (cocaine     and/or heroin).      Design:        -  The study will last 28 weeks. After the initial screening, participants will receive          daily methadone and weekly drug counseling sessions that will continue throughout the          study.        -  After 3 weeks of methadone treatment, participants will have 15 weeks of EMA in which          they will record both event-triggered cravings and daily responses (3 per day). EMA will          consist of event-triggered recordings (initiated by participants whenever they use          heroin or cocaine, or whenever they feel an urge to do so) and random-signal-triggered          recordings (3 per day). During EMA, participants will begin a voucher-based program to          encourage abstinence from heroin and cocaine.        -  Participants will also carry global positioning system (GPS) units to record their          locations during these 15 weeks, and will complete questionnaires about stress levels at          specific intervals during the study.        -  At the end of the study, participants will have the choice of transferring to a          community clinic or undergoing an 8-week taper from methadone.   "
186915|NCT00292162|"     Heart failure is a condition that occurs when the heart muscle weakens and no longer     contracts normally. Half of these patients have an irregularity of heart rhythm called atrial     fibrillation (AF). Patients with both heart failure and AF spend more time in hospital, and     die earlier than those with heart failure alone. AF is difficult to treat with conventional     methods in patients with heart failure. Radiofrequency ablation is a new technique used to     cure AF. The investigators aim to establish if radiofrequency ablation for atrial     fibrillation in patients with advanced heart failure can result in marked improvement in the     function of the heart.   "
186916|NCT00292175|"     The purpose of the study is to determine whether a new colonoscopic viewing technique called     narrow band imaging (NBI) helps doctors detect more patients with at leat one pre-cancerous     area (dysplasia associated lession or mass, MALMs) than conventional colonoscopy using white     light alone.   "
186917|NCT00292188|"     To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic     peripheral neuropathic pain   "
186918|NCT00292201|"     Asthma is a chronic respiratory condition characterized by bronchial hyper-responsiveness     secondary to abnormal inflammation of the lung. Steroids remain the most effective treatment     for this condition. The lipid lowering agents statins have been found to have     anti-inflammatory properties. This study is to test the hypothesize that statins will     decrease bronchial hyperresponsiveness and inflammation, leading to improved symptoms in     patients with asthma.   "
186919|NCT00292214|"     To determine the amount of paracetamol in the blood when given in either intravenous or oral     forms prior to cholecystectomy. The clinical effectiveness of each form will also be     evaluated with pain scores and the use of other pain relief drugs.   "
186920|NCT00292227|"     The purpose of this trial is to assess whether rotigotine has an effect on the electrical     activity of the heart. Moxifloxacin infusion is used as positive control to assess assay     sensitivity.   "
186940|NCT00292487|"     The purpose of the study is to compare the incidence of contrast induced nephrotoxicity     following the administration of Isovue or Visipaque in patients with mild to moderate renal     impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed     tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine     (SCr) will be measured before and up to 48-72 hours post dose.   "
186941|NCT00292500|"     This evaluation is designed to evaluate the feasibility of using an automated distal coronary     anastomotic to facilitate grafting of the left internal mammary artery to the left anterio     descending coronary artery during myocardial revascularization in patients with coronary     artery disease requiring surgical intervention. The study is designed to assess the ability     to compare the patency of grafts created using an automated device versus hand-sewn grafts of     the same vessels in the same patient population.   "
186921|NCT00292240|"     Over the past decade, many new programs intended to prevent substance use among adolescents     have been developed and evaluated. There has been a recent shift towards brief interventions     for youth in school (Brown, 2001; D'Amico and Fromme, 2002) and health care settings, such as     emergency rooms and inpatient clinics (Barnett et al., 2001; Colby et al., 1998; Monti et     al., 1999). Although the primary care setting presents a unique opportunity to intervene with     youth concerning drug use, such as marijuana or inhalants, many youth are not screened for     use (Friedman et al., 1990; Johnson and Millstein, 2003; Middleman et al., 1995) and     preventive services in this setting are significantly below recommended levels     (Halpern-Felsher et al., 2000; Klein et al., 2001; Ozer et al., 2001). The objectives of the     proposed research are to: 1) explore the feasibility of adapting a brief intervention from     our previous work for use in the primary care (PC) setting, and 2) assess the short-term     efficacy of the intervention in the PC setting. During year 1, focus groups of high-risk     youth (n=16), parents (n=8), and providers (n=8) will provide feedback on barriers to     implementing a substance use brief intervention in a PC setting. We define high-risk youth as     those who may have already developed regular patterns of use or have experienced some     problems due to their use. In addition, the intervention will be pilot tested with 10     high-risk youth who will provide feedback on intervention content. Revisions will be made to     the intervention curriculum based on this feedback and in year 2, the short-term efficacy of     the intervention will be tested with a small sample of high-risk youth (n=30). This study     will extend brief intervention research for youth, as it will be one of the first to examine     the feasibility of implementing a brief substance use intervention to PC with high-risk youth     and to determine the impact of this intervention on short-term outcomes.   "
186922|NCT00292253|"     This is a randomized, multicenter, parallel-group, open-label study comparing the     tolerability of Rebif® injections (44 microgram [mcg] administered subcutaneously three times     a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting     multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two     Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a     minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to     assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3     months after the initiation of treatment.   "
187347|NCT00289588|"     The main purpose of this study is to determine if applying mupirocin into soldiers noses who     are colonized with methicillin-resistant Staphylococcus aureus (MRSA) will reduce infections     in them and their cohort of fellow soldiers.   "
186923|NCT00292266|"     This is an open-label, randomized, multicenter, comparative, and parallel-group study     comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting     multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44     microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of     Avonex® 30 mcg intramuscular injection given once a week.   "
186924|NCT00292279|"     The purpose of this study is to evaluate clinical safety and effect of Omega-3 fat oil     emulsion on outcome in post-operative cancer patients.   "
186925|NCT00292292|"     The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single     level degenerative disc disease at L4/5 or L5/S1.   "
186926|NCT00292305|"     This is a study of crush- or culotte stenting of bifurcation lesions using drug eluting     stents. This is a randomized Nordic multicenter study including 400 patients with angina     pectoris with clinical angiographic follow-up.   "
186927|NCT00292318|"     The purpose of this study is to determine if a behavioral treatment method called biofeedback     will reduce the frequency of episodes of leakage of fecal material in patient suffering from     fecal incontinence.   "
186928|NCT00292331|"     The purpose of this study was to test the hypothesis by comparing the efficacy of     cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute GVH in liver     cirrhotic patients with or without concomitant hepatocellular carcinoma (HCC).   "
186929|NCT00292344|"     Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to     antibiotic treatment.The study was designed to determine the value of rapidly acting     loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in     travelers' diarreha treatment.   "
186930|NCT00292357|"     Bone marrow cells were previously shown to enhance wound healing in experimental diabetes. In     this pilot study, patients with chronic diabetic ulcers not healing under conventional     therapy, will be treated with local application of autologous bone marrow cells.   "
186931|NCT00292370|"     The purpose of this study is to compare the response of veterans with PTSD without an optimal     response to paroxetine to quetiapine augmentation versus placebo.   "
186932|NCT00292383|"     The purpose of this study is to determine whether there is a relationship between ventricular     lead position and the incidence of heart failure and atrial fibrillation in patients with     indication for permanent pacemaker stimulation.   "
186933|NCT00292396|"     The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of     moderate to severe chronic plaque psoriasis.   "
186934|NCT00292409|"     The purpose of this clinical research study is to evaluate the overall effectiveness of 8     week of aripiprazole treatment.   "
186935|NCT00292422|"     This Phase 2a study is designed to evaluate the safety and tolerability of multiple     subcutaneous (SC) doses of BG9924, administered in a cohort dose-escalation fashion, in     patients with active rheumatoid arthritis (RA) who have had an inadequate response to therapy     with disease-modifying anti rheumatic drugs (DMARDs) and who may have undergone anti-TNF     therapy. This study will assist with dose selection for further planned Phase 2 studies.   "
186936|NCT00292435|"     To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous     insufficiency linked to edema (swelling) and subjective symptoms   "
186937|NCT00292448|"     The objective of this trial is to compare the efficacy and the safety of Ba 679 BR Respimat 5     ug once daily to tiotropium inhalation capsule 18 ug (Spiriva inhalation capsule) in a     crossover study of 4-week treatment periods in patients with COPD.   "
186938|NCT00292461|"     The purpose of this study is to evaluate the efficacy and safety of zonisamide for     anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial     or partial with secondary generalized seizures.   "
186939|NCT00292474|"     The ultimate goal of a paclitaxel eluting stent system (TAXUS stent) is to prevent restenosis     by blunting the initial response to stent implant injury and sustaining the arrested response     until vascular healing has taken place.      The purpose of the TAXUS IV-SR trial is to study the safety and efficacy of the TAXUS Stent     under controlled trial circumstances used in the treatment of new coronary artery lesions     (heart blockages) This clinical investigation will evaluate the safety and effectiveness of     the TAXUS Stent with 1 ug/mm2 (loaded drug/stent surface area) of paclitaxel incorporated     into a slow rate-release formulation of a triblock copolymer carrier system for treatment of     new coronary artery lesions.   "
186943|NCT00292526|"     In cancer patients, the increase of troponin I soon after chemotherapy is a strong predictor     of left ventricular dysfunction and poor cardiologic outcome. This information provides a     rationale for the development of prophylactic strategies directed against     chemotherapy-induced cardiotoxicity (CTIC). Activation of the renin-angiotensin system has     been proved to be involved in the development and progression of cardiac dysfunction in     several clinical settings, and has been suggested to have a role in the occurrence of CTIC.     We investigated the role of treatment with ACE-inhibitors in the prevention of CTIC in     high-risk cancer patients.   "
187722|NCT00304915|"     This study is a randomized trial designed to test and refine a collaborative care model for     treating depression in VA patients with HIV.   "
186945|NCT00292552|"     This is a 3 year longitudinal study to identify novel endpoints and compare these with     standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to     measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression     over time. Control subjects (smokers and never smokers) will be recruited as comparators with     the COPD subjects.   "
186946|NCT00292578|"     Background: Studies have noted a correlation between food sensitivities and health disorders.     Various commonly seen health problems may be caused by cane sugar since it is lavishly and     frequently used by people worldwide.      Objective: This study evaluated the efficacy of NAET testing instruments in detecting     hypersensitivities to cane sugar.      Materials and Methods: Seventy-four subjects volunteered for this study. They were asked to     write down one of their major health problems, the amount of sugar consumed on a daily basis     and any known health problem(s) related to sugar consumption. The following testing     modalities were used in the study: (1). Allergy Symptom-Rating Scale (ASRS); (2). NST Rating     Scale (NSTRS); (3). Pulse Difference Rating Scale (PDRS). Test-1 was done twice. Tests 2 and     3 were done three times each: once without contacting sugar and then contacting sugar at one     minute and ten minutes.   "
186947|NCT00292591|"     The purpose of this study is to determine the effectiveness of vitamin D supplementation     during pregnancy starting at the beginning of the second trimester. Mothers will be     randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units     per day. It is hypothesized that the highest dosing regimen will result in a better vitamin D     status of women regardless of their ethnicity or race.   "
186948|NCT00292656|"     Background: It has been suspected in our clinic patients that when patients do not wash their     hands after receiving NAET treatments, the effect of their treatments has been reduced or in     some cases, the same treatment has to be repeated more times to be effective.      Location of the study: PNIB Research Center 6714 Beach Blvd. Buena Park, CA 90621      Purpose The purpose of the study was to determine the importance of hand-washing with plain     water after each NAET® treatment. The study utilized an experimental design with random     assignment to two groups, consisting of treatment/experimental, and treatment/control groups.      Objective: We sought to determine if there is any benefit to mandate hand-washing with plain     water after each NAET® treatment.   "
186949|NCT00292695|"     To determine whether adding combinational chemotherapy concurrently to conventional radiation     will improve the response rate, event-free survival, and overall survival.      To test the dose intensity and toxicity of chemotherapy in concurrence with radiation.      To detect the blood EBV DNA level in Chinese Nasal NK/T-cell lymphoma patients and correlate     to the treatment response and prognosis.   "
186950|NCT00292708|"     To determine the optimal prophylactic antibiotics administration method in elective     colorectal surgery   "
186951|NCT00292721|"     Several studies including ours have reported that celecoxib improves endothelium-dependent     vasodilation and reduces inflammation and neointimal hyperplasia. Our hypothesis is that     celecoxib may reduce the late luminal loss after coronary stent implantation     (paclitaxel-eluting stent.   "
186952|NCT00292734|"     Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more     effective in the treatment of the secondary insomnia of depressive and dysthimic patients     than antidepressant therapy alone in the acute phase of the disease.   "
186953|NCT00292747|"     The aim of the study is to show that the combination of drotaverine 80mg and ibuprofen 400 mg     is more effective and as well-tolerated as ibuprofen 400 mg or drotaverine 80 mg administered     alone, in the treatment of primary and secondary dysmenorrhoea.   "
186954|NCT00292760|"     This is a phase II open label study for patients with p53-deleted CLL who require treatment.     Both untreated and previously treated patients are eligible for study entry.      The trial consists of giving continuous alemtuzumab and cyclical high-dose     methyl-prednisone.Alentuzumab is given intravenously during the first 4 weeks of treatment to     ensure that adequate serum levels are achieved quickly. The drug will be administered daily     during the first week, commencing at a dose of 3mg, and increasing to 10mg and then up to the     target dose of 30mg as tolerated.Thereafter alemtuzumab will be given at a dose 30mg thrice     weekly. From week 5, alemtuzumab will be given at the same dose but by the subcutaneous route     of administration.      Methlyprednisolone will be given for 5 consecutive days at a daily dose of 1.0g/m2, starting     on Day 1 and repeating the cycle every 28 days.      Treatment will be given for 16 weeks (i.e 4 cycles of methylprednisolone). Treatment will be     discontinued if there is no response after 8 weeks, or if toxicity becomes unacceptable.   "
186955|NCT00292773|"     This study will investigate the role of weight reduction surgery on the reproductive     performance of obese women with ovulation problems. It is hypothesized that surgery offered     when other methods of weight reduction have failed, may help restore ovulation.   "
186956|NCT00292786|"     This proposal is designed to achieve the following specific aims and will test the associated     hypotheses:      AIM 1: To compare walking ability, standing posture, gait initiation and functional standing     and stepping of twenty children with typical development to that of twenty children with     spastic diplegia or hemiplegia, CP.      Hypotheses        -  Children with CP will demonstrate impaired coordination as compared to children of          typical development. In addition, children with CP will demonstrate inappropriate foot          contact area, decreased velocity and step length as compared to children of typical          development.        -  Children with CP will demonstrate impaired postural control as compared to children of          typical development.        -  Children with CP will demonstrate an impaired gait initiation motor program as compared          to children with typical development.        -  Children with CP will take more time to complete the timed up and go test and          demonstrate decreased reaching distances in the functional reach test as compared to          children of typical development.      AIM 2: Using a single-blinded, randomized, controlled study design, to assess the ability of     a 12-week at-home electrical stimulation gait training program to improve walking ability,     standing posture, gait initiation, functional standing and stepping, and satisfaction with     walking ability for a group of 10 children with spastic diplegia or hemiplegia CP as compared     to a group of 10 children with spastic diplegia or hemiplegia CP who undergo a 12-week     at-home gait training program without electrical stimulation.      Hypotheses        -  The ES gait training group will demonstrate improved joint coordination as compared to          the group undergoing a gait training program without ES. The ES gait training group will          demonstrate improved foot contact area, increased self-selected walking velocity and          greater step length as compared to the group undergoing a gait training program without          ES.        -  The ES gait training group will demonstrate improved postural control as compared to the          group undergoing a gait training program without ES.        -  The ES gait training group will demonstrate improved gait initiation as compared to the          gait training group without ES.        -  The ES gait training group will demonstrate decreased times on the Timed Up and Go and          an increase in functional reach as compared to the group undergoing a gait training          program without ES.        -  The ES gait training group will demonstrate greater satisfaction and self-perceived          performance on everyday tasks related to walking function and posture as measured by the          COPM compared to the group that undergoes a gait training program without ES.   "
186957|NCT00292799|"     This study aims to investigate the role of the weight reduction agent, Orlistat compared to     the Metformin for the management of women who are obese and do not ovulate or have difficulty     conceiving. Patients will receive either one of these medications and will be monitored at     regular intervals with hormone blood tests and ultrasound scans in order to study the effect     of the medications on the reproductive functions. Patients will receive the medications for     three months and the study will end if the patient becomes pregnant. The study also aims to     investigate the dose of metformin that should be used as there is no consensus to date     regarding the optimum dosage for this drug   "
186959|NCT00292825|"     The main purpose is to prevent syncope in patients with recurrent syncopal episodes caused by     malignant vasovagal faints and bradycardia. Patients are treated by a special pacemaker     (closed loop stimulation [CLS]) which can potentially identify an incipient attack and     prevent syncope by pacing.   "
186960|NCT00292838|"     To investigate the validity of a clinical model to determine the relative potency of     different preparations of inhaled corticosteroids used for the treatment of asthma or of     eosinophilic bronchitis without asthma.   "
186961|NCT00292851|"     To process blown nasal secretions from subjects with rhinosinusitis and to obtain a specimen     by nasal lavage. To investigate the reliability and validity of the measurements we will     determine their repeatability and compare them with those of nasal lavage in the same     subjects.   "
186962|NCT00292864|"     The purpose of this study is to assess the safety and tolerability of one-hour infusions     given once daily for 5 consecutive days in a 21-day treatment cycle; to define a recommended     phase 2 dose; and to learn more about the clinical activity of SNS-032.   "
186963|NCT00292877|"     The purpose of this study is to determine if treatment with anti-IL-5 antibody has a     prednisone-sparing effect in patients with symptomatic eosinophilic bronchitis (with or     without asthma).   "
186964|NCT00292890|"     Background and aims:        -  In the Netherlands most patients with diabetes mellitus that are treated with insulin,          use an insulin pen for insulin administration. The injection technique can influence the          absorption rate of insulin.        -  The aim of this study is to compare the effect of insulin injections using a 5 mm          insulin needle with insulin injections using a longer needle, on HbA1c, bloodglucose          levels, hypoglycaemic events, bleeding, bruising, insulin leakage and pain perception.        -  Study Hypothesis: 'Insulin injected with needles of 5 mm can be given without a          skinfold. The length of the needle will not influence HbA1c levels and bloodglucose          levels’.   "
186965|NCT00292903|"     This study will compare the effectiveness of brief interpersonal psychotherapy versus     standard treatment for pregnant women with depression.   "
186966|NCT00292916|"     The effect of whole body vibration (WBV) on bone strength and fall frequency in older adults     is still vague. Although there is some evidence that WBV may impact Bone Mineral Density in     very frail elderly, there is a lack of data concerning the effect of WBV in community-living     elderly woman. We hypothesize that WBV significantly affects bone parameters as assessed by     DXA, QCT, US and bone markers with parallel positive changes of fall related risk factors     (power, strength, balance, and reaction time). We further hypothesize that the effects of WBV     were superior to conventional resistance exercise.   "
186967|NCT00292929|"     The purpose of this study is to establish the safety, tolerability and pharmacokinetics of a     single dose of the antimalarial drug artesunate.   "
186968|NCT00292942|"     The purpose of this study is to establish the safety, tolerability, and pharmacokinetics of a     multiple dose of the antimalarial drug artesunate.   "
186969|NCT00292955|"     The anti-tumor activity of cetuximab prior to chemoradiotherapy and the safety and     tolerability of cetuximab with concurrent chemoradiation will be determined in women with     locally advanced or metastatic cervical carcinoma.   "
186970|NCT00292968|"     Using an electronic health record to link the resources of primary care practices and     community programs will help patients to improve their diet and exercise, quit smoking, and     moderate their drinking.   "
186971|NCT00292981|"     Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional     C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be     life-threatening and may even result in fatalities, especially in case of involvement of the     larynx.The planned extension study is designed to enrol subjects that participated in the     pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24     months or until the licensing procedure for C1-INH is finalized, whatever comes first.   "
186972|NCT00292994|"     The Metabolic Syndrome (MS) is prevalent in the American population and is strongly     associated with premature coronary disease. Lifestyle intervention, primarily exercise and     dietary changes, are foundational treatment strategies for independent components of MS, but     these interventions have not been thoroughly evaluated in MS. Even with very modest weight     loss, in the setting of caloric restriction and exercise, marked improvement MS parameters     have been noted. However, it is not known whether it is diet with weight loss or exercise     that improves the metabolic derangements associated with MS. We propose a study designed to     examine the relative impact of diet or exercise on the components of MS. Furthermore, it is     known that psychological factors significantly impact the ability of patients to initiate and     sustain lifestyle changes. We will monitor certain psychological states to evaluate their     impact on the success of weight loss and sustainability of lifestyle changes throughout this     study. Specific Aims: 1.) Evaluate the relative efficacy of diet with weight loss or exercise     on improving the markers of metabolic syndrome. 2.) Determine of pre-existing psychological     factors influence the effectiveness of diet with weight loss or exercise on the markers of     metabolic syndrome. Design: Adult women (> 18 yrs) with a body-mass index (BMI)  30 kg/m2     will be assessed for MS and randomized to one of three groups (n = 34/group), Control (C),     diet with weight loss alone (D), or exercise alone (E). The intervention groups will     participate in supervised dietary changes designed for weight loss or exercise for 6 months.     Anthropomorphic, serologic, and psychological parameters will be monitored and compared using     ANOVA. Hypothesis: As indexed by the improvement in the laboratory markers of the components     of metabolic syndrome, exercise alone has a more profound positive impact on Metabolic     Syndrome then diet with weight loss alone.   "
186999|NCT00293371|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor. Giving vatalanib together with     docetaxel and prednisone may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of vatalanib when     given together with docetaxel and prednisone and to see how well they work in treating     patients with advanced prostate cancer.   "
187743|NCT00305201|"     The purpose of this study is to determine whether Chilean children with history of Kawasaki     disease have endothelial dysfunction years after the acute phase of the disease, and if this     condition can be modified by treatment with statins.   "
186973|NCT00293020|"     The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the     management of breakthrough pain in cancer subjects on background opioid therapy. The standard     of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with     minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used,     but because of slow and variable oral absorption, the pain control is not the best with these     products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating     breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick     and is administered by continuously swabbing the interior of the subject's mouth until the     product is dissolved (approximately 15 to 30 minutes). The buccal route of administration     avoids the delay and variability associated with oral absorption.      BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive)     fentanyl, an alternative product to OTFC that does not require the subject to continuously     paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is     placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc     readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of     the disc are water soluble, so the entire dosage form dissolves within 30 minutes of     application.   "
186974|NCT00293033|"     The purpose of this study is to evaluate the efficacy of BEMA fentanyl at any dose in the     management of breakthrough pain in cancer subjects on background opioid therapy. The standard     of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with     minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used,     but because of slow and variable oral absorption, the pain control is not the best with these     products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating     breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick     and is administered by continuously swabbing the interior of the subject's mouth until the     product is dissolved (approximately 15 to 30 minutes). The buccal route of administration     avoids the delay and variability associated with oral absorption.      BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive)     fentanyl, an alternative product to OTFC that does not require the subject to continuously     paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is     placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc     readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of     the disc are water soluble, so the entire dosage form dissolves within 30 minutes of     application.   "
186975|NCT00293046|"     This trial is performed to assess whether the Grazax® treatment compliance can be improved by     use of a compliance device (Memozax®).   "
186976|NCT00293059|"     The purpose of this study is to determine whether the study drug is safe and effective in the     treatment of dysfunctional uterine bleeding.   "
186977|NCT00293072|"     Lupus and vasculitis are autoimmune conditions which can be life threatening. In order to     treat these conditions toxic therapies such as cyclophosphamide and steroids are often     required. These standard treatments are associated with significant side effects. Furthermore     a proportion of patient do not respond to these conventional therapies. Newer safer therapies     are being sought. Rituximab is a drug that eliminates B cell from the blood. B cells are one     part of the human immune system that helps prevent infections. Abnormal activity of the     immune system is responsible for autoimmune disease although the exact mechanisms in lupus     and vasculitis are not yet established. Rituximab is liscenced as a treatment for a form of B     cell cancer called non-Hodgkins Lymphoma and has a good safety track record when used in this     context. It has recently been used to treat some autoimmune conditions with positive results.     In this pilot study we wish to assess the effectiveness and safety of rituximab in patients     with lupus and vascultis that are resistant to conventional therpies.   "
186978|NCT00293085|"     The objective of this study is to evaluate efficacy, safety and quality of life adjuvant     docetaxel-cisplatin chemotherapy versus no adjuvant treatment in patients with completely     resected NSCLC Stage I-II.   "
186979|NCT00293098|"     Patients who have iron overload due to chronic blood transfusions and have developed heart     failure or who are at high risk of heart failure because of the high levels of iron in their     hearts, will be treated with deferiprone, an investigational drug, in combination with     deferoxamine (Desferal). Some studies suggest that deferiprone may be better than     deferoxamine in removing iron from the heart and improving heart function, and that using     both drugs together may remove more iron. Participants would make a clinic visit for lab     studies each week, and would continue to take deferiprone for as long as their physician     feels it is useful in their care.   "
186980|NCT00293111|"     An Open Label, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101     (R-Etodolac) in Patients with Relapsed or Refractory Multiple Myeloma (MM)   "
186981|NCT00293124|"     The rationale is to assess the clinical and biological activity of Imatinib and to compare     the data with historic data.      Additionally this study has been designed to gain more experience with the treatment of GIST     in several Central and Eastern European Countries.   "
186982|NCT00293137|"     The principal aim is to investigate the safety and efficacy of rosiglitazone in patients with     chronic systolic heart (Dilated cardiomyopathy). We hypothesize that in patients with heart     failure, rosiglitazone is safe, and can reduce nitric oxide (NO) derived oxidative stress (in     particular, nitrotyrosine) thereby improving endothelial dysfunction, left ventricular     performance, and metabolic parameters.   "
186983|NCT00293150|"     The principle aim is to determine the efficacy of eplerenone in patients with diastolic heart     failure to reverse cardiac remodeling and to improve diastolic function.   "
186984|NCT00293163|"     To assess the likelihood of keloid and scar formation, pigmentation disorders and     hypersensitivity reactions in patients with skin of color undergoing correction of facial     soft tissue contour deficiencies with Hylaform, Hylaform Plus or Captique.   "
186985|NCT00293176|"     To investigate the efficacy and safety of donepezil in individuals with mild cognitive     impairment on measures of cognition, global function and behavior.   "
186986|NCT00293189|"     We are looking after gene-polymorphies in the p2x7-gene in patient with osteoporotic     fractures.   "
203134|NCT00506233|"     Primary Objective:      1. To determine the feasibility of conducting a multi-site longitudinal observational study     of patients with chronic graft-versus-host disease (GVHD).   "
186987|NCT00293202|"     Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid     arthritis. We are examining whether etanercept is effective in improving the nutritional     status of hemodialysis patients as a consequence of its ability to decrease inflammation.     Hemodialysis patients with end stage renal disease have a high mortality rate. In individual     patients, mortality is associated with a low serum albumin concentration, a marker of poor     nutritional status, and with elevated C-reactive protein, a marker of inflammation. Since     efforts to improve nutrition through dietary intake have not been successful, inflammation is     thought to play a key role in determining nutritional status. Recently, it has been shown     that malnutrition, inflammation, and atherosclerosis are closely related in patients with     chronic renal failure. It is our hypothesis that suppression of the cycle of inflammation,     malnutrition, and vascular injury caused by atherosclerosis will improve survival in dialysis     patients. This study is designed to examine whether suppression of the inflammatory response     can be accomplished safely with etanercept and to determine if this suppression will improve     nutritional status and clinical outcome in hemodialysis patients with poor nutritional status     and evidence of inflammation.   "
187082|NCT00294268|"     The purpose of this study is to evaluate the effectiveness of a cognitive behavioural     treatment (CBT) designed to help obese patients lose weight and to maintain their weight     losses over time. It is hypothesized that CBT will result in greater sustained weight loss.   "
186988|NCT00293215|"     This is a clinical trial of a drug called CMD-193 which is a humanised monoclonal antibody     linked to a toxin (calicheamicin). The purpose of this study is to determine in patients with     advanced tumours expressing the Lewis-Y antigen:        -  How much and how long 111-In-CMD-193 (CMD-193 tagged with a small amount of radioactive          Indium – also called Indium-111 or 111In) circulates in the blood, where the antibody          goes in the body, and how much attaches to the tumour.        -  Whether CMD-193 causes changes in the metabolism (activity) of the tumour.        -  Whether CMD-193 causes shrinkage of the tumour.   "
186989|NCT00293228|"     The purpose of this study is to study the effect that treatment of dormant tuberculosis     infection has on the immunological system.      We expect to observe an impact over the production of cytokines by peripheral white blood     cells which may be useful to know if treatment has been effective.   "
186990|NCT00293241|"     The purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable     cardioverter defibrillator (ICD) patients with a history of right ventricular pacing.   "
186991|NCT00293254|"     This study will investigate the safety and efficacy of raltegravir as a therapy for Human     Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral     resistance.   "
186992|NCT00293267|"     This study will investigate the safety and efficacy of raltegravir as a therapy for     HIV-infected patients failing current therapy with 3-class antiviral resistance.   "
186993|NCT00293280|"     RATIONALE: Drugs used in chemotherapy, such as lomustine, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well lomustine works in treating patients with     stage III or stage IV non-small cell lung cancer.   "
186994|NCT00293293|"     RATIONALE: Chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who     are undergoing chemotherapy.      PURPOSE: This randomized clinical trial is studying how well giving hypnosis, massage therapy     and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed     epithelial ovarian, fallopian tube or peritoneal cavity cancer.   "
186995|NCT00293319|"     RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells     and not harm normal cells.      PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating patients with     refractory or relapsed neuroblastoma.   "
186996|NCT00293332|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Giving docetaxel and carboplatin     together with bevacizumab before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together     with bevacizumab works in treating patients with stage I, stage II, or stage III non-small     cell lung cancer that can be removed by surgery.   "
186997|NCT00293345|"     This phase I trial is studying the best dose of 3-AP and the side effects of giving 3-AP     together with gemcitabine in treating patients with advanced solid tumors or lymphoma. Drugs     used in chemotherapy, such as 3-AP and gemcitabine (GEM), work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. 3-AP     may help gemcitabine kill more cancer cells by making the cells more sensitive to the drug.     3-AP may also stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth.   "
186998|NCT00293358|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, ifosfamide, and     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may     kill more tumor cells.      PURPOSE: This phase III trial is studying combination chemotherapy followed by radiation     therapy to see how well it works compared to radiation therapy alone in treating patients     with germ cell tumors in the brain.   "
187000|NCT00293384|"     RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help     lessen or prevent nausea and vomiting in patients treated with chemotherapy.      PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron     and dexamethasone works in preventing nausea and vomiting in patients receiving     cyclophosphamide before undergoing an autologous stem cell transplant.   "
203135|NCT00506246|"     The purpose of the study to compare Propofol-MCT/LCT with LCT in terms of their efficacy and     safety during total intravenous anaesthesia   "
187001|NCT00293397|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop     the growth of tumor cells, either by killing the cells or stopping them from dividing.     Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping     chemotherapy drugs near the tumor.      PURPOSE: This clinical trial is studying how well chemoembolization using doxorubicin works     in treating patients with liver cancer that cannot be removed by surgery.   "
187002|NCT00293410|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine and     cyclophosphamide in treating patients with relapsed or refractory acute leukemia, chronic     myelogenous leukemia, or myeloproliferative disorders.   "
187003|NCT00293423|"     RATIONALE: Vaccines made from a person's tumor cells, such as gp96 heat shock protein-peptide     complex, may help the body build an effective immune response to kill tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of gp96 heat shock     protein-peptide complex vaccine and to see how well it works in treating patients with     recurrent or progressive high-grade glioma.   "
187004|NCT00293436|"     RATIONALE: Celecoxib and erlotinib may stop the growth of tumor cells by blocking some of the     enzymes needed for their growth. Celecoxib may also stop the growth of liver cancer by     blocking blood flow to the tumor.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving celecoxib     together with erlotinib and to see how well they work in treating patients with liver cancer.   "
187005|NCT00293462|"     RATIONALE: GM-CSF may protect normal cells from the side effects, such as mucositis, of     radiation therapy and may help damaged tissue heal faster after radiation therapy.      PURPOSE: This randomized clinical trial is studying how well GM-CSF works in preventing and     treating mucositis in patients who are undergoing radiation therapy for head and neck cancer.   "
187006|NCT00293475|"     This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and     carboplatin and to see how well they work in treating patients with primary central nervous     system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier     disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing     substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may     block cancer growth in different ways by targeting certain cells. Giving methotrexate,     mannitol, rituximab, and carboplatin together may be an effective treatment for primary     central nervous system lymphoma.   "
187007|NCT00293488|"     RATIONALE: Drugs used in chemotherapy, such as SL-11047, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I trial is studying the side effects and best dose of SL-11047 in     treating patients with relapsed or refractory lymphoma.   "
187008|NCT00293501|"     RATIONALE: Tinzaparin may stop the growth of kidney cancer by blocking blood flow to the     tumor.      PURPOSE: This phase I/II trial is studying the side effects of tinzaparin and to see how well     it works in treating patients with metastatic kidney cancer that cannot be removed by     surgery.   "
187009|NCT00293514|"     The purpose of this study is to compare the sealing efficacy and safety of TachoSil®     (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary     management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung     malignancies with or without metastases.   "
187010|NCT00293527|"     This study will determine the response rate of daily low dose interferon-alpha-2b in patients     with metastatic or unresectable clear cell renal cell carcinoma.   "
187011|NCT00293540|"     This study will determine if hormone receptor positive premenopausal metastatic breast cancer     patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a     longer survival.   "
187012|NCT00293553|"     Total proctocolectomy and ileal pouch-anal anastomosis is the surgical treatment of choice     for patients with medically refractory ulcerative colitis, ulcerative colitis with dysplasia     or cancer, and patients with familial adenomatous polyposis. Pouchitis, an inflammatory     process of the ileal pouch, is the most common long-term complication. Increased stool     frequency, abdominal pain, and pelvic discomfort are suggestive of pouchitis, approximately     40% of patients with these symptoms have no or minimal inflammation of the pouch or rectal     cuff on endoscopy and histopathology. These patients have a condition resembling irritable     bowel syndrome (IBS), which we termed the irritable pouch syndrome (IPS). The RATIONALE and     FEASIBILITY for the proposed study are: 1) IPS occurs in a substantial number of patients     with IPAA, significantly affecting the quality of life. However, IPS is rare in the general     population, and is considered an orphan disease. Studies such as those we propose can only be     conducted in centers with a large number of patients with IPAA. The Cleveland Clinic has     maintained the world's largest ileal pouch registry, with a total of more the 2,500 patients;     2) a series of investigations on the diagnosis and treatment of patients with inflammatory or     functional diseases of IPS, notably the initial study of IPS, have been conducted by our     team; 3) In contrast to IBS, the pathophysiology and treatment of IPS have not been studied.     Our HYPOTHESES are that 1) similar to IBS, visceral hypersensitivity may play a role in the     pathogenesis of IPS, and 2) amitriptyline, a safe and effective agent for patients with IBS,     will be more effective than placebo in alleviating symptoms and improving quality of life in     patients with IPS. The AIMS of the study are to 1) investigate visceral hypersensitivity     using barostat examination of the pouch; 2) conduct a randomized, placebo-controlled clinical     trial evaluating the use of amitriptyline in IPS.   "
187013|NCT00293579|"     This study will estimate overall response rate of pemetrexed in poor risk patients with     advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.   "
187014|NCT00293592|"     This is a multicenter, randomized, double-blind trial, comparing clinical outcomes after the     administration of high-dose dexamethasone versus placebo in patients undergoing heart surgery     with the use of cardiopulmonary bypass. The primary endpoint is the occurrence of major     complications (including all-cause mortality, myocardial infarction, stroke, renal failure,     and prolonged mechanical ventilation) in the first 30 days after surgery.   "
187015|NCT00293605|"     Total hip replacement is a common procedure for the treatment of osteoarthrosis of the hips,     the aims of this study are to determine the effect of implant stem design on bone quality     surrounding the implant using three stem designs that are routinely implanted at this     hospital.   "
187016|NCT00293618|"     This study evaluates whether the implementation of a prediction rule for postoperative nausea     and vomiting changes physician behaviour, improves patient outcome and improves     cost-effectiveness of treatment of postoperative nausea and vomiting.   "
187017|NCT00293631|"     To determine whether a single dose of intravenous lornoxicam is superior to intravenous     placebo for management of post-operative pain in patients who have surgical removal of a     bunion on the lower extremity. One-fourth of patients in this study will receive a single     dose of intravenous ketorolac for management of pain and one-fourth of patients in this study     will receive a single dose of an intravenous placebo.   "
187018|NCT00293644|"     The purpose of this study is to determine whether pre-emptive use of a delayed release     combination of pyridoxine hydrochloride and doxylamine succinate (Diclectin®), before     eruption of symptoms of Nausea and vomiting of pregnancy and hyperemesis gravidarum, will     reduce the incidence of severe forms of this syndrome/HG.   "
187381|NCT00290043|"     To investigate in type 1 diabetic patients the glucodynamic response to HMR1964 insulin and     RHI (HOE31HPR100) injected subcutaneously before and after a standard meal   "
187019|NCT00293657|"     To determine whether a single dose of intravenous lornoxicam is superior to intravenous     placebo for the acute treatment of moderate or severe headache associated with a single     migraine attack in patients with a history of migraine. Two-thirds of patients in this study     will receive a single dose of intravenous lornoxicam (8mg or 16 mg) and one-third of patients     will receive a single dose of an intravenous placebo.   "
187020|NCT00293670|"     To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen     deprivation (LHRHa treatment or orchidectomy)   "
187021|NCT00293683|"     We hypothesize that the use of absorbable staples to close cesarean skin incisions will cause     less pain, have better long-term cosmetic results, and result in improved patient     satisfaction over standard metal staples. We expect to see no difference in wound     complication rates with these two cesarean skin closure techniques.   "
187022|NCT00279942|"     Fibromyalgia is characterized by widespread pain that can lead to significant patient     dysfunction and economic burden to society. The management of patients with fibromyalgia is     difficult and no single treatment modality has been successful. We propose to study the     effect of dietary soy supplement on quality of life associated with fibromyalgia.   "
187023|NCT00279955|"     The purpose of this study is to determine the value of diagnostic data obtained from     Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization     therapy (CRT) to evaluate cardiovascular and heart failure related adverse events and health     care utilization.   "
187024|NCT00279968|"     The purpose of the Registry is to collect data on how Implantable Cardioverter Defibrillator     (ICD) therapies and medications are being used by physicians to treat ventricular arrhythmias     in order to better understand how to improve the clinical care of patients and effectiveness     of ICD therapies.   "
187025|NCT00279981|"     The purpose of this study is to look at the heart rate and rhythm information collected daily     in Medtronic implantable pulse generators (IPG), implantable cardioverter defibrillators     (ICD) and cardiac resynchronization therapy (CRT) devices. The study will gather this     information from many patients to see if heart rate or rhythm data can predict the risk of a     patient having a medical condition such as stroke.   "
187026|NCT00279994|"     The purpose of this study is to determine if supervised exercise therapy in a     physiotherapeutic setting, with or without therapy feedback, is more (cost-)effective than     exercise therapy based on a 'go home and walk' advice without supervision, for patients with     PAD stage II (Fontaine).   "
187027|NCT00280007|"     Patients with liver cirrhosis and hepatocellular carcinoma will undergo transarterial     chemoembolisation (TACE) as clinically indicated and will be randomized to receive     bevacizumab or placebo every 2 weeks up to 1 year. Tumor response will be assessed using MR     of the liver and PET-scanning.      It will be tested whether the addition of bevacizumab as angiogenic inhibitor will slow down     tumor progression, reduce the need for re-embolisation and will improve patient survival.   "
187028|NCT00280020|"     The purpose of this study is to evaluate whether Tai Chi Chih vs. cognitive behavioral     therapy vs. sleep education reduces insomnia in older adults. The secondary goal of the study     is to determine whether the behavioral treatment of insomnia alters proinflammatory cytokine     activity.   "
187029|NCT00280033|"     This study is will gather critical information on the safety, tolerability, and the     immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine     in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Each subject     will participate for about 7 months and will be randomly placed in one of several different     study groups receiving a different dose of vaccine or placebo. All subjects will receive two     injections of their assigned study product, about 28 days apart, in the muscle. Subjects will     keep a journal of their temperature and any adverse effects between study visits. A small     amount of blood will also be drawn before the first injection, 7 days after each injection, 1     month after the first injection, and 1 and 6 months after the second injection.   "
187030|NCT00280046|"     This trial was conducted in Russian Federation. This trial aimed for a comparison of the     effect on glycemic control in subjects with type 2 diabetes of three different treatment     regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in     combination with metformin and treatment with oral anti-diabetic drugs.   "
187031|NCT00280059|"     The purpose of this study is to assess whether Lyrica is a safe and effective treatment for     partial epilepsy in comparison with an established treatment, Lamictal.   "
187032|NCT00280072|"     -  The purpose of this study is to evaluate the safety and efficacy of the RAD to determine          whether the RAD is effective in reducing mortality in patients with Acute Renal Failure          due to Acute Tubule Necrosis and to evaluate the safety of the RAD        -  If the RAD works normally when used for as long as 72 hours        -  If the RAD will provide added benefits to normal CVVH therapy for patients with Acute          Renal Failure   "
187033|NCT00280085|"     Assess pancreatic beta cell function using MR imaging.   "
187034|NCT00280098|"     Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone     refractory prostate cancer under the conditions of daily practise.   "
187057|NCT00293735|"     Eclampsia is a major cause of perinatal morbidity and mortality. The pathophysiology is not     known but magnetic resonance imaging (MRI) and Doppler data suggest that overperfusion of the     cerebral tissues is a major etiologic factor. Hypertensive encephalopathy from overperfusion,     and vascular damage from excessive arterial pressure (cerebral barotrauma) are believed to     lead to vasogenic and cytotoxic cerebral edema, with resultant neuronal anomalies, seizure     activity and cerebral bleeding if left unchecked. Doppler data have shown that cerebral     perfusion pressure (CPP) is abnormally increased in severe preeclampsia and that     autoregulation of the middle cerebral artery is affected by this condition leading to     increased CPP. Magnesium sulfate (MgSO4) is the most widely accepted eclampsia treatment and     prophylactic agent, and it has been used in the USA since the 1950's. Despite widespread use,     its mechanism of action is unknown. MgSO4 is given intravenously or intramuscularly and     requires specialized nursing training and monitoring to minimize toxicity from respiratory     and cardiac depression. Labetalol, a combined alpha and beta blocker, has been used for many     years to safely treat hypertension in preeclamptic women, and is now known to reduce CPP in     women with preeclampsia. In the United Kingdom labetalol was for many years used as the sole     agent in treating preeclampsia, and the rate of seizure was no different to that reported in     the USA with MgSO4. Since labetalol can be administered orally, is economical, has low     toxicity potential, does not require specialized training to administer or monitor, and     decreases CPP, it may be an ideal agent for controlling blood pressure (BP) and decreasing     the incidence of eclampsia in women with preeclampsia. The current study is a multicenter,     randomized, controlled trial to compare the anti-seizure effect of parenteral MgSO4 versus     oral labetalol in hypertensive pregnant women who are eligible for MgSO4 therapy. The primary     outcome measure is eclampsia, and the secondary outcome measures include blood pressure     control, and relevant antenatal, intrapartum, and postnatal maternal and fetal/neonatal     parameters including adverse effects and complications. Inclusion criteria are deliberately     broad in order to make the study clinically relevant. Hypertensive pregnant women, in whom     the decision for delivery has been made, will be enrolled after written, informed consent.     Patients will be randomized to receive MgSO4 therapy as given in their institution, versus     oral labetalol (200mg/q6 hours), from enrollment in the study until 24 hours post delivery.     There will be 4000 patients in each arm of the study and analysis will be by     intention-to-treat. The study is powered to show both therapeutic superiority as well as     clinical equivalence. This study has the potential to change the way preeclampsia is managed,     and will represent a major advance in terms of the availability and safety of prophylactic     therapy, especially in developing nations where MgSO4 is underutilized due to cost     constraints.   "
187137|NCT00294996|"     The purpose of the study is to examine the safety and effectiveness of the drug combination     of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet,     as first line treatment for patients with metastatic HER2+ breast cancer.   "
187035|NCT00280111|"     It has been observed that in children who get a severe rotavirus infection, subsequent     infections cause either no symptoms or generally only mild or moderate diarrhea. This     evidence is the basis for developing a vaccine since it suggests that the first infection     immunizes the child against disease upon re-infection.      It was found that neonatal avirulent strains 116E and I321 induce protective immunity and     offer clinical protection for at least one year. Both these strains are well characterized     and the safety studies have been done in animal models. These candidate vaccine strains have     been evaluated for safety and immunogenicity in adults and children (2 to 12 years of age) by     a randomized double blind placebo controlled trial in Cincinnati, USA. In India, the     diversity of rotavirus strains is greater and there is greater prevalence of malnutrition and     co-infection with other enteric pathogens. These vaccines have therefore, also been tested in     India.   "
187106|NCT00294593|"     The purpose of this study is to determine whether folinic acid can improve developmental     quotient of young Down syndrome patients, given that these present signs of folate deficiency     which are known to cause reversible neurological, psychiatric and cognitive disorders.   "
187036|NCT00280137|"     To examine the psychometric properties of a brief quality of life (QOL) instrument for use in     pediatric systemic lupus erythematosus (SLE). The purpose of this prospective study is     primarily to determine the validity and reliability of a new health-related quality of life     (HRQOL) measure in children with systemic lupus erythematous (SLE). We wish to secondarily     examine concordance between child- and parent-reports of the HRQOL measure and identify     factors associated with poorer HRQOL in them.      Earlier studies have shown that SLE significantly impacts QOL in adults. At present, there is     no disease-specific instrument for measuring HRQOL in children with SLE. In response to these     concerns, we developed the Simple Measure of Impact of Lupus Erythematosus in Youngsters©     (SMILEY©). Establishing the validity and reliability of SMILEY©, examining child-parent     agreement and identifying factors associated with poorer HRQOL will enable us to measure the     impact of SLE in children, and formulate appropriate interventions for this sensitive     population. We plan the following specific aims:        1. to determine construct validity and reliability of SMILEY© child and parent versions in          children with SLE using gold standards (Pediatric Quality of Life inventory - PedsQL          generic and rheumatology modules, Childhood Health Assessment Questionnaire -CHAQ)        2. to determine responsiveness of SMILEY©        3. to examine level of agreement between child- and parent-reports of SMILEY© in children          with SLE        4. to identify medical (steroid use, use of disease modifying agents such as cytoxan,          cellcept, thalidomide, or cyclosporine, disease duration, disease activity and disease          damage etc.) and psychosocial (self-concept, socioeconomic status) factors that affect          HRQOL (as measured by child- and parent-reports of SMILEY© and PedsQL generic and          rheumatology modules) and physical function 5) to translate, adapt and validate SMILEY          in different languages   "
187037|NCT00280150|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy     uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together     with bevacizumab, radiation therapy, and erlotinib may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of bevacizumab and     erlotinib when given together with combination chemotherapy and radiation therapy and to see     how well they work in treating patients with stage III non-small cell lung cancer.   "
187038|NCT00280163|"     This research study is done to find out if genetic make up of a person plays a role in     complications and recovery after the Coronary Artery Bypass Graft (CABG) operation.      As you may be aware, the DNA (Deoxyribonucleic acid) is a chemical in our body that carries     the genetic information. There are common but very small variations (polymorphisms) that     occur in DNA. We would like to find out if these common variations put a person at increased     risk for developing complications- especially rapid irregular heart beat after the CABG     operation.   "
187039|NCT00280176|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as fluorouracil, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving bortezomib and fluorouracil together with radiation     therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     given together with fluorouracil and external-beam radiation therapy in treating patients     with stage II, stage III, or stage IV rectal cancer.   "
187040|NCT00280189|"     The purpose of this study is to assess short and long term outcomes after radiofrequency     ablation (RFA) of pulmonary malignancies in patients who are not candidates for surgical     resection. This study will evaluate the efficacy of RFA for the treatment of lung tumors by     assessing its impact on local tumor control, progression free survival, overall survival,     dyspnea score and quality of life (QOL).   "
187041|NCT00280202|"     The purpose of the intended genetic research is to improve the diagnosis and prognosis of     lung cancer patients as well as to identify genetic risk factors that may predict lung cancer     risk.   "
187042|NCT00285610|"     Prior research indicates a link between early lead exposure and risk for delinquent behavior.     In this study, we follow a large birth cohort from the Cincinnati Lead Study into early     adulthood to determine whether this increased risk persists. Outcome measures include     official arrest records, diagnoses of Substance Abuse Disorder and Antisocial Personality     Disorder, self-report of delinquent behavior, and a psychopathy scale. Predictors include     pre-natal and post-natal blood lead levels. Multivariate statistical methods will control for     potential confounders/covariates.   "
187043|NCT00285623|"     The purpose of this study is to collect information, after exposure to TachoSil ®, of all     thromboembolic events, immunological events and drug interactions leading to thromboembolic     events or major bleeding. In addition, pharmacoeconomic data will be collected.   "
187044|NCT00285636|"     The purpose of the study is to investigate the psychological effects of burn injuries as     experienced by patients.   "
187045|NCT00285649|"     The purpose of this study is to compare the clinical effectiveness of two types of     chiropractic spinal manipulation to conservative medical care for patients at least 55 years     old with sub-acute or chronic LBP.   "
187072|NCT00293930|"     A study to assess the safety and effectiveness of tacrolimus cream in the treatment of     psoriasis   "
187858|NCT00306735|"     The primary purpose of this study is to explore the efficacy of three different dose     schedules of palonosetron for the prevention of emesis over a 7-day study interval in     multiple myeloma patients.   "
187075|NCT00293969|"     RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to     administer intravenous opiates, what is the difference in pain relief at 60 minutes in     patients who are randomized to receive either weight-based IV morphine 0.1mg/kg or     weight-based IV morphine 0.15 mg/kg?      HYPOTHESIS: In adult ED patients who receive IV morphine at a dose of 0.15/mg, more patients     will report moderate to complete pain relief than patients receiving a dose of 0.1 mg/kg.      SIGNIFICANCE: If it is shown that morphine 0.15 mg/kg gives better pain relief to patients     with comparable side effects when compared with morphine at a dose of 0.1 mg/kg, then we may     be able to provide evidence to suggest that the higher dose should be used for adult ED     patients under the age of 66 presenting with acute pain.   "
187076|NCT00293982|"     The purpose of this study is to determine whether physician knowledge of parental pre-visit     expectations improves patient satisfaction in the pediatric emergency department.   "
187077|NCT00293995|"     Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of     contralateral patent processus vaginalis if present, versus open repair   "
187078|NCT00294008|"     This study is a non-interventional web based registry designed to assess demographic,     treatment and outcomes data in patients receiving treatment with long-acting injectable     risperidone. One year retrospective data and 2 year prospective data will be collected.   "
187046|NCT00285662|"     In malaria-endemic areas, young children have an especially high risk of malaria morbidity     and mortality. Malaria is estimated to cause up to 2 million deaths and 500 million clinical     episodes in Africa alone. The bulk of disease in Africa and severe disease and deaths     globally is due to P. falciparum. However, P. vivax is also responsible for a substantial     disease burden in endemic regions outside Africa, where P. vivax may account for more than     half of all malaria cases. Efforts to reduce this unacceptably high disease burden are     hampered by the limited availability of affordable interventions. Following the cessation of     large-scale vector control in highly endemic areas, malaria control efforts have centred on     early diagnosis and treatment of clinical cases and reducing exposure through the use of     insecticide-treated nets (ITNs). While ITNs have been shown to significantly reduce the     burden of malaria additional effective interventions are urgently needed.      Several trials have shown that chemoprophylaxis given to children at weekly or fortnightly     intervals reduces morbidity from malaria in a number of different settings and populations.      An alternative approach has been to use intermittent preventive therapy (IPT) involving the     administration of a full therapeutic dose of antimalarials at regular intervals. This is     logistically easier to deliver, and is less costly, and may reduce problems of promoting drug     resistance associated with regular chemoprophylaxis. Intermittent administration of     sulphadoxine-pyrimethamine (SP) during antenatal clinic visits was shown to be highly     effective in reducing malaria and anaemia in pregnant women and improving infant birth     weights. IPT in pregnancy (IPTp) is now recommended by WHO for endemic regions of Africa.   "
187047|NCT00285675|"     The purpose of this study is to monitor the safety of continued DN-101 and docetaxel     treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC)     Studies.   "
187048|NCT00285688|"     Peptic ulcer disease is the most common gastrointestinal disease. Antibiotic resistant     Helicobacter pylori is a major problem worldwide. The gold standard for Helicobacter pylori     eradication is composed of Proton-pump inhibitor/Ranitidine bismuth citrate + Amoxycillin +     Metronidazole /Clarithromycin. In Thailand, clarithromycin resistant strains increased and     led to treatment failure. Data on file at Rajavithi Hospital showed that metronidazole     resistant H. pylori was about 50% and Clarithromycin resistant strains accounted for 8%. This     molecular genetic study will be performed in patients presenting with dyspepsia, who had an     indication for gastroscopic examination, to explore the incidence of antibiotic resistant     Helicobacter pylori in Rajavithi Hospital, Thailand.   "
187049|NCT00285701|"     Patients referred for colon inspection (colonoscopy) due to suspicion of colon polyps/cancer     will receive local administration of hexaminolevulinate (HAL) prior to colon inspection. Blue     light illumination will induce red fluorescence of polyps and tumours, improving detection of     the polyps and tumors. Different HAL doses will be tested to find the optimal image     conditions. Tolerability measurements will be performed to ensure patient safety.   "
187050|NCT00285714|"     The primary objective of this clinical trial is to assess the influence of orthognathic     surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and     soft tissue, in three dimensions, so enabling the setup of 3D normative value tables.   "
187051|NCT00285727|"     This is an 8 week study for patients who are currently taking antidepressant medication but     not fully responding. Ropinirole CR would be taken in conjunction with current antidepressant     medication. Patients come into the clinic once a week when starting on the medication and     then once every other week for the remainder of the 8 weeks.   "
187052|NCT00285740|"     This study involves a form of group therapy called Cognitive Behavioral Therapy or CBT for     depressed patients with Epilepsy. The CBT groups will be tailored for an epilepsy clinic     population. There are 12 sessions of therapy in the study held once a week for 12 weeks.   "
187053|NCT00285753|"     This study aims at developing and evaluating a support group program for patients with mild     cognitive impairment (MCI) and their partners. These patients have defective memory function     but are not demented. However, there is an increased chance of developing dementia in the     near future; 10-15% per year for MCI patients, in contrast to 1-2% per year for healthy     elderly persons. For the patients and their caregivers this means that they are confronted     with feelings of uncertainty and fear towards the future. They also have many questions about     how to improve their memory problems and how to cope with other changes or consequences.      The purpose of the support group program is to improve coping skills and facilitate     adaptation to the impairments, in order to reduce anxiety or depression and strengthen     feelings of competence in patients and their partners.   "
187054|NCT00293696|"     To evaluate anti-androgen (bicalutamide) induced biological and molecular changes in prostate     comparison to chemical castration induced (goserelin) ones   "
187055|NCT00293709|"     The purpose of this study is to evaluate the safety profile and the effectiveness of     etanercept under usual care settings in patients with PsA treated by dermatologists.   "
187056|NCT00293722|"     The purpose of this study is to evaluate the safety and effectiveness of etanercept under     usual care settings in patients with PsA treated by rheumatologists.   "
187079|NCT00294021|"     Pneumococcus is a major cause of morbidity and mortality. In 2000, a pneumococcal conjugate     vaccine (PCV) was licensed for use in children and is now part of the routine childhood     vaccine schedule. PCV is known to reduce invasive disease and protect against nasopharyngeal     (NP) acquisition of vaccine serotype pneumococci; it also results in an increased risk of     nonvaccine serotype carriage. This study proposes to assess the longterm impact of vaccine on     NP carriage in a setting where there is intense antibody pressure on the ecology of the     pneumococcus. A cross sectional study of pneumococcal NP colonization among American Indian     children will be combined with surveillance for invasive disease in the same population. The     purpose is to determine the impact of community wide PCV use on NP colonization and the     relationship with invasive disease. This longterm safety issue needs to be assessed to fully     evaluate the impact of vaccine on NP ecology and invasive disease.   "
187080|NCT00294242|"     The purpose of this study is to determine if routine membrane sweeping in uncomplicated term     pregnancies increases the rate of pre-labor rupture of membranes.   "
187081|NCT00294255|"     The study aims to assess the efficacy and tolerability of risperidone added to lithium,     valproate or lamotrigine in patients experiencing a manic episode with depressive or     irritable features.   "
187058|NCT00293748|"     This study will determine if the drug Atorvastatin (Lipitor) changes the genetic material     found in blood cells of people with vascular (blood vessel) disease. Vascular diseases affect     the blood flow in the body and can lead to a heart attack or stroke. Information gained from     this study could be used to develop a more reliable blood test that predicts the risk of     heart attack or stroke.      People 21 and older who have two or more risk factors for developing vascular disease are     eligible for this study. Candidates are screened with a medical history, physical     examination, electrocardiogram, ultrasound of the carotid (neck) arteries, blood tests, and     check of blood pressure and heart rate.      Participants are randomly assigned to one of four treatment groups. Three groups receive     Lipitor in a dose of either 10, 20 or 40 milligrams; the fourth group receives a placebo. All     take the study drug for 3 months. In addition, they undergo the following tests and     procedures:      Study Phase I (Months 2-4)      Participants in all groups are seen once a month at the NIH Clinical Center for blood tests     and monitoring of drug side effects.      Study Phase 2 (Months 5-10)        -  Placebo group: Participants are given 40 mg of Lipitor for 3 months (months 5-7) and          seen by a physician once a month during that time. Blood is drawn at the 7-month visit          and then participants are referred back to their physicians. During months 8, 9 and 10,          participants are called once a month to check on their health. Participation ends after          the tenth month.        -  Lipitor group: Participants are referred back to their physicians for months 5 and 6 and          are called once a month. During month 7, they return to the clinic for a follow-up          evaluation and blood test. Participation ends after the seventh month.   "
187059|NCT00293761|"     The purpose of the study is to determine whether a glaucoma therapy is safe and effective in     treating patients with open-angle glaucoma or ocular hypertension   "
187060|NCT00293774|"     A study to determine the effectiveness and safety of the use of metal-on-metal hip     resurfacing (for example the birmingham hip) when compared to conventional total hip     replacement.   "
187061|NCT00293787|"     The purpose of the study is to evaluate the safety and effectiveness of an investigational     therapy for treating patients with open-angle glaucoma or ocular hypertension.   "
187062|NCT00293800|"     The purpose of the study is to evaluate the safety and effectiveness of an investigational     glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.   "
187063|NCT00293813|"     This study is structured to estimate the effect of denosumab, compared to placebo and     alendronate, on several bone parameters.   "
187064|NCT00293826|"     The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe     and effective in the treatment of rheumatoid arthritis.   "
187065|NCT00293839|"     The purpose of this study is to compare the efficacy of DITROPANÂ® XL (oxybutynin chloride)     Extended-Release Tablets and DETROLÂ® LA (tolterodine tartrate extended-release capsules) in     the reduction of urge urinary incontinence episodes during a 12-week treatment period in     patients with overactive bladder. The secondary objective is to compare the tolerability of     DITROPANÂ® XL (oxybutynin chloride) and DETROLÂ® LA (tolterodine tartrate) during a 12-week     treatment period.   "
187066|NCT00293852|"     Heart failure is a condition where the heart does not pump enough blood to the rest of the     body. People with heart failure may have another condition called the metabolic syndrome(     having excess fat in the belly, high blood pressure, high fat in the blood, low level of good     cholesterol and high blood sugar). People who have both heart failure and the metabolic     syndrome often see many doctors. A new clinic has been formed at Ben Taub General Hospital     that includes a specialist in heart failure (cardiologist) and in the metabolic syndrome     (endocrinologist) as well as patient teaching. The goal of this study is to randomize     patients with the metabolic syndrome who are admitted to the hospital for heart failure to     this clinic (collaborative care) versus the usual doctor appointments (usual care). The     purpose of this study is to see if collaborative care is better medical care than usual care.     Specifically, we will see if patients in collaborative care will have:        1. fewer admissions to hospitals for illness        2. better blood pressure, sugar, fat and heart failure control        3. better patient satisfaction and knowledge about their diseases        4. lower levels of inflammation.   "
187067|NCT00293865|"     The purpose of this study is to assess the detection rate and false negative rate of sentinel     lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.   "
187068|NCT00293878|"     The purpose of this study is to evaluate the safety and effects on lipids of FM-VP4     administered for 12 weeks in subjects with mild to moderate primary hypercholesterolemia.   "
187069|NCT00293891|"     A study to assess the safety and effectiveness of tacrolimus cream in the treatment of     psoriasis.   "
187070|NCT00293904|"     The purpose of this study is to evaluate whether the use of a specific immunomodulatory     principle (QbG10) together with conventional grass pollen allergen leads to a more rapid and     more pronounced decrease of sensitivity against pollen than with the grass pollen allergen     alone   "
187071|NCT00293917|"     A study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis   "
187073|NCT00293943|"     The purpose of this study is to investigate the significance of complete versus incomplete     electrical isolation of pulmonary veins by radiofrequency-induced linear lesions in patients     with paroxysmal atrial fibrillation.      The study hypothesis ist that the complete linear PV isolation ablation is superior to the     non-complete linear PV isolation on the outcome of patients with idiopathic drug-refractory     atrial fibrillation. As a second hypothesis in this adaptive study design, the     non-inferiority of the complete linear PV isolation strategy will be tested.   "
187074|NCT00293956|"     This study was designed to evaluate the level of certain hormones (thyroid hormones and     cortisol) in full term or close to full term infants who have respiratory distress severe     enough to require respiratory support. The purpose of this study is to determine if there is     a relationship between these hormone levels and how sick these infants are who require help     with breathing following birth.      Hypothesis: Infants who are born full term or near full term and who have low hormone levels     will have higher severity of illness.   "
187382|NCT00290056|"     We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of     arrhythmic events among post-MI, ICD recipients.   "
187083|NCT00294281|"     Fibromyalgia syndrome (FMS) is a long-term disorder that is characterized by widespread body     pain and tender points in joints, muscles, tendons, and other soft tissues. Other symptoms     associated with the disorder include fatigue and depression. The cause of FMS is unknown, and     conventional treatments are often unsuccessful in adequately relieving pain. For people with     severe, unrelenting pain, which is referred to as refractory FMS, opioid maintenance therapy     may be an option, but it comes with the dangerous potential of addiction and is therefore     avoided if possible. Vagus nerve stimulation (VNS), in which a nerve located in the neck     receives electrical input, may be an option for providing pain relief. The purpose of this     study is to determine the safety, tolerability, and effectiveness of VNS as a treatment for     people with refractory FMS.   "
187084|NCT00294294|"     The purpose of the study is to determine whether prophylactic antipyretic treatment after     vaccination with Prevenar and a concomitant hexavalent DTPa combination vaccine reduces the     rate of febrile reactions.   "
187085|NCT00294307|"     Aim 1. To compare across three hospital sites the effects on health and cost outcomes     observed by the following three interventions, each designed to enhance adaptation and     improve outcomes of hospitalized cognitively impaired elders and their caregivers:        1. augmented standard care (ASC) - standard hospital and, if referred, home care plus early          identification of CI during the patients' hospitalization by trained registered nurses          (RNs) with immediate feedback to patients' primary nurses, attending physicians and          discharge planners;        2. resource nurse care (RNC) - standard hospital and, if referred, home care plus early          identification of CI during the patient's hospitalization by trained RNs and hospital          care by RNs trained in the use of expert clinical guidelines developed to enhance the          care management of hospitalized cognitively impaired elders and to facilitate their          transition from hospital to home; or,        3. advanced practice nurse care (APNC) - standard hospital care plus transitional (hospital          to home) care substituting for standard home care and provided by APNs with advanced          training in the management of CI patients using an evidence-based protocol designed          specifically for this patient group and their caregivers.      [H1] We hypothesize that health and cost outcomes with APNC, a comprehensive intervention     designed to meet the unique needs of cognitively impaired older adults hospitalized for an     acute medical or surgical event and their caregivers will be associated, relative to health     and cost outcomes with ASC and RNC, with improvement in patient, caregiver and cost outcomes.      [H2] We hypothesize that improvements in patient, caregiver and cost outcomes observed for     the RNC group will be greater than those observed for the ASC group.      Aim 2. To compare within each site and over time, health and cost outcomes (identified in Aim     1) from patients treated with either ASC or RNC, both relatively lower intensity     interventions, with the outcomes of patients at the same site observed after switching to     APNC, a high intensity intervention.      [H3] We hypothesize that compared to patients receiving the ASC or the RNC interventions,     patients at the same site will have improved patient, caregiver and cost outcomes after the     site switches to APNC.      [H4] We hypothesize that patient, caregiver and cost outcomes achieved by the groups     receiving APNC interventions at T1 and T2 will be similar.   "
187086|NCT00294320|"     The purpose of this study is to evaluate the performance of two techniques to monitor the     clearance of AK lesions when treated with Aldara 5% cream.   "
187087|NCT00294346|"     The purpose of this study is to look at the safety and effectiveness of an investigational     drug (AV608) when used in subjects who have Social Anxiety Disorder. AV608 is an NK-1     receptor antagonist that exhibits central nervous system activity after oral administration.     The study will compare AV608 to placebo (a medically inactive substance) to see if AV608     helps the symptoms of Social Anxiety Disorder. Eligible subjects will be assigned by chance     to take either AV608 or placebo for 12 weeks. During the study, subjects will be asked about     their overall health and mood and their Social Anxiety Disorder.   "
187088|NCT00294359|"     Although it is possible to cure bowel cancer when it is detected at an early stage, in many     cases it may spread to involve other organs and in these cases is generally incurable.     Chemotherapy prolongs survival and improves quality of life in such patients, but standard     chemotherapy for this disease has not been defined.      There are several possible chemotherapy treatments for patients with bowel cancer, which has     spread to other organs. However, these treatments are only partly effective and only work for     a limited period of time. Most treatments are associated with a number of possible side     effects which may have a detrimental effect on quality of life. Thus, it is imperative that     more effective treatments with the lowest possible risk of side effects are developed.      Previous studies have shown that the addition of a new type of antibody treatment     (bevacizumab) to an intensive combination chemotherapy regimen improved survival in patients     with advanced bowel cancer and extended the time before tumours began to grow. However,     intensive chemotherapy is likely to only be a suitable treatment for a proportion of patients     with bowel cancer, because intensive chemotherapy causes a high rate of side effects.      This study compares a gentle chemotherapy treatment (capecitabine chemotherapy tablets given     by mouth) with the combination of capecitabine and bevacizumab and the combination of     capecitabine, bevacizumab and intravenous mitomycin C.      It is expected that a gentle chemotherapy treatment or a gentle chemotherapy treatment     combined with bevacizumab would be an appropriate treatment for both young and fit patients     as well as older and less fit patients who would not easily tolerate intensive chemotherapy.   "
187089|NCT00294372|"     The general aim is to evaluate the antiviral activity and safety of increasing doses of oral     administered RTV-boosted BILR 355 BS (75 mg and 150 mg twice daily) in HIV-1-infected,     NNRTI-experienced patients, followed by 28 day combination therapy with Tipranavir or     Lopinavir based HAART-regimen   "
187090|NCT00294385|"     The purpose of this study is to compare the Time To Disease Progression (TTDP) between those     patients with unresectable, locally recurrent or metastatic breast cancer who are treated     with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy     of Docetaxel followed by Gemcitabine.   "
187132|NCT00294931|"     This multicenter phase II trial is designed to study the unique combination of chemotherapy     (irinotecan./carboplatin) and bevacizumab in the extensive-stage setting. This clinical     setting seems ideal for evaluation of the role of bevacizumab in delaying progression and     prolonging survival.   "
187091|NCT00294398|"     Specific Aim:      To determine whether a prescription for Inhaled Corticosteroids (ICS) added to standard     Emergency Department (ED) discharge therapy for young children with persistent asthma     symptoms increases ICS use and improves symptoms and quality of life over the months     following the ED visit.      Hypotheses:      In a cohort of pediatric patients with persistent asthma discharged from the ED after an     acute asthma exacerbation, a prescription for ICS will:        1. Improve usage of ICS as measured by refill of a prescription within the first 2 months          after the ED visit        2. Improve symptom severity at two weeks after an ED visit as measured by days of cough,          wheeze, missed school, daycare or work        3. Improve patient and caregiver asthma-related quality of life during the 2 months          following an ED visit measured by asthma Health Related Quality of Life (HRQL)        4. Improve asthma control at 2 months as measured by a validated asthma instrument   "
187105|NCT00294580|"     A trial was conducted in the 1980s to compare two strategies for control of malaria in young     children aged 3-59 months: treatment with chloroquine versus treatment combined with     fortnightly chemoprophylaxis with Maloprim. The impact on mortality and morbidity was     assessed at the time, and their cognitive abilities and educational outcomes were assess 14     years later in 2001. The hypothesis was that the chemoprophylaxis would reduce morbidity and     mortality and would improve cognitive abilities and educational outcomes in the long term   "
187092|NCT00294411|"     The incidence of caesarean section has reached 15-20% in most developed countries.     Encouraging vaginal birth after caesareans section (VBAC) has been considered a key component     of a strategy to reduce the caesarean section rate. Most medical literature has focused on     the efficacy of VBAC in reducing the caesarean section rate and the physical safety of     successful VBAC. However, 30%-40% of these women fail to achieve a vaginal delivery. Little     is known about how the uncertainty of labour outcome and a failed VBAC impact on the     psychosocial function of these women. What we do know is that antenatal depression and     unplanned caesarean section are major risk factors for postpartum depression, which in turn     is the major cause of maternal mortality in many developed countries including Hong Kong. We     propose to study a cohort of women with a prior caesarean section and presenting with a     subsequent pregnancy for care. After consent and recruitment, these subjects will be randomly     assigned to have a repeat caesarean section or VBAC. The medical outcomes, overall     satisfaction of the subjects with the care they received, and the short-term psychosocial     function of these subjects will be studied. The result of this study will provide important     information that would be useful in assisting women to decide the mode of delivery after a     prior caesarean section. The Hypothesis is that there is a significant difference in     psychosocial function between these 2 groups of patients.   "
187093|NCT00294424|"     The aim of this study is to compare the cost-effectiveness of major joint replacement in     patients with short and non-fixed (control group) waiting time (WT). After being placed on     the waiting list, patients will be randomized into two groups through regular contact with     the practice staff: (1) Patients with non-fixed waiting time (patient undergoes hospital's     normal procedure from the date (s)he is added to the waiting list to the date of operation),     and (2) patients with short waiting time (operated in maximum three months). The main     question is: is it possible to improve the cost-effectiveness of major joint replacement by     shortening waiting time?   "
187094|NCT00294437|"     To determine if therapy with Zometa® (zoledronic acid) 4mg will be effective in preventing     the occurrence of bone metastases in prostate cancer patients at high risk of developing     them. In addition, pain and analgesic scores and overall safety are to be evaluated     throughout the study.   "
187095|NCT00294450|"     The purpose of this investigation is to carry out a clinical evaluation of a newly developed     fistula pouching system's ability to function as a good pouch for fistulas, with the opening     on the skin of the stomach or in a wound on the skin of the stomach.   "
187096|NCT00294463|"     Tibolone, a tissue-selective compound with a combination of estrogenic, progestogenic and     androgenic properties, is used as an alternative for estrogen or estrogen plus progesterone     hormone therapy for the treatment of symptoms associated with menopause and osteoporosis. The     current study compares endometrial histology, biochemistry (hormone levels) and     gene-expression profiles after short-term (21-days) treatment with tibolone, to the findings     after treatment with estradiol-only (E2) and E2+Medroxyprogesterone Acetate (MPA) in healthy     postmenopausal women undergoing hysterectomy for endometrial prolaps.      Since short-term tibolone use results in increased spotting and bleeding but long-term     treatment with tibolone has been shown to lead to an atrophic endometrium our hypothesis is     that tibolone first displays a more estrogenic mode of action, which over time, is     counterbalanced by tibolone's progestagenic properties   "
187097|NCT00294476|"     The purpose of this study is to evaluate the safety and efficacy of IVIG in the treatment of     metastatic cancer of the prostate, colon and melanoma.   "
187098|NCT00294489|"     A relatively large proportion of patients with chronic HCV infection have normal or mildly     elevated ALT. Many of these patients are not being treated, and are not being sent for a     liver biopsy. The present study will determine the ability of Methcetin BreathID Test(MBIT)     to detect those patients who will be candidates for anti-viral treatment, as an alternative     measure for liver biopsy in decision-making prior to treatment in clinical hepatology.   "
187099|NCT00294502|"     To study the efficacy of an antibacterial/anticoagulant solution instilled into the     hemodialysis (HD) catheters after each treatment (“antibiotic lock solution - ALS”) to     prevent catheter related bacteremia (CRB) and to salvage catheters with established CRB.   "
187100|NCT00294515|"     This study will determine the relative efficacy and safety of up to 100 days Valcyte     prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of     CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study     treatment is 3-12 months and the target sample size is 100-500 individuals.   "
187101|NCT00294528|"     A randomized blinded study is conducted comparing 2 different knee prostheses. Range of     motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are     registered at intervals up to one year postop, where patients are informed on which     prosthesis they received.      We want to:        -  determine whether an increased ROM is achieved with a high-flex knee compared to a          standard knee        -  and if so, does it matter   "
187102|NCT00294541|"     This trial is a follow-up companion study to Protocol ICA-17043-10, a Phase III,     multi-center, efficacy and safety study of ICA-17043. This is an open-label extension study     collecting safety data on the use of ICA-17043 in subjects with sickle cell disease (SCD)     (e.g., HbSS, HbSC, HbSb0-thalassemia, HbSb+-thalassemia subjects). All subjects who have     successfully completed ICA-17043-10 will, if deemed appropriate by their study Investigator     and appropriate consent by subject is given, enroll in the ICA-17043-12 study (Study 12).     Only patients who participated in ICA-17043-10 are eligible for this open label study   "
187103|NCT00294554|"     The purpose of this research is to evaluate the usefulness of memantine, compared to placebo     (sugar pill), for the treatment of cognitive impairment in patients with idiopathic     Parkinson's disease (PD) and dementia. Memantine is used as a safe and effective treatment     for patients with Alzheimer's disease. Cognitive impairment includes concentration and memory     difficulties. We will look at how well this medication helps your cognitive impairment, how     well you tolerate this medication (including its effects on your motor symptoms of PD) your     activities of daily living, your emotions, and any medical conditions you might have. We will     interview a person you choose as your informant.   "
187104|NCT00294567|"     In patients with hypertension who undergo elective PCI, the effects of long-term     administration of Calblock (azelnidipine) on plaque volume will be determined quantitatively     by 3D-IVUS and compared with those of amlodipine besilate (Norvasc or Amlodin).   "
187107|NCT00294606|"     This will be a prospective, randomized, double-blinded, cross-over clinical trial to compare     the effects of phenylephrine or norepinephrine on cardiac function during carotid artery     surgery in patients under general anesthesia. The effect of the vasopressor on cardiac     function will be measured using electrocardiography, transesophageal echocardiography and     cardiac troponin I intraoperatively and postoperatively. We will use a cross-over pattern     since both drugs exhibit rapid onset and short duration of action. We hypothesize that there     will be less myocardial ischemia associated with the use of norepinephrine when compared with     phenylephrine during carotid artery surgery.   "
187108|NCT00294619|"     The purpose of this study is to evaluate efficacy and safety profile of a new weekly     administered growth hormone preparation compared with placebo in adults with growth hormone     deficiency.   "
187109|NCT00294632|"     The goal of this clinical research study is to find the highest tolerable dose of the drug     lenalidomide (Revlimid, lenalidomide) that can be given with Rituxan® (rituximab) in the     treatment of relapsed mantle cell lymphoma. The safety and effectiveness of this combination     treatment will also be studied in both mantle cell lymphoma and diffuse large B-cell     non-Hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma     (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).   "
187110|NCT00294645|"     The purpose of the study is to compare remote pacemaker follow-up to current standard of care     follow-up. The study will compare the rate of first diagnosis of clinically actionable events     between patients who utilize the Medtronic Carelink® Network (Remote arm) versus patients who     are followed via routine office visits augmented by transtelephonic monitoring (TTM)(Control     arm).   "
187111|NCT00294658|"     The purpose of this trial is to determine if thymectomy combined with prednisone therapy is     more beneficial in treating non-thymomatous myasthenia gravis than prednisone therapy alone.   "
187112|NCT00294671|"     The purpose of this study is to determine if diflunisal can prevent progressive lower leg     nerve damage in patients with familial amyloidosis polyneuropathy.      Funding Source - FDA Office of Orphan Products Development (OOPD); National Institute of     Neurological Disorders and Stroke (NINDS)   "
187113|NCT00294684|"     The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical     trial to evaluate whether long-term treatment with corticosteroids improves the outcome of     the Kasai or gall-bladder Kasai in infants with biliary atresia. In this clinical trial,     ChiLDREN is testing whether corticosteroid therapy following the Kasai will improve bile     drainage and long term outcome in infants with biliary atresia. Subjects in this trial must     start treatment within 72 hours of the Kasai procedure and be part of a prospective study of     the natural history of biliary atresia also being conducted by ChiLDREN     (http://www.clinicaltrials.gov/ct/show/NCT00061828?order=3).   "
187114|NCT00294697|"     Our overall hypothesis is that genetic variations in innate immunity genes predispose     patients to varying responses after injury by altering the systemic and local inflammatory     responses. In addition, we hypothesize that these genetic differences are associated with     different clinical outcomes   "
187115|NCT00294710|"     This study is designed to compare the long-term efficacy and safety of an aliskiren based     regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients     with essential hypertension   "
187116|NCT00294723|"     This trial is conducted in North America (the United States of America (USA) and Mexico).      The trial is designed to evaluate the effects of treatment with liraglutide versus     glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind     trial period plus a 52-week open-label extension (week 104) followed by an additional     156-week continued open-label extension. The total duration of the treatment period is     planned to be 260 weeks (5 years).   "
187117|NCT00294736|"     This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in     patients with advanced NSCLC who currently smoke.      Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers.      In Part II, patients will be randomized 1:1 to two treatment groups: Arm A (Tarceva MTD     established in Part I) and Arm B (150 mg Tarceva daily). Patients in both arms will be     treated for two weeks and then have pharmacokinetic samples collected on day 14. Part II is     open as of Nov-2006.   "
187118|NCT00294749|"     The purpose of this study is to determine whether long antibiotic prophylactic is more     effective than a short traitement in infective complications for prostate biopsy   "
187119|NCT00294762|"     This will be the first prospective study where patients will be selected on the basis of two     measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess     prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy     in highly selected patients with EGFR overexpression and/or EGFR amplification.   "
187133|NCT00294944|"     Assessing the effectiveness of Idazoxan as a treatment for depressive patients who did not     respond to treatment with SSRI   "
187120|NCT00294775|"     The consequence of aortic valve stenosis (AVS) is increased pressure load on the left     ventricle which causes left ventricular (LV) hypertrophy, and myocardial stretch will cause     activation of cardiac peptides and activation of the renin angiotensin aldosterone system     (RAAS). The consequence of LV hypertrophy is increased chamber-stiffness and delayed active     LV relaxation which initially will cause diastolic and later systolic dysfunction. In heart     failure (HF) and ischemic heart disease the degree of diastolic dysfunction has been     demonstrated to correlate with functional class, neurohormonal activation and prognosis which     also recently have been suggested for AVS.      With longstanding elevated filling pressures the left atrium (LA) will dilate. Only limited     data are available on the degree and importance of LA dilatation in AVS.      When apparent, symptoms of HF in AVS are associated with high mortality rates. If LV systolic     dysfunction also is present prognosis will deteriorate further. In these cases aorta valve     replacement (AVR) is recommended. AVR will normalize pressure overload and thereby decreases     LV hypertrophy. Previously it was believed that in time LV hypertrophy regressed towards     normal and even normalized. Recent studies however have demonstrated that LV hypertrophy     regression mainly happens during the first year after AVR, and little subsequent changes are     seen during the remaining 10 years. Furthermore, patients that experience most regression of     hypertrophy have more favourable outcome and better functional class than patients with less     regression of hypertrophy. Thus absence of reverse remodelling is associated with poor     outcome after AVR. Importantly the regression of LV hypertrophy is closely paralleled by     decreasing RAAS hyperactivity.      RAAS hyperactivity may be attenuated pharmacologically with angiotensin II receptor blockers     (ARB) which in systemic hypertension with LV hypertrophy has been associated with reverse     remodelling.      The hypothesis is that in patients undergoing AVR for symptomatic AVS, 12 months post     operative blockade of the angiotensin II receptor will accelerate LV and LA reverse     remodelling, reduce filling pressures and suppress neurohormonal activation compared with     conventional therapy. This will lead to improved exercise tolerance and due to improved left     atrial function reducing the risk of atrial arrythmias.   "
187121|NCT00294788|"     This project aims to test the hypothesis that oral consumption of a specific strain of the     probiotic bacterium Lactobacillus fermentum (trademarked PCC®) is able to significantly     enhance the immune response to a vaccine for influenza.   "
187123|NCT00294814|"     The purpose of this study is to test the hypothesis that using three different techniques to     anastomose coronary grafts to the aorta: partial occlusion, single cross clamp, or using the     Heartstring anastomotic device, will change the amount of gas and solid microemboli as     detected by the EmbodopR transcranial Doppler (TCD) system and consequently the     neurocognitive performance of patients after coronary bypass operation.   "
187124|NCT00294827|"     Survival of colo-rectal cancer patients after liver transplantation.   "
187125|NCT00294840|"     To assess a quantitative kinetic model of FDG uptake measurement using PET in patients with     aggressive Non-Hodgkin's lymphoma and cancer of the pancreas, malignancies with known     variability in disease aggressiveness and prognosis, for optimized tailoring of the     therapeutic strategy in the individual patient.   "
187126|NCT00294853|"     The purpose of the study is to determine if calcium score can be used as a predictor of     coronary artery disease in heart transplanted patients, as it is used in non-transplanted     persons.   "
187127|NCT00294866|"     Studies have shown that patients with ESRD on hemodialysis have high levels of inflammatory     markers which may contribute to the high rates of cardiovascular disease and mortality seen     in these patients. Vitamin D use in dialysis patients has been shown to have a survival     benefit, with paricalcitol at advantage over calcitriol. Since there is some evidence for     involvement of the vitamin D receptor in inflammation, this study is designed to look for an     effect of paricalcitol on markers of inflammation in hemodialysis patients.   "
187128|NCT00294879|"     Introduction Pressure Support Ventilation is widely used in patients in the ICU. Matching the     patient's respiratory needs with adequate ventilator settings is necessary to ensure a low     work of breathing (WOB) and maximal patient comfort. The inspiratory rise time (IRT)     determines the time to reach the selected airway pressure. A short IRT results in a high peak     inspiratory flow and a short time to reach that peak, but is also associated with the     development of turbulent flow, resulting in increased WOB. Aim of this study is to     investigate the effects of different IRT settings on WOB and patient comfort during pressure     support ventilation.      Methods We will performed a prospective, single blind cohort study in patients on Pressure     Support Ventilation. 10 healthy adult patients admitted to the ICU after elective facial or     neck surgery will be included. All patients will be ventilated in pressure support mode using     a Servo 300 ventilator (Siemens. Elema, Solna, Sweden), with a positive end expiratory     pressure of 5 cm H2O, pressure support level of 12 cm H2O above PEEP and an inspiratory     oxygen fraction of 0.40. Patients have to be awake and cooperative (Ramsay 2). WOB will be     measured with an esophageal balloon, and miniature flowmeter (Bicore system). Breathing     comfort will be evaluated using a visual analogue scale (VAS) ranging from 1 to 10. WOB and     patient comfort will be measured (in random order) at 0, 5, and 10% IRT. For statistical     analysis the two-way analysis of variance will used. A p value of < 0.05 will be considered     statistically significant.   "
187129|NCT00294892|"     Primary        -  pharmacokinetics of single dose nevirapine        -  the effect of single dose carbamazepine on the pk of single dose nevirapine        -  resistance against nevirapine before and after.        -  follow-up on HIV status newborns        -  relation between nevirapine levels in cord blood and plasma      Secondary      * safety of single dose nevirapine and nevirapine/carbamazepine      Hypothesis:      Single dose carbamazepine decreases development of resistance to nevirapine in HIV positive     pregnant Tanzanian women by decreasing nevirapine half-life.   "
187130|NCT00294905|"     A controlled study demonstrated that a smoking cessation protocol in routine primary care,     specifically targeted at patients with COPD (SMOCC), doubled the quit rates. The protocol was     tested under optimal trial conditions, but it is unclear if a large-scale implementation     strategy is (cost-)effective. Therefore the present study investigates a large scale     implementation strategy in a 2-armed community intervention trial. The research question is     how (cost-)effective this implementation strategy is compared to usual implementation     procedures.   "
187131|NCT00294918|"     This is an open-label, multi-center, randomized, parallel-group, maintenance trial of     Serostim® in subjects who have completed a prior Serostim® Human Immunodeficiency     Virus-associated Adipose Redistribution Syndrome (HARS) trial (Study 22388). The subjects,     who encountered toxicity during the antecedent protocol, will be assigned to a 1 milligram     (mg) dose. All other subjects will be randomized in 1:1 ratio, to receive up to 2 mg or 4 mg     of Serostim®, beginning from Day 1 of Week 1. Doses will be adjusted downward in subjects     weighing less than 55 kilogram (kg). Serostim® therapy will be continued at the assigned     doses through Week 12 (Period 1). Subjects, who will encounter toxicity during Period 1, will     be assigned to the 1 mg group for Period 2. All other subjects will be randomized in a 1:1     ratio to receive up to 2 mg or 1 mg of Serostim® on a weight adjusted basis. Period 2 therapy     will begin on Day 1 of Week 13, continuing through Week 36. Study visits are required at     Screening (that is, Final Visit of the antecedent trial), Day 1 of Week 1 (Baseline), and at     Weeks 2, 6, 12, 14, 24, 30 and 36.   "
187138|NCT00295009|"     The objective of this clinical investigation is to compare the safety and effectiveness of     ProDisc total disc replacement to spinal fusion surgery in the treatment of discogenic pain     associated with DDD in the lumbosacral spine. There will be separate study arms for one and     two level cases.   "
187140|NCT00295035|"     Colorectal cancer is a major health concern in the Western world with an estimated lifetime     risk of 5-6%. The goal of achieving effective cancer prevention is driven by the prediction     that CRC will become the leading cause of death (surpassing heart disease) in this decade,     with an estimated 1,000,000 new cases and over 500,000 deaths per year, worldwide. Despite     continuing advances in diagnosis and therapy, long-term survival rates have not improved     significantly over the last four decades. Nearly 50% of all CRC patients will die of the     disease. Preventive strategies offer the best hope, at least until our understanding of the     biology of cancer matures to the point where it can be implemented into therapy. The search     for new chemopreventive compounds with minimal toxicity raises particular interest in     phytochemicals.Curcumin (diferuloylmethane) is a natural compound derived from the rhizome of     Curcuma Longa, an East Indian plant, commonly called turmeric. It has been shown to possess     potent anti-inflammatory and anti-oxidative properties, for which it has a long history of     dietary use as a food additive. Curcumin has also a potent anti-proliferative effects against     a variety of cancer cell lines in vitro, which stem from its ability to modulate many     intracellular signal transduction pathways. Human phase I-II studies found curcumin to be     safe, and indicated no dose-limiting toxicity when taken by mouth at doses up to 10 g/day.     This data, together with the dismal therapeutic options available for colon cancer patients,     suggest that curcumin warrants investigation in this setting. The present study evaluates     gemcitabine in combination with curcumin and celecoxib for patients with colon cancer.   "
187141|NCT00295048|"     The purpose of this study is to evaluate the efficacy of an innovative, computer driven     cognitive rehabilitation program for individuals with schizophrenia and related disorders.   "
187142|NCT00295061|"     The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1     Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1     Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult     Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug     on a weekly schedule for 24 weeks.   "
187143|NCT00295074|"     Mild traumatic brain injury (TBI) is a common injury that can produce significant functional     sequelae and ongoing disabling symptoms. Predicting who will have an uncomplicated recovery     and who will suffer ongoing symptoms is difficult. This protocol evaluates the use of     neuropsychologic testing after mild TBI in injured patients to attempt to objectively     establish predictors of long term disability and functional recovery.   "
187144|NCT00295087|"     Women who are affected with premature ovarian failure will exhibit skewed X-chromosome     inactivation patterns compared to women with normal menstrual function (as defined by being     pregnant), indicating a possible X-chromosome defect.   "
187145|NCT00295100|"     The project is a double blind, randomized, placebo-controlled phase II chemoprevention trial.     Study participants will be randomly assigned to receive either tamoxifen or placebo for one     year. Participants will subsequently be followed for one year off of medication. The primary     objective is to evaluate the effectiveness of tamoxifen in reducing breast density by     mammogram.   "
187146|NCT00295113|"     The aim of the study is to observe the ventilatory and cardiac function (included the     pulmonary arterial pressure) during an intermittent work exercise test with high density work     load.   "
187147|NCT00295126|"     This is a randomized open label trial that evaluates the efficacy of an autologous platelet     concentrate (APC) in pre-implantation reconstruction of maxilla.      The sinus occlusion will be performed under general anaesthetic. On one side by the usual     technique with hipbone transplant, the other side will be restored with APC mixed with     autologous bone tissue removed from the surgery site.      The side selection will be determined by the randomization.   "
187148|NCT00295139|"     The main purpose of this study is to determine if the multifaceted treatment for substance     abuse in dual disordered patients is more effective in reducing drug use than a supportive     control treatment. The researchers will also determine if adding a case management component     (Critical Time Intervention; CTI) to the intervention will increase treatment engagement and     retention.   "
187149|NCT00295152|"     The purpose of this study is to determine the effects of community occupational therapy in     older patients with mild ot moderate dementia and their primary caregivers.   "
187150|NCT00295165|"     The purpose of this study is to evaluate if Leukine can induce clinical response or remission     in patients with Crohn's disease.   "
187151|NCT00295178|"     This study is designed to investigate the difference in speed and degree of symptom     resolution between daptomycin and vancomycin in subjects treated for cellulitis or erysipelas     by evaluation of the following parameters:        -  Time to erythema margin cessation to progress        -  Time to defervescence        -  Time to hospital discharge following relief of the presenting cellulitis or erysipelas        -  Degree of improvement of the following signs and symptom of cellulitis or erysipelas          including        -  Degree of improvement of cellulitis-related pain and swelling as reported by subjects      Additionally, the difference in frequency of Adverse Events between daptomycin and vancomycin     will be described.   "
187152|NCT00295191|"     This study aims to investigate the effects of high flux dialyser use and ultra pure dialysate     utilization on cardiovascular disease by evaluating cardiovascular morbidity and mortality,     progression of carotid artery intima-media thickness and coronary artery calcifications,     inflammatory state, lipid levels, nutritional status, and erythropoietin requirement in     hemodialysis patient population. It is hypothesized that both interventions in this project     may diminish cardiovascular disease in hemodialysis patients.   "
187153|NCT00295204|"     Comparing the arrhythmia diagnostic yield of MCOT as compared to standard loop event monitors     in patients presenting with palpitations, syncope or near syncope occurring less frequently     than every 24 hours. Patients randomized and are enrolled for 30 days. Prior testing     required: 24 hours of non diagnostic monitoring,   "
187202|NCT00295867|"     RATIONALE: Zoledronate may delay or prevent bone marrow metastases in patients with breast     cancer.      PURPOSE: This phase II trial is studying how well zoledronate works in treating bone marrow     micrometastases in women with stage I, stage II, or stage III breast cancer.   "
187154|NCT00295217|"     The goal of this study is to validate the new ExAblate Application software V4.2 by     developing additional data that shows the safety of this treatment. The ExAblate is intended     to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine     fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less     than 24 weeks and not seeking treatment for reasons of improving fertility.   "
187155|NCT00295230|"     Studies in preterm infants have shown that adding volume guarantee (VG) to synchronized modes     of ventilation is not only feasible but also advantageous for providing more constant and     desirable mechanical breath size. This ideally minimizes ventilator-induced lung injury due     to barotrauma and volutrauma. To date, only one recent study has investigated the relative     advantages of combining VG with different modes of synchronized mechanical ventilation in     clinically stable, preterm infants that were mechanically ventilated at an average age of one     month. We aim to further evaluate the effects of PSV+VG versus SIMV+VG ventilation in very     low birth weight infants within the first three to five days of life. Our hypothesis is that     in very low birth weight infants requiring mechanical ventilation in the first three to five     days of life, PSV+VG will allow for more stable physiologic and ventilatory parameters     compared to SIMV+VG. The primary endpoints are a reduction in respiratory rate and average     mean airway pressure in the PSV+VG group compared to the SIMV+VG group.   "
187156|NCT00295243|"     Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will     be given Topotecan intravenously on Days 1, 8 and 15.   "
187157|NCT00295256|"     The management of high-risk pregnancies require substantial use of medical resources. Our     goal is to determine the effectiveness of a nurse case management program in which case     managers are assigned to patients with high-risk conditions.      Our hypothesis is that women with diabetes in pregnancy or hypertension who are assigned a     nurse case manager will have lower glucose levels and lower blood pressure levels   "
187158|NCT00295269|"     The purpose of this study is to assess innovative treatment methods in patients with adult     respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS.   "
187159|NCT00295282|"     This is a Phase I dose-escalation study of MDX-1100. patients with ulcerative colitis will be     enrolled into one of four dose cohorts, to receive of MDX-1100 at 0.3, 1.0, 3.0 or 10mg/kg.     Three to six patients will be enrolled at each dose level, starting at the lowest dose level,     for a maximum of 24 patients to be enrolled into the study. The study is designed to     establish the safety and tolerability of single doses of MDX-1100 administered in     dose-escalating cohorts to patients with ulcerative colitis. Other study objectives include     characterizing a pharmacokinetic profile and pharmacodynamic effects of MDX-1100 and     determination of immunogenic response to MDX-1100.   "
187160|NCT00295295|"     Cerebral palsy is a group of disorders characterized by lack of coordination in the muscles,     loss of movement, and speech disturbances. These disorders are caused by injuries to the     brain that occur during fetal development or near the time of birth. The purpose of this     study is to determine the effects of high frequency, low magnitude vibration on bone and     muscle in children with cerebral palsy.   "
187161|NCT00295308|"     Background:        -  Though the drug buprenorphine effectively treats dependence on opioids like heroin, some          abstinent patients relapse to use during treatment. This relapse may be triggered by          stress or stressful situations, and buprenorphine probably has no specific protective          effect in these situations. Buprenorphine probably also has no specific effect on          relapse to cocaine use.        -  Research has shown that clonidine, a drug originally prescribed to treat high blood          pressure and some symptoms of opioid withdrawal, can help block stress-induced relapse          to heroin and cocaine seeking in rats. Researchers are interested in studying whether a          combination of clonidine and buprenorphine may be more effective in preventing drug          relapse than administering one of the medications alone.      Objectives:      - To determine whether clonidine, given to abstinent patients maintained on buprenorphine, is     more effective than placebo in preventing relapse to heroin or cocaine use.      Eligibility:      - Individuals between 18 and 50 years of age who are current cocaine or heroin users seeking     treatment.      Design:        -  The study will last up to 36 weeks, with four phases of treatment and a follow-up          evaluation. Three times a week, participants will be asked to report illicit drug use          and provide urine and breath samples. Throughout the study, participants will receive          individual counseling in weekly 40 60 minute sessions. Other samples and tests will be          scheduled as required by the study researchers.        -  Patients will be stabilized on daily buprenorphine over the first 14 days of the study.        -  Weeks 1 8: Participants will receive vouchers for regular substance-free urine samples.          Those who successfully complete this phase will continue to the next part of the study.        -  Weeks 7 9: Participants will receive either clonidine or placebo along with the          buprenorphine. The dose of clonidine will be stabilized during this time.        -  Weeks 9 22: Participants will continue to receive either clonidine or placebo along with          the buprenorphine. During this part of the study, participants will keep electronic          diaries to record drug use or craving and to record data on mood, stress levels, and          activity.        -  Weeks 23 28: Participants will stop taking the clonidine or placebo, but will continue          the buprenorphine treatment. Participants will continue to keep electronic diaries.        -  Weeks 29 36: Participants will have the choice of transferring to a community clinic          transfer or gradually reducing doses of buprenorphine to end the study.        -  Participants will return for a follow-up visit and urine sample 6 months after the end          of the study.   "
187162|NCT00295334|"     Our specific aim is to explore the effect of moderate alcohol intake on parameters of     glycemic index and lipid profile among patients with type 2 diabetes.   "
187163|NCT00295347|"     The proposed research aims to compare the onset of action and the efficacy of     fludrocortisone, a mineralocorticoid receptor agonist vs. spironolactone, a mineralocorticoid     antagonist, vs. placebo as augmentation to a selective serotonin reuptake inhibitor (SSRI) in     65 inpatients with severe depression. The study will also explore the utility of the     hypothalamic-pituitary-adrenal (HPA) axis in predicting treatment response. The study will be     a 5-week randomized and double-blind trial of fludrocortisone vs. spironolactone vs. placebo     during three years.   "
187164|NCT00295360|"     The expression of transporters involved in bile acid homeostasis is differentially regulated     during obstructive cholestasis. Bile acids are also substrates of the drug efflux transporter     breast cancer resistance protein (BCRP) that is highly expressed in the human intestine.     Therefore we intend to analyze whether intestinal BCRP expression could be altered during     cholestasis.   "
187165|NCT00295373|"     The purpose of this study is to determine whether the effects of rosuvastatin treatment and     exercise training can be synergistic, with respect to the innate immune receptor TLR4,     markers of systemic inflammation, and stimulated production of inflammatory cytokines, in     hypercholesterolemic subjects. It is hypothesized that a rosuvastatin and exercise     intervention will synergistically lower measured variables, so as to be anti-inflammatory.   "
187166|NCT00295386|"     The present study examines the short- and long-term clinical efficacy of cognitive-behavior     therapy and pharmacological treatment in patients suffering from late-life primary insomnia.     46 subjects suffering from chronic primary insomnia were randomized into either     cognitive-behavior therapy (CBT, n=18), hypnotics (7.5 mg Zopiclone, n=16), or placebo     treatment (n=12). All active treatments lasted 6 weeks with follow-ups conducted at 6 months.     Ambulant clinical polysomnography (PSG) and sleep diaries were used on all three assessment     points.   "
187167|NCT00295399|"     The goal of this project is to develop a low-cost, user-friendly, portable telerehabilitation     system for physical therapy of the upper limb after stroke or traumatic brain injury. The     system is based on the use of a commercially available force feedback joystick and will work     with an ordinary home PC and a standard high-speed internet connection. Using the joystick,     the patient will perform exercises designed to aid in recovering motor function of the hand     and arm. The joystick will be programmed to either assist or resist the patient's movements.     The system will include sophisticated analysis of patient status and progress to provide the     therapist and physician with detailed information. In the first phase of the study, we will     develop the system in cooperation with the physical therapy staff and other rehabilitation     specialists. The investigators will examine the usability, comfort, safety and therapeutic     benefit of the system. In the second phase of the study, the investigators will employ the     system in patients' homes, using the internet to connect to rehabilitation specialists in the     clinic. The study hypothesis is that it is possible to adapt commercially available, low cost     gaming equipment such as force feedback joysticks to provide therapy for patients in their     own homes, and that patients will be able to work with this system and will find it enjoyable     and helpful for recovering motor function.   "
187168|NCT00295412|"     The lifetime of substance use disorders in schizophrenia is close to 50%. Substance abuse in     schizophrenia is associated with negative consequences. Unfortunately, there no clear     guidelines for the pharmacological treatment of this dual diagnosis population. Preliminary     results suggest that second-generation antipsychotic drugs (mainly clozapine) may relieve     drug cravings in schizophrenia. We performed a 12-week pilot study to evaluate the impact of     quetiapine, a second-generation antipsychotic, on substance abuse parameters, psychiatric     symptoms and side effects in patients schizophrenia and comorbid substance use disorders. Our     expectation was a 20 % decrease in drug cravings from baseline to end-point.   "
187169|NCT00295425|"     Psoriasis is an immuno-mediated skin disorder, which affects about 2-3% of the population     worldwide. For moderate-severe forms of psoriasis systemic immunosuppression is the treatment     of choice. This clinical trial was initiated to compare the safety and effectiveness of     mycophenolate mofetil and cyclosporine A for the treatment of psoriasis. Patients are     randomized to receive either 2.5 mg/kg BW cyclosporine A or 1 g bid mycophenolate mofetil. If     after six weeks no decrease in the PASI score occures cyclosporine A doses are increased to 5     mg/kg BW for additional six weeks. In the other arm mycophenolate mofetil is increased to 1 g     tid for additional six weeks.   "
187170|NCT00295438|"     The aim of this clinical trial is to evaluate the concordance of diagnosis of injuries in     thoracoabdominal trauma using two different echographic methods. The first method is a     robot-based tele-echography performed by radiologists in a remote location. The second is     bedside echography performed by emergency physicians according to the FAST (Focussed     Assessment by Sonography of Trauma) examination.   "
187171|NCT00295464|"     Administration of steroid to the mother in imminent preterm delivery is a known effective     practice to decrease the risk of respiratory distress syndrome and intraventricular     haemorrhage in preterm infants if given with a week of the preterm delivery. This randomized     clinical trial is performed to test the possibility whether the repeat dose of steroid     results in further reduction of these diseases in case the mother is in imminent preterm     delivery more than a week after the first antenatal steroid treatment.   "
187172|NCT00295477|"     The study is intended for individuals who are doing well on HAART therapy. In Step 1 of the     trial, individuals will be given up to 6 infusions of the study drug VRX496 to see the effect     on viral load and CD4 counts. If individuals have no serious adverse effects from the     infusions of VRX496 and the viral load and CD4 counts remain stable, they may go on to Step 2     of the study. In Step 2, individuals will stop taking their HAART medication and their viral     load, CD4 counts and the number of VRX496 in T cells will be monitored.      All subjects who receive VRX496 T cells will enroll in a Long-Term Follow-up study to monitor     subjects. Subjects will be followed every 6 months for five years following the 1st infusion     of the T cells. If the VRX496 T cells are no longer found in the blood after five years, then     subjects will be contacted yearly for the next 10 years. If the VRX496 T cells are found in     the blood at five years after the 1st infusion of T cells, then the subjects will continue to     be seen once a year until the VRX496 T cells are no longer found in the blood for a maximum     of 15 years.   "
187173|NCT00295490|"     Osteoarthritis of both the knee and hip joints are common conditions; knee osteoarthritis     affects 6% of adults over 30 years of age and osteoarthritis of the hip affects between 3%     and 6% of the Caucasian population. Both forms of osteoarthritis are associated with     disability. Conventional treatment (analgesics and the use non-steroidal anti-inflammatory,     NSAIDS) is prophylactic, aimed at decreasing pain and improving function. However long term     use of NSAIDS is associated with a high incidence of adverse events (gastrointestinal tract     symptoms). A safer alternative treatment would therefore be beneficial.      Both anecdotal evidence and recent studies have implicated the potential of the herbal remedy     Devil's Claw (Harpagophytum procumbens) for the treatment of painful, chronic arthritic type     conditions (Ernst and Chrubasik, 2000). Devil's Claw is an extract obtained from the root of     the Harpagophytum procumbens plant, a member of the sesame family found in the Kalahari     region in South Africa. It has been shown that this herbal remedy has anti-inflammatory and     analgesic effects (Baghdikian et al, 1997). Currently Devil's Claw is marketed for use as a     supportive treatment of degenerative arthrosis, is not a Medicines Control Agency licensed     product and is freely available to the general public in health food stores and pharmacies.      The objectives of this study are to assess the efficacy, optimum dosage and safety of the     herbal remedy Devil's Claw (Harpagophytum) in the treatment of osteoarthritis of the knee     and/or hip. The primary objective of this study is to investigate the following three     principal questions:        1. To compare the efficacy of Devil's Claw with placebo in the treatment of osteoarthritis          of the knee and/or hip        2. To determine the optimum dose of Devil's Claw and        3. To evaluate the safety and tolerability of three doses of Devil's Claw in the treatment          of osteoarthritis of the knee/hip and to compare them to placebo There are also a number          of secondary research objectives that will also be addressed (see later).      These objectives are based on the following hypotheses :      Hypotheses        -  Devil's Claw has anti-inflammatory properties (as assessed by the reduction in pain,          stiffness and disability aspects on the WOMAC) in chronic osteoarthritis of the knee          and/or hip after 16 weeks of treatment, as compared to placebo.        -  A dose response effect exists in the treatment of osteoarthritis of the knee/hip by          Devil's Claw.   "
187174|NCT00295503|"     To estimate the time to progression of cancer in patients with previously untreated     mesothelioma receiving cisplatin, pemetrexed and bevacizumab   "
187186|NCT00295659|"     Diabetes in pregnancy or gestational diabetes (GDM) is a condition that, if left untreated,     may lead to complications for the mother and her baby. It is still not known which is the     best method to diagnosis GDM. The goal of this study is to compare three well-accepted     methods for diagnosis of GDM (using either 75 g or 100 g in the glucose tolerance test) and     determine which method is the easiest and least expensive to use in relation to the reference     method used over the last 20 years. The goal is to see if they can equally predict the     healthy outcome of the pregnant mother and her newborn.   "
187175|NCT00295516|"     In pregnancies complicated by Rhesus disease, the mother has developed antibodies which cross     the placenta and can cause anemia and death of the fetus. When the anemia is detected on     time, the fetus can be saved by giving it blood transfusions during the pregnancy.      The standard test to predict whether the fetus needs a blood transfusion is examination of     the amniotic fluid. To obtain this fluid a needle has to be inserted in the womb, which has a     risk of preterm delivery, infection, and making the disease worse. This is called     amniocentesis.      A new safe test, using Doppler ultrasound, has been developed to possibly replace the     amniocentesis.      The aim of this study is to compare the new Doppler test with the standard amniocentesis. If     the Doppler test is at least as good, this safe test may replace the amniocentesis in the     management of pregnancies with Rhesus disease.   "
187176|NCT00295529|"     There is an urgent need for a knowledge translation strategy to facilitate the integration of     genetics into family medicine, to improve the low knowledge base of most Canadian family     physicians, ensure that the needs are met of those in the population who could benefit from     genetic assessment, and facilitate evidence-based decision-making in the face of increasing     patient demand.      We have developed a multi-faceted intervention incorporating three distinct knowledge     translation strategies: interactive educational sessions, a portfolio of tools for use in     clinical practice and an innovative, efficient, information technology-based knowledge     service designed to provide timely (just-in-time) information which reflects both topical     genetics issues and the pattern of users' queries (a so-called push-pull approach).      We hypothesize that a multi-faceted knowledge translation intervention will improve the     delivery of genetics services by family physicians.   "
187177|NCT00295542|"     The MAPEC study was designed to investigate whether normalizing the circadian blood pressure     profile towards a more dipper pattern (increasing the diurnal/nocturnal ratio of blood     pressure) by the use of Chronotherapy (that is, taking into account the time of day of     administration of antihypertensive medications) reduces cardiovascular risk.   "
187178|NCT00295555|"     Few studies have reported the effect of alpha1-adrenergic antagonists on 24-h blood pressure     and regulation of sympathetic nervous activity in hypertensive patients with diabetic     nephropathy. Using ambulatory blood pressure monitoring devices equipped with spectral     analysis of heart rate variability, we assess the effects of doxazosin on blood pressure in     diabetic nephropathy patients and compare the results with those in patients with essential     hypertension, patients with diabetes mellitus and patients with chronic nephropathy.   "
187179|NCT00295568|"     This study will examine how the two sides of the brain interact when learning precision hand     movements. Both sides of the brain are active when a person performs an accurate hand     movement. This study will look at the extent to which the two brain hemispheres interact when     learning accurate hand movements.      Healthy, right-handed normal volunteers 18 - 40 years of age may be eligible for this study.     Candidates are screened with a clinical and neurological examination.      Participants are randomly assigned to one of two groups - precision or non-precision hand     movements. All participants undergo the following procedures:        -  Force precision task: Subjects are press a small device between the thumb and index          finger. The force produced with the fingertips is translated onto a computer screen.          Subjects track a white line passing on the screen with their fingertips.        -  Paired-pulse transcranial magnetic stimulation (TMS): A wire coil is held to the          subject's scalp. A brief electrical current is passed through the coil, creating a          magnetic pulse that stimulates the brain. During the stimulation, the subject may be          asked to tense certain muscles slightly or perform other simple actions. The stimulation          may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click          and feel a pulling sensation on the skin under the coil. The effect of paired-pulse TMS          on the muscles is detected with electrodes taped to the skin on the arms or legs.        -  Surface electromyography (EMG): This test measures the electrical activity of muscles.          For this test, electrodes are filled with a gel and taped to the skin over the muscle to          be tested.      The study involves six sessions. Sessions 1-5 are on consecutive days; session 6 is one week     after session 5.        -  Session 1: Familiarization with the motor task and baseline measurements, including          error rate, EMG, and paired-pulse TMS        -  Session 2: Training in the motor task and repeat measurements as in session 1        -  Session 3: Training and measurements as in session 2        -  Session 4: Training and measurements as in session 2        -  Session 5: Training and measurements as in session 2        -  Session 6: Measurements only   "
187180|NCT00295581|"     This study, conducted at Johns Hopkins University Center for Immunization Research in     Washington DC, will test the safety and immune response of healthy volunteers to two     experimental malaria vaccines. Malaria is a disease of red blood cells caused by a parasite     that spreads from person to person by mosquitoes. It affects people of all ages, but is     particularly severe in children. Patients may have a high fever, chills and muscle aches.     They sometimes can have severe complications that may even result in death.      The vaccines in this study are called transmission blocking vaccines. These vaccines     stimulate the person's immune system to produce antibodies against malaria. When a mosquito     bites a vaccinated person, it ingests some of the person's blood. The antibodies in the     ingested blood stop the malaria parasite from developing inside the mosquito. The mosquito     would not be able to transmit malaria to other people. PpPfs25/ISA51 (Vaccine A) stimulates     production of antibodies against the malaria parasite Plasmodium falciparum, and     ScPvs25/ISA51 (Vaccine B) stimulates antibodies against the malaria parasite Plasmodium     vivax. The vaccines also contain a substance called Montanide ISA51, which boosts the immune     response to the vaccine.      Healthy volunteers between 18 and 50 years of age may be eligible for this study. Candidates     are screened with a medical history, physical examination, and blood and urine tests. Women     who are able to become pregnant have a urine pregnancy test before each immunization.      Participants are randomly assigned to receive two injections, spaced 4 months apart, of     either Vaccine A or Vaccine B at one of three doses-high, medium, or low. Two subjects in     each dose group additionally serve as controls and receive only Montanide ISA51 mixed with     saline. The vaccine is injected into the muscle of the upper arm. Subjects are monitored for     30 minutes after each injection for possible side effects and take home a diary card to     record their temperature and any symptoms that may appear over the next 13 days.      A blood sample is drawn before and on several occasions after each vaccination to check the     subject's health and to evaluate the immune response to the vaccine. At 1, 3, 7, 14, and 21     days after each vaccination, participants come to the clinic for a check of vital signs     (temperature, pulse, respiration, and blood pressure), brief physical examination, and     history of symptoms since the previous visit.   "
187181|NCT00295594|"     To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids     together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.   "
187182|NCT00295607|"     This is an exploratory study to evaluate the impact of eliminating steroid administration     upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in     patients transplanted for HCV cirrhosis.   "
187183|NCT00295620|"     The study assesses the effect of further 2 years vs further 5 years of adjuvant treatment     with anastrozole after initial 5 years of adjuvant endocrine therapy.   "
187184|NCT00295633|"     The purpose of this clinical research study is to learn whether Saxagliptin added to     thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2     diabetic subjects who are not sufficiently controlled with TZD alone   "
187185|NCT00295646|"     The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the     comparison of zoledronate added to standard adjuvant therapy with controls according to     disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer     treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard     adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal     blockade combined with an antiestrogen or aromatase inhibitor.   "
187187|NCT00295672|"     Our aim is to conducted a multicenter phase II trial of the cisplatin-oral vinorelbine     -radiotherapy combination after induction chemotherapy with cisplatin-docetaxel in patient     with NSCLC. Oral vinorelbine will be used in the present study rather than the intravenous     form because: 1- Previous investigations have demonstrated that oral vinorelbine is as     effective as the intravenous form in the treatment of NSCLC. 2 - We think that the use of     oral agents in CT will reduce some disagreements provoked by intravenous injections: stress,     infections, hemorrhage, displacement at the hospital and cost of CT.   "
187188|NCT00295685|"     The purpose of this study is to determine if people taking lansoprazole two times a day to     control severe GERD symptoms can be controlled just as well, if not better, by taking Nexium     just once a day.   "
187189|NCT00295698|"     The impact of lymphatic filariasis (LF) on HIV is assessed by measuring HIV viral load before     and after DEC treatment of filariasis in double-infected individuals. The impact of HIV on     lymphatic filariasis is assessed by measuring the success of DEC treatment on W. bancrofti     antigenaemia and microfilaraemia in double-infected individuals. The effect of DEC treatment     in individuals with lymphatic filariasis and/or HIV is assessed by measuring the pre- and     post-treatment level of HIV viral load, immunological responses and micronutritional     parameters, including antioxidants and markers of oxidative stress, in single- or     double-infected individuals. The study is carried out as an anonymous, unlinked and     double-blind placebo controlled study with cross-over design. The study groups comprise: 1)     18 double-infected individuals (HIV+/LF+), 2) 16 HIV infected individuals (HIV+/LF-) and 3)     25 individuals with lymphatic filariasis (HIV-/LF+). Based on stratified, blocked     randomisation the study participants receive DEC treatment or placebo. Pre- and     post-treatment (1 week, 12 weeks and 24 weeks post-treatment) blood samples are collected and     analysed for HIV viral load, CD4+ T cell count, distinctive Th1 and Th2 cytokines,     circulating filarial antigens (CFA), micronutrient status, antioxidant enzymes and markers of     oxidative stress. After 12 weeks the study participants get the opposite treatment and     post-treatment blood samples are collected four times with the same intervals as above.   "
187190|NCT00295711|"     The primary objectives of this placebo-controlled clinical trial are to evaluate the     analgesic efficacy and safety of bicifadine at three oral dose levels compared with placebo     in patients with moderate to severe chronic low back pain.      The secondary objectives are to investigate the dose-response relationship of three dose     levels of bicifadine, to evaluate the clinical meaningfulness of bicifadine efficacy, to     evaluate the effect of bicifadine on function and general quality of life, to describe the     population pharmacokinetics of bicifadine in patients with chronic low back pain, and to     evaluate safety following discontinuation of bicifadine treatment.   "
187191|NCT00295724|"     -  The primary objectives of this placebo-controlled clinical trial are to evaluate the          analgesic efficacy and safety of bicifadine 200 mg BID compared with placebo in patients          with moderate to severe chronic low back pain.        -  The secondary objectives are to evaluate the effect of bicifadine on function and          general quality of life, to evaluate safety following discontinuation of bicifadine          treatment and to investigate the population pharmacokinetics of bicifadine.   "
187192|NCT00295737|"     The primary objective of this study is to isolate macrophages by using bronchoalveolar lavage     (BAL) for different in vitro experiments.      Therefore, following a baseline BAL, allergen, endotoxin, and saline will be instilled into     three different lung segments during the first bronchoscopy. After 24 hours during a second     bronchoscopy, BAL fluid will be collected in these challenged segments to harvest invaded     cells for in vitro experimentation. In addition, segmental bronchial biopsies will be taken     to assess the degree of local inflammation.   "
187193|NCT00295750|"     The study was a three-arm, active-control, multi-centre, parallel group study.   "
187194|NCT00295763|"     Patients diagnosed with thyroid cancer are commonly treated with surgery to remove their     thyroid gland followed by radioiodine ablation to destroy any remaining parts of the thyroid     gland that may have been missed during surgery. It is thought that ablation with radioiodine     destroys normal remaining thyroid tissue as well as cancerous cells either in the thyroid     area or at other sites.      Following successful treatment, patients are then monitored by their physicians at regular     intervals with testing to detect any recurrence of thyroid cancer throughout the body. If     thyroid cells are detected by these follow up tests, the physician will decide the best     method to re-treat the patient.      In 2001-2003 Genzyme conducted a clinical study to test if Thyrogen® can be used to     accomplish radioiodine ablation treatment. This study aimed to determine that the success     rates of radioiodine ablation were comparable when patients were prepared for ablation with     Thyrogen® while being maintained on their normal thyroid hormone therapy, or, alternatively,     by thyroid hormone withdrawal. Thyroid hormone withdrawal commonly causes uncomfortable side     effects for patients, and these might be avoided by the use of Thyrogen.      Eight months after the initial Thyrogen plus radioiodine treatment to achieve ablation, all     patients in both groups were given Thyrogen® to test for any remaining thyroid tissue. The     results of this testing showed that all patients (in both groups) had successfully achieved     remnant ablation and had no detectable thyroid tissue remaining.      In order to confirm these remnant ablation results we will conduct follow up testing in this     study for all patients that were enrolled in the previous study and we also will determine if     their thyroid cancer has recurred. Only patients who completed this previous Thyrogen     ablation study are eligible for entry into this study.   "
187195|NCT00295776|"     To assess the efficacy of Lamictal for the treatment of pain and reduction of allodynia in     patients with post herpetic neuralgia.   "
187196|NCT00295789|"     To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel     plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer   "
187197|NCT00295802|"     The purpose of this study is to determine the substantial equivalence of the Ablatherm high     intensity focused ultrasound (HIFU) as compared to cryotherapy for the treatment of low risk,     localized prostate cancer.   "
187198|NCT00295815|"     This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of     recurrent brain cancer (specifically intracranial glioblastoma multiforme).   "
187199|NCT00295828|"     The purpose of this study is to determine if a drug called Macugen may help to stop the     growth of abnormal blood vessels on the iris that has occurred in the eye(s) as part of     diabetic retinopathy.   "
187200|NCT00295841|"     RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when     given together with cytarabine and to see how well they work in treating patients with     refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.   "
187201|NCT00295854|"     To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg     once daily vs. placebo in patients with Interstitial Cystitis.   "
187203|NCT00295880|"     Rationale: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's     immune system from rejecting the donor's stem cells. When the healthy stem cells from the     donor's umbilical cord blood are injected into the patient's bone marrow they may help make     stem cells, red blood cells, white blood cells, and platelets.      Purpose: This phase I/II trial is studying the side effects of donor umbilical cord blood     transplant when given directly into the bone marrow and to see how well it works in treating     patients with hematologic cancer.   "
187204|NCT00295893|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as     trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Giving combination chemotherapy with or without trastuzumab before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed. It is not yet known whether combination chemotherapy is more effective with or     without trastuzumab in treating breast cancer.      PURPOSE: This randomized phase II trial is comparing two different regimens of combination     chemotherapy given together with or without trastuzumab to see how well they work in treating     patients with stage II or stage III breast cancer.   "
187205|NCT00295906|"     RATIONALE: Computer-based continuing education courses may be effective in improving the     skills of primary care doctors to identify skin cancer risk factors, perform skin cancer     exams, and counsel patients. They may also improve the skills of primary care doctors to     assess and counsel patients on their weight, diet, and physical activity.      PURPOSE: This randomized clinical trial is studying how well computer-based continuing     education courses work in improving doctors' ability to perform skin cancer or weight control     exams and counseling during routine office visits.   "
187206|NCT00295919|"     RATIONALE: Drugs used in chemotherapy, such as fenretinide LXS, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.      PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide LXS in     treating patients with recurrent, refractory, or persistent neuroblastoma.   "
187207|NCT00295932|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and prednisone,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer     growth in different ways. Some block the ability of cancer cells to grow and spread. Others     find cancer cells and help kill them or carry cancer-killing substances to them. Giving     bortezomib together with cyclophosphamide, prednisone, and rituximab may be an effective     treatment for non-Hodgkin's lymphoma.      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of     bortezomib when given together with cyclophosphamide, prednisone, and rituximab and to see     how well it works in treating patients with relapsed or refractory indolent B-cell     non-Hodgkin's lymphoma.   "
187208|NCT00295945|"     RATIONALE: Giving pain medication into the space between the wall of the spinal canal and the     covering of the spinal cord or giving it into a vein may help lessen pain caused by cancer     surgery. It is not yet known whether epidural analgesia is more effective than     patient-controlled analgesia in controlling pain in patients who have undergone surgery for     gynecologic cancer.      PURPOSE: This randomized clinical trial is studying epidural analgesia to see how well it     works compared to patient-controlled analgesia in treating patients who have undergone     surgery for gynecologic cancer.   "
187209|NCT00295958|"     RATIONALE: The LMB-2 immunotoxin can find tumor cells and kill them without harming normal     cells. Vaccines made from peptides may help the body build an effective immune response to     kill tumor cells. Giving LMB-2 immunotoxin together with vaccine therapy may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving LMB-2 immunotoxin together with     vaccine therapy works in treating patients with metastatic melanoma that cannot be removed by     surgery.   "
187210|NCT00295971|"     RATIONALE: Giving chemotherapy and total body irradiation before a donor bone marrow     transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It     also helps stop the patient's immune system from rejecting the donor's stem cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving antithymocyte globulin and removing the T cells from the donor cells before transplant     may stop this from happening.      PURPOSE: This phase I trial is studying the side effects and best dose of donor T cells and     antithymocyte globulin when given together with chemotherapy and total-body irradiation in     treating young patients who are undergoing T-cell depleted donor stem cell transplant for     myelodysplastic syndrome, leukemia, bone marrow failure syndrome, or severe immunodeficiency     disease.   "
187211|NCT00295984|"     RATIONALE: Nicotine may stimulate the immune system to kill Kaposi's sarcoma cells.      PURPOSE: This phase II trial is studying the side effects and how well the nicotine skin     patch works in treating patients with Kaposi's sarcoma.   "
187212|NCT00295997|"     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem     cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It     also stops the patient's immune system from rejecting the donor's stem cells. The donated     stem cells may replace the patient's immune system and help destroy any remaining cancer     cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor     lymphocyte infusion) after the transplant may help increase this effect. Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate     mofetil after transplant may stop this from happening.      PURPOSE: This clinical trial is studying how well a donor stem cell transplant works in     treating patients with hematologic cancer, metastatic kidney cancer, or aplastic anemia.   "
194033|NCT00385645|"     The study compares the adherence of 240 HIV-negative subjects randomly assigned to 2     different antiretroviral therapies for 28 days after accidental exposure to HIV.   "
187213|NCT00296010|"     RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, and liposomal     doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor     cells that remain after surgery. It is not yet known whether giving liposomal doxorubicin     after surgery is more effective than observation or cyclophosphamide and methotrexate in     treating breast cancer.      PURPOSE: This randomized phase III trial is studying liposomal doxorubicin to see how well it     works compared with observation or cyclophosphamide and methotrexate in treating older women     who have undergone surgery for breast cancer.   "
187214|NCT00296023|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor     bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells.     It also stops the patient's immune system from rejecting the donor's stem cells. The donated     stem cells may replace the patient's immune system and help destroy any remaining cancer     cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor     lymphocyte infusion) after the transplant may help increase this effect. Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving antithymocyte globulin before transplant and methotrexate and tacrolimus after     the transplant may stop this from happening.      PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in     treating older or frail patients with hematologic cancer.   "
187215|NCT00296036|"     RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or     lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving     pyridoxine with or without topical urea/lactic acid-based cream is more effective than     topical urea/lactic acid-based cream alone or a placebo in preventing hand-foot syndrome.      PURPOSE: This randomized phase III trial is studying pyridoxine and topical urea/lactic     acid-based cream to see how well they work compared with giving pyridoxine together with a     placebo, giving topical urea/lactic acid-based cream together with a placebo, or giving two     placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for     breast cancer or other cancer.   "
187216|NCT00296049|"     RATIONALE: Antibiotics, such as daptomycin and vancomycin, may be effective in treating     bacteria in the blood. It is not yet known whether daptomycin is more effective than     vancomycin in treating bacteria in the blood in patients with neutropenia caused by     chemotherapy.      PURPOSE: This randomized clinical trial is studying daptomycin to see how well it works     compared with vancomycin in treating bacteria in the blood in patients with neutropenia     caused by chemotherapy.   "
187217|NCT00296062|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some find tumor cells and kill them or carry tumor-killing substances to     them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may     also block blood flow to the tumor. Giving combination chemotherapy together with bevacizumab     may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine     when given together with irinotecan and oxaliplatin with or without bevacizumab and to see     how well they work in treating patients with metastatic or locally advanced colorectal cancer     or other solid tumors that cannot be removed by surgery.   "
187218|NCT00296088|"     Obesity is a significant health care issue in the United States, particularly among the     critically ill. Preliminary research has shown that differences in ventilator management     exist among obese and non-obese individuals. This study will examine the effect of excess     weight on ventilator management and clinical outcomes in individuals in an intensive care     unit (ICU).   "
187219|NCT00296101|"     Physical inactivity is a major public health problem in the United States. Research has shown     that physical activity levels decline during adolescence, and the decline is greater in     females than males. The purpose of this study is to evaluate a life-skills oriented physical     activity intervention at increasing activity levels and decreasing cardiovascular risk     factors in adolescent females.   "
187220|NCT00296114|"     To prospectively collect serum and DNA samples from subjects with pancreatic cancer,     pancreatitis, liver disease, and from healthy and at-risk volunteers in order to identify     novel biomarkers for early diagnosis, differential diagnosis, stage, natural history of the     disease, response to treatment, and to identify novel targets for therapeutic interventions.     In particular:   "
187221|NCT00296127|"     To evaluate the bioavailability of celecoxib administered as capsule contents sprinkled onto     applesauce relative to intact capsule   "
187223|NCT00296153|"     The purpose of this study is to evaluate the effect of Omacor 4g/day on blood lipid     parameters and on the function and stiffness of blood vessels in HIV infected patients on     Antiretroviral Therapy (HAART)   "
187224|NCT00296166|"     Patents with atrial fibrillation can be treated with the purpose of curing the     arrhythmia.This may be achieved by catheter ablation and Maze surgery where the latter     includes open heart surgery.      By catheter ablation the arrhythmia can be cured in about 70 % of patients who have episodes     of atrial fibrillation. In patients with permanent atrial fibrillation the results are not as     good.      We will compare a conventional ablation approach where lesions are created on the inside of     the heart with a thoracoscopic approach where the lesions are created from the outside of the     heart.   "
187225|NCT00296179|"     To demonstrate overall improvement of insomnia in subjects treated with zolpidem tartrate     extended-release (Ambien CR) and escitalopram (Lexapro) vs. subjects treated with placebo and     escitalopram at 2 months.   "
187274|NCT00288639|"     The objective of study is to assess the clinical improvement (change in seizure frequency),     safety, and tolerability of subjects with partial seizures following adjunctive therapy of     pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.   "
187277|NCT00288678|"     1. To demonstrate a feasible hospital-based diabetic shared care model in Taiwan.        2. To compare effectiveness of diabetes control between patients receiving case management          provided by a health manager and patients receiving usual care.        3. To determine the optimal level of glucose, blood pressure and lipids in control of          diabetes in Taiwan.   "
187226|NCT00296192|"     The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM     952) in a single dose application scheme.      Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be     checked. Subjects will then be hospitalized for one night. In the morning of the next day,     subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then     receive a single dose of trial medication. Safety assessments after application include     adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and     laboratory checks. Efficacy will be assessed by application of motor examination scores.      The first subject is planned to be enrolled in February 2006. The last subject is planned to     be enrolled in May 2006. Last subject out is expected for August 2006.   "
187227|NCT00296205|"     The purpose of this study is to determine what percentage of patients receiving high-dose     Cyclophosphamide may experience a halt in the worsening of their disease or experience     improvement of their disease and for how long the benefit may last.   "
187228|NCT00296218|"     Primary Objective        -  The main objective of this study is to assess if a two-month regimen of irbesartan in          patients hospitalized for acute coronary syndrome without ST segment elevation can          reduce inflammation markers (ie hsCRP), in comparison to a similar regimen of enalapril.      Secondary Objectives        -  To compare both regimens on several other biological parameters which have demonstrated          their relevance and their predictive clinical value (ie BNP, microalbuminuria, troponin          I …) in this patient population.        -  To compare on the above parameters the early initiation of treatment versus the          initiation of treatment at hospital discharge.   "
187229|NCT00296231|"     The purpose of this study is to test whether application of high frequency ventilation     through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.   "
187230|NCT00296244|"     The purpose of this study is to determine whether steroid-related complications can be     avoided by using steroid-free immuno-suppressive drug regimen after liver transplantation.   "
187231|NCT00296257|"     To compare the efficacy of SMP-114 (120 and 240 mg/d) versus placebo in terms of the     percentage of patients meeting the American College of Rheumatology criteria for 20%     improvement in RA (ACR20) at week 24. The study hypothesis would be to demonstrate that the     use of methotrexate and SMP-114 is more efficacious than Methotrexate alone.   "
187232|NCT00296270|"     Objectives: To determine whether people systematically misremember the “myths” (false     information) as true, and to assess effects on perceptions of risk and behavioral intentions.   "
187233|NCT00296283|"     This pilot study is looking at the effects of a brief psychoeducational workshop. These one     day workshops are designed to increase family members knowledge about bipolar disorder and to     help with processing emotions that go along with having a relative with bipolar disorder.   "
187234|NCT00296296|"     Protocol Title: Randomized open label study comparing the metabolic control of first Kidney     Transplant recipients with Type 2 Diabetes Mellitus (DM) receiving either Prograf or Neoral     as part of a ATG induction, prednisone free and blood monitored Cellcept immunosuppressive     regimen.      PURPOSE This is a single center medical research study to analyze post-transplant kidney     recipients with pre-existing type 2 diabetes managed according to the recommended American     Diabetes Association (ADA) guidelines. Prograf (Tac) and Neoral (CSA) are the two main     medications to prevent rejection after transplantation. However, they may contribute to     poorer diabetes control. The purpose of the study is to compare the effects of Prograf and     Neoral on the control of Diabetes after kidney transplantation. In addition, all participants     in this study will receive Thymoglobulin (anti-lymphocyte globulin) at the time of     transplantation instead of long term prednisone (steroids).   "
187235|NCT00296309|"     Primary objective of this study is to compare the renal function as well as the incidence of     renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary     Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal     transplanted patients.   "
187236|NCT00296322|"     This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with     early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine     compared to mitomycin plus doxifluridine in resected advanced gastric cancer.   "
187237|NCT00296335|"     This is a phase III randomized study designed to evaluate the efficacy of mitomycin,     doxifluridine, and cisplatin compared to mitomycin and doxifluridine.   "
187238|NCT00296348|"     The primary objective of this study is to investigate the impact of early corticosteroid     withdrawal in paediatric renal transplant patients on growth expressed as change in height     standard deviation score (SDS) from baseline to end of study as the primary endpoint. The     expected advantages are reduced growth suppression, lower incidence of arterial hypertension     and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by     lower serum lipid values.   "
187239|NCT00296361|"     Primary objective of this study is to compare the two therapy regimens with regard to renal     function by using calculated creatinine clearance. The secondary objectives are to compare     the efficacy and safety profiles of the two therapy regimens.   "
187240|NCT00296374|"     The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor)     atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes     with moderate proteinuria and hypercholesterolaemia.   "
187241|NCT00296387|"     The purpose of this study is to see if rosuvastatin compared to Atorvastatin is effective in     treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following     the onset of the first symptoms is beneficial compared to placebo.   "
187242|NCT00296400|"     The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor)     atorvastatin on urinary protein excretion over 1 year in non-diabetes with moderate     proteinuria and hypercholesterolaemia.   "
187243|NCT00296413|"     Some antiseizure medication levels are affected by hormones. This study is being done to     determine if blood levels of lamotrigine or valproate are affected by the hormones in the     birth control pill or the menstrual cycle itself.   "
187275|NCT00288652|"     The purpose of this study is to determine the effectiveness of different doses of     [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection   "
187244|NCT00296426|"     An incomplete understanding of patients' preadmission medications and failure to reconcile     these with medications ordered in the hospital and at discharge are major, previously     unappreciated, causes of adverse drug events (ADEs). The Joint Commission for Accreditation     of Healthcare Organizations has now mandated a process for reconciling all medications at     hospital admission and discharge. The best ways to implement medication reconciliation and     the impact on patient outcomes are unknown. We, the researchers at at Brigham and Women's     Hospital, will design and implement a medication reconciliation process with two major     components: 1) information technology to integrate medication reconciliation into the current     workflow at Brigham and Women's Hospital (BWH); and 2) process re-design involving     physicians, nurses, and pharmacists to ensure that reconciliation takes place. We will then     conduct a randomized controlled trial on the General Medical Service of BWH to evaluate the     effects of this new process on reducing medication reconciliation errors with the potential     to cause patient harm (potential ADEs).   "
187245|NCT00296439|"     Hemodialysis patients who receive frequent weekly nutrition counseling using motivational     interviewing techniques will have lower serum phosphorus levels compared to patients     receiving standard treatment.   "
187246|NCT00296452|"     To determine if using a nutritionally enhanced supplement will improve mucositis in head and     neck cancer patients   "
187247|NCT00296465|"     This study will be performed in approximately 132 women with anovulatory/oligoovulatory     infertility.   "
187248|NCT00296478|"     This multicenter, randomized, open-label study will be performed in approximately 990 healthy     females undergoing IVF. Each study center will follow their study center standard practice     for IVF unless otherwise noted in this protocol. The study centers will be provided with the     medications for down regulation, stimulation and ovulation induction. The subjects will be     randomized to study medication on the day of oocyte retrieval or the day following and will     continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be     required to return to the clinic several times during the course of the 10 week treatment     period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.   "
187249|NCT00296491|"     This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain     clinic visits will include a physical examination, medical history review, and lung function     tests. All study related medications and medical examinations will be provided at no cost to     the subject. The drugs used in this study are approved for the age group under study.   "
187250|NCT00296504|"     GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble     and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV     versus sixteen 150mg capsules daily for APV. This study is designed to provide additional     information on long term safety and tolerability of FPV containing regimens for those     subjects who received FPV in previous GlaxoSmithKline studies.   "
187251|NCT00296517|"     This study is designed to evaluate the efficacy and safety in depressive patients who did not     respond sufficiently to selective serotonin re-uptake inhibitors (SSRI).   "
187252|NCT00296530|"     This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain     clinic visits will include a physical examination, medical history review, and lung function     tests. All study related medications and medical examinations will be provided at no cost to     the subject. The drugs used in this study are approved for the age group under study.   "
187253|NCT00296543|"     The purpose of this study is to determine if the hemodialysis procedure changes the risk for     cardiac arrest in patients.   "
187254|NCT00296556|"     The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the     treatment of mild to moderate ulcerative colitis.   "
187255|NCT00296569|"     This study is being conducted to assess the safety and tolerability of MK-0686 and to     evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.   "
187256|NCT00296582|"     This study is being done to measure the functions of the stomach after eating a meal and to     develop a new method that will simultaneously measure both gastric emptying and the     relaxation of the stomach after a meal using nuclear medicine testing. This would make the     testing more convenient for patients and will also offer better understanding of these two     gastric functions.   "
187257|NCT00296595|"     Diet has long been used as a way to provide enough nutrients to an individual in order to     meet metabolic requirements. However, recent scientific advancements have suggested that     beyond meeting nutrition needs, diet may also be health promoting through the modulation of     various body functions. In a way, the role of nutrition has evolved from hunger satisfaction     and maintenance of body integrity to the promotion of a state of well-being and prevention of     important chronic diseases such as cancer, diabetes and cardiovascular disease (CVD). In     recent years, n-3 polyunsaturated fatty acids (PUFA) have attracted much attention as     consumption of a n-3 PUFA rich diet has been reported to reduce CVD risk. However, n-3 PUFA     are also highly susceptible to free radical damage and therefore could be unable to fully     exert their health benefits under an oxidative stress condition. The general objective of the     present application is to investigate the mechanisms by which n-3 PUFA improve cardiovascular     health in abdominal obesity and explore the potential of dietary antioxidants to modulate     these effects in individuals at high risk of oxidative stress. For that purpose, we plan to     study the changes in fasting and postprandial plasma lipoprotein-lipid levels, markers of     lipid and lipoprotein oxidation, inflammation and endothelial dysfunction following 12 weeks     of n-3 PUFA supplementation with or without low-calorie cranberry juice cocktail (as a source     of antioxidants) in a group of 160 men. We feel that the present study will broaden our     understanding of the physiological mechanisms underlying the beneficial effects of consuming     unsaturated fatty acids and give further insights on the role of antioxidants in preserving     and potentiating these cardiovascular health benefits.   "
187276|NCT00288665|"     To study the effect of a simple and fast 'modus operandi' by aspiration of thrombus and     debris with the Export catheter in an acute occlusion, on microvascular (re)perfusion and     late left ventricular remodeling. Subsequently determinating if PCI with primary aspiration     as an adjunct is superior to standard PCI. Microvascular (re)perfusion will be assessed with     angiographic and electrocardiographic measurements (TIMI frame count, TIMI flow grade, Blush     score, ST-T segment measurements). Early and late left ventricular function and infarct size     will be measured with serial MRI imaging.   "
187258|NCT00296608|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     radiation therapy and chemotherapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill     any tumor cells that remain after surgery. It is not yet known whether radiation therapy is     more effective with or without chemotherapy when given before surgery for rectal cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy given together with     fluorouracil and leucovorin to see how well they work compared to giving radiation therapy     alone before surgery in treating patients with stage II or stage III rectal cancer.   "
187259|NCT00296621|"     The purpose of this study is to determine whether long-term oral glutamine supplementation is     effective in improving muscle mass and function in children with Duchenne muscular dystrophy     (DMD).   "
187260|NCT00296634|"     This randomized, controlled, double-blinded, dose-ranging, Phase I-II study in 600 healthy     adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and     dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine     when given alone or combined with aluminum hydroxide. A secondary goal is to guide selection     of vaccine dosage levels for expanded Phase II trials based on reactogenicity and     immunogenicity profiles. This dose optimization will be applied to both younger and older     subject populations in subsequent studies. Subjects who meet the entry criteria for the study     will be enrolled at one of 4 study sites and will be randomized into one of 8 groups to     receive 2 doses of influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mcg of HA with or     without aluminum hydroxide adjuvant by intramuscular injection. Participants may be involved     in study related procedures for up to 8 months.   "
187261|NCT00296647|"     The information gathered in this study may help to develop more effective ways to help people     quit smoking and stay quit in the future.   "
187262|NCT00296660|"     The purpose of this study is to collect data and body fluid samples from people with acute or     established HIV infection and from HIV uninfected people. Data from this study will be used     to better understand properties of HIV, including HIV transmission and the differences     between acute and established HIV infections.   "
187263|NCT00296673|"     The purpose of this study is to determine the effects of reactive neuromuscular training on     muscular endurance test.   "
187264|NCT00296686|"     This pilot study will assess the efficacy of several sequential pharmacological treatments     for patients with Refractory Depression.   "
187265|NCT00296699|"     This is a Pilot Study to get a first indication whether Duloxetine may be effective for     depressed patients with Atypical Features.   "
187266|NCT00296712|"     Relatively drug naive patients will receive two antidepressant medications as initial     treatment.   "
187267|NCT00296725|"     Depressed patients will have hearing tests and then be treated with up to three treatments     (i.e., Fluoxetine, Imipramine and Placebo) until remitted, to see whether test results     predict specific outcomes.   "
187268|NCT00296738|"     Myocardial scintigraphy with 123I-MIBG allows for visual and semi-quantitative assessment of     sympathetic cardiac innervation using the hear to mediastinum ratio (HMR). Impaired cardiac     MIBG clearance may occur in patients with congestive heart failure (CHF). The purpose of     present study was to develop and validate a quantitative index for the assessment of cardiac     MIBG uptake kinetics using SPECT/CT for diagnosis of CHF   "
187269|NCT00296751|"     60 female that care for pain control during second stage of delivery, will choose between     epidural or systemic analgesia. Continuous ECG (3 lead)monitoring will be recorded during the     second stage for 10 minutes. 30 minutes after administration of either pain relief, a second     recording of maternal ECG will take place for 10 minutes.   "
187270|NCT00288587|"     The purpose of this study is to assess the ability of Ultrafiltration to influence the rate     of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion     pressure, in patients with NYHA class III/IV Heart Failure.   "
187271|NCT00288600|"     The use of intravenous immunoglobulin G (IVIG) therapy has been reported in     hyperbilirubinemia of Rh hemolytic disease but we don't have enough evidences for it. Human     Immunoglobulin is considered an alternative to delay the hemolytic process and consequently     reduce the number of exchange transfusions and transfusions of red cells concentrate, thus     diminishing the risk of transmitting transfusional therapies-related diseases. OBJECTIVE: To     determine the effect of IVIG in decreasing the incidence and severity of neonatal immune     hemolytic jaundice due to Rh hemolytic disease reducing the need for exchange transfusion as     a primary goal in these babies. METHODS: This will be a randomized, double blind, clinical     trial involving all newborns with risk of significant hyperbilirubinemia due to direct     Coombs-positive Rh hemolytic disease. The primary goal will be need for exchange transfusion     and others are: incidence of late anemia, kernicterus and deafness Babies were randomly     assigned into two groups: group 1 (study group) received phototherapy plus IVIG (500 mg/kg);     and group 2 (control group) received phototherapy and normal saline solution (10 ml/Kg) in     the first 6 hours of life. Exchange transfusion was carried out in any group if at any time     the bilirubin level reached 340 micromol/l (20 mg/dl) or more, or rose by 8.5 micromol/l per     h (0.5 mg/dl per h). Adverse effects will be related in two groups. Parents informed consent     will be asked in pre-natal time.   "
187272|NCT00288613|"     Purpose The purpose of this study is to compare the economical impact and clinical parameters     of short daily hemodialysis using the NxStage® System One hemodialysis device with     thrice-weekly conventional in-center dialysis using a matched cohort from the US Renal Data     System (USRDS) database.   "
187273|NCT00288626|"     The purpose of this study is to determine the effectiveness of a new treatment for multiple     sclerosis (MS), a serious disease in which the immune system attacks the brain and spinal     cord. MS can be progressive and severe and lead to significant disability. The study     treatment involves the use of high-dose chemotherapeutic drugs to suppress the immune system.     The participant's own (autologous) blood-forming (hematopoietic, CD34+) stem cells are     collected before the chemotherapy is given, and then transplanted back into the body     following treatment. Transplantation of autologous hematopoietic stem cells is required to     prevent very prolonged periods of low blood cell counts after the high-dose chemotherapy.   "
187279|NCT00288704|"     Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations     in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1).     These mutations result in the body's overproduction of interleukin-1 (IL-1), a protein that     stimulates the inflammatory process. IL-1 Trap (rilonacept) was designed to bind to the     interleukin-1 cytokine and prevent it from binding to its receptors in the body.   "
187280|NCT00288717|"     To investigate the effects of Candesartan and Telmisartan on the home blood pressure, glucose     and lipid-metabolism in the hypertensive patients with the accumulation of visceral fat by     the newly developed Tele-medicine system   "
187281|NCT00288730|"     The purpose of this study is to assess the safety and efficacy of two doses of intravenous     NATRECORÂ® hBNP (a recombinant form of the natural human peptide normally secreted by the     heart) versus placebo in the treatment of patients with symptomatic, decompressed congestive     heart failure (CHF).   "
187282|NCT00288743|"     There is a growing body of evidence in the literature regarding the adverse effects of     hyperglycemia in critically ill patients. To target and maintain better blood glucose     regulation we implemented an insulin protocol with target blood glucose levels between 81-110     mg/dL.   "
187283|NCT00288756|"     The purpose of this study is to determine if increasing the linear rise rate of injection of     x-ray contrast in the heart during left ventriculograms(part of a cardiac Catheterization     procedure) will decrease the incidence of arrythmias and improve image quality?   "
187284|NCT00288769|"     Background:      Recurrent aphthous stomatitis is a common phenomenon in Primary Medicine.Frequency of the     phenomenon can be as high as 25% of the general population and the recurrence of the problem     can be up to 50%.Different approaches for treatment are described: treatment with various     natural vitamins , local ointments , disinfectant agents for local treatment , local     antibiotic ointments , NSAID, local cortisone-steroids , and even medication on the basis of     immune-depressants of the immune system and systematic steroids .      Methods:      A double-blind study of daily administration of sublingual Vitamin B12 tablets manufactured     by Solgar (each tablet containing 1000 mcg. of Vitamin B12) opposed to placebo tablets.      Purpose of the research:      To investigate the effect of Vitamin B12 on the frequency of recurrent canker sores of the     mouth (RAS).      Study hypothesis:      Treatment with vitamin B12 will reduce the recurrence rate and will diminish the     symptomatology of RAS episodes.   "
187285|NCT00288782|"     Recent studies show that 25 – 30% of depressed patients never fully recover, resulting in a     treatment-resistant condition. Thus, depression is a major cause of human suffering. We are     interested in finding new ways of identifying and alleviating treatment-resistant depression,     and we believe that recent advances in brain imaging can contribute to achieving that goal.     In this project, we will use a novel compound ([N-methyl-11C]mirtazapine) that we invented     for examining the neurochemistry of brain receptors involved in antidepressant actions.      Our compound, [N-methyl-11C]mirtazapine, is closely related to the clinically effective     antidepressant drug mirtazapine (Remeron®). It labels several types of noradrenergic     receptors that have often been implicated in “stress reactions” as well as depressive     disorders. We believe that our compound can identify specific molecular brain dysfunctions     that are causally related to treatment-resistant depression.      The purpose of this study is to determine whether there is a reliable relationship between     the level of mirtazapine in the bloodstream and the occupancy of neuroreceptors by     mirtazapine in the brain. We will apply our standard procedures of PET brain scanning and     region-of-interest data analysis, using healthy volunteers who will receive a daily dose of     mirtazapine (double-blind design with placebo, 7.5 mg or 15 mg daily for 5 days). We believe     that this project could provide a procedure for assessing brain function in     treatment-resistant depression, with the aim of improving the guidelines for successful,     evidence-based treatment of depression.   "
187286|NCT00288795|"     This research study is being conducted to compare the effectiveness of two types of     complimentary medicine treatments to see if they will reduce the fatigue experienced by     breast cancer patients receiving radiation therapy. The treatments being studied are Polarity     Therapy and Massage Therapy.      The primary study hypothesis is that Polarity Therapy will be efficacious in relieving     fatigue in breast cancer patients receiving radiation treatments.      The secondary hypothesis is that Polarity Therapy will be efficacious in improving     health-related quality of life in breast cancer patients receiving radiation treatments.   "
187287|NCT00288808|"     Investigate the validity of Hemosense System in pediatric patients on anticoagulation     therapy.   "
187288|NCT00288821|"     The purpose of the study is to determine the diagnostic accuracy of a new magnetic resonance     imaging (MRI) technique, the diffusion weighted imaging with body background signal     suppression (DWIBS) in the detection of lymph node pathology in patients with gynaecologic     malignancies.   "
187289|NCT00288834|"     This project proposes to evaluate the relative effectiveness of four therapy protocols for     pharyngeal phase swallowing impairment in the stroke population. Data derived from this study     should contribute significantly to our understanding of the rehabilitative process in the     neurogenic dysphagic population and will provide the foundation for the establishment of     efficacious, cost-efficient patient services.      1. Research Question to be addressed        1. The utilization of SEMG biofeedback monitoring in dysphagia rehabilitation facilitates          more rapid and complete recovery than traditional rehabilitation using the same          swallowing exercises without exteroceptive feedback.        2. Swallowing rehabilitation provided in an intensive rehabilitative programme (10 hrs of          treatment in the 1st week) facilitates more rapid and complete recovery than          traditionally scheduled swallowing rehabilitation (twice weekly).   "
187402|NCT00290316|"     The diagnostic accuracy of EUS for detection of the liver tumors (primary and metastatic)     remains unknown. To compare the accuracy of the EUS and CT scan for detection of the primary     and metastatic carcinoma of the liver.   "
187299|NCT00288964|"     A new artificial lung device has been developed that potentially provides added support to     mechanical ventilation for severely damaged lungs. The Hattler Respiratory Assist Catheter is     designed to provide gas exchange (deliver oxygen and remove carbon dioxide) for a period of     up to 7 days, providing more time for the lungs to improve.      Extrapolating from large animal data, the hypothesis is that the Hattler Catheter will be     capable of providing 30% to 40% of the basal requirements of carbon dioxide exchange in a     manner that is dependable and reproducible.   "
187290|NCT00288847|"     The activation of the knee extensors in adults after patella dislocation.      The kneecap can dislocate due to an accident or also only due to an interior turn in the     stretched knee joint out of its sliding bearing. E. Arendt (Arendt 2002) wrote an overview     work, in which possible causes and working methods to the patella dislocation are discussed.     Despite almost one hundred quotations the authors are not able find the causes and the     possible treatment concepts. The study will examined healthy adults (25 female and 25 men)     and 25 patients with patella dislocation by a routine applied clinical gait analysis and     surface EMG (after the European SENIAM guidelines) iin the Laboratory for Gait Analysis Basel     of the Children's University Hospital Basel. The combination of gait analysis and the surface     EMG with Wavelet analysis may objectify possible reasons for a patella dislocation   "
187291|NCT00288860|"     The purpose of this study is to test whether providing PTSD patients additional support by     telephone (in addition to usual outpatient care) after they discharge from residential     treatment improves those patients' outcomes and keeps them out of the hospital longer.   "
187292|NCT00288873|"     Obese persons are known to have elevated levels of parathyroid hormone (PTH) and low levels     of vitamin D. These hormones are important in regulation of the body’s calcium stores and     bone health. We would like to investigate these abnormalities and the accuracy of our current     diagnostic tests by comparing results of standard assays for vitamin D and PTH to more     specific tests, in obese subjects at baseline and as vitamin D is replaced. We will also     compare two standard vitamin D replacement regimens to determine if one is more effective.      This is a pilot study with two parts: Part 1 will compare levels of PTH and vitamin D using     two different assays in obese subjects who have normal vitamin D and those who do not. We     plan to enroll 20 subjects who have normal vitamin D levels and 40 subjects who have vitamin     D insufficiency. All subjects will fill out questionnaires about the amount of calcium and     vitamin D in their diet, and their recent sunlight exposure. We will ask for blood samples so     that we can measure levels of calcium, vitamin D, albumin, creatinine, glucose, insulin and     the different forms of PTH.      Subjects who have vitamin D insufficiency will then be randomized to receive Vitamin D2 or     Vitamin D3 in standard doses for eight weeks, in an open label trial. At four and eight     weeks, these subjects will fill out the above questionnaires and have the blood tests     repeated. For safety purposes, urine calcium will also be monitored.   "
187293|NCT00288886|"     The Contracts, Prompts, and Social Reinforcement (CPR) intervention was designed to address     the continuing care adherence needs of veterans presenting for substance use disorder (SUD)     treatment. Final results of our recently completed HSR&D clinical trial suggest CPR     meaningfully impacts aftercare adherence and abstinence rates. However, CPR did not impact     abstinence rates at earlier follow-up points, other important measures of treatment outcome,     or AA/NA support group attendance. Furthermore, the generalizability of CPR to other sites     has not been established. Thus, the intervention has been modified and pilot testing of this     improved version of CPR, which includes contingent reinforcement of abstinence and improved     prompting of AA/NA attendance (CPR+), shows promising results. We are conducting a multi-site     randomized clinical trial to examine the effectiveness of CPR+. We recruited 183 veterans     seeking residential treatment at the Salem and Jackson VAMCs. Our primary hypothesis is that     the CPR group will have higher 1-year abstinence rates compared to the STX group. Our     secondary hypotheses are that the CPR will be particularly effective for individuals with     co-morbid psychiatric disorders, and that the CPR+ group will remain in AA/NA and in     aftercare for a longer duration, have fewer days of substance use, fewer hospitalizations,     and lower costs of care. Treatment outcome will be measured 3-, 6-, and 12-months after     participants enter treatment and compared to baseline levels. The current study will seek to     extend past findings to show longer-term effectiveness of the CPR+ intervention on continuing     care adherence and greater impact on treatment outcome. Dissemination and implementation     efforts will be ongoing for this brief, inexpensive intervention, which offers an important     means to improve participation and outcome for individuals seeking SUD treatment within the     VAMC. Data collection and analysis has been completed.   "
187294|NCT00288899|"     This is a VA Merit Review Study involving 7 VA medical centers participating in a parallel     group randomized trial comparing repeat back versus standard electronic consent for 4     common elective surgical procedures (total hip arthroplasty, carotid endarterectomy,     laparoscopic cholecystectomy, and radical prostatectomy). Baseline covariates include health     status (SF-12), reading ability (REALM), and demographics. Primary outcomes are patient     comprehension of the informed consent, patient satisfaction with the informed consent and     decision making processes, patient satisfaction with care, anxiety (STAI), and provider     assessment of the repeat back process. In addition, we are electronically capturing data     detailing time spent in each phase of the consent process including repeat back.   "
187295|NCT00288912|"     The purpose of this study is to examine whether a telephone-based self-management     intervention improves pain, physical function, and other outcomes among veterans with     osteoarthritis of the hip or knee.   "
187296|NCT00288925|"     To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects     with unresectable advanced pancreatic cancer in order to determine the optimal dosage for     PhaseII study   "
187297|NCT00288938|"     Background:        -  Melanocytic nevi, or moles, are non-cancerous growths of a type of skin cell called a          melanocyte.        -  Large congenital melanocytic nevi (LCMN) are a special type of mole that begins to grow          before birth and is larger than moles that develop after birth.        -  Determining how melanocytes in moles and LCMNs differ from normal melanocytes may          increase the ability to predict whether a mole will give rise to a melanoma (a type of          skin cancer)      Objectives:        -  To understand how melanomas develop, by studying moles, LCMNs, and pigmented skin          lesions that are suspicious for melanoma        -  To develop better criteria for diagnosing melanoma, particularly by using a device          called a digital dermatoscope (a special camera, connected to a computer, that takes          pictures of moles when they are magnified and illuminated)      Eligibility:        -  Children 5 years old or older with an LCMN        -  Adults 18 years old or older with 100 or more moles larger than 2 mm in diameter and at          least one 4 mm or more        -  Adults 18 years old or older with a pigmented lesion suspicious for melanoma      Design:        -  Patients' personal and family health history is obtained.        -  Patients are examined by investigative team doctors, and several lesions are examined          with a dermatoscope.        -  Additional photographs of part or all of the skin surface may be taken.        -  Some lesions may be biopsied.        -  Additional tests or examinations may be recommended.        -  Patients are followed periodically for skin or physical examinations, photography,          laboratory and imaging evaluations, and possible skin biopsies.        -  Children may undergo brain magnetic resonance imaging (MRI)   "
187298|NCT00288951|"     The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma     therapy in patients with open-angle glaucoma or ocular hypertension   "
187302|NCT00289003|"     The purpose of this study is to explore the protective effect and safety of soluble     beta-1,3/1,6-glucan compared to placebo in oral mucositis in head and neck patients receiving     radiotherapy or chemoradiotherapy.      Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities prevent     oral mucositis   "
187303|NCT00289016|"     The primary objective of the study was to assess the clinical efficacy of talimogene     laherparepvec in terms of tumor response rates.   "
187304|NCT00289029|"     The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity     following the administration of Isovue or Visipaque in patients with moderate to severe renal     insufficiency undergoing cardiac angiography. Serum creatinine will be measured before and up     to 48-72 hours after the administration of the contrast agent to evaluate renal function.   "
187305|NCT00289042|"     SPECIFIC AIM: To test the safety and feasibility of using low molecular weight heparin (LMWH,     enoxaparin sodium; Lovenox, Sanofi-Aventis) in lieu of unfractionated heparin (UFH) as     antithrombotic therapy for patients in atrial fibrillation undergoing transesophageal     echocardiography (TEE) guided chemical or electrical cardioversion to sinus rhythm.      HYPOTHESIS: Early cardioversion from atrial fibrillation can be safely performed using a     short-term anticoagulation strategy of low molecular weight heparin (Lovenox, Sanofi-Aventis)     compared to unfractionated heparin, accompanied by a TEE examination prior to cardioversion.     The use of LMWH with TEE will result in a safe, cost-effective, and possible efficacious     approach to cardioversion of atrial fibrillation compared to UFH with TEE.   "
187306|NCT00289055|"     The main objective of this study is to assess the patency rate of the nitinol self-expandable     stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to     angioplasty only.   "
187307|NCT00289068|"     Incision size in cataract surgery is related to induced surgical astigmatism, chamber     stability, and surgical efficiency. Sleeves of different diameters change the size of the     surgical incision and amount of fluid allowed into the eye during the surgical procedure for     a given set of surgical parameters. Optimization of surgical parameters requires review of     surgical efficiency including: fluid usage, energy usage, and total surgical time. With     optimized surgical parameters recommendations can be made to increase the efficiency and     safety of cataract surgery.   "
187308|NCT00289081|"     The purpose of the study is to evaluate the clinical performance of the cruciate ligament     retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs.     Outcome scoring and radiographic assessment will be the methods used to evaluate performance.   "
187309|NCT00289094|"     The purpose of this study is to evaluate the clinical performance of the rotating platform     and fixed bearing implants in patients undergoing primary total knee replacement. Outcome     scoring and radiographic assessment will be the methods used to evaluate performance.   "
187310|NCT00289107|"     The study will evaluate the clinical performance of the rotating platform and fixed bearing     implants through patient questionnaires, outcomes scoring and radiographic assessment.   "
187311|NCT00289120|"     Examine the effects of cola on risks of kidney stones   "
187312|NCT00289133|"     The purpose of this study is to evaluate long-term clinical and radiographic data between     geometrically identical GVF and cross-linked polyethylene-bearing inserts in total knee     arthroplasty.   "
187313|NCT00289146|"     Examine the effects of renal surgery on the immune system.   "
187314|NCT00289159|"     To determine wether multimodal MRI (conventinal T1 and T2 sequences, diffusion, magnetization     transfer, spectroscopy) is reproducible; to follow up a cohort of patients with early     remmittent MS after treatment with interferon.   "
187315|NCT00289172|"     Rotavirus disease is the most common cause of gastroenteritis and dehydration in young     children worldwide. The global public health burden has prompted the development of a human     rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This     pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety     data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of     the first dose.   "
187316|NCT00289185|"     GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a     candidate malaria vaccine GSK 257049 for the routine immunization of infants and children     living in malaria endemic areas. The vaccine would offer protection against malaria disease     due to the parasite Plasmodium falciparum. The vaccine would also provide protection against     infection with hepatitis B virus (HBV).      In order to integrate the malaria vaccine into the EPI regimen in malaria-endemic regions, a     new variant RTS,S/AS02D (0.5 mL dose) has been developed.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
187317|NCT00289198|"     The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg     once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent     subjects (12 years of age and older) with perennial allergic rhinitis (PAR).   "
187318|NCT00289211|"     The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of     acute HAE attacks.   "
187319|NCT00289224|"     The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the     oral killed bivalent cholera vaccine when administered to individual residing in a     cholera-endemic area in India.   "
187331|NCT00289380|"     1. The aim of this large scale study to survey the prevalence of nutritional risk and          malnutrition in China,Europe and USA.        2. The impact of nutritional support for the patients at nutritional risk on clinical          outcomes and cost-effectiveness      Already get the approval by Ethics Committee of Peking Union medical college and Johns     Hopkins Hospital.   "
187334|NCT00289419|"     The purpose of this study is to determine whether wound infiltration with following     single-shot bolus injection with local anesthetic and NASIDs are effective in the treatment     of postoperative pain after total hip replacement compared to continuous epidural infusion.   "
187384|NCT00290082|"     Neuroleptics are used since a long time in the management of severely agitated patients.     Loxapine is routinely used in our country, with, to our knowledge no severe adverse event     reported, in this indication.      However, recently, benzodiazepines have appeared interesting in agitated patients, with the     use of midazolam.      The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated     patients admitted in the emergency department.   "
187320|NCT00289237|"     In spite of declining trend coronary heart disease (CHD) is still a leading cause of     morbidity and mortality. Many years of epidemiological research have identified several risk     factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated     through high blood pressure, high cholesterol and fatness) and smoking. So far intervention     studies on lifestyle factors have shown disappointing results, most probably due to     insufficient interventions and methodology.      Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons     representing a well-defined population. About 13,000 are invited for a health examination and     assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three     waves over a five year period. A priori the group is divided into a high intensive and low     intensive intervention group. The remaining 48.285 individuals serve as control.      After five years all individuals who attended the base-line examination are re-invited to     assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk     of CHD and biological risk factors. The total cohort (61.301) is followed through central     registers to evaluate the effect of the intervention on use of the health care system and the     long term effect on incidence of CHD.      The status for the project is that the four waves of intervention have been performed, the     last follow-up was in March 2006.      Data collection finalized with 10 years follow-up via Central National Registries and a     questionnaire. No further follow-up is scheduled for the main purposes of the study.      Analyses as regard the primary effect (on incidence of cardiovascular diseases) and secondary     effect (on incidence of type 2 diabetes) are on-going. Analyses for a large number of spin     off project are on-going.      More than 25 Ph.d. studies and more than 200 peer-review publication have so far been     produced.      Summary of results, links to articles and theses at: www.Inter99.dk   "
187321|NCT00289250|"     Treatment of uncomplicated P.falciparum malaria with sulfadoxine-pyrimethamine (SP) is     followed by a marked increase in the density of gametocytes. To determine whether treatment     with SP enhances gametocyte carriage, we randomized asymptomatic carriers of P.falciparum to     receive SP alone, SP with a single dose of artesunate, or placebo, and followed them for 56     days to record gametocyte presence and density.   "
187322|NCT00289263|"     This is a randomized, prospective and multicenter phase III study. Two-hundred-sixty-two     (262) patients on each arm will be recruited in the study.   "
187323|NCT00289276|"     Heart failure is a progressive disease that decreases the pumping action of the heart. This     may cause a backup of fluid in the heart and may result in heart beat changes. Using very low     electrical pulses that travel across the inside of the chest cavity, thoracic fluid status     monitoring (OptiVol™) can measure the level of resistance to the electrical pulses, which     indicates the level of fluid in the chest. The purpose of this study is to collect     information related to fluid build up in the chest of subjects with heart failure.   "
187324|NCT00289289|"     The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm     pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart     and reduce symptoms (such as shortness of breath, dizziness, and others).   "
187325|NCT00289302|"     Heart failure is a progressive disease that decreases the pumping action of the heart. This     may cause a backup of fluid in the heart and may result in heart beat changes. When there are     changes in the heart beat sometimes an implantable heart device is used to control the rate     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may     be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the     upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles     through three or four leads (soft insulated wires) that are inserted through the veins to the     heart.      People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating,     may be in need of an electronic device called an implantable cardioverter defibrillator     (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it     sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If     the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to     return the heart to its normal rhythm. The InSync ICD device can change the timing of when     the left and right ventricles of the heart are paced to beat.      The purpose of this study is to monitor the long-term performance of the InSync ICD Model     7272 and the InSync Marquis 7277 systems for cardiac resynchronization therapy (CRT).   "
187326|NCT00289315|"     There is a worldwide pandemic of obesity with far-reaching consequences for the health of our     nation. Obesity is the second leading cause of preventable death in the United States.     Prevention of obesity, especially in children, has been deemed by public health policy makers     to be one of the most important objectives for our country. Obesity disproportionately     affects citizens of minority and low socioeconomic status. A consensus of opinion has formed     that the recently observed increased prevalence of obesity is caused by environmental and     behavioral factors that favor easy access to high calorie foods and sedentary behavior. This     prevention project, called LA Health, will test whether modification of these environmental     and behavioral factors can prevent inappropriate weight gain in children who are enrolled in     the fourth to sixth grades during Year 1. The primary aims of the LA Health project are to     test the efficacy of two school-based approaches for obesity prevention. The two approaches     are derived from two NIH-funded pilot studies called the HIPTeens project (a secondary     prevention program) and the Wise Mind project (a primary prevention program). The study will     test the efficacy of primary prevention alone and a combination of primary and secondary     prevention in comparison to a no-treatment control group using a cluster randomization     research design, with 18 school clusters from 9 different parishes randomly assigned to the     three treatment arms. The following parishes were selected for the project: East Carroll,     Madison, Franklin, East Feliciana, St. John, St. Helena, Pointe Coupee, Avoyelles, and Sabine     Parishes. Thus far East Carroll, East Feliciana, St. John, Pointe Coupee, and Avoyelles     Parishes have agreed to participate. We anticipate adding additional parishes in the second     year of the project.The project will collaborate with a USDE funded project, LA GEAR UP, to     test the relative efficacy obesity prevention programs for children who come from     economically disadvantaged environments. The LA GEAR UP program is designed to enhance     educational achievement. Since LA GEAR UP will be implemented in all 18 school clusters, all     of the preventions intervention arms, including no-treatment, will be combined with an     academic enhancement program. The study will span three years and will provide critical tests     of strategies that modify the child's environment as a primary prevention strategy and     provide health behavior modification via classroom instruction and internet counseling as a     secondary prevention strategy. The study will also recruit a similar (but smaller) sample of     students to measure changes in body weight relative to height, gender, and age over the same     three-year period. This observation only control group will be studied to evaluate secular     trends in changes in body weight so that body weight changes observed in the randomized trial     can be interpreted within the context of stable versus unstable population changes in body     weight. The results of this investigation will significantly impact public health policy     related to obesity prevention in rural communities, minority communities, and in children     from families that are economically disadvantaged.   "
187327|NCT00289328|"     The purpose of this study is to characterize the skeletal deficits and risk factors for     impaired skeletal development in children requiring glucocorticoid therapy.      We will compare the bone health of children treated with prednisone for nephrotic syndrome     (NS with those treated with prednisone for Crohn's Disease (CD). Childhood NS usually     responds to prednisone and is not characterized by pathologies that can impact on bone. In     contrast, CD is treated with prednisone, but is independently associated with poor growth and     maturation, nutritional deficiencies and inflammation. Due to the differences in the     diseases, this comparison will allow us to distinguish between the prednisone-related and     disease-related effects on bone in the two disease states.   "
187328|NCT00289341|"     The purpose of this study is to assess the safety and activity of a type of vaccine as immune     therapy for prostate cancer. This vaccine will be made for each participant's own immune     cells (called dendritic cells) obtained by blood donation. Dendritic cells are immune cells,     whose role is to identify foreign antigens (bacteria, viruses, or tumor cells, for example)     in the body and to activate other cells of the immune system to mount an attack on that     foreign antigen. Each participant will be randomized into either Arm 1 (experimental     treatment only) or Arm 2 (placebo first, then the experimental treatment). Participants will     be given the vaccine and three boosters as an injection. After the placebo phase, each     participant in Arm 2 will crossover to the treatment phase so that all participants will     eventually receive the experimental treatment.   "
187329|NCT00289354|"     To evaluate the effect of the combination of chromium picolinate (600 μg Cr) + biotin (2 mg)     versus placebo on glycosylated hemoglobin (HbA1c), lipid profiles (Total-C, HDL-C, LDL-C,     TGs, TG/HDL ratio, etc), and pharmacoeconomic outcomes as measured at the Baseline Visit and     90 days later at the Final Visit. Secondarily, to measure the effect of chromium picolinate     (600 μg Cr) + biotin (2 mg) versus placebo on patient quality of life, fasting and     post-prandial blood sugar levels, fasting insulin, and anti-hyperglycemic medication usage.   "
187330|NCT00289367|"     The purpose of this project is to see whether treatment with a thyroid hormone, called     triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial     fibrillation.   "
187332|NCT00289393|"     The purpose of this study is to evaluate the results of elective lumbar spinal surgery as it     relates to shifting patient expectations for outcome. Patients undergoing elective posterior     spinal surgery for degenerative conditions of the spine at SWCHSC will be evaluated.   "
187335|NCT00289432|"     INCAM-study is a multicenter, prospective, randomized controlled trial. The aim of the study     is to test the effectiveness of psychoeducative intervention when offered in hospital setting     as a component of routine breast cancer care. The hypotheses are; - that breast cancer     patients participating in psychoeducative interventions focusing on coping will experience     better health-related quality of life than those who participate in the hospital standardised     psychoeducative intervention. - that coping styles are associated with the immune system.   "
187336|NCT00289445|"     The aim of this study was to define the maximum tolerated dose (MTD) of bolus mitomycin C     (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid,     and to assess the toxicity and activity in patients with previously treated colorectal and     gastric cancer. Escalating doses of MMC starting from 6 mg m(-2) in 2 mg m(-2)-steps to a     maximum of 10 mg m(-2) were applied on days 1 and 22, given to fixed doses of 5-FU (2.600 mg     m(-2)) as 24 h infusion and folinic acid 500 mg m(-2) prior to 5-FU weekly for 6 weeks   "
187337|NCT00289458|"     The objective of this project is to determine the effect of aquatic exercise and aquatic     exercise combined with an education program on decreasing fall risk in older adults with hip     osteoarthritis. The hypothesis is that aquatic exercise will improve function, strength and     balance and the addition of the education session will enhance confidence in movement.   "
187338|NCT00289471|"     Veterans who completed GEMS-Phase 1 will be asked to participate in GEMS-Phase 2 to determine     the accuracy of methods used to assess mild memory problems. This will better help us     evaluate the screening test completed in GEMS-Phase 1. The goals are:        1. Compare the assessment of memory made at the initial visit to assessments of memory made          at the second evaluation.        2. Determine of veterans with mild memory problems have improvement or worsening of these          memory problems over time. Our long-term goal remains to optimize the quality of care          for veterans with cognitive impairment. We will also determine if patient          characteristics can be used to target case-finding, describe the current process of care          and evaluate the association between cognitive impairment and overall- and          dementia-related health care utilization and costs.   "
187339|NCT00289484|"     The purpose of this study is to determine whether augmentation of antidepressant medication     with Omega-3 polyunsaturated fatty acids increases the speed and degree of improvement for     patients with major depression   "
187340|NCT00289497|"     Foot ulcers develop in diabetics with neuropathy because of cumulative injury over the course     of several days. These patients do not feel pain, and do not recognize their foot is being     injured until a wound develops. Areas about to ulcerate become inflamed and “hot spots” can     be identified. This study’s purpose is to evaluate the effectiveness of a home infrared     temperature probe designed to forewarn patients that an area on the foot is inflamed so they     can take preventive measures. The study will evaluate the incidence of diabetic foot ulcers     among high-risk patients, evaluate the cost of home temperature monitoring compared to     standard therapy, and evaluate patient satisfaction. 180 diabetics at high-risk of having     foot complications will be randomized into 3 treatment arms: 1) standard therapy consisting     of regular foot care; 2) standard therapy plus recording of a structured foot evaluation     using a hand mirror; and 3) standard therapy plus infrared home temperature assessment to     identify “hot spots.” Device patients will measure temperatures at 6 sites on the foot each     day. When temperatures are elevated >4°F patients will contact the research nurse and     decrease activity. The primary study outcome will be incident foot ulcers and Charcot     fractures.   "
187341|NCT00289510|"     The objective of this study is to assess the safety and immunogenicity of inactivated     influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to     receive a single injection of whole virion, Vero cell derived or egg derived influenza     vaccine on Day 0. Subjects will return to the study site for safety evaluation at     predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn     at predetermined intervals to measure their immunologic response to vaccination.   "
187342|NCT00289523|"     The purpose of this study is to evaluate the potential early EEG predictors of an     individual's response to treatment with antidepressant medications.      Objectives:        -  Prospectively confirm accuracy of current EEG biomarker algorithm        -  Determine preferred clinical intervention for subjects with negative indicator        -  Identify predictors of worsening suicide ideation   "
187343|NCT00289536|"     The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial     recovery (% increase [IU/dL] per IU/kg infused) and major single-infusion pharmacokinetic     parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not     have received treatment with a factor VIII concentrate for at least 3 days. Blood samples     will be drawn within 30 minutes pre-infusion and at 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32 and 48     hours post-infusion. A washout period of at least 3 days, but no more than 30 days between     the last blood draw and the next infusion will be observed. During participation, subjects     will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII     concentrate.      A secondary objective is to investigate the relationship between pharmacokinetic parameters     at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and     von Willebrand factor antigen at baseline.   "
187344|NCT00289549|"     Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days     each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour     prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy     (28 days).   "
187345|NCT00289562|"     A Phase I/II, Multi-Center, Open-Label, Repeat-Dose Study of Forodesine Hydrochloride     Infusion in Patients with B-cell Acute Lymphoblastic Leukemia with an Option of Extended Use     of Forodesine Hydrochloride   "
187346|NCT00289575|"     The aim of this pilot study is to evaluate MBCP performance in bone regeneration after     osteonecrosis biopsy of the femur head. This technic may prevent the neck of the femur bone     weakness following the healthy area drilling, thanks to a bone reconstruction at the expense     of the biomaterial.   "
187385|NCT00290095|"     The purpose of this study is to determine Clinically important difference and Response shift     in quality of life in patients with Multiple Myeloma.   "
187386|NCT00290108|"     The aim of the present study was to investigate whether injection rate of propofol has an     influence on its maximum effect.   "
187348|NCT00289601|"     This study is a randomized, double-blind, multi-center study designed to compare differences     in rates of myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times ULN) within 24     hours following low-medium risk percutaneous coronary intervention (PCI) in aspirin or     clopidogrel non-responsive patients who are randomized to heparin with or without     eptifibatide therapy during PCI. The primary objective of this study is to determine if the     use of eptifibatide is associated with a significant difference in post-PCI myonecrosis     (measured as an elevation of CK-MB ratio ≥ 2 times upper limit of normal [ULN]) within 24     hours of low-medium risk PCI in patients who are aspirin or non-responsive as determined by     VerifyNow Aspirin and P2Y12 testing.   "
187349|NCT00289614|"     The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity     following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with     moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced     multidetector computed tomography (MDCT). Serum creatinine will be measured before and up to     48-72 hours post dose.   "
187350|NCT00289627|"     The purpose of this clinical research study is to evaluate the Best Overall Response Rate     (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III     (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this     product will also be evaluated.   "
187351|NCT00289640|"     The purpose of this clinical research study is to compare the best overall response rate     (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory,     or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of     0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.   "
187352|NCT00289653|"     Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide     levels from the levels they were before they started using the patch. Subjects will also     decrease their daily consumption of cigarettes, change how they smoke the cigarette, and will     show reduced reactivity to smoking-related cues and reduced craving.   "
187353|NCT00289666|"     This study is designed to determine the effect of continuous positive airway pressure (CPAP)     or bi-level positive airway pressure (BiPAP) on heart rate variability (HRV) in patients with     obstructive sleep apnea (OSA).   "
187354|NCT00289679|"     To evaluate the concentration of cytokines and metal ions in blod samples and biopsies from     patients undergoing a hip revision.   "
187355|NCT00289705|"     The purpose is to study whether the positive effects from obesity surgery in adults also can     be achieved when adolescent subjects are operated.      Our hypothesis is that the effects concerning weight loss, health improvement and improved     quality of life will be as good in adolescents as in adults.   "
187356|NCT00289718|"     The aim of this study is to evaluate the long-term persistence of hepatitis A and B     antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a     3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting     has been updated in order to comply with the FDA Amendment Act, Sep 2007.      This protocol posting deals with objectives & outcome measures of the extension phase at year     11 to 15.   "
187357|NCT00289731|"     The focus of this study is to evaluate how risk factors like age, gender, body mass index,     smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated     with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and     B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been     updated in order to comply with the FDA Amendment Act, Sep 2007.   "
187358|NCT00289744|"     The aim of this study is to evaluate the long-term persistence of hepatitis A and B     antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary     vaccination schedule of combined hepatitis A/hepatitis B vaccine.      This protocol posting deals with objectives & outcome measures of the extension phase at year     6 through to 10.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
187359|NCT00289757|"     The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at     11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a     2 dose vaccination schedule of hepatitis A vaccine.   "
187360|NCT00289770|"     The aim of this study is to evaluate the long-term persistence of hepatitis A and B     antibodies at Years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3     dose primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.      This protocol posting deals with objectives & outcome measures of the extension phase at Year     11-15.   "
187361|NCT00289783|"     This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and     the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving     licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy     infants at 2, 4, and 6 months of age. The study will also evaluate the safety and     immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib     conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15     months of age.   "
187362|NCT00289796|"     This study will assess immunogenicity, safety and reactogenicity of primary and booster     vaccination.   "
187363|NCT00289809|"     The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined     with ifosfamide and then the efficacy of this combination in terms of overall response rate,     time to progression and time of response   "
187364|NCT00289822|"     Impaired contractile function after a heart attack and due to coronary heart disease is a     major cause of heart failure limiting quality of life and prognosis, which cannot be     prevented even with optimal standard therapy.      The aim of the current trial is to investigate whether infusion of progenitor cells into the     coronary artery supplying the most dyskinetic left ventricular area may improve left     ventricular contractile function, compared to no cell infusion in the control group, in     patients with old (>= 3 months) myocardial infarction.   "
187383|NCT00290069|"     The main aim of this study is to compare the renal function (serum creatinine at 6 months) in     the later introduction of tacrolimus or rapamycin based in immunosuppressor regimes with     daclizumab, mycophenolate mofetil, and steroids in patients older than 50 years of age who     are the recipients of a graft from donors aged 55 years and older.   "
187365|NCT00289835|"     HYPOTHESIS        1. Sealing moderate SVG lesions with the TAXUS stent prevents SVG atherosclerosis          progression as evaluated by IVUS.        2. Sealing moderate SVG lesions with the TAXUS stent does not accelerate SVG          atherosclerosis in the angiographically non-diseased segments of the SVG as evaluated by          IVUS.      OBJECTIVES        1. To determine the effect of stenting moderate SVG lesions with the paclitaxel-eluting          stent in comparison with medical treatment on limiting SVG disease progression as          evaluated by IVUS.        2. To evaluate by IVUS the effect of stenting moderate SVG lesions with the          paclitaxel-eluting stent in comparison with medical treatment on atherosclerosis          progression in angiographically non-diseased SVGs segments.   "
187366|NCT00289848|"     This is a clinical study to determine the safety and efficacy of an investigational drug in     patients with type 2 diabetes mellitus.   "
187367|NCT00289861|"     We propose a double-blind, placebo-controlled trial to study the effectiveness and     tolerability of adding risperidone to stable yet only partially remitted patients with     schizophrenia maintained on clozapine.   "
187368|NCT00289874|"     This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma     which is also active during allergy seasons in pediatric patients with seasonal aeroallergen     sensitivity.   "
187369|NCT00289887|"     This is a 16-week study to evaluate high systolic and diastolic blood pressure following     treatment in obese, hypertensive, adult patients.   "
187370|NCT00289900|"     This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the     effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A     coadministered with simvastatin) will be superior to atorvastatin on decreasing the low     denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio     for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg     MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg     MK-0524B versus 80 mg atorvastatin.   "
187371|NCT00289913|"     This two-stage study evaluates the immunogenicity, safety, and tolerability of the     administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™     (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]) and Infanrix™ (Diphtheria     and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the     administration of VAQTA™ in healthy children 15 months of age at study entry.   "
187372|NCT00289926|"     This study is designed to evaluate the efficacy and safety of oral Dehydroepiandrosterone     (DHEA) 50mg daily, for 12 months in naturally menopausal women with low libido who are not     receiving systemic oestrogen or oestrogen- progestin therapy.      Efficacy measures for the present study are effects on sexual function, wellbeing and     menopausal symptoms. Safety measures will include endometrial assessment by transvaginal     ultrasound (TVU), vital signs, lipid profiles, general electrolytes, effects on glucose     metabolism and reports of adverse events.   "
187373|NCT00289939|"     The long-term goal of this work is to reduce the prevalence of HIV and domestic violence     among women at risk by encouraging self-protective behaviors. To obtain this goal, Multnomah     County Health Department and Oregon Department of Human Services have conducted a randomized     trial of an intervention to prevent HIV and domestic violence among women who have recent     criminal justice involvement and who are at risk for HIV infection.      Women enrolled in the study were randomly assigned to one of three study conditions:        -  Group 1: these women received information on local resources addressing HIV prevention,          domestic violence, and life stability issues; they did not receive any counseling          sessions as part of the study itself.        -  Group 2: these women received up to ten supportive counseling sessions based on the          techniques of motivational interviewing. These sessions aimed to reduce HIV risk and to          improve life stability.        -  Group 3: these women received up to ten supportive counseling sessions based on          motivational interviewing. These sessions aimed to reduce risk for HIV and domestic          violence and to improve life stability.      The primary hypotheses of this study were:        -  1. Supportive counseling (motivational interviewing) addressing HIV prevention and          increased life stability will lead to reductions of HIV risk behavior among women          enrolled in the study.        -  2. Supportive counseling (motivational interviewing) addressing domestic violence          prevention, HIV prevention, and increased life stability, will bring about reductions in          experiences of domestic violence and a reduction of HIV risk among these women.        -  3. The supportive counseling received in this study will enhance these women's          self-efficacy, self-esteem, and psychological well-being.      Women in all three experimental groups were interviewed at the beginning of the study and     again after 4, 7, and 10 months. These assessment interviews asked questions about: HIV risk;     experiences of domestic violence; and life stability issues such as education, employment,     and housing; and included biological testing for HIV and sexually transmitted diseases. Women     in Group 2 and Group 3 participated in up to 10 sessions of supportive counseling     (motivational interviewing) between the time of enrollment and the 4-month interviews.   "
187374|NCT00289952|"     The purpose of this study is to examine whether the co-administration of valproic acid     (Epival®), with highly active antiretroviral therapy (HAART) can reduce the size of HIV     latent reservoirs in infected CD4 cells.   "
187375|NCT00289965|"     This project is designed to compare college drinking interventions on outcomes and     cost-effectiveness. We plan to recruit 700 students with residence hall alcohol violations to     participate in a randomized study to evaluate 3 brief interventions: in-person brief     motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a     Web-based tutorial). Participants will be followed over 12 months to determine changes in     alcohol consumption and related problems. We will also explore which participants might     respond better to one intervention vs the others.   "
187376|NCT00289978|"     This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod     (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting     multiple sclerosis (RRMS)   "
187377|NCT00289991|"     Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who     have had a Stem Cell Transplant. The success of the end point will be measured using evidence     of Infection, drug compliance and survival.   "
187378|NCT00290004|"     The primary purpose of this study is to evaluate the safety, toxicities, dosage and response     rate for an investigational drug, motexafin gadolinium, administered to patients with chronic     lymphocytic leukemia or small lymphocytic lymphoma. The secondary purpose of this study is to     evaluate the clinical benefit rate, the time it takes for a patient's chronic lymphocytic     leukemia or small lymphocytic lymphoma to worsen, the duration of response and the time     during which patients survive without chronic lymphocytic leukemia or small lymphocytic     lymphoma worsening. Additionally, the patient's response to motexafin gadolinium will be     compared to the response of the patient's cells in a laboratory to motexafin gadolinium.   "
187379|NCT00290017|"     This Phase 3 study will compare the efficacy of talabostat plus pemetrexed to pemetrexed plus     placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy     regimen.   "
187380|NCT00290030|"     To assess the efficacy of alfuzosin 10mg OD in the management of acute urinary retention     associated with BPH.      To assess the safety of alfuzosin in this population and health care consumption.   "
187387|NCT00290121|"     The purpose of this study is to understand, with the use of functional magnetic resonance     imaging, the neural correlates involved in appetite control and the mechanism of weight gain     in patients with schizophrenia treated with atypical antipsychotics. We hypothesize that a     difference in cerebral activations between weight gaining and non-weight gaining patients     will be detected after four months of treatment with olanzapine.   "
187388|NCT00290134|"     The purpose of this study is to determine whether one or more fispemifene dose regimens are     more effective than placebo in the treatment of hypogonadism in older men.   "
187389|NCT00290147|"     The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.   "
187390|NCT00290160|"     Evaluate if early protein supplementation decreases the incidence of hyperkalemia in     Extremely Low Birth Weight Infants (babies less than 1,000 grams birth weight).   "
187391|NCT00290173|"     This is a trial comparing the efficacy of oral ritodrine in the form of sustained release     capsules for the maintenance of uterine quiescence after successfully treated episode of     threatened preterm labor.   "
187392|NCT00290186|"     The study is to evaluate the effectiveness of hyperbaric treatments and the potential     longer-term effects in children between the ages of 3 and 8 years with spastic cerebral palsy     (CP). One group will receive 100% oxygen and the other group will receive the equivalent of     21% oxygen (room air). The children will receive pre-treatment testing (baseline). After 40     experimental treatments are completed, the children will be retested at 0, 3, and 6 months to     evaluate any changes.   "
187393|NCT00290199|"     In women undergoing labor induction for membrane rupture at or near term, we are     investigating the addition of a foley catheter placed in the cervix to standard therapy     (oxytocin administration) to decrease the time from the start of the induction to delivery.   "
187394|NCT00290212|"     Study Objective: To determine whether Natto supplementation in women immediately after     menopause might prevent severe bone loss      Study population: Women 50 - 60 years, 1-5 years after menopause      Study Design: Double-blind, placebo-controlled, randomized controlled trial. A phase II     clinical trial.      Instruments Used to Measure Therapeutic Response: Lunar Prodigy DEXA bone densitometer      Study Treatment Group: Daily supplementation with Vitamin K2, NATTO      Study Control Group: Identically-looking placebo medication      Duration of treatment: 12 months      Duration of Subject Participation in Study: 12 months Assessment of Therapeutic response:     Given an expected reduction of bone mass density of - 1.1% annually in the placebo group, the     minimum clinically significant difference between the groups is 0.3 percentage points. The     trial is therefore powered to detect a reduction in annual bone mass loss of 0.3 percentage     points in the treatment group.      Numbers of Evaluable Subjects Required: 304 Maximum # Subjects 334   "
187395|NCT00290225|"     Study hypothesis: that a standardized course of Eastern practices (Breath Water Sound Course     -BWS) will significantly relieve PTSD and depression in tsunami victims. Further, that a     client-centered exposure treatment (Traumatic Incident Reduction- TIR) would provide     additional, significant relief of PTSD and depression in tsunami victims.      180 tsunami victims in Southern India will be divided into three groups: those that only     receive BWS course, those that receive the BWS course and TIR and a wait-list control. They     will be pretested with the PCL-17 (PTSD scale), the Beck Depression Inventory and the General     Health Questionaire. These scales will also be administered post-service as well as five     weeks post pre-testing and at three and six month intervals.   "
187396|NCT00290238|"     The purpose of this study is to assess the benefits of Percutaneous Neuromodulation Therapy     when compared to a reference sham treatment in the treatment of patients who have undergone     surgical intervention for chronic low back pain with or without a radiating lower extremity     pain component.   "
187397|NCT00290251|"     This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine     fibroids in pre-menopausal women.   "
187398|NCT00290264|"     The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with     treatment according to conventional best practice in adolescent and adult patients with     persistent asthma.   "
187399|NCT00290277|"     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.     Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can     lead over time to cervical cancer in women . This study will evaluate the immunogenicity and     the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.   "
187400|NCT00290290|"     Most cases of infection of clean-contaminated wounds (wounds without gross spillage of     organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore,     it is conceivable that application of an optimal antiseptic agent can reduce the rate of     surgical wound infections. This trial is to compare the impact of disinfecting the skin with     Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection     of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse     effects on the skin from either antiseptic agent and the cost-savings associated with the use     of Chloraprep vs Betadine.   "
187401|NCT00290303|"     The purpose of this study is to compare the immune response, safety and reactogenicity of     Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B     vaccine to Tritanrix™-HepB/Hiberix™ when given to healthy infants (born to mothers who do not     carry hepatitis B virus) at 6, 10 & 14 weeks of age. This study will also include a small     group of infants born to mothers who do carry hepatitis B virus; these infants will receive a     birth dose of hepatitis B vaccine and will be vaccinated with Tritanrix™ HepB/Hib-MenAC at 6,     10 & 14 weeks age.   "
187403|NCT00290329|"     GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal     Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY). This study is being conducted to     collect clinical data in the local target population in order to assess the occurrence of     rare adverse events after vaccination as per the requirement of Philippines Bureau of Food     and Drugs Directive.   "
187404|NCT00290342|"     DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of     combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been     updated in order to comply with the FDA Amendment Act, Sep 2007.   "
187405|NCT00290355|"     Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed     to assess the safety of the treatment and its ability to induce an immune response.   "
187406|NCT00290368|"     This is a non-drug, biomarker study to assess the utility of the model of repeated nasal     allergen challenges in subjects with atopic rhinitis as a method of inducing an increased     response to inhaled allergen, which will more closely resemble the responses seen during the     hayfever season.   "
187407|NCT00290381|"     This is the first proof of concept study for OC000459 and is undertaken to assess the effects     of the compound on the development of inflammatory cytokines in a model (nasal allergen     challenge model) that is validated and clinically safe and easy to conduct. OC000459 will be     compared with placebo in the study.      The study will be a randomised, double blind, placebo controlled, crossover evaluation of the     effect of OC000459 on cytokine secretion induced by nasal allergen challenge. Male subjects     with a known history of allergic rhinitis and screening positive to allergen will be     included. After dosing with OC000459 or placebo, nasal allergen challenge will be performed     and measurements made in the nasal fluids. Nasal symptom scores will also be recorded. Safety     parameters will be monitored throughout.   "
187408|NCT00290394|"     The purpose of this study was to determine the effects of rosiglitazone in normotensive type     2 diabetic patients with regard to its blood-pressure–reducing effects.   "
187409|NCT00290407|"     The purpose of this study is to determine how well subjects respond to treatment with     Rituximab plus Beta-Glucan.   "
187410|NCT00290420|"     The purpose of this study is to determine which, between weekly prophylaxis or malaria attack     treatment, both by chloroquine, is the most appropriate way to protect women and foetus from     P. vivax malaria infection during pregnancy.   "
187411|NCT00290433|"     The goal of this clinical research study is to learn if treatment with two types of     chemotherapy combinations can help to control peripheral T-cell lymphoma.   "
187412|NCT00290459|"     This proposal seeks to retain discard pieces of human gynecologic tissues and discard     ascites fluid collected during normal surgical procedures, along with corresponding blood     samples and urine, for research involving prognostic markers of disease/cancer. The specific     aims of the proposal include:        1. To collect discard pieces of benign, pre-malignant and malignant gynecologic tissues,          discard ascites fluid and, when possible, corresponding blood and urine specimens from          patients undergoing:             1. hysterectomy             2. excisions of cervical dysplasia and/or venereal warts, and             3. therapeutic excisional surgeries to remove gynecologic disease/cancer (uterine,               ovarian and lower female genital tract).             4. paracentesis for the symptomatic relief of ascites fluid accumulation (distention).        2. To collect pre-operative blood and urine from patients along with pre- operative blood          work drawn for clinical evaluation.        3. De-identify the patients from their donated tissue, blood and urine specimens by          assigning a laboratory identification number.        4. Rapidly process and store the collected specimens to preserve biological integrity.          (RNA, DNA and proteins)        5. Collect and record the patient's demographic and medical information into a research          database under the assigned lab number only.        6. Assess the specimens for prognostic markers of gynecologic disease/cancer by molecular          techniques such as DNA arrays,immunohistochemistry and ELISA.   "
187413|NCT00290472|"     Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from     dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works     in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic     lymphocytic leukemia.   "
187414|NCT00290485|"     The aim of this study is to demonstrate that the use of Gleevec in initially non-resectable     gastrointestinal stromal tumors can lead to allow complete resection in 20% of cases.   "
187415|NCT00290498|"     The overall goal of this clinical research study was to find out which of two different     chemotherapy drug combinations, R-CHOP and R-HCVAD, is more effective in treating B-cell     lymphoma.      At this point, all participants will now be assigned to the R-HCVAD arm of the study.     Researchers will study the safety and effectiveness of this drug combination.   "
187416|NCT00290511|"     The goal of this clinical research study is to learn if chemotherapy given with rituximab,     followed by Ibritumomab tiuxetan (Zevalin), and then followed by rituximab can help to     control lymphoma. The safety of this treatment schedule will also be studied.      Objectives:        1. To assess whether the time to progression for these high-risk patients can be prolonged          to a median of 36 months, compared to the historical expectation of approximately 24          months.        2. To assess the tolerance and efficacy of Y2B8 (Zevalin) after R-FND (rituximab,          fludarabine, mitoxantrone, dexamethasone) in patients with high-risk stage III-IV          follicular lymphoma        3. To assess overall response, failure-free survival, and survival of this strategy          compared to our historical experience with FND (fludarabine, mitoxantrone,          dexamethasone) alone or R-FND        4. To assess the tolerance and efficacy of maintenance therapy with rituximab.        5. To maximize the 12-month molecular remission rate for patients with high-risk stage          III-IV follicular lymphoma        6. to correlate the results of quantitative PCR assay with classical PCR and with clinical          outcome   "
187417|NCT00290524|"     This study wants to address the question of whether or not oral alimentation should be begun     early in patients following colorectal surgery compared to the classical diet which depends     on reappearance of functional intestinal transit. Early oral alimentation following     colorectal surgery may decrease hospitalisation stay duration.   "
187893|NCT00307190|"     This study will determine whether the disturbances in cholecystokinin release and gastric     emptying that occur in people with binge eating disorder are similar to those that occur in     people with bulimia nervosa.   "
187418|NCT00290537|"     The goal of this clinical research study is to learn how the drug ZD6474 affects the amount     of tumor cell death in the body and the amount of blood that can be supplied to the tumor.     The safety of ZD6474 alone and when given with chemotherapy will be studied. In addition, the     side effects and response to this treatment will also be studied.   "
187419|NCT00290550|"     This is a study to evaluate the effectiveness of an investigational drug in patients with     cancer of the lung.   "
187420|NCT00290563|"     This study is designed to investigate whether a new drug may offer safe and effective     treatment for patients with overactive bladder.   "
203149|NCT00506766|"     This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training     (PFMT) and Bladder Training (BT) in women aged 55 and older.   "
187421|NCT00290576|"     Symbiotic interaction between probiotics (Living alimentary microbials supplemental,     affecting positively host by improving intestinal microbial equilibrium (Fuller, 1989)) and     human digestive tract was amply experimented and seems to be an interesting solution to     orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic     supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group.     Nevertheless, our aim is to test clinical efficiency of two new probiotics strains.     Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21)     and safety (Adverse Events) in very premature babies.   "
187422|NCT00290589|"     Low back pain is a common symptom that functionally disables many people. When the low back     pain is accompanied by pain that shoots down the leg, it is felt to be caused by a herniated     disc. We are conducting this study to determine if a powerful anti-inflammatory agent will     decrease the pain and functional impairment that is associated with this illness.   "
187423|NCT00290602|"     The purpose of this study is to determine whether the 2mg/kg administration of     corticosteroids, in the form of methylprednisolone sodium succinate, in early phase acute     respiratory distress syndrome after thoracic surgery, will reduce the postoperative     mortality.   "
187424|NCT00290615|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Cetuximab and bevacizumab     may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving     capecitabine together with cetuximab, oxaliplatin, and bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving capecitabine together with     cetuximab, oxaliplatin, and bevacizumab works in treating patients with metastatic or     recurrent colorectal cancer that cannot be removed by surgery.   "
187425|NCT00290628|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's     immune system from rejecting the donor's stem cells. When the stem cells from a related or     unrelated donor, that do not exactly match the patient's blood, are infused into the patient     they may help the patient's bone marrow to make stem cells, red blood cells, white blood     cells, and platelets.      PURPOSE: This clinical trial is studying how well donor umbilical cord blood transplant works     in treating patients with hematologic cancer.   "
187426|NCT00290641|"     RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, and     radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the     growth of cancer cells. It also stops the patient's immune system from rejecting the donor's     stem cells. The donated stem cells may replace the patient's immune system and help destroy     any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from     a donor can also make an immune response against the body's normal cells. Giving cyclosporine     and mycophenolate mofetil after the transplant may stop this from happening.      PURPOSE: This clinical trial is studying how well giving chemotherapy together with     total-body irradiation followed by donor umbilical cord blood transplant, cyclosporine, and     mycophenolate mofetil works in treating patients with hematologic cancer.   "
187427|NCT00290654|"     RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor     to kill tumor cells. Giving internal radiation therapy using a special radiation therapy     device may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy     works in treating women with ductal carcinoma in situ.   "
187428|NCT00290667|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,     such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with combination     chemotherapy works in treating older patients with previously untreated B-cell lymphoma.   "
187429|NCT00290680|"     RATIONALE: Bortezomib and celecoxib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Giving bortezomib together with celecoxib may kill more     tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and     celecoxib in treating patients with advanced solid tumors.   "
187430|NCT00290693|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel     works in treating patients with recurrent or progressive metastatic pancreatic cancer.   "
187431|NCT00290706|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Giving gemcitabine together with bortezomib may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when     given together with gemcitabine and to see how well they work in treating patients with     relapsed or refractory B-cell or T-cell non-Hodgkin's lymphoma.   "
187443|NCT00290888|"     Surgical repair of full thickness tears of the rotator cuff is a controversial issue, with     several procedures currently being used to treat the tear. The two most common treatments at     this point in time are arthroscopic cuff repair with and without acromioplasty. However, an     arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as     one that includes acromioplasty, but without threatening the shoulder stability that is     provided by the acromion and coracoacromial ligament. This prospective study examines the     hypothesis that appropriate shoulder function can be restored through the execution of the     traditional arthroscopic cuff repair without acromioplasty.   "
187432|NCT00290719|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     gefitinib together with chemotherapy and radiation therapy before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase I/II trial is studying the side effects of gefitinib when given together     with cisplatin, irinotecan, and radiation therapy before surgery and to see how well they     work in treating patients with esophageal cancer or gastroesophageal junction cancer that can     be removed by surgery.   "
187433|NCT00290732|"     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving chemotherapy in different ways, such as into the breast ducts, may kill more     tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed.      PURPOSE: This phase I trial is studying the side effects and best dose of liposomal     doxorubicin when given before mastectomy in treating women with invasive breast cancer.   "
187434|NCT00290745|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor     cells or by lowering the amount of estrogen the body makes.      PURPOSE: This clinical trial is studying how well tamoxifen or letrozole work in treating     women with ductal carcinoma in situ.   "
187435|NCT00290758|"     This randomized phase II trial is studying how well genistein works in preventing breast     cancer in women at high risk for breast cancer. Chemoprevention is the use of certain drugs     to keep cancer from forming, growing, or coming back. The use of genistein may prevent breast     cancer in women at high risk for breast cancer.   "
187436|NCT00290771|"     This was an investigational study to assess the objective overall response (OOR) rate     (complete response [CR] + partial response [PR]) of imatinib mesylate and hydroxyurea     (hydroxycarbamide) combination therapy in patients with recurrent glioblastoma multiforme     (brain tumors). This study also evaluated the duration of tumor response (as per MacDonald     criteria), clinical benefit, progression-free survival rate at 6 and 12 months, and the     survival rate at 12 and 24 months.   "
187437|NCT00290810|"     This phase II trial is studying how well bevacizumab works in treating patients with relapsed     or refractory B-cell chronic lymphocytic leukemia. Monoclonal antibodies, such as     bevacizumab, can block cancer growth in different ways. Some block the ability of cancer     cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood     flow to the cancer.   "
187438|NCT00290823|"     The purpose of this study is to determine whether a short course of increased corticosteroid     dosing with tapered dosing decreases seizure frequency as compared to standard corticosteroid     dosing in patients with neurocysticercosis (NCC).   "
187439|NCT00290836|"     The overall objective is to compare efficacy and safety of TachoComb H versus standard     surgical treatment for the control of local bleeding in patients undergoing prostatectomy.     Specific objectives include the comparison between test treatments for intraoperative     haemostatic efficacy as well as for post-operative blood loss to be assessed by haemoglobin     and haematocrit concentration of drainage fluid.   "
187440|NCT00290849|"     The objectives of this registry are to assess the use of the thrombin-specific anticoagulant     bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In     particular, data will be collected to analyze experiences of bivalirudin use in respect to     the following objectives;        -  examine the aspects of safety and effectiveness of bivalirudin        -  gain experience regarding the characteristics of patients in bivalirudin treatment        -  evaluate the handling of bivalirudin and its practicality   "
187441|NCT00290862|"     Doctors are studying an investigational treatment to be used during the vertebroplasty     procedure when treating vertebral compression fractures (spine fractures) that may help to     reduce pain and restore mobility. If one has experienced back pain for at least 4 weeks but     not longer than 1 year, he/she may be eligible to participate.      The purpose of this protocol is to describe the methods for the clinical evaluation of     Cortoss for vertebroplasty in patients with painful osteoporotic compression fractures.      Eligible patients with painful osteoporotic compression fractures of the spine are divided     into two groups. Each enrolled patient will have the vertebroplasty procedure; however one     group of patients will have the vertebroplasty procedure using polymethylmethacrylate [PMMA]     (a Food and Drug Administration [FDA]-approved bone cement) and the other group of patients     will have the vertebroplasty procedure using a relatively new (investigational) biomaterial     called Cortoss.   "
187442|NCT00290875|"     Many thousands of trauma patients are seen in Canadian emergency departments each year. On     rare occasions, such patients have a broken neck (cervical spine fracture) but in 98 percent     of cases the xrays ordered by the doctors are normal. The total cost of inexpensive but high     volume tests such as neck x-rays adds considerably to rising health care costs. In addition,     these patients are often immobilized with uncomfortable backboards and collars for many     hours, tying up valuable space and time in our crowded emergency departments.      This research group recently developed and tested a highly accurate and reliable guideline     called the Canadian C-Spine Rule to help physicians be much more selective in their use of     neck x-rays and to minimize the period of immobilization. This research project will evaluate     the true effectiveness of the Rule when implemented with simple and inexpensive measures.     This study will involve 14,000 patients in 12 busy emergency departments across Canada.      This Canadian C-Spine Rule is designed to allow physicians to be much more selective in their     use of neck xrays without the risk of missing a fracture or dislocation of the neck and to     reduce the length of time of immobilization. Widespread use of the guideline could lead to     large savings for our health care systems without jeopardizing patients and could greatly     expedite care of trauma patients in our crowded emergency departments.   "
187633|NCT00302601|"     The purpose of this study is to        -  investigate which method and criterion for diagnosing pulmonary embolism is the best and        -  determine the relationship between blood vessel constriction and clot size in patients          developing heart failure   "
187446|NCT00290927|"     -  To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as          compared with OHA therapy.        -  To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA          therapy.        -  To evaluate the safety of HMR1964.   "
187447|NCT00290940|"     This study will compare glucose lowering with CS-917 compared to placebo after 3 months of     treatment   "
187448|NCT00290953|"     To demonstrate an increase in overall survival for patients with newly diagnosed extended     stage small cell lung cancer when treated with SR48692 versus placebo, after an initial     response (complete or partial response or stable) to first line cisplatin plus etoposide.      Primary objective: comparison of overall survival between patients in the control arm and the     meclinertant arm.      Secondary objectives: comparison of the progression free survival, the time to progression,     the clinical benefit, the quality of life, the toxicity and safety between patients in the     control arm and the meclinertant arm.   "
187449|NCT00290966|"     Phase II:      Primary objective: to select one of the 2 test arms (docetaxel with cisplatin, docetaxel with     cisplatin and 5-FU), based primarily on complete responses, to advance to a phase III     survival comparison against the CDDP + 5-FU control arm.      Secondary objective: to evaluate the quantitative and qualitative safety profile of the 2     test groups.      Phase III:      Primary objective: to detect a statistically significant increase in time to progression     (TTP) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm     (cisplatin plus 5-FU).      Main secondary objective: to detect a statistically significant increase in overall survival     (OS) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm     (cisplatin plus 5-FU).      Other secondary objectives: to compare response rates, time to treatment failure, duration of     response, safety profiles, quality of life and disease-related symptoms.Socio-economic data     will be collected in order to be able to perform an analysis by country when necessary.   "
187450|NCT00290979|"     -  To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro          in terms of the change in HbA1C from baseline to endpoint.        -  To compare the safety of HMR1964 with insulin lispro.   "
187451|NCT00290992|"     Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed     hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma     uric acid concentration.      Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP     antibodies, and pharmacokinetic parameters.   "
187452|NCT00291005|"     -  To evaluate the overall tumor response rate in subjects with metastatic hormone          refractory prostate cancer        -  To evaluate PSA (tumor marker) response rate        -  To evaluate safety   "
187453|NCT00291018|"     The objective of this clinical investigation is to compare the safety and effectiveness of     ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of     symptomatic cervical disc disease (SCDD).   "
187454|NCT00291031|"     The purpose of this study is to determine whether Imagery Rehearsal Therapy(IRT) is effective     in the reduction of the number of nightmares and the nightmare distress in a population of     patients with psychiatric disorders.   "
187455|NCT00296764|"     Angelman Syndrome (AS) is a developmental disorder that is caused by a deficiency of a     maternally transmitted gene. It is inherited at birth, and affects movement, speech, and     social demeanor. This study will gain a better understanding of the disease progression and     clinical features of AS by observing children with AS over an extended period of time.   "
187456|NCT00296777|"     The main purpose of this study is to correlate brain testing with treatment outcome.   "
187457|NCT00296790|"     A comparison of Zolpidem Tartrate Extended-Release (Ambien CR)vs. Placebo in the Treatment of     Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used Concomitantly with     Escitalopram (Lexapro - antidepressant).   "
187458|NCT00296803|"     The purpose of this study is to examine the effects of clopidogrel compared to placebo on     markers of inflammation in subjects with metabolic syndrome who are receiving background     therapy including low dose aspirin.   "
187459|NCT00296816|"     Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and     oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of     angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent     addition of bevacizumab (Avastin®).   "
187497|NCT00300768|"     The primary purpose of this study is to determine the safety and tolerability of moxidectin     in subjects infected with O. volvulus with special emphasis on Mazzotti reactions to     determine whether it is safe enough to expose a number of subjects sufficient for obtaining     statistically significant data on the safety and efficacy of moxidectin relative to     ivermectin.      Secondary objects are to determine the pharmacokinetics of moxidectin, to obtain initial     indication of the efficacy in terms of long term effect on skin microfilaria levels and an     indication of the effect on the macrofilaria that may underlie the effect on skin     microfilaria levels.   "
187498|NCT00300781|"     The purpose of this study is to learn whether neratinib is safe and effective in treating     women with advanced HER2+ (human epidermal growth factor 2) breast cancer.   "
187499|NCT00300794|"     The purpose of this study is to determine whether low-dose ketamine infusion is effective in     suppressing the symptoms of opiate withdrawal during rapid opiate antagonist induction (RAI).   "
187501|NCT00300820|"     This study will examine those who will seek and those who are most likely to benefit from     genetic counseling for psychiatric disorders. It will identify themes related to perceived     risks, benefits, and possible motivations for seeking genetic counseling among families     affected by bipolar disorder. It will then use those themes to generate a starting point for     a framework to guide further research and to improve genetics services as they are currently     practiced.      Adults with bipolar disorder and the adult siblings of people with bipolar disorder are     eligible for this study. In a 60- to 90-minute telephone interview, participants are asked     questions related to their thoughts about the causes of bipolar disorder, their experiences     with the illness, their concerns about the disorder occurring again in their families, and     their feelings about the value of discussing these issues with health care professionals.     They also are asked questions about the mental health of their close family members and their     own mental health.   "
187502|NCT00300833|"     Treating an AMI patient with ST elevation with Aggrastat in the ambulance on his or her way     to the hospital.   "
187460|NCT00296829|"     All marketed influenza vaccines are injected by the intramuscular route. This study will test     whether an influenza vaccine is effective when injected by other route than into the muscle.     In order to prove this, the amount of antibodies in the blood will be measured before and     after vaccination. In addition, the safety of both influenza vaccines will be tested by     evaluating all serious reactions occurring after vaccination. The vaccine injected in this     study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip).      Primary Objective:      To demonstrate and compare the immune response of two dosages of influenza vaccine     administered by an alternate route to the intramuscular administration of the vaccine.      Secondary Objectives:        -  To compare the immune response 21 days after vaccination between each investigational          group versus intramuscular group for each influenza strain.        -  To describe the safety profile after the vaccination in each study group        -  To describe the compliance of the two dosages of the vaccine administered by the          alternate route with the European Medicine Agency.      Observational Objectives:        -  To describe the safety profile during the 21-day period following an intramuscular          revaccination in each group and the possibility of any reaction at the first injection          site.        -  To describe the pain at the injection site with a Visual Analog Scale and the          acceptability of the injection using a questionnaire in each group.        -  To describe the leakage appearing at the injection site immediately after the alternate          route injection and to explore the relationship with immunogenicity.        -  To evaluate the cellular mediated immune response in a subset of subjects.   "
187461|NCT00296842|"     The purpose of this study is to study the effectiveness of an early psychological     intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of     children and adolescents   "
187462|NCT00296855|"     The particular aim of this study is the comparison of the diagnostic results of MRA images     upon application of Vasovist (gadofosveset), a contrast agent not yet available on the     market, with the MRA images upon application of a conventional extracellular contrast agent.     A catheter angiography, which will be performed as a routine diagnostic procedure for     vascular diseases, will serve as an evaluation standard.   "
187463|NCT00296868|"     Complex Regional Pain Syndrome or posttraumatic dystrophy is a pain syndrome which develops     after a trauma, surgery or for unknown reason. The incidence after wrist fractures varies in     literature from 2 - 37%. The female sex is involved three times as much as the male sex.     There is one study in literature which describes a prophylactic effect of vitamin C after     wrist fractures. Goal of this study is to search for a dose dependent effect of vitamin C and     to replicate these earlier findings.   "
187464|NCT00296881|"     This study is to determine whether scaling and root planning (SRP) followed by photodynamic     disinfection results in improved outcomes that persist over time in adults with chronic     periodontitis when compared with subjects with SRP alone.   "
187465|NCT00296894|"     Patients will be randomized into two groups (1/1) during one year:        -  40 mg adalimumab subcutaneously (sc) every other week        -  placebo      The effect on x-rays and clinical parameters will be evaluated.   "
187466|NCT00296907|"     The purpose of the study is to evaluate the effectiveness of a two-session brief     psychological intervention in siblings of pediatric cancer patients with regard to behavior     problems and depression.   "
187467|NCT00296920|"     Despite many available treatments, there are patients with major depression who remain     treatment refractory and chronically disabled. For these severely ill patients, several     neurosurgical procedures are available where brain lesions are made that interrupt white     matter tracts linking orbital frontal cortex to the striatum, resulting in significant     therapeutic benefit for many patients. In this study, we will test the safety and efficacy of     Deep Brain Stimulation (DBS)--a reversible method used to modulate brain activity--as an     alternative to the standard subcaudate tractotomy (SCT). The physiological consequences of     this procedure will be mapped longitudinally using positron emission tomography (PET)     measures of brain glucose metabolism. Patients will be clinically monitored for 1 year with     longitudinal psychiatric, neurological, neurosurgical, neuropsychological and PET imaging     examinations to assess treatment efficacy and side effects.   "
187468|NCT00296933|"     Major Depressive Disorder (MDD) is a serious illness associated with considerable morbidity,     risk of suicide and adverse social consequences (Montgomery et al., 1994a). Cognitive     impairment is one of the three major symptom areas of MDD. Specifically, memory impairment     and concerns are one of the most commonly reported complaints in MDD. While antidepressant     (AD) treatments vary a great deal in their propensity to cause cognitive impairment, there     remains a paucity of empirical evidence on the effects of AD treatment on neuropsychological     indices of memory functioning in non-geriatric depressed individuals. Hence, comparative     effects of various AD drugs on memory functioning remain unclear.The aim of this study is to     evaluate multiple aspects of memory functioning (short-term, working memory, verbal,     non-verbal, spatial and prospective memory) of MDD patients before and after 8 weeks of     antidepressant treatment with bupropion XL or escitalopram.   "
187469|NCT00296946|"     A phase II double blind clinical trial investigating the effects of ipratropium spray versus     placebo spray in patients with Parkinson's disease.   "
187470|NCT00296959|"     A phase II double blind trial to evaluate the effects of the AMPA, glutamte antagonist,     topiramate on levodopa-induced dyskinesia in Parkinson's disease   "
187471|NCT00296972|"     The main purpose of this study is to compare the safety, effectiveness and tolerability of     using Pegasys with Copegus in people who have both the hepatitis C virus (HCV) genotype 1 and     HIV who continue taking HAART (highly active antiretroviral therapy) to those who discontinue     taking HAART.      Canadian guidelines recommend that both HIV and HCV should not be treated at the same time as     the medications needed to treat these two diseases may interact and that which disease to     treat first is dependent on the CD4 count. In this study, the CD4 count must be over 350     cells and one must be stable on HAART before starting the study medication Pegasys in     combination with Copegus.   "
187500|NCT00300807|"     1. Evaluate the safety, tolerability, and virologic activity of escalating single (and          multiple) doses of XTL6865, a mixture (1:1) of two human monoclonal antibodies          (HCV-AbXTL68 and HCV-AbXTL65), in patients with chronic hepatitis C virus infection.        2. Assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection.   "
187472|NCT00296985|"     Patients having cardiac surgery to correct their heart disease may suffer a decline in mental     and neurologic abilities. Passage of small particles of fat, tissue waste and air bubbles to     the brain while on the heart-lung machine is thought to be one cause for decline in mental     and neurologic abilities (the function of brain) after surgery.      The purpose of this study is to determine if replacement of cardiotomy suction (one part of     the heart-lung machine) with the cell-saver (a different part of the heart-lung machine)     during surgery will help to prevent a decline in mental and neurologic abilities after     surgery. investigating 312 patients over 2 years,patients will be assigned randomly to either     cardiotomy suction or cell-saver group. Patients will be given questionnaires before surgery,     6 weeks and 1-year after surgery. These questionnaires will assess memory, attention span,     the ability to concentrate and the quality of life. Patients will also have a brief     neurologic exam (physical examination to check mental state, reflexes, strength, and balance)     before surgery, 3-5 days after surgery, 6 weeks and 1-year after surgery to determine any     changes. Cell-saver separates red blood cells from tissue waste products and fat prior to     returning blood back to the patient and may reduce the negative effects of particles of fat,     tissue waste and air bubbles have on the brain. Potential benefits of cell-saver device when     used during surgery may prevent the decrease in memory, attention span, and the ability to     concentrate resulting in improved quality of life after surgery.      Objectives: The primary aim is to determine the effect of continuous flow cell-saver on short     and long term neurocognitive function after cardiac surgery, measured by precise preoperative     and postoperative psychometric and neurologic testing. Hypothesis: The primary hypothesis:     Continuous flow cell-saver reduces postoperative neurocognitive decline following cardiac     surgery. Methodology: 312 informed and consenting patients, age > 65 years, scheduled for     coronary artery bypass graft surgery will be prospectively enrolled over a 2-year period.     Patients will be randomly allocated to either the continuous flow cell-saver or conventional     cardiotomy suction (controls). Neurological history and physical exam will be completed     preoperatively, discharge, 6-weeks and 1-year after surgery. Transcranial Doppler scanning     will be used for intraoperative monitoring of cerebral embolic load. Transesophageal     echocardiography and epiaortic scanning will be employed to account for the severity of the     aortic atheroma scores. Neurocognitive testing and quality of life assessment will be     conducted preoperatively , 6-weeks and 1-year after surgery. Significance: The utilization of     continuous flow cell-saver may reduce the negative effects of fat particles, tissue waste and     air emboli have on brain.   "
187473|NCT00297011|"     A randomized study comparing the combination of valacyclovir and temovate gel (clobetasol     gel) versus placebo for the treatment of recurrent herpes labialis (cold sores).   "
187474|NCT00297024|"     Brain tumours often have low oxygen levels, and that makes them more resistant to radiation     therapy. If patients breathe the right mixture of oxygen during treatment, radiation may work     better. In this study, patients with brain tumour will undergo a special MRI test while they     breathe different mixtures of oxygen and carbon dioxide to find out whether oxygen levels     improve in the tumor. Patients will also be asked to repeat this MRI test during the second     week of radiation therapy, as well as 3 months, 6 months and 1 year after RT. The MRI test     after RT will help us understand how the blood vessels in the normal brain are affected by     radiation.   "
187475|NCT00297037|"     Study investigating the use of pimecrolimus 1% cream for oral lichen planus   "
187476|NCT00297050|"     This study will evaluate the safety and tolerability of peramivir, a new drug to treat     influenza. The study will administer gradually increasing doses of the drug in successive     small groups of subjects to determine the optimal dose that is safe and well tolerated. It     will be studied first at a single dose and then in multiple doses. The study will also     determine how long peramivir stays in the body and how high the drug levels are in the blood.      Men and women 18 - 40 years of age who weigh at least 110 lbs. and have a body mass index     (BMI) between 19 and 32 may be eligible for this study. Candidates are screened with a     medical history, physical examination, electrocardiogram (EKG), and blood and urine tests.      Part I - Single Dose Escalation      Participants are admitted to the NIH hospital for 32 to 40 hours for a single 15-minute     intravenous infusion of peramivir or placebo (saline), followed by monitoring and evaluation.     The drug dose is increased in successive groups of eight subjects; in each group, six     subjects are given peramivir and two receive placebo. The first group receives 0.5 mg/kg of     peramivir; subsequent groups receive increasingly higher doses (1, 2, 3.5, and 5 mg/kg) as     long as the last dose was well tolerated by the preceding group. Blood samples are drawn and     subjects are monitored for vital signs (temperature, blood pressure and heart rate) and for     symptoms such as headache, nausea, shortness of breath or pain at 0.5, 1, 2, 3, 6, 9, 12, 18     and 24 hours after the drug infusion. At the 24-hour evaluation they have an EKG. If needed,     an echocardiogram (ultrasound examination of the heart) may also be done. Subjects return to     the clinic 2, 3, 7, 14, and 28 days after the infusion for a check of vital signs, review of     symptoms, blood draw, and urine sample collection. In addition, subjects are asked to collect     all their urine for the first 48 hours after the study drug infusion.      Part II - Multi-dose Escalation      Groups of 16 subjects receive an intravenous infusion of peramivir (12 subject) or placebo (4     subjects) once a day for 5 consecutive days. The first four infusions are given in the NIH     outpatient clinic. The dose of peramivir is increased in successive groups of 16 subjects as     long as the preceding dose was well tolerated. Before the infusion on day 1, subjects have a     physical examination, blood test and EKG to obtain baseline values. After the infusion, they     remain in the hospital for 6 hours. Vital signs and symptoms are c...   "
187477|NCT00297063|"     This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone     and placebo.   "
187478|NCT00297076|"     The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist     GW873140 or placebo in combination with an optimized background regimen in     treatment-experienced HIV-infected subjects with R5-tropic virus   "
187479|NCT00297089|"     To determine the efficacy of ABT-751 when administered in combination with standard     pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is     complete and the study is currently enrolling subjects in Phase 2.   "
187480|NCT00297102|"     The aim of the study is to investigate the effect of roflumilast on exacerbation rate and     pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast     will be administered orally once daily in the morning at one dose level. The study duration     will last up to 56 weeks. The study will provide further data on safety and tolerability of     roflumilast.      For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673     (toll free).   "
187481|NCT00300560|"     In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated     to receive colistin or conventional antibiotic regimen.   "
187482|NCT00300573|"     The study will compare the safety and efficacy of an investigation nucleoside analog reverse     transcriptase inhibitor (NRTI), dexelvucitabine (DFC), to an approved NRTI, lamivudine (3TC)     in HIV treatment-experienced patients who are resistant to 3 classes of antiretroviral     therapies (NRTIs, PIs and NNRTIs). Patients meeting eligibility requirements will have a new     'optimized' background regimen (OBR) selected for them by their investigator based on prior     ARV treatment history and the results of HIV genotype and phenotype tests performed during     the screening period. In addition to treatment with the new OBR, patients will be randomized     to receive treatment with either DFC or 3TC in a blinded fashion. There is a 50 percent     chance a patient will receive DFC or 3TC. Treatment in the study may continue for up to 96     weeks. Patients with an inadequate response to therapy after 16 weeks will have the option to     change their OBR and the option to switch to receive the other study medication (i.e., DFC to     3TC or 3TC to DFC).   "
187483|NCT00300586|"     The objective of this trial is to improve the duration of control disease for PS 0-1 patients     who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is     for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a     second-line chemotherapy when progression of disease is occurring. Two approaches will be     experimented in this trial in attempt to prolong progression free survival :        -  Maintenance chemotherapy with single-agent gemcitabine continued till disease          progression or toxicity.        -  Sequential treatment with erlotinib immediately given after the end of first-line          chemotherapy.   "
187634|NCT00302614|"     Investigate the role of clinical parameters in predicting the severity of obstructive sleep     apnea   "
187484|NCT00300599|"     Sleep-disordered breathing (SDB) briefly means cessation of breathing during sleep at least 5     times per hour. Sleep-disordered breathing affects 9 to 24% of the middle-aged and overall 4%     of the middle-aged males suffers from Obstructive sleep apnea syndrome (OSAS) i.e. SDB with     associated daytime sleepiness. Several major epidemiological studies have shown that SDB is     not only an independent risk factor for systemic hypertension but it is also associated with     cardiovascular complications such as heart failure, stroke, and sudden death.      The mechanisms for the linkage between Sleep-disordered breathing and cardiovascular diseases     are not fully determined but surges in sympathetic nerve activity are seen at the end of each     apneic episode accompanied by large rises in systemic arterial blood pressure (BP). The     increased levels of muscle sympathetic nerve activity are diminished by nasal continuous     positive airway pressure (CPAP) therapy. Numerous studies have found a hypercoagulable state     in terms of increased clotting factor and platelet activities, and impaired fibrinolysis in     coronary artery disease, ischaemic stroke, and sleep-disordered breathing. Common carotid     artery intima-media thickness (IMT) has been shown to correlate with traditional vascular     risk factors and may predict the likelihood of acute coronary events and stroke. Recently,     carotid artery intima-media thickness has been shown to have positive correlations with the     severity of sleep disordered breathing.      Despite robust evidence showing improvement of symptoms, cognitive function and quality of     life in patients with obstructive sleep apnea treated with nasal continuous positive airway     pressure, there are conflicting short-term data whether continuous positive airway pressure     can reduce blood pressure in patients with obstructive sleep apnea. This randomized     controlled study aims to assess the long-term effects of nasal continuous positive airway     pressure on 1) 24 hr systemic blood pressure; 2) Coagulation state; and 3) Carotid artery     intimal media thickness.   "
187485|NCT00300612|"     This 2-phase study will determine the safety of treating patients with malignant melanoma     with the genetically engineered HyperAcute-Melanoma vaccine. It will establish the proper     vaccine dose and will examine side effects and potential benefits of the treatment. The     vaccine contains killed melanoma cells containing a mouse gene that causes the production of     a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response     to the foreign substance will stimulate the immune system to attack the patient's own cancer     cells that have similar proteins without this sugar pattern, causing the tumor to remain     stable or shrink.      Patients 18 years of age or older with malignant melanoma may be eligible for this study.     Candidates will be screened with medical history and physical examination, blood tests,     urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if     needed.      Participants will receive twelve vaccinations two weeks apart from each other. The vaccines     will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase     I of the study will treat successive groups of patients with increasing numbers of the     vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase     II will look for any beneficial effects of the vaccine given at the highest dose found to be     safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine     treatment. In addition, patient follow-up visits will be scheduled every 3 months for the     remaining first year (6 months) after vaccination and then every 6 months for the next 2     years for the following tests and procedures to evaluate treatment response and side effects:      Medical history and physical examination Blood tests X-rays and various scans (nuclear     medicine/CT/MRI) FACT-G Assessment questionnaire to measure the impact of treatment on the     patient's general well-being. The questionnaire is administered before beginning treatment,     monthly during treatment, and during follow-up visits after completing the treatment. It     includes questions on the severity of cancer symptoms and the ability to perform normal     activities of daily life.   "
187486|NCT00300625|"     This study was designed to validate the San Francisco Syncope Rule. This set of rules was     derived by Quinn et. al. to help guide the treatment of patients evaluated in the Emergency     Department who had an episode of syncope (passed out) or near syncope (almost passed out). A     rule that considers patients with an abnormal ECG, a complaint of shortness of breath,     hematocrit less than 30%, systolic blood pressure less than 90 mm Hg, or a history of     congestive heart failure was shown predict with a good degree of accuracy which patients     would have an adverse event and require admission.   "
187487|NCT00300638|"     The purpose of this study is to determine whether long-term chronic alcoholism is associated     with changes in emotional functioning and brain structure and function.   "
187488|NCT00300651|"     The following study addresses the hypothesis that cognitive-behavioral interventions will be     effective in reducing positive and negative symptoms of schizophrenia under the conditions of     the German health care system. It is also hypothesized that interventions designed to reduce     delusions will reduce cognitive biases and dysfunctional self-concepts.   "
187489|NCT00300664|"     About 90% of patients with haemato-oncologic malignancy lose their body muscle mass and also     lose weight either due to chemotherapy induced nausea/vomiting or the high catabolic state     due to fever, sepsis or chemotherapy. This impacts tremendously on the days in hospital and     also on the treatment-related complications. Studies with Human Growth hormone (hGH) have     shown that it increases lean body mass in adult patients with AIDS and animal models of     cancer. At the same time, in vitro studies have shown that hGH has no effect on tumor cell     growth. This study is designed to see if the use of hGH in immunocompromised patients with     haematological malignancies prevents the loss of muscle mass and weight loss to some extent.      This will be a blinded 1:1, randomised study including 150 patients whereby the patients will     either receive hGH or a placebo. The doctors and the nurses will not know what drug the     patient is receiving. Both hGH and the placebo will be given intravenously (if patients are     receiving other intravenous antibiotics or haemopoietic support ) or subcutaneously (if     platelets are above 20 x 109/L) The treatment will start on the first day of treatment and     continue for 6 weeks.   "
187490|NCT00300677|"     To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance     doses over 3 days and compare it to the amount of voriconazole in the plasma.   "
187491|NCT00300690|"     This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE)     performs better than Dacron for above knee femoropopliteal bypass.   "
187492|NCT00300703|"     To provide the infrastructure to answer prehospital research questions posed by scientists at     academic health science centers and policy makers at multiple levels of government.   "
187493|NCT00300716|"     This study is designed to determine whether memantine is an effective treatment for memory     and cognitive problems associated with multiple sclerosis when compared to placebo.   "
187494|NCT00300729|"     The primary purpose of the study is to investigate if daily treatment with celecoxib, an     inhibitor of cyclooxygenase-2, can prolong survival in patients with advanced non-small cell     lung cancer who receive anticancer chemotherapy as their primary treatment. Secondary     endpoints of the study are: health-related quality of life, toxicity, cardiovascular events,     progression-free survival, and biological markers (VEGF, proteomics).   "
187495|NCT00300742|"     The purpose of this study is to test the feasibility of using topiramate to reduce binge     eating and drinking episodes in alcohol dependent individuals with comorbid binge eating     disorder.   "
187496|NCT00300755|"     To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5     years of age with endoscopically proven symptomatic GERD.   "
187512|NCT00300963|"     The purpose of this study is to test the safety and effectiveness of talnetant vs.     risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic     schizophrenia patients.   "
187504|NCT00300859|"     DESCRIPTION (adapted from applicant's abstract): Injury control experts suggest that     consistent SBU is the most effective means for motorists to reduce1he risk of death or     serious injury in a crash. Sadly, the SBU prevalence among Massachusetts' residents is among     the lowest in the nation. In accord with Healthy People 2010, Objective 15-19, and the CDC's     Injury Research Agenda, the investigator will test the utility of a brief intervention to     increase SBU among ED patients with self-reported SBU that IS less than always. A secondary     aim is to determine if the brief intervention is more effective among persons being treated     for a motor vehicle crash (MVC)-related injury during a teachable moment than other     non-injured ED patients receiving the same intervention. The research staff will     systematically sample ED patients, screening for SBU among eligible participants during a     3-month period. Upon obtaining verbal consent, researchers will ask participants to complete     a self-administered screening form on health and safety issues, including SBU. Patients that     screen positive, (i.e., give an answer of less than always use safety belts) on a SBU     screening question will be asked to participate in an intervention to promote health and     safety among ED patients. Participants will be reimbursed for their time, and asked to do the     following: to give written informed consent via IRB-approved forms and a HIPAA release form;     complete an intake form, and agree to a follow-up phone interview at 3 and 6 months     post-enrollment. Participants will be randomized into one of two groups: an Intervention     Group that will receive a brief intervention designed to increase SBU, and a Control Group     that will receive only standard care. Research staff will contact participants for a     follow-up phone survey at 3 and 6 months to test the hypothesis that individuals randomized     to the Intervention Group will have a higher self-reported SBU than those in the Control     Group that received only standard care. Likewise, for the secondary (exploratory) analysis,     the hypothesis is that among those treated for MVC-related trauma--and randomized to the     intervention group--will have a higher self-reported SBU than others with non MVC-related     trauma due to a greater receptivity to brief intervention techniques during the ED visit     (i.e. the teachable moment).   "
187505|NCT00300872|"     Sleep-disordered breathing (SDB) briefly means cessation of breathing during sleep at least 5     times per hour. SDB is a common disorder affecting 9 to 24% of the middle-aged and overall 4%     of the middle-aged male population suffers from the Obstructive sleep apnea syndrome (OSA)     i.e. Sleep-disordered breathing (SDB) with associated daytime sleepiness. Several major     epidemiological studies have shown that SDB is not only an independent risk factor for     hypertension but it is also strongly associated with heart failure and stroke. The mechanism     for the linkage between SDB and cardiovascular consequences is not fully determined. Vascular     endothelial growth factor (VEGF) is a soluble 34-46 kD angiogenic heparin-binding     glycoprotein. This cytokine regulates multiple endothelial cell functions including vascular     permeability and vascular tone and some data suggest that it may contribute to the     atherosclerotic process. Recent studies have shown increased plasma and serum concentrations     of Vascular endothelial growth factor (VEGF) in patients with OSA and there were correlations     between VEGF concentrations and the severity of OSA, as indexed by the minimum oxygen     saturation level and the frequency of the upper airway obstruction per hour of sleep. A     recent non-randomized study with a small sample size has shown a significant decrease in     Vascular endothelial growth factor (VEGF) concentrations in patients in whom nocturnal     hypoxia improved after 1 year of nasal continuous positive airway pressure (CPAP) therapy.      Despite robust evidence showing improvement of symptoms, cognitive function and quality of     life in obstructive sleep apnea (OSA) patients treated with nasal CPAP, there are     nevertheless conflicting data whether Continuous positive airway pressure (CPAP) can reduce     daytime blood pressure (BP) in patients with OSA. Two randomized placebo controlled studies     have shown reduction of 24-hr systolic and diastolic blood pressure (BP) in obstructive sleep     apnea (OSA) patients after 1 month of nasal continuous positive airway pressure (CPAP)     therapy while other investigators have shown no such benefit.      This randomized, sham-placebo controlled study aims to assess 1) the effect of nasal     continuous positive airway pressure (CPAP) over a period of 3 months on 24 hr blood pressure     (BP); and 2) whether any change in BP and plasma Vascular endothelial growth factor (VEGF) is     related to the baseline severity of obstructive sleep apnea (OSA) and continuous positive     airway pressure (CPAP) compliance.   "
187506|NCT00300885|"     A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel     plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.   "
187507|NCT00300898|"     The purpose of this study is to learn which of three minimally invasive procedures is the     most effective for treatment of contained lumbar disc herniation.   "
187508|NCT00300911|"     The present study aimed to evaluate the effect of rosiglitazone treatment on cardiac function     compared with metformin   "
187509|NCT00300924|"     The purpose of this study is to test an experimental drug combination of two medications     currently approved by the Food and Drug Administration (FDA) for migraine headache or other     pain. These are called rizatriptan given with acetaminophen.   "
187510|NCT00300937|"     As preeclampsia is a disease specially affecting young and primiparous women, and due to the     fact that we found previously in several studies a prevalence of 12%, to ensure a confidence     of 95% and a power of 80%, it is necessary to include a total of 190 women (95 in each arm),     therefore it is planned to recluse a total of 200 pregnant women currently attending to the     outpatients clinic at the HGOIA for pregnancy control before than week 20 of gestation.      From each one of those women the clinical research team will obtain an obstetric,     anthropometric and clinical record following the current regulations of the Ecuadorian Public     Health Ministry. All women included will be under a detailed prenatal control every 4 weeks     from week 20 of pregnancy, this will include gestational age, weight, umbilical perimeter,     uterine altitude, fetal cardiac frequency and maternal blood pressure.      In addition, in each schedule visit an urine test will be done (to discard proteinuria), also     a venous blood sample (10 ml) in heparinized tubes will be taken and immediately transported     to the Biomedical Center for centrifugation and plasma isolation. During week 20, all women     will be assigned (using a randomized numbers table) to one of the following groups: a)     intervention group, that will received two capsules of 100 mg of coenzyme Q10 twice daily up     to delivery; or b) control group, that will receive two capsules of the correspondent placebo     twice daily up to delivery. Both, active and placebo capsules will be manufactured by the     same provider (Jarrow Formulas, Los Angeles, CA, USA) to guarantee that weight, size, odor     and color are similar.      Absolutely all women participating in the study will know all contact information of the     clinical team and will be allowed to request medical care as frequent as they needed,     independently of establish obstetrical controls. Preeclampsia diagnosis will be performed     only by clinical researchers and based on a persistent high blood pressure higher than 140/90     mmHg and proteinuria higher than 300 mg/24 hours.      Coenzyme Q10 will be measured using a high performance liquid chromatography equipment (HPLC)     and the method previously described and validated by our group.      The hypothesis is that in the group receiving CoQ10 supplementation will be less cases of     preeclampsia compared to placebo.   "
187511|NCT00300950|"     The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection,     non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as     safety, and immune responses related to the injections.   "
187513|NCT00300976|"     (Intervention study) The objective of the study is to confirm the superiority of the     intensive therapy to the conventional therapy concerning the prevention of the incidence or     exacerbation of vascular complications caused by diabetes mellitus (DM) by a randomized     controlled study in patients with type 2 DM.      (Follow-up study) The objective of the follow-up study is to evaluate the long-term efficacy     of intensive versus conventional therapy in the effect on mortality and the prevention of the     incidence or exacerbation of vascular complications caused by diabetes mellitus through a     post-intervention follow-up research conducted after the multi-center, open-label, randomized     parallel-group study comparing the efficacy of intensive versus conventional therapy in type     2 diabetic patients.   "
187514|NCT00300989|"     The purpose of the investigation is to compare post-operative fracture and wound healing     using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants.   "
187515|NCT00301002|"     The purpose of this study is to determine if Alefacept is effective in the treatment of     palmar plantar pustulosis.   "
187757|NCT00305396|"     A prospective, single center, open-label, randomized trial of Thymoglobulin induction and     sirolimus, prednisone, and mycophenolate mofetil versus Thymoglobulin induction and     tacrolimus, prednisone, and mycophenolate mofetil in non-HLA identical living or deceased     donor kidney transplant recipients.   "
187516|NCT00301015|"     The purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck     Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health     workers at village level in Tanzania and how the use of rapid diagnostic test may influence     prescription of antimalarial drugs.      The hypothesis is that rapid diagnostic tests used by community health workers will reduce     the use of antimalarial drugs (Coartem; Novartis) by 30% without affecting the health     outcome.   "
187517|NCT00301028|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,     such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving more than     one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses     high-energy x-rays and other types of radiation to kill tumor cells. Giving cetuximab     together with combination chemotherapy and radiation therapy, with or without cisplatin, may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin     and paclitaxel followed by radiation therapy, with or without cisplatin, works in treating     patients with metastatic head and neck cancer.   "
187518|NCT00301041|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy in different ways may kill more tumor cells.      PURPOSE: This randomized clinical trial is studying the side effects and best way to give     radiation therapy and to see how well it works in treating patients with invasive breast     cancer.   "
187519|NCT00301054|"     A study that seeks to establish an effective way of preventing anaemia in children at the     community level using two known interventions - Iron supplementation and or antimalarial.     Children recruited into the study will be assigned to four groups. Those receiving Placebo     and Iron, those receiving Placebo and Antimalarial, those receiving Placebo and Antimalarial     and those receiving double placebo. The children will be followed up over a period of nine     months and their haemoglobin concentration, malaria parasites in their blood and their weight     and height will be assessed.   "
187520|NCT00301067|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the     drug. Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor.      PURPOSE: This phase I/II trial is studying the best dose of calcitriol, the side effects of     calcitriol when given together with temozolomide, and to see how well they work in treating     patients with metastatic stage IV melanoma.   "
187521|NCT00301080|"     D-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by     chemotherapy. It is not yet known whether D-cycloserine is more effective than a placebo in     treating peripheral neuropathy caused by chemotherapy.      This randomized, double-blind, placebo-controlled clinical trial was designed to study     D-cycloserine at 2 different doses to see how well each works compared to the other and to a     placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy.   "
187522|NCT00301093|"     RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective     immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with     imatinib mesylate may be an effective treatment for chronic myelogenous leukemia.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy     when given together with imatinib mesylate in treating patients with chronic phase chronic     myelogenous leukemia.   "
187523|NCT00301106|"     RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may     help the body build an effective immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified     virus that can make interleukin-12 in treating women with breast cancer that has spread to     the liver.   "
187524|NCT00301119|"     RATIONALE: Screening tests that use biomarkers may help doctors find tumor cells early and     plan effective treatment for lung cancer.      PURPOSE: This clinical trial is studying biomarkers in screening participants for lung     cancer.   "
187525|NCT00301145|"     RATIONALE: Varenicline tartrate may help people quit smoking by decreasing the symptoms of     nicotine withdrawal. It is not yet known whether varenicline tartrate is more effective in     helping people stop smoking when given together with a telephone-based counseling program,     and Internet-based counseling program, or both programs.      PURPOSE: This randomized clinical trial is studying how well giving varenicline tartrate     together with a telephone-based counseling program and/or an Internet-based counseling     program works in helping adults stop smoking.   "
187526|NCT00301158|"     RATIONALE: Physical activity may lower the risk of some types of cancer and other chronic     diseases.      PURPOSE: This clinical trial is studying ways to increase physical activity in urban     adolescents who attend after-school programs.   "
188371|NCT00297947|"     This study will investigate the safety and efficacy of quetiapine in sub-optimally responding     patients with DSM-IV schizophrenia using a double blind, randomized 12-week trial comparing     oral doses of 1200 mg/d to 600 mg/d of quetiapine.   "
187527|NCT00301171|"     Wheezing is a high-pitched whistling sound that is produced when air flows through narrowed     lung airways. It is a common symptom of asthma. Persistent wheezing is commonly treated with     bronchodilators and inhaled steroids; however, when wheezing is temporarily caused by a virus     or exposure to tobacco smoke, this may not be the most effective treatment. The purpose of     this study is to evaluate the cause of wheezing in infants and children and to assess the     effectiveness of inhaled steroids on improving lung function.   "
187528|NCT00301184|"     The purpose of this study is to determine the safety of and immune response to a DNA HIV     vaccine, pGA2/JS7, followed by a modified vaccinia (smallpox) HIV vaccine, MVA/HIV62, in HIV     uninfected adults.   "
187553|NCT00301509|"     To evaluate:        1. the impact of combined antiviral therapy (Peginterferon plus ribavirin) on natural          history of patients affected with HCV decompensated cirrhosis, after sustained          virological response. A controlled study.        2. safety and efficacy of antiviral therapy in this population by using a statistically          significally number of patients as controls.   "
187529|NCT00301197|"     Obesity is a major public health problem. At least 15 million American adults are obese, and     the number is rising. Childhood obesity is also increasing in prevalence and currently     affects approximately 11-22 percent of children aged 6 to 11. Childhood obesity is associated     with serious negative physical, emotional, and social consequences. Obese children are at     high risk for becoming obese as adults; 24-44 percent of obese adults were obese as children.     The risk of an obese child becoming an obese adult is especially high when at least one     parent is obese. To date, adult obesity is known to be resistant to treatment. In contrast,     promising long-term effects have been found with children who received behavioral     family-based weight loss treatment. However, even with state-of-the-science programs, a     substantial percentage of children (i.e., over 40 percent) regain all or most of the weight     lost once treatment ends. The proposed study examined the efficacy of two intervention     strategies designed to improve the long-term maintenance of weight loss in children relative     to discontinued treatment contact following an active weight loss treatment phase (no     maintenance treatment control (NTC).   "
187530|NCT00301210|"     Opioids are one of the most commonly abused drugs among individuals who seek treatment for     drug abuse. Thus, it is necessary to develop new treatments for opioid addiction. The purpose     of this trial is determine whether tramadol is effective in treating opioid dependent     individuals.   "
187531|NCT00301223|"     The objective of this study is to evaluate the efficacy, safety and tolerability for     pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the     symptoms of neuropathic pain.   "
187532|NCT00301236|"     The purpose of this study is to determine which dosages of dexmethylphenidate HCl     extended-release capsules may represent effective treatment for ADHD in children 6-12 years     of age.   "
187533|NCT00301249|"     The Family Investigation of Nephropathy and Diabetes (FIND)Study is a multi-center     consortium. The charge of the consortium is to acquire sets of families with     well-characterized diabetic nephropathy, establish a secure master FIND database, and perform     a genome scan to identify chromosomal regions linked with diabetic nephropathy.   "
187534|NCT00301262|"     Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the     same extent as it is by moderate and severe ED. This study will provide controlled clinical     data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated     with Viagra versus those treated with a placebo. With an open-label extension, this study     will also provide all study subjects the opportunity to receive the active drug treatment for     6 weeks.   "
187535|NCT00301275|"     Multiple myeloma is a disorder in which malignant plasma cells accumulate in the bone marrow.     These plasma cells produce an abnormal protein called paraprotein / M spike in the serum     which can be serially monitored to assess the response of tumour on therapy. The paraprotein     has a heavy chain which can be either IgG, IgA, IgM or IgD and a light chain which can be     either kappa or lambda.      At present, these can be assessed by serum and urine electrophoresis (SPE and UPE). These     techniques are relatively insensitive and poorly quantitative compared with other     immunoassays for tumour markers.      The potential of serum free light chain (flc) measurement as a marker for myeloma has been     recognised for some time. However, development of such assays has proved elusive, primarily     due to the difficulty in developing assays that are both convenient to use and have the     required specificity to measure flc in serum. Recently , the assay has been standardised and     is in use. Its likely that the assessment of flc might be a sensitive marker of documenting     complete remission in patients with myeloma. The aim of this study is to study the flc in     patients with myeloma in complete remission (CR) to see if patients have CR documented by     standard criteria- are the free light chains still positive and if so are they better markers     of remission. The samples will be collected and tested in batches of 60 each.   "
187536|NCT00301288|"     Patients with aggressive Non−Hodgkin−lymphoma treated at first diagnosis with chemotherapy     alone or combined chemo-radiotherapy can achieve high response rates. However, patients with     relapsed lymphoma still have a poor prognosis. High dose chemotherapy (HDCT) followed by     autologous stem cell transplantation (ASCT) is the treatment of choice for these patients. An     ASCT allows patients to receive much higher doses of chemotherapy than usual, to improve the     chances of curing the disease. The high−dose of chemotherapy destroys the cells in the     patients bone marrow and then the patients own cells from either the bone marrow or     peripheral blood are used to rescue the patient from intensive treatment. High−dose     chemotherapy with autologous stem cell (either bone marrow or peripheral blood)     transplantation is used in the treatment of Intermediate/High grade NHL with poor risk     disease and in second remission at the Royal Marsden Hospital.      The purpose of the present analysis is to determine independent prognostic factors correlated     with the long−term outcome of patients with NHL who received an ASCT between January 1991 and     June 2005. Accrual of eligible patients currently under follow−up will be performed in clinic     at the time of next appointment. All patients accrued will give informed consent to     participate in the study for retrospective case note review, after discussion with a study     investigator and after receiving a study information sheet. The results of the analysis will     be published in a peer−reviewed medical journal. This will include patients treated at the     royal Marsden Hospital only.   "
187550|NCT00301470|"     The objective of functional Uro MR is to add to an initial morphological phase, based on T2     and T1 weighted MR sequences, a sequential contrast-enhanced acquisition allowing to obtain     functional semi-quantitative parameters from time-intensity curves from ROIs placed on the     aorta, renal parenchyma and cavities. If the equivalence with the renal scintigraphy is     demonstrated, it would be possible to have both the morphological and functional approach of     an obstructed kidney in one MR examination, without exposure to diagnostic irradiation.   "
187554|NCT00301522|"     The primary objective of this study is to further evaluate the safety and effectiveness of     the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and     large vessel diameters and with multiple overlapping stents in the treatment of de novo     coronary artery lesions   "
187555|NCT00301535|"     The purpose of this study is to determine if Hemopure® will enhance tissue preservation     during Cardiopulmonary Bypass surgery.   "
187761|NCT00305448|"     This study will assess the relationship between fulvestrant dose and efficacy, and determine     the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen     receptor positive advanced breast cancer.   "
187537|NCT00301301|"     There has been considerable international /national interest in the GEM−P regimen for     treatment of patients with relapsed/refractory lymphoma. Currently, there is no accepted     standard therapy for these patients. Since the publication of our experience with this     regimen (Study with CCR ethics number 1857 closed to recruitment in July 2003:Ng M, Waters J,     Cunningham D et al, Br J Cancer 2005;92:1352−7), we have treated relapsed/refractory lymphoma     patients with this regimen and would like to undertake a retrospective review of a sub−group     of these patients with diffuse large B cell lymphoma (DLBCL).      Patients treated with GEM−P with or without Rituximab prior to March 2005 for     refractory/relapsed DLBCL will be included in the analysis. Accrual of eligible patients     currently under follow−up will be performed in clinic at the time of next appointment.      All patients accrued will give informed consent for retrospective case note review, after     discussion with a study investigator and after receiving a study information sheet. All     eligible patients identified from the pharmacy database, and will be consented at the time of     the next clinic appointment, if they are agreeable for the retrospective case note review.   "
187538|NCT00301314|"     The majority of patients with Hodgkin Lymphoma (HL)are cured with radiation therapy and/or     combination chemotherapy. However, patients who relapse after attaining a complete remission     with chemotherapy and those with primary refractory disease have a poor outcome with     conventional chemotherapy regimens. Treatment results with standard−dose second−line regimens     produce low complete remission rates and minimal survival benefit. Single institution studies     have shown better outcome after autologous stem cell transplant in this group of patients     when compared to historical controls receiving conventional treatment. In this retrospective     review, we aim to analyze outcome and determine independent prognostic factors which would     correlate with the long−term outcome of patients with HL who received an autologous stem cell     transplant in the past at the Royal Marsden Hospital Eligible patients (those on     current−follow−up) identified from the transplant database will be eligible for the study.      Accrual of eligible patients currently under follow−up will be performed in clinic at the     time of next appointment. All patients accrued will give informed consent to participate in     the study for retrospective case note review, after discussion with a study investigator and     after receiving a study information sheet. The results of the analysis will be published in a     peer−reviewed medical journal.   "
187539|NCT00301327|"     This is a multi-center, randomized, double blind, vehicle controlled, study designed to     evaluate the pediculicidal activity of Summers 5% L.A. compared to a vehicle control.   "
187540|NCT00301340|"     Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator     (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore     causing a quick-acting suffocation that will not result in the development of resistance.      The objectives of this open label study are to evaluate the efficacy and safety of home use     of two 10-minute treatments of 5% L.A. (applied one week apart).   "
187541|NCT00301353|"     Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing     products may be a potential alternative to HRT for preventing bone loss during the menopausal     transition. We investigated whether one-year consumption of isoflavone-enriched foods     affected bone mineral density, bone metabolism and hormonal status in early postmenopausal     women in a randomized double-blind, placebo controlled parallel multi-centre trial.   "
187542|NCT00301366|"     The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in     adult Alpha1-antitrypsin deficient patients.   "
187543|NCT00301379|"     This is an observational study intended to validate results of a previous study done at the     Mayo Clinic. Patients are treated with combination chemotherapy and radiation and maintained     on oral Xeloda until they can receive liver transplant. A staging laparotomy is performed     before chemoradiation in order to identify patients who will most benefit from the treatment     and to improve outcomes.   "
187544|NCT00301392|"     The purpose of this study is to evaluate the effects of pitavastatin for preventing diabetes     in a population with impaired glucose tolerance.   "
187545|NCT00301405|"     To determine the efficacy of thalidomide for treatment of the Chronic Pelvic Pain Syndrome     (CPPS).   "
187546|NCT00301418|"     This study will offer a safe treatment for patients with relapsing recurring glioblastoma     (GBM) or anaplastic astrocytoma (AA). The trial will test the hypothesis that Erlotinib     (Tarceva, OSI-774) can be safely used up to a dose of 150 mg two times a day for 12 months to     ultimately enhance survival of patients with relapsed/refractory GBM/AA. Correlation of     response to Tarceva with particular genetic alterations including epidermal growth factor     receptor variant type III (EGFRvIII) amplification and phosphatase and tensin homolog     (mutated in multiple advanced cancers 1) (PTEN) loss will be studied.   "
187547|NCT00301431|"     The purpose of this study is to determine if DVS-233 is safe and effective in the treatment     of pain and other symptoms of fibromyalgia syndrome.   "
187548|NCT00301444|"     The researchers propose to conduct a pilot study on the efficacy of mirror-box and mental     visualization treatments on phantom limb pain. The trial will last for 4 months and during     the first month, data will be gathered daily on the number of episodes of phantom limb pain,     the average length of episodes, average intensity of pain, and worst intensity of pain. In     addition, the rapidity of pain relief, the length of therapy needed to sustain long-lasting     pain relief, and whether use of these two treatment methods during rehabilitation can provide     sustained and/or permanent pain relief will be determined. Cognitive testing will also be     performed to determine the effect of limb amputation on cognition and mood with results being     compared to an on-going study of similar effects in patients with chronic (> 3 months) limb     amputation.      The inclusion of subjects with phantom limb pain in upper extremity amputations has recently     been approved.   "
187549|NCT00301457|"     The purpose of this study is to determine whether 6 years adjuvant anastrozole will improve     the disease free survival compared to 3 years adjuvant anastrozole in postmenopausal hormone     sensitive breast cancer patients, subsequent to 2-3 years tamoxifen   "
187551|NCT00301483|"     The main purpose of this study is to determine if HBOC-201 is safe and tolerable to trauma     subjects, when given to treat the inadequate supply of blood and nutrients to tissues and     organs.   "
187552|NCT00301496|"     The purpose of this study is to evaluate the product performance of a new 2-layer compression     bandage for the treatment of venous leg ulcers.   "
187556|NCT00301548|"     The role of early timing of adjuvant chemotherapy was postulated to be particularly important     for patients with endocrine non-responsive disease. The role of cytotoxicity during the     period of breast surgery itself and immediately after (perioperative chemotherapy) remained     unknown. We investigated in a randomized trial the role of perioperative chemotherapy in     patients treated with a preoperative chemotherapy for locally advanced breast cancer and     compare it to the preoperative chemotherapy without additional cytotoxic therapy during and     immediately after definitive surgery. Patients with T2-3 N0-2 M0 breast cancer, with both     estrogen receptors (ER) and progesterone receptors (PgR) expressed in less than 20% of tumor     cells, or with absence of progesterone receptors, received up to 6 courses of primary     systemic therapy with epirubicin 25 mg/m2 intravenously (i.v.) on days 1 and 2, cisplatin 60     mg/m2 i.v. on day 1, and 5-fluorouracil 200 mg/m2 i.v. daily as continuous infusion (ECF).     Patients achieving a partial or complete remission were randomized to continue the infusion     of fluorouracil until 2 weeks after surgery (perioperative treatment arm) or to stop     fluorouracil infusion one week before surgery, on day 21 of the sixth cycle (control arm).   "
187557|NCT00301561|"     Access to antiretroviral therapy (ART) is still limited in Africa (11% of patients in     immediate need in June 2005). Face to the scope of the need and the constraints     (unavailability and cost of viral load and CD4 cell count, lack of physicians…), WHO has     developed a follow-up approach based on a simplified monitoring. However, this simplified     approach which represents a major stake for the expanded access to ART has been little     evaluated against the gold standard approach.   "
187558|NCT00301574|"     The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day     and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment     of patients with Alzheimer's disease, and to investigate the dose-response.   "
187559|NCT00301587|"     The purpose of this study is to compare red blood cell folate levels in women who are taking     oral contraceptives with or without folic acid   "
187560|NCT00301600|"     A single-center random parallel study to compare the efficacy and safety of Mycophenolate     mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA     nephropathy   "
187561|NCT00301613|"     This study is performed to compare the efficacy, safety, tolerability and relapse of MMF vs     CTX in the treatment of severe HSPN   "
187562|NCT00301626|"     Background. The ROSCAP Study was a randomized controlled trial in heart disease patients to     test the effect of a smoking reduction intervention on cigarettes per day (cpd) and     biochemical and clinical indicators of tobacco exposure. .   "
187563|NCT00301639|"     The specific aim of this study is to document the pharmacokinetics of dopamine transporter     DAT receptor occupancy of OROS MPH and Metadate CD using PET scanning with C-11 Altropane as     the ligand. We hypothesize that CNS DAT occupancy of OROS MPH will be greater than that of     Metadate CD at 10 hours after administration.   "
187564|NCT00301652|"     The purpose of this study is to access the efficacy of MMF compared to CTX in inducing     remission and improving renal function in subjects with ANCA associated vasculitis with renal     involvement.   "
187565|NCT00301665|"     The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®)     injections into pericranial muscles compared to placebo to prevent migraine attacks.   "
187566|NCT00301678|"     RATIONALE: Decreasing the amount of fat in the diet and increasing fruit, vegetable, and     fiber intake may help prevent some types of cancer. Giving participants easy-to-read     personalized written nutrition materials and a personalized videotape may help improve eating     habits.      PURPOSE: This clinical trial is studying how well personalized nutrition education improves     the eating habits of healthy participants who eat an unhealthy diet.   "
187567|NCT00301691|"     RATIONALE: Decreasing the amount of fat in the diet and increasing fruit and vegetable intake     may help prevent some types of cancer. Giving low-income participants easy-to-read written     nutrition materials and an instructional and motivational videotape may help improve eating     habits.      PURPOSE: This randomized clinical trial is studying how well nutrition education improves the     eating habits of low-income healthy participants who eat an unhealthy diet.   "
187568|NCT00301730|"     RATIONALE: Biological therapy, such as cellular adoptive immunotherapy, may stimulate the     immune system in different ways and stop tumor cells from growing.      PURPOSE: This phase I trial is studying how well cellular adoptive immunotherapy works in     treating a patient who has undergone a donor stem cell transplant for breast cancer that has     spread to the lung.   "
187569|NCT00301756|"     This phase II trial studies how well belinostat works in treating patients with ovarian     epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that have spread to     other places in the body or ovarian low malignant potential tumors. Belinostat may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
187570|NCT00301769|"     This phase I trial is studying the side effects and best dose of SJG-136 in treating patients     with relapsed or refractory acute leukemia, myelodysplastic syndromes, blastic phase chronic     myelogenous leukemia, or chronic lymphocytic leukemia. Drugs used in chemotherapy, such as     SJG-136, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing.   "
187635|NCT00302627|"     Bone is lost rapidly and fractures occur in 10-20% of patients who receive organ transplants     within 2 years. The purpose of this study is to evaluate long-term effects of a     pamidronate-vitamin D-calcium regimen on bone loss, fractures, and safety in recipients of     kidney and heart transplants.   "
187571|NCT00301782|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, vincristine, bleomycin,     carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. It is not yet known which     combination chemotherapy regimen is more effective in treating germ cell tumors.      PURPOSE: This randomized phase II trial is studying two different combination chemotherapy     regimens to compare how well they work in treating male patients with germ cell tumors.   "
187639|NCT00302679|"     According to experience in a self-payed health check-up center,unsedated total colonoscopy is     not inferior or may be better than unsedated sigmoidoscopy in terms of pain and patients'     acceptance.      Hypothesis: Unsedated total colonoscopy is not inferior to unsedated sigmoidoscopy in terms     of pain and patients' acceptance.   "
187572|NCT00301795|"     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Oblimersen may help rituximab work better by     making cancer cells more sensitive to the drug. This phase II trial is studying how well     giving rituximab together with oblimersen works in treating patients with stage II, stage     III, or stage IV follicular non-Hodgkin's lymphoma   "
187573|NCT00301808|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving more than one chemotherapy drug (combination chemotherapy) together with radiation     therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium     together with radiation therapy followed by docetaxel works in treating patients with stage     III non-small cell lung cancer.   "
187574|NCT00301821|"     RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in     chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill     more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal     antibody therapy together with combination chemotherapy works in treating patients with stage     II, stage III, or stage IV diffuse large B-cell lymphoma.   "
187575|NCT00301834|"     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as fludarabine and busulfan, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. A peripheral stem cell, bone     marrow , or umbilical cord blood transplant may be able to replace blood-forming cells that     were destroyed by chemotherapy. Sometimes the transplanted cells from a donor can make an     immune response against the body's normal cells. Giving cyclosporine together with     methotrexate and methylprednisolone may stop this from happening.      PURPOSE: This phase II trial is studying how well giving alemtuzumab together with     fludarabine and busulfan works when given before donor stem cell transplant in treating young     patients with hematologic disorders.   "
187576|NCT00301847|"     This phase II trial is studying how well sorafenib works in treating patients with kidney     cancer that has spread to the brain. Sorafenib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
187577|NCT00301860|"     RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps     stop both the growth of cancer cells and the patient's immune system from rejecting the     donor's stem cells. When the healthy stem cells from a donor are infused into the patient,     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,     and platelets. Sometimes the transplanted cells from a donor can make an immune response     against the body's normal cells. Giving chemotherapy, such as fludarabine and melphalan, and     antithymocyte globulin before transplant and cyclosporine and methotrexate after transplant     may stop this from happening.      PURPOSE: This clinical trial is studying how well donor stem cell transplant, using low-dose     chemotherapy and antithymocyte globulin, followed by donor white blood cell infusions work in     treating young patients with hematologic cancer.   "
187578|NCT00301873|"     RATIONALE: Zoledronate may prevent bone loss in patients with primary malignant glioma.      PURPOSE: This phase II trial is studying how well zoledronate works in preventing     osteoporosis in patients with primary malignant glioma.   "
187579|NCT00301886|"     RATIONALE: Zoledronate and ibandronate may prevent or help relieve bone pain and other     symptoms caused by bone metastases. It is not yet known whether zoledronate is more effective     than ibandronate in preventing bone problems caused by bone metastases due to breast cancer.      PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works     compared to ibandronate in preventing bone problems in women with stage IV breast cancer that     has spread to the bone.   "
187580|NCT00301899|"     RATIONALE: Monoclonal antibodies, such as trastuzumab and pertuzumab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Giving trastuzumab     together with pertuzumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving trastuzumab together with pertuzumab     works in treating patients with unresectable locally advanced or metastatic breast cancer     that did not respond to previous trastuzumab.   "
187581|NCT00301912|"     RATIONALE: Drugs used in chemotherapy, such as busulfan and fludarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving chemotherapy with a peripheral stem cell or bone marrow transplant may allow     more chemotherapy to be given so that more cancer cells are killed. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Tacrolimus and methotrexate may stop this from happening.      PURPOSE: This phase II trial is studying how well giving busulfan together with fludarabine     before donor stem cell transplant works in treating patients with hematologic cancer.   "
187636|NCT00302640|"     The purpose of this study is to determine the effect of nitazoxanide suspension in treating     diarrhea caused by enteric viruses in children less than 12 years of age.   "
187582|NCT00301925|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy     after surgery may kill any remaining tumor cells. It is not yet known which combination     chemotherapy regimen is more effective in treating early stage breast cancer that has been     removed by surgery.      PURPOSE: This randomized phase III trial is studying four different combination chemotherapy     regimens to compare how well they work in treating patients with early stage breast cancer     that has been removed by surgery.   "
187583|NCT00301938|"     This phase I trial is studying the side effects and best dose of 7-hydroxystaurosporine when     given together with perifosine in treating patients with relapsed or refractory acute     leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes. 7-Hydroxystaurosporine     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Drugs used in chemotherapy, such as perifosine, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Giving     7-hydroxystaurosporine together with perifosine may kill more cancer cells.   "
187584|NCT00301951|"     RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant helps stop both     the growth of cancer cells and the patient's immune system from rejecting the donor's stem     cells. When the healthy stem cells from a donor are infused into the patient, they may help     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Sometimes the transplanted cells from a donor can make an immune response against the body's     normal cells. Giving chemotherapy, such as fludarabine and busulfan, and antithymocyte     globulin before transplant and tacrolimus and mycophenolate mofetil after transplant may stop     this from happening.      PURPOSE: This clinical trial is studying how well giving low-dose fludarabine and busulfan     together with anti-thymocyte globulin, followed by donor umbilical cord blood transplant     works in treating patients with advanced hematologic cancer.   "
187585|NCT00301964|"     This phase II trial is studying how well bevacizumab works in treating patients with     recurrent or persistent endometrial cancer. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.   "
187586|NCT00301990|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Interleukin-2 may stimulate the     white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with     interleukin-2 works in treating patients with metastatic kidney cancer.   "
187587|NCT00302003|"     This phase III trial is studying how well combination chemotherapy works when given before     radiation therapy and/or additional chemotherapy in treating young patients with newly     diagnosed Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug     (combination chemotherapy) and giving them together with radiation therapy may kill more     cancer cells.   "
187588|NCT00302016|"     This study will further evaluate if AMN107 is safe in adults with chronic myeloid leukemia     who are resistant or intolerant to imatinib and to provide patients access to this new drug     until the drug becomes commercially available.   "
187589|NCT00302029|"     The purpose of this study is to find out more about cytomegalovirus (CMV) and how it is     spread between people. One thousand adolescent males ages 12-17 years will participate in     this study. Participants will be given a questionnaire about risk factors for CMV. A small     blood sample (2-3 teaspoons) will be taken to test for CMV infection. Subjects that are CMV     seronegative may participate in the second part of this study, which will involve returning     to the clinic at regularly scheduled visit times to provide blood, urine, and saliva (spit)     samples. This part of the study will take at least 24 months to complete. Subjects that test     positive for CMV during the 2nd portion of the study will be invited to participate in the     3rd part of the study. This part of the study will require 8 regularly scheduled visits to     provide blood, urine and saliva samples, over a 12-month period. The maximum amount of time a     subject will participate in the study is 36 months.   "
187590|NCT00302042|"     The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention     resulting in modest weight loss and increased physical activity can delay or prevent the     development of type 2 diabetes in those at increased risk for the disease. The lifestyle     program used, however, was not designed for delivery on a public health scale. Successful     community translation of the DPP's findings will require close collaboration with an     established community organization committed to improving community health and experienced in     implementing sustainable health and wellness programs. With exceptional reach into diverse     U.S. communities, the Young Mens Christian Association (YMCA) may be an ideal community     partner. We have been collaborating with the YMCA organization for over a year to design a     robust recruitment and implementation model that is sensitive to the unique needs and     resources of a community organization. We now propose to evaluate if a group-based adaptation     of the DPP lifestyle intervention can be successfully implemented by YMCA staff, in YMCA     facilities. We have designed this study to develop preliminary data about the reach,     effectiveness, and consistent implementation of the DPP lifestyle intervention in this     context. This pilot study has two primary aims: 1) to demonstrate the extent to which YMCA     staff trained by DPP study personnel can administer a group-based adaptation of the DPP     lifestyle intervention in a fashion consistent with DPP intervention protocols, and 2) to     evaluate if the intervention program delivered by the YMCA results in changes in body mass,     physical activity, and dietary intake that are consistent with a level found to be associated     with diabetes risk reduction during the DPP trial. We will also collect valuable data about     the feasibility and reach of a selective, community-based marketing and screening approach     for recruiting program participants. In combination, these data will enable us to design and     conduct a larger, future 3-year trial focusing on the effectiveness and sustainability of     community DPP translation in multiple YMCA settings.   "
187624|NCT00302484|"     Patients with a terminal chronic liver disease have a disordered bone metabolism resulting in     a higher risk of falling ill with osteoporosis. Although liver transplantation restores liver     function, immunosuppressive therapy (especially corticosteroids) after transplantation     increases again the risk of osteoporosis and bone fragility. Zoledronate, a bisphosphonate,     slows down the destruction of bone. The purpose of this study is to determine whether     bisphosphonates are effective in the prevention of osteoporosis following immunosuppressive     therapy after liver transplantation.   "
187679|NCT00294151|"     The study aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of     spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone. The     investigators hypothesize that, by combining vertebral augmentation with cement and     radiotherapy, they could achieve an enhancement in pain relief and level of activities, as     well as a decrease in the side effects of multiple medications used for pain control.   "
187758|NCT00305409|"     The purpose of this study is to determine whether administration of a synbiotic, comprised on     inulin and a bifidobacterial probiotic will colonise the gut wall and down-regulate TNF-alpha     and other pro-inflammatory cytokines in the mucosa of Crohn's patients with active disease to     reduce mucosal inflammation and induce remission.   "
187591|NCT00302055|"     The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention     resulting in modest weight loss and increased physical activity can delay or prevent the     development of type 2 diabetes in those at increase risk for the disease. The lifestyle     program used, however, was not designed for delivery on a public health scale. Successful DPP     translation will require a sustainable partnership between a health care system and an     established community organization committed to community health and experienced in     implementing sustainable health and wellness programs. We have been collaborating with local     health system and community administrators for over a year to design a 'real-world'     clinic-based screening model to identify and refer high-risk patients for a group-based     adaptation of the DPP lifestyle intervention in community facilities. We have designed this     study to develop preliminary data about the feasibility and yield of clinic-based screening     and referral, as well as the effectiveness of the adapted lifestyle intervention. This pilot     study seeks to: 1) evaluate the feasibility of a strategy to implement American Diabetes     Association (ADA) recommendations for clinic-based diabetes-risk testing and to refer     high-risk patients for a community-based lifestyle intervention; 2) compare two strategies to     enhance community-based program participation by referred patients; 3) demonstrate the     capability of community facilities to schedule and enroll referred clinic patients at     high-risk for diabetes and to deliver a modified, group-based DPP lifestyle intervention     consistently; and 4) compare levels of weight loss and physical activity achieved by referred     clinic patients with pre-diabetes who participate in a free-of-charge, group-based DPP     lifestyle intervention at community facilities compared to a free-of-charge, traditional,     one-on-one DPP lifestyle intervention at a DPP research site. Addressing these issues now     will enable us to evaluate this partnered DPP translation model with a larger, more robust     future study that will involve referral by multiple primary care clinics, program delivery at     more community sites, and a 3-year follow-up period.   "
187592|NCT00302068|"     Some individuals with coronary heart disease (CHD) suffer from depression and use     antidepressant medications to reduce symptoms. However, preliminary research has shown that     exercise may be a more effective way to treat depression in these individuals. The purpose of     this study is to evaluate the effects of exercise in reducing depression and improving heart     function in individuals with CHD.   "
187593|NCT00302081|"     This is a randomized, open-label, multinational study designed to evaluate the standard     regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm     PEG2b 1.5/R (24 weeks)], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously     once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.0/R (24 weeks)], using a 24 week     treatment duration for both arms. Additionally, the study examined the efficacy of reduced     treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg     for 16 weeks [Arm PEG2b 1.5/R (16 weeks)] .   "
187594|NCT00302094|"     CT-examinations are used in computer programs which are used in the planning of external     radiation of cancers in the anal canal. In CT the structures of the anal canal are hardly     visible. 3D-ultrasound examinations offer a better visualisation of normal and pathological     structures of the anal canal. The description of the tumour made from the 3D-ultrasound     examination is used in the planning of the external radiation.      PET-CT is used to visualise tumour activity also in lymp nodes. The hypothesis of the study     is that image fusion of PET, CT and 3D-ultrasound will offer better visualisation of tumour     and hereby more accurate diagnostics and treatment.   "
187595|NCT00302107|"     Objective: To study the efficacy and tolerability of mirtazapine (Remeron) in the treatment     of PTSD.      Research Design: This is an 8-week randomized, double-blind, placebo-controlled treatment     trial of mirtazapine for the treatment of PTSD as defined on the Clinical Assessment of PTSD     Scale (CAPS).      Methodology: After signing an informed consent and meeting all inclusion/exclusion criteria,     the patient is randomized to either mirtazapine versus placebo for 8-week duration. During     the study a pharmacist maintains the randomization log and verifies the order for the placebo     or mirtazapine in look-a-like tablets. Patients' symptoms, side effects and compliance are     assessed bi-weekly. Based on symptomology and occurrence of side effects, the investigator     increases the medication in 15 mg increments, as tolerated, until a maximum therapeutic     benefit is achieved, not to exceed 45 mg/day. The dosing is at bedtime. Compliance is     assessed by bi-weekly pill count at week 4 and week 8. Patients are given supportive clinical     management during the clinic visits. An investigator is available by telephone 24 hrs a day     in case of emergency. Patients may be seen more often if needed. Efficacy will be measured by     the following assessment scales: Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton     Anxiety Scale (Ham-A), Clinical Global Impression Severity of Illness (CGI-s), Clinical     Global Impression of Improvement (CGI-I), Global Assessment of Functioning (GAF), CAPS,     Treatment Outcome PTSD rating scale (TOP-8), and Davidson Trauma Scale (DTS).      Clinical Significance: Mirtazapine has shown promise in treating PTSD in an open label trial.     This study is the next step in proving mirtazapine's efficacy in treatment of PTSD.   "
187596|NCT00302120|"     The purpose of this study is to determine whether performing MRI of the breast will improve     breast cancer management by reducing the number of biopsies and in case of malignancy     allowing one-stage surgical excision of the tumor.   "
187597|NCT00302133|"     The purpose of this study is to test the efficacy of naltrexone and valproate in the     treatment of comorbid bipolar disorder and alcohol dependence.   "
187598|NCT00302146|"     This study will use positron emission tomography (PET) to compare how people with Gaucher     disease or Gaucher disease carriers with parkinsonism, and their family members, use dopamine     in their brains in comparison with healthy normal volunteers and people who have Parkinson     disease. PET assesses organ function by measuring metabolism. In this study, magnetic     resonance imaging (MRI) is used in conjunction with PET to help better interpret and     understand the information gleaned from PET.      People 21 years of age and older with the following conditions may be eligible for this     study:        -  Gaucher disease and parkinsonism        -  Parkinsonism and a family history of Gaucher disease        -  Gaucher disease and a family history of parkinsonism        -  Gaucher disease carriers who have parkinsonism or a family history of parkinsonism        -  Unaffected people with a family history of Gaucher disease and parkinsonism        -  Healthy volunteers      Participants undergo the following tests and procedures:        -  Personal and family medical history        -  Physical examination        -  PET scan: The subject lies on a table that slides into the PET scanner until his or her          head is positioned properly in the scanner. A catheter is inserted into a vein. An          initial scan is done to obtain images before radionuclides are injected. Radioactive          water is then injected through the catheter and the subject is asked questions in order          to stimulate blood flow in certain areas of the brain to show what parts of the brain          are activated. Fluorodopa is then infused through the catheter over 3 minutes. The PET          scan can last up to 2 hours.        -  MRI scan: This test uses a magnetic field and radio waves to obtain images of organs.          The subject lies still on a bed in the middle of a circular scanner for about 30          minutes.   "
187625|NCT00302497|"     The long-term use of calcineurin inhibitors in the maintenance phase after kidney     transplantation is associated with typical adverse effects, such as potential contribution to     progressive impairment of renal function, hypertension, and metabolic abnormalities.      This 15 month study with a safety follow up is undertaken to evaluate the potential benefit     of an alternative treatment strategy to the chronic use of CNI. It will establish, through a     comparative design, the superior protection of kidney function provided by chronic usage of     basiliximab over tacrolimus early post-transplantation using EDC kidneys.   "
187626|NCT00302510|"     The purpose of this study is to assess the efficacy and safety of immunoadsorption in the     treatment of lipoprotein glomerulopathy.   "
187637|NCT00302653|"     The purpose of this study is to determine whether rasburicase is effective and safety in     correcting hyperuricemia.   "
187599|NCT00302159|"     Background:        -  Radiation therapy with temozolomide (an anti-cancer drug) is standard therapy for          treating brain tumors called glioblastomas.        -  The drug valproic acid, currently approved for treating seizures, has been shown in          laboratory tests to increase the radiosensitivity of glioma cells.      Objectives:      -To determine the effectiveness of adding valproic acid to standard treatment with radiation     therapy and temozolomide for treating glioblastoma.      Eligibility:      -Patients 18 years of age and older with glioblastoma multiforme who have not been previously     treated with chemotherapy of radiation.      Design:        -  This Phase II trial will enroll 41 patients.        -  Patients will receive radiation therapy to the brain once a day, Monday through Friday,          for 6 1/2 weeks.        -  Patients will take temozolomide once a day by mouth, Monday through Friday, during the          period of radiation treatment. Starting 4 weeks after radiation therapy, patients will          take temozolomide once a day for 5 days every 28 days for a total of six cycles.        -  Patients will receive valproic acid by mouth twice a day beginning 1 week prior to the          first day of radiation therapy and continuing until the completion of chemotherapy and          radiation therapy.        -  Patients will have follow-up visits 1 month after completing therapy, then every 3          months for 2 years, and then every 6 months for 3 years. Follow-up includes a physical          examination, blood tests and magnetic resonance imaging of the brain.   "
187600|NCT00302172|"     To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.   "
187601|NCT00302185|"     Research question: Can acupuncture improve symptom control and quality of life (QOL) in     patients with advanced incurable cancer?      The purposes of this study is to investigate the feasibility of performing a randomized trial     with acupuncture in improving symptom control and quality of life (QOL) in patients with     advanced incurable cancer at the BC Cancer Agency, Vancouver Island Centre in Victoria.      We will:        -  Evaluate whether subjects who are receiving palliative care for cancer related symptoms          can tolerate and complete to a course of acupuncture treatments.        -  Evaluate whether it is possible to conduct a study using acupuncture on cancer patients.   "
187602|NCT00302198|"     The purpose is to collect data for ALS research. The data will be used to learn more about     the origin of ALS and to improve quality of care for people with ALS. The information you     provide in the ALS registry will be used to evaluate variations in patient care, adherence to     standards of care and also to help foster ALS research.   "
187603|NCT00302211|"     The purpose of this multi-center international trial is to evaluate the safety and     effectiveness of adding iloprost or placebo (an inactive substance that contains no active     study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will     also examine whether patients on sildenafil can reduce the number of iloprost inhalations     from the approved 6 doses per day to 4 doses per day.   "
187604|NCT00302224|"     The study is designed to test the safety, tolerability of a newly developed form of     ketoconazole (DIO-902) for the treatment of elevated blood sugars in type 2 diabetes. This     study also will also examine the effect of the drug on total and LDL cholesterol and blood     pressure. Elevated cortisol may contribute to the development of Type II diabetes. The     investigational drug DIO-902 may reduce the level of cortisol in blood and therefore provide     better control of blood sugar levels in patients with Type II diabetes.   "
187605|NCT00302237|"     The purposes of the registry are: 1) To provide an ongoing post-market surveillance mechanism     to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and     RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions.     3) To evaluate the adequacy of Abbott Vascular's physician training program.   "
187606|NCT00302250|"     The primary objective of the double-blind segment is to compare effects of alagebrium vs     placebo on change from baseline in endothelial function, as assessed by flow-mediated     vasodilation (FMD).   "
187607|NCT00302263|"     To investigate the 5-hour acute effect on energy expenditure, substrate oxidation and ad     libitum food intake after intake of the Metobes-compound (green tea extract, capsaicin,     tyrosine, caffeine). Furthermore, to investigate if the effect of the Metobes-compound can be     inhibited by blocking the β-adrenergic receptors.      The effect of the Metobes-compound will be investigated by:        1. 5-hour energy expenditure and respiratory quotient (ventilated hood).        2. 5-h change in blood pressure and heart rate        3. 5-h change in sympathetic/parasympathetic ratio.        4. Ad libitum energy intake.        5. Self-reported postprandiel appetite sensations (VAS).   "
187608|NCT00302276|"     The objective of the present study was to investigate the acute and sub-chronic effect of a     supplement containing green tea extract, capsaisin, caffeine, tyrosine and calcium or placebo     taken t.i.d on thermogenesis, body fat loss, and fecal fat excretion. Furthermore, if a     8-week supplementation could prevent weight-regain after initial 4-week weight loss.   "
187609|NCT00302289|"     The primary aim was to measure the effect of green tea extract, tyrosine and caffeine on     energy expenditure, appetite ratings and spontaneous energy intake together with recording of     side effects in healthy normal weight subjects.   "
187610|NCT00302302|"     The purpose of this study is to investigate the effect of L-arabinose in a sugar-rich meal on     intestinal sucrase activity in healthy volunteers by measuring postprandial blood glucose and     insulin, and selected intestinal hormonal responses to increasing doses of L-arabinose.   "
187611|NCT00302315|"     This study aims to investigate the effectiveness of physiotherapy applications in early     postcesarean problems.   "
187627|NCT00302523|"     The purpose of this study is:        -  To explore the potential role of tacrolimus in the treatment of membranous nephropathy.        -  To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus          cyclophosphamide.   "
187628|NCT00302536|"     The purpose of this study is to assess the efficacy of Tacrolimus Treatment of patients with     idiopathic focal segmental glomerulosclerosis.   "
187629|NCT00302549|"     1. To compare the efficacy of FK506 vs intravenous cyclophosphamide pulses in the treatment          of class III-IV LN.        2. To compare the safety and tolerability of FK506 vs intravenous cyclophosphamide pulses          in the treatment of class III-IV LN.        3. To explore the dosing of FK506 and its effective range of blood concentration.   "
187630|NCT00302562|"     Investigate the role of MMPs in the CXCL12-induced invasion of laryngeal and hypopharyngeal     squamous cell carcinoma   "
187612|NCT00302328|"     The project is a randomized clinical trial with a follow up time of 12 months comparing the     effects of surgical treatment of idiopathic macular holes. Patients are randomized to     vitrectomy alone, vitrectomy plus indocyanine green (ICG) assisted inner limiting membrane (     ILM) peeling or vitrectomy plus trypan blue (tb) assisted ILM peeling. At baseline patients     are characterized using early treatment diabetic retinopathy study (ETDRS) visual charts,     tests of aniseikonia, optical coherence tomography 3 (OCT3), visual field and fundus     photography. Per- and postoperative complications are registered.      Data analyses will help clarify the effect of ILM peeling on hole closure and visual acuity.     Comparing results after ICG- and tb assisted ILM peeling will help clarify the topic of a     toxic effect on retinal cells after staining and peeling of the ILM. Changes in intraretinal     morphology before and after dye-assisted ILM peeling will be studied using OCT3 imaging and     the patients' subjective opinion on the surgical results will be analyzed using quality of     life questionnaires and metamorphopsia tests.   "
187613|NCT00302341|"     The purpose of this study is to demonstrate the non-inferiority of pafuramidine maleate     (DB289)versus trimethoprim-sulfamethoxazole (TMP-SMX)for the treatment of mild to moderately     severe Pneumocystis pneumonia (PCP).   "
187614|NCT00302354|"     This is a double-blind, placebo-controlled study, three-period crossover study to examine the     likeability of a single dose of OROS MPH (CONCERTAÒ 90mg) and a single dose of Long-acting     MPH (RITALIN LAÒ 90mg). Hypotheses are as follows:      Hypothesis 1: OROS-MPH (CONCERTAÒ) will be later than SODOS-MPH (RITALIN LAÒ) in its Tmax     (time to Cmax).      Hypothesis 2: The subjective feelings of detection and likeability would be greater for     SODOS-MPH (RITALIN LAÒ) than for an equivalent total dose of OROS-MPH (CONCERTAÒ).   "
187615|NCT00302367|"     The specific aim of this study is to document the pharmacokinetics of DAT receptor occupancy     of OROS and immediate release (IR) MPH using PET scanning with C-11 altropane as the ligand.     We hypothesize that the time to maximal receptor occupancy and the degree of receptor     occupancy of immediate release (IR) MPH will be shorter and greater (respectively) than with     an equipotent dose of OROS MPH.   "
187616|NCT00302380|"     The primary objective of this study is to evaluate the Binding Potential in subjects with     ADHD and adults without ADHD: the intent being to demonstrate that C-11 Altropane PET can be     used to differentiate adults with ADHD from healthy control subjects.   "
187617|NCT00302393|"     There are two specific aims of this study. The first is to document the pharmacokinetics of     dopamine transporter (DAT) receptor occupancy of repeated administration of orally     administered, therapeutic doses of a short immediate release-methylphenidate hydrochloride     (IR-MPH) and a long-acting formulation of MPH (OROS-MPH) using positron emission tomography     (PET) scanning with C-11 altropane as the ligand. The investigators hypothesize that central     nervous system (CNS) DAT occupancy of the OROS-MPH to IR-MPH sequence will be greater than     that of IR-MPH to OROS-MPH sequence at 5 hours after the initial administration and that the     CNS DAT occupancy of the other two formulations will be intermediate.      The second aim of this study is to assess whether the abuse liability potential of delayed,     repeated administrations of different formulations of MPH is moderated by the oral delivery     system in which a delivery system with slower onset may be safer than one with more rapid     early release.   "
187618|NCT00302406|"     This is a single-blind study looking at the efficacy and satisfaction of Concerta     substitution in adult subjects with ADHD receiving immediate release methylphenidate.     Subjects will be administered a maximum dose of 1.3mg/kg/day of either methylphenidate or     Concerta. The specific hypotheses of this study are:      Hypothesis 1: ADHD symptomatology in adults with DSM-IV, ADHD will continue to be controlled     in patients switched from MPH IR TID to Concerta.      Hypothesis 2: Patient satisfaction will not decrease in patients switched from MPH IR TID to     Concerta (ie., all patients will be equally or more satisfied on Concerta as compared with     MPH IR TID.   "
187619|NCT00302419|"     The investigators hypothesized that complementary intracoronary streptokinase administration     to primary percutaneous intervention in patients with acute myocardial infarction may provide     further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ     formed or embolized from proximal site (spontaneous or following PCI)] and fibrin.   "
187620|NCT00302432|"     This study aims:      1. to assess the effect of smoking reduction programs (behavior therapy alone or behavior     therapy with cigarette holders; Flowers Menthol plastic cigarettes with menthol) on     cigarette smoking habits in an antipsychotic treated schizophrenia population.   "
187621|NCT00302445|"     An open label, single arm study to evaluate the study and efficacy of efalizumab in     combination with NB-UVB. Weeks 1-12 efalizumab will be administered once a week in     combination with NB-UVB three times per week. Weeks 13-24 efalizumab monotherapy will     continue. Weeks 25-36 subjects will be followed for safety.      Subjects with moderate to severe plaque psoriasis often require more than one therapy to     treat their disease. Because of the different mechanisms of action, it is thought that     combined efalizumab and NB-UVB may be more effective and have a more rapid onset than either     treatment alone.   "
187622|NCT00302458|"     This is a double-blind, randomized, placebo-controlled, five-period crossover study to     examine the likability of a repeated administration of immediate release methylphenidate     hydrochloride (IR-MPH 40 mg) and OROS®-MPH (CONCERTA® 72 mg) in healthy adults. Hypotheses     are as follows:        -  Hypothesis 1: the subjective feelings of detection and likeability will be greater for          periods of IR-MPH administration than after OROS-MPH administration irregardless of          sequence;        -  Hypothesis 2: the greater ratings of feelings of detection and likeability will be          associated with the periods of most rapid change in plasma d-MPH and not with the          magnitude of plasma d-MPH concentration (other than the OROS-MPH to IR-MPH condition in          which they coincide), and        -  Hypothesis 3: the subjective feelings of dislike will be greatest for the two conditions          in which IR-MPH is the second condition.   "
187623|NCT00302471|"     This two part study will evaluate the safety and tolerability of MK0429 in addition to     assessing it's pharmacokinetic profile and pharmacodynamic response.   "
187631|NCT00302575|"     The main purpose of this study is to examine whether improved integration between the     community supervision system and outpatient addiction treatment system can improve treatment     adherence, drug use and public safety outcomes among drug-involved inmates re-entering the     community.   "
187640|NCT00302692|"     Advances in medical care have increased the proportion of elderly Americans and enabled them     to remain more physically active. This has resulted in an unprecedented increase in the     number of geriatric patients admitted to trauma centers. The elderly constitute 23% of trauma     center admissions, but 36% of all trauma deaths. This disproportionately high mortality is     attributable to a higher prevalence of pre-existing conditions, particularly, cardiac     disease. Multi-system injuries result in critical cardiac stress. Although beta-blockade has     been shown to decrease morbidity and mortality in patients at risk for myocardial infarction     after elective surgery, their use in trauma patients with potential underlying cardiac     disease has not been previously studied. We hypothesize that routine administration of     beta-blockers after resuscitation will reduce morbidity and mortality in elderly trauma     patients with, or at risk for, underlying cardiac disease.      This study is a randomized, prospective clinical trial. One cohort will receive routine     trauma intensive care, and the other, the same care plus beta-blockade after completion of     resuscitation. The primary outcome will be mortality. Secondary outcomes include MI, length     of stay, organ dysfunction, cardiac, and other complications.      Changes in outcome may not be due to reduction in myocardial oxygen demand and heart rate.     Laboratory studies demonstrate that circulating inflammatory cytokines contribute to cardiac     risk in trauma patients, and their production is influenced by adrenergic stimulation. We     will measure circulating IL-6, TNF alpha, IL-1beta, and measure NF-kB and p38 MAP kinase     activation in peripheral blood leukocytes, and determine the effect of beta-blockade on the     production of these inflammatory markers.      Finally, the wide variation in patient response to beta-blockers is attributed to genetic     variability in the adrenergic receptor. Therefore, we will identify single nucleotide     polymorphisms (SNPS) within the beta-adrenergic receptor, and determine their effects on     mortality and response to beta-blockade. This study will provide the first randomized,     prospective trial designed to reduce morbidity and mortality in elderly trauma patients at     risk for cardiac disease. The laboratory and genetic component will provide additional     insights that may explain treatment effects, lead to new therapeutic strategies, and have the     potential to lead to additional areas of investigation.   "
187641|NCT00302705|"     This study was designed in order to evaluate the blood pressure lowering effect of valsartan     compared to enalapril over 24 hours after skipping one daily dose. Both drugs act on the     renin-angiotensin-aldosterone system (RAAS) and are widely use for the treatment of     hypertension. Previous studies had a significant limitation: the effect of a missing dose was     not evaluated after the whole 24 hours post missing dose period (48 hours after last taken     dose), and as a result, it does not imitate the real life situation of a missing dose.   "
187642|NCT00302718|"     The purpose of this study was to determine whether financial incentives for     guideline-recommended treatment of hypertension are effective. We hypothesized that patients     with hypertension cared for by physicians or practice groups receiving financial incentives     were more likely to be prescribed guideline-recommended anti-hypertensive medications and     achieve Joint National Commission (JNC) 7 guideline-recommended blood pressure goals compared     to patients who were treated by providers that did not receive financial incentives.   "
187643|NCT00302731|"     Prospective double blind pilot study comparing bioidentical 'natural' hormones to low-dose     PremPro. Forty participants will be enrolled. The purpose of this study is to try to gather     early information about safety when natural or bioidentical hormones are used during early     menopause.   "
187644|NCT00302744|"     Psychiatric Research Study For Cancer Patients      The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center is conducting a     study designed to measure the effectiveness of the novel psychoactive medication psilocybin     on the reduction of anxiety, depression, and physical pain.   "
187645|NCT00302757|"     The study evaluates the additional use of radioimmunotherapy with a 90-Yttrium labeled     monoclonal antibody targeting lymphoma cells in two dose reduced conditioning regimens for     allogeneic hematopoietic cell transplantation from human leukocyte antigen (HLA)-identical     donors. Radioimmunotherapy should allow an increased anti-lymphoma effect of the conditioning     while the allogeneic grafts may confer potent graft versus lymphoma effects and rescue from     potential hematopoietic side effects of the radioimmunotherapy. The study evaluates the     feasibility and toxicity of such approach and will also analyze disease response and survival     of the patients treated.   "
187646|NCT00302770|"     This trial will explore the efficacy of quetiapine in Social Anxiety Disorder, generalized     type. The following elements of response will be tested: number of responders to treatment,     time to response, effect size as measured with the LSAS   "
187647|NCT00302783|"     The purpose of this study is to test whether multi-source feedback, including self-assessment     and tailored coaching, improves resident communication skills and professionalism. We     hypothesize that residents who are assigned to receive multi-source feedback, in addition to     receiving standard feedback, will improve significantly more than residents receiving     standard feedback alone, as measured by parent and nurse ratings of specific behaviors over     time.   "
187648|NCT00302796|"     A large proportion of patients with Low Back Pain (LBP) (80 %) are classified as     non-specific, due to the lack of a patho-anatomical diagnosis. This term is not     satisfactory, since it implies uncertainty for both the patient and the clinician. Modic     changes have recently been identified as a pain giving patho-anatomical diagnosis for a     considerable percentage (20-30 %) of LBP patients. The causes of these Modic changes have not     been determined conclusively but bacterial infection is among the plausible causes for those     following a disc herniation.      Purpose The aim of this study is to assess the clinical effect of antibiotic treatment     compared to placebo, in patients with LBP and Modic changes following a lumbar herniated     disc.      Design A double blind prospective clinically controlled trial. Patients will be randomized by     a blinded observer to either Group A: 1 antibiotic tablet 45 patients Group B: 1 placebo     tablet 36 patients Group C: 2 antibiotic tablets 45 patients Group D: 2 placebo tablets 36     patients      The patients will take the drug three times a day for 100 days.   "
187649|NCT00302809|"     Recent studies suggest that a diet rich in fruit and vegetables can lower blood pressure, and     a number of lines of evidence suggest that grape products may have such an effect. The     purpose of this study is to determine whether consuming grape juice lowers blood pressure in     individuals with pre-hypertension or stage I hypertension.   "
187678|NCT00294125|"     Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed to treat arthritis. The     purpose of this study is to test the effectiveness of flavocoxid, a plant-derived compound,     for the treatment of knee osteoarthritis (OA) in adults.      Study hypotheses: 1) Flavocoxid has an acceptable safety and tolerability profile as     determined by the Generally Regarded as Safe (GRAS) profile in patients with OA compared to     identical placebo. 2) Flavocoxid will be more effective as a therapy for OA compared to     identical placebo.   "
187703|NCT00303329|"     A 1-year randomized Phase II core trial was conducted to investigate the efficacy of     deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia     2 years of age and older. Patients who successfully completed the main trial may continue in     the extension trial to receive chelation therapy with deferasirox for up to 3 years.     Extension was prolonged to 4 years.      The objective of this study is to assess the long-term safety and efficacy of deferasirox in     these patient groups.   "
187650|NCT00302822|"     HIV infection is diagnosed late in a substantial proportion of patients having an increased     risk of clinical progression (AIDS, new AIDS-defining event or death). The currently     recommended antiretroviral therapy has suboptimal activity in this setting and potent     quadruple-drug therapy has not been sufficiently evaluated. Enfuvirtide may be an appropriate     candidate as the fourth antiretroviral agent, regarding its activity, its parenteral     administration avoiding gastrointestinal symptoms that often lead to interruption of     treatment, the lack of pharmacokinetic interactions and the absence of systemic toxicity.      The aim of this study is to investigate, in a comparative intensification trial, the     immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral     therapy in HIV-1 infected and severely immunosuppressed patients, naïve of any antiretroviral     treatment.      We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting     in emtricitabine/tenofovir combined with either efavirenz or lopinavir/r may improve     immunological restoration, measured as the proportion of patients with more than 200 CD4     cells per mm3 after 24 weeks of antiretroviral therapy.   "
187651|NCT00302835|"     The objective of the international, multicenter case-control study was to evaluate the     association between end-stage renal disease (ESRD) and use of non-phenacetin-containing     analgesics with particular emphasis on combined formulations.   "
187652|NCT00302848|"     EURAS is a multi-national, controlled, prospective, post-marketing, non-intervention cohort     study of new users of drospirenone/ethinylestradiol (DRSP/EE),     levonorgestrel/ethinylestradiol (LNG/EE) and other oral contraceptives (OCs) under routine     conditions of medical practice in seven European countries. Baseline survey and semiannual,     active follow-up are based on postal questionnaires, with validation of reported events by     the women's treating physicians. A multifaceted 4-level follow-up procedure will be     established to ensure low loss to follow-up rates. The objective of the study is the     investigation of the incidence of rare serious adverse events associated with the use of new     and established OCs, and specifically the incidence of thromboembolic events.   "
187653|NCT00302861|"     This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility,     safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients     with previously untreated B-CLL. The length of the controlled portion of the study is two     years. The study will be conducted at investigative sites in the United States.   "
187654|NCT00302874|"     To improve glycemic control of inpatients admitted to the internal medicine wards, the     researchers generated a protocol based on intensive insulin treatment for use in all     inpatients with hyperglycemia.      The researchers hypothesize that intensive insulin treatment will improve the glycemic     control and the outcome of hospitalized patients.      Study Information:        -  All patients with a history of diabetes admitted to the internal medicine ward were          enrolled in the study.        -  At baseline, demographic and clinical information were obtained, including information          necessary to determine the severity of the illness. Venous capillary blood glucose          levels were checked 4 times a day by glucometer.        -  During the pre-intervention period, patients were treated according to the common          practice in the hospital without any intervention. The study team collected the baseline          data on the glycemic control and treatment of patients admitted with hyperglycemia.        -  During the intervention period, the study team visited the ward daily and guided the          medical staff as to the use of the treatment protocol.        -  During the post-intervention period, the study team collected the data without active          intervention in the implementation of the protocol.        -  Data was collected on the mode of treatment and glycemic control of all hyperglycemic          patients throughout the study. The incidence of hypoglycemia, complications (myocardial          infarction, stroke, infections), mortality, transfer to intensive care unit (ICU),          length of hospitalization, and disposition at discharge were noted.   "
187655|NCT00302887|"     The aim of this study was to evaluate the short term and one year follow-up results of     connective tissue manipulation and combined ultrasound therapy (ultrasound and high voltage     pulsed galvanic stimulation) in terms of pain, complaint of non-restorative sleep and impact     on the functional activities in patients with fibromyalgia.   "
187656|NCT00302900|"     Many individuals experience negative reactions when donating blood, including dizziness,     lightheadedness, or fainting. Such reactions may discourage them from donating again. This     study will evaluate the effectiveness of pre-donation water consumption and a muscle tensing     exercise during donation to reduce negative reactions among new blood donors. This study will     also evaluate whether reducing negative reactions increases the likelihood of donors     returning to give blood in the future.   "
187657|NCT00302913|"     This study is a prospective, single-center evaluation of the efficacy of clopidogrel dose     adjustment in patients with insufficient platelet inhibition after elective coronary stent     implantation.   "
187658|NCT00302926|"     Aim: To dissociate the effects on plasma concentrations of the inflammatory marker c-reactive     protein of a negative energy balance and a reduction in body fat stores. Secondly to compare     CRP with fibrinogen and interleukin-6 (IL-6).   "
187659|NCT00302939|"     This study looks at the causes of anemia in adults of all ages who are referred by their     primary care physician.   "
187660|NCT00302952|"     Rheumatoid arthritis (RA) is the most common inflammatory arthritis and a major health     problem. The purpose of this study is to determine the safety and effectiveness of lovastatin     for controlling inflammation in mildly active RA.   "
187661|NCT00302965|"     Measuring the effectiveness of plasma transfusions in critical care   "
187662|NCT00302978|"     We are interested in investigating the functional brain abnormalities of height phobia.     Subjects will be have a functional MRI scan before and after a course of treatment with     behavioral therapy.   "
187663|NCT00302991|"     Observational, multicentre, epidemiological study to determine the HRQOL of patients with     epilepsy according to treatment sub-group and to validate the Spanish version of the Adverse     Events Profile, produced by G. Baker et al. Three treatment groups will be examined: patients     receiving only a new anti-epilepsy drug (AED), patients receiving a classic AED; patients     receiving combination therapy.   "
187664|NCT00303004|"     The purpose of this study is to investigate if combination treatment with Bosentan and     Sildenafil to patients with Eisenmenger syndrome is beneficial.   "
187665|NCT00303017|"     safety, efficacy and acceptability of Flavocoxid   "
187666|NCT00303030|"     A short presentation of a randomized clinical trial of biofeedback and anal injections as a     first treatment option of faecal incontinence.      Background: Faecal incontinence affects mainly women who have suffered sphincter disruption     from vaginal delivery, but individuals of all ages can be affected. The treatment of this     debility is not uniform between institutions or internationally. Often is surgical     reconstruction of the anal sphincter performed, or other invasive, costly treatment options.      The study: We intend to conduct a randomized, controlled, clinical trial where we compare the     effect of two less invasive, less costly treatment options as a first alternative:     biofeedback and anal injections. Our hypothesis is that anal injections will give a better     and more lasting effect than biofeedback. The primary endpoint will be change in faecal     incontinence assessed by the St. Marks incontinence score. Secondary endpoints will include     change in quality of life and several physiological parameters. We intend to include 62     patients in both groups, 124 all together, from 2 centres in Norway. The observation time is     2 years. We plan to include the first patient April 2006, and conclude the study by December     2010. This study can contribute to a more appropriate treatment-algorithm for these patients.      Study group:        -  Barthold Vonen MD PhD, Department of gastroenterological surgery, University Hospital of          North Norway        -  Rolv-Ole Lindsetmo MD PhD, Department of gastroenterological surgery, University          Hospital of North Norway        -  Arvid Stordahl MD PhD., Department of Surgery, Østfold Hospital Fredrikstad        -  Ylva Sahlin MD PhD, Department of Surgery, Innlandet Hospital Hamar        -  Trond Dehli, MD, Department of gastroenterological surgery, University Hospital of North          Norway        -  Kjersti Mevik, Stud. Med, University of Tromso      Project manager: Trond Dehli      Funding, approvals, publication: This study is funded from Northern Norway Regional Health     Authority and The Institution of Norwegian Health- and rehabilitation-organizations. It has     been approved by the Regional Committee for Medical Research Ethics and Norwegian Social     Science Data Services. The results will be published in an international peer-reviewed     journal after the Vancouver-convention's guidelines. The results will also be presented at     national and international conferences.      Contact:      Trond Dehli, Department of gastroenterological surgery, University hospital North Norway,     Breivika, 9038 Tromsø trond.dehli@unn.no tlf: +47 776 26 000   "
187667|NCT00303043|"     In this study the investigators aim to evaluate the utility of a continuous mixed venous     saturation monitoring compared to a clinical examination in a group of critically ill     patients.   "
187668|NCT00303056|"     The primary objective is to compare the overall treatment effect on pain relief between     icatibant and placebo. The secondary objectives are to assess the efficacy of icatibant in     term of onset, extent and duration of pain relief relative to triamcinolone, to evaluate the     safety of icatibant, to evaluate overall conditions of daily life after treatment with     icatibant, to assess systemic exposure of icatibant following intra-articular injection.   "
187669|NCT00303069|"     This is a randomized, Multicenter, double-blind (subject, investigator, and Merck Research     Laboratories (MRL) clinical personnel directly involved in the study), placebo-controlled,     dose-ranging study in healthy adults 18 to 55 years of age. It is the first in man (FIM)     study evaluating the tolerability and immunogenicity of the 0657nI S. aureus vaccine. For     this Phase I study, approximately 120 healthy adults will be enrolled in the study and     randomized to receive a single 0.5 mL vaccination of either 0657nI S. aureus vaccine (3     different dosage levels of 5 μg, 30 μg or 90 μg of the 0657nI vaccine) or saline placebo.     Vaccine/placebo will be administered intramuscularly (IM) in the deltoid muscle. Because this     study will be the first study evaluating the tolerability and immunogenicity of 0657nI S.     aureus vaccine in humans, a dose-escalation phase will be conducted in a small number of     subjects randomized in a 3:1 ratio (n=36, consisting of 9 subjects for each of 3 vaccine     dosage levels and 9 placebo subjects) to evaluate the vaccine safety at increasing dose     levels of the 0657nI protein in Panel A, before expanding the enrollment to the remaining 84     subjects in Panel B.   "
187670|NCT00303082|"     The trial intends to evaluate the efficacy of specially designed probiotics to prevent     premature birth and related neonatal morbidity associated to intra-uterine infection. The     tested probiotics are efficacious to decrease the prevalence of bacterial vaginosis. The     study hypothesis is that the early administration of those probiotics to pregnant women with     bacterial vaginosis can prevent premature birth through antibiotic activity and modulation of     the immune response to infection.   "
187671|NCT00294034|"     The purpose of this study is to collect data from pacemakers and determine how this     information is used by physicians to care for their patients with pacemakers.   "
187672|NCT00294047|"     This is a multicentre study in which women were planned to receive either the Human     Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study     participation will last approximately 48 months and involves a total of eleven scheduled     visits. Under Protocol Amendment 4, study participation will last up to 84 months and     involves a maximum of seventeen scheduled visits.   "
187673|NCT00294060|"     The P3 Study is a United States post market study to gather data on clinical status, primary     indications, device therapy choices, clinical management and outcomes for patients with     implantable pacemakers.   "
187674|NCT00294073|"     The study aims to compare standard techniques used to control pain after knee surgery. The     investigators hypothesize that the fascia iliaca block is faster, safer and as good as or     better than the femoral block, with or without a stimulating catheter.   "
187675|NCT00294086|"     This study will evaluate the tolerability and safety of valsartan in patients with stable,     chronic heart failure (NYHA Class ll-lll). The 12-week double blind study has a 2-week     (maximum) screening, and a 10-week active treatment phase. In each of the treatment arms (QD     and BID), patients are up-titrated to a maximum valsartan total daily dose of 320 mg.     Patients remain on their prior CHF standard care therapy throughout the study period, and the     up-titration of valsartan is based on patient tolerability.   "
187676|NCT00294099|"     The purpose of this study is to compare how the body reacts to different strengths of the new     A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide     dosing information. How the body's immune system responds to the new H5N1vaccine with     aluminum hydroxide approximately 1 month following receipt of 2 doses of vaccine will also be     evaluated. The vaccine is given as an injection or shot in the arm. Volunteer participants in     this study will be 600 healthy elderly adults, aged 65 years and older. Participants will be     randomly assigned to 4 different dosage groups of vaccine, either with or without adjuvant,     for a total of 8 different groups. Volunteers will participate in the study for 7 months.     Each individual will receive two vaccinations, the second 28 days after the first. In     addition to visits for these vaccinations, subjects will return to the clinic for physical     evaluations and blood sample collection 6 times during the course of this study.   "
187677|NCT00294112|"     Human mesenchymal stem cells (MSCs), derived from healthy adult volunteer human donors, can     be obtained from bone marrow donation and cultured in the laboratory. MSCs have shown the     ability to find injured tissue, reduce and control inflammation, and assist in tissue repair.      Prochymal™ MSCs will be infused into patients with moderate-to-severe Crohn's disease.     Infusions will occur on two separate days, 7-10 days apart. Patients will be monitored for     reduced Crohn's disease symptoms.   "
187680|NCT00294164|"     This study is a Phase 2/3, multicenter, double-blind, randomized, parallel-group,     placebo-controlled, dose-finding trial of Serostim® (mammalian cell-derived recombinant human     growth hormone, r-hGH) versus placebo in subjects with human immunodeficiency     virus-associated adipose tissue redistribution syndrome (HARS).      The primary study objective is to determine whether Serostim® treatment reduces adipose     tissue maldistribution more effectively than placebo. The primary co-endpoints are derived     from measures of visceral adipose tissue assessed by computerized tomography (CT) and the     ratio of trunk; and limb fat assessed by dual-energy X-Ray absorptiometry (DXA) scans.     Anthropometric measures, physical exams, quality of life assessments, serial photographs, and     various laboratory measures will be used to address secondary objectives. These secondary     objectives relate to the impact of Serostim® on Physician and subject assessments of change     in body shape, health-related quality of life, attitude towards medication compliance,     metabolic markers, fat redistribution, and safety.      On Day 1, eligible subjects will be randomized in a 1:1:1 ratio to receive daily Serostim®,     Serostim® and placebo given on alternate days, or daily placebo. Serostim® doses will be     based on body weight, with a maximum dose of 4 milligram (mg).      Therapy will continue for 12 weeks. Treatment will then be altered and the new treatment will     be continued through Week 24. Interim Study Visits will be required at Weeks 2 and 4     (Treatment Period 1) and at Weeks 14 and 16 (Treatment Period 2). Subjects will be offered to     be enrolled into a maintenance Protocol (Study 23056) at Week 24.   "
187681|NCT00294177|"     Gestational trophoblastic disease comprises a spectrum of diseases with different propensity     for local invasion and metastasis, that is, partial and complete hydatidiform mole,     choriocarcinoma, and placental site trophoblastic tumor.All trophoblastic tumors produce hCG,     and monitoring of therapy is largely based on the determination of hCG in serum. The     conformational change of tumor markers during antineoplastic chemotherapy for cancer and its     clinical meaning has only been rarely studied. In this study, we will try to understand the     conformational change of the tumor marker (hCG) during chemotherapy.   "
187682|NCT00294190|"     This proposed phase II trial will investigate weekly topotecan at a higher dose than was used     in the previous trials in an attempt to achieve improved response rates and disease control     without added toxicity. To help ameliorate the fatigue, planned rest weeks will be     incorporated into the schedule. This trial will be the first clinical trial to evaluate a     higher dose of weekly topotecan in the treatment of extensive-stage SCLC.   "
187683|NCT00294203|"     This pilot study is looking at how well epoetin alfa, given in the immediate post-operative     period, works in reducing anemia and the need for transfusions.   "
187684|NCT00294216|"     The purpose of this study is to investigate the effect of intake of Omacor (Omega-3-acid     ethyl ester 90) 2g/day on specified parameters related to the stability of carotid plaque in     patients awaiting endarterectomy.   "
187685|NCT00294229|"     Context: Acute low back pain (LBP) is a common reason for consultations in primary care.     Reducing the pain in the first hours and days and restoring the functional capacity of the     lumbar spine may result in a decrease in medical costs and earlier return to work.      Objective: To determine the impact of spinal manipulation on pain and analgesic use in acute     low back pain.   "
187686|NCT00303108|"     The purpose of this study is to determine the ORR associated with Doxil in combination with     carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC).   "
187687|NCT00303121|"     Clinic-based evaluation of patients compliance with topical medications in the treatment of     glaucoma. Also assessing effectiveness of delivery techniques among these patients.   "
187688|NCT00303134|"     The purpose of this study is to test the safety and efficacy of islet cell transplants for     the treatment of type 1 diabetes mellitus. It has been shown that normal control of blood     sugar levels can prevent progression of complications (such as kidney disease, nerve damage,     and vascular disease) from diabetes. This research study is designed to see if normal blood     sugar control can be achieved by transplanting pancreatic islet cells into your liver, which     may reduce or eliminate your need for insulin. Patients may qualify to participate in this     research study if they have type 1 diabetes mellitus for at least five years and meet at     least one of the following criteria:        -  Experience hypoglycemic unawareness - Defined as inability to tell when blood glucose is          low (for example, may not feel symptoms such as shaking, sweating, and rapid heartbeat          that usually signify that glucose is low)        -  Have been hospitalized several times in the past year for low blood sugar and/or high          blood sugar        -  Have complications of diabetes such as retinopathy, kidney problems, or neuropathy   "
187689|NCT00303147|"     The purpose of this study is to determine if expressive writing is an effective intervention     for reducing stress, enhancing cognition, and improving quality of life for caregivers of     older adults with dementia   "
187690|NCT00303160|"     This study argues that H.pylori infection, by increasing the production of reactive oxygen     species, increases the utilization of dietary antioxidants(Vit E and Vit C) that serve in     quenching the free radicals, thus decreasing their serum levels and confounding their     protective effect against gastric cancer.   "
187702|NCT00303316|"     This study will assess both the antibody persistence of the investigational vaccine and the     immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers     who participated in an earlier study in order to determine if they are still protected before     they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the     quality of the induced immune memory in response to a booster dose of the same vaccine as in     the primary series.      Primary Objective:      To describe the antibody persistence at 18 months of age and the booster effect of a dose of     PENTAXIM™ on immunogenicity.      Secondary objective:      To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by     the vaccines received during the primary series.   "
188372|NCT00297960|"     Healthy volunteers will undergo euglycaemic hyperinsulinaemic clamp and microdialysis before     and after administration of 10mg olanzapine or 80mg ziprasidone during 10 days.   "
187704|NCT00303342|"     The purpose of this study is to evaluate the change in measures of physiological arousal     before and after behavioral treatment of insomnia.   "
187705|NCT00303355|"     To assess the utility of clinical bedside examination for the measurement of jugular venous     pulse in critically ill patients.   "
187691|NCT00303173|"     Over 10% of women have high blood pressure during their pregnancy which may affect their     health or that of their baby. There are currently no methods to prevent most high blood     pressure in pregnancy and some treatments are not desirable for use in pregnancy. Previous     research indicates that simple relaxation methods can reduce blood pressure and anxiety     levels for some people, but this has not been well-studied, especially during pregnancy. This     pilot study is intended to determine how guided imagery (imagining relaxing scenes) affects     blood pressure and anxiety, and to assess how satisfied women are with this technique.     Sixty-six pregnant women with high blood pressure will be randomly assigned to (1) listen to     a guided imagery audio-compact disc or (2) quiet rest, at least twice-daily for 4 weeks. All     women in both groups will receive all usual care, plus will have their blood pressure     measured regularly during 1 day per week for 4 weeks. This study will determine if imagery     lowers maternal blood pressure, and if further research on imagery effects on pregnancy     health outcomes is feasible.   "
187692|NCT00303186|"     The purpose of this study is to conduct an economic analysis on the cost of conventional     therapy as compared to biologic therapy and the direct/indirect costs of disease management     in patients with refractory psoriatic arthritis (PsA). Primary outcomes are to qualify the     economic burden of refractory PsA care. The secondary outcomes are to assess efficacy,     safety, and cost effectiveness of different therapies.   "
187693|NCT00303199|"     The study of safety of a new organic arsenic compound in the treatment of advanced multiple     myeloma   "
187694|NCT00303212|"     The primary purpose of this study is to determine the effectiveness of telemonitoring     compared with usual guideline-based care in preventing hospitalization for heart failure     patients.   "
187695|NCT00303225|"     This study will test an experimental antiviral drug called SIGA-246 for use against the     smallpox virus (variola). Although smallpox has been universally eradicated, it could     possibly be brought back as a bioweapon. In the event of a smallpox attack, it would be best     to have an antiviral medication in addition to the smallpox vaccine. SIGA-246 has shown to     have activity against other viruses from the same family (orthopoxvirus) that smallpox     belongs to.      Healthy volunteers who are 18-50 years of age and are not pregnant or breastfeeding may be     eligible for this study. Candidates are screened with a medical history and physical     examination, blood and urine tests, and an electrocardiogram.      Participants are randomly assigned to receive a one-time dose of SIGA-246 (either 500 mg,     1000 mg, or 2000 mg) or a placebo (sugar pill) taken by mouth. They report to the clinic in     the morning for the following procedures:        -  Insertion of intravenous (IV) line in the forearm.        -  Blood and urine tests before taking the study drug.        -  Drug administration within 30 minutes of eating a light breakfast.        -  Blood sampling from the IV line at 30 minutes and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 5 and 6,          10 and 12 hours after taking SIGA-246 to determine how the drug is absorbed,          distributed, broken down and excreted. Samples are also collected by needle stick at 24          and 48 hours for the same tests.        -  Electrocardiogram at 2 hours and 24 hours after taking SIGA-246.        -  24-hour urine collection after taking the SIGA-246.        -  Complete diary card at home for 7 days after taking the SIGA-246.        -  Follow-up visits at about 2 weeks and about 4 weeks after taking SIGA-246.        -  Checks for health changes or problems at every visit.   "
187696|NCT00303238|"     The purpose of the study is to evaluate the effect of botanical dietary supplements on     inflammation in healthy people with different genetic responses to inflammation.   "
187697|NCT00303251|"     This study is an open-label, dose-escalating study to delineate the safety, pharmacokinetics     (PK), and pharmacodynamics (PD) of TKI258. Pharmacokinetics and pharmacodynamics will be     performed on all subjects. The eligible subject population consists of subjects who have been     diagnosed with locally advanced or metastatic melanoma that is refractory to standard therapy     or for which no curative standard therapy exists.   "
187698|NCT00303264|"     Functional dyspepsia has been defined loosely as pain or discomfort centered in the upper     abdomen. The symptoms can also include fullness, early satiety, bloating, belching, nausea,     retching and vomiting. These symptoms may present with or without the co-existence of     symptoms of heartburn or gastroesophageal reflux disease (GERD). Functional dyspepsia is a     diagnosis of exclusion in which other disease states, such as ulcer, cancer, etc. are ruled     out and the source of the pain is unknown.      The standard of care for most patients presenting with dyspeptic symptoms has been with     proton pump inhibitors (PPI), regardless of whether or not the patient's symptoms include     acid-related conditions, e.g., heartburn, GERD, etc. Although PPI treatment has yielded some     success in these patients, there is a significant population of patients whose dyspeptic     symptoms are not adequately treated with PPI's alone.      The purpose of this study is to evaluate the use of dexloxiglumide in the treatment of the     symptoms of functional dyspepsia in patients whose dyspeptic symptoms are not being treated     adequately with PPI's.   "
187699|NCT00303277|"     Recent evidence suggests that there is a significant overlap between AD and cerebrovascular     disease. In fact, AD and cerebrovascular disease may share some of the same risk factors,     including hypercholesterolemia. In addition, studies have suggested that the HMG Co-A     reductase inhibitor lipid-lowering agents, known as statins, decrease the risk of AD by up     to 70%; however, effects differed by specific statin use. This study will compare two     statins, simvastatin (which crosses the blood brain barrier) and pravastatin (which does     not), with respect to their ability to alter blood and cerebrospinal fluid (CSF) levels of AD     and inflammatory markers. The primary aim of the proposed study is to determine whether there     is a reduction in Abeta with statins and whether the ability of the statin to cross the     blood-brain barrier will affect its ability to decrease Abeta. If it can be demonstrated that     statins alter AD-associated biomarkers, this would have broad implications for the treatment     and prevention of AD.   "
187700|NCT00303290|"     The goal of this clinical research study is to see if a new interferon which is given only     once a week with ARA-C works as well as standard interferon and low dose ARA-C. The safety of     this treatment will also be studied.   "
187701|NCT00303303|"     Most patients bitten by copperhead snakes do not currently receive antivenom. Some snakebite     victims have long term problems with the function of the limb that was bitten. This study     will determine whether early administration of antivenom to patients with mild to moderate     copperhead snakebites reduces long-term complications.   "
187706|NCT00303368|"     The study is a multicenter four-year outcome study of the natural history of tibial dysplasia     in patients with NF1 and selected patients without NF1. We will obtain information on the     natural history, burden, functional and health status, health-related quality of life, and     surgical interventions/outcomes of tibial dysplasia. The project will also establish a Core     Facility (NOCF) for tissue samples for future studies.   "
187707|NCT00303381|"     The purpose of this study is to determine the safety and efficacy of interferon-beta-1a in     subjects with active ulcerative colitis (UC).   "
187708|NCT00303394|"     Aim: To investigate the therapeutic potential of IL-1Ra in type 2 diabetes.      Rationale: Since the major defect leading to a decrease in b-cell mass in type 2 diabetes is     increased apoptosis, therapeutic approaches designed to arrest apoptosis could be a     significant new development in its management. This approach might actually reverse the     disease to a degree rather than just palliate glycemia. Based on current thinking, treatment     with IL-1Ra appears as a promising approach. The prospected effect is blocking of the     IL-1b-mediated glucotoxicity and thereby to prevent the decline in b-cell mass, together with     a rapid restoration of b-cell function. FDA approval for IL-1Ra in the treatment of     rheumatoid arthritis occurred based on a favourable tolerability profile.   "
187709|NCT00303407|"     To determine the efficacy and to measure the complications of prophylactic anticoagulation     using low-molecular weight heparin in adult cancer patients under palliative care   "
187710|NCT00303420|"     We are investigating a new way of administering alteplase to remove clots from hemodialysis     catheters. Currently, alteplase is left to dwell inside the catheter between dialysis     treatments to dissolve the clot and restore blood flow through the catheter. We have     developed a new way to administer alteplase by advancing it to the tip of the catheter at     regular 10 minute intervals. We hypothesize that our new push protocol will dissolve clots     in hemodialysis catheters better and faster than the current dwell method.   "
187711|NCT00303433|"     Post Operative Delirium is a common and serious risk of surgery. Delirium, when it occurs is     associated with an increased risk of mortality, increase length of stay, and more adverse     outcomes in general, including increased risk of higher level of care required at discharge.      Namenda, which is currently approved for moderate or severe Alzheimer's disease has a unique     mechanism of action than other drugs for this condition. It may have the ability to protect     the brain from more severe consequences of hypoxia, or hypoglycemia. Hence it is being looked     at in this study to see if it can reduce the incidence and/or severity of delirium     post-operatively.   "
187712|NCT00304785|"     To compare the intraocular pressure effect and safety of latanoprost 0.005% given every     evening versus PTFC given twice daily.   "
187713|NCT00304798|"     Evaluate for difference in outcome between hospital admission versus discharge after recent     TIA, and evaluate feasibility of a larger study.   "
187714|NCT00304811|"     The purpose of this study is to compare the outcome of treatment for bacteremic MRSA     infection with vancomycin alone, vancomycin plus gentamicin, vancomycin plus rifampin, and     vancomycin plus gentamicin and rifampin.   "
187715|NCT00304824|"     Glaucoma is one of the leading causes of blindness worldwide. The key feature of glaucoma is     damage to the optic nerve head with loss of retinal ganglion cells and local tissue     remodeling. Neuronal cell death in glaucoma occurs by apoptotic mechanisms1. Apoptosis of     neurons also plays a major role in neurodegenerative diseases, such as Alzheimer's or     Parkinson's disease. An association between glaucoma and these disorders has been described     2-4. Furthermore, it has been reported that the olfactory function is disturbed in these     neurodegenerative diseases5-6. We hypothesize that similar olfactory alterations may occur in     glaucoma which is in fact a local neurodegenerative disease.   "
187716|NCT00304837|"     The purpose of this gene therapy study is to evaluate the safety and efficacy of     intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in     patients with moderate to high-risk Critical Limb Ischemia (a condition in which there is     poor blood circulation in the leg). This trial will assess whether VEGF improves rest pain     and/or heals ulcers in the legs of patients with peripheral artery disease (blockages in leg     arteries.)      VEGF is DNA, or genetic material that will be injected into the leg muscles on three separate     occasions, each 2 weeks apart. Once the DNA is in the leg, it directs the cells of the artery     wall to increase its production of VEGF, which has been shown to cause new blood vessels to     grow. This experimental therapy is designed to grow new blood vessels around blockages in the     leg arteries.      The total length of participation in this study is approximately 1 year and will require     approximately 8 clinic visits within that year. Following enrollment in the study, testing     may be done for cancer screening, blood work, physical exams, vascular testing and eye exams.     There is no charge for any testing or office visits required by the study.      This study has been approved by the Food and Drug Administration (FDA).   "
187717|NCT00304850|"     After surgery, sensitization and hyperexcitability of central nervous system result in acute     and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA)     receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate     analgesic drugs efficacy. Polyamines (putrescine, spermidine, spermine) are essential     components of cells functioning and are also known as allosteric modulators of NMDA     receptors. In animal studies, polyamine-free diet has confirmed these antinociceptive     properties. This research aims at evaluating anti hyperalgesic properties of polyamine-free     diet in women operated on breast cancer versus kétamine   "
187723|NCT00304941|"     This study will characterize risk factors associated with breast cancer development in some     patients. In particular, it will examine the role of insulin in breast cancer in patients     with and without a family history of the disease.      Women 30 to 70 years old who have been diagnosed with breast cancer and matched control     healthy subjects with and without a family history of breast cancer may be eligible for this     study.      Participants undergo the following procedures:        -  Cancer-genetic counseling session, including family history, risk assessment, genetic          testing for BRCA1 and BRCA2 (if criteria is met), interpretation of results and          management options        -  Medical history, including questions about symptoms or diseases, reproductive history,          use of oral contraceptives, body weight, exercise, lifestyle, and demographic issues        -  Drawing of family tree        -  Examination of medical records        -  Blood drawing for genetic and other tests        -  CT scan of the abdomen (approximate time < 1 minute)        -  Filling out questionnaires   "
187724|NCT00304954|"     This study examined whether the anti-inflammatory medicines infliximab, sirolimus or     daclizumab, when given with a participant's current therapies, would prevent the growth of     new blood vessels in the eye in participants with age-related macular degeneration (AMD).      Participants 55 years of age and older with AMD and drusen larger than 63um may be eligible     for this study. Vision in the study eye was between 20/20 and 20/400.      Participants were randomly assigned to one of three treatments - infliximab, sirolimus, or     daclizumab - or to observation only. In addition, participants may have been treated by their     ophthalmologist as needed for their AMD.      Infliximab and daclizumab were given intravenously (through a vein); infusions were given at     enrollment in the study, then at 2 weeks, and then monthly.      Sirolimus was a pill that was taken every other day for the duration of the study. At 6     months, participants were evaluated to see whether continuing treatment would be beneficial.      In addition to treatment or observation, participants underwent the following procedures:      Physical examination at enrollment and 6 months.      Photographs of the back of the eye, fluorescein angiography, indocyanine green angiography     and measurement of retinal thickness at enrollment and months 1, 3 and 6.        -  Fluorescein angiography evaluated the eye's blood vessels. A yellow dye was injected          into an arm vein and traveled to the blood vessels in the eyes. Pictures of the retina          were taken using a camera that flashed a blue light into the eye. The pictures show if          any dye has leaked from the vessels into the retina, indicating possible blood vessel          abnormality.        -  Indocyanine green angiography identified feeder vessels that may have supplied abnormal          blood vessels. This procedure is similar to fluorescein angiography, but uses a green          dye and flashes an invisible light.        -  Optical coherence tomography measures retinal thickness. This test shines a light into          the eye and produces cross-sectional pictures of the retina. These measurements are          repeated during the study to determine whether retinal thickening is getting better or          worse, or staying the same.      Tuberculin skin test and chest x-ray at enrollment and 6 months.      Blood tests at enrollment and months 1, 3 and 6.   "
187725|NCT00304967|"     This study will use a method called dynamic light scattering (DLS) to study the lens of the     eye in young normal subjects. The DLS device uses a very dim laser light to study the lens of     the eye. It detects proteins in the lens, identifying early changes that may make the device     useful in future cataract studies. This study will use DLS to examine the characteristics of     proteins in healthy young lenses that can be used for comparison with lenses in older people     and people with cataracts.      Normal volunteers aged 5 to 21 years may be eligible for this study. Participants undergo the     following procedures:      Medical history      Eye examination with dilation to include:        -  Measurement of visual acuity        -  Examination of pupils and eye movements        -  Examination of the front of the eye (cornea, lens) with a slit lamp bio-microscope        -  Examination of retina with an ophthalmoscope (instrument with a strong light and          magnifying lens)        -  Dynamic light scattering   "
187726|NCT00304980|"     The purpose of this study is to determine the safety and efficacy of     sulfadoxine-pyrimethamine (SP) versus artemether-lumefantrine (Coartem) when administered to     HIV+ and HIV- patients with uncomplicated P. falciparum malaria. Patients will be randomised     to one of the 2 treatment and followed up (until day 14 actively) for 45 days.   "
187727|NCT00304993|"     Lipid abnormalities in people with the Metabolic Syndrome (the Insulin Resistance Syndrome)     are characterized by elevations in triglycerides and LDL cholesterol; low levels of HDL     cholesterol; and small, dense LDL particles. Statins generally do not change LDL particle     size, so often fenofibrate is added. This combination may still not be sufficient. Niacin is     a common third drug added to the treatment regimen, but niacin can increase insulin     resistance. This study compares niacin as a third drug to rosiglitazone, an insulin     sensitizer.   "
187728|NCT00305006|"     A randomized control trial of constraint-induced movement therapy and bimanual training. The     protocols have been developed at Columbia University to be child friendly and draws upon our     experience since 1998 with constraint-induced movement therapy in children with cerebral     palsy.   "
187729|NCT00305019|"     The purpose of this study is to determine the antiviral effects and safety of clevudine 30 mg     once a day (QD) and 50 mg QD in patients infected with hepatitis B virus (HBV).   "
187730|NCT00305032|"     To investigate the effect of weight loss by gastric balloon insertion on parameters of     obstructive sleep apnea.   "
187731|NCT00305045|"     Studies exploring the efficacy of repetitive transcranial magnetic stimulation (rTMS) as a     treatment for refractory major depressive disorder (MDD) have shown significant promise.     Despite this, several questions regarding the treatment parameters needed to optimize     efficacy remain. Moreover, there is also a lack of clear understanding as to the therapeutic     mechanisms involved. For example, several lines of evidence suggest that patients with MDD     have deficits in cortical inhibition (CI) and that these deficits are key to understanding     the pathophysiology of this disorder. With this study, we seek to confirm the therapeutic     potential of an acute course of rTMS for treatment-refractory MDD in a large sample of     patients. In addition, we will strive to clarify the neurophysiological mechanisms through     which rTMS exerts its therapeutic effects, using both TMS and electroencephalography/event     related brain potential (EEG/ERP) measures of neurophysiological activity. Moreover, in this     study, we intend to investigate the efficacy of a maintenance course of rTMS in an effort to     prevent symptom recurrence.   "
187732|NCT00305058|"     The purpose of this research study is to determine which opiate pain medication (morphine or     hydromorphone (Dilaudid)) is more effective in the treatment of acute pain in patients     presenting to the emergency department.   "
187741|NCT00305175|"     The primary objectives of this prospective, observational study are (1) to describe the     long-term cellular, molecular, and clinical effects of hydroxyurea therapy in sickle cell     disease, and (2) to perform hydroxyurea pharmacokinetics studies.      This study will follow sickle cell patients being treated with hydroxyurea for a long period     of time to evaluate the long-term cellular and molecular effects of the drug on the patients'     body. This study will consist of two patient groups. One group will be made up of patients     who have received hydroxyurea therapy before entering the study. The second group will be     made up of patients who have not received hydroxyurea before study entry.   "
187742|NCT00305188|"     Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory     neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and     placebo group.      Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo     group in order to ensure that the efficacy of the chemotherapy is not compromised by the     addition of xaliproden to the chemotherapeutic regimen.      Other Secondary Objectives : study of the neurotoxicity parameters (Duration of     oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of     PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin     treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of     the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free     survival, overall survival).   "
187759|NCT00305422|"     The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic     patients during therapy with quetiapine or risperidone.   "
187733|NCT00305071|"     In conventional treatment for non-complicated bacterial cystitis, 3-day oral antibiotics     could achieve good cure rate. However, severe lower urinary tract symptoms were most     bothersome and only could be partially relieved by NSAID, detrusor muscle relaxants, minor     tranquilizer or pyridium. Some medication associated side effects were complained while     receiving adjuvant medication treatment, including gastro-intestinal discomfort, dry mouth,     blurred vision, lethargy, or allergic reactions. The irritative bladder symptoms from bladder     inflammation had great impact on the quality of life and well tolerable adjuvant therapy     would have clinical benefit to reduce the discomfort from the bladder.      In the past years, cranberry juice or its extract has been proven to have protective effect     on urothelium to prevent further bacterial ascending infection. The commercial cranberry     extract tablets have good tolerability and showed good effect on symptoms reliving and     infection protection on several clinical observation. In acute bladder infection, we could     expect the bioactive components in cranberry could reduce the virulence of pathogens and     assist to eradicate pathogens and to stable the urothelium. In literature review, only little     works focusing on the symptoms relief in acute cystitis patients. To clarify the clinical     benefit on lower urinary symptoms relieving, we attempt to conduct a randomized double-blind     placebo-controlled trial to evaluate the effect of a compound cranberry extract tablet as an     adjunctive modality in treating acute uncomplicated bacterial cystitis in otherwise healthy     female patients.   "
187734|NCT00305084|"     The main objective of the trial is to document the safety of the combination (escalation     doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of doxorubicin, 75     mg/sqm). Safety will be established by clinical and laboratory assessment according to     National Cancer Institute Common Toxicity Criteria (NCI-CTC ).   "
187735|NCT00305097|"     Habitual consumption of coffee may have substantial beneficial effects on glucose metabolism     according to recent findings of epidemiological studies in the U.S., Europe, and Japan.     However, data from longer-term human intervention studies with appropriate outcome measures     are lacking. We will study the effects of caffeinated and decaffeinated coffee consumption on     body fatness, insulin sensitivity and glucose tolerance that may underlie the observed     associations with a lower risk of type 2 diabetes in a randomized controlled trial. We     hypothesize that both caffeinated and decaffeinated coffee will improve insulin sensitivity     and glucose tolerance. Before starting a larger, long-term intervention study, we will     conduct a pilot study to test the feasibility of such a trial. The pilot study will be an     8-week parallel trial in 45 overweight individuals, who will be randomized to drinking 5 cups     per day of 1) caffeinated coffee (n=15), 2) decaffeinated coffee (n=15), or 3) water (n=15).     Body fatness (weight, waist circumference, bioelectrical impedance), insulin sensitivity     (HOMA model), and glucose tolerance (oral glucose tolerance test) will be the primary     outcomes. We will assess the adherence of participants to their assigned treatment by     measuring serum caffeine concentrations, documentation of coffee use in diaries by the     participants, and counting unused coffee packets. We will also obtain feedback from     participants on how to improve compliance in a future trial. If successful, this study will     form the basis for a definitive trial of coffee consumption, body fatness, and glucose     tolerance. Given the extensive use of coffee and the rapidly increasing health burden of type     2 diabetes, such a trial would have important public health implications.   "
187736|NCT00305110|"     The purpose of this study is to determine the safety and speed of onset of 2mg intravenous     hydromorphone (Dilaudid) in patients weighing at least 150 lbs presenting to the emergency     department with acute severe pain   "
187737|NCT00305123|"     The purpose of this study is to learn more about sore throats caused by the germ Group A     Streptococcus (GAS) or Strep. When Strep causes a sore throat, it can be treated with     medicines called antibiotics. However, if not treated, it can lead to heart problems and     other serious diseases. This study will identify the different types of Strep that are     present in children with sore throats. Researchers will check children with sore throats at     least twice weekly among a group of approximately 12,000 children. Study participants will     include children, ages 5-16, attending the public elementary schools in Djikoroni-Sébénikoro,     a low income community in Bamako, Mali. Throat swabs will be obtained and free treatment is     available when a child enrolled in the group complains of a sore throat. The information from     this study may help make a vaccine to prevent Strep infection in Malian children. Children     may participate for the 3 year duration of the study.   "
187738|NCT00305136|"     Recent advances in the field of pain psychophysics that have enhanced the understanding of     pain processing by the nervous system seem to characterize the individual pattern of pain     processing, thereby enabling the prediction of a person’s susceptibility to develop chronic     pain consequent to surgery.      In this project, the researchers propose to apply a wide array of advanced testing methods in     order to prospectively assess the pain modulation pattern of pain free patients about to     undergo an elective thoracotomy. Since about half of post-thoracotomy patients suffer from     chronic neuropathic postoperative pain, the researchers expect to identify which tests     predict a risk for this pain and the relative power of the relevant tests in this prediction,     and to construct a short and applicable tool, the 'pain susceptibility profile', that will     reliably predict the risk for the development of pain. The expected results of this project     will serve the field of pain prevention by identifying patients at risk and tailoring     interventions to reduce the risk of chronic pain.   "
187739|NCT00305149|"     .This study is trying to address change of chemotherapy dosage according to individual     patient response to initial cycles of chemotherapy in order to reduce cumulative dose of     chemotherapy.The study includes patients with early unfavorable and advanced hodgkin     lymphoma. Patients with low risk were started with standard beacopp and only high risk     patients were started with escalated beacopp.Following 2 cycles of therapy the patients were     reassessed.Based on scintigraphy results decision was made regarding further therapylative     chemotherapy for early responders and maximize dose intensity for late responders.   "
187740|NCT00305162|"     The primary objective of this study is to demonstrate that the efficacy of cangrelor is     superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.   "
187807|NCT00306072|"     The purpose of this study is to evaluate two levels of the herbal extract Salacia oblonga     (salacinol) on postprandial glycemia and insulinemia in patients with Type 2 diabetes after     ingestion of a high-carbohydrate control meal.   "
187744|NCT00305214|"     The purpose of the study is to determine the usefulness of Microvolt T Wave Alternans (MTWA)     testing of patients that have had a heart attack and have decreased pumping ability of the     lower chamber of their heart. MTWA testing is a non-invasive test used to detect the     likelihood of developing abnormally fast rhythms in the lower chambers of the heart. The     objective of the study is to prove that if a patient has a positive MTWA test, they will be     more likely to develop abnormally fast and dangerous rhythms in the lower chambers of the     heart. The results of the study will help doctors to determine which patients would benefit     the most from having an Implantable Cardioverter Defibrillator (ICD) implanted.   "
187745|NCT00305227|"     Recurrent urinary tract infections (RUTIS) continue to be a major health problem in women and     are now complicated by increasing antibiotic resistance. New preventive approaches are     needed. Because most women with RUTI lack the normal protective Lactobacillus (LB) in their     vaginal flora, we hypothesized that restoration of LB would reduce RUTIS. In this trail,     women with recent UTI are randomized to receive either LB or placebo vaginal capsules and are     followed for side effects, for colonization with LB and for occurrence of RUTI over hte next     four months.   "
187746|NCT00305240|"     The purpose of the study is to determine the usefulness of microvolt T wave alternans (MTWA)     testing of patients that have had a heart attack and have decreased pumping ability of the     lower chamber of their heart. MTWA testing is a non-invasive test used to detect the     likelihood of developing abnormally fast rhythms in the lower chambers of the heart. The     objective of the study is to prove that if a patient has a negative MTWA test, they will be     less likely to develop abnormally fast and dangerous rhythms in the lower chambers of the     heart. The results of the study will help doctors to determine which patients would benefit     the most from having an Implantable Cardioverter Defibrillator (ICD) implanted.   "
187747|NCT00305253|"     This study will test the efficacy of the NASG on women suffering from obstetric hemorrhage as     compared to hemorrhaging women who do not receive the NASG.   "
187748|NCT00305266|"     The aim of this study is to quantify the effect of IVIG treatment in a group of patients with     chronic inflammatory demyelinating polyradiculoneuropathy(CIDP), who requires continues     treatment of IVIG at regular intervals of 3-10 weeks:        1. During continues treatment of IVIG at regular intervals of 3-10 weeks.        2. During pause in treatment.      Hypothesis:        1. The disease activity in the patients are cyclical correlating to the treatment          intervals.        2. Pause in treatment will increase disease activity, which can be quantified with symptom          scores, disability scales, and clinical test.      Primary effect parameter is muscle strength quantified by isokinetic dynamometry.      Added to the protocol there is an immunological study of inflammatory markers in blood     samples of patients under treatment pause.   "
187749|NCT00305279|"     The purpose of this study is to determine the effects of different amounts of phosphorus in     the diet on hormones that control phosphorus and bone health both in people who are healthy     and in ones who have moderate kidney disease.   "
187750|NCT00305292|"     The UCSF Pain Clinical Research Center (PCRC) is conducting a study of the effects of     modafinil (Provigil®; Vigiver, Alertec), alcohol and the combination on alertness, mood,     visual motor and cognitive performance, and pain sensation. Modafinil is a stimulant drug     marketed as a wakefulness and alertness promoting medication.   "
187751|NCT00305305|"     Dr. Elliott Sherr and his collaborators at University of California, San Francisco (UCSF) are     studying the genetic causes of disorders of cognition and epilepsy, in particular disorders     of brain development that affect the corpus callosum, such as Aicardi syndrome, as well as     two additional brain malformations, polymicrogyria and Dandy-Walker malformation. The goal of     the investigators' research is to use a better understanding of the underlying genetic causes     as a foundation to develop better treatments for these groups of patients.   "
187752|NCT00305331|"     The dopamine agonists, pramipexole (Mirapex) and ropinirole (Requip), are drugs that are used     to treat symptoms of Parkinson's disease. However, these drugs can induce bothersome leg     swelling or edema in about 20 percent of patients. The cause of this edema is unknown but may     be secondary to stimulation of peripheral dopamine receptors in the kidney or blood vessels.     We hypothesise that a peripherally acting dopamine receptor antagonist, will reduce edema in     PD patients. This study will assess the effect of the peripheral acting dopamine D2 receptor     antagonist, domperidone as a potential treatment for dopamine agonist-induced leg swelling.   "
187753|NCT00305344|"     While this study is now completely enrolled, we do hope to develop a next generation cord     blood based study sometime in early 2009. Please continue to contact us if you have a child     with newly diagnosed Type 1 Diabetes (T1D) who alo has their OWN cord blood in storage.   "
187754|NCT00305357|"     Evolution of pain and neural injury will be evaluated at 2 years or longer after the onset of     AHZ by multiple measures. Assessments at 2 years or longer will be compared to those     collected during the first 6 months after HZ in order to test whether or not sensory function     and cutaneous innervation continues to normalize beyond 6 months in subjects who recover from     HZ without severe PHN.   "
187836|NCT00306449|"     The purpose of the present study is to determine whether weight gain may be prevented by a     small group seminar-based two-year educational intervention on healthy lifestyle in freshmen     at the Faculté de médecine de l'Université de Sherbrooke.   "
187755|NCT00305370|"     There is a scarcity of clinical trials assessing the effects of medications in children with     bipolar disorder. This study aims to assess the efficacy of Aripiprazole associated with     Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder     comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not     have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double     blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole     + placebo. The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores     compared to aripiprazole + placebo.   "
187756|NCT00305383|"     The purpose of this study is to examine the rapid virologic response (RVR) at combination     therapy (CT) Week 4 between groups receiving a standard combination peginterferon     alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine     monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.   "
187760|NCT00305435|"     The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured     by platelet counts by cohort dose-escalation design.   "
187762|NCT00305461|"     The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary     function and time to first exacerbation in patients with moderate persistent asthma.     Ciclesonide will be administered once daily in the evening at two dose levels. The study     duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).   "
187763|NCT00305474|"     This study seeks to determine whether adult, non-psychotic, first-degree relatives of     schizophrenic patients who show specific neurocognitive deficits and negative symptoms will     show improvements in these areas following a 6-month, double-blind trial of a low dose (up to     2.0 mg) of risperidone.   "
187764|NCT00305487|"     The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in     children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at     two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a     treatment period (2 weeks).   "
187765|NCT00305500|"     Objectives: To evaluate tolerability and efficacy of escitalopram treatment in high dose than     20-50 mg/d in out-patients with OCD Type of the study: Open label, prospective study.      Number of patients: 100 patients with OCD      Duration of the study: 18-weeks of active treatment, 8-visits:      Dose titration:      One week of 10mg Four weeks of 20mg After 4 weeks of 20mg treatment– if partial/no response,     according to YBOCS score and clinical judgment, dose increase of up to 50mg depending on     response, adverse events, patient preference and judgment of the clinician 12 weeks follow up     on high dose. Total of 18 weeks of follow-up.   "
187766|NCT00305513|"     Unilateral spatial neglect (USN) is believed to be a disorder of attention, characterized by     impairment in the ability to perceive or respond to stimuli presented to the contralesional     space, and which is not attributable to significant sensory or motor deficits. USN has     serious consequences for rehabilitation and long term disabilities. Efforts have been made to     clarify both the theoretical basis of this phenomenon and the rehabilitation methods that     will be best in improving function. The purpose of this study is to try and contribute to     both efforts by examining treatment effectiveness of two methods; one targeting general     arousal (phasic alerting), and the other targeting increasing awareness to left side stimuli     and habit changes. Functional neuroimaging methods (PET [positron emission tomography] and     fMRI [functional magnetic resonance imaging]) have been applied to understand the functional     anatomy of the brain during mental processes. Only a few attempts have been made to use     functional neuroimaging in patients with neurological deficits such as USN, usually     speculations are made based on findings with healthy participants to explain this disorder.     This study's aim is to examine the functional reorganization of the attentional network in     the brain of USN patients while performing visual tasks, by means of functional neuroimaging     techniques, in light of specific rehabilitation techniques.      Patients will be examined before and after 3 weeks of rehabilitation both using standardized     neurobehavioral tests and PET imaging procedures.   "
187767|NCT00305526|"     This protocol will evaluate the effect of cardiac resynchronization therapy (CRT) combined     with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker     therapy was either not tolerated or could not be up titrated to optimal doses before CRT.     Cardiac resynchronization therapy will be combined with automatic implantable cardioverter     defibrillator (AICD, CRT-D) as it has been shown to be associated with an improvement in     prognosis in the patients with left ventricular systolic dysfunction and heart failure.   "
187768|NCT00305539|"     Hypothesis: In giant cell arteritis (GCA), a short initial treatment with anti-TNF may allow     a faster decrease of steroids dosage and therefore avoid some of the adverse events of     steroids.   "
187769|NCT00305552|"     Sarcoidosis is a multisystem disease involving most frequently the lung, the eyes, the lymph     nodes and the skin. Skin lesions may be disfiguring and impair the quality of life.     Thalidomide is a multi-target drug that has been shown to be of benefit in skin sarcoidosis     in case reports. The objective is to assess the efficacy and tolerance of thalidomide in skin     sarcoidosis.   "
187770|NCT00305565|"     This is a postmarket medical device study. The objective of this study is to compare the     safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy administered at different     amounts of electrical charge for the treatment of patients with treatment-resistant     depression (TRD).   "
187771|NCT00305578|"     The purpose of this study is to investigate whether addition of memantine to bipolar     depression patients who have had an incomplete response to lamotrigine (Lamictal) which is     frequently used to treat bipolar depression in the clinical setting. At present, memantine is     approved for use in the treatment of Alzheimer's disease or dementia, but not for use for the     treatment of bipolar depression. Subjects will be asked to participate because they are     suffering from bipolar depression associated and have had an inadequate response to     lamotrigine. Subjects will have to be on at least 100 mg per day, for at least 4 weeks.   "
187772|NCT00305591|"     Hepatic encephalopathy (HE) is a frequent complication of chronic liver disease (cirrhosis)     and involves a wide spectrum of problems from mild impairment of reaction times in driving     and operating machinery through to disturbances in mood, behaviour and conscious levels.      Magnetic resonance imaging (MRI) is a method of obtaining pictures of the inside of the body.     Patients with liver disease have previously been studied with MRI which has highlighted     changes in the brain. This research aims to highlight some of the differences in the way that     the brain functions in patients with liver disease. Using our new, more powerful MRI scanner,     with more sophisticated techniques we hope that the novel combination of MRI techniques can     objectively detect the presence of , and monitor HE.      Study hypothesis: Hepatic encephalopathy (HE) is a reversible, metabolic disturbance of the     brain, associated with low grade brain swelling and disturbances of the chemical balance     within the brain, resulting in functional impairment, the presence of which MR imaging can     detect with sufficient sensitivity to monitor the changes that may occur over time in     response to treatment.   "
187773|NCT00305604|"     To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients     with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.   "
187774|NCT00305617|"     RATIONALE: Determining whether erlotinib passes into the cerebrospinal fluid may help in     planning treatment for some types of cancer.      PURPOSE: This clinical trial is studying how well erlotinib is able to pass into the     cerebrospinal fluid of patients receiving erlotinib for stage III non-small cell lung cancer.   "
187775|NCT00305630|"     Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to     photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration     (AMD). Patients undergoing PDT are randomized to either a periocular corticosteroid injection     with 40 mg of triamcinolone acetonide or observation just prior to PDT. Patients are followed     for 6 months. Primary outcome is leakage from choroidal neovascularization (CNV) at 3 months     on fluorescein angiography.   "
187776|NCT00305643|"     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving radiation therapy     together with capecitabine may kill more tumor cells. Celecoxib may prevent or lessen     hand-foot syndrome caused by capecitabine.      PURPOSE: This randomized phase III trial is studying how well celecoxib works in preventing     hand/foot syndrome caused by capecitabine in patients with metastatic breast or colorectal     cancer.   "
187777|NCT00305656|"     This phase II trial is studying how well AZD2171 works in treating patients with recurrent     glioblastoma multiforme. AZD2171 may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor   "
187778|NCT00305669|"     RATIONALE: Colony-stimulating factors, such as GM-CSF, may help the body build an effective     immune response to kill tumor cells. Giving GM-CSF before surgery may be an effective     treatment for localized prostate cancer.      PURPOSE: This clinical trial is studying how well giving GM-CSF before surgery works in     treating patients with localized prostate cancer.   "
187779|NCT00305682|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. An     umbilical cord blood transplant may be able to replace blood-forming cells that were     destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells from a     donor can make an immune response against the body's normal cells. Giving sirolimus and     mycophenolate mofetil after the transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide     together with total-body irradiation followed by an umbilical cord blood transplant,     sirolimus, and mycophenolate mofetil works in treating patients with hematologic cancer.   "
187780|NCT00305695|"     This randomized phase II trial is studying zoledronate to see how well it works compared to     observation in maintaining bone mineral density in patients who are undergoing surgery to     remove both ovaries. Zoledronate may prevent bone loss in patients who are undergoing surgery     to remove the ovaries.   "
187781|NCT00305708|"     RATIONALE: Drugs used in chemotherapy, such as busulfan and fludarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. A     donor peripheral blood, bone marrow , or umbilical cord blood transplant may be able to     replace blood-forming cells that were destroyed by chemotherapy. Sometimes the transplanted     cells from a donor can make an immune response against the body's normal cells. Giving     antithymocyte globulin before the transplant may stop this from happening.      PURPOSE: This phase I/II trial is studying the side effects of busulfan, antithymocyte     globulin, and fludarabine when given together with a donor stem cell transplant in treating     young patients with blood disorders, bone marrow disorders, chronic myelogenous leukemia in     first chronic phase, or acute myeloid leukemia in first remission.   "
187782|NCT00305734|"     This phase II trial is studying how well giving bortezomib together with gemcitabine works in     treating patients with recurrent or metastatic nasopharyngeal cancer. Bortezomib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving bortezomib together     with gemcitabine may kill more tumor cells   "
187783|NCT00305747|"     RATIONALE: Diindolylmethane may slow the growth of prostate cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of diindolylmethane in     treating patients with nonmetastatic prostate cancer that has not responded to previous     hormone therapy.   "
187784|NCT00305760|"     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune     response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     vaccine therapy together with cyclophosphamide and cetuximab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well vaccine therapy works when given together     with cyclophosphamide and cetuximab in treating patients with metastatic or locally advanced     pancreatic cancer.   "
187785|NCT00305773|"     Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for     their growth. Giving the drug in different ways may kill more cancer cells. This randomized     phase II trial is studying two different schedules of vorinostat to see how well they work in     treating patients with acute myeloid leukemia.   "
187786|NCT00305786|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with     oxaliplatin works as second-line therapy in treating patients with stage III or stage IV     non-small cell lung cancer.   "
187787|NCT00305799|"     RATIONALE: Understanding how oxaliplatin affects hearing loss, dizziness, and peripheral     neuropathy may improve the ability to plan effective treatment for patients receiving     oxaliplatin for solid tumors.      PURPOSE: This clinical trial is studying hearing loss and dizziness in patients receiving     oxaliplatin for solid tumors.   "
187788|NCT00305812|"     RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the     cancer. It may also stimulate the immune system in different ways and stop cancer cells from     growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving     lenalidomide together with melphalan may kill more cancer cells.      PURPOSE: This randomized phase II trial is studying the side effects and best dose of     lenalidomide when given together with melphalan and to see how well they work in treating     patients with multiple myeloma.   "
187790|NCT00305838|"     RATIONALE: Estrogen may cause the growth of ovarian cancer cells. Hormone therapy using     tamoxifen may fight ovarian cancer by blocking the use of estrogen by the tumor cells.     Measuring CA 125 levels may help doctors predict a patient's response to tamoxifen and help     plan the best treatment.      PURPOSE: This phase II trial is studying CA 125 levels in treating patients with relapsed     advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are     receiving tamoxifen.   "
187791|NCT00305851|"     RATIONALE: Music therapy or book discussion may improve quality of life in patients     undergoing stem cell transplant. It is not yet known whether music therapy is more effective     than book discussion in improving quality of life in patients undergoing stem cell     transplant.      PURPOSE: This randomized phase III trial is studying how well music therapy works compared to     listening and discussing books on tape in improving quality of life in young patients     undergoing stem cell transplant.   "
187792|NCT00305864|"     This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when     given together with temozolomide and radiation therapy and to see how well they work in     treating patients with newly diagnosed supratentorial glioblastoma multiforme or gliosarcoma.     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Motexafin     gadolinium may help temozolomide work better by making tumor cells more sensitive to the     drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Motexafin gadolinium may     also make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium     together with temozolomide and radition therapy may kill more tumor cells.   "
187793|NCT00305877|"     This randomized phase II trial is studying bevacizumab to see how well it works compared to     cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in     treating patients with pancreatic cancer that has been completely removed by surgery.     Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Cetuximab may also stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Radiation     therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together     with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells     that remain after surgery. It is not yet known whether bevacizumab is more effective than     cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in     treating pancreatic cancer.   "
187837|NCT00306462|"     Primary Hypothesis:      Acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium     sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24     and 32 6/7 weeks' gestation.   "
187794|NCT00305890|"     Osteoarthritis (OA) occurs when the cartilage between two bones becomes worn down, and the     bones begin to rub against each other in the joint. This often leads to pain, swelling,     decreased joint motion, and the formation of bone spurs (tiny growths of new bone). Being     overweight increases the risk of developing OA and fastens disease progression. This study     will evaluate two different programs, lifestyle behavioral weight management and pain-coping     skills training, in reducing the effects of knee OA in obese individuals.   "
187795|NCT00305903|"     This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible     patients will receive open-label treatment with rivastigmine capsules plus memantine tablets     as add on therapy. This study is designed to evaluate the safety and tolerability of add on     therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)   "
187796|NCT00305916|"     Conventional coronary angiography is the recommended procedure in detection of coronary     stenosis in patients with idiopathic cardiomyopathy. The aim of this prospective study is to     assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in     patients with idiopathic cardiomyopathy in sinus rhythm, compared to conventional coronary     angiography.   "
187797|NCT00305929|"     This is a multi-centre, phase II, open-label, 12-month clinical trial for patients previously     treated with WST09 (Tookad) who have positive prostate biopsies for cancer.      The study aims at delivering a second WST09 treatment for the purpose of eradicating the     localized prostate cancer.   "
187798|NCT00305942|"     This proposed phase II trial will investigate the combination of topotecan/carboplatin in the     first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are     emerging as common treatments for patients with extensive-stage disease. This trial will be     one of the first clinical trials to evaluate a combination of weekly topotecan and     carboplatin in the first-line treatment of extensive-stage SCLC.   "
187799|NCT00305955|"     The purpose of this study will be to:        -  Determine the amount of visual acuity improvement with treatment of presumed bilateral          refractive amblyopia        -  Determine the time course of visual acuity improvement with treatment   "
187800|NCT00305968|"     About 10% of the population in western countries suffer from abdominal pain and change of     bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of     life and they are often not well taken care of within the public healthcare system. They     often feel frustrated and seek both their family doctors, specialists and alternative     medicine for help. Many patients feel they do not know enough about their disease, and the     uncertainty may enhance bowel symptoms. We want to evaluate the effect of patient information     and education in these patients.   "
187801|NCT00305981|"     Family members have poor overall understanding of ICU patients’ prognosis, resuscitation     status and care, defined a priori as less than 75% correct responses to the yes/no ICU care     questions.      Family members of all adult patients admitted to an intensive care of San Francisco General     Hospital will be screened for enrollment and recruited sequentially over a period of nine     months (August 1, 2005-March 31, 2006). We will determine the frequency of family members’     correct responses to the survey questions about ICU care. Family member responses will be     compared to the chart and real-time patient observation reality (gold standard).      Hypothesis # 2 Poor English language comprehension and low education level (defined as not     having completed high school) are risk factors for poor ICU care understanding and knowledge.      During their surveys family members will be asked questions regarding their English language     comprehension and education level. Association of these possible risk factors with low level     of ICU care knowledge will be tested primarily using analysis of variance. Should our     hypothesis #2 prove to be correct, our future goal will be to develop recommendations for     interventions to increase understanding specific for these high risk groups. One of these     interventions is described in Hypothesis #3 below.      Hypothesis # 3 Provision of the results of family members’ knowledge assessment to health     care providers will result in improved ICU care knowledge on subsequent testing.      Subjects will be randomized to two groups—one group’s health care providers will be shown the     results of family members’ initial ICU knowledge assessment; the other group’s providers will     not be given these results. One to two days after providing this summary to providers, all     randomized subjects will undergo a second interview assessing their ICU care knowledge.     Changes in the frequency of correct responses between the two groups will be compared using     mean differences in proportions with 95% confidence intervals.   "
187802|NCT00306007|"     The aim of the study is to evaluate the reliability, validity, and acceptability of the     London Measure of Unplanned Pregnancy (LMUP) in a U.S. population of women. The researchers     hypothesize that the LMUP will be acceptable to a U.S. population and will be reliable and     valid.   "
187803|NCT00306020|"     Cutaneous cancer-related pain is difficult to treat. These patients are often prescribed high     systemic dosages of opioids. Yet, many patients continue to report pain while experiencing     dose-limiting side effects. An alternative approach to systemic administration is to apply     topical medications. The advantage of topical application is the potential of achieving good     analgesia using low dosages with few, if any, systemic side effects. Current clinical data     indicates, that topically applied morphine has an analgesic effect in patients with severe     pain and that it may even improve wound healing. The clinical reports so far have been either     case studies or double blind randomly controlled trials with a very small sample size of     patients. There is still a great deal of information which is lacking about this modality of     treatment regarding on the one hand, the mechanism of action and on the other, clinical     issues. For example, is the mechanism of the effect actually peripheral? What is the adequate     dose of analgesic medication for different types of skin conditions? Wound healing has not     been quantified.      We will apply morphine topically to skin wounds of cancer and evaluate the effect of the     treatment on pain, side effects, quantify wound healing, quantify morphine and its     metabolites in blood and urine.      Should well controlled studies, demonstrate all or any of the peripheral effects of topical     morphine, clinical application of this treatment modality would be possible. This could     contribute towards better treatment of these patients, who have pain which is difficult to     treat and can, at times, be intractable.   "
187804|NCT00306033|"     This study is a double-blind, placebo-controlled, randomized clinical trial to determine     whether IVIG is effective in improving motor scores in patients with myasthenia gravis and     worsening weakness.   "
187805|NCT00306046|"     18 F-fluoride Positron emission tomography (PET) is able to demonstrate and quantify the     metabolic activity locally in the skeleton (1). This technique should, therefore, also be     able to demonstrate a dramatic decrease in the metabolic activity in localized monostotic     Paget’s disease lesions after therapy. In this condition, indeed, the usual biological     markers may be unhelpful to assess the efficacy of therapy, because they are usually     comprised in the normal range for single pagetic localizations, even before therapy (2). The     main purpose of this trial is to assess the early and long term response of pagetic bone to     bisphosphonate therapy.   "
187806|NCT00306059|"     Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney     injury   "
187808|NCT00306085|"     Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic     limbs has been shown to improve collateral vessel formation. In the present study the safety     and feasibility of autologous blood mononuclear cells implantation will be investigated in     patients with severe peripheral atherosclerosis.Twenty cases will be enrolled. Improvement in     the ankle-brachial pressure index (ABI:>0.1), ischemic ulcers and angiography as well as     laser doppler flow will be evaluated until six months.   "
187809|NCT00306098|"     SPECIFIC AIMS:        1. To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes          Mellitus by islet cell transplantation;        2. To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1          Diabetes Mellitus by islet cell transplantation;        3. To assess long-term safety and function of successful islet cell transplants in patients          with Type 1 Diabetes Mellitus;        4. To determine whether the natural history of the microvascular, macrovascular and          neuropathic complications of Diabetes Mellitus are altered following successful          transplantation of islet cells; and        5. To assess the effect of infliximab in preventing early islet destruction, and thereby          eliminating the need for a second donor's islet cells.        6. To assess the effect of etanercept in preventing early islet destruction.        7. To assess the effect of exenatide to improve islet graft function and survival in          subjects that have returned to using exogenous insulin.        8. To assess the ability of exenatide to improve islet survival at time of transplantation.   "
187810|NCT00306111|"     The purpose of this study is to compare the ability of pegfilgrastim vs. filgrastim to     mobilize peripheral blood stem cells in patients with Non Hodgkin-lymphoma in an     intraindividual study   "
187811|NCT00306124|"     This study aims to determine whether levodopa is effective in boosting learning and memory in     healthy subjects and patients with dementia or Mild Cognitive Impairment.      We also examine in healthy subjects using functional magnetic resonance imaging which brain     regions mediate improved learning after levodopa administration.   "
187812|NCT00306137|"     Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients     Undergoing Surgical Procedures for Lung or Esophageal Cancer.   "
187813|NCT00306150|"     The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during     your surgery, is safe and can help reduce the need for a blood transfusion during bladder     surgery.   "
187859|NCT00306748|"     The purpose of this study is to determine the safety and gastrointestinal pharmacodynamics     (stool frequency, stool consistency, stool ease of passage, stool completeness of evacuation)     of MD-1100 acetate administered daily for 14 days.   "
187814|NCT00306163|"     The aim of this study is to compare the responsiveness of lower airways in adult patients     with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment     medication will be administered as follows: ciclesonide will be inhaled once daily at one     dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study     duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study     will provide further data on safety and tolerability of ciclesonide.   "
187815|NCT00306176|"     The aim of the present study is to investigate the influence of systemic exercise,     rosiglitazone administration and combined pharmaceutical and lifestyle intervention on     cardiovascular risk factors   "
187816|NCT00306189|"     The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment     on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60     and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared     with those treated with placebo over 12 months.   "
187817|NCT00306202|"     The purpose of this clinical research study was to establish a recommended phase 2 once daily     (QD) dose of dasatinib and to assess the efficacy of the investigational drug for relapsed or     refractory (resistant to previous treatment) leukemia in children and adolescents. The side     effects that this oral investigational drug may have in children, and the levels of the drug     in the blood, will be studied at different doses.   "
187818|NCT00306215|"     The purpose of this study is to determine whether CCX282-B is effective in treating patients     with moderate to severe Crohn's Disease.   "
187819|NCT00306228|"     The conceptual hypothesis of this study is that, in patients with acute myocardial infarction     and ST-segment elevation, the strategy of performing coronary angioplasty of the culprit     artery with paclitaxel eluting stent significantly reduces the rate of restenosis in     comparison with bare stents.      The conceptual hypothesis of this study is that, in patients with acute myocardial infarction     and ST-segment elevation, the strategy of performing coronary stent-angioplasty of the     culprit artery under the protection of tirofiban 120 minutes after fibrinolytic significantly     improves epicardial and myocardial infusion in comparison with the strategy of performing     immediate intravenous thrombolysis (tenecteplase plus enoxaparine) followed by coronary     angiography and adequate revascularization.   "
187820|NCT00306241|"     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.     Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can     lead over time to cervical cancer in women . This study will evaluate the immune response     induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
187821|NCT00306254|"     To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin     in preventing blood clots in the lungs or deep leg veins of patients after knee surgery   "
187822|NCT00306267|"     The purpose of this study is to assess the safety and effectiveness of PROCRIT (Epoetin alfa)     administered by injection subcutaneously (SC, under the skin), at a dose of 80,000 U once     every four weeks or 40,000 U once every two in anemic patients with cancer not receiving     chemotherapy or radiation therapy.   "
187823|NCT00306280|"     This purpose of this study is to determine whether phototherapy can be used to safely and     effectively treat H pylori.   "
187824|NCT00306293|"     Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days     in a two-way crossover study with a washout period of 7 days in between.   "
187838|NCT00306475|"     The major objective of this proposal is to test the hypothesis that the addition of     divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly     improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a     double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or     schizoaffective disorder.   "
187825|NCT00306306|"     Radiographic contrast agents are administered to all patients undergoing diagnostic or     interventional catheterization procedures. Injection of contrast enables visualization of the     vasculature with X-ray based fluoroscopy or cineangiographic imaging. Unfortunately, the use     of radiographic contrast agents is often associated with severe adverse side effects,     including acute kidney failure. Acute kidney failure following exposure to an intravascular     contrast agent is also known as Radiocontrast Nephropathy (RCN).      Physiologic factors that may put a patient at higher risk of developing RCN include:     pre-existing renal insufficiency, diabetes mellitus, age, cardiovascular disease     (particularly congestive heart failure and low ejection fraction), and dehydration or other     conditions characterized by depletion of effective circulatory volume. These risk factors are     relatively common in patients undergoing catheterization procedures. Treatment of high-risk     patients can be modified, by hydration and/or minimizing contrast volume; however despite     these efforts, RCN remains a well-recognized complication of coronary catheterization     procedures.      Given the frequency and detrimental consequences of RCN, there is a compelling clinical need     for safe and effective therapies to reduce the incidence of RCN. One such potential therapy     is endovascular cooling to induce mild hypothermia. This study has been designed to evaluate     whether endovascular cooling can reduce the incidence of RCN in high-risk patients who are     undergoing diagnostic or interventional catheterization procedures.   "
187826|NCT00306319|"     Pharmacokinetic study in TB patients to determine the effect of rifampicin on the     pharmacokinetic profile of moxifloxacin.   "
187853|NCT00306670|"     The purpose of this study is to evaluate the rate of response when administering rituximab to     suppress or eliminate the anti-body in a patient's blood that inhibits the effectiveness of     their factor replacement product compared to treatment using cyclophosphamide. This is a     Phase 2/3 study to find out what effects (good and bad) and response rituximab has on a     patient and their anti-Factor VIII antibodies. Also, to compare the effect (good and bad) of     the rituximab with cyclophosphamide on a patient and their anti-Factor VIII antibodies to see     which is better. This research is being done because we do not know which treatment regimen     (rituximab or cyclophosphamide) is more effective in eliminating or suppressing the     anti-Factor VIII antibody in patients with acquired Hemophilia A.   "
187854|NCT00306683|"     In children treated for intracranial lesions, the 2 factors of the obesity are : the location     of the lesion (hypothalamic-pituitary region) and craniopharyngiomas   "
187827|NCT00306332|"     T-cell and B-cell depletion in allogeneic peripheral blood stem cell transplantation by using     immunomagnetic negative and positive selection procedures      Background:      Removal of T-cells from the donor graft (T-cell depletion) offers the possibility for     prevention of GVHD and subsequently less transplant related morbidity and mortality after     allogeneic stem cell transplantation (SCT). There are several techniques to deplete T-cells     from the stem cell grafts e.g. physical, immunological and combined physical / immunological     separation methods. All these techniques result in a stem cell graft with sufficient CD34+     stem cells combined with an adequate depletion of T and B cells. CD34+ selected stem cell     grafts are very pure and do not contain any additional cell populations. In contrast,     CD3+/CD19+ depleted grafts still contain NK-cells, monocytes and dendritic cells that are     part of the innate immune system. Theoretically,the presence of these cells may positively     influence immunological reconstitution and the graft-versus-leukaemia (GVL) effect,     respectively, resulting in improved outcome after SCT      Objectives:      To evaluate the differences in immunological reconstitution, transplant related mortality,     disease-free survival and overall survival after T-cell depleted allogeneic SCT for     haematological malignancies using either immunomagnetic CD34+ selection or immunomagnetic     CD3+/CD19+ depletion using the CliniMACS system in approximately 270 consecutive patients.      Additionally in this study in 20 consecutive patients the kinetics of NK-cel reconstitution     and differences in NK-cell repertoire will be monitored. NK-cell mediated anti-tumor     reactivity will be monitored in patients transplanted with and without NK-cells in the stem     cell graft (CD3+/CD19+ depletion, versus CD34+ selection). Secondary objectives are to     evaluate the clinical relevance of minor histocompatibility-specific cytotoxic T-cell     responses for the GVL effect, the kinetics of NK-cell reconstitution and differences in     NK-cell repertoire using the different T-cell depletion protocols.      Design:      Single center prospective randomised phase III study      Population:      Patients eligible for allogeneic SCT according to the standard criteria of our institution     who will receive an allogeneic T- and B-cell depleted SCT with peripheral stem cells of an     HLA-identical sibling donor or an HLA-identical unrelated voluntary (VUD) donor.      Intervention:      T-cell depletion will be conducted using two different techniques: either immunomagnetic     CD34+ selection or immunomagnetic CD3+/CD19+ depletion.      Endpoints:      Primary endpoints are immunological reconstitution, relapse, disease free survival and     overall survival. Secondary endpoints: NK-cell reconstitution and NK-cell mediated     anti-tumour reactivity. Cytotoxic T-cell responses for the GVL effect.      Estimated efforts and risks for participating patients:      We don't expect any extra patient efforts or risks because T-cell depletion is a standard     procedure in our clinic for many years. There is extensive experience with immunological     T-cell depletion techniques. We hypothesize CD3+/CD19+ depletion will favour stem cell     transplant outcome. Immunological and molecular biological studies will be performed on blood     samples already obtained as part of the standard protocol.   "
187828|NCT00306345|"     The identification of patients with potential early organ failure is the key in preventing     admission or readmission to a critical care facility. The primary goal of the Outreach     Project is to ensure that all patients with threatening organ failure receive appropriate and     timely treatment in a suitable area; avoid admission to the intensive care unit (ICU); and     share ICU skills by a partnership in education. The objectives of the study are to determine     whether the introduction of an intensive care unit based medical emergency team, responding     to hospital-wide preset criteria of physiologic instability, will decrease the number of     predefined serious adverse events (SAEs) and to investigate the effects on quality of life     and costs in a general surgery population.      Study Hypothesis: The Outreach intervention will decrease the number of predefined serious     adverse events; increase quality of life; and decrease costs.   "
187829|NCT00306358|"     In the present study the design of the vitamin B12 absorption test, CobaSorb, is further     optimised. We investigate which test – measurement of holotranscobalamin or cobalamins –     could be used for reflection of vitamin B12 absorption. Furthermore, we prolong the duration     of vitamin B12 administration in order to determine the final duration of the vitamin B12     absorption test CobaSorb.      Seventy-eight healthy individuals (age 21-81 years) are treated with three oral doses of 9     microgram cyanocobalamin per day for five successive days. Non-fasting blood samples are     collected on day 1-5 before administration of the first dose of vitamin B12 and on day 8.     Cobalamins and holotranscobalamin are measured on day 1–5 and 8. The performance of the     vitamin B12 absorption test will be evaluated in individuals with borderline or low levels of     holotranscobalamin or cobalamins (below the 75% percentiles) using a change larger than     2CV(day to day) of holotranscobalamin (22%) and cobalamins (12%) to indicate a change caused     by absorption of the administered vitamin B12.   "
187830|NCT00306371|"     Acne can be treated with a mid-infrared laser. We demonstrated safety and efficacy using     lower energy settings in order to make the treatments less painful   "
187831|NCT00306384|"     The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD),     following participation in 1 of 7 controlled studies in patients with type 2 diabetes     mellitus.   "
187832|NCT00306397|"     The main purpose of this study is to investigate, whether a steroid free immunosuppressive     treatment is a valuable alternative in the treatment of de novo kidney transplant recipients     and if it is possible to withdraw calcineurin inhibitors after 3 months.   "
187833|NCT00306410|"     The purpose of this study is to determine the effect of normalization of vitamin D levels on     bone density, immune and adipocyte function in HIV1-seropositive patients.   "
187834|NCT00306423|"     The purpose of this study is to determine whether a rehabilitation program following lumbar     microdiscectomy influences short-term (4 months) and long-term (up to 5 years)outcomes in     quality of life, activity and endurance.   "
187835|NCT00306436|"     Diabetes is the leading cause of end-stage renal disease in developed countries. Hypertension     and metabolic control are known to affect the progression of renal deficiency and patient's     outcome. Our project aims at implementing a multidisciplinary and systematic approach of     diabetic patients with renal deficiency, and at evaluating the impact of metabolic and blood     pressure targets as recommended by current guidelines.   "
187839|NCT00306488|"     Othera Pharmaceuticals' Othera (OT)-551 antioxidant eye drop has the potential for chronic     treatment of the dry form of age-related macular degeneration. This pilot study of up to 10     eye drop tolerant participants with bilateral geographic atrophy is designed to characterize     the effect of 0.45% concentration of OT-551 eye drops given 3 times a day on the progression     of geographic atrophy area over a two-year period. Participants will have one eye randomized     to receive the eye drop and the fellow eye will be observed only.   "
187855|NCT00306696|"     Study examining the effect of different diuretics on fluid retention in diabetics treated     with rosiglitazone.   "
187856|NCT00306709|"     This is a randomized intervention that examines the effect of culturally adapted weight loss     program in African American (AA) females age 40-65. Evidence suggests that AA women are more     successful with weight loss programs that are culturally tailored (Karanja, et al, 2002).     Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from     ATP-III and the CHANGE exercise program, which have shown success independently in previous     clinical trials with AAs.   "
187857|NCT00306722|"     Very often patients receive medication before a diagnostic, therapeutic, or surgical     procedure to help them relax, keep them calm, and to relieve them from pain. This is called     procedural sedation. During procedural (mild-to-moderate) sedation, a patient is first given     a pain-relief medication (analgesic) and then a medication to help him/her relax and keep     him/her calm (sedative). Propofol is the drug commonly used for sedation because it releases     immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol disodium) is     made as a slow release version of propofol with a longer duration of effect.   "
187840|NCT00306501|"     This study will compare several techniques designed to improve the ability to swallow in     stroke patients with chronic dysphagia (difficulty swallowing).      Healthy volunteers 20 to 60 years of age and people 20 to 90 years of age who have had a     stroke resulting in swallowing problems may be eligible for this study. Volunteers are     screened with a medical history, physical examination, and urine test for women to rule out     pregnancy. Stroke patients are screened additionally with a chest x-ray, physical     examination, cognitive screening, swallowing questionnaires, nasoendoscopy (examination of     the nasal passages in the back of the throat using a lighted telescopic instrument) and     FEESST (passage of a thin, flexible telescope through the nose to the voice box),     videofluoroscopy (x-ray of the head and neck during swallowing) and button press training     (learning how to press a button on a table in coordination with swallowing).      All participants undergo the following procedures:        -  Transcranial magnetic stimulation (TMS): A metal coil is placed on the head and sends a          pulse of energy to the brain through the scalp. The muscle response to the pulse is          recorded from the muscles in the throat that are associated with swallowing.        -  Electromyography: A needle is used to insert tiny wires in specific muscles of the          throat to record the muscle response to the TMS pulses.        -  Magnetic resonance imaging (MRI): During brain MRI scanning, subjects lie quietly and          images of the brain are taken.      In addition to the above tests, stroke patients undergo the following:        -  Water test: The subject swallows a small amount of water and the number of times          required to clear the throat or cough is counted. This test is repeated five times.        -  Experimental training. Subjects have a total of 12 60-minute training sessions, one          session a day for up to 5 sessions a week.             -  Button press training: The subject swallows small amounts of water. A device placed               on the throat senses when swallowing occurs. The subject learns how to coordinate               pressing a button on a table in coordination with swallowing.             -  Vibrotactile stimulator training: A device that uses a buzzing vibration is placed               on the throat at times during the swallowing training.             -  Transcranial direct current stimulation (tDCS): Wires attached to sponge electrodes               are placed on the scalp and over the eye. Small electric currents are delivered to               areas of the brain involved with swallowing. This is done at times during the               swallowing training.      Participants may receive one of several combinations of training approaches; all receive the     volitional (button-press) training. Within 5 days of completing training, subjects repeat the     tests. TMS, MRI, MEG and x-ray study of swallowing function are also repeated to see if any     changes have occurred in the brain or in the ability to swallow after training. Patients are     contacted by telephone and in writing 3 and 6 months after training for follow-up on their     swallowing status and oral intake.   "
187841|NCT00306514|"     The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads     to a specific cellular immune response in patients with malignant melanoma at advanced stage     of the disease.   "
187842|NCT00306527|"     The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset)     following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells     or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine     one year before (2004) in the study V58P4.   "
187843|NCT00306540|"     The purpose of this study is to evaluate how effective quetiapine versus placebo is when     added to an existing therapy, in reducing the symptoms of PTSD.   "
187844|NCT00306553|"     The purpose of this study is to evaluate a specific cellular immune response in melanoma     patients that have been vaccinated with a Melan-A VLP vaccine.   "
187845|NCT00306566|"     The purpose of this study is to monitor a specific cellular immune response in melanoma     patients at an early stage of the disease, that have been vaccinated with a Melan-A VLP     vaccine.   "
187846|NCT00306579|"     Introduction      For several years ischemic electrocardiographic (ECG) changes in the acute phase of     ischemic stroke have been reported. Whether these ECG changes reflect true myocardial     ischemia remains controversial. So far no study has assessed different markers of myocardial     ischemia or necrosis in consecutive patients admitted to hospital with an acute ischemic     stroke.      Purpose      The main purpose of this study is to determine the potential burden of reversible and     irreversible myocardial ischemia in patients with an acute ischemic stroke.      Patients and methods      Serial blood samples for measuring troponin T, CK-MB and NT-proBNP are collected in 250     patients with evidence of an acute ischemic stroke admitted to the Department of Neurology at     Odense University Hospital. In addition resting 12-lead ECG recordings will be obtained on a     daily basis, and a 24-hour ST-segment ambulatory monitoring will be performed once within the     first week of hospitalisation. Finally, myocardial perfusion patterns during rest will be     evaluated by means of a myocardial perfusion scintigraphy in patients with an elevated     troponin T level.      Six months later control measurements of troponin T, CK-MB and NT-proBNP and a 12-lead ECG     will be obtained.      Expectations      The study will contribute with original observations in patients with acute ischemic stroke     considering the following issues:        1. The prevalence and characteristics of ECG changes suggestive of myocardial ischemia.        2. The prevalence of transient ST-segment changes on ambulatory monitoring.        3. The prevalence and degree of myocardial necrosis as judged from biochemical markers.        4. The prevalence of reversible and irreversible perfusion defects on myocardial          scintigraphy.        5. The prevalence, size and patterns of NT-proBNP.        6. Whether there is a change in ECG and biochemical markers over a 6-month follow-up          period.      The results may have clinical implications regarding early and late treatment as well as     clinical follow-up of patients recovering from an episode of acute ischemic stroke.   "
187847|NCT00306592|"     The primary objectives of this study are to further evaluate the safety of natalizumab     (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity     following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab     from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS)     therapies.   "
187848|NCT00306605|"     This study is designed to evaluate the emotional experiences of fathers who have preterm     infants who are hospitalized in a (neonatal intensive care unit)NICU setting. In addition, we     will compare the emotional responses experienced by father of surgical NICU babies and     fathers of medical NICU babies.      Our primary hypothesis is that paternal stress levels will be lower for those fathers of     infants who are hospitalized in a medical NICU compared with fathers of infants who are     hospitalized in a surgical NICU.      Secondary hypotheses include: 1) Stress levels for fathers of hospitalized infants will     decrease over time; 2) Depressive symptomatology modulates perceived stress in fathers of     NICU infants.   "
187849|NCT00306618|"     This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well     as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal     Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme     (GBM)   "
187850|NCT00306631|"     This phase 2 study will determine the antitumor activity, based on the objective rate, of     oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with     advanced or metastatic breast carcinoma. The study will also evaluate the safety and response     duration in patients, time to tumor progression, and overall survival in patients following     MKC-1 therapy.   "
187851|NCT00306644|"     The study investigated the effect of rosiglitazone and placebo on carotid intima media     thickness in patients with insulin resistance syndrome and/or type 2 diabetes.   "
187867|NCT00306852|"     The purpose of the Tube Versus Trabeculectomy (TVT) Study is to compare the safety and     efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with     previous ocular surgery.   "
187852|NCT00306657|"     Normal tension glaucoma (NTG) and chronic open angle glaucoma (COAG) occurring progressively     with optimal conventional or intraocular pressure reducing surgery are still unsolved     problems in ophthalmology. The investigators would like to investigate whether or not the     composition of cerebrospinal fluid (CSF) surrounding the optic nerve (ON) in these patients     is pathologic under certain conditions. They therefore compare the CSF taken during optic     nerve sheath fenestration with the CSF taken during a lumbar puncture. The investigators'     hypothesis is that, in patients with NTG and COAG, the composition of CSF surrounding the     affected ON plays an important role in promoting progressive visual function loss.   "
187860|NCT00306761|"     Cerebral palsy (CP) is a non-degenerative neuromuscular disease that can exist at or occur as     a result of birth. Because of damage to one or more parts of the brain that control movement,     an affected child cannot control his or her muscles normally. Prevalence of CP is similar     worldwide, with pronounced severity in underdeveloped countries due to poor health and     financial conditions.      Research should be conducted to find methods of medical treatment to allow affected children     to maintain or regain musculoskeletal functionality. Many children affected with CP spend     much of their days restricted to a rigid wheelchair; limiting muscular and cognitive     development, making it difficult to interact with their environment. The gap to be addressed     by this study is to determine if a wheelchair that is based on the dynamics of human anatomy     can allow enhanced function, while being adaptive to individual growth and development. At     present, there is very little dynamic capability available in commercial wheelchairs to allow     this mobility.      A dynamic wheelchair system was recently designed and a small sample of able-bodied children     has been tested in the chair. It is hypothesized that significant increases in functional     mobility will be achieved in children with CP from the use of this novel wheelchair design.   "
187861|NCT00306774|"     Knee osteoarthritis (OA) is a common and disabling health problem in older adults and for     which there is no cure. The purpose of this study is to determine the effects of vitamin D on     knee OA symptoms and physical function in adults aged 45 years and older.   "
187862|NCT00306787|"     This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day     (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms     compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).   "
187863|NCT00306800|"     The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with     methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the the LED light source     Aktilite CL128, in treatment of patients with multiple actinic keratosis (sun-damaged skin)     on the face and / or scalp   "
187864|NCT00306813|"     This is a multi-center, open label, uncontrolled, non-comparative phase I/II study in     patients with refractory or relapsed multiple myeloma who are eligible for second, third, or     fourth line therapy. Patients will be enrolled sequentially into four dose cohorts. The     feasibility of administrating Revlimid (R) in combination with Doxorubicin and Dexamethasone     (AD) and the MTD of the combination will be determined in the phase I part of the study (Part     A). When the MTD has been established, the efficacy of the combination will be further     evaluated in the phase II part of the study Part B)   "
187865|NCT00306826|"     In patients with impaired glucose tolerance (IGT), the researchers want to study the relative     effects of pioglitazone, simvastatin, or the combination of both on:        -  intima media thickness (IMT) as an easily assessed marker of atherosclerosis        -  heart rate variability (HRV) as a marker of autonomic neuropathy        -  flow-mediated vasodilatation (FMD) of the brachial artery as a marker of endothelial          function        -  vascular and metabolic lab parameters   "
187866|NCT00306839|"     The purpose of the study is to evaluate mid and long term postoperative pain and further     disabling complications in open inguinal hernia repair by Lichtenstein technique after mesh     fixation with fibrin sealant (FS), compared to mesh fixation with sutures.   "
187868|NCT00306865|"     This study will examine how chemical changes in the brain produce symptoms of hand dystonia.     Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive     movement or abnormal postures. In focal dystonia, just one part of the body, such as the     hand, neck or face, is involved. The study will use positron emission tomography (PET) to     find our which areas of the brain in patients with focal hand dystonia differ from healthy     volunteers without focal hand dystonia.      Healthy volunteers and patients with focal hand dystonia between 18 and 65 years of age may     be eligible for this study. Candidates are screened with a medical history and physical and     neurological examinations.      Participants undergo the following procedures:        -  PET scanning: The PET scanner is shaped like a doughnut. The subject lies on a bed that          can slide in and out of the scanner. A custom-molded plastic mask is placed on the face          and head to support the head and prevent it from moving during scanning. Two radioactive          substances - five doses (one per scan) of [15 O] water and one dose of [11C] flumazil          are injected into the body through a vein. The dose of injected radioactive substance is          very small, and they are not harmful to the body. The [15 O] water doses are injected          during the first hour and scans are taken every 10 minutes. The [11C] flumazil is          injected during the second hour. The radioactive substances are detected by the PET          scanner and provide information on the functioning of the brain chemistry.        -  MRI scanning: MRI uses a magnetic field and radio waves to produce images of body          tissues and organs. The patient lies on a table that is moved into the scanner (a narrow          cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur          during the scanning process. Scanning time for this study will be less than one hour.          Subjects may be asked to lie still for up to 10 minutes at a time.   "
187869|NCT00306878|"     The purpose of this clinical research study is to determine the safety, pharmacokinetics,     immunogenicity in humans, the recovery time required from the biologic effects and the     optimal biologic dose range of BMS188667 (CTLA4Ig)   "
187870|NCT00306891|"     The purpose of this study is to determine whether food has any effect on a single dose of     Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of     fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.   "
187871|NCT00306904|"     The purpose of this study is to evaluate the pharmacokinetics, safety and preliminary     efficacy of 3 doses of Cand5. Cand5 is a small interfering RNA molecule that selectively     silences the mRNA encoding for VEGF. The target population are patients with diabetic macular     edema.   "
187872|NCT00306917|"     Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip     arthroplasty   "
187873|NCT00306930|"     This study is a clinical evaluation of survivorship of an acetabular cup system after total     hip replacement using patient examinations and questionnaires.   "
187874|NCT00306943|"     A pre-requisite to the yearly licensing process of the Influenza vaccine (FluarixTM/     Influsplit SSW®) is to demonstrate in clinical studies, the immunogenicity and reactogenicity     of the vaccine composed of the new strains (2005/2006).   "
187875|NCT00306956|"     The purpose of this study is to determine if the introduction of pacifier use to infants at 2     weeks of age, once breast feedings are well established, will affect the incidence and     duration of successful breastfeedings.   "
187876|NCT00306969|"     This is a pilot study of the safety and tolerability of photopheresis in combination with     increasing doses of oral bexarotene in patients with cutaneous T-cell lymphoma.Our hypotheses     are that the combination of bexarotene with photopheresis is safe and that bexarotene will     enhance immune response in the setting of extracorporeal photopheresis in the treatment of     cutaneous T-cell lymphoma (CTCL), resulting in a shorter time to clinical response.   "
187877|NCT00306982|"     This study will investigate the incidence of influenza, disease and various possible     downstream complications and hospitalizations or emergency room visits after routine annual     vaccination of the elderly population with Fluarix™.   "
187878|NCT00306995|"     Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which     most of the population lacks immunity. If such virus is pathogenic to human and demonstrates     the ability to transmit from person to person, the result is a global outbreak of disease     that affects a high percentage of individuals in a short period of time and is likely to     cause substantially increased mortality and morbidity in all countries of the world.     Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have     been directly transmitted to humans, raising concern over the possibility of a new influenza     pandemic among the world's immunologically naive populations. In order to face this kind of     situation, a pandemic influenza vaccine has to be developed.   "
187879|NCT00307008|"     Streptococcus pneumoniae are bacteria which normally live in the upper respiratory tract of     humans. However, these bacteria can also cause severe infectious diseases such as pneumonia,     septicemia and meningitis. Elderly subjects are especially vulnerable to these infections,     and the diseases can result in death. The currently available licensed Streptococcus     pneumoniae vaccine is recommended for prevention of pneumococcal diseases in individuals over     the age of 65. However, the antibody level elicited by this vaccine, is not always     satisfactory in elderly people. To overcome the problem, GlaxoSmithKline Biologicals is     currently developing candidate vaccines that are hoped to work better than the currently     available vaccines. As a first step in this development, the present study is being conducted     in order to evaluate the immune response to the currently marketed vaccine.   "
187880|NCT00307021|"     GSK Biologicals is developing a number of candidate malaria vaccines for the routine     immunization of infants and children living in malaria-endemic areas. The candidate vaccines     are designed to offer protection against malaria disease due to the parasite Plasmodium     falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection     against infection with hepatitis B virus (HBV). This study will evaluate two candidate     vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment     Act, Sep 2007.   "
187881|NCT00307034|"     Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of     age) and after the complete 2, 4, 11 months schedule when co-administered with     DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)   "
187882|NCT00307047|"     The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and     efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V®     arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™     Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston     Scientific.      TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston     Scientific.   "
187883|NCT00307060|"     To compare the blood pressure lowering efficacy, safety and tolerability of a combination     drug to a single drug taken once daily in patients with uncontrolled blood pressure following     a 4-week filter on the single therapy product.   "
187884|NCT00307073|"     Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some     pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart     beat too fast or too slow). Advances in pacemaker technology in recent years include features     that automatically adapt to patient conditions without intervention from the clinician.     Adapta (Model #ADDR01) is a new pacemaker that is designed to provide further automaticity     advances by including the managed ventricular pacing (MVP) feature designed to promote     intrinsic conduction (natural flow of electricity in the heart) by reducing unnecessary     ventricular (lower chamber of the heart) pacing (electrical impulses). Adapta also contains a     feature called TherapyGuide that is designed to allow the user to select certain conditions     for each subject and receive a list of suggested pacemaker parameter value changes based on     those conditions. The purpose of this study is to evaluate the overall system safety and     clinical performance of the Adapta pacing system.   "
187885|NCT00307086|"     The primary objectives of this study are to:        -  To determine the maximum tolerated dose (MTD) of bortezomib in combination with          high-dose melphalan as a conditioning regimen.        -  To determine the safety, tolerability, and response rates of bortezomib given in          combination with high-dose melphalan, as a conditioning regimen, for tandem transplants          in patients with primary refractory multiple myeloma or plasma cell leukemia.      The secondary objectives of this study are to:        -  To determine gene expression profiles (pharmacogenomics) and perform RTPCR for Fanconi          anemia pathway genes, prior to and after treatment with bortezomib, in patients with          primary refractory multiple myeloma and plasma cell leukemia and correlate profiles with          responses to treatment.        -  To determine the time to disease progression and overall survival in patients with          primary refractory multiple myeloma and plasma cell leukemia treated with bortezomib          followed by tandem autologous transplantation        -  To determine the response rates of 2 cycles of bortezomib in patients with primary          refractory multiple myeloma or plasma cell leukemia   "
187886|NCT00307099|"     This study will enroll 460 subjects who have new pulmonary infiltrates during their ICU stay     and who are at low risk of having pneumonia, as determined using the Clinical Pulmonary     Infection Score (CPIS). The study is designed to determine whether 3 days of antibiotic     treatment with meropenem (with or without coverage for MRSA) for ICU subjects diagnosed with     new pulmonary infiltrates can reduce the emergence of anti-microbial-resistant organisms and     the isolation of a potential pathogen compared to a standard course of antibiotic therapy     (minimum of 8 days of therapy with antibiotics of the primary care team's choosing). Subjects     will be randomly placed in either the meropenem group or standard antibiotic therapy group.     The study will also examine whether short-course therapy reduces hospital length of stay and     hospital cost, without having a negative effect on subject morbidity and mortality.   "
187942|NCT00298051|"     The aim of the study was to determine whether delayed umbilical cord clamping, as compared to     early umbilical cord clamping, improves infant iron status at 6 months of age.   "
187943|NCT00298064|"     The Tissue Repository will search for cases, pull slides, Paraffin-embedded tissue (PET)     blocks.   "
187887|NCT00307112|"     A bacterium called Group A Steptoccoccus or strep is commonly found in the nose and throat     of healthy adults and children and can cause a variety of illnesses. If this bacterium     infects another part of the body one or more times, children may get Rheumatic heart disease     (RHD). The purpose of this community based study is to see how many children between 5-15     years of age have RHD in Leon, Nicaragua. The study will also help to determine if the usual     methods of detecting this disease are working. Researchers hope that this study will help to     develop vaccines that may prevent strep infections to Nicaragua and other parts of the     world. About 3,600 children will take part in the study. The children will participate for a     minimum of 1 day and have a 6 month follow-up visit if they are identified as possible or     probable RHD cases. Study procedures will include clinical exams and echocardiograms to     determine the presence of RHD.   "
187888|NCT00307125|"     The purpose of this study is to determine whether treatment with rituximab (anti-CD20,     Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney)     transplant will promote longer-term survival of the transplanted kidney.The pilot study     compares the use of rituximab (Rituxan®) + site-specific standard immunosuppression to     placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA     antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after     transplant.   "
187889|NCT00307138|"     There has been continuing debate about whether use of hetastarch for volume replacement in     coronary artery bypass surgery [CABG] increases the risk of postoperative bleeding. A recent     meta-analysis of hetastarch use in on-pump CABG concluded that use of hetastarch in these     procedures is associated with increased risk, but the safety of hetastarch use in off-pump     procedures remains unresolved.      We designed a double-blinded randomized clinical trial to investigate this question. The     study was designed as an equivalence trial. Statistical power calculations were performed     taking this into consideration. Sealed assignments from a block randomization table developed     prior nto initiation of the trial were unsealed in the operating room. These were used to     assign patients scheduled for off-pump CABG to receive either 1 L of hetastarch or 1 L of     albumin as part of intraoperative volume replacement. Albumin was used for all subsequent     intraoperative and postoperative fluid replacement.      The rate of postoperative bleeding was assessed prospectively by monitoring hourly chest tube     drainage and number of units of blood products transfused postoperatively in the Intensive     Care Unit. Risk was assessed by a Data Safety Monitoring Committee (DSMC) established for     this trial. The SAMC was scheduled per protocol to meet after the first 15 subjects (both     groups combined) had 1000cc or more of chest tube drainage in the first 12 hours     postoperative, and then subsequently either after 15 additional bleeds of this volume or     following a schedule set at the discretion of the DSMC.      The trial was continued until 156 patients had been recruited. At that time, 78 participants     each had been assigned to the hetastarch and albumin groups. DSMC review at that time     determined that use of hetastarch is associated with a risk of postoperative bleeding which     is greater than the risk associated with use of albumin and the DSMC accordingly halted the     trial.   "
187890|NCT00307151|"     A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a     single dose to her infant has been shown to be an effective way of reducing the risk of     mother-to-child transmission (MTCT) of HIV. The purpose of this study was to compare the     effectiveness of a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based     antiretroviral regimen versus a protease inhibitor (PI)-based regimen in HIV infected infants     who had or had not been exposed to SD NVP for prevention of MTCT.      >>      >> A five year follow up has been added to the study.   "
187891|NCT00307164|"     Lipoatrophy, the loss of body fat from particular areas of the body, is a common side effect     of antiretroviral therapy (ART). The purpose of this study was to determine the effectiveness     of uridine supplementation in treating HIV infected individuals on stable ART with     lipoatrophy.   "
187892|NCT00307177|"     The purpose of this research is to compare reactions and antibody responses following receipt     of different doses of the experimental influenza vaccine or standard influenza vaccine.   "
187894|NCT00307203|"     Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic     population often find it difficult to quit smoking. The purpose of this trial is to determine     the safety and effectiveness of bupropion in treating individuals with schizophrenia who     smoke.   "
187895|NCT00307216|"     This study will determine the effectiveness of the Graduated Recovery Intervention Program, a     manual-based individual therapy program, in enhancing the clinical benefit of routine     treatment for individuals recovering from their first episodes of psychosis.   "
187896|NCT00307229|"     To determine the maximum tolerated dose and/or maximum attainable dose of a vaccine     consisting of adenovector expressing rat Her-2/neu in patients with metastatic or locally     recurrent breast cancer.   "
187897|NCT00307242|"     In earlier clinical studies, when patients who have been on lamivudine (LAM) were switched to     adefovir dipivoxil (ADV), some patients developed ALT flares with an elevation of ALT > 10 x     the upper limits of normal (ULN).      There were no cases of hepatic decompensation with the flares, however. The transition     methods were varied among physicians from no overlapping to overlapping for 1 to 3 months     with LAM and ADV. There is still some uncertainty about the optimal approach to switching     from LAM to ADV.      This study will compare the safety of directly switching to ADV to a protocolled switch after     a period of overlap of 12 weeks. This will facilitate pro-active switching in patients on LAM     and will also highlight genotypic resistance ahead of phenotypic resistance as a reason to     switch patients. Data to date have only been presented as part of a controlled study in     patients with clinically evident LAM-resistance. This study will enroll patients who still     have serum hepatitis B virus (HBV) DNA suppression whilst receiving LAM.   "
187898|NCT00307255|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel     albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating     patients with advanced metastatic solid tumors.   "
187899|NCT00307268|"     To evaluate clinical effectiveness of medication treatment for ADHD. It is hypothesized that     the effectiveness is lower than efficacy outcomes measured in clinical trials   "
187944|NCT00298077|"     The study will identify patients with infections commonly observed in transplant recipients,     describe the epidemiology of their infection, study the risk factors associated with various     infections and examine strategies of early diagnosis and prevention of infection   "
187985|NCT00298610|"     The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by     individuals with uncomplicated malaria infection and to determine how fast it eliminates     malaria infection from the body.   "
187900|NCT00307281|"     The Comprehensive Lung Center (CLC) at the University of Pittsburgh Medical Center (UPMC     Health System) provides patients with any type of breathing or lung disorder a full range of     diagnostic and therapeutic services. The Emphysema Research Center (ERC) is a specialty     clinic, within this center, that attempts to advance the understanding of emphysema and to     evaluate new therapies for patients with emphysema. The Emphysema Research Registry will     enable pulmonary research physicians to: 1) gather information and create a research registry     of people who have been diagnosed with emphysema; 2) utilize this research registry with the     purpose of conducting research that attempts to advance the understanding of emphysema and to     evaluate new therapies; and, 3) use the research registry to identify potential candidates     for future research programs. These aims will be achieved by the collection of DNA (genetic     material)for analysis and storage in addition to pulmonary function tests and other medical     information.   "
187901|NCT00307294|"     The primary objective of this study is to evaluate PSA response rates of the combination of     Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary     objectives include: 1) To evaluate the clinical response rate of this combination on     measurable disease 2) To evaluate overall survival for this combination.   "
187902|NCT00297115|"     The aim of the study is to compare the effect of roflumilast on exacerbation rate and     pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast     will be administered orally once daily in the morning at one dose level. The study duration     will be up to 56 weeks. The study will provide further data on safety and tolerability of     roflumilast.      For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673     (toll free).   "
187903|NCT00297128|"     -  feasibility and tolerance of preoperative therapy with Cetuximab in combination with          Capecitabine and radiotherapy for patients with locally advanced operable rectal          carcinoma        -  collection of response rate (T-downstaging, pathological complete remission),          correlation of responsiveness with EGFR-status   "
187904|NCT00297141|"     Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the     preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation     of the toxicity grade III and IV of the therapy scheme   "
187905|NCT00297154|"     A growing number of people in this country are overweight or obese. This is concerning as     increasing weight has been shown to increase the risk of developing heart failure. However,     there is also research to suggest that in people who already have heart failure, heavier     people live longer. So, how does being overweight put a person at risk for heart failure, but     once they have heart failure, protect them? There is no clear explanation for this dilemma.      People who are obese commonly have other diseases, such as high blood pressure, high     cholesterol, and diabetes, that increase the risk of developing heart disease. It is this     group of diseases that is referred to as The Metabolic Syndrome. People with the metabolic     syndrome also have increased levels of inflammation and clotting proteins in their blood     stream. Current treatment of the metabolic syndrome involves using medications for     cholesterol, blood pressure, and diabetes. Diet and exercise are also commonly recommended.      Lifestyle intervention programs are programs that help people lose weight by changing their     eating habits and exercise / activity routines. Weight loss and exercise have been shown to     lower the risk of developing diabetes and improve diabetes control, improve cholesterol     abnormalities, and lower blood pressure. These programs have not previously included heart     failure patients, however.      We hypothesize that using a lifestyle intervention program in addition to the usual     medications for heart failure will result in improved symptoms of heart failure and control     of the metabolic syndrome.      This study will be the first research study to look at the use of diet and exercise in     treating heart failure patients who are overweight / obese with the metabolic syndrome. The     study will last 6 months. From this study we hope to learn whether diet and exercise is     helpful in treating heart failure patients who are overweight. Specifically, the study will     look at the short term effects on cardiac risk factors (blood pressure, cholesterol, blood     sugar), heart failure symptoms, and exercise capacity.   "
187906|NCT00297167|"     The primary efficacy objective of this study is to compare the coefficient of fat absorption     (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals)     pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis     (CF) and exocrine pancreatic insufficiency (EPI).   "
187907|NCT00297180|"     GW869682 causes glucose to be excreted in the urine. The purpose of this study is to see     whether enough calories from glucose are excreted in the urine to cause weight loss.   "
188678|NCT00321152|"     The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin®) is safe and effective     in relieving depression when it is added to standard kinds of antidepressants called     serotonin reuptake inhibitors (SSRIs).   "
187908|NCT00297193|"     Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance     or toxicity to conventional treatment.      The purpose of this study is to determine whether there is a potential clinical benefit of     hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous     stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best     clinical practice.   "
187909|NCT00297206|"     Limited data are available on valaciclovir use in children and valaciclovir is not currently     approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use     in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An     extemporaneous suspension formulation of valaciclovir has been developed to expedite the     provision of benefits to children similar to those from administration of valaciclovir solid     formulations in adults.   "
187910|NCT00297219|"     The high rate of cardiovascular complications in the dialysis population cannot be explained     by traditional cardiovascular risk factors. One of such factors proposed to contribute to the     cardiovascular mortality in dialysis patient population is vascular calcification possibly     resulting from disturbances of calcium-phosphate metabolism.      The aim of this study is to assess the effects of treatment with dialysate containing 1.75 or     1.5 mmol/L to 1.25 mmol/L calcium regarding coronary artery calcification and bone     histomorphometry in hemodialysis patients.   "
187911|NCT00297232|"     The primary objectives for the initial treatment period of this study are to further evaluate     the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions     and immunogenicity following re-exposure to natalizumab and confirming the safety of     switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS)     therapies to natalizumab. The primary objective for the long-term treatment period of this     study is to evaluate the long-term impact of natalizumab monotherapy on the progression of     disability measured by Expanded Disability Status Scale (EDSS) changes over time.   "
187986|NCT00298623|"     The primary objective of this trial is to assess the efficacy of XP13512 taken once daily     compared to placebo for the treatment of patients suffering from Restless Legs Syndrome     (RLS).   "
188177|NCT00308347|"     Evaluate the effect of Losartan in reducing kidney disease in patients with Non-insulin     Dependent Diabetes and Nephropathy (kidney damage that usually accompanies late stage     Diabetes Mellitus).   "
187912|NCT00297245|"     The incidence of cognitive decline related to CPB ranges from 20% to 80%, which may affect     length of hospital stay, quality of life, the rehabilitation process, and work     performance.However, there is no method to prevent the decline.Gastrodin,the active     constituent of gastrodia elata, has been widely used for the treatment of paralysis,     hemiplegia, headache, vertigo, and Alzheimer's disease. Gastrodin is safe. No severe     side-effect has been observed in the treatment. We postulate that gastrodin would attenuate     the causative parameters of cognitive dysfunction related to CPB and would be an effective     drug to prevent the decline as a result.   "
187913|NCT00297258|"     The purpose of this study is to evaluate the activity and tolerability of pazopanib in     subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following     standard therapies or for whom no standard therapy exists and to characterize the     pharmacokinetics of pazopanib in this subject population.   "
187914|NCT00297271|"     The purpose of the PRIME Study is to examine the current management and outcomes of patients     with mild cognitive impairment or dementia. Approximately 4500 patients will be enrolled in     this disease registry across 12 sites in Australia. Clinical, treatment, health status and     economic data will be acquired over 3 years. The study will identify the relationships among     demographic variables, prognostic features, geographic setting, treatment options and     clinical, economic and health status (activities of daily living and caregiver impact)     outcomes.   "
187915|NCT00297284|"     This study is being conducted in order to determine if the FDA-approved drug Modafinil can     improve cognitive function in patients with lupus. Modafinil is currently being used to treat     excessive sleepiness caused by certain sleep disorders. It has also been shown to improve     attention and concentration in some people who don't have lupus or sleep disorders. This     study hopes to determine if Modafinil can be used safely and effectively in lupus patients,     and improve their quality of life. No medications currently exist for the treatment of     lupus-associated cognitive dysfunction.   "
187916|NCT00297297|"     Molecular gene profiling of fine-needle aspiration samples in addition to fine-needle     aspiration cytology can improve the selection of patients with benign versus malignant     thyroid nodules with improved sensitivity.   "
187917|NCT00297310|"     The purpose of this study is to evaluate two groups of kidney transplant recipients, to     determine the proportion of patients that achieve therapeutic blood concentrations of     tacrolimus by Day 3 after transplantation. Patients in one group will be treated with     tacrolimus according current clinical practice. The other group will have a pre-transplant     assessment of their tacrolimus blood level concentration that will be used to guide     post-transplantation tacrolimus dosing. Tacrolimus is a medicine that slows down the body's     immune system. For this reason, it works as an anti-rejection medicine.   "
187918|NCT00297323|"     The purpose of this observational study is to evaluate the safety of topiramate in adults and     children with epilepsy (or seizures) who have not received or have not responded to treatment     with previous antiepileptic medication.   "
187919|NCT00297336|"     A 6-month, observational, post authorization safety study for the collection and evaluation     of additional safety data on topiramate as a prophylactic treatment for migraines in adult     patients. According to current European and international guidelines the safety and efficacy     of drugs will be continuously monitored even after their approval and market circulation.The     applicable methods of monitoring include: Observational studies, voluntarily reported adverse     events, clinical trials of IV phase and Post Authorization Safety Studies ( PASS). Post     Authorization Safety Studies (PASS) during the use of a product are a significant source of     information regarding the action of the drug or a therapeutic method under the circumstances     of every day clinical practice.   "
187920|NCT00297349|"     The purpose of this observational study is to evaluate the safety of topiramate when used in     combination with other medications for seizures in adults and children.   "
187921|NCT00297362|"     The purpose of this study is to evaluate the safety and effectiveness of galantamine     hydrobromide in patients with Alzheimer's disease who have not received or have not responded     to treatment with medication similar to galantamine hydrobromide.   "
187959|NCT00298272|"     The primary objective of this study was to evaluate the tolerability and safety of rituximab     in combination with methotrexate (MTX) and etanercept or adalimumab in participants with     active rheumatoid arthritis (RA). The secondary objective was to explore the efficacy of     rituximab in combination with MTX and etanercept or adalimumab in participants with active     RA.   "
187922|NCT00297375|"     The purpose of this study is to evaluate the effectiveness and safety of tramadol     HCl/acetaminophen as a pain medication compared with placebo in the treatment of acute pain     from a migraine headache. Although tramadol HCl/acetaminophen is approved to treat acute     pain, it is not approved for the treatment of acute pain associated with migraine headache.     The study hypothesis is that tramadol HCl/acetaminophen is safe and effective as a pain     medication in the treatment of acute pain associated with a migraine headache.   "
187923|NCT00297388|"     The purpose of this study is to assess the time for patients to relapse when switched from an     oral antipsychotic to one of two doses of long-acting risperidone injection (shots).     Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.   "
187924|NCT00297401|"     Protein kinase C (PKC), an enzyme in the body, has been implicated in the process of diabetic     microvascular complications. The purpose of this study will be to evaluate the renal     hemodynamic and peripheral vascular effects of PKC inhibition with ruboxistaurin mesylate (an     inhibitor of PKC) in patients with Type 1 diabetes mellitus and evidence of early     nephropathy. In this pilot study, 21 patients with type 1 diabetes were planned to be     randomized to LY333531 or placebo in a 2:1 fashion, after an initial period of testing. After     8 weeks of study drug, patients were retested.   "
187925|NCT00297414|"     The purpose of the study is to collect data of patients who were randomized (assignment of     study medication by chance) and treated in 3 previous studies of galantamine (CR003145,     CR002014 and CR005947) for the treatment of mild cognitive impairment (isolated memory     impairment). This data were not recorded during the course of these 3 previous studies.   "
188002|NCT00298831|"     The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio     of 0.9 after a dose of sugammadex when administered at least 15 minutes after the last     administration of rocuronium in a wide range of surgical procedures and anesthetic regimens     (routine use). Safety evaluation is part of the study.   "
187926|NCT00297427|"     This research study will evaluate the effectiveness of acupuncture in decreasing urinary     incontinence (involuntary urine loss) in women. The study will involve 12 acupuncture     sessions over 6 weeks. We will compare the effectiveness of acupuncture and sham (placebo)     acupuncture (a procedure in which the needle feels like it penetrates the skin, but is not     actually inserted into the body) on the frequency and volume of involuntary (accidental)     urine loss after completing the intervention, and again one month later. Individuals     participating in this study will be randomly assigned to receive either the actual or sham     acupuncture. Randomization means being assigned by chance, similar to flipping a coin. Study     participants will not know which group (actual or sham acupuncture) they were assigned to     until one month after completing the 6-weeks of treatment. The sham acupuncture needles look     similar to the real acupuncture needles and feel like they penetrate the skin, but do not     actually do so. If individuals are assigned to the sham acupuncture group, they will be     eligible to receive the actual acupuncture one month after completing the sham acupuncture if     they wanted to. All individuals will be followed for 6 months after completing the     acupuncture treatments.   "
187927|NCT00297440|"     We seek to: 1) conduct the formative work to adapt the cessation materials and exercise     protocol from focus on adult women to adolescent girls, and 2) conduct a small randomized     pilot trial to determine the preliminary efficacy of the intervention in a sample of     adolescent girls. Therefore, this study, will serve as a pilot for a larger clinical trial.     Successful smoking cessation in adolescent girls could contribute to the future reduction of     chronic disease morbidity and mortality in this group.   "
187928|NCT00297453|"     The study is designed to evaluate and compare the efficacy and cost effectiveness of 3     smoking cessation treatments with HIV-positive cigarette smokers. The treatments include     face-to-face individual counseling, a computer-Internet-based self-help treatment and a     self-help manual treatment.   "
187929|NCT00297466|"     The purpose of this study is to determine whether a brief, focused intervention in the     hospital emergency department is effective in helping adults quit smoking.   "
187930|NCT00297479|"     The goal of this behavioral research study is to create and study a Mindfulness-Based     Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus     attention on being in the here and now. It can be learned through training in how to     control one's attention. It is usually taught through meditation. The overarching goals of     the study are to evaluate the efficacy of MBAT for nicotine dependence and the mechanisms and     effects posited to mediate MBAT's impact on abstinence.   "
187931|NCT00297492|"     This study tests whether stopping smoking by gradually cutting down first is more or less     successful than stopping abruptly. We hypothesize that stopping by gradually cutting down     first will produce more abstinence than stopping abruptly.   "
187932|NCT00297505|"     The purpose of this study is to compare the effects of citalopram versus placebo given in the     context of contingency management for cocaine dependence.   "
187933|NCT00297518|"     This study is to determine whether scaling and root planning (SRP) followed by photodynamic     disinfection results in improved outcomes that persist over time in adults with chronic     periodontitis when compared with subjects with SRP alone.   "
187934|NCT00297531|"     This study is to determine whether scaling and root planing (SRP) followed by photodynamic     disinfection results in improved outcomes that persist over time in adults with chronic     periodontitis when compared with subjects with SRP alone.   "
187935|NCT00297544|"     We are investigating the chronic effect of daily assumption of Viagra on the blood vessels     function in patients with impotence. The study will include 2 groups: 1- patients with     multiple risk factors, e.g. hypertension 2- patients with no cardiovascular risk factors   "
187936|NCT00297557|"     Comparison of single time point with dual time point PET imaging in the accuracy of     diagnosing active lymphoma. Biopsy results or clinical/radiological progression will be used     in conjunction with the PET data.   "
187937|NCT00297570|"     The study is controlled and randomized in Philadelphia-positive chronic myeloid leukemia (Ph+     CML) patients with complete cytogenetic response after more than one year of imatinib     therapy. The aim is to explore a possible benefit in the addition of peg-interferon (Peg-IFN)     to imatinib, in terms of the rate of achievement, molecular remission, and response duration.   "
187960|NCT00298285|"     The primary aim is to determine the rate of major bleeding and blood clots when using     enoxaparin as a bridge to oral blood thinning medication in patients who have undergone     mechanical valve replacement.   "
187961|NCT00298298|"     To determine if a vaccine made from patient's own tumor tissue can stimulate an immune     response against the patient's tumor cells. To determine the safety of the vaccine   "
187938|NCT00297583|"     The primary objective of the study was to compare the effect of insulin glulisine, insulin     lispro and unmodified human insulin on endogenous glucose production during euglycemic     glucose clamps using stable labeled glucose in type 1 diabetic subjects.      The secondary objectives of the study were to assess:        -  the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma          nonesterified free fatty acids (NEFA) and glycerol levels        -  the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma          lactate levels        -  the safety and tolerability of insulin glulisine in comparison to insulin lispro and          unmodified human insulin.   "
187939|NCT00297596|"     This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second     line therapy in patients with stage IV, metastatic breast cancer   "
187940|NCT00297609|"     Computerized physician order entry with clinical decision support system CPOE+CDSS)completely     eliminated errors in filling in the resuscitation medications order forms and significantly     reduced time to completing the forms in a pediatric critical care department (PCCD).   "
187941|NCT00297635|"     This study will help determine whether the use of a wireless glucose meter and and an     internet-based automated diabetes management system to organize blood glucose values will     help improve glucose control during the start of continuous subcutaneous insulin infusion     therapy by an insulin pump device in patients with type 1 diabetes. Outcome measures to be     determined include an assessment of glucose excursions, overall glucose control, health care     team staff and patient time required and a satisfaction survey.   "
187945|NCT00298090|"     Measuring tissue oxygen saturation (St02) in the thenar eminence is emerging as a measurement     of resuscitation. However, no study to our knowledge has evaluated the effects of an arterial     line in the radial artery supplying this muscle bed on St02. This study will attempt to     address the interaction between an arterial line and St02 monitoring in the thenar eminence.     As most patients who require aggressive resuscitation will have an arterial line, it is     important to understand what if any impact this will have on St02 in the same extremity.   "
187946|NCT00298103|"     The purpose of this study is to review patients with E. coli infections at UPMC from January     1, 2004 to December 31, 2005 to determine if these infections have arisen in the community     rather than in hospitals or nursing homes. The occurrence of such resistant isolates could be     devastating if they were associated with bloodstream infection, such as sometimes accompanies     urinary tract infection, since antibiotic resistant E. coli is not suspected in isolates     coming from the community.   "
187947|NCT00298116|"     The overall hypothesis to be tested is: women with the molecular phenotype of highly skewed X     chromosome inactivation are at increased risk of spontaneous abortion.   "
187948|NCT00298129|"     Many patients with chronic renal disease show a loss of the nocturnal decline of blood     pressure (non-dipper). However, the mechanism is not yet fully understood. We evaluate     24-hour blood pressure in patients with chronic renal disease using an ambulatory blood     pressure monitoring device (A & D TM2425). We also analyze the power spectrum of heart rate     variability as an index of autonomic cardiovascular modulation using the same device.   "
187949|NCT00298142|"     The management of headache disorders is too often based upon trial and error or on personal     beliefs and opinions. Seldom it is based on scientific arguments. Therefore the     identification of prognostic patient characteristics is mandatory as this will lead to a more     precise referral of headache patients.A prospective cohortstudy is designed to identify these     prognostic patient characteristics. After testing, 186 headache patients (migraine, tension     type headache and cervicogenic headache) will be randomly allocated to one of two treatment     groups. Testing includes the fulfillment of questionnaires (Headache Diagnosis Questionnaire,     Headache Inventory Questionnaire and the Headache Impact Test) and physical tests (Thermal     Stimuli, Cervical Spine examination and Pressure Algometry). Treatment groups are a usual     care group (administered by a medical doctor) and a usual care plus physio-/ manual therapy     treatment. After six weeks of treatment subjects will complete the headache inventory list     and the Headache Impact Test a second time. The perceived effect will be registered allowing     the distinction between responders (positive effect) and non-responders (no effect or worse).     Logistic regression-analysis will be used to identify the specific patient characteristics of     the responders and the non-responders. Secondly the additional value of the physio-/ manual     therapy intervention will be examined. Follow-up measurements up to 52 weeks are provided.   "
187950|NCT00298155|"     Prostate cancer (CaP) is the most commonly diagnosed cancer among males in the U.S. and the     second leading cause of cancer-related mortality. More than 230,000 men will be diagnosed     with prostate cancer in the USA this year and more than 30,000 will die of this disease.      Androgen deprivation, the elimination of testosterone and its active metabolites, remains the     single most effective intervention available for the treatment of advanced prostate     carcinoma. This is usually achieved by surgical removal of the testes (orchiectomy), by     suppressing production of testosterone (LHRH agonists) and/or by blocking the androgens at     receptor sites (antiandrogens). Unfortunately, androgen suppression does not cure the     disease. Most patients progress within 0-5 years, and all patients ultimately progress if the     cancer is not eliminated during initial therapy (usually prostatectomy or radiation).      Hormone suppression treatment eliminates the detectable levels of testosterone in the blood.     However, the testosterone levels in tissue remain high enough to stimulate androgen     receptors. Overexpression of androgen receptors is present in all cell lines which     demonstrate androgen independence, i.e., are resistant to androgen-suppressive therapy.      Approximately 95% of testosterone is supplied by the testes, with the remaining 5% supplied     by the adrenal glands. The presumption that standard androgen deprivation achieves the     optimal level of androgen suppression for patients is based on the levels of androgen which     result from orchiectomy. However, because adrenal androgen levels are unaffected by standard     modes of androgen deprivation, 5% of the body's testosterone remains despite hormone therapy.      The hypothesis of this study is that more effective suppression of the androgen axis through     elimination of adrenal androgens and more effective suppression of testosterone metabolites     will lower intraprostatic androgen levels, minimizing activation of the androgen receptor and     augmenting natural cell death (apoptosis). The investigators propose to test this hypothesis     by administering neoadjuvant (pre-surgery) androgen deprivation therapy of different types     before prostatectomy for patients with clinically localized prostate cancer. The     investigators will assay serum and intraprostatic androgen levels, while assessing relative     levels of apoptosis of normal and malignant tissue.   "
187962|NCT00298311|"     The objective of this study is to examine the impact of a home-based peer support     intervention for mothers affected by postpartum depression (PPD) and for their infants.   "
187951|NCT00298168|"     Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced     kidney injury and resultant delayed graft function (DGF). PSGL-1 is a ligand for P-, E-, and     L-selectin. It has been reported that YSPSL (rPSGL-Ig) blocks P-selectin and, to a lesser     degree, E- and L-selectin. Both sPSGL-1 and YSPSL (rPSGL-Ig) have been shown in animal models     to reduce both cytokines and tissue damage associated with ischemia reperfusion and to     improve renal function post-transplant. Therefore, the current phase I/II clinical study is     designed to assess the safety and efficacy of YSPSL (rPSGL-Ig) in preventing DGF in patients     undergoing cadaveric kidney transplants and to determine a dose for future pivotal studies.   "
187952|NCT00298181|"     Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced     kidney injury and resultant DGF. PSGL-1 is a ligand for P-, E-, and L-selectin. It has been     reported that that YSPSL (rPSGL-Ig) blocks P-selectin and, to a lesser degree, E- and     L-selectin. Both sPSGL-1 and YSPSL (rPSGL-Ig) have been shown in animal models to reduce both     cytokines and tissue damage associated with ischemia reperfusion and to improve renal     function post-transplant. Therefore, the current phase I/II clinical study is designed to     assess the safety and efficacy of YSPSL (rPSGL-Ig) in preventing DGF in patients undergoing     cadaveric kidney transplants and to determine a dose for future pivotal studies.   "
187953|NCT00298194|"     To assess in subjects with and without functional dyspepsia the effects of Z-338 on:        1. Type and severity of symptoms a standardized nutrient challenge        2. The gastric nutrient distribution and gastric emptying of a standardized nutrient          challenge        3. The association of the above with the manifestations of symptoms and symptom pattern   "
187954|NCT00298207|"     High blood pressure (hypertension) is one the most common and serious chronic diseases among     Americans, especially among the African Americans. The purpose of this study is to explore     the effect six month long walking intervention on blood pressure in adult African American     with a newly diagnosed high blood pressure (hypertension). The hypothesis is that the group     with encouragement to walk extra 30 minutes a day for 5-7 days a week may lower their blood     pressure compared to the control group without the encouragement.   "
187955|NCT00298220|"     The aim of the study is to test whether or not a tailored multi-component intervention     program to increase the activity of general practice teams in the prevention of hazardous and     harmful alcohol consumption results in increase advice giving rate to patient with hazardous     and harmful alcohol consumption and a better patient outcome in terms of hazardous and     harmful alcohol consumption.      The primary objectives of the proposed study are:        1. to test the (cost) effectiveness of a tailored multi-component implementation program to          engage general practices (i.e. GPs, nurse practitioners or practice nurses/assistants)          in the prevention of hazardous or harmful alcohol consumption, changing both providers'          advice giving behaviour and patients' alcohol consumption        2. to identify predictors of effect        3. to examine whether or not the implementation of a tailored multi-component          implementation program to engage general practice in the prevention of hazardous or          harmful alcohol consumption is feasible.   "
187956|NCT00298233|"     Influenza, also known as the flu, is a contagious respiratory illness caused by influenza     viruses. The illness can range in severity, from mild to severe to even death, and it causes     an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years,     there have been increasing numbers of human cases of avian influenza, or bird flu. This trend     may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian     influenza virus that can easily spread from person to person. Oseltamivir is an antiviral     medication that is used to treat people with uncomplicated human influenza, and it may be     effective in treating people with either severe human influenza or avian influenza. The     purpose of this international study is to compare standard-dose oseltamivir versus high-dose     oseltamivir for treating people who are hospitalized with severe human influenza or avian     influenza.   "
187957|NCT00298246|"     The purpose of this study is to learn more about autism and its subtypes. Autism is a     developmental disorder in which children have problems with communication and social skills     and display restricted interests and repetitive behaviors.      This study has several goals. One aim is to look at types of autism that are known, such as     the regressive subtype, (where skills are lost). We will explore whether there is a unique     change in immune functioning related to this subtype. Another aim is to serve as one of the     sites that will pilot a larger natural history study, entitled Autism Phenome Project. The     goal is to further understand autism by identifying other subtypes.      We will look at several types of medical issues that may be related to autism, including     immunologic problems. Children will be followed over the course of several years. We aim to     capture medical problems that may be related to autism as they develop, and study outcomes in     areas such as behavior and language, in order to explore known and new subtypes of autism.      Normally developing children (aged 1) with autism (age 1, and developmental delays other than     autism (age 1), may be eligible for this study.      Depending on each child's study group and age, participants may undergo the following tests     and procedures:      Baseline Visit        -  Medical and developmental history, physical examination, psychological, cognitive and          medical tests to assess symptoms of autism or other developmental disorders, photographs          of the child's face, collection of hair, urine and baby teeth samples. If available,          hair samples from the baby's first haircut and from the biological mother's hair are          also collected.        -  Overnight electroencephalogram (EEG): A special cap with electrodes is placed on the          child's head to measure brain waves (brain electrical activity) while the child sleeps          in the hospital overnight. Healthy volunteers do not undergo this procedure.        -  Magnetic resonance imaging (MRI) scan: The child stays in the scanner, lying still for          10 to 15 minutes at a time. Since it may be difficult for the child to lie still, the          test may be scheduled for a time when the child is likely to be sleepy, or the child may          be sedated.        -  Lumbar puncture (for children in the autism). This test and the MRI may be done under          sedation.      Follow-Up Visits      Follow-up visits are scheduled at different intervals, depending on study group, age and     aspect of the study the child is enrolled in. The visits include a short interview session     with the child's caregiver and assessment of the child's development and behavior. Some of     the assessment measures used during the baseline examination are repeated, including symptoms     ratings, behavioral tests and a blood test. For some children, the final visit will include     repeats of the medical procedures.   "
187958|NCT00298259|"     Background: Fracture of several ribs in more than one place as the result of trauma, leads to     paradoxical movement of the chest wall and ventilatory failure. The mainstay of management in     these patients has traditionally been analgesia and positive pressure ventilation to splint     the chest wall and allow healing of the ribs to begin. However, this management option leads     to prolonged intensive care unit (ICU) stay with increasing complication rates as patients     remain on a ventilator for prolonged periods. Patients often remain on a ventilator for two     to three weeks while waiting for enough rib healing to provide sufficient chest wall     stability to allow the patient to take over all their breathing themselves. Until that time,     patients are at risk of pneumonia and sepsis and other complications. Long term disabilities     which have been reported in these patients include ongoing pain syndromes, inability to     return to work, particularly manual type labour and cosmetic chest wall deformities.      An alternative treatment strategy is to operatively fix the ribs. By fixing the ribs     operatively, the patient no longer requires internal pneumatic stabilization (provided by     mechanical ventilation) and can be weaned from the ventilator within days rather than weeks.     This can potentially lead to earlier discharge from the intensive care unit, and an avoidance     of the multiple complications which arise in the ventilated patient. Rib fixation may also     lead to less pain and deformity, improved mobility in the post injury phase and earlier     return to work.      Hypothesis: that early operative fixation of ribs in patients presenting with flail chest     secondary to trauma will result in less mechanical ventilatory requirements, earlier     discharge from the intensive care unit and lower rate of complications associated with     prolonged mechanical ventilation. This will lead to cost savings in the treatment of these     patients.   "
187963|NCT00298324|"     The purpose of this study is to determine whether the response to treatment for extensive     chronic Graft versus Host Disease (cGvHD)is improved with the addition of myfortic alongside     cyclosporine A and prednisone, compared to the reference treatment of cyclosporine A and     prednisone alone.   "
187964|NCT00298337|"     The aim of the study is to find out if allergic diseases can be prevented buy giving     probiotic bacteria to pregnant mothers and their newborn infants   "
187965|NCT00298350|"     The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137     relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of     combination antiretroviral regimens in subjects who have failed, or are failing, protease     inhibitor therapy.   "
187971|NCT00298428|"     The risk of thrombotic complications after implantation of drug-eluting stents (DES) may be     increased in patients with diabetes mellitus (DM) or metabolic syndrome (MS). It is     recommended that all patients take an association of aspirin and clopidogrel for several     months after DES implantation to reduce this risk. However, the biological efficacy of     current antiplatelet therapies has not been studied prospectively and specifically in DM or     MS patients.      Our aim is to study the biological efficacy of an association of aspirin and clopidogrel (600     mg loading dose followed by 75 mg maintenance dose) using an assay measuring ex vivo     shear-induced platelet aggregation (SIPA), along with other assays measuring platelet     activation and aggregation, in patients with DM, MS, or no DM/MS.      Patients with stable coronary artery disease and successful DES implantation in native     coronary arteries will be eligible. They will be stratified at entry according to their     metabolic status (DM, MS, or no DM/MS). Measurements will be performed 6-24 hours after     clopidogrel loading dose (acute effects) and 4 months later under clopidogrel maintenance     dose (chronic effects).      Study end-points:      A. Primary biological end-point: To compare SIPA levels in DM vs. MS vs. no DM/MS patients.      B. Secondary biological end-points:        -  To compare the results of other tests of platelet aggregation/activation in DM vs. MS          vs. no DM/MS patients.        -  To compare the acute (6-24 hours after clopidogrel loading dose) and chronic (4 months          later) results of the above mentioned tests. These comparisons will be performed in the          overall population and in each group (DM, MS, no DM/MS).      C. Secondary clinical end-points: To study the relationship between SIPA levels (and the     other tests of platelet aggregation/activation) and the occurrence of:        -  Periprocedural myocardial infarctions        -  Major adverse cardiac events (cardiovascular death, myocardial infarction or          ischaemia-driven target vessel revascularization) at 4 and 12 months after stent          implantation.      We, the researchers at Assistance PUBLIQUE - HOPITAUX de Paris, anticipate our study may help     improve our knowledge of the efficacy of current antiplatelet therapies in DM and MS patients     treated with DES.   "
188099|NCT00300118|"     The purpose of this study is to determine whether mesalazine or budesonide is more active in     the treatment of active Crohn's disease.   "
187966|NCT00298363|"     This study was designed to evaluate and compare the safety and tolerability of tenofovir     disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of     hepatitis B patients with decompensated liver disease. Safety was assessed by evaluating     adverse events (AEs) and laboratory abnormalities. Efficacy was assessed by evaluating     reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores,     reductions in hepatitis B virus (HBV) deoxyribonucleic acid (DNA), changes in liver enzymes,     development of drug-resistant mutations, and generation of antibody to virus.      A maximum randomized treatment duration of 168 weeks was planned. Since subjects with     decompensated liver disease were enrolled into this study, it was necessary to provide early     intervention strategies if profound viral suppression was not expeditiously achieved. For     this reason, subjects with a decrease in plasma HBV DNA from baseline of < 2 log_10 copies/mL     and plasma HBV DNA > 10,000 copies/mL (or plasma HBV DNA > 1,000 copies/mL for subjects who     entered the study with HBV DNA < 10,000 copies/mL) at Week 8 had the option to start     open-label FTC/TDF and continue in the study. Subjects with a virologic breakthrough or who     had plasma HBV DNA levels remaining > 400 copies/mL (confirmed) at or after 24 weeks of     treatment could have been unblinded at the investigator's discretion for selection of     alternative anti-HBV therapy that may have included open-label FTC/TDF. If study drug was     permanently discontinued, immediate initiation of another anti-HBV regimen was strongly     recommended.   "
187967|NCT00298376|"     This study aims to determine if there is a link between cow’s milk allergy in infants and     regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance     after 12 month avoiding food and persistent in others.      Cow’s milk allergy is evaluated by basophils activation test, T cells activation test,     specific humoral response (IgA, IgE, IgG) in allergic infants before and after 12 month     avoiding food, before and after low dose milk exposure, before and after oral challenge.      Number and function of regulatory T cells and microflora composition are measured at the same     time.      Allergic infants are compared to age matched control group.   "
187968|NCT00298389|"     Patients with chronic obstructive pulmonary disease (COPD) that have frequent chest     infections are the patients most likely to become worse over time. Why these people are more     susceptible to chest infections is not known. One reason might be that the white cells in     their lungs called macrophages do not work properly. Normally, these cells remove all the     debris inhaled into the lung. This can also include bacteria. In patients with COPD, these     macrophages are not able to remove these particles. The research question addresses why this     happens   "
187969|NCT00298402|"     Cigarette smoking causes an increase in inflammation in the lungs. In about 20% of smokers     this inflammation leads to damage in lungs including making holes in the lung tissue. This     damage can not be repaired and these people find it very difficult to breathe. One of the     problems with this disease called chronic obstructive pulmonary disease, or COPD for short,     is that by the time patients visit their doctor with symptoms, the damage has already been     done. At the moment, there is no way to predict which smokers will go on to develop COPD. The     aim of this research is to look at smokers who breathe normally and use an imaging technique     called a CT scan, to look at their lungs in more detail. Some of these people will have spots     on their scan which may be caused by inflammation. We want to look at the cells at these     spots to see if they make more proteins and enzymes that cause lung damage when compared to     people that do not have these spots. We would then be able to predict which smokers are     likely to develop COPD and treat them early before they have damaged their lungs.   "
187970|NCT00298415|"     The last ASCO recommendations in 2003 for the treatment of a CBNPC of stage IIIB/IV of     elderly people, are to manage a monochemotherapy. Paclitaxel in association with carboplatin     is feasible in elderly patients and the retrospective analysis of two studies of the     comparing SWOG, one this association with that of cisplatine and vinorelbine and the other     cisplatine only with cisplatine and vinorelbine, showed among 117 the 70 years old patients     and more, the absence of significant difference of survival and toxicity compared to the     younger patients. The study recently published of Lilenbaum and Al shows that among patients     with bad PS, association carboplatine and paclitaxel do better than the paclitaxel only. The     paclitaxel managed in weekly form is likely of a better activity by exposing the cancerous     cells in a repeated way with shorter intervals without allowing the emergence of resistant     clones and by allowing an increase in the intensity of amount. This mode of administration     appeared at the same time effective and tolerated very well among patients of more than 70     years. The weekly association of carboplatin and paclitaxel was tested in phase II and showed     a rate of response of 14% and one survival 1 year from 31% a randomized test (not dedicated     to the old person) of phase II to 3 arms was led by Belani et al.. The best combination of     carboplatine + paclitaxel weekly proved to be that associating paclitaxel 100mg/m² 3 weeks     out of 4 and carboplatine AUC 6 in J1 with J1 = J29. A test of phase II dedicated the 70     years old to patients and more was carried out in France taking again this association     carboplatine (AUC 6) every 4 weeks and paclitaxel weekly (90 mg/m² J1, J8 and J15). This test     having included 51 patients highlighted a median of 10,42 months survival (IC 95%:     7,29-17,05)   "
187993|NCT00298714|"     There is evidence on the beneficial effects of the administration of angiotensin II type 1     (AT1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models     of liver fibrosis in rodents and limited information in chronic hepatitis C with mild     fibrosis.      The purpose of this study is to investigate the effect of long-term administration of oral     Losartan, an AT1 receptor antagonist, on liver fibrogenesis in patients with chronic     hepatitis C and fibrosis F2-F3 (METAVIR score).   "
187972|NCT00298441|"     The purpose of this study is to determine whether the frequency of intravenous iron     administration has an effect on anemia correction and oxidative stress formation in     hemodialysis patients.   "
187973|NCT00298454|"     Intensive care patients with multiple organ dysfunction syndrome often show renal failure     with the need for hemofiltration. Resolving renal failure after cessation of hemofiltration     may or may not be accompanied by oliguria. Whether or not the administration of diuretics at     that moment is appropriate is not known. The study randomises between furosemide or placebo     when hemofiltration is stopped. Study endpoint is recovery of renal function.   "
188100|NCT00300131|"     Prospective, open-labeled First in Man Clinical Investigation enrolling patients with     visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x     18 mm BVS EECSS containing 98 microgramme per cm² of surface area.   "
187974|NCT00298467|"     This study is an open-label, fixed-dose, multicenter study of MDX-060 in patients with ALCL     who have relapsed or refractory disease. There will be 3 phases of this study: Induction,     Maintenance, and Follow-up. Patients will be required to attend all protocol-required visits     in the 4-week Induction Phase, in which administration of MDX-060 will occur, as well as     other testing. Patients who complete the Induction Phase may be eligible for additional     MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase. Patients who complete     the Maintenance Phase with a response of stable disease or better will be followed every 2     months for 1 year or until disease progression. The purpose of this study is to determine     objective response rate at Day 50 in patients with relapsed or refractory classic systemic     ALCL or primary cutaneous ALCL treated with MDX-060. Other objectives will be evaluated.   "
187975|NCT00298480|"     Transvaginal ultrasound of the cervix has become a common tool to evaluate patients who are     at risk for preterm delivery. A shortened cervical length has been associated with an     increased risk of preterm delivery. Dynamic cervical change is visible shortening(>6mm) of     the cervix seen during the ultrasound examination. Prior studies have shown that the presence     of dynamic change in patients with a shortened cervical length(<3cm) is not independently     predictive of preterm delivery. However, a subset of patients with normal initial cervical     length(>3cm) and dynamic change did demonstrate an increased rate of preterm delivery.     Because this was a small sub-group, the present study was designed to obtain a larger sample     size for further evaluation. The second focus of this study involves patients with a dilated     cervix and whether cervical length adds predictive value to gestational age at delivery.      Patients presenting to with symptomatic preterm labor(vaginal pressure or uterine     contractions), who consent to the study, will undergo the standard evaluation for preterm     labor(described in detail below.) The only additional evaluation is a prolonged transvaginal     ultrasound of approximately 10 minutes to evaluate for the presence of dynamic change during     a contraction.      Null hypothesis:      Symptomatic preterm labor patients, with normal initial cervical length(>3cm), who exhibit     dynamic cervical change deliver at a gestational age equal to those without dynamic change.      Alternative hypothesis:      Symptomatic preterm labor patients, with normal initial cervical length(>3cm), who exhibit     dynamic cervical change deliver at an earlier gestational age than those without dynamic     change.   "
187976|NCT00298493|"     All critically ill, mechanically ventilated patients in the Intensive Care Unit receive     medications to relieve pain and anxiety. However, accumulation of these medications can be     associated with serious complications, most notably longer time on the breathing machine and     in the ICU. Two strategies have been shown to dramatically improve patient outcomes:     nurse-directed protocols for giving sedation, and daily interruption of sedation. However,     these strategies have not been widely adopted, because of physicians' concerns, and because     it is unclear which strategy is better. Given that patient outcome is improved with either of     these strategies, the fundamental question that arises is whether patients managed with a     combination of two strategies which both reduce drug accumulation (protocolized sedation and     daily interruption) have an even better outcome than patients managed with only one of them     (protocolized sedation). We propose a multicenter study in which 700 critically ill,     mechanically ventilated patients will have their sedation managed with protocolized sedation     alone, or both strategies. Both groups of patients will have the following recorded: ICU and     hospital lengths of stay, mortality, total sedative drug use, ICU human resources used, side     effects and recall of their ICU stay. The results of this large multi-center trial will help     to inform best practice with regard to sedation management of critically ill patients in     Canada and elsewhere. In addition, reducing ICU stay could be economically attractive, as the     cost of an ICU day in Canada is approximately $3000.   "
187977|NCT00298506|"     This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506)     combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.   "
187978|NCT00298519|"     Women of different ethnic groups have different diets that may affect the fatty acid content     of their breast milk. Ethnicity may also have an independent effect on breast milk     composition. The differences in fatty acid content of breast milk may influence the immune     tolerance of breastfed babies, and hence the development of allergy.   "
187979|NCT00298532|"     The OPALS Pediatric Study will examine the incremental impact of introducing a prehospital     full advanced life support in pediatric patients.   "
187994|NCT00298727|"     Purpose: This study will compare the effectiveness and mediators of two different knowledge     transfer (KT) interventions in terms of their impact on changing knowledge and behavior     (utilization and clinical reasoning) related to health outcome measures.   "
187980|NCT00298545|"     The researchers are involved in a research program to understand how vitamin D and calcium in     the diet or as supplements may lower the risk of colorectal polyps and cancer. To that end,     the researchers are conducting a study of vitamin D supplementation in which volunteer     subjects are provided a Western style diet for 2 separate 4 week periods at the Rockefeller     University Hospital. During one of these 4 week inpatient periods, subjects receive calcium     supplements and during the other 4 week inpatient period they receive a placebo tablet. The     researchers determine changes within the colon as a result of supplementing the vitamin D in     the presence of high and low calcium. A more detailed description of the study is provided     below.   "
187981|NCT00298558|"     The purpose of the ACTIVE study was to test if cognitive training interventions could     maintain functional independence in elders by improving basic mental abilities, with     follow-up assessments through five years.   "
187982|NCT00298571|"     The use of .5% Bupivacaine with epinephrine at the time of skin closure in cesarean     deliveries will decrease post-op pain.   "
187983|NCT00298584|"     The purpose of this study is to determine which of the two procedures commonly used to     collect urine, percutaneous suprapubic aspiration (SPA) and urethral catheterization (UC), is     less painful, and the success rates and complication rates associated with both methods.   "
187984|NCT00298597|"     In the study we want to prove whether the subcutaneous application of granulocyte-stimulating     factor (G-CSF) and erythropoetin (EPO) influence associative learning and/or motor skills of     patients, who suffer from chronic stroke or amyotrophic lateral sclerosis. The study     hypothesis is that G-CSF and EPO improve associative learning and/or motor skills.   "
187987|NCT00298636|"     Adenosine A1 and A2 receptors are widely distributed in the brain and spinal cord and     represent a non-opiate target for pain management. Activated spinal A1 receptors inhibit     sensory transmission by inhibiting the slow ventral root potential, which is the     C-fiber-evoked excitatory response associated with nociception. Adenosine may inhibit     intrinsic neurons through an increase in K+ conductance and presynaptic inhibition of sensory     nerve terminals to inhibit the release of substance P and perhaps glutamate. Although     adenosine A3 receptors are not found in the nervous system, adenosine is also known to have     anti-inflammatory properties that may contribute to pain relief in the peripheral setting of     inflammation.   "
187988|NCT00298649|"     The goal of this project is to develop and test the effectiveness of a Lay Health Advisor     program to teach migrant and seasonal farmworkers about pesticide safety in their homes. This     is a community-based collaborative research project in which we first conduct in-depth     interviews with farmworkers to learn about their knowledge and beliefs relative to pesticide     exposure in the home, and, second, develop the content of the Lay Health Advisor program     based on this formative information. We will evaluate this program by conducting pre- and     post-test interviews with farmworkers, and comparing safety and knowledge to a control group     who receive other important health education.   "
187989|NCT00298662|"     The purpose of the study is to evaluate the safety and tolerability of a combination of     interferon beta 1-b (Betaseron®) and tacrolimus (Prograf®) in patients suffering from     multiple sclerosis (MS) who have failed treatment with currently approved drugs for MS      Prograf is an immunosuppressant that weakens the immune reactions responsible to protect the     organism against infections. It is currently available on the market for patients who have     received an organ transplant, to prevent rejection. Because of its effect on the immune     system, theoretically, Prograf should exert a significant effect in MS. It has been tried in     a small number of MS patients at a lower dose than the one used in organ transplant, however     the results of the study did not allow to draw definite conclusions on its safety and     efficacy in MS.      Betaseron is approved in Canada for the reduction of the frequency of relapses in patients     with relapsing-remitting MS and for the slowing of progression and reduction of the frequency     of relapses in patients with secondary-progressive MS. The combination of Betaseron and     Prograf may result in an additive effect or an increase in the actions of the drugs. However,     the combination of the two drugs has never been studied.      The aim of this study is to see how well the combination of Betaseron and Prograf is     tolerated by patients with MS. The side effects of the treatment, if any, will be followed.     In addition, the efficacy of the combination will be evaluated.   "
187990|NCT00298675|"     The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD)     and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects     with histologically documented advanced solid tumors that are refractory to standard therapy     or for which no standard therapy is available. Additionally, the safety and tolerability and     clinical response of BSI-201 + irinotecan will be investigated in patients with metastatic     breast cancer in the phase 1b portion of the study.      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
187991|NCT00298688|"     The purpose of this study is to determine the disease control rate at trial closure and after     the first stage of the study in patients with relapsed or refractory SCLC and measurable     disease treated with gefitinib   "
187992|NCT00298701|"     This trial is performed to assess whether the Grazax-R treatment is safe to use in children     aged 5-12 years.   "
188026|NCT00299169|"     Patients who are intolerant of statins in routine practice, but who lack objective evidence     of significant harm, will be randomized to receive statins by either n of 1 trials or     standard practice. Our hypothesis is that n of 1 trials will improve statin adherence,     thereby improving low density lipoprotein cholesterol (LDL-C) levels.   "
187995|NCT00298740|"     This research is being done to find out whether subjects previously treated with the     implantable insulin pump (IIP) therapy, and now taking insulin by injection, will benefit     from re-implantation of IIP. We will see if IIP causes more stable control of blood sugar,     with fewer highs and lows. People with type 1 diabetes previously implanted with the MiniMed     Implantable Pump (MIP) model 2000 at Johns Hopkins may join this study.   "
187996|NCT00298753|"     Patients treated with the antiepileptic drug Oxcarbazepine often develop syndrome of     inappropriate secretion of antidiuretic hormone(SIADH)We want to test the hypothesis, that     these patients have a higher reabsorption of water during the Aquaporine2 water channels,a     higher concentration of Vasopressine (AVP), and a lower clearance of water.This situation     will tend to normalize, when the patients are treated with fluid restriction   "
187997|NCT00298766|"     This is a phase 1/2 open-label, dose-escalation study investigating single-agent therapy with     VELCADE in patients with previously treated systemic AL-amyloidosis who require further     treatment.   "
187998|NCT00298779|"     This is an open-label, randomized, multiple-dose, multicenter Pharmacokinetics drug-drug     interaction study in patients with advanced solid tumors, including non-Hodgkin's lymphoma,     who are in need of anti-tumor therapy. In addition, the impact of omeprazole on the     pharmacodynamics of VELCADE will also be evaluated.   "
187999|NCT00298792|"     The purpose of this study is to determine if a treatment for alcohol dependence that is     specifically tailored to patients' patterns of drinking and coping strategies can result in     better outcomes than more standardized treatments.   "
188000|NCT00298805|"     The purpose of this study is to compare depressive characteristics in migraine patients to     those observed in patients with epilepsy in a previous study, and determine whether those     symptoms are unique to patients with epilepsy.   "
188001|NCT00298818|"     The purpose of this study is to assess the efficacy and tolerability in real-world clinical     practice, of adjunctive zonisamide treatment in adult patients with developmental     disabilities and epilepsy.   "
188003|NCT00298844|"     The study aim is to establish a consecutive population of newly referred type 2 diabetes     mellitus patients and among these to describe the degree of macrovascular disease by     evaluating left ventricular systolic and diastolic function (echocardiography), myocardial     perfusion (single-photon emission computed tomography (SPECT)), the peripheral vascular     perfusion (strain gauge toe blood pressure measurements and a ultrasound scan of the a.     carotis communis). Further, the degree of microvascular disease will be evaluated (glomerular     filtration rate assessment, fundus photography and biotesiometry). Finally the cohort will be     followed the next two years to assess the prognostic value of the above-mentioned parameters   "
188004|NCT00298857|"     The purpose of this study is to compare the blood levels of valproic acid in subjects with     different body weights and to evaluate whether the pharmacokinetic parameters of this drug is     altered in the obese population.   "
188005|NCT00298870|"     The purpose of this study is to elucidate whether the individualized medicine based on NAT2     gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug     therapy for the pulmonary tuberculosis with isoniazid.   "
188006|NCT00298883|"     Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal     transplantation.   "
188007|NCT00298896|"     The purpose of this study is to evaluate the objective tumor response rate to SNS-595 in     patients with small cell lung cancer (SCLC).   "
188008|NCT00298909|"     The investigators want to study the relative effects of physical exercise vs.     extended-release niacin (lipid-lowering drug) in patients with coronary heart disease and low     HDL cholesterol (good cholesterol) on        -  lipid profile        -  endothelial function as measured by ultrasound      The endothelium is the inner part of the blood vessels. Impaired endothelial function is     known to be associated with atherosclerosis which can ultimately lead to diseases such as     stroke, heart attack and others. Endothelial function can be assessed non-invasively by     ultrasound.      Both interventions mentioned above have been shown to have a beneficial effect on lipid     profile and endothelial function. However, the relative effects are unclear.   "
188009|NCT00298922|"     Pulmonary infection with Burkholderia cepacia complex (BCC) in patients with CF is often     associated with a more rapid decline in lung function. Because of the resistance of BCC to     many antibiotics, treatment options are often limited. New therapies to improve outcomes for     patients infected with BCC are needed.      However, because of the unpredictable nature of this pulmonary infection in CF, patients with     BCC infection have been excluded from many CF therapeutic trials.      Recent published trials in the United States, Australia, and the United Kingdom have all     demonstrated clinical benefits from prolonged administration of azithromycin in CF. In these     trials, the vast majority of patients were chronically infected with Pseudomonas aeruginosa.      Patients with BCC were excluded from the US and UK trials, and only four patients with BCC     infection were enrolled in the Australian trial. Thus, the effectiveness of azithromycin in     CF patients infected with BCC is largely unknown and deserves further study.      The two main ways by which azithromycin is thought to help with the chronic lung infections     seen in CF are by [a] reducing inflammation and [b] direct effects on the bacteria, in     particular P. aeruginosa. BCC pulmonary infection in CF is often associated with a large     inflammatory response similar to or more severe than P. aeruginosa infection. If azithromycin     works mainly by an anti-inflammatory mechanism, it should also be helpful in CF patients     infected with BCC.      Alternatively, azithromycin could have a direct effect on BCC as seen with P. aeruginosa as     the two bacteria have many similarities.   "
188010|NCT00298935|"     The purpose of this study is to determine whether osteopathic manipulative treatment (OMT):        -  decreases pain and improves physical functioning in women during the third trimester of          pregnancy        -  decreases complications during obstetrical delivery        -  improves quality of life in the post-partum period   "
188736|NCT00321477|"     This is a Phase IIa study to evaluate the efficacy, safety and tolerability of GW679769 vs     placebo on symptoms of urgency with urge incontinence, frequency and nocturia associated with     overactive bladder in women.   "
188011|NCT00298961|"     In our study we will aim to examine the issues of cost analysis, quality of life, clinical     efficacy and satisfaction of psychiatric consultations through videoconference in a primary     care setting in comparison with in-person psychiatric treatment and primary care only. The     main hypotheses of the study are: Satisfaction of the patients will increase, the use of     telepsychiatry will reduce the costs for the primary and mental health care centers as well     as for the patients, the treatment will be as effective as in-person treatment, the number of     patients referred to mental health treatment will be higher than that of the previous year,     quality of life will improve and that there will be a stigma reduction of mental illness.   "
188012|NCT00298974|"     The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR     to placebo in subjects with osteoarthritis (OA) of the hip or knee.   "
188013|NCT00298987|"     The purpose of this clinical research study is to provide dasatinib treatment to patients     with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute     lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The     safety of the treatment will also be studied.   "
188014|NCT00299000|"     The purpose of the study is to evaluate the safety and efficacy of two dose levels of     Naglazyme in infants under the age of one year who have MPS VI by monitoring physical     appearance, x-ray of the skeletal system and growth.   "
188015|NCT00299013|"     The purpose of this study is to investigate whether a novel dosage form of a prednisolone     ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.   "
188016|NCT00299026|"     The clinical investigation is an international, prospective, double-blind, randomized safety     and efficacy study. The purpose of this study is to evaluate the safety and performance of     the NIRx(TM) Paclitaxel-Coated Stent (1.0µg/mm2 of paclitaxel incorporated into slow- and     moderate-release formulation of a triblock copolymer carrier system)in patients who present     for stenting of de novo lesions of a native coronary artery.   "
188017|NCT00299039|"     Current standard of care for post-operative analgesia after breast surgery in CDHA is Tylenol     #3® (300 mg acetaminophen, 30 mg codeine, 15 mg caffeine per tablet). We are proposing to     test the analgesic efficacy of acetaminophen plus ibuprofen against Tylenol #3® in patients     undergoing outpatient breast surgery.   "
188018|NCT00299052|"     The Tibia bone (shinbone) is located in the leg, itis the most frequently fractured bone in     the body and has very poor blood supply because it is surrounded by skin and fat instead of     muscle like the thighbone causing healing problems. Problems frequently found during the     healing process are malunion (bone heals in the wrong place), nonunion (the bone never     heals), and compartment syndrome (a big inflammation of muscle that causes compression of     nerves and blood vessels) with necrosis (death) of tissue. Surgeons have tried to decrease     these problems by using different surgical techniques and substances to accelerate healing.     Substances frequently used in fractures are bone grafts. Bone grafts are normally obtained     from the wrist or the hip bone, and sometimes can cause other complications varying from pain     to infection. To avoid complications, investigators have used alternatives such as obtaining     bone from donors. The donor bone grafts are carefully analyzed and cleaned to ensure they     will not cause problems for the receiver. Bone obtained from donors is called Demineralized     Bone Matrix (DBM). DBM has proved to be very effective in helping fractures to heal faster     and we want to use it in patients with tibia fractures.      This study is important because DBM can improve the way tibia fractures are treated and could     have the potential to decrease the time patients must stay in the hospital. DBM could improve     healing time and diminish overall costs. Also, with the use of DBM plus reamings, patients     will have fewer complications like pain and infection.   "
188019|NCT00299065|"     The prevalence of asthma continues to increase. Despite the large number of available     therapies, many patients continue to require emergency deparment (ED) visits and intensive     therapy. However, ED visits continue to be a major contributor to the healthcare cost of     asthma treatment. In the United States alone, asthma is the 11th most common reason for ED     visits, with ED visits and hospitalizations accounting for almost 50% of the healthcare cost     for asthma. Additionally, while only 20% of asthmatics have had ED visits or     hospitalizations, these patients account for over 80% of the direct costs for asthma     treatment. Current National Asthma Education and Prevention Program (NAEPP) guidelines     regarding management of acute asthma exacerbations in the ED setting include: oxygenation for     most patients, inhaled short-acting β2-agonists and systemic corticosteroids.      Zileuton, a specific 5-lipoxygenase inhibitor, has been extensively studied in inflammatory     diseases such as asthma, which involve leukotrienes as mediators of inflammation. Zileuton     Immediate Release (IR) tablets (Zyflo®) were approved by the Food and Drug Administration     (FDA) in December 1996 for the prevention and treatment of asthma in adults and children 12     years of age and older. The results of the 2 pivotal studies in asthmatics with zileuton IR     tablets demonstrated that zileuton at a dose of 600 mg QID produced and maintained a lasting     improvement of lung function. In addition to the lasting effect of zileuton, an acute     bronchodilation (as early as 60 minutes) was observed after administration of the first 600     mg oral dose.      This acute bronchodilator effect may benefit patients during an acute exacerbation of asthma     when added to the usual care in the ED or clinic setting. Critical Therapeutics has developed     an injectable formulation of zileuton that will be explored for use in acute asthma     exacerbations. This initial study is intended to provide PK data, information on safety and     tolerability and some indication of pharmacologic activity as evidenced by lung function     changes. In an attempt to enhance the potential for observing effects on lung function, only     those patients with a demonstrated ability to respond by an increase in FEV1 of at least 10%     within 3 hours after oral zileuton dosing will be enrolled.   "
188020|NCT00299091|"     This is a study on the utility of the modification of doses of efavirenz guided by its plasma     concentration (therapeutic drug monitoring) in HIV-infected patients initiating treatment     with Sustiva.   "
188021|NCT00299104|"     This is a phase III, randomized, controlled, double-blind, parallel group, international     study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to     Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be     enrolled and will be allocated equally between 3 treatment arms.   "
188022|NCT00299117|"     The primary purpose of this study is to examine the effect of a brief preoperative smoking     intervention on postoperative complications in women undergoing breast cancer surgery.      Secondary purposes are to examine long-term smoking cessation rates and experienced stress     and nicotine withdrawal symptoms during the smoking cessation period.   "
188023|NCT00299130|"     This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid     arthritis (RA).   "
188024|NCT00299143|"     The purpose of this study is to determine whether shear-induced platelet aggregation is able     to discriminate first acute coronary syndrome (ACS) from recurrent ACS   "
188025|NCT00299156|"     The goal of this clinical research study is to learn if clofarabine given by mouth on a     weekly schedule can help to control MDS. The safety of clofarabine given by mouth will also     be studied.   "
188027|NCT00299182|"     The goal of this clinical research study is to find the highest safe dose of AMG 531 that can     be given to treat thrombocytopenia (low platelet counts) in patients who have received     chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531.      Primary Objectives:        1. To determine the clinical safety and tolerability of AMG 531 administered following          chemotherapy (R-HyperCVAD alternating with R-Ara-C/MTX) in patients with non-Hodgkin's          lymphoma.        2. To determine an optimal biologic dose (OBD) of AMG 531 in patients receiving R-HyperCVAD          and R-Ara-C/MTX.        3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and          platelet recovery following chemotherapy(chemo).      Secondary Objectives:      1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route with     chemotherapy.   "
188028|NCT00299195|"     The purpose of this study is to see if a drug called sulindac can prevent the development of     changes in the mouth that are related to oral pre-cancer growths (oral epithelial dysplasia)     or oral cancer. Sulindac is an anti-inflammatory drug that has already been tested in people     with arthritis (inflammation of a joint).      This study is being done by Memorial Sloan-Kettering Cancer Center in New York, Amrita     Institute of Medical Sciences and Research Center in Cochin, India, and Regional Cancer     Centre (RCC) in Trivandrum, India.   "
188029|NCT00299208|"     The goal of this study is to develop a safe, well tolerated, and highly efficacious     azithromycin combination treatment for uncomplicated falciparum malaria. Azithromycin is a     drug that has shown potential for malaria treatment. It will be combined with other malaria     drugs currently approved for treatment in Thailand. About 120 people, ages 20-65, will be     enrolled in Thailand. Participants will have severe cases of malaria and they will be     hospitalized 28 days for treatment.   "
188030|NCT00299221|"     This was a study to compare less intense immunosuppression with a more traditional approach.     The hypothesis was that less immunosuppression will provide similar protection against     rejection than typical 2-3 drug therapy.   "
188101|NCT00300157|"     The purpose of this study is to determine whether percutaneous coronary angioplasty with     Taxus drug eluting stent is safe and effective in the treatment of unprotected left main     coronary artery disease associated to other coronary lesions or not.   "
188031|NCT00299234|"     This study is a double-blind, placebo-controlled, parallel group trial of atomoxetine (1.8     mg/kg) for the management of chemotherapy-related acquired attentional disorders in children     who have survived Acute Lymphocytic Leukemia. Atomoxetine will produce a favorable impact on     ADHD symptoms in children with chemo-related acquired attentional disorders.   "
188032|NCT00299247|"     The purpose of this study is to study resistance to current malaria treatments and affordable     alternatives for uncomplicated malaria. Resistance occurs in areas where these treatments are     used frequently. This study may help prevent future resistance. About 150 residents in     Buenaventura, Colombia will participate. They will have uncomplicated malaria and they will     be followed for 28 days after treatment. Physical exams and blood draws are included in study     visits.   "
188033|NCT00299260|"     Patients who receive transplants are at increased risk of developing serious cytomegalovirus     (CMV) infections because they have a decreased immune system. The purpose of this study is to     evaluate the safety and immune response of a CMV vaccine in patients (18 years old and older)     who are awaiting a transplant. Following immunization with vaccine or placebo (inactive     substance), patients will be followed for the development of immune responses to CMV and for     evidence of CMV infection following transplantation. One hundred forty eligible patients will     receive 3 injections of the CMV gB vaccine or 3 doses of placebo during 5 visits.     Participants will participate in the study for approximately 7 months (if they do not undergo     a transplant) or 10 months (if they undergo a transplant).   "
188034|NCT00299273|"     The purpose of this study is to examine the effects of a low calorie high fat/protein diet on     body fat and body composition in overweight and obese subjects. The investigators will also     test the effects of this diet on secondary outcomes such as: fluid and electrolyte balance,     cholesterol, inflammation, sugar and insulin metabolism, fat hormones, blood pressure and     feelings of fullness.   "
188035|NCT00299286|"     To provide an in vivo measure of the activity of lapatinib. To assess the antiproliferative     effects of lapatinib in breast cancer, ie how much lapatinib slows down the growth of cancer     cells by measuring K167 (a marker of proliferation) in breast tumours before and after a     short treatment with lapatinib.   "
188036|NCT00299299|"     This study tests the feasibility and reproducibility of patient-specific motion models. These     will be used for quantification of safe margin reduction. Patient-specific motion models will     be built by post-processing 4D MRI data with non-rigid registration. By comparing these     models between visits, model reproducibility will be assessed, and the methodology refined.   "
188037|NCT00299312|"     Rett Syndrome (RTT) is a genetic brain disorder that occurs almost exclusively in females and     is usually caused by a change (mutation) in the gene MECP2. The disorder is characterized by     multiple developmental problems, as well as behavioral features, such as repetitive     stereotypic hand movements, including hand washing, wringing, and tapping. While there is no     cure for RTT, recent advances in the understanding of the disease suggest that the     development of new, effective therapies is promising. This study will gather information on     the genetic defects that cause RTT, the physical expressions of these defects, and disease     progression. In turn, this may direct the development of future treatments. Expanded studies     include individuals with MECP2 Duplication disorder, and RTT-related disorders including     individuals with MECP2 mutations, but not meeting obligatory criteria for the diagnosis of     RTT and individuals with mutations in CDKL5 and FOXG1 some of whom meet criteria for atypical     RTT.   "
188052|NCT00299507|"     The purpose of this study was to evaluate the effect of the dose concentration and     administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size     when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months     (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).   "
188053|NCT00299520|"     This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive     either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the     first four days of study treatment and then every other day, for up to 14 days of the     treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment),     and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).   "
188054|NCT00299533|"     We are studying whether the addition of fish oil capsules, containing 2.2 gm of     polyunsaturated fatty acids, when added to antiepileptic drugs improve seizure control.   "
188038|NCT00299325|"     Primary objective:      To assess the effect of rimonabant on visceral fat area over a period of 12 months when     prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome      Secondary objectives:        -  To assess the effect of rimonabant over a period of 12 months on:             -  Liver fat content using CT scan (Computed Tomography scan)             -  Anthropometric measures (weight, waist circumference, body composition using Dual               Energy X-ray Absorptiometry (DEXA))             -  Lipid, lipoprotein profile             -  Glycemia, insulinemia and HbA1c             -  Adipokines, inflammatory and hemostatic markers        -  To evaluate the percentage of patients with metabolic syndrome at 12 months        -  To evaluate the safety and tolerability of rimonabant in these patients      In four selected US sites the effect of rimonabant at 12 months will be also assessed on:        -  Basal lipolysis and insulin suppressed lipolysis (euglycemic hyperinsulinemic clamp).        -  Resting metabolic rate and substrate oxidation at rest using indirect calorimetry.        -  Adipose tissue histology and expression of genes involved in glucose and lipid          metabolism (superficial adipose tissue biopsy).   "
188039|NCT00299338|"     This a Phase I/II non-randomized, open-label clinical study of 8 weeks duration using SP01A     in HIV positive patients on a stable antiretroviral regimen. Dose response and safety     associated with oral administration of four doses (200 mg, 400 mg, 600 mg, and 800 mg daily)     of SP01A will be studied in a total of 24 study subjects. In addition, six HIV-negative     subjects will be recruited as a control for cortisol secretion only and will not receive     study medication.   "
188040|NCT00299351|"     To evaluate the safety and tolerability of extended treatment with depsipeptide in patients     who have at least demonstrated stable disease on prior Gloucester-sponsored depsipeptide     clinical trials, and in the opinion of their physician/ investigator might benefit from     continued treatment with depsipeptide   "
188488|NCT00310817|"     To compare the functional immune response 28 days after administration of one dose of Men     ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY     polysaccharide (PS) vaccine   "
188041|NCT00299364|"     The benefit-risk-balance of the isopropanolic Cimicifuga racemosa extract (iCR) is compared     with tibolone in menopausal symptoms treatment. Menopausal patients aged 40 - 60 years and     with a Kupperman Menopause Index (KMI) equal or more than 15 participate and were assigned to     either iCR corresponding to 40 mg crude drug/day (n=122) or tibolone 2,5 mg/day (n=122)     orally. The primary endpoint is the benefit-risk balance at end of treatment.   "
188042|NCT00299377|"     Randomized comparison of abciximab i.v. versus i.c. in patients with STEMI undergoing primary     PCI. The hypothesis is, that higher concentration of abciximab i.c. leads to improved     epicardial flow, perfusion, reduction of no-reflow, reduction in infarct size and     subsequently better outcome.   "
188043|NCT00299390|"     The purpose of this study is to determine whether the study drug is effective and safe in the     first line treatment of patients with small cell lung cancer   "
188044|NCT00299403|"     The aim of the present study is to compare the antidepressant effect of electroconvulsive     therapy ( ECT) with that of low frequency repetitive transcranial magnetic stimulation of the     right prefrontal cortex.      In the same study we investigate the value of saliva cortisol as a predictor of treatment     outcome.   "
188045|NCT00299416|"     Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2     glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two     hour while being cooled to 34.5 C.   "
188046|NCT00299429|"     Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally     invasive bypass surgery in patients with isolated proximal left anterior descending coronary     arteries in terms of non-inferiority of an end point combining mortality, acute myocardial     infarction and rate of reintervention of the target vessel within one year.   "
188047|NCT00299442|"     This project will introduce a self-help parent training programme for families on National     Health Service (NHS) waiting lists for child mental health services. It will examine whether     access to treatment can be increased by providing an intervention that requires fewer     resources and by releasing clinician time for more serious cases. This intervention will be     tested in a randomised, controlled trial in which 35 subjects will receive treatment     immediately and 35 will receive treatment after waiting for 10 weeks. All families will also     complete questionnaires before and after the 10 week study period in order to measure changes     in child behaviour, parenting, and parental mental health. Cost-effectiveness of this     programme will also be analysed. Intention-to-treat analyses will be conducted.   "
188048|NCT00299455|"     This is a prospective, randomized, double-blind, placebo controlled one-center study carried     out in primary care setting of the health center of City of Turku, Finland. The study     patients will be allocated to one of the two parallel treatment groups     (amoxicillin-clavulanate or placebo). The hypothesis is that the symptoms and signs of acute     otitis media are resolved more effectively with antimicrobial treatment than with placebo.     Furthermore, this study aims at finding out prognostic factors that could help to direct     antimicrobial treatment for correct subgroups of young patients.   "
188049|NCT00299468|"     We will test - in a chronically ill managed long term care population - the effectiveness of     an intervention that provides nurse Care Managers with an inventory of evidence-based     practices tailored to patients with different levels of knowledge, skills and confidence to     engage in self-care management. Specifically, we will develop a change package of     evidence-based hypertension (HTN) management strategies geared to patients scoring at the     four different stages of activation on the Patient Activation Measure (PAM). We will randomly     assign a group of interdisciplinary teams in the managed long-term care plan to intervention     or control status and will train the Care Managers on the Intervention teams to use the     change package in conjunction with a patient's PAM score to design - with the involvement of     the patient - an individualized HTN management plan. We then will assess the impact of the     intervention on patient activation and outcomes.   "
188050|NCT00299481|"     The purpose of this study is to create a tissue bank of gynecologic cancers and normal tissue     for the study of cancer in order to better understand the changes occurring on a molecular     level (DNA, RNA, protein) that lead to the development of cancer.   "
188051|NCT00299494|"     The purpose of the study is to determine the tolerability, the initial safety profile and     maximum tolerated dose, and to obtain preliminary information on the antitumor activity of     inotuzumab ozogamicin [CMC-544] in combination with rituximab in subjects with follicular,     diffuse large B-Cell, or mantle cell NHL.   "
188055|NCT00299546|"     The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in     subjects who have active rheumatoid arthritis and have been treated previously with at least     1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).   "
188056|NCT00299559|"     The purpose of the study is to determine whether the application form of etheric oils     (camphor, cineol and menthol) causes changes in the concentration of this agents in the     exhaled air. The second aim of the study is to determine differences in the subjective     convenience of the application forms. We will test an commercial ointment application vs.     smart textiles. Smart textiles are new high-tech products with the unique possibility to     combine the textiles with functional products e.g. pharmaceutical agents.   "
188057|NCT00299572|"     Hyperphosphatemia is frequently seen in patients with end-stage renal disease (ESRD).     Hyperphosphatemia usually results in a high calcium-phosphorus product (CPP) which may     subsequently lead to artery and become a risk factor of cardiovascular complications.     Alendronate, due to its effect of inhibiting osteoclasts, is approved for treatment of     osteoporosis. Previous reports found the use of bisphosphonates could suppress arterial     calcification in hemodialysis dialysis patients. The aim of this study is to evaluate the     safety and efficacy of alendronate to suppress coronary artery and aortic calcifications, as     well as to improve bone density in chronic peritoneal dialysis (PD) patients.      This study will include ESRD patients who had received maintenance PD for more than 3 months,     have high CPP level (≧55), and have chest X-ray proven aortic calcification or coronary     artery calcification. All participants are randomly allocated to either group 1 or group 2.     Group 1 patients receive alendronate 70 mg once weekly in the first 16 weeks, while group 2     patients receive the same dose of drug every week in the second 16 weeks. The extent of     coronary artery and aortic calcification is evaluated by using multi-detector spiral computed     tomography, whereas bone mineral density is measured by dual-energy X-ray absorptiometry.     Both examinations are performed at week 0, 16 and 32 for each participant. Laboratory studies     and possible adverse reactions were regularly monitored.      We expect that alendronate can alleviate the progression of arterial calcification or even     improve it. Bone density may also be improved after treatment. Besides, we wish to find the     independent factor(s) influencing the efficacy of alendronate. These results may help     clinical physicians for early intervention and prevention of cardiovascular complications in     ESRD patients.   "
188058|NCT00299585|"     Objective: The evaluation of PD VitalOs Cement, an injectable brushite, as a stabilizer of     dental implants and a potential source for bone augmentation.      Methods: Forty (40) patients needing dental implants will be treated where needed with PD     VitalOs Cement gapping half of their sites whereas the other half will be gapped with Bio-oss     demineralized bone and BioGuide membrane.   "
188059|NCT00299598|"     Resin composites withholding antibacterial properties may be useful in preventing recurrent     caries. Covalently attached antibacterial polymers are a possible solution.This in vivo study     would evaluated the antibacterial effect of alkylated polyethylenimine nanoparticles     incorporated into flowable and hybrid composite resin disks embedded in a palatal removable     appliance.The disks would be in close contact with the palate in order to check for contact     mucosities. disks on the side facing the Tongue would be evaluated for their antibacterial     potency with confocal laser scanning microscopy.   "
188060|NCT00299611|"     The purpose of this study is to evaluate the effectiveness of Levetiracetam augmentation     relative to Placebo in SSRI non-remitters with obsessive compulsive disorder. The hypothesis     is that anxiolytic effect of Levetiracetam is more beneficial when adding with a SSRI.   "
188061|NCT00299624|"     Aging is an independent risk factor, without any clear explanation. The primary aim of the     study is to depict the effect of aging on the coagulation fibrinolysis parameters and     microparticles.   "
188062|NCT00299637|"     This study will try to determine whether fetuses to mothers having clinical chorioamnionitis     have changes in blood flow in middle cerebral artery.   "
188063|NCT00299650|"     The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively     investigated. The aim of the study is to show a reduction of the mortality rate of ARDS     patients.   "
188064|NCT00299663|"     Group A streptococcus (GAS) causes a variety of human infections. It is also an uncommon but     serious cause of postpartum infections. In contrast to group B streptococcus (GBS) infection,     which causes illness and death in newborns disproportionately more often than it does in     mothers, perinatal GAS infection primarily affects mothers . Invasive GAS infection is     defined by the isolation of GAS from a normally sterile site (e.g., blood) or by the     isolation of GAS from a nonsterile site in the presence of the streptococcal toxic shock     syndrome or necrotizing fasciitis. A postpartum case of invasive GAS is defined as isolation     of GAS during the postpartum period, in association with a clinical postpartum infection     (e.g., endometritis) or from either a sterile site or a wound infection.      Because of the burden and severity of invasive GAS infection, the Centers for Disease Control     and Prevention (CDC) hosted a meeting in to formulate guidelines for responding to postpartum     and postsurgical GAS infections. However, we could not find any recommendations for long-term     follow-up of patients who had GAS infection subsequent to delivery or gynaecological     procedures, or further recommendations regarding subsequent delivery or gynaecological     invasive procedures. It is possible that women who had GAS as a cause of vaginal infection     may have a tendency to be carriers of this organism, but this has never been proven. We     believe it is of importance to determine if women who have had one infection may be long-term     carriers which may pose a risk during future pregnancies.      The objective of the present study is to evaluate the incidence of long term gynaecological     carrier state of patients who had GAS invasive infection following delivery, and to provide     guidelines for follow-up and treatment of such patients.      The proposed study may answer the question whether this endogenous GAS origin represents     chronic GAS carrier state, similar to the known GBS carrier state. As some of these patients     had severe infections (sometimes life threatening) a protocol for long-term follow up and     management is necessary in case an invasive procedure is done (IUD insertion, endometrial     biopsy, curettage or delivery) in order to prevent recurrent infection. The information     collected in the study will enable us to afford recommendations for follow up and prophylaxis     in the future.   "
188065|NCT00299676|"     The purpose of this observational study is to investigate the changes in cognitive     functioning, behavior, and functional improvement in Alzheimer's disease patients treated     with Galantamine who are living at home (i.e. not in permanent residential care), and to     obtain information regarding usual clinical practice that can be used for communicating     treatment expectations to patients and supporters.   "
188066|NCT00299689|"     The purpose of this study is to determine whether ONTAK is an effective treatment in patients     with Stage IV Melanoma   "
188067|NCT00299702|"     The purpose of this study is to compare the effectiveness of two antipsychotic medications,     RisperdalÂ® ConstaÂ® versus AbilifyÂ®, over a 2-year treatment period in the long-term     maintenance of patients with schizophrenia.   "
188068|NCT00299715|"     The purpose of this study is to evaluate the effectiveness and safety of 3 different doses of     paliperidone extended release (ER) compared to placebo in patients diagnosed with Bipolar I     Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate     the effects of paliperidone extended release on global functioning, and the relationship     between blood levels and the effectiveness and safety of paliperidone.   "
188137|NCT00307398|"     A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg     or sham administration every 6 months.   "
188737|NCT00321490|"     This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and     safe in the treatment of patients with MDD.   "
188069|NCT00299728|"     This is a phase I, open-label, randomized study of NY-ESO-l protein with immune adjuvants CpG     7909 and Montanide® ISA-51 and NY-ESO-l protein 400µg with immune adjuvants CpG 7909 and     Montanide® ISA-51 in patients with tumors that often express NY-ESO-1.      The vaccinations will be administered subcutaneously every 3 weeks for 4 doses.      Patients with any malignancy that is known to frequently express NY-ESO-1 will be eligible,     regardless of whether antigen expression in the autologous tumor can be demonstrated or not     by either PCR or immunohistochemistry.      The primary objective of the study is to define the safety.      Secondarily, the study will evaluate whether patients develop a specific immunologic response     to the NY-ESO-1 protein. Blood samples will be obtained at baseline, prior to each     vaccination, one week after each vaccination, and at the last study visit for the assessment     of NY-ESO-1 specific CD4+ and CD8+ T-cells. Cytokine secretion by NY-ESO-1 specific CD8+ and     CD4+ T-cells, as a measure of T-cell activation, will be determined by FACS analysis. In     addition, humoral immunity will be determined by the presence of NY-ESO-1 specific antibodies     which will be assessed in all patients by ELISA.      Disease status will be assessed at baseline and 2-4 weeks after the fourth vaccination in     patients with evaluable (measurable and non-measurable disease).   "
188102|NCT00300170|"     This study is to look at things that may affect whether or not people who are HIV-infected     get into medical care and stay in medical care. some of the things that will be examined     include how drug use, HIV disease severity, mental health, housing, trust, feelings of     discrimination, social support, relationship with provider, and patient's race and provider's     race are linked with whether or not people get health care. People who are enrolled in the     study will be interviewed once, and their medical records will be examined.   "
188070|NCT00299741|"     -  There are nearly 30,000 deaths per year in the United States from prostate cancer,          making this a large and important target patient population for new cancer treatments.        -  SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or          more specifically receptor tyrosine kinases, in tumor cells. These proteins are active          in cellular pathways that are important for development and growth of a variety of          different cancers. The targets of SU011248 include the receptors for vascular          endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and others. By          blocking the VEGF and PDGF pathways, SU011248 can induce death of the blood vessels that          nourish the cancer cells and death of the cancer cells themselves.        -  SU011248 has demonstrated significant anti-tumor activity in renal cell carcinoma,          gastrointestinal stromal tumors, and other cancers. Its effect against prostate cancer          has not been studied to date.        -  This study is directed at two populations of men with advanced prostate cancer:             1. Men with advanced prostate cancer who have a rising PSA despite hormone therapy,               but have not yet received any chemotherapy.             2. Men with metastatic prostate cancer who have received prior chemotherapy (with a               docetaxel-based regimen) and have increasing disease following chemotherapy.        -  Men in this study will receive SU011248 on a six-week repeating schedule, with four          weeks of daily treatment followed by a two-week rest. The goals of the study are:             1. to determine whether SU011248 is an important therapeutic agent in men with               advanced prostate cancer, and             2. to identify predictive markers of anti-cancer activity within individual subjects               that would allow selective treatment of appropriate subjects in the future.   "
188071|NCT00299754|"     Most studies of labour induction with misoprostol used doses higher than 25mg and intervals     of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as     single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg     dinoprostone pessary.   "
188072|NCT00299767|"     The purpose of this study is to determine the safety of sequential cord blood transplantation     (2 cord blood units) for patients who have diseases that are capable of being cured by     allogeneic stem cell transplant but do not have a matched family or volunteer unrelated     donor.   "
188073|NCT00299780|"     The purpose of this study is to determine the safety of parathyroid hormone in combination     with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize     sufficient progenitor stem cells after one or two attempts.   "
188074|NCT00299793|"     The purpose of this study is to assess efficacy, safety and tolerability of lamotrigine as     used in a natural clinical setting, to examine the positive effects of lamotrigine, and the     reasons why some patients choose to continue or discontinue lamotrigine.   "
188075|NCT00299806|"     Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe     hypertension   "
188076|NCT00299819|"     The primary objective of this study is to evaluate the safety and tolerability of     intravenously administered MEDI-545 compared with placebo, over a dose escalation range of     0.3-30 mg/kg, in adult patients with SLE and who are receiving 20 mg/day or less of     prednisone orally or an equivalent dose of another oral corticosteroid.   "
188077|NCT00299832|"     Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in     hypertensive patients with renal dysfunction   "
188078|NCT00299845|"     Proton pump inhibitors are administered to children as off-label use in Japan. The purpose of     this study is to evaluate the effects of CYP2C19 genotypes on pharmacokinetic     /pharmacodynamic profiles of PPI in children. The results will provide the beneficial     information for the individualized medicine of PPI in children.   "
188079|NCT00299858|"     This will be a prospective randomized double-blinded parallel group clinical trial evaluating     the short-term effects of theophylline therapy on exercise duration and lung function in     patients with chronic obstructive pulmonary disease already receiving both tiotropium and a     long-acting beta-agonist (salmeterol or formoterol).   "
188080|NCT00299871|"     To evaluate the dose-response relationship of AVE0010 administered once daily and twice daily     with chronic dosing in metformin-treated subjects with type 2 diabetes   "
188081|NCT00299884|"     The primary aim of this study is to evaluate the efficacy and non-inferiority of a     lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate     taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (LDL-C)     cholesterol. Additionally, other aims would include effects on other types of blood     cholesterol and examining the safety of the ezetimibe and fenofibrate regimen, as compared to     atorvastatin.   "
188082|NCT00299897|"     This is a 28-day, multi-center, placebo-controlled study designed to look at the dose     response, efficacy, and safety of SP01A, given as a pill to be swallowed, in the treatment of     HIV-infected subjects.      Samaritan has discovered that SP01A affects cholesterol binding, which is directly implicated     in the pathogenesis of HIV. It has also been established that drugs of this nature exert an     anti-HIV effect in-vitro. These data suggest that SP01A has the potential to reduce HIV virus     replication.      One measurement of an HIV infected person’s risk of progressing to AIDS is the number of     viral particles of HIV in their blood (called a “viral load”). This study is designed to see     if SP01A will lower the amount of HIV in an infected individual's blood. Patients will be     assigned by chance to 1 of 4 groups. Neither the patient nor the study doctor or nurse will     know which dose of the study drug the patient is taking or if he/she is receiving the placebo     (a capsule that looks like the study drug but does not contain any active ingredient).      Study drug administration will continue for 28 days. At the end of the 28-day study, the     patient will be offered testing of his/her virus for resistance to approved drugs (genotype).   "
188083|NCT00299910|"     This study will assess in a double blind placebo controlled fashion the effects of a 12 week     course of oral montelukast/placebo on polysomnographic and radiological findings and will     characterize the systemic (serum,urine) and local (upper airway collected biological samples)     inflammatory response in children (2-10 years of age) with sleep disordered breathing,     fittingthe inclusion and exclusion criteria.   "
188084|NCT00299923|"     The aim of this study is, to compare the relapse rate in chronic HCV patients with genotype 1     or 3 under the combination of standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a),     Ribavirin (RBV) and Amantadine (AMA) given for 72 weeks (group A), versus the same     combination, given for 48 weeks (group B) in patients who relapsed to previous combination     therapy to conventional or pegylated (PEG) Interferon alfa and Ribavirin. Relapse ist defined     as percentage of patients with non-detectable HCV-RNA at end of therapy (week 48 GT1/ week 24     GT 3) who become HCV-RNA positive during a follow-up period of 24 weeks.   "
188085|NCT00299936|"     The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of     rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects   "
188086|NCT00299949|"     Sepsis is the 13th most common cause of death in the United States, causing approximately     210,000 deaths per year. Once DIC has developed, irreversible organ injury has already     occurred and the mortality rate is 70%. Inhibition of systemic coagulation with activated     protein C concentrate has been the only therapy for sepsis introduced in the past several     decades which has improved outcomes. Elucidation of the coagulopathic mechanisms early in the     development of DIC may give rise to targeted therapies and strategies for early intervention.     We hypothesize that an increase in endogenous thrombin potential precedes the development of     overt DIC by a clinically significant time period. Our primary objective is to determine if     endogenous thrombin potential (ETP) measured at first diagnosis of sepsis prior to the onset     of DIC and organ failure is predictive of overt DIC and/or poor outcome. We will compare ETP     to standard coagulation assays and the clinical assessment of DIC using the ISTH criteria for     overt DIC. A secondary objective of this study is to determine if host coagulation variables     predispose to the development of DIC and poor clinical outcome during sepsis.   "
188087|NCT00299962|"     This Phase I study will evaluate the safety of two doses of BG00001 at different doses and     intervals. Eligible subjects will have:        -  malignant pleural mesothelioma, or        -  pleural effusions who have progressed through at least one prior therapy or have refused          therapy      BG00001 is given twice through a catheter in the pleural space.   "
188088|NCT00299975|"     Functional constipation (FC) is common with 14.3% estimated prevalence in Hong Kong, but     treatment for this condition in conventional medicine is suboptimal. Complementary and     alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by     patients with FC, but there is little research evidence about these commonly used CHM. The     purpose of the study is evaluate the efficacy and safety of CHM, as well as determining the     optimal dosage.   "
188089|NCT00299988|"     The overall goal of this double-blind Phase II study is to evaluate the safety, efficacy and     biological mechanisms of action of Intravenous Immunoglobulin (IVIg) in the treatment of mild     to moderate stage Alzheimer's disease (AD). IVIg contains antibodies against the amyloid beta     protein that is the central component of the AD senile plaque. It is hypothesized that IVIg     treatment will reduce the levels of beta amyloid in the brain and improve cognitive abilities     relative to placebo. A total of 24 patients with mild to moderate AD capable of giving     informed consent will be randomly assigned to receive either IVIg (16 patients)or saline     placebo (8 patients) for six months. This study includes comparison of four dosing regimens     of IVIg. Cognitive, behavioral and functional measures will be collected at baseline, three     months and six months of treatment. Plasma samples will be collected before and after     infusions. Subjects will undergo a lumbar puncture before and after the six months of     treatment for cerebrospinal fluid (CSF) biomarker analyses. In addition, Positron Emission     Tomography (PET) imaging substudies will be performed at two time points during the study.     Following the initial 6 month placebo-controlled period, all participants have the     opportunity to receive IVIg for an additional 12 month period in an extension study.   "
188090|NCT00300001|"     The primary research objective of this protocol is to evaluate the impact of integrating a     home-based symptom monitoring system in the day-to-day care of cancer patients in community     settings on the frequency of supportive symptom interventions, symptom severity, and quality     of life.   "
188091|NCT00300014|"     The Purpose of this study is compare the efficacy of intravitreal triamcinolone in clearing     recurrent post-vitrectomy diabetic hemorrhage with conventional treatment, air-fluid     exchange.   "
188092|NCT00300027|"     The purpose of this study is to define the recommended dose of BMS-582664 that could be     safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil,     leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced     gastrointestinal malignancies and to evaluate the safety profile, tolerability,     pharmacokinetics (PK) and pharmacodynamics (PD) of these combinations.   "
188093|NCT00300040|"     The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing     adequate wound healing in patients with severe peripheral vascular disease who are undergoing     lower limb amputation.      The hypothesis is that HBOC-201 will pass through the partially occluded lesions in the     peripheral arteries in the lower extremity and promote the wound healing process by     delivering oxygen to the oxygen deprived tissues. This will reduce the incidence of lower     limb wound complications at 60 days post-surgery and may reduce the incidence of a second     amputation.   "
188094|NCT00300053|"     The purpose of this study is to evaluate the efficacy and safety of intramyocardial     injections of adult stem cells in patients with refractory chronic myocardial ischemia.   "
188095|NCT00300066|"     The purpose of this study is to assess serum cystatin C as a marker of kidney function     (glomerular filtration rate, GFR) in children aged 2-14. The individual production rate and     possible extra renal elimination of cystatin C based on body composition data is included to     develop new algorithms to estimate GFR.      Furthermore, day-to-day variation on serum cystatin C is investigated.   "
188096|NCT00300079|"     This is a multiple-dose study of the IOP-lowering efficacy of Azopt (brinzolamide) 1.0%     compared to timolol 0.5% when added to a prostaglandin analogue (PGA) as adjunctive therapy     over a 24 hour period in patients with glaucoma or ocular hypertension.   "
188097|NCT00300092|"     Study objective: Fingertip injuries are common in the pediatric population. Considerable     controversy exists about whether prophylactic antibiotics are necessary after repair of such     injuries. Our goals were to estimate the rate of bacterial infection among pediatric patients     with distal fingertip injuries overall and to compare the rate of bacterial infections among     subgroups treated with and without prophylactic antibiotics.      Methods: This was prospective randomized control study of pediatric patients presenting to an     urban children's hospital with trauma to the distal fingertip requiring repair. Patients were     randomized to two groups: those receiving prophylactic antibiotics (Cephalexin) and those who     did not receive antibiotic therapy. Repairs were performed in a standardized fashion and all     patients were re-evaluated in the same emergency department in 48 hours and by phone 7 days     later. The primary outcome of this study was the incidence of infection.   "
188098|NCT00300105|"     This is a parallel-group, multi-center, long-term extension study from the GALLANT 4 study to     monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in     patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including     treatment and follow-up, is 103 weeks.   "
188103|NCT00300183|"     This study evaluates outreach to HIV-infected people living in unstable housing in New York     City who are new to CitiWide Harm Reduction. One hundred and fifty people are interviewed     every 6 months, and their medical records are reviewed every 6 months for a total of 18     months. The study examines how outreach, case management, housing, drug use, mental health,     and quality of life are related to people's ability to get into and stay in medical care.   "
188104|NCT00300196|"     The primary purpose of this study is to determine whether a brief intravenous infusion of     ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.   "
188105|NCT00300209|"     Description: The Manhattan HIV/Hepatology Brain Bank (MHBB) was established in 1998 as a     resource for the AIDS research community. The MHBB was created to act as a center for the     provision of pre- and post-mortem tissues and body fluids from HIV infected persons. It has     recently expanded its goals to assist in the elucidation of liver disease-induced nervous     system disorders.      The MHBB is dedicated to improving the understanding of HIV and Hepatitis C and thereby,     improving the lives of patients living with HIV and/or Hepatitis C.      Participation is voluntary and can be stopped at any time.      Benefits: This is an observational study; no experimental procedures, devices or drugs are     used. All enrolled patients undergo regular examinations by physicians, nurses, and     neuropsychologists who specialize in the problems that HIV and HCV can cause.      Taking part in this study may result in the detection of brain, muscle, or spinal cord     disease for which treatments may be available. Participants may receive no direct benefit     from this study. However, knowledge gained from this research may, in the future, help others     who suffer from HIV/AIDS and/or liver disease.      Participants agree to autopsy and organ donation upon demise by signing an Anatomical Gift     Consent document.   "
188106|NCT00300222|"     The purpose of the study is to assess the efficacy and safety of NGX-4010 applied for 60     minutes for the treatment of postherpetic neuralgia (PHN).   "
188107|NCT00300235|"     Priapism, a prolonged erection of the penis, is a medical issue that often affects men with     sickle cell disease. The purpose of this study is to collect demographic and clinical     information on priapism by interviewing men with sickle cell disease.   "
188108|NCT00300248|"     Acute lung injury/acute respiratory distress syndrome (ALI/ARDS) is a severe lung condition     that causes respiratory failure. Individuals with ALI/ARDS often require the use of a     respirator or artificial breathing machine, known as a mechanical ventilator, while in an     intensive care unit (ICU). Past research has shown that improved short-term clinical outcomes     result from the use of a protective mechanical ventilation technique for the lungs. This     study will evaluate the effects of lower tidal volume ventilation, and other aspects of     critical illness and ICU care, on the long-term clinical outcomes of individuals with     ALI/ARDS.   "
188109|NCT00300261|"     We are testing the use of telehealth technology that includes self monitoring of blood     pressure, weight, blood sugar, and oxygen levels for patients with heart failure who are     receiving home care. We are interested to learn if using the equipment results in improved     self care and decreased incidence of rehospitalization.   "
188110|NCT00300274|"     This trial was to examine the impact of everolimus and reduced dose of cyclosporine on     efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in     heart transplant recipients.   "
188111|NCT00300287|"     This study is not being conducted in the United States. Key long-term clinical studies have     shown that people with type 2 diabetes should try to achieve overall blood glucose levels as     close to normal as possible. The purpose of this study is to gather data on the long-term     safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering     overall blood glucose levels in people with type 2 diabetes who have not been previously     treated with drug therapy to lower their blood sugar and whose blood glucose levels are close     to normal.   "
188138|NCT00307411|"     Investigating the effect of low dose growth hormone therapy on body fat composition, insulin     sensitivity and metabolic profiles in middle-aged men with metabolic syndrome and low     insulin-like growth factor (IGF-1) level.   "
188112|NCT00300300|"     ACL reconstruction in the Division of Orthopaedic surgery at Queen's is currently being     performed arthroscopically assisted. The resultant function of the reconstructed ligament is     greatly influenced by the placement of the transosseous tunnels, which are tunnels in the     bones through which the grafts pass. Presently the placement of the tunnels is being judged     from arthroscopically identified anatomical landmarks within the joint. The result is     incidence rates of misplaced tunnels as high as 40%. Computer assisted tunnel placement would     aid in the correction and reproducibility of anatomic tunnel placement. The objective of this     study is to conduct a prospective, randomized trial comparing clinical and radiographic     outcomes in subjects who receive either a patella or hamstring tendon graft to reconstruct a     chronic tear of the anterior cruciate ligament. All subjects will be further randomized into     a computer-assisted or a conventional arthroscopic surgical group to allow investigators to     compare the precision and accuracy of tunnel placement between these surgical approaches. The     main question under investigation is: does the increased accuracy of computer-assisted     surgery make a clinical difference to the laxity of the reconstructed knee, and is the laxity     further influenced by the type of tendon graft received?   "
188113|NCT00300313|"     Assessing the efficacy of escitalopram in preventing the development of PTSD, or or reducing     its severeness, after exposure to a traumatic event.   "
188114|NCT00300326|"     To determine clinical outcomes and biomechanical gait performance of patients who receive the     Zimmer Legacy® LPS Flex Knee system using a computer-assisted surgical technique. This study     will provide evidence as to whether there are differences between the two surgical procedures     with respect to complications such as infection and dislocations, rate and level of     functional recovery, blood loss, operating time, degree of radiographic correction and     quality and duration of post-operative pain and stiffness.   "
188115|NCT00300339|"     To investigate in patients suffering from intermittent claudication due to Fontaine stage II     PAD whether a 24-week treatment by SL650472 OD on top of clopidogrel may result in an     improvement of walking capacity, by comparing three doses of SL650472 to placebo, and to     calibrate such effect versus cilostazol   "
188116|NCT00300352|"     We seek to examine the effects of folic acid treatment on vascular function in patients with     coronary artery disease. Our hypothesis is that folic acid treatment will improve vascular     function   "
188117|NCT00300365|"     We will test our primary hypothesis that combining niacin extended release (niacin-ER), at a     daily dosage of up to 2.0 g with pioglitazone, at a daily dosage of 45 mg will result in a     12% greater increase in HDL-C when compared to niacin-ER monotherapy over 12 weeks in     non-diabetic patients with the metabolic syndrome (see Table 1).   "
188118|NCT00300378|"     The primary objective is to compare the antidepressant efficacy, safety, and tolerability of     DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives     include testing both general and functional quality-of-life outcomes and satisfaction with     therapy reported by the subject.   "
188119|NCT00300391|"     The purpose of this study is to determine if treating delirious intensive care unit patients     with haloperidol improves mortality.   "
188120|NCT00300404|"     We investigate whether the add-on specific antitoxoplasmatic medication has positive effects     in individuals with schizophrenia or major depression seropositive for Toxoplasma gondii (TG)     infection. As TG modulates neurotransmitter metabolism affecting serotonin and dopamine we     hypothesize that this chronic persistent infection might play a role for depressive and     psychotic symptomatology. Therefore, on the basis of an ex juvantibus approach, specific anti     TG medication might further improve psychiatric symptomatology in affected patients. This is     investigated in a double-blind, placebo-controlled, randomized treatment trial.   "
188121|NCT00300417|"     This study will test the safety of an experimental vaccine for preventing West Nile virus     infection. The virus is spread mainly by mosquito bites. Symptoms can include high fever,     headache, neck stiffness, stupor, muscle weakness, vision loss, numbness and paralysis.     Rarely, infection leads to permanent nerve damage and possibly death. The vaccine used in the     study is made from DNA that codes for West Nile virus proteins. Injected into a muscle, the     DNA instructs the body to make a small amount of West Nile virus protein. This study will see     if the body creates resistance or immunity to these proteins. Participants cannot get West     Nile virus from the vaccine.      Healthy normal volunteers between 18 and 65 years of age may be eligible for this study.     Candidates are screened with a medical history, physical examination, and blood and urine     tests for various infections and other medical problems. Women who are able to become     pregnant are given a pregnancy test. Women who are pregnant or breastfeeding may not     participate. Anyone who has received a vaccination for Yellow Fever or Japanese Encephalitis     virus in the past may not participate in this research study.      Participants will receive three injections of the experimental vaccine, the first on the     first study day (Day 0), the second on Day 28, and the third on Day 56. The injections are     given with a device called Biojector® (Registered Trademark) 2000 that delivers the vaccine     through the skin into the muscle without the use of a needle. On the day of each injection,     subjects are given a diary card to take home for recording their temperature and any symptoms     or side effects for 5 days. They return to the clinic 2 weeks after each injection, bringing     the completed card with them at that time. In addition to the injections, subjects have the     following tests and procedures during clinic visits:        -  Medical history and, if needed, physical examination: Day 0 and weeks 2, 4, 6, 8, 10,          12, 24 and 32        -  Vital signs and weight: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32        -  Lymph node exam: Day 0 and weeks 2, 4, 6, 8, 10, and 12        -  Blood samples: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32        -  Pregnancy test (for women): Day 0 and weeks 4, 8 and 32        -  Urine sample: Day 0 and weeks 2, 4, 6, 8, and 10      The blood and urine tests are for health checks. Some blood samples are also used to study     the immune response to the vaccine and for gene testing.   "
188122|NCT00300430|"     The primary purpose of this study is to test the safety and the effects of using an     investigational drug regimen; once daily ABT-335 (Investigational drug) administered in     combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in     patients with abnormal lipid levels in the blood.   "
188123|NCT00300443|"     The purpose of this study is to assess the safety and efficacy of bimatoprost in patients     with glaucoma or ocular hypertension   "
188124|NCT00300456|"     The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335)     + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with     multiple abnormal lipid levels in the blood.   "
188125|NCT00300469|"     The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335)     + atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with     multiple abnormal lipid levels in the blood.   "
188126|NCT00300482|"     The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335)     + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy     in subjects with multiple abnormal lipid levels in the blood.   "
188139|NCT00307424|"     AutoCPAP would lead to better compliance than FixCPAP   "
188127|NCT00300495|"     Atrial fibrillation is a very common complication of pulmonary resection. Patients who     develop atrial fibrillation require additional treatment and are more likely to stay in the     hospital for longer period of time increasing the costs associated with the operation. We     propose a randomized controlled trial to see if oral amiodarone given for one week before     surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the     incidence of atrial fibrillation in patients who received preoperative amiodarone and compare     them to the incidence of atrial fibrillation in patients who did not received preoperative     amiodarone.   "
188128|NCT00300508|"     The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an     untreated control group after initial 5 years of adjuvant hormone-therapy.   "
188129|NCT00300521|"     Previous rather poor results in liver transplantation (LT) of patients with advanced     hepatocellular carcinoma (HCC) have made the application of LT very limited in treatment of     HCC. The advantages of ADV-TK gene therapy highlight its potentiality as adjuvant treatment     for HCC patients after LT. We reported here the improved outcome of LT with combined     treatment of ADV-TK gene therapy in patients with intermediate or advanced HCC.   "
188130|NCT00300534|"     The performance of an investigational immunochromatographic strip (ICS) test for the     diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study     population consists of patients with and without syphilis presenting to sexually transmitted     disease clinics in five cities in the United States. Specimens include finger-stick whole     blood (investigational test only) and whole blood, plasma, and serum by venipuncture.   "
188131|NCT00300547|"     The purpose of this study is to diagnose possible synchronous carcinomas and polyps with     magnetic resonance (MR) colonography in patients booked for operation because of carcinoma in     the descending or sigmoid colon, where a preoperative full colonoscopy is not possible. Two     days before colonography, patients ingest a 200 ml Barium sulfate solution four times a day,     which will render fecal masses invisible on the following MR colonography. The study is     primarily a feasibility study with altered operative strategy as a secondary end-point. Gold     standard is colonoscopy and operation.   "
188175|NCT00308321|"     Parallel group double blind randomised in patients with first episode corticosteroid     sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a     longer tapering steroid regimen with standard regime   "
188132|NCT00307307|"     The primary objective of this randomized, double blind, placebo controlled pilot study is to     determine if therapies aimed at lowering LDL cholesterol (HMGCoA reductase inhibitor –     simvastatin) or increasing HDL cholesterol (Niaspan) will induce regression of carotid     atherosclerotic plaque in vivo using MRI imaging techniques. MR plaque morphology at baseline     will be compared to that after 6 and 12 months of therapy and changes in MR characteristics     will be compared to changes in lipoprotein parameters and urinary isoprostanes. The effect of     moderate LDL reduction, aggressive LDL reduction and the combination of aggressive LDL     reduction and HDL elevation on MRI plaque characteristics will be compared by randomly     assigning subjects (n=69) with carotid disease (>30% stenosis by ultrasound criteria) to one     of three treatment arms;        1. Simvastatin 20 mg daily and placebo Niaspan (n=23)        2. Simvastatin 80 mg daily and placebo Niaspan (n=23)        3. Simvastatin 20 mg daily and active Niaspan (n=23) Treatment group 2 and 3 will have          roughly equivalent LDL lowering because of the synergistic LDL lowering effect of the          combination of simvastatin and Niaspan.   "
188133|NCT00307320|"     Researchers at UVa Health System are interested in how women experience and deal with stress     during pregnancy. Participants will be randomly assigned either to engage in coping     strategies on one's own or to receive 6 weeks of relaxation training. Researchers will     examine how coping strategies affect the course of the pregnancy and the health of the infant   "
188134|NCT00307333|"     Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC)     will require intubation and mechanical ventilation as a result of sepsis and sepsis-like     illness.      Infants will be randomly assigned to one of two groups. One group of infants will have the     HRC index known to the physicians caring for them, and physicians will use the HRC index as     they desire to aid in clinical management.      Infants in the other group will have the HRC index recorded, but this information will not be     displayed to the physicians caring for the infants.   "
188135|NCT00307346|"     This study will compare electroencephalograph (EEG) recordings in healthy volunteers and in     people with movement disorders to examine brain activity associated with the weakness. EEG     records the electrical activity of the brain (brain waves).      Healthy volunteers and patients with arm or leg weakness who are between 18 and 80 years of     age may be eligible for this study. Healthy subjects are screened with a medical history,     physical and neurological examinations, and a questionnaire. They must be right-handed and     never have had a neurological disease or head trauma.      All participants have an EEG. An elastic cap with electrodes is placed on the subject's scalp     to record the brain's electrical activity. During the EEG, subjects are required to resist     against a force with their arm, elbow, shoulder or leg for as long as they can. Several     recordings are done with short breaks between them.   "
188136|NCT00307385|"     This study will examine whether hand movement in stroke patients can be improved by applying     electrical stimulation to the side of the brain affected by the stroke. It will compare the     effects of similar brain stimulations in stroke patients and healthy volunteers.      Healthy, right-handed normal volunteers and stroke patients between 18 and 80 years of age     may be eligible for this study. Patients' stroke must have occurred at least 3 months before     entering the study and affect one side of the brain only. Candidates are screened with a     medical history, brain MRI, and evaluation of memory and attention span. Pregnant women are     excluded from the study.      The study involves seven 2-day sessions over the course of about 8 weeks, with each session     separated by at least 1 week. During each session participants practice a pattern of hand     movements and their accuracy in performing the movements is evaluated before and after brain     electrical stimulation. The movements include a complex finger sequence, a simple finger     sequence, a peg test (placing wooden pegs in holes on a board), a hand function test (turning     over cards, picking up small objects with one hand and placing them in a can, picking up     small objects with a spoon and placing them in a can, stacking checkers, moving light cans,     and moving heavy cans), and a box and block test (picking up and moving blocks from one box     to another).      The first day of each 2-day session lasts about 5 hours and includes the following:        -  TMS measurements: A wire coil is held on the scalp, and a brief electrical current is          passed through the coil, creating a magnetic pulse that stimulates the brain. During the          stimulation, the subject may be asked to tense certain muscles slightly or perform other          simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg,          and the subject may hear a click and feel a pulling sensation on the skin under the          coil.        -  tDCS: Small, wet sponge electrodes are applied to the head - one above the eye and the          other on the back of the head. A small electrical current is passed between them. The          subject may feel an itching or tingling sensation under the electrodes or see light          flashes. Some sessions are done with sham tDCS.        -  Motor learning under tDCS: tDCS is repeated while the subject performs different finger          movements. A new pattern of finger movements is taught each session.        -  Surface electromyography: Electrodes are filed with a conductive gel and taped to the          skin over one small hand muscle to measure the electrical activity of muscles.        -  Behavioral measurements: Evaluation of learned movement tasks        -  Questionnaires to evaluate the subject's attention, fatigue and mood before and after          testing      The second day of each session lasts about 2 hours and includes the TMS measurements and     behavior measurements.   "
188141|NCT00307450|"     The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced     dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with     levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the     modified AIMS.   "
188142|NCT00307463|"     This study aims mainly to investigate the effects of two approaches to control blood pressure     in hypertensive hemodialysis patients; using antihypertensive drugs versus strict volume     control (by strict dietary salt restriction and persistent ultrafiltration) without using     antihypertensive drugs on cardiac structure and inflammation.   "
188143|NCT00307476|"     Primary: To determine the effectiveness of the rectal trumpet compared to the standard care     in maintaining skin integrity in patients with fecal incontinence.      Hypothesis (H1): There will be no difference in the failure rates of rectal area skin     integrity between subjects receiving the rectal trumpet and those receiving treatment as     usual (staqndard care).      Secondary: To determine the ease of use, cost-effectiveness, and level of patient comfort     with the rectal trumpet compared to the standard care in patients with fecal incontinence.      Secondary (exploratory) hypotheses:      There will be differences in the ease of use of the devices, costs of the devices, and     patient comfort relative to the devices.   "
188161|NCT00308139|"     A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of     Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with     Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic     Medications.   "
188162|NCT00308152|"     Colonoscopy and sedation are frequently accompanied by hypotension, which reduces the amount     of sedation able to be employed. Blood pressure is restored by the infusion of intravenous     normal saline. Prophylactic infusion of normal saline may enhance the colonoscopy completion     rate, and patient comfort during colonoscopy and during the recovery from colonoscopy.      The investigators propose randomising consenting adult patients attending outpatient     colonoscopy to one of two treatment arms:      (i) A control arm      (ii) A treatment arm, with pre-hydration with an infusion of 1.0 litre of normal saline     immediately prior to colonoscopy.      Outcome measures include colonoscopy completion rates, hypotension during or after     colonoscopy, and patient ratings of comfort and satisfaction.   "
188144|NCT00307489|"     This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once     daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg     (FTC/TDF) once daily in subjects currently being treated with adefovir dipivoxil (Hepsera)     for chronic hepatitis B who have persistent viral replication (detectable hepatitis B virus     deoxyribonucleic acid [HBV DNA]).      Subjects with confirmed (within 4 weeks) plasma HBV DNA ≥ 400 copies/mL during double blind     treatment at Week 24 or any time thereafter have the option of receiving 12 weeks of     open-label FTC/TDF which may be continued through the end of the 168-week treatment period if     there is a virologic response (HBV DNA < 400 copies/mL). Alternatively, subjects with     confirmed HBV DNA < 400 copies/mL at or any time after Week 24 of double-blind treatment may     continue blinded therapy up to Week 168 at the discretion of the investigator. If, in the     investigator's opinion, it is felt that continued blinded treatment beyond 24 weeks in     subjects with confirmed HBV DNA ≥ 400 copies/mL is not beneficial, the subject may     discontinue the study and begin commercially available HBV therapy rather than initiate     open-label FTC/TDF.   "
188145|NCT00307502|"     The purpose of this study is to characterise the pharmacokinetic profiles of non-nucleoside     analog reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs), and the     influence of the individual characteristics on the pharmacokinetic parameters in the Spanish     population of HIV-infected subjects.   "
188146|NCT00307515|"     A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical     practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or     intra-abdominal surgery.   "
188147|NCT00307528|"     As the licensed Pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the     safety and the immune response of the new investigational pneumococcal protein vaccine is     evaluated in healthy elderly population.   "
188148|NCT00307541|"     Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one     month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months     of age   "
188149|NCT00307554|"     Evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals'     10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar.   "
188150|NCT00307567|"     Booster and immune memory study   "
188151|NCT00307580|"     This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at     ~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional CVADs     (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports)     were to be treated with up to two serially instilled doses of Cathflo Activase.   "
188152|NCT00307593|"     The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of     relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated     vasculitides.   "
188153|NCT00307606|"     Background Seroma formation is a common problem after mastectomy. The incidence various     between 30% to 92%. It is often an ongoing problem after removal of the suction drain, and     repeated skin puncture is necessary to remove the seroma. In addition to many ambulatory     visits this also leads to an increased risk of infection, and the adjuvant treatment can be     delayed for several weeks      Different procedures have been tried to avoid seroma formation. Among these are for ex. :     immobilisation of the arm and shoulder after mastectomy, different drain regimens, closing of     the dead space of the cavity, different chemical substances as thrombin, tranexamacid and     fibrin. Non of these results has been successful.      Seroma formation is most likely the result of the inflammatory response due to wound healing.     In the seroma fluid several factors have been detected that support this assumption. These     factors are: high levels of IgG, leucocytes, granulocytes, proteinases, proteinases     inhibitors, different kinds of cytokines ( tPA, uPA,, uPAR, PAI-1, PAI-2, IL-6 og IL-1).      On the basis of this, an inhibition of the inflammatory response might result in a decrease     of seroma formation, and perhaps improve quality of life after mastectomy.      Steroids inhibit the inflammatory response for example by inhibition of the cytokine     function. It has been shown that a high single dose of steroid infusion (30mg/kg solu-medrol)     inhibits the normal IL 6 response after colon resection. Newer studies have shown that even     at a lower dose the inflammatory response is inhibited. In several studies of head and neck     surgery the oedema in surgical area is reduced after a single dose of 125 mg solumedrol. It     is precisely this effect of reduced fluid formation we want to obtain in our study. We have     therefore chosen to use a single dose of 125 mg of solumedrol in this study. Even at the     largest single dose of glucocorticoids there have not been seen any increasing in surgical     complications.      The aim of the study: To find out whether single dose of glucocorticoid can reduce the seroma     formation after mastectomy      Study design : A randomised pilot study, with 2 x 20 patients. 125 mg solumedrol is given 1,5     hours before surgery in 20 patients, and the other 20 patients are the control group      Inclusion criteria: Women with primary breast cancer, undergoing a mastectomy with either     sentinel node biopsy or complete axillary dissection.   "
188154|NCT00307619|"     The purpose of this study is to evaluate the effectiveness and tolerability of topiramate     compared to placebo in patients with binge eating disorder receiving Cognitive Behavior     Therapy (CBT)   "
188155|NCT00307632|"     The purpose of this study is to evaluate the contraceptive efficacy, safety, cycle control,     compliance, and subject satisfaction of the transdermal contraceptive system, norelgestromine     and ethinyl estradiol (NLGM / EE).   "
188156|NCT00307645|"     The aim of IMPROVE is to define the optimal maintenance therapy for ANCA-associated     vasculitides (AASV) by comparing the AZA (standard regimen) with MMF in terms of efficacy,     i.e. in preventing relapses.      HYPOTHESIS :      MMF might be more effective than azathioprine as maintenance drug in AASV patients, reducing     by 50% relapse rate, with a same frequency of adverse effects   "
188158|NCT00308100|"     There are no standardized plasma volume replacement protocols during liver transplantation     surgery. The current study is designed to compare efficacy, safety, and costs of     perioperative volume replacement with Voluven (Hydroxyethyl starch 130/0.4) and albumin in     patients undergoing liver transplantation.   "
188159|NCT00308113|"     This study will help determine if CoQ10 and prednisone, alone and as a combination decrease     the decline in cardiopulmonary and skeletal muscle function that occurs in the wheelchair     confined phase of DMD. Participants who are enrolled in this study should not have taken any     corticosteroids within the last six months. This is a 13-month, prospective, randomized study     comparing a daily prednisone arm (0.75mg/kg/day), a CoQ10 arm (serum of greater than 2.5     ug/mL) and a combination arm (prednisone and CoQ10) with an enhanced standard of care arm in     wheelchair confined males age 10 to 18 years with an established DMD diagnosis.   "
188160|NCT00308126|"     Purpose: To compare the incidence of post-surgery complications and evaluate relevant     parameters within 28 days after an operation in HES (130/0.4) and albumin treated groups      Study Design: Open-label, active controlled, parallel group, randomized, multi-center study.     Per protocol, 624 patients required in 6 study centers.      Hypothesis: No difference in rate of postoperative (post-op) complications between HES and     albumin groups   "
188163|NCT00308165|"     This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it     is given directly into brain tumors by a delivery technique called convection-enhanced     delivery. This drug has been used for different types of cancer, but in this study it will be     given by an experimental delivery technique designed to maximize the amount of drug delivered     to the brain tumor and minimize the side effects in other parts of the body.      This study will also evaluate advanced magnetic resonance (MR) imaging techniques.      The study will assess quality of life parameters throughout the follow-up period.   "
188164|NCT00308178|"     The purpose of this trial is to see if Abraxane, which is a new form of paclitaxel, is safe     as a replacement form of paclitaxel in dose-dense chemotherapy. This trial will also     determine if using Abraxane will allow patients to receive treatment every two weeks without     requiring injects of G-CSF, a white blood cell stimulating growth factor.   "
188165|NCT00308191|"     The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment     of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide     alone.   "
188166|NCT00308204|"     The purpose of this study is to investigate the efficacy of Raptiva (efalizumab) in the     treatment of discoid lupus erythematosus (DLE). Discoid lupus erythematosus is a chronic     disorder, which may lead to permanent and progressive loss of hair. Lupus is a condition of     chronic inflammation cause by an autoimmune disease. Autoimmune diseases are illnesses which     occur when the body's tissues are attacked by its own immune system. The immune system is a     complex system within the body that is designed to fight infectious agents, for example,     bacteria, and other foreign invaders.      One of the mechanisms that the immune system uses to fight infections is the production of     antibodies. Patients with lupus produce abnormal antibodies in their blood that target     tissues within their own body rather than foreign infectious agents. Lupus can cause disease     of the skin, heart, lungs, kidneys, joints, and nervous system. When only the skin is     involved, the condition is called discoid lupus erythematosus (DLE).      Raptiva (efalizumab) is a humanized immunoglobulin(a protein extract from blood which fights     off infection-sometimes called antibody), which targets the immune cells that are activated     in inflammation. Raptiva has been approved for use in the management of psoriasis at doses of     1mg/kg, but is not approved for the treatment of DLE.   "
188167|NCT00308217|"     The objective of this research proposal is to perform an ongoing single institution     prospective clinical trial examining the overall clinical outcome of children with single     ventricle physiology.   "
188168|NCT00308230|"     The object of this study is to measure the levels of B-type Natriuretic Peptide (BNP) in     patients with congenital heart disease, normal individuals, and patients with acquired heart     failure, and compare the results from each group.   "
188169|NCT00308243|"     It is hypothesized that the inhalation of sodium pyruvate will reduce lung damage in patients     with Cystic Fibrosis (CF) by its ability to reduce levels of toxic reactive oxygen and     nitrogen compounds associated with the chronic inflammatory component of the disease. The     primary objective of the study is to assess the safety of inhaled sodium pyruvate in 0.9%     sodium chloride (saline) solution in people with CF. Further, to determine whether inhaled     sodium pyruvate will improve lung function, as determined by spirometry, or reduced     inflammatory markers in induced sputum of people with CF.   "
188183|NCT00308425|"     The primary aim of this study is to evaluate the safety and efficacy of EC-MPS plus valsartan     as part of an intensified multifactorial intervention on the reduction of the 12-month rate     of transplant nephropathy compared with EC-MPS plus standard practice of care in recipients     of a first cadaver donor kidney transplant given CsA-ME, basiliximab, and short-term     steroids.   "
188184|NCT00308438|"     The purpose of the study is to determine whether an investigational compound, ALX-0600, is     safe and effective in treating Crohn's Disease.   "
188343|NCT00310557|"     The purpose of this study is to look at the safety (what are the side effects) and efficacy     (how well does it work) of Magnevist (the study drug) used for MRI of the renal arteries. The     results will be compared to the results of MRI taken without Magnevist and with the results     of your X-ray angiography.   "
188170|NCT00308256|"     The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has     shown that in France, only 15% of children and 26% of adults had HbA1c<7%. Adolescents seem     to need particularly a better metabolic control.      Working Hypothesis:      We hypothesized that a stricter control of glycaemia by nurse-counselling could probably     improve metabolic control in adolescents with type 1 diabetes.      Objectives:      To show that nurse-counselling may improve levels of patient satisfaction.      Methodology:      The main criterion is the patient acceptance of diabetes measured by an analogical visual     scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to     10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to     improve patient's appreciation by 10 mm, near to I cope very well with my diabetes.      This is a randomised parallel group study with 36 subjects in each group. During the     follow-up, the routine follow-up group will continue its routine care. The complementary     follow-up group will be called by nurses every 15 days and consult monthly. HbA1c is the     secondary criterion and will be measured every 3 months.      The total study duration is 18 months including 6 months for the recruitment and 12 months     for the patients follow-up   "
188171|NCT00308269|"     This is a Phase I clinical trial evaluating the safety and tolerability of escalating doses     of vintafolide (EC145) in participants with relapsed or refractory advanced tumors. The     primary objective of this study is to determine the safety and maximum tolerated dose of     vintafolide given by intravenous bolus or infusion. The efficacy of the treatment will also     be measured.   "
188172|NCT00308282|"     This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of     treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for     patients with Rheumatoid Arthritis. Patients will receive three intravenous doses of     LY2127399 or placebo. Patients will participate in 10 or more visits to the study site, over     6 months. Evaluation of safety and efficacy will be conducted throughout the study.   "
188173|NCT00308295|"     The main goal of this study is to determine whether the American Heart     Association-recommended fish oil dose is efficacious, safe, and tolerable in hemodialysis     patients. The secondary objective is to test the effects of fish oil supplementation on     inflammatory and cardiovascular markers.   "
188178|NCT00308360|"     This is an eight-week open-label randomized parallel group clinical trial focusing on the     comparison of risperidone alone with risperidone plus valproate among hospitalized adult     patients diagnosed with schizophrenia who also exhibit problems with hostility. Patients may     have already been receiving risperidone or valproate (but not both) at study entry. Patients     not receiving valproate at study entry were randomized to receive either risperidone alone or     risperidone with valproate. For patients already receiving valproate at study entry, their     antipsychotic medication(s) was switched to risperidone, and they were followed for a     four-week lead-in period prior to baseline assessment and randomization to receive     risperidone alone or continue with risperidone and valproate. We hypothesized that     risperidone alone has an antiaggressive/antihostility effect, and that this effect is     augmented by the co-administration of valproate.   "
188179|NCT00308373|"     People with type 2 diabetes mellitus (earlier known as maturity onset diabetes mellitus) have     high blood levels of sugar and fat. This study is being done to determine if excessive sugar     entering the blood in people with type 2 diabetes mellitus is caused by excessive fat. We     will also evaluate how the anti-diabetic medications, pioglitazone and metformin taken by     mouth work to control blood sugar in people with diabetes.   "
188180|NCT00308386|"     Although strong clinical evidence exists that patients with diabetes should achieve certain     clinical goals (i.e. HbA1C, BP, LDL, etc.), to reduce morbidity and mortality national     surveys indicate that only a minority of people with diabetes achieves these goals.      Hypothesis: combination of nurse case management and enhanced behavior change counseling will     improve outcomes for glycemic control, blood pressure and cholesterol in high risk patients     with Type 2 diabetes when compared to usual care over a 3 year period.      Study design- The study will be a three year randomized control trial that will select     patients that have either A1C >8.5, LDL >130, or BP >140/90. Nurse case managers, trained in     clinical guidelines and brief behavior change counseling techniques (motivational     interviewing), will aim to foster patient adherence in the experimental group patients. Nurse     case managers will use standing orders to set an implementation of clinical guidelines (for     diabetes, hypertension, hyperlipidemia and depression) with individual follow up.      A total of 820 patients between the all 9 (6 Hershey Medical Center and 3 Reading Hospital     affiliated clinics) will be sought. One third of the study patients will be recruited from     the underserved Hispanic population in the Reading area. Patients will be randomized by     physician i.e. one physician will be randomly assigned to have all their patients co-managed     by a nurse case manager; the other will have usual care without any contact with nurse case     manager.      Nurses will be trained and then initiate a small pilot study in July thru August. Full     recruitment and initiation of study will begin in September 2006.      Clinic Activities - Each nurse will be responsible for 3 clinics. Nurses will work under the     supervision of the primary care physicians. A set of clinical guidelines will be developed     with physician input that will serve as the over-riding framework for the nurses.      Outcomes - Over a three-year period the investigators will evaluate clinical response     (improvements in A1C, BP, LDL, and depression when present) as well as a series of other     measures that will be obtained by surveys (patient satisfaction, quality of life,     self-management behaviors). Provider satisfaction will be measured using a standardized tool.     Finally, cost effectiveness of the intervention and evaluation of the potential barriers to     implementation will be studied.   "
188181|NCT00308399|"     A 7 day study which involves 2 nutrient drink tests, an ECG, a Scintigraphy scan, and a Sect     scan. This study requires the participant to make 4 visits to the GCRC in the Charlton     building but no overnight stays.   "
188182|NCT00308412|"     Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children     under 5 years of age, causing serious respiratory tract disease. The purpose of this study is     to test the safety of and immune response to a new HPIV vaccine in healthy infants and     children.   "
188373|NCT00297973|"     Compare the reduction in Framingham's predicted 10-year risk of a coronary event (6) in     patients with hypertension and at least three other cardiovascular risk factors (including     diabetic patients) seen in private practice and randomized to either Caduet or usual care.   "
188185|NCT00308451|"     The purpose of the proposed work is to assess the effects of a dietary supplement, containing     chromium (600 mcg per day) provided by chromium picolinate and biotin (2 mg per day) on     glycemic control in type 2 diabetes. Specifically, this study will assess whether use of the     supplement will lower the post-prandial rise in blood glucose experienced after ingestion of     a 75g carbohydrate load, relative to placebo, in type 2 diabetic patients. The study will     also assess the chronic effects of supplementation over a 4-week period (relative to placebo)     on fasting plasma levels of glucose, insulin, lipids and lipoproteins.   "
188186|NCT00308464|"     The purpose of this study is to explore the safety, toleration and dose response of     PHA-794428 after multiple weekly injections in male and female growth hormone deficient     patients.   "
188187|NCT00308477|"     This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone     for the treatment of macular edema associated with branch retinal vein occlusion.   "
188188|NCT00308490|"     The purpose of this study is to describe alterations of serum ferritin, transferrin     saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes,     reticulocyte hemoglobin content after iron loading in hemodialysis patients.   "
188189|NCT00308503|"     The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance     of patients with primary insomnia using night polysomnography recordings over a 6-week     treatment period corresponding to a stabilization of improvement of sleep.   "
188190|NCT00308516|"     This phase II trial will investigate the combination of adjuvant 5-fluorouracil, radiation,     and bevacizumab in patients with stage II and III rectal cancer, followed by FOLFOX6 and     bevacizumab. Fluorouracil (FU) has proven to be an effective and safe regimen in the     treatment of stage II and III rectal cancer. Recent evidence has proven     fluorouracil/leucovorin (FL) in combination with bevacizumab is superior to FL alone and when     combined with irinotecan is superior to (irinotecan plus fluorouracil/leucovorin (IFL) alone.     This trial will be one of the first clinical trials to evaluate a combination of targeted     therapy, radiation, and chemotherapy in the adjuvant treatment of a common solid tumor.   "
188191|NCT00308529|"     This proposed phase II trial will investigate the combination of irinotecan, carboplatin and     bevacizumab along with radiation in the treatment of patients with limited-stage SCLC. This     study differs from our maintenance bevacizumab trial in that bevacizumab will begin with     the initial chemotherapy treatment. Irinotecan/platinum regimens are emerging as standard     treatments for patients with extensive-stage disease. Adding a novel minimally toxic agent to     this regimen up front may further enhance this doublet's efficacy without contributing to     toxicity. This trial will be one of the first clinical trials to evaluate a combination of     targeted therapy and chemotherapy in the up front treatment of a common solid tumor.   "
188192|NCT00308542|"     This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for     the treatment of diabetic edema.   "
188193|NCT00308555|"     We are conducting a study to assess whether smoking marijuana affects the safety of     prescribed opioids in patients treated for chronic pain. This study will assess whether     smoking cannabis affects the absorption, distribution, metabolism and excretion of widely     used opioid analgesics. We propose to do this by investigating the effects of smoked cannabis     in subjects prescribed morphine or oxycodone for chronic pain. We will also assess the     clinical safety of cannabinoids and these opioids by monitoring the short-term side effects     associated with combined therapy.   "
188194|NCT00308568|"     The purpose of this study is to evaluate the effect of a mailed educational brochure on     adherence to referral for screening colonoscopy. The comparison (or control) group receives     no mailer, which is usual care.   "
188195|NCT00308581|"     To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over     26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with     infliximab   "
188196|NCT00308594|"     The purpose of this study is to determine whether dexamethasone is effective in the treatment     of pain and disability resulting from a compressed spinal nerve in the neck (cervical     radiculopathy).   "
188197|NCT00308607|"     The purpose of this study is to determine whether combination therapy with bevacizumab     (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) is effective in patients with     locally advancing or metastatic melanoma.   "
188198|NCT00308620|"     Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV     effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for     malaria treatment and prevention, and it also has significant anti-inflammatory effects. No     formal study of chloroquine has been performed in people with HIV infection. Chloroquine is     used worldwide and is quite inexpensive outside of the United States. If shown to be     effective, chloroquine could be a very important tool worldwide in delaying HIV disease     progression which would extend the time period without needing anti-retroviral therapy. In     countries where anti-retroviral therapy is not available, this could be very helpful.      This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a     once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws     for CD4 counts, HIV viral loads, and other research tests. The visits are at study     enrollment, 4 weeks, and 8 weeks.   "
188215|NCT00308841|"     Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing     patient discomfort during the removal of a lost intrauterine device (IUD).      Methods: This double-blinded, randomized, placebo-controlled trial included 68 women who     underwent removal procedure for a lost IUD. Thirty-four women were allocated to the     lidocaine group and 34 to the saline group. The main outcome measure was the intensity of     pain during, immediately after, and 20 minutes after the procedure, assessed by a visual     analog scale. Statistical analysis was performed using Friedman's test with Bonferroni     correction, Student's t test, and 2.   "
188216|NCT00308854|"     The aim of this study is to investigate whether PD P 506 A-PDT is effective in treating mild     to moderate AK lesions located on the head.   "
188217|NCT00308867|"     The aim of this study is to investigate how the efficacy and tolerability of PD P 506 A-PDT     relate to the commonly used cryosurgery in the treatment of mild to moderate AK lesions     located on the head. To be able to quantify the effect the patient will be allocated to one     of three treatments: PD P 506 A-PDT, cryosurgery or placebo-PDT.   "
188199|NCT00308633|"     This study will measure blood levels of endothelial progenitor cells (EPCs) and nitric oxide     (NO) in patients with coronary artery disease (CAD) who are participating in a 3-month     cardiac rehabilitation program at Suburban Hospital in Bethesda, MD. EPCs are a kind of stem     cell produced by the bone marrow that can develop into cells found in arteries and in the     heart and, therefore, can repair diseased vessels. The study will examine whether the EPCs     are affected by exercise and will look at how they may contribute to repair of cells lining     the diseased arteries as a result of participation in the rehabilitation program.      People with coronary artery disease may be eligible for this study. Candidates are screened     with a medical history, physical examination, electrocardiogram, and blood tests. CAD     patients also to a treadmill exercise test.      Volunteers' participation ends at the screening visit. The blood drawn at screening is used     to identify EPC specific genes to compare with the EPC genes from patients with CAD.      CAD patients participate in Suburban Hospital's cardiac rehabilitation program. The exercise     portion of the program includes 36 sessions of about 60 minutes each, spaced over     approximately 3 months. Patients have a baseline blood test at screening and repeat blood     tests at the end of each month of participation in the rehabilitation program. Some of the     blood will be used for genetic tests to see how genes of the EPCs are changed by the     patient's participation in the rehabilitation program.   "
188200|NCT00308646|"     It will be more effective if we can work on the primary prevention for the high risk groups     of diabetes and prediabetes such as the early detection.   "
188201|NCT00308659|"     Main hypothesis: microbiological diagnossis off severe community acquired pneumonia can be     performed by non invasive or semi invasive microbiological tools, semi invasive tools     including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB).     A microbiological diagnosis could improve antibiotic therapy efficacy and improve patient's     outcome.      These Two strategies have never been prospectivally evauated.        -  Aim of the study: To evaluate 2 diagnostic strategies: non invasive or semi invasive          including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy          (FOB)for the care of patients admitted in intensive care for severe community acquired          pneumonia and receiving an empirical antibiotic therapy as recommanded by 2001 American          thoracic guidelines        -  Type of study randomized multicentric controlled open study   "
188202|NCT00308672|"     The secondary objective is to evaluate the agreement between these criteria and the     prevalence of concordant and discordant according to different criteria.   "
188203|NCT00308685|"     This study is designed to evaluate the repeat-dose safety and effectiveness of a     bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11     years with asthma. The dosing period lasts three weeks and starts following a three-week     run-in period.   "
188204|NCT00308698|"     High recombinant human erythropoietin requirement and elevated serum adiponectin were     significant determinants of long-term mortality in patients who started hemodialysis therapy.   "
188205|NCT00308711|"     The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and     100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R)     in women who need to have cervical ripneing and induction of labor.   "
188206|NCT00308724|"     The purpose of this study is to determine whether cognitive behavior therapy (CBT) is     effective in the treatment of generalized anxiety disorder (GAD) in adults age 60 and older     in a primary care setting.   "
188207|NCT00308737|"     Pulmonary Safety in Diabetics with T/I   "
188208|NCT00308750|"     The purposes of this study are to determine:      The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or     docetaxel with carboplatin and any side effects that might be associated with the combination     of these drugs.      Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and     carboplatin can help patients with non-small cell lung cancer live longer, compared with the     combination of docetaxel and carboplatin.      Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and     carboplatin can make your tumor smaller or disappear, and for how long, compared with the     combination of docetaxel and carboplatin.      The effects of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin or     docetaxel with carboplatin have on your disease related symptoms.      The relation of smoking history and hormone replacement therapy (for women only) may have to     your lung cancer treatment results.      The effects of certain genes and proteins in samples of your blood and tumor tissue in order     to learn more about non-small cell lung cancer and how enzastaurin works in the body.   "
188209|NCT00308763|"     Nicotine addiction is a serious health problem in the United States; 46 million people smoke     cigarettes, and 70% of those are trying to quit. The nicotine patch and bupropion, a     medication used to reduce nicotine cravings, are two commonly used smoking cessation aids.     Both have been shown to reduce smoking rates, however, the effectiveness of combining the two     treatments has not been widely examined. This study will evaluate the effectiveness of the     nicotine patch combined with bupropion at reducing smoking rates among younger, low-income,     and minority individuals.   "
188210|NCT00308776|"     This study will determine the effectiveness of administrating a dose of cholecystokinin     during a binge eating episode in reducing this eating behavior in people with bulimia     nervosa.   "
188211|NCT00308789|"     The purpose of this study is to compare two methods of delivering Nasal Continuous Airway     Pressure (NCPAP): Biphasic Mode and a continuous mode, to see which is better in getting     babies off the ventilator and decreasing lung damage.   "
188212|NCT00308802|"     The purpose of this study is to test noninvasive methods to monitor the health and condition     of new kidneys in people who have received kidney transplants.   "
188213|NCT00308815|"     This is a randomized controlled prospective study which assigned patient to receive manual     CPR or automatic CPR machine use. The quality and efficacy between manual CPR and machine CPR     will be evaluated.   "
188214|NCT00308828|"     The purpose of this study is to determine the prevalence and severity of osteoporosis in     hemodialysis patients and to evaluate potential correlations with renal bone disease indices   "
188374|NCT00297986|"     In this study the investigators aimed to study the ventilatory performance of different     interfaces during NPPV delivering.   "
188218|NCT00308880|"     Tranexamic acid belongs to fibrinolytic inhibitors. Several prospective randomized clinical     trials have proved its effectiveness in reducing intra-operative and post-operative bleeding     in orthopedic and cardiovascular surgeries. However, there is little study about tranexamic     acid in reducing post-operative bleeding in head and neck surgery. So the aim of this study     is to investigate if tranexamic acid could reduce post-operative bleeding via prospective     double-blinded randomized clinic trial.   "
188219|NCT00308893|"     The main hypothesis is that the therapeutic response and pharmacological resistance to ADs in     depressed patients can be associated with a polymorphism for the BDNF gene. The research of     allelic forms associated to lesser efficiency or inefficiency of ADs could add to the body of     evidence that BDNF mediates the mechanism of action of ADs, and could have important     practical implications. We propose to compare in a group of patients with major depression,     the allelic variability of the BDNF gene between responders and non-responders after a 3-week     period and a 6-week period of SSRI treatment.   "
188220|NCT00308906|"     The purposes of this study are to identify potential gene and protein markers of     aminoglycoside-induced kidney injury in infants, children and adolescents treated with     aminoglycoside antibiotics.   "
188221|NCT00308919|"     To assess by MR Imaging the lesions induced by WST09-mediated photodynamic therapy (PDT) in     patients with recurrent or persistent localized prostate cancer following definitive     radiotherapy using different light doses and multiple illuminating fibres.   "
188222|NCT00308932|"     To determine the effect of age and device on delivery of HFA-Fluticasone Propionate (FP) in     children of different ages. Hypothesis -- passive inhalation in younger children through a     valved holding chamber/mask (VHC) will reduce the relative amount of FP delivered to airways.   "
188223|NCT00308945|"     Vasoactivity of topical drugs may be of prognostic relevance in glaucoma. There is very     little information for a major class, the prostaglandin analogues with regard to this aspect.     The purpose of this study is to compare the effect of travoprost 0.004% and latanoprost     0.005% on choroidal blood flow and retinal vascular diameter in glaucoma patients. After     washout of current topical medication, intraocular pressure (IOP) in both eyes (Goldmann     applanation tonometry), choroidal blood flow (laser Doppler flowmetry) and retinal vessel     diameter (Retinal Vessel Analyzer) in one randomly selected eye will be measured at baseline,     after two weeks and after 4 weeks of treatment with travoprost or latanoprost QD, in a     randomized, double masked 2-way cross-over study in 20 open angle glaucoma patients.   "
188273|NCT00309608|"     The objective of the study is to test the efficacy, safety and tolerability of several doses     of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks     together with metformin in patients with type 2 diabetes mellitus who are not at goal with     their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as     add-on therapy to metformin for comparison. The influence of several factors (gender, age,     weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in     this study.   "
188224|NCT00308958|"     Patients with cystic fibrosis (CF) must perform daily bronchial drainage therapy (BD) to keep     their airways clear of secretions. Many different techniques are available to achieve this     and there is currently no agreement as to which form of therapy is most effective. High     frequency chest wall oscillation (HFCWO is used for this purpose by CF patients throughout     the United States and abroad. To perform this therapy, the patient wears a vest which fits     over the entire torso and is connected to an air compressor. The compressor generates     oscillating air pulses that are transmitted to the lungs, thereby mobilizing secretions. The     oscillations produced by the most commonly used device have a sinusoidal wave form (The Vest™     Airway Clearance System, Hill-Rom Inc, St Paul, MN). Previous studies indicate this form of     therapy is as effective as more traditional and cumbersome forms of therapy. The design of     the pulse generator has been recently modified so that the oscillations produced have a     triangular wave form (Respitech Inc, MN). Studies done at the University of Minnesota found     that the air flows induced in the airways can vary substantially depending on the wave form     applied to the chest. At present, the impact of using a triangular wave form on mucus removal     is unknown. The proposed study will compare mucous clearance using a device generating sine     wave oscillations to a device generating triangular wave oscillations.      Hypothesis: Bronchial drainage using a triangular wave form of HFCWO will result in superior     sputum production compared to HFCWO using a sine wave form.      Secondary Hypotheses:      Bronchial drainage using a triangular wave form of HFCWO may result in sputum with rheologic     properties distinct from sputum produced while using sine wave HFCWO.      Bronchial drainage using a triangular wave form of HFCWO may result in superior post-therapy     pulmonary function tests compared to pulmonary function tests obtained following therapy with     sine wave HFCWO.      Subjects will perceive bronchial drainage using a triangular wave form of HFCWO as more     comfortable than airway clearance using sine wave HFCWO.   "
188225|NCT00308971|"     Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in     both the chronic kidney disease (CKD; pre-dialysis) and end stage renal disease (ESRD; on     hemodialysis) populations, and several lines of evidence point to their contribution in the     development of atherosclerosis. Biomarkers of the inflammatory state such as C-reactive     protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and death in     these two populations. The uremic state is characterized by retention of oxidized solutes     including reactive aldehyde groups and oxidized thiol groups. It has recently been     demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of     oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the     atherosclerotic uremic metabolic state. In this study we hypothesize that administration of     antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress     in patients with Stage III and IV CKD.   "
188226|NCT00308984|"     The purpose of this study is to describe the incidence of recall or awareness under     anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data     relating to intra-operative recall during general anesthesia.      The hypothesis is that the implementation of routine awareness follow-up evaluation in     children undergoing general anesthesia will identify that the incidence of intra-operative     awareness in children is equal to or greater than in adults.   "
188227|NCT00308997|"     This study will determine the efficacy of MRI-guided transcranial magnetic stimulation     (TMS)in reducing voices and other symptoms experienced by people with schizophrenia and     schizoaffective disorder. In addition, the study will determine duration of improvement     obtained during the course of trial participation via on-going monthly contact with study     participants for up to 1 year after the trial.   "
188253|NCT00309348|"     This research study aims to show that a newly developed investigational Doppler instrument     can reliably measure blood flow in dialysis access grafts, to see if a decrease in the flow     may be a sign of impending graft failure and also to see if there is evidence that by     monitoring the flow in these grafts their lives may be extended.      The new investigational device is to be known as FloMon; this is an ultrasonic device that     provides blood flow measurements from a small probe placed in a noninvasive manner above the     graft or blood vessel. The instrument is being developed so that it may help give insight to     on-coming graft failure which may be prevented.      The FloMon is an extension of a previously Food and Drug Administration (FDA) cleared     instrument, Echoflow-A, which had been used in a similar study as this one. The Echoflow-A is     similar to this device in all respects with the exception of design and calculation of     measurement. The FloMon compared to the Echoflow-A is better ergonomically designed and reads     flow readings in about 2 minutes versus twice the time necessary to take similar measurements     using the Echoflow-A.   "
188228|NCT00309010|"     This study will examine how the brain coordinates movement in patients with focal hand     dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and     repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such     as the hand, neck or face, is involved. This study will use transcranial magnetic stimulation     (TMS, see below) to study how the brain plans movement.      Healthy volunteers and patients with focal hand dystonia 18 years of age and older may be     eligible for this study. Healthy subjects may participate in one, two or three of the     experiments described below. Patients with dystonia may participate in experiments one and     three.      Before each experiment, each subject is asked about his/her medical and neurologic history,     complete questionnaires and will undergo a brief physical examination.      Experiment 1        -  Surface EMG: Small electrodes are taped to the skin over the arm to measure the          electrical activity of muscles.        -  TMS: A wire coil is held on the subject's scalp. A brief electrical current is passed          through the coil, creating a magnetic pulse that stimulates the brain. During the          stimulation, the subject may be asked to tense certain muscles slightly or perform other          simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg,          and the subject may hear a click and feel a pulling sensation on the skin under the          coil.      Experiment 2 (Two visits.)        -  Visit 1: Magnetic resonance imaging (MRI): This test uses a magnetic field and radio          waves to obtain images of body tissues and organs. The patient lies on a table that is          moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and          thumping sounds that occur during the scanning process. The procedure lasts about 90          minutes, during which time the patient will be asked to lie still for up to 30 minutes          at a time.        -  Visit 2: Surface EMG and TMS      Experiment 3      -Surface EMG and TMS - During the TMS, subjects are asked to respond to shapes on a computer     screen by pushing a button or pressing a foot petal.   "
188229|NCT00309023|"     This is a Phase I/II, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137     monoclonal antibody, administered every three weeks to patients with metastatic or locally     advanced solid tumors.   "
188230|NCT00309036|"     The trial is performed to assess efficacy and safety of a recombinant grass Pollen allergen     cocktail in allergic rhinoconjunctivitis   "
188231|NCT00309049|"     The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.   "
188232|NCT00309062|"     Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic     rhinoconjunctivitis   "
188233|NCT00309075|"     The purpose of this study is to look at the safety (what are the side effects) and efficacy     (how well does it work) of Magnevist (the study drug) used for MRI of the calf and foot     arteries. The results will be compared to the results of MRI taken without Magnevist, and     with the results of your X-ray angiography.   "
188234|NCT00309088|"     The purpose of the study is to investigate the efficacy and safety for steroid non-resistant     MG patients in a double blind, placebo controlled study.   "
188235|NCT00309101|"     The purpose of the study is to investigate the efficacy and safety for steroid resistant,     non-thymectomized MG patients.   "
188236|NCT00309114|"     Urinary tract infection (UTI) is the most common infection in patients with spinal cord     injury (SCI) and is linked to major undesired results or complications including death. The     bladder of SCI patients, especially those with indwelling catheters, is usually colonized by     bacteria, some of which do and others which do not cause symptoms of UTI. Bacteria that do     not cause symptoms are often called benign colonizers and are often left untreated because     they may provide some protection against infection with more harmful bacteria. This idea of     using benign bacteria to prevent infections with symptoms is called bacterial interference. A     prototype strain, Escherichia coli 83972, was shown to begin and continue for extended     periods of time non symptom causing colonization of the human bladder and to hold back     symptom causing infections of the neurogenic bladder. Data from pilot studies at two medical     centers indicated that bacterial interference might be a useful therapy for reducing the rate     or frequency of UTI in SCI patients. Because almost all SCI patients have a UTI at some time,     and also the large costs of treating this infection, studying the impact of bladder     colonization with E. coli 83972 on the rate of symptom causing UTI has an amazing potential     for improving the quality of life of SCI patients and decreasing the cost of health care.     Like with other preventive plans such as vaccination, for instance, it is important to     explore the effectiveness of this new preventive approach. The project is a prospective,     randomized, double blind, multi-center study that deals with specific pieces of bacterial     interference in SCI patients.      HYPOTHESES: Placing non symptom causing bacteria (E. coli 83972) into SCI patients' bladders     reduces the rate of symptom causing UTI.      A. SPECIFIC AIM: Determine how bladder colonization with E. coli 83972 or similar bacteria     affects the rate of symptom causing urinary tract infections in a large group of SCI and     Spina Bifida patients by conducting a prospective, randomized, placebo-controlled,     multi-center clinical trial.   "
188237|NCT00309127|"     Disease management using a multidisciplinary team to achieve and maintain optimal metabolic     and cardiovascular risk factors control in Type 2 diabetic patients with nephropathy reduces     the incidence of end stage renal disease (ESRD) and improves clinical outcomes compared to     usual clinic-based care   "
188238|NCT00309140|"     This study will collect further basic safety data on patients with cancer treated with     enzastaurin. This study is not open to the public.      The purpose of the this study is to extend the clinical experience of patients who complete     enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli     Lilly and Company and who may benefit from continued enzastaurin therapy.   "
188239|NCT00309166|"     The main aim of this vaccine is to prevent cervical cancer in women. However, it could also     be relevant to vaccinate selected groups of males. Therefore, this study is designed to     evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male     subjects aged 10-18 years.   "
188240|NCT00309179|"     This study proposes to determine the safety of the administration of E7820 plus cetuximab and     explore the MTD of the combination in a Phase Ib study. In addition, the efficacy of this     combination will be explored in patients with colorectal cancer in the Phase II proof of     concept phase of the study.   "
188241|NCT00309192|"     The purpose of this study is to determine whether intravitreal injection of Triamcinolone     Acetonide is effective in the treatment of Clinically Significant Diffuse Macular Edema due     to Type 2 Diabetes Mellitus.   "
188242|NCT00309205|"     Approximately 36 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each     volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers     will receive investigational product for a total of 42 days.   "
188243|NCT00309218|"     The present study investigates the safety and efficacy of steroid withdrawal in pediatric     renal transplant recipients with stable graft function under concomitant immunosuppression     with cyclosporine and mycophenolate mofetil.   "
188244|NCT00309231|"     The purpose of this study is to perform a series of islet transplants using the Edmonton     protocol. Patients with Type I Diabetes and glycemic lability, severe hypoglycemia or     hypoglycemic unawareness will undergo transplantation of purified pancreatic islets from     cadaveric donors into the portal vein, followed by steroid-free immunosuppression as per the     Edmonton protocol (IL-2 antibody induction, sirolimus, low dose tacrolimus-based     immunosuppression). The goals of the transplant are to improve glycemic control, stabilize     blood sugars and achieve insulin independence.   "
188245|NCT00309244|"     The purpose of this 13 month study (12 month treatment period and 1 month follow-up period)     is to determine whether inhaled insulin is safe and effective in the treatment of type 2     diabetes.   "
188246|NCT00309257|"     Alport syndrome (AS) represents a form of progressive hereditary nephritis in which the     genetic defect resides in the synthesis of one of several subunits of type IV collagen, the     predominant constituent of basement membranes in renal glomeruli. Renal impairment occurs     with time and severe renal failure with hypertension and uremia represent the end stage of     the disease, even if a high variability in the rate of progression is described.Males are     usually affected by a progressive form of the disease. Affected females with X-linked     syndrome usually have a good prognosis with a mild renal impairment. The disease is also     associated to a sensor neural deafness which can occur in approximately half of the patient     affected and usually correlates with renal impairment. No definite treatment exists in order     to delay the time of dialysis or a kidney transplant. Many studies showed that Angiotensin     converting enzyme (ACE) inhibitors slow glomerular filtration rate (GFR) decline and limit     progression to end stage renal disease (ERDS) and dialysis in several chronic nephropathies     associated with proteinuria. The combination of ACE-I with Angiotensin II receptor     antagonists may reduce proteinuria more effectively than the two drugs alone. Moreover the     addition of statins may synergize the antiproteinuric effects of ACE-I and ATAII antagonists     in experimental models of chronic renal diseases.      The purpose of this study is to evaluate the effect of a standardized multimodal     nephroprotection intervention (Remission Clinic) in Alport patients with renal involvement.   "
188247|NCT00309270|"     During the past 15 years, however, the superior immunosuppressive efficacy of CsA and the     well-known toxicity of long-term steroid therapy have prompted trials of steroid withdrawal     from renal allograft recipients at various intervals after transplantation. Steroid     withdrawal or avoidance must be balanced against the associated risk of precipitating acute     allograft rejection. Moreover, with the current immunosuppressive regimens, by 10 years     approximately 50% of grafts will have been lost due mainly to chronic rejection or the     side-effects of immunosuppressive therapy. Thus, the quest for therapies that might induce     specific immune tolerance – ideally via short-term interventions that would target only the     pathogenic immune response and leave the protective host immune response unimpaired – has     provided a “holy grail” for transplant immunologists.      The humanized IgG monoclonal antibody Campath-1H has been hypothesized to provide enough     immunosuppression that would allow maintenance therapy with low-dose CsA, and possibly     reprogramming the immune system so to encourage tolerance processes. Despite Campath-1H     immunosuppressive regimens have been claimed to induce a condition of “almost tolerance”,     this has not been proved nor evidence of development of persistent regulatory immune     responses long-term post transplant has been provided. Thus, characterizing phenotypically     and functionally distinct subsets of T-regulatory cells possibly generated selectively in     non-rejecting transplant recipients in Campath-1H-based immunosuppressive regimens may help     to find new noninvasive markers of immune system activation to tailor immunosuppressive     protocols.      The primary aim of the study is to compare the effect of Campath-1H, low dose sirolimus     versus Campath-1H, low dose CsA, both in addition to low dose MMF on phenotypic and     functional profiles of peripheral blood mononuclear cells (PBMCs) in kidney transplant     recipients in a steroid-free regimen.   "
188248|NCT00309283|"     Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal     disease, responsible for 8% to 10% of the cases of end stage renal disease (ESRD) in Western     countries. At comparable levels of blood pressure control and proteinuria, patients with     ADPKD have faster decline in glomerular filtration rate than those with other renal diseases     and do not seem to benefit to the same extent of ACE inhibitor therapy. A reasonable     explanation for the above findings is that in ADPKD progression is largely dependent on the     development and growth of cysts and secondary disruption of normal tissue. Thus,     renoprotective interventions in ADPKD - in addition to achieve maximal reduction of arterial     blood pressure and proteinuria and to limit the effects of additional potential promoters of     disease progression such as dyslipidemia, chronic hyperglycemia or smoking - should also be     specifically aimed to correct the dysregulation of epithelial cell growth, secretion, and     matrix interactions characteristic of the disease.      Evidence that specific receptors for somatostatin are present in the kidney tissue, arises     the possibility that somatostatin treatment in patients with ADPKD might inhibit fluid     formation and eventually induce the shrinking of renal cysts.To evaluate the tolerability and     the safety of long-acting somatostatin in ADPKD patients, a prospective cross-over controlled     study has been recently performed. This pilot study demonstrated the safety of six month     treatment of long-acting somatostatin in patients with ADPKD. Moreover, the percent increase     of total kidney volume was significantly lower in patients on somatostatin than in placebo.     Overall, these findings provide the basis for designing a long-term study in ADPKD patients     aimed to document the efficacy of the somatostatin treatment in preventing further increase     or even reducing the total kidney volume and the renal volume taken up by small cysts,     eventually halting kidney disease progression.   "
188249|NCT00309296|"     The purpose of this study is to determine whether an extended care treatment model lasting     over a year will increase long-term smoking cessation rates compared to the standard 8 week     treatment of care.   "
188250|NCT00309309|"     Abnormalities in glucidic and lipidic metabolism are common features in renal transplant     patients on chronic immunossupression with steroids and calcineurin inhibitors. In kidney     transplant patients with chronic rejection these abnormalities cluster with renal and     cardiovascular risk factors and altogether may sustain premature graft loss and may increase     the risk of cardiovascular morbidity and mortality. Thiozolidinediones are a new class of     oral antidiabetic agents that may increase insulin sensitivity improving the glucose     tolerance and dyslipidemia. Moreover, rosiglitazone –one of these drugs- has been reported to     decrease blood pressure and albuminuria in subjects with type 2 diabetes and nephropathy.     Recent finding that glitazones ameliorate the glucidic and lipidic profile induced by steroid     treatment in healthy subjects, provided a further rationale to evaluate the metabolic and     renal effects of glitazones in renal transplant patients on chronic steroid therapy. Thus, we     designed and organized a pilot study to assess the short-term risk/benefit profile of     rosiglitazone in renal transplant patients with chronic rejection. Ten patients will have a     basal evaluation of insulin sensitivity, glucose tolerance,lipid profile, renal hemodynamic     and albuminuria. These evaluations will be repeated at the end of the treatment (4 months of     therapy with rosiglitazone 8 mg/day) period and 2 months after treatment withdrawal.   "
188251|NCT00309322|"     This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled     study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11     years of age. NV-101 or sham injection is administered at the completion of a dental     procedure requiring local anesthesia with 2% lidocaine with 1:100,000 epinephrine. The dental     procedure(s) shall be performed in a single quadrant of the mouth and include cavity     preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing),     or crowns.   "
188252|NCT00309335|"     This Phase 3 clinical study is designed as a multicenter, randomized, blinded, controlled     study to evaluate the efficacy, pharmacodynamics, and safety of NV-101 administered as a     submucosal injection following completion of a restorative or periodontal maintenance     procedure requiring local anesthesia with an agent containing a vasoconstrictor. Local     vasodilatation that results in more rapid clearance of the anesthetic is the proposed     mechanism of action.   "
188298|NCT00309946|"     This phase II trial is studying how well cediranib maleate works in treating patients with     malignant mesothelioma that cannot be removed by surgery. Cediranib maleate may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking     blood flow to the tumor   "
188254|NCT00309361|"     This Phase 3 study is designed as a multicenter, randomized, blinded, controlled study to     evaluate the efficacy, pharmacodynamics, and safety of NV-101 administered as a submucosal     injection following completion of a restorative or periodontal maintenance procedure     requiring local anesthesia with an agent containing a vasoconstrictor. Local vasodilation     that results in more rapid clearance of the anesthetic is the proposed mechanism of action.   "
188255|NCT00309374|"     The purpose of this study is to determine the effects of HMG-CoA reductase inhibitor     pretreatment on inflammation and coagulation activation in human endotoxemia.   "
188256|NCT00309387|"     The Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related     Cataract (CTNS) is a 13-year study designed primarily to evaluate the safety and efficacy of     a vitamin-mineral supplement (Centrum) containing recommended daily-allowance dosage (RDA) in     preventing age-related cataract or delaying its progression in participants with early or no     cataract at baseline.   "
188257|NCT00309400|"     We are doing this study to learn more about the early history of universal screening for     metabolic disorders such as PKU and galactosemia. In particular, we are interested in     learning from our past experience to inform our current plans to expand universal newborn     screening. Following standard historical research methodology, we will begin with a review of     the historical scholarship on PKU and galactosemia, including more general works on mental     retardation, genetics, public health screening, and metabolic disorders. We will also obtain     scientific publications and archival sources on the early screening and treatment of these     disorders. Lastly, we will conduct oral history interviews with key participants in teh early     screening and treatment of PKU and galactosemia.   "
188258|NCT00309413|"     The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is     effective in the treatment of acute schizophrenic or schizophreniform psychosis in a     placebo-controlled, randomized double-blind study.   "
188259|NCT00309426|"     The purpose of this study is to examined the effect of fetuin A on atherosclerosis and     prognosis in hemodialysis patients.   "
188274|NCT00309621|"     Patients with severe chronic hand dermatitis, that has not responded to topical treatment,     including topical steroids and the avoidance of aggravating factors, will be treated with the     oral medication alitretinoin. The study aims to investigate the safety and efficacy of the     medication when given over a period of 6 months.   "
188260|NCT00309439|"     The problem is the lack of data from randomized controlled trials to throw light on the     ALA-prostate cancer issue. There is therefore a need to acquire evidence from a randomized     controlled study to illustrate the effect of ALA on a surrogate marker for prostate cancer,     namely prostate specific antigen (PSA). Demonstration that atrial fibrillation recurrence was     reduced after cardioversion and that there was no adverse effect of 1 years of ALA feeding on     PSA would go a considerable way to providing the required evidence that ALA in the human diet     has no adverse effect on the prostate and so allow its use for cardiovascular risk reduction.     hypothesis: The effect of ALA on PSA levels over time will be no different from the control,     so providing supportive data for the view that ALA is not cancer promoting.   "
188261|NCT00309452|"     The purpose of this study is to understand the effectiveness of a specialized package of     phase-specific treatments for individuals in the midst of their first episode of psychosis.     The pharmacologic and psychosocial treatments will be delivered within a state public mental     health center.   "
188262|NCT00309465|"     The main objective of this study is to compare three strategies of evening insulin glargine     dosing to preoperative glucose values in patients with diabetes undergoing surgery to     determine which dosing strategies most often achieves the admission target study values of     100-179 mg/dl.   "
188263|NCT00309478|"     Primarily, this clinical investigation compared the efficacy of cyclophosphamide +     methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of     prognosis (disease-free survival, overall survival) in premenopausal patients with     potentially curative, operated hormone receptor-positive breast cancer.   "
188264|NCT00309491|"     Primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide     vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with     potentially curative, operated hormone receptor-positive breast cancer.   "
188265|NCT00309504|"     The purpose of this study is to find ways to improve the appearance of tumours or markers     that indicate the presence of tumours in Magnetic Resonance Imaging (MRI). Although based on     the same technology, there are many ways to obtain images using MRI. The type of image that     will be produced by the scanner depends on the instructions sent to the machine. These     instructions tell different components of the machine when to turn on and off and all     together are called a pulse sequence. These pulse sequences can get quite lengthy and     intricate and small changes in them can produce considerable changes in the resulting image.     the aim of this protocol is to alter existing pulse sequences to improve image appearance.     This protocol will involve only healthy volunteers.   "
188266|NCT00309517|"     This clinical investigation examined the influence of preoperative radiotherapy in     combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil +     leucovorin + MAb 17-1A chemo-immunotherapy on patients’ local recurrence rate and overall     survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).   "
188267|NCT00309530|"     This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or     interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple     combination, in terms of recurrence-free and overall survival in curatively operable colon     carcinoma Stage III.   "
188268|NCT00309543|"     This clinical investigation examined the influence of cytostatic chemotherapy with     5-fluorouracil, modulated by biologically active leucovorin, on patients’ survival time     following surgery for colon carcinoma Stage II.   "
188269|NCT00309556|"     Primarily, this clinical investigation compares the rates (percentages) of pathological     complete remissions attained at the time of final surgery following 6 cycles each of     epirubicin + docetaxel + capecitabine-containing chemotherapy ± trastuzumab (in HER-2     positive disease) vs. epirubicin + docetaxel-containing chemotherapy ± trastuzumab (in HER-2     negative disease).   "
188270|NCT00309569|"     Primarily, this clinical investigation compared overall survival and recurrence-free survival     in patients with hormone receptor-negative breast cancer treated with pre- and postoperative     chemotherapy vs. conventional postoperative treatment.   "
188299|NCT00309959|"     This phase II trial is studying how well ABI-007 works in treating patients with persistent     or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.   "
188271|NCT00309582|"     Nevirapine (NVP)-based antiretroviral therapy (ART) has been commonly used in many developing     countries due to its affordability and feasibility. Nonetheless, the potential drug-drug     interaction between NVP and fluconazole (FLU) is a major concern. NVP can induce cytochrome     P450 isoenzymes in the liver while FLU inhibit the activity of this enzyme. The recent report     has demonstrated that fluconazole significantly raises plasma NVP levels and may cause     serious hepatotoxicity. Conversely, NVP does not significantly influence the plasma level of     FLU. However, there have not been enough data or any recommendations to adjust NVP dosage for     the concurrent use of both drugs in order to avoid the adverse events. A previous study has     demonstrated that genetic disposition may play a role in NVP hypersensitivity reactions.     There is little data of safety and tolerability for concurrent use of NVP and FLU in Asian     populations. We therefore conducted this prospective observational study to compare the     trough plasma NVP levels and frequencies of adverse events among antiretroviral HIV-infected     patients who did not receive FLU and received FLU in different dosages for cryptococcosis     prophylaxis or treatment; and subsequently received NVP-based ART regimens.   "
188272|NCT00309595|"     This is a multi-center prospective, randomized, two-arm study evaluating performance of the     Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be     randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered     into the study.      Objective of the study is: Performance of the Cordis S.M.A.R.T.™ (CONTROL™) Nitinol Stent     System for the treatment of superficial femoral artery (SFA) long de novo or restenotic     lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined     by Binary Restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one     year as demonstrated by Duplex sonography.   "
188380|NCT00303472|"     The purpose of this study is to evaluate the safety and tolerability of romiplostim in     thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will     evaluate the platelet response to romiplostim.   "
188275|NCT00309634|"     Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian     virus. Prevention and control of a pandemic will depend on the rapid production and worldwide     distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be     developed and tested in clinical trials to determine the most optimal formulation and the     best vaccination schedule.This study is designed to test in healthy adults aged between 18-60     years the reactogenicity and immunogenicity of one and two administrations of a candidate     pandemic H5N1 vaccine formulated from Split Virus. The vaccines contain different antigen     doses . For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to     detect the optimal formulation for immunization against the H5N1 influenza strain.   "
188276|NCT00309647|"     Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian     virus. Prevention and control of a pandemic will depend on the rapid production and worldwide     distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be     developed and tested in clinical trials to determine the most optimal formulation and the     best vaccination schedule.This study is designed to test in healthy adults aged between 18-60     years the reactogenicity and immunogenicity of one and two administrations of a candidate     pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen     doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to     detect the optimal formulation for immunization against the H5N1 influenza strain.   "
188277|NCT00309660|"     Treatment with PPARgamma ligands have been shown to reduces intestinal inflammation in murine     models of colitis. The aim of this study was to evaluate the effect of treatment with local     PPARgamma ligand (rosiglitazone) in distal ulcerative colitis.The patients are treated with     rosiglitazone enema, once a day, for fourteen days. Disease activity was assessed before and     after treatment by endoscopical and clinical activity score.   "
188278|NCT00309673|"     The use of local anaesthesia efficiently reduces pain due to needle puncture. However, when     tuberculin skin test is performed it is the skin reaction to tuberculin injection that is     studied. It is a quantitative skin reaction measured in millimiters. From the study of     literature it is not known whether local anaesthetic modify skin reaction to tuberculin.     Therefore, before recommending the use local anaesthesia for tuberculin intradermal injection     we have to rule out a potential effect of local anaesthetic on the result of the test. This     is particularly important in children, since there are more sensitive to pain than adults   "
188279|NCT00309686|"     The purpose of this study is to evaluate the effectiveness and safety over a 6-week period of     paliperidone ER compared with placebo in treating subjects with Bipolar I Disorder who are     experiencing a manic or mixed episode while they are taking lithium or valproate. This study     will also evaluate the effect of paliperidone ER compared with placebo on overall     functioning, on how quickly a response is seen, on improvement in severity of illness, on     health-related functional status, on depressive symptoms, and on psychotic symptoms. The     relationship between blood levels and the effectiveness and safety of paliperidone ER will be     evaluated, including the effect of food relative to time of taking the drug.   "
188280|NCT00309699|"     The purpose of this study is to evaluate the effectiveness and safety of flexible-doses     paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with     Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also     evaluate the effects of paliperidone ER on global functioning, and will compare the     effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.   "
188281|NCT00309712|"     The primary study hypothesis of this study is to determine whether there is a greater     percentage of patients achieving a triglyceride level of <200 mg/dL with the combination of     simvastatin 20 mg and fenofibrate 160mg than with either simvastatin 20 mg monotherapy or     fenofibrate 160mg monotherapy.   "
188282|NCT00309725|"     The objective of this trial was to investigate the effect of galantamine (an     acetylcholinesterase inhibitor) on heart rate and PR interval (the time it takes for the     heart's electrical impulse to get from the atria to the ventricles) during the administration     of rapidly increasing doses and at the end of a 2-week treatment period with 32 mg per day in     patients with Alzheimer's disease.   "
188283|NCT00309738|"     The purpose of this study is to compare the efficacy and safety of pitavastatin with that of     simvastatin in patients with risk factors for heart disease.   "
188284|NCT00309751|"     The purpose of this study is to compare the efficacy and safety of pitavastatin with that of     atorvastatin in patients with type II diabetes mellitus (type II DM) and combined     dyslipidemia.   "
188285|NCT00309764|"     The overall objective of this study is to improve clinical outcomes and quality of life for     congestive heart failure (CHF) patients by integrating a readily available, low cost     technology – the telephone – into coordinated CHF care.   "
188286|NCT00309777|"     The purpose of this study is to compare the efficacy and safety of pitavastatin with that of     simvastatin.   "
188287|NCT00309790|"     Despite advances in medical therapy for patients with heart failure, one-third of patients     remain limited by fatigue and shortness of breath.      Our previous study concluded that one dose of sildenafil (Viagra) lead to an improvement in     heart pressure and exercise capacity.      Currently sildenafil is not FDA approved for the treatment of heart failure.      The purpose of this study is to determine if treatment with sildenafil for 12 weeks in     patients with heart failure can improve exercise capacity and quality of life in people with     heart failure.   "
188288|NCT00309803|"     Multicenter, prospective, study designed to demonstrate the performance and safety of the     Lumen Biomedical, Inc. FiberNet Embolic Protection System as an adjunctive device during     carotid artery percutaneous intervention. The primary endpoint is the rate of all stoke and     death within 30 days of the procedure.   "
188289|NCT00309816|"     The purpose of this study is to determine if sildenafil (Viagra) improves exercise tolerance.   "
188303|NCT00310011|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and cisplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel     and cisplatin works in treating patients with advanced transitional cell cancer of the     urothelium.   "
188290|NCT00309842|"     RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and     total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop     the growth of cancer cells and prepares the patient's bone marrow for the stem cells. When     the healthy stem cells from a donor are infused into the patient they may help the patient's     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving cyclosporine and mycophenolate mofetil may stop this from happening.      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide     together with total-body irradiation works in treating patients who are undergoing an     umbilical cord blood transplant for hematologic cancer.   "
188291|NCT00309855|"     This study is being done to understand how testosterone, the major male sex hormone, controls     the pituitary gland's secretion of growth hormone (GH). GH is an important metabolic hormone,     which controls sugar; fat and protein use in the body and maintains muscle strength and bone     calcium content. Both testosterone and GH decline in older men. The age-related fall in these     hormones probably contributes to relative frailty, reduced quality of life, bone loss, muscle     wasting and impaired sexual function.   "
188292|NCT00309868|"     We hypothesize that nesiritide will have favorable effect in decreasing heart filling     pressures and echocardiogram studies.   "
188293|NCT00309881|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as rituximab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Giving more than one drug (combination chemotherapy)     together with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with rituximab works in treating patients with chronic lymphocytic leukemia (CLL) that has     not responded to fludarabine (closed to entry as of 10/2006), CLL with autoimmune hemolytic     anemia, or Richter transformation.   "
188294|NCT00309894|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as     ketoconazole, may stop the adrenal glands from making androgens. GM-CSF may help ketoconazole     work better by making tumor cells more sensitive to the drug. Giving ketoconazole together     with hydrocortisone and GM-CSF may be an effective treatment for prostate cancer.      PURPOSE: This phase II trial is studying how well giving ketoconazole together with     hydrocortisone and GM-CSF works in treating patients with progressive prostate cancer after     hormone therapy.   "
188295|NCT00309907|"     This phase II trial is studying how well etanercept works in treating young patients with     idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Etanercept may     be effective in treating patients with idiopathic pneumonia syndrome after undergoing a donor     stem cell transplant.   "
188296|NCT00309920|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such     as darbepoetin alfa, may increase the number of immune cells found in bone marrow or     peripheral blood and may help the immune system recover from the side effects of     chemotherapy. Giving combination chemotherapy together with darbepoetin alfa after surgery     may kill any tumor cells that remain after surgery. It is not yet known whether combination     chemotherapy and darbepoetin alfa are more effective than combination chemotherapy alone in     treating stage III breast cancer.      PURPOSE: This randomized clinical trial is studying how well giving combination chemotherapy     together with darbepoetin alfa works compared to combination chemotherapy alone in treating     women with stage III breast cancer.   "
188297|NCT00309933|"     RATIONALE: Studying quality of life in breast cancer survivors may help determine the     long-term effects of breast cancer and may help improve the quality of life for future breast     cancer survivors.      PURPOSE: This clinical trial is studying quality of life in female breast cancer survivors     and their spouse, partner, or acquaintance.   "
188974|NCT00311428|"     This phase IV protocol is designed to evaluate the safety, clinical tolerability and     immunogenicity of the 2005-2006 formulation of three widely used conventional influenza     vaccines in children aged 6 to 35 months   "
188300|NCT00309972|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and vinorelbine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known     whether giving combination chemotherapy followed by radiation therapy is more effective than     giving combination chemotherapy together with radiation therapy followed by more chemotherapy     in treating non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by     radiation therapy to see how well it works compared to combination chemotherapy combined with     radiation therapy followed by more chemotherapy in treating patients with stage III non-small     cell lung cancer that cannot be removed by surgery.   "
188301|NCT00309985|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy     may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. It is not yet known whether androgen-ablation     therapy is more effective with or without docetaxel in treating metastatic prostate cancer.      PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and     chemotherapy to see how well they work compared to androgen-ablation therapy alone in     treating patients with metastatic prostate cancer.   "
188302|NCT00309998|"     RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor     cells by blocking blood flow to the tumor. Giving vinorelbine together with bevacizumab may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving vinorelbine together with     bevacizumab works in treating older patients with stage III or stage IV non-small cell lung     cancer.   "
188304|NCT00310024|"     This phase I trial is studying the side effects and best dose of vorinostat when given     together with bortezomib in treating patients with relapsed or refractory multiple myeloma.     Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Giving vorinostat together with bortezomib may kill more cancer cells   "
188305|NCT00310037|"     This randomized phase II trial studies how well bortezomib works when given after combination     chemotherapy, rituximab, and an autologous stem cell transplant in treating patients with     mantle cell lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving     more than one drug (combination chemotherapy) together with an autologous stem cell     transplant may allow more chemotherapy to be given so that more cancer cells are killed.     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Giving bortezomib after combination     chemotherapy, monoclonal antibody therapy, and an autologous stem cell transplant may kill     any remaining cancer cells or keep the cancer from coming back.   "
188306|NCT00310050|"     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes     needed for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high energy x-rays to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when     given together with radiation therapy in treating patients with locally advanced pancreatic     cancer.   "
188307|NCT00310063|"     RATIONALE: Using acupressure wrist bands to press and stimulate nerves at an acupressure     point on the inside of the wrist may help control nausea and vomiting caused by chemotherapy.      PURPOSE: This randomized clinical trial is studying how well acupressure works in preventing     nausea and vomiting in young cancer patients receiving chemotherapy.   "
188308|NCT00310076|"     RATIONALE: Thalidomide may stop the growth of tumor cells by blocking blood flow to the     tumor. Giving thalidomide after surgery and chemotherapy may kill any remaining tumor cells.      PURPOSE: This phase II trial is studying how well thalidomide works in treating patients who     have undergone surgery and received chemotherapy directly into the abdomen by hyperthermic     perfusion for cancer that has spread throughout the abdomen due to colorectal cancer or     appendix cancer .   "
188309|NCT00310089|"     RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as     doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD2171     together with combination chemotherapy before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed and may kill more tumor cells.      PURPOSE: This randomized clinical trial is studying how well giving AZD2171 together with     combination chemotherapy works in treating women with locally advanced breast cancer.   "
188310|NCT00310115|"     RATIONALE: Motivational counseling may help prevent pregnant women from smoking again after     pregnancy.      PURPOSE: This randomized clinical trial is studying three different types of counseling to     see how well they work in preventing smoking relapse after pregnancy in pregnant women who     quit smoking during pregnancy.   "
188369|NCT00297921|"     Prospective, nonrandomized, noncomparative, open-label, multicenter, 2-stage clinical study     designed to determine the overall response (combined complete remission, complete remission     with incomplete blood count recovery, partial remission, or blast response) rate following     tandutinib therapy in 2 groups of patients with newly diagnosed Acute Myelogenous Luekemia.   "
188311|NCT00310128|"     RATIONALE: Drugs used in chemotherapy, such as etoposide, methylprednisolone, cytarabine, and     cisplatin, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and yttrium     Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability     of cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them without harming normal cells. Giving more than one drug     (combination chemotherapy) together with rituximab and yttrium Y 90 ibritumomab tiuxetan may     kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed     or refractory AIDS-related non-Hodgkin's lymphoma.   "
188312|NCT00310141|"     RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and     computer-assisted counseling may help people stop smoking.      PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling     helps African American smokers stop smoking.   "
188313|NCT00310154|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib     together with docetaxel and radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when     given together with gefitinib and radiation therapy in treating patients with stage III     non-small cell lung cancer.   "
188314|NCT00310167|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet     known which regimen of low-dose radiation therapy is more effective in treating follicular     non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying two different regimens of low-dose     radiation therapy (24Gy versus 4Gy) to compare how well they work in treating patients with     follicular or marginal zone non-Hodgkin's lymphoma.   "
188346|NCT00310596|"     The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine)     injection has on the way the heart conducts the electrical impulses that allow it to beat     effectively. The study will compare Magnevist injection's effect to that of placebo (a saline     injection).   "
188316|NCT00310206|"     The purpose of this research study is to compare how the body reacts to different strengths     of an H5N1 flu vaccine when given by different routes of injection (injection into the skin     or into the muscle). It will also compare how antibodies (proteins produced by the body's     immune system that recognize and help fight infections and other foreign substances in the     body) are made after receiving the H5N1 flu vaccine. Participants will include 100 healthy     adults, ages 18-40 years. Study procedures include blood samples and completing a memory aid     documenting daily oral temperature and side effects for 7 days following each vaccination.     Participants may be involved in the study for up to 13 months.   "
188317|NCT00310219|"     RATIONALE: Imaging procedures, such as positron emission tomography (PET) scan and CT scan,     may help doctors plan radiation therapy for patients with non-small cell lung cancer.      PURPOSE: This clinical trial is studying how well a combined PET scan and CT scan works     compared to a CT scan alone in planning radiation therapy for patients with stage II or stage     III non-small cell lung cancer.   "
188318|NCT00310232|"     The general objective of this study is to improve the Quality of Life (QoL) of selected     patients with advanced carcinoma of the lung. The specific objective is to evaluate the     effect of treatment with epoetin alfa (recombinant human erythropoietin) on anemia related     QoL and anemia in non-small cell lung cancer patients with advanced stage disease and     underlying anemia of malignancy.   "
188319|NCT00310245|"     This is a single center, independent study. The primary objective is to compare efficacy and     safety of continuing a conventional HAART in chronically infected HIV patients with a     therapeutic strategy based on long term, immunologically driven treatment interruptions.     Evaluation will be based on clinical, immunological and virological response.      Patients will be randomized in a ratio 1:2 to one of the two treatment arms:      Control group continuing the ongoing therapy STI group performing long term CD4 guided     structured treatment interruptions In the STI arm patients will stay off therapy until their     CD4 count will drop < 400 cells/mcL. At that time point patients will resume the HAART     regimen they were assuming before STI and will continue HAART until they CD4 count will raise     > 800 cells/mcL and their HIV-RNA will drop below the detection limit of 50 copies/ml. When     both the CD4 count and the viral load will be within these pre-set values they will stop     therapy again. There is no limit to the number of interruptions and re-start cycles during     the study period The study is powered to evaluate equivalence between the two strategies     under the assumption of a failure proportion in the control arm at each time point not     greater than 5% and a maximum allowed difference of 15%.   "
188328|NCT00310362|"     Low endoscopy completion rates are a major problem in the VA, causing delay or failure to     receive essential care, increased clinic wait times, lost capacity, increased costs, thus     limiting endoscopic screening for colorectal cancer. This study tests whether an Interactive     Voice Response (IVR) messaging system is equally effective in promoting the completion of     flexible sigmoidoscopy and colonoscopy as usual clinical care practices that include phone     calls from nurses to patients prior to preparation and procedures. Previous studies have     examined the role of scheduling facilitation or patient adherence on endoscopy completion and     the use of IVR technology to enhance patient adherence in other medical contexts. This is the     first study, however, to evaluate the use of IVR for endoscopy completion and the first to     compare it to the effectiveness of phone calls from nurses prior to an endoscopy appointment.   "
188320|NCT00310258|"     This study will develop and test drug use prevention strategies for low-income, minority     girls. Gender-specific substance use rates, risk and protective factors, and health outcomes     highlight the need for interventions aimed at girls. Girls and boys share a number of risk     factors, yet some factors are more salient for one gender. Girls and boys may also be     affected differently by the same risk factors. Intervention planned for this study emphasizes     risk and protective factors that impact girls. Our intervention will build mother-daughter     communication and closeness; enhance girls' self-efficacy and body esteem; nurture girls'     conflict management, problem-solving, stress reduction, and refusal skills; correct perceived     norms; build social supports; and establish patterns of parental monitoring and supervision.     We hypothesise that girls who receive GSI will have lower 3-year follow-up rates of substance     use than girls who receive no intervention.      The study will occur in three phases. In a 12-month preparation phase, we will refine and     complete intervention and measurement protocols, recruit subjects and randomly assign girls     and mothers to study arms, and pretest girls and mothers. A 12-month implementation phase     will initiate field operations of the clinical trial, including intervention delivery,     process data collection, and posttests. Follow-up in the last 36 months will involve     longitudinal measurements of girls and mothers, booster session development and delivery, and     data analyses.   "
188321|NCT00310271|"     The purpose of this study is to evaluate how well the vaccine is tolerated at sites where     administrations are given and any effects it may have on subjects' wellbeing. The study will     also test the ability of vaccine to cause particular immune responses in the body.   "
188322|NCT00310284|"     The purpose of this study is to determine whether a handheld computer is superior to a     self-help manual for the treatment of chronic primary insomnia.   "
188323|NCT00310297|"     Primary objective:      To compare the pharmacodynamics of insulin glulisine and insulin lispro injected     subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects     with type 2 diabetes.      Secondary objectives:        -  To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese          subjects with type 2 diabetes, injected subcutaneously before three standard meals          during a 12-hour day.        -  The safety of insulin glulisine, the relationship of the pharmacodynamics and          pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid,          triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.   "
188347|NCT00310609|"     The purpose of this study is to look at the safety (what are the side effects) and efficacy     (how well does it work) of Magnevist (the study drug) used for MRI of the aortic arch and     cerebral branches. The results will be compared to the results of MRI taken without     Magnevist, and with the results of your X-ray angiography.   "
188348|NCT00297648|"     The aim of the study will be to investigate the effect of certolizumab pegol on the     intestinal mucosa in active Crohn's disease.   "
188324|NCT00310310|"     Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with     serious medical and psychological complications. Nasal continuous positive airway pressure     (CPAP) is the treatment of choice for this condition because it is highly effective in     reducing the frequency of nocturnal respiratory events, improving sleep architecture,     decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence,     however, limits the effectiveness of CPAP therapy and results in sub-optimal patient     outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest     improvements, have generally not been theory-driven, and have had minimal effects on key     patient outcomes such as reduction in OSA symptoms or increase in health-related quality of     life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management     Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that     requires significant self-care on the part of the patient. We draw on the extensive chronic     disease self-management literature to provide a solid theoretical justification for this     pragmatic intervention both to better manage key aspects of OSA and to increase CPAP     adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve     treatment adherence, and decrease medical utilization.   "
188325|NCT00310323|"     The purpose of this research study is to determine the effect of chronic nighttime low oxygen     saturations on selected body systems (liver) that break down drugs in children with     obstructive sleep apnea syndrome (OSAS).   "
188326|NCT00310336|"     50-60% of patients with chronic hepatitis C are not cured by treatment with pegylated IFNα     plus ribavirin.      Retreatment of non-responders of previous (pegylated) IFNα plus ribavirin therapies with     pegylated IFNα plus ribavirin results in a sustained response in less than 10% of the     patients.      Extensive analysis of IFNα signaling in cells expressing HCV proteins, in transgenic mice     expressing HCV proteins, and in liver biopsies from patients with chronic hepatitis C point     to STAT1 methylation as an important posttranslational modification targeted by HCV to     inhibit IFNα signaling.      STAT1 methylation can be increased and IFNα can be improved by adding AdoMet and betaine.      The study is designed to test the hypothesis that a combination treatment with pegylated     IFNα2b, ribavirin, AdoMet and betaine is superior to the current standard combination therapy     with pegylated IFNα plus ribavirin.   "
188327|NCT00310349|"     PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination     for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can     prevent ear disease in infants. Mothers will receive the 23 valent pneumococcal     polysaccharide vaccine (23vPPV) either: a) during the third trimester of pregnancy; b) soon     after child birth; or c) seven months after child birth (control group). The adult     diphtheria, tetanus and acellular pertussis vaccine (dTPa) will be used as the control     vaccine for the birth dose.      The study aims to recruit 210 Indigenous women aged 18-39 years who have an uncomplicated     pregnancy. Following recruitment, subjects will be randomly assigned to one of the three     groups.      Each mother and infant will be followed from pregnancy until the baby is seven months of age.     Children will receive all of their routinely recommended vaccinations in accordance with the     standard vaccination schedule.      The primary outcome will be prevalence of ear infection at seven months of age, defined as     middle ear effusion or tympanic membrane perforation or acute otitis media. Pneumatic     otoscopy, video-otoscopy and tympanometry will be used in the ear examinations. The primary     analyses will be a direct comparison of the proportion of infants in the control group who     have nasopharyngeal carriage of vaccine type pneumococci at seven months of age compared to     infants in each of the other two groups and a similar comparison of the proportion with     middle ear disease.   "
188329|NCT00310375|"     The purpose of this study is to evaluate the safety and tolerability of long-term therapy     with retigabine administered as adjunctive therapy in adult epilepsy patients with     partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of     long-term treatment with retigabine and patient quality of life will also be assessed.   "
188330|NCT00310388|"     This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind     VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet     inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an     adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation.     Treatment will be continued until the subject withdraws from the study or until the program     is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia,     and South Africa. The primary objective of the study is to evaluate the safety and     tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult     epilepsy patients with partial-onset seizures, who completed the double-blind Study     VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with     retigabine and patient quality of life and to evaluate whether retinal pigmentation,     unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of     nails, lips, skin or mucosa change over time after discontinuation of retigabine.   "
188331|NCT00310401|"     The purpose of this study is to test the effectiveness of albuterol versus placebo with the     following specific aims: a) Treatment of brain dead organ donors with albuterol will reduce     pulmonary edema, improve donor oxygenation, and increase the number of lungs available for     transplantation, b) Developing a blood test to predict the development of primary graft     dysfunction in lung transplant recipients, and c) treating brain dead organ donors with     albuterol will decrease markers of primary graft dysfunction and lead to improved lung     transplant recipient outcomes and to higher rates of lungs suitable for transplantation.   "
188349|NCT00297661|"     Context: Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal     stents, reduce the risk of restenosis. It is unclear whether there are differences in safety     and efficacy between the two types of drug-eluting stents.      Objective: To determine differences in safety and efficacy between sirolimus and paclitaxel     eluting stents.   "
188350|NCT00297674|"     The aim of this clinical trial is to clarify the clinical efficacy of clarithromycin as     immunotherapy for the management of septic syndrome by ventilator-associated pneumonia.   "
188351|NCT00297687|"     To determine the safety & immunogenicity of a potential vaccine against meningococcal B     disease   "
189758|NCT00321737|"     The purpose of this study is to assess the ability of once-daily (QD) treatment with     dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of     erosive esophagitis (EE).   "
188332|NCT00310414|"     This study will examine how the brain makes involuntary spasms and contractions in patients     with focal hand dystonia (FHD). Patients with dystonia have muscle spasms that cause     uncontrolled twisting and repetitive movement or abnormal postures. In FHD, only the hand is     involved. The study will use functional magnetic resonance imaging (fMRI, see below) to study     which areas of the brain are primarily affected in FHD and better understand how brain     changes produce dystonia symptoms.      Normal right-handed volunteers and patients with FHD who are 18-65 years of age may be     eligible for this study. Candidates are screened with a medical history and physical and     neurological examinations. Women who can become pregnant have a urine pregnancy test.      All participants undergo fMRI. This test uses a strong magnetic field and radio waves to     obtain images of body organs and tissues. The subject lies on a table that is moved into the     scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that     occur during the scanning process. The procedure lasts about 90 minutes, during which time     the patient is asked to lie still for 10-15 minutes at a time. During the procedure, subjects     are asked to perform some tasks, including writing, tapping with their hand, and drawing in a     zigzag motion. Each task is performed using the right hand, left hand and right foot.   "
188333|NCT00310427|"     This study will determine whether the experimental drug LY686017 can reduce a person's desire     for alcohol. A brain chemical called Substance P acts at places in the brain called NK1     receptors. Substance P is released in response to stress and gives rise to behaviors that are     thought to represent anxiety. LY686017 blocks Substance P from acting at the NK1 receptors.      People between 21 and 65 years of age who have been drinking on a regular basis for at least     one month before entering the study, who meet the criteria for alcohol dependence and who     have an elevated score on a general test of anxiety may be eligible for this study.      Participants are admitted to the NIH Clinical Center for 35 days. They participate in an     alcohol treatment program in addition to the research study. After having been withdrawn from     alcohol for at least 2 days, participants receive either 50 mg of LY686017 or placebo (an     inactive substance that looks like the study drug) every morning for 28 days. In addition to     drug treatment, they undergo the following procedures:        -  Functional magnetic resonance imaging (fMRI): In the last week of the study, subjects          undergo MRI to study the amount of blood going to brain structures thought to be          involved in anxiety and craving. During the procedure, they look at pictures of faces          exhibiting various emotions and pictures related to alcohol.        -  Cue reactivity: At the beginning and towards the end of the study, subjects are asked to          rate their alcohol craving and their anxiety level while they sniff and handle their          favorite alcoholic beverage or water.        -  Metyrapone test: During weeks 1 and 4 of the study, subjects are given metyrapone - a          drug that interferes with the body's ability to make the stress hormone cortisol - to          determine how LY686017 affects the body's hormonal response. The drop in cortisol from          metyrapone administration causes the brain to release ACTH, a hormone that causes the          adrenal gland to make cortisol.        -  Trier test: In the last week of the study, subjects give a 5-minute speech to three          people and are then asked to subtract numbers in their head. Then they are asked to rate          their feelings and desire for alcohol on two rating scales. Blood is drawn from a saline          lock at the beginning and end of the test to measure hormone levels.        -  Rating scales: Subjects complete an Obsessive Drinking Scale weekly and an Alcohol Urge          Questionnaire and Comprehensive Psychiatric Rating Scale twice a week.        -  Blood tests: Blood samples are collected periodically to check blood chemistries,          clotting time, and the amount of LY686017 in the blood.   "
188334|NCT00310440|"     The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not     inferior in effectiveness and safety to local autologous bone (control device) when applied     in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural     allograft ring in patients with degenerative cervical disc disease..   "
188335|NCT00310453|"     The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use     in children aged 5-12 years   "
188336|NCT00310466|"     The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of     birch pollen induced allergy   "
188337|NCT00310479|"     We seek to develop an advanced imaging approach to identifying and localizing prostate     cancer. We believe that high field MRI (magnetic resonance imaging) has the potential to do     this and we will endeavor to prove this by having patients with prostate cancer     pre-operatively undergo a technique called magnetic resonance spectroscopy. After surgery,     the microscopic locations of cancer will be compared with the pre-operative images to assess     how well the imaging technique succeeds.   "
188338|NCT00310492|"     This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment     of atopic dermatitis   "
188339|NCT00310505|"     This study is being conducted to assess the safety and efficacy of amphotericin B     deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given     in the conventional way every alternate day against the daily administration regimen being     tested.   "
188340|NCT00310518|"     The purpose of this study is to assess the overall response rate (ORR) of persistent,     recurrent or metastatic leiomyosarcoma in patients treated with ARQ 501.   "
188341|NCT00310531|"     The aim of this trial is to investigate whether the Menostar patch is as safe and effective     in the prevention of bone loss in postmenopausal women as raloxifen, a drug already     registered for prevention and treatment of osteoporosis.   "
188342|NCT00310544|"     The purpose of this study is to determine the dose of drug which is most effective in the     delineation of dead heart muscle.   "
188344|NCT00310570|"     Stubbing of the finger-tip is a common injury in sports such as basketball, volleyball,     cricket and football. This can result in a Mallet finger deformity, where the end joint of a     finger cannot be actively straightened out. In most mallet finger cases seen at The Alfred,     the skin remains intact, and the impairment results from a tear of the extensor tendon or an     avulsion (a small fracture where the tendon attaches to the bone). Treatment commonly     involves immobilising the end joint of the finger in a splint for six or more weeks so     patient compliance is a major factor in the quality of the outcome achieved.      This study aims to compare two different types of splintage (the commonly used thermoplastic     thimble splint and the aluminium-foam “Mexican hat” splint which is in use in Britain) with a     control splint (thermoplastic prefabricated “stack splint” with tape). Outcome measures will     include patient compliance with the splint, degree of extensor lag, active movement of the     joint, and any complications.      The null hypothesis is that there are no differences in outcome between different methods of     conservative splinting treatment for mallet finger.   "
188345|NCT00310583|"     The aim of this randomized placebo-controlled study is to evaluate the effects of analgetics     for neuropathic pain on mechanical hyperalgesia as a kind of evoked pain. Therefore the     number of responders and non-responders on pregabalin will be evaluated in respect of     mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking     pain determined via pinprick). The hypothesis is that in the placebo group the amount of     non-responders is increased.   "
189917|NCT00324961|"     This is a phase IV, 2-year, multi-center, single arm and open-label study, evaluating the     efficacy and safety with using local manufactured adefovir dipivoxil in Chinese subjects with     HBeAg negative chronic hepatitis B   "
188352|NCT00297700|"     Our goal is to test a dentist-hygienist team intervention to help dental patients quit     smoking and determine if it can be effectively and cost-effectively implemented and     sustained.      Staff in half of the HMO's 14 large dental facilities will be trained to provide brief     cessation advice and assistance and to encourage smokers to talk by phone with a tobacco     counselor before they leave the dental office. Phone counselors will provide brief     counseling, assess stage, and offer a full list of cessation services. The Active Referral     intervention strategy is both practical and innovative, as it takes advantage of available     resources; efficiently distributes intervention activities between dentists, hygienists, and     counseling specialists; and could be delivered in individual, small, or large dental     practices. This intervention is provided as part of routine care to all patients seen for     annual dental and periodontal exams.Consented patients will receive a short phone survey     shortly after the exam to assess smoking status, satisfaction with delivery of support     services,and satisfaction with intervention. Consented patients in treatment and control     facilities will be surveyed by phone at one year to re-assess smoking status and satisfaction     with services.   "
188353|NCT00297713|"     ALTU-238 is a long acting crystalline formulation of recombinant human growth hormone (rhGH)     that is being developed for the treatment of growth hormone deficiency in adults and     children. ALTU-238 is designed to require fewer injections than the currently available     formulations of rhGH.   "
188354|NCT00297726|"     This study will examine the efficacy of the Arthritis Self Managemnet Program (ASMP)and     determine changes in health resource utilization after completeing the ASMP program.   "
188355|NCT00297739|"     Primary objectives:        1. To assess the short-term efficacy of risperidone augmentation for treatment-resistant          aggression in children with ADHD.        2. To assess the short-term safety and tolerability of risperidone augmentation in the same          group of subjects.   "
188356|NCT00297752|"     The face is involved in 40-50% of patients with burns admitted to the Dutch Burn Centres.     Scarring of the face as a consequence of burns will often have a detrimental effect on     function and aesthetics, and may cause negative effects on psychosocial wellbeing. What the     best treatment is for facial burns, minimising scarring, is unclear. Besides that, there is     little empirical evidence regarding the impact of facial scarring on psychosocial wellbeing.      In clinical practice good results are felt to be achieved by treatment of facial burns with     flammacerium. To substantiate the perceived advantages of flammacerium, its efficacy is     compared to flammazine, a current alternative of care. The efficacy of treatment will be     assessed in a prospective randomised multicentre clinical trial. Efficacy will be analysed in     terms of number of patients requiring surgery and functional and aesthetic outcome.      Apart from medical outcome, this study offers the opportunity to study psychosocial problems     associated with facial defects. It is still an unresolved question whether facial scarring     causes more or different psychosocial problems. Therefore, self-esteem and quality of life     will be examined over time, in relation to depression, posttraumatic stress symptoms and     other factors, such as coping style and social support.      By evaluating the efficacy of different treatment strategies, we aim to optimise the standard     of care of facial burns. Furthermore, this study wants to shed more light on the psychosocial     impact of facial injury. With these results psychosocial professionals will be able to focus     on persons at risk and to be better able to meet a patient's personal needs.   "
188357|NCT00297765|"     A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of     kidney transplant patients.   "
188358|NCT00297778|"     Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the     brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the     brain (nerve cells) to control and harmonize muscle movements. Consequently, the main     manifestations of the disease affect movement and include tremor, muscular rigidity, slowness     in performing movements and loss of balance.      However, the disease affects also other, non motor functions and may cause other disorders,     such as depression. Depression may be a reaction to the disability caused by the disease, but     many studies show that depression is more common in PD than in other chronic debilitating     illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is     also used in brain circuits involved in the experience of pleasure, and loss of pleasure in     daily physical or social activity is one of the key manifestations of depression.      The objective of the study is to assess whether pramipexole, at doses approved for the     treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in     PD patients.      Also data on the safety of the product in the disease will be collected.   "
188359|NCT00297791|"     COLOR II is a randomized, international, multi center study comparing the outcomes of     laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent.     Clinical and operative data will be collected centrally in the coordinating centre in     Halifax, Canada. Quality of life and costs will be assessed on a national basis.   "
188360|NCT00297804|"     The clinical investigation is an international, prospective, multi-center, double-blind,     randomized safety and efficacy trial. The purpose of this study is to evaluate the safety and     effectiveness of the TAXUS(TM)Stent System with 1µg/mm2 (loaded drug/stent surface area) of     paclitaxel incorporated into a moderate rate-release formulation of triblock copolymer     carrier system in patients with a higher risk of target lesion revascularisation and     restenosis.   "
188361|NCT00297817|"     The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B     meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11     to 18 years.   "
188362|NCT00297830|"     The purpose of this study is to compare the effectiveness and safety of zoledronic acid with     alendronate in the prevention of bone loss after organ transplantation. Zoledronic acid is     given as a single intravenous infusion. Alendronate is given as a weekly pill. Both are     expected to be very effective, but it is not known which one will work best.   "
188379|NCT00303459|"     COMPASS-2 is a Phase 4, prospective, randomized, double-blind, placebo-controlled,     event-driven study evaluating the effect of bosentan on the time to first confirmed     morbidity/mortality event in patients with symptomatic PAH already receiving sildenafil     therapy. Patients must have been receiving doses of sildenafil equal to or greater than 20 mg     t.i.d. for at least 12 weeks prior to being randomized.      The study continued until the predefined target number of morbidity/mortality events was     reached.   "
188363|NCT00297843|"     Allergic Rhinitis is an inflammatory disease which causes an influx of inflammatory cells and     cytokines into the nasal mucosa. These biomarkers can also be found in the nasal secretions.     The evaluation of these inflammatory biomarkers is of great interest as this could lead to a     concept of measuring the efficacy of anti-allergic treatments by assessing the changes in     nasal biomarkers after allergen challenge. To use this model as an assessment of     pharmacodynamics it is crucial to evaluate the specificity and reproducibility of cellular     and cytokine levels in the nasal secretions after allergen provocations.      In a 2 part repeated measurement design 20 patients with allergic rhinitis and 20 healthy     subjects will undergo two 4-hour pollen exposures in an interval of 21 days.      The aim of this study is to explore the cellular and cytokine levels this allergen challenge     will induce in nasal secretions and to assess if an increase in those inflammatory biomarkers     is specific to the patient subgroup and whether the results are reproducible after the second     allergen challenge.   "
188364|NCT00297856|"     Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and     well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare     outcomes in a large population cohort. The Protocol Posting has been updated in order to     comply with the FDA Amendment Act, Sep 2007.   "
188365|NCT00297869|"     The subjects in this study are physicians working in the Wishard Emergency Department. The     purpose of this study is to measure the extent to which information technology     (i.e.-computers) improves emergency department care. The objective of our study is to     evaluate the use of informatics in the emergency department and specifically to determine if     computer reminder systems: 1) reduce the number of unsafe medications prescribed to older     adults, 2) assist in more safely dosing of medications to adults of all ages, and 3) increase     influenza immunization of eligible older patients in the emergency department.      Interventions: The interventions in this study are computer reminders. When releasing     patients from the emergency department, physicians currently write all release orders,     including prescriptions, on a computer order entry system that is linked to the Regenstrief     Medical Record System. The computerized order entry system will be programmed so that     physicians randomized (randomly placed) into the intervention group, the group that will     receive the intervention, they will receive one of three types of reminders:        1. The medication prescribed is generally considered unsafe for use in older patients. The          reminder will then list appropriate alternatives for this medication.        2. The dose of the prescribed medication is excessive and should be adjusted for the          patient's creatinine clearance (or kidney function).        3. This patient may be eligible for influenza vaccination.      The physician will then choose to order or disregard the recommendation. The computer system     will automatically record what the physician selected to do. The general outcome of interest     is the extent to which the electronic reminders successfully improved physician practice in     the emergency department setting. This outcome will be compared to physicians who were     randomized to the group that did not receive the reminders (the control group).   "
188366|NCT00297882|"     This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria     combination drugs (ACTs)for treatment of children aged 1-10 years in different locations in     Cameroon. Randomized clinical trials will provide local data on the safety of the test drugs,     and on putative marker mutations of the development of resistance to ACT. The study will     involve three centres, namely, Banso (Guinea-Savannah region), Limbe(Littoral Forest), and     Garoua(Sahel-Savannah). The trial will compare the efficacy and safety of     Amodiaquine(AQ)-Artesunate(Art) with Coartem®(Artemether-Lumefantrine). Drug efficacy will be     determined using a WHO standardised 28 day protocol. Safety will be monitored through     clinical examination, and biochemical and haematological indices. Molecular markers of     artemisinin resistance will be investigated by molecular sequencing and comparison of     parasite profiles of the PfATP6 gene in drug failure cases, . Recrudescences or re-infections     will be assessed by analysis of the msp1 and msp2 genes. The impact of these combinations on     generation of gametocytes will be determined from gametocyte carriage rates measured by     microscopy.   "
188367|NCT00297895|"     Subjects must be diagnosed with melanoma. All subjects receive sentinel lymphadenectomy. If     the subject is sentinel node positive and meets study requirements, the subject is randomized     to receive either (1) completion lymphadenectomy (2) observation with nodal ultrasound.     Subjects are then followed for 10 years.   "
188368|NCT00297908|"     Ethanol based hand sanitizers do not raise blood alcohol levels to a measurable amount. This     study will determine to what extent, if any, heavy use of ABHS changes blood alcohol levels.   "
188370|NCT00297934|"     The purposes of this study is to determined the effects of instrument applied spinal     manipulative therapy upon dual-task performance involving complex postural and cognitive     task.   "
188375|NCT00298012|"     The goal of this study is to evaluate the efficacy of oral methotrexate for the treatment of     active axial spondyloarthritis (early ankylosing spondylitis or spondyloarthritis with     sacroiliitis). Efficacy will be measured by reduction in the signs and symptoms of active     spondyloarthritis including effects on back pain and stiffness, range of motion in the spine,     physical function, quality of life and incidence of arthritis, enthesitis and anterior     uveitis.   "
188376|NCT00298025|"     To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and     Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing     ovarian stimulation with recombinant human follicle stimulating hormone/human menopausal     gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral     contraceptives pill (OCP) for cycle programming.   "
188377|NCT00298038|"     The purpose of this study is to determine if the study drug is safe and effective in     preventing Hepatic Encephalopathy (HE).   "
188378|NCT00303446|"     This study will determine if the drug dutasteride can improve weakness, mobility,     functioning, nerve function, and quality of life in patients with spinal and bulbar muscular     atrophy (SBMA). Patients with this inherited disease have an abnormal androgen receptor     protein. The male hormones testosterone and dihydrotestosterone (DHT) bind to this abnormal     receptor, causing damage to nerve cells that innervate muscle and leading to weakness.     Dutasteride decreases DHT production. Lowering DHT levels may decrease the harmful effects of     DHT to the nerves and improve strength in people with SBMA.      Males 18 years of age and older with SBMA who have neurological symptoms and can walk 100     feet (with or without assistive devices) may be eligible for this study. Candidates are     screened with a blood test and a review of their medical records and genetic studies.      Participants undergo the following procedures:        -  Blood and urine tests, history and physical examination, assessment of muscle strength        -  Quality-of-life questionnaire        -  Tests to assess functional abilities, such walking up steps, keeping the head up while          lying down, and other measures        -  Nerve conduction study and motor unit number estimation to assess nerve damage. A probe          placed on the skin delivers small electrical impulses and wires taped to the skin record          the impulses.        -  Quantitative muscle testing to measure strength. The subject pushes and pulls levers          attached to a gauge. Strength is recorded by a computer.        -  Medication. Participants are divided into two groups. One group is given the study drug,          dutasteride; the other receives a placebo (sugar pill). All participants take their          assigned medication once a day for 24 months.        -  Follow-up evaluations. Every 6 months for 2 years, participants return to NIH to repeat          the tests described above to determine the effects of the dutasteride. Nerve and          quantitative muscle testing is not done at the 6- and 18-month visits.        -  In addition to their follow-up appointments here at the NIH every 6 months, participants          will also have blood tests and a physical examination performed after 3, 9, 15 and 21          months of treatment by the patient's local physician.   "
188381|NCT00303485|"     This study will determine the rapidity of suppression of the bone resorption marker sCTX in     post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated.     Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with     vitamin D and calcium supplementation. The anticipated time on study treatment is     approximately 7 months, and the target sample size is <100 individuals.   "
188382|NCT00303498|"     The aim of this study was to determine whether long-term (≥ 6 months at the target dose)     blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with     chronic Heart Failure and an Left Ventricular Ejection Fraction ≥50%.   "
188383|NCT00303511|"     Review the feasibility, safety and outcomes in adults with congenital heart disease who     undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications   "
188384|NCT00303524|"     The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3     monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol     suppression in patients with oestrogen receptor positive early breast cancer.   "
188385|NCT00303537|"     The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty     liver disease.   "
188386|NCT00303550|"     The study is now completed   "
188387|NCT00303563|"     This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and     symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate     monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized     to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study     treatment is <3 months, and the target sample size is 100-500 individuals.   "
188388|NCT00303576|"     Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter     study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or     matching placebo gel. The volunteers will receive investigational product for a total of 42     days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and     compliance.   "
188389|NCT00303589|"     This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard     care' in patients with complicated skin and skin structure infections requiring     hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h     2)beta-lactam 1500mg iv q8h or 3)'standard care' [PRP (nafcillin or flucloxacillin) or     vancomycin, plus aztreonam or ciprofloxacin]. The anticipated time on study treatment is <3     months and the target sample size is 100-500 individuals.   "
188390|NCT00303602|"     This study is testing if under the tongue olanzapine for schizophrenia, related psychosis,     schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that     is swallowed, in patients who are already gaining weight on olanzapine.   "
188401|NCT00303771|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) in     different doses or combinations may kill more tumor cells. It is not yet known which     combination chemotherapy regimen is more effective in treating colorectal cancer.      PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with     leucovorin with or without irinotecan in treating older patients with metastatic colorectal     cancer .   "
188391|NCT00303615|"     This study is for patients with breast cancer that has spread to other tissues and organs.     The purpose of this study is to identify patients who may respond favorably to certain types     of hormonal therapy. Researchers will study your tumor, which was removed during your breast     surgery. They will look for the presence or absence of Androgen (AR) receptors. These tests     are for research purposes only. They will not affect the treatment of your breast cancer. The     presence or absence of Androgen receptors on the tumor does not alter the therapy that is     offered to patients. Recent evidence suggests that AR+ tumors are more likely to be destroyed     when treated with androgen drugs. We will ask about 35 ER-/PR- breast cancer patients from     Legacy Health System to be in this study. All tests and procedures are done as an outpatient     in the doctor's office, a clinic, or at the hospital. The study drug that will be used in     this trial is Androxy®, a synthetic androgen hormone. Androgens have been shown to inhibit     the growth of some breast cancer cells. Arimidex is an aromatase inhibitor that will be used     in conjunction with Androxy to inhibit the in vivo production of estrogen. It is hoped that     the combination of these two drugs will inhibit the growth of your tumor and possibly cause     it to shrink.   "
188392|NCT00303628|"     Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug     (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells     that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and     fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This     randomized phase III trial is studying combination chemotherapy to see how well it works with     or without bevacizumab in treating patients who have had surgery for stage II or stage III     rectal cancer.   "
188393|NCT00303641|"     The purpose of this study is to determine if the Medtronic Resting Heart Bypass system is     safer and results in less inflammatory reaction than traditional bypass machines used in     coronary artery bypass surgery. We hypothesize that the new Medtronic Resting Heart System is     safer and results in much less systemic inflammatory reaction in comparison to the standard     cardiopulmonary bypass systems currently in use.   "
188394|NCT00303654|"     RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer or     benign prostatic hyperplasia. Transurethral resection using a loop resectoscope may have     fewer side effects and improve recovery.      PURPOSE: This clinical trial is studying how well the loop resectoscope works in treating     patients with bladder cancer or benign prostatic hyperplasia who are undergoing transurethral     resection.   "
188395|NCT00303667|"     RATIONALE: Giving chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total     body irradiation, before peripheral blood stem cell transplant helps stop the growth of     cancer cells. It may also stop the patient's immune system from rejecting the donor's stem     cells. When the healthy stem cells and natural killer (NK) cells from a donor are infused     into the patient they may help the patient's bone marrow make stem cells, red blood cells,     white blood cells, and platelets. Giving IL-2 (aldesleukin) after NK cell infusion may     stimulate them to kill any remaining cancer cells.      PURPOSE: This phase I/II (currently enrolling in phase II) trial is studying how well a donor     natural killer cell infusion works in treating patients who are undergoing donor stem cell     transplant for acute myeloid leukemia.   "
188396|NCT00303706|"     The purpose of this study is to compare the safety and effectiveness of minimally invasive     endoscopic harvest of the radial artery to the conventional open method of radial artery     harvest in coronary artery bypass surgery. The researchers hypothesize that the radial artery     can be safely, efficiently, and routinely harvested using a minimally invasive endoscopic     technique. Endoscopic minimally invasive harvesting of the radial artery will reduce the     postoperative morbidity due to pain, wound infection, and neurological complications and     improve cosmetic results.   "
188397|NCT00303719|"     RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that     were destroyed by chemotherapy and radiation therapy, or that have become cancer. Sometimes     the transplanted cells from a donor can make an immune response against the body's normal     cells. Giving cyclophosphamide and fludarabine together with total-body irradiation followed     by cyclosporine and mycophenolate mofetil before the transplant may stop this from happening.      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together     with radiation therapy followed by cyclosporine and mycophenolate mofetil works in treating     patients who are undergoing a donor stem cell transplant for hematologic cancer, metastatic     breast cancer, or kidney cancer.   "
188398|NCT00303732|"     RATIONALE: Vatalanib and everolimus may stop the growth of tumor cells by blocking blood flow     to the tumor and by blocking some of the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib and     everolimus and to see how well they work in treating patients with advanced solid tumors.   "
188399|NCT00303745|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It     is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone     in treating colorectal cancer.      PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how     well they work as second-line therapy compared to irinotecan alone in treating older patients     with progressive, metastatic colorectal cancer that cannot be removed by surgery.   "
188400|NCT00303758|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and     gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     and giving them in different ways may kill more tumor cells. It is not yet known which     combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.      PURPOSE: This randomized phase III trial is studying two different combination chemotherapy     regimens to compare how well they work in treating patients with metastatic pancreatic cancer     that cannot be removed by surgery.   "
188402|NCT00303784|"     RATIONALE: The increasingly prolonged and extended use of androgen deprivation therapy (ADT)     in the treatment of prostate cancer, usually achieved through the administration of LHRH     agonists, has raised concerns about long-term toxicities, in particular osteoporosis and     adverse metabolic changes which may be associated with type II diabetes and increased     cardiovascular risk. An alternative approach is to investigate other methods of ADT. Oral     oestrogen has been shown to be as effective as LHRH and surgical orchidectomy in achieving     castrate levels of testosterone and has equivalent or improved prostate cancer outcomes but     is not used routinely as first-line therapy because of the risk of cardiovascular system     (CVS) complications. The CVS complications have been attributed to first-pass hepatic     metabolism. Administering oestrogen parenterally avoids the entero-hepatic circulation and so     is expected to mitigate the risk of CVS toxicity whilst still effectively suppressing     testosterone to castrate levels. This hypothesis has been supported by results from the early     stages of this trial which have provided sufficient indication of the safety and efficacy of     the patches to warrant further investigation of the treatment in this setting, as recommended     by the IDMC..      PURPOSE: This randomized phase III trial is studying how well the estrogen skin patch works     compared with luteinizing hormone-releasing hormone agonist injections in treating patients     with locally advanced or metastatic prostate cancer.   "
188403|NCT00303797|"     This phase I trial is studying the side effects and best dose of sorafenib and bortezomib in     treating patients with advanced cancer. Sorafenib and bortezomib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop     the growth of cancer cells by blocking blood flow to the cancer   "
188404|NCT00303810|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving radiation therapy in different ways and     giving it together with more than one drug (combination chemotherapy) may kill more tumor     cells. It is not yet known which radiation therapy and combination chemotherapy regimen is     more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor     (PNET), or ependymoma.      PURPOSE: This clinical trial is studying six different radiation therapy and combination     chemotherapy regimens to compare how well they work in treating young patients with     medulloblastoma, PNET, or ependymoma.   "
188443|NCT00304382|"     The purpose of this study is to determine whether there are differences in the level of     antibody to capsular polysaccharides of S. pneumoniae or the physiological activity of such     antibody after vaccinating patients who have recovered from pneumococcal pneumonia with     pneumococcal polysaccharide vaccine (Pneumovax) or conjugate pneumococcal vaccine (Prevnar).   "
188405|NCT00303823|"     This randomized phase II trial is studying green tea extract to see how well it works     compared to a placebo in preventing cervical cancer in patients with human papillomavirus and     low-grade cervical intraepithelial neoplasia. Chemoprevention is the use of certain     substances to keep cancer from forming, growing, or coming back. The use of green tea extract     may stop cervical cancer from forming in patients with human papillomavirus and low-grade     cervical intraepithelial neoplasia. It is not yet known whether green tea extract is more     effective than a placebo in preventing cervical cancer in patients with human papillomavirus     and low-grade cervical intraepithelial neoplasia.   "
188406|NCT00303836|"     This randomized phase II trial is studying how well giving vaccine therapy with or without     interleukin-2 after chemotherapy and an autologous white blood cell infusion works in     treating patients with metastatic melanoma. Vaccines made from peptides may help the body     build an effective immune response to kill tumor cells. Giving vaccine therapy with     interleukin-2, chemotherapy, and an autologous white blood cell infusion may be a more     effective treatment for metastatic melanoma.   "
188407|NCT00303849|"     This phase I/II trial studies the side effects and best dose of melphalan when given together     with carboplatin, etoposide phosphate, mannitol, and sodium thiosulfate and to see how well     they work in treating patients with previously treated brain tumors. Drugs used in     chemotherapy, such as melphalan, carboplatin, and etoposide phosphate, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Osmotic blood-brain barrier disruption (BBBD) uses mannitol to open the blood     vessels around the brain and allow cancer-killing substances to be carried directly to the     brain. Sodium thiosulfate may help lessen or prevent hearing loss and toxicities in patients     undergoing chemotherapy with carboplatin and BBBD. Giving carboplatin, melphalan, etoposide     phosphate, mannitol, and sodium thiosulfate together may be an effective treatment for brain     tumors.   "
188408|NCT00303862|"     This phase II trial is studying how well AZD2171 works in treating patients with refractory     metastatic kidney cancer. AZD2171 may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.   "
188409|NCT00303875|"     RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and     quality of life in older long-term cancer survivors who are overweight.      PURPOSE: This randomized clinical trial is studying two different schedules of exercise and     dietary counseling to compare how well they work in improving physical activity, nutrition,     and quality of life in older long-term cancer survivors who are overweight.   "
188410|NCT00303888|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Phenoxodiol may help docetaxel work better by making tumor cells more sensitive to the drug.      PURPOSE: This randomized phase I/II trial is studying the side effects of docetaxel when     given together with either phenoxodiol or placebo and to see how well it works in treating     patients with recurrent advanced ovarian epithelial cancer, fallopian tube cancer, or primary     peritoneal cavity cancer.   "
188411|NCT00303901|"     RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment     for primary lung cancer or lung metastases that cannot be removed by surgery.      PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with     primary lung cancer or lung metastases that cannot be removed by surgery.   "
188412|NCT00303914|"     RATIONALE: Questionnaires that assess symptoms caused by cancer and cancer therapy may help     improve the ability to plan treatment for patients with invasive cancer to help them live     longer and more comfortably.      PURPOSE: This clinical trial is studying symptoms caused by cancer and cancer therapy in     patients with invasive breast, lung, prostate, or colorectal cancer.   "
188457|NCT00304577|"     Infantile esotropia is corrected in most cases by bilateral recession of the medial rectus     muscles (BR) or by unilateral recession of the medial rectus muscle and resection of the     lateral rectus muscle (RR). We compared the outcome of these techniques in a randomized     prospective study.   "
188413|NCT00303927|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well capecitabine works as second-line therapy     in treating patients with stage IV pancreatic cancer who have the thymidylate synthase gene.   "
188414|NCT00303940|"     RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as temozolomide and carboplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving talabostat together with temozolomide or carboplatin may     kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of talabostat when     given together with temozolomide or carboplatin in treating young patients with relapsed or     refractory brain tumors or other solid tumors.   "
188415|NCT00303953|"     This phase II trial is studying how well PXD101 works in treating patients with relapsed or     refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to     the cancer.   "
188416|NCT00303966|"     Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the cancer. This phase II trial is studying how well     sorafenib works in treating patients with relapsed chronic lymphocytic leukemia.   "
188417|NCT00303979|"     The purpose of this study is to characterize current management of patients with either heart     failure or prior myocardial infarction and left ventricular dysfunction and to assess the     effect of education, specific clinical guidelines, reminder systems, comprehensive disease     state management tools, benchmarked quality reports, and academic detailing on the use of     evidence-based heart failure therapies in cardiology practices. This study is a quality     improvement initiative that is being conducted through review of patient records.   "
188444|NCT00304395|"     The purpose of this research is to identify cases from patients who have been referred for     consultation to the Infectious Disease Section at the VAMC, Houston, and to compare them with     other cases of CAP in order to determine whether there are features that might enable non-CAP     cases to be distinguished from CAP.   "
188418|NCT00303992|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     irinotecan, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving trastuzumab together with irinotecan may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving trastuzumab together with irinotecan     works in treating patients with HER2/neu positive metastatic breast cancer.   "
188419|NCT00304005|"     RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M and to     see how well it works in treating patients with Richter syndrome or refractory or relapsed     chronic lymphocytic leukemia or other lymphoproliferative disorders.   "
188420|NCT00304018|"     RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and etoposide, before a donor     umbilical cord blood stem cell transplant helps stop the growth of cancer cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving antithymocyte globulin before transplant and tacrolimus and prednisone after     transplant may stop this from happening.      PURPOSE: This phase I trial is studying how well donor umbilical cord blood transplant works     in treating patients with advanced hematologic cancer.   "
188421|NCT00304031|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving radiation therapy     together with temozolomide may kill more tumor cells. It is not yet known which schedule of     temozolomide when given together with radiation therapy is more effective in treating     glioblastoma or gliosarcoma.      PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide     to compare how well they work when given together with radiation therapy in treating patients     with newly diagnosed glioblastoma or gliosarcoma.   "
188422|NCT00304070|"     This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or     surgery works in treating young patients with stage I, stage II, stage III or stage IV     adrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.     Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain     after surgery.   "
188423|NCT00304083|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and etoposide, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving combination chemotherapy with or without radiation therapy before surgery may make the     tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving     combination chemotherapy after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating     patients with stage III or stage IV malignant peripheral nerve sheath tumors.   "
188424|NCT00304096|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells. Giving booster vaccinations may make a stronger immune response and kill     more tumor cells.      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating     patients with stage III or stage IV breast cancer.   "
188439|NCT00304317|"     The purpose of this trial is to quantify the amount Celebrex, a specific cyclooxygenase-2     (COX-2) inhibitor, when used for the management of acute renal colic for a ureteral stone     will:        -  reduce pain medication usage        -  improve the percentage of spontaneous stone passage        -  decrease the time to spontaneous passage, and        -  shift the size distribution of stones passed towards larger sizes   "
188480|NCT00310713|"     Persistence of antibodies and kinetics of B cell response in healthy children after     vaccination with MCC vaccine   "
188425|NCT00304135|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and     gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It     is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is     more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic     biliary tract cancer.      PURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and     radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in     treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.   "
188445|NCT00304408|"     The purpose of this study is three fold: 1)To collect serum from patients with documented     Clostridium difficile infection and test for the presence of antibody to C. difficile toxin     at the start and at the end of therapy, and again if a relapse or recurrence occurs. 2)To     collect stool samples for test of C. difficile toxin at similar time intervals. 3)To assay     random serum samples from the VA lab in order to determine the rate of antibody to C.     difficile toxin in our patient population.   "
188446|NCT00304421|"     The purpose of the study is to compare the effect of two different drugs, rabeprazole (20 mg)     and pantoprazole (40 mg), and their effects on the amount of acid produced by your stomach on     evening and at night after standard protein meal.   "
188447|NCT00304434|"     Objective 1: Determine the safety and toxicity profile of Tamiflu administered in combination     with probenecid in healthy adults.Objective 2: Determine the pharmacokinetic profile of     Tamiflu and probenecid in healthy adults.   "
188487|NCT00310804|"     The present study aims to evaluate safety, tolerability and immunogenicity of three lots of     Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a     conventional egg-derived control vaccine licensed in Europe.   "
188426|NCT00304148|"     Insights into the cause of kidney failure have emerged from research, but less is known about     the epidemiology of less severe forms of kidney disease known both as chronic kidney disease     (CKD) or chronic renal insufficiency (CRI).      The Chronic Renal Insufficiency Cohort (CRIC) Study was established to study the consequences     of CKD with a particular focus on cardiovascular illness like myocardial infarction (heart     attack) and stroke. The CRIC Study will identify high-risk subgroups of individuals with CRI,     informing future treatment trials, and development of preventive therapies.      CRIC is an observational study that to date, 3612 participants have been enrolled in the CRIC     cohort. The goal for Phase III is to enroll 1500 new participants across all seven Clinical     centers (214 new participants per center). Participants previously enrolled will be followed     for an additional 5 years and newly recruited participants will be followed for up to an     additional 5 years. Principles underlying the targeted composition of the cohort of new     recruits are very similar as the Phase I recruits, however with some modifications as listed     below in the eligibility summary.      No study treatments or interventions will be given to participants in CRIC. Subjects will     include a racially and ethnically diverse group of adults aged 45 to 79 years old with a     broad spectrum of renal disease severity and proteinuria levels. Participants who are 65     years or older will undergo additional testing to assess physical and cognitive function,     social support, and quality of life.   "
188427|NCT00304161|"     This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression     in people with Parkinson's disease.   "
188428|NCT00304174|"     This study will evaluate whether people with bulimia nervosa will binge eat in a structured     laboratory setting and display behavioral patterns similar to those of individuals who are     dependent on drugs.   "
188429|NCT00304187|"     This study will determine the effectiveness of the antibiotic erythromycin in enhancing     gastrointestinal function and decreasing the frequency of binge eating in people with bulimia     nervosa.   "
188430|NCT00304200|"     This study is designed to evaluate the safety and appropriate dose of the combination of     Temodar and Sutent as first-line therapy for patients with metastatic malignant melanoma     (Phase 1). Once the safety and appropriate dose is determined, additional patients will be     studied at that dose to determine if there is clinical benefit as determined by the primary     end-point of progression-free survival (PFS) at 6 months and additional secondary endpoints     (Phase II).   "
188431|NCT00304213|"     This is a randomized controlled trial of testosterone replacement therapy in hypogonadal men     age > 60 years. The goal is to assess the safety and efficacy of TRT in men age > 60 years.   "
188432|NCT00304226|"     The population for this current study will include stage 1 and stage 2 hypertensive patients     who are newly diagnosed or didn't have treatment during the last 3 months and patients who     are currently treated but uncontrolled on present monotherapy.      The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a     treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.   "
188433|NCT00304239|"     The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with     methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the the LED light source     Aktilite CL128, in treatment of patients with multiple actinic keratosis (sun-damaged skin)     on the face and / or scalp.   "
188434|NCT00304252|"     The purpose of this study is to determine the safety and efficacy of interferon beta-1a in     maintaining remission in patients with Crohn's disease.   "
188435|NCT00304265|"     Post-marketing evaluation of reactions following receipt of recommended adolescent pertussis     vaccine among persons with prior vaccination with acellular vs whole-cell pertussis vaccine.      To describe and characterize adverse events occurring after vaccination with REPEVAX®     (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated     poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular     pertussis) vaccine among two groups: Group 1 - adolescents 10-14 years of age who     participated in study 371-03/01 (and thus received a 5th dose of TRIPEDIA® vaccine) and Group     2 - controls 10-14 years of age who were vaccinated with at least three doses of a whole-cell     pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their     2nd through 7th year of life.   "
188436|NCT00304278|"     The purpose of this study is to determine the safety and effectiveness of treatment with     Tarceva (Erlotinib) and RADPLAT (RADiation and intraarterial cisPLATin) for patients with     Head and Neck cancer   "
188437|NCT00304291|"     Neuromyelitis optica (NMO) is a severe demyelinating disease that selectively involves the     optic nerves and the spinal cord but usually spares the brain. NMO is considered to have a B     cell induced pathogenesis. Mitoxantrone (MITO, Novantrone®), a synthetic anthracenedione     approved for worsening relapsing-remitting multiple sclerosis (MS) and secondary progressive     MS, has been shown to primarily suppress the humoral response. We conducted a prospective     2-year study to evaluate the benefit of MITO in five relapsing NMO patients.   "
188438|NCT00304304|"     From a previous community needs survey, we determined that asthma was a particular problem in     our community-based research network of child care centers. This study will examine whether a     moderate intervention can help these centers improve their asthma-friendly rating as per     NHLBI guidelines. We will both center directors and parents to establish baseline data on     child health and the asthma-friendliness of each center. We will use a wait-list control,     with all centers eventually receiving the intervention.   "
188515|NCT00319007|"     The purpose of this study is to determine whether sulindac and VSL#3 - inulin, either     combined or alone, are effective in treating or preventing adenoma development in the ileal     anal pouch in patients with familial adenomatous polyposis.   "
188440|NCT00304330|"     The information collected will provide insight in to the epidemiology of antibiotic     resistance in a transplant compared to a non-transplant population. Data is needed regarding     the date of admission, date of bloodstream infection and location of ward/ICU so trends in     the emergence of resistance and antibiotic usage can be detected.   "
188441|NCT00304356|"     The purpose of this study is for compassionate use of nitazoxanide in the treatment of     diarrheal disease due to Clostridium difficile infection when the patient has failed previous     treatment with metronidazole or vancomycin.   "
188442|NCT00304369|"     In this record review study, our objective is to determine the rates of cure, failure and     relapse following treatment of C. difficile colitis with metronidazole.   "
188448|NCT00304447|"     The purpose of this study is to evaluate the effect of corticosteroids on the frequency and     severity of Mylotarg® infusion-related adverse events, to evaluate the effect of     corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete     response with incomplete platelet recovery (CRp) at one-month post treatment.   "
188449|NCT00304460|"     Background:      -Although IL-2 can shrink tumors in about 20 percent of patients with metastatic kidney     cancer and in 15 percent of patients with metastatic melanoma, it is not fully known how the     drug works.      Objectives:      -To better understand how IL-2 causes tumors to shrink.      Eligibility:      -Patients 18 years of age or older with metastatic kidney cancer or metastatic melanoma      Design:        -  135 patients with melanoma and 110 patients with kidney cancer may be enrolled.        -  Patients are hospitalized for about 7 days for each treatment. They receive IL-2          intravenously (through a vein) over 15 minutes every 8 hours for up to 4 days or 12          doses. This constitutes one treatment cycle.        -  Research blood samples are collected daily during the first treatment cycle and for one          or two days following the last dose.        -  Patients may be asked to undergo leukapheresis, a procedure for collecting large          quantities of white blood cells. This involves collecting blood through a needle in an          arm vein. The blood is directed through a cell separator where the white cells are          extracted. The rest of the blood (red cells, platelets, and plasma) is returned to the          patient through the same needle or through a needle in the other arm.        -  About 7-10 days after discharge from the hospital, patients return for a second          treatment cycle but without research blood sampling.        -  2 months after therapy, patients are evaluated with scans, and x-rays, and blood tests          to evaluate the tumor and the effects of the treatment on immune cells.        -  Patients whose tumors shrink or remain stable may continue treatment (without repeating          the full set of research blood samples) as long as they benefit from the treatment and          do not develop unacceptable side effects. Patients who continue treatment are evaluated          every 2 months for 3 to 4 times and then every 3 to 6 months.   "
188450|NCT00304473|"     Assess the efficacy of a fast titration of quetiapine to the current titration approved by     the regulatory authorities.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
188451|NCT00304499|"     The purpose of this study is to compare the side-effect profile and efficacy of sustained     release, OROS® and TTS, dosage forms of oxybutynin with immediate release (IR) oral     oxybutynin and with placebo.   "
188452|NCT00304512|"     The purpose of this study is to determine whether AT1001 (migalastat hydrochloride) is safe     and effective in female patients with Fabry disease.   "
188453|NCT00304525|"     The purpose of this study is to determine the safety profile, pharmacokinetics,     pharmacodynamics and maximum tolerated dose of RAF265 in patients with locally advanced and     metastatic melanoma.      Phase II portion of study (dose expansion) has been cancelled with Amendment 7 as of Dec     2011.   "
188454|NCT00304538|"     The purpose of this study is to identify the safest dose of very low dose glucagon to prevent     hypoglycemia in patients with Type I diabetes who use insulin pumps and to measure the the     amount of glucagon in the blood and see how the body responds to the glucagon.   "
188455|NCT00304551|"     This study evaluated the clinical response of the efficacy and safety of the combination     therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free     group in CHC patients with compensated LC.      Additionally, this study evaluated the dosage reactivity and the pharmacokinetic     characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC     patients with compensated LC.   "
188456|NCT00304564|"     Falls are the largest cause of death in the elderly and those in nursing homes have even a     higher incidence of falling. The purpose of this study is to determine whether listening to     the Music of Nolwenn Leroy daily is effective in fall prevention in those elderly patients     who are residents in several Texas geriatric nursing home facilities. The music of Nolwenn     Leroy has been shown to be effective in fall reduction in a different setting (Posturographic     Changes and Fall Prevention associated with Music Therapy: The Nolwenn Effect (USA     ClinicalTrials.gov Identifier: NCT00121693) )with results better than listening to Mozart of     any other music. Another similar study (USA ClinicalTrials.gov Identifier:NCT00272272)is     presently being conducted in a geriatric nursing home facility in Georgia. Dynamic     posturographic measurments will be obtained from all residents and compared to normative age     related data and utilized to measure stability changes in this study.   "
188654|NCT00320827|"     This is a dose escalation study of CS-1008 (humanized anti-DR5 antibody) to determine the     recommended Phase 2 dose and the maximum tolerated dose. Drug will be administered for six     weeks and possibly up to 12 weeks depending on response.   "
188458|NCT00304590|"     This clinical study is being conducted at multiple sites to determine the activity, safety,     and tolerability of XL999 when given weekly to patients with relapsed or refractory multiple     myeloma. XL999 is a small molecule inhibitor of cellular factors including VEGFR, PDGFR, and     FGFR that may be involved in multiple myeloma.   "
188459|NCT00304603|"     The purpose of this study is to explore the mode of action of topiramate in the treatment of     obese and diabetic patients by testing association between genetic variations within     candidate genes or chromosomes (thread like structure found in cell which carries genes) and     the clinical outcomes.   "
188460|NCT00304616|"     To evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole     administration   "
188461|NCT00304629|"     The long-term safety and efficacy of galantamine (12 mg bid) will be documented during a one     year open-label treatment in subjects with Alzheimer's Disease who completed the GAL-INT-8     trial (up to 400 eligible patients). Safety will be tracked by means of adverse event     reports, laboratory parameters and physical exam. Long-term efficacy will be evaluated by     means of a Alzheimer's Disease Assessment Scale(ADAS) and activities of daily living scale     Disability Assessment for Dementia Scale(DAD)   "
188462|NCT00304642|"     Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase     I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of     dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy     HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive     2.5mL dapivirine vaginal microbicide gel at one of three concentrations.   "
188463|NCT00304655|"     The purpose of this study is to prove safety and efficacy of aripiprazole.   "
188464|NCT00304668|"     Approximately 42 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each     volunteer will have a 2:1 chance of receiving Dapivirine Gel-002 versus placebo. The     volunteers will receive investigational product for a total of 42 days.   "
188465|NCT00304681|"     The purpose of this study is to determine the effectiveness and safety of     OROS*methylphenidate/CONCERTA* vs. immediate release methylphenidate as a treatment for ADHD     specifically for those children who have behavioural difficulties in the     afternoon/after-school and evening periods.   "
188466|NCT00304694|"     18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively     detect subclinical and clinical therapeutic responses at stages that are earlier than those     detected by conventional approaches.      We propose to conduct a prospective study to evaluate therapeutic response using 18F-FDG PET     before and after induction chemotherapy for locally advanced NPC patients.   "
188467|NCT00304707|"     Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment     for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate     the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving     treatment for alcohol dependence.   "
188468|NCT00304720|"     Primary Objective:      A. To determine whether stable allogeneic hematopoietic engraftment can be safely established     in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor, with     fludarabine and low-dose TBI, with pre- and post-transplant immunosuppression with tacrolimus     and MMF.      B. To evaluate the incidence of grade II-IV GVHD associated with this treatment.   "
188469|NCT00304733|"     Objective: to compare the effectiveness of irremovable total contact casts and custom made     temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes   "
188470|NCT00304746|"     We hypothesize that AndroGel may offer some relief to subjects with low or borderline     testosterone levels who suffer from depression and have failed to respond to a trial of a     standard antidepressant.      During this nine week, outpatient, double-blind study, male subjects between the ages of 30     and 65 years with treatment-refractory depression and low or borderline low testosterone     levels will be treated with either AndroGel or placebo. Following this nine week,     double-blind phase, eligible subjects will have the option to continue into a six month,     open-label phase during which time all subjects will receive the AndroGel patch.   "
188471|NCT00304759|"     This trial is designed to determine whether an 8-week course of escalated dose conformal     radiation can be compressed safely, and with similar efficacy into a 4-week course.   "
188472|NCT00304772|"     The purpose of this study is to verify the equivalence in clinical efficacy of fluconazole     and micafungin for the treatment of Candida bloodstream infection in non-neutropenic     patients.   "
188473|NCT00310622|"     The purpose of the study is to verify the ability of the HyperQ signal to detect Dobutamine     induced Ischemia. The gold standard for ischemia will be the results of Angiography if     performed, or Echocardiographic imaging, which was performed during the test.   "
188474|NCT00310635|"     Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32     to 40 Months of Age   "
188475|NCT00310648|"     Clinical Trial in Two parts:      Part 1: Phase I, Open-Label, Single-Center Study to Evaluate the Safety of an adjuvanted     Influenza Vaccine When Administered to Elderly Subjects.      Part 2: A Phase III, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate     the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When     Administered to Elderly Subjects.   "
188476|NCT00310661|"     TD is a troublesome and potentially irreversible side effect associated with the use of     neuroleptics. While the newer neuroleptics are improved in this regard, they all still carry     the risk of TD.      The present study proposes that sarizotan is a potential agent for treating     neuroleptic-induced TD based on preliminary data indicating efficacy in the management of     dyskinesias associated with Parkinson's disease. Its efficacy is further substantiated by     pre-clinical data obtained from the vacuous chewing movement (VCM) model in rats, a model we     employ ourselves in investigating the relationship between D2 occupancy and TD. The present     study also examines the effects of sarizotan on cognitive function, given the association     between TD and cognitive deficits.   "
188477|NCT00310674|"     Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine     Administered to Healthy Premature and Non Premature Children of 3 months of age   "
188478|NCT00310687|"     Persistence of Immune response after vaccination with MCC   "
188479|NCT00310700|"     Kinetics of B cell response in infants Menjugate vaccination   "
188481|NCT00310726|"     The study is designed as a randomized, controlled trial with specific observational     objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be     counselled to exclusively breastfeed through 4 months of age. All live-born children will be     randomized (1:1) at birth to one of two counseling programs: A) to encourage abrupt weaning     at 4 months of age, or B) to encourage exclusive breastfeeding through 6 months of age with     the introduction of typical weaning foods ad lib.   "
188482|NCT00310739|"     We previously reported early measurement of urinary MDA might be a useful marker for the     prediction of CDDP-induced renal damage in rat. The purpose of this clinical study is to test     whether the changes of human urinary excretion of MDA, and can be used as early biomarker for     the prediction of development of CDDP-induced ARF.   "
188483|NCT00310752|"     The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the     management of chronic wounds.      Other goals of this study are to gain feedback from patients and healthcare providers on the     ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the     efficacy of DermaStream(tm) in chronic wound management.   "
188484|NCT00310765|"     The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in     abdominal pain from adhesions.   "
188485|NCT00310778|"     The impact of sodium intake on plasma drug concentrations has previously been reported in the     literature for verapamil and quinidine but, to the investigators' knowledge, never with     renin-angiotensin system blockers such as AT1R antagonists and angiotensin converting enzyme     inhibitors.   "
188486|NCT00310791|"     This study seeks to gain new information on why young women with anorexia nervosa are     predisposed to early bone loss and osteoporosis. Through a randomized treatment trial in     which participants will receive either combined therapy with the adrenal hormone,     dehydroepiandrosterone (DHEA) and estrogen replacement therapy or placebo, we will determine     the effects of an 18-month treatment course on bone mass, circulating markers of bone     turnover, and serum levels of a factor, insulin-like growth factor I (IGF-I). We are also     studying if these therapies change bone structure to increase skeletal strength compared to     placebo, as assessed through cross-sectional geometric analysis of our bone density data by     dual-energy x-ray absorptiometry (DXA).   "
188489|NCT00310830|"     The study will assess the effect of bosentan on pulmonary vascular resistance and exercise     capacity in sickle cell disease (SCD) patients diagnosed with pulmonary arterial     hypertension. It consists of 3 phases: Screening, Treatment and Follow-up. During the     Screening visit, the study doctor will decide if patients meet the study requirements. All     potential patients will have a diagnosis of increased pulmonary artery pressures that is     shown by right heart catheterization conducted shortly prior to start of study treatment.     Patients will be asked to perform exercise capacity test (walking as far as possible for 6     minutes). Following the Baseline visit, the treatment phase consists of 4 additional clinic     visits during which the good and bad effects of the drug are reviewed and exercise capacity     test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected     every month, or more often, if needed. At the end of the study, patients will be asked to     repeat the right heart catheterization and exercise capacity test. After completion of the     study, patients will have the option of enrolling in a long-term follow-up study where all     patients will receive active drug. Patients electing not to participate in the extension     study will be followed up for safety assessments for about 28 days after the end of the study     treatment.   "
188490|NCT00310843|"     Attempt to identify genetic polymorphisms in interrogated pathways which may be associated     with symptomatic hepatotoxicity or severe cutaneous toxicity observed in case patients within     the first 8 weeks of nevirapine therapy.   "
188491|NCT00310856|"     To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate     vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.   "
188492|NCT00310869|"     This research study is a long-term follow-up to an earlier study of developmental care. For     that study, high risk preterm newborns were randomly assigned to a standard care group, which     received the standard care offered in the Newborn Intensive Care Unit (NICU) at the time, or     to an experimental group, which received regular behavioral observations to determine if     changes in their environment or care were needed. The purpose of the current study is to     assess the functioning of these infants again, now that they are adolescents and to compare     the groups to determine if the developmental care used in the original study is effective     long-term.   "
188493|NCT00310882|"     The endogenous digitalis-like compounds (DLC)are steroid hormones synthesized and released     from the adrenal gland.They are integrated in the feed-back system of the     Hypothalami-Pituitary-Adrenal gland axis.One of their remarkable function is to induce     apoptosis in malignant cells. Recently, accumulating data point to the possibility of using     synthetic DLC as new anti-cancer drugs. Less is known about the endogenous metabolism of     these compounds in cancer patients.      Proceeding from preliminary clinical data which demonstrated significantly reduced DLC plasma     levels in breast cancer patients and from in vitro data which showed an impaired release of     DLC towards stress stimuli in athymic nude mice,we put up the hypothesis that a latent     adrenal insufficiency with low DLC levels facilitates the induction and progression of tumor     diseases.   "
188494|NCT00310895|"     The purpose of this study is to determine the safety and the maximum tolerated dose of     GRN163L administration in treating patients with refractory or relapsed solid tumor     malignancies.   "
188495|NCT00310908|"     The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a     non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute     renal colic.   "
188496|NCT00310921|"     The purpose of this study is to determine whether misoprostol administered prior to elective     first trimester pregnancy has an effect on pain and ease of procedure and complications.   "
188497|NCT00310934|"     The objective of this study is to compare optimally given methadone maintenance treatment     (MMT) for heroin dependence with a novel, sequential strategy, where patients are offered     buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to     methadone if the maximal dose of buprenorphine is insufficient.   "
188498|NCT00310947|"     Complete normalization of CFR following AVR for aortic stenosis was observed only for     stentless valves. Besides the superior hemodynamic performance this might explain the     excellent long term results of this valve design.   "
188499|NCT00318786|"     This trial is conducted in Japan. This a clinical trial to study the efficacy and safety of     three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2     diabetes.   "
188500|NCT00318799|"     The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic     parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover     design.   "
188501|NCT00318812|"     The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as     intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with     chronic kidney disease.   "
188502|NCT00318825|"     The purpose of the study is to determine the analgetic effect of nitrous oxide during     colonoscopy, compared to no sedation and intravenous (IV) sedation.   "
188503|NCT00318838|"     This study will assess the effect of multiple dosing of 125 mg azimilide on glomerular     filtration rate (GFR) and total creatinine clearance (GFR + active secretion) in healthy     subjects. Also, it will assess the effect of multiple dosing of 125 mg azimilide on renal     hemodynamics (RPF) in healthy subjects.   "
188504|NCT00318851|"     The purpose of this study is to evaluate ischemic events and neuropsychological changes after     carotid artery angioplasty and stenting with a neuroprotection device.   "
188520|NCT00319072|"     The purpose of this study is to evaluate a prototype web-based module for patients to     generate appropriate and focused health information along with a customized set of questions     to take to their health care provider for discussion on hormone replacement therapy.   "
188531|NCT00319215|"     The primary purpose of this study is to investigate the effects of bedtime administration of     a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road     driving performance. In addition, the drugs' effects on balance are evaluated during the     night, and the next morning residual effects on memory and psychomotor performance.   "
188532|NCT00319228|"     To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in     the treatment of subjects with congenital AT-III deficiency.   "
188533|NCT00319241|"     This study is a randomized trial of interventions to improve parent-child relationships of     drug-dependent mothers.   "
188505|NCT00318864|"     The purpose of this study is to determine if improvements in mood will ameliorate autonomic     dysregulation, HPA dysfunction and typical (e.g. lipids) and atypical risk factors in     depressed patients with elevated cardiovascular risk (CVD). Up to 70, depressed participants     with elevated cardiovascular risk factors were randomized to a cognitive behavioral     intervention (CBT) or a waiting list control (WLC) condition. Twenty non-depressed age and     risk-matched controls will also recruited. Traditional risk factors (e.g. lipids, blood     pressure, heart rate), atypical risk factors (endothelial function, asymmetric     dimethylarginine, C-reactive protein) will be measured pre and post treatment six months     later Subjects will undergo a psychophysiological stress test while cardiovascular physiology     was measured. Salivary cortisol will be measured during the day and during the psychological     stress test. Depressed subjects will be randomized to a 16 week cognitive behavior therapy     intervention or to a wait-list control. It is hypothesized that reduction in mood will be     associated with reduction in typical and atypical risk factors.   "
188506|NCT00318877|"     The purpose of this study is to learn whether overweight children who participate in an after     school team sports program improve their health as much as overweight children in a more     traditional health education program.   "
188507|NCT00318890|"     This trial seeks to accomplish both local and regional control of head and neck cancer and     reduce systemic metastatic disease. To do this, patients will received chemotherapy followed     by chemotherapy and radiation (given together) with an escalating dose of docetaxel.   "
188508|NCT00318903|"     There is a need for more effective therapy for patients following surgery for esophageal     carcinoma. Docetaxel and Irinotecan, independent of each other, have demonstrated activity in     this disease. There is interest in the combination of these two active agents plus     radiotherapy.   "
188509|NCT00318929|"     There is a bimodal distribution to the new onset seizures with one peak occurring in the very     young and the second peak occurring in persons over age 65 years. The presentation of     seizures in the elderly may vary from that of younger patients and the diagnosis may be     confused with other conditions such as transient ischemic attacks. However, the consequences     of epilepsy in the elderly can be severe leading to impaired cognition, increased falls, and     a decreased quality of life. The treatment of epilepsy may be complicated by pharmacokinetic     and pharmacodynamic changes occurring in the elderly.   "
188510|NCT00318942|"     Background: Two recent systematic reviews of the literature and meta-analyses have suggested     that colloids administration might be deleterious in critically ill patients.      Objective: To compare the effects on hospital mortality of crystalloids and colloids when     given for fluid resuscitation in critically ill patients.      Setting: Adult intensive care units (ICUs) in several European countries.      Study design: A multinational, randomised, controlled trial performed on two parallel groups.      Intervention: Any type of crystalloids (control group) versus any type of colloids (including     albumin).      Patients: All patients above the legal age of consent and hospitalised in an intensive care     unit, who need fluid resuscitation (according to the physician). Pregnant women, moribund     patients, brain dead patients, and patients who have a known allergy to colloids or severe     head injury or major burns (> 20% of body surface) or dehydration will not be included.      Primary endpoint: 28-day mortality.      Hypothesis: Assuming a hospital mortality rate of 20% in the crystalloids group, a 0.05 type     I error, 3010 patients are needed to show a difference between the 2 groups of 5% with a 90%     probability (two-sided test).   "
188511|NCT00318955|"     The purpose of this study is to assess efficacy and safety of dexmedetomidine at the time of     extubation and after extubation, in patients requiring postoperative sedation in the ICU.   "
188512|NCT00318968|"     The primary purpose of the study is to develop, and test, an algorithm for identification of     responders to empirical esomeprazole treatment in general practices.   "
188513|NCT00318981|"     This study involves a 7 week dose-response trial of Concerta™ methylphenidate for mothers of     children with ADHD who have ADHD themselves. The aim of this study is to assess the efficacy     of Concerta™ in improving adult ADHD symptoms and impairments (primary outcome), as well as     observed and reported parenting (secondary outcome). The researchers hypothesize that     Concerta™ will significantly decrease mothers ADHD symptoms and impairment, as well as     improve observed and reported parenting   "
188516|NCT00319020|"     The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability     of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial     hypertension or familial pulmonary arterial hypertension who completed FUTURE 1 study.   "
188517|NCT00319033|"     This study will asses the long term safety and efficacy of oral bosentan to patients     suffering from Interstitial Lung Disease.   "
188518|NCT00319046|"     Although miglustat has been approved as a treatment for mild to moderate type 1 Gaucher     disease in patients who are unsuitable for enzyme replacement therapy (ERT), more data are     required to establish the long term efficacy, safety and tolerability of miglustat in     maintaining diseases stability after a switch from ERT.   "
188519|NCT00319059|"     Previous epidemiological studies have shown that in cardiovascular patients, the 34C>T     variant in the gene encoding for the enzyme Adenosine Mono Phosphate Deaminase (AMPD1) is     associated with prolonged survival.      The 34 C>T variant encodes a severely truncated, metabolically inactive protein. We     hypothesize that during ischemia, in these patients AMP in preferentially converted into     adenosine instead of IMP. Adenosine receptor stimulation, in turn, will increase resistance     to ischemia-reperfusion in the myocardial tissue.      To test this hypothesis, 7 male healthy volunteers heterozygous for the 34C>T variant will be     selected from 100 healthy volunteers, which we have previously genotyped. These subjects will     be compared with 7 matched control subjects. Individual ischemic tolerance will be assessed     in the thenar muscle using 99mTc-Annexin A5 scintigraphy.      Briefly, the circulation of the nondominant forearm will be interrupted for 10 minutes by     inflation of an upperarm cuff to 200mmHg en concomitantly, the subjects will perform     isometric rhythmic handgripping until exhaustion. Immediately upon reperfusion, 400 MBq of     99mTc-Annexin A5 will be administered intravenously. Finally, 1 and 4 hours post-injection,     scintigrapghi imaging of both hand will be performed. Targeting of annexin A5 will be     expressed as percentage difference between the experimental and control hand.   "
188521|NCT00319085|"     Background        -  Recently published studies confirm that preheating of femoral component enhances shear          strength of implant-cement interface. Both Iesaka et al 2003 and Jafri et al 2004 showed          reduction in cement porosity on cement-implant interface with preheated femur          components. We will use the radiostereometry analysis (RSA) to investigate how the          preheating of femur component influence on prosthesis survivorship. There are no          clinical controlled studies performed to the date.      The aim of the study        -  Comparison of the migration rates between preheated and non-preheated femur components,          analyzed with RSA.      Methods        -  Randomization of 80 patients into 2 groups with 40 in each. All patients will undergo          standard hybrid total hip replacement. In group one the femur component (Bi-Metric,          Interlock Biomet) will be preheated to 40 degrees of Celsius before cementation. In          group two: the control group, the femur component will be of room temperature. We will          measure the temperature at cement bone interface during the operation with use of          thermocouple electrodes inserted through separate drill hole in the femur. The          measurements will be recorded every 10 seconds. The patients will follow the standard          postoperative rehabilitation program.        -  The RSA analysis will be performed the first day after the operation and at 3, 12, 24          months postoperatively.        -  The Dual-energy X-ray absorptiometry scanning (DEXA) of the femur will be performed at          the first week after the operation and at 12 and 24 months postoperatively.        -  The patients will be followed both clinically and radiologically at 1 and 2 years after          the operation (Harris Hip Score).        -  The results will be expressed as mean + SD (in mm). ANOVA statistical analysis will be          used to confirm the differences between the groups.   "
188522|NCT00319098|"     Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian     virus. Prevention and control will depend on the rapid production and worldwide distribution     of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and     tested in clinical trials to determine the most optimal formulation and the best vaccination     schedule. This study is designed to test in healthy adults aged above 18 years the     reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1     vaccine formulated from Split Virus.   "
188523|NCT00319111|"     The present trial investigates the long-term safety, tolerability and efficacy of bosentan in     patients with inoperable CTEPH.   "
188524|NCT00319124|"     To identify differences between patients with OA of the hip in an early stage and a healthy     control group.      Hypothesis 1.1 There are significant differences between patients with OA of the hip in an     early stage and a healthy control group in terms of functional capacity, biomechanical /     kinematic variables, muscle strength and range of motion.      Osteoarthritis (OA) is by far the most prevalent joint disorder today. The knee and the hip     are large joints to be targeted and is an important cause of pain and disability. In knee OA,     it is shown that significant risk factors in developing the disease are quadriceps weakness,     joint instability, and changes in joint loading. A few studies on hip OA have shown altered     gait pattern, which affect joint loading, and one study has shown weakness in abductors,     adductors and flexors around the hip. As joint loading and muscle weakness are important     factors in the development in knee OA, it might as well be factors influencing OA in the hip.     The purpose of this case-control studies was to compare hip OA patients to a healthy control     group regarding biomechanical and clinical differences. Patients with hip pain, activity     limitations (Harris Hip Score 60-95 p) and radiographically verified hip OA was included. The     healthy control group will have a Harris Hip Score of 100 p. One hundred and ten patients and     fifty controls will be asked to fill in questionnaires on pain, stiffness and physical     function (WOMAC), quality-of-life (SF-36 v2), self-efficacy (Lorigue), and activity (PASE) in     addition to perform 6-minute walk test, sub-maximal cardiovascular function, strength, and     hip range of motion tests. Additionally, Qualisys Pro reflex 3D motion analysis system will     be used during walking, one-leg standing, and raising from a chair on a sub-group of 40     patients and 20 controls.   "
188525|NCT00319137|"     Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric     oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of     NOS, and therefore NO, may be an effective technique for the treatment of migraine headache.     GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory     activity in migraine through a novel mechanism of action. The intent of this study is to     investigate the safety and efficacy of GW274150 for the acute treatment of migraine headache.   "
188526|NCT00319150|"     A strategy for optimizing erythropoietin therapy in patients with erythropoietin resistance.     A multi-centered, open-label, randomized, controlled trial.   "
188975|NCT00311441|"     The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE     vaccines administered to children.   "
188527|NCT00319163|"     Primary Objective: To determine the bioequivalence between the clinical batch process and the     new processes for manufacturing LNG/EE.      Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in     healthy, cycling women.   "
188528|NCT00319176|"     Venous thromboembolism is a condition that causes formation of blood clots in the body. It     may have life threatening consequences if the leg veins, lungs or the brain blood vessels are     involved. In pregnancy, a woman's baseline risk for forming blood clots is increased.      Women with a known prior blood clot during pregnancy, artificial heart valves or other     genetic conditions are at a very high risk for these complications during their pregnancy. It     has been well established that these women benefit from medical treatment with a blood     thinning medication in their pregnancies to prevent further formation of blood clots. These     medications are called Heparins and are given as shots. Prior studies have suggested that a     type of Heparin called low molecular weight heparin (Enoxaparin=Lovenox®) is well suited     for use in pregnancy as it does not affect the baby and has a very low complication rate.      The standard dose given for treatment of these patients has been established previously.     However, there is a concern that complications may occur if the concentration of this     medication falls below its effective level. It is of particular importance in pregnancy, as     the rate of breakdown of this medication increases in pregnancy and may lead to lowering of     its effective levels.      Our study will evaluate the blood levels of enoxaparin before and after administration of     this medication in pregnant women who are receiving this drug for treatment. This will     determine whether an increase in the dose or an increase in the frequency of dosing might     further improve the standard of care.   "
188529|NCT00319189|"     The objective of the present study is to evaluate both the efficacy and safet of nateglinide     in renal transplanta recipients with posttransplant diabetes mellitus or impaired glucose     tolerance. Primarily will the change in glucose tolerance and acute insuline responce be     addressed.   "
188530|NCT00319202|"     Hypothesis:      The use of candesartan 16-32 mg/d for 6 months improves the carbohydrate metabolism, and     decreases the plasmatic levels of adipocytokines and oxidative stress markers, in non     diabetic, non hypertensive subjects with dysglycemia and abdominal obesity, and these effects     are independent of the changes in arterial blood pressure.      General Objectives:      The objective is to study the impact of the treatment with candesartan in the carbohydrate     metabolism and the plasmatic levels of adipocytokines and oxidative stress markers, in non     diabetic, non hypertensive subjects with dysglycemia and abdominal obesity.      Study Design:      This is a randomized, double blind, cross-over, placebo-controlled, clinical trial to assess     the effects of candesartan (up to 32 mg/d for 6 months), over the carbohydrate metabolism,     plasma levels of adipocytokines and concentrations of oxidative stress markers in non     diabetic, non hypertensive, dysglycemic and obese subjects from Colombia. The total duration     of the study is 36 months.      Population:      One hundred non diabetic, dysglycemic and obese, subjects of both genders, over 18 years old,     will be included. To be included subjects should have blood pressure values under 140/90 mmHg     and should be receiving no antihypertensive medical treatment.      Procedures:      Subjects whom fulfill all selection criteria will be included in a run-in period of 15 days     with placebo and hygiene-dietary measures (MHD) including educational, nutritional and     exercise support. The patients that during this Run in phase have a compliance equal to or     greater than 80% will be randomized to one of the two treatment groups (Group A receiving     candesartan 16/32 mg/d for 6 months and then placebo for 6 months, or Group B receiving     placebo during the first 6 months and then candesartan 16/32 mg/d during the last 6 months)     in a 1:1 proportion by blocks of 4 subjects. Randomization will be performed by the     AstraZeneca clinical department. Both groups will concurrently receive the standard treatment     with MHD. Control visits will be programmed every month. Metabolic parameters, including     C-reactive protein (CRP), interleukin-6 (IL-6), adiponectin, leptin, insulin, malonaldehyde     and 8-isoprostanes, will be evaluated every 6 months (at the beginning and end of each     treatment).      Statistical Analysis:      The analysis strategy will be performed by intention-to-treat. In a descriptive analysis, the     averages and proportions will be obtained with their corresponding 95% confidence intervals     for the clinically relevant variables during the baseline evaluation. In order to evaluate     the differences between the groups, the Student's t test, Mann-Whitney and Fischer's exact     tests will be used according to the nature of the study variables. Multiple lineal regression     will be used with the purpose of comparing the treatment groups from baseline and its changes     up to the 6th month of treatment.      Ethical Aspects:      The study will be conducted according to the Helsinki declaration, the good clinical     practices guidelines and the Colombian legislation. Prior to entering the study, patients     must sign a written informed consent that has been approved by the Institutional Ethics     Committee of Fundación Cardiovascular de Colombia.   "
188534|NCT00319254|"     The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the     treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB,     IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.   "
188535|NCT00319267|"     The aim of the study is to demonstrate that the exposure to bosentan in children with     idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension,     using a pediatric formulation, is similar to that in adults with PAH and to evaluate the     tolerability and safety of a pediatric formulation of bosentan in this patient population.   "
188536|NCT00319280|"     In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high     tibial osteotomy is a good choice of treatment for the young and active patient.      However it leaves an open gap which has to be filled with a bone substitute and requires     stable fixation.      Hitherto the golden standard has been autograft taken from iliac crest but there are     donorsite related problems and limited amount available.      Recently injectable and resorbable calciumphosphate-cements have been introduced and used     with promising results in fractures of the distal radius, calcaneus and lateral tibial     condyle.      These new cements seem to be a good alternative to other bone substitutes providing high     initial strength that might promote early mobilisation; it resorbs and promotes     osteoconduction securing safe healing.      The aim of the present study is to evaluate whether there is any difference in clinical     outcome, correction, stability and healing in open-wedge osteotomies with three different     bone substitutes: Autograft from iliac crest and the injectable calciumphosphate-cement     Calcibon and as control a group with an empty gap.      Osteosynthesis is performed with the Dynafix® system (EBI) The investigation is performed as     a randomised prospective clinical trial including 45 patients with a planned 2 years     follow-up period.      Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and     Lysholm score.      Routine standing x-rays is performed. Stability is assessed with Roentgen     Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional     measuring of eventual loss of correction.      This combined with urine and serum bone-healing markers gives a very precise picture of the     healing in the bone-gap.      To asses the cartilage of the knee MRI is performed and biochemical markers fore Collagen     type II degradation are measured.   "
188537|NCT00319293|"     Insulin resistance is an important feature of the polycystic ovary syndrome,and patiens are     successfully treated with the insulin sensitizing agent metformin. The insulin resistance of     lean patients with the syndrome is debated. In this study, we will study the change in     insulin resistance, metabolic and hormonal factors after 3 months of metformin treatment in     lean PCOS women.   "
188538|NCT00319306|"     The purpose of this study is to determine whether patients with asthma are better able to     manage and control their symptoms by using one inhaler daily that both prevents as well as     treats the symptoms of an asthma exacerbation.   "
188539|NCT00319319|"     The purpose of this study is to determine whether the nicotinic receptor antagonist     mecamylamine hydrochloride (Inversine) can augment SSRI-refractory major depression symptoms,     quality of life and cigarette smoking outcomes. A total of n=60 SSRI-refractory patients who     are on stable doses of an SSRI are being recruited into this 8-week double-blind, randomized,     placebo-controlled trial.   "
188540|NCT00319332|"     This is a multi-center, randomized, study to compare Iodine I 131 Tositumomab therapeutic     regimen to Ibritumomab Tiuxetan therapeutic regimen in the treatment of patients with     relapsed or transformed follicular non-Hodgkin's B-cell lymphoma. A total of 350 patients,     approximately 175 patients per arm, will be enrolled at 30 to 40 sites in the United States.   "
188541|NCT00319345|"     The purpose of this study is to compare the effect of bolus of either sodium-lactate or     mannitol on the evolution of intracranial pressure (ICP) during intracranial hypertensive     episodes (IHE)   "
188569|NCT00319709|"     The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly     patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose     of SR58611A compared to placebo in elderly patients with depression. The secondary objectives     are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability     and quality of life in elderly patients with depression.   "
188542|NCT00319358|"     Chronic pancreatitis is a progressive inflammatory disease of the pancreas that presents with     abdominal pain and in late stages may cause diabetes and malnutrition. The pain may be     incapacitating and may affect patients physically, mentally and socially. Pain due to chronic     pancreatitis is difficult to treat. Oxidative stress and free radical mediated injury has     been shown to cause pancreatic inflammation. It has been shown that patients with chronic     pancreatitis are deficient in micronutrients and natural antioxidants such as b-carotene,     vitamin E and C etc. Studies have suggested that antioxidant supplementation may help to     combat pain in these patients. Antioxidant supplementation may decrease the oxidative stress     and boost the antioxidant status, thereby resulting in pain relief. The investigators have     planned to perform a trial to study the effect of antioxidant supplementation on pain relief     in patients with chronic pancreatitis.   "
188543|NCT00319371|"     We study the skin-temperature (skin temperature measurement on different skin regions) and     circadian rest-activity cycles (wrist activity monitoring) of 40 women in their daily life.      This project will provide further information at which circadian phase vasospasms occur in     daily routine life (one week recordings). Special interest lays on the time before sleep. The     attained results could be used to establish a therapy with few side effects for people with     difficulties initiating sleep because of vasospasm.   "
188544|NCT00319384|"     This trial will look at the effectiveness and patient acceptance of ultrafiltration therapy     in an outpatient setting.      The purpose of this study is to determine if ambulatory patients who suffer from heart     failure and hypervolemia can be safely and effectively treated in an outpatient infusion     clinic. The results from this trial will be useful in planning a larger, randomized trial     comparing usual care and ultrafiltration for this patient population in similar ambulatory     settings.   "
188545|NCT00319397|"     The purpose of this study is to investigate the effects of age, exercise and cardiovascular     disease on blood pressure.   "
188546|NCT00319410|"     This randomized clinical trial compares two methods of diagnostic hysteroscopy: vaginoscopic     hysteroscopy vs. traditional method. Pain intensity was estimated using a visual analogue     scale (VAS), and patient satisfaction was evaluated. These endpoints were compared by     treatment assignment. Vaginoscopic hysteroscopy was associated with significantly lower VAS     scores, indicating reduced experience of pain in this treatment group; however, this was not     associated with improved patient satisfaction.   "
188587|NCT00319943|"     The purpose of this study is to determine the neuropsychological and neurophysiological     impacts of a computer-based training program designed to improve the cognitive performance of     patients with mild cognitive impairment (MCI).   "
188588|NCT00319956|"     The hypothesis of this study is that administration of azithromycin to ventilated premature     infants will decrease the incidence and severity of BPD.      The purpose of this study is to determine if Azithromycin treatment is beneficial for     prevention of bronchopulmonary dysplasia in preterm infants.   "
188547|NCT00319423|"     Aims:        1. Evaluate the effect of an exercise therapy program and patient education, versus patient          education only, on hip function among patients with radiologically verified hip OA        2. To identify biomechanical differences during gait, one-leg standing , and          two-legged-raise analysis in patients with hip OA following either exercise therapy and          patient education program, or a patient education program only.      Main Hypothesis:      Significant improved hip function (WOMAC) will be demonstrated in patients with hip     osteoarthritis (OA) (radiographically verified hip OA) following a patient education program     and a 12 week exercise therapy program, compared to those only going through a patient     education program.      Material and Methods:      110 patients with radiographically verified hip OA will be included in the randomized     controlled trial; they will be randomized into:        1. Patient Education, or        2. Patient Education in addition to a supervised exercise program.      The main outcome is:      The Disease Specific WOMAC-Index.      Secondary outcome measures are:      SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain, muscle strength     tests, gait analysis (biomechanical analysis),6 minutes walking test, Åstrand's bike test,     range of motion.      Status:      The PhD student is accepted at the University of Oslo,and the study has so far included 17     subjects.      The study will be carried out:      NAR-Orthopedic Centre, Ullevaal University Hospital in collaboration with Diakonhjemmet     Hospital and University of Delaware.      The study is included in our research program for active rehabilitation.   "
188548|NCT00319436|"     The primary goal of this Stage I therapy development study will be to manualize and test the     preliminary efficacy of a parenting intervention for drug dependent mothers that aims to     foster their ability to recognize children's emotional needs at different ages and their     capacity to be emotionally available to their children.   "
188549|NCT00319449|"     This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe     10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian     population with primary hypercholesterolemia.   "
188550|NCT00319462|"     Point A, the major critical point for dose specification of intracavitary brachytherapy, is     defined as the crossing of uterine artery and ureter in treatment of cervical cancer.     However, the currently advocated systems use hypothetical point A (HPA) to estimate the     dosimetry of brachytherapy. This study is to localize anatomic point A (APA) of cervical     cancer patients for reference of radiotherapy. We will use laparoscopic clipping technique to     localize APA for cervical cancer patients during pelvic and paraaortic lymph node sampling.     When these patients are receiving brachytherapy, orthogonal radiographs will be obtained     after insertion of tandem and colpostats by using Henschke afterloading applicators.   "
188551|NCT00319475|"     Demonstrate the safety and performance of the Aortic Stapler when used to attach a synthetic     graft to an aorta in AAA and Leriche Syndrome patients   "
188552|NCT00319488|"     This study will determine the effectiveness of initiating a high-dose inhaled corticosteroid     (ICS) or a leukotriene receptor antagonist (LTRA) in addition to an inhaled beta2-agonist     (albuterol) at the onset of respiratory tract illness (RTI)-associated symptoms in increasing     episode-free days among young children with recurrent severe wheezing.   "
188553|NCT00319501|"     To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in     selected patients who require intermittent medical intervention for the control of episodes     of acute repetitive seizures. In addition, to assess the support provided by caregivers who     are not themselves or not under the direct supervision of health care professionals at the     time of administration.   "
188554|NCT00319514|"     To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules     in patients with previously untreated, advanced NSCLC.   "
188595|NCT00320047|"     This study will evaluate the effectiveness of the drug baclofen in reducing binge eating and     associated food cravings in people with bulimia nervosa or binge eating disorder.   "
188555|NCT00319527|"     Kidney transplantation, is the preferred treatment option of end stage renal disease.     Compared to dialysis, patients who receive kidneys have a 70% reduction in death, a     dramatically improved quality of life and cost the health care system considerably less. As a     result, there are over 3000 Canadians on the waiting list for a kidney. In order to meet the     shortage of cadaveric kidneys, the rates of living kidney donation have nearly doubled over     the last 10 years. Yet despite its advantages for the recipient, living kidney donation     remains a complex ethical, moral, and medical issue. The premise for accepting living donors     is that the minimal risk of short and long-term medical harm realized by the donor is     outweighed by the definite advantages to the recipient and potential psychosocial benefits of     the altruistic gift to the donor. The only benefit for the living donor is psychological -     donors experience increased self-esteem, feelings of well-being, and improved health related     quality of life with their altruistic act of assuming medical risk to help another. The     short-term consequences of living donation are well established. On the other hand the     long-term consequences of living kidney donation are far less certain. The main medical     concerns of living kidney donation include an increased risk of hypertension, proteinuria,     and low glomerular filtration rate (GFR- a measure of the filtering capacity of the kidney).     Estimates of these outcomes are variable, inconsistent, and uncertain in the literature. This     study is designed to quantify the long-term medical and psychosocial implications of living     kidney donation.   "
188556|NCT00319540|"     The purpose of the study is to test the efficacy of a psychoeducational group program on     unipolar depression   "
188557|NCT00319553|"     This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and     BOOSTRIX® vaccines among US adolescents.   "
188558|NCT00319566|"     The purpose of the study is to determine whether hormone replacement therapy in post     menopausal women with coronary artery disease prevents future heart attacks or death from     coronary heart disease.   "
188582|NCT00319878|"     Aplastic anemia is a rare autoimmune disorder in which the bone marrow production of blood     cells is greatly decreased or absent. Symptoms include fatigue, weakness, tiny reddish-purple     marks on the skin, abnormal bruising, and bleeding from the gums, nose, or intestine. While     some cases of aplastic anemia are caused by medications, toxic exposures, or inherited genes,     most often the cause remains unknown. The purpose of this study is to determine the safety     and efficacy of combining two drugs, sirolimus and cyclosporine, for treating individuals     with aplastic anemia that has not responded to other treatments.   "
188559|NCT00319579|"     Kidney transplantation, a 'miracle' of modern medicine, is the preferred treatment option for     End Stage Renal Disease compared to dialysis, patients who receive kidneys have a 70%     reduction in risk of death, a dramatically improved quality of life and cost the health care     system considerably less. As a result there are over 3000 Canadians, and 57,000 Americans on     the waiting list for a kidney. To meet the shortage in cadaveric kidneys, rates of living     kidney donation have nearly doubled over the last 10 years, and will continue to rise with     growing demand.      Yet despite its advantages for the recipient, living kidney donation remains a complex     ethical, moral and medical issue. The premise for accepting living donors is that the     minimal risk of short and long-term medical harm realized by the donor is outweighed by the     definite advantages to the recipient and potential psychosocial benefits of the altruistic     gift to the donor. The only benefit for the living donor is psychological - donors experience     increased self-esteem, feelings of well-being and improved health related quality of life     with their altruistic act of assuming medical risk to help another. The short-term     consequences of living donation are well established. On the other hand the long-term     implications of living kidney donation are far less certain. This study will look at the long     term implications of living kidney donation.   "
188560|NCT00319592|"     The purpose of this study is to determine non-inferiority in seroconversion and to compare     the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous     virus strain and several wild types strains after completion of vaccination course.   "
188561|NCT00319605|"     Phase IV, observational, post-authorization, cross sectional, open-label, multicenter study     to evaluate the acceptability of oral solution of levetiracetam in patients with partial     epilepsy as assessed by a questionnaire.   "
188562|NCT00319618|"     The purpose of this study is to determine if combination therapy of weekly Taxotere™ with     Iressa™ will increase the objective responses in measurable leasions in metastatic breast     cancer   "
188563|NCT00319631|"     Understanding the role VEGF plays in ARDS consequently provides an ideal opportunity to     discover new therapies for ARDS.   "
188564|NCT00319644|"     The proposed study will evaluate adult patients admitted to the medical or surgical intensive     care units (ICUs) at San Francisco General Hospital (SFGH). On admission, patients will be     randomized in a 1:1 manner to the mini-bronchoalveolar lavage (BAL) quantitative culture arm     in the setting of suspected ventilator-associated pneumonia (VAP) versus the tracheal     aspirate culture arm, which is the current test available at SFGH.   "
188565|NCT00319657|"     The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone     Marrow Transplantation are enrolling patients into a research study to determine if blood     stem cells injected after kidney transplantation will change the immune system such that     immunosuppressive drugs can be completely withdrawn. Patients must have a healthy, completely     human leukocyte antigen (HLA)-matched brother or sister as the organ and stem cell donor.      One to two months before kidney transplant surgery, blood stem cells will be removed from the     donor and the cells will be frozen. After transplant surgery, the recipient will receive     radiation and anti-T cell antibody treatments for two weeks to prepare for injection of the     stem cells. The stem cells will be injected at the end of the two-week treatment. If the stem     cells persist in the recipient, immunosuppressive drugs will be gradually reduced until they     are withdrawn completely at least six months after transplantation. Patients will be followed     in the Stanford clinics for transplant patients. Patients who live outside of the San     Francisco Bay Area must remain near Stanford for six weeks after transplant surgery.   "
188566|NCT00319670|"     To evaluate patient acceptance of a new MiraLax dose formulation in children currently     treated with polyethylene glycol 3350 powder for treatment of constipation.   "
188567|NCT00319683|"     5-fluorouracil (5-FU), one of the most actively investigated anti-cancer drugs, is rapidly     inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This     study will test the safety and effects of oral ADH300004 14 hours prior to oral 5-FU in     subjects with locally advanced, recurrent, or metastatic hepatocellular carcinoma.   "
188568|NCT00319696|"     The aim of the study is to collect long-term efficacy, tolerability and safety data of     bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).   "
194034|NCT00385658|"     This study will investigate the effects of the combination of fluvastatin and fenofibrate on     dyslipidemia in comparison to the combination of simvastatin and ezetimibe.   "
188570|NCT00319722|"     This study uses EEG to study brain waves at rest and in response to specific auditory and     visual sensory stimuli in autistic children. We hypothesize that, compared to same age peers,     autistics will show abnormalities in their electrophysiologic processing of sounds (tones and     phonemes)and visual stimuli (flashes of light)and that these abnormalities will be able to     separate autistics not only from typical children but also into clinical subgroups with     specific biological/electrophysiological characteristics. We hope to find biological measures     which will prove diagnostic of autism in very young children and which can be used in the     measurement of treatment outcome in future intervention trials.   "
188571|NCT00319735|"     The interaction of epidermal growth factor receptor (EGFR) inhibitory agents such as     cetuximab combined with radiation shows promising results. EGFR inhibitory agents also     enhance radiation-induced apoptosis and inhibit radiation induced damage repair. These     interactions may represent the principle effects that contribute to the synergy between EGFR     and radiation.      This trial will investigate the feasibility and activity of this combination in patients with     surgically resectable disease.   "
188572|NCT00319748|"     The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat     metastatic breast, ovarian, endometrial or cervical cancer not responding to standard     treatment.   "
188583|NCT00319891|"     The primary objective of this study is to evaluate the effects of computer-based training     program (HiFi-AD) on the memory and cognitive abilities of individuals diagnosed with mild     Alzheimer's Disease (AD).   "
188584|NCT00319904|"     We will collect DNA from 500 rigorously diagnosed patients with schizophrenia to allow us in     the future to examine phenotypic subtypes in relation to genetic variants. Phenotypes will     include subgroups based on clinical symptoms, medication response, or other biological     markers including neuroimaging or pharmacologic challenges.   "
188573|NCT00319761|"     Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in     the world. A wealth of literature suggests that vitamin D and its analogs have profound     effects on immune system function and glomerular mesangial cell proliferation. Calcitriol, an     active form of vitamin D, is commonly used for the treatment of secondary hyperparathyroidism     in patients with advanced chronic kidney diseases. Therefore, the investigators plan to     conduct a open-label single-arm study to evaluate the safety and efficacy of calcitriol in     the treatment of IgA nephropathy. Ten patients with biopsy-proven IgA nephropathy and     persistent proteinuria despite conventional therapy will be recruited. They will be treated     with calcitriol for 12 weeks. Proteinuria, renal function, serum and urinary inflammatory     markers will be monitored. This study will explore the potential anti-proteinuric and     anti-inflammatory effects of calcitriol in the treatment of IgA nephropathy, which is a major     cause of dialysis-dependent renal failure.   "
188574|NCT00319774|"     Volume overload contributes significantly to the pathogenesis of hypertension in hemodialysis     patients. The Hemocontrol(HC)system (Gambro), which automatically adjusts ultrafiltration     rate and dialysate conductivity according to blood volume variations during dialysis, has     been suggested to improve hemodynamic tolerance and thus facilitate fluid removal.      This randomized controlled trial was designed to compare the use of HC with standard     hemodialysis to test the hypothesis that the use of the HC system may lower home blood     pressure in comparison with standard hemodialysis as a primary endpoint. Secondary endpoints     are a variation in the percentage of dialysis sessions requiring nurses’ interventions for     intra-dialytic hypotension and a change in the health-related quality of life of HD patients.   "
188575|NCT00319787|"     The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard     treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a     difference in the rate of decrease of prostate specific antigen (PSA) levels.   "
188576|NCT00319800|"     To determine whether in docetaxel pretreated advanced NSCLC patients with favorable clinical     parameter(s) gefitinib can produce different outcomes from patients without favorable     clinical parameter treated with irinotecan.   "
188577|NCT00319813|"     A Cross sectional observational Quality Assurance Project in General Practice to COPD     Diagnosis and Treatment   "
188578|NCT00319826|"     The purpose of this study is to investigate why some people develop life-threatening     infections caused by the bacteria Staphylococcus aureus, while other people do not. It is     possible that the infectious ability of the bacteria can determine whether an infection     develops and its severity. The investigators will look at old blood and nasal specimens     collected from 1000 adults who had S. aureus infections and who were hospitalized at Duke     University Medical Center. Previously collected health information regarding these patients     and the specific bacterial traits in the samples will be studied. Eventually this information     may be used to help treat and prevent S. aureus infection.   "
188579|NCT00319839|"     Primary Objective: To assess the overall response rate (complete and partial response) to     Abraxane in patients with recurrent or metastatic head and neck cancer with the addition of     Cetuximab on disease progression.      Approximately 40,000 new cases of head and neck cancer are diagnosed annually in the United     States (Jemal et al, 2003), and over 30% of these patients are expected to die of their     malignancy. Squamous cell carcinoma accounts for more than 90% of head and neck cancer cases.     Although metastatic disease at the time of diagnosis is rather uncommon, and despite     aggressive use of up-front concurrent radiation and cisplatin-based chemotherapy,     approximately 20% of the patients will develop metastases. Patients with recurrent or     metastatic squamous cell carcinoma of the head and neck (SCCHN) have a poor prognosis      A subsequent randomized study conducted by ECOG (E1393) compared high-dose paclitaxel (200     mg/m2) as a 24-hour infusion plus cisplatin 75 mg/m2 with G-CSF support, to low dose     paclitaxel (135 mg/m2) as a 24-hour infusion, plus cisplatin 75 mg/m2 (Forastiere et al,     2001). Patients with newly diagnosed metastatic or recurrent squamous cell carcinoma of the     head and neck, excluding nasopharyngeal primaries were eligible. No prior treatment for     recurrent/metastatic disease was allowed, but patients could have received chemotherapy as a     part of the initial curative therapy that should have been completed 6 months prior to study.      No statistically significant difference could be demonstrated either in response rates or     survival between the two arms (Murphy et al, 2001). This study, however, indicated that     paclitaxel, a member of the taxane class of anti-tumor agent, is active in head and neck     cancer.      New agents to treat head and neck cancer need to be investigated. Abraxane, an albumin-bound     formulation of paclitaxel has shown significant single-agent activity in breast cancer and in     head and neck cancer. Recently, Abraxane has approved for use in metastatic breast cancer.     Given previous randomized phase III trials indicated single agent chemotherapy fared as well     as combination chemotherapy regimen in terms of overall survival, this novel formulation     should be actively investigated in head and neck cancer.   "
188596|NCT00320060|"     The primary objective of the study is to evaluate the safety and tolerability of Pyridorin     (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic     kidney disease.   "
188597|NCT00320073|"     RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Erlotinib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving vinflunine together with erlotinib or pemetrexed may kill more     tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vinflunine when     given together with erlotinib or pemetrexed in treating patients with unresectable or     metastatic solid tumors.   "
188788|NCT00327912|"     The purpose of this study is to compare the outcome in a broad perspective after laparoscopic     Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of     superobesity (body mass index [BMI] > 50 kg/m2).   "
188580|NCT00319852|"     The present clinical study will assess the immunogenicity and reactogenicity of Sanofi     Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months     of age compared to commercially available vaccines in order to meet the requirements for     registration of the product in South Korea.      Primary objective To demonstrate the non-inferiority in terms of seroprotection rates     (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to     Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus     commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV     (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination.      Secondary objectives        1. Immunogenicity: To assess the non-inferiority in terms of seroprotection rates          (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response          rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine          versus historical reference (Study E2I03294 - France). To assess and describe the          immunogenicity of the study vaccines in both groups.        2. Safety: To assess and describe the safety of the study vaccines after each dose.   "
188581|NCT00319865|"     Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.   "
188589|NCT00319969|"     The purpose of the study is to evaluate the objective tumor response rate of amrubicin or     standard topotecan therapy when administered as second-line therapy to ED-SCLC patients who     have chemotherapy sensitive recurrent or progressive.   "
188590|NCT00319982|"     This is a pilot clinical trial to assess whether the administration of diltiazem may be able     to decrease the development or progression of hypertrophic cardiomyopathy (HCM). Diltiazem is     a commonly used medication for the treatment of high blood pressure and studies on animals     with HCM suggest that diltiazem decreases disease development. This study specifically     targets individuals in the prehypertrophic phase of HCM-- those with documented sarcomere     gene mutations without echocardiographic or EKG evidence of LVH, and therefore without a     clinical diagnosis of HCM.      The hypothesis of this study is that starting diltiazem administration early in life (in the     prehypertrophic phase) will decrease the progression of HCM in individuals with sarcomere     gene mutations. This will be assessed by looking at an improvement in the heart's ability to     relax using echocardiography, as well as exploratory analyses of a broad range of features     reflecting the heart's structure and function.   "
188591|NCT00319995|"     This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study     with a screening period. Subjects will receive one of the following three treatment groups     for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or     placebo. The primary objective of this study is to assess the efficacy of the combination of     loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg     montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in     relieving the symptom of nasal congestion. The safety profile of combined     loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.   "
188592|NCT00320008|"     The purpose of this study is to determine whether intensified multifactorial intervention     comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic     complications compared to standard treatment in patients with type 2 diabetes and     microalbuminuria.   "
188593|NCT00320021|"     The primary objective of the study is to evaluate the safety, tolerability and efficacy of     Pyridorin (pyridoxamine dihydrochloride) up to 250 mg given orally twice daily in patients     with diabetic kidney disease.   "
188594|NCT00320034|"     The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer,     albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol     which are mirror images of each other i.e. R-and S- isomers. The investigational treatments     are R-albuterol and S-albuterol.      R-albuterol ( levalbuterol) has been shown to have a slightly better bronchodilator effect as     compared to the racemic albuterol and is well- tolerated in patients. However it is still not     clear whether the S-isomer has no effect or has a harmful effect on the airways.      The purpose of this study is to compare the effects of the R- and S- isomers on allergen     induced airway inflammation in subjects with mild atopic asthma. This will give us a better     idea as to whether the routine use of levalbuterol is superior to racemic albuterol.   "
188825|NCT00328432|"     To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and     reexcision.   "
188598|NCT00320086|"     The purpose of the study is to learn more about Microalbuminuria in children with and without     diabetes. Albumin is a protein that may be excreted in the urine. In some conditions, like     kidney problems or diabetes, the amount of albumin in the urine increases. The purpose of     this study is to measure concentration of albumin in the urine of diabetic children and     compare to healthy children.   "
188599|NCT00320099|"     This study will compare, in adults with septic shock, the safety and efficacy of a     combination of moderate doses of corticosteroids and intensive insulin therapy to that of     moderate doses of corticosteroids. In addition, this study will compare the efficacy and     safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone   "
188600|NCT00320112|"     VA diabetes patients often have difficulty managing their self-care and accessing     clinic-based services; many also lack social support to help them meet the demands of their     illness. Enhanced support is especially important when undertaking and sustaining new     challenging self-care tasks, such as initiating or intensifying insulin treatment regimens.     Although some VAs have implemented telephone nurse care management programs supported by     automated calling services, many are reluctant to adopt these models due to nursing     shortages.   "
188601|NCT00320125|"     The purpose of the study is to evaluate the effects of different dietary calcium have on the     pregnant teen mother and her newborn. We hypothesize that the higher calcium intake during     pregnancy will result in higher bone mass in the newborn.   "
188602|NCT00320138|"     The purpose of this study is to determine the effectiveness of acupuncture as a treatment for     Posttraumatic Stress Disorder (PTSD) among military personnel.   "
188603|NCT00320151|"     This protocol is designed to gather a small amount of blood from patients seen in the New     York Presbyterian Hospital-Weill Cornell Medical Center Pulmonary, Critical Care unit, and 5     West floor (Pulmonary Floor) for clinical care associated with chronic lung disease. This     protocol will also survey medical records of patients with chronic lung disease, in order to     study the clinical characteristics of these individuals. Investigators aim to understand the     genetics of chronic lung diseases, and will use the serum and DNA from this blood to perform     various genotyping studies such as such as genomic/gene expression studies of individuals     with chronic lung diseases   "
188604|NCT00320164|"     This protocol aims to collect human peripheral blood mononuclear cells for the production of     dendritic cells (DC). There are two ways to collect human peripheral blood mononuclear cells     in this protocol. One is by using the method of leukapheresis from normal healthy adults. The     other is by drawing the blood from normal healthy adults and then getting the buffy coats     from the blood.   "
188618|NCT00320346|"     The World Health Organisation has warned that an influenza pandemic is inevitable. The avian     influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic.     This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in     healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza     Vaccine.   "
188619|NCT00320359|"     Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st     line Small Cell Lung Cancer   "
188605|NCT00320177|"     This study will explore the eating habits of children and determine if eating behavior is     linked to genetics.      Children between 8 and 17 years of age may be eligible for this study. It will include     children who have experienced loss of control over eating, children who report overeating     without loss of control, and children who report experiencing neither of the above.     Candidates will be screened with the following:        -  Medical history and brief physical examination, including height, weight, and body fat          measurements. Body fat is measured using a device called a Bod Pod. The child sits          inside the device for about 5 minutes and the machine determines body fat by measuring          air movement. The child must wear a tight-fitting swimsuit for this test.        -  Urine test to look for sugar or protein in the urine and to test for pregnancy in          females.        -  Blood tests for routine chemistries and for gene studies related to eating behaviors.        -  Questionnaires and interviews about the child's general health and eating habits.        -  Acclimatization to test meal conditions for the study. The child is given a yogurt shake          to drink and fills out rating scales before and after the drink.      Participants will come to the Clinical Center two times at 8:30 a.m. for laboratory meal     testing. At each visit, the child will do the following:        -  In the morning, eat a breakfast of apple juice and a buttered English muffin.        -  Between 10 a.m. and 2 p.m., pursue activities at the Clinical Center recreation facility          or the NIH classroom, but may not eat or drink anything that contains calories.        -  At 2 p.m., fill out rating scales about his or her hunger level.        -  At 2:30 p.m., eat from a food buffet that will be made available.        -  After eating, repeat rating scales about hunger level.      The procedure for both visits will be the same, except at one visit the child will be     instructed to eat as much as you would eat at a normal meal, and at the other visit, the     instruction will be to let yourself go and eat as much as you want.   "
188606|NCT00320190|"     The purpose of this study is to compare the efficacy of dasatinib with that of high-dose     (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved     only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. The     safety of these treatments will also be evaluated.   "
188607|NCT00320203|"     The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a     single administration of Anecortave Acetate Depot for treatment of elevated intraocular     pressure (IOP) in patients with open-angle glaucoma.   "
188608|NCT00320216|"     The purpose of this study is to evaluate the efficacy and safety of initial single and     multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to     severe plaque psoriasis.   "
188609|NCT00320229|"     The aim of our study was to demonstrate that, during a percutaneous coronary intervention,     even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid     thrombus resolution and clinical improvement without concomitant differences in hemorrhagic     complications   "
188610|NCT00320242|"     The purpose of this study is to gather data to see if the Laser Cane and/or U-Step Walker     with laser accessory is more effective in aiding with gait freezing than a regular     cane/U-Step Walker in patients who have idiopathic Parkinson's disease.   "
188611|NCT00320255|"     The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as     anticoagulant therapy, when administered to patients with advanced or metastatic cancer and     at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk     profile could lead to significant reduction in this serious and sometimes fatal complication     of ongoing cancer and its treatment.   "
188612|NCT00320268|"     This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and     safe in the treatment of patients with MDD.   "
188631|NCT00320515|"     This is a multicenter, single arm, open-label Phase 1/2 study of pemetrexed plus cisplatin     for patients with unresectable, advanced gastric cancer who had no prior palliative     chemotherapy. Phase 1 was designed to determine the optimal dose of pemetrexed for its phase     2, which has been completed and now a total of 60 qualified patients will be enrolled in the     phase 2 of this study. The treating physician will determined the maximum number of cycles of     pemetrexed plus cisplatin that a patient may receive in this study.   "
188655|NCT00320840|"     To evaluate the contribution of internal and familial resources on the development of     motherhood in a population of mothers having preterm twin infants and comparing this     population to a population of mothers giving birth to single (or twins) full term infants.   "
188613|NCT00320281|"     As clinicians, it is often a struggle to find effective pain control for a certain subgroup     of patients with tetraplegia. These patients often have severe upper back, neck, and shoulder     pain, limiting rehabilitation productivity and potential, and always limiting quality of     life.      This pain appears to be primarily musculoskeletal. Muscles in the upper back and neck become     shortened, rock hard, and extremely tender with even the slightest touch or stretch.     Refractory to multiple classes of medications, modalities, and other treatments, patients     truly suffer-not only from pain, but from fatigue, sedation, expense, and loss of useful     rehabilitation time due to attempted remedies. Unfortunately, this subgroup of patients is     not small and the problem is significant, as anyone who specializes in the treatment of     spinal cord injury patients will recognize.      In search for another form of treatment, botulinum toxin A (BTXA) may be promising for pain     control in that group of patients with tetraplegia whose pain has proven to be refractory to     treatment. It did not take long searching the literature to find compelling evidence that     BTXA may have another mechanism of action for direct pain control, apart from its well known     mechanism for spasticity control. Clinically, it is increasingly being recommended and used     for this purpose. In fact, one of the specific indications now recognized by most for BTXA     treatment is for myogenic pain due to short, tight, strained muscles-just as we see with our     population. Yet, it's application has not been studied in people with tetraplegia. Thus, the     genesis of the project and the hope to help our patients evolved.      Study hypotheses:        -  In addition to traditional treatments used for pain control, injection of BTXA into          cervical and upper back muscles will effectively reduce cervical/shoulder pain severity          reported by individuals with cervical spinal cord injuries, regardless of the etiology          of pain.        -  Pain reduction secondary to the use of BTXA will be associated with a decrease in total          analgesic medication use among SCI patients during acute inpatient rehabilitation.        -  BTXA to treat cervical/shoulder pain will increase active participation in the          rehabilitation program for individuals with tetraplegia during inpatient rehabilitation.   "
188614|NCT00320294|"     To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin     (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.   "
188615|NCT00320307|"     The purpose of the study is to look at the levels of the drug abacavir (ABC) in blood. Also,     the study will look at the levels of carbovir triphosphate (CBV-TP), which is the active     substance produced from ABC in the bodyâ s cells which helps prevent HIV from multiplying.     CBV-TP will be measured in specific blood cells. The amount of ABC and CBV-TP will be looked     at when subjects receive ABC as a 300mg dose twice a day and compared with the levels when     they receive ABC as a 600mg dose once a day.   "
188616|NCT00320320|"     The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI     discontinuation after initial 8 cycles and reintroduction after progression.   "
188617|NCT00320333|"     Pulmonary rehabilitation of COPD patients are implemented in a non-randomized manner in two     settings: primary and secondary health care. The effect on quality of life and     hospitalizations will be evaluated   "
188643|NCT00320684|"     This study will compare the concentrations of serotonin transporter in the brains of women     with a history of anorexia nervosa who are currently maintaining a normal weight to those of     healthy women of normal weight.   "
188620|NCT00320372|"     This registry will collect information about patients with treatment-resistant depression     (TRD) who are currently in a major depressive episode. For the purposes of this study, TRD is     defined as an ongoing depression lasting at least 2 years or that has recurred at least 3     times, to include the current episode, during the patient's lifetime AND has not adequately     responded to 4 or more adequate antidepressive treatments. The registry will follow the     clinical course and outcomes for patients with TRD who are treated with and without     adjunctive (used along with other treatments for depression) vagus nerve stimulation (VNS)     therapy.   "
188621|NCT00320385|"     This study will evaluate and compare the safety and efficacy of lapatinib in combination with     trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast     cancer.   "
188622|NCT00320398|"     This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).   "
188623|NCT00320411|"     This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in     patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2     overexpressing tumors and are refractory to treatment with anthracycline, taxanes and     trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with     the data from EGF100642 and integrated analysis will be carried out in order to enhance the     credibility of the study results.   "
188624|NCT00320424|"     This study is requested by PMDA to confirm the efficacy and the safety for HFS.   "
188625|NCT00320437|"     Our aim is examine avenues by which mothers can transmit their trauma to their children.   "
188626|NCT00320450|"     The purpose of this research is to find out how effective and safe SB-681323 will be in the     treatment of RA when it is added to standard anti-rheumatic treatments.   "
188627|NCT00320463|"     In this study, infants will be randomly allocated into three groups:        -  one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)        -  the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)        -  the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be          double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current          formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV          vaccine.   "
188628|NCT00320476|"     Multiple Myeloma is a incurable disease. Recently developed targeted therapy gave new hope     for the patients with multiple myeloma. Velcade in combination with other agents are     currently in trials for the newly diagnosed patient, we designed sequential treatment with     VTD and MPT for the patients who are not transplant candidates. This would be expected to     result in maximal tumor control, and thus, in maximal survival benefit, equivalent to high     dose therapy with autologous transplantation in younger population   "
188629|NCT00320489|"     To compare the health outcome of patients with schizophrenia, who are at risk for relapse,     when treated with a long acting injection form of olanzapine versus treatment with oral     olanzapine.   "
188630|NCT00320502|"     The purpose of this study is to determine the safety and feasibility of BXT-51072 as a     cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous     intervention (PCI), a procedure to open coronary arteries.      BXT-51072 belongs to a class of drugs called glutathione peroxidase mimics. BXT-51072 works     by imitating a substance produced in various tissues in the body, which prevents damage of     the heart and blood vessels.   "
188632|NCT00320528|"     This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and     emotional well being of children and adolescents with ADHD and to evaluate whether and in     what measure the presence of comorbid conditions (internalizing and externalizing disorders)     influences atomoxetine's ability to improve the quality of life of ADHD subjects.   "
188633|NCT00320541|"     This study will compare the cancer response to both treatments for locally advanced or     metastatic breast cancer   "
188634|NCT00320554|"     The purpose of this study is to determine the motion characteristics of the foot and ankle     with a durometer as a method of measurement.   "
188635|NCT00320567|"     The purpose of this study is to evaluate the effect of norgestimate/ethinyl estradiol on     lumbar spine (L1-L4) and total hip bone mineral density (BMD) in pediatric subjects with     anorexia nervosa.   "
188636|NCT00320580|"     The purpose of this study is to compare the bleeding profile of norelgestromin/ethinyl     estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given     in a traditional cyclic regimen   "
188637|NCT00320593|"     The purpose of the study is to determine if progressive addition lenses (PALs) versus single     vision lenses (SVLs) slow the progression of low myopia in children with poor accommodative     responses (i.e., large accommodative lags) and near esophoria.   "
188638|NCT00320606|"     Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ     transplant recipients to prevent their bodies from rejecting the new organ. Long-term use of     these drugs places transplant recipients at higher risk of serious infections and certain     types of cancer. The purpose of this study is to determine whether immunosuppressive drugs     can be safely withdrawn over a minimum of 9 months from children who received liver     transplants at least 4 years ago.   "
188639|NCT00320619|"     Individuals who undergo spine surgery often have a significant loss of blood and may require     multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may     reduce the amount of blood lost during surgery, which would decrease the number of blood     transfusions required. This study will evaluate the safety and effectiveness of EACA at     reducing blood loss and the need for blood transfusions in individuals undergoing spine     surgery.   "
188640|NCT00320632|"     This study will determine the effectiveness of desipramine in improving cellular signaling,     and thereby decreasing symptoms of depression in people with major depressive disorder (MDD).   "
188641|NCT00320658|"     The purpose of this study is to determine the safety of and immune response to a preventive     malaria vaccine, MSP1 42-C1/Alhydrogel, in healthy adults. This study will also compare     responses to two different doses of the malaria vaccine given with or without the adjuvant     CPG 7909.   "
188642|NCT00320671|"     This 52 week long study evaluates the effectiveness of aripiprazole versus risperidone in     treating people with first-episode schizophrenia. Patients who do not improve with these     medications receive clozapine as their third medication trial.   "
188645|NCT00320710|"     Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1     year with a standard zoledronic acid regimen. Looking at the continued effectiveness and     safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This     study is prospective, double-blind, stratified, multi-center, and two-arm.   "
188646|NCT00320723|"     This proposal seeks to evaluate a pilot smoking cessation treatment program that will combine     nicotine replacement therapy with or without bupropion sustained-release (SR) with cognitive     behavioral therapy for smoking cessation in patients with major mental illness.   "
188647|NCT00320736|"     This study is a double-blind, placebo-controlled trial of the nicotinic receptor agonist,     galantamine, for the improvement of memory and attention in people with schizophrenia and     schizoaffective disorder. Twenty subjects on a stable dose of antipsychotic medications     receive galantamine or identical placebo tablets for 8 weeks. Adverse events are screened for     every week. Tests of memory, attention, and reward responsivity are performed at baseline and     afer 8 weeks on medication. Clinical scales rating psychiatric symptoms are performed at the     beginning, middle, and end of the trial.   "
188648|NCT00320749|"     The primary purpose of this study is to define the maximum tolerated dose of combination     docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects     will be measured in study participants. In addition, researchers will assess data about     preliminary efficacy in patients with this treatment approach.   "
188649|NCT00320762|"     The purpose of this study is to determine whether the OculusGen Collagen Matrix is effective     and safe to implant as an aid of glaucoma and pterygium surgeries.   "
188650|NCT00320775|"     The purpose of this trial is to assess the ocular and systemic safety and tolerability of a     single intravitreal injection of VEGF Trap in patients with subfoveal choroidal     neovascularization (CNV) due to AMD.   "
188651|NCT00320788|"     This study examines the effect of intravitreally administered VEGF Trap in patients with wet     AMD.      The purpose of this trial is to assess the ocular and systemic safety and tolerability of     repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal     neovascularization (CNV) due to AMD.   "
188652|NCT00320801|"     The original objective of this study was to demonstrate the effectiveness and tolerability of     the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the     buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis     pain currently treated with oral opioids. The double-blind treatment intervention duration is     12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen)     will be provided to all subjects in addition to study drug.      This study was terminated early due to administrative reasons with only 20% of the planned     sample size; therefore, the primary objective was changed to focus on the safety evaluation.   "
188653|NCT00320814|"     To assess the ocular and systemic safety and tolerability of a single intravitreal injection     of VEGF Trap in patients with diabetic macular edema.   "
188656|NCT00320853|"     The purpose of the study is to evaluate the change in insulin sensitivity and secretion     indices (early markers for development of diabetes) after 4 weeks of a megadose of Vitamin D.     This will also help to calculate sample size for and choose an appropriate index for a larger     randomized control trial which may be required subsequently.   "
188657|NCT00320866|"     Background: Terminal patients are often unable to swallow and need medications to control     symptoms. In these cases medications are administered continuously and subcutaneously by a     syringe driver. A syringe driver is an expensive and sophisticated equipment to operate.     Hypodermoclysis is a useful and easy alternative used in the homecare setting for hydration.      Objectives:        1. To assess the level of symptoms control by the administration of morphine,          metoclopramide and midazolam by hypodermoclysis versus by a syringe driver.        2. To assess the complications and side effects of infusing these medications continuously          by hypodermoclysis versus by a syringe driver.      Methods: Patients in the homecare setting who meet the criteria for parentral infusion and     suffer: pain, vomit/nausea and/or agitation will be recruited for the study.      A double blind crossover methodology will be used. Each patient will serve as both     intervention and control, and both patient and medical staff will be blinded to the     medication route administration. A research nurse will administer the medications. Crossover     will take place 48 hours thereafter. A research assistant will conduct evaluation of symptoms     and side effects for a period of 4 days. A sample size of 27 patients will be included in the     study (calculated for a significance level of 95% and power of 80%).   "
188658|NCT00320879|"     Aim: To evaluate the renoprotective effect as reflected by short-term changes in albuminuria     of ultra high doses of irbesartan in Type 2 diabetic patients with microalbuminuria Design: A     double-masked randomized cross-over trial including 60 hypertensive Type 2 diabetic patients     with microalbuminuria on ongoing antihypertensive medication. At inclusion, previous     antihypertensive treatment will be discontinued and replaced with bendroflumethiazide 5 mg     o.d. for the entire study. Following two months wash-out (baseline), patients will be treated     randomly with irbesartan 300, 600 and 900 mg o.d., each dose for two months. End-points     evaluated at the end of each study period include urinary albumin excretion rate (UAE, mean     of three 24-hrs collections), 24-hrs blood pressure (ABP); and GFR (51Cr-EDTA).   "
188659|NCT00320892|"     Dying patients are often unable to clear secretions from their large airways, resulting in     noisy breathing usually described as death rattle. While there is no evidence that patients     find this condition disturbing, the noises may be disturbing to the patient's visitors and     caregivers who may fear that the patient is choking to death.      In Israel none of the pharmaceutical drugs listed in the literature exist. Thus, Atropine     drops which have been noted in the literature as being used, though according to our     knowledge no evidence of clinical trials using sublingual Atropine were conducted.      The study is designed as a randomly controlled, double blind crossover trial. The patient     will serve as control for himself, as crossover between placebo and drug (randomly chosen)     will take place. The administrator of the drug will be blinded to the medication, each time     randomly beginning with a different drug (placebo or Atropine).      We will evaluate Atropine Sulphate 1% ophthalmic drops effect on 33 patients using a noise     score scale of 0-3. Noise scores will be taken at the start; 30 min after drug/placebo     administration and every hour thereafter. After 4-hours crossover will take place and     evaluation will follow the same protocol.   "
188660|NCT00320905|"     The proposed study will be the first to examine whether changes in blood flow patterns within     the brain account for the possible cognitive benefits of CR. A clearer understanding of this     possibility may provide key insight into the way CVD affects the brain, help identify     effective treatments, help a greater number of patients return to work, and improve quality     of life.   "
188661|NCT00320918|"     Chart Review on Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM     Cancer Center with a combination of irinotecan, capecitabine and celecoxib.   "
188662|NCT00320931|"     There have been many advances in the test used to look for heart disease. An example of this     newer technology is the Multislice CT scan (MSCT) and Positron Emission Tomography (PET)     scans.      The use of this type of combined scan may show early coronary artery disease or the degree of     damaged heart muscle form a heart attack with a single exam. It may help doctors to know who     might benefit from heart surgery or angioplasty to increase the blood flow to the heart. This     type of detailed images has previously been available only through cardiac catheterization.   "
188663|NCT00320957|"     The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective     and safe to implant as an aid of glaucoma surgery.   "
188664|NCT00320970|"     Diabetic nephropathy is a frequent microvascular complication that occurs in approximately     40% of patients with either type 1 or type 2 diabetes. The most common cause of end-stage     renal disease (ESRD) in the United States and in the developed world is diabetic nephropathy.     Currently, more than half the United States ESRD population has diabetes. More effective     therapies to prevent and treat diabetic nephropathy are urgently needed. One way to increase     therapeutic effectiveness is to refine treatment targets based on improved understanding of     how treatments modulate disease processes. The purpose of this study is to determine whether     a treatment for diabetic nephropathy, the angiotensin receptor blocker candesartan, modifies     mediators of kidney injury independent of blood pressure and the relationships to drug dose.   "
188665|NCT00320983|"     A Phase I Study of Adjuvant Topotecan and Cisplatin with Concurrent Radiation Therapy for     Advanced Cervical Cancer.   "
188666|NCT00320996|"     SGO Society of Gynecologic Oncologists Data Outcomes Project.   "
188667|NCT00321009|"     To prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of     echocardiographic indices of LV mural thrombus. The primary outcome is the presence of LV     mural thrombus at 3.5 months. The secondary outcome is cost analysis comparing the two arms.   "
188668|NCT00321022|"     The primary objective of this study is to determine if emergency department patients with     Transient Ischemic Attack (TIA) that are managed using a TIA accelerated diagnostic     protocol, or ADP, demonstrate a significant decrease in their index visit length of stay     and cost, with comparable diagnostic and 90-day clinical outcomes relative to TIA patients     randomized to traditional inpatient care.      The secondary objectives are to evaluate the potential role of a TIA risk stratification tool     and to determine the time to a diagnostic endpoint in both groups.   "
188670|NCT00321048|"     Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for     breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases     radiation exposure to the heart during radiation for breast cancer. In this trial cardiac     perfusion changes or lack thereof will be quantified in women treated with radiation for     breast cancer while using the ABC device. The control group of the study will consist of     patients randomized to radiation therapy without the ABC device.   "
188671|NCT00321061|"     This study will test whether a vaccination schedule of experimental HIV vaccines is safe and     whether it causes side effects in healthy adult volunteers. It will also compare the effects     of vaccine injected into the muscle (intramuscular), just under the skin (subcutaneous), or     into the skin (intradermal) and will monitor the social impact of being in an HIV vaccine     study.      Healthy volunteers 18-50 years old may be eligible for this 42-week study. Participants are     screened for antibodies to adenovirus, a common virus that causes upper respiratory     infections, such as the common cold. Half of the participants selected will be positive and     half will be negative for antibodies to the virus.      The vaccines used in this study are known as VRC-HIVDNA016-00-VP (called the DNA vaccine)     and VRC-HIVADV014-00-VP (called the rAd5 vaccine). The DNA vaccine codes for four HIV     proteins. The rAd5 vaccine is made using an adenovirus that has been modified to contain DNA     that codes for three HIV proteins. These vaccines cannot cause HIV or adenoviral infections.      Participants are randomly assigned to one of six possible vaccination schedules that include     prime and booster vaccines. The first vaccinations prime the immune system and the immune     response is then boosted later. The groups differ in the type of vaccines given (DNA vaccine     prime with rAd5 booster or rAd5 prime with rAd5 booster), in how the vaccine is administered     (intramuscularly, subcutaneously or intradermally) and in the schedule of administration. All     shots are given in the upper arm. Subjects fill out a diary card at home for 5 days after     each vaccination, recording their temperature and any symptoms. The cards are turned in to     the clinic at the first visit after all 5 days are completed. Subjects return for clinic     visits about 3 days after each prime vaccination and either come in or call the clinic about     7 days after the injection. They call a study nurse 1 or 2 days after the booster     vaccination.      Participants have 15-20 clinic visits during the course of the study, depending on their     vaccination schedule. At each visit, they are checked for health changes or problems, asked     how they are feeling and if they have taken any medications or other treatments, including     over-the-counter medicines, herbal supplements, etc. Blood and urine samples are collected at     some visits. Subjects are tested for HIV several times and asked questions about their sexual     behavior and drug use. Throughout the stu...   "
188672|NCT00321074|"     The purpose of the study is to compare the safety and efficacy of two different tacrolimus     based immunosuppressive regimens, one in combination with daclizumab, the other in     combination with steroids, in recipients of suboptimal livers.      Pharmacokinetics of tacrolimus and bile composition will be measured in a subgroup of     patients.   "
188688|NCT00321282|"     Roughly thirty percent of people that undergo open heart surgery get an abnormal heart beat     afterwards known as atrial fibrillation (AF). While not life threatening, this abnormal heart     beat increases the likelihood of stroke and delays recovery. There are strategies to prevent     post-operative AF, but they are costly and sometimes have undesirable side effects.     Therefore, it would be best if we use these preventive treatments only in high risk patients.      We intend to develop a risk prediction model based on demographic and electrocardiogram (ECG)     findings that will predicted who is likely to get AF. We will develop this model using data     already available on patients who have undergone cardiac surgery. The development of this     model will use the latest mathematical algorithms similar to those used to study genetic     evolution. This type of model is capable of looking at many parameters in an unbiased way, so     that only the strongest, independent predictors remain in the final model. Once, the model is     developed, we will validate the model by comparing our predictions to actual outcomes     previously recorded in the database.   "
188689|NCT00307671|"     The aim of this trial is to lower the morbidity rate in elderly patients affected with     systemic necrotizing vasculitides, by reducing mortality and improving global outcome.   "
188673|NCT00321087|"     This study will evaluate the safety and efficacy of T2000 when used to treat patients with     moderate to severe essential tremor over a 20 week period.      Essential tremor (ET) is a common form of involuntary shaking not related to Parkinson's     disease. The medications that are currently used to treat ET work in a small proportion of     patients and provide only partial improvement in symptoms. Use of these current medications     is also limited by side-effects in many patients.      T2000 is a medication currently under development for the treatment of essential tremor.     Although T2000 is a new medication, it belongs to a class of medications that has been used     for many years for the treatment of a variety of medical conditions. In previous studies,     T2000 appeared to be effective in controlling symptoms of ET and some patients with severe ET     had major improvements in tremor. T2000 was well tolerated for periods up to 20 days and the     minimal side-effects seen were those that would be expected for medications in this class.      The current study will evaluate the safety and efficacy of T2000 in patients with moderate to     severe essential tremor. Patients will receive doses of T2000 beginning at 600 mg a day,     followed by 800 mg a day and up to 1000 mg a day. The total duration of treatment will be 20     weeks. Patient's tremor and neurological examination will be monitored throughout the study.     The response to T2000 will be determined by comparing the severity of tremor while patients     are receiving T2000 compared to the tremor observed without active medication.   "
188674|NCT00321100|"     The purpose of this study is to determine the objective response rate of patients with     previously untreated metastatic colorectal cancer treated with the combination of cetuximab,     capecitabine, and oxaliplatin with out without bevacizumab.   "
188675|NCT00321113|"     The purpose of this study is to explore the safety and efficacy of two different     immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids     versus tacrolimus plus MMF, following induction with daclizumab) in recipients of marginal     donor kidneys.   "
188676|NCT00321126|"     Shigellosis is a major cause of morbidity and mortality in young children in Bangladesh and     other developing countries. Further, the increasing emergence of resistance to a wide range     of antibiotics is of great concern. Another major public health problem in Bangladesh is     malnutrition, which is closely linked with shigellosis and with a high mortality. In     Shigellosis, a heavy nutritional burden is placed on children and vital micronutrients such     as vitamin A is lost in the urine. We recently found that the immune response in S. Flexneri     infection was lower in children who were severely malnourished (weight-for-age≤65% as a     percentage of the National Centre for Health Statistics median) when compared to children     with weight-for-age from >65-75%. T cell responses were primarily affected with lowered     CD4/CD8 ratios, lowered proliferative responses to T cell mitogens, Conconavalin A (ConA) and     phytohaemagglutinin (PHA). However, proliferation of pheripheral blood mononuclear cells     (PBMs) was lowered only in the presence of autologous plasma suggesting that a factor(s) in     plasma, probably nutritional, rather than a defect in cells themselves was responsible. In     children with S. dysenteriae 1 infection, proliferative responses to PHA were similarly     lowered in the presence of autologous plasma but inhibition correlated to lowered     transferring levels in plasma and not to the weight-for-age of the children. Also severely     malnourished children with either S. flexneri or S. dysenteriae 1 infection were more     severely ill. These findingings show that immunity in malnourishrd children with shigella     infection is impaired which may lead to more severe illness. As zinc has profound effects on     immunity as well as clinical outcome in diarrhoeal diseases, it is possible that zinc     deficiency may be a factor in reducing immunity and increasing severity of acute illness in     malnourished children with shigellosis. In this study, we will investigate the effect of zinc     supplementation, in a double blind placebo controlled trial, on inflammatory responses,     outcome of acute illness and growth following recovery from acute illness with S. flexneri     infection.   "
188677|NCT00321139|"     Blockages in the blood vessels of the heart are the main cause of chest pain, heart attacks,     and sudden death. A cardiac catheterization, or injecting x-ray dye into the blood vessels of     the heart and taking pictures, is currently the best way of assessing these blockages. This     procedure, however, does not allow us to know what is happening inside the blockages. Some     blockages have a higher risk of rupturing and completely blocking of the blood vessel while     others are at low risk for doing this.      Blood levels of different substances produced by the body have been shown to be associated     with a higher risk of having chest pain, a heart attack, or sudden death. There is also     evidence from studies in animals and tissues taken from humans during surgery that some of     these substances are made in the blockages themselves.      We would like to investigate whether a number of these substances are made in the blockages     and released into the bloodstream. We will do this by taking one tablespoon samples of blood     upstream and downstream of the blockages in the blood vessels of the heart. The samples will     be obtained by using a very thin catheter, or plastic tubing, that is about 1/3 the size of     the blood vessels of the heart. We will take samples from the tightest blockage found as well     as another, less tight, blockage and compare the two. We will also sample blood from the     tightest blockage after it is opened by doing an angioplasty. Finally, we will also take     pictures of the blockages studied using a very small ultrasound camera inserted into the     blood vessel. We will compare the levels of the substances measured with the features we see     on the pictures.      We hope to learn if some or all of the substances measured can identify which blockages are     more at risk for rupturing and causing heart attacks and sudden death.      All patients who are entered into this study will already be having an angioplasty done. The     procedures needed for the study (sampling of blood and taking pictures with an ultrasound)     are already often, though not always, used in patients undergoing an angioplasty.   "
188679|NCT00321165|"     Total parenteral (intravenous) nutrition in the home setting (Home TPN or HPN) is a life     saving strategy in patients who suffer from severe intestinal failure. Unfortunately, this     treatment modality remains complicated by the development of frequent infectious     complications. This especially relates to the device that is used to establish venous access,     mostly a catheter (Hickman-Broviac type) or a port-a-cath.      Taurolodine is an antimicrobial agent without any known side effects or resistance-related     problems that holds promise as an effective antibiotic lock solution to prevent catheter     infections, as demonstrated recently in a pilot study in HPN patients [Jurewitsch, 2005].      In addition, recently a test has been described which may enable to confirm a suspected     diagnosis of central line infection within one hour, the so-called Acridine Orange Leukocyte     Cytospin test (AOLC) [Bong, 2003]. For this test, blood that is drawn from the central line     is stained with the fluorescent dye acridine orange. Next, microscopic evaluation for the     presence of micro-organisms takes place. Implementation of this test might enable to start     treatment of the infection and prevent unnecessary removal of non-infected central lines     without the necessity to several days wait for culture results.   "
188702|NCT00307840|"     The purpose of this study was to compare two different initial dosing schemes for the     administration of paricalcitol in hemodialysis patients with secondary hyperparathyroidism:     the already in use iPTH/80 scheme, and an iPTH/120 scheme, which corresponds to the     immediately lower dose, based on current instructions on paricalcitol dose adjustment. We     studied the effectiveness of the two dosing schemes in achieving a target iPTH level (150 –     300 pg/mL)   "
188711|NCT00307957|"     The Pillar palatal implant procedure is a minimally invasive and commercially available     treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe.     The implants are placed into the soft area in the roof of the mouth providing support to the     soft palate. This research is being done to compare daytime sleepiness and sleep related     quality of life after palatal implants.   "
188727|NCT00321360|"     Whether patient-maintained sedation (the patient controls his/her degree of sedation using a     hand-held device) using the drug propofol is safer and more effective when using     deteriorating reaction time as an added safeguard against the small potential for over     sedation in a group of healthy volunteers.   "
188680|NCT00321178|"     The standard for treatment Buruli ulcer disease (BUD) used to be surgery but the WHO now     advises streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily)     along with surgery. This preliminary advice was based on observations in 21 patients with     pre-ulcerative lesions of BUD, who were given daily SR treatment for varying periods of time.     In patients treated with SR for at least 4 weeks, M. ulcerans could no longer be cultured     from excised lesions. SR has been introduced without a formal evaluation or comparison with     other treatments have been conducted or published, but the impression is that this treatment     is beneficial and may cure BUD without additional surgical management.      This study protocol evaluated the hypothesis that early, limited lesions of     BUD(pre-ulcerative or ulcerated lesions, ≤ 10 cm maximum diameter), can be healed without     recurrence using antimycobacterial drug therapy, without the need for debridement surgery.      In endemic regions in Ghana, patients will be actively recruited and followed if ≥ 5 years of     age, and with early (i.e., onset < 6 months) BUD.        -  consent by patients and / or care givers / legal representatives        -  clinical evaluation, and by        -  analysis of three 0.3 cm punch biopsies under local anaesthesia.        -  disease confirmation: dry reagent-based polymerase chain reaction (DRB-PCR IS2404)        -  randomization: either SR for 8 weeks, or 4 weeks of SR followed by R and clarithromycin          (C)        -  stratification: ulcerative or pre-ulcerative lesions.      Biopsies processed for histopathology, DRB-PCR-, microscopy, culture, genomic, and     sensitivity tests. Lesions assessed regularly for progression or healing during treatment.     Drug toxicity monitoring included blood cell counts, liver enzymes and renal tests; and ECG     and audiographic tests.      Primary endpoint: healing without recurrence at 12 months follow-up after start of treatment     Secondary endpoint: reduction in lesion surface area and/or clinically assessed improvement     on completion of treatment, averting the need for debridement surgery.      Recurrences biopsied for confirmation, using PCR, histopathology, and culture. Sample size     calculation: 2x74 fully evaluable patients; 80% power to detect a difference of 20 % in     recurrence-free cure 12 months after start of treatment between the two groups (60 versus     80%). A Data Safety and Monitoring Board made interim analysis assessments.   "
188681|NCT00321191|"     This study is investigating the second gas effect, a phenomenon produced by the uptake of     nitrous oxide (N2O) by the lungs, during the course of a typical anaesthetic. The effect is     to increase the concentration of other breathed gases in the lung. These include oxygen and     volatile anaesthetic agents such as sevoflurane, which are also normally administered along     with N2O. We wish to i) measure the magnitude of the second gas effects on both blood and     expired concentrations of sevoflurane (Part 1), and ii) see if a demonstrable difference     exists between the effects on blood and expired concentrations.   "
188682|NCT00321204|"     It is well known that abnormal heart beats from the top parts of the heart, atrial     fibrillation (AF) and atrial flutter (Aflut), occur frequently after most types of cardiac     surgeries. Postoperative AF and Aflut are associated with significant morbidity, longer     hospital stay, and higher related costs. Currently therapies are marginally effective at     preventing this abnormal heart beat. The incidence of abnormal heart beats after cardiac     surgery seems to be a function of the amount of inflammation and oxidative stress induced.     Our group and others have shown that atrial abnormal heart beats are associated with     increased oxidative stress. Thiazolidinediones (TZDs) are medications used to treat diabetes.     Beside their glucose lowering effects, TZDs are shown to exhibit anti-inflammatory and     antioxidant properties. Therefore, we propose to retrospectively analyze the effect of     pre-operative TZDs on the incidence of post-operative AF or Aflut. This study will involve     retrospective chart reviews without further patient contact of all patients having undergone     cardiac surgery in Emory University Hospital, Crawford Long Hospital, or the VA Medical     Center from 2000 to 2005. This study is preparatory to a funding proposal for a prospective     trial.   "
188683|NCT00321217|"     The main aim of this study is to identify genetic markers (at DNA and RNA level) which are     involved in the response to treatment with monoclonal antibodies against TNF in patients with     rheumatoid arthritis.   "
188684|NCT00321230|"     Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.   "
188685|NCT00321243|"     A four-level triage scale (the Geneva Emergency Triage Scale, GETS) has been used since 1997     in our emergency department (ED). A recent evaluation of this scale showed that our     instrument had an excellent intra-rater reliability but insufficient inter-rater reliability.     We also observed a wide variability in the way triage nurses perform (J Clin Epidemiology,     2006 in press). These variations in the triage process are mainly explained by a poor     standardization of vital signs measurement. Therefore, we have recently modified our triage     instrument and introduced explicit criteria for vital signs evaluation during the triage     process.      The objectives of this study are:        -  To evaluate the inter- and intra-rater reliability of our modified triage scale using a          computer simulator        -  To measure the impact of visual clues on the triage decisions when using the triage          simulator        -  To evaluate the performance of triage nurses and chief physicians in their triage          decisions.      We expect to observe:        -  an improvement of the inter-rater reliability of our instrument compared to the previous          version        -  a better standardization and more systematic use of vital signs measurement        -  a higher reliability when visual clues are given to the evaluator        -  lower rates of under- and over-estimation of emergency levels.   "
188686|NCT00321256|"     This research project is supported by a multicentric network of collaborators whose goal is     to assess the efficacy of transplanting allogenic pancreas islets to restore insulin     secretion in patients with brittle type 1, insulin-dependent diabetes mellitus and to improve     their metabolic control.   "
188738|NCT00321503|"     This study is a test of how well a new FDA-approved device is for diagnosing a condition     known as laryngopharyngeal reflux (LPR). The device, which measures pH of the air in the     upper throat, will be compared to several other methods for diagnosing laryngopharyngeal     reflux.   "
188687|NCT00321269|"     Patients with a diagnosis of CHF, NYHA class II, III or IV will be recruited for a study     comparing a nursing intervention addressing CHF (SIM group) or CHF and depression (CIM     group). Participants in the standard illness management program will receive an 8-week,     8-session intervention designed to help them improve daily weighing, salt-restriction,     medication management, etc. This intervention will be conducted in a combination of home     visits and phone visits. They will also receive interactive, telephone-based daily monitoring     that assesses daily weight, dyspnea, fatigue and medication compliance. Patients in the     comorbid illness management program will receive the same illness management program PLUS     education and behavioral techniques designed to help them cope emotionally with the illness.     The comorbid illness management home monitoring will include a twice-monthly screen for     depression. Major Variables: The major outcomes will be depressive symptoms, health-related     quality of life, functional status, heart failure symptom severity, and self-care behaviors     in heart failure.   "
188728|NCT00321373|"     The purpose of this study is to evaluate the immune response and safety of influenza vaccine     candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in     elderly aged 60 years old and above.   "
188690|NCT00307684|"     Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002     (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was     assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a     developmental disorder beginning in childhood and characterized by developmentally     inappropriate inattention, hyperactivity and impulsiveness. Data on the number of adult     patients with ADHD is limited, but it is estimated that approximately 50% of children with     ADHD will have symptoms also in adhulthood. The drug tested in this trial is OROS     methylphenidate. The active ingredient is methylphenidate and the tablet is designed to     release the active ingredient gradually to ensure an effect, which lasts up to 12 hours.     Trial 42603ATT3002 consisted of a 5-week period, where subjects were assigned to either     receive placebo (empty drug) or one out of three different dosages of OROS methylphenidate.     This 5-week period was followed by a 7-week period, where patients received OROS     methylphenidate at their optimal dose. In study 42603ATT3004, subjects who complete     42603ATT3002 are followed for a period of at least 52 weeks to evaluate safety and     tolerability of OROS methylphenidate in patients who are treated with OROS methylphenidate     over a long period of time.      Amendment: At the end of the open-label period of the present study 42603ATT3004, patients     are enrolled into a double-blind placebo-controlled period, which lasts an additional 4     weeks. The purpose of this double-blind placebo-controlled period is to evaluate the     maintenance of effect under continued treatment with OROS methlyphenidate in comparison to     treatment cessation in those patients, who are randomized into the placebo-group.   "
188691|NCT00307697|"     Currently patients thought to have anxiety or depression by their GPs are referred to the     Primary Mental Health Team (PMHEIT) for psychiatric assessment. This assessment consists of a     one-hour interview with a senior psychiatry registrar or psychiatrist, who then writes a     letter to the referring GP. The letter contains diagnostic information and management     recommendations. It is not current practice to send a copy of this letter to the patient. We     hypothesize that patients who receive a copy of the psychiatric assessment letter that is     sent to GPs will improve adherence to treatment recommendations; and that patients who     receive a copy of the letter will have improved outcomes.      GPs will be asked to agree to the participation of their patients. Participants will be     persons over the age of 18 years who are referred to the PMHEIT for assessment and who     receive primary diagnoses of depression or anxiety. After the assessment interview, the     patient will be given an explanatory letter and a consent form. Consenting patients will     complete the Depression and Anxiety Stress Scales (DASS) and a SF12 questionnaire to measure     the level of disability they are experiencing due to their mental condition.      Participants will be randomly allocated into two groups: a control group who will not receive     a copy of the assessment letter, and an experimental group who will be mailed a copy of the     same information that their GP receives. The registrar who conducts the assessment and writes     the report will not know to which group each participant has been assigned. Thus, the content     of the letter will not be affected by knowledge that the patient will or will not see it. The     letter will be sent simultaneously to the referring GP and to experimental group     participants. To ensure confidentiality, the letter will be sent by registered mail.      Three weeks later, participants will be mailed a copy of the DASS. After a week, they will be     contacted by phone and asked for their DASS responses. They will also be asked a brief series     of questions regarding their adherence to the treatment recommendations given in their     assessment letter. When adherence is partial or absent, the interviewer will attempt to     ascertain the reason. This procedure will be repeated at 3 months, except that assessment on     the SF12 will also take place.   "
188692|NCT00307710|"     Primary Objective:      To assess the trend in immunogenic response across patients administered either licensed     trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of     trivalent recombinant baculovirus expressed hemagglutinin vaccines. Immunogenic response is     defined as a 4-fold or greater increase in serum antibody.      Secondary Objective:      To determine the safety and tolerability of 3 doses (15 μg HA per virus, 45 μg HA per virus,     and 135 μg HA per virus) of recombinant baculovirus-expressed HA vaccine in patients with     non-Hodgkin's B-cell lymphoma.   "
188693|NCT00307723|"     The purpose of this study is determine the safety of bevacizumab, oxaliplatin, 5-FU, and     gemcitabine in combination with external beam radiation therapy(Phase I portion) as well as     to begin to collect information about whether this combination treatment is effective in     treating patients with locally advanced pancreatic cancer (Phase II portion).   "
188694|NCT00307736|"     The purpose of this study is determine the safety of 5-fluorouracil, bevacizumab and     erlotinib when administered in combination with external beam radiation therapy(Phase I     portion) as well as to begin to collect information about whether this combination treatment     is effective in treating(Phase II portion) patients with locally advanced rectal cancer.   "
188695|NCT00307749|"     The primary objectives of the study are to evaluate the efficacy and safety of three doses of     MCC-257 in patients with mild to moderate diabetic polyneuropathy   "
188739|NCT00321516|"     The purpose of this clinical research study is to learn if aripiprazole has a drug-drug     interaction with lamotrigine.   "
188696|NCT00307762|"     This is a trial aiming to evaluate the difference of effectiveness between two therapy     methods in patients with acute stroke. The other aim is to use Navigated Brain Stimulation     (NBS)to analyze changes in brain networks during the recovery and as the consequence of     rehabilitation. The groups are:        -  body-weight supported gate trainer rehabilitation        -  gait-oriented traditional physiotherapy Patients in physiotherapy group will have 75 min          physiotherapy daily every workday. This includes 20 minutes walking exercises in the          traditional group while 20 minutes of gait trainer therapy in the gait trainer group.          The evaluation of effectiveness of therapy in each group is made after three weeks'          therapy and at six months. The goal is to have 40 patients until the end of June 2006.   "
188697|NCT00307775|"     This study will address the following questions:        -  Does the use of oestrogen inserted vaginally with an applicator, help with the symptoms          of faecal (bowel) incontinence in women who are past the age of menopause?        -  Do women find it easy to use?        -  Is the treatment safe for the womb lining?        -  Is there any systemic absorption of the treatment?   "
188698|NCT00307788|"     It is our hypothesis that patient's expectations concerning treatment outcome will be     influenced by their psychiatric symptoms, and that this expectancy will have a strong     influence on the efficacy of acupuncture treatment to suppress experimentally induced pain.     We will conduct a study, monitoring expectations but not manipulating them, in a cohort of     patients with chronic low back pain.   "
188699|NCT00307801|"     The purpose of this study is to determine whether the study drug is safe and effective in the     treatment of dysfunctional uterine bleeding.   "
188700|NCT00307814|"     The purpose of this study is to evaluate the effectiveness and safety of less frequent dosing     of PROCRIT (Epoetin alfa) in patients with anemia due to Chronic Kidney Disease (CKD) as     assessed by hemoglobin maintenance, adverse events and health-related quality of life.   "
188701|NCT00307827|"     The purpose of this study is to assess the efficacy, immunogenicity, and safety of various     doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis     (IVSR-UC) and to evaluate optimal dosing.   "
188703|NCT00307853|"     We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean     cumulative morphine consumption following Total Knee or Hip Arthroplasty.      224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the     trial. Patients will be randomized to receive either intraoperative injection and post     operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable     oral placebo tablets. Baseline measurements of relevant outcome measures will taken     preoperatively.      In the recovery room, the patient will begin to receive IV Dipyrone (Optalgin) 1000mg, for a     total of 4 doses during the first 24 hours postoperatively (1000 mg every 6 hours). Once back     in the ward, the patient will be connected to an IV Patient-Controlled Analgesia (PCA)     device, enabling the self-administration of morphine at a set dose of 1mg every 8 minutes,     should the patient require it. The PCA memory registers the time and dose, and the data will     be used later to evaluate post-operative pain.   "
188704|NCT00307866|"     Patients with suspicion of primary or secondary hepatic malignancy in whom a radiological     examination is needed in order to decide on the most appropriate treatment.   "
188705|NCT00307879|"     This trial was performed to evaluate the safety and the efficacy of G-CSF based stem cell     therapy in patients with AMI. MAGIC Cell-1 trial enrolled patients with acute and old     myocardial infarction, and had two groups of cell infusion, and G-CSF alone. MAGIC Cell-2     trial enrolled patients with acute myocardial infarction presented within 12 hours after     onset of chest pain who underwent successful primary PCI. We randomized patients into the     G-CSF group and the control group.   "
188706|NCT00307892|"     The perception of pain is a complex process that is not yet fully understood. With outpatient     knee arthroscopy becoming standard of care, postoperative pain management has become     increasingly important in caring for patients. Traumeel S is a homeopathic complex widely     used in German-speaking Europe for orthopedic pain and inflammation. It contains a mixture of     medicinal plants and minerals, all highly diluted. In some recent studies, Traumeel has shown     anti-inflammatory and analgesic activity.      In this study, the efficacy of Traumeel S will be compared with placebo in reducing pain     during the first 48 hours after arthroscopy. Also compared will be 6 day pain levels,     analgesic consumption, quality of life, post operative knee function, quadriceps atrophy and     safety.      The study design is double blind RCT. 98 patients, aged 18-40 and undergoing arthroscopic     meniscectomy or chondroplasty will be enrolled in the trial. Patients will be randomized to     receive either intraoperative join irrigation with Traumeel S and oral treatment with     Traumeel S, or placebo irrigation and oral ingestion. Patients will continue to take active     or placebo medication for 6 days. Pain will be recorded daily by the patient in the patient     diary using an 11-point numerical rating score (NRS-11. Patients will also record daily     consumption of primary and rescue analgesics. Range of motion (RoM) will be measured on     days 6 and 30 post-operatively, and the Lysholm knee scale and circumference of thigh above     patella will be measured at 30 days. All these measures will be compared with baseline.     Patients will be contacted daily by the research assistant to encourage compliance and to     record their daily NRS and analgesic consumption in the CRF.   "
188740|NCT00321529|"     The purpose of this study is to determine if the ProAdjuster system of analysis can be used     to determine cervical spine instability using the Penning system of radiographic marking as a     standard of comparison.   "
188741|NCT00321542|"     The study aims to examine if non-invasive imaging of the coronary arteries by CT angiography     using an intra-venous injection of X-ray contrast medium in asymptomatic patients with adult     onset diabetes mellitus can predict the risk of developing coronary heart disease.   "
188826|NCT00328445|"     The purpose of this study is to determine the effectiveness of the Positive Action program on     reducing negative behaviors, increasing positive behaviors and improving academic achievement     of elementary school students.   "
188707|NCT00307905|"     We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean     cumulative morphine consumption in patients scheduled for surgical correction of fracture of     neck of hip.      224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the     trial. Patients will be randomized to receive either intraoperative injection and post     operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable     oral placebo tablets. Baseline measurements of relevant outcome measures will taken     preoperatively. Immediately after surgery, patients will receive an initial dose of morphine     of 0.1mg/kg body weight. Patients will take the oral study medication for 21 days. Every four     hours after surgery, patients will be asked to grade their pain on an NRS. Subsequent doses     of morphine will be calculated based upon the patient's weight and current NRS, according to     a preplanned scheme. Patients will be permitted to request additional morphine, beyond their     calculated dose.   "
188708|NCT00307918|"     Glaucoma is the leading cause of irreversible blindness in the world, resulting from     progressive axonal destruction of the optic nerve. Primary open-angle glaucoma is the most     common form, and it is usually painless with insidious onset. Conventional treatment is     focused on lowering intraocular pressure (IOP), the one risk factor that can be modified,     which has been demonstrated to protect against further damage to the optic-nerve head.     Acupuncture is an ancient treatment which has been found to be beneficial for many ailments,     and may reduce IOP. We propose a pilot study to evaluate whether acupuncture is an effective     and safe modality for reducing elevated IOP in patients with open angle glaucoma and primary     ocular hypertension. Patients with elevated IOP on tonometric measurement (20mmHg < IOP <     30mmHg) will be treated twice-weekly with a standardized (as opposed to individualized)     acupuncture treatment. Treatment will last for four-weeks (for a total of 8 treatments), and     patients will be evaluated for IOP diurnal curves at 2 weeks (4 treatment), 4 weeks (end of     treatment ) and then 4 weeks following the last treatment.   "
188709|NCT00307931|"     An open-label multi-center single-cohort study to assess the safety and efficacy of     certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek     patients who have previously responded to infliximab but who no longer have a sustained     response or became intolerant to infliximab   "
188710|NCT00307944|"     The purpose of this study is to determine if using Pantoprazole decreases your daytime     sleepiness and improves your reaction time when compared to using a placebo (sugar pill).   "
188712|NCT00307970|"     To compare lung delivery of fluticasone propionate delivered by HFA-pMDI, using a     conventional polycarbonate of anti-static chamber/mask in a randomized crossover design in     1-6 year old children.      Hypothesis: Anti-static chamber/mask would increase the amount of inhaled corticosteroid     delivered to young children who passively inhale and cannot breath hold.   "
188713|NCT00307983|"     The purpose of this study is to examined the effect of malnutrition and/or inflammation on     atherosclerosis and prognosis in hemodialysis.   "
188714|NCT00307996|"     The purpose of this study is to examine whether CoQ10 administration is effective as an     antioxidant in hemodialysis patients.   "
188715|NCT00308009|"     It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in     women) at the time of prolapse surgery or at a later date. Women with both conditions were     randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or     no leakage when couching was the main end-point, evaluated 1 year after the last surgery   "
188716|NCT00308022|"     This study is designed to exam the effects of early management with high frequency percussive     ventilation (HFPV) on patients with lung injury. Patients at risk for Acute Respiratory     Distress Syndrome (ARDS) will be enrolled and randomized to one of two groups. One group will     be managed with HFPV. The second group will be managed with conventional ventilation     utilizing lung protective techniques. The primary endpoint of the study is rate of ventilator     associated pneumonia. We hypothesized that use of HFPV in patients at risk for the     development of ARDS will decrease the rate of ventilator associated pneumonia when compared     to patients managed with conventional ventilation.   "
188717|NCT00308035|"     People who have had a stroke often have difficulty walking and problems with their balance.     The purpose of this project is to examine problems with foot postures in people who have     weakness on one side of their body   "
188718|NCT00308048|"     Patients with HCV genotype 2 or 3 infection who have a rapid virological response to     treatment are randomised to either 14 or 24 weeks HCV treatment. Our hypothesis is that there     is no important difference in effect between the two treatment effect.   "
188719|NCT00308061|"     This study tested the safety of a new malaria vaccine in adults in Mali, West Africa, and     measured the ability of the vaccine to stimulate antibodies directed against the malaria     protein that the vaccine is based on. Forty adults were randomly assigned to get either the     experimental malaria vaccine or a rabies vaccine, for comparison.   "
188720|NCT00308074|"     The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole     monotherapy in the treatment of children and adolescents suffering from Autism Spectrum     Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in     reducing ASD-associated symptoms of anxiety and aggression, resulting in significant     improvements in global outcome.   "
188721|NCT00308087|"     The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim     will be more effective than rituximab alone.   "
188750|NCT00327418|"     A study to assess the efficacy of once daily atorvastatin 10 mg versus placebo on     cardiovascular endpoints in patients with non-insulin-dependent diabetes mellitus (NIDDM) who     have a history of either hypertension, retinopathy, microalbuminuria, macroalbuminuria, or     who currently smoke, but who do not have established corornary heart disease or other     macrovascular disease.   "
188827|NCT00328458|"     The purpose of this study is to determine the safety of the drug EPO906 that could shrink     tumors when used with radiation therapy in cancer patients.   "
188722|NCT00321295|"     Congestive heart failure (CHF) is a medical condition that is due to left ventricular     systolic dysfunction (LVSD). LVSD is a decreased ability of the heart to pump blood forward.     There are 5 million people in the United States that have CHF and 52,828 new cases are     diagnosed annually. There are 995,000 hospital visits and 52,828 deaths annually due to CHF.     Previous studies have shown that people with this condition are at a higher risk for     complications immediately after any type of heart surgery than are normal individuals. This     includes increased dependence on medications and devices to improve the pumping function of     the heart and blood pressure. Additionally, they also have longer lengths of hospital stay     and higher rates of death compared to normal individuals.      Some patients with LVSD not only have a decreased pumping ability of the heart, they also     have an inefficient pumping function. These patients have been shown to benefit from a device     therapy known as biventricular pacing. Biventricular pacing involves simultaneously     electrically stimulating the two major pumping chambers of the heart known as ventricles     using a pacemaker and wires. This causes a more coordinated contraction of the heart chambers     resulting in improvement in the pumping ability of the heart and blood pressure. Studies have     confirmed that in these patients, implantation of a biventricular pacemaker improves     patients' symptoms and quality of life as well as decreasing a need for future     hospitalizations. Whether biventricular pacing in patients with LVSD improves patient     outcomes after heart surgery has not been investigated.      Some patients temporarily develop slow heart rates after cardiovascular surgery. These slow     heart rates can cause a decrease in the blood pumped from the heart and result in low blood     pressures. Therefore, all patients undergoing cardiovascular surgery, regardless of left     ventricular function, receive temporary pacing wires that are placed on one of the ventricles     during the surgery. Temporary pacing will result in an increase in heart rate and improvement     in the amount of blood pumped by the heart and in blood pressure. The placement of these     wires is precautionary as only a few patients need to be paced for slow heart rates. Once     patients are felt to no longer require them, the wires are easily removed. The purpose of     this study is to determine whether biventricular pacing immediately after heart surgery in     patients with LVSD will improve in-hospital outcomes.      Patients that are scheduled for heart surgery and meet the inclusion criteria will be     approached for consent to participate in this study. Once consented, they will be randomized     to one of three treatment arms: usual care, RV pacing (single ventricle pacing), or     biventricular pacing. Randomization is a process similar to picking numbers out of a hat. The     patients will then undergo surgery as scheduled. During the surgery, the patients will     receive the temporary pacing wires on both ventricles instead of one. Immediately after     surgery, the patients will receive either usual care, RV pacing, or biventricular pacing     depending upon the treatment arm that they were randomized to. The pacing wires will be     removed as soon as the patients become stable as per routine. The clinical, operative, and     in-hospital characteristics of these patients will be recorded on specialized forms. The     characteristics of those that received biventricular pacing will be compared to those that     had RV or no pacing to see whether there was any benefit to this mode of therapy.   "
188723|NCT00321308|"     To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed     for the treatment of patients with locally advanced or metastatic NSCLC who have failed one     prior chemotherapy regimen   "
188724|NCT00321321|"     The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone     GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP     channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the     insulinotropic effect of GIP.   "
188725|NCT00321334|"     The objective of the trial is to determine whether 3 cycles of TP (docetaxel plus cisplatin)     after complete operation will improve survival when compared with 3 cycles of TP prior to     complete resection for NSCLC.   "
188726|NCT00321347|"     Opioid medicines, like morphine, are the main treatment for severe cancer pain.     Unfortunately, some patients suffer severe pain despite high doses of opioids. We hypothesize     that intravenous lidocaine can quickly and effectively treat this kind of opioid-refractory     pain.   "
188945|NCT00311051|"     The purpose of this study is to examine wether the combination of Ramatroban/Montelukast is     as effective as Montelukast alone in patients with mild to moderate atopic asthma (GINA I and     II) sensitive to house dust mite. The test is performed by a specific inhalative provocation.   "
188729|NCT00321386|"     To obtain demographic and baseline ophthalmic parameters (such as Intraocular Pressure     profiles, disc morphological characteristics, central corneal thickness, peripapillary     retinal nerve fibre layer thickness and its serial changes, visual field changes, severity of     any medical associations—e.g. hypertension, migraine, strokes, silent cerebral infarcts) with     non-invasive measurements, in Chinese Patients with Normal Tension Glaucoma   "
188730|NCT00321399|"     Three main clinical outcomes will be assessed:        1. Post-test resource utilization as assessed by referral rate to catheterization within          90-days of the index study;        2. Incremental prognostic value and risk stratification for predicting cardiac death and          myocardial infarction;        3. Cost-effectiveness      To this end, SPARC is organized with two distinct specific objectives with important     differences in patient population and endpoints.      Specific Aim 1: To evaluate the impact of stress perfusion imaging with SPECT or PET, CT     Angiography, and hybrid PET-CT on post-test resource utilization.      The primary endpoint of specific aim 1 is to compare the impact of combined myocardial     perfusion-coronary anatomy data to that of perfusion only [stress SPECT, stress cardiac PET     (without CTA)] and anatomy only (CTA alone) on post-test resource utilization, as measured by     referral to cardiac catheterization within 90 days of index noninvasive testing, in patients     without CAD.      Secondary endpoints:        1. to compare the diagnostic accuracy for detection of epicardial CAD of stress PET and          hybrid PET-CT, stress SPECT, and CTA, as defined by coronary angiography;        2. to compare the referral rate to revascularization within 90 days of cardiac          catheterization.      Specific Aim 2: To compare the incremental prognostic value and risk stratification of stress     perfusion imaging with SPECT or PET, CT coronary angiography, and combined perfusion-anatomy     imaging approaches.      The primary endpoint of specific aim 2 is to compare the incremental value of stress     perfusion only (stress PET and stress SPECT), coronary anatomy only (CTA data), and combined     perfusion-anatomy studies (PET+CTA and SPECT+CTA) over clinical, historical and stress test     data for the prediction of cardiac death and nonfatal myocardial infarction.      Secondary endpoints:        1. to compare the incremental value of these noninvasive imaging approaches over clinical,          historical and stress test data for the prediction of a composite endpoint including          cardiac death, nonfatal myocardial infarction, late (>6 month from index study) referral          to revascularization, or late (>6 month from index study) hospitalization for chest pain          or heart failure;        2. to compare the incremental value of these noninvasive imaging approaches over clinical,          historical and stress test data for the prediction of all cause mortality. In addition,          the ability of these modalities -together and separately- to risk stratify patients is a          primary goal of specific aim 2.   "
188731|NCT00321412|"     The objective of this study is to evaluate the safety and effectiveness of the experimental     drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have     fistulas. The study will test whether or not patients receiving AST-120 experience a greater     reduction in number of draining fistulas and improvement of their other Crohn's disease     symptoms versus patients who receive placebo (material that does not contain any active     medication).   "
188732|NCT00321425|"     In an observer-blinded study ultrasound guidance and electrical nerve stimulation will be     compared for lateral sagital infraclavicular blocks (LSIB). Block effectiveness, time     consumption and patient acceptance will be registered in 80 patients. Ultrasound guidance may     cause less discomfort and could be less time consuming than electrical nerve stimulation.   "
188733|NCT00321438|"     The purpose of this study is to measure viral tropism over time in subjects with X4-tropic or     non-phenotypeable virus while receiving standard of care therapy. This is an observational     study. No investigational treatment will be administered through this study.   "
188734|NCT00321451|"     Fibromyalgia (FM) is a common and chronic disorder characterized by widespread muscle pain,     fatigue, and multiple tender points. The majority of individuals with FM report sleep     problems, including delayed sleep onset, extended awakenings, and non-restorative sleep.     These sleep disturbances may worsen FM-related pain, fatigue, low mood, and low energy. The     purpose of this study is to evaluate the effectiveness of cognitive behavioral insomnia     therapy in reducing sleep disturbances and improving other FM-related symptoms.   "
188735|NCT00321464|"     The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in     the treatment of bone metastases in subjects with advanced breast cancer.   "
188742|NCT00321555|"     Background:        -  About 80% of patients with hairy cell leukemia (HCL) have tumor cells that have a          protein on their surface called CD25.        -  The experimental drug LMB-2 is a recombinant immunotoxin that has been shown to kill          leukemia and lymphoma cells with the CD25 protein. (A recombinant immunotoxin is a          genetically engineered drug that has two parts - a protein that binds or targets a          cancer cell, and a toxin that kills the cancer cell to which it binds.)      Objectives:        -  To evaluate the safety and effectiveness of LMB-2 in patients with HCL whose cancer          cells contain the CD25 protein.        -  To evaluate the effects of LMB-2 on the immune system, determine how the drug is          metabolized by the body and examine its side effects.      Eligibility:      -Adults with hairy cell leukemia whose tumor cells have CD25 on their surface      Design:        -  Up to 27 patients may be included in the study.        -  Patients receive an infusion of LMB-2 through a vein every other day for three doses          (days 1, 3, 5), constituting one treatment cycle.        -  Patients may receive up to six treatment cycles every 4 weeks unless their cancer          worsens or they develop unacceptable side effects.        -  Blood is drawn weekly for various tests.        -  Before each cycle and in follow-up visits, disease status is evaluated with a physical          examination, blood tests, chest x-ray and electrocardiogram.        -  Before the first cycle, patients may have a CT scan, echocardiogram (heart ultrasound          test) and bone marrow biopsy. With the patient's permission, these tests may be repeated          before other cycles also.   "
188743|NCT00321568|"     This study will evaluate the ability of magnetic resonance imaging (MRI) using different     magnet strengths (1.5, 3 and 7 Tesla) to detect damage in different parts of the brain in     patients with multiple sclerosis. The higher the Tesla, the greater the ability to see brain     changes. Healthy subjects will also be studied to compare findings in patients with those of     normal volunteers.      Healthy normal volunteers and patients with multiple sclerosis 18-65 years of age may be     eligible for this study. Patients should have minimal clinical disability. Candidates are     screened with a medical history, physical examination, and blood and urine tests.      Participants undergo three MRI examinations. The first is on a 1.5 Tesla machine. The second     and third - at 3 Tesla and 7 Tesla - are done within 30 days of the first. Each procedure     takes about 2 hours. Before and after the 7 Tesla examination, subjects have an     electrocardiogram (EKG), their blood pressure and temperature are measured and a blood sample     is drawn.      MRI uses a magnetic field and radio waves to produce images of body tissues and organs. This     test has several advantages over x-ray methods, such as the ability to see more clearly     inside the brain and to see chemical changes that might occur in specific neurological     diseases. Also, since x-rays are not used, there is no radiation risk. Radio waves are     generated and changes in magnetic fields are measured and analyzed by computer. For the     procedure, the subject lies on a table that is moved into a metal cylinder (the MRI scanner)     that has a strong magnetic field. Earplugs are worn to muffle loud thumping noises caused by     the electrical switching of the radio frequency circuits. During the MRI, subjects receive an     injection of a contrast agent called Gadolinium, which brightens the images.   "
188744|NCT00321581|"     Background:        -  AZD2171 is an experimental drug that may slow the growth of cancers by blocking          angiogenesis (formation of new blood vessels).        -  Cancer growth is dependent on angiogenesis for nutrition.        -  Inhibiting angiogenesis is a new approach to cancer therapy.      Objectives:        -  To determine the side effects of AZD2171 in children and adolescents with cancer.        -  To determine the highest dose of AZD2171 that can safely be given to children and          adolescents with cancer.        -  To study how the body handles AZD2171.        -  To determine the effects of AZD2171 on various factors related to angiogenesis.        -  To determine if AZD2171 can inhibit cancer growth in children and adolescents.      Eligibility:      -Children and adolescents 2-18 years of age with treatment-resistant solid tumor cancers or     acute myelogenous leukemia.      Design:        -  About 40 patients may be included in the study.        -  AZD2171 is given by mouth in treatment cycles of once a day for 28 days. Treatment may          continue unless the cancer worsens or unacceptable side effects develop.        -  Patients have periodic physical examinations, blood and urine tests and imaging tests          (CT, X-rays, MRI) to evaluate disease throughout the course of treatment. Additional          blood tests are done to study how the body handles AZD2171, to look for proteins that          stimulate angiogenesis, to determine if certain blood vessel cells are affected by          AZD2171, and for other research purposes.        -  Biopsy tissue (when available) is examined for the receptor for new blood vessel          formation.   "
188745|NCT00321594|"     This phase I/II trial is studying the side effects and best dose of belinostat and to see how     well it works in treating patients with liver cancer that cannot be removed by surgery.     Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth   "
188746|NCT00321620|"     The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid     (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer   "
188747|NCT00321633|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. It is not yet known whether carboplatin is more effective than docetaxel in     treating patients with metastatic genetic breast cancer.      PURPOSE: This randomized phase II trial is studying carboplatin to see how well it works     compared to docetaxel in treating women with metastatic genetic breast cancer.   "
188748|NCT00327392|"     Very often patients receive medications before a diagnostic, therapeutic, or surgical     procedure to help them relax, keep them calm, and to relieve them from pain. This is called     procedural sedation. With respect to minimal-to-moderate procedural sedation for minor     surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a     medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified     form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of     propofol, and is being studied to see if it can safely keep patients calm and relaxed during     their medical procedure and then allow for rapid and clear-headed recovery.   "
188749|NCT00327405|"     The use of ocular compression and suture release have helped to improve the safety and     decrease the risks of glaucoma filtering surgery. This study looks at the decrease in     intraocular pressure and glaucoma medications required following glaucoma filtering surgery.   "
188751|NCT00327431|"     Research suggests that blood pressure is influenced by both genetic and environmental     factors. The goal of this study is to find genes that play a role in blood pressure and     understand how they interact with life events (such as job stress) to influence blood     pressure. We hypothesize that the gene for endothelin-1 is associated with increased blood     pressure. Further, we predict that this genetic relationship is moderated by psychosocial     stress factors, specifically job strain and marital cohesion.   "
188752|NCT00327444|"     This study was designed to characterize the effect of aflibercept in participants with     advanced chemoresistant ovarian cancer.      Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap,     ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in     participants with advanced ovarian cancer      Secondary objectives: Safety, tolerability, paracentesis-related parameters,     participant-reported outcome.   "
188753|NCT00327457|"     The investigators aim to use a randomized design to test the effects of 1) tailored physician     recommendations, relative to non-specific recommendations, and 2) coordinated physician     office management systems on patient adherence to colorectal cancer screening     recommendations.   "
188754|NCT00327470|"     The purpose of this study is to determine the benefits of treating subjects with neovascular     age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization     (CNV) as compared to those with established CNV. Additionally, the study would like to     determine the efficacy of Macugen in preserving visual function in those subjects having CNV     secondary to neovascular AMD.   "
188755|NCT00327483|"     Information technology will be brought directly to renal transplant recipients to help them     learn about the large number of medications they are required to take on a life long basis,     in order to prevent errors and improve safety.   "
188764|NCT00327600|"     AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can     be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment     of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is     designed to determine whether the two drugs can be safely combined together, and the Phase 2     part of the study is designed to provide additional safety data and to gain an understanding     of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the     findings from prior clinical studies of DTIC alone.   "
188778|NCT00327782|"     Palliative care in pediatric oncology and neurology is well described in the literature.     There is a lack of information on the care of children terminally ill due to heart failure. A     significant number of children are diagnosed with terminal heart failure for which palliative     care is required.      Objective:      To describe palliative care of children over one year of age with end-stage heart failure,     including need for and types of pain control, hospice use, need for and use of home nursing     and quality of life issues.   "
189019|NCT00312013|"     This study will evaluate the effects of nadroparin on survival and disease progression in     patients with hormone-refractory prostate cancer (HRPC), locally advanced pancreatic cancer     or non-small-cell lung carcinoma (NSCLC).   "
188756|NCT00327496|"     Hepatoma ranks the first on the cancer mortality list in Taiwan, and there are currently no     other effective treatment options for advanced HCC. Therefore, alternative medical     intervention is needed to improve the survival and quality of life of these patients.     Dendritic cells are the most potent type of antigen presenting cells in the human body, and     are involved in the regulation of both innate and adoptive immune responses. If we use     matured antigen presenting cells pulsed in vitro with appropriate tumor associated antigens     under optimal activation conditions. It is anticipated that such treatment might generate or     reactivate a cytotoxic T lymphocyte response against tumor cells and thereby inhibit tumor     growth.      Although there are excited results of tumor vaccine in animal models but successful clinical     tries are rare. There are still some problems needed to be resolved such as immune deficiency     of the cancer patients or the defect of T cell receptors or the problems of tumor escape.     There are complex compositions in tumor cells to be a tumor antigen that will influence the     efficacy of tumor vaccine, so we are going to use tumor lysate to be a tumor antigen.      In this study, the generation of dendritic cells from the patient’s peripheral blood will use     rhGM-CSF and rhIL-4 as stimulating factors, and matured dendritic cells will pulse with tumor     lysate, the ex vivo T cell cytotoxicity for the primary tumor cell will be test. We hope to     cooperate with basic study group in our hospital to do more ex vivo tests and clinical trials     in the future.   "
188757|NCT00327509|"     The aim of the study is to compare messenger ribonucleic acid (mRNA) expression of various     genes in lymphocytes between glaucoma patients and sex and age-matched healthy subjects. A     secondary objective is to analyze the impact of different forms of glaucoma or of a     vasospastic propensity on the findings.   "
188758|NCT00327522|"     The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK     Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .   "
188759|NCT00327535|"     This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia     in patients with non-small cell lung cancer receiving first line myelosuppressive     chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9     micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the     approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg     every week). The anticipated time on study treatment is <3 months and the target sample size     is 100-500 individuals.   "
188760|NCT00327548|"     The purpose of the study is to evaluate the effectiveness of relaxation, with or without     guided imagery, for treating children with functional abdominal pain. The study will evaluate     a child's ability to decrease the amount of pain with these techniques to allow continuation     of normal daily activities at home and at school. The hypothesis is that these relaxation     techniques will help decrease reports of abdominal pain and improve levels of activity.   "
188761|NCT00327561|"     The hypothesis of the existence of a causal association between the systemic     infectious/inflammatory burden represented by periodontitis and endothelial function assessed     by flow mediated dilatation of the brachial artery (FMD) is the subject of the proposed     investigation.      The objective of this randomized controlled clinical trial is to evaluate the effects of     periodontal therapy on endothelial function assessed by Flow mediated dilatation (FMD).      The rationale for this project is twofold:        -  Establish the extent of acute systemic inflammation and endothelial dysfunction          associated with the delivery of subgingival instrumentation for the treatment of chronic          periodontitis        -  Establish whether or not improved control of chronic periodontal infections results in          improved endothelial function and thus the existence of a causal association between          periodontitis and endothelial dysfunction.   "
188771|NCT00327691|"     The primary objective of this study is to determine the degree of additional reduction in     cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently     accepted minimum target level for patients with pre-existing CHD. Secondary objectives     include the safety profile of this treatment strategy, its cost-effectiveness, effect on     other atherosclerotic-related events and procedures, and total mortality.   "
188772|NCT00327704|"     Objective: To determine whether the early administration of albumin as an expander and     antioxidant would improve survival on the 28th day for septic shock patients.      Design: Prospective, multicenter, randomized, controlled versus saline, stratified on     nosocomial infection and center.      Setting: 27 Intensive Care Units (ICU) in France      Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris      Patients: 800 patients could be included during the first 6 hours of their septic shock.   "
188762|NCT00327574|"     Studies have established that high blood pressure (BP) is the most common risk factor for     cardiovascular disease (CVD). Despite a heavy burden of hypertension (33% of all persons aged     45 years and over), there are no reliable data on comparative strategies to manage     hypertension in Pakistan. Our Wellcome Trust funded pilot study in Karachi, Pakistan on 320     adults aged 40 years and over showed that the prevalence of hypertension (95% CI) was 40.3%     (34.9-45.7%), and CVD was 32.5% (27.6-37.8%).      We will now conduct a study with two components: 1) cross sectional study to determine the     prevalence of CVD, and its determinants in Karachi, Pakistan; and 2) prospective, 2x2     factorial design, cluster allocation intervention study to evaluate the impact of a i)     Population approach of household health education (HHE) by community health workers (CHW) on     BP levels of population aged 5 years or over in low-middle income communities of Karachi; and     ii) High-Risk approach of special BP management administered by intensively trained local     general practitioners on BP levels of hypertensive subjects aged > = 40 years from the above     population.      The cost effective BP control strategy would serve as a model for a much-needed national     level hypertension control programme in Pakistan, and possibly other developing countries in     South Asia.      We hypothesize that 1) HHE delivered by trained CHW is superior to no HHE in lowering BP     levels of the population; and 2) management of hypertension by specially trained GPs is     better than usual care provided in the communities of Karachi in lowering blood pressure of     hypertensive subjects.   "
188763|NCT00327587|"     The purpose of this study is to determine the safety and efficacy of the various combinations     of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.   "
188839|NCT00328614|"     The purpose of this study is to determine the safety and effectiveness of Samarium-153 when     given in combination with hormonal and external beam radiation therapy in men with high risk     prostate cancer.   "
188765|NCT00327613|"     Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy     is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the     final end point in blinding diseases of the optic nerve such as glaucoma. It is known that     neuronal cell death in glaucoma occurs by apoptotic mechanism. In earlier studies, the     investigators demonstrated that the process of apoptosis is reflected in circulating     leukocytes by different parameters, like differential messenger ribonucleic acid (mRNA)     expression and an increased fragmentation of the deoxyribonucleic acid (DNA). Such     alterations point out a relationship between cellular stress and apoptotic events.      Based on the results of mRNA-expression, the investigators also expect alterations on the     protein level.      This study is, therefore, designed to characterize the proteome related to the proteins     involved in cell death related pathways.      Thus the expression pattern of several proteins in leukocytes from patients with primary open     angle glaucoma will be analyzed by techniques like Western-blot and tandem mass spectrometry.     These samples will be compared with healthy controls. In addition, they will be also compared     with samples from patients with Parkinson's disease. Since glaucoma is a neurodegenerative     disease, these patients will be included as a positive control in this study.   "
188766|NCT00327626|"     The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of two     ISIS 113715 subcutaneous doses (15 mg and 30 mg/day) in combination with oral antidiabetic     agents (OAD) versus OAD + placebo in patients with inadequately controlled type 2 diabetes,     despite ongoing maximal treatment with OAD.   "
188767|NCT00327639|"     Treatment of patients with beta thalassemia in North America has altered dramatically during     the past 40 years, with improvements in transfusion therapy and introduction of iron     chelation therapy. Thalassemia patients now enjoy an increased life expectancy to the fifth     and sixth decades of life, with fertility and childbearing becoming important issues. Data     regarding this important topic remain limited, without clear data regarding iron control     including serial assessment of hepatic iron concentration, the need for assistance in     becoming pregnant, and use of iron chelating agents during pregnancy. As the life expectancy     increases and overall health improves in thalassemia, clear data on fertility, pregnancy     complications, and the effect of pregnancy on maternal health in thalassemia patients are     necessary since these will have a direct impact on patient care, quality of life, and patient     expectations.   "
188768|NCT00327652|"     This clinical trial evaluated the safety and tolerability of CRS-100, an investigational     agent containing a live-attenuated strain of Listeria monocytogenes (Lm). CRS-100 is     attenuated by genetic modification to limit cell to cell spread and invasion of liver cells.     These attenuations result in decreased virulence of CRS-100 in mice but retain the ability of     the investigational agent to stimulate immunity in test animals and generate anti-tumor     activity in mice. The primary objective of this study was to determine the maximum tolerated     dose (MTD) and to explore the safety profile of a single intravenous dose of CRS-100 in     consenting volunteers. Immunological response to CRS-100 and tumor status of study     participants were also measured. Participation in this first clinical trial with CRS-100 was     restricted to adults with carcinoma refractory to standard treatment (or for whom no standard     treatment is available) and who additionally had liver metastases.   "
188769|NCT00327665|"     As the licensed pneumococcal vaccine is not always satisfactory in elderly, new     investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note:     The study consists of the primary phase (106068): vaccination and follow-up and the extension     (106072) of the primary phase: 1 year follow-up.      This protocol posting details the procedures of both the primary & extension phase.   "
188770|NCT00327678|"     This study is a multicenter trial of treatment for young ALL patients. All ALL patients will     receive the same steroid pre-phase in order to evaluate sensitivity or resistance. Then,     patients will be included into 3 specific trials according to biological features     (immunophenotype, cytogenetics, and molecular biology).      Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL) 2005:        -  T ALL or B ALL non Ph (N=810 patients planned).        -  GRAALL 2005 R: B ALL non Ph CD20+ (N=220 patients planned).        -  GRAAPH 2005: ALL Ph+ (N=270 patients planned)   "
188775|NCT00327743|"     The goal of this phase I-II clinical research study is to find the highest safe dose of     XRP9881 and capecitabine that can be given in combination in the treatment of metastatic     breast cancer in patients who have been previously treated by taxanes and anthracyclines. The     safety and effectiveness of this combination will also be studied. Patients participating in     the study will be asked to give additional blood samples to look at the level of study drugs     in the blood.   "
188776|NCT00327756|"     This study will examine whether mitochondrial function is impaired in patients with bipolar     disorder. Mitrochondria are small organelles inside the cell that are responsible for energy     production. Recent studies in animals and humans suggest that abnormalities of mitrochondria     may be involved in bipolar depression. The study will also examine whether the food     supplement Coenzyme Q10 (CoQ10) improves mitochondrial function and symptoms such as     depressed mood, low energy, anxiety or slowness in thinking and movements in bipolar     patients. CoQ10 has been used to increase cell energy production and as an antioxidant. It     has had some benefit in patients with Parkinson's disease and migraine and in prolonging     survival in patients with cancer and heart failure.      Patients 18-65 years of age with bipolar disorder who are currently in a depressive episode     of at least 4 weeks duration may be eligible for this study. The study has four phases, as     follows:      Phase I: Medication Withdrawal      Patients taper off all psychotropic medications, usually over 1 to 2 weeks.      Phase II: Baseline Evaluation      After being off all medication for about 2 weeks, patients undergo the following procedures:        -  Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). The two          procedures are performed in an MRI scanner. Both tests use a strong magnetic field and          radio waves to obtain images that provide information on brain anatomy and chemistry.        -  Blood tests to assess mitochondrial function isolated from blood cells.        -  Skin biopsy for tests of mitochondria. A small sample of skin tissue 5 x 5 millimeters          is surgically removed.      Phase III: Administration of CoQ10 or Placebo      Participants are randomly assigned to take either CoQ10 or placebo (an inactive look-alike     substance) twice a day by mouth. While taking the study medication, patients have the     following procedures periodically:        -  Rating scales for anxiety and depression and adverse events.        -  Check of vital signs.        -  Blood and urine sample collections.      Phase IV: Study Completion      At the end of the 8 weeks of treatment, patients have a physical examination and     electrocardiogram, and the procedures in phase II are repeated. Participants may then receive     short-term treatment (up to 12 weeks) with medications for bipolar depression, followed by     referred to a community physician for long-term treatment.   "
188777|NCT00327769|"     This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment     compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.   "
188840|NCT00328627|"     The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily     (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.   "
188779|NCT00327795|"     Recently, a paper was published that compared outcomes of patients requiring repair of aortic     coarctation and ventricular septal defect. Some surgeons opt to repair both defects in one     surgery while other surgeons do the repair in two separate operations. Recently at Children's     Healthcare of Atlanta, we have adopted the practice of correcting both defects during the     same operation but through two separate incisions (one on the chest and the other through the     ribs on the side. This reduces the amount of time the patient is on the heart-lung bypass     machine during surgery. This study is a review of patient charts to compare outcomes of     patients who have had surgery to repair their coarctation and VSD during 2002 through 2005.   "
188780|NCT00327808|"     The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic     smoker subjects.   "
188781|NCT00327821|"     The objective is to compare the effectiveness of 4 different commercial weight-loss diets     available to adults in the UK.      This is achieved with a 6 month multi-centre randomised unblinded controlled trial of        -  Dr Atkins' New Diet Revolution,        -  The slimFast Plan,        -  The weight Watchers Pure Points Programme,        -  Rosemary Conley's Eat Yourself Slim Diet & Fitness Plan.        -  No diet (control)      Subjects are a community based sample of 300 (60 per group) otherwise healthy overweight and     obese adults.      Main outcome measures are weight and body fat change over 6 months.   "
188782|NCT00327834|"     The specific aim of this study is to assess the efficacy and safety of atomoxetine compared     with placebo in outpatients with binge eating disorder.   "
188783|NCT00327847|"     The purpose of this study is to determine the average dosage of oral vitamin D     supplementation to maintain optimal vitamin D levels in the body and to see if there are     differences in the response to oral vitamin D supplementation between African-American and     Caucasian subjects.   "
188784|NCT00327860|"     The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute     of Diabetes and Digestive and Kidney Diseases (NIDDK), in collaboration with the Eunice     Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the     National Heart, Lung and Blood Institute (NHLBI) funded a cooperative agreement including two     Clinical Coordinating Centers (at Children's Hospital of Philadelphia and at Children's Mercy     Hospital in Kansas City), a central biochemistry laboratory (at the University of Rochester)     and a Data Coordinating Center (at Johns Hopkins School of Public Health) to conduct a     prospective epidemiological study of children with chronic kidney disease (CKD).   "
188785|NCT00327873|"     The main goal of this study is to establish the effectiveness of palliative oxygen in the     context within which it is usually provided--relief of the sensation of breathlessness and     improvement in quality of life for people with maximally-treated life-limiting illness.   "
188786|NCT00327886|"     The purpose of this retrospective study is to review the postoperative medical management of     infants who underwent bidirectional Glenn operation from January 1, 2003 to December 31, 2005     who were significantly cyanotic.   "
188787|NCT00327899|"     Inotropic therapy is a well-established practice for children with advanced congestive heart     failure (CHF). Inotropes are intravenous medications to help the heart pump stronger and     prolong life while awaiting heart transplantation. Traditionally children have been     maintained on inotropic therapy in the hospital under close, monitored supervision. The     United Network for Organ Sharing (UNOS), which governs organ distribution, has now changed     listing criteria allowing patients awaiting heart transplantation to be discharged to home,     yet maintaining a higher status on the waiting list. In adults, home inotropic therapy has     been shown to be a safe and cost-effective bridge to transplantation. To date, there are no     data on the use of home inotropic therapy in children.      Hypothesis:      We request to do a retrospective chart review of patients receiving this therapy to determine     safety and efficacy of continuous ambulatory home inotropic therapy in children.   "
188789|NCT00327925|"     Blood is collected from patients and cultured in a CimTube (a test tube with stimulation     media) for several days. Following the culture step, the supernatant fluid is tested for the     presence of CAAb on experimental test kits.      Null Hypothesis: There is no relationship between the presence or absence of ovarian cancer     (OC) and the CAAb i.e. d=0.      Alternative Hypothesis: The expectation of the CAAb in the cancer population differs from     that of the control population, i.e. m1 is not equal to m2. Since the sign of the difference     is not important, the test will be two-sided.   "
188790|NCT00327938|"     The purpose of this study is to find out if the tetanic noxious stimuli and the measured skin     conductance response can be used as a test in patients before surgery to have an indication     about what amount of analgesics the patient will need during surgery.   "
188791|NCT00327951|"     Failure to thrive and difficulty gaining weight is a sign of uncompensated congestive heart     failure (CHF). Infants with Trisomy 21 and complete atrioventricular canal defects (CAVC)     frequently develop uncompensated CHF and weight gain failure pre-operatively. A weight of 5     kg has been suggested as optimal for timing of CAVC repair. A delay in surgical repair often     occurs if weight gain stalls and reaches a plateau prior to reaching 5 kg. A retrospective     review performed by Kogon, et al, of children undergoing surgery for VSD at CHOA at Egleston     recently reported that age and weight at surgery may not, however, be associated with adverse     surgical outcome.      The purpose of this study is to determine the optimal timing for surgical correction of CAVC     in Trisomy 21 infants based on reaching a plateau of failed weight gain despite maximal     anti-congestive and nutritional therapy.   "
188792|NCT00327964|"     Malaria remains a disease that causes much death and sickness, especially in sub-Saharan     Africa. An accurate, simple, and inexpensive method of diagnosing malaria is urgently needed.     The purpose of this study is to evaluate a different diagnostic method compared to those most     frequently used. The study may also identify the factors causing false positive and false     negative results using the alternative method. Participants will be 600 Ugandan children aged     1-10 years who are enrolled in protocol 04-068. Those who develop a fever over the 12 month     duration of the study will be tested for malaria by both the standard and the new methods.     These tests will require a few drops of blood to be collected by finger prick. Subjects will     be treated on the basis of standard diagnostic testing (i.e. expert microscopy).   "
189104|NCT00314145|"     The purpose of this study is to determine non-inferiority in seroconversion and to compare     the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous     virus strain after completion of vaccination course.   "
188793|NCT00327977|"     Congenital heart disease is a major cause of morbidity and mortality in infants. Many cardiac     defects require surgical palliation or repair in the newborn period. The effects of chronic     hypoxia on growth and development are unclear. Infants with very severe cardiac defects may     undergo surgery in infancy, but often this cardiac surgery can provide only palliation, not     correction. As a result, these infants are exposed to a physiology of chronic hypoxia during     the neonatal period through infancy, a critical period of growth and development. The optimal     oxygen saturations for infants with palliated cardiac defects is unknown. The purpose of this     study is to analyze the growth and development of infants with post-surgical palliation in     infancy and assess variations in oxygenation saturations and hemodynamics as they relate to     weight gain, linear growth and increases in head circumference during the first three years     of life.   "
188794|NCT00327990|"     This is a two part study (screening and treatment). The first part (screening) is designed to     evaluate the percentage of patients missed in diagnosing osteoporosis by general     practitioners (GP's). The second part (treatment) is designed to determine the preference by     patients for the once monthly ibandronate or the once weekly alendronate.   "
188795|NCT00328016|"     The purpose of this study is to investigate the nature of the physiological reasons for the     decreases in resting blood pressure that can result from systematic practice of     computer-guided breathing exercises or meditative relaxation.   "
188796|NCT00328029|"     Recently, several conditioning regimens did not include total body irradiation (TBI) anymore,     especially in the case of young children due to cognitive sequelae and late effects on growth     and height. Thus, such effective chemotherapy conditioning regimens were developed to avoid     these complications. Busulfan is one of the major drugs used in these treatments, but, is     also administered in high dose chemotherapy followed by autograft. In both situations, long     term pulmonary side effects were diagnosed in a few cases. Even if the occurrence is not very     frequent, the clinical management is a real challenge regarding the reduced quality of life     and life expectancy of these patients. Up to now, no correlation was done between respiratory     sequelae and busulfan pharmacokinetics. Hence, in the investigators' pediatric     onco-hematological unit, a prospective study will begin and last three years to assess the     respiratory side effects due to busulfan and their potential links with individual drug     pharmacokinetic measures. These results will be compared to patients treated with TBI during     the same period of time.   "
188797|NCT00328042|"     The objective of this study is to compare the efficacy of a 6-session hepatitis C     self-management workshop to a hepatitis C self-management self-study program. Both     interventions are designed to help people with hepatitis C learn to actively self-manage     their chronic HCV infection, and ultimately, to improve health outcomes for veterans with HCV     who are not receiving Interferon-based treatment. Participants complete a total of four     assessments. The fourth assessment, a 12-18 month assessment is an approved addition to the     original study design   "
188798|NCT00328055|"     The purpose of this study is to compare the acceptability, usefulness, self-efficacy and     comprehension of an easy-to-read advance directive form versus a standard advance directive     form written at a post graduate reading level.   "
188828|NCT00328471|"     The purpose of this randomized controlled trial (RCT) is to test the effectiveness of a     comprehensive interdisciplinary post-discharge stroke care management intervention in     improving the overall well-being of 190 stroke survivors as compared to 190 patients who     receive usual post-discharge stroke care.   "
188829|NCT00328484|"     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease. Symptoms include     shortness of breath, wheezing, and difficulty exercising. Increasing exercise and physical     activity may relieve the symptoms of COPD and may also slow the progression of the disease.     The purpose of this study is to evaluate the effectiveness of a lifestyle activity program     versus a traditional exercise program at increasing the amount of physical activity among     individuals with COPD.   "
188799|NCT00328068|"     Background:      Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification     and/or diagnosis of spondyloarthritis have limitations when applied to early disease.     Moreover, MRI is not part of any of the established criteria and the precise role of MRI in     early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI)     changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper     patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the     members of the ASAS International Working Group decided to conduct a prospective multi-centre     study to evaluate (validate) the new candidate criteria, and to assess their performance as     diagnostic criteria.      Aims of the study:        1. To evaluate the new candidate criteria for axial SpA in a multi-centre setting.        2. To assess the potential role of the new candidate criteria to be used as diagnostic          criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is          mandatory as are longer periods of follow-up .        3. To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria          against criteria which are tailored to either predominant axial disease or predominant          peripheral disease. To accomplish this, both patients with predominant axial disease          (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis)          will be included.   "
188800|NCT00328081|"     The purpose of this study is to see whether care gap(s) exist in the management of obesity     and its related conditions in obese patients seen by primary care physicians and specialists.     The study will also look at whether there is a compliance and adherence gap that exists in     patients prescribed medication for obesity management.   "
188801|NCT00328094|"     Aggressive intraoperative and postoperative management of blood glucose may substantially     decrease perioperative cardiovascular and infectious complications in diabetic and     non-diabetic patients undergoing vascular surgery.      The purpose of this study is to compare the tight versus traditional blood glucose control in     diabetics and non-diabetics undergoing vascular surgery in regard to their postoperative     fatal and nonfatal cardiac outcomes, and the secondary effects such as rate of infections,     overall morbidity and 30-day mortality.   "
188802|NCT00328107|"     The purpose of this study was to determine the dose-related safety, immunogenicity, and     protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy     adults.   "
188803|NCT00328120|"     The primary objective of this study is to assess the tolerability of 500mg fulvestrant in     postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer   "
188804|NCT00328133|"     Trauma surgeons throughout the US have begun using recombinant activated factor VII (rFVIIa)     to control severe hemorrhage following injury when traditional measures have failed. Despite     promising results from several small studies, there remain several unanswered questions     regarding the use of this relatively expensive product in injured patients including:        -  The timing of administration        -  Selection of appropriate patients who are most likely to benefit        -  The effective dose in injured patients        -  The potential need for repeated dosing        -  The need for administration of platelets and correction of acidosis prior to          administering the first dose        -  The risks associated with the use of rFVIIa including venous and/or arterial thrombosis        -  The potential for rFVIIa to cause or aggravate post-injury organ failure and/or          infectious complications        -  An analysis of cost versus benefit The purpose of this study is to collect a large          sample of patients from multiple institutions in order to address the issues listed          above. To this end, the Western Trauma Association Foundation is sponsoring a          multi-center case registry for patients receiving rFVIIa for treatment of uncontrolled          hemorrhage.   "
188805|NCT00328146|"     Re-operative surgery in children is extremely challenging and injury to the underlying     cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary     bypass is required in an emergency, there are often limited sites for peripheral cannulation.     Injury to the heart can easily result in catastrophic complications and death.   "
188806|NCT00328159|"     Usual dietary therapies of mitochondrial fatty acid oxidation disorders (FAO) are based on 3     strategies:        -  limitation of lipid intake in the diet;        -  supplementation of the diet with medium-chain triglycerides (MCT) for patients affected          with disorders of long-chain FAO;        -  some specific supplementations (for example, L-carnitine).      These strategies are often ineffective. The aim of the present study is to evaluate new     therapeutic ways based on the underlying energetic defect observed in these disorders. The     long-term goal is to develop efficient therapies of these disorders.   "
188807|NCT00328172|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of     treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition,     there will be an open-label treatment arm with metformin for sensitivity measurement with     this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in     this study.   "
188808|NCT00328185|"     Transplantation is the preferred method of treating many forms of end-stage organ failure.     While short-term results have improved, long-term outcomes remain inadequate. Myocardial     fibrosis could potentially have an adverse effect on long-term cardiac function. We wish to     study the degree of fibrosis to see if we can predict survival following pediatric heart     transplantation.   "
188809|NCT00328198|"     This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and     safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for     patients with relapsed or refractory B-CLL who have been previously treated.   "
188830|NCT00328497|"     This single center, open-label study will evaluate the safety and efficacy of Panzem     (2-methoxyestradiol, 2ME2) Nanocrystal Dispersion (NCD) administered orally with recombinant     human monoclonal antibody against vascular endothelial growth factor (bevacizumab)     administered intravenously, in patients with locally advanced or metastatic carcinoid tumors.   "
188831|NCT00328510|"     Fractionated stereotactic radiotherapy (SRT) requires extremely precise and reproducible     immobilization of the patient's head. This randomized study compares the efficacy of two     commonly used forms of immobilization used for SRT.   "
189115|NCT00314288|"     The primary purpose of the study is to investigate the anti-dyskinetic effect of several     doses of sarizotan in Parkinson patients in order to generate information on the     dose-response relationship (dose-finding).   "
188810|NCT00328211|"     The overall goal of this study is to better understand how cholesterol is absorbed and     utilized in the body(metabolism) and how serum cholesterol affects the development of     hardening of the arteries (atherosclerosis). The purpose of aim 1 is to assess the role of     the amount of different bile acids in the intestine and how they affect the absorption,     synthesis and digestion of cholesterol. The effect that these bile acids have on how fast the     gall bladder empties and the release of a hormone in the blood after a meal will also be     studied. The purpose of aim 2 is to assess the role of phospholipid (a fat containing the     element phosphorus) in the intestine and how it affects the absorption, synthesis and     digestion of cholesterol in normal people and in people with a genetic condition (mdr3     deficiency)that affects phospholipid and bile acid metabolism. The purpose of aim 3 is to     assess the role of a material that acts like a detergent called Pluronic F-68 which is known     to block the absorption of cholesterol. The purpose of aim 4 is to determine if the     cholesterol from food and the cholesterol made by the body are digested and absorbed     differently.   "
188811|NCT00328224|"     To evaluate the dental status of children using ritalin and suffering from ADHA in comparison     to healthy children.   "
188812|NCT00328237|"     The purpose of this study is to evaluate the incidence of neutrophil engraftment after     transplantation of one or two cord blood units meeting a predetermined total minimum cell     dose of 2.0 x 10 to the seventh total nucleated cell (TNC)/kg.   "
188813|NCT00328250|"     This study will evaluate the effectiveness of an online cognitive behavioral therapy     intervention in improving sleep, mood, and cognitive functioning in people with insomnia.   "
188814|NCT00328263|"     The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus     placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.   "
188841|NCT00328640|"     Is a secondary prevention intervention, focused on implementation of standardized pre-printed     discharge orders for hospitalists, effective at increasing utilization of the following     evidence-based treatments 6 months after discharge for ischemic stroke:        1. Treatment with statins,        2. Control of hypertension, and        3. Anticoagulation in patients with atrial fibrillation.   "
189105|NCT00314158|"     The purpose of this study is to determine whether a glaucoma therapy is safe and effective in     treating patients with open-angle glaucoma or ocular hypertension.   "
189106|NCT00314171|"     The purpose of this study is to determine whether a glaucoma therapy is safe and effective in     treating patients with open-angle glaucoma or ocular hypertension.   "
188815|NCT00328276|"     The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive     symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system     hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the     pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission has     been considered as a novel treatment approach. To date, there have been several trials on     NMDA enhancers reported. For example, sarcosine (N-methylglycine, a glycine transporter I     inhibitor) showed therapeutic effects not only in chronically stable patients but also in     acutely exacerbated ones when added-on to antipsychotics. In addition, sarcosine yields     excellent safety profiles, in comparison to current antipsychotics.      It remains unclear whether NMDA enhancers, such as sarcosine, can serve as monotherapy for     schizophrenia. The aims of this project are to examine the efficacy and safety of sarcosine     monotherapy for acutely-ill schizophrenic patients, and to compare the effects of 2     grams/day, effective dose, with 1 gram/day, ineffective lower dose.   "
188816|NCT00328289|"     Hypothesis: Intradialytic blood pressure and dialysis efficacy (in terms of urea removal)     improve under electrical muscle stimulation or passive leg movement on a treadmill.   "
188817|NCT00328302|"     The type 1 diabetes patients who were still normoalbuminuric and normotensive, after 17 years     duration and a second research kidney biopsy, could enter the double blind treatment study of     Atacand or Placebo.      The treatment study continues for five years treatment and ends with a third kidney biopsy.      The study hypothesis is that the effect of ARB during 5 years on the histopathology are more     pronounced than the effect on histopathology of placebo.   "
188818|NCT00328315|"     The goal is to conduct a clinical pilot study to evaluate the use of a rotating multi-segment     slant-hole collimator in the detection of myocardial defects.   "
188819|NCT00328341|"     It is anticipated that the use of tissue oxygen monitoring to measure brain tissue oxygen and     deltoid muscle oxygen will provide more precise information about focal brain ischemia and     systemic hypoperfusion than current techniques and measures such as blood pressure, heart     rate and intracranial pressure. Understanding the relationship between tissue oxygen tension     collected from the brain and deltoid muscle in critically injured patients could lead to a     broader understanding of the important metabolic and cellular events that occur following     severe injury and the changes induced by therapeutic interventions. Furthermore, the use of     interventions designed to improve tissue hypoxia, as measured by low brain or muscle tissue     oxygen, may improve mortality or neurological recovery after systemic trauma or head trauma     compared to current approaches that do not involve tissue metabolic monitoring.   "
188820|NCT00328354|"     The goal is to conduct a pilot study to determine the feasibility of the clinical use of     RMSSH SPECT imaging technology for breast imaging and to develop a standardized clinical     protocol.   "
188821|NCT00328367|"     The purpose of this study is to determine whether aripiprazole augmentation is safe and     effective in the treatment of clozapine-treated patients with refractory schizophrenia.   "
188822|NCT00328380|"     The primary objective of this study is to assess the safety and tolerability of rifaximin 600     mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy     subjects to prevent travelers' diarrhea (TD) from all causes.   "
188823|NCT00328393|"     The anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no     data are available looking at this effect in detail. Especially, ambulatory blood pressure     has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure     lowering effects.   "
188824|NCT00328419|"     The antioxidant system of very low birth weight infants is immature. This immaturity is     implicated in the pathogenesis of diseases such as bronchopulmonary dysplasia or retinopathy.     The main source of oxidant is oxygen, and parenteral nutrition is contaminated with oxidant.     Photoprotection decreases the oxidant load infused with parenteral nutrition. In a     preliminary study, photoprotection reduced the frequency of pulmonary bronchodysplasia,     increased the quantity of enteral nutrition tolerated, and decreased the arterial blood     pressure among very low birth weight infants. The aim of this study is to evaluate the impact     of photoprotection on oxidant related diseases among very low birth weight infants. This     study is a randomized multicenter trial. In the intervention group, photoprotection is     applied until the infusion of parenteral nutrition with amber bags, tubing, and syringes. The     quality of photoprotection is controlled by measuring malondialdehyde and cysteine after 24     hours of infusion. The control group will receive parenteral nutrition with transparent bags     and tubing. The outcomes are evaluated at 36 weeks, and 680 infants will be enrolled, with     stratification among centers and gestational age.   "
188832|NCT00328523|"     In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the     recommended target goal (esc 2003 recommendations ldl>=1.15 g/l) to compare the efficacy and     the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient     motivation on diet or physical activities or both).   "
188833|NCT00328536|"     The purpose of the study is to determine whether a 6-week treatment with 4 g Omacor/day     improves the baseline and postprandial endothelial function (after a high-fat meal) in     patients with type 2 diabetes mellitus.   "
188834|NCT00328549|"     The purpose of this study was to describe the time course and extent of hemoglobin (Hb)     changes and the erythropoietic response to PEG-IFN/RBV-induced anemia In HCV-infected     subjects.   "
188835|NCT00328562|"     The purpose of this study is to determine the safety and effectiveness of Iressa when used     with a short course of high dose radiation therapy in patients with lung cancer.   "
188836|NCT00328575|"     The purpose of this study is to determine if using intensity modulated radiation therapy for     brain metastases is safe and will improve local control more than standard whole brain     radiation therapy.   "
188837|NCT00328588|"     A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously     treated with chemotherapy.   "
188838|NCT00328601|"     The primary objective of the trial is to determine the optimal dose of orally (tablet)     administered thioctic acid in the treatment of symptoms of diabetic polyneuropathy (dPNP). It     is expected that at least one of the three dosages to be tested (600, 1200, or 1800 mg     tablets) of orally administered thioctic acid improves the symptoms of dPNP as compared to     placebo.      Secondary objectives are evaluations of other variables pertinent to dPNP, safety, and     tolerability.   "
188842|NCT00328653|"     The primary objective of this study is:        -  To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus          vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment          period.      The secondary objectives of this study are:        -  To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%;        -  To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and        -  To assess the decrease in frequency of concomitant artificial tears use.   "
188843|NCT00328666|"     The purpose of this study is to compare the effects of 12 weeks of structured classes of     either iyengar yoga (IY) or an enhanced usual care intervention on blood pressure, heart rate     variability, quality of life measures, lipid measures, and safety in patients with     high-normal to stage I hypertension.   "
188844|NCT00328679|"     The main purpose of this study is to determine if standard and investigational tests used to     help diagnose and treat food allergies can provide information that will be useful in     determining the cause of dyspepsia and helpful in designing a treatment plan. The study will     also determine if there is a connection between positive allergy tests and inflammation in     the upper abdomen.   "
188845|NCT00328692|"     The study is being conducted to examine whether KW-3902IV will result in greater improvement     in signs and symptoms of heart failure, with less treatment failure than standard therapy,     when it is added to IV loop diuretics in subjects with acute heart failure syndrome and renal     impairment.   "
188846|NCT00328705|"     This is an acute, prospective, multi-center, non-randomized, investigational device exemption     (IDE) clinical study.   "
188847|NCT00328718|"     This study is being conducted to demonstrate the superior clinical effectiveness of     Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent     asthma in children aged 6-14 years, and to assess the effect of each treatment     [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)] on lung function,     asthma control, Health Outcomes including the child's quality of life as measured by     Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life     as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at     selected centers where a valid translation is available.   "
188848|NCT00328731|"     We sought to determine the efficacy of NAET® in permanently eliminating milk allergy for a     sample of patients.      We hypothesize that the subjects in the experimental group will show similar level of     allergies and sensitivities initially on all nine diagnostic measures used here. After     receiving the NAET treatments, the Experimental group will demonstrate a significant     reduction in the milk sensitivities and allergies when compared to the control group at the     final evaluation using same diagnostic measures.   "
188861|NCT00328900|"     24 patients randomly divided into two groups, one of the groups receiving atropine in     addition to the planned anaesthesia. Skin conductance parameters to be compared between the     two groups.   "
188862|NCT00328913|"     The aim of the study is to show evidence of the efficacy of 5-HTP to induce satiety and to     reduce food intake (confirmatory study).      The primary objective of the present study is to determine:        -  the effectiveness of a 5-HTP preparation on satiety markers (before intake of a meal and          during the day)      The secondary objectives of the present study are to determine the effectiveness of a 5-HTP     preparation on:        -  food consumption (amount and composition) during a free meal (dinner);        -  wellness after one week supplementation;        -  the intermeal interval;        -  body weight and waist-hip ratio (WHR).   "
188863|NCT00328926|"     Sponsor has decided to discontinue Luveris® in the United States (US) due to level of     customer demand for this product, and not due to any efficacy or safety concerns.   "
188864|NCT00328939|"     This is a local registration study in China to compare the safety and efficacy of ARIXTRA to     Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of     components.   "
188849|NCT00328744|"     The rising prevalence of obesity in the United States is believed to be due to increased     exposure to adverse environmental factors, such as food portion sizes and increased dietary     variety. Although decreasing portion sizes is a strategy used in weight loss programs,     research has not studied the effects of decreasing dietary variety. Cross-sectional studies     show a positive association between variety and body weight and in our own studies the     investigators have shown that greater reductions in the number of different snack foods     (i.e., cookies, chips) consumed predicted greater decreases in overall caloric and fat intake     and greater weight loss. Limiting variety may reduce intake through long-term     sensory-specific satiety and/or monotony. Reducing dietary variety is a novel dietary     approach with the potential to improve long-term weight loss, which has not been studied as a     clinical strategy in obesity research. The objective of this application is to conduct a     randomized controlled trial of a behavioral weight loss intervention limiting the number of     different snack foods consumed. Two hundred overweight and obese participants will be     randomized to a standard behavioral intervention (Standard) or to a standard behavioral     intervention that also limits the number of different snack foods consumed (Limited Variety).     Both conditions will receive an 18-month standard behavioral intervention, using behavioral     techniques (i.e., self-monitoring) to change eating behaviors. Participants in the Limited     Variety condition will also limit variety in snack foods to only two chosen snack foods     throughout the intervention. Measures of weight, snack food consumption and hedonics, and     diet satisfaction will be taken at 0, 6, 12, and 18 months. This investigation will     determine:        1. if the Limited Variety condition produces greater weight loss than the Standard          condition at 18 months;        2. if the Limited Variety condition consumes fewer servings and calories from snack foods          than the Standard condition;        3. if limiting snack food variety produces long-term sensory-specific satiety and/or          monotony.      Relevance: Experimental studies show that limiting dietary variety profoundly reduces intake.     To date, there is no dietary prescription that has been tested that capitalizes on the effect     of variety on intake that can be maintained. This will be the first investigation to examine     methods of manipulating dietary variety that can be adhered to over time and that influence     intake, weight loss, and weight loss maintenance.   "
188850|NCT00328757|"     The purpose of this study is to determine whether it is safe to give a regular diet as the     first postoperative meal in patients who underwent surgical treatment for clinically     early-stage gynecologic cancer.   "
188851|NCT00328770|"     This study investigates whether sirolimus could decrease the rate of hepatoma recurrence     after liver transplantation in high risk hepatoma patients.   "
188852|NCT00328783|"     The purpose of this study is to evaluate the use of a device that helps coordinate the     breathing cycle in the radiation treatment of the breast in order to minimize the radiation     dose to the normal structures around the breast.   "
188853|NCT00328796|"     Midwives and obstetricians are currently using acupuncture for several health problems during     pregnancy and childbirth. The investigators wish to determine whether acupuncture can be used     as pain relief during the repair of lacerations in the female pelvic floor following     childbirth.      Three acupuncture points in the ear have been reported highly effective for perineal pain     relief. A scientific trial will compare acupuncture with traditional local anaesthetics when     midwives conduct perineal repair just after delivery in the hospitals of Southern Denmark.   "
188854|NCT00328809|"     Cardiovascular disease is the leading cause of death and disproportionately prevalent in     patients with kidney disease. Spironolactone has been shown to improve survival in the     general population with heart failure by up to 30%. We wish to study the safety and     tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk     population of patients on hemodialysis. We will study and closely monitor subjects over a     period of 12 months, during which they will be receiving spironolactone for a period of 6     months.   "
188855|NCT00328822|"     Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine   "
188856|NCT00328835|"     Chronic glaucoma is one of the leading causes of blindness and visual loss in the developed     world. It is a condition where long term exposure to high eye pressures (intra-ocular     pressure) damages the nerve fibres in the eye. This damage can be seen by examiners as     changes in the optic nerve. The exact mechanism of how the high intra-ocular pressure causes     nerve damage is unknown. Both physiological and mechanical mechanisms are thought to play a     role. Previous authors have reported structural changes in the connective tissue of optic     nerves of eyes with glaucoma. Structural changes in the optic nerve head which affect the     mechanical compliance of the nerve may be significant in the cause of glaucomatous nerve     damage. This study aims to assess the compliance of the optic disc in subjects with and     without glaucoma. We would test compliance by imaging the optic discs of participants before     and during a brief (less than two minutes) increase in intra-ocular pressure. We would aim to     repeat the tests on the same subjects 3 years later to see how compliance changed. We would     also seek to correlate other important parameters such as corneal thickness and visual field     changes with our findings   "
188857|NCT00328848|"     The purpose of this study is to determine whether comprehensive post-hospitalization     interdisciplinary care management can be an effective care delivery model to improve outcomes     in low-income frail elderly.   "
188858|NCT00328861|"     Background:        -  Natural killer (NK) cells are large lymphocytes (a type of white blood cell) that are          important in the immune response to cancer.        -  IL-2 (Aldesleukin) is a substance the body makes that controls the growth and function          of many types of cells. The Food and Drug Administration has approved IL-3 for treating          metastatic melanoma and kidney cancer. (Metastatic disease is cancer that has spread          beyond the primary site.)      Objectives: To determine the safety and effectiveness of treating metastatic melanoma and     kidney cancer with laboratory-treated NK cells and IL-2.      Eligibility: Patients 18 years of age or older with metastatic melanoma or kidney cancer who     have previously been treated with high-dose IL-2.      Design:        -  Leukapheresis. Patients under leukapheresis to obtain NK cells for the treatment          regimen. Blood is collected through a needle in an arm vein and directed through a cell          separator machine where white blood cells are extracted. The rest of the blood is          returned to the patient through a needle in the other arm. NK cells are removed from the          white blood cells and treated for re-infusion into the patient.        -  Chemotherapy. Starting 8 days before infusion of the treated NK cells, patients receive          intravenous (IV, through a vein) infusions of cyclophosphamide and fludarabine to          suppress the immune system.        -  NK cell infusion. Patients receive a 30-minute IV infusion of NK cells 2 days after the          last dose of chemotherapy.        -  IL-2 therapy. Within 24 hours of the NK cell infusion, patients receive high-dose IL-2          as a 15-minute IV infusion every 8 hours for up to 5 days. A second cycle of IL-2 is          given about 14 days after the first.        -  Blood tests and biopsy. Patients have frequent blood tests during the treatment period          and may be asked to undergo a biopsy (surgical removal of a small piece of tumor or          lymph node) at the end of treatment to look at the effects of the treatment on the tumor          immune cells.        -  Follow-up evaluation. Patients are evaluated 4-6 weeks after completing treatment. They          have a physical examination, scans of tumor sites, blood tests and blood sampling (or          leukapheresis) to examine the response to treatment. Patients who improve with treatment          return for evaluations every month. Those whose tumor grows again after originally          shrinking may receive one additional treatment course.   "
188859|NCT00328874|"     Study hypothesis:      A 6-week p.o treatment with 5 mg/Kg Coenzyme Q10 is safe and tolerable,increases the brain's     metabolism and ameliorates clinical symptoms in patients with PSP.   "
188860|NCT00328887|"     This a pilot clinical study focused on enhancing the patient's anti-tumor immune response in     individuals with esophageal cancer by altering the genetic repertoire of the tumors to     express CD40L, an activator of dendritic cells. This will be accomplished by endoscopic     administration to the tumors of AdcuCD40L, an adenovirus gene transfer vector expressing the     coding sequence of the human CD40L cDNA. This study is designed to assess the hypothesis that     it is safe to administer the AdcuCD40L vector to individuals with esophageal cancer.   "
188867|NCT00328978|"     The purpose of the study is to assess and compare the side effect profile, safety,     tolerability and efficacy of schizophrenic or schizoaffective subjects non- or partially-     responsive to 800 mg/day of quetiapine treated with either 800 mg/day or more than 800 mg/day     of quetiapine during 8 weeks.   "
188868|NCT00328991|"     This study is a double-blinded, controlled clinical intervention trial to evaluate the     efficacy of duct tape occlusions therapy for the treatment of common warts. 80 patients     completed this study, and were randomized 1:1 to receive pads which contained either     moleskin+transparent duct tape or moleskin alone. The patients wore the pad over the target     wart for 7 days at a time, removed the pad on the evening of the 7th day, and replaced the     pad on the 8th day. This cycle was repeated for 8 weeks or until the wart resolved. The     hypothesis was that duct tape occlusion therapy would be more therapeutic than moleskin for     the treatment of the common wart. However, in our study there was only 21% resolution rate in     the duct tape arm vs. 22% in the control group.   "
188869|NCT00329004|"     The purpose of this research study is to determine the highest dose of the drug (BMS-690514)     that can be safely given to patients with advanced cancer.   "
188870|NCT00329017|"     A study to examine the potential associations between common single nucleotide polymorphisms     and pre-cancerous conditions in breast tissue specimens from postmenopausal women.   "
188871|NCT00329030|"     This study is designed as a Phase III, multicenter trial, comparing progression-free survival     (PFS) after autologous hematopoietic stem cell transplantation using a standard Rituxan plus     BEAM transplant regimen versus a regimen adding Bexxar to BEAM.   "
188872|NCT00329043|"     The goal of this clinical research study is to learn if the addition of sunitinib malate     (SU011248) to hormone based castration is an effective treatment for shrinking or controlling     the tumor before having the prostate removed.   "
188886|NCT00329225|"     This 24-week study will compare the effects of adding the drug rosiglitazone (2mg and 4mg) or     placebo to insulin in patients with Type 2 diabetes mellitus (non-insulin-dependent) who have     not achieved their blood glucose goal using insulin alone. This study requires a total of     seven visits during 28 weeks.   "
188983|NCT00311545|"     RATIONALE: Monoclonal antibodies, such as CNTO 328, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them.      PURPOSE: This phase II trial is studying how well CNTO 328 works in treating patients with     unresectable or metastatic kidney cancer.   "
188873|NCT00329056|"     In Parkinson's Disease, the mitochondrial membranes in cells that produce dopamine become     damaged by oxidants, leading to the death of these cells and progressive tremor, slowness of     movement and the loss of neurons in the substantia nigra (a part of the brain that is     involved in movement). Mitoquinone is targeted to reach the membrane of mitochondria and     provide protection from damaging oxidants. There are no treatments currently available to     slow the progression of PD and this trial will help advance the development of this unique     disease modifying drug.      This trial will enroll 120 participants with untreated early onset of PD. Participants will     be randomized to receive 1 of 3 treatments: 40 mg of MitoQ tablets, 80 mg of MitoQ tablets or     placebo. The researchers, participants and sponsor will all be blinded to the treatment     allocation. Participants will be assessed after 1, 2, 3, 6, 9, 12 months of treatment and     again 28 days after their last dose. The effectiveness of the trial drug will be measured via     the Unified Parkinson's Disease Rating Scale (UPDRS). The safety of the trial drug will be     monitored via regular participant examinations, blood tests, ECG and collecting information     on adverse events.   "
188874|NCT00329069|"     The aim of this study is to determine, whether an intensified atorvastatin therapy can     improve monocyte function in patients with coronary artery disease and hypercholesterolemia.   "
188875|NCT00329082|"     To study the safety of LY2062430 in patients with mild-to-moderate Alzheimer's disease and in     healthy volunteers.   "
188876|NCT00329095|"     This is an open-label study in patients who are currently using either a topical     prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin     plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the     same eye(s). Compliance will be measured over the two months of participation.   "
188877|NCT00329108|"     The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus     olanzapine in the treatment of acute mania. An open label extension will further evaluate the     efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Study recruitment     was stopped due to difficulty in enrolling the targeted number of patients on July 30, 2007.     Subjects that were enrolled at the time completed the study as per protocol. There were no     safety concerns involved in the decision to stop enrollment. The Last Subject Last Visit was     January 10, 2008.   "
188878|NCT00329121|"     The purpose of this study is to determine whether the topical application of PEP005 is safe     and effective for the treatment of cutaneous squamous cell carcinoma in situ (SCCIS, Bowen's     disease).   "
188879|NCT00329134|"     No pediatric formulations of quinine exist. Therefore, quinine tablets are broken into 2 or 4     parts, according to the body weight. Based on the body weight, 1/2 or 1/4 a tablet is     administered to the child.      At this moment, quinine sulphate pellets are developed. These pellets enable an adequate     dosing according to the body weight.      56 children with malaria will be dosed every 8 hours during 7 days with 10-15mg/kg body     weight.   "
188880|NCT00329147|"     The purpose of this study is to evaluate the effects of multiple doses of DVS SR and     paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.   "
188881|NCT00329160|"     The primary objective of this study is to evaluate that 76 weeks of treatment with     rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic     volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic     subjects with coronary heart disease (CHD).   "
188882|NCT00329173|"     To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin     after 6 weeks treatment   "
188883|NCT00329186|"     The purpose of this study is to determine if the relative difference in PK between extensive     metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and     venlafaxine ER when a single dose is administered.   "
188898|NCT00329381|"     In patients with at least moderate persistent allergic asthma controlled with inhaled     steroids, omalizumab(administered per US product label), when compared to placebo, will     provide the participants with significantly improved tolerability of specific allergen     immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).   "
188976|NCT00311454|"     The study is required by the FDA as part of a post-marketing commitment. The purpose of the     study is to compare the reactivity of the TRUE Test quaternium-15 patch and a real use     exposure.The subjects will wear the patch test for 48 hours and reading will be performed day     3 or 4. The use test will be applied from day 3 or 4 and untill reaction appears. Reactions     from respectively TRUE Test and use test will be compared using the McNemar Change Test.   "
188884|NCT00329199|"     Through the TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy;     Project 3a) we aim to test the efficacy of a brief treatment aimed at treating depression and     family conflict among a population of adolescents with depression, and thereby reducing the     future chance of these adolescents initiating smoking. We will examine Attachment-Based     Family Therapy (ABFT) for the treatment of depression in comparison with Enhanced Usual Care     for Depression (EUCd). Reduction of depression will be measured by a clinically significant     reduction of score on the Hamilton Rating Scale for Depression. Second, we will examine how     reduction of family conflict mediates the effect of ABFT on depression. The third aim will be     an exploratory look at the potential prevention of the onset of smoking. Specifically, we     will examine if reduction of depression and/or reductions in family conflict regardless of     treatment type reduces the initiation of smoking or reduces smoking behavior at 52 weeks.     These aims will be accomplished by randomizing 240 adolescents to one of two treatment     conditions: a) Attachment-Based Family Therapy or b) Enhanced Usual Care for Depression.     Patients randomized to the ABFT condition will receive 6-12 weeks of family therapy. Patients     enrolled in the EUCd condition will be referred for outpatient psychological services at an     agency that fits their geographic and financial needs. Research staff will help patients     navigate the referral process. All participating therapists will have carried out the full,     manualized treatment with 2-3 pilot cases prior to treating any randomized cases.   "
188885|NCT00329212|"     The purpose of this study is to investigate the pharmacokinetics in humans of San Huang Xie     Jin Tang (SHXJT) and evaluate the bioequivalence between herbal concentrate and traditional     decoction.   "
188927|NCT00329758|"     The purpose of this study is to determine whether rosuvastatin is effective in the management     of moderate head injury by improving amnesia and orientation.   "
188887|NCT00329238|"     The general aim of this study is to determine the comparative safety and efficacy of     dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR)     of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous     thromboembolism in patients who have been successfully treated with standard doses of an     approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous     Thrombo-embolism.   "
188888|NCT00329251|"     The purpose of this study is to determine whether an immunization schedule is beneficial to     HIV-infected patients with CD4 recount over 500 cells/mm3 and undetectable viral load.   "
188889|NCT00329264|"     The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and     safe in the acute treatment of patients with Generalized Anxiety Disorder.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
188890|NCT00329277|"     Standard perimetry provides information on topographical retinal sensitivity to light     stimuli, however the said locus is not necessarily the preferred locus for fixation. Standard     perimetry could also be used as a way for macular scotoma mapping, indirectly showing the     fixation locus. Topographic acuity at the preferred retinal locus can be determined if     correlation between loci with high sensitivity, eccentric fixation loci and potential visual     acuity measurements are correlated.      PURPOSE OF THE STUDY:      Determination of visual acuity at preferred retinal locus in Low Vision patients with ARMD     using eye standard automated and computerized perimetry methods.   "
188891|NCT00329290|"     The ability to diagnose and surgically repair poorly functioning heart valves has yielded a     significant population of women that are of childbearing age with mechanical/ bioprosthetic     heart valves. The clinical management of pregnant women with artificial heart valves during     pregnancy has been difficult. Currently there have not been any controlled clinical trials to     provide guidelines for a safe and effective anticoagulation. Current review of the literature     has shown that oral anticoagulation with warfarin has been implicated to cause significant     fetal morbidity including prematurity, decreased birth weight, birth defects (i.e.:warfarin     embryopathy), abortions, still birth and neonatal mortality. Warfarin embryopathy refers to     characteristic anomalies (nasal hypoplasia, eye defects, hypoplasia of extremities, deafness,     mental and developmental retardation), that may occur when coumadin is used during first     trimester and/or if used in doses >5mg per day during pregnancy. It has also been reported     that intravenous and subcutaneous heparin has not been sufficiently effective in lowering     maternal morbidity and mortality. Thromboembolic events, valve dysfunction leading to     peripartum valve replacements, and maternal death have all been observed.      The purpose of this study is to:        -  Evaluate the outcome of pregnancy in women with mechanical/bioprosthetic heart valves.        -  Identify the risks posed to both mother and fetus during treatment with various methods          of anticoagulation during pregnancy.      The survey will be conducted in three phases:      Physicians who respond to:      Phase 1: A questionnaire asking physicians whether they have cared for a patient with     prosthetic heart valve after year 1990 will be mailed, faxed or e-mailed to all members of     the Society of Maternal Fetal Medicine.      Phase 2: Responding physicians will provide information for the investigators to contact     their patients and obtain a telephone/signed consent form (approved by the LBMMC IRB) to     participate in the study and release their medical records to the investigators.      Phase 3: Data will be collected by the investigators/research nurse by reviewing medical     records and interviewing referring physicians and the patients.      Although the information may not have immediate benefit to the subject, the data collected     may help the medical community develop a more effective guideline of selection of prosthetic     valves in women in the childbearing age and care of patients with prosthetic heart valves     during pregnancy.   "
188892|NCT00329303|"     The primary objective is to assess the effect of re-treatment after relapse in subjects with     moderate to severe chronic plaque psoriasis having responded to a first treatment.   "
188893|NCT00329316|"     To examine the preterm delivery rate of a preterm delivery high risk group of pregnant women,     using once daily natural progesterone agent.   "
188894|NCT00329329|"     The purpose of this study is to determine the maximally tolerated dose (MTD) and Phase 2     recommended dose of satraplatin when administered in combination with capecitabine in     patients with advanced solid malignancies.   "
188895|NCT00329342|"     Low back pain has become a major concern to employees and employers because of its negative     impact on employee health and productivity.      The objective of this study is to investigate whether a return-to-work intervention conducted     during inpatient rehabilitation improves functional limitations that are related with low     back pain and interfere with job performance.   "
188896|NCT00329355|"     This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium),     formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.   "
188897|NCT00329368|"     This is a Phase 1b clinical trial to assess the safety and tolerability of vaccination with     EC90 (KLH-FITC) and GPI-0100 (adjuvant) followed by treatment with EC17 (Folate-FITC) in     combination with low-dose cytokines (IL-2 and IFN-alpha) in patients with metastatic or     refractory cancer.   "
188899|NCT00329394|"     The principal objective is to evaluate the analgesic effectiveness of the systemic ketamine     on the control of the pain (average consumption of morphine at 48 hours) at the     alcool-dependent patient, in carcinological surgery ORL. The effect coanalgesic is found for     low dose of ketamine and action anti NMDA seems to have a stabilizing effect on this     particular type of patient. This imbalance of the receivers, with a greater number of r-NMDA     among these patients would involve it a better analgesic effectiveness and less effects     dysphoric, to see an improvement on the syndrome of weaning. The secondary objectives     evaluate the pain, the ground (dependence with alcohol), the first request analgesic, the     tolerance and the signs psychic (syndrome of weaning...) and the satisfaction of the patient.   "
188900|NCT00329407|"     This investigation will assess the effectiveness of topiramate in reducing ethanol     consumption by alcohol dependent subjects. It also will seek to establish whether topiramate     can be safely used in this population including whether it might be subject to abuse by     alcohol dependent individuals.      A secondary goal of this study is to assess the effects of topiramate on verbal fluency     during treatment for alcohol dependence.   "
188901|NCT00329420|"     This 26-week extension study evaluates the efficacy and safety of certolizumab pegol     administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects     with active Crohn's disease who had no clinical response at Week 6 to induction therapy in     the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical     response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this     extension study.   "
188943|NCT00311025|"     The purpose of this project is to follow first-ever- acute stroke patients from onset, one,     two and four years post stroke and study the effect of two different approaches of exercises     implemented the first year post-stroke.   "
188944|NCT00311038|"     The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients     scheduled for multi-slice CT.   "
188902|NCT00329433|"     A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most     common complications after surgery. This may result in death if a clot breaks off and travel     to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the     incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In     order to decrease the likelihood of this complication, patients receive by injection a blood     thinning medicine. Heparin is the usual medicine used for this purpose following heart and     lung surgery. Recently there have been reports that other medicines may be more effective     than heparin for this purpose. Also there have been reports that some patients develop     antibodies to heparin. When this occurs, this may prevent the heparin from being effective     and may even promote the formation of blood clots. Antibodies to heparin may be present more     often following heart and lung surgery than other types of surgery. There is a new medicine     called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots     following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood     clots following hip surgery. The purpose of this study is to compare desirudin with heparin     for the prevention of vein clots after heart and lung surgery.   "
188903|NCT00329446|"     The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and     safe in the acute treatment of patients with Generalized Anxiety Disorder.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
188904|NCT00329459|"     This study was designed to determine efficacy of TREXIMA compared to placebo for the     treatment of a menstrual migraine.   "
188905|NCT00329472|"     This study is randomized phase III trial designed to assess whether (preoperative)     neoadjuvant chemotherapy followed by surgery plus adjuvant chemotherapy with gemcitabine and     cisplatin (experimental treatment) improves 3-year disease-free survival, compared to surgery     plus adjuvant chemotherapy with gemcitabine and cisplatin (standard treatment) in stage IB,     IIA, IIB and T3N1 non-small cell lung cancer   "
188906|NCT00329485|"     The purpose of this research study is to test the effectiveness of CORvalen, a medical food,     to increase cellular energy sufficiently to change or modify BNP levels in congestive heart     failure patients.   "
188907|NCT00329498|"     To document therapeutic gain achieved by cyclic application of L-ascorbic acid (LAA)     supplementation and depletion, while confirming safety and avoidance of clinically     significant scurvy, in chemorefractory patients with acute myeloid leukemia (AML) and     myelodysplastic syndromes (MDS).   "
188908|NCT00329511|"     High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is     associated with an increased risk of development of pregnancy related high BP called     preeclampsia, preterm delivery, decreased growth of the fetus, fetal death, premature     separation of the placenta from the uterus resulting in damage to the fetus and cesarean     delivery. Longer duration and severity of CHTN in pregnancy leads to worse outcomes for the     mother and the fetus. Treatment of mild CHTN in pregnancy does not improve these outcomes,     and therefore, medications to lower BP are used for moderate to severe hypertension. To date     the literature on the medications used in pregnancy is extremely limited.      Methyldopa is used as a first choice medicine for CHTN in pregnancy. It acts on the central     nervous system (CNS) by relaxation of the blood vessels leading to a decrease in BP. It does     not decrease the blood flow to the uterus, placenta, or the fetus (4). Methyldopa is a weak     antihypertensive medicine given three or four times a day and frequently needs changes in the     dose or may require an additional medication to control BP. This may lead to a greater chance     of non compliance. Another option is Clonidine which is an effective antihypertensive     treatment and is available in many forms (oral, parenteral, and transdermal.) It acts on the     maternal CNS. Clonidine is not associated with teratogenic or neonatal side effects.     Transdermal clonidine (catapres-TTS®) is a preparation of clonidine hydrochloride that can be     released and absorbed transdermally over a 7-day period.      The study will determine differences in compliance between the two antihypertensive regimens-     oral methyldopa and Catapres-TTS, comparisons of patient tolerability, compliance and     adequacy of BP control, as well as provide information on an alternate option for BP control.   "
188957|NCT00311207|"     Pulmonary tuberculosis is one of the most important infectious diseases in human with high     mortality.      Early diagnosis followed by antibiotic treatment is the only way for control of the disease.     However, most of commercial tuberculosis diagnostic kits are of moderate sensitivity.     Oncoprobe Inc. recently developed a tuberculosis diagnostic kit (HR-103) based on detection     of antibody against Mycobacterium tuberculosis in serum. The main purpose of this project is     to evaluate the sensitivity and specificity of the kit in detection of pulmonary tuberculosis     from saliva, urine, pleura and serum samples.Capilia TB assay and another     Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based     immunochromatographic assay will be tried to detection tuberculous disease.   "
188909|NCT00329524|"     One out of every five people experience tinnitus (a buzzing, ringing, or roaring sound in the     ear) ranging from mild to severe impairment. To date there is no effective therapy that seems     to help the tinnitus sufferer. The purpose of this study is to develop a therapy using a     technique called Repetitive Transcranial Magnetic Stimulation (rTMS) to hopefully alleviate     or reduce the symptoms of tinnitus.      This research is being conducted at the University of Arkansas for Medical Sciences (UAMS).     Up to twenty (20) right handed subjects, either males or females, 19-65 years of age, with     tinnitus that is severe enough for those persons to seek medical attention will have been     seen as patients in the UAMS Hearing and Balance Center, where routine testing includes a     physical exam, hearing tests, evaluation of middle ear status, and an MRI scan (a machine     that acquires visual images of the brain). A diagnosis of tinnitus will be established after     ruling out all other possible causes of the tinnitus.   "
188910|NCT00329537|"     The purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and     6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to     assess the efficacy and safety of 6 micro g/kg/day sargramostim administered subcutaneously     once daily for 8 weeks in comparison with placebo, in patients with moderately to severely     active Crohn's disease.   "
188911|NCT00329550|"     This is a multi-centre, open-label extension study in subjects who showed clinical response     to induction therapy in the treatment of subjects with active Crohn's disease in the     double-blind main study C87037 (NCT00291668).   "
188912|NCT00329563|"     The overall goal of this study is to determine the feasibility of initiating hypothermia in     cardiac arrest patients as soon as possible in the field. In this pilot study we will     randomize 125 patients after return of spontaneous circulation (ROSC) to hypothermia with     rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV     sedation and muscle paralysis or to standard of care following ROSC. The primary objectives     of this study will be to determine whether temperature of 33-34oC can be achieved and     maintained using this strategy. The primary outcome measures will include: temperature     changes of the patients at time of admission to the hospital. Secondary analysis will include     determining if the proportion of patients discharged from the hospital is increased in the     group receiving hypothermia. If this initial pilot study can demonstrate feasibility in     achieving and maintaining hypothermia, a larger randomized clinical trial to test the     hypothesis that hypothermia initiation in the field will increase the proportion of patients     surviving following cardiac arrest will be planned.   "
188913|NCT00329576|"     To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years     after the first dose of the hepatitis B in the primary vaccination study.   "
188914|NCT00329589|"     The purpose of this study is to determine the safety of Velcade when used with chemoradiation     in cancer patients.   "
188915|NCT00329602|"     This is an initial placebo-controlled study followed by open treatment evaluating the     effectiveness and tolerability of ropinirole long-term in patients with moderate to severe     Restless Legs Syndrome.   "
188916|NCT00329615|"     The study is designed to evaluate whether daily insulin treatment to weight losing cancer     patients attenuates progression of cancer cachexia and improves metabolism.   "
188917|NCT00329628|"     The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is     safe and prevent blood clot which may form after total hip replacement operation.   "
188918|NCT00329641|"     This phase II trial is studying how well sorafenib works when given together with carboplatin     and paclitaxel in treating patients with stage IV melanoma of the eye. Drugs used in     chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may     help carboplatin and paclitaxel work better by making tumor cells more sensitive to the     drugs. Sorafenib may also stop the growth of melanoma by blocking some of the enzymes needed     for tumor cell growth and by blocking blood flow to the tumor. Giving sorafenib together with     carboplatin and paclitaxel may kill more tumor cells.   "
188919|NCT00329654|"     This will be a prospective, randomized, single blinded, controlled study in a single center     setting to assess the effect of either phototherapy with the Embar® light therapy or sham     irradiation.   "
188920|NCT00329667|"     This study is a multi-center, prospective, non-randomized, observational study. The     objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic     valve.   "
188921|NCT00329680|"     The scope of this clinical study is to evaluate the possible role of an enteral formulation     enriched with EPA, GLA and Antioxidants in patients diagnosed in the early stages of sepsis     despite mechanical ventilation requirements, as well as the impact of this diet upon glycemic     control and its capacity to prevent the development of sepsis into severe sepsis and septic     shock.   "
188922|NCT00329693|"     Women included in this study are undergoing controlled ovarian hyperstimulation for assisted     reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.   "
188923|NCT00329706|"     A brain PET scan is recognized as reasonable and necessary for some patients with a     recently established diagnosis of dementia (Centers for Medicare and Medicaid Services,     Decision Memo CAG-00088R, 2004), but evidence is less clear for patients having less severe     cognitive problems. A substantial portion of such patients will develop Alzheimer's disease     and other forms of dementia, which affect millions of people in the U.S., costing us over     $100 billion annually. This project employs a prospective randomized protocol to determine     whether PET scanning can help distinguish those patients with early Alzheimer's changes in     their brains from those having other causes of cognitive impairment more accurately than is     done with current clinical practices alone, and lead to earlier, more effective therapies     which extend patients' abilities to think and function independently.   "
188924|NCT00329719|"     This phase I/II trial is studying the side effects and best dose of temsirolimus when given     together with sorafenib and to see how well they work in treating patients with recurrent     glioblastoma. Sorafenib may stop the growth of tumor cells by blocking blood flow to the     tumor. Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Sorafenib and temsirolimus may also stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Giving sorafenib together with temsirolimus may kill more     tumor cells.   "
188925|NCT00329732|"     Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of     headache. The GONB procedure involves a series of injections into the greater occipital nerve     (a spinal nerve located at the back of your head). The purpose of this study is to determine     whether GONB is effective for the treatment of prolonged migraine attacks. This study is     placebo controlled, which means that half of the patients participating will receive     injections of active study drug (lidocaine plus bupivicaine) and half of the patients will     receive injections of saline (placebo). The study is also blinded which means that neither     you nor the study staff will know whether you received active study drug or placebo. The     study remains blinded only for the first 30 minutes, at which point additional treatments     (including GONB) can be administered at the discretion of your treating physician.      40 patients are expected to participate in this research study. This study is being conducted     at Thomas Jefferson University only.   "
188926|NCT00329745|"     This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine     efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in     infants previously vaccinated with human rotavirus (HRV) vaccine or placebo in the following     schedules:      at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or     rota-030.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
188928|NCT00329771|"     Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a     heightened skin sensitivity during an active migraine attack. Migraine attacks in patients     who experience allodynia are more difficult to treat. This study intends to collect and     evaluate data on the phenomenon of allodynia in patients with episodic migraine during an     actual attack. The results of this study may help clinicians better understand allodynia,     thereby helping them diagnose and more effectively manage patients with migraine and     allodynia.   "
188929|NCT00329784|"     This study will evaluate whether early exposure to peanuts promotes tolerance and provides     protection from developing peanut allergy in children who are allergic to eggs or who have     severe eczema.      This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).   "
188930|NCT00329797|"     RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing     radiation therapy and hormone therapy. It is not yet known whether zoledronate is more     effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in     patients with prostate cancer.      PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works     compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in     patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and     hormone therapy.   "
188931|NCT00329810|"     To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic     patients.   "
188932|NCT00329823|"     The rationale of the protocol is based on the reported beneficiary results of case-patients     by the administration of other anti-TNF drug (infliximab) in separate cases on the grounds of     a probable autoimmune predisposition of the disease. The objective of this study is to     clarify the potency of etanercept for the therapy of hidradenitis suppurativa.   "
188933|NCT00329836|"     This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous     allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli     (e.g. light touch) are applied to the skin. Many studies have been performed looking at the     presence of cutaneous allodynia in patients with migraines; however, few studies have     examined it in cluster headache patients. There is still much to be learned about the brain     and how it functions if the investigators are to understand the underlying causes of cluster     headache. It is important to explore cutaneous allodynia in cluster headache as it may help     guide physicians with the care of these individuals. Sixty patients will be screened for this     study. Thomas Jefferson University is the only center enrolling patients in this research     study.   "
188934|NCT00329849|"     Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in     children 2 to 10 years of age   "
188935|NCT00329862|"     Laparoscopic Adjustable Gastric Banding (LAGB) is a gold standard in the surgical treatment     of morbid obesity. We hypothesize that the addition of truncal vagotomy (cutting of nerves to     the stomach) will produce greater weight loss and better reduction of co-morbidities     (diseases caused by or aggravated by morbid obesity) than LAGB alone. 25 patients will be     enrolled and outcomes compared to LAGB historical controls over a post-operative period of 24     months.   "
188936|NCT00329888|"     Compare endoscopic papillary balloon dilatation vs. endoscopic sphincterotomy for bile duct     stones in:        -  when sphincterotomy is difficult (periampullary diverticulum, prior sphincterotomy or          Billroth II anastomosis)        -  when there is distal CBD tapering.   "
188937|NCT00329901|"     Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and     Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years   "
188938|NCT00310960|"     The purpose of this study is to:        -  To estimate the duration of misalignment by age at presentation in infantile esotropia          (infantile ET), acquired non-accommodative esotropia (ANAET) and acquired partially          accommodative esotropia (APAET).        -  To determine the proportion of patients with angle instability in infantile ET, ANAET          and APAET by length of follow-up.   "
188939|NCT00310973|"     This study will evaluate the effectiveness of peer-led HIV/sexually transmitted disease     (STD)risk reduction educational counseling in reducing HIV risk behavior among the social     networks of young men who have sex with men and Roma men and women in Bulgaria and Hungary.   "
188969|NCT00311363|"     The primary objective of this trial is to assess the maintenance of efficacy of gabapentin     enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering     from Restless Legs Syndrome (RLS).   "
188970|NCT00311376|"     The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A     in treating overactive bladder in spinal cord injury or multiple sclerosis patients.   "
188971|NCT00311389|"     The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a     combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.   "
188940|NCT00310986|"     In 2004, the Developmental Clinic of the Child Psychiatric Unit at Srinagarind Hospital, had     80 new pediatric cases of attention deficit hyperactivity disorder (ADHD) come for evaluation     and intervention. The children were between 7-12 years of age. Most of them were treated with     stimulant medication, (i.e. methylphenidate) to help reduce hyperactivity; however, both the     parents and children needed special help to develop some techniques for behavioural     management.      Meditation has been used as an attention training method for many thousands of years, and was     mostly involved with religious or spiritual practices in various parts of the world,     especially in the eastern countries. Breathing meditation is a popular method which can be     applied to all people without instructions that are too complicated. If meditation therapy,     by breathing meditation which is specified to treat attention deficit hyperactivity     disorders, benefits this group of patients, it would be very useful, culturally appropriate,     cost-effective and would reduce the drugs used which will save the child from drug side     effects.   "
188941|NCT00310999|"     Patients undergoing surgery will have laryngoscopy performed using two widely accepted     techniques – Macintosh Laryngoscope and Shikani Optical Scope. The techniques will be timed     and compared for cervical spine movement using fluoroscopy.   "
188942|NCT00311012|"     This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with     essential hypertension.   "
188946|NCT00311064|"     Purpose:      The purpose of this study is to determine if disturbances in cytokines or factors of the     metabolic syndrome, can predict complications in pregnancy, birth, and the perinatal period     in pregnant women with type 2 diabetes or who are overweight. At the same time we, the     investigators at Rigshospitalet, want to determine if physical activity in the overweight     pregnant woman can influence these factors in a favourable way and, with that, improve the     progress of pregnancy and birth.   "
188947|NCT00311077|"     Primary objective        -  To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration          of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin          glulisine across healthy subjects in 4 different BMI-classes (lean, overweight,          moderately obese, severely obese), using the euglycemic clamp technique with the          Biostator™.      Secondary objective        -  To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous          administration of insulin glulisine in comparison to insulin lispro and to investigate          the safety and tolerability after subcutaneous administration of insulin glulisine in          comparison to insulin lispro.   "
188948|NCT00311090|"     The three purposes of this study are the following:        -  To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux          (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep          venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;        -  To compare the activities of idrabiotaparinux and idraparinux directly in blood during          and after a 6-month treatment;        -  To check the ability of avidin (SSR29261) to reverse the blood thinning activity of          idrabiotaparinux at the end of a 6-month treatment period.   "
188949|NCT00311103|"     Objectives: To assess the efficacy of an intervention program targeted to the elderly with     recent-onset disability of musculoskeletal origin (DIMS), and to perform its economic     evaluation.   "
188950|NCT00311116|"     The primary objective is to determine whether in children undergoing doxorubicin-containing     chemotherapy, if topical vitamin E, when compared to placebo, decreases an objective     measurement of oral mucositis.   "
188951|NCT00311129|"     The purpose of this study is to assess the antitumor effect and safety of fludarabine     phosphate tablet in combination with rituximab in patient with indolent lymphoma.   "
188952|NCT00311142|"     The development of regular sleep-wake cycle is an important factor of the newborn maturation     and it has influence on behavior .Factor that may influence the process of the maturation of     the sleep-wake cycle is the delivery mode.nd growing. These various states could be detected     and measured with actigraphy, using a wrist-watch like device that continuously measures and     records the subject's movements.The present study aims to compare vacuum delivery with     regular, elective and not elective caesarean sections. We hypothesize that the sleep of     vacuum-delivered newborns will be more fragmented then newborns in other delivery modes.   "
188953|NCT00311155|"     This study is to assess the safety and efficacy of an add-on treatment algorithm with     olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate     hypertension.   "
188954|NCT00311168|"     The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual     chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with     implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV     delay.   "
188955|NCT00311181|"     The objective of this study is to compare the ULV (Upper Limit of Vulnerability)/DFT     (Defibrillation Threshold) efficacy between the 2.5, 3.5 and 4.5 ms membrane time constant     based biphasic defibrillation waveforms. This comparison will result in identifying the     optimal membrane time constant when programming the tuned defibrillation waveform.   "
188956|NCT00311194|"     The purpose of this study is to determine whether extra education of patients with chronic     heart failure can reduce 6 months readmission rate to hospital.   "
188972|NCT00311402|"     Phase III study to compare the preventive effect of recurrent brain infarction and safety of     Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic     acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily   "
188973|NCT00311415|"     Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C     Conjugate Vaccine in healthy children   "
188958|NCT00311220|"     Tuberculosis is still the most common infectious disease in Taiwan. The infants in Taiwan     have been vaccinated at birth with BCG -Tokyo 171 strain since 1951. The BCG vaccination rate     is 97% among first grade students in a recent national survey. Even with such a high BCG     vaccination coverage, Taiwan still has a relatively high TB incidence rate. In 2004, there     were totally 16,784 newly diagnosed TB cases and the annual incidence was 74.11 per 100,000     population nationally. Nearly 70% of the incidence cases were men and 30.4% were women. The     mean age of incidence cases was 57.8 years old (median=63). 8,440(50.29%) patients were     elderly than 65 years old. The elderly men did not receive the BCG vaccination and were the     most important group to develop newly diagnosed tuberculosis and a special issue for the     national TB control program in Taiwan.      The tuberculin skin test (TST) is the only widely available method for detecting whether     people have an immunologic reactivity to mycobacterial antigens and identified as latent     tuberculosis infection (LTBI). Targeted tuberculin testing for latent TB infection is a very     important strategy to identify subjects with high risk to develop tuberculosis including     those who have recent infection with Mycobacterium tuberculosis or have clinical conditions     that associated with an increased risk for progression of LTBI to active TB but the     sensitivity was lower in elderly patients.      Quantiferon-TB gold test (QFT-RD1) is a new diagnostic test for latent tuberculosis and a     valuable alternative to skin testing. This whole-blood assay measures the production of IFN-      in whole blood upon stimulation by ESAT-6 and CFP-10 and allows distinction of latent M.     tuberculosis infection from BCG-induced reactivity. ESAT-6 and CFP-10 are deleted from BCG     Region 1 (RD1), not present in most nontuberculous mycobacteria and are highly specific     indicators of M. tuberculosis infection. Thus, the aim of this study was to estimate the     specificity and sensitivity of a whole blood IFN-γassay employing CFP-10 and ESAT-6, for the     detection of M. tuberculosis infection in a clustered high risk elderly population.      Changhwa Veterans Home is a government-expense veterans home with totally 519 residents in     2004.The inhabitants were all elderly people and lived in groups. , They did not receive BCG     vaccination and were the high risk group to develop endemic TB infection. The annual TB     incidence rate over there was 3,500 per 100,000 population.   "
188959|NCT00311233|"     Recurrent abdominal pain (RAP) is a common complaint in childhood. Identification of the     processes that maintain illness is important.      The purpose of this study is to get more knowledge about characteristics of children with     recurrent abdominal pain and their parents, and about the course of their pain. These results     may be important to identify children who need treatment.   "
188982|NCT00311532|"     The primary objective of this study is to estimate the incidence of new-onset valvulopathy,     determined by baseline and follow-up echocardiograms, in patients with Parkinson's Disease     who are receiving pergolide as second-line therapy.      The secondary objective of the study is to estimate the prevalence of valvulopathy, as     determined by baseline echocardiograms, among all patients who have Parkinson's Disease and     are being considered for pergolide as second-line therapy.   "
188960|NCT00311246|"     Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by     the buildup of immune-system (fights off infection in the body) cells in organs. These cells     form small groups called granulomas, which lead to inflammation of the surrounding tissue.     Sarcoidosis most commonly affects the lung and the lymph nodes (part of the immune system).     The signs usually include shortness of breath, fever, dry cough, and chest pain. Other signs     in many patients can include redness and painful lumps on the skin, reduced eyesight, joint     pain, and rarely, nervous system damage. Sarcoidosis commonly affects young and middle-aged     adults.      There are no approved therapies for the treatment of sarcoidosis. Corticosteroid (steroid     hormone) therapy is considered the standard treatment. Only limited benefit has been shown     when using corticosteroid therapy to ease lung symptoms or improve lung function in patients     with sarcoidosis. Also, the effects of other therapies (for example: methotrexate,     cyclophosphamide, anti-malarial drugs, thalidomide) and other immunosuppressants (drugs that     suppress a body's natural defense system [immune system]) which have been used in a small     number of patients are not well known and can cause long term problems.      The drug used in this study is called adalimumab. Adalimumab is FDA (Food and Drug     Administration) approved for patients with moderately to severely active rheumatoid     arthritis. However, adalimumab is not approved for the treatment of sarcoidosis. Adalimumab     is experimental in this study. The purpose of this study is to evaluate the safety and     effectiveness of adalimumab in the treatment of patients with sarcoidosis with pulmonary     (lung) involvement who show symptoms of the disease even though they are currently being     treated with medication.   "
188961|NCT00311259|"     The purpose of this study is to determine whether treatment with melatonin can reduce cell     damage and inflammation in connection with laparoscopic gall bladder surgery.   "
188962|NCT00311272|"     Dendritic cells loaded with tumor antigens induce cytotoxic T-cells which have been proved     capable of killing both melanoma and breast cancer cells. Melanoma and colorectal cancer     cells express some common antigens. Hence it is possible to use melanoma lysate to load the     dendritic cells with tumor antigens similar to the antigens expressed by the patients'     colorectal cancer cells.      The patient receives 10 vaccinations with 14 days between each. The parameters for effect are     changes in tumor/metastasis size measured with computed tomography (CT), decrease in serum     concentration of carcinoembryonic antigen (CEA), performance status measured by the World     Health Organization (WHO) criteria, and Quality of Life.   "
188963|NCT00311285|"     The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more     demanding because of the challenge of operating through small scars in the abdominal wall     without any tactile feedback depending only on the visual feedback on a monitor. The purpose     is to establish a model of how to measure mental and physical load in laparoscopy.   "
188964|NCT00311298|"     We propose a randomised trial among pulmonary TB patients, examined and treated as part of     the national TB control programme (WHO, 2003). The aim is to improve TB treatment outcome in     high TB and HIV burden countries. The overall objective of the proposed trial is to assess     the effect of nutritional support on TB treatment outcomes, and to assess the role of     diabetes on risk and severity of TB, and TB treatment outcomes. The study will be conducted     in Mwanza Tanzania. All patients will initially be examined for HIV and diabetes. A total of     500 found pulmonary TB smear-positive (PTB+) and HIV positive (HIV+) will be randomised to a     daily supplement of 1 versus 6 energy-protein bars throughout treatment, both with full     multi-micronutrient (MN) content. A total of 1500 found pulmonary TB smear-negative (PTB-,     irrespective of HIV status) and PTB+ and HIV negative (HIV-) will be randomised to 1 daily     energy-protein bar containing either low or high MN content.   "
188965|NCT00311311|"     The purpose of this study is to determine whether immunosuppression by tacrolimus,     mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate     mofetil, and prednisone affect the progression of atherosclerosis in renal transplant     recipients.   "
188966|NCT00311324|"     The purpose of this study it to determine if a culturally appropriate, church based     intervention for African Americans with type 2 diabetes, will lead to improved glycemic     (blood sugar) control.   "
188967|NCT00311337|"     Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and     tolerability, as well as the efficacy, of maintenance treatment with VELCADE (bortezomib) in     patients with multiple myeloma with detectable disease activity following tandem high-dose     chemotherapy and autologous SCT. The time from SCT to the initiation of VELCADE treatment     will be 3 to 6 months.   "
188968|NCT00311350|"     This is the first multiple-dose experience in humans with MOA-728 in an oral formulation.     This study will provide an assessment of the safety, tolerability, and pharmacokinetics (PK)     of MOA-728 following administration of ascending multiple oral doses to healthy subjects.   "
188977|NCT00311467|"     Multi-center, prospective randomised phase III study evaluating capecitabine in combination     with standard-immunotherapy versus standard-immunotherapy alone as first-line therapy in     patients with metastatic renal cell carcinoma.   "
188978|NCT00311480|"     The present study aims to evaluate safety and immunogenicity of two doses, administered three     weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1     influenza antigen, in non-elderly adult and elderly subjects.   "
188979|NCT00311493|"     The purpose of this study it is to evalutate the persistence of antibodies after a booster     immunisation with a TBE vaccine for adults   "
188980|NCT00311506|"     This is an observational study to be conducted at approximately 25 sites in the United     States. Approximately 25 subjects with severe obstructive CF lung disease (FVC <40%     predicted) will be enrolled.   "
188981|NCT00311519|"     The purpose of this research study to test the effectiveness of a study medication to     increase how fast a solution called lactated Ringer’s is absorbed when put under the skin     subcutaneously. The medication to be studied is an enzyme called hyaluronidase, and is a     human recombinant form of the enzyme. The drug company name for this medication is Hylenex.     Hylenex was currently an investigational medication at the initiation of the study, but     received FDA approval during the study. An investigational medication is a medication or     formulation of a medication that is not approved by the United States Food and Drug     Administration for use in this country but may be used in studies such as this one.   "
188984|NCT00311558|"     RATIONALE: Sodium stibogluconate may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Interferon may interfere with the growth of cancer cells.     Giving sodium stibogluconate together with interferon may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of sodium     stibogluconate when given together with interferon in treating patients with advanced solid     tumors, lymphoma, or myeloma.   "
188985|NCT00311571|"     Microgravity during space flight induces physiological changes that affect astronauts’ health     and performance. Space flight simulations such as prolonged bed rest can mimic some of these     changes and provide study conditions that are more accessible than during space flight. The     European Space Agency, ESA together with the French national space agency, CNES and the     Japanese national space agency, NASDA are performing extensive studies using long duration     bed rest.      Previous studies including several long and short term bed rest campaigns have yielded     significant medical data on the physiological changes induced by space flight. These data can     be used to study the effect of countermeasures, methods helping to prevent these     physiological changes.      The long duration bed rest, lasting 3 months undertakes a variety of investigations involving     28 subjects. This study focuses on countermeasures, studying the effect of a bone tissue     stabilisation medication and resistive exercises to determine their suitability for use     during long duration stays on ISS.      The physiological changes recorded during space flight and bed rest mimic those observed in     some diseases and in the aging process. Significant clinical applications are expected as a     direct result of this experiment and future equivalent studies.   "
188986|NCT00311584|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving irinotecan together with     temozolomide works in treating young patients with recurrent neuroblastoma.   "
188987|NCT00311597|"     RATIONALE: Extracranial stereotactic radiosurgery may be able to send x-rays directly to the     tumor and cause less damage to normal tissue.      PURPOSE: This phase I/II trial is studying the side effects and best dose of extracranial     stereotactic radiosurgery and to see how well it works in treating patients with solid     tumors.   "
188988|NCT00311610|"     RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.      PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients     with metastatic colorectal cancer.   "
188989|NCT00311623|"     RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This clinical trial is studying the best dose of sirolimus and to see how well it     works before surgery in treating patients with advanced localized prostate cancer.   "
188990|NCT00311636|"     RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may     prevent this from happening.      PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in     preventing early menopause in premenopausal women who are receiving chemotherapy for stage I,     stage II, or stage III breast cancer that has been removed by surgery.   "
189030|NCT00312156|"     The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use     of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of     NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves     children and adolescents with Type 1 Diabetes.   "
189116|NCT00314301|"     The purpose of this study is to compare movement variations before and after the loaded     training, with kinematics, kinetics, and electromyography, in children with spastic diplegia     and to further discuss mechanisms of the loaded training.   "
188991|NCT00311649|"     The purpose of this research is to study side effects and safety of a new H5N1 flu (bird flu)     vaccine and to look at how well people's immune systems make antibodies to fight infection     after they get the vaccine. Up to 300 healthy people who are working at Aventis Pasteur H5N1     virus vaccine production facility in Swiftwater, PA, during the flu season are being asked to     participate. It is important for vaccine production workers to receive the vaccine in order     to minimize the risk of this bird flu virus combining with the regular flu virus. Volunteers     in this study will have a medical screening, 2 vaccinations a month apart, 2 blood sample     collections (1 before and 1 after the vaccinations to compare), 5 clinic visits, and     follow-up over 6 months. They will also complete a diary card and to write down their     temperature once a day and any symptoms they have every day during the week after they get     their second shot. They will also be asked to write down any drugs or medicines they take.   "
188992|NCT00311662|"     Overall trial objectives:        -  Can treatment with tonabersat reduce the number of days with a migraine headache in          patients who suffer from frequent migraine attacks        -  How well tolerated is treatment with tonabersat      The study is based on the hypothesis that the unique mechanism of action of tonabersat will     inhibit some of the early events in the generation of migraine and so be effective as     prophylactic treatment   "
188993|NCT00311675|"     The purpose of this study is to see how antibodies (proteins that fight infection) are made     after you receive the new H5N1 flu vaccine. The new H5N1 vaccine will be given to 50 healthy     adult lab workers, aged 18 years and older. Subjects will receive two 90mcg injections (shots     in the arm) of the vaccine about 1 month apart. Subjects will maintain a memory aid to record     oral temperature and any response to the vaccine for 7 days after each immunization. Subjects     will be contacted by telephone 1 to 3 days after vaccination. They will return to the clinic     on Day 7. Blood will be drawn before each vaccination and on Days 56 and 180. Subjects may be     involved in the study for about 6 months. It is anticipated that the vaccine will provide     safe protection against influenza H5N1.   "
188994|NCT00311688|"     Interleukin-2 (IL-2) is a protein found naturally in the blood that helps boost the immune     system. The purpose of this study is to provide long-term treatment and monitoring of HIV     infected people enrolled in NIAID-funded studies investigating the use of laboratory-made     IL-2 for the treatment of HIV infection.   "
188995|NCT00311701|"     This retrospective study conducted in Canada and the US involves a chart review to assess the     safety of oseltamivir (Tamiflu®) compared to alternate antiviral therapy, amantidine or     rimantidine, administered to children less than 12 months of age with diagnosed or suspected     influenza. The objectives are to describe the frequency of neurological and all other adverse     events possibly related to administration of these antivirals in these infants. Investigators     will also compare frequency of adverse events at various doses of oseltamivir in these     children. Critical endpoints to be collected include frequency and severity of adverse     events, particularly those relating to central nervous system complications. A     sub-investigator will travel to each of the participating sites to collect data related to     each infant's health prior to becoming ill, health status at time of influenza diagnosis,     dosing regimen, reported neurological events post-dosing, and all reported adverse events     post-dosing.   "
188996|NCT00311714|"     This study will look at the safety, tolerability and what the body does to CS-8958 given to     40 healthy volunteers 18-55 years old. CS-8958 is a dry-powder investigational drug that is     breathed into the lungs through an inhaler device. The researchers will collect information     about any problems that volunteers have while taking the drug and about changes in blood     pressure and how the heart is working. Volunteers will have breathing tests, physical     examinations, and blood samples collected for laboratory tests. The researchers will also     look at how much of the medication travels throughout the body versus how much stays only in     the lungs. Doses of the medication will be tested at one level and then at higher and higher     levels after a safety committee reviews the safety and tolerability information on volunteers     prior to the next higher dose being given. Each volunteer will participate for up to 6 weeks     from initial screening to the follow up visit and spend 7 days in the clinic.   "
188997|NCT00311727|"     This study may determine whether laboratory studies of people's blood cells, who have     received vaccines against H5 influenza, or bird flu, will help to decide if the vaccines     are going to be prevent disease effectively. About 232 people, 18 years and older, enrolled     in the studies A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging     Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated     Influenza A/H5N1 Vaccine in Healthy Adults and in Healthy Elderly Adults will participate.     Participants may be involved in this study for about 14 months. Procedures may include blood     draws, physical exams, and medical history reviews.   "
188998|NCT00311740|"     The purpose of this study is to compare the effect of the fixed combination of     valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ     alone and whether the combination treatments are safe and well tolerated. The study aims to     establish a dose response relationship for both monotherapies and the combinations.      This study is being conducted in Japan.   "
188999|NCT00311753|"     Acutely ill immobilized patients are at a high risk for thromboembolic events including deep     venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular     weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This     study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH     certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.   "
189000|NCT00311766|"     The purpose of this study is to investigate a treatment to enhance the healing of acute and     chronic nonhealing cutaneous wounds, such as the erosions experienced by patients with     Epidermolysis Bullosa (EB), by the known activity of thymosin beta 4 (Tβ4). Funding Source -     FDA Office of Orphan Product Development (OOPD).   "
189001|NCT00311779|"     The primary objective of the study is to determine the safety and efficacy of different     strengths of Spinosad topical creme, as compared to a vehicle control, in subjects who have     been infested with at least a mild case of Pediculosis capitis (head lice).   "
189002|NCT00311792|"     The purpose is to determine if skills obtained by training in the laparoscopic virtual     reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as     improved score in a technical skills assessment.   "
189003|NCT00311805|"     The goal of the study is to determine the safety and possible effectiveness of various doses     of autologous (one's own) stem cells, delivered with a needle into the regions of the leg     with poor blood flow in patients with blocked leg arteries that results in claudication (pain     when walking). Stem cells are primitive cells produced by the bone marrow that can develop     into blood cells or other types of cells. In addition to determining whether this new     approach is safe, the diagnostic tests may offer preliminary insights into the usefulness of     this approach for treating intermittent claudication - the condition where areas in the leg     are lacking enough oxygen and blood flow to keep the leg muscle working well, causing pain     and cramping upon walking.      This study is a double-blind, randomized study to compare CD34-positive stem cells versus a     placebo agent (salt water solution known as normal saline). The patient will have a 3:1     chance of their stem cells versus the placebo. Regardless of a patient receiving placebo or     treatment, all patients will undergo all of the pre-treatment phases of this study, which     includes the stem cell mobilization and apheresis procedure.   "
189004|NCT00311818|"     Primary objective:        -  To compare efficacy of oral antidiabetics (OAD) combination therapy with either HOE901          insulin analogue once daily or Lispro insulin analogue at mealtime in terms of change in          HbA1c (baseline to endpoint).      Secondary objectives:        -  To compare the OAD combination therapy with either HOE901 insulin analogue once daily or          Lispro insulin analogue at mealtime in terms of efficacy and safety.   "
189005|NCT00311831|"     The purpose of this study is to determine whether the caregivers of children presenting to     the emergency department (ED) with acute gastroenteritis who receive extensive     gastroenteritis education (standard education plus home nursing visit) will improve their     gastroenteritis knowledge more than those who receive standard education (an information     sheet) in the emergency department.   "
189006|NCT00311844|"     This study was a double-blind, placebo-controlled, cross-over, single-center study of     desloratadine 5 mg or placebo in subjects 18 years of age or older with a history of seasonal     allergic rhinoconjunctivitis. This study was performed to examine the effects of     desloratadine compared with placebo, on the signs and symptoms of allergic conjunctivitis     induced by direct conjunctival challenges with a previously identified sensitizing antigen,     in the eyes of a subject known to be sensitive to the antigen.   "
189007|NCT00311857|"     GERT is a one-armed single-center phase I/II trial. In a first step, dose-escalation of TMZ     from 50 mg/m2 to 75mg/m2 together with radiotherapy and cetuximab will be performed. Should     safety be proven, the phase II trial will be initiated with the standard dose of 75mg/m2 of     TMZ. Cetuximab will be applied in the standard application dose of 400mg/m2 in week 1,     thereafter at a dose of 250mg/m2 weekly. A total of 46 patients will be included into this     phase I/II trial.      Primary endpoints are feasibility and toxicity, secondary endpoints are overall and     progression-free survival. An interim analysis will be performed after inclusion of 15     patients into the main study. Patients’ enrolment will be performed over a period of 2 years.     The observation time will end 2 years after inclusion of the last patient.   "
189008|NCT00311870|"     The aim of the study was to compare the renoprotective effect of a long acting calcium     antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type     1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to     treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and     urinary excretion of albumin were measured every 6 months   "
189009|NCT00311883|"     Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis     before and after a 4 week course of oral hydroxychloroquine.   "
189010|NCT00311896|"     The purpose of this study is to evaluate the efficacy and safety of the subcutaneous     administration for 45 days of Bemiparin (3,500 UI/day) in cancer patients with a CVC, to     prevent CVC-related deep venous thrombosis (CVC-DVT)   "
189011|NCT00311909|"     The purpose of this study is to determine whether deep brain stimulation is effective at     reducing tic frequency and severity in adults with Tourette syndrome.   "
189012|NCT00311922|"     The aim of this research will be to perform a randomized controlled trial (RCT) of a new     diabetes educational intervention that teaches self-management skills that compensate for     poor numeracy skills among a sample of patients with diabetes and low numeracy.   "
189013|NCT00311935|"     This study will determine whether laparoscopic and open hernia repair have the same     recurrence and complication rates in the under 60yr old age group. The overall financial     costs of each repair will also be compared.   "
189014|NCT00311948|"     The purpose of this study is to look at both the clinicians' ability to reach out to the teen     smokers and to evaluate the efficacy of providing tobacco cessation support using a proactive     telephone quitline combined with an interactive Web-based program for teens within a managed     care environment.   "
189015|NCT00311961|"     Treatment with systemic corticosteroids for acute exacerbations of COPD results in the     improvement of clinical outcomes. The optimal route of administration has not been rigorously     studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many     hospitals. Oral administration is more convenient, though, because there is no need for     intravenous access, less personnel is required for starting and monitoring therapy, and     material costs are smaller.      The investigators hypothesized that oral administration is not inferior to intravenous     administration of prednisolone in the treatment of patients hospitalized for an acute     exacerbation of COPD.   "
189016|NCT00311974|"     We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine     leads to the activation of the sympathetic nervous system in healthy individuals.   "
189059|NCT00313521|"     RATIONALE: Drugs used in chemotherapy, such as thiotepa, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and     radiation therapy after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well thiotepa works together with radiation     therapy in treating young patients with newly diagnosed malignant brain tumors.   "
189060|NCT00313534|"     RATIONALE: Nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of     nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer.   "
189017|NCT00311987|"     The natural thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to have a     cholesterol-lowering effect. Their pharmacologic use for this purpose is limited, however, by     their actions on other organs, including the heart, bone, and brain, where there can be side     effects of excessive thyroid hormone action. 3,5-diiodothyropropionic acid (DITPA) is a     thyroid hormone analog with relative selectivity for a form of the thyroid hormone receptor     expressed in the liver, where it regulates several aspects of lipid metabolism, including the     clearance of low-density lipoprotein (LDL) cholesterol.      This study is designed to determine whether DITPA is safe and effective in achieving LDL     cholesterol levels that are consistent with the National Cholesterol Education Program Adult     Treatment Panel III (NCEP ATP III) guidelines in patients who have not achieved those levels     on conventional therapy, due to drug-resistant disease, drug intolerance, or both.      This is a single-center, randomized, double-blind, placebo-controlled study. Following a     4-week Pre-Randomization Phase with dietary counseling and a 2-week placebo run-in, eligible     patients will be randomized (1:1:1) to receive DITPA (90 mg/day, 180 mg/day), or placebo for     a total treatment duration of 12 weeks.      Sixty (60) patients will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (i.e., 20     patients per treatment group):        -  DITPA at 90 mg/day (45 mg twice a day [BID] taken orally)        -  DITPA at 180 mg/day (90 mg BID taken orally)        -  Placebo (BID taken orally)      Those patients randomized to receive DITPA at 90 mg/day will receive 45 mg/day for the first     2 weeks, followed by 90 mg/day for 10 weeks.      Those patients randomized to receive DITPA at 180 mg/day will receive 45 mg/day for the first     2 weeks, followed by 90 mg/day for the next 2 weeks, and then 180 mg/day for 8 weeks.   "
189018|NCT00312000|"     Primary objective:To assess the efficacy, defined as overall survival, of sequential versus     combination chemotherapy for advanced colorectal cancer (CRC).      Methodology Open, randomised multicenter phase III study. Randomisation by centre will be     centralized. 820 patiënts with histologically proven advanced CRC; not amenable to curative     surgery. Measurable or evaluable disease. Age 18 years and above. WHO performance status 0-2.      Test products:      Arm A: First line: capecitabine capecitabine 1250 mg/m2 orally b.i.d. on day 1-14 (q3),until     progression or unacceptable toxicity. Second line: irinotecan 350 mg/m2 IV infusion on day 1     (q3),until progression or unacceptable toxicity. Third line: oxaliplatin 130 mg/m2 IV     infusion on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3). Arm B: First     line: irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 and capecitabine 1000 mg/m2     orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity. Second line:     oxaliplatin 130 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3),     until progression or unacceptable toxicity.      Patients will be followed by CT-scan every 9 weeks for response while on treatment, or at any     other moment when progression is suspected. After cessation of chemotherapy, patients will be     followed every 3 months until death. Clinical and laboratory toxicity/symptomatology will be     graded according to NCI common criteria.   "
189020|NCT00312026|"     This is a Phase IV randomized, double-blind, placebo-controlled study to evaluate the safety     and efficacy of SC efalizumab in adult patients (18 years of age and older) with chronic     moderate to severe plaque psoriasis involving the hands and/or feet who have had no previous     exposure to efalizumab. The study will consist of a screening period, a treatment period, and     an observation period.   "
189021|NCT00312039|"     HIV-1 infected patients receiving long-term therapy with lamivudine or emtricitabine     (nucleoside reverse transcriptase inhibitors [NRTIs]) are at risk for the development of a     mutation at position M184 on the HIV reverse transcriptase gene. This mutation confers     resistance to both drugs (> 100 fold increase in IC50).      In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation     show only a 10-fold increase in IC50 as compared to wild type HIV-1. Achillion     Pharmaceutical's intention is to demonstrate that 10 mg of elvucitabine, administered once     per day for 14 days with continued background anti-HIV-1 medications, will demonstrate a fall     in HIV-1 RNA plasma levels, as compared to baseline. The data from this study will guide     dosing in future long-term studies in HIV-1 infected patients with the M184V mutation.   "
189022|NCT00312052|"     The primary purpose of this study is to assess the safety and tolerability of E5555 in     subjects with coronary artery disease.   "
189023|NCT00312065|"     The purpose of this study is to examine the need for reflective heat shield covers over the     temperature probes applied to the skin of newborn babies who are being nursed under a radiant     warmer.   "
189024|NCT00312078|"     The purpose of this study is to determine whether a special yogurt can improve performance on     certain tests of intelligence and decrease liver inflammation in patients with cirrhosis.   "
189025|NCT00312091|"     The purpose of this study is to compare the blood levels, absorption, and breakdown of     lamivudine (3TC), nevirapine (NVP), and stavudine (d4T) in a fixed-dose tablet to that of the     individual liquid formulations of the same anti-HIV drugs in HIV infected Thai children.   "
189026|NCT00312104|"     The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of     insulin detemir twice daily combined with mealtime insulin aspart against that of insulin     glargine once daily combined with mealtime insulin aspart. The trial involves patients with     Type 1 Diabetes.   "
189027|NCT00312117|"     Contrast nephropathy (CN) is a common cause of renal failure associated with prolonged     hospitalization, significant morbidity/mortality, and cost. In addition, these patients may     require temporary or permanent hemodialysis which, in turn, is associated with further     morbidity, mortality, and cost. CN has been reported to account for 10% of hospital acquired     renal failure. In recent years, studies have investigated preventive therapies with mixed     results. Fenoldopam was found to be ineffective in a large randomized trial. Dopamine has     been shown to be ineffective as a preventive strategy. Hemofiltration has been shown to be     beneficial (New England Journal of Medicine [NEJM] 2003) but is costly and not practical.     Mucomyst has shown mixed results. The single strategy which most would agree as being     beneficial remains hydration, most commonly with intravenous 0.9% normal saline. Most     recently, sodium bicarbonate has been shown to be beneficial in a small randomized trial     (n=119). It is clear that the most cost effective strategies for treatment of CN should be     aimed at prevention.      The general question is: Is a sodium bicarbonate solution more efficacious in preventing     contrast nephropathy compared to normal saline? The general hypothesis is that sodium     bicarbonate will be more efficacious.   "
189028|NCT00312130|"     This is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase     insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and     elevated levels of fasting glucose.   "
189029|NCT00312143|"     This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in     combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney     transplant recipients.   "
189031|NCT00312169|"     This is a multicenter, open-label, non-randomized, dual-arm pilot study to investigate the     prevalence of the reverse transcriptase (RT) resistance mutations, K65R/x or L74V/x, in HIV-1     plasma from subjects experiencing confirmed first-time incomplete virologic suppression     during treatment with an initial antiretroviral (ARV) regimen consisting of at least 12 weeks     of TDF or ABC + emtricitabine (FTC) or lamivudine (3TC) + non-nucleoside reverse     transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Subjects will be followed until a     substantial loss of virologic or immunologic control requires a treatment switch. Confirmed     first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA     response < 400 copies/mL, and subsequent virologic rebound > 400 copies/mL measured at two     consecutive times.      Subjects will have a screening genotype to establish adherence to their non-suppressive TDF-     or ABC-containing regimen by the presence of M184V (or other treatment-related primary)     mutation and to demonstrate that the evolution of treatment-emergent RT mutations can be     characterized.      Twenty subjects (a maximum of 10 per arm) will be enrolled at 10-20 United States (U.S.)     sites. If fewer than 20 subjects can be enrolled, the study may be discontinued early by the     sponsor. Equal numbers of subjects on Arm A versus Arm B will be a goal.   "
189032|NCT00312182|"     To assess if nelfinavir has any clinically meaninful effect on cardiac function, namely ECG     evaluation   "
189033|NCT00312195|"     The objective of this study is to demonstrate the effectiveness and tolerability of the     buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal     system in subjects with chronic nonmalignant pain syndromes currently controlled by oral     opioids. The double-blind treatment intervention duration is 2 weeks during which time     supplemental analgesic medication (acetaminophen) will be provided to all subjects in     addition to study drug.   "
189034|NCT00312208|"     Primary objective :        -  To compare disease-free survival after treatment with docetaxel in combination with          doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by          docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive          axillary lymph nodes.      Secondary objectives :        -  To compare toxicity and quality of life between the 2 above-mentioned arms.        -  To evaluate pathologic and molecular markers for predicting efficacy.   "
189146|NCT00314691|"     After extraction of the cell-free DNA circulating in maternal plasma, we aim at developing     new techniques for fetal DNA enrichment to perform fetal gender determination, and indirect     diagnosis of inherited diseases like Cystic Fibrosis, Huntington Disease, Myotonic Dystrophy,     B-Thalassaemia...   "
189035|NCT00312221|"     The objective of this study is to demonstrate the effectiveness and tolerability of the     buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal     system (5 mg) and oxycodone immediate release in subjects with moderate to severe     osteoarthritis pain currently treated with oral opioids. The double-blind treatment     intervention duration is 12 weeks during which time supplemental analgesic medication     (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in     addition to study drug.   "
189036|NCT00313222|"     The present trial investigates a possible use of oral bosentan, which is currently approved     for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering     from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i)     peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary     hypertension after pulmonary endarterectomy.   "
189037|NCT00313235|"     The purpose of this study is to test a combined treatment using cyclophosphamide and a novel     dendritic cell vaccine in patients with Stage IV melanoma.   "
189038|NCT00313248|"     The purpose of this study is to evaluate whether treatment with a new drug called     ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop     tumor growth.   "
189039|NCT00313261|"     The purpose of this study is to evaluate the safety and antiviral activity of clevudine 30 mg     QD for treatment of longer period (24 weeks) in patients chronically infected with HBV.   "
189040|NCT00313274|"     The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine     (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative   "
189041|NCT00313287|"     The purpose of this study is to determine safety and efficacy of 30 mg daily dose of     clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.   "
189042|NCT00313300|"     The purpose of this clinical research study is to determine whether apixaban will be safe in     people who have recently had unstable angina or a heart attack.   "
189043|NCT00313313|"     The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe     and works better than increasing the amount of sulfonylurea a patient takes   "
189044|NCT00313326|"     This is a comparative study of duration of respiratory weaning between adaptive support     ventilation and succession of controlled ventilation then spontaneous ventilation for     patients after surgery.   "
189045|NCT00313339|"     Following a Heart attack the acute loss of heart muscle cells results in a cascade of events     causing an immediate decrease in cardiac function that has the potential to persist long     term. Despite revascularization of the infarct related artery circulation and appropriate     medical management to minimize the stresses on the heart walls, a significant percentage of     patients experience permanent cardiac dysfunction and consequently remain at an increased     life-time risk of experiencing adverse cardiac events, including death.      There is a great potential for stem cell therapy, using a variety of cell precursors     (particularly hematopoietic,)to contribute to new blood vessel formation (and possibly     limited heart muscle formation) and muscle preservation in the myocardial infarct zone. The     administration of cells via an infusion through the infarct related artery appears to be     feasible and result in a clinical effect in some studies.      Therefore, we propose to evaluate the safety and efficacy of a CD34+ selected stem cell     product (AMR-001), administered through the infarct related coronary artery 6 to 9 days after     successful infarct related artery stent placement.      The primary objective of the study is to determine the feasibility and safety of     prospectively identifying patients at risk for clinically significant cardiac dysfunction     following a myocardial infarction and the ability to isolate and infuse via the affected     coronary circulation an autologous bone marrow derived CD34+ cell product at four dose     levels.      The secondary objective of the study is to assess the effect on cardiac function and infarct     region perfusion. A concurrent patient group meeting eligibility but not receiving CD34+     cells will be evaluated similar to the treated group to assess the rate of significant     spontaneous improvement in cardiac function without CD34+cell infusion.   "
189046|NCT00313352|"     The purpose of this chart review study is to examine the effects of beta -adrenergic blocking     agents on systemic ventricular dimensions, systemic atrioventricular valve function and     exercise tolerance in patients with transposition of the great arteries (TGA) and systemic     ventricular dysfunction.   "
189061|NCT00313547|"     The purpose of this study is to compare the impact of two blood pressure lowering treatments     (high dose quinapril versus low dose quinapril plus amlodipine) on variations in heart rate     over 24 hours.   "
189047|NCT00313365|"     Joint spaces are aseptic areas, meaning that they do not contain microorganisms. Any injury     to the joint space could cause the entry of microorganisms, with the potential to cause     infection. Septic arthritis refers to the infection of a joint space with microorganisms,     usually bacteria. This invasion initiates a process of inflammation and causes irreversible     damage to a joint cavity. Patients typically present with pain, swelling, decreased motion,     and inability to use the joint. When bacteria enter a joint space, the host immune system     responds by concentrating inflammatory cells within the joint. While inflammatory cells serve     to eliminate the bacteria, they also produce substances that not only attack bacteria but     also could destroy the joint space. These substances are called enzymes, and they could     damage the cartilage (translucent fairly elastic tissue around the joint) and adjacent bone     in the process. Because cartilage has a poor ability to cure itself, this process may lead to     irreversible damage and chronic joint dysfunction. Studies have found that signs of early     joint damage can be found within hours following joint infection. This is true even if     antibiotic therapy (medicine to fight the infection) is started within 24 hours of infection.     Also, delay in treatment has been related to poor outcome. However, the best method of     treating septic arthritis has yet to be determined. Currently, there are two accepted ways     for treating septic arthritis: serial needle aspiration (introducing a needle in the joint to     aspirate the inflammatory liquid), and surgical lavage (opening and cleaning the joint space     in the OR under anesthesia). Antibiotics are also used with these two forms of treatment.     Supporters of surgery believe that the most dependable method of eliminating bacteria from a     joint space is through arthrotomy (opening the joint with a surgical incision) and lavage     (irrigation of the joint with copious saline solution) .Promoters of serial needle aspiration     support this method because it is quick, does not require opening the joint space, and can be     performed without anesthesia.At present, there are no conclusive studies comparing the two     techniques. Hopefully, this study will help delineate the best course of management.   "
189048|NCT00313378|"     Lung surgery under thoracotomy is known to induce long-term pain which can be considered as     neuropathic in many patients concerned [1,2]. The suspected origin of neuropathy is a direct     traumatism of intercostal nerve(s) [3]. Among the possible preventive treatments that can be     administered during the initial aggression, ketamine [4,5] appears as the easiest to use, as     it is already commonly administered intra and postoperatively for improvement of analgesia     [6].   "
189049|NCT00313391|"     The purpose of this study is to determine if Risperdal Consta will affect the healthcare     utilization costs in chronically ill schizophrenic patients with multiple admissions to the     psychiatric hospital compared to the previous utilization costs under standard oral treatment     of any atypical antipsychotic. We hypothesize that higher Risperdal Consta acquisition costs     can be offset by reduction in total medical utilization costs, such as hospitalizations, ER     visits, unscheduled outpatient visits or incarcerations due to worsening of psychotic     symptoms.   "
189147|NCT00314704|"     The purpose of this study is to compare the efficacy of dopamine and norepinephrine, two     commonly used vasopressor agents, in the treatment of shock.   "
189050|NCT00313404|"     Norwalk virus and related Norwalk-like viruses are the most common cause of outbreaks of     stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United     States. These viruses are sometimes found in drinking water, ice, shellfish and in other     foods. They can be spread easily from contact with water, food, objects or hands that have     even small amounts of feces from someone who was sick.      The purpose of this research study is to see how long Norwalk virus can survive in water and     still be able to cause sickness. When this is determined the researchers will be able to     recommend risk levels for norovirus contaminated waters. Another purpose for this study is to     see how a person's body's immune cells respond to Norwalk virus in the body. During this     study volunteers will receive a dose of Norwalk virus in water that may make them sick.   "
189051|NCT00313417|"     Creatine as a new therapeutic strategy in depression:      A double-blind, parallel, randomized, add-on clinical trial of creatine versus placebo added     to antidepressant treatment of patients with major depressive episode.   "
189052|NCT00313430|"     The investigators want to test the hypothesis that patients with chronic renal disease have a     poorer ability to preserve water after being thirsty and a poorer ability to excrete water     after a load of fluid. They presume that these abilities become poorer when renal     insufficiency progresses. The investigators further hypothesize that patients with     hypertension also have a decreased ability to concentrate and dilute urine.   "
189053|NCT00313443|"     The objective of this study is to determine if concentrations of amiodarone in fat tissue     increases constantly over time during chronic treatment with this drug, and if blood     concentrations reflect accurately the concentrations in fat tissue or not. This is because     excessive concentrations of this drug in tissues can produce adverse effects.   "
189054|NCT00313456|"     This is a single-center, open-label (sequential-group dose-escalation dose-finding) phase I     study of satraplatin and docetaxel in patients who have received prior chemotherapy regimens.     Once the MTD is determined, an additional 6 patients, all with chemotherapy-naïve HRPC, will     be enrolled. Once a recommended dose(s) (RD(s)) for phase 2 studies has/have been determined,     6 additional patients with chemotherapy-naïve HRPC will be enrolled at the RD to further     evaluate safety and efficacy.   "
189055|NCT00313469|"     We propose to study the pharmacokinetic (PK) and pharmacodynamic (PD) components of the     response to fluindione, the main oral anticoagulant used in France, in patients over 80.      We expect to gain a better understanding of the role of age, nutritional status, genetic     factors and drug interactions in the variability of the response to fluindione.   "
189056|NCT00313482|"     This is a Phase II, open-label study in male patients with metastatic HRPC.      Each cycle will be 21 days (3 weeks). Patients will receive the following drugs:        -  Docetaxel 75 mg/m2 IV given over 1 hour on Day 1.        -  Prednisone 5 mg orally twice daily beginning on Day 1 and continuing until disease          progression.        -  Sargramostim 250 mcg/m2 SC on Days 2-15 of each cycle. Patients will be evaluated every          4 cycles (12 weeks) for response using RECIST criteria. PSA response will be evaluated          according to the National Cancer Institute (NCI) PSA Working Group Criteria. To evaluate          the safety of this drug combination, patients will be evaluated at each clinic visit for          adverse events. Toxicities will be assessed per National Cancer Institute (NCI) CTCAE          Version 3.0.      Those patients achieving stable disease or better will continue therapy. Those patients     experiencing progressive disease will be taken off study.      Patients will receive a maximum of 10 cycles of treatment.   "
189057|NCT00313495|"     The purpose of this study is to collect prospective data from individuals who are part of a     Huntington Disease (HD) family, in order to relate phenotypes between individuals and     families with each other and genetic factors in order to learn more about HD, develop     potential treatments for HD, and to plan for future research studies of experimental drugs     aimed at slowing or postponing the onset and progression of HD.   "
189058|NCT00313508|"     This is a randomized, controlled, multicenter, dose-escalation study of fludarabine. Patients     are randomized to 1 of 2 treatment arms.      The purpose of this study is to find out what side effects are caused in this study and     whether Fludarabine with the dendritic cell vaccine (DC vaccine) can increase the ability of     the immune system to recognize melanoma.   "
189062|NCT00313560|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed. Drugs used in chemotherapy, such as     capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving erlotinib together with combination     chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after     surgery.      PURPOSE: This randomized phase II trial is studying how well giving erlotinib before and     after surgery together with combination chemotherapy and radiation therapy works in treating     patients with stage I or stage II pancreatic cancer that can be removed by surgery.   "
189063|NCT00313573|"     RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer.     It is not yet known whether telemedicine is more effective than standard care in treating     depression and/or pain caused by cancer.      PURPOSE: This phase III randomized clinical trial is studying telemedicine to see how well it     works compared to standard care in treating patients with depression and/or pain caused by     cancer.   "
189064|NCT00313586|"     This randomized phase II trial studies azacitidine with or without entinostat to see how well     they work compared to azacitidine alone in treating patients with myelodysplastic syndromes,     chronic myelomonocytic leukemia, or acute myeloid leukemia. Drugs used in chemotherapy, such     as azacitidine, work in different ways to stop the growth of cancer cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Entinostat may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Giving azacitidine together with entinostat may work better in treating patients with     myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.   "
189148|NCT00314717|"     The purpose of the study is to see if a low glycemic index diet will reduce blood sugar     levels in pregnant women with high blood sugar levels.   "
189065|NCT00313599|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Lapatinib may help paclitaxel work better by making tumor cells more sensitive to the drug.     Lapatinib may also stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Giving lapatinib together with paclitaxel may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when     given together with paclitaxel in treating patients with advanced solid tumors.   "
189066|NCT00313612|"     This phase II trial is studying how well giving oxaliplatin together with topotecan works in     treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian     tube cancer. Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.   "
189067|NCT00313625|"     RATIONALE: Giving chemotherapy, such as melphalan and busulfan, before a donor peripheral     blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells     from a donor are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells     from a donor can make an immune response against the body's normal cells. Giving tacrolimus     and methotrexate before or after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving melphalan together with busulfan     followed by donor peripheral stem cell transplant, tacrolimus, and methotrexate works in     treating patients with multiple myeloma.   "
189068|NCT00313677|"     The purpose of the study is to describe the early signs and symptoms of the     dystroglycanopathies, and to gather information that will be required for future clinical     trials.   "
189069|NCT00313690|"     -  The purpose of the phase I portion of the study is to determine the safety and          feasibility of neoadjuvant bortezomib in combination with docetaxel and cisplatin          followed by surgery in early stage non-small cell lung cancer, via a multi-cohort dose          escalation trial.        -  The phase II portion of the study will look at the clinical response rate and the          pathology response rate. Other purposes are to look at surgical morbidity, mortality and          respectability rates. Molecular correlates of response and survival to this neoadjuvant          regimen will be explored.   "
189070|NCT00313703|"     The purpose of this study is to determine how often headaches recur and to learn how to     predict continued suffering from headache after emergency department discharge.   "
189071|NCT00313716|"     The purpose of this study is to determine the effect of early administration of recombinant     human erythropoietin on long-term neurological outcome after severe traumatic brain injury.   "
189072|NCT00313729|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients     with supratentorial low-grade glioma.   "
189073|NCT00313742|"     This trial is conducted in Europe. The aim of this research is to assess the impact of three     basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes     when performing physical exercise.   "
189074|NCT00313755|"     The purpose of this study is to determine whether a new colonoscopic viewing technique called     narrow band imaging (NBI)can help doctors detect more patients with at least one     pre-cancerous area than conventional colonoscopy using white light alone in patients with     genetically inherited high risk for bowel cancer (HNPCC).   "
189075|NCT00313768|"     To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel,     carboplatin and bevacizumab as first-line treatment in patients with locally advanced or     metastatic nonsquamous non-small cell lung cancer   "
189076|NCT00313781|"     To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of     prostate cancer that is refractory to hormone therapy   "
189077|NCT00313794|"     This study is for patients with metastatic adenocarcinoma arising from the colon or rectum     who have received treatment(s) for metastatic disease with subsequent disease progression.     Patients who are intolerant to treatment(s) are also included. This is a study for good     performance status colorectal cancer patients who have exhausted standard therapy options.   "
189078|NCT00313807|"     Exposure to radiographic contrast dye during coronary angiography is well known to cause     either transient decreases in renal function or acute renal failure. Although the overall     incidence is low, acute renal failure occurs most frequently in patients with both diabetes     and chronic renal failure where the average reported incidence is upwards of 20%. The     etiology of contrast-induced nephropathy is related to acute decline in renal blood flow     following dye exposure resulting in ischemic injury at the level of the medulla. The     development of acute renal failure following radiocontrast dye administration is significant     because it contributes to morbidity and mortality in patients at risk.      The administration of amino acids, either through intravenous infusion or a protein meal,     results in a substantial increase in renal plasma flow (RPF) and glomerular filtration rate     (GFR). In both healthy subjects and in those with chronic renal failure, an amino acid     infusion produces a 20% rise in GFR and effective RPF.      We hypothesize that the 20% rise in effective RPF and GFR following an amino acid infusion     will counteract the radiocontrast dye-induced vasoconstriction and reduce the renal toxicity     of contrast medium in a group of high-risk patients.   "
189079|NCT00313820|"     Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with     central post stroke pain (CPSP)   "
189080|NCT00313833|"     This pilot study was designed to evaluate the effectiveness and tolerability of the     buprenorphine transdermal system versus placebo on health outcomes in elderly residents in     supervised living environments. The treatment intervention duration is 42 days during which     time supplemental analgesic medication (usual analgesic care) will be provided to all     subjects in addition to study drug.   "
189149|NCT00314730|"     This study evaluates the usability of personal digital assistants (PDAs) by nurses for     collecting, utilizing and communicating patient health information, and the feasibility of     using PDAs to increase nurses' access to and utilization of best-practice guidelines.   "
189081|NCT00313846|"     The objective of this study is to demonstrate the effectiveness and tolerability of the     buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal     system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently     treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during     which time supplemental analgesic medication (acetaminophen) will be provided to all subjects     in addition to study drug.   "
189082|NCT00313859|"     This trial is designed to assess the tolerability and efficacy of simvastatin plus FOLFIRI     (irinotecan, 5-FU, leucovorin) in metastatic colorectal cancer patients.   "
189083|NCT00313872|"     To assess the optimal sequence of the palliative chemotherapy regimen (DP --> FOLFIRI vs     FOLFIRI --> DP) in metastatic gastric cancer patients.   "
189084|NCT00313885|"     Fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing     sleep. Additionally, studies have reported that sleep problems, pain and mood disturbances     are associated in patients with fibromyalgia. By improving the quality of sleep, complaints     of poor and unrefreshing sleep, fatigue, pain, which are among the main components of this     chronic pain disorder may be improved.   "
189085|NCT00313898|"     In clinical practice it is quite common to have sexually active male patients with     mild/normal erectile function that are not satisfied with their sexual function. The aim of     this study is to evaluate the effect of sildenafil on the quality of sexual function in this     group of patients.      The endpoint of this study is to define another, different group of patients that may respond     positively to treatment with sildenafil.   "
189086|NCT00313911|"     To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence     rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the     three vaccinations at 2, 4, and 6 months of age for each subject.      To evaluate the overall safety in terms of:      Any solicited adverse reactions in the first 7 days after each injection, Any adverse events     and reactions in the first 30 days after each injection, Any serious adverse events during     the trial.      Immunogenicity:      To document the immune response to Hepatitis B antigen of the three batches of the     investigational DTaP-IPV-HB-PRP~T vaccine.   "
189087|NCT00313924|"     OAB is a widespread medical problem affecting 6- 30% of the population (both sexes and all     age groups) in Europe1 and 16%2-18%3 of the US and Canadian population. Nevertheless only a     small proportion of this group turns to seek medical help. Once treated, evaluation of     treatment outcome is problematic since outcome measures for success vary widely (i.e.     improvement in number of incontinence episodes, number of urge episodes, change in frequency     and nocturia etc) but do not include measures of patient reported outcomes.      The OAB Assessment Tool is a self-administered questionnaire (8-question self–filled survey)     primarily intended to identify patients with symptoms of OAB. The same comparable information     could be obtained after a certain treatment period, thus providing accurate and precise     measures of success. It could also offer insight to the changes of the different parameters     that make up the problem. Due to its ease of administration and its high specificity in     assessing OAB, the OAB Assessment Tool seems to be optimal for this objective.   "
189088|NCT00313937|"     Primary objective:      To compare metabolic control as measured by Blood Glucose (BG) upon arising from bed (7:00 am     - 12:00 pm) in type 1 Diabetes mellitus patients who skip the morning meal during treatment     with MDI basal/bolus insulin: Difference of change of blood glucose between 7:00 am and 11:00     am between patients on Insulin glargine and NPH insulin.      Secondary objective:      To perform an evaluation between the two patient groups for BG (10:00 pm and 12:00 pm) as     well as for serum insulin, free fatty acid levels and β-hydroxybutyrate (7:00 am - 12:00 pm).   "
189089|NCT00313950|"     The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months     Turkish children and check if the administration of the MMR trivalent vaccine on the same day     but at different site will interfere on immunogenicity for the four valences Hepatitis A,     Measles, Mumps, and Rubella.   "
189090|NCT00313963|"     The purpose of this study is to determine if intravenous magnesium sulfate treatment is     effective in reducing the length of stay and pain in children with sickle cell disease     suffering an acute vaso-occlusive episode.   "
189091|NCT00313976|"     The purpose of the study is to evaluate if the higher dose can give greater efficacy without     negative impact on the adverse event profile for patients with early secondary progressive     Multiple Sclerosis (SPMS).   "
189092|NCT00313989|"     Follow up of implants with patients receiving radiotherapy for buccopharyngeal oncology.     Implants will be placed 6 weeks before start of the radiotherapy or at least 3 months after     the end of the radiotherapy   "
189093|NCT00314002|"     Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With     Massive Pulmonary Embolism      Study Population: Patients >/= 18 years of age with massive pulmonary embolism suitable for     mechanical thrombectomy with Aspirex 11F.      Treatment: Aspirex 11F assisted thrombectomy      _________      The study was terminated early. After having treated seven (7) patients, it was decided in     April 2007 that the handling characteristics of the test device should be upgraded before     continuing the trial as planned. Therefore, the study was long-term interrupted and finally     terminated early. This decision was made by the sponsor in full accordance with the principal     investigator. Further studies shall be conducted to show effectiveness and safety of the     Aspirex PE catheter thrombectomy device.      _________      Primary Endpoints:        1. Thrombectomy with the Aspirex catheter device is associated with an immediate decrease          in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP).        2. The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and          untreated cardiovascular structures.      Secondary Endpoints:        1. Thrombectomy with the Aspirex catheter device is associated with improved flow in the          treated main and lobar pulmonary arteries as assessed by the angiographic Miller index.        2. There will be no significant mechanical haemolysis as assessed by plasma free          haemoglobin levels.        3. In-hospital mortality will not exceed 20%.      Study Design: A prospective international multicenter non-randomized registry assessing the     safety and efficacy of the Aspirex 11F mechanical thrombectomy device.      Sample Size: Maximum of 50 patients      Inclusion Criteria:        -  Patients with massive pulmonary embolism and cardiogenic shock with failed thrombolysis          or at least contraindication for lysis.      Exclusion Criteria:        -  Systemic embolism in the presence of an arterial septal defect or patent foramen ovale.        -  Free floating right heart thrombi, left heart thrombi.        -  Life expectancy, due to underlying disease, less than one month.   "
189094|NCT00314015|"     Evaluation of the success rate of immediately loaded implants based on:        -  condition of the gingiva        -  stability of the implants        -  evaluation of the RXs        -  questionnaires   "
189095|NCT00314028|"     This study will test the effectiveness of a brief clinic-based program designed to promote     the correct use of condoms among young African-American men newly diagnosed with a sexually     transmitted disease.   "
189096|NCT00314041|"     Infant phase: To determine the safety of and production of antibodies by a group C     meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine     vaccines.      Booster phase: To compare the safety of and production of antibodies by MnCC with and without     MMR and to compare the antibody response to that produced by a low dose of plain     polysaccharide vaccine as a way of investigating immune memory   "
189097|NCT00314054|"     The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with     chronic hepatic impairment and in matched healthy adults.   "
189098|NCT00314067|"     The purpose of this study is to disseminate and transfer the comprehensive quality management     interventions (CQM) for alcohol-related disorders in primary care developed during the first     funding phase into routine care. The two steps are (1) to optimize the CQM approach and (2)     to investigate the dissemination and transfer into routine care in a randomized controlled     trial.   "
189099|NCT00314080|"     Background. Northern Thailand's biggest botulism outbreak to date occurred on 14 March 2006     and affected 209 people. Of these, 42 developed respiratory failure, and 25 of those who     developed respiratory failure were referred to 9 high facility hospitals for treatment of     severe respiratory failure and autonomic nervous system involvement. Among these patients, we     aimed to assess the relationship between the rate of ventilator dependence and the occurrence     of treatment by day 4 versus day 6 after exposure to bamboo shoots (the source of the     botulism outbreak), as well as the relationship between ventilator dependence and negative     inspiratory pressure.      Methods. The investigators reviewed the circumstances and timing of symptoms following     exposure. Mobile teams treated patients with botulinum antitoxin on day 4 or day 6 after     exposure in Nan Hospital (Nan, Thailand). Eighteen patients (in 7 high facility hospitals)     with severe respiratory failure received a low- and high-rate repetitive nerve stimulation     test, and negative inspiratory pressure was measured.   "
189100|NCT00314093|"     Background:        -  CD4+ cells are white blood cells that regulate the immune system by controlling the          strength and quality of the immune response.        -  CD25+ cells are a subset of CD4+ cells that suppress or prevent immune responses.        -  RFT-5-dgA is an immunotoxin (substance that kills specific cells in the immune system)          that kills CD25+ cells.        -  In mouse studies, RFT-5-dgA showed anti-tumor activity in animals studies.      Objective: To determine whether the immune system of patients with metastatic melanoma     (melanoma that has spread beyond the original site) can cause tumors to shrink if the     patients are given RFT-5-dgA to remove their CD25+ cells.      Eligibility: Patients 18 years of age and older with metastatic melanoma whose disease has     progressed after receiving standard treatment.      Design:        -  Patients receive RFT-5-dgA through a vein every other day for a total of 3 doses (one          treatment course). Patients have routine blood tests during the week of treatment.        -  Four to 5 weeks after the last dose, patients are evaluated with a physical examination,          blood tests and scans and x-rays to evaluate their tumor.        -  Patients whose tumor has shrunk or remained stable may be offered additional treatment          with RFT-5-dgA up to a total of four courses.        -  Patients undergo leukapheresis or have several tubes of blood drawn from a vein to          determine the effects of RFT-5-dgA on the immune system. This is done before the first          dose of RFT-5-dgA, after the first three doses, and possibly during subsequent treatment          courses in those patients who receive additional treatment. For leukapheresis, blood is          collected through a needle in an arm vein and flows through a catheter into a machine          that separates it into its components by spinning. The white cells are extracted and the          rest of the blood is returned through another needle in the other arm.   "
189101|NCT00314106|"     Background:        -  In a study in humans with melanoma, patients given total body irradiation to suppress          the immune system in conjunction with chemotherapy showed a significant clinical          response.        -  In previous studies, about one-half of patients given tumor-fighting cells (cells          created from the patient's tumor cells and grown in the laboratory) showed some          anti-tumor response.      Objective: To determine whether tumor-fighting cells taken from a melanoma tumor and grown in     the lab can more effectively at fight melanoma when the patient's immune system is suppressed     and cannot attack them.      Eligibility: Patients 18 years of age or older with metastatic melanoma who have tumor     reactive cells available.      Design:      -Patients are assigned to one of two groups - those having received prior therapy with     Interleukin-2 (IL-2) and those who have not.      After five days of injections of filgrastim, a medicine to stimulated the growth of white     blood cells, patients undergo apheresis or bone marrow harvesting, or both, to collect stem     cells for later re-infusion. For apheresis, whole blood is collected through a needle in an     arm vein and circulated through a cell-separating machine where the stem cells are extracted.     The rest of the blood is returned through the same needle or a needle in the other arm. Bone     marrow harvesting is done under general anesthesia. Stem cells are collected through a large     needle inserted into the hipbone.-Patients' immune system cells and bone marrow function are     eliminated with chemotherapy (7 days) and total body irradiation (3 days) so the patient's     immune system cells will not fight the tumor-fighting cells they are given in treatment.        -  1 to 3 days after total body irradiation, patients receive the tumor-fighting cells by          intravenous (IV) infusion. After the cells are infused, they receive interleukin-2          (IL-2) infusions every 8 hours for 5 days.        -  2 days after infusion of the tumor-fighting cells, patients receive the stem cells          collected earlier by apheresis.        -  Patients are evaluated 4 to 6 weeks after cell infusion to look for tumor response to          treatment. Patients whose tumor has not grown return to the National Institutes of          Health (NIH) every 1 to 3 months for blood tests, scans and x-rays.   "
189112|NCT00314249|"     The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a     dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with     fibromyalgia.   "
189113|NCT00314262|"     Evaluate effect on cells and patient response to study medications, assess side effects of     these medications, and evaluate chemicals in cells that may tell how the drug works, before,     and after receiving the study medications.   "
189114|NCT00314275|"     The purpose of this study is to evaluate the pharmacokinetics (PK) and safety associated with     ABT-578 administered using the Medtronic Endeavor Drug Eluting Coronary Stent system in the     treatment of single de novo lesions in native coronary arteries between 2.5 - 3.5 mm in     diameter.   "
189102|NCT00314119|"     This study will explore the growth of dermal neurofibromas (skin tumors) in patients with     neurofibromatosis type 1 (NF1). Investigators will try to learn: 1) how fast (or slow) these     benign tumors grow in NF1, 2) how often new tumors appear and 3) what genes are involved in     the growth of the tumors.      Men and women between 20 and 50 years of age diagnosed with NF1 and their biological parents     are eligible for this study.      Patients with NF1 are evaluated at the NIH Clinical Center with the following tests and     procedures:        -  Medical examination and drawing of family tree.        -  Photos of the back, abdomen and thigh in order to count the number of skin tumors.        -  Photos of the skin taken with a special camera (Primos camera) that takes very detailed          pictures of a small area of skin.        -  Photos of the skin taken with a dermatoscope, which takes very detailed pictures of a          small area of skin under high magnification.        -  Biopsy of at least one skin tumor and biopsy of a small piece of normal skin.        -  Blood sample collection for genetic testing of the gene NF1 and to establish a cell          line.        -  Other medical tests (e.g., x-rays or MRI) if needed.      Patients and their families will also have a genetic counseling session and an opportunity to     ask questions about neurofibromatosis type 1.      Patients return to the NIH after 3, 6, 12, 18 and 24 months for follow-up photographs and     possibly blood samples.      Biological parents of patients provide a blood sample for genetic testing.   "
189103|NCT00314132|"     The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be     used for vaccination against Japanese encephalitis) is safe and well tolerated when compared     to placebo (dummy) vaccination.   "
189107|NCT00314184|"     This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to     evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up     to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
189108|NCT00314197|"     The investigators propose to conduct a randomized controlled trial at the patient level of     the Telephone Linked Care - Behavioral Change (TLC-BC) system, which is designed to promote     smoking cessation, reduce risky drinking, and improve physical activity and diet. They expect     to:        1. successfully integrate an automated telephone behavior change intervention into primary          care practices;        2. demonstrate improvement in health behaviors for individuals randomized (assigned by          systematic chance) to use the TLC-BC system compared to individuals who receive written          health education informational packets; and        3. evaluate the direct costs associated with the use and operation of the TLC-BC system.      Project aims and hypotheses follow:      Aim 1: Integrate a proven, totally automated computer telephone intervention, Telephone     Linked Care - Behavior Change (TLC-BC), into primary care practices. This will be assessed by     the patient and clinician/staff surveys at the end of data collection.      Aim 2: Demonstrate an improvement in health behaviors for individuals randomized to use the     TLC-BC system compared to individuals who receive written informational packets.      Aim 3: Evaluate the direct costs associated with the use and operation of the TLC-BC system     within the primary care setting.      Hypothesis 1: The Telephone Linked Care - Behavioral Change system will be successfully     implemented by patients and practices.      Hypothesis 2: At 6 months a clinically significant improvement in behavioral change rates     will be demonstrated for diet, physical activity, and smoking in the intervention group     compared to patients in the control group.      Hypothesis 3: At baseline, 3, 6, and 9 months risky drinking will be identified, but there     will be no difference in improvement between the study groups.   "
189109|NCT00314210|"     The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to     placebo in increasing time from randomisation to an anxiety event in patients with     generalised anxiety disorder (GAD).      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
189110|NCT00314223|"     Background: Sinus node dysfunction is a major cause of bradycardia necessitating pacemaker     implantation. Evidences of genetic study supported that some genes involved in the pacemaker     current or renin-angiotensin system were related to sinus node dysfunction. However, the     influence of gene polymorphisms on sinus node dysfunction was not well studied.      Methods: A group of 100 patients with documented sinus node dysfunction and 100 age- and sex-     matched healthy control patients will be enrolled into this study. Gene polymorphism study     includes the angiotensin-I converting enzyme gene, angiotensin II type 1 receptor gene,     HCN1-4, SCN5A, KCNE and other possible gene polymorphisms which are related to sinus node     function based on previous reports. Genetic polymorphisms are identified with polymerase     chain reaction-based restriction analysis. Comparison of multiple haplotype analysis and     single-locus analysis will be analyzed between the cases and controls.      Estimated Results: Some genetic polymorphisms of these genes which are related to sinus node     function or rennin-angiotensin system will show association with sinus node dysfunction. In     multilocus haplotype analysis, some genetic haplotype profiles may demonstrate significant     difference between cases and controls. In single locus analysis, some genetic polymorphisms     may be associated with sinus node dysfunction.      Estimated Conclusion and Clinical Implication: This study will demonstrate the genetic     polymorphisms in RAS genes or some other genes associated with sinus node dysfunction. These     results will support the roles of these genetic polymorphisms in determining the risk of     sinus node dysfunction among the Chinese population in Taiwan.   "
189111|NCT00314236|"     This study will investigate whether the treatment of damaged cartilage in the knee with     BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with     microfracture alone. Furthermore, the effect of BST-CarGel in decreasing cartilage related     pain and improving cartilage-related function in the knee will be assessed.   "
189117|NCT00314314|"     It is hypothesized that the intranasal administration of insulin will enhance     hippocampal-dependent neurocognitive performance in euthymic patients with bipolar I or II     disorder. This novel initiative represents a proof-of-concept study that insulin is salient     to neurocognitive functioning and deficits in bipolar disorder and represents a novel and     safe therapeutic avenue. The available literature suggests that the acute administration of     intranasal insulin enhances cognition in memory impaired older adults with either Alzheimer's     disease or minimal cognitive impairment. Prior research demonstrates a cognitive enhancing     effect of insulin within one hour of the first intranasal insulin dose. Other studies suggest     that the long-term administration of intranasal insulin (i.e. over eight weeks) in enhances     memory performance in human volunteers. We aim to evaluate the acute and long-term effects of     intranasal insulin administration in persons with bipolar disorder. As such we will be     conducting the neuropsychological testing at three time points, the week before receiving     insulin, within one hour of the first dose and after 8 weeks of insulin administration.   "
189118|NCT00314327|"     The purpose of this project is to evaluate the efficacy of long-acting risperidone for     patients with first episode schizophrenia spectrum who did not improve sufficiently with the     first antipsychotic medication they tried during their initial treatment trial.   "
189119|NCT00314340|"     Characterize the relative abuse liability of a short versus a long acting opioid in chronic     pain patients.   "
189120|NCT00314353|"     Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation     in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to     kill cancer cells directly. This study is being done to see how colorectal cancer responds to     treatment with the combination of bevacizumab and chemotherapy.   "
189150|NCT00314743|"     The purpose of this study is to determine the efficacy of aprepitant in preventing acute and     delayed chemotherapy induced nausea and vomiting when administered in combination with     intravenous or oral ondansetron and intravenous or oral dexamethasone in the autologous     transplant setting.   "
189151|NCT00314756|"     To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after     initial treatment with curettage   "
189121|NCT00314366|"     Recent studies have suggested that it may be possible to grow new blood vessels     (angiogenesis) to supply the heart muscle that is currently not getting enough blood. One     theory is that a certain type of stem cell, aldehyde dehydrogenase bright stem cells, may     stimulate the growth of new vessels. After a bone marrow procedure, the special cells are     separated and then injected back into the heart around the area of damage with a special     guidance and injection system.      Once a patient meets all inclusion criteria and no exclusion criteria, he/she will be     consented to the study and extensive baseline testing will be completed at St. Luke's     Episcopal Hospital in Houston, Texas. Once all baseline criteria are met, the patient has     his/her own bone marrow harvested and later injected, if randomized to receive active     treatment. The day after the bone marrow harvest, the patient is taken to the cardiac     catheterization lab where NOGA mapping is performed and the processed cells or placebo are     injected under electromechanical guidance into the affected areas of the left ventricle. The     patient is usually discharged home the next day and returns for follow-up at weeks 1 and 4,     and months 3 and 6, and at one year unless there is a crossover and then he/she begins     baseline again at 6 months and follow-up for one more year. Follow-up testing, including     quality of life and NOGA mapping, is done at the time of injection, as well as at 6 months.   "
189122|NCT00314379|"     The ICARE study, clinicaltrials.gov ID number: NCT00220831 and protocol number KL-2004, is     recruiting diabetic patients with haptoglobin phenotype 2-2, which are randomised to either     Vitamin E 400IU per day or placebo. Patients will be followed for 4 years for the major     cardiovascular complications of diabetes, acute myocardial infarction (MI), stroke and     cardiovascular mortality (see ICARE protocol). The EFI study, Endothelial Function in ICARE     will recruit a sample group of 50 patients from the ICARE cohort. These patients will     complete all requirements by ICARE protocol and in addition will be tested for endothelial     function by a non-invasive method of flow mediated dilatation (FMD).   "
189123|NCT00314392|"     The response to standard pain stimuli in males and females is investigated, together with the     effect of informing participants about the effect of a painkiller. Physiological response to     pain is recorded.   "
189124|NCT00314405|"     The aim of this study is to evaluate the performance of a double labelling method using     isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a     series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and     patients: SLN excision will be performed on 100 patients treated for infiltrative breast     cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual     localization of the radioactive and stained nodes will be performed. After the surgery, SLN     will be submitted to serial analysis and immunohistochemistry. A comparison of the two     methods and an economical evaluation of the complete procedure will be performed.   "
189125|NCT00314418|"     Colonoscopy is usually associated with coiling (looping) of the colonoscope (instrument     used for the procedure) in parts of the bowel. This is the main reason for patient discomfort     and lengthens the duration of the procedure. Minimizing the coiling of the colonoscope would     decrease the duration, and improve the efficiency and tolerability of the procedure and have     a positive impact on colon cancer screening.      The primary aim of this study is to compare the time it takes for the colonoscope to reach     the end of the colon when the patient is lying on the belly versus the left side (usual) at     the start of the procedure. Patients who have medical conditions that may be affected by     lying on their belly or those who cannot comfortably lie on the belly will be excluded from     the study. Changes in patient position and use of abdominal pressure (commonly given by the     endoscopy nurse during the procedure) will be permitted as necessary and determined by the     endoscopist. The endoscopist will also retain the decision to discontinue the patient's     participation from the study for any medical reason. After the procedure the patient will be     monitored in the usual manner and asked to fill out a satisfaction survey (24 hours after).   "
189126|NCT00314431|"     Based on success with telephone follow up for other groups of medically fragile infants, we     designed an innovative model of post-hospital comprehensive and coordinated follow-up for     infants with chronic lung disease. In this model, which we refer to as community-based     follow-up, medical management was coordinated by a nurse specialist, through frequent     telephone contacts with the infants’ primary caregiver. This model of follow up care was     compared, in a randomized trial, with the more traditional model - multidisciplinary medical     center-based care. We hypothesized that community-based care would lead to health and     developmental outcomes similar to those observed with center-based care.   "
189127|NCT00314444|"     This study will examine whether biofeedback treatment is effective in lessening or stopping     movement symptoms in people with psychogenic movement disorder. People with this condition     have increased or decreased movements that are not under their control and are not associated     with any know problem with the nervous system. Biofeedback is a type of therapy that uses     electronic instruments to monitor breathing and heart rate. This treatment has been effective     in patients with anxiety and panic attacks.      People 18 years of age and older diagnosed with psychogenic movement disorder may be eligible     for this study. Candidates are screened with a neurological history, physical examination and     psychiatric evaluation.      Participants come to the NIH Clinical Center for nine 1-hour test sessions over an 8-week     period for the following procedures:      Week 1 (two visits):        -  Patients' movements are videotaped while they sit, stand and walk.        -  Patients train on RESPeRATE device, a computerized musical biofeedback device to help          slow theirs breathing rate. The device has three components: a computerized module,          earphones, and a chest strap holding a breath sensor. The patients put the elastic strap          around their chest, put on the earphones, and sit in a chair. The device monitors and          analyzes their breathing to create a melody composed of two distinct tones - one for          inhalation and one for exhalation. Patients are instructed to match their breathing to          the tones, which gradually slow until they are breathing at a slower, therapeutic rate.        -  Patients' breathing is monitored and analyzed for information on breathing pattern and          rate.        -  Patients complete questionnaires on level of relaxation before and after RESPeRATE          training.        -  Patients take the RESPeRATE device home to use for two 10-minute practice sessions per          day. They complete relaxation questionnaires before and after each session.      Weeks 2-7:        -  Patients' progress is monitored and reviewed from the previous week        -  Patients' breathing is monitored and analyzed for information on breathing pattern and          rate.        -  Patients complete questionnaires on level of relaxation before and after RESPeRATE          training.        -  Patients are observed for 10 minutes while using the RESPeRATE device.      Week 8:        -  Patients' progress is monitored and reviewed from the previous week        -  Patients' breathing is monitored and analyzed for information on breathing pattern and          rate.        -  Patients complete questionnaires on level o...   "
189128|NCT00314457|"     The aim of this study is to determine whether the continuous intraarticular infusion of local     anesthetics in the postoperative period can improve analgesia and patients satisfaction after     knee and shoulder arthroscopy.   "
189129|NCT00314470|"     The purpose of this study is to retrospectively have access to image files of patients.   "
189174|NCT00315055|"     To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is     non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three     dose (2-3-4 month) primary series.      Immunogenicity        -  To assess pre- and post-primary series        -  To assess pre- and post-booster series.   "
189130|NCT00314483|"     Mesenchymal stem cells (MSC) have been shown to have immunosuppressive properties. Following     a bone marrow/peripheral blood stem cell transplant, a proportion of patients develop a     condition called ‘graft versus host disease’ (GVHD). In this condition the transplanted cells     recognize the recipient as foreign and bring about an immune-mediated destruction of tissues.     The treatment for this condition is to use drugs that will cause immunosuppression. A small     subset of these patients develop a severe form of GVHD (Grade III or IV) which, in spite of     the best currently available treatment, is associated with eventual death in more than 90% of     cases. The investigators propose to use infusions of expanded MSC from the donor to treat     this condition. A few reports on this approach have already been published in peer reviewed     journals and preliminary results appear to be promising. The investigators are also aware     that larger trials have been initiated to study this. After getting written informed consent,     the investigators will infuse expanded MSC into patients who develop steroid-resistant GVHD.   "
189131|NCT00314496|"     Retrospectively have access to MR images of patients to develop software that:        1. segment images        2. convert MR values to electron density and then        3. entered into a dose calculation system      The project involves software development of data that is already available. No intervention     is made at this point.   "
189132|NCT00314509|"     The aim of the study is to compare the efficacy of two doses of a fixed combination of     ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in     patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a     treatment period (8 weeks). The study will provide further data on safety and tolerability of     ciclesonide/formoterol fumarate.   "
189133|NCT00314522|"     This study performed a retrospective analysis of patient images to develop software in     determining dose delivered for each fraction treatment.   "
189134|NCT00314535|"     Magnetic resonance (MR) spectroscopic techniques are to be developed to obtain the best data     possible at 3 Tesla (3T) for the prostate.   "
189135|NCT00314548|"     Summary of the proposed research:      The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has been     used to cause a decrease not only of the pulmonary but also of the systemic vascular tone.     Aerosolized prostacyclin, on the other hand, can result in a selective pulmonary     vasodilatation without affecting the systemic blood pressure as shown in preliminary     studies/case reports. No large trials exist for this type of use of the drug so far.     Furthermore, aerosolized PGI2 can improve gas exchange and pulmonary shunt in clinical     settings of impaired ventilation/perfusion ratio as it occurs in adult respiratory distress     syndrome (ARDS) due to the redistribution of pulmonary blood flow from non-ventilated to     ventilated, aerosol accessible lung regions. Therefore, the investigators propose to carry     out a prospective, double blinded, randomized trial to show that the nebulized iloprost     decreases pulmonary hypertension selectively and improves oxygenation in ARDS.   "
189136|NCT00314561|"     Pioglitazone and rosiglitazone are used in the treatment of diabetic patients.     Thiazolidinediones increase insulin sensitivity and show favorable effect blood glucose     levels and lipid profiles. The effect of these two different thiazolidinediones on     atherosclerotic and inflammatory markers has not been compared in prospective manner. The     purpose of this prospective, randomized, open-label, crossover trial is to compare the effect     of pioglitazone and rosiglitazone on atherosclerotic and inflammatory markers in patients     with metabolic syndrome.   "
189137|NCT00314574|"     This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy,     safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the     treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are     inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting     beta-agonists (LABA) with or without additional controller therapy.   "
189138|NCT00314587|"     The investigators created a randomized clinical trial between 1 or 2 elastic stable     intramedullary nails to find out what kind of treatment is optimal for unstable both-bone     midshaft forearm fractures.   "
189139|NCT00314600|"     The investigators created a randomized clinical trial to find out what kind of treatment is     optimal for non-dislocated both-bone midshaft forearm fractures.   "
189140|NCT00314613|"     Assured treatment with Risperal CONSTA will provide first-episode patients, who have a     greater potential for therapeutic response, with their best opportunity for continued     improvement in cognitive function beyond three months of treatment.   "
189141|NCT00314626|"     To evaluate the proportion of patients with virological failure after 48 weeks of treatment     with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once     daily as an antiretroviral simplification regimen.   "
189142|NCT00314639|"     Patients suffering from schizophrenia and schizophrenia spectrum psychosis frequently     experience cognitive impairments. Such deficits may affect memory, attention and executive     function processes. Many studies have shown that cognitive impairments predict daily     functioning. Improvement of these difficulties represents a major component of recovery in     such population. Second generation antipsychotics, now first line intervention, have been     shown to improve cognitive processes compared to first generation agents. However, more     subtle cognitive impairments may still remain. In fact, cognitive impairments is one of the     most frequent subjective complaints from patients and their family, even though antipsychotic     treatment has been optimized. Very few options are available to clinicians to try to improve     such persistent cognitive difficulties. First, cognitive remediation techniques have shown     some effectiveness but results are sparse and come from a very small number of studies. It is     also not clear if cognitive improvement obtained from such techniques would apply to daily     functioning and can be generalized.A second possible intervention would be to add a     pharmacological agent able to improve cognition. Modafinil (Alertec) is officially indicated     for improving wakefulness in patients with excessive daytime sleepiness associated with     narcolepsy. Some empirical data and clinical observations suggest that modafinil could     improve alertness and/or cognitive functioning without exacerbating psychotic features in     persons with schizophrenia and psychotic disease in the spectrum of schizophrenia. This study     aims to (a) assess the effect on cognitive functioning of modafinil as an adjunctive to a     second generation antipsychotic in a prospective cohort of thirty patients suffering from     schizophrenia and psychosis in the spectrum of schizophrenia. This study will also (b)     evaluate the impacts of the addition of modafinil on side effects, psychopathology symptoms     and other health parameters (such as weight, metabolic profile, etc.). Our principal     hypothesis is that significant improvements will be observed on attention processes without     any exacerbation of psychotic symptoms or major emerging side effects. This cross-over     placebo-controlled prospective study will include patients with schizophrenia or psychosis in     the schizophrenia spectrum according to DSM IV definition, men or women aged over 18 years     old, with no item score equal or over 5 at PANSS positive symptoms subscale. At enrollment,     all patients will have to experience significant cognitive difficulties with scores equal or     lower than Z=-1.00 at Color trail test, Mesulam and Weintraub Cancellation Test, Stroop test     or Continuous Performance Test-II. Patients will be exposed to 100mg daily of Placebo or     Modafinil for 2 weeks than to 200mg daily for the two following weeks. A two weeks wash out     period will then take place before the same sequence will be start again. Patient will thus     be exposed one month to placebo and one month to modafinil or conversely, in a random     fashion.Assessments will include neurocognitive standardized battery, psychopathological     tools (PANSS, CGI, SOFAS, SDS), side effects (UKU, ESRS, DAI), vital signs, anthropometric     and metabolic profile.   "
189143|NCT00314652|"     The objective of this study is to assess the safety and efficacy of the buprenorphine     transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects     with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.   "
189144|NCT00314665|"     This research study is for patients that have been diagnosed with chronic uveitis, a disease     that causes inflammation in the eye. Patients are currently being treated with Remicade,     Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation.     Despite these medications, patients still have inflammation in their eyes. Patients are being     asked to add an additional drug, thalidomide.   "
189145|NCT00314678|"     Clinically, there has been extensive experience with topotecan and cisplatin. Recently,     several investigators have evaluated the combination of paclitaxel, cisplatin and topotecan.     As expected, myelosuppression was the dose-limiting factor. Herben et al recently reported     the results of a phase I trial using the combination of paclitaxel, cisplatin, and topotecan     as first line therapy in advanced stage ovarian cancer. Interestingly, the authors could not     achieve a dose of topotecan that would be considered optimal for the treatment of relapsed     disease in a single-agent fashion. The inability to utilize a therapeutic dose when combined     with either platinum or paclitaxel has been demonstrated in previous reports and affirms the     bone marrow suppressive effect. The clinical response rate from this trial was reported as     86.7%.   "
189427|NCT00318591|"     The purpose of this study is to investigate the frequency of urinary tract infections with     symptoms in spinal cord injured patients requiring intermittent catheterization for emptying     the bladder. Patients will use either a coated catheter or an uncoated catheter with gel.   "
189152|NCT00314769|"     This study will examine whether continuous use of transcranial direct current stimulation     (tDCS) in combination with motor training can lead to long-term improvement in movement     performance beyond what can be achieved with motor training alone.      Healthy normal volunteers 18-80 years of age who are clearly right- or left-handed may be     eligible for this study. Each candidate is screened with a medical history, clinical and     neurological examination, questionnaires to evaluate memory, attention, and handedness and a     brain MRI, if one has not been done by NINDS within 12 months of entering the study. Pregnant     women may not participate.      The study involves 10 sessions (in addition to the screening visit) over 3 months. Sessions     1-5 are completed over 5 consecutive days. Sessions 6-10 are divided over the remaining time.     Participants are randomly assigned to one of three groups: 1) tDCS during motor training; 2)     tDCS after training; or 3) training with sham tDCS. During these sessions, participants     perform a pinch force task (squeezing a small device between the thumb and forefinger) and     visuomotor tasks (using a device to move the cursor on a computer screen to various targets     and holding the cursor in place for 1 second).      During the motor training and performance sessions, participants have the following     procedures.        -  TMS measurements: A wire coil is held on the scalp, and a brief electrical current is          passed through the coil, creating a magnetic pulse that stimulates the brain. During the          stimulation, the subject may be asked to tense certain muscles slightly or perform other          simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg,          and the subject may hear a click and feel a pulling sensation on the skin under the          coil.        -  tDCS: Small, wet sponge electrodes are applied to the head - one above the eye and the          other on the back of the head. A small electrical current is passed between them. The          subject may feel an itching or tingling sensation under the electrodes or see light          flashes. Some sessions are done with sham tDCS.        -  Surface electromyography: Electrodes are filled with a conductive gel and taped to the          skin over one small hand muscle to measure the electrical activity of muscles.        -  Behavioral measurements: Evaluation of learned movement tasks        -  Questionnaires to evaluate the subject's attention, fatigue and mood before and after          testing   "
189153|NCT00314782|"     Two-part, multi-center study design to establish a maximum tolerated dose (MTD) of ZD4054 in     combination with docetaxel and to explore its safety, tolerability, pharmacokinetic (PK)     profiles and clinical efficacy in patients with metastatic hormone-refractory prostate cancer     (HRPC)   "
189154|NCT00314795|"     The purpose of this study is to evaluate the ability of peginesatide to increase and maintain     increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on     dialysis, receiving regular hemodialysis or peritoneal dialysis, or following renal     transplant) with confirmed antibody-mediated pure red cell aplasia (PRCA).   "
189155|NCT00314808|"     This study seeks to define the tolerability and safety associated with the administration of     Dronabinol in the treatment of adults with nausea, vomiting and appetite loss in patients     with primary gliomas who are undergoing chemotherapy treatment. The study will also describe     the effect of Dronabinol on the quality of life in terms of nausea, vomiting and anorexia in     this patient group.   "
189156|NCT00314821|"     To demonstrate efficacy and safety of Requip in in treating bipolar depression.   "
189157|NCT00314834|"     IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to     evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional     status, dialysis efficacy, Karnofsky score   "
189171|NCT00315016|"     The purpose of this study is to determine whether eplerenone is more effective than doubling     the dose of ACE inhibitor in reducing urinary protein (albumin) loss in diabetes mellitus   "
189199|NCT00315380|"     Eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA) is a rare immune system     disorder that causes asthma, an excessive number of eosinophils (a type of white blood cell)     in the blood, and the inflammation of blood vessels, or vasculitis. In order to properly     treat EGPA, it is critical that the level of disease activity can be determined over the     course of the disease. The purpose of this study is to determine new biological markers, or     biomarkers, that may be used to assess the severity of this disease in people with EGPA.   "
189273|NCT00316563|"     To investigate delta-9-tetrahydrocannabinol's (THC) ability to increase food intake and     improve food enjoyment for advanced cancer patients with taste and/or smell (chemosensory)     abnormalities.   "
189158|NCT00314847|"     Cardiogenic shock is currently the main cause of death after myocardial infarction and 50% of     deaths occur within the first 48 hours. To limit the extent of the myocardial necrosis is the     primary objective of the treatment in this context. The symptomatic treatment of the     ventricular failure alone does not allow a reduction of mortality. The immediate prognosis is     not significantly improved by the current standard of care, including early revascularisation     and intra-aortic balloon counterpulsation.      In order to improve the immediate prognosis, it seems necessary to limit the irreversible     myocardial lesions and the systemic inflammatory response induced by an extended myocardial     infarction (complement activation, cytokines production, iNOS expression, etc.). These     objectives may be reached by a more extended utilization and availability of circulatory     assistance methods.      The investigators propose to compare, in a randomised multicenter study, two treatments of     the myocardial infarction with cardiogenic shock among 44 patients:      Standard Treatment versus ECLS-Impella +/- standard treatment.      In June 2007, an amendment replaced the device ECMO by the use of Impella intra-thoracic     pump.      This amendment has been approved by the Ethic Committee on July 7, 2007. In March 2009, a new     amendment has been approved by the EC. This amendment allowed to revise the number of     patients to enroll (reduced to 44) and this lead us to modify also the primary endpoint :     variation of BNP levels between H0 and H24 (H0 defined as the nearest value of BNP level     obtained before the randomization).Showing a more important BNP levels decrease in the     experimental group compared to standard treatment group, the investigators obtain an indirect     argument to show a superior efficacy of the tested strategy.   "
189159|NCT00314860|"     Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with     extended release ropinirole over 12 weeks   "
189160|NCT00314873|"     This study is important to demonstrate if single agent activity is noted for patients with     thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens     the door to evaluate other combination of drugs with imatinib in thymic tumors.   "
189161|NCT00314886|"     Despite there being no clearcut advantages, one of the most common recommendations in IBS     management is to increase the amount of dietary fibres. In some IBS patients fibres have a     deleterious effect on pain and bloating. It has been shown that butyrate can increase colonic     sensitivity in rats. Our purpose is to study whether butyrogenic fibres can modify rectal     sensitivity and symptoms in IBS and healthy control through a modification of colonic flora.   "
189205|NCT00315458|"     The original objective of this study was to assess the safety and efficacy of the     buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal     system in subjects with moderate to severe osteoarthritis pain. However, this study was     terminated early with only 35% of the planned sample size, therefore the primary objective is     changed to focus on the safety evaluations.   "
189162|NCT00314899|"     The purpose of this study is to find out what effect malaria in the mother has on the     development of her child's immune system response to malaria and whether being exposed to     malaria in the womb makes a child more likely to get malaria. The study will also assess the     effect that exposure to malaria in the womb has on the child's growth and development over     the first three years of life. Study participants will include 480 healthy pregnant women     (greater than or equal to 15 years of age), their healthy offspring, 20 healthy people from     the United States with no malaria exposure or disease and 40 adult Kenyans who have     previously been exposed to malaria or have malaria with no signs of infection. Study     procedures will include an ultrasound (procedure to assess the baby's growth and development     in the womb), blood, urine, and stool collections. Newborns will be examined at birth, and at     6, 12, 18, 24, 30 and 36 months of age.   "
189163|NCT00314912|"     The purpose of this Phase III open-label extension study is to evaluate the long-term safety     of Tramiprosate (3APS) in patients with mild to moderate Alzheimer’s disease.   "
189164|NCT00314925|"     The primary purpose of the study is to determine if Seneca Valley Virus may be administered     safely to patients with certain types of advanced cancer.   "
189165|NCT00314938|"     This will be the first clinical study of the development of PHA-794428 in a pediatric     population. Since differences in PK and/or PD response may occur between adult and pediatric     subjects, it is deemed appropriate to first conduct an exploratory single dose study in     pediatric patients to assess safety and tolerability in this patient population. In addition     this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to     be tested in repeated dose phase 2b trials in children, using PK/PD modeling   "
189166|NCT00314951|"     This is a comparative study to investigate the safety and efficacy of fidaxomicin versus     vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).   "
189167|NCT00314964|"     The primary purpose of this study is to determine if PD-0299685 is effective and safe in the     treatment of vasomotor symptoms (hot flashes / flushes) associated with menopause.   "
189168|NCT00314977|"     2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer     using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or     sequential- is however unclear. The aim of the study is to compare the efficacy and     tolerability of neoadjuvant chemotherapy with AC followed by T(adriamycin, cyclophosphamide,     taxotere) versus TAC ( with upfront T) in patient with large resectable or locally advanced     breast cancer.   "
189169|NCT00314990|"     The VITRO (Vitamins and Thrombosis) study investigated the effect of homocysteine lowering by     daily supplementation of B-vitamins on the risk reduction of deep-vein thrombosis and     pulmonary embolism. Patients between 20 to 80 years old with a first objectively confirmed     proximal deep-vein thrombosis or pulmonary embolism in the absence of major risk factors and     a homocysteine concentration above the 75th percentile of a reference group were asked to     participate (hyperhomocysteinemic group). A similar study was conducted in a random sample of     patients with a homocysteine below the 75th percentile of the reference group     (normohomocysteinemic group). After informed consent patients were randomized to daily     multivitamin supplementation (5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin) or     placebo and were followed for 2.5 years. End-points were objectively diagnosed recurrent     deep-vein thrombosis or pulmonary embolism.   "
189170|NCT00315003|"     This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2-     treatmentgroup study in children (age range: ≥6 months and <72 months [< 6 years of age])     with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral     suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg     once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and     250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin     will also be dispensed to provide blinding for the different treatment regimens.Assessments     and reporting of safety will be carried out at all visits.   "
189172|NCT00315029|"     Background: The number of multiple pregnancies is considered to be the most important adverse     effect of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). IVF or     ICSI with transferring only one embryo, elective single embryo transfer (eSET), will reduce     this incidence remarkably. Unfortunately, former research has documented that cycles with SET     maintain lower pregnancy rates compared to double embryo transfer (DET). Implementation of     eSET will require a carefully chosen and thoroughly defined implementation strategy focussed     on the couple undergoing the subfertility treatment. This trial will investigate the     (cost)effectiveness of a combined patient centred implementation strategy.      Objective: The main aim is to compare the effectiveness and costs of implementation of     elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic     sperm injection (ICSI), between usual care and a combined patient-centred strategy.      Study design: A randomised controlled trial      Study population: Couples with a female age less than 40 years ongoing an IVF/ICSI treatment     in 2 of the 13 Dutch IVF centres and their 4 satellite/transport centres.      Intervention A combined patient centred implementation strategy for eSET in IVF/ICSI. The     strategy consists of counselling through an evidence based decision aid and reimbursement of     a 4th cycle if couples have chosen for eSET in the first 2 cycles.      Primary study parameters/outcome of the study: the eSET occurrence rate, pregnancy outcomes     and cost-effectiveness of the combined strategy.      Secondary study parameters/outcome of the study:        -  patient knowledge        -  patient decisional conflict        -  patient satisfaction        -  IVF/ICSI treatment outcome.   "
189173|NCT00315042|"     This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled,     2 parallel treatment group study in subjects from 6 months to < 13 years of age, with     Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either     telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily     for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5     and 10 days respectively, to provide blinding to the different treatment regimens. A positive     rapid identification test for streptococcal Group A antigen will be required for all subjects     at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture,     identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.   "
189428|NCT00318604|"     This study investigates whether the amount of circulating plasma DNA can be used as a     response marker for anti-cancer treatment in treating gross tumors.   "
189175|NCT00315068|"     Catheter ablation using radiofrequency is a new therapeutic tool to treat atrial fibrillation     with a higher success rate than medical therapy (80% versus less than 50% respectively).     Because of the length of the intervention and of the risk of complications of the procedure,     it would be important to determine success rate before the intervention. The information     gained from this study will in all probability improve our estimation of the chances of a     successful intervention and may enable us to take necessary therapeutic measures in case of     an elevated risk of recurrence.      Multiple studies suggest that the 2 markers in this study could provide information of this     nature, however, their utility in the radiofrequency catheter ablation treatment of atrial     fibrillation has never been demonstrated.   "
189176|NCT00315081|"     Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the     dopamine receptors in the pituitary.Schizophrenic patients suffering from a     neuroleptic-induced hyperprolactinemia will be examined endocrinologically. Adverse drug     effects and diagnoses will be confirmed by measuring hormones.   "
189177|NCT00315094|"     The purpose of this study is to help people with home parenteral nutrition (HPN) to avoid     infections and feelings of depression or fatigue and to test how their health and quality of     life change over time. Another purpose is to test the nurse teaching sessions and the method     of obtaining support from the peer partner through videophone.   "
189178|NCT00315107|"     Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients     with resistance to somatostatin analogs.   "
189179|NCT00315120|"     The purpose of this study is to determine whether osteopathic manipulative treatment (a type     of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical     therapy are effective in the treatment of chronic low back pain.   "
189180|NCT00315133|"     The study evaluates the effect of inactivation of the immune system with chemotherapy and     immunotherapy and infusion of bone marrow stem cells in early onset type 1 diabetes mellitus.     We hypothesize that reprograming the immune system will stop immune aggression to the insulin     producing cells allowing their regeneration and thus decreasing or eliminating the need of     exogenous insulin.   "
189181|NCT00315146|"     The purpose of this pilot study is to compare two strategies intended to improve the health     of overweight older adults by improving body composition. One strategy, resistance training,     is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ     agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These     strategies will be used in conjunction with a hypocaloric diet and will be compared to a     hypocaloric diet alone to determine if either of these strategies are superior in reducing     visceral fat and preserving muscle mass.   "
189182|NCT00315159|"     The purpose of this study is to evaluate a less invasive procedure for the evaluation of the     inguinal (groin) nodes in patients with a primary squamous cell carcinoma of the vulva. Each     patient will undergo a sentinel lymph node dissection as well as resection of the primary     tumor on the vulva. Patients who are determined to have sentinel nodes that are negative for     metastatic disease will not receive a full groin dissection. Patients who have sentinel lymph     nodes that contain metastasis will undergo a complete inguinal dissection. The study will     evaluate the long-term outcomes in patients who receive only a sentinel lymph node dissection     without a complete dissection. All patients entered onto the study will have a biopsy proven     squamous cell carcinoma of the vulva. Each patient will be enrolled by a Gynecologic     Oncologist practicing out of Women & Infants Hospital   "
189197|NCT00315354|"     The aim of this study is to evaluate the effects of three dominant dietary patterns -     conventional low-fat, low-glycemic index (GI) and very-low-carbohydrate - on energy     metabolism and heart disease risk factors following weight loss in obese young adults in a     feeding study   "
189183|NCT00315172|"     Non-exercise activity thermogenesis (NEAT) is the energy expended engaging in daily     activities such as maintenance of posture, fidgeting, and other activities not specifically     designated as exercise. A growing body of evidence indicates that NEAT plays an important     role in overall energy balance; for example, differences in NEAT account for the ease with     which adults gain or lose weight during over- or under feeding. An intriguing and possibly     modifiable component of NEAT is fidgeting-like activity. In lean and overweight adults,     modulation of NEAT by augmenting fidgeting can increase short-term energy expenditure. It is     unknown whether NEAT can be altered in children, or whether augmenting NEAT in children can     change daily energy expenditure or body composition long-term. Children exhibit higher levels     of daily activity than adults, suggesting potentially profound differences in energy balance.     We propose to study the role of NEAT in children to determine if: a) the fidgeting component     of NEAT can be measured accurately and reproducibly in children; b) NEAT can be increased by     devices that remind children to engage in fidgeting-like activities; and c) manipulation of     fidgeting-NEAT can significantly change energy expenditure and body composition. Thirty lean     and thirty overweight children will be enrolled and treated in a pilot feasibility study. By     adapting technologies developed to measure activity in adults, children's behavior and     thermogenesis will be recorded and analyzed to study question (a). To address study questions     (b) and (c), we will ask children to wear a timer that vibrate on a fixed interval schedule     and be randomly assigned to two conditions: the intervention or active condition, during     which children will be cued by the timer to engage in a fidgeting behavior (rapidly moving     their heel up and down), and the control condition, during which children will be asked to     perform a less thermogenic activity (noting the cue). Children will then cross over so that     each child will complete both conditions. Primary outcome measures for question (a) will be     changes in energy expenditure when subjects are asked to fidget in a laboratory environment.     The correlation of these energy expenditure measurements with new activity monitoring     technologies will also be obtained, so that such equipment can be used for measurements under     free-living conditions. For study questions (b) and (c), compliance with prescribed fidgeting     regimens in a free living environment and the changes in energy expenditure and body     composition will be determined over a 2 week interval. This pilot study will enable the     determination of the sample size needed to assess the efficacy of a longer term NEAT     intervention in children.   "
189184|NCT00315185|"     The purpose of this study is to determine the role of cetuximab (Erbitux) with chemotherapy     for advanced colorectal carcinoma. This study will determine if this new agent can improve     one's response to standard treatment.   "
189185|NCT00315198|"     Ths purpose of this study is to determine whether near activities enhance the effect of     patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared     with distance activities in the treatment of moderate amblyopia and severe amblyopia in     children 3 to <7 years old.   "
189186|NCT00315211|"     The purposes of this study are:        -  To determine the overall response rate of patients treated with at least 2 cycles of          this regimen.        -  To determine the feasibility and toxicity of the combination of topotecan and docetaxel.   "
189204|NCT00315445|"     The objective of this study is to assess the safety of the buprenorphine transdermal system     (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/     acetaminophen in subjects with chronic back pain. The double-blind treatment intervention     duration is 84 days during which time supplemental analgesic medication (non-steroidal     anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.   "
189187|NCT00315224|"     The present work examines the impact of pulse pressure as a footprint of vascular ageing on     cardiovascular benefits of endurance training in elderly hypertensives. METHODS AND RESULTS:     54 patients ≥ 60 years with antihypertensive treatment and diastolic 24h-ambulatory blood     pressure (ABP) ≤ 90 mmHg are randomly assigned to sedentary activity or a heart-rate     controlled 12 week exercise program, consisting of walking on a treadmill at target lactate     concentrations of 2.5 ± 0.5 mmol/l. 24h-ambulatory blood pressure, physical performance,     arterial elasticity, endothelium-derived vasodilation, quality of life, and weight are     assessed at baseline and follow-up.   "
189188|NCT00315237|"     The purpose of this clinical research study is to learn if patients who receive vinflunine     plus best supportive care live longer than patients who receive best supportive care alone.     This study will also investigate patient benefit, safety and whether or not vinflunine     shrinks or slows the growth of the cancer.   "
189189|NCT00315250|"     We propose to build on preliminary data evaluating non-dopaminergic/non-motor clinical     biomarkers to more fully assess these markers at the threshold of Parkinson disease (PD).      Development of reliable biomarkers for both dopaminergic and non-dopaminergic manifestations     of Parkinson disease (PD) and related disorders may dramatically accelerate research on PD     etiology, pathophysiology, and therapeutics. Biomarkers are broadly defined as     characteristics that are objectively measured and evaluated as indicators of normal     biological processes, pathogenic processes, or pharmacologic responses to a therapeutic     intervention. Specific biomarkers may be useful at the onset of neurodegeneration, the onset     of disease, and/or to mark disease progression.   "
189190|NCT00315263|"     This research seeks to establish a neonatal DNA Tissue Bank to find out if differences in     small segments of DNA predispose babies to Chronic Lung Disease (CLD), Periventricular Brain     Injury (PVI), Necrotizing Enterocolitis (NEC), or Hypoxic Respiratory Failure (HRF).   "
189191|NCT00315276|"     The purpose of the study is to evaluate the efficacy and safety of modafinil administered     once daily for 9 weeks at doses of 255, 340, 425, and 510 mg as treatment for adults with     ADHD.   "
189192|NCT00315289|"     The purpose of this study is:        -  To report the success proportions of simple probing within different age groups of          patients under 24 months of age.        -  To obtain descriptive data regarding symptoms and quality of life in patients receiving          simple probing.        -  To obtain similar data for simple probing in patients 24 months of age or older, for          intubation in patients age 6 - <48 months, and for balloon catheter dilation in patients          age 6 - <48 months.   "
189193|NCT00315302|"     The purpose of the study is:        -  To compare the effectiveness and safety of weekend atropine augmented with a plano lens          for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100)          in children 3 to less than 7 years old.        -  To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine          treatment with and without a plano lens.   "
189194|NCT00315315|"     The purpose of this study is:        -  To report the success proportions for the treatment of persistent nasolacrimal duct          obstruction for three surgical procedures: balloon catheter dilation, nasolacrimal          intubation, and simple probing.        -  To obtain descriptive data regarding symptoms and quality of life in patients receiving          each type of surgical procedure, and to compare success proportions between patients          undergoing balloon catheter dilation and those undergoing nasolacrimal intubation.   "
189195|NCT00315328|"     The purpose of this study is:        -  To compare the effectiveness of weekend atropine plus near activities and daily patching          plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia          (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.        -  To determine the maximum improvement in vision of the amblyopic eye with each treatment.        -  To determine whether amblyopia is associated with structural abnormalities of optic          nerve fiber layer.   "
189196|NCT00315341|"     The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone     (BUP/NX) and methadone (MET) on indices of hepatic safety.   "
189198|NCT00315367|"     The purpose of this study is to determine if medication designed to improve memory will help     patients with Multiple Sclerosis (MS) who are experiencing memory problems using fMRI to     track brain activity.   "
189200|NCT00315393|"     Granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA) are two     rare immune system disorders that cause the inflammation of blood vessels, or vasculitis. In     order to properly treat these diseases, it is critical that the level of disease activity can     be determined over the course of the disease. The purpose of this study is to determine new     biological markers, or biomarkers, that may be used to assess the severity of disease in     people with GPA or MPA.   "
189201|NCT00315406|"     Polyarteritis nodosa (PAN) is a rare immune system disorder that causes swelling and damage     to small- and medium-sized blood vessels in the body. In order to properly treat this     disease, it is critical that the level of disease activity can be determined over the course     of the disease. The purpose of this study is to determine new biological markers, or     biomarkers, that may be used to assess the severity of disease in people with PAN.   "
189202|NCT00315419|"     Bone marrow failure syndromes (BMFS) are rare disorders characterized by dysfunctional     hematopoietic stem cells, which give rise to all red and white blood cells. The deficiency of     blood cells, or cytopenia, caused by this malfunction leads to an assortment of diseases and     disorders, all of which are characterized as BMFS. Because these diseases are rare,     conducting research on them is difficult, and standards of treatment for most BMFS have yet     to be developed. This study will collect clinical and laboratory data from people with BMFS     to identify the characteristics and biological markers associated with these diseases over     time. This information will assist doctors and researchers to develop better therapies and     diagnostic tests that will help improve the management of BMFS and cytopenias.   "
189203|NCT00315432|"     The purpose of this study was to describe the time course and extent of hemoglobin (Hb)     changes and the erythropoietic response to PEG-IFN/RBV (Pegylated Interferon and     Ribavirin)-induced anemia In HCV(hepatitis C virus)/HIV (human immunodeficiency virus)     co-Infected subjects.   "
189464|NCT00312520|"     The purpose of the study is to determine if pulse steroids are more efficacious and safer     than the standard treatment with oral corticosteroids.   "
189206|NCT00315471|"     Takayasu's arteritis is a rare disorder that causes swelling and damage to the large arteries     in the body, such as the aorta. In order to ensure proper treatment, measuring disease     activity is critical. The purpose of this study is to establish new biological markers     (biomarkers) to assess the severity of disease in people with Takayasu's arteritis.   "
189207|NCT00315484|"     The purpose of this study is to compare hemoglobin (Hgb) response rates between epoetin alfa     (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other     week) in anemic cancer patients receiving chemotherapy.   "
189208|NCT00315497|"     Giant cell arteritis (GCA), also known as temporal arteritis, is a disease that usually only     occurs in older adults. GCA causes inflammation of blood vessels, or vasculitis. In order to     properly treat this disease, it is critical that the level of disease activity can be     determined over the course of the disease. The purpose of this study is to determine new     biological markers, or biomarkers, that may be used to assess the severity of disease in     people with GCA.   "
189209|NCT00315510|"     Statins, including rosuvastatin, are drugs that lower plasma cholesterol and prevent     atherosclerotic disease. Recent preclinical evidence suggests that statins also increase     tissue tolerance to ischemia-reperfusion injury.      This is a randomized, double blind, parallel designed study comparing the effect of 1 week     treatment with rosuvastatin (20 mg, once a day) with placebo on forearm ischemia-reperfusion     injury in healthy male volunteers. Forearm ischemia-reperfusion injury is quantified with     Tc-99m-annexin A5 scintigraphy of the hands after a standardized ischemic exercise test. For     this purpose, Tc-99m-rh-annexin A5 (400 MBq; < 5 mSv) is injected intravenously upon     reperfusion, followed by scintigraphy of both hands with a gamma camera at 1 and 4 hours     after injection. Annexin A5 targeting is calculated as the percentage difference in activity     (counts/pixel) between the thenar muscles of both hands.   "
189210|NCT00315523|"     To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered     once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring     in subjects exposed to ragweed pollen in an environmental exposure unit.   "
189211|NCT00315536|"     Study to investigate the influence of remifentanil and glycopyrrolate on cardiac index and     blood pressure in children.To differentiate between contractility and the effect of the     circulating volume, some of the subjects will receive additional fluid.This will be evaluated     using two transthoracic echocardiac exams within the first 30 min of anesthesia.   "
189212|NCT00315549|"     This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel     treatment group study in subjects equal to or over 13 years of age, with Streptococcus     pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400     mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg     over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules     will be dispensed to maintain the blind between the treatment groups.A positive rapid     identification test for streptococcal Group A antigen will be required for all subjects at     Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture,     identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.   "
189213|NCT00315562|"     Pilot study of early versus delayed carotid endarterectomy (CEA) for small to medium-sized     ischemic stroke caused by high-grade carotid stenosis.   "
189214|NCT00315575|"     The purpose of this study is to develop imaging techniques that can distinguish functional     brain changes in people at high risk for dementia years prior to onset of clinical memory     problems from those with normal changes of aging.   "
189217|NCT00315614|"     SPECIFIC AIMS:        -  To reverse hyperglycemia and insulin dependency in patients with Type 1 diabetes          mellitus by islet cell transplantation.        -  To induce a state of donor specific tolerance and eliminate the need for continuous          immunosuppressive therapy by simultaneous transplantation of donor bone marrow cells          with islets and utilization of the monoclonal antibody Campath-1H for induction of          Immunosuppression.        -  To assess long-term function of successful islet cell transplants in patients with Type          1 diabetes mellitus.        -  To determine whether the natural history of the microvascular, macrovascular and          neuropathic complications are altered following successful transplantation of islet   "
189218|NCT00315627|"     The purposes of this study are:        1. To reverse hyperglycemia and insulin dependency in patients with type 1 diabetes          mellitus through islet transplantation utilizing steroid free, calcineurin-inhibitor          free immunosuppression.        2. To assess the long-term function of successful islet transplants in patients with type 1          diabetes mellitus utilizing islets that have undergone a period of culture.        3. To determine whether the natural history of the microvascular, macrovascular, and          neuropathic complications are altered following the successful transplantation of          islets.   "
189219|NCT00315640|"     The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot     when administered for the treatment of elevated IOP following treatment with steroids.   "
189220|NCT00315653|"     The purpose of this clinical trial is to evaluate the ability of urinary Survivin mRNA     measurement to estimate the risk of bladder cancer at the time of cystoscopy in subjects with     no prior history of bladder cancer presenting with microscopic or macroscopic hematuria.   "
189221|NCT00315666|"     The purpose of this study is to test whether memantine has a prophylactic effect on chronic     tension-type headaches.   "
189222|NCT00315679|"     This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline     (oxpentifylline) for the treatment of recurrent mouth ulcers.   "
189223|NCT00315692|"     The purpose of this clinical trial is to evaluate the ability of multiple serum biomarkers to     estimate the risk of ovarian cancer in women presenting with pelvic mass (defined as a     simple, complex or a solid ovarian cyst / pelvic mass).   "
189233|NCT00315822|"     The investigators propose to test the hypothesis that the incidence of major complications     related to infection or inadequate healing is reduced in morbidly obese patients given 80%     inspired oxygen during, and for 12-18 hours after, surgery compared with patients given 80%     oxygen only during surgery. The primary outcome will be a composite of major complications     plausibly related to infection or healing.   "
189224|NCT00315705|"     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the     treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute     lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is     based on the induction of complete responses. Randomized trials demonstrating increased     survival or other clinical benefit have not been conducted.      The purpose of the phase 1 portion of this study was to determine if clofarabine added to a     combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory     acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the     phase 2 portion of the study was to measure the effectiveness of the combination therapy in     children with ALL.   "
189225|NCT00315718|"     In patients with diabetes mellitus type 2 stably adjusted to diet long-term intake of     aqueous-ethanolic extract from Hintonia latiflora over more than 12 months leads to a     statstically significant amelioration of parameters of glycaemic control (HbA1c, postprandial     and fasting glucose) not acchievable with diet alone.      As safety parameters, liver function tests and cardiovascular parameters are to be monitored.     Adverse events are to be monitored.   "
189226|NCT00315731|"     Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131     Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from     testing done on blood samples drawn at 12 timepoints over the first 7 days following     administration of the dosimetric dose. Whole body gamma camera images will be obtained on six     days following the dosimetric dose. Organ and tumor dosimetry data will be generated from     gamma camera counts of specific organs and tumor. All scans will be examined by an     independent review panel to evaluate biodistribution of the radionuclide.      Using the dosimetric data from three of the six imaging time points and the patient's weight,     a patient-specific activity (mCi) of Iodine-131 will be calculated to deliver the desired     total body dose of radiation (75 cGy). Patients will receive an infusion of unlabeled     Tositumomab (450 mg) immediately followed by an infusion of the patient specific dose of     tellurium-derived Iodine I 131 Tositumomab (35 mg) to deliver a total body dose (TBD) of 75     cGy. Patients will be followed closely obtaining safety information during the post-treatment     period, and for response and safety at 3,6,and 12 months during the first year, annually     thereafter up to five years, and annually for additional safety and outcomes information up     to 10 years.   "
189227|NCT00315744|"     Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an     adjustment of their asthma therapy. Current guidelines suggest that the treatment options are     either an increased dose of inhaled corticosteroid or the addition of other therapy such as a     long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to     high dose ICS therapy are growth retardation and the suppression of the     hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that     a combination product that included a LABA as well as the ICS allowed to reduce the steroid     dose and was still at least as effective in achieving asthma control as treatment with a     higher dose of ICS. These treatment options shall be compared in the present study. Children     who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized     to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or     fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of     eight weeks.   "
189228|NCT00315757|"     The purpose of this study is to evaluate the efficacy (disease response) and safety of     mapatumumab in combination with bortezomib and bortezomib alone in subjects with relapsed or     refractory multiple myeloma (MM).   "
189229|NCT00315770|"     This is a controlled, randomized, intervention trial (CRIT) with 20-40 year old overweight     individuals (n = 320) across Europe in order to distinguish between biologically active     components of seafood, i.e., seafood proteins and n-3 lipids, regarding their effects on risk     factors for metabolic syndrome, bone health, and weight management.   "
189230|NCT00315783|"     Compare data (structural and functional) obtained by transthoracic rest echocardiography and     magnetic resonance imaging (with gadolinium) in 30 patients with hypertrophic cardiomyopathy   "
189231|NCT00315796|"     Pain is a common and difficult problem for patients with cancer. It has been reported that     over 80% of cancer patients suffer from pain. Much of this pain is iatrogenic and related to     procedures. Dr. Grossman recently demonstrated that most patients undergoing bone marrow     biopsy have poor pain control during the procedure. Treatment of pain is almost entirely with     analgesic medications, principally opioids. These medications have numerous undesirable     effects such as sedation, confusion, hypotension and constipation that limit their efficacy     and utility. Drs. Diette, Lechtzin, Rubin and colleagues recently demonstrated that use of     nature sights and sounds (NSS), a simple, safe, and inexpensive intervention, decreases pain     during fiberoptic bronchoscopy, a procedure commonly performed to diagnose cancer and to     detect pulmonary complications of cancer therapy. Patients were randomly assigned to either     standard care with intravenous narcotics and benzodiazepines or standard care coupled with     view of a nature scene and use of nature sounds before, during, and after bronchoscopy. The     group assigned to the NSS reported significantly better pain control than the control group.     While these findings are novel and exciting, they raised several new questions that suggest     logical extensions of this work. It is not known whether this intervention can be applied to     patients in other settings, nor is it known whether comparison to standard care is an     appropriate control group. Further, the mechanism of action of NSS needs to be determined.     NSS may simply be a form of distraction therapy but it may have other properties. The theory     of biophilia proposes there are specific elements in nature imagery that exert beneficial     health effects. Because NSS appears to be a promising and safe intervention for the treatment     of pain, these investigators plan to perform a controlled clinical trial in cancer patients     undergoing invasive procedures. Patients will be randomly assigned to one of three arms,     standard care, NSS, and a non-nature based distraction technique. We will study the efficacy     of NSS for the management of procedure-related pain in oncology patients. The findings will     provide necessary background information to develop more definitive studies of NSS that     should be competitive for external funding. This exciting study will help develop a harmless,     inexpensive method to treat pain in cancer patients, that may complement or replace analgesic     medications.   "
189232|NCT00315809|"     The purpose of the study is to see if new methods can be used to determine why Multidrug     Therapy (MDT), used to cure leprosy patients effectively for twenty years, is not as     effective against Leprosy in the Philippines. Researchers do not know how people get infected     with leprosy or what causes the disease to relapse after cure with adequate MDT. Blood, skin     scrapings, nasal swabs and biopsies, will be collected from leprosy patients to perform tests     related to the detection of the disease and the germ. The tests will be used to find out if     the bacteria in the body are related to the bacteria found in other patients or contacts.     This will help the researchers to know where these bacteria come from, and to see how they     spread. Other tests will be performed to see if the bacteria can be killed by two common     medicines given to leprosy patients. Study participants will include individuals age 18 and     older presenting to Leonard Wood Memorial for the diagnosis and/or relapse of leprosy.   "
189234|NCT00315835|"     The objective of this study is to assess the safety of the buprenorphine transdermal system     (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to     severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72     hours during which time supplemental analgesic medication (intravenous morphine PCA) will be     provided to all subjects in addition to study drug.   "
189235|NCT00315848|"     The objective of this study is to demonstrate the effectiveness and tolerability of the     buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal     system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain     inadequately treated with non-opioid analgesics. The double-blind treatment intervention     duration is 60 days.   "
189236|NCT00315861|"     Currently, no data exists regarding the safety and tolerability of a combination regimen     utilizing weekly topotecan in combination with pemetrexed. Although both drugs are associated     with myelosuppression, it is hoped that the utilization of the weekly topotecan dosing     schedule will allow the drugs to be easily combined. This phase I trial will evaluate the     safety and tolerability of weekly topotecan in combination with pemetrexed in patients with     advanced solid tumors.   "
189237|NCT00315874|"     The objective of this study is to demonstrate the effectiveness and tolerability of the     buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal     system and immediate release oxycodone/acetaminophen in subjects with chronic low back pain     inadequately treated with non-opioid analgesics. The double-blind treatment intervention     duration is 60 days.   "
189238|NCT00315887|"     The objective of this study is to assess the safety and efficacy of the buprenorphine     transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and     hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment     intervention duration is 56 days during which time supplemental analgesic medication     (ibuprofen) will be provided to all subjects in addition to study drug.   "
189239|NCT00315900|"     The primary objective of the study is to assess the relative efficacy of Depakote ER and     Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a     Department of Veterans Affairs (VA) nursing home care unit (NHCU). The secondary objective of     the study is to assess the relative tolerability of Depakote ER and Seroquel in this     population. The primary hypothesis is that agitated dementia patients will demonstrate a     significantly greater reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores while     treated with Depakote ER compared to treatment with Seroquel.   "
189240|NCT00315913|"     The purpose of this study is to determine whether propranolol is better than oxytocin for the     treatment of labor abnormalities. The endpoint is the rate of vaginal delivery experienced by     women receiving prolonged oxytocin versus propranolol.   "
189241|NCT00315926|"     The purpose of this study is to assess whether treatment with melatonin can reduce cell     damage and inflammatory stress response and thereby occurrence of myocardial injury after     abdominal aortic surgery.   "
189242|NCT00315939|"     The purpose of this study is to test two newly developed computer programs, Integrated     Biobehavioral Monitoring and Feedback (IBMF) IBMF-1 and IBMF-2. The computer programs are     considered experimental. Both computer programs are being tested to see if they are useful in     helping people with type 1 diabetes avoid low blood sugar episodes.   "
189243|NCT00315952|"     University of Pittsburgh Medical Center (UPMC) diabetes research physicians are studying the     action in muscle tissue of inhaled insulin (Exubera®) and infused (intravenous or IV)     insulin on blood sugar control in people with type 1 diabetes. Type 1 diabetics often take     2-4 shots of insulin every day. Exubera may offer an alternative to these insulin injections.   "
189244|NCT00315965|"     Using a rapidly responding nitric oxide analyzer in a new developed modular     lung-function-setup we are going to measure steady-state NO diffusing capacity in 107 healthy     subjects (age 6-45 years). The results will be compared to those measured by using carbon     monoxide single-breath estimates. We like to show that the new method is sufficient to     measure exactly lung diffusion capacity in this collective.   "
189245|NCT00315978|"     The purpose of this study is to determine whether providing patients with information about     their global coronary heart disease (CHD) risk and effective risk-reducing strategies allows     them to make appropriate decisions about heart disease prevention.   "
189246|NCT00315991|"     The purpose of this study is to test a training program for parents of children with T1DM.   "
189247|NCT00316004|"     The purpose of this study is to determine if hypertonic saline with and without dextran can     improve neurologic outcomes in victims of severe traumatic brain injury (TBI).      Injury and lost blood from trauma can cause your body to go into shock (low blood pressure     related to blood loss). This decreased blood flow can lead to organ damage. In order to     restore the blood pressure and blood flow, the medics give fluids into the patients' veins as     soon as possible. This is called resuscitation. The fluid most commonly used is isotonic     or one that is the same salt concentration as the blood. The investigators are trying to     determine if infusing a hypertonic fluid or one more concentrated than the blood can     increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids     they are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no     dextran). Hypertonic saline is a salt solution that is slightly more concentrated than blood.     Dextran is a sugar solution.   "
189248|NCT00316017|"     The purpose of this study is to determine if hypertonic saline with and without dextran can     improve overall survival in victims of trauma with shock.      Injury and lost blood from trauma can cause your body to be in shock (low blood pressure     related to blood loss). This decreased blood flow can lead to organ damage. In order to     restore the blood pressure and blood flow, the medics give fluids into the patients' veins as     soon as possible. This is called resuscitation. The resuscitation fluid most commonly used     is isotonic or one that is the same concentration as the blood. The investigators are     trying to determine if infusing a hypertonic fluid (or one more concentrated than the     blood) can increase the blood pressure and restore blood flow more efficiently. The     hypertonic fluids the investigators are using are called hypertonic saline with dextran (HSD)     and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly     more concentrated than your blood. Dextran is a sugar solution.   "
189249|NCT00316030|"     Bexarotene may be useful in the treatment of Acute Myeloid Leukemia (AML). This is the first     study on the use of bexarotene to treat patients with AML. The main purpose of this study is     to establish the proper dose of bexarotene when used to treat AML. The side effect profile of     bexarotene in patients with AML will also be explored.   "
189250|NCT00316043|"     The aim of the study is to describe the current clinical management of young children with     urinary tract infections in Dutch primary care and also to describe the possibilities for     improvement and potential cost-efficiency of improved care in the light of preventing renal     failure.   "
189251|NCT00316056|"     This study will investigate how people learn best about genetics. It involves participating     in activities in NHGRI's Immersive Virtual Environment Laboratory (IVE lab), where digital     virtual worlds are created that appear to surround the subject when he or she wears a     head-mounted display.      English-speaking men and women between 18 and 40 years of age may be eligible for this study.     Participants are randomly assigned to one of two groups, each of which receives a different     type of information, once in the IVE lab. Subjects complete a questionnaire before and after     performing the activities in the lab. The questionnaire evaluates the subject's knowledge of     genetics and tests some reading and number skills.   "
189252|NCT00316290|"     This study will determine the effectiveness of integrated parent training versus standard     behavioral parent training in treating depression and stress in mothers of children with     attention deficit hyperactivity disorder (ADHD).   "
189253|NCT00316303|"     This study will determine the effectiveness of the STIRR (Screen, Test, Immunize, Reduce     risk, and Refer) intervention in increasing rates of testing, immunization, referral, and     treatment for blood-borne diseases, such as hepatitis and HIV, in people with both a mental     disorder and a substance abuse disorder.   "
189254|NCT00316316|"     This study will determine the effectiveness of adding motivational interviewing to cognitive     behavioral therapy, consisting of exposure and ritual prevention, in improving treatment     outcomes in people with obsessive-compulsive disorder.   "
189255|NCT00316329|"     Primary Objective:        -  To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on          D28 of administration of Coarsucam™ (artesunate+amodiaquine fixed-dose combination), as          a single daily dose, in comparison with administration of Coartem®          (artemether+lumefantrine).      Secondary Objectives:      To compare the 3 treatment groups in terms of:        -  clinical and parasitological efficacy on D14 and D28 on the global population and on the          subpopulation consisting of children aged under 5 years and that for patients aged 5          years and over        -  clinical and laboratory safety        -  time to parasite clearance        -  time to clearance of fever        -  changes in gametocytaemia        -  impact on anaemia   "
189256|NCT00316342|"     The purpose of this study is to examine the effect of back supports plus education upon     recovery from a work-related low back disorder. The study tests the hypothesis: the use of     back supports plus health education is not different from health education alone in promoting     recovery from a work-related low back disorder in consideration of personal, health, and job     factors. Significant improvements in physical health, neurogenic symptoms, back pain     disability, and low back pain were observed over the twelve months of study follow-up. No     statistically significant difference between the study groups was found with respect to these     measures.   "
189257|NCT00316355|"     This study will determine the effectiveness and cost-effectiveness of a stepped-care     treatment program for people with obsessive-compulsive disorder.   "
189318|NCT00317148|"     The purpose of the study is to evaluate the effect of daily oral intake of DHEA 50 mg for 4     months on reducing vasomotor symptoms (hot flashes) compared to placebo administration in     postmenopausal women.   "
189258|NCT00316368|"     The purpose of this study is to determine, using echocardiography, whether bi-ventricular     pacing improves the contractile force by resynchronizing both ventricles, thereby improving     and/or correcting the paradoxical septal movement.      Primary Hypothesis:        -  Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in          cardiac index (CI) as compared with standard atrio-right ventricular pacing.      Secondary Hypothesis:        -  Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in          cardiac index (CI) as compared with atrio-left ventricular pacing and right atrium          pacing.   "
189259|NCT00316381|"     The purpose of the study is to compare the efficiency of a sorted subpopulation of     CD34+/CXCR4+ cells and unselected bone marrow-derived progenitor cells in the treatment of     patients with acute myocardial infarction and a low left ventricular ejection fraction.   "
189260|NCT00316394|"     To determine the effectiveness of a single checklist reminder form to improve the delivery of     preventive health services at adult health check-ups in a family practice setting.   "
189261|NCT00316407|"     The purpose of this study is to determine the effectiveness, safety, tolerability and best     dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.   "
189262|NCT00316420|"     The purpose of this study is to test the effectiveness and safety of the drug combination of     gemcitabine and capecitabine (Xeloda) in patients with advanced pancreatic cancer.   "
189263|NCT00316433|"     The purpose of this study is to determine the safety and effectiveness of the combination of     oxaliplatin and irinotecan (CPT-11) in patients with previously untreated, advanced small     cell lung cancer.   "
189264|NCT00316446|"     The purpose of this study is to determine if gastric bypass patients experience     hypoventilation in the immediate postoperative period, and to what degree.   "
189265|NCT00316459|"     To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as     assessed by the QTc interval.   "
189266|NCT00316472|"     Elevated phosphorus levels are a common problem in dialysis patients. However, it is     associated with an increase in death and hospitalizations. Current treatment is comprised of     dietary modifications and phosphorus binders - though this is often not enough for many of     our patients. Our trial investigates the use of niacinamide, a form of vitamin B, in     decreasing serum phosphorus levels.   "
189305|NCT00316979|"     Migraine is a condition thought to be related to cortical hyperexcitability. Repetitive     transcranial magnetic stimulation (rTMS) can modulate the cortical excitability by means of     long-term potentiation or long-term depression. This study will will test the safety and     efficacy of rTMS in the treatment of patients with Migraine.   "
189267|NCT00316485|"     Under this study, patients who require removal of their third molars (wisdom teeth) will be     diagnosed, evaluated and treated. In addition, tooth, bone and gum tissue samples will be     collected for use in bone, wound healing, microbiology and genetic research.      Patients 16-50 years of age who require wisdom tooth removal may be eligible for this study.     Participants may have one or all of their wisdom teeth removed at one time. The surgery is     done under local anesthetic. In addition, conscious sedation may be administered, if the     patient wishes.      Besides wisdom tooth removal, patients are asked to donate a small sample of jaw bone (from     the lining of the inner wall of the tooth socket) and gum tissue (from the area of the     surgical site). The samples are collected at the same time as the tooth extraction. The bone     sample is about the size of a pencil point (1.5 millimeters wide and 3 millimeters long) and     the gum tissue sample is 1 millimeter. Removal of these samples should not cause any     additional discomfort or increase the time required for the surgery or for healing.   "
189268|NCT00316498|"     This study is done in conjunction with a trial, conducted at Columbia University College of     Physicians and Surgeons in New York and the Royal Manchester Children's Hospital in England,     to examine the effectiveness of a new drug called OGT 918 for treating Niemann-Pick Type C     (NPC) disease. Patients with this genetic disorder do not transport lipids (fatty substances)     in their cells, resulting in problems of the liver, spleen and brain. An early sign of NPC is     a reduced ability to move the eyes rapidly up and down or from side to side. These voluntary     eye movements are called saccades. Patients in the OGT 918 trial who participate in this     sub-study will have their saccadic eye movements measured to see if improvement occurs with     OGT 918 treatment.      Patients with Niemann-Pick Type C disease 12 years of age and older who are enrolled in the     OGT 918 trial described above may be eligible for this study.      Participants will have both vertical (up and down) and horizontal (side to side) saccadic eye     movements measured at two time points before starting treatment with OGT 918 and after 12     months of treatment. For the test, patients sit in a chair with their head positioned as for     a regular eye examination (steadied by a chin cup and headrest) and follow with their eyes a     series of lights or laser spots moving on a screen at a distance of 1 meter (3 feet). During     the test, patients wear either special recording glasses, infrared goggles, or special     contact lenses for measuring eye movements. A full eye evaluation lasts about 1 hour, and     each eye is evaluated twice. The evaluations are separated in time by at least an hour, and     possibly a day.   "
189269|NCT00316511|"     This is a dose escalation study. Patients will be enrolled in cohorts of three patients each,     and escalation of dose to the next cohort will be determined based on dose-limiting toxicity     (DLT) in the previous cohort. This study aims to identify the maximum tolerated dose (MTD) of     intravenous L-NDDP. Once the MTD has been determined, an additional four patients will be     enrolled at that dose level. While the MTD is determined based on safety data from each     cohort's first cycle of L-NDDP therapy only, patients may continue treatment with additional     cycles of L-NDDP at the same dose as their starting dose until documented progression,     unacceptable toxicity, or another off study criterion is met. Patients who have not met any     of the off study criteria and continue to receive L-NDDP therapy at the time when MTD is     determined may be allowed to change L-NDDP dose to the MTD dose level. The study will also     determine the pharmacokinetic profile of L-NDDP administration. Clinical activity of L-NDDP     in solid tumor patients will be assessed as tumor response using the Response Evaluation     Criteria in Solid Tumors (RECIST) criteria. Clinical activity of L-NDDP in B-cell lymphoma     patients will be assessed using the International Working Group recommendations.   "
189270|NCT00316524|"     The primary objective of this study is to evaluate the immune response after a single     vaccination of pre-immune subjects compared to two vaccinations in naive subjects.      In addition the study further investigates the safety profile of MVA-BN® in a healthy     population compared to placebo.   "
189271|NCT00316537|"     The purpose of this study is to evaluate the safety and preliminary efficacy of low dose     nicotine gel in patients with chronic diabetic ulcers   "
189274|NCT00316576|"     Associations between angiotensin-converting enzyme gene polymorphism and occurrence and     outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already     been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the     I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be     associated with a higher risk of acute renal failure in critically ill patients.   "
189275|NCT00316589|"     The purpose of this study is to gather information on the safety and immunogenicity of an     investigational smallpox vaccine in HIV infected populations. Subjects will receive two     vaccinations   "
189276|NCT00316602|"     The purpose of this study is to compare the immunogenicity and safety of an investigational     smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.   "
189277|NCT00316615|"     The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular     (IM) injection of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006,     when Administered to Non-Elderly Adults and Elderly Subjects   "
189278|NCT00316628|"     The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular     (IM) injection of an adjuvanted influenza vaccine in elderly subjects.   "
189279|NCT00316641|"     The purpose of this study is to determine whether the Lipid-lowing Tea is effective and safe     in the treatment of Hyperlipidemia Patients   "
189280|NCT00316654|"     Persistence of Antibody Response to N. meningitidis Group C in Children   "
189281|NCT00316667|"     The aim is to assess the population prevalence of risk factors for different chronic diseases     such as cardiovascular disease, type 2 diabetes, osteoporosis, asthma, and allergy. Risk     factors include genetic and serologic biomarkers, questionnaire data on health and lifestyle.     There are many hypotheses under study for each research field.   "
189282|NCT00316680|"     A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK     Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis     B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories     (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b     vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be     assessed as well.   "
189283|NCT00316693|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the     uterus or womb). This infection may go away by itself, but if it does not go away (this is     called persistent infection), it can lead in women over a long period of time to cancer of     the cervix. This study will evaluate the efficacy in prevention of persistent HPV-16 or     HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK     Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 -     25 years of age at study start. Approximately 1000 study subjects will either receive the HPV     vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to     a 0-1-6 month schedule.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
189284|NCT00316706|"     This protocol posting deals with objectives & outcome measures of the extension phase up to     Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of     the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by     enzyme-linked immunosorbent assay (ELISA). The objectives & outcome measures of the primary     phase are presented in a separate protocol posting (NCT00196924).      The long-term follow-up study will be blinded until the primary study is unblinded and will     be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924).     During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the     primary study will continue their participation in the follow-up study until Month 48.     Subjects in the Control group (Havrix®) will attend one further visit as their last study     visit.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
189285|NCT00316719|"     This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with     lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week     periods.   "
189286|NCT00316732|"     This study was designed to assess the effectiveness of dutasteride in the actual clinical     practice of prostate assessment clinics in the UK in accordance with best practice over a     12-month period.   "
189287|NCT00316745|"     This randomized phase III study compares safety and efficacy of two sequence arms in advanced     colorectal cancer: irinotecan and S-1 (IRIS) followed by oxaliplatin containing regimen (arm     A), or l-leucovorin (l-LV), 5-FU and oxaliplatin (mFOLFOX6) followed by irinotecan containing     regimen (arm B).   "
189288|NCT00316758|"     This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses     ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in     patients with type 2 diabetes. Eligible patients will be those who have completed study     BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will     continue on the same treatment regimen (mono or combination therapy) as they received in the     initial study. The anticipated time on study treatment is 3-12 months, and the target sample     size is 100-500 individuals.   "
189289|NCT00316771|"     This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor     (4) in patients with RA currently having an inadequate clinical response to methotrexate.     Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75     bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time     on study treatment is <3 months, and the target sample size is 100-500 individuals.   "
189290|NCT00316784|"     The study objective is the eluciation of the dose-response function in efficacy (and possibly     safety) in order to determine an optimal dose with respect to efficacy and safety. The study     is designed with three dose levels and one placebo control.   "
189331|NCT00317317|"     Infertility is a common problem with increased incidence. In-vitro fertilization (IVF) is by     far the most commonly used treatment. The success rate of IVF is still low. This study     examines the effect of acupuncture on IVF pregnancy rate, as well as possible mechanisms. It     is hypothesized that acupuncture can significantly increase the IVF pregnancy rate.   "
189291|NCT00316797|"     The initial study of [123I] INER will be completed in two parts. Once Part A (Preliminary     whole body biodistribution) is completed, Part B (Serial dynamic SPECT assessment of regional     brain uptake and washout and plasma metabolite analysis to determine the brain penetrance and     regional distribution and washout counts following 123-I INER injection) will commence. All     study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and     Molecular NeuroImaging (MNI) in New Haven, CT. All subjects will undergo written informed     consent and a screening evaluation including baseline clinical laboratory testing, and a     baseline physical and neurological evaluation.   "
189292|NCT00316810|"     The purpose of this study is to determine and compare the efficacy of Campath-1H/Tacrolimus     versus ATG/Tacrolimus/MMF therapy in conjunction with initial short-term steroids in Type     1-diabetic patients undergoing simultaneous pancreas-kidney allograft transplantation as well     as to evaluate the safety of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF in terms of     drug-related complications and immunosuppression-associated complications.   "
189293|NCT00316823|"     RATIONALE: Finding genetic markers for thyroid cancer in a biopsy specimen may help doctors     diagnose thyroid cancer.      PURPOSE: This clinical trial is studying how well genetic analysis works in diagnosing     thyroid cancer in patients with thyroid nodules.   "
189294|NCT00316836|"     RATIONALE: Understanding the relationship between breast density, levels of hormones in the     blood, and levels of anticancer drugs in the blood may help improve the ability to plan     effective treatment for women with invasive breast cancer.      PURPOSE: This clinical trial is studying the relationship between breast density and blood     levels of hormones and anticancer drugs in women with invasive breast cancer who are     receiving exemestane or anastrozole.   "
189295|NCT00316849|"     This phase I trial is studying the side effects and best dose of temsirolimus when given     together with temozolomide and radiation therapy in treating patients with newly diagnosed     glioblastoma multiforme. Temsirolimus may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     temsirolimus together with temozolomide and radiation therapy may kill more tumor cells.   "
189296|NCT00316862|"     This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together     with radiation therapy works in treating patients with esophageal cancer or gastroesophageal     junction cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin     and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with     radiation therapy before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed.   "
189297|NCT00316875|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride     liposome work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving lapatinib together with doxorubicin     hydrochloride liposome may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of doxorubicin     hydrochloride liposome when given together with lapatinib in treating patients with     metastatic breast cancer.   "
189298|NCT00316888|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,     such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Cetuximab may help cisplatin and fluorouracil work     better by making tumor cells more sensitive to the drugs. It may also make tumor cells more     sensitive to radiation therapy. Giving cetuximab together with chemotherapy and radiation     therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin,     fluorouracil, and radiation therapy works in treating immunocompetent patients with stage I     (closed to accrual as of 11/3/2008), stage II, (some stage II closed to accrual as of     11/3/2008) or stage III anal cancer.   "
189299|NCT00316901|"     RATIONALE: Diagnostic procedures, such as positron emission tomography and computed     tomography scan (done before and after cellular adoptive immunotherapy), may help doctors     predict a patient's response to treatment and help plan the best treatment.      PURPOSE: This phase II trial is studying how well positron emission tomography and computed     tomography scan predicts response in patients with metastatic melanoma or kidney cancer who     are undergoing cellular adoptive immunotherapy on a Surgery Branch clinical trial.   "
189300|NCT00316914|"     RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused     by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more     effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients     receiving combination chemotherapy.      PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate     to see how well they work compared to a placebo in preventing neurotoxicity caused by     oxaliplatin in patients receiving combination chemotherapy for stage II, stage III, or stage     IV colorectal cancer that has been completely removed by surgery.   "
189301|NCT00316927|"     RATIONALE: Giving dexamethasone together with aspirin and diethylstilbestrol may be effective     in lowering prostate-specific antigen levels and may slow or stop the growth of prostate     cancer. It is not yet known which schedule of dexamethasone, aspirin, and diethylstilbestrol     is more effective in treating prostate cancer.      PURPOSE: This randomized phase III trial is studying dexamethasone and aspirin when given     together with two different schedules of diethylstilbestrol to compare how well they work in     treating patients with locally advanced or metastatic prostate cancer.   "
189347|NCT00317525|"     The aim of this study is to examine the relationship between optical blur from poor     refractive corrections (glasses) of older workers using computers and their productivity and     comfort in the workplace. The investigators believe that improving the visual status of     subjects who use computers will have a beneficial effect on productivity and visual comfort.   "
189302|NCT00316940|"     RATIONALE: Radioactive substances, such as samarium 153, may release radiation as it breaks     down and kill cancer cells. Bortezomib may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth. Bortezomib may also make tumor cells more sensitive to     radiation. Giving samarium 153 together with bortezomib may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of samarium 153 when     given together with bortezomib in treating patients with relapsed or refractory multiple     myeloma.   "
189303|NCT00316953|"     This phase I trial is studying the side effects and best dose of dasatinib in treating young     patients with recurrent or refractory solid tumors or Philadelphia chromosome-positive acute     lymphoblastic leukemia or chronic myelogenous leukemia that did not respond to imatinib     mesylate. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth   "
189304|NCT00316966|"     With the introduction of the National Insurance Law in Israel in 1995, there have been     increased efforts to reduce hospitalization in general and length of stay in the hospital in     particular. Under nourished patients have been shown to have a longer mean length of stay and     they are more likely to suffer from complications, which significantly increase cost of care.     Intense nutritional intervention programs, aimed at decreasing rehospitalizations and post     hospitalization complications, are not clearly currently included in the basket of services     provided under the law. Nutritional intervention has been shown to be clinically efficacious     and cost-effective. Demonstration of the benefits of such intervention, both in terms of     reduced expenditures and quality of care, may open a path for specific nutritional     intervention programs that are needed for older persons during and after discharge from Acute     Care. Given the effort made to reduce the length of hospitalization time, even in frail     elderly patients, it is clear that full scale nutritional intervention cannot be completed     during their hospitalization. Therefore, there is a need to create continuity between     in-patient and follow-up nutritional intervention. This combined policy has the potential to     improve general health, reduce the rates of under nutrition and its associated complications,     and thus reduce future hospitalization, along with the mortality and morbidity associated. It     is plausible that improved general health and less frequent hospitalization will eventuate in     cost reduction and allow the intervention to be cost effective. Furthermore, the descriptive     information regarding the nutritional status of older patients admitted to an Acute Care     department may be important for policy makers in their development of nutritional     intervention programs to support the elderly before, during and after hospitalization.      Study Hypothesis:      We hypothesize that multidisciplinary nutritional intervention, during and following     hospitalization, will improve dietary intake and nutritional status. Improvement in     nutritional status will, in turn, cut health care costs by decreasing the use of health     services. In-hospital nutritional care will be beneficial, but combined in-hospital and     community care will be more clinically efficacious and more cost effective in the long run.   "
189306|NCT00316992|"     The purpose of this study is to determine if ramelteon has respiratory depressant effects in     subjects with moderate to severe chronic obstructive pulmonary disease.   "
189307|NCT00317005|"     Homocysteine recently gained access to the category of risk factor for the development of     atherosclerotic cardiovascular disease in the general population. Chronic renal failure     patients, even before being introduced to dialysis therapy have almost universal elevation of     serum homocysteine; when on dialysis their mortality is above 50% related to cardiovascular     disease that we might now speculate, with a contribution of potentially toxic levels of the     aminoacid homocysteine.   "
189308|NCT00317018|"     Small contract VA Community Based Outpatient Clinics present unique challenges to     implementation of collaborative care because of their distinct organizational characteristics     and lack of on-site psychiatrists. A recent effectiveness study, successfully used     telemedicine technologies to adapt the collaborative care model for small rural VA Community     Based Outpatient Clinics. The purpose of the proposed study is to implement this     telemedicine-based collaborative care model in small Contract VA Community Based Outpatient     Clinics and determine its sustainability and cost-effectiveness.   "
189309|NCT00317031|"     The primary objective is to directly compare the efficacy of acamprosate, naltrexone and     placebo for relapse prevention in alcoholics.   "
189310|NCT00317044|"     The purpose of this study is to determine whether treatment with esomeprazole for 6 months     will improve asthma in adult patients with moderate to severe asthma and symptoms of     gastroesophageal reflux disease.   "
189311|NCT00317057|"     Patients admitted to the hospital with chronic obstructive pulmonary disease are evaluated     with regard to early follow-up by a specialized nurse in the home after discharge.   "
189312|NCT00317070|"     The primary objective of this study is to evaluate the efficacy and tolerability of the     intravesical cocktail and its comparison with intravesical DMSO in a controlled trial for the     treatment of painful bladder syndrome including interstitial cystitis.   "
189313|NCT00317083|"     Up to 70% of obese patients undergoing bariatric surgery have obstructive sleep apnea     syndrome (OSAS). OSAS is responsible for laryngeal sensory impairment. As the afferent neural     pathway involved in the initiation of cough is located in the laryngeal epithelium, cough     reflex sensitivity may be decreased in obese OSAS patients. The researchers therefore     conducted this study to determine the effect of OSAS associated with obesity on cough reflex     sensitivity, assessed by cough reflex threshold to an inhaled irritant (citric acid).   "
189314|NCT00317096|"     The aim of this phase III trial is to assess the safety and efficacy of treatment with     rituximab in combination with FCM chemotherapy (R-FCM) versus FCM chemotherapy alone for     remission induction and to asses the safety and efficacy of rituximab maintenance versus     observation only after response to induction therapy. Both questions are addressed in way of     a prospective randomized comparison in patients with relapsed FL, MCL and LP lymphoma.   "
189315|NCT00317109|"     The purpose of this study is to assess the safety and reactogenicity of a booster dose of     diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b     vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and     reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal     vaccine (ACW) at 24 to 30 m in primed subjects.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
189316|NCT00317122|"     This study will only include infants born to mothers who are tested as seronegative for human     immunodeficiency virus (HIV) & hepatitis B surface antigen (HBsAg). The purpose of this study     is to demonstrate in infants who received a birth dose of hepatitis B vaccine that     Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with     respect to immunogenicity of the hepatitis B antigen.   "
189317|NCT00317135|"     The purpose of this study is to compare the reactogenicity & safety of     Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care,     Tritanrix™-HepB/Hiberix™.   "
189319|NCT00317161|"     The purpose of the study is to demonstrate consistent results in 3 production lots of     Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a     single injection, with respect to immunogenicity, safety and reactogenicity.     Tritanrix™-HepB/Hiberix™ given alone and Wyeth Lederle's meningococcal C conjugate vaccine     (Meningitec™), given concomitantly with Tritanrix™-HepB/Hiberix™ will be used as benchmark     vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.   "
189320|NCT00317174|"     The purpose of the study is as follows:        -  To evaluate the persistence of antibodies and the presence of immune memory induced by a          3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the          study DTPwHB/HibMenACTT001 (CPMS No. 759346/001) by giving unconjugated PRP, PSA and PSC          at 10 months age to one subset of subjects.        -  To evaluate the persistence of all antibodies pertaining to primary vaccination and the          booster response to Tritanrix™-HepB/Hib2.5 vaccine or Tritanrix™-HepB/Hib-MenAC vaccine          at 15-18 months age in the other subset of subjects.   "
189321|NCT00317187|"     The purpose of this study is to compare the reactogenicity & safety of     Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care,     Tritanrix™-HepB/Hiberix™.   "
189322|NCT00317200|"     Improvements in therapy for relapsed SCLC are much needed. Paclitaxel has been previously     tested and found to have significant single agent activity in relapsed SCLC, including in     refractory patients. Angiogenesis plays an important role in SCLC, increased VEGF levels are     associated with worse outcomes. Bevacizumab, a monoclonal antibody to VEGF, increase response     rates and survival when combined with chemotherapy agents compared with the chemotherapy     agent alone in NSCLC, breast cancer, and colorectal cancer. Paclitaxel plus bevacizumab, in     the dose and schedule proposed in this study, improves response rates and progression free     survival compared with paclitaxel alone in women with metastatic breast cancer. Therefore, we     will be testing the safety, feasibility, and efficacy of this regimen in patients with     chemosensitive relapsed SCLC.   "
189323|NCT00317213|"     It has been shown in rodent models that chronic substance abuse is associated with a     rigidification of cell membrane fluidity due to a change in the membrane     cholesterol/phospholipids ratio. Upon substance withdrawal the membrane undergoes     reequilibration of this ratio, a process resulting both in an acute and a prolonged severe     withdrawal syndrome. MBM has developed a patented,phosphatidic acid-enriched phospholipid     platform (LIBERTAL), which is supposed to facilitate the membrane fluidity recovery. The     company has focused on nicotine withdrawal in smoking cessation,as primary target.   "
189324|NCT00317226|"     The primary objective of this study is to evaluate the long term safety and tolerability of     an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of     non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension     to protocol 1VIT04004 (NCT00317239).   "
189325|NCT00317239|"     This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron     (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with     non-dialysis dependent chronic kidney disease (NDD-CKD).   "
189326|NCT00317252|"     The purpose of this study is to determine if patients should stop taking their angiotensin     converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) around the time of     their angiogram in order to prevent contrast induced nephropathy (CIN).   "
189327|NCT00317265|"     This is a randomized, prospective European Multicenter Study comparing complete arterial     revascularization of the coronary arteries using arterial graft material exclusively and     “conventional” coronary artery bypass surgery using the left internal thoracic artery as     graft to the left anterior descending artery (LAD) and vein grafts to other vessels to be     bypassed.   "
189328|NCT00317278|"     Infants in the Neonatal Intensive Care Unit (NICU) are exposed to stressful stimuli such as     loud noises, bright lights, blood drawing, suctioning, and intubation, and are frequently     left in isolation with minimal proper interaction. Stress has been demonstrated to exert a     negative effect on the immune system. Different psychological interventions, including     relaxation, have been used in efforts to reduce stress, and several of these techniques have     been shown to improve cellular immunity. Massage therapy (MT) has been used to reduce stress     in premature infants and has been associated with weight gain, shorter hospital stay, and     improvement in mental/motor development. While MT has been shown to increase the number and     function of natural killer (NK) cells in healthy adults and in adults infected with HIV, the     effect of MT on the immune system of children, including premature infants, has never been     investigated. The investigators hypothesize that, in premature infants, MT will enhance the     immune system. One hundred and twenty stable premature infants meeting selection criteria     will be randomized to massage and sham treatment groups. Immunologic evaluation will be     performed on both groups at baseline, midway and at the end of therapy. Physicians, nurses,     and parents will be masked. The investigators' unique and innovative study will be the     largest study in this area and will provide valuable information on potential immune     parameters associated with stress reduction and improved development in premature infants     undergoing massage therapy.   "
189329|NCT00317291|"     This is a sample-size-limited, randomized, blinded (subject and evaluator), sham     acupuncture/placebo moxibustion (sham acu/placebo moxa) controlled clinical trial. The     subjects in this study will be 50 men and women with HIV infection who have a diagnosis of     distal symmetric peripheral neuropathy (DSP). Subjects will be randomized to one of two     experimental intervention conditions:        -  Condition 1: subjects receive acu/moxa treatment; and        -  Condition 2 (Control Group): subjects receive sham acu/placebo moxa.      All subjects in Conditions 1 and 2 will attend 16 scheduled sessions over 15 weeks, be     administered the same instruments, and submit their daily symptom diaries for analysis. There     will be six weeks of twice weekly treatment sessions, and three follow-up sessions at weeks     9, 11, and 15. All conditions will be identical in duration and be administered by licensed     acupuncturists trained in traditional Chinese medicine (TCM).   "
189330|NCT00317304|"     Stress appears to be related to hot flash frequency and intensity, and the degree of distress     that women experience from their hot flashes appears to be related to their coping resources.     This trial is a pilot study to test the effect of participation in a mindfulness-based stress     reduction program on hot flash frequency and intensity, as well as menopause-related quality     of life.   "
189332|NCT00317330|"     This study will test the effectiveness of two different tuberculosis (TB) prevention     strategies, DOTS or DOTS-A. DOTS is the current prevention strategy for TB. DOTS-A is an     enhanced prevention strategy that will screen household members of individuals diagnosed with     active TB and will provide enhanced treatment as needed. The study will be conducted in 8     communities located in Rio de Janeiro. Study participants will include 6400 males and females     of all ages, including active TB patients and their household contacts. Patients with TB     identified for treatment at the Health Clinics of 8 urban communities will be eligible. The     communities will be assigned to 1 of the 2 prevention strategies, DOTS or DOTS-A. After 4     years, the information gathered during the study will be used to determine the incidence of     TB in these communities to see which prevention strategy was more effective in decreasing TB.   "
189333|NCT00317343|"     RIAPRE is a non-interventional registry to be settled in Italy with the purpose of collecting     data on 600 cases of high risk elective percutaneous coronary intervention (PCI) patients     treated with an anticoagulation regime different from unfractionated heparin in monotherapy.     About thirty catheterization laboratories will co-operate in this activity. The long term     outcome of patients will be taken into consideration. The availability of these data will     allow for a better understanding of the therapeutic needs in this area.   "
189334|NCT00317356|"     The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and     to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for     8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients     with active ulcerative colitis.   "
189335|NCT00317369|"     The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its     optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination     with a fixed oral dose of 5-aminosalicylic acid (5-ASA) or in combination with a fixed oral     dose of 5-ASA and enteral nutrition in patients with active Crohn's disease.   "
189336|NCT00317382|"     Does the use of ultrasound facilitate a lumbar puncture by reducing the number of difficult     and traumatic lumbar punctures?   "
189337|NCT00317395|"     Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5     intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute     coronary syndromes (ACS) and planned early invasive strategy.      Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and     pharmacodynamics (PD).   "
189918|NCT00324974|"     The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules     oral suspension, once daily (QD), in infants with gastroesophageal reflux symptoms during a     4-week treatment period.   "
189338|NCT00317408|"     RATIONALE: Giving combination chemotherapy and total-body irradiation before a peripheral     stem cell transplant that uses the patient's or a donor's stem cells, helps stop both the     growth of cancer cells and the patient's immune system from rejecting the stem cells. When     the stem cells are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy and     total-body irradiation followed by a stem cell transplant may be an effective treatment for     anaplastic large cell lymphoma.      PURPOSE: This clinical trial is studying how well combination chemotherapy followed by stem     cell transplant works in treating young patients with progressive or relapsed anaplastic     large cell lymphoma.   "
189339|NCT00317421|"     The purpose of the study is to investigate if regular treatment with sildenafil reduces blood     pressure and improves blood vessel function in patients with hypertension (high blood     pressure).   "
189340|NCT00317434|"     The purpose of this study is to determine the maximum tolerated dose of Lapatinib with     Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal     carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with     carboplatin AUC 6 in this cohort of patients.   "
189341|NCT00317447|"     Sciatica (lumbosacral radiculopathy) is a common diagnosis in primary care, occurring in     approximately one percent of all patients with acute low back pain. (1, 2) Traditional     treatment generally involves pain control (acetominophen, NSAID’s, or narcotics), activity as     tolerated, and time. (1, 3-8 ) The general consensus is that fifty percent of patients with     sciatica recover within six weeks, and that ninety percent are better in twelve weeks.(4, 8)     Those patients with intractable pain or progressive neurologic symptoms usually receive     epidural steroid injections and, if necessary, decompressive laminectomy or discectomy. (2,     8, 9)      Low back pain and sciatica result in tremendous losses to our society in terms of decreased     productivity and cost of treatment. (1, 12) Oral steroids are inexpensive and relatively safe     medications that, if effective in reducing the pain and disability associated with sciatica,     could improve the quality of patients’ lives, and result in significant cost savings to     society at large. We hypothesize that the use of oral steroids to treat acute sciatica will     speed patients’ recovery as measured by: changes in physical findings, rates of return to     work and activities of daily living, pain and disability assessment scores, and decreases in     the use of narcotic and non-steroidal anti-inflammatory drugs (NSAID’s), and in the need for     epidural injection or surgical intervention.   "
189342|NCT00317460|"     The purpose of this study is to examine the efficacy of providing two levels of psychosocial     support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients     receiving their care in an HIV clinical care setting.   "
189343|NCT00317473|"     To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed     children living in western Kenya and aged 12-47 months   "
189344|NCT00317486|"     This study evaluates the effects of bosentan on oxygen saturation, hemodynamics and exercise     capacity in patients with pulmonary arterial hypertension related to Eisenmenger physiology.     Patients receive bosentan or placebo for 16 weeks.   "
189345|NCT00317499|"     This was a phase 3, double-blind, placebo-controlled, randomized, multicenter study in     subjects with psoriatic arthritis (PsA) and psoriasis comprising 3 periods: a 24-week     double-blind period, a ≤ 24-week maintenance period, and a 48-week open-label period. During     the double-blind period, subjects were randomized equally to 1 of 2 regimens: etanercept 25     mg twice weekly (BIW) or placebo, administered subcutaneously (SC). After the week 24 visit,     subjects continued on blind-labeled therapy in a maintenance period until all subjects     completed the double-blind period. After the maintenance period, all subjects received     open-label etanercept 25 mg BIW.   "
189346|NCT00317512|"     The purpose of this study is to assess the safety and feasibility of a novel oxygen carrying     solution, HBOC-201, in the setting of PCI for Acute Coronary Syndromes from randomization til     hospital discharge.   "
189348|NCT00317538|"     The purpose of this study, in patients with rheumatoid arthritis who have had an incomplete     response to etanercept and methotrexate (MTX), are to evaluate: safety and evidence of     therapeutic benefit of infliximab and methotrexate, the levels (pharmacokinetics) of     etanercept and infliximab and antibodies (immunogenicity) to etanercept and infliximab in     patients blood, whether switching from etanercept to infliximab changes progression of     structural damage over the study period, and whether specific markers in the blood     (pharmacodynamics) correlate with therapeutic response or benefit.   "
189349|NCT00317551|"     We have identified focussing problems related to myopia getting worse. Our trial uses optical     and orthoptic interventions that correct the focussing problems to see if this retards myopia     progression.   "
189350|NCT00317564|"     This is a prospective, observational, registration and follow-up study of women exposed to     Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual     period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine     whether there is an increased risk or a pattern of birth defects in the offspring of women     exposed to Betaseron® at conception and during pregnancy compared to rates from women in the     general US population. Secondarily, the Registry will examine rates of spontaneous abortions     and other negative pregnancy outcomes in this population. This study will be conducted in the     United States (US). The Betaseron® Pregnancy Registry is sponsored by Bayer HealthCare     Pharmaceuticals and is managed by the Post Approval & Strategic Services group at INC     Research, LLC. The scientific conduct and analysis of the Registry will be overseen by an     Independent Data Safety Monitoring Board (IDSMB) consisting of external specialists in     teratology, epidemiology, maternal and fetal medicine, and neurology (external member details     available upon request).   "
189382|NCT00317993|"     The purpose of this study is to investigate the effects of the two lipid -lowering drugs,     ezetimibe and simvastatin, on lipid metabolism in humans. In specific, the study will     investigate in blood cells whether the enzyme that controls cholesterol synthesis, HMG-CoA     reductase, and the receptor that takes up cholesterol from the blood, the LDL receptor, are     changed during treatment with the aforementioned drugs.   "
189481|NCT00312741|"     The hypothesis is that community-acquired pneumonia is usually a monomicrobial infection.     Therefore, early detection of the etiology allows to select the most active, narrow-spectrum,     and cheap, and less toxic antibiotic agent.   "
189351|NCT00317577|"     Low-pressure (normal tension) glaucoma is a type of open-angle glaucoma resulting in damage     to the optic nerve and abnormalities of the visual field. Eye (intraocular) pressure in this     type of glaucoma is not higher than that usually considered to be normal (less than 21 mmHg)     for the eye. The present treatment of low-pressure glaucoma is also directed to lowering the     “normal” eye pressure. Both medications in this study, brimonidine and timolol, lower eye     pressure.      Laboratory research over the past decade indicates the potential to treat glaucoma not only     by lowering eye pressure, but with treatments aimed at the damage occurring at the optic     nerve. One group of drugs, selective alpha2-adrenergic agonists, have been shown in     laboratory animals to protect against the effects of nerve damage following local stroke.     Brimonidine, one of the medications in the current study, is a selective alpha2-adrenergic     agonist which protects against damage to optic nerve in animal models of glaucoma..      The hypothesis of the present study is that brimonidine eye drops provide protection to the     damaged optic nerve independent of lowering eye pressure in patients with low-pressure     glaucoma. This will be determined by (1) measuring eye pressure, (2) performing visual field     examinations, and (3) examination of the optic nerve.   "
189352|NCT00317590|"     There is increasing evidence from African countries, including Burkina Faso, that at least in     some settings/seasons the proportion of fevers attributable to malaria is low or very low:     this means that the current strategy of treating all fever cases as malaria is only to the     advantage of very few. Rapid, antigenic tests might be of help, particularly in peripheral     health centres such as the Centres de Santé et Promotion Sociale (CSPS) that lack any     laboratory facilities. Nevertheless two major problems could arise:        -  False negatives: as only the negative result would change the decision to treat, versus          the current presumptive strategy, false negatives would not be treated for malaria.        -  False positives: they would be exposed to the risk to be left without treatment for the          true cause of their fever instead.      The main purpose of this study is to assess if the short term outcome of febrile patients     treated after testing with the Rapid Diagnostic Test Paracheck® is at least equivalent (not     inferior) to that of controls (presumptively treated without any test) in terms of clearance     of fever and other major symptoms and signs.      To do so, febrile patients will be randomly assigned to be submitted to the test before     clinical decision, or to be managed the usual way with no test. A follow up will be carried     out at Day 4th in order to determine the proportion of patients in both groups with     persistence of fever and other main clinical symptoms.   "
189353|NCT00317603|"     The purpose of this trial is to test the safety of a vaccine made from a patient's own breast     cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The     vaccine is made by genetically modifying a patient's own tumor cells to secrete     granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response.   "
189354|NCT00317616|"     Pre-fALS is a prospective natural history and biomarker study of people not yet affected with     ALS, but who are at genetic risk for developing ALS. The investigators aim to recruit     unaffected (healthy) people from familial ALS (fALS) pedigrees in which a known genetic     mutation associated with ALS has been identified; for this study, a fALS pedigree is one with     two biologically related individuals who have or have had ALS and/or FTD. Individuals who may     be at genetic risk for ALS and who belong to families with at least one affected family     member who has tested positive for a known ALS genetic mutation may also be eligible to     participate. Our goal is to study the pre-symptomatic phase, onset and progression of ALS and     to learn more about genetic and environmental factors that put people at risk for developing     ALS.   "
189364|NCT00317746|"     With the improved prognosis of human immunodeficiency virus (HIV) infection, end stage liver     disease due to hepatitis C (HCV) now represents a major cause of morbidity and mortality in     people with HIV. Treatment for HCV has become increasingly important as a means of preventing     the consequences of chronic HCV infection. Paradoxically, co-infected patients have low rates     of treatment initiation and completion in large part because they have a high risk of     developing neuropsychiatric symptoms while receiving PEG-interferon (PEG-IFN). There are a     large number of co-infected individuals in Canada who could benefit from HCV therapy if     tolerability could be improved. This trial will address whether prophylactic use of     antidepressants in HIV-HCV infected patients initiating HCV therapy can prevent the     development of neuropsychiatric side effects and thus permit more patients to receive full     treatment for HCV.   "
189379|NCT00317954|"     The aim of the study was to evaluate the renoprotective effect (i.e. albuminuria- and     bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic     patients with albuminuria despite recommended antihypertensive treatment.   "
189355|NCT00317629|"     Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an     increasing incidence over the last two decades. So far, pentavalent antimony compounds have     been considered the treatment of choice, with a percentage of cure of about 85%. However, the     high efficacy of these drugs is counteracted by their many disadvantages and adverse events.     Previous studies have shown nitric oxide to be a potential alternative treatment when     administered topically with no serious adverse events. However, due to the unstable nitric     oxide release, the topical donors needed to be applied frequently, making the adherence to     the treatment difficult. The electrospinning technique has allowed the production of a     multilayer transdermal patch that produces a continuous and stable nitric oxide release. The     main objective of this study is to evaluate this novel nitric oxide topical donor for the     treatment of cutaneous leishmaniasis.      A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620     patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether     this patch is as effective as meglumine antimoniate for the treatment of cutaneous     leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous     leishmaniasis will be medically evaluated and laboratory tests and parasitological     confirmation performed. After checking the inclusion/exclusion criteria, the patients will be     randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously     meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo     of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the     medications will be administered daily and the presence of adverse events assessed. During     the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The     healing process of the ulcer, the health of the participants, recidivisms and/or reinfection     will also be assessed. The evolution of the ulcers will be photographically registered. In     the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic     alternative for one of the most important public health problems in many countries will be     available to patients.   "
189384|NCT00318019|"     In this study the food supplement OPC Factor will be tested to determine its effectiveness     for increasing energy levels in healthy people aged 45-65 when compared to a placebo. All     subjects will receive both active product and placebo at some time during the study. The     study is nine weeks in duration. It involves three visits, taking an effervescent powder in     water twice a day, and answering 24 multiple choice questions once a week. Subjects who     complete the study can elect to receive a two month supply of the study product free of     charge.   "
189356|NCT00317642|"     Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the     treatment of pediatric patients 1 to 21 years old with relapsed acute or refractory     lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.      There is no recommended standard treatment for relapsed or refractory acute myelogenous     leukemia in older patients. Cytarabine is the most commonly used drug to treat these     patients. This study will determine if there is benefit by combining clofarabine with     cytarabine. Patients will be randomized to receive up to 3 cycles of treatment with either     placebo in combination with cytarabine or clofarabine in combination with cytarabine.     Randomization was stratified by remission status following the first induction regimen (no     remission [i.e., CR1 = refractory] or remission <6 months vs CR1 = remission ≥6 months). CR1     is defined as remission after first pre-study induction regimen. The safety and tolerability     of clofarabine in combination with cytarabine and cytarabine alone will be monitored     throughout the study.   "
189357|NCT00317655|"     The main purpose of this study is to investigate the ability of some dietary supplement     products to affect general joint health and life quality in a selected population with back     pain.      The study is randomized and double - blind, with parallel groups receiving treatment for a     duration of 12 weeks.   "
189358|NCT00317668|"     The investigators will check the serum of epilepsy patients for antibodies against glutamate     receptors and double stranded DNA. They will characterise the patients (by the kind of     epilepsy, autoimmune disease comorbidity, and cognitive profile).   "
189359|NCT00317681|"     The purpose of this study is to evaluate the efficacy of topical tacrolimus in different     subtypes of cutaneous lupus erythematosus. As shown by several groups activated memory T     lymphocytes play a key role in the pathogenesis of lupus erythematosus. Tacrolimus targets T     lymphocytes and suppresses their activation by inhibiting the expression of cytokine genes,     such as IL-2. Therefore, treatment of cutaneous lupus erythematosus with topical tacrolimus     might result in an improvement of skin lesions in such patients.   "
189360|NCT00317694|"     Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food,     reducing the amount that the body can absorb.      The purpose of this study it to look at how effective and safe Magnesium iron     hydroxycarbonate is in controlling levels of phosphate in the blood in patients who receive     hemodialysis.   "
189361|NCT00317707|"     In the everyday practice cardiovascular prevention in people at high risk is still     unsatisfactory and treatments with documented efficacy are generally under-used.      Polyunsaturated fatty acids of marine origin (n-3 PUFA) are the latest more promising     strategy to improve prognosis in these patients.      The Risk and Prevention study combines an epidemiological and an experimental approach in     order to:        1. Verify the possibility to optimise cardiovascular prevention in subjects at high risk by          planning the intervention with patients and setting individual goals (outcome study)        2. Evaluate the efficacy of a long term n-3 PUFA treatment in reducing the incidence of          cardiovascular events, through a controlled, randomised, double blind clinical trial.   "
189362|NCT00317720|"     Primary Objectives:        1. To identify the optimal dose and pharmacokinetics of RAD001 in combination with          trastuzumab in a Phase I trial        2. To determine the efficacy of RAD001 plus trastuzumab in HER-2-overexpressing patients          with resistance to trastuzumab-based therapy for metastatic breast cancer in a Phase II          trial.             1. Trastuzumab resistance will be defined as the development of progressive disease               after trastuzumab-based therapy for metastatic breast cancer. Patients who develop               metastases while receiving adjuvant or neoadjuvant trastuzumab will be eligible.             2. Efficacy would be measured by the rate of objective response plus stable disease               lasting 6 months (complete response (CR) + partial response (PR) + stable disease               SD).      Secondary objectives:        1. To determine the pharmacokinetics of RAD001 in combination with trastuzumab. In the          phase II portion of the study, pharmacokinetic studies will be optional.        2. To determine the nature and degree of toxicity of RAD001 in combination with trastuzumab          in this cohort of patients        3. To determine expression levels of total and phosphorylated mTOR and p70S6K-T389-P as          well as relevant downstream signaling components (e.g., S6, 4E-BP1) in pre- and post-          treatment tumor samples.        4. To correlate biomarker expression with response to therapy.   "
189363|NCT00317733|"     The purpose of this study is to determine the safety and effectiveness of 110 mg ketoprofen     in Transfersome applied to the skin twice daily as compared to placebo and oral celecoxib 200     mg per day for the relief of signs and symptoms of osteoarthritis of the knee for a period of     six weeks.   "
189365|NCT00317759|"     RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to     stimulate the immune system and stop cancer cells from growing. Fludarabine may help the     immune system kill more cancer cells.      PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular     adoptive immunotherapy in treating patients who have metastatic melanoma.   "
189380|NCT00317967|"     The purpose of this study is to determine if a drug called atorvastatin will reduce the size     and stiffness of the muscle in the left ventricle of the heart.   "
189366|NCT00317772|"     The purposes of this study are:        1. To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD)          weekly of topotecan in combination with standard dose gefitinib in patients with          relapsed, platinum-resistant, ovarian, peritoneal or fallopian tube cancers that are          epidermal growth factor receptor (EGF-R) positive (>/= 1+).        2. To determine the response rate and response duration in this patient population treated          with the maximum tolerated dose (MTD) of topotecan administered on a weekly schedule in          combination with standard dose gefitinib, given by way of the mouth (PO) daily.   "
189383|NCT00318006|"     This study will compare nasal saline irrigation with nasal saline spray for the treatment of     chronic nasal and sinus symptoms. Participants will complete a questionnaire regarding their     nasal and sinus symptoms and will be randomly assigned to one of the treatment groups. Each     participant will be instructed on how to perform daily nasal treatment.The subjects will     complete follow-up surveys at regular intervals to assess any change in their nasal symptoms     after starting nasal saline treatment. Participants may take their usual medications for     sinus symptoms during their participation in the study.   "
189367|NCT00317785|"     RATIONALE: Giving total-body irradiation and chemotherapy, such as cyclophosphamide, before a     donor stem cell transplant helps stop the patient's immune system from rejecting the donor's     stem cells and helps stop the growth of cancer or abnormal cells. When the healthy stem cells     from a donor are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells     from a donor can make an immune response against the body's normal cells. Giving     immunosuppressive therapy before or after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving total-body irradiation together with     cyclophosphamide works in treating patients who are undergoing donor stem cell transplant for     hematologic cancer and other diseases.   "
189368|NCT00317798|"     RATIONALE: Biological therapies, such as antithymocyte globulin may stimulate the immune     system in different ways and stop cancer cells from growing. Sirolimus may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. It may also prevent or     reduce the side effects of antithymocyte globulin. Giving antithymocyte globulin together     with sirolimus may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of antithymocyte     globulin when given together with sirolimus in treating patients with relapsed multiple     myeloma.   "
189369|NCT00317811|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways     to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Ascorbic acid may help melphalan work better by making cancer cells more sensitive     to the drug. Giving bortezomib together with ascorbic acid and melphalan may kill more cancer     cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with ascorbic     acid and melphalan works in treating patients with newly diagnosed multiple myeloma.   "
189370|NCT00317837|"     Insertion of a hemiarthroplasty is a well established treatment for a dislocated medial hip     fracture in elderly patients. The purpose of this study is to compare unipolar and bipolar     hemiarthroplasty as a treatment for patients aged 70 years or above with a dislocated medial     femoral neck fracture. The study is prospective and randomised, and will be based on     questionnaires, clinical examinations, registration of complications and radiographic     evaluation at follow up at 3 months, 1 and 3 years postoperatively.   "
189371|NCT00317850|"     The specific aim of the Gabapentin for the Relief of Idiopathic Subjective Tinnitus Trial is     to assess the therapeutic benefit of Gabapentin (Neurontin®) for subjective idiopathic     troublesome tinnitus. We employed a double-blind placebo-controlled randomized clinical trial     design to assess the efficacy of Gabapentin. Adults, between the ages of 18 and 70 with     idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6     month's duration or greater and score of 38 or greater on the Tinnitus Handicap Inventory     were enrolled.   "
189372|NCT00317863|"     Zink and bone strength   "
189373|NCT00317876|"     RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone     marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune     system from rejecting the donor's bone marrow. The donated bone marrow stem cells may replace     the patient's immune system and help destroy any remaining abnormal cells. Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving cyclosporine and methotrexate before or after transplant may stop this from     happening.      PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide in     treating patients who are undergoing a donor bone marrow transplant for Fanconi's anemia.   "
189374|NCT00317889|"     This is a prospective, randomized study comparing two different bone preparation techniques     for insertion of a porous coated titanium cementless femoral stem. Patients receiving a     bilateral total hip replacement are randomized to conventional broaching on one side and     compaction on the other side.      Hypothesis: Compaction results in significantly less stem migration [evaluated by     radiostereometric analysis (RSA)], less peri-prosthetic bone mineral density (BMD) loss     [evaluated by dual energy x-ray absorptiometry (DEXA)], and a higher Harris hip score after     two years.   "
189375|NCT00317902|"     The objective of this study was to treat anemic (Hemoglobin (Hb) < 12 g/dL) HIV-infected     subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of > 13 g/dL and then to     assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained     with every other week (Q2W) PROCRIT (Epoetin alfa) dosing.   "
189376|NCT00317915|"     The aim of this multicenter, doubleblind, randomized study was to investigate the     renoprotective effect of irbesartan treatment in patients with type 2 diabetes and     microalbuminuria (a precursor of diabetic kidney disease). 590 patients were randomized to a     median 24 months of treatment with 300 mg irbesartan once daily, 150 mg irbesartan once daily     or placebo. Time to development of overt nephropathy, defined by persistent proteinuria, was     the primary outcome measure.   "
189377|NCT00317928|"     Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women     with PCOS. Ovulation is restored and bleeding periods become regular.      Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for     6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6     months. Measurements are performed before ech treatment period, every second month during     treatment and after completing treatment.   "
189378|NCT00317941|"     The purpose of this study is to compare the injection site reaction and injection site pain     after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different     autoinjectors.   "
189555|NCT00330538|"     Hypothesis:      Pediatric patients with acute lymphoblastic leukemia, treated with chronic glucocorticoids as     a part of the leukemia treatment protocol, will have an increased incidence and severity of     osteoporosis.   "
189381|NCT00317980|"     The purpose of this study is to determine whether low-dose pentavalent antimony is equally     effective when compared to the standard-dose regimen in patients with cutaneous     leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.   "
189426|NCT00318578|"     The aim of the study is to evaluate, prospectively, prognosis factors associated with     convulsive status epilepticus (CSE) in adults hospitalized in intensive care units.   "
189385|NCT00318032|"     Diabetes is a common chronic condition associated with the risk of heart disease, and eye and     kidney damage. Many people are diagnosed with diabetes when they develop symptoms or     complications, suggesting that the true onset of disease occurs years earlier. Early     detection of diabetes may result in health benefits, but this is not proven. People of South     Asian origin are at more risk of having diabetes and of getting the heart disease     complications associated with it. The study aims to test whether screening for diabetes is     feasible in a South Asian population and to measure the benefits of early detection and     intensive treatment.      Hypothesis: A program of screening and an intensive multi-factorial intervention for type 2     diabetes is both feasible and cost effective within primary care.   "
189386|NCT00318045|"     The aim of this study is to examine the relationship between optical blur from poor     refractive corrections (glasses) of workers using computers and their productivity and     comfort in the workplace. We believe that improving the visual status of subjects who use     computers will have a beneficial effect on productivity and visual comfort.   "
189387|NCT00318058|"     As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy     adults, probably as a result of immunosenescence, there is a desire to devise ways to     increase the current vaccines efficacy for this target population. Adjuvants are known to     boost immune responses, thus representing one way to increase the efficacy of the current     GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is     to evaluate the immunogenicity and the reactogenicity of a revaccination with the adjuvanted     GlaxoSmithKline influenza vaccine administered intramuscularly about 1 year after     administration of the first dose of vaccine. For immunogenicity and safety evaluations,     subjects who have already received Fluarix™ during the preceeding year will receive a dose of     commercial vaccine and will form the control group of this trial.   "
189388|NCT00318071|"     The primary objectives of the Multi MERCI trial were:        -  to evaluate the addition of the Merci L5 Retriever        -  additionally permit use of the Merci Retrieval System in the setting of persistent clot          following IV t-PA treatment (use in the 0-8 hour window for patients ineligible for IV          t-PA was also permitted)   "
189389|NCT00318084|"     The purpose of this study is to determine the diagnostic value of two week treatment with     Nexium as a confirmatory test for patients with suspected reflux disease.   "
189390|NCT00318097|"     McCune-Albright syndrome (MAS) is a syndrome caused by a genetic mutation that causes a     specific protein in the body called a G protein to be constantly active. Children with     McCune-Albright syndrome classically have early puberty, areas of increased skin     pigmentation, and bone lesions resulting from the constant activity of the specific protein     involved.      Histamines are known to play a role in allergies and related allergic problems. The effects     of histamines are controlled by the same G protein that is overly active in McCune-Albright     syndrome. Thus, one could predict that patients with McCune-Albright may be at high risk for     allergic problems. To date, no studies have documented any form of histamine excess or     allergic difficulties in patients with McCune-Albright syndrome. However, the investigators     have made the observation that a high percentage of their patients with MAS exhibit a range     of allergic symptoms, from mild symptoms, to severe, life-threatening symptoms.      The purpose of this study is to demonstrate increased histamine response by using a histamine     skin test in patients with MAS. If increased reactions to histamines can be documented in MAS     patients when compared to controls, severe and potentially life threatening allergic     reactions in children with MAS could be anticipated and avoided.   "
189391|NCT00318110|"     The purpose of this study is to find out what effects (good and bad) a stem cell transplant     from an unrelated donor will have for patients with kidney cancer that has spread to other     parts of the body (metastasized).   "
189392|NCT00318123|"     To evaluate the therapeutic equivalence between the two arms of treatment in virological and     immunological response after 48 weeks and to evaluate the presence of side effects during the     follow-up period.   "
189393|NCT00318136|"     This is an open-label, single-arm, multicenter pilot study to evaluate the safety and     efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb     with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell     Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.   "
189407|NCT00318318|"     The purpose of this study is to assess the immunological status of patients using Premarin.     Premarin use is associated with an enhanced immune status, and possibly even some anti-cancer     effect. The researchers will compare the use of Premarin with those not using hormone     replacement therapy (HRT) to track the effects of Premarin in reducing the risk of infection     and swelling.   "
189394|NCT00318149|"     As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy     adults, probably as a result of immunosenescence, there is a desire to devise ways to     increase the current vaccines efficacy for this target population. Adjuvants are known to     boost immune responses, thus representing one way to increase the efficacy of the current     GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is     to evaluate the immunogenicity and the reactogenicity of a vaccination with four different     adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For     immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly     aged 65 years and older will receive Fluarix™ and form the control groups of this trial.   "
189395|NCT00318162|"     This study will examine the effects of low-dose naltrexone (LDN) on children with autistic     spectrum disorders. The investigators hope to show a positive effect on social functioning     and language.   "
189396|NCT00318175|"     Endothelin-1 is a potent vasoconstrictor and binds to two receptors, ET-A and ET-B, which are     variable expressed on endothelial cells, smooth muscle cells, and fibroblasts. Furthermore,     endothelin-1 has been found to be released in vitro by scleroderma fibroblasts and could     contribute to the development of dermal fibrosis in systemic sclerosis. Bosentan is a dual     receptor antagonist, that competes with the binding of endothelin-1 to both receptors and has     already been approved for the treatment of pulmonary arterial hypertension in Europe, the US,     and some other countries. The purpose of this study is to evaluate the effect of bosentan     treatment on skin fibrosis and functionality in patients with systemic sclerosis.   "
189397|NCT00318188|"     Systemic sclerosis (SSc) is a connective-tissue disease characterized by excessive collagen     deposition, vascular hyper-reactivity and obliterative microvascular phenomena leading to     disability, handicap, and worsening of quality of life. Pharmacological treatments are mainly     used for vascular involvement. To date, no pharmacological treatment have been shown to be     effective for the fibrosis leading to skin, tendon, and joint disability. Our hypothesis is     that rehabilitation could be an interesting non pharmacological treatment in order to     decrease the handicap of SSc patients. Our objective is to evaluate the effect of a     personalized standardized rehabilitation program on the quality of life of SSc patients in a     multicentric randomized controlled trial. This trial will compare a personalized standardized     rehabilitation program to the usual non pharmacological treatment. The primary outcome     measure will be the HAQ DI (Health Assessment Questionnaire Disability Index). A Zelen design     will be used for this study.   "
189398|NCT00318201|"     We, the researchers at the Indiana University School of Medicine, are doing this study to     better understand how the effects of certain medications are altered when taken     simultaneously, or in combination with each other. We will also look at how each volunteer's     genes (DNA) may affect the way these medications are metabolized.      Hypothesis:      We will test the hypothesis that the extent of drug-drug interaction caused by the     combination of erythromycin and diltiazem is not predictable from the extent of interaction     produced by each inhibitor alone. Specifically we will test the hypothesis that the     combination of erythromycin and diltiazem will cause a greater decrease in midazolam     intravenous and oral clearance than the sum of the decreases caused by each inhibitor alone.   "
189399|NCT00318214|"     This is a clinical research study of an experimental topical drug for the treatment of     chronic, neuropathic, diabetic foot ulcers. The purpose of the study is to determine the     safety of the experimental drug when applied to large, diabetic foot ulcers. The study will     also determine if the experimental drug can safely promote healing of diabetic foot ulcers     better than standard treatments currently available to doctors.      Patients participating in the study may receive an active drug (MRE0094) or inactive drug     (placebo). What treatment a patient will receive is determined by chance (like drawing a     number from a hat). All patients will receive additional care for diabetic foot ulcers during     the study.      Participation in the study can be up to 4½ months.   "
189400|NCT00318227|"     The purpose of this study is to determine whether a less restrictive strategy of red blood     cell transfusion in elderly patients following coronary bypass surgery results in enhanced     postoperative recovery as determined by quality of life assessment, exercise tolerance and     clinical outcomes.      Two postoperative transfusion strategies:        1. Liberal - transfused when Hgb is <100g/L        2. Restrictive - transfused when Hgb is <70g/L   "
189401|NCT00318240|"     This is a feasibility study to determine safety and the ability of HIFU (High Intensity     Focused Ultrasound)to selectively destroy prostate cancer tissue in men who demonstrate local     recurrence of prostate cancer following radiation treatment.   "
189402|NCT00318253|"     The study is based on the hypothesis that consumption of cranberry juice products results in     the production of metabolites in the urine that have anti-adhesive properties on bacteria. A     crossover study using 12 healthy women will be given different cranberry products or water as     a control and their urine will be analyzed for anti-adhesive effects and compared to the     properties of the urine. Cranberry juice will also be evaluated for its effect on vaginal     microflora.   "
189403|NCT00318266|"     It is hypothesized that the NMP22(Nuclear Matrix Protein) Bladder Check ® Test will     demonstrate improved sensitivity over that of standard urine cytology for patients with     superficial transitional cell carcinoma at high risk of recurrence.   "
189404|NCT00318279|"     To determine if practicing an aorto-saphenous vein anastomosis on a low-fidelity surgical     simulator allows trainees to produce a higher quality anastomosis in a shorter period of     time, than a group that only learns by watching a video.   "
189405|NCT00318292|"     Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a     painful stimulus. This trial is examining the effects of a local anesthetic given at the     point of innervation prior to performing a vaginal hysterectomy with suspension sutures.   "
189406|NCT00318305|"     The purpose of this study is to determine patient preference and acceptance of tablet sodium     phosphate bowel preparation in patients who had polyethylene glycol (PEG) solution for their     prior colonoscopy. This study will provide answers related to the patient preferences and     their acceptance of this new method of bowel preparation.   "
189556|NCT00330551|"     This study will determine the effectiveness of oral risperidone versus long-acting injectable     risperidone in treating people with first-episode schizophrenia.   "
189408|NCT00318331|"     Glutamine is an amino acid which is rapidly depleted in critical illness. It is used as     energy by cells that line the gut, vital for immune system function, and works as an     anti-oxidant. Glutamine supplementation has been shown to improve outcomes in ICU patients.     We hypothesize that critically ill patients given extra glutamine will have less of an     inflammatory response and therefore better outcomes than patients not given extra glutamine.     Our study randomizes patients to tube feeding with OR without extra glutamine to see if it     affects patient outcomes as well as markers of inflammation.   "
189409|NCT00318344|"     For thousands of years people in the South Pacific have used Atuna racemosa extract as a     topical anti-inflammatory. We, the researchers at the Mayo Clinic, have shown this extract to     also have antibacterial properties. While this extract has been used for decades in the South     Pacific, a controlled clinical trial to evaluate toxicity has never been performed.   "
189410|NCT00318357|"     The CARE-HF long-term follow-up trial evaluates the effects of cardiac resynchronization (CR)     therapy on the mortality of patients from the CARE-HF program for an additional 4 year     follow-up. Investigators are free to choose whatever available treatment they believe is in     the patient's best interest.   "
189411|NCT00318370|"     The purpose of this study is to determine if an investigational drug called MORAb-003 is     useful by itself or when used with other approved cancer drugs in treating women with ovarian     cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian     cancers.   "
190171|NCT00334659|"     The purpose of this study is to confirm that apricitabine does not induce any clinically     significant effect upon electrocardiogram (ECG) parameters at doses consistent with the     maximum exposure expected to occur in clinical practice.   "
189412|NCT00318383|"     The purpose of this study is to determine whether vaccination with NicVAX will result in a     higher continuous abstinence rate than vaccination with placebo in smokers who want to quit     smoking. In addition, two different formulations and dosing schedules will be studied, to     select the dose and dosing schedule which generates the highest level of anti-nicotine     antibodies. The primary study period is 12 months, which was extended by amendment to include     up to 2 years of observations.   "
189413|NCT00318396|"     This is a prospective, randomized study comparing two different bone preparation techniques     for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who     receive a unilateral total hip replacement are randomized to either conventional broaching or     compaction.      Hypothesis: Compaction results in significantly less stem migration [evaluated by     radiostereometric analysis (RSA)], less peri-prosthetic bone mineral density (BMD) loss     [evaluated by dual energy x-ray absorptiometry (DEXA)], and a higher Harris hip score after     two years.   "
189414|NCT00318409|"     Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual     behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or     acquiring HIV. No studies have tested the feasibility and acceptability of conducting     pharmacologic interventions to reduce meth use and meth-associated sexual risk behavior among     MSM. The purpose of this pilot study is to determine the feasibility enrolling and retaining     meth-dependent MSM into a pharmacologic study of bupropion vs. placebo and measuring the     tolerability of and adherence to medication among these participants.   "
189415|NCT00318422|"     This trial is conducted globally (the United States of America excepted). This trial is     designed to show the effect of treatment with liraglutide when added to existing glimepiride     therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on     therapy to glimepiride.   "
189416|NCT00318435|"     The type of hemodialysis access and preservation of this access greatly influences the     quality of life and survival of patients undergoing hemodialysis. The Kidney Disease Outcomes     Quality Initiative (K/DOQI) guidelines for vascular access recommend the primary placement of     native or autogenous hemodialysis fistulas in preference to polytetrafluoroethylene (PTFE)     grafts and central venous catheters because the former form of access has fewer complications     and a longer durability. However, autogenous hemodialysis fistulas, like     polytetrafluoroethylene grafts, are also subject to dysfunction and eventual failure.     Endovascular angioplasty has become an accepted alternative treatment to surgical revision     for hemodialysis access-related venous stenoses and occlusions. However, the patency rates in     the follow-up period are low because of the high frequency of restenosis due to intimal     hyperplasia. Since 1988, noncovered stents have been used to improve fistula patency. In the     central veins, bare stents demonstrate better patency rates than percutaneous transluminal     angioplasty (PTA) alone. Neointimal hyperplasia is the major reason for restenosis following     stent placement. The cephalic vein forms the outflow conduit for radiocephalic and     brachiocephalic autogenous fistulas. It has recently been suggested that a focal area of the     cephalic vein is prone to developing hemodynamically significant stenosis, in what is now     termed the cephalic arch. This is the perpendicular portion of the cephalic vein in the     region of the deltopectoral groove before its junction with the axillary vein. To overcome     the problem of restenosis due to intimal hyperplasia in the cephalic arch the investigators     used the insertion of a stent-graft as an alternative approach. In this study they     investigated the use of a PTFE-covered nitinol stent-graft (Fluency, Bard) versus a Luminex     (Bard) stent.   "
189417|NCT00318448|"     There has been an increased interest in the association between ADHD and sleep disorders over     the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been     identified in ADHD children regardless of whether or not they are receiving stimulant     therapy. This study will assess the safety and efficacy of zolpidem in children with ADHD     associated insomnia.   "
189418|NCT00318461|"     This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is     designed to show the effect of treatment with liraglutide when adding to existing metformin     therapy and to compare it with the effects of metformin monotherapy and combination therapy     of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised,     double-blinded period followed by an 18 months open-label extension, in total 2 years (104     weeks).   "
189419|NCT00318474|"     IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of     individuals diagnosed with IgAN, including children, will eventually progress to chronic     renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the     safety and benefits of MMF in patients with IgAN who have been pre-treated (and continue to     be treated) with angiotensin converting enzyme inhibitors (ACEi) and fish oil supplements     (FOS).   "
189420|NCT00318487|"     Fifteen (15) patients completely edentulous in the maxilla will be treated with 8 dental     implants. The total treatment will be done in 2 stages to allow, within the same group, a     study of two different approaches. Miniscrews that can be functionally loaded will be     provided by 3i with the design and surface textures as wanted by the study sponsor.   "
189421|NCT00318500|"     The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75     mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms     (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.   "
194678|NCT00393419|"     The purpose of this study is to determine the effect of a comprehensive pharmacy care program     on medication adherence and persistence, blood pressure, and LDL cholesterol.   "
189422|NCT00318513|"     The purpose of this study is to determine the safety and side effects of bevacizumab in     subjects with lymphedema who will initially receive bevacizumab alone and then in combination     with standard manual lymphatic drainage (MLD) and combined decongestive therapy (CDT). This     study will help to determine the dose of bevacizumab to be used in future studies of subjects     with lymphedema.   "
189423|NCT00318539|"     Quetiapine (Seroquel ®), an atypical antipsychotic registered for use in schizophrenia, which     has a very low propensity of extrapyramidal and endocrine side-effects, has also been studied     as an adjunct in OCD. In an open trial, ten patients with OCD who had not responded to at     least three previous treatments with a SRI at maximum dose and duration were assigned to     receive quetiapine in addition to a SRI for 8 weeks. Given the efficacy of quetiapine in     treatment resistant patients, and given its rapid onset of action (4-6 weeks), it is     postulated that the combination of a low dose atypical antipsychotic and a standard dosage of     an SRI as a treatment for patients with OCD might increase the number of responders as well     as the effect size.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
189425|NCT00318565|"     The primary objective is to provide additional corroborative safety and efficacy data for the     Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).   "
189429|NCT00318617|"     The purpose of this study is to determine the effect of a 4-week treatment period with     GW501516X on how the heart obtains and uses energy. The energy of the heart will be measured     by Magnetic Resonance Imaging (MRI). This study will also measure a number of other potential     markers of drug activity, including levels of certain lipids (fats) and proteins in your     blood. The data from this study may help researchers better understand the actions of this     drug in the body and if this drug may be useful to treat patients with heart disease.   "
189430|NCT00318630|"     This study is to investigate the effects of AVANDIA on the asthmatic response.   "
189431|NCT00318643|"     The purpose of this study is to explore other treatments for patients with superficial     bladder cancer. The investigational medication to be studied is an enzyme called     hyaluronidase, and it is a human recombinant form of the enzyme. An investigational     medication is a medication or formulation of a medication that is not approved by the United     States Food and Drug Administration for use in this country but it may be used in studies     such as this one. The drug company name for this medication is Chemophase. Chemophase will be     given in combination with mitomycin C. Mitomycin C will be given alone one time and then both     drugs will be given together weekly for 5 weeks. Mitomycin C is an anti-tumor drug that is     commonly used to treat superficial bladder cancer. Treatments are administered directly into     the bladder. It is envisioned that Chemophase with mitomycin C may potentially increase the     local penetration of mitomycin C into remaining cancer cells following surgery to treat     superficial bladder cancer.   "
189432|NCT00318656|"     A better glycemic control is associated with less complications (cardiac diseases, blindness,     etcetera) for type 2 diabetic patients. The objective is to study if rosiglitazone may lead     to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than     with a sulphonylurea (glimepiride).   "
189433|NCT00318669|"     This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD).   "
189434|NCT00318682|"     A new approach to the evaluation of liver fibrosis has been proposed using PULSOMETRY. The     objective is to evaluate the diagnostic performances of the FIBROSCAN technique, together     with non-invasive techniques, and to determine how it is able to predict the histological     fibrosis score, defined by the METAVIR score. This transversal study aims to compare the     evaluation of hepatic fibrosis obtained by FIBROSCAN and histology (METAVIR score) in 2550     consecutive patients taken in charge for a liver biopsy. The results of the study will     compare the respective performances of these techniques in the prediction of the METAVIR     score, and help in the recommendation of the care of patients with viral hepatitis B and C;     these methods will undergo a medico-economic study.   "
189435|NCT00318695|"     This will be a double-blind, randomized placebo-controlled study. 253 children were recruited     and randomly assigned into one of 2 groups to receive either normal infant formula or formula     with Bifidobacterium longum and Lactobacillus rhamnosus GG. The primary aim is to assess the     effect of early administration (from birth) of probiotics on the incidence of allergic     sensitization, eczema, asthma and rhinitis.   "
189436|NCT00318708|"     Asthma can be caused by a variety of factors, including tobacco smoke, allergens, and     respiratory airway infections. Many people use inhaled corticosteroid medications to treat     their symptoms. These medications, however, are not effective for everyone. Clarithromycin is     an antibiotic that may effectively treat asthma in these individuals. This study will     evaluate the effectiveness of clarithromycin at controlling asthma symptoms.   "
189449|NCT00312325|"     Because of their antiinflamatory effects, glucocorticoids are often used to reduce edema in     neurologic tissue and to otherwise mitigate the consequences of neural inflammation. For     example, high dose prednisolone treatment has been shown to be an effective therapy for     different eye diseases including severe Graves´ Ophthalmopathy and acute optic neuritis.     However, contradictory results exists for the influence of high dose prednisolone therapy per     se on tissue blood flow. Thus, in the current study, we plan to investigate the effect of     high dose, short time therapy with intravenous prednisolone in patients with optic neuritis     and severe Graves´ Ophthalmopathy.   "
189450|NCT00312338|"     Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora   "
189437|NCT00318721|"     A cluster-randomized vector control trial in Bihar, India, and neighboring Nepal, will test     the efficacy of long-lasting impregnated bednets (LLINs, Permanets) for reducing visceral     leishmaniasis incidence. The intervention unit is the village (400-1000 people). The study is     designed to detect a 50% reduction in Leishmania donovani incidence in intervention compared     to control clusters over 2 years. 24 clusters (selected as high incidence during previous     years) will be randomly allocated to intervention or control. Following health education, and     with informed consent, all households in intervention villages will receive free Permanets     (from September 2006). Net usage will be monitored and new nets provided if required. Control     villages will not be given untreated nets, as - although commonly used in this region - their     effectiveness against sandflies has not been proven. Pre-intervention infection status of     villagers (>2 yrs) will be evaluated serologically from finger-prick blood (and past/current     disease status noted). Incident infections will be recorded by 3-monthly active search for     clinical cases, and by annual serological diagnoses to detect subclinical infections. All     villagers (>2yrs) will be leishmanin skin tested at the end of the trial for further     subclinical infection detection, and sera from a sub-sample will be tested for antibodies to     sandfly saliva antigens (a measure of sandfly exposure). All clinical cases will be given     free treatment. Free Permanets will be provided to control villages after the trial.     Complementary studies involve entomological surveillance by light traps in a sample of houses     and social/economic questionnaire surveys. The entomological surveys will test whether     community-wide use of LLINs provides any mass effect, which could protect those in the     community who fail to use LLIN for any reason.   "
189438|NCT00318734|"     Cardiovascular disease (CVD) affects millions of people in the United States; each year, more     people die from CVD than from any other disease. There are many dietary and lifestyle factors     that may increase the risk of developing CVD. Preliminary research has shown that the     presence of certain trace elements may be associated with the development of CVD. This study     will examine toenail clippings and laboratory data to evaluate the link between trace     elements and CVD risk factors in young adults.   "
189439|NCT00318747|"     This study will test the effectiveness of an investigational treatment for patients with     ragweed-induced asthma, sometimes called fall seasonal asthma. The treatment being tested is     a series of anti-ragweed shots. The purpose of the study is to determine whether a short     series of injections with Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC)     can cause a long-lasting reduction in the symptoms of asthma that are caused by fall hay     fever allergies.   "
190661|NCT00333918|"     The primary objective of this study is to investigate the efficacy and safety of bromfenac     ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo     cataract extraction and intraocular lens implantation.   "
189440|NCT00318760|"     Background:      - Research has shown that clonidine, a drug originally prescribed to treat high blood     pressure and some symptoms of opioid withdrawal, can help block stress-induced relapse to     heroin and cocaine seeking in rats. However, it does not seem to block cue-induced relapse in     rats. Researchers are interested in studying whether clonidine shows the same pattern of     effects on stress- and cue-induced cravings for heroin or cocaine in humans.      Objectives:      - To compare the ability of clonidine to reduce stress- and cue-induced cocaine and heroin     craving in drug abusers.      Eligibility:      - Individuals between 18 and 55 years of age who are current cocaine or heroin users.      Design:        -  This study will consist of two visits: a screening visit to determine eligibility and an          experimental/script session.        -  Before the script session, participants will provide urine and breath samples for          testing. Participants will complete questionnaires to measure their current drug craving          and days since last use of cocaine or heroin.        -  At the start of the script session, participants will receive a dose of clonidine or          placebo as directed by the study researchers. Three hours after dosing, participants          will be read four scripts (two neutral, one stress-inducing, and one drug-cue-related)          with breaks in between each script. After each script, participants will respond to          questions about levels of stress and craving.        -  Participants will provide saliva samples immediately before and during the script          readings, and will also be measured for skin response to the scripts.   "
189441|NCT00318773|"     Serotonergic antidepressants are clearly effective for premenstrual syndrome (PMS). This     study compares short-term treatment (4 months) and long-term treatment (12 months) with     sertraline to determine how long medication should be continued after achieving a good     response, how soon symptoms return after stopping medication, and whether symptoms are     further improved with long-term treatment. Multiple hypotheses include the following: The     percent of relapsed subjects is greater with short-term treatment; relapse is swifter with     short-term treatment; relapsed subjects improve swiftly when returned to medication; patient     satisfactions and quality of life are more improved with long-term treatment.   "
189442|NCT00312234|"     This study is comparing two different exercise programs, Qi Gong (gentle stretching, and     breathing) with an aerobics program (boxing and dancing) to see if children with chronic pain     or fibromyalgia are able to take part in the program. We would also like to know if it is     easy to take part in an exercise program.      We hypothesize that children with chronic musculoskeletal pain and FM, who engage in Qigong     fitness training, will be more compliant, and have an equivalent or possibly superior     improvement on measures of motor function (peak power, endurance, and metabolic efficiency)     compared to children given an aerobic fitness exercise program.   "
189443|NCT00312247|"     The purpose of this research study is to understand the walking patterns, strength and     function changes of boys with Duchenne muscular dystrophy on/off corticosteroids to determine     the best timing and treatment options to maintain walking for as long as possible.   "
189444|NCT00312260|"     The objective of the study is to compare the efficacy of gabapentin and amitriptyline for     treating neuropathic pain in children in a randomized controlled trial.   "
189445|NCT00312273|"     The purpose of this study is to evaluate the effect of aminophylline in patients with     out-of-hospital bradyasystolic cardiac arrest.   "
189446|NCT00312286|"     The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations     and dosing regimens on high-risk cervical human papillomavirus infection in women.   "
189447|NCT00312299|"     First object is to compare square edge PMMA with round edge PMMA IOL where the materials are     same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials     are different   "
189448|NCT00312312|"     The purpose of this study is to evaluate the immunomodulatory effect of treatment of allergic     rhinitis symptoms with specific immunotherapy by measurement of pulmonary inflammatory     markers, and among others, exhaled nitric oxide.   "
189451|NCT00312351|"     The purpose of this trial is to compare the ability of three different doses of pegaptanib     sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing     or improving vision in patients with wet AMD. The study will also examine the effects of     pegaptanib sodium on the cornea and sensory retina of patients with wet AMD.   "
189452|NCT00312364|"     This is a clinical research study of an experimental topical drug for the treatment of     chronic, neuropathic, diabetic foot ulcers.      Patients participating in the study may receive an active drug (MRE0094), inactive drug     (placebo), or a gel used to treat diabetic foot ulcers currently available for sale in the     United States. What treatment a patient will receive is determined by chance (like drawing a     number from a hat). All patients will receive additional care for diabetic foot ulcers during     the study.      Participation in the study can be up to 4½ months.   "
189453|NCT00312377|"     This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in     treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets     the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor     receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial     growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in     lung cancer patients who have had their cancer re-appear after treatment with standard     chemotherapy.      This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can     deliver longer improved progression free survival and improved overall survival than     docetaxel (Taxotere) alone.      All patients participating this clinical study will receive treatment with docetaxel, a     commonly used treatment for recurrent non-small cell lung cancer.      In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF     agent.      Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR)     inhibition, when used with standard chemotherapy, can lead to increased survival in advanced     non-small cell lung cancer (NSCLC) patients.      Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib     (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour     cells and stopping them from dividing.   "
189505|NCT00313053|"     This is a phase I trial in patients with relapsed or refractory leukemia of a human     monoclonal antibody that kills B cell acute lymphoblastic leukemia. The trial will study the     safety, pharmacokinetics, and anti-tumor activity of the antibody given as a single agent and     with vincristine.   "
189454|NCT00312390|"     The visual disorder of amblyopia affects 2% to 3% of the population. Amblyopia is a     developmental condition that is characterized by reduced vision of the eye due to the     presence of a sensory impediment during visual development, such as strabismus (ocular     misalignment) or anisometropia (unequal refractive error), occurring early in life. Recent     studies in humans and animals point towards a cortical locus for the processing deficit in     amblyopia, revealing sensory deficits at the signal cell level that include reduced spatial     resolution, reduced contrast sensitivity, and a reduced number of binocular neural cells. In     the retina, however, no abnormalities have yet been reported.      Like in the brain blood flow in the retina is coupled to neuronal activity. This phenomenon     has been measured by different study groups with non invasive techniques in the brain and     retina. We therefore use a Zeiss fundus camera for the assessment of retinal vessel     diameters. This so called retinal vessel analyzer (RVA) is a combination of a fundus camera     connected to a high resolution video camera equipped with a software based analyzing system.     An unprecedented reproducibility and sensitivity of retinal vessel diameter measurements is     attained with this system. In addition this system allows real time analysis of retinal     vessels as well as off-line determinations from video tape. A special provocation test, which     minimizes risk and discomfort to the subject under study is applied through the illumination     pathway of the fundus camera: Diffuse luminance flicker is used as a stimulus to augment     intrinsic mechanisms by which the retina can vary the vascular supply, in correspondence with     local variations of functional activity. This system allows to study the flicker response of     retinal vessels, which is within a magnitude of 6 to 8%.      However, the exact mechanisms underlying this phenomenon are not fully understood. Especially     in the eye it is not clear whether it is an exclusive metabolic effect within the retina and     the surrounding blood vessels or dependent of central regulatory brain functions.      The purpose of the current study is to improve our understanding of the mechanisms underlying     flicker evoked responses of retinal blood vessels in humans. It is not clear whether the     retina of amblyopic eyes can regulate retinal blood flow in response to increased metabolic     demands as induced during flicking light stimulation. A detail understanding of the metabolic     and functional processes within the retina of patients with amblyopia is a prerequisite for     further research to prevent amblyopia.   "
189455|NCT00312403|"     Matrix metalloproteinases (MMPs) fulfill diverse important molecular functions and play     pivotal roles in development, tissue morphogenesis, repair, aging, and inflammatory     processes. MMPs are also important disease modulating factors, such as cancer, cardiovascular     disease, rheumatoid arthritis or macular degeneration. Functional genetic variants have been     described to fine-tune MMP activities at the gene transcriptional level and have been     associated with increased genetic risk of e.g. arteriosclerosis or cancer. MMPs are also     assumed to play a major role in the remodeling of the extracellular matrix (ECM) in the optic     nerve head during glaucomatous optic neuropathy. MMP-1, MMP-3 and MMP-9 have been shown to be     up-regulated in a variety of animal models of glaucoma. Here, we study three promoter SNPs     within the genes encoding three members of the MMP family. By assessing the prevalence of     genetic variants associated with either increased/decreased enzyme activity, we will (i)     estimate their contribution to the genetic risk of developing primary open angle glaucoma     (POAG) and (ii) investigate the potential role of MMPs in the functional pathology of POAG.   "
189456|NCT00312416|"     Brimonidine tartrate is an alpha-2 agonist ocular hypotensive drug that exerts its effect by     causing both a decrease in aqueous production and an increase in uveoscleral outflow. It has     been proven to reduce increased intraocular pressure in glaucoma and ocular hypertension. As     an alpha 2 agonist Brimonidine belongs to the same class of drugs as Clonidine; however, its     molecular structure is sufficiently different to make it more selective for the alpha 2     receptor than Clonidine. Unlike Clonidine, Brimonidine does not appear to have an effect on     the central nervous system and therefore does not cause sedation or systemic hypotension.      In addition to their known effect of lowering intraocular pressure, alpha 2 adrenoceptor     agonists are neuroprotective. It has, however, been shown that Brimonidine is a very potent     vasoconstrictor in the ciliary body thus reducing aqueous humor production. Little is,     however, known about potential vasoconstrictor effects of Brimonidine in the posterior pole     of the eye. This is of clinical importance, because optic nerve head ischemia appears to     contribute to glaucoma pathophysiology.      This study is performed to investigate the effects of topical Clonidine vs. topical     Brimonidine on choroidal blood flow and intraocular pressure during isometric exercise.   "
189457|NCT00312429|"     Umbilical cord blood is an important source of stem cells and can be used to treat blood and     immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord     blood have been shown to be effective in treating illness in children, but more research is     needed to confirm the benefit of this procedure in adults. The purpose of this study is to     examine the immune system response to cord blood stem cell transplantation in adults with     advanced blood disorders or cancer.   "
189458|NCT00312442|"     The aim of this clinical trial is to evaluate the efficacy and safety of the WST09-mediated     vascular-targeted photodynamic therapy (VTP) in patients with localized prostate cancer     recurrent after external radiation therapy or temporary (High Dose Rate, or HDR)     brachytherapy.   "
189537|NCT00330200|"     The aim of this study is to examine the effects of ISIS 113715 monotherapy on insulin     sensitivity, glucose and lipid metabolism and energy expenditure in subjects with type 2     diabetes mellitus.   "
189459|NCT00312455|"     Many substance dependent individuals continue to abuse a variety of substances during     treatment for their disorder. Often, substance dependent individuals are co-diagnosed with     depression and violence problems. Supplements of n-3 polyunsaturated fatty acids (PUFAs) may     play a role in treating individuals with such substance abuse problems. The purpose of this     study is to evaluate the effectiveness of the n-3 PUFAs eicosapentaenoic acid (EPA) and     docosapentaenoic acid (DPA) in treating relapse, aggression, and depression in substance     dependent individuals.   "
189460|NCT00312468|"     Recent studies have shown that HIV infected individuals have an increased risk of developing     heart disease, but the reason for this is not fully understood. This study will examine     ultrasound test results of blood vessels and laboratory data of HIV infected and HIV     uninfected women to examine the link between heart disease and HIV infection.   "
189461|NCT00312481|"     This will be a randomised, single-centre, single-blind, parallel-group, pilot study in     patients undergoing colonoscopy.      The primary objective is to evaluate the efficacy of MOVIPREP® versus PICOLAX® for gut     cleansing prior to colonoscopy.      The secondary objectives are to evaluate the safety, tolerability and acceptability of     MOVIPREP versus PICOLAX for gut cleansing prior to colonoscopy.   "
189462|NCT00312494|"     3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex     in acutely manic subjects   "
189463|NCT00312507|"     The objective of this pilot study is to examine the feasibility and safety of performing a     larger trial to assess outcomes following treatment of meconium aspiration syndrome with     surfactant lavage compared to bolus surfactant. Specifically, we will determine if surfactant     lavage results in a more rapid improvement in physiologic outcomes (e.g. pulmonary     compliance), as well as clinical outcomes (e.g. length of time on mechanical ventilation).   "
189465|NCT00312533|"     The goal of viscosupplementation is to replenish synovial fluid, which will improve patient     symptoms and mobility. Viscosupplementation of the knee with hyaluronic acid injections has     been shown to improve symptoms in patients with osteoarthritis. Recent studies have shown     that this improvement may be highly variable based on the time from treatment, especially in     the first 12 weeks following treatment. The purpose of this study is to document the outcomes     following a treatment protocol in which corticosteroid is used in addition to the initial     Synvisc injection in the series of three injections.   "
189466|NCT00312546|"     A histone deacetylase (HDAC) inhibitor is a class of drug that interferes with the function     of HDAC, an enzyme that hides HIV within inactive CD4 cells. These drugs are normally used to     treat seizures and other nervous system problems but have been found to work against HIV. The     purpose of this study is to investigate the efficacy of valproic acid (VPA), an HDAC     inhibitor, in treating HIV infected adults using anti-HIV drugs.   "
189467|NCT00312559|"     To determine if yoga is beneficial in improving physical function quality of life and medical     status in people with Parkinson's disease   "
189468|NCT00312572|"     The objective of this study is to evaluate the safety and efficacy of dose conversion from     hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in     subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention     duration is 2 weeks during which time supplemental analgesic medication will be allowed.   "
189469|NCT00312585|"     The purpose of this study is to assess if acupuncture can shorten the time to delivery for     women who are experiencing their first, full-term pregnancy.   "
189470|NCT00312598|"     Weight gain is a serious, common side effect of many antipsychotic medications. On average,     the highest amounts of weight gain are found to occur in people taking clozaril and     olanzapine, but with significant weight gain occuring in those on the other atypical     antipsychotics as well.      We, the researchers at the University of North Carolina, propose an open-label observational,     pilot study of the changes in weight, BMI, body composition, and lipids, glucose, insulin and     other metabolic parameters occurring in subjects as they switch from treatment with     olanzapine, risperidone or quetiapine to aripiprazole. This medication switch will be     determined prior to their entering this study by their treating psychiatrist. We also will     determine resting energy expenditure (REE) and respiratory quotient (RQ) as measured by     metabolic cart to determine if either energy expenditure or the propensity to store energy as     fat may be involved in any changes to weight that are detected. Food intake, hunger, and     physical activity will also be assessed.   "
189471|NCT00312611|"     The purpose of this study is to evaluate efficacy and safety of the Transneuronix IGS System     in a population of patients with a BMI between 35 and 55.   "
189472|NCT00312624|"     This is a pilot study to find a correlation between MRI and ICD therapy in patients with     known cardiomyopathies, aiming to determine if cardiac scarring identified by MRI correlates     with ventricular arrhythmias and the occurrence of ICD therapy.   "
189473|NCT00312637|"     The purpose of this study is to evaluate whether high-resolution magnetic resonance imaging     of the axilla with spectroscopy can identify nodal features suggestive of metastatic     involvement in patients diagnosed with invasive breast cancer. This may enable us to define a     select group of patients for whom axillary lymph node dissection could be avoided.   "
189474|NCT00312650|"     Standard treatment for recurrent ovarian cancer is chemotherapy with one or more drugs. One     of these drugs, Doxil, can cause skin toxicity at the standard dosages. This study     investigates using a lower dose given more frequently in combination with a second drug     Gemcitabine.   "
189475|NCT00312663|"     Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of     America.   "
189476|NCT00312676|"     The hypothesis is that the characteristics of extended release Depakote will allow overnight     conversion of immediate release to extended release form of Depakote. This has been tested     successfully in younger patients but not in individuals over the age of 60. We will include     individuals between 60 and 80 years old.   "
189538|NCT00330213|"     Red wine consumption is associated with reduced cardiovascular disease mortality, and the     cardioprotective properties may be partly related to its ability to improve endothelial     function. The purpose of this study was to determine whether moderate doses of red wine,     de-alcoholized red wine and cognac improve coronary flow reserve.   "
189477|NCT00312689|"     Children with congenital lacrimal stenosis are treated by probing and intubation of the     lacrimal drainage system.      Hypothesis: Microbiological findings at the time of insertion and removal of the silicon     intubation have an influence on the clinical outcome and success rate of the surgical     treatment. Microbiological specimens are taken from conjunctiva and nasal mucosa during the     two procedures under general anaesthesia and from the silicon tube after removal and examined     for bacterial contamination.   "
189478|NCT00312702|"     Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of     America.   "
189479|NCT00312715|"     This study will use a technique called microperfusion to examine how thyroid hormones are     involved in fat metabolism. The thyroid gland produces two kinds of hormones: T3 and T4. Some     of the T4 is changed to T3 in various organs after leaving the thyroid. The T3 stimulates the     body to burn fat. People have different rates at which they can change T4 to T3, and this may     lead to differences in body fat among different people.      Microperfusion is based on the exchange of substances across tiny holes of a small plastic     tube called a probe, which is inserted after numbing the skin over a fat pad. Through these     openings, the fat pad is continuously rinsed with small amounts of fluid, and an exchange of     substances occurs. The fluid drips from the other opening of the probe and is collected in a     vial. Small amounts of study drugs are infused and the amount of substances released by the     fat pad in response to them are measured.      Healthy normal volunteers 18 years of age and older may be eligible for this study.     Candidates are screened with a medical history, physical examination and blood tests.      Participants undergo microperfusion. A needle is placed in an arm vein for collecting blood     samples before and at the end of the experiment for measuring thyroid hormones and other     substances in the blood. The skin over the fat pad next to the umbilicus (navel) is numbed     and two microperfusion probes are inserted. A salt water solution is infused into the fat pad     for one hour and the substances in the fluid are measured as the fluid leaves the fat pad.     After 1 hour isoproterenol, a drug that aids in energy production by fat, is added to help     determine the level of fat metabolism. After an additional hour small amounts of thyroid     hormone are added to the fluid and samples are collected as they leave the body. Two     catheters are inserted during each experiment. Small volumes of sterile fluid are circulated     continuously in the tubing and samples are collected at regular intervals.   "
189480|NCT00312728|"     This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with     first- or second-line therapy in patients with metastatic non-squamous non-small cell lung     cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of     115 patients enrolled in the study.   "
189482|NCT00312754|"     The purpose of this clinical research study is to learn if BMS-232632 administered as     Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including     Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated     vasodilatation (FMD), in HIV-infected patients. The safety of this treatment will also be     studied.   "
189483|NCT00312767|"     People with Fabry disease have an alteration in their genetic material (DNA) which causes a     deficiency of the a-galactosidase A enzyme. Fabrazyme is a drug that helps to breakdown and     remove certain types of fatty substances called glycolipids. These glycolipids are normally     present within the body in most cells. In Fabry disease, glycolipids build up in various     tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not     present, or is present in small quantities. The build up of glycolipid (globotriaosylceramide     or GL-3) levels in these tissues in particular is thought to cause the clinical symptoms that     are common to Fabry disease. This study is designed to verify that no loss of Fabrazyme     occurs during simultaneous Fabrazyme infusion and hemodialysis in patients currently     receiving Fabrazyme at a dose of 1.0 mg/kg every 2 weeks.   "
189484|NCT00312780|"     This clinical study is being conducted at multiple sites to determine the activity, safety     and tolerability of XL784 when given daily to patients with albuminuria due to diabetic     nephropathy. XL784 is a small molecule reno-protective metalloproteinase inhibitor,     inhibiting both ADAMs (including ADAM10, a target of significant interest because of its     important role in blood vessel formation and cell proliferation, and ADAM17/TACE, activation     of which has been associated with renal deterioration) and MMPs (including MMP-2 and MMP-9).     XL784 was specifically optimized to be MMP-1 sparing, which may be clinically significant     because inhibition of MMP-1 has been hypothesized to be associated with musculoskeletal     toxicity.   "
189485|NCT00312793|"     This study is designed to evaluate the efficacy and safety of Myospare, a non-invasive     device, which is connected to the body via electrodes placed in the injured leg. The     electrodes which are placed in the middle or upper thigh will stimulate the quadriceps     muscle.      Myospare will be installed 1 day after the anterior cruciate ligament (ACL) reconstruction     surgery and will be removed after 6 weeks of treatment. The patients will be assigned to two     groups:        1. Physiotherapy plus Myospare        2. Only physiotherapy      The hypothesis of the study is that electrical stimulation combined with voluntary exercise     is more effective than voluntary exercise alone.   "
189486|NCT00312806|"     The aim of the present study is to identify factors (such as symptom patterns and symptom     scores) that influence the response to treatment with pantoprazole using different evaluation     methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole     will be administered once daily in the morning at one dose level. The study duration consists     of a treatment period of 8 weeks. The study will provide further data on safety and     tolerability of pantoprazole.   "
189487|NCT00312819|"     Recent studies in laboratory animals demonstrate the ability of disulfiram to significantly     inhibit the growth and metastasis of a mouse model of lung cancer. Work with cells in vitro     support the idea that this inhibition is mainly due to the inhibition of angiogenesis - the     formation of new blood vessels in the tumor. Furthermore, it was found out that the best     effect has been obtained when disulfiram has been used not at the highest dose but at an     optimal dose, which is smaller. Thus, this trial will assess the addition of disulfiram to     chemotherapy in non-small cell lung cancer (NSCLCA).   "
189488|NCT00312832|"     Background: Stavudine-containing regimens are associated with a potential for lipoatrophy and     dyslipidemia. We assessed the safety and efficacy of reducing the dose of stavudine compared     to switching to tenofovir or maintaining the standard dose of stavudine.      Methods: Clinically stable lipoatrophic HIV-infected patients receiving antiretroviral     therapy containing stavudine 40 mg bid with a plasma HIV RNA <200 copies/mL for at least 6     months were randomized to maintain stavudine 40 mg bid (d4T40 arm), to reduce to 30 mg bid     (d4T30 arm), or to switch from stavudine to tenofovir-DF (TDF arm) while preserving the     remaining drugs. Fasting metabolic parameters were assessed at baseline and at weeks 4, 12,     and 24. Mitochondrial parameters in peripheral blood mononuclear cells and body composition     were measured at baseline and at week 24.   "
189489|NCT00312845|"     The purpose of this study is to determine if the combination of VELCADE and rituximab     improves progression free survival relative to rituximab alone in patients with relapsed or     refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have     previously responded to rituximab. This is an international study being conducted in the     United States and in many countries around the world. A complete list of study locations is     listed below.   "
189490|NCT00312858|"     Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and     varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together     with measles, mumps, rubella, and varicella [Oka/Merck] virus vaccine at the second dose.     Immunogenicity and safety data will be collected after each dose of vaccine.   "
189491|NCT00312871|"     The purpose of the study is to assess the effect of an early and complete correction of     anemia after treatment with epoetin alfa on the rate of progression of chronic renal failure     (which involves improper functioning of the kidneys). It also assesses the effect of     hemoglobin normalization (correction of anemia) on the need for renal (kidney) replacement     therapy, quality of life, blood pressure control, hospital admissions, mortality,     cardiovascular events, nutritional status and safety.   "
189517|NCT00313209|"     The aim of the study is to compare the efficacy of roflumilast on pulmonary function and     symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during     concomitant administration of salmeterol. The study duration will last up to 28 weeks. The     study will provide further data on safety and tolerability of roflumilast.   "
189518|NCT00329914|"     The purpose of the study is to determine whether a daily dose of 200 mg progesterone     administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm     delivery amongst twin pregnancies.   "
189519|NCT00329927|"     To evaluate the antibody response to each influenza vaccine antigen when administering a     single dose to subjects aged 65 years and over   "
189520|NCT00329940|"     The purpose of this study is to assess rheumatologic tolerability of letrozole in     postmenopausal patients with hormone receptor positive breast cancer having discontinued     anastrozole adjuvant treatment due to musculoskeletal disorders.   "
189492|NCT00312884|"     This project, using home monitoring for the signs and symptoms of heart failure, aims to     empower patients to be actively involved in their care and provide rapid access to healthcare     services and advice when needed. The telemonitoring system is easy to use and ensures the     accurate transfer of information from the home to the hospital. The information is then     screened and if important changes are seen, the patient will be contacted by a heart failure     nurse who will offer advice and may arrange a clinic visit or suggest alterations to the     medication. The project uses modern technology to provide disease management, links the     patient in their home with the hospital and reinforces education and self-care behaviour.     This innovative programme will be tested to see if it reduces the risk of re-admission to     hospital, reduces anxiety, improves quality of life following a hospital admission for heart     failure and whether this represents good value for money in terms of the health benefits it     provides.      Hypothesis:      Patients using home telemonitoring of signs and symptoms of heart failure following discharge     from hospital with chronic heart failure have a reduced risk of all-cause re-hospitalisation     when compared with usual care.   "
189493|NCT00312897|"     Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of     adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of     omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1)     change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the     end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end     of 10-week treatment.      Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant     reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at     the end of treatment compared to placebo.   "
189494|NCT00312910|"     The purpose of this study is to determine whether probiotics are effective in the prevention     of the complications of liver cirrhosis.   "
189495|NCT00312923|"     Lay Language Summary: High cholesterol levels are common in persons with HIV infection.     However, conventional cholesterol-lowering medications may have harmful side effects when     given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of     policosanol, a dietary supplement derived from sugar cane that has cholesterol-lowering     properties, to lower cholesterol levels in persons with HIV infection. We hypothesize that     policosanol will lower levels of LDL cholesterol (bad cholesterol) and raise levels of HDL     cholesterol (good cholesterol).   "
189496|NCT00312936|"     We are exploring the effect that an 8 week stress reduction program based in mindfulness     practices will have on the experience of medication side effects reported by HIV-infected men     and women taking antiretroviral therapy.   "
189497|NCT00312949|"     This study will evaluate the effectiveness of an interactive educational website in enhancing     discussions about treatment issues and improving the quality of care for people with     schizophrenia.   "
189498|NCT00312962|"     This study will determine the effectiveness of reward-intensive, computer-based targeted     cognitive training in improving neurocognitive deficits in people with schizophrenia.   "
189499|NCT00312975|"     The purpose of this trial is to study how long patients can remain progression free when they     receive CP-675,206, compared to how long patients can remain progression free when they     receive best supportive care. If you choose to take part, you will be randomized to receive     either CP-675,206 as maintenance therapy or best supportive care. Best supportive care means     you will not receive any study drug or other treatment for your cancer. Best supportive care     could include treatment with antibiotics, analgesic drugs (medicine for pain), blood     transfusions or psychosocial and nutritional support, depending on your needs. You have a 50%     chance of being randomized to receive CP-675,206.   "
189500|NCT00312988|"     Determination of total survival under Topotecan Monotherapy, Topotecan + Etoposide and     Topotecan + Gemcitabine in second-line therapy in patient with recurrent ovarian cancer.   "
189501|NCT00313001|"     This trial is conducted in the United States of America (USA). The study will compare A1C     reduction achieved in patients receiving biphasic insulin aspart 70/30 once or twice daily to     patients receiving exenatide twice daily. Patients enrolled in the study will be insulin     naive patients who have not achieved glycemic control with metformin and sulfonylurea.   "
189502|NCT00313014|"     The objective of this study is to demonstrate the effectiveness and tolerability of the     buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal     system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back     pain currently treated with oral opioids. The double-blind treatment intervention duration is     12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will     be provided to all subjects in addition to study drug.   "
189503|NCT00313027|"     The purpose of this study is to determine the value of novel non-invasive medical imaging     methods for detecting the spread of head and neck squamous cell carcinoma to the lymph nodes     in the neck by comparing their results to findings at the time of surgery.   "
189539|NCT00330226|"     The purpose of this study is to investigate the efficacy and safety of long-term     psychopharmacotherapy in schizophrenia or bipolar disorder in terms of psychopathology and     side effects.   "
189504|NCT00313040|"     Recent research suggests that overweight persons who are physically active may be     significantly less likely to develop health complications and less likely to die early when     compared even with lean persons who are not physically active. Previous treatment programs     for people who have struggled with their weight have focused almost entirely on weight loss     as the main goal of treatment. Our research program has a different focus. We hope to improve     health and healthy self esteem independent of body weight by focusing instead on increasing     physical activity as the main goal of treatment. This is a small study designed to see if     this approach would be appealing to persons who are struggling with their weight who are     currently sedentary. It is designed for people who are otherwise fairly healthy for whom     exercise is reasonably safe. Participants are randomly (by chance) assigned to participate in     the experimental treatment program or instead to meet with their regular primary care doctor.     Those who are assigned to meet with their regular doctor can access traditional weight loss     resources such as Weight Watchers, Jenny Craig, Fitness centers etc... After the experiment     is complete, these participants will have the opportunity to participate in the experimental     treatment program.   "
189506|NCT00313066|"     Connective tissue growth factor (CTGF) is known to be a fibrogenic cytokine, it could be     expressed in various fibrosis diseases. But, recent research showed that CTGF also be     considered to be a tumor suppressive gene. The expression of CTGF protein is higher in normal     Type I and II alveolar epithelial cells than metastatic tumor cells. CTGF appears to be a     suppressor of lung tumor invasion and in metastasis and the decreased CTGF expression in     tumor tissues was associated with advanced tumor stage, lymph node metastasis, early     postoperative relapse and shorter patient survival.      CTGF can be expressed in many human organs such as heart, brain, placenta, liver, muscle,     kidney, peritoneal mesothelial cells and lung but did not known in the pleura. The CTGF     protein is present in the peritoneal cavity and is increased during peritonitis. Considering     pleural cavity comes from the same origin of mesenchyma with peritoneum, pericardium and     fallopian tube, we aim to evaluate whether the CTGF expression increase in the pleurisy     patients including the parapneumonic effusion and the TB pleurisy.      The diagnosis of TB pleurisy depends on the effusion TB culture and pleural biopsy.     Unfortunately the sensitivity of TB culture was only 20-30%. So most patients must receive     invasive pleural biopsy. Adenosine deaminase(ADA) was developed as a screening test but     should not be considered an alternative test to culture and biopsy. The sensitivity of ADA     might vary from 32%-100% and the cutoff value also vary from 26 to 70 IU/L. We should develop     a method to alternate the culture and biopsy . Therefore, our technologist Jao-Jia chu will     develop the CTGF ELISA kit for this specific aim. If CGTF might increase expression in     pleuritis but decrease in pleural metastasis, it might be a potential method help to     differentiate lymphocytic pleural effusion between TB pleurisy and malignancy.   "
189507|NCT00313079|"     A phase I trial in patients with relapsed or refractory leukemia of a human monoclonal     antibody that kills B cell acute lymphoblastic leukemia. Trial will study safety,     pharmacokinetics, and anti tumor activity of the antibody given as a single agent and with     vincristine.   "
189508|NCT00313092|"     The aim of the study is to determine if plasma matrix-metalloproteinase activity can predict     glaucoma in patients with OSAS and if the level of plasma matrix-metalloproteinase activity     will decrease after one month of nCPAP-treatment.   "
189509|NCT00313105|"     To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking     cessation compared with a control group with low dose nicotine patches.      Also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½     year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure,     lung function and body weight every 6 months for 2 years.   "
189510|NCT00313118|"     Determination of the mean value of oxidative stress parameters in normals and of the plasma     and serum levels, resp. of malondialdehyde, glutathion and superoxide dismutase in healthy     subjects.   "
189511|NCT00313131|"     This randomised controlled trial aimed to verify whether directly observed single dose     treatment (with tinidazole+fluconazole) would be as effective as the longer standard     treatments (metronidazole for 7 days, plus vaginal clotrimazole for 3 days) in the syndromic     management of women presenting with vaginal discharge in primary health care centers of     Ghana, Togo, Guinea and Mali. It was designed as an effectiveness trial, i.e. it was done     under conditions typical of routine work in these health centers   "
189512|NCT00313144|"     The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are     to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are     initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related     quality of life (HRQoL), healthcare resource utilization (HCRU), and various laboratory     analyses to evaluate the safety of long-term administration of ARALAST.      Up to 120 subjects will be enrolled and assessed for HRQoL and HCRU at baseline and every     6-months thereafter, for 2 years. A subset of subjects will be enrolled into the blood draw     portion of the study, which will also include assessments of antibodies to ARALAST, and     chemistry panel. Subjects will be treated according to the prescribing (attending)     physician's instructions based on the prescribing information given in the ARALAST package     insert.   "
189513|NCT00313157|"     The purpose of this study is to compare the effect of metoprolol, verapamil, diltiazem and     carvedilol on ventricular rate, working capacity and quality of life in patients with chronic     atrial fibrillation.   "
189514|NCT00313170|"     This study will assess the relationship between fulvestrant dose and efficacy in     postmenopausal women with oestrogen receptor positive advanced breast cancer.   "
189515|NCT00313183|"     This study will be the first evaluation of Symlin in adolescent subjects with type 1 diabetes     mellitus and is designed to evaluate the blood levels (pharmacokinetics), biochemical and     physiological effects (pharmacodynamics), and safety and tolerability of Symlin in these     subjects.   "
189627|NCT00331526|"     RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the     immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate     the white blood cells, including lymphokine-activated killer cells, to kill tumor cells.     Giving cellular adoptive immunotherapy during or after surgery may kill more tumor cells.      PURPOSE: This phase II trial is studying how well cellular adoptive immunotherapy works in     treating patients with glioblastoma multiforme.   "
189677|NCT00332241|"     This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly     dosed with a placebo, in reducing serious behavioral problems in children and adolescents     with a diagnosis of autistic disorder (AD).   "
189516|NCT00313196|"     The study will assess the effect of bosentan on pulmonary vascular resistance and exercise     capacity in Sickle Cell Disease (SCD) patients diagnosed with Pulmonary Hypertension. It     consists of 3 phases: screening, treatment and follow-up. During the screening visit, the     study doctor will decide if patients meet the study requirements. All potential patients will     have a diagnosis of increased pulmonary artery pressures that is shown by right heart     catheterization conducted shortly prior to start of study treatment. Patients will be asked     to perform exercise capacity test (walking as far as possible for 6 minutes). Following the     baseline visit the treatment phase consists of 4 additional clinic visits during which the     good and bad effects of the drug are reviewed and exercise capacity test will be repeated.     Patients will be treated for 16 weeks. Blood samples will be collected every month, or more     often, if needed. At the end of the study some of the patients will be asked to repeat the     right heart catheterization. All patients will repeat an exercise capacity test. After     completion of the study, patients will have the option of enrolling in a long-term follow-up     study where all patients will receive active drug. Patients electing not to participate in     the extension study will be followed up for safety assessments for about 28 days after the     end of the study treatment.   "
189521|NCT00329966|"     To evaluate the antibody response to each influenza vaccine antigen when administering a     single dose to subjects aged 18 years and over   "
189522|NCT00329979|"     Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain     injury could occur at an unexpectedly high rate. One study has found that up to 22% of     patients with severe aortic stenosis who have undergone retrograde catheterization of the     valve can be identified as having new ischemic lesions as detected by diffusion-weighted (DW)     magnetic resonance imaging (MRI). During cardiac catheterization, cerebral microembolism as     detected by TCD has frequently been observed, but whether it is clinically relevant remains     unknown . However, recent studies have suggested that some of these microemboli could be     responsible for acute brain injury, as documented by DW MRI.      Indeed the high sensitivity of DW MRI suggests that this technique could allow an improved     estimate of cerebral ischemic events associated with cardiovascular-catheter procedures. We     therefore decided to perform DW MRI before and after cardiac catheterization to prospectively     assess both clinically silent and apparent cerebral embolisms for the first time in a     multicenter trial. Furthermore, a randomization between radial and femoral access will allow     assessment of risk of silent brain injury associated with the different vascular access     sites.   "
189523|NCT00329992|"     Participants are randomly assigned to either 16 sessions of Brief Eclectic Psychotherapy     (Gersons et al. (2000) Journal Trauma Stress 13: 333-348), comprising psychoeducation,     exposure, mementos and writing assignments, domain of meaning and integration, farewell     ritual, or a minimal attention control group that will be offered 16 sessions of BEP after a     waiting time of four months. Participants in the minimal attention control group receive     monthly telephone calls and complete a symptom self monitoring diary (Tarrier, N. et al.     (1999) Behavior Therapy 30: 597-605) for three weeks.   "
189524|NCT00330005|"     The purpose of this study was to compare a group psychotherapy intervention, the Integrative     Outpatient Model, to a convenience control, in adults with bipolar disorder.   "
189525|NCT00330018|"     The rationale for this protocol is based on the need to assess if the current post stem cell     transplantation CMV prophylaxis strategies (e.g. high-dose acyclovir plus pre-emptive     treatment) can be improved by the use of valganciclovir. CMV is the most common viral     infection following stem cell transplantation, causing significant morbidity and mortality.     Furthermore, CMV has been shown to be associated with a number of indirect effects in SCT     recipients including allograft dysfunction, acute and chronic graft versus host disease     (GVHD). Valganciclovir is shown to be more active than oral ganciclovir, and as good as     intravenous (i.v.) ganciclovir in treating newly diagnosed CMV retinitis. The use of     valganciclovir for CMV prophylaxis post stem cell transplantation was never tested in     controlled study. The investigators therefore suggest a prospective, randomized study to     evaluate the efficacy and safety of valganciclovir compared with acyclovir for prevention of     CMV disease in allogeneic stem cell transplantation recipients.   "
189526|NCT00330044|"     To determine the safety of Alimta when used with chemoradiation in inoperable non small cell     lung cancer   "
189527|NCT00330070|"     The purpose of the study is to determine whether IPL512,602 is safe and effective for the     treatment of asthma symptoms in patients who remain symptomatic on a background therapy of     inhaled corticosteroids.   "
189528|NCT00330083|"     This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults   "
189554|NCT00330525|"     Control of food intake, size and frequency of meals are critical to the development of     obesity. The stomach signals feelings of fullness after a meal and therefore plays a role in     control of calorie intake. It is unclear whether the approved appetite reducing drug     sibutramine changes the function of the stomach. Differences in the way individuals respond     to treatment with the appetite suppressant sibutramine may also explain why some people lose     weight while others do not.      This single center clinical study aims to compare functions of the stomach in healthy,     overweight and obese individuals, and to evaluate the effects of the FDA-approved appetite     suppressing medication sibutramine on weight loss and stomach functions in patients who are     overweight or obese. The effect of individual differences in inherited genes on weight     reduction with sibutramine will be tested.   "
189529|NCT00330096|"     Fruits and vegetables are rich in a variety of flavonoids with antioxidant properties. These     compounds may be partially responsible for some of the positive links found between fruits     and vegetables intake and higher bone mineral density in adults and children. Several animal     studies have shown that consumption of onions (which are rich in quercetin), rutin (a     quercetin glycoside) and resvatrol (found in red wine) inhibits ovariectomy induced bone loss     in rats. One of the most studied flavonoids with respect to bone health is the soy     isoflavones. However, consumption of soy products is relatively low in Western countries. One     the other hand, a flavonoid such as hesperidin, found mostly in oranges is much more abundant     in the Western diet. Citrus juice consumption has been demonstrated to prevent bone loss in     male orchidectomized rats while specifically feeding hesperidin has been shown to prevent     bone loss in ovariectomized mice and rats. However, to date no clinical prove has been     obtained for these benefits.Therefore the aim of this study is to investigate the effect of     hesperidin in preventing bone loss in postmenopausal women. This study is designed as a     2-year, double blind, placebo-controlled, two arm, and parallel group study. The primary     outcome measure is change in bone mineral density (BMD) while the secondary outcome measures     are changes in bone resorption and formation markers as well as body composition. The women     are randomised to consume 2 servings of hesperidin-rich food or food without hesperidin but     with the same taste & appearance (placebo). Subjects will undergo medical screening,     anthropometry, physical activity, dietary assessments and BMD before randomisation into     placebo or active group. Follow-up measurements are made at 3-month intervals (for blood and     urine collection) and 6-month intervals for bone mineral density. Side effects are also being     monitored during each visit.   "
189530|NCT00330109|"     Gliomas are one of the most challenging tumors to treat, because areas of the apparently     normal brain contain microscopic deposits of glioma cells; indeed, these occult cells are     known to infiltrate several centimeters beyond the clinically apparent lesion visualized on     standard computer tomography or magnetic resonance imaging (MR). Since it is not feasible to     remove or radiate large volumes of the brain, it is important to target only the visible     tumor and the infiltrated regions of the brain. However, due to the limited ability to detect     occult glioma cells, clinicians currently add a uniform margin of 2 cm or more beyond the     visible abnormality, and irradiate that volume. Evidence, however, suggests that glioma     growth is not uniform - growth is favored in certain directions and impeded in others. This     means it is important to determine, for each patient, which areas are at high risk of     harboring occult cells. We propose to address this task by learning how gliomas grown, by     applying Machine Learning algorithms to a database of images (obtained using various advanced     imaging technologies: MRI, MRS, DTI, and MET-PET) from previous glioma patients. Advances     will directly translate to improvements for patients.   "
189531|NCT00330122|"     The fractures of the wrist, affecting the distal end of the radius are frequent, in     particular in the old subject and/or osteoporotic. Beside the simple fractures treated by     mini-invasive surgical methods, there is a considerable number of strong comminuted fractures     for which no method of osteosynthesis proves completely satisfactory, especially on     osteoporotic bone. However, the restitution of the anatomy remains the principal concern of     the surgeon eager to ensure a good functional result to its patient, with the proviso that     the least aggressive possible method is used.      Until now, it is of use to rather largely use the external fixer bridging the radiocarpal     articulation to maintain the length of the radius, more or less associated with an another     method of internal osteosynthesis with minima. The major disadvantage of this kind of     assembly is the high rate of neuroalgodystrophic syndromes of the wrist and losses of     reduction, sometimes generators of painful after-effects and serious stiffening. These     after-effects which are sometimes definitive can be very disabling when they occur among     active people, a fortiori when they touch the dominant side.      The recent alternative to the use of the external fixer is the use of the plates with locking     screws, affixed on the foreface of the radius, maintaining the length of the radius but not     bridging the articulation. Thus, this kind of osteosynthesis does not generate ligamentary     distraction nor of the radiocarpal capsule, factors which would be prevalent in the release     of the algodystrophy and of the stiffening. On the other hand, this method of osteosynthesis     is more invasive than the installation of an external fixer, because it requires the access     of the foreface of the radius and cannot be practised in a percutaneous way. At present,     there is any randomized comparative study, the published studies being only comparative     retrospective and not controlled, carried out on nonhomogeneous series of fractures.      The principal objective of our study is to evaluate the interest of the locking plates in the     maintenance of the radial length in the comminuted fractures of the distal end of the radius.      It is about a prospective, multicentric, randomized study in 2 parallel groups carried out     patients from 40 to 80 years hospitalized in a service of Osseous Surgery.      Patients: articular displaced fractures of the lower end of the radius with strong metaphysar     comminution (groups M3 and M4 of the classification MEC) with an important shortening of the     radius, measured by a radio-ulnar index higher than 4 mm compared to the opposite side. Are     excluded the articular explosions type E4. The patients of more than 40 years, autonomous and     active, able to give an assent for the participation in a clinical study are included.      Treatment. The first group of patients would be treated by fore locked plate possibly     associated with pins. The immobilization would be limited to a antibrachiopalmar splint for     45 days. If, peroperatively, a sufficient stability of the fracture cannot be obtained by the     plate alone, and that a complementary stabilization by fixer proves to be necessary, then the     case will be entered like a failure of stabilization by locked plate.      The second group of patients would be treated by external radiocarpal fixer in neutralization     possibly associated with an internal osteosynthesis with minima (percutaneous pins). The     fixer would be left in place during 45 days.      The reeducation would consist in the 2 groups of an active mobilization of the fingers at the     beginning, then of an active reeducation of the wrist in flexion/extension and     pronosupination starting from the 45th day.      About fifty patients should be included in each group, with a collection of the clinical and     radiographic results at 21 days, 45 days, 3 months and 6 months.   "
189532|NCT00330135|"     To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium     hyaluronate and placebo following an intra-articular injection in patients with symptomatic     osteoarthritis of the hip.      Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic     hip and will be followed up for three months.      At the third month, if the score for overall pain is still > 40 mm on the VAS, a second     injection of ADANT® can be given irrespective of which treatment was received previously. The     patient will be followed up for a further 3 months in an open-label fashion (monthly visits).   "
189533|NCT00330148|"     The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on     two molecules officially registered: melarsoprol, the most commonly used, has a poor safety     profile and is becoming ineffective due to parasite resistance; and eflornithine, with better     tolerance but more complicated and expensive to implement in endemic countries. nifurtimox,     registered only for Chagas' disease but used off-label since the 1970’s in series of cases of     HAT, is at present the only other available alternative.      The very limited number of compounds available, the lack of prospects for the development of     new products and the emergence of resistance are arguments for the use of therapeutic     combinations.      This study evaluates the efficacy and safety of three drug combination therapies:     melarsoprol-nifurtimox, melarsoprol-eflornithine and eflornithine-nifurtimox.   "
189534|NCT00330161|"     This phase II trial is studying how well vorinostat works in treating patients with     progressive metastatic prostate cancer. Drugs used in chemotherapy, such as vorinostat, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
189535|NCT00330174|"     STUDY OBJECTIVES:      The primary objective of this study is to compare the safety and efficacy of acamprosate     versus placebo in the treatment of alcohol dependence in adults with co-occurring mood or     anxiety disorders (specifically, depression (MDE), generalized anxiety disorder (GAD) or     social anxiety disorder). Secondary objectives are to evaluate the effect of acamprosate     treatment on mood and anxiety disorders.      STUDY DESIGN:      This is a randomized, double-blind, placebo-controlled trial evaluating acamprosate in the     treatment of alcohol dependence in adult outpatients with concurrent mood and/or anxiety     disorders. The active study phase will be 12 weeks in duration. There will be a two-week     screening period, followed by 12 weeks of study medication and a follow-up assessment at 14     weeks from randomization.      STUDY POPULATION:      A total of 90 (30 per site) men and women aged 18-60 years who have a current diagnosis of     alcohol dependence as well as a current DSM-IV diagnosis of either MDE, GAD and/or social     anxiety will be recruited to participate in this study. Only those individuals whose     psychiatric disorders are stable will be randomized to acamprosate or placebo. Three sites     will participate in this trial.      TREATMENTS:      Eligible participants will be randomly assigned to receive either acamprosate or matching     placebo for 12 weeks.      EFFICACY ASSESSEMENTS:      The primary efficacy outcome measure will be cumulative days abstinent as measured by     self-report.   "
189536|NCT00330187|"     In the current proposal, we intend to study the efficacy of bupropion SR with or without     combined contingency management (CM) among adolescent cigarette smokers. The proposed study     will test not only medication (bupropion SR), but also combination of medication and CM in     potentially improving smoking cessation outcomes AND retention of adolescent smokers in the     study.      Hypothesis to be tested: Bupropion SR treatment will increase abstinence from cigarette     smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as     compared to treatment with placebo only.      Hypothesis to be tested: Adolescent smokers treated with combined bupropion SR + contingency     management (CM) treatment will have increased retention and increased abstinence rates when     compared to bupropion SR alone or CM + placebo treated groups (as measured by decreased     drop-out of participants, urine cotinine and continuous abstinence).      Hypothesis to be tested: CM will increase the abstinence from cigarette smoking (as measured     by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment     with placebo only.   "
189540|NCT00330239|"     Pharmacotherapy has demonstrated efficacy in a number of controlled trials in the treatment     of PTSD. The selective serotonin reuptake inhibitors have proven particularly useful in     treating this disorder. Currently there are two selective serotonin reuptake inhibitors     (Zoloft® and Paxil®), that have been FDA approved for treating PTSD. Coincidentally, this     same class of medications has also been shown to have efficacy in some trials in decreasing     alcohol consumption in heavy drinkers. The goal of the proposed study is to preliminarily     investigate the efficacy of Paxil® (paroxetine), in decreasing symptoms of PTSD as well as     decreasing substance use, in individuals with concurrent substance dependence and PTSD. The     type of paroxetine used in this trial will be Paxil CR®, which is a sustained release     formulation of paroxetine, which has fewer side effects and greater tolerability. This is a     particularly important issue in substance using populations because medication compliance is     generally poor.      Two specific hypotheses will be tested. 1) Individuals who receive Paxil CR® will have a     greater improvement in their PTSD symptoms (based on CAPS-2 and CGI) than those who receive     placebo. 2) Individuals who receive Paxil CR® will have greater improvement in their     substance use outcomes (based on UDS and TLFB) than will those who receive placebo.   "
189541|NCT00330252|"     The purpose of this study is to determine whether the combination of alemtuzumab and     rituximab is safe and effective in treating patients with relapsed Chronic Lymphocytic     Leukemia (CLL) and to determine whether alemtuzumab can be given as a single weekly     subcutaneous dose, together with rituximab.   "
189542|NCT00330265|"     The objective of this study is to determine the safety and effectiveness of a device (the     KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as     compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2     diabetes mellitus.      This is a prospective, randomized, multi-center, unmasked, controlled study. All patients     will receive care for the diabetic foot ulcer during the study.      Participation in the study is for 24 weeks.   "
189543|NCT00330278|"     This is a randomized, double-blinded placebo controlled trial of cefazolin timing before     cesarean section fo infection prophylaxis. Subjects are randomized to cefazolin either 30     minutes prior to skin incision or at time of cord-clamping. Primary outcome is infectious     morbidity including wound infections and endometritis.   "
189544|NCT00330395|"     The purpose of this study is to test the amount of caspofungin found in the blood of neonate     and infants <3 months of age following treatment with caspofungin at 25 mg/m2. Another     purpose is to test the safety of caspofungin in treating neonates and infants with Candida     infections (a certain type of fungal infection).   "
189545|NCT00330408|"     This study aims to assess the impact of training General Practitioners (GPs) on adherence to     antihypertensive medication among hypertensive individuals. It also aims to assess risk     factors for non-adherence. Special training (in appropriate algorithms for management and     patient involvement in therapeutic decision making) has been given to GPs. The study has been     conducted in six middle or low income clusters of Karachi recruiting individuals randomized     to specially trained or untrained GPs, with a follow-up period of 6 weeks. The medication     event monitoring system (MEMS)has been used for assessing adherence. It is hypothesized that     compliance levels of individuals going to specially trained GPs is higher compared to those     going to GPs not having received special training.   "
189546|NCT00330421|"     This phase II trial is studying how well sorafenib works in treating patients with soft     tissue sarcoma. Sorafenib may stop the growth of soft tissue sarcoma by blocking blood flow     to the tumor and blocking some of the enzymes needed for tumor cell growth   "
189547|NCT00330434|"     The two purposes of this study are        1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages          has             1. on the blood level of bupropion and chlorzoxazone and their major breakdown               products in the blood and             2. on the stimulant effect of bupropion and        2. to determine what effect a normal and common (25% frequency) genetic variation of a          specific liver enzyme (that breaks down bupropion) has             1. on the blood levels of bupropion and its major breakdown products in the blood and             2. on the stimulant effect of bupropion.      Two groups of volunteers will be recruited for this study:        1. volunteers who drink moderate to heavy amounts of alcohol frequently and        2. volunteers who usually do not drink alcohol.      Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the     study.   "
189548|NCT00330447|"     The researchers aim to investigate the outcome (overall survival) of mothers who are     diagnosed and/or treated for cancer during pregnancy. Furthermore they want to test the     hypothesis that children who were exposed to cytotoxic drugs in utero, or radiotherapy,     develop normally (neurologic and cardiologic examination).   "
189549|NCT00330460|"     The purpose of this study is to determine whether in postmenopausal women with low bone     mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is     not less than that observed in subjects receiving alendronate sodium by more than a     pre-specified non-inferiority margin.   "
189550|NCT00330473|"     A study to compare insulin use and its effect on glucose control and other outcomes in     patients with Type 2 diabetes who together with their healthcare provider manage their     disease by discussing and agreeing on the diabetes treatment chosen from a selection of     available treatment options.   "
189551|NCT00330486|"     The purpose of this study is to determine whether acamprosate (Campral) is safe and effective     in treating alcohol dependence in individuals with bipolar disorder. All subjects in the     study must be currently stabilized on mood-stabilizing medication. Half of the subjects will     receive acamprosate in addition to their mood-stabilizing medication; control subjects will     be maintained on their mood-stabilizing medication alone. Measures of alcohol use as well as     mood stability will be obtained weekly throughout the active phase of the study.   "
189552|NCT00330499|"     The purpose of this study is to define the optimal management of localised transitional cell     carcinoma (TCC) of the urinary bladder. The main objective is to evaluate whether     chemoradiation is superior to radiotherapy alone.   "
189553|NCT00330512|"     About 20-25% of deliveries are by cesarean section. Most are elective with use of regional     anesthesia (spinal/epidural). Drop of blood pressure after regional anesthesia is common. It     have the risk of reduction of blood flow to the placenta and the fetus.      No studies had followed the newborns their first days of live,of mothers who developed     hypotension in durins CS.   "
189557|NCT00330564|"     The goal of this clinical research study is to learn if sunitinib malate (SU011248) can help     to control VHL. The safety of this drug will also be studied.      Primary objectives:        -  Evaluate safety of treatment with SU011248/sunitinib malate (50 mg daily dose for 4          weeks, then 2 weeks off) for 6 months in patients with Von Hippel-Lindau Syndrome (VHL)          who have a measurable lesion undergoing surveillance      Secondary objectives:        -  Evaluate efficacy of treatment with SU011248/sunitinib malate (50 mg daily dose for 4          weeks, then 2 weeks off) for 6 months in patients with VHL who have a measurable lesion          undergoing surveillance      Correlative objectives:        -  Evaluate quality of life of SU011248/sunitinib malate therapy in VHL patients        -  Evaluate peripheral blood lymphocyte receptor phosphorylation in VHL patients taking          SU011248/sunitinib malate (optional procedure)        -  Correlate results of dynamic contrast-enhanced and diffusion weighted MRI and dynamic          contrast enhanced CT with response and explore findings suggestive of surrogates of          early response (optional procedure)   "
189558|NCT00330577|"     The purpose of this study is to compare the short-term mean 24-hour intraocular pressure     control, 24-hour blood pressure effect and safety of Latanoprost/Timolol fixed combination     given once in the evening with placebo once in the morning versus timolol maleate 0.5% given     twice daily in patients with ocular hypertension and primary open-angle glaucoma.   "
189579|NCT00330850|"     The purpose of the study is to show the efficacy of a single dose of PRO-513 for treating     subjects suffering moderate pain form a migraine attack, with or without aura. The study is     also intended to show the effectiveness of PRO-513 for associated symptoms of nausea,     photophobia, and phonophobia due to a migraine attack.   "
189580|NCT00330863|"     This study is designed to find out whether taking antipsychotic medication once every two     weeks by injection compared to taking daily oral medication will help people with     schizophrenia maintain better control of their symptoms.   "
189581|NCT00330876|"     This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with     hypercholesterolemia or combined dyslipidemia.   "
189582|NCT00330889|"     This study will assess the Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of     Prednisolone on Rheumatoid Arthritis (RA) patients.   "
189559|NCT00330590|"     The investigators have developed a new device for guiding invasive procedures with ultrasound     (US), which they call the sonic flashlight (SF). They attach a half-silvered mirror and a     small flat-panel monitor directly to an ultrasound transducer to project a virtual image of     the US scan into its actual location within the patient. This permits the operator to guide a     needle through the skin by aiming directly at the image, using natural hand-eye coordination     rather than looking away from the patient at a conventional display. The device requires no     tracking or head-mounted apparatus, and provides an intuitive merger of the visual exterior     of the patient with an in situ ultrasound image, which can be simultaneously viewed by others     assisting the operator. The investigators believe the SF will increase the accuracy, safety,     and speed for a wide variety of invasive procedures, and will require less extensive training     than conventional US displays.      Given the wide variety of procedures for which the SF could be used, the investigators have     narrowed their focus to applying it to a single application: vascular access. They have     demonstrated clinically that the SF can be used successfully to guide the placement of the     peripherally inserted central catheter (PICC) lines. The research proposed here will expand     this application to include the insertion of other central venous access (CVA) lines through     the internal jugular vein, subclavian vein, and femoral vein. The historical approach to CVA     line placements has involved the physical exam and identification of visible landmarks. With     the introduction and common usage of ultrasound, it has become routine to use ultrasound     guidance.      Much of the difficulty in learning conventional ultrasound (CUS) guided procedures stems from     the displaced sense of hand-eye coordination that occurs when the operator looks away from     the operating field to see the ultrasound display. The SF directly addresses many of these     issues and therefore the investigators believe that it is well suited for this application.     They have already shown that novice US users learn vascular access procedures in training     phantoms more quickly using the SF than CUS. They have also shown that intravenous (IV) team     nurses already proficient in CUS guided PICC lines perform vascular access in training     phantoms more quickly using the SF than CUS guidance. Finally, as mentioned earlier, the     investigators have shown that the SF can be used successfully to guide the placement of PICC     lines. This study will test the hypothesis that the SF will successfully facilitate catheter     placement in the subclavian, femoral, and internal jugular veins demonstrating equal     vasculature visualization as conventional ultrasound.   "
189560|NCT00330603|"     This study will seek to determine the amount of acids a person with a chronic cough that is     suspected to be related to acid reflux breathes out after coughing. The study will also seek     to determine if this measurement can predict the best treatment for the cough.      Subjects with a chronic cough which is suspected to be related to acid reflux for which their     doctor has prescribed a proton pump inhibitor medication will be enrolled in this study.   "
189561|NCT00330616|"     This is a study to obtain clinical experience of 323U66 SR for elderly patients with     depression in repeat-dose of 323U66 SR up to 300mg/day, and to conduct exploratory     investigation on safety, efficacy and pharmacokinetics profile in elderly patients with     depression.   "
189562|NCT00330629|"     We propose to add a treatment preference component to a larger study testing standard     behavioral treatment (SBT) for weight loss without specific food group restriction vs     standard behavioral treatment with gradual elimination of meat, poultry, and fish [a     lacto-ovo-vegetarian (LOV) meal plan]. Eligible respondents will be randomized to one of two     conditions: Treatment Preference-Yes/No. Individuals in the Treatment Preference-Yes will be     assigned to their choice (SBT or SBT+LOV), those in Treatment Preference-No will be     randomized to either SBT or SBT+LOV without regard to their preference.   "
189563|NCT00330642|"     The purpose of this study is to determine whether a rapid bedside diagnosis of group B strep     (GBS) growing in the vagina and rectum can be performed with similar success to the routine     culture in women who are in labor.   "
189564|NCT00330655|"     We hypothesize that memantine may be a safe and effective treatment for moderate to severe     binge eating disorder associated with obesity.      During this 12-week, open-label, outpatient study, male and female subjects between the ages     of 18 and 65 years who have moderate to severe binge eating disorder and are obese will be     treated with open-label memantine. Following this 12-week treatment phase, subjects may be     eligible to continue into an extension phase which will last an additional 12 weeks. During     the extension phase subjects will continue open-label memantine treatment.   "
189565|NCT00330668|"     This is an extension study to Tercica study MS301 (NCT00125164) and is intended to collect     long term safety and efficacy data on the continued use of recombinant human insulin-like     growth factor-1 (rh IGF-1) in children and adolescents treated for primary IGF-1 deficiency     (IGFD). The secondary objective is to use the data collected to learn more about the     relationship of IGF-1 exposure to the promotion of normal growth and pubertal development.   "
189566|NCT00330681|"     The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via     intravenous drip once a day in patients with ALS based on the changes in the revised ALS     functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind,     placebo-controlled manner. And in addition, this study will be performed to examine the     safety of MCI-186 to ALS patients.   "
189576|NCT00330811|"     B-type Natriuretic Peptide (BNP) is a hormone that is made by the pumping chambers of the     heart. The BNP level can be measured by a blood test and is used as a marker for heart     problems in adults. Deciding if a child has a heart problem or a lung problem can be very     difficult, especially in infants. Several studies have demonstrated that BNP levels are     elevated when children have heart disease.      The overall goal of the study is to be able to prove that obtaining BNP levels in pediatric     patients can be used to identify heart problems. We already know that kids with heart     problems have high BNP levels (>200pg/ml). We need to prove that children who come to the     Emergency Department for non-cardiac problems still have normal BNP levels (<100pg/ml,     slightly higher in the newborn population). This will be done by comparing BNP levels with     the final diagnosis made by the ED physician.   "
189578|NCT00330837|"     Inadvertent puncture of an unintended object in a vascular access procedure is common and can     lead to serious consequences. Inadvertent common carotid artery (CCA) puncture while     targeting the internal jugular vein (IJV), for example, is reported to have an incidence of     2% - 8% and usually results in localized hematoma formation. The hematoma may enlarge rapidly     if the patient is coagulopathic, or if a large puncture wound is produced by the introduction     of the sheath itself into the CCA. Airway obstruction, pseudoaneurysm, arterio-venous fistula     formation and retrograde aortic dissection have all been reported as a consequence of CCA     puncture. In the presence of occlusive (atheromatous) carotid disease, inadvertent puncture     may carry the risk of precipitating a cerebrovascular accident.      In this study, we aim to collect color Doppler and B-mode ultrasound videos from the most     common ultrasound-guided vascular access sites - internal jugular vein, subclavian vein,     femoral vein, basilic vein, and brachial vein. The videos will also include structures in     close proximity to the intended veins. Using such database, we will run various vessel     tracking and identification algorithms to evaluate their performance. Our ultimate goal is to     develop an algorithm that will aid the ultrasound operator in identifying structures and     differentiating between arteries and veins.   "
189567|NCT00330694|"     In the course of their disease, most patients with Parkinson's Disease (PD) face mounting     mobility deficits, including difficulties with walking, balance, posture and transfers. This     frequently leads to (fear of) falls, injuries, loss of independence, and inactivity which     causes social isolation and increases the risk of osteoporosis or cardiovascular disease.     These mobility deficits are difficult to treat with drugs and neurosurgery. However,     physiotherapy is deemed effective in improving mobility deficits in PD. Physiotherapy is     widely prescribed for this purpose in the Netherlands. Yet, the efficiency of current usual     care physiotherapy can be questioned, for two reasons. First, the referral process seems     inadequate because patients are mainly referred by neurologists who often lack insight into     the (im-)possibilities of physiotherapy for PD. Consequently, patients with a real need for     physiotherapy are not always referred (undertreatment), whereas others without a real need     are (overtreatment). Furthermore, most therapists treating PD patients are not specifically     trained in treating these patients. This is not surprising because average therapists rarely     treat more than two patients per year in their practice. Therefore, patients who are being     referred probably receive suboptimal treatment.      The objective of this study is to evaluate whether the efficiency of physiotherapeutic care     for patients with Parkinson's disease can be improved, at a reduced cost, by targeting two     key elements of the current care system: a) inadequate referral by neurologists; b)     suboptimal treatment by physiotherapists. We expect that optimal referral combined with     expert treatment will increase the efficiency, as reflected by increased health benefits for     patients at equal or reduced costs'.   "
189568|NCT00330707|"     To compare the toxicity and efficacy of the combination of BCG and interferon alpha to     standard dose and low dose BCG alone in high risk superficial bladder cancer   "
189569|NCT00330720|"     What to do after an elderly patient falls but is not seriously injured can be a very     challenging decisions for the patient and the Emergency Physician. Unfortunately, homecare     support is often unavailable for weeks. The patient and physician must then choose between     discharge home without support, or hospitalization. An emergency response service (ERS)     allows the patient to summon assistance from anywhere in their home, and may provide another     option.      Objectives: To see how an ERS affects patients’ anxiety, fear of falling, and use of the     health-care system after discharge. We will study patients over 70 years of age who have     fallen but do not need to be hospitalized. Our belief is that the ERS will improve patient     anxiety, and may prevent return visits to the Emergency or episodes of prolonged     immobilization after a fall.      Methods: Patients agreeing to participate in the study will be assigned by chance to receive     either current standard discharge care, or standard care plus the use of the emergency     response system. Patients will be interviewed one month after discharge to compare the impact     of the ERS. This study is a first step in deciding whether the ERS is a useful new     technology.   "
189570|NCT00330733|"     The hypothesis is that salsalate therapy may be an effective and safe method to modulate     inflammation in metabolically-critical tissues and thus reduce insulin resistance and its     related complications.      The objectives of the study are to (1) determine whether salsalate therapy improves insulin     resistance in subjects with IGT and changes in glucose area under the curve following a     standard oral glucose tolerance test (OGTT); (2) determine whether salsalate therapy reduces     a) plasma levels of a variety of well established inflammatory proteins and b) mononuclear     cell inflammatory activity to provide evidence of reduced systemic and tissue inflammation,     respectively; and (3)also determine whether salsalate therapy improves parameters of     cardiovascular disease risk, including features of metabolic syndrome (fasting glucose,     triglycerides, HDL, and blood pressure) as well as endothelial dysfunction.   "
189571|NCT00330746|"     The purpose of this study is to select the more promising method of combining cetuximab with     gemcitabine for treating patients with advanced non small-cell lung cancer, who are not     candidates for platinum based therapy.   "
189572|NCT00330759|"     The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid     (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in     subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)   "
189573|NCT00330772|"     Main Research Question(s):      What is the effect of continuing aspirin until the time of coronary artery bypass graft     surgery and of adding clopidogrel to aspirin after coronary artery bypass graft surgery for     preventing blockage of coronary grafts, heart attack, stroke, and death? To reliably answer     this question requires a large randomised trial. Before applying for a major grant from the     Canadian Institute for Health Research to do the large study we would like to perform a small     pilot study of 150 patients to demonstrate that it is feasible to recruit patients and to use     a new test called CT angiography to determine whether the bypass grafts are still working     or have become blocked.      (ii) Why is this research important? Coronary artery bypass surgery has made a very important     contribution to improving the health and survival of patients with advanced coronary artery     disease but still has many problems. One in 10 patients experiences a heart attack at the     time of surgery, 1 in 20 experiences a heart attack, stroke, or death during hospitalization,     and 1 in 4 patients has at least 1 blocked graft within 1 year of surgery. Antiplatelet drugs     such as aspirin and clopidogrel are effective for preventing heart attacks, strokes and     deaths but aspirin is usually stopped before coronary artery bypass graft surgery because of     concerns about increasing the risk of bleeding. The effectiveness of the combination of     clopidogrel and aspirin after surgery has not been evaluated. Our pilot study will provide     key information about feasibility that will help us to design and perform a large definitive     study in the future.      (iii) What is being studied? We will be looking at blood flow in bypass grafts as well as the     occurrence of heart attack, stroke, and death. For safety we will be looking at bleeding,     transfusion, and need for further surgery because of bleeding. We will also perform     laboratory tests of platelet function to measure and compare the effect of the study     treatments to prevent blood clots from forming.   "
189574|NCT00330785|"     To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage     of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their     governing guidelines.   "
189575|NCT00330798|"     The purpose of this study is to compare healing times and subjective pain level responses of     nepafenac to placebo after photo refractive keratomileusis (PRK) surgery.   "
189577|NCT00330824|"     Efficacy/Safety of antibiotic steroid combination compared with individual administration in     inflammation Post-LASIK   "
189657|NCT00331981|"     Primary purpose:        -  To find out how effective is long term treatment with amisulpride on the positive and          negative symptoms in schizophrenic patients        -  To find out how safe is long term treatment with amisulpride in schizophrenic patients      Secondary purpose:        -  To find out how effective is long term treatment with amisulpride on the quality of life          in schizophrenic patients        -  To find out how effective is long term treatment with amisulpride on the cognitive          function in schizophrenic patients   "
189583|NCT00330902|"     In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose     parasitaemia persists at very low levels throughout the dry season, could be a useful     strategy for malaria control in areas with a short transmission season. We did a randomized     trial to compare two regimens for clearance of low level parasitaemia in the dry season.   "
189584|NCT00330915|"     The purpose of this study is to help answer the following research questions:      If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological     parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed;     To evaluate adverse events   "
189585|NCT00330928|"     The purpose of this study is to evaluate a near-infrared (NIR) spectroscopy system that has     been designed to identify the chemical composition of coronary artery plaques in patients     undergoing a percutaneous coronary intervention (PCI).   "
189586|NCT00330941|"     Background: Intravenous infusion of lidocaine may decrease postoperative pain and speed     return of bowel function. The investigators therefore tested the hypothesis that including     perioperative lidocaine infusion improves recovery from laparoscopic colectomy and shortens     the duration of hospitalization.      Methods: Forty patients scheduled for laparoscopic colectomy were randomly allocated to     receive intravenous lidocaine (bolus injection of 1.5 mg.kg-1 lidocaine at induction of     anesthesia, then a continuous infusion of 2 mg.kg-1.h-1 intraoperatively and 1.33 mg.kg-1.h-1     for 24 h postoperatively) or an equal volume of saline. All patients received similar     intensive postoperative rehabilitation. Postoperative pain scores, opioid consumption, and     fatigue scores were measured. Times to first flatus, defecation, and hospital discharge were     recorded. Postoperative endocrine (cortisol and catecholamines) and metabolic (leucocytes,     C-reactive protein, and glucose) responses were measured for 48 h. Data (median [25%-75%     interquartile range] Saline vs Lidocaine groups) were analyzed using Mann-Whitney tests.     P<0.05 was considered statistically significant.   "
189587|NCT00330954|"     One of the goals of the Kansas City Diabetes Consortium is to identify and characterize genes     and their products that are associated with T1DM. Characterization of such genes and their     products can aid in developing new tools for risk assessment, development of new prevention     strategies and monitoring progression of disease.      Study design: Descriptive, basic science pilot study. The results of this pilot study will be     used to help design a much larger study to address the importance of viral response and     autoimmune diabetes.   "
189588|NCT00330967|"     The Objectives of the study are to: (1)compare the inflammatory response and insulin     resistance in skeletal muscles during a systemic infusion of lipid with that during a local     infusion of lipid into the femoral artery. which would cause minimal or no systemic     hyperlipidemia but local plasma free fatty acid (FFA) concentrations similar to those during     the systemic lipid infusion, and (2) determine the inflammatory response and insulin     resistance in skeletal muscle during an infusion of lipid into the femoral artery as     described above after NF-KB inhibition by high dose salicylate treatment in humans.   "
189589|NCT00330980|"     Statins are cholesterol-lowering medications that are often prescribed for individuals with     high cholesterol and who are at risk for heart disease. Preliminary research has shown that     statins may have other effects on the body that are unrelated to the heart. The purpose of     this study is to evaluate the impact of statins on mood, mental processes, aggression, and     serotonin levels.   "
189625|NCT00331500|"     The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in     the treatment of the signs and symptoms associated with allergic conjunctivitis or     rhinoconjunctivitis.   "
189626|NCT00331513|"     This randomized phase I trial is studying the side effects and best dose of vorinostat when     given together with idarubicin in treating patients with relapsed or refractory leukemia or     myelodysplastic syndromes. Drugs used in chemotherapy, such as vorinostat and idarubicin,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Vorinostat may also stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Giving vorinostat together with idarubicin may     kill more cancer cells.   "
189731|NCT00333008|"     The purpose of this study is to evaluate the feasibility and tolerability of delivering a     full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine,     prednisone, and rituximab) in NHL.   "
189590|NCT00330993|"     HYPOTHESIS: For women with pregnancies at <49, 50-56, and 57-63 days gestation who receive     mifepristone 200 mg orally and misoprostol 800 mcg buccally at the same time, the complete     abortion rate 24 hours after misoprostol administration will be 90% (95% CI 78%, 97%) within     each gestational age group.      This is a prospective clinical trial. Women will be enrolled such that 40 women are in each     of three gestational age ranges: ≤49, 50-56, and 57-63 days gestation on the day treatment is     initiated. Once a gestational age range includes 40 subjects, enrollment in that group will     be closed. Subjects will swallow mifepristone 200 mg and then place four 200 µg misoprostol     tablets between the check and gum (2 tablets on each side). The women will be instructed to     keep the tablets in place for 30 minutes; any remaining portions of the tablets will be     swallowed after this time. Participants will follow-up 24 hours after receiving the     misoprostol. Vaginal ultrasonography will be performed to assess for expulsion of the     gestational sac. Women who have not aborted by the first follow-up visit will be given a dose     of vaginal misoprostol and will return for a follow-up visit in one week. Subjects who have     not aborted by the two-week follow-up will be offered a surgical abortion. At each visit,     data will be collected on bleeding, cramping, other side effects, and medication use.   "
189591|NCT00331006|"     Hemophilia A is a serious blood clotting disorder caused by a lack of factor VIII, a     specialized protein needed for normal blood clotting to occur. Individuals with this disease     may experience spontaneous bleeding, pain and swelling in their joints due to excess     bleeding, and bruising. A common treatment for severe hemophilia A is to intravenously     replace the deficient blood clotting factor; however, some individuals may develop antibodies     to this replacement factor. This study will evaluate the effectiveness of rituximab at     reducing the antibodies that develop in response to the replacement factor in individuals     with severe hemophilia A.   "
189592|NCT00331019|"     The purpose of this study is to determine whether a rapid bedside diagnosis of Group B Strep     growing in the vagina and rectum can be performed with similar success to the routine     culture.   "
189593|NCT00331032|"     The purpose of this study is to test the safety and tolerability of a medication applied     vaginally twice daily in females versus placebo (inactive substance). Study participants will     include 60 women, ages 18-24, non-pregnant, previously sexually active, Human     Immunodeficiency Virus (HIV) negative and sexually transmitted infection (STI) free, in San     Francisco or Kisuma, Kenya. Each study participant will be followed for 14 days of product     use and an additional 7 days for safety assessments. Study procedures will include a physical     exam with a pap smear, urine testing, blood sample testing, and a colposcopy (exam of the     vagina and cervix using a lighted magnifying instrument). Information learned from this study     may help to develop a safe and effective medication that could prevent herpes simplex virus     and HIV. Participants may be involved in study related procedures for up to 55 days.   "
189594|NCT00331045|"     This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day     (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in     patients who receive opioids for the management of cancer pain and develop constipation, by     giving overall consideration to the efficacy and safety data in each treatment group. Also,     efficacy and safety data of alvimopan in the recommended dose group will be compared with     those of placebo and to confirm alvimopan's safety and efficacy.   "
189595|NCT00331058|"     The primary goal of this study is to compare the expression of key GSK drug targets across     the 4 asthma phenotypes and healthy subjects and secondarily to evaluate changes in target     expression in response to a 2-week course of corticosteroids across the 4 asthma phenotypes.     Each asthmatic subject in this study will undergo two bronchoscopies. Each healthy subject     will undergo one bronchoscopy.   "
189596|NCT00331071|"     The purpose of the study is to assess the occurrence of venous thromboembolism (blood clots),     stroke, and heart attack in current users of ORTHO EVRA compared to current users of     norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol with special     attention to duration of use. The study uses data from the PharMetrics Patient-Centric     Database and MarketScan database, which are US medical claims databases.   "
189597|NCT00331084|"     efficacy of antibiotic steroid combination compared with individual administration in     prevention of postoperative inflammation in patients having cataract surgery   "
189598|NCT00331097|"     The purpose of this study is to compare disease free survival of elderly breast cancer     patients treated with standard adjuvant chemotherapy (CMF) versus experimental adjuvant     chemotherapy (weekly docetaxel).   "
189599|NCT00331110|"     The goal of this project is to assess the effects of an ankle strap on the effectiveness of a     laterally-wedged insole with ankle strapping in reducing knee symptoms and improving static     and dynamic lower limb biomechanics. Using a repeated measures, modified cross-over design,     the following aims and hypotheses will be addressed:      Biomechanical Hypotheses        1. Use of the insole with ankle strapping significantly alters hip-knee-ankle (HKA) angle          towards 180° or talar valgus angulation.        2. Use of the insole with ankle strapping significantly reduces peak knee external varus          moment during gait.        3. Use of the insole with ankle strapping significantly reduces foot external rotation          (out-toeing) or widened base during gait analysis.        4. The radiographic HKA angle and tilt angle of the talus will predict knee peak external          varus moment during gait.      Clinical Hypotheses      1. The use of an insole with ankle strapping over a two-week period will reduce knee pain     (Visual analogue scale, and Knee Osteoarthritis Outcome Survey).   "
189600|NCT00331123|"     This study is designed to evaluate efficacy and safety of a testosterone patch as treatment     for low libido in surgically menopausal women who are taking estrogen therapy.   "
189601|NCT00331136|"     The purpose of this study is to evaluate three dose levels of a combination of pyronaridine     and artesunate for the treatment of uncomplicated falciparum malaria in children.   "
189602|NCT00331149|"     This study was designed to compare the effectiveness and tolerability of a new prolonged     release formulation of ropinirole with the currently marketed immediate release formulation     which is prescribed in many countries. The new prolonged release formulation allows the drug     to be taken once a day rather than three times a day. This study will also evaluate the side     effects of the new prolonged release formulation of ropinirole   "
189732|NCT00333021|"     This study is phase 3 study for prevention of VTE in patients with abdominal surgery.   "
189604|NCT00331175|"     The purpose of this trial is to evaluate the safety and tolerability of single escalating     doses of Peptide YY3-36 and to determine effects on food intake and serum hormones when     administered by intravenous infusion to otherwise healthy overweight adult subjects.   "
189605|NCT00331188|"     The main objective of this study is to determine the efficacy of early administration of     Sanvar® in combination with endoscopic treatment for the control of acute variceal bleeding.   "
189606|NCT00331201|"     Feeding intolerance is a common problem in the NICU. Feeding intolerance complicates the     hospitalization, lengthens the hospital stay, and adds substantially to the cost of care. We     developed a method aimed at treating intestinal villous atrophy. We accomplished preclinical     testing of the product, and four Phase I clinical trials, including two at McKay-Dee Hospital     in 2004. Our preparation is a sterile, isotonic, solution that simulates human amniotic fluid     in electrolyte composition, albumin concentration, and two enterocyte growth factors that are     present in human amniotic fluid; erythropoietin and granulocyte colony-stimulating factor. We     termed the product SAFEstart, using the acronym Simulated Amniotic Fluid for Enteral     administration. This trial on the efficacy and safety of SAFEstart administration as a     treatment for neonates who have feeding intolerance.      Hypothesis is that infants with feeding intolerance, randomized to the SAFEstart will have a     greater enteral calories per kilogram per day for the seven days following conclusion of the     SAFEstart administration.   "
189607|NCT00331214|"     This study is designed to evaluate efficacy and safety of a testosterone patch as treatment     for low libido in surgically menopausal women who are taking estrogen therapy.   "
189619|NCT00331409|"     RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Everolimus may also block blood flow to the     tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib     mesylate works in treating patients with metastatic or unresectable kidney cancer.   "
189608|NCT00331227|"     Flavonoids are one of the many classes of natural chemicals found in a variety of foods.     People with the highest flavonoid blood levels have the lowest rates of coronary heart     disease. This is considered one of the reasons why high fruit and vegetable consumption is     associated with lower rates of heart disease, although it is not known if taking a flavonoid     supplement provides the same protection as eating fruits and vegetables.      The purpose of this study is to determine if a particular flavonoid supplement, called     Isotonix OPC-3, taken on a daily basis, will improve the function of arterial vessels.     Arteries normally constrict after eating a high-fat meal. This study will examine the     potential of the OPC-3 to lessen this constriction response. Approximately 25 people will be     involved in this research project and participation will last for 10 weeks.   "
189609|NCT00331240|"     The purpose of this study is to compare the short-term (8 week) mean 24-hour intraocular     pressure control and safety of TravTim fixed combination given once in the evening with     placebo once in the morning versus TravTim given once in the morning with placebo once in the     evening in patients with open-angle glaucoma.   "
189610|NCT00331253|"     To establish the safety and efficacy of indocyanine green-mediated photothrombosis (i-MP) for     the treatment of patients with neovascular age-related macular degeneration.   "
189611|NCT00331279|"     The purpose of this study is to determine whether oral cinnamon extract are effective in     reducing insulin resistance parameters in women with polycystic ovary syndrome.   "
189612|NCT00331292|"     The primary goal of this study is to identify a gene or panel of genes which are     differentially expressed in lung cells and tissue from asthmatic patients following     administration of Ipratropium bromide and eiTher nebulised Albuterol or saline. Each subject     in this study will undergo two bronchoscopies.   "
189613|NCT00331305|"     This study will evaluate the effectiveness of both center-based and home-based exercise     versus the antidepressant drug sertraline in treating depression in middle-aged and older     adults.   "
189614|NCT00331318|"     This study will determine if applying electrical stimulation of the brain can influence     training to perform finger movements. The study may provide information that can be used to     design rehabilitation therapies for people who have lost the ability to move a part of their     body, such as an arm, leg, or hand following a stroke.      Healthy volunteers 18-50 years of age may be eligible for this study. Candidates are screened     with a medical history, physical examination, MRI (if one has not been done within the last     year), questionnaire to evaluate memory and attention and a pregnancy test for women who can     become pregnant.      Participants have the following tests and procedures in seven sessions over about 8 weeks:        -  Questionnaires to test attention, fatigue and mood before, during and after each session        -  Surface electromyography: Electrodes are filed with a conductive gel and taped to the          skin over one small hand muscle to measure the electrical activity of muscles.        -  Transcranial magnetic stimulation: A wire coil is held on the scalp. A brief electrical          current passes through the coil to stimulate the brain. During the stimulation, the          subject may be asked to tense certain muscles slightly or perform other simple actions.          The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject          may hear a click and feel a pulling sensation on the skin under the coil.        -  Transcranial direct stimulation (tDCS) before and during motor training: Small, wet          sponge electrodes are applied to the head - one above the eye and the other on the back          of the head. A small electrical current is passed between them. The subject may feel an          itching or tingling sensation under the electrodes or see light flashes.        -  Motor learning under tDCS: tDCS is repeated while the subject performs the training          task. The training task consists of performing voluntary brisk thumb movements in a          direction opposite to TMS-induced movement directions, during 30 minutes. Training          blocks are in 10-minute segments and tDCS is applied during the first 20 minutes.        -  Behavioral measurements: Evaluation of learned movement tasks.   "
189615|NCT00331331|"     This study will examine the proteins of people with uveitis, or inflammation of the eyes.     Evaluating the vitreous, the colorless transparent substance that fills the eyeball in back     of the lens, is now possible with the use of new microtechnology. There is an opportunity to     evaluate the kinds of proteins that are present in severe, noninfectious sight-threatening     uveitis.      Patients ages 18 and older who have been enrolled in the Multicenter Uveitis Steroid     Treatment (MUST) study at NIH may be eligible for this study. Up to 200 patients eventually     may be enrolled. Researchers will study the vitreous that will be removed from patients' eyes     during an operation to insert a steroid implant. The steroid implant is used instead of     immunosuppressive therapy, a way to reduce the action of the immune system.      Patients will undergo a procedure involving a small hole made in the eye into which the     implant is placed. Normally a small amount of the vitreous comes out during that procedure,     and in this study, the vitreous specimen will be taken for testing of inflammatory products.     At the same time, a small sample of blood, about 1-1/2 tablespoons, will be collected so that     the researchers can compare inflammatory products that may be in the blood with those in the     vitreous. If a patient needs to have the implant placed again during the study, he or she     would be asked permission for collection of the vitreous and blood samples, as previously.     Samples collected will not be used to diagnose patients' conditions or to change any     treatments being done. All samples will be labeled with special code numbers so that there is     no identifying information about patients. This study will not involve examinations or     scheduled visits of patients.   "
189616|NCT00331344|"     This phase I/II trial is studying the side effects and best dose of ixabepilone and     mitoxantrone hydrochloride when given together with prednisone and to see how well they work     in treating patients with metastatic prostate cancer that did not respond to hormone therapy     and chemotherapy. Drugs used in chemotherapy, such as ixabepilone, mitoxantrone     hydrochloride, and prednisone, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) may kill more tumor cells   "
189617|NCT00331357|"     The objective of this study is to describe a paediatric population presenting an acute     idiopathic thrombocytopenic purpura (ITP) and their evolution during their therapy in the     region Pays de la Loire. The study will particularly evaluate the quality of life of these     patients and their parents.      The secondary objectives are to identify the predictive factors of the complications, the     repetitions and the chronicity of the ITP, to estimate the principal parameters of the     economic cost of therapy of the children suffering from ITP according to the protocol of     therapy, set up in the region Pays de la Loire and the constitution of a blood sample     collection which allow a better understanding of the physiopathology of this disease.      It is about a prospective, multicentric clinical epidemiologic study of a paediatric cohort.     Patients: 100 children from 0 to 17,99 years suffering from a first discovered ITP. The     patients are not included if they present a serious, intercurrent, stabilized chronic     pathology or not likely to modify the quality of life of the child and if they present a     pathology other than the thrombopenia bringing into play the vital prognosis within a time     lower than one year. These patients will be followed for 6 months according to the diagnosis     of their ITP.      During the 6 months follow-up of each patient, the study will not carry out more     consultations, nor more blood tests than the usual follow-up of a child suffering from ITP.     On the other hand, in addition to the J0 questionnaire, it will be requested to the patient     and to his family to fill in the questionnaires of quality of life and way of life during the     consultations of J8, 1 month, 3 months and 6 months. A check-up of autoimmunity at 6 months     will be carried out if the thrombopenia persists (this check-up is usual and not-specific to     the study). At the time of the blood test for the control of the platelets at J0 and 6     months, an additional blood sample will be carried out: 5 ml are taken for the children of an     age ≤ at 2 years, 10 ml from 2 to 4 years and 15 ml of blood for the children of an age > at     4 years. These blood samples are intended for the constitution of a blood sample collection.      The protocol of therapy of the children suffering from ITP is homogeneous in all centers,     this protocol being a consensus established by the network of Oncopaediatrics of the Pays de     la Loire. The instituted treatment will be in function of the gravity of the ITP expressed in     4 stages:      Stage I: Platelets > 20 gigas/L and absence of clinical signs. Stage II: Platelets > 10     gigas/L and hemorrhagic signs: haematomas, petechias or occasional epistaxis without     repercussion on the daily life.      Stage III: moderate. Platelets > 10.000/mm3 and epistaxis with gauze pluggings or mucous     lesions.      Stage IV: severe. Platelets ≤ 10.000/mm3 or fall of 2 grs/dl of haemoglobin with bleedings:     epistaxis, melaena or haemorrhages requiring a blood transfusion or an hospitalization and     important changes in the activities of the daily life.      Stages I and II do not receive any treatment and benefit from a simple monitoring.      Stages III benefit from either a corticosteroid treatment (Méthylprednisolone or Prednisone)     at the dose of 4 mg/kg and per day in 2 intervals during 4 days (maximal dose of 100 mg/day)     or a monitoring according to the appreciation of the clinician.      Stages IV profit in first intention from a treatment by Méthylprednisolone or Prednisone at     the dose of 4 mg/kg and per day in 2 intervals during 4 days (maximal dose of 100 mg/jour).      The therapeutic attitude and the stadification belong to a regional consensus, established     before the study, but each one can decide to apply a treatment according to the gravity of     the clinical state of the child.   "
189618|NCT00331370|"     Damage to very small blood vessels is a consequence, but can also precede high blood     pressure. Such damage, measured by disturbances in the vessels in the retina (back of the     eye) is a strong predictor of heart disease and stroke. South Asian people have one of the     highest rates of hypertension in the world (30% in adults). In Pakistan, this is usually     severe, undetected and untreated. The Wellcome Trust has already funded a study of blood     pressure control in adults and children in this population. We propose a substudy, taking     photographs of the retina and making measurements of the vessels, to determine whether such     blood pressure related changes occur at an early age in young children with a family history     of high blood pressure compared to those without, whether such changes predict an increase in     blood pressure over time, and whether, in adults, such changes can be reversed by blood     pressure treatment. The hypothesis of our study is: young offspring of South Asian people     with hypertension have a disturbed microcirculation, as assessed by abnormalities of retinal     vessels, compared to offspring of normotensive parents. Our 2nd hypothesis is: Abnormal     retinal vascular geometry will improve proportionately to achieved reductions in BP.   "
189620|NCT00331422|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or stopping them from     dividing. Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin     before surgery works in treating patients with advanced ovarian epithelial cancer, fallopian     tube cancer, or primary peritoneal cavity cancer.   "
189621|NCT00331435|"     The purpose of this study is to evaluate and conduct an exploratory comparison of the     efficacy and safety of indocyanine green angiography (ICGA) guided photodynamic therapy (PDT)     and fluorescein angiography (FA) guided PDT for exudative age-related macular degeneration     (AMD) accompanied with polypoidal choroidal vasculopathy (PCV).   "
189622|NCT00331448|"     The purpose of this study is to collect data on the body's breakdown of sugar and fat in HIV     infected adults. Data from this study will make clearer the roles of HIV infection and     anti-HIV drugs in the development of diabetes, heart disease, and fat redistribution in HIV     infected adults.   "
189623|NCT00331474|"     Background:      Each year, more than half a million babies are infected with HIV by mother-to child     transmission in developing countries. Many of these babies get sick and develop HIV disease     (AIDS) at a very young age. Exposure to other infectious diseases may influence this early     progression to AIDS. BCG is a live tuberculosis vaccine made from cow tuberculosis. It is     routinely given at birth to most babies, also to babies born to HIV-positive mothers. BCG can     cause disease (BCGosis) in HIV-infected babies. More importantly, BCG may also trigger immune     responses in the body that lead to the spread of the HIV virus and early progression to AIDS.      Objective(s) and Hypothesis:      The researchers will investigate whether BCG causes progression of HIV by doing a clinical     trial: babies born to HIV-positive mothers will be randomly allocated to get the BCG vaccine     at birth or at 14 weeks of age. In these 2 groups of babies, the researchers will compare:        -  The percentage of babies who progress to HIV disease        -  Blood markers of HIV disease (the amount of virus and protective white blood cells in          the body)        -  The body's immune response to BCG vaccine and other childhood vaccines        -  The percentage of children who develop BCG scarring, BCG vaccine complications and          tuberculosis.      Potential Impact:      BCG is the most widely given vaccine worldwide and is routinely given to babies born to     HIV-positive mothers in developing countries. Any effect that BCG has on HIV progression in     babies will have a significant public health impact in settings with a high burden of HIV     disease.   "
189624|NCT00331487|"     Efficacy comparison of Pioglitazone, once daily (QD), to Rosiglitazone in participants with     Type 2 Diabetes   "
189628|NCT00331539|"     Cochlear implants require programming on an individual basis to provide appropriate levels of     electrical stimulation. This program, or map, is placed in the speech processor of the     cochlear implant. Success of implantation largely depends on the adequacy of this map.     Cochlear implant fitting remains a difficult challenge in congenitally or pre-linguistically     deafened children. It requires competence of experienced audiologists with expertise in     behavioral techniques for hearing function assessment.Our goal is to establish the offset     correlation between objective measurements (NRT and ESRT) and the behavioral measurements of     T & Cs in different stimulation rates in the Freedom SP System.   "
189629|NCT00331552|"     Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and cyclophosphamide,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Giving more     than one drug (combination chemotherapy) together with trastuzumab may be a better way to     block tumor growth.   "
189630|NCT00331565|"     Altered bioavailability of drugs will potentially affect both drug efficacy as well as     safety. In patients subjected to bariatric surgery due to morbid obesity the gastro     intestinal tract is considerably reconstructed and a change in drug bioavailability is very     likely. Getting further knowledge on important mechanisms responsible for altered     bioavailability would help in predicting clinically relevant consequences on different drugs.      In the present study we aim to investigate the effect of bariatric surgery on atorvastatin     bioavailability. Atorvastatin is subjected to both extensive metabolism and drug transport     and will potentially be a good predictor for mechanisms relevant for other drugs as well.      In addition will the expression of different enzymes and transporters be measured in the     gastrointestinal tract and in the liver to elucidate on mechanism behind the eventual     effects.   "
189631|NCT00331578|"     The trial aims to evaluate 12-month long-term efficiency of Excel stent in the treatment of     coronary heart disease and inhibition of restenosis after coronary artery stenting as well as     a 12 months' long-term safety after the cessation of clopidogrel as an anti-platelet drugs     used for 6 months after the implantation of degradable drug coating stent.   "
189632|NCT00331604|"     This trial is conducted in Asia, Europe and South America. The aim of this research is to     compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary     function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart     both in combination with insulin detemir in Type 2 Diabetes.   "
189633|NCT00331630|"     RATIONALE: Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their     growth. Giving Abraxane together with lapatinib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving Abraxane together with lapatinib     works in treating patients with stage I, stage II, or stage III breast cancer.   "
189634|NCT00331643|"     This phase II trial is studying how well ixabepilone works in treating young patients with     refractory solid tumors. Drugs used in chemotherapy, such as ixabepilone, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.   "
189649|NCT00331851|"     This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to     show the effect of treatment with liraglutide added to existing glimepiride and metformin     combination therapy and to compare it with the effects of insulin glargine added to     combination therapy of glimepiride and metformin.   "
189635|NCT00331656|"     Non-invasive ventilation has become increasingly important in the management of patients with     acute respiratory failure. One of its major goals is to prevent the need for invasive     ventilation, which is associated with numerous complications. This study compares the     usefulness and safety of two noninvasive techniques which are used in Medical practice:     Noninvasive positive pressure ventilation using a face mask and extrathoracic biphasic     ventilation using a cuirass. Each of these techniques has advantages and disadvantages and     both may not suit all patients. It is therefore important to compare the two in terms of     effectiveness in preventing invasive ventilation and their side effects profile, so that we     can improve our understanding and expertise in the treatment of patients in respiratory     failure.   "
189636|NCT00331669|"     The purpose of this randomized, double blind, multi-center study is to assess the efficacy     and safety of bilateral pallidal deep brain stimulation in patients with tardive dystonia.   "
189637|NCT00331682|"     Drugs used in chemotherapy, such as docetaxel and flavopiridol, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.     Flavopiridol may also help docetaxel work better by making tumor cells more sensitive to the     drug. This phase II trial is studying how well giving docetaxel followed by flavopiridol     works in treating patients with refractory metastatic pancreatic cancer.   "
189638|NCT00331695|"     To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones     caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by     the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20     and 32 weeks of gestation and:        -  either a first episode of preterm labor stopped by acute tocolysis;        -  either a history of late miscarriage or premature delivery or uterine malformation or          DES        -  either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed          with initial stratification according to these three risk groups, opened with two          parallel arms.   "
189639|NCT00331708|"     The main purpose of this study is to compare the drug levels of artesunate and     sulfadoxine-pyrimethamine found in pregnant women with malaria to those drug levels found in     non-pregnant women from other studies. In addition the efficacy and safety of the study drugs     will be determined for pregnant women and their babies.   "
189640|NCT00331721|"     The main objective of this study is to investigate the tolerability of enecadin in patients     with acute ischemic stroke. Furthermore, the pharmacokinetics of enecadin in both male and     female patients with acute ischemic stroke will be assessed. Efficacy trends will be     evaluated up to day 30 post stroke.   "
189641|NCT00331747|"     Hypothesis: Treatment with Glatiramer acetate prevents deterioration of gait in multiple     sclerosis (MS) patients.      During the study patients will undergo a 3 dimensional gait analysis before starting     treatment with glatiramer acetate and after 1 year of treatment.   "
189642|NCT00331760|"     RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy     (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor     cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with     or without chemotherapy after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to     the pelvis with or without chemotherapy works in treating patients with endometrial cancer or     cervical cancer that has been removed by surgery.   "
189643|NCT00331773|"     RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to     help focus thin beams of radiation directly on the tumor, and giving hypofractionated     radiation therapy (higher doses over a shorter period of time), may be less costly with fewer     side effects and just as effective in treating prostate cancer.      PURPOSE: This randomized phase III trial is studying several different radiation therapy     regimens to compare how well they work in treating patients with stage II prostate cancer.   "
189644|NCT00331786|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of nitric oxide-releasing acetylsalicyclic acid may prevent     colorectal cancer.      PURPOSE: This randomized phase I trial is studying the side effects and best dose of nitric     oxide-releasing acetylsalicyclic acid in preventing colorectal cancer in patients at high     risk of colorectal cancer.   "
189645|NCT00331799|"     The purpose of this study is to explore benefits of duloxetine in enhancing psychological     resilience and to understand the relevance of inhibiting of both serotonin (5HT) and     norepinephrine (NE)to therapeutic responses.   "
189646|NCT00331812|"     In Amyotrophic Lateral Sclerosis (ALS), malnutrition is frequent (16 to 50 % of the patients)     and is an independent prognostic factor. One of the implicated factors is the increase of     resting energy expenditure (REE) which can be found in about 50 % of ALS patients. The origin     of this hypermetabolism is currently unknown but could be located in the mitochondria. In     fact, some studies have found mitochondrial abnormalities and the existence of an oxidative     stress. Thus, the aim of this study is to characterize the mitochondrial abnormalities and     the oxidant/antioxidant status of ALS patients and to determine their relationship with the     metabolic status, hypermetabolism or normometabolism. Three groups of patients will be     studied : 20 hypermetabolic ALS patients, 20 normometabolic ALS patients and 20 healthy     volunteers paired for age and sex.   "
189647|NCT00331825|"     We initiate a study with research grant from department of health and Taoyuan mental hospital     and choose risperidone and olanzapine as study medications. We compare the incidence of using     anticholinergic drugs in schizophrenic patients of Han ethnics with neuroleptic-induced acute     dystonia or parkinsonism to test the hypothesis that these two medications have different EPS     incidence in EPS intolerant population.   "
189648|NCT00331838|"     The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026)     for the prevention of Venous Thromboembolism [VTE] in patients undergoing total knee     replacement [TKR] surgery.      Secondary objectives were to evaluate the safety (incidence of major bleeding) of AVE5026, to     document the efficacy and safety of AVE5026 post-operative regimens, and to assess the     pharmacokinetic parameters of AVE5026.   "
189650|NCT00331864|"     Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human     vascular endothelial growth factor A. This study will assess the safety and efficacy of     ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal     neovascularization (CNV) secondary to age-related macular degeneration (AMD).   "
189651|NCT00331877|"     Decisions to limit life sustaining treatments are made for most patients dying in the ICU,     usually with input from the family. The well-being of the family may be jeopardized by     involvement in the decision-making process and bereavement. We evaluated the ability of a     proactive communication strategy (family conference and providing family members with a     bereavement information leaflet) designed to improve family well-being.   "
189652|NCT00331890|"     Citicoline is a safe drug approved in some countries for the treatment of acute ischemic     stroke. The drug has shown some evidence of efficacy in a pooled analysis, based on four     clinical trials done in USA with oral citicoline.The purpose of the study is confirm the     results obtained in the pooled analysis, that is, evidence of efficacy in the treatment of     acute ischemic stroke   "
189653|NCT00331916|"     The purpose of the study is to determine whether AL-15469A is safe and effective in the     treatment of bacterial conjunctivitis.   "
189654|NCT00331929|"     Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate     the health status of children living in K. Tivon.      The health status will be evaluated using health questionnaires and spirometry.   "
189655|NCT00331942|"     To determine the ability of the Cimmunology process to lead to in vitro antibody production,     the ability of the ELISA assays to detect any of those antibodies, and to establish the     relationship between the ELISA results and the clinical / pathological status of the patient.     The statistical significance of the CAAb test results will be determined.   "
189656|NCT00331955|"     This phase I trial is studying the side effects and best dose of vorinostat when given     together with doxorubicin in treating patients with metastatic or locally advanced solid     tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as doxorubicin, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Vorinostat may help doxorubicin work better by making tumor cells more sensitive to     the drug.   "
189676|NCT00332228|"     The overall goal of this research project is to test the efficacy of a newly developed     therapy, Behavioral Naltrexone Therapy (BNT), to enhance the success of naltrexone     maintenance and long-term abstinence for individuals with heroin dependence. This study     includes free detox and outpatient treatment for opioid dependence that includes medication     and a behavioral intervention.   "
189658|NCT00331994|"     Primary objective: to assess the efficacy of Bacillus clausii versus metronidazole in the     eradication of the small intestinal bacterial overgrowth, 30 days after the end of treatment.      Secondary objective: to assess the efficacy of Bacillus clausii versus metronidazole in     avoiding recurrence of the small intestinal bacterial overgrowth, 90 days after the end of     the treatment; to assess the efficacy of Bacillus clausiiversus metronidazole in improving     irritable bowel syndrome -related symptoms; to assess the efficacy of Bacillus clausii versus     metronidazole in the satisfactory relief of overall irritable bowel syndrome symptoms and of     abdominal discomfort or pain; to assess the efficacy of Bacillus clausii versus metronidazole     in improving irritable bowel syndrome quality of life.   "
189659|NCT00332007|"     Overall trial objectives:        1. Can treatment with tonabersat reduce the number of days with aura and/or migraine          headache in patients with migraine with aura        2. How well tolerated is treatment with tonabersat      The study is based on the hypothesis that the unique mechanism of action of tonabersat will     inhibit some of the early events in the generation of aura and migraine headache and so be     effective as prophylactic treatment   "
189660|NCT00332020|"     The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is     safe and can help prevent blood clots forming after a hip replacement operation.   "
189661|NCT00332033|"     Uterine leiomyomas (fibroids) represent a major public health problem with few effective     therapies. Currently, the only definitive treatment is hysterectomy and women are demanding     alternative therapies to surgery. We have developed a new approach to the treatment of     uterine fibroids based on collaborative laboratory research into the molecular,     ultra-structural, and histopathologic changes that occur with the transformation of normal     uterine myocytes into abnormal myocytes comprising uterine fibroids. We have confirmed that     excessive, dysregulated collagen production (fibrosis) and abnormal collagen deposition is an     underlying etiology in the pathogenesis of leiomyoma. We will test the hypothesis that an     anti-tumor drug (Pirfenidone) will decrease the size of clinically relevant leiomyomas by     30%. The specific aim is to compare the effects of pirfenidone with placebo on uterine     leiomyoma volume. Thirty-two (32) women will be randomized in a double-blinded treatment     design. Inclusion criteria include women that have completed child-bearing, who are     candidates for hysterectomy, are using effective contraceptive, and have at least one uterine     leiomyoma greater than 4 cm diameter confirmed by ultrasound. Women will be excluded if they     have a body mass index greater than 33 kg/m(2), other gynecological diseases, and history of     cardiovascular disease or smoking. Response in each treatment group will be assessed by T-2     weighted magnetic resonance imaging (MRI) and 3-D ultrasound imaging studies during the     enrollment period. To our knowledge, this will be the first study to document the response of     large fibroids to a short-term trial of an anti-tumor drug. The data will be used to further     define the role of fibrosis in leiomyoma and establish other clinical trials to thoroughly     evaluate such therapeutic approaches for uterine leiomyomas.   "
189662|NCT00332046|"     Evidence suggests the use of neuroimaging to detect therapeutic effects of anxiolytic     treatment when appropriate cognitive-emotional tasks are use to activate the emotional brain     neurocircuitry believed to be involved in the core symptoms of the disease.   "
189663|NCT00332059|"     The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed     Combination in patients with glaucoma or ocular hypertension   "
189664|NCT00332072|"     The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed     Combination in the treatment of glaucoma or ocular hypertension   "
189665|NCT00332085|"     This pilot trial seeks to gather preliminary data on the combination of chromium picolinate,     the most commonly used form of chromium, and metformin. The trial will recruit type 2     diabetes subjects already on metformin and treat them with chromium for 8 weeks. The results     of this trial will provide vital preliminary data including safety and size of effect to     direct future studies.   "
189666|NCT00332098|"     This study will evaluate the effectiveness of family-focused treatment (FFT) plus     pharmacotherapy in treating adolescents with bipolar disorder.   "
189667|NCT00332111|"     The proposed protocol aims to characterize the infectious episodes in pancreas transplant     recipients under the current medical care. Knowing these patients infectious risks, the types     of infections that commonly affect them and the morbidity and mortality associated with it     will provide valuable information in the evaluation of the safety and efficacy of the current     practices. The information generated by this study will also serve as the basis for     development of strategies targeting prophylaxis of infectious episodes.   "
189669|NCT00332137|"     The muscarinic antagonist tolterodine is widely used treat urinary urge incontinence. Though     acteylcholine is the primary excitatory neurotransmitter in the gastrointestinal tract, the     phase III trials suggest that tolterodine infrequently causes constipation. Therefore, the     objectives of this study are to assess if tolterodine affects the speed at which food travels     through the stomach, intestines and colon (i.e., gastrointestinal and colonic transit) in     healthy subjects.   "
189670|NCT00332150|"     Parental approval to enroll their sick children in clinical research was studied. However,     the motivation of parents to enroll healthy children and/or babies was not yet studied. The     importance of clinical research among the healthy population is of extreme value. The aim of     this study is to assess the motivation, medical trust and other factors influencing parents'     decision to enroll their healthy baby in a clinical study.   "
189671|NCT00332163|"     A comparison of prophylactic treatment with reactive treatment for skin toxicity observed in     patients with metastatic colorectal cancer (mCRC) who are receiving second-line     irinotecan-based chemotherapy concomitantly with panitumumab.   "
189672|NCT00332176|"     The objective of this study is to undertake an initial evaluation of the safety,     tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with     peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.   "
189673|NCT00332189|"     The objective of this study is to evaluate the safety of long-term treatment with Phenoptin     in subjects with phenylketonuria (PKU) who participated in Phase 3 clinical studies with     Phenoptin.   "
189674|NCT00332202|"     This clinical research study is to investigate the prevention of relapse in patients with     diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.      This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the     chance of receiving Enzastaurin is 2 to 1.   "
189675|NCT00332215|"     The primary objective of this study is to assess the safety of inhaled sodium pyruvate in     people with Cystic Fibrosis (CF). Further, to determine whether inhaled sodium pyruvate will     improve lung function, as determined by FEV1, or reduce inflammatory markers in induced     sputum of people with CF.   "
189678|NCT00332254|"     Individuals who have had a severe knee injury have an increased risk of developing arthritis     of the knee and at a much earlier age than would otherwise be expected. The swelling and     inflammation that occur after injury are believed to be responsible for this cartilage     damage. The cartilage (material that provides a cushion in the knee) is the primary     protection from what is called degenerative arthritis or osteoarthritis. We hope to reduce     this swelling and prevent the damage to cartilage that occurs after injury by injecting a     medication that blocks one of the proteins responsible for inflammation and cartilage     breakdown. This protein is called interleukin-1 and can be inhibited by an interleukin-1     receptor antagonist called anakinra. Anakinra will be injected directly into the injured knee     and response to the injection will be measured by symptoms and analysis of cartilage     breakdown in the knee fluid and blood.   "
189679|NCT00332267|"     The objective of the present protocol is to study whether a low level of oxygen in the blood     will affect the immune response to as well as cerebral blood flow and metabolism during an     infection and, conversely, whether the acute systemic and cerebral physiologic response to     hypoxia is modified by an ongoing inflammatory response.   "
189680|NCT00332280|"     The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer     patients with advanced disease.      The primary evaluation criterion is clinical benefit response.   "
189681|NCT00332293|"     The purpose of the study is to determine whether AL-15469A is safe and effective in the     treatment of bacterial conjunctivitis.   "
189682|NCT00332306|"     Protocol Summary      Title: Evaluation of safety and efficacy of two different once daily anti-retroviral     treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and     tuberculosis - Randomized Controlled Clinical Trial      Phase: Phase III trial      Population: 180 HIV-1 positive patients with tuberculosis      Number of Sites: Four.        1. Tuberculosis Research Centre, Chennai        2. Government Medical College, Vellore        3. Government Hospital of Thoracic Medicine, Tambaram        4. Government Rajaji Hospital, Madurai      Study Duration: 26 months including 24 months of ART.      Study Objectives:      Primary Objective To compare the efficacy and safety of two different once-daily     anti-retroviral treatment regimens (along with standard anti-tuberculosis treatment) in     patients with HIV-1 and tuberculosis, by using virologic end points.      Secondary Objective To compare the efficacy of antiretroviral treatment given under partial     supervision with unsupervised treatment (once a month supply).   "
189683|NCT00332319|"     This is a two-part study in which Part A will assess the effects of GW679769 after 1 dose on     the function of the nerves that supply the bladder. The technique for measuring the nerves     function is called Neurometry. Part B will assess the effect of repeat doses of GW679769 on     the bladder nerve function. Part B will also assess the effects of the drug on overactive     bladder symptoms using a three-day patient diary.   "
189684|NCT00332332|"     The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of     psoriasis in patients for a period of up to 1 year.   "
189685|NCT00332345|"     The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed     Combination in patients with glaucoma or ocular hypertension   "
189686|NCT00332371|"     The study objective is to clarify whether the application of CPFA (coupled plasma-filtration     adsorption) in addition to the current clinical practice is able to reduce mortality and     prevent organ failures in septic shock patients in intensive care unit (ICU).   "
189687|NCT00332384|"     The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed     Combination in patients with glaucoma or ocular hypertension   "
189688|NCT00332397|"     The purpose of this study is to evaluate the efficacy of 3 different drug-eluting-stent     platforms to reduce coronary artery reblockage after stent implantation   "
189689|NCT00332410|"     The purpose of this study is to determine whether patients with compromised renal function     (CrCl < 50mL/min) receiving intravenous voriconazole experienced any adverse effects related     to serum chemistries or other imaging studies of the kidney due to the potential accumulation     of the vehicle cyclodextran.   "
189690|NCT00332436|"     The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed     Combination in patients with glaucoma or ocular hypertension   "
189691|NCT00332449|"     Early breast feeding has shown to be important to mother-infant bonding and is associated     with longer duration of breast feeding. However, little data is available regarding its     contribution to glucose levels in the newborn infants. Newborns that are at risk to develop     hypoglycemia may benefit from early breast feeding if this appears to prevent post-partum     hypoglycemia.   "
189692|NCT00332462|"     The aim of this exploratory study is to evaluate the rejection rate in patients treated with     cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo     liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h     monitoring. In addition, this study will assess the safety of this treatment regimen.   "
189693|NCT00332488|"     to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin     versus combination metformin and a secretagogue   "
189694|NCT00332514|"     The purpose is to analyze whether a follow-up telephone call by a pharmacist after patient     discharge from the hospital can improve patient outcomes.      Patients will be interviewed via telephone within 72 hours of being discharged home from the     hospital. Patients will be questioned on three main topics. They are:        1. Medical care        2. Medications        3. Follow-up appointments      The purpose is to find out if people understand discharge medications, have obtained those     medications, are having any problems with their medications and have scheduled necessary     follow-up appointments. It will be determined if a telephone call by a pharmacist will     prevent patients from needing to go to the Emergency Room or being admitted back to the     hospital.   "
189695|NCT00332540|"     The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed     Combination in patients with glaucoma or ocular hypertension   "
189696|NCT00332553|"     This pilot study was designed to explore the effects of combined treatment with raloxifene     HCl 60 mg and oral 17 beta-estradiol 1mg/day on the number of vasomotor episodes (hot flashes     plus night sweats) in postmenopausal women discontinuing continuous combined hormone     replacement therapy (ccHRT) compared to women treated with raloxifene HCl 60 mg alone.   "
189697|NCT00332566|"     This booster study will assess the immunogenicity, reactogenicity and safety of a booster     dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy     children, 18 to 24 months of age, who received the same vaccine for primary vaccination.     Prior to the booster dose, this study will also assess the persistence of antibodies to the     vaccine antigen components administered in the primary vaccination course. The Protocol     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
189698|NCT00332579|"     The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in     kleptomania.   "
189699|NCT00332592|"     NEC is a serious inflammatory bowel disease, which almost only strikes infants with low birth     weight and low gestational age. The morbidity and mortality rates are high, and early     diagnosis and treatment is mandatory. The primary aim of the present study is to investigate     the clinical use of intragastric microdialysis and whether it is able to select patients, who     may benefit from either medical or surgical therapy. The aim of intraperitoneal microdialysis     is to evaluate whether changes in intraperitoneal microdialysis reflect the clinical outcome     after laparotomy.   "
189700|NCT00332605|"     The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine     (NAC) in combination with naltrexone in methamphetamine dependence.   "
189701|NCT00332618|"     The objective of the trial was to evaluate the efficacy and clinical safety and acceptability     of Oxygenated Glycerol Triesters in the relief of symptoms of xerostomia versus a reference     comparator.   "
189702|NCT00332631|"     At least 14% of patients develop kidney failure after cardiac surgery. Although this kidney     failure can usually be treated effectively, a longer stay in intensive care is often     required. While many patients suffer no long term ill effects after developing post-operative     kidney failure, some require long term kidney dialysis. The investigators also know that     patients who develop post-operative kidney failure are much more likely to die before they     leave hospital.      Why some people develop kidney failure after cardiac surgery is not known. However, doctors     suspect that the process of cardiopulmonary bypass (where the functions of the heart and     lungs are taken over by a machine during the operation, to allow the surgeon to operate)     overactivates some of the same mechanisms the body uses to defend itself against severe     infection. Many of the cell changes by which severe infection causes kidney failure also     occur after cardiopulmonary bypass. One of the main overactive defence mechanisms is the     release of highly toxic compounds derived from oxygen - a process called 'oxidative stress'.      Another well-known cause of oxidative stress is paracetamol (Panadol) overdose. In large     doses the oxidative stress caused by paracetamol damages cells in the liver, where it is     digested, and the kidney. N-acetylcysteine is a drug in common use for the treatment of     paracetamol overdose. Patients who would otherwise die of liver failure are routinely saved     by N-acetylcysteine, which acts as a strong anti-oxidant.      The investigators believe that N-acetylcysteine might similarly reduce the oxidative stress     which occurs during cardiac surgery, and so prevent or decrease the kidney failure which     occurs in many patients. The investigators hope to give N-acetylcysteine (in similar doses to     those used safely for paracetamol poisoning) to patients during, and for a day after cardiac     surgery, and compare the effects with patients who have not had N-acetylcysteine. The drug,     or a 5% glucose placebo, will be given through the drip which is present in all cardiac     surgery patients. Whether a particular patient receives the drug or placebo will be decided     at random, and neither the patient nor the investigators will know which has been given. The     investigators will measure kidney function before and after the operation using the standard     tests which are performed for the purposes of clinical care of every patient. Also, the     investigators will do an extra test involving the collection of urine (from the urinary     catheter every patient has after cardiac surgery), which provides an even better measure of     kidney function. This is a potential benefit to the patient, as while this test is not     routinely performed, the results will be available to the doctors in the intensive care unit.     The investigators will also take four 20ml samples of blood, spaced before, during, and after     the operation, from the arterial catheter routinely inserted in every patient. This is an     insignificant amount of blood compared to that taken for other tests, and would have no     adverse effects. This blood would be used to measure oxidative stress, and also some of the     proteins inside the blood cells which are responsible for creating the toxic oxygen     compounds. In this way the investigators will discover not only the effect of     N-acetylcysteine, but the mechanism of that effect.      N-acetylcysteine is routinely used to treat paracetamol overdose with few side effects. An     itchy skin rash is the only common side effect. Sometimes patients develop nausea and     vomiting, but the treatment for this is usually very effective, and the drug will be stopped     if it occurs. Rarely, as with all drugs, allergic reactions have been reported, but there are     no other reported adverse effects.      There will be no extra risk to a patient who participates in the study, and no discomfort     other than that normally associated with cardiac surgery. The itchy rash which occasionally     develops with N-acetylcysteine would occur under anaesthetic, and would almost certainly be     gone by the time the patient wakes up.      Informed consent will be obtained from the patient prior to the operation by one of the     investigators or the ICU research nurse.   "
189703|NCT00332644|"     The proposed work will advance the understanding and effectiveness of tobacco dependence     treatment and result in more smokers quitting successfully.   "
189704|NCT00332657|"     The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15     mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular     degeneration (AMD) in patients who are at-risk for progressing to wet AMD.   "
189705|NCT00332670|"     The purpose of this study is to investigate the following two hypotheses:        1. Treatment with bright light improves their sleep, mood, concentration and          self-sufficiency of elderly depressed subjects. This clinical improvement is accompanied          by decreases in cortisol/DHEA ratio and increases in melatonin concentration in urine          and saliva.        2. The eventual beneficial effect of bright light treatment can be predicted by the          presence of sleep-wake rhythm disturbances as found using muscle activity registration,          and by cortisol/DHEA and melatonin concentrations in saliva and urine over the day and          the night.   "
189721|NCT00332878|"     This study will evaluate the effectiveness of Stepping Stones, an HIV-prevention education     program, versus a brief HIV-focused intervention, in improving sexual health and preventing     HIV infection in young residents of rural South African communities.   "
189722|NCT00332891|"     The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with     Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 350 mg     and 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder     (GAD). The secondary objectives are to evaluate the efficacy of SR58611A on disability and     quality of life in patients with GAD and to evaluate safety of SR58611A   "
189723|NCT00332904|"     The study´s purpose is to investigate the effect of beta blockade or aldosterone antagonist     therapy on oxygenation, peripheral and cardiac hemodynamics and humoral systems, in patients     with liver cirrhosis.   "
189724|NCT00332917|"     This is a multicenter, 6 months open label safety extension study for all patients who are     willing and eligible to continue from the pivotal, double-blind S308.3.001 trial   "
189706|NCT00332683|"     Anterior cervical spine surgery (ACSS) is one of the most common procedures performed by     spinal surgeons. It is associated with a 30-50% risk of developing swallowing difficulties     (dysphagia). Although these difficulties usually improve within 6 months, for some it remains     a significant and persistent problem.      We hypothesize that lowering the cuff pressure will lower the risk of injury to soft-tissues     in the neck that are important to swallowing function. Our objective in this study is to     demonstrate a lower occurrence of swallowing problems after anterior cervical spine surgery     in patients with lower endotracheal tube cuff pressure during surgery.      Forty patients will be randomly assigned to a treatment group or control group. The treatment     group will have the cuff pressure maintained at 15mmHg during the entire duration of the     procedure. The control group will have the cuff pressure monitored without manipulation.     After surgery soft-tissue swelling will be assessed on the five routine neck x-rays taken. In     addition, 3 questionnaires completed before surgery and at each scheduled follow-up     appointment will measure and track changes in swallowing over time and assess the impact of     swallowing function on the patient's overall health. The results of this study may show that     making a minor, inexpensive change during an operation may lower the risk of swallowing     difficulties after a relatively common surgery.   "
189707|NCT00332696|"     To evaluate in combination with corticosteroid and local standard medical care the efficacy     and safety of long-acting octreotide compared to placebo for the treatment of symptoms of     inoperable bowel obstruction in patients with peritoneal carcinomatosis   "
189708|NCT00332709|"     This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate     the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women     with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after     resection of the tumor. Patients were treated with letrozole 2.5 mg orally per day or     letrozole 2.5 mg orally per day in combination with zoledronic acid 4 mg/6 months as an     infusion.      This trial did not recruit patients in the United States.   "
189709|NCT00332722|"     1. To demonstrate whether:           i. Facet joint nerve blocks have therapeutic value beyond the duration of local          anesthetic effect.           ii. Adjuvant medications (Sarapin and Depo-Medrol) provide additional relief of cervical          facet joint pain when used with facet joint nerve blocks.        2. To demonstrate whether or not there are clinically significant improvements in function          of patients who receive cervical facet joint nerve block with or without Sarapin and          Depo-Medrol (Group II) compared to patients randomized to Group I who receive only local          anesthetic blocks.        3. To determine the adverse event profile in both groups.   "
189710|NCT00332735|"     The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for     outpatient lower limb surgery. Onset and recovery times of sensory and motor blockade will be     compared.   "
189711|NCT00332748|"     The purpose of this study is to determine what effects Esomeprazole (Nexium) has on     increasing or decreasing the amount of oral taxane in the blood, and to determine the safety     of oral taxane and effect of oral taxane on the cancer.   "
189712|NCT00332761|"     The purpose of this study is to determine if Caduet will lower blood pressure to <140/90 mmHg     and lower LDL Cholesterol to <100 mg/dL in subjects with hypertension and dyslipidemia who     are not currently being treated for these medical conditions.   "
189713|NCT00332774|"     The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS     0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days     following surgery.   "
189714|NCT00332787|"     This study will determine the optimal length of continuation treatment with fluoxetine for     children and adolescents with major depressive disorder, as well as the factors that may     contribute to positive response during acute and continuation treatment.   "
189715|NCT00332800|"     Undernutrition after stroke is frequent and is due to cognitive impairment, visuospatial     perceptive deficits, hemiparesis, depression and dysphagia. The impact of intensive     nutritional supplementation on functional outcome measures in undernourished stroke patient     has not been studied.   "
189716|NCT00332813|"     We propose to develop and pilot test an intervention that addresses both sex- and     drug-related HIV risk behavior among pregnant women in drug treatment. In the first phase of     the study, we will conduct focus groups with pregnant women in drug treatment, as well as a     focus group with their treatment providers, in order to determine key areas of emphasis for     an intervention in this population. We will then develop an HIV risk behavior intervention     for pregnant women in drug treatment, pilot the intervention with 20 women, and elicit their     feedback regarding the intervention. Following refinement of the intervention, we will     conduct a small randomized trial (n=60) to examine the impact of the intervention compared to     standard care (SC). We expect that, relative to SC, participants randomized to the     intervention condition will have lower levels of sex- and drug-related HIV risk behavior.   "
189717|NCT00332826|"     The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin     compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes     mellitus and concurrent asthma.   "
189718|NCT00332839|"     Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant     recipients to prevent graft rejection, may cause renal impairment. The aim of this study is     to assess whether a CNI-free regimen with enteric-coated mycophenolate sodium and everolimus     is as safe and well tolerated as a standard regimen consisting of enteric-coated     mycophenolate sodium and cyclosporine microemulsion without a compromise in therapeutic     efficacy while resulting in an improved renal function.   "
189719|NCT00332852|"     This is a prospective open-label one-arm phase III trial designed to evaluate the safety and     efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in     postmenopausal patients with primary breast cancer.      This trial is not recruiting patients in the United States.   "
189720|NCT00332865|"     Background: Dysphagia is a common side effect after radiotherapy for haed and neck cancer     patients. It may be worsened by immobility of the throat during tube feeding. Hypothesis:     Exercises may prevent or reduce late dysphagia. Method: Phase I study to identify the     tolerated intensity of exercises and establish the method of measuring training intensity and     dysphagia measurement. Endpoint: Objective dysphagia using VF and FEESST. The HN swallowing     and HN pain endpoint of EORTC H&N35 questionnaire. Weight loss, duration of tube feeding.   "
189725|NCT00332930|"     The objective of this phase I/II therapeutic human immunodeficiency virus (HIV) vaccine     candidate study is to provide proof of concept for a HIV antigen delivery system in terms of     safety, virological effects and selected immune responses in HIV infected individuals after     cessation of antiretroviral combination therapy (ART).   "
189726|NCT00332943|"     The purpose of this study is to determine whether Barium or BariumFerumoxsil is better for     fecal tagging in MR colonography. Patients referred to colonoscopy are offered MR     colonography before colonoscopy. Two days before colonography, patients ingest either a     contrast agent A (200 ml Barium sulphate solution 1g/ml)) four times a day or a 200 ml     contrast agent B (Barium sulfate(25%) and Ferumoxil(75%)) four times a day, which will render     fecal masses invisible on the following MR colonography. The patients are randomised to     either contrast agent A or B. The examinations are evaluated by two independent blinded     readers, who will rate the tagging quality of the contrast agents. The quality of tagging     will be rated by a Visual Analog Scale (VAS) and Relative contrast (ReCon = Iwall - Ilumen/     Iwall + Ilumen).   "
189727|NCT00332956|"     This Phase 2(a) clinical trial is designed as a dose-blinded, block-randomized, multi-center     study to select a dosage and schedule of rF1V vaccine for further studies based on the immune     response up to Day 210. Additional immunogenicity and safety/reactogenicity data will be     collected through Day 540. Selection of dosage and schedule will be based on GMCs and     seroconversion rates for anti-F1, anti-V and anti-rF1V antibody titers. Approximately 400     healthy adult volunteers will be enrolled (100 per group) in this study.   "
189728|NCT00332969|"     This study will investigate the efficacy of treatment with octroetide in patients with     primary inoperable thymoma to reduce tumor size.   "
189729|NCT00332982|"     The pragmatic issue at hand how to get physicians and nurses to use best practices… and how     to measure consequences of their implementation. This is the science of knowledge     translation, which we are realizing is an organic entity. As part of our Critical Care     Strategy our goal is to improve the quality and continuity of critical care within our health     care system. Toward this goal we are implementing a program which links 16 Ontario hospitals     through their critical care units in a Provincial Network.   "
189730|NCT00332995|"     This Phase I trial will assess the feasibility of using a vaginal ring to deliver the     candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13     healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical     and laboratory assessments. Feasibility of drug delivery will be assessed by measuring     dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue,     and plasma.   "
189734|NCT00316069|"     This study is designed for the collection of stem cells from the bloodstream for use in     research studies. These cells will be studied to determine if they have unique features     particular to the donor that may or may not affect their use for developing new treatments.      Volunteers with or without a blood disease may be eligible to donate stem cells for this     study. Women who are pregnant or breastfeeding may not enroll.      Donors are evaluated with a medical history and physical examination, blood tests and an     ultrasound examination of the spleen. They then undergo stem cell mobilization and apheresis     as follows:      Donors are given injections of a hormone called G-CSF every day for 5 days to stimulate     release of stem cells from the bone marrow into the bloodstream for collection. On the day of     the last injection, donors undergo apheresis to obtain white cells and stem cells. For this     procedure, blood is withdrawn through a catheter (plastic tube) placed in a vein and directed     into a machine where the white cells and stem cells are separated from the rest of the blood     by a spinning process. These cells are extracted and collected in a bag inside the machine,     and the rest of the blood is returned to the donor through a second catheter in a vein in the     other arm. The procedure takes 4 to 5 hours.   "
189735|NCT00316082|"     The purpose of this trial is to understand if saxagliptin is more effective than placebo as a     treatment for type 2 diabetic subjects who are not controlled with diet and exercise   "
189736|NCT00316095|"     This study will investigate two registered drugs, one for the treatment of high blood     pressure and one for the treatment of elevated cholesterol. High blood pressure     (hypertension) is a common medical condition affecting millions of people worldwide. A wide     variety of effective drug treatments is available to reduce blood pressure. Elevated     cholesterol (hypercholesterolemia) is a common medical condition affecting people worldwide.     A wide variety of effective drug treatments is available to reduce cholesterol levels.      Hypertension and hypercholesterolemia often occur together. They are both important risk     factors for the development of heart and vessel diseases (e.g. heart attack or stroke).     Current guidelines advise treatment of high blood pressure and elevated cholesterol to reduce     the risk of cardiovascular diseases. This study will test the simultaneous use of a drug to     reduce blood pressure and a drug to reduce elevated cholesterol. Both drugs are registered     and are effective. The drug for treatment of high blood pressure is telmisartan Micardis).     The drug for treatment of elevated cholesterol is simvastatin (Zocor). Since hypertension and     hypercholesterolemia frequently occur together, the purpose of this study is to investigate     whether both drugs can be used simultaneously. A low dose and a high dose of these drugs will     be used. It will be investigated whether each of the drugs is still as effective when given     together, at the same time of day, with the other drug.   "
189737|NCT00316108|"     The purpose of this study is to determine whether morbidity and mortality for high-risk     surgical patients treated with the Carotid Wallstent in conjunction with the FilterWire EX     and EZ System distal protection device will be less than or equal to that of objective     performance criteria (OPC) derived from historic controls undergoing surgical intervention     with a carotid endarterectomy (CEA).   "
189738|NCT00316121|"     The purpose of this study is to determine the safety and effectiveness of HEALOS compared     with autograft using the transforaminal lumbar interbody fusion (TLIF) method.   "
189739|NCT00316134|"     The purpose of this clinical trial is to evaluate the ability of various biomarkers measured     in serum and/or pleural fluids to estimate the risk of finding cancer in patients with     undiagnosed pleural effusions. An algorithm for prediction of the risk of finding cancer in     the patient using an optimal combination of markers will be developed, and patients will be     categorized as having a low, moderate, or high risk of finding cancer that might be used to     more effectively triage patients.   "
189740|NCT00316147|"     In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will     be randomly allocated into two groups:        -  one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B          virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at          6-10-14 weeks of age        -  the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of          age   "
189741|NCT00316160|"     Effects of two depression medication on sexual functioning   "
189742|NCT00316173|"     This study was designed to find the most effective and safest doses of both HYCAMTIN and     CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow     researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN.   "
189743|NCT00316186|"     This study was designed to find the safest and most effective dose of a combination of two     chemotherapy drugs, Hycamtin® (topotecan) and Paraplatin® (carboplatin), in people with     extensive disease small cell lung cancer.   "
189744|NCT00316199|"     The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel     combination administered on a 3-weekly schedule in Chinese patients with unresectable,     locally recurrent breast cancer or metastatic breast cancer.   "
189745|NCT00316212|"     The purpose of this trial is to identify a dose or doses of INS50589 intravenous infusion     that are well-tolerated and which reduce postoperative bleeding and blood product     transfusion.   "
189746|NCT00316225|"     This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer     patients with fluid around their lungs or abdomen.   "
189747|NCT00316238|"     To investigate dose-response of Rapid Acting Intramuscular Olanzapine in Agitated Patients     with Schizophrenia   "
189748|NCT00316251|"     The purpose of this study is to determine the effects of Power Plate vibration therapy on     balance as measured by the NeuroCom Balance Master.   "
189749|NCT00316264|"     This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and     palivizumab were administered sequentially to high-risk children during the same respiratory     syncytial virus (RSV) season. A control group was administered only motavizumab.   "
189750|NCT00316277|"     The purpose of this study is to determine whether treatment outcome for subjects dependent on     prescription opioid analgesics can be improved by adding individual drug counseling to the     prescription of buprenorphine/naloxone with standard medical management. This will be     examined during: a) an initial four-week treatment with taper; b) a 12-week stabilization     treatment for those who do not respond successfully to the initial treatment; and c) a     long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.   "
189751|NCT00321646|"     The main purpose of this trial is to collect information and to evaluate the effects, good or     bad, the combination of docetaxel and bevacizumab has on patients with high risk prostate     cancer that are undergoing radical prostatectomy.   "
189752|NCT00321659|"     The overall objective of this work is to improve treatment outcomes for persons with     fibromyalgia by optimizing the approach to self-management. The purpose of this research     project is to evaluate and compare, in a randomized, controlled trial involving 200 women,     the short and long-term effectiveness of four approaches to fibromyalgia self-management for     improving health and functional status, self-efficacy, and symptom severity. Additionally, we     will also examine the effect of each intervention on health care usage. We will assess the     following 16-week interventions:        -  cardiovascular and flexibility exercise        -  strength training, cardiovascular and flexibility exercise        -  Arthritis Foundation's Fibromyalgia Self-Help course        -  a combination of the Fibromyalgia Self-Help Course and strength training exercise          interventions   "
189753|NCT00321672|"     The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or     60 minutes for the treatment of painful HIV-associated neuropathy.   "
189754|NCT00321685|"     This phase II trial studies how well giving bevacizumab, radiation therapy, and combination     chemotherapy works in treating patients who are undergoing surgery for locally advanced     nonmetastatic rectal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor     growth in different ways. Some find tumor cells and kill them or carry tumor-killing     substances to them. Others interfere with the ability of tumor cells to grow and spread.     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine,     may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as     capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     bevacizumab together with radiation therapy and combination chemotherapy before surgery may     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.     Giving bevacizumab together with combination chemotherapy after surgery may kill any tumor     cells that remain after surgery.   "
189755|NCT00321698|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving radiation therapy     together with chemotherapy before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed.      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when     given together with radiation therapy and to see how well they work in treating patients who     are undergoing surgery for high-risk localized prostate cancer.   "
189756|NCT00321711|"     The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence     of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet     transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS)     receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the     appropriate dose and schedule, will result in reduction in the incidence of clinically     significant thrombocytopenic events in low or intermediate risk MDS subjects receiving     hypomethylating agents.   "
189757|NCT00321724|"     This phase II trial is studying how well AZD2171 works in treating patients with relapsed or     refractory B-cell chronic lymphocytic leukemia. AZD2171 may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth and by blocking blood flow to the     cancer cells   "
189759|NCT00321750|"     Background and hypothesis. Oral erosive lichen planus (OELP) is a severe form of mucosal     lichen planus. Lesions often induce intense pain and limit feeding. Its course is chronic     with flares and spontaneous remissions are rare. Treatment is difficult: topical steroids are     usually used first but antimalarials, oral retinoids, systemic steroids, immunosuppressive     drugs and even extracorporeal photochemotherapy can be necessary for treating severe forms.     The need for novel therapies with less morbidity is obvious. Calcineurin inhibitors have a     theoretical interest in treating OELP: this has been emphasized by several open studies     performed with topical tacrolimus. The effectiveness of 1% pimecrolimus cream has been     suggested by a few case reports and by one recent comparative study which confirmed the     potential interest of topical pimecrolimus in treating OELP. The absorption of pimecrolimus     through human mucosa is still unknown. Its application on ulcerative lesions such as OELP     ones, could lead to significant systemic levels of the molecule.      Objective: To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen     planus (OELP) and to assess its tolerance.   "
189760|NCT00321763|"     The purpose of this phase IIb study is to demonstrate the consistency of three lots of an     adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to     Fluarix™ administered intramuscularly in elderly aged 60 years old and above.   "
189761|NCT00321789|"     We examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient     treatment adherence. A randomized controlled trial compared a one-year, telephone-based     patient-spouse intervention to usual care. The primary outcome was LDL-C measured three times     (baseline, 6 months, 11 months); secondary outcomes were adherence to medication, diet, and     exercise, also assessed at baseline, 6 months, and 11 months.   "
189762|NCT00321802|"     The purpose of this study is to determine the effect of statin therapy for prevention of     atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial     fibrillation in the absence of significant coronary artery disease.   "
189763|NCT00321815|"     To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in     patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one     prior chemotherapy regimen.   "
189893|NCT00323544|"     This study will investigate whether the simplified regimen of a once daily fixed dose     combination of Truvada (emtricitabine and tenofovir disoproxil fumarate [DF]) will be     associated with a reduced rate of adverse events, seen with long term use of antiretrovirals,     as well as improved adherence compared to a twice daily fixed dose combination of Combivir.   "
189764|NCT00321828|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab     may also stop the growth of colon cancer by blocking blood flow to the tumor. Giving     combination chemotherapy together with bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed     by surgery.   "
189765|NCT00321854|"     This is a double blind, placebo-controlled clinical trial of 15 months duration designed to     examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in     patients with new onset Parkinsons disease   "
189766|NCT00321867|"     The purpose of this study is to determine whether adding a graft during a rectocele repair     will improve the success rate of the repair.   "
189767|NCT00321880|"     RATIONALE: Supportive care, such as healing touch, may improve quality of life in patients     receiving chemotherapy for acute leukemia.      PURPOSE: This clinical trial is studying how well healing touch works in treating patients     receiving chemotherapy for acute myeloid leukemia or acute lymphocytic leukemia.   "
189768|NCT00321893|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of budesonide may keep lung cancer from forming in patients with lung     nodules.      PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in     treating patients with lung nodules who are at high risk of lung cancer.   "
189769|NCT00321906|"     The purpose of this study is to compare the safety and effectiveness of two different     anti-rejection drug regimens.   "
189770|NCT00321919|"     This study will evaluate whether anemia prevention with NeoRecormon has an additional impact     on reducing cardiovascular risk over conventional anemia treatment in patients mostly with     stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is     2+ years and the target sample size is 500+ individuals.   "
189771|NCT00321932|"     RATIONALE: Zoledronic acid, vitamin D, and calcium may prevent bone loss in patients who are     undergoing donor stem cell transplant.      PURPOSE: This randomized phase II trial is studying how well zoledronic acid works in     preventing osteoporosis in patients undergoing donor stem cell transplant.   "
189772|NCT00321945|"     It is well known that atrial fibrillation (AF) and atrial flutter occur frequently after most     types of cardiac surgeries.(1-4) Postoperative AF is associated with significant morbidity,     longer hospital stay, and higher related costs. Currently, it is common procedure to     premedicate patients with antiarrhythmic drugs for elective cardiac surgeries. Treatments     such as beta blockers, Amiodarone, and electrical pacing are used to help prevent the     morbidity associated with pot-operative AF.(5)      Renin-angiotensin system (RAS) activation may contribute to AF. Several clinical trials have     suggested that inhibitors of this system may reduce the incidence of AF.(6-12) Patients with     AF are known to have increased levels of angiotensin converting enzyme (ACE) and some types     of angiotensin receptors.(13-15) Data from animal studies performed by our group suggest that     cardiac ACE overexpression may lead to arrhythmic ion channel changes.(16;17) Although not     studied in this group yet, it would be reasonable to conclude that the use of ACE inhibitors     and angiotensin receptor blockers (ARBs) would decrease the incidence of AF in post-operative     patients, too   "
189900|NCT00323635|"     This study is being done to compare frequency of urination during the night when women take     tolterodine tablets vs. when they take placebo tablets.      We will also measure whether between these two treatment conditions there are any differences     in women's sleep, mood and performance on cognitive tests.   "
189773|NCT00321958|"     The purpose of this study is to confirm the effectiveness and safety of a new medical device     which sprays liquid nitrogen through an upper endoscope (cryotherapy) to treat Barrett's     esophagus with high-grade dysplasia and early esophageal cancer. It is hypothesized that this     treatment will remove the abnormal lining of the esophagus and allow the normal esophageal     lining to return.   "
189774|NCT00321971|"     This study evaluates the effectiveness of a problem-solving training program in preventing     depression in the spouses or family caregivers of persons with mild cognitive impairment or     early dementia.   "
189775|NCT00321984|"     The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified     release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and     nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal     reflux disease (GERD).   "
189776|NCT00321997|"     The purpose of this study is to compare the ability of different doses of pegaptanib sodium     to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or     impriving vision in patients with wet AMD when compared to placebo injections.   "
189777|NCT00322010|"     To study all ICU patients with an independent baseline functional status, who experience a     critical illness requiring intubation and mechanical ventilation, evaluating the role of     protocol-directed, early physical and occupational therapy on the incidence of critical     illness associated functional debilitation. Our goal is to hasten the recovery of independent     physical functioning as well as to reduce ICU delirium in the group of patients who begin     this intervention from the earliest hours of ventilator dependence.   "
189778|NCT00322023|"     This study will determine whether increasing D-serine within the body will improve negative     symptoms and cognitive impairments in people with schizophrenia.   "
189779|NCT00322036|"     This is a multinational, randomized, double blind, placebo controlled, parallel group study     comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo.     Study subjects will have the diagnosis of mild dementia of the Alzheimer's type. Subjects may     be taking approved medication for Alzheimer's disease provided the dose has been stable for     at least 6 months.   "
189789|NCT00322179|"     The response rate to interferon-based anti-viral therapy for chronic hepatitis C is lower in     patients who are obese. However, it is not clear whether this is related to suboptimal dosing     of the medication or alterated response in obese patients. Alterated immune response had been     reported in obese patients. The goal of current study is to determine the immune response to     interferon in obese compared to non-obese chronic hepatitis C in an tissue culture system.   "
190117|NCT00333281|"     This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the     effects on vision of six months of daily dosing of 5 mg tadalafil or 50 mg sildenafil     compared with placebo.   "
189780|NCT00322049|"     The main target populations for the tetravalent live attenuated dengue virus vaccine are     indigenous populations, especially infants less than 2 years old, residing in areas of the     world endemic for dengue and at risk of developing dengue hemorrhagic fever (DHF). The     presence of maternal dengue antibody during the first year of life makes it unlikely that a     vaccine given during that time will have long-term efficacy, as the vaccine virus would     likely be neutralized prior to necessary replication. Children older than 18 months may have     preexisting flavivirus antibody. Therefore, vaccination of infants living in Thailand early     in the second year of life (between the ages of 12 and 18 months) seems most beneficial. The     aim of this trial is to evaluate the safety and immunogenicity of a two-dose schedule of a     tetravalent live attenuated dengue vaccine in flavivirus antibody naïve infants beginning at     12-15 months of age.        -  To assess the kinetics of dengue neutralizing antibodies to each dengue virus serotype          one and four years following dose 2 of dengue/control vaccination in the setting of          potential wild-type dengue virus exposure.        -  To assess the immunogenicity, the safety and reactogenicity of a booster dose of dengue          vaccine administered at Year 3 following primary vaccination.   "
189781|NCT00322062|"     The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium     phosphate solution already on the market. Efficacy of each bowel preparation, safety and     acceptability will be assessed.   "
189782|NCT00322075|"     Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic     patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of     HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal     and prandial insulin, satisfaction with treatment, incidence of adverse events.   "
189783|NCT00322101|"     RATIONALE: Giving chemotherapy, such as fludarabine phosphate, busulfan, and     cyclophosphamide, and total-body radiation therapy before a donor peripheral stem cell     transplant helps stop the growth of cancer cells. It may also stop the patient's immune     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are     infused into the patient they may help the patient's bone marrow make stem cells, red blood     cells, white blood cells, and platelets. It is not yet known whether low-dose chemotherapy     and total-body radiation therapy is more effective than high-dose chemotherapy in treating     patients with myelodysplastic syndrome or acute myeloid leukemia.      PURPOSE: This phase III trial is studying low-dose conditioning to see how well it works     compared to high-dose conditioning followed by peripheral blood stem cell transplant in     treating patients with myelodysplastic syndromes or acute myeloid leukemia   "
189784|NCT00322114|"     RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from     forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may     keep prostate cancer from forming.      PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing     prostate cancer in healthy participants.   "
189795|NCT00322257|"     This trial is conducted in the United States of America (USA) and Canada. The aim of this     research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary     safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous     insulin aspart both in combination with insulin determir in Type 1 Diabetes.   "
189796|NCT00322270|"     To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events,     serious adverse events and major bleeding events for up to 120 minutes following the     instillation of study drug to an occluded central venous access device.   "
189785|NCT00322127|"     This study will determine how safely and well people can tolerate AMD3100 at larger than     normal doses to mobilize CD34+ cells, (stem cells). AMD3100 is a new drug designed to     mobilize stem cells for transplantation in cancer patients. It pushes those cells into the     circulation, making it easier to collect them, and it temporarily increases the number of     stem cells in a person's blood.      Patients ages 18 to 50 in good health and who are not pregnant or breastfeeding may be     eligible for this study. They will undergo the following tests and procedures:        -  History and physical examination        -  Review of medications, including those prescribed and over-the-counter, as well as          nutritional supplements        -  Blood tests for liver, kidneys, and other functions; and for infections including          hepatitis and AIDS        -  Pregnancy test        -  Electrocardiogram      On the day they receive AMD3100, patients will be admitted to the Clinical Center. They will     receive two doses, injected under the skin, at intervals separated by 14 to 90 days. Dose     levels are 240 and 320 micrograms/kg and 400 and 480 micrograms/kg. For 24 hours following     the first AMD3100 administration, blood will be collected periodically through a plastic tube     at amounts dependent on doses of AMD3100 given. If patients receive one of the two highest     doses, their heart rhythm will be monitored continuously during the hospital stay. From 7 to     10 days following administration of AMD3100, patients will give blood samples to monitor the     effects. The second dose of AMD3100 will be given 14 to 90 days after the first one. Patients     will return to the Clinical Center for the same procedures as done previously, but the dose     of the drug will be higher.      Risks involve side effects of AMD3100. In previous studies, patients who received the drug     experienced a temporary increase in white blood cell counts. Serious side effects have     included abnormally low platelet clot, abnormal heart rhythm, and low blood pressure.     Patients will be carefully monitored for such effects.   "
189786|NCT00322140|"     Background:        -  CDDO is a novel synthetic triterpenoid which is a potent multifunctional molecule. It          induces apoptosis in vitro in malignant cells through both intrinsic and extrinsic          pathways, and it controls cellular differentiation, apoptosis, and growth inhibition by          serving as a ligand for the transcription factor peroxisome proliferator activator          receptor-gamma (PPAR gamma).        -  Based on in vitro activity, it holds considerable promise as a novel anti-tumor agent          against a wide range of malignancies by concurrently targeting multiple pathways leading          to oncogenesis.        -  In vivo data demonstrates that the drug is well tolerated in dogs, and has anti-tumor          effects, dependent upon dose schedule.      Objectives:      Primary:        -  To determine the dose limiting toxicities, toxicity profile, and maximum tolerated dose          of CDDO when administered in adult patients with solid tumors and lymphomas.        -  To characterize the pharmacokinetics of CDDO.      Secondary:        -  To obtain preliminary evidence of anti-tumor activity of CDDO in this population.        -  To evaluate the in vivo molecular and biological effects of CDDO by assessing changes in          biomarkers of apoptosis and cell cycle arrest.      Eligibility:        -  Patients with advance, histological-confirmed malignancies refractory to standard          therapy or for which no standard therapy exist.        -  Patients should have adequate liver, renal and bone marrow function.      Study Design:        -  Accordingly with the accelerated titration design 4B, dose levels will initially be          increased at 100% increments, and one new patient per dose level will be treated per          4-week course.        -  The accelerated phase ends when one patient experiences DLT during any course of          treatment or when two different patients experience grade 2 toxicity during first course          of treatment.        -  When the first instance of grade 2 toxicity is observed two additional patients must          have been treated at that dose, or a higher dose, (during any course) without          experiencing moderate or worse toxicity, in order that the accelerated phase continue.        -  When the accelerated phase ends, dose-escalation will revert to a more conservative          modified Fibonacci scheme with 40% dose-step increments, with at least 3 patients          treated per dose level.   "
189787|NCT00322153|"     The objective of this study is to evaluate the safety, tolerability, and efficacy of     memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of     the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).   "
189788|NCT00322166|"     The proposed study will determine the effect of a public health strategy (ie. increased sun     light exposure and increased calcium intake) to reduce falls in older people in residential     care using a randomised trial. The primary hypothesis of the trial is that increased     appropriate sun light exposure will reduce falls, improve 25 hydroxy vitamin D (25OHD) levels     and lower parathyroid hormone (PTH) levels. Secondary hypotheses are that the intervention     will reduce accelerated bone turnover, reduce fractures, improve motor function and improve     mood.   "
189790|NCT00322192|"     The purpose of this study is to test the hypothesis that adding functional strength training     to UK conventional therapy improves muscle function and walking than either UK conventional     therapy alone or increased intensity of UK conventional therapy   "
189791|NCT00322205|"     The overall goal of this research is to increase our understanding of the role of individual     genetic differences in response to bupropion treatment and the psychobiological mechanisms by     which genetic and treatment factors interact in the smoking cessation process. The ultimate     objective is to provide information necessary to match bupropion vs. behavioral counseling     cessation treatment to those smokers with the greatest need and likelihood of benefit. This     study is a double-blind randomized placebo-controlled clinical trial of bupropion HCL (brand     name Zyban) in adult male and female smokers. The factorial design includes one treatment     factor (bupropion 300 mg/day + counseling vs. placebo + counseling) and several subject     factors (e.g. genotype, personality). Smoking history, psychological status will be assessed     at baseline and blood will be drawn for genotyping. Bupropion or placebo will be delivered     over a 10-week treatment period and subjects will be instructed to quit smoking after two     weeks of medication (week 3 of treatment). All subjects will also receive a 7-week group     behavioral smoking cessation treatment (over an 11 week period). This study may yield     information that will help clinicians identify the most effective smoking cessation treatment     for a particular patient, based on his/her background.   "
189792|NCT00322218|"     This study will treat patients with diffuse large B-cell lymphoma whose disease is in     complete remission due to previous treatment with CHOP-R. Half of the patients will receive     Zevalin and the other half will receive no further anti-cancer treatment. The two patient     groups will be compared to determine if Zevalin given after CHOP-R therapy provides greater     benefits than receiving no additional anti-cancer therapy after CHOP R.   "
189793|NCT00322231|"     The purpose of this study is to determine whether the investigational zoster vaccine, is     generally well tolerated when administered to participants with a history of herpes zoster.   "
189794|NCT00322244|"     The study is a randomized, controlled clinical trial that investigates the efficacy ogf     massage therapy for 66 patients with pain secondary to osteoarthritis of the knee. It is a     wait-list design where subjects and randomly assigned to either Group A or Group B. Group A     receives two months of massage while Group B is wait-listed, receives two months of usual     care. At the conclusion of the wait period, Group B receives two months of massage. In all     cases, subjects continue to receive conventional medical care for their OA symptoms.      Outcome measures include a WOMAC questionnaire, a visual analog pain scale, time to walk     fifty feet and range of motion of the knee (using a goniometer). A research assistant,     competent in appropriate subject assessment obtains the outcome measures. Change in     medication use is tracked by the use of patient diaries. Assessments of subjects, occurs at     baseline, and week 8 and 16 in both the intervention and control groups.   "
189797|NCT00322283|"     The purpose of this study is to determine whether it is effective in the treatment of     exercise-induced asthma and investigate the safety of oglemilast.   "
189798|NCT00322296|"     Parapsoriasis is a term that refers to a precursor stage of cutaneous T-cell lymphoma     (CTCL)/mycosis fungoides(MF). Complete responses (clearing) of early presentations of CTCL/MF     have been shown to be associated with long-term survival and cure. Induction of a complete     response in parapsoriasis, therefore, would seem to be a desirable therapeutic endpoint.     Bexarotene 1% gel has been approved for treatment of cutaneous T-cell lymphoma (mycosis     fungoides). The goal of this study is to evaluate the tolerability, safety and efficacy of     bexarotene 1% gel in patients with parapsoriasis.   "
189799|NCT00322309|"     This research study is being done to look at the safety of the medication Mirtazapine     (Remeron) in people who have cocaine dependence and depression. Hypotheses I. Cocaine usage     will be less in the mirtazapine treatment group (MG) than in the control group (CG). II. A     greater increase in Clinician Global Impression (CGI) score will be observed in the MG than     in the CG. Secondary Hypotheses: I. A greater decrease in Hamilton Rating Scale for     Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) scores will be observed in     the MG than in the CG. II. A greater decrease in HIV risk behaviors will be observed in the     MG than in the CG. III. A greater improvement in sleep structure will be observed in the MG     than in the CG. IV. The proportion of subjects experiencing severe adverse drug reactions     that necessitate termination from the study by one of the study clinicians will not differ     between the MG and CG. V. Retention will be greater in MG than in CG.   "
189800|NCT00322322|"     Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an     anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac     dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in     hemodialysis patients. The patients should be included in the first month after the start of     chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up     during one year.   "
189801|NCT00322335|"     This protocol posting deals with objectives & outcome measures of the extension phase at     Months 18, 30, 42, 54 and 66 post booster. The objectives & outcome measures of the primary     phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives     & outcome measures of the Booster phase/study are presented in a separate protocol posting     (NCT number =NCT00323050).      The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib     antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
189832|NCT00322738|"     This study will attempt to find out what effect mosquito insecticides have on the     transmission of malaria in The Gambia. Eight hundred healthy men and women, aged 18 to 40     years, living in selected villages east of Farafenni town in The Gambia, West Africa will be     screened for parasites. About 552 of these people are expected to be free of malaria and will     form the study group. These people will participate in the study for 7 months and will be     checked for the malaria-causing parasite every two weeks by finger prick blood sample.   "
189802|NCT00322348|"     The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to     Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced     breast cancer by assessment of progression-free survival at 24 weeks.      Secondary Objectives are to compare the safety and tolerability profile of ZOLADEX 10.8 mg     and ZOLADEX 3.6 mg by assessment of adverse events (AEs)and to assess goserelin PK in     Japanese and Caucasian participants who have received ZOLADEX 10.8 mg by assessment of     goserelin plasma concentration time profiles      Recruitment into the study has been permanently stopped as of 24 December 2007 due to slow     recruitment. 98 (vs the planned 260) patients were randomised into the study and will be     followed as per protocol for 2 years   "
189803|NCT00322361|"     Hepatitis B Vaccine [Recombinant] is a well-established vaccine which has been used     extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: [1] induce     protection against the morbidity and mortality of acute hepatitis B virus infection, [2]     reduce the incidence of chronic infection in vaccinated populations, and [3] thereby, reduce     the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new     manufacturing process of the Hepatitis B Vaccine [Recombinant] vaccine shows the same level     of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine     [Recombinant] vaccine. This study will also confirm that the new process vaccine is as well     tolerated as the current vaccine.   "
189804|NCT00322374|"     Tumor response information was obtained for all participants who received at least 2 cycles     of study drug, underwent requisite baseline and on-treatment disease assessments and had at     least one post-treatment assessment. Tumor response assessment in evaluable participants was     done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.   "
189805|NCT00322387|"     Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with     chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to     determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if     it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold     before apheresis, and if transplantation with the apheresis product was successful, as     measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).   "
189806|NCT00322400|"     This open-label, dose-finding, multi-center study is designed to determine the safety and the     maximum tolerated dose of AMG 706 given once daily in combination with either weekly     paclitaxel (Arm A) or once-every-3 week docetaxel (Arm B) in subjects with locally recurrent     or metastatic breast cancer. Secondarily, this study will evaluate the pharmacokinetic (PK)     profile of AMG 706 in both treatment arms, the PK profile of paclitaxel in Arm A and the PK     profile of docetaxel in Arm B. Additionally, this study will assess objective tumor response     and duration of response. Exploratory endpoints include the investigation of potential     biomarker development and to assess the effects of genetic variation in drug metabolism     genes, cancer genes and drug target genes on subject response to AMG 706 in combination with     paclitaxel or docetaxel.   "
189822|NCT00322608|"     This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics     of escalating doses of the vascular disrupting agent NPI-2358 in patients with refractory     solid tumors or lymphoma. The formation of new blood vessels (angiogenesis) is an important     component of tumor growth and vascular disrupting agents are intended to target the     differences between these tumor blood vessels and the blood vessels in normal tissues.     NPI-2358 has also been seen to directly affect tumor cells.   "
189807|NCT00322413|"     The two epoetins, Epoetin alfa, a well established drug to treat renal anemia and Epoetin     Omega, that differs from Epoetin alfa in the sugar moiety of the molecule were compared in     regard of efficacy and safety to treat end stage renal disease anemia. Study hypothesis was     that Epoetin Omega is non-inferior to Epoetin alfa in correcting renal anemia in dialysis     patients. A 12-weeks randomized comparative efficacy study was performed including 77 end     stage renal disease patients (epoetin omega:n=39, epoetin alfa: n=38). In the intent-to-treat     analysis, average weekly difference in hemoglobin versus baseline value was higher in     omega-treated patients: 1.94+-0.81 vs. 1.23+-0.62 g/dl. The unadjusted and adjusted     omega-alfa differences were 0.71 g/dl (95%CI 0.38 to 1.04; p<0.001) and 0.78 g/dl (0.49 to     1.08;p<0.001), respectively. Average weekly epoetin dose was lower in the omega group: 87+-25     vs. 108+-21 IU/kg. The unadjusted and adjusted omega-alfa differences were -21IU/kg (-32 to     -11; p<0.001) and -24IU/kg (-35 to -13; p<0.001), respectively. Epoetins were comparably well     tolerated. In dialysis patients, subcutaneous epoetin omega apparently provides a greater     anti-anemic effect per administered dose (IU) than epoetin alfa.   "
189808|NCT00322426|"     The purpose of this study is (1) to determine if patient triggered sensory(auditory, visual     and tactile) cues can help treat freezing of gait in Parkinson's disease, and (2) to assess     if unexpected (randomized) cues are more effective than anticipated ones.   "
189809|NCT00322439|"     This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for     5 years.   "
189810|NCT00322452|"     The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet     chemotherapy given as first line treatment in terms of progression free survival in selected     NSCLC patients with the objective of demonstrating non-inferiority.   "
189811|NCT00322465|"     This study will look at the safety, effectiveness, and tolerability of combination     medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation     of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed     from person to person during sex. This study will compare the 2 currently recommended NGU     treatments, doxycycline and azithromycin, taken with tinidazole (another medication to treat     certain sexually transmitted infections). Tinidazole used with doxycycline or azithromycin     may cure NGU better than when doxycycline or azithromycin is used alone. Study participants     will be 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in     Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Study participation will last     7 weeks and involve 3 visits. At each visit, participants will provide a urine sample, have 2     urethral swabs, and have their urethra checked for discharge indicating infection.   "
189812|NCT00322478|"     Many people with diabetes have a desire to share blood glucose data with other members of     their team. Using a unique wireless glucose meter device, real-time wireless alerts may be     automatically sent to a specific team of interested caregivers whom the patient selects.     Additionally, trending reports can be automatically delivered to any number of authorized     patient caregivers to facilitate more frequent review of glycemic control.      This study is recruiting patients from throughout the USA including Hawaii and Alaska.   "
189833|NCT00322751|"     Given the activity of single-agent Topotecan in NSCLC, there is both scientific rationale and     a medical interest in studying this agent in combination with radiation. In addition,     Topotecan administered on a weekly basis offers advantages over the daily x 5 regimen, i.e.,     the convenience of administration and fewer visits to the clinic.   "
189813|NCT00322491|"     This study evaluates the safety and efficacy of plerixafor given in addition to     granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells     (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and     multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating     CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor     (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN)     engraftment after transplantation. Data from this protocol will assist in the determination     of the dosing schedule for future studies.   "
189814|NCT00322504|"     To assess the efficacy of acupuncture treatment in reducing symptoms of anxiety in women     recently diagnosed with cancer.      • To assess the efficacy of acupuncture treatment on improving perceived quality of life in     women recently diagnosed with cancer.   "
189815|NCT00322517|"     To determine the antitumor efficacy and the safety of SU-014813 at a dose of 100 mg orally     once daily in patients with Metastatic Breast Cancer   "
189816|NCT00322530|"     The goal of the present study is the comparison of different dialysis strategies in     critically ill patients with acute renal failure on the intensive care unit. Patients are     treated with either continuous dialysis or hemofiltration. Outcome measures are death,     restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.   "
189817|NCT00322543|"     Non-randomized, single arm, multi-center, clinical trial evaluating the Corio™     pimecrolimus-eluting stent with reduced anti-platelet therapy in patients with de novo     lesions of the native coronary arteries.   "
189818|NCT00322556|"     The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients     with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety,     the number of infusions temporally associated with AEs, the rate, severity and relationship     of all AEs and the vital sign changes during each infusion will be evaluated.   "
189819|NCT00322569|"     To demonstrate non-inferiority in 6-month angiographic in-stent late lumen loss of the     pimecrolimus-eluting coronary stent (Corio) compared to the CoStar coronary stent control arm     and the dual pimecrolimus/paclitaxel-eluting (Symbio) coronary stent compared to the CoStar     coronary stent control arm for the treatment of single de novo lesions <25 mm in length in     native coronary arteries 2.5 - 3.5 mm in diameter.   "
189820|NCT00322582|"     In many of the patients with cardiomyopathy, the etiology is not clear . In about 30% there     is a family history of cardiomyopathy .Our aim is to study the genetics basis for these     patients with cardiomyopathy with no clear etiology and who have a first degree family     relative with cardiomyopathy as well.   "
189821|NCT00322595|"     The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine     fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in     patients with generalized anxiety disorder (GAD).      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
189825|NCT00322647|"     1. To identify reasons for low patient recruitment numbers to clinical trials in a cancer          research center setting (and a community setting) in order to attempt to increase          accrual rates.        2. To review the screening sheet for women who considered participating in the study of          Tamoxifen and Raloxifene (STAR) for the prevention of breast cancer in high risk women          through the University of New Mexico in Albuquerque from 1999 through 2004   "
189826|NCT00322660|"     Children born after elective C-section have a greater risk of respiratory problems and     hypoglycemia - most likely due to a lower concentration of stress hormones compared to     children born vaginally. Hypothesis: can we eliminate or reduce the risk of respiratory     distress and hypoglycaemia by administrating adrenaline to the newborn.   "
189827|NCT00322673|"     This clinical study is being conducted at multiple sites to determine the activity, safety     and tolerability of XL999 when given weekly to patients with relapsed or newly-diagnosed AML.     XL999 is a small molecule inhibitor against Flk1/kinase insert domain receptor (KDR), PDGFR,     c-Kit, FLT3 and SRC. c-Kit and FLT3 are receptors commonly expressed on AML blasts.   "
189828|NCT00322686|"     The purpose of this study is to determine whether oglemilast is safe and effective in the     treatment of allergen-induced asthma.   "
189829|NCT00322699|"     This protocol is evaluating efficacy and toxicity of three sequential whole bladder     photodynamic treatment with Photofrin and red laser light (630 nm) in the management of     superficial bladder cancer (non-muscle invasive) in those patients who have failed or are not     candidates for conventional intravesical therapy.   "
189830|NCT00322712|"     Chart Review of patients with pancreatic cancer treated with combination of irinotecan,     oxaliplatin and cetuximab.   "
189831|NCT00322725|"     1.11 Retrospectively evaluate for a correlation between tumor response and changes in     systolic/diastolic/mean arterial blood pressures in patients treated with bevacizumab, with     or without chemotherapy, with a wide variety of metastatic malignancies.      1.12 Retrospectively evaluate for differences in tumor response between patients with and     without pre-existing hypertension treated with bevacizumab plus or minus chemotherapy with a     wide variety of metastatic malignancies.      1.21 Determine if there were differences in bevacizumab induced hypertension rates between     different tumor types.      1.22 Evaluate for differences in bevacizumab induced hypertension rates between males and     females.      1.23 Examine if there were associations between a particular chemotherapeutic agent(s), that     may have had an increased propensity of inducing hypertension when combined with bevacizumab.   "
189835|NCT00322777|"     Major depression is a widely spread health problem in Canada. Recent research suggests a     potential role for religion/spirituality in the prevention of and recovery from depression in     adults. The purpose this study was to assess the efficacy of a home-based Spirituality     Teaching Program for adults in the treatment of major depression. The objectives of the study     were to determine:        1. whether the Spirituality Teaching Program is efficacious in improving depression          severity, response rate, and remission rate in adults,        2. whether efficacy is maintained long term (over a 16 week period).   "
189836|NCT00322790|"     Differences in 30-year Trends in Incidence and Survival for Malignant Germ Cell Tumors in     Males and Females.   "
189837|NCT00322803|"     This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients     suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35%     CO2 measured by a visual analogue scale after the first intake and after approximately one     week of treatment as compared to placebo treatment.   "
189838|NCT00322816|"     The purpose of this pilot study is to evaluate the use of (1) 'malaria prevalence', (2)     'malaria incidence' and (3) 'malaria mortality' as a measure of malaria transmission in The     Gambia, while mosquito insecticides (larvicides) are used to control malaria-carrying     mosquitoes. Two thousand children aged 6 months to 10 years of age will be recruited from     villages in the study area. They will be monitored over 7 months for the presence of malaria     parasites and signs and symptoms of the disease.   "
189839|NCT00322829|"     The purpose of this clinical study is to develop an easily performed test to detect Group B     Streptococcus (GBS) in pregnant women at the time of delivery, which would allow health care     providers to make an accurate and rapid decision regarding the administration of antibiotics.     Administering antibiotics during delivery reduces significantly the likelihood of     transmission of GBS, a bacterium that can cause severe life-threatening disease in newborns.     Three hundred and twenty pregnant females between 18 to 44 years of age, who are admitted for     delivery at the time of consent, will be recruited at the Centre Hospitalier Universitaire de     Quebec. Participation involves being observed for 30 minutes. The research nurse will obtain     2 vaginal/anal samples using standard techniques. One sample will be used to detect GBS with     the approved BD GeneOhm StrepB assay and the other sample will be used for the development of     the new point-of-care rapid detection GBS test.   "
189840|NCT00322842|"     This study evaluates the safety of plerixafor and other outcomes that are purely exploratory     in nature. One other pre-specified outcome is to evaluate an interval of 10-11 hours between     dosing with plerixafor and the beginning of apheresis to determine if there will be at least     a 2-fold increase in circulating CD34+ cells. Data from this protocol will assist in the     determination of the dosing schedule for future studies.   "
189841|NCT00322855|"     To review the outcome of patients with soft tissue sarcoma treated with chemotherapy from     2004 and 2005.   "
189842|NCT00322868|"     Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease.      Markers of inflammation (neutrophils, elastase, cytokines and bacteria)will be measured in     induced sputum specimens before and after a 4 week treatment period with pioglitazone in     clinically stable CF patients.   "
189843|NCT00322881|"     The main purpose of this trial is to look at how elderly women (70 years of age or older)     with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of     carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or     responds to standard carboplatin and paclitaxel chemotherapy.   "
189901|NCT00323648|"     Each patient is preoperatively treated once profylactic with intraveneous antibiotics.     Postoperatively, one group will be treated with intraveneous antibiotics during 5 days. The     other group will receive no antibiotics.   "
189844|NCT00322894|"     The Expanded Breast Cancer Registry and Tissue Repository Research Team (EBCR-RT) is     comprised of University of Mexico Comprehensive Cancer Center faculty and staff whose goals     are to improve the outcomes and quality of life of patients with breast cancer, and     ultimately to eradicate and cure breast cancer. One focus of the EBCR-RT is the creation an     infrastructure that can potentially be adopted as a model for a statewide registry and tissue     repository for the discovery of biomarkers for this disease.      The goals of the EBCR are:        1. To register patients diagnosed with breast cancer and information relevant to their          diagnosis (such as stage, grade, hormone receptor status, etc), treatment (surgery,          radiation, chemotherapy, hormone therapy, etc), and survivorship (Quallity of Life,          etc).        2. To collect relevant demographics including age, menopausal status, race/ethnicity, body          mass index (BMI), place of residence, behaviors (smoking, alcohol intake, etc)        3. To establish a paired tumor tissue and blood sample for each relevant time-point (as          defined in the protocol), which will be stored in the Tissue Bank Shared Resource          Facility for future hypothesis-driven research.   "
189845|NCT00322907|"     The purpose of this study was to assess the safety and efficacy of Cotrifazid to treat     uncomplicated resistant malaria and to compare the outcome with mefloquine or     quinine+sulfadoxine/pyrimethamine (SP)   "
189846|NCT00322920|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of topotecan when     given weekly with cisplatin in patients with persistent, recurrent, or advanced stage     cervical cancer. Secondary purposes are to describe the toxicity profile in patients with     persistent, recurrent, or advanced stage cervical cancer treated with the combination of     topotecan when given weekly with cisplatin and to determine the response rate and time to     progression in patients with persistent, recurrent, or advanced stage cervical cancer treated     with the combination of topotecan when given weekly with cisplatin.   "
189847|NCT00322933|"     This multicentre SHARF4 (Stuivenberg Hospital Acute Renal Failure) study aims to investigate     outcome in patients with acute renal failure (ARF), stratified according to severity of     disease (SHARF score) and randomised to different treatment options.      All adult patients with a serum creatinine >2 mg/dl were included. Patients were stratified     according to disease severity and those in need for RRT were randomised to intermittent     (IRRT) or continuous renal replacement therapy (CRRT)   "
189848|NCT00322946|"     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and     subtropical regions of the world. The purpose of this study is to evaluate the safety and     immune response to the dengue vaccine DEN4delta30-4995 in healthy adults.   "
189894|NCT00323557|"     The goal of this clinical research study is to see if Leukine(R) (sargramostim) improves the     effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia,     in patients with chronic lymphocytic leukemia (CLL).   "
189849|NCT00322959|"     Tai-Chi-Chuan (TCC), a branch of traditional Chinese martial arts, has been widely practiced     since the 17th century. Recent studies have shown that TCC can improve cardiorespiratory     function, muscle strength, humoral and cellular immunity, metabolic response and mental     control.      Cultured monocytes from blood or bone marrow can be triggered to differentiate to myeloid     dendritic cells (DC). DCs are specialized leukocytes for presenting antigens to quiescent,     naive, and memory T cells, and they play pivotal roles in the induction of cell-mediated as     well as humoral immune responses in vivo. Mature DCs have a capacity for initiating immunity     or tolerance, which depends on their activation state.      In this study we will investigate the effect of TCC on DC differentiation in the peripheral     blood obtained from the healthy donors who take part with and without TCC exercise. The     distribution of various DC sub-populations (myeloid DC and plasmacytoid cell) will be     analyzed by detecting surface marker expression.   "
189850|NCT00322972|"     The WHO has initiated a program to eliminate trachoma, blinding eye infection caused by     Chlamydia trachomatis, in large part by mass distributions of oral azithromycin. The proposed     study will determine the frequency and treatment target of community-wide mass antibiotic     treatment. We will also study the impact of mass antibiotic distribution on     antibiotic-resistance in pneumococcus.   "
189851|NCT00322985|"     T-cell Non-Hodgkin's lymphomas are a group of cancers that are usually treated with     chemotherapy, radiation therapy, or occasionally surgery. T-cell lymphomas are relatively     uncommon and therefore not well studied. Treatment approaches are patterned after the more     common B-cell lymphomas. T-cell lymphomas are more likely to relapse following standard     therapy than are B-cell lymphomas. New therapies are needed for T-cell lymphomas. In this     study, we will administer the drug called lenalidomide as a pill to patients with T-cell     lymphoma. The goals are to determine if the drug can induce regression of the cancer, and to     determine if the treatment is well tolerated in this patient group. This study will take     place at six cancer centres across Canada.   "
189852|NCT00323011|"     This study is for people with colorectal cancer, who have tumors that cannot be completely     removed by surgery. Blood clots are a problem in patients with cancer. Blood clots are also a     problem in patients receiving cancer drugs. Studies have shown that up to 17% of patients     receiving cancer drugs experienced blood-clotting problems. One purpose of this study is to     find if the drug combination of irinotecan, 5-fluorouracil (5-FU), bevacizumab and leucovorin     (LV) affect blood-clotting factors. A second purpose of this study is to find out what     effects the drug dalteparin has on clotting factors in the blood in patients receiving the     drug combination of irinotecan, 5-FU, bevacizumab and LV. It is hoped that adding dalteparin     to chemotherapy may benefit patients with colorectal cancer by preventing blood clots   "
189853|NCT00323024|"     The purpose of this study is to determine the safety and maximum tolerated dose of inhaled     NX1011 for the treatment of pulmonary arterial hypertension (PAH).   "
189854|NCT00323037|"     The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in     improving heart function in subjects with stable chronic heart failure.   "
189855|NCT00323050|"     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a     booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14     months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix     hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.   "
189902|NCT00323661|"     The purpose of this study is to compare the influence of accelerometer-based rate adaptation     and Closed Loop Stimulation on cognitive performance and quality of life in pacemaker     patients.   "
189856|NCT00323063|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor     cells.      PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see     how well they work compared to gemcitabine alone in treating patients with previously treated     locally advanced or metastatic breast cancer.   "
189857|NCT00323076|"     Positron Emission Tomography (PET) is a Nuclear Medicine procedure that uses positron     emitting radiolabeled tracer molecules to visualize biological activity. The presence of     hypoxia (low oxygen) is associated with poor prognosis in a variety of tumour types and     treatment strategies targeting hypoxic cells have been developed. The PET tracer [18]F-FAZA     can identify hypoxic areas, and changes in uptake during treatment may predict tumour     response.   "
189858|NCT00323089|"     The objective of this study is to determine if subcentimetre pulmonary nodules can be     accurately and safely excised by endoscopic stapling devices after they have been localized     using CT and marked with a microcoil device.      The addition of real-time CT imaging and insertion of platinum microcoil markers to the     technique of video assisted thoracoscopic stapled resection of subcentimetre pulmonary     nodules, will decrease the rate of open thoracotomies required to completely resect the     nodules.   "
189859|NCT00323102|"     This study aims at a direct comparison between Multihance and a validated comparator like     Omniscan in a cross-over individual design in patients with brain tumors to confirm the     superior overall diagnostic performance of MuliHance for this indication   "
189860|NCT00323115|"     Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme will be     treated with radiotherapy/chemotherapy followed by dendritic cell vaccine. Chemotherapy will     be administered after three vaccinations for one year or until progression of disease.   "
189861|NCT00323128|"     This study has an open study design. The GFR will be measured using the renal clearance of     inulin (Inutest) in volunteers with different stage of renal disease or without renal     disease. A blood sample will be obtained for measuring serum creatinine in different     laboratories.   "
189862|NCT00323141|"     To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro     II prothesis in patients with a hernia umbilicalis.   "
189889|NCT00323492|"     This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected     patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing     highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose     combination tablet of emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg [FTC/TDF]).     Subjects continued their nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease     inhibitor (PI) at the same dose.   "
189890|NCT00323505|"     Multiple myeloma is a rare form of malignancy in which neoplastic plasma cells accumulate in     the bone marrow. Most malignant plasma cells continue to produce immunoglobulin. The activity     of multiple myeloma can therefore usually be monitored easily by serial measurement of the     serum paraprotein levels. Except for a few patients who receive a donor bone marrow     transplant, multiple myeloma remains incurable despite intensive chemotherapy. Its course is     typically marked by periods of active disease alternating with increasingly shorter     remissions.      Interferons are substances produced in human cells in response to a variety of stimuli, such     as viral infection. When given to myeloma patients as part of maintenance treatment ,     interferon-alpha 2 b (INTRONA) has been shown to be of value in prolonging the periods of     remission. Until now, INTRONA could only be given as injections under the skin, three times     a week. Some patients experience flu-like symptoms with each injection, particularly early on     during maintenance therapy. This, as well as the chronic fatigue and even depression that     INTRONA can induce may considerably reduce the quality of life of myeloma patients on     interferon, so much so that sometimes this useful adjunct to chemotherapy for myeloma has to     be stopped.      Recently, a new preparation of interferon namely pegylated interferon (PEG Intron) has become     available. It has the advantage of being broken down much more slowly by the body and     therefore only needs to be given once a week. This minimises the swings in blood interferon     levels that may be responsible for some of the interferon side effects. The safety and     superior tolerability of PEG Intron has already been demonstrated in patients with hepatitis     C for which it now carries a licence, but not in myeloma patients. Here, we propose to study     whether the quality of life and side effect profile of myeloma patients on PEG Intron is     better compared to that of Intron®A.      In the main study, consenting eligible myeloma patients who are well and have been     established on INTRONA maintenance therapy for at least six weeks will be randomly allocated     to receive PEG Intron for three months followed by INTRONA for 3 months, or to continue with     INTRONA for 3 months followed by PEG Intron for 3 months. All patients will be monitored     regularly for any side effects and will be asked to fill in a quality of life questionnaire     at the beginning (i.e. before receiving the first randomised treatment) and at the end of     each study period (i.e. at 3 and 6 months). Initially, we are aiming at enrolling 60 patients     into this part of the study.      In a smaller sub-study involving only 14 patients initially, we are proposing to investigate     whether myeloma patients who need to be taken off Intron®A because of its side effects can     tolerate PEG Intron more easily. Should their tolerance of PEG Intron also be poor we would     stop the interferon maintenance therapy altogether. However, should PEG Intron be found to be     acceptable to them, we intend to switch these patients back to the standard treatment at the     end of six weeks treatment with PEG Intron to assess whether they have become more tolerant     of Intron®A in the intervening period. Patients will again be monitored carefully for any     side effects and will be asked to fill in three quality of life questionnaires (at 0, 6 and     12 weeks).   "
189863|NCT00323154|"     Itching is a frequent and disturbing side effect of the use of pain medication such as     morphine. In the post-operative period, it can be more distressing to pediatric patients than     their pain. The current first line treatment, an antihistamine (Benadryl), has a low     efficacy. This treatment causes sleepiness and may be dangerous when used in combination with     other drugs.      Nalbuphine has analgesic properties similar to morphine as well as the ability to reverse     some morphine-induced side effects, such as respiratory depression and itching. Nalbuphine     has been used effectively for patients undergoing Caesarean sections. However, the     effectiveness of nalbuphine in the pediatric population has not been investigated.      We want to determine the efficacy of nalbuphine in the treatment of itching after morphine     for postoperative pain relief. We will use a novel method to measure the effect of the     treatment using an intensity scale before and after the drug, to determine the intensity     difference.   "
189864|NCT00323167|"     Mucociliary clearance, in which mucus secretions are cleared from the breathing airways, is     the primary defense mechanism for the lungs. Inhaled particles, including microbes that can     cause infections, are normally entrapped in mucus on the airway surfaces and then cleared out     by the coordinated action of tiny hair-like structures called cilia. Individuals with primary     ciliary dyskinesia, variant cystic fibrosis, and pseudohypoaldosteronism have defective     mucociliary clearance. The purpose of this study is to collect clinical and genetic     information about these three airway diseases to improve current diagnostic procedures.   "
189865|NCT00323180|"     This study is looking at biomarkers in prostate cancer.   "
189866|NCT00323193|"     This study involves a controlled trial of an optimized version of a weight management and     physical activity psycho-educational intervention (called MOVE!) with 200 obese and     overweight veterans with serious mental illness.   "
189867|NCT00323206|"     The purpose of this research study is to study a type of gene therapy treatment called     plasmid electroporation. This type of treatment involves the injection of a gene into some     melanoma tumors located near the surface of the skin, followed by a burst of electricity into     the tumor to cause the tumor to take up the gene. This study is a Phase I study to determine     the side effects and the correct dose of this type of treatment and also its effectiveness in     treating melanoma. While the electroporation technique has been used in people, the     combination of plasmid injection and electroporation is being tried in human beings for the     first time.   "
189868|NCT00323219|"     Patients often come to the emergency department with bacterial skin infections (known as     cellulitis). Some patients with very severe infections are admitted to hospital for     antibiotic treatment and some are sent home on oral antibiotics. Many patients have moderate     infections and are treated as outpatients with daily intravenous antibiotics for 2-5 days. In     this patient group it is unclear if treatment with oral antibiotics is as effective as     intravenous antibiotics. The purpose of this study is to determine if treatment of moderate     cellulitis with an intravenous antibiotic (cefazolin) for 3-5 days is as effective as     treatment with an oral antibiotic (moxifloxacin). We hypothesize that the oral agent will be     as effective as intravenous treatment for moderate cellulitis.   "
189903|NCT00323674|"     This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a     minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open     surgery according to modified Lichtenstein procedure with light weight mesh.   "
189869|NCT00323232|"     Although Standard of Care for Hip Fractures is the Device (Dynamic Hip Screw) being studied     in this project, and both sizes (the 2 and the 4 hole versions) are currently in use there is     not widespread agreement yet whether there is an optimal number of screws (2 or 4) required     for the best outcomes. If it can be shown that a 2 hole version is just as successful in     outcomes it would allow for a smaller incision (surgical cut) at the site of the fracture.     This could reduce soft tissue dissection, operating time, and surgical blood loss. This in     turn would reduce post operative pain, blood loss, and hospital length of stay.   "
189870|NCT00323245|"     Conservative management for urinary incontinence has been shown to improve bladder control.     We are conducting a study of the effectiveness of conservative management for urinary     incontinence in women who also have osteoporosis. We hope to find that treatment for     incontinence improves bladder control and thereby allows women to be more active and reduces     their risk of falling and breaking bones.   "
189871|NCT00323258|"     The purpose of this study is to evaluate the effectiveness of a program to help patients with     heart disease stay on their heart medications.   "
189872|NCT00323271|"     The purpose of this study is to evaluate the efficacy of a brief psychological intervention,     cognitive-behavior therapy, for the management of persistent pain associated with Multiple     Sclerosis.   "
189873|NCT00323284|"     The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular     micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle     glaucoma or ocular hypertension and co-existing cataract.   "
189874|NCT00323297|"     To assess the efficacy and safety of sildenafil when added to patients with PAH who are     taking bosentan as all or part of their background therapy.   "
189875|NCT00323310|"     The purpose of this study was to assess the safety and enhancing properties of the magnetic     resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having     central nervous system (CNS) disorders.   "
189876|NCT00323323|"     Purpose: This study will evaluate the safety of CHOP plus Alemtuzumab in patients with T/NK     cell lymphomas and CD-20 negative large B-cell lymphomas who have not had previous     treatments. The biological response of lymphoma cells and the immune system to this drug     combination will also be measured in patients before, during, and after therapy     administration.   "
189877|NCT00323336|"     Study is being done to determine if it is possible to use saliva to measure bone specific     proteins and predict bone turnover which could be used in the treatment of osteoporosis.   "
189891|NCT00323518|"     CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein,     is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly     occurring side effect of high-dose chemotherapy in patients undergoing autologous     hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the     safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients     at risk for developing oral mucositis.   "
189892|NCT00323531|"     The null hypothesis is that patients receiving either thoracoscopy or fibrinolysis for     empyema recover in the same amount of time. Therefore, we will test this by randomizing the     next 40 patients who consent to the study to one treatment or the other.   "
189878|NCT00323349|"     Diabetes mellitus (DM) type 2 is well recognized as a major cause of morbidity and mortality     in the United States, as well as a significant contributor to health disparities within the     population. Changes in demographic and lifestyle characteristics in the population have led     to a progressive increase in the prevalence of both diabetes and impaired glucose tolerance     (IGT), a precursor to DM type 2. Although pharmacologic interventions have proven to be     successful in blocking the progression from IGT to DM, they have not been as effective as     diet and exercise modification. Studies of behavioral interventions in IGT have focused on     the outcomes of improved DM risk factors and decreased progression to DM, but have either     required extensive interventions that lack applicability to the general population or have     utilized more modest interventions with no effect on risk factors. These studies have not     included impact evaluations to assess the effect of knowledge of IGT status on motivation to     change and perceived risk. This study will assess the impact of knowledge of IGT on the     likelihood of altering health-related behaviors, utilizing the Health Belief Model as a     conceptual framework. Subjects will be randomized to one of four treatment arms, organized in     a factorial design to (1) assess the impact of OGTT testing on motivation to change behaviors     and (2) evaluate the efficacy of a novel educational intervention linked to patients'     learning styles. This evaluation will determine whether OGTT testing is more beneficial as a     cue to action to motivate behavior change than a multifactorial assessment of diabetes risk.     Additionally, the improvement in health motivation after an educational intervention is     expected to be enhanced when the educational method is tailored to the individual's preferred     learning style. This information will provide the foundation for more efficient behavioral     interventions for patients at high risk for DM type 2.   "
189879|NCT00323362|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib     mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer.   "
189880|NCT00323375|"     The purpose of this protocol is to perform Phase 1 (safety/toxicity and pharmacokinetic)     Studies of an investigational aminoquinoline antimalarial (AQ-13) in human subjects. The     compound to be studied (AQ-13) is being examined because it is active in vitro against     Plasmodium falciparum malaria parasites resistant to chloroquine (CQ) and other antimalarials     (multi-resistant P. falciparum), and because its safety was similar to that of CQ in     preclinical studies performed by SRI International (IND 55,670). AQ-13 was also selected for     study because it is active in vivo in two monkey models of human malaria: 1] P. cynomolgi in     the rhesus monkey (Macaca mulatta), a model of human infection with P. vivax, and 2]     CQ-resistant P. falciparum in the squirrel monkey, a model of human infection with     CQ-resistant P. falciparum.   "
189881|NCT00323388|"     Identification of Risk Allels for Prostate Cancer   "
189882|NCT00323401|"     1. To study the influence of antenatal classes for first time parents and their effect ob          pregnancy, birth and parenthood.        2. Randomized into two groups (a. 3 courses in midpregnancy and b. no courses)        3. Data on pregnancy, birth and parenthood are collected from register and questionaire   "
189904|NCT00323687|"     There is an unmet medical need for potent ART regimens that make adherence to treatment even     easier due to QD dosing, offer a good tolerability profile and fit into the daily life of     patients.   "
190711|NCT00345800|"     To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus     on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine     changes.   "
189883|NCT00323414|"     Non-alcoholic steatohepatitis (NASH), the most severe form of liver injury in the spectrum of     non-alcoholic fatty liver disease (NAFLD), has emerged as the major cause of chronic liver     disease in developed countries. Among adults in the United States, the prevalence is between     5.7% and 17%. These rates are expected to increase concurrent with the epidemics of obesity     and type 2 diabetes mellitus, which are the major risk factors for NAFLD and NASH. In     addition to its high prevalence, NASH is also a progressive fibrotic disease that advances to     cirrhosis and liver related death in 20% and 12% of patients, respectively. Among NASH     patients with cirrhosis, 40% have liver related death. Diabetics are particularly prone to     experience these poor outcomes. No therapy has been proven effective for patients with NASH.      The purpose of this study is to find out whether treatment with polyunsaturated fatty acids     (eicosapentaenoic acid [EPA] combined with docosahexaenoic acid [DHA] called Opti-EPA)     improves NASH compared to treatment with placebo pills. The placebo pills will contain corn     oil and will be contained in a capsule, but have no medical effect on the body. The     investigators will determine improvement in NASH from microscopic changes in the subject's     liver tissue during 48 weeks of treatment. This means that the subject will need to have a     liver biopsy before and after the treatment.      Omega-3 fatty acids are a form of polyunsaturated fats, one of the four basic types of fat     that the body gets from food. (Cholesterol, saturated fat, and monounsaturated fat are the     others.) One's body does not make this type of fat; it comes from food sources. These fats     are found in foods like cold water fish (tuna, salmon, and mackerel), and vegetable products     like flaxseed oil and walnuts.      Research shows that polyunsaturated fats are good for people. Studies have shown that it is     good for heart health by playing a role in keeping blood cholesterol levels low, keeping     irregular heart rhythms stable, and reducing blood pressure.      The drug being studied, Opti-EPA, is a nutritional supplement. They do not have to be     reviewed by the Food and Drug Administration (FDA) like medicines do. Opti-EPA is considered     experimental in this study. This means that the United States Food and Drug Administration     (FDA) has not approved it for use in people with nonalcoholic fatty liver disease.   "
189884|NCT00323427|"     This study evaluates whether a 2 hour group session, The Living Well with Hearing Loss     Workshop, can successfully teach hard of hearing people how to best use hearing aids and a     variety of personal skills to compensate for the limitations of their impaired ears.   "
189885|NCT00323440|"     Familial Mediterranean fever (FMF) is a genetic disease, caused by mutations in the FMF gene,     entitled MEFV. The disease is characterized by painful attacks of inflammation in sites lined     by serous membranes (e.g. abdominal pain caused by inflammation of the peritoneum, a serous     membrane surrounding all internal organs within the abdomen). Continuous colchicine treatment     prevents attacks in most patients. The pathogenesis of the disease, what leads to the attacks     and how colchicine helps, are questions not yet resolved. Elucidating the role of the     inflammatory proteins is an important step towards the understanding of these questions. To     date only small numbers of cytokines and inflammatory proteins have been studied     individually. We propose to study a large number of these proteins in the RNA and protein     levels addressing the interaction between them and the effect of colchicine on their     expression.      Blood samples will be drawn from consenting patients in remission, during attacks, under and     without colchicine treatment. (20 patients in each category).Twenty healthy volunteers will     donate control blood samples for the study. RNA will be produced from the neutrophils, and     cytokines and various proteins' RNA expression will be determined. Major expressed proteins     will be measured in the same samples and the results will be analyzed with regard to the     activity of the disease, MEFV mutations and colchicine treatment status. The information     obtained by the study may allow us to determine the sequence of events associated with FMF     attack development, and perhaps take us one step further in the understanding of the     pathogenesis of the disease.   "
189886|NCT00323453|"     The purpose of this study is to determine whether the incidence of surgical site wound     infection will be reduced in open appendectomy patients through the use of the Alexis® wound     retractor.   "
189887|NCT00323466|"     Study to investigate the effect of two types of radiotherapy on saliva: IMRT versus     conventional radiotherapy.      In each group, one part will receive normal dental preventive treatment. The other part will     use products for treatment of dry mouth (Biotene gamma).      Both anorganic and organic components of the saliva will be studied at different time points,     combined with bacterial swabs.   "
189895|NCT00323570|"     This trial is conducted in the United States of America (USA). The purpose of this study is     to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to     Trauma      Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged.   "
189896|NCT00323583|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, oxaliplatin, leucovorin and     5-fluoruracil, work in different ways separately and in combination to stop tumor cells from     dividing so they stop growing or die. The use of metronomic dosing of chemotherapy minimizes     side effects and increases efficacy by anti-angiogenic effects. The pilot study demonstrated     promising responses in all patients. It is not yet known how effective this drug and dosing     combination is in treating advanced pancreatic cancer.      PURPOSE: This non-randomized phase II trial is studying giving weekly doses of paclitaxel,     oxaliplatin, leucovorin and 5-fluorouracil together as second or third-line therapy in     treating patient with locally advanced unresectable or metastatic adenocarcinoma of the     pancreas following demonstrated progression after first-line gemcitabine.   "
189897|NCT00323596|"     Action Seniors!: A 12-Month Randomized Controlled Trial of a Home Based Strength and Balance     Retraining Program in Reducing Falls Risk Factors   "
189898|NCT00323609|"     Patients with osteoporotic vertebral body compression fractures will be randomly assigned to     treatment with balloon kyphoplasty or vertebroplasty. Over 2 years of follow-up, back pain,     back function, quality of life, adverse events, subsequent fractures and cumulative     healthcare costs will be compared.   "
189899|NCT00323622|"     The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium     falciparum (P. falciparum) malaria vaccine is being developed for the routine immunization of     infants and children living in malaria endemic areas. The vaccine would offer protection     against malaria disease due to the parasite P. falciparum. The vaccine would also provide     protection against infection with hepatitis B virus (HBV).      This phase IIb trial is being carried out following the demonstration of efficacy of the     candidate malaria vaccine in children in Mozambique: there, the vaccine demonstrated     approximately 30% efficacy against clinical episodes of malaria and approximately 58%     efficacy against severe malaria disease.      In this study, the children from Mozambique (NCT= NCT00197041) are followed-up to assess the     safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period     commencing 21 months after Dose 1.      This protocol posting deals with objectives & outcome measures of the extension phase at year     2. During this extension study, no new subjects will be recruited and no vaccine will be     administered.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
189905|NCT00323700|"     To determine if there is a clinically and statistically significant difference between     OROS-MPH and IR MPH in ADHA and ODD symptoms by the parent completed SNAP-IV. It is     hypothesized that OROS-MPH is superior in improving symptom outcomes overall, remission rate,     functional improvement, quality of life and persistence with medication over time.   "
189906|NCT00323713|"     The purpose of this study is to determine whether the use of a very low protein diet is     effective in delaying the start of chronic dialysis treatment in patients affected by chronic     kidney disease (CKD).   "
189907|NCT00323726|"     Trends in Incidence and Survivals for Ovarian Germ Cell Tumors: A 27-Year Population-Based     Study   "
189908|NCT00323739|"     This phase II trial will evaluate the combination of bevacizumab + RAD001 in patients with     metastatic renal cell carcinoma. In this trial the investigators will evaluate this     combination in patients previously untreated with any anti-angiogenesis agent and patients     who have previously received one prior regimen containing an anti-angiogenesis agent.   "
189909|NCT00324831|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine,     and prednisone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can     block cancer growth in different ways. Some block the ability of cancer cells to grow and     spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells     found in bone marrow or peripheral blood and may help the immune system recover from the side     effects of chemotherapy. Vaccines made from a person's cancer cells may help the body build     an effective immune response to kill cancer cells. It is not yet known whether giving GM-CSF     together with vaccine therapy is more effective than giving GM-CSF together with a placebo     when given after combination chemotherapy and rituximab in treating diffuse large B-cell     lymphoma.      PURPOSE: This randomized phase III trial is studying GM-CSF and vaccine therapy to see how     well they work compared to GM-CSF and placebo when given after combination chemotherapy and     rituximab as first-line therapy in treating patients with stage II, stage III, or stage IV     diffuse large B-cell lymphoma.   "
189910|NCT00324857|"     The purpose of this study is to demonstrate the efficacy of interventions to improve     understanding of knee replacement risks, benefits, and expected outcomes among AA primary     care patients, increase willingness to consider knee replacement among AA primary care     patients, and increase primary care referral rates for surgical consideration for AA patients     who meet the indications for knee replacement.   "
189911|NCT00324870|"     This phase I/II trial is studying the side effects and best dose of vorinostat when given     together with bevacizumab and to see how well they work in treating patients with     unresectable or metastatic kidney cancer. Vorinostat may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood     flow to the tumor. Giving vorinostat together with bevacizumab may kill more tumor cells.   "
189912|NCT00324883|"     We plan to assess the accuracy of a new means of estimating urine sodium excretion. We will     compare the chloride to creatinine ratio obtained by titrator sticks with urine sodium     measured by a standard laboratory. If found to approximate sodium excretion, the titrator     sticks could provide a convenient means for doctors and patients to monitor their salt     intake.   "
189913|NCT00324896|"     Parkinson's disease (PD) is the second most common neurodegenerative disease in the US,     affecting nearly 1 million Americans. Up to 82% of community dwelling individuals with PD     complain of sleep disturbances, typically sleep fragmentation. Despite the high prevalence of     sleep problems and their impact on the life of these individuals, there has been, until     recently, little research focus on the problem. This will be a multi-site, double blind,     placebo-controlled, two arm, parallel group, fixed-dose trial which will last 6 weeks.     Seventy patients at four sites (30 at the PI's site and a total of 40 patients at three     external sites) will be equally randomized to eszopiclone or placebo. The primary hypothesis     is that eszopiclone will be superior to placebo for the treatment of insomnia in patients     with Parkinson's disease   "
189914|NCT00324909|"     Autism is a neurodevelopmental disorder that currently affects as many as 1 out of 166     children in the United States. Autism is considered by many to be a permanent condition with     little hope for improvement. Treatment for autism is centered on special schooling and     behavioral therapy; medical science currently has little to offer.      Recent research has discovered that some autistic individuals have decreased blood flow to     the brain, evidence of inflammation in the brain, and increased markers of oxidative stress.     Multiple independent single photon emission computed tomography (SPECT) and positron emission     tomography (PET) research studies have revealed hypoperfusion to several areas of the     autistic brain, most notably the temporal regions and areas specifically related to language     comprehension and auditory processing. Several studies show that diminished blood flow to     these areas correlates with many of the clinical features associated with autism including     repetitive, self-stimulatory and stereotypical behaviors, and impairments in communication,     sensory perception, and social interaction. Hyperbaric oxygen therapy (HBOT) has been used     with clinical success in several cerebral hypoperfusion syndromes including cerebral palsy,     fetal alcohol syndrome, closed head injury, and stroke. HBOT can compensate for decreased     blood flow by increasing the oxygen content of plasma and body tissues and can even normalize     oxygen levels in ischemic tissue. In addition, animal studies have shown that HBOT has potent     anti-inflammatory effects and reduces oxidative stress. Furthermore, recent evidence     demonstrates that HBOT mobilizes stem cells from human bone marrow which may aid recovery in     neurodegenerative diseases. Based upon these findings, it is hypothesized that HBOT will     improve symptoms in autistic individuals.      The purpose of this study is to determine if HBOT improves clinical outcomes in children with     autism. The study will also determine if HBOT changes markers of inflammation and oxidative     stress in autistic children.   "
189915|NCT00324922|"     The primary question of this study is to understand if trimethoprim-sulfamethoxazole     (TMP-SMX) is as effective as vancomycin for treating methicillin-resistant Staphylococcus     aureus (MRSA) osteomyelitis.   "
189916|NCT00324948|"     Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria     will be enrolled and randomized to receive either active drug or matching placebo. After a     two-month, non-treatment period, patients will receive study drug for 6 months and will     record information about sexual encounters in a daily diary. Study drug will be applied     directly to the genital area 30-60 minutes before initiation of sexual activity. The endpoint     of the study is based on the use of a standard measure of sexual function (FSEP).   "
189919|NCT00324987|"     This randomized phase III trial studies imatinib mesylate and bevacizumab to see how well     they work compared to imatinib mesylate alone in treating patients with gastrointestinal     stromal tumor that has spread to other parts of the body or cannot be removed by surgery.     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability     of tumor cells to grow and spread. It is not yet known whether imatinib mesylate and     bevacizumab are more effective than imatinib mesylate alone in treating gastrointestinal     stromal tumor.   "
189920|NCT00325000|"     We examined the hypotheses that severely depressed inpatients treated for 5 weeks with IPT-S     plus pharmacotherapy have 1) a higher reduction in depressive symptoms and 2) higher     response- and remission rates compared to pharmacotherapy plus CM. For the follow-up period     (12 months) we hypothesized a better symptomatic and psychosocial longterm outcome and lower     rates of relapse for patients initially treated with combination therapy.   "
189921|NCT00325013|"     The researches aim to study the effects of DHA (component of fish oil) on patients with     Primary Sclerosing Cholangitis (PSC). Our hypothesis is that DHA might reverse the problems     associated with PSC.   "
189922|NCT00325026|"     The purpose of this study is to compare the time to delivery of two different cervical     ripening methods on the preterm gestation.   "
189923|NCT00325039|"     The primary aim of this clinical trial is to compare treatment success for two minimally     invasive surgical procedures to treat stress urinary incontinence in women. These procedures     are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes     for the two surgical procedures, including quality of life, sexual function, satisfaction     with treatment outcomes, complications, and the need for other treatments(s) after surgery.     Follow-up will be a minimum of two years.   "
189932|NCT00325169|"     This study was designed to evaluate the effects on lung function of a combination of SERETIDE     50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual     treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily     alone) in subjects with COPD. The study will utilise a three-way cross-over design with a     2-week wash-out period between each 2-week consecutive treatment period.   "
189924|NCT00325065|"     The goal of this protocol, broadly stated, is to use targeted manipulations with intranasally     administered oxytocin (OT) and arginine vasopressin (AVP) in conjunction with neurocognitive     and neuroimaging paradigms to evaluate claims that OT and AVP inhibit and facilitate,     respectively, the effective processing of aversive signals. Moreover, we wish to examine     whether increased vasopressin levels will increase, and increased oxytocin levels decrease,     the neural response in the amygdala and other limbic structures to aversive stimuli. In     addition, we wish to assess whether OT and AVP administration will lead to the facilitation     of conspecific recognition as appears to be the case for other mammalian species....   "
189925|NCT00325078|"     This study will determine if the drug infliximab is safe for treating inflammatory bowel     disease (IBD) in patients with chronic granulomatous disease (CGD). IBD is an inflammation or     irritation of the gut that leads to symptoms such as diarrhea, bloating and stomach cramps.     CGD is an inherited disease affecting white blood cells called neutrophils in which patients     are susceptible to repeated bacterial and fungal infections. They also have a higher     incidence of some autoimmune diseases, such as IBD. Infliximab is approved to treat Crohn's     disease, an IBD similar to that seen in patients with CGD.      Patients 10 years of age and older with CGD and IBD may be eligible for this study.     Candidates are screened with a medical history, physical examination, blood and urine tests,     electrocardiogram (EKG), tuberculosis skin test (PPD skin testing), and stool test for the     presence of infections. Additional tests may be done, including colonoscopy (procedure using     a flexible tube through the rectum to examine the lining of the gut) and imaging studies such     as an x-ray, chest CT scan (test using a special x-ray machine), MRI (test using a magnetic     field and radio waves), and barium studies (study using a drinkable solution of barium to     help enhance the x-ray pictures of the gut).      Participants are divided into patients with IBD symptoms (Group 1) and patients without IBD     symptoms (Group 2) for the following procedures:      Group 1      Patients are evaluated every 6 months with a medical history and physical examination for     signs and symptoms of IBD. Patients who are taking moderate to high doses of steroid     medications have their medication slowly lowered (tapered) and are evaluated every 3 months     for a total of 2 years. Patients in this group who start to develop IBD symptoms are moved to     Group 2 for treatment with infliximab (see below).      Group 2      Patients in Group 2 receive infliximab infusions at 2-week intervals for three doses. The     drug is given over a 2-hour period through a catheter placed in a vein. Patients are     evaluated with a medical history, physical exam, and blood tests the day of each dose. One     week after the last dose, they have another evaluation, including a colonoscopy. Patients who     respond well to infliximab may continue to receive the drug every 2 months for a total of 1     year, with evaluations at every dosing visit. At the end of the first year of receiving     infliximab, all patients have follow-up evaluations every 6 months for a total of 2 years.      Group 3      Subjects who volunteer to undergo colonoscopy and research biopsies that serve as controls     for evaluation of the patient gut samples.   "
189926|NCT00325091|"     This study will examine the effects of long-term practice of repeated finger movements in     people with focal hand dystonia, as compared with healthy volunteers. Patients with dystonia     have muscle spasms that cause abnormal postures while trying to perform a movement. In focal     dystonia, just one part of the body, such as the hand, neck or face, is involved.      Right-handed healthy volunteers and patients with focal hand dystonia of the right hand 18     years of age and older may be eligible for this study. Candidates are screened with a medical     history and neurological and physical examination.      Participants are trained daily for 11 days (excluding weekends) at the NIH and are asked to     continue with daily 15 minutes of practice over a 12-week period to perform sequential finger     movement task (key presses) with their left hand. They practice initially at NIH and then at     home. At each clinic visit, their learning of the motor skill is assessed by recording their     performance of 20 consecutive trials of the eight sequences (a total of 160 key presses) in     the task.      To evaluate long-term motor learning of the sequential movements, participants are asked to     do different task tests at Day 2, Week 4 and Week 12. Brain wave activity, and brain     excitability are also measured during these days. In one task, they see a random series of     letters on a screen during the sequential finger movements and are asked to say the number of     times they see a specific letter. In another task, they are asked to focus on each specific     movement while performing the sequential finger movements. During each visit, they are     questioned and evaluated for the development of any abnormal movements that may be suggestive     of early dystonia.      All participants have an electroencephalogram (EEG) and transcranial magnetic stimulation     (TMS) at Day 1, and Day 2 and at Week 4 and Week 12 to evaluate brain activity. For the EEG,     electrodes are placed on the subject's scalp and the electrical activity of the brain is     recorded while the subject performs the sequence of finger movements. For TMS, a wire coil is     held on the subject's scalp. A brief electrical current is passed through the coil, creating     a magnetic pulse that stimulates the brain. The effect of TMS on the muscles is detected with     small electrodes taped to the skin of the subject's arms or legs.   "
189953|NCT00325442|"     This study was an international, multi-center, randomized, double-blind, placebo-controlled     study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e.,     endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred     at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test.     Study procedures included routine blood tests, medical history, physical exams, disease     evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select     centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.      Patients who completed all assessments for 16-weeks were also eligible to enter an     open-label, extension phase study (FREEDOM - EXT).   "
189954|NCT00325455|"     To assess the cholesterol changing effects of MK0859 in patients with primary     hypercholesterolemia or mixed dyslipidemia.   "
189927|NCT00325104|"     This study will evaluate the benefits and side effects of a new medication called Cinacalcet     for treating patients with primary hyperparathyroidism associated with multiple endocrine     neoplasia type 1 (MEN1) or type 2A (MEN2A). Patients with primary hyperparathyroidism have     elevated levels of blood calcium caused by too much parathyroid hormone released by one or     more parathyroid tumors. The parathyroids are small glands located in the neck. Most cases of     primary hyperparathyroidism are due to a single overactive parathyroid gland, but in MEN1 and     MEN2A, several glands are overgrown and overactive. Cinacalcet decreases the secretion of     parathyroid hormone.      Patients 18 years of age and older with primary hyperparathyroidism and MEN1 or MEN2A and who     are not candidates for parathyroid surgery may be eligible for this study.      Participants are admitted to the Clinical Center for 1 week blood and urine tests and imaging     studies, and initiation of Cinacalcet treatment. They take the drug by mouth and have daily     blood tests until the dosage required to achieve normal blood calcium levels is determined.     Patients return to the hospital 2 weeks later for 1 week to evaluate the response to the drug     and make any necessary adjustments. Treatment may continue for as long as 1 year with 1-week     admissions every 3 months to monitor the benefits and side effects of Cinacalcet. Evaluations     may include the following:        -  Blood and urine analyses.        -  Measurement of gastric acid secretion. For this test, a soft plastic tube is inserted          into the nose or mouth and then swallowed and then gently removed about an hour later.        -  Injections of secretin, calcium and arginine into a vein and collection of blood samples          to measure the responding increase in levels of gastrin, calcitonin and insulin,          respectively. These tests are used to diagnose and monitor hormone secretion from          endocrine tumors and are used in this study to assess the response to Cinacalcet          treatment.        -  Radioisotope test to evaluate tumors of the endocrine organs. A radioactive substance          injected into a vein is taken up by the endocrine tissue and the concentrated          radioactivity is measured.        -  Imaging tests, such as MRI and CT, to detect or follow growing tumors in the pituitary,          neck, and abdomen. CT is a special type of x-ray machine that visualizes tissues, such          as thyroid or parathyroid tumors. MRI uses a magnetic field and radio waves to obtain          pictures of different tissues in the head, neck and abdomen.        -  DEXA scan to assess bone density. This test uses standard low-intensity x-rays.   "
189928|NCT00325117|"     This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic     agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind,     parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of     vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes     inadequately controlled with sulfonylurea monotherapy.   "
189929|NCT00325130|"     Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) [Types     6, 11, 16, 18] Recombinant Vaccine) , when administered concomitantly with a combined     diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in     adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity     of the concomitant vaccines.   "
189930|NCT00325143|"     To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib     vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK     Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to     comply with the FDA Amendment Act, Sep 2007.   "
189931|NCT00325156|"     To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster     vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with     GSK Biologicals' rotavirus vaccine or Placebo.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
189946|NCT00325351|"     The purpose of this study is to evaluate whether treatment with a new drug called     ZK-Epothilone (ZK-Epo) given with carboplatin in patients with recurrent ovarian cancer, who     previously have had a good response with cisplatin or carboplatin, is safe and helps to     decrease or stop tumor growth.   "
189933|NCT00325182|"     This study will attempt to examine whether Levetiracetam (Keppra (TM)) can help people with     alcohol dependence cut down on their alcohol consumption. In addition, the investigation will     assess the effectiveness of Keppra on reducing withdrawal symptoms post alcohol cessation.     Matched group of historical controls of alcohol dependent patients receiving placebo will be     used for comparison.Based on the mechanism of action of Keppra we hypothesize that it may be     effective in promoting abstinence and reducing drinking behavior in alcohol dependent     patients.   "
189934|NCT00325195|"     These are two replicate studies to evaluate the safety and efficacy of PEG (polyethylene     glycol)-uricase in controlling the uric acid level in symptomatic gout patients with high     uric acid levels who are unable to take standard gout therapies, or for whom those therapies     have been unsuccessful in controlling their uric acid level.   "
189935|NCT00325208|"     It is increasingly recognised that rapid growth in infancy may be associated with a greater     risk of cardiovascular disease later in life. This trial will investigate whether the use of     infant feeding bottles with different designs influences the milk intake and growth of     infants. We will compare the growth of bottle-fed infants with that of a breast-fed reference     group.   "
189936|NCT00325221|"     Quality of life (QOL) and psychological well-being of patients with implantable     cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock     therapies. A close therapeutic relationship between patients and physicians, resulting in     short reaction times to ICD-treated arrhythmic events and, in an optimised antiarrhythmic     therapy, may help the patients to deal with their situations in the best possible way.      The researchers investigate the influence of automatic remote patient monitoring on QOL,     anxiety, and depression in ICD patients, and kind and frequency of (un-)scheduled     patient-physician contacts. They also evaluate monitoring-induced changes in patient mobility     and in patients' perceptions of ICD therapy.   "
189937|NCT00325234|"     The primary purpose of this study is to help answer the following research questions:        -  whether the chemotherapy combination therapy Pemetrexed-Carboplatin or          Gemcitabine-Vinorelbine can help participants with advanced breast cancer to make the          tumor smaller or disappear and for how long        -  to learn more about the side effects in each chemotherapy combination treatment arm        -  to assess how participants with advanced breast cancer report health changes while          receiving any of the chemotherapy combination arm   "
189955|NCT00325468|"     An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab     Administration in Postmenopausal Women with Low Bone Mineral Density   "
189956|NCT00325481|"     To assess the safety of a bivalent vaccine of two new influenza virus reassortants in healthy     adults prior to the release of the trivalent vaccine (FluMist) containing them.   "
189957|NCT00325494|"     The purpose of this study is to establish the safest doses of an investigational drug called     MORAb-009 in subjects with pancreatic cancer, mesothelioma, or certain types of ovarian or     lung cancer. MORAb-009 is a monoclonal antibody that is directed to an antigen on the surface     of these cancers.   "
190108|NCT00333164|"     Multi-center, open-labelled randomized controlled trial, to study the effect of aspirin plus     cilostazol and aspirin alone on the progression of intracranial arterial stenosis, in 200     chronic stroke patients with 50-99% stenosis, to be followed up for 2 years   "
189938|NCT00325247|"     Diarrhoea continues to be a major cause of mortality and morbidity in young children     especially in many developing countries. Although the mortality burden of diarrhoea has     substantially reduced, the morbidity pattern remained almost unchanged. Recent randomized     controlled supplementation trials in developing countries have consistently shown that zinc     has the potential to reduce the duration of diarrhoea as well as has preventive effect on     childhood diarhroea in subsequent months. Currently, international health agencies recommend     zinc as an important adjunct therapy to treat diarrhoea in developing countries where zinc     deficiency is highly prevalent and diet is poor in zinc.      The recommendation is to provide 20 mg elemental zinc daily for 10 days during each episode     of diarrhoea.      This study aims at evaluating the relative efficacy of two length of 20 mg zinc therapy (5 vs     10 days) during acute diarrhoea in a rural community in a community-based individually     randomized placebo-controlled trial with 20 mg zinc daily and will be conducted in seven     villages in the ICDDR,B Matlab study area.      The study will require 2050 acute dirrhoeal episodes to be treated who will be randomly     allocated to one of the two treatment schedules (20 mg of zinc daily for 5 or 10 days).     Children who will be allocated to the shorter duration therapy will receive placebo for the     remaining days to complete 10-day treatment. Female Field Workers (FFWs) will conduct     diarrhoea surveillance and administer zinc daily at home. Data will be analyzed using     appropriate statistical procedure.      Findings of this study will be immensely valuable for deciding recommendation for the     duration of zinc therapy in the management of acute diarrhoea in young children and will have     profound programmatic and policy implications for scaling up zinc intervention in the     community.   "
189939|NCT00325260|"     In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is     already on the market in China. The main objective of the study is to show that both vaccines     are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac     will be assessed in the Chinese population.   "
189940|NCT00325273|"     The purpose of this study is to determine whether childhood atopic disease decrease or not     after allowing allergic mothers intake of probiotic (Lactobacillus GG) in second trimester,     followed by infant intake for 6 months after birth.   "
189941|NCT00325286|"     This is an open label design using Lithium plus extended release carbamazepine (Equetro) in     combination for 6 months. Rapid cycling bipolar disorder is frequently treatment refractory     and associated with repeated hospitalizations and complications. The results of this study     will offer a promising approach to treat this complex disorder. The primary efficacy measure     will be the time to relapse. Relapse will determined by the investigator based on the     following: Need for additional pharmacotherapy for mood-related symptoms, hospitalization for     an mood episode, increase of more than 50% in HAM-D and YMRS scores from the baseline visit.   "
189942|NCT00325299|"     The primary purpose is to see if magnesium tablet supplementation will decrease elevated GGT     enzyme activity in alcoholic patients immediately after they had been treated for alcohol     withdrawal. The secondary aims are to find out whether supplementation decreases the activity     of ASAT and ALAT enzymes, increases muscle strength, decreases blood pressure and decreases     depressive symptoms among these patients.   "
189943|NCT00325312|"     The purpose of the trial is to evaluate whether patients with acute non specific neck pain     get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to     sham ultrasound.   "
189944|NCT00325325|"     The purpose of this study is to address the pharmacokinetic (PK) profiles of everolimus and     tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per     day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be     performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation.   "
189945|NCT00325338|"     Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for     patients with hypersensitivity to ragweed pollen (hay fever). This novel formulation is     designed to provide a vaccine that will be efficacious with only four escalating dose     injections administered before the start of the pollen season. In this Follow-up Study the     Efficacy will be assessed by exposing allergic subjects to Ragweed pollen in an environmental     exposure chamber EEC. Patient symptomatic response to pollen and patient quality of life in     the EEC will be determined. Patients who previously completed two EEC portions of study     Ragweed MATAMPL 204 and who had been treated with either Ragweed MATA MPL or Placebo before     the 2005 ragweed season will be enrolled.   "
190151|NCT00334399|"     The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in     patients with Type2 Diabetes Mellitus treated with Biguanide.   "
189947|NCT00325364|"     This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the     Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking     patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month     follow-up period.   "
189948|NCT00325377|"     The purpose of this study is to test whether or not the Magnetic Molecular Energizer (MME)     device provides a well tolerated and effective intervention to reduce pain, pain-related     symptoms and improve ability to function in those diagnosed with the condition “Chronic Low     Back Pain” (chronic LBP).   "
189949|NCT00325390|"     To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance     dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients     with acute coronary syndrome without ST-segment elevation and planned for percutaneous     coronary intervention(including stenting).   "
189950|NCT00325403|"     This study was an international, multicenter, randomized (2:1 active:placebo), double-blind,     placebo-controlled study in subjects with PAH who were NOT currently receiving approved     therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an     additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test.     Study procedures included routine blood tests, medical history, physical exams, disease     evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at     select centers - a hemodynamic substudy with a right heart catheterization at Baseline and     Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and     Week 12.      Patients who completed all assessments for 12 weeks were also eligible to enter an     open-label, extension phase study (FREEDOM - EXT).   "
189951|NCT00325416|"     The purpose of this research study is to determine the safest dose of topotecan when given in     a high dose before a stem cell transplant; topotecan will be given with melphalan.   "
189952|NCT00325429|"     This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic     agent. This 52-week clinical study is designed as an open label, long-term study aimed to     evaluate the safety of vildagliptin in patients with type 2 diabetes.   "
189968|NCT00325637|"     The purpose of this study is to compare the effect of cilnidipine (a calcium channel blocker)     and losartan (an angiotensin II receptor blocker) on cerebral blood flow (CBF) and blood     pressure in hypertensive patients with a previous ischemic stroke.   "
189958|NCT00325507|"     The purpose of this study is to assess the safety and tolerability of TroVax® investigational     vaccine injections when given as first or second line treatment in conjunction with     subcutaneous low dose IL-2 to patients with locally advanced or metastatic clear cell or     papillary cell renal carcinoma.      TroVax® is the experimental product in this trial and its value as a medicine has not yet     been proven. Interleukin-2 (IL-2) is a standard treatment for cancer, which means that it can     be received even if one chooses not to participate in this study. TroVax® is being studied as     a possible treatment for patients with cancer of the kidney.      TroVax® belongs to a class of medicines called vaccines. A vaccine helps the body's immune     system to recognize and kill foreign invading organisms effectively. It is believed that one     of the reasons why cancer can spread through the body is that the immune system cannot     recognize cancer cells as being different from normal tissues and therefore cannot kill the     cancer cells. A vaccine that alerts the immune system to the presence of cancer cells in the     body could lead to the immune system being able to target and kill those cancer cells     effectively. This trial is of a completely new way of trying to treat cancer in the future by     the use of vaccination injections. TroVax® consists of a virus that has been changed so that     it is no longer infectious and carries a gene for a protein called 5T4. This protein is     carried by many kidney cancer cells. When the virus is injected, it makes the protein, and     the body's immune system is then able to recognize this protein and kill the cells that have     it (i.e. the cancer cells).      The purpose of this study is to assess the safety and tolerability of TroVax® injections and     to understand whether TroVax® could make such an immune response happen in patients with     renal cell cancer while receiving interleukin-2 (IL-2). This study will also observe and     monitor any side effects experienced in patients who receive TroVax® while being treated with     IL-2.   "
189959|NCT00325520|"     The purpose of this study is to investigate thought processes and neural mechanisms that may     contribute to the development of habitual behaviors. The investigators hypothesize that     patients with AN will perform differently than people without eating disorders on a series of     neuropsychological tasks and will show different neural activation patterns in functional     neuroimaging scans.   "
189960|NCT00325533|"     Black men in the United States have a greater risk of developing high blood pressure than men     of any other ethnic or racial group. The purpose of this study is to evaluate the     effectiveness of a high blood pressure detection and medical referral program conducted by     barbers in predominantly Black barbershops at increasing awareness and lowering blood     pressure levels among their Black male customers.   "
189961|NCT00325546|"     Primary : effect on weight loss and weight maintenance over 9 months when prescribed with a     hypocaloric diet in obese patients.      Secondary : effect on HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist     circumference - safety and tolerability   "
189962|NCT00325559|"     This study aims at investigating the effect of hyperglycaemia on physical performance and     local energy stores in the muscle in patients with type 1 diabetes mellitus under exercise     conditions.   "
189989|NCT00325910|"     To conduct a pilot study to evaluate the feasibility of a large randomized controlled trial     (RCT) of metformin in patients with heart failure and type 2 diabetes and to generate initial     morbidity and mortality estimates in this patient population. The primary hypothesis is that     subjects with heart failure and type 2 diabetes who receive metformin will have a significant     reduction in the combined endpoint of all-cause mortality and all-cause hospitalization as     compared to subjects who receive placebo therapy.   "
189963|NCT00325572|"     There are two phases to the study. The first will examine serum copper and zinc levels and     copper/zinc ratio in children (ages 3-8) who have autism and compare them to levels from same     sex and age children who are developing typically. The hypothesis is that there is a     significant difference in the copper/zinc ratio between young children who have autism and     their typically developing peers.      The second phase of the study will evaluate the effect of dietary supplementation using zinc     and vitamin C for 16 weeks on selected symptoms of autism. Children with autism will be     enrolled on the basis of copper/zinc ratios greater than 2.0, and as determined to be     statistically higher than typically developing children. Measurements of serum copper, zinc     and unbound copper will be obtained prior to, at the mid-point and end of the trial. Those     children whose ratios have not fallen below 1.25, the top of thecurrently recognized range     will have the zinc and vitamin C doses adjusted for the duration of the trial. Detailed     evaluation of language skills, and a variety of behaviors will be evaluated prior to and     after supplementation. The study will be placebo-controlled and double blind. Those children     enrolled in the placebo arm will be offered a full trial of supplements at the end of the     their participation in the study.      The hypothesis to be tested is whether correction of elevated copper to zinc ratios in     children with autism can be accomplished by oral supplementation with zinc and vitamin C and     if these children show measurable and significant changes in receptive or expressive language     or behavioral parameters associated with autism.   "
189964|NCT00325585|"     Recent studies have shown that many drug-using minority women are vulnerable to HIV infection     from their husbands or other intimate male partners. The goal of this study is to develop and     evaluate two new HIV counseling and testing programs designed for drug-using women at risk     for HIV from a primary male partner. It is predicted that HIV counseling and testing programs     administered to couples rather than to women only, and programs that focus on intimate     relationships in the context of HIV risk, will result in a reduction of risky sexual and     drug-related behavior among drug-using women and their primary male partners. This four-year     study employs a randomized clinical trial (RCT) design to test the effectiveness of two new     HIV counseling and testing programs for women drug-users in Harlem and the South Bronx in New     York City.   "
189965|NCT00325598|"     This study investigates the feasibility and safety of delivering radiation therapy only to     part of the breast, (the tumor bed and selected areas) rather than the whole breast, for     patients with early stage breast cancer.   "
189966|NCT00325611|"     Palliative care is believed to improve care of patients with life-limiting illnesses. This     study evaluated the impact of a multi-center randomized trial of a palliative care team     intervention on the quality and cost of care of hospitalized patients. Study subjects were     randomized to intervention or usual care. At study end, patients receiving the palliative     care intervention reported greater patient satisfaction with their care. Intervention     patients also had significantly fewer ICU admissions and lower total costs for care 6 months     past their hospitalization. Intervention patients completed more advance directives and had     longer hospice stays.   "
189967|NCT00325624|"     The purpose behind the proposed research is that diabetes care in First Nations people can be     improved by involvement of a Home Care team providing diabetes education and management,     supported by emerging technology, specifically Bluetooth-enabled glucometers and blood     pressure monitors, capable of transmitting their data to a web environment in tabulated and     graphical format available for remote viewing.   "
190013|NCT00326222|"     The purpose of this randomised open study is to examine the effect of self-management program     for diabetes patients.   "
189969|NCT00325650|"     Primary objective:      To evaluate the effect of long-term administration of Rimonabant on the time of progression     to type 2 diabetes in patients with prediabetes (i.e. Impaired Fasting Glucose (IFG) or     Impaired Glucose Tolerance (IGT) or both at baseline).      Secondary objectives:        -  To assess the effect on weight loss and weight maintenance; sustained effect following a          washout period, effect on other markers of glycemic control (fasting glucose,          fasting-insulin and HbA1c), glucose tolerance and insulin responses during oral glucose          tolerance tests (OGTTs), and on other risk factors (HDL-Cholesterol, TG),        -  To assess the effect on quality of life        -  To evaluate long term safety and tolerability.   "
189970|NCT00325663|"     The aim of this study was to evalute three different acupuncture techniques, including one     sham control, in its effect on osteoarthitis of the knee   "
189971|NCT00325676|"     The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study     discontinuation rates, and quality of life parameters in patients with erosive GERD. The     study duration consists of a treatment period up to 16 weeks according to the classical     healing concept or the complete remission concept. During this period, the patients will     receive pantoprazole (tablet) at one dose level once daily. The following observational phase     lasts up to 6 months. The study will provide further data on efficacy, safety, and     tolerability of pantoprazole.   "
189972|NCT00325689|"     A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with     Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic     treatment.   "
189973|NCT00325702|"     This project will develop, implement, and evaluate a community-level intervention for Black     and White substance-using MSM between the ages of 15 and 29. The intervention is designed to     change both social norms and risk behavior using persuasive media communication and     interpersonal networking as primary intervention strategies.      Qualitative data from focus groups and interviews will inform the development of the     intervention. The effects of the intervention will be assessed through annual interviews with     young Black and White MSM in Philadelphia where the intervention will be implemented and in     Baltimore, our comparison community.   "
189974|NCT00325715|"     AGN 201904, a proton pump inhibitor, versus esomeprazole in the prevention of stomach or     upper intestinal damage following administration of high-dose aspirin in healthy volunteers   "
189975|NCT00325728|"     The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), in     subjects with mild to moderate Alzheimer's Disease and sleep disturbance   "
190330|NCT00323947|"     This study will evaluate the safety and effectiveness of extended release methylphenidate     (XR-MPH) in treating attention deficit hyperactivity disorder (ADHD) in children with both     ADHD and epilepsy.   "
189976|NCT00325741|"     The Stanford Medical Center Division of Immunology and Rheumatology and the Division of Blood     and Marrow Transplantation (BMT) are enrolling patients with severe systemic lupus     erythematosus (SLE) that is resistant to standard treatment (prednisone and cyclophosphamide     [Cytoxan]) into a new study to determine if they can be successfully treated with a blood     stem cell transplantation obtained from an appropriate donor. Donors will be human leukocyte     antigen (HLA)-matched healthy brothers or sisters. For patients without sibling HLA-matches,     a search for donors will be initiated through the US and International Donor Registries.     Eligible patients must be at least 18 years old and have SLE with progressive kidney, lung,     heart, or central nervous system disease that has not responded to standard therapy.      Patients will be treated for two weeks to prepare them for the infusion of blood stem cells     that are obtained from their HLA-matched donor. Patients will initially be treated with     immunosuppressive drugs, which will be gradually withdrawn at approximately 6 months after     transplantation. The goal of this study is to replace the abnormal immune cells of the SLE     affected patient that causes the disease with normal immune cells that are generated from the     transplant blood stem cells from the healthy donor.   "
189977|NCT00325754|"     Chronic Obstructive Pulmonary Disease (COPD) affects over 14 million people in the United     States. It is the fourth leading cause of death and the only leading cause of death for which     mortality rates are rising. Medical science has developed few effective therapies for COPD.     In patients with advanced COPD and chronic hypoxemia, long-term oxygen therapy (LTOT) has     been shown to be uniquely beneficial. It is the only available non-surgical therapy     demonstrated to prolong survival in these patients. This study will compare the clinical and     physiologic benefits of two different oxygen therapy devices among hypoxemic individuals with     COPD: a lightweight ambulatory oxygen device versus the standard portable E-cylinder device.   "
189978|NCT00325767|"     The purpose of this study is to determine whether lung mucociliary clearance (MCC) can be     significantly enhanced in healthy subjects by one week of inhalation of nebulized     levalbuterol aerosol, as compared to racemic albuterol or placebo. Subjects will inhale one     week of levalbuterol, one week of racemic albuterol, and one week of placebo, in a randomized     order.   "
189979|NCT00325780|"     This study is a long-term follow-up protocol for patients who participated in study     NK-104-3.01EU or study NK-104-3.02EU.   "
189980|NCT00325793|"     Hypertension (high blood pressure) can often cause neurological worsening in patients with     stroke, intracerebral hemorrhage and subarachnoid hemorrhage. Intravenous infusion of     nicardipine (Cardene) for control of hypertension is FDA approved. The disadvantage of     Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). The     purpose of this study is to evaluate safety and efficacy of double or triple concentrated     peripheral intravenous (IV) Nicardipine.   "
189981|NCT00325806|"     Primary objective:      Mean values of systolic and diastolic office blood pressure      Secondary objectives:      Total mortality, occurrence of cardio- and cerebrovascular events, change of mean blood     pressure (ABPM : Ambulatory Blood Pressure Monitoring) during the observation   "
189982|NCT00325819|"     The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol)     for routine infant vaccinations is helpful in preventing fever or other symptoms.   "
190026|NCT00326391|"     The purpose of this study is to evaluate the effectiveness and safety of methylphenidate HCl     extended-release tablets at five dose levels compared to placebo in adults with Attention     Deficit Hyperactivity Disorder (ADHD)   "
190027|NCT00326404|"     The primary purpose of this study is to compare the compliance rates of adolescents who take     oral contraceptives (OCPs) continuously to those who take OCPs cyclically.   "
189983|NCT00325832|"     To determine if the use of automated office blood pressure readings can improve management of     systolic hypertension in routine clinical practice. Automated office SBP recordings in     routine clinical practice using the BpTRU device will reflect more accurately the mean awake     ambulatory systolic BP than will manual BP readings taken with conventional mercury     sphygmomanometry. This should lead to improvements in the management of systolic hypertension     with optimization of drug therapy in practices using the BpTRU device.   "
189984|NCT00325845|"     The objective of this investigation is to evaluate the safety and efficacy of     viscosupplementation in treating symptomatic lumbar facet joint arthropathy. The intended use     of the device (Synvisc) is to alleviate pain and improve function in patients with painful     lumbar facet joint arthrosis by intra-articular injection into the involved joint.   "
189985|NCT00325858|"     The purpose of this study is to compare the effectiveness of multiple doses of once daily     tramadol HCl ER (100, 200, 300 and 400 mg) to placebo in patients with moderate to severe     pain due to OA. The study hypothesis is that tramadol HCl ER is safe and effective in the     treatment of patients with moderate to severe pain due to OA.   "
189986|NCT00325871|"     Colorectal cancer (CRC) is one of the common malignancies worldwide, accounting for a     significant percentage of cancer mortality. Concurrent chemoradiation (CCRT) is now a     standard treatment for unresectable malignancies of anorectum. To improve quality of life,     CCRT is also commonly applied in treatment of lower rectal and anal canal cancer to preserve     anal sphincter function. The most commonly used chemotherapeutic drugs combined with     radiation as radiosensitizers is 5-fluorouracil (5-FU). Circulating endothelial progenitor     cells (EPC), which contribute to the tumor vessel formation, reflect the response to     chemotherapy both in animal model and clinical trial. Thus, circulating EPC can be used as a     marker for optimizing and monitoring the anti-angiogenesis therapy including angiogenesis     inhibitors and chemotherapy. Whether circulating EPC can be served as a marker of CCRT     efficacy or not remains undetermined. Since CCRT is now a standard treatment of locally     advanced and high-risk CRC, the development of a surrogate marker for monitoring CCRT     response and optimize treatment intensity is very important.      In this grant we intent to monitor the levels of circulating EPC in locally advanced and     high-risk CRC patients before, during and after CCRT. To further characterize the changes in     function and biology of EPC caused by CCRT, a syngeneic animal model will be also used to     evaluate the clonogenecity and specific gene expression of EPC in tumor-bearing mice     receiving CCRT.   "
189987|NCT00325884|"     The purpose of this study is to assess the long-term clinical outcomes after stenting     bifurcation coronary artery lesions, and to determine whether simple or more complex     techniques are associated with a better clinical outcome. We will also assess the risk     factors associated with poorer clinical outcomes   "
189988|NCT00325897|"     The purpose of this study is to determine if long-term administration of a macrolide     antibiotic will reduce worsening of symptoms among individuals with chronic obstructive     pulmonary disease (COPD).   "
194717|NCT00393926|"     The purpose of the study is to examine how a novel robot technology designed for eventual use     as a home therapy can improve arm function after stroke.   "
189990|NCT00325923|"     The aim of this study is to assess the impact of a patient decision aid regarding natural     health products for menopausal symptoms on decisional conflict, knowledge and persistence for     an option of women aged 45-64 years old. We are expecting a decrease in decisional conflict     and an improvement on knowledge level. We are also expecting an intention to use the decision     aid in the future and to discuss with the physician or pharmacist about the use, or the     intention to use natural health products.   "
189991|NCT00325936|"     Abnormalities of glucose, insulin and lipoprotein metabolism are common in patients with     hypertension, and these metabolic abnormalities are reported to be related to insulin     resistance. Therefore, whenever treating such patients, antihypertensive agents that may have     the added effect of improving insulin resistance should be selected. CinalongTM (Cilnidipine)     is expected to improve metabolic syndrome as well as insulin resistance by its dual effects     on L and N-type calcium (Ca) channels. In this study, the researchers investigate the effects     of CinalongTM on insulin resistance and other metabolic related factors.   "
189992|NCT00325949|"     This is a study of the safety and pain-relieving ability of extended release hydrocodone and     acetaminophen tablets in patients with moderate to severe low back pain   "
189993|NCT00325962|"     The purpose of this study is to determine whether 6R-BH4 (sapropterin dihydrochloride) is     safe and effective in the treatment of poorly controlled hypertension in the presence or     absence of type 2 diabetes.   "
189994|NCT00325975|"     This study will examine how people s immune systems respond to inoculation with vaccinia     virus the standard vaccine used to protect against smallpox and how these responses correlate     with symptoms they develop after receiving the vaccine.      People 18 years of age and older who are scheduled to receive smallpox vaccination as a     routine part of their employment (e.g., laboratory worker, health care worker, or emergency     response worker) may be eligible for this study. They may or may not have been vaccinated     previously. In addition, individuals who were vaccinated against smallpox at least 6 months     before starting the study may participate as control subjects. All candidates will be     screened with a brief medical history and physical examination.      Participants in the following vaccination categories will undergo the procedures described     for their group:      Vaccine Recipient Frequent Follow-up      Participants will come to the NIH Clinical Center every 2 to 3 days for a total of 7 visits     over a 2-week period. At each visit, starting the day of vaccination, they will have the     following procedures:        -  Brief skin examination, possibly with photographs of skin lesions;        -  Throat and skin swabs for vaccinia virus culture;        -  Blood draw (about 8 teaspoonfuls).      Additional blood samples will be collected 1 month after vaccination and again within a year     after vaccination. The blood will be analyzed for the immune response to the vaccine, genetic     differences that might influence differences in immune response, and the presence of vaccinia     virus.      Participants will fill out a diary card every day for 3 weeks after vaccination to record any     symptoms. Individuals who develop symptoms lasting more than 2 weeks, such as persistent or     new skin lesions, will return to the clinic for additional skin exams and blood tests.     Individuals who develop vaccine side effects may have a urine culture for vaccinia virus.      Vaccine Recipient Infrequent Follow-up      Participants will come to the NIH Clinical Center for blood tests on the day of vaccination,     4 weeks after vaccination, and once again within a year after vaccination. At each visit, 6     teaspoonfuls of blood will be drawn. This group will also include individuals who have been     vaccinated within 8 months of entering the study and are not currently receiving the vaccine,     but for whom blood samples are not available.      Control Group Vaccinated at Least 6 Months Before Entering the Study      Participants will come to the NIH Clinical Center for blood tests every 2 to 3 days for 2     weeks, then at 1 month after the first blood draw, and again within a year of the first blood     draw. About 8 teaspoonfuls of blood will be drawn at each visit.   "
190028|NCT00326417|"     The purpose of the current study is to continue to optimize conditioning regimens in     high-risk patients with severe aplastic anemia transplanted with marrow from HLA-compatible     unrelated donors. Specifically, the study will determine whether the addition of fludarabine     to the conditioning regimen previously described by Deeg et al. will permit a reduction in     the CY dose, to a point where sustained hematopoietic engraftment and survival are maintained     (or improved), while the frequency of major regimen-related toxicity (RRT) and early deaths     is reduced.   "
189995|NCT00325988|"     This study will identify biomarkers (genes and proteins) in patients with relapsing-remitting     multiple sclerosis (MS) and link them with clinical disease parameters, such as the extent of     inflammation and rate of disease progression, to try to better understand the disease. It     will examine how the biomarkers may be related to disease development and progression and     differences among patients' symptoms and response to treatment.      Patients with relapsing-remitting MS between 18 and 60 years of age who are enrolled in the     multi-institutional MS-CombiRx trial may be eligible for this sub-study. Participants have     blood tests when they enter the MS-CombiRx study and again after 6 months, 1 year, and 3     years for analysis for genetic and protein analysis.   "
189996|NCT00326001|"     The purpose of this study is to demonstrate the advantage of using a gold alloy tip electrode     over a platinum/iridium alloy tip electrode in ablation of the cavotricuspid isthmus in     patients with atrial flutter.   "
189997|NCT00326014|"     To evaluate the safety and efficacy of a new trabecular bypass that is implanted in     conjunction with cataract surgery in open angle glaucoma subjects.   "
189998|NCT00326027|"     The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in     hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux     disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a     patient-orientated, self-assessed reflux questionnaire (ReQuest™). The study duration     consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered     once daily in the morning to patients with NERD or GERD at one dose level for each     indication. The study will provide further data on the safety and tolerability of     pantoprazole.   "
189999|NCT00326040|"     The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular     micro-bypass stent in reducing intraocular pressure (IOP) in refractory open-angle glaucoma     subjects.   "
190000|NCT00326053|"     The purpose of this study is to compare the Symbicort® Turbuhaler® to both Pulmicort®     Turbuhaler® and Bricanyl® Turbuhaler® for the treatment of asthma after discharge from the     emergency room   "
190001|NCT00326066|"     The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular     micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed     open-angle glaucoma and subjects diagnosed with Ocular hypertension.   "
190002|NCT00326079|"     The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular     micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle     glaucoma.   "
190003|NCT00326092|"     The purpose of this study is to assess the comfort of a glaucoma therapy in patients with     open-angle glaucoma or ocular hypertension   "
190004|NCT00326105|"     The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an     antidepressant versus an antidepressant alone in patients with MDD with inadequate response     to an antidepressant treatment.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
190005|NCT00326118|"     The purpose of the primary phase of the study is to demonstrate the non-inferiority of a     single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC)     conjugate vaccine when given in the second year of life to subjects primed in infancy with a     Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available     Hib and MenC vaccines.      In the extension phase, at Years 1, 2, 3, 4 & 5, one blood sample is taken at each year to     follow the antibody persistence up to 5 years after vaccination. No additional vaccine is     administered during the extension phase. The Protocol Posting has been updated in order to     comply with the FDA Amendment Act, Sep 2007.   "
190006|NCT00326131|"     The first purpose of this study is to determine how the body absorbs, metabolizes, and     eliminates a single dose of BMS-275183 (labeled with radioactive carbon). Secondly, to     measure the levels of BMS-275183 in your blood, study the safety of the drug, and to see what     effects it has on your cancer.   "
190007|NCT00326144|"     The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate     sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the     treatment of Major Depressive Disorders PLEASE NOTE: Seroquel SR and Seroquel XR refer to the     same formulation. The SR designation was changed to XR after consultation with FDA.   "
190008|NCT00326157|"     This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome®     loading dose regimen, in a weekly administration schedule during the initial phase of     allogeneic stem-cell transplant and in case of occurrence of graft versus host disease     (GvHD), which are both high risk periods as far as severe fungal infection development is     concerned.   "
190009|NCT00326170|"     5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS).     Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the     effects of 5-aza. The goal of this clinical research study is to find the highest safe dose     of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and     all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness     of this combination therapy will also be studied.      Additional blood and bone marrow samples will be requested. These samples will be used to     evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and     bone marrow samples that are collected at the start of the study and during the regularly     scheduled evaluations to be sent for research studies. The research studies will examine     changes in the blood and bone marrow cells that might help explain the causes of leukemia and     MDS and how the combination of 5-aza, VPA, and ATRA works.   "
190010|NCT00326183|"     Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella     [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data     will be collected following each vaccination.   "
190011|NCT00326196|"     This is a randomized, multi-site, clinical trial comparing percutaneous coronary stenting     (PCI) with drug eluding stents to coronary bypass for angiographically significant coronary     artery disease in diabetes. The hypothesis being tested is that a strategy of surgical     revascularization is superior to percutaneous intervention in preventing death or myocardial     infarction in diabetics with severe ischemic heart disease.   "
190012|NCT00326209|"     To evaluate the long-term safety and tolerability of mesalamine pellets (MP)in patients with     ulcerative colitis currently in remission.   "
190014|NCT00326235|"     Dependence on heroin is a major public health problem because of its association with     criminality, law enforcement costs and healthcare costs. Managed withdrawal is a required     first step for a long term drug-free treatment of heroin addicts. Methadone and clonidine     have been the mainstay of treatment for the relief of heroin withdrawal symptoms but both     have limitations. The purpose of this study was to evaluate the efficacy of buspirone in the     alleviation of the withdrawal symptoms experienced by heroin addicts when they stop using     heroin. Buspirone is a non opiate drug with no abuse potential, no sedating effects and no     withdrawal symptoms.   "
190015|NCT00326248|"     This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will     significantly decrease the number of patients who experience nausea and vomiting after     surgery.   "
190016|NCT00326261|"     Nerve blocks for arm and hand surgery provide many advantages for patients including     excellent pain control and reduction in general anesthesia-related adverse effects.     Infraclavicular block is possibly the best method for performing regional anesthesia of the     arm because of the consistent anesthesia of the whole arm and low incidence of serious     adverse effects. Normally the anesthetist uses nerve stimulation to identify nerves supplying     the forearm and hand. Recent research has indicated that to improve success from 60% to 79%     two types of muscle stimulation must be sought before injection of local anesthetic. This can     be time consuming, requires a significant learning process, increases complications and     leaves 21% of patients with inadequate anesthesia requiring supplementation or general     anesthesia. More recently practitioners have been using ultrasound imaging to direct the     needle and watch local anesthetic spread around the nerves. Preliminary reports have     documented that this technique is associated with much greater success than the nerve     stimulation method. However a good quality study comparing the dual-endpoint infraclavicular     technique with an ultrasound-guided technique has not been performed. This randomized study     aims to rectify this deficiency by determining if ultrasound-guided infraclavicular block has     a significantly greater success than the current standard, dual end-endpoint nerve     stimulation technique.   "
190017|NCT00326274|"     The purpose of this study is to determine the safety potential of Helioblock® SX Cream as a     sunscreen product in long term intermittent use conditions among pediatric subjects.. Each     subject will be enrolled to participate for six months. The test product should be applied     every day that outdoor activities are planned, prior to any significant sun exposure during     out-door activities (such as the beach, outdoor sport activities), or whenever the subject     needs to be protected against sunburn or other damage due to the sun. A minimum of 14 days     test product use and sun exposure is required.   "
190018|NCT00326287|"     The purpose of this study is to compare the clinical cure rate (ratio of clinically cured     patients to the total number of patients) of ceftobiprole medocaril versus a comparator in     the treatment of patients with community-acquired pneumonia.   "
190019|NCT00326300|"     The purpose of this study is to evaluate the long-term safety of methylphenidate HCL     extended-release tablets at five dose levels in adults with Attention Deficit Hyperactivity     Disorder (ADHD)   "
190057|NCT00326820|"     RATIONALE: Ibandronate and zoledronate may help relieve some of the symptoms caused by bone     metastases. It is not yet know whether ibandronate is more effective than zoledronate in     treating bone metastases from breast cancer.      PURPOSE: This randomized phase III trial is studying ibandronate to see how well it works     compared with zoledronate in treating patients with newly diagnosed bone metastases from     breast cancer.   "
190020|NCT00326313|"     Streptococci group B (GBS) is a the major reason for morbidity and mortality in neonates. It     can present as pneumonia ,meningitis or sepsis.The mortality today is 5-20% and even more in     preterm babies.      During the past two decade, the introduction of protocols for prophylactic antibiotics for     women with a high risk for GBS infection, have led to a decline of 65% in GBS cases(0.32 for     1000 live birth compared to 1.8 cases in 1000).The purpose of the study is to check the     morbidity and mortality at Sheba medical center in the last 12 years in children with     positive blood culture for GBS. We assume that in our hospital the morbidity and mortality is     less then expected. If proven right, we would then check the reasons for that outcome     considering the type and length of treatment and the different virulence of the     streptococcus.   "
190021|NCT00326326|"     To assess the effect of CP-778,875 on HDL-C cholesterol in adult subjects with dyslipidemia     and type 2 diabetes   "
190022|NCT00326339|"     This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, ascending     dose, dose ranging study to evaluate up to three doses of R935788 (50 mg bid, 100 mg bid and     150 mg bid). Approximately 180 patients who have had rheumatoid arthritis for a minimum of 12     months and who have been receiving a weekly methotrexate (MTX) dose for a minimum of 6 months     will be enrolled into the study.   "
190023|NCT00326352|"     For reduction of dislocated shoulder, sedation with propofol and remifentanil should give     satisfactory operating conditions and pain relief, and significantly reduce the time to full     recovery, compared with morphine and midazolam   "
190024|NCT00326365|"     The purpose of this study is to determine whether the homeopathic remedy Kali Bichromium is     effective in reducing the amount of tracheal secretions in patients intubated with a     conventional endotracheal tube and receiving controlled mechanical ventilation in the ICU     setting.   "
190025|NCT00326378|"     Non-Small Cell Lung Cancer(NSCLC) is the leading cause of death in Korean men after stomach     cancer. Surgical resection plays a main role for curative treatment. However, less than 20 %     of the NSCLC patients have been found in stage I-II disease. In inoperable stage IIIA/B     disease, the recommended treatment is combined chemotherapy and radiation therapy. Various     kinds of combination of 2 modalities have been used either in sequential or concurrent     setting. Concurrent chemoradiotherapy(CCRT) have been recognized to have better survival than     radiation therapy alone or sequential therapy, but additional consolidation chemotherapy     after CCRT is not yet to be determined for the beneficial role in survival gain. Docetaxel is     an anticancer drug and has synergistic anticancer effect in various cancer with cisplatin,     another anticancer drug. In the present study, randomised trial will be performed to confirm     the efficacy of the consolidation chemotherapy with docetaxel and cisplatin after completing     CCRT with the same chemotherapeutic agents in stage III inoperable NSCLC on progression free     survival and overall survival.   "
190029|NCT00326430|"     The purpose of this study is twofold: (1) to compare the effectiveness of two promising     treatments for social phobia, a new cognitive therapy model (Clark & Wells, 1995; Borge et     al., 2001) and interpersonal therapy (Lipsitz, Markowitz, & Cherry, 1997), adapted for     inpatient groups; and (2) to study the empirical change processes in these therapies and     compare them with the cognitive and interpersonal models of change.   "
190030|NCT00326443|"     The purpose of this research study is to see if giving a typhoid vaccine by mouth (an     experimental vaccine, CVD 909) before giving a vaccine shot (Typhim Vi) will result in a     better immune response than giving Typhim Vi vaccine by itself. Another purpose is to see     whether CVD 909 is safe. Typhim Vi has been shown to be safe and effective in preventing     typhoid fever in older children and adults, but it does not work in children under age 2.     Scientists at the University of Maryland think that young children could respond to Typhim Vi     if they were given a dose of the other typhoid vaccine by mouth before they are given the     Typhim Vi shot. Twenty-eight healthy adult volunteers, ages 18-40 years, will take part in     this study. Study participation will last for up to 63 weeks, but most of the study visits     will be in the first 6 weeks. Blood samples will be collected approximately 13 times. Four     stool samples will be collected. Some volunteers may be followed for an additional 4 years.   "
190031|NCT00326456|"     The purpose of this study is to compare the effectiveness (progression free survival) of the     experimental combination of carboplatin + liposomal doxorubicin with the standard combination     of carboplatin + paclitaxel in first line treatment of patients with ovarian cancer.      Secondary objectives are to evaluate overall survival, quality of life, objective response     rate, and toxicity.   "
190032|NCT00326469|"     To evaluate, in patients with progressive neuroendocrine tumours who are not eligible to be     treated with either surgery or chemotherapy at the moment of study inclusion, the efficacy of     lanreotide Autogel in tumour growth stabilization.   "
190041|NCT00326599|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor. Giving gemcitabine and carboplatin     together with AZD2171 may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and     carboplatin together with AZD2171 works compared to giving gemcitabine and carboplatin     without AZD2171 as first-line therapy in treating patients with stage IIIB or stage IV     non-small cell lung cancer.   "
190033|NCT00326482|"     This study will provide a basis for research on the impact of liver injury caused by     antiretroviral therapy in HIV-infected patients. Elevated liver enzymes called AST and ALT     are common in HIV-infected patients taking antiretroviral medications and can indicate liver     damage. Although there are a number of possible causes for these elevations, such as     infections with a hepatitis virus, antiretroviral medications alone can lead to the     elevations. The study will focus particularly on evidence of liver fibrosis, which is a sign     of progressive liver damage.      HIV-infected patients 18 and older who 1) have been taking combination antiretroviral therapy     for at least 12 months and have been on a stable regimen for at least 3 months, and 2) have     had elevated AST or ALT levels for at least 6 months may be eligible for this study. Patients     who have had liver biopsies performed in the past may be eligible for participation.      Participants undergo the following tests and procedures over a 12-month period:        -  Oral glucose tolerance test: The patient drinks a glucose (sugar) drink. Blood samples          are then drawn over 2 hours through an intravenous (IV) line in the patient's arm. This          test measures how high the patient's blood sugar and insulin levels rise after drinking          a standard glucose load.        -  Transient elastography: This ultrasound test uses vibration (sound waves) to measure          liver stiffness (fibrosis). Vibrations move faster through a fibrotic liver.        -  Triple-phase CT scan and single slice CT scan of L4-5: Patients fast for 4 hours before          the CT scan. A contrast material is injected through a catheter placed in an arm vein to          improve the visibility of the liver in the specialized X-ray images obtained in the CT          scanner.        -  Liver biopsy: This test removes a small sample of liver tissue for microscopic          examination, particularly for evidence of fibrosis. The skin over the biopsy site is          numbed and a needle is passed through the skin and rapidly in and out of the liver.          Patients may be given a sedative for the procedure.        -  Follow-up visits. Patients return for follow-up visits 1 to 4 weeks after the liver          biopsy and three more times over the course of the study for a medical history, physical          examination and blood tests.      Patients may participate in an additional 4-year follow-up, during which they have visits     every 3-12 months and are offered the opportunity to repeat the biopsy no sooner than 1 year     after the first biopsy.   "
190034|NCT00326495|"     Background:        -  Colorectal cancer (CRC) is a major public health problem in the U.S. and worldwide, and          5-year survival with widespread metastatic disease is less than 5%.        -  Expression of epidermal growth factor receptor (EGFR) or up-regulation of the gene          occurs in the majority of CRC cases (60-80%).        -  Therapies targeting EGFR, like cetuximab, have shown activity in the treatment of solid          tumors like CRC.        -  Cetuximab is FDA (Food and Drug Administration) approved for the treatment of          EGFR-expressing CRC, but clinical responses to cetuximab are seen in only 10% of          EGFR-expressing CRC.        -  One possible mechanism of resistance to cetuximab could be KRAS (Kirsten rat sarcoma)          mutations.        -  Another major pathway implicated in colon carcinogenesis is the vascular endothelial          growth factor (VEGF) pathway, which is involved in angiogenesis and is a validated          target for therapy in CRC.        -  BAY 43-9006 is both a Raf kinase inhibitor and an inhibitor of VEGF receptor (VEGFR2)          tyrosine kinase.        -  We hypothesize that the combined inhibition of EGFR, VEGFR2, and the Ras-(rapidly          accelerated fibrosarcoma) Raf pathway will demonstrate promising clinical activity in          CRC. Furthermore, in patients with mutant KRAS, combination of cetuximab with a drug          that inhibits Raf kinase and acts downstream of Ras mutations, could restore tumor          sensitivity to cetuximab.      Objectives:        -  To determine the rate of response (complete response (CR) + partial response (PR) +          stable disease (SD) for 4 months) and toxicity profile of combination of BAY 43-9006 and          cetuximab in previously treated EGFR-expressing metastatic CRC in patients with mutant          KRAS.        -  To evaluate BAY 43-9006 pharmacokinetics & pharmacogenomics (CYP3A4/5 (cytochrome P450          3A4/5)).        -  To evaluate for this combination treatment pharmacodynamics, effect on tumor vascularity          and effect on angiogenic cytokines.      Eligibility:        -  Adults with histologically or cytologically documented, measurable, EGFR-expressing          metastatic CRC, which has recurred or progressed following at least one prior 5FU          (Fluorouracil)-based combination chemotherapy regimen administered for the treatment of          metastatic disease.        -  Patients must be KRAS mutation-positive.      Design:        -  BAY 43-9006 will be administered 400 mg by mouth twice daily        -  Cetuximab will be administered as 400 mg/m^2 loading dose (week 1) followed by 250          mg/m^2 IV (intravenous) weekly.        -  If procedure may be performed safely, tumor biopsy will be obtained prior to treatment          and after 4 weeks of treatment.        -  Optional positron emission tomography (PET)/computerized tomography (CT) imaging with          89Zr-labeled, EGFR-targeting antibody panitumumab may be performed to evaluate radiation          dosimetry, safety, and tumor distribution prior to and following treatment with study          agents.        -  Patients will be evaluated for response every 8 weeks using the RECIST (Response          Evaluation Criteria in Solid Tumors) criteria.        -  This trial uses a phase II optimal design targeting a response rate as defined above of          20% in patients with mutant KRAS. Up to 49 patients may be treated.   "
190035|NCT00326508|"     This study will determine whether treatment with a combination of the drugs daclizumab and     denileukin diftitox can eliminate the need for long-term daclizumab treatment in adult     patients with uveitis. Denileukin diftitox kills white blood cells called lymphocytes that     cause inflammation and may be the cause of uveitis.      Patients 18 years of age and older with uveitis in one or both eyes who are on daclizumab     therapy and have not had a disease flareup in 6 months may be eligible for this study.     Candidates are screened with a medical history, physical examination, eye examination     (including vision test, examination of the front of the eye, and pupil dilation for     examination of the retina at the back of the eye), blood tests and a questionnaire about     their vision and daily activities.      After screening, participants undergo the following procedures:        -  Daclizumab/ denileukin diftitox treatment. Patients receive their regular dose of          daclizumab intravenously (through a vein). The interval between doses is increased by 1          week after each dose. When the doses are 10 weeks apart, the daclizumab is stopped.          Patients who experience a flare or uveitis are treated with intravenous denileukin          diftitox and possibly local injections of steroids around the eye or increasing or          adding other medicines as needed to control the uveitis.        -  Fluorescein angiography to look for blood vessel abnormalities in the eyes. A yellow dye          is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of          the retina (the back portion of the eye) are taken with a special camera that flashes a          blue light into the eye. The pictures show if any dye has leaked from the vessels into          the retina, indicating possible abnormalities.        -  Ultrasound and urine tests at enrollment and after 1 year to check kidneys, lymph nodes          and pelvic area.        -  Blood tests at enrollment and every 3-6 months for laboratory and immunology tests and          other research tests on blood cells to examine the immune response.        -  Follow-up visits approximately every 6 weeks for 2 years for repeat examinations to          determine the response to treatment and drug side effects.   "
190036|NCT00326521|"     Briefly, the investigators propose to evaluate nulliparous (first time mothers) patients     beyond 36 0/7 weeks' gestation in active labor who already have received epidural anesthesia     and have an intrauterine pressure catheter (IUPC) in place. Any patient who then develops a     single temperature elevation of > 38 degrees will be eligible for inclusion and consented for     the study. Maternal blood will be drawn immediately, one hour later and at delivery. Amniotic     fluid will be aspirated from the pressure catheter; the first 1-2 cc will be discarded and     the remainder will be evaluated for gram stain, culture, glucose level, interleukin-6 (IL-6),     and proteomics. All placentas will be sent for routine pathologic examination. Cord blood     will be obtained at birth for routine studies. Both maternal and cord blood will be sent for     proteomic evaluation (defined). The patients with amniotic fluid that has a positive gram     stain and culture will be defined as the infected group, and the patients with amniotic fluid     that has a negative gram stain and culture will be defined as the uninfected group.     Differences in clinical presentation and laboratory assessments, including proteomics, will     be compared between the two groups to determine if there are any markers that might prove to     be useful in distinguishing between these two entities (epidural fever with and without     actual infection).   "
190037|NCT00326534|"     One study has suggested a connection between an infection with Rickettsia species and     sarcoidosis finding molecular evidence of rickettsial deoxyribonucleic acid (DNA) in two     patients. Another study found no antibodies in twenty Swedish patients with sarcoidosis.      This study will further enhance the subject by three different approaches in Danish patients.      The purpose of this study is to find serological and molecular evidence of an infection with     Rickettsia species in Danish patients with sarcoidosis.   "
190038|NCT00326560|"     Pterygium excision surgery involves excising the abnormal growth from the cornea and filling     the defect with a conjunctival (white of the eye) graft from the superior part of the eye.     This is the best method of pterygium excision but it is recognised that in 10-15% of cases it     will grow back (recurrence). Currently the investigators use small sutures to sew the graft     in place. Recently it has been described that glue can be used instead of the sutures. It has     been shown in one study that the patient discomfort is less and so is the surgical time. The     investigators want to confirm these findings and also compare the recurrence rate between the     two types of surgery. They plan to complete a prospective, randomised, control trial of 40     participants. Twenty will have traditional pterygium surgery with the conjunctival autograft     sutured. Twenty will have cut and paste surgery with Tisseel glue. The two groups of     participants will be compared for pain and discomfort, surgery time, and recurrence rate of     the pterygia.   "
190039|NCT00326573|"     The management of diabetes in adolescence presents significant difficulties due to     psychological and physiological factors. Blood glucose control deteriorates in this age group     and poor management threatens long-term health. Motivational Interviewing, a psychological     intervention designed to facilitate behaviour change, has recently been used with a small     group of teenagers, producing improved blood glucose control. To establish the impact of this     intervention and its key components, we plan to compare the outcome in several clinics over a     longer period of time in a larger number of adolescents selected at random to undergo     motivational interviewing or to act as a control group. If successful this approach has     potential to be incorporated into the routine clinical care of adolescents with diabetes.   "
190040|NCT00326586|"     This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant     Prostate Cancer.   "
190070|NCT00327015|"     The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe     and works better than taking either saxagliptin or metformin alone   "
190071|NCT00327028|"     The purpose of this study was evaluation the efficacy of antiepileptic drug phenytoin     (diphenine) in the treatment of bronchial asthma.   "
190042|NCT00326612|"     The investigators will conduct a randomized controlled trial comparing the use of nasal     midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute     seizure activity in children under the age of 18 years with epilepsy in the community     setting. The primary hypothesis is that nasal midazolam will be more effective and have     shorter seizure time compared to rectal diazepam in the community. The secondary hypotheses     are that patients treated with nasal midazolam will have fewer respiratory complications,     emergency department visits, and admissions.   "
190043|NCT00326625|"     Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under     the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone®     (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting     multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and     neuroprotective properties, which are believed to be of therapeutic value in ALS. The study     treatment duration is 1 year (52 weeks).   "
190044|NCT00326638|"     In this study we are comparing two forms of radiotherapy. This study is being done because it     is not clear at present time whether intensity modulated radiotherapy (IMRT) can reduce side     effects of radiotherapy compared to standard radiotherapy (called 3D-Conformal Radiotherapy).   "
190045|NCT00326651|"     Patients will use the Conception Kit in their home and fill out a 22 question questionnaire     in order to demonstrate their knowledge of the method of usage as described in the     instructions and on the website: www.conceptionkit.com.   "
190046|NCT00326664|"     This phase I trial is studying the side effects and best dose of AZD2171 in treating young     patients with recurrent, progressive, or refractory primary CNS tumors. AZD2171 may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking     blood flow to the tumor.   "
190047|NCT00326677|"     The Institute of Medicine has called for studies of indicated preventive interventions to     reduce the incidence of mental illness in persons already symptomatic but not yet presenting     with fully developed clinical syndromes.      The investigators' Advanced Center for Interventions and Services Research in Late Life Mood     Disorders has embraced the development and testing of preventive interventions as one of its     key objectives. The investigators propose to test the following hypotheses related to primary     prevention of major depressive episodes in old age, focusing on elderly patients who have     symptoms of emotional distress but who are not yet presenting with the full syndrome of a     major depressive episode.      Hypothesis 1: Problem solving therapy (PST) will be superior to an attention-only control     (dietary education) in lowering the two-year incidence of episodes of syndromal major     depression in already symptomatic elderly primary care patients.      Hypothesis 2: PST will also prevent higher levels of depressive symptoms and associated     disabilities, over a two-year period of follow-up.   "
190048|NCT00326690|"     The purpose of the present prospective, randomized study is to investigate the clinical     effectiveness of standardized left ventricular reconstruction surgery (LVR). In order to     standardize the procedure, the operation will be performed with the Blue Egg, manufactured by     BioVentrix, a subsidiary of CHF Technologies, Inc.   "
190061|NCT00326885|"     The purpose of this study is to determine whether the investigational drug catumaxomab is a     safe and effective treatment for recurrent symptomatic malignant ascites.   "
190109|NCT00333177|"     This study will determine the effectiveness of various combinations of psychosocial therapy     and risperidone treatment in improving work or school performance in people with     first-episode schizophrenia.   "
190110|NCT00333190|"     The purpose of this trial is to determine if selectively removing only a small subset of T     cells, called CD8+ T cells, is safe and if it can reduce the risk of graft versus host     disease (GVHD) without losing the anti-cancer effects.   "
190049|NCT00326703|"     Commercial aircraft passengers are exposed to atmospheric pressures ranging from the pressure     found at ground level to that encountered in the external environment at 8,000 feet. There is     some evidence in the medical literature that symptoms of acute mountain sickness can result     from ascent to altitudes of 6,300 to 10,000 feet by unacclimated persons during the first few     days following ascent, probably due to the hypoxia that results from breathing air at the     reduced ambient pressures at altitude. The logical hypothesis that follows is that exposure     to 8,000 feet could cause hypoxia sufficient to adversely affect the comfort and well being     of some commercial aircraft passengers on prolonged flights. There is insufficient data in     the literature to validate this hypothesis.      Exercise at sea level and at altitude reduces arterial oxygen levels. The logical hypothesis     that follows is that the combination of moderate exercise and exposure to altitude could     cause hypoxia sufficiently severe to adversely affect the comfort and well being of some     people and that the combined effect of exercise and altitude on comfort and well being is     greater than the effect of exercise or altitude alone. Again, there is insufficient evidence     in the literature to substantiate this possibility.      The purpose of this investigation is to test these hypotheses.   "
190050|NCT00326716|"     To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug     exposure during pregnancy compared to drug exposure in historical data in human     immunodeficiency virus (HIV) infected participants.   "
190051|NCT00326729|"     Fluid resuscitation in burn patients is associated with major macrocirculatory and     microcirculatory disturbances that have been poorly described. When done according to expert     opinions, it is now rare to encounter the death of a patient due to an inadequate fluid     resuscitation. Fluid resuscitation in burn patients is more opinion-based than     evidence-based. Although burn admission to an intensive care facility is relatively rare, the     burn patient is well suited to answer questions in the fluid resuscitation field because, as     opposed to other critically ill patients:        1. investigators do have a time ‘zero’ for burn patients; they know exactly when the insult          occurred;        2. apart from fluid resuscitation, the management of burn patients is uniform in the          investigators' unit and is done according to various protocols;        3. the burn population is more uniform than the septic population making confounders and          background noises less likely; and        4. as basic as it might sound, studying fluid resuscitation implies accomplishing a          significant one; burn patients are the category of critically ill patients receiving the          most important fluid resuscitation.      Studies that have addressed the question of fluid resuscitation in burn patients are quite     numerous. However, they are either under-powered, dealing with various interventions or     outcomes and sometimes of poor methodological quality.      Moving the investigators' focus from macrohemodynamic to microhemodynamic monitoring is now     essential and due to recent technological advances, severe impairments in microcirculatory     perfusion are now being recognized in various pathological states. What is now clear from     various studies is the fact that even with restoring ‘normal’ macrocirculatory parameters,     severe microcirculatory alterations can be seen.      This study is an integral part of a program aimed to explore different questions regarding     fluid resuscitation in burn patients. The aim is to characterize changes in fluid shift,     fluid accumulation, and vascular volumes after burn injury and also to study the effects of     an artificial colloid on different macrocirculatory and microcirculatory parameters. The     primary end points are:        1. fluid accumulation during the initial phase; and        2. short term effects of colloids on macrocirculatory and microcirculatory parameters.      This study will collect data on macro- and microcirculation derived from current monitoring     systems. Data (see below) will be collected at defined time points and before and after the     first two fluid challenges. If the fluid challenge occurs in a one hour time frame of a     defined time point, only one assessment will be done.        1. At defined time points: a set of data (see below) will be collected by the research team          at baseline, 6, 12, 18, 24, 36, 48 and 72 hours after burn injury. Baseline values will          be the ones obtained immediately after consent.        2. Fluid challenges: Burn patients often require additional fluid bolus to maintain          hemodynamic stability because of the following reasons: hypotension; decreased urine          output (less than 0.5 ml/kg/hour); uncorrected metabolic acidosis; rhabdomyolysis;          increasing hematocrit; or any other clinical reason according to the attending          physician.      In this study, the two first fluid challenges will be allocated according to a random list.     One bolus will be Pentaspan (500 ml) and the other will be a crystalloid solution (Ringer's     lactate 1000 ml). These two alternatives represent a true equipoise as they are equally     acceptable because choosing one of them depends on the preference of the attending physician.     Fluid challenges will be allocated using a randomised short block cross-over sequence.      The following parameters will be measured at a fixed time and before and after the fluid     challenges using different techniques.      Parameters:      Intrathoracic blood volume, extravascular lung water, total blood volume; extracellular     edema; intraventricular preload, ventricular volumes, diastolic function; cardiac output;     mixed venous saturation; oncotic pressure; microcirculatory assessment: number and diameter     of capillaries, proportion of perfusion, and flow velocities.      This is an observational, one-group study aimed at describing macrocirculation and     microcirculation parameters in a burn patient population. The investigators arbitrarily plan     to enroll 40 patients.   "
190052|NCT00326742|"     Aim of the project is to validate and functionally characterize the combined impact of     candidate genes and stress exposure on drinking in adolescents. Lifetime and recent stress     experiences and drinking are recorded in a sample of healthy young adults who are genotyped     for polymorphisms in candidate genes related to alcoholism. All participants undergo a     standard laboratory psychosocial stress test. Our hypothesis is that specific genes can be     identified which influence drinking by modulating stress response.   "
190053|NCT00326768|"     The objective of this trial is to assess the safety and efficacy of 52 weeks of open-label     treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg and     telmisartan 40 mg plus HCTZ 12.5 mg in patients with essential hypertension.   "
190054|NCT00326781|"     The purpose of this research study is to:        1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking          cessation; and        2. identify predictors of response to these alternate forms of nicotine replacement therapy          (NRT).   "
190055|NCT00326794|"     Background: Nonsurgical proximal humerus fracture is common, causing prolonged disability,     for which the time to begin rehabilitation is not well determined. We assessed the     feasibility and efficacy of early (within 3 days’after fracture) mobilisation of the shoulder     compared with conventional 3-week immobilization followed by physiotherapy.   "
190056|NCT00326807|"     This study assessed whether naltrexone, an opioid antagonist, might be effective in reducing     excessive gambling behavior in people who also drink heavily. The efficacy of naltrexone was     evaluated in a randomized, double-blind, placebo-controlled trial. Fifty-two subjects who had     significant problems with both gambling and alcohol received 11 weeks of either naltrexone or     placebo.   "
190058|NCT00326833|"     The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and     neurological disorders. Therefore, a proper and timely diagnosis and treatment is important.     The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of     vitamin B12 deficiency have increased since the 1980s. Consequently, the number of     individuals treated with vitamin B12 has increased significantly.      The objective of this project is to study the actual need for vitamin B12 injections in the     group of individuals who have already started treatment. In order to investigate this, the     investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12     deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they     will test if the individuals are able to absorb a physiological dose of vitamin B12 using a     recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the     vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be     able to divide the patients into three groups:        1. need life long injections with vitamin B12,        2. only need supplementations with a small dose of oral vitamin B12, and        3. no need for further vitamin B12 treatment.      The perspective is that the new information from this study might be used for a future     strategy for vitamin B12 treatment.   "
190059|NCT00326859|"     During their hospitalization, burn patients frequently require dressing changes that may be     painful. Deep analgesia and sedation are used but carry the risk of remnant somnolence and     other effects of anesthesia such as dizziness and nausea/vomiting. All these side effects may     delay refeeding after the procedure, ambulation and physical therapy. Drugs from the opioid     class are used to relieve pain during these procedures. Morphine with its slow onset and     remnant sedation is difficult to use in these patients. Pro-emetic properties and histamine     liberating effects also make this drug non optimal for iterative procedures. Fentanyl, a     synthetic opioid with shorter onset and lower incidence of nausea and vomiting, is the     standard drug used in dressing changes in burn patients. It is metabolized by hepatic     glucoconjugation. Remifentanil, a well known novel opioid, that has a unique metabolism     independent from renal or hepatic functions, is metabolized by a non specific esterase. It     has a very short half-life (3.5 minutes) and should therefore be administered as a continuous     infusion. The investigators hypothesized that the use of remifentanil for daily burn dressing     changes is associated with less pain during procedures and faster recovery. Studied patients     will be the ones requiring iterative dressing change procedures under sedation. The primary     endpoint will be the maximal pain during the procedure. Secondary endpoints will be: average     pain during and after the procedure; subjective sensation of comfort; total amount of opioids     received; times to feeding after the procedure and ambulation after the procedure; comfort of     the procedure according to the nurses; mobilisation according to the physical therapist; and     safety of the analgesia technique. The study will be conducted according to the     recommendations of the American Society of Anesthesiologists (ASA) that have been endorsed by     the Canadian Anaesthetists' Society (CAS). All patients who consent will fast for at least 6     hours before the procedure. The two following regimens will be compared: a bolus infusion of     fentanyl, starting with 1 µg/kg, followed by 0.5 µg/kg as needed every 5 to 10 minutes versus     continuous infusion of remifentanil adapted to ensure analgesia. The initial dose of     remifentanil will be 0.1 µg/kg/min to be adjusted between 0.05 µg/kg/min and 2 µg/kg/min. To     allow blinding during the study, patients will receive a double-blinded protocol with sham     (normal saline) in one arm. In other words: for each procedure, the patient will always     receive boluses, either of fentanyl or saline, and a perfusion, either of remifentanil or     saline. According to power calculations, 30 patients will be necessary to achieve the primary     end-points. The investigators plan to enroll 40 patients in the study to allow for some drop     outs and to increase their statistical power.   "
190060|NCT00326872|"     This phase II trial is studying how well AZD2171 works in treating patients with     neurofibromatosis type 1 and plexiform neurofibroma and/or neurofibroma near the spine.     AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor.   "
190062|NCT00326898|"     This randomized phase III trial studies sunitinib malate and sorafenib tosylate to see how     well they work compared to placebo in treating patients with kidney cancer that has been     removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to     the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor     cells that remain after surgery. It is not yet known whether sunitinib malate or sorafenib     tosylate is more effective than placebo in treating kidney cancer.   "
190063|NCT00326911|"     Eligible patients with metastatic pancreatic cancer will be treated with dual agent     monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with     gemcitabine   "
190064|NCT00326924|"     To determine if the age of blood transfused to new borns in the NICU setting has an impact on     their outcome.   "
190065|NCT00326950|"     The primary objective of this study is to determine the dose limiting toxicity and maximum     tolerated dose of E7389 in patients with solid tumors. The secondary objectives are to     investigate the pharmacokinetics, safety, estimated recommended dose, and anti-tumor effects     (in evaluable cases) of E7389 in patients with solid tumors.   "
190066|NCT00326963|"     This single arm study will evaluate the efficacy, safety and tolerability of a new     investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc     bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new     investigational PI will be administered according to the procedures of the early access     program in which the patient is enrolled. The anticipated time on study treatment is 3-12     months, and the target sample size is approximately 120 individuals.   "
190067|NCT00326976|"     The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size     following balloon catheterization for acute myocardial infarction.   "
190068|NCT00326989|"     Extracorporal shock wave therapy is performed prior to cell therapy for induction of     therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in     patients with chronic ischemic heart disease following anterior myocardial infarction.      Shock waves can induce growth factor expression in the ischemic myocardium and might augment     homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h     following shock wave therapy   "
190069|NCT00327002|"     Agents that increase HDL-C via reverse cholesterol transport could provide a new therapeutic     option for the prevention of atherosclerotic cardiovascular disease. The investigators     propose to investigate the effects of LY518674 on components that may likely affect     atherogenesis in patients with the metabolic syndrome including HDL-C metabolism and reverse     cholesterol transport pathways, the inflammatory response, and oxidative stress in human     subjects.      As an agonist of the nuclear peroxisome proliferator activated receptor (PPAR) alpha,     LY518674 may affect the transcription of genes that encode various proteins involved in     atherogenesis. This study will explore the consequences of altered transcription such as     changes in messenger ribonucleic acid (mRNA) and protein levels as well as protein activity.   "
190072|NCT00327041|"     Antiplatelet therapy plays a key role in the prevention of complications related to coronary     angioplasty and stenting (PCI) including procedure related myocardial damage. Aspirin and     clopidogrel are now universally prescribed in patients undergoing these procedures. However,     loading and maintenance doses have not been established and variation in individual response     is emerging. New tests to assess the effects of these drugs are being developed but have yet     to be incorporated into routine clinical practice. We will assess the effects of aspirin and     clopidogrel in a consecutive series of patients undergoing angioplasty using new assays which     can be carried out at the bedside. We will compare the results with alternative laboratory     based tests and look for an association between the results, peri-procedural myocardial     necrosis and subsequent cardiovascular events.   "
190073|NCT00327054|"     This is a pilot study.      The aim of the investigators' study is to evaluate the effectiveness of nigella sativa seed     in the treatment of dyslipidemia.      Dyslipidemia is a common risk factor for cardiovascular disease, the leading cause for     morbidity and mortality among patients.      Nigella sativa is an easily available and acceptable remedy to treat dyslipidemia and at a     low cost.      It is expected that by scientifically determining the effectiveness of this intervention it     will lead to its widespread use.      This will provide a low cost alternative to treat dyslipidemia.   "
190074|NCT00327067|"     Blood donors who have a low fingerstick hemoglobin level are usually deferred from donating.     A possible solution to the problem of repeated deferrals might be for Blood Banks to offer     donors with low hemoglobin levels oral iron supplements. To determine the feasibility of such     a program, this study will:        -  Determine the frequency of iron deficiency in first-time and repeat blood donors        -  Examine the effects of long-term blood donation on donor hemoglobin levels and iron          stores        -  Compare body iron stores in donors who have low hemoglobin values with that of donors          who have acceptable hemoglobin values at the time of donation        -  Determine what conditions other than iron deficiency lead to low hemoglobin levels in          blood donors        -  Determine the safety and effectiveness of giving oral iron tablets to donors with low          hemoglobin levels        -  Monitor the effect of oral iron administration on donor satisfaction and donor          retention.      First-time and repeat blood donors at the NIH Clinical Center Blood Bank 18 years of age and     older may be eligible for this study. Participants include prospective donors who have an     acceptable hemoglobin value at the time of donation and those whose hemoglobin level is     determined to be too low for donation.      All participants do the following:        -  Answer medical questions about their diet, health, and family history of blood          disorders.        -  Have blood samples drawn from their arm for testing blood cell counts, iron stores, and          other hemoglobin-related tests as appropriate.      Donors with low hemoglobin also:        -  Take iron supplements (ferrous sulfate) to replenish iron stores. (Donors who have          previously had unpleasant side effects from ferrous sulfate are offered ferrous          gluconate as an alternative.)        -  Undergo evaluation with medical screening and laboratory tests at the time of future          blood donations.   "
190075|NCT00327080|"     This study will examine how blood pressure in the lungs is controlled in healthy people,     people with HIV and people with HIV and pulmonary artery hypertension (high blood pressure in     the lungs, also called PAH). PAH sometimes develops in people with HIV, but it is not known     why this occurs or how best to treat it.      Healthy volunteers and patients with HIV infection who are 18 years of age or older may be     eligible for this study. All candidates are screened with a medical history, physical     examination, electrocardiogram (EKG), chest x-ray, echocardiogram and blood tests.     Participants undergo the following procedures:      All participants have a right heart catheterization and forearm blood flow study.        -  Catheterization study. A catheter (plastic tube) is placed in an arm vein and possibly          in an artery in the arm. Then a large catheter is passed through a vein in the groin,          neck or chest. Through this introducer catheter, another catheter is advanced into the          right side of the heart and to the pulmonary artery. A facemask is put in place to          measure the amount of nitric oxide produced by the lungs. Acetylcholine is infused          through the catheter and its effects on blood pressure in the lungs and on the amount of          nitric oxide exhaled is measured. After about 1 hour, the catheter and facemask are          removed and a new catheter is inserted through the introducer catheter into the          pulmonary artery. The subject is moved into an MRI scanner where blood flow is measured          after infusion of three different medications: acetylcholine (causes blood vessels to          expand and slows heart rate); sodium nitroprusside (causes blood vessels to expand and          increases blood flow to the heart); and L-NMMA (decreases blood flow by blocking          production of nitric oxide in cells lining the blood vessels).        -  Blood flow study. Small tubes are inserted into the artery of the patient's forearm.          These are used to infuse medicines and draw blood samples. Forearm blood flow is          measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a          rubber band device) placed around the forearm. When the cuffs are inflated, blood flows          into the arm, stretching the strain gauge, and the flow measurement is recorded. A small          lamp is positioned over the hand to measure the light reflected from the hand and blood          flow in the forearm. Blood samples are then drawn to measure blood counts and proteins          and other natural body chemicals. Then, forearm blood flow is measured after          administration of small doses of sodium nitroprusside, acetylcholine and L-NMMA. There          is a 20- to 30-minute rest period between injections of the different drugs.      In addition, HIV-infected patients with PAH undergo the following tests to determine the     cause of their PAH: CT scan of the lungs, pulmonary function tests, 6-minute walk test,     quality-of-life assessment, assessment of difficulty in breathing, exercise testing while     measuring oxygen breathed in and carbon dioxide breathed out, blood tests, monitoring of     oxygen saturation during sleep for 1 night and ventilation/perfusion scan. For the     ventilation/perfusion scan, the subject breathes in a small amount of radioactive aerosol     while images are obtained of the radioactivity as it enters the lungs, and then pictures of     the lungs are taken from multiple angles. Next, the patient receives an injection of tiny     particles of albumin (a protein) containing a small amount of radioactivity and pictures of     the lungs are taken that show the pattern of blood flow to the lungs.      Patients with HIV and PAH who may benefit from the investigational drug, sildenafil (commonly     known as Viagra), may continue to participate in the next stage of the study. They receive     the first dose of sildenafil after completing the forearm blood flow study. They continue the     drug for 16 weeks, returning to the clinic 1 week after the first dose and then every other     week to monitor the response to treatment and drug side effects. At the end of 16 weeks,     patients return to the clinic for a repeat evaluation, including blood tests, 6-minute walk     test, echocardiogram, right heart catheterization and forearm blood flow study.   "
190088|NCT00327249|"     AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple     myeloma. The first phase of the study is designed to determine a safe dose of imexon that can     be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of     the study is designed to provide additional safety data and to gain an understanding of     whether imexon can improve the outcome for patients with multiple myeloma   "
190089|NCT00327262|"     This study will investigate the efficacy and tolerability of a short (6 months) high dose     therapy followed by a standard dose compared to a continuous treatment with a standard dose     of imatinib (Glivec®) in pretreated Philadelphia chromosome- positive (Ph+)/BCR-ABL+ CML     patients in chronic phase.   "
190090|NCT00327275|"     To assess the effects of a 16-week individualized, intensive strength training program in     patients with rheumatoid arthritis. Primary and secondary outcomes include: strength and body     composition, function, disease activity, pain, quality of life.      We hypothesized that improvements would be seen in all of the above outcomes.   "
190076|NCT00327093|"     Primary Objective: This trial is elaborating a model for rapidly predicting (day 21) the     response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and bevacizumab) based     on biological markers and/or functional imaging. The response to treatment is evaluated by     the conventional method after 2 months (Response Evaluation Criteria in Solid Tumors [RECIST]     criteria).      Secondary Objectives:        1. This trial is also analyzing the correlation between the magnitude of response to          treatment at 2 months (stabilization or objective response, RECIST criteria) and that of          response observed after 6 months of treatment.        2. The organisational objective is to develop a tumour bank of metastatic colorectal          cancer.      Population: The population includes 252 male and female patients with metastatic colorectal     cancer justifying the use of cetuximab or bevacizumab, with no heart disease.      Techniques: Computed tomography (CT scan), functional imaging (ultrasound with SonoVue);     molecular imaging (positron emission tomography [PET] with fluorodeoxyglucose F18 [18-FDG]);     and biology and pathology on microbiopsy of liver metastasis are used.      Outcome Criteria: The primary outcome is response to treatment with monoclonal antibodies     according to RECIST criteria at two months.      Studied Factors:      Radiology:        1. CT scan: RECIST criteria (gold standard);        2. Ultrasound with SonoVue injection: 1 representative target (delay of contrast          appearance, peak of rising, curve of increase and decrease of the signal, area under the          curve, time of average transit).      Nuclear Medicine: PET scan and 18-FDG (standard uptake values [SUV])      Molecular Characterization of Tumors: p53 status; microsatellite instability (MSI) status;     expression of oncogenes; EGFR status; VEGF status; determination of FcgammaRIIIA     polymorphisms      Statistics:        1. Descriptive analyses;        2. Analysis of the appropriate threshold to measure: response to treatment by an ultrasound          with SonoVue and by PET scan; correlation between response predicted by the ultrasound          with SonoVue and the PET; conventional morphological CT at 2 months        3. Analysis of prognostic factors:             1. Evaluation of the role of each prognostic factor (pathology and imaging) on               response to treatment;             2. Multivariate analysis of prognostic factors;             3. Analysis of the prognostic power of early response at 2 months on the response               observed after 6 months of treatment.   "
190077|NCT00327106|"     The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture     surgery on the reduction of allogeneic red blood cell transfusion.   "
190078|NCT00327119|"     The primary objective of this study is to assess the effect of treatment with ABX-EGF on best     overall objective response rate by modified RECIST (confirmed complete or partial response)     in Japanese subjects with metastatic colorectal cancer.   "
190079|NCT00327132|"     1. The complete histological and molecular remission rate for antibiotics as 1st-line          therapy for Hp-positive early-stage gastric lg- and hg-MALT lymphoma        2. The durability of complete histological remission after antibiotics        3. The usefulness of pattern of NF-kB and BCL-10 by IHC staining in prospectively          predicting the Hp-dependence of gastric lg- and hg-MALT lymphoma        4. The frequency of t(11;18) translocation in gastric lg- and hg-MALT lymphoma in Taiwan.        5. The association between the CYP2C18/19 genetic polymorphisms and eradication of Hp          infection after antibiotics.   "
190080|NCT00327145|"     This study is designed to provide additional efficacy and safety data for a treatment     strategy based on the combination valsartan with amlodipine in hypertensive patients     previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will     be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg     with possible addition of HCTZ   "
190081|NCT00327158|"     The purpose of the study is to see if there is a difference in the amount of fat droplets     reaching the heart during surgery between the standard reamer currently used and a new reamer     system which is expected to reduce the fat going into the blood, via an intraoperative     echocardiography done through the food pipe.   "
190082|NCT00327171|"     This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma     receiving aflibercept.      The primary objective was to compare the objective response rate of Aflibercept     (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered     intravenously (IV) every 2 weeks with historical control in participants with advanced     ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant     to platinum and topotecan and/or liposomal doxorubicin.      The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential     biological and pharmacogenomic markers of study drug activity, and health-related quality of     life.      This study employed an Independent Review Committee (IRC) for radiological tumor assessments.     For all tumor assessment-related efficacy variables, two analyses were performed: the primary     analysis was based on Independent Review Committee (IRC) reviewed data and the secondary     analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the     IRC reviewed data is reported for this study.   "
190083|NCT00327184|"     The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two     doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants     (at 3 & 5m) compared to NeisVac-C™ given with Infanrix™ hexa.      The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and     reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m     of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior     to the administration of the booster doses. The Protocol Posting has been updated in order to     comply with the FDA Amendment Act, Sep 2007.   "
190084|NCT00327197|"     To evaluate and compare the expression and change in expression of key severe asthma targets     at baseline in mile to moderate asthmatics vs. severe asthmatic subjects.      To evaluate and compare the airway pathology at baseline and changes in airway pathology in     relation to asthma severity.   "
190085|NCT00327210|"     BGATHome is an interactive, web-based training program designed to improve the ability of     adults with Type 1 Diabetes to recognize, predict, treat, and avoid extreme blood glucose     (BG) events. It was developed at the University of Virginia over the past 20 years with     funding from the National Institutes of Health and the American Diabetes Association.     BGATHome provides important knowledge about personal insulin use, food, and activity regimens     that influence BG levels. Users of this program will learn to monitor and recognize the cues     that signal hyper and hypoglycemic events, and enhance their ability to control these     fluctuations.   "
190086|NCT00327223|"     AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and     pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three     weeks. The objective of the study is to determine the maximally tolerated dose, the     pharmacokinetics, and the toxicity of the drug on the designated schedule.   "
190087|NCT00327236|"     The investigators believe that T cells, cells that are a part of the immune system, are what     are causing the neurological problems while also attacking tumor cells. This protocol studies     the clinical status of patients with paraneoplastic neurological disorder (PND) as well as     their blood to understand the relationship between their neurological disease, their cancer,     and their immune system.   "
190111|NCT00333203|"     The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating     Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular     membrane and vitrectomy.   "
190091|NCT00327288|"     Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously     treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer.     Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for     these cancers. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3     week cycle. The objective of the protocol is to determine the highest dose of imexon which     can be given with a full dose of docetaxel, and to provide information to enable the design     of a future study focused on one or more specific cancer types.   "
190092|NCT00327301|"     Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy     is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the     final end point in blinding diseases of the optic nerve such as glaucoma. It is known that     neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies the     investigators could demonstrate that the process of apoptosis is reflected in circulating     leukocytes by different parameters, like differential mRNA expression and an increased     fragmentation of the DNA. Such alterations point out a relationship between cellular stress     and apoptotic events.      Based on the results of mRNA-expression the investigators also expect alterations on the     protein level.      This study is, therefore, designed to characterize the proteome related to the proteins     involved in cell death related pathways.      Thus, the expression pattern of several proteins in leukocytes from patients with primary     open angle glaucoma will be analyzed by techniques like Western-blot and tandem mass     spectrometry. These samples will be compared with samples from healthy controls. In addition,     they will also be compared with samples from patients with Parkinson's disease. Since     glaucoma is a neurodegenerative disease, these patients will be included as positive controls     in this study.   "
190093|NCT00327314|"     The protocol aims at reducing transplant toxicity and mortality in patients with multiple     myeloma.   "
190094|NCT00327327|"     AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug     imexon in combination with an approved drug, gemcitabine, for the treatment of patients with     previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and     gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the     highest doses of the two drugs that can be safely combined together.   "
190095|NCT00327340|"     This study is for patients with cancer of the prostate gland that has metastasized or spread     outside the prostate to other parts of the body. Patients have already been treated with a     drug called docetaxel or Taxotere® (with or without the addition of a steroid called     prednisone) some time in the recent past. They either did not respond to this therapy or     responded to this therapy, but now the cancer is progressing (growing larger or has spread to     other areas of the body).      Custirsen (OGX-011) is an experimental drug that has been shown to increase the effectiveness     of chemotherapy in several kinds of tumors, including prostate cancer.      Both docetaxel and mitoxantrone have anticancer activity in prostate and are approved by     Health Canada and the Food and Drug Administration for the treatment of patients with     prostate cancer.   "
190096|NCT00327353|"     Effect of inhaled drugs administered as dry powder is not only dependent on drug efficacy but     also on technical properties of the inhalers. Different inhalers have different internal     resistances and therefore it is expected that patients with limited airflow may have     different exposure rates of drugs delivered from different devices   "
190097|NCT00327366|"     The study investigated whether bright artificial light may influence menstrual cycle and     ovulation conclusively, and what underlying hormonal changes for this effect are.   "
190098|NCT00327379|"     The objective of this study is to evaluate the safety and efficacy of aprotinin as compared     to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective     spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation   "
190099|NCT00333047|"     Therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging     survival and improving the quality of life. The objective of this trial is to assess if an     initial chemotherapy followed by an endocrine therapy leads to a longer disease-free interval     as compared to chemotherapy alone.   "
190100|NCT00333060|"     The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic     solution and drug-free solution to safely and effectively prevent or delay the progression of     nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina     repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies     involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the     lens.   "
190101|NCT00333073|"     To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed     (stress and urge) urinary incontinence after 12 months follow up period   "
190102|NCT00333086|"     Currently available treatments for endometrial cancer are associated with limited efficacy     and significant toxicity. This study will assess the safety and efficacy of letrozole, an     aromatase inhibitor, on endometrial cancer.   "
190103|NCT00333099|"     The aim of this study is to investigate if enteral immunonutrition of head and neck or     esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet     [Impact (R), Novartis] versus a standard enteral nutrition (control, Novartis), could improve     clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status,     and life quality parameters.   "
190104|NCT00333112|"     A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of     residual OAB symptoms in men.   "
190105|NCT00333125|"     The purpose of this study is to compare the intraocular pressure (IOP)-lowering efficacy and     safety of two combination products in patients with open-angle glaucoma or ocular     hypertension.   "
190106|NCT00333138|"     This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720     in patients with relapsing multiple sclerosis.   "
190107|NCT00333151|"     This trial is conducted in the United States of America (USA) and Canada. This trial is     designed to show the effect of treatment with liraglutide when added to existing     rosiglitazone and metformin combination therapy and to compare it with the effects of therapy     with rosiglitazone and metformin alone.   "
190134|NCT00334178|"     The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with     placebo in prophylactic monotherapy treatment of migraine headache.   "
190112|NCT00333216|"     The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15     mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry)     age-related macular degeneration in patients who are at risk for progressing to exudative     (wet) age-related macular degeneration.   "
190113|NCT00333229|"     Breast cancer and osteoporosis are two of the most frequent diseases in women. Estrogen may     be associated with bone loss and the risk of breast cancer because of its potent effects on     the mitotic activity of breast epithelium and on bone turnover.      This study is will assess the safety and efficacy of Zoledronic acid 4 mg, given every 3     months over 24 months, in improving bone mineral density in premenopausal women with hormone     receptor negative breast cancer and adjuvant chemotherapeutic treatment compared to placebo.      This study is not recruiting patients in the United States.   "
190114|NCT00333242|"     In the proposed study, we will build upon our previous studies validating and characterizing     hyperalgesia in MM samples to explore it's underlying mechanism from a pharmacological     perspective. Utilizing a double-blind, placebo-controlled designs, the proposed work will     evaluate the ability of dextromethorphan , an N-methyl-D-aspartate (NMDA)-antagonists to     diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by     MM patients. Specifically, in a sample of MM patients, dextromethorphan, theorized to     interfere with the development of opioid-induced hyperalgesia will be evaluated for its     ability to ameliorate or diminish the opioid-induced hyperalgesia in these patients as     reflected by changes on pain threshold and tolerance to both cold-pressor and electrical     pain, at peak and trough methadone blood levels. The results of this work will not only     provide pharmacologic insight into the mechanisms underlying poor pain tolerance in this     at-risk population, but also direction for the medical management of pain complicated by     opioid-induced hyperalgesia.   "
190115|NCT00333255|"     The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension,     0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating     inflammation in the eye.   "
190116|NCT00333268|"     The purpose of this study is to determine the safety and efficacy of Next Generation     Ophthalmic Irrigating Solution (NGOIS) compared to BSS Plus for use during cataract     extraction and intra-ocular lens (IOL) implantation.   "
190118|NCT00333294|"     The objective of this study is to determine wether the ZD1839 associated with a radiotherapy,     before the beginning of chemotherapy is effective in the treatment of your disease and to     evaluate the tolerance of these treatments.   "
190119|NCT00333307|"     The purpose of this study is to determine whether different doses of recombinant human     relaxin is safe when given to women with severe preeclampsia   "
190120|NCT00333320|"     The purpose of this study is to determine whether brief periods of ischemia performed just at     the time of reperfusion -postconditioning- can reduce coronary endothelial dysfunction and     infarct size in humans   "
190121|NCT00333333|"     This research project is studying the causes for low platelet levels in preterm infants.     Platelets are a component of blood that helps with clotting. The purpose of this study is to     determine whether the cause for low platelet levels is the same in infants who are born to     mothers with preeclampsia and infants who are small for gestational age.   "
190122|NCT00333346|"     The aim of this study is to compare the administration of 1 unit dose of 100 mg tramadol     intravenously versus multiple smaller dosages of tramadol during the first 6 hours     post-operatively and to investigate the time course and accuracy of pain relief versus the     onset and duration of side-effects.   "
190123|NCT00333359|"     The primary objective of this trial is to assess the long-term safety and efficacy of XP13512     (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless     Legs Syndrome (RLS).   "
190124|NCT00333372|"     To Evaluate the efficacy of Z-338 in subjects with Functional Dyspepsia, focusing on the     assessment of subjective symptoms in order to further determine the optimal dosage and     efficacy parameters for PhaseIII clinical trials.   "
190125|NCT00334061|"     This clinical evaluation is a prospective, single-arm, multi-center trial.      The purpose of this clinical evaluation is to assess the safety and effectiveness of the     Penumbra System in the revascularization of patients presenting with acute ischemic stroke     secondary to intracranial, large vessel, occlusive disease.   "
190126|NCT00334074|"     The purpose of this trial is to to determine the safety and effectiveness of therapeutic     combination - Clofarabine and Cytarabine for the treatment of AML and MDS.   "
190127|NCT00334087|"     -  200 children between ages 36 to 48 months will be invited for a regular dental          examination        -  Parameters to be investigated             1. Pregnancy history             2. Birth outcome             3. Child's general health             4. Feeding habits             5. Oral hygiene habits             6. Dmft caries index             7. Congenital enamel defects   "
190128|NCT00334100|"     The purpose of the study is to determine whether treadmill training is safe and beneficial in     patients with walking difficulty because of multiple sclerosis.   "
190129|NCT00334113|"     The overarching objective of this study is to develop an innovative strategy to address the     problems of obesity and diabetes by promoting exercise adoption. An automated telephone     intervention will be developed that can be used to enhance exercise adoption over a twelve     month period in a population of overweight or obese veterans with Type 2 diabetes.   "
190130|NCT00334126|"     The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of     the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to     placebo in patients who are acutely ill with symptoms of schizophrenia.   "
190131|NCT00334139|"     Bisphosphonates have been used extensively in the treatment and the prevention of skeletal     complications associated with bone metastases in patients with breast cancer and prostate     cancer.      The purpose of this study is to assess the effect of zoledronic acid patients with prostate     cancer or breast cancer and bone metastasis.   "
190132|NCT00334152|"     This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will     significantly decrease the number of patients who experience nausea and vomiting after     surgery.   "
190133|NCT00334165|"     The aim is to investigate whether auricular acupuncture is superior to sham acupuncture in     relief of acute pain and in reduction of analgesics in patients during total hip arthroplasty   "
190135|NCT00334191|"     Many patients develop kidney failure after cardiac surgery. Although this kidney failure can     usually be treated effectively, a longer stay in intensive care is often required. While many     patients suffer no long term ill effects after developing post-operative kidney failure, some     require long term kidney dialysis. We also know that patients who develop post-operative     kidney failure are much more likely to die before they leave hospital.      Why some people develop kidney failure after cardiac surgery is not known. However, doctors     suspect that the process of cardiopulmonary bypass (where the functions of the heart and     lungs are taken over by a machine during the operation, to allow the surgeon to operate)     overactivates some of the same mechanisms the body uses to defend itself against severe     infection.      Many of the cell changes by which severe infection causes kidney failure also occur after     cardiopulmonary bypass. One of the main overactive defence mechanisms is the release of     highly toxic compounds derived from oxygen - a process called 'oxidative stress'.      The investigators believe that sodium bicarbonate might reduce the oxidative stress, which     occurs during cardiac surgery, and so prevent or decrease the kidney failure, which occurs in     many patients.      The investigators hope to give sodium bicarbonate (in similar doses to those used safely for     treatment of acidosis) to patients during, and for 24 hours after cardiac surgery, and to     compare the effects with patients who have not had sodium bicarbonate. The drug, or a     placebo, will be given through the drip, which is present in all cardiac surgery patients.     Whether a particular patient receives the drug or placebo will be decided at random, and     neither the patient nor the investigators will know which has been given. We will measure     kidney function before and after the operation using the standard blood tests.      The investigators will also take four 20ml samples of blood, spaced before, during, and after     the operation, from the arterial catheter routinely inserted in every patient. This blood     would be used to measure oxidative stress, and also some of the proteins inside the blood     cells, which are responsible for creating the toxic oxygen compounds. In this way we will     discover not only the effect of sodium bicarbonate, but also the mechanism of that effect.      Sodium bicarbonate is commonly used to treat metabolic acidosis in severe renal disease,     circulatory insufficiency due to shock or severe dehydration and has been shown to be an     effective drug in preventing contrast-induced nephropathy.      Sodium bicarbonate is considered to be safe in the setting of intensive care treatment and is     often used in the treatment of patients with metabolic acidosis without any discernible     adverse clinical effects.      This is a pilot study. If the drug proves effective in this context, further studies on a     larger scale would be required to justify its general use.      There will be no extra risk to a patient who participates in the study, and no discomfort     other than that normally associated with cardiac surgery.      Informed consent will be obtained from the patient prior to the operation by one of the     investigators or the ICU research nurse. The clinical care of a patient who does not consent     for any reason will not be affected.   "
190136|NCT00334204|"     The kidneys are highly vascular organs and any trauma or surgery poses risk of severe     bleeding. Platelet function is an integral part of the blood clotting during the initial,     so-called vascular phase. So far no universally accepted, easy test has been available to     measure platelet functions. Renal failure is a condition generally associated with bleeding     due to platelet dysfunctions. This study is exploring the utility of a novel platelet     function test, called Platelet Function Analyser-100 to predict bleed after percutaneous     kidney biopsy. Platelet Function Analyser-100 will be measure before kidney biopsy along with     routine blood tests. Subjects will undergo renal ultrasound before and after renal biopsy to     verify post-biopsy bleeding events.   "
190137|NCT00334217|"     This study is for the purpose of determining whether cognitive remediation may improve     cognition and treatment response in patients entering substance abuse day treatment   "
190138|NCT00334230|"     This study, conducted in collaboration with the National Rehabilitation Hospital (NRH) in     Washington, D.C., will look at changes in brain activation and brain responses that occur     with gait (walking) training. Brain images and responses of healthy subjects are compared     with those of patients.      Healthy normal volunteers and people who have had a stroke within 3 months of starting the     study may be eligible for this study. Candidates must be between 18 and 80 years of age, and     patients must participate in NRH's walking study.      Stroke patients participate in all three study sessions described below. The first session     takes place before patients start the NRH walking training study, the second session takes     place at completion of the NRH walking study, and the third session takes place 3 months     after completing the NRH study. Healthy control subjects complete only the procedures in     session 3.      Session 1      Day 1: Neurological examination and questionnaire to evaluate memory and attention.      Day 2: Motor testing with transcranial magnetic stimulation (TMS). For this test, a wire coil     is held on the subject's scalp. A brief electrical current passes through the coil, creating     a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked     to tense certain muscles slightly or perform other simple actions to help position the coil     properly. The stimulation may cause a twitch in the leg muscles, and the subject may hear a     click and feel a pulling sensation on the skin under the coil.      Session 2      Day 1: Functional MRI (fMRI). MRI uses a magnetic field and radio waves to produce images of     body tissues and organs. The subject lies on a table that can slide in and out of the scanner     (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur     during the scanning process. Scanning time varies from 20 minutes to 3 hours, with most scans     lasting 45 and 90 minutes. Subjects may be asked to lie still for up to a few minutes at a     time and to perform movements of their foot.      Day 2: motor testing with TMS.      Session 3      Day 1: fMRI      Day 2: motor testing with TMS   "
190139|NCT00334243|"     Many infertile patients have a decreased chance of becoming pregnant when using in vitro     fertilization (IVF). For these patients, many different treatments are available, but none of     them have been shown to be better than the others. We are testing which of three different     treatments are better than the others. Patients who are expected to have a decreased response     to ovarian stimulation will be randomized to either a microflare protocol, an antagonist     protocol, or a demi-halt protocol.   "
190140|NCT00334256|"     To study the pharmacokinetic properties, safety and viral resistance pattern of the     combination of tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant     women and their newborns, with a view to prevention of mother-to-child transmission (PMTCT)     of HIV-1 in Africa and Asia.   "
190141|NCT00334269|"     The purpose of this study is to develop an effective intervention strategy to prevent &     reduce obesity among a high risk cohort of Aboriginal families.   "
190142|NCT00334282|"     To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally     advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible     patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib     once daily or matching placebo. The study treatment will continue until patients experience     disease progression, unacceptable toxicity or death. Primary objective of the study is to     evaluate and compare the two treatment arms for progression-free survival. Principal     secondary objective is to evaluate and compare the two treatment arms with respect to overall     survival. Other objectives are overall response rate [complete response (CR) + partial     response (PR)], rate of CR + PR + 6 months stable disease, and the incidence, severity and     causality of adverse events and serious adverse events. Safety and efficacy assessments will     be regularly performed on all patients. An Independent Data Monitoring Committee will be     established to monitor safety during the course of the study and to evaluate interim efficacy     data on overall survival.   "
190143|NCT00334295|"     The purpose of this study is to determine the efficacy of a monthly administration of     Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of     the clinical tumour response after 3 injections.   "
190144|NCT00334308|"     The Question posed is: Does an barley protein concentrate have health benefits similar to     those demonstrated for soy protein foods which would justify the use of the non-fiber     components of barley as functional food ingredients? Hypotheses: 1. Cholesterol Lowering:     There is good evidence indicating that soy protein lowers serum cholesterol levels. The     evidence was strong enough for a health claim for coronary heart disease risk reduction to be     approved by the FDA. In addition, we have found that wheat gluten significantly reduced serum     triglyceride levels. However, there is a need to assess the possible health benefits other     vegetable protein sources. Barley is grown in relatively large amounts in Canada and barley     protein would be a readily available vegetable protein source if health attributes could be     ascribed to it. In addition other components of barley, including plant sterols and     phenolics, may have hypocholesterolemic and antioxidant properties. 2. Antioxidant: In     addition to cholesterol-lowering and possibly of equal importance in terms of prevention of     cardiovascular and other chronic diseases, the barley phenolics associated with barley     protein and may have added benefits as antioxidants. 3. Markers of Inflammation: Barley     components are considered to be hypoallergenic. Hence their use in the cosmetic industry.     Auto-immune and inflammatory responses are associated with increased CHD risk. Barley protein     consumption may therefore reduce the levels of the pro-inflammatory cytokines; and the acute     phase proteins. 4. Arterial Dilatation: Barley proteins may also have beneficial effects on     vascular reactivity which may reduce CHD risk on account of their higher arginine:lysine     ratio. Arginine enhances nitric oxide synthesis associated with endothelial relaxation and     arterial dilatation. Barley may therefore increase pulmonary nitric oxide levels.   "
190145|NCT00334321|"     This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in     post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.   "
190146|NCT00334334|"     Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of     the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus     influenzae type b.   "
190147|NCT00334347|"     To compare the time to response, response rates, remission rates, and side effects in Bipolar     Disorder inpatients treated with Depakote ER or Depakote DR for acute mania or mixed mania.   "
190196|NCT00334984|"     RATIONALE: Glutamine may help prevent mucositis, or mouth sores, in patients receiving     chemotherapy for sarcoma. It is not yet known whether glutamine is more effective than a     placebo in preventing mucositis in patients receiving chemotherapy for sarcoma.      PURPOSE: This randomized clinical trial is studying glutamine to see how well it works     compared to a placebo in preventing oral mucositis in patients receiving chemotherapy for     sarcoma.   "
190148|NCT00334360|"     The purpose of this research is to determine if the combination of buspirone and     dexmedetomidine are effective as a treatment to induce therapeutic hypothermia.      The design of the study includes four study days done in random order. The days are as     follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a     computer-controlled IV infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the     combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6     ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic     technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted     into the other arm for drug administration.      Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting     the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air     warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and     lower-body will individually be maintained at the designated skin temperature. Lactated     Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to     decrease tympanic membrane temperature ≈1.5°C/h. Fluid will be administered as long as oxygen     consumption or electromyographic intensity (see below) continues to increase or a total of 5     liters of fluid is given. Heart rate will be measured continuously using an     electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at     the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of     the baseline), the study will stop and the volunteer will be re-warmed immediately.   "
190149|NCT00334373|"     The purpose of this trial is to compare post-conditioning to standard angioplasty (50/50     chance) in patients who present with an acute heart attack and are taken directly for an     angioplasty procedure. Post conditioning is a procedure that involves balloon inflation     followed by deflation in a series of cycles that appears to show (based on early data) that     it can decrease the amount of damage to the heart muscle as compared to standard angioplasty     procedures.      Hypothesis: For Subjects undergoing direct PCI for STEMI, post conditioning with cycles of     balloon inflation/deflation within the first minute following the re-establishment of     coronary blood blow, will decrease the amount of irreversible myocardial damage assessed by     delayed enhancement contrast CMR.   "
190150|NCT00334386|"     Primary objective:To demonstrate the no-inferiority in efficacy of treatment with     Torsemide-PR in relation to Torsemide-IR in patients with mild and/or moderate hypertension.      Secondary objectives: To evaluate the safety and tolerability of Torsemide-PR.   "
190152|NCT00334412|"     Combination therapy of caspofungin and amphotericin B could be a useful treatment option in     invasive fungal disease, but before it can be routinely recommended; carefully controlled and     well-designed randomized clinical trials are needed.   "
190153|NCT00334425|"     To evaluate the effect of LH-activity supplementation during the early follicular phase in     GnRHa down-regulated women undergoing IVF in terms of S-Estradiol levels on hCG day by     comparing different combinations with HP-HMG and r-FSH.   "
190154|NCT00334438|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as rituximab, and radiolabeled monoclonal     antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them without harming normal cells.     Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more     cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     given together with rituximab and yttrium Y 90 ibritumomab tiuxetan in treating patients with     relapsed or refractory low-grade, follicular, or mantle cell non-Hodgkin's lymphoma.   "
190155|NCT00334451|"     The RAPID-RF Registry aims to characterize LATITUDE® Patient Management's alert feature:     LATITUDE Active Monitoring™ by evaluating type and frequency of alert notifications and     alert-related medical interventions. This registry will also assess clinical outcomes     including quality of life and New York Heart Association Class changes over time, mortality,     hospitalizations and heart failure-related event rates.   "
190156|NCT00334464|"     Anticoagulation with warfarin is a common and potentially hazardous therapeutic intervention.     It is a leading cause of iatrogenic bleeding events and, hence, of malpractice claims. There     are no good alternatives presently for warfarin anticoagulation, and even when alternatives     become available (i.e., ximelagatran), cost, labeling, and experience (outcomes-related)     issues will continue to favor an extensive and ongoing use of warfarin. If the present study     is able to confirm an advantage for a genotype-driven algorithm, in terms of improved     efficiency, therapeutic efficacy, and, especially, safety, then a pharmacogenetics approach     to warfarin dosing can be recommended as the basis for an Intermountain Health Care     (IHC)-wide quality improvement initiative that should improve patient outcomes, reduce     resource use (costs of achieving safe and therapeutic anticoagulation), and reduce adverse     clinical events. COUMA-GEN is a prospective, randomized study of patients who are to begin     chronic warfarin therapy for specific, qualifying clinical reasons (i.e., atrial fibrillation     (AF), deep vein thrombosis (DVT), or post-orthopedic surgery prophylaxis). Qualifying     patients will be consented and randomized to an individualized, genotype-based     warfarin-dosing regimen or to standard care (without knowledge of genotype). In each study     arm, a predicted maintenance dose will be determined. All patients will receive a baseline     International Normalized Ratio (INR). For patients in all 3 entry strata, a starting dose of     warfarin that is twice the assigned daily maintenance dose (according to the specific     treatment arm) will be prescribed on the first and second days, and then the dose will revert     to the assigned maintenance dose.   "
190157|NCT00334477|"     The purpose of this study is to check the safety and efficacy of a pde5 inhibitor, tadalafil,     is a special group of patients: Renal chronic patients in hemodialysis treatment.   "
190168|NCT00334620|"     The study aimed to investigate effects of radon (plus CO2) baths on RA in contrast to     artificial CO2 baths in RA rehabilitation.      134 patients of an in-patient rehabilitative programme were randomly assigned to the groups.     Outcomes were limitations in occupational context/ daily living (main outcome), pain,     medication, etc. measured before start, after end of treatment, and up to a year thereafter.      Superiority of radon treatment was found regarding reduced limitations in daily living until     12 months after end of treatment. Steroid consumption and NSAIDs were significantly reduced.   "
190158|NCT00334490|"     Post-operative pulmonary hypertension is a risk factor for right ventricular failure and an     increasing cause of morbidity and mortality in patients undergoing high-risk cardiac surgery.     Several treatments have been used to treat and reduce post operative pulmonary hypertension.     Unfortunately none of these treatments are approved for use in this condition and only one     (inhaled nitric oxide) is specific enough to pulmonary hypertension to not cause dangerous     low blood pressure in the rest of the body. Sadly, inhaled nitric oxide is difficult and     expensive to use, and can cause lung damage. Sildenafil citrate is quite specific to the lung     vessels, is easy to administer and does not easily cause low blood pressure in other areas of     the body. We hypothesize that oral sildenafil 12.5mg will decrease the baseline (pre-dose)     mPAP by at least 20% compared with a placebo.   "
190159|NCT00334503|"     The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in     patients with Type2 Diabetes Mellitus treated with Biguanide.   "
190160|NCT00334516|"     This study will test whether primary lateral sclerosis (PLS) and amyotrophic lateral     sclerosis (ALS) affect parts of the brain responsible for thinking, planning, memory and     emotion.      Healthy volunteers 18 years of age and older and patients with PLS and ALS may be eligible     for this study.      Participants undergo the following procedures:        -  Rating motor function: Subjects are asked to contract certain muscles in the face, arms          and legs, to tap their finger on a keyboard rapidly, to walk 20 feet, and to read a          paragraph out loud.        -  Electroencephalography (EEG): The electrical activity of the brain (brain waves) is          recorded while subjects tap their finger very slowly. For this test, electrodes are          placed on the scalp using a cap or an adhesive substance. A conductive gel is used to          fill the space between the electrodes and the scalp to ensure good contact.        -  Surface electromyography (EMG): The electrical activity of the muscles is measured.          Electrodes filled with a conductive gel are taped to the skin over the muscle tested.        -  Neuropsychological testing: Testing may include questionnaires, pen-and-paper or          computerized tests, and motor tasks.        -  Magnetic resonance imaging (MRI): MRI uses a strong magnetic field and radio waves to          produce images of the brain. The subject lies on a table that slides into the scanner.          Scanning time varies from 20 minutes to 3 hours, with most scans lasting 45-90 minutes.   "
190186|NCT00334854|"     RATIONALE: Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination     chemotherapy with or without radiation therapy before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after     surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase III trial is studying how well giving ifosfamide and doxorubicin,     radiation therapy, and/or surgery works in treating young patients with localized soft tissue     sarcoma.   "
190161|NCT00334529|"     This study will determine if oseltamivir (Tamiflu(Registered Trademark)) is safe and     effective given less frequently than the currently prescribed dose of twice a day for 5 days     to people who have the flu, and once a day for up to 6 weeks in people who have been exposed     to someone else with flu and want to prevent getting it themselves. This study will see if     the drug can be given once every other day instead of daily if given with another medication     called probenecid (Benemid(Registered Trademark) or Probalan(Registered Trademark)).      Healthy people 18 years of age and older may be eligible for this study. Candidates are     screened with a medical history, physical examination, and blood and urine tests.      Participants are randomly assigned to one of the following regimens for 2 weeks: 1) 75     milligrams (mg) of oseltamivir once a day; 2) 75 mg of oseltamivir once every other day plus     500 mg probenecid four times a day; or 3) 75 mg of oseltamivir once every other day plus 500     mg probenecid twice a day. All medications are taken by mouth. On study day 0, subjects have     the following baseline procedures: measurement of vital signs, review of medical and     medication history, physical examination, blood draw and urine test. They also receive the     first dose of oseltamivir or oseltamivir and probenecid. In addition, they undergo the     following procedures as follows:        -  Days 1 and 4: Vital signs; review of clinical symptoms, side effects and medications          taken; urine testing and blood draw.        -  Day 8: Same as day 1 plus count of study medication.        -  Day 14: Same as day 8 plus pharmacokinetic study to measure the amount of oseltamivir          and probenecid in the blood. For this test, a catheter is inserted into an arm vein and          blood samples are collected through the catheter before taking the study medications, at          the time the medications are taken, and again at 15 minutes, 30 minutes, 45 minutes and          1, 1.5, 2, 4, 8 and 12 hours after the medication is taken. The catheter is then          removed. This is the last day to take the study medication.        -  Day 15: Blood draw for 24-hour (post medication) blood sample.        -  Day 16: Blood draw for 48-hour (post medication) blood sample.        -  Days 21 and 28: Same as day 1.   "
190162|NCT00334542|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of simvastatin may keep cancer from coming back in women who are at     high risk for a new breast cancer after undergoing surgery for ductal carcinoma in situ or     stage I, stage II, or stage III breast cancer.      PURPOSE: This phase II trial is studying how well simvastatin works in preventing a new     breast cancer in women at high risk for a new breast cancer after undergoing surgery for     ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.   "
190163|NCT00334555|"     This study is designed to try to find the best method of partner notification and treatment     for partners of women with trichomonas   "
190164|NCT00334568|"     Clinical features in patients with the familial early onset forms and the sporadic forms of     Alzheimers disease are similar, although the course of deterioration may be different. It     would be very informative to examine the drug response of patients with Alzheimers disease by     a certain genotype to find evidence favouring genotype-specific drug responses that may     indicate genetically defined phenotypic differences in alzheimers disease.   "
190165|NCT00334581|"     Primary objective:        -  To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in          hypertensive patients with diabetes and microalbuminuria.      Secondary objectives:        -  To determine how well irbesartan 300mg is tolerated versus 150mg        -  To determine the percentage of patients reaching the blood pressure target of 130/80          mmHg   "
190166|NCT00334594|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells     that remain after surgery.      PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium     together with cisplatin followed by surgery with or without radiation therapy works in     treating patients with malignant pleural mesothelioma.   "
190167|NCT00334607|"     The aim of this this study is to confirm absence of immune interference between HRV vaccine     and routine infant vaccinations currently in use in the USA.   "
190172|NCT00334672|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of     hemophagocytic lymphohistiocytosis cells, either by killing the cells or by stopping them     from dividing. Giving more than one drug (combination chemotherapy) may kill more     hemophagocytic lymphohistiocytosis cells. A donor stem cell transplant may be able to replace     blood-forming cells that were destroyed by chemotherapy. Sometimes the transplanted cells     from a donor can make an immune response against the body's normal cells. Cyclosporine and     methotrexate may stop this from happening.      PURPOSE: This phase III trial is studying how well combination chemotherapy followed by a     donor stem cell transplant works in treating patients with hemophagocytic     lymphohistiocytosis.   "
190173|NCT00334685|"     The purpose of this study is to determine the effectiveness of adjunctive treatment of     pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN   "
190174|NCT00334698|"     The aim of this study is to assess the efficacy on nasal congestion and other allergic     symptoms and the onset of action of an oral combination of cetirizine and pseudoephedrine in     comparison to the single substances under controlled pollen exposure in an Environmental     Challenge Chamber (ECC).   "
190175|NCT00334711|"     The purpose of this study is to investigate whether patients with diabetes due to Kir6.2     mutations can be treated with sulfonylurea medication rather than insulin, and if this is the     case to investigate the mechanism for sulfonylurea response.   "
190176|NCT00334724|"     The purpose of this study is to determine whether blood pressure control by home blood     pressure monitoring exerts beneficial cardioprotective effects rather than by clinic blood     pressure monitoring in elderly patients.   "
194869|NCT00398788|"     The purpose of the study was to characterize the safety, effectiveness, and impact on quality     of life (QOL) measures of OROSÂ® hydromorphone HCL in patients with chronic low back pain.   "
190177|NCT00334737|"     Infants born prematurely do not increase production of the primary red cell growth factor,     erythropoietin (Epo), and often develop an anemia called the anemia of prematurity. The     anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of     Epo production. Human recombinant Epo (rHuEpo), given three to five times a week, is     successful in treating the anemia of prematurity. A slightly modified, long-acting version of     rHuEpo, called darbepoetin alfa (darbepoetin), is now available and has proven effective in     increasing hematocrit (red blood cell levels) in adults. In addition to its red cell     stimulating properties, recent evidence has shown that rHuEpo is protective in the developing     or injured brain. We have designed a randomized, masked, placebo-controlled study to     determine the safety and short and long term efficacy of darbepoetin. At this time,     darbepoetin has been studied primarily in adults and pediatric patients, but there is     evidence from pilot studies that darbepoetin would be useful in the neonatal setting as well.     It also may well improve neurodevelopmental outcomes in preterm neonates. We hypothesize     that: 1. The administration of darbepoetin to preterm infants 500 to 1,250 grams birth weight     will result in increased reticulocyte counts and decreased transfusions compared to placebo;     and 2. The administration of darbepoetin will be associated with an increased mental     developmental index at 18-22 months compared to placebo.   "
190178|NCT00334750|"     This descriptive, non-interventional study will collect information on the presence of risk     factors in newly diagnosed ocular hypertension and open-angle glaucoma patients in Canada.   "
190179|NCT00334763|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells     by blocking blood flow to the tumor. Giving radiation therapy together with chemotherapy and     monoclonal antibody therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving radiation therapy together with     chemotherapy and bevacizumab works in treating patients with recurrent, unresectable or stage     III or stage IV non-small cell lung cancer.   "
190180|NCT00334776|"     RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help     the body build an effective immune response to kill melanoma cells.      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients     with metastatic melanoma.   "
190181|NCT00334789|"     This phase I trial is studying the side effects and best dose of belinostat when given     together with isotretinoin in treating patients with metastatic or unresectable solid tumors.     Belinostat may stop the growth of tumor cells by blocking blood flow to the tumor and by     blocking some of the enzymes needed for cell growth. Isotretinoin may cause solid tumor cells     to look more like normal cells, and to grow and spread more slowly. Giving belinostat     together with isotretinoin may be an effective treatment for metastatic or unresectable solid     tumors.   "
190182|NCT00334802|"     To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients     with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline     regimen   "
190183|NCT00334815|"     This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in     treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be     removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor     cells by blocking blood flow to the tumor. Giving more than one drug (combination     chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.   "
190184|NCT00334828|"     The purpose of this study is to compare eritoran tetrasodium and placebo in patients with     severe sepsis and to demonstrate a reduction of mortality from all causes.   "
190694|NCT00344552|"     The purpose of this clinical research study is to learn if BMS-181339 can shrink or slow the     growth of the cancer in patients with advanced or recurrent esophageal cancer. The safety of     this treatment will also be studied.   "
190185|NCT00334841|"     Leptin, a circulating hormone expressed abundantly in adipose tissue, has been reported to be     a satiety factor. In addition, it has been shown to increase during pregnancy in maternal     blood, parallel to increase in body fat mass, to correlate with fetal body weight gain and to     fall down to basal levels after delivery.      Little is known about leptin levels in pregnant women with preexisting or gestational     diabetes and their relationship with fetal and postnatal growth and perinatal complications.      Therefore, the proposed study aims to understand and characterize the role of leptin in     gestational diabetes mellitus as well as the relationship between leptin, cytokines and the     pathophysiological complications during diabetic pregnancy. Specifically, we will evaluate 60     pregnant women both in Germany and in Israel and evaluate serum levels and mRNA of leptin,     cytokines (inflammatory as well as Th1 and Th2) and correlate them to maternal changes of     body weight and birth weight in women of various degrees of glucose tolerance and with     various degrees of metabolic control during pregnancy; relationship between serum and     umbilical cord vein concentrations of leptin, cytokines and metabolic variables; placental     expression of leptin, leptin receptor, selected cytokines, GLUT1 and 4 and relationship to     leptin in serum and umbilical cord plasma; comparison between all above parameters of German     and Israeli pregnant women.      The results of this new and systematic study will shed light on the role of leptin and     cytokines in the development of glucose disturbances during pregnancy and the perinatal     outcome of women with gestational or preexisting diabetes mellitus.   "
190200|NCT00335036|"     This is a randomized, prospective clinical trial comparing 2 different types of implantable     cardioverter defibrillator (ICD) leads in children and patients with congenital heart     disease. ICD lead survival in this patient group is particularly suboptimal, and lead     extraction is technically difficult and carries a substantial morbidity risk. Recently,     improved ICD lead designs have been released and are currently being utilized in patients.     The main aim of the study is to determine if either type of lead performs better in terms of     implantation electrical characteristics, long-term survival without breaking, and ease of     extractability.   "
190187|NCT00334867|"     RATIONALE: Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide,     ifosfamide, etoposide, and topotecan, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery     may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.     Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is     not yet known which combination chemotherapy regimen is more effective in treating Ewing's     sarcoma.      PURPOSE: This randomized phase III trial is studying combination chemotherapy and topotecan     to see how well they work compared with combination chemotherapy alone in treating patients     with newly diagnosed localized Ewing's sarcoma.   "
190188|NCT00334880|"     The purpose of this study is to evaluate the safety and effectiveness of NRP104 administered     as a daily morning dose (30, 50, and 70mg/day) compared to placebo in adults (18-55 years of     age inclusive) diagnosed with moderate to severe Attention Deficit Hyperactivity Disorder     (ADHD).   "
190189|NCT00334893|"     This phase II trial is studying how well eribulin mesylate works in treating patients with     recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Drugs used     in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing.   "
190190|NCT00334906|"     The purpose of this study is to characterize the progression of disease using volumetric MRI     techniques and cognitive outcome measures in patients with moderate dementia of the     Alzheimer's type treated with open-label memantine.   "
190191|NCT00334919|"     The purpose of this study is to determine if the naturopathic Anti-Inflammatory Diet results     in reduced inflammation and a better response by the immune system when compared to a     standard diabetic diet based on the current American Diabetes Association guidelines.   "
190192|NCT00334932|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and     melphalan, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Giving doxorubicin hydrochloride     liposome and melphalan together with bortezomib may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of doxorubicin     hydrochloride liposome , melphalan, and bortezomib and to see how well they work in treating     patients with relapsed or refractory stage I, stage II, or stage III multiple myeloma.   "
190193|NCT00334945|"     The purpose of this study is to evaluate the effect of growth hormone treatment on phosphorus     levels in the body. Phosphorus is an important mineral for bone growth. It is well known that     growth hormone treatment improves bone density and bone mineral content. The amount of     phosphorus is maintained by the kidneys. Fibroblast Growth Factor 23 has recently been     recognized to help kidneys control phosphate levels.   "
190194|NCT00334958|"     The primary objective of this study is to evaluate the effect of rufinamide on total partial     seizure frequency in adolescent and adult patients with refractory partial onset seizures     currently inadequately treated with a maximum of three stable antiepileptic medications.     Secondary objectives are to evaluate the effect of rufinamide on secondary and exploratory     outcomes, to confirm the safety profile of rufinamide, and to assess the relationship between     rufinamide plasma concentration and efficacy.   "
190195|NCT00334971|"     The purpose of the study is to understand how the ovarian follicle (the fluid filled     structure in the ovary that contains the egg) makes estrogen and other hormones during normal     aging, in women with different ethnic backgrounds, and in Fragile X premutation carriers.      During reproductive aging, estradiol levels are increased, a phenomenon that may be related     to increased aromatase activity. The investigators' own preliminary data suggest that     estradiol is increased in African-American women compared to Caucasian women, which may also     be related to aromatase activity. In addition, the investigators have examined female fragile     X premutation carriers who still have regular menstrual cycles and have demonstrated evidence     of early ovarian aging compared to age-matched controls.      **WE ARE RECRUITING ONLY WOMEN WITH FRAGILE-X PREMUTATION**   "
190197|NCT00334997|"     RATIONALE: Endoscopic surgery is a less invasive type of surgery for laryngeal cancer and may     have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to     kill tumor cells. It is not yet known whether endoscopic surgery is more effective than     radiation therapy in treating laryngeal cancer of the glottis.      PURPOSE: This randomized phase II trial is studying endoscopic surgery to see how well it     works compared with radiation therapy in treating patients with stage 0, stage I, or stage II     laryngeal cancer of the glottis.   "
190198|NCT00335010|"     The aim of the present study was to investigate if NTG, administered intravenously during     gastric tube reconstruction, could preserve gastric fundus tissue blood flow and oxygenation     and reduce the incidence of postoperative leakage.   "
190199|NCT00335023|"     Postpartum haemorrhage (PPH) is one of the top five causes of maternal mortality in developed     and developing countries. The most important treatment of PPH is red blood cell (RBC)     transfusion. The decision whether to prescribe RBC transfusion is mostly based on postpartum     haemoglobin (Hb) values. RBC transfusion should be aimed to reduce morbidity and especially     to improve Health Related Quality of Life (HRQoL). The goal of the WOMB study is to assess     the effect of RBC transfusion on HRQoL and to confirm the role of HRQoL in deciding whether     RBC transfusion is necessary.   "
190238|NCT00335569|"     The purpose of the study is to evaluate the clinical equivalence and the general tolerability     of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle, Serono) when     administered to patients undergoing IVF.   "
190282|NCT00336180|"     The purpose of this trial is to test the effectiveness of a classroom-based prevention     program (HealthWise: Learning Life Skills for Young Adults) to reduce the risk of HIV/AIDS     and STIs, as well as substance use, among adolescents in one area of South Africa.   "
190201|NCT00335049|"     At this time, we do not know what causes a child to become more nearsighted (myopic). STAMP     will help us better understand nearsightedness in children. Children will be randomly chosen     to wear regular glasses (single vision lenses) or no-line bifocal glasses (progressive     addition lenses) for the first year of the study. All children will wear regular glasses for     the second year of the study. STAMP will compare how the eye changes shape in the two groups     to help us understand why children become nearsighted. The two theories of myopia progression     that are being evaluated are based on different factors. One theory is based on environmental     factors such as extended near work while the other theory is based on genetically coded     factors.   "
190202|NCT00335062|"     Graves' disease, the most common form of hyperthyroidism in children, is caused by     Thyrotropin (TSH) Receptor Antibodies (TRAbs) that mimic the action of TSH. The disease leads     to significant morbidity in children both due to the prolonged course of antithyroid     medication often required for sustained immunological remission and the high risk of relapse     when medication is withdrawn. The ability to predict which patients are most likely to fail     medical management would greatly improve the choice of therapy. In the past, large goiter     size, age at diagnosis, increased biochemical severity, and decreased body mass index have     all been associated with a poorer prognosis, but these clinical indicators lack sensitivity     and specificity. Preliminary data suggest that the new TRAb assays are both sensitive and     specific for the measurement of TRAbs in children with Graves' disease. In addition,     variation in these antibodies over time is not the same in all patients. The goal of this     proposal will be to prospectively follow children with newly diagnosed Graves' disease and     use microarray technology to determine if there are genes whose expression differ in patients     who respond to medical therapy versus those who will need more definitive therapy earlier in     their disease.   "
190203|NCT00335075|"     The primary purpose of the study is to evaluate the efficacy and safety of temozolomide     compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic     astrocytoma.   "
190204|NCT00335088|"     The hypothesis is that povidone iodine alone is sufficient for sterilization of the lacrimal     sac and eye lids before intraocular surgeries. Patients admitted for various intraocular     surgeries will be randomly allocated to prophylactic local therapy with either moxifloxacin     and povidone iodine or povidone iodine alone before surgery. Lacrimal sac and eye lid     cultures will be obtained before the local therapy and just before surgery.   "
190205|NCT00335101|"     The study is to evaluate and compare the effects on kidney function of three iodinated     contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr)     concentrations up to three days after CM administration.   "
190206|NCT00335114|"     Cyclosporine Ophthalmic Emulsion is currently used in the treatment of dry eye syndrome.     Contact lens wearers frequently suffer from dry eye syndrome. The purpose of this study is to     evaluate cyclosporine ophthalmic emulsion verses re-wetting drops in the relief of dry eye     symptoms in contact lens wearers   "
190207|NCT00335140|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,     such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving rituximab together with combination chemotherapy may kill     more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with combination     chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.   "
190208|NCT00335153|"     The primary objective of this study will be to provide further evidence of the long-term     safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in     participants with advanced Parkinson's disease (PD) and severe motor fluctuations.   "
190209|NCT00335166|"     This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment     with SLV308 as monotherapy in patients with early stage PD. An open label safety extension to     this study is planned as a separate protocol for patients who are willing and eligible to     participate.   "
190210|NCT00335179|"     Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes     that are turned on, and turned off, by skin cells. Some of the drug induced changes in skin     cells should also be visible using a special microscope. This study examines both types of     changes.   "
190211|NCT00335192|"     The purpose of this study is to evaluate if there are pharmacokinetic interactions between     the NRTI 3TC and ABV, and the TDF nucleotide. For this purpose, the intracellular and plasma     levels of 3TC and ABV will be compared in patients given these nucleosides with TDF and 30     days after the interruption of the TDF.   "
190212|NCT00335205|"     We hypothesize that depressed patients who have not responded to their current antidepressant     medication will respond to the addition of ropinirole to their current regimen at a rate     better than placebo.   "
190213|NCT00335218|"     The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on     abdominal fat distribution measured by magnetic resonance imaging.   "
190239|NCT00335582|"     In Canada 1 patient in 200 dies within 30 days of an operation. More than half of these     deaths are the direct result of a heart related complication. This cause of death happens 4     times more often than in the same people who do not have an operation. We do not have an     effective way to stop these heart attacks. Stress causes the heart rate and the blood     pressure to go up which causes the heart to work harder and may be the reason for some heart     attacks. One group of drugs that stops the heart from working harder and decrease the number     of heart related complications are BETA-BLOCKERS. We wish to add another drug, which has been     shown to reduce heart rate and blood pressure, will reduce the number of heart attacks after     an operation. CLONIDINE has been shown to reduce heart attacks after operations. Since we     know it is not a good idea to stop beta-blockers we want to see if giving clonidine as well     as a beta-blocker is safe and has the desired effect of decreasing the number of heart     attacks. We want to find out how good the combination of these two drugs are at decreasing     the number of heart attacks.      Hypothesis: The addition of clonidine to chronic b-blockade will reduce mortality and cardiac     morbidity among intermediate-to-high risk patients undergoing non-cardiac surgery.   "
190214|NCT00335231|"     Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an     infection of the anterior chamber of the eye caused by bacterial contamination and     colonization through surgical incisions. Bacteria are thought to originate mainly from the     patient’s skin and studies show that bacteria are commonly found in the anterior chamber     following surgery. However, innate immune defences are usually able to control and eliminate     bacterial growth before postoperative endophthalmitis occurs. Also, due to the low incidence     of postoperative endophthalmitis, it is difficult to accurately evaluate preventative     methods. This study will examine the efficacy of topical preoperative administration of     gatifloxacin (a new fourth generation fluoroquinolone antibiotic) on reduction of bacterial     contamination of the anterior chamber following cataract surgery. If the antibiotic is shown     to lower bacteria count in cultures from anterior chamber fluid, it has the potential to     lower the incidence of postoperative endophthalmitis.      Patients undergoing cataract surgery will be notified and asked to participate in the study     by the physician in advance of the surgery, provided they do not possess any exclusion     criteria. The participants will be randomly split into two groups; one group will receive     topical application of gatifloxacin prior to surgery, while the other group will receive no     eye drops. During surgery, a small sample of anterior chamber fluid will be removed from the     eye and cultured in both broth and enrichment media for all subjects. Bacterial growth, i.e.,     colony forming units (CFUs), will be used as an indicator of the bacterial contamination of     the fluid.   "
190215|NCT00335244|"     This clinical trial will determine the safety and effectiveness of intravenous L-citrulline     in children undergoing cardiopulmonary bypass during heart surgery. Participants will be     randomly assigned to either L-citrulline or a placebo (a substance that has no medicine in     it).      Citrulline is a protein building block in the body that can convert into another substance,     nitric oxide (NO), which controls blood pressure in the lungs. Increased blood pressure in     the lungs can be an important surgical problem; it may also lead to problems following     surgery, such as severe high blood pressure in the lungs (pulmonary hypertension), increased     time spent on a breathing machine, and a longer stay in the intensive care unit (ICU). The     hypothesis of this study is that perioperative supplementation with intravenous citrulline     will increase plasma citrulline, arginine and NO metabolites and prevent elevations in the     postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical     ventilation.   "
190216|NCT00335257|"     The study compares the short- and long-term risks of a 24-day regimen of a     drospirenone-containing oral contraceptive with the risks of established oral contraceptives     in a study population that is representative for the actual users of the individual     preparations.   "
190217|NCT00335270|"     The purpose of this study is to evaluate the antiretroviral efficacy, safety, and     tolerability of fos-amprenavir boosted with either of two doses of ritonavir (RTV) when     administered in combination with ABC/3TC (abacavir/lamivudine, Epzicom®) FDC (fixed dose     combination) in a once-daily regimen over 96 weeks in ART-naïve, HIV-infected adults   "
190218|NCT00335283|"     The purpose of this study is to determine whether aggressive acid suppression with     Lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors     of response based on clinical and physiologic parameters.   "
190219|NCT00335296|"     The primary objective of this study is to demonstrate the safety and performance of the PFx     Closure System when utilized for patients with PFOs suffering from cryptogenic stroke,     transient ischemic attack, migraine or decompression illness.   "
190220|NCT00335309|"     The purpose of this study is to evaluate the effectiveness of maxillary sinus saline     irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy     alone in the management of chronic rhinosinusitis, a prospective randomized controlled trial.   "
190221|NCT00335322|"     In treatment naïve HIV infected subjects, combination antiretroviral therapy including     efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral     efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with     tenofovir and emtricitabine or tenofovir and emtricitabine combined with zidovudine and     abacavir, as assessed by change from baseline plasma HIV-1 RNA viral load.   "
190289|NCT00336271|"     In this study, participants will be eligible to participate in a paid research study that     will examine the effects of regular coffee drinking. The study takes approximately 2 hours     total, 55 min. on 2 separate days. Participants will be asked to do computer tasks and drink     only coffee provided to them during the study.   "
190222|NCT00335335|"     CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses     x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins     throughout the body.      VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart     arteries. The pictures it produces of the heart and its blood vessels will be reviewed and     compared to those obtained during the catheter-based coronary angiography to see if the CTA     shows the same blockages.   "
190223|NCT00335348|"     This study has two main aims. The first is to assess whether Dexamethasone can increase the     number of patients with who respond to Velcade.      The second aim of this study is to see whether treating patients with relapsed multiple     myeloma with Velcade and Dexamethasone for a longer period of time extends the time that the     myeloma is under control.   "
190224|NCT00335361|"     The study is to evaluate a device for male reproductive sterilization and determine if this     device is successful at blocking the sperm.      Ninety subjects from two centers in the United Stated will be followed closely for 24 months.      If you are someone interested in a vasectomy, you may be eligible to participate in this     clinical study.   "
190225|NCT00335374|"     This is a multicenter, 6 months open label safety extension study for all patients who are     willing and eligible to continue from the pivotal, double-blind S308.3.003 trial   "
190240|NCT00335595|"     The purpose of this study is to compare the free time to disease progression of combination     therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus     capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease     progression or a premature drop out of the study.   "
190295|NCT00336349|"     Effective treatment of neuropathic foot pain in diabetic patients is very important to     improve their quality of life. There are many medications used to reduce the diabetic     neuropathic pain, including anticonvulsants, anti-depressants or analgesics, but none is     universally satisfied. A few previous studies employing BOTOX® i.d. injection for control of     trigeminal neuralgia, post-herpes neuralgia indicate that BOTOX® was effective in controlling     neuropathic pain. Intradermal injection of BOTOX® to the dorsum of the foot in diabetics     should be effective in controlling diabetes-associated polyneuropathic pain of the foot.   "
190226|NCT00335400|"     To prepare the eye for cataract surgery, drugs must be given to the eye to allow for surgery     to take place. Traditionally, dilating drops and drops containing NSAIDs (to control     inflammation) are given to the patient well in advance of surgery at repeated time intervals.     As well, a gel containing lidocaine is applied to the eye just prior to surgery to     anesthetize (reduce pain and feeling) in the area of the eye. Although effective, the     procedure is time-consuming and costly for nursing staff. Recently, a few hospitals have     reported success in mixing the pupil-dilating and NSAID drops with the lidocaine gel,     creating an anesthetic dilating gel. Although success has been reported, there have been no     studies to clearly demonstrate that the anesthetic dilating gel is as effective at dilating     the pupil and reducing sensitivity of the cornea during surgery than the traditional methods     of drops and gel. It is possible that the dilating gel is less effective due to slower     diffusion of drugs into the eye. The study will compare the effectiveness of the anesthetic     dilating gel with the standard pre-operative pharmacologic regimen for cataract surgery.     Stability (maintaining effectiveness over time) and contamination of the study gel will also     be assessed. If the dilating gel is shown to be as effective in regards to pupil dilation and     corneal anesthesia, while maintaining stability and sterility over time, hospitals can be     encouraged to use such a anesthetic dilating gel routinely during pre-operative procedures     before cataract surgery.   "
190227|NCT00335413|"     To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive     type 1 diabetic patients.   "
190228|NCT00335426|"     The purpose of this study is to determine if spinal manipulative therapy can affect cognitive     processing as determined by performance on a Stroop task. It is specifically hypothesized     that number of errors and response times will decrease as a result of spinal manipulative     therapy.   "
190229|NCT00335439|"     The study will evaluate the efficacy of prophylactic administration of the topical     nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid     macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent     cause of decreased vision after uncomplicated cataract surgery and can result in irreversible     sight reduction. The investigation will involve a comparison arm and a treatment arm with     both sets of patient populations being evaluated for CME with ophthalmologic examinations and     optical coherence tomography (OCT) measurements. The objective is to elucidate the role of     NSAID drops in preventing CME after cataract surgery.   "
190230|NCT00335452|"     The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin     (two doses) will decrease the risk of ischemic complications (cardiac death (CV death),     myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).   "
190231|NCT00335465|"     The primary objective of the present study is to assess changes of myocardial glucose uptake     (MGU) during clamp studies using positron emission tomography (PET) scanning in patients with     type 2 diabetes and idiopathic left ventricular dysfunction (LVD).      The secondary objectives of the study are: assessment of changes of myocardial     microcirculation at rest and during adenosine stimulation using PET; assessment of changes in     myocardial structure and function evaluated by magnetic resonance imaging (MRI); assessment     of glycaemic control by measurement of HbA1c, fasting blood glucose and insulin levels;     assessment of safety (adverse event profile, laboratory data).   "
190232|NCT00335478|"     RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in     patients with cancer.      PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia     and fever in patients with cancer.   "
190233|NCT00335491|"     RATIONALE: Exercise may help improve mobility and relieve fatigue and/or weakness in cancer     survivors. It is not yet known whether exercise is more effective than standard therapy in     improving mobility and reducing fatigue and/or weakness in older cancer survivors.      PURPOSE: This randomized clinical trial is studying exercise to see how well it works     compared to standard therapy in improving mobility and reducing fatigue and/or weakness in     older cancer survivors.   "
190234|NCT00335504|"     This randomized phase II trial is studying atorvastatin calcium to see how well it works     compared to oligofructose-enriched inulin, sulindac, or a placebo in preventing cancer in     patients at increased risk of developing colorectal neoplasia. Chemoprevention is the use of     certain drugs or substances to keep cancer from forming, growing, or coming back. The use of     atorvastatin calcium, oligofructose-enriched inulin, or sulindac may stop cancer from forming     in patients at increased risk of colorectal neoplasia. It is not yet known whether     atorvastatin calcium, oligofructose-enriched inulin, or sulindac are more effective than a     placebo in preventing cancer in patients at increased risk of developing colorectal     neoplasia.   "
190235|NCT00335517|"     The purpose of the study is to help determine the appropriate dose of DepoDur for use in     spinal surgery. The study will also assess the safety of this drug in this patient     population.   "
190236|NCT00335543|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy     together with radiation therapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill     any tumor cells that remain after surgery. It is not yet know whether giving chemotherapy     together with radiation therapy before surgery is more effective than surgery alone in     treating pancreatic cancer.      PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and cisplatin     together with radiation therapy before surgery works compared to surgery alone in treating     patients with localized pancreatic cancer that can be removed by surgery.   "
190237|NCT00335556|"     This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or     surgery work in treating patients with high-risk kidney tumors. Drugs used in chemotherapy     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     combination chemotherapy together with radiation therapy before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed.   "
194870|NCT00398801|"     The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology,     natural history, clinical course, and other outcomes of gastroparesis.   "
190241|NCT00335621|"     Some patients with chronic obstructive pulmonary disease (COPD) take nebulised treatments to     ease the symptom of breathlessness, including the drug ipratropium. Nebulised bronchodilator     drugs are taken up to 4 times through the day, and this can take up to 15 minutes each time.     Although the treatment isbe effective, patients report that the time taken to set-up and use     the nebuliser can be a disincentive to regular use. By contrast, an inhaler device is easy to     use following appropriate instruction, and takes only a few seconds to administer. Inhaled     tiotropium is a once daily treatment taken by inhaler which has been shown to be effective in     COPD. We wish to assess whether inhaled Tiotropium as effective as nebulised ipratropium in     patients with stable chronic obstructive pulmonary disease.   "
190242|NCT00335634|"     The purpose of this study is to explore patient and partner experiences with sexual     dysfunction following radical prostatectomy, in order to understand its effects on sexual and     non-sexual intimacy. This will enable us to provide assistance in the future to individuals     experiencing similar circumstances.   "
190243|NCT00335647|"     RATIONALE: Drugs used in chemotherapy, such as fluphenazine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I/II trial is studying the side effects and best dose of fluphenazine and     to see how well it works in treating patients with refractory advanced multiple myeloma.   "
190244|NCT00335660|"     The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1)     antagonist, in subjects with Idiopathic Detrusor Overactivity.   "
190245|NCT00335673|"     -  To evaluate control rate of Blood Pressure ≤ 140/90 mm Hg in non-diabetic patients, and          ≤ 130/80 mm Hg in diabetic patients.        -  To determine percentage of patients achieving blood pressure control according to their          profile (naïve, switch, patient history, etc…) at the end of the trial.   "
190246|NCT00335686|"     The study aims to evaluate the changes in mitochondrial DNA (mDNA) by means of the     mDNA/nuclearDNA (nDNA) ratio as a marker of mitochondrial toxicity following the interruption     of nucleoside analogues.   "
190247|NCT00335699|"     The primary objective of this study is to compare the effect of rosuvastatin 10mg with     atorvastatin 10mg in the percentage reduction of LDL-C in Subjects with metabolic syndrome     after 6 weeks of treatment.   "
190248|NCT00335712|"     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of     ONO-5129 in patients with type 2 diabetes mellitus.   "
190249|NCT00335725|"     Purpose of the study is the comparative evaluation of the clinical efficacy and of the     general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs     Gonal-F® Serono) when administered in patients undergoing ICSI   "
190250|NCT00335738|"     This phase III trial is studying vincristine, carboplatin, and etoposide to see how well they     work compared to observation only in treating patients who have undergone surgery for newly     diagnosed retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and     etoposide, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery,     no additional treatment is needed for the tumor until it progresses. In this case,     observation may be sufficient.   "
190251|NCT00335751|"     RATIONALE: Diagnostic procedures, such as PET scan and CT scan, may help doctors determine     the extent of cancer and predict a patient's response to treatment and help plan the best     treatment.      PURPOSE: This clinical trial is studying how well PET scan combined with CT scan evaluates     treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma.   "
190322|NCT00323843|"     Is it possible to decrease the intrarenal pressure in the kidney during endoscopic management     of kidney stone by topical administration of drugs? In order to secure fewer complications in     ureteroscopic operations the pharmacological agent isoproterenol is tested on pigs and human     to determine its potential of lowering intrarenal pressure.   "
190252|NCT00335764|"     This phase I/II trial is studying the side effects and best dose of erlotinib, tipifarnib,     and temsirolimus when given together with sorafenib and to see how well they work in treating     patients with recurrent glioblastoma multiforme or gliosarcoma. Sorafenib, erlotinib,     tipifarnib, and temsirolimus may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor     cells by blocking blood flow to the tumor. Giving sorafenib together with erlotinib,     tipifarnib, or temsirolimus may kill more tumor cells.   "
190253|NCT00335777|"     This is a research study looking at Migranal (study drug) in the treatment of two migraine     attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us     al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a     headache. It has been noted in several studies that in patients with migraine, seventy nine     percent of the patients experienced allodynia on the facial skin on the same side as the     headache. Understanding more about allodynia may help us understand how the pain system works     in migraine.      This study will compare the differences, if any, in attacks treated early with study drug (at     1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat one     attack early and one attack late for this study. If the first attack you treat is early (at 1     hour following onset of throbbing pain) then the second attack you treat should be late (at 4     hours following onset of throbbing pain).      It is hoped that this study will provide information on the use of Migranal in subjects who     have cutaneous allodynia. The results from this study may be used in the development of     larger clinical trials. The study drug is a medication that is taken in the form of nasal     spray.   "
190266|NCT00335959|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy     together with radiation therapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine     together with radiation therapy works in treating patients with stomach cancer that can be     removed by surgery.   "
190267|NCT00335972|"     We propose to test whether intraoperative administration of dexmedetomidine will reduce     hemodynamic control in the intra- and post-operative periods and reduces PACU analgesic     requirements in patients undergoing carotid endarterectomy.   "
190310|NCT00336557|"     An observational study to determine the impact of multiple neutralizing antibody (NAb) tests     on treatment patterns compared to the usual care of MS patients receiving high-dose IFN     therapy.   "
190254|NCT00335790|"     Autism is a neurodevelopmental disorder currently affecting as many as 1 out of 166 children     in the United States. Autism is considered by many to be a permanent condition with little     hope for improvement. Treatment for autism is centered on special schooling and behavioral     therapy; medical science currently has little to offer. Recent research has discovered that     some autistic individuals have decreased blood flow to the brain, evidence of     gastrointestinal and brain inflammation, increased markers of oxidative stress, and a     relative mitochondrial dysfunction. Hyperbaric oxygen therapy (HBOT) can compensate for     decreased blood flow by increasing the oxygen content of plasma and body tissues and can even     normalize oxygen levels in ischemic tissue. In addition, animal studies have shown that HBOT     has potent anti-inflammatory effects and reduces oxidative stress. Furthermore, recent     evidence demonstrates that HBOT increases the production of mitochondria and mobilizes stem     cells from human bone marrow, which may aid recovery in neurodegenerative diseases. Based     upon these findings, it is hypothesized that HBOT will improve symptoms in autistic     individuals.      Our recent retrospective case series demonstrated that HBOT may improve symptoms in autistic     children. We recently completed a prospective pilot trial using HBOT in 18 children which     demonstrated significant clinical improvements in autistic children on several standardized     scales. Most of the scales were parent-rated, although some were rated by teachers. However,     parents were not blinded to the fact that their children received HBOT and evaluation of the     children was through parent-rated scales, either of which could lead to bias. There was no     placebo or control group. Therefore, the improvements found in this prospective study could     have been due merely to chance or the natural development of the children. To determine if     HBOT improves symptoms in autistic children, a double-blind controlled study is needed.   "
190255|NCT00335803|"     Chronic daily headache has been classified into several categories. One category is of sudden     onset and is called New Daily Persistent Headache (NDPH). Another category of daily headache     evolves gradually and is called Transformed Migraine (TM). This research study is being     conducted to compare people with these two kinds of daily headache in order to improve our     understanding of these conditions.   "
190256|NCT00335816|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Fluorouracil may also make tumor cells more sensitive to radiation therapy.     Leucovorin calcium may protect normal cells from the side effects of chemotherapy, and it may     help fluorouracil work better by making tumor cells more sensitive to the drug. Giving     radiation therapy together with chemotherapy before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving radiation therapy together with     fluorouracil with or without combination therapy works in treating patients who are     undergoing surgery for stage II or stage III rectal cancer.   "
190257|NCT00335829|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Chemoembolization kills tumor cells by carrying chemotherapy drugs     directly into the tumor and blocking the blood flow to the tumor. Giving bevacizumab together     with chemoembolization may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with     chemoembolization works in treating patients with liver cancer that cannot be removed by     surgery.   "
190290|NCT00336284|"     This study is a multi-center, prospective and randomized trial. The primary objective of this     study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely     reduce the number of regularly scheduled office follow-up visits, compared to the     conventional method of implantable cardioverter defibrillator (ICD) follow-up.   "
190258|NCT00335855|"     The purpose of this study is to evaluate the safety, effectiveness, and tolerability, of the     Pharma-Pen(TM) intramuscular (IM) and subcutaneous (SC) auto-injector systems used by     untrained users to self-administer Influenza vaccines as compared to standard IM injections     administered by a licensed healthcare professional (e.g. a nurse). Participants will be 120     healthy men and women aged 18 - 50 years who have not received influenza vaccine for at least     four years and who have no experience in giving intramuscular or subcutaneous injections.     Subjects will be randomly placed in one of three treatment types. They will receive one     injection of commercially available Influenza vaccine and will be evaluated over the course     of six months.   "
190259|NCT00335868|"     RATIONALE: PHA-739358 may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well PHA-739358 works in treating patients with     chronic myelogenous leukemia that relapsed after imatinib mesylate or c-ABL therapy.   "
190260|NCT00335881|"     Persistence of seroprotective antibody concentrations & immunological memory shown by the     ability to mount a response to a challenge dose of HBV vaccine   "
190261|NCT00335894|"     Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two     parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and     the other the reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.).   "
190262|NCT00335907|"     This research is being done to see if a protocol (a set of orders that determine how much and     how quickly a drug/fluid is given) for fluid and drugs used to increase blood pressure     (vasopressors) will work better then general clinical practices to improve outcomes in     patients with septic shock.   "
190263|NCT00335920|"     The purpose of this study is to evaluate the efficacy and safety of an intratympanic     continuous two-week application of dexamethasone compared to placebo using a temporarily     implanted catheter in patients with severe to profound sudden sensorineural hearing loss and     insufficient recovery after initial systemic prednisolone therapy.   "
190264|NCT00335933|"     Gabapentin and pregabalin are treatments for some types of neuropathic pain, including     postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a     day for effective pain control. The purpose of this study is to determine whether a new     gabapentin tablet, which only needs to be taken once or twice a day, is safe and effective     for the treatment of postherpetic neuralgia.   "
190265|NCT00335946|"     The purpose of this study is to determine the effects of non-needle electro-acupuncture on     mild to moderate anxiety. The hypothesis is that this style of treatment will reduce state     anxiety and not trait anxiety as measured by the Spielberger STAI test.   "
190268|NCT00335985|"     This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy     of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based     on the changes in manual muscle strength (MMT) scores as primary endpoint, and in addition,     to assess the safety of GB-0998.   "
190311|NCT00336570|"     Principal Investigator: Arshed A. Quyyumi, MD      To establish normal values by age, race, and gender of novel markers of risk in healthy     subjects necessary to predict precise risk of cardiovascular disease in an individual.   "
190269|NCT00335998|"     Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. 3-AP     may also stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 3-AP and cisplatin may     make tumor cells more sensitive to radiation therapy. Giving 3-AP and external-beam radiation     therapy together with cisplatin may kill more tumor cells. This phase I trial is studying the     side effects and best dose of 3-AP when given together with external-beam radiation therapy     with or without cisplatin in treating patients with gynecologic cancer   "
190270|NCT00336011|"     To evaluate short-term and long-term effects by MR imaging on the technical and functional     status of Medtronic pacemakers.   "
190271|NCT00336024|"     This randomized phase III trial is studying two different combination chemotherapy regimens     to compare how well they work when given before a peripheral stem cell transplant in treating     young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or     high-risk medulloblastoma. Drugs used in chemotherapy work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     more than one drug (combination chemotherapy) together with a peripheral stem cell transplant     may allow more chemotherapy to be given so that more tumor cells are killed. It is not yet     known which combination chemotherapy regimen is more effective when given before a peripheral     stem cell transplant in treating supratentorial primitive neuroectodermal tumors or     medulloblastoma.   "
190272|NCT00336050|"     Asthma can be caused by many factors, including mold, pollen, and other airborne pollutants.     The purpose of this study is to evaluate the effect that air pollution has on the long-term     severity of asthma symptoms and lung function in children.   "
190273|NCT00336063|"     This phase I trial studies the side effects and best dose of vorinostat when given together     with azacitidine in treating patients with nasopharyngeal cancer or nasal natural killer     T-cell lymphoma that has recurred (come back) at or near the same place as the original     (primary) tumor, usually after a period of time during which the cancer could not be detected     or has spread to other parts of the body. Drugs used in chemotherapy, such as vorinostat and     azacitidine, work in different ways to stop the growth of cancer cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Vorinostat and     azacitidine also may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth. Giving vorinostat together with azacitidine may kill more cancer cells.   "
190318|NCT00323791|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor     cells.      PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see     how well they work compared with gemcitabine alone in treating patients with metastatic or     unresectable kidney cancer.   "
190274|NCT00336076|"     Mastocytosis is a disorder characterized by presence of excessive numbers of mast cells in     skin, bone marrow and internal organs. It can affect both children and adults, males and     females and individuals from all ethnic backgrounds, although precise demographic information     about the affected populations is not available as it is a rare disorder. Mastocytosis in     children is generally limited to the skin and follows a self limited course, while it is a     disorder of the hematopoietic stem cell associated with somatic mutations of the c-kit gene     in most patients with adult-onset of disease. There is no known curative therapy for most     patients with systemic mastocytosis. Recent research studies identified several subtypes of     disease with distinct clinical and pathologic features, however, a precise understanding of     the incidence as well as molecular pathology of different disease subtypes is lacking. This     study aims to examine molecular and cellular pathological aspects of disease in patients with     mastocytosis and correlate findings with clinical presentation and prognosis. Patients will     undergo a routine history and physical examination, and diagnostic tests will be ordered as     dictated by each patient's clinical presentation. Blood and bone marrow will be obtained for     diagnostic and research purposes. Genetic analysis of the c-kit gene regulating mast cell     growth and differentiation will be performed. It is hoped that findings obtained from this     study will help to design novel therapies for mastocytosis and other disorders in which mast     cells play a critical role.   "
190275|NCT00336089|"     RATIONALE: An exercise program or health education program may help relieve fatigue and pain     and improve the quality of life in women who are breast cancer survivors. It is not yet known     whether an exercise program is more effective than a health education program or no program     in reducing fatigue and pain in women who are breast cancer survivors.      PURPOSE: This randomized clinical trial is studying an exercise program to see how well it     works in reducing fatigue and pain compared to a health education program or no program in     women who are breast cancer survivors.   "
190276|NCT00336102|"     RATIONALE: Learning about thyroid dysfunction in patients with breast cancer may help plan     treatment and may help patients live more comfortably.      PURPOSE: This clinical trial is studying how often thyroid dysfunction happens in women with     newly diagnosed stage I, stage II, or stage III breast cancer who are planning to undergo     chemotherapy compared to how often it happens in healthy volunteers.   "
190277|NCT00336115|"     The purpose of this study is to determine if pertussis (whooping cough) vaccine is safe and     produces an appropriate immune response against pertussis in blood and marrow transplant     patients.   "
190278|NCT00336128|"     Behavioral intervention at Kindergarten setting aiming at increased fruit and vegetable     consumption, decreased intake of high energy foods, snacks, sweets, increased intake of     water/low energy drinks, decreased intake of high energy drinks. Physical activity should be     more than 1 hour/day and TV/media consumption less than 1 hour/day.      Main questions are:      Do children differ in intervention and control kindergartens according to their nutrition     behaviour? Do children in the intervention kindergartens have a higher physical training than     such in the control kindergartens? Data were collected with a standardised questionnaire.      Do children differ in intervention and control kindergartens according to their body mass     index?   "
190279|NCT00336141|"     This protocol will investigate the use of vorinostat (suberoylanilide hydroxamic acid - SAHA)     in combination with infusional 5-FU and leucovorin for the treatment of metastatic colorectal     cancer patients who have failed standard 5FU regimens.   "
190280|NCT00336154|"     Epidermolysis Bullosa(EB) is an inherited bullous disease. Tetracycline is believed to have     anti inflammatory properties. 20 patients with EB older than 13 years will be treated for 4     months with tetracycline or placebo. After one month of wash out they will be treated for     additional 4 m with placebo or tetracycline. The patients will be examined each month to     estimate bulla formation,rate of healing .   "
190283|NCT00336193|"     This proposal examines the impact of an augmented competency based approach to training of     home visitors and supervisors for delivery of the Nurse Family Partnership (NFP) on staff     performance, fidelity to the program model, and family outcomes relative to child     maltreatment and early behaviors associated with youth violence. The central premise     underlying the proposed study is that the augmented competency based curriculum and clinical     consultation to supervisors will improve nurses' knowledge and skills in working with     families, which in turn, will lead to greater fidelity to the home visit guidelines (i.e.,     quality implementation), which in turn, will result in better maternal and child health     outcomes.   "
190284|NCT00336206|"     The aim of the study is to evaluate if the treatment with Alemtuzumab (after I or II line     chemotherapy) administered for 6 weeks followed by 4 months maintenance treatment compared to     a control group can reduce disease activity/residual disease and thereby delay the     reoccurrence of the CLL disease.   "
190285|NCT00336219|"     The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux     disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An     endoscopy will be performed at study start and study end. During the study, the patients will     complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire).     The study duration consists of a baseline period (8 days) and treatment period (28 days).     Pantoprazole (tablet) will be administered once daily at one dose level. The study will     provide further data on safety and tolerability of pantoprazole.   "
190286|NCT00336232|"     The purpose of this study is to learn how the body responds to different amounts of vitamin K     in the diet in order to understand the roles that vitamin K may have in the body. We also     need to determine if older adults need more or less vitamin K in their diet compared to     younger adults in order to maintain normal body stores of vitamin K.   "
190287|NCT00336245|"     A randomized trial of the intrauterine contraceptive device (IUD) versus user's choice     hormonal contraception (injectable progestins or oral contraceptive pills) among     HIV-infected, recently post-partum women in Lusaka, Zambia.   "
190288|NCT00336258|"     The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT     detected by US-Doppler and procoagulant microparticles in a selected group of cancer patients     suffering from an advanced stage of the disease.      An attempt will be made to determine whether there is a correlation between this prevalence     and various clinical and laboratory parameters.   "
190291|NCT00336297|"     Recent reviews have identified the need for additional high quality exploratory and     evaluative research to understand 1) the actual impact on all women of instituting mass     screening procedures versus using indicator-based approaches to identifying woman abuse and     2) the extent to which early identification through screening -- either universal or     indicator-based is effective in preventing or ameliorating important outcomes. This is a     critical first step in developing a larger randomized controlled trial (RCT) which examines     the effectiveness of screening in preventing woman abuse, improving quality of life and other     associated outcomes. This study prepares for the RCT by testing the optimal method of     administration for the two screening instruments that will be used in the RCT. The     administration formats are: computer-based screen, paper and pencil screen and face-to-face     screen. They study will also determine recruitment rates.   "
190292|NCT00336310|"     The purpose of this study is to determine whether a new-brand of repaglinide is effective in     the treatment of type 2 diabetes patients.   "
190293|NCT00336323|"     This study will provide preliminary data on the dose and dose interval related effects of     intravitreally administered Avastin on retinal thickness and visual acuity in subjects with     Diabetic Macular Edema (DME) to aid in planning a phase 3 trial.      In addition, this study will provide preliminary data on the safety of intravitreally     administered Avastin in subjects with DME.   "
190294|NCT00336336|"     INTRODUCTION While pharmacological treatments specifically targeted to the cardio-circulatory     system have been largely investigated, scanty controlled data are available concerning the     role of dietary and metabolic approaches in the management/outcome of patients with heart     failure. A large scale, randomized, clinical trial is proposed to test the effects of (a) n-3     PUFA and (b) a lipid lowering agent on top of the best recommended treatments for heart     failure.      STUDY DESIGN      The GISSI-HF is a prospective, multicenter, randomized, double blind, placebo controlled     study, with randomized allocation of patients with a clinical diagnosis of heart failure to:      Randomization 1 (R1): n-3 PUFA 1 g daily vs corresponding placebo; Randomization 2 (R2):     rosuvastatin 10 mg daily vs corresponding placebo.      OBJECTIVES OF THE STUDY PRIMARY OBJECTIVES      To demonstrate that, in patients with heart failure treated at the best of recommended     therapies, long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than     the corresponding placebo in the reduction of:        -  All-cause mortality        -  All-cause mortality or hospitalizations for cardiovascular reason      OTHER END-POINT MEASURES OF EFFICACY      To assess that long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective     than corresponding placebo in the reduction of:        -  Cardiovascular mortality        -  Cardiovascular mortality or hospitalizations for any reason        -  Sudden cardiac death        -  Hospitalizations for any reason        -  Hospitalizations for cardiovascular reasons        -  Hospitalizations for congestive heart failure        -  Myocardial infarction        -  Stroke   "
190312|NCT00336583|"     Oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide,     methylprednisolone, cytarabine and cisplatin (ESHAP). Clinical efficacy and toxicity of this     ESHAOX salvage regimen will be evaluated in refractory or relapsed non-Hodgkin's lymphoma     patients.   "
195097|NCT00403156|"     The purpose of study is to determine if Lucentis combined with imatinib mesylate will help     treatment in patients with newly diagnosed choroidal neovascularization.   "
190296|NCT00336362|"     Beta thalassemia major is a serious genetic disease of the blood. Treatments are limited, and     although a bone marrow transplant from a compatible donor can be curative, only a limited     percentage of individuals with this disease have a matched donor available. A long-term goal     of study researchers is to develop a gene transfer process as a method of curing beta     thalassemia major. Gene transfer involves obtaining blood stem cells from an individual,     adding a normal globin gene to the stem cells, and putting the cells back into the     individual.      Before gene transfer methods can be attempted in individuals with beta thalassemia major, a     safe method of obtaining blood stem cells needs to be developed. The purpose of this study is     to investigate the safety and feasibility of collecting peripheral blood stem cells (PBSC)     from individuals with beta thalassemia major. Research participants will be given G-CSF     (filgrastim) for several days to increase the number of stem cells in the blood, a process     called mobilization. After mobilization, participants will undergo a procedure called     apheresis to remove the white blood cells. Researchers in the laboratory will purify the stem     cells from the mixture and test methods of putting a normal globin gene into the stem cells.     Half of the participants will receive hydroxyurea (HU) prior to G-CSF mobilization. HU is     used in splenectomized patients to attempt to reduce the risk of clotting during     mobilization. In non-splenectomized patients, HU is given in an attempt to decrease the size     of the spleen.   "
190297|NCT00336375|"     The purpose of this explorative clinical trial is to study parasite population dynamics,     diversity and clearance kinetics of Plasmodium falciparum as well as determination of the     molecular mechanisms associated with drug resistance during the early phase of     artemether-lumefantrine treatment when the drug intake is either accompanied with or without     intake of fatty food. The hypothesis is that intake of fatty food together with     artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of     early selection of genetic markers related to drug resistance. The study population is     children aged 1-10 years with uncomplicated malaria in Bagamoyo District, Tanzania. Enrolled     children will be randomly allocated to either intake of a fatty meal or not together with the     study drug. Artemether-lumefantrine will be given twice daily for 3 days in standard doses     according to bodyweight. Study participants will be admitted during the study period (3     days)to allow close supervision and detailed blood sampling.   "
190298|NCT00336388|"     The purpose of this study is to investigate the impact of rapid diagnostic tests (RDTs) in     the context of a newly implemented malaria case management guidelines using artemisinin-based     combination therapy on the malaria prescribing practices of health care workers in Kenya.   "
190319|NCT00323804|"     Patients with chronic hepatitis C who did not respond to previous antiviral treatment develop     liver fibrosis leading to cirrhosis. Maintenance low dose pegylated interferon therapy of     fibrosis is currently under investigation in large multicenter trials. The aim of our study     is to assess if peginterferon alpha2b plus ribavirin is more efficient than peginterferon     alpha2b alone. 454 patients will be randomized between the 2 arms and the efficacy will be     assessed, after 3 years of treatment, on Metavir liver fibrosis score improvement.   "
190299|NCT00336401|"     Non-cardiac surgery is associated with significant cardiac morbidity and mortality. Volatile     anesthetics have a cardioprotective effects which results in preservation of left ventricular     function and lower troponin I levels. Lower troponin release has been correlated with better     long term event free survival in both cardiac and non cardiac surgery. A recently completed     meta-analysis suggests that sevoflurane is a superior volatile agent. The evidence of a     cardioprotective effect in non-cardiac surgery is lacking. Base on the current literature, we     intend to evaluate the protective potential of sevoflurane versus propofol anesthesia in high     risk patients undergoing elective non-cardiac procedures.      Hypothesis: The use of Sevoflurane as a general anesthetic reduces postoperative troponin     release, the incidence of myocardial infarction and/or long term morbidity in patients at low     to moderate risk of postoperative cardiac complications, who are undergoing noncardiac     surgery.   "
190300|NCT00336414|"     This is a 5-year project, involving 185 partners from 46 countries (110 in 21 EU States and     75 in 25 extra-EU States), with a randomised clinical trials (RCT) in juvenile systemic lupus     erythematosus (JSLE): 5-year phase III single-blind, RCT in children with newly diagnosed,     WHO class III, IV JSLE proliferative nephritis: PDN and oral cyclophosphamide (CYC) versus     high dose intravenous (iv) CYC versus intermediate dose iv CYC, followed by maintenance with     azathioprine.The trial is aimed to find out the treatment regimen associated with the lowest     occurrence of flare and the lowest drug related toxicity.   "
190301|NCT00336427|"     We hypothesize that pregnant women are at baseline risk for carrying community-acquired MRSA,     but also have frequent contact with healthcare workers which may put them at risk for     hospital-acquired MRSA carriage. Our study aimed to identify the colonization rate of women     in active labor and whether transmission to infants may occur.   "
190302|NCT00336453|"     The purpose of this study was to evaluate dose-related safety, reactogenicity and     immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza     vaccine, administered to healthy children aged 6 to 59 months.   "
190303|NCT00336466|"     Context: Neurocognitive dysfunction complicates coronary artery bypass graft surgery.     Neurocognitive dysfunction is a measurable problem with thinking. Erythropoietin may be a     neuroprotectant.      Objective: To investigate the feasibility and safety of three doses of human recombinant     erythropoietin to reduce neurocognitive dysfunction in coronary artery bypass graft patients.   "
190304|NCT00336479|"     Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa     2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV)     ribonucleic acid (RNA) levels   "
190305|NCT00336492|"     The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade)     in children with moderately to severely active ulcerative colitis.   "
190306|NCT00336505|"     The purpose of this study is to compare the efficacy of cethromycin to clarithromycin for the     treatment of mild to moderate community-acquired pneumonia (CAP).   "
190307|NCT00336518|"     Primary objective is to measure sustained viral response given to continuation or     prolongation of combined Pegasys&Copegus treatment      Secondary objective is to measure histological response given to continuation or prolongation     of combined Pegasys&Copegus treatment measured by non-invasive methods   "
190308|NCT00336531|"     The purpose of this study is to investigate whether the prophylactic use of itraconazole is a     better option than empirical use of itraconazole in the management (prevention and treatment)     of fungal infection associated with high-dose chemotherapy and autologous hematopoietic stem     cell transplantation in children with high-risk solid tumor.   "
190309|NCT00336544|"     The purpose of this study is to compare the efficacy and safety of cethromycin to     clarithromycin for the treatment of mild to moderate community-acquired pneumonia (CAP).   "
190313|NCT00336596|"     The purpose of the present, randomized, controlled multicenter phase III trial is to     investigate the safety and efficacy of continuous 1-hour insonation of occluded middle     cerebral artery with 2 MHz TCCS in stroke patients treated with intravenous tissue     plasminogen activator (t-PA) within 3 hours after symptom onset.   "
190314|NCT00336609|"     Observational (non-drug) study to look at the risks and burden of mucositis (sores) involving     the mouth, throat and intestines in patients receiving chemotherapy and radiation therapy     treatment for various cancer types.   "
190315|NCT00323752|"     The purpose of this study is to establish whether rHuEpo is as effective as PAD in increasing     red cell mass prior to surgery. Other benefits of the PAD program and preoperative     administration of rHuEpo will also be compared.   "
190316|NCT00323765|"     This study will identify changes that occur in the part of the brain that controls hand     movements in patients with cervical (neck) dystonia. Patients with dystonia have muscle     spasms that cause abnormal postures while trying to perform a movement. In focal dystonia,     just one part of the body, such as the hand, neck or face, is involved. The study will     compare findings in healthy volunteers and patients with cervical dystonia to learn more     about the condition.      Healthy volunteers and patients with cervical dystonia 18 years of age and older may be     eligible to participate. Candidates are screened with a medical history and physical     examination. Participants undergo the following tests:      Somatosensory evoked potentials (Visits 1 and 2)      This test examines how sensory information travels from the nerves to the spinal cord and     brain. An electrode placed on an arm or leg delivers a small electrical stimulus and     additional electrodes placed on the scalp, neck and over the collarbone record how the     impulse from the stimulus travels over the nerve pathways.      Transcranial Magnetic Stimulation (Visits 2, 3 and 4)      This procedure maps brain function. A wire coil is held on the scalp. A brief electrical     current passes through the coil, creating a magnetic pulse that stimulates the brain. The     stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear     a click and feel a pulling sensation on the skin under the coil.      Nerve conduction studies (Visits 2, 3 and 4)      This test measures how fast nerves conduct electrical impulses and the strength of the     connection between the nerve and the muscle. Nerves are stimulated through small wire     electrodes attached to the skin and the response is recorded and analyzed.      Surface electromyography (Visits 2, 3 and 4)      Electrodes are placed on the front and back of the neck muscles to measure the electrical     activity of the muscles.   "
190317|NCT00323778|"     This study looks at the effect of an injectable medication called Hyalgan on the cartilage of     the knee in people who have osteoarthritis (wear and tear arthritis) of the knee. Hyalgan     is a medication which is injected into the knee, and is FDA approved to treat knee arthritis.     We will be using magnetic resonance imaging (MRI) and x-rays to look at knee cartilage to see     how it responds over the course of a year to the injections. A comparison to patients taking     oral pain medication will be made.   "
190320|NCT00323817|"     To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia   "
190321|NCT00323830|"     The objective of the trial is to compare disease-free survival between adjuvant     capecitabine/cisplatin alone vs capecitabine/cisplatin with radiotherapy (chemoradiation) in     curatively resected gastric cancer patients.   "
190323|NCT00323856|"     The purpose of this study is to determine the immunologic and overall safety associated with     long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less     than 0.01 IU/ml), who have been previously treated with plasma-derived Factor VIII products     other than Alphanate and who have no history of developing either antibody inhibitors to     Factor VIII or nonspecific inhibitors of coagulation.   "
190324|NCT00323869|"     A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as     treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).   "
190325|NCT00323882|"     Multicenter study in which patients with metastatic hormone refractory prostate cancer     (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010     every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at     escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be     enrolled in each dosage level. Patients who tolerated and responded to treatment or who had     stable disease for 3 months or longer and who subsequently progressed during the follow up     phase of the study had the option to receive additional treatment with MDX-010, up to 4     cycles. Patients were followed in the study for response up to 2 years and were followed for     survival status for up to 5 years after enrollment.   "
190326|NCT00323895|"     A Prospective, Randomized, Multi-Center Comparison of the Cypher Select™ Sirolimus-Eluting     Stent and Balloon Re-Angioplasty for Treatment of Patients with Intra-Des Restenosis.   "
190327|NCT00323908|"     A study to examine the correlations between methylation of various genes associated with     breast cancer and proliferation and cytomorphology in breast epithelial cells acquired by     random periareolar fine needle aspiration of women at high risk for development of breast     cancer.   "
190328|NCT00323921|"     The appearance of aged skin is a common cosmetic complaint of middle aged and older     individuals. This study evaluates the safety and efficacy of a new laser with cooling to     improve the appearance of aged skin. The laser being used will heat various depths of the     skin while protecting the outer layer.   "
190329|NCT00323934|"     In this study, MGCD0103, a new anticancer drug under investigation, is given three times     weekly to patients with advanced solid tumors or Non-Hodgkin's Lymphoma.   "
190331|NCT00323960|"     This is a 5-year project, involving 185 partners from 46 countries (110 in 21 EU States and     75 in 25 extra-EU States), with a randomised clinical trials (RCT) in juvenile     dermatomyositis (JDM): 5-year phase III single-blind, RCT in children with newly diagnosed     JDM: prednisone (PDN) versus PDN plus methotrexate (MTX) versus PDN plus Cyclosporine A. The     trial is aimed to find out the treatment regimen associated with the lowest occurrence of     flare and the lowest drug related toxicity   "
190332|NCT00323973|"     Chagas disease (CD) is the major cause of disability secondary to tropical diseases in young     adults from Latin America. In this region 20 million people are currently infected by T.     cruzi, the etiologic agent for CD. In Colombia, 18 percent of the population live in CD     endemic areas, 900,000 people are infected and over three million are at high risk of being     infected. Heart failure due to Chagas cardiomyopathy (CCM) is the main clinical form of CD in     Colombia. However, the incidence of CCM among T. cruzi infected people is unknown and the     mechanisms that lead from infection to CCM are uncertain. Besides the poor prognosis of CHF     due to Chagas disease, it is important to estimate the risk of complications and death in     patient infected with T. cruzi Unfortunately, few clinical studies have addressed this issue.     Most T. cruzi infected patients have mild or no clinical disease, however, the percentage of     infected people that will develop detectable cardiac abnormalities is approximately 30 to 40     percent, but only 20 percent of them will develop symptomatic cardiac involvement. Like CHF     from other causes, CHF due to CD responds to digital, diuretics and vasodilators therapy.     Also, some studies have shown that angiotensin-converting enzyme (ACE) inhibitors improve     survival in patients with moderate to severe CHF due to CD. Increased sympathetic drive     results in an increased risk of cardiac arrhythmia and sudden death. Beta-adrenoreceptor     antagonism seems to protect against the deleterious effects of chronic sympathetic     stimulation. The effects of the selective beta-adrenergic receptor blocker Bisoprolol on     cardiovascular mortality, hospital readmission due to progressive heart failure and     functional status in patients with CHF secondary to CCM has not been explored to-date. To     evaluate the benefit of Bisoprolol in CHF due to CCM, a cohort of T. cruzi seropositive     patients will be selected from several institutions in Colombia. Patients will be classified     according to a modified version of the Panamerican Health Organization recommendations for     patients with CCM. Overall one year mortality in patients with CHF due to Chagas disease has     been reported as 34 percent. However, one year mortality is only 3 percent in patients in     NYHA functional class II, 27 percent in those in NYHA functional class III, and 62 percent     among those in functional class IV (22). The sample size has been calculated assuming an     event rate of 40 percent in two years in the placebo group, and using a 95 percent confidence     level and power of 80 percent, we will need to recruit 250 patients per treatment arm to     detect a reduction of 30 percent in the risk of the primary outcome. The event rate we have     used to estimate sample size is similar to the expected two-year mortality in patients with     CHF due to Chagas disease in NYHA functional class II. Therefore, the estimated sample size     should be enough to measure significant changes in the composite primary outcome (death, HF     hospitalizations, SMVT, SCD). The recruitment process will follow guidelines set out by the     FCV Ethics Committee. Most participants will be recruited from the Chagas disease and the     Heart Failure clinics located in Bucaramanga, Bogotá and Cucuta. During the pretreatment     period an initial evaluation visit will be scheduled in which participants will sign consent     forms, baseline measurements and tests will be conducted at the FCV including blood pressure     measurements obtained with patients in the sitting and standing positions. Laboratory test     such as twelve-lead ECG will be recorded in each patient. Left ventricular ejection fraction     at rest will be determined by 2D echocardiography, using a modified Simpsons rule to     calculate LV volumes. Quality of life questionnaire will be performed two weeks apart during     baseline examination using the Minnesota living with heart failure questionnaire. Minimum of     two 6-minutes corridor walk test once a week over a two-week period will be performed to     measure the functional class. During the treatment period patients will be randomly assigned     to receive double-blind Bisoprolol or placebo, initially taking a total daily dose of 2.5     mgrs qd. The dose will be increased every two weeks to 5 up to 7.5 and 10 mgrs qd (maximum     maintenance dose). Follow-up assessment will include clinical check-up, and blood collection     for future measurements of inflammatory reactants and markers. Quality of life measurements     will be obtained at six months. Following the descriptive analysis we will compare the     patient survival and hospitalization rates using Kaplan-Meier estimates and survival graphs.     Cox regression will be used for the multivariate analysis of time to death and time to     hospitalization. This analysis will allow us to explore the pattern of changes in patients     with chronic heart failure due to Chagas disease such as the effect of beta-blockers in this     special type of cardiomyopathy.   "
190333|NCT00323986|"     Aims of the study        -  to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised          COPD patients        -  to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa          colonization and colony counts, and on reduction of the number of          exacerbations/hospitalisations, antibiotic courses and steroid use.        -  to evaluate the Quality of Life of patients treated and not treated with azithromycin,          using a validate Italian version of St George questionnaire        -  to evaluate the rate of chronic colonization with atypical pathogens        -  to evaluate the safety and tolerability of a long-term treatment with azithromycin,          including a survey on possible bacterial antibiotic resistance pattern variations   "
190334|NCT00323999|"     The aim of the study is to evaluate bipolar equipment versus monopolar, and to see if there     is any differences between the two types of bipolar equipment espescially regading both     safety and effect.   "
190335|NCT00324012|"     The trial is a phase II trial in adrenocortical carcinoma (ACC), a rare malignancy with poor     prognosis. It will provide results leading to the establishment of the effect of the included     drugs. The regimen consists of cisplatin plus taxotere. Over a period of 1-2 years this     national trial will include 19-36 patients with advanced ACC from different centres in     Denmark. Patients not responding to the first line treatment will be switched to the     alternative regimen. The primary objective of this trial is to investigate response rate.     Secondary endpoints are survival, time to progression, best overall response rate and     duration of response.   "
190336|NCT00324025|"     This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy     and safety trial to evaluate Mycograb®. Subjects will be randomized to receive either     Mycograb® (dosed 1 mg/kg) or placebo during the first week of induction therapy (amphotericin     B plus 5-flucytosine) via a central line or peripheral venous line twice daily for 7     consecutive days. The total duration of the study will be approximately 24 months.   "
190337|NCT00324038|"     The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with     standard- treatment in subjects with osteoarthritis (OA).   "
190338|NCT00324051|"     The purpose of the study is to estimate drug preference of stable schizophrenic patients who     will be treated with olanzapine orodispersible tablets for 6 weeks then with olanzapine     tablets for 6 weeks and vice-versa.   "
190339|NCT00324064|"     Specific Aim 1 Healthy male and female subjects and growth hormone (GH) deficient subjects     display sexually dimorphic GH responses to GHRH administration      Specific Aim 2 GH responses to GHRH in both healthy controls and in GH deficient patients     correlate with expression and activity of the stimulatory G proteins, G alpha q and G alpha     S. G protein levels correlate with gonadal steroid levels.      Specific Aim 3 Sexually dimorphic GH responses to GHRH are enhanced in Tanner Stage V     compared to Tanner Stage 1 individuals   "
190340|NCT00324077|"     The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is     safe, and whether the combination of the two drugs will help decrease the number of cells     that contain the Philadelphia chromosome.   "
190341|NCT00324090|"     The purpose of this study is to investigate the effect of a diet with either high or low     glycemic index (GI) on ad libitum (free) food intake, body weight, fat mass and fat-free     mass, risk markers for diabetes and cardiovascular diseases, energy expenditure and substrate     oxidation after 10 weeks´ intake in slightly overweight subjects.   "
190662|NCT00333931|"     The purpose of this study is to identify changes in brain functioning which are related to     reduced frequency and/or intensity of impulsive aggressive actions after treatment of     PTSD-related impulsive aggression with either phenytoin or cognitive behavioral therapy.   "
190342|NCT00324103|"     In the last years Structured Treatment Interruptions (STI) have been proposed to reduce     HAART-related toxicity and to increase patients’ compliance. ISS PART is a randomized     comparison of repeated STIs versus continuous HAART in chronically HIV-infected subjects with     persistent suppression of viral replication. The two arms of the study will be compared in     terms of immunological response (proportion of patients with CD4>500/mmc) at 2 years.   "
190343|NCT00324116|"     To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart),     of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in     patients with exudative age-related macular degeneration and evidence of recent onset,     subfoveal and/or juxtafoveal choroidal neovascularization.   "
190344|NCT00324129|"     In this study, MGCD0103, a new anticancer drug under investigation, is given three times     weekly to patients with leukemia or myelodysplastic syndromes.   "
190345|NCT00324142|"     This is a study of the drug tinidazole for women with recurrent bacterial vaginosis. Half of     the participants will get the drug for 10 days, the other half will get the drug for 10 days     and then twice a week for 12 weeks.   "
190346|NCT00324155|"     The purpose of this clinical research study is to examine the safety and effectiveness (how     well the drug works) of two different treatments for patients with melanoma. One treatment is     an investigational compound (a drug that is not currently approved by the United States Food     and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016)     together with an approved chemotherapy drug called Dacarbazine   "
190347|NCT00324168|"     The purpose of this study is to determine whether adding topical steroids improves the     outcomes of bacterial corneal ulcers, especially visual acuity.   "
190369|NCT00324467|"     The purpose of this study is to assess whether patients who are likely to fail R-CHOP, as     predicted by a mid-treatment PET scan, can have an improved outcome if switched to a standard     salvage regimen R-ICE (rituximab, ifosfamide, carboplatin, etoposide).      Patients who have a negative PET scan after 4 cycles of R-CHOP have an excellent prognosis     (>85% chance of cure) and should complete treatment with 6 cycles of standard R-CHOP.     Patients who have a positive PET scan after 4 cycles of R-CHOP have a very poor prognosis     (~10% chance of cure) and may have an improved outcome if switched to a non-cross resistant     chemotherapy combination R-ICE.   "
196470|NCT00421239|"     The purpose of this study is to determine whether frequent hypertensive urgencies increase     the risk of cardiovascular events in patients with arterial hypertension.   "
190348|NCT00324181|"     It is suggested the pathogenesis of normal-tension glaucoma (NTG) involves vascular     dysregulation. In the past studies, it is well documented that many physical problems related     to vascular dysregulation, such as angina pectoris (Friedman M et al 1974; Russek HI et al     1976), migraine (Diener HC et al 1994), primary Raynaud's disease (Wagner HH et al 1993) and     stroke (Gainotti G, et al, 2001; Hayee Ma et al 2001), are associated with a high risk of     depressive illness. So, NTG, being a disease involving vascular dysregulation, is postulated     to be associated with psychopathology.      Glaucoma increases after 40 year-old and the number of people over this age in Hong Kong is     rapidly growing. However, we have no knowledge about the link between psychopathology and NTG     in Hong Kong. The present study is sought to overcome the limitation in previous research and     the goals of present study are:        -  To identify the prevalence of psychopathology of normal-tension glaucoma Hong Kong          Chinese Out-patients attending a university-affiliated glaucoma clinic.        -  To determine whether there are any differences among NTG patients, patients with          glaucoma other than NTG and control in terms of psychopathology and quality of life.      Designs:      Case-control study to compare among patients with normal-tension glaucoma (NTG), patients     with glaucoma other than normal-tension glaucoma (OTNTG) and control in terms of     psychopathology and quality of life   "
190349|NCT00324194|"     In this study, MGCD0103, a new anticancer drug under investigation, is given twice weekly to     patients with leukemia or myelodysplastic syndromes.   "
190350|NCT00324207|"     The objectives of this study are to:        1. quantitate the level of insulin mRNA in the while cell fraction of whole blood in          selected groups of subjects,        2. determine the gene expression of markers of white cell activation in the white cell          fraction of whole blood in selected subjects,        3. determine the identity of the white cell responsible for expression of insulin mRNA and        4. determine protein expression of mRNA of insulin/proinsulin and selected genes of white          cell activation.   "
190351|NCT00324220|"     In this study, MGCD0103, a new anticancer drug under investigation, is given three times     weekly in combination with azacitidine to patients with high-risk myelodysplastic syndromes     or acute myelogenous leukemia.   "
190352|NCT00324233|"     Intermittent catheterization is a well-known method used for emptying the bladder. The     objective of this study is to compare the residual urine after intermittent catheterisation     with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized,     single blinded, crossover study including 24 healthy males.   "
190353|NCT00324246|"     -  In-vitro study        -  Collect data regarding the color appearance on the new developed indicator strips (NEW          NORMA-SENSE), in contact with vaginal secretion with elevated pH        -  Measure the buffering capacity of vaginal secretion from non-symptomatic and symptomatic          subjects        -  Detect these indicator strips' performance, in contact with urine   "
190354|NCT00324259|"     This study aims to examine whether estradiol is an appropriate for future Phase 3 studies as     second or third line endocrine treatment. In addition the protocol explores several     approaches to enhance the safety of estrogen therapy, including the establishment of the     efficacy of a lower dose than that currently recommended and through the early identification     of non-responders to avoid drug exposure in patients who are unlikely to benefit to estrogen     treatment.   "
190355|NCT00324272|"     The purpose of this study is to determine whether the use of fibrin sealant reduces     post-operative drainage following groin and axillary lymph node dissection.   "
190364|NCT00324402|"     To evaluate the maternal blood concentrations of brain natriuretic peptide (BNP) during the     second and third trimesters of a normal pregnancy. We will attempt to define a normal range     for pregnancy and any outliers that may serve as markers for abnormal cardiovascular     physiology.   "
190356|NCT00324285|"     Severe malnutrition is associated with a high rate of mortality, even when using the latest     WHO recommendations. Watery diarrhea as observed in cholera is an additional vital risk to     those children. The fragility of the children together with the complexity of the     pathophysiology and the simplicity of the medical environment where the treatment is     delivered are serious constraints for the development of new therapies. Dehydration is a     special immediate risk in those children who already displayed altered body distribution of     water with potassium, magnesium, zinc and other nutrient deficiency. Dehydration is also     often associated with a decrease in appetite. In addition, the intestinal function is altered     both by the infectious agent and the nutritional status of the child. Recommended therapy for     those children comprises oral rehydration with ReSoMaL (modified ORS for use in severely     malnourished children recommended by WHO), at a relatively low rate, with permanent     monitoring; in addition, breastfeeding should not be interrupted and feeding with F100 (Milk     based formula diet for use in severely malnourished children recommended by WHO) is     recommended. Recently, amylase-resistant starch added to a standard WHO-ORS has been shown to     reduce the duration and severity of adults with cholera. The rationale for using     amylase-resistant starch was that when starch enters the colon it is metabolized by the     bacteria. The short-chain fatty acids thus produced stimulate sodium absorption in the colon,     just like glucose stimulates water absorption in the small intestine. In addition, this     treatment would be of particular interest in malnutrition because short-chain fatty acids are     specific energetic substrate for the colon.In the present project, we propose to test the     hypothesis that addition of amylase-resistant starch to the already recommended treatment of     severely malnourished children with cholera reduces the severity and duration of diarrhea;     this could be achieved through the effect of short-chain fatty acids on colonic sodium     absorption. In addition, a better recovery from malnutrition could be achieved through the     energy provided by short-chain fatty acids to the colon and improved appetite through     improved rehydration. Thus, the aim of the study is to measure the effect of     amylase-resistant starch added to an already accepted treatment (with minimal changes) at the     rehydration and rehabilitation phases of the treatment. A total of 210 children aged 6 mo to     60 mo will be studied in three groups : a) glucose based ORS and amylase-resistant starch; b)     glucose based ORS without amylase resistant starch ; c) rice based ORS . The major outcome     variables on the first phase (diarrhoeal duration and stool output), and second phase (food     intake, weight gain) will be compared between the two treatment groups. The result of the     study if found effective in reducing the duration of diarrhoea, enhance recovery from     diarrhoea and malnutrition in severely malnourished children, will contribute to better case     management of these children.   "
190357|NCT00324298|"     RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells. It is not yet known which schedule of bleomycin is more effective when given together     with etoposide and cisplatin in treating metastatic germ cell cancer of the testicles.      PURPOSE: This randomized phase III trial is studying two different schedules of bleomycin to     compare how well they work when given together with etoposide and cisplatin in treating     patients with metastatic germ cell cancer of the testicles.   "
190370|NCT00324480|"     This phase I trial is studying the side effects and best dose of vorinostat when given     together with alvocidib in treating patients with advanced solid tumors. Drugs used in     chemotherapy, such as vorinostat and alvocidib, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may     also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Giving vorinostat together with alvocidib may kill more tumor cells.   "
190598|NCT00343941|"     This is a pilot study designed to determine a dose and schedule of Tucaresol that can be     administered to HIV-1 infected subjects on HAART (highly active antiretroviral therapy) with     viral suppression without occurrence of significant adverse events and that results in     significant changes in cell mediated immunity.   "
190358|NCT00324311|"     Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is     known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is     the source of local and/or systemic infection or sepsis. The local inflammation and infection     destroy healthy surrounding tissues and extends the original damage. In order to prevent     these complications, and in order to minimize the risk of infection, it is imperative to     evaluate the burn and remove all of the offending eschar at the earliest possible     opportunity. This removal of dead tissue is termed debridement.      The most direct debridement method for eschar removal is surgery. Traditional, conservative     non-surgical debridement is a lengthy process which often involves many complications.      The objective of this study is to evaluate the safety and enzymatic debriding efficacy of     Debrase Gel Dressing (DGD) in hospitalized patients with deep partial thickness and/or full     thickness thermal burns and to compare DGD to standard of care (SOC).   "
190359|NCT00324324|"     RATIONALE: A donor stem cell transplant can lower the body's immune system, making it     difficult to fight off infection. Giving antibiotics, such as moxifloxacin, may help prevent     bacterial infections in patients who have recently undergone donor stem cell transplant. It     is not yet known whether moxifloxacin is more effective than a placebo in preventing     bacterial infections in patients who have recently undergone donor stem cell transplant.      PURPOSE: This randomized phase III trial is studying moxifloxacin to see how well it works     compared with a placebo in preventing bacterial infections in patients who have recently     undergone donor stem cell transplant.   "
190360|NCT00324350|"     The purpose of the ACCORD-BONE Study is to investigate the effects of intensive glycemic     control for type 2 diabetes (in ACCORD participants) on factors related to bone health,     including, fractures, falls, and bone mineral density.   "
190361|NCT00324363|"     This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic     (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.   "
190362|NCT00324376|"     A randomized, cross-over, open-label study will be conducted to evaluate the equivalency,     safety and tolerability of sevelamer once per day dosing, given with the largest meal,     compared with standard three times per day dosing, in hemodialysis patients previously using     sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to     one of the following treatment sequences:        1. sevelamer dosed once a day with the largest meal followed by standard three times per          day dosing with meals        2. sevelamer dosed three times per day with meals followed by once a day dosing with the          largest meal. Patients will maintain a fixed daily dose throughout both treatment          periods based on the most recently prescribed sevelamer dose prior to screening.   "
190363|NCT00324389|"     This proposal seeks to use DNA analyses to understand how racial and genetic factors     influence interferon (treatment) response in HCV infection in African Americans. A better     understanding should allow rational design of new therapies or better use of existing     therapies. Patients will provide medical history and undergo a physical exam, blood draws,     electrocardiogram, possible chest x-ray, and abdominal ultrasound. Patients will be admitted     to the hospital for 5 days and undergo 2 liver biopsies, sedation, and multiple blood draws.     Twenty adult male volunteers (10 Caucasians,10 African Americans) ages 18 - 65 years will     participate.   "
190663|NCT00333944|"     The purpose of this study is to determine whether high doses of pralidoxime(PAM) are     effective as compare to lower doses of PAM in the management of moderately sever     organophosphorus poisoning patients.   "
190365|NCT00324415|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and cetuximab together with     radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and     cetuximab together with radiation therapy works in treating patients with HIV and stage I,     stage II, or stage III anal cancer.   "
190366|NCT00324428|"     This is a phase II study that aims to investigate prospectively a new therapy for a cohort of     patients with chronic pain attributed to pancreatic cancer. The justification of this study     is that the pain is the most important factor for the quality of life of these patients and     rTMS has been shown to be significantly associated with pain improvement in patients with     abdominal pain due to chronic pancreatitis. This therapeutic trial will be a 10-day,     randomized, parallel-group design, double-blind, incomplete cross-over, placebo controlled     clinical trial conducted at Beth Israel Deaconess Medical Center. The principal aim of this     investigation is the study of pain after a therapeutic intervention. The primary outcome is     pain reduction indexed by pain reduction and or analgesic intake reduction. The second aim of     the study is to assess the safety this new treatment in patients with pancreatic cancer. The     third aim of this study is to investigate whether rTMS treatment is associated with a change     in the activity of right secondary somatosensory cortex using magnetic resonance     spectroscopy. Because patients with locally advanced or advanced pancreatic cancer often     require increasing doses of narcotic pain medications, such as morphine, oxycodone and     fentanyl, in order to control their pain, adverse side effects are frequent observed in this     population of patients. Therefore rTMS treatment might represent a new therapeutic approach     that might be useful not only for pancreatic cancer but also to other types of cancer.   "
190367|NCT00324441|"     The purpose of the study is to evaluate whether mild walter-filtered near infrared     hyperthermia produces an additional benefit when applied as an adjunct to standard multimodal     rehabilitation compared to standard multimodal rehabilitation only in patients with     fibromyalgia.   "
190368|NCT00324454|"     Levetiracetam (Keppra) is used to treat partial onset seizures. Its biological effects     suggest it might also be useful in treating 3 aspects of human motor neuron diseases (MNDs)     for which no effective therapy exists: cramps, spasticity, and disease progression.   "
190599|NCT00343954|"     To evaluate PK and PD responses to L-citrulline given orally for four weeks to patients with     sickle cell disease who are otherwise healthy.   "
190371|NCT00324493|"     Hemophilia, which results from deficiency of factor VIII or IX, is a common hereditary     X-linked bleeding disorder affecting up to 10/100,000 population. About 60-70% of them have     severe disease (factor level <1%). This group is characterized by the occurrence of frequent     spontaneous bleeding into joints and soft tissues. If inadequately treated, it results in     progressive damage to joints and muscles leading to crippling deformities. Close clinical     observation of these patients over many years has shown that those with >1% levels have much     less bleeding compared to those with less than 1%. This observation has gained immense     clinical importance in planning therapy for these patients.      To prevent progressive joint damage, the missing factor needs to be replaced. Much has     evolved in this practice in the last 50 years. From administration of whole blood in the     beginning, to plasma and cryoprecipitate, to purified plasma-derived concentrates and finally     recombinant factor concentrates. The standard of therapy now is to replace factors frequently     enough to maintain >1% factor levels at all times (“prophylaxis”) or administer immediately     on premonition or earliest signs of bleeding (“on demand” therapy). This has greatly enhanced     the quality of life of people with hemophilia. However, the optimal regimens of factor     replacement remain to be defined. The definition of what is optimal management of this     chronic condition, currently incurable for the vast majority of patients, varies     significantly in different parts of the world, depending on practicality and social     expectations. Models have care have been developed in Western countries based on careful     documentation of outcome over many years. Such data is lacking from developing countries.      This multi-center study aims to systematically record the outcome of musculoskeletal function     in people with hemophilia in developing countries for the first time and provide information     that can help plan care for the 80% of all hemophiliacs in the world who live in these     countries. Currently there is no well documented model of care at the range of factor     replacement practiced in these countries nor is there any significant information on the     long-term outcome of musculo-skeletal function among these patients.   "
190372|NCT00324506|"     The primary objective of this safety/mechanistic study is to determine the safety and     tolerability of oral Cellcept when compared with weekly intramuscular Avonex in relapsing     multiple sclerosis. Safety will be assessed by virtue of changes in size and number of     lesions on MRI scans.   "
190373|NCT00324519|"     The purpose of this study is to compare two methods of pregnancy termination on the time to     delivery in the second trimester.   "
190374|NCT00324532|"     The study is an Open Label, Prospective, Non Comparative, Pilot, clinical trial design.     Patients with inadequate relief in GI symptoms associated with GERD despite PPI treatment     will be screened and those who meet the inclusion and exclusion criteria will perform a     glucose breath test for bacterial overgrowth . Each patient will then complete a     questionnaire to record their GERD related symptoms. Each patient will then receive a daily     intake of 30 mL two times daily, 30 minutes before meals for a period of 4 weeks. During the     course of the trial, they will have 4 visits with the study physician to assess treatment     compliance and occurrence of adverse events, and will complete periodic daily diaries to     record compliance.   "
190375|NCT00324545|"     (1) What effect does behavioral counseling for vegan, for low to moderate fat, and for     lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different     diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled,     maintain their modified behaviors after they have completed their diet program? (4) How does     targeting different diets affect secondary indices associated with heart disease such as     weight, lipid, inflammatory, and thrombotic factors?   "
190376|NCT00324558|"     Main objective:      To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26     weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases     progression-free survival.      Secondary objectives:      To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26     weeks, starting with the onset of chemotherapy, increases global survival, improving the     response rates to treatment with CT + RT (radiotherapy) and reduces the incidence of venous     thromboembolism (VTE).   "
190695|NCT00344565|"     The purpose of this study is to test whether a cognitive behavioral therapy (CBT) and a     medication called modafinil, which is approved to treat sleep disorders, will help     individuals who are abusing cocaine.   "
190377|NCT00324571|"     This is a randomized, open-label, parallel-design study to be conducted at 75 centers within     the United States. The study will be described to hemodialysis patients. Informed consent     will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be     randomized to receive either Renagel or a calcium-based binder.      Starting from the randomization date, mortality data including survival, death date and cause     of death (vital status information) and morbidity data including hospitalization date will be     recorded for all patients. These data will be collected until the end of the study (December     31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the     phosphate binder prescribed by their usual healthcare provider.   "
190378|NCT00324584|"     The purpose of this study is to determine if telecare using modern telecommunication devices     can improve the metabolic control and the quality of life of type 1 diabetic patients.   "
190379|NCT00324597|"     RATIONALE: AMG 706 may stop the growth of cancer cells by blocking blood flow to the cancer     or by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such     as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Giving AMG 706 together with gemcitabine may     kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of AMG 706 when given     together with gemcitabine in treating patients with advanced solid tumors or lymphoma.   "
190380|NCT00324610|"     Standard administration of capecitabine use a 14 days administration. Routine practice in     several intitution leads to use a 5 out of 7 days regimen, with less toxicity.      Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as     compared to the standard administration (14 days out of 21). The second end point is to     compare toxicity with either regimen.      Method : Randomized study with two groups : one with standard administration , the second     with 5/7 days regimen   "
190381|NCT00324623|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, may be used     to prepare the body for other treatments, such as cellular adoptive immunotherapy. Biological     therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in     different ways and stop tumor cells from growing. Vaccines may help the body build an     effective immune response to kill tumor cells. Giving cyclophosphamide together with     fludarabine followed by biological therapy may be an effective treatment for metastatic     melanoma.      PURPOSE: This phase I trial is studying the side effects of giving cyclophosphamide together     with fludarabine followed by cellular adoptive immunotherapy, and vaccine therapy in treating     patients with metastatic melanoma.   "
190404|NCT00336622|"     The purpose of this randomized clinical trial was to examine the efficacy of a splinting     (fabricated versus off-the-shelf splint)and exercise (nerve and tendon gliding versus no     exercise) interventions to alter the clinical course of Carpal Tunnel Syndrome (CTS). We     hypothesized that the fabricated splint with nerve and tendon gliding exercises condition     would yield the best functional outcomes at 4 and 8 weeks posttesting.   "
190382|NCT00324649|"     This study evaluated changes in body fat distribution in human immunodeficiency virus type 1     (HIV-1) infected participants who either switched from a zidovudine- plus lamivudine-     containing highly active antiretroviral therapy (HAART) regimen to a regimen containing     Truvada® (a fixed-dose combination tablet of emtricitabine [FTC, 200 mg] and tenofovir     disoproxil fumarate [TDF, 300 mg]) or who remained on a zidovudine- plus     lamivudine-containing regimen. Subjects continued their protease inhibitor (PI) or     nonnucleoside reverse transcriptase inhibitor (NNRTI).   "
190383|NCT00324662|"     A unique single-lead dual-chamber implantable cardioverter-defibrillator (ICD) system     (produced by Biotronik, Germany) features a conventional electrode in the ventricle (anchored     in the ventricular apex) and a floating electrode (ring on the lead body) in the atrium,     capable of sensing atrial electrical signals. The purpose of this study is to determine     whether this system detects a supraventricular tachyarrhythmia (e.g. atrial fibrillation,     atrial tachycardia) in the equivalent manner as conventional dual-lead dual-chamber ICDs     using two separate electrodes anchored in the ventricle and in the atrium, respectively.   "
190384|NCT00324675|"     Objective:      To evaluate how rosiglitazone does influence the renal plasma flow, the glomerular filtration     rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due     to overt diabetic nephropathy.      Background:      Diabetic nephropathy is a world wide public health concern of increasing proportions. It has     become the most common single cause of end-stage renal disease in the United States and in     Europe. Previous studies have already found agents modifying the renin-angiotensin-system     (ACE inhibitors and angiotensin receptor blocker) to retard diabetic nephropathy. These     agents are likely to exert multiple effects in the kidney. One of them appear to be their     known ability to improve endothelial function and to change renal glomerular hemodynamics.      In a previous study we demonstrated an improvement of renal endothelial dysfunction in type 2     diabetic patients without end organ damage after treatment with rosiglitazone. In that study,     rosiglitazone significantly reduced glomerular hyperfiltration. This was associated with a     reduction of urinary albumin excretion. The observed effects are potentially important in the     context of renal protection, provided that a similar beneficial effect of rosiglitazone is     demonstrable in overt diabetic nephropathy (renal insufficiency, hypertension, proteinuria).      Hypothesis Rosiglitazone decreases proteinuria and improves renal hemodynamic function in     patients with chronic renal insufficiency due to overt diabetic nephropathy.   "
190385|NCT00324688|"     This study looks at HIV-infected subjects who are on methadone treatment and medicines for     HIV.   "
190386|NCT00324701|"     The purpose of this study is to see whether therapy for elderly adults with major depression     can be delivered effectively using videoconferencing technology (telepsychology), which     allows a therapist and patient who are not in the same room as one another to communicate. We     are interested in learning if this form of mental health service delivery is an acceptable     alternative to traditional face-to-face therapy delivered with the therapist in the same room     as the patient.   "
190411|NCT00336713|"     The purpose of the study is to evaluate the long-term efficacy and safety of Saredutant in     patients with depression. The primary objective is to evaluate the efficacy and safety of     Saredutant 100 mg once daily compared to placebo in the prevention of relapse of depressive     symptoms in outpatients with major depressive disorder who achieved an initial response to 12     weeks of open-label treatment with Saredutant.   "
190387|NCT00324714|"     RATIONALE: Bisphosphonates, such as risedronate, may help improve bone health and prevent     osteoporosis in postmenopausal women. It is not yet known whether risedronate is effective in     improving bone mineral density and bone health in women with ductal carcinoma in situ.      PURPOSE: This randomized phase III trial is studying risedronate to see how well it works     compared to a placebo in improving bone mineral density and bone health in postmenopausal     women with ductal carcinoma in situ enrolled in clinical trial CRUK-IBIS-II-DCIS (CRUK:     Cancer Research UK) (DCIS: Ductal carcinoma in situ).   "
190388|NCT00324727|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     melphalan directly into the arteries around the tumor may kill more tumor cells. It is not     yet known whether hepatic arterial infusion with melphalan is more effective than standard     therapy in treating liver metastases due to melanoma.      PURPOSE: This randomized phase III trial is studying hepatic arterial infusion with melphalan     to see how well it works compared to standard therapy in treating patients with unresectable     liver metastases due to melanoma.   "
190389|NCT00324740|"     This phase I/II trial is studying the side effects and best dose of isotretinoin when given     together with vorinostat and to see how well they work in treating patients with advanced     kidney cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Isotretinoin may cause kidney cancer cells to look more like normal     cells, and to grow and spread more slowly. Giving vorinostat together with isotretinoin may     kill more tumor cells.   "
190390|NCT00324753|"     The immediate objective of this proposal is to assess the effectiveness of a multi-faceted     intervention to improve patient-provider communication about colorectal cancer screening in     improving patient adherence with colorectal cancer screening recommendations. This     intervention consists of: (1) guiding the communication process through patient activation to     initiate a colorectal cancer screening discussion; (2) optimizing communication content     through the use of a prompt sheet; and (3) cueing the provider to assess patient perception     of the communication. The long-term objective of our research program is to maximize     colorectal cancer screening rates throughout the VA through widespread adoption of clinically     feasible approaches to enhance patient-provider communication.   "
190391|NCT00324766|"     The purpose of this study is to determine the safety and efficacy of a 24 hour infusion with     levosimendan in patients with acute myocardial infarction and heart failure after acute     percutaneous coronary intervention (PCI) treatment.   "
190392|NCT00324779|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others     interfere with the ability of cancer cells to grow and spread. Giving rituximab before     chemotherapy may be an effective treatment for B-cell non-Hodgkin's lymphoma or B-cell acute     lymphoblastic leukemia.      PURPOSE: This phase II trial is studying how well rituximab works in treating young patients     who are planning to receive chemotherapy for B-cell non-Hodgkin's lymphoma or B-cell acute     lymphoblastic leukemia.   "
190393|NCT00324792|"     The primary objective of the study is to assess the effect of a 3-month intensive insulin     therapy on urinary leukotriene E4 (LTE4) excretion in patients with diabetes.   "
190394|NCT00324805|"     This randomized phase III trial studies chemotherapy and bevacizumab to see how well they     work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage     IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving more than one drug     (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as     bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab     also may stop the growth of non-small cell lung cancer by blocking the growth of new blood     vessels necessary for tumor growth. It is not yet known whether chemotherapy is more     effective with or without bevacizumab in treating non-small cell lung cancer.   "
190395|NCT00324818|"     We are trying to determine if longer duration of therapy with metronidazole or combination     therapy of metronidazole plus azithromycin results in better cure rates for BV   "
190396|NCT00330291|"     Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep     efficiency. It is FDA approved to treat cataplexy (drop attacks) associated with narcolepsy     (sleep attacks). It has been shown to be a safe and effective agent here where deep,     restorative slow wave sleep improves and next day cataplexy attacks tend not to occur.      Post Traumatic Stress Disorder (PTSD) is a psychiatric illness where a patient has witnessed     or been involved in a traumatic event. After the event is over, nightmares, flashbacks,     avoidance of people and places associated with trauma and hyperarousal occur which is     incapacitating to the patient. One major part of PTSD hyperarousal is marked insomnia with     multiple awakenings at night. This resultant poor sleep is compounded by use of SSRI     serotonergic antianxiety agents (ie Zoloft(sertraline)) as first line therapy which tend to     degrade slow wave, restorative sleep. Patients may respond to SSRI treatment but may fail to     remit as they continue to have sleep problems. PTSD patients will often fail to respond to     antihistamine (Desyrel (trazodone)) and benzodiazepine GABA hypnotic agents     (Restoril(temazepam)) and continue with poor, interrupted sleep. It is possible that Xyrem's     ability to remarkably improve slow wave sleep may greatly help treatment refractory insomnia     due to PTSD.      The author proposes an open-label study (no placebo) where 10 PTSD patients, who have failed     usual PTSD treatments and have failed usual insomnia treatments in particular will be given     Xyrem in addition to their current PTSD medication. The authors wish to determine if Xyrem is     a safe treatment optionin this difficult-to-treat patient population.   "
190412|NCT00336726|"     Traumatic Brain Injury (TBI) is a neurologic disorder cuased by physical trauma to the brain.     Neuroendocrine abnormalities in these patients have been reported, including central     hypogonadism within hours of the insult and eventual recovery of the     hypothalamic-pituitary-gonadal axis with recovery of cognitive function to baseline. This     pilot study will measure hormonal level of neuroendocine function at the time of TBI and     various time points during recovery.   "
190413|NCT00336739|"     The purpose of this study is to determine whether cinacalcet will increase gastric acid     secretion in healthy volunteers.   "
190397|NCT00330304|"     The study involves use of isoniazid and cotrimoxazole as strategies for preventing infections     in HIV-infected children and reducing mortality. Cotrimoxazole is well known to reduce     mortality and infections in HIV-infected children and is currently the recommended standard     of care. However, isoniazid has only been studied in HIV-infected adults (in whom it has been     shown to substantially reduce the incidence of tuberculosis). In a randomised controlled     study of isoniazid in HIV-infected children, the investigators found that INH reduced     mortality and tuberculosis incidence in excess of 50%; the data safety monitoring board     recommended termination of the placebo arm given the beneficial effects of INH. The     investigators therefore aim to follow-up these children to compare the long term impact of     two different INH and CTX preventive regimens (daily versus thrice weekly) on morbidity,     mortality, adherence and incidence of adverse reactions. The investigators also aim to     investigate the efficacy, safety and tolerability of INH compared with placebo for prevention     of TB in children receiving HAART as the benefit in this group is unknown.   "
190398|NCT00330317|"     The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy     with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive     primary breast cancer on tumour regression to permit breast conserving surgery.   "
190399|NCT00330330|"     The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of five     ISIS 113715 intravenous dose cohorts in drug-naïve type 2 diabetics.   "
190400|NCT00330343|"     This is an investigator initiated dose finding study designed to determine the optimal dose     of naloxone to prevent or minimize the most common side effects induced by opioids, namely     itching, nausea, and vomiting. Male and female inpatients of the Children's Center of the     Johns Hopkins Hospital, who are greater than 6 and less than 18 years of age with acute,     moderate to severe pain, and who are to be treated with intravenous Patient controlled     analgesia (IVPCA) morphine will be eligible for inclusion in this study. Patients will be     recruited by a study investigator prior to the initiation of IVPCA therapy. The majority of     patients will be post operative patients, and will start therapy and the investigational drug     in the Post Anesthesia Care Unit or the Pediatric Intensive Care Unit. The investigators plan     on studying between 10 and 99, male and female patients over a 2 year period.   "
190401|NCT00330356|"     High blood pressure is a global public health problem in developed and developing countries     including Pakistan. Various studies conducted around the world have linked salt intake to     variation in the blood pressure.However, definite conclusions are lacking and the exact role     of dietary salt in salt-blood pressure relationship remains controversial.      While clinical practice guidelines recommend dietary salt restriction for lowering blood     pressure, the relationship of salt with blood pressure has not been tested in the Pakistani     population. Therefore, the efficacy of dietary salt restriction on blood pressure of this     population remains to be determined. The study aims to determine the relationship between     dietary salt intake and blood pressure in Pakistani population. It is hypothesized that     alteration in the dietary salt intake demonstrates significant changes in the Systolic BP.   "
190402|NCT00330369|"     This is a research study of a new experimental drug called darusentan. Darusentan is not     currently approved by the U.S. Food and Drug Administration (FDA) for use in the United     States, which means that a doctor cannot prescribe this drug. The purpose of this study is to     determine if darusentan is effective in reducing systolic blood pressure in subjects with     resistant systolic hypertension, despite treatment with full doses of three or more     antihypertensive drugs, including a diuretic.   "
190403|NCT00330382|"     This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works     in preventing cancer in patients with oral leukoplakia. Chemoprevention is the use of certain     substances to keep cancer from forming, growing, or coming back. The use of Bowman-Birk     inhibitor concentrate, a substance made from soy, may keep cancer from forming in patients     with oral leukoplakia   "
190405|NCT00336635|"     The currently available stock of smallpox vaccine would be insufficient in the face of an     incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine is urgently     needed because previous manufacturing methods using calf lymph are no longer acceptable in     the view of current standards. Recently, CJ corporation in Republic of Korea has developed     cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by infecting MRC-5     cells. The aim of this phase 1 clinical trial were to assess safety, reactogenicity, and     immunogenicity of CJ-50300.   "
190406|NCT00336648|"     Primary Objective:      1. To assess resectability rate in patients undergoing gemcitabine plus Avastin-based     chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas.      Secondary Objectives:        1. To assess disease free survival and overall survival        2. To assess margin resection rate (R0 vs. R1) in these patients        3. To assess patterns of failure   "
190407|NCT00336661|"     This is a pivotal, prospective, randomized, blinded, multicenter study to evaluate two     treatments of photodynamic disinfection in adults with chronic periodontal disease. The study     is expected to enroll a total of up to 105 subjects.   "
190408|NCT00336674|"     In people with type 1 diabetes the beta cells of the pancreas no longer make insulin because     the body's immune system has attacked and destroyed the beta cells. It is thought that     exposure of the mucous membranes to insulin may cause act like a vaccine effect whereby     protective immune cells are stimulated and these then counteract the bad immune cells that     damage the beta cells. This study aims to determine if intranasal insulin can protect beta     cells and stop progression to diabetes in individuals who are at risk.   "
190409|NCT00336687|"     About 40 % of the patients in reanimation are thrombopenics and the causes are not well known     (reduction in platelet's production, increase in their destruction...). This protocol studies     the epidemiology of thrombopenia for these patients and the impacts of cost and mortality in     order to bring patients best medical cares.   "
190410|NCT00336700|"     Study Hypothesis: To estimate time to recurrence in pancreatic cancer patients treated with     adjuvant erlotinib and gemcitabine. Combination therapy will be given for 4 months followed     by single agent erlotinib for a total of 12 months.   "
190553|NCT00343291|"     The primary objective of this study will be to determine the progression free survival of     patients with stage IIIb/IV non-small cell lung cancer (NSCLC) treated with dual agent     monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with two     different regimens of paclitaxel and carboplatin chemotherapy.   "
190414|NCT00336752|"     The purpose of the study is to compare functional outcomes and recovery following surgical     and non surgical treatment of potentially unstable , isolated fibula fractures. Secondary     objectives are to compare the re-operation rate, time to union and complications between the     two treatment groups.      The primary research questions:        1. Does surgery provide a better functional outcome compared to non operative treatment of          undisplaced, unstable fractures?        2. Do patients with these fractures return to activities faster after operative or non          operative treatment?        3. Are complications more common with operative or non operative care?   "
190415|NCT00336765|"     The purpose of this study is to assess the safety and tolerability of the multiple receptor     tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given     orally daily to adults with advanced solid tumors.   "
190416|NCT00336778|"     We hypothesize that a simple bridging ARV regimen that tends to select for virus with a low     replicative capacity may tend to stabilize CD4 cell counts and HIV viral load and might be an     option to consider in patients with MDR HIV.      This strategy will provide them with the bridge they desperately need so that they can await     the development of new therapies that when used in combination will give them the best chance     in achieving complete virologic suppression.   "
190417|NCT00336791|"     Primary Objectives:        1. To prospectively evaluate the predictive accuracy of a previously discovered gene          expression profile-based test to foretell pathologic complete response (pCR) to          preoperative paclitaxel/FAC (5-fluorouracil, doxorubicin, cyclophosphamide) chemotherapy          for stage I-III breast cancer.        2. To evaluate if our genomic predictive test is specific to the paclitaxel/FAC regimen or          it also predicts increased sensitivity to FAC only chemotherapy.      Secondary Objectives:        1. To discover a molecular profile that is associated with pCR after FAC chemotherapy alone        2. To establish a prospectively collected gene expression profile data bank of breast          cancer for future studies        3. To compare the pCR rates between patients who receive 6 courses FAC and those who          receive sequential paclitaxel /FAC chemotherapies.   "
190418|NCT00336817|"     The objective of this study is to compare the safety and efficacy of Myfortic with CellCept     in liver transplant patients. Myfortic and CellCept are both immunosuppressive     (anti-rejection) drugs. CellCept is commonly used after liver transplantation but     gastrointestinal (GI) side effects are very common, sometimes necessitating in its     discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our     hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable     effectiveness to CellCept.   "
190419|NCT00336830|"     The purpose of this study is to determine the effect of a pre-discharge written personal     endorsement to the patient by the patient's attending cardiologist or cardiac surgeon (MD     endorsement) to take part in the Cardiac Rehabilitation and Secondary Prevention (CR)     program, in addition to the standard CR referral, compared to the standard CR referral alone,     on CR program enrollment within 2 months of index hospital discharge following admission for     myocardial infarction, unstable angina, coronary angioplasty, or coronary artery bypass.   "
190420|NCT00336843|"     In order to improve the clinical result of high-dose chemotherapy and autologous stem cell     transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning     regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan,     cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell     non-Hodgkin's lymphoma.   "
190421|NCT00336856|"     Research Hypothesis: Subjects in the study population who are treated with cetuximab in     combination with irinotecan will have higher response rates than subjects treated with     irinotecan alone.   "
190422|NCT00336869|"     The theme of this Morehouse-Emory Partnership Program focuses on elucidating the etiologic     basis of ethnic differences in obesity-related CVD and discovering new intervention     strategies to ameliorate CV health in all communities. The proposed Program uses a     multi-disciplinary strategy to systematically characterize ethnic differences in     obesity-related CVD by drawing upon the fields of physiology, psychology, biochemistry,     vascular biology, public health, nursing and clinical medicine.   "
190423|NCT00336882|"     Severe traumatic brain injury is associated with an increased production of free radicals     causing brain damage. First line treatment of these patients aims to maintain cerebral     perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties     that need to be confirmed when used in these patients. The main objective of this study is to     evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress     following severe traumatic brain injury.   "
190424|NCT00336895|"     The objective of this study is to determine the tolerability and safety of Myfortic in liver     transplant patients. Patients receiving CellCept who have GI side effects will have CellCept     discontinued and changed to Myfortic (Myfortic is a new drug similar to CellCept, except it     is enteric-coated). Our hypothesis is that Myfortic has less GI side effects and will,     therefore, be tolerated better than CellCept and also that Myfortic will have a comparable     effectiveness to CellCept.   "
190425|NCT00336908|"     This study is a blinded, randomized, controlled prospective trial comparing immune response     (sepsis, inflammatory response, pulmonary vasoconstriction) in 2 groups of infants less than     3-month old receiving pre and post cardiopulmonary bypass surgery. The infants will receive 1     out of the 2 following intravenous lipid preparations: Soybean Oil (n-6), or a combination of     Medium Chain Triglyceride i.e. coconut oil, Long Chain Triglyceride i.e. Soybean Oil, and     Fish Oil (MCT:LCT:FO). There will be 16 subjects in each group.   "
190426|NCT00336921|"     The primary objective of the study is to assess the efficacy of alfuzosin 10mg daily in the     return to successful voiding after removal of the catheter following a first episode of acute     urinary retention (AUR) in patients suffering from benign prostatic hyperplasia (BPH).   "
190427|NCT00336934|"     RATIONALE: Pomegranate extract may keep prostate cancer from growing in patients with rising     prostate-specific antigen (PSA) levels after surgery or radiation therapy for localized     prostate cancer.      PURPOSE: This randomized trial is studying how well pomegranate extract works in treating     patients with rising PSA levels after surgery or radiation therapy for localized prostate     cancer.   "
190554|NCT00343304|"     We will test whether robot driven, goal directed, trajectory corrected exercise enhances     motor outcome in the upper limb of stroke patients better than matched motor activity on an     upper body ergometer (monark).   "
190428|NCT00336947|"     RATIONALE: Drugs used in chemotherapy, such as S-1 and tegafur-uracil, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving S-1 or tegafur-uracil after surgery, chemotherapy, biological therapy,     and/or radiation therapy may kill any remaining tumor cells. It is not yet known whether S-1     is more effective than tegafur-uracil in treating head and neck cancer.      PURPOSE: This randomized phase III trial is studying S-1 to see how well it works compared     with tegafur-uracil in treating patients with previously treated stage III or stage IV head     and neck cancer.   "
190429|NCT00336960|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking blood flow to the tumor     and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such     as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to     kill tumor cells. Celecoxib may make tumor cells more sensitive to radiation therapy. Giving     celecoxib together with fluorouracil and radiation therapy before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving celecoxib together with fluorouracil     and radiation therapy works in treating patients with stage II or stage III rectal cancer     that can be removed by surgery.   "
190430|NCT00341536|"     This pilot study will examine the potential for health, diet and lifestyle research in Delhi,     Kerala, and Kolkota, India. It will: 1) evaluate the adequacy of the existing infrastructure     for a large-scale epidemiologic investigation and follow-up; 2) obtain a characterization of     the Indian diet; 3) determine study end-points; 4) evaluate the feasibility of collecting and     analyzing biologic samples within India; and 5) evaluate the ability of centers to recruit     subjects and collect data.      Indian men and women between 35 and 70 years of age who have resided in the study area     (Delhi, Kerala, or Kolkota) for at least 1 year may be eligible for this study. Participants     will undergo the following tests and procedures:      Part A: Diet and Lifestyle (2 visits)        -  Questionnaires on medical history and treatment practices, including questions on          reproductive history        -  Brief medical examination        -  Body measurements, including height, weight, forearm circumference, thighs, hips,          stomach, skin thickness of the back and triceps (back of the arms)        -  Blood draw for research, including studies of gene changes that affect the way the body          uses nutrients        -  Collection of toenail clippings for research tests        -  Interview about: 1) dietary habits and understanding of the relationship of diet to          health; 2) lifestyle, work, and family health; and 3) moving history (how often subject          has moved in the past 5 years, addresses of past homes, and plans for future moves)      Part B: Understanding Diet (6 visits)        -  Interview at each visit about food and drink consumed the day before the interview        -  2 blood draws        -  24-hour urine collection        -  Physical activity monitor. The subject wears a small device placed on the belt or waist          of the pants for a specified time to measure the amount of movement performed.      Part C: Medical Follow-up Patterns (1 visit)      -Answer questions about medical history, treatment practices, and dietary habits   "
190484|NCT00342277|"     The understanding of the biological mechanisms underlying preterm birth is very limited,     making prevention of preterm birth difficult. The incidence of preterm birth worldwide varies     between 6% to 11% in singleton pregnancies and 64-93% of preterm deliveries occur after the     spontaneous onset of labor (preterm labor) (1). The risk factors associated with preterm     birth include demographic variables such as ethnic group, past obstetric history, and     complications of the current pregnancy such as infection and fetal congenital anomalies. The     current study aims to investigate the basic mechanisms of preterm labor by systematically     cataloging the changes in expression levels of all expressed genes whose sequences are     available. The goals will be accomplished by using microarray technology followed by     quantitative real-time PCR, in situ PCR, in situ hybridization and proteomics.   "
190431|NCT00341549|"     This study will try to identify the gene or genes responsible for myopia (nearsightedness)     and to examine the relationship between myopia and near work. Myopia is the most common eye     disorder in the world, affecting one in four Americans. Several studies indicate that myopia     is inherited. The condition tends to cluster in families, so that studying families with this     condition may facilitate finding the exact cause.      Caucasian Americans and African Americans with myopia who are in general good health may be     eligible for this study. People with a family history of myopia through several generations     along one parent s side only, and in which more than one sibling has myopia are preferred.     People who have severe diseases that involve myopia, such as Stickler s or Marfan syndromes,     retinitis pigmentosa or diabetic retinopathy may not participate.      Participants will undergo the following tests and procedures:        -  Eye examination, including refraction        -  Blood draw for genetic studies and possibly establishment of cell lines (collection of          cells grown in the laboratory from an original tissue specimen) for future research        -  Myopia Family Study Questionnaire and personal medical information questionnaire to          provide information about other medical conditions that may influence the development of          myopia; the vision status of their spouse and children, parents and siblings, and spouse          s parents and siblings        -  Risk Factor Questionnaire (for Jewish Orthodox community only) to assess the amount of          near work activity done in childhood   "
190432|NCT00341562|"     This study, conducted in Argentina at the Hospital Espa ol de la Plata and the Hospital Franc     s de Buenos Aires, in collaboration with the NHLBI, will investigate possible genetic factors     that lead to in-stent restenosis. A stent is a wire mesh tube that is surgically placed to     open a blocked artery. The stent stays in the artery permanently, holding it open to improve     blood flow. In the case of blocked coronary arteries, the stent improves blood flow to the     heart muscle, relieving symptoms such as chest pain and shortness of breath. Sometimes     re-growth of tissue within a stent, called in-stent restenosis, leads to narrowing of the     artery, decreased blood flow, and a recurrence of symptoms. Genetic analysis may allow the     identification of patient that may be at increased risk for in-stent restenosis and lead to     methods of prevention and treatment.      Patients 18 years of age and older who are undergoing coronary endarterectomy (surgery to     remove plaque from an artery) to treat in-stent restenosis at the Hospital Espa ol de la     Plata and the Hospital Franc s de Buenos Aires may be eligible for this study.      Participants will have a blood sample drawn and undergo coronary endarterectomy. Tissue     removed from the patient's artery or the stent during surgery will be analyzed for gene     expression profiling and genotyping. The results will be studied along with information about     the patients' medical history.   "
190548|NCT00343226|"     The objectives of the study are:To compare the renal function of a quadruple     immunosuppressive regimen (including basiliximab in combination with an optimized     cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and     corticosteroids) versus a standard triple therapy regimen (including cyclosporine standard     dose, mycophenolate mofetil and corticosteroids)   "
190433|NCT00341575|"     This study, conducted by NHGRI and the M.D. Anderson Cancer Center in Houston, Texas, will     develop statistical approaches for modeling family social structure and apply these models to     explore the role of family social structure in participation in genetic testing and     counseling, disclosure of test results and adjustment to risk status. With recent genetic     advances and the ability to test for hereditary illnesses, methods that provide an     understanding of the family social structure and how that structure affects the dissemination     of genetic risk information are increasingly important.      The data for this study were collected by the M.D. Anderson Cancer Center as part of a study     on family communication and family functioning with regard to genetic testing for hereditary     nonpolyposis colon cancer (HNPCC). Relatives of people with HNPCC are more likely than the     general population to get colon cancer and other types of cancer if they have inherited the     gene alteration (mutation) that predisposes to the disease. This alteration can be passed on     from a parent to some or all of his or her children.      In the M.D. Anderson Cancer Center study, telephone interviews were conducted with 80 adult     members of 16 extended families with a known gene alteration predisposing for HNPCC. These     participants included people who had been diagnosed with an HNPCC syndrome cancer, their     unaffected family members who were at risk of carrying a gene mutation for HNPCC, and their     spouses. Participants were interviewed about their feelings, moods, coping style, and     relationships with their spouse, relatives, and friends, about their willingness to have     genetic testing, and about their feelings and beliefs about colon cancer, cancer screening     and genetic testing and counseling. Some participants were asked about their family     communication style and how the family coped with the idea of genetic testing and with the     results, if testing was done.      The information obtained from the current study may help facilitate family participation,     communication and psychological adjustment regarding risk information about genetic diseases.   "
190434|NCT00341588|"     The incidence of testicular germ cell tumors (TGCT) has increased during the twentieth     century and is of particular concern as it primarily affects young men. It is the most common     cancer among U.S. males ages 25-34. The only well-described risk factors are cryptorchism     (undescended testis), family history of TGCT, and personal history of TGCT. To better     understand the environmental and genetic determinants of TGCT risk, a case-control study will     be conducted among members of the U.S. armed forces. The study will include men who have     donated a blood sample to the Department of Defense Serum Repository (DoDSR) between 1989 and     2000. All DoDSR donors who have developed GCT will be matched to DoDSR donors who have not     developed TGCT. Approximately 1,080 men with TGCT, 1,080 controls, and 2,160 mothers will be     included in the study.      The DoDSR serum sample will be tested for organochlorines levels, gonadotropin levels, and     viral antibody titres. Each participant will donate a saliva specimen that will be used in an     examination of genetic susceptibility. Each participant will also complete a questionnaire     concerning a variety of possible risk factors such as physical activity, medical history,     medication history, and other risk factors. The mothers of all participants will be invited     to participate by completing a questionnaire concerning perinatal exposures and events and by     donating a saliva sample.      The three main objectives of this study are to:        -  determine whether environmental endocrine modulators (i.e., chlorinated pesticides and          polychlorinated biphenyls) are related to risk of GCT and, if so, whether their effects          are augmented by other risk factors.        -  determine whether genetic susceptibility to GCT exists and to characterize the          environmental risk factors related to that susceptibility.        -  determine whether there are distinct causes of GCT by relating the tissue structures of          the tumors to the risk factors.   "
190435|NCT00341601|"     This study, conducted in Korea, will examine why some people are more susceptible to     tuberculosis (TB) than others and why some strains of M tuberculosis (the bacteria that     causes TB) are more difficult to treat or become resistant to drug treatments. The study will     compare blood samples and other medical information from patients with different kinds of     tuberculosis and with healthy volunteers to identify patient and bacterial characteristics     that contribute to disease susceptibility, treatment failure, disease recurrence and     multi-drug resistance.      Healthy volunteers and patients with tuberculosis who are 20 years of age or older may be     eligible for this study. Subjects are recruited from among patients receiving treatment for     tuberculosis at the National Masan Tuberculosis Hospital in the Republic of Korea and from     healthy people visiting government health care centers for annual medical checkups. The     latter include people who have had TB but are cured; people who have been exposed to TB, but     currently have no signs of disease; and those who have not been exposed to TB.      Participants with tuberculosis undergo the following tests and procedures:        -  Medical history, including past treatments for TB, and review of medical records        -  Interview about home and work        -  Sputum collection to test for the kind of TB bacteria present and for genetic studies of          the bacteria        -  Drug treatment for TB        -  Blood draws as part of regular patient care, for HIV testing, and for genetic studies        -  Chest x-rays as part of routine patient care        -  In patients with recurrent disease, examination of the strains from both bouts of          disease to determine if it is a recurrence of the same organism or infection with a new          strain.      Healthy volunteers undergo the following tests and procedures:        -  Brief medical history        -  Blood draw to look for exposure to TB and for genetic studies        -  Review of previous x-ray to look for active TB   "
190576|NCT00343616|"     RATIONALE: Studying cognitive function, such as thinking, attention, concentration, and     memory, in postmenopausal women receiving hormone therapy for breast cancer may help improve     quality of life and the ability to plan treatment for cancer.      PURPOSE: This phase III trial is studying cognitive function in postmenopausal women with     breast cancer receiving hormone therapy on clinical trial IBCSG-1-98.   "
196520|NCT00412204|"     The purpose of this study is to determine the effect of treatment with tiotropium bromide on     efficiency of gas exchange and exercise performance in COPD subjects during exercise.   "
190436|NCT00341614|"     Type 2 diabetics (non-insulin-dependent) are more than five times as likely to suffer an     initial myocardial infarction (MI; heart attack) compared to nondiabetics.Female diabetics in     particular, have a higher mortality rate for coronary artery disease (CAD) than male     diabetics.C-reactive protein measurement in the clinical setting enhances the detection of     individuals who are at high risk for cardiovascular disease (CVD), by providing additional     predictive value.      We propose to study the effects of a supervised exercise and diet intervention on     cardiovascular disease risk in postmenopausal diabetic women. We will recruit 35     postmenopausal, sedentary type 2 diabetics who will undergo a 3 month exercise and dietary     intervention. They will exercise 3 times a week for 30 min in a supervised setting. Exercise     mode will be aerobic and self-selected (i.e. treadmill, bike) at an intensity level of 50-85%     VO2peak. Blood glucose will be monitored before and after exercise. The dietary intervention     will consist of 6 meetings with a registered dietitian.      The study is designed to test the following hypotheses:        -  Cardiovascular disease risk measures will be different following a 3-month exercise and          diet intervention.             -  H1: Blood markers for coronary artery disease risk, as measured by CRP, TC, LDL,               TG, FG, fasting insulin, and HbA1c, will be different following a 3-month exercise               and diet intervention.             -  H2: Anthropometric measures of coronary artery disease risk, as measured by WHR,               will be different following a 3-month exercise and diet intervention.             -  H3: Resting blood pressure, as measured by SBP and DBP, will be different following               a 3-month exercise and diet intervention.             -  H4: Total body fat, as measured by DXA, will be different following a 3-month               exercise and diet intervention.        -  Health-related measures will be different following a 3-month exercise and diet          intervention.             -  H1: Cardiorespiratory fitness, as measured by maximal oxygen consumption (VO2max)               will be different following a 3-month exercise and diet intervention.             -  H2: Bone-mineral density, as measured by DXA, will be different following a 3-month               exercise and diet intervention.             -  H3: Dietary measures (total daily kcal, and daily fat kcal) will be different               following a 3-month exercise and diet intervention.   "
190437|NCT00341627|"     Chordoma is an uncommon (400 case/year in the U.S.) and potentially fatal bone tumor derived     from remnants of embryonic notochord. It occurs primarily in the axial skeleton and has a     mean age at diagnosis of 55 years, with a range from early childhood to over 70 years. This     tumor usually presents at an advanced stage and the associated mortality is high due to local     destruction and distant metastases. Chordoma is rare in African-Americans and is typically     sporadic; there are few reports of these tumors arising congenitally or within members of the     same family.      Recently, we have identified and studied one large family in which 10 relatives in three     generations have chordoma; the inheritance pattern suggests transmission of a mutation in an     autosomal dominant gene. Using information from this family, we have tentatively napped this     gene to the long arm of chromosome 7. To confirm this finding, and to fine map and clone the     gene, we need to study additional chordoma families. In an effort to identify such families,     we have developed collaborations with four SEER registries covering the populations of     Detroit, Los Angeles, Iowa, and New Mexico. Each registry will identify all chordoma cases     diagnosed since 1988 and invite them (or the next of kin of deceased cases) to participate in     our study. Through 1997, the registries have identified a total of 140 chordoma cases, 96 of     whom are living. The registries will invite these patients (or their next of kin) to     participate in the study. The study components include completion of a self-administered     personal and family medical history questionnaire, retrieval of medical records and pathology     reports pertaining to chordoma, and collection of paraffin-embedded chordoma tissue and     buccal mucosal cells for genetic studies. NCI will carry out all the data collection     activities for the study subjects identified through the Detroit registry. NCI will also     conduct the buccal cell collection component of the study for all patients identified by the     other three registries. These three registries will carry out all other study activities on     these patients/next of kin and will send the data and slides prepared from the paraffin     blocks to NCI. NCI will analyze the questionnaire data to determine if any unusual patterns     of cancers other than chordoma or other medical conditions appear to cluster in families of     the chordoma patients. Selected members of any families with two or more relatives with     chordoma will be invited to participate in a separate clinical and molecular study conducted     at NIH to try to identify the chordoma gene. DNA from the buccal cells and tumor blocks from     all other patients with sporadic chordoma identified through the registries (likely to     comprise most patients) will not be studied until we or others have identified such a gene.   "
190438|NCT00341640|"     This study will provide information regarding the optimal dose and duration of nicotine     replacement using the nicotine patch for a smoking cessation study of pregnant     African-American women. Previous studies have shown that pregnancy, race and ethnicity can     affect the way people metabolize nicotine. The information from this study may help     scientists develop ways to help pregnant African-American women quit smoking and not start     smoking again after delivery.      African-American women 18-30years of age who are in the second trimester of a healthy     pregnancy, who are carrying only one baby and who smoke 10 or more cigarettes a day may be     eligible for this study. Candidates are screened with a medical history, physical examination     and urine test. They receive counseling to help them quit smoking. Those who cannot quit     smoking within 7 to 10 days after receiving counseling may be invited to join the study.      Participants are admitted to a private room in the Pediatric Clinical Research Center at     Children's National Medical Center in Washington, D.C., for 48 hours, during which time they     are not permitted to smoke. After a wash out period, a nicotine patch will be applied     according to these doses and schedules:        -  21 mg patch for 24 hours        -  21 mg patch for 16 hours        -  14 mg patch for 24 hours        -  14 mg patch for 16 hours      An intravenous (IV) line is placed in the subject's arm and 12 blood samples are drawn     through the line at intervals during the 48 hours. Twleve urine and saliva samples are also     collected. Blood, urine, and saliva samples are analyzed for nicotine and cotinine (a product     of nicotine metabolism) levels, and DNA will be collected studied for genes that are     associated with nicotine and cotinine metabolism. Participants are interviewed about their     urges to smoke, quality of sleep, etc.   "
190439|NCT00341653|"     We propose to add a collection of buccal cells to a school-based cohort of 7th graders in     Wuhan, a large industrial city in China. The cohort study is being conducted by the Wuhan     Public Health and Anti-Epidemic Station (Li Yan MD, director and principal investigator). The     cohort study is designed to look at several outcomes. One is initiation of smoking. The     second is respiratory health in relation to active and passive smoking and other     environmental exposures that are prevalent in Wuhan. The respiratory outcomes include changes     in pulmonary function, asthma and other respiratory symptoms. Collection of buccal cells is a     noninvasive method of obtaining DNA. The addition of a genetic sample will enable us to     examine candidate gene associations for asthma and childhood respiratory illness within an     interesting and well-characterized Chinese population. In addition, it provides the     capability to examine gene environment interaction with respect to common environmental     exposures in Wuhan. The ability to examine gene-environment interaction can help to identify     relatively subtle effects of pollutants such as environmental tobacco smoke which is becoming     a very common exposure due to the major increase in smoking among Chinese men. Other     exposures of interest in Wuhan are indoor coal burning and high ambient exposures to     particules, ozone and nitrogen oxides. The proposed study has been approved by the human     subjects committee of the Wuhan Public Health and Anti-Epidemic Station.   "
190440|NCT00341666|"     This study, conducted by NIH and the University of Bamako in Mali, Africa, will study the     effect of concurrent infections with malaria and filariasis on patients' immune response.     Lymphatic filariasis is caused by infection with very small parasitic worms called Wuchereria     bancrofti that are acquired from mosquitoes. The worms may cause no illness in many who are     infected, but is some, they can cause swelling of the arms, legs, breast and genitalia, which     may progress to permanent swelling referred to as elephantiasis. Malaria is caused by     Plasmodium falciparum, another parasite that is spread by mosquitoes. It can cause fevers,     headaches, body aches and weakness, and, if untreated, it can cause severe illness and death.      The 8-month study will analyze measures of immune function in blood cells from people with or     without filarial infections who become infected with malaria. The goal of the studies is to     see if having a filarial worm infection affects immunity against malaria. Results of analysis     of immune function in persons with malaria but without filaria infections will be compared     with those harboring both filaria and malaria infections and also with results from healthy     control subjects.      Healthy individuals and patients with malaria and filarial infections between 1 and 8 years     of age and between 18 to 65 years of age who live in N'Tessoni and healthy individuals living     in Bamako, Mali (controls), may be eligible for this study.      Participants have blood samples collected as follows during the study:        -  A blood sample will be collected at the beginning of the study. Individuals found to          have the filarial worm infection have a second sample drawn at nighttime when the          filarial worms are present in the blood. Treatment for filaria infection will be offered          to all infected individuals at the end of the study.        -  A second sample will be collected during malaria season. Subjects will be interviewed          about their health during the malaria season and re-tested for filarial and malaria          infections with a finger-prick test. Those who test positive for malaria will be offered          treatment to begin immediately after collection of the donated blood sample..        -  A third sample will be collected after the end of the malaria season. Subjects will be          interviewed again about their health and re-tested for filarial and malaria infections          with a finger prick test. Those who have positive results for either infection will be          offered treatment after collec...   "
190577|NCT00343629|"     RATIONALE: Giving healthy volunteers sulindac capsules or sulindac tablets may help doctors     learn which form of the drug may be more effective in preventing cancer.      PURPOSE: This randomized clinical trial is studying sulindac capsules to see how well they     work compared with sulindac tablets in healthy volunteers.   "
190441|NCT00341679|"     This study will define the major genetic risk and protective factors for idiopathic     inflammatory myopathies (IIM), a group of immune disorders affecting connective tissues such     as muscles. It will also identify new environmental risk factors for IIM and identify immune     responses in myositis and related diseases. There are many forms of IIMs, and the causes of     these diseases are unknown. However, scientists suspect that they result when people with     some genetic factors that predispose them-that is, put them at greater risk-are exposed to     certain environmental triggers. Some of those triggers include food, drugs, biologics (such     as a vaccine to prevent disease), medical devices and occupational exposures.      Patients, including children under 18, who had a diagnosis of myositis, a related autoimmune     disease, or a rheumatic disease, as well as their blood relatives, and control subjects who     were in good health have already been recruited for this study.      The evaluation consisted of one outpatient visit to the patient's doctor, who will obtain a     medical history and conduct a physician examination. Patients spent 20 to 30 minutes to     answer written questions. There was a blood collection of about 6 tablespoons. If there was a     major change in patients' medical conditions, they were asked to return for a second     outpatient evaluation to determine whether any of the blood tests or antibodies, which show     an immune response, had changed. Blood samples collected will be used only for laboratory     research studies. The samples have been identified by a code, and all other identifying     information have been removed.      During the study, researchers will explore possible environmental risk factors, including     studies of infectious and non-infectious agents. They will analyze the blood for genetic     markers and test for certain antibodies. Laboratory results will be evaluated as they relate     to the signs, symptoms, and severity of patients' illnesses. That would help researchers to     better understand patterns of the diseases and the outcomes for patients.      This study will not have a direct benefit for patients. However, results from the study can     be made available to patients' doctors for use in appropriate care. Also, it is hoped that     information gained can help other people in the future.   "
190442|NCT00341692|"     Breast cancer is the most common cancer among women in the United States. Breast cancer     research has been hampered by the difficulty in collecting normal breast tissue. In this     study, researchers will obtain samples of normal breast tissue from organ donors and will     collect risk-factor data from next-of-kin.      The purpose of this study is to learn how normal breast develops and responds to stresses     that are known to increase a woman s chance of developing breast cancer.      Following the breast-tissue donation from 20 volunteers, surgical technicians will make small     incisions in the skin and tissue of the breast and remove several samples measuring about     one-inch. Technicians also will take samples of the uterine lining to estimate the date of     the last menstrual period. The tissue will then be sent to the National Cancer Institute for     laboratory research studies. Steps will be taken to ensure that the identity of the     participants remains confidential.   "
190549|NCT00343239|"     Study objectives:      To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the     treatment of neoadjuvant gastric carcinoma.   "
190550|NCT00343252|"     The purpose of the study is to determine if daily teriparatide reduces back pain more     effectively than weekly risedronate in women with osteoporosis who have chronic back pain due     to a spinal bone fracture.   "
190443|NCT00341705|"     The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively     follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus     (HCV). The vast majority will have been infected with HCV, and approximately 1/3 will have     been infected with human immunodeficiency virus (HIV). Primary objectives are to quantify the     rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to     evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are     likely to be on the causal pathway for these conditions. Candidate clinical and laboratory     markers will be examined longitudinally to define changes over time and their relationships     to one another. Collaborative studies will focus on genome scanning and evaluation of     candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the     diseases that result from these infections. Additional studies will identify response and     complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive     clinical care of persons with hemophilia.   "
190444|NCT00341718|"     This study will describe the experience of patients with visible physical abnormalities in     the genetics clinic when they are involved in teaching others about their condition.     Information from this study may be used to enhance educational experiences in genetics     clinics.      Patients 18 years of age and older with a visible physical anomaly who have been seen by a     genetics professional in the past 5 years may be eligible for this study.      In a tape-recorded telephone interview, patients are asked about the following:        -  Their experiences when visiting the genetics clinic        -  The circumstances under which they have been approached to participate in teaching          others        -  Their perspective on specific teaching behaviors used in genetic consultations, and how          this perspective is affected by their perception of their own visible difference        -  The benefits and downsides of being involved in teaching others        -  The circumstances under which they feel comfortable being approached by genetics          providers to help teach others about their condition        -  The conditions or circumstances that make some individual teaching experiences better or          worse than others   "
190445|NCT00341731|"     Polycystic Ovary Syndrome (PCOS) is manifested as a heterogeneous mixture of clinical and     bichemical characteristics that complicate study of its etiology. It is currently unclear to     what extent PCOS-associated traits (hyperandrogenism, hyperinsulinemia, insulin resistance,     type 2 diabetes, dyslipidemia, hypertension, obesity, and coronary artery disease) are the     result of environmental factors or genetic predisposition. We propose to conduct a twin study     to investigate the possibility that environmental factors are important in the development of     the PCOS phenotype. Twin studies are considered to be the gold standard for determining the     extent of heritability of a trait. The proposal described here is only for Step 1 of a     larger, multi-step study. The major goal of step 1 is to identify a large cohort of twin     pairs, in which at least one member of each pair is likely to have PCOS.      Participants for this study will come from the Mid-Atlantic Twin Registry (MATR). Many (3283)     potential participants have already been identified based on their answers to a preliminary     MATR screening questionnaire. Out of the approximately 7145 twin women of reproductive age     who completed these MATR screening questionnaires, 1803 women reported irregular periods, 954     reported ovarian cysts, and 526 reported both irregular periods and ovarian cysts. Many of     the women in this last group are likely to have PCOS. They represent 7.4% of the total     sample, matching current estimates of PCOS prevalence (4-7%) in reproductive age women. We     will also add new twin pairs who meet the criteria (irregular periods and evidence of PCOS or     cystic ovaries) as they are recruited into the MATR and take the preliminary surveys.     According to MATR statistics, about 33% of twin pairs are monozygotic (MZ, identical).     Therefore, approximately 174 of the 526 women likely to have PCOS are members of a MZ pair.      Step 1 of the proposed study consists of a telephone survey of the 3282 women with irregular     periods and/or ovarian cysts. The survey will be conducted by the MATR. The instrument to be     used contains a series of simple and direct questions and will take about 10 minutes to     complete. The questions were designed to identify PCOS and their content deals with the     frequency of menstrual periods (six or fewer per year being a major diagnostic criterion), a     previous diagnosis of PCOS, obesity, excess facial hair and other evidence of     hyperandrogenism. The women will also be asked if t...   "
190446|NCT00341744|"     Providing Access to the Visual Environment is a pediatric low vision grant which has the     ability to provide comprehensive, interdisciplinary low vision rehabilitation services to     every child in Tennessee with a vision impairment. Children, ages 3-21, with best-corrected     vision of 20/50 or worse in the better seeing eye are prescribed optical devices to improve     their visual functioning and trained to use the devices.   "
190578|NCT00343642|"     Our objective is to determine whether a specific dietary intervention or a     fructooligosaccharide (FOS) supplement has anti-oxidant or prebiotic effects and whether it     is beneficial in the treatment of Crohn's Disease (CD.   "
190447|NCT00341757|"     Family history of cancer is an important possible indicator of inherited cancer     susceptibility, which has helped identify individuals and families at high risk of inherited     cancers in research studies and clinical practice. While there are also various potential     uses of family history of cancer data in cancer surveillance, the completeness and accuracy     of family history of cancer data collected from the general population is unclear. In an     effort to evaluate the feasibility of conducting a national surveillance study to determine     the prevalence of family history of cancer in the U.S. population, the Risk Factor Monitoring     and Methods Branch will undertake a pilot study, entitled the Family Health Study, that     examines issues of data quality. In this study, a family history of cancer questionnaire     (FHCQ) will be developed for surveillance purposes and administered to a random digit dial     (RDD) sample of households in the state of Connecticut. Positive and negative reports of     common cancers in the respondent's families will be validated against records of the     Connecticut Tumor Registry (CTR) and other data sources.      The objectives are to: 1) assess the agreement between respondent reports of specific cancers     in first and second degree relatives and medical record-based reports, as measured by percent     concordance; 2) quantify the sensitivity, specificity and predictive value of the FHCQ by     cancer site; 3) evaluate the possible predictors of reporting accuracy, including cancer     site, year of diagnosis, kinship relation of the relative to the respondent and the frequency     and quality of their contact, overall family cohesiveness, respondent's own history of     cancer, and demographic factors; 4) describe the completeness and reliability of family     structure data.      Validation of selected relatives' cancer status will be done through data linkage to the     Connecticut Tumor Registry, other selected cancer registries, the National Death Index,     Medicare claims data bases, state death certificate registries, or by obtaining consent to     review available medical records from physicians and health care facilities. Self-reports of     respondents' cancer status will also be validated since this may be a predictor of ability to     accurately report family history. A pre-established tracing algorithm will be used to triage     cancer reports into the medical records systems where true cancer status is most likely to be     verified by the highest quality data. Validated cancer outco...   "
190551|NCT00343265|"     The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm     birth in women carrying 2 or more babies.   "
190552|NCT00343278|"     Valaciclovir (VACV), the L-valyl ester prodrug of aciclovir (ACV), is extensively converted     to ACV and L-valine after oral administration. In subjects with normal renal function, ACV is     predominantly eliminated unchanged in the urine, with a small proportion metabolized to     9-carboxymethoxymethylguanine (CMMG). The metabolism of ACV to CMMG is thought to involve     aldehyde dehydrogenase (ALDH). On the basis of a high proportion of the Japanese population     having low-activity ALDH, it can be hypothesized that the conversion of ACV to CMMG is     decreased, thereby leading, in patients with renal impairment, to higher plasma     concentrations of ACV. This pilot study was conducted to investigate potential relationships     between genetic polymorphisms of ALDH2, an isozyme of ALDH, and the plasma pharmacokinetics     (PK) of VACV, ACV and CMMG in subjects with end-stage renal disease on hemodialysis.   "
190448|NCT00341770|"     Obesity is the consequence of an imbalance between energy intake and energy expenditure.     Recent studies have suggested that the sympathetic nervous system (SNS) may be an important     determinant of the rate of energy expenditure in man. Indirect assessments of the sympathetic     nervous activity in Pima Indians have recently shown impaired SNS-mediated energy expenditure     in this obesity-prone population. We plan to perform direct microelectrode nerve recording of     the sympathetic innervation of the lower leg to directly assess SNS activity and examine its     potential role in the regulation of metabolic rate and the development of obesity.     Measurements will be performed in the basal state, in response to glucose feeding (75 g OGTT)     and in response to glucose/insulin infusion. These studies also will help to disassociate the     effect of insulin and glucose on the stimulation of SNS activity. Energy expenditure     measurements will be performed over 24 hours in the respiratory chamber and for 2 1/2 hours     before and during the euglycemic clamp. Results also will be used to determine possible     racial differences between Pimas and Caucasians, since the risk for obesity is markedly     different in these populations. To exclude the possibility of a normal SNS activity but     with peripheral resistance to the action of norepineprine, we will perform adrenergic     stimulation by isoproterenol to measure peripheral adrenergic sensitivity.   "
190449|NCT00341783|"     There are about 300-500 million cases of malaria worldwide each year, with 2-3 million     deaths. Plasmodium falciparum, one of four types of malaria, is responsible for most of these     deaths. Because of increasing resistance of this parasite to drugs and of mosquitoes to     insecticides, a vaccine would be valuable in the fight against malaria.      Don gu bougou, Mali, is an area of seasonal malaria transmission that is being investigated     as a possible suitable site for testing investigational malaria vaccines. The goal of this     study is to characterize the population of this site in terms of common hematologic (blood)     and biochemistry parameters that may be used to determine eligibility for participation in     vaccine trials. The study will also assess the prevalence of preexisting medical conditions     that might affect assessments of vaccine safety and efficacy. Also, the natural immunity to     antigens in the investigational malaria vaccines will be determined.      Don gu bougou, Mali, was chosen because of its high malaria rates. Data will be collected at     four time-points. At least 50 individuals will be recruited from each of the following age     groups: 6 months-5 years; 6-10 years; 11-15 years; and 16-45 years. Village-wide consent will     be obtained and about 25 of the 111 family compounds will be randomly selected. Individual     consent will also be obtained.      Enrolled volunteers will undergo a baseline medical history and physical examination. Blood     will be collected for various tests, and, for women of childbearing age, urine pregnancy     tests will be administered.      At each of three followup visits, a brief medical history and physical exam will be     conducted. Blood will be drawn for tests. Also, blood, urine, and/or stool tests not done at     baseline will be done at one of the followup visits.   "
190450|NCT00341796|"     This study, conducted in Tamil Nadu, India, was initiated in response to the developing     epidemic of HIV/AIDS in India. It is divided into two stages, as follows:      Stage I      All women registered in the pregnancy clinics at the Namakkal District Hospital or the     Rasipuram Government Hospital in the state of Tamil Nadu in India will be offered     participation in an educational session on HIV infection and transmission. It will include a     pre-educational assessment of knowledge, attitudes, and beliefs, and a post-educational     assessment of knowledge about HIV infection and transmission. All women at the clinic,     regardless of whether or not they participate in the educational and assessment sessions,     will be offered HIV counseling and testing. The objectives of this stage of the study are to:        -  Assess the acceptance of education about HIV infection and transmission among pregnant          women at the participating sites and their knowledge, attitudes, and beliefs about HIV        -  Assess the acceptance of voluntary counseling and HIV testing among pregnant women at          these sites        -  Determine the prevalence of infection among women who accept HIV testing at these sites      Stage II      Pregnant HIV-infected women at the pregnancy clinics at the Namakkal District Hospital or the     Rasipuram Government Hospital who are 18 years of age or older will be offered enrollment in     Stage II of this study. Participants will be followed during their pregnancy and until their     baby is a year old. The baby will be a part of the study from birth to one year of age. After     delivery, both the mother and baby will be followed with regularly scheduled visits that     include a physical examination and blood test.      Treatment with the anti-AIDS drug zidovudine will be offered for both the mother and child.     For the study protocol, the mother will receive the drug starting the 28th week of pregnancy     and continuing through labor and delivery. The infants will start drug treatment within the     first 24 hours of life and continue for 6 weeks. Women who do not choose to take zidovudine     according to this schedule will be offered standard treatment with a shorter course of drug,     beginning with the 36th week of pregnancy, and no preventative treatment for their infants.     All women will be offered education and counseling about the risks and benefits of     breastfeeding and the risk of HIV transmission through breastfeeding. The objectives of this     stage of the study are to:        -  Assess the safety and tolerability of zidovudine given according to this protocol        -  Assess the acceptance of and adherence to the zidovudine regimen in the protocol        -  Assess the acceptance of education and counseling about breastfeeding        -  Determine the mother-to-child HIV transmission rates in this study        -  Determine the rates of illness and death through 12 months after delivery        -  Determine risk factors for mother-to-child transmission of HIV   "
190451|NCT00341809|"     This study will examine the genetic basis of psoriasis and psoriatic arthritis. It is known     that genes play an important role in determining who gets psoriasis or psoriatic arthritis.     This study will look for specific gene variants (alleles) that run in families with these     conditions, or are found more often in people with these conditions than in those without     them.      Participants for this study were identified through the dermatology services of the     University of Michigan Medical Center, the Ann Arbor Veterans Affairs Medical Center, the     University of Kiel, and Henry Ford Hospital. Additional families were provided by the     National Psoriasis Foundation Tissue Bank. They include people with psoriasis or psoriatic     arthritis, or both, in addition to some family members of patients. Only families in which     the age of the patient at disease onset was below 40 years are included. Patients were     included if they had lesions covering more than 1 percent of their total body surface area or     if at least two skin, scalp, nail, or joint lesions were diagnosed as psoriasis. Healthy     volunteers are also enrolled as control subjects.      Participants undergo the following procedures, as follows:      Patients with psoriasis and people without psoriasis who have multiple family members with     the disease        -  Skin evaluation        -  Photographs of lesions for documentation      Patients with psoriatic arthritis and people without psoriatic arthritis who have multiple     family members with the disease        -  Joint evaluation and possibly ultrasound        -  Joint X-rays or review of existing X-rays      Patients with psoriasis only, with psoriatic arthritis, and healthy volunteers        -  Blood draw of 30 milliliters. Some of the blood collected will be used to test for          rheumatoid factor and C-reactive protein in patients with psoriatic arthritis.        -  Periodic questionnaires to update health status information   "
190457|NCT00341887|"     This project, called PHIDISA I, will screen uniformed personnel of the South African National     Defense Force (SANDF) and their registered family members for HIV, hepatitis B and C,     gonorrhea, syphilis, and chlamydia to determine the incidence and prevalence of these     sexually transmitted diseases. It will identify people who may be eligible to participate in     clinical trials for preventing or treating HIV disease and will provide information that will     be helpful in developing policy and better care for people affected with HIV and other     diseases.      This project is part of the South Africa-U.S. PHIDISA Programme-a collaboration between the     South African Military Health Service (SAMHS) of the SANDF, the U.S. Department of Defense,     and the U.S. National Institutes of Health-to help prevent HIV transmission among South     African military and civilian employees and their families.      Uniformed SANDF personnel or their family members who are eligible for health services from     the SAMHS may enroll in the study. Participants visit the clinic every 6 months for up to 5     years for the following tests and procedures:        -  Fill out a demographic information questionnaire        -  Fill out a HIV risk assessment questionnaire        -  Fill out a quality of life questionnaire        -  Blood test        -  Urine test        -  Review of test results and counseling session with a doctor or nurse      Patients who test positive for HIV have a physical examination and additional blood draws.   "
190452|NCT00341822|"     This study will explore the decision-making experiences of women who are currently pregnant     following a period of infertility on whether or not to undergo an invasive prenatal test     (IPT) procedure, such as amniocentesis or chorionic villus sampling. Women who become     pregnant after infertility often experience heightened anxiety regarding the outcome of the     pregnancy. When choosing whether or not to have IPT they are faced with a complex decision,     set in the unique context of a pregnancy that they often perceive as exceptionally     precarious.      Women who are pregnant with their first child after a period of infertility and have made a     decision regarding whether or not to undergo IPT may be eligible for this study.      Participants complete an online password-protected questionnaire that measures infertility     and decision-making variables and explores women's perceptions of the impact of infertility     on their IPT decision-making process. The questionnaire covers the following areas:        -  Subject's demographic information, such as age, marital status, number of children,          education, race, ethnicity        -  Subject's infertility history        -  Subject's thoughts and feelings about infertility        -  Subject's thoughts and concerns about other people's (e.g., husband, doctor, other          infertile women) opinions about IPT        -  Subject's decision about whether or not to have IPT and her feelings regarding the          decision        -  The effect of subject's infertility history on her decision to have or not have IPT   "
190453|NCT00341835|"     This study will search for genes that greatly increase the risk of developing lung cancer in     conjunction with cigarette smoking or other environmental agents, or both. Lung cancer is the     second most common cancer diagnosed among men and women and the leading cause of cancer death     in the United States. It has been frequently given as an example of cancer determined only by     the environment, certain occupations, and dietary habits. Yet researchers have long had a     hypothesis that people vary in their risk of becoming affected when exposed to these factors.     Also, some evidence has shown that lung cancer in families may be due to the combined effects     of inheritance of a major gene and cigarette smoking.      Individuals who have a confirmed diagnosis of lung cancer or a family history of lung cancer     may be eligible to enroll their families in the study.      Family members will be asked to do one or more of the following:        -  Complete a questionnaire about personal medical history, lifestyle, and diet.        -  Have blood drawn from a vein in the arm.        -  If a family member has had a biopsy or is scheduled for one, give permission to obtain          medical records and a portion of the stored tissue.        -  If any relatives have died of cancer, sign a release form to allow researchers to get          copies of medical and pathology records, and tissue samples from surgery.      If the family members agree, they may be recontacted to answer questions about their health     and those of their family, during an annual telephone conversation. Follow-up questionnaires     may be sent to participants, to determine if any new cancers have developed in the family. In     the event of a new cancer, the classification of the family may change from the low-risk to     intermediate risk-level and from the intermediate-risk to high-risk level. Follow-up will     continue, to get information about tumors and death. Also, a newsletter for lung cancer     families will occasionally be distributed to participants. In the future, the Internet will     also provide information for families.   "
190454|NCT00341848|"     Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for     over 200,000 procedures each year. Most epidemiologic studies of uterine leiomyoma show that     parity has a protective association with leiomyoma, but the mechanism is not known. Both     epidemiologic data and data from an animal model indicate that the protective association is     not an artifact resulting from reduced fertility among women with fibroids. We hypothesize     that the process of uterine regression following delivery results in loss of small fibroids     due to selective apoptosis of transformed cells and the extensive remodeling of the entire     uterus.   "
190455|NCT00341861|"     The incidence rate of bladder cancer in the Barcelona area of Spain is almost identical to     that of the U.S. Cigarette smoking has been identified as the most significant risk factor     for bladder cancer, followed by occupational exposures to chemicals such as aromatic amines     and their derivatives, diesel exhaust, oil mist, pesticides, and polynuclear aromatic     hydrocarbons. A variety of non-occupational exposures have been suggested as potential risk     factors as well, including smoking black vs. blond tobacco, dietary factors, certain     medications and medical conditions, chlorination by-products in drinking water, and fluid     intake. Various genetic polymorphisms also appear to affect bladder cancer risk. Research is     needed to further explore hypotheses generated by previous etiologic studies of bladder     cancer. An on-going study of bladder cancer survival by the Institut Municipal d'Investigacio     Medica in Spain provides an excellent opportunity for NCI to perform such research. NCI will     build upon the ongoing study by funding an interdisciplinary case-control component to     evaluate bladder cancer risk in relation to various external factors (e.g., occupational and     environmental exposure) and host factors (e.g., genetic susceptibility markers, and early     effect markers). This hospital-based case-control study will involve personal interviews     using a state-of-the-art, computer assisted technique, and collection of blood and toenail     samples from participants.   "
190456|NCT00341874|"     The incidence of hearing impairment in India and Pakistan is higher than in the United     States. This can be attributed to several factors, including infection and high rate of     inbreeding which may result in homozygosity for a rare recessive mutation. The average family     size is larger in India and Pakistan when compared to the United States. In addition, there     are more than 1 billion people in India while the population size of Pakistan is     approximately 148 million. The ability to detect linkage is greatly enhanced in an extended     inbred family. It is estimated that as many as 45% - 60% of marriages in Pakistan are between     close relatives (the vast majority of marriages are to first cousins). While the percentage     of consanguineous marriages are not as high in India as compared to Pakistan, the population     size of India is much larger.      Hearing impairment is the result of abnormal ear development, abnormal ear function or both     and yet little is known about the molecular mechanisms involved in the development and     homeostasis of the inner ear. Although the genes for several recessive deafness loci have     been identified, there are still many families segregating deafness that cannot be ascribed     to one of the currently known genes. The purpose of this study is to continue to identify     genes that cause nonsyndromic hereditary hearing impairment by enrolling families segregating     deafness.   "
190579|NCT00343655|"     The purpose of the study is to evaluate the effect of 18 months treatment with atorvastatin     80mg or atorvastatin 10mg on the carotid vessel plaque morphology, in particular, the effect     on evident necrotic lipid rich core of the plaque in patients.   "
190580|NCT00343668|"     The primary goal of this phase II trial is to evaluate the response rate of combination     chemotherapy with S-1 and Irinotecan in patients with advanced gastric cancer as a first-line     therapy.   "
190600|NCT00343980|"     This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to     compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding     rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety     (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)   "
190458|NCT00341900|"     Ionizing radiation efficiently induces chromosomal aberrations (CA) and several studies of CA     have now been conducted among small groups of flight crews. However, most of the studies only     evaluated the unstable aberrations that reflect recent exposures, but not long-term     cumulative cosmic radiation exposure. Chromosome painting by fluorescence in situ     hybridization (FISH) is a widely used and established cytogenetic method for detecting stable     aberrations such as translocations. Thus, FISH can be used for estimating chromosomal damage     from cumulative radiation exposure. No large studies of flight crews utilizing FISH have been     conducted to date.      We propose a study to measure CA using FISH in a group of pilots estimated to have high comic     radiation exposure based on flight histories, i.e., those with long duration flying     international routes, and a comparison group of university faculty with minimal flying     history. These measurements will be used to determine if pilots have elevated frequencies of     CA (specifically stable translocations) as compared with the university faculty. In addition,     the frequencies of CA will be examined in relation to the cumulative cosmic radiation dose to     determine if there is a dose-response relationship. Individual cumulative doses will be     calculated from pilot flight histories using a computer program developed by the FAA which     estimates cosmic radiation does by accounting for changes in altitude and latitude, and the     11-year solar cycle at the time of the flight. We will collect information on age, lifestyle     factors, diet, health history, family cancer history, and medical radiation exposures from     personal interview and self-administered dietary questionaire. These factors may affect the     CA frequency and so we plan to adjust for them in the statistical analyses.      Pilots will be identified based on the Allied Pilots Association roster and faculty from a     commercial company that maintains a database of university faculty, including those in the     Chicago area. Potential participants will be notified of the study by mail and     recruited/screened for eligibility over the telephone. We will compensate participants $100     for their time. A field station will be set up at a medical or health clinic convenient to     the participants, where interviews Will be conducted and a peripheral blood sample collected.     Participants will be notified of the overall study results and may request their personal CA     results at the end of the study. Participants may also choose to have additional blood drawn,     however this blood sample will be anonymized so that it cannot be linked back to the     participant. Genotypic variants in DNA repair (and possibly other) genes will be evaluated     for an effect on CA frequency.   "
190459|NCT00341913|"     Reduced susceptibility of Staphyloccus aureus to the glycopeptide antibiotic vancomycin is     causing increasing concern worldwide in view of the threat of increased morbidity and     mortality caused by such resistant organisms. MRL Pharmaceutical Services, a Division of     Focus/MRL, has been contracted by NIAID to establish a Network on Antimicrobial Resistance in     S. aureus (NARSA) to document cases where staphylococcal isolates with reduced susceptibility     to vancomycin (MIC's greater than or equal to 4 micrograms/ml) have arisen and to procure     such isolates into a central repository for distribution to registered approved researchers.      MRL will be responsible for contacting sites where such isolates have been reported to     discuss the test methods used to determine the reduced vancomycin susceptibility status of     the isolate. Once the MRL Laboratory has determined that the isolate meets the criteria     stated above, the site will be asked to ship the isolate to MRL as a possible candidate for     inclusion in the NARSA Repository. The procurement strategy will involve issuing each isolate     a temporary strain designation number which will be destroyed once the antibiotic profile of     the isolate has been confirmed at MRL, thus preventing any link to the data generated by the     site. The isolate and its antimicrobial susceptibility profile to several key drugs will be     recorded in the NARSA Repository database. Demographic information related to the isolate and     collected from the site includes: The Name of the Donor Site/Institution, City (to be held in     a separate secured database, these data points are not available to registered user); State,     Country of Donor Site; Isolation Date; Age; Sex; Patient Location; Patient Service; Culture     Source; Reporting History. This information will be held in the Registry database. Since     patient-specific information will not be collected, a request for a waiver of informed     consent has been requested herein.      NIAID funded investigators (NARSA Core Investigators) and other approved registered users     whose research focuses on S. aureus will have access to the Registry/Repository database and     will be able to request isolates for use in their research. Facility specific information     will be held in a separate secured database that is not available to registered researchers     unless approved through an IRB review.   "
190460|NCT00341939|"     This study is a retrospective one, exploring the hypothesis that a person's genotypic makeup     may be associated with a clinical response or toxic effect to a drug. Genetic polymorphisms,     that is, states of being able to assume different forms, that are in drug-metabolizing     enzymes, transporters, and receptors may affect a patient's response to drug therapy. To     date, there have been limited studies looking at a drug-metabolizing genotype (genetic     makeup) or phenotype (result of the genotype's interaction with the environment). However, it     is often wondered if the variations in a drug's action, that is, pharmacokinetic effect, come     from the genotype phenotype relationship.      Participants who entered previous clinical trials at the National Cancer Institute, as     approved by the Central Institutional Review Board, may be eligible for this study. Studies     for which pharmacokinetic analyses were or are being performed will be the source of the     patient population.      Genotyping experiments will be performed through genomic DNA isolated from stored frozen     serum. The genotyping results will be compared with pharmacokinetic data and clinical     outcomes. Clinical data will consist of what is obtained during the course of the principal     pharmacokinetic study. The results of the retrospective analyses will provide no direct     benefit to the participants.   "
190470|NCT00342082|"     This collaborative investigation between NIEHS, Duke University, and the University of North     Carolina (UNC) will study red blood cells of babies born to HIV-infected women receiving     anti-retroviral treatment. Studies have shown that newborn mice whose mothers were given     anti-HIV medications during pregnancy had abnormal red blood cells circulating in their blood     stream, indicating genetic damage to the cells caused by the anti-HIV medications. It is not     known if similar red blood cell abnormalities develop in human infants whose mothers received     anti-HIV medication during their pregnancy. This study will examine red blood cells from     infants exposed to anti-HIV medications and from non-exposed infants to look for differences     between them involving this specific genetic damage.      Healthy pregnant women and HIV-infected pregnant women who received antiretroviral treatment     during their last trimester of pregnancy and during labor may be eligible for this study.     Babies of HIV-infected women are also included in the study. Candidates will be recruited     from medical centers at Duke University and the UNC. HIV-infected mothers must plan to have     their baby followed by either the UNC or the Duke Pediatric Infectious Disease clinic.      All women in the study will have 1 milliliter (less than 1/2 teaspoon) of blood collected for     this study during delivery at the same time that other blood samples are obtained for their     medical care. In addition, 5 ml (1 teaspoon) of umbilical cord blood will also be collected     for this study at the time of delivery after the cord is no longer attached to the baby. This     concludes participation of non-HIV infected women.      Babies born to HIV-infected mothers will have 1 ml of blood drawn between 0 to 3 days of     life, between 4 to 6 weeks of life, and between 4 to 6 months of life. These bloodsamples     will be collected at the same time as other routine scheduled blood draws.   "
190461|NCT00341952|"     Non-Hodgkin's lymphoma (NHL) incidence rates have risen three percent per year in the U.S.     for four decades. Mortality from NHL has risen 1.6 percent, compared with 0.2 percent for all     cancers combined. This epidemic curve appears in both sexes and around the world, suggesting     the possibility of an etiologic agent increasing in prevalence in the general environment.     Recent research has identified several possible candidates including pesticides, other     organochlorines, drinking water nitrates, and sunlight. There is an urgent need to evaluate     whether these common exposures are contributing to the rapid rise in NHL, and to investigate     other hypothesized risk factors such as viruses, medical conditions, hair dye use, and     genetic factors. The purpose of this study is to examine the contribution to NHL risk of     these important environmental, occupational, viral, medical, and personal exposures, and to     pursue important leads emerging from on-going NHL research. This multidisciplinary,     population-based case-control study will involve personal interviews to collect information     on demographics, residential history, pesticide use, and occupational exposures;     self-administered questionnaires to collect information on diet, family and medical history,     and other exposures; tap water and carpet dust sampling to collect information on nitrate and     pesticide exposures; and blood sampling for measurements of compounds in the serum,     antibodies to viruses, and examination of genetic polymorphisms.   "
190696|NCT00344578|"     To evaluate the clinical outcomes of AcrySof® ReSTOR® IOL for the Faculty Practice at UTSW     Medical Center at Dallas   "
190462|NCT00341965|"     We propose to conduct a study to increase our understanding of farming practices and of the     potential for previous exposure to DDT in North Carolina African American male agricultural     workers, a group especially likely to have had high DDT exposure. Because of potentially     widespread DDT exposure from agricultural activities, African American farmers and farm     workers may be uniquely at risk for any associated health effects. However, little is known     about levels of pesticide exposure in African American farming populations. Three hundred and     eighty-nine African American men who are current or former farmers or farm workers will be     asked to participate in the study. These men are members of the Supplemental Minority Cohort     of the NCI/NIEHS/EPA Agricultural Health Study (AHS). The AHS is a prospective study of the     potential health effects associated with agricultural exposures. Men in the supplemental     cohort were recruited in 1996. At that time, they completed an enrollment questionnaire that     focused on lifetime agricultural exposures, demographics, lifestyle factors and health. In     this new study, a follow-up questionnaire will be administered by telephone by a trained     interviewer to all men. Following the interview, the participant will be asked to donate a     blood specimen, to have anthropometric indices (e.g., height, weight, waist and hip     circumference, etc.) measured, and to have a top- and side view Polaroid photograph of their     head taken during one visit to a central community location, such as the local church or     health clinic. We will quantitatively document serum p,p'-DDE levels, correlate these with     self-reported farming activities and DDT exposure, and describe the health status of these     men. We will also correlate serum p,p'-DDE levels and androgen concentrations, since p,p'-DDE     is thought to be a potent androgen receptor antagonist. This exploration of the potential     link between levels is important because the demonstration of any subclinical physiological     effects of p,p'-DDE would increase the plausibility of a wide range of health effects that     have been postulated to be associated with the endogenous endocrine environment and the     so-called endocrine disrupters. In addition, we will evaluate the relationship between     several important physiological parameters which can be easily and accurately measured in     serum, and physical characteristics including hair patterning and distribution of body fat in     these African American men.   "
190463|NCT00341991|"     This case-control study was planned to investigate the link of solar radiation with gene     damage, host factors, and DNA repair proficiency in cutaneous malignant melanoma (CMM) risk.     The hypothesis was that impaired DNA repair proficiency is associated with an increased risk     of CMM due to unrepaired DNA damage, particularly in subjects with dysplastic nevi, poor     tanning ability or genetic susceptibility.      The study was reviewed as an RO1 Grant from the National Cancer Institute in 1995. Subject     enrollment, which included clinical evaluation, epidemiologic questionnaires, and skin and     blood sample collection, was completed in 1999 on approximately 180 melanoma cases and 180     controls identified in Italy. The study protocol and consent form both included the     measurement of genetic and biochemical factors and DNA repair capacity. DNA repair     proficiency was measured in lymphocytes by the host cell reactivation assay, and sun exposure     was evaluated by means of a detailed questionaire. Photographs of the back of the subjects     were taken to allow nevi count. Minimal erythemal dosage was measured in all subjects to     estimate skin sun sensitivity 24 hours after skin's UV-irradiation. Skin color was     ascertained on the inner side of the forearm by means of a Minolta chromometer.      The aim of this protocol is to continue analysis of the biological samples already collected,     as originally outlined in the study protocol. In particular, we plan to measure polymorphisms     in genes that may lead to susceptibility to melanoma. Initially we will concentrate on     variation in genes involved in repairing damaged DNA, but plan to look at a broad group of     candidate susceptibility genes.   "
190464|NCT00342004|"     A prospective cohort study is proposed to evaluate occupational and environmental risk     factors for cancer among women in Shanghai, China. Approximately 75,000 women aged 40-69 who     reside in eight geographically defined communities in two urban districts of Shanghai will be     recruited via a community-based cancer education program. All eligible subjects will be     invited by local health workers from the neighborhood health station to the clinic for an     interview and selected anthropometric measurements. The interview will elicit information on     demographic background, diet, lifestyle factors, medical history, lifetime occupational     history and residential history for the past 20 years. In addition, the women will be asked     for information on their husbands' current and usual occupations, and demographic and a few     other exposure factors. A spot urine sample and 10 ml of blood will be collected from all     cohort members and stored at -70 degrees C for future assays of urine metabolites and DNA and     hemoglobin adducts of selected occupational and environmental carcinogens, and polymorphic     genes encoding enzymes that are involved in metabolism of relevant carcinogens. Cohort     members and their husbands will be followed for cancer outcomes through biennial recontact     and linkage with files of the population-based Shanghai Cancer Registry, of the Shanghai     Vital Statistics, and of the Shanghai Resident Registry. Medical records and pathology slides     will be reviewed for all cancer cases to verify their diagnosis. Post-diagnostic blood     samples will be obtained from all cohort members diagnosed with cancer during the follow-up     period and stored for future methodologic and etiologic studies. The proposed initial study     period is 5 years, with an average follow-up of about 3.5 years. We anticipate, however, that     follow-up will continue for 10 years or more.   "
190483|NCT00342264|"     Diesel exhaust has been classified as a probable carcinogen by the International Agency for     Research on Cancer and as a potential carcinogen by the National Institute for Occupational     Safety and Health (NIOSH). The carcinogenicity of this pollutant is of concern not only for     the one million workers who are exposed occupationally, but also for the general population.     Over 30 epidemiologic studies of diesel exhaust exposure have been performed, and the results     suggest an increase in lung cancer risk. However, the association is not well defined. Past     studies have suffered from the use of crude indicators of exposure, inadequate control of     confounding, and/or short follow-up periods, low exposure levels, and small numbers of     observations.      NCI and NIOSH are collaborating on two related studies of diesel exhaust under the NCI/NIOSH     Interagency Agreement. First, a retrospective cohort mortality study of about 8,200 non-metal     miners will be performed to investigate lung cancer mortality in relation to quantitative     measures of diesel exhaust exposure, and to determine whether there is evidence of elevated     mortality from other causes of death among diesel exhaust exposed miners. The retrospective     cohort study will be performed using existing records and information and has been exempted     from IRB review. NIOSH is the lead agency on the retrospective cohort study.      The proposed study is a case-control study nested in the retrospective cohort of non-metal     miners. The study is expected to include at least 160 members of the cohort who died from     lung cancer and four matched controls for each case. Using a structured questionnaire,     detailed information will be collected on each subject's lifetime exposure to diesel exhaust,     as well as information on smoking and other confounders. This information will allow     investigators to examine the association between lung cancer and different quantitative     measures of diesel exhaust exposure, adjusted for smoking and other potential confounders.   "
190465|NCT00342017|"     This study, sponsored by the National Institutes of Health and the Tuberculosis Research     Centre in Chennai, India, will examine how helminth and filarial infections affect the immune     response to mycobacteria (the bacteria that causes tuberculosis). Helminths are parasitic     worms that infect the gut, and filaria are worms that circulate in the blood and infect     various tissues. The findings of this study may affect how tuberculosis is assessed in     Chennai, where filarial and helminth infections are common in the population.      Patients between 6 and 65 years of age with helminth or filarial infections who do not have     active tuberculosis, cancer, AIDS, or other immunosuppressive illness may be eligible for     this study. Participants will be recruited from villages in the Chingleput District of     Chennai, India.      Participants will complete a medical history and physical examination. They will have a blood     test to determine red blood cell count and to detect filarial infection, a stool examination     to detect helminth infection, and a tuberculin skin test for tuberculosis. Patients with a     positive tuberculin test will be treated for tuberculosis and any filarial or helminth     infections that may have been detected.      Patients whose tuberculin test is negative will be invited to participate in the second part     of the study-to determine whether people with either filarial infections or helminth     infections, or both, respond to tuberculosis bacteria in the same way as people who do not     have these infections. Participants will undergo a review of their medical history, a     physical examination, and a blood test to assess red blood cell levels and to look for     evidence of filarial or helminth infection. They will then be randomly assigned to receive     either albendazole and DEC (anti-helminth and anti-filarial drugs) or a placebo (look-alike     tablets that do not contain an active ingredient). Two months later, patients will receive a     second dose of the same tablets (placebo or active drug) they took previously, and after     another 4 weeks they will be re-tested for tuberculosis. After 6 months (at the end of the     study) all participants will receive anti-helminth and anti-filarial drugs and will have a     repeat tuberculin skin test. Blood and stool samples will be collected twice in the 6-month     period after the initial treatment to determine the levels of antibody against the parasites,     to measure the level of infection with filaria, and to measure the level of red blood cells.   "
190466|NCT00342030|"     There is suggestive evidence for a role of dietary in the etiology of asthma and chronic     bronchitis. However, there are few prospective data. We propose to expand our collaboration     with the Singapore Chinese Health Study to examine dietary, environmental, and genetic     factors, along with their interactions, in relation to the risk of developing asthma and     chronic bronchitis. The Singapore Chinese Health Study is a cohort of 63,257 men and women of     Chinese ethnicity in Singapore who were aged 45-74 years at enrollment from 1993 to 1998.     Telephone follow-up of the cohort to update and outcome information began in 1999 and is     ongoing. We expect to identify 538 cases of incident asthma and 672 cases of incident chronic     bronchitis when the current follow-up questionnaire cycle is complete in 2004. In this     proposal, we would validate self-reports of incident asthma, obtain follow-up data from the     entire cohort to perform analyses of dietary and smoking in relation to these outcomes, and     analyze genetic material on cases of incident asthma and chronic bronchitis and controls from     the cohort. In this proposal we will examine the following hypotheses:        1. Higher intake of fruits and/or antioxidant micronutrients decreases the risk of          developing asthma and chronic bronchitis.           a. Effects if fruit and/or antioxidant micronutrients may differ by smoking history.        2. Common polymorphisms in genes involved in the response to oxidative stress influence the          risk of asthma and chronic Bronchitis. We initially propose to examine polymorphisms in          three genes--glutathione S-tranferase M1, glutahione S-transferase P1, and matrix          metalloproteinase-1. However, we plan to examine additional relevant polymorphisms in          the future, especially taking advantage of high throughput screens of candidate genes          for asthma and chronic bronchitis. It is possible that by 2004 when the sample set will          be available that more compelling candidates and high throughput screens may be          available to us at a low cost. Thus we will re-evaluate our choice when the samples are          available.        3. Polymorphisms in these and other genes interact with fruit/antioxidant intake and/or          smoking to influence the risk of asthma and chronic bronchitis.   "
190467|NCT00342043|"     This study, sponsored by the National Institutes of Health and the University of Bamako in     Mali, Africa, will examine factors that may protect against progression of malaria from mild     to severe disease. Infection with the malaria parasite causes disease ranging in severity     from mild or no symptoms to severe. A better understanding of what factors protect against     disease progression may help scientists develop improved methods of disease prevention and     treatment. The objectives of this study are to:        -  Identify differences in protective factors for severe malaria in Malinke children          residing in two Mali villages, Kela and Kangaba. Genetic variations in hemoglobin          proteins called HbS and HbC appear to confer protection against severe disease in some          children but not others. HbC appears to protect young Malinke children living in Kela,          but not in nearby Kangaba, while HbS protects children in Kangaba but not in Kela. In          addition, deficiency of an enzyme produced by red blood cells called G6PD protects          males, but not females, from severe malaria.        -  Investigate how fetal hemoglobin (HbF) may protect against malaria in infants and          determine how HbS, HbC, G6PD deficiency, and beta-thalassemia trait affect the rate of          HbF decline during the first 2 years of life.      Children under 11 years of age who seek medical care at Kangaba or Kela health centers for     symptoms of malaria may be eligible for this study. Each will be screened with a medical     history, physical examination and blood test. In addition, healthy infants born to women     referred to field site clinics may be enrolled for the newborn study. Participants undergo     the following procedures:      Children with mild malaria are treated with artesunate and amodiaquine. Those with severe     malaria are treated with quinine. Blood is collected by finger prick every day for 4 days to     evaluate the response to treatment and for genetic testing. Some blood is stored for future     research related to malaria.      Newborns have a heel or finger prick at 1, 3 and 6 months to collect a small blood sample for     genetic testing. In addition, at the time of birth, a small amount of blood is collected from     one of the blood vessels of the placenta. Some infants may be followed up to 2 years, with     additional drops of blood taken at 12, 18 and 24 months. Some of the blood is stored for     future research related to malaria.   "
190468|NCT00342056|"     This study will examine DNA from cancer patients previously treated with Gleevec to look for     a variation (mutation) of the ABCG2 gene that may render the drug less effective in certain     patients. Gleevec is used to treat chronic myeloid leukemia and gastrointestinal tumors.     Although most patients respond to treatment, many with advanced disease develop resistance to     the drug. It is thought that in some patients this resistance results from the action of a     protein that causes Gleevec to be pumped out of the cells, reducing its usefulness.      Patients enrolled in clinical trials of Gleevec at the National Cancer Institute and at other     participating institutions are eligible for this study.      DNA from patients' blood samples are analyzed for the ABCG2 gene and correlated with clinical     data, such as the patient's age, race, disease state, weight, height, and body surface area.     It will also look at the drug dose, how often the drug is given, the duration of treatment,     side effects and other medications taken.   "
190469|NCT00342069|"     This study will examine how women think and feel about prenatal testing (amniocentesis and     chorionic villus sampling), how those thoughts and feelings change over time, and how they     contribute to the decision whether or not to undergo prenatal testing.      Prenatal diagnostic testing is offered to pregnant women at increased risk of carrying a baby     affected with a genetic or chromosomal abnormality. Although these tests are well     established, standard-of-care procedures, much remains unknown about how best to ensure that     women make decisions about whether or not to undergo testing that are consistent with their     beliefs and values. This study will explore the extent to which women are ambivalent about     prenatal testing and determine how they might benefit from counseling aimed at improving the     quality of their decision-making.      Women 18 years of age and older who are scheduled for a prenatal genetics visit at clinics in     Baltimore, MD; Minneapolis, MN; Binghamton, NY; Salt Lake City, UT; Washington, DC; and     Bellevue, WA, and are at increased risk for having a baby with trisomy 21 (Down syndrome) may     be eligible for this study.      Participants complete two short questionnaires and a telephone interview about their thoughts     and feelings regarding prenatal testing. The first two surveys examine the women's thoughts     and feelings before and after prenatal counseling. Both are completed at the prenatal     clinic-one before and one after the counseling session. The third survey is done by telephone     a few weeks after the prenatal visit to find out if the participant did or did not have     prenatal testing and learn about her thoughts and feelings regarding her decision.   "
190582|NCT00343707|"     This six-arm study is being conducted to measure the effect of a combination of paroxetine     and vestipitant on the arousal induced by public speaking in Seasonal Effective Disorder     (SAD) patients, using functional brain imaging readouts (i.e., WAT(Wave Analysis Technology)     PET(Positron Emission Tomography)), after one or eight weeks of treatment. The effect of     paroxetine alone after one or eight weeks of treatment will also be measured.   "
190502|NCT00342537|"     This study is a collaboration between the Clinical Genetics Branch of the National Cancer     Institute and the International Testicular Cancer Linkage Consortium (ITCLC). The primary     goal of the ITCLC is mapping and cloning susceptibility genes for familial TGCT. The     objectives of the current study are to:        -  Identify the genes responsible for testicular germ cell tumor (TGCT) (testicular cancer)          in families with an inherited tendency to develop the disease        -  Determine if the genes which predispose to developing testicular cancer also increase          the risk of other specific types of cancer among first- and second-degree relatives of          patients with TGCT        -  Determine if the microscopic appearance of familial testicular cancers is different from          that of non-familial TGCT      Patients and family members recruited by the ITCLC in the United Kingdom, the Netherlands,     and Norway are eligible for this study. Individuals with the following medical criteria may     participate:        -  Patients with testicular germ cell cancer who have at least one other blood relative          with the disease        -  Family members of patients (first- and second-degree relatives)      Participants undergo the following procedures:        -  Fill out questionnaires for providing information about a history of cancer in all blood          relatives, including parents, siblings, children, grandparents, aunts, uncles, and          cousins, and a history of undescended testes in male blood relatives. Participants may          be asked permission to contact family members to request their help in the study as          well.        -  Provide a blood sample for genetic testing related to TGCT (except in children under 16          years old).        -  Review of medical records and examination of tumor specimen (patients with TGCT only).        -  Confirmation of the diagnosis of other types of cancer in these same families (medical          records, pathology repots)        -  Review of the testicular cancer tissue obtained at the time of surgery from members of          multiple case families, and comparison of these findings with a series of TGCT which          have developed in men without a family history.   "
190471|NCT00342095|"     Systemic lupus erythematosus (SLE) is severe, chronic, disabling autoimmune disease that     significantly affects health status and quality of life. Since the disease occurs most often     in young to middle-aged adults, SLE can also affect work and disability. However, there is     currently little information on work-related disability from longitudinal, population-based     studies of SLE.      Participants were enrolled into the Carolina Lupus Study between February, 1997 and July     1999. We plan to conduct two telephone contacts with patients and one telephone contact with     controls in a follow-up study to be conducted in 2001. The first patient contact will follow     an introductory letter that describes the follow-up study. This letter provides participants     the opportunity (via a toll-free phone number) to decline further contact about this study.     The first patient contact will be a short (5 minute) interview in which we determine their     current source of lupus-related medical care, timing of next expected visit, and update     contact information. The second contact will involve a 60-minute telephone interview covering     medical care utilization, current health status (including a patient-administered measure of     lupus activity), work and disability issues, psychosocial attributes (e.g. helplessness,     social support, daily stressors including race-related issues), and changes in exposures     since the initial interview. We will attempt to schedule the patients' interviews within 3     months before or after the patient sees his or her own physician for SLE-related evaluation     or treatment. A short (15 minutes or less) telephone interview will be conducted with     controls focusing on current health, work status, and daily stresso.      Ddisease damage will be assessed using the System Lupus international Collaborating Clinics     (SLICC)/American College of Rheumatology (ACR) Damage Index, a standardized and validated     instrument that is completed by the patient's physician.      We will seek death certificates for patients and controls who have died in order to obtain     cause of death information. Next-of-kin information from death certificates will not be used.      This study will allow up to determine the feasibility of obtaining reliable data on disease     damage from more than 50 physicians involved in the treatment of patients in the Carolina     Lupus Study. This developmental work is a necessary foundation for any additional follow-up     studies of the Carolina Lupus Study cohort. We will also be able to examine associations with     disability in patients and in controls and to examine the contribution of various factors to     the increased disease severity experience by African-American SLE patients.   "
190472|NCT00342108|"     This study will investigate the effect of enhanced visual and cross-modal environments upon     the visual attentiveness of multiply handicapped children diagnosed with Cerebral Palsy (CP)     and Cortical Visual Impairment (CVI).      Research Hypothesis        1. Adapted visual environments which present controlled auditory, tactile, proprioceptive          or contrasting visual background stimulation will enhance the visual attentiveness to a          given visual stimulus of children diagnosed with CP and CVI.        2. Systematic, repetitive, visual stimulation over time, improves the visual attentiveness          and/or visual-motor responses of CP-CVI children.        3. The analysis of additional behavioral responses to visual stimuli is a critical          component in evaluating the perceptual development of visual attention in CP-CVI          children.      Use of Noldus: The Observer, an advanced objective computerized observation program, will     enable precise detection of the neurobehavioral responses of the participants. Both overt and     covert responses will be observed, analyzed and correlated to identify the level of attention     of each participant.   "
190473|NCT00342121|"     This study will look for links between corn farming practices and short-term changes in     immune function in farmers throughout the growing season. It will examine biologic effects     associated with specific pesticide exposures and general planting activities, such as     tillage. Farmers have an increased risk of non-Hodgkin s lymphoma and certain other blood     cancers such as multiple myeloma and leukemia, but the reasons for this increase have not     been identified. Findings of this study may contribute to learning the causes of cancers such     as non-Hodgkin s lymphoma.      Farmers enrolled in the Agricultural Health Study (a study of pesticide applicators and their     spouses in Iowa and North Carolina) and a group of control subjects selected from     agricultural extension workers in Iowa may participate in this study.      The study involves six home visits to farmers and four visits to farmers to individuals in     the control group. All participants will complete the following tests and procedures:        -  Questionnaires and diaries During the first visit, all participants will have a medical          history review, including questions about smoking and other health habits. Farmers will          be asked about their farming practices, and controls will be asked about their          occupations. Farmers will fill out daily diaries during short time periods of interest          around certain pesticide applications to describe farming activities that day. At other          times during the growing season before harvest, farmers will fill out weekly diaries          describing farming activities; controls, meanwhile, will fill out weekly diaries          describing their health and work activities. At home visits during the farmers growing          season, all participants will fill out questionnaires about their health. Finally,          farmers and controls will complete a more extensive questionnaire in the off-season,          during the last home visit, to learn about their activities and exposures in the final          part of the year (post-harvest for farmers).        -  Urine samples: At the time of each home visit, controls will provide a urine sample that          the interviewer will take that day. Farmers, too, will provide urine samples at the time          of home visits, but they will also collect urine samples for a period of 4 days each          during short time periods of interest after certain pesticide applications. The          interviewer will collect these samples immediately at the end of these periods.        -  Blood samples: At the time of each home visit, the interviewer will draw 50 ml (3.5          tablespoons) of blood.        -  Telephone calls: Farmers will be called frequently from once every 2 weeks to every          other day to schedule visits at the times of interest. Control subjects will also be          called frequently to schedule their visits closely to those of the farmers.   "
190474|NCT00342134|"     Our goal is the elucidation of the mechanisms of action of autologous hematopoietic stem cell     transplant (HSCT) and immunoablation by high-dose cyclophosphamide in multiple sclerosis     (MS).      The molecular pathogenesis of multiple sclerosis is poorly understood although T-cell     mediated immune destruction of myelin is thought to be an important element. We hypothesize,     and the results of previous studies suggest, that radical immuno-ablation characterized by a     profound T cell depletion can arrest the progression of disease. Patients with MS with poor     prognosis based on the rate of progression and refractoriness to approved treatments     (interferon-beta, glatiramer acetate) will be enrolled in clinical trials at the     collaborating institution (NWU-Dr. R. Burt; Dr. D Kerr, JHU) and will receive either immune     ablation with cyclophosphamide and the antibody Campath-1 followed by reconstitution with     autologous peripheral blood stem cells, a procedure similar to autologous bone marrow     transplantation, or high-dose cyclophosphamide treatment without stem cell rescue. While the     overall treatment-related mortality worldwide is approximately 10%, the collaborating     institution and investigators have an outstanding safety record in performing the procedure     with no fatal adverse events after having transplanted more than 30 transplants with a     previously more aggressive regimen than the one that is in use now. The underlying rationale     for this treatment is that immuno-ablation could eliminate myelin-reactive T cells which, in     disease-susceptible individuals, may have been activated by previous exposure to     environmental agents or other acquired mechanisms of immune dysregulation.      In the proposed study we plan to address whether HSCT or immunoablation without stem cell     rescue act beneficially in MS via the eradication of myelin-reactive T cells and     reconstitution of a functional and non-autoimmune immune repertoire. To achieve this goal, we     will compare peripheral blood T cell reactivities to myelin antigens before and after the     treatment in 34 patients with MS. In parallel, to identify potential disease-mediating cells     that do not recognize these myelin antigens, we will search for clonally expanded cells in     the blood of MS patients before treatment employing molecular analysis of T cell receptor     repertoire. Expanded T cell clones will be tracked during post-transplant follow-up of     patients. If the eradication of certain clonotypes resulting from immuno-ablation correlates     with disease remission, we will attempt to isolate these cells in culture from pre-treatment     samples and determine their specificity using combinatorial peptide libraries. We would use     the same approach in case of reappearance or new clonal expansions concomitant to disease     relapses. We will combine these studies with a broader, unbiased approach that employs     microarray technology to identify potential changes in gene expression profiles. This     approach may also lead to the identification of novel therapeutic targets for pharmacological     treatment.   "
190475|NCT00342147|"     Nasopharyngeal carcinoma is a rare tumor among Caucasians which occurs with high incidence     among individuals of Chinese descent. The disease is believed to have a multifactorial     etiology with genetic, viral, and other environmental factors being involved. Little is     known, however, about the genetic component of this disease.      We have recently completed subject recruitment for a case-control study of NPC in Taiwan.     Using information obtained from the NPC cases recruited into this NCI-sponsored case-control     study as well as from a parallel cross-sectional study conducted by our Taiwanese     collaborators, we have been able to identify 120-150 families with multiple family members     affected with NPC.      The purpose of the study described herein is to determine the role of inherited genetic     factors in the etiology of NPC and to examine the effect of these genetic susceptibility     factors on risk associated with environmental exposures.      Families will initially be contacted via the proband who previously participated in our     case-control and cross-sectional studies. Subsequently, informative family members will be     asked to visit the study clinic to participate in the study. A family history questionnaire     will be administered to the proband from each of the families selected for study. In     addition, a risk factor questionnaire will be administered to all participating family     members, and 30-40 ml of blood and an oral sample will be obtained from each study     participant. Additional study components include medical record review to verify the     diagnosis of NPC, retrieval of tumor tissue blocks as a source of DNA for study, and clinical     exams on a sample of unaffected individuals to exclude the possibility of prevalent,     undetected disease among family members.      Oral and laryngeal cancer families will also be recruited in a manner similar to that     described for NPC families, in an attempt to elucidate genetic factors linked to the     development of these two cancers.   "
190476|NCT00342160|"     This study will look at viral and immunologic factors involved in protecting against sexually     transmitted HIV infection in couples in which one partner is infected and the other is not.      This study will include 50 couples who reside in Rakai, Uganda, and who have been together     for at least 2 years. In some couples, both partners will be HIV-infected, in some couples     only one partner will have HIV, and in some couples neither partner will have HIV.      Participants undergo the following procedures at each of four study visits:        -  HIV counseling and testing        -  Medical history, including questions about personal behaviors such as sexual practices          and use of condoms        -  Blood sample collection        -  Urine sample collection        -  Vaginal swab for women      Blood, urine and vaginal fluid samples are tested for HIV and other sexually transmitted     diseases, such as syphilis. Blood and vaginal samples are also tested for HIV viral levels     and immune response in HIV-infected individuals and for evidence of exposure to HIV in     non-infected participants. Some blood is also tested for genetic markers to investigate     whether certain proteins are related to resistance to HIV infection.   "
190601|NCT00343993|"     with appropriate inspired oxygen concentrations, NPPV would prevent intubation and hence     avert the poor outcome associated with the need of invasive ventilation in patients with     ALI/ARDS.   "
190477|NCT00342173|"     A population-based study was initiated in Costa Rica in June 1993 to investigate the natural     history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months,     ending in December 1994, 10,080 women were recruited into our study, after informed consent     was obtained. At the initial recruitment visit, all women were administered a brief risk     factor questionnaire, had 15ml of blood collected and, if sexually active, were given a     pelvic examination. At the time of the pelvic examination, a Pap smear was collected, as were     additional cervical cells which were then used for additional monolayer smears (ThinPrep) and     for human papillomavirus and other testing. Pictures of the cervix, known as cervigrams, were     also taken as a third screening test. Based on these screening tests, women were referred to     colposcopy, at which time a more detailed risk factor questionnaire was administered,     additional cervical cells and blood (15ml) were collected, and histological specimens were     obtained, if indicated by the colposcopy. Women diagnosed with a high-grade cervical lesion     (HSIL) or cervical cancer were treated by Social Security Administration clinicians using     standard local protocols.      Women without evidence of HSIL or cancer at enrollment comprise the group of subjects who     have been followed as part of our longitudinal study. Three distinct groups of women of     approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The     first group consists of women who at enrollment had evidence of low-grade cervical lesions     (LSIL) or equivocal lesions and a sample of the remaining cohort members. This group is being     followed actively at 6-12 month intervals through their seventh anniversary in the cohort.     The second group consists of women who were cytologically normal at enrollment but randomly     selected for active follow-up. This second group will be seen once after enrollment, at their     fifth anniversary in the cohort. Women in this group with evidence of LSIL at the fifth     anniversary visit will be added to the first group described above and followed at 6-month     intervals. The final group consists of the remaining women in our cohort (all cytologically     normal at enrollment). These women are being followed passively via linkage to the cytology     and tumor registries in Cost Rica.      Clinical visits conducted during follow-up consist of a brief personal interview that     collects information on exposures since enrollment, the collection of 15ml blood, and a     pelvic examination. Pap smear is prepared during the pelvic examination, and additional     cervical specimens are collected and used to prepare a monolayer smear (ThinPrep) and for     human papillomavirus and other testing. Similar to the enrollment visit, cervigrams are also     collected from each participant at the time of their follow-up visits.      During follow-up, women with any evidence of progression to HSIL or cancer (by Pap smear,     ThinPrep, cervicography, or by visual inspection) are referred to colposcopy, censored from     the study, and treated by Social Security Administration clinicians using standard local     protocols.   "
190478|NCT00342186|"     This study, conducted by the Beijing University First Hospital of China and the National     Cancer (NCI), will try to identify genes associated with either susceptibility or resistance     to chronic infection by the hepatitis B virus (HBV). Some people recover from HBV infection;     others become chronically infected and may go on to develop severe liver disease such as     cirrhosis or liver cancer. About 350 million people worldwide have chronic HBV infection. Of     120 million infected Chinese, 90 percent of children infected at less than 5 years of age and     10 percent of infected adults develop persistent infection.      HBV-infected and non-infected healthy persons of Han ethnicity born before 1963 may be     eligible for this study. Offspring of infected candidates (born in any year) may also be     enrolled. Infected adults must have at least one infected parent or sibling. Persons who     resided in Fusui County of Guangxi Zhuang Autonomous Region or in the Qidong district of     Jiangsu Province for at least 6 months before 1986 may not participate.      All participants (except offspring of the study subjects) will fill out a health     questionnaire (providing information about eating, drinking, and smoking habits and a     personal and family health history) and will donate no more than 20 milliliters of blood. The     blood will be tested for antibodies, antigens, and other substances that may indicate     infection with hepatitis viruses. Some of the blood will be sent to the NCI for DNA analysis     to identify genetic factors that may influence clearance of the hepatitis virus after     infection or progression to liver diseases associated with HBV infection. Infected patients     who have had a liver biopsy in the past will be asked permission to examine tissue from the     biopsy and to review laboratory results of any tests done for diagnostic and treatment     purposes.      When the study is completed, specimens sent to the NCI will have identifiers linking the     material to the donor removed. The anonymous samples may then be used for other genetic     studies. Specimens remaining in China will continue to have identifiers linked to them and     may be used for future studies designed to identify who is at greatest risk of developing     serious liver diseases. Participants who do not want their blood used for future studies may     request that the samples be destroyed.      Because children inherit one-half of their DNA from each parent, DNA samples from HBV     infected study participants may provide additional information about the parent s DNA     structure. Offspring who participate in this study will provide a DNA sample. The sample is     obtained by swishing a mouthwash in the mouth for 30 seconds and then spitting the mouth wash     into a cup. The DNA is then isolated from the mouth cells.   "
190479|NCT00342199|"     Information from this study is needed to plan an eventual trial of a GAS vaccine in India if     and when one is available. A GAS vaccine is currently a priority of the Indian Council for     Medical Research (ICMR), and this project has been approved by the Joint Working Group (US     and Indian Delegates) of the Vaccine Action Program, a joint effort of the ICMR and NIAID to     implement cooperative efforts between the two countries on mutual objectives in vaccine     development. Currently, several GAS vaccines are in development, supported by NIAID, and     other sources, and one candidate is in phase one clinical trial authorized by the FDA.     Information on the antigenic structure of GAS isolated in India will be needed for planning     vaccine composition. It is the view of the Indian Ministry of Health and Indian Council for     Medical Research that eventual prevention and control of rheumatic fever and rheumatic heart     disease in India, now a heavy burden on the children will require a GAS vaccine, which     requires both access to primary health care and a vaccine if and when it is available.      Information on incidence is needed to determine the size of a future vaccine cohort in order     to obtain a statistically significant result on vaccine efficacy. Although unrelated to     vaccine development, information on the incidence of GAS pharyngitis is needed in India to     implement primary and secondary acute rheumatic fever (ARF) and rheumatic heart disease (RHD)     prevention programs as were implemented in the USA and Europe forty years ago.      A vaccine trial is not part of this study, nor is there any intervention, other than     antibiotic treatment of all children volunteers who develop GAS pharyngitis or impetigo.      An additional point should be made about the importance of obtaining epidemiological data on     streptococcal disease in India, and on the emm types of GAS that cause infections. The     population of India is over one billion people, representing nearly twenty five percent of     the world's population. Information on GAS epidemiology from India is scant to say the least,     and it is sorely needed. We now know that streptococcal toxic shock syndrome and fasciitis     that have occurred in the U. S., Europe, Australia, and Japan, with greater frequency in     recent years are caused by several genetically similar emm types of GAS. The implication of     such genetic and epidemiologic data is that these genetically related strains have spread     worldwide, Current information from India is far too limited to know if these virulent     strains of GAS occur in India, and if they do, to what extent might they be the cause of     frequent invasive disease in hospitalized patients.      Equally important, we do not know if a potentially high virulent GAS strain is currently     emerging in some locale(s) in India, and what possible threat it might become, if it were to     be transported to other worldwide geographic regions. Although not a specific aim of this     proposal, the surveillance conducted to accomplish the aims of this protocol will provide     essential information on the possible emergence of an unexpected emm type with pathogenic     potential.   "
190480|NCT00342212|"     Background:        -  Good measures of physical activity are needed for studies correlating physical activity          and the risk of developing certain diseases.        -  In preparation for use in a study of diseases and risk factors in Hispanic populations,          NCI is evaluating a new model accelerometer to measure physical activity. An          accelerometer is a small device worn on a belt at the waist that measures and records          movement, capturing movement intensity and duration and associating it with clock-time.        -  The new accelerometer (ActiGraph GTIM) uses a different type of motion detector from          that used in the previous model (ActiGraph 7164).      Objective: To evaluate and compare the ActiGraph GTIM with the ActiGraph 7164 by collecting     physical activity data using both models.      Eligibility: Men and women 18-74 years of age.      Design: Study participants wear both model accelerometers while they walk or jog around a     track at several self-selected paces. Data from the two devices are compared.   "
190481|NCT00342225|"     This study will examine changes in mother-child relationships when mothers are pregnant,     because this period may involve conflicts between mothers and children. A widely held     evolutionary theory postulates that because parents and offspring share only about 50 percent     of their genes, conflicts occur and would most likely occur at times when parental investment     decreases. Offspring benefit from obtaining maximal parental investment and may demand more     investment than parents are willing to give at times, perhaps because the parent would better     benefit from directing their energy to other pursuits, such as to other offspring or to work.     This study will explore the following:        -  How pregnant mothers treat their children, in terms of caregiving techniques;        -  Whether mothers exhibit different caregiving patterns at different stages of pregnancy;        -  Whether mother-child conflicts arise during pregnancy, and, if so, when during pregnancy          they are most likely to occur; and;        -  Whether offspring overtly resist changes in maternal behavior during pregnancy, and, if          so, what behaviors children use to resist these changes.      All pregnant Bofi forager women living in settlements near the villages of Ngotto, Poutem,     Bambondji, and Grima (in the Central African Republic) who have one or more living offspring     and have no serious health problems related to pregnancy may be eligible for this study. Bofi     foragers are among the few remaining hunters and gatherers and, as such, offer an opportunity     to examine child developmental theories that have been well studied among industrialized     Euro-American cultures, but neglected cross-culturally. Furthermore, studies among     contemporary hunter-gatherers provide insight into the evolutionary past of humans, as humans     have lived as hunter-gatherers for about 99 percent of prehistory.      Participating pregnant Bofi forager women will be interviewed for demographic information,     family genealogy, fertility history, and parenting beliefs. The women and their children will     be observed for 4 hours on two different days as they carry out their normal daily     activities. Attention will be paid to the mother's investment in terms of direct care of the     children, including behaviors such as holding, cleaning, comforting, grooming, and feeding     children.   "
190482|NCT00342251|"     Age-related macular degeneration (ARMD) affects older Americans and can lead to irreversible     blindness. Although the cause if ARMD is unclear, it appears to be a condition that is     affected by both genetic and environmental influences.      The purpose of this study is to examine an Amish community to investigate genetic factors in     the development of ARMD.      Study participants will be 1,000 members, ages 50 and older, of the Old Order Amish community     in Lancaster and Franklin counties in Pennsylvania. Each will undergo a 30-minute dilated eye     exam during which an ophthalmologist or optometrist will take digital images of the macula     and optic disc. Depending on the results of their eye exam, participants may be asked to give     a blood sample as well. They will also complete a brief questionnaire about personal exposure     related to occupation, sunlight and smoking.   "
190648|NCT00333749|"     Children with acute diseases with oral ulcers (not included PRESENTATIONS OF SLE, IBD or     IMMUNOCOMPRMIZED STATES)will receive several doses (drinking or mouth rinsing) of either     pasteurized goat milk or cow milk. Children will than be followed for length of the disease -     signs and symptoms.   "
190485|NCT00342290|"     Early pregnancy is associated with numerous physiologic alterations - many of which are     required to establish normal pregnancy outcome. Three-dimensional ultrasound may provide new     opportunities to better characterize some of these early changes. This noninvasive method     allows one to arbitrarily scan through a digital ultrasound volume data, visualize organs     from different perspectives, and render anatomical features through computer processing.     Retrospective measurement of distances and volumes are even possible in the physical absence     of the patient.      New information provided by three-dimensional ultrasound may lead to improved understanding     about how to counsel parents regarding early pregnancy complications such as bleeding. For     example, vaginal bleeding complicates approximately 15-20% of first trimester pregnancies. A     common association is subchorionic hemorrhage which is associated with increased risk for     miscarriage, preterm delivery, preterm premature rupture of membranes, stillbirth, and     placental abruption. Several studies have attempted to characterize subchorionic hemorrhage     by conventional two-dimensional ultrasound which is not particularly well-suited for accurate     measurement of small irregular hematomas. Consequently, there has been considerable debate     about the significance of this finding especially in asymptomatic women who undergo prenatal     ultrasound examination for other reasons.      This protocol will attempt to identify prognostic indicators of adverse pregnancy outcome. A     maximum of 400 pregnant women up to 20 weeks' gestation with sonographically detected     subchorionic hemorrhage will be serially studies to characterize sac volume, placental     volume, hematoma volume, and placental blood vessel patterns by 3DUS techniques. These     results will be correlated with pregnancy outcome, hormonal markers, and placental pathology.     This information is expected to improve our understanding of the natural history of     subchorionic bleeding and spontaneous miscarriages as well as prognostic factors influencing     pregnancy outcome in both symptomatic and asymptomatic women.   "
190486|NCT00342303|"     We will test the following hypotheses:        1. The activity of the desaturating/elongating enzymes assessed by the in vivo conversion          of deuterated a-linolenic and linoleic acids to DHA and AA, respectively, will be          related to the duration of gestation and to postnatal age.        2. Dietary w-3 and w-6 LCPUFAs in human milk or DHA and AA supplemented formula will          inhibit the desaturation/elongation of deuterated a-linolenic and linoleic acids          demonstrating in vivo inhibition of the metabolic pathway by respective products.      Present evidence suggests that the parent essential fatty acids (EFA), linoleic acid (18:2     w-6) and a-linolenic acids (18:3 w-3) are insufficient to fully satisfy EFA nutrition during     early life in the human. A possible need for long chain (LC, longer than 18 C chain length)     EFAs in the human is suggested by the accretion rates of elongated and desaturated products     in the developing fetus; the altered plasma and red cell fatty acid patterns, and the     abnormal visual function observed in infants receiving solely the parent EFAs; and by the     relatively high concentration of LC EFAs in human milk. Most milk formula, as compared to     human milk, are lower in oleic acid, higher in linoleic, have little a-linolenic acid and     virtually no LC w-3 or w-6 polyunsaturated FA (LC PUFA). This study will evaluate the     capacity of human infants to form w-3 and w-6 LCPUFAs from the parent EFAs as affected by     developmental stage and dietary EFA supply. The precursors will be labeled with deuterium and     the products analyzed by gas chromatography / mass spectrometry GC/MS. The main products of     the desaturation / elongation pathway are docosahexaenoic (DHA) and arachidonic (AA) acids     for the w-3 and w-6 series, respectively. Infants will be fed human milk or formulas with or     without supplemental LCPUFAs as part of a study to evaluate the effect of EFAs on CNS     functional development. Infants included in this study of the effect of developmental stage     on EFA desaturation/elongation will be 2-5 days of age (before any fat is administered     enterally or parenterally) and 28, 32, 36 or 40 weeks gestation. In addition, infants born at     28 and 40 weeks gestation will be studied 2 and 6 weeks postnatally after dietary fat has     been provided for at least 7 days and energy intake is sufficient to assure growth. To     evaluate the effect of dietary EFA on DHA and AA formation we will assess elongation/     desaturation in infants receiving 3 diets: human milk (which contains w-3 and w-6 LCPUFAs);     cow milk based formula providing 18:2 w-6 and 18:3 w-3 but no LCPUFAs; or formula     supplemented with added LCPUFAs (DHA and AA). This study should provide new information on     the effects of developmental stage and w-3 and w-6 LCPUFA supply in determining the activity     of EFA elongation/desaturation in the human. This knowledge may help in improving early     neonatal nutritional practices to assure meeting the EFA needs of the developing CNS.   "
190487|NCT00342316|"     This study compares overall survival between patients with acute myeloid leukemia, who are in     complete remission following initial treatment with chemotherapy and whose remission is     maintained either with a transplantation of stem cells obtained from a sibling or unrelated     donor or with standard treatment, which is additional chemotherapy.      The study hypothesis is that the group transplanted with stem cells from a donor will have a     superior survival compared with patients treated with standard of care.   "
190488|NCT00342329|"     The purpose of this study is to examine hormonal and environmental risk factors (and possible     gene-environmental interactions) involved in the etiology of lupus nephritis. Our study will     focus on exposures to occupational and environmental agents that have been linked to the     development of systemic lupus erythematosus (SLE) or renal disease (e.g., silica dust,     smoking). We will also assess potential gene environment interactions. We will examine these     exposures in 100 patients with renal biopsy with documented proliferative or membraneous     nephritis. We will compare exposures in the lupus nephritis patients to lupus patients who do     not have nephritis and to normal controls who have participated in the Carolina Lupus Study.     One hundred lupus nephritis patients (age 18 years or older, of both genders and all races)     will be identified through the Glomerular Disease Collaborative Network (GDCN)     Nephropathology database and participating nephrologists at the Medical University of South     Carolina, Duke University Medical Center and the East Carolina Medical School.   "
190489|NCT00342342|"     This study will examine blood specimens from patients with various eye disorders who     previously participated in the Beaver Dam Eye Study to try to identify genes responsible for     these disorders. The Beaver Dam study was designed to determine the incidence and causes of     age-related eye conditions, including cataract (changes in the lens of the eye that can     impair vision); retinopathy (diseases of the retina - the thin layer of tissue that lines the     back of the eye); age-related maculopathy (degeneration or atrophy of the macula - the center     part of the retina responsible for fine vision); and impaired vision. Findings from this     study and others have shown that age-related eye disorders often run in families, indicating     a genetic component in their development.      All participants in the Beaver Dam study who had family members in the study may be included     in the current NHGRI study. The Beaver Dam study included residents of the township of Beaver     Dam, Wisconsin, who were between 45 and 84 years of age at enrollment. Participants had     thorough eye examinations and blood samples drawn at baseline and 5 and 10 years after the     baseline evaluation. Fifteen-year follow-ups will start in 2003.      This study will analyze data and blood samples previously collected from Beaver Dam study     participants to identify genes related to numerous age-related visual traits. No new     participants will be recruited.   "
190501|NCT00342524|"     The purpose of this study is to collect plasma by apheresis from patients who have recovered     from Severe Acute Respiratory Syndrome (SARS). This plasma will be processed into a     SARS-antibody enriched intravenous immune globulin (IVIG) product. This product will then be     available for use in a clinical trial if a SARS epidemic recurs.      Potentially eligible participants are people between 18 and 56 years of age who have     recovered from SARS. Potential participants will undergo three sequential screenings to     determine their eligibility for this study. Eligible participants will then be scheduled for     plasmapheresis. After apheresis, additional testing will be performed on a sample of the     source plasma. Once the sample has been tested and cleared, the source plasma will be shipped     to the United States to the storage facility and finally to the site of manufacturing of the     IVIG product. Participants may donate plasma again after 14 days.      The study will not have a direct benefit for participants. However, participation may help     develop a treatment that could be useful to other people who become infected with SARS.   "
190490|NCT00342355|"     This study will determine how well four different antiretroviral drug therapies work in     patients with advanced HIV disease. The trial is part of the South Africa-U.S. Project     Phidisa Programme - a collaboration between the South African Military Health Service (SAMHS)     of the South African National Defense Force (SANDF), the U.S. Department of Defense, and the     U.S. National Institutes of Health - to help prevent HIV transmission among South African     military and civilian employees and their families.      Members of the SANDF with HIV infection may be eligible for this study. HIV-infected family     members who are 14 years of age and older may also participate. All participants must have a     CD4 count of less than 200 or an AIDS-defining illness.      Participants are randomly assigned to one of the following four antiretroviral drug regimens,     which require taking 5 pills or more every day:        -  AZT (zidovudine) + ddl (didanosine) + EFV (efavirenz)        -  AZT (zidovudine) + ddl (didanosine) + r/LPV (lopinavir/ritonavir)        -  D4T (stavudine) + 3TC (lamivudine) + EFV (efavirenz)        -  D4T (stavudine) + 3TC (lamivudine) + r/LPV (lopinavir/ritonavir)      Patients are followed for up to 6 years. Clinic visits are scheduled once a month for the     first 3 months and then once every 3 months for the next five years. Patients undergo a     medical history, physical examination, and blood tests at each visit, and complete     questionnaires of behavior, quality of life, and force readiness every year.   "
190491|NCT00342368|"     Mechanical ventilation through an endotracheal tube is a lifesaving procedure for acute     respiratory failure. However endotracheal intubation increases patient's discomfort and     stress, and represents one of the most important predisposing factors for developing     nosocomial bacterial pneumonia.      In conscious and cooperative patients non invasive positive pressure ventilation (NPPV) is a     safe and effective mean for treating patients with acute respiratory failure (ARF), improving     gas exchanges and reducing the rate of complication related to mechanical ventilation. Facial     mask, that is the conventional interface for NIV, may induce intolerance because of pain,     discomfort or claustrophobia leading to discontinuation of noninvasive ventilation and     endotracheal intubation. Thus the improvement of the interface between patient and ventilator     seems crucial to achieve a good tolerance allowing the prolonged application of noninvasive     ventilation. Attempting to improve tolerability of patients we used a new interface     consisting in Helmet made in latex-free PVC.      No prospective randomized controlled study has been published on the comparison between     Continuous Positive Airways pressure (CPAP), delivered by an helmet and the medical treatment     with Oxygen supplementation to treat early acute respiratory failure and acute lung injury.      Aim of the present protocol is to compare the efficacy of CPAP delivered with helmet and     conventional medical treatment with oxygen supplementation via Venturi mask, to prevent ETI     in patients with early hypoxemic ARF ( paO2 /FiO2 below 300).   "
190492|NCT00342381|"     The purpose of this study is to investigate fatigue in patients with multiple sclerosis (MS)     and to determine the correlation between the symptom and cerebral changes.   "
190493|NCT00342394|"     This protocol describes an exposure assessment study of farmers in North Carolina and Iowa     who personally apply the fungicides captan, thiophanate-methyl, and benomyl to apple and     peach orchards. The exposure assessment will include environmental measurements as well as     biological monitoring data. The biomonitoring data will be based on 24-hour urinary     metabolites of the three fungicides selected for study. The study is being done in     collaboration with the Argicultural Health Study (AHS), a large prospective health study of     licensed private (farmer) and commercial applicators, and the spouses of private applicators.     The AHS is sponsored by the National Cancer Institute, the National Institute of     Environmental Health Sciences and the Environmental Protection Agency. The study described     here will be conducted by the National Institute of Occupational Safety and Health.      In summary, the objectives of this study are 1) to measure actual exposures to the target     fungicides using both environmental and biological measures of exposure, 2) to identify and     quantify major determinants of exposure, 3) to describe within- and between-worker exposure     variability, and 4) to evaluate, to the extent possible, agreement between exposure estimates     computed using the AHS exposure algorithms and exposure estimates based on actual     measurements.   "
190494|NCT00342407|"     Flight attendants may be at an increased risk of breast and other cancers due to work-place     exposures including cosmic radiation and circadian rhythm disruption form traveling across     multiple time zones. This cancer incidence study will determine whether female flight     attendants are at increased risk of breast and other cancers and whether the risk is     dose-related. The study will include a cohort of approximately 10,000 women who were employed     as flight attendants for one or more years.      Breast cancer cases will be identified from telephone interviews of living subjects and     next-of-kin of deceased subjects, as well as from death certificates. The interview will also     provide information about non-occupational risk factors for breast cancer such as parity.     Both internal and external comparisons will be made. The primary analysis will evaluate the     risk associated with occupational exposure within the cohort, controlling for     non-occupational risk factors by stratification or modeling. The secondary analysis will     compare the incidence of breast cancer in the cohort to that in the general population, with     adjustment for factors such as lower parity which might increase breast cancer risk in the     cohort independent of occupational exposure to cosmic radiation and circadian rhythm     disruption. The risk of other ionizing radiation-related cancers, such as leukemia, lung     cancer, and thyroid cancer, among flight attendants will also be evaluated. The results of     the study will apply to female flight crew and frequent fliers.   "
190519|NCT00342810|"     Since 1948, the Framingham Study has examined a group of men and women every two years for     the primary purpose of studying the incidence and prevalence of cardiovascular disease and     its risk factors. In 1971 the Framingham Study began a study of the offspring of the original     group, including data collection on blood pressure, cigarette smoking, weight, and other     factors that are of interest to studies of eye disease. Researchers gave eye exams to some of     the original group and to the offspring group. Data from these eye exams have been used to     examine risk factors for cataracts, diabetic retinopathy, myopia, and glaucoma.      The purpose of this study is to use the previously collected data for continued research on     eye-related disorders. No new eye examinations will be conducted.   "
190682|NCT00344383|"     The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl     estradiol, an oral contraceptive tablet, given in an extended regimen   "
190495|NCT00342433|"     Although compelling evidence from laboratory studies suggests that androgens play a major     role in prostate carcinogenesis, epidemiologic studies in humans (almost exclusively     serologic studies) have been unable to confirm the hormonal hypothesis. The major limitation     in these serologic studies may stem from difficulty in measuring androgenicity directly at     the target site - the prostate. If circulating hormones do not reflect intraprostatic hormone     levels or androgenicity, it is not clear how we should interpret results from serum/plasma     measurements, and it is unlikely that future serologic studies can clarify the role of     hormones in prostate cancer etiology.      This study is a comprehensive methodologic study designed to collect venous blood and     prostatic tissue from 650 patients (100 Chinese, 500 American, and 50 Italian) undergoing     prostatic surgery (radical prostatectomy, cystoprostatectomy, or transurethral resection of     the prostate) in order to correlate prostate tissue with serum hormone levels, and with     polymorphisms of hormone-related genes (including the androgen receptor and SRD5A2, the gene     encoding 5-alpha-reductase Type II), and to examine characteristics (such as age, smoking,     body size) that might affect serum-tissue correlation. We plan to study the following     hormones: testosterone, dihydrotestosterone, androstenedione, androstandediol glucuronide,     estradiol, estrone, and estrone sulfate. Levels of androgen receptor and its associated     protein in prostatic tissue will also be measured to provide a better estimate of total     intraprostatic androgenicity. We also plan to collect saliva from 100 of these cases in the     Washington, D.C. area and 100 of these cases in China, to assess whether this non-invasive     tissue collection method is valid for hormone measurements. Finally, urine collection from     100 of these Chinese men is planned for study of androgen metabolites.      Additionally, we plan to include 200 Chinese subjects for blood collection without tumor     tissue for gene polymorphism studies, bringing the total number of subjects enrolled to 850.      For the 650 subjects providing prostate tissue, 30-ml of fasting blood will be collected for     hormone and polymorphism analyses, and tissue will be collected at surgery. A 15-minute     interview will be conducted to elicit information on demographic characeristics, tobacco and     alcohol use, body size, and medical history.      The proposed methodologic study will be the first of its kind to investigate androgenicity in     target tissues directly, and the correlation of target tissue androgenicity with circulating     levels of hormones and polymorphisms of hormone-related genes in a well-designed     epidemiologic study. This study will provide critical information to guide future analytic     studies on hormones and prostate cancer.   "
190496|NCT00342446|"     To assess the relations of infertility causes and treatment to cancer risk, we will conduct a     retrospective cohort study of approximately 12,000 women evaluated for infertility between     1965-1988. These women will be ascertained from several large infertility clinics and private     practices in various geographic locations in the United States: Boston, Chicago, Detroit, New     York, and Palo Alto. These practices were selected on the basis of their having large number     of patients who received ovulation stimulating drugs many years in the distant past.     Abstractors reviewed clinic medical records to identify eligible study participants and     abstract data needed to classify causes of infertility and document therapies employed. Using     a variety of tracing sources (including the National Death Index, credit bureaus, and     postmasters), the vital status and location of the study subjects were determined. Subjects     who were traced and identified as alive are being sent a detailed questionnaire that requests     information on their health status as well as on a number of lifestyle practices. For     subjects who report a cancer, medical verification is being sought from the diagnosing     physicians and/or facilities. Death certificates are being sought for deceased subjects.   "
190497|NCT00342472|"     The overall goal of this project is to determine whether polycyclic aromatic hydrocarbons     (PAHs) are contributing to the high rate of esophageal cancer in Linxian, China.      Esophageal cancer is one of the most fatal cancers worldwide with Linxian, China having one     of the highest rates in the world. In the United States esophageal cancer causes     approximately 10,000 deaths each year. It is the fourth most common cause of cancer death in     black males and the eighth leading cause of cancer death in men of all races. Although     several recent studies have identified some of the molecular changes associated with     esophageal cancer, its prevention and treatment within high risk groups continues to be     limited by our inability to identify specific etiologic agents.      Human exposure to PAHs, including benzo [a]pyrene (B[a]P), is associated with an increased     rate of skin, lung, and upper GI tumors and also with an increased mortality from causes     related to atherosclerosis. Evidence, including the preliminary results from histologic and     food analysis pilot studies, supports the idea that this region's high rate of esophageal     cancer may be related to long-term, high-level exposure to PAHs via inhalation of air-borne     pollution and ingestion of food cooked with soft coal.      Thus, to assess the association of PAHs with the high rate of esophageal cancer in Linxian,     China, we plan to analyze samples of food for the presence of PAHs, samples of blood for Hb     adducts (a marker of long-term PAH exposure), samples of urine for 1-OH-Pyrene glucuronide (a     maker of short-term PAH exposure), and samples of coal for characteristics that may be     associated with increased carcinogenesis. We will also administer environmental     questionnaires that will include questions about the type of fuel used for cooking and     heating, the location and type of stove and/or heating unit (i.e., vented versus unvented),     and time spent cooking.   "
190498|NCT00342485|"     Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and     patients who present with different diseases that involve or implicate the immune system     dysregulation (HIV infection, autoimmune diseases and cancer). These PBMC will be studied in     vitro for a number of functional parameters, including generating soluable factors that     inhibit HIV infection, developing patterns of immune dysregulation, and inducing apoptotic T     cell death. The purpose of such studies is to obtain insight into the mechanisms of natural     resistance to viral infections, AIDS pathogenesis, and disease-induced immune dysregulation.   "
190499|NCT00342498|"     We propose to analyze a DNA sample for mutations in the estrogen receptor gene from a patient     who appears insensitive to estrogen hormone treatment.   "
190500|NCT00342511|"     This study will evaluate a method of testing for human papillomavirus (HPV) DNA. For women     who have had Pap test results that are abnormal, a new test can be done for HPV, that is,     viruses that sometimes cause bumpy or flat warts. Such infections all usually disappear by     themselves in 1 or 2 years if someone's Pap test shows a mild abnormality. But if the HPV     does not go away, the infection can slowly lead to cancer of the cervix. Through this study,     researchers will examine patients in conjunction with a colposcopy, that is, a diagnostic     tool to determine the cause of abnormal Pap test results. The researchers hope to improve on     the efficiency of detecting HPV and reducing the risk of cervical cancer.      Patients ages 21 and older who are not pregnant and who have not had a hysterectomy and who     are attending a colposcopy clinic may be eligible for this study. This study will enroll 150     patients. Two pilot studies will be done: one at the Cleveland Clinic, with the use of the     POI sampler (Preventive Oncology International ) and the other at the University of Arizona,     with the use of the Fournier sampler.      In the study part that uses the POI sampler, patients will be recruited from the existing     colposcopy schedule. For the Fournier sampler, patients will be recruited as they attend     their scheduled colposcopy visit. During the procedure, the doctor will collect two     (Cleveland Clinic) or three (University of Arizona) specimen from the patients while the     patients are sitting. A speculum is not placed in the vagina at that time. Then the doctor     will conduct a routine pelvic exam, with the use of a speculum, while the patients are lying     down, and perform the colposcopy. One final specimen will be collected before the the     colposcopic evaluation. Those three or four specimens will be used just for research     purposes, and they make up the only part different from the regular colposcopy exam. The     pelvic exams may sometimes be slightly uncomfortable, and patients may have temporary vaginal     spotting of blood afterward. The collection of additional specimens may also cause slight     discomfort.      The research specimens, which will not be labeled with information that directly identifies     the patients, will be stored at a repository sponsored by NIH. Those specimens would be     tested now or in the future.      Participants will be told about the results of their tests as part of the routine management     of their abnormal Pap results. Women participating at the University of Arizona will receive     $25 for the time they spend in the study. Benefits that patients receive from being part of     this study include helping researchers to discover new ways to prevent cervical cancer.   "
190545|NCT00343187|"     The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in     subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the     face   "
190546|NCT00343200|"     To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the     treatment of men with ED and at least 1 prespecified risk factor who do not self identify as     having ED.   "
190683|NCT00344409|"     To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer     patients receiving multi cycle platinum-containing chemotherapy   "
190503|NCT00342550|"     Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators     have reported that ultrasound evaluation of the cervix can predict the risk of preterm     delivery. Three-dimensional ultrasound may provide additional information about how to best     counsel parents about the chances of premature birth. This technology has the capability for     accurate volume measurements of irregular structures that is superior to conventional     ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better     characterize cervical changes and the risk for preterm delivery.      Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by     three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm     labor will be prospectively studied to characterize cervical morphology and volume as     predictors of preterm delivery risk. These results will be correlated with placental     pathology and pregnancy outcome. We will also compare the performance of conventional     two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This     information is expected to improve our understanding about the nature and timing of cervical     volume changes in relation to pregnancy outcome.   "
190504|NCT00342563|"     The purpose of the study will be to evaluate the efficacy of mecamylamine in reducing alcohol     consumption in smoking and non-smoking alcohol dependent patients.      We hypothesize that mecamylamine will result in a greater reduction of alcohol consumption     than placebo. We further hypothesize that mecamylamine will be effective in reducing both     alcohol consumption and smoking in a subset of alcoholics who also smoke.   "
190505|NCT00342576|"     Patients admitted on this protocol will have, or be suspected of having, one of the lymphatic     filarial infections affecting humans. After routine clinical evaluation they will be studied     in depth immunologically, and their blood cells and/or serum will be collected to provide     reagents (eg., specific antibodies, T cell clones, etc.) that will be used in the laboratory     to address the broader questions of immunodiagnosis, immunoregulation, immunopathology and     immunoprophylaxis. Careful observations of the patients' clinical and immunologic responses     to therapy will be made, as well as long-term follow-up of these changes. It is anticipated     both that the patients will receive optimal clinical care for their infections and that the     specimens collected from them will prove to be valuable reagents for the laboratory studies     of the immunologic responses unique to filarial or other helminthic infections.   "
190506|NCT00342589|"     This study will examine the effectiveness of a new laboratory method for detecting     pneumocystis organisms in a salt-water (saline) oral wash. Pneumocystis infection in people     with weakened immunity especially patients with HIV infection or cancer, organ transplant     recipients and people receiving immune suppressing therapy can cause life-threatening     pneumonia. Currently, pneumocystis infection is diagnosed by sputum analysis or     bronchoalveolar lavage. For the sputum analysis, patients are induced to produce a sputum     sample (liquid discharge from the lung) using a saline mist; however, many hospitals lack the     expertise to perform this procedure. The second method, bronchoalveolar lavage, involves     inserting a flexible tube into the lung and injecting saline to produce a specimen for     diagnosis. This method, however, is time-consuming and can be uncomfortable. New techniques     may allow the use of an oral wash to diagnose pneumocystis, even though an oral sample     contains far fewer organisms than are obtained with the current methods. This study will     examine whether new techniques, such as nucleic acid amplification, may enable a simple oral     wash to be used effectively for diagnosis of pneumocystis infection.      Patients 3 years of age and older with weakened immunity who have acute pneumonia may be     eligible for this study. In addition, people at increased risk of infection with     pneumocystis, including health care professionals, family members of patients, and other     patients in health care facilities, may participate.      Participants will have a medical history and review of medical records to determine their     health status and determine if they have had recent respiratory problems or documented PCP.     They will then provide an oral wash sample. For this procedure, subjects first rinse their     mouth well. Then, they vigorously swish 50 milliliters of saline for 5 to 10 seconds and     immediately repeat the procedure to provide two specimens. Washes may be requested daily,     weekly, monthly, or for a period of time to be specified. Participants will also have two     tubes of blood drawn (total of 20 milliliters, or 4 teaspoons) to test for evidence of     pneumocystis.      Although no other tests are required for this protocol, participants may be asked to provide     optional add'l samples, as follows:      If a sputum or bronchoalveolar lavage sample is required in the course of the patient s     clinical mgmt, enough material will be obtained, if possible, for research purposes as well     as what is needed for routine care.      An induced sputum sample may be requested just for this protocol. For this procedure, a mask     with a saline mist is placed over the face, inducing a cough that, it is hoped, will produce     sputum from the lungs.   "
190507|NCT00342602|"     This study will identify genetic factors associated with the development of progressive     multifocal leukoencephalopathy (PML) in patients with acquired immunodeficiency syndrome     (AIDS). PML is a life-threatening infection of the brain that affects about 5 percent of     untreated patients with AIDS. Its symptoms include mental deterioration, vision loss, speech     disturbances, ataxia (inability to coordinate movements), paralysis, and coma. PML is caused     by a polyomavirus called the JC virus.      It is estimated that up to 80 percent of the human population has been exposed to the JC     virus, but the disease is very rare. The virus only becomes active in people who have     compromised immune systems, such as those undergoing immune suppressive chemotherapy for     cancer and those with damaged immune systems due to HIV.      Patients who have participated in the Multicenter AIDS Cohort Study may be eligible for this     study, as well as healthy normal volunteers who will serve as controls. The study will review     clinical information from patients and analyze genetic factors from both patients and control     subjects to investigate genes associated with AIDS and JC virus infection.   "
190684|NCT00344422|"     The purpose of this study is to determine how well newly diagnosed multiple myeloma patients     respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection)     and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and     Dexamethasone (VAD).   "
190508|NCT00342628|"     The purpose of this study is to evaluate the safety, immunogenicity, and compatibility of our     Vi-rEPA conjugate administered to infants with their routine vaccinations.      We propose to recruit 300 full term healthy newborns in Vietnam and randomly divide them to     receive Vi-rEPA plus DTP, Hib-TT (not yet used in Vietnam) plus DTP, or DTP alone. Consent is     obtained following interviews of mothers during prenatal visits, or after delivery. All     vaccines will be administered at 2, 4, and 6 months. A booster of Vi-rEPA or Hib-TT conjugate     will be administered at 12 months of age and reactions monitored at 6, 24 and 48 hours after     each injection. Maternal and cord blood samples are collected during labor and at delivery.     Blood will be taken at 7, and 12 months of age from all study infants and at 13 months from     infants injected with Vi-rEPA or with Hib-TT at 12 months. The blood samples will be assayed     for Vi, Hib, diphtheria, tetanus and pertussis antibodies.      The levels of serum IgG anti-Vi elicited by Vi-rEPA administered to infants by the above     schedule will be compared to those elicited by this vaccine in 2 to 5 year-olds in the     efficacy trial conducted in Dong Thap Province, Vietnam.   "
190664|NCT00333957|"     Cystic Fibrosis patients continue to have bowel problems even after adequate pancreatic     enzyme supplementation. There may be pathology of the lining of the bowel. Capsule endoscopy     will be used to photograph the entire bowel.   "
190509|NCT00342641|"     This study will investigate the possible relationship between infection with hepatitis C     virus (HCV) and the development of certain hematologic cancers (Non-Hodgkin's lymphoma,     Hodgkin's lymphoma, chronic lymphocytic leukemia, multiple myeloma) and thyroid cancer. HCV     causes chronic hepatitis, cirrhosis, and liver cancer. It is transmitted primarily through     injection drug use and transfusion of infected blood. Studies have shown that HCV may also be     linked to hematologic cancers and thyroid cancer.      This retrospective study will examine medical records from veterans with and without HCV     infection who previously received treatment in the Veterans Administration medical system.     Data collected on each subject will include the subject's race, sex, age and era of military     service, presence of liver disease or thyroiditis at their baseline clinic visit, number of     inpatient visits in the past 5 years and outpatient visits in the past year, and the presence     of various specified cancers. The prevalence of cancer and other conditions among     HCV-infected subjects and non-HCV infected subjects at baseline and the subsequent     development of the cancers of interest in these two groups will be compared and analyzed for     a possible causal relationship.   "
190510|NCT00342654|"     Two large, nutritional intervention trials were conducted in Linxian, China between     1985-1991. These trials tested the effect of multiple vitamins and minerals in the prevention     of esophageal cancer in a population with the highest known rate for this disease in the     world. Results from the trials showed that Beta-carotene + Vitamin E + selenium reduced total     mortality, total cancer mortality, and stomach cancer incidence and mortality.     Multivitamins/minerals also showed reduction in premalignant lesions. Preliminary follow-up     data obtained for the time period after cessation of intervention in 1991 suggests that the     observed benefit for total and cancer mortality is reduced but that the benefit for stomach     cancer remains.      The objectives of the follow-up study are: (1) to continue to determine cancer incidence and     all causes of mortality in trial participants after intervention to permit examination of     potential effects of the interventions on total and cause-specific mortality and cancer     incidence in the post-intervention period; (2) to conduct a cross-sectional nutritional     survey in a subsample of living trial participants to evaluate their nutritional status,     asses the validity of dietary questionnaires, and relate neurologic status to vitamin B12     plasma levels; (3) to collect a blood sample from all living trial participants to permit     further etiologic investigations of genetic and environmental hypotheses; and (4) to perform     nested case-control studies of selected genetic and environmental hypotheses.      To accomplish the objectives of the follow-up study, we will: (1) determine updated vital     status and cancer status data on all trial participants via monthly checks of village doctor     records and quarterly checks of the Linxian Cancer Registry; conduct a Vital/Cancer Status     Interview Survey among all (n-34,000 trial participants (or their surrogates); identify,     collect, and store all available diagnostic materials for trial participants identified as     having developed cancer or died with cancer during the follow-up period; (2) conduct a     Nutritional Survey on a subsample (n-1000) of living trial participants that will include (a)     a physical exam and brief medical history, (b) a neurologic history, (c) a cognitive function     exam, (d) a hair/mouth skin exam, (e) a neurological exam, (f) a nutritional questionnaire,     and (g) collection of a blood sample for hematologic/biochemical analyses; (3) conduct a     Blood Collection Survey of all living trial participants (n-23,000) to obtain (a) a physical     exam and brief medical history and (b) a single 10-ml blood sample for separation and     preservation as WBCs (both viable and nonviable), RBCs, and plasma for genetic (e.g.,     xenobiotic polymorphisms) and environmental (e.g., plasma ascorbic acid) hypothesis testing;     and (4) perform Nested Case-Control Studies of selected genetic and environmental hypothesis     related to the etiology and prevention of esophageal cancer and stroke. These will be done     using serum from the new cancer and stroke cases (-2500) and controls (-2500) previously     identified from 1991-1996, as well as using new cancer and stroke cases and controls for the     period 1996-2004 (-9000).      The followup for endpoints will continue monthly for an additional 5 years (through the year     2003). The Nutritional Survey and Blood Collection Survey will be conducted in the spring of     1999. The Nested Case-Control studies will be performed annually beginning in 2000, and the     Vital/Cancer Interview Survey will be conducted in the Spring of 2001.   "
190511|NCT00342667|"     A major goal of modern perinatal and neonatal medicine is to reduce the rate of developmental     disabilities, especially mental retardation. Cerebral palsy is frequently associated with     neurologic abnormalities and mental retardation. Improvements in neonatal intensive care have     resulted in improved survival of very low birthweight infants but also in an increased     frequency of cerebral palsy. Prematurity is a leading risk factor for cerebral palsy. Two     thirds of preterm neonates are born to mothers with preterm labor with intact membranes or     preterm premature rupture of membranes. A growing body of evidence suggests that these     conditions are heterogeneous. This is an observational cohort study designed to identify the     mechanisms of disease in patients with preterm labor/contractions and preterm premature     rupture of membranes and to describe the relationship between clinical, biochemical,     histological, biophysical parameters and the development of infant neurological disorders.   "
190512|NCT00342693|"     Background:        -  An inadequate filtering system at the Mayak nuclear weapons production facility in          Ozyorsk, Russia, allowed the release of various radioactive materials, particularly          I-131 (radioactive iodine) into the city's atmosphere during the 1950s.        -  A recent pilot study found a higher prevalence of thyroid nodules in Ozyorsk residents          who were exposed to the radiation in childhood during years of heavy atmospheric          emissions (1952-1953) than in children exposed in later years (between 1967 and 1991)          when there were almost no radioactive releases.        -  Understanding the role of I-131 in the development of thyroid disease is important          because I-131 is commonly used in medicine (e.g., to treat hyperthyroidism and thyroid          cancer and to diagnose thyroid disease), and it is the major source of thyroid gland          exposure in fallout from atomic bomb explosions, nuclear power plant accidents, and          atmospheric venting from plutonium manufacturing facilities.      Objectives:      -To expand the pilot study to include 350 Ozyorsk residents who were exposed in childhood to     moderate levels of radiation in order to evaluate thyroid disease in relation to the dose of     I-131 exposure.      Eligibility:      -People who were born and living in Ozyorsk, Russia between 1954 and 1955, the period of mild     radioactive releases from the Mayak nuclear weapons plant.      Design:        -  Participants' thyroid gland and structure are examined with an ultrasound examination          and blood tests.        -  Participants with a possible thyroid gland disorder are referred to specialists for          additional diagnostic procedures.   "
190513|NCT00342706|"     This study will determine the best ways to help teen mothers stay healthy and to increase the     time between their pregnancies to at least 2 years. It is designed to encourage attitudes and     behaviors that are generally thought to be related to longer intervals between pregnancies.     Children of teen mothers generally receive less health care, have lower IQ scores and are     more likely to enter foster care. They have less supportive home environments and higher     rates of incarceration and teen childbearing.      African-American and Latino teenagers living in the Washington, D.C., metropolitan area who     are pregnant with their first baby may be eligible for this study. Mothers or mother figures     of the teens also are encouraged to participate. Candidates must be between 15 and 18 year of     age and speak English.      Teen mothers enrolled in the study take a urine pregnancy test every 6 months during this     2-year study. They are randomly assigned to one of the following two groups:      Usual Care Group: Teens in this group are interviewed by telephone for about 1 hour every 6     months and for about 15 minutes at 3, 9, 15 and 21 months. The hour-long interview includes     questions about the teen's feelings and behaviors, risks to her health and well being, and     how she communicates with her boyfriend and family members. She is also asked about what she     does to reach personal goals, what she thinks about sexual health, and what support she gets     from her family, boyfriend, or others. The 15-minute interview is an update to check on the     teen's health and pregnancy status and to verify contact information.      Intervention Group: Teens in this group are asked the same questions as those in the usual     care group; however, they are involved in a project designed to encourage them to set goals     of furthering their education and training and wait at least 2 years before becoming pregnant     again. Teens in this group are counseled on learning to communicate and work out problems     with their family and boyfriend and on how to keep from getting pregnant again soon. The     participants meet for a 2-hour group session every 3 months at a local health center and are     contacted frequently by a cell phone, which is provided to them at no cost. The phone     sessions are about things that are important to the teens, such as problems in their     relationships, health, sexually transmitted diseases, and preventing another pregnancy too     soon. The conversations are private and take about 45 minutes.      Mothers (or...   "
190583|NCT00343720|"     The purpose of this study is to establish the objective response rate (complete response +     partial response), following treatment with Alimta plus VELCADE, Alimta alone, or VELCADE     alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who     have failed prior preventative therapy for Stage IIIb/IV NSCLC. The Alimta alone treatment     group will be used as the control. The VELCADE single-agent treatment group will be used to     determine if VELCADE administered weekly can demonstrate response rates.   "
190547|NCT00343213|"     P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and     glandular intraepithelial lesions of the cervix. The immunohistochemical staining pattern of     p16INK4a in high grade intraepithelial neoplasia of the cervix (CIN 2 and 3) is diffuse,     whereas in CIN 1 different staining patterns (diffuse, sporadic, focal or negative) can be     seen. The aim of our study is to find out whether the p16INK4a staining pattern of CIN 1 is     able to predict the outcome of the lesion. The retrospective part of the study includes     cervical biopsies of 200 patients with CIN 1 and clinical follow-up for at least 5 years.     p16INK4a staining and HPV detection by IHC will be correlated to clinical outcome.The     prospective part of the study includes 300 patients with CIN 1 and LSIL on cytology. HPV     detection by HCII and p16INK4a immunohistochemistry on liquid based cytology samples as well     as p16INK4a staining and HPV detection by ISH on colposcopy guided biopsies will be     correlated to clinical follow-up and colposcopy findings. Slides are analysed by 2     pathologists without knowledge of clinical data.   "
190514|NCT00342732|"     The prevalence of obesity in the United States has reached alarming proportions with 33% of     adults over the age of 20 being overweight. Obesity is more than twice as prevalent, however,     in the Pima Indians of Arizona. Although there have been a number of advances in our     understanding of the genetics of obesity, the environmental influences on the genetic     expression of obesity requires further investigation.      In an effort to understand some of the influences on the high prevalence of obesity in the     Pima Indians, the present study was designed to investigate eating behaviors and food     preferences, most especially the preference for high fat foods, in sib-pairs of Pima Indians     who have been previously genotyped in our genomic scan for loci linked to diabetes/obesity.     Most specifically, we will utilize several questionnaires and methods of assessing eating     behavior and the preference for high fat foods to create a food intake phenotype. In     addition, we will study Caucasians so that comparisons can be made between these two groups.     We will make these evaluations by assessing eating behavior, food preferences including usual     fat intake and preferences for high fat foods, body image perceptions, and energy     expenditure. It is hoped that the data gathered from this study will elucidate some of the     risk factors for the development of obesity among the Pima Indians.   "
190515|NCT00342758|"     Early life exposures now appear to be important in modulation of the immune response and     tendency to develop asthma. We plan to enroll a cohort of children at birth to study early     life factors in the development of wheezing and respiratory illness during the first six     years of life in Mexico City. In particular, we will consider the role of early diet     (particularly antioxidant intake, lactation and obesity), infections, dust mite and cockroach     antigens, traffic related air pollution, and environmental tobacco smoke. We will also     consider the potential modifying effect of genetic predisposition with respect to the     exposures of interest.      Approximately 6,800 children will be enrolled at birth. The goal is to follow the cohort     though age 6. To increase the number of expected cases of asthma, we will partially enrich     the cohort for increased risk of asthma by virtue of having a parent with doctor diagnosis of     asthma or allergies; the remaining cohort will not be enriched to preserve generalizability.      Pregnant women enrolled in a prepaid health plan in Mexico City (the Insituto Mexicano de     Seguridad Social, henceforth referred to as IMSS) will be screened for the study and invited     to enrolled their newborns when they come for delivery at one of two IMSS hospitals. An     initial home visit during the first three months of life will include assessment of     environmental exposures and infant diet. Children will be followed through age six with     yearly home visits, monitoring of acute lower respiratory illness during the first year of     life and periodic review of the IMSS medical records.      We have chosen Mexico City because of the relatively low rates of asthma in the face of     prevalent exposures to factors that are thought to increase asthma risk in urban areas in the     United States. These include dust mites, cockroach, airborne pollutants and social factors     such as low income and young maternal age. This pattern suggests that protective factors may     be operating in Mexico City that could shed light on the etiology of worldwide childhood     asthma epidemic. Potential candidates include exposure to certain early infections that shift     the developing immune system away from the pattern of allergic asthmatic response. We are     also especially interested in potential protective effects of early nutrition. Exposure to     ozone in this population is the highest in North American and thus antioxidant intake may be     especially important. In order to evaluate these protective hypotheses, we will also collect     information on risk factors believed to be related to increased risk of asthma in US cities     such as allergens, traffic related air pollutants, and lower respiratory infection with     respiratory syncytial virus.   "
190516|NCT00342771|"     This study will examine the association of genetic variants and gene expression patterns with     the risk of prostate cancer. There will be (It will include?) genotype analysis of blood DNA     from 600 patients with the disease and from 600 healthy people, and there will be a gene     expression analysis of prostate tumors. Prostate cancer is a leading cause of death among men     in Western countries. It is estimated that 220,000 or more new cases of the disease will     occur in the United States during 2004. The disease incidence is rising. About 25% to 30% of     the cancers become aggressive. The nonhereditary disease rarely occurs in men who are younger     than age 40. There are large differences in incidence by geography and race. The highest     rates are seen among African-American men in the United States. Also, although Caucasians     have a lower rate of disease incidence and mortality in the United States, the rates among     them are high compared with rates in some European countries. The reasons for such     differences are not well understood, but both environmental and genetic risk factors are     thought to be involved.      Patients ages 40 to 80 years who have had prostate cancer confirmed within the past 6 months,     who reside in Baltimore City or adjacent metropolitan counties, and who were born in the     United States may be eligible for this study. They will be recruited in collaboration with     the Departments of Pathology and Urology at the University of Maryland and the Baltimore     Veterans Affairs Medical Center. Those men serving as controls in this study will be     identified through the Department of Motor Vehicles database and will be matched by age and     race with the patients who have cancer. The study will include 600 participants with prostate     cancer and 600 participants in the control group.      Trained interviewers will administer two questionnaires. The primary questionnaire will be     used to assess information such as medical and cancer history, tobacco use, current     medications, occupational history, family medical history, and socioeconomic status. A     supplemental questionnaire will pertain to patients' exposure to risk factors for prostate     cancer. It will assess the human body, diet, medical history, family medical history, and     sexual history. The section on sexual history will be self-administered.      Patients will undergo collection of blood and urine for various tests. For cancer patients     with prostate surgery, there will also be a collection of tissue, to be performed at the time     that the prostate gland is scheduled for surgical removal. The pattern of gene expression     will be analyzed in low- and high-stage tumors.      There will be no direct benefit from participating in the study, but participants will     receive an incentive of up to $75 to participate in the study. No form of treatment is     involved in this study. However, it is hoped that the study findings will improve     researchers' understanding of prostate cancer biology with respect to the causes of the     health variances between African-Americans and Caucasians.   "
190517|NCT00342784|"     This study will identify genes that predispose men to prostate cancer and affect the rate and     type of disease spread, the aggressiveness of the disease, and the long-term outcome. Several     studies show there is a genetic component to prostate cancer susceptibility, and that a     first-degree relative with prostate cancer increases a man's risk 2- to 3-fold compared to     those without a family history. The risk is significantly higher if the relative was     diagnosed at younger than 65 years of age, or if three or more first-degree relatives are     affected.      The study will try to locate prostate cancer genes in DNA samples using two methods: linkage     analysis and association studies. Traditionally, the search for a disease gene begins with     linkage analysis, in which the aim is to find the rough location of the gene relative to     another DNA sequence, called a genetic marker, whose position is already known. In genetic     association studies, genes from a large number of patients are compared with healthy controls     who are matched by age, race, and geographic region.      DNA samples for this study come from patients in the two following studies at the Fred     Hutchinson Cancer Research Center, Seattle, Washington:      Family study: Participants are families with prostate cancer who have: 1) three or more     first-degree relatives with prostate cancer; 2) three generations with prostrate cancer     either through the maternal or paternal side of the family; or 3) two first-degree relatives     with prostate cancer diagnosed before age 65 or who were African American.      Population-based study: Participants are patients with prostate cancer and matched healthy     control subjects.      The identification of prostate cancer genes important in susceptibility to the disease and     its aggressiveness may permit earlier detection and development of more directed and     effective treatments based on underlying genetics.   "
190518|NCT00342797|"     A series of 1,729 retinoblastoma (RB) patients were identified from medical records at     hospital centers in Boston (1937-84) and New York (1914-84). The study cohort consists of the     1,604 patients who survived at least 1 year after RB diagnosis. Information was obtained from     medical records and interviews conducted in 1987 and 1993. RB patients had a 30-fold excess     risk of another cancer, and a 50% chance of developing a cancer if they survived to 50 years     of age. Blood samples have been collected from 481 patients, and studies are underway to     determine if certain mutations in the RB1 genes are associated with increased or decreased     penetrance or with increased risk of subsequent cancer development. The study population in     New York is being expanded currently to include patients treated since 1984, and their     medical records are being abstracted. Blood samples will be collected from the newly     identified patients who are returning to New York Hospital for a followup RB exam.   "
190584|NCT00343733|"     The purpose of the study is to evaluate the efficacy and safety of OraVescent fentanyl     treatment compared to placebo treatment monthly over a 12-week treatment period in     alleviating breakthrough pain (BTP) in opioid-tolerant patients with noncancer-related     chronic pain.   "
190520|NCT00342823|"     Visceral leishmaniasis is a potentially fatal disease caused in South America by the     protozoan Leishmania chagasi. In neighborhoods with high exposure rates, the outcome of human     infection with L. chagasi ranges from asymptomatic to a disseminated wasting disease called     visceral leishmaniasis (VL). Several studies document familial clustering of VL in     populations at risk. Segregation analyses favor a genetic over an environmental model for     susceptibility to L. chagasi infection. A peri-urban outbreak of VL near the Universidade     Federal do Rio Grande do Norte (UFRN) in Natal, northeast Brazil, has allowed us to identify     endemic neighborhoods with ongoing transmission of L. chagasi infection. Natal is ideal for     this study because endemic neighborhoods are easily accessible, people are motivated to     cooperate with measures to control VL, and other forms of leishmaniasis are not transmitted     in the region. Dr. Jeronimo of the UFRN, and Dr. Mary Wilson at University of Iowa have     collected clinical data and DNA from 400 VL families living in these endemic neighborhoods.     We have created an unprecedented cohort through which we can identify four distinct     phenotypic responses after L. chagasi exposure. We documented familial clustering of L.     chagasi infection, and results of both correlation and segregation analyses are consistent     with the hypothesis that genetic factors predispose, in part, to the diverse clinical     outcomes after infection. Polymorphism in the TNF locus is associated with developing     symptomatic as opposed to asymptomatic disease after infection. We recently completed a     genome-wide scan of the quantitative immune response (DTH) and identified potential linkage     regions on chromosomes 2, 13, 15 and 19. We have also identified a small linkage peak on     chromosome 9 for VL. In our ongoing study, we will next perform fine mapping of these regions     using dense SNPs to identify genes that may determine susceptibility to L. chagasi infection.     Additionally, we will also analyze candidate genes for association/linkage with     susceptibility to or protection from L. chagasi disease. We recently identified an     association on chromosome 5 with the DTH immune response among two linkage disequilibrium     blocks spanning multiple immune related genes.   "
190521|NCT00342836|"     This study will examine tissue specimens from patients participating in a trial of high-dose     myo-inositol to prevent lung cancer. The trial, conducted at the British Columbia Cancer     Agency-Vancouver Cancer Center (BCCA-VCC), includes people who have pre-cancerous changes in     the air passages of their lungs.      The BCCA-VCC trial was designed to determine side effects of taking large amounts of the food     supplement myo-inositol for longer than a month and if the supplement can help smokers stop     smoking.      The current study will look at the levels of a substance called Akt in tissue samples     obtained from air passages of subjects in the BCCA-VCC trial. Akt is activated by tobacco     components and can be found in lung tumor specimens and pre-cancerous lesions. Myo-inositol     may affect Akt levels and help prevent progression of pre-cancerous lesions to cancer.      People participating in the BCCA-VCC phase 1 myo-inositol trial are eligible for this study.     Tissue samples obtained from air passages of these patients during their participation in     that study will be sent to the National Cancer Institute for analysis of Akt levels.   "
190522|NCT00342849|"     The Treatment of Lead-Exposed Children (TLC) clinical trial compared the effect of lead     chelation with succimer to placebo therapy. TLC was a randomized, double-blind,     placebo-controlled clinical trial with sites in Cincinnati and Columbus, Ohio, Philadelphia,     Pennsylvania, Baltimore, Maryland and Newark, New Jersey. The study was designed to test     outcomes in IQ, neuropsychological function, behavior, physical growth and blood pressure     three years after initiation of treatment. Enrollment was conducted between 1994 and 1997,     with completion of the initial three-year follow-up in 2000.   "
190523|NCT00342862|"     This is an observational, exposure-registration and follow-up study, to be conducted in the     United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant     subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the     risk of major birth defects.      The AMEVIVE® Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development     and will be managed by INC Research. The Registry will be monitored by an independent     Advisory Committee of external experts in relevant specialties of teratology, epidemiology,     maternal and fetal medicine, and infectious disease medicine (external member details     available upon request).   "
190524|NCT00342875|"     Data from the new cancer atlas covering the period 1974 1994 indicates that deaths from     bladder cancer among white men and women are elevated in the northeastern United States,     particularly the northern parts of New England. The reason for these elevated rates of     incidence of and deaths from bladder cancer is unknown. Only part of the excess risk can be     explained by exposure to the textile and leather industries.      The purpose of this study is to determine the factors that contribute to the high rates of     incidence of and death from bladder cancer in northern New England. The main objectives are     to:        -  estimate the risk of developing bladder cancer associated with inorganic arsenic in          drinking water, other water contaminants, tobacco use, occupational exposures,          residential proximity to industrial sites, dietary factors, ethnicity, and use of          wood-burning stoves.        -  estimate the extent to which water containing inorganic arsenic explains the increased          rates of bladder cancer.        -  estimate the extent to which exposure to other risk factors explains the increased          rates.        -  evaluate risk of bladder cancer according to genetic factors.        -  examine interactions of these factors with tobacco use, occupational exposure, and          environmental exposure to arsenic and other compounds.      All people ages 30 79 with confirmed cases of bladder cancer will be eligible for the study.     Twelve hundred people with bladder cancer and twelve hundred individuals with no previous     bladder cancer will be included.      After potential participants are recruited and agreement is obtained over the telephone, they     will complete a calendar and collect toenail clippings prior to the home interview. During     the home visit, an investigator will administer a computer-assisted personal interview,     collect drinking water samples and the clippings, and obtain a global positioning satellite     reading. Other biological samples, such as saliva samples, urine, and blood, may be     requested.      Private wells at any previous homes of participants will also be sampled. The location of     previous homes will be determined and the current homeowner will be asked to allow sampling     of the well.      The associations between bladder cancer and environmental exposures will be examined and the     extent to which exposures to such risk factors explain the elevated mortality and incidence     in northern New England will be estimated.   "
190525|NCT00342888|"     Childhood leukemia is the most common type of childhood cancer and its etiology is largely     unknown. Most case-control studies of childhood leukemia have reported elevated risks among     children whose parents were occupationally exposed to pesticides or who used pesticides in     the home or garden. Investigators at the University of California at Berkeley (UCB) conducted     a case-control study of childhood leukemia in 35 counties in the San Francisco Bay area and     the agricultural Central Valley of California. A major focus of the UCB study is to evaluate     whether household or occupational exposure to pesticides increases the risk of childhood     leukemia. Our collaboration provided additional funding to collect carpet dust samples for     the measurement of pesticides and other chemicals. For 470 participants, we attempted to     collect carpet dust using a special high volume small surface sampler (HVS3) vacuum and by     taking dust from participants vacuum cleaner. As of July 2006, dust samples will be collected     only from participant's vacuum cleaner. Samples were collected at a home visit approximately     3-6 months after the first in-person interview. We will also provide support for mapping of     the crops (i.e., determining crop field boundaries and crop species) within 1200 meters (3/4     mile) of residences so that the residential proximity to agricultural fields treated with     pesticides can be determined. We will conduct the epidemiologic analysis of pesticide and     other chemical levels in carpet dust and risk of childhood leukemia. We will also evaluate     whether residential proximity to agricultural pesticide use is associated with risk of     leukemia. Further, we will conduct an Exposure Pilot Study that will include a subset of the     study population. Two components of the Pilot Study will evaluate how well a used vacuum bag     and a window sill wipe predict pesticide and other chemical concentrations in carpet dust     samples collected with the more complicated HVS3 vacuum method. The third component will     compare pesticides detected in carpet dust with pesticides predicted by geographic proximity     to agriculture.   "
190581|NCT00343681|"     This study is designed to generate clinical data as outlined in the Note for Guidance on     harmonization requirements for influenza vaccine marketing authorization by the European     Medicines Agency.      The objectives of the trial are:        -  To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion          influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the          European Medicines Agency        -  To describe the safety of the inactivated, split-virion influenza vaccine, Northern          Hemisphere 2006-2007 formulation.   "
190526|NCT00342927|"     The Family Investigation of Nephropathy and Diabetes (FIND) is a multicenter study designed     to identify genetic determinants of diabetic kidney disease. FIND will be conducted in eleven     centers and in many ethnic groups throughout the United States. Two different strategies will     be used to localize genes predisposing to kidney disease: a family-based genetic linkage     study and a case-control study that utilizes admixture linkage disequilibrium. The center     based at the Phoenix office of the National Institute of Diabetes and Digestive and Kidney     Diseases (NIDDK-Phoenix) will conduct family-based linkage studies among American Indian     populations in the southwestern United States.      Participants (index cases) with diabetes and kidney disease will initially be recruited, and     their parents and siblings will also be invited to participate. Genetic material from these     participants will be used to genotype markers throughout the genome. Linkage analysis will be     conducted to identify particular chromosomal regions containing genes that influence     susceptibility to diabetic kidney disease. Linkage analyses will also be used to identify     genes influencing traits related to diabetic kidney disease, such as serum creatinine,     urinary protein excretion, plasma glucose levels, blood pressure and blood lipid levels.     Regions that show evidence for linkage will then be examined in more detail, with both     genetic linkage and association studies, to attempt to identify the specific genes that     influence diabetic kidney disease, or related traits.      The identification of genes that influence susceptibility to diabetic kidney disease will     lead to a better understanding of how kidney disease develops. In the long run, this may lead     to improved treatment and prevention of diabetic kidney disease.   "
190527|NCT00342940|"     The present study aims to evaluate safety and immunogenicity of one dose of a commercially     available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in     non-elderly adult and elderly subjects.   "
190528|NCT00342953|"     This study will examine long-term health effects of cosmetic breast augmentation     (enlargement) with silicone gel breast implants. There has been concern for some time about     the possible effects of breast implants on the immune system particularly regarding the     development of certain connective tissue disorders and on the possibility that implants may     interfere with the ability to detect breast cancers. More recently, concerns have been raised     regarding the possible cancer-causing effect of the implants themselves. These concerns were     heightened by reports that the polyurethane foam coating that envelops the silicone gel in     some implants may dissolve and produce a chemical called 2,4,-diamino toluene (TDA), which     has been linked to an increased risk of breast and other cancers in rats and mice.      To address this issue, this study will gather information from the medical records and a     questionnaire survey of approximately 12,000 breast implant patients. The questionnaire will     request information on perceived complications of the implants; history of breast     examinations and mammograms; frequency of breast self examination; development of diseases     (particularly cancers and connective tissue disorders) developed subsequent to the     augmentation surgery; potential risk factors for these diseases, such as age at menarche     (onset of menstruation), age at first birth, age and type of menopause (natural or due to     surgery); history of breast biopsies; immune system and connective tissue disorders;     cigarette smoking; alcohol consumption; family medical history, and so forth. To evaluate the     results, the information will be compared with the same data on 4,000 women who underwent     other plastic surgery procedures, such as rhinoplasty, facelift, liposuction, dermabrasion,     eyelifts, and others, from the same practices as the breast augmentation patients.      Participants will be recruited for the study from several large reconstructive and plastic     surgery practices. Among the breast implant patients, women who have had bilateral breast     implants for cosmetic purposes only, and not as breast reconstruction after breast cancer     surgery, will be eligible. Women with a history of breast cancer may not participate.   "
190529|NCT00342966|"     The chemopreventive efficacy of Se was tested in a 10-year human intervention trial; total     and lung cancer mortality, total cancer incidence, colorectal cancer and prostate cancer     incidence decreased. This study is designed to compare, via stable isotope tracer studies the     kinetics of inorganic and organic Se before and following two years of oral supplementation     with L-selenomethionine, to measure forms of Se in the plasma (extracellular Se-dependent     glutathione peroxidase [GSHPx], selenoprotein-P [SeP], albumin-bound Se [AlbSe] and     nonprotein-bound low molecular weight [LMWSe] fractions), and to determine the effects of     supplementation on the ecology of the hindgut microflora. The forms of Se were chosen to     resemble the metabolism of the principal forms of Se in mixed American diets. Sodium     selenite, an inorganic form, is metabolized by reduction to selenide which is then either     used in the co-translational synthesis of SeCys in specific Se-containing proteins (e.g.,     glutathione peroxidases, diodinases, selenoproteins P and W), or is converted to methylated     excretion products; in this sense it resembles the food form selenocysteine (SeCys) which is     metabolized to the selenide level. Selenomethionine (SeMet), an organic form, is a major form     of Se in many foods, particularly those of plan origin. In addition to being metabolized to     selenide, SeMet also enters the metabolic protein pool by competing with the     sulfur-containing amino acid, methionine. A study is proposed to assess the impact of     selenium (Se) supplementation on its metabolism in humans.      A pilot study will be conducted to test recruitment strategies and sample collection,     preparation and analysis and to assess the detectability of two stable isotopes given     together. Four subjects will receive two 300 ug oral doses consisting of 150 ug of the stable     isotope 76Se as selenite and 150 ug of the stable isotope 74Se as selenomethionine on study     days one and twelve. Subjects will be followed for six weeks.      In the first pharmacokinetics tracer study (PK1), twenty-eight subjects will receive the same     two labeled stable isotope doses, and will be followed for 4 months. In addition, two     subjects who have been self-supplementing with 200 ug of Se as selenized yeast for two years     will take part in PK1 to assess the sensitivity over time of the tracer assay in supplemented     subjects. PK1 will be followed by a 2-yr supplementation period, in which all 28 subjects     will receive daily doses of 200 ug of L0SeMet; subjects = metabolism is expected to approach     a new steady state reflective of long-term supplementation. A second 4-month pharmacokinetic     tracer study (PK2) will then be conducted while subjects remain on Se-supplementation with an     extension of six monthly blood samples. Extensive sampling of plasma, urine, and feces during     PK1 and PK2 will permit both the refinement of existing baseline models for selenite and     selenomethionine metabolism in humans and the investigation of changes in metabolism arising     from Se-supplementation. The study is designed to detect a difference of 0.75 standard     deviation units in pre-versus post-supplementation rate parameters, assuming a two-sided test     with an alpha level of 0.05 and a power of 0.80.      The non-absorbed portion of Se may favor portions of the normal colonic bacterial microflora     that produce certain short-chain fatty acids that colon cells use for energy. To test this     hypothesis, fecal specimens will be analyzed for short-chain fatty acids over the course of     Se-supplementation. In addition, the sampling of buccal cell-Se and of toenail-Se on a     quarterly basis over the course of the study and assay of thyroid hormone levels during the     first year of the study will permit the investigation of possible changes in levels resulting     from supplementation.   "
190530|NCT00342992|"     The Alpha-Tocopherol Beta-Carotene Cancer Prevention (ATBC) Study was a large randomized,     double-blind, placebo-controlled, 2x2 factorial design, primary prevention trial testing the     effects of alpha-tocopherol and beta-carotene supplements on cancer incidence and mortality     conducted in Finland as a collaboration between the Public Health Institute (KTL) of Finland     and the U.S. National Cancer Institute. The intervention period ended in 1993, and the     research project was continued as a passive follow-up of participants during the     post-intervention period to monitor potential intervention effects on cancers, as well as     other morbidity and mortality endpoints. The cohort follow-up serves as a basis for cancer     epidemiological research of a wide range of cancer risk factors, biomarkers, and genetic     predisposition based on data and biologic samples collected during the study. This research     is aimed at testing hypotheses relevant to cancer prevention, etiology, and early detection,     and the study material provide an invaluable resource for the study of dietary, biochemical     and molecular hypotheses. The analyses are made particularly informative in that nearly 20     years of follow-up are available for study.   "
190531|NCT00343005|"     This study will determine the highest dose of an experimental vaccine called AMA1-C1 that can     safely be given to adults exposed to malaria. Malaria affects about 300 million to 500     million people worldwide each year, causing from 2 million to 3 million deaths, mostly among     children under 5 years of age in sub-Saharan Africa. It is the leading cause of death and     illness among the general population of Mali in West Africa. Increasing drug resistance to     the malaria parasite, as well as widespread resistance of mosquitoes (the insects that     transmit the parasite) to pesticides are reducing the ability to control malaria through     these strategies. A vaccine that could reduce illness and death from malaria would be a     valuable new resource in the fight against this disease. AMA1-C1 is an experimental vaccine     developed by the NIAID. Early tests of AMA1-C1 in 30 healthy people in the United States     found no serious harmful side effects of the vaccine. This study will look at the effect of     AMA1-C1 in people in Mali who have been exposed to malaria.      Residents of Don gu bougou, Mali, who are between 18 and 45 years of age and are in general     good health may be eligible for this study. Candidates are screened with a medical history     and physical examination, blood and urine tests, and urine pregnancy test for women.      Participants are randomly assigned to receive three injections (shots) of either the     experimental malaria vaccine or a hepatitis B vaccine that is approved and used in Mali. All     shots are given in an upper arm muscle. After the first shot, the second is given 1 month     later, and the third is given 12 months after the first. Subjects receiving AMA1-C1 will get     one of three different doses - low, medium, or high - to find the dose that is safest and     gives the best antibody response to the vaccine. After each shot, participants remain in the     clinic for 30 minutes for observation. They return to the clinic 1, 2, 3, 7, and 14 days     after each shot for a physical examination and to check for side effects. Blood samples are     drawn before each shot and at selected return clinic visits to check for side effects and to     measure the effect of the vaccine.      During the rainy seasons after the second and third vaccinations, subjects come to the clinic     once a month for an examination and a blood test. During the dry season, subjects come to the     clinic 3 months before the last shot is given for an examination and blood test. Additional     blood tests may be done on participants who develop malaria.      If found to be safe in adults, further studies with this vaccine will be done in children     exposed to malaria, as it is children who bear the brunt of this disease.   "
190573|NCT00343577|"     Fabry disease is a rare disorder that often has kidney involvement with increased urine     protein excretion. Proteinuria is recognized as an important risk factor for progression of     chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein     excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry     disease who already are receiving enzyme replacement therapy. A longitudinal, observational     study is being undertaken to determine the utility of these agents in Fabry disease,     realizing that these agents are primarily indicated for reducing systemic blood pressure, and     most patients with Fabry disease have relatively low blood pressures at baseline.   "
190762|NCT00346502|"     The purpose of this study is to evaluate the safety and effectiveness of an experimental 20%     betulinic acid ointment (BA ointment) as a treatment for dysplastic nevi with the potential     to transform into melanoma.   "
190532|NCT00343018|"     This study, conducted by the NICHD in collaboration with Lancaster University in Lancaster,     England, will evaluate the accuracy of information obtained from children using AN ADAPTED     VERSION OF NICHD's interview protocol. The NICHD protocol was developed to help forensic     interviewers OBTAIN INFORMATION FROM children who may be victims of or witnesses to a crime     ABOUT THEIR EXPERIENCES. This study does not involve forensic interviews, but is DESIGNED TO     OBTAIN INFORMATION FROM children ABOUT an event that takes place at their school. The study     will examine how children report a brief interaction with an unfamiliar adult, how the memory     of the event changes over time, and how the use of different interview techniques can help     children give a fuller and more accurate accounts of past experiences.      Children 5 and 6 years of age who attend local schools in the Lancaster, England, area may be     eligible for this study. Participants will be told that they are going to have their pictures     taken and will be escorted by a researcher to a room at the school with another researcher     who is posing as a photographer. The photographer and the child will put on a costume, such     as a pirate's outfit, over their street clothes, helping each other put on pieces of the     costume. The photographer will take pictures of the child in the costume. They will each take     off the costumes and the child will be told that he or she will receive the photographs at a     later time. Another researcher posing as a photographer will come into the room, interrupting     the event, and begin to argue with the first photographer about who had booked the equipment.     They will resolve the argument and apologize to the child for the interruption.      About 6 weeks after the event, the children will be interviewed using the ADAPTED VERSION OF     NICHD interview protocol. Half will be interviewed first about the staged event (the photo     session), followed by an interview about a fictitious event (e.g., a class visit to the fire     station) that could plausibly have happened but did not. The other half of the children will     be interviewed first about the fictitious event and then about the staged event. The children     will be interviewed according to one of the following three procedures:        -  The NICHD protocol preceded by a rapport-building phase that includes the rules of the          interview and open-ended questions about the child and a recently experienced event        -  The NICHD protocol preceded by a rapport-building phase that includes the rules of the          interview and direct questions about the child and a recently experienced event, or        -  The NICHD protocol preceded by the rules of the interview and open-ended questions about          the child, but no opportunity to practice talking about a recently experienced event.      After the interviewer has elicited as much information as is likely to be gained from verbal     questions, he or she will present the child with a line drawing of a gender neutral person     and ask the child to indicate where the child was touched by the photographer and where the     child touched the photographer. Any child who provides a report of the fictitious event will     be interviewed in the same way about the fictitious event. After 1 year, the children will be     interviewed again in the same manner as the 6-week interview.      The interviews will be audio- and videotaped to record the kind of information the children     talk about and compare it to what actually happened in the event.   "
190533|NCT00343031|"     Experimental studies have documented the p'p-DDT, p'p-DDE (a metabolite of DDT) and other     organochlorine (OC) compounds have estrogenic and/or antiandrogenic activities capable of     altering normal endocrine functions. It has been postulated that exposure to these toxins     during embriogenesis may cause urogenital malformations. However, this hypothesis has not yet     been evaluated in humans populations with relatively high levels of exposure. The primary     goal of this project is to study in utero exposure to DDE in relation to anogenital distance     in humans. Anogenital distance is measured from a gender and species specific landmark on the     genitalia, such as the junction of the penis and the scrotum in male humans, to the center of     the anus. Altered anogenital distance is a sensitive manifestation of prenatal endocrine     disruption in animal models; whether it is a sensitive endpoint in humans has not been     studied. We will test the hypothesis that DDE, an androgen-receptor blocker, decreases     anogenital distance in male humans who have been chronically but not occupationally exposed     to DDT in Mexico. Study participants will be newborns and their mothers who live in the state     of Chiapas, Mexico and who have been exposed to DDT through house spraying programs to     control malaria in this area. Anogenital distance will be measured at birth and in utero     exposure to DDE will be determined by measuring DDE in maternal blood.      Demonstration that p'p-DDT or p'p-DDE may interfere with normal endocrine functions during     embriogenesis will provide a model to increase our understanding of how other- more     prevalent-environmental estrogens may act and will open new possibilities for research and     potential control of etiologic factors related with this important public health problem.   "
190534|NCT00343044|"     The purpose of this study is to evaluate the clinical safety and toxicity of intravenous     bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1,     8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian     tube and primary peritoneal cancer.   "
190535|NCT00343057|"     To assess the impact of standardized written information on outcome in acute LBP.   "
190536|NCT00343070|"     Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and     after 8 weeks   "
190537|NCT00343083|"     The purpose of this study is to evaluate the response of the tumor to the treatment regimen     that will be used in this study. This study will also test the safety of cetuximab (C225),     given with chemotherapy and radiation therapy. We also want to see what effects (good and     bad) cetuximab, chemotherapy, and radiation therapy have head & neck cancer.      C225 has been designed to stop the growth of the tumor by blocking certain chemical pathways     that lead to tumor cell growth. In prior studies with head & neck cancer patients, C225 has     delayed tumor growth and provided relief of symptoms in some patients.   "
190538|NCT00343096|"     This study aims to address the hypothesis that Lorazepam (an anticonvulsant) is as effective     when given via the intranasal or buccal route as the intravenous route in terminating     convulsions in children.   "
190539|NCT00343109|"     This phase II trial is studying how well vaccine therapy works in treating patients receiving     trastuzumab for HER2-positive stage IIIB- IV breast cancer. Vaccines made from peptides may     help the body build an effective immune response to kill tumor cells   "
190540|NCT00343122|"     The purpose of the study is to evaluate agitated saline versus polygeline for detection of     intrapulmonary vasodilatation in patients with cirrhosis.   "
190541|NCT00343135|"     Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue     infections   "
190542|NCT00343148|"     Because AVI-4020 Injection was found to cross the blood-brain barrier, and because AVI-4126     (RESTEN-NG) has potential medical benefit to people with a variety of diseases, including     cancers, this study is being performed to find out if AVI-4126 also crosses the blood-brain     barrier. If it does, then additional investigations could be performed, such as in people     with certain types of cancer.   "
190543|NCT00343161|"     The purpose of the study is to determine whether a maintenance treatment over 12 weeks with     esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it     compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy     (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute     treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.   "
190544|NCT00343174|"     Treatment of acute stroke is still difficult and the only specific drug approved (rtPA) can     only be administered if treatment starts within 3 hours after onset of symptoms. This results     in a still too small number of patients treated with rtPA ( < 15% in best clinical care     institutions ). Ancrod is a differently acting biological drug which has been used for a long     time but not for acute stroke treatment. STAT was the first RCT of medium size to show a     significant benefit/risk ration if treatment starts within 3 hours. ESTAT was designed     closely related to STAT but with a longer 6 hours window and specifically extended     inclusion/exclusion criteria to avoid secondary complications possibly related to a longer     time window.   "
190555|NCT00343317|"     Postpartum infections are among the leading causes of maternal mortality world-wide,     particularly in under-resourced countries. Available data suggests that HIV infected women     are at greater risk of postpartum complications than uninfected women. In South Africa,     HIV/AIDS and related infections are now cumulatively the leading causes of maternal deaths     (though indirectly), with puerperal sepsis among the 5 most common causes.      This was a prospective longitudinal cohort of HIV infected (n = 675) and uninfected (n = 648)     women. These were women in whom vaginal delivery was anticipated, and were recruited at > 36     weeks of gestation during the antenatal period.      Hypothesis - HIV infected women are at increased risk of postpartum infectious morbidity and     this morbidity can be reduced by use of prophylactic intrapartum antibiotics.   "
190556|NCT00343343|"     This trial is conducted in Europe. The aim of this investigation is to explore the safety of     a 4 mm needle compared to a 6 mm needle when injected in children and lean adults with     diabetes.   "
190557|NCT00343356|"     Biochemotherapy (combined immunotherapeutic drugs and chemotherapeutic drugs) has shown     virtue than that use chemical or biological drugs alone in the treatment of some malignant     tumor. Here we investigated the efficacy of sequential intravesical therapy with EPI and BCG     to EPI or BCG alone in patients with transitional cell carcinoma of bladder cancer after     surgical management.   "
190558|NCT00343369|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which     combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.      PURPOSE: This randomized phase III trial is studying different combination chemotherapy     regimens to compare how well they work in treating young patients with acute lymphoblastic     leukemia.   "
190559|NCT00343382|"     RATIONALE: Pilocarpine may decrease vaginal dryness and improve quality of life in patients     with breast cancer It is not yet known whether pilocarpine is more effective than a placebo     in treating vaginal dryness in patients with breast cancer.      PURPOSE: This randomized phase III trial is studying pilocarpine to see how well it works     compared to a placebo in treating vaginal dryness in patients with breast cancer.   "
190574|NCT00343590|"     The purpose of this investigation is to determine the effect of Whole Body Vibration Therapy     (WBV) on balance in a participant with multiple sclerosis (MS) related balance deficits as     measured by the NeuroCom Balance Master, the Sapphire IIME EMG Device and the Kurtzke     Expanded Disability Status Scale (EDSS) and the Berg Balance Score.   "
190575|NCT00343603|"     The purpose of this research study is to evaluate an investigational system that may allow     doctors to show images of the different parts inside the eye that show greater detail than     current equipment can produce.   "
190585|NCT00343746|"     The purpose of this research is to evaluate optical coherence tomography (OCT) and FDA     approved device used to image diseases of the eye. The ultra-high resolution OCT is a     non-significant risk device used in this study. Optical Coherence Tomography may be useful     for early diagnosis and monitoring of different types of eye diseases.   "
190560|NCT00343395|"     Nearly half of all Americans will die from cardiovascular disease caused by the build up of     atherosclerotic plaque within coronary arteries. Most deaths in these patients arise from the     development of acute coronary syndromes (ACS) such as myocardial infarction, unstable angina,     or sudden death. ACS is characterized by coronary plaque erosion or rupture, which is     triggered by endothelial changes, including inflammation, and thrombosis. Diabetes, with     insulin resistance as a major component, has been shown to engender adverse metabolic events     within the endothelial cell [1], including impaired endothelial function, augmented     vasoconstriction, increased inflammation and thrombosis. Activation of the transcription     factors nuclear factor KB (NF-KB) and activator protein 1 (AP-1) induces inflammatory gene     expression, with liberation of leukocyte-attracting chemokines, increased production of     inflammatory cytokines, and augmented expression of cellular adhesion molecules. These     metabolic processes may therefore play a significant role in the development of ACS.The     hypothesis is that rosiglitazone and metformin, or the combination of both may provide     positive anti-atherogenic effect, even among patients without diabetes. This pilot study     proposes to evaluate the effect of placebo vs. combined rosiglitazone/metformin (Avandamet®)     on surrogate blood markers of atherosclerosis activity among non-diabetic and pre-diabetic     patients with known stable coronary syndromes. This will provide further evidence justifying     a large definitive outcomes-based clinical trial.   "
190561|NCT00343408|"     RATIONALE: AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving AZD2171 together with standard combination chemotherapy may kill     more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of AZD2171 when given     together with standard combination chemotherapy in treating patients with advanced non-small     cell lung cancer (NSCLC) or colorectal cancer.   "
190562|NCT00343421|"     The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants     and toddlers when given at 2,3,4 and 12-18 months of age.      Primary Objectives:        -  To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both          are co-administered with Prevenar®.        -  To describe the post-dose 3 pertussis antibody responses.      Secondary Objectives:        -  To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both          are co-administered with Prevenar®.        -  To describe the safety after each vaccination following co-administration with          Prevenar®.   "
190563|NCT00343434|"     RATIONALE: A diet using a soy-based meal replacement may help survivors of breast cancer lose     weight and improve their quality of life.      PURPOSE: This clinical trial is studying how well a soy-based meal replacement works in     helping women with stage I, stage II, or stage III breast cancer in complete remission lose     weight.   "
190604|NCT00344032|"     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.     Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can     lead over time to cervical cancer in women . This study will evaluate the immune response     induced by the HPV-16/18 L1/AS04 vaccine and the safety of the vaccine.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
190564|NCT00343447|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Vaccines may help the body build     an effective immune response to kill cancer cells. Giving cyclophosphamide and rituximab     together with vaccine therapy may kill more cancer cells.      PURPOSE: This randomized phase II trial is studying cyclophosphamide and rituximab followed     by two different schedules of vaccine therapy to compare how well they work in treating     patients with chronic lymphocytic leukemia.   "
190565|NCT00343460|"     This randomized phase III trial is studying APF530 and dexamethasone to see how well they     work compared with palonosetron and dexamethasone in preventing nausea and vomiting in     patients receiving chemotherapy for cancer.   "
190566|NCT00343473|"     The purpose of this research is to evaluate the optical coherence tomography (OCT), to image     diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of     diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage     (eye diseases in the back of the eye) due to diabetes.   "
190567|NCT00343486|"     This study will test the effectiveness and safety of two doses of solabegron against placebo     in reducing the symptoms of overactive bladder.   "
190568|NCT00343499|"     24 week, single center, prospective, randomized, double-blind treatment study of valsartan     (80 mg/bid, increased to 160 mg/bid) or placebo in addition to other general medical therapy     in patients with persistent atrial fibrillation (AF) undergoing electrical cardioversion to     restore normal sinus rhythm (SR).   "
190569|NCT00343512|"     RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and     pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant     docetaxel therapy.      PURPOSE: To evaluate whether dose-dense scheduling with (peg)filgrastim support may improve     the clinical and pathologic complete response rate (pCR) and safety profile of single agent     neoadjuvant docetaxel therapy. To determine the changes in molecular markers that occurs with     single agent docetaxel, tissue will be obtained at the end of the four cycles of docetaxel     (either by repeat biopsy or definitive surgery).   "
190570|NCT00343525|"     The purpose of this study is to determine the safety and tolerability of bavituximab when     administered via an arm vein as multiple infusions and to examine how bavituximab behaves in     the body and how it effects the amount of hepatitis C virus and immune modulators in     individuals with chronic infection.   "
190571|NCT00343551|"     The purpose of this study is to investigate the efficacy (blood pressure lowering effect) and     safety of aliskiren given to hypertensive patients after a missed dose.   "
190572|NCT00343564|"     This study was an early-phase trial arranged into two phases. The Phase I portion was a     dose-escalation study designed to assess the safety, tolerability and to identify the maximum     tolerated dose of SB-743921 in patients with Non-Hodgkin Lymphoma and Hodgkin Lymphoma. Phase     II was intended to assess the activity, safety and tolerability of SB-743921 in patients with     Indolent and Aggressive Non-Hodgkin's Lymphomas exclusively. The Phase II portion of the     study was not initiated.   "
190586|NCT00343759|"     The purpose of this study is to see what kinds of breast tumors will respond to lapatinib.     Lapatinib is an experimental medicine which may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
190587|NCT00343785|"     This clinical trial is studying how well giving cyclophosphamide together with anti-thymocyte     globulin followed by methotrexate and cyclosporine works in preventing chronic graft-vs-host     disease (GVHD) in patients with severe aplastic anemia undergoing donor bone marrow     transplant. Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone     marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune     system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune system and help destroy any remaining abnormal cells. Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving anti-thymocyte globulin before and methotrexate and cyclosporine after     transplant may stop this from happening   "
190588|NCT00343798|"     This phase I multicenter feasibility trial is studying the safety and potential efficacy of     infusing ex vivo expanded cord blood progenitors with one unmanipulated umbilical cord blood     unit for transplantation following conditioning with fludarabine, cyclophosphamide and total     body irradiation (TBI), and immunosuppression with cyclosporine and mycophenolate mofetil     (MMF) for patients with hematologic malignancies. Chemotherapy, such as fludarabine and     cyclophosphamide, and TBI given before an umbilical cord blood transplant stops the growth of     leukemia cells and works to prevent the patient's immune system from rejecting the donor's     stem cells. The healthy stem cells from the donor's umbilical cord blood help the patient's     bone marrow make new red blood cells, white blood cells, and platelets. It may take several     weeks for these new blood cells to grow. During that period of time, patients are at     increased risk for bleeding and infection. Faster recovery of white blood cells may decrease     the number and severity of infections. Studies have shown that counts are more likely to     recover more quickly if increased numbers of cord blood cells are given with the transplant.     We have developed a way of growing or expanding the number of cord blood cells in the lab     so that there are more cells available for transplant. We are doing this study to find out     whether or not giving these expanded cells along with one unexpanded cord blood unit is safe     and if use of expanded cells can decrease the time it takes for white blood cells to recover     after transplant. We will study the time it takes for blood counts to recover, which of the     two cord blood units makes up the patient's new blood system, and how quickly immune system     cells return   "
190589|NCT00343811|"     The purpose of this study is to evaluate the continued efficacy of modafinil treatment,     compared to placebo treatment, in children and adolescents with     attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment.   "
190590|NCT00343824|"     This study is to compare the treatment with two different silver-containing wound dressings:     aquacel AG hydrofiber versus acticoat burn dressing.   "
190591|NCT00343850|"     The purpose of this study is to determine if taking Asacol once a day is as effective as     taking Asacol twice or three times a day in keeping ulcerative colitis inactive, and to     determine which dosing regimen is easiest to follow. Once daily dosing of Asacol is     experimental, and has not been approved by the FDA. Dosing as three times daily is FDA     approved.      This research is being done because the researchers want to learn what the best methods are     for keeping ulcerative colitis inactive, and which way of taking Asacol is most helpful to     subjects in continuing to take a medication to control their ulcerative colitis.   "
190592|NCT00343863|"     RATIONALE: Antiemetic drugs, such as dexamethasone, ondansetron hydrochloride, and     palonosetron hydrochloride, may help lessen or prevent nausea and vomiting caused by     chemotherapy.      PURPOSE: This clinical trial studies how well giving dexamethasone together with ondansetron     hydrochloride or palonosetron hydrochloride works in preventing nausea and vomiting in     patients receiving doxorubicin hydrochloride and cyclophosphamide for early stage breast     cancer   "
190593|NCT00343876|"     Inflammation is associated with worsening outcomes among individuals with CAD; C-reactive     protein is a well-known marker of inflammation. Both healthy patients and those with a     history of CAD who exhibit elevated CRP are at greater risk for cardiovascular events.     Despite CRP's well- documented association with increased risk in the development and     progression of CAD, the specific mechanism of elevated CRP in CAD is not known. One possible     etiology includes a continuous prothrombotic process associated with CAD. Several studies     demonstrate a link between platelet activation and inflammation. If thrombotic processes are     involved in the mechanism of elevated CRP, antiplatelet therapy, including clopidogrel, could     effectively reduce CRP. Preliminary studies have demonstrated a reduction of CRP with aspirin     and a clear association between clopidogrel therapy and reduced CRP, however no randomized     trials have been performed. We hypothesize that the proinflammatory effects of platelet     activation may be inhibited with combined clopidogrel and aspirin therapy.   "
190594|NCT00343889|"     The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T     vaccine in countries that follow the World Health Organization-Expanded Program of     Immunization (WHO-EPI) schedule.      The primary objective is:        -  To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a          lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to          hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.      The secondary objectives are:        -  To describe in each group the immunogenicity parameters one month after the 3-dose          primary series at 6, 10, and 14 weeks of age; and        -  To evaluate the overall safety in terms of any adverse events in the first 28 days after          each injection and any serious adverse events during the entire trial.   "
190595|NCT00343902|"     To determine the effect of hawthorn extract 450 mg bid vs. placebo, in addition to standard     medical therapy in ambulatory patients with NYHA class II to IV chronic heart failure on     submaximal exercise as measured by the 6-minute walk test   "
190596|NCT00343915|"     To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months     after the first dose of the hepatitis B primary vaccination course.      Subjects were aged 11 to 15 years at the time of the primary vaccination course.      At the time of enrollment in the present long-term follow-up study subjects were aged 13 to     18 years.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
190597|NCT00343928|"     This study will assess the behavioral effects of an amino acid mixture thought to influence     serotonin function in individuals who have recovered from anorexia nervosa.   "
190602|NCT00344006|"     Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium     falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's     Medicines and Healthcare products Regulatory Agency.      CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a     public-private partnership with the Medicines for Malaria Venture (MMV), World Health     Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical     Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a     treatment for acute uncomplicated P. falciparum malaria.      The combination of chlorproguanil-dapsone-artesunate (CDA) is being developed to supersede     chlorproguanil-dapsone for the same indication, but the addition of an artemisinin     derivative, artesunate, should provide additional population benefits over     chlorproguanil-dapsone alone. The artemisinins have been demonstrated to rapidly reduce     parasite load and have activity against the sexual stages of the P.falciparum lifecycle. The     addition of a second agent to the chlorproguanil-dapsone combination should also protect     against the selection of resistant strains of P.falciparum.      Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination     Therapy actually available and is considered as the gold standard for the treatment of P.     falciparum malaria. This study will therefore aim to demonstrate the non-inferiority of the     combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days. The key     secondary objectives will compare the Parasite Clearance Times (PCT) and the Fever Clearance     Times (FCT) between CDA and artemether-lumefantrine.   "
190603|NCT00344019|"     This study is designed as a prospective, randomized, placebo-controlled, double-blind     analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to     percutaneous coronary intervention [PCI] (at least 2 hours) in patients presenting with     unstable angina. Only patients with negative cardiac biomarkers, measured on 2 separate     occasions a few hours apart will be eligible for inclusion. Furthermore, patients already on     high-dose statin therapy; patients taking any statin within 24 hours prior to the PCI; and     patients with contraindications to statins will be excluded from the study. The primary     endpoint is a quantitative troponin level at 18-24 hours after PCI. At an enrollment of a     total of 150 patients (75 per group), the study is powered to detect a 30% difference in     troponin level. Secondary endpoints include elevation of creatine kinase (CK) and CK-MB above     the upper limit of normal, change in C-reactive protein (CRP) levels from baseline and     thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade. All patients will be     started on statin therapy the day after the procedure, as deemed appropriate by their     treating physicians.   "
190605|NCT00344045|"     The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol     versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour     cumulative dose of the opioid tramadol in the treatment of postoperative pain following total     hip arthroplasty.   "
190606|NCT00344058|"     Magnesium sulfate is used for seizure prophylaxis in pregnancies complicated by preeclampsia.     There is debate as to how long to continue this therapy after delivery of the pregnancy.     Different schemes have been offered to shorten the exposure to magnesium sulfate after     delivery, with little data. We seek to investigate the effect of shortened magnesium sulfate     therapy on the post-partum recovery phase of mild preeclampsia. Our hypothesis was that     shortened therapy (12 hours versus the traditional 24 hours post-partum) has no effect on     disease course, and will result in significantly shorter exposure to magnesium sulfate.   "
190607|NCT00344071|"     One form of breast cancer, known as inflammatory breast cancer (IBC), is characterized by     diffuse erythema (redness) and edema (peau d'orange) of the breast. This type of cancer is     aggressive and poorly understood. It is rare in the United States (about 4 percent of cases),     but more common in Egypt and Tunisia (up to 23 percent of cases). Conducting a case-control     study of IBC is complicated by several factors, including the lack of standardized criteria     for IBC. In addition, collecting pre-chemotherapy tissue and blood samples from IBC patients     is difficult because treatment begins immediately after diagnosis.      In this pilot study, the National Cancer Institute will collaborate with two major cancer     centers and two hospitals (in Egypt and Tunisia) to determine the feasibility of a     case-control study of IBC. The study will assess the number and characteristics of IBC cases,     the feasibility of identifying cases at diagnosis, and the availability of control subjects;     will collect frozen pre-treatment tumor tissue from five IBC cases to determine whether RNA     isolation is possible; will obtain digital photographs of the breasts of IBC cases; and will     demonstrate collaboration between the institutions and personnel involved in the study. The     study will last for approximately one year.      Participating hospitals will identify IBC cases. Consenting patients will undergo a breast     examination in which the examining surgeon will complete an Initial Examination Form (IEF).     Digital photographs of the breasts (but not face) will be taken and linked to the study ID     number. Tissue examination results will be entered into the IEF. For five selected cases,     additional pre-treatment tumor tissue will be collected and frozen.      This pilot study will assess the availability of controls for a case-control study by     investigating the number and type of admissions to the Ear, Nose, and Throat and     Ophthalmology Departments at participating hospitals during 2000-2003, using computerized     records.   "
190608|NCT00344084|"     This study will examine why some people who become infected with the leishmaniasis parasite     develop skin lesions and others do not. The parasite that causes leishmaniasis is transmitted     by the bite of a sandfly. It can cause skin lesions that may persist for several months,     spread to other parts of the body, and become infected with bacteria. Treated with medicine,     leishmaniasis can be cured completely.      People 1 year of age and older who live in the Mali villages of Kemena or Sougoula may be     eligible for this study.      Participants are injected with a small amount of inactive parasites into the skin of their     arm. People who have a reaction to the test, and thus have been exposed to the parasite, are     examined for skin lesions. Their lesions, if any, are evaluated and treated, and their     participation in the study ends.      Participants who do not react to the skin test are examined for skin lesions every month for     5 months. Those who are 18 years of age or older and have mild leishmaniasis skin lesions may     have a small amount of fluid injected into a lesion in order to remove parasites for     laboratory analysis.      Patients' lesions may be photographed to compare what they look like before and after     treatment. Lesions are treated with an ointment containing an antibiotic and a disinfectant     twice a day for 20 days. The lesions are examined 1 and 3 weeks after treatment is completed     to see if the disease has been cured. A few months later, the skin test is repeated to     determine whether the person has been exposed to parasites over the past year.      A blood sample may be drawn from some participants, depending on whether they have a reaction     to the second skin test and whether they have developed skin lesions. The sample is drawn     only from patients 18-65 years of age.      Some blood drawn for the study may be used for genetic tests.   "
190609|NCT00344097|"     This study seeks to determine whether soy protein supplements reduce the pain that often     occurs following surgery for a lung tumor. Patients are randomized to receive either soy     protein or milk protein prior to and following a thoracotomy for a lung tumor. We are     especially interested in pain severity and pain medication use following surgery and will     measure function and quality of life.   "
190610|NCT00344110|"     Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential     hypertension   "
190611|NCT00344123|"     Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral     treatment regimen for resistant HIV-1 infection in adult patients. Since significant     cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment,     effective treatment strategies are critical to prevent long-term cardiovascular events.     Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is     unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal     drug interaction study is needed before this combination can be recommended. This study will     examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500     mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered     to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is     co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant     clinical interaction will occur.   "
190612|NCT00344136|"     Heart disease and stroke disproportionately affect African Americans in the United States.     These conditions are likely caused by both environmental and genetic factors. This study will     attempt to identify specific genes of African and European ancestral origins that may     influence the development of heart disease in African Americans.   "
190613|NCT00344149|"     Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized     thrombocytopenia.      Splenectomy is the standard treatment for patients who fails the first-line treatment:     corticosteroid. Rituximab, has recently emerged as a promising treatment for ITP. The aim of     the study is to determine whether early treatment with Rituximab can result in durable     remissions, and consequently, lead to the avoidance of splenectomy in a significant number of     patients.   "
190627|NCT00333476|"     Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that     causes a progressive loss of central vision. AMD is the leading cause of legal blindness     among adults age 50 or older in the Western world. AMD presents in two different types -     dry and the more severe wet form. Wet AMD is caused by the growth of abnormal blood     vessels in the macula. Squalamine lactate is an investigational drug that may prevent the     growth of these abnormal blood vessels. This study will test the safety and efficacy of     Squalamine in the treatment of AMD.   "
190628|NCT00333489|"     The objective of this study is to evaluate efficacy, safety and tolerability of the     valsartan+amlodipine association in patients with mild to moderate essential hypertension, in     comparison to amlodipine alone.      Patients should have mild to moderate essential hypertension [grades 1 and 2 of WHO     classification (8)]. The diastolic blood pressure threshold for inclusion in this study is 95     mmHg, as these patients are more likely to benefit from association therapy than patients     with lower diastolic blood pressure.      For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will     not be included in this study. Moreover, patients developing severe hypertension (MSDBP > 110     mmHg and/or MSSBP > 180 mmHg) during the open-label treatment phase will be discontinued from     the study.   "
190641|NCT00333658|"     This research has been designed to learn whether getting regular and specific feedback about     work performance with small rewards for meeting goals helps people to improve their job     performance and leads to better work outcomes, improved mental functioning, and better     quality of life   "
190614|NCT00344162|"     This study will examine a possible genetic basis for preeclampsia, a disorder of high blood     pressure and protein in the urine during pregnancy. Preeclampsia is a major pregnancy     complication affecting both mother and baby. Previous research has shown that preeclampsia     tends to run in certain families. This study will determine which genes may be involved in     preeclampsia.      Women who have had preeclampsia (called the index woman) may be eligible for this study. They     will be recruited through the Preeclampsia Foundation. In addition, the following relatives     of the index woman may be enrolled:        -  The child from the preeclampsic pregnancy        -  The index woman's biological parents        -  The index woman's siblings who have given birth or fathered a child and their family          members      The study will exclude any index women or family members who have had chronic hypertension,     diabetes, polycystic ovary syndrome, or whose pregnancy that involved preeclampsia was a     multiple fetus pregnancy or that was conceived through use of fertility technology.      All women participants fill out a questionnaire to collect demographic data (e.g., age, race,     marital status, etc.) and information on their medical and reproductive history, use of     tobacco and medicines, and other factors that may be associated with preeclampsia syndrome.     Women who have had preeclampsia or hypertension in pregnancy are asked to sign a medical     record release form for study investigators to obtain a copy of the medical record for that     pregnancy. All male and female participants provide a mouthwash rinse sample for extraction     of DNA for gene studies. For babies too young to rinse with mouthwash, a soft brush is used     to brush the inside of the mouth to collect cheek cells.      Mouthwash samples are analyzed for genes that may be associated with preeclampsia.   "
190615|NCT00344175|"     This is a sixteen-week follow-on and 28 week single-blind extension study for patients who     participated in study NK-104-304.   "
190616|NCT00344188|"     This study will examine the natural history of Leishmanial infections and their treatments.     It will provide an opportunity for NIAID staff to learn more about leishmaniasis and perhaps     to improve diagnostic tests for these infections. Patients between 2 and 80 years of age with     known or suspected leishmaniasis are eligible for this study.      Participants will have routine blood tests and a biopsy to confirm leishmanial infection. The     biopsy procedure will be determined by the type of infection local cutaneous leishmaniasis     (LCL), mucocutaneous leishmaniasis (MCL) or visceral leishmaniasis (VL). CL will be confirmed     with a punch biopsy, in which a cookie-cutter type razor is used to remove a small circular     piece of skin tissue. MCL will be confirmed using a thin flexible tube inserted into the     nose. This tube is used to examine the nose and upper airway and to remove a tissue sample,     if an affected area is seen. VL will be confirmed with either a bone marrow or liver biopsy     or a splenic aspirate. For these procedures, a small tissue sample is withdrawn through a     needle placed in the hipbone, liver or spleen, respectively. Some patients may also have a     skin test for leishmaniasis similar to tuberculin skin testing.      Treatment and length of hospital stay are determined by the type of infection. CL may be     treated with Pentostam, amphotericin, amphotericin B, itraconazole or ketoconazole; ML with     amphotericin B, or encapsulated amphotericin; and VL with Pentostam or encapsulated     amphotericin. Pentostam is infused daily for 18 to 28 doses, most as an outpatient. Blood is     drawn 3 times a week for safety tests and an electrocardiogram is done 2 to 3 times a week to     monitor heart rhythm. Amphotericin B is infused every day or every other day for about 30     doses, all on an inpatient basis. Patients undergo hydration (infusion of a large amount of     fluid) just before and immediately after each infusion to protect the kidneys. Blood is drawn     every other day and urine samples are collected occasionally for routine urinalysis.     Encapsulated amphotericin is infused every other day, on an outpatient basis. Blood is     generally drawn every other day to every 2 days and urinalyses are done periodically.     Itraconazole and ketoconazole are taken orally for at least 1 to 3 months, with blood drawn     every 2 to 3 weeks.      Patients may be asked to have photographs taken before, during and after treatment to     document progress. They may also be asked to provide extra blood samples for research     purposes, either through a vein in the arm or through apheresis, a method for collecting     large numbers of cells. For apheresis, whole blood is collected through a needle in an arm     vein and circulated through a machine that separates it into its components. The desired     cells are then removed, and the rest of the blood is returned to the body, either through the     same needle used to draw the blood or through a second needle in the other arm.      Patients with cutaneous leishmaniasis will have a follow-up clinic visit 2 weeks to 3 months     after treatment is completed. If there are no complications, their participation will end at     that time. Patients with mucocutaneous leishmaniasis and visceral leishmaniasis will be     followed every 3 to 6 months indefinitely for routine evaluations and re-treatment if the     infection recurs.   "
190617|NCT00344201|"     Tisseel fibrin adhesive has been used extensively in many forms of surgery. Its use in eye     surgery has been relatively recent. A few studies recently showed it was effective in     securing conjunctival grafts in pterygium surgery, and in securing wounds after glaucoma and     squint surgery.      We sought to confirm its effectiveness in pterygium surgery, as well as prove its     effectiveness in securing other material to the ocular surface such as amniotic membrane. Our     hypothesis is that fibrin adhesive is effective in securing various types of material to the     ocular surface for a sufficient length of time to allow adequate healing before it is     absorbed and degraded.   "
190618|NCT00344214|"     This study will evaluate the effectiveness of a sexual risk reduction intervention in     reducing sexual risk behavior in HIV uninfected, heterosexual people who use methamphetamine.   "
190619|NCT00344227|"     The PrONTO Study was designed to evaluate the response of neovascular age-related macular     degeneration (AMD) patients to intravitreal Lucentis using Optical Coherence Tomography (OCT)     imaging. OCT was then used to determine the need for retreatment after 3 monthly injections     of Lucentis. Patients would be followed for 2 years.   "
190620|NCT00333385|"     The aim of this trial was to compare the safety and efficacy of courses of tobramycin and     ceftazidime, administered intravenously as either thrice daily short infusions or 24 h     continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary     PA infection. In conventional treatment regimens, ceftazidime is administered in the form of     thrice daily short infusions, but pharmacodynamic considerations suggest that continuous     infusion could be more effective.   "
190621|NCT00333398|"     The purpose of this study is to investigate the effectiveness, safety, and tolerability of an     influenza vaccine. Influenza is a highly infectious disease that occurs throughout the world     in the winter months. Infection with an influenza virus is a major public health threat as it     has the ability to spread rapidly and affect large numbers of people. Up to 1359 healthy     adults ages 18 to less than 65 years old will participate in this study for up to 24 days.     Volunteers will receive an injection of either influenza vaccine with thimerosal, vaccine     without thimerosal, or placebo with thimerosal. Volunteers will be asked to document     information about any health changes for 21 days following vaccination. Volunteers will     return to the clinic on days 5 and 21 after vaccination to share this information with study     staff. On day 21, volunteers will have a physical examination. Blood samples will be taken     prior to vaccination and at Day 21 post-vaccination.   "
190622|NCT00333411|"     The purpose of this clinical study is to determine the effectiveness, pharmacokinetics and     safety of several doses of BIRT 2584 XX (100mg, 300mg and 500mg) taken once daily in the     treatment of moderate to severe plaque-type psoriasis. This new medicine will be compared to     a so-called placebo medicine over 12 weeks with a 12 weeks treatment extension possible.   "
190623|NCT00333424|"     The development of a safe and effective vaccine for HIV is the subject of intensive     world-wide research. Various approaches are being investigated in monkey models and humans.     This is a randomized, double-blind trial to evaluate the safety and immunogenicity of a     candidate preventative human immunodeficiency virus (HIV) vaccine strategy in 24 healthy     adult Thai volunteers with no identifiable risk behaviour for HIV-1 infection. Volunteers     will receive three priming vaccinations at weeks 0, 4 and 8 (pHIS-HIV-AE, a DNA vector     delivering AE clade HIV-1 genes). This will be followed at week 12 by single boost     vaccination (rFPV-HIV-AE, non-replicating, recombinant fowlpox virus vector delivering the     same HIV-1 genes). Safety and immunological monitoring will continue to 52 weeks   "
190624|NCT00333437|"     Researchers from the Division of Pulmonary and Critical Care Medicine at University of     California, San Francisco (UCSF) are conducting a study to evaluate whether mycophenolate     mofetil (an immunosuppressive medication, trade named CellCept) is safe and effective for     preventing the lung damage from scleroderma from getting worse.   "
190625|NCT00333450|"     To evaluate the immunological memory against pneumococcal vaccine serotypes in children     primed with conjugate vaccines by administering a booster dose of plain polysaccharide     vaccine.   "
190626|NCT00333463|"     A study to examine patient compliance with once daily glaucoma medication   "
190629|NCT00333502|"     CRLX101 is a nanopharmaceutical comprised of the chemotherapeutic camptothecin (CPT)     conjugated to a linear, cyclodextrin-based polymer. CRLX101 is designed to increase the     exposure of tumor cells to CPT while minimizing side effects.      OBJECTIVES:      • Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CRLX101 when     administered intravenously to subjects with advanced solid tumors.   "
190630|NCT00333515|"     The purpose of this placebo-controlled study is to evaluate the safety, tolerability and     pharmacokinetics of a single dose regimen of human butyrylcholinesterase (HuBChE) in healthy     adults at 3 ascending dosage levels administered IV. HuBChE, which occurs naturally in human     plasma, is being evaluated for prophylaxis and treatment in the event of exposure to chemical     nerve agents (as employed during chemical warfare or as an act of terrorism). Volunteers in     each dosage cohort will be randomized to treatment with HuBChE active drug or normal saline     placebo in a 3:1 ratio. The volunteers will remain in the study for 90 (+/- 7) days. For the     first 3 days following dose administration, they will remain at the clinical trial site as     inpatients and will be closely monitored for patient safety. Afterwards, they will return to     the trial site (at pre-determined intervals) as outpatients for 8 further visits, where     patient safety will be assessed.   "
190631|NCT00333528|"     The purpose of this placebo-controlled study is to evaluate the safety, tolerability and     pharmacokinetics of a single dosage of human butyrylcholinesterase (HuBChE) in healthy     adults. HuBChE, which occurs naturally in human plasma, is being evaluated for prophylaxis     and treatment in the event of exposure to chemical nerve agents (as employed during chemical     warfare or as an act of terrorism). Volunteers will receive a single intramuscular infusion     of either HuBChE or normal saline placebo. The volunteers will remain in the study for 90     (+/- 7) days. For the first 3 days following dose administration, they will remain at the     clinical trial site as an inpatient and will be closely monitored for patient safety.     Afterwards, they will return to the trial site (at pre-determined intervals) as an outpatient     for a further 8 visits, where patient safety will be assessed.   "
190632|NCT00333541|"     This purpose of this study is determine whether the use of internet technology to communicate     with adolescents about contraception is feasible and to determine whether it is more     effective than traditional methods. Study subjects will complete baseline and follow-up     surveys at 3, 6, and 12 months about their contraceptive practice and sexual behaviors.      Subjects with internet access will be randomized to either completing surveys remotely over     the internet through email or to follow-up in clinic on laptop computers.      Our hypothesis is that women who have access to the internet as well as use the internet     regularly are more likely to complete follow-up surveys. This will then in turn allow us to     get a better understanding of contraceptive practices amongst high risk teens.   "
190646|NCT00333723|"     This study was designed to evaluate the safety and efficacy of AVANDIA (rosiglitazone) (8mg     once daily) in African American and Hispanic patients with type 2 diabetes mellitus. As     microvascular and macrovascular disease are significant contributors to diabetes morbidity     and mortality and previous studies suggest that the thiazolidinedione compounds could have     potentially beneficial vascular effects, the effects of rosiglitazone therapy on serum     parameters associated with endothelial dysfunction, vascular inflammation and impaired     fibrinolysis were examined in this study. Improvement in these parameters suggests that     rosiglitazone may provide an additional beneficial vascular effect, apart from its ability to     improve glycemic control.   "
190647|NCT00333736|"     Hypothesis: Patients using enfuvirtide with the Biojector have an improved quality of life,     greater satisfaction, and fewer adverse events compared with using the standard needle.   "
190913|NCT00337337|"     We aim to investigate the beneficial effect of adding grain fiber to daily rice meal in type     2 diabetic patients. We anticipate this intervention will improve glycemia and lipid profile     in these patients.   "
190633|NCT00333554|"     Type 1 Diabetes (T1D) is an autoimmune disease. This means that the immune system (the part     of the body which helps fight infections) mistakenly attacks and destroys the cells that     produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's     ability to produce insulin decreases.      The autoimmune process is thought to be initiated by a gene-environment interaction. The     genetics involved in the development of T1D are fairly well understood. There is a higher     risk of developing T1D with the presence of the human leukocyte antigen (HLA) DR3 or DR4. It     is also known that not everyone with these genes actually develops T1D. Therefore, one or     more environmental factors are thought to contribute to the process of developing T1D.      The consumption of the anti-inflammatory fatty acids, the omega-3 fatty acids, has decreased     significantly in the past 100 years. At the same time a rise in the incidence of T1D,     especially in young children has occurred. Because of the warnings to eliminate fish during     pregnancy, pregnant women are consuming even less omega-3 fatty acids during fetal     development.      Observations have been made that children who have received omega-3 fatty acid     supplementation have a lower risk of T1D. Omega-3 fatty acids could have a protective effect     that may occur during pregnancy, infancy, or both. The mechanism of this protection may be     due to the DHA mediated suppression of the inflammatory response.      Patients at higher risk for T1D have an increased pro-inflammatory environment. We     hypothesize that DHA supplementation during pregnancy and early childhood will block the     initial pro-inflammatory events and prevent development of islet cell autoimmunity in     children at higher risk for T1D.      This study is a feasibility study to determine if a full-scale DHA supplementation study will     be implemented. If a full study is implemented, the primary outcome will be to determine if     nutritional supplementation with omega-3 fatty acids during the last trimester of a mother's     pregnancy and/or the first three years of life for children who are at higher risk of T1D     will prevent the development of islet autoimmunity.   "
190634|NCT00333567|"     This study is designed to investigate the efficacy and safety of a single daily dose of 400     mg lumiracoxib given pre-emptively versus post-operatively in terms of efficacy in reducing     pain associated with ambulatory arthroscopic knee surgery   "
190635|NCT00333580|"     The purpose of this study is to modify and develop measures that reflect outcomes that are     relevant to recovering Veterans and are sensitive to improvements resulting from innovative     gait interventions.   "
190636|NCT00333593|"     Patients within the intensive care unit who have severe infections causing shock and kidney     failure have almost a 60% risk of dying despite antibiotic therapy, surgical drainage of the     site of infection and intensive care support with fluids, nutrition, mechanical ventilation     and continuous artificial kidney support. This persistently high death rate continues to     stimulate the development of new approaches to the treatment of septic shock.      Much clinical and molecular biology research suggests that these patients die because of an     uncontrolled immune system’s response to infection. This response involves the production of     several substances (so called “humoral mediators”), which enter the blood stream and affect     the patient's organs ability to function and the patient's ability to kill germs. These     substances may potentially be removed by new artificial filters similar to those currently     used during continuous hemofiltration (the type of artificial kidney support used in     intensive care).      Recent investigations by ourselves and others, however, have made the following findings:        1. Standard filters currently used in intensive care are ineffective in removing large          amounts of these “humoral mediators” because the holes in the filter are too small to          allow all of them to pass through        2. The standard filters currently used in intensive care are also ineffective in removing          large amounts of these “humoral mediators” because the standard filtration flow through          the membrane is less than 100 ml/min        3. When the filtration flow through the membrane is increased to above 100ml/min, patients          require a lesser dose of drugs to support their blood pressure which is an indirect sign          that the filters are clearing some of the humoral mediators        4. Even when the blood flow through standard filters is increased to above 100ml/min, there          is still not optimal clearing of humoral mediators It is possible, however, that,          using a different filter membrane with bigger holes in it, would make it easier to clear          the blood of these humoral mediators. It is thought that this would be noticeable          clinically in the amount of drugs required to support blood pressure.      A filter that has these bigger holes is now available. It is made of the same material as the     standard filters that are currently used in the intensive care unit, only the holes have been     made bigger to allow these humoral mediators to be removed from the blood. This polyamide     filter is made of synthetic semipermeable material. This material is highly compatible with     human blood. This modified polyamide filter is made of exactly the same compatible material     but the holes in the material are slightly larger through a minor modification of the     manufacturing process.      This larger hole filter has now been used in preliminary studies in humans and has been found     to reduce the blood levels of some humoral mediators. Laboratory studies conducted by     ourselves showed that this new filter can achieve the highest reported clearance of some of     the humoral mediators with minimal effect on useful proteins in blood such as albumin     during hemodialysis. This loss is very small and unlikely to contribute to any detectable     clinical changes.      We, therefore, now propose to study the effect of using new large hole filters with     hemodialysis in patients with severe infections and acute kidney failure.      We wish to compare the effect of this new therapy to that of standard filters. The new     therapy will be considered to be effective if it lowers the amount of drugs used to support     blood pressure and if it lowers the blood levels of some humoral mediators more than     standard therapy. We will also monitor blood levels of important components of blood such as     albumin and electrolytes in each group.      This is a pilot study involving only 10 patients who will each receive 4 hours of the     standard therapy and 4 hours of the new therapy. Which treatment the patient receives first     will be random (like the tossing of a coin). Blood samples will be taken at the start and     after 4 hours of each treatment. The waste product of dialysis called spent dialysate will     also be collected for the measurement of humoral mediators at the start and after 4 hours of     each treatment. The changes in blood pressure and drugs used to support it will be recorded     hourly. As patients involved in the study would normally receive hemofiltration because of     their kidney failure, all the risks and benefits associated with the procedure would be     unchanged. The only risk to patients would come from exposure to a modified membrane and from     having two additional spoonfuls of blood taken.      If this new membrane were found to have a major effect on the blood level of humoral     mediators and on the patients’ blood pressure, further studies would then be justified to     assess its clinical effects (time in ICU, time in hospital, time on ventilator, duration of     organ failure, etc).   "
190637|NCT00333606|"     To investigate whether body acupuncture of acupuncture points specific for hearing influences     the auditory avoked potentials in comparison to puncture of non-specific acupuncture points   "
190638|NCT00333619|"     This project is a randomized controlled trial to test whether a multicomponent,     nonpharmacological intervention improves sleep/wake patterns and functional recovery among     older people undergoing post-acute rehabilitation.   "
190639|NCT00333632|"     The purpose of this study is to determine whether an intravenous infusion of dexmedetomidine     administered to surgical patients intra-operatively will improve the characteristics of sleep     post-operatively.   "
190640|NCT00333645|"     This is a non-comparative, open, multisite prospective estimation study to evaluate the     efficacy and safety of caspofungin in the prophylactic treatment of adults who have received     an orthotopic liver transplant and are at high risk of developing an invasive fungal     infection. It is expected that the proportion of high-risk liver transplant recipients who     develop a documented (proven or probable per European Organization for Research and Treatment     of Cancer/Mycoses Study Group [EORTC/MSG] modified criteria) invasive fungal infection during     the first 100 days after the onset of prophylaxis with caspofungin will be lower than 15%. It     is also expected that the incidence of serious drug-related adverse events will be less than     25%.   "
190642|NCT00333671|"     Diabetic macular oedema is characterized by fluid accumulation in the retinal tissue from     leaking retinal vessels, the capillaries. This state can lead to severe visual loss and     blindness. According to basic physiologic rules several factors influence the fluid transport     between the capillaries and the surrounding tissue. One of these factors is the balance     between the large molecules within the vessel lumen and the retinal tissue. Some drugs change     this balance, the osmotic balance, by moving the fluid from the tissue to the vessel lumen.     In relation to diabetic macular oedema, treatment with such a drug potentially would reduce     the retinal thickness because it extracts fluid from the retinal tissue. Glycerol has this     potential. If reduction of the thickness with glycerol is confirmed, then it proves the     significance of the osmotic balance in the basic nature of diabetic macular oedema.      In this study we therefore examine the time dependent change in retinal thickness after     glycerol intake by an instrument called optical coherence tomography (OCT). The participants     drink glycerol and the thickness of the retina is then monitored closely by OCT during the     following three hours. Since diabetic changes in the retina are focal pr. definition, the     secondary purpose of the study is to find any regional differences in the response. The     examinations are repeated at a second visit where the patient drink another dose of glycerol,     because we also want to analyse for a dose dependent response. Which dose is given at each     visit is randomised on beforehand. In addition to measuring the retinal thickness a variety     of examinations are performed both before and during the study, e.g. blood samples and     systemic blood pressure measurements.   "
190643|NCT00333684|"     Evaluate and record any changes in the Quality of Life and psychological state of the     affected study group following treatment with Bio-Alcamid.      Evaluate the safety and efficacy of Bio-Alcamid for restoring the natural fullness and     contours of the face affected by HIV drug-induced lipoatrophy. Pre-treatment classification     and post treatment recording of changes will be performed by, both, the Principal     Investigator and the Treatment Specialist and independently by a 'Blinded' Co-Investigator at     post treatment Week 12.      Safety data for Bio-Alcamid will be collected throughout the duration of the study. Safety     will be determined by the rates of procedure-related events and adverse experiences     associated with the use of Bio-Alcamid.   "
190644|NCT00333697|"     To determine the rate of thromboembolic complications (including death attributed to     thromboembolic disease) in patients with a score rated as DVT likely on a formalized     scoring system, when anticoagulation therapy is withheld on the basis of a negative     comprehensive duplex ultrasound examination. Participants are followed for three months after     a normal ultrasound to determine if any symptoms attributable to deep vein thrombosis     develop. Any such symptoms are verified by objective tests.   "
190645|NCT00333710|"     The main objective of this proposal is to develop and test the efficacy of two interventions     (a telehealth and face-to-face intervention) designed to improve quality of life, self-care,     motivation to engage in healthcare, and psychological distress in patients diagnosed with HCV     and PTSD. It is hypothesized that   "
190649|NCT00333762|"     The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for     power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in     realistic indoor environments with target users performing realistic tasks. We will combine     group trials involving individuals who have a visual impairment (but do not have a mobility     impairment) with several single-case studio involving individuals who have a visual and     mobility impairment. Our long-term objective is to provide independent mobility to veterans     with mobility and sensory impairments.   "
190650|NCT00333775|"     This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with     docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast     cancer who are candidates for taxane-based chemotherapy but who have not received prior     chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the     target sample size is 500+ individuals.   "
190651|NCT00333788|"     The study will continue to assess the safety of certolizumab pegol (CDP870) as well as     examine the evolution of long term efficacy in Crohn's disease patients who completed study     C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct     cost parameters.   "
190652|NCT00333801|"     To study the impact of Individual Placement and Support (IPS) supported employment (SE)     compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with     posttraumatic stress disorder (PTSD).   "
190653|NCT00333814|"     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone     for the treatment of non-infectious intermediate or posterior uveitis.   "
190654|NCT00333827|"     The purpose of this study is to determine effect of cell therapy in patients with severe     dilated cardiomyopathy   "
190655|NCT00333840|"     The purpose of this study is to evaluate and compare the side effects and anti-leukemic     benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid     leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to     receive either interferon plus Ara-C or imatinib as initial treatment.   "
190656|NCT00333853|"     Insulin therapy requires monitoring and frequent review of glucose levels to optimize dosing.     Effective presentation and data analysis are essential. We examined HbA1c changes using the     OneTouch(R) UltraSmart(R) System (Test Group), an integrated glucose meter and electronic     logbook, compared to established meters with paper logbooks (Control Group).   "
190657|NCT00333866|"     This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the     efficacy and safety of pregabalin in patients with fibromyalgia.   "
190658|NCT00333879|"     This is a two-year proof-of-concept study to evaluate a new Virtual Reality (VR)     holographic sound system for use as an audiological Orientation and Mobility (O&M) training     tool   "
190659|NCT00333892|"     To further investigate differences in the immunologic function of various lymphocyte subsets     in HIV-infected patients who are treated early in their infection and during the chronic     phase of the infection. Studies will also be done to further delineate the various     antigen-specific and innate immune responses including characterization of soluble factors     associated with primary HIV infection.   "
190660|NCT00333905|"     The purpose of this study is to determine if reducing blood flow to an exercising muscle     during exercise training will enhance the training effect on that muscle in people who have     limited exercise because of congestive heart failure   "
190665|NCT00333970|"     The purpose of this study is to determine which variables predict improvement on a cognitive     training task battery, used for patients with schizophrenia, and to determine the proportion     of patients whose performance returns to normal following cognitive training   "
190666|NCT00333983|"     The purpose of this study is to compare 2 training programs using robotic exercise devices to     supervised arm exercises in stroke patients with chronic stable deficits.   "
190667|NCT00333996|"     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone     for the treatment of non-infectious anterior uveitis.   "
190685|NCT00344435|"     This international study will identify genetic factors that may influence the development of     inhibitory antibodies in patients with hemophilia A after treatment with factor VIII.     Bleeding episodes in patients with inhibitors are often more difficult to treat. Previous     research indicates that genetic factors play a role in the development of inhibitors. A     better understanding of the influence of genes in this treatment complication may be helpful     in predicting, treating or preventing inhibitors.      People in families in which one or more members have severe factor VIII deficiency and one or     more have a history of an inhibitor may be eligible for this study. Participants fill out a     form with questions about the person's relationship to other family members taking part in     the study. Those with hemophilia provide a brief medical history, including     hemophilia-related information, inhibitor history and the presence of other conditions such     as hepatitis C and HIV. All participants have a blood sample taken for laboratory and     research tests.   "
190763|NCT00346515|"     Multicenter, prospective, feasibility study designed to demonstrate the performance and     safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive     device during carotid artery percutaneous intervention using the Guidant Acculink carotid     stent in high surgical risk patients.   "
190668|NCT00334009|"     Although clinical risk factors for postoperative development of vasodilatory shock and acute     renal failure have been identified; there is a considerable proportion of patients undergoing     cardiac surgery where this syndrome cannot be predicted.      We sought to investigate the impact of Catecholamine-O-Methyltransferase (COMT) polymorphism     on the duration of vasodilatory shock and other important clinical outcomes in cardiac     surgery patients.      COMT is a key enzyme in the degradation of catechols eg. catecholamines. 25% of the     population have a low activity (L/L) of this enzyme. Sustained low COMT activity is     associated with an altered metabolic profile of catecholamines and their degradation     products.      The process of cardiopulmonary bypass (CPB)over-activates some of the same mechanisms the     body uses to defend itself against severe infection. One of the main overactive defence     mechanisms is the release of highly toxic compounds derived from oxygen - a process called     'oxidative-stress'. Increased reactive oxygen species (ROS) generation can lead to     inactivation of biologic mediators, including catecholamines. It is well established that     some radicals autoxidizes catecholamines, including DA, NE, and epinephrine and contribute     significantly to vasoplegia.      As part of this study, we will take six 2.7mL samples of blood, collected before, and after     the operation, from the arterial catheter routinely inserted in every patient. This blood     will be used to measure COMT genotype, the concentration of plasma-catecholamines as well as     marker of oxidative stress.      Our plan is to enrol patients undergoing cardiac surgery if the use of the CPB is planned.   "
190669|NCT00334022|"     In order to better understand the source(s) and the mechanism(s) of HIV persistence and to     potentially lead to further suppression of HIV from viral reservoirs, we propose to examine     the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of     the size of the viral reservoir in infected individuals who are receiving effective antiviral     therapy for extended periods of time (> 5 years).   "
190670|NCT00334035|"     For schizophrenic patients who remained in remission while on maintenance medication, there     may come a point in time when the relative risk for relapse become so low that     discontinuation of therapy can be considered. This study is to investigate whether that point     in time is reached in 12 months following the first episode illness. Moreover, it also aims     to identify other predictors of relapse as well as to evaluate the costs and benefits of     maintenance therapy.   "
190671|NCT00334048|"     Antidepressant medicines sometimes cause sexual side effects. The purpose of this study is to     determine whether the sexual dysfunction sometimes caused by selective serotonin reuptake     inhibitor (SSRI) antidepressant medications can be reversed by treatment with Requip     (ropinirole), a medicine which is used to treat Parkinson's Disease and restless leg     syndrome.   "
190672|NCT00344240|"     The purpose of the project is to better understand how exercise and education will help     mobility and health in older adults with diabetes. The investigators are trying to learn what     type of exercises and classes are needed to help older adults stay active. This knowledge     will eventually prove useful in helping patients and doctors understand what is needed to     keep older adults with Type 2 diabetes as healthy as possible.   "
190673|NCT00344253|"     The purpose of this study is to investigate if interferon beta is superior to the standard     treatment with Methotrexate for the treatment of intermediate uveitis and macular edema.   "
190674|NCT00344266|"     This study will look at gene expression (whether particular sets of genes are activated     [turned on] or deactivated [turned off]) in overweight people as compared to     non-overweight individuals. It will also investigate the potential role of inflammatory and     protective substances that are produced naturally by the body within fat tissue. Findings     from the study may lead to the development of ways to predict who will respond best to diet     therapy.      Healthy individuals between 25 and 45 years of age may be eligible for this study. Overweight     subjects must have a BMI of 25 to 40, and non-overweight control subjects a BMI of 19 to     24.9. Candidates are screened with a medical history, physical examination, blood tests and     electrocardiogram (EKG). They are instructed to record their dietary intake for a 3-day     period and to collect their urine for a 24-hour interval.      Participants have their food records reviewed a week after the screening visit. They are then     scheduled for an overnight admission to the Clinical Center. Non-overweight subjects have one     or two inpatient stays; overweight subjects have six inpatient stays plus frequent nutrition     counseling sessions. During the 2-day hospital admissions, the following studies are     performed:        -  DEXA scan to determine the percentage of body fat tissue. The subject lies on a table          for about 15 to 60 minutes while the body composition is measured with very low-dose          x-rays.        -  Single-slice CT scan to compare the amount of fat tissue under the skin with that in the          abdomen. The subject lies on a table for about 5 to 10 minutes while the CT scanner          measures body composition with very low-dose x-rays.        -  Subcutaneous fat microdialysis to investigate how weight loss affects the activity of          fat tissue. A small tube (catheter) is placed into the fat tissue under the skin of the          abdomen after numbing the skin with a local anesthetic. Fluid samples are collected          through the tube. The procedure lasts overnight. In five non-overweight controls, a          small amount of a substance called leukotriene B4 is put into their fat tissue to help          adjust the instruments used in the study.        -  Air-displacement plethysmography to measure body composition. Subjects wear          close-fitting clothing and enter a small capsule called a Bod-Pod. They breathe normally          in the capsule while their body fat composition is studied.        -  Blood tests. Blood samples are drawn to analyze thyroid hormones, lipids, glucose,          electrolytes, clotting factors, kidney function, red cells and DNA.        -  Euglycemic-hyperinsulinemic clamp to measure the effects of insulin in the body and to          derive an index of insulin-sensitivity. Catheters are placed in a vein in an arm and in          a vein in the hand on the other side of the body. Insulin and glucose are infused          through the catheter in the arm, and blood samples are drawn from the catheter in the          hand every 5 minutes to measure glucose levels. The test lasts about 2 hours.        -  Subcutaneous fat biopsy to find out how weight loss affects fat tissue characteristics,          gene regulation and the ability to store glucose. A small sample of fat tissue is          obtained from the skin of the abdomen after numbing the area with an anesthetic.        -  Nutrition counseling for overweight subjects. A nutritionist reviews the food record and          designs a personalized diet for each participant.        -  Weight loss intervention for overweight subjects. In addition to individual nutritional          counseling, group sessions are provided every 2 weeks during the first 3 months of the          study and then every month.   "
190675|NCT00344279|"     This study, sponsored by the National Institutes of Health and the Tuberculosis Research     Centre and YRG-Care in Chennai, India, will examine how treatment of lymphatic filariasis in     HIV-infected patients influences the amount of HIV virus in the blood and the progression of     HIV infection to AIDS. Filarial infections are common in Chennai, and it is important to     understand whether treatment of filariasis affects the course of HIV disease. The information     gained from this study could be used to modify treatments for people both with HIV and     filarial infections.      Patients 18 years of age and older who are receiving treatment for HIV infection at the     Government Hospital HIV clinic or YRG-Care may be eligible for this study. Two groups of     patients will be recruited - patients with both HIV and filarial infections, and patients who     have HIV infection alone, without filariasis. Candidates are screened with a medical history     and review of medical records, physical examination, and blood and stool tests. Women have a     urine pregnancy test.      Within one month of screening, all participants receive a single dose of diethylcarbamazine     and albendazole, a drug regimen commonly used to treat filarial infection. Patients are     followed closely for the first 2 weeks after treatment to check for side effects. They are     then seen at 1, 3, 6 and 12 months after the treatment dose for a physical examination and     blood test.   "
190676|NCT00344292|"     Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls     of arteries. New strategies are needed to prevent and treat atherosclerosis. The purpose of     this study is to analyze the DNA of participants in two ongoing studies to identify genetic     variations responsible for the development of atherosclerosis.   "
190677|NCT00344305|"     Open label, single arm, multicenter study of the shedding and safety of a single dose of     trivalent, influenza virus vaccine live, intranasal in children 6 to < 60 months of age, with     28-day shedding follow-up and 180-day safety follow-up.   "
190678|NCT00344318|"     This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals'     pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib     and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of     age.      The study has 2 groups.        -  One group of subjects will receive a 3-dose primary vaccination with the GSK          Biologicals' pneumococcal conjugate vaccine (three different lots will be used and          randomly allocated).        -  The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.      All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol     posting deals with objectives & outcome measures of the primary study. The objectives &     outcome measures of the Booster study are presented in a separate protocol posting (NCT     number =00547248).   "
190679|NCT00344331|"     This study will evaluate clinical and laboratory tests that might be useful in determining if     an investigational drug can slow the progression of Niemann-Pick Disease, Type C (NPC), a     genetic disorder that results in progressive loss of nervous system function. The study will:     1) look for a clinical or biochemical marker that can be used as a measure of response to     treatment, and 2) define the rate of progression of biochemical marker abnormalities in a     group of NPC patients who will later be invited to enroll in a treatment trial.      Patients of any age with NPC may be eligible for this study. Participants undergo the     following procedures every 6 months during 4- to 5-day admissions at the NIH Clinical Center.        -  Medical evaluation, including medical history, physical exam, neurological exam,          neuropsychometric evaluation, and blood and urine tests.        -  Lumbar puncture (spinal tap): A sample of cerebrospinal fluid (CSF), the fluid that          bathes the brain and spinal cord, is obtained for study. After administration of a local          anesthetic, a small needle is inserted in the space between the bones in the lower back          where the CSF circulates below the spinal cord. A small amount of fluid is collected          through the needle.        -  Eye exam and eye movement study: The pupils of the eye are dilated to examine the          structures of the eyes. For the eye movement study a special contact lens is placed on          the eye and the patient looks at a series of target light spots moving on a screen.        -  Hearing tests.        -  Electroretinography (in patients who can cooperate with the test) to measure the          function of the retina. Before the test, the patient's pupils are dilated and an          electrode (small silver disk) is taped to the forehead. The patient sits in a dark room          for 30 minutes and then a special contact lens is placed on one eye after it has been          numbed with drops. The contact lens senses small electrical signals generated by the          retina when lights flash. During the ERG recording, the eye is stimulated with flashes          of light projected inside a hollow sphere. After the test, a full eye exam is done and          photographs of the retina are taken.        -  Magnetic resonance imaging (MRI): This test uses a magnetic field and radio waves to          produce images of the brain and obtain information about brain chemicals. The patient          lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing          earplugs to muffle loud knocking and thumping sounds that occur during the scanning          process. Patients who cannot remain still in the scanner may be sedated for the test.        -  Psychometric testing: Patients complete questionnaires.        -  Photographs of the patient may be taken for use in teaching sessions or scientific          presentations or publications, with the patient's consent. Patients may be recognizable,          but are not identified by name.        -  Pregnancy test in all female patients over 10 years of age at the beginning of each          admission to the Clinical Center.   "
190680|NCT00344344|"     A Pilot Study to Evaluate the Efficacy of Refined Methods to Mitigate Indoor Allergens in     North Carolina and Boston, Massachusetts Homes   "
190681|NCT00344370|"     This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind     extension study for patients who participated in study NK-104-305.   "
190686|NCT00344448|"     This study will examine the effect of the drug Raptiva (efalizumab) in patients with     Sjögren's syndrome (SS), an autoimmune disease affecting the glands producing saliva & tears.     The cause of SS is not known, but inflammation plays an important role. Raptiva is approved     by the Food and Drug Administration to treat psoriasis, an inflammatory skin disease.     Patients 18 years of age & older with SS may be eligible for this study. Candidates are     screened with a history & physical examination, chest x-ray, and oral & eye examinations.      Participants are randomly assigned to receive either Raptiva or placebo (an inactive     substance that looks like Raptiva) for the first 3 months of the study. For the next 3     months, all participants receive Raptiva. Both Raptiva & placebo are injected under the skin     once a week. Evaluation during treatment & for 2 months after treatment as follows:      Full comprehensive evaluations (beginning of the study, at weeks 13 & 25 and 2 months after     treatment ends):        -  Physical examination & blood draw.        -  Saliva collection done in two ways: 1) suctions cups connected to collection tubes are          placed over the salivary gland ducts in the mouth and under the tongue; and 2) a          sour-tasting liquid is applied to the top & sides of the tongue at 30-second intervals          to stimulate saliva production.        -  Eye exam for tear gland function.        -  Questionnaires about mouth & eye dryness, energy level and overall well-being.        -  Lip biopsy (screening & week 13 visits only). A few minor salivary glands are removed          for examination under a microscope. The lower lip is numbed, a small cut is made on the          inside of the lip, and several glands are removed. The cut is closed with a few stitches          that are removed after 5 to 7 days.        -  Magnetic resonance imaging of the parotid glands (salivary glands near the ear) at weeks          1, 13 and 25. The patient lies on a stretcher that is moved into the scanner (a metal          cylinder containing a strong magnetic field). The head is held in place during the scan.          The study lasts about 90 minutes.        -  Short evaluations at weeks 3, 5, 9, 15, 17, 21 and 1 month after treatment ends.        -  Medical history & physical examination, blood draw, evaluation for changes in symptoms          and side effects, review of current medications at weeks 3, 9, 15 and 21.        -  Laboratory tests, evaluation for changes in symptoms and side effects, review of current          medications, saliva collection without the sour liquid and short evaluation of tear          production at weeks 5 and 17.        -  Blood tests at week 29   "
190687|NCT00344461|"     Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and     Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy     will be enrolled. Study will include a pharmacokinetic substudy to evaluate the interaction     of FTC and Nevirapine. Truvada may be used.   "
190688|NCT00344474|"     Personality targeted cognitive behavioural interventions have been shown to be effective in     reducing alcohol and drug misuse in adult substance abusers (Conrod et al., 2000) and     adolescent drinkers (Conrod et al, in press). As these interventions target personality     traits linked to risk for addictive and non-addictive mental disorders, the aim of this study     is to examine the extent to which this approach can prevent and/or reduce alcohol and drug     misuse as well as have an impact on the onset or severity of emotional and behavioural     problems in young people.   "
190689|NCT00344487|"     To explore the hypothesis that the use of Lopinavir/ritonavir will be associated with     improved CD4 immune reconstitution in volunteers who fail to demonstrate a significant CD4     cell increase (while on their first antiretroviral treatment regimen) despite sustained viral     suppression by a non-Lopinavir/ritonavir-containing regimen   "
190690|NCT00344500|"     This program aims to help Veterans who take antipsychotic medications lose weight. The     investigators use a program based on the American Diabetes Association's Diabetes Prevention     Program, and the investigators have modified it to fit the lifestyles of people with mental     illness. All participants are educated about nutrition and cutting down fat intake, how and     when to exercise, and the causes of diabetes and how to prevent it. Participants must be     Veterans who live within one hour of the West Los Angeles VA hospital.   "
190691|NCT00344513|"     This program is designed to improve medical care and education of hospitalized patients with     heart failure and accelerate the initiation of evidence-based heart failure guideline     recommended therapies by administering them before hospital discharge. A registry component     focusing on admission to discharge and 60- to 90-day follow-up is designed to evaluate the     demographic, pathophysiologic, clinical, treatment, and outcome characteristics of patients     hospitalized with heart failure.   "
190692|NCT00344526|"     AL amyloidosis is caused by a clonal plasma cell dyscrasia and characterized by progressive     deposition of amyloid fibrils derived from monoclonal Ig light chains, leading to multisystem     organ failure and death. The prognosis for AL amyloidosis with conventional treatment remains     poor, Autologous stem cell transplantation (ASCT) for AL amyloidosis produces high     hematologic and organ responses. However, treatment-related mortality remains high and     reported series are subject to selection bias.   "
190693|NCT00344539|"     The purpose of this study is to test an experimental malaria vaccine in about 75 healthy     adults, 18-45 years of age. The study will also test an experimental adjuvant which is a     material added to a vaccine to help the body make more defense cells. The body's immune     response (response to foreign substances) and the safety of the vaccine will be tested. All     subjects will receive 3 doses of vaccine on days 0, 28, and 56 and doses may increase during     the study. Participation in the study is expected to be up to 323 days and includes 16     visits. Study procedures include medical history, physical exams, urine and blood testing.   "
190697|NCT00344591|"     This study will evaluate the effectiveness of Structured Ecosystems Therapy (SET), a form of     therapy that includes family and caregivers, at reducing HIV transmission risk behaviors and     improving treatment adherence in HIV infected men newly released from prison.   "
190698|NCT00345631|"     The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device     is more effective than standard manual compression at sealing the puncture made in the     femoral artery following a cardiac or peripheral diagnostic or interventional procedure while     maintaining the same level of safety.   "
190732|NCT00346086|"     Various chemical modifications of allergens have been attempted to enhance efficacy, improve     safety, and foster compliance with IT. These approaches have been unsuccessful - in that the     allergenicity and immunogenicity have either decreased, or increased in tandem, with no     resultant efficacy: safety benefit ratio. This study utilizes an adjuvant approach in which     synthetic immunostimulatory DNA is conjugated to ragweed allergen in an attempt to modulate     both the clinical and immunologic allergic response to ragweed exposure in ragweed-allergic     patients with seasonal rhinitis.   "
190764|NCT00346528|"     To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus     for use during cataract surgery in Pediatric patients.   "
190699|NCT00345644|"     The primary objective of this study is to compare risedronate 35 mg and placebo with respect     to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in     osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative     computed tomography (3D pQCT).      The secondary objectives are to compare the percent change from Screening/Baseline between     the 2 treatment groups for the following measurements:        -  Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total          proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;        -  3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12,          and 24 months; and        -  Bone turnover markers (BTMs) of:             -  fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen               (CTX 1);             -  serum aminoterminal propeptide of type 1 procollagen (PINP); and             -  urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.   "
190700|NCT00345657|"     The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin     in patients receiving standard care who are not at LDL goal per ATP III guidelines.   "
190701|NCT00345670|"     This is a randomized, double-blind, placebo-controlled, dose-escalation, Phase 1,     multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding     of MEDI-534 in healthy children 1-9 years of age who are seropositive for respiratory     syncytial virus (RSV) and parainfluenza virus type 3 (PIV3) at screening.   "
190702|NCT00345683|"     The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a     control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.      This protocol posting deals with objectives & outcome measures of the booster phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT00345579).      No new recruitment will take place during this booster phase of the study. The Protocol     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
190703|NCT00345696|"     The purpose of this study is to determinate progression free survival after 9 months of     treatment.   "
190704|NCT00345709|"     Long-Term Objectives:        -  To establish an ongoing national research registry of epidemiologic, clinical and          pathologic data on low grade and low malignant potential (LMP) ovarian cancer patients          in UTMDACC's Department of Gynecologic Oncology for research purposes.        -  To create a bank of low grade and LMP ovarian cancer tumor blocks for study of the          molecular and histopathologic differences among low grade ovarian cancer, ovarian LMP          tumors and high grade ovarian cancer.        -  To specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer          patients.        -  To identify potential precursors of low grade and LMP ovarian cancer.        -  To assess treatment patterns to guide management of these diseases.        -  To collect quality of life and health outcomes data on these patients.        -  To achieve a fundamental understanding of low grade and LMP ovarian cancer that will          inform prevention and screening efforts, motivate development of improved treatments and          eventually result in a cure.      The short-term objectives are:        -  To detail procedures for potential registrant identification and recruitment.        -  To create a demographic and health history questionnaire for potential registrants.        -  To begin aggregating low grade and low malignant potential ovarian tumor blocks.        -  To specify a timeline for the development of all other aspects of the Registry.   "
190705|NCT00345722|"     The purpose of this study is to determine whether addition of strawberries to a dietary     portfolio of cholesterol-lowering foods will improve compliance and so increase the     effectiveness of the dietary portfolio in lowering cholesterol and improving cardiovascular     risk factors.   "
190706|NCT00345735|"     Primary Objective:      To demonstrate the efficacy of intranasal fentanyl in the treatment of breakthrough pain     (BTP) in cancer patients.      Secondary Objective:      To explore the relationship between the response to the fentanyl dose and the stable     background pain opioid dose.   "
190707|NCT00345748|"     The purpose of this study is to demonstrate that Abatacept combined with Methotrexate will     demonstrate a dose response efficacy in Japanese subjects with active Rheumatoid Arthritis     similar to the dose response efficacy previously observed in the International clinical     trials.   "
190708|NCT00345761|"     This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000     mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2     intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with     advanced and/or metastatic colorectal cancer.   "
190709|NCT00345774|"     This study is being conducted to see if PRX-08066 can lower pulmonary artery pressures in     patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.   "
190710|NCT00345787|"     The primary objective of this study is to evaluate the efficacy and safety of BTDS compared     to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee.   "
190712|NCT00345813|"     RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients     planning to undergo surgery.      PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works     compared to a placebo in treating patients undergoing surgery for localized prostate cancer.   "
190713|NCT00345826|"     RATIONALE: Dasatinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase I trial is studying the side effects of dasatinib in treating patients     with chronic myelogenous leukemia or acute lymphoblastic leukemia.   "
190714|NCT00345839|"     The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or     Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD)     patients with secondary hyperparathyroidism (HPT) who are receiving dialysis.   "
190715|NCT00345852|"     This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser     photocoagulation [SFLP]) in patients with severe twin to twin transfusion syndrome.   "
190994|NCT00339092|"     This study will evaluate the effectiveness of a modified directly observed therapy program in     increasing antiretroviral therapy adherence in poor, HIV-infected residents of urban     communities.   "
190716|NCT00345865|"     RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer     growth in different ways. Some block the ability of cancer cells to grow and spread. Others     find cancer cells and help kill them or carry cancer-killing substances to them. Giving     colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone     marrow to the blood so they can be collected and stored for peripheral stem cell transplant.     Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body     irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells     are then returned to the patient to replace the blood-forming cells that were destroyed by     the chemotherapy and radiation therapy. More radiation therapy is given after transplant to     kill any remaining cancer cells.      PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant     works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.   "
190717|NCT00345878|"     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.     The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to     cervical cancer in women. This study will evaluate the immunogenicity and safety of the     HPV-16/18 L1 VLP AS04 vaccine.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
190718|NCT00345891|"     The purpose of this study is to evaluate the impact of delivering a coping-focused     intervention as an adjunct to a self-help program to promote smoking cessation among     relatives of lung cancer patients.   "
190719|NCT00345904|"     Vaccination is currently the most effective mean of controlling influenza and preventing its     complications and mortality in persons at risk. Because of the variable nature of influenza     viruses, the composition of influenza vaccines changes almost every year, to target the 3     main circulating strains. Each year the influenza vaccine formulation may thus be different     and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine     formulated from the three annual circulating strains are similar to what was observed during     the previous years.      This study is designed to test the immunogenicity and reactogenicity of the Fluarix™ vaccine     containing the influenza strains recommended for the 2006-2007 season.   "
190720|NCT00345917|"     The long-term goal is to show that retinal transplantation can help to prevent blindness and     to restore eyesight in patients with the inherited disease retinitis pigmentosa.   "
190721|NCT00345930|"     The purpose of this study is to identify individuals who have suffered a liver injury arising     as an idiosyncratic reaction to a prescription drug or a complementary and alternative     medicine. Recently added acute cases enrollment that meets criteria to the protocol. Also     added Fibroscans to the protocol that will be completed at baseline and follow-up on chronic     subjects.   "
190722|NCT00345943|"     The aim of this project is to use both multimodal MRI and behavioral measures to investigate     how changes in frontostriatal neural systems contribute to the development and persistence of     Bulimia Nervosa (BN). Findings from this study will have wide-ranging importance for our     understanding of the development and treatment of BN.   "
190723|NCT00345956|"     To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when     co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study     will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo   "
190724|NCT00345969|"     The purpose of this study is to determine, in older men with physical frailty, whether     exercise training combined with testosterone replacement therapy can improve physical     function, muscle mass, bone density,and quality of life, to a greater degree than exercise     training alone.   "
190725|NCT00345982|"     The purpose of the study is to determine whether addition of sertindole to clozapine     treatment can improve psychosis or the metabolic side-effects of clozapine in patients with     treatment-resistant schizophrenia.   "
190726|NCT00346008|"     RATIONALE: Studying the genes expressed in samples of blood from patients with cancer and     their family members may help doctors identify biomarkers related to cancer.      PURPOSE: This clinical trial is studying genes to identify melanoma in patients in Iceland     and their family members.   "
190727|NCT00346021|"     Purpose of the project is to develop a school-based intervention aimed at increasing hat use     when children are outside at home and at school. The intervention is targeted to fourth grade     children in Hillsborough County, Florida and is based on Theory of Reasoned Action and     Planned Behavior. It is structured to accomplish the following goals: (a) increase sun     protection knowledge of children in regards to hat use,(b) foster more positive attitudes in     regard to wearing hats,(c) change the subjective norms of wearing hats (d) target persons     that children perceive as controlling their behavior of wearing hats(parents,teachers) and     increase the use of hats when children are outdoors at school(primary outcome) and when     outdoors at times other than school(secondary outcome).   "
190728|NCT00346034|"     The main purpose of this protocol is to evaluate the long-term safety of pregabalin in     patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive     open-label pregabalin therapy.   "
190729|NCT00346047|"     The primary objective of this study is to evaluate the efficacy and safety of BTDS compared     to placebo in subjects with moderate to severe low back pain.   "
190730|NCT00346060|"     The long-term goal is to show that retinal transplantation can help to prevent blindness and     to restore eyesight in patients with dry age related macular degeneration.   "
190731|NCT00346073|"     GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug     Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has     recently issued provisional recommendations for universal adult Tdap vaccination. The current     study will provide pivotal data in support of extending the age range for Boostrix vaccine to     include adults 19-64 years of age.   "
190761|NCT00346489|"     A clinical trial to establish the long term response of using intraoperative 5-fluorouracil     (5-FU) versus mitomycin C (MMC) in trabeculectomy glaucoma surgery. Antiproliferative agents     such as 5-fluorouracil and Mitomycin C have been used extensively in trabeculectomy surgery     to improve the success of the surgery and prevent further visual loss and blindness in     glaucoma patients.   "
190733|NCT00346099|"     Panitumumab is a monoclonal antibody. It works by attaching to a protein called epidermal     growth factor receptor found on normal and cancer cells. When panitumumab attaches, it blocks     another protein called epidermal growth factor (EGF) from attaching to the cell. This is     important because, when EGF is blocked, a cell's growth slows down or stops. Panitumumab may     also help radiation therapy work. Also because panitumumab is a fully-human antibody, it may     be less toxic than other monoclonal antibodies made to block the EGF receptor. Chemotherapy,     such as capecitabine and oxaliplatin, works to kill cancer cells directly. Capecitabine given     during radiation helps radiation therapy work better. This study is being done to learn how     rectal cancer tumors that are not removed surgically respond to treatment with panitumumab     and chemotherapy given before radiation therapy begins followed by treatment with panitumumab     and capecitabine given with radiation therapy.   "
190734|NCT00346112|"     RELAX-ICD Trial/Research Study; Quality of Life/Protocol No.P-KARE-01: A 3-month outpatient     rehabilitation therapy and psychological counselling including informative talks with     conventional therapy, by a cardiologist or general practitioner after implantation of an     internal cardioverter defibrillator (ICD) in adult patients, whereby the effects of three     different strategies are compared. Study hypothesis: the rehabilitation programme will be     beneficial in the management of any psychological problems possibly as a result from the     intervention, and will help to overcome anxiety, and contribute to improved quality of life.   "
190735|NCT00346125|"     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) scan and     computated tomography (CT) scan, may help doctors predict a patient's response to treatment     and may help plan the best treatment. Drugs used in chemotherapy, such as doxorubicin and     ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving chemotherapy before surgery may make the     tumor smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This clinical trial is studying how well PET scan combined with CT scan predicts     response in patients undergoing chemotherapy and surgery for soft tissue sarcoma.   "
190736|NCT00346138|"     The objectives of this study are to compare the visual and refractive outcomes of deep     lamellar endothelial keratoplasty (DLEK) with penetrating keratoplasty as treatment for     certain cases of corneal edema due to endothelial decompensation. Additionally, data will be     collected to compare corneal shape, corneal thickness, endothelial cell density, keratocyte     density, corneal sensitivity, light scatter, and subjective visual function between the two     procedures.   "
190737|NCT00346151|"     Belatacept is an experimental medication shown in clinical trials to have immune system     suppression properties in people who have had renal (e.g., kidney) transplants. This study     will determine whether a combination of anti-rejection drugs, including belatacept, can     prevent the rejection of a first-time, non-human leukocyte antigen (HLA) identical renal     transplant and allow patients to be safely withdrawn from anti-rejection therapy one year     post-transplant.   "
190738|NCT00346164|"     This phase III trial is studying observation to see how well a risk based treatment strategy     works in patients with soft tissue sarcoma. In the study, patients are assigned to receive     surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes,     after surgery, the tumor may not need additional treatment until it progresses. In this case,     observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells.     Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller     and reduce the amount of normal tissue that needs to be removed. Giving these treatments     after surgery may kill any tumor cells that remain after surgery.   "
190739|NCT00346177|"     The purpose of this study is to determine if cell therapy with your own cells (autologous     cells) delivered with a catheter to regions of the heart with poor blood flow will be safe     and if it will improve your ejection fraction and heart failure symptoms.   "
190740|NCT00346190|"     To determine whether administration of Alendronate early is more effective than late in the     prevention of osteoporosis following a hip fracture   "
190741|NCT00346216|"     To answer the question of overall benefit: risk of celecoxib when compared to two most     commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs)     in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or     rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited.     The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each     treatment group will be assessed accordingly.   "
190757|NCT00346437|"     The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4     is effective in improving exercise capacity measured by exercise treadmill testing, angina     functional class, patient symptoms, quality of life, and cardiovascular outcomes. Two doses     will be studied, 2.87 x 10(8) and 2.87 x 10(9) viral particles, to evaluate the dose-response     of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.   "
190742|NCT00346229|"     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above     normal body temperature. Giving temperature-sensitive liposomal doxorubicin together with     hyperthermia may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of     temperature-sensitive liposomal doxorubicin when given together with hyperthermia in treating     women with locally recurrent breast cancer.   "
190743|NCT00346242|"     The evaluation of efficacy is performed by laboratory monitoring of bone density and     resorption markers and clinical monitoring of bone density improvement. This is a     prospective, randomized, parallel group, single blind study of one year treatment with     zoledronic acid every 6 months as compared to one year treatment with zoledronic acid every 3     months and to placebo every 3 months in patients with hemoglobin syndromes and risk of     skeletal complications.   "
190744|NCT00346255|"     RATIONALE: Monoclonal antibodies, such as BB-10901, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them.      PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in     treating patients with relapsed and/or refractory multiple myeloma.   "
190745|NCT00346268|"     The primary objective of this study is to demonstrate the opioid-sparing efficacy of     parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the     24 hours after the end of surgery.   "
190995|NCT00339105|"     The purpose of the study is to assess the usefulness of high Frequency mid-QRS analysis in     identifying the ischemic origin of patients presenting to the Emergency Room (ER)with Chest     pain.   "
190746|NCT00346281|"     This is the first study investigating the safety of 32P BioSilicon in patients with     advanced,unresectable pancreatic cancer who are also receiving standard intravenous     gemcitabine chemotherapy. The secondary aims of the study will assess the implantation     procedure, localisation of 32P BioSilicon, tumour response and survival parameters.      Tumours targetted with 32P BioSilicon is hypothesized to show a reduction in tumour volume     and with the low radioactivity dose that is delivered intratumourally, the incidence of side     effects associated with the treatment is expected to be low. Prologation of survival and     improved quality of life could be favourable outcomes of the investigational product.   "
190747|NCT00346294|"     An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™     Auto-injector in RA subjects.   "
190748|NCT00346320|"     RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may     kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This phase II trial is studying how well radiation therapy works in treating     patients with stage I or stage II non-small cell lung cancer that cannot be removed by     surgery.   "
190749|NCT00346333|"     The purpose of this trial is to determine whether lutein in addition to vitamin A will slow     the course of retinitis pigmentosa.   "
190750|NCT00346346|"     This study will examine the immune response to the malaria parasite at the cellular level to     better understand why people achieve natural immunity to the parasite only after multiple     infections and why immunity diminishes rapidly in the absence of ongoing infection. The     results of this study may provide insight into whether and how natural immunity can be     improved upon by vaccination.      Healthy people 2-4 and 18-25 years of age who live in the village of Kambila, Mali, may be     eligible for this 1-year study. Participants have a small blood sample collected from a vein     in the arm and also from two finger pricks at the beginning of the study, then every 2 months     for 6 months and at the end of the study (for a total of five samples). People who become ill     with malaria are evaluated and treated by a physician. Those recovering from their first     episode of malaria during the study period have another blood sample collection and two     finger pricks (bringing to six the total number of samples collected).   "
190751|NCT00346359|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor     peripheral stem cell transplant helps stop the growth of abnormal and cancer cells. It also     stops the patient's immune system from rejecting the donor's stem cells. The donated stem     cells may replace the patient's immune system and help destroy any remaining abnormal or     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can     also make an immune response against the body's normal cells. Giving antithymocyte globulin,     tacrolimus, and methotrexate before or after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan     followed by donor peripheral stem cell transplant and antithymocyte globulin, tacrolimus, and     methotrexate works in treating patients with myeloid cancer.   "
190752|NCT00346372|"     During regularly scheduled appointments, Optical Coherence Tomography (OCT) is performed on     consented subjects. The OCT is a new type of camera that takes very detailed pictures inside     of the eye and deeper into eye tissues. Optical Coherence Tomography imaging of intraocular     tumors may lead to improved diagnosis and monitoring of tumors within the eye.   "
190753|NCT00346385|"     RATIONALE: Monoclonal antibodies, such as BB-10901, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them.      PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in     treating patients with relapsed or refractory solid tumors.   "
190754|NCT00346398|"     The purpose of this study is to determine whether early childhood exposure to common     allergens (substances that can trigger allergies and asthma) can prevent the development of     asthma in children at high risk for developing the disease.   "
190755|NCT00346411|"     This research is being done to help us learn about how different factors related to treatment     affect rheumatoid arthritis (RA). This is not a treatment study. We will follow the patient     for one year as he or she receives usual treatment from his or her rheumatologist. Up to 360     adults with RA may join this study.   "
190756|NCT00346424|"     The purpose of the study is to compare the safety and effectiveness of alfimeprase to a     placebo in restoring function of occluded central catheters.   "
190758|NCT00346450|"     To evaluate the use of cultivated conjunctival epithelial equivalents for the treatment of     ocular diseases   "
190759|NCT00346463|"     Growth retardation in utero may be caused by uteroplacental vascular insufficiency. When     Doppler ultrasound studies of the umbilical artery are abnormal pathological intrauterine     growth restriction (IUGR) can be diagnosed. IUGR fetuses have a higher mortality and     morbidity, both perinatally and on the longer term. This is probably due to chronic     malnourishment and hypoxia due to placental insufficiency. This placental dysfunction causes     generation of harmful free oxygen radicals in the fetus. The IUGR fetus has a diminished     antioxidative capacity which means these free radicals cannot be buffered sufficiently. This     leads to fetal oxidative stress.      Previous studies have shown that allopurinol can inhibit the cascades that lead to generation     of free radicals. High dosed allopurinol also scavenges radicals and binds free iron without     adverse effects on the fetus or mother.      As IUGR is associated with placental insufficiency and excessive production of free radicals     we hypothesize that antenatal allopurinol administration could lead to a decrease in     oxidative stress in the mother and fetus and subsequent improvement of the maternal and/or     neonatal outcome.   "
190760|NCT00346476|"     The purpose of this study is to determine the number of people infected with tuberculosis     (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of     TB and HIV. This study will also examine the genetics of TB and the relationships among     active TB infection, new HIV infections, and HIV disease progression.   "
190765|NCT00346541|"     Glaucoma, an optic neuropathy characterized by progressive visual field loss, is the leading     cause of irreversible blindness worldwide. The condition has a substantial heritable basis,     as illustrated by the numerous loci and genes identified to date, and the large proportion of     patients having a family history.      Interleukin-1 (Il-1) is an important mediator of inflammation. There are 2 pro-inflammatory     cytokines, Il-1 alpha and Il-1 beta. The genes encoding Il-1 are located within a 430kb     region on chromosome 2q14.2. The role of Il-1 in glaucoma is a subject of recent interest. It     has been shown that Il-1, produced endogenously by glaucomatous cells, inhibits the apoptotic     response to oxidative stress, and Il-1 has also been reported to increase outflow facility by     stimulating the _expression of matrix metalloproteinase enzymes, which in turn reduces extra     cellular resistance. Recently, polymorphisms in Il-1 (particularly +3953T of the Il-1 β) were     found to reduce the risk of primary open angle glaucoma. In this pilot study, we aim to     investigate the role of Il-1 polymorphisms in both normal tension and high pressure glaucoma     in our glaucoma patients. Both open and closed angle glaucoma will be studied. This is a     pilot study of the role of immune system related polymorphisms and depending on the results,     we may embark on a larger investigation of other immune genes in glaucoma   "
190766|NCT00346554|"     The goal for COPD patients in pulmonary rehabilitation programs is to improve the quality of     life. COPD is known to be worse at night as are other respiratory problems such as CHF.     Saturation is known to get worse nocturnally as well. Furthermore, these COPD rehabilitation     patients tend to be older and increasing age is associated with an increase in the incidence     of sleep disorders. We suspect that there is an increase in the incidence of sleep disorders     in COPD patients. We plan to further study these patients using questionnaires. A preliminary     study was done, but the results were not comparable to national statistics. We plan to repeat     the study, only changing the questions to a format comparable to data from the National Sleep     Foundation.   "
190767|NCT00346567|"     The aim of the study is to find short course alternatives to single dose (sd)nevirapine for     the prevention of mother-to-child HIV-transmission with the same or better degree of     transmission protection than sd nevirapine but with less NNRTI resistance development.   "
190768|NCT00346580|"     Sepsis is the leading cause of death in critically ill patients in the United States. It     develops in approximately 750,000 Americans annually, and more than 210,000 of them die.     Despite improvements in supportive treatment, mortality has changed very little, and until     recently, no sepsis-specific treatments were available. Protease inhibitors have seemed to     have an immune benefit that extends beyond their ability to prevent HIV replication. T cells     in those patients treated with protease inhibitors have reduced rates of death than in those     patients not receiving therapy.   "
190769|NCT00346593|"     The primary purpose of this study is to investigate the clinical performance of a new     silicone hydrogel contact lens during continuous wear (up to 30 nights) over a period of 24     months.   "
190770|NCT00346606|"     Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg     (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.      Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.      Primary end point: To evaluate the change in average AM/PM reflective pruritus score from     baseline recorded in the subjects’ diaries during the first two weeks of the treatment.      Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and     levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.   "
190771|NCT00346619|"     Our group has shown that HAART increases the thymic production of naïve T cells in the     healthy adult, thereby boosting the immune system. We propose to investigate the amount of     and length of Nelfinavir therapy necessary to increase those cells in adults. Subjects will     be treated with Nelfinavir, and blood will be sampled at variable times to determine the     immune response in peripheral blood.   "
190772|NCT00346632|"     Non-randomized, open, dose ranging and dose scheduling study of ascending doses of KW-2449 in     subjects with AML, ALL, MDS and CML.   "
190773|NCT00346645|"     The purpose of this study is to determine whether Bortezomib is effective in the treatment of     patients with non-small-cell lung cancer who have not received any prior chemotherapy regimen     for advanced disease.   "
190774|NCT00346658|"     Extreme magnesium deficiency is known to have an impact on the synthesis, secretion and/or     action of calcium regulating hormones. Many older adults are at risk for less severe     magnesium deficiency, since the majority of adults receive less than the Recommended Daily     Allowance of magnesium. We hypothesize that magnesium supplementation will have a beneficial     effect on calcium regulating hormones and markers of bone turnover.   "
190817|NCT00347217|"     Observational study to investigate the use and efficacy of CRESTOR 5 mg in reaching LDL-C     target goals in both statin naïve and statin treated primary and secondary prevention     patients at high risk for a cardiovascular event.   "
190818|NCT00347230|"     To study the effects Intacs intracorneal ring segments(Addition Technology, Inc) insertion in     the treatment of keratoconus   "
190775|NCT00346671|"     Complementary therapies such as Reiki are becoming popular. Reiki is a practice used for     relaxation and pain management that involves physical touch and social contact with a     trained, empathetic practitioner. Unlike many relaxation therapies, Reiki requires no     participation by the patient, a feature that makes Reiki particularly attractive in the     hospital setting, where patients are often extremely anxious, depressed, in pain, or sedated.     Our primary research questions are to determine whether physiological changes are induced     during a Reiki session and whether a Reiki session affects responses to a subsequent acute     stressor. Secondary research questions include assessing which benefits result from placebo     or unique abilities of attuned Reiki practitioners and assessing background characteristics     of recipients that are associated with acceptance and responsiveness. Based on its use to     reduce pain and anxiety, we will study potential mechanisms by which Reiki decreases activity     of the sympathetic nervous system and other stress pathways. Comparison of the responses in a     Reiki group with those in supine-control and sham groups will allow us to gain insights into     mechanisms by which Reiki effects are mediated. Information obtained from the proposed     studies will provide detailed information on physiological pathways affected by Reiki. Should     Reiki decrease stress pathways or reduce physiological responses to stressful situations, it     could be a useful adjunct to traditional medicine and have significant health and economic     benefits.   "
190776|NCT00346684|"     First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in     clinical stage IA using the monoclonal anti-CD20 antibody rituximab   "
191362|NCT00351247|"     To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during     primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct     stenting without the postconditioning.   "
190777|NCT00346697|"     The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in     HIV-infected patients with hypertriglyceridemia. In addition, we, the researchers, will     evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and     inflammation.   "
190778|NCT00346710|"     This research is being done to learn more about patient experiences at the Johns Hopkins     Rheumatology Clinic at Good Samaritan Hospital. We want to learn about the patient, his or     her health and experience with the doctor. Up to 75 patients (21 years and older) who are     seen in this clinic may participate.   "
190779|NCT00346723|"     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of     these vaccines are required to be involved in ongoing clinical trials and to present the     results to the competent authorities each year. The current study is a phase IIIa clinical     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It     is part of the ongoing clinical trial program for Influvac® and will be done to assess the     immunogenicity and safety and tolerability of next season's trivalent influenza subunit     vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects     >= 61 years of age (elderly).   "
190780|NCT00346736|"     Autism is a behaviorally defined, lifelong disorder of the brain, affecting at least 1-2 per     1000 children. There is an increasing trend of autism worldwide. However, to date, there is     still no cure for this devastating childhood disease. Autism is characterized by deficit in     language, social communication and repetitive behavior. It is estimated that the annual cost     of care for autism is $13 billion in USA alone. Children with autism usually have associated     behavioral problems such as aggressiveness, stereotypes, hyperactivity, emotional lability,     and short attention span.      The National Institute of Child Health & Human Development and National Institute of Deafness     & Communication Disorders have jointly founded the Collaborative Programs of Excellence in     Autism. One of the long-term NIH goals is to develop or refine interim treatment strategy and     to develop effective biological, behavioral or alternative treatment strategy for autism.     There is a dire need for early identification and treatment of children with autism.      Acupuncture has been practised in China for 2 millennia. The legal status of acupuncture as a     treatment technique was approved by Food & Drugs Administration in USA (1997). The     therapeutic effect of acupuncture is based on stimulation at specific acupoints resulting in     both local and distant effect via improving signal or modulation of electromagnetic energy.     There had lack of studies of acupuncture in autism. We hope that we can study the efficacy of     acupuncture in autism using clinical measurement. We hope to identify the role of acupuncture     as an adjunctive treatment for autism.   "
190781|NCT00346749|"     This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary     Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will     stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects     who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits.     Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing     tests and will complete diary cards during the study. All study medicines and examinations     will be given at no cost to the study subjects. Both medicines used in this study have been     approved by the US FDA.   "
190782|NCT00346762|"     HIV infected former commercial blood donors (FBDs) in Fuyang, Anhui Province, China were     infected with HIV from a common-source exposure to contaminated blood. The purpose of this     study is to examine the role of host and viral factors in HIV disease progression in this     unique HIV infected population.   "
190783|NCT00346775|"     The objective of this cross-over study is to validate the Preference Module of the EARNS-Q in     adult subjects (>=18 years of age) with Seasonal Allergic Rhinitis (SAR) taking     beclomethasone dipropionate and beclomethasone dipropionate and flunisolide.   "
190784|NCT00346788|"     The purpose of this study is to determine if the observed benefits of minimally invasive     total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be     achieved with standard knee arthroplasty using the subvastus approach.   "
190785|NCT00346801|"     Primary Objectives:        -  To determine the feasibility, activity, and toxicity of a novel regimen using a          concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with          unresectable NSCLC.        -  To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC          treated with irinotecan/cisplatin and concurrent thoracic radiation therapy.        -  To correlate the COX-2 expression and other biomarkers with response to the treatment in          the tumor from a pretreatment biopsy specimen.   "
190786|NCT00346814|"     Purpose:Retinopathy of prematurity (ROP) continues tobe a major cause of blindness in     children. Although ablation of the retina with laser or cryotherapy reduces the incidence of     blindness by suppressing the neovascular phase of ROP the visual outcomes after treatment are     often poor. Vascular endothelial growth factor(VEGF) has an important role in the     pathogenesis of ROP and inhibition of VEGF expression in the neovascular phase might prevent     destructive neovascularization in ROP. The aim of this study is to determine the safety and     efficacy of intravitreal bevacizumab in the treatment of retinopathy of prematurity   "
190787|NCT00346827|"     To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in     subjects with Parkinson's Disease.   "
190788|NCT00346840|"     The primary objective of the study was assessment of the efficacy of four dose reservoirs (25     mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered     for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal     delivery.   "
190805|NCT00347061|"     Primary:      To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients     with lower urinary tract symptoms related to BPH.      Secondary:        -  To provide the information on the efficacy of SL77.0499-10 10mg administered once daily          for one year in patients with lower urinary tract symptoms related to BPH.        -  To document the plasma concentration of SL77.0499-10 after repeated administration of          SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms          related to BPH.   "
190806|NCT00347074|"     A clinical study of keratoconus in Asian Patients and assessment of different topographic     patterns of keratoconus in Asian patients   "
190789|NCT00346853|"     The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP,     fomepizole, Antizol™) inhibits dark adaptation of the eye. In other words, we are testing if     4-MP slows the processing of vitamin A derivatives in the eye. By slowing down these     processes, individuals with Stargardt disease may have better chances of saving their     remaining vision. 4-MP has been shown to slow dark adaptation in animals, and is FDA approved     for human use to treat individuals with methanol or ethylene glycol (antifreeze) poisoning by     shutting down the body's ability to process alcohols. This medication has an excellent safety     profile and has been reported to have no short-term or long-term side effects, as long as     patients refrain from any alcohol while the medication is in the body. A single dose of 4-MP     remains in the body for about 12 hours, and therefore, it may inhibit dark adaptation of your     eyes for up to 12 hours. Studying the effects of 4-MP may lead to effective medical treatment     to save Stargardt patients' vision, and may also have similar effects in other macular     degenerative diseases.   "
190790|NCT00346866|"     The purpose of this study was to evaluate the efficacy of anecortave acetate for depot     suspension (30 mg and 15 mg) plus PDT versus PDT alone with respect to maintenance of visual     acuity in patients with wet AMD.   "
190791|NCT00346879|"     This is a prospective open-label study comparing two dosing regimens of fondaparinux, which     is used to prevent deep vein thrombosis, in morbidly obese volunteers.   "
190792|NCT00346892|"     The primary objective of this study was to demonstrate that co-administering HRV vaccine     with OPV does not induce a significant decrease in poliovirus immune response one month after     the third dose of combined vaccines.      The primary objective was reached if one month after the third dose of polio vaccine, upper     limit of the 95% CI for the difference in Seroprotection rate between the group B and C     pooled and (minus) the group A was below 10% for each polio serotype.   "
190793|NCT00346905|"     The study objective is to assess the long term safety and effectiveness of Enteryx device in     commercial use. The long-term effects beyond one year of treatment with Enteryx have not been     established.   "
190794|NCT00346918|"     The aim of our study is to investigate whether Rapamune used at a low dose (2 mg/d) retards     cyst growth and slows renal functional deterioration in patients with ADPKD.   "
190795|NCT00346931|"     The purpose of the study is to determine whether combined cataract and glaucoma surgery     (phacotrabeculotomy)is more effective in lowering intraocular pressure than cataract surgery     alone in patients with borderline control of intraocular pressure.   "
190796|NCT00346944|"     The aim of the project is to study changes in symptom load after removal of all dental     amalgam restorations in patients with symptoms allegedly related to amalgam.   "
190797|NCT00346957|"     The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg     versus placebo) that is safe and effective for the inhibition of the growth of blood vessels     in the retina in patients with wet AMD.   "
190798|NCT00346970|"     The aim of the present study is to characterize novel mechanisms whereby HDL may exert potent     vasculoprotective effects independent of reverse cholesterol transport, in particular the     effect of HDL on the regulation of the vascular NAD(P)H oxidase enzyme system, a major     vascular source of superoxide, known to be important for endothelial dysfunction. In     addition, the present study will characterize the effect of HDL on endothelial progenitor     cell (EPC) mobilization, nitric oxide production and in vivo regenerative capacity.   "
190799|NCT00346983|"     This research is being conducted to look at the effects of an intraocular drug (pegaptanib,     also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue     in the back of the eye) that often occurs following cataract surgery in patients with     diabetic eye disease. Swelling in the retina can lead to blurry vision, and Macugen may     reduce this swelling. Eyedrops that decrease inflammation also may help to stop some of the     swelling. We are testing this drug (pegaptanib) to see if it can decrease swelling in the     retina and improve vision in patients with diabetes who are having cataract surgery.   "
190800|NCT00346996|"     Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the     occurrence of severe hypoglycaemia during two different insulin regimens are to be     investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised     to receive analogue and human insulin for one year in random order. Outcomes will be number     of episodes of severe hypoglycaemia   "
190819|NCT00347243|"     Purpose:To compare visual performance, total and high order wavefront aberrations (coma,     spherical aberration and other terms) and contrast sensitivity in eyes implanted with one     monofocal aspheric intraocular lens (IOL) and two spherical IOLs (SofPort AO,     Soflex,AcrySof®IQ (40 eyes), AcrySof®Natural and AMO®Sensar)   "
190801|NCT00347009|"     This 36-month open-label study of adefovir dipivoxil investigates the clinical benefits of     the therapy in chronic hepatitis B patients with advanced fibrosis or cirrhosis confirmed     with biopsy. Primary endpoint is histological improvement defined as a decrease of Ishak     Fibrosis Score by one point or more from baseline at Month 36 of adefovir dipivoxil     treatment. Approximately 150 patients will be recruited in study centres in the Asia Pacific     area. The patients are offered 36 months of open label adefovir dipivoxil treatment, with     assessments every three months, after which there is a 6-month post study treatment follow-up     prior to study completion. After the 36 months of study treatment, it is likely that the     patient will benefit from continued treatment with adefovir dipivoxil. If this is the case in     the investigators clinical judgement, the investigator should ensure that a routine     prescription is available in a timely manner, and that no unnecessary interruption in     treatment occurs.   "
190802|NCT00347022|"     This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric     indications.   "
190803|NCT00347035|"     Purpose:      To evaluate the influence of the nonsteroidal anti-inflammatory indomethacin on the     brimonidine intraocular pressure (IOP) lowering effect.      Methods:      A randomized double-masked study was carried out. Patients medicated with timolol maleate     0,5% and needed complementary medication were random allocated into two groups: (a)     brimonidine tartarate 0,15% and indomethacin 1% or (b) brimonidine tartarate and placebo     (balanced saline solution). If patient’s both eyes were eligible, they were allocated to the     same group.      IOP was measured at two weeks, one month and two months after study beginning. The mean IOP     of the eyes was used for analyzes, in the case of two eligible eyes. For statistical analyzes     repeated measures analysis was used.   "
190804|NCT00347048|"     This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in     moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of     12-week open-label efficacy and safety study in responders.   "
190808|NCT00347100|"     Primary:        -  To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline          to endpoint A1c < 7%)      Secondary:        -  To investigate the safety of insulin glargine (in terms of hypoglycaemia, including          symptomatic, non-symptomatic and nocturnal hypoglycaemia)        -  To investigate whether beta cell function is preserved if this therapy is initiated          before 2nd OAD (oral anti-diabetic drug) failure   "
190809|NCT00347113|"     The proposed study has as the main objective to investigate the effect of schistosome and STH     infections and the effect of an anthelminthic intervention on P. falciparum malaria, related     anaemia and malaria antibody responses among school and pre-school children in Mwanza,     Tanzania. The study will include a cross-sectional baseline survey followed by an     anthelminthic intervention trial of two years duration. At baseline, prevalence and intensity     of malaria, schistosome and STH infections and the prevalence of anaemia will be determined     by examination of blood, faecal and urine samples. Spleen and liver size and consistency will     be determined by palpation. P. falciparum specific antibodies will be determined by ELISA.     All children will be treated with a single dose of praziquantel 40mg/kg and albendazole     400mg. Children selected to participate in the intervention trial will be randomized into two     groups, an intervention group of 258 children which will be followed up with albendazole     400mg and praziquantel 40mg/kg at three months interval and a control group of 258 children     which will be followed up with praziquantel 40mg/kg and albendazole 400mg once a year in     accordance with the National Schistosomiasis and Soil-transmitted Helminths Control     Programme. At 12 months and 24 months follow-up, all examinations conducted at baseline     survey will be repeated.   "
190810|NCT00347126|"     Prostaglandin analogs are a leading class of glaucoma drugs with a proven safety and efficacy     for controlling IOP. They include latanoprost, bimatoprost, travoprost and unoprostone.     Recently, the Singapore National Eye Center (SNEC) awarded a tender for prostaglandin     analogues to Alcon, the manufacturer of travoprost. Since then, all subsidized patients     previously treated with latanoprost were systematically switched to travoprost and this     process will continue for the rest of this year. In this study, we propose to prospectively     study the efficacy and safety of switching from latanoprost to travoprost in a large series     of glaucoma patients at SNEC. A total of 372 consecutive patients being switched from     latanoprost to travoprost will be followed up for 12 weeks following the switch. In addition     to intraocular pressure, the safety and tolerability (with particular emphasis on hyperemia)     of travoprost will be examined.   "
190811|NCT00347139|"     In order to obtain information on a wider range of doses of GW642444 (a possible new     medication to treat asthma) than has been previously examined in asthmatic patients, this     current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be     compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar     manner to a study that has already been completed (study number B2C101762) which examined     repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data     from study B2C101762 and will provide confidence (or not) that the desired bronchodilation     can be achieved and maintained without undesirable side effects.   "
190812|NCT00347152|"     The purpose of this study is to determine whether there is any difference in side effects     experienced by individuals with intellectual disorders taking Depakote DR (immediate release     form) when they are switched to the extended release form (ER) overnight versus when they     switch more gradually over a week.   "
190813|NCT00347165|"     The purpose of this study is to determine whether intravitreal injection of bevacizumab is     effective in the treatment of neovascular age related macular degeneration   "
190814|NCT00347178|"     This is a multicentric, randomised, controlled study comparing Laser Iridotomy (LI) to no     treatment in subjects with asymptomatic narrow angles (ANA).One eye of each subject with ANA     will be randomised to undergo LI and the other eye will be left alone and will serve as an     internal control. Subjects are proposed to be followed up once a year for 5 years.   "
190815|NCT00347191|"     The purpose of this study is to evaluate the relationship between intraocular pressure and     central corneal thickness using various instruments in ocular hypertension, normal-tension     glaucoma, primary open angle glaucoma, keratoconus and normal eyes.   "
190816|NCT00347204|"     To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS &     Nevanac) to help control pain following Photorefractive Keratectomy (PRK).   "
190820|NCT00347256|"     The purpose of this study is to determine the efficacy of concurrent chemotherapy and     radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main     objectives of this study are: 1) to measure the rate of complete response to preoperative     chemoradiation and 2) to study the efficacy of combining preoperative chemoradiation and     surgery in terms of local control of the cancer two years post treatment.   "
190821|NCT00347269|"     This study will compare the effectiveness of an intervention strategy for the treatment of     people with post traumatic stress disorder, generalized anxiety disorder, panic disorder, and     social anxiety disorder in the primary care setting.   "
190832|NCT00347412|"     The purpose of this clinical trial is to find out whether or not the combination of NOV-002     with chemotherapy (paclitaxel and carboplatin) is better at improving overall survival time     when compared to chemotherapy alone in people with non-small cell lung cancer (NSCLC).      Earlier clinical trials in NSCLC showed that patients treated with NOV-002 in combination     with chemotherapy had a better response (their tumors got smaller in one United States Phase     1/2 trial) than patients who received chemotherapy alone; and in two Phase 2 trials done in     Russian patients, at the end of one year, patients treated with NOV-002 with chemotherapy had     a better survival rate than patients who did not receive NOV-002 with their chemotherapy.   "
190822|NCT00347282|"     Superior sulcus deformity in post-enucleation socket syndrome (PESS) may pose a significant     cosmetic blemish after enucleation surgery despite apparently adequate orbital volume     replacement. The underlying reasons include the lack of accurate pre-operative volumetric     assessment of the anophthalmic socket, leading to either under or over estimation of the     orbital implant required and the shifting in orbital and periocular structures that may occur     post enucleation. Conventional imaging studies (computed tomography and magnetic resonance     imaging) have been used to study the anatomy of anophthalmic sockets, but there are several     drawbacks such as poor image quality for detailed volumetric assessment, long exposure time     with possible motion artifact and etc. The new multi-detector computed tomographic technology     is the latest advance in diagnostic radiology that allows rapid high resolution images to be     obtained for three dimensional reconstruction and volumetric assessment. This new imaging     modality will contribute greatly to the understanding of PESS and the surgical planning of     anophthalmic sockets reconstruction.      This is a pilot study aiming to collect clinical data on the volumetric and structural     changes in PESS. The information obtained will:        1. allow more accurate volume estimation of the primary orbital implants prior to          enucleation surgeries, thus minimize the development of PESS;        2. evaluate the volumetric & structural anomalies that constitute PESS        3. be used for the development of a new customized secondary orbital implant to manage          superior sulcus deformity in PESS.   "
190823|NCT00347295|"     To investigate the efficacy and safety of Brotizolam in the treatment of patients with     insomnia in comparison with that of Estazolam   "
190824|NCT00347308|"     Forehead and eyebrow surgery is a frequently performed cosmetic surgical procedure in which     the eyebrows are raised to a more aesthetically pleasing position. Typically, this position     is judged by the surgeon pre-operatively based on traditional aesthetic concepts, some of     which date to the Classical era. This study is designed to assess the variance of the eyebrow     from the desired aesthetic position (as determined by the subject), as wel as to assess the     distance of normal excursion of the brow from maximum voluntary depression to maximum     voluntary elevation.   "
190825|NCT00347321|"     This is a phase III clinical trial comparing early tracheostomy (day 4) versus prolonged     endotracheal intubation in ICU patients needing prolonged ventilatory support after     cardiovascular surgery.   "
190826|NCT00347334|"     The term torticollis is Latin for twisted neck. It can be caused by a tightness of the     sternocleidomastoid muscle manifested by a head tilt to the same and neck rotation to the     opposite side. Treatment includes a comprehensive physical therapy program. Torticollis     typically presents itself within the first three months of life. Currently research in     infants concludes that a physical therapy stretching program is effective in the majority of     cases.1      The study will determine how positioning time correlates to rate of recovery. Overall     incidence of torticollis has increased dramatically since the inception of the back to sleep     program in 1994.2 The back to sleep program is an educational awareness program promoting     families to place infants to sleep on their backs to reduce the risks of sudden infant death.     The increase use of semi-upright positioning equipment prior to developmental head control     may also be contributing to the increase. Families are placing babies in semi-upright     position ie. car seat or swing prior to developmental head control. Head control typically     emerges by three months of age. Unfortunately the use of positioning devices occurs prior to     the child reaching their third month birthday.      The specific aims of the study will include measuring the rate of recovery for infant     torticollis. Recovery will be defined as achieving full neck rotation and no head tilt. The     length of time spent in developmental positions and positioning equipment such as belly     lying, side lying, semi-upright and sitting will also be monitored and recorded. No specific     position will be prescribed; the study will monitor positions only.      Treatment will be initiated upon referral to Cleveland Clinic Children's Hospital for     physical therapy evaluation. Baseline for cervical rotation and lateral tilt will be     assessed. Families will be trained regarding a home stretching program and asked to diary     home positioning time. Routine plan of care will continue a minimum of every other week until     full active range of motion is achieved. At each visit cervical range of motion will be     determined as well as parent report regarding home positioning time. Recovery will be defined     as full active range of motion, no head tilt, and symmetrical head righting reactions. Post     recovery analysis of recovery rates and positioning time will be done to assess correlations.   "
190827|NCT00347347|"     A thorough ophthalmic examination of a child must include a refraction and this is often done     with cycloplegia. In our study, we aim to determine at which age group a non-cycloplegic     refraction technique closely correlates with a cycloplegic refraction and hence, would     obviate the need for cycloplegic refraction in our routine clinical practice.   "
190828|NCT00347360|"     This is a randomized, double-blind, double-dummy, parallel group trial employing 15 cells of     a 4x4 factorial design (no placebo)to compare the hypertensive effects in patients with Stage     1 and Stage 2 hypertension of carvedilol (20, 40 or 80 mg daily) alone, lisinopril (10, 20 or     40 mg daily) alone, and all combinations of the doses.   "
190829|NCT00347373|"     The purpose of this clinical trial is to examine the effects of a low and high dose of     conjugated linoleic acid supplement on body composition in obese humans. Individuals with a     body mass index between 30 and 35kg/m2 are randomized to receive either placebo, 3.2gCLA, or     6.4g CLA daily for twelve weeks. Changes in body composition, weight, and clinical laboratory     values are compared between the three groups.   "
190841|NCT00347529|"     The purpose of this study is to evaluate how well the vaccine is tolerated at sites where     administrations are given, any effects it may have on subjects' wellbeing and whether it can     produce antibody responses in the body that may protect against the subjects catching a     pandemic strain of flu   "
190830|NCT00347386|"     Infections are the important cause of high mortality in young infants in developing     countries. Zinc is a crucial micronutrient as it influences various immune mechanisms and     modulates host resistance to several pathogens. It has shown benefits as an adjunct therapy     in infections like diarrhea and pneumonia in older children Given the predisposition of young     infants in developing countries to zinc deficiency and infections, addition of zinc to     standard treatment of serious bacterial infections may lead to significant improvements in     the outcomes.      Several hypotheses will be examined in this clinical trial. The primary objective is to     measure, in a double blind randomized controlled trial, the efficacy of giving 2 RDA     (Required Daily Allowance 10 mg) of zinc orally in addition to routine antibiotics, for     treatment of possible serious bacterial infection in infants >= 7 days and up to 4 months of     age in reducing the proportion of treatment failures and time to discharge from the hospital.     This will evaluate the clinical consequences of the possible immunomodulation by zinc     supplementation. This is critical to demonstrate because nearly 80% of infant mortality     occurs in first months of life.      Young infants with possible serious bacterial infections fulfilling the inclusion criteria     will be enrolled in the study and stratified into 4 groups on basis of weight for age 'z'     scores < -2 z and >=- 2 z and whether he/she has diarrhea or not. Within each stratum the     subjects will be randomized to receive zinc or placebo. Treatment failures will be defined by     the need for a change of initial antibiotic therapy. The minimum duration of monitoring will     be till clinical recovery (using predetermined criteria). Serum copper, serum ferritin and     serum transferrin receptors will be determined at enrollment, 72 hours after enrollment and     at discharge from the hospital. Concentrations of CRP and procalcitonin will be measured at     baseline, 72 hours after enrolment and at clinical recovery.      Documentation of efficacy of addition of zinc to standard therapy may provide a simple and     low-cost strategy to improve survival in serious infections in young infants. This is likely     to have a significant impact on infant morbidity and mortality. It will be good example of     using a simple immunomodulator beneficially in improving child health.   "
190831|NCT00347399|"     The purpose of this study is to determine if of combination therapy of intravitreal     bevacizumab 4 days after the application of photodynamic therapy could improve the visual     outcomes of patients with neovascular age related macular degeneration.   "
190833|NCT00347425|"     The study will evaluate the safety and tolerability of switching subjects with schizophrenia     or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.   "
190834|NCT00347438|"     The purpose of this study is to assess the safety and effectiveness of capecitabine before     surgery.      The study will also help gain more information about the effects of the capecitabine on     physical and emotional well-being and how well the participants on capecitabine follow the     study drug plan.   "
190835|NCT00347451|"     The prevalence of myopia in East Asia and Singapore in particular is amongst the highest in     the world, with estimates ranging from 30-70% of the general population. Up to 30% of these     are high myopes. High myopia is associated with degenerative changes in the fundus. It may     also be associated with vision-threatening complications such as macular holes. The     pathogenesis of macular holes in high myopes is not completely understood but is postulated     to include a combination of anterior vitreous traction and posterior staphyloma formation and     axial elongation. These forces lead to degenerative changes at the macula, including foveal     detachment and retinoschisis that precede the formation of lamellar or full thickness macular     holes. These changes are difficult to detect either clinically or by conventional imaging     such as ultrasound, making efforts to correct them in the early stages with surgery     difficult. High myopia is also associated with a two- to threefold increase in risk of     developing glaucoma. However, the diagnosis of glaucoma in high myopes is difficult as many     of the pathological changes in the myopic eye mimic those seen in glaucoma. The myopic optic     disc in particular is notoriously difficult to differentiate from the glaucomatous disc.     Currently, the diagnosis is highly subjective, relying on observations of the clinical     appearance of the disc or on disc photos.Optical coherence tomography (OCT) is an evolving     technology that relies on time delays of reflected or backscattered light and interferometry     to yield cross-sectional images of the retina and optic disc. The Stratus OCT is the latest     model and has been demonstrated to be able to yield images with a resolution comparable to     that of histology. It is thus potentially useful in assessing degenerative changes occurring     in the myopic fundus, in evaluating the early changes preceding macular hole formation, and     in providing objective measures of various disc parameters to aid in diagnosing glaucoma in     high myopes. This study aims to recruit 150 healthy, young, ophthalmologically normal males     from the SAF and to examine them with OCT. High myopes (≤-8D) will be selected and compared     with a control group of low myopes. The performance of the OCT will be evaluated against     current diagnostic methods.   "
190836|NCT00347464|"     Klinefelter syndrome, a congenital chromosomal abnormality with one or more extra X     chromosomes, occurs in out of 400 live male births. The majority of Klinefelter men present     with a 47, XXY karyotype. The poly-X variant, with the 49,XXXXY karyotype is uncommon. This     syndrome, where subjects have two or more X chromosomes presents with primary hypogonadism,     and, particularly if associated with the 49,XXXXY karyotype, significantly impacts life     skills across a variety of dimensions, including areas of communication, community use,     functional academics, home/school living, health and safety, leisure, self-care, self     direction, and work. Adaptive behavior abnormalities in 46,XXY men are well known and     described. In the poly-X variant of the 49,XXXXY karyotype, adaptive behavior abnormalities     are expected to be much more significant, making these patients eligible for services and     Social Security benefits.      In 49,XXXXY men no study to date has examined these areas of inquiry in a large patient     population, using a psychometrically sound instrument in a large patient population. Current     publications are limited to individual case reports or small case summaries. It is important     to study the adaptive behavior in its highly abnormal presentation in 49,XXXXY men in order     to learn more about the effect of additional X chromosomes on adaptive skills, which     determine how an individual responds to daily demands and in order to develop treatment and     training goals.   "
190837|NCT00347477|"     Therapeutic hypothermia after cardiac arrest har shown to improve the rate of survival in a     significant way. However hypothermia also causes leak of fluid into the surrounding tissue.     This edema could lead to damage to the same tissue, not beneficial for the patients. We     therefore try to evaluate if hyperosmolar, hyperoncotic fluid as an alternative to std.     treatment (NaCl/RA)could affect the edema in a positive way, and result to a better outcome     neurological for the patients.   "
190838|NCT00347490|"     Primary objective:      To assess clinical efficacy of single bolus anticoagulation with Enoxaparin in chronic     hemodialysis      Secondary objective:      To assess safety and tolerability by the number of spontaneously reported adverse events by     patients   "
190839|NCT00347503|"     Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition     in human patients.   "
190840|NCT00347516|"     Implantation of an intraocular lens is the gold standard in modern day cataract surgery.      The appropriate lens power needed to achieve the desired refractive outcome can be calculated     with a whole variety of formulas.      To date, there has been no prospective study conducted to evaluate the accuracy of the IOL     power calculation formulae commonly in use. It is well established that the frequently used     IOL formulas do not show significant differences when used in eyes of average axial length     (i.e. between 22mm and 25mm) and it is at the extremes of axial lengths where discrepancies     arise. Our aim is to find the most appropriate formula(e) for these 'long' and 'short eyes'     particularly in our population where there is a significant proportion of high myopes.   "
190905|NCT00337220|"     The purpose of this study is to determine if analysis of urine samples for specific markers     can predict transplant rejection in people who have received kidney transplants.   "
190842|NCT00347542|"     The purpose of the study is to evaluate the change in glucose and insulin metabolism(early     markers for development of diabetes) after 6 weeks of weekly Vitamin D supplementation. As     vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we     will also be measuring the changes in these variables.   "
190843|NCT00347555|"     Malaria is an illness caused by a parasite (an animal or plant that lives in or on a host)     that enters the human body through the bite of an infected mosquito. The purpose of this     study is to find out about the safety of an experimental malaria vaccine and whether the     vaccine causes humans to produce antibodies (proteins made by the body's immune system to     help control or prevent infection). Four strengths of the vaccine will be tested. The lowest     strength of the vaccine will be tested before the next higher strength is tested. Each dosage     (shot) of vaccine will be given to 18 people in 4 dosage groups on Day 0, at 1 month and at 6     months. Two people in each dosage group will receive injections of a placebo (contains no     medication). Participants will include 80 healthy adults between 18 and 40 years of age.     Multiple blood draws will occur over the duration of the study. Participants will be involved     in study related procedures for approximately 13 months.   "
190844|NCT00347568|"     The purpose of this study is to develop a web-based decision aid to help women at high risk     for breast cancer make informed breast cancer prevention choices. These choices include     chemoprevention, surgery, genetic counseling, or regular screening in accordance with     recommended guidelines.   "
190845|NCT00347581|"     This study is designed to compare the use of special prism glasses to placebo treatment for     children with symptomatic convergence insufficiency.   "
190847|NCT00347607|"     After single, yearly, mass treatment of communities with azithromycin for active trachoma,     what is the added effectiveness for reduction of trachoma and ocular C. trachomatis infection     at one, two, and three years, relative to the added costs, of community-based surveillance     and treatment of cases of severe trachoma (TI) semi-annually or every 4 months?   "
190848|NCT00347620|"     The primary purpose of this study is to evaluate whether interventions to improve vision in     nursing home residents have an impact on residents' health-related quality of life. The     interventions being evaluated are correction of refractive error (near-sightedness,     far-sightedness, presbyopia) and cataract surgery.   "
190849|NCT00347646|"     Plasmin is expected to create a posterior vitreous detachment (PVD) when injected directly     into the eye. The pharmacological creation of a PVD may be beneficial in helping to treat a     variety of conditions.   "
190850|NCT00347659|"     The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction     System (BLVR) for patients with advanced emphysema.   "
190851|NCT00347672|"     Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and     other parts of the world. The need for a vaccine to prevent the spread of AI among livestock     and to humans is sorely needed. The purpose of this study is to test the safety of and immune     response to a new AI vaccine in healthy adults.   "
190852|NCT00347685|"     The purpose of this study is to assess the safety of tramadol HCl ER following long-term     treatment. The study hypothesis is that long-term treatment with tramadol HCl ER is safe and     effective for the treatment of chronic, non-malignant pain.   "
190853|NCT00347698|"     The purpose of the study is to evaluate the safety and efficacy of 2.5 mg of intravitreal     bevacizumab in one eye, versus panretinal photocoagulation in the contralateral eye, for the     treatment of patients with untreated symmetric proliferative diabetic retinopathy.   "
190854|NCT00347711|"     To evaluate the effects of Intravitreal Bevacizumab in macular edema in retinal vascular     occlusion.   "
190855|NCT00347724|"     The purpose of this study is to compare the analgesic efficacy of oral, once-daily tramadol     ER 300 mg and 200 mg to placebo in patients with moderate to severe chronic low back pain     requiring daily analgesic treatment. The study hypothesis is that tramadol ER is effective in     the treatment of moderate to severe chronic low back pain.   "
190856|NCT00347737|"     The purpose of this study is to determine what effect teriparatide will have on vascular     (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).   "
190857|NCT00347750|"     The objective of this proposal is based on the assumption that the HIV infected Ethiopian     population responded in a different way in comparison to the Caucasian subjects to Lopinavir     therapy. Our preliminary data demonstrated that Ethiopian's have different Lopinavir serum     concentration in comparison to non-Ethiopian's. For these reasons the plan of this study is     to investigate the pharmacokinetic/pharmacodynamic (PK/PD) profile in both populations. The     results will allow to establish a better personalised medicine for HIV infected individuals.   "
190858|NCT00347763|"     The purpose of this community-based randomized trial was to determine, in trachoma     hyper-endemic communities of Tanzania, the added value of intensive spraying to control flies     on the fly population and on trachoma and ocular chlamydia infection at 6 months and one year     after mass antibiotic treatment.   "
190859|NCT00347776|"     Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of     blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar     and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and     abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a     multi-faceted strategy to combat trachoma, which includes surgery to correct trichiasis.     Despite this encouraging news, under the best of circumstances the recurrence rate of     trichiasis following surgery is disappointingly high. The objective of our project is to     conduct a randomized, controlled clinical trial of post-surgical antibiotic treatment,     comparing oral azithromycin to topical tetracycline, for trichiasis surgical patients in     Ethiopia with the goal of determining the impact of treatment on rates of trichiasis     recurrence at one and two years.   "
190860|NCT00347789|"     Transconjunctival mitomycin-C in needle bleb revision may be an effective procedure to treat     cases with a previously failed trabeculectomy. We will investigate approximately 100     consecutive cases with follow up of up to 9 years. We anticipate that this procedure is an     effective, safe, and appropriate option for successful glaucoma treatment.   "
190861|NCT00347802|"     To compare the diurnal curves in patients using bimatoprost 0.03% versus travoprost 0.004%     for the treatment of glaucoma or ocular hypertension.   "
190862|NCT00347815|"     The purpose of this study is to determine the amount of buprenorphine and its metabolites in     blood and urine after administration of 0.6 mg buprenorphine in healthy volunteers.     Furthermore the purpose is to correlate the amount of buprenorphine in the blood with the     effect on the ability to concentrate and coordinate.   "
190863|NCT00347828|"     The purpose of this study is to analyze the effect of Zymar and Vigamox on ocular surface     bacteria. We believe that Zymar will eradicate more ocular surface bacteria than Vigamox.   "
190864|NCT00347841|"     To evaluate the IOP-lowering efficacy of bimatoprost 0.03% in patients found to be     low-responders to latanoprost therapy.   "
190865|NCT00347854|"     The objective of this study is to evaluate the safety and efficacy of exaggerated use of     Lubricant Eye Drops in a population of normal subjects by measuring corneal epithelial     permeability to fluorescein.   "
190866|NCT00347867|"     It has been suggested that Viagra (or other drugs that inhibit PDE-5, the enzyme that     normally inhibits blood vessels’ ability to expand) may have beneficial effects in     hypertensive pregnancy and, possibly, preeclampsia.The benefits of Viagra were observed     without any reduction in maternal blood pressure, thereby dissociating hypertension per se     from the loss of NO (nitrous oxide) signaling in the uterine circulation.Following     publications, suggesting that sildenafil citrate used as a therapeutic agent may improve     myometrial perfusion in IUGR gestations by promoting myometrial small artery vasodilatation,     decreasing peripheral resistance and increasing flow within the uteroplacental bed, we intend     to administer this medication to parturients where intauterine growth restriction and     pregnancy associated hypertension have been diagnosed in an attempt to induce vasodilatation     and improved uteroplacental perfusion resulting in improved fetal growth.   "
190867|NCT00347880|"     The purpose of this study is to collect information about what happens to certain chemicals     produced in the body called hormones during respiratory infections such as bronchiolitis.     Bronchiolitis is an infection of small airways in the lungs caused by a virus. This     infection, which causes swelling and injury in the lungs, is commonly seen in infants and     children less than 2 years of age.   "
190868|NCT00347893|"     Selective laser trabeculoplasty (SLT) is a new method to reduce intraocular pressure in eyes     with open angle glaucoma or ocular hypertension. SLT may also be effective for cases with     previously failed ALT procedures. We will study the efficacy and safety of the SLT procedure.   "
190869|NCT00347906|"     The purpose of this study is to compare the effect of PDT and TTT for the treatment of     subfoveal occult CNV in age-related macular degeneration.   "
190870|NCT00347919|"     This study is being conducted to compare the efficacy and safety of pazopanib in combination     with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic     breast cancer whose tumors overexpress the ErbB2 protein.   "
190871|NCT00347932|"     Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the     treatment of bacterial conjunctivitis.   "
190872|NCT00347945|"     The Convergence Insufficiency Treatment Trial (CITT) is a multi-center, placebo-controlled,     single-masked, clinical trial designed to compare the benefits of two commonly used treatment     approaches for patients with convergence insufficiency (CI)   "
190873|NCT00347958|"     Objectives:      To provide safety data on revaccination with ADACEL® vaccine.      To describe the immune response to tetanus, diphtheria, and pertussis antigens following     revaccination with ADACEL® vaccine 4-5 years after first vaccination.   "
190874|NCT00347971|"     The purpose of the study is to evaluate whether recombinant IL-21 used in combination with     rituximab is safe for patients with non-Hodgkin's lymphoma (NHL).   "
190875|NCT00347984|"     The objective of this study was to evaluate the effect of Systane® compared to marketed     artificial tears on the frequency of drop use.   "
190876|NCT00347997|"     A Study to demonstrate the safety and efficacy of wavefront laser refractive surgery     treatments for myopia and astigmatism.   "
190877|NCT00348010|"     The purpose of this study is to compare the analgesic effectiveness and safety of tramadol     HCl ER to placebo in patients with moderate to severe pain due to osteoarthritis (OA). The     study hypothesis is that tramadol HCl ER is effective and safe in the treatment of OA.   "
190878|NCT00348023|"     Evaluate the IOP-lowering efficacy and quality of life in patients using bimatoprost 0.03%     monotherapy versus dual therapy with travoprost 0.004% and timolol 0.5% for the treatment of     glaucoma or ocular hypertension.   "
190879|NCT00348036|"     This study will assess the acceptability and effectiveness of a six-session, modular,     repeating group for low-income women who have symptoms of depression and/or post-traumatic     stress disorder following interpersonal trauma exposure.   "
190880|NCT00348049|"     Laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) are currently the     2 main refractive surgeries to correct myopia which are being performed worldwide, with more     patients preferring LASIK to PRK because of better comfort and faster rehabilitation.     However, in post-LASIK patients, there is a low risk of flap dislodgement. This risk     increases with certain occupations which have a higher risk of trauma. Hence, there may be a     role for PRK for people which such occupations, e.g. soldiers, parachutists, sportsman.      There are several non-randomised studies which show that PRK is as efficacious, predictable     and safe as LASIK for low to moderate myopes. But there have been only a few randomized     controlled studies to compare the efficacy and safety of the 2 treatment modalities and all     studies comparing LASIK and PRK suffer from a high dropout rate during the follow-up period.     We compared the efficacy, predictability, stability and safety of LASIK versus PRK over a one     year duration with almost 100% attendance during all follow-up visits.   "
190881|NCT00348062|"     Evaluate the incidence of hyperemia in patients using bimatoprost and to determine if simple     interventions reduce its incidence and to assess the value of detailed instruction in     increasing patient compliance and willingness to continue bimatoprost therapy, despite the     occurrence of hyperemia.   "
190882|NCT00348075|"     To evaluate the efficacy of NeuroVision NVC vision correction technology to improve the     vision of subjects with Low and Moderate Myopia in Asian eyes in Singapore   "
191211|NCT00349219|"     The purpose of this study is to compare first-line erlotinib followed at progression by     second-line chemotherapy vs. first-line chemotherapy followed at progression by second-line     erlotinib in the treatment of Advanced Non Small Cell Lung Cancer (NSCLC).   "
190883|NCT00348088|"     The purpose of this study is to measure the level of a specific protein, CXCL1, in the blood     of patients with untreated, metastatic (Stage IV) melanoma. These levels will be compared to     blood levels in normal controls. If the levels are elevated in metastatic melanoma, further     studies to determine if this correlates with presence and extent of disease will be pursued.   "
190884|NCT00348101|"     Previous clinical investigations have demonstrated the utility of β-adrenergic blockade in     reducing perioperative ischaemic events, ultimately translating into a decrease in cardiac     morbidity and mortality. However, β-blocker therapy remains underutilized in clinical     practice because of concerns of potential adverse effects such as a reduced inotropic state,     which might result in acute congestive heart failure or hypotension. Therefore, additional     treatment with a positive inotropic agent might be needed. Phosphodiesterase inhibitors     (PDEIs) offer a favourable pharmacological profile in this setting and stimulate cardiac     function in the absence of the β-adrenergic receptor.      We hypothesize that the combination of PDEI and β-blocker therapy would decrease     perioperative plasma concentrations of brain natriuretic peptide (BNP) in patients requiring     major vascular surgery. BNP is chosen as our primary outcome variable because of its     importance as a sensitive correlate of myocardial dysfunction and its prognostic value for     predicting the risk of cardiac death across the entire spectrum of acute coronary syndromes.   "
190885|NCT00348114|"     To evaluate the effectiveness of autologous (tissue from fellow eye) transplantation of     cultivated limbal epithelium on amniotic membrane to treat severe surface irregularity and     scarring of the corneal surface.   "
190886|NCT00348127|"     To assess how well and safe is Neurovision technology in improving the vision of people with     low myopia in Singapore   "
190996|NCT00339118|"     The purpose of the study is achieve standardization treatment of low and intermediate risk     rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high     risk patients by the addition of doxorubicin as induction treatment and at the maintenance     phase.   "
190887|NCT00348140|"     Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a     treatment for type II diabetes mellitus, a disease that occurs when the body is unable to     effectively use glucose. RSG XR, the investigational drug used in this study, is an     extended-release form of RSG.      This study tests whether RSG XR safely provides clinical benefit to people with mild to     moderate Alzheimer's disease (AD) when combined with one of the currently approved AD     medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this     study tests a new way to treat AD by testing whether one's genetic makeup affects the     response to the study drug. Clinical data suggesting that RSG may benefit AD patients was     first seen in a small study performed at the University of Washington and then from a larger     GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG     once daily for 6 months scored significantly better on 3 tests of memory and thought than     those who did not receive RSG. In the GSK study, those that appeared to benefit most from     treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused     them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene     may have two copies, one from each parent, or they may have only one APOE e4 gene meaning     that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4,     from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same     level of thinking ability while those with two copies of the APOE e4 gene, continued to     worsen during the 6-month treatment. The current study will more directly test the     effectiveness or RSG XR on people who either have or lack the APOE e4 gene.   "
190888|NCT00336973|"     This is a Phase IV open-label study to evaluate the efficacy and safety of SC efalizumab in     adult subjects (18 years of age and older) with chronic moderate or worse plaque psoriasis     who have had an inadequate response to treatment with an anti-TNF agent. The study will     consist of a screening period, a treatment period, and an observation period. All subjects     will begin in the screening period (the length of which is dependent on the previous anti-TNF     agent treatment). Approximately 100 eligible subjects will receive treatment from Day 0     through Day 168.   "
190889|NCT00336986|"     This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At     least 14 to a maximum of 40 patients, who have not previously received treatment for their     stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.   "
190890|NCT00337012|"     This study focuses on possible mechanism mediating duloxetine effects on painful physical     symptoms in patients suffering from MDD. Our hypothesis is based on the assump¬tion of dual     impairment of the somatosensory system in these patients. Hypalgesia to phasic experimental     pain may be due to diminished spinal and brainstem transmission. Hyperalgesia may be     at¬tributed to increased interoceptive perception (somatic complaints, especially those     consist¬ing in pain) due to sensitisation or lack of inhibition of the interceptive     perception. These ef¬fects seem to be mediated by specific brain regions (e.g. the right     insula). The investigators intent to test if duloxetine effects on these somatic complaints,     especially pain complaints are due to a nor¬malization of these interceptive alterations     which have been reported to be associated with depressive symptoms. The investigators     hypothesize that treatment with duloxetine will normalize patho¬logical activation patterns     (as assessed by fMRI) associated with increased interoceptive perception.   "
190891|NCT00337038|"     Our aim is to examine the influence of blood pressure and glycemic control together with     N-acetylcystein utilization on the endothelia function of hypertensive diabetic patient.The     study population will include 50 diabetic patient with uncontrolled hypertention that will be     recruited from the Hypertension Clinic of Soroka University Medical Center.   "
190906|NCT00337233|"     RATIONALE: Yoga may improve symptoms and quality of life and reduce stress in patients with     ovarian cancer or breast cancer and may help them live more comfortably.      PURPOSE: This clinical trial is studying how well yoga works in controlling symptoms and     reducing stress in women with ovarian cancer or breast cancer.   "
190968|NCT00338091|"     The primary goal of the trial was to evaluate whether the optimal antiproteinuric doses of     benazepril (an ACE inhibitor) or losartan (an ARB), as compared with their conventional     doses, can safely improve the long-term renal outcome in nondiabetic patients with     proteinuria and chronic renal insufficiency. The second aim was to compare the long-term     renal protection between benazepril and losartan at similar clinical setting.   "
190892|NCT00337051|"     Renal transplantation is characterized by ischemia-reperfusion lesions in allograft. In a     previous study, Julier and al. (Anesthesiology 2003) have demonstrated that sevoflurane     reduces glomerular lesions in kidney of patients undergoing a cardiovascular surgery and     présenting with ischemia-reperfusion phenomena.      The purpose of the study is to evaluate the effects of sevoflurane on the recovery of renal     graft function in patients after kidney transplantation.      This study will be a randomized, double blinded, controlled clinical trial and 120 patients     undergoing renal allograft transplantation will be included.      Patients will be divided into 2 groups: one group of patients who will receive sevoflurane     (evaluated treatment) for anaesthesia and the other one who will receive propofol (reference     treatment).      We will evaluate renal function for one year after transplantation. Ours results will confirm     or not that sevoflurane protects kidney function from ischemia-reperfusion lesions.   "
190893|NCT00337064|"     The standard treatment for women with invasive breast cancer is local excision follow by     whole breast radiation. The local recurrence rates are low, side effects are low, and the     cosmetic outcome is excellent. The treatments, however, need to be given daily for 5 1/2 to 6     1/2 weeks, making the treatment difficult, particularly for the elderly and for women who     need to travel long distances for the therapy. The goal of this study is to determine the     toxicity and efficacy of giving the radiation in a shorter time, using higher daily doses of     radiation.      The risk of recurrence in the elderly population is lower, and since majority of recurrences     occur close to the area where the tumor previously was, it is hypothesized that radiation to     that area of the breast would be sufficient to obtain low risk of recurrence. When a smaller     volume of tissue is treated, more radiation can be given daily, and therefore the treatment     can be shortened. The risk of side effects increases as the dose per daily treatment     increases. Therefore, the goal is to study the short term side effects, long term side     effects, and cosmetic outcome of daily radiation using higher daily doses for shorter period     of time. We will also follow the recurrence rate. Because less of the breast tissue will be     treated, there may be a small increased risk of recurrence. Because the higher fraction size     can result in more side effects we will be using intensity modulated radiation (IMRT). IMRT     is the most advanced individually tailored radiation treatment technique that results in the     least amount of side effects. It allows tight monitoring of the dose in the untreated breast.      Seventy five women diagnosed with stage I breast cancer will participate. Participants must     have a lumpectomy, clear margins and no lymphovascular invasion to be eligible. A treatment     planning CT scan will be obtained. If the lumpectomy cavity can be clearly delineated, an     IMRT plan will be generated with predefined strict dose requirement criteria. The patients     will be treated once daily, 5 days a week, for a total of 10 treatments (instead of standard     28-33). The patients will be evaluated for toxicity weekly during the treatment, and weekly     for additional 4 weeks. At each of these evaluations, they will fill out a short 10 minute     questionnaire detailing their side effects. Follow-up will continue every 3 months for 3     years, and every 6 months for 2 more years. At each of these follow-ups a short questionnaire     will be filled out by the patients detailing any toxicity, as well as their perception of the     cosmetic outcome. A cosmesis questionnaire will be also be filled out by the evaluating     physician before radiation, at 6, 12, 18, and 24 months, and yearly for 3 more years. A total     of 5 years of follow-up is planned. Participants will also have the option of consenting to     the photograph portion of the study. Those who do will have photographs taken of their     breasts (excluding faces) at the time they complete the cosmetic questionnaire, to evaluate     the cosmetic outcome.   "
190894|NCT00337077|"     This phase II trial is studying how well eribulin mesylate (E7389; Halichondrin B Analog)     works in treating patients with metastatic prostate cancer that did not respond to hormone     therapy. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.   "
190896|NCT00337103|"     The purpose of this study is to compare E7389 versus capecitabine in patients with locally     advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This     is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive     either E7389 or capecitabine on a one-to-one ratio.   "
190897|NCT00337116|"     This is a randomized, double blind, placebo-controlled study, clinical trail designed to     evaluate the efficacy safety and superiority of intravenous boluses of isosorbide dinitrate     for the relief of acute anginal pain episodes in acute coronary syndrome patients in     comparison with the usual manner of S/L isosorbide dinitrate .   "
190898|NCT00337129|"     RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well E7389 works in treating patients with     metastatic or recurrent head and neck cancer.   "
190899|NCT00337142|"     Infants to diabetic mothers (IDM) are at risk for developing hypoglycemia after birth.     Glucose level follow ups are recommended to each IDM. However, there are no recommendations     as to how long this follow up should be performed for, nor are there safe glucose levels     that allow stopping glucose monitoring.      The aim of the study is to retrospectively follow up glucose levels among IDMs in order to     find risk factors for developing hypoglycemia and determine time and glucose levels that     would permit monitoring cessation.   "
190900|NCT00337155|"     The purpose of this study is to evaluate the effectiveness of the investigational     radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone     metastases that no longer respond to hormonal treatment.   "
190901|NCT00337168|"     RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving cytarabine together with clofarabine     works in treating patients with relapsed or refractory acute lymphoblastic leukemia.   "
190902|NCT00337181|"     This protocol will study the clinical course of HIV-infection among volunteers who have     received either a placebo injection or the experimental vaccine combination of ALVAC-HIV and     AIDSVAX B/E prior to HIV-1 infection. The study will assess whether those who received the     experimental vaccine combination have a slower progression of HIV disease compared to those     who received the placebo injection.   "
190903|NCT00337194|"     This randomized phase II trial studies the side effects and how well giving monoclonal     antibody SGN-30 together with combination chemotherapy works in treating patients with     Hodgkin lymphoma that has returned after a period of improvement or did not respond to     previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of     cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine     hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination     chemotherapy may kill more cancer cells and shrink tumors.   "
190904|NCT00337207|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with     recurrent or progressive glioma.   "
190907|NCT00337246|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and     mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can     block cancer growth in different ways. Some block the ability of cancer cells to grow and     spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. Giving combination chemotherapy together with rituximab may kill more cancer cells. It     is not yet known whether giving combination chemotherapy together with rituximab is more     effective than combination chemotherapy alone in treating chronic lymphocytic leukemia.      PURPOSE: This randomized phase II trial is studying how well giving combination chemotherapy     with or without rituximab works in treating patients with previously treated chronic     lymphocytic leukemia.   "
190908|NCT00337259|"     Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with     chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma.     Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have     anti-lymphoma activity. To the investigators' knowledge, there has been no trial of     gemcitabine for marginal zone lymphoma. Thus the investigators made a plan to investigate the     role of gemcitabine in marginal zone lymphoma.   "
190909|NCT00337272|"     This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the     treatment of insomnia in patients that have completed their first chemotherapy treatment for     breast cancer.   "
190910|NCT00337285|"     The purpose of this study is to assess the long-term safety and efficacy of three NRP104     doses of 30 mg, 50 mg, or 70 mg, administered at the same time daily, in the treatment of     adults with ADHD.   "
190911|NCT00337298|"     The purpose of this study is to compare the effect of two antihypertensive drugs on retinal     vessel diameter in young type 1 diabetics. The retinal vessel analyzer (RVA) was used to     investigate how the drugs affected vessel diameter, when the subjects were exposed to an     increase in blood pressure, induced by isometric muscle contraction and when they were     stimulated by flickering light.   "
190912|NCT00337324|"     We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain     in patients with painful diabetic neuropathy.   "
190914|NCT00337350|"     We propose an eight-week, double-blind, placebo-controlled trial of rosiglitazone in     schizophrenia subjects treated with clozapine using Bergman's Minimal Model (MINMOD)     intravenous glucose tolerance test. Bergman's Minimal Model analysis with frequent sampled     intravenous glucose tolerance test (FSIVGTT) provides a sensitive and reliable method to     measure glucose effectiveness, insulin secretion and insulin sensitivity. The MINMOD     determines the relationship between insulin sensitivity, insulin secretion and the degree of     obesity and can be used to study drug effects upon these variables.   "
190915|NCT00337376|"     Rapamycin is a drug that has been approved by the Food and Drug Administration (government)     for use in patients receiving a kidney transplant to prevent the patient's body from     rejecting the transplanted kidney. It has shown antitumor effects in the laboratory, but has     not been approved at this time for the treatment of cancer. Abraxane is a new form of     chemotherapy that has been approved by the Food and Drug Administration for the treatment of     metastatic breast cancer, and is a promising drug that is being evaluated in clinical trials     for treatment of other cancers. This is a phase I study designed to find out if different     doses of Rapamycin, when combined with Abraxane, are safe and well tolerated.   "
190916|NCT00337389|"     To compare the progression-free survival time (PFS) in patients treated with 5-FU modulated     with CoFactor (plus bevacizumab) to 5-FU modulated with leucovorin (plus bevacizumab) in     patients with Metastatic Colorectal Cancer.   "
190917|NCT00337402|"     Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients.     Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on     effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France     (observational study)   "
190918|NCT00337415|"     A Research Study to Evaluate the Effectiveness and Tolerability of MK0354 vs Placebo (an     inactive look alike pill) in Lipid (fat) Altering in Patients with dyslipidemia (a disorder     of lipids in the blood)      This is an early phase trial and some specific protocol information is proprietary and not     publicly available at this time. (Full information is available to trial participants).   "
190919|NCT00337428|"     Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus     [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined     diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic     and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.   "
190920|NCT00337441|"     The purpose of this study is to determine if chronic anemia can be corrected with epoetin     alfa and does the subsequent correction lead to an improvement in fatigue,quality of life or     mobility among elderly.   "
190921|NCT00337454|"     This study is composed of Phase I and Phase II part. Phase I part: The objective is to     evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia     (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The     objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the     results of Phase I part. Treatment period will be 6 months for subjects with chronic phase     CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia     Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)   "
190922|NCT00337467|"     The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced     protease inhibitor therapy can maintain virologic suppression without a marked increase in     virologic failure.   "
190923|NCT00337480|"     The purpose of this study is to determine whether the follow up of patients with acute     coronary syndrome and modifiable cardiovascular risk factors is efficient based on     outpatients visits in a House of Education, underlining the importance of nicotinic weaning,     weight loss and physical activity practice.   "
190967|NCT00338078|"     The purpose of this study is to determine whether oxygen therapy during sleep improves     quality of life, exercise capacity and heart function among patients with chronic heart     failure and central sleep apnea.   "
190985|NCT00338975|"     This study evaluated the effectiveness of Cognitive Behavioral Social Skills Training versus     goal-focused supportive contact in improving social functioning in people with schizophrenia.   "
190924|NCT00337493|"     This study will determine which, if any, allelic variants of mycophenolic acid (MPA)     metabolizing enzymes, drug transporters and drug targets are associated with the observed     variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage.     Patients participating in study ML17225 will be eligible for this pharmacogenetic     investigation, and will have one additional blood sample taken during the study. The     anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size     is 500+ individuals.   "
190925|NCT00337506|"     The objective of this study is to evaluate the efficacy and safety of Velcade plus     dexamethasone used as induction chemotherapy prior to autologous transplantation.   "
190926|NCT00337519|"     Patients with advanced chronic lymphocytic leukemia (CLL) have a poor long-term prognosis.     Allogeneic stem cell transplantation (SCT) in patients with CLL has only rarely been     performed in the past because the clinical outcome after myeloablative conditioning was poor,     mainly due to the high treatment-related mortality. However long-term disease-free survival     after allogeneic SCT has been reported. Recently it has been demonstrated by our group and     others that non-relapse mortality can be reduced significantly with the use of     reduced-intensity conditioning regimens. Yet, graft versus host disease (GVHD) remains an     important problem in this setting.      Alemtuzumab is an effective drug for the treatment of patients with advanced CLL and has been     successfully applied for GVHD-prophylaxis in the setting of myeloablative and     reduced-intensity conditioning regimens. The goal of the present study is to evaluate the     role of alemtuzumab as part of a fludarabine-based reduced intensity conditioning regimen for     allogeneic SCT in patients with advanced CLL.   "
190927|NCT00337532|"     The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination     regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer.     the safety of this treatment will also be studied.   "
190928|NCT00337545|"     Single center open-label study of an oral agent (RAD001) in subjects with metastatic     colorectal cancer refractory to at least 2 standard chemo/biologic regimens.   "
190929|NCT00337558|"     This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment     (bladder training) compared to the drug on its own. The study will compare the symptoms of     OAB by assessing patient diaries and other patient reported outcomes.   "
190930|NCT00337571|"     This study will compare the effectiveness (how well the drug works) of aripiprazole with     placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with     a diagnosis of autistic disorder (AD).   "
190931|NCT00337584|"     We are studying whether providing patients undergoing day surgery the opportunity to have     their medical history reviewed by an hospital internist before surgery leads to better     results after surgery. These doctors are internal medicine specialists who are experienced in     assessing patients going to surgery, making sure they are fine-tuned before their     operation. We believe this will ensure the safest and best surgical outcomes. The study     involves the patient filling out a 3 page questionnaire for review by the internist prior to     surgery. Additionally, patients will receive a follow-up phone call one week after surgery     asking about the experience at the hospital and a questionnaire in the mail three months     later to see if the patient had any medical problems after leaving the hospital.   "
190932|NCT00337597|"     This prospective, comparative and double blind study is aimed to determine if normal saline     or dextrose 5% in water will modify the stimulation during the insertion of the stimulating     catheter used for continuous femoral and sciatic blocks in total knee replacement.   "
190933|NCT00337610|"     A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2     Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.   "
190934|NCT00337623|"     Corticosteroid therapy is usually regarded as a risk factor for the development of posterior     subcapsular cataracts but prospective studies on this topic and accurate assessment of this     potential adverse effect are lacking. We will evaluate changes of lens transparency after     administration of systemic corticosteroid therapy for at least one year with Scheimpflug     photography and quantification of lens autofluorescence.   "
190935|NCT00337636|"     Patients with infantile or late infantile NCL have either a reduced amount of, or are     missing, the palmitoyl protein thioesterase 1 (PPT1) enzyme or the tripeptidyl peptidase 1     (TPP-I) enzyme. Human central nervous system stem cells (HuCNS-SC) are an investigational     product derived from human brain cells. HuCNS-SC have been shown to survive and migrate     within the brains of mice. When grown in the laboratory, HuCNS-SC have been shown to produce     the PPT1 and TPP-I enzymes. In mice missing the PPT1 enzyme, HuCNS-SC have been shown to     increase the amount of this enzyme in the brain, to reduce the amount of abnormal storage     material in the brain, and to prevent the death of some neurons (a type of cell) in the     brain.      Participation in this study will involve screening assessments, surgery to implant HuCNS-SC,     medication to suppress the immune system, and a series of follow-up assessments. The length     of time from the start of screening through to the last follow-up visit will be approximately     13 months, with frequent visits to the study center during this time. After completion of     this study, patients will be monitored for an additional 4 years under a separate long term     follow-up protocol.   "
190936|NCT00337649|"     This single arm study will determine the efficacy and safety of an epothilone D and Herceptin     combination regimen in patients with HER-2 positive locally advanced or metastatic breast     cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at     a dose not exceeding 100mg/m2. Herceptin will be administered intravenously on a weekly     schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The     anticipated time on study treatment is until disease progression, and the target sample size     is <100 individuals.   "
190937|NCT00337662|"     The current study has been designed to address the significance of early onset of response     prospectively in patients treated with an atypical antipsychotic.   "
190938|NCT00337675|"     This is a year-long study evaluating the efficacy of both daily and intermittent treatment of     asthma in children who experience symptoms episodically (i.e., seasonally, usually in the     context of upper respiratory tract infection).   "
191212|NCT00349232|"     The purpose of this study is to assess the prevalence of overweight and obesity in children     attending special primary education and to evaluate the effects of a multidisciplinary     school-based lifestyle intervention.   "
190939|NCT00337688|"     There are over 750,000 individuals in the U.S. with Cerebral Palsy (CP). Up to 46% of adults     with CP report limited mobility in their communities. However, upper limb spasticity and     problems with movement can make the independent use of a wheelchair difficult. Forty percent     of individuals who desire mobility via electric wheelchairs are precluded from using them     because of problems with upper limb function. No studies to date have produced devices that     definitively improve mobility for these individuals. We will recruit 22 subjects with Spastic     CP and 22 age and gender matched control subjects without apparent disability from     advertisements, mailings, and outpatient clinics. Both a conventional joystick (MSJ) and a     novel joystick that is customized for each subject will each be used six different computer     screen tasks that simulate driving a wheelchair on a path. We will compare subjects and     joysticks based on driving performance. Understanding problems with driving will help us to     design joysticks and other assistive devices, not only for CP but for Traumatic Brain Injury,     Spinal Cord Injury, Parkinson's Disease, stroke, or a variety of other disabilities.   "
190940|NCT00337701|"     This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc)     using the B2000 needle-free injection device, in HIV-1 positive patients experienced to     Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of     Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device     or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for     the next 4 weeks. The anticipated time on study treatment is <3 months, and the target sample     size is 100-500 individuals.   "
190941|NCT00337714|"     Bloodstream infections are common in Intensive Care Units (ICUs). The need of a central     venous line increases the risk of bacteremia and central venous catheter (CVC) related     infections. The use of catheters coated and/or impregnated with different antimicrobial     agents has been proposed to reduce the risk of such infections. However, results obtained so     far did not reach enough clinical relevance to consider these medicated catheters as a valid     alternative to the conventional ones.      The aim of this comparative randomized study is to assess the ability of recently developed     silver ion-releasing central venous catheters in preventing associated infections in     comparison with the conventional ones.      Experimental groups are defined as follows:        -  Group A: patients treated with standard, triple lumen, non medicated catheters        -  Group B: patients treated with triple lumen catheters impregnated with silver          nanoparticles   "
190957|NCT00337948|"     The purpose of this study is to determine the effectiveness and safety of epoetin alfa at a     starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb) of 12 g/dL     (Initiation Phase), followed by a dose of 60,000 U once every other week (Q2W) to maintain a     Hb range of 11.5 to 12.5 g/dL (Maintenance Phase) in cancer patients receiving chemotherapy.   "
190942|NCT00337727|"     The study will test aprepitant for the prevention of CINV in patients receiving their initial     cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of     chemotherapy may opt to participate in an optional second cycle during which the patient will     receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant     will be given in place of the oral formulation on study day one. Study drug administration on     subsequent days will be given orally as in cycle 1.   "
190943|NCT00337740|"     Whether beta-blockers or banding is the best therapy for primary prophylaxis of variceal     bleeding is subject to debate. A randomized comparison between the two treatments was     performed in candidates for liver transplantation. Patients with Child B and C cirrhosis with     high risk varices and no previous variceal bleeding are randomized to propranolol or variceal     bleeding. Primary end point is variceal bleeding   "
190944|NCT00337753|"     The purpose of the study is to evaluate a new form of counseling for pathological gambling     and to see if the counseling is more effective than attending Gamblers Anonymous.   "
190945|NCT00337766|"     Patients undergoing cardiac surgery could develop excessive perioperative bleeding requiring     transfusions of blood products.      Desmopressin (DDAVP), already used for patients with von Willebrand syndrome, could reduce     bleeding and transfusion requirements in these patients when administered ev (0.3 mg/kg) in     20-30 minutes postoperatively.   "
190946|NCT00337779|"     Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the     treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA),     a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug     that has anti inflammatory and neuroprotective properties. The study treatment duration is 12     months.   "
190947|NCT00337792|"     The main objective of this study is to determine the equivalency of oral conscious sedation     and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that     oral conscious sedation will be equivalent to intravenous conscious sedation for pain     control. Additional objectives include describing subject satisfaction with each method of     pain control and characteristics of each method such as side effect profile, recovery room     time, and postoperative pain.   "
190948|NCT00337805|"     This is a randomized double blind trial of the use of the use of colloids vs crystalloid     solutions for resuscitation of patients after cardiac surgery. Patients are managed with an     algorithm driven protocol that is based on the flow response to fluid challenges. The     hypothesis is that the use of a colloid solution will result in less use of catecholamines at     8:00 the morning following surgery. Secondary end-points include total use of catecholamines,     time in the ICU, return to the ICU, and safety issues including bleeding and renal function.   "
190949|NCT00337818|"     The study will be extended for subjects who received all three doses of vaccine in Finland,     Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18     vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin     and genitals in men and women. Several types of HPV infection are transmitted by sexual     activity and, in women, can infect the cervix (part of the uterus or womb). This infection     often goes away by itself, but if it does not go away (this is called persistent infection),     it can lead in women over a long period of time to cancer of the cervix. If a woman is not     infected by HPV, it is very unlikely that she will get cervical cancer. This study will     evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified     manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine     safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.   "
190950|NCT00337831|"     Patients will be treated with hemodiafiltration (HDF) in postdilution mode, as a control     therapy, during 9 weeks. During week 5 the 1st intervention treatment, predilution     hemofiltration (HF) or predilution HDF, will be performed as a midweek session. After 4     additional weeks of control therapy the other intervention treatment will be performed.     Samples will be taken during week 4, 5 and 9: from inlet blood flow (0, 30, 60, 120 and 240     min), from outlet blood flow and dialysate outflow (30, 60, 120 and 240 min).   "
190951|NCT00337870|"     This study is designed to assess the effectiveness of the video-based intervention over and     above current standard practice for pain control in the pediatric emergency department (ED).     This is a single-center trial based at the IWK Health Centre. The primary outcome will be     based on the Child-Adult Medical Procedures Interaction Scale (CAMPIS) coding of the     video-taped pain response of the research participants (3-5 years old).   "
190952|NCT00337883|"     This is a Phase II, open-label, multicenter trial of single-agent treatment with Tarceva in     patients with histologically confirmed GBM in first relapse. This study seeks to estimate the     objective response rate and will investigate whether response rate is related to EGFR     amplification status.   "
190953|NCT00337896|"     The purpose of this substudy study is to evaluate the types of cells involved in fighting     infection to the A/H5N1 (avian flu virus) vaccine. A maximum of 30 healthy adults ages 18-64     years, enrolled at Stanford University Hospital and participating in another clinical trial     (DMID Protocol 04-062) will be enrolled into this substudy to collect additional samples of     blood for testing before and approximately one week after each vaccination.   "
190954|NCT00337909|"     The primary objective of this study is to evaluate the design and effectiveness of a     computer-based training program on the memory and cognitive abilities of mature individuals     undergoing healthy aging.   "
190955|NCT00337922|"     This study was designed to explore the drug levels in the blood in Japanese HIV-infected     patients taking EPZICOM tablet at least for 2 weeks prior to administration of the study     drug. Pharmacokinetics after administration of EPZICOM tablet will be investigated in a total     of 8 subjects.   "
190956|NCT00337935|"     The purpose of this study is to show that giving PROCRIT (Epoetin alfa) every 2 weeks to     increase the hemoglobin (Hb) level and then to adjust the PROCRIT (Epoetin alfa) dose every 4     weeks (Q4W) to maintain Hb levels, is safe and effective in patients with anemia from Chronic     Kidney Disease (CKD), not on dialysis, who reside in long-term care facilities. In this study     the frequency of PROCRIT (Epoetin alfa) dosing is under investigation.   "
191363|NCT00351260|"     The study aims to assess whether a SIMPLE or a COMPLEX strategy is best for the treatment of     coronary bifurcation stenoses.   "
190958|NCT00337961|"     The purpose of this study is to develop a way to perform safer surgery in the eye socket. The     eye and its surrounding structures are very delicate and can easily be damaged from surgery.     A laser may act as a gentle knife to cut the tissue. Currently, this is done with a small     scissors and knife, but it could be done with gentle laser. By using an endoscope, the     surgery could be much safer and faster. Vanderbilt has a Free Electron Laser, which could be     used to make a small hole in the coverings around the optic nerve to treat certain diseases.     Before it is used in seeing eyes, the laser must be tested on eyes which are to be removed     during an enucleation to prove that it does not damage the optic nerve The standard     enucleation (removal of your blind painful eye) will be performed. This procedure will be     performed at the Free Electron Laser Center Operating Room, which is a fully equipped     operating room currently being used for outpatient surgery. The post-operative recovery room     setting is similar to the post-operative recovery room in the previously used area. This     includes general anesthesia with a breathing tube in your throat, injecting an anesthetic     liquid behind the eye for comfort after surgery, and removing the eyeball. Enucleations must     be performed under general anesthesia or intravenous sedation with a retrobulbar injection     (injection behind the eye). The anesthesiologist will determine which is safer to perform.     The removed globe will be replaced with a spherical implant. Just prior to the removal of the     eyeball, a small opening will be made in the coverings around your optic nerve (the cable     exiting the eyeball) with the endoscopic laser or with a knife and scissors. The procedure     should not take much longer than the standard eye removal. The procedure will be identical to     the standard enucleation (eye removal) except for making the tiny hole in the coverings of     the optic nerve, which should take about 15 to 30 minutes.      The laser is very tissue specific. It only reacts with certain types of tissue and should not     damage the surrounding tissue.      There will be no additional costs to you associated with the study portion of the procedure.   "
190959|NCT00337974|"     The primary objective of this study is to evaluate the effects of a computer-based training     program on the memory and cognitive abilities of mature individuals undergoing healthy aging.   "
190960|NCT00337987|"     The standard treatment for PTCL is CHOP (cyclophosphamide (C), adriamycin (H), vincristine     (O), and prednisone (P)) chemotherapy. This study is attempting to determine whether adding     other treatments to CHOP therapy will improve the chance of the disease going into remission     or staying in remission. Because other drugs for T-cell lymphoma have not yet been given with     CHOP, this study is looking at combining CHOP with ONTAK. ONTAK has been FDA approved for     treatment of Cutaneous T cell Lymphoma and works by specifically binding to a protein on the     surface of the tumor cells and killing the cell without causing damage to other types of     cells in the body. Studies have shown that ONTAK has helped patients with PTCL who have     failed chemotherapy.   "
190961|NCT00338000|"     The purpose of the study is to evaluate the effectiveness, safety and clinical outcome of     Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the     treatment of anemia in predialysis.   "
190962|NCT00338013|"     You are being asked to participate in this study because we would like to know if sleeping     may affect eye pressure.   "
190963|NCT00338026|"     The purpose of this study was to determine the maximum tolerated dose (MTD) and the     recommended dose for future studies of ECO-4601 administered as a continuous IV infusion for     14 days with 7 days recovery (21 day cycle) in patients with histologically confirmed solid     tumors (high grade glioma, colorectal, lung, breast, ovarian, pancreatic and prostate). This     study was also designed to determine the clinical pharmacokinetic profile, safety of multiple     cycles of administration, and document the antitumor activity of ECO-4601.   "
190964|NCT00338039|"     The primary objective is to evaluate the efficacy of a combination of cetuximab with systemic     chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. The primary     endpoint is actuarial one-year survival.      The secondary objectives are:        -  To evaluate the local tumor response in patients treated with the above regimen.        -  To characterize the safety of the above regimen.   "
190965|NCT00338052|"     This is an non-comparative study. There is no statistical hypothesis. The effects of     extension of treatment on bleeding will be recorded and described.   "
190966|NCT00338065|"     Our experiments are designed to test the overall hypothesis that position-dependent or     water-dependent intra-ocular pressure (IOP) spikes occur in humans, and that these challenge     ocular homeostasis.   "
190969|NCT00338104|"     The primary objective of this study is to determine the optimal dose of glargine insulin when     converting from intravenous short-acting continuous insulin infusions in surgical and     intensive care unit patients using a prospective, controlled, parallel group, randomized     study design.      Note: Lantus insulin is the proprietary name for glargine insulin.   "
190970|NCT00338117|"     The purpose of this study was to determine the safety and effectiveness of a relatively high     dose of galantamine, 32 mg /day in a three-times daily dosage, compared with placebo in     treating patients with Alzheimer's disease.   "
190971|NCT00338130|"     The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with     temozolomide in patients with advanced melanoma   "
190972|NCT00338143|"     This is a Phase IIIb, open label, uncontrolled, multicenter study designed to evaluate the     safety and tolerability of 12 weeks of subcutaneously administered efalizumab in subjects     with moderate to severe plaque psoriasis who are candidates for systemic therapy and may also     be receiving topical therapies, PUVA, or UVB phototherapy during the efalizumab treatment     period.   "
190973|NCT00338156|"     This study will assess the relationship between collagen turnover, neurohormonal activation,     scarring and left ventricle remodelling in patients 3 years following a myocardial     infarction.   "
190974|NCT00338182|"     The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152     when given as a continuous 48-hour infusion every 14 days and as a 2-hour infusion for 2     consecutive days every 14 days in patients with advanced solid malignancies.   "
190989|NCT00339027|"     HealthSpark is a community-based research network of childcare centers designed to improve     the health of children in Miami-Dade County. HealthSpark is the health component of SPARK     (Supporting Partnerships to Assure Ready Kids), a community coalition led by the Early     Childhood Initiative Foundation to improve school readiness in Allapattah/Model City and     Homestead/Florida City, two underserved Miami-Dade County communities. The goal of     HealthSpark I is to identify the health and healthcare needs of preschool children, then help     translate evidence-based intervention into community programs.   "
190975|NCT00338195|"     Recent research has established that some individuals report that they are unable to cease     caffeine use, despite feeling that caffeine is posing a health risk or causing significant     impairment in their daily activities. Despite the high rates of unsuccessful efforts to cease     or control caffeine use in the population, there has been little research on the parameters     of successful caffeine reduction and no research on caffeine cessation.      The goals of the study are as follows:        1. evaluate the applicability of DSM-IV dependence criteria for self-reported problematic          caffeine use.        2. evaluate characteristics (e.g, co-morbid psychopathology) of individuals who report that          they have had difficulty quitting caffeine use on their own and who are seeking          treatment for caffeine use.        3. test the efficacy of a caffeine reduction treatment administered to individuals who          would like to quit/reduce caffeine use, but have found it difficult to do so in the          past.   "
190976|NCT00338208|"     We wish to evaluate a potential training program for patients with glaucoma, to become more     efficient users of prescribed low vision devices for distance and near vision tasks. We     hypothesize that the devices will improve efficiency. Prescribed devices will include a stand     magnifier, a handheld magnifier, spectacle magnifiers for near vision, and a handheld     monocular (telescope) and a bioptic telescope (spectacle-mounted telescope) for distance     vision. The success of being able to use optical devices is dependent upon training. Optical     devices are currently accepted and used for patients with visual conditions that decrease     their central vision. The bioptic telescope is a pair of glasses with a small telescope     mounted within the carrier lens. The glasses look and feel like a normal pair of glasses, but     have a black device (telescope) protruding from the top of one lens for better identifying     distance objects. The spectacle magnifier is mounted in a pair of glasses also for near     vision   "
190977|NCT00338221|"     This is a double blinded randomized clinical trial of Alanyl-Glutamine or Glycine in children     with persistent diarrhea or malnutrition. The primary objective of the study is to determine     the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the     damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in     children at HIAS in Fortaleza, Ce, Brazil, with persistent diarrhea (history > 2 weeks     duration) or malnutrition.   "
190978|NCT00338234|"     Anemia in intensive care and post-operative patients is due to both blood loss (leading to     iron loss) and inflammation.   "
190979|NCT00338247|"     This study will provide pre-approval drug access to lapatinib, in combination with     capecitabine, to patients whose breast cancer had progressed on other therapies   "
190980|NCT00338260|"     The LIFE study was conducted from 1995-2001. This study was conducted in 9193 patients with     high blood pressure and thickening of the main pumping chamber of the heart. The results     showed that after an average treatment time of 4.8 years, treatment that was based on     losartan was better than treatment based on atenolol for reducing the risk of having a     stroke. The main study results were published in Dahlof et al. Lancet 2002;359:995-1003.   "
190981|NCT00338273|"     The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients     with bipolar depression.   "
190982|NCT00338286|"     The purpose of this study is to assess the impact on tumor progression as evaluated by     progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared     with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating     anemia according to label guidance in patients with metastatic breast cancer receiving     standard chemotherapy.   "
190983|NCT00338299|"     The purpose of this study was to test the effectiveness and safety of PROCRIT (Epoetin alfa)     at a higher starting dose (60,000 Units) once per week, followed by a less frequent dose     (60,000 Units every two weeks) in patients with cancer and chemotherapy induced anemia.   "
190984|NCT00338962|"     The purpose of this study is to evaluate the efficacy of naltrexone in combination with an     SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression.      We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in     alcohol consumption than that seen with treatment with SSRI alone, or with a combination of     another class of antidepressant and naltrexone. We also hypothesize that SSRI will be     effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.   "
190986|NCT00338988|"     This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine     (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma,     including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic.     Participants may be either previously untreated or treated with chemotherapy. Participants     will accrue to two strata based on pre-treatment status; separate response rates and     statistical operating characteristics will be applied to each stratum.      The primary objective is to determine the objective response rate (complete plus partial) of     XELOX in this population.      Secondary objectives include determining toxicity, stable disease rates, and median and     overall survival of participants treated with this combination.   "
190987|NCT00339001|"     To evaluate the possibility that erythropoietin with early iron supplementation may induce     retinopathy of prematurity or worsen this disease. In addition risk factors for the     development of ROP will be checked.   "
190988|NCT00339014|"     The purpose of this study is to determine which of seven combinations of Zonisamide CR and     Bupropion SR gives the best weight loss and is safe and well tolerated for the treatment of     obesity not associated with the complications of obesity such as diabetes. In a previous     study, the combination of zonisamide and bupropion SR was shown to be effective for weight     loss compared to either zonisamide, bupropion SR alone or placebo. It is thought that by     adjusting the doses of each drug, giving zonisamide in a controlled release (CR) form and     increasing the doses more slowly, more weight loss and less side effects can be attained.   "
190990|NCT00339040|"     The purpose of this study is to determine the safety of and immune response to a new human     papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between     the ages of 7 and 12 years.   "
190991|NCT00339053|"     The purpose of this study is to determine whether immunonutrition and pre operative nutrition     can reduce lenght of respirator support, lenght of stay in the ICU and incidence of post     operative infections   "
190997|NCT00339131|"     The purpose of this study is to test the safety of a drug called Ultratrace iobenguane I 131     that has radioactivity, to measure how long it takes for the drug to be absorbed and passed     out of the body, and to measure how much radioactivity is absorbed into different tissues of     the body.   "
190998|NCT00339144|"     The primary objective of this study is to determine the maximum tolerated dose (MTD) or the     maximum administered dose (MAD) of Dasatinib (BMS-354825) in patients in Japan.   "
190999|NCT00339157|"     1. Main objective: To test the efficacy of anakinra treatment in children or young adults          with corticosteroid-resistant or -dependent Systemic-Onset Juvenile Idiopathic Arthritis          (SO-JIA)        2. Design: Double blind, randomized trial testing the efficacy of one month Anakinra          treatment versus placebo (2 groups of 12 patients each). All the patients will be          treated with anakinra during the following 11 months and the dose of corticosteroids          will be gradually tapered (= descriptive part of the trial to assess the tolerance and          efficacy over 12 months).        3. Hypothesis: 70% significant improvement after 1 month in Anakinra-treated patients          versus no more than 10% in the placebo group.        4. Main inclusion criteria : diagnosis of SO-JIA (Durban consensus conference criteria),          age: 2 to 20 years at inclusion, active, corticosteroid-resistant or -dependent disease,          no previous IL-1ra treatment.   "
191000|NCT00339170|"     This study will evaluate the effectiveness of a computer-based cognitive enhancement program     plus a work therapy program at improving productivity, work performance, and quality of life     in schizophrenic individuals.   "
191001|NCT00339183|"     The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI     compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.   "
191002|NCT00339196|"     MULTICENTERS. Uncontrolled and open phase II study. Evaluation of the effectiveness of a     treatment associating 5 Azacytidine,Valproic acid ,Retinoic Acid at subjects-reached of     syndromes myelodysplasia and acute MYELOID leukaemia Hematological response at 6 months     Uncontrolled prospective cohort.   "
191003|NCT00339209|"     This study will create a database of clinical and biological research for use in future     studies, with information obtained from lung transplant recipients. The database will consist     of genetic material and clinical outcomes to be used in future genotyping studies, that is,     studies regarding the genetic makeup of individuals. Lung transplantation has become an     important option for patients with advanced lung disease. More than 10,000 patients have     received them to date, and about 1,200 transplant operations are performed worldwide each     year. Although short-term survival has continued to improve, the 5-year survival rate is less     than 50 percent. Most post transplant deaths are directly or directly caused by chronic lung     rejection, a condition of scarring that worsens lung function.      Patients evaluated for lung transplants at Duke University Medical Center may be eligible for     this study.      For developing the database, a small amount of blood, about 3 tablespoons, will be collected     from patients. Blood collection for the research will be done at the same time as blood is     drawn for necessary tests. The blood cells and DNA (which contains genetic material) will be     isolated for analysis. Patients' DNA samples collected will be identified by a code, and all     other identifying information will be removed. Patients may be asked to donate additional     blood samples after their lung transplant if researchers would like to reexamine their blood.      This study will not have a direct benefit for participants. However, during the study, if it     is found that any patients have an inherited risk for a disease likely to cause early death     if the disease is not treated, then the researchers will attempt to notify those patients.     Overall, it is hoped that information gained during this study will help medical     professionals to learn more about immune activation and to see how the reactivity of lung     transplant patients changes over time. If specific genetic risks could be identified, it     might lead to individualized treatments that work on the immune system. Short-term and     long-term survival of lung transplant recipients may thus be improved.   "
191015|NCT00339365|"     This study will evaluate the effectiveness of the Promoting First Relationships (PFR) program     versus an Early Education Support (EES) program in promoting infant well-being, preventing     emotional and behavioral problems, countering developmental delay, and reducing placement     instability in young foster care children.   "
191149|NCT00341211|"     The Viral Epidemiology Branch (VEB) of the National Cancer Institute (NCI) conducts research     on viral infections and their associations with various diseases including AIDS and cancer.     For some research questions, specimens are available from case subjects as part of ongoing     protocols but are not available from normal control subjects (i.e., those without the     infection or disease under study) to whom the case subjects can be compared. This protocol is     to obtain routine specimens (usually peripheral venous blood, occasionally other body fluid     such as saliva, urine, or tears) from healthy volunteers.   "
191204|NCT00349115|"     Multiple Myeloma is a incurable disease. Thalidomide in combination with other agents are     currently in trials for the newly diagnosed patients, we designed treatment of TCD, followed     by high dose chemotherapy with autologous stem cell transplantation and TD maintenance     therapy for the patients with newly diagnosed multiple myeloma.   "
191004|NCT00339222|"     During the course of a case-control study of melanoma conducted at the Bufalini Hospital,     Cesena, Italy in the years 1994-1996, 20 families with 2 or 3 melanoma cases were identified     and studied. The area where the study was conducted showed the steepest increase in melanoma     incidence in Mediterranean populations between the years 1987 and 1997.      Clinical characteristics of melanoma in the families studied were similar to those typically     described in fair-skinned populations, but no relevant mutations in the coding regions of     known candidate genes from melanoma have been found. Lack of findings could be due to the     modest number of families and the small number of affected CMM cases examined. We cannot     exclude the possibility of alterations in introns, splicing sites or promoter regions. Also     epigenetic factors could affect the expression of the gene products we studied.     Alternatively, germline alterations of a gene(s) other than the candidate genes we analyzed     may play an important role in melanoma predisposition in this population. A large number of     families is needed to test these hypotheses.      These additional families could provide an important contribution to the understanding o     melanoma development. In fact, this population does not generally have the host     characteristics that are usually associated with higher risk for melanoma (e.g., light skin     color, red hair, blue eyes, multiple freckles, tendency to sunburn, etc.) but do have a     relative high frequency of dysplastic nevi and melanoma.      The main objective of this study is to recruit more families at the Bufalini Hospital,     Cesena, Italy in order to reach a larger sample size. Recently, 16 potential melanoma-prone     families have been identified through patient's or physicians' referrals by the     Dermatologists at the Bufalini Hospital. The dermatologists have maintained close     relationships with members of these families and are confident that these subjects would be     willing to participate in a study if contacted. The first goal of our study is to contact     this family group and verify their willingness to participate in the study. In addition, new     families could be identified and recruited.      We propose to conduct a pilot project. We estimate recruitment of approximately 25 families     with 2 or more melanoma cases in first -degree relatives over a one-year period, including     the 16 families already identified and approximately 10 new kindreds. At the end of the pilot     phase we will determine the feasibility of continuing recruitment.   "
191005|NCT00339235|"     The aim of this project is to establish a clinical database and a bank of biological     materials which will be used to improve the pathophysiologic understanding of the mechanisms     underlying various pregnancy diseases. The US-Mexico Reproductive Health Research Development     Workshop, sponsored by the NIH, recommended that the setting up of tissue, blood, and     placental banks from human and relevant animal models should be developed to aid in     understanding how prenatal conditions relate to pathological consequences in adult life.      A large observational study in the United States of America, the National Collaborative     Perinatal Project (NCPP), was conducted over 30 years ago (1959-1966) and has yielded a large     amount of useful information. However standards of obstetrical and neonatal care have changed     significantly over the last 30 years. Thus the setting up of a contemporary clinical     perinatal database and bank of biological materials is required. In order to obtain     sufficient data for statistical analysis a large sample size is necessary.      We propose to carry out this project at Sotero del Rio Hospital, Santiago Chile as this     hospital has a delivery rate of approximately 14,000 women per year. Previous research     collaborative efforts between the Sotero del Rio Hospital and the PRB have been carried out     in compliance with NIH research regulations. Sotero del Rio Hospital has had previous     successful negotiations of Single Project Assurances (SPA) with the NIH.      Information will be collected from clinical history taking, physical examination, sonographic     examination and standard laboratory procedures. The bank of biological fluids and tissues     will include maternal blood, umbilical cord plasma, amniotic fluid, maternal urine and     placental tissue. No procedures will be carried out on patients that are not part of standard     of care at Sotero del Rio Hospital.   "
191011|NCT00339313|"     This protocol is for study of the effect of inhibition of parasympathetic outflow on insulin     secretion and glucose metabolism. Insulin secretion will be measured during infusions of     escalating doses of atropine. Other clinical parameters of parasympathetic inhibition by     atropine will also be assessed.   "
191395|NCT00338390|"     The study aims to ascertain whether the sole replacement of tenofovir with abacavir once a     day improves the immunological response obtained with tenofovir + ddI or whether it is better     to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint     formulation) in a single daily dose to achieve these objectives.   "
191006|NCT00339248|"     This study will analyze blood samples to identify substances that are associated with the     development of breast cancer. It will determine if:        -  Women who are diagnosed with a benign breast condition that is related to a considerably          increased risk of breast cancer are more likely to have certain gene variants than women          diagnosed with conditions related to very little increased breast cancer risk        -  Women with benign breast conditions who subsequently develop breast cancer are more          likely to have certain gene variants than women with similar benign conditions who do          not develop breast cancer.      This study will examine blood samples from premenopausal women who underwent breast biopsy     (removal of a small piece of breast tissue for microscopic examination) at four hospitals in     Grand Rapids, MI, from 1977 to 1987 and were found to have benign breast disease. The women,     who agreed to participate in a study of markers for breast cancer, also provided a blood     sample and were interviewed for information on their breast cancer risk factors, family     history of breast cancer, use of medications, and history of medical conditions.      This study will retrieve the biopsy reports for these women, determine which of them later     developed breast cancer, and perform genotyping on their blood samples.      The information from this study may help in future diagnosis and treatment of breast cancer.   "
191007|NCT00339261|"     This study is a continuing follow-up of patients with systemic lupus erythematosus (SLE) and     control subjects enrolled in the Carolina Lupus Study and the University of North Carolina     (UNC) Lupus Nephritis Study. SLE is a severe, chronic, disabling autoimmune disease that     significantly affects health and quality of life. The disease most often affects young to     middle-aged adults, and therefore can also affect work and disability. There is currently     little information on work-related disability related to SLE. The goals of the current study     are to:        -  Determine health and work status of patients and controls in the Carolina Lupus Study          and the UNC Lupus Nephritis Study;        -  Develop and test methods for obtaining disease data from university- and community-based          physicians in the study area;        -  Examine the associations between sociodemographic, work-related factors, disease damage,          and work disability among SLE patients and controls; and        -  Assess the role of demographic and socioeconomic factors, psychosocial attributes, and          potentially modifiable behavior or environmental factors (e.g., smoking, occupational          exposures, medication compliance) in disease damage measures, and in the increased          severity of disease among African-American patients.      Patients and control subjects enrolled in the Carolina Lupus Study and the University of     North Carolina Lupus Nephritis Study are eligible for this protocol.      Subjects will participate in a 30-minute telephone interview that includes questions related     to their current health status, medical care utilization, work and disability issues,     psychosocial attributes (e.g., helplessness, social support), and changes in environmental     exposures since the previous follow-up interview in 2001. With the patients' permission,     disease damaged will be assessed using a standardized form to be completed by the patients'     physician or using information obtained from the patient's medical record.   "
191080|NCT00340301|"     Chemicals called neurotoxins can harm the nervous system. Amyotrophic lateral sclerosis (ALS)     is a progressive disease affecting movement. Researchers have studied many possible causes of     ALS, including injury, diet, and exposure to chemicals, but these studies were inconclusive.      The purpose of this study was to determine whether exposure to lead or other neurotoxins can     contribute to ALS. The study also evaluated lifestyle and dietary patterns. The study was     completed in 1994-1996.      One hundred eighty-two participants took part in this study 110 patients with ALS and 72 who     did not have ALS. Each completed a questionnaire concerning lifestyle, diet, and residential,     job, and medical history. Participants contributed 50 cc of blood, used to measure lead, as     well as clippings of their toenails, used to measure mercury and other metals. They then     underwent an XRF test (an X-ray procedure) to measure the level of lead in their shinbones     and knees. Genes related to ALS or susceptibility to lead exposure were also evaluated.   "
191008|NCT00339274|"     The large number of thyroid tumors that have occurred in areas exposed to high levels of     fallout from the Chernobyl accident raise problems of public health importance, or regulatory     importance, and of scientific importance. The over-riding priority must go to matters such as     diagnosis, treatment of those affected and prevention, and International Agencies are giving     financial and material help in these areas. However providing the needs of the patient are     not compromised, it is very important to ensure that information that may be of value to the     health of future generations is not lost. International agencies are again providing     financial support for a variety of joint studies, some of which are based on studies of     tissues from thyroid operations carried out as part of treatment, and not required for the     initial diagnosis on which treatment is based. An international coordinated approach to this     problem is not in place to help Belarus, the Russian Federation and Ukraine to establish     their own comprehensive thyroid tissue and data banks and to ensure that tissue and nucleic     acids are used to contribute to the understanding of the consequences of the Chernobyl     accident. This project has the support of the Governments of Belarus, the Russian Federation     and Ukraine and the National Cancer Institute of the USA, (NCI), the European Commission     (EC), the Sasakawa Memorial Health Foundation of Japan (SMHF) and the World Health     Organization (WHO) have agreed to cooperate in supporting this project.   "
191009|NCT00339287|"     Human phagocytic cells such as polymorphonuclear leukocytes (PMNs) are readily mobilized to     sites of infection and ingest microorganisms by a process known as phagocytosis. The combined     effects of reactive oxygen species (ROS) and proteolytic peptides and enzymes released into     forming bacterial phagosomes kill most ingested bacteria. However, many human bacterial     pathogens have devised means to subvert normal phagocyte responses and the innate immune     response and cause severe disease.      The overall objective of this study is to elucidate specific features of pathogen-phagocyte     interactions that underlie evasion of the innate immune response or contribute to the     pathophysiology of disease or inflammatory disorders. Therefore, specific projects will:        1. Identify and characterize specific mechanisms used by pathogenic microorganisms to evade          or subvert normal phagocyte responses and therefore cause disease.        2. Investigate phagocyte response mechanisms to specific pathogenic microorganisms.        3. Identify specific bacterial structures and/or (gene) products that dictate differences          in phagocyte responses among a range of pathogens so that generalized statements can be          made about the pathophysiology of disease states.      The studies will be performed using multiple techniques including state-of-the-art equipment     for genomics and proteomics strategies to identify target bacterial genes/proteins of     interest or those up-regulated in phagocytes. Phagocyte-pathogen interactions will be     examined using fluorescence-based real-time assays and video microscopy, confocal and     electron microscopy in combination with enzymatic assays for ROS production, routine     biochemistry, immunology and cell biology.      Implementing these studies will require isolation of phagocytic leukocytes from venous blood     of healthy human volunteers. The study population will be all-inclusive except in certain     instances where individuals possess genetic defects that impair phagocyte function (e.g.,     myeloperoxidase-deficiency) or have altered phagocyte function due to outside influences such     as recent bacterial or viral infection.      The proposed studies will likely provide new information pertinent to understanding host     cell-pathogen interactions and the pathophysiology of inflammatory conditions.   "
191010|NCT00339300|"     The etiology of brain tumors is poorly understood. Due, in part, to public concern about a     postulated relationship between the use of cellular telephones or other increasingly     prevalent environmental exposures and the incidence of brain cancer in adults, the National     Cancer Institute is collaborating with three U.S. hospitals in a comprehensive case-control     study of malignant and benign brain tumors. Factors under consideration include use of     cellular phones and other wireless communication devices, workplace exposures to chemical     agents and electromagnetic fields, dietary factors, family history of tumors, genetic     determinants of susceptibility, home appliance use, reproductive history and hormonal     exposures, viruses, medical and dental exposure to ionizing radiation, and other aspects of     medical history.      Approximately 800 newly diagnosed brain tumor cases and 800 controls have been enrolled at     hospitals in Boston, Phoenix and Pittsburgh. Cases include all adults (age greater than or     equal to 18 years) newly diagnosed with a histologically confirmed intracranial glioma,     intracranial meningioma or acoustic neuroma. Controls are patients admitted to the same     hospitals as the cases, and treated for any of a variety of non-malignant conditions.     Participating cases and controls were interviewed in the hospital by a research nurse and     asked to complete a self-administered questionnaire and donate a sample of blood. Key     features of the study include its large size, the emphasis on rapid ascertainment of incident     cases and interview of study subjects rather than surrogate respondents, the use of detailed,     job-specific questions developed by industrial hygienists to ascertain occupational     exposures, and the storage of blood samples for future evaluation of inherited     susceptibility, biomarkers of exposure and gene-environment interactions.      Implementation of the study protocol proceeded without serious problems. There have been no     harmful effects on study participants. There have been no complaints from participants or     breaches of confidentiality. Continuation of this research involves analysis and reporting of     results. As there will be many papers, this process is expected to extend over the next     several years.   "
197107|NCT00428935|"     The purpose of this study is to determine the safety of a miniature dystrophin gene in the     treatment of progressive muscle weakness due to Duchenne Muscular Dystrophy (DMD).   "
191012|NCT00339326|"     This study will try to identify risk factors for Kaposi s sarcoma, a rare skin cancer, and to     understand the role of the KSHV virus in development of the disease.      All native-born Italians 21 years of age or older residing in Sicily from July 1, 2002     through June 30, 2005 who have Kaposi s sarcoma not related to HIV infection may be eligible     for this study. Healthy control subjects will also be enrolled.      All participants will be interviewed about their childhood, jobs, habits, medical conditions,     and treatments. They also will provide a blood sample and a saliva sample, obtained by     swishing a mouthwash for 45 seconds and spitting it into a container.      Blood will be tested for two viruses KSHV and HIV that are related to Kapsosi s sarcoma. The     KSHV virus is newly discovered and not well understood. In general, a positive KSHV test     probably means an infection with the virus has occurred in the past, but not necessarily that     disease has developed. HIV is the virus that causes AIDS. People with AIDS have a high risk     of Kapsosi s sarcoma. Although HIV and AIDS are very rare among older adults in Sicily, the     presence of HIV must be ruled out in order to understand how KSHV is related to Kapsosi s     sarcoma.      The blood may also be used to measure immunity (the body s defense against infection and     cancer) and for genetic studies to help discover why Kapsosi s sarcoma occurs.   "
191013|NCT00339339|"     This study will determine whether placement of composite (white) dental restorations     (fillings) increases concentrations of bisphenol A (BPA) and its metabolites in saliva and     urine. These compounds have estrogenic-like properties that have raised concerns about their     safety. Small amounts of the chemicals can leach out of dental sealants and be detected in     saliva soon after the sealants are applied. Dental composites also contain some of these     compounds.      U.S. Commissioned Corps officers who need fillings as part of their regular dental treatment     and who select composite (white) restorations instead of amalgam (metal) may be included in     this protocol. Participants are recruited from among officers receiving dental care at the     commissioned officers dental clinic in Rockville, Md.      Participants complete a 15-minute interview to gather information about their recent diet and     eating patterns. They also provide 3 to 4 urine and saliva samples, some collected before     their dental restoration and some after treatment.   "
191014|NCT00339352|"     To advance understanding of environmental, behavioral and genetic causes of brain tumors in     adults, DCEG investigators initiated a multicenter case-control study of malignant and benign     tumors in adults in 1994. This four-year study was conducted at participating hospitals in     Boston, Phoenix, and Pittsburgh. Eligible cases were individuals greater than or equal to 18     years newly diagnosed with an intracranial glioma, meningioma or acoustic neuroma and treated     at one of the participating hospitals. The controls were patients admitted to neurological,     neurosurgical or general surgical services at the same three hospitals for any of a variety     of non-neoplastic conditions. By the end of the study, 811 brain tumor cases had been     accrued.      Information about a broad range of possible environmental, lifestyle, and genetic risk     factors was obtained from both cases and controls through a computer-assisted personal     interview (CAPI). The family history component obtained history and age at diagnosis of     cancer or benign brain tumors and selected other diseases, for all living and deceased first     degree relatives. A supplemental self-administered questionnaire covered diet, vitamin     supplements, alcohol consumption, and household use of electrical appliances. Blood samples     were obtained as a source of DNA. Currently, data analysis is in the early stages.      To increase our ability to examine both genetic and environmental components of brain tumor     risk, we decided to add a family studies component to the case-control study, focusing on     families of glioma cases. Initial contact with each family is made through the cases or, if a     case is deceased, through the next of kin. Cases or next of kin are asked to complete a     Family Health Questionnaire that updates the family medical history and provides contacting     information for all adult first degree relatives and more distant relatives with cancer.     Then, we contact all first degree relatives greater than or equal to age 18 years, and the     next of kin of deceased eligible relatives and invite them to complete a modified risk factor     interview conducted over the telephone. This interview obtains information about each     relative s personal and family history of cancer and other diseases, and history of risk     factor exposures, including all the major categories covered in the case-control study. Study     participants who complete the interview are then asked to provide buccal cells as a source of     DNA for future genotyping.      The glioma cases and their relatives will serve as a unique resource for both epidemiologic     and genetic analyses. Selected relatives can serve as controls for association thereby     eliminating concerns and population stratification. The study design also permits assessment     of specific genetic hypotheses that cannot be evaluated in a traditional case-control study.     Data from all first degree relatives of the glioma cases will be used in association studies     and segregation analysis. In addition, we can screen DNA from members of multiplex families     (families with 2 or more relatives with a primary CNS tumor) for mutations in candidate genes     known to be associated with glioma, and contribute data from selected multiplex families to     collaborative linkage studies to search for new genes conferring susceptibility to brain and     possibly related tumors.   "
191016|NCT00339378|"     Previous studies have estabished pesticide exposure as a possible risk factor for childhood     cancer. The Agricultural Health Study (AHS), a prospective cohort study of pesticide exposure     among 51,000 pesticide applicators in North Carolina and Iowa, provides an opportunity to     study childhood cancer incidence and mortality among the children of pesticide applicators.     Name and dates of birth for 21,985 children were previously provided by adult participants in     the AHS. The current study seeks to identify cases of cancer among these children through     record linkage to state cancer and death registries. Cancer incidence and mortality within     the cohort will be compared with national data through standardized incidence and mortality     ratios. A limited case-cohort comparison of pesticide exposures will also be performed.     Approximately 44 cases of childhood cancer are expected to be identified. No follow-up or     contact with cases is anticipated. It is anticipated that the study results will provide     insight into the relationship of pesticide and other farm exposures to the pathogenesis of     childhood cancer.   "
191017|NCT00339391|"     This project is a collaboration between the Centre Regional de Medecine Traditionnelle (CRMT)     of the Malian National Institute of Public Health Research (INRSP) and the Section on     Socioenvironmental Studies (SSES). These units developed a three-pronged protocol reflecting     their joint and individual concerns:        1. Effects of occupational complexity on psychological functioning. The project tests a          theory derived from previous SSES research demonstrating that in industrialized          societies doing relatively self-directed, substantively complex work increases          self-directed orientations to self, society and family and promotes effective          intellectual functioning. It uses sociological survey methodology to determine the          generalizability of this theory to an essentially pre-literate, preindustrial society.        2. Effects of work-related stress on mental health. Earlier SSES work demonstrated that          stressful work conditions lead to distress in industrialized societies. This project          extends the investigation of these effects to a non-industrialized setting. It also          extends the investigation of work-related stress to include work-related migration,          resting a hypothesis that relates equally to SSES and CRMT concerns: that individuals          from rural ethnic groups with a cultural tradition of work-related migration will show          fewer mental health problems when migrating for nontraditional work than those from          cultures without such a tradition. Mental health problems are assessed through: a)          adaptations of standard survey-based psychological measures of components of distress,          b) general and culture-specific survey-based psychiatric screening questions, and c) a          psychiatric interview conducted by a CRMT psychiatrist trained in internationally          accepted diagnostic procedures and knowledgeable about local cultures.        3. The effects of migration and cultural and socioeconomic factors on AIDS-related          knowledge, attitudes and behaviors. The survey addresses concern regarding the degree of          knowledge about the nature of AIDS among rural Malians who are relatively isolated from          urban oriented sources of information about culturally non-traditional issues. It also          examines how socio-cultural background and migration for work affect AIDS related          attitudes and self-reported behaviors in an African society where estimates of HIV          prevalence are still relatively low (less than 2%), compared to those of other          sub-Saharan African countries.      Although these prongs are distinguishable, each requires a longitudinal design, a     representative sample, extensive information about responders' social and cultural     backgrounds, occupational histories, work conditions, and personal orientations and beliefs.     Because of their overlapping theoretical approaches and methodological requirements,     combining them in one project increases the richness and efficiency of the data collected for     each.   "
191018|NCT00339404|"     In collaboration with members of The International Melanoma Consortium, we propose to study     melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (CDKN2 or     p16) gene, or the cyclin-dependant kinase 4 (CDK4). CDKN2 and CDK4 are both genes that encode     presumed tumor suppressor genes, mutant forms of which are known to cause increased     susceptibility to melanoma. The purpose of the present study then is to confirm the existence     of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular)     and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies.     It is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by     genetic and environmental factors (e.g. sun exposure). Characterization of such genes could     provide important insights into the inheritance, pathogenesis, and treatment of this     increasingly important disease.   "
191117|NCT00340782|"     This study will explore the influence of social and environmental factors, such as stress,     nutrition, health status, etc., on women's reproductive function.      Married Mayan women 16-42 years of age who live in the rural highlands of Guatemala and who     have given birth to at least one child are eligible to participate in this study.      Participants are interviewed about their demographic, social, family, personal, health,     reproductive and economic situations. They have saliva and urine samples collected three     times a week for up to 1 year. Their nutritional and health status is assessed monthly.   "
191019|NCT00339417|"     This study, conducted in Mali, West Africa, will determine whether a new treatment regimen     for lymphatic filariasis can eliminate the disease more quickly than the standard regimen.     Lymphatic filariasis is caused by infection with very small filarial worms called Wuchereria     bancrofti that are spread by mosquitoes. The disease can cause swelling of the arms, legs,     breast and genitalia and can progress to permanent swelling of the legs or arms called     elephantiasis. Currently, patients in Mali are treated with a single dose of 400 mg of     albendazole plus two doses of 200 mcg/kg of ivermectin each year. This study will use a     regimen of 800 mg of albendazole twice a year plus 200 mcg/kg of ivermectin twice a year for     2 years. The study will see if the new regimen is more effective in lowering the numbers of     Wuchereria bancrofti in the blood and will examine the effects of the two treatments on the     adult worms living in the lymph system.      Healthy people between 14 and 65 years of age who live in the Mali village of N'Tessoni and     are infected with Wuchereria bancrofti may be eligible for this study. Candidates are     screened with a medical history, a brief physical examination and blood tests to check for     infection with Wuchereria bancrofti and to measure white blood cell counts.      Participants undergo the following procedures:      -First visit      Ultrasound examination to look for filarial worms in the body.      Random assignment to receive either standard treatment or the experimental regimen      Urine pregnancy test for women of child-bearing age.      Receive first treatment dose.      -6-month visit      Short history, physical examination and blood test.      Second treatment dose for subjects in experimental treatment group.      Urine pregnancy test for women of childbearing age.      -1-year visit      Short history, physical examination and blood test.      Second or third treatment dose, depending on treatment group.      Repeat ultrasound in subjects whose first ultrasound detected adult worms.      Urine pregnancy test for women of childbearing age.      -18-month visit      Short history, physical examination and blood test.      Fourth treatment dose for subjects in experimental treatment group.      Urine pregnancy test for women of childbearing age.      -24-month visit      Short history, physical examination and blood test.      Repeat ultrasound in subjects whose first ultrasound detected adult worms.      Urine pregnancy test for women of childbearing age.   "
191020|NCT00339430|"     Since the beginning of the HIV/AIDS epidemic, the number of women infected with HIV has     rapidly increased and is continuing to climb. The Women's Interagency HIV Study is being     conducted in several cities in the United States to learn more about how HIV affects women's     lives and bodies. It will examine the role of HLA and killer immunoglobulin-like receptors     (KIR) in HIV and related infections in HIV-positive and HIV-negative women. The study will     determine the relationship between KIR and HLA genes and the following: the risk of HIV     infection; HIV levels in the blood; incidence of AIDS; response to highly active     antiretroviral therapy (HAART); and response to immunotherapy.      Approximately 3,700 women will participate. Participants will visit the clinic every 6 months     for 4 years. An HIV test will be given each time to HIV-negative women. A questionnaire will     also be administered. A physical examination and gynecological examination will be given.     Blood, vaginal swabs, and urine will be collected for testing. A biological impedance test     will determine any changes in weight, waist-to-hip ratios, and breast and total body fat. Low     CD4 counts and hospitalizations for HIV are to be self-reported to study staff.   "
191205|NCT00349128|"     The primary objective was to assess the effect of 3-month treatment of low and standard doses     of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels     in patients with type 2 diabetes and dyslipidemia.   "
191021|NCT00339443|"     We propose to conduct a pilot study among 30 volunteers from the Division of Cancer     Epidemiology and Genetics (DCEG) in order to: (1) select the urine pH strip that most closely     correlates with urine pH measured by pH meter for the New England Bladder Cancer Study, (2)     calibrate the urine pH strip that was used for the Spanish Bladder Cancer Study against pH     measured by a pH meter, and (3) compare the DNA yields from buccal cells obtained from two     different methods: mouthwash vs toothbrush-rinse method. Information collected from this     pilot study will be used to select and optimize the sample collection protocols in the New     England Bladder Cancer Study. At the time of enrollment, study participants will be asked to     provide information on age, gender, height, weight, consumption of antacids and calcium     supplements, and whether they ate, drank or brushed their teeth in the last hour previous to     the buccal cells ample collection. In addition, they will have to measure their urine pH with     four different pH strips twice a day (early morning and before dinner) for a week and record     the measurements in a diary. During the same week, they will be asked to collect two spot     urine samples each day from Monday to Thursday (early morning and before dinner), and one     more on Friday morning, and bring them into work in a cooler. Also, they will be asked to     collect a continuous 24-hour urine sample during one of the three first days of the week.     Urine samples will e picked up by lab personnel from BioReliance, and pH will be measured at     their laboratory with the four pH strips again and with a pH meter. Buccal cells sample     collection will be completed during the first and the last day of the urine sample collection     period. The first day, study participants will be asked to provide a water rinse sample after     brushing the inside of their cheeks with a toothbrush, and a week later they will be asked to     provide a mouth wash sample consisting of two consecutive rinses with Scope mouthwash. All     samples and questionnaire data will be unlinked from personal identifiers after the sample     collection is completed. Participants will be compensated with $100 for the inconvenience of     participating in this complex study and for their time.   "
191022|NCT00339456|"     Although highly active antiretroviral therapy (HAART) has been successful in suppressing     plasma HIV RNA levels and providing significant clinical benefit in infected patients, it     does not eradicate HIV infection. It is now clear that virus replication persists despite     undetectable plasma viremia in individuals receiving HAART. In this regard, withdrawing     HAART, even after prolonged periods of virus suppression, leads almost invariably to a rapid     rebound of plasma viremia. It is also now clear that prolonged, continuous HAART carries a     risk of significant toxicity and side effects. In addition, the monetary cost of HAART is     prohibitive for many individuals and countries. In terms of cost, 95% of the HIV-infected     individuals in the world are beyond the reach of therapy as a direct consequence of the cost     of therapy. These observations may argue for a different approach to HAART with the goals of:     1) durable suppression of virus replication, without an attempt at eradication, 2)     minimization of toxicity and side effects and improvement in patient life-style, and 3) a     reduction in cost. Preliminary data from a pilot study conducted at the National Institutes     of Allergy and Infectious Diseases, USA, have demonstrated that short cycle structured     intermittent therapy, 7 days HAART drug followed by 7 days off HAART has maintained     suppression of plasma HIV RNA while preserving CD4+ T cell counts for up to 80 weeks. In     addition, there was no evidence for increased HIV in reservoir sites; nor was there evidence     for the development of resistance to antiretroviral drugs. Finally, there was a decrease in     parameters of toxicity. This approach may have particular applicability for the treatment of     HIV in the Southern Hemisphere. Therefore, we propose to study the virologic and immunologic     effects of short cycle intermittent versus continuous HAART in HIV-infected individuals from     the JCRC (Kampala, Uganda) in a randomized, controlled, intent-to-treat trial. We shall     evaluate both the 7 days on-HAART/7 days off-HAART as well as a 2 days off-HAART/5 days     on-HAART approach. In December, 2004, the 7/7 arm was discontinued.   "
191023|NCT00339469|"     This study, sponsored by the National Cancer Institute and Penn State University, will     examine how a diet high in legumes (dried beans) influences risk factors for colon cancer and     polyps. Many scientists believe that colon and rectal cancers develop from polyps (tumors of     the lining of the large bowel). This study will test whether a high-legume diet can reduce     levels of certain factors (blood insulin, blood glucose, and markers of inflammation such as     C-reactive protein) that at elevated levels are known to increase the risk of colorectal     polyps and colon cancer.      Healthy men between 35 and 75 years of age may be eligible for this study, conducted at Penn     State University in University Park, Pennsylvania. Candidates are screened with blood tests     and measurements of height, weight, and blood pressure. All candidates must have had a     colonoscopy within 2 years of entering the study. They may or may not have had adenomas and     may or may not be insulin-resistant. Candidates must not have cancer, heart disease, kidney     disease, diabetes, or other serious medical condition, and they must have no history of     colorectal cancer, polyp removal, bowel surgery, polyposis syndrome, or inflammatory bowel     disease. Participants undergo the following tests and procedures:        -  Caloric requirement testing: The subject's resting metabolic rate is measured while          fasting and in the early morning at rest to determine daily calorie requirement before          beginning the study diet. A special clear plastic hood is placed over the subject's head          while his breathing is measured. He can communicate with the technician at all times          during the 30-minute test.        -  Study diet: Subjects follow two required 4-week diets with a 3-week break in between,          followed by an optional third 4-week diet. Subjects eat a healthy American diet for both          of the required 4-week diet periods; about 1-1/2 cups of cooked legumes, such as pinto,          baked, and navy beans are added to one of the two required diets. For the third          (optional) diet period, subjects are given the same 1-1/2 cups of legumes, but are          allowed to lose weight. Participants are given packages with all of the food they are to          consume during the three diet periods. They may add up to five caffeine-containing          beverages per day and up to two alcoholic drinks per week. They must eat all of the food          they are given and only the food they are given. Subjects are expected to maintain a          constant body weight during the two 4-week required diets, and their caloric intake may          be increased or decreased as needed to maintain their screening weight.        -  Weight measurements: Subjects are weighed regularly at the clinic.        -  Blood samples: Subjects have blood samples drawn at the mid-point of each of the two          required 4-week diets and at the beginning and end of each of the three 4-week diets.        -  Urine and stool samples: Urine and stool samples are collected at the beginning and end          of the two required 4-week diets.   "
191438|NCT00338949|"     This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a     standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess     abdominal fat storage in people with schizophrenia who are at risk for diabetes.   "
191024|NCT00339482|"     This project is a continuation of an extensive longitudinal population-based epidemiological     investigation of the etiology and determinants of type 2 diabetes (and its complications) and     formerly arthritis. The original baseline observations were made on the residents of the Gila     Indian Reservation, predominantly Pima Indians, in 1965. We attempt to reexamine the     population at two-yearly intervals, and have continued to recruit new respondents who,     because of age and residence or familial relationships, become eligible for entry into the     project. Eligible persons receive a battery of standardized examinations related to diabetes     and its complications at two-yearly intervals, including a glucose tolerance test,     biochemical determinations, such as serum cholesterol and creatinine, insulin, etc., a     physical examination, and in those aged 15 years and above, retinal photographs, and an     electrocardiogram. Persons known to have diabetes will be asked to undergo the examination at     annual intervals to enable more complete and accurate documentation of their health status     and to identify the development and progression of complications of the disease.      The data collected have been used to describe the natural history and determinants of     diabetes and its complications, to investigate factors relating to the etiology of these     diseases and investigate the genetics of diabetes, its complications and other phenotypes. In     addition, the project serves to identify subjects with specific characteristics for the     clinical research projects carried out by the Obesity and Diabetes Clinical Research Section     and the Diabetes Epidemiology and Clinical Research Section fo the Branch.   "
191081|NCT00340314|"     Background: Circumferential pulmonary vein ablation (CPVA) has been safely and effectively     performed for treating paroxysmal atrial fibrillation (PAF); however, its safety and     efficacy, as compared with those of antiarrhythmic drug therapy (ADT), have never been     formally assessed in a randomized controlled trial.      The Purpose of this study was to evaluate CPVA versus ADT in patients with PAF in a     randomized controlled trial.   "
191082|NCT00340327|"     The purpose of this study is to evaluate the safety and drug levels for single, ascending     doses of IMA-638 in healthy Japanese subjects.   "
191025|NCT00339495|"     The Division of Cancer Prevention and Control (DCPC), under extramural contracts to 10 U.S.     clinical centers, is evaluating the effectiveness of screening for prostate, lung, colorectal     and ovarian cancer (The PLCO Trial). The NCI Executive Committee approved the expansion of     the PLCO Trial to collect additional materials and to conduct additional studies. About     74,000 men and 74,000 women, aged 55-74 years, are being randomized on a 50/50 basis into     screening or usual care arms. Additional blood will be collected from screened subjects and     saliva for buccal cells from control subjects. Pathologic tissues will be obtained for cases     that develop cancer or selected related diseases (e.g., colon polyps, benign prostatic     hyperplasia). Additional questionnaire-based risk information will also be collected.     Genetic, biochemical and questionnaire-based risk information will be related to the     development of cancer and other diseases in this population. Volunteers who provide samples     for these studies will not routinely receive their individual results from the Additional     Investigation. Subjects requesting such information, however, will be provided their test     results. This protocol Review Application is for the collaboration of intramural scientists     in the Division of Cancer Epidemiology and Genetics (DCEG) in the Additional Studies.   "
191026|NCT00339508|"     The researchers have developed and distributed several software packages for pedigree     analysis (FAST, CASPAR, PedHunter, IIC) and cancer genetics (oncotree, METREX). Users who     need assistance with the software or who want to see new features added often send the     researchers data files that include human data. The information is normally coded, and the     researchers do not have access to the identification of the people whose information is in     the files. Sometimes the content of the files gives rise to collaborations between the     software developers and the providers of the files. Because concerns over the confidentiality     of medical information have increased significantly over the past few years, the researchers     must apply for exemptions from detailed ethics committee oversight for every data set they     receive. This process is cumbersome and makes it difficult to assist software users. The     amount of information required to apply for an exemption also poses a barrier to     collaborations.      A full protocol will subject all data sets to ethics committee oversight without the need for     individual exemption requests, enabling the researchers to assist users with software     problems and to collaborate with other researchers.      From January 1, 2000, through December 15, 2001, the researchers received 71 requests for     assistance, 19 of which included data files. None of the data files had any names or patient     identifiers. Of these 19, in 8 cases the researchers sent back modified output files. In two     of these eight cases, the researchers could see results of research interest; one of them     concerned human data. In 2 of the 19 cases, the researchers sent back modified input files;     in one such case, they established a collaboration with the originator of the files. In sum,     most requests come under the heading of customer service, with no research contents. A few,     however, do lead to research results or collaborations, for which ethics committee oversight     is required.      Over the three-year time frame of this protocol, the researchers anticipate receiving data on     a maximum of 10,000 individuals. They have modified their software documentation to     explicitly instruct users to make sure the data files they send have no names. Should they     receive files with names, they will delete the files and ask the originator to resubmit them     with names encoded. Users submit data through unencrypted e-mail. The data are stored in     password-protected computers at the National Institutes of Health.   "
191027|NCT00339521|"     We propose to add a collection of genetic material to a clinical trial of anti-oxidant     supplementation for the amelioration of asthma in 7-12 year olds being conducted at a public     pediatric hospital in Mexico City. The anti-oxidant study has been approved by the     Institutional Review Board of the National Institute of Public Health in Mexico City and is     scheduled to begin in September 1998. The purpose of this add-on study is to examine genetic     polymorphisms that may be related to asthma. Asthma cases will be compared with their parents     as controls. In partaicular, we will save the buffy coat from the blood collection being done     on the asthmatic child for measurements of plasma micronutrients in the anti-oxidant trial     for extraction of DNA. This part of the sample would otherwise be discarded. In addition, we     will enroll the parents of the asthmatic child as controls for the child. From the parents,     either a 10 ml blood sample or if they prefer, a sample of buccal cells will be collected.     Although our current plan is to compare the asthmatic child to the parents using statistical     methods based on the transmission disequilibrium test because research into various family     designs for candidate gene studies is rapidly evolving and various sibling control sample     strategies have been discussed, we would also like to collect a genetic sample on as many of     the child's siblings as possible with priority given to those closest in age. This will     enhance the future usefulness of the samples. We anticipate enrolling approximately 200     families.   "
191028|NCT00339534|"     This study, conducted at Korle-Bu Hospital in Accra, Ghana, will help elucidate the roles of     lifestyle and genetic factors in prostate cancer risk. There is a strong variation in risk of     prostate cancer throughout the world. The rates of the disease among African Americans are     some of the world s highest. In the United States, the incidence of prostate cancer is 70     percent higher in African Americans than in white Americans and the death rate in African     Americans is almost double that of white Americans. The reasons for this excessive risk are     unknown, but both genetic and lifestyle factors have been suggested.      Because Africans and African Americans share similar genetic ancestry but have vastly     different lifestyles, a better understanding of the rates and risk factor profiles for     prostate cancer among Africans will provide important clues to what causes the disease. This     study will try to assess the incidence of prostate cancer in the West African nation of     Ghana. The study has two components:        -  Clinical survey The methods of diagnosis at Korle-Bu will be evaluated and the incidence          of prostate cancer over a 5-year period will be estimated.        -  Screening and detection survey A survey of 1,000 men between 50 and 74 years of age will          estimate the prevalence of both asymptomatic and undiagnosed symptomatic prostate cancer          in the Accra population.      The clinical survey will use data from the cancer logbook and medical records at Korle-Bu     Hospital and the Ghanaian National Census to derive an estimate of prostate cancer incidence     within Accra. The estimate will be low, since it will be based only on men diagnosed or     treated at Korle-Bu and will not include men with asymptomatic disease, men diagnosed     elsewhere, or men without access to medical care. The screening and detection survey will     assess the presence of asymptomatic and unrecognized symptomatic prostate cancer using PSA     testing and digital rectal examination in a random sample of 1,000 men in the general     population of Accra. This will provide a high estimate of disease prevalence. The two     estimates will provide an approximation of the true incidence rate of the disease in Accra.      Comparison of these data with similar data from community surveys of African Americans will     provide insight into reasons for the excess risk of prostate cancer in African Americans.   "
191029|NCT00339547|"     The proposed study is designed to estimate the proportion of 35-49 year-old women in a large     urban health plan who have had fibroids. The membership of the health plan is approximately     45% black, so estimates for black and white women can be compared. Risk factors for the     condition will be studied, and uterine tissue from women having hysterectomies or     myomectomies will be studied to identify genetic, hormonal, and protein mediators of tumor     growth.      A randomly selected sample of about 1800 women age 35-49 who are members of the George     Washington University Health Plan will be invited to participate. Presence of leiomyomas for     premenopausal participants with no prior diagnosis of leiomyoma will be determined by an     ultrasound examination. Presence of leiomyomas for premenopausal women who report a prior     diagnosis of fibroids will be determined by ultrasound evidence in their medical record when     available, and by self-report when not available. History of fibroids in postmenopausal women     will be based on pathology records for those with surgical menopause and on radiology records     or self-report for the small number of naturally postmenopausal women. Estimates of the     proportion who have or have had fibroids will be compared for blacks and whites.      To examine risk factors for leiomyoma we will conduct a case-control analysis. Cases will be     those women identified with leiomyoma from the random sample, supplemented by women in the     same age range who have hysterectomies or myomectomies during the study period and hose     excised uteri show evidence of fibroids on standard pathology examination. Women from the     random sample with ultrasound or pathology evidence showing no uterine fibroids will     constitute the control group. Controls will be compared to cases grouped by size of largest     fibroid and grouped by clinical.      A telephone interview and self-administered questionnaire will provide information on     demographic factors, medical history, dietary intake, reproductive history, life style     factors, and occupational/environmental exposures. Blood will be collected from premenopausal     women to measure lipids, insulin, and potential susceptibility genes. Urine will also be     collected from premenopausal women early in their menstrual cycles to measure gonadotropin     levels. Blood pressure, heart rate, weight, height, and waist-to-hip ration will be measured.     Tissue from surgical specimens will be use by collaborators at NIEHS to measure cell     proliferation and apoptosis, genetic factors, estrogen and progesterone receptor levels,     protein markers of estrogen action, and growth factors.   "
191030|NCT00339560|"     The key aims of this study include estimation of possible risk associated with a history of     gallstones, bacterial infection for the biliary tract, other medical history, diet, use of     tobacco and alcohol, obesity, reproductive factors, and family history of cancer. Information     will be used to examine risk patterns a) seperately by anatomic subsite; b) among patients     with gallbladder cancer vs. controls undergoing cholecystectomy for gallstones; c) among the     patients with bile duct cancer vs. Hospital controls without cancer who undergo surgery for     removal of bile duct stones. We will also attempt to ascertain reasons for cancer who undergo     surgery for removal of bile duct stones. We will also attempt to ascertain reasons for the     rising incidence of biliary tract cancers in Shanghai. Serum collected from all subjects will     be analyzed for estrogens and other hormones, vitamins C and E, cholesterol, and bacterial     antibodies (including salmonella typhi, paratyphi, and escherischia coli). Bile fluid will be     cultured for aerobic bacteria, and gallstones analyzed for color, cholesterol, and evidence     of bacteria infection. A major challenge in biliary tract cancer research is to determine how     cancer risk factors differ from those for gallstones or biliary duct stone disease, since     many people have gallstones (or biliary duct stones) but few develop cancer.   "
191031|NCT00339573|"     We propose to conduct a scientifically valid, descriptive survey to measure the prevalence     and levels of lead in dust, soil, and paint, and the prevalence and levels of various indoor     allergens in floor and bedding dust in the nation's housing stock. The survey strategy is a     population-based, multi-stage area probability sample designed to represent all 50 states.     The survey will include approximately 1000 homes in at least 100 primary sampling units (PSU,     a metropolitan area or cluster of counties). Residents of candidate participant housing units     (HUs) will initially be contacted by a letter to introduce and provide a brief explanation of     the study. A field interviewer will then visit each candidate HU to screen and recruit     eligible units into the study. A short Screening Questionnaire will be administered to an     adult HU resident and an invitation will be extended to those HUs that are eligible to     participate in the study. A field data collection visit will be scheduled for the following     week, at the resident's convenience. The collection visit will be conducted by two member     team (including the same field interviewer that will conduct the screening/recruiting visit)     and will consist of administration of an informed consent form and Data Collection     Questionnaire, completion of home observation forms, collection of interior dust and exterior     soil samples, and conduct of nondestructive paint lead analysis on both interior and exterior     walls. Soil and dust samples will be shipped to analytical laboratories for lead and allergen     analysis. Extensive survey design, procedure, and reporting details are provided in the     National Survey Lead Hazards and Allergens in Housing: Protocol and Sample Design Report     (Attachment A). It is anticipated that this study will provide allergen-specific data     regarding: 1) housing conditions, demographic factors, and climate to facilitate evaluation     of regional, ethnic, socioeconomic, and housing characteristic differences in the indoor     allergen burden; 2) an estimate of indoor allergen exposure in the U.S. population; 3)     baseline data that can be used to stimulate future studies which attempt to correlate     allergen exposure to disease outcome. The study will yield lead hazard data to: 1) estimate     the number and percent of homes with dust and soil lead levels above selected thresholds; 2)     identify sources of lead in dust in housing; 3) permit future analysis of lead hazard control     strategies an costs, including associated policy and regulatory guidelines.   "
191032|NCT00339586|"     Current chemotherapy for advanced non-small cell lung cancer, not amenable for curative local     treatment (surgery or chemoradiotherapy), has a modest life-prolonging effect and can improve     quality of life. There is however no potential for long-term cure for these patients.      Chemotherapy also produces variable and often significant toxicity. Current retrospective     evidence suggests that significant clinical responses can be obtained when patients whose     cancer cells have an EGFR TKD mutation are treated with an EGFR TKI.      The ease of administration and toxicity profile of TKI compare favourably with that of     chemotherapy, even single agents such as for example gemcitabine The present study will     establish the clinical benefit rate of TKI as a first line treatment in patients with EGFR     mutations and thus estimate the proportion of patients who might benefit for a prolonged     period from a treatment with a modest toxicity profile.   "
191033|NCT00339599|"     This study, conducted in collaboration with the Johns Hopkins University School of Medicine,     will explore the genetic influences on susceptibility to atherosclerotic cardiovascular     disease (ASCVD). Atherosclerosis is a chronic narrowing of the arteries caused by an     incremental buildup of fatty substances on the linings of walls of arteries. This study will     examine the role of genes related to the inflammatory process on the incidence of ASCVD and     on levels of chemokines (proteins involved in inflammation).      DNA samples, chemokines levels and relevant clinical data from patients enrolled in Johns     Hopkins's sibling and family heart studies are analyzed for specific gene markers. The     studies include: Nurse Model in Black Families at Risk for Heart Disease; Genotypic     Determinants of Aspirin Response in High Risk Families; and Coronary Disease Detection by     Thallium SPECT and Fast CT. All of the enrolled patients have consented to have their DNA     used for testing of genetic factors that may predict cardiovascular disease and do not     contain patient identifier information.   "
191176|NCT00348179|"     The objectives of this investigator initiated study are to:        1. Determine if and when vascular abnormalities occur during early adolescence        2. Determine if poor diabetic control is related to vascular abnormalities.      The development of vascular plaques and vascular contractility will be assessed through the     use of the SyphmgnoCor equipment.   "
191177|NCT00348192|"     The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it     has on the symptoms of mild to moderate Alzheimer's Disease. SB-742457 is a new treatment     which is thought to increase the levels of certain chemicals in the brain that are often     decreased in patients with Alzheimer's Disease.   "
191034|NCT00339612|"     This is an observational, prospective cohort study to describe the demographic, clinical,     immunologic, and virologic characteristics of HIV-infected children at participating clinical     sites in Latin American countries. Enrollment in this study will consist of approximately 500     HIV-infected children in two cohorts who acquired HIV infection through mother-to-child     transmission (MTCT). The first group will be a static cohort consisting of HIV-infected     children who were five years of age or younger when previously enrolled into the NISDI     Pediatric Protocol. The second cohort will be a dynamic cohort of prospectively enrolled,     HIV-infected children who are five years of age or younger. We will characterize     complications from both the disease and its treatments. Subjects will be evaluated every six     months for approximately five years and assessments of growth, morbidity, disease progression     and mortality will be made.   "
191035|NCT00339625|"     The primary objective of the Poly Prevention Trial (PPT) is to determine whether a low fat,     high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous     polyps of the large bowel. Secondary objectives of the PPT include 1) evaluating the     effectiveness of the intervention program with respect to participant achievement of dietary     goals; 2) examining the relation of dietary change and biochemical markers in blood; and 3)     assessing the impact of the intervention on quality of life indicators.   "
191036|NCT00339638|"     This study will identify chemical and protein markers in the blood of people who carry the     human T-lymphotropic virus type I (HTLV-I), a virus associated with various pathologies,     including an increased risk in adults of a rare and aggressive cancer called adult T cell     leukemia/lymphoma (ATL). The study will also examine differences in these markers before and     after the onset of ATL.      ATL has been reported in every area where HTLV-1 is common, including the Caribbean and parts     of Japan, West Africa, the Middle East, South America, and Pacific Melanesia. Risk factors     for the disease are largely unknown and seem to vary among those affected in different     endemic regions. People who acquire the infection early in life are thought to be at higher     risk than those who are infected later. In Japan, men seem to be at greater risk than women,     but the same is not evident among the black population in the Caribbean and Brazil.      Findings from this study will increase understanding of the cause of ATL and identify     differences in tumor characteristics and the course of disease across geographical areas.      Study subjects are drawn from among participants in eight studies of HTLV-1 carriers,     including the 1) Jamaica Mother-Infant Cohort Study, 2) Jamaica Family Study, 3) Jamaica Food     Handlers Study, 4) Miyazaki Cohort Study in Japan, 5) Nagasaki Cohort Study in Japan, 6)     Japan Public Health Center-based Prospective Study on Cancer and Cardiovascular Disease, 7)     HTLV Outcome Studies in the United States, and 8) GIPH Cohort Study in Brazil.      Stored blood samples previously collected from patients in the above studies who did and did     not develop ATL will be analyzed for immunologic and genetic factors.   "
191037|NCT00339651|"     This study, conducted jointly by the National Cancer Institute and the Kaiser Permanente     Center for Health Research Northwest (KPCHRN) in Portland, Oregon, will lay the groundwork     for a future study to identify precursors of endometrial cancer; that is, conditions that     precede development of cancer of the lining of the uterus. The diagnosis of endometrial     hyperplasia (a condition of abnormal proliferation of endometrial tissue) includes most     precursors of endometrial cancer, as well as many benign conditions. Currently, three methods     of classifying endometrial cancer precursors have been suggested based on endometrial     hyperplasia findings, but it is not known which classification best predicts cancer risk.      This study will examine surgical specimens of hyperplasia and cancer from women diagnosed     with endometrial cancer at least 2 years after a diagnosis of endometrial hyperplasia.     Investigators will estimate the percentage of cases with different degrees of hyperplasia,     and assess the subsequent cancers that developed. This will allow them to rank hyperplasia     lesions according to cancer risk and identify lesions that represent the most immediate     cancer precursors. They will also review patients medical charts for information related to     cancer risk and treatment.      Study participants will include women enrolled in the KPCHRN who are 40 years of age or older     and who were diagnosed with endometrial cancer at least 2 years after being diagnosed with     endometrial hyperplasia.   "
191038|NCT00339664|"     Cancer patients in clinical trials donate various human samples (e.g., serum, plasma, blood,     urine, feces, bile, saliva) for research purposes.      The purpose of this study is to conduct further analyses on these existing samples from     clinical trials that are being performed outside of, but in collaboration with, the National     Cancer Institute.   "
191039|NCT00339677|"     This study will evaluate the structure of error in self-reporting instruments on diet, in     following up the Observing Protein and Energy Nutrition Study (OPEN) conducted in 1999 and     2000. The OPEN study, the largest of its kind, resulted in a wealth of nutritional biomarker     data-measurable indicators of changes in organisms at the level of molecules or cells. A     biomarker could help in understanding how environment and disease are related and about     disease risks. Furthermore, its findings showed that the relative estimates of disease risk     may be weakened by a food frequency questionnaire and a 24-hour questionnaire. Scientists     have long recognized that self-reported information from questionnaires and interviews     contains errors, but there has been uncertainty about the structure of such errors. For the     proposed study, a food record and a food checklist-adjusted food frequency questionnaire will     be compared with the previously used questionnaires, to determine whether the newer study     instruments present less chance of measurement error. The results may provide better tools     for a study on nutritional epidemiology, that is, the incidence and other aspects of disease     and nutrition. OPEN study participants will be invited for follow-up.      Patients who completed the 1999-2000 study who are not currently pregnant or a liquid weight     loss diet may be eligible for this study. The original study recruited men and women 40 to 69     years of age. A letter with summary results from the original OPEN study will be sent to each     of the 482 participants.      Both the Food Record and the food checklist, called the Daily Food List, are instruments to     be given. The Food Record asks the participant to record all foods and beverages consumed.     The Daily Food List asks respondents to write in to the number of times a limited number of     food categories are consumed. In addition, respondents will be asked to complete the National     Cancer Institute Diet History Questionnaire (DHQ), identical to the one that they completed     in the original OPEN study, regarding the previous 12 months. Participants will randomly be     assigned to one of two groups. All will receive four study mailings over a 3-month period:     the DHQ, First 4-Day Food Record (4-day FR), Second 4-day FR, and Booklet of 7-Day Food Lists     (7-day FL), the latter listing selected foods that the participants will mark if consumed on     the reporting day. Study Group A will receive the DHQ, first 4-day FR, second 4-day FR, and     7-day FL. Study Group B will receive the DHQ, 7-day FL, first 4-day FR, and second 4-day FR.     Within 10 days after receiving the DHQ, participants will be called to schedule an     appointment for a 30- to 45-minute visit. Participants will undergo the following procedures:        -  Complete the Physical Activity Questionnaire (by telephone for those who have moved out          of the local area or are unable to attend the visit)        -  Have weight measured        -  Be asked about whether he or she has recently developed certain medical conditions,          experienced dramatic changes in diet, or gained special education in nutrition      The completion time for each instrument in dietary assessment is approximately as follows:        -  DHQ-60 minutes.        -  Each 4-day FR-80 minutes (20 minutes a day).        -  7-day FL-35 to 49 minutes (5 to 7 minutes a day).   "
191040|NCT00339690|"     This study will determine whether use of an in-home test kit results in decreased dust mite     allergen levels in homes of children who are sensitive or allergic to dust mites. Dust mite     allergens come from dust mites - microscopic spider-like animals that feed on house dust.     Dust mites are common anywhere there is dust, such as in carpeting and beds. Some people are     allergic to dust mite allergens and may develop asthma from living near them.      People who live in the Research Triangle Park area of North Carolina who have a child between     5 and 15 years old with a dust mite allergy or sensitivity may be eligible for this study.     Participants must plan to remain in the same house for at least 12 months from the start of     the study. At least half the floor of the child's room must be carpeted.      Participants are given materials on how to reduce dust mite allergens in their home. Study     staff visit participants' homes three times over a 12-month period to ask questions about the     home, home cleaning habits, and participants' experiences with home test kits (see below) for     measuring dust mite allergen. At each visit, staff collect dust samples from the child's     bedroom, the parents' bedroom, and the living room. The dust samples are analyzed in the     laboratory for dust mite allergens and the results are given to the participants at the end     of the study.      Participants are also given four home test kits for measuring dust mite allergen in the home.     At the first home visit, staff instruct the participants on how to use the kits and answer     any questions they may have. The kits are mailed at certain times during the study for the     participants to use to measure allergen and send the results to the study investigators in a     pre-paid addressed envelope.      A control group is given educational materials but no test kits.   "
191178|NCT00348205|"     A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery     treatments for hyperopia and astigmatism.   "
191439|NCT00344604|"     To evaluate the changes in quality of life parameters after LASIK surgery.   "
191041|NCT00339703|"     The purpose of this study is to determine whether serum resistin levels in asthmatics are     elevated. We will recruit subjects from the allergy/immunology clinic with a prior diagnosis     of moderate to severe persistent asthma in addition to subjects being seen for evaluation of     drug allergies. Based on the inclusion and exclusion criteria below, subjects will be placed     into a control and asthma group. Each subject will undergo one blood draw in the main lab at     WHMC, and return a lavender top tube to the allergy/immunology clinic for the EIA resistin     assay. The patient will then have a brief encounter with a physician to determine an up to     date history of asthma symptoms prior to participating in the exhaled NO test. The entire     subject encounter will take place with one clinic visit, and requires no follow up visits as     part of the study. The greatest risk to each subject will be the blood draw, as the exhaled     NO is a completely non-invasive test.      Plasma from each subject will be stored in a –70° freezer for no more than one month. Samples     will be analyzed for resistin levels using an EIA assay run monthly. Mean values from serum     CRP, serum glucose, serum resistin, and exhaled NO will be compared using a students T-test.   "
191283|NCT00350168|"     The purpose of this study is to evaluate the blood pressure lowering effects of a     valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of     stage II hypertensive patients (MSSBP ≥ 160 mmHg).   "
191042|NCT00339716|"     Iodine-131(131I) and other radioisotopes of Iodine are contained in fallout from atmospheric     nuclear weapons tests and are among the radionuclides most likely to be released in a nuclear     reactor accident. In spite of nearly 50 years of experience, the risk of thyroid disease,     especially thyroid cancer, attributable to exposure to 131I remains unknown, although the     carcinogenic potential of x-ray and gamma-ray exposure of the thyroid is reasonably well     known. The available data also indicate that children face greater risks of radiation-induced     thyroid cancer than do adults.      The nuclear power plant accident at Chernobyl released large quantities of 131I and other     radioisotopes of iodine into the atmosphere, contaminating thousands of square kilometers and     exposing millions of people. It is proposed that a well-defined subset of Belarussian     children aged 0-18 years at the time of the accident be examined by well-trained specialists     for thyroid disease at least biennially for up to 30 years. A cohort of 15,000 children has     been identified, all of whom had their thyroids measured for radioactivity during the weeks     immediately following the accident. Under a rigid research protocol these children will     receive complete diagnostic thyroid examinations, including palpation, ultrasound scanning,     thyroid hormone and other laboratory tests, and fine-needle aspiration, as appropriate.     Cancer will be determined by expert pathology examination of tissue. In addition to the     analysis of thyroid radiation measurements made in May-June, 1986, efforts will be made to     reconstruct each person's exposure and to estimate the radiation doses to the thyroid. This     will involve the reconstruction of deposition patterns and environmental pathways of the     radioiodines, and of the location, dietary characteristics, and lifestyle of each person     throughout the exposure period.      The data will be analyzed to evaluate the relationship, if any, between thyroid disease,     especially cancer, and the radiation dose to the thyroid, with emphasis on the dose from     131I. The primary focus will be on dose-response analyses of person-year incidence data with     stratification by sex, age at exposure, geographic area, time, and age at risk. Confounding     factors, e.g., use of potassium iodide (KI) as a prophylactic measure, will be evaluated and     controlled in the analysis, and the uncertainty of the dose estimates will be taken into     account.      In addition to producing risk coefficients for thyroid cancer and other thyroid diseases in     children as a function of sex and age at the time of exposure, it is expected that the     analyses will contribute new knowledge of the carcinogenic effectiveness of 131I in     comparison with that of x-ray and gamma radiation. This information will fill a major gap in     the world's knowledge of radiation effects, and will provide guidance for radiation     protection and public health policies wherever nuclear reactors are in operation.   "
191043|NCT00339729|"     We propose a population-based case-control study among 7000 elementary school children in     semi-rural Johnston County, NC. Teachers will complete a screening form on each child.     Controls will be randomly selected. Mothers of potential cases and controls will be     interviewed by telephone about their child's symptoms of ADHD and exposure history, their     family history of ADHD, and their reproductive and exposure history. Children's shed baby     teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child     Behavior Checklist. School records will be collected. The study goals are to identify risk     factors for ADHD including preterm delivery and childhood lead exposure.   "
191044|NCT00339742|"     This study, sponsored jointly by the National Cancer Institute and the Tehran University of     Medical Sciences, will explore the causes of cancers of the stomach and esophagus (the tube     that runs between the mouth and the stomach) in Northern Iran. This is a unique area of study     for the following reasons:        -  Some of the highest rates of esophageal cancer in the world have been reported in          northeastern Iran 109 cases per 100,000 men and 175 cases per 100,000 women each year          about 40 times higher than the rates of this cancer in the United States.        -  In this area of Iran, unlike most areas of the world, the disease affects more women          than men.        -  Within 300 miles along the southern border of the Caspian Sea, the rates fall to 10          cases per 100,000 people per year.      The high rates of disease in this area, the unique geographic distribution of cases, and the     exceptionally high rate in women make Northern Iran a promising site for studying esophageal     and stomach cancers.      Patients 30 years of age and older who are referred to the upper gastrointestinal disease     Atrak Clinic in Gonbad, Golestan Province, Iran, with suspected esophageal cancer may be     eligible for this study. In addition, control subjects 30 years of age and older with certain     specified diseases will be recruited from patients referred to four hospitals in Gonbad and     to the Taleghani Clinic. After giving informed consent, all participants will undergo the     following procedures:        -  Interviews, including questions about age, ethnicity, education, and other demographic          data; habits, such as tobacco, opium, and alcohol consumption; personal and family          medical history; diet, with special attention to food preservation, cooking methods, and          drinking water; physical activity; occupational and residential history; body          measurements; signs and symptoms of upper gastrointestinal disease; oral hygiene; animal          contact; transfusion history; and family socioeconomic status.        -  Blood draw (15 milliliters, or 1 tablespoon) for genetic and chemical testing for          markers that may predict who gets the disease.        -  Hair and nail sampling to identify minerals or compounds whose exposure may be related          to esophageal cancer.        -  Endoscopy to evaluate the health of the esophagus and stomach. This test will be          performed on all case patients and on control participants who give their permission.          Before the examination, the subject will swallow a liquid that numbs the throat and may          be given a medicine through a vein to promote drowsiness. The subject will then swallow          a tube (endoscope) through which the doctor can look at the esophagus and stomach and          take samples of tissue to look for disease. The tissue samples will be examined          microscopically and will then be stored for possible future genetic or other testing          related to diagnosing or determining the risk of esophageal cancer.   "
191045|NCT00339768|"     The Division of Cancer Epidemiology and Genetics is conducting a collaborative randomized     multi-intervention trial with the Beijing Institute for Cancer Research to evaluate the     etiologic role of Helicobacter pylori, garlic, and certain micronutrients in the multi-step     process of gastric carcinogenesis. The primary endpoint will not be cancer, but rather the     precancerous lesions severe chronic atrophic gastritis, intestinal metaplasia, and dysplasia.     The study is designed to detect a stabilizing or mild decrease in the expected age-related     progression of precancerous lesions over the course of the trial. Thus the trial can be     considered a study of the potential inhibitors of the process of gastric carcinogenesis. The     trial will also provide an evaluation of therapy for H. pylori, including an assessment of     reinfection rates, a critical need for formulating strategies for infection control in China     and other developing countries. Participating in the trial are approximately 3400 adults aged     35-70 who were part of an ongoing survey of precancerous gastric lesions in 13 Linqu villages     in Shandong Province. Linqu appears to be an ideal setting for the trial since stomach cancer     rates are among the highes in the world, precancerous gastric lesions are prevalent, and the     population is stable and well characterized. These individuals will be randomly assigned     (taking H. pylori positivity into account) into 8 intervention groups according to a 2(3)     factorial design. The interventions are: 1) initial treatment of H. pylori infection with     ameprazole and amoxicillin followed by 2) daily supplementation with a combination of     alpha-tocopherol, vitamin C, and selenium; and 3) daily supplementation with garlic extracts.     No serious side effects have been seen from any of the interventions to date. The study staff     will continue to monitor for possible adverse reactions and the population will receive     routine medical care follow-up throughout the course of the trial.      As part of the ongoing study in Linqu, all participants received an endoscopic exam in the     fall of 1994. Repeat gastroscopic exams with biopsies at 7 standard gastric sites will be     conducted during March to May, 1999 and March to May, 2003 to detect early cancers and to     evaluate gasatric mucosal status. The subjects will be categorized according to the most     advanced lesions detected in all biopsies and assigned a severity score. The three major     endpoints for analysis will be: 1) prevalence of dysplasia or cancer 2) prevalence of sever     chronic atrophic gastritis, intestinal metaplasia, dysplasia, or cancer; and 3) average     severity score.   "
191046|NCT00339781|"     This study, conducted at St. Bartholomew's Hospital, London, England, will determine whether     cells passed from mother to offspring during pregnancy increase or decrease the child's risk     of developing type 1 diabetes. Previous research has shown that certain cells that can be     passed from mothers to their children during pregnancy may affect the child's chance of     developing other autoimmune diseases. The cells from the mother may persist in the child's     blood for years after birth and stimulate the child's immune system in such a way that may     either increase or decrease the chance of the child developing diabetes. This study will     determine whether these cells are present in identical twins, where only one of the twins has     type 1 diabetes.      Participants in the British Diabetic Twins Study in England may be eligible to participate.     Of each twin pair in the study, one must have type 1 diabetes and the other must be free of     the disease. The twins' mother must be alive and willing to provide a blood sample. For     female twins only, their children must be alive and willing to provide either a blood or a     buccal cell sample (cheek swab).      Participants undergo the following procedures:        -  Both twins in each twin pair provide a blood sample collected on a single occasion.        -  The mother of each twin pair provides a blood sample collected on a single occasion.        -  Children of female twins provide a single sample from either the mouth or blood. For          children younger than 12 years of age, a cell sample is collected from the inside of the          mouth (buccal) using a toothbrush. The child strokes the inside (cheek) of the mouth          with the toothbrush ten times on each side, spits this into a collection vial,          immediately rinses the mouth with water and adds this rinse to the sample collection          vial. Children over 12 years of age may provide either a buccal cell sample or a blood          sample.   "
191767|NCT00348933|"     Angelman syndrome (AS) is a complex genetic disorder that affects the nervous system. The     purpose of this study is to determine the effectiveness of certain dietary supplements in     treating the symptoms of AS.   "
191047|NCT00339794|"     This study, conducted by the American Academy of Family Physicians (AAFP) and the National     Human Genome Research Institute, will characterize family physicians' attitudes and practices     related to the genetics of complex disorders. As the front line of care for most Americans,     family medicine will have a central role in seeing that new findings in genetics lead to     disease prevention and health improvements. The information gained from this study could be     useful in understanding and shaping the dissemination of genetic medicine in ways that     improve the standard of primary care practice.      Members of the AAFP will be randomly selected from the organization's membership records to     be invited to participate in this two-phase study. The first phase is a web-based survey of     AAFP members. In the second phase, a sub-sample of those who complete the survey will be     re-contacted; half will be members who have enrolled in a year-long web-based curriculum     related to medical genetics, and the other half will be those who have chosen not to enroll     in the curriculum.      Survey questions relate to the physicians' practices, knowledge, and opinions about     implications of genomic medicine. Survey areas include family history taking; opinions about     the future of genetics and family medicine; information about the physician and his or her     practice; and physician's skills, attitudes and knowledge.   "
191048|NCT00339807|"     Human T-lymphotrophic virus type I (HTLV-I) is endemic in southern Japan and the Caribbean,     but disease manifestations differ across geographic regions. Though age, gender, and route of     infection may determine the natural history of this infection, the observed geographic     differences also may, in part, reflect the distinct genetic background of the host as     evidenced by the distribution of human leukocyte antigens (HLA) and the presence of other     environmental factors.      Studies already completed or ongoing have shown notable differences in incidence and     prevalence of HTLV-I associated diseases and underscore the need for comparative studies and     analyses in these areas. This prospective new study of blood donors in Jamaica provides us     with an opportunity to address many hypotheses regarding HTLV-I transmission and pathogenesis     in the Caribbean in comparison with an ongoing cohort study of HTLV-I carriers in Japan.      This study will        -  identify host factors associated with HTLV-I carrier status and HTLV-I pathogenesis.        -  directly calculate the incidence of HTLV-I associated diseases in this population.        -  examine the role of HTLV-I in the pathogenesis of other common infectious agents.      Approximately 5,000+ blood donors who came to the National Blood Transfusion each year will     be screened for HTLV-I serology. Of those who agreed to participate, all HTLV-I carriers and     age-, and sex-matched HTLV-I-negatives will be invited to the University of the West Indies     clinic for a full study enrollment. Study participants will be given a standardized     questionnaire, a full physical examination, and a phlebotomy (25-30 mL), and will be followed     every other year for interim health status and additional phlebotomy. All subjects will     receive an ophthalmologic examination for detection of uveitis and other ocular diseases.     Some subjects will be further referred to a neurologist, hematologist or dermatologist,     according to their signs and symptoms. Approximately 1200 HTLV-I carriers and 600 HTLV-I     negatives will be recruited for a longitudinal follow-up over the next 5-year period. Two     types of analyses will be conducted: comparison of HTLV-I-positive and HTLV-I-negative     subjects, and comparison among HTLV carriers between those with a high level of viral load     and those with a low level.   "
191049|NCT00339833|"     This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine     whether reducing subclinical inflammation lessens insulin resistance in healthy, obese     volunteers. The study findings may lead to new strategies for preventing type 2 diabetes. In     diabetes, blood sugar is higher than normal and can result in serious medical problems, such     as blindness and kidney failure. People with subclinical inflammation-inflammation that does     not produce symptoms, such as fever, pain, or skin redness-are at increased risk for     diabetes. Although the reasons for this are not completely understood, it is known that     subclinical inflammation exacerbates insulin resistance, which is a cause of diabetes.     Insulin is a hormone that helps control blood sugar, and when it does not work properly, the     condition is known as insulin resistance.      Normal, healthy volunteers between 18 and 45 years old with a body mass index of at least 30     kg/m2 and who have subclinical inflammation (determined by blood tests) may be eligible for     this study. Candidates must be non-smokers and must not have an alcohol or drug problem.     Candidates will be screened with a medical history and physical examination,     electrocardiogram, and blood and urine tests. Participants will maintain a standard diet and     undergo tests and procedures during a 14-day inpatient stay at the Phoenix Indian Medical     Center.   "
191050|NCT00339846|"     This study will determine whether all patients with craniofrontonasal syndrome (CFNS) have a     mutation of a gene called ephrin-B1 (EFNB1). CFNS is one of a group of conditions called     craniosynostosis syndromes that result from closure of one or more of the fibrous joints     between the bones of the skull before brain growth is complete. Because of the premature     closure, the brain is not able to grow in its natural shape; instead, there is growth in     areas of the skull where the joints have not yet closed. In CFNS, it results in malformation     of the skull and face. It is known that the EFNB1 mutation can cause CFNS, and this study     will see if the gene change is present in all patients with the disorder.      This study includes patients and family members affected with CFNS. Participants have 1 to 2     teaspoons of blood drawn for genetic studies. A second blood sample may be requested for     further research. Some blood may be used to establish a cell line for later studies. This     involves growing the white blood cells from the blood sample. The cells can be kept in the     laboratory to make more DNA or can be frozen for later use in studies of craniosynostosis.     Patients may also have their medical records reviewed to relate gene changes to clinical     features in CFNS.   "
191051|NCT00339859|"     The Laboratory of Human Carcinogenesis and the Pharmocogenetics Section of the Genetic     Epidemiology Branch will conduct a lung cancer case-control study in Baltimore, Maryland. The     primary hypothesis of the study is to determine if mutagen sensitivity, p53 induction and     apoptosis in cultured lymphocytes will be predictive of lung cancer risk. While there are     some studies that examine mutagen sensitivity, none of these assays has been well-studied in     an epidemiological setting. Because of methodological issues described herein, and the     proposed development of new assays, this study will be viewed as a pilot and therefore     hypotheses generating. The design of this molecular epidemiology study has been specifically     developed to test the reliability and validity of the mutagen sensitivity assay, where a     case-control study is needed to assess the possibility of case bias (i.e., results vary due     to the concurrent presence of lung cancer rather than risk). Importantly, this protocol will     establish a resource that will allow for the validation of these assays and also for the     study of other biomarkers and gene-environment interactions, especially those related to DNA     repair. Th secondary goals of this study are to 1) demonstrate gene-neuro-behavioral     interactions for smoking addiction in controls and 2) assess the relationship of sex-steroid     metabolism an and estrogen exposure to lung cancer risk. Cases will have histologically     confirmed lung cancer and reside in Baltimore an and surrounding areas. They will be     identified through six hospitals in Baltimore. Cases will be recently diagnosed and blood     will be collected prior to chemotherapy or radiation therapy. Because of this requirement to     obtain samples before treatment (or for surgical cases at least two months after surgery), we     recognize that case ascertainment will be reduced, but critical data to assess differences     between eligible and ineligible subjects will be collected through tumor registries. Two     control groups will be used, the first will be hospital-based (frequency matched by age,     gender, race, smoking and hospital) and the second will be population-based (frequency     matched by age-, gender and race). The first control group will allow us to examine risk     factors for lung cancer independent of smoking (odds ration for smoking = 1.0), and the     second will allow the results to be extrapolated to the general population and also will be     used to validate the phenotyping assays. The strategy for recruitment will allow us to     over-sample for women and African Americans, so that after examination of data for the entire     study group, we can assess differences by these subgroups. Cases and controls will receive a     structured, in person interview assessing prior medical and cancer history, tobacco use,     alcohol use, current medications, occupational history, family medical history, menstrual     history and estrogen use, recent nutritional supplements and caffeine intake, and     socioeconomic status. The questionnaire also will include the Fagerstrom index for nicotine     dependence (FTND), Center for Epidemiologic Studies Depression (CES-D) scale, and a modified     version of the Horn-Waingrow Reasons for Smoking (RFS) Scale. The phenotypic markers to be     studied will assess DNA repair with cellular response by using lymphocyte cultures exposed in     vitro to radiation, bleomycin, benzo(a)pyrene-diol-expoxide and N-methyl-nitrosurea and then     measuring induction of chromosomal aberrations, p53 induction and apoptosis. DNA from cases     and controls also will be used for genetic polymorphism analysis of carcinogen metabolism,     and those relating to the dopaminergic system and nicotinic receptors. Tumors from cases will     be evaluated for estrogen and progesterone receptors. The target accrual number of total     subjects will be 1,200 where there will be 100 cases for each combination of gender and race     (Caucasian- and African Americans), matched to 100 each of the hospital-based and     population-based controls.   "
191052|NCT00339872|"     The purpose of this study is to evaluate the safety of, and blood drug levels for, single,     ascending doses of IMA-638 in mild to moderate asthma subjects.   "
191179|NCT00348218|"     This is a pilot study to assess the effectiveness of Neurovision treatment in the improvement     of vision in children being under-corrected and to assess the effectiveness of Neurovision     treatment in slowing down myopia progression in children.   "
191440|NCT00344617|"     To assess the use of Avastin for the management of serosanguinous maculopathy   "
191199|NCT00348478|"     There are no specific trials addressing the benefit of water provision and health education     on prevalence of trachoma and infection with ocular Chlamydia trachomatis over time, despite     considerable effort to provide water resources in trachoma endemic areas. Such information is     sorely needed, to advance the Global Alliance agenda for the Elimination of Blinding     Trachoma. This community-based clinical trial will randomize ten communities in Maradi Niger,     half to receive delivery of water and health education services, and half for delivery of     services at a later date. We hypothesize that the intervention communities will have lower     rates of trachoma and C. trachomatis one and two years after delivery of services compared to     communities without such services. This trial will provide, for the first time, solid     evidence of the effect of such services on trachoma, as well as the added benefit following     antibiotic provision by the Ministry of Health on sustaining reductions in trachoma and     infection.   "
191053|NCT00339885|"     The aim of the project is to positionally clone susceptibility genes for NIDDM. Patients will     be ascertained in Finland from previous health surveys and hospital discharge records.     Approximately 400 affected sib pairs will be collected. Families will be chosen who have, at     most, one parent with NIDDM no history of IDDM. A clinical examination will be undertaken on     family members and blood drawn for DNA isolation. Covariates such as body weight, blood     pressure, lipid levels and urinary albumin will also be measured. The unaffected spouse and     children of a subset of probands will be invited to undergo a frequently-sampled intravenous     glucose tolerance test (FSIGT) to measure parameters of pancreatic function and peripheral     insulin resistance (IR). A number of unrelated elderly non-diabetic subjects will also be     identified to conduct a population-based association analysis.      The FSIGT analysis will be performed in Los Angeles. The DNA will be shipped to Bethesda     where a total genomic scan will be performed using semi-automated fluorescence-based     genotyping technology. Data from Bethesda, Los Angeles and Finland will be sent to Ann Arbor     where parametric and non-parametric methods will be used to analyse both discrete traits such     as NIDDM and intermediate traits like IR.   "
191054|NCT00339898|"     This study will determine whether the results of a test called reverse     transcriptase-polymerase chain reaction (RT-PCR) correlate with clinical outcomes in patients     with Ewing sarcoma, and if they can be used to help identify patients at high risk for     metastasis (spread of the cancer beyond the original site).      This is a companion study to another NCI trial (AEWS0031), which is examining the     effectiveness of an intensified chemotherapy regimen for patients with Ewing sarcoma. The     primary purposes of AEWS0031 are to determine: 1) if chemotherapy given every 2 weeks can     cure more patients with Ewing sarcoma and similar tumors than chemotherapy given every 3     weeks; and 2) if certain biological characteristics of these tumors can predict how well the     chemotherapy will work.      Many, but not all, patients with Ewing sarcoma that has not metastasized can be cured with     standard radiation, surgery, and chemotherapy treatment. Most patients whose tumors have     spread, however, are not cured with standard treatment. A goal of future therapy is to     identify patients at highest risk for metastasis so that they can be given more intensive     therapy, and, conversely, patients at lower risk of relapse can receive less toxic treatment.      Patients enrolled in AEWS0031 are eligible for this companion study. No additional procedures     re required; RT-PCR testing will be performed on blood and bone marrow samples collected for     AEWS0031.   "
191055|NCT00339911|"     Background:      The purpose of this protocol is to establish a centralized repository for the collection and     distribution of samples (either blood, buccal mucosal cells, semen, urine, or nail clippings)     from paid, healthy volunteer donors for in vitro research conducted by NCI Frederick     Investigators.      Objectives:      Research uses of normal donor samples obtained through this protocol will include but not be     limited to genotype analysis, immune function studies, drug screening, vaccine development,     method development, quality control testing of reagents, and the propagation of infectious     agents, including HIV.      Although samples may be used to screen for genetic polymorphisms, this protocol will not be     used to conduct genetic screening, or other types of studies, specifically designed to reveal     information of known clinical relevance or implication. Further, Investigators wishing to     recontact donor(s) for repeated samples when preliminary work has given rise to a research     question of potential clinical relevance will seek IRB guidance on whether a separate,     specific protocol should be initiated.      Eligibility:      Healthy FCRDC employees will be recruited. Potential donors will be excluded if screening     indicates exposure to HIV, HTLV or Hepatitis C virus or Hepatitis B virus infection.      Study Design:      Samples provided to Investigators will be either anonymous or coded, depending on the     specific need.      Codes will be securely maintained and under no circumstances will donor identity be released     to Investigators.      The investigational nature of the studies in which their specimens will be used, and the     risks and discomforts of the donation process will be carefully explained to the donors, and     signed informed consent documents covering study participation and HIV testing will be     obtained.      Donors will receive financial compensation for their time, discomfort and inconvenience     according to an established schedule; compensation for blood donation is based on the volume     donated.      Investigators requesting to participate in the Research Donor Program (RDP) by receiving     samples for research use will be required to submit a written memo of request, briefly     describing the nature of the research and providing assurance that samples provided through     this protocol will be used solely for in vitro research.      Whole blood will be collected by the standard phlebotomy technique of venipuncture of forearm     veins.      Buccal mucosal cells will be collected by use of a sterile swab or brush or after oral rinse.     Semen will be collected by self-masturbation at the donors homes.      Urine and nail clippings can be collected either in donors homes or at OHS.   "
191056|NCT00339924|"     This study will develop a survey instrument to measure primary care physicians' knowledge of     the variation in human genetics, their beliefs about biologic and genetic differences     according to patients' race and ethnicity, and how that knowledge is used in their clinical     decision making.      Genomics research today is such that primary care physicians will be responsible for     translating new genetic knowledge, drug therapies, and single and multiplex genetic testing     into clinical practice.      Physicians who are board certified general internists, including those who practice and teach     in research and teaching hospitals in urban areas of the United States, may be eligible for     this study. Participants will be recruited through invitation and information letters mailed     to leaders of local chapters of physician organizations, through letters and e-mail sent to     qualifying general internists in databases, and through e-mail sent to academic physicians     who practice or teach medicine at medical schools that meet the inclusion criteria. The     number of participants is estimated at 96 in the first phase of the study. The researchers     are especially interested in general internists who provide general and preventative health     care services to patients of various racial, ethnic, and ancestral backgrounds. This study     will use qualitative methods-focus groups and semistructured interviews-and quantitative     methods. Two pilot focus group sessions, with about eight members each, are planned for     Washington, D.C. Other settings for the study are Atlanta, Detroit, Los Angeles, and     Philadelphia. Those locations were selected based on population density, availability of     several teaching hospitals with diverse patient populations, availability of physicians     meeting the study requirements, and the need to address important regions nationwide.      The focus groups will be separated by region and self-identified race-for example, one group     consisting of African American internists from Atlanta and another of white internists from     Atlanta. The facilitator will be a general internist of the same race. Each focus group     session, to last about 90 minutes, will be audiotaped and transcribed verbatim. Data from the     focus groups will be analyzed for themes and phrases, and a scale will be developed to assess     responses. Then the scale will be reviewed by two panels of experts. One panel will be     experts in genetics and human genetic variation, and the other will be social scientists and     survey researchers who are experts in developing surveys. For the semistructured interviews,     two physicians who participated in a given focus group will be invited to participate, based     on their engagement in the discussion and interest in the project. This will be a     face-to-face interview of 60 to 90 minutes. A total of 32 interviews will be conducted. After     the scale is revised, a second pilot study will be done. For that study, 3,500 primary care     physicians will be invited to participate in a web-based survey by using the scale. It is     anticipated that there will be sufficient sample size to examine the properties of the scale.     The proposed timetable for the study is 2 years.      Benefits from participating in the study include participants' increased understanding of     human genetic variation and awareness of how other physicians understand and use race and     ethnicity in their practice of medicine. Also, information gained will be useful to improve     physicians' training. There will be compensation for participation. Each physician will     receive $150, and those who participate in both the focus group and semistructured interview     will receive $150 for each session.   "
191057|NCT00339937|"     A series of studies will be conducted in Sicily by a collaborative team from the U.S.     National Cancer Institute and the University of Palermo to better understand the prevalence     and risk factors for the newly discovered human herpes virus 8 (HHV8) and Kaposi s sarcoma     (KS), which may be a consequence of HHV8 infection. There are four short-term projects:        1. To determine HHV8 seroprevalence in extant, unlinked sera from informative groups,          including homosexual men, persons with sexually transmitted diseases, and in general          population groups, particularly the elderly. In addition, HHV8 prevalence and other          serological studies may be determined among other adults, particularly those who may be          recruited for future studies and those likely to enhance understanding of HHV8 serology.        2. To identify a pediatric syndrome that might be associated with HHV8 infection, HHV8          seroprevalence will be determined in sera from hospitalized children with a wide range          of clinical conditions.        3. To determine HHV8 seroprevalence in various regions of Italy and by HLA Class II groups          that have been linked to increased (HLA-DR5) or decreased (HLA-DR3) risk of KS, using          extant, unlinked sera and data from volunteer bone marrow donors.        4. To conduct a case control study that will identify risk factors for KS among persons who          are infected with HHV8 and who manifest anti-HHV8 latent antibodies.      The results of these projects will be summarized for publication in the medical and     scientific literature and for the design and prioritization of related projects in the     future.   "
191113|NCT00340730|"     America's greatest resource is its youth, but that resource is increasingly threatened by     violence. Recommendations for violence prevention have highlighted the need to focus on youth     and to explore targeted interventions Nowhere is the need greater than in our nation's     capital where the intentional injury fatality rate for youth age 14-19 is higher than any of     the 50 states. This study builds on the CDC-supported project Adolescent Violence: A     Community-Based Strategy which instituted citywide surveillance on injuries, conducted by     researchers at the Children's National Medical Center. In this study, the same researchers     will extend that work by testing an individualized intervention to reduce violent behavior     among a sample of assault-injured youth, age 9-15, who present at the Emergency department     (ED). 196 youths and their families will be included in this randomized trial, with 98     families assigned to the individualized intervention condition and 98 families assigned to     the control condition. Families will be followed for 18 months. To address issues of     attrition over the 18 months that the study follows, approximately twice as many families, or     400 families, will be recruited to participate in the study.   "
191058|NCT00339950|"     The CONCeRN Trial is a multi-center study of asymptomatic women between the ages of 40 and 75     referred to regional military medical centers for routine colorectal screening. The primary     purpose of the main study is to determine the extent to which advanced neoplastic lesions     will be missed if clinicians only perform sigmoidoscopies rather than full colonoscopies as a     screening procedure and to resolve current debate about the significance of sigmoidoscopic     detection of single, small, tubular adenomas (i.e., do they imply greater risk for large     adenomatous polyps or colorectal cancer at other sites beyond the reach of the sigmoidoscope,     or is there no increased risk?). Women enrolled in the trial receive colonoscopy during which     all identified polyps are removed and also during which two pinch biopsies of     apparently-normal tissue are taken. In addition, before the colonoscopy is performed,     patients wil have blood drawn and answer a brief questionnaire on risk factors for colorectal     cancer. The sub-study proposes to add on a more extensive questionnaire to assess dietary and     other lifesyle factors potentially related to colorectal cancer, and to draw additional blood     for assessment of nutritional status and for analysis of genetic polymorphisms related to     colorectal cancer. With the additional information available from these questionnaires and     blood samples, it will be possible to explore the extent to which various dietary and genetic     risk factors are related to colorectal polyps in asymptomatic women of average risk for     disease.   "
191059|NCT00339963|"     This study will use genomics-based technology, such as DNA microarrays, to more precisely     diagnose subsets of lymphoma, leukemia and multiple myeloma patients. There have been many     attempts to classify lymphoid cancers in ways that will be useful for clinical diagnosis and     treatment. Although broad diagnostic categories have been reliably defined, patients within     each category have distinct clinical courses, suggesting that these classifications could be     further divided into molecular (genetic) subtypes. For example, 40 percent of patients with     diffuse large B-cell lymphoma achieve long-term disease remissions following combination     chemotherapy and are apparently cured, whereas the remaining 60 percent die from the disease.     Similarly, some patients with follicular lymphoma develop aggressive disease within a few     years of diagnosis, while others have stable disease over 10 to 20 years. Although the     distinctions in clinical course of these diseases are recognized, there are no studies to     determine the molecular (genetic) basis for this variability. This study will try to define     new molecular diagnostic categories in these diseases and correlate them with clinical     features, including treatment response, disease remission and overall survival following     chemotherapy.      This retrospective study will use clinical data and tissue samples from participating centers     in the Lymphoma/Leukemia Molecular Profiling Project LLMPP). New patients will not be     recruited for this study.      Biopsy materials, including fresh frozen or OTC-embedded lymphoma biopsy material, viably     frozen samples of peripheral blood cells from leukemia patients, and viably frozen samples of     bone marrow aspirates from multiple myeloma patients will be collected from pathologists     participating in the LLMPP. RNA and genomic DNA will be extracted from the tumor samples. A     variety of technologies will be used to characterize the genome of the cancer cells,     including lymphochip microarrays for array-based comparative genomic hybridization; Southern     blotting and PCR for translocation of genes previously implicated in these malignancies; and     PCR and DNA sequencing methods for analyzing base changes in the genome of the cancer cells.     Clinical information from the initial diagnosis to disease relapse will be taken from     existing databases and/or patient charts. Gene expression will be correlated with the     clinical data. If a small number of genes is found to strongly predict clinical outcome,     quantitative RT-PCR assays using the Taqman technology may be developed as an alternative to     DNA microarray analysis.   "
191060|NCT00339976|"     This study is a follow-up to an earlier study that examined the relationship of This study     will examine whether exposure to neurotoxins, such as lead, mercury, solvents, and     pesticides, can contribute to amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's     disease. The cause of this degenerative disease of the brain and spinal cord is not well     understood. Some studies suggest that exposure to environmental neurotoxins may increase its     risk. This follow-up study will examine the relationship of neurotoxin exposure to the     interval between the diagnosis of ALS and death. It will also examine the possible roles of     genetics, lifestyle and dietary factors in the disease. Information on ALS patients     previously enrolled in the study will be used to examine this relationship. No new     individuals will be enrolled in the study.   "
191061|NCT00339989|"     This study, conducted by the National Cancer Institute and the University of Oklahoma, will     look for changes in cervix cells and other samples that may be signs of cervical disease.     Human papilloma virus, or HPV, is a common infection of the genitalia in women that usually     goes away by itself. If HPV infection does not go away, it might turn into cancer of the     cervix, although this is rare. This study will examine why many HPV infections go away and     why a few persist and lead to cervical cancer.      Women 18 years of age and older who are referred for colposcopy (examination of the vagina     and cervix using an instrument with a magnifying lens) at the University of Oklahoma     following Pap smear diagnosis may be eligible for this study. Women will be in one of the     following diagnostic categories:        -  Cancer: Stage 1-2 only.        -  Precancer: Cervical intraepithelial neoplasia (CIN3).        -  HPV-infected: Positive for any of the 13 known cancer-causing HPV types, but not          diagnosed with cancer or CIN3.        -  Normal: Negative for cancer-causing HPV and normal tissue laboratory results.      Participants will undergo the following procedures:        -  Questionnaire: Covers demographic information (such as age, race, ethnicity, marital          status, etc.), pregnancy history, menstrual and sexual history, contraceptive history,          hormone medication history, medical history, smoking history, physical development,          family history, and health care access.        -  Blood test: 2 tablespoons of blood drawn.        -  Colposcopy.        -  Procedure to collect a sample of cervical cells and fluids for HPV testing and research.   "
191062|NCT00340002|"     A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth. This     capability allows clinicians to make prudent decisions regarding antepartum care, delivery     site, and postnatal therapy. Three-dimensional ultrasound is a recent technology that     provides a new way to evaluate the fetus. This technique allows one to scan through a digital     ultrasound volume dataset, visualize organs from different perspectives, measure volumes, and     render anatomical features through computer processing. However, the accurate     characterization of fetal anomalies by this technique must be interpreted in relation to     normal fetal anatomy at different stages of pregnancy.      We are continuing to develop an image reference library of fetal anatomy by identifying key     diagnostic features by three-dimensional ultrasound. A cross-sectional observational study of     up to 1,400 fetuses will catalog a broad spectrum of congenital malformations at various     gestational ages. The protocol will include up to 400 examples of normal fetal anatomy by     three-dimensional ultrasonography.      All cases will be placed into a digital image database. For each anomaly category, volume     reconstructions will be compared to normal anatomy at specific gestational ages. Key     diagnostic findings will be documented and correlated with postnatal outcome. We anticipate     that our results will permit improved diagnostic interpretation of congenital defects     throughout pregnancy.   "
191180|NCT00348231|"     The purpose of this study is to compare whether there is the difference in the effect of     insulin therapy by the number of times of insulin injection.   "
191063|NCT00340015|"     This is a prospective cohort study of diet and cancer in relation to several major cancers,     especially breast, prostate, and colorectal malignancies. The cohort comprises 50-69 year-old     male and female members of the American Association of Retired Persons (AARP). In 1995-6 we     mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members     responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates     that the cohort, both men and women, has the desired wide distributions of percent calories     from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the     initial respondents (with satisfactory data) returned a second questionnaire containing     questions on exposures not assessed in the first instrument.      In terms of field activities, the study has been relatively quiescent over the past year. At     the end of the five-year period of observation, we will mail to cohort members a brief     follow-up questionnaire primarily targeted to endpoint assessment. (Because of cancer     registry lag-time, we do not expect to mail this questionnaire until early 2002.) Follow-up     will be largely passive, through established state registries. The initial questionnaire     mailing will be to AARP members in those states selected on the basis of having registries     with adequate coverage and quality. We will use active follow-up, with record retrieval, for     the small percentage of cohort members who have moved out of the cancer registry areas. The     buccal cell collection pilot study has been completed; over 50% of those pilot study     partricipants who had completed the baseline and risk factor questionnaires returned buccal     cell speciments. Preliminary data from a pilot study of the end point ascertainment procedure     indicate that cohort incidence rates for major cancers, determined from registry data, are     consistent with SEER rates.   "
191064|NCT00340028|"     This study will analyze hormones in early pregnancy. Hormonal changes in early pregnancy     reflect the quality of implantation in the uterus of the fertilized egg, the function of the     corpus luteum (mass of hormone-secreting tissue that forms immediately after ovulation) and     placenta, and the health of the embryo. It will determine the following:        -  Whether early pregnancy hormones vary by characteristics of the mother        -  Whether early pregnancy hormones differ for pregnancies with male or female babies        -  Whether early pregnancy hormones can predict the gestational age (age of the baby during          pregnancy) and the baby's birth weight        -  Hormone activity at the time pregnancy symptoms begin        -  How the contribution of the corpus luteum changes during the pregnancy in different          women      Stored urine specimens collected from women who participated in the North Carolina Early     Pregnancy Study in the 1980s will be used for this study. In addition, to evaluate the     quality of the stored samples, new specimens will be collected from women currently enrolled     in the University of North Carolina's Right from the Start study. Candidates must be white     women not of Latino or Hispanic origin who are between 25 and 35 years of age and who are     planning to become pregnant within a few months' time. They must be non-smokers, have regular     menstrual cycles, no known fertility problems and no major chronic disease.      Urine specimens are analyzed for hormone levels and other changes in early pregnancy that can     be measured in urine. Women providing new urine specimens do the following:      Pre-Pregnancy      The pre-pregnancy part of the study lasts through no more than three consecutive menstrual     cycles. Participants who do not become pregnant after three menstrual cycles end the study at     that time.        -  Have a short interview with a study staff member        -  Complete a daily diary, recording any vaginal bleeding or spotting, health status, and          use of medications, and mail the diary to the study office once a week        -  Use an ovulation testing kit for up to 7 days during their menstrual cycle        -  Call the study staff within the first 24 hours of becoming pregnant      Pregnancy      The pregnancy part of the study lasts about 5 weeks.        -  Continue to complete daily diary records for weekly pickup by staff member        -  Collect urine samples daily and store them in the freezer for weekly pickup by staff          member        -  Have 1 to 2 tablespoons of blood drawn at home weekly for 4 weeks        -  Have a brief follow-up telephone interview around week 12 of their pregnancy      Urine samples are analyzed for hormones such as human chorionic gonadotropin,     estrone-3-glucuronide, and pregnanedrol glucuronide. White blood cells are stored for DNA to     study such things as genes controlling hormone metabolism.   "
191065|NCT00340054|"     RATIONALE: Electric and magnetic fields may increase the risk of cancer. Developing interview     questions that accurately estimate a person's exposure to electric and magnetic fields may     help doctors learn about the long-term effects of workplace exposure.      PURPOSE: This clinical trial is developing interview questions that can be used in estimating     workplace exposure to electric and magnetic fields.   "
191066|NCT00340080|"     Study to evaluate the utility of prospective HLA-B*5701 screening on the incidence of     abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from     Europe, Australia and other countries as applicable. The study has two (co-primary)     objectives: i) to determine if screening for HLA-B*5701 prior to ABC-containing HAART results     in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic     screening) and ii) to determine if screening for HLA-B*5701 prior to ABC-containing HAART,     results in a significantly lower incidence of immunologically-confirmed HSR versus current     standard of care (no genetic screening or patch testing). The study consists of up to a     28-day screening period, a randomised observation period (Day 1 through Week 6) and, for     subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an     epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one     of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control)     and a Genetic Screening Arm (prospective genetic screening). Subjects identified as     HLA-B*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be     excluded from further study. Subjects who experience suspected ABC HSR during the 6-week     observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6     weeks later.   "
191067|NCT00340093|"     This 1-year study will test the feasibility and effectiveness of a diabetes personal trainer     in helping youth with diabetes manage their treatment. It will examine how families with a     diabetic child handle the responsibilities of managing diabetes and deal with the changes     that come with managing the illness as the child grows up.      Children between 11 and 16 years of age receiving treatment for diabetes type 1 at Johns     Hopkins University Medical Center may be eligible for this study. The children must have been     diagnosed with diabetes at least 1 year before entering the study and must require insulin     treatment. One parent of each child will also participate.      On entering the study, each child and parent will be interviewed about various topics having     to do with taking care of diabetes. After the interview, the children will be randomly     assigned to one of two groups: Group 1 will receive education information about diabetes     management; Group 2 will be enrolled in a program in which they meet with a diabetes personal     trainer 6 to 7 times over 2 months for individualized instruction in planning and evaluating     their diabetes care activities. They will also keep in contact with their trainer by     telephone.      Children in Group 2 will be given a hand-held personal computer device in which they will     keep a record of all diabetes-related activities for 3 days, including insulin shots, meals     and snacks. In addition, they will wear an accelerometer, a small device that keeps track of     the amount of movement they make. At the end of each of the 3 days, the child will complete a     20- to 30-minute telephone interview reviewing the day. They will have a tape-recorded     interview about their experiences in taking care of diabetes. Their meetings with the     personal trainer also may be taped.      Children in both groups will continue to see the doctor at the clinic as they normally would.      At 2 and 6 months after starting the study, children in both groups will complete a telephone     interview about diabetes management. At 12 months they will complete an in-person interview.   "
191142|NCT00341120|"     This study is being conducted at the University Hospital of Lund University in Malmo, Sweden,     in collaboration with the U.S. National Institute of Child Health and Human Development. The     study will try to identify genetic causes of impaired sperm production and male infertility.     It will focus on the possible role of the MTHFR and CBS genes, which regulate absorption and     metabolism of the vitamin, folate in infertility. If the nutritional intake or metabolism of     this vitamin is related to male infertility, then this cause of infertility would be     potentially curable.      Fertile and infertile men between 20 and 45 years of age may be eligible for this study.     Criteria include the following:        -  Fertile men: men whose partners are younger than age 40 and are attending Lund          University prenatal clinic; who have fathered one or more pregnancies and who stopped          birth control to achieve the present pregnancy; who achieved the present pregnancy in          less than 12 months of unprotected intercourse.        -  Infertile men: men referred to the Scandian Andrology Centre whose infertility is          unexplained, whose partners are younger than age 40 and who have had regular sexual          intercourse without contraception for at least 12 months without achieving a pregnancy.      All participants will have the following tests and procedures:        -  Complete a questionnaire providing information about their reproductive and medical          history and recent dietary history;        -  Provide blood samples for analysis of red cell folate, plasma folate, plasma          homocysteine, plasma B12, and for genetic evaluation;        -  Provide a semen sample for routine analysis, including volume, sperm concentration,          sperm motility, and sperm morphology.      In addition, infertile men will undergo a physical examination and review of their medical     records.   "
191068|NCT00340106|"     This study will: 1) test the effectiveness of a program to prevent the exposure of infants to     environmental tobacco smoke; and 2) evaluate the health effects associated with prenatal and     postpartum exposure to tobacco smoke products and environmental tobacco smoke among infants.      African-American and Hispanic women who are 18 years of age or older, and who are between 28     and 35 weeks pregnant may be eligible for this study. Participants complete an interview and     home visit assessment and are then randomly assigned to participate in Program A or Program B     of the study, as follows:      Program A: Involves discussions with an Infant Health Advisor about parenting skills to     promote child safety and infant growth and development, such as ways to prevent childhood     injuries caused by falls, poisons, and other hazards.      Program B: Involves discussions with an Infant Health Advisor about ways to prevent infant     tobacco smoke exposure, such as how to adopt smoke-free household rules in the home and how     to work with friends and family members to prevent the baby from being exposed to tobacco     smoke. In addition, participants who smoked cigarettes before becoming pregnant or while     pregnant are given advice on how to quit smoking and how to remain a non-smoker once the baby     is born.      Participants come to the clinic four times- once during a regularly scheduled prenatal visit     and again when the baby is 6 weeks, 4 months, and 6 months old - to see the Infant Health     Advisor for the activities described above in Program A or Program B. Between visits, the     Advisor calls the participant to check on her progress regarding the program objectives. In     addition, the study involves the following for all participants:        -  Telephone interview during the week after joining the study to obtain information on          participant's background, pregnancy and family history, tobacco use and exposure to          other people's cigarette smoke during pregnancy, strategies to reduce tobacco use and          exposure, stressful life events, drug and alcohol use during pregnancy, and sources of          social support. Similar interviews are repeated when the baby is 6 weeks old, and again          when the baby is 4 months, 6 months, and 12 months old.        -  Home visit about 1 week after entering the study to check the home for possible safety          hazards to the baby and to place one or more nicotine air monitors (small plastic          objects that measure the amount of tobacco smoke in the air of each room). The home          visitor returns a week late...   "
191069|NCT00340119|"     This study, done in collaboration with Johns Hopkins University School of Public Health in     Baltimore, Maryland, will examine the role of genes in the development of atherosclerotic     cardiovascular disease (CVD) in patients undergoing kidney dialysis. The rate of illness and     death from CVD among patients on dialysis is extraordinarily high, accounting for about 50     percent of deaths. Blood levels of inflammatory markers are elevated in these patients,     strongly predicting illness and death from CVD. The discovery of gene variants related to the     inflammatory process in atherosclerotic CVD may lead to better medical treatments and     improved survival in patients with end-stage kidney disease.      Participants of John's Hopkins University's CHOICE (Choices for Healthy Outcomes in Caring     for End-Stage Renal Disease) program are included in this study. Blood samples previously     collected from these patients will be analyzed in the laboratory for genes that might be     associated with the inflammatory process and atherogenesis.   "
191071|NCT00340158|"     Inflammatory breast carcinoma (IBC) is an extremely rare, aggressive form of breast cancer     that disproportionately impacts young women. IBC often affects the skin of the breast, as     well as the breast itself, making it appear inflamed. The purpose of this study is to collect     data and information on IBC patients so that researchers can study factors associated with     IBC. The data and information collected will be used to establish the IBC Registry, a private     cancer registry.      Approximately 300 persons who are 18 years or older and who have been diagnosed with IBC will     participate in this study. Participants will provide researchers with access to their medical     and pathology records, slides, tissue, and x-rays. They also will consent to a 15-minute     telephone interview concerning general information about themselves and the initial     manifestation of IBC and to a 30-minute interview about their medical history.   "
191072|NCT00340171|"     Fetal growth abnormalities, such as macrosomia and intrauterine growth retardation, are an     important cause for increased perinatal mortality in the United States. Toward this end,     accurate fetal weight determinations are very important for guiding prenatal care.     Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the     fetus. This technique allows one to arbitrarily scan through a digital ultrasound volume     dataset, visualize organs from different perspectives, and render anatomical features through     computer processing. It also allows the retrospective measurement of distances and volumes     even in the physical absence of the patient.      A maximum of 400 pregnancies will be serially studied by three-dimensional ultrasound to     characterize the growth of volume parameters such as the fetal thigh. This information will     be applied to the Rossavik model of individualized growth assessment. The technique allows     growth evaluation by comparing various ultrasound measurements or birth characteristics to     the individual growth standards specified by the prediction model. Newborn infant body     composition will also be studied within 48 hours of delivery.      A separate cross-sectional study of up to 2,577 fetuses will allow development of birth     weight prediction models based upon fetal volume measurements and further analysis of fetal     growth abnormalities. Individual growth curve standards utilizing these volume parameters     should allow one to evaluate deviations from expected growth or birth weight by using each     fetus as its own control.   "
191073|NCT00340184|"     The purpose of this study is to determine whether post-operative concurrent chemoradiation     with paclitaxel/carboplatin is effective and safe in the treatment of high risk cervical     cancer patients.   "
191181|NCT00348244|"     Evaluate if the incidence of sub clinical CME can be significantly reduced by use of     peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal     cataract patients.   "
191322|NCT00350714|"     The goal of this study is to validate the BreathID 13C-methacetin breath test (MBT) as a     non-invasive simple-to-use metabolic test, which could be utilized to detect severe liver     fibrosis (>2 in METAVIR) in patients with chronic HCV liver disease.The test is a breath-test     using a free-standing device (BreathID®) that measures metabolization of a 13C-labeled     substrate (13C-methacetin) in real time.   "
191083|NCT00340340|"     We will conduct an interdisciplinary case-control/sib-pair study of lung cancer designed to     explore the genetic determinants both of lung cancer and of smoking. The study includes     biospecimen collection as well as exposure information with power to address main genetic     effects and gene-environment interactions.      This is an integrated proposal designed to address two major issues: the genetic determinants     of lung cancer in smokers and the genetic determinants of smoking. Other important issues     will be addressed in the study with a marginal additional cost to the main design. The study     achieves excellent power for studying the main effects of genetic factors that are relatively     common and good power for formal tests of interactive effects.      Using a case-control design, with questionnaire, medical record abstraction, and blood     collection, we will investigate: main effects of genes on lung cancer risk; gene-environment     and gene-gene effects in lung cancer etiology; gene effects on smoking persistence; gene     effects on ever-never smoking; gene-psychological interactions in smoking behaviors.      In addition, we will collect viable lymphocytes from all study subjects and tumor,     metaplastic and normal tissue samples from 100 surgical cases. With these data and tissues,     we will be able to study: genetic instabilities in lung cancer tissue in relation to specific     exposures, genotype, persistence of smoking, and clinical presentation of lung cancer;     histologic characteristics of lung cancer in relation to genotype, gene expression, somatic     mutations, and smoking; functional assays in viable lmphocytes in relation to genotype, gene     expression.      Finally, we will identify lung cancer-affected siblings of cases, and the unaffected siblings     in the same sibships. This sample will permit us to: replicate associations found in the     case-control sample with an alternative analytical method based on transmission statistics;     address some population stratification issues.   "
191200|NCT00349063|"     The purpose of this study is to compare the wettability of contact lenses disinfected with     three marketed contact lens care solutions.   "
191074|NCT00340210|"     The Columbia, MO Serum Bank initially was established in 1977 as part of the National Cancer     Institute's (NCI) Biological Markers Project to identify serum markers for breast cancer.     Participants were volunteers identified through the Breast Cancer Detection Demonstration     Project (BCDDP) at the University of Missouri Hospital and Ellis Fischel Cancer Center in     Columbia, MO. A total of 6,915 women without a prior history of cancer, other than     non-melanoma skin cancer, donated blood to the bank on one or more occasions between 1977 and     1987.      At the time of each blood collection, interview information was obtained including age,     height, weight, reproductive and menstrual histories, family history of breast cancer,     medical conditions, and drug use, including oral contraceptives and menopausal hormone     therapy. Date of last menstrual period was captured for women who were premenopausal at the     time of each blood collection. Approximately 30% of the women donated multiple samples over     the first 10 years of the study, (including 20% with 3 or more samples), with collections     occurring on average one year apart. At each collection, serum was aliquoted into up to ten,     1 ml vials and stored at -70 (Infinite)C at the NCI Repository. All women gave informed     consent before donating to the serum bank.      The initial follow-up continued for up to 12 years through 1989, with 244 cancers identified.     Of the 6915 original participants, 79% were last seen in 1983 or earlier, yielding a median     follow-up time of 4 years. A questionnaire was mailed to all participants annually to     ascertain information on interim breast biopsies and cancer diagnoses. Women who indicated     that they had a breast biopsy or breast cancer were sent a consent form for permission to     obtain medical records including pathology reports. For cancers at sites other than the     breast, medical records and pathology reports were not requested, although date of diagnosis     and site were ascertained.      Between 1999 and 2002, an extended follow-up of Columbia, MO Serum Bank participants was     conducted. Of the 6915 original participants, 6,720 women had blood remaining and were     included in this phase of the study. Of these, 6,154 (91.6%) were located; 566 (8%) were not     locatable, 109 (2%) refused to participate, and 40 (<1%) were too ill to participate. 1,694     women (25%) were deceased. This last follow-up identified an additional 1123 cancers. This     cohort has serum samples from a cohort of 6720 pre- and postmenopausal women followed up to     20 years for cancer diagnoses and is a unique resource for molecular epidemiologic studies     exploring serum markers associated with cancer risk.   "
191075|NCT00340223|"     This study will identify variations in the genome of the human immunodeficiency virus (HIV)     early after infection and following the development of AIDS. It will analyze genetic material     and clinical data from HIV-positive individuals to assess differences in viral epitopes     between patients with two different gene alleles (alternative forms of a gene)-B*3501 and     B*3503. (An epitope is a molecular region on the surface of an antigen capable of eliciting     an immune response and of combining with the specific antibody produced by such a response.)      HIV disease in people with the B*3503 allele progresses significantly faster than it does in     people with the B*3501 allele. This study might provide information that is potentially     useful in developing a successful HIV vaccine.      Blood samples and clinical data for analysis will be obtained from the Johns Hopkins     Bloomberg School of Public Health; the University of Pittsburgh; the John H. Stroger, Jr.     Hospital of Cook County; the Howard Brown Health Center; Northwestern University; and the     University of California at Los Angeles.   "
191076|NCT00340249|"     The purpose of this application is to request permission to use a bank of biological     specimens and clinical information collected by the investigators prior to their joining the     intramural program. The samples have been gathered under the sponsorship and approval of the     Human Investigations Committees at Yale University, Wayne State University and Pennsylvania     Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the     Universidad de Chile and the Universidad Catolica de Chile, in Chile. The investigators     have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained     at the time of delivery (from the umbilical cord and by cordocentesis), neonate's urine and     sonographic examinations of the fetus, including echocardiography, stored on video-tapes.     Clinical information with patient identifiers is available for these samples and sonographic     examinations.   "
191077|NCT00340262|"     Recent cohort studies demonstrated reduced breast cancer risks among women with a history of     fractures or low bone mineral density (BMD). In the Study of Osteoporotic Fractures, each     standard deviation increase in distal radius BMD was associated with a 50% increased risk     over three years of follow-up, while in the Framingham study, women in the highest quartile     of metacarpal bone mass had a 3.5-fold higher risk than women in the lowest quartile. The     impact of the severity and timing of bone loss on risk has not yet been investigated, and the     extent to which other risk factors (family history, anthropometric factors, physical     activity, and exogenous hormones) modify the relationship with BMD is unknown.      To elaborate on these research questions, we are conducting a follow-up study of 22,695     postmenopausal women who volunteered for the Fracture Intervention Trial (FIT), a trial of     the bone-enhancing drug alendronate. This large cohort includes extensive baseline     information on major breast cancer risk factors, and thus is ideal for evaluating potential     interactions with BMD and the effects of BMD on other cancer sites. Endometrial cancer has     been reported to occur more frequently among women with a history of fracture, but no     previous studies have specifically investigated its relationship to BMD.      We are investigating whether BMD of the proximal femur predicts breast cancer risk; whether     breast cancer risk factors among postmenopausal women modify the relationship with BMD;     whether BMD predicts endometrial or other cancers; and whether measurable biomarkers offer     further etiologic clues about BMD and cancer risk.      We have contacted the surviving members of FIT to ascertain incident cancers. Risk factors     and fracture history are being updated through a self-administered questionnaire. To     supplement the serum samples collected at baseline, we are using a nested case-control study     approach to collect buccal cell specimens, which may be useful for measuring a variety of     biomarkers, including endogenous hormones and genetic polymorphisms involved in either bone     growth (e.g., vitamin D receptor) or hormone metabolism (e.g., CYP17, COMT). Retrieval of     operative and pathology reports is being used to validate self-reported cancers. The social     security numbers and contacts names provided by FIT participants when they completed the     baseline questionnaire are facilitating comprehensive follow-up and a National Death Index     search for those who cannot be located. The baseline data, the established cooperation of     this study population, and the collection of additional biospecimens should enable this study     to answer important questions about BMD in breast and endometrial cancers.   "
191078|NCT00340275|"     Bacterial vaginosis is a syndrome manifested by adverse alterations in vaginal microbial     flora. It is present in 10 to 25% of women in the general population, and is the most common     vaginal infection. It has been associated with a number of adverse sequelae in reproductive     health including acquisition of HIV, pelvic inflammatory disease, cervical dysplasia, and     complications of gynecological procedures. During pregnancy it has been associated with an     increased risk of preterm birth an postpartum maternal infection. However, the vaginal     microbial flora remains poorly understood. Information on variation in microbial flora and     its association with BV from a longitudinal study is unavailable. This prospective     observational study aims to advance our knowledge of the natural history and abnormal     alteration in vaginal microbial flora, and to identify risk factors that are associated with     these changes. A total of 5500 healthy, non-pregnant women of reproductive age will be     enrolled and followed up in Birmingham, Alabama, for one year (baseline visit plus once every     three months afterwards, totaling 5 visits). Detailed information on sociodemographic status,     medical history, hygiene practice, sexual behavior and psychosocial stress will be collected     through in-person interviews. Routine gynecological and dental examinations will be carried     out during the study visits. Samples of vaginal secretion and blood will be collected.     Laboratory tests to quantify vaginal microbial flora and to identify infection of bacterial     vaginosis as well as common sexually transmitted diseases will be conducted. This project is     expected to complete in 5 years.   "
191214|NCT00349258|"     To compare the incidence of ovarian hyperstimulation syndrome (OHSS) and implantation rate     between high responder patients using Gonadotropin releasing GnRH) agonist or human chorionic     gonadotropin (hCG) to trigger final oocyte maturation.   "
191084|NCT00340353|"     Background:      Alveolar soft part sarcoma (ASPS) is a rare tumor.      ASPS is resistant to chemotherapy and radiation.      ASPS is characterized by slow growth.      Currently no in vitro or in vivo models of ASPS exist for use in experimental therapeutic     studies or biological investigations.      Primary Objectives:      Acquisition of blood and tissue from patients with ASPS.      Acquisition of blood from healthy controls for comparison with blood from patients with ASPS.     These control samples will be obtained from study NCI at Frederick Protocol OH99-C-N046.      Eligibility:      Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who     are undergoing medically indicated surgery for their disease.      Design:      Patients with Alveolar Soft Part Sarcoma (ASPS) will be eligible for this study. Biopsy     tissue will be obtained as an additional sample at the time of a medically indicated     procedure. Blood sample may be collected at initial visit and follow-up visits. Specific     risks will be described in a separate consent to be obtained at the time of the biopsy. Tumor     samples and blood samples will be processed and/or stored for use in research efforts in the     laboratory of Dr. David Vistica, National Cancer Institute, Frederick, MD. Additionally,     blood samples will be obtained from healthy volunteers for comparison to patients with ASPS.     These control samples will be obtained from the National Cancer Institute at Frederick     Protocol OH99-C-N046.   "
191114|NCT00340743|"     This study will examine the risks and protective effects of dietary factors on temporary     genetic damage to cells lining the gastrointestinal tract and to blood cells. Some foods,     including very well done meat, may increase genetic damage in cells, while others, such as     yogurt and vegetables, may reduce genetic damage. This study may provide new information on     the influence of diet on increasing or decreasing the risk of developing cancer, particularly     colorectal cancer. The study is conducted at the General Clinical Research Center (GCRC) of     the University of North Carolina.      Nonsmoking, English-speaking, healthy adults between 18 and 45 years of age may be eligible     for this 4-week study. Participants undergo the following tests and procedures:        -  Interview: Participants complete questionnaires including information on their diets,          habits, past and present health, and family histories.        -  Diet: Participants adhere strictly to the diet provided by the dietician at the GCRC for          all 4 weeks of the study. All meals are provided by the GCRC. All meals contain          well-done meat and some contain yogurt, cruciferous vegetables, including broccoli and          cabbage, and chlorophyllin tablets. Chlorophyllin is a compound in some foods that          protects against genetic damage.        -  Urine sampling: Participants collect a urine sample each morning except Saturday and          Sunday.        -  Stool sampling: Participants collect two stool samples during the study, one during the          second week and another during the fourth week.        -  Blood draw: About 2-1/2 tablespoons of blood are drawn once a week for research          purposes. The blood is tested for the effects of eating foods in the different diets          used in the study.        -  Rectal biopsies: Four pinch biopsies, each about the size of a grain of rice, are taken          from the rectum once a week for research purposes. For this procedure, forceps are          inserted shallowly into the rectum to collect the tissue. The effects of the different          diets on the colon cells are measured.   "
191085|NCT00340366|"     This study will examine how the body metabolizes micronutrients, such vitamins, during     pregnancy and how genetic make-up influences their metabolism. Vitamin B12 and folate levels     in pregnancy have been linked to birth defects, such as neural tube defects, orofacial     clefts, and congenital heart disease. Other micronutrient levels may be related to other     birth defects or pregnancy complications. This study will characterize the patterns of     micronutrient status during pregnancy and compare it with genetic variants and biochemical     parameters. Information about the relationship between genes and vitamin metabolism may help     doctors advise women about their nutritional requirements during pregnancy to protect their     health and the health of their babies.      This study is a collaboration between NIH and Trinity College in Dublin, Ireland. Women of     Irish origin 18 years of age or older who are receiving prenatal care at the Coombe Women's     Hospital in Dublin may be enrolled. Fathers also may participate.      Upon entering the study, female participants complete a questionnaire relating to their food     and vitamin intake, alcohol consumption, smoking behavior, and use of medications, and     provide a blood sample. Additional blood samples are collected during routine clinic visits     at about 24 and 34 weeks of pregnancy, and again at delivery and from 6 weeks to 2 months     after the baby's birth. Permission will be requested to obtain a blood sample from the     umbilical cord at birth after it has been removed from the baby.      Fathers of the babies are also asked to answer a short questionnaire and to provide a DNA     sample for genetic studies. To collect the DNA, sterile cotton swabs are rubbed around the     inside of the mouth to obtain cheek cells from which the DNA is extracted.   "
191086|NCT00340379|"     The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of     psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy.   "
191087|NCT00340392|"     Background:        -  Cancer stem cells in breast cancer have been identified as a small population of tumor          cells whose self-renewal mechanism is highly deregulated. This deregulation seems to be          necessary for cancer to develop.        -  These cells can be identified by certain surface markers that overlap with markers          associated with normal embryonic stem cells.      Objective: To isolate tumor stem cells using the same methods generally used to isolate human     embryonic stem cells.      Eligibility:        -  Tissue samples will be obtained from the human cooperative network.        -  Samples will include normal tissues from individuals who have no opportunistic diseases          and from individuals with cancer.      Design: Breast cancer stem cells will be isolated, grown in the laboratory and characterized.   "
191088|NCT00340405|"     The overall goal of this project is to identify strategies to reduce lung cancer incidence     and mortality. Using a high-risk occupational cohort, our specific objectives are 1) to     establish a biologic specimen bank and data bank that can be used for the validation and     refinement of potential early markers of lung cancer, and 2) to establish a cohort for the     study of environmental (including dietary) and genetic risk factors for lung cancer.      Lung cancer is the leading cause of death from malignant neoplasms in the United States and     in many countries around the world. Potential strategies to reduce the incidence and     mortality of lung cancer include new methods of early detection and identification and     alteration of etiologic factors.      The Yunnan Tin Corporation (YTC), located in Yunnan Province in southern China, is a large,     nonferrous-metals industry, formed in 1883 and nationalized after the establishment of the     People's Republic in 1949. It is involved principally in the production of tin from the mines     around the city of Gejiu. The tin miners at YTC have extremely high rates of lung cancer.     Among those at high risk, defined as miners 40+ years old with 10+ years of underground     mining and/or smelting experience, more than one percent per year develop lung cancer. These     extraordinary lung cancer rates result from combined exposure to radon, arsenic, and tobacco     smoking in the form of cigarettes and/or bamboo water pipe.      The study population for the development of a biologic specimen bank for the study of early     markers of lung cancer is all YTC miners considered to be at high risk for lung cancer based     on their occupation exposure (40+ years old with 10+ years of underground or smelting     experience). Currently numbering over 7,000, this high-risk group has been the target for the     annual lung cancer screening program at the YTC for the past 20+ years. For each high-risk     miner, sputum samples are collected annually, read for cytologic interpretation, and stored     in Saccomanno's solution for future early marker research. Screening chest x-rays are also     obtained. Subjects are followed annually to determine if any have developed lung cancer.     Diagnostic workup of suspicious cases includes an additional sputum sample and histology     specimen(s), which are used for diagnostic purposes and also retained for future research.      Additional biologic specimens have also been obtained on screenees for etiologic research,     including a one-time collection of whole blood, urine, and toenail clippings. Finger stick     bloods and buccal smears for DNA will also be sought.   "
191089|NCT00340418|"     This study will explore the ways in which lung transplants are rejected. A series of     experiments will evaluate the differences in airway gene expression. Lung transplantation has     become an important option for patients with advanced lung disease. More than 10,000 patients     have received them to date, and about 1,200 transplant operations are performed worldwide     each year. Although short-term survival has continued to improve, the 5-year survival rate is     less than 50%. Most posttransplant deaths are directly or directly caused by chronic lung     rejection, a condition of scarring that worsens lung function. .      Patients ages 18 and older who have received lung transplants, who are undergoing     bronchoscopy as part of the usual care after transplant, and who are not pregnant may be     eligible for this study.      Bronchoscopy and other procedures performed during this study are done only by doctors with     special training. They will take a total of 30 to 60 minutes. During a bronchoscopy, patients     will lie on a flat bed. They will be awake and follow instructions. First they will breathe     Xylocaine (lidocaine), an anesthetic mist, for 8 to 10 minutes. That will lessen the     discomfort of a small flexible tube called a bronchoscope that will be guided through the     back of the patient's mouth or nose and into the breathing tubes. When the flexible tube is     placed, patients will not be able to speak. They will receive the medication Versed     (midazolam), to make them relaxed and not remember most of the procedure, and fentanyl, to     decrease the possibility of feeling pain. These medications will be given through a narrow     tube feeding into a small needle placed into a vein in the arm. The risks of the tube placed     in the vein include bleeding, swelling, redness, and pain. Side effects from the medications     may include stomach upset, heart palpitations (awareness of heartbeat), and changes in blood     pressure. Patients will be carefully monitored for heart rate, blood pressure, breathing, and     oxygen levels.      During the bronchoscopy, a procedure called bronchoalveolar lavage is done, in which a small     amount of germ-free salt water is injected into through the bronchoscope into the lung and     immediately suctioned back, thus washing the lining of the airways and checking for infection     and rejection of the transplanted lungs. About 1 or 2 tablespoons of fluid will be collected     for analysis. Also, an endobronchial brush biopsy may be performed. A small brush removes     some of the cells from the surface of the airway. These cells will be sent to a laboratory at     Duke University Health system to analyze the signals from the cells that may eventually led     to scarring and chronic rejection of the lungs. Then, an endobronchial forceps biopsy is     performed, in which one or two small pieces, each about the size of a grain of rice, of the     lining of the lung's large airways is removed. A small surgical tool like tweezers is passed     into the lung. Risks of biopsies may include bleeding, injury to the lung, or an air leak in     the lung.      This study will not have a direct benefit for participants. However, it is hoped that     information gathered will enhance researchers' understanding of how lung rejection occurs.   "
191090|NCT00340431|"     This study will evaluate the safety of two experimental malaria vaccines in healthy     volunteers and examine their immune response to them. Safety will be assessed by comparing     vaccine side effects in groups of volunteers who receive increasing doses of the same vaccine     (dose-escalating study). Immune response will be evaluated by comparing the levels of     antibody production with each dose. (Antibodies are infection-fighting proteins produced by     the immune system.) The two vaccines in this study contain different types of a malaria     protein called MSP1: one type is MSP142FVO and the other is MSP1423D7.      Malaria parasites are spread from person to person by mosquitoes. There are four types of     malaria parasites. The vaccine tested in this study is designed to work against Plasmodium     falciparum, the parasite responsible for most deaths in children due to malaria in     sub-Saharan Africa. The vaccine stimulates the body to produce antibodies that prevent P.     falciparum from entering the person's red blood cells.      Healthy normal volunteers between 18 and 50 years of age may be eligible for this 12-month     study, conducted at Quintiles Phase 1 Services in Lenexa, Kansas. Candidates are screened     with a medical history, physical examination, and blood and urine tests.      Participants receive three doses of the vaccine-on the first day of the study (day 0), at 1     month (day 28), and at 6 months (day 180) -through injection into an arm muscle. The first     group of subjects receives 5 micrograms of vaccine, the second group receives 20 micrograms,     and the third group receives 80 micrograms. All participants are observed in the clinic for     30 minutes after each immunization for immediate reactions to the vaccine and keep a record     of their temperature and of any reactions and side effects they experience for 6 days after     the vaccination. At various intervals throughout the study, participants undergo a brief     physical examination and blood tests. Women of childbearing potential have a urine pregnancy     test on the day of each injection.   "
191091|NCT00340444|"     This study will examine the existence of genetic regions that are believed to bring about a     risk for inflammatory bowel disease (IBD), with its subtypes of Crohn's disease and     ulcerative colitis. It will identify the locations of chromosomes responsible for hereditary     IBD through linkage analysis, a technique in genetic research in which the occurrence of a     disorder in a family is evaluated alongside a known genetic disorder. The project will also     do fine mapping of genes and examine possible genes associated with IBD.      IBD is a chronic and often disabling disorder of the gastrointestinal tract, affecting about     500,000 Americans. Both Crohn's disease and ulcerative colitis share many characteristics,     such as abdominal pain, bloody diarrhea, fever, fatigue, and malnutrition. But the main     factors that distinguish these subtypes depend on the location and depth of inflammation.     Tests and analyses can generally pinpoint some of the differences between the two, but     sometimes there are major overlaps in characteristics, and the diagnosis is known as     indeterminate IBD. The exact cause of IBD is not known, but genetic and environmental factors     are known to contribute to risk for the disease. The single most important environmental risk     factor has been smoking exposure at the time the diagnosis is made. Also, several genetic     risk factors are ethnicity, family history, and polymorphisms-abilities to take on different     forms-in the NOD2 gene.      Patients who have a diagnosis of IBD and their family members 5 years of age and older who     have or do not have that diagnosis may be eligible for this study.      Participants will be asked to complete a questionnaire on their health, ethnic background,     religion, habits, family medical history, and medications. Information will also be sought on     the diagnosis, course, complications, and treatment of IBD, as well as risk factors. In     addition, there will be collection of blood to be used for DNA preparation, storage of     lymphocytes, and information on immunology.   "
191092|NCT00340457|"     Incidence rates of renal cell cancer have increased rapidly in the U.S. and other countries.     In particular, rates among African Americans have risen more sharply than any other cancer     site. We propose to conduct a population-based case-control study of renal cell cancer in     areas of the U.S. with a high proportion of African American residents. We will include two     study centers and one data coordinating center and will recruit study participants over a     period of four years. We plan to conduct in-person interviews with 2,100 cases (1,400 whites     and 700 blacks) and 2,800 controls (1,400 each of whites and blacks) to elicit information on     demographic background and history of exposures. A 40 ml blood sample will be collected from     living cases and controls to measure certain environmental exposures and for genetic     analyses. Two buccal cell samples will be collected from living cases and controls for     genetic analyses. Tumor tissue blocks will be collected from as many cases as possible for     assays of tumor mutations. Diagnostic slides will be collected for standardized     reclassification of tumors into clear cell, papillary, and other histologic subtypes. Medical     records for all cases will be reviewed for health insurance coverage, concomitant conditions,     presenting symptoms, tumor stage, size and grade, and methods leading to diagnosis of renal     cell cancer.   "
191093|NCT00340470|"     Teens are at high risk for traffic violations and car crashes because of their young age,     lack of driving experience, and exposure to high-risk driving conditions. The Checkpoints     Program has used increased parental restrictions on teen driving through at least the first 4     months after their children obtain a driver's permit.      The purpose of this study is to evaluate the efficacy of the Checkpoints Program.      Approximately 400 teens in Michigan will participate in one of two study groups. One group     will take standard driver education classes; the other group will take driver education     classes that incorporate the Checkpoints Program. Teens and their parents will complete a     written survey after completing the classes and a telephone survey after teens obtain a     driver's permit. Teens will complete additional telephone surveys 1, 3, 6, and 12 months     after obtaining a driver's permit. Researchers will use this information to study how parents     manage teen driving practices, teen driving experiences (amount and conditions of), and     high-risk teen driving behaviors.   "
191094|NCT00340483|"     This study, sponsored jointly by the George Washington University School of Public Health and     the NICHD, will compare the effectiveness of two self-help quit-smoking programs for young     people.      Smokers between 18 and 22 years of age who are interested in quitting smoking may be eligible     for this 6-month study. Candidates must be enrolled in school at least part time.      Participants are randomly assigned to one of two treatment groups. Both groups receive a     brief counseling session and self-help guide, and one group also receives email counseling     related to quitting smoking. All participants have three interviews-one in person at the     beginning of the program, one over the phone after 2 months in the program, and one in person     after 6 months, at the end of the program. The surveys cover the participant's intentions and     behaviors related to smoking cessation and their opinions about the self-help materials. In     addition, participants may be asked to provide saliva samples at the beginning and end of the     program for verifying smoking status.   "
191201|NCT00349076|"     Standard treatment for locally advanced cancer of the rectum is preoperative     chemoradiotherapy with 5-Fluorouracil (5-FU) plus 4 cycles of postoperative chemotherapy with     5-FU. According to our previous study (CAO/ARO/AIO-94, published in the New England Journal     of Medicine 2004; 351:1731-40) this treatment results in only 6% of local failures, yet,     still 36% of all patients develop distant metastasis. Therefore, our new study     (CAO/ARO/AIO-04) incorporates new drugs, i.e. 5-FU + oxaliplatin, in an effort to improve the     control of distant metastases. It is our hypothesis that the rate of disease free survival     will improve by 5 to 8% after 3 years of follow-up.   "
191280|NCT00350129|"     The primary objective is to assess the effect of glucose on retinal vascular diameter in     otherwise healthy vasospastic subjects compared to non-vasospastic controls.      The secondary objective is to compare the effect of glucose also on choroidal blood flow in     otherwise healthy vasospastic subjects with non-vasospastic controls.   "
191095|NCT00340496|"     Adults treated with X-rays in childhood for benign conditions such as enlarged tonsils and     adenoids have an increased risk of developing nervous system tumors. The risk is highest for     schwannomas (RR of 33.1, 95% CI of 9.4-116.5), intermediate for meningiomas (RR of 9.5, 95%     CI of 3.5-25.7) and lowest for gliomas (RR of 2.6, 95% CI of 0.8-8.6).      Studies of sporadic tumors of these types have demonstrated the presence of somatic mutations     in the NF2 gene. Because these mutations are not usually seen in other types of tumors, they     are believed to be what caused the sporadic neural tumors to develop. Germline mutations in     the same gene are responsible for the autosomal dominant disorder known as neurofibromatosis     2 (NF2) which is characterized by the development of similar types of neural tumors.      The purpose of the proposed study is to determine if neural tumors that developed in people     who were treated with X-rays in childhood also have somatic NF2 mutations. This will be done     using DNA from paraffin-embedded neural tumors that developed in ~ 112 individuals treated     with X-rays in childhood for benign head and neck conditions. These individuals are from a     cohort of over 4,000 irradiated persons followed by Michael Reese Hospital in Chicago since     1974. If we find NF2 mutations in the radiation-related tumors, we will determine whether     they are somatic or germline by looking for NF2 mutations in DNA from buccal cells of the     patients with the studied tumors. We expect that most patients will have NF2 mutations only     in tumor DNA. However, there is a remote possibility that one or more patients may have a     germline NF2 mutation and thus an increased risk of developing neural tumors even in the     absence of X-ray treatment. We will then compare the types and frequencies of the somatic NF2     mutations with those found in sporadic neural tumors. If we do not find somatic NF2 mutations     in the radiation-related tumors, we will conclude that X-rays caused neural tumors to develop     through interactions with another gene or genes. Either result will contribute to our     knowledge of radiation tumorigenesis.      We will send letters describing this study to patients from the Michael Reese Hospital cohort     who have developed radiation-related neural tumors. Those who consent to take part in it will     be asked for permission to obtain paraffin blocks from any neural tumor that they have had     removed and to donate buccal cells for NF2 mutation studies. Finally, they will also be asked     to complete a questionnaire that will help us update their medical history and obtain a     medical history on close blood relatives.   "
191096|NCT00340509|"     Studies have shown that there is a significant association between serum bilirubin     concentrations and risk of coronary artery disease (CAD). So far, no linkage analysis in     humans between serum bilirubin and DNA markers has been reported. The purpose of this     protocol is to identify chromosome regions that contain quantitative trait loci (QTL)     involved in serum bilirubin metabolism and bilirubin concentration. In the Framingham Study,     a 10cM genome scan (about 400 markers) has been conducted in more than three hundred     families. Serum bilirubin was measured in the first and second exams of the Framingham     Offspring. These data provide us the opportunity to undertake linkage analyses to map QTL of     serum bilirubin.   "
191097|NCT00340522|"     This study will construct tissue microarrays (TMAs) pertaining to childhood cancer. TMA     technology is a recently developed one that allows for evaluating hundreds of tissue samples     simultaneously on the DNA, RNA, and protein levels. The goal is to identify a potential     molecular signature. Cancer drug discovery is currently focused on identifying drugs targeted     at the molecular level. Such drugs would be more selective and specific for proteins and     signaling pathways that are directly involved in the origin of tumors. However, the origin of     cancer among adults differs from that of cancer diagnosed in children. The overall approach     by the pharmaceutical industry in developing drugs is not likely to be aimed at low-incidence     cancers, such as childhood cancers. Thus, the researchers in this study propose to create a     childhood cancer TMA that include specimens from a wide range of solid tumors that present a     poor prognosis for patients. This TMA would in turn be used to identify antibodies and lead     to developing molecularly targeted drugs that would reach clinical trials in adults.      TMAs are created robotically. Small tissue cores are taken from paraffin-embedded tissue     blocks and are implanted into new paraffin blocks. The recipient blocks are then processed to     produce several hundred specimens that can be evaluated on a single glass slide. Specimens     representing 17 distinct kinds of pediatric solid tumors will be used in this study. Also     included will be samples of plexiform neurofibroma-that is, benign growths of nervous and     connective tissues.      Tissue specimens will come from patients who were age 25 or younger at the time of diagnosis     of their cancer or plexiform neurofibroma. No procedures will be performed for the sole     purpose of obtaining tissue for this study.      The TMA developed in this study will not be commercialized. The results for individuals whose     tumor specimens are used in the array will not be sent to patients or their treating     physicians.   "
191215|NCT00349271|"     The purpose of this study is to determine effect of cell therapy in patients with severe     dilated cardiomyopathy   "
191098|NCT00340535|"     This study will examine whether genetic differences among individuals affect blood levels of     certain chemicals called DBPs after showering. Chemicals such as chlorine and ozone are used     to kill germs in water. These chemicals may react with organic matter in the water and form     other chemicals called disinfection byproducts, or DBPs. Although people are usually exposed     to DBPs by drinking tap water, these chemicals may also penetrate the body during showering.     This study will see whether the levels of DBPs after showering vary among individuals     depending on differences in genes that code for enzymes called GSTT1, CYP2D6, and CYP2E1,     which break down DBPs. This study, sponsored by the Centers for Disease Control and     Prevention and the National Institutes of Health, is conducted at the University of     Pittsburgh's Center for Clinical Pharmacology.      Healthy adults between 18 and 45 years of age who do not smoke cigarettes and are not taking     any medicines may be eligible for this study. Candidates are screened with a medical history     and blood and urine tests. Participants are given a diary to record the foods they eat and     how much water they drink during the 2 days before their study appointment. The following     activities are scheduled on the appointment day:        -  Measurements of blood pressure, height, and weight, and pregnancy test for women        -  Questions about alcohol consumed and medications taken in the last 48 hours        -  Review of food and water diary        -  Interview for demographic information (name, address, date of birth, etc.) and other          information, such as sex, height, weight. Subjects are also asked about anything, such          as exercise, that might affect their breathing, since breathing problems are a rare side          effect of chlorzoxazone, a drug used in this study.        -  Urine sample collection        -  Blood draw and insertion of a small catheter (plastic tube) to allow for additional          blood draws during the test procedure without having repeated needle sticks        -  10-minute shower in a private bathroom        -  Blood sample collection 10 minutes after the shower and again at 30 minutes after the          shower        -  Dose of chlorzoxazone (a drug used to treat muscle pain)        -  Interview about subject's exposure to water        -  Light breakfast        -  Blood and urine collections 2 hours after the chlorzoxazone dose        -  Lunch        -  Observation for drug side effects for 2 hours, or longer if needed      Seven blood samples totaling 75 milliliters (about 5 tablespoonfuls) of blood are collected     during this study. The blood is tested for chemicals called trihalomethanes to see how they     are broken down. The urine samples are tested for chemicals called haloacetic acids, which     are found in tap water after it has been treated with chlorine.   "
191099|NCT00340548|"     Background:      Over 80% of the hemophiliac population who became infected with HIV prior to 1985 are also     co-infected with HCV. Thus, hemophiliacs represent an important population for studies of the     natural history of these chronic viral infections.      Moreover, the high rate of co-infection makes it an ideal group for assessing the interaction     between the viruses and the relationship between viral specific immune responses and clinical     progression.      Although the hemophiliac poulation is unique, co-infection by these chronic viral pathogens     is becoming increasingly common, particularly amongst intravenous drug users, who account for     approximately 25% of the HIV-1 epidemic in the United States.      Objectives:      The aim of this study is to determine if polymorphism in the promoter region of TH1 and Th2     cytokines are associated with (1) intracellular cytokines levels in CD4 + Tcells, (2) Human     Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) viral loads, and (3) clinical     progression of HIV1 to AIDS in hemophiliacs.      Eligibility:      The current proposal will investigate host genetic factors related to HIV-1 and HCV     immunopathogenesis by studying children and adolescents enrolled in the Hemophilia Growth and     Development Study (HGDS).      Design:      This study is in collaboration with the principle investigators of the Hemophilia Growth and     Development Study (HGDS) as part of a grant Pathogenesis of HIV and HCV in Hemophilia:     HGDS-3 with funding support by NIH/NICHD for the period 9/25/01 through 8/31/2005.      This multicenter, United States study represents a well-characterized, prospectively followed     cohort of HCV-infected hemophiliacs, of whom 207 are HIV-1 co-infected.      Enrollment of the hemophiliac cohort was completed between 3/89 and 6/90. The final     observation of the cohort (follow-up 16) was concluded during 7/98. No new samples or     clinical data will be collected on this population.      The LGD plays two roles in this project: (1) an administrative role overseeing the     withdrawal, handling, and transport of samples from the HGDS/LGD and central repositories at     the NCI-Frederick, and (2) a scientific role continuing investigations to determine the role     of host genetic factors in Th1 and Th2 immune response and regulation of HCV and HIV viral     replication..   "
191281|NCT00350142|"     This study will assess the efficacy of treating locally advanced pancreatic cancer using     Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine   "
191768|NCT00348946|"     The purpose of this study is to evaluate the effects of low-dose androgen on the motor and     cognitive development of boys with Klinefelter syndrome.   "
191100|NCT00340561|"     This study will evaluate the driving performance of new teenage drivers and determine to what     extent independent driving experience improves driving performance of young drivers. Motor     vehicle crash rates are highest among new teen drivers, especially during the first 6 months     and 1,000 miles of independent licensed driving. Crash rates decline with experience, and     this study will assess the effect of driving experience on performance.      Newly licensed teenagers ranging from 16 years, 3 months to 17 years of age and experienced     drivers 30 to 50 years of age may be eligible for this study. Candidates must be able to     legally drive in the commonwealth of Virginia and have at least 20/40 correctable vision.      Participants complete a questionnaire about their health and driving experience. They are     then tested on a driving test track. Teens are tested within 3 weeks of obtaining their     driver's license and before they have more than 100 miles of independent driving experience.     They are tested a second time 6 to 12 months later and after they have more than 1,000 miles     of driving experience. A group of experienced adult drivers are also tested to provide a     comparison.      The driving test is conducted on a smart road - a controlled, 2.2-mile two-lane research     track at the Virginia Tech Transportation Institute. It is designed for safety, with     restricted access, nothing for a vehicle to hit, carefully placed guardrails, and other     safety features. The research vehicle is equipped with airbags, anti-lock brakes, and other     safety equipment. It also has sensors and tiny video cameras to assess the behavior of the     vehicle and the driver; this equipment does not interfere with the operation of the vehicle.      An experimenter accompanies the driver and instructs him or her to perform routine driving     skills, such as stopping, changing lanes and maintaining speed, as well as to other tasks     such as inserting a CD into an entertainment console, having a conversation, and answering a     cellular telephone call. The driver has an opportunity to practice the tasks before being     tested.      The driver's speed is limited to 35 mph or less during the experiment and the driver is     required to wear seat belts and follow safe driving procedures. The experimenter is in the     front passenger seat can stop the vehicle using a separate brake pedal.   "
191101|NCT00340574|"     This study will evaluate the safety and efficacy of the experimental malaria vaccine     AMA1-C1/Alhydrogel® (Registered Trademark) and determine whether a new, additional component     of the vaccine may increase its effectiveness. Malaria is a debilitating and potentially     fatal blood disease transmitted by a parasite found in certain mosquitoes. The AMA1-C1     vaccine has been designed to create an immune response against the parasite and prevent the     disease. The purpose of the study is to determine whether the additional component-protein     pieces known as CpG- improves the immune response to the vaccine without causing problematic     side effects.      Volunteers must be healthy adults between 18 and 45 years old. Individuals who have had     malaria in the past or have recently traveled to areas where malaria is endemic will be     excluded from the study. Candidates will be screened with a physical examination, blood     tests, and medical history.      Participants will be involved in a three-stage study. In the first stage, a group of     participants will receive either a high dose of the vaccine alone or a low dose combined with     the CpG protein. In the second stage, a different group of participants will receive a high     dose of the vaccine alone or a high dose combined with CpG. In the third stage, a larger     group of participants will receive a high dose of the vaccine alone or a high dose combined     with CpG. The vaccine will be injected into the muscle of the upper arm, and all participants     will receive three doses of the vaccine with 28 days between doses to monitor possible     reactions and side effects. Participants will be monitored for 30 minutes after each     injection and will record any symptoms they experience over the six days after receiving     their dose. In addition, participants will be examined over the course of six months during     and after the trial with physical exams and blood and urine tests.   "
191102|NCT00340587|"     At fertilization, the binding of sperm to the zona pellucida induces the acrosome reaction     releasing lytic enzymes that facilitate the passage of the sperm through the zona. The sperm     then fuses with the egg's plasm membrane and enters the egg's cytoplasm. The zona pellucida,     an extracellular matrix composed of three glycoproteins (ZP1, ZP2, ZP3), mediates the     species-specific binding of sperm to egg. Although homologous proteins are present in mouse     and humans, human sperm will not bind to the mouse zona pellucida and when the zona pellucida     is experimentally removed, human sperm will not bind or fuse to the mouse egg's plasm     membrane. We have created transgenic mouse lines that express one or more human zona     proteins. We wish to determine if human sperm will bind to these chimeric zonae and if this     binding will induce the human sperm acrosome reaction. Sperm and devitalized eggs will be     collected by collaborating institution(s) under protocols and consent forms approved by that     institution's IRB. Only procedures already being performed on subjects for diagnostic or     treatment purposes will be used.   "
191115|NCT00340756|"     The purpose of this study is to evaluate the reproducibility of measurements of sex hormone     levels in serum samples. Researchers will collect blood from 60 healthy adults, including 20     men, 20 premenopausal women, and 20 postmenopausal women. Blood samples will be collected     after study participants have fasted overnight.   "
191103|NCT00340600|"     Diethylstilbestrol (DES), a drug first synthesized in 1938, was administered to several     million pregnant women in the U.S. and Europe for the prevention of spontaneous abortion and     premature delivery. In 1971, Herbst reported a strong association between DES use in     pregnancy and the occurrence of vaginal clear cell adenocarcinoma (CCA) in exposed female     offspring. Animal models have demonstrated a range of DES effects on offspring exposed in     utero, including reproductive dysfunction, immune system changes, behavioral and sexual     abnormalities, and increases in various reproductive cancers in males and females. In the     mid-1970's, several separate cohorts of DES-exposed daughters and unexposed comparison groups     were followed for the occurrence of cancer, precursor lesions, and reproductive effects, but     systematic follow-up of these cohorts had ceased by 1990. In 1992, Congress passed a bill     (H;.R. 4178) mandating the continued follow-up of DES-exposed cohorts. The National Cancer     Institute, in collaboration with five field centers, reassembled previously studied cohorts     of DES-exposed and unexposed mothers, daughters and sons, and identified subjects with     documented exposure status who had not been studied previously, through familial links within     the cohorts. Standardized baseline questionnaires were mailed to cohort members to ascertain     the risk of cancer and other disorders. Pathology reports were collected for reported cancers     and preneoplastic conditions. Two separate rounds of follow up have been conducted and a     third is almost complete. Patients from the Registry for Research on Hormonal Transplacental     Carcinogenesis (the Registry) will be added to the follow-up effort in the third phase. The     purpose of this study is to continue the follow-up, by means of mail questionnaires and     medical record collection, which was begun during the first phase of the study. Concern has     arisen that DES-exposed daughters may be at higher risk of breast cancer. Exposure to high     levels of endogenous estrogen in utero has been hypothesized to increase the risk of breast     cancer and DES is a potent estrogen. Cancer risk in the sons will also continue to be     assessed, especially for increased risks of prostate cancer. Since the offspring who were     exposed to DES in utero are currently reaching their late forties, when cancer rates begin to     rise, it is important to continue the follow-up of these cohorts to determine if there are     long-term increases in cancer risk.   "
191104|NCT00340613|"     We hypothesize that checking blood sugar and taking long and short acting insulin before     lunch at school may improve overall blood sugar control, grades, and decreases school     absences in children and teens with poorly controlled T1DM.   "
191105|NCT00340626|"     In a collaborative effort with the IBN AL-NAFEES Hospital (Damascus, Syrian Arab Republic),     individuals from multiplex families determined to have hereditary oral clefts will be     studied. The purpose of this study is to identify the gene(s) involved in heritable oral     clefts by linkage analysis and gene mapping strategies. Characterization of genes involved in     inherited oral clefts could provide important insight into the inheritance and pathogenesis     of this disease.   "
191202|NCT00349089|"     The purpose of this randomized phase II trial is to determine the clinical feasibility - in     terms of patients without dose limiting toxicities or premature treatment withdrawal or death     - of the combination of Cisplatin and Pemetrexed and of the combination of Cisplatin and     Vinorelbine. The combination of Cisplatin / Pemetrexed is assumed to be distinctly less toxic     than Vinorelbine / Cisplatin.   "
191282|NCT00350155|"     This study is designed to investigate the potential differences in GI safety and tolerability     in the small bowel between lumiracoxib, conventional non-selective NSAID (naproxen) with a     proton pump inhibitor (omeprazole), or placebo.   "
191106|NCT00340639|"     This 1-year study will explore the influences of family and peers on how diabetic adolescents     manage their disease, focusing on adolescent developmental transitions. The management of     diabetes is a complex process involving daily self-care activities, problem-solving, and     decision-making. It is particularly challenging during adolescence when youth are     experiencing physiological, social and psychological changes, and coming under increasing     peer influence and decreasing parental supervision. Although it is expected that the     responsibility for diabetes management will gradually shift from the parent to the child     during adolescence, research indicates that many children may be given responsibility for     managing their illness too early, without adequate parental monitoring. Specifically, this     study will examine the following issues:        -  The relationship of peers, parents and school support to successful diabetes management;        -  The influence of the adolescent's self-image and personal goals on diabetes management;        -  The influence of the adolescent's and parents' attitudes, capability and environment on          the balance of responsibility for diabetes management.      Children between 10 and 16 years of age receiving treatment for diabetes type 1 at Georgetown     University Medical Center's pediatric diabetes clinic may be eligible for this study. The     children must have been diagnosed with diabetes at least 1 year before entering the study and     must require insulin treatment. One parent of each child will also participate in the study.      Children and their parents will complete the following procedures:      Home Interviews: Parents and children will complete two at-home face-to-face interviews 6     months apart. At each interview, children will answer questions about their responsibility     for and adherence to their diabetes management, treatment outcome expectations, optimism,     self-esteem, self-consciousness, personal goals, social support, perceived barriers to     diabetes management, family routine and family conflict, their parents' involvement in their     diabetes management, and parenting style. Parents will evaluate their child's ability to     manage his or her diabetes, level of maturity, self-esteem, and transition of responsibility;     their family routine and family conflict, parent-child communication, their parenting goals,     and their involvement in and responsibility for their child's diabetes management. Three days     after the 6-month interview, a randomly selected group of parents and children will complete     a brief, additional telephone interview covering some of the same issues.      Telephone Interview: At 12 months, parents and children will complete a telephone interview     that will include questions about adherence to diabetes management and the responsibility of     parents and children for diabetes management.   "
191107|NCT00340652|"     This study, conducted at the Children's Hospital of Boston and the Brigham and Women's     Hospital in Boston, will examine the natural history of infant development in the first year     of life and how different types of infant feeding may affect that development. During     pregnancy, babies are exposed to the female hormone estrogen from their mothers. Estrogen     affects development of breasts and milk production, as well as the development of the uterus,     ovaries and possibly other hormonally responsive organs in both males and females. Between 6     and 12 months of age, the effects are reduced. Breast milk and some infant formulas may     contain compounds that can act like female hormones in the body and may prolong the estrogen     effects. This study will examine the natural history of estrogen activity in infants on     different feeding regimens, breast milk, cow's milk, and soy milk and will serve as     preparation for a larger study of the effects of soy formula on estrogen activity in infants.      Full-term female babies (37 to 41 weeks gestational age at birth) from 0 to 12 months of age     and male babies from birth to 6 months of age who weigh from 2501 to 4499 grams (about 5.5 to     10 pounds) at birth and who have no chromosomal abnormalities, major malformations, or     endocrine problems may be eligible for this study. Males must have palpable testes. Babies     being fed a diet of breast milk, soy milk, or cow's milk will be included. Study procedures     include the following:        -  History of the baby's dietary intake since birth, provided by the parent;        -  Ultrasound measurement of the uterus, ovaries, and breasts in female babies; the testes,          prostate, and breasts in males; and the thymus, thyroid, and kidneys in all babies;        -  Measurements of all babies' weight, length, and head circumference.   "
191116|NCT00340769|"     The CCCH tandem zinc finger proteins are members of a small family of proteins that regulate     the stability of certain types of mRNA containing so-called class II AU-rich elements in     their 3'-untranslated regions. The best studied member of this protein family,     tristetraprolin (TTP), exerts this destabilizing effect on at least two mRNAs coding for     physiologically and medically important cytokines, tumor necrosis factor alpha and     granulocyte macrophage colony stimulating factor. The physiological functions of the other     two members of this protein family in mammals, 11B and 11D, are not known, but in     experimental transfection studies they too can destabilize mRNAs containing this type of     AU-rich element.      As part of the Environmental Genome Project, we resequenced the protein coding portions of     the human genes encoding these three proteins, and uncovered a dinucleotide splice site     mutation in the 11B gene in one of 144 alleles sequenced. We showed that this mutation     created a novel restriction fragment length polymorphism, and that this mutation resulted in     the failure of splicing and expression of the mRNA encoded by the mutant allele. Based on our     previous data with mice completely deficient in TTP, we anticipate that complete deficiency     of this protein, and possibly its partial deficiency, would result in human disease.      The mutant allele was from an anonymous adult Aka Pygmy women from the Central African     Republic. We propose to genotype up to 1000 members of this ethnic group after obtaining     buccal cell DNA from them. This will give us an approximate idea of the prevalence of this     mutation in this population. If the mutation is found in a significant number of living     individuals in this initial screen, then we will propose a later study of the individuals who     have this genotype and their families. This second study, which will be reviewed separately,     will attempt to correlate this genotype with a human trait or phenotype and possible y     treatable human disease.   "
191445|NCT00344682|"     This study is evaluating the efficacy and safety of the drug memantine (trade name NAMENDA)     as an augmentation agent for the treatment of depression in people who are not fully     responding to antidepressant medications.   "
191108|NCT00340665|"     This study, conducted at the University of Pennsylvania s Newborn Nursery, the Children s     Hospital of Philadelphia, and the Exton Specialty Care Center, will examine how different     infant diets may affect estrogen activity in babies. During pregnancy, babies are exposed to     the female hormone estrogen from their mother. Estrogen plays a key role in the development     of breasts and milk production, as well as the development of the uterus. The effects of     these hormones can be seen when babies are examined. Between 6 and 12 months of age, the     effects are reduced. Breast milk and some infant formulas may contain compounds that can act     like female hormones in the body and may prolong the estrogen effects.      This study has two parts. Part 1 studies the physical development of babies fed different     ways. Part 2 studies how hormone levels in babies differ depending on what they are being     fed. Babies may participate in one or both parts. Part 1 includes babies 0 to 6 months of     age; part 2 includes babies 0 to 12 months of age. In each part of the study, parents may     choose to have their babies evaluated from one to four times.      Full-term infants (age 37 to 41 weeks gestational age) from birth to 12 months of age who     weigh from 2501 to 4499 grams (about 5.5 to 10 pounds) at birth and who have no chromosomal     abnormalities, major malformations, or endocrine problems may be eligible for this study.     Male infants must have palpable testes. Infants being fed a diet of breast milk, soy milk, or     cow s milk will be included. Study procedures include the following:      Part 1        -  Feeding history: the parent provides information about the baby s dietary intake since          birth.        -  Length, weight, and head circumference: the baby s measurements are taken.        -  Physical examination: the baby s physical maturity is assessed by examination of the          skin, breasts, and external sex organs.        -  Breast secretions: the baby s breast buds are gently pressed during the physical          examination to look for a milky-white substance that some babies produce during the          first year of life. If the substance appears, a specimen will be collected.        -  Vaginal cells: for baby girls, the opening of the vaginal area is gently swabbed with a          sterile Q-tip to assess the maturity of the vaginal lining.      Part 2        -  Feeding history and length, weight and head circumference measurements as described          above.        -  Urine: a urine sample is collected in a cotton diaper or a urine collection bag.        -  aliva: a saliva sample is collected by gently swabbing the inside of the baby s mouth 1          hour after a morning feeding to remove any left over milk.        -  Hair: a lock of hair, 1/2-inch wide and 1 to 2 inches long is taken from 12-month old          babies.        -  Blood: some infants have a small blood sample collected by a heel-stick.      This study will serve as a basis for a later study about how infant formulas affect infant     growth.   "
191210|NCT00349206|"     This phase I trial is studying the side effects and best dose of temsirolimus when given     together with sorafenib and to see how well they work in treating patients with metastatic,     recurrent, or unresectable melanoma. Sorafenib and temsirolimus may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the     growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with     temosirolimus may kill more tumor cells.   "
191109|NCT00340678|"     This investigation is a randomized, double-blinded, placebo-controlled clinical trial in     adult diabetic Pima Indians with normal urinary albumin excretion (albumin-to-creatinine     ration less than 30 mg/g) or microalbuminuria (albumin-to-creatinine ration = 30-299 mg/g) to     test the hypothesis that blockade of the renin-angiotensin system with the angiotensin     receptor blocker (ARB) losartan can prevent or further attenuate the development and     progression of early diabetic nephropathy in subjects with type 2 diabetes mellitus who are     receiving standard diabetes care.      One hundred seventy subjects were recruited for the study, all of whom had type 2 diabetes     for at least 5 years, serum creatinine concentrations less than 1.4 mg/dl, and no evidence of     non-diabetic renal diseases. Ninety-two of the subjects had normal urinary albumin excretion     at baseline and other 78 had microalbuminuria. Subjects in each albumin excretion group were     randomized to treatment with either the angiotensin II receptor antagonist, losartan, or     placebo. Measurements of glomerular filtration rate (GFR), renal plasma flow (RPF) and     fractional clearances of albumin and IgG will be made initially, at one month, and at     12-month intervals from baseline thereafter. A kidney biopsy was performed after six years in     111 subjects. Morphometric analysis of renal biopsies was used to determine differences in     glomerular structure between treatment groups.   "
191110|NCT00340691|"     This study will examine: 1) the safety and effectiveness of the drug doxycycline in reducing     the number of Mansonella perstans (Mp) worms in the blood of infected patients, and 2) the     effects of doxycycline followed by albendazole and ivermectin treatment for lymphatic     filariasis, caused by the parasitic worm Wuchereria bancofti (Wb).      Both Mp and Wb very small filarial worms that are spread by mosquitoes. Some people are     infected with both Mp and Wb. Although most people do not become ill from infection with     these parasites, some develop symptoms. Wb can cause swellings in the arms, legs, breast, and     scrotum, and can progress to permanent swelling of the legs or arms called elephantiasis. Mp     can cause itching, swelling, fever, headache, or other symptoms. Ivermectin and albendazole     are medicines used to treat lymphatic filariasis. They eliminate the Wb parasite from the     blood but do not affect Mp. Doxycycline is used to treat many kinds of infections and has     also recently been shown to reduce the number of filarial worms in several types of filarial     infections. The drug may be useful in Mp infections as well.      Residents of Sabougou and nearby villages in Mali who are infected with the Mp parasite, are     between 14 and 65 years of age, are in good health, are not pregnant or breastfeeding, and     weigh at least 40 kg (88 lb) may be eligible for this study. They may or may not also be     infected with Wb. Candidates are screened with a brief medical history and physical     examination and blood tests to look for infection with Mp and Wb.      Participants undergo a complete physical examination and medical history. Blood is drawn for     routine blood tests. Participants are then randomly assigned to one of four treatment groups,     as follows: 1) doxycycline for 6 weeks; 2) doxycycline for 6 weeks followed by a single dose     of albendazole and ivermectin given 6 months after the beginning of doxycycline treatment; 3)     a single dose of albendazole and ivermectin given 6 months after the beginning of doxycycline     treatment; or 4) no treatment. Only patients infected with Wb receive albendazole and     ivermectin treatment.      All participants, whether or not they receive doxycycline, come to the clinic every day for 6     weeks. Every 2 weeks during this time, they have a blood test and, in women of childbearing     age, a urine pregnancy test. After 6 months, they have a medical history, physical     examination, and blood tests. Subjects in the albendazole/ivermectin treatment group are     given the pills to take at that time. One year and three years after beginning the study,     participants return to the clinic for a final history, physical examination, and blood tests.      At the end of the first year of the study, all participants who tested positive for lymphatic     filariasis but did not receive ivermectin and albendazole will be offered treatment with     these medicines Ivermectin and albendazole will also be distributed by the Mali government to     everyone in the villages as part of a program to eliminate lymphatic filariasis in the     country.   "
191111|NCT00340704|"     Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and     evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in     children with a neuropathic bladder, over the course of 12 months of active treatment.   "
191112|NCT00340717|"     This study will determine whether certain gene alterations can serve as markers for early     detection of prostate cancer. Prostate cancer is often diagnosed by detecting high levels of     a protein called prostate-specific antigen (PSA) in the blood. Other conditions can also     cause elevated PSA levels, however, so that additional tests are needed to distinguish     between benign and cancerous prostate conditions.      Patients between 40 and 75 years of age who are referred to Howard University Hospital in     Washington, D.C., or Madigan Army Medical Center in Tacoma, Washington, for ultrasound and     needle biopsy to diagnose prostate cancer may be eligible for this study.      Participants will undergo the following procedures at the time of the biopsy visit:        -  Blood collection: Patients have 10 milliliters (2 teaspoons) of blood drawn.        -  Prostate massage: Patients have a rectal examination and prostate massage. For the          latter procedure, the physician lightly massages the prostate gland for about 15          seconds. After the massage, the patient provides a urine specimen.        -  Biopsy: A small sample of tumor tissue is removed surgically for examination under the          microscope.      Patients whose initial biopsy does not show cancer cells, but who are advised to have a     repeat biopsy in the future will give a blood, urine, and biopsy specimen at the time of the     next biopsy.      Patients who are diagnosed with prostate cancer and undergo surgery to remove the tumor will     have a small sample of tumor tissue set aside for this study to look for substances that may     help predict prostate cancer.   "
191216|NCT00349284|"     Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and     elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid     triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in     this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and     ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile     of this patient population.   "
191118|NCT00340795|"     This study will evaluate the impact of a Media-Smart Youth (MSY) curriculum on adolescent     knowledge and behavioral intent regarding media messages, nutrition, and physical activity.     The study is part of the U.S. Government's efforts to fight obesity and increase physical     activity among American youth. The MSY program seeks to empower adolescents to make healthful     choices about nutrition and physical activity by helping them understand how media can     influence their lives. This is important because it is estimated that young people view as     many as 40,000 commercial messages a year on television alone, many of which promote     unhealthy snack foods and beverages.      Youth between 11 and 13 years of age who are participating in selected after-school programs     in the Washington, D.C., metropolitan area may be eligible for this study.      Participants are randomly assigned to either receive the MSY curriculum or serve as controls.     Youth in the MSY group participate in a workshop consisting of 10 lessons and a creative     project to create a media message for their peers on the topic of nutrition and physical     activity. During the sessions, the young people receive information on nutrition and physical     activity and learn about media production and how to critically examine the media. Youth in     the control group participate in after-school programs unrelated to MSY. All participants     fill out questionnaires measuring their knowledge, skills, and behavioral intent related to     media analysis, nutrition and physical activity both at the start of the study and at its     completion.   "
191879|NCT00358111|"     This is a post-approval, multi-center, single-arm study (n=950) designed to address the     relationship of the LUMA device performance to patient age, patient human papillomavirus     (HPV) status and colposcopist experience.   "
191119|NCT00340808|"     This study, sponsored by NCI and the Gynecologic Oncology Group (GOG), will collect tissue     samples from women with cancer of the endometrium (lining of the uterus). Researchers will     use the samples to learn more about endometrial cancer and develop new treatments and methods     of prevention.      Women with endometrial cancer who are suitable candidates for surgery and who have not had     prior retroperitoneal surgery or pelvic or abdominal radiation therapy may be eligible for     this study. Candidates will be screened with a medical history and physical examination,     blood tests, and endometrial biopsy (surgical removal of a small tissue sample) or dilation     and curettage (D & C).      Participants will undergo hysterectomy (surgery to remove the uterus) along with removal of     both fallopian tubes and ovaries. This is the standard surgical treatment for endometrial     cancer. Lymph nodes in the pelvis near the main blood vessel in the abdomen are also removed     to determine if the disease has spread to these nodes. If cancer is found involving other     sites, the cancer in those areas may also be removed; examination of the tissues will     determine if further therapy beyond surgery is needed.      Before surgery, patients will complete a 20-minute questionnaire that includes questions     about their background, reproductive history, menstruation and menopause, certain surgeries,     birth control pills and hormone replacement therapy, other drugs and medicines, weight and     height, smoking, medical history, and family history of cancer.      Some of the tissue removed during surgery, plus a urine sample collected from a catheter bag     during surgery, and blood drawn before surgery and at follow-up visits 6 weeks and 3 years     after surgery, will be sent to the GOG Tissue Bank in Columbus, Ohio. This bank stores,     processes, and distributes biological specimens from patients that agree to participate in     studies conducted by the GOG.      Patients will have follow-up visits 6 weeks after surgery, then every 6 months for the next 2     years, followed annually for the next 7 years, for a total 10-year follow-up. The visits will     include an examination and questions about health status and treatments received between     visits. Patients whose cancer returns or worsens will undergo another tumor biopsy, if     possible, at that time.   "
191120|NCT00340821|"     Doctors of the University of West Indies, the Caribbean Epidemiology Center (CAREC) and the     National Cancer Institute have been studying the epidemiology of HTLV-I and its role in the     etiology and pathogenesis of adult T-cell leukemia/lymphoma (ALT), and aggressive T-cell     lymphoma. The purpose of the current study is to evaluate familial and genetic aspects of ATL     and its relationship to two other HTLV-I related conditions, HTLV-I associated myelopathy     also known as tropical spastic paraparesis (HAM/TSP), and infective dermatitis. Enrollment of     infective dermatitis cases was recently added and the disease entity is thought to be a     harbinger for later development of either ATL or HAM/TSP. The purpose of this study is to     interview patients with these conditions and perform laboratory studies (specifically, HLA     and other viral or genetic studies) to better understand these diseases and their     relationship to the HTLV-1 virus and the family history and genetic factors that may be     involved as well.   "
191121|NCT00340834|"     This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod     versus interferon β-1a to reduce the frequency of relapses in patients with     relapsing-remitting multiple sclerosis.   "
191122|NCT00340847|"     The proposed research intends to construct a set of tissue microarrays containing different     types of normal and lung cancer tissues for the study of genes associated with lung cancer.     Thus far we have generated a lung cancer tissue arrayusing paraffin embedded archival tissues     from 300 lung turmors tissues and 100 adjacent normal tissues. Four- micrometer thickness     sections have been cut from the tissue array and were used to survey gene expression status     in arrayed tumors using immunohistochemistry methody. We are currently performing IHC studies     ot 1) determine protein expression and its correlation with gene expression patterms ovserved     using cDNA arrays. 2) Analyze protein expression in the chromosome remodeling pathyway in     non-small cell lung cancer. And 3) determine the association of gene expression with lung     tumor stage and clinical outcome. The current protocol is needed to complete the above     studies and for the production of neuroendocrine tumors.   "
191123|NCT00340860|"     The Norway Mother and Child study is a collaborative venture among health researchers in     Norway funded by the Norwegian government. The study is being coordinated by the National     Institute of Public Health (aka Folkehelsa) in Oslo and the Medical Birth Registry (MBR) in     Bergen. NIEHS has the unique opportunity to participate through the collection of additional     tubes of blood during the blood sample collection; these two tubes of blood and a urine     sample will allow NIEHS and collaborators to explore environmental determinants for disease     among women and their children. These additional samples will remain in the Biobank in Oslo,     Norway, with other samples from cohort members and will be used under collaboration with     Norwegian investigators.      To achieve better health for mothers and children in the future, the Norway Mother and Child     study is designed to test specific hypotheses about the causes of a number of serious     diseases by recruiting 110,000 pregnant women to a cohort study. As part of the primary aim     of the study, women will be asked to provide a blood sample at 17 weeks gestation, at birth,     and 4 days after birth. The NIEHS samples will be collected at the blood draw at 17 weeks     gestation. Likely causal factors will be linked to information obtained from questionnaires,     blood samples, and medical registers.      The Norway Mother and Child study has multiple endpoints. Primarily those associated with     adverse pregnancy outcomes will be studied, but also diseases affecting mother, father or     child. Endpoints will be taken from questionnaires and medical registers. The study will be     carried out nationally and any research groups with relevant questions will be able to     participate. The Norway Mother and Child study has been approved by the Norwegian Parliament     as well as their Data Inspectorate to ensure that the study and all protocols conform to     Norwegian ethical standards as well as appropriate research ethical criteria. Further, the     project has been evaluated by the Regional Ethics Committee for Medical Research which has     approved all modifications to the project.      Other researchers, nationally and internationally, will have access to the cohort on request     and following approval from the project's executive group. NIEHS has the opportunity to add     additional biological specimens for blood and urine to the base cohort. Two additional tubes     of blood (total volume 9 ml) and a urine sample will be collected as part of the routine     prenatal ultrasound visit and blood sample collection included in the overall study protocol.     As part of a reliability sub-study, blood and urine samples will also be collected an     additional two times, at weeks 23 and 29 of gestation. These samples are designed to allow     investigators to explore environmental contributors to the health of women and their     children. Low level exposure to environmental contaminants occurs in all industrialized     countries, though the level of exposure may differ as the result of diet, cooking practices     and pollution sources. However, the ability to explore the role of environmental exposure on     health is often more limited by good population-based information on health and disease then     by exposure level. Thus, by creating a biological specimen repository in a country with     excellent disease registries, it will allow NIEHS to explore risk factors for disease     relevant to US populations. All samples will be stored in Norway and will be used in     collaboration with Norwegian and other investigators. NIEHS investigators will not have     access to identifying information. NIEHS samples will not be used for genetic analyses.   "
191124|NCT00340873|"     In 1976 an accidental explosion in a chemical plant 16 miles north of Milan resulted in     contamination of the local population with 2, 3, 7, 8-terachlorodibenzo-para-dioxin (TCDD).     There is evidence that TCDD and related phenoxy herbicides act as teratogens, tumor     promoters, and carcinogens in experimental animals. In human, TCDD causes chloracne in those     exposed. Associations with various cancers have been reported, but the precise role in human     toxicity, immune and reproductive dysfunction, and cancer is controversial.      The Seveso accident provides a unique opportunity for an epidemiological investigation in     that the exposures are the highest recorded in humans, the exposure involves TCDD without     other contaminants, and a cohort in the involved and surrounding area has been enumerated.      There is inter-individual variation in the action of genes involved in TCDD effect in human     cells. The quality of human AH receptor, and the CYP1A1 and arnt genotypes are examples of     susceptibility markers that may identify subjects at high risk for TCDD-related disease. A     hypothesis that could explain the inconsistent association of TCDD exposure with cancer is     that genetic susceptibility may influence which individuals are adversely affected by TCDD     exposure.      The study is proceeding in three phases. The first is a pilot/validation study that is     complete (field activities) and involved 126 subjects. The second is a case-control study of     about 100 individuals with chloracne and 100 controls. The field components of phase one and     two are complete, and analyses of results are underway. The third and final phase is a     planned case-control study of TCDD-related cancers that will include approximately 125 cases     and 125 controls.      The study includes a questionnaire/interview and a biospecimen collection; 73 ml of blood are     obtained from each participant.   "
191217|NCT00349297|"     Acute dacryocystitis in adults can be a very painful disease and may not respond well to     medical therapy.      The purpose of this prospective non-randomised study is to determine the microorganisms     causing acute dacryocystitis and the antibiotic sensitivities of these organisms.      The study also aims to correlate the microbiological findings to the severity of clinical     manifestations and evaluate the effectiveness of our current practice of aspiration and     empiric systemic antibiotic therapy in treating patients with acute dacryocystitis and hence     review whether there is a need to alter current management strategy.   "
191132|NCT00340990|"     This study, conducted at the University of Mali in the capital city of Bamako, will     investigate how the body reacts to infection with Mycobacterium tuberculosis (MTB), the     organism that causes tuberculosis. Tuberculosis is a major global health problem whose     solution requires development of an effective vaccine. However, incomplete understanding of     how immunity to MTB is acquired and measured limits vaccine development. This study will     focus on certain immune system cells - CD4+ T cells - that appear to be very important in     fighting tuberculosis.      Individuals 16 years of age and older who have or have not been exposed to either     tuberculosis or HIV, or both, may be eligible for this study. Candidates will be screened     with a medical history, physical examination, blood tests, review of medical records and     laboratory tests, and, if medically indicated, a chest x-ray. Individuals whose medical     records indicate a past history of tuberculosis or a positive test for exposure to     tuberculosis will have a tuberculin skin test. For this test, a few drops of fluid are placed     under the skin to see if the immune system reacts to the substance, indicating previous     exposure to MTB.      Participants will come to the University of Mali 10 times over a 1-year period - 7 times     within the first 3 months of the study and then once every 3 months until 1 year after     enrollment. At each study visit, they will be asked about their medical history and will     donate 75 milliliters (about 1/3 cup) of blood, totaling 830 mL over the entire year. More     blood may be requested if the participant's immune system reacts strongly to MTB in     laboratory tests. No more than 450 mL (2 cups) of blood would be collected every 6 weeks;     this amount is the Red Cross limit for regular blood donations every 6 weeks.      The blood samples will be used for tests that measure the level of immunity to tuberculosis.     Genetic tests may be performed on blood cells to help interpret special tests of immunity.     Because HIV-infected people are included in the study, the findings may also provide     information on how HIV renders vulnerability to opportunistic infections, including     tuberculosis.   "
191125|NCT00340886|"     The Environmental Genome Project (EGP) has completely or partially resequenced the protein     coding and regulatory regions of 53 environmentally sensitive genes from 72 anonymous     individuals of varying ethnic backgrounds to date. Some of the same genes have been     resequenced in an additional set of 20 samples, and, in a subset of these, the introns and     promoter regions have been sequenced as well. Within this population, 523 allelic variants     (genetic polymorphisms), mostly single nucleotide polymorphisms (SNPs), have been found to     date. If the polymorphism alters the behavior or expression of the encoded protein, it might     be of clinical significance.      The Office of Clinical Research is planning to establish a large resource bank of frozen DNA     samples (20,000) and make it available to NIEHS intramural investigators involved in the EGP     to screen for the presence of these SNPs and other mutations by standard genotyping methods.     To investigate the feasibility of such a large collection of samples, we plan to first     conduct a pilot study to estimate the accrual rate and uncover potential problems that may be     encountered in the larger effort. This IRB proposal is for the pilot study in which we will     collect whole blood samples (EDTA-anticoagulated) from 481 patients at UNC Medical Center.     Once the pilot study is complete, we will decide whether to proceed with the larger, 20,000     sample collection and if so, develop and submit for review a new IRB protocol for its     implementation taking date from the pilot study into account.      For both the pilot study and larger, 20,000 sample collection, only blood left over from     patients already having their blood drawn for hematology (complete blood count or CBC) assays     as part of their routine clinical management will be used, thus eliminating the need to     collect extra blood. Once the samples have been obtained from the clinical hematology     laboratory and processed, they will be identifiable only with a unique identification number     and sent to an NIEHS contractor (BioServe Biotechnlolgies, Laurel, MD) for DNA isolation.      During recruitment, interviewers will explain the study to potential participants, obtain     their signatures on the informed consent documents, and answer any questions they have     concerning this study. At this time, potential participants will be informed that, depending     on the results of the genetic analyses of their blood samples, they may be recontacted at a     later date and asked to participate in follow-up genotype/phenotype studies. These follow-up     studies will be separate from this protocol and the subjects of future IRB proposals. The     ultimate objective of these sample collections, combined with the follow-up     genotype/phenotype studies, is to identify groups of individuals with genetic polymorphisms     in environmentally sensitive genes, and to correlate their genotype with their clinical     phenotype, a process known as ascertainment by genotype.   "
191127|NCT00340912|"     Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial     growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their     donor but can be used for experiments where study conditions are much more precisely     controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima     Indians for two purposes. Firstly, to look for an in vitro system to measure insulin     resistance, the underlying abnormality in Pima diabetics. Secondly, to look for biochemical     markers of diabetes or obesity in Pimas employing two dimensional electrophoresis techniques.   "
191128|NCT00340938|"     This study will test the effectiveness of a practical, low-cost, problem-solving method     called WE CAN that can be taught to families at diabetes clinics. The goal is to see if this     teaching and support can help with controlling the level of blood sugar in children with type     1 diabetes as they approach adolescence. Attention would go to young people's completion of     tasks necessary to manage diabetes, quality of life, and psychological adjustments, plus the     role of the family in these situations. Type 1 diabetes mellitus, accounting for less than     10% of the disease cases, is marked by the inability of the pancreas to secrete insulin.     People who have it must consistently manage their disease. Successful disease management for     children depends on the family's adaptation to treatment demands. Yet maintaining acceptable     blood sugar control becomes more difficult for adolescents, owing to changes in the body     during that period of life. Also, early adolescence is a vital time in people's development     of health outcomes. The title WE CAN is a way to remember the steps of the problem-solving     method:        -  Work together to set goals        -  Explore barriers and solutions        -  Choose the best solutions        -  Act on your plan        -  Note the results      Children who have reached age 9 but are not yet 14.5 years who have had type 1 diabetes for     at least 1 year and who have had at least two visits to diabetes clinics at one of four     clinical sites may be eligible for this study. A total of 120 children will participate in     clinic visits once every 3 months.      Participants and their families will attend diabetes clinic visits once every 3 months. They     will be assigned to one of two groups: standard care or WE CAN. Those in the WE CAN group     will have visits about 15 to 45 minutes longer than those involved in the standard care     group. All participants will have two home visits: at the beginning and at 6 months. There     will also be telephone interviews, about 20 minutes long, once every 3 months with the     children and their parents. Medical data will be collected during each visit to the clinic,     including blood samples. A health advisor will work with the families. Questionnaires given     to parents and children separately will measure diabetes-related family conflict, parent     child sharing of responsibilities for the disease, attitudes and emotions about diabetes, and     impact of the disease on the child's life. Also, parents and children together will take part     in a 10-minute discussion of a diabetes-related issue that has caused friction among family     members. They will discuss the problem, come up with possible solutions, and to try to decide     on a solution within 10 minutes. Family discussions will be videotaped at the first home     visit and at the 6-month home visit.      Families in both groups will receive more detailed monitoring of family diabetes management     than is usually the case. Those in the WE CAN group may be able to control diabetes more     effectively during the child's early adolescence, though that result is not guaranteed. If     the family guidance and support provided by the WE CAN health advisor is effective, children     in that group may have better results in blood sugar than they would if they did not     participate in the study. Each family member completing the first and 6-month visits and     completing each telephone interview will receive payment for participating.   "
191129|NCT00340951|"     This study will evaluate the ability of lung transplant recipients to react to the     transplanted organs. Previous research indicates that some immune tests can identify whether     people are at risk for chronic rejection of transplanted lungs. Certain parameters, that is,     physical properties involving the immune system, may cause acute chronic rejection of the     lungs, which may lead to chronic rejection, a condition of scarring that worsens lung     function. If such parameters can be identified and distinguished from those found in healthy     subjects, information gained can help medical professionals to provide individualized     treatments that work on the immune system. Short-term and long-term survival of lung     transplant recipients may thus be improved.      Patients who will have or have had lung transplants will be recruited by clinical transplant     coordinators. Normal control subjects will be recruited through flyers and newspaper     advertisements.      Collection of blood samples will be done at Duke University Medical Center. Blood collections     will be done of patients undergoing routine pretransplant and posttransplant blood tests, so     no extra blood collections will be required. Control subjects will undergo three blood     collections over an 8-week period. They will be compensated for their time in participating,     at the rate of $5 for the initial blood draw, $10 for the second one, and $15 for the third     one. A small amount of blood is involved, about 3 tablespoons. The blood cells and DNA (which     contains genetic material) will be isolated for analysis. Patients' DNA samples collected     will be identified by a code, and all other identifying information will be removed. The     samples may be used in the future as new tests are developed.      This study will not have a direct benefit for participants. However, during the study, if it     is found that any patients have an inherited risk for a disease likely to cause early death     if the disease is not treated, then the researchers will attempt to notify those patients.     Overall, it is hoped that information gathered will enhance researchers' understanding of     what tests best identify patients at risk for developing chronic rejection of their     transplanted lungs.   "
191130|NCT00340964|"     This study will describe the use of an intervention, developed by an organization called     Positive Exposure, to improve self-perceptions among adolescents and young adults who may     encounter the stigma, or negative effect, of differences in their head and face. Photo-shoots     and video interviews will be used. The combined use of those techniques is a new way to     address aspects such as self-esteem, body image, and feelings of social awkwardness and     anxiety-that is, a way that has never been systematically explored with people who have     craniofacial differences. The conditions that participants in this study have will include     cleft lip and palate, Apert syndrome, hemifacial microsomia, Treacher Collins syndrome,     Mobius syndrome and Sturge-Weber syndrome. Among the goals of photography and video     interviews are to help people to define themselves by their strengths rather than by their     conditions; visually confront discrimination by others; investigate the possibilities for     social support, networking, and creative problem-solving that can be developed for people     with craniofacial conditions; and promote hopefulness for the future. Positive Exposure is a     nonprofit organization founded in 1997. It investigates the psychosocial experiences of     people who have genetic, physical, and mental conditions, among all ages and ethnic and     cultural backgrounds of people. According to experiences of people with several conditions,     participation with Positive Exposure has enhanced their feelings about themselves as     attractive, capable individuals.      Patients ages 12 years and older who have craniofacial conditions may be eligible for this     pilot study. About 30 people will participate. Participants will be asked to provide the     diagnosis of their craniofacial conditions. They will also be asked how many surgeries and     what kinds they have had over the years, and how old they were at the time of the surgeries.     This information will not be connected to participants' names and will be stored in a     database protected by password.      There are three parts to the study. In Part 1, patients will be asked to write a personal     reflection (for as long as they wish) on their experiences of having their picture taken and     being video taped. They will also fill out a brief survey, taking about 15 minutes. They are     able to do this at home and will mail their responses to the researchers. In Part 2, they     will take part in a photo-shoot (about 1 hour) conducted by the founder and program director     of Positive Exposure and then take part in a video interview (about 30 minutes) conducted by     a co-investigator from that organization. In Part 3, to take place 1 month following the     photo-shoot, participants will write a final reflection that describes their experiences with     Positive Exposure and then fill out another brief survey (about 10 minutes). Surveys used in     the study will be the Self-Esteem Scale, Perceived Social Stigma Scale, and State Hope Scale.     Photo-shoots and video interviews will be held at the studio of Positive Exposure in New York     City or, if necessary, at a location closer to the participant's home. The projected time     line of this pilot study is 10 months.      Direct benefits are not the goal of participation in this study. However, participants may     enjoy the photo-shoots and video interviews, as well as the process of reflecting and sharing     their life and photo experiences with others. This pilot study will be a starting point for     future research into Positive Exposure for adolescents and adults with visible genetic     conditions.   "
191131|NCT00340977|"     We propose to conduct a population-based case-control study of facial clefts (cleft lip or     palate) in Norwegian newborns. Cleft lip and palate are one of the most common type of birth     defect, and both genetic and environmental causes have been suspected. This project will     combine tests of recently-discovered genes associated with facial clefting and personal     interviews of the mothers soon after birth. With this information we expect to be able to     assess the combined role of genetic susceptibility and environmental exposures in causation     of facial clefts. We plan to enroll 750 cases and 1100 controls over five years. This will     provide a 2:1 ratio of controls to cases for the largest sub-category of facial clefts (cleft     lip with or without cleft palate).      This study is being conducted as a collaboration between the US National Institute of     Environmental Health Sciences, and the Norwegian Institute of Public Health/Medical Birth     Registry. Norway offers a unique opportunity for carrying out such a study. First, all     Norwegian babies with facial clefts are treated at one of two medical centers at the expense     of the national government. Our collaboration with these two clinics will provide access to     virtually every case born in the country. Second, the Medical Birth Registry maintains a file     of all newborn babies, from which control infants can be randomly drawn from the whole     population. Random population controls are the gold standard for such studies, but are seldom     feasible. Third, blood samples from all Norwegian newborns are sent to one laboratory for     analysis of PKU. Our collaboration with the PKU laboratory will permit mothers of control     infants to consent to the study of their baby's blood without having to submit their baby to     an additional needle stick.      Mothers of cases and controls will be initially contacted through their physicians, and will     be asked to participate in a telephone interview. With their consent, the mothers will also     be asked to provide biological samples for analysis of genes that predispose to facial     clefts. We will collect cheek swabs from control mothers and their infants. Case mothers will     be asked to provide additional blood samples and cheek swabs for more intensive study of     genetic factors within their family. Protection of privacy will be paramount. Mothers of case     infants will be given the option of receiving individual results, but only if a consulting     panel of ethicists and other experts agree that such information will be beneficial.      Analysis and presentation of data will be carried out jointly by US and Norwegian     investigators.   "
191218|NCT00349310|"     To explore or establish the relationship between cognitive, mood and motor symptoms in PD to     scores on depression rating scales in a naturalistic setting.   "
191317|NCT00350649|"     Cognitive-behavioral coping skills therapy (CBT) is a widely used and recognized treatment     that has been empirically validated for a range of substance use disorders, often with     emergent effects and continuing improvement even after treatment ends. Treatment retention     and compliance are associated with enhanced treatment outcomes in CBT. Contingency management     (CM) also has very strong support and is associated with rapid, robust effects on targeted     outcomes. Despite their many strengths, neither CBT nor CM is universally effective. It is     now essential to seek strategies to maximize and extend the effectiveness of these two     approaches and to better understand how these treatments exert their effects.   "
191206|NCT00349141|"     The objective of this study is to assess the safety and immunogenicity of 4 different doses     of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be     enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin     antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg     adjuvanted/non-adjuvanted, 30 µg adjuvanted). Starting with the lowest dose level, subjects     will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Subjects     will be monitored for safety and for antibody response to the vaccine. A data safety     monitoring board will review and evaluate all the safety data obtained for a dose level     before allowing administration of the next (higher) dose.   "
191133|NCT00341003|"     This study, conducted by the National Center for Malaria Control of Cambodia's Ministry of     Health, the Guangzhou University of Traditional Chinese Medicine in the People's Republic of     China, and the U.S. National Institutes of Health, will explore why some people with mild     malaria progress to a severe form of the disease and why some malaria parasites are resistant     to treatment.      Malaria is caused by a parasite that is transmitted to humans through a mosquito bite. It can     cause fever, aches, and weakness. Left untreated, it can cause severe illness and even death.     Malaria can be cured when it is treated with effective medicine, but some malaria parasites     are resistant to medicine.      Children and adults with malaria symptoms and parasites in their blood will be recruited for     this study from the Pursat Regional Health Center in Cambodia and the Thai-Cambodian border     area within Pursat Province.      Participants are hospitalized for 4 to 6 days at the Pursat Regional Health Center. A small     blood sample is collected for genetic study and to look for substances in the blood, such as     certain proteins, that may help protect against severe malaria. Patients are then treated     with two doses of Artequick(Registered Trademark) (artemisinin-piperaquine), the first dose     upon arrival at the hospital and the second the next day. (Participants who are pregnant will     be treated with either quinine or artesunate-mefloquine instead of Artequick.)      Patients undergo fingersticks several times during their hospital stay to collect a small     drop of blood to monitor parasite counts. They are discharged from the hospital when their     symptoms resolve and parasites can no longer be detected in their blood. After discharge,     patients return to the clinic once a week for 3 weeks for a blood test to monitor for     parasites, as some parasites may be slightly resistant to the medication. Patients in whom     symptoms or parasites reappear undergo treatment with artesunate and mefloquine.   "
191134|NCT00341016|"     Leukemia holds a special place in the study of radiation-related cancer because bone marrow     is one of the tissues most sensitive to the carcinogenic effect of ionizing radiation,     radiogenic leukemia has the shortest latent period among radiation-induced cancers, and its     appearance suggests that solid tumors may follow. These same characteristics also contribute     to its considerable significance in radiation protection. There are, nevertheless, important     gaps in existing knowledge of radiation-induced leukemia, gaps that derive from     characteristics of the study of the atomic bombing of Hiroshima and Nagasaki, and from     studies of the effects of medical irradiation and studies of nuclear workers, these being the     studies that have provided most of the information to date. These gaps include the presumed     reduction in risk resulting from dose-fractionation and low dose-rate, and the time-response     function in the first five years after exposure.      The primary objective of this study is to investigate leukemia risk as a function of such     radiation; it would constitute the largest epidemiologic study conducted to date among     working-age males, a group of particular concern in establishing occupational radiation     safety standards. In addition, data on cases of multiple myeloma and myelodysplasia     identified in the cohort will be collected to test the hypothesis of a dose related     association between radiation and increased risk for each of these diseases.      The primary scientific objectives of the proposed study are to test the following hypotheses:     (a) that there is a dose-related increase in risk of leukemia among these liquidators; (b)     that the magnitude of any observed risk per unit dose is less than that seen in the atomic     bomb survivors, exposed to essentially instantaneous radiation.      Subsidiary objectives include: (a) to investigate the nature of the dose-response     relationship among liquidators and to identify modifiers of risk, including time since     exposure, age at exposure, etc.; (b) to test the hypothesis that there is a dose-related     increased risk of multiple myeloma; (c) to test the hypothesis that there is a dose-related     increased risk of myelodysplasial; (d) to collect and store buccal cells from about 2,000     liquidators with a wide range of dose estimates extending to well over 1 Gy for possible use     in future molecular studies of their DNA.   "
191135|NCT00341029|"     This study, conducted at Duke University in Durham, NC, will determine whether the drugs     Adderall and methylphenidate affect the genetic material of children with attention deficit     hyperactivity disorder (ADHD). One small study has shown that taking methylphenidate for ADHD     may result in higher levels of certain types of changes to the genetic material contained in     white blood cells. The changes seen are not directly linked to increased risk of disease, but     indicate a possibility that other kinds of damage that may be linked to increased disease may     result from taking methylphenidate. The study will also examine whether these types of     changes might occur in children treated with Adderall .      Children between the ages of 6 and 12 with symptoms of ADHD may be eligible for this study.     Candidates are screened with a medical history, psychiatric examination, IQ test, physical     examination, and electrocardiogram. Parents and teachers complete questionnaires to rate the     severity of the child's ADHD. Qualified children who are diagnosed with ADHD and who are     appropriate candidates for treatment with either Adderall or methylphenidate-based drugs     (e.g., Concerta, Metadate, Focalin, Ritalin or Ritalin LA) may be selected for this study.      At a baseline visit (Visit 0), parents complete questionnaires that rate the severity of     their child's ADHD. The children have their vital signs checked (pulse, blood pressure,     breathing rate, height, weight and temperature) and have a blood sample drawn. The children     are then randomly assigned to treatment with either Adderall or a methylphenidate product.     After the baseline visit, participants undergo the following tests and procedures:      Dose Optimization Visits (visits 1-4)      In the first 4 weeks of the study, the dose of methylphenidate or Adderall is adjusted weekly     until doctors determine the dose strength that works best for the individual child. In     addition, the following procedures are done at each visit:        -  Child's vital signs are checked.        -  Parents complete a questionnaire about the severity of the child's ADHD.        -  Parent and child describe the impact of symptoms on the child's functioning.        -  Parents complete forms about common side effects of the study drug.      Follow-up Visits (visits 5-6)      Children return to the clinic once a month to assess their health and further adjust their     medication dose, if needed. The visits are similar to those during the dose optimization     period, with the following additional procedures at visit 6:        -  A blood sample is obtained to measure whether the medication has affected the child's          genetic material.        -  A physical examination is done to check child's health.        -  Information is provided parents to assist in planning for child's treatment after the          study.   "
191141|NCT00341107|"     Research and development in genetic testing for cancer susceptibility genes has advanced     rapidly in recent years, allowing healthy individuals, cancer patients, and their families to     determine if they carry mutations which increase their risk of breast, ovarian, prostate,     colon, and other cancers. Initial efforts have unfolded primarily in academic medical centers     targeting families at high risk for cancer. There is currently no information available for     assessing the prevalence of genetic testing for cancer susceptibility genes at the national     level, or for evaluating the knowledge of and attitudes toward such testing among primary     care physicians. The objectives of this survey are to determine the utilization of genetic     tests by physicians at the national level; to ascertain physician knowledge of available     genetic tests for specific cancer susceptibility genes, to examine physicians' general     attitudes toward testing, and; to explore possible variation in utilization and     knowledge/attitudes by medical specialty, type of practice, year of training completion,     board status, urbanicity, and geographic region. The primary research question that this     survey will address is what is the prevalence of use of genetic testing for cancer     susceptibility among primary care physicians in the U.S.? The survey will also assess whether     there are statistically significant differences in 1) self-reported knowledge, current use     of, and future intentions to use genetic testing for cancer susceptibility, and 2)     perceptions of barriers to testing, among primary care physicians by their type and location     of practice, and recency of training. Primary care physicians (internists,     obstetrician/gynecologist, family and general practitioners) will also be compared with     specialty groups (gastroenterologists, surgeons, urologists) and oncologists with respect to     their use, attitudes towards, and knowledge of, genetic testing for cancer susceptibility. A     questionnaire is being administered by mail, telephone, facsimilie or Internet to a     nationally representative sample of 2,100 physicians. Responding physicians select their     preferred response mode. Study participants are primary care and specialty physicians with     active licenses to practice medicine in the U.S. A data file with personal identifiers     deleted will be prepared for statistical analysis to estimate the prevalence and determine     predictors of use and intentions to genetic tests for inherited cancer susceptibility.   "
191148|NCT00341198|"     Autoimmune diseases may involve nearly any organ and are characterized by abnormal activation     or response of certain cells. Evidence suggests that farm work, exposure to silica from     farming activities and exposure to pesticides may contribute to the development of autoimmune     disease. Associations between autoimmune diseases and farming, however, have not been     extensively investigated, and exposure data in the currently available studies are extremely     limited.      One of the major challenges in conducting population-based research on autoimmune diseases is     case ascertainment. Self-report of previous diagnosis has proven to be unreliable. This     protocol outlines a strategy to confirm self-reported diagnoses of systemic autoimmune     diseases (rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and Sjogren     syndrome) within the Agricultural Health Study group (AHS; a group of licensed pesticide     applicators and spouses who completed a questionnaire). The confirmed cases will constitute a     refined case group to allow analyses of pesticides and other farming-related exposures as     possible risk factors for these diseases using data that have already been collected.      Subjects will be selected from participants in the AHS who reported one of the diseases being     studied. A short telephone interview will be conducted with participants, who will be     requested to provide written consent for review of information from medical records. To     confirm the self-diagnosis, participants' physicians will be contacted. Specific information     will be requested in the form of a checklist. Responses will be reviewed for evidence of     diagnosis and classified as confirmed, probable, physician-diagnosed, or unconfirmed.      Secondary objectives of this study are to:        -  assess the correct interpretation of conflicting self-reports that are provided at two          different times.        -  evaluate the usefulness of specific questions that could potentially be used in future          studies to validate self-reported cases of rheumatoid arthritis in men.   "
191136|NCT00341042|"     This study, conducted in Bamako, Mali (West Africa), will collect blood and sputum samples to     establish normal values for laboratory test results among Malians. Researchers are starting a     new initiative to study HIV and tuberculosis in Africa, using Mali as a model country. In     order to perform these studies, the scientists need to know what constitutes normal     laboratory values among the population. People in developing countries may have dramatically     different laboratory values from those who live in developed countries, and there is     currently little information available to distinguish normal from abnormal results in     Malians. This study will establish normal ranges that will provide a basis for future HIV and     tuberculosis research in Mali. Additionally it will provide blood and sputum samples to     researchers to study different scientific questions related to HIV and Tuberculosis     infection.      Healthy volunteers and people infected with HIV or tuberculosis, or both, who are 18 years of     age or older and who live in Bamako, Mali, may be eligible for this study. Candidates are     screened with a medical history, physical examination, and blood test.      Participants provide a blood or sputum sample, or both, for laboratory analysis. Blood is     collected through a needle inserted into an arm vein, and sputum is collected by having the     participant cough deeply and spit in a cup. Participants may agree to provide samples one     time only or on a returning visit basis. Returning visits may be scheduled daily or weekly.     Subjects may continue to participate for the duration of the 4-year study, provided their     medical history and physical examination are updated once a year.   "
191137|NCT00341055|"     The purpose of this study is to evaluate the hematologic response, safety, and clinical     outcomes of PROCRIT administered once a week in anemic cancer patients receiving     chemotherapy.   "
191138|NCT00341068|"     In a collaborative effort with the Health Research Board, the national organization for     medical research in the Republic of Ireland, individuals with neural tube defects (NTDs) or     facial cleft defects and their parents will be studied. With the exception of a few     well-described syndromes most cases of NTDs and facial clefts are not inherited in a     Mendelian fashion. Nearly all incident cases occur in families with no prior history of the     defects. The observed recurrence risk in families with an NTD child is 10-12 fold higher than     the general population suggesting that inherited factors modify this risk. Historically, the     incidence of NTDs in Ireland was 5-8 fold higher than the USA. The aim of this study is to     identify the gene(s) involved in these defects using standard genetic epidemiology     approaches, transmission disequilibrium testing and gene mapping strategies. We will     initially evaluate genes known to be involved in folate metabolism and pattern formation     (development of the body). The major outcomes measured will be aggregate allele frequencies     in case groups compared to controls. Biochemical parameters in red cells and plasma will also     be measured. Comparisons will be made between the presence of genetics variants, biochemical     parameters and clinical phenotype. Characterizing the genes associated with these defects     should provide insight into the etiology and metabolic processes that may be involved,     furthering prevention and intervention efforts.   "
191139|NCT00341081|"     This study, conducted at the Johns Hopkins University School of Public Health in Baltimore,     Maryland, will determine how accurately injection drug users report their needle-sharing     behavior. Needle-sharing is a major cause of blood-borne diseases, including HIV and     hepatitis. Therefore, a better understanding of this behavior is critical for devising     strategies to reduce disease spread in this way. Research on needle-sharing behavior has     relied heavily on users' self-reports. This study will compare these self-reports with     results of DNA tests that show whether a needle has been used by one or more individuals.      Injection drug users 18 years of age or older participating in the Baltimore Needle Exchange     Program (BNEP) have been recruited for this study. Syringes distributed to users through the     BNEP are collected after use and tested to differentiate between single versus multiple     users. The findings are compared with the participants' responses about whether or not they     shared their needles and syringes.      Participants visit the clinic every 6 months for an interview, including questions about     their mental and physical health, drug use, sexual activity and knowledge about HIV (the     virus that causes AIDS) and AIDS. After the interview, a small amount of blood is drawn for     testing for HIV, hepatitis, syphilis and other infectious diseases. Some of the blood is     stored for future testing. Participants return to the clinic 4 weeks after the interview and     blood drawing to get their test results. At this time, they are offered referral for drug     treatment, free condoms, advice about drug use and safer sex and an opportunity to ask     questions about their health. Participation in the study may continue for up to 5 years.   "
191140|NCT00341094|"     The nuclear power plant accident at Chornobyl released large quantities of Iodine-131 and     other radioisotopes of iodine in the atmosphere, contaminating thousands of square kilometers     and exposing millions of people. For this study, a well-defined subset of Ukrainian children     aged 0-18 years or in utero at the time of the accident are being identified and examined by     well-trained specialists for thyroid disease every two years for at least three cycles. The     study is a collaborative effort of research in Ukraine and the United States.      The cohort will include approximately 13,000 persons who were children in 1986, all or most     of whom have had their thyroids measured for radioactivity during the weeks immediately     following the accident (or whose mothers had measurements taken while the child was in     utero). Under a rigid research protocol these subjects will receive diagnostic thyroid     examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory     tests, and, if indicated, fine-needle aspiration biopsy. Interview information regarding     residential, health, diet and lifestyle history will also be collected. All subjects will be     followed for thyroid cancer morbidity and mortality. Thyroid cancers will be confirmed by     expert pathology examination of tissue.      In addition to the analysis of thyroid radiation measurements made in May-June, 1986, efforts     will be made to reconstruct each person's exposure and to estimate the radiation dose to the     thyroid. This will involve the reconstruction of deposition patterns and environmental     pathways of the radioiodines, and of the location, dietary characteristics, and lifestyle of     each person throughout the exposure period.      The aim of the study is to carry out valid and credible assessments of the early and late     morphologic and functional changes in the thyroid glands of persons exposed to radiation from     radioactive materials released as a consequence of the Chornobyl nuclear power plant     accident. The emphasis is on dose- and time-specific changes.      In the course of the study other possible risk factors will be examined including dietary     iodine intake during and after 1986, and the ingestion of potassium iodide for thyroid     protection shortly after the accident.   "
191237|NCT00349557|"     The purpose of this study is to determine the acute and late toxicities from radiation     therapy in combination with bevacizumab (given every 2 weeks for 16 weeks then every 3 weeks     for 12 weeks), bicalutamide (every day for 16 weeks) and goserelin (every 3 months for 2     years).   "
191318|NCT00350662|"     Comparison of efficacy and toxicity of the combination treatment of deferiprone and     desferrioxamine with the single agent treatment of either drug   "
197108|NCT00428948|"     This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus     placebo in patients with ADPKD.   "
191143|NCT00341133|"     The objective of these studies is to identify genetic factors that contribute to the     pathogenesis of complex congenital heart disease and other more rare conditions resulting     from disturbances in organ positioning. These are a group of medical conditions that are     thought to stem from a poorly understood disturbance in the establishment of the basic body     plan in the embryo. While the outside of the human body is generally symmetric with mirror     image left and right sides, the positions of some internal organs are distinctly asymmetric.     For example, the heart could not function properly as a mechanical pump if its connections to     major blood vessels retained their initial symmetry. The left ventricle of the heart normally     pumps blood to the body, while the right ventricle normally pumps blood to the lungs.     Reversals in these blood vessel connections can be fatal. Similarly, the gut     characteristically loops in a counterclockwise direction placing the stomach on the left side     in most cases. Rare laterality anomalies can occur if this looping is in the other direction,     or randomized (equally likely to loop in either direction). Serious medical problems can be     caused by disturbances in the establishment, or maintenance of left-right (L-R) differences     as key organs are developing in the embryo.      We have established formal collaborative agreements with three major centers who have     collected a large number of coded cases of congenital cardiac disease. Our research objective     is to try to understand if specific genetic changes can contribute to a range of cardiac     malformations. We utilize mutational analysis of candidate genes as our principal tool to     study the genetics of L-R axis malformations. This protocol is also open to other conditions     whose basis is also thought to result from L-R problems. In all cases, the patients continue     under the care of the referring physician. We anticipate a minor role of NIH researchers and     genetic counseling services if subjects either do not have, or cannot afford, similar     services in their local area.      This is not a treatment protocol. Our empiric ability to generate medically significant     research results is limited by the extensive genetic and other etiologic heterogeneity.     Therefore, this research is not a diagnostic study. At this stage of research, we are not     sufficiently confident that our research results will have direct medical implications for     research subjects.      Results that are of potential medical importance will be discussed with the primary physician     who is (in most cases) a trained cardiologist (and/or medical geneticist). We will emphasize     that these are only preliminary research findings, that they are not CLIA-approved, and must     be disclosed to the patient or included in the medical record. Repeat testing in a     CLIA-approved lab under another protocol would be required before the genetic information     could be shared with the patient and family.   "
191144|NCT00341146|"     The objective of this study is to characterize genes associated either with susceptibility or     resistance to the development nasopharyngeal carcinoma (NPC) in a Chinese population where     the incidence of NPC is as high as 50 in 100,000. NPC has been and remains a unique model of     human malignancy for understanding a multi-step carcinogenic process involving a ubiquitous     virus (Epstein-Barr virus), environmental carcinogens, and an NPC susceptibility gene. Up to     95% of all NPC patients at early or late stage of the disease have IgA antibodies directed to     the EBV virus VCA (viral capsid antigen). Environmental factors have also been implicated as     significant risk factors in the development of NPC. In addition, certain alleles in HLA genes     have shown associations with NPC, perhaps in concert with a family of T-cell receptor genes     (TCR). Other data suggest that a microsatellite marker on Chromosome 6 may be associated with     an NPC-disease associated gene.   "
191145|NCT00341159|"     This study will continue to analyze data collected by the Women's Contraceptive and     Reproductive Experiences (CARE) study. The CARE study was designed to evaluate the     association between reproductive factors and risk of breast cancer in white and     African-American women in the United States.      The present study is not recruiting additional participants. The original study enrolled     4,575 women with breast cancer and 4,682 control subjects between 35 and 64 years of age      All participants provided a blood sample for genetic study. The samples were analyzed for     variants (mutations) in the BRCA1 and BRCA2 genes, the vitamin D receptor gene, the androgen     receptor gene, and the insulin-like growth factor-1 gene.      In addition, all participants were interviewed to obtain information related to breast cancer     risk, including a history of reproductive, menstrual, oral contraceptive, and hormone     replacement therapy use; lifestyle factors such as smoking, alcohol use, body weight, and     physical activity; history of medical conditions and procedures; demographic characteristics,     such as age, race, marital status, and so forth; and a detailed family history of cancer.   "
191146|NCT00341172|"     This study will evaluate the role of certain gene variants on the onset and course of     cytomegalovirus (CMV) retinitis-a severe infection affecting the eye-in patients with AIDS.     Symptoms include blurry vision, eye pain, photophobia, floaters, eye redness, and impaired     vision. Left untreated, it can cause blindness. The study is done in collaboration with     investigators of the Longitudinal Studies of the Ocular Complications of AIDS (LSOCA) at the     Johns Hopkins University School of Medicine. The purpose of the LSOCA study is to learn about     how HIV and other infections associated with AIDS and their treatments affect people's eyes     and sight.      Blood samples previously collected from patients participating in the LSOCA study will be     analyzed for gene variants. These differences will then be correlated with the patients'     clinical data to try to discover the role of gene differences among patients on the     following: susceptibility to CMV and related problems; development and course of CMV; and     response to HAART (highly active antiretroviral treatment), particularly in CMV onset and     pathology.      The study will use blood samples and clinical information previously collected from patients     during their participation in LSOCA. The materials will be identified with a numerical code     linking the samples and clinical data. No additional procedures will be performed on patients     for this study.   "
191147|NCT00341185|"     We propose to study the prevalence of thyroid nodules and cancer in relation to radiation     dose, in a defined cohort of Kazakhstan residents exposed as children to radioactive fallout     from atomic bomb tests at the neighboring Semipalatinsk Test Site (STS). The population near     the STS is believed to have received radiation doses from fallout that were much higher than     that experienced by any population of comparable size in the US. The study population is a     defined cohort of 20,000 residents, half of whom, in 1960, resided in heavily-exposed     villages; the other half lived in lightly-exposed villages. The population is rural, with a     diet that was and is heavily dependent upon fresh milk from household or local cows and     therefore likely to have led to ingestion of radioactive iodine from fallout. The study is     two parts.      The first part involves a cytogenetic assay for radiation biodosimetry purposes of peripheral     lymphocytes obtained from blood samples donated by 40 cohort members with individuals     radiation dose estimates. Blood samples will be collected from 25 putative high-dose and 15     low-dose cohort members and processed or cytogenetic assay using fluorescent in situ     hybridization (FISH) for stable chromosome aberrations in peripheral lymphocytes. This     biodosimetric validation assay, will be carried out by Nailya Chaizhunusova, chief of     cytogenetics at the Scientific research Institute for Radiation Medicine and Ecology, in     collaboration with Dr. Tracy Yang at the NASA Johnson Space Center in Houston, Texas. It     should be possible to detect gamma radiation doses as low as 150 mGy.      The second part will involve thyroid screening by ultrasound in selected villages. The     population to be screened will comprise 100-1500 members of the study cohort exposed as young     children to high fallout levels, and equal numbers of comparable ages exposed to little or no     fallout. Fine needle aspiration biopsy will be performed, under separate informed consent, if     the palpation and ultrasound results suggest presence of a tumor. Presence and malignancy of     tumor will be determined by cytopathology. Subjects with evidence of thyroid disease will be     referred to thyroid specialists at the Semipalatinsk State Medical Academy. Finger stick     blood samples will be obtained to assess thyroid function using RIA methods with coated tube     technology for T4 and TSH. The most sensitive statistical comparisons are expected to be     dose-response analyses with respect to prevalence of thyroid nodules, which are common and     known to be associated with radiation dose. Comparisons in terms of thyroid cancer, and     benign and malignant neoplasms combined, are likely to be less sensitive but of acceptable     power if risks associated with chronic radiation in this population are similar to those     associated with acute exposure to X-ray or gamma radiation in other populations.   "
191284|NCT00350181|"     To evaluate the incidence of grade II-IV acute GVHD with sirolimus and mycophenolate mofetil     GVHD prophylaxis.   "
191150|NCT00341224|"     As an antidote to juvenile aggression and violence, which has increased in recent years,     group mentoring offers a viable alternative to intensive one-on-one mentoring. However, no     group-mentoring programs have been evaluated.      The purpose of this study is to assess the efficacy of a school-based, group-mentoring     intervention designed to prevent aggressive and deviant behavior among early adolescents.      Study participants will be incoming 6th grade students from two inner-city Baltimore middle     schools and their parents. Approximately 1,400 students and their parents are expected to     participate. All 6th grade students in these schools are eligible for the study.      Weekly student group-mentoring sessions are the principal component of this study. These     groups will be held during the school day and will be designed to increase social skills and     encourage academic engagement, restraint, and problem-solving. A master's level professional     will direct and conduct these intervention activities, which will employ the use of field     trips, cooperative games, discussion of real-life situations, and role playing.      Students will also complete a 1-hour written survey each fall and spring from grades 6-8     about the program and about attitudes and behaviors related to school involvement and staying     healthy and safe. Study staff will contact participants' teachers and review their past and     current school records, including attendance, grades, and disciplinary information.      Parents may be asked to participate in group meetings and will complete in-person or     telephone interviews (about 20 minutes each) about similar information over a 3-year period     (6th grade to 8th grade).   "
191151|NCT00341237|"     This study conducted by the NIEHS and the University of North Carolina Medical Center will     create and maintain a biorespository containing the genetic material (DNA) from up to 20,000     individuals recruited from North Carolina. These samples will allow scientists to look for     differences in each individual s DNA. These differences are not known to be associated with     any condition or disease to date, but the purpose of the study is test these differences for     possible susceptibility to (or protection to) common conditions such as asthma,     cardiovascular disease, cancer and many others. Many of the differences to be studied are in     environmental response genes. These genes determine the various ways humans respond to toxic     substances in the environment, their diet and lifestyles (e.g. no exercise vs. exercise), and     exposures to other substances, e.g. therapeutics.      Participants will be recruited from the general NC population through health fairs, studies     drives at community venues and corporations, and from out patient clinics within the     University of North Carolina health care system. Participants can also visit one of two     locations in the Research Triangle area to volunteer for this study. All participants will be     asked to provide a blood sample and some basic information on their gender, race and     ethnicity, and will be compensated for their time by receiving $20.      DNA will be extracted from the blood, encrypted with a secret identification number, and     placed in the registry's biorepository. The registry will exist for up to 25 years. During     that time, the DNAs will be available to researchers to look for the differences in the DNAs     as described above. Participants who have certain differences might be asked to participate     in a future study of people with the same DNA differences. The future studies will most     likely involve filling out a questionnaire or participating in a telephone survey, but may     involve being interviewed or having a physical examination or laboratory evaluation,     including blood tests. Participants will be asked to update their contact information once a     year for up to 25 years.   "
191152|NCT00341250|"     This study will test an experimental vaccine called AMA1-C1 in children to see if it is safe     and if it reduces episodes of malaria parasitemia (parasites in the blood) in children     exposed to malaria. Malaria affects about 300 million to 500 million people worldwide each     year, causing from 2 million to 3 million deaths, mostly among children less than 5 in     sub-Saharan Africa. It is the leading cause of death and illness among the general population     of Mali in West Africa. Increasing drug resistance to the malaria parasite and widespread     resistance of mosquitoes (the insects that transmit the parasite) to pesticides are reducing     the ability to control malaria through these strategies. A vaccine that could reduce illness     and death from malaria would be a valuable new resource in the fight against this disease.     AMA1-C1 is an experimental vaccine developed by the NIAID. Tests of AMA1-C1 in 87 healthy     people in the United States and in Mali found no serious harmful side effects of the vaccine.      Two- and three-year-old children who live in Don gu bougou or Bancoumana, Mali, and are in     general good health may be eligible for this study. Candidates are screened with a medical     history, physical examination, and blood and urine tests.      Participants are randomly assigned to receive two injections (shots) of either AMA1-C1 or a     Haemophilus influenzae type B vaccine called Hiberix® (Registered Trademark), which is     approved and used in Mali. All shots are given in the thigh muscle. Before the first shot, a     small blood sample is obtained to make sure the child is well and to see if he or she has     antibodies to the malaria parasite. The second shot is given 4 weeks after the first. After     each shot, participants are observed in the clinic for 30 minutes. They return to the clinic     1, 2, 3, 7 and 14 days after each shot for a physical examination. Blood samples are drawn at     some visits to check for side effects of the vaccine and to measure the response to it.      During the rainy season after the second vaccination, subjects come to the clinic once a     month for an examination. Any child who has been ill with a disease that could be malaria has     a blood sample collected by fingerstick to test for malaria and to learn about the malaria     parasites causing the infection. Every fourth visit a fingerstick sample is taken regardless     of whether the child has been sick. If a child becomes sick at any time during the study, he     or she will be brought to the clinic for examination a...   "
191285|NCT00350194|"     The purpose of this study is to determine the effects of omega-3 fatty acids in the form of     fish oil supplementation (approximately 2 grams per day) on the carotid intima-media     (CIMT)progression (primary objective) and 2)(Secondary objective) lipid markers such as LDL,     apo-B, and LDL buoyancy, on inflammatory burden as measured by CRP, on oxidative stress as     measured by urinary isoprostanes, urine microalbumin/creatinine, and serum adiponectin a fat     derived hormone in subjects with metabolic syndrome.   "
191153|NCT00341263|"     This study will examine levels of hormones, such as estrogen and testosterone, in maternal     and umbilical cord blood to compare hormones between mothers who are having twins and mothers     who are having one baby. It will investigate whether hormone levels in twin versus singleton     pregnancies influence the babies' risk of developing breast, prostate, and testicular cancers     later in life.      Pregnant women 18 years of age and older who do not have preeclampsia, chronic hypertension,     pre-pregnancy or gestational diabetes, thyroid disease, or other major pregnancy     complications are eligible for this study. Participants will be recruited from the obstetrics     and gynecology practice at the Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire.      Participants will have a blood sample drawn from their arm during their third trimester     prenatal visit and again when they are admitted to the hospital for delivery. After the baby     is born, a blood sample will be collected from the cut umbilical cord. Information about the     pregnancy and delivery will be collected from the mother's medical chart, and information     about the baby's size will be obtained from the baby's medical chart.   "
191207|NCT00349167|"     RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 in treating     patients with advanced solid tumors.   "
191208|NCT00349180|"     This study is performed to confirm the optimal dose for THR (total hip replacement).   "
191209|NCT00349193|"     Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has     immunomodulating properties. In a previous clinical study laquinimod showed evidence of     biological activity by reducing the number of acute brain lesions.      The duration of the current study is 36 weeks.   "
191154|NCT00341276|"     The overall goal of this project is to understand the role of genetics in the etiology and     prevention of upper gastrointestinal cancer, primarily esophageal cancer, but also cancers of     the gastric cardia and body.      Esophageal cancer is the second most common cause of cancer death in China and the seventh     most common cause of cancer death worldwide. Evidence suggests that genetic factors may play     an important role in the etiology of this malignancy, and identification of esophageal cancer     susceptibility genes may allow screening of populations to identify persons at particularly     high risk, who could then be targeted for prevention strategies (e.g., chemoprevention or     early detection). There are several lines of evidence supporting the idea that there is     genetic susceptibility for esophageal cancer in high-risk Chinese populations, including an     association of positive family history with increased risk, evidence of familial aggregation     of cases, and segregation analyses suggesting Mendelian inheritance in high-risk families.      Several different but complementary approaches will be used to identify esophageal cancer     susceptibility genes. (Because of etiologic similarities and for logistic reasons, parallel     efforts will be made with gastric cardia and body cancers.) First, a tumor/non-tumor study     will be conducted in which a biological specimen bank consisting of samples (tumor,     non-tumor, venous blood, finger stick blood, and buccal cells) from several hundred cases of     esophageal, gastric cardia, and gastric body cancers will be developed in Taiyuan that can be     used for the identification of esophageal (as well as gastric cardia and body) cancer     susceptibility genes and potential early genetic markers of these cancers. High-density     genome-wide scans with microsatellite markers will be used in a limited number of cases to     identify potential hot spots followed by further testing of these hot spots and other     candidate markers in additional tumor/non-tumor samples. Premalignant morphologic lesions     will also be examined. Second, blood samples for DNA will be collected from approximately 100     healthy individuals from high-risk (Yangcheng County) and low-risk (Beijing) areas to examine     potential population differences in polymorphisms for selected genomic markers. Third, a     large case-control study with cancers of the esophagus, cardia, and body of stomach will be     conducted to evaluate polymorphisms in the candidate markers identified in other components     of this project, and to evaluate gene-environment interactions. Finally, a family study will     be conducted to evaluate linkage of candidate markers with cancer in families having 2 or     more cases with cancers of the esophagus, cardia, and/or body of stomach.   "
191155|NCT00341289|"     This study will examine the relationship between swimming lessons, swimming ability, and     other risk factors or protective factors, and the risk of drowning among children. The     study's primary focus is on children between 1 and 4 years of age, with a secondary focus on     older children up to 19 years of age. Drowning is the second leading cause of accidental     death among children under 5 years of age, with drowning rates peaking among 1- to 2-     year-olds.      The study will examine the circumstances of cases of children between 1 and 19 years of age     who have drowned in a body of water where swimming ability might have been a risk factor,     such as a pool, Jacuzzi, hot tub, pond, lake, river, canal quarry, irrigation ditch, dam, or     ocean. (Drowning is defined as death from asphyxia while submerged, or within 24 hours of the     submersion.)      The victims' parents or guardians will be interviewed about their child's general health,     temperament, motor development, swimming ability, history of swimming lessons, and exposure     to water. In addition, they will be asked about environmental factors related to the child's     drowning, such as if a lifeguard was present or if, in the case of a pool drowning, there was     a fence around the pool. They will be asked about parental norms regarding child supervision     and pool-provider advice regarding swimming instruction. Parents of older children will be     asked about their child's risk-taking and sensation-seeking behaviors. Information on     additional risk factors, such as the remoteness of the site of the drowning and the victim's     blood alcohol level will also be obtained.      The above information will be compared with similar information gathered from parents of     control subjects-that is, children who are the same age as the victims and who live in the     same geographic area. For adolescent cases, information about swimming in unguarded sites or     drinking alcoholic beverages while in or around water will be obtained from direct interviews     with adolescents, as parents may not have accurate information in these areas.      The information gained from this study will provide guidance for the development of     interventions to prevent childhood drowning.   "
191156|NCT00341302|"     By the end of 1999, it was estimated that 1.2 million children were living with HIV     infection. During 1999 alone, 600,000 children were newly infected with HIV, mostly in     less-developed countries. Most HIV-infected children are infected by transmission from mother     to child during pregnancy, at birth, or through breast milk. Antiretroviral medications,     cesarean section before rupture of membranes, and avoidance of breastfeeding are ways to     reduce the risk of transmission. This study will determine mother-to-child transmission rates     and the effects on infants of exposure to antiretroviral medications and mode of delivery.      Approximately 180 to 240 HIV-infected pregnant women in Mexico and Argentina will be enrolled     during the first year of this 5-year study. HIV-infected women will be evaluated during     pregnancy, during delivery, and 6 months after delivery. At each visit, a history will be     taken and physical examination given; blood will be collected for laboratory tests.      HIV-exposed infants will be evaluated through 6 months of age. At each of 2 visits, a history     will be taken and physical examination given; blood will be collected for laboratory tests;     and growth will be assessed.   "
191157|NCT00341315|"     This study will collect information on the height and weight of women who participated in a     1998 study in Triana, Alabama, on the risk of breast cancer and benign breast disease in     relation to environmental exposure to the pesticide DDT and similar chemicals. This     additional information is needed to calculate the participants' body mass index (BMI), which     is required for completing analysis of the data.      The 1998 study-a collaborative effort of the National Cancer Institute, the Triana Area     Medical Fund, and the College of Nursing at the University of Alabama at     Huntsville-investigated possible effects of DDT and other compounds on the risk of breast     cancer, predominantly among African-American women in the area of Triana, Alabama. The study     was initiated as a result of medical findings showing high blood levels of DDT among the     local population who had consumed fish from a tributary of the Tennessee River that had been     polluted by the discharge over several decades of large quantities of pesticides from a DDT     production plant.      Women participating in the study had a mammogram, physical examination, breast examination,     and blood draw, and completed a questionnaire on diet and lifestyle factors. In order to     complete analysis of the data and determine whether there is an association between     environmental exposure to DDT and related chemicals and breast cancer risk, additional     information on BMI is required.   "
191158|NCT00341328|"     The purpose of the study is to evaluate the efficacy and safety of Mycobacterium w in new     lung tuberculosis patients. Mycobacterium w is a strain of bacterium which is being used as     vaccine and adjunct drug against leprosy. This agent has also been found to be useful in the     treatment of lung tuberculosis in limited number of patients.      We are conducting this study in category-I patients( As per World Health Organization,Geneva     classification of tuberculosis) having lung tuberculosis to see the efficacy and also to see     any change in the immunological parameters.   "
191203|NCT00349102|"     The purpose of this study is to evaluate the interest of breath holding for the prevention of     radiation pneumonitis following conformal radiation therapy.      Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath     holding during conformal radiation.      The primary objective of the study is to establish the efficacy of breath holding, compared     to free breathing, in the prevention of early pulmonary toxicity following conformal     radiation.      Several departments of radiotherapy, many pneumology units and two basic and applied research     laboratories take part in this multicentric study.      The number of patients required to demonstrate a reduction in radiation pneumonitis from 45 %     to 22.5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per     arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion     period should be approximately 3 years.   "
191880|NCT00358124|"     To compare the glycemic control, as measured by HbA1C, between insulin glargine and     rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and     metformin   "
191159|NCT00341341|"     This study will explore beliefs and knowledge about genetics and smoking among smokers who     have a first or second degree relative with advanced lung cancer, and whether their     understanding of genetic risk influences their desire to quit smoking.      Healthy adult smokers between 18 and 55 years of age who are first or second degree relatives     (e.g., siblings, children, grandchildren, nieces, nephews, grandnieces or grandnephews) of a     patient with advanced lung cancer who is receiving care at the Moffitt Cancer Center and     Research Institute in Tampa, Fla. and the GUMC/LCCC, may be eligible for this study.     Participants must be able to complete computer online surveys.      Participants log on to a password-protected website to complete online educational sessions     and surveys. The educational sessions include information on: 1) the role of smoking and     genetics in the development of lung cancer; 2) glutathione S transferase (GSTM1), an enzyme     made by the GSTM1 gene that cleans up toxins such as cigarette smoke and that may play a     role in preventing lung cancer from developing; 3) pros and cons of being tested for GSTM1;     and 5) a series of questions and answers about genetic testing. Participants are offered free     genetic testing for GSTM1, and those who wish to be tested are sent materials to collect a     sample from inside the cheek using a mouth rinse and return it to a laboratory at Duke     University Medical Center. They later receive their results online.      Participants also complete online surveys that ask about their risk perceptions, beliefs and     attitudes related to lung cancer, emotional responses to their relative's diagnosis, smoking     history and motivation to quit, reactions to information about smoking and genetic risk, and     interest in receiving smoking cessation services. They are asked to review depictions and     descriptions of smoking cessation materials offered through a quit smoking program at Duke     University Medical Center and to evaluate the extent to which the various materials might be     helpful. They are offered additional information among categories they can choose from.      Participants are surveyed again by telephone 6 months after completing the online surveys.   "
191160|NCT00341354|"     This study, conducted at the San Gerardo Hospital in Milan, Italy, will examine whether a     bacteriocidal-coated endotracheal tube (breathing tube) cleaned with a device called a Mucus     Shaver is safe and effective in preventing hospital-acquired infections in patients who     require prolonged mechanical ventilation in an intensive care unit (ICU).      Pneumonia is the most frequent hospital-acquired infection in the ICU; its development is     likely related to the use of a breathing tube. The tube is placed in the patient's trachea     (windpipe) to assist breathing during and after an operation. Currently, breathing tubes in     intubated patients are cleaned with a suction catheter that draws out secretions that     accumulate in the tube. This method does not clean the tube completely, however, and within a     few hours after the breathing tube is placed, bacteria may begin to grow inside the tube.     Over time, as the patient breathes in and out through the tube, the bacteria may break free     and enter the lungs, possibly causing pneumonia. In addition, the growth of bacteria in the     tube decreases the size of the airway passage, making it more difficult to keep air moving in     and out of the lungs.      Previous studies have shown that breathing tubes coated with silver-sulfadiazine prevented     bacterial growth in the patient's airways and that use of the Mucus Shaver prevented     accumulation of secretions in the lumen of the breathing tube, keeping the tube open. This     study will determine if use of the coated tube and Mucus Shaver in patients requiring     prolonged mechanical ventilation is safe and if it can reduce bacterial growth, the length of     intubation and mechanical ventilation, the occurrence of pneumonia and the length of time in     ICU and hospital.      Patients at San Gerardo Hospital who are 18 and older, who expect to have a breathing tube in     place for more than 48 hours, and who are not allergic to silver-sulfadiazine may be eligible     for this study.      Participants are randomly assigned to have either a standard breathing tube and standard     cleaning or a coated tube cleaned with a Mucus Shaver. At intubation, a sample of secretions     is collected from the mouth, the lumen of the breathing tube, and the airways. The lumen of     the breathing tube is then cultured every day. When the tube is removed, or on the eighth day     of intubation, a sample of secretions is collected from the mouth, the lumen of the breathing     tube, and the airways. After the tube is removed, it is examined for biological and     microscopic analysis.   "
191161|NCT00341367|"     This study attempts to identify genes that may increase or decrease the likelihood of sciatic     pain (shooting pain down the leg) persisting 1 year after treatment of a herniated spinal     disc. Many proteins in the nerves, spinal cord, and brain are involved in processing pain.     These proteins vary slightly in different people. Animal studies have shown that rats and     mice with certain types of proteins experience chronic pain after sciatic injury while those     with other types do not. Better information about the role of genes in pain processing may     lead to a test for the risk of chronic pain for specific individuals and more effective     treatment approaches.      This study will include people who participated in the Maine Lumbar Pain Study of the natural     history of spinal pain. The Maine study included patients treated for sciatic pain caused by     a herniated disc. In this study, patients who did not improve with medical treatment were     referred for surgery to remove the disc. Of those referred for surgery, 275 elected to have     the operation, and 232 did not. One year after surgical consultation, leg pain was reduced in     81 percent of patients who underwent surgery. Of those who declined surgery, 56 percent     improved after 1 year. This study will look for genetic differences in the non-surgical group     that might reveal differences among those who improved and those who did not.      Participants will provide a blood sample (approximately 2 tablespoons) for genetic testing.     They will also provide information on the ethnic background of their parents and     grandparents. Different gene variants occur in different ethnic groups, so information on     ethnic background will help researchers know what gene variants to look for. Participants     will complete a questionnaire about their smoking history, because the same protein in the     brain that responds to nicotine may also play a part in decreasing or increasing pain. Also,     some surgeons believe that smoking can interfere with spinal bone healing. Information from     this study will help resolve this question.   "
191162|NCT00341380|"     This study will investigate operative techniques to reduce the risk of tumor spread as a     result of lung cancer surgery. Recent studies indicate that tumor cells may be released into     the bloodstream due to handling of the lung during surgery, causing disease spread in     patients whose tumor was previously confined to the lung. This study will examine whether the     order in which the pulmonary vein (a vessel carrying blood from the lungs to the heart) and     artery (vessel carrying blood from the heart to the lungs) are tied off during surgery     affects the risk of tumor spread and disease recurrence.      Patients 18 years of age or older with operable Stage I or Stage II non-small cell lung     cancer and no evidence of tumor spread beyond the lung may be eligible for this study.     Candidates will be screened with a medical history, blood tests, chest X-ray, and possibly     mediastinal evaluation. This test involves inserting a tube into the chest cavity to look for     signs of disease spread beyond the lung.      All participants will undergo standard surgery for lung cancer. During the procedure, both     the pulmonary artery and pulmonary vein are tied off; for this study, patients will be     randomly assigned to have either the artery or the vein ligated first. Patients will be     followed every 6 months for two years with blood tests and X-rays to look for disease     recurrence.   "
191163|NCT00341393|"     This study will evaluate a system for predicting the effectiveness of antiretroviral     treatment in African HIV clinics where standard testing methods for measuring viral load,     such as RNA polymerase chain reaction, are not available or affordable. Without accurate     tests to monitor viral load, treatment decisions often are based on insufficient clinical and     immunologic information. This study will see if combined analysis of patients' antiretroviral     treatment history, adherence to treatment, clinical findings and simple laboratory tests can     predict whether their treatment is effectively lowering their viral load. An effective     monitoring system such as this could reduce the number of patients kept on ineffective     treatments for prolonged periods of time as well as reduce the development of drug     resistance.      HIV-infected patients 18 years of age and older who are being followed in the Adult     Infectious Disease Clinic at Makerere University, Kampala, Uganda, and who have been taking     antiretroviral treatment for more than 6 months may be eligible for this study.      Participants' medical charts are reviewed and their medical history is taken, including     questions about their treatment history, adherence to treatment, and changes in symptoms. A     blood sample is drawn to determine viral load, CD4+ and CBC counts, and, if necessary,     anti-viral resistance.   "
191164|NCT00341406|"     This study, conducted at Stanford University in Palo Alto, California, will examine how     insulin metabolism and cardiovascular risk are altered in response to weight loss. Insulin is     a natural hormone that causes cells to remove glucose (sugar) from the blood. People who are     insulin-sensitive remove glucose efficiently. People who are insulin-resistant require more     insulin to remove glucose from the blood.      Adult volunteers will be recruited for this study through advertisements in local newspapers     in communities around Stanford University.      Participants will undergo the following tests and procedures:        -  Insulin sensitivity testing: Before beginning the study, participants will be tested for          insulin sensitivity. For the test, two small catheters (plastic tubes) are placed into          two veins - one for infusing glucose, insulin, and sandostatin (a drug that blocks          insulin secretion from the pancreas), and one for drawing blood samples. The infusions          are done over 3 hours. Blood samples are collected before, during, and at the end of the          study to measure how well the cells remove glucose from the blood in response to          insulin.        -  Research diet: Participants are assigned to a low-calorie diet tailored to the          individual's metabolic rate. The diets contain either 40 or 60 percent of total calories          as carbohydrates, 40 or 20 percent as fat, and the rest as protein. People with type 2          diabetes who are taking diabetes medicine with have a diet of 45 to 50 percent          carbohydrates, 35 to 40 percent fat, and the rest protein.        -  Meal profile: Before beginning the diet and after 4 months on the diet, participants are          tested for the effects of the various study diets on control of blood sugar and fats. On          the day of each test, participants have a physical examination and provide a medical          history. Then, a small catheter is placed in a vein. Blood samples are drawn before          breakfast and then hourly for up to 8 hours.        -  Participants who are diabetic are randomly assigned to take one of three diabetes          medications - rosiglitazone, glucophage, or a sulfonylurea compound - to help control          blood glucose levels.        -  Magnetic resonance imaging: This diagnostic test uses a strong magnetic field and radio          waves to show structural and chemical changes in tissues. During the scan, the          participant lies on a table in a narrow cylinder containing a magnetic field, wearing          ear plugs to muffle loud knocking and thumping sounds that occur during the scanning          process. He or she can speak with a staff member via an intercom system at all times          during the procedure.      In addition to these procedures, patients may be asked to have a fat cell biopsy. This is     done to determine whether insulin-resistant people have fewer fat cells but more fat per cell     than insulin-sensitive people. For this test, a small piece of fat tissue is surgically     removed, under local anesthetic, from an area of the lower abdomen. With the participant's     consent, genetic testing may be done on the fat tissue sample to look for genes that may link     central obesity to insulin resistance.      Some participants may be asked to be followed for an additional 3 months after completion of     the study for a continued weight loss program. The follow-up includes weekly visits for     weight measurements and a review of food records.   "
191323|NCT00350727|"     This study is being conducted to characterize the safety/tolerability of pazopanib and     lapatinib when administered in combination with enzyme-inducing anticonvulsants in patients     with recurrent Grade III or IV malignant gliomas.   "
197258|NCT00422786|"     The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment     of patients with previously treated (refractory) renal cell carcinoma   "
191165|NCT00341419|"     This study will characterize the gene mutations responsible for pseudoxanthoma elasticum     (PXE) and correlate them with disease manifestations in males and females. PXE is an     inherited disorder that affects the connective tissue in some parts of the body. Calcium and     other minerals are deposited in the connective tissue, causing changes in the skin, eyes,     cardiovascular system and gastrointestinal system. Some effects of PXE can cause serious     medical problems, while others have less impact. Symptoms often appear earlier and are more     severe in females than in males, but there is no way to predict how the disorder will     progress in any given individual.      Candidates for this study are recruited through PXE International, an organization that     provides patient support and supports research on the disease. The organization collects     biological samples and medical information on patients and family members to help further     research on the disease. Families that have samples from the patient, both parents, and at     least one sibling may be eligible for this study. Grandparents and extended family members     may be included in certain instances.      Participants provide a blood sample, a sample of cells scraped from the inside of the cheek     (buccal cells) and a medical history. The samples are analyzed for gene variants and the     findings are correlated with disease signs and symptoms.   "
191166|NCT00341432|"     This study will compare the effectiveness of counseling plus use of a nicotine patch with     counseling alone for helping pregnant women quit smoking. Smoking during pregnancy is the     most preventable cause of fetal and newborn health problems such as low birth weight, fetal     growth retardation, sudden infant death syndrome, spontaneous abortion, decreased lung     function and premature delivery.      African-American and Hispanic women 18 years of age or older, smoke cigarettes, and live in     the District of Columbia metropolitan area may be eligible for this study. Candidates are     recruited from the George Washington University and Providence Hospital prenatal health     clinics. They are screened with a review of their medical records and a survey that includes     questions about their age, residency, race and ethnicity, educational level and employment     status, number of weeks pregnant, and exposure to cigarette smoke and other types of tobacco.      Participants answer questions about their smoking behavior, then receive a 10-minute     counseling session and watch a videotape about quitting smoking. Women who are not able to     quit smoking in 1 week are then randomly assigned to one of two treatment groups. One group     continues to receive counseling sessions during the remainder of their pregnancy; the second     group receives nicotine patches as well as the counseling sessions. In addition, all     participants watch a video about smoking and receive a guide to help them quit. Women who     receive the patches must stop smoking completely. If they cannot stop immediately, their     participation in the study ends. The behavioral counseling sessions for all the women are a     series of conversations between the women and a trained counselor to help the woman through     the process of quitting.      Participants are followed during the study with six clinic visits and three telephone calls.     During the first visit, the women answer a series of questions about their smoking habits and     health concerns. A portion of the urine sample they provide during their routine prenatal     visit is used by this study to assess their cotinine (a breakdown product of nicotine)     levels. Saliva and breath samples to test for cotinine and carbon monoxide levels are     collected at each visit. Saliva is collected by brushing the inside of the cheek with a     cotton swab, and breath samples are collected by having the woman blow into a tube connected     to a machine. Participants are evaluated four times during the study with questions about     their smoking behavior.      With the women's permission, their medical records, health, and treatments during pregnancy     are reviewed. At the end of the pregnancy, the infant's weight and health are also reviewed.   "
191167|NCT00341445|"     The most important risk factor for asthma in inner-city homes may be exposure to cockroach     allergen. In a previous study, the researchers reported that extermination alone, without     resident education or professional cleaning, reduced allergen levels in inner-city homes.     This result contradicted earlier findings by other scientists. This study seeks to confirm     the researchers' earlier results, and to determine how intensive an effective extermination     must be.      The study will last one year and include 60 infested, multi-unit rental homes in North     Carolina, divided into three groups. In the Treatment-1 group, researchers from North     Carolina State University will set insecticide bait in initial and follow-up visits, as the     highest standard for treatment. In the Treatment-2 group, one of five commercial pest-control     companies will be randomly assigned to treat each home according to a 12-month, pre-paid     contract. The third group will be a control group that receives no extermination treatment.     In all homes, researchers will periodically survey the residents, monitor cockroach numbers,     and monitor allergen levels in dust samples. If this study is successful, it will be used to     plan future asthma prevention trials.   "
191168|NCT00341458|"     The Polish breast, ovarian and endometrial cancer study is a complex molecular epidemiologic     study that is expected to enroll about 2,500 breast cancer, 450 ovarian and 450 endometrial     cancer cases and 2,500 controls from Warsaw and Lodz, two major cities in Poland. This large     population-based study combines state-of-the-art techniques of exposure assessment and     collection of biological specimens to allow for the study of a wide range of biomarkers.     Exposure information is obtained through detailed personal interviews, anthropometric     measurements, physical activity monitors, and collection of dust samples from the     participants homes. The collection of biological specimens includes blood samples processed     as cryopreserved whole blood, serum+ blood clot, plasma+buffy coat+red blood cells; 12-hour     overnight urine; paraffin embedded tumor and normal tissue; and fresh tissue from tumors,     non-neoplastic breast tissue and mammary fat tissue. Subject enrollment started in June 2000     and is expected to continue until January 2003 for breast cancer cases and controls and June     2003 for ovarian and endometrial cancer cases. As of May 2002, we have identified 2,207     breast, 138 ovarian and 235 endometrial cancer cases and 2,327 controls. The response rates     to the interview are 81% for breast, 90% for ovarian and 83% for endometrial cancer cases and     70% for controls. Most women who agree to the interview agree to provide biological specimens     (about 90% of cancer cases and controls agree to provide a blood sample), anthropometric     measurements (95% of breast cancer cases and controls) and wear a physical activity monitor     (79% breast cancer cases and 90% of controls).   "
191173|NCT00341523|"     Esophageal cancer is a common malignancy with a very poor prognosis. The principal reason for     its poor prognosis is that most tumors are asymptomatic and go undetected until they have     spread beyond the esophageal wall and are unresectable. Significant reduction in esophageal     cancer mortality will require successful strategies to diagnose and treat more cases at     earlier, more curable stages of disease. A successful early detection program will require an     accurate, patient-acceptable screening test, confirmatory tests that can localize precursor     and early invasive lesions, and one or more curative therapies that are acceptable to     asymptomatic patients. This project includes five studies designed to evaluate techniques     that may be useful in such an early detection program:        1. The Cytology Sampling Study will estimate and compare the sensitivity of several          cytologic samplers for identifying biopsy-proven dysplasia and cancer of the esophagus.        2. The Mucosal Staining Study will evaluate whether mucosal straining can improve          endoscopic localization of esophageal dysplasia and cancer.        3. The Endoscopic Staging Study will evaluate how accurately endoscopic techniques can          stage dysplasia and early invasive cancer of the esophagus.        4. The Endoscopic Therapy Pilot Study will evaluate the feasibility, safety, acceptability          and preliminary efficacy of endoscopic therapies for removing or ablating focal          high-grade dysplasias and early invasive cancers of the esphagus.        5. The Chemoregression Study will evaluate the ability of oral chemopreventive agents to          reduce progression or cause regression of low-grade squamous dysplasia of the esophagus.      This project will be carried out in Linxian, China, a county with extraordinary rates of     esophageal cancer and a correspondingly high prevalence of the asymptomatic precursor and     early invasive lesions that are needed for these studies. The project will be a collaborative     effort of investigators from NCI, the Cancer Institute of the Chinese Academy of Medical     Sciences, and several U.S. universities.   "
191169|NCT00341471|"     The Building Futures for Youth (BFY) project is a pilot intervention program for 6th grade     students and their parents in the District of Columbia public school system. The full     intervention will include students in the 6th, 7th and 8th grades. The primary overall goal     of the project is to help students learn to make healthy life choices and delay sexual     initiation.      Sixth-grade children and parents in four Washington, D.C., public schools will be recruited     for this study. Children from two schools will participate in the BFY intervention program     and children from two other schools will serve as controls. Participants are guided through     three study phases, with each phase spanning one school year, as follows:      Sixth-grade students are given a foundation in goal setting, decision-making and     communication skills. They gain knowledge about puberty, reproduction, and the negative     consequences associated with having a child at a young age. They learn strategies for getting     out of situations in which they feel pressured to engage in sexual activity. Through lessons,     activities, and discussions they are given tools to answer the following questions:        -  Who am I? Students engage in self-reflection activities and discussions that allow them          to become aware of their values, beliefs and strengths, increasing self-esteem and a          positive self-image.        -  What do I want for my life? Students engage in goal-setting activities, creating          short-term and long-term goals and mapping out the necessary steps to achieve the goals.        -  How do I get there? Students are instructed in decision-making, problem-solving and          communication skills.        -  How can having sex too early affect my life and the goals I want to achieve? Students          explore the negative impact that engaging in sexual activity too early and getting          pregnant or getting someone pregnant can have on their emotional, social and financial          lives.      Seventh grade students are given the tools and skills necessary to deal with a variety of     challenges they may experience during their developmental years. They receive comprehensive     sex education, in conjunction with life skills such as relationship negotiation, dating     skills, violence prevention and problem-solving skills.      Eighth grade students are guided through a series of activities that encourage students to     translate knowledge gained in the 6th and 7th grade phases into long-term behavioral changes     and risk reduction. Activities include writing and performing skills, creating an     informational pamphlet, designing T-shirts and creating poetry that affirms the BFY message.      In addition, students participate in a program of community service projects, such as the     Anacostia River clean-up coordinated by the Earth Conservation Corps and Martin Luther King     Day events coordinated by Howard University's Community Association and Project Change.      Parents are provided skills training and information on a variety of issues relating to     adolescent sexuality, parental monitoring and parent-child communication.   "
191170|NCT00341484|"     An NCI goal is to identify every human gene that predisposes people to cancer. Recent studies     of HIV-1 indicate that genetic polymorphisms can affect susceptibility to viral infections     and that such alleles may be racially restricted, a range of racial and ethnic groups should     be included in such studies. We propose to examine genetic determinants of infection with     hepatitis B virus (HBV) and hepatitis C virus (HCV) in an ethnically diverse population of     injection drug users (IDUs). HBV and HCV are important causes of hepatocellular carcinoma,     but little is known about genetic factors that alter susceptibility to these infections.     Subjects will be recruited in diverse inner-city neighborhoods as part of the University of     California, San Francisco's Urban Health Study. Since 1986, this study has successfully     recruited and evaluated IDUs from street-based settings. About half of the participants are     African-American, one-third are white, 10% are Latino, and the remainder are Asian or Native     American. The mean duration of drug use exceeds 20 years. About 80% of subjects have evidence     of HBV infection and a similar prevalence of HCV infections is anticipated. We will enroll     about 1500 subjects over a 13 month period. Archived, unlinked serum specimens may be     obtained from previous enrollees to increase the sample size, as needed. Highly     exposed-uninfected subjects will be ascertained on the basis of the serologic testing for     each virus, as well as the duration and frequency of injection drug use. These highly     exposed-uninfected subjects will be compared to infected subjects with regard to their     frequency of genetic polymorphisms (chemokines, chemokine receptors, human leukocyte     antigens, and others), in collaboration with scientists from NCI's Laboratory of Genomic     Diversity.   "
191171|NCT00341497|"     The purpose is to determine the extent of genetic damage in oral mucosal lesions ascertained     in the study, whether specific genotypes are associated with genetic damage observed in the     oral mucosal lesions, whether the extent of genetic damage changes over time, and what     factors (e.g. smoking) contribute to those changes. Genetic damage indicators will include     among others DNA adduct formation, particularly related to tobacco smoke carcinogens such as     polycyclic aromatic hydocarbons. The genotypes of interest will be focused on these affecting     carcinogen metabolism, (e.g., (CYP family), but may also include those related to growth     factors, cell cycle control, and DNA repair. Microsatellite instability is another key     indicator of damage that we plan to examine. This study was undertaken due to the paucity of     data on the types of oral lesions seen in general dental practice and the limited knowledge     of the natural history of these lesions.      Persons were enrolled who had red and/or white oral lesions identified at 6 Dental Clinics at     VA Medical Centers. The VA Centers involved were: Washington, DC; Atlanta, GA; Durham, NC;     San Francisco, CA; Danville, IL; and San Antonio, TX.      When a dentist found a red or white lesions in the course of routine outpatient examinations     and care, obvious causes such as denture frictional lesions could be ruled out, and the     normal standard of care for the lesion was biopsy, the patient was considered for enrollment     into the study. The study was described to the patient, the consent for was signed, the     patient received an intraoral examination to identify and characterize the oral lesions, the     lesions were photographed, an oral epithelial cell sample was taken from the site and from     the rest of the oral mucosa, and the patient was interviewed using a standard questionnaire     that requested information about sociodemograhic, medical, and lifestyle factors,     particularly tobacco and alcohol use all as part of the study protocol, and the patient     received a biopsy as part of normal care. The biopsy report was obtained as was a small piece     of the biopsy material that was not needed for patient diagnostic purposes. The subjects     returned every 4-6 months for reassessment of the lesion or to determine that the lesion had     not returned. The patients completed a questionnaire at each of these visits so that     lifestyle factors such as tobacco and alcohol use could be reassessed. Also oral epithelial     cell scrapings were obtained at each of these visits.      This study is particularly valuable because longitudinal data was collected and because the     data were collected over time using standard procedures.   "
191172|NCT00341510|"     This study is a survey (Health Behaviors in School-age Children) sponsored by the World     Health Organization to gather information about nutrition, dieting practices, physical     activity, injuries, violence, relationships with family and friends, perceptions of school as     a supportive environment, alcohol and tobacco use and drug use among adolescents, and about     the communities in which students live. The U.S. sponsors of the survey are the National     Institutes of Health and the Health Resources and Services Administration.      The objectives of the international HBSC study are:        -  To assess the prevalence of early adolescent health behaviors        -  To identify psychosocial factors associated with adolescent behaviors        -  To provide an opportunity for analyses of cross-national comparisons        -  To provide an opportunity for analyses of trends in the U.S. and cross-nationally      In addition to the above, the survey includes additional questions designed to provide     information about areas of specific national interest, including the following:        -  To assess the association of school, family, peers, and other environmental factors on          health behavior and health status        -  To assess the prevalence and identify factors associated with diet and physical activity        -  To assess the prevalence and identify factors associated with bullying and risk          behaviors.      This is the third U.S. administration of the HBSC survey, previously administered in     1997-1998 and 2001-2002.      U.S. participants in the survey include about 15,000 students from 350 schools selected to     take part across the country. In each school, one or two classes (about 25 students) in each     grade 6 through 10 are picked randomly to participate. In one class period, the students     complete the written survey, which has 80 multiple choice questions. Students do not put     their name on the survey. When they finish the survey, the place it in an envelope and seal     it shut. The envelopes are then put in a box. Reports will not include the names of     participating counties, cities, school districts, schools, or students.      The information collected from U.S. school children is compared with similar information     collected from school children in 36 other countries. The survey is used to help set national     priorities for school and youth programs, as well as to monitor the progress of these     programs.   "
191174|NCT00348153|"     TNF alpha Inhibitors have been very effective in treating rheumatologic diseases as well as     uveitis. Adalimumab is the first member of a new class of TNF antibody compounds developed to     contain exclusively human sequences. We want to test the efficacy and safety of the TNF alpha     Inhibitor Adalimumab in patients with active uveitis despite standard immunosuppressive     therapy.   "
191175|NCT00348166|"     The purpose of this study is to find out if undercorrection of myopia slow down the     progression of myopia in kindergarten children.   "
191182|NCT00348257|"     Removal of unwanted hair is one of the most commonly sought cosmetic solutions. Traditional     methods, such as shaving, depilatories, tweezing and waxing result in only temporary hair     removal, and thus require extensive maintenance. Long term hair removal via electrolysis is     generally unsatisfactory due to its time consuming, painful nature and the associated risk of     scarring or pigmentary changes. Moreover, the efficacy of electrolysis is user dependent and     is estimated to be reduction of only 15-50% of the unwanted hair3.      The more modern approach to long term hair removal involves laser and Intense Pulsed Light     (IPL) treatment modalities. These technologies are based on the scientific principle of     selective photothermolysis. During the treatment, the light energy is absorbed by the hair’s     pigment (melanin) and transmitted through the hair shaft to the follicle. Conversion of this     energy into heat causes a rise in the hair temperature, leading to destruction of the     follicle and disruption of the hair growth mechanism, while leaving the skin undamaged.      Both laser and light devices have been proven successful in inducing permanent hair removal,     as well as delayed hair growth, while causing minimal discomfort and complications. The light     devices are based on the IPL technology, which differs from laser light in various physical     aspects. The main difference is that while lasers emit light at a distinct wavelength, IPL     delivers a wide range of wavelengths (400 1400 nm), thus allowing greater flexibility in     aspects of body area, hair color and skin type LEORTEC LTD. has developed an innovative     device that integrates the two treatment modalities: Laser and Intense Pulse Light (IPL) and     in addition MLS - Multi Light Source- a combination of the two modalities. The purpose of     this study is to evaluate the safety and efficacy of using Leortec 300 device for hair     removal treatment.   "
191183|NCT00348270|"     This study is a comparison of the quality of vision provided by AMO Tecnis Z9000 three-piece     silicone posterior chamber intraocular lens and Alcon Laboratories MA60 three-piece acrylic     posterior chamber intraocular lens.   "
191184|NCT00348283|"     The goal of this study was to test whether adalimumab can induce mucosal healing in subjects     with moderate to severe ileocolonic Crohn's Disease.   "
191185|NCT00348296|"     This randomized, double-blind, placebo-controlled multi-center study will carry out to assess     the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in     modified Rodnan total skin thickness score (TSS) as primary endopoint, and in addition, to     assess the safety of GB-0998.   "
191186|NCT00348309|"     Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a     treatment for type II diabetes mellitus, a disease that occurs when the body is unable to     effectively use glucose. RSG XR, the investigational drug used in this study, is an     extended-release form of RSG.      This study tests whether RSG XR safely provides clinical benefit to people with mild to     moderate Alzheimer's disease (AD) when combined with the currently approved AD medication,     Aricept (donepezil). RSG XR is a new approach to AD therapy and this study tests a new way to     treat AD by testing whether one's genetic makeup affects their response to the study drug.     Clinical data suggesting that RSG may benefit AD patients was first seen in a small study     performed at the University of Washington and then from a larger GSK study conducted in     Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months     scored significantly better on 3 tests of memory and thought than those who did not receive     RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a     specific genetic pattern. They did not have the gene that caused them to produce the protein     apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one     from each parent, or they may have only one APOE e4 gene meaning that they inherited either     the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents.     Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability     while those with two copies of the APOE e4 gene, continued to worsen during the 6-month     treatment. The current study will more directly test the effectiveness or RSG XR on people     who either have or lack the APOE e4 gene.   "
191187|NCT00348322|"     The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783     in comparison to Refresh Tears Lubricant Eye Drops (Allergan) in a specified population of     dry eye patients.   "
191188|NCT00348335|"     The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective     in the treatment of ocular rosacea   "
191189|NCT00348348|"     This is a study to investigate a novel drug candidate for the treatment of bacterial     conjunctivitis.   "
191190|NCT00348361|"     This study is aimed at validating key therapeutic targets and biomarkers associated with     allergic rhinitis. The therapeutic target expression will be investigated after a 7 day     course of corticosteroid treatment followed by allergen challenge.   "
191191|NCT00348374|"     The current trial will examine the efficacy and safety of Exubera administered as a mealtime     insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or     = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion     of subjects to reach target glycosylated hemoglobin (A1C) levels.   "
191192|NCT00348387|"     This study is intended to support the registration of IMOVAX Polio in China.      The primary objective of this Pase III trial is to compare IMOVAX Polio to the current     Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The     objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection     rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV     dose.   "
191193|NCT00348400|"     Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as     adjunctive therapy   "
191194|NCT00348413|"     This project will compare the efficacy and safety of 2 methods of disease modification in the     treatment of active moderate and severe thyroid orbitopathy. A prospective, randomized,     double-blind, parallel, controlled multidisciplinary clinical trial involving Singapore     National Eye Centre, National University Hospital, Changi General Hospital, Tan Tock Seng     Hospital and University of British Columbia Orbital Services, Singapore Eye Research     Institute, Singapore General Hospital Endocrinology and Radiology Departments and Tan Tock     Seng Hospital Rheumatology Department is planned. The SingHealth-SGH High Field MR Research     Laboratory will be involved in the MR imaging of the trial patients.      Patients who satisfy the inclusion and exclusion criteria will be asked to participate in     this trial. After informed consent (Appendix B) is obtained, each patient will be randomized     into one of two treatment arms: 1) Intravenous high-dose pulsed methylprednisolone (1 gram     infusion over 1 hour per day with a total of 3 doses over 3 days; 4 cycles at 6 weekly     intervals) and oral placebo and 2) Intravenous high-dose pulsed methylprednisolone (same     dose) plus oral methotrexate 7.5 mg per week for 2 weeks, increased to 10 mg per week for     another 2 weeks then 12.5 mg per week for 5 months (total 6 months of methotrexate     treatment). Depending on patient response, the dose can be further increased by 2.5mg per     week every 4 weeks to a maximum of 20 mg per week. A strict management protocol will be     observed for each recruited patient. Patients who develop adverse side effects or need for     surgical intervention will receive appropriate treatment (i.e. treatment will deviate from     the protocol but will continue to be monitored). Patients who refuse treatment will be     observed clinically and with imaging as a natural control group until such time as     intervention is accepted.      The patients will have a baseline assessment followed by regular visits to assess treatment     response and adverse effects. Observations will include the use of an inflammatory index,     motility measurements including quantitative ductions, exophthalmometry readings, palpebral     aperture readings and indices of optic nerve function. With regards to the imaging, the     patients will be assessed with an initial quantitative CT scan and 3-Tesla MRI scan prior to     treatment. After treatment is started, patients will also undergo repeat MRI scan at 24 weeks     and 72 weeks to assess quantitative changes with treatment using the Muscle Diameter Index     (MDI) and Pixel Value Ratio (PVR) for the inferior rectus, superior rectus, the medial     rectus, lateral rectus and orbital fat (Appendix E). Serum and urine will be obtained at the     same time intervals as the MRI scan to assess levels of thyroid hormones, thyroid antibodies     and urinary glycosaminoglycans (GAGs). Free T4, free T3 and TSH will be recorded to monitor     control of hyperthyroidism. Thyroid antibodies measured will include thyroid stimulating     immunoglobulin (TSI), thyrotropin-binding inhibition antibody (TB II), thyroid peroxidase     antibodies and thyroglobulin antibody. Other tests including the full blood count, urea and     electrolytes will be run prior to each dose of steroid treatment and during follow-up to     monitor for adverse effects.      The results of the assessments will be analyzed for significant differences in treatment     response between the 2 groups. The indices of interest will include the percentage of     patients in each group who demonstrate a decrease in the inflammatory index of at least 2     points and the time taken for 50% of patients to show such a decrease. Other parameters that     reflect the visual function and motility will be compared at different points in time after     starting treatment to observe response and sustainability of response. From the serial MRI     scans, quantitative analysis of orbital tissues will be done to identify changes with     treatment. Antibody and GAG levels will be analyzed to detect any change with treatment. The     types and frequency of adverse side effects in the 2 groups will also be assessed.      80 normal subjects will be recruited for MRI scan of the orbits and brain to obtain normative     values for the MDI and PVR for the Asian population (Appendix E). This will include 20     subjects from each of 4 decades (21-30 years, 31-40 years, 41-50 years, 51-60 years).      The normative data will also be used to create a virtual orbital atlas. This aspect of the     study will be performed in collaboration with the Labs for Information Technology (A-Star).   "
191195|NCT00348426|"     A second botulism outbreak in Northern Thailand was reported in 2006. 192 people were exposed     to raw meat and the gut of deer, 83 suffered from diarrhea. Of these 5 developed respiratory     failure, 1 impending respiratory failure.      We analysed the clinical findings and electrophysiologic findings in this second episode of     large botulism outbreak in northern Thailand.   "
191196|NCT00348439|"     Plasmin is expected to create a posterior vitreous detachment. The pharmacological creation     of a posterior vitreous detachment may be beneficial in a variety of conditions.   "
191197|NCT00348452|"     The purpose of this study is to compare the analgesic efficacy and safety of tramadol HCl ER     100 mg, 200 mg and 300 mg once a day (QD), with placebo in patients with moderate to severe     pain due to OA. For the purposes of this study, celecoxib will serve as a positive control to     validate the sensitivity of the model. The study hypothesis is that tramadol HCl ER is safe     and effective in the treatment of moderate to severe pain due to OA.   "
191198|NCT00348465|"     The size of the prostate changes due to insertion of the radioactive seeds. We will measure     the prostate size, before and after the procedure.   "
191213|NCT00349245|"     The objective of this study is to determine the efficacy and safety of Dexmedetomidine, a     selective alpha-2 adrenoceptor agonist, which has recently gained increased popularity for     ICU and intraoperative sedation as a sedative during awake fiberoptic intubation, as compared     to Remifentanil.      The hypothesis is that Dexmedetomidine will provide at least equal if not better conditions     (sedation and analgesia) required for awake fiberoptic intubation (Ramsay Sedation Scale 3)     with less respiratory and cardiovascular adverse effects, as well as less recall than     Remifentanil.   "
191219|NCT00349323|"     The WHO Special Programme for Research and Training in Tropical Diseases (TDR) developed a     Community-Directed Treatment (COMDT) approach, which has been adopted in the control of     onchocerciasis and lymphatic filariasis. WHO has recommended the use of COMDT approach in the     control of schistosomiasis and STH infections. The COMDT approach has been compared with the     school based programmes in certain African countries,but not with the health-facility based     approach.      The project will be implemented in Mazabuka district of Zambia where COMDT approach will be     implemented in the catchment area of Rural Health Centres (RHC) as a supplement to the     health-facility-based approach. After each round of treatmenttreatment coverage and factors     responsible for the treatment coverage will be measured in both areas. The health impact of     the health facility based approach with and without the COMDT approach will be compared. The     effect of the COMDT as a control approach of STH infections will be monitored on infections     in the community of children aged 12 to 59 months.   "
191220|NCT00349336|"     This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state     under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or     FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm     will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the     FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated     time on study treatment is 3-12 months, and the target sample size is <100 individuals.   "
191221|NCT00349349|"     The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the     treatment of patients failing both fludarabine and alemtuzumab.   "
191222|NCT00349362|"     The purpose of this study is to test the effect of testosterone treatment on glycaemic     control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with     insulin.   "
191223|NCT00349375|"     Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both     hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary     mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall     objective of the study is to evaluate the efficacy and safety of combining fenofibrate and     simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.   "
191224|NCT00349388|"     To determine whether once a day administration of Mesalamine is at least as safe and     efficacious and administration of multiple doses a day in preventing clinical relapse of     ulcerative colitis in children and adolescence.   "
191225|NCT00349401|"     The purpose of this study is to determine how the drug ketorolac, when given with the spinal     morphine, affects pain.   "
191226|NCT00349414|"     The aim of this study is to compare the safety and efficacy of conventional and micropulse     transscleral diode laser in the treatment of end-stage glaucoma.   "
191227|NCT00349427|"     This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type     2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone     is efficacious in terms of improving glycemic control.   "
191228|NCT00349440|"     The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic     solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients     undergoing LASIK or photorefractive keratectomy (PRK).   "
191229|NCT00349453|"     Systematical (retro- and prospective) investigation of the long-term safety (toxicity     assessment according to CTCAE v3.0) and efficacy of deferiprone either given alone or in     combination with desferrioxamine   "
191230|NCT00349466|"     This is a Phase 2, randomized, double-masked, placebo-controlled, parallel-group study in     adult males and females, aged 18 years and over, with a diagnosis of moderate-to-severe     keratoconjunctivitis sicca (KCS). Patients will be randomized to receive either CF101 1 mg or     matching placebo, given orally every 12 hours (q12h) for 12 weeks. A Screening Period of up     to 4 weeks that includes a 2-week run-in period will precede a 12-week treatment period,     followed by a 2-week follow-up period.   "
191231|NCT00349479|"     The purpose of this study is to evaluate a standardized, system-based, barrier assessment and     interactive educational intervention to increase appropriate t-PA use for stroke.   "
191232|NCT00349492|"     This study is a randomized, multi-center clinical trial. Patients are stratified according to     performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2     treatment arms.      Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses     repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on     day 1. Coursed repeated every 3 weeks      Treatment in both arms continues for 6 courses in the absence of disease progression or     unacceptable toxicity.      Patients are followed every 3 months for 1.5 years   "
191233|NCT00349505|"     Phase II to study results and morbidity of intra peritoneal hyper-thermic chemotherapy as     consolidation therapy in patients with FIGO stage IIIC epithelial ovarian carcinoma treated     by surgery and a total of 6 cycles of platinum based chemotherapy.      A second look operation is performed after treatment; during this second look secondary     cytoreductive surgery is accepted without bowel resection.If none or milimetric peritoneal     disease is obseved an intraperitoneal chemotherapy is achieve   "
191234|NCT00349518|"     The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant     or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic     myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The     efficacy of the drug in this kind of patients will also further be documented.   "
191235|NCT00349531|"     The primary objective of this study is to investigate the effects on RLS symptoms and sleep     disturbance of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks,     compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome   "
191236|NCT00349544|"     The primary purpose of this study is to adapt the Neck Disability Index (NDI)and the Cervical     Core Set 6 (CCS6) to the Spanish population. Other objectives are to determine the     correlation between intensity of cervical pain, degree of disability, and quality of life; to     determine the correlation between the NDI, CCS6 and the Northwick Park Neck Pain     Questionnaire; and to determine factors that predict the chronification of disability.   "
191612|NCT00353067|"     The purpose of this study is to determine if veliflapon (DG-031)can prevent a heart attack or     stroke in African American patients with a history of unstable angina or myocardial     infarction.   "
191238|NCT00349570|"     Intra-coronary thrombosis and thromboembolism continues to be a challenge for percutaneous     coronary and other vascular interventional techniques. The Xtract™ Aspiration Catheter is a     single use device designed to remove fresh, soft emboli and thrombi from the arterial system     using standard catheter techniques, compatible with 6 Fr guide catheters and 0.014     guidewires. The purpose of this registry study is to validate the design and demonstrate the     performance of the Xtract Aspiration Catheter as a thrombectomy catheter during percutaneous     intervention of vessels in the arterial system. Subjects will be enrolled during percutaneous     intervention when the Interventional Physician decides a thrombectomy catheter is needed to     remove thrombus during the procedure.   "
191239|NCT00349583|"     The purpose of this study is to evaluate the efficacy on quality of vision and dry eye signs     and symptoms in patients undergoing cataract surgery using the ReZoom® multifocal IOL.   "
191240|NCT00349596|"     The goal of this clinical research study is to find the safety of decitabine in patients with     acute lymphocytic leukemia. Upon agreement of the patient, additional blood and bone marrow     samples to be used to evaluate the effect of the treatment on leukemic cells. Also, with     agreement of the patient, any leftover blood and bone marrow samples that are collected at     the start of the study and during the regularly scheduled evaluations to be sent for research     studies. The research studies will examine changes in the blood and bone marrow cells that     might help explain the causes of leukemia.   "
191241|NCT00349622|"     The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in     amyotrophic lateral sclerosis (ALS).   "
191242|NCT00349635|"     To investigate the effect on body weight of a combination fenofibrate and metformin on top of     a moderate balanced calorie-deficit diet.   "
191243|NCT00349648|"     Study hypothesis: The impingement syndrome of the rotator cuff is a common cause of shoulder     pain for which the most effective treatment is unknown. Steroid injections and     anti-inflammatory analgetics are considered as effective methods. Physiotherapy and     acromioplasty are commonly used treatments.      Hypothesis: Arthroscopy and acromioplasty in addition to conservative treatment is equally     effective as conservative treatment alone for shoulder impingement syndrome.   "
191244|NCT00349661|"     Objectives: A prospective investigation of the effect of omeprazole, a proton pump inhibitor,     on the anti-platelet action of clopidogrel.      The main decision criterion will concern change in VASP protein phosphorylation under     treatment. Phosphorylation will be measured before and after administration of omeprazole     versus placebo in patients undergoing clopidogrel treatment.      Type of study: Single center, double blind, randomized parallel group study versus placebo,     comparing two treatment groups:        -  clopidogrel + omeprazole + standard regime (beta-blockers, atorvastatin, IEC, aspirin)        -  clopidogrel + placebo+ standard regime (beta-blockers, atorvastatin, IEC, aspirin)      Study population: 120 patients from the Cardiology Department of Brest University hospital,     Brest (France), receiving a standard treatment comprising a loading dose of clopidogrel     followed by a daily dose of 75 mg associated to 75 mg aspirin, will be randomized between 20     mg/day omeprazole and 20 mg/day placebo treatment groups. The efficacy of clopidogrel will be     assessed by inter-group comparison on the VASP test.      Study period: 7 days' treatment per patient. Total study period estimated at 6 months.      Expected findings: The results should confirm the suspected negative effect of omeprazole on     clopidogrel's impact on arterial thrombosis risk, secondarily allowing new recommendations to     be drawn up for this association.   "
191245|NCT00349674|"     Remission of ANCA-associated vasculitis can be obtained in approximately 80% of the patients     with a combination of corticosteroids and cyclophosphamide. However, relapses are frequent.     This point warrants the prescription of a maintenance treatment with a less toxic     immunosuppressant for several months to years. The optimal drug in this indication is not     determine. We decided therefore to compare the 2 most used drugs in this indication.     Induction therapy consists in the combination of corticosteroids and intravenous     cyclophosphamide pulses. Corticotherapy consisted first in one daily methylprednisolone     pulse, for 1 to 3 days, followed by oral prednisolone at the dose of 1 mg/kg/d for 3 weeks,     then progressively tapered and stopped at the 18th month from the diagnosis. Cyclophosphamide     is administered every 2 weeks for the first 3 bolus (0.6 g/m2 - D1, 15 and 30), then every 3     weeks (0.7 g/m2). Once remission is achieved, patients receive 3 additional bolus (0.7 g/m2).     At that time, patients are randomized for a maintenance treatment with azathioprine (2     mg/kg/d, orally) or oral methotrexate (starting at the dose of 0.3 mg/kg/wk, then     progressively increased every weeks by 2.5mg, if necessary, to a maximum and optimal dose of     25 mg/wk) for 12 months.   "
191246|NCT00349687|"     The proposed study will investigate the role of self-control in smoking cessation and whether     interventions that improve self-control can help reduce the risk of lapsing among smokers who     wish to quit. Our model predicts that the regular practice of self-control should lead to a     building of strength and a general improvement in self-control performance. Hence, smokers     who practice self-control prior to quitting should be more likely to succeed in their     cessation attempt than smokers who do not practice self-control   "
191247|NCT00349700|"     The purpose of the study was to investigated if modern wound dressings adapting to wound     exudation and the amount of bacterial colonization can heal large therapy resistant leg     ulcers which had a pre-treatment with compresses, ointments and gauze   "
191265|NCT00349934|"     Open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory     setting in patients receiving as a first line chemotherapy for metastatic breast carcinoma     the standard 6 cycles of weekly paclitaxel (80 mg/m² at D1, D8 and D15 of a 4-week cycle).     Three IMP321 doses (0.25, 1.25 and 6.25 mg) will be tested and given at D2 and D16 of this     4-week cycle, for 6 courses.   "
191248|NCT00349713|"     Malaria is a disease that affects many people in Africa and in Mali. It is caused by germs     that are spread by mosquito bites. This study will look at the safety, effectiveness, and     best dose of an experimental malaria vaccine in people who are regularly exposed to malaria.     Study participants will be 60 adults, 18-55 years old, who live in Bandiagara, Mali.     Volunteers will get either 3 full doses of the experimental malaria vaccine, 3 half doses of     the malaria vaccine, or a rabies vaccine that has been approved in Mali. (Rabies is an     infection of the brain that usually causes death, and can be caught from being bitten by     infected dogs or bats.) The 3 vaccinations will be given by injection into the upper arm 30     days apart. Volunteers will be enrolled in the study for approximately 12 months after the     first vaccination. Volunteers will have 14 blood samples collected during the study for     testing to make sure that the vaccine is not harmful and to measure the effect of the     vaccine.   "
191638|NCT00353431|"     The aim of this study is to test the safety and efficacy of a new algorithm for intensive     s.c. insulin injection in medical emergency patients with hyperglycaemia (plasma glucose     concentration ≥ 8 mmol/l)   "
191249|NCT00349726|"     This pilot study was a randomized, placebo-controlled, clinical trial to measure changes in     blood and urine levels of inositol in premature infants at high risk for retinopathy of     prematurity (ROP) following a single intravenous dose of inositol. Based on previous studies,     the premise is that maintaining inositol concentrations similar to those occurring naturally     in utero will reduce the rates of ROP and bronchopulmonary dysplasia in premature infants.     The objective was to evaluate the single-dose pharmacokinetics and safety of different     amounts of intravenous myo-inositol (provided by Ross Products Division, Abbott Laboratories)     in very low birth weight neonates, in preparation for a future Phase III multi-center     randomized controlled trial. This study enrolled 74 infants at high risk for retinopathy at 9     NICHD Neonatal Research Network sites, and randomly assigned them to receive either 60mg/kg     of 5% inositol, 120 mg/kg of 5% inositol, 60 mg/kg of 5% glucose (the placebo), or 120 mg/kg     of 5% glucose.   "
191250|NCT00349739|"     The purpose of this study is to evaluate whether anecortave acetate can slow or stop the     progression of age-related macular degeneration in patients who do not qualify for other     studies and have no other treatment options.   "
191251|NCT00349752|"     The current study is designed to measure the corticosteroid-sparing effect of certolizumab     pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe     Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at     a dose no higher than 30 mg/day prednisone or equivalent during the week prior to     randomization.   "
191252|NCT00349765|"     The purpose of this study is to determine whether snacks differing in fat amount and type     result in changes in cardiovascular disease risk factors in men and women who have mildly     elevated cholesterol levels. Our hypothesis is that a diet containing snacks rich in     polyunsaturated fats lead to a more favorable cardiovascular disease risk profile than a diet     containing snacks rich in saturated and trans fats or one containing low-fat snacks.   "
191253|NCT00349778|"     This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to     treat multiple myeloma. The study is being performed to evaluate the efficacy and side     effects of treatment. Specifically, the study is designed to reduce the risk of interstitial     pneumonitis.   "
191254|NCT00349791|"     This study is designed to evaluate efficacy and safety of a testosterone patch as treatment     for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin     therapy.   "
191255|NCT00349804|"     The purpose of this study is to test if temperature homeostasis in football players can be     improved by circulating cool, dry air underneath shoulder pads between periods of intense     physical activity.   "
191256|NCT00349817|"     This study examines the best way to teach genetics to family medicine residents. First year     family medicine residents at the University of Toronto will be taught basic clinical genetics     as well as a specific disease in genetics via 3 different educational methods. All     participants will undergo an oral examination and written knowledge test 3 months after this     education. Results between groups will be compared, and the best way to teach genetics to     residents determined.   "
191257|NCT00349830|"     The purpose of this study is to measure the levels of serum proteins and other biomarkers in     cancer patients and in patients suspected of having cancer. We believe that some of these     markers may be useful for confirming the diagnosis or for selecting patients for specific     types of cancer therapies. These markers may also help to predict response to therapy,     relapse after therapy, and survival after therapy.   "
191258|NCT00349843|"     The primary objective of this study is to compare subjective ocular symptoms and corneal     staining over time in a group of individuals who wear soft contact lenses on a daily wear     basis, whilst they sequentially use two different contact lens care regimens.   "
191259|NCT00349856|"     The purpose of the study is to evaluate the fit and performance of an investigational soft     contact lens in comparison with a currently marketed lens. Both lenses will be worn on a     continuous wear basis, which means the lenses will be worn while sleeping.   "
191260|NCT00349869|"     The purpose of this study is to evaluate the impact of yoga on inflammatory arthritis and     knee osteoarthritis.   "
191261|NCT00349882|"     The purpose of this study is to compare the performance of two different contact lens care     solutions, specifically their affects on the front surface of the eye.   "
191262|NCT00349895|"     This is a multi-center, prospective, non-randomized study. Approximately 90 patients from up     to 16 centers will be entered in the study. Patients will be followed clinically for up to 5     years post-procedure. All patients will have a repeat angiography at 6 months follow-up.      The primary objective of this study is to evaluate the safety and effectiveness of the Genous     Bio-engineered R stentTM in conjunction with optimal statin therapy (80mg of atorvastatin),     in the treatment of elective patients with up to two de novo native coronary artery lesions.     The Genous stent received CE mark for the intended indication in August 2005   "
191263|NCT00349908|"     Feasibility study to assess safety of treating patients with self expanding stent in     intracranial arteries.   "
191264|NCT00349921|"     The purpose of this study is to determine the effects of clonidine and adenosine on nerve     pain.   "
191266|NCT00349947|"     An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta,     which is a large blood vessel in the abdomen. If an AAA ruptures, it can be life-threatening.     Research has shown that sedentary individuals are at increased risk of developing AAAs. This     study will evaluate the effectiveness of an exercise program at limiting the growth of small     AAAs in older individuals.   "
191319|NCT00350675|"     In this ecological study we examine the impact of stress from repeated terrorist attacks     during the second initifada on medical utilization by the Israeli population. We hypothesize     that in weeks following serious terror attacks there will be an increase in prescriptions for     psychiatric medications and an increased number of unexplained somatic complaints. We will     also examine associations with overall medical utlization. We will consider age, gender and     effects of geographic poximity to location of attacks.   "
191267|NCT00349960|"     Currently, less frequent than once weekly subcutaneous epoetin administration regimens were     shown to be equally effective and safe as the once-weekly schedules in stable pre-dialyzed     and peritoneal dialyzed patients Bioequivalence of once-every-two-weeks and once-weekly     subcutaneous administration of the same total dose of epoetin beta for the maintenance phase     of anemia treatment in stable, iron-replete, chronic hemodialyzed patients was therefore     prospectively investigated.      two treatment schedules will be considered equivalent if the primary efficacy parameters will     be simultaneously similar for both groups and in the predefined range of variation.     Confidence intervals (CIs) will be used to compare groups. Since the target Hb in dialyzed     patients is defined as 11g/dL (110 g/L) by the European Guidelines and as >10 g/dL (100 g/L)     by the National Guidelines, with a recommended upper limit of 13 g/dL (130 g/L), the efficacy     range for Hb in this study was predefined as 10-12 g/dL (100-120 g/L). The two treatment     schedules will be considered to have similar efficacy if the mean Hb in Group 2w will not     differ by more than ±0.5 g/dL (±5 g/L) compared to Group 1w during the assessment period.     Once similar efficacy established, drug requirements will be compared calculating the ratio     of the mean weekly epoetin doses in Group 2w/Group 1w. A range of 0.8 to 1.25 for the ratio     is considered sufficient to define bioequivalence. Equivalence of drug usage in the two arms     will be accepted if the whole 95% CI for this ratio will be within the above limits.      Lack of difference between group means does not imply similar distribution of treatment     effects within each group. The individual hemoglobin change will be used to assess if     response to treatment was similarly variable in the two arms. The change in Hb will be     calculated for each patient as the difference between the mean Hb during the assessment     period and the mean Hb during the baseline phase.   "
191268|NCT00349973|"     This is a 6-week, randomized, double blind, parallel groups designed, olanzapine-controlled     trial of oral dipyridamole in symptomatic patients with a (DSM IV) diagnosis of     schizophrenia, schizoaffective or schizophreniform disorder. This pilot study aims to provide     preliminary estimates of whether the effect sizes of dipyridamole on positive symptoms,     negative symptoms, and cognitive deficits differ between schizophrenia patients treated with     dipyridamole, and schizophrenia patients treated with olanzapine. A total of 30 subjects will     be recruited locally.   "
191269|NCT00349986|"     The rationale of the study is to determine:        -  the first dose and the titration of basal insulin        -  the exact daily time administration of basal insulin in poorly controlled type II          diabetic patients.   "
191270|NCT00349999|"     The purpose of this study is to better understand how the body fights and protects against     cholera. Two hundered fifty people presenting to the International Centre for Diarrhoeal     Diseases Research, Bangladesh, admitted with acute cholera, 50 of whom (healthy, nonpregnant,     18-45 year olds) will be enrolled in this substudy of mucosal immunity involving duodenal     biopsy. The remainder of the study is observational, involving collection of stool, vomit,     and blood samples only. The biopsy requires a flexible tube with a camera be inserted through     the mouth into the stomach and intestine. During this procedure, small samples will be     collected from the intestine. The study includes medical history, physical, blood testing,     hospitalization and urine pregnancy testing. This study will last for 5 years and patients     will participate for 3 years.   "
191271|NCT00350012|"     The purpose of this research study is to learn how people distribute their visual attention     when looking at objects nearby versus far away, and why vision may become distracted at near     versus far distances.   "
191272|NCT00350025|"     The purpose of this research study is to determine whether the investigational drug     cetuximab, (Erbitux) alone or with paclitaxel (Taxol) can stabilize the growth of urothelial     cancer.   "
191273|NCT00350038|"     The rationale of the study is to clarify whether the supplementation of irbesartan with     ciprofibrate could increase the antihypertensive effect, could improve the endothelial     functions, and/or could affect the atherogenic small-dense LDL-, oxydized LDL concentrations,     onto the paraoxinase activity and on the CRP and insulin levels.   "
191274|NCT00350051|"     The purpose of this study is to evaluate whether treatment with a new drug called     ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate     cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA     (Prostate-specific antigen) levels.   "
191275|NCT00350064|"     The purpose of this study is to determine if sixteen weeks of high intensity physical     training is more effective than sixteen weeks of low intensity physical training in reducing     abdominal fat and lowering risk factors associated with the metabolic syndrome. Another aim     of this study is to determine if high intensity physical training improves cognitive     function.   "
191276|NCT00350077|"     The purpose of this study is to see if intravenous Vitamin C will decrease the amount of IV     fluids needed following burn injury in the first 48 hours.   "
191277|NCT00350090|"     The purpose of this study is to evaluate the effectiveness and safety of PROCRIT (Epoetin     alfa) administered at 40,000 Units weekly in cancer patients that are not receiving     chemotherapy or radiation therapy.   "
191278|NCT00350103|"     The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in     reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for     lacosamide will be used to further determine the efficacy of the standard scheme and to     evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly     assigned to one of three treatment groups. Subjects in two of the groups will receive     lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to     reach this final dose. The third group of subjects will receive a placebo. Subjects will have     a 2 in 3 (66 %) chance of getting lacosamide.      The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration     will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable     dose of lacosamide or placebo.   "
191279|NCT00350116|"     Objective: To test the efficacy and tolerability of a vitamin B12 cream for the treatment of     chronic plaque psoriasis.      Design: Multicenter, double-blind, randomized, placebo-controlled trial.   "
191881|NCT00358137|"     This study will evaluate the effect of an aerobic training program versus a strength training     program on the autonomic nervous system at rest and in response to challenge.   "
191286|NCT00350207|"     This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy,     placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of     tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients     homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor     (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be     randomised into the 16 week double-blind treatment period in which they receive either     tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily     administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily.     After the 16 week treatment period all patients will receive salmeterol MDI twice daily for     four weeks.      The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume     in the First Second (FEV1) measurements with an electronic peak flow meter throughout the     study. Daily data on asthma control and use of rescue medication are recorded using an     electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma     Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure     and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.   "
191287|NCT00350220|"     The purpose of this study is to determine the best red blood cell(hemoglobin) level for     infants and children following surgical repair of particular heart defects. These children     often receive red blood cell transfusions after surgery, but what the best hemoglobin level     is for them remains unknown.   "
191288|NCT00350233|"     The objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the     treatment of metastatic bone tumors.   "
191289|NCT00350246|"     This study will determine if there are short- and long-term postoperative differences in     visual and corneal outcomes between different laser refractive surgical procedures.   "
191290|NCT00350272|"     Elvucitabine is a novel nucleoside analog that is being studied as a treatment for patients     infected with HIV-1. This Phase II study will enroll 60 HIV-1 naive subjects to assess the     efficacy and safety of elvucitabine compared to lamivudine in combination with tenofovir and     efavirenz measured by changes in the patient's HIV-RNA level and CD4 cell count. The study     treatment will be 12 weeks of blinded study medication followed by an additional 84 weeks of     open label treatment if the patient's response to treatment meets certain endpoints. Also     there will be assessment of the pharmacokinetics of elvucitabine during the study.   "
191291|NCT00350285|"     This behavioral research is an efficacy trial evaluating an intervention called The Teen     Marijuana Check-Up with non-treatment seeking adolescent marijuana users.   "
191292|NCT00350298|"     Patients with Clostridium difficile associated disease who fulfill the eligibility criteria     will be approached to participate. All study patients must receive standard of care treatment     for Clostridium difficile associated disease. Enrolled patients will be randomized to receive     a single intravenous solution of a human monoclonal antibody (huMab) to C. difficile toxin A     (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or     0.9% sodium chloride as placebo in a 1:1 treatment allocation.Patients will be evaluated for     safety and clinical outcomes through day 84 +/- 10 days. Occurrence of adverse events, use of     concomitant medications, and stool output will be assessed at scheduled phone contacts and     study visits. Some patients enrolled will have a subsequent visit on day 168 ± 14 days.   "
191293|NCT00350311|"     This study is a feasibility study of a multi-component intervention to enhance healthy living     among young people with psychotic disorders, specifically targeting smoking and weight.   "
191294|NCT00350337|"     This descriptive study will evaluate the safety and immunogenicity of 3 different     formulations of the WRAIR dengue vaccine compared to a placebo.   "
191295|NCT00350350|"     The primary objective of the trial is to evaluate the efficacy, safety and clinical     acceptability of OGT oromucosal spray in the relief of symptoms and signs of xerostomia in     comparison with a saliva substitute (European Medical Device).   "
191296|NCT00350363|"     Comparison of 1 day versus 1 hour application of topical Zymar.   "
191297|NCT00350376|"     The primary objective of this web-based, cross-sectional study is to assess and compare the     ability to sleep, work or go to school, and to participate in leisure activities among     subjects who are receiving Xolair treatment and subjects who were eligible to receive Xolair,     but instead have been using Advair for at least 1 year.   "
191298|NCT00350389|"     The purpose of this study is to determine whether the provision of supplementary plain     distance glasses for outdoor use to older users multifocal glasses will reduce falls rates     over a 12 month period.   "
191299|NCT00350402|"     The purpose of this study is to examine the effectiveness of high intensity respiratory     muscle strength training in treating blunted facial expression in people with Parkinson     disease.   "
191300|NCT00350415|"     A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety     and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg     mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).   "
191301|NCT00350428|"     This is a randomised controlled clinical trial to compare laser peripheral iridotomy (LPI)     and primary phacoemulsification with intra-ocular lens implantation (phaco/IOL) in the     treatment of acute primary angle-closure glaucoma (APACG). Following successful medical     lowering of raised intra-ocular pressure (IOP) and control of intraocular inflammation,     patients presenting to Singapore National Eye Centre and Singapore General Hospital with     acute primary angle-closure glaucoma who meet the eligibility are randomised to one of the     two treatment arms: laser peripheral iridotomy and primary phacoemulsification with     intra-ocular lens implantation. These patients will be monitored closely for 2 years     post-operatively.   "
191302|NCT00350441|"     Does pre-operative administration of Sildenafil (Viagra, Pfizer) reduce the lung injury     associated with cardiopulmonary bypass in children undergoing corrective surgical repair of     congenital heart disease.   "
191303|NCT00350454|"     The purpose of this study is to evaluate the efficacy of 3 different rapamycin-eluting-stent     platforms to reduce coronary artery reblockage after stent implantation   "
191474|NCT00345059|"     The purpose of this study is to compare the overall survival of patients with advanced non     small cell lung cancer treated with docetaxel as single therapy versus docetaxel in     combination with either gemcitabine or vinorelbine or in combination with capecitabine.   "
191304|NCT00350467|"     This is a randomized (patients are assigned different treatments based on chance),     double-blind (neither the patient nor the physician knows whether drug or placebo is being     taken, or at what dosage), active-controlled, flexible-dose, parallel group, multicenter     study. The study consists of a screening phase, a double-blind treatment phase (6 weeks) and     a safety follow-up phase (1 week).      The patients in this study will be randomized to 1 of 2 treatment groups to receive extended     release OROS paliperidone or Olanzapine once daily for the 6-week double-blind treatment     phase. Randomization will occur in a ratio of 1 (extended release OROS paliperidone) to 1     (Olanzapine). Patients must be hospitalized at least 14 days after entry. Those who receive     extended release OROS paliperidone will start at a dosage of 6 mg taken daily, dose may be     titrated up by 3mg/day every 7 days, or down rapidly based on the balance of efficacy     (effectiveness of drug) and safety/tolerability assessed by the investigator. After the     initial 7 days, dose could be flexible within 3-12mg/day. Those who receive olanzapine will     start at a dosage of 5mg taken daily, dose may be titrated up by 5mg/day every 7 days, or     down rapidly based on the balance of efficacy and safety/tolerability assessed by the     investigator. After the initial 7 days, dose could be flexible within 5-15mg/day.      Efficacy parameters include Positive and Negative Symptom Scale (PANSS) score, Clinical     Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) score per     assessment visit. The primary efficacy is the change in PANSS from baseline to the last     post-randomization assessment. Safety assessments include the adverse events, changes in     physical examination, vital signs, laboratory tests at pretreatment and posttreatment.   "
191305|NCT00350480|"     To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera)     and a multidose, monophasic combination oral contraceptive in the treatment of     hemodynamically stable women with non-gestational, acute uterine bleeding.   "
191306|NCT00350493|"     This is a three year follow up of a previous study where researchers at UNSW and UNewc asked     smokers with serious mental health problems to participate in a 12-month study, to assess     whether intervention could assist people experiencing mental illness reduce their tobacco     smoking.   "
191307|NCT00350506|"     To compare computed tomography (CT) images (pictures) of the coronary arteries using the     General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients     referred for an x-ray coronary angiography.   "
191308|NCT00350519|"     The primary purpose of the study is to compare the effect of perioperative (the time period     describing the duration of a participants surgical procedure) administration of PROCRIT to     that of Standard of Care (SOC) on the proportion of participants receiving pRBC (packed red     blood cells) transfusions (from the day of surgery to the day of hospital discharge) in     participants undergoing elective major abdominal and/or pelvic surgery. Standard of Care is     defined as the treatment of participants according to the hospital or institution's policy,     but where participants will not receive PROCRIT (Epoetin alfa) or any other     erythropoiesis-stimulating agents (ESAs) (agents that stimulate the production of red blood     cells in the bone marrow).   "
191309|NCT00350532|"     The purpose of this study is to compare the amount of acetylcholine release after a single     injection of clonidine in normal volunteers and individuals with neuropathic pain.   "
191310|NCT00350545|"     We hypothesize the addition of rituximab to prednisone for the initial treatment of chronic     GVHD will increase the overall response rate, and enable a more rapid and effective steroid     taper.   "
191311|NCT00350571|"     We will evaluate a series of interventions intended to help individuals who drop out of     substance abuse treatment re-engage in order to improve treatment outcome.   "
191312|NCT00350584|"     Posttraumatic Stress Disorder (PTSD) is very prevalent within the veteran population and is     associated with decreased quality of life and an increased risk of developing other     psychiatric and physical illnesses. The overarching objective of the proposed study is to     evaluate the effectiveness of two telehealth treatment conditions in promoting healing within     a population of veterans with full or partial PTSD. In particular, we are targeting newly     returned veterans from the Iraq and Afghanistan conflicts. Specifically, we are comparing the     relative efficacy of an alternative therapeutic approach, a Mindfulness based treatment, with     a Psychoeducation treatment in reducing symptoms of PTSD and more generalized psychiatric     symptoms, while increasing quality of life. Of note, both treatment conditions will consist     of two in-person sessions and six brief weekly telephone calls. Participants will be 58     veterans (29 per condition) recruited from the VA Boston Healthcare System. Assessment will     occur before and after the delivery of the intervention. We hypothesize that while both     treatments will result in improved outcomes, the Mindfulness intervention will promote more     healing than the Psychoeducation intervention. Results from this project will help further     our understanding of the role of mindfulness in treating PTSD, particularly in those veterans     who are returning from deployment.   "
191313|NCT00350597|"     This is a pilot study to describe the immunological responses and clinical outcome associated     with administration of recombinant human Granulocyte Macrophage Colony Stimulating Factor     (GM-CSF) as surgical adjuvant therapy in patients with malignant melanoma who are at high     risk for recurrence (Stage II T4, III and IV).   "
191314|NCT00350610|"     The computer-based training program (CBT for CBT) focuses on teaching basic coping skills,     presenting examples of effective use of coping skills in a number of realistic situations in     video form, and providing opportunities for patients to practice and review new skills while     receiving substance abuse treatment.   "
191315|NCT00350623|"     This study will test the safety and immunogenicity of an investigational Human     Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the     immune response to several different dose levels.   "
191316|NCT00350636|"     A new drug for overactive bladder is compared to placebo to determine if it is safe and     effective. The study lasts approximately 12 weeks.   "
191320|NCT00350688|"     While the gold standard of treatment in invasive bladder cancer is surgical removal of the     bladder, it is well accepted that a reasonable alternative is an organ preserving approach.     Bladder preservation can be achieved in patients with radiotherapy alone or together with     concurrent chemotherapy. This clinical trial will assess the potential of intensity modulated     radiation therapy (IMRT) delivered using helical tomotherapy to reduce radiation-induced     gastrointestinal toxicity and increase the accuracy of bladder cancer irradiation.   "
191324|NCT00350753|"     Erlotinib and bevacizumab have shown activity individually, as single drugs, or in     combination with chemotherapy in upper gastro-intestinal cancers, including esophageal and     gastro-esophageal adenocarcinomas, gastric cancer and pancreatic cancer. Biomarkers     indicating an important role of EGF and VEGF have been found in these tumors, and in     cholangiocarcinomas as well. There is promise that combined treatment with erlotinib and     bevacizumab is active and tolerable in a broad range of upper gastro-intestinal cancers,     justifying an experimental phase II-study of patients with these diagnoses, refractory or     intolerant to standard systemic therapy.   "
191325|NCT00350766|"     The purpose of this study is to determine cell therapy efficacy in patients with ST elevation     acute myocardial infarction (STEMI)   "
191326|NCT00350779|"     A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2     Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome     proliferator-activated receptor gamma (PPARg) agonist combination therapy.   "
191327|NCT00350792|"     A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed     and Carboplatin in elderly patients with advanced non-small cell lung cancer   "
191328|NCT00350805|"     Abnormalities in the ability to distinguish events in time may have a great impact on     everyday life. The main objective of the study is to evaluate the magnitude of the temporal     windows in schizophrenia, i.e. the time interval during which two events are perceived as     synchronous. The investigators test the hypothesis that these temporal windows are enlarged,     and check the relationship between this impairment and disorganization symptoms, in order to     explore the link between this cognitive impairment and clinical symptoms. They explore also     the neurobiological bases of the impairment by means of electroencephalogram (EEG)     recordings. Event-related potentials (N50) will reveal whether or not the coding of the     stimuli has the same temporal characteristics in patients and controls. The distribution and     amplitude of oscillatory activities will be analyzed as a function of the synchronous or     asynchronous response of the subject, thus allowing to explore the links between synchrony     perception and neuronal synchronization phenomena.   "
191329|NCT00350818|"     Primary Objective:      -To determine the dose and schedule combination of 5-Azacitidine, when used as maintenance     treatment after allogeneic transplantation for high-risk AML / MDS.      Secondary Objective:      -To assess the effect of treatment on survival after allogeneic transplantation for high-risk     AML / MDS.   "
191330|NCT00350831|"     The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820     when given orally daily to adults with advanced solid tumors.   "
191331|NCT00350844|"     The goal of this study is to test the hypothesis that hydroxyurea is effective for the     specific treatment of secondary pulmonary hypertension found on screening in children and     young adults with sickle cell disease.   "
191332|NCT00350857|"     To examine the safety and effectiveness of extended-release carbamazepine in the treatment of     children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.   "
191333|NCT00350870|"     This is a study of four treatments for chronic cocaine use and may help study participants to     control their drug use. All participants will receive weekly individual cognitive behavioral     therapy (CBT).   "
191334|NCT00350883|"     This clinical trial tests the effectiveness of cognitive therapy (CT) to improve outcomes in     outpatients diagnosed with schizophrenia or schizoaffective disorder who manifest prominent     negative symptoms. It is hypothesized that patients receiving cognitive therapy will manifest     lower negative symptom levels and improved engagement in constructive activity relative to     patients who receive treatment-as-usual. Further, it is predicted that these differences     between CT and TAU will be larger when patients are assessed 6 and 12 months after the end of     treatment (18 and 24 months after study entry).   "
191335|NCT00350896|"     The prevalence of digital osteoarthritis varies according to whether a radiological or     clinical definition is adopted.      Interventions: Thumb orthoses to be worn at night and usual care vs usual care. Outcome     measures: Pain at 1 month assessed on visual analog scale is the main outcome measure.     Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main     secondary outcome measures.   "
191336|NCT00350909|"     The purpose of this clinical trail is to evaluate the efficacy of a brief,     cognitive-behavioral therapeutic intervention for adolescents reporting mild or moderate drug     abuse (MMDA). This school-based initiative employs a collaborative effort between the     University of Minnesota researchers and the St. Paul Public Schools. This intervention aims     to reduce post-treatment drug use behaviors and enhance drug-use resistant cognitions and     problem-solving skills.   "
191337|NCT00350922|"     The purpose of this clinical trial was to determine the effectiveness of a supportive and     educational self-management program for improving health-related quality of life (HRQOL),     angina symptoms, and self-efficacy and resourcefulness to self-manage for chronic angina     patients. 130 participants were enrolled in the trial for 3 months. The program, entitled the     Chronic Angina Self-Management Program, (CASMP) was found effective for improving HRQOL,     angina symptoms, and self-efficacy to manage symptoms, compared to usual care.   "
191338|NCT00350935|"     The main objective of the study is to contribute to a better understanding of the     physiopathology of schizophrenia, by studying causal relationships between cognitive deficits     and the neurobiological basis for these deficits. Processing visual information involves both     automatic grouping processes and control processes. Automatic grouping processes allow the     building of a global configuration from local contour information. It is necessary in order     to recognize objects. Control processes allow tending to and prioritizing information parts.     The paradigm the investigators use allows to dissociate these processes, and is used in order     to characterize the impairments observed in patients with schizophrenia. It is adapted to     fMRI in order to explore the neurobiological basis of the deficits. The investigators will     examine whether functional disconnectivity between activated areas subtend the impairments     observed in patients.   "
191339|NCT00350948|"     The purpose of this research study is to determine if Telcyta® given in combination with     liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women     who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal     cancer that is refractory or resistant to platinum chemotherapy.   "
191340|NCT00350961|"     In Denmark approximately 200 new cases of cholangiocarcinoma are diagnosed every year. No     standard treatment exists for patients with advanced cholangiocarcinoma, and improved     systemic treatments are needed.      Duplets of gemcitabine, oxaliplatin and capecitabine have been evaluated in various cancers     and several different regimens are well tolerated and active, especially in upper     gastrointestinal cancers, exocrine pancreatic cancer and non-small cell lung cancer.      The triplet combination of these agents has not been studied, but a triplet combination of     gemcitabine, oxaliplatin and 5-FU infusion has been evaluated in a phase I study.      Bi-weekly combination of gemcitabine and oxaliplatin has proven active and tolerable and     warrants further study. In addition, fixed dose rate infusion of gemcitabine has shown     interesting as the ability of mononuclear cells to accumulate gemcitabine triphosphate during     therapy seems to be saturable.      We propose a phase I-II study of a bi-weekly schedule of gemcitabine, oxaliplatin and     capecitabine. This regimen could be feasible in an out-patients setting.      The phase I part is a standard dose escalation study for patients with solid tumors. In the     phase II part the recommended dose is studied in patients with advanced cholangiocarcinoma.   "
191341|NCT00350974|"     Asymmetric dimethylarginine, ADMA, in plasma, is significantly elevated in patients with     renal disease and associated with cardiovascular morbidity and mortality. We found that whole     blood (WB) possesses the metabolic pathways required for both the generation and elimination     of ADMA and we have developed ex vivo methods to assess the WB accumulation of ADMA in     humans. The over-arching hypothesis is that dysregulation of ADMA metabolic pathways leads to     greater ADMA whole blood content and greater capacity to accumulate ADMA, which 1) is not     reflected by plasma levels and 2) is a better predictor of cardiovascular outcome than plasma     levels in end-stage renal disease (ESRD). The following specific aims will be pursued to     characterize whole blood ADMA in ESRD:        1. Compare and contrast baseline free plasma ADMA and total whole blood (free plus          protein-incorporated) ADMA concentrations in ESRD patients, matched hypertensive          controls and a normal population.        2. Determine the capacity of WB to accumulate (the net balance of generation and          elimination) ADMA in ESRD patients, matched hypertensive controls and a normal          population.      We will use state-of-the-art, high performance liquid chromatography techniques to measure     ADMA levels in plasma and whole blood. Samples for ADMA measurements will be obtained from     subjects with end-stage renal disease immediately before their dialysis treatments. Samples     will also be obtained from volunteers without kidney disease. This group will be matched to     the end-stage renal volunteers by age, gender and ethnicity. These volunteers will also be     matched for the presence of hypertension and diabetes. The third group will consist of a     normal population to measure the normal levels of ADMA and compare to the other two groups.      There is growing evidence to support a pathological role of ADMA in humans. These experiments     will enhance our understanding of how ADMA is processed in the human body and how it is     associated with kidney disease. Potentially, these results will lay the groundwork for new     insights into the link between ADMA and the high cardiovascular disease burden in patients     with kidney disease.   "
191342|NCT00350987|"     The aim of this study is to test if procalcitonin (PCT) guided antibiotic stewardship in     patients with lower respiratory tract infection (LRTI) will be non-inferior, with at worst a     7.5% higher combined failure rate, as compared to standard care practice (current guidelines     for LRTI) with reduced total antibiotic (AB) use and hospitalization rate and duration,     respectively.   "
191343|NCT00351000|"     This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone,     added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients     with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective     disorder. The first two weeks will be a fixed-dose of ziprasidone 40 mg twice a day. During     weeks 2-6, the ziprasidone dose may be increased up to 80 mg twice a day.   "
191344|NCT00351013|"     Malaria accounts for over 40% of outpatient morbidity in Sierra Leone. These health risks     have been heightened further by the recent civil war, persistent poverty, lack of access to     affordable health care, and an increasing resistance of P.falciparum parasites to the most     commonly used therapy Chloroquine, which now has a confirmed failure rate of 39%. This study     will recruit 780 people from the Kroo-Bay community in Freetown. Healthy subjects would be     randomised into two subgroups and given either homeopathic pellets or placebo tablets at four     month intervals. They are then monitored repeatedly during the study period to assess the     efficacy of the therapy in reducing the disease burden.   "
191345|NCT00351026|"     Treatment of opioid dependence is an important way to reduce the spread of HIV and other     infectious diseases, particularly in Ukraine since intravenous opioid use is the major way     these infections are being spread. This proposal will be done at the Kiev City Narcology     Hospital and the City AIDS Center with collaborators from the University of Alabama and the     University of Colorado. It will study the acceptability and impact of a 3-month course of     methadone maintenance on 50 persons with opioid dependence, 25 who are HIV+ and 25 HIV-. The     proposed work will build on a relationship that was established with the Ukrainian     Co-Principal Investigator, Sergiy Dvoryak, M.D., during his Humphrey Fellowship at Johns     Hopkins in 1999-2000 when he spent time with Dr. Woody and Metzger at the Penn Addiction and     Treatment and Research Center. It will also extend studies of pharmacologic treatment for     opioid dependence and risk reduction behavioral interventions that are being done by Drs.     Woody, Schumacher and Booth in Russia and Ukraine. Primary aims are to: measure the     acceptability and compliance with a 3-month course of methadone maintenance in HIV+ and HIV-     patients; measure the impact of a 3-month course of methadone in reducing opioid use in HIV+     and HIV- patients; measure the impact of a 3-month course of methadone on reducing HIV risk     behavior in HIV+_and HIV- patients. Secondary aims are to: assess the degree to which a     3-month course of methadone maintenance reduces illegal activities and improves employment     and psychiatric symptoms; determine short-term outcome after completion of methadone     treatment; and obtain pilot data on the prevalence of hepatitis B and C among study patients.     This study will provide pilot data on the acceptability and efficacy of a short-term course     of methadone maintenance on HIV+ and HIV- persons in a setting where this treatment has not     been evaluated, on the feasibility of conducting the kind of work that is proposed, and will     enhance research capabilities of Kiev investigators for future HIV prevention and treatment     studies.   "
191346|NCT00351039|"     This is a Phase I/II trial of elderly patients (> 70 years of age). Patients in this age     group with previously un-treated Advanced Stage Non-Squamous Non-Small Cell Lung Cancer     (NSCLC) with Stage IIIB (with malignant pleural effusion) and stage IV disease will be     enrolled. Therapy consists of three drugs (Premetrexed[Alimta™], Bevacizumab and     Erlotinib[Tarceva™]) which are given every 28 days.   "
191347|NCT00351052|"     This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric     atopic dermatitis   "
191348|NCT00351065|"     This study was designed to evaluate the efficacy and safety of the SK3530 tablet and to find     the optimal dose and dosage schedule after oral administration to patients with erectile     dysfunction.   "
191360|NCT00351221|"     The trial will investigate the treatment of growth failure in children with Noonan syndrome.     Abnormalities in the growth hormone (GH) – insulin-like growth factor-I (IGF-I) axis     resulting in low IGF-I levels have been suggested as a possible cause of short stature seen     in Noonan syndrome children. Administration of our investigational product is intended to     bypass the abnormalities in the GH-IGF axis, and hopefully improve body growth.   "
191361|NCT00351234|"     The purpose of this study is to determine whether type I diabetics with carnitine deficiency     exhibit increased numbers of hypoglycemic (low blood sugars) events and if unrecognized     hypoglycemia occurs during continuous 72-hour glucose monitoring. If they are determined to     have unrecognized hypoglycemia, then oral carnitine supplementation will be given to those     subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour     glucose monitoring.   "
191349|NCT00351078|"     In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation     (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator     (CFTR) protein. PTC124 has been shown to partially restore CFTR production in animals with CF     due to a nonsense mutation. In an ongoing Phase 2a study being performed at the Hadassah     University Hospital - Mount Scopus in Israel, patients with nonsense-mutation-mediated CF     have received PTC124 in two 14-day treatment courses. Preliminary results from that study     indicate that PTC124 has pharmacodynamic activity of PTC124 in CF and that PTC124 can be     safely administered in this patient population. This Phase 2b extension study is designed to     evaluate the activity and safety of 3 months (approximately 84 days) of continuous treatment     with PTC124 in the same patients who were enrolled to the Phase 2a study. The main purpose of     this study is to understand whether PTC124 can be safely administered and achieve     pharmacodynamic activity in patients with CF due to a nonsense mutation.   "
191350|NCT00351091|"     The primary objective of this pilot study is to estimate the percent change from baseline at     Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate     administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment     period both compared to a 5 mg daily dose of risedronate for 6 months      The secondary objectives are :        -  To estimate the percent change from baseline at specified visits other than Week 4,          Month 6 in NTX for the monthly 150 mg dose of risedronate administered for 6 months and          the loading dose regimen of risedronate over a 6 month treatment period both compared to          the 5 mg daily dose of risedronate.        -  To estimate the percent change from baseline at all specified visits in serum CTX and          bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate          administered for 6 months and the loading dose regimen of risedronate over a 6 month          treatment period both compared to the 5 mg daily of risedronate.        -  To estimate the percent change from baseline at Month 6 in lumbar spine BMD for the          monthly 150 mg dose of risedronate administered for 6 months and the loading dose          regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily          dose of risedronate.        -  To evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.   "
191351|NCT00351104|"     The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain     associated with ankle sprain or strain.   "
191352|NCT00351117|"     This trial will test the efficacy of St. John's Wort (SJW) as a supplement, in the treatment     of Raynaud's phenomenon (RP). The investigators are hypothesizing that taking SJW 300mg, 3     times a day will decrease the frequency, duration, and severity of RP attacks when compared     to placebo.      Patients with RP will answer questionnaires and self-evaluate their symptoms of RP as a     baseline. Then they will be assigned to either a treatment (will receive SJW capsules) or     placebo (will receive non-therapeutic capsules) group. They will be required to take their     capsules, self-evaluate their progress and be evaluated every two weeks in a clinic. The     treatment phase will last six weeks.      This trial will be conducted in a way to mimic the normal usage of natural products. Patients     will not be required to stop any current treatment for RP.   "
191353|NCT00351130|"     Essential hypertension is a widespread disease which affects one out of every three adults in     the industrialized world. It contributes to cardiovascular disease development, a major and     well established risk factor. A patient non compliant to drug therapy is recognized as one of     the primary reasons for inadequate blood pressure control.   "
191354|NCT00351143|"     This study will investigate whether study subjects with previously uncontrolled asthma     treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of     Total Control of their condition and whether adherence to treatment can be enhanced by     teaching the subjects. Two groups of equal size with identical medical treatment will be     compared with each other, the test group receiving three training modules during study visits     and the control group regular study visits only.   "
191355|NCT00351156|"     The purpose of this study is to learn more about Gaucher disease. The information we collect     from medical histories and a blood sample from people with Gaucher disease may help us     pinpoint certain things that are different between people who have Gaucher disease and people     who do not have Gaucher disease. This information may be useful in the future to help find     new treatments for Gaucher disease.   "
191356|NCT00351169|"     To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in     the treatment of Major Depressive Disorder.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
191357|NCT00351182|"     New antibiotics are required that have antibacterial activity against doxycyline resistant O.     tsutsugamushi, that can be safely used in pregnant women and children, that have a low     possibility of inducing resistance and that do not induce cross resistant to other     antibiotics. Telithromycin has been reported to be effective on Rickettsia, Batonella and     Coxiella burnetii. Therefore, telithromycin may be considered as a substitute antibiotic that     can be used safely in pregnant women and children for rickettsiosis or Orientia infection.     Our study was designed to prove the clinical usefulness of telithromycin by comparing it with     doxycycline for treating mild or moderate scrub typhus.   "
191358|NCT00351195|"     Various cytotoxic agents have been evaluated in advanced hepatocellular carcinoma, but     response rates have been low with significant toxicity, most often due to parenchymal liver     disease. The three agents etoposide, oxaliplatin and capecitabine each has sparse efficacy as     single agents, but the combination may act synergistically with an acceptable toxicity     profile.   "
191359|NCT00351208|"     The purpose of the study is to measure the efficacy of varying spinal cord stimulation     frequencies and pulse-width settings on chronic pain management. The spinal cord stimulator     settings that are most effective in chronic pain management hope to be revealed for the     purposes of this study. In this double-blind study, both the patient and the staff will not     be aware of the spinal cord stimulator settings for each patient each week. The     representative that will set the settings each week will be blinded to the identity of each     patient and will set the spinal cord stimulator from another room. While there are few papers     that show the efficacy of spinal cord stimulation in treating chronic pain, there has yet to     be a study performed that measures the role of stimulation frequency and pulse-widths. This     study hopes to be the first.   "
191364|NCT00351273|"     Reactive arthritis, also known as Reiter's syndrome, is a form of arthritis that occurs as a     reaction to an infection elsewhere in the body. It is characterized by inflammation of the     joints, tendons, urogenital tract, and eyes. Pain and swelling in the knees, ankles, and feet     are common. This study will determine the effectiveness of antibiotic therapy in treating     people with chlamydia-induced reactive arthritis that has lasted for more than 6 months.   "
191365|NCT00351286|"     To prove the combination of L-citrulline with simvastatin leads to greater improvement in the     symptoms of peripheral arterial disease (PAD) than simvastatin alone by evaluating oral L-     citrulline or placebo against simvastatin for improvement in treadmill walking distance in     patients, 40–75 years of age, who have PAD with intermittent claudication.   "
191366|NCT00351299|"     The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect -     a sedative) is effective for the treatment of acute delirium   "
191367|NCT00351312|"     Evaluation of the ability of socks weaved with pressure relieving areas to reduce the     pressure on the foot when weight bearing.   "
191368|NCT00351325|"     The purpose of this study is to assess the safety and tolerability of multiple escalating     doses of BMS-663513 when given in combination with paclitaxel and carboplatin.   "
191369|NCT00351338|"     Although morbidly obese subjects have larger than regular caloric intake, there is evidence     that they suffer from nutritional deficiencies at a higher rate than the general population,     probably because they eat mostly unhealthy food.   "
191370|NCT00351351|"     Percutaneous nephrolithotomy (PNL), in conjunction with intracorporeal lithotripsy, allows     for the rapid removal of any kidney stone regardless of size. Currently, the choice of     intracorporeal lithotripters includes ultrasonic, pneumatic, and combined     ultrasonic/pneumatic energy sources. Recently, a novel dual probe design as been introduced     by Cybersonics of Erie, Pennsylvania. This dual probe intracorporeal lithotrite is called the     Cyberwand, and is composed of a fixed inner probe vibrating at an ultrasonic frequency with     an outer probe vibrating at about 1,000 Hz. As this new design has the potential to     revolutionize intracorporeal lithotripsy, we intend to compare this novel technology to     currently available lithotripsy technology in a randomized clinical trial.   "
191371|NCT00351364|"     To evaluate the effect of the drug Montelukast on the brachial artery's function. By giving a     drug like Montelukast, which blocks the effects of inflammation in the lungs arteries and     controls asthma, we hope to see positive effects in other arteries such as in the heart.   "
191372|NCT00351377|"     Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in     gastrointestinal (GI) complications in some patients. This study will 1) determine the     proportion of patients with autoimmune diseases who are experiencing any GI complaints under     MMF-based immunosuppressive treatment and 2) assess if a switch from MMF to enteric-coated     mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life     outcomes.   "
191374|NCT00351403|"     Patients with chronic hepatitis C genotype 1 virus infection are usually treated with     Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for     others too short. An individually adapted therapy length from 24 to 72 weeks will be     determined in dependence of the initial virus load and the time to HCV RNA negativity.      The primary objective is to compare the cumulative rate of the sustained viral response (SVR)     of the patients with the individually adapted therapy duration to the SVR rates of a historic     patient collective under the 48 week standard therapy.   "
191375|NCT00351416|"     This research study involves the use of the drugs Letrozole, GnRH, and NAL-GLU GnRH     antagonist. Letrozole is a drug that is approved by the U.S. Food and Drug Administration     (FDA) for use in breast cancer treatment that has been found to block the formation of     estrogen. The NAL-GLU GnRH antagonist is a drug that temporarily blocks the action of GnRH.     GnRH is a hormone that the body makes that stimulates other hormones that then control the     function of the ovary.      The purpose is to study the effects of the administration of letrozole in women with GnRH     deficiency at the same time that they receive gonadotropin-releasing hormone (GnRH). In     addition, administration of letrozole and NAL-GLU GnRH antagonist in healthy women with     normal menstrual cycles will be done to evaluate the role of estrogen in the control of the     hormone FSH, or Follicle Stimulating Hormone, in the female reproductive cycle. A better     understanding of FSH control may help in the development of new treatments for women with     difficulty conceiving.   "
191376|NCT00351429|"     To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical     procedures   "
191377|NCT00351442|"     Some people who are exposed to the HIV-1 virus are capable of either controlling or     completely preventing viral infection. Multiple genetic factors may contribute to preventing     or controlling HIV-1 infection. The purpose of this study is to analyze the immune system     responses of individuals who are exposed to HIV-1 but remain uninfected.   "
191378|NCT00351455|"     This study is being conducted to gain a better understanding of the quality of life for     patients with a diagnosis of primary and recurrent incisional hernias and 1) who decline to     have surgery to repair the hernia or 2) patients who cannot have surgery because their health     will not allow them or 3O if surgery to repair the hernia is completed. A comparison will be     made between those who receive surgery and those who do not.   "
191639|NCT00353444|"     The purpose of this study is to determine whether Transcranial Doppler measurements have     correlation with neuropsychological test (Galvestone Orientation Amnesia Test), TC image     (Marshall Scale) and prognosis (DRS and GOS) in moderate head injury   "
191379|NCT00351468|"     An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of     eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who     have previously been enrolled in an eltrombopag trial. This study will allow adjustment of     the eltrombopag dose to achieve an individualized dose and schedule for each subject. In     addition, the ability to reduce the dose of concomitant ITP medications in the presence of     eltrombopag, while maintaining platelet counts = 50,000/μL will be investigated.   "
191397|NCT00338416|"     The purpose of this study is to determine the effectiveness and safety of PROCRIT (Epoetin     alfa) at a starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb)     of 12 g/dL (Initiation Phase), followed by a dose of 80,000 Units once every three weeks     (Q3W) to maintain a Hb range of 11.5 to 12.5 g/dL (Maintenance Phase) in cancer patients     receiving chemotherapy.   "
191380|NCT00351481|"     We will investigate maternal and embryonic factors in women with recurrent implantation     failure, undergoing IVF/ ICSI treatment. Women who have not achieved a pregnancy after three     embryo transfer procedures will undergo an endometrial biopsy during the window of     implantation in a natural cycle. During the next treatment cycle we will aspirate endometrial     secretion and perform a doppler ultrasound investigation of the a. uterina. Moreover, we will     investigate the cytokine expression from the transferred embryo from the culture medium.   "
191381|NCT00351494|"     Contrast-enhanced ultrasound is supposed to improve the detection of myomas as well as     improve the follow-up after specific treatments like embolization. It will also help the     investigators better understand the mechanism of success or failure for embolization and     could reduce the amount of particles injected by determining the endpoint of the procedure in     order to treat the myomas while preserving the myometrium.   "
191382|NCT00351507|"     This study was designed to directly assess the effects of vildagliptin on gastric emptying in     people with type 2 diabetes.   "
191383|NCT00351520|"     Cutaneous leishmaniasis is a parasitic skin lesion caused by different species of Leishmania     and transmitted by the bite of infected sand flies. Leishmaniasis is exist in 88 countries,     pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a     standard treatment for this disease for last 80 years. Pentavalent antimonials are only     available as injectable, which is painful, toxic, not affordable and moreover is not always     effective even sometimes with several courses of treatment. Many different modalities are     used to treat the disease with little success. Miltefosine is drug and has recently been     shown to be effective in the treatment cutaneous leishmaniasis in Colombia. The molecular     mechanisms that contribute to this effectiveness are not clearly understood. Only a well     designed, randomized clinical trial can precisely evaluate the efficacy of any therapeutic     modalities in cutaneous leishmaniasis. In this study the efficacy of oral treatment of     miltefosine 2.5 mg per Kg body weight for 4 weeks will be compared with standard treatment of     intramuscular injections of 60 mg/kg/day glucantime for 2 weeks in ACL parasitologically     proven patients. At 8 weeks after the initiation of the treatment any patient in the group     who received miltefosine and has not responded to the treatment will be treated with the     standard intramuscular injections of 60 mg/kg/day glucantime for 2 weeks. The clinical trial     will be carried out according to the International approved GCP (Good Clinical Practice)     guide lines.   "
191384|NCT00351533|"     The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids)     given enterally is safe and effective in reducing lung and systemic inflammation seen in     acute lung injury.   "
191385|NCT00351546|"     Type 2 diabetes results when the body does not produce enough insulin and/or is unable to     properly use the insulin it makes (insulin resistance). This study was undertaken to assess     the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.   "
191386|NCT00351559|"     This study is designed to evaluate the safety and efficacy of a leukocyte gene expression     profiling method in the monitoring of asymptomatic heart transplant patients for acute     rejection.   "
191387|NCT00351572|"     This study will determine whether a new diagnostic test called the Cell Search Assay can     detect circulating colon cancer cells in patients who have had surgery for colon cancer and     had visible cancer removed. Other parts of the study will look at whether the presence of the     circulating tumor cells in blood predicts whether a patient will have their colon cancer     return.   "
191388|NCT00351585|"     Type 2 diabetes results when the body does not produce enough insulin to regulate blood     sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin     secretion by the pancreas.   "
191389|NCT00338312|"     This study is designed to evaluate efficacy and safety of a testosterone patch as treatment     for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin     therapy.   "
191390|NCT00338325|"     This study is designed to implement the reading of age appropriate books by a trained reader     into the waiting area of a pediatric day surgery unit to determine if it is effective at     reducing the anxiety and pain levels of parents and children by providing a safe and calming     activity for the child. This is a single-centre trial based at the IWK Health Centre. The     primary outcome will be based on the anxiety and pain scores of the research participants.   "
191391|NCT00338338|"     The sustained reduction in elevated blood pressure and lower incidence of adverse events of     Lacidipine may provide additional benefits for hypertension patients than other CCBs (calcium     channel blockers). This study is to compare the efficacy and safety of Lacidipine with     Amlodipine, the most widely used CCB in Taiwan, in hypertensive patients.   "
191392|NCT00338351|"     Three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants     between 6-12 weeks of age at the time of the first vaccination against Streptococcus     pneumoniae.   "
191393|NCT00338364|"     This study is designed to assess the effectiveness of the video-based intervention over and     above current standard practice for pain control in the pediatric emergency department (ED).     This is a single-center trial based at the IWK Health Centre. The primary outcome will be     based on the CAMPIS coding of the video-taped pain response of the research participants.   "
191394|NCT00338377|"     Objectives:      The primary objective will be to determine whether patients receiving the combination of     dendritic cells and high dose IL-2 have sustained persistence of infused T cells compared to     patients treated with T cells and high dose IL-2 alone.      Secondary endpoints will include evaluations for tumor response and studies to determine     whether dendritic cells enhance the infused T cells in anti-tumor activity and their ability     to migrate to the tumor site. In addition, we will evaluate the characteristics of the     infused T cells that correspond with effectiveness in vivo.   "
191396|NCT00338403|"     We hypothesize that continuous positive pressure applied to the airway will decrease the     ability of the nose to warm and humidify inspired air compared to zero or negative pressure.      We will use continuous positive airway pressure (CPAP), a device commonly used to treat     patients with sleep apnea, to vary the pressure in the airway and determine if increased     pressure decreases the ability to warm and humidify inspired air. If our hypothesis is     correct, it may explain the reason why CPAP is poorly tolerated in patients with sleep apnea;     i.e., less ability to warm and humidify air leading to more nasal mucosal irritation.   "
191398|NCT00338429|"     The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the     effectiveness of the Strongest Families distance intervention compared to usual or standard     care that is typically provided to children with mild to moderate sleep onset latency and/or     bedtime resistance difficulties. This is a single-centre trial based at the IWK Health     Centre. The primary outcome is change in sleep patterns (sleep onset latency and/or bedtime     resistance).   "
191399|NCT00338442|"     This study is to assess VariZIG™ for the treatment of patients at risk for developing serious     complications from chicken pox.   "
191400|NCT00338455|"     The purposes of this study in United Network for Organ Sharing (UNOS) Status 1B (or country     equivalent) cardiac transplant candidates are to assess the safety and efficacy of Natrecor     (nesiritide). The study will evaluate the drug's ability to prevent clinical worsening when     administered as a 28-day continuous intravenous infusion in patients receiving standard care     and continuous intravenous infusion of dobutamine or milrinone.   "
191401|NCT00338468|"     The purpose of this study is to assess disability in anemic patients over the age of 65 who     have kidney disease and are receiving weekly PROCRITÂ® (Epoetin Alfa, a glycoprotein that     stimulates red blood cell production).   "
191402|NCT00338481|"     The purpose of this study is to test whether red morphine drops applied in the mouth are     superior to an equivalent amount of morphine applied as subcutaneous injection for the relief     of breathlessness in terminal patients suffering from primary lung cancer or lung metastases.   "
191403|NCT00338494|"     Clofarabine is a new chemotherapy drug which was FDA approved for the treatment of acute     lymphocytic leukemia in children. This study is being done to see if Clofarabine works in     adult patients with B-cell types of lymphoma.      This research is being done to develop new treatments for patients with lymphoma whose cancer     has returned or resisted treatment with previous chemotherapy.   "
191404|NCT00338507|"     This clinical study is designed to explore dose ranging and identify methods to demonstrate     the efficacy of Erdosteine in patients with stable Chronic Bronchitis associated with Chronic     Obstructive Pulmonary Disease.   "
191405|NCT00338520|"     The purpose of this study is to see if children, who develop coma from malaria, are not     making enough of a vitamin-like chemical, tetrahydrobiopterin (BH4), which is required for     the brain to function normally. This information may help to identify new ways to treat     malaria in the future. Study participants will include 512 children, ages 6 months to 6     years. Participants will be placed into one of 4 groups: well children; children with mild     malaria; children without malaria, but with a medical problem involving the brain that     requires a lumbar puncture for diagnosis (a procedure in which a needle is placed into an     area surrounding the spinal cord and a sample of cerebral spinal fluid is removed); and     children with a severe form of malaria affecting the brain called cerebral malaria. Study     procedures will include blood samples, urine samples and lumbar puncture, only if necessary     for diagnosis as part of standard practice procedures. Participants will be involved in study     related procedures for up to 3 weeks.   "
191406|NCT00338533|"     Glaucoma surgery is performed on children less than 3 years old for infantile glaucoma which     untreated can cause blindness. Glaucoma is an uncontrolled high eye pressure in these     children often due to incomplete development of the part of the eye which normally allows     fluid to drain out of the eye. Two procedures are possible and equal in their success of     lowering the eye pressure. However, one (the goniotomy procedure) is preferred since it takes     10 minutes rather than 1 hour (for the trabeculotomy procedure) to perform under general     anesthesia. This is important in young children to reduce anesthesia exposure especially if     both eyes need surgery. If the glaucoma has caused the cornea or front of the eye to become     too cloudy, then the view is too poor to place a lens on the cornea and use a needle to     perform the shorter procedure. However, a small endoscope which has been FDA approved for use     in the eye will allow direct viewing of the area which needs treatment. A needle attached to     this endoscope allows the shorter goniotomy to be performed rather than proceeding to the     longer trabeculotomy procedure. The outcome measure of this study is anesthesia time and     reduction in intraocular pressure .   "
191407|NCT00338546|"     The purpose of this study is to improve the scientific understanding of the cardiovascular     actions of cocaine, in particular the ability of cocaine to increase blood pressure.   "
191408|NCT00338559|"     The effect of airway management on vomiting after strabismus surgery is unknown. The purpose     of this study is to find out whether the use of different airway devices, such as LMA, which     is a special mask placed in the throat or Endotracheal tube (ET tube), which is a soft tube     placed in the wind pipe, affects the incidence of vomiting after surgery. Two hundred six     children between the ages of 2 and 12 years are expected to take part in this study.   "
191409|NCT00338572|"     In addition to high blood pressure, hypertension is characterized by inflammation, which is     the body's response to injury or infection. Inflammation has been found to cause plaque     formation on artery walls. This study will compare the effect of an exercise program versus a     combined exercise and diet program on reducing inflammation in hypertensive individuals.   "
191410|NCT00338585|"     The purpose of this study is to directly compare the safety and efficacy of intra-thrombus     alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured     by a 30 day open vascular free surgery rate.   "
191411|NCT00338598|"     This placebo-controlled study is designed to evaluate the efficacy of glycine, an agonist of     the glycine-B co-agonist site of the NMDA receptor, on alcohol consumption and craving as     well as negative symptoms in schizophrenia.      Glycine will decrease the rewarding action of ethanol and reduce ethanol consumption. Also,     glycine will improve negative symptoms and cognitive deficits in schizophrenia.   "
191412|NCT00338611|"     The purposes of the CITT are:        -  To determine whether Home-based Pencil Push-up therapy, Home-based Pencil Push-ups with          Computer Vision Therapy/Orthoptics or Office-based VT/Orthoptics more effective than          placebo treatment, and whether there are differences between the three treatments in          improving subject symptoms and signs.        -  To evaluate whether improvements in outcome measures are still present after one year of          observation.   "
191413|NCT00338624|"     The purpose of this study is to evaluate the safety and effectiveness of oxybutynin extended     release tablets 10 mg plus tamsulosin HCl 0.4 mg in the treatment of lower urinary tract     symptoms as measured by change of the total International Prostate Symptom Score (I-PSS) from     baseline to Week 12 or the Final Visit.   "
191414|NCT00338637|"     Randomised double blind study of two parallel groups,one of the groups trained with the full     APOS kit (a shoe with an additional bio mechanical device)      The control group trained with the Apos shoe without the bio mechanical device. both groups     will be checked at the beginning of the study, one month later and at the end of the study     after two months. The tests include neurological test, functional test(FSST,up and go test     and berg balance test) gate analysis and quality fo life (rays) test.   "
191415|NCT00338650|"     The primary objective of this study is to make adalimumab available to patients suffering     from moderately to severely active Crohn's Disease who have failed to respond to, lost     response to, or are intolerant to infliximab, and to evaluate safety   "
191416|NCT00338663|"     The purpose of the study is to determine if there is difference in immediate postoperative     pain levels (48 hours) between patients who wear a knee immobilizer splint compared to     patients who do not wear a knee immobilizer splint after an anterior cruciate ligament     reconstruction surgery.   "
191417|NCT00338676|"     Aortic stenosis (AS) is AS is caused by calcium deposits in the aortic valve. Calcification     is progressive and eventually leads to reduced leaflet motion with obstruction of the left     ventricular outflow. The only treatment is surgery. There are evidences that AS is a     regulated process with similarities to atherosclerosis but determinants of AS progression are     unknown. The study aims at evaluating these determinants and more specifically the role of     lipids, inflammation and platelet aggregation.   "
191418|NCT00338689|"     Primary hypothesis to be tested:      Early protein intake predicts infant growth and later risk of childhood obesity.        -  Childhood obesity is a major public health problem and is an identified priority concern          for the health care. Infants fed formula are more likely to become obese than breastfed          infants. The higher protein content of infant formulae, compared with breast milk, could          be a causal factor.        -  The study will in a multicentre intervention trial on newborn infants investigate          whether feeding infant formulae, which differ in their level of milk proteins, can          influence the risk of later childhood obesity. The trial will take place in five          countries with different habitual total protein intakes to increase the range of protein          intakes        -  The investigators will study body composition, hormonal status, protein metabolism and          anthropometric markers of childhood obesity. The whole cohort will be followed up until          age 11 years, to assess the long term impact on the prevalence of obesity.        -  The investigators will explore the impact of consumer (parental) attitudes to, and          perceptions of, different practices of infant feeding in relation to infant behaviour          (satisfaction, crying, sleep duration). This consumer science information will help          improve the understanding of consumer (infants and parents) acceptance of and preference          for foods that contribute to healthy diets.        -  If a relationship between early dietary protein intake and later childhood obesity risk          is confirmed, it offers possibilities for the prevention of obesity, for improving          advice given to parents and for developing nutritionally improved dietary products for          infants.   "
191419|NCT00338702|"     Foot ulcers represent a significant common complication in patients with diabetes. Wound     healing is a challenge. Some wounds do not respond to the best practices in wound care.     Considerable effort has been directed at therapies to improve the rate of healing.      There are a variety of growth factors which have been used to stimulate wound healing. Human     platelets are an autologous source of growth factors which probably can stimulate healing.     Autologous platelet gel (APG) is prepared by centrifugation of autologous human whole blood.     APG is rich in platelet growth factors. This study will investigate the potential improvement     in wound healing with this material in diabetic foot ulcers.      This study will compare the use of autologous platelet gel ( study group) and standard care (     control group) in the treatment of diabetic plantar forefoot ulcers. This study will also     compare the cost and quality of life in the two groups.      Objectives of the study:        -  To determine if topical APG (autologous platelet gel) is beneficial in the treatment of          diabetic foot ulcers.        -  To determine if it will result in a faster rate of wound healing.        -  To determine if it will improve the quality of life in patients with diabetic foot          ulcers.   "
191441|NCT00344630|"     To compare the relative efficacy and safety of the TAXUS Express2 stents and the Cypher     stents among a broad, unselected patient population treated in a nationwide, multi-center     clinical registry representative of 'real-world,' contemporary clinical practice. A secondary     objective is to examine performance of the two stents in pre-specified subgroup populations     and examine regional and national patterns in outcomes.   "
191442|NCT00344643|"     The purpose of this research is to compare the on-eye performance of 12 month daily wear     versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable     contact lenses by studying its effects on human eyes. Usual and customary care will be given     in the form of eyeglasses and/or contact lenses.   "
191443|NCT00344656|"     This study will use functional magnetic resonance imaging to compare appetite-related brain     activity in women with anorexia nervosa before and after receiving treatment for the     disorder.   "
191444|NCT00344669|"     The purpose of the study was to determine whether periodical mass deworming improves growth     in children below six years of age.   "
191420|NCT00338715|"     Atrial fibrillation (AF) is an irregular heart rhythm that occurs in 30% to 40% of patients     following heart surgery. This irregular heart rhythm, although often self-limiting, can be     cause for concern. AF is associated with a two-fold increase in patient complications and     mortality after heart surgery. During AF, the heart muscle does not contract properly causing     the blood flow through the heart to slow down potentially forming clots. A clot may then     enter the blood stream and be carried to the brain, possibly causing a stroke. Patients in     persistent AF require blood thinners to prevent strokes, and this carries its own bleeding     risks especially in elderly patients.      Patients in AF after heart surgery spend twice as many days in the intensive care unit and 3     to 4 more days in the hospital, hence the impact on hospital resources is quite significant.     Various medications are used to prevent AF after heart surgery but they are unable to     completely prevent this complication and the medications have associated side effects. In an     effort to optimize the care of heart surgery patients, strategies set on eliminating the     onset of AF after surgery, as opposed to trying to control AF with less than effective     medications, is a necessity.      We are proposing a study to determine if isolating the misfiring areas that cause AF at the     time of bypass surgery in high-risk patients will decrease the occurrence of AF following     heart surgery. Consenting patients will be randomized to one of two groups. Group 1 will     undergo bypass surgery plus the additional procedure of pulmonary vein isolation and Group 2     will undergo bypass surgery only, without the additional procedure. Four staff cardiac     surgeons at the London Health Sciences Centre will perform all surgeries. Patients will be     seen postoperatively every six months and will be followed for a two-year period. The     occurrence of AF will be recorded as well as other complications and lengths of hospital     stay. We predict that the group with the additional pulmonary vein isolation procedure to     prevent AF will have a much lower occurrence of this complication. If this is found to be     beneficial, this will significantly decrease the complications and mortality associated with     heart surgery. This will have a profound effect in the delivery of care to patients with     coronary artery disease and other forms of heart disease.   "
191421|NCT00338728|"     The goal of this clinical research study is to learn if the combination of Femara (letrozole)     and Gleevec (imatinib mesylate) can shrink or slow the growth of the tumor in patients who     have hormonal sensitive advanced breast cancer.      Primary Objectives:        -  To determine the efficacy of Letrozole plus Imatinib Mesylate in patients with ER and or          PgR positive metastatic breast cancer. Efficacy will be measured by the rate of clinical          tumor response.        -  To determine the safety and tolerability of Letrozole plus Imatinib Mesylate in patients          with metastatic breast cancer.        -  To determine the time to disease progression and overall survival in patients with          metastatic breast cancer who are treated with Letrozole plus Imatinib Mesylate.   "
191422|NCT00338741|"     The objective for establishing the Rebif® Pregnancy Registry is to collect prospective     outcomes data on women in the United States and Canada who have been exposed to Rebif® during     their pregnancies. The primary end point will be the rate of spontaneous abortions in exposed     pregnancies. This rate will be compared with the rate of spontaneous abortions in patients     with Multiple Sclerosis (MS) whose pregnancies were not exposed to any interferon-beta in a     manner consistent with the FDA August 2002 Guidance for Industry: Establishing Pregnancy     Exposure Registries   "
191423|NCT00338754|"     The purpose of the study is to assess the efficacy and safety of repeated administration of     adalimumab in adult Japanese subjects with moderate to severe chronic plaque psoriasis.   "
191424|NCT00338767|"     This study will evaluate the effectiveness of directly observed therapy plus antidepressant     medication in improving adherence to antiretroviral drug therapy among HIV-infected homeless     and marginally housed people with depression.   "
191425|NCT00338780|"     The aim is to investigate whether Lamivudine 100mg daily is effective in the long term     treatment of HBeAg negative chronic HBV infected patients with active liver disease in Asia   "
191426|NCT00338793|"     Tuberculous pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids     are used for tuberculous pleurisy because their anti-inflammatory effect is thought to     minimise pleural reactivity and thereby reduce residual pleural thickening. The purpose is to     evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with     tuberculous pleurisy.   "
191427|NCT00338806|"     This study will develop strategies for early detection and prevention of mood disorders and     associated impairment in adolescent children of parents with bipolar disorder.   "
191428|NCT00338819|"     Purpose:      To test the hemodynamic profile generated by the MCS’s ActiveCare+SFT device in ventilated     patients and compare it to that of the Kendall SCD Express.      Design:      Comparative, prospective study. Patients are their own controls.   "
191429|NCT00338832|"     This study will evaluate the effectiveness of a lifestyle intervention in increasing physical     activity and reducing disease symptoms in sedentary adults with schizophrenia.   "
191430|NCT00338845|"     This study will evaluate the effectiveness of the Share Safer Sex Program in reducing sexual     risk behaviors among female sex workers in four Mexican cities close to the U.S. border.   "
191431|NCT00338858|"     The purpose of this study is to explore the connection between gait variability parameters     and balance performance in children with physical disability   "
191432|NCT00338871|"     The purpose of this study is to examine whether simple home-base aerobic exercise program     have beneficial effect on walking abilities and balance performance in children with brain     damage   "
191433|NCT00338884|"     A phase II study to allow patients with advanced kidney cancer access to sunitinib malate     treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a     continuous daily regimen (once per day) for one year.   "
191434|NCT00338897|"     The primary objective is to:        -  demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE)          by the demonstration of a dose-response in patients undergoing total hip replacement          surgery.      The secondary objectives are to:        -  evaluate the safety of SR123781A in the prevention of VTE after elective total hip          replacement surgery; and        -  to assess the SR123781A pharmacokinetic profile in patients undergoing elective total          hip replacement surgery.   "
191435|NCT00338910|"     The primary objective of this study is to describe a possible effect of metronidazole on PK     of budesonide in healthy volunteers.   "
191436|NCT00338923|"     This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic     neuropathic plantar and venous ulcers.      HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration     and differentiation at the wound area.        -  The primary end point of this study is assessment of safety in treating with HO/03/03          and the efficacy of the drug to promote wound closure of chronic wounds.        -  The secondary end points are assessment time to closure and healing rate for the          measurement of wound healing progression.   "
191437|NCT00338936|"     This study is designed to provide long-term safety and efficacy data for the combination     doses of VAH (VAL/ HCTZ) 40/6.25mg and 80/12.5mg in essential hypertensive patients. The 350     patients (approximately) who have successfully finished the core trial CVAH631B1303 and     signed consent for the extension will be enrolled into this study.   "
191446|NCT00344695|"     The purpose of this study is to 1) evaluate the safety and efficacy of two doses of bupropion     SR (150mg/day and 300mg/day) when compared to placebo, as an aid to smoking cessation in     adolescents and 2) to examine which factors, such as medication adherence, nicotine     dependence, and motivation to quit, affect treatment outcome.   "
191447|NCT00344708|"     To investigate the effect of using tissue cultured human amniotic epithelial cells to     re-establish severely damaged ocular surfaces. Specifically, to determine the efficacy of     transplanted tissue cultured amniotic epithelial cells on persistent corneal epithelial     defect, a potential visual threaten ocular disorder.   "
191448|NCT00344721|"     To determine the effect of Essential Fatty Acids (EFA’s) on Meibomian Gland lipids and     aqueous tear production in patients with “dry eyes”.   "
191449|NCT00344734|"     The study tests the hypothesis that nitric oxide availability is changed in congestive heart     failure with regard to the regulation of renal hemodynamics, renal sodium excretion and     release of vasoactive hormones. The study tests these hypotheses by comparing the effects of     systemic nitric oxide inhibition with L-NMMA in congestive heart failure patients with     healthy subjects on renal hemodynamics, blood pressure and plasma levels of vasoactive     hormones.   "
191450|NCT00344747|"     Obesity has become a pandemic, and it is today's principal neglected public health problem.      Obesity has increased dramatically during the past two decades At adolescence, it is an     aggravating issue, because obesity tends to persist in adulthood and the longer its duration,     the higher the associated mortality and morbidity. Obesity imposes a heavy health and social     burden, and it is widely recognized that treatment is costly. If obesity is not successfully     addressed by late adolescence, the likelihood of weight loss in adulthood is as low as 5%.     Therefore, prevention is crucial, and children and adolescents should be a priority target.      Treatment of obesity is costly, time consuming, difficult and the results aren't always     satisfying On most cases the patients receive dietary advice only (6-10 visits per year). And     usually the patients end the treatment early due to lack of results.      The best treatment of children and adolescent obesity is done in highly specialized settings,     by a multidisciplinary team. Those programs have a limited number of locations (not always in     proximity to the patients' residence), in addition, they are long term treatments and     therefore are hard to complete successfully without additional support, Therefore only a     limited number of patients can benefit from such programs.      Due to the reasons mentioned above, many families tend not to start the process of treating     their obese child, or turn to commercial weight loss programs, or put their children     according to their beliefs and diets.      Therefore ambulatory medicine is the ideal setting for the treatment of children and     adolescent's obesity, it's also in proximity to the patients' residence, the medical team has     a deep knowing of their patients and the possibility for long term maintenance and follow-up.      We propose a trial of obesity treatment by behavior modification program, including parents     as agents of change.   "
191451|NCT00344760|"     We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction     phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower     number of minority variant HIV-1 strains.   "
191452|NCT00344773|"     The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of     Gefitinib.   "
191453|NCT00344786|"     CLL dosing escalating study; daily dosing schedule; PK/PD safety   "
191454|NCT00344799|"     Patients who are diagnosed with choroidal melanoma and undergo I-125 plaque or enucleation     surgery consent to participate in the study. A tumor sample taken during surgery is studied     in the lab for genetic features. These features and features of subjects' clinical course are     recorded. Analysis of the data may identify genetic features that are indicative of     prognostic factors including risk of metastasis.   "
191455|NCT00344812|"     A 17 week, double-blind, randomized, parallel group, four arm design outpatient study     comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid     dependence.   "
191456|NCT00344825|"     300 patients, starting a new pharmacological treatment for B-CLL, were enrolled by 36 Italian     Centres for assessing the Quality of Life (QoL). A descriptive analysis of QoL and the     correlation of the age, sex, stage of disease, Time from first B-CLL diagnosis, Number of     previous B-CLL treatments, reason of starting of the new B-CLL treatment: therapeutic     Regimen, type of Centre, B-CLL treatment lasting, response to B-CLL treatment.   "
191457|NCT00344838|"     To compare the results of two commercially available customized laser ablation devices.   "
191458|NCT00344851|"     Current research has shown that the use of diabetes management practices aimed at reducing     insulin resistance and hyperinsulinemia (such as weight reduction and the administration of     oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism     but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine     called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal     glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to     extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on     menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women     with PCOS.   "
191459|NCT00344864|"     High order aberrations (HOA) are visual phenomena that decrease quality of vision. Examples     of high order aberration are glare, halos, decreased contrast sensitivity and shape     distortion. They are caused by slight imperfections or distortions in the corneal surface.     HOA are currently measured using a variety of FDA approved devices. For this study, the     LADARWave (Alcon) will be used to measure HOA. This device uses a harmless beam of light. It     is FDA approved and non-invasive. Contact lens induced high order aberrations have never been     measured and reported in the literature. This work may provide information to guide future     contact lens design.   "
191475|NCT00345072|"     The purpose of this study is to develop and test a web-based system intended to help women     going through menopause make more informed choices regarding menopause treatments. The system     will do this by giving women personalized feedback on the risks and benefits of these     treatments.   "
191476|NCT00345085|"     This project involves evaluation of post operative contrast sensitivity and wavefront     aberration results among patients implanted with standard monofocal lenses (Acrysof     SN60AT/SN60WF) and the new presbyopic correcting multifocal lens (Acrysof ReSTOR). Higher     Order aberrations are visual phenomena such as glare and haloes. They are more prevalent     after cataract surgery and can affect night driving.   "
191477|NCT00345098|"     The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of     depressive symptoms in patients with major depressive disorder. Relapse will be assessed     using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end     of the initial 12-week open-label treatment period with SR58611A are randomized to continue     SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional     treatment. The secondary objective is to evaluate the safety of SR58611A in patients with     MDD.   "
191478|NCT00345111|"     The objective of the research on the Restore Intra Ocular Lens Implant (IOL) is to determine     the clinical visual outcomes following bilateral implantation of the IOL compared to a     control IOL and to demonstrate what percentage of the subjects obtain spectacle freedom.   "
191479|NCT00345124|"     The aim of the study is to test the following hypotheses:        -  that the function and/or regulation of AQP2 and/or ENaC in the principal cells is          abnormal in essential hypertension.        -  if an abnormal function of the principal cells is present in essential hypertension,          this will become more pronounced at high and low sodium intake.   "
191480|NCT00345137|"     The study tests the hypothesis that systemic and renal nitric oxide availability is changed     in polycystic kidney disease and chronic glomerulonephritis.   "
191481|NCT00345150|"     The study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in     essential hypertension by investigating the effects of a non selective nitric oxide inhibitor     on renal hemodynamics and sodium excretion in patients with essential hypertension. The     results are compared with a group of healthy subjects.   "
191460|NCT00344877|"     OBJECTIVES:      About 15% of patients suffering from focal epilepsy are refractory to available     pharmacological treatments. Until now, the only hope for such patients has been the     development of new pharmaceutical treatments or epilepsy surgery. In case of inoperability,     different types of invasive brain stimulation such as vagus nerve stimulation or deep brain     stimulation or non-invasive repetitive TMS have been evaluated to determine their     anticonvulsive potential. For rTMS, weak and short lasting seizure reduction has been     reported in different epilepsy syndromes.      A new, non-invasive stimulation technique, transcranial direct current stimulation (tDCS),     was useful to modulate cortical excitability in many cortical areas (M1, visual cortex,     frontal cortex). Cathodal tDCS, with a current of 1 mA, induced long-term depression in     animal models and reportedly decreased the excitability of both human and animal cerebral     cortex. In epilepsy patients suffering from a malformation of cortical development, a single     session of cathodal tDCS helped reduce seizures briefly. The purpose of this protocol is to     study the effects of repeated applications of tDCS on the excitability of the seizure focus     in patients with poorly controlled pharmacologically refractory temporal lobe epilepsy.      STUDY POPULATION:      We plan to study 56 patients between the ages of 18 and 80 suffering from temporal lobe     epilepsy.      DESIGN:      Subjects will be allocated by blocked randomization to one of two groups (parallel design).     Group A will receive cathodal tDCS and group B will receive Sham-tDCS on five consecutive     days. Each subject will participate in 9 sessions (1 baseline visit, 5 intervention visits, 3     follow-up visits). The effect of the intervention relative to the sham stimulation will be     evaluated by comparing seizure frequency and neuropsychological tests during the 8 weeks     before and after the intervention.      OUTCOME MEASURES:      Primary outcome measure will be the mean seizure frequency per 4 weeks in the tDCS group as     compared to the Sham-tDCS group. To analyze the effect of the intervention (tDCS), seizures     will be evaluated during a 2x4 week baseline period before tDCS and 2x4 weeks after the     intervention. Using these data we will calculate the percentage change of seizures per 4     weeks.      Secondary outcome measures will be the scores of the neuropsychological testing (HVLT-R,     BVMT-R, CTMT, COWAT) and number of epileptiform discharges in the EEG. Furthermore, th...   "
191461|NCT00344890|"     The purpose of this study is to compare the safety and efficacy of Preservon(TM) treated     allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion     of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or     myelopathy.      Patient follow-up will be conducted at 6 weeks, 3 months, and 6 months. At 3 months after     surgery, the implanted bone dowels will be assessed for subsidence; at 6 months after     surgery, the implanted bone dowels will be assessed for fusion. Patients will complete     questionnaires and x-rays taken at each visit.      The degree of subsidence and rate of fusion will be assessed based on the evaluation of the     x-rays taken. The x-ray evaluation will be conducted by a neurosurgeon who is blinded to the     type of treatment that each patient has received.   "
191462|NCT00344903|"     The Dallas Heart Study (DHS-1) is a large, multi-ethnic, population-based epidemiological     study designed to identify determinants of atherosclerotic heart disease (ASHD) in a     representative United States (US) urban environment. This study completed enrollment in 2003.      Our objective is to pinpoint factors contributing to progression:        1. from health to ASHD risk;        2. from ASHD risk to subclinical ASHD; and        3. from subclinical to clinical ASHD.      Identification of the critical factors in these transitions will enable targeted     implementation of appropriate therapy to interdict before clinical ASHD develops.   "
191463|NCT00344916|"     Phase 1 study of the effects of nitric oxide inhibition with L-NMMA in patients with liver     cirrhosis and healthy controls. It is hypothesized that nitric oxide availability is     increased in liver cirrhosis.   "
191464|NCT00344929|"     Hypothesis A “multifaceted” intervention program aimed at increasing the responsiveness of     care givers, the adequacy of care provided, and the efficacy of organisation of care, in     presence of abnormal blood loss in the immediate post partum has more impact on the incidence     of severe PPH and on the costs of care than the current methods of dissemination of clinical     practice guidelines.      Intervention Intervention group. The intervention includes three components: (1) outreach     visits with local presentation of evidence-based clinical practice guidelines for management     of PPH, and discussion of their applicability in the context of local organisation; (2)     during these educational visits, reminders - check list, “PPH emergency case” containing     appropriate materials – to be used in case of PPH, will be proposed; (3) finally, cases of     severe PPH will be reviewed during peer review sessions organized in each participating unit,     to help identifying weaknesses in care provided, and needs for improvement.      Control group. The proposed guidelines for management of PPH will be disseminated through the     participating perinatal networks; then each unit will be free to implement them at its own     convenience.      Randomisation procedure The trial follows a cluster randomised trial design. Randomisation of     maternity units will be stratified by region, status (public versus private) and size (annual     number of deliveries). The stratified design will guarantee the comparability of the two arms     of the trial at baseline.      Outcome measures The primary outcome is the incidence of severe PPH (number of severe PPH to     number of deliveries). A severe PPH is defined as a PPH that was associated with one or more     of the following: peripartum haemoglobin drop greater than 4g/dl, blood transfusion, arterial     embolisation, surgical procedures such as hysterectomy or arterial ligation, transfer of the     mother to intensive care unit, maternal death.      Secondary outcomes include the cost of care and the cost/efficacy ratio, and the incidence of     adverse effects of uterotonic drugs.   "
191465|NCT00344942|"     To demonstrate the superiority of the clinical efficacy of 12 weeks' treatment with Nasacort     versus placebo in adult patients presenting with Chronic Non Allergic and Non Infectious     Rhinitis   "
191466|NCT00344955|"     We wanted to test the acute effect of HMG-CoA reductase inhibition (atorvastatin) on renal     hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.   "
191467|NCT00344968|"     This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone     acetonide for the treatment of diabetic macular edema.   "
191468|NCT00344981|"     Study Hypothesis Evaluation of the durability of the combination Tenofovir and Hydroxyurea to     maintain viral suppression below 50 copies/ml in volunteers who have achieved viral     suppression on a standard HAART regimen.   "
191469|NCT00344994|"     The purpose of this study is to determine the equipotent dose of ropinirole and pramipexole     for patients switched from pramipexole to ropinirole in patients with moderate to severe     primary Restless Legs Syndrome (RLS). The rationale behind Switch is that patients with     Restless Legs Syndrome can maintain stable efficacy and tolerability if correctly switched     from one dopamine agonist to an equipotent dose of another.   "
191470|NCT00345007|"     Assess recovery of macula function after successful scleral buckling surgery for     rhegmatogenous retinal detachment by using the multifocal ERG in the postoperative period     i.e. recovery of functional integrity 2. Assess the relationship between the neurosensory     retina and the retinal pigment epithelium/choriocapillaris after scleral buckling i.e.     recovery of structural integrity 3. Assess if there is a difference between macula function     postoperatively, in eyes with retinal detachments involving the macula and those that do not.   "
191471|NCT00345020|"     The research objectives of this study are to determine if small incision Deep Lamellar     Endothelial Keratoplasty (DLEK) is able to further reduce the degree of corneal astigmatism     and shorten the time course of corneal topography stabilization compared to standard full     thickness corneal transplant (PKP) surgery.   "
191472|NCT00345033|"     This study will evaluate the effects of combination treatment with aripiprazole and clozapine     on insulin resistance, blood fat levels, and weight gain in people diagnosed with     schizophrenia.   "
191473|NCT00345046|"     Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.   "
191482|NCT00345163|"     This is a Phase II, open-label, multicenter, randomized, non comparative study consisting of     two concurrent single-arms. Approximately 160 subjects will be randomized in a 1:1 ratio to     Arm 1 (bevacizumab alone) or Arm 2 (bevacizumab + irinotecan).   "
191483|NCT00345176|"     Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant     vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression     to advanced age-related macular degeneration (AMD). Observational data suggest that increased     dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty     acids (docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA]), or both might further     reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA,     or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk     of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta     carotene and reducing zinc dose in the AREDS formulation.   "
191484|NCT00345189|"     This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and     pharmacodynamics study.   "
191485|NCT00345202|"     We wanted to test the shortterm effects of HMG-CoA reductase inhibition (atorvastatin) on     renal hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.   "
191486|NCT00345215|"     The aim of the study is to test the hypothesis that the function and/or regulation of     aquaporin 2 and/or endothelial sodium channels in the principal cells of healthy humans is     abnormal at high and low sodium intake   "
191487|NCT00345228|"     1. To identify the underlying causes of macular haemorrhages in patients with high myopia        2. In the eyes found to have macular haemorrhages secondary to choroidal          neovascularisation, we hope to identify the risk factors for the development of          choroidal neovascularisation in high myopia        3. To study the functional outcome of these eyes as assessed by visual acuity        4. To study the morphological outcome of these eyes by clinical assessment (and fundal          photography) and fluorescein angiography   "
191488|NCT00345241|"     To evaluate tear film stability of a market lubricant therapeutic eye drop versus saline when     using Evaporometry and Interferometry in patients with a diagnosis of Keratoconjunctivitis     Sicca (KCS). The purpose of this research is to evaluate evaporative parameters and tear film     quality when using Systane lubricating eye drops versus saline in the eyes of dry eye     patients at pre-instillation and at 30 and 60 minutes post instillation of drop(s).   "
191489|NCT00345254|"     Umbilical cord often becomes encircled around portions of the fetus, usually the neck. The     incidence ranges from 1 loop in 21% to 3 loops in 0.2%. In this study we wish to assessed the     practice of severing the cord, which was encircled once around the neck of the fetus, after     delivery of the anterior shoulder and prior to extraction of the body. The study and the     control groups will include 30 women, each one. After diagnosis of cord around the neck     during labor by ultrasound, the women will inter a randomization process. After delivery of     the head, it will be cut intentionally in the study group and left intact in the control     group. Neonatal outcome will be assessed.   "
191490|NCT00345267|"     Integrated care pathways (ICP) coalesce medical and nursing work practices, unifying and     directing care in line with current best practice and guidelines. We wish to examine the     introduction of an ICP for children with wheeze/asthma admitted to our hospital. We will     determine whether more rigid, but guided care results in faster recovery, quicker discharge     with better education and fewer prescribing errors, but also determine whether staff feel     alienated by the rigidity of practice, and parents perceive any benefit to the changes     introduced.This will be a cluster randomised trial (random weeks) of standard or ICP care in     180 patients admitted to Sick Kids with wheeze/asthma. Parents will be asked to complete a     questionnaire on admission and contacted at 10-14 days post discharge and asked to recall     education provided at discharge; no other patient or parent intervention will be required.It     is expected to take 40 weeks to recruit 180 patients.   "
191491|NCT00345280|"     Cystic fibrosis(CF) is an inherited disease affecting children, adolescents and young adults     with dysfunction of secretory glands.It is caused by mutations in the protein-coding gene     which function as the cystic fibrosis transmembrane regulator (CFTR), responsible for the     secretion of chloride ions in epithelial cells, adenocytes, sweat gland cells, pancreatic     ducts,alimentary and respiratory tracts and eye. Assessment of the relationship between the     inflammatory processes and apoptosis in the eye in the course of cystic fibrosis will allow     determination of immunological exponents which may facilitate diagnosis.   "
191492|NCT00345293|"     The purpose of this study is to assess the safety and activity of DC/PC3, a dendritic cell     vaccine used as immunotherapy for prostate cancer. The vaccine is made with each     participants' own immune cells obtained through blood donation. Dendritic cells are known to     activate other immune cells such as T cells, that are able to mount an attack against cancer     cells. The dendritic cell vaccine will be administered as injections every 2 weeks over a     course of 2 months.   "
191610|NCT00353041|"     This is a study of the effect of time on the effectiveness of topical anesthetics in the     mouth. The Null Hypothesis is: Regardless of the time of application over a 10-minute period,     there is no difference in the clinical effectiveness of the topical anesthetic 5% lidocaine     on (a) the pain of needle stick insertion and (b) the pain of local anaesthetic     administration.   "
191493|NCT00345306|"     The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a     hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a     hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried     out using estrogen stimulation followed by a concomitant progesterone treatment. Two     progestative drugs are currently used in conventional IVF treatment, Utrogetan and     Endometrin. Although Endometrin has been be efficiently used to support the luteal phase     after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy     for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of     frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative     substitution in an artificially prepared endometrium.   "
191494|NCT00345319|"     Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis     regimen to healthy children and adults aged 10-60 years.   "
191495|NCT00345332|"     The purpose of the study is to determine how effective Botox is in reducing the amount of     urine leaked and which dose of Botox is more effective and safe in those who have urinary     urge incontinence.   "
191496|NCT00345345|"     This study will examine the use of alemtuzumab (Campath ) in patients with T cell large     granular lymphocytic leukemia (T-LGL). Patients with T-LGL often have reduced white blood     cells, red blood cells and platelets, and increased numbers of abnormal cells called large     granular lymphocytes (LGLs). Patients may have recurrent infections, anemia, or abnormal     bleeding. Campath destroys specific parts of the abnormal LGLs, which interfere with the     production of normal blood cells. This study will determine whether Campath can increase     blood counts and reduce the number of abnormal LGLs in patients and will examine the side     effects of the drug.      Patients 18 to 85 years of age with T-LGL leukemia may be eligible for this study.     Participants undergo the following procedures:      Before starting Campath treatment        -  Medical history and physical examination, blood tests, electrocardiogram (ECG).        -  Echocardiogram (heart ultrasound) and 24-hour Holter monitoring (continuous ECG          recording).        -  Bone marrow biopsy: About a tablespoon of bone marrow is withdrawn through a needle          inserted into the hipbone. The procedure is done using local anesthetic.        -  Placement of central line, if needed: An intravenous line (tube) is placed into a major          vein in the chest. It can stay in the body and be used for the entire treatment period.          The line is used to give chemotherapy or other medications, including antibiotics and          blood transfusions, and to collect blood samples. The line is usually placed under local          anesthesia in the radiology department or the operating room.        -  Apheresis: A catheter (plastic tube) is placed in a vein in each arm. Blood is drawn          from one vein and run through a cell-separating machine, where the white blood cells are          collected and saved. The remaining blood is transfused back to the patients through the          vein in the other arm.      During Campath treatment        -  Campath therapy: After a small test dose, patients receive10 daily infusions of Campath          , each of which lasts about 2 hours. The first few infusions are given at the NIH          Clinical Center so that the patient can be monitored closely.        -  Induction therapy: Aerosolized pentamadine, valacyclovir and other medicines are given          to protect against or treat various infections that commonly affect patients with          suppressed immune systems.        -  Whole blood or platelet transfusions, if needed, and injections of growth factors, if          needed.        -  Blood tests and check of vital signs (temperature, pulse, blood pressure) every day          during treatment. Echocardiogram and 24-hour Holter monitor after the last dose of          Campath .      Follow-up evaluations after Campath treatment ends        -  Blood tests at home or at NIH (weekly for the first 3 months, then every other week          until 6 months, then annually for 5 years        -  Echocardiogram at NIH (at 3 months only)        -  Bone marrow biopsy at NIH (at 6 and 12 months, then as clinically indicated)        -  One repeat apheresis collection for laboratory studies.   "
191497|NCT00345358|"     The purpose of this phase IIIb study is to determine whether children who have not received a     3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of     age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity,     safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be     evaluated for four different age groups with different schedules:      < 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age     group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose     vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no     booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib     vaccine.   "
191498|NCT00345371|"     The purpose of this study is to assess the efficacy and safety of topiramate as compared to     placebo in reducing methamphetamine use in subjects with methamphetamine dependence.   "
191499|NCT00345384|"     The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory     stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients     undergoing thoracic surgery after discharge from PACU or ICU.   "
191500|NCT00345397|"     The investigators want to know if placing a tube through the skin and into the colon to flush     out the colon is safe and effective in helping spinal cord Veterans with bowel management.   "
191501|NCT00345410|"     Primary objective: to assess the effect of AVE1625 on weight loss over a period of 24 weeks     in abdominally obese patients with atherogenic dyslipidemia. Secondary objectives: - To     assess the dose effect relationship of AVE1625 on HDL-cholesterol and triglycerides plasma     levels over a period of 24 weeks - To assess the efficacy of AVE1625 on secondary parameters     such as waist circumference and other metabolic parameters over a period of 24 weeks - To     assess the safety and tolerabillity of AVE1625 over a period of 24 weeks.   "
191502|NCT00345436|"     Insulin resistance, often accompanied by obesity, plays a major role in the development of     type 2 diabetes. This phenomenon may be related with the fact that American adolescents are     now becoming less physically active in early puberty, explaining the largely pubertal and     post-pubertal onset of type 2 diabetes in adolescence. Although regular physical activity has     been suggested to attenuate obesity and prevent type 2 diabetes in high-risk children and     adolescents, the magnitude of exercise training-induced improvement in the risk factors for     type 2 diabetes has been only recently studied in adults and studied very little in pediatric     populations. It is clear that exercise, diet, and genetics all contribute to the development     of type 2 diabetes in children. However, the few studies that have been done to dissect the     relative contributions of these three risk factors have generally used only lipid profiles as     the end point. There have been a number of recent advances in our understanding of the     molecular basis of type 2 diabetes, particularly, with regards to insulin regulatory pathways     modulated by exercise within muscle tissue.   "
191513|NCT00345579|"     The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to     a control group receiving licensed Hib conjugate vaccine, when each are co-administered with     Pediarix® to healthy infants at 2, 4, and 6 months of age.      This protocol posting deals with objectives & outcome measures of the primary phase of the     study. The objectives & outcome measures of the Booster phase are presented in a separate     protocol posting (NCT number = 00345683).      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007   "
191514|NCT00345592|"     Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and     fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and     to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared     to an in-hospital approach for treatment of symptomatic AT/AF.   "
191515|NCT00345605|"     Urea cycle disorders are inherited illnesses in which the body does not produce enough of the     chemicals that remove ammonia, a byproduct of protein metabolism, from the blood stream.     Elevated ammonia levels can lead to brain damage and death. Argininosuccinic aciduria (ASA)     is a type of urea cycle disorder that is characterized specifically by high levels of     argininosuccinic acid, a chemical involved in the urea cycle. People with ASA are at risk for     serious liver damage, which may be due to the elevated levels of argininosuccinic acid.     Sodium phenylbutyrate (Buphenyl-TM) is a drug that has been used to treat other types of urea     cycle disorders. This study will evaluate whether Buphenyl-TM in conjunction with decreased     arginine dose (in addition to a normal regimen of protein) will improve short-term liver     function and decrease plasma citrulline and ASA levels in people with ASA.   "
191516|NCT00345618|"     Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as     effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic     events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic     deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.   "
191503|NCT00345449|"     In 2006, the International Patient Decision Aids Collaboration (IPDAS) reached agreement on     criteria for evaluation. Accordingly, the primary outcome is 'decision quality' 3 weeks after     using the decision aid. Decision quality is defined as the extent to which a patient decision     aid improves the match between the chosen option and the features that matter most to the     informed patient. Measures include: a) patients' knowledge of essential facts [options,     benefits, harms, and outcome probabilities]; and b. the congruence between the option chosen     and patients' informed values regarding benefits and risks.      In the past twenty years lung transplantation has become the most widely accepted option of     treating cystic fibrosis patients with severe lung disease. Lung transplantation can be a     good experience for many patients, improving their quality of life and their survival.     However there are potential risks of lung transplantation including infection, organ     rejection and early death. Cystic fibrosis patients are often faced with making a choice of     whether to be referred for lung transplantation when they are very sick and there is the     immediate need to survive. Our group has developed a tool called a decision aid which we hope     will assist the patient and family in making this choice. The decision aid guides the patient     through a series of steps where they weigh the benefits and risks of being referred for lung     transplantation and the benefits and risks of receiving 'usual care' without the option of     referral.   "
191504|NCT00345462|"     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of     these vaccines are required to be involved in ongoing clinical trials and to present the     results to the competent authorities each year. The current study is a phase IIIa clinical     trial with a commercially available virosomal vaccine (Invivac®) supplied in pre filled     syringes. It is part of the ongoing clinical trial program for Invivac® and will be done to     assess the immunogenicity and safety and tolerability of next season's trivalent influenza     virosomal vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and     subjects >= 61 years of age (elderly).   "
191505|NCT00345475|"     This is a prospective, observational, exposure-registration and follow-up study of women and     their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception     (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The     UCB AED Pregnancy Registry is designed to monitor pregnancies exposed to Keppra® and Keppra     XR® in order to determine if there is a potential increase in the risk of major birth defects     compared to rates from women in the general US population.      The objectives of the UCB AED Pregnancy Registry are:        -  To prospectively collect data concerning 1) exposure to Keppra® and Keppra XR® during          pregnancy, 2) potential confounding factors, 3) outcome of pregnancy, and 4) long-term          pediatric outcome        -  To review reported cases of possible birth defects        -  To estimate the risk of birth defects occurring in live-born offspring of women exposed          to Keppra® and Keppra XR® during pregnancy      This study is being conducted in the United States (US). Enrollment in the Registry is     voluntary. The UCB AED Pregnancy Registry is sponsored by UCB, Inc. and is managed by INC     Research. The scientific conduct and analysis of the Registry is overseen by an Expert Panel     consisting of external specialists in teratology/genetics, epidemiology, maternal and fetal     medicine, and neurology (external member details available upon request).   "
191506|NCT00345488|"     The study examines time spent in the emergency room on admission of patients with hip     fracture in a cohort with a traditional setup compared with a prospective cohort with a fast     track admission schedule including nurse initiation of treatmnet, standardized analgesia,     fluid and oxygen therapy and standardized logistics for x-ray and admission procedures.   "
191507|NCT00345501|"     The prevention of contrast-mediated nephropathy (CMN), which accounts for considerable     morbidity and mortality, remains a vexing problem. Contrast induced renal vasoconstriction is     believed to play a pivotal role in the CMN mechanism. The aim of this study is to examine the     efficacy of the prostacyclin analogue iloprost (dose 1ng/kg/min) in preventing CMN in     high-risk patients undergoing a coronary procedure.   "
191508|NCT00345514|"     The purpose of this study is to examine the interaction between the personal attributes of     clinicians and the organizations in which they work and the effect of interventions on their     ability to implement an asthma disease management program. +   "
191509|NCT00345527|"     Despite evidence of high rates of concurrent substance use and anger problems among problem     gamblers, until recently there have been no empirically evaluated treatments for these     co-morbid problems. A recent study (Korman, Collins, McMain, & Skinner, 2005) found that an     emotion and behaviour regulation treatment (EBRT) was more effective than a gambling-only     treatment-as-usual in engaging clients in treatment and in reducing gambling, anger, and     substance use. This study is a replication of Korman et al's study and will compare an     emotion and behaviour regulation treatment (EBRT) for problem gambling, anger and substance     use to a manualized cognitive behavioural treatment (CBT) for problem gambling.   "
191510|NCT00345540|"     The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin     in a cohort of women with platinum resistant cancer of ovarian origin.   "
191511|NCT00345553|"     Little is known about the factors that cause biliary atresia nor the factors that influence     disease progression. The purpose of this study is to collect the pertinent clinical     information, genetic material and body fluid samples to enable investigators to address the     following aims: To identify the gene or genes implicated in the etiology of BA; To identify     polymorphisms that may be important in disease progression such as HLA polymorphisms; To     characterize the natural history of the older, non-transplanted child with BA.   "
191512|NCT00345566|"     The protein composition of nutrition may affect the rate of gastric emptying and gastric     fysiology. This is espesially important in children with neurologic impariment, who commonly     rely on tube feedings, have feeding problems, nausea, vomiting, gastroesophageal reflux and     delayed gastric emptying. We aim to find out whether 4 different protein sources affect the     rate of gastric emptying and electrofysiology in this group of children.   "
191608|NCT00353015|"     Primary Objective:      1. Assess the clinical activity defined by response rate of irinotecan and cisplatin in     untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the     gastrointestinal tract.      Secondary Objective:      1. To assess the safety profile of irinotecan and cisplatin in untreated patients with     metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract.   "
191517|NCT00351598|"     The main aim is to determine, in patients with locoregional, non-small cell lung cancer     (NSCLC) treated by definitive radiotherapy, the influence on survival of the volume of     primary tumour, as measured from CT imaging, after adjusting for the effect of the current     TNM staging system and other known prognostic factors (especially ECOG performance and weight     loss).   "
191518|NCT00351611|"     Patients with partial seizures currently taking 1-3 antiepileptic medications will have a     50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to     their current medications for 3 months. Neither the study doctor nor the patient will know     the medication assignment. Vision testing will be performed prior to receiving the study     treatment and at the end of the study to see if there are any changes.   "
191519|NCT00351624|"     The primary objective of this study is to determine whether a 4-month period of     supplementation with 400 mg/day of docosahexaenoic acid (DHA) provided from chewable softgel     capsules containing bubblegum flavored microalgal oil (DHASCO-S) versus placebo improves one     or more cognitive measures of attention, memory, processing speed, and error rate in healthy     children 4 years of age.      The secondary objectives are to measure the safety and tolerability of the DHA dose     administered and to measure blood DHA levels before and after supplementation.   "
191520|NCT00351637|"     The purpose of this Phase II study is to determine the feasibility of the dose titration and     assessment protocol in the impatient population, in the clinical setting of preventing or     managing breakthrough pain, before conducting an appropriately powered phase III study. Thus     the primary purpose of this study is to determine the proportion of patients who are     successfully titrated to an effective dose of sublingual methadone.   "
191521|NCT00351650|"     This study will test dihydrotetrabenazine, or 11C-DTBZ, a radioactive tracer, as an imaging     agent in positron emission tomography (PET). That tracer may have the ability to     noninvasively measure beta cell, that is, -cell mass (BCM) in humans. For researchers hoping     to develop new treatments for diabetes mellitus, a method of measuring BCM is very important.     In this study, researchers will determine if patients with Type 1 diabetes mellitus, who have     almost no BCM, have much less pancreatic uptake of the tracer than do patients without     diabetes. Patients ages 18 and older may be eligible for this study. Three groups will be     studied: Participants who have Type 1 diabetes, those without diabetes, and those who have     been successfully treated with a transplant of the pancreas or pancreas and kidney      The study involves three sets of tests that can be done as an outpatient or after being     admitted to the hospital. Patients will undergo a medical history and procedures including     collection of blood (about 4 teaspoons), pregnancy test for women of childbearing age,     magnetic resonance imaging (MRI) scan, PET scan, and tests involving arginine and glucose.     Arginine is a substance that stimulates insulin release from the -cells. During the     procedure, two intravenous (IV) lines are placed into the arms, one to administer arginine     and the other to draw blood (about eight samples during 10 minutes). For the glucose test,     patients will drink a solution of dextrose, a sugar, and blood samples will be taken over 2     hours from the IV lines. Some patients experience nausea after drinking the solution. Within     48 hours of either test or both, patients will be placed in the PET scan machine and given an     injection of the radioactive material through an IV line. Blood samples of about one-half     teaspoon will be drawn before the procedure starts and again every 10 seconds for the first 2     minutes and at several intervals, up to 60 minutes. Finally, patients will also an MRI scan,     30 to 60 minutes long, of the abdomen. This test will be down within two weeks of the PET     scan. MRI uses a strong magnetic field and radio waves to obtain images of body organs and     tissues. During the scan, patients will be asked to lie still on a table that slides into the     tunnel of the scanner. They will be given earplugs, for the machine can be noisy. Patients     who have metal within their body that is not compatible with the MRI machine will be     withdrawn from the study.   "
191522|NCT00351663|"     The purpose of this study is to evaluate the efficacy of 3 different dosing regimens of     enoxaparin in achieving adequate antithrombotic aFXa levels in critically ill patients.      The relationship between appearance of DVT and antithrombotic aFXa levels will also be     assessed and risk factors associated with inadequate aFXa levels under standard enoxaparin     dosages will be searched for.   "
191523|NCT00351676|"     We, the researchers, propose to link a clinical pharmacist with an internal medicine or     family medicine team to provide pharmaceutical care to all patients assigned to the team. The     hypothesis is that through this team based approach, pharmacists will act as a resource for     providing pharmacotherapeutic advice during the drug therapy decision making process and     promote optimal drug use by identifying and resolving actual and potential drug related     problems. This study is designed to test this hypothesis, by assessing the impact of this     intervention on evidence based, quality of drug therapy indicators, for patients admitted     with heart failure (HF), chronic obstructive pulmonary disease (COPD), community acquired     pneumonia (CAP), type 2 diabetes mellitus (T2DM), and stable coronary artery disease (CAD).   "
191524|NCT00351689|"     A probiotic bacterial strain was tested in a randomized, double blind , placebo controlled     clinical trial with 54 healthy male volunteers. Half the volunteers received the dietary     supplement the other half placebo during 6 weeks prior to exposure to solar-simulated UV     irradition (2x1,5MED). Blister roofs and skin biopsies were recovered 1, 4 and 10 days after     UV exposure from unirradiated and irradiated skin and used for immunohistochemical analysis     and mixed epidermal cell lymphocyte reaction   "
191554|NCT00352313|"     RATIONALE: ATN-161 may stop the growth of tumor cells by blocking blood flow to the tumor.     Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving ATN-161     together with carboplatin may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of ATN-161 when     given together with carboplatin and to see how well they work in treating patients with     recurrent malignant glioma.   "
191525|NCT00351702|"     Title: Evaluation of efficacy of two different preventive therapy regimens for tuberculosis     in HIV infected persons      Phase: Phase III trial      Population: 650 HIV positive patients without tuberculosis      Number of sites: Three        1. Tuberculosis Research centre, Chennai        2. Government General Hospital, Chennai        3. Government Rajaji Hospital, Madurai      Study Duration: 36 months      Study Objectives: To compare the efficacy of two TB preventive therapy regimens in reducing     the incidence of tuberculosis and mortality among HIV-infected persons      Study Design:      The study will be a two-armed prospective randomized clinical trial among HIV- positive     patients without active tuberculosis. Enrolled patients will be assigned to one of the two     unsupervised self-administered treatment regimens i.e. EH for 6 months or INH alone for 3     years. At the end of a 3-year follow-up, incidence of TB and overall mortality will be     compared in each group.      Study Endpoints:The primary end point of the study will be development of tuberculosis and     the secondary endpoints will include adverse drug reactions and mortality rate.   "
191658|NCT00353691|"     To compare the change in glycemic control from baseline to endpoint (last available     posttreatment assessment) as measured by HbA1c in pediatric subjects with type 2 diabetes     receiving either glimepiride or metformin as monotherapy.   "
191526|NCT00351715|"     The purpose of this Phase II study is to determine the feasibility of the dose titration and     assessment protocol in the outpatient population before conducting an appropriately powered     phase III study. Thus the primary purpose of this study is to determine the proportion of     patients who are successfully titrated to an optimal dose of sublingual (Under the tongue)     methadone and then studied at that optimal dose with successive episodes of breakthrough     pain.   "
191527|NCT00351728|"     Patients diagnosed with ocular melanoma consent to participate in the study. Combined PET/CT     scans of the whole body are performed at baseline, three months later, and six months after     that for a total of three combined scans in the first year. Subsequently, these combined     scans will be performed at 6-monthly intervals for a total of two combined scans per year.   "
191528|NCT00351741|"     The purpose of this study is to compare High Frequency Pressure Ventilation (HFPV) to     conventional mechanical ventilation.      Hypothesis: Patients placed on HFPV will have significantly higher number of ventilator-free     days compared to patients placed on a conventional volume mode.   "
191529|NCT00351754|"     To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector     CTA   "
191530|NCT00351767|"     This is a Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety     and efficacy of three different doses of topically applied telbermin in subjects ≥ 18 years     old with diabetic foot ulcers. Approximately 160 adult subjects with Type 1 or Type 2     diabetes mellitus will be enrolled at approximately 40 investigational sites in the United     States and Canada.   "
191531|NCT00351780|"     Study purpose: To evaluate fractional flow reserve-guided side branch intervention strategy     Method: Provisional side branch intervention if jailed side branch FFR<0.75   "
191532|NCT00351793|"     The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized     Total Knee Replacement.   "
191533|NCT00351806|"     The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able     to improve the outcome of acute ischemic stroke and to observe its safety.   "
191534|NCT00351819|"     Naturally occurring opiates (endorphins) decrease testosterone levels by inhibiting the     synthesis of gonadotropin releasing hormone (GnRH) and also inhibiting testosterone synthesis     by the testes. Similarly, men with addiction to narcotics and those on exogenous opioids for     pain control have decreased serum testosterone levels. Indeed, these men complain of     decreased libido, erectile dysfunction and impaired quality of life. Animal studies have     shown that gonadectomy results in a decrease in pain threshold in rats and repletion of     testosterone elevates that threshold. These observations suggest that testosterone may     possess analgesic properties. Hence, the investigators hypothesize that hypogonadism     developing in men on opioids results in an increased sensitivity to pain and requirement of     higher doses of opioids. In this study, the investigators plan to administer testosterone to     men with opioid-induced hypogonadism and evaluate their pain perception, pain sensitivity in     response to noxious stimuli and changes in the requirement of opioids in response to     testosterone administration.      Hypothesis:      Testosterone replacement in men with opioid-induced hypogonadism will improve pain tolerance,     pain perception and quality of life.      Specific aims:        1. To evaluate the effects of testosterone replacement on pain sensitivity, pain tolerance,          and pain modulation in men with opioid-induced hypogonadism.        2. To determine the effects of testosterone replacement on health-related quality of life.        3. To determine whether testosterone replacement in hypogonadal men induces changes in the          dosage requirements of opioid medications for pain control.      To accomplish our specific aims, the investigators propose a randomized, double blind,     placebo-controlled, parallel arm study in which hypogonadal men with non-cancer chronic back     pain syndrome on chronic opioids and low testosterone levels (<300 ng/dl) will be randomized     to exogenous testosterone replacement therapy vs placebo. Our primary outcome is change in     pain tolerance using various external painful stimuli. Secondary outcomes are change in pain     sensitivity and modulation, quality of life and opioid requirements.   "
191535|NCT00351832|"     This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic     agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg     bid or 100mg qd compared to placebo in patients with type 2 diabetes.   "
191536|NCT00351845|"     The purpose of this study is to test the effects of a modified carbohydrate diet versus a     portion controlled diet in overweight or obese men and women on body weight.   "
191537|NCT00351858|"     The purpose of this study is to determine the safety and efficacy of the investigational     trifunctional anti-Her-2/neu x anti-CD3 antibody ertumaxomab as treatment for hormone therapy     refractory Her-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer   "
191538|NCT00351871|"     The objective of this study is to better understand the influence of insulin resistance upon     treatment response in hepatitis C virus treated with PEG Intron and Rebetol.   "
191539|NCT00351884|"     Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy     on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in     patients with type 2 diabetes inadequately controlled with metformin.   "
191540|NCT00351897|"     The purpose of this study is to determine whether Pulsed Dye Laser therapy are effective in     the treatment of Cutaneous Dermatophytosis.   "
191541|NCT00351910|"     To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in     combination with an antidepressant versus an antidepressant alone in patients with Major     Depressive Disorder.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
191542|NCT00351923|"     This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered     subcutaneously or using an alternative administration route.   "
191543|NCT00352157|"     The purpose of this study is to determine if dietary consumption of Revival Soy can improve     the appearance of the skin, hair, and finger nails and support weight loss in overweight,     premenopausal women.   "
191604|NCT00352963|"     This study will evaluate the immunogenicity of the co-administration of different     combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.   "
191544|NCT00352170|"     This study is designed to test whether calcium supplementation alone or calcium plus vitamin     D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts     bone loss in a population-based sample of women 55+ years of age.        -  A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of          spine and appendicular fractures over four years for independently living, rural women          55 years of age and older compared to similar women on their usual diets.        -  A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the          cumulative incidence of spine and appendicular fractures compared to a calcium          supplement only.   "
191659|NCT00353704|"     The purpose of this study is to determine whether the use of oral pregabalin 150 mg as     premedication reduces the amount and degree of postoperative pain.      Furthermore the purpose of this study is to determine whether the use of oral pregabalin 150     mg as premedication reduces anxiety prior to anaesthesia in these patients.   "
191545|NCT00352183|"     Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both     hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary     mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall     objective of the study is to evaluate the efficacy and safety of combining fenofibrate and     simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.   "
191546|NCT00352196|"     This study will be an open-label, 12-week trial of risperidone in subjects with Asperger's     Disorder, according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV)     Criteria. The study has two arms, one involving pre- and post-treatment MRS studies, and one     without MRS. The MRS arm will study 18-20 subjects ages 6 and above, with a target of 14     completing patients. For both arms, we plan to a enroll at total of 30 patients to achieve     completion for 24 patients. The non-MRS arm of the study will include subjects 6-18 years of     age, the bulk of which have completed the study as of the writing of this updated revision.     Our hypotheses are that treatment of Asperger's patients with a low dose of risperidone will:        1. decrease ratios of N-acetylaspartate (NAA), creatine, phosphocreatine (Cr + PCr), and          choline in the prefrontal lobe, and        2. decrease the severity of negative symptoms and overall improve social behavior, and        3. that the two will be correlated.      Specific Aims      The primary objectives of this trial are to:        -  Further assess and investigate the utility of risperidone in the treatment Asperger's          disorder.        -  Assess the efficacy of risperidone in normalizing increased frontal lobe metabolites.        -  Assess the efficacy of risperidone in normalizing symptoms in Asperger's disorder          patients using standardized rating scales to assess the impact on negative symptoms and          on social interaction.        -  Determine whether risperidone's effect on clinical improvement of Asperger's disorder,          i.e., negative symptoms, is correlated with normalization of frontal lobe metabolites        -  Accrue safety and tolerability data on risperidone for this population of patients.      This information could potentially be used to provide pilot data for a double blind trial   "
191547|NCT00352209|"     This study will examine the incidence of cardiac complications, particularly cardiomyopathy,     in patients who have undergone allogeneic (donor) stem cell transplantation at NIH. Cardiac     complications in these patients are well documented. Most commonly, patients develop     congestive heart failure or pericarditis after receiving high-dose cyclophosphamide,     radiation, or other intensive chemotherapy regimens prior to the transplant.      Most data in the medical literature suggest that the rate of serious cardiac complications is     relatively low, at about 5 percent or less. Recently, a cluster of cases of significant     cardiomyopathy in stem cell transplant patients at the NIH Clinical Center has prompted     concern that the incidence of these complications is higher than that reported in the medical     literature.      This study will further define the incidence of cardiac problems, primarily focusing on     cardiomyopathy, with the following objectives:        -  To define the incidence of cardiomyopathy in allogeneic stem cell transplant patients          enrolled in National Cancer Institute (NCI) and National Heart, Lung, and Blood (NHLBI)          protocols at the NIH Clinical Center        -  To document the presence or absence of various known or suspected risk factors for          cardiomyopathy in the documented cases.      The study consists of a chart review of patients who have had an allogeneic stem cell     transplant on either an NHLBI or NCI protocol since 1999.      This project is a first step in clarifying the cardiac complications following stem cell     transplantation, their incidence, and characteristics of the patient populations. It will     look at patient demographics, the characteristics of the cardiac complication, and known or     suspected risk factors.   "
191548|NCT00352222|"     To obtain additional data on safety and efficacy of the Express stent implantation in the     treatment of stenosed or occlusive atherosclerotic disease (de novo or restenotic lesions) in     the iliac arteries (common or external).   "
191549|NCT00352235|"     Phase I/II trial of KRN7000 in patients with chronic hepatitis C.      Study objectives: To evaluate and compare the safety and tolerability of 3 ascending doses of     a-GalCer.      The primary efficacy parameter: HCV-RNA response at the end of treatment. Secondary efficacy     parameter: Serum ALT response. Further objectives of the study are to evaluate the effect of     a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells.      Number of dose levels: 3 Investigational product: KRN7000 Route of administration:     intravenous Dosages and frequency: 0.1, 1, 10 mcg/kg, monthly injection, 3 times (day 0, day     28 and day 56)   "
191550|NCT00352248|"     We aim to study the efficacy of Acupuncture versus sham acupuncture in children with ASD.   "
191551|NCT00352261|"     The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and     lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients   "
191552|NCT00352287|"     The purpose of the study was to determine the effects of growth hormone and an insulin     sensitizer drug in pre-diabetic adults with excessive amounts of abdominal fat. Participants     received a combination of two drugs: (1) recombinant human growth hormone (or its placebo)     and (2) pioglitazone (or its placebo). We measured the abdominal fat content and blood sugar     levels of participants before and after 40 weeks of treatment.   "
191553|NCT00352300|"     This phase I trial is studying the side effects of giving carboplatin and paclitaxel together     with pegfilgrastim in treating patients with stage III or stage IV ovarian epithelial,     fallopian tube, primary peritoneal, or carcinosarcoma cancer. Drugs used in chemotherapy,     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Colony-stimulating factors,     such as pegfilgrastim, may increase the number of immune cells found in bone marrow or     peripheral blood and may help the immune system recover from the side effects of     chemotherapy. Giving carboplatin and paclitaxel together with pegfilgrastim after surgery may     kill any tumor cells that remain after surgery.   "
191568|NCT00352495|"     RATIONALE: Drugs used in chemotherapy, such as vinblastine and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vinblastine when     given together with carboplatin in treating young patients with newly diagnosed or recurrent     low-grade glioma.   "
191670|NCT00353847|"     The purpose of this study is to determine whether acupuncture is effective and safe in the     treatment of chronic LBP.   "
191671|NCT00353860|"     This study will evaluate the safety and effectiveness of stem cell transplantation in which     the donor s T cells (a type of lymphocyte, or white blood cell) have been removed and then     added back. Certain patients with bone marrow malignancies undergo transplantation of donated     stem cells (cells produced by the bone marrow that mature into the different blood components     white cells, red cells and platelets) to generate new and normally functioning bone marrow.     However, T-cells from the donor may see the patient s cells as foreign and mount an immune     response to reject them, causing what is called graft-versus-host-disease (GVHD). Therefore,     in this study, T-cells are removed from the donor cells to prevent this complication.     Nevertheless, there are disadvantages of removing the T-cells, since they are important in     fighting viral infections as well as any remaining malignant cells. The attack against the     malignant cells is called a graft-versus-leukemia effect. Therefore, donor T cells are given     to the patient (added back) later (45 and 100 days after the transplant) when they can     provide needed immunity with less risk of causing GVHD.      Patients between 10 and 55 years of age with chronic myelogenous leukemia, acute     lymphoblastic leukemia, acute myelogenous leukemia, a myelodysplastic syndrome,     myeloproliferative disorders, or chronic lymphocytic leukemia may be eligible for this study.     Prospective participants and their donors are screened with a medical history and physical     examination, blood tests (including a test to match for genetic compatibility), breathing     tests, chest and sinus X-rays, and tests of heart function. They also undergo a bone marrow     biopsy and aspiration. For this procedure, done under local anesthetic, about a tablespoon of     bone marrow is withdrawn through a needle inserted into the hipbone.      Participants may undergo apheresis to collect lymphocytes for research studies. This     procedure involves collecting blood through a needle in the arm, similar to donating a unit     of blood. The lymphocytes are then separated and removed by a cell separator machine, and the     rest of the blood is returned through a needle in the other arm.      Before treatment begins, patients have a central venous catheter (flexible plastic tube)     placed in a vein. This line remains in place during the stem cell transfusion and recovery     period for drawing and transfusing blood, giving medications, and infusing the donated cells.     Preparation for the transfusion includes irradiation and chemotherapy. Patients undergo total     body irradiation in 8 doses given in two 30-minute sessions a day for 4 days. Four days     before the transfusion, they begin taking cyclophosphamide, and 9days before the procedure     they start fludarabine. These are anti-cancer drugs that kill the cancer cells and prevent     rejection of the donated cells. While the patient is receiving chemotherapy, the donor     receives daily injections for 6 days of G-CSF, a drug that moves stem cells from the bone     marrow into the blood stream. On days 1 and 2 after chemotherapy is completed, the stem cells     are infused into the patient through the central line.      Patients usually stay in the hospital about 20 to 30 days after the transplant to recover     from treatment side effects, which may include fever, nausea, diarrhea and mouth pain, and     receive blood transfusions, if needed. Treatment with cyclosporine, a drug that helps     prevents both rejection of donated cells and GVHD, is started on day 44 one day before the     first T-cell add-back. Patients return to the clinic for follow-up with various tests,     treatments and examinations as required, with a minimum of visits at least once or twice a     week for 2 to 4 months after the transplant; then at 4, 6, 9, and 12 months, and then yearly     for at least 3 years.   "
191555|NCT00352326|"     For children who depend on devices to communicate, the rate of communication is a primary     determinant of success. For children with motor impairments, the rate of communication may be     limited by inability to contact buttons or cells rapidly or accurately. It is therefore     essential to know how to adjust the device interface in order to maximize each child's rate     of communication. The optimal rate of communication is determined by the Channel Capacity,     which is the maximum value of the Information Rate for all possible keyboard button or cell     layouts for the communication device. We construct a mathematical model for the information     rate based on the relationship between movement time and the number of buttons per screen,     the size of the buttons, and the length of a sequence of buttons that must be pressed to     communicate each word in the vocabulary. We measure the parameters of the model using a     custom-programmed touch-screen interface.   "
191556|NCT00352339|"     Switching from Risperidone to Aripiprazole in early stage of pharmacotherapy will demonstrate     the same efficacy as compared to risperidone continuation treatment in the treatment of     schizophrenia.   "
191557|NCT00352352|"     This is a study of the efficacy of acupuncture in children with autism.   "
191558|NCT00352365|"     This phase II trial is studying how well lenalidomide works in treating older patients with     acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as     lenalidomide, may stimulate the immune system in different ways and stop cancer cells from     growing.   "
191559|NCT00352378|"     This is an open labeled phase III randomized trial. The patients with clinical stage II and     III will undergo mammotome biopsy of breast tumor for histologic diagnosis,     immunohistochemical studies for estrogen receptor(ER), progesterone receptor(PR), HER-2/neu     and others. PET results will determine the positivity of lymph node metastasis.   "
191560|NCT00352391|"     The goal of this research study is to look at how long individuals who have been treated for     early stage NSCLC or HNSCC live without developing lung cancer. Another goal is to develop     tools to help predict the likelihood of lung cancer occurrence in this population. This will     be done by studying characteristics of tissue and bodily fluids (including blood).      Objectives:        -  To assess the smoking-related disease-free survival in patients who are current or          former smokers with a prior definitively-treated stage I/II lung or head and neck          cancer.        -  To develop a risk model to help predict the likelihood of lung cancer development both          imaging and biomarker based in this high-risk population.   "
191561|NCT00352404|"     Timely diagnosis of intraepithelial neoplasias (premalignant condition)is of crucial     importance for clinical management of ulcerative colitis. We assessed the value of combined     chromoscopy and endomicroscopy for diagnosis of intraepithelial neoplasias in a randomised     controlled trial.      Endomicroscopy is a new device which enables microscopy of the mucosal layer during ongoing     colonoscopy. Chromoscopy means topical staining of mucosal surface to unmask areas of     interest, which are subsequently examined with the endomicroscopic system.   "
191562|NCT00352417|"     This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory     biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy   "
191563|NCT00352430|"     This study will evaluate new treatments for people who have pulmonary hypertension, or high     blood pressure in the lungs, caused by sickle cell anemia or thalassemia.      Patients ages 18 and older with a diagnosis of sickle cell disease or thalassemia, who have     mild to severe pulmonary hypertension, and who are not pregnant or breastfeeding may be     eligible for this study. There are three stages in the study, with up to 200 participants in     the screening. Patients will undergo pulmonary function tests, including those for asthma and     measurement of oxygen levels in the arterial blood. They will have a chest X-ray, computed     tomography (CT) scan of the lungs, ventilation perfusion lung scan to look for blood clots,     echocardiogram, test to measure how far patients can walk in 6 minutes, nighttime oxygen     measurement done while asleep, blood collection, magnetic resonance imaging (MRI) scan of the     heart, and exercise test. About 3 to 4 days are needed for the tests, all of which can be     done while patients are outpatients, except for the sleep study. For the CT scan, patients     lie on a table while an X-ray beam takes images of the lungs and heart. The lung scan     involves breathing of a small amount of a radioactive aerosol called Tc99m DTPA while     pictures are taken of the lungs from various angles. Then an injection of albumin, a protein     with a small amount of radioactivity, will be given, and more lung pictures will be taken.     For the MRI scan, patients lie on a table that slides into a machine. A medication called     gadolinium will be injected, to help improve images made through the scan. After the tests,     patients will be admitted to the Clinical Center for 1 day. A small plastic catheter, or     tube, will be placed in the vein of an arm. A longer catheter will go into a deeper vein     (neck or leg), and a pulmonary artery catheter will be inserted to measure blood pressure in     the blood vessels. Doctors will guide the catheter into the lung artery. Patients will be     asked to pedal on a stationary bicycle while heart and lung pressure is measured. If     pulmonary hypertension is present, patients will proceed to the second stage (up to 50     participants). While the catheter is still in place, patients will wear a face mask and     breathe nitric oxide (NO) for 20 minutes. They will take 50 mg of sildenafil by mouth, and     pressure in the heart and lungs will be monitored for about 4 hours. They will again receive     NO for another 20 minutes. Blood samples will be taken, and the heart rhythm and pressure in     the lungs will be monitored. Sildenafil can cause headache, flushing, and indigestion. Side     effects of the lung scan involve allergic reactions to DTPA and albumin. Patients with an     allergy to eggs should not have that test.      Up to 25 patients can enter the third stage. They will breathe NO by using a tank of gas that     delivers it through tubes to the nose, for a period of 6 weeks. They will continue taking     sildenafil as previously prescribed and visit the clinic every 2 to 4 weeks for an     echocardiogram, blood tests, and 6-minute walk test. After 6 weeks, patients will have     catheterization of the heart again to measure pressure in the heart and lungs. Then NO will     be stopped, and pressure in the lungs will be checked to see if NO has helped lower the blood     pressure-and to make sure that the blood pressure does not increase when medication is     stopped. Patients whose symptoms have improved as a result of breathing NO may wish to     continue with that therapy.   "
191564|NCT00352443|"     RATIONALE: Lapatinib and everolimus may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Everolimus may also stop the growth of cancer cells by     blocking blood flow to the cancer. Giving lapatinib together with everolimus may kill more     cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and     everolimus in treating patients with advanced solid tumors or non-Hodgkin's lymphoma.   "
191565|NCT00352456|"     This study is directed toward a better understanding of how the brain regulates emotions and     social and antisocial behavior. It will look at the use of the orbital frontal cortex and     amygdala of the brain. Brain changes are involved in solving conflicts and the feelings that     such conflicts produce. Conflicts may occur with other people or with general social rules.     The researchers' expectations are that the findings will be useful in developing therapies     that may improve people's ability to solve social conflicts and reduce antisocial behavior.      Adults ages 20 to 50 years of age with psychopathy and a second set of comparison adults, all     of whom have been released from the Fairfax County Adult Detention Center, may be eligible     for this study.      The neurocognitive component of the study, the one pertaining to performance of various     tasks, will involve 20 adults with psychopathy and 20 comparison adults. The neuroimaging     component, in which a magnetic resonance imaging (MRI) scan is used, will involve 18 adults     and 18 comparison adults. Two visits by participants will be entailed. At the first visit,     patients will undergo the following procedures and tests:        -  Physical examination        -  Test of vital signs, lying and standing.        -  Electrocardiogram.        -  Collection of blood for chemistry and hematology.        -  Urinalysis and liver function tests.        -  Screen for HIV and hepatitis.        -  Pregnancy test, if applicable, at the first visit and at all further visits.      Depending on the group to which they are assigned, at the second visit, patients will undergo     an MRI scan or take part in a variety of computer-based tasks to measure different forms of     thinking skills, emotional responses, and decision making. During the MRI scan, patients will     lie still on a table that will slide into the enclosed tunnel of the MRI scanner. They will     be asked to lie as still as possible. As the scanner takes pictures, patients will hear     knocking or beeping sounds, and they will wear earplugs to reduce the noise. Patients will be     able to communicate with the MRI staff at all times during the scan, and they may ask to be     moved out of the machine at any time. While lying in the MRI scanner, patients will be asked     to perform tasks presented via a screen. These tasks will involve looking at pictures or     words, and patients will be asked to make decisions about the pictures. The MRI scan will     take no more than 2 hours. In regard to the computer-based tasks that participants will     perform, the tasks are often games presented on a computer. Via computer, or on paper, there     may be presentations of pictures that bring about an emotion.      There will be no direct treatment or therapeutic benefits to participation in this study.     However, the knowledge gained may help people in the future.   "
191566|NCT00352469|"     Alcohol use disorders (AUDs) are a major problem facing our society. Their treatment is     complex, and involves multiple behavioral and pharmacotherapy interventions. There are 3     approved medications for AUDs, but their efficacy for AUDs that co-exist with anxiety     disorders is unknown. This study explores the effects of the medication, sustained-release     quetiapine fumarate (Seroquel SR) for the treatment of alcohol dependence and co-morbid     anxiety. Primary outcome measure is the amount of alcohol used. Secondary outcome measures     include craving for alcohol, length of sobriety from drinking and level of anxiety with     Seroquel SR.   "
191567|NCT00352482|"     Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's     ability to breathe. Currently, no medications can reverse the damage to the lungs caused by     IPF, but individuals are encouraged to engage in moderate exercise to strengthen lung     function. This study will evaluate the effectiveness of sildenafil at improving exercise     tolerance and breathing difficulties in individuals with IPF.   "
191605|NCT00352976|"     This is a single arm, total body irradiation (TBI) trial. All patients will be prescribed TBI     300 cGy with the goal of evaluating secondary endpoints.   "
191606|NCT00352989|"     The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool     weight, when compared to placebo, in the treatment of acute diarrhoea in children.   "
191569|NCT00352508|"     The supermarket industry now services many customers through online food shopping over the     Internet. The Internet shopping process offers a novel opportunity for the modification of     dietary patterns. The aim of this study was to evaluate the effects on consumers’ purchases     of saturated fat of a fully automated computerised system that provided real-time, personally     tailored advice recommending foods lower in saturated fat.   "
191570|NCT00352521|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also block blood     flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving bevacizumab together with irinotecan may kill more tumor cells. Diagnostic     procedures, such as MRI, may help doctors predict a patient's response to treatment and help     plan the best treatment.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with irinotecan     works in treating patients with recurrent malignant glioma and how well MRI predicts response     to treatment.   "
191571|NCT00352534|"     This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without     radiation therapy or observation only to see how well they work in treating patients     undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs     used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these     treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after     surgery, the tumor may not need additional treatment until it progresses. In this case,     observation may be sufficient.   "
191572|NCT00352547|"     This study will evaluate the effects of certain genes (MDR-1, CYP3A4, and CYP3A5) on     metabolism of the drug sirolimus, an immune-suppressing drug given to transplant recipients     to prevent organ rejection. Individual differences in metabolism and excretion of sirolimus     affect the patient's response to treatment.      Patients who have undergone kidney transplantation at the National Institute of Diabetes and     Digestive and Kidney Diseases (NIDDK) Transplant Branch and have received sirolimus treatment     will be enrolled in this study.      DNA (genetic material) will be extracted from blood samples collected from transplant     recipients to determine their MDR-1, CYP3A4, and CYP3A5 genotypes. Patient demographic     information and data on sirolimus metabolism and excretion will be collected from the medical     information system, NIDDK transplant database, and the patients' medical records. The data     will be compared among patients with different genotypes (genetic constitution of an     individual) and haplotypes (set of genes that code for different proteins but are inherited     as a unit) to determine the effect of these gene variations on sirolimus metabolism.      Information from this study may be applied to developing better dosing strategies, and thus,     treatment outcomes for transplant patients receiving sirolimus.   "
191573|NCT00352560|"     The main purpose of the study is to compare the mean AERP between treatment groups based on     the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological     remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to     placebo.   "
191574|NCT00352573|"     This study will survey a random sample of 2,100 general medicine physicians in Europe and in     the U.S. about ethical difficulties they face in their practice of medicine. The participants     will complete a questionnaire designed to meet the following study objectives:        -  Identify the types of ethical dilemmas physicians report that they face in their          practice and approaches they find helpful in responding to these situations        -  Determine what ethical support physicians would find useful in dealing with ethically          problematic situations        -  Explore physicians experience with 'bedside rationing', due to economic or societal          constraints, what procedures they forgo as a result, and what criteria they use in their          rationing decisions        -  Explore physicians perceptions of the equity of the health care system they work in        -  Determine what interventions directed at limiting health care costs physicians would          find acceptable.      Physicians in Italy, Norway, Switzerland and the United Kingdom who practice direct patient     care for at least 20 percent of their time may enroll in this study.      The practice of medicine sometimes involves situations where important values come into     conflict. The refusal of life-saving treatment, the concern that telling the truth could have     problematic consequences, acceptable ways of facing a request to die all are examples of     dilemmas that can arise in the practice of medicine. The absence of clear-cut 'right answers'     to questions raised by these situations have led to the development of support services, such     as ethics consultations, to help in decision-making concerning ethical problems that arise in     clinical settings. Information from this survey can provide input into the continuing     development of ethics support services by establishing an evidence base regarding the ethical     difficulties encountered by physicians and the type of support they would consider useful in     resolving these dilemmas.   "
191575|NCT00352586|"     This study will evaluate whether the drug D-cycloserine (DCS) can improve a type of learning     called classical conditioning, in which the brain learns to associate neutral stimuli with     stimuli that elicit emotional or physiological responses. DCS is an antibiotic that was     initially approved to treat tuberculosis and has been tested in clinical trials over the last     decade for enhancing cognitive function. This protocol includes both a pilot study and a main     study. The main study will begin after the pilot study ends.      Healthy normal volunteers between 18 and 45 years of age may be eligible for these studies.     Candidates will be screened with a medical and psychiatric history and a physical examination     that includes blood and urine samples, an electrocardiogram (EKG), hearing test and startle     test. The startle test involves recording eyeblink responses to loud noises.      After the screening visit, those enrolled will participate in the pilot or main study, in     which their reactions to two types of stimuli-an unpleasant, but harmless, shock to the arm     and a mild puff of air to the eye-will be measured and recorded.      - Pilot Study      Session 1 - Participants will receive very brief electric shocks delivered through two     electrodes attached to the forearm or fingers and will hear brief loud sounds that may     startle. Geometric shapes will be presented on a computer monitor.      Sessions 2 and 3 - The procedure is the same as in session 1, except participants will also     be subjected to brief low-intensity tones and airpuffs to the eye.      - Main Study      Participants will undergo the same procedures described in the pilot study, with the     following additions:        -  They will have an intravenous tube placed in a vein for collecting blood during the          test.        -  They will take a pill each test day that contains either 100 mg DCS, 500 mg DCS, or a          placebo (inactive substance). Subjects assigned to receive DCS will get the active drug          on only one of the three test sessions and will be given placebo the other two sessions.          The placebo group will receive placebo all three sessions.      In both the pilot and main study, subjects' physiological responses to the stimuli will be     recorded. Electrodes will be placed on two fingers (to measure sweat, or electrodermal     activity), on the ribcage midway between the waist and armpit (to measure heart rate), and     under one eye (to measure eye blink). Pulse will be recorded with a device attached to a     finger, and breathing rate will be recorded with a special belt placed around the chest. At     various times during the sessions, subjects will fill out questionnaires about their     experience. Participants may withdraw from the study at any point.   "
191613|NCT00353080|"     To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or     increasing bone mass in lumbar spine in osteopenic postmenopausal women      To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in     maintaining or increasing bone mass in proximal femur and decreasing bone resorption      To confirm general safety of 5 mg daily risedronate as compared to placebo   "
191576|NCT00352599|"     Neurofibromatosis type I (NF1) is a genetic disorder that affects approximately 1 in 3500     individuals. Half of people with NF1 inherit the condition from a parent, and half have a new     occurrence of the condition. The manifestation of NF1 is highly variable and multiple organ     systems are typically affected. Some of the more common symptoms include benign     neurofibromas, café au lait spots, Lisch nodules (tan spots on the iris of the eye). Some     individuals with NF1 also exhibit more severe associated conditions, such as optic pathway     tumors (gliomas) or bones bending or curving. Neurocognitive deficits and specific learning     disabilities occur in approximately 30 to 50% of individuals with NF1 and are regarded by     some observers and sufferers to be among the most troubling features of a disease. The most     commonly reported findings are deficits in visuoperceptual ability, motor coordination,     expressive and receptive language, and executive functioning, which requires intact     short-term memory and attention. Patients with NF1 also show a slight depression in mean IQ     scores compared to healthy adults without the disorder.      While cognitive deficits are now a widely-recognized feature of Neurofibromatosis Type 1     (NF1), the precise cause of these deficits still remain to be determined. Dr. Alcino Silva, a     co- investigator on this study, has developed an animal model of NF1 in which mice have a     specific mutation of the *NF1* gene. These mice are physically normal but show specific     learning impairments. Dr. Silva's lab found that treatment with a medication called     lovastatin, a drug typically used for high cholesterol, reversed some of the spatial deficits     seen in these animals. Lovastatin is a medication commonly used to treat high cholesterol and     has been proven to be relatively safe and tolerable in humans.      The investigators are now conducting a randomized, double-blinded, placebo- controlled, trial     of lovastatin in patients with NF1. Participants will be randomly assigned to lovastatin or     placebo and treated for approximately 14 weeks with baseline and follow-up assessments to     evaluate safety and any effects on neurocognitive test performance.   "
191577|NCT00352612|"     The purpose of this study is to help define the role of antibiotics in the treatment of     pediatric skin infections caused by community-associated methicillin-resistant Staphylococcus     aureus (CA-MRSA). The investigators hypothesize that treatment with cephalexin, a     penicillin-like antibiotic to which CA-MRSA would be expected to be resistant, does not     result in poorer outcomes than treatment with clindamycin, an antibiotic to which CA-MRSA is     most often susceptible.   "
191578|NCT00352625|"     The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain     associated with tendonitis or bursitis of the shoulder, elbow or knee.   "
191579|NCT00352638|"     RATIONALE: Printed educational materials and counseling by telephone may improve colorectal     cancer screening compliance in brothers and sisters of patients with colorectal cancer.      PURPOSE: This randomized phase III trial is studying standard or personalized printed     educational materials with or without telephone counseling to compare how well they work in     increasing colorectal cancer screening compliance in brothers and sisters of patients with     colorectal cancer.   "
191580|NCT00352651|"     The purpose of this study is to see if therapy with the drug pregabalin relieves pain during     shingles compared with placebo. A placebo is an inactive substance. Pregabalin is a drug     marketed as Lyrica™ in the United States for the treatment of seizures, diabetic neuropathy,     and post-herpetic neuralgia. The use of pregabalin and drugs like it for the treatment of     pain during the acute phase of shingles is experimental. Thirty four subjects will complete     the study at the University of California, San Francisco (UCSF) Pain Clinical Research     Center. This study is funded by Pfizer Global Research.   "
191581|NCT00352664|"     Primary Objective:      1. To determine the effectiveness of donepezil as compared to placebo for the management of     opiate-induced sedation/drowsiness in patients with stable cancer pain      Secondary Objectives:        1. To assess the side-effects in both groups of 1 week treatment of 5 mg donepezil and          placebo        2. To assess the effects of donepezil on fatigue (FACIT-Fatigue), and other symptoms          (Anderson Symptom Assessment Scale)        3. To assess the effects of donepezil on cognition (Symbol Digit Modalities Test)        4. To assess the effects of donepezil on constipation (number of bowel movements)   "
191582|NCT00352677|"     The purpose of this study is to determine the safety and effectiveness of INNO-406 in adult     patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+)     leukemias.   "
191583|NCT00352690|"     This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the     treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy     in a multi-institutional trial. Consolidation chemotherapy with paclitaxel poliglumex and     carboplatin will follow the completion of chemoradiation.   "
191584|NCT00352703|"     This is an open-label, single-arm, multicentre study conducted in Spain to estimate the     effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days     before the start of the conditioning regimen and for 3 consecutive days after autologous     PBSCT for treating oral mucositis in patients with NHL and MM who have received high-dose     conditioning chemotherapy.   "
191585|NCT00352716|"     The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool     weight, when compared to placebo, in the treatment of acute diarrhoea in children.   "
191586|NCT00352729|"     The purpose of this study is to see if treating a donor site wound with the ACell dressing is     as good as or better than the dressings we currently treat harvested donor sites with. This     will be tested on consenting burn patients who require excision and grafting surgery for     their burn wounds.      Hypothesis: The mean healing time for wounds treated with the ACell dressing will be less     than the mean healing time for wounds treated with the Standard of Care dressing.   "
191587|NCT00352742|"     The purpose of this study is to describe the safety and effect of ATN-224 in combination with     bortezomib (Velcade®) in patients with Multiple Myeloma who are relapsed from or refractory     to bortezomib.   "
191588|NCT00352755|"     This study prospectively evaluates a multidisciplinary approach to patients with     intraperitoneal carcinomatosis at Washington University. Patients with peritoneal     carcinomatosis or pseudomyxoma peritonei will undergo debulking surgery with peritonectomy     and placement of adhesive barrier film followed by repeated delayed intraperitoneal     chemotherapy with 5FU with systemic oxaliplatin-based chemotherapy on a biweekly schedule. A     retrospective review of patients treated in a similar manner at our institution showed good     tolerance and efficacy. This formal Phase II study is planned to determine the safety,     toxicities and survival of patients with peritoneal carcinomatosis and pseudomyxoma peritonei     treated with this regimen.   "
191589|NCT00352768|"     This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment     of children and adolescents with obsessive-compulsive disorder   "
191607|NCT00353002|"     All patients undergoing venepuncture or venous cannulation in pediatric emergency department     will be treated with either Amethocaine, or Liposomal Lidocaine (4%) cream at the site of     cannulation in order to determine the efficacy of these creams in controlling pain during     procedures and to determine the success rate of these procedures.   "
191590|NCT00352781|"     Approximately 2 million Ontarians are current smokers. While smoking rates have declined over     the past 25 years, these rates have remained constant since 2002. The rate of smoking     cessation in Ontario has not kept up with the rest of Canada. A new strategy is necessary to     increase the number of smokers making quit attempts and to increase the odds of quitting over     the long term.      The overall goal of the Stop Smoking Therapy for Ontario Patients (STOP) Study is to evaluate     the methods and effectiveness of providing nicotine replacement therapy (NRT) to Ontario     smokers. The study will develop an evidence-based protocol for providing NRT, provide faculty     development on combining pharmacotherapy with behavioural interventions and will provide an     evaluation framework to inform future coverage models.      The goal for this phase of the STOP study is to provide faculty development on combining     pharmacotherapy with behavioural interventions. This will be achieved by partnering with     Public Health Units across Ontario who have established smoking cessation clinics but do not     have the finances in place to offer NRT to their clients at a subsidized rate or free of     charge. Cost has been shown to be a significant barrier to the access and use of NRT in     individuals trying to quit smoking. However, combining pharmacotherapy with behavioural     interventions may be more effective than either alone. Therefore, we hypothesize that     providing NRT free of charge to clients enrolled in a smoking cessation clinic will be more     effective for smoking cessation than behavioural interventions alone.   "
191591|NCT00352794|"     The goal of this clinical research study is to learn if lenalidomide in combination with     prednisone can help to control myelofibrosis. The safety of lenalidomide and prednisone for     the treatment of myelofibrosis will also be studied.   "
191592|NCT00352807|"     The purpose of this study is to obtain and assay human aqueous samples following     pre-operative dosing with 0.1% Brimonidine Purite™ (pH 7.8) or with 0.15% Brimonidine Purite®     (pH 7.2) from patients undergoing routine cataract surgery in order to evaluate the aqueous     concentration of the two formulations.Study hypothesis: The aqueous humor concentration 45     minutes following dosing of 0.1% Brimonidine Purite™ (pH 7.8) is comparable with 0.15%     Brimonidine Purite® (pH 7.2)   "
191593|NCT00352820|"     The objective of this study is to explore the experience of informal caregivers of patients     with a primary brain tumor, identifying elements and themes of the caregiving experience     specific to this population of caregivers. The aim is to describe the experience of being an     informal caregiver for a patient with a primary brain tumor.   "
191594|NCT00352833|"     Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery     alone in patients after curative resection of a gastric adenocarcinoma in order to gain more     detailed information primary on safety, tolerability and feasibility and secondary on     relevant efficacy parameters.   "
191595|NCT00352846|"     Primary Objective:        -  Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total          lumbar spine and femoral neck.      Secondary Objectives:        -  Evaluate the effect of zoledronate on change in BMD at the total hip        -  Evaluate risk factors for developing osteoporosis on chemotherapy        -  Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect          on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with          calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).   "
191596|NCT00352859|"     The purpose of this study is to see if taking interferon or gemcitabine along with sorafenib     will stop the advanced renal cell cancer from becoming worse in some people. To do this,     sorafenib along with gemcitabine or interferon will be compared to treatment with gemcitabine     or interferon alone. More safety information on sorafenib will be also collected. About 260     patients with progressed renal cell cancer will be in this study.   "
191597|NCT00352872|"     The goal of this pilot study is to delineate the role of genetic variations in premature     menopause, hot flashes, and other toxicities in a cohort of premenopausal women with early     breast cancer.      Primary Objective- To ascertain the effect of common variant alleles of CYP450 2B6, 2C19,     2C9, and 3A5 in pre-menopausal women with breast cancer receiving anthracycline and     cyclophosphamide based chemotherapy as it relates to occurrence of premature menopause     (defined as more than 12 months of amenorrhea and serum estradiol and FSH levels consistent     with post-menopausal status)      Secondary Objective #1- To obtain pilot data on the effect of common variant alleles of     CYP450 2B6, 2C19, 2C9, and 3A5 in pre-menopausal women with breast cancer receiving     anthracycline and cyclophosphamide based chemotherapy as it relates to occurrence of hot     flash frequency, and other common toxicities of therapy requiring dose delay or reduction.      Secondary Objective #2- To obtain pilot data on the correlation of hot flashes with serum     levels of serotonin, tryptophan, and their metabolites and with polymorphisms of the     serotonin transporter and receptor genes.   "
191598|NCT00352885|"     This study will determine the effectiveness of an antidepressant in preventing or reducing     depressive symptoms in people with melanoma who are receiving Interleukin-2 (IL-2) treatment.   "
191599|NCT00352898|"     Since measles-mumps-rubella (MMR) and varicella vaccinations are established as routine     childhood practice and often co-administered during the second year of life, a combined     measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine is fully justified. Such a combined     vaccine was developed and extensively studied in susceptible children. In countries where     varicella mass-vaccination is already implemented, a transition period is necessary as     children who started with separate first-dose vaccinations of MMR and varicella will receive     a single shot of the combined vaccine as the second dose. To account for those situations,     this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine     given in place of separate MMR and varicella vaccines as a second dose.   "
191600|NCT00352911|"     The objective of the study is to determine whether mifepristone (VGX-410) has anti-HIV-1     activity at doses of either 300 mg or 600 mg per day after oral administration for 14 days at     each dose level.   "
191601|NCT00352924|"     The Agricultural Health Study (AHS) is a collaborative effort between the National Cancer     Institute and the National Institute of Environmental Health Sciences. The U.S. Environmental     Protection Agency and the National Institute for Occupational Safety and Health are providing     support for a limited exposure assessment effort.      Initial data collection on a prospective cohort of 89,658 study subjects has been completed     as of December 1997. Participants completed questionnaires that included items on pesticides     used, other agricultural exposures, and work practices that modify exposure as well as on     other activities that may affect either exposure or disease risks (e.g., diet, exercise,     alcohol consumption, medical conditions, family history of cancer, other occupations and     smoking history). Phase II of the study (1998-2003) updated information on occupational     exposures, diet, work practices and medical history by means of a computer assisted telephone     interview. We also collected buccal cells on sample of 34,000 study participants to assess     the effect of inheritable polymorphisms and the interaction of environment and genomic     predisposition.      The stimulus for this prospective investigation comes from the growing evidence that, despite     a low mortality overall, farmers experience an excess of several cancers. These excesses have     been observed in retrospective epidemiological studies among agricultural workers in several     countries. Excess cancers are observed for the lymphatic and hematopoietic system, connective     tissue, skin, brain, prostate, stomach and lips. Several of these tumors (brain, NHL,     multiple myeloma, and prostate) are also increasing in the general population in many of     these countries. This suggests a common set of exposures may explain the high rates in     farmers and rising rates in the general population.      Farmers, their families, and other pest control workers may have contact with a variety of     potentially hazardous substances including pesticides, solvents, fuels and oils, engine     exhaust, dust and zoonotic viruses and other microbes. Our cohort study includes all     registered pesticide applicators in Iowa and North Carolina and the spouse of applicators who     are farmers. The health effects of pesticide use are the primary focus of the study. The     influence of other farm exposures are also being evaluated.      The focus of the phase II follow-up period (2004-2008) is to update exposure information and     health histories by means of a computer assisted interview and also following the cohort to     determine disease incidence and mortality. The cohort is being followed through the cancer     registries within Iowa and North Carolina, the Social Security Administration database, state     vital statistics offices, National Death Index, and various in-state databases, such as the     listing of registered pesticide applicators. Individuals who enrolled into the study but who     are no longer at the address given during enrollment (based on subsequent attempts at follow     up) have been submitted and will continue to be submitted (through NIOSH) in the standard     format to the IRS under their Project 057 Taxpayer Address Request Program. Identifying data     provided to the IRS include only SSN and the first four letters of last name of cohort     member. IRS provides in return the most current address in IRS records if a match (SSN + all     four letter of last name) is found. The purpose of this effort is to identify members of the     cohort who have moved out of state, to enable adjustment of person-years for incidence and     mortality calculations. Persons who have moved out of state can be followed for vital status     and cause of death, but not for cancer incidence.      Continuation of the protocol will provide a valuable epidemiologic resource to help prevent     cancers in the future by identifying risk factors in the rural/agricultural environment.     Because more cases of important cancer outcomes occur in this cohort every year, potential     cancer causes can be evaluated with increased statistical power. Larger number of cases also     allows for statistical control of confounding factors, making more meaningful conclusions     about cancer risk, and, for some relatively infrequent cancers, such as the lyphomas and     leukemias, greater follow-up time is necessary to make any meaningful observations.   "
191602|NCT00352937|"     To compare the efficacy of 16-row multi-detector CT (MDCT) with standard myocardial perfusion     imaging in detecting coronary artery disease (CAD) in patients without a previously     established diagnosis of CAD.   "
191603|NCT00352950|"     To determine the dose and schedule of sirolimus when given in combination with panitumumab in     adult subjects with Stage IIIB/IV NSCLC   "
191609|NCT00353028|"     This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the     treatment of children and adolescents with depression or depressive state   "
191614|NCT00353093|"     Currently, patients with suspected deep vein thrombosis (DVT) of the lower extremities     receive the ultrasound investigation of their deep vein system, either by limited     ultrasonography (ultrasonography confined to the proximal veins, repeating the test after one     week in patients with positive D-dimer) or by extended ultrasonography (ultrasonography     extented to the entire deep vein system of the legs). No study has directly compared the two     strategies to assess their accuracy and safety. We plan to compare the accuracy and safety of     the two strategies in a prospective randomized study addressing more than 2000 consecutive     outpatients presenting with the clinical suspicion of DVT.   "
191615|NCT00353106|"     Primary Objectives:        1. To explore the experience of chronic graft-versus-host disease (cGVHD) following          allogeneic blood or marrow transplantation from the perspective of the patient and the          patient's primary family caregiver.        2. To develop and validate an instrument to measure the severity of multiple symptoms and          the impact of these symptoms on daily functioning in patients who have cGVHD.      Secondary Objectives:        1. To develop a detailed description of the experience of having cGVHD.        2. To develop a detailed description of the symptom experience of cGVHD to allow for          development of a symptoms instrument for cGVHD.        3. To assess the understanding of questions to measure the symptoms of cGVHD in patients          with various levels of education.        4. To develop a detailed description of caring for a patient with cGVHD.   "
191616|NCT00353119|"     Palmoplantar pustulosis (PPP) is a chronic recurrent skin condition characterized by the     presence of pustules, erythema and hyperkeratosis on palms and soles. PPP can be a severe and     disabling disease limiting the ability to walk or work. Although studies on the quality of     life of patients with PPP are not available, a recent investigation showed that palmoplantar     psoriasis (non pustular) has a more important impact on quality of life than plaque     psoriasis. This important impact on quality of life is not surprising as palmoplantar     psoriasis as well as palmoplantar pustulosis may limit the ability to work or conduct     activities with hands or even impair walking. The disease is sometimes associated with     psoriasis elsewhere on the body. Current treatments for PPP include topical corticosteroids,     cyclosporine, PUVA therapy, methotrexate and acitretin. Response to topical corticosteroids     and PUVA therapy is often disappointing presumably because the thickness of the stratum     corneum on palms and soles prevents good penetration of topical medications and light.     Cyclosporine and methotrexate are sometimes used with success for PPP but there are concerns     with long term toxicity of both drugs. Therefore there is a need for new treatments for PPP.   "
191617|NCT00353145|"     Primary objectives:        1. To determine the overall tumor response rate with oxaliplatin in combination with          gemcitabine (GEMOX) as first line and second line therapy in unknown primary cancer          (UPC).        2. To determine the tolerability (toxicity) of this regimen in this patient population.      Secondary objectives:        1. To determine the median overall survival (OS) and time to progression (TTP) for patients          treated with this combination.        2. To determine the impact of this combination on quality of life (QOL) in this patient          population.   "
191618|NCT00353158|"     This study will examine the phototoxicity, a reaction to light that is like exaggerated     sunburn, which occurs in people who take medications such as voriconazole, a medication used     to fight fungus. Sunscreens might protect the skin from the reaction. Although phototoxicity     from voriconazole is not completely understood, it may be related to how that medication is     metabolized in the liver by enzymes called cytochrome P450 enzymes-and mainly by one known as     2C19. A way to evaluate phototoxicity is through microarrays, which measure how much each     gene is expressed in cells from tissues such as skin.      Patients ages 8 and older who are scheduled to begin taking or who currently take     voriconazole may be eligible for this study. Also, patients ages 18 to 45 in good health who     have skin tone known as Type 2, which usually burns and tans only slightly following sun     exposure, may be eligible. All patients will visit the Dermatology Clinic. They will complete     two questionnaires, on medical history and medications, as well as the skin response to     sunlight, and donate about 3 teaspoons of blood. Patients who are scheduled to take     voriconazole will visit the clinic four times, that is, two visits 2 consecutive days before     beginning the medication and two visits on 2 consecutive days after taking it for at least 7     days. Each visit will take 1 to 2 hours. Patients about to take voriconazole will have a     blood test and undergo a physical exam of the skin test site, on the buttocks. Researchers     will take photographs of the specific site and do tests to measure skin reaction to     ultraviolet (UV) light. UV light will be shined on 15 small areas of the skin, each 1 x 1     centimeters. After 24 hours, any redness that occurs on the skin will be checked. Afterward,     patients will begin taking voriconazole according to directions by the researchers. At 10 or     more days later, patients will visit the clinic. Sunscreen will be applied and 1 hour later     after administration of voriconazole, a blood sample will be drawn to check the level of     medication. Then UV light will be shined on 23 areas of skin 1 x 1 centimeters. More     photographs will be taken of test sites to record changes in skin redness. On the next day,     the skin response will be evaluated. Participants in the control group will be asked to avoid     UV radiation by wearing hats and clothing, and using sunscreen. They will be given the     doxycycline, an antibiotic, and undergo procedures with UV light shined on small areas of the     skin, on the buttocks. Control participants will have 7 study days, with visits lasting from     1 to 3 hours and probably not exceeding 8 hours. They will have two shave biopsies on Study     Day 2 and on Study Day 7 to determine how the skin has responded to UV light exposures.   "
191619|NCT00353171|"     This study will examine whether exposure to organochlorines (certain chemicals such as PCBs     and DDE, used in pesticides or other industrial applications) is related to age at natural     menopause. It is known, for example, that smokers experience menopause 1 to 2 years earlier     than do non-smokers. This study will look for a similar association between organochlorine     exposure and menopause. It will also look for possible associations between specific factors,     such as pregnancy history and weight change, and changes over time in blood organochlorine     levels.      Women who participated in the North Carolina Infant Feeding Study between 1978 and 1982 are     eligible for this study. Participants will be interviewed over the phone for information     about their reproductive and menstrual history, as well as additional information that may be     related to age and menopausal status. Specifically, the interview will cover the following     areas: 1) pregnancy and breastfeeding history; 2) menstrual periods and menopause; 3) use of     birth control pills and hormone replacement therapy; 4) surgeries on the uterus or ovaries,     such as hysterectomy or oophorectomy, or both; 5) smoking and alcoholic beverage consumption;     6) physical activity; 7) weight history; and 8) medical history. About one-half of the     participants will have a blood sample drawn for analysis of the reproductive hormones FSH     (follicle-stimulating hormone) and LH (leuteinizing hormone) and of DDE and PCB levels.   "
191620|NCT00353184|"     Oral montelukast is helpful in chronic asthma. The purpose of this pediatric study was to     investigate whether the addition of oral montelukast to standard therapy for acute asthma     exacerbations results in further improvement in breathing function over three hours.   "
191640|NCT00353457|"     This is a phase II study of induction chemotherapy (capecitabine, oxaliplatin and cetuximab     (erbitux)) followed by capecitabine, oxaliplatin, cetuximab and radiotherapy followed by     surgery followed by adjuvant capecitabine, oxaliplatin and cetuximab for locally advanced     resectable rectal cancer.   "
191621|NCT00353197|"     Human embryonic stem cells (hESCs) are isolated from the early human embryo and have the     capability to proliferate indefinitely in culture and to develop into nearly every cell of     the human body. Therefore, hESCs may serve as a renewable unlimited source of cells for     transplantation therapy. Because of the use of animal products in their derivation, and due     to the lack of appropriate quality and process controls in the manufacturing of existing cell     lines worldwide, existing hESC lines are not suitable for utilization in transplantation     therapy.      Our objective is to derive several new hESC lines that will be suitable for clinical trials.     The investigators plan on deriving the new hESC lines utilizing only FDA-approved raw     materials in a non-animal culture system. They will be produced entirely under GMP     conditions, using appropriately documented procedures and analytical methods, completely     safety tested, and screened for infectious and adventitious agents.   "
191622|NCT00353210|"     Human embryonic stem cells (hESCs) are isolated from the early human embryo and have the     capability to proliferate indefinitely in culture and to develop into nearly every cell of     the human body. hESC are important for studying developmental biology and for cell     replacement therapies for the treatment of degenerative human diseases. An additional use for     embryonic stem cells would be for the in vitro study of diseases. hESC lines derived from     embryos diagnosed as abnormal by PGD testing would afford such models for study. Because     embryos tested by PGD and found to be abnormal would only under rare circumstances be     transferred to the uterus of a woman (and in most cases would be discarded), the derivation     of new hESC lines from these embryos would provide a viable less ethically-objectionable     source of cells with which to study the mechanisms of differentiation and developmental     biology.   "
191623|NCT00353223|"     This study will evaluate the effectiveness of interpersonal psychotherapy and behavioral     activation techniques in treating depression in people with congestive heart failure.   "
191624|NCT00353236|"     Delivery of twins or preterm infant is a very stressful episode to mothers. The purpose of     this study is to characterize maternal psychological resources in dealing with this situation     and compare it to mothers giving birth to singleton at term   "
191625|NCT00353249|"     This study will determine the effectiveness of cognitive behavioral therapy in treating     post-traumatic stress disorder in homeless women.   "
191626|NCT00353262|"     This single arm study will investigate possible pharmacokinetic interactions between Xeloda     and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is     influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic     analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a     treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in     cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study     treatment is 3-12 months, and the target sample size is <100 individuals.   "
191627|NCT00353275|"     The primary purpose of this study is to evaluate two glycemic control regimens on clinical     outcome in patients with necrotizing soft tissue infections. Secondary aim is to evaluate the     inflammatory and immune responses to the glycemic control regimens.   "
191628|NCT00353288|"     As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in     most industrialised countries and varicella vaccination is now being introduced in many     countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine     was developed for administration convenience and improved compliance to vaccination. To     account for situations where children have received a first dose of MMR vaccine without     varicella, this study will evaluate the effect of the combined     measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A     second dose of the monovalent varicella vaccine will be given to all children participating     to this trial since there is a current debate on the need of a second dose to induce a full     protection against varicella.   "
191629|NCT00353301|"     The purpose of this study is to test the safety and efficacy of the combination of erlotinib     hydrochloride (Tarceva™) and sirolimus (Rapamune™) in the treatment of patients with     metastatic kidney cancer.   "
191630|NCT00353327|"     To study the effect of passive immunotherapy (PIT) over the HIV-viral load and the CD4     T+-cell counts in patients who have failed to respond to three different Highly-Active     Antiretroviral Therapy (HAART), and who have at the moment less than 100 CD4+-T cells/ml and     a viral load over 20,000 copies/ml.   "
191631|NCT00353340|"     The objective of this study is to assess the efficacy of sodium bicarbonate compared with     sodium chloride and oral N-acetylcysteine (NAC ) pretreatment for prevention of contrast     nephropathy in patients with advanced renal disease undergoing cardiac catheterisation.   "
191632|NCT00353353|"     In the Netherlands fortification of food products is not yet mandatory. One of the major     arguments of the Dutch Health Council to advise against mandatory fortification is the     possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the     possibility of masking is: fortification of foods with both folic acid and vitamin B12. In     this study we want to assess the effects of this fortification strategy on markers of folate     and vitamin B12 status.   "
191633|NCT00353366|"     GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV)     vaccine in several countries. In view of its registration in the Philippines, the present     study will collect data on the safety of the vaccine in the local target population as per     the Bureau of Food and Drugs Directive.   "
191634|NCT00353379|"     This study will determine the effectiveness of guanfacine in improving cognitive and     functional impairments in schizotypal personality disorder.   "
191635|NCT00353392|"     The purpose of this study is to determine whether Q-Switched Nd:YAG Laser therapy are     effective in reduction of Cutaneous macular amyloidosis.   "
191636|NCT00353405|"     This study will evaluate the joint and separate effectiveness of two HIV/STD prevention     programs in providing protection against acquiring STDs and maintaining safer sex behavior.   "
191637|NCT00353418|"     This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg     weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg     daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment     will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
191645|NCT00353522|"     This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with     coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12     weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily     for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level     and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12     months, and the target sample size is 100-500 individuals.   "
191646|NCT00353535|"     The purpose was study the immunosuppression using total lymphoid irradiation plus Csa, MMF     and prednisone pretransplant to prevent focal segmental glomerulosclerosis recurrence in the     renal graft   "
191647|NCT00353548|"     This study will use a sipping and spitting exercise to better understand the brain's response     to food intake in people with eating disorders.   "
191648|NCT00353561|"     Clinical and mycological response to oral fluconazole and boric acid suppositories was     assessed in patients with diabetes mellitus and vulvovaginal candidiasis.   "
191649|NCT00353574|"     This is a research study of a new experimental drug called darusentan. Darusentan is not     currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in     the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is     to evaluate the long-term safety of darusentan in subjects with resistant systolic     hypertension despite treatment with full doses of three or more antihypertensive medications,     including a diuretic.   "
191650|NCT00353587|"     This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled     phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients     with type 2 diabetes receiving concomitant therapy with insulin. Eligible patients will be     adults with type 2 diabetes who are taking intermediate- and/or long-acting insulin or     pre-mixed (e.g., 70/30) insulin, or a combination of insulin and one or two non-TZD     hypoglycemic agents including sulfonylurea, metformin, acrabose or Byetta, but who are poorly     controlled on their existing therapy. Preference for enrollment will be given to patients on     insulin monotherapy. Patients treated with a combination of insulin and other hypoglycemic     agent(s) must be willing and able to discontinue and washout of the hypoglycemic agent(s) for     the entire duration of the study (in toto, approximately 28 weeks). Patients who are taking     fixed doses of a short-acting insulin (e.g., not a sliding scale) in combination with     intermediate-acting insulin may qualify for the study if both the patient and investigator     are willing to either change to pre-mixed insulin (e.g., 70/30) or discontinue use of the     short acting insulin for at least 26 weeks. Patients treated with a sliding scale of     short-acting insulin will not be eligible for enrollment.   "
191651|NCT00353600|"     A clinical intervention will be performed in adult diabetic Pima Indians with proteinuria to     determine if an angiotensin converting enzyme (ACE) inhibitor is effective in slowing the     progression of renal disease in persons with overt diabetic nephropathy attributable to type     2 diabetes mellitus (NIDDM).      The study will be conducted in the Gila River Indian Community and include proteinuric     subjects selected from the Diabetic Renal Disease Study (DRDS; NIH Protocol Number 88-DK-79)     in whom glomerular function has been measured at six-monthly intervals for the past 48     months. Twenty-five subjects (12 men, 13 women) aged 31-64 years are eligible for this study.     These subjects all have urinary albumin-to-creatinine rations >=300 mg/g (equivalent to 300     mg albumin/day), serum creatinine concentrations < 3.0 mg/dl, and no evidence of nondiabetic     renal diseases. Their GFR slopes average -0.49 ml/min/month (95% confidence interval, -0.91     to -0.07), and 11 of them (8 men, 3 women) are hypertensive (systolic blood pressure >=140 mm     Hg, diastolic blood pressure >=90 mm Hg).      Subjects will be treated with an ACE inhibitor, and measurements of glomerular filtration     rate (GFR) and renal plasma flow (RPF) will be made at six monthly intervals until the     subjects' progress to renal failure. GFR slope (ml.min/month) will be computed, and the slope     prior to the initiation of an ACE inhibitor will be compared with that obtained during     treatment.   "
191652|NCT00353613|"     The primary research question is whether interventions to prevent caregiver and system errors     will increase the proportion of laparotomy patients who receive recommended measures to     prevent surgical site infections.   "
191653|NCT00353626|"     Post traumatic amputees with an experience of over 3 months of prosthesis use at home,     without any known difficulty using the prosthesis and without stump pathology, using no     assistive devices, will be examined in a 3 D computerized gait laboratory. Kinematic and     kinetic parameters of gait will be obtained.   "
191654|NCT00353639|"     This study will evaluate and compare the genes of the telomere repair complex in healthy     control subjects, patients with blood diseases, and patients with inflammatory bowel disease     to identify what, if any, changes are associated specifically with inflammatory bowel     disease.      Patients between 2 and 80 years of age with ulcerative colitis or regional enteritis may be     eligible for this study. Participants are recruited from the practice of Dr. Stuart     Danovitch, Washington, D.C.      Researchers have established that minor differences in a specific set of genes called the     telomere repair complex are related to immune-mediated diseases of the bone marrow. NIH     researchers are now interested in whether inflammatory bowel disease and other autoimmune     diseases show a similar pattern of genetic differences.      Participants provide a cell sample for evaluation of the telomere repair complex. The sample     is collected via buccal swab, a gentle scraping of the inside of the cheek, and stored for     use in research.   "
191655|NCT00353652|"     Thiazide medications are often prescribed for individuals with high blood pressure, but     research has shown that they may increase an individual's risk of developing diabetes. While     it is unknown exactly how thiazide causes this response, it is likely that the nervous system     is somehow involved. This study will evaluate the role of the nervous system in sugar     metabolism, as well as determine the effect of thiazide and other medications on individuals     with high blood pressure.   "
191656|NCT00353665|"     The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate     affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the     calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the     progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the     single drug approved to treat ALS).   "
191657|NCT00353678|"     The purpose of this study is to find the best possible (optimal) dose (effect versus adverse     events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement     surgery.   "
191660|NCT00353717|"     Basal like breast carcinoma is a Her2, estrogen receptor (ER) progesterone receptor (PR)     negative breast cancer. It is notable for the high level of epidermal growth factor receptor     (EGFR) expression in this tumor subtype .      Thus the investigators wanted to combine the use of anti EGFR therapy in the form of Erbitux     (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of these women.     This is a small phase I/II study.   "
191661|NCT00353730|"     This study will identify genes and proteins in the blood of patients with atherosclerosis and     in that of normal volunteers. The findings will be compared to determine the influence of     these substances on the development of atherosclerosis a narrowing and hardening of blood     vessel walls by deposits of fatty substances. Blood vessel blockage caused by atherosclerosis     can impede blood flow and cause stroke, heart attack and poor limb circulation. The     information from this study may lead to better ways to detect, prevent and treat these     diseases.      Healthy volunteers and patients scheduled for carotid endarterectomy at Suburban Hospital in     Bethesda, Maryland, are eligible for this study. Carotid endarterectomy is a surgical     procedure in which the inner layer of the carotid artery (neck artery supplying blood to the     brain) is scraped away to open the blocked vessel. Participants will undergo the following     tests and procedures:      Patients        -  Blood sample: Collection of about 32 cc (8 tablespoons) of blood for genetic and protein          analysis        -  Tissue sample: Collection of a piece of diseased blood vessel discarded from the          endarterectomy procedure        -  Review of records: Review of medical records for information about past illnesses,          medications, tests, and so forth, if needed      Normal Volunteers        -  Blood samples: Collection of about 32 cc (8 tablespoons) of blood for genetic and          protein analysis        -  Carotid artery ultrasound: Ultrasound imaging of the neck arteries for detection of any          blockage        -  Electrocardiogram: Recording of the electrical activity of the heart to detect any          abnormalities in heart rhythm        -  Echocardiogram: Ultrasound examination to detect possible abnormalities of the heart          muscle        -  Cardiac stress test: Treadmill stress test to detect possible heart vessel blockage (for          subjects who have not had a cardiac stress test in the past year)        -  Review of records: Review of medical records for information about past illnesses,          medications, tests, and so forth, if needed   "
191662|NCT00353743|"     The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of     clinical improvement, the patient is discharged from the hospital without antibiotics. No     trials has been found in cases of septic abortion.      The purpose of the present study is to verify the need of antibiotics after clinical     improvement in cases of septic abortion.   "
191663|NCT00353756|"     The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in     patients with Crohn's disease.   "
191664|NCT00353769|"     The purpose of this study is to compare the effectiveness, complications and benefits of Hair     Apposition Technique(HAT)performed by nurses or doctors.   "
191665|NCT00353782|"     This study will evaluate people with dyslipidemias - disorders that affect the fat content in     the blood. Fats, or lipids, such as cholesterol and triglycerides, are carried in the blood     in particles called lipoproteins. These particles are involved in causing blood vessel     diseases that can lead to conditions like atherosclerosis (hardening of the arteries) or     heart attack. Participants will undergo accepted medical tests and procedures to evaluate     their condition. Most of the test results are helpful in making a diagnosis and in guiding     treatment.      People with lipid disorders are eligible for this study. Representative types of patients     include those with:        -  Plasma cholesterol levels greater than 200 mg/dl or less than 120 mg/dl        -  Plasma LDL-C levels greater than 130 mg/dl or less than 70 mg/dl        -  Plasma HDL-C levels greater than 70 mg/dl or less than 25 mg/dl        -  Unusual cholesterol deposits or xanthomas (nodules of lipid deposits on the skin)      Children under 2 years of age are excluded from the study.      Participants will undergo some or all of the following procedures:        -  Plasma evaluation. Apolipoproteins (plasma proteins involved in metabolism of          cholesterol, triglycerides, phospholipids, and proteins in the blood) and enzymes          involved in lipid metabolism are measured.        -  Fat biopsy. A small sample of fat tissue is collected for examination. For this test, an          area on the buttock or abdominal wall is numbed. A needle is inserted into the fat, and          a small amount of tissue is sucked out by a syringe.        -  Leukapheresis. White blood cells are collected to help diagnose the lipid disorder. For          this test, blood is collected through a needle in an arm vein, similar to donating          blood. The blood circulates through a machine that separates it into its components, and          the white cells are removed. The rest of the blood is returned to the body, either          through the same needle or through another needle in the other arm.        -  Skin biopsy. Skin cells are collected for study. The cells are grown in the laboratory          and the amount of cholesterol that enters or leaves the cells is measured, providing          information on abnormalities in cholesterol transport. For this test, an area of skin is          numbed with an anesthetic and a small circular area is removed, using a skin punch          instrument similar to a sharp cookie cutter.        -  Heparin infusion study. Heparin, a blood thinner, releases enzymes that break down fat          in the blood. Lipase activity (breakdown of fats) in the blood is measured following the          injection of heparin into a vein.   "
191666|NCT00353795|"     The overall goal of this study is to use MRI to:        -  Examine the relationship between known risk factors for cardiovascular disease and          coronary artery wall thickness;        -  Examine the relationship between coronary artery wall thickness and other markers of          subclinical coronary atherosclerosis, such as carotid wall thickness and coronary          calcium scores; and,        -  Examine the feasibility of measuring the progression of coronary artery wall thickness          over time in a subset of participants.   "
191667|NCT00353808|"     The purpose of this study is to assess the long-term safety and tolerability of     [S,S]-Reboxetine in patients with chronic pain following shingles. This is the extension     study of Protocol A6061026.   "
191721|NCT00354536|"     This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess     safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is     given at the same dose 7 days apart, and the impact this medication has on various substances     in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of     any side effects.   "
191752|NCT00348738|"     The purpose of this study is to determine whether an increase of blood haemoglobin levels     through the substitution of erythropoietin during radiotherapy treatment of cervix cancer     patients results in improvement for disease specific survival, tumor response and local     control.   "
191668|NCT00353821|"     This study seeks to investigate the factors that may account for the differences in the way a     stem cell recipient s immune system works after a transplant. It will focus on cytokine     genes, which give specific instructions to the genes and which may influence immune system     response. More specifically, the purpose of the study is to find out how gene polymorphisms     (gene variations among the population) affect the success or failure of a stem cell     transplant.      Study participants will have donated blood for a stem cell transplant. They will be asked to     give consent for NIH personnel to run special tests on these blood samples, which will have     been placed in storage. It is hoped that blood samples will be studied from 600 stem cell     donors.   "
191669|NCT00353834|"     The main goals of the study are to evaluate the effect of Exenatide on endothelial-dependent     vasodilation, as measured by flow mediated dilation (FMD), to evaluate the effect on     endothelial-independent vasodilation, as measured by nitroglycerin (TNG) response, and to     evaluate the effect on arterial stiffness, as measured by pulse wave analysis (PWA). We will     also measure the effects on various markers of endothelial function, subclinical     inflammation, fibrinolysis, and oxidative stress. The control group for the study will     receive Lantus insulin, with a goal of similar glycemic control between the treatment and     control groups.      Specific Aims      We will test the following hypotheses:        1. Treatment of patients with type 2 diabetes who are inadequately controlled by          monotherapy with a Sulfonylurea (SU) or Metformin, or on combination therapy of a SU and          Metformin with Exenatide (GLP-1 mimetic) will result in improved endothelial dependent          vasodilation, as measured by FMD, as compared to the control group, who will be treated          with Lantus insulin to achieve comparable HbA1c levels.        2. Treatment with Exenatide (GLP-1 mimetic) will result in improved arterial stiffness, as          measured by AI by PWA, as compared to the control group, who will be treated with Lantus          insulin to achieve comparable HbA1c levels.        3. Endothelial dependent vasodilation, as measured by FMD, and arterial stiffness, as          measured by AI, measured in the postprandial state (following a standard test meal) will          be improved following treatment with Exenatide as compared to treatment with once daily          basal insulin (Lantus).        4. Treatment will result in no improvement in endothelial-independent vasodilation, as          measured by a response to TNG, as compared to the control group, who will be treated          with Lantus insulin to achieve comparable HbA1c levels.        5. Treatment with Exenatide, compared with treatment with Lantus, will result in a          reduction in various plasma markers of inflammation (CRP, TNFA, IL6), endothelial          activation (ICAM, VCAM, endothelin 1), fibrinolysis (PAI-1 protein, PAI-1 activity), and          oxidative stress (FOX2).   "
191672|NCT00353873|"     This study will compare two treatment strategies (doubling the dose of inhaled steroids or     adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not     controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one     inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.   "
191673|NCT00353886|"     The specific aim of this study is to determine if in utero exposure produces differential     antiepileptic drug (AED) effects on subsequent cognitive abilities and behavioral     abnormalities in children   "
191674|NCT00353899|"     This study will examine ways to establish and standardize normal measurements for children,     specific to gender, age, and body surface, when using magnetic resonance imaging (MRI). MRI,     which was introduced in the 1980s, is being used more frequently for children. In this study,     researchers seek to understand how a child's heart is different from that of an adult, when     an MRI is used for tests. More children with congenital heart disease are living longer.     Researchers are looking for a better way to assess their cardiac anatomy and function, and to     compare findings with normal function.      Patients ages 8 to 21 in good health and who do not smoke may be eligible for this study.     There will be a blood or urine test to check for pregnancy in female volunteers who have     begun menstruating or who are over age 12. Pregnancy test results must be negative for those     patients to stay in the study. The MRI technique uses a strong magnetic field and radio waves     to obtain images of body organs and tissues. For that procedure, patients will lie still on a     table that slides into the enclosed tunnel of the scanner. They will be in the scanner from     20 to 60 minutes. As the scanner takes pictures, patients will hear knocking or beeping     sounds, and they will wear earplugs to reduce the noise. Patients will be able to communicate     with the MRI staff at all times during the scan. At any time, patients or their parents may     ask that the patients be moved out of the machine. If they would like, patients can bring a     music CD or listen to a radio station through headphones. Some MRI techniques require     monitoring while the patient is undergoing the scan. For monitoring of the heart, an     electrocardiogram (EKG) will be performed to make sure that the heart rhythm is normal and     that heart disease is not present. Patients may be asked to wear adhesive patches that are     attached to wires of the EKG machine on their chests. To monitor breathing, patients may be     asked to wear a rubber belt that stretches as they take a breath. So that the best quality     images are produced, patients may be asked to hold their breath for about 15 seconds.      During the MRI scan, patients may experience peripheral nerve stimulation, usually     experienced as a muscle twitch. It is caused by rapid switching of magnetic fields and is not     serious. Patients who feel a muscle twitch should report that sensation to the person     performing the scan. It is possible, though unlikely, for a painful sensation to result from     nerve stimulation. Patients should immediately report if they have pain so that the scan can     be stopped.   "
191675|NCT00353912|"     The purpose of this study is to evaluate the blood pressure lowering effects of a     valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of     Black stage II hypertensive patients (MSSBP ≥ 160 mmHg).   "
191676|NCT00353925|"     The purpose of this study is to learn if kinase, a protein found in the heart, contributes to     thickening of the heart muscle in people with high blood pressure.      A protein called myosin causes the heart to contract and relax. It is thought that kinase     changes myosin to make it work better at different heart rates. This study will try to     determine if, in some people with high blood pressure, the different forms of this protein     cause changes in the heart. If the protein affects the size of the heart, it might be     possible to use it to improve heart function after an injury, such as a heart attack.      African-Americans with high blood pressure will be eligible for this study. Current data show     that of almost 900 multi-ethnic individuals, the particular form of kinase under study in     this project is found exclusively in the African-American population. Study participants will     have two tubes of blood drawn for DNA testing to determine what form of kinase is present. An     electrocardiogram will also be done if a recent one is not available. Some people may also     have an echocardiogram, an ultrasound test to image the heart.   "
191677|NCT00353938|"     This study will look at the safety and efficacy of MDMA-assisted psychotherapy in people with     posttraumatic stress disorder (PTSD).   "
191678|NCT00353951|"     The overall objective of GRACE is to combat the resistance of drugs that kill bacteria and     other germs (antimicrobial) through integrating centres of research excellence and using the     study of the entire DNA in a cell (genomics) to most appropriately investigate and manage     community-acquired LRTI.      Grace-01 is the first study to be undertaken as part of GRACE and the aims of this study are     to describe the presentation, diagnosis, investigation, management and outcomes for people     with cough / chest infection in general medical practice in 13 primary care networks in 12     countries in Europe.   "
191679|NCT00353964|"     The purpose of this study is to evaluate the safety and effectiveness of three concentrations     of rEV131, a new investigational anti-inflammatory agent, compared to placebo (an inactive     substance) and an FDA approved anti-inflammatory agent in patients with ocular inflammation     who have undergone cataract extraction with intra-ocular lens implantation.   "
191735|NCT00348517|"     The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783     when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of     dry eye patients.   "
191680|NCT00353977|"     This study will evaluate the safety and effectiveness of a new vaccine, ALVAC-pp65, in     boosting immunity to cytomegalovirus (CMV) infection in stem cell transplant donors. CMV is a     member of the herpesvirus group, which includes herpes simplex virus types 1 and 2,     varicella-zoster virus (which causes chickenpox), and Epstein-Barr virus (which causes     infectious mononucleosis). Most adults are infected with CMV, but a healthy immune system     keeps the virus in check, so that it does not cause harm. In people with a weakened immune     system, such as transplant recipients, the virus can become reactivated. Medications for     treating the infection may cause low blood counts and kidney damage, and, in some cases, the     virus may cause death. The ALVAC-pp65 vaccine is intended to improve immunity against CMV in     stem cell donors and thereby prevent its reactivation in recipients. It is made from a virus     that ordinarily infects canaries. The virus is weakened so that it cannot infect the person     who receives it, and it is modified to carry a copy of a CMV gene called pp65. This gene     instructs cells to make CMV proteins that the vaccine recipient's immune system can produce     antibodies to, thus conferring immunity to the disease.      Persons 18 years of age or older who are scheduled to donate stem cells for a patient in an     NIH protocol and who are not allergic to eggs, egg products, or other vaccines, may be     eligible for this study. Candidates are screened with a medical history, physical     examination, and blood tests.      Participants receive three vaccinations one week apart beginning at least 3 weeks before the     scheduled stem cell donation. They are observed for 30 minutes after each vaccination to look     for any immediate side effects of the vaccine. Approximately 3 tablespoons of blood are drawn     before each vaccination and 1 week after the last vaccination to evaluate vaccine safety.     Blood samples are also collected at the screening evaluation, 3 weeks after the start of     vaccination, and 3 months after the last vaccination to check for CMV immunity.      Participants keep a diary, recording any reactions to the vaccine and any change in     medications. They are contacted by telephone for follow-up 3 months after the last     vaccination to report any additional symptoms.   "
191681|NCT00353990|"     A study of the bioavailability of insulin after infusion in the duodenum in healthy     volunteers.   "
191682|NCT00354003|"     The overall goal of the study is to evaluate how research participants in Parkinson Disease     studies that include brain imaging with a dopamine transporter ligand choose to receive the     imaging data and what is the impact of the imaging data information on the management of     their symptoms.   "
191683|NCT00354016|"     Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines     are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for     Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the     newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly     and elderly subjects (CPMP/BWP/214/96).   "
191684|NCT00354029|"     The purpose of this study is to determine whether the use of perioperative intravenous S (+)     ketamine reduces the amount and degree of postoperative pain.      Furthermore the purpose of this study is to determine whether the use of perioperative     intravenous S (+) ketamine effects cognitive function in the early postoperative period.   "
191685|NCT00354042|"     This study is designed to look at the safety aspects and effects of repeat inhaled doses of     GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive     Pulmonary Disease(COPD).   "
191686|NCT00354068|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving imatinib mesylate together with temozolomide may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate     when given together with temozolomide in treating patients with malignant glioma.   "
191687|NCT00354081|"     PURPOSE OF STUDY Observational studies have demonstrated that elevated levels of plasma total     homocysteine is a risk factor for cardiovascular disease. The purpose of this trial is to     evaluate the clinical effects of homocysteine lowering treatment with B vitamins during 3-5     years follow-up of patients undergoing cardiac catheterization for suspected coronary artery     disease (CAD). Special attention will be given to complication rates among patients needing     subsequent percutaneous transluminal coronary angioplasty (PCI) or coronary artery by-pass     grafting (CABG).      HYPOTHESIS The primary hypothesis of this study is that, among patients with CAD, a daily     supplement with B vitamins will reduce the risk for cardiovascular mortality and serious     cardiovascular events with at least 20%. The secondary hypothesis of this study is that,     among patients with CAD, a daily supplement with B vitamins will reduce the risk for total     mortality, coronary events, cerebrovascular events and other cardiovascular events. The     hypothesis will be tested for an effect of any of the treatments (folic acid / vitamin B12 or     B6), and the effect will be evaluated according to initial total homocysteine levels and B     vitamin levels as well as to the change in these levels after 1 and 6 months. The sample size     has been calculated to 3088 patients using a two-sided chi-square test with significance 0.05     and at an 80% power level, presumed event rate of 22% over 4 years, and event rate reduction     of 20%, adjusted for non-compliance/drop-out of 20%.      STUDY DESIGN This is a controlled, double-blind two-centre trial with 3090 included men and     women who underwent coronary angiography at Haukeland University Hospital or Stavanger     University Hospital between April 1999 and April 2004. At baseline about 1300 patients     underwent PCI and 600 underwent CABG. The patients were randomized into 4 groups in a 2 x 2     factorial design to receive one of the following four treatments: A, folic acid 0.8 mg plus     vitamin B12 0.4 mg and vitamin B6 40 mg per day; B, folic acid 0.8 mg plus vitamin B12 0.4 mg     per day; C, vitamin B6 40 mg per day; D, placebo. The active drug and the placebo tablets had     identical appearance and taste. Treatment was started as soon as the patients were randomized     after the coronary angiography procedure. The patients have been undergoing interviews,     clinical examination and blood-sampling at baseline, at follow-up after 1 month and 1 year,     and at a final study visit. In addition, information on dietary habits was obtained from 2400     patients at baseline. Among 350 patients that have undergone PCI at baseline, a full clinical     examination, blood sampling and repeat coronary angiography to assess re-stenosis has been     performed about 9 (6-12) months after the PCI procedure. For these patients, angiograms     suitable for quantitative coronary angiography (QCA) analysis have been obtained at the     baseline and follow-up invasive procedures.      The follow-up was terminated ahead of schedule in October 2005 due to lack of compliance of     the participants caused by media reports from the NORVIT study (NCT00266487) on potential     increased cancer risk associated by B vitamin supplementation. The patients had then been     followed for 1.5 - 5 years.      STUDY END POINTS Primary clinical endpoints during follow-up are all cause death, non-fatal     acute myocardial infarction, acute hospitalization for unstable angina and non-fatal     thromboembolic stroke (infarction). Secondary endpoints are fatal and non-fatal acute     myocardial infarction (including procedure related myocardial infarction), acute     hospitalization for angina, stable angina with angiographic verified progression, myocardial     revascularization, fatal and non-fatal thromboembolic stroke.   "
191688|NCT00354094|"     The purpose of this study is to assess the long term (up to 2 years) safety and tolerability     of [S,S]-Reboxetine in patients with pain after shingles.   "
191689|NCT00354107|"     This phase I/II trial is studying the side effects and best dose of SGN-30 when given     together with ifosfamide, carboplatin, and etoposide and to see how well they work in     treating young patients with recurrent anaplastic large cell lymphoma. Drugs used in     chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as SGN-30, can block cancer growth in different ways. Some block     the ability of cancer cells to grow and spread. Others find cancer cells and help kill them     or carry cancer-killing substances to them.   "
191690|NCT00354120|"     The purpose of this study is to compare Reduced Intensity Conditioning protocols containing     either Thymoglobuline or Alemtuzumab in patients undergoing allogeneic transplant from     voluntary unrelated donors.   "
191691|NCT00354133|"     Parkinsons' disease is one of the most disabling chronic neurological diseases. It can be     treated sufficiently until motor complications with fluctuations of mobility and dyskinesias     develop. The quality of life and the social and occupational functioning is relentlessly     deteriorating with longer disease duration once the complications of conservative therapy     develop. High-frequency stimulation of the subthalamic nucleus especially improves the motor     complications of Parkinson's disease and preliminary data suggest that also the quality of     life and psychosocial handicap are improved. So far this therapy is only used for patients     which have already undergone personal, professional and social degradation due to motor     complications of the disease. The aim of this study is to assess the use of this therapy in     earlier stages of the disease, when motor complications have just developed and before     patients are significantly affected in their social and occupational functioning.   "
191692|NCT00354146|"     The purpose of this study is to evaluate the effectiveness (response rate) and safety of     tipifarnib in patients with refractory or relapsed AML.   "
191693|NCT00354159|"     The purpose of this clinical research study is to evaluate the safety and effectiveness of     the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with     an implantable cardioverter defibrillator (ICD). The investigational IHM has the ability to     record and report the force with which the heart pumps blood (heart pressures). When combined     with the ICD, the device has the additional ability to send a strong electrical impulse, or     shock, to the heart when it detects dangerously fast heartbeats to return it to a normal     rhythm. The IHM and IHM/ICD are implanted surgically just under the skin in the upper chest     area. This study will also determine how doctors use the information related to heart     pressures in the management of heart failure.   "
191736|NCT00348530|"     Accumulated clinical and experimental data suggest that dysfunctional coronary     microcirculation plays a pivotal role in the progression of heart failure despite an optimal     therapy used. Therefore, we hypothesize that improvement in microvascular function by calcium     antagonist, verapamil may result in additional clinical benefit. Thus, the aim of this study     is to compare the effect of treatment with verapamil or carvedilol on long-term outcomes in     stable, chronic heart failure secondary to non-ischemic cardiomyopathy.   "
191694|NCT00354172|"     RATIONALE: Giving chemotherapy, natural killer cells, aldesleukin, and total-body irradiation     before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal     cells and cancer cells. It also helps stop the patient's immune system from rejecting the     donor's stem cells. When the healthy stem cells from a donor are infused into the patient     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,     and platelets. Sometimes the transplanted cells from a donor can make an immune response     against the body's normal cells. Giving cyclosporine, mycophenolate mofetil, and     methylprednisolone before and after transplant may stop this from happening.      PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide     together with total-body irradiation followed by donor umbilical cord blood natural killer     cells, aldesleukin, and umbilical cord blood transplant works in treating patients with     refractory hematologic cancer or other diseases.   "
191695|NCT00354185|"     This phase I trial is studying the side effects and best dose of giving PDX101 together with     17-AAG in treating patients with metastatic or unresectable solid tumors or lymphoma. PDX101     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth     and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as     17-N-allylamino-17-demethoxygeldanamycin (17-AAG), work in different ways to stop the growth     of cancer cells, either by killing the cells or by stopping them from dividing. Giving PXD101     together with 17-AAG may kill more cancer cells.   "
192060|NCT00362141|"     The purpose of this study is to determine whether levetiracetam is safe and well tolerated by     patients while suffering a status epilepticus. Levetiracetam is added to the standard     treatment of patients with this disease.   "
191696|NCT00354198|"     We have recently demonstrated that pentoxifylline (PTX) has the potential to treat severe     glomerular inflammation in a rat model of accelerated anti-glomerular basement membrane (GBM)     glomerulonephritis. This study aims to investigate the therapeutic effects of combined PTX     and conventional immunosuppressive regimens on patients with rapidly progressive     glomerulonephritis.   "
191697|NCT00354211|"     The purpose of this study is to evaluate if the continuous availability of minimally invasive     cardiac output data during treatment in the intensive care unit (ICU) for hemodynamic     instability, in comparison to standard of care will shorten the time needed to stabilize the     patient.      The researchers hypothesize that early detection of instability improves the prognosis and     treatment outcome of emergency intensive care patients with hemodynamic instability.   "
191698|NCT00354224|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving capecitabine together with     oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic     stomach cancer.   "
191699|NCT00354237|"     The aim of the DARE study is to see whether strict glycemic control during cardiac     rehabilitation may ameliorate the improvement of exercise capacities (VO2 peak, peak     workload, ventilatory threshold)in patients with type 2 diabetes with coronary artery     disease.   "
191700|NCT00354250|"     This phase II trial is studying how well ispinesib works in treating patients with metastatic     or unresectable kidney cancer. Ispinesib may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth.   "
191701|NCT00354263|"     This study is a single centre, single blind, placebo (step 1) or reference (step 2)     randomised study. Healthy young male volunteers will receive single ascending dose of IMP321     in each step (4 doses tested: 3, 10, 30 and 100 µg). In step 1, IMP321 will be given alone     and tested versus placebo (physiological saline). In step 2, the association IMP321 +     Agrippal (commercially available flu vaccine) will be tested versus Agrippal alone.   "
191702|NCT00354276|"     RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving VNP40101M followed by cytarabine may kill more cancer cells.      PURPOSE: This phase II trial is studying how well VNP40101M followed by cytarabine works in     treating older patients with acute myeloid leukemia.   "
191703|NCT00354302|"     RATIONALE: Learning about the effect of exemestane and anastrozole on bone mineral density in     postmenopausal women with primary breast cancer may help plan treatment, decrease the risk of     broken bones, and help patients live more comfortably.      PURPOSE: This phase III trial is studying bone mineral density in postmenopausal women with     primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27.   "
191704|NCT00354315|"     The objective of this project is to evaluate the feasibility of a larger randomized trial of     the efficacy of DECISION+, a continuous professional development program integrating multiple     components, to promote shared decision making concerning drug prescription.   "
191705|NCT00354328|"     This study will examine the relationship between certain measures of heart function and     exercise capacity in patients with hypertrophic cardiomyopathy (HCM).      Patients who participated in NHLBI studies 01-H-0006 (Double Blind Placebo-Controlled Study     of Pirfenidone - A Novel Anti-Fibrotic Drug - in Symptomatic Patients with Hypertrophic     Cardiomyopathy Associated with Left Ventricular Diastolic Dysfunction) and 96-H-0144     (Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin-Converting Enzyme     Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced     Left Ventricular Diastolic Dysfunction) are eligible for this study. Data from     echocardiograms and measures of left ventricular pressure obtained from patients in those     studies will be analyzed in the current study to assess their influence on exercise capacity.     No additional tests, treatments or other procedures are required.      Information from this study may help in the development of improved drug treatments for HCM.   "
191706|NCT00354341|"     This study will assess the effect of anemia correction with NeoRecormon on cardiac structure     and function in patients with early diabetic nephropathy. The anticipated time on study     treatment is 1-2 years and the target sample size is 100-500 individuals.   "
191737|NCT00348543|"     To study the effect of mild laser treatment on the incidence of exudative complications in     soft drusen maculopathy. We hypothesise that mild laser treatment causing a proliferation of     the retinal pigment epithelium and enhancing the capacity of clearing drusen material from     Bruch's membrane.   "
191944|NCT00358956|"     This will be a Phase II, open label study to establish the effect of once-daily oral doses of     ZD6474 100mg in subjects with locally advanced or metastatic hereditary medullary thyroid     cancer in whom no standard therapeutic option is available.   "
191707|NCT00354354|"     Hypothesis: The reduction of dynamic hyperinflation and its negative effects on the     respiratory system following a bronchodilator could lead to an improvement of cardiac     function in terms of increased cardiac output. This may enhance oxygen delivery to the     exercising muscles in COPD patients. Bronchodilator administration may also have an indirect     effect on V'O2 kinetics via its action on cardiovascular and pulmonary variables.      Objectives:        1. To evaluate the effects of a bronchodilators on V'E , V'CO2 , and V'O2 kinetics in COPD          during constant work-rate cycle exercise, and to evaluate whether bronchodilators will          accelerate, indirectly, phase 2 kinetics (usually slower in COPD patients than normal          subjects) and shorten t for V'E, V'CO2 , and V'O2 and shorten half-times for HR and O2          pulse, thus showing an improvement of oxygen transport to the peripheral active muscles.        2. To determine the impact of a bronchodilator-induced reduction in dynamic hyperinflation,          and its effects on cardiovascular and pulmonary function, on exercise limitation in          COPD.   "
191708|NCT00354367|"     To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's     disease subjects with active draining fistulas.   "
191709|NCT00354380|"     The primary objective of this trial is to study the safety of the combination methylene blue     (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to     the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of     MB-AS and MB-AQ.   "
191710|NCT00354393|"     RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinorelbine, and cisplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller     and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses     high-energy x-rays to kill tumor cells. Cisplatin may also make tumor cells more sensitive to     radiation therapy. Giving chemotherapy and radiation therapy after surgery may kill any tumor     cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or     without surgery and chemoradiotherapy works in treating patients with malignant pleural     mesothelioma.   "
191711|NCT00354406|"     Abciximab has been demonstrated to improve outcome when administered during primary     angioplasty in patients with acute myocardial infarction. The Primary Objective of the study     is to demonstrate that early (before transportation form remote hospital to the cath lab)     abciximab administration during acute myocardial infarction reduces infarct size as compared     with late (just prior to PCI) abciximab administration, as measured by delayed enhancement     magnetic resonance (MR) at 6 months.   "
191712|NCT00354419|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood     stem cell transplant helps stop the growth of abnormal cells. It also helps stop the     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells     from a donor are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells     from a donor can make an immune response against the body's normal cells. Giving cyclosporine     and mycophenolate mofetil before and after transplant may stop this from happening.      PURPOSE: This phase I trial is studying the side effects and best dose of total-body     irradiation when given together with cyclophosphamide and antithymocyte globulin in treating     patients with severe aplastic anemia undergoing umbilical cord blood transplant.   "
191713|NCT00354432|"     RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients     receiving hormone therapy for prostate cancer. It is not yet known whether soy     protein/isoflavones are more effective than venlafaxine when given together or with a placebo     in treating hot flashes.      PURPOSE: This randomized phase III trial is studying soy protein/isoflavones and venlafaxine     to compare how well they work when given together or with a placebo in treating hot flashes     in patients receiving hormone therapy for prostate cancer.   "
191714|NCT00354445|"     The purpose of this study is to explore the safety and efficacy of Macugen given as     maintenance therapy in patients who have had initial success with another AMD treatment.     Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.   "
191715|NCT00354458|"     The study is being conducted to examine whether KW-3902IV will result in greater improvement     in signs and symptoms of heart failure, with less treatment failure than standard therapy,     when it is added to IV loop diuretics in subjects with acute heart failure syndrome and renal     impairment.   "
191716|NCT00354471|"     This study will evaluate the safety, efficacy , quality of life and patient satisfaction of     uterine artery embolization for the treatment of symptomatic uterine fibroids. It will     provide useful information in the development od guidelines in patient selection, procedural     management and subsequent follow up.   "
191717|NCT00354484|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45     compared to the current standard of care in postpartum patients.   "
191718|NCT00354497|"     RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to     treat. The amount of heterocyclic amines in the diet may affect prostate cancer screening     results and the risk of prostate cancer.      PURPOSE: This phase II trial is studying prostate cancer screening and dietary heterocyclic     amines in African American men.   "
191719|NCT00354510|"     The purpose of this study is to investigate the clinical efficacy of 3% (w/w) GW842470X cream     applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema     Area Severity Index (EASI) assessment of disease severity and to investigate the safety of     and tolerability of 3% GW842470X cream on diseased skin of adult patients.   "
191720|NCT00354523|"     Objectives:      Primary objectives:      To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate,     capecitabine, and dacarbazine in patients with solid tumors.      To determine the overall tumor response rate to imatinib mesylate in combination with     capecitabine and dacarbazine as first line and second line therapy in advanced metastatic     medullary thyroid carcinoma.      To determine the tolerability (toxicity) of this regimen.      Secondary objectives:      To determine the median overall survival (OS) and time to progression (TTP) for patients     treated with this combination.   "
192176|NCT00363701|"     The primary purpose of the study is to determine the effect of esomeprazole compared to     placebo in patients from general practice who have previously been treated with     proton-pump-inhibitors (PPI) and who have no upper endoscopic findings.   "
191722|NCT00354549|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and     gemcitabine at disease progression may be an effective treatment for non-small cell lung     cancer.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib     followed by cisplatin or carboplatin and gemcitabine works in treating patients with newly     diagnosed or recurrent stage IIIB or stage IV non-small cell lung cancer.   "
191723|NCT00354562|"     To determine the efficacy of ABT-751 when administered in combination with standard docetaxel     in subjects with advanced or metastatic NSCLC.   "
191724|NCT00354575|"     The purpose of our study is to improve the problem of constipation and increase the quality     of long-term care by the regimen of Chinese herb prescribed by professional doctors of     Chinese medicine.   "
191725|NCT00354588|"     1. Cardiovascular risk is high in patients with renal failure.        2. Cross-sectional studies have indicated a relationship between arterial stiffness and          renal function. However, there are no prospective longitudinal studies in the          literature.        3. In dialysis patients, arterial stiffness as well as wave reflections, predict mortality.          However, there are no data on patients with mild-to-moderate renal impairment available.        4. Therefore, we designed a study to test the hypothesis that: a) measures of arterial          stiffness and wave reflections predict the progression of renal impairment in patients          with mild-to-moderate renal failure; and b) measures of arterial stiffness and wave          reflections predict cardiovascular events in patients with mild-to-moderate renal          failure   "
191726|NCT00354601|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving docetaxel together with carboplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel together with capecitabine     works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian     tube cancer, or peritoneal cavity cancer.   "
191727|NCT00354614|"     The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity     of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a     correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic     PSG and AL.   "
191728|NCT00354627|"     The purpose of this study is to provide early access of TMC125 to HIV-1 infected patients who     have failed multiple antiretroviral (ARV) regimens. Information on safety and tolerability     aspects of TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with     limited treatment options will be assessed. Available data regarding the effectiveness of the     drug will also be collected. To be eligible, patients should be failing their current ARV     regimen or be on a treatment interruption, should have previously received 2 different     protease inhibitor (PI) containing regimens and be at least 3-class experienced (protease     inhibitors [PI], nucleoside/tide reverse transcriptase inhibitors [N[t]RTIs] and     non-nucleoside reverse transcriptase inhibitors [NNRTIs]) or at least 2-class experienced     (PIs and N[t]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination     with an investigator-selected background of additional ARVs from the list of allowed     medications.   "
191729|NCT00354640|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of simvastatin and anastrozole may stop cancer from forming, growing,     or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high     risk of breast cancer.      PURPOSE: This phase II trial is studying how well giving simvastatin together with     anastrozole works in treating postmenopausal women with invasive breast cancer, ductal     carcinoma in situ, or a high risk of breast cancer.   "
191730|NCT00354653|"     The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic     hepatitis has been well established.The evidence in HBeAg negative patients is limited.     Limited sustained response was observed post-treatment following a one year treatment period.     Whether these results can be applied to patients in Iran is uncertain. This study is     therefore intended to further assess the efficacy profile after two years of open treatment     in the adult Iranian population.   "
191731|NCT00354666|"     This study was designed to test safety aspects and effects on lung function of a new dry     powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with     previous studies which have only used inhalation of the drug as a vapour.   "
191732|NCT00354679|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others     interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the     growth of esophageal cancer by blocking blood flow to the tumor. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving chemotherapy and monoclonal antibody therapy     together with radiation therapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill     any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving irinotecan, cisplatin, and     bevacizumab together with radiation therapy followed by surgery and bevacizumab works in     treating patients with locally advanced esophageal cancer.   "
191733|NCT00348491|"     This study will assess the safety and efficacy of lumiracoxib 400 mg in relieving moderate to     severe post-dental surgery pain, compared to both placebo and celecoxib 400 mg.   "
191734|NCT00348504|"     The primary objective of the study is to compare the efficacy of levosimendan and dobutamine     on all-cause mortality in the 180 days following randomization.   "
191738|NCT00348556|"     The objective of this study is to determine the safety and effectiveness of intrarenal     administration of brain natriuretic peptide (BNP) in improving renal function as measured by     glomerular filtration rate (GFR) and sodium excretion in patients hospitalized with acute     congestive heart failure (CHF) and deterioration of kidney function (cardiorenal syndrome).   "
191739|NCT00348569|"     To compare computed tomography (CT) images (pictures) of the coronary arteries using the     General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients with     typical or atypical chest pain suspected of coronary artery disease (CAD).   "
191740|NCT00348582|"     The purpose of this study is to compare the clinical outcomes, safety and efficacy in     patients randomized to receive either ketorolac or nepafanac following cataract surgery.   "
191756|NCT00348790|"     RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor     and by blocking some of the enzymes needed for cell growth.      PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with     recurrent or progressive meningioma.   "
191757|NCT00348803|"     As a pulmonary hypertension center, we have created a database that prospectively tracks     patients with different forms of secondary pulmonary hypertension. Records include genetic     analysis, and clinical and hemodynamic profiles.   "
191741|NCT00348595|"     The primary objectives of the study are:        -  To evaluate feasibility, safety and tolerance of 6 months administration of Revlimid at          5mg/day and 25mg/day, given orally in subjects with prostate cancer with evidence of          biochemical relapse (M0) following local treatment (i.e., surgery or radiation).        -  To assess the rate of PSA (prostatic specific antigen) progression at 6 months after          treatment with 5mg/day and 25mg/day of Revlimid (CC-5013) in patients with evidence of          biochemical relapse after local therapy.      The secondary objectives of the study are:        -  To provide preliminary assessments on the effects of Revlimid (CC-5013) at 5mg/day and          25mg/day on various PSA constructs in the subject population (i.e., PSADT [Prostatic          Specific Antigen Doubling Time] and PSA slope) by comparing pre and post treatment          patterns in each arm.        -  To evaluate preliminary pharmacodynamic correlations between serum revlimid          concentrations and toxicity, PSA constructs and other evidence of disease progression.   "
191742|NCT00348608|"     CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses     x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins     throughout the body VISIPAQUE™ will be given through a vein in the arm before having the CTA     scan of the heart arteries. The pictures it produces of the heart and its blood vessels will     be reviewed and compared to those obtained during the catheter-based coronary angiography to     see if the CTA shows the same blockages.   "
191743|NCT00348621|"     The purpose of this clinical trial is to determine if interventions within the nursing home     to restore vision, or cope with visual loss, in residents with visual impairment result in     improvement or less decline in mobility scores, and socialization scores, compared to     residents with visual impairment in nursing homes with no such intervention. The     investigators hypothesized that nursing home residents with visual loss who receive cataract     surgery, or refractive correction, or low vision aids would have have better socialization     scores and mobility scores at 6 months and 12 months compared to nursing home residents with     visual impairment who are advised to seek services, but have no specific program.   "
191744|NCT00348634|"     This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients     over 65 years with chronic constipation.   "
191745|NCT00348647|"     Overuse injuries are a major concern for physical active individuals. Study hypothesis is     that an exercise programme based on known intrinsic risk factors can prevent overuse injuries     in soldiers undergoing basic military training.   "
191746|NCT00348660|"     The first part of this study will investigate the incidence of Hepatitis C in pregnant women     attending an inner city health clinic in downtown Toronto. All women attending the clinic who     give their consent to participate will be screened by a standardized questionnaire as well as     by a blood test. Blood testing will tell us how many of these women have Hepatitis C. We will     then be able to compare the specificities and sensitivities of targeted screening (risk     behaviour questionnaires) versus universal screening (blood tests).      In the second part of the study we will follow the pregnancies of those women who were     identified as Hepatitis C positive on the screening test. Follow- up will include liver     enzymes and viral load quantifications (amounts) in the first, second and third trimesters as     well as during delivery and six weeks post-partum. We will also document pregnancy outcomes     with regard to type of delivery and complications. Pregnancy outcomes will be compared to an     age and race matched group of women who do not have Hepatitis C.      Study Hypothesis:      We expect a higher incidence of Hepatitis C in this inner city population compared to the     general Canadian pregnant population (0.9%). We predict an HCV seroprevalence (rate) ranging     between 2-6% in this population and we also predict that targeted screening by standardized     questionnaire will fail to identify half of the Hepatitis C positive cases.      By following this group of Hepatitis C positive women through pregnancy, we expect to lend     further support to previous data showing significant decrease and/or normalization of serum     transaminases as well as significant increase in HCV viral load by third trimester. We also     expect to see no significant differences in pregnancy outcomes or obstetrical complications     between HCV positive women and the HCV negative women.   "
191747|NCT00348673|"     A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load     response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the     dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability     of UK-453,061 in asymptomatic HIV infected subjects.   "
191748|NCT00348686|"     The purpose of this study is to investigate effect of candesartan based therapy on percent     change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left     ventricular hypertrophy.   "
191749|NCT00348699|"     This phase I trial studies the side effects and best dose of AFP464 in treating patients with     metastatic or refractory solid tumors that cannot be removed by surgery. Drugs used in     chemotherapy, such as AFP464, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing.   "
191750|NCT00348712|"     This trial is conducted in Europe.      The aim of this research study is to compare the efficacy of adding inhaled preprandial     insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type     2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin     antibodies and side effects).   "
191751|NCT00348725|"     The primary objective was to assess the acceptability of a 4-week treatment of 4 new     fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and     dyslipidemia.   "
191753|NCT00348751|"     Indirect evidence show alerting physicians with clinical decision support systems (CDSS) seem     to change behaviour more than requiring users to actively initiate the system. However,     randomized trials comparing these methods in a clinical setting are lacking. In this study we     compare the effect of Alerting physicians with a CDSS or actively requiring initiation of     CDSS on the adherence of Dutch general practitioners to the Cholesterol guideline of the     Dutch college of General Practitioners.   "
191754|NCT00348764|"     To evaluate the efficacy and the tolerance of echoguided sclerotherapy using Lauromacrogol     400 foam for the treatment of Great Saphenous Vein (GSV) insufficiency. A comparative study     of 3% versus 1% Lauromacrogol 400 foam.   "
191755|NCT00348777|"     The main objective of this study is to evaluate the therapeutic effect of a thermal treatment     on gonarthrosis, with an increase of the number of patients presenting a clinically     significant improvement.   "
191758|NCT00348816|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make     tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation     therapy and prednisone after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation     therapy and prednisone works in treating patients who have undergone surgery for prostate     cancer.   "
191759|NCT00348829|"     The aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients     with secondary mitral insufficiency and CHF.        1. Identification of hemodynamic parameters as predictor for a successful mitral valve          reconstruction in CHF patients.        2. Collection of clinical factors for the assessment of the postoperative course after          mitral valve reconstruction in CHF patient.   "
191760|NCT00348842|"     NDV is a virus tht is harmful in chicken, but harmless in man. There are 2 major sub-strains     of NDV, one oncolytic and one non-oncolytic. Oncolytic NDV (MTH-68H) preferentially homes and     replicates in cancer cells and therefore, administration of NDV intravenously or     preferentially intra-tumor, either by direct injection or by injection into an afferent     artery results in direct lysis of tumor cells. NDV activates apoptotic mechanism in cancer     cells and thus, results in natural cell death.      Both oncolytic and non-oncolytic NDV were used clinically in hundreds of patients with     different types of cancer worldwide. NDV were proved harmless in man. Clinical studies were     done for more than a decade and the efficacy of NDV was documented on pre-clinical animals     models as well as in man.      For a large number of patients with metastatic cancer and chemotherapy resistant     hematological malignances, no cure can be provided by conventional anti-cancer modalities,     new treatment options are urgently indicated. The goal of the study is to use NDV, in order     to provide such treatment for patients in need.   "
191761|NCT00348855|"     Observational studies performed in France and abroad in hypertensive patients at high     cardiovascular risk have shown a wide gap between the therapeutic targets reached in     ambulatory patients and those set by guidelines. In primary prevention, in hypertensive     patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1)     the ignorance of the validated therapeutic targets and strategies, 2) the absence of global     cardiovascular risk management, 3) the usual ambulatory medical practice, which is not     adapted to a global cardiovascular prevention approach.      Objectives Principal. To demonstrate that a series of 5 specific prevention consultations     over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to     reach the goals set by guidelines with no deterioration of their quality of life compared     with no particular intervention.      Method Pragmatic, cluster-randomised controlled trial. At least 1904 high cardiovascular risk     hypertensive patients will be included and followed up during two years by 268 teaching     general practitioners from 23 regional teaching colleges. The regional teaching colleges will     be randomised to avoid a contamination bias. The study will be coordinated by local     coordinators at the college level.      Intervention In the intervention group, the investigators will have training, information,     and feed back regarding the management of high risk hypertensive patients. The training will     concern the targets to be reached, therapeutic strategies recommended by the AFSSAPS/HAS, and     scientific data. The investigators will have an easy guide that can be used during     consultations, and will be informed about tobacco withdrawal programs and education for     improving diet, exercise and compliance.      In the control group, investigators will care for their patients as usual. End points Main:     number of patients who reach all the therapeutic targets defined by the guidelines in the     total study population, in the sub-group of patients with hypertension, but free of type-2     diabetes (T2D), and in the sub-group with hypertension and DT2.      Secondary: number of targets reached by the patients, changes in level of blood pressure,     LDL-cholesterol, HbA1c, tobacco consumption, and use of aspirin if needed in the total     population and its two subgroups, estimated cardiovascular risk, quality of life.   "
191762|NCT00348868|"     A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction     counseling with buprenorphine/naloxone to enhanced motivational drug counseling with     buprenorphine/naloxone for the treatment for opioid addiction in an integrated and     nonintegrated HIV care setting.   "
191763|NCT00348881|"     This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T     combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6,     10, and 14 weeks of age.   "
191764|NCT00348894|"     The purpose of this study is to assess the long-term safety and tolerability of     [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy   "
191765|NCT00348907|"     The main objective of this study is to demonstrate that hydrotherapy in a specific place can     reduce the risk of post-thrombotic syndrome.   "
191780|NCT00354744|"     RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide,     etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination     chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy     together with radiation therapy works in treating patients with newly diagnosed metastatic     rhabdomyosarcoma or ectomesenchymoma.   "
191795|NCT00354952|"     Resistance to antibiotics is a major public-health problem and studies linking antibiotic use     and resistance have shown an association not a causal effect. Utilizing the newer macrolides,     azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we     investigated the direct impact of antibiotic exposure on resistance at the individual level.   "
191766|NCT00348920|"     This study is looking at the effects of high spinal anesthesia (also known as total spinal     anesthesia) combined with general anesthesia versus general anesthesia alone on the     following:      Stress response: Patients undergoing aortic valve replacement surgery have a large incision     and a complex operation where they must be placed on the heart-lung machine. The body reacts     to the heart-lung machine, increasing the stress response.      High spinal anesthesia using local anesthetics when combined with general anesthesia has been     shown to block some of the stress response to surgery and the response to the heart-lung     machine. This study will examine if blood levels of stress hormones and also inflammatory     mediators can be lowered with the use of high spinal anesthesia.      Heart function: High spinal anesthesia in combination with general anesthesia may help the     heart work better when there is a narrowed valve (aortic stenosis). The heart may also have     improved ability to pump blood with this anesthetic technique.      Lung function and post-operative pain control: After surgery, patients often have pain which     prevents them from taking deep breaths and coughing. This can lead to pneumonia. This study     will also examine if the post-operative pain relief provided by spinal morphine (given     together with the spinal anesthetic) can provide any better pain control following surgery.     By doing this, we want to see if patients can take bigger breaths after their surgery when     spinal morphine is used, and try to prevent the complications that occur if patients are not     able to breath deeply after surgery.   "
191769|NCT00348959|"     The 'Open Window' Study is a prospective longitudinal study using a 4 group randomised     control trial design to evaluate the psychological effect of 'Open Window' on the     consequences of long term isolation on patients undergoing stem cell transplantation     treatment of haematological malignancies. This study uses a randomised control trial design,     which is widely used in healthcare settings to test the effects of interventions and testing     cause and effect relationships between variables. A mixed methods approach for data     collection and data analysis is being used. This will facilitate measurement of patients'     psychological response to 'Open Window' using questionnaires and exploration of subjective     feelings in relation to personal experiences of having a stem cell transplant through semi     structured interviews.      Hypothesis to be tested      'Open Window' has no effect on patients' levels of anxiety, depression, or distress when     undergoing a stem cell transplant.      Results:      Of the 199 patients in the study, 96 were randomized to the intervention group and 103 to the     control group. Participants in the intervention group had significantly reduced levels of     anxiety on the day before transplant (P = 0.001), at day 7 (P = 0.041), and day 60 (P =     0.035). There was a significant reduction in depression before transplant (P= 0.022).     Participants in the intervention group reported better experiences (P < 0.005).   "
191770|NCT00348972|"     To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes     (IFG or IGT).   "
191771|NCT00348985|"     This phase I trial is studying the side effects and best dose of PXD101 and bortezomib in     treating patients with advanced solid tumors or lymphomas. PXD101 and bortezomib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. PXD101 may     also cause cancer cells to look more like normal cells, and to grow and spread more slowly.     Giving PXD101 together with bortezomib may kill more cancer cells.   "
191772|NCT00348998|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Androgens can cause the growth of     prostate cancer cells. Drugs, such as goserelin and bicalutamide, may stop the adrenal glands     from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.     Bevacizumab may also make tumor cells more sensitive to radiation therapy. Giving bevacizumab     together with hormone therapy and radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with hormone     therapy and radiation therapy works in treating patients with high-risk locally advanced     prostate cancer.   "
191773|NCT00349011|"     The purpose of this study is to determine the effects of a personalized menopausal therapy     risk assessment and genetic counseling intervention on knowledge, risk perception, and     decision-making in healthy women at increased risk for breast cancer.   "
191774|NCT00349024|"     RATIONALE: Polyvinylpyrrolidone-sodium hyaluronate gel may lessen the pain of oral mucositis,     or mouth sores, in patients undergoing treatment for cancer.      PURPOSE: This clinical trial is studying how well polyvinylpyrrolidone-sodium hyaluronate gel     works in reducing pain from oral mucositis in young patients with cancer.   "
191775|NCT00349037|"     The purpose of this study is to evaluate how effective the vaccine is at preventing subjects     developing flu symptoms after they are directly exposed to flu virus. The study will also     evaluate how well the vaccine is tolerated at sites where administrations are given, any     effects it may have on subjects' wellbeing and whether it can produce antibody responses in     the body   "
191776|NCT00349050|"     The purpose of this study is to investigate the effects of transcranial magnetic stimulation     on pain perception.   "
191777|NCT00354692|"     This pilot study will compare the effects of sodium ferric gluconate complex and iron sucrose     on urine concentrations of various chemicals including protein   "
191778|NCT00354705|"     The goal of this research study is to identify biologic and lifestyle factors that may     increase a person's risk of developing a recurrence (return) of colon cancer.   "
191779|NCT00354731|"     We aim to investigate (1) the effects of combined pentoxifylline and corticosteroids,     compared to that of corticosteroids, on patients with primary nephrotic syndrome; and if     possible (2) the effects of pentoxifylline monotherapy on patients with primary nephrotic     syndrome not suitable for or intolerant of standard corticosteroid therapy.   "
191853|NCT00357773|"     To demonstrate the efficacy of T1225 1.5% eye drops, in comparison to reference product, for     the treatment of purulent bacterial conjunctivitis, and to assess the safety   "
191781|NCT00354757|"     Background/Aim: To evaluate the optimal dosage of rabeprazole for proton-pump inhibitor (PPI)     testing of gastroesophageal reflux disease (GERD) and to test the influence of cytochrome P     (CYP) 2C19 polymorphism in a population with a high prevalence of people who poorly     metabolize PPIs.      Patients and Methods: In this randomized, open-label trial, patients with symptoms suggestive     of GERD were randomized to receive a two-week test with 20-mg or 40-mg rabeprazole after     diagnostic endoscopy. Symptom response was assessed with a four-grade daily record; in     addition, DNA from peripheral blood leukocytes was genotyped for CYP2C19 polymorphism with     polymerase chain reaction-restrict fragment length polymorphism (PCR-RFLP) technique.   "
191782|NCT00354770|"     This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of     trichotillomania   "
191783|NCT00354783|"     The purposes of this one-year follow-up study are twofold: (1) to prospectively examine the     spontaneous kicking and the supported stepping movement in VLBW premature infants until     attainment of independent walking; and (2) to assess factors (i.e. gross motor development,     cardiopulmonary function, anthropometry, body composition and cognition) that could     potentially influence walking attainment in VLBW premature infants.   "
191784|NCT00354796|"     We hypothesize that reduced dose of enoxaparin in elderly patients will result in reduced     proportion of patients with therapeutic anti Xa activity and reduced clinical efficacy.   "
191785|NCT00354809|"     This study is designed to determine whether morning doses of GW679769, taken daily for 1 to 9     days, will promote sleep during the following night without significant post-dose thinking     impairment and drowsiness in subjects with primary insomnia.   "
191812|NCT00357240|"     The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on     the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to     atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.   "
191786|NCT00354822|"     Pilot multicentre, open label study with the aim to evaluate antitumor activity in term of     the sum of complete and partial response (O.R.R.) of chemotherapy (cyclophosphamide and     fludarabine) and rituximab, followed by zevalin radioimmunotherapy and response duration     (Time to relapse or progression)and to evaluate the safety of the treatment as acute and late     toxicity.      Secondary objective is to evaluate the overall survival (OS) and the event-free survival     (EFS).   "
191787|NCT00354835|"     This randomized phase III trial is studying two different combination chemotherapy regimens     to compare how well they work when given together with radiation therapy in treating patients     with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine     sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination     chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known     which combination chemotherapy regimen is more effective when given together with radiation     therapy in treating patients with rhabdomyosarcoma.   "
191788|NCT00354861|"     This is a single centre, three single administrations (Days 1, 29 and 57) at increasing doses     of IMP321 (3, 10, 30 and 100 µg) in four cohorts of 12 subjects, single blind, randomized     study.   "
191789|NCT00354874|"     This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and     pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre,     double-blind, placebo controlled, dose ascending, four way cross-over study in approximately     28 mild to moderate asthmatic subjects.      Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will     be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical     laboratory tests, collection of adverse events (AE) information and blood samples.   "
191790|NCT00354887|"     Primary Objective:      1. To determine the objective response rate (complete plus partial) to the combination of     capecitabine (Xeloda) and oxaliplatin (Eloxatin) (XELOX) in patients with adenocarcinoma of     the small bowel and ampulla of Vater.      Secondary objectives include determining the toxicity, time-to-treatment failure, and overall     survival rates in patients treated with this combination.   "
191791|NCT00354900|"     There is an intimate relationship between processes which promote growth, invasion, and     metastasis of cancers, and processes which regulate blood clotting. The enzymes uPA and PAI-1     are key regulators of the remodeling of recently formed blood clots, and there is substantial     information linking greater levels of uPA and PAI-1 in breast cancers with a greater     likelihood of breast cancer recurrence and death. As uPA and PAI-1 are excellent markers for     a cancer's aggressive clinical behavior, uPA and PAI-1 may be potential targets for     anticancer therapy. Aprotinin is an inhibitor of uPA activation, and has been approved by the     FDA to reduce blood loss in patients undergoing cardiopulmonary bypass surgery. Studies in     animals and limited studies in patients have shown that Aprotinin slows the growth of tumors.     Our hypothesis is that uPA is chronically activated in malignancies, and that inhibition of     uPA by Aprotinin would slow the rate of progression of breast cancer.   "
191792|NCT00354913|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxyurea, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving imatinib mesylate together with hydroxyurea may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with     hydroxyurea works in treating patients with recurrent or progressive meningioma.   "
191793|NCT00354926|"     This study is designed to provide evidence of the safety and a preliminary understanding of     the efficacy of AME 133v.   "
191794|NCT00354939|"     Primary objective:      Difference in frequency of subjects with conventionally detected hypoglycemia by the subject     [at least one measurement smaller/equal 60mg/dl documented in the 8-point profile in the case     record form (CRF) or documentation of symptomatic hypoglycemia in the CRF through Visits 8/9]     compared to CGMS detected blood glucose values smaller/equal 60mg/dl during CGMS measurements     (at least one measurement through Visits 8/9) after eight weeks of treatment with insulin     glargine.      Secondary objective:      Secondary study objectives were to investigate the safety and efficacy of a treatment change     to insulin glargine in ICT treated subjects in terms of:        -  Percentage of blood glucose measurements(CGMS data)smaller/equal 60mg/dl [3.3 mmol/l].        -  Percentage of nocturnal blood glucose measurements(CGMS data)smaller/equal 60mg/dl[3.3          mmol/l].        -  Percentage of daytime blood glucose measurements(CGMS data)smaller/equal 60mg/dl[3.3          mmol/l].        -  Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose          smaller/equal 60mg/dl[3.3mmol/l], area under the curve (AUC greater/equal 180)and time          (t greater/equal 180) for blood glucose greater/equal 180mg/dl[10.0mmol/l].        -  Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose          smaller/equal 60mg/dl[3.3mmol/l]during the day (AUC 06.00am - 10.00pm)and during the          night(AUC 10.00pm - 06.00am).        -  Area under the curve (AUC greater/equal 180)and time(t greater/equal 180)for blood          glucose greater/equal 180mg/dl[10.0mmol/l]during the day (AUC 06.00am - 10.00pm)and          during the night(AUC 10.00pm - 06.00am).        -  Frequency of subjects with nocturnal blood glucose value smaller/equal 60mg/dl[3.3          mmol/l].        -  Frequency of subjects with asymptomatic nocturnal blood glucose smaller/equal          60mg/dl[3.3 mmol/l].        -  Frequency of subjects with symptomatic nocturnal blood glucose smaller/equal 60mg/dl          [3.3 mmol/l].        -  Frequency of subjects with daytime blood glucose smaller/equal 60mg/dl [3.3 mmol/l].        -  Frequency of subjects with asymptomatic daytime blood glucose smaller/equal 60mg/dl[3.3          mmol/l].        -  Frequency of subjects with symptomatic daytime blood glucose smaller/equal 60mg/dl[3.3          mmol/l].        -  Frequency of subjects with hyperglycemic blood glucose(greater/equal          180mg/dl,[10.0mmol/l]).        -  Frequency of subjects with symptomatic hypoglycemia(smaller/equal 60mg/dl [3.3mmol]).        -  Frequency of subjects with severe hypoglycemia(smaller/equal 36mg/dl [2.0mmol/l]).        -  Blood glucose values of 8-point profiles.        -  Mean daytime & mean nocturnal blood glucose of 8-point-profiles.        -  HbA1c.        -  Fasting blood glucose (FBG).        -  Dose of insulin.        -  Adjustment of insulin.        -  Body weight, body mass index.   "
191796|NCT00354965|"     Clinical research study to test amoxicillin and clavulanate tablet formulation for use in     Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and     no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of     this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR     in the body after it has been swallowed by children.   "
191797|NCT00354978|"     Objectives:        1. To estimate progression-free survival (PFS) at 12 months in subjects with metastatic          colorectal cancer who receive FOLFIRI [folinic acid (leucovorin or LV), 5-Fluorouracil          (5-FU), irinotecan) plus bevacizumab as first line treatment.        2. To determine the objective response rate and the duration of objective response in this          population.        3. To assess overall survival (OS) in this population.        4. To measure the effect of treatment on intratumoral blood volume and microvascular          permeability by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in          consenting patients in whom it is technically feasible.        5. To correlate plasma proteomics with response.        6. To assess the safety of this regimen.   "
191798|NCT00354991|"     The objective of the study is to estimate the percentage of patients who reach blood pressure     goal after 8 weeks of treatment with losartan/HCTZ combination.   "
191799|NCT00355004|"     RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to     treat. Computerized and mailed reminders may help increase the rate of colorectal cancer     screening in adults with an average risk for colorectal cancer.      PURPOSE: This randomized clinical trial is studying how well computerized and mailed     reminders work in increasing the rate of colorectal cancer screening in adults with an     average risk for colorectal cancer.   "
191800|NCT00355017|"     HF is associated with repeated hospitalisations and poor prognosis.The aim of this study is     to investigate whether BNP-guided care (BGC) in addition to multidisciplinary management(MM)     improves outcome compared to HNC alone or usual care (UC) for decompensated HF patients after     discharge.      Patients hospitalised with cardiac decompensation in 9 Viennese hospitals are randomised to     BGC, MM alone, or UC. MM includes 2 consultations of a heart failure (HF) specialist 10 days     and 2 months after discharge for recommending medical optimisation and care by a specialised     HF nurse including 4 home visits and telephone contact. In addition, BGC includes intensified     increase of medical treatment during repeated follow-up visits in a HF clinic in patients     with an Nt-BNP level above 2200pg/ml at discharge.   "
191801|NCT00355030|"     The present randomized trial was initially intended to study the benefits of a combined     treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for     pubertal children with idiopathic short stature. However, treatments were stopped in January     2012 at the request of the French drug agency. Therefore, a protocol amendment divided the     study in two study periods.      Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with     somatropin alone. Participants from France who participated in this Period 1 of the study     were asked to participate in a long term safety follow up defined as a Period 2 of the study.     Participants from the Netherlands were offered participation in Genetics and     Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov     Identifier: NCT01088412) for long term safety follow up independent of this study.   "
191802|NCT00355043|"     1. Bronchiolitis is a leading cause of morbidity and mortality in children. It is an acute,     infectious illness of the lower respiratory tract resulting in obstruction of the     bronchioles. The etiology is viral in the majority of the cases and RSV is the most commonly     isolated agent. The disease is more common in younger children under 2 years of age. Children     often receive unnecessary antibiotics and often require hospitalization. An episode of     bronchiolitis can be followed by recurrent wheezing episodes. RSV bronchiolitis in the first     year of life is one of the most important risk factors for the subsequent development of     asthma in both developed and developing countries. Thus, bronchiolitis is a global public     health problem. Zinc supplementation has been shown to be effective in both preventing and     treating pneumonia. However, no study has particularly examined the effect of zinc on ARI     associated with wheezing. This study aims to investigate whether zinc (20 mg/day) reduces1.     the duration of bronchiolitis in children.2. the severity of bronchiolitis in children.3. the     rate of hospitalization for bronchiolitis.3. future episodes of wheezing in children.   "
191803|NCT00357110|"     Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells,     clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole     and fulvestrant or anastrozole alone in patients with early breast cancer.   "
191804|NCT00357123|"     The purpose of this study is to determine whether rosuvastatin is effective as a coadjuvant     drug in the integral management of abdominal sepsis acknowledged by surgery.   "
191805|NCT00357136|"     Researchers at Towson University are conducting a study of computer password behaviors among     users who have difficulty using their hands and arms (e.g., individuals with carpal tunnel     syndrome, high level spinal cord injuries, etc.). Volunteers are needed to take a short 5-10     minute online survey.      The survey is completely confidential and anonymous. If you would like to participate, please     visit the URL below. Thank you.      http://pages.towson.edu/jdarcy/securitysurvey.htm   "
191806|NCT00357149|"     To evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel     plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy     alone in patients with locally advanced squamous cell carcinoma of the head and neck.   "
191807|NCT00357162|"     This phase II trial is studying how well belinostat works in treating patients with     myelodysplastic syndromes. Belinostat may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth and by blocking blood flow to the cancer.   "
191808|NCT00357188|"     The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100     mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in     Healthy Subjects   "
191809|NCT00357201|"     To evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with T1675,     a per os omega 3 and omega 6 polyunsaturated essential fatty acid dietary formulation, versus     placebo in patients with bilateral treated moderate dry eye syndrome   "
192506|NCT00366964|"     This study is being done to compare the efficacy of an FDA cleared laser device with other     similar systems in the market for the treatment of leg veins and hair removal in patients     with darker skin type.   "
191810|NCT00357214|"     There is increasing evidence that the acid-base balance of diet plays an important role in     the health of bones and muscles. An excess of acid in the body can result in calcium loss and     muscle breakdown. Potassium bicarbonate, a base supplement, can neutralize acid within the     body. The purpose of this study is to determine the effectiveness of potassium and     bicarbonate, alone and combined, at reducing bone loss and preventing muscle wasting in older     adults.   "
191811|NCT00357227|"     B8: Atrial fibrillation and the risk of neurological complications      Twenty-five thousand acute strokes are caused by atrial fibrillation every year. But even     more frequent than symptomatic strokes are silent infarctions of the brain. Silent strokes     remain undetected in most cases, but cumulate over time and progressively impair cognition.     The impact of atrial fibrillation on subacute brain infarctions is not yet known. Moreover,     it has not been elucidated so far how effective different therapeutic strategies in the     treatment of atrial fibrillation prevent cognitive impairment. Thus, this study aims at     evaluating the influence of different types of atrial fibrillation on silent strokes and the     related impairment in cognitive functions. Other risk factors and cardiovascular diseases     that are known to provoke the development of strokes will be assessed as well. So, it will be     possible to isolate the contribution of atrial fibrillation to silent strokes and related     cognitive impairment in segregation to other relevant factors. AF patients and controls will     be examined twice in two years in order to evaluate the role of atrial fibrillation and     differential therapeutic interventions with regard to the progression of silent strokes and     cognitive impairment in a within subject-design.   "
191813|NCT00357253|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may make tumor     cells more sensitive to radiation therapy. Giving capecitabine together with radiation     therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when     given together with radiation therapy in treating young patients with newly diagnosed,     nonmetastatic brain stem glioma or high-grade glioma.   "
191814|NCT00357266|"     This study will examine blood cells and other tissue samples from people with uveitis (eye     inflammation) to try to gain a better understanding of this condition. It will look at 1) the     differences in cells when uveitis is active and when it is under control; 2) the genes that     control the functions of these cells during different stages of the condition; and 3) the     proteins the cells make at these different stages.      Patients 6 years of age or older with an eye inflammation of at least 8 weeks' duration may     be eligible for this study. They must currently be enrolled in another NEI protocol for     evaluation or treatment of uveitis.      Participants will provide blood and possibly eye tissue samples as follows:      Blood samples: Blood samples will be drawn, probably from an arm vein, during periods when     the inflammation is bad and when it is quiet. No more than 60 mL (about 4 tablespoons) will     be drawn at any visit, and no more than eight samples will be collected in 1 year.      Tissue samples: For patients who require eye surgery, a sample of tissue or fluid that is     removed as a routine part of surgery may be provided to investigators in this study for     research purposes.      Samples will be collected during patients' visits scheduled as part of their other protocol.     The samples will be labeled with a special code number to preserve the patient's identity.   "
191815|NCT00357279|"     The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength     of denufosol compared to placebo in patients with mild CF lung disease.   "
191816|NCT00357292|"     To compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3     concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation   "
191817|NCT00357305|"     This phase I trial is studying the side effects and best dose of vorinostat when given     together with cytarabine and etoposide in treating patients with relapsed or refractory acute     leukemia or myelodysplastic syndromes or myeloproliferative disorders. Vorinostat may stop     the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used     in chemotherapy, such as cytarabine and etoposide, work in different ways to stop the growth     of cancer cells, either by killing the cells or by stopping them from dividing. Giving     vorinostat together with cytarabine and etoposide may kill more cancer cells.   "
191818|NCT00357318|"     This phase I trial is studying the side effects and best dose of bevacizumab and sunitinib in     treating patients with solid tumors. Monoclonal antibodies, such as bevacizumab, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them.     Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Bevacizumab and sunitinib may also stop the growth of tumor cells by blocking blood     flow to the tumor. Giving bevacizumab together with sunitinib may kill more tumor cells.   "
191819|NCT00357331|"     Skeletal buffering of chronic acid loads may contribute to a significant amount of bone loss     over time. Evidence from a few small short-term studies suggests that basic compounds, namely     potassium citrate and potassium bicarbonate may reduce bone loss and improve bone density.      The purpose of this study is to evaluate the effects of potassium citrate on bone metabolism.     We hypothesize that administration of potassium citrate to postmenopausal women with     osteopenia will reduce bone resorption and improve bone mineral density.      Postmenopausal women with osteopenia (T score between -1.0 and -2.5) and no history of     fracture will be randomized to either daily potassium citrate or placebo for one year.     Primary outcomes will be markers of bone turnover, which will be measured over 12 months.     Secondary outcomes will be bone mineral density, compliance, and adverse events.   "
191945|NCT00358969|"     This study is designed to investigate whether guanfacine (Tenex) is an effective treatment     for borderline personality disorder (BPD), an illness often characterized by unstable mood     and impulsive aggression. Guanfacine stimulates activity in the front portion of the brain, a     region associated with attention and the control of behavior. We believe that guanfacine may     improve symptoms of BPD by improving attention and aiding regulation of behavior.   "
191820|NCT00357344|"     This study will evaluate how large, intentional weight reduction affects the human brain and     possible ways to reverse the changes associated with excess body weight. Subtle changes in     some brain regions occur in people who are overweight. Such changes may involve the     regulation of eating behavior, though it is not clear whether the changes were present before     weight gain or are a consequence. Magnetic resonance imaging (MRI) will be used to study     local structures of the brain.      Patients ages 18 to 45 who are undergoing gastric bypass surgery and who are not pregnant or     breastfeeding may be eligible for this study. A study group of lean participants will serve     as controls. Patients will visit the Phoenix Indian Medical Center for about 3 days at a time     for tests. They will have a medical examination, electrocardiogram, and tests of blood and     urine. Questionnaires they will complete involve patients' moods and possible influence on     eating behaviors, as well as food preferences. A taste test, smell test, and assessment of     decision-making processes will be conducted. An oral glucose tolerance test involves a needle     placed intravenously (IV) in the arm, for drawing blood after patients drink a sugar     solution. The test takes about 3-1/2 hours, with six blood samples taken (about 2 tablespoons     total). A meal test also includes use of an IV line. After patients consume a liquid meal,     blood will be collected to analyze levels of blood sugar and hormones. For the DEXA scan,     which measures body composition, patients will lie still while low-dose X-rays are used for 5     to 10 minutes. Urine will be collected for 1 whole day, to measure cortisol, a hormone. The     MRI scan uses a strong magnetic field to obtain images of body organs and tissues. Patients     having any metal in the body that may interfere with the scanning machine should not have     this test. For the MRI procedure, patients will lie on a table that slides into the enclosed     tunnel of the scanner and be asked to lie still. Patients will be able to communicate with     the MRI staff at all times during the scan, and they may ask to be removed from the machine     at any time.   "
191821|NCT00357357|"     The purpose of this Phase II study is to evaluate the safety and tolerability of HF 0220 in     patients with Alzheimer's disease compared to placebo (inactive substance). The study will     also validate biochemical markers as appropriate clinical end-points and to assess the     suitability of chosen dose levels for future clinical studies.   "
191948|NCT00359008|"     The primary objective of this study is to assess the ability of the PHP & HPHP to detect     newly diagnosed non treated Chorodial neovascularization (CNV) lesion associate with advanced     age related Macular Degeneration (AMD) and differentiate them from Early/intermediate/GA AMD   "
191822|NCT00357370|"     The purpose of this clinical research study is to learn if BMS-512148, added to insulin and     one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can     help reduce the blood sugar levels compared to insulin and one or two anti-diabetes     medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2     diabetes. The safety of this treatment will also be studied.   "
191823|NCT00357383|"     To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one     instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day     2).      To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day     treatment period   "
191824|NCT00357396|"     RATIONALE: Giving chemotherapy drugs, such as busulfan, melphalan, and thiotepa, before a     donor stem cell transplant helps stop the growth of tumor cells and prepares the patient's     bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood     cells, and platelets. Sometimes the transplanted cells from a donor can make an immune     response against the body's normal tissues. Giving tacrolimus, sirolimus, and mycophenolate     mofetil may stop this from happening.      PURPOSE: This phase II trial is studying how well giving busulfan together with melphalan and     thiotepa followed by a donor stem cell transplant works in treating patients with high-risk     Ewing's tumors.   "
191825|NCT00357409|"     In blind individuals, the occipital cortex becomes capable of processing tactile and auditory     information, a phenomenon described as crossmodal plasticity. GABA is the major inhibitory     neurotransmitter in the brain and a possible candidate to mediate this form of human     plasticity. We intend to use magnetic resonance spectroscopy (MRS) to measure GABA and     hypothesize that GABA levels in the occipital cortex of blind humans will be lower than in     sighted controls. Such decrease could possibly mediate compensatory changes in the occipital     cortex of the blind.      Objective      Early blind subjects exhibit better tactile acuity than late blinds or sighted individuals.     The purpose of the study is the determine GABA levels in the human occipital cortex after     long-term light deprivation (blindness).      Study Population      Our experiments will make use of early blind, late blind, and sighted control subjects.      Design      Subject will be identified and will receive clinical and neurological examinations at the     NIH. MRS studies will be performed at NIH MRI Center with 3Tesla Magnet. Each subject head     will be positioned in an adjustable holder (designed for minimal motion and maximal comfort)     such that a flat coil lay just below the occipital cortex. The sequence has been described     before [33]. The individuals who perform the data analysis will be blind to the purpose of     the experiments.      Outcome measures      The concentration of GABA from the 14 ml voxel over the visual cortex will be measured.     Edited proton spectrum of GABA will be compared with the edited sub spectrum of creatine for     a concentration reference.   "
191826|NCT00357422|"     The purpose of this study is to choose the preferred treatment modality for solitary, small     hepatocellular carcinoma.   "
191827|NCT00357435|"     This study will explore the clinical and hereditary (genetic) features of corneal dystrophy     and other inherited corneal disease. Corneal dystrophy is clouding of the cornea - the     transparent part of the eye covering the iris and pupil that passes light to the back of the     eye. When the cornea becomes cloudy, interfering with the passage of light, vision may be     impaired or lost. Corneal problems may occur with vision problems alone, or with other     problems, such as changes in facial appearance or bone or joint problems. A better     understanding of these genetic conditions may help in the development of better diagnostic     tests and methods of disease management.      Patients with corneal dystrophies and related corneal disease and their family members may be     eligible for this study. Participants will be drawn from patients enrolled in other studies     of corneal dystrophy at the NEI and collaborating clinics.      Participants will undergo the following tests and procedures:        -  Medical and surgical history        -  Verification of diagnosis        -  Construction of a family tree regarding familial vision problems        -  Complete eye examination, including dilation of the pupils and photography of the          cornea, tests of color vision, field of vision, and the ability to see in the dark, and          photographs of the eye.        -  Blood sample collection to identify the genes responsible for corneal disease and          ascertain how they cause disease.   "
191828|NCT00357448|"     RATIONALE: Biological therapies, such as denileukin difitox, may stimulate the immune system     in different ways and may prevent tumor cells from growing. PURPOSE: This phase I trial is     studying the side effects and best dose of denileukin diftitox in treating patients with     advanced refractory ovarian cancer, primary peritoneal carcinoma, or epithelial fallopian     tube cancer.   "
191972|NCT00359320|"     The purpose of this trial is to determine whether a mucosa-to-mucosa technique of     pancreaticojejunostomy will improve the pancreatic fistula rate.   "
191829|NCT00357461|"     RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Vaccines made from gp100 peptides     may help the body build an effective immune response to kill tumor cells. Giving ipilimumab     together with vaccine therapy may be an effective treatment for melanoma.      PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how     well they work compared to ipilimumab alone in treating patients with previously treated     stage IV melanoma.   "
191830|NCT00357474|"     The purpose of this study is to choose the preferred treatment modality for multiple, small     hepatocellular carcinomas.   "
191840|NCT00357604|"     The purpose of this study is to administer a combined oral contraceptive (ethinyl estradiol     and norgestimate) with the HIV treatment of atazanavir and ritonavir to healthy females in     order to assess if the concentrations of the oral contraceptive change. The safety of this     treatment regimen will also be studied.   "
191863|NCT00357903|"     This study was designed to provide all adult and pediatric arthritis patients (placebo and     etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept     (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The     primary objective of this study is to examine safety parameters.   "
191864|NCT00357916|"     To determine the sensitisation potential of PEP005 Topical Gel (0.01% concentration) on     normal skin      To evaluate skin irritation   "
191831|NCT00357487|"     This project consists on the realization followed by the clinical validation of two medical     instruments dedicated to the precise sentinel lymph nodes identification and localization in     the case of breast cancer: an intra operative probe and an operative mini gamma camera. The     sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic     system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy     determination. The goal of these instruments designed by physicians and physicists is to     significantly improve the detection efficiency of the technique in order to reduce the false     negative rate and then the recurrence risk, as well as the operative morbidity.Clinical     oncologist surgeons and fundamental physics applied to medical imaging researchers are     involved in this project. The clinical validation of the medical instruments will be     organized in the Gynaecologic and Obstetric department of the Hospices Civils de Strasbourg     with a series of 25 patients in the framework of a regular french protocol of clinical     research.   "
191832|NCT00357500|"     RATIONALE: Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Thalidomide, celecoxib, and fenofibrate may stop the growth of cancer     cells by blocking blood flow to the cancer. Celecoxib also may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy     together with thalidomide, celecoxib, and fenofibrate may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving etoposide and cyclophosphamide     together with thalidomide, celecoxib, and fenofibrate works in treating young patients with     relapsed or progressive cancer.   "
191833|NCT00357513|"     This study will characterize the gene response of the body's immune and inflammatory cells to     stroke. There is a wide variation in stroke risk, stroke outcome, and response to     clot-busting therapy for stroke. This variation may be due to differences in people's     response to injury or infection, or to differences in genetic make-up between individuals.     Genes store the biological information that determines the body's response to injury or     infection. This study will analyze the activity of a large number of genes to try to learn     which genes might be related to patient outcome. This, in turn, may lead to an understanding     of which gene profiles are related to increased stroke risk and increased disability or     death.      Healthy volunteers over age 21 and stroke patients over age 21 who are admitted to the NIH     Stroke Program at Suburban Hospital in Bethesda, Md., may be eligible for this study.     Volunteers will be screened with a medical history, blood pressure and pulse measurements,     electrocardiogram, and neurological examination.      Participants will have 20 to 35 milliliters (about an ounce) of blood drawn for genetic     studies. The genetic material will be extracted from the white blood cells and analyzed for     normal and abnormal gene activity related to stroke.   "
191834|NCT00357526|"     The purpose of this study is to determine whether teens and young women would prefer the     Nuvaring to oral contraceptive pills after having tried both methods.   "
191835|NCT00357539|"     To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5%     - 1.0% - 1.5%) and the vehicle of T1225.   "
191836|NCT00357552|"     Most anti-HIV regimens include a non-nucleoside reverse transcriptase inhibitor (NNRTI);     however, some individuals fail on these regimens. The purpose of this study is to evaluate     the safety and effectiveness of the protease inhibitor (PI) lopinavir/ritonavir (LPV/r) in     HIV infected individuals who are failing an anti-HIV regimen that includes an NNRTI.   "
191837|NCT00357565|"     RATIONALE: Giving chemotherapy, such as busulfan, fludarabine, and melphalan, before a donor     umbilical cord blood stem cell transplant helps stop the growth of abnormal or cancer cells     and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a     donor are infused into the patient they may help the patient's bone marrow make stem cells,     red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a     donor can make an immune response against the body's normal cells. Giving cyclosporine and     mycophenolate mofetil may stop this from happening.      PURPOSE: This phase II trial is studying how well combination chemotherapy followed by a     donor umbilical cord blood transplant works in treating infants with high-risk acute leukemia     or myelodysplastic syndromes.   "
191838|NCT00357578|"     This study will examine skin and blood cells for genetic changes related to the development     of age-related macular degeneration, an eye disease that can significantly impair the ability     to read, drive, and carry out daily activities. It is the most common cause of vision loss in     people over the age of 50.      People with age-related macular degeneration and healthy normal volunteers age 50 years or     older may be eligible for this study. Candidates will undergo a medical history, physical     examination and eye examination with dilation of the pupils. Photographs of the eye will be     taken with a special camera.      Study participants will have blood drawn three times (no more than 6 tablespoons each time)     and will undergo three skin biopsies. For the skin biopsy, an anesthetic is injected under     the skin and a small piece of skin-approximately 1/4-inch cube-is removed. The blood draws     and biopsies will be done at 7- to 10-day intervals. In most cases, a single biopsy is done     at each visit, but it may be necessary to take-at most-one additional biopsy from the other     arm during the same visit. Patients will return for one follow-up visit 7 to 10 days after     the last biopsy for examination of the biopsy site and removal of any stitches.      The results of this study may provide investigators information needed to develop new means     of diagnosing and treating age-related macular degeneration.   "
191980|NCT00359424|"     The purpose of this study is to compare two different treatment approaches to recanalization     started within 3 hours of symptom onset—combined intravenous (IV) and endovascular therapy     and standard intravenous (IV) rt-PA alone.   "
191839|NCT00357591|"     The Company's proprietary products are based on Orqis Medical's hypothesis, supported by     early clinical data, that increasing and maintaining continuous blood flow in the descending     aorta, known as continuous aortic flow augmentation or CAFA, improves hemodynamics in heart     failure patients. The clinical impact of the hemodynamic improvement is currently being     evaluated to determine the effects of CAFA on stopping or reversing the progression of heart     failure through three physiological effects:        -  VASCULAR - Reducing systemic vascular resistance        -  RENAL - Improving renal function        -  CARDIAC - Reducing cardiac workload   "
191841|NCT00357617|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving celecoxib before     surgery may reduce the amount of normal tissue that needs to be removed. Collecting and     storing samples of tumor tissue, blood, and urine from patients with head and neck cancer to     study in the laboratory may help doctors learn more about the cancer and predict how well     patients will respond to treatment with celecoxib.      PURPOSE: This phase I/II trial is studying changes in tumor cells and how well celecoxib     works in treating patients with head and neck cancer that can be removed by surgery.   "
191842|NCT00357630|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with     metastatic cancer of unknown primary.   "
191843|NCT00357643|"     The primary aim of this study is to determine the effects of supplementation with both     calcium and vitamin D on changes in bone density of the hip in men and women age 65 and     older.   "
191844|NCT00357656|"     The purpose of this study is to compare the hemostatic efficacy and safety of continuous     infusion versus intermittent bolus infusion in the peri- and post-operative setting,     employing rAHF-PFM, a recombinant antihemophilic factor manufactured without added human or     animal proteins, in previously treated patients with severe or moderately severe hemophilia A     (baseline factor VIII level <= 2% of normal) who are undergoing unilateral major orthopedic     surgery that requires drain placement. The total study period per subject (from consent to     study completion) will vary from approximately 9 to 26 weeks and will involve clinical and     laboratory assessments.   "
191845|NCT00357669|"     The study will compare the efficacy and safety of brivaracetam with placebo in patients with     Unverricht-Lundborg disease.   "
191846|NCT00357682|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of esomeprazole and aspirin may prevent esophageal cancer in patients     with Barrett's metaplasia. It is not yet known whether esomeprazole is more effective with or     without aspirin in preventing esophageal cancer in patients with Barrett's metaplasia.      PURPOSE: This randomized phase III trial is studying esomeprazole with or without aspirin to     compare how well they work in preventing esophageal cancer in patients with Barrett's     metaplasia.   "
191847|NCT00357695|"     This study will examine the parts of the brain that use visual information to perform     movements. Patients with certain brain lesions tend to have difficulty in processing visually     presented objects. This study will look at the brain mechanisms underlying the visuo-motor     integration.      Healthy normal volunteers between 20 and 60 years of age are eligible for this study. People     who have had a severe head injury with loss of consciousness or any other mental or     neurological disorder diagnosed by a doctor may not participate. Candidates will be screened     with a medical history, a physical examination focusing on finger movements, and a     questionnaire.      Participants' brain activity will be recorded using two techniques -     magnetoencephalography(MEG) and magnetic resonance imaging (MRI) - while they watch pictures     of various objects flashed on a screen. MEG is a procedure to record magnetic field changes     produced by brain activity. During the recording, the subject sits comfortably in an armchair     in a dimly lit room and watches pictures presented on a screen. About 50 pictures are shown     per session. There are about five sessions, separated by 3-minute breaks. Functional MRI     involves taking pictures of the brain using MRI while the subject performs a task. MRI uses a     strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI     scanner is a metal cylinder surrounded by a magnetic field. The subject lies still on a table     that can slide in and out of the scanner. During the scan, he or she looks at pictures in six     test blocks of 1 minute each, with 30-second breaks between blocks.   "
191848|NCT00357708|"     This phase I trial is studying the side effects and best dose of vorinostat and decitabine in     treating patients with relapsed, refractory, or poor-prognosis hematologic cancer or other     diseases. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving vorinostat together with decitabine may kill more cancer cells   "
191849|NCT00357721|"     The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir     administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg,     given once daily.   "
191850|NCT00357734|"     The purpose of this study is to assess the long-term safety profile and the secondary     objective to estimate clinical benefit of ZD1839 (gefitinib).   "
191851|NCT00357747|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug.      PURPOSE: This phase I trial is studying the side effects and best dose of AEG35156 when given     together with docetaxel in treating patients with solid tumors.   "
191852|NCT00357760|"     This randomized phase II trial studies how well ziv-aflibercept (VEGF Trap) works in treating     patients with kidney cancer that has spread from the primary site to other places in the body     (metastatic) or is unable to be removed with surgery (unresectable). Ziv-aflibercept may stop     the growth of kidney cancer by blocking blood flow to the tumor.   "
191862|NCT00357890|"     Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years     old) will be randomized to either receive multiple daily injection (MDI) using Lantus     insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The proposed     protocol compares the changes in diabetes control between pump therapy and MDI treatment     groups. More importantly, however, the study evaluates how these modes of therapy may affect     the honeymoon period and glycemic control, specifically focusing on changes in insulin     sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin     concentration changes) and beta cell function (measured by mixed meal tolerance testing).     Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the     honeymoon phase by improving insulin sensitivity and beta cell function may have important     therapeutic implications that could influence the standard of care in pediatric diabetes.   "
191854|NCT00357786|"     This study will continue to evaluate the safety of using intravenous doses of Replagal for     two patients with Fabry disease. Fabry disease is a genetic disorder inherited as an X-linked     recessive trait. It causes a deficiency in the enzyme alpha galactosidase, which normally     breaks down a lipid, or fatty substance called ceramidetrihexoside, a building block in all     cells of the body. The deficiency in breaking down the lipid eventually causes that lipid to     accumulate and injure cells. Vascular, renal, and neurological problems are the results. It     is not known exactly how lipid accumulation brings about such problems, studies of another     lipid storage disorder.      Two patients 7 to 17 years of age who have Fabry disease and have been receiving intravenous     infusions of Replagal at a dose of 0.2 mg/kg of body weight every 2 weeks may be eligible for     this study.      Participants will undergo the following tests and procedures:        -  Physical examination.        -  Neurological examination.        -  Medical and medication history.        -  Vital signs.        -  Assessment of height and weight.        -  Blood tests to determine complete blood count and chemistries.        -  Electrocardiogram.        -  Doppler blood flow study.      Participants will go through a baseline evaluation, over a period of about 1 day. They will     receive an intravenous infusion of Replagal every other week, at the dose of 0.2 mg/kg of     body weight. Vital signs will be measured before the infusion and immediately and after and 1     hour afterward. There will be careful monitoring for allergic reactions and side effects. The     infusion time takes approximately 40 minutes.      This study will last at least 1 year, or until the sponsor doing the investigating or the     drug manufacturer decides to withdraw support of the study.   "
191855|NCT00357799|"     Hypothesis: The first attempt success rate for peripheral IV insertion for children with     difficult IV access (difficult IV access [DIVA] score ≥ 4) by nurses using the VeinViewer     guided technique is better than conventional method of IV placement.      Specific Aims:        1. To investigate if use of the VeinViewer can improve the success of peripheral IV          placement in children with difficult IV access        2. To validate the DIVA score      Design: Prospective randomized controlled trial/Convenience sample      Subjects: Children (0-18) presenting to the emergency department who require an IV as     determined by examining physician and with a DIVA score ≥ 3 during times when VeinViewer     machine is available and a VeinViewer trained participating nurse is on duty.      Variables:      Outcome Variables: First IV attempt success rate      Predictor Variables: IV technique used, other potential modifiers (age, weight, height, skin     shade, indication for IV, history of prematurity and, vein visibility/palpability after     tourniquet)      Methods: Subjects who meet inclusion criteria will be randomized to either conventional IV     technique or VeinViewer guided technique. The nurse will attempt the IV depending on the     randomization. Success or failure on first IV attempt will be recorded. If unsuccessful,     other attempts will be tried until a successful IV is placed or the physician decides to give     an alternative therapy that does not need IV access.      Statistics: A chi square test will be used to compare the proportion of subjects with     successful first attempt IV placement using the VeinViewer technique to that using the     conventional method with 95% confidence interval. We, the researchers, will look at the     median number of attempts to place an IV in each of the groups. Logistic regression will be     performed to test for independent associations. Information collected during the study will     also be used for validation of the DIVA score.      Risks: No extra risks are expected above that of receiving a standard IV. The standard risk     of bleeding, bruising, pain, and infection will be possible regardless of technique used. The     VeinViewer does not expose the patient the ionizing radiation. The use of the VeinViewer     technique may increase the time need to place an IV in.      Potential Benefits: With this study, we, the researchers, hope to improve the success rate of     children with difficult IV placement in the Emergency Department.   "
191856|NCT00357812|"     The aim of this study is to compare the safety, specificity, sensitivity and ease of     procedure of two potential diagnostic assays for HSV-1 detection in the cornea. Through the     use of this new diagnostic assay, correct and early intervention would not only reduce     corneal scarring from HSK, but it would also allow the initiation of appropriate treatment     for HSV mimicking keratitis.      HSV-1 infection of the eye can result in corneal scarring and blindness. Early diagnosis of     this condition and appropriate treatment is of utmost importance. Various ocular surface     conditions can mimic herpetic keratitis in their clinical presentation and can result in     diagnostic confusion. Inappropriate or delayed treatment of herpetic corneal disease results     in increased morbidity.      In the UK at present clinical presentation is the mainstay of diagnosis. Unfortunately these     cases often present to the most inexperienced clinical staff resulting in variability in     diagnostic acumen. This often results in a delay or inappropriate diagnosis of herpetic     keratitis. Laboratory techniques presently available to aid diagnosis are infrequently used     in clinical practice. There are various reasons for their lack of use. Historically viral     culture techniques were the mainstay of investigation but were slow, requiring weeks to     provide a result. PCR is now replacing culture techniques and is relatively quick, reliable     and sensitive. Many clinicians within the UK are still not fully informed of these advances     and are therefore not utilizing these techniques to supplement clinical diagnosis.      We propose to investigate the use of topically applied fluorescent antibody against active     replicating HSV-1 in a droplet form and real time PCR detection of the virus. If successful     this should increase the potential diagnostic capabilities of GPs and other less experienced     health care workers. Such tests should reduce variability in diagnosis and the dependency on     experienced ophthalmologists to diagnose the condition.   "
191857|NCT00357825|"     The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in     patients with fibromyalgia.   "
191858|NCT00357838|"     We hypothesized that there's difference between follicular phase and luteal phase of normal     women in radial pulse waves and tongue figures.   "
191859|NCT00357851|"     Pancreatitis is caused by an acute injury on the pancreas. This illness is associated with     abdominal pain, vomiting or even fever. We have recently reported a high rate of acute     pancreatitis developing in children who undergo posterior spinal fusion for scoliosis (to     correct spinal curve). We showed that the amount of blood loss during the surgery is related     to the incidence of pancreatitis. In addition, some markers that monitor tissue injury are     elevated after the surgery and significantly higher in the patients who develop acute     pancreatitis later. We propose that if blood loss and tissue injury could be reduced, then     the incidence of pancreatits may be less in these children. Therefore we plan to use a drug     Aprotinin to just do that. Aprotinin has been used to reduce blood loss in patients     undergoing posterior spinal surgery, the same population we propose to study. If it turns out     that Aprotinin can reduce blood loss or/and the damage to the pancreas, thus pancreatitis, it     will diminish the pain and discomfort, and shorten hospital stay in these children. The     results from this study will guide medical care in these children in the future.   "
191860|NCT00357864|"     To investigate headache score and accompanying symptoms during and after infusion of     carbachol.   "
191861|NCT00357877|"     Adult tooth decay is an infectious disease that afflicts the majority of Americans aged 55     and older and is the most common chronic disease at midlife with an ever growing economic     toll. Despite the fact that specific bacteria cause tooth decay, no FDA-approved     anti-microbial treatment for decay is available to the American dental professional. The     Prevention of Adult Caries Study (PACS) is a study designed to evaluate the efficacy of a     topical, temporary, 10% w/v chlorhexidine dental coating in reducing new decay in adult     dental patients at risk for decay.   "
191981|NCT00359437|"     Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the     recurrence of ascites.      Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over     a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites.      The one-year double blind placebo controlled period is extended up to 2 years in a long term     safety study (PASCCAL-2).   "
191865|NCT00357929|"     Some patients receiving mechanical ventilation have difficulty weaning off the ventilator     because of physiological factors such as pre-existing lung disease, respiratory distress     syndrome, and trauma among others. Allowing patients to become hypercarbic (increased blood     bicarbonate level) may make it easier for these patients to be taken off the ventilator and     resume breathing on their own.   "
191866|NCT00357942|"     Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often     associated with painful ulcers in the mouth. The study hypothesis is that morphine     administrated as a mouthwash can relieve stomatitis-related pain by a local analgesic effect.      The purpose of this study is to test the analgesic effect of a morphine mouthwash versus     morphine injections or placebo (no active drug) in children/adolescents with stomatitis     related to chemotherapy. Besides the investigational drugs (morphine mouthwash and morphine     injections) the children/adolescents receive a standardized analgesic treatment for     stomatitis-related pain.   "
191867|NCT00357955|"     The purpose of this research is to study whether a multidisciplinary education in Diabetes     and intervention for cardiac risk reduction in a group setting to modify patient behavior and     adjust medications can achieve diabetes guideline goals for glycemia, blood pressure and     lipid control.   "
191868|NCT00357968|"     The purpose of this study is to provide information of the relative potency of prasugrel and     clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects     undergoing elective percutaneous coronary intervention (PCI).   "
191869|NCT00357981|"     Dr. Eleanor Drey in the Department of Obstetrics, Gynecology and Reproductive Sciences UCSF     is conducting a study to examine the personal and economic impact of continuous use of ORTHO     EVRA, the contraceptive patch, on menstrual related symptoms for women who report having     severe menstrual related symptoms.   "
191870|NCT00357994|"     The primary objective of this study was to demonstrate the superiority of levodopa -     carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12     weeks.   "
191871|NCT00358007|"     To evaluate the use of cone beam computed tomography in treating head and neck to hopefully     reduce side effects   "
191872|NCT00358020|"     The purpose of this study is to evaluate the safety and the efficacy of the association of     Melphalan/Prednisone/Thalidomide/VELCADE (MPTV) as salvage treatment in advanced and     refractory myeloma patients. This association might further increase the response rate     achieved by the standard oral MP regimen.   "
191873|NCT00358033|"     The purpose of this study is to determine whether a combined behavioral and pharmacological     intervention provided by a multidisciplinary team will further reduce LDL-C, smoking, BP and     Hb-A1C in diabetic patients with A1c between 7% and 9% when compared to usual care.   "
191874|NCT00358046|"     This is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease     patients with hyperphosphatemia on hemodialysis. Patient participation in the study is     approximately 10 weeks in duration.   "
191875|NCT00358059|"     Effective adaptation to type 1 diabetes mellitus requires adolescents and their families to     work together effectively to solve problems and resolve disagreements in order to achieve     acceptable diabetic control and treatment adherence. Many studies show that problematic     family communication, insufficient parental involvement in care and parent-adolescent     conflict are associated with poor adherence and poor diabetic control. This study tests a     family communication and problem solving intervention by randomizing families of adolescent     with type 1 diabetes to 6 months' treatment either with the experimental intervention,     continuation in standard medical care for diabetes, or participation in a multifamily     educational support group. Families are then followed for an additional 12 months to examine     the longer-term effects of the interventions on the targeted diabetes outcomes.   "
191876|NCT00358072|"     The study aims to optimize the concept of risk-oriented postremission consolidation therapy,     by offering (i) standard consolidation-maintenance to patients at lowest risk of relapse as     defined by MRD(Minimal Residual Disease) negative status, and (ii) allogeneic stem cell     transplantation (related/unrelated donor available) or multicycle high-dose therapy with     autologous blood stem cell transplant (no donor) to patients at highest risk of relapse as     defined by MRD+ status.      The prognostic role of MRD evaluation in unselected patients will be evaluated.   "
191877|NCT00358085|"     Objectives.      To study the feasibility of an expertise-based randomized controlled trial (RCT) testing the     role of traditional surgery (OPEN) versus endovascular repair (EVAR) for abdominal aortic     aneurysms (AAA).      Study design.      We will conduct an expertise-based RCT comparing OPEN to EVAR of non-urgent abdominal aortic     aneurysms in patients referred to vascular surgeons practicing at Hamilton Health Sciences,     to determine the rate of death and other complications. Quality of life and status at 6     months will also be recorded. The ultimate goal is to determine the feasibility of conducting     a pragmatic expertise-based RCT and to inform a future larger study at a national level.   "
191878|NCT00358098|"     This study of hormone positive (estrogen receptor [ER]), metastatic invasive ductal breast     cancer looks at functional scanning using positron emission tomography (PET) and patient     response to hormone therapy. Functional scans allow investigators to see more than one     metastatic location. The investigators will use an estrogen based agent (FES) to see the     number of hormone positive metastases and compare that to positive lesions on routine glucose     (FDG) based scanning.      FES and FDG-PET results will be compared to give a FDG to FES ratio. The PET ratio will be     calculated before hormone therapy and at relapse after treatment. The investigators will     biopsy an accessible lesion that is FDG positive and FES negative and perform pathological     testing for ER and PR positivity and compare it to the original primary tumor ER/PR. The     investigators will test the lesion for tumor proliferation (using Ki-67) and aggressiveness     using human epidermal growth factor receptor 2 (HER-2). Results will be compared to the     primary tumor Ki-67 and HER-2 to determine concordance.      The investigators will have pre-treatment results for FES and FDG-PET, will calculate the     ratio, and will correlate it to the primary metastatic lesion and test for ER/PR, Ki-67, and     HER-2, and subsequent response to therapy. The investigators will determine the FES-PET     predictive value for determining appropriateness of hormone therapy for metastatic disease.     With these results, the investigators plan to undertake future tumor biomarker/PET studies in     metastatic breast cancer.   "
191882|NCT00358150|"     Gaucher disease is a genetic disease that results in a deficiency of an enzyme acid     beta-glucosidase, also known as glucocerebrosidase. This enzyme is needed to digest a     substrate (lipid) called glucosylceramide and, to a lesser degree, glucosylsphingosine. In     participants with Gaucher disease, the liver, spleen, bone marrow and brain show increases in     lipid concentration, specifically in cells derived from the monocyte/macrophage system.      Eliglustat tartrate (Genz-112638) is an oral drug that may regulate the Gaucher disease     process by decreasing the synthesis of glucosylceramide. The primary objective of this study     is to evaluate the efficacy, safety and pharmacokinetics (PK) of eliglustat tartrate,     administered as an oral dose of either 50 milligram (mg) twice daily (BID) or 100 mg BID, to     men and women with Gaucher disease Type 1 for 52 weeks.   "
191883|NCT00358163|"     PTK787/ZK 222584 is an inhibitor of VEGFR family tyrosine kinases. The primary objective of     this study is to assess the safety of daily oral PTK787/ZK 222584 in combination with     paclitaxel infused every 21 days. Secondary objectives include pharmacokinetic assessment of     the impact of PTK787/ZK 222584 on paclitaxel metabolism and evaluation of tumor response to     the investigational treatment.   "
191884|NCT00358176|"     To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per     month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar     spine in postmenopausal women with osteoporosis.      To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in     postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral     neck and femoral trochanter and decreasing bone resorption.      To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month     as compared to 5 mg risedronate taken daily.   "
191885|NCT00358189|"     The purpose of this study is to assess the effects of unilateral deep brain stimulation on     upper and lower extremity motor function in advanced Parkinson's disease patients. It is     hypothesized the unilateral stimulation will lead to improvements in bilateral motor     functioning.   "
191886|NCT00358202|"     Randomized trial of nursing home residents with pneumonia to assess if intramuscular cefepime     is a safe, efficacious, and cost-effective alternative to once daily intramuscular     ceftriaxone for the treatment of elderly nursing home residents who develop pneumonia and do     not require hospitalization.   "
191887|NCT00358215|"     The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin     alfa compared to placebo on the composite of time to death from any cause or first hospital     admission for worsening heart failure in patients with symptomatic left ventricular systolic     dysfunction and anemia.   "
191888|NCT00358228|"     The primary study objective was to assess the efficacy of 2 fixed doses of rimonabant versus     placebo on abstinence from tobacco use in cigarette smokers.      The secondary study objectives were:        -  To evaluate the effects of rimonabant on craving and weight;        -  To evaluate the clinical and biological safety and tolerability of rimonabant in a          population of cigarette tobacco smokers during a 10-week treatment period        -  To evaluate the population pharmacokinetics of rimonabant (ie, standard PK evaluation in          the population of smokers);        -  To observe the percentage of abstinent patients during a 40-week follow-up post          treatment period;        -  To evaluate quality of life (QOL) and pharmacoeconomics.   "
191889|NCT00358241|"     Early physical therapy after knee surgery is very painful on top of pain from surgery. Pain     following surgery can limit recovery. One way to treat pain is by giving intravenous (IV)     pain medication with morphine. Another method is to use a “nerve block” which involves     placing a thin catheter (tube) into the lower back near the nerves that sense pain in the     knee and give a local anesthetic to numb the nerves. Sometimes both methods are used     together. This research is being done to determine whether nerve blocks with a local     anesthetic improve knee recovery in addition to providing pain relief as compared to IV pain     medicine alone   "
191890|NCT00358254|"     The objective of this study is to assess the performance of a noninvasive device for the     early screening of Diabetes Mellitus.   "
191995|NCT00351962|"     Medically inoperable lung cancer or metastatic lung tumours will be treated with fractionated     stereotactic radiation using a schedule of 1) 12 Gy x 4 treatments or 2) 6 Gy x 10     treatments.   "
198716|NCT00449722|"     To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing     of total 3.0 g mesalazine granules in patients with active ulcerative colitis   "
191891|NCT00358267|"     Turbinates are large structures in the nasal airway that help the nose to clean and humidify     the air we breathe. Inferior turbinates can swell up and block the breathing passage, making     it hard to breath. To address this, turbinate size must be reduced.      This study looks at two common procedures for turbinate reduction:        1. Radiofrequency Ablation (RFA) involves inserting a special needle into the inferior          (lower) turbinate that releases thermal energy, which significantly reduces its size.          This can be done under local anesthesia at the doctor's office.        2. Partial Resection of Inferior Turbinate (PRIT) involves surgically removing a piece off          the turbinate, which also reduces its size.      While both procedures improve nasal obstruction, no study has directly compared which is more     effective.      Eighty patients being treated for septal deformity and turbinate hypertrophy will be randomly     chosen for either PRIT or RFA treatment. They will fill out a simple, five question survey     that measures how they view their nasal blockage 4 times in one year. We believe that since     PRIT permanently removes a part of the turbinate, PRIT patients will report more improvement     than RFA patients one year later. We believe that complications (measured by the doctor) will     be the same for both treatments.   "
191892|NCT00358280|"     The purpose of this study is to compare the efficacy, duration of motor block until return to     normal function in the non-operated leg after the start of injection, of ropivacaine 5 mg/ml     and bupivacaine 5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral     lower limb surgery.   "
191949|NCT00359021|"     The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200     mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator     selected optimized background in HIV-1 infected patients who have participated in a DUET     trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week     24 or later in these trials.   "
191893|NCT00358293|"     Nightly administration of 8 mg of a unique sublingual (under the tongue) formulation of     tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve     next-day spasticity, about 12 hours following dosing in 20 multiple sclerosis (MS) patients.     This improvement was statistically significant when compared to oral tizanidine dosing. The     current study is being undertaken to see if increasing the dose to 12 mg once nightly will     result in an even greater improvement, with a longer effect, i.e., next day improvement in     spasticity both in the morning as well as in the late afternoon.   "
191894|NCT00358306|"     To understand how AKI (Acute Kidney Injury) leads to chronic kidney disease so therapies can     be found to alter the progression of events thereby significantly impacting the long-term     outcomes of children who develop AKI.   "
191895|NCT00358319|"     This is a Phase I study looking at the combination of Valproic Acid (VPA) and Karenitecin to     treat patients with metastatic malignant melanoma. We will find the dose-limiting toxicity     (DLT) and the highest dose (maximum tolerated dose) of this combination treatment that has     acceptable side effects and recommend a Phase II dose level.      There will be seven escalating doses of Valproic acid and one dose escalation step of     Karenitecin. Each patient shall receive one cycle of Karenitecin alone (cycle 1 days 1 - 5)     followed by the same dose of Karenitecin given in combination with VPA (cycle 2 days 1-7).     Patients will receive oral VPA in divided doses for 5 days and Karenitecin starting on the     3rd day every 3 weeks (a treatment cycle).      Treatment will continue until progression of disease or an unacceptable level of toxicity.     After 2 cycles of treatment there will be the first efficacy evaluation or restaging of the     disease. In the absence of disease progression and if there is continued safety and     tolerability, treatment may continue.   "
191896|NCT00358332|"     The purpose of this study is to test the safety and dosages of a malaria vaccine in 100     children, 1-6 years old, in Bandiagara, Mali. The study is testing the safety of the vaccine     when it is given to people who are regularly exposed to malaria and it will provide     information regarding optimal vaccine dosage. This study will compare 3 injections of     different vaccine doses to a rabies vaccine that is already approved. During the study, the     child's health will be checked in the clinic and during home visits. Children may participate     for about 14 months, and blood will be taken from each child throughout the study. If the     child becomes sick from malaria, he/she will be treated. Information from this study may be     used to develop a malaria vaccine that will help control the disease.   "
191897|NCT00358345|"     The primary objective of this study is to assess the ability of the PreView PHP(study     device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion     associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate     them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no     CNV.      This study secondary is to enhance NotalVision normative database.   "
191898|NCT00358358|"     This study will last for approximately 14 weeks and will involve 5 visits. The study is being     carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD     is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can     include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient.     The effects of drug treatment are usually measured by conducting lung function tests     (breathing tests) using a machine called a spirometer but this does not always provide a     complete picture of how well your COPD is responding. In this study we therefore want to look     at new and more sensitive ways of measuring COPD. The results of this research will help in     the assessment of new drugs for COPD in the future.   "
191899|NCT00358371|"     Primary objective:To study the absolute bioavailability, distribution and elimination     parameters of flucloxacillin from two oral formulations of flucloxacillin in healthy male     and/or female subjects.   "
191900|NCT00358384|"     This study is an exploratory study to evaluate the effectiveness, safety and tolerability of     three concentrations of GW786034 ointment following treatment to small areas of stable     psoriatic plaques. Dosing will proceed using a microplaque approach, where small volumes of     ointment will be applied under full occlusion to representative psoriatic plaques. The     effectiveness of topical GW786034 treatments and controls will be explored using visual     intensity assessments in addition to dermal imaging and histological surrogates of disease     activity.   "
191901|NCT00358397|"     This study will include a one time intravenous (IV) infusion of Clostridium novyi-NT (C.     novyi-NT) spores to treat solid tumors which have not responded to standard therapy.   "
191902|NCT00358410|"     This study was designed is to examine the idea that GW679769 has an effect on three of the     pathophysiological disturbances reported in patients with Functional Dyspepsia (FD): impaired     stomach accommodation to a meal, delayed stomach emptying, and visceral hypersensitivity to     distension.   "
199763|NCT00461305|"     The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic     bleeding profile in patients with dysmenorrhea and to investigate the long term safety   "
191903|NCT00358423|"     This research is being done to look at the effects of an experimental drug called pegaptanib     (also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue     in the back of the eye) that can occur after cataract surgery. Swelling in the retina can     lead to blurry vision.      The only treatment available for this condition is eye drops that decrease swelling in the     back of the eye, but eye drops may not decrease the swelling in everyone. We want to see if     pegaptanib can decrease swelling in the retina and improve vision in patients with swelling     after cataract surgery.   "
191904|NCT00358436|"     To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with     moderate to severe COPD during one year of treatment.   "
191905|NCT00358449|"     This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of     intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.   "
191984|NCT00359476|"     The purpose of this study is to learn if vinflunine can shrink or slow the growth of cancer     in patients with advanced or metastatic stomach cancer who have progressed on a prior     treatment with a fluoropyrimidine or taxane-containing chemotherapy regimen. The safety of     this treatment will also be studied.   "
191985|NCT00359489|"     Methods study to evaluate use of cardiac ultrasound to assess heart valve abnormality in     people.   "
191906|NCT00358462|"     The purpose of this study is to find out which of 2 different antibiotics, doxycycline or     azithromycin, works best against germs that may cause nongonococcal urethritis.      Study participants will include approximately 1200 men, 16 years of age or older, attending a     sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral     inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a     visible urethral discharge upon examination).      Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each     participant will receive a blinded packet of study medication. Participants will answer an     enrollment questionnaire and will also receive a log to complete between visits to record     information about treatment adherence, side effects, symptoms, and sexual activity. All     subjects will be asked to return for evaluation 3 weeks after the initial clinic visit.     Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit     will also be asked to return for a third study visit, 6 weeks following the initial clinic     visit. During follow-up visits, participants will answer a follow-up questionnaire and will     be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium     and/or Ureaplasmas will be re-tested for these organisms.      Study participants with signs and/or symptoms of urethritis or who test positive for M.     genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment     packet containing the alternate medication. Those who require additional treatment at the     6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study     participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic     visit, but who continue to demonstrate signs and/or symptoms of infection at their single     follow-up study visit will treated according to clinic standard of care (after the study     clinician unblinds their randomly-assigned treatment regimen).   "
191907|NCT00358475|"     This study was designed to assess safety of an investigational nasal spray in the treatment     of perennial allergic rhinitis. Perennial allergic rhinitis is triggered by house dust, mite     and mold etc. Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.   "
191908|NCT00358488|"     This study is designed to determine the efficacy and safety of a new long-acting beta-agonist     for asthma patients (GSK159797) following dosing for 14 days.   "
191909|NCT00358501|"     The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25     mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2)     evaluate serum and endothelial markers of veno-occlusive disease (VOD) through the analysis     of blood samples.   "
191910|NCT00358514|"     This study has been designed to allow us to learn more about diagnosing Compartment Syndrome,     which is a condition that occurs in approximately 5% of tibial (lower leg) fractures. In     Compartment Syndrome, nerves, muscle and blood vessels are affected by swelling within the     enclosed spaces (compartments) of the leg. The tissue covering these compartments (called the     fascia) is not expandable and is not able to accommodate this swelling, and so the tissues     within the compartments become compressed. If the pressure is not relieved it can result in     blood flow being blocked to the inside of the compartment (muscle, blood vessels, and nerves)     which can lead to permanent injury to the muscle and nerves. Late complications in untreated     compartment syndrome include a failure of the injured bone to heal, nerve damage, and     contracture (shortening) of muscle, all of which can result in a weak, painful, stiff, and     poorly formed limb that is not functioning well, and could result in amputation.   "
191911|NCT00358527|"     This study will hope to show that by relieving the participant's nasal symptoms of seasonal     allergies using mometasone furoate nasal spray, the participant will obtain a better quality     of night-time sleep, which in turn, causes less daytime sleepiness so that he/she can     function productively during the day.   "
191912|NCT00358540|"     The study will evaluate the safety and tolerability, optimal biologic dose, and     pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet     count and are receiving ADRIAMYCIN and ifosfamide (AI) chemotherapy.   "
191913|NCT00358553|"     The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, and safety of     recombinant human insulin. The study will consist of 2 phases.   "
191914|NCT00358566|"     To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally     advanced and metastatic adenocarcinoma of the pancreas.   "
191915|NCT00358579|"     The effectiveness of medications in cardiac arrest has been greatly debated and questioned.     Historically intravenous adrenaline has been the drug of choice since 1906. There have been     few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical     trials have not been able to show any benefit with intravenous adrenaline (compared to     placebo or no treatment) in the field.      Thus the purpose of this study is to compare vasopressin and adrenaline in the treatment of     cardiac arrest to answer the question whether there is an improvement in survival between     vasopressin and adrenaline.   "
191916|NCT00358592|"     This is a randomized controlled trial comparing the use of the Mobius™ retractor to the use     of traditional metal retraction instruments in non-urgent cesarean deliveries of obese women.     The Mobius™ retractor was designed for abdominal surgery to improve visualization of the     surgical field through standard surgical incisions and is now a standard instrument used for     cesarean deliveries at Thomas Jefferson University Hospital. We hypothesize that the use of     the Mobius™ retractor during cesarean deliveries in obese women decreases operative time,     blood loss, number of transfusions, infectious morbidity, incision length, and intra- /     post-operative antiemetic and pain medication use, while increasing surgeon satisfaction.   "
191917|NCT00358605|"     This study will look at whether patients with OSAHS already successfully treated with nasal     CPAP could successfully use an oral appliance as a short-term treatment alternative and     whether patients who could use an oral appliance as an alternative would actually avail of     its use, and to assess their preference in terms of treatment modality. The combination of     therapies if tolerated, will allow greater flexibility of treatment and opportunity for     ongoing compliance in circumstances where CPAP cannot be used.   "
193197|NCT00374647|"     Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous     calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained     long-term on MMF and sirolimus.   "
191946|NCT00358982|"     MGCD0103 is an experimental drug that belongs to a class of drugs known as the histone     deacetylase inhibitors, which may restore normal control in cancer cells by affecting the     genes and proteins that are being made. Laboratory tests show that this new investigational     anti-cancer drug can slow down the growth of human cancer cells in mice; two clinical     research studies are currently being performed in humans with cancer and a similar study is     being performed in patients with the same disease.      The purpose of this study is to find out what effect the experimental drug MGCD0103 has on     patients with relapsed and refractory Hodgkin's lymphoma.   "
191947|NCT00358995|"     A New Cognitive Behavioral Therapy to Target Distorted Appraisals Characteristic of Primary     Obsessions in Obsessive Compulsive Disorder   "
191918|NCT00358618|"     We are investigating a new technique for testing the effect of drugs on electrical activity     in the heart. Disturbances of this electrical activity can cause life-threatening changes to     heart rhythms. A better way of measuring the risk has recently been developed, and our     research team leads the world in using this tool to test the safety of drugs used in     children. Children and their families want to know that the drugs being used are safe, as do     the doctors that care for them. In this study, we will take heartbeat tracings (ECGs) from 60     children before and during their operations. The ECGs will then be checked by a children's     heart specialist. Differences on the ECGs will be related to the presence and amount of drug     (propofol) given. We expect that the propofol will not cause any changes that show increased     risk of abnormal heart rhythms. We can then tell patients, parents and regulatory authorities     of the safety profile of this aspect of the drug; moreover, the study can be used as a model     for testing many other drugs used in hospitals.   "
191919|NCT00358631|"     The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and     100 mg twice daily) compared to placebo and escitalopram 10 mg once daily in outpatients with     major depressive disorder.   "
191920|NCT00358644|"     The purpose of this study is to estimate the rate of complete remission, as well as overall     survival, in older patients with Acute Myeloid Leukemia (AML).   "
191921|NCT00358657|"     This phase I/II trial studies the side effects of fludarabine phosphate, cyclophosphamide and     total-body irradiation followed by donor bone marrow transplant and cyclophosphamide,     mycophenolate mofetil, tacrolimus, and sirolimus in treating patients with primary     immunodeficiency disorders or noncancerous inherited disorders. Giving low doses of     chemotherapy and total-body irradiation before a bone marrow transplant helps prepare the     patient's body to accept the incoming donor's bone marrow and decrease the risk that the     patient's immune system will reject the donor's stem cells. When the healthy stem cells from     a donor are infused into the patient they may help the patient's bone marrow make stem cells,     red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a     donor can make an immune response against the body's normal cells called graft versus host     disease. Giving cyclophosphamide, mycophenolate mofetil, tacrolimus, and sirolimus after the     transplant may help decrease this from happening.   "
191922|NCT00358670|"     This is a long-term, randomized, multi-center, open-label study of infliximab treatment in     adults with moderate to severe plaque-type psoriasis. This study is the long-term extension     of Study P04271 (NCT00251641); Study P04271 is a Phase 3b, randomized, parallel-group,     multicenter, open-label, 26-week study comparing the efficacy and safety of infliximab versus     methotrexate in the treatment of adult subjects with moderate to severe plaque-type     psoriasis. The objectives of this study are to assess the efficacy and safety of long-term     maintenance therapy versus intermittent therapy with 5 mg/kg infliximab in a moderate to     severe plaque-type psoriasis population.      During an interim safety evaluation of the trial, a higher incidence of serious and severe     infusion reactions was observed in the intermittent treatment arm, consisting of a     re-induction cycle (maximum of 4 infusions at 0, 2, 6 and 14 weeks) after a period of no     treatment compared with the maintenance arm (infusions every 8 weeks without an interruption     of treatment). Consequently, the sponsor has terminated the trial. The label will be updated     to reflect this new information relating to the use of a re-induction regimen with     infliximab.   "
191923|NCT00358683|"     The primary aim of this study is allow the patients suffering from Crohn's disease , who both     completed the therapeutic confirmatory study C87055 of certolizumab pegol and benefited from     the treatment, to receive treatment with certolizumab pegol until the drug is available for     the Crohn's disease indication in Greece.   "
191924|NCT00358696|"     The primary purpose of this study is to evaluate the impact of changing didanosine in an     effective anti-HIV regimen to tenofovir on virologic suppression. We hypothesize that, in     patients with maximal virologic suppression on a double class regimen (including two NRTIs     and an NNRTI or a PI, boosted with RTV or not), a single drug substitution of didanosine for     tenofovir will represent a viable strategy without any negative impact on the virologic     efficacy of the regimen.   "
191925|NCT00358709|"     To verify the efficacy of a group cognitive-behavioral therapy approach to lessening     psychotic symptoms of individuals with a first episode of psychosis, and to compare its     effects to a known skills training approach and a control group. Our primary hypotheses were     that CBT would do better than the control group at all points in time, and better than the     skills training approach, though only at follow-ups   "
191926|NCT00358722|"     Fermagate is a phosphate binder that absorbs phosphate from food, reducing the amount that     the body can absorb.      The purpose of this study it to look at the safety of fermagate over longer periods of time.   "
191927|NCT00358735|"     Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin     (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA     surgery in comparison with LMWH.   "
191928|NCT00358748|"     The purpose of this study is to investigate the early use of hydrocortisone in hypotensive     very low birth weight infants.      Based on the observations that:        -  hypotension is a common problem in very low birthweight infants and is associated with          brain injury and poor neurological outcomes;        -  some infants are refractory to standard treatment (volume expansion and vasopressors),          which is not exempt of adverse effects;        -  relative adrenal insufficiency has been described in this population; we hypothesize          that hydrocortisone is effective in the treatment of hypotension in this population and          reduce the need for vasopressors.   "
191943|NCT00358943|"     The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational     program that tracks the routine clinical outcomes for patients with Gaucher disease,     irrespective of treatment status. No experimental intervention is involved; patients in the     Registry undergo clinical assessments and receive care as determined by the patient's     treating physician.      The objectives of the Registry are:        -  To enhance the understanding of the variability, progression, and natural history of          Gaucher disease with the ultimate goal of better guiding and assessing therapeutic          interventions;        -  To provide the Gaucher medical community with recommendations for monitoring patients          and to provide reports on patient outcomes to help optimize patient care; and        -  To evaluate the long-term effectiveness of Cerezyme.   "
191929|NCT00358761|"     This study will evaluate blood and tissue samples for a condition called Southern     Tick-Associated Rash Illness (STARI). This is a skin rash resembling erythema migrans, the     rash found in people infected with Lyme disease. In the south and southeastern United States,     STARI is associated with the bite of the lone star tick. Researchers seek a better     understanding of the cause of STARI. Through researchers' knowledge, diagnostic tests could     be developed. NIH is conducting this study along with the Centers for Disease Control and     Prevention (CDC).      Patients ages 14 years and older who have recently been diagnosed with possible STARI, who     have not taken antibiotics for it longer than 1 day, and whose skin does not form large scars     may be eligible for this study. About 20 participants will be enrolled over a 5-year period.     Patients will visit the NIH Clinical Center for two or three visits. The first visit may last     2 hours. Photographs will be taken of the rash, and a blood sample of about 1-1/2 tablespoons     will be collected for tests. Patients will undergo a punch biopsy of three small pieces of     skin, from the rash. The area of the skin will be cleaned, and patients will receive a local     anesthetic at the biopsy site. A sharp instrument will remove a round plug of skin, about the     size of half a pencil eraser. Patients may feel a pushing sensation, but there should not be     pain. The site usually heals without sutures, though the doctors may close it with special     adhesive bandages or one or two sutures. Patients will receive instructions about how to take     care of the biopsy site. If sutures are used, patients will return in 7 to 10 days to have     them removed-or a patient's own doctor may remove the sutures. Patients will return to NIH at     4 to 6 weeks following their first visit. At that time, they will answer questions about how     they are doing and donate about 2 tablespoons of blood. Blood and skin samples will be used     for research at NIH and CDC.   "
191930|NCT00358774|"     Common colds affect many people and are the cause of bothersome symptoms such as runny or     stuffy nose, sore throat, headache and sneezing. Common colds can also cause more severe     illnesses in certain groups of people like the elderly, people with chronic lung diseases     such as asthma.      This study is designed to test whether a non-drug (homeopathic) nasal spray will reduce the     incidence of colds, decrease cold related symptoms or shorten the length of the cold.   "
191931|NCT00358787|"     Completely displaced (Type III) supracondylar fractures of the humerus are treated in the     operating room and are held together with pins stuck into the bone. There are two ways of     inserting the pins: crossed and laterally. The crossed method is often used because it is     thought to be more stable, but this method also carries a risk of hitting the ulnar nerve. It     is not known which method is more stable. Our hypothesis is that loss of reduction will be     equivalent between the two pinning methods.   "
191932|NCT00358800|"     This study will evaluate the use of REMStar Auto with C-Flex (RSA C-Flex) therapy in subjects     with previously diagnosed obstructive sleep apnea / hypopnea syndrome, during in-laboratory     studies. The study will determine the ability of RSA C-Flex therapy to effectively treat the     sleep apnea events. Mask leak and key sleep parameters will be monitored, and are expected to     be improved with C-Flex vs. CPAP therapy. Satisfaction from both patient and technician will     also be monitored.   "
191933|NCT00358813|"     The purpose of the study is to evaluate how subjects with mild or moderate kidney problems     process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.   "
191934|NCT00358826|"     This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various     inflammatory biomarkers in patients with recent acute coronary events   "
191935|NCT00358839|"     The aim of the present study is to explore functional consequences of migraine gene mutations     on their responses to Calcitonin Gene Related Peptide (CGRP)infusion.   "
191936|NCT00358852|"     The purpose of this study is to establish and validate a scale/model that can be used to     evaluate the duration of time and factors between short term hospital treatment and     subsequent relapse periods in patients with schizoaffective/schizophreniform disorders.   "
191937|NCT00358865|"     The purpose of this study is to check the usability of Virtual Reality (VR) Video Capture     Projected System in children with acquired brain injury(ABI)and comparing their performance     to the performance of normally developing children. The trial shall include 15 subjects in     each group, aged 6-12 years old. ABI subjects are hospitalized at the hospital's Pediatric     Rehabilitation Department Each subject will experience 3 different virtual environments. The     subjects in the trial group will practice 3 experiences (3 times in 3 different days) during     a period of a week to 10 days, to check the practice effect.In addition, all subjects will be     tested in three tests: PEDI - to evaluate the functional abilities of daily living     (dressing, eating...),The Melbourne Assessment - to evaluate functional movements of upper     extremities, and the TEA-ch - to evaluate different attention abilities. Performance     correlations will be tested between these tests and the performance in the VR first     experience.   "
191938|NCT00358878|"     Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the     treatment of clinically evident ascites in participants with cirrhosis of the liver.      Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment     period in participants with cirrhosis of the liver and ascites.      The one-year double blind placebo controlled period is extended up to 2 years in a long term     safety study (PASCCAL-2).   "
191939|NCT00358891|"     Although previous studies showed that preterm infants resolving from neonatal respiratory     disease are more likely to exhibit respiratory illness, developmental disorders, impaired     growth and cognitive limitations compared with those without, the information concerning the     longitudinal respiratory and neurodevelopmental outcome of recently survived preterm infants     with CLD is limited.Therefore, the purpose of this study is threefold. First, VLBW infants     with CLD, VLBW infants without CLD and full-term infants will be examined for respiratory     health at 3-5 years old and will be assessed the relations of early respiratory and     environmental variables with later respiratory outcome. Secondly, all infants will be     examined for neurodevelopmental outcome, and will be assessed the relations of early     neuromotor and environmental variables with later neurodevelopmental outcome. Thirdly, the     VLBW infants will be assessed for the concurrent and consecutive longitudinal relationships     between respiratory and neurodevelopmental measures.   "
191940|NCT00358904|"     Subjects who have had the Weber osteotomy for Hill-Sachs lesions will have CT of Both     shoulders. Amount of rotation in operative shoulder will be compared to contralateral. QOL     will be assessed   "
191941|NCT00358917|"     The purpose of this study was to compare the safety, tolerability, and antiviral activity of     once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet     formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors     (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects     with detectable viral load while receiving their current antiretroviral therapy.   "
191942|NCT00358930|"     This is a Phase 2, multi-center, open label study of ARQ 501 in patients with locally     advanced, recurrent or metastatic squamous cell cancer of the head and neck (SCCHN).   "
191950|NCT00359034|"     We are interested in determining if we can measure the blood flow in the descending aorta     (large blood vessel in the abdomen) of healthy fetuses and fetuses with growth restriction.     An increasing number of adult diseases (e.g. heart and blood vessel disease) are recognized     as potentially associated with fetal growth and development.      Pulse wave velocity (PWV) is a measure of blood flow in blood vessels. This is routinely     measured in adults, and has recently been studied in children. The purpose of our study is to     see if we can develop a simple ultrasound method to measure the PWV in fetuses.      The purpose of this study is to see if we can consistently measure the blood flow patterns in     the fetal descending aorta (large blood vessel in the abdomen) of 20 healthy fetuses and 20     growth restricted fetuses using standard ultrasound techniques.   "
191951|NCT00359047|"     The aim of the ROCQ programme is to improve the use of evidence based osteoporosis diagnostic     and treatment strategies for women 50 years and over who have suffered a fragility fracture.     This objective will be achieved by concentrating on a realistic evaluation of the present     diagnosis and treatment rate of osteoporosis following a fragility fracture and comparing it     to an optimal situation (care gap) and proposing interventions that promote new approaches to     treating osteoporosis by health professionals as well as providing targeted interventions for     the patient. The efficacy of these interventions will be evaluated using a randomized control     design.   "
191952|NCT00359060|"     Purpose of the SHAPE study is to examine the effects of an 1-year exercise programme on     endogenous hormone levels associated with breast cancer among sedentary postmenopausal women     and whether a decrease in intra-abdominal fat is associated with a lowering of these hormone     levels.   "
191953|NCT00359073|"     People with asthma may have asthma worsening when they have an upper respiratory infection     due to a virus or a common cold. Leukotrienes are increased in nasal secretions from children     with Respiratory Syncytial Virus (RSV) and lung washings during times of acute lung     inflammation. Experimental virus exposure in adults is also associated with increases in     nasal leukotrienes.      The degree to which leukotrienes play a role in asthma worsening is unknown.There is     information linking leukotrienes to viral infections, allergic inflammation, and asthma     exacerbation.This information supports the hypothesis that virus-induced leukotrienes     contribute to the severity of respiratory infections and in susceptible individuals, lead to     lower airway obstruction and exacerbations of asthma. We propose to use montelukast in an     experimental viral challenge model to explore this hypothesis.   "
191954|NCT00359086|"     In this study, MGCD0103, a new anticancer drug under investigation, is given three times     weekly to patients with relapsed and refractory lymphoma.   "
191955|NCT00359099|"     This is a retrospective chart review. We hypothesize that patients who have undergone     congenital heart surgery, prior to screening of blood products have a significant risk of     hepatitis C infection and all such patients would benefit from screening for hepatitis C.   "
191956|NCT00359112|"     This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and     metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.   "
191957|NCT00359125|"     Bipolar disorder is a chronic and recurrent illness which involves episodes of mania and     depression. It is believed that disturbance of the stress hormone system (the     hypothalamic-pituitary-adrenal or HPA axis) may cause thinking and memory problems and make     the depressive symptoms worse in bipolar disorder. Early studies have shown that mifepristone     may have antidepressant effects (may improve the symptoms of depression) and may also     maintain or enhance cognition (memory and thinking functions).      The purpose of this study is to determine the potential therapeutic efficacy (usefulness) of     mifepristone in bipolar depression by assessing the effects of the medication on depressive     symptoms and on cognition. This will be done by questionnaires and thinking tests.      This study will also try to clarify the functional changes that accompany bipolar disorder by     analyzing saliva samples (assessing the stress response by measuring the levels of 2 stress     hormones: cortisol and DHEA).   "
191958|NCT00359138|"     This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single     center study in subjects with positive histamine skin prick test and a positive     RadioAllergoSorbent Test (RAST) (class > 2) to one of the tested standardized allergenic     extracts: tree pollen, cat dander, house dust mite, or a mixture of five grass pollens.     Subjects will be randomized to desloratadine 5 mg once daily, levocetirizine 5mg once daily,     or placebo once daily for 8 days of treatment followed by 11 days of skin testing after     discontinuation of the antihistamine treatment phase. The duration of the suppressive effects     of desloratadine on cutaneous allergen-induced wheal and flare responses after     discontinuation of a one-week treatment will be established.   "
191959|NCT00359151|"     This study will investigate the benefits of administering celecoxib (Celebrex), a selective     cyclooxygenase -2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing     elective unilateral primary total knee arthroplasty (TKA) from the pre-operative phase to the     management of post total knee replacement pain, and through the 6 weeks of physical therapy     and rehabilitation.   "
191960|NCT00359164|"     To determine if Visudyne photodynamic therapy (low or very low fluence rate) combined with     intravitreal injections of bevacizumab (Avastin) compared with bevacizumab alone will, with     similar safety and efficacy, delay time to retreatment with bevacizumab after the initial     treatment, in subjects with new wet AMD Hypothesis: PDT in combination with Avastin at either     the low or very low fluence rate will delay time to retreatment and reduce the average number     of treatments required, compared to Avastin alone, but will have a similar safety and     efficacy profile.   "
191961|NCT00359177|"     The purpose of the study is to evaluate how subjects with mild or moderate liver problems     process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.   "
191962|NCT00359190|"     This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream     mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer     patients for three dosing schedules of lapatinib.   "
191963|NCT00359203|"     ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to     assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated     syncope.   "
192087|NCT00362505|"     The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24     weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up     period   "
191964|NCT00359216|"     This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind     study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with     Sleep-disordered Breathing (SDB) associated with perennial allergic rhinitis (PAR) using Peak     Nasal Inspiratory Flow (PNIF), Embletta device home-monitored cardiopulmonary evaluations,     and rhinitis evaluations and questionnaires. Approximately 30 subjects 18 to 60 years of age     with symptomatic PAR (with or without SAR) will be selected and randomized at one study site.     The anticipated duration of subject participation in the study is approximately 39 days.     Subjects who qualify at the Screening Visit will complete a 10-14 day run-in/screening     period. Following the run-in period, subjects who meet the qualifications at the Baseline     Visit will be treated with study medication for 4 weeks.   "
191965|NCT00359229|"     Primary objective:      1. To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in     China      Secondary objectives:        1. To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in          China.        2. To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia          in China   "
191966|NCT00359242|"     Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even     among very young children. Because the current evidence base regarding potentially effective     early intervention components to prevent obesity is so incomplete, it is logical to initiate     obesity prevention intervention research during infancy, focusing on the two major components     of the infant lifestyle, sleeping and feeding.   "
191967|NCT00359255|"     This study would focus on a new method of adding extra arm exercise to the usual therapy     delivered in the hospital. We propose to design an exercise program for the affected arm and     hand that would be given to the client as homework and done in the client's hospital room.     The program would be designed and monitored by a therapist that works in the hospital.      We believe that this program will: 1) increase arm and hand recovery over usual care received     in the hospital, 2) help people make the move from therapist run exercise to self management     of exercise, and 3) promote family involvement in therapy.   "
191968|NCT00359268|"     This study will try to identify new or known viruses responsible for diseases or conditions     of unknown cause. Viruses are an important cause of illness. They have been identified as     causes of several cancers, including certain liver cancers and cervical cancer. Several     diseases, such as Kawasaki s disease, aplastic anemia, aphthous ulcers, and certain fevers of     unknown origin in immune suppressed patients are thought possibly to be due to viruses, but     their cause has not yet been determined. This study will use very sensitive molecular     techniques to try to identify new or known viruses in patients with conditions of unknown     causes. This study does not involve any treatment.      Any patient with a condition or disease whose cause is unknown may be eligible for this     study. A referral from a local physician is required for patients who wish to enroll in this     study.      Participants will have blood samples drawn up to four times during the study. The total     amount of blood drawn in any 6-week period will not exceed 50 milliliters (about 3-1/2     tablespoons) for adults and 5 ml (about 1/2 tablespoon) per kilogram (2.2 pounds) for     children. In addition, body fluids, such as joint or spinal fluid, or tissue samples, such as     biopsy specimens, obtained previously for medical purposes, may be obtained for testing.      The patient s doctor will be informed of any positive findings from the samples.     Identification of a virus does not necessarily mean that the virus is causing the patient s     condition or disease. Additional tests from many patients with similar diseases or conditions     are required before a virus can be definitively associated with a disease. Similarly, failure     to find a virus does not necessarily mean that the patient is not infected with a virus that     is causing the condition, as the tests used in this study are imperfect and will not detect     certain forms of viruses that can cause disease.   "
191969|NCT00359281|"     This phase II, open-label research study was conducted in 129 healthy volunteers. Each     subject will be given one initial oral dose of one of 7 FDA-approved medications (probe     drugs), followed by a 7 day period where subjects receive the study medication AEGR-733 at 10     or 60 mg. On study day 8 subjects will receive the second oral dose of the same probe drug     that was given on day 1 and a last dose of AEGR-733 (total of 7 doses).Subjects will return     in 1 week for a final safety visit. Each FDA- approved probe drug will be given to ten (10)     or fifteen (15) subjects.      Safety, pharmacokinetic and pharmacodynamic assessments will be performed.   "
191970|NCT00359294|"     Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study.     The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and     recommended dose (RD) of PM00104, administered intravenously over 1 hour daily for 5 days     every 3 weeks (this is considered as 1 cycle) to subjects with advanced malignant solid     tumors or lymphoma.   "
191971|NCT00359307|"     The purpose of this study is to identify genes associated with certain risk factors for     atherosclerosis (hardening of the arteries) and its consequences, such as development of     coronary artery disease, heart attack, other blood vessel disease and stroke.      People enrolled in the Framingham Heart Study in Framingham, Massachusetts, are eligible to     participate in this study. They will undergo a medical history, including review of their     medical records and a family history; evaluation of memory and mood; breathing test and     electrocardiogram (EKG); blood and urine tests, including blood sample collection for DNA     (genetic) testing; evaluation of gait (walking), balance and hand grip strength; and hearing     test. They will also fill out questionnaires on their eating habits and general health.      Any patients who may suffer a stroke during the study will be examined during their     hospitalization and at 3, 6, 12, and 24 months after the stroke. This examination includes a     neurological evaluation, assessment of ability to perform daily living tasks and, possibly,     magnetic resonance imaging (MRI) of the brain, a test that uses a strong magnetic field and     radio waves to produce pictures of the brain.   "
191982|NCT00359450|"     BMS-275183 given orally twice weekly to patients pretreated for locally advanced or     metastatic NSCLC will show anti-tumor activity in any of the 3 separate cohorts of the     patients enrolled:        -  Cohort I: Patients previously treated with one taxane containing regimen.        -  Cohort II: Patients previously treated with a platinum based but non-taxane containing          regimen.        -  Cohort III: Patients previously treated with both a chemotherapy regimen and one          EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) compound.      Patients in cohorts I and II should have not been treated with a prior EGFR-TKI compound.     Prior treatment with a VEGFR (vascular endothelial growth factor receptor) inhibitor compound     is allowed for all the patients provided that the VEGFR inhibitor is not also an EGFR     inhibitor.   "
191983|NCT00359463|"     The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down     in the body by healthy subjects versus subjects with mild, moderate or severe liver problems.     The study is also being done to 1) check on how well the study drug is tolerated by healthy     subjects versus those with liver problems and 2) to check if liver impairment affects how the     study drug binds to protein in the blood.   "
191973|NCT00359333|"     Study Design Type of Study This is an open-label, single arm, prospective, multiple-center     phase II study      Duration of the Study Period in One Subject Treatment duration is planned for six cycles,     unless there is evidence of disease progression or unacceptable toxicity. Patients with     continued response after six cycles could receive two additional cycles of therapy. In case     complete response and in the absence of unacceptable toxicity, treatment will be continued     for at least 2 further cycles to achieve the minimal of 6 total cycles.      Study Objectives Primary Objective The primary objective is to determine the response rate of     sequential gemcitabine and docetaxel combination in patients with locally advanced/metastatic     soft tissue sarcoma or imatinib mesylate refractory GIST.      Secondary Objectives The secondary objectives of this study are to determine the time to     progression in patients treated with this regimen, the toxicity of this regimen in these     patients, the overall survival and the quality of life.      Molecular analysis of genetic aberration in soft tissue sarcoma The genetic aberrations of     soft tissue sarcoma as reported in literature will be determined. The genetic aberration will     be correlated to chemotherapy responses.      c-kit and PDGFR gene mutations induced by imatinib mesylate and chemotherapy Those acquired     gene mutation of c-kit and PGDFR induced by imatinib mesylate will be first determined. We     will also examine further gene mutation of c-kit and PGDFR caused by combination     chemotherapy.   "
191974|NCT00359346|"     This study will explore whether an antibody is influencing the autonomic nervous system, and     if its removal will eliminate signs and symptoms of failure in that system. The autonomic     nervous system is responsible for many automatic changes involved in everyday activities,     such as standing up, digesting food, and exercising in the heat. Antibodies fight germs but     sometimes cause health problems. Removal of the antibody is done through a procedure called a     plasma exchange.      Patients with primary chronic autonomic failure and a circulating antibody to what is called     the neuronal nicotinic receptor may be eligible for this study. To be eligible, patients will     have participated in an earlier study, protocol number 03-N-0004. Patients will undergo tests     and procedures that include an electrocardiogram, and blood collection for hepatitis, HIV,     and pregnancy. Blood will be tested for a complete blood count, clotting factors, and     chemistries. There will also be tests for liver function, kidney function, cortisol, and     thyroid. Participants will be tested for signs and symptoms of autonomic failure, and will be     asked to complete questionnaires about various symptoms before the plasma exchange, 1 or 2     weeks afterward, and then monthly or bimonthly for up to 1 year. Patients will undergo a     series of other tests. In one test, a patient is upright and blows against a resistance     (Valsalva maneuver). The quantitative sudomotor axon reflex test (QSART) uses iontophoresis,     involving application of acetylcholine, a chemical messenger, and a small amount of     electricity. QSART examines the regulation of sweating, a particular aspect of the autonomic     nervous system. There will be a test using edrophonium, given intravenously (IV), to evaluate     that drug's effects on the heart, skin, glands, gastrointestinal activity, bladder tone, and     salivation. A glucagon test, also by IV, will show patients' ability to release the hormone     adrenaline.      The plasma exchange will be performed by use of an automated cell separator. Patients' blood     will be removed continuously through a needle in the arm. Blood cells will be separated from     the plasma by a spinning process and continuously returned to circulation through a needle in     the patients' opposite arm. Blood cells that are returned will be mixed with albumin, a     sterile replacement solution. A blood thinner, citrate, will be given, to prevent clotting of     blood. This whole procedure will take about 2 hours. Patients will typically undergo five     exchange procedures in about 10 days while they are inpatients at the NIH Clinical Center.     The amount of plasma removed in a single session and the number of sessions will be set by     the NIH Blood Bank. It is expected that patients' autonomic failure will improve after     several days of starting the plasma exchange. Testing for symptoms of autonomic failure and     autonomic function testing will occur about 1 month after the plasma exchange and monthly or     bimonthly for up to 1 year. For each visit of testing, patients will be inpatients for about     2 days. If autonomic failure recurs, patients may have a second plasma exchange, with the     same follow-up tests, for about 1 year.   "
191975|NCT00359359|"     The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH     Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in     patients who did not receive prior treatment for their lung cancer   "
191976|NCT00359372|"     This study will explore which characteristics of patients with heart failure will likely     predict improvement after cardiac resynchronization (CRT), implantation of a pacemaker to     improve heart function. In spite of major medical advances, about 30% to 40% of patients with     heart failure do not respond to CRT, and the reasons are not well understood. This study will     involve magnetic resonance imaging (MRI), electrocardiogram (ECG), and echocardiography     techniques to let researchers examine what may influence response to CRT.      Patients ages 18 and older with a left ventricular disorder and who are not pregnant or     breastfeeding may be eligible for this study. Initial evaluation will take 5 to 6 hours. A     blood sample of about 2 tablespoons will be collected, and several procedures will be     performed. MRI uses a strong magnetic field and radio waves to obtain images of body organs     and tissues. For that procedure, patients will lie on a table that slides into the enclosed     tunnel of the scanner and be asked to lie still. They will be in the scanner for 30 to 90     minutes. As the scanner takes pictures, patients will hear knocking sounds, and they may be     asked to hold their breath intermittently for 5 to 20 seconds. During part of the scan, a     drug called gadolinium will be given intravenously (IV), to make the heart easier to see.     Patients will be able to communicate with the MRI staff at all times during the scan. At any     time, patients may ask to be moved out of the machine. Patients having metal in their body     that interferes with the MRI scanner should not have this test. During the procedure, an ECG     machine will monitor the heart, through wires connected to pads on the skin. Patients will     have an echocardiogram, in which sound waves look at the heart. A small handheld probe will     touch the chest and abdomen, and an IV tube may be inserted to inject a contrast drug to     improve the quality of heart images. Patients will have a cardiopulmonary stress test     (treadmill test) and a 6-minute walk test, both before pacemaker implantation and then 6     months afterward. Also before and after pacemaker implantation, patients will complete the     Minnesota Living with Heart Failure Questionnaire, regarding the impact of heart failure on     patients' lives. The follow-up visit will take 3 to 4 hours.   "
191977|NCT00359385|"     We are investigating whether, after surgical cure of primary hyperparathyroidism, alendronate     provides even greater beneficial skeletal effects than parathyroidectomy alone.      Primary Hyperparathyroidism (PHPT) is a disorder that can be associated with bone loss. After     successful surgery for PHPT bone density improves without any treatment. However, it is     possible that bone density might improve to an even greater extent if Fosamax is used after     the surgical cure. Fosamax is approved by the FDA for the prevention and treatment of     osteoporosis, and the goal of this project is to determine whether after successful surgical     cure of PHPT, Fosamax is even better for the skeleton than just parathyroid surgery alone.   "
191978|NCT00359398|"     Excessive bleeding is common after cardiac surgery. This may result in patients receiving a     blood transfusion or suffering the life-threatening complication of cardiac tamponade.     Tamponade is when excessive bleeding compresses the heart and prevents it from pumping     properly. A major reason for the bleeding is the damage done to platelets by the     cardiopulmonary bypass (CPB) machine. Often patients receive platelets and plasma from blood     donors to try to reduce the bleeding post-operatively. The investigators plan to take     platelets and plasma from patients before they are damaged. They would then return these     'undamaged' sequestered platelets to the patients after the bypass machine is no longer     needed. Therefore, the investigators' primary question is whether platelet sequestration     would reduce the bleeding problems that occur following cardiac surgery. They will evaluate     bleeding problems using thromboelastography, which provides a comprehensive assessment of     both how blood clots form and their strength. If sequestration reduces bleeding problems     following cardiac surgery then it may reduce the chance of patients receiving blood products     from donors. Although donated blood is thoroughly tested, its use does expose patients to the     risk of transfusion errors, blood borne infections and reactions. Avoiding its use would be     very desirable.   "
191979|NCT00359411|"     This study will study the effects of the gene on the X chromosome that is associated with     X-linked lymphoproliferative disease (XLPD)-an inherited disease affecting the immune     system-on the function of the immune system. XLPD has been linked to an abnormality in a     specific region of the X chromosome (one of 23 chromosome pairs that contain the genes that     determine a person's hereditary makeup). The disease may develop after infection with the     Epstein-Barr virus (EBV). EBV affects more than 95 percent of people in the United States. It     usually does not cause any symptoms in children. In adolescents and adults, however, EBV can     cause infectious mononucleosis and sometimes lymphoproliferative disease, such as XLPD. In     these diseases lymph tissues, such as lymph nodes, may become enlarged and immune function     (infection-fighting ability) impaired. This study will compare DNA from patients with XLPD     with that of their unaffected relatives, of patients with other lymphoproliferative diseases     and of normal controls.      Patients of any age with XLPD, their unaffected relatives 18 years of age and older, and     patients with other lymphoproliferative diseases may participate in this study.      Blood samples will be collected from all participants to study the effects of the gene on the     X chromosome that appears to be abnormal in XLPD on the function of the immune system. In a     6-week period, no more than 100 milliliters (about 7 tablespoons) of blood will be drawn from     adults and no more than 1 ml (1/6 teaspoon) of blood per pound of body weight from children.     Blood from patients with XLPD and their relatives will also be tested for HLA type (similar     to blood type testing) and the ability of HLA-matched cells from patients and relatives to     interact will be examined.   "
191986|NCT00359515|"     This study will investigate the genetic basis of oculocerebrorenal syndrome of Lowe (OCRL)-a     rare X-linked disorder (carried by females and passed to males). Patients with OCRL have     abnormal development of the eye lens, developmental delay, muscle weakness and kidney     dysfunction.      The study will examine DNA and cell samples obtained and archived from patients with OCRL     enrolled in a previous protocol (HG008A) between 1996 and 1999. It will identify mutations in     the OCRL1 gene responsible for OCRL in affected males and try to correlate them with specific     biochemical or cellular activities (e.g., enzyme activity, protein stability, cellular     localization and trafficking). When test results are available, the information will be     communicated to the patients, their parents (if the patient is a minor) and their physicians,     and families will receive genetic counseling.   "
191987|NCT00359541|"     This study will look at how voriconazole, a drug used to treat or protect against fungal     infections, affects the body. Adverse effects associated with voriconazole include skin     problems and temporary changes in vision, mental status and liver function. There is some     evidence that these side effects may be more intense when there are high levels of the drug     in the blood. The amount of voriconazole in the body is determined by how much of the drug     the patient receives and by the patient's ability to inactivate and excrete it, which may be     determined in part by genes. This study will examine: 1) side effects patients develop from     voriconazole; 2) whether the side effects experienced are related to the concentration of     drug in the body; and 3) the role of genes in determining how quickly the body inactivates     and excretes the drug.      Patients 12 and older who are participating in studies in the National Institute of Allergy     and Infectious Diseases (NIAID), the National Cancer Institute (NCI) or the National Heart,     Lung, and Blood Institute (NHLBI) and have been treated with voriconazole for 15 days or less     may be eligible for this study.      Participation involves the following:        -  Identification and recording of adverse effects patients experience due to voriconazole          treatment        -  Collection of basic information about the patient's medical history and treatment        -  Blood draws once a week during the patient's hospitalization        -  Collection of routine laboratory test results ordered by the patient's doctor        -  Blood draw to identify genes responsible for voriconazole inactivation        -  Weekly monitoring for the possibility of voriconazole adverse effects        -  Blood draw to measure blood levels of voriconazole when the drug is stopped, if it is          stopped because of an adverse effect        -  Evaluations at outpatient visits, including a blood draw to measure voriconazole blood          levels      Participation in the study ends 7 days after voriconazole treatment is stopped because it is     no longer needed.   "
191988|NCT00359554|"     The objective of this study is to demonstrate that influenza vaccination of nursing home     workers is an effective intervention for reducing mortality of elderly people.   "
191989|NCT00359567|"     To compare palonosetron with granisetron hydrochloride as a control in the efficacy of     intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as     nausea and vomiting induced by highly emetogenic chemotherapy.   "
191990|NCT00359580|"     The purposes of this study are to identify the genes responsible for several inherited     disorders commonly seen in the Amish and Mennonite populations and learn more about the     natural history (medical problems that develop over time) of these disorders. In addition,     researchers will establish a computer database containing Amish genealogies, derived largely     from the community s extensive records of births, marriages, deaths, etc., that will help     construct pedigrees (family trees) for genetic study.      The Amish and Mennonite peoples have a high rate of intermarriage within their individual     communities, with a resulting high incidence of inherited disorders. Many of these disorders,     such as cartilage-hair hypoplasia, Ellis-van Creveld syndrome, and others, are rarely seen     outside these communities. New research using state-of-the-art methodologies in genetics will     add to current knowledge about the causes and symptoms of these disorders that will     eventually aid in their diagnosis and medical management.      Patients with inherited disorders that occur frequently in the Amish and Mennonite     populations and their family members may be eligible for this study. Individuals from both     within and outside these communities may enroll.      Participants will be evaluated with a review of their medical records and their personal and     family medical history and a brief physical examination. A small tissue sample will be     collected for genetic studies. This will be either a blood sample (3 teaspoons from adults     and 1 to 3 teaspoons from children, depending on their size) or a mouth swab (cells removed     from inside the cheek by gentle brushing). Some participants may undergo additional     procedures, such as diagnostic X-rays, brain scans, echocardiogram (heart ultrasound) or     other studies.      If genetic testing shows a gene change (mutation), the participant will be notified to that     effect in writing and offered counseling in their home regarding the test results and their     implications.   "
191991|NCT00359593|"     The aim of this project is to evaluate whether using an implementation intervention promotes     use of best practices by rehabilitation professionals and leads to improvements in patient     outcomes for individuals with stroke.   "
191992|NCT00359606|"     This phase I trial studies the side effects and best dose of 5-fluoro-2-deoxycytidine when     given together with tetrahydrouridine in treating patients with solid tumors that have spread     to other places in the body and usually cannot be cured or controlled with treatment     (advanced). Drugs used in chemotherapy, such as 5-fluoro-2-deoxycytidine and     tetrahydrouridine, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading.   "
191993|NCT00351936|"     This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of     the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated     patients with schizophrenia or schizoaffective disorder. The advantage of the crossover     design is that each subject will act as their own control and fewer subjects will be required     than a between-group design.   "
191994|NCT00351949|"     Single-center, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in     ambulatory and day-hospital setting   "
191996|NCT00351975|"     This phase I trial is studying the side effects and best dose of belinostat when given     together with azacitidine in treating patients with advanced hematologic cancers or other     diseases. Belinostat may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy,     such as azacitidine, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving belinostat together with     azacitidine may kill more cancer cells.   "
191997|NCT00351988|"     The primary objectives are to:      1.1 identify and compare the experiences of minority and nonminority caregivers, including     the prevalence and severity of physical (fatigue, sleep disturbance) and psychologic     (depression, anxiety, stress) symptoms and their influence on caregiver symptom burden; and     to      1.2 assess the relationship between caregiver's symptoms (physical and psychologic) and the     patient's symptom's at multiple time points over the patient's treatment regimen for advanced     solid tumors (lung, breast, cervical, and others).      A secondary objective is to:      1.3 describe the experience of being a minority (African American/Black or Latino) or     nonminority person caring for a medically underserved patient with advanced solids tumors     (lung, breast, cervical, or others) over the course of the patient's treatment regimen and     follow-up clinic visits.   "
192012|NCT00359658|"     The purpose of this study is first to improve or save renal function and second to decrease     cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and     reducing the Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an     effective immunosuppressive agent, will minimize the risk of acute rejection episodes.   "
191998|NCT00352001|"     RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the     cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer     cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways     to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Azacitidine may also cause cancer cells to look more like normal cells, and to grow     and spread more slowly. Giving lenalidomide together with azacitidine may kill more cancer     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide and     azacitidine in treating patients with advanced myelodysplastic syndromes.   "
191999|NCT00352014|"     The purpose of this study is to investigate whether the level of Platelet Inhibition as     assessed with five point-of-care platelet function assays correlates with clinical     (periprocedural) outcomes such as Acute Myocardial Infarction, death, Target Vessel     revascularization and/or stroke in patients undergoing elective PCI.   "
192000|NCT00352027|"     The main purpose of this protocol is to estimate the percentage of patients with intermediate     risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years     after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field     radiation therapy. The hypothesis being studied is that this treatment will result in more     than 80% of patients being alive and free of disease three years after starting treatment.   "
192001|NCT00352053|"     The purpose of this study is to assess the safety and efficacy of tenofovir disoproxil     fumarate (tenofovir DF; TDF) plus a genotype-guided optimized background regimen (OBR)     compared to placebo plus OBR in the treatment of human immunodeficiency virus type 1 (HIV-1)     infected antiretroviral treatment-experienced adolescents with plasma HIV-1 ribonucleic acid     (RNA) levels greater than or equal to 1000 copies/mL.   "
192002|NCT00352066|"     The aim of the study is to see if apricitabine or tipranavir affect the levels of each other     in the blood (pharmacokinetic interaction) when they are dosed together.   "
192003|NCT00352079|"     RATIONALE: Biological therapies, such as BCG, may stimulate the immune system in different     ways and stop tumor cells from growing. Gefitinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Giving BCG together with gefitinib may     kill more tumor cells. It is not yet known whether BCG is more effective with or without     gefitinib in treating bladder cancer.      PURPOSE: This randomized phase III trial is studying BCG and gefitinib to see how well they     work compared to BCG alone in treating patients with high-risk bladder cancer.   "
192004|NCT00352092|"     The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and     calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney     transplant from a living donor that is HLA-identical (has a similar immune system).   "
192005|NCT00352105|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     cisplatin, fluorouracil, and gefitinib together with radiation therapy may kill more tumor     cells.      PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin,     fluorouracil, and gefitinib together with hyperfractionated radiation therapy and to see how     well they work in treating patients with locally advanced head and neck cancer.   "
192006|NCT00352118|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving combination chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with radiation therapy works in treating patients with locally advanced head and neck cancer.     The doctor also wants to find out if patients who receive this treatment need a feeding tube     1 year after starting treatment.   "
192007|NCT00352131|"     RATIONALE: Monoclonal antibodies, such as maytansinoid DM4-conjugated humanized monoclonal     antibody huC242, can block tumor growth in different ways. Some block the ability of tumor     cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them.      PURPOSE: This phase I trial is studying the side effects and best dose of maytansinoid     DM4-conjugated humanized monoclonal antibody huC242 in treating patients with solid tumors     that cannot be removed by surgery or have spread to other parts of the body.   "
192008|NCT00352144|"     To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects     with primary insomnia on subjective sleep measures, compared to placebo.   "
192023|NCT00359814|"     The purpose of this study is to improve or save renal function by optimizing the     immunosuppressive regimen by reducing the Cyclosporine A dose and the exchange of     Azathioprine by Mycophenolatmofetile, which is an effective immunosuppressive agent and will     minimize the risk of acute rejection episodes.   "
192009|NCT00359619|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the     uterus or womb). This infection may go away by itself, but if it does not go away (this is     called persistent infection), it can lead in women over a long period of time to cancer of     the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic     types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also     evaluating novel HPV vaccines formulations. This study will evaluate the long-term     immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects     who received the novel vaccine or the control vaccine administered in the primary study.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
192010|NCT00359632|"     To understand and characterize the effects of linezolid on the optic nerve by observing and     following patients who have been treated with linezolid for six weeks or longer for the     development of signs or symptoms of visual disturbance or eye disorders.   "
192011|NCT00359645|"     Randomized multicenter trial to assess the impact of a screening program for heavy alcohol     drinkers and smokers treated in alcohol addiction clinics on upper aerodigestive tract cancer     mortality.   "
192014|NCT00359684|"     Cystinosis is an inherited disease resulting in poor growth and kidney failure. There is no     known cure for cystinosis, although kidney transplantation may help the renal failure and     prolong survival. Both the kidney damage and growth failure are thought to be due to the     accumulation of the amino acid cystine within the cells of the body. The cystine storage     later damages other organs besides the kidneys, including the thyroid gland, pancreas, eyes,     and muscle.      The drug cysteamine (Cystagon) is an oral medication given to patients with cystinosis prior     to kidney transplantation. The drug works by reducing the level of cystine in the white blood     cells and muscle tissue. The drug may also decrease levels of cystine in the kidneys and     other tissues.      This study has several goals:        1. <TAB>Long-term surveillance of cysteamine (Cystagon) treated patients.        2. <TAB>Detection of new non-kidney complications of cystinosis.        3. <TAB>Maintenance of a patient population for genetic testing (mutational analysis) of          the cystinosis gene.<TAB>   "
192015|NCT00359697|"     The overall purpose of this study is to compare the effects of mannitol and hypertonic saline     on patients with increased intracranial pressure. The hypothesis being tested is that     hypertonic saline is more effective in controlling increased intracranial pressure than     mannitol.   "
192016|NCT00359710|"     This study will collect the opinions, understandings and personal health care experiences of     multiracial persons of African and European ancestry. Understanding multiracial patients'     beliefs and experiences about their race, ethnicity, ancestral origin and the genetic     components of diseases can provide important data for developing ways to communicate how     human genetic variation is related to self-identified race and ethnicity. The study will:        -  Investigate multiracial individuals' beliefs about biological and genetic differences          based on race and ethnicity;        -  Collect stories of identity, ancestry and clinical experiences of multiracial          individuals with one parent of African ancestry and one parent of European ancestry;        -  Investigate multiracial patients' experiences regarding family health history and          communication of genetic risk of disease.      Persons 21 years of age or older in the Atlanta, Georgia, or Washington, D.C., metropolitan     areas who are from a multiracial background and have used health care services in the last 2     years may be eligible for this study. Participants are interviewed one-on-one for about 2     hours to gather information about their background, family ancestry, self-identity, race and     ethnicity, health care interactions and genetics and health. Each participant completes a     short questionnaire before and after the interview.   "
192017|NCT00359723|"     The purpose of this trial is to determine if methylphenidate (MPD), a drug marketed in the     U.S. to treat hyperactivity and narcolepsy, added to levodopa, will increase the beneficial     effects of levodopa without bothersome side effects in people with Parkinson's disease (PD).   "
192018|NCT00359736|"     Medicines that decrease blood pressure in the lungs may help idiopathic pulmonary fibrosis     (IPF) patients function better. This study will test whether sildenafil improves the ability     to exercise in patients with pulmonary fibrosis of unknown cause.   "
192019|NCT00359762|"     This study assesses the effects of twice-daily subcutaneous injection exenatide versus     treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell     function.   "
192020|NCT00359775|"     Purpose of the study The purpose of this study is to pilot an adapted Coping Skills Training     (CST) intervention for feasibility and preliminary efficacy with a sample of children 8 to 12     years of age and their parents. The participants in this study at Children's Hospital of     Wisconsin are dealing with one of three chronic health conditions (Rheumatologic Conditions,     Epilepsy,Spina Bifida, and Asthma).      Research Questions/Study Aims      The research questions addressed in the full study are:        1. What is the impact of CST on child depression, QOL, health motivation, attitude toward          illness, and self-management efficacy?        2. What is the impact of CST on parent depression, perception of child's quality of life,          perception of impact of CHC on family, and family conflict?   "
192021|NCT00359788|"     The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with     tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler     (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic     Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.   "
192022|NCT00359801|"     The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of     Exubera in routine clinical practice.   "
192024|NCT00359840|"     To assess the clinical effective dose of KRN321 administered with once triweekly schedule.   "
192025|NCT00359853|"     Advanced liver disease and low ascitic fluid protein concentration have been identified as     risk factors for spontaneous bacterial peritonitis in cirrhosis. Moreover, renal impairment     and hyponatremia increase mortality rate of this infection. Aims: To investigate if oral     administration of norfloxacin prevents the first episode of SBP, hepatorenal syndrome and     improves survival in cirrhotic patients with ascites and low protein concentration in ascitic     fluid (<15 g/L) and at least one of the following inclusion criteria: functional renal     failure (serum creatinine ≥ 1,2 mg/dl or BUN ≥ 25 mg/dl), hyponatremia (serum sodium ≤ 130     mEq/L) or advanced liver disease (Child ≥ 9 points with serum bilirubin ≥ 3 mg/dl). Methods:     Prospective, multicenter, randomized, double-blind placebo controlled trial comparing oral     norfloxacin (400 mg/d; n=35) with placebo (n=35).   "
192034|NCT00359970|"     In a previous study azithromycin proved as efficacious as levofloxacin in the treatment of     travelers' diarrhea in Mexico. Because the addition of loperamide to some antibiotics (e.g.,     trimethoprim-sulfamethoxazole and ofloxacin) has proven more efficacious than antibiotic     alone in the treatment of travelers' diarrhea, we decided to study the addition of loperamide     to azithromycin.      US adults with acute diarrhea in Guadalajara Mexico were randomized to receive azithromycin     in two different doses or loperamide plus azithromycin.      The duration of diarrhea was shorter (11 hours) in the combination-treated group compared to     the antibiotic-treated groups (34 hours). The percentage of subjects continuing to pass 6 or     more unformed stools in the first 24 hours was less (1.7%) in the combination-treated group     than in the antibiotic-treated groups (20%).      We feel loperamide should routinely be added to an antibiotic to optimize treatment of     travelers' diarrhea.   "
192151|NCT00363363|"     The purpose of this study is to determine which is the most effective intervention for     increasing lifestyle physical activity in Fontan patients: an education (stage of change)     intervention or a physical activity (mastery experience) intervention.   "
192026|NCT00359866|"     Indications for post-hysterectomy radiation therapy (RT) have been well established by     clinical data. Adjuvant RT has demonstrated local control and survival benefit. In patients     with nodal disease, adjuvant chemotherapy concurrent with radiation has further improved the     clinical outcome. The acute hematological and gastrointestinal toxicity of concurrent     chemo-radiotherapy can be quite high, sometimes preventing patients from completed their full     treatment course, potentially compromising the therapeutic benefit of treatment. Intensity     modulated radiation therapy (IMRT) is an advanced method of delivering external beam     radiation that may minimize the volume of normal tissue irradiated to high dose and thus     decrease the risk of normal tissue toxicity. Helical tomotherapy is a novel treatment device     with sophisticated imaging and treatment delivery features that are optimally suited for     IMRT. There are retrospective clinical data supporting the use of non-tomotherapy delivered     IMRT to treat patients with gynecologic cancers. The proposed study will prospectively test     whether helical tomotherapy is a feasible method for delivering IMRT in post-hysterectomy     cervical cancer patients receiving adjuvant RT. Here, the question of feasibility is simply     one of verifying that target volumes are reliably covered by 'sculpted' IMRT high-dose     regions. Although this is not a treatment effectiveness study, we will also follow the     clinical outcome of these patients, including toxicity, local control and survival, in     anticipation that this information will be valuable if the treatment modality is judged     feasible and will be used for further treatments of this patient population.   "
192027|NCT00359879|"     This trial is designed to compare the effects of twice-daily (before lunch and before dinner)     exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before     dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2     diabetes.   "
192028|NCT00359892|"     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow     unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process     of cell death that is often inhibited in cancer cells.      This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in     2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with     relapsed or refractory Hodgkin's Lymphoma. Infusions may be administered on an out-patient     basis. No investigational or commercial agents or therapies other than those described in the     protocol may be administered with the intent to treat the patient's malignancy. Supportive     care measures including those directed at controlling symptoms resulting from Hodgkin's     Lymphoma (blood products, growth factor, etc.) are allowed.   "
192029|NCT00359905|"     A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and     tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe     and effective (the first phase of the study lasts approximately 18 weeks) and then is used     for another 9 months to determine its long-term safety.   "
192030|NCT00359918|"     Prehospital initiated facilitation of primary percutaneous coronary intervention by     fibrinolysis might be helpful in re-opening the infarct related artery prior to percutaneous     coronary intervention.      This studies tests the hypothesis that prehospital initiated facilitated PCI is superior to     primary percutaneous coronary intervention with respect to infarct size.   "
192031|NCT00359931|"     This study will use magnetic resonance imaging (MRI) to compare brain function in three     groups of people: hearing-impaired people with tinnitus; hearing-impaired people without     tinnitus; and people with normal hearing and without tinnitus. Also known as ringing in the     ears, tinnitus is the false sensation of sounds.      Adults between 30 and 65 years of age who meet the following criteria may be eligible for     this study:        -  Mild to moderate hearing loss who have experienced tinnitus daily for at least 1 year        -  Mild to moderate hearing loss who have never or rarely experienced tinnitus        -  Normal hearing who have never or rarely experienced tinnitus      Candidates are screened with a medical history and questionnaires.      Participants have a detailed hearing test to measure hearing and the nature of tinnitus. In a     second visit, subjects have a brief physical examination, followed by MRI scanning. MRI uses     a magnetic field and radio waves to produce images of body tissues and organs. For this     procedure, the subject lies on a table that can slide in and out of the scanner (a narrow     cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the     scanning process. The subject may be asked to lie still for up to 8 minutes at a time. During     the MRI, the subject performs computer-based tasks that involve listening to sounds. Another     hearing test is done after the MRI.   "
192032|NCT00359944|"     The purpose of this study is to investigate efficacy and safety of different doses of AC-3933     in patients with mild to moderate Alzheimer's Disease.   "
192033|NCT00359957|"     The purpose of this trial is to examine whether adding greater physical activity to standard     family-based behavioral pediatric obesity treatment decreases the amount of visceral fat     among treated overweight children.   "
192044|NCT00361933|"     The purpose of the study is to learn whether people who are experiencing an MCD (multicentric     Castleman's Disease) flare will improve after taking valganciclovir. MCD is a type of     inflammatory disease associated with Human Herpesvirus 8 (HHV-8). Valganciclovir is FDA     approved for treating a different type of Human Herpesvirus, but not approved for the     treatment of HHV-8. It is therefore considered experimental in this study.   "
192070|NCT00362284|"     The purpose of this study is to determine the effectiveness of a comprehensive counseling and     support intervention for people who care for parents with Alzheimer's disease (AD) or other     dementias on outcomes such as stress, depression and ability to postpone or avoid nursing     home placement.   "
192047|NCT00361972|"     This study will evaluate how heartburn may lead to different types of inflammation in one's     airways. Additionally, the study will determine whether aggressive treatment of heartburn     results in improvement in both symptoms of heartburn and asthma but also in documented     improvement in airway inflammation as determined by biopsy. The results of this study will be     important in directing future research into the relationship between heartburn and asthma and     may provide a clue whether certain subtypes of asthma may be caused primarily by     gastroesophageal reflux (GER).   "
192152|NCT00363376|"     The specific aim of this study is to evaluate the efficacy, tolerability, and safety of     zonisamide therapy in the prevention of weight gain associated with olanzapine treatment for     psychotic or bipolar disorders.   "
192035|NCT00361816|"     Approximately 15 percent of couples experience infertility, yet no abnormalities can be     detected in the man or the woman. In a number of couples, their embryos unexpectedly slow     down growth or stop growth completely. Some of these situations may be genetically     determined. For instance, a portion of cases may be caused by poor egg quality related to     genetic or functional deficiencies in heretofore unidentified human maternal effect genes. A     model has been developed of such unexplained fertility by creating a mouse line lacking a     critical maternal effect gene. (Maternal effect genes produce mRNA or proteins that     accumulate in the egg and are required for normal early embryonic development.) This pilot     project will test the hypothesis that a similar defect may be a cause of human infertility.      Thirty cubic centimeters of blood will be collected from 40 women who have a clinical history     consistent with a defective maternal effect gene. DNA from these blood cells will be examined     and stored. Some of the blood cells will be treated so that they can be frozen and grown in     the laboratory to produce more DNA in the future. If certain mutations are not found, that     means that the prevalence of such mutations is less than 10 percent, and investigators may     initiate another study with 100 women. If a common mutation is found in at least four     patients, the investigators will seek to collect DNA from 150 normal fertile control women     for comparison.      This project is purely investigational; therefore, findings will not be shared with     participants.   "
192036|NCT00361829|"     Research and theory tend to agree when suggesting that certain activities done by mothers     have both immediate and delayed consequences for children's mental development in the first     years of life.      The everyday interaction between an infant and a caregiver can be broken down into many     categories. There are data linking both of these types of interaction to the mental     development of children.      The study will focus on the extent to which maternal characteristics (age, employment status,     parenthood status, and birth order of the child) influence the relation between maternal     social and didactic caregiving and the social and mental development of children.      Mother-infant interaction will be observed when the infants are 5 months old.      When the children are 20 months old, measures of toddler function (e.g., ability to play and     language development) and maternal behavior (e.g., encouragement of attention to the     environment and I.Q.) will be obtained.      When the children are 48 months old, researchers will measure preschooler psychosocial     functioning (e.g., I.Q., cognitive and social competencies) and maternal behavior (e.g.,     scaffolding).      Understanding the relation between children's experiences as infants, toddlers, and     preschoolers and their eventual intellectual and social functioning is an essential part of     normal developmental research.<TAB>   "
192037|NCT00361842|"     The purpose of this study is to determine whether CPX-1 is effective in patients with     advanced colorectal cancer who have already received chemotherapy that included the drug     oxaliplatin or irinotecan. All patients will receive CPX-1 at a dose of 210 units/m2 over 90     minutes every two weeks.   "
192038|NCT00361855|"     Certain types of cells located in bone marrow may help the body recover after an injury.     These cells may be able to help the body repair heart muscle that has been damaged from a     heart attack. NX-CP105 is a new investigational drug that is made up of these special types     of bone marrow cells, which come from another person. NX-CP105 has not been approved for sale     or general use by the Food and Drug Administration (FDA), and this study will be the first     time that NX-CP105 is given to human beings.      This study is being conducted to see if there are any side effects associated with with     NX-CP105 and whether NX-CP105 may help the body repair heart muscle that has been damaged     from a heart attack. Three different doses of NX CP105 will be tested in this study, starting     with the lowest dose first.      Patients who decided to participate in the study will have a heart catheterization procedure     during which a narrow tube is inserted into an artery (type of blood vessel) in the groin and     passed to the heart. A second narrow tube will be inserted into a vein (type of blood vessel)     in the groin and passed to your heart. A device will be passed through the second tube. This     device will be used to inject NX-CP105 cells directly into your heart muscle.   "
192039|NCT00361868|"     Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients     with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed     combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of     rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is     superior to that of rosiglitazone.   "
192040|NCT00361881|"     The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and     placebo for the treatment of recurrent herpes labialis.   "
192041|NCT00361894|"     The purpose of this study is to assess if 10 mg Bay 59-7939, taken once daily as a tablet, is     safe and prevents blood clot which may form after a knee replacement operation.   "
192042|NCT00361907|"     The purpose of this study is to determine the effect of Pulsatile Intravenous Insulin therapy     on circulating blood markers. These blood markers are selected due to their correlation to     and possible pathogenetic roles in vascular compromise and inflammatory malfunction in     diabetic patients.   "
192043|NCT00361920|"     The hypothesis is that patients who demonstrate steroid resistant asthma by showing little or     no improvement in lung function after a course of oral steroids have different cellular     responses to steroids than patients who are steroid sensitive. These altered responses are     the reason they demonstrate steroid resistance.   "
192100|NCT00362674|"     The purpose of this study is to evaluate the durability of antiviral activity in chronic     hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303     trial.   "
192045|NCT00361946|"     To study postprandial metabolism in lean, obese and T2DM adolescents using a mixed meal     challenge. Specifically we will be measuring the following parameters of postprandial     metabolism: 1. Postprandial glucose and triglycerides excursions 2. Gastric emptying 3.     Insulin, amylin, glucagon, GLP-1 and ghrelin secretion 4. Glucose Turnover rate   "
192046|NCT00361959|"     This is a comparator study to assess the relative efficacy of the combination product     fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations     of chronic obstructive pulmonary disease (COPD) over a two year study interval.   "
192048|NCT00361985|"     The purpose of this study is to determine whether suppressing acid production by     administration of daily proton pump inhibitors in the early post-operative period will reduce     the gastrojejunal anastomosis stricture rate in patients undergoing laparoscopic gastric     bypass surgery for morbid obesity.   "
192049|NCT00361998|"     Our guidelines in the community recommend the use of NM for the treatment of women with     community acquired UTI. While the length of treatment for uncomplicated cystitis with     quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not     sufficient papers that establish the optimal length of treatment with NM in this population.     The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the     treatment of women with uncomplicated UTI.   "
192050|NCT00362011|"     The purpose of this study is to determine whether the addition of Salvia hispanica L. Alba     (Salba) to the conventional treatment for diabetes is associated with improvement in major     and emerging cardiovascular risk factors in people with type 2 diabetes.   "
192051|NCT00362024|"     MK0952 is a phosphodiesterase type IV (PDE4) inhibitor in development for improvement of     cognitive impairment in mild-to-moderate Alzheimer's disease.   "
192052|NCT00362037|"     -  To evaluate Blood Pressure (BP) reduction to the targeted values (BP ≤ 140/90 mm Hg in          non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients).        -  To emphasize and to evaluate the benefit of Irbesartan in the reduction of left          ventricular mass index in hypertensive patients with left ventricular hypertrophy.        -  To demonstrate safety of Irbesartan in this population.   "
192053|NCT00362050|"     The trial will identify the best dose of the synthetic peroxide RBx11160 to treat     uncomplicated malaria. Patients will be treated over 7 days with daily doses of 50, 100 or     200 mg RBx11160.      The study is designed to assess the antimalarial activity and safety of 3 dose levels of RBx     11160 administered once daily for 7 consecutive days. The primary endpoint will be the time     to 90% parasite clearance. In future regulatory studies, RBx 11160 is likely to be     administered in combination with another antimalarial agent since the development plan     follows the current recommendation of WHO for the treatment of uncomplicated malaria.     However, it is critical to gather data on RBx 11160 when used as monotherapy in adult     patients suffering from acute uncomplicated P. falciparum malaria. In malaria-endemic     regions, an adult population is defined on the basis of immune status rather than the legal     age of consent. Thus, patients as young as 13 years of age can be enrolled provided consent     has been obtained from a legal guardian in accordance with local practices and regulations.     This study will be conducted in compliance with International Conference on Harmonization     (ICH) Good Clinical Practice (GCP).   "
192054|NCT00362063|"     The purpose of the proposed study is to investigate the effects of rhGH treatment on glucose,     protein and fat metabolism in GHD children. Specifically, the investigators will measure the     rates of glucose production, gluconeogenesis, glycogenolysis, insulin sensitivity and     glucagon response before and after treatment with rhGH. In addition, the investigators will     study changes in protein and fat metabolism pre and post rhGH therapy in children with GHD.     The findings in the GHD children will be compared to those of a control group of age and sex     matched healthy children.      Hypotheses: H1- The fraction of glucose derived from gluconeogenesis is decreased and that     from glycogenolysis is increased in the post-absorptive state in untreated GHD children when     compared to healthy children. H2- Treatment with rhGH will not change the overall glucose     turnover but will normalize the abnormal partitioning of gluconeogenesis and glycogenolysis     in GHD children. H3- GH replacement will reduce urea production and increase estimates of     protein synthesis, thus optimizing the availability of amino acids for growth. H4- Untreated     children with GHD after an overnight fast will have an increased glucagon challenge response     that will decrease after 8 weeks of treatment with rhGH.      Specific Aims: In healthy and newly diagnosed GHD children the investigators will: 1. Measure     the Glucose Production Rate (GPR) 2. Determine the fraction of glucose derived from     gluconeogenesis and glycogenolysis 3. Estimate insulin sensitivity 4. Measure proteolysis and     protein oxidation 5. Determine glucagon challenge response after an overnight fast. The     above-mentioned parameters will be re-evaluated in the children with GHD after 8 weeks of     rhGH therapy.   "
192055|NCT00362076|"     This study is concerned with psychological and physiological development in infants.     Specifically, researchers are interested in when and how babies are able to group similar     objects, like animals or vehicles, into the same category. This study will investigate     whether motion aids in the categorization process and allows for earlier demonstration of     this competency.      Previous studies have demonstrated that the ability to categorize stationary objects or     images of objects, is present by 6 months of age. This study is made up of three experiments     to test:        1. The infant's ability to categorize photographic stimuli.        2. The infant's ability to categorize moving stimuli.        3. The infant's ability to transfer knowledge from moving to photographic stimuli.      Initially, the abilities of 3- and 6-month-old infants will be compared. It is also possible     that 9-month-old infants will be tested. Data will consist of looking at time measures (level     of attention to displays) and heart rate. The ability of infants to transfer category     knowledge will support the view that motion is a source of information for object     categorization.   "
192056|NCT00362089|"     Pregnant and lactating women receive n-3 fatty acids starting from week 15 of gestation until     4 months post-partum (pp) in comparison to a control group, who only gets information about     adequately healthy nutrition during pregnancy and lactation.      The amount of fat in newborns is measured through skinfold thickness, ultrasound, and     magnetic resonance imaging (MRI).      It is hypothesised that a reduction in arachidonic acid intake and an increase of n-3 LC     PUFAs (long chain polyunsaturated fatty acids) via supplements containing docosahexaenoic     acid (DHA) and eicosapentaenoic acid (EPA) could lead to less expansive fat tissue     development in the first year of life.   "
192057|NCT00362102|"     To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects     with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease     to irinotecan-based chemotherapy and who have failed (progressive disease or intolerance)     previous oxaliplatin-based and fluoropyrimidine-based chemotherapies.   "
192058|NCT00362115|"     The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan     medoxomil, once daily (QD), in individuals with hypertension.   "
192059|NCT00362128|"     The Chinese population is currently the fastest growing ethnic group in New York City (NYC).     Research has shown that Chinese immigrants living in NYC have higher rates of cardiovascular     disease (CVD) than individuals in China. This study will evaluate the effect that     acculturation has on health habits and CVD risk factors in Chinese immigrants living in NYC.   "
192061|NCT00362167|"     This study offers evaluation and treatment for patients with a spectrum of acute and chronic     pain syndromes. The protocol is not designed to test new treatments; rather, patients will     receive current standard of care treatments. The purposes of the study are: 1) to allow     physicians in NIDCR's Pain and Neurosensory Mechanisms Branch to gain more knowledge about     treating acute and chronic pain and possibly identify new avenues of research in this area;     and 2) to establish a pool of patients who may be eligible for new studies as they are     developed. (Participants in this protocol will not be required to join a new study; the     decision will be voluntary.)      Patients 12 years of age and older with an acute or chronic pain syndrome may be eligible for     this study. Women of childbearing potential and women who are pregnant or breastfeeding will     not be enrolled in this study, drugs may have unknown or untoward side effects on the baby.      Participants will provide a medical history, as well as occupational and social information.     They will have a standard neurological examination, including a test of cognitive (thinking)     abilities, muscular function, reflexes and sensory examination. The latter involves testing     with a pin placed on the surface of the skin. Participants will also have routine blood tests     and will fill out questionnaires on their daily functioning and psychological well being.     Additional procedures may include magnetic resonance imaging (MRI) scans and possible     referral to a psychiatrist for evaluation of depression or emotional difficulties.      Participants will be treated according to their individual pain problem. Treatments may     include medicines, exercises, physical therapy, nerve blocks and dietary changes. Medicines     given in this study are commonly used by doctors to treat pain, but for many, there is little     research to back up their use. This study will provide information on the effectiveness of     these treatments. Participants will keep a daily log in which they rate their pain, record     any procedures they undergo outside the study, such as injections and exercises, and record     medication side effects.      Participation in the study will end based on the researcher's assessment of the patient's     response to treatment. The study doctor will provide the patient's referring doctor a report     of medications or other treatments used in the study. At the last visit, patients will fill     out the same questionnaires they filled out during the first visit.   "
192062|NCT00362180|"     This study will assess what, if any, effect that ISIS 301012 (mipomersen) has on liver     triglyceride content in multiple groups of subjects with varying degrees of risk for hepatic     steatosis. In order to enroll subject groups with varying degrees of risk, the study has     included multiple cohorts (Cohorts A-G). Additions and removal of cohorts has been     accomplished with protocol amendments.   "
192063|NCT00362193|"     This purpose of this study is to determine the optimal frequency of maintenance intervention     needed to prevent glycemic relapse.   "
192064|NCT00362206|"     Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both     hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary     mechanisms and can be coadministered to patients with mixed hyperlipidemia.The overall     objective of the study is to compare the efficacy and safety of combining fenofibrate and     simvastatin versus pravastatin monotherapy in patients with mixed hyperlipidemia at risk of     cardiovascular diseases.   "
192065|NCT00362219|"     The management of pain endured by patients after skin grafting is complex. Pain is the single     most distressing symptom but as it is difficult to manage, it is often under-treated. These     patients may experience pain from two types of wound: the original injury and from     skin-donor sites, areas of healthy skin from which skin is surgically removed and used to     cover the original injury. As the section of skin which is removed is standardized, the wound     created at the donor site is uniform and so provides a model of an acute wound.      Opioids (such as morphine) are the backbone of treating the moderate to severe pain     experienced by any patient. But due to their potentially severe side effects and that some     patients do not experience sufficient relief from the treatment, optimal treatment schedules     are still being sought after.      Topically applied morphine has provided effective and safe analgesia in several clinical     models. We, therefore, wish to apply this treatment modality onto skin-graft donor wounds. If     found to be effective this could be an appealing non-invasive method to treat the pain of     this type of wound.   "
192066|NCT00362232|"     The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is     safe and prevents blood clot which may form after a knee replacement operation.   "
192067|NCT00362245|"     The limited available data precludes establishing an antibiotic regimen in patients suffering     from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the     disposition of Amikacin administered intrathecally will enable to propose rational treatment     of these patients.   "
192068|NCT00362258|"     -  To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg          and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients.        -  To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline          (if any at the inclusion visit) in this population.        -  To demonstrate the safety of Irbesartan in this population.   "
192069|NCT00362271|"     The purpose of this clinical research study is to learn whether aripiprazole has effect on     the steady-state pharmacokinetics of venlafaxine in healthy subjects. The safety and     tolerability of aripiprazole and venlafaxine co-administration will also be studied.   "
192529|NCT00367263|"     This study is designed to evaluate a traditional paper symptom diary system versus the VOCEL     Mobile Diary. Subjects will be issued in a random order each system and asked their     preference at the end of their participation.   "
192071|NCT00362297|"     The purpose of the research study is to evaluate the effectiveness of high-dose acyclovir     compared to valacyclovir for reduction of asymptomatic genital shedding in persons with     genital herpes.      The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by     blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at     least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and     willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females     only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an     effective form of birth control.      Involvement in the study will last 15-weeks and you will be asked to visit the clinic every     2-weeks. At each visit, you will be given medication to take daily (either valacyclovir or     acyclovir; you will receive both medications at some point during this study). There will be     a total of 9 study visits and each visit will last approximately 30 minutes. We will ask that     you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday     during the study. Each daily home swab will take less than 3 minutes to perform.   "
192072|NCT00362310|"     Recent studies have described a reduced incidence or the regression of Kaposi's sarcoma (KS)     in HIV-infected patients treated with the highly active anti-retroviral therapy (HAART) that     contains at least one inhibitor of the HIV protease (HIV-PI) such as Indinavir. Experimental     studies have shown that part of the anti-KS actions of HIV-PI are not related to their     antiretroviral actions, but, at least in part, to their capability of blocking angiogenesis     and tumor growth.      This study will be conducted on HIV-negative (classical) KS patients to prove that Indinavir     has anti-angiogenic and anti-KS effects in humans independently of its antiretroviral     activity.   "
192073|NCT00362323|"     To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a     statin and receiving metformin, the superiority of a fixed combination of fenofibrate and     metformin vs metformin alone on TG and additionally, if the superiority on TG is established,     to demonstrate the superiority on HDL-C   "
192074|NCT00362336|"     The purpose of this study is to document the immunological response to the investigational     hexavalent vaccine at the 6, 10, and 14 weeks schedule      The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined     vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric     and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B     (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6,     10, and 14 weeks) with no HB vaccination at birth.      The secondary Objectives are:      To describe the safety in terms of any adverse events in the first 28 days after each     injection and any serious adverse events during the entire trial.      To describe Immunogenicity after the primary series and prior to and after a booster     vaccination.   "
192075|NCT00362349|"     Idiopathic Thrombocytopenic Purpura (ITP) is an autoimmune bleeding disorder characterised by     isolated low platelet counts. The aim of treating patients with ITP is to increase the     platelet concentration and reduce the risk of bleeding. A number of controlled multi-centre     studies have demonstrated that Intravenous Immunoglobulin (IVIg) therapy produces a rapid     rise in platelet counts within a 24 to 72 hour period. This study will evaluate the efficacy     and safety of Ig NextGen 10% in adult patients with ITP.   "
192076|NCT00362362|"     This study will collect blood samples from patients with primary lateral sclerosis (PLS) and     amyotrophic lateral sclerosis (ALS) to be used for research on genetic causes of motor neuron     diseases and other neurological disorders.      Patients 18 years of age and older with PLS or ALS may be eligible for this study. Candidates     are screened with a medical history, physical examination and diagnostic tests.      Participants provide a blood sample. The sample, along with masked (anonymous) medical and     family history information are sent to the NINDS Respository at the Coriell Cell Repositories     in Camden, NJ. This facility collects, stores and distributes medical research information     and cell cultures and DNA samples to researchers at hospitals, universities and commercial     organizations. The blood sample has an identification number that is unrelated to any     identifying information for the patient and cannot be tracked back to the patient.   "
192077|NCT00362375|"     The purpose of this program evaluation is to determine whether the Health Love Workshop, a     group-level HIV behavioral intervention, reduces HIV-related sex risk behaviors and increases     HIV protective behaviors of African American women and women of African descent. The intent     of this program is to support an evaluation of the efficacy of the intervention and to     provide feedback to the implementing organization to increase intervention effectiveness.   "
192078|NCT00362388|"     This study was designed to test the hypothesis that direct injection of bone-marrow cells in     the heart may increase the number of blood vessels, ameliorating the heart's performance, and     relieving patients from symptoms like angina and/or shortness of breath.   "
192079|NCT00362401|"     The purpose of this study is to compare the sound pressure levels (SPLs) from three of the     most frequently implanted mechanical heart valve prostheses, in order to determine whether     there was any significant difference between the intensities of the valve sounds   "
192080|NCT00362414|"     The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients     with acute ischemic stroke.   "
192081|NCT00362427|"     PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of     injections during the first 2 years of life while providing a complete course of immunization     against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium     diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3.      Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition     enhancement to the hepatitis B component when administered concomitantly with Prevnar®      Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered     concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for     routine infant vaccination in Canada.   "
192082|NCT00362440|"     The purpose of this study is to determine whether patients with HIV lipodystrophy (fat     wasting) benefit from taking the combination of two drugs, one insulin sensitizer (either     metformin or pioglitazone, both diabetes drugs) and leptin (a natural hormone produced by     your fat cells). Our hope is that they will improve sugar and fat metabolism and positively     affect the body fat changes you have noticed while taking HAART.   "
192530|NCT00367276|"     The purpose of this study is to evaluate the effects on the quality of life and BMI of new     contraceptives.   "
192083|NCT00362453|"     The purpose of this study was to compare the safety and effectiveness of Tai Chi with an     Attention Control intervention consisting of a stretching and wellness education program     involving 40 patients with osteoarthritis (OA) of the knee. We hypothesized that the     participants receiving Tai Chi would show greater improvement in knee pain, physical and     psychological functioning, and health-related quality of life than participants in the     Attention Control group, and that the benefit would be mediated by effects on muscle     function, musculoskeletal flexibility and mental health.   "
192084|NCT00362466|"     The purpose of this clinical research study is to compare the rate of complete cytogenetic     response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase     CML patients. The safety of this treatment will also be studied.   "
192085|NCT00362479|"     This is an open-label, single treatment study. All subjects will receive 6 months of oral     contraceptive therapy with DR-1021. Study participants will receive physical and     gynecological exams, including Pap smear. During the study, all participants will be required     to complete a diary.   "
192086|NCT00362492|"     The purpose of this study is to determine whether stopping Low Molecular Weight Heparin     (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators     select patients without proximal thromboembolism assessed by bilateral venous ultrasound     examination 7-10 days after surgery. the investigators hypothesis is that stopping     thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to     prevent post-surgery complications in this population.   "
192153|NCT00363389|"     To investigate if self-inserted vaginal misoprostol prior to outpatient hysteroscopy will     lead to satisfactory cervical ripening, compared to placebo.   "
192088|NCT00362518|"     The proposed study will examine the hypothesis that vitamin C and vitamin E given to type 2     diabetic individuals will provide effective anti-inflammatory, anti-thrombotic, and     anti-oxidative atherosclerotic protection when administered at the optimal dose as determined     by surrogate markers of inflammation, hypercoagulability, and oxidation.   "
192089|NCT00362531|"     Idiopathic membranous nephropathy (IMN) is one of the most common forms of nephrotic syndrome     (NS) in adults and is usually treated by corticosteroids in combination with cytotoxic drugs     especially cyclophosphamide or cyclosporine. Tacrolimus, a new immunosuppressive agent, was     proved to be effective in treating refractory NS. Whether it is effective in IMN has not been     reported. We therefore undertook a multi-center, controlled study to investigate the efficacy     and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients     with idiopathic membranous nephropathy and nephrotic syndrome.   "
192090|NCT00362544|"     This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome     loading dose regimen, in a weekly administration schedule, during the aplastic phase     following induction or consolidation chemotherapy for acute leukaemia, and during the initial     phase of allogeneic stem-cell transplant, which are both high risk periods as far as severe     fungal infections development is concerned.   "
192091|NCT00362557|"     Any patient already receiving a scheduled MR scan of the body for any clinical indication     will be eligible for this program. If patients agree to participate in this program, it would     require only a slightly longer examination time. This time would vary according to the body     area/organ being visualized but would not exceed 30 minutes over the length of the clinical     examination. Volunteers are eligible if they are willing to undergo an MR examination.      Patients would not be required to make any additional visits beyond their     clinically-indicated visits. The study duration would vary according to the body area/organ     visualized but would not exceed 30 minutes over the length of the clinical examination.     Volunteers would be required to keep one study appointment to include one MR imaging     examination.      There will be no interruption to the standard care given to patients who participate in this     trial since the clinical portion of their examination will be completed prior to the study     portion of the exam.   "
192092|NCT00362570|"     Rationale:      Standard therapy for anaplastic oligodendrogliomas and mixed oligoastrocytomas includes     radiation and chemotherapy. However, due to the potential long-term central nervous system     toxicity from radiation, researchers speculate that it may be better to reserve radiation     therapy for progressive disease. In addition, some patients with anaplastic oligodendroglioma     and mixed oligoastrocytoma have unusually chemosensitive tumors. Previous research indicates     that brain tumor patients with a deletion of the 1p chromosome have a higher response to the     chemotherapy drug temozolomide.   "
192093|NCT00362583|"     Primary objectives:        -  To confirm the efficacy of intranasal fentanyl titrated to doses 50, 100 or 200 µg for          treatment of breakthrough pain (BTP) in cancer patients        -  To establish long-term safety of treatment with intranasal fentanyl      Secondary objectives:      - To explore the relationship between dose of background opioid treatment and titrated     fentanyl dose   "
192094|NCT00362596|"     Herpes infection is an important co-factor in HIV transmission. A recent meta-analysis     demonstrated that HSV infection contributed to a 2-fold increased risk of HIV transmission.     Suppressive therapy with acyclovir has been a method proposed to reduce HIV transmission. We     are conducting a randomized controlled cross-over trial to evaluate the effect of acyclovir     suppressive therapy on HIV genital shedding in women co-infected with HIV-1 and Herpes     Simplex Virus Type-2 (HSV-2) in Thailand.   "
192095|NCT00362609|"     The purpose of this study is to determine whether or not consistent drug levels can be     achieved in infants with presumed Gastroesophageal Reflux Disease.   "
192096|NCT00362622|"     To determine the association between medical, demographic, socioeconomic, and therapeutic     differences on compliance with topical glaucoma therapy using the Travalert device.   "
192097|NCT00362635|"     The purpose of this study is to compare the efficacy and safety of 48-week treatment with     Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.   "
192098|NCT00362648|"     The purpose of the current study is to evaluate whether the vaccine is effective,     well-tolerated and immunogenic among infants in developing countries.   "
192099|NCT00362661|"     The aim of this prospective, double-blind, placebo-controlled, cross-over study is to     determine the therapeutic efficacy of low-dose cortisol for symptoms of chronic posttraumatic     stress disorder.   "
192101|NCT00362687|"     Many patients who already harbor drug-resistant HIV require interruption of HAART due to poor     compliance, poor quality of life, toxicity or development of resistance. In these patients     interruption of HAART has a negative impact on patient immune status due to the reemergence     of wild-type virus which is in general more pathogenic than HIV isolates containing     resistance mutations. There is a need for bridging antiretroviral regimens that might     prolong time off conventional HAART whilst waiting for a new regimen that is either fully     suppressive or less toxic or less demanding for the patient.   "
192102|NCT00362700|"     The purpose of this study is to determine the safety and antiviral activity of Clevudine,     when retreated to patients previously treated with Clevudine   "
192103|NCT00362713|"     The purpose of this study is to learn if ipilimumab can be given safely at two different     doses given to patients with urothelial cancer who are going to have surgery as part of their     treatment. The immunological effectiveness of ipilimumab will also be studied.   "
192104|NCT00362726|"     The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD     and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of     RGZ in healthy subjects.   "
192105|NCT00362739|"     This is a research study where researchers are collecting blood to evaluate the genetic     characteristics of individuals with chronic lung diseases, including asthma, chronic     obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, and lung     cancer.   "
192209|NCT00364130|"     The purpose of this 12-month double blind, placebo controlled randomized trial is to evaluate     the effects of daily treatments with low magnitude mechanical stimuli on bone in 160 children     with Crohn disease.   "
192210|NCT00364143|"     The purpose of this study is to determine whether IHL-305 (irinotecan liposome injection) is     safe and effective in the treatment of advanced solid tumors.   "
192106|NCT00362752|"     The hepatopulmonary syndrome (HPS)and pre-HPS is a disease seen in patients with chronic     liver disease, whereby patients develop dilations in the blood vessels of the lungs,     resulting in low oxygen levels and shortness of breath.      In this study, each HPS and pre-HPS subject will be treated with a commonly used antibiotic     called norfloxacin (approved for use in the treatment of gonorrhea, prostatitis and urinary     tract infections) for a 4-week period. In order to ensure that any observed improvement was     indeed due to norfloxacin, each subject will also be treated with a separate 4-week course of     an identical placebo. There will also be a 4 week wash-out period (no study     medication/placebo) between the 2 courses of treatment.      The primary aim of the study will be to measure improvements in oxygen levels while on     norfloxacin, although a number of secondary parameters will also be followed.   "
192107|NCT00362765|"     Double-blind, randomized placebo-controlled study in type 2 diabetes and dyslipidemic     patients.Patients will be randomized to one of four treatment arms for 16 weeks: placebo,     fenofibrate, metformin, or metformin and fenofibrate combination.   "
192108|NCT00362778|"     Hyperglycemia at admission has been associated with bad prognosis in patients with acute     myocardial infarction (AMI). The clinical benefit of intensive treatment with insulin has     been evaluated in diabetic patients admitted to intensive care units. The aim of our study     was to assess the short-term effects and the safety of strict glycemic control in subjects     with AMI and hyperglycemia without a previous history of diabetes.   "
192109|NCT00362791|"     The efficacy of counseling to prevent infection with the human immunodeficiency virus (HIV)     and other sexually transmitted diseases (STDs) has not been definitively shown. This     multi-center randomized controlled trial (Project RESPECT) sought to compare the effects of 2     interactive HIV/STD counseling interventions with didactic prevention messages typical of     current practice.      A total of 5758 STD clinic patients were enrolled from 5 public STD clinics (Baltimore, Md;     Denver, Colo; Long Beach, Calif; Newark, NJ; and San Francisco, Calif) between July 1993 and     September 1996. Eligible participants were heterosexual, HIV-negative patients aged 14 years     or older who came for full STD examinations. Using a block design, participating men and     women were randomzied separately to 1 of 3 individual face-to-face interventions. Arm 1     received enhanced counseling consisting of 4 interactive counseling sessions based on the     Theory of Reasoned Action and Health Belief Model. Arm 2 received brief counseling,     consisting of 2 interactive risk-reduction sessions based on CDC's client-centered counseling     model. Arms 3 and 4 each received 2 brief didactic messages about HIV/STD prevention messages     typical of current care at that time. Participants assigned to Arms 1, 2, and 3 were actively     followed up after enrollment with questionnaires at 3, 6, 9, and 12 months and STD laboratory     examinations and tests at 6 and 12 months. An intent-to-treat analysis was used to compare     interventions. Arm 4 participants were followed passively to determine potential effects of     active study follow-up.      The main outcome measures were self-reported condom use and new diagnoses of STDs (gonorrhea,     chlamydia, syphilis, HIV) defined by laboratory tests.      Results: At the 3- and 6-month follow-up visits, self-reported 100% condom use was higher     (P<.05) in both the enhanced counseling and brief counseling arms compared with participants     in the didactic messages arm. Through the 6-month interval, 30% fewer participants had new     STDs in both the enhanced counseling (7.2%; P = .002) and brief counseling (7.3%;P=.005) arms     compared with those in the didactic messages arm (10.4%). Through the 12-month study, 20%     fewer participants in each counseling intervention had new STDs compared with those in the     didactic messages arm (P = .008). Consistently at each of the 5 study sites, STD incidence     was lower in the counseling intervention arms than in the didactic messages intervention arm.     Reduction of STD was similar for men and women and greater for adolescents and persons with     an STD diagnosed at enrollment.      Subset analyses found that      Based on these results, we conclude that short counseling interventions using personalized     risk reduction plans can increase condom use and prevent new STDs. Effective counseling can     be conducted even in busy public clinics.   "
192110|NCT00362804|"     Purpose of Study:      A) To improve outcome in large population of antipsychotic patients with schizophrenia or     schizoaffective who are only partial responders B) To increase understanding of pharmacology     and mechanisms of action underlying antipsychotic effect      Hypothesis/Objectives of the Study:      Tetrabenazine, through its pre-synaptic action, should augment the post-synaptic effects of     an antipsychotic.      Background and Rationale for the study:      Preliminary evidence that other amine-depleting agents e.g., reserpine, can induce such an     effect   "
192111|NCT00362817|"     Purpose: The primary objective of this study is to determine if chemotherapy with carboplatin     and temozolomide significantly affects the response rates, or size of disease, in patients     with brain metastases, originating from cancer in other parts of the body, compared to     patients who have already been treated with radiation. Survival, causes of death, recurrence     of disease in the central nervous system, toxicity, and quality of life will all be measured     as secondary objective in this study.   "
192112|NCT00362830|"     The purpose of the study is to test how vinflunine interacts with ixabepilone in the human     body.   "
192113|NCT00362843|"     Biosynthesis of proteins is essential for growth and continued maintenance of the entire     neuron including axons, dendrites, and synaptic terminals, and it is clearly one of the     important biochemical processes underlying adaptive changes in the nervous system. Studies in     experimental animals with the quantitative autoradiographic L [1 (14)C]leucine method have     demonstrated a number of the physiological and pathological conditions in which changes in     regional rates of cerebral protein synthesis (rCPS) occur.      We have recently developed the first fully quantitative method for determining rCPS with     positron emission tomography (PET). The PET method was adapted from the autoradiographic L [1     (14)C]leucine method; it uses L [1 (11)C]leucine as the PET tracer, dynamic scanning, and a     kinetic modeling approach for quantification. This method was validated in nonhuman primates     by comparison of PET measurements with those based on established biochemical and     autoradiographic techniques.      The objective of the present study is to examine the degree to which changes in rCPS in human     subjects can be quantified with the L [1 (11)C]leucine PET method. We propose three studies     to be carried out sequentially. In Part I we will establish the L-[1-(11)C]leucine PET method     in human subjects. In Part II we will measure rCPS in normal control subjects in two states:     awake and under deep sedation/general anesthesia with propofol. A difference in rCPS between     these two states may indicate that we can detect activity-dependent protein synthesis with     the PET method. In Part III we will study subjects with fragile X syndrome. This patient     group was chosen since the affected gene in fragile X syndrome codes for a protein that is     thought to be a negative regulator of message translation. Thus an effect on protein     synthesis may be very close to the underlying genetic abnormality in fragile X syndrome.     Regionally selective increases in rCPS have been found in studies in a mouse model of this     disease.      The present study will establish the sensitivity of the L [1 (11)C]leucine PET method to     detect changes in rCPS in human subjects. A quantitative and sensitive method to measure rCPS     with PET will augment the tools available for investigating the brain and its regional     adaptive responses. Ultimately the method may have widespread applications, not only for the     study of normal development and plasticity but also in clinical medicine, e.g., in the     investigation of disorders of brain development, recovery from brain injury, and     neurodegenerative diseases.      SPECIFIC AIMS        1. <TAB>Establish the L-[1-(11)C]leucine PET method for measurement of rCPS in human          subjects. Evaluate the optimal scan time and the variability of the measurement in an          individual.        2. <TAB>Determine the effect of deep sedation with propofol on rCPS in normal human          subjects. We will use the [1-(11)C]leucine PET method to evaluate lambda, i.e., the          fraction of the precursor pool for protein synthesis that is derived from arterial          plasma, and rCPS in the same subjects under awake and deep sedation conditions.           I)<TAB>Hypothesis 1a. Deep sedation with propofol has effects on rCPS.           II)<TAB>Hypothesis 1b. Deep sedation with propofol has effects on values of lambda.        3. <TAB>Assess the sensitivity of the [1-(11)C]leucine PET method to detect differences in          rCPS in subjects with fragile X syndrome.      I)<TAB>Hypothesis 3a. There are regionally selective changes in rCPS in subjects with fragile     X syndrome compared with age-matched healthy controls. Regions affected include hippocampus,     thalamus, hypothalamus, amygdala, and frontal and parietal cortex.      II)<TAB>Hypothesis 3b. In centrum semiovale, cerebellum, striatum and occipital and temporal     cortex rCPS are unchanged in subjects with fragile X syndrome compared with age-matched     healthy controls.      III)<TAB>Hypothesis 3c. Values of lambda in the brain as a whole and in the regions examined     are unchanged in subjects with fragile X syndrome compared with age-matched healthy controls.      IV) Hypothesis 3d. The average rate of protein synthesis in the brain as a whole is unchanged     in subjects with fragile X syndrome compared with age-matched healthy controls.   "
192114|NCT00362856|"     There are no therapeutic products on the market for celiac disease today. Current treatment     is limited to gluten free foods and a gluten-free diet.      The main purpose of this study is to test how safe, efficacious and tolerable the study drug     AT1001 is in subjects with diagnosed celiac disease.      A second purpose is to study how your body responds to the drug when you ingest gluten. This     response is determined by testing your urine, and by capturing your daily and weekly     gastrointestinal symptoms associated with celiac disease.   "
192144|NCT00363272|"     This phase I trial is studying the side effects and best dose of ispinesib in treating young     patients with relapsed or refractory solid tumors or lymphoma. Drugs used in chemotherapy,     such as ispinesib, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing   "
192115|NCT00362869|"     Enteroaggregative E. coli (EAEC) is a bacterium that can cause diarrhea. The purposes of this     study are to: determine how much EAEC is needed to cause diarrhea in a healthy person,     determine if a genetic factor is important in causing diarrhea, and to see how the body's     defenses control EAEC. Participants include 25 healthy adults, ages 18-40. Volunteers will be     assigned to 1 of 4 dose levels in groups of 5 volunteers each. One volunteer in each group     will receive a sodium bicarbonate placebo solution. Volunteers will be admitted to the     University Clinical Research Unit for up to 8 days. Volunteers will receive therapy with     levofloxacin to treat the infection either once they develop diarrhea or at Day 5 if they     remain asymptomatic. Study procedures will include saliva, blood, and fecal sample     collection. An optional study procedure will include an intestinal biopsy. Participants will     be involved in study related procedures for up to 223 days.   "
192116|NCT00362882|"     This trial is studying two different schedules of docetaxel and bortezomib to compare how     well they work in treating patients with progressive or recurrent non-small cell lung cancer.     Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     docetaxel together with bortezomib may kill more tumor cells   "
192117|NCT00362895|"     The purpose of the study is to determine the amount of study medication that moves from the     front of the eye into the fluid at the front of the inside of the eye.   "
192118|NCT00362908|"     The metabolic syndrome consists of five concurrent conditions which increase risk of heart     disease, stroke, and diabetes. Persons with the metabolic syndrome usually have high     triglyceride and low HDL levels and are overweight. Low fat, high carbohydrate diets may not     provide the same cholesterol-lowering benefits to obese individuals as they do to non-obese     individuals. The purpose of this study is to compare the effects of a low fat, high     carbohydrate diet versus a moderate fat, moderate carbohydrate diet on the heart, blood     vessels, and cholesterol levels in individuals with metabolic syndrome.   "
192119|NCT00362921|"     RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and O6-benzylguanine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving Gliadel wafer together with     O6-benzylguanine works in treating patients with recurrent glioblastoma multiforme.   "
192120|NCT00362934|"     Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both     hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary     mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall     objective of the study is to compare the efficacy and safety of combining fenofibrate and     simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of     cardiovascular diseases.   "
192121|NCT00362947|"     The optimal treatment of superficial venous thrombosis (SVT) is still uncertain. Though low     molecular weight heparin (LMWH) is considered the treatment of choice, studies conducted so     far do not give clear indications of the optimal dose and duration of treatment. This study     aims to evaluate whether an intermediate therapeutic dose of LMWH (parnaparin) is more     effective than a prophylactic dose and also to assess whether 10 rather than 30 days are     sufficient for treatment.   "
192122|NCT00362960|"     Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function     and inflammatory markers in patients with diabetic nephropathy   "
192123|NCT00362973|"     RATIONALE: Diagnostic procedures, such as PET scans, may help in learning how well hormone     therapy and trastuzumab work to kill breast cancer cells and allow doctors to plan better     treatment.      PURPOSE: This clinical trial is studying how well PET scans work in assessing response to     treatment in patients receiving hormone therapy or trastuzumab for breast cancer.   "
192124|NCT00362986|"     RATIONALE: Topical sunscreen may be effective in preventing skin rash caused by treatment     with drugs such as erlotinib or cetuximab. It is not yet known whether topical sunscreen is     more effective than a placebo in preventing skin rash in patients receiving drugs such as     erlotinib or cetuximab for cancer.      PURPOSE: This randomized phase III trial is studying topical sunscreen to see how well it     works compared with a placebo in preventing skin rash in patients receiving drugs such as     erlotinib or cetuximab for cancer.   "
192125|NCT00362999|"     The hypothesis to be proven is that histamine iontophoresis with measurement of microvascular     blood flow by laser Doppler flowmetry can be used as a reliable marker to characterize the     normal microvascular cutaneous response to histamine.   "
192126|NCT00363012|"     RATIONALE: Studying the immune response to a vaccine made from HER2/neu protein may help     doctors plan better treatment for patients with breast cancer that overexpresses HER2.      PURPOSE: This clinical trial is studying the immune response in patients who have undergone     vaccine therapy for stage III or stage IV breast cancer that overexpresses HER2.   "
192127|NCT00363025|"     In this ALFA-9803 trial in AML patients aged 65 years or more, we randomly compared     idarubicin or daunorubicin throughout the study (first randomization) and two different     post-remission strategies (second randomization): one single intensive consolidation course     similar to induction versus six ambulatory cycles with one dose of idarubicin/daunorubicin     (day 1) and 2x60 mg/m2/d cytarabine SC (day 1 to 5) delivered in out-patients on a monthly     basis. Primary endpoint was 2-year overall survival (OS). Study hypotheses were equivalence     for the idarubicin/daunorubicin comparison and a 15% difference in 2-year OS for the     post-remission therapy comparison.   "
192128|NCT00363038|"     The objective of this study is to assess the comparative utility of topical formulations in     hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm     diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using     a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K,     1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per     subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist     rated bruises in standardized photographs immediately after bruise creation and at week 2.   "
192174|NCT00363675|"     This study is designed to see if some tests of hand movement, strength, and function are     valid for children with burns.   "
192129|NCT00363051|"     The purpose of this study was to assess the efficacy and safety of everolimus in the     treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic     chemotherapy. All patients were treated with everolimus until either tumor progression was     documented using a standard criteria that measures tumor size called Response Evaluation     Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the     patient or investigator requested discontinuation of treatment.   "
192130|NCT00363077|"     The purpose of this study is to evaluate the immunogenicity and the safety of the candidate     vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above   "
192131|NCT00363090|"     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from growing.     Giving alemtuzumab together with combination chemotherapy may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab when     given together with combination chemotherapy and to see how well they work in treating     patients with newly diagnosed aggressive stage II, stage III, or stage IV T-cell     non-Hodgkin's lymphoma.   "
192132|NCT00363116|"     The purpose of the study is to determine the safety and efficacy of two dosing regimens of     daclizumab in simultaneous kidney/pancreas transplant recipients.   "
192133|NCT00363129|"     RATIONALE: Vitamin E may prevent peripheral neuropathy caused by chemotherapy in patients     with cancer. It is not yet known whether vitamin E is more effective than a placebo in     preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy     for cancer.      PURPOSE: This randomized phase III trial is studying vitamin E to see how well it works     compared with placebo in preventing peripheral neuropathy caused by chemotherapy in patients     receiving chemotherapy for cancer.   "
192134|NCT00363142|"     This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted     fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen     administered either twice-daily or once-daily.   "
192135|NCT00363155|"     The purpose of this trial is to determine the safety, tolerability and effectiveness of     KRN7000 for chronic hepatitis B infection.   "
192136|NCT00363168|"     This research is being done to look at the effects of an experimental drug, ranibizumab, on a     condition called predominantly hemorrhagic subfoveal choroidal neovascularization (CNV) due     to wet age-related macular degeneration.      A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal     neovascular lesion is occupied by blood under the retina. We want to find out if injections     of ranibizumab into the eye will help patients with this condition.   "
192137|NCT00363181|"     Medications like olanzapine have been associated with the development of weight gain and     diabetes in some patients. It is not known if the increased risk of developing diabetes is a     direct effect on insulin or simply related to weight gain.      We hope to learn in this study whether or not olanzapine directly slows down insulin     secretion from the pancreas, thereby increasing the risk of developing diabetes.   "
192138|NCT00363194|"     This is two-part study (Part I/Part II). Part I is designed to determine the effect of a low     and high fat meal on the pharmacokinetics of single dose pazopanib (GW572016). Part II is     designed to allow patients continued access to study drug in a multiple dosing regimen.     Patients who are receiving clinical benefit on that regimen will go into the long term     rollover study VEG105430 provided they are stable for 8 weeks.   "
192139|NCT00363207|"     In children, behavior management is critical to the success of pediatric dental procedures.     Most of the studies on local anesthesia performed in children deal with the question how to     avoid or minimize pain during injection. Due to the sensation of numbness children scratch     the soft tissues and bite lips and tongue. In many cases, this may be kept in children's     memory as a painful experience and may affect their behavior in the following visit. The     purpose of this study is to evaluate children's reactions to the administration of local     anesthetic injection in the mandible (mandibular block) and in the maxilla (supraperiosteal     infiltration), and to assess their behavior in the following visit related to each type of     injection.   "
192140|NCT00363220|"     The purpose of this study is to review patients with E. coli infections at the University of     Pittsburgh Medical Center (UPMC) from September 1, 2006 to August 31, 2007 to determine if     these infections have arisen in the community rather than in hospitals or nursing homes. The     occurrence of such resistant isolates could be devastating if they were associated with     bloodstream infection, such as sometimes accompanies a urinary tract infection, since     antibiotic resistant E. coli is not suspected in isolates coming from the community.     Therefore, the aims of this study are to:        1. Review whether extended-spectrum beta-lactamase (ESBL)-producing organisms (E. coli,          Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated, or          community-associated.        2. Investigate the prevalence of ESBL-positive E. coli in foodstuffs (beef, poultry,          turkey, and pork), as a potential source for ESBL producers in the community.        3. Compare the clonal relationship of the genome and resistance plasmids carried by the          ESBL-producing isolates (healthcare-associated, community-associated, and of animal          origin) and study the associations of ESBL-mediated resistance with resistance to other          classes of antimicrobials.   "
192141|NCT00363233|"     The purpose of the study is to improving the lipid profile and glucose control in type 2     diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans     supplement will improve the cholesterol profile and glucose control in type 2 diabetic     patients.   "
192142|NCT00363246|"     The purpose of this study is to find out about the risk factors for wheelchair-related falls     among elderly veterans, and to find out about the costs and consequences of those falls.   "
192143|NCT00363259|"     The purpose of this study is to compare the sustained virological response rate at 24 weeks     after the end of experimental treatment (induction and 72 weeks) to that of standard 48 weeks     treatment with PEG-inteferon alfa-2b and ribavirin in patients with chronic hepatitis C     previous unresponsive to interferon alfa monotherapy or interferon alfa/ribavirin combination     therapy.   "
192145|NCT00363285|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as     cyproterone acetate may stop the adrenal glands from making androgens. Sometimes the tumor     may not need treatment until it progresses. In this case, observation may be sufficient. It     is not yet known whether giving cyproterone acetate continuously is more effective than     giving cyproterone acetate after tumor progression in treating prostate cancer.      PURPOSE: This randomized phase III trial is studying cyproterone acetate to compare how well     it works when given continuously or after tumor progression in treating patients with newly     diagnosed stage III or stage IV prostate cancer.   "
192146|NCT00363298|"     The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective     when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and that tolerance     (loss of therapeutic effect) to the medication will not develop over a period of several     weeks.   "
192147|NCT00363311|"     The purpose of this study is to examine the effect of dutasteride on the inhibition of     low-risk, localized prostate cancer progression in men who would otherwise receive no active     therapy (expectant management).   "
192148|NCT00363324|"     This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in     patients with a acute myocardial infarction.   "
192149|NCT00363337|"     The specific aim of this study is to obtain preliminary evidence of the acute effectiveness     and tolerability of aripiprazole in the treatment of bipolar depression.   "
192150|NCT00363350|"     This study is an evaluation of the effect of rituximab compared to placebo in combination     with steroids on salivary flow and serological and clinical parameters in patients with     primary SS.   "
192154|NCT00363402|"     Cystic fibrosis (CF) is an autosomal recessive disorder caused by mutations in the CF     trans-membrane conductance regulator (CFTR) protein. CF is the most common inherited disease     of Caucasians, with a carrier frequency of 1 in 25-30 individuals. Even with the impressive     advances achieved in the understanding of the molecular basis and physiopathology of CF, it     remains a life-threatening disorder that causes severe lung damage and nutritional     deficiencies. It is generally accepted that early therapy could delay the progression of lung     disease. A number of non-invasive methods are available to monitor disease activity in CF     patients; however none of the currently used tools are able to monitor real-time events.     Recently high resolution computed tomography (HRCT) has been used to monitor changes in lung     structure. However, HRCT does not allow differentiating between acute and chronic lesions.     Positron emission tomography (PET) with 18fluoro-deoxy-glucose (FDG) has already been used in     a variety of settings to visualize inflammation or infection. FDG-PET imaging appears to be a     promising new tool to quantify inflammation as it can detect clinically relevant changes even     when no changes or minimal ones are detected by morphologic imaging. PET/CT may consequently     be used to evaluate the severity of lung inflammation/infection in CF patients, and therefore     the aim of this study is to evaluate the use of PET/CT for the assessment of the severity of     lung inflammation/ infection in CF patients.   "
192155|NCT00363415|"     This study is a Phase 3, global, multi-center, open-label study of patients with     extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to     receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated     that pemetrexed plus carboplatin will offer similar survival benefits as compared to     etoposide plus carboplatin.   "
192156|NCT00363428|"     RATIONALE: Exercise may help improve lung function and lessen complications of surgery in     patients with chronic obstructive pulmonary disease who are undergoing surgery for lung     cancer. It is not yet known whether lung rehabilitation is more effective than standard     therapy in improving lung function in patients with chronic obstructive pulmonary disease who     are undergoing surgery for lung cancer.      PURPOSE: This randomized clinical trial is studying lung rehabilitation to see how well it     works compared to standard therapy in treating patients with chronic obstructive pulmonary     disease who are undergoing surgery for lung cancer.   "
192157|NCT00363441|"     This is a randomized study of conventional 3d radiation versus intensity-modulated radiation     in squamous cell cancer of the head and neck.   "
192158|NCT00363454|"     Phase I dose escalation study of Triciribine Phosphate Monohydrate (TCN-PM) in patients with     metastatic cancer whose tumors must be shown to be p-Akt positive. Study patients will be     recruited from a Moffitt Cancer Center companion study (MCC-14474) Immunohistochemical study     of phosphorylated Akt in solid malignancies.      Each treatment cycle will consist of four weeks with TCN-PM being administered weekly (days     1, 8 and 15 every 28 days). Labs, vital signs (BP, HR, Resp Rate, Temp), and hematology and     serum chemistry profile are to be performed weekly and/or prior to each treatment dose. Body     Surface Area (BSA) should be calculated approximately every 8 weeks. Imaging studies (CT/MRI     of chest, abdomen, and pelvis) and tumor response assessments will be performed every eight     weeks or more frequently if indicated. Unless unacceptable toxicity occurs, the duration of     treatment will be based on tumor reassessment.   "
192159|NCT00363467|"     During the pre-transplantation phase (following completion of consolidation chemotherapy),     patients will begin to receive G-CSF at 10 mcg/kg twice daily; leukapheresis will also be     given until a target goal for recipient body weight is obtained, or up to a maximum of 5     days. Conditioning/Preparative therapy will follow PBSC collection for up to 30 days with     Busulfan IV daily x 4 days; subsequent doses will be adjusted based on pharmacokinetic     (plasma level)monitoring. Following 1 day of rest, stem cell reinfusion will begin with     supportive care. During follow-up, patients will be monitored out to 730 days.   "
192175|NCT00363688|"     The purpose of this study is to examine whether oral challenge with penicillin for patients     with a known history of non-life threatening allergic reaction to penicillin is     well-tolerated irrespective of skin-testing results   "
192160|NCT00363480|"     The majority of asthma patients are not well controlled, despite the availability of asthma     medication that could effectively treat the disease. In this study uncontrolled patients who     are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide     (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. The asthma control test     (ACT) will be used to detect differences in the level of asthma control during treatment. The     study aims to show a correlation between improvements of ACT und the level of asthma control     which will be reached by the patients.      The aim of the study is to show that most of symptomatic asthma patients can reach 'well     controlled asthma' with SFC. We get information about ACT in daily practice and physicians     are trained to use the asthma control test as a screening tool and for follow up of asthma     management. Correlations are expected between the improvements in ACT, Quality of Life and     asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.   "
192161|NCT00363506|"     The purpose of this study is to evaluate the use of nutritional supplementation and dietary     management for the reduction in frequency, duration, and intensity of migraine headache pain.   "
192162|NCT00363519|"     The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in     patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise     therapy and glimepiride as monotherapy   "
192163|NCT00363532|"     In patients known with migraine without aura a migraine headache or migraine like headache     will be induced by infusion of calcitonin gene related peptide (CGRP). The patients will then     be stimulated with noxious heat via a thermode placed at the forehead. At the same time the     Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic     resonance imaging (fMRI), to estimate the central-nervous pain response. The regions of     interest (ROI) will be thalamic region and medulla oblongata.      Then the patients will be given pain relif in form of injection of sumatriptan and the effect     of this will also be registered via measuring the BOLD response at the RIO's previously     defined. A 3-Tesla MRI scanner will be used in this trail.      This study will give us key knowledge of the trigeminal pain pathway and the central     processing i.e sensitization during a migraine attach.   "
192164|NCT00363545|"     This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the     liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of     GSK Biologicals' HRV vaccine   "
192165|NCT00363558|"     Skin graft fixation is essential for the success of its survival. There are several common     methods for skin graft fixation including sutures, skin staples and glue. The study objective     is to compare between skin graft fixation with staples and glue in burn patients. The study     is retrospective. It Includes 44 patients that were hospitalized in the burn unit, Rabin     Medical Center, Israel with 2nd and 3rd degree burns, total body surface area 1-50% during     1/2002-5/2003.All patients were operated for debridement and skin grafting. In 29 patients     the skin graft was fixated with staples and in 15 with cyanoacrylate glue (histoacryl). The     parameters that will be compared are skin graft take, hospitalization length and local     infection.   "
192166|NCT00363571|"     After infusion / injection of Glyceryl trinitrate and Diamox it is wished to study the effect     of drugs on the cerebral haemodynamics such as Cerebral blod flow and cerebral blod volume.   "
192167|NCT00363584|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving capecitabine after surgery may kill any tumor cells that remain after surgery.     Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this     case, observation may be sufficient. It is not yet known whether capecitabine is more     effective than observation in treating biliary tract cancer.      PURPOSE: This randomized phase III trial is studying capecitabine to see how well it works     compared with observation in treating patients with biliary tract cancer.   "
192168|NCT00363597|"     The main purpose of this study is to evaluate whether intestinal permeability and/or serum     zonulin concentration is increased in children/adolescents with functional dyspepsia (FD).     The study will also explore the relationships between intestinal permeability, mucosal     inflammation and anxiety in FD patients.   "
192169|NCT00363610|"     This study will research the side effects of pegaspargase (pronounced peg-as-par-gase); its     brand name is ONCASPAR® when it is used with another FDA-approved cancer treatment     (chemotherapy) drug called gemcitabine HCl (pronounced gem-site-a-bean; its brand name is     GEMZAR®.   "
192170|NCT00363623|"     The primary purpose of this study is to investigate the performance of contact lens     maintenance systems when used with silicone hydrogel contact lenses during daily wear over a     period of 1 month.   "
192171|NCT00363636|"     This is a Phase III, multicenter, global, clinical study of an investigational drug called     galiximab in combination with an approved drug called rituximab in subjects with follicular     NHL.      The purpose of the study is to compare the clinical benefit of galiximab when given in     combination with rituximab as compared with rituximab alone (given with placebo) in subjects     with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be     evaluated.   "
192172|NCT00363649|"     RATIONALE: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer     cells. GM-CSF may help cells that are involved in the body's immune response work better.     Vaccines made from a person's cancer cells may help the body build an effective immune     response to kill cancer cells.      PURPOSE: This randomized phase II trial is studying tyrosine kinase inhibitors, interferon     alfa, and GM-CSF to see how well they work compared to tyrosine kinase inhibitors and vaccine     therapy in treating patients with chronic phase chronic myelogenous leukemia.   "
192173|NCT00363662|"     The overall aim of this project is to prospectively determine whether MRI can improve the     conventional neuroradiological evaluation (CT with or without cerebral angiography) of     patients with a spontaneous ICH or IVH. The study design will also allow us to identify the     added benefit of specific MR sequences and repeat MRI in the chronic stage, thereby allowing     us to prospectively determine their value in a consecutive series of patients. This     information should have a major impact on the management of these patients by providing data     on the diagnostic yield of routine MRI in patients presenting with a wide variety of causes     for ICH or IVH. These data will help guide the diagnostic evaluation and the management of     brain hemorrhage patients in the future.   "
192177|NCT00363714|"     The purpose of this study will be to assess the safety and tolerability and dose-limiting     toxicity of a single intravitreal injection of Sirna-027 (AGN211745) and to assess the     anatomical changes in the retina, changes in CNV, and changes in visual acuity. Escalation to     the next dose cohort will be completed following minimum of 2 weeks follow-up. Patients will     be monitored intensively for three months, and then followed-up for safety up to 24 months     post-injection.   "
192178|NCT00363727|"     This study evaluates how effective a new formulation of a marketed drug is in increasing the     time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with     Parkinson's Disease who have been taking levodopa for less than 2 years.   "
192179|NCT00363740|"     This study was designed to compare the efficacy and safety of an investigational nasal spray     compared with placebo nasal spray and commonly used drug in the treatment of seasonal     allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that     occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis     (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses,     and weeds. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and     pruritic, watery, red eyes.   "
192180|NCT00363753|"     Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient     ischemic attack.   "
192181|NCT00363766|"     The primary objective is to estimate the time to progressive disease for patients who receive     LY573636 after two previous treatments for metastatic non-small cell lung cancer. Patients     will receive an intravenous infusion of study drug once every 21 days. CT-scans will be done     before the first dose and then after every other treatment.   "
192222|NCT00364312|"     Lifestyle interventions have been shown to reduce heart disease risk and improve blood sugar     control in clinical trials. This project will investigate whether those lifestyle     interventions can be implemented long-term, in usual practice settings, by using dietitian     case managers to coordinate lifestyle change in cooperation with fitness instructors and     primary care clinicians.   "
192223|NCT00364325|"     The purpose of this study is to collect data on the medical management of patients presenting     to the Emergency Department who are treated for Acute Decompensated Heart Failure (ADHF) in a     hospital setting that has incorporated a disease management program for heart failure.   "
192182|NCT00363779|"     Background:        -  Large granular lymphocyte (LGL) leukemia is a low-grade non-Hodgkin's lymphoma.        -  LGL is associated with low numbers of white blood cells (leading to recurring          infections), red blood cells (causing anemia) and platelets (causing abnormal bleeding).        -  Cyclosporine (CSA) is an immunosuppressive drug that improves low blood cell counts in          about 50 percent of patients with LGL leukemia.      Objectives:        -  To identify what factors determine why cyclosporine works in some patients and not in          others.        -  To identify what causes low blood counts in LGL leukemia.      Eligibility: Patients 18 years of age and older with LGL leukemia.      Design:        -  Patients have a medical history, physical examination blood tests, bone marrow biopsy          and x-ray studies, including chest x-rays and computed tomography (CT) scans of the          chest, abdomen and pelvis. Patients with an easily accessible enlarged lymph node have a          node biopsy (removal of a small piece of tissue for microscopic examination).        -  Patients take cyclosporine twice a day by mouth. Blood samples are taken at least weekly          to adjust the cyclosporine dosing to maintain therapeutic serum levels.        -  Patients undergo apheresis (collection of white blood cells) at a number of different          time points in the study (maximum 6 times) to look at the differences in the leukemia          cells before and during treatment with cyclosporine. For apheresis, blood is withdrawn          through a needle in an arm vein and directed through a catheter (plastic tube) into a          machine that separates it into its components. The white cells are extracted and the          rest of the blood is returned through the same needle or through a second needle in the          other arm.   "
192183|NCT00363792|"     In healthy subjects different cerebral haemodynamic values wished to be determined after     infusion of the NO donor Glyceryl trinitrate (GTN) and Diamox. The different values we wish     to determine are:        -  Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.        -  Changes in the diameter of a. cerebri media.        -  Changes in the regional and global cerebral blodd flow (CBF) with the help of the          arterial Spin labeling (ASL) method.   "
192184|NCT00363805|"     RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming,     growing, or coming back. The use of green tea or polyphenon E may prevent cancer from forming     in former smokers with chronic obstructive pulmonary disease.      PURPOSE: This randomized phase II trial is studying how well green tea or polyphenon E work     in preventing lung cancer in former smokers with chronic obstructive pulmonary disease.   "
192185|NCT00363818|"     The proposed study is a prospective one, and will be held on consecutive individuals     undergoing the non-invasive brachial artery flow-mediated dilation (FMD) ultrasound for     endothelial function at the endothelial function laboratory of the Sheba Medical Center. The     study group will be divided into healthy subjects group and coronary artery disease (CAD)     patients group, both of which will be analyzed in respect to age, cardiovascular risk factors     and the results of the platelet and endothelial functions tests. The association between     platelet and endothelial functions will be then assessed in the healthy subjects group and in     the CAD patients group.   "
192186|NCT00363831|"     Primary:        -  To evaluate the efficacy of capecitabine in combination with oxaliplatin (XELOX) in          terms of overall response rate (based on RECIST criteria) in patients with metastatic          NPC without prior chemotherapy for relapse.      Secondary:        -  To evaluate the efficacy profile of oxaliplatin (XELOX) in patients with metastatic NPC          in terms of time to progression of disease, survival time, duration of response and          complete response rate.        -  To study the safety and tolerability of the regimen in patients with metastatic NPC.   "
192187|NCT00363844|"     Determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes     mellitus who have inadequate glycemic control on diet/exercise therapy   "
192188|NCT00363857|"     A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and     placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome     (RLS) in the United States.   "
192189|NCT00363870|"     The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza     vaccine (Fluarix™) administered intramuscularly in adults.   "
192190|NCT00363883|"     Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. This phase II trial is studying how well vorinostat works in treating patients with     locally recurrent or metastatic cancer of the urothelium.   "
192191|NCT00363896|"     To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with     moderate to severe COPD during one year of treatment.   "
200677|NCT00468494|"     Surgery performed during general anesthesia induces a stress effect on the body. Our plan is     to identify population at risk of hyperglycemia during perioperative period.   "
192192|NCT00363909|"     RATIONALE: Citalopram may help relieve hot flashes in women who had or have not had breast     cancer. It is not yet known which dose of citalopram is more effective in treating hot     flashes in postmenopausal women.      PURPOSE: This randomized phase III trial is studying three different doses of citalopram to     compare how well they work in treating postmenopausal women with hot flashes.   "
192193|NCT00363922|"     The purpose of this study is to compare different types of rehabilitation after coronary     bypass surgery. The investigators wish to compare rehabilitation in an institution for four     weeks with a home based rehabilitation. They also wish to compare rehabilitation in an     institution for four weeks with a rehabilitation program were the patients live at home but     visit the hospital twice a week for twelve week. The investigators will measure the patients'     physical capacity by measuring their maximal oxygen consumption. The investigators will also     analyze their blood and their endothelian function (how well their arteries dilate).   "
192194|NCT00363935|"     After obtaining informed consent,80 morbidly obese ASA II-III patients undergoing     laparoscopic bariatric surgery procedures would be randomly assigned to one of four study     groups at UTSWMC at Dallas.Hemodynamic paarameters, recovery times, postoperative pain     scores, the need for rescue analgesics and side effects will be recorded.The purpose of this     study is to determine the optimal linfusion rate of dexmedetomidine for maintaining     cardiovscular stability during general anesthesia.   "
192195|NCT00363948|"     The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in     patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise     therapy and metformin as monotherapy   "
192196|NCT00363961|"     There is a rising incidence of kidney failure in the US, with poor outcomes and high cost.     End-stage renal disease (ESRD) affects almost 375,000 individuals in the US at a cost of more     than $14 billion per year. Despite advances in dialysis and transplantation therapies, kidney     failure leads to poor outcomes, poor prognosis and high health care costs. Malnutrition and     the underlying systemic inflammatory response developed during the course of chronic kidney     disease, worsen during ESRD, and lead to adverse outcomes, increased morbidity and mortality.     Muscle wasting, impaired functional capacity and poor quality of life are the most important     factors associated with malnutrition and inflammation in renal failure. We have shown in pre     dialysis patients with moderate chronic renal insufficiency that the anabolic effects of     resistance exercise training result in significant improvements in protein utilization,     nutritional status and functional capacity even in the context of anorexia and prescribed low     protein diets. Therefore, we propose to develop, test and implement a progressive resistance     exercise routine for ESRD patients during the hemodialysis session. By implementing such     intervention, we hope to offer a therapeutic strategy that can be incorporated to the     standard of care of ESRD patients by working in conjunction with the dialysis unit staff.   "
192197|NCT00363974|"     The purpose of this study is to determine if the drug, called AEG35156, can be safely given     to AML patients and whether it effectively reduces levels of a protein (XIAP) to increase the     sensitivity of cancer cells to chemotherapy (ara-C and idarubicin) in patients with     refractory or relapsed AML.   "
192198|NCT00363987|"     Current expert opinion based consensus guidelines recommend usage of α-Keto analogues of     essential amino acids in the diet of diabetic nephropathy patients, along with restricted     protein diets. This study is designed to explore whether alpha-Keto Acid supplementation with     low protein diet will retard progression of type 2 diabetic nephropathy and also to assess     effects of such supplemented diets on nutritional and other parameters in this patient group.   "
192199|NCT00364000|"     End-stage renal disease (ESRD) is a state of increased arterial stiffness of extensive vessel     calcifications, compared with the non-renal population. Both arterial stiffness and arterial     calcifications are potent predictors of all-cause and cardiovascular mortality in ESRD     patients. Several studies have documented the direct relationship between the extent and     severity of arterial/coronary calcifications and outcome in dialysis patients. The     relationship is strong no matter if arterial calcifications were quantified by electron-beam     computed tomography or a radiological calcification score. Calcifications are early and     progressive events in these patients. PWV is strongly related to the degree of sonographic     determined arterial calcifications and EBCT-derived coronary artery calcium score in chronic     kidney disease patients.      Calcium-based phosphate binders are associated with progressive coronary artery and aortic     calcification, especially when mineral metabolism is not well controlled.      According to recent studies, sevelamer hydrochloride is a potent non-calcium-containing     phosphate binder, well tolerated in ESRD. Compared with calcium-based phosphate binders,     sevelamer is less likely to cause hypercalcemia, low levels of PTH, and progressive coronary     and aortic calcification in hemodialysis patients. Moreover, sevelamer has a favorable effect     on the lipid profile.      Less is known about the relationship between sevelamer treatment and progression of arterial     stiffness. To date, there is one single study examining the influence of sevelamer (versus     calcium carbonate) on the evolution of arterial stiffness in a very small number (N=15) of     haemodialysis patients. These study used the same patients as historical controls, thus being     methodologically rather weak. Moreover, the follow-up was quite short - 6 month.      The aim of the trial is to to quantify, in a randomized opened-labeled controlled trial the     effect of sevelamer hydrochloride on the evolution of arterial stiffness parameters (pulse     wave velocity and the augmentation index) in chronic haemodialysis patients and to correlate     these parameters with arterial calcification assessed by a previous described radiological     score of arterial calcification and echocardiographic parameters (left ventricular     hypertrophy, LV dilatation, systolic and diastolic dysfunction).   "
192200|NCT00364013|"     The purpose of this study is to determine the treatment effect of panitumumab in combination     with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer   "
192201|NCT00364026|"     This is a research study of a new experimental drug called darusentan. Darusentan is not     currently approved by the U.S. Food and Drug Administration (FDA) for use in the United     States, which means that a doctor cannot prescribe this drug. The purpose of this study is to     determine if darusentan is effective in reducing systolic blood pressure in subjects with     resistant systolic hypertension, despite treatment with full doses of three or more blood     pressure lowering drugs, including a diuretic.   "
192202|NCT00364039|"     The purpose of this study is to determine the safety and tolerability of AV650 in healthy     subjects given single and multi-doses under fasted and fed conditions.   "
192203|NCT00364052|"     Null Hypothesis:      There is no significant difference in the incidence of CMV infection when using oral     valganciclovir or ganciclovir as prophylactic anti-viral therapy.      Alternate Hypothesis:      There exists a significant difference in the incidence of CMV infection when oral     valganciclovir is used for CMV prophylaxis rather than oral ganciclovir. A formal hypothesis     to be tested should be defined.   "
192204|NCT00364065|"     The purpose of this study is to see if the Ferris PainWrap is effective in the treatment of     chronic low back pain.   "
192560|NCT00367679|"     This is a phase 2 open-label, multicenter, non-randomized study to evaluate the safety and     efficacy of oral pazopanib as neoadjuvant treatment for patients with stage 1A, 1B, IIA or     IIB (to T2) resectable Non-Small Cell Lung Cancer (NSCLC).   "
192205|NCT00364078|"     Transitoriness can be defined as confrontation with life's finitude. Cancer patients are     perceived to experience this confrontation due to their diagnosis. It is perceived to impact     cancer patients' ways of coping with the disease situation. In this study, cancer patients'     levels of uncertainty, transitoriness and their perceived locus of control are assessed. It     is aimed at exploring the association of uncertainty, locus of control, transitoriness and     quality of life. If a stronger correlation of one or the other issue with quality of life can     be discovered, it will inform the development of an adequate evidence-based nursing     intervention to better support patients' coping with the disease.   "
192206|NCT00364091|"     The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025%     ophthalmic solution compared with placebo or an active control in subjects with seasonal     allergic conjunctivitis   "
192207|NCT00364104|"     The investigators hypothesize that the Helicobacter pylori bacterium decreases iron from the     stomach and that this effect of the infection can be identified among persons with iron     deficiency as well as among persons with normal iron stores. The aim of this study is to     determine whether Helicobacter pylori eradication in children is followed by an increase in     markers of iron stores after six to twelve months of treatment.   "
192208|NCT00364117|"     The purpose of this study is to integrate Remote Presence technology in order to increase the     number of timely patient discharges before 11 am from the medical center.   "
192211|NCT00364156|"     This randomized double-blind, placebo-controlled will determine the relative efficacy of     standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After     completing the eligibility screening, 600 treatment-seeking smokers will be randomized to     receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or     extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral     counseling. The primary outcome will be biochemically verified abstinence from smoking at the     end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after     treatment is discontinued), and time to failure. We hypothesize that ET will produce     significantly higher quit rates than ST; however, the benefit of ET will last only so long as     treatment is continued. Support for this hypothesis would indicate that maintenance therapy     with TN should be considered.   "
192212|NCT00364169|"     The purpose of the study is to reduce the incidence of postoperative constipation by     systematic nurse assessment, interventions and evaluation, in the first month after thoracic     surgery.   "
192213|NCT00364182|"     This study is designed to evaluate BeneFIX infused as prophylaxis regimens, compared with     BeneFIX administered as an on-demand regimen only. In the trial, subjects will participate in     4 study periods. The first period is a 16-week on-demand treatment, during which subjects     will utilize BeneFIX to treat bleeding events episodically only as they occur (i.e.,     on-demand treatment). At the end of this period, subjects will be randomly assigned to 1 of 2     BeneFIX prophylaxis regimens: either 100 IU/kg once weekly or 50 IU/kg twice weekly, and     followed for 16 weeks. At the end of this period, subjects will use on-demand treatment for 8     weeks. The purpose of this 8-week period is to mitigate the potential carry-over effect of     the prior prophylaxis regimen on bleeding frequency. Following this 8-week on-demand     treatment, subjects will cross-over and receive the alternate study prophylactic regimen for     16 weeks.      The primary endpoint is annualized number of bleeding episodes, compared between the first     on-demand period and each of the prophylaxis regimens. A comparison of annualized bleeding     episodes between the two prophylaxis regimens will also be performed. Subject-reported     outcomes will also be collected using a patient diary. At 24 and 48 hours following the onset     of each joint bleeding episode, information on pain, sleep, and work will be collected.     Additional data on physical functioning will be recorded on the diary at the end of the     16-week on-demand period, and at the end of each prophylaxis period. Information on safety     will also be collected.      Each subject will participate in this study for approximately 59 weeks (15 months), including     a screening period of up to 3 weeks, an initial 16-week on-demand period, two prophylaxis     treatment periods of 16 weeks each, separated by an 8-week on-demand treatment period.      A modified FIX recovery study will be performed once during each prophylaxis period.      The study diary will also be used by subjects to collect secondary endpoints. These     endpoints, which are subject-reported outcomes, will be recorded in the diary at 24 and 48     hours following the onset of each joint bleeding episode. Additional data on physical     functioning will be recorded on the diary at the end of the 16-week on-demand period, and at     the end of each prophylaxis period.      Patients will be recruited in the United States, Canada, Europe and Russia.   "
192214|NCT00364195|"     This is a Phase II study designed to evaluate whether the co-administration of a fixed dose     of tesmilifene and a standard regimen of docetaxel alters the plasma pharmacokinetics of     docetaxel. This study will also assess the safety and efficacy of the tesmilifene/docetaxel     combination in metastatic breast cancer patients.   "
192215|NCT00364221|"     The metabolic syndrome is a collection of health risks that includes obesity, high blood     pressure, high triglycerides, high blood sugar, low good cholesterol, and resistance to     insulin. The purpose of this study is to find out if the medication, rosiglitazone,     influences levels of fat cell proteins and alters insulin resistance in nondiabetic persons     with the metabolic syndrome. This is an early step to see if a medication, such as     rosiglitazone, will be beneficial in people who have the metabolic syndrome.   "
192216|NCT00364234|"     The proposed 6 month pilot and feasibility randomized trial will evaluate LMMS as an anabolic     stimulus to bone in 30 adults on maintenance hemodialysis. The intervention will consist of     20 minute daily sessions in the home standing on an active LMMS platform or a placebo device     that emits an audible hum suggestive of an active device. Each device contains an electronic     monitor that documents adherence. The study will examine trabecular bone volume fraction     (bone volume/total volume, BV/TV %) and architecture using microMRI, and cortical volumetric     BMD and dimensions using QCT at baseline and 6 months. The hypothesis is that active LMMS     will results in greater mean changes in trabecular and cortical parameters in hemodialysis     patients. The proposed study will test the feasibility of conducting the intervention in     dialysis patients and will generate preliminary data on rates of change in trabecular and     cortical parameters in the active and placebo groups.   "
192217|NCT00364247|"     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety     of the administration of 3 different dose levels of CG5503 compared with oxycodone and with     placebo in patients who have had a bunionectomy, and to assess the safety of the drug for 9     days after patients are discharged from the hospital.   "
192218|NCT00364260|"     The purpose of this study is to determine if using Eprex, to maintain hemoglobin within the     normal range, will prevent or delay the progression of left ventricular mass growth.   "
192426|NCT00365911|"     Blood sample is taken for measurement of serum creatinine, cystatin C, clone V haemoglobin,     cholesterol, urine acid, glycemia and CRP.      The medical file is gathered. There will be searched for an association between renal     function and cardiovascular risk factors and risk factors by exposition to toxic substantia     during work.   "
192219|NCT00364273|"     GSK159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (LABA), which     is being developed for once daily treatment of asthma and COPD as part of a combination     product with a once daily inhaled corticosteroid and also as a standalone product for the     treatment of COPD. Stimulation of the beta-2-agonist in the lung mainly relaxes bronchial     smooth muscle cells which results in bronchodilation. Unwanted systemic side effects related     with beta-2-agonist treatment such as tachycardia, tremor, hyperglycemia and hypokalemia are     limited by local administration and also tend to show tachyphylaxis.      The LABAs that are currently available (e.g., salmeterol, formoterol) require twice-daily     administration, given their duration of action. Therefore, there is significant opportunity     for a once-daily inhaled medication to improve patient compliance and overall disease     management by providing sustained, 24-hour bronchodilation.   "
192220|NCT00364286|"     The goal of this clinical research study is to learn if dasatinib can help to control Chronic     Lymphocytic Leukemia (CLL). The safety of the drug will also be studied.      Optional Procedures: You will be asked to have additional blood samples drawn. These samples     will be used to see how the disease is responding to the drug.   "
192221|NCT00364299|"     Background: The aspiration of contaminated secretions pooled above the endotracheal tube cuff     secondary to inadvertent falls of cuff pressure is the main pathogenic mechanism of     ventilator-associated pneumonia (VAP). Aim of the study: To assess the efficacy of an     automatic device for the continuous regulation of tracheal tube cuff pressure in decreasing     the incidence of VAP.   "
192224|NCT00364338|"     Subjects that participate in the practical workshop will improve their metabolic indexes,     decrease their weight and improve their quality of life, in contrast to the participants that     will take part in the nutritional consulting sessions   "
192225|NCT00355056|"     The Purpose of this study is to evaluate the impact of percutaneous closure of a patent     foramen ovale (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of     migraine headaches.   "
192226|NCT00355069|"     This 3-year, multi-site study focuses on the translation of cost-effective methods to bring a     chronic care model to the care of poor, minority, inner-city children with asthma, at risk of     the worst outcomes for the leading chronic disease of children.      The specific aims are to:        1. Develop a computer support system to deliver peer-driven, patient-linked Guideline          prompts at the point of care using affordable information technology;        2. Evaluate the effect of the Guideline prompt system on the process and outcomes (symptom          control, health-related-quality-of-life, ED and hospitalizations) of asthma care; and        3. Evaluate the added effect on outcomes of family-focused, supportive education delivered          by a community health worker.      The key product of the computer support system is a guideline prompt that serves as the     mechanism for integrating patient specific data with standards of care. 548 children, ages     5-18, with physician diagnosed asthma, enrolled in one Medicaid Managed Care Organization in     CT, and receiving care at one of four Federally Qualified Community Health Centers will be     recruited. All sites will have access to the computer support system and the to-be-developed,     Guideline-Driven Clinical Standards of Asthma Care. In Phase I (12 months), the effect of     prompts delivered at the point of care on patient outcomes will be compared to the effect of     no-prompt care. In Phase II (6 months), the effect of family-focused, supportive education     will be assessed in combination with prompted care compared to no-prompt care and compared to     no education. All patients will receive standard screening and outreach to keep appointments.     Data will be obtained from medical records, medical and pharmacy claims data as well as     patient and parent interviews at baseline and quarterly for 18 months.   "
192227|NCT00355082|"     This study is being conducted to determine the effectiveness of a lower monotherapy dose of     lamotrigine than that currently approved.   "
192228|NCT00355095|"     The purpose of this study is to determine the safety and efficacy of erythropoietin as an     add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis.   "
192229|NCT00355108|"     Scientific Objectives Primary objective : Demonstrate that oral intake of tranexamic acid     significantly reduces the risk of epistaxis occurrence, estimated by the average monthly     duration of episodes of epistaxis.      Secondary objectives :        -  Document the benefit of tranexamic acid on the amount of haemoglobine and quality of          life of patients.        -  Identify scalable and genetic factors of response to the treatment by tranexamic acid.        -  Describe compliance and tolerance of the treatment. Method Experimental Design We          suggest the realisation of a randomised comparative clinical trial versus placebo, with          a crossover of random alternated periods of three months over a total of six months.      Study Population 213 affected patients, displaying sufficiently invalidating epistaxis to     require a basal treatment, will be recruited and followed every 3 months. Recruitment will     lean on teams who are part of the national French network in close collaboration with the     reference centre for the Rendu-Osler disorder, appointed to Lyon on the 19th of November     2004. Follow up of the study will be carried out by the Clinical Investigational Centre of     the related towns.      Outcome measures The main criterion of efficacy is the average duration of epistaxis, the     secondary criterion of efficacy is the average number of epistaxis measured per month.     Tolerance will be analysed according to the occurrence of venal or arterial thrombosis and     allergic accidents. Venal thrombosis will systematically be sought by an inferior limbs     echodoppler. Response markers will be sought through modelisation incorporating     environmental, phenotypic and genetic factors.   "
192274|NCT00355693|"     Whether patient-maintained sedation (the patient controls his/her degree of sedation using a     hand-held device) using the drug propofol is safer and more effective when using     deteriorating reaction time as an added safeguard against the potential for over sedation in     a groups of patients undergoing oral surgery, general dentistry and colonoscopy.   "
192230|NCT00355121|"     The purpose of this study is to evaluate the immunogenicity and safety of the concomitant     administration of Menactra® vaccine and DAPTACEL® vaccine.      The main objectives are:      Immunogenicity:      To evaluate the antibody responses to both vaccines when Menactra vaccine is given     concomitantly with DAPTACEL® compared to when either vaccine is given alone.      Safety:      To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are     administered concomitantly compared to when each vaccine is given alone.   "
192231|NCT00355134|"     This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod     compared to placebo on efficacy parameters in patients with relapsing-remitting multiple     sclerosis (RRMS).   "
192232|NCT00355147|"     The purpose of this study is to develop and evaluate the local adaptation of existing stroke     prevention tools into practice. A stroke prevention program is a collection of materials     including written materials like pamphlets and brochures, videotapes and training guides for     stroke survivors and evidence based guidelines for the doctors that provide care for them.     Other tools that may be used in a stroke prevention program include devices that help     patients monitor medical symptoms at home like home blood pressure machines or blood sugar     monitors and messaging devices that allow reporting symptoms from home to a health care     provider.      We hypothesized Veterans with stroke who receive the Veteran Stroke Prevention Program would     engage in better medication compliance and stroke specific quality of life compared to those     who did not receive the program.   "
192233|NCT00355160|"     The study serves to investigate the type and prevalence of non-rhinologic headaches seen     through a academic otolaryngology practice.The study encompasses survey questionnaires,     review of CT images, and physical examination/nasal endoscopy findings.   "
192234|NCT00355173|"     The Lubo cervical collar is a device that simultaneously maintains cervical spine control and     keeps an open airway in a non-invasive manner. The purpose of the device is to manage     cervical spine control and airway protection in the trauma patient.   "
192290|NCT00355901|"     To assess the effects of visilizumab on the safety of subsequent salvage therapies in     subjects who experienced disease progression in a previous visilizumab study and subsequently     received salvage therapy.   "
192344|NCT00356642|"     The purpose of this study of this study is to investigate the safety, tolerability and     pharmacokinetics of GW842470X in patients with atopic dermatitis. GW842470X is an inhibitor     of phosphodiesterase 4 (PDE4).   "
192235|NCT00355186|"     Title: SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction     (SWISS-AMI).      Study population: Patients with acute myocardial infarction, treated with primary PCI.      Objective: To determine whether intracoronary infusion of BMCs improves recovery of left     ventricular function after acute myocardial infarction treated by PCI      Design: Multi-center, randomized, controlled clinical trial with central core lab analysis     for MRI.      Therapy: Intracoronary infusion of BMCs in the infarct related artery at 5-7 days or 3-4     weeks after successful primary PCI      Primary Endpoint: Change in global left ventricular ejection fraction (LVEF) at 4 months     relative to baseline measured by quantitative MRI.      Secondary Endpoints:        -  Change in LVEF at MRI at 12 months        -  Change in regional left ventricular wall motion and thickness at 4 and 12 months.        -  Change in infarct size at 4 and 12 months as assessed by delayed enhancement technique          by MRI        -  Analysis of the myocardial infarct size and transmurality, time to PCI and coronary flow          characteristics after PCI as predictor of LV remodeling and change after cell therapy        -  Change in myocardial perfusion at 4 and 12 months        -  Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)        -  Major adverse cardiac events (MACE: death, myocardial infarction, TVR (ACBP or PCI,          stroke, hospitalization for cardiac reasons) at 12 months      Interventions:        -  Aspiration of 50 ml bone marrow (<24 hours) prior to administration        -  Intracoronary balloon-based infusion of 10 ml BMCs        -  Cardiac MRI at baseline (resp. at hospital discharge), at 4 and 12 months      Therapy groups: Bone marrow-derived stem cells infusion in the successfully revascularized     infarct related vessel at day 5-7 or day 21-28.      Control group: Management according to the state of the art medical therapy after     successful primary PCI.      Safety: A study independent safety committee will analyze the clinical results after the     first 60 patients.   "
192236|NCT00355199|"     Multicentric randomized phase III study comparing high doses of chemotherapy with Rituximab     followed by auto-transplant HPC versus CHOP plus Rituximab as first line therapy in high risk     patients with DLBCL Non-Hodgkin's lymphomas.   "
192237|NCT00355212|"     Ethanol injection has been for many years the standard approach as percutaneous treatment of     non-surgical early hepatocellular carcinoma in cirrhotic patients. Radiofrequency ablation     has been proposed as an alternative approach and some retrospective and prospective     comparative trials indicated its better performance for the local control of the disease in     comparison to ethanol injection. Some prospective randomized studies from Japan and from     Taiwan reported also an increase of overall survival in the patients treated by     Radiofrequency. Aim of this study is to compare the two techniques in a prospective     randomized trial in western patients.   "
192238|NCT00355225|"     The study aims at assessing which of two distribution channels for insecticide treated     bendnets (ITNs), social marketing vs. social marketing coupled with free distribution through     ante-natal care, is most effective in reaching groups at high risk of malaria, i.e. pregnant     women and children under 5.   "
192239|NCT00355238|"     The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the     growth of advanced liver cancer. The safety of this treatment will also be studied.   "
192240|NCT00355251|"     To determine the influence of atorvastatin on plasma viral replication when the latter is     given before and during highly active anti-retroviral therapy (HAART) in patients with HIV     infection and viral suppression.   "
192241|NCT00355264|"     The purpose of this study is to evaluate the ability of Phenoptin to control blood     phenylalanine levels in subjects who have hyperphenylalaninemia due to a primary BH4     deficiency and to evaluate the safety of Phenoptin in this population.   "
192242|NCT00355277|"     The aim of this study is to assess the local anaesthetic effects of amitriptyline applied on     the skin of human volunteers, considering the differential effects on mechanic and thermic     sensitivity, the local and general tolerance, and the systemic absorption of the drug. The     solution used for dilution of amitriptyline is the only one known to allow transcutaneous     absorption of the drug [1]. Considering that the peripheral sensitive fibre is a possible     site of action of tricyclic antidepressants for relieving neuropathic pain [2,3], this is a     first step study before further assessment of the therapeutic effects of transcutaneous     amitriptyline.   "
192243|NCT00355290|"     The primary hypothesis of this trial is that changes in oral vitamin K intake, based on     simple food registries, may be superior to conventional changes in doses of medications in     order to stabilize chronic oral anticoagulation.   "
192244|NCT00355303|"     The purpose of this study is to determine whether induction of labor with vaginal misoprostol     application will result in fewer cesarean deliveries than vaginal PGE2 gel application in     women with premature rupture of membranes at term.   "
192392|NCT00364533|"     The purpose of this study is to test in patients who have had hip replacement surgery the     effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503     compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to     assess the safety of the drug for 9 days after patients completed the double blind period.   "
192245|NCT00355316|"     This study is designed to determine whether molecular detection of breast cancer cells in the     peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of     progression-free and overall survival. Stage IV breast cancer patients who have measurable     breast cancer metastases and are initiating a regimen of systemic therapy are eligible for     enrollment. Multi-marker real-time RT-PCR analysis will be performed on peripheral blood     specimens from 92 breast cancer patients and 120 healthy volunteers. Peripheral blood     specimens from breast cancer patients will be obtained at the time of study entry (prior to     initiation of systemic therapy) and at serial time points during follow-up. Subjects will be     followed longitudinally until death, although the study has been powered so that the primary     objective can be addressed after 12 months of follow-up. Healthy volunteers will be asked to     provide a blood sample at time of enrollment but will not be followed.   "
192246|NCT00355329|"     We aimed to use Tongue Acupuncture (TAC) to assess for any change in brain function.   "
192247|NCT00355342|"     This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits     will include lung function tests and scans of your bones. The purpose of this study is to     determine the effect of the steroid component of an inhaled product on bone mineral density     in patients with Chronic Obstructive Pulmonary Disease (COPD).   "
192248|NCT00355355|"     The purpose of the study is to assess the survival of patients treated with Litx™ versus     standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC),     and to demonstrate the safety of Litx™ therapy.      Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology,     Bellevue, Washington), and a light generating device, composed of light-emitting diodes     (LEDs), that is energized by a power controller and percutaneously placed in the target     tissue inside the body.   "
192401|NCT00364650|"     We hypothesize that the administration of a combination of high numbers of probiotic bacteria     will maintain normal bowel function and significantly moderate or obviate Immunosuppression     Associated Diarrhea following kidney transplantation.   "
192249|NCT00355368|"     Emergency intubation of patients in intensive care is a high-risk endeavour. For many     decades, succinylcholine has been the neuromuscular blocking agent of choice. However,     succinylcholine may have life-threatening side effects and is contraindicated in a variety of     diseases relevant in intensive care. The nondepolarizing agent rocuronium has been propagated     as alternative for succinylcholine. Though a recent meta-analysis found no difference in     intubating conditions between succinylcholine and rocuronium in elective cases, there are no     data in emergent cases in intensive care. The aim of the present study is to compare     succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length     of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of     intubation, and 5) desaturations.   "
192250|NCT00355381|"     Research shows that patient satisfaction with medical care correlates strongly with how     satisfied they are with the ease of getting information from their providers regarding their     medical condition. Although the Internet is a wonderful source of information for patients,     research has shown that, unmediated, it comprises a potential quagmire of information poorly     matched to users needs. Providers typically do not have enough time to fulfill all of their     patients' information needs. One strategy to meeting the patient's information needs is to     introduce librarians trained and experienced in consumer health information services into the     relationship between the patient and the provider. One recently described tactic is for     providers to provide information the way they of provide treatment-through an information     prescription (IRx) filled by a librarian. The librarian fills the prescription by offering     information services tailored to the needs of individual patients. At Johns Hopkins, we have     piloted such a tactic, and in this project, extend and evaluate it. The research hypothesis     is that provision of an IRx will improve patient satisfaction, provider knowledge and     attitudes regarding patient information needs, and the efficiencies of care.   "
192251|NCT00355394|"     Migraine is common in children and is one of the most common etiologies of headache leading     to emergency room presentation in children. Despite this, few studies have investigated the     treatment of acute migraine headache in the emergency room. We will perform a prospective,     double-blind, placebo-controlled study of metoclopramide versus placebo in the treatment of     acute migraine headache. The primary outcome will be the number of subjects headache free at     two hours.   "
192252|NCT00355407|"     The purpose of this study is to find out if Darbepoetin alfa is effective in treating low red     blood cell levels after allogeneic stem cell transplant. Darbepoetin alfa has been shown to     help raise red blood cell levels without blood transfusions.   "
192253|NCT00355420|"     Femur fractures are a common injury in the Pediatric population. Despite their high incidence     little do we know about the long term implications on the bones' length. Our main goal is to     clarify this obscure issue by assessing the femoral and tibial length as determined by the     fractures, measuring techniques and treatment modalities   "
192254|NCT00355433|"     The purpose of this study is to compare first urge, strong urge, and maximum capacity, and     perception of discomfort during urodynamic testing between room temperature and body     temperate saline. Twenty-four non-pregnant females referred to the urogynecology clinic for     bladder testing will be enrolled into the study. Each patient will serve as her own control,     undergoing the bladder testing with both room temperature and body temperature saline.   "
192255|NCT00355446|"     The purpose of this study is to assay human aqueous for bimatoprost and the presence of any     metabolites, especially prostaglandin analogs. Hypothesis:Bimatoprost is not metabolized to a     prostaglandin F-2-alpha analog in human eyes        -  Bimatoprost levels in human aqueous peak approximately three hours post dosing   "
192256|NCT00355459|"     The purpose of this research project is to determine the effects of oral tetracycline such as     Minocycline (Minocin) on tear film composition and tear lipid (meibomian gland secretions)     characteristics in patients with chronic Blepharitis and associated dry eyes.   "
192257|NCT00355472|"     This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4     positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).   "
192258|NCT00355485|"     The purpose of this research project is to study the effect of micordermabrasion to try to     improve the appearance of facial acne. The microdermabrasion machine is a hand-held device     that directs pressurized aluminum oxide crystals at its target accompanied by a suction     device. It is not yet clear how much improvement can be seen with these treatments or exactly     how the skin's response causes these improvements. In this study, we are interested in     learning how well microdermabrasion works to improve the symptoms of acne.   "
192259|NCT00355498|"     Amyloid senile plaques (SPs) and neurofibrillary tangles (NFTs) are neuropathological     hallmarks of Alzheimer's disease (AD) that also accumulate in key brain regions in     association with normal aging. This project will expand an established program in early     detection and prevention of AD designed (1) to identify presymptomatic persons most likely to     benefit from early intervention and (2) to provide an objective, noninvasive means to monitor     therapeutic trials.   "
192260|NCT00355511|"     The purpose of this study is to assess the impact of a multidisciplinary team clinic     including a clinical pharmacist, a registered nurse (RN), dietician and physician providing     short-term sub-acute management of patients with heart failure on patient outcomes and the     quality of medication use. Patients being discharged from the emergency department with a     diagnosis of heart failure will be eligible for this study. We believe that emergency room     visits, hospitalization and deaths secondary to heart failure will decrease secondary to this     program.   "
192261|NCT00355524|"     The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug     enters and leaves the blood and tissues over time), safety, tolerability and antiviral     activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral     agents in treatment-experienced, human immunodeficiency virus (HIV)-1 infected children and     adolescents.   "
192308|NCT00356135|"     This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel     75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of     study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous     coronary intervention (PCI) with placement of a stent, performed to treat acute coronary     syndrome (ACS).   "
192438|NCT00366080|"     The purpose of this study is to assess the effectiveness and safety of the drug GSK189254 in     treating patients with narcolepsy.   "
192262|NCT00355537|"     Diabetes is a major cause of peripheral vascular disease(PVD) and is associated with male     hypogonadism. Diabetes and PVD are both associated with arterial stiffness and intima -media     thickness which are also related to severity of the clinical syndrome of PVD. Artificially     induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to     improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot     study is to assess the effect of testosterone treatment on PVD arterial stiffness and     intima-media thickness in men with type 2 diabetes and hypogonadism,   "
192263|NCT00355550|"     The purpose of this study is to determine whether Ketasyn, a compound that increases energy     availability in the brain, improves memory in older adults with normal loss of memory     abilities since early adult life.   "
192264|NCT00355563|"     The study has been designed to comparatively evaluate the safety and effectiveness of the     PAS-Port Proximal Anastomosis System and conventional suturing techniques for creation of the     connection between graft veins and the aorta in patients undergoing coronary artery bypass     graft surgery for treatment of coronary artery disease. Patients in the study will have a     coronary angiogram approximately 9 months following surgery to determine the patency of vein     grafts created using either the automated PAS-Port or hand sewn methods. Safety will be     evaluated by documenting the occurence of adverse clinical events and evealuating possible     association with either method.   "
192265|NCT00355576|"     The objective of this study is to compare two combinations of drugs, minocycline and creatine     or celecoxib and creatine, in a phase II trial designed to determine which combination is     more effective for ALS.   "
192266|NCT00355589|"     The purpose of this study is to determine if there is greater blood pressure reduction using     ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.   "
192267|NCT00355602|"     Ulcerative colitis (UC) is an acute and chronic inflammatory bowel disease, whose cause is     unknown. However, it is widely accepted that bacteria living in the large bowel are essential     for the development of the disease. Intuitively, therefore, a logical approach to treatment     would be to use antibiotics. However, antimicrobial chemotherapy has been unsuccessful in     managing acute colitis, and has had only limited benefit in long-term treatment. The failure     of antibiotics in UC arises from the fact that no-one has tried to identify which bacteria     are involved in causing disease, and equally importantly, nobody has targeted appropriate     antibiotics to knock out the specific bacteria in question, in a systematic way. Despite     this, increasing evidence implicates bacteria living on the lining of the bowel being     involved in UC. Our aim, therefore is to identify bacteria colonizing the mucosal surface in     the lower large intestine and to determine the antibiotic sensitivities of those the     investigators believe to be particularly involved in the disease, such as enterococcit,     peptostreptococci and enterobacteria. Because the investigators have already studied     resistance to antimicrobial in many mucosal isolate, the investigators plan ot focus on using     a combination of two antibiotics in this work. A controlled trial will test the benefit of     using these antibiotics over a period of one month and then the patients will be followed up     over a six month period. The investigators will be looking for significant long-term     improvements, and a reduction in drug use following antibiotic therapy.   "
192268|NCT00355615|"     The primary objective of this study is to determine the efficacy of once-daily rosuvastatin     in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day     0) to the end of the 12-week double-blind treatment period.   "
192269|NCT00355628|"     This study is a Phase II open-label study to investigate the recommended conversion ratio     (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in     cancer patients.   "
192270|NCT00355641|"     The primary objective of this study is to assess the safety and tolerability of ropinirole XR     in the long-term treatment (up to 52 weeks)of adults with RLS.   "
192271|NCT00355654|"     The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to     allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as     Prevenar®.      Primary Objective:      To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers     at 11-18 months of age.      Secondary Objectives:        -  To describe the incidence rate of severe fever within four days post-vaccination        -  To describe the antibody responses to all antigens in a subgroup of subjects at baseline          and post-vaccination.   "
192272|NCT00355667|"     The purpose of this study is to compare therapeutic effects of furosemide, a short-acting     loop diuretic, and azosemide, a long-acting one, in patients with heart failure, and to test     our hypothesis that long-acting diuretics are superior to short-acting types in heart     failure.   "
192273|NCT00355680|"     To Demonstrate that indigenous green laser produces similar treatment effect on the retina     when compared with already available green laser.   "
192393|NCT00364546|"     The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50     mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in     patients who have chronic pain.   "
192275|NCT00355706|"     1. To demonstrate whether:           i. Facet joint nerve blocks have therapeutic value beyond the duration of local          anesthetic effect.           ii. Addition of Depo-steroid provides additional relief of thoracic facet joint pain          when used with facet joint nerve blocks.        2. To demonstrate whether or not there are clinically significant improvements in function          of patients who receive thoracic facet joint nerve block with Depo-steroid compared to          patients randomized to Group I who receive only local anesthetic blocks.        3. To determine the adverse event profile in both groups   "
192276|NCT00355719|"     The purpose of this study is to evaluate the influence of nevirapine in exposure to     atazanavir boosted with ritonavir, in steady state equilibrium, in HIV-infected adult     patients.   "
192277|NCT00355732|"     To evaluate and compare two methods of weaning from mechanical ventilation in patients with     chronic obstructive pulmonary disease (COPD) where the extubation failed.   "
192309|NCT00356148|"     This is a single center trial to compare the rate of surgical site infection (SSI) in normal     (BMI equal to or less than 25; Control Group)) and overweight (BMI over 25) women who are     undergoing breast cancer surgery. The overweight patients are further randomized into two     groups; in one group patients receive prophylactic antibiotics (ampicillin/sulbactam;     Prophylaxis Group), in the other they do not (No Prophylaxis Group).   "
192278|NCT00355745|"     In the United States, breast cancer is the most common cancer occurring in women (excluding     cancers of the skin) and the second most common cause of death from cancer in women (after     lung cancer). Approximately 182,800 new cases per year occur in the United States, causing     40,800 death cases per year. Breast cancer is the leading cause of death in women aged 44-50     years. The 5-year survival rate is 60% overall but is greater than 80% for early disease.      If diagnosed at an early stage, breast cancer has an encouraging cure rate: up to 97% of     women diagnosed with localized breast cancer will survive five years after their diagnosis.     Even if the cancer is found at a more advanced stage, new therapies have enabled many people     with breast cancer to experience the same quality of life as before their diagnosis.      Breast ultrasound (US) is an extremely useful modality in the diagnosis of breast disease in     the symptomatic clinic. It is routinely used as an adjunct to x-ray mammography and clinical     examination and, with younger patients it may be the sole imaging modality. It has     well-established value in differentiating between malignant and benign solid lesions in some     cases, however, it cannot replace fine needle aspiration and core biopsy.      Conventional breast US scanning is highly operator- dependent, requiring skillful probe     manipulation and the mental ability to envisage 3-D tissue structure. Acquiring 3-D US data     sets may be advantageous, making it easier to see and interpret 3-D structures, boundaries     and interactions.      CBUS™, Circular Breast Ultrasound Scanner is indicated to improve significantly breast images     obtained by ultrasound systems. The CBUS™ system automatically acquires a complete breast     image and constructs a high quality 3D image of the scanned breast. These images provide     diagnostic information of the complete volume of breast tissue including blood flow in a     single ultrasonic 3D image.      In this clinical study, the CBUS™ Circular Breast Ultrasound Scanner will be used to     automatically image the complete breast and provides a high quality 3D image of the scanned     breast.   "
192279|NCT00355758|"     : Researchers would like to see if a new test called SELDI (Surface Enhanced Laser Desorption     Ionization) analysis can predict biopsy results better than PSA tests.   "
192280|NCT00355771|"     The purpose of this study is to investigate, whether levocetirizine 5 mg relieves nasal and     ocular symptoms of persistent allergic rhinitis and reduces increased airway resistance and     sleep impairment due to this condition.   "
192281|NCT00355784|"     With the alarming increase in the prevalence of obesity, identifying factors that predispose     individuals to weight-gain is of critical importance. Even when caloric intake and physical     activity levels are well controlled, susceptibility for weight-gain is heterogeneous. Basal     metabolic rate (BMR) represents the largest portion of daily energy expenditure in normal     adults, and as such, variability in BMR among individuals can be a major factor in     determining the susceptibility for gaining weight. However, factors responsible for this     variability in BMR and resistance to weight-gain remain unclear. Our preliminary data     indicate that high-normal growth hormone (GH) concentration is associated with resistance to     weight-gain in rats when overfed and greater weight-loss in humans when underfed. In     addition, the investigators have found that the pulsatility of GH secretion has profound     effects on several metabolic processes. Therefore, together these findings suggest that     endogenous GH secretion is associated with body weight regulation, and the pulsatility (peak     amplitude) of GH secretion, rather than the absolute GH concentration, per se, may be     responsible for this effect. Because GH influences many of the key metabolic processes that     contribute to BMR (e.g.; protein synthesis, proteolysis, substrate cycling), the     investigators anticipate that the resistance to weight-gain in persons with elevated GH     concentrations will be associated with an increase in BMR due to acceleration of some or all     of these processes. Our overall hypothesis is that increased GH secretion can protect against     weight-gain due to an augmentation of major metabolic processes that contribute to BMR.     Identifying factors responsible for predisposing individuals to weight-gain will lead to     establishing improved methods for reducing the prevalence of obesity.   "
192282|NCT00355797|"     This is a randomized, prospective, single-blinded, multi-center study involving approximately     1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness     of Closed Loop Stimulation (CLS) rate adaption technology over both standard rate responsive     technology (R) and non-rate responsive mode (DDD) during activities of daily living (ADL).   "
192283|NCT00355810|"     This randomised, double blind, cross-over study compares the effect (symptoms, fecal     bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF     1298 with placebo in patients with irritable bowel syndrome. The results are related to     dietary habits, food intolerance and food allergy.   "
192284|NCT00355823|"     The investigators have developed a new non-invasive medical device called the Bioelectric     Field Imager. They plan to use this device to measure the electric field near small lancet     wounds in 60 volunteers. Their hypothesis is that the electric field is an early stimulus for     wound healing and the magnitude of this field will vary with wound healing capability. The     investigators will compare the electric fields near arm and leg wounds in males and females     in the age groups of 18-30 and 65-80. In addition they will measure these wound fields in     diabetics and near chronic ulcers.   "
192285|NCT00355836|"     The purpose of this study is to assess the therapeutic benefits of motor imagery training in     stroke patients with persistent motor weakness.   "
192286|NCT00355849|"     A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder [also known as     AIR® Inhaled Insulin][AIR® is a registered trademark of Alkermes,Inc.] in patients with Type     2 diabetes who are currently being treated with once daily insulin glargine injections. The     present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily     insulin glargine injections.   "
192287|NCT00355862|"     The purpose of this study is to determine the safety and efficacy of sirolimus-based     immunosuppressive therapy in patients following orthotopic liver transplantation (OLT) for     hepatocellular carcinoma (HCC), with regard to HCC recurrence-free patient survival.   "
192394|NCT00364559|"     The purpose of this study is to determine whether rosuvastatin is effective in the management     of acute phase of intracerebral hemorrhage and if it impact outcome by NIHSS.   "
192288|NCT00355875|"     Hypothesis: In this feasibility study, hyperoxemia, as approximated by transcutaneous     hemoglobin saturation with oxygen (Sp02), at the time of birth will cause sustained pulmonary     oxidative stress as demonstrated by elevation of pulmonary protein carbonyl. Furthermore,     this oxidative stress will be directly proportional to the imposed oxygen-burden during     resuscitation at the time of birth.      This study will give us information regarding the magnitude of protein carbonyl elevation in     the preterm infant. With these results we will be able to 1. establish the technique for the     running or protein carbonyl assays and 2. calculate an appropriate sample size for a future     randomized control trial.   "
192289|NCT00355888|"     The purpose of this study is to determine whether MBP-426 (liposomal oxaliplatin suspension     for injection) is safe and effective in the treatment of advanced or metastatic solid tumors.   "
192291|NCT00355914|"     1. To demonstrate whether:           i. Facet joint nerve blocks have therapeutic value beyond the duration of local          anesthetic effect.           ii. Adjuvant medications (Sarapin and Depo-steroids) provide additional relief of lumbar          facet joint pain when used with facet joint nerve blocks.        2. To demonstrate whether or not there are clinically significant improvements in function          of patients who receive lumbar facet joint nerve block with or without Sarapin and          Depo-steroids (Group II) compared to patients randomized to Group I who receive only          local anesthetic blocks.        3. To determine the adverse event profile in both groups.   "
192292|NCT00355927|"     The purpose of this study is to detect possible changes in the electrical activity of the     Basal Ganglia related to sedation during deep brain stimulation surgery.   "
192293|NCT00355940|"     The investigators want to test a navigation system for guidance during insertion of stent     graft in abdominal aortic aneurysms. The navigation system consists of software developed by     SINTEF Health, a custom made catheter with a micro position sensor in the tip and an emitter     than induces an electromagnetic field around the patient. Preoperative CT- and intraoperative     DynaCT- data are reconstructed into 3 dimensional images. The 3 dimensional images are loaded     into the navigation system. Then the magnetic field, in which the patient finds himself, is     calibrated with the 3 dimensional images. When the catheter is inserted into the iliac artery     and aorta, the position sensor (in the tip of the catheter) is displayed in real time at the     exact anatomic location in the 3 dimensional image.      Null hypothesis (H0):        -  Insertion of stent graft is performed equally satisfactorily with fluoroscopy alone as          with both fluoroscopy and new navigation technology      Alternative hypothesis (H2):        -  Insertion of stent graft is NOT performed equally satisfactorily with fluoroscopy alone          as with both fluoroscopy and new navigation technology   "
192294|NCT00355953|"     The present research program is proposed deepening some pharmacological effects of the     genistein therapy in order to individualize alternative treatments to the conventional     hormonal replacement therapy useful to reduce the cardiovascular morbidity and mortality and     the osteoporotic consequences in postmenopausal women.   "
192295|NCT00355966|"     Induction of labour with vaginal misoprostol, in women with premature rupture of membranes at     term, results in significant shortening of induction to delivery time in comparison to     vaginal PGE2 gel induction.   "
192296|NCT00355979|"     To evaluate and compare the effectiveness of intragastric balloon and Sibutramine (Reductil®)     in the treating of non-morbid obese in a randomized controlled manner   "
192297|NCT00355992|"     The purpose of the study is to evaluate the utility of Ischemia Modified Albumin (IMA) for     risk stratification in patients presenting with chest discomfort and possible ischemic heart     disease, and to evaluate the diagnostic and prognostic implication for IMA for major adverse     cardiac events.   "
192298|NCT00356005|"     The purpose of this study is to investigate the efficacy of azithromycin combination therapy     with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.   "
192299|NCT00356018|"     To determine, in a randomized, parallel open-label fashion, compliance rates between     once-daily extended-release divalproex sodium tablets (Depakote-ER®, Abbott Labs) versus     multiple-daily dose valproic acid capsules (Depakene®, Abbott Labs) in an epilepsy     population.   "
192300|NCT00356031|"     The main purpose of this study is to test the effectiveness of bevacizumab in combination     with radiation therapy to see what effects (good or bad) they have on patients with soft     tissue sarcoma. Bevacizumab is an antibody designed specifically to slow or stop the growth     of cancerous tumors by decreasing the blood supply to the tumor. Bevacizumab is approved by     the FDA in combination with intravenous 5-fluorouracil-based chemotherapy as a treatment for     patients with cancer of the colon or rectum that has spread. However, the use of bevacizumab     in combination with radiation for sarcomas is still under investigation.   "
192301|NCT00356044|"     The aim of this study is to compare the radial and femoral access for percutaneous     interventions in the acute phase of the ST elevation acute myocardial infarction in terms of     efficacy and security.   "
192302|NCT00356057|"     The purpose of this study is to demonstrate the safety and effectiveness of biventricular     pacing over conventional right ventricular pacing in patients with persistent or permanent,     symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent     pacing therapy.   "
192303|NCT00356070|"     The treatment of ADHD in jail will help the prisoners in their rehabilitation process   "
192304|NCT00356083|"     Patients with non-malignant pain are switched from morphine to methadone with a nine-months'     follow-up.   "
192305|NCT00356096|"     The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to     0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and     depressive symptoms, after 12 weeks of treatment   "
192409|NCT00365690|"     This study will evaluate the effectiveness of a telephone-delivered coping improvement group     intervention in improving quality of life in older adults with HIV.   "
192410|NCT00365703|"     The purpose of this study is to find out which method (nasogastric vs. orogastric) of feeding     tube for premature infants results in earlier only oral feeding.   "
192306|NCT00356109|"     A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin     Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable     insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with     type 1 diabetes mellitus.      This study is designed also to examine insulin antibody levels in AIR Insulin -treated     patients compared with injectable insulin-treated patients with type 1 diabetes.      The present study is intended to determine if preprandial AIR Insulin is non-inferior to     preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from     baseline to endpoint at 6 months in patients with type 1 diabetes.   "
192307|NCT00356122|"     The purpose of this study was to see how well three investigational drugs worked together in     preventing progression of the disease. This study provided a new combination of chemotherapy     drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer.     The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor     and may also prevent tumor growth. The three investigational drugs are United States Food and     Drug Administration (FDA) approved.   "
192310|NCT00356161|"     Procedures to provide interventional implantation of a port catheter system into the hepatic     artery and adjacent regional chemotherapy of the liver are optimized in the scope of an open,     single-arm trial in patients with metastases and cancers confined to the liver. The primary     objective is the improvement of indication, implantation procedure, and regional     chemotherapy. Secondary objectives are port patency, comparison of complications with a     historical collective of patients provided with a surgical hepatic arterial port device     (colorectal cancer patients only), progression free and overall survival, efficacy of     maintaining regional chemotherapy with 5-FU in combination with systemic treatment in     patients with extrahepatic progression, quality of life.   "
192311|NCT00356174|"     The purpose of this study is to observe the natural course of food allergy, including both     the development of peanut allergy in infants at high risk for developing this allergy, and     the resolution of both egg and cow's milk allergy.   "
192312|NCT00356187|"     Critically injured patients endure a period of hypermetabolism/catabolism after being     resuscitated. The metabolic cost of this may be measured in loss of lean body mass, poor     wound healing, susceptibility to infection and long hospital stays. While there have been     some data to suggest that hypermetabolism can be ameliorated in burn patients by beta     blockade, to our knowledge, a prospective trial in trauma patients has not yet been done. Our     hypothesis is that nonselective beta blockade will reduce catabolism, improve glucose     control, blunt loss of lean body mass, decrease infections and improve outcome in a cohort of     critically injured patients.   "
192313|NCT00356200|"     We are doing this research study to evaluate the effectiveness and safety of fluphenazine     decanoate when injected with a needle into psoriasis lesions in adults. Fluphenazine     decanoate is FDA (U.S. Food and Drug Administration) approved for use in people who have     schizophrenia and psychotic symptoms. Fluphenazine decanoate is not approved by the FDA for     use in psoriasis. Fluphenazine decanoate slows T cell growth in cells in laboratory test     tubes. Its usefulness and safety in people with psoriasis will be investigated in this study.   "
192314|NCT00356213|"     The laparoscopic sleeve-gastrectomy (SG) compared to laparoscopic proximal Roux-Y-gastric     bypass (PGB) is as successful in the treatment of morbid obesity in the majority of patients.     In case of insufficient weight loss malabsorption can to be added by performing laparoscopic     bilious-pancreatic diversion duodenal switch (BPD). The resection of the gastric fundus (LG)     leads to changes in gastrointestinal hormones that are possibly different to bypassing the     fundus (PGB).   "
192315|NCT00356226|"     To examine the effects of the addition of clonidine to diuretics on the mobilization of     ascites at short-term (diuretic response and requirement of diuretics) and long-term     (readmissions for tense ascites and requirement of diuretics) in cirrhotics with increased     sympathetic nervous system. Secondary objectives were to study neuro-hormonal,hemodynamic     effects and side effects of clonidine and diuretics.   "
192316|NCT00356239|"     To evaluate short-term and long-term effects by MR imaging on the technical and functional     status of implantable cardioverter defibrillators.   "
192317|NCT00356252|"     This study will examine the the efficiency fo absorption of major plant pigments,     carotenoids, (lutein, beta-carotene and lycopene)and will measure the biological functions of     carotenoids in healthy women in response to an 8-week period of carotenoid supplementation.      The antioxidant capacity (in both the aqueous and lipid compartments), DNA oxidation (single     cell gel electrophoresis), Insulin-like Growth Factor (IGF-1), Insulin-like Growth Factor     Binding Protein-3 (IGFBP-3), (gene expression profile (high-density filter-based cDNA     microarrays), lipid peroxidation (MDA analysis and Isoprostane determination), and     antioxidant nutrient levels (carotenoids, tocopherols, ascorbic acid and uric acid) in the     circulation will be measured every other week throughout the study period.   "
192373|NCT00357045|"     Objectives:        1. To determine whether paroxetine can prevent major depression in patients with hepatitis          C (HCV) who are receiving pegylated-interferon (Peg-IFN).        2. To determine whether paroxetine can prevent subsyndromal increases in depression and          anxiety in patients with HCV who are receiving Peg-IFN.        3. To determine whether paroxetine can prevent a significant change in the health related          quality of life in patients with HCV who are receiving Peg-IFN.        4. To determine whether paroxetine improves compliance with Peg-IFN therapy for HCV.        5. To determine whether paroxetine enables patients to complete Peg-IFN therapy for HCV who          might otherwise require a dose reduction or discontinuation because of neuropsychiatric          side effects.   "
192319|NCT00356278|"     This study will determine whether a combination of virtual reality exposure therapy and     D-cycloserine will reduce post-traumatic stress disorder symptoms in Iraq war veterans.   "
192320|NCT00356291|"     This study will evaluate the effectiveness of motivational interviewing plus skill building     in reducing HIV risk behavior in people with serious mental illnesses.   "
192321|NCT00356304|"     This study will determine the effectiveness of motivational interviewing in improving     antidepressant medication adherence among Hispanics.   "
192322|NCT00356317|"     This study will evaluate the effectiveness of a culturally based family therapy intervention     in improving treatment outcome in people with schizophrenia.   "
192323|NCT00356330|"     To evaluate short-term and long-term effects by MR imaging at 3T on the technical and     functional status of cardiac pacemakers.   "
192324|NCT00356343|"     The purpose of this study is to determine if using high-intensity, short-duration,     intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise     in increasing quadriceps femoris and triceps surae force-generating potential and gross motor     function in children with cerebral palsy.   "
192325|NCT00356356|"     The purpose of this study was to evaluate extended safety and efficacy of etanercept in     adults with Ankylosing Spondylitis.   "
192342|NCT00356616|"     To evaluate whether the combined therapy of two nucleosides plus one nucleotide (Trizivir +     TDF) manages to keep CD4 lymphocytes stable in patients with HIV infection on antiretroviral     treatment that present virological failure and multiple resistance to antiretrovirals.   "
192343|NCT00356629|"     The aim of the study is identify biological parameters reflecting proteolytic activity in the     exhaled condenstaes which might be useful to follow up pulmonary inflammation in various     conditions including cystic fibrosis, COPD, asthma, tobacco exposure. Three proteases will be     analyzed, i.e. elastase, proteinase 3 and cathepsin G. Results in the condensates will be     compared to those obtained in sputum.   "
192326|NCT00356369|"     Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y.     Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell     dependant immune response while the existing polysaccharide vaccines induce a T-cell     independent response, i.e. with no immune memory response. GSK Biologicals has developed a     combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to     serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT     conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as     control. In the long-term follow-up phase (extension phase) of the study, the long-term     protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years     after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This     protocol posting deals with objectives & outcome measures of both the primary & extension     phases.   "
192327|NCT00356382|"     The purpose of this study is to determine the effectiveness of a cultured dairy drink with     high concentrations of active L casei to reduce the cumulative rate of illness in     daycare/school children ages 3 to 6.   "
192328|NCT00356395|"     we hypothesized that combination therapy has additive beneficial effects to improve     endothelial dysfunction and adipocytokine profiles in patients with hypertension.   "
192329|NCT00356408|"     This is an open-label extension study designed to measure the safety, efficacy, and     corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to     severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).   "
192330|NCT00356421|"     To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes     mellitus   "
192331|NCT00356434|"     The researchers at Johns Hopkins University believe that the foot pump will be superior to     sequential compression devices in comfort and patient compliance which may increase provider     efforts to prevent deep vein thrombosis (DVT) in pregnancy.   "
192332|NCT00356447|"     The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and     estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor     symptoms) and uro-genital complaints.   "
192333|NCT00356460|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics of GC1008, a human anti-transforming growth factor-beta (TGFβ) monoclonal     antibody in previously treated patients with locally advanced or metastatic renal cell     carcinoma or malignant melanoma.   "
192334|NCT00356473|"     This research evaluates the effects of a cholesterol-lowering medication, atorvastatin, on     both arthritis activity and the ability of high-density lipoprotein cholesterol (HDL-C,     sometimes referred to as good cholesterol) to prevent changes in low-density lipoprotein     cholesterol (LDL-C, sometimes referred to as bad cholesterol), which lead to     atherosclerosis, or hardening of the arteries. We hypothesize that atorvastatin may improve     both joint inflammation and the anti-inflammatory properties of HDL cholesterol.   "
192335|NCT00356486|"     The purpose of this study is to compare the early virological response (EVR = undetectable     [ribonucleic acid-hepatitis C virus] RNA-HCV or a reduction of > 2 log10) of patients with     chronic hepatitis C coinfected with HIV treated with induction doses of peginterferon     alpha-2a (40 KD) 270 µg/week and ribavirin 1600 mg/day for 4 weeks, followed by 8 weeks of     treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day     versus treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200     mg/day for 12 weeks.   "
192427|NCT00365924|"     This methodology trial will be conducted in patients with osteoporosis and will measure the     changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone     density following therapy with the approved drug, Forteo.   "
192336|NCT00356512|"     This study will explore the regulation of fibroblast growth factor-23 (FGF-23). It is a     hormone recently identified as a regulator of the blood levels of phosphorus and vitamin D,     both of which are essential for overall health and especially important for bone health. The     parathyroid hormone (PTH) regulates phosphorus and calcium, but people with     hypoparathyroidism or pseudohypoparathyroidism do not have sufficient PTH action. There are     genetic diseases that influence FGF-23, causing abnormal metabolism of phosphorus and vitamin     D, thus affecting the bones. Also, there are rare tumors that may cause overproduction of     FGF-23 causing debilitating bone disease.      Patients ages 18 and older who have low PTH levels, or are resistant to PTH action, and take     calcitriol and calcium supplements, who are not pregnant, and who do not have kidney     disorders may be eligible for this study. During the 4-day study, patients will be provided     with a controlled diet that has a lower than usual phosphorus content. On day 1, patients     will be admitted to the NIH Clinic Center and undergo blood and urine tests to measure     calcium, phosphorus, vitamin D, and FGF-23. They will continue with their regular medicine     for hypoparathyroidism. On that day and throughout the study, patients will fast from 10:00     p.m. to 8:00 a.m. the following day. On day 2, patients will continue fasting until 4:00 p.m.     A tube will be placed in the vein of each arm: one for drawing blood and the other for     infusing calcium. Just one intravenous (IV) line will be used on the other days. Patients     will receive calcium chloride for 8 hours, at a dose carefully monitored by a machine. The     purpose is to bring the blood calcium level to the high normal range or just above. Blood and     urine samples will be collected periodically, to check for effects of calcium chloride on     FGF-23 and PTH. On days 3 and 4, patients will not take calcitriol and calcium but will     receive injections of PTH, under the skin, two times each day. On day 3, blood and urine     samples will be again be collected for analysis. On day 4, patients will receive one dose of     calcitriol by IV. The total amount of blood drawn during this study will be about 5 ounces.   "
192337|NCT00356525|"     The purpose of this study is to help answer:        -  Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s)          disappear in patients with relapsed lung cancer (lung cancer that has come back after          surgical removal and chemotherapy), and to determine how long this will last        -  Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung          cancer live longer   "
192338|NCT00356551|"     The goals of this study are to evaluate the effects of an in-home parenting education     program, called Family Spirit, on parenting knowledge and skills and decreasing alcohol and     substance use compared to a breast-feeding education. In addition, we will assess aspects of     mother/child interaction.   "
192339|NCT00356564|"     Persistence of seroprotective antibody concentrations & immunological memory shown by the     ability to mount a response to a challenge dose of HBV vaccine   "
192340|NCT00356590|"     This is an open label, multicenter study for extended treatment of patients who have     participated in the Immunex clinical study 016.0012. The primary objective of this study is     to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage     rheumatoid arthritis.   "
192341|NCT00356603|"     This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg     kit product for the treatment of migraine or cluster headache attacks in clinical settings,     to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness)     and rate of successful self-injection.   "
192345|NCT00356655|"     This a comparative study of enhanced pharmacist care and regular care of patients starting on     antidepressants. When providing participants with enhanced care pharmacists will use the     Health Professional's Antidepressant Communications Tool (Health PACT) a minimum of three     times during face-to-face discussions. This tool was developed specifically for this study.     All participants will be followed for 26 weeks and will be assessed for duration of use of     their antidepressant, adherence to treatment, and clinical response.   "
192346|NCT00356668|"     The specific aims of this study are to evaluate the amount of high flow nasal cannula (HFNC)     gas flow required to generate an equivalent positive distending pressure as that provided by     nasal continuous positive airway pressure (NCPAP) of 6 cm H2O, assess the relationships     between positive distending pressure, gas flow, oxygen requirement, and patient weight, and     lastly, develop an appropriate protocol to be used in the NICU for transitioning patients     from NCPAP to an equivalent amount of HFNC.   "
192347|NCT00356681|"     To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706     placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to     estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus     bevacizumab.   "
192348|NCT00356707|"     African American women have higher rates of obesity than women of any other racial or ethnic     group in the United States. Obesity can have many causes, including genetic and environmental     factors. This study will examine how neighborhood environments influence the occurrence of     obesity among African American women.   "
192349|NCT00356720|"     To assess in children the efficacy and safety of 2 dosing regimens of T1225 1.5% eye drops,     in comparison to a reference product, single-dose oral azithromycin (AZM) 20 mg/kg, for the     treatment of active trachoma. Evaluation of clinical efficacy was primary (% of clinical cure     at Day 60 in Per Protocol Set), microbiological evaluation was secondary   "
192388|NCT00364481|"     Tongue exercises are described to improved snoring and acid reflux symptoms. Acid reflux     treatment has been found to improve obstructive sleep apnea to a limited degree. Upper airway     resistance syndrome is caused by resistance to breathing, leading to multiple respiratory     event related arousals, leading to daytime fatigue and other various physical ailments.     Tongue base or retrolingual collapse is implicated in upper airway resistance syndrome. We     will measure sleep quality and quality of life indices before and after treatment for     subjects that undergo tongue exercises only, acid reflux treatment only, and those that     undergo both treatments.   "
192411|NCT00365716|"     This study was conducted in 2 parts. Part A was a randomized, double-blind,     placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a     randomized, double-blind (operating under in-house blinding procedures), placebo-controlled,     multicenter, dose-ranging study.   "
192350|NCT00356733|"     Erythropoietin (EPO) treatment in patients with the severe cardiorenal syndrome increases     cardiac performance and decreases progression of renal failure by dampening the main driving     forces of the cardiorenal syndrome in part via non-erythropoietic pathways.      I. Does EPO administration to patients with the severe cardiorenal syndrome increase cardiac     performance and decrease progression of renal disease?      II. Does EPO treatment affect the main driving forces of the cardiorenal connection, that is,     dampen the activated renin-angiotensin system (RAS), attenuate increased reactive oxygen     species (ROS), normalize increased sympathetic activity, and decrease inflammation?      III. Does EPO treatment positively affect the cell function of patients with the cardiorenal     syndrome:        1. are gene expression signatures of leukocytes positively influenced by EPO treatment,        2. does EPO shift the Jak/STAT pathway to a less pro-inflammatory profile in monocytes, and        3. are function and number of endothelial progenitor cells (EPCs) affected by treatment          with EPO in the cardiorenal syndrome?      IV. Can the direct actions of EPO be differentiated from the effects on hemoglobin levels?   "
192351|NCT00356746|"     The purpose of this study is to investigate the effects of total intravenous anesthesia     versus volatile anesthesia on the perioperative inflammatory response during and after major     surgery.   "
192352|NCT00356759|"     Patients with mechanical heart valve prosthesis or with irregular beat (atrial fibrillation)     have a high risk of blood clot formation. Such clots can result in a stroke. The patients are     treated with warfarin - a blood thinner - to prevent these complications. The treatment has     to be monitored with a blood test called Prothrombin time (PT) every 1-4 weeks. The dose of     warfarin has to be changed whenever the PT result is outside of the treatment range. If the     result is too low there is an increased risk of blood clots. If, instead, the result is too     high there is a risk of bleeding. One third of the patients have very stable PT results and     hardly ever have to change the dose.      The investigators hypothesis is that these patients can go less often, e.g. every 12 weeks,     for the blood tests.   "
192353|NCT00356772|"     To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment     initiation.      To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7   "
192354|NCT00356785|"     Eligible overweight and obese persons will be randomized to one of three controlled groups: 1     group of participants is treated by health education for life style intervention only. The     other 2 groups will be included in a dietary program with an individually dosed food     supplement (Almased®) for an initial weight reduction for a period of 6 weeks. The following     18 weeks represent the most important phase of weight loss and attitude, the participants     take part in 2 different interventions according to their randomization. One group will     continue the dietary program, one group will try to achieve and maintain weight reduction by     continuing the initial dietary program together with an additional physical activity program.     For all intervention groups the following 6 months aim at a further stabilization of weight     and attitude, now without defined guidelines of intervention but with the intention to     continue the so far practiced change in life style. All participants will be supplied with     adequate information and material concerning the desired change in life style.   "
192355|NCT00356798|"     Based on pre-clinical trial data and principle of GCP, the objective of phase I clinical     trial is to evaluate safety and immunogenicity of Pan-flu vaccine, an inactivated whole     virion H5N1 vaccine with aluminium hydroxide adjuvant.   "
192356|NCT00356811|"     This study investigates the safety and efficacy of oral lapatinib in combination with an     approved medication, paclitaxel, for patients with ErbB2 metastatic breast cancer.   "
192357|NCT00356824|"     HIV and malaria are two of the most important diseases to afflict children in sub-Saharan     Africa. However, it is unknown what relationships exist between the two diseases. The purpose     of this study is to determine the relationship between HIV and malaria infections in HIV     infected Ugandan children.   "
192358|NCT00356837|"     The purpose of this study is to determine the efficacy of ultrasound in diagnosing the     presence or absence of extremity fractures or dislocations.      Hypothesis: Can ultrasound be used as an accurate and effective method for determining the     presence or absence of extremity fractures or dislocations? Is there a difference in amount     of pain experienced prior to and after the ultrasound?   "
192359|NCT00356850|"     To evaluate azithromycin tear concentrations after instillation of one drop of one of the     three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.   "
192360|NCT00356863|"     The main aim of the study is to determine the effectiveness of an educational intervention     designed to increase attendance of coronary artery bypass grafting (CABG) patients at Cardiac     Rehabilitation Programs (CRPs) on actual CRP participation rate and; examine patient-related     factors (demographic, health, psychosocial, awareness) influencing patients' attendance at     CRPs. We hypothesized that the proportion of CABG patients participating in CRPs will     increase significantly to 20-30% following the educational intervention employed.   "
192361|NCT00356889|"     This phase II trial is studying how well giving bevacizumab together with erlotinib     hydrochloride works in treating patients with metastatic or unresectable biliary tumors.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Erlotinib hydrochloride may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and     erlotinib hydrochloride may also stop the growth of tumor cells by blocking blood flow to the     tumor. Giving bevacizumab together with erlotinib hydrochloride may kill more tumor cells.   "
192389|NCT00364494|"     An hematocrit of 21-25% is supposed to perform the best organ protection during     cardiopulmonary bypass for cardiac surgery.      The investigators want to establish the best timing for a transfusion (in patients with a     predicted low hematocrit during cardiopulmonary bypass) and the efficacy of preprocedural     hemodilution (in patients with a predicted high hematocrit during cardiopulmonary bypass) in     patients undergoing cardiac surgery.   "
192390|NCT00364507|"     this study will try to determine whether serum levels of insulin like growth factor are     higher in fertile women than infertile women.   "
192391|NCT00364520|"     The purpose of this study is to investigate the health effects of benzene exposure in workers     in Shanghai, China.   "
192362|NCT00356902|"     Preterm infants are born with immature lungs and often require help with breathing shortly     after birth. This currently involves administering 100% oxygen. Unfortunately, delivery of     high oxygen concentrations leads to the production of free radicals that can injure many     organ systems. Term and near-term newborns deprived of oxygen during or prior to birth     respond as well or better to resuscitation with room air (21% oxygen) compared to 100%     oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm     infants with lung disease. Our study will investigate how adjusting the amount of oxygen     given to sick preterm newborns will affect the ability to maintain a safe oxygen level in     their blood. Each infant will be assigned to receive one of three treatments at birth.     Resuscitation will either start with 21% oxygen and be increased if needed, 100% oxygen and     be decreased if needed or 100% oxygen with no changes made (current standard of treatment).     The first two groups will have adjustments in oxygen concentration as needed to reach a safe     target range of blood oxygen saturation. We anticipate that preterm newborn infants     resuscitated with higher oxygen concentrations will have higher than normal levels of     oxygen in their blood while those resuscitated initially with lower concentrations of oxygen     will be more likely to have normal oxygen levels in their blood. All premature infants will     have a surface probe placed on the right hand to measure the saturation of blood with oxygen.     Following the resuscitation, treatment will proceed as per standard of care until hospital     discharge. All infants will be admitted to the neonatal intensive care unit given their     prematurity. The purpose of this study is to investigate how safely restricting the amount of     oxygen delivered to newborns during resuscitation will affect the amount of oxygen in their     blood.      Hypothesis: In this randomized control trial, infants resuscitated with a low oxygen     delivery (LOD) strategy (initiation of resuscitation with 21% O2) will remain normoxemic for     the greatest proportion of time during resuscitation and infants resuscitated with a high     oxygen delivery (HOD) strategy (100% O2 used for the entire resuscitation) will be     normoxemic for the smallest proportion of time during resuscitation.   "
192363|NCT00356915|"     Onychomycosis is a common condition accounting for approximately half of all nail disorders.     It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment     of onychomycosis in the United States with an approved dosage regimen for the treatment of     onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100     mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be     used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare     the efficacy and safety of this new tablet formulation with itraconazole capsules and     placebo.   "
192364|NCT00356928|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to     stop the growth of abnormal blood cells, either by killing the cells or by stopping them from     dividing. Giving cyclophosphamide together with donor lymphocytes that have been treated in     the laboratory may be an effective treatment for myelodysplastic syndromes or     myeloproliferative disorders.      PURPOSE: This clinical trial is studying the best dose of donor lymphocytes when given     together with cyclophosphamide in treating patients with myelodysplastic syndromes or     myeloproliferative disorders.   "
192365|NCT00356941|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin and     docetaxel may make tumor cells more sensitive to radiation therapy. Giving oxaliplatin and     docetaxel together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin when     given together with docetaxel and radiation therapy in treating patients with unresectable     stage II or stage III or recurrent non-small cell lung cancer .   "
192366|NCT00356954|"     The contrast induced nephropathy (CIN) has been known to be associated with significant     clinical and economic consequences. Many studies were performed to find the pathophysiology     and preventive measures for CIN. But the results were somewhat frustrating. Recently, it has     been reported that the N-acetylcysteine and ascorbic acid might have preventive effects for     CIN by their antioxidant effects.There have been no study to compare these two antioxidant.   "
192367|NCT00356967|"     The primary objective is to demonstrate the efficacy of dianicline as an aid to smoking     cessation in cigarette smokers. The main secondary objectives are: to assess the craving for     cigarettes, nicotine withdrawal symptoms and the safety of dianicline.   "
192368|NCT00356980|"     RATIONALE: Biological therapies, such as TNF-bound colloidal gold, may stimulate the immune     system in different ways and stop tumor cells from growing.      PURPOSE: This phase I trial is studying the side effects and best dose of TNF-bound colloidal     gold in treating patients with advanced solid tumors.   "
192369|NCT00356993|"     20% of Ontarians smoke. There was a decline in smoking prevalence from 1995 but it has     remained unchanged since 2002. This rate of smoking cessation has not kept up with the rest     of Canada. A new strategy is necessary to increase the number of smokers making quit attempts     and to increase the odds of quitting long term.The goal of this study is to evaluate the     methods and effectiveness of providing nicotine replacement (NRT) to Ontario smokers. The     study will develop an evidence-based protocol for providing NRT, provide faculty development     on combining pharmacotherapy with behavioural interventions and will provide an evaluation     framework to inform future coverage models.   "
192370|NCT00357006|"     OBJECTIVE:      To test the use of adjunctive estrogen in a 8 week, three-arm, double-blind,     placebo-controlled study in the treatment of psychotic symptoms in women with schizophrenia.      HYPOTHESIS:      That women receiving adjunctive estrogen will demonstrate significantly greater improvements     in the symptoms of schizophrenia than women receiving adjunctive placebo.      STUDY POPULATION:      180 women will be recruited over a three-year period across three sites. Participant will be     of potential child-bearing age (Pre-menopausal and Post-menarche) with a current diagnosis of     Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic     phase)according to the Mini International Neuropsychiatric Interview (MINI).      STUDY MEDICATION:      Estradiol. One third of the participants (n=60) will be randomised to receive adjunctive     100mcg Estradiol; one third of the participants (n=60) will be randomised to receive     adjunctive 200mcg Estradiol n=60; and, one third of the participants (n=60) will be     randomised to receive adjunctive placebo n=60). All patches will be covered with identical     adhesive contact to ensure the blind is maintained.      STUDY EVALUATIONS:      Data will be collected over a two-month period for each participant. Visits will be performed     at baseline, and then at weekly or fortnightly intervals. A total of six visits will be     completed for each participant. The following evaluations will be performed:      i) Inclusion/exclusion checklist. (Baseline visit only)      ii) Informed consent. (Baseline visit only)      iii)psychiatric evaluation to determine diagnosis. (Baseline visit only)      iv) General clinical evaluation including medical history, current conditions and a     non-invasive physical examination, body weight, vital signs. (Baseline and endpoint visits)      v) Medication history. (Baseline and evaluation visits)      vi) Demographics. (Baseline visits only)      vii) The primary outcome measures will be the Positive and Negative Syndrome Scale (PANSS),     which will be taken at weeks 1, 2, 4 and 8 of the trial. Cognitive testing will take place at     baseline and 8 weeks. Side effects will be assessed at weeks 1, 2, 4, 6, and 8 to measure     changes in subject's reported side effects during the trial.      viii) Laboratory tests including; Serum levels of mood stabiliser, LH, FSH, Estrogen,     Progesterone, Prolactin, DHEA,Testosterone and(Baseline and evaluation visits).   "
192371|NCT00357019|"     To assess the clinical and biological efficacity of preservative free NAAGA eyes drops in     vernal keratoconjunctivitis   "
192372|NCT00357032|"     This phase II trial is studying how well PXD101 works in treating patients with relapsed or     refractory acute myeloid leukemia or older patients with newly diagnosed acute myeloid     leukemia. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the cancer.   "
192425|NCT00365898|"     The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone     Hydrochloride Extended-Release.   "
192374|NCT00357058|"     This study will examine the role of different brain regions in tactile (touch) ability after     application of a tourniquet (inflated blood pressure cuff). When the forearm is deprived of     blood for a short period of time, tactile ability in the other hand improves. This study will     try to learn what causes this improvement.      Healthy normal volunteers are eligible for this study. Candidates will have a brief medical     history and physical examination.      Volunteers will undergo two experiments, described below, that involve the following     procedures:        -  Ischemic nerve block - A blood pressure cuff is inflated for 35-40 minutes around the          elbow area (also around the calf for Experiment 2 - see below). The resulting numbness,          tingling, loss of muscle strength, and discoloration of the forearm and hand disappear          within minutes after the cuff is deflated.        -  Magnetic resonance imaging (MRI) - This test uses a magnetic field and radio waves          instead of X-rays to produce images of brain structure and function. The volunteer lies          on a stretcher that is moved into the scanner (a cylinder containing a strong magnet),          wearing earplugs to protect the ears from loud thumping noises that occur with          electrical switching of radio frequency circuits. The subject can communicate with an          investigator by intercom at all times during the scan.        -  Transcranial magnetic stimulation (TMS) - An insulated wire coil is placed on the          patient's scalp. A brief electrical current passes through the coil, creating a magnetic          pulse that travels through the scalp and skull and causes small electrical currents in          the outer part of the brain. The stimulation may cause muscle hand or arm twitching or          transient tingling in the forearm, head or face muscles.        -  Tactile spatial acuity testing - The subject's left arm is placed in a cast and the left          index finger is immobilized for this test which involves identifying the direction of          grooves applied to the finger.      Experiment 1      This experiment measures changes in tactile acuity and brain activation following cuff     inflation. The subject lies in the MRI scanner, with the left arm immobilized. Tactile acuity     is measured repetitively at the left index finger during placement and inflation of a     pressure cuff around the right forearm. The experiment consists of two sessions with the cuff     around the forearm and one with the cuff around the calf and lasts from 90 minutes to 2     hours.      Experiment 2      This experiment measures changes in tactile acuity linked to TMS stimulation. The subject     sits in an armchair with the left arm immobilized. Tactile acuity is measured repetitively at     the left index finger during placement and inflation of a pressure cuff around the right     forearm. In addition, TMS pulses (about one pulse per second) are delivered at different     locations over the right side of the head for up to 30 minutes. The experiment consists of 10     separate sessions on different days, each lasting about 1 hour.   "
192375|NCT00357071|"     This study will collect blood samples from patients with non-infectious eye inflammatory     diseases a spectrum of eye disorders that can produce sight-threatening vision loss. The     blood will be analyzed for substances that may provide a better understanding of the nature     of these disorders, possibly leading to improved treatments. Treatment is not offered under     this protocol.      Patients 6 years of age and older with an eye inflammatory disease, including non-infectious     uveitis, ocular cicatricial pemphigoid, non-infectious scleritis, episcleritis, Stevens     Johnson syndrome, Moorens ulcer, peripheral ulcerative keratitis and keratoconjunctivitis     sicca, may be eligible for this study. Patients may or may not currently be participating in     a treatment trial.      Participants will have blood drawn through a needle in an arm vein. More samples may be     collected if patients enrolled in another study are scheduled for additional visits. No more     than 4 teaspoonfuls of blood will be collected at any one time.   "
192376|NCT00357084|"     RATIONALE: Methotrexate and glucocorticoid therapy, such as prednisone or methylprednisolone,     may be an effective treatment for acute graft-versus-host disease caused by a donor stem cell     transplant.      PURPOSE: This phase II trial is studying how well giving methotrexate together with     glucocorticoids works in treating patients with newly diagnosed acute graft-versus-host     disease after donor stem cell transplant.   "
192377|NCT00357097|"     Ropinirole has shown to improve mood in depressed patients as well as to improve the symptoms     of Restless Legs Syndrome. Up to 40% of RLS patients suffer from mild depression, therefore     it would be important for decisions no therapy to know whether a drug could improve both     depressive and RLS symptoms.   "
192378|NCT00364351|"     To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung     Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy,     Erlotinib   "
192439|NCT00366093|"     To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or     menopause following treatment with 3 mg of eszopiclone.   "
192379|NCT00364364|"     This no treatment research study is being done to find a safe and an appropriate dose of     antibody (protein) against tumor cells to best target the cancer in people with pancreatic     cancer. To do this, this no-treatment research study will compare two doses of an antibody     called hPAM4 IgG when combined with a radioactive element, Indium-111.   "
192380|NCT00364377|"     People with high fasting glucose can develop type 2 diabetes with the passage of time. This     study is being done to determine the effect of a novel medication in people with this     elevated fasting glucose. Sitagliptin is a substance that raises levels of a hormone normally     found in the blood. This hormone, called glucagon-like peptide-1 (GLP-1), is normally     released by the intestine in response to the presence of food. This hormone acts like a     messenger between the intestine and the pancreas to raise insulin levels, and therefore,     lower blood sugars. Sitagliptin is effective in people with diabetes, however, this study is     being done to determine if Sitagliptin is effective in people with high fasting glucose who     do not yet have diabetes.   "
192381|NCT00364390|"     This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular     Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.   "
192382|NCT00364403|"     This study will compare the effects of a low glycemic load versus standard diet for pregnancy     on outcomes related to risk for obesity, diabetes, and heart disease in both mother and     infant.   "
192383|NCT00364416|"     The purpose of this study is to gather information to better understand the characteristics,     medical management techniques and outcomes of patients with chronic severe Heart Failure     (HF).   "
192384|NCT00364429|"     This study was designed to compare the [123]I-CNS 1261 binding to NMDA receptor between     healthy volunteers and different subgroups of schizophrenic patients. Investigation of the     potential influence of antipsychotic and concomitant medication on [123I] CNS 1261 binding is     also relevant.Fifteen healthy subjects (male and female of non-child bearing potential) will     be recruited and 40 schizophrenic patients divided in 3 subgroups as indicated before:     Subgroup a) treatment-naive, (n=10); Subgroup b) on stable treatment with risperidone     (without criteria of deficit syndrome on the SDS scale, (n=15);Subgroup c) on stable     treatment with risperidone fitting criteria of deficit syndrome on the SDS scale, (n=15).   "
192385|NCT00364442|"     A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone     propionate and salmeterol was compared with concurrent administration of fluticasone     propionate and salmeterol. Administration occurred over 14 days and tolerability, PK     (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.   "
192386|NCT00364455|"     The purpose of this study was to evaluate the effect of treatment with epoetin alfa     (recombinant human erythropoietin) or placebo on anemia related quality-of-life and anemia in     hormone-refractory (not responding to hormone therapy) prostate cancer patients.   "
192387|NCT00364468|"     To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with     a single injection of KRN125 or multiple daily injections of filgrastim.   "
192395|NCT00364572|"     Tumor necrosis factor (TNF)-alpha has been strongly implicated as a major contributing factor     for the development of radiculopathy. In animal studies, the application of TNF-alpha to     nerve roots results in pain behavior indicative of radiculopathy. The use of TNF-alpha     inhibitors (etanercept and infliximab) have been shown to prevent this pain behavior.     Open-label studies in humans have shown both etanercept and infliximab provide excellent,     long-term relief in patients with acute radiculopathy from herniated disc. However, a recent     placebo-controlled study failed to demonstrate any significant difference from placebo. The     investigators have already established the safety of neuraxial etanercept in a trial that has     just been completed (not yet published). The objective of this study is to determine whether     small doses of epidural etanercept, an anti-TNF-a medication, is an effective treatment for     LBP caused by nerve root irritation (i.e., radiculopathy).   "
192396|NCT00364585|"     The purpose of this study is to evaluate the performance of the GreenLight™ model 120     delivering higher average power to allow for more flexibility in the working distance of the     delivery device with the same power density to tissue as that of the current GreenLight     model. In addition this study will examine the Laserscope GDD (guided delivery device) that     has been designed exclusively for use with the GreenLight™ model 120.   "
192397|NCT00364598|"     The purpose of this study is to obtain human heart tissue after treatment with Anginera to     determine its effect on a variety of things that might indicate improvement in heart     function. Patients who will have a left ventricular assist device (LVAD) implanted while they     wait for a donated heart will be treated with Anginera. At the time of heart transplant,     their diseased heart which is removed will be analyzed by microscopic examination to see what     effect Anginera had.   "
192398|NCT00364611|"     Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study     designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab     for the first-line treatment of participants with metastatic breast cancer. Participants were     stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of     enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab     (DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and     trastuzumab (DBT).      All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis     and safety analysis was performed using the cut-off date of June 2011. One participant     continued treatment till 11 March 2012. For this participant, adverse events were collected     upto 19 April 2012 and included in the safety analysis.   "
192399|NCT00364624|"     Patients with newly diagnosed lung cancer may have hypofunction of the adrenal cortex either     from tumour metastasis or other mechanisms. Since lung cancer patient may have to undergo     stressful investigation and treatments, undetected hypofunction of the adrenal cortex may be     hazardous. Knowledge of the size of the problem may help determine whether routine check is     warranted.   "
192400|NCT00364637|"     Patients undergoing stenting procedures, or cardiac or non-cardiac surgery could develop     myocardial damage as testified by cardiac troponin release.      Sevoflurane (volatile anesthetic), routinely used in cardiac and non-cardiac anesthesia, has     cardioprotective properties that could be useful to reduce cardiac damage, as indicated by     cardiac troponin release in different contexts:        -  stenting procedures (periprocedural administration)        -  non-cardiac surgery (during the whole procedure)        -  cardiac surgery (during the whole procedure)   "
192402|NCT00364663|"     We plan to conduct a prospective study:        1. to evaluate the accuracy of PET in staging patients with potentially operable non-small          cell lung cancer;        2. to evaluate the percentage of futile thoracotomy after PET is introduced in the routine          staging modalities for NSCLC patient;        3. to establish a decision tree model based on choices between conventional imaging only          and additional PET imaging to analyze their cost-effectiveness.   "
192403|NCT00364676|"     This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of     vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's     lymphoma, or Hodgkin's disease.   "
192404|NCT00365612|"     To compare the effectiveness (efficacy, safety & tolerability) of a Single Tablet Regimen of     efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured     by the proportion of patients who maintain viral load (HIV-1 RNA) <200 copies/mL at Week 48.   "
192405|NCT00365625|"     The stepwise process of leukocyte extravasation to inflamed tissues depends on the expression     of a variety of cytokines and adhesion molecules. Recently much attention has focused on the     Junctional Adhesion Molecules (JAM). The three members of this adhesion molecule family,     namely, JAM-A, -B and -C, have been shown to govern the last step of leukocyte extravasation     (transmigration) - the process of leukocytes passing between endothelial cells. In addition     to transmigration, some members of this family seem to support additional steps in the     leukocyte extravasation cascade. The investigators recently showed, that antibody-mediated     inhibition of JAM-C significantly reduced hapten induced skin inflammation (J Invest     Dermatol;125(5):969).      Recent unpublished work from our laboratory showed, that JAM-C expression of lymphocytes can     be up-regulated through specific activators. Hence, the investigators hypothesize, that JAM-C     expression is elevated in patients with psoriasis. As it is currently not know, which factors     may influence the expression of JAM-C, the investigators intend to analyse JAM-C expression     on CD3+CD41- cells at several time-points during the treatment of psoriatic patients.     Expression of JAM-C will then be correlated to disease activity (PASI).   "
192406|NCT00365638|"     The purpose of this study is to determine whether statins (simvastatin) improve clinical     (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of     systemic inflammation) in women with polycystic ovary syndrome (PCOS).   "
192407|NCT00365651|"     This study will examine whether two months of youth soccer, combined with a single brief     behavioral/nutritional intervention, can reduce BMI in 5th grade overweight or obese females.   "
192408|NCT00365677|"     The objective of this study was to compare the safety and effectiveness of two versions of     the Bausch & Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue     Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment.   "
192412|NCT00365729|"     Human papillomavirus (HPV)-infection belongs to the most common sexually transmitted diseases     worldwide. HIV-infected men having sex with men (MSM) are strongly associated with a higher     prevalence of genital HPV-infection, a higher incidence of anal intraepithelial neoplasia     (AIN), and, consecutively, an increased risk for anal cancer. Since the introduction of     highly active antiretroviral therapy (HAART), the incidence of several viral-associated     neoplasias has significantly fallen in HIV-infected individuals. At the beginning of the era     of HAART, a justified hope existed that genitoanal HPV-related neoplasias would also decrease     based on the success of HAART-induced immune restoration. However, HAART seems to have only a     small impact on the natural history of AIN as observed in a cohort of HIV-positive MSM before     and after the initiation of HAART.      As AIN and cancer precursor lesions of the cervix, cervical intraepithelial neoplasia, share     distinct clinical similarities, cytologic smear testing for AIN has been recommended to     detect and treat early lesions. Thus, this prospective study mainly focuses on the predictive     value of HPV-DNA load for the development and clinical progression of AIN in HIV-infected     MSM. Moreover, the course of HPV viral load under therapy for anal intraepithelial neoplasia,     e.g. topical treatment with imiquimod, will be evaluated. Additionally, immunohistochemical     determination of several proliferative biomarkers, as well as cytokines, will be performed.   "
192413|NCT00365742|"     Randomized trial in a primary prevention population        -  all participants have high LDL cholesterol      Group one will take simvastatin 40 mg/day Group Two will make therapeutic lifestyle     changes,and take supplements consisting of red yeast rice and fish oil   "
192414|NCT00365755|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs     to be removed. A bone marrow transplant, using bone marrow from the patient, may be able to     replace blood-forming cells that were destroyed by chemotherapy. It is not yet know which     combination chemotherapy schedule is more effective, when given before surgery and an     autologous bone marrow transplant, in treating patients with disseminated neuroblastoma.      PURPOSE: This randomized phase III trial is studying two different chemotherapy schedules to     compare how well they work in treating young patients who are undergoing surgery and an     autologous bone marrow transplant for disseminated neuroblastoma.   "
192415|NCT00365768|"     RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known     whether glutamine is more effective than a placebo in treating neuropathy caused by     vincristine.      PURPOSE: This randomized phase II trial is studying glutamine to see how well it works     compared to a placebo in treating neuropathy caused by vincristine in young patients with     lymphoma, leukemia, or solid tumors.   "
192416|NCT00365781|"     10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS     113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a     5-minute period. On Study Days 2 and 8, each subject's injection sites will be assessed for     dermatologic effects. The Isis Project Physician(s) will observe the injection sites on Study     Day 2 and may also observe on Study Day 8.      Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Day 1     and Day 8. Subjects will be contacted by telephone on Study Day 30 to monitor for the     occurrence of new serious adverse events (SAEs). Thereafter, the subjects will be discharged     from the study.   "
192417|NCT00365794|"     A. HYPOTHESES: In older men low testosterone levels, abdominal obesity and elevated fasting     insulin who are at risk for the cardiovascular complications such as heart attack and stroke.        1. Supplemental testosterone will decrease abdominal fat (visceral adominal adipose tissues          (VAT), subcutaneous abdominal adipose tissue (SAT), and hepatic fat) and          intramyocellular lipid in peripheral muscles(IMCL).        2. Supplemental testosterone will improve insulin sensitivity by:             1. Decreasing hepatic glucose output (HGO), a measure of central insulin resistance             2. Decreasing VAT             3. Decreasing SAT             4. Increasing adiponectin production             5. Improving peripheral glucose disposal (Rd) by reducing IMCL             6. Increasing appendicular skeletal muscle mass and basal metabolic rate      B. OBJECTIVES:        1. Primary Objective: To determine the effects of supplemental testosterone to achieve          testosterone levels in the upper normal physiologic range on central adipose tissue          (abdominal VAT, SAT, and hepatic fat) and peripheral skeletal muscle fat (IMCL and          intermyocellular fat).        2. Secondary Objectives: To determine the effects of supplemental testosterone to achieve          testosterone levels in the upper normal physiologic range:             1. on hepatic glucose output (HGO) and peripheral glucose disposal (Rd)             2. on hepatic glucose synthesis from glycogen, glycerol and the Krebs cycle using               [1,6-13C2C] glucose, D2O, and [U-13C3] palmitate isotope dilution studies             3. on adiponectin and apoprotein B levels             4. on basal metabolic rate (REE, R/Q) as related to changes in skeletal muscle mass      Results of this study will provide greater understanding whether androgen therapy enhances     insulin sensitivity by decreasing HGO, decreasing adiponectin production, improving     peripheral Rd and if these desired effects are achieved, whether they are due to reductions     in VAT, SAT, liver fat, IMCL or effects of augmenting muscle mass per se. Results will     generate hypotheses to investigate cellular and molecular mechanisms of androgen effects in     persons at risk for the Metabolic Syndrome.   "
192418|NCT00365807|"     The current study examined the effectiveness of a behaviorally-based group intervention for     overweight children and their families. The target intervention was compared to an enhanced     standard of care treatment. The impact of both treatment programs on numerous outcomes was     explored.   "
192419|NCT00365820|"     This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation     in patients with non-cancer pain.   "
192420|NCT00365833|"     We believe that certain cells in the human body (Circulating Endothelial Cells and     Endothelial Progenitor Cells) are related to risk of cardiovascular disease. It may be     possible to measure levels of these cells in patients who have had a kidney transplant and     predict their risk of developing cardiovascular disease.   "
192421|NCT00365846|"     The purpose of the study is to see if campath-1H can be used in first time renal transplant     subjects to prevent rejection and reduce the overall amount of anti-rejection medications     that patients take on a daily basis.   "
192422|NCT00365859|"     This study will provide long-term safety data for patients who are taking aripiprazole for up     to 1 year. Most patients enrolled in this study will have participated in a short-term study     with aripiprazole (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]).   "
192423|NCT00365872|"     This is a Phase II study using a combination of external beam radiation with intratumoral     injection of dendritic cells (white blood cells) as neo-adjuvant treatment for patients with     high-risk soft tissue sarcoma. The purpose was to determine if an injection of the patient's     own immune related white blood cells into their tumor would strengthen the immune system to     fight against their cancer.   "
192424|NCT00365885|"     The purpose of this study is to determine the value of shared health information on care     quality and costs when this information is used to notify care providers about concerning     health events for patients cared for by a community-based network of providers.   "
192428|NCT00365937|"     Open-label single center study. Patients will be divided in four groups of 7. Group 1: 8     melanoma-specific peptides in saline; Group 2: same mix of peptides + Montanide ISA51; Group     3: same mix of peptides + IMP321 500 µg; Group 4: same mix of peptides + IMP321 500 µg +     Montanide ISA51. These vaccines will be administered every 3 weeks on 5 occasions by     intradermal and superficial subcutaneous injections.   "
192429|NCT00365950|"     To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the     treatment of DVT/PE   "
192430|NCT00365963|"     The purpose of this study is to find out if patients with lung cancer and their main informal     caregiver (person providing physical, emotional, or financial support) are helped by getting     information, support, and decision making tools through a computer system called CHESS(the     Comprehensive Health Enhancement Support System)   "
192431|NCT00365976|"     The purpose of this study is to examine whether insomnia due to chronic low back pain can     improve with use of eszopiclone.   "
192432|NCT00365989|"     This is a phase 3 study to determine the safety of the new features to the FDA approved     ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.   "
192433|NCT00366002|"     This study will evaluate safety, efficacy and patient's perception of outcome after treatment     with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in     patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or     tolterodine extended release (ER) therapy.   "
192434|NCT00366015|"     This study will combine coronary stenting with minimally invasive robotic coronary bypass     surgery, accomplished with the use of the da Vinci robot, to restore blood flow to occluded     coronary arteries. Two previously approved and commonly performed procedures used to treat     coronary artery disease(coronary stenting and robotic bypass surgery) are being combined into     a hybrid surgery in a specialty built operating room. Patients with low risk coronary lesions     will undergo cardiac hybrid revascularization using stenting and LIMA to LAD robotic bypass     concomitantly. Patients' postoperative bleeding rates, angiographs and complication free     rates will be recorded.   "
192435|NCT00366028|"     Evidence-based clinical practices (EBCPs) are often not widely adopted, despite extensive     efforts to influence individual practitioners to use them. The aim of the project is to work     with Veterans Integrated Service Networks (VISN) 1, 10, and 23 and their medical centers to     create and test organizations that facilitate the use of EBCPs. The research objectives are     to: Test the effectiveness of the proposed organizational model in comparison with a more     limited data-feedback strategy in improving system use of a selected EBCP; Identify and     analyze organizational factors that affect model implementation; Test the feasibility of     intervention activities to introduce and support the model.   "
192436|NCT00366041|"     After severe burn injury, the full-thickness burn areas are excised (in the first week) and     then temporarily covered with allograft (cryogenic preserved cadaver skin). This first     covering is then replaced with thin skin meshed autograft.      In this study, either the dermal substrates cellularised LG002 or uncellularised LG002 will     be grafted, after excision, in symmetrical areas, in replacement of the allografts. Fourteen     to twenty one days after this first covering, the dermal substrate will be covered with thin     skin meshed autograft.   "
192437|NCT00366067|"     The purpose of this study was to determine whether antiepileptic drug phenytoin is effective     in the treatment of chronic asthma in children.   "
192440|NCT00366106|"     The current study is being conducted to evaluate the possibility that a different schedule of     bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of     peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib     dosing for a longer period.   "
192441|NCT00366119|"     The purpose of this study is to assess which drug is more effective of Ramiprin®(ramipril)     and Tritace®(ramipril) in the Treatment of Essential Hypertension   "
192442|NCT00366132|"     The purpose of this clinical study is to compare the safety and effectiveness of shockwave     treatment combined with standard-of-care treatment, to standard-of-care treatment alone to     induce healing of a chronic plantar foot ulcer in subjects with diabetes mellitus. For the     purpose of this study, the definition of plantar foot ulcer is a wound or open sore that     involves the plantar(bottom) aspect of the foot, and the definition of chronic is a duration     of 6 weeks or greater with a lack of response to treatment.   "
192443|NCT00366145|"     The purpose of this study is to evaluate the efficacy and gather additional safety of     Prochymal in subjects who have failed to respond to steroid treatment of Grades B-D acute     GVHD.   "
192444|NCT00366158|"     The primary efficacy objective of this clinical investigation is to demonstrate that the     Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term     incidence of unnecessary ventricular pacing in patients with intact AV conduction.   "
192445|NCT00366171|"     A one year extension study using flexible doses, 20 or 30 mg daily, of open-label bifeprunox.   "
192460|NCT00366366|"     This study assessed the immunogenicity and safety of two vaccination regimens that employed     either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two     groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2     doses of the primary vaccination course. At 5 months of age, they received either the     DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib     vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV     vaccine at birth and at 1 month of age.   "
192461|NCT00366379|"     This study will assess the efficacy, safety and tolerability of increasing doses of GK     Activator (2) in patients with type 2 diabetes whose condition has not been optimally     controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their     previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for     12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a     target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is     <3 months, and the target sample size is 100-500 individuals.   "
192446|NCT00366184|"     This study will examine whether transcranial magnetic stimulation (TMS) of the brain used in     combination with carbidopa-levodopa is more effective in temporarily improving the speed of     hand movement in stoke patients than TMS alone. In TMS, a wire coil is held on the patient's     scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that     stimulates the brain. The effect of TMS on the muscles is detected with small metal disk     electrodes taped to the skin of the arms or legs. Carbidopa-levodopa is a medication usually     used to treat Parkinson's disease, but it may improve the effect of theta burst stimulation.      Two kinds of TMS are used in this study. In single-pulse TMS one or two pulses are delivered     at a time in order to measure brain activity at that moment. In repetitive TMS (rTMS), a     series of pulses are given in short bursts, temporarily altering brain activity. The type of     rTMS used in this study is called theta burst stimulation.      Healthy normal volunteers and people who had a stroke 6 months or more before entering the     study may be eligible to participate. All candidates must be between 18 and 90 years of age.     Stroke patients must have had significant hand weakness and made a moderate or good recovery     and must be able to move either the thumb or the wrist on the affected hand reasonably well.     Normal volunteers must be right-handed.      Participants complete the testing for this study in four main sessions scheduled at least a     week apart and five short follow-up sessions. At each main session, participants take either     a carbidopa-levodopa tablet or a placebo (a look-alike inactive substance). Stroke patients     have their arm and hand function assessed using two tests. One requires them to insert pegs     into holes; the other includes writing, lifting various objects, and performing activities     like turning pages, feeding or stacking checkers.      All subjects complete a questionnaire regarding their mood and alertness and then perform     tests of thumb or wrist movement. For this test, a small electrical stimulus is applied to     the side of the hand and the subject must respond to the stimulus as quickly as possible by     making a thumb or wrist movement. This is repeated several times over about 3 minutes. A     second test follows in which the subject moves the thumb or wrist in response to a beep from     a speaker. This test is repeated several times over about 8 minutes. Some measurements are     taken using single-pulse TMS during the beginning, middle and end of this test. In two of the     four sessions, theta burst stimulation is applied after the single-pulse TMS and in the other     two sessions, sham theta burst stimulation is applied.      Five follow-up sessions are scheduled one day after each main session and one week following     the final one. In these sessions, subjects perform an abbreviated form of the thumb movement     tests.   "
192447|NCT00366197|"     This trial examines weaning outcomes using the rapid shallow breathing index rate.   "
192448|NCT00366210|"     The purpose of this study is to compare modified CI therapy for strokes survivors with very     limited function to an alternative package of conventional physical rehabilitation techniques   "
192449|NCT00366223|"     The purpose of this study is to determine the changing patterns of infection caused by     Candida species in urban medical centers and its influence on patient outcomes. A     retrospective cohort study design will be employed with the main outcome measure being     hospital mortality. Secondary outcomes including microbiologic clearance of the infection,     duration of hospitalization, and the intensive care unit (ICU) length of stay will also be     assessed.   "
192450|NCT00366236|"     The purpose of this study is to determine the effect of nitazoxanide tablets in treating     diarrhea caused by Entamoeba histolytica in adults and adolescents.   "
192451|NCT00366249|"     The purpose of this study was to look at the safety and effectiveness of a once-daily dose of     tigecycline compared to ertapenem for the treatment of diabetic foot infections. The     co-primary efficacy endpoints were not met.   "
192452|NCT00366262|"     The purpose of this study is to provide an initial assessment of the gastrointestinal safety     of a 7-day regimen of PLA-695 compared to placebo or naproxen.   "
192453|NCT00366275|"     The purpose of this study is to determine the rate and duration of complete remission and     molecular response in patients with relapsed/refractory follicular lymphoma, using a combined     treatment with rituximab plus chemotherapy followed by in vivo purged peripheral blood stem     cells (PBSC) mobilization and autotransplant.   "
192454|NCT00366288|"     This study is to evaluate the safety and tolerability of single, ascending doses of PAZ-417     in healthy young and healthy elderly subjects. The effect of a high fat meal on the     metabolism of PAZ-417 will also be studied, along with blood levels of PAZ-417 . Changes in     cognitive function will be assessed.   "
192623|NCT00360386|"     -  To compare the Kinetics of inhibition of platelet aggregation (aggregometry) and          platelet activation (flow cytometry) with different loading doses of clopidogrel        -  To evaluate the effect on various parameters of inflammation and necrosis and the safety          of these loading doses   "
192455|NCT00366301|"     The purpose of this study, which is being conducted at 100 centers throughout the United     States, is to determine whether Lantus, a long-acting insulin injection, either alone or in     combination with metformin, is effective in reducing C-reactive protein (CRP) in adults with     type 2 diabetes. CRP is a marker of chronic low-level inflammation, a new risk factor for     diabetes, heart attack, stroke, and other cardiovascular events.   "
192456|NCT00366314|"     The purpose of this study is to quantify and analyze the line accesses for each of the 3     participating ICUs.      The hypothesis is that the CICU will have a significantly higher number of line accesses than     the other units. Analyzing the data will assist the researchers in identifying best practices     and ultimately, reduce the BSI rate in the CICU.   "
192457|NCT00366327|"     An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to     evaluate long-term safety.   "
192458|NCT00366340|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of a     13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate     (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months     (infant series) and at 11-12 months of age (toddler dose) in Germany.   "
192459|NCT00366353|"     An important part of how we decide when a patient is ready to have their breathing tube     removed is to have a person breathe without any machine breaths while the breathing tube is     still in place. We call this a spontaneous breathing trial.      Commonly, while patients have the breathing tube, they are given medications to keep them     sedated and comfortable so breathing does not bother them. These medicines are often stopped     before the spontaneous breathing trial so they can be more awake for the test.      There are signs the doctors look for during the spontaneous breathing trial that suggest the     patient might not be ready for the breathing trial to come out. Signs like fast breathing,     small breaths, a fast heart rate, or looking more anxious than usual may mean that the     patient is not ready to come off the ventilator. However, if someone has been given sedation     medicines the entire time they have had a breathing tube and are then woken up, they may     naturally get very anxious. They may show the same signs as someone who is failing their     breathing test, but in their case these signs are only because they are anxious.Doctors may     mistake these signs as failing the breathing test and may not pull the breathing tube out     even though the patient is really ready for it to come out.      We wish to try and find out if patients do better during their spontaneous breathing trials     if they are continued on some sedative medicines to treat anxiety or if they do better if the     medicines are stopped before the test.   "
192487|NCT00366717|"     Cytomegalovirus (CMV) infects most of the world population. This study is to understand if     chemotherapy will increase the chance of reactivating CMV. The results may help us in     determining when treatment is needed and perhaps Why is it needed.   "
192462|NCT00366392|"     The purpose of Project Magnify is to determine which of the two current strategies (large     print versus optical aids) for helping visually impaired students improve their reading     abilities works better. Our hypothesis is that optical aids work better than providing the     student with large print materials. Since large print materials are of one size only, and the     level of visual impairments among students varies greatly, it seems apparent that large print     materials will work well for some students, but not for all. An optical aid designed for each     individual student's level of impairment seems to hold more promise in helping each student     reach their maximum level of performance. Although Project Magnify is designed to increase     reading abilities, it is expected that students will also develop greater independence and     confidence in home and community activities that require the use of vision.   "
192463|NCT00366405|"     The purpose of this study is to evaluate the visual outcomes, amount of inflammation,     endothelial cell loss, and the efficiency of a torsional handpiece compared to a conventional     handpiece during surgery to remove your cataracts.   "
192464|NCT00366418|"     This study will test the safety and effectiveness of using lower-dose rituximab given more     frequently for treating chronic lymphocytic leukemia (CLL). Studies have shown that, used     once a week for 4 weeks, rituximab was effective in up to 25 percent of patients with CLL.     New evidence shows that using lower and more frequent doses of rituximab can be more     effective in destroying leukemia cells and produce a better treatment response.      Patients 21 years of age and older with CLL who have received treatment with fludarabine may     be eligible for this study.      Participants take rituximab for 12 weeks. One dose of the drug is infused through an arm vein     over about 30 minutes on either day 1 (the first dose) or day 3 (the second dose). All other     doses are given as an injection under the skin. After the first week, patients can choose to     do these injections at home. Rituximab will be given 3 times a week for a total of 12 weeks.     Other medications are given to reduce the side effects and allergic reactions to the drug. In     addition to treatment, patients undergo the following tests and procedures:      Before treatment        -  Medical history, physical examination, electrocardiogram (EKG) and blood tests.        -  Bone marrow and lymph node biopsies (surgical removal of a small tissue sample).        -  Computed tomography (CT) and positron emission tomography (PET) scans. CT uses special          x-rays to provide images of the neck, chest, abdomen and pelvis. PET uses a radioactive          sugar to identify areas of disease.      During treatment (study weeks 1-12)        -  Medical history and physical examinations at weeks 3, 6 and 12 to evaluate drug side          effects, plus weekly telephone checks and interim visits when needed.        -  Blood tests every other week to evaluate blood counts.      Evaluations after treatment (follow-up 3 months to 12 months)        -  Blood tests at follow-up visits at 3, 6, 9 and 12 months after treatment to evaluate          blood counts.        -  Bone marrow aspiration and biopsy at 3 months after treatment to examine the effects of          rituximab on bone marrow cells.        -  CT scans of the neck, chest, abdomen and pelvis at 3, 6, 9 and 12 months after treatment          to evaluate the response to treatment.   "
192465|NCT00366431|"     The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of     MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic     non-malignant pain.   "
192466|NCT00366444|"     A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain     following bunionectomy surgery.   "
192467|NCT00366457|"     The main purpose of this study is to learn whether or not the combination of gemcitabine,     bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic     cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop     cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved     by the FDA for the treatment of colorectal cancer but is still considered investigational for     treating pancreatic cancer.   "
192468|NCT00366470|"     There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB     when given in addition to normal TB therapy. This needs to be proven with a controlled     clinical trial. People receiving Vitamin D with anti TB therapy will be compared against     people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery     (as shown by a quicker sputum culture conversion).   "
192469|NCT00366483|"     To assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral     doses of lecozotan SR in healthy young and elderly subjects.   "
192470|NCT00366496|"     To determine quality of vision post cataract extraction and intraocular lens (IOL)     implantation of 2 different acrylic intraocular lenses: Acrysof® Single-Piece IOL and     Acrysof® WF, through evaluation of contrast sensitivity, glare testing, visual outcomes,     wavefront, corneal topography, and patient satisfaction.   "
192471|NCT00366509|"     This study will examine bacteria and toxins in the mouth, lung and digestive system that may     be the cause of various diseases or symptoms. H. pylori is a bacterium that produces various     toxins that may contribute to lung problems. This study will examine specimens collected from     the mouth, teeth, lung, digestive tract and blood to measure H. pylori and its toxins and     their effects on cells.      People 18 years of age and older with or without gastrointestinal disease may be eligible for     this study. These include people without a history of lung disease as well as patients with     any of the following: lymphangioleiomyomatosis, asthma, sarcoidosis, other chronic or genetic     lung disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis or eosinophilic     granuloma).      Participants may undergo the following tests:        -  Blood and urine tests, chest x-ray.        -  Measurement of arterial blood gases: A small needle is placed in an artery in the          forearm to collect arterial blood.        -  Lung function tests: Subjects breathe deeply and occasionally hold their breath. They          may also receive a medication that expands the airways.        -  Fiberoptic bronchoscopy with lavage and bronchial brushing: The subject's mouth and          throat are numbed with lidocaine; a sedative may be given for comfort. A thin flexible          tube called a bronchoscope is advanced through the nose or mouth into the lung airways          to examine the airways. Saline (salt water) is then injected through the bronchoscope          into the air passage and then removed by gentle suction. Next, a small brush is passed          through the bronchoscope and an area of the airway is brushed to collect some cells for          examination.        -  Mouth rinsing or teeth brushing to collect cells.        -  Endoscopy: A small needle and catheter (thin plastic tube) are placed into an arm vein          to administer fluids and medications through the vein. A sedative may be given. The          throat is numbed with lidocaine and a thin flexible tube called an endoscope is inserted          through the mouth and down the esophagus into the stomach and upper part of the small          intestine to examine those areas.   "
192472|NCT00366522|"     To evaluate the safety and tolerability of a single dose of LXR-623 in healthy subjects.   "
192488|NCT00366730|"     The purpose of this study is to determine the effect of nitazoxanide suspension in treating     diarrhea caused by Entamoeba histolytica in children.   "
192489|NCT00366743|"     The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare testing and     high order aberrations induced by different laser technologies and to evaluate differences in     aberrometer technology. We hypothesized that there will not be differences among conventional     or wavefront guided treatments.   "
192502|NCT00366912|"     Measurement of Work of breathing (WOB), as well as pressure time product (PTP) of     transdiaphragmatic pressures to evaluate the degree of muscle activity and muscle unloading     during non-invasive ventilation.      The study makes comparison of a new developed auto adjusting controlled mode and a regular     spontaneous mode.   "
192503|NCT00366925|"     The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments     over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks,     followed by 6 weeks with one Adacolumn® apheresis treatment) in patients with active     ulcerative colitis.   "
192504|NCT00366938|"     This study will investigate the efficacy and safety of lumiracoxib in patients with primary     knee osteoarthritis (OA).   "
192473|NCT00366535|"     This study will examine the safety and effectiveness of the experimental drug, neurotropin,     for preventing or easing pain associated with fibromyalgia. A disorder that primarily affects     women, fibromyalgia causes widespread aching and stiffness in muscles. Neurotropin has been     used in Japan for many years to treat various chronic painful conditions, including     fibromyalgia.      Women with fibromyalgia who have been treated unsuccessfully with standard therapy may be     eligible for this study. Patients must have a history of widespread pain for more than half     of the days in each of the three months before they enter the study. Candidates are screened     with a medical history, physical examination, blood and urine tests, questionnaires and an     electrocardiogram (EKG).      Participants take their usual medications for fibromyalgia in addition to either neurotropin     or a placebo (look-alike medicine with no active ingredient). At 6 weeks and 12 weeks into     the study, they return to the NIH Clinical Center for evaluation of their sensitivity to pain     and level of physical capability. After 12 weeks, study subjects cross-over their     medication; that is, patients who took neurotropin for the first 12 weeks of the study take     placebo for the next 12 weeks, and vice-versa. Again, after 6 and 12 weeks, patients return     for evaluation.      Participants have blood and urine tests six times during the study and complete     questionnaires each week about their pain, symptoms, and activities.   "
192474|NCT00366548|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of a     13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared     to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given     concomitantly with routine paediatric vaccinations.   "
192475|NCT00366561|"     The purpose of this retrospective study is to identify all neonates (newborns < 30 days of     age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have     suffered neurological complications following cardiac surgery. This retrospective study is     important to identify the incidence, care and follow-up of neurological complications at this     institution   "
192476|NCT00366574|"     The purpose of this study was to evaluate the performance of the INTRALASE®, a laser keratome     which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our     hypothesis is that there is no difference between the 2 devices.   "
192511|NCT00367029|"     Individuals who are not physically active are at risk for developing heart disease, stroke,     and diabetes. Using motivational print materials is one way to encourage individuals to     increase their physical activity. This study will evaluate the effect that an enhanced     version of an individualized, print-based motivational program has on increasing physical     activity among sedentary individuals.   "
192512|NCT00367042|"     Mohs Micrographic Surgery is a well established method for treatment of cutaneous     malignancies. Part of this technique requires marking skin surrounding the tumor. There are     two ways of marking the tissue, lightly scoring it with a scalpel or marking it with a     surgical marker.      This study is to determine if there is a noticeable difference in outcome between patients     who have their tissue lightly scored with a scalpel or marked with a surgical marking pen.   "
192624|NCT00360399|"     This study will compare different treatments for depression in order to identify which     factors predict effectiveness, and will include a companion study which investigates     combining treatments and long term effectiveness.   "
192773|NCT00369915|"     A previous study showed that the intravenous administration of scopolamine produces     antidepressant effects. This study is designed to determine if other routes of administration     of scopolamine produce antidepressant effects.   "
192477|NCT00366587|"     Cataract is prevalent throughout the world and IOLs are routinely implanted after the     extraction of the cataractous lens. It is the most frequently performed surgery in the United     States with an estimated 2-3 million procedures performed annually. With the aging population     on the rise, as well as the increasing popularity of refractive intraocular lenses, the     number of intraocular surgeries continues to rise. Over the years, the surgical technique has     evolved from intracapsular extraction to modern phacoemulsification. This development has     helped with the evolution of IOLs as well. The IOLs have advanced extensively: different     materials and designs are available, permitting implantation through smaller, sutureless     incisions. Traditional IOLs are of monofocal design providing vision at one distance,     typically far. Patients implanted with traditional monofocal IOLs usually require glasses for     near distance tasks such as reading. The new multifocal IOLs offer the possibility of seeing     well at more than one distance, without glasses or contacts.      The AcrySof ReSTOR (Alcon Laboratories) uses apodized diffractive technology — a design that     responds to how wide or small the eye's pupil might be — to provide near, intermediate, and     distance vision. Clinical studies used to support the March 2005 FDA approval showed that 80%     of people who received the lens did not use glasses for any activities after their cataract     surgery; 84% who received the lens in both eyes had distance vision of 20/25 or better, with     near vision of 20/32 or better.      ReZoom (Advanced Medical Optics) is a multifocal refractive zonal IOL that distributes light     over five optical zones to provide near, intermediate, and distance vision. The ReZoom is a     second-generation multifocal and was FDA-approved in March 2005. In a European study of 215     patients, 93% of ReZoom recipients reported never or only occasionally needing glasses. The     combined use of multifocal intraocular lenses is often a solution to best meet the patients'     refractive needs. There has been speculation that the implantation of ReSTOR in one eye and     ReZoom lens in the fellow eye can provide patients a larger range of useful vision in the     near range.      The purpose of this study is to evaluate visual outcome and patient satisfaction after     implantation of a diffractive multifocal IOL (ReSTOR) in one eye and a refractive multifocal     IOL (ReZoom) in the fellow eye after routine phacoemulsification and compare it to a control     group of patients implanted bilaterally with ReSTOR with both eyes targeted for 0 to ±0.25 D,     and to a group of patients implanted bilaterally with ReSTOR with the non-dominant eye     targeted for +1.00 D and the dominant eye targeted for 0 to +0.25 D.   "
192478|NCT00366600|"     Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the     same.   "
192479|NCT00366613|"     This study involves using both a device that seals the capsular bag (where the lens is     located) allowing safer irrigation of the capsular bag and sodium chloride to irrigate the     capsular bag during cataract surgery on children. The purpose of this study is to determine     if the use of the device, Perfect Capsule, along with sodium chloride reduces the development     of posterior capsule opacification (PCO), a possible complication of cataract surgery. PCO is     the clouding of the rear portion of the natural membrane or capsule that holds the artificial     lens. It requires additional procedures to correct the problem. Sodium chloride is not     usually used during cataract surgery. It will be used to irrigate the capsular bag and remove     any residual cells that contribute to the development of PCO. Perfect Capsule will prevent     the sodium chloride from touching other parts of the eye. The goal of this study is to     determine if irrigation with sodium chloride will lower the incidence of PCO after cataract     surgery.   "
192480|NCT00366626|"     The purpose of this study is to determine whether naltrexone (an opiate blocking agent     approved for the treatment of alcohol dependence) is more effective in the reduction of     alcohol craving and drinking compared to placebo in individuals with particular genetic     predisposition.   "
192481|NCT00366639|"     The purpose of the ADHERE study is to develop a multi-center, observational, open-label     registry of the management strategies of patients treated in the hospital for acute Heart     Failure in the United States.   "
192482|NCT00366652|"     The purpose of this study is to evaluate the effects of multiple doses of DVS SR and     duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.   "
192483|NCT00366665|"     To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System     phacoemulsification units during routine cataract extraction.   "
192484|NCT00366678|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of a     13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given     concomitantly with routine pediatric vaccines in France.   "
192485|NCT00366691|"     The purpose of this study is to compare the effectiveness of Acular LS® and Lotemax® in the     prevention of inflammation in the eye after cataract surgery. Acular LS is made by Allergan,     Inc. It is a nonsteroidal anti-inflammatory drug (NSAID) and is approved by the Food and Drug     Administration (FDA) for use following cataract surgery. Lotemax is made by Bausch & Lomb. It     is a steroid and is also approved by the FDA for use following cataract surgery.   "
192486|NCT00366704|"     The purpose of this study is to determine the effect of bifeprunox or risperidone on the body     weight of patients with schizophrenia.   "
192490|NCT00366756|"     This study involves the use of VisionQuest 20/20 which is a new software program to test     visual acuity in children. The purpose of this study is to compare the results of VisionQuest     20/20 to two other ways to measure visual acuity. The two other tests are a standard eye exam     by an ophthalmologist and electronic visual acuity (EVA) testing, a computerized version of a     standard eye test.      It is important to identify vision problems in children as early as possible. These problems     include amblyopia (lazy eye, or reduced vision due to lack of development in the visual     area of the brain), strabismus (eyes are not aligned correctly due to eye muscle problems),     and refractive errors (when you need glasses to see up close or far away). Early     identification of the vision problems allows them to be treated earlier which makes it more     likely that vision can be improved. VisionQuest 20/20 can be easily distributed to schools,     and it is easy for the child and the vision screener to use. The test can be performed by     volunteers instead of an ophthalmologist.   "
192491|NCT00366769|"     The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare and induced     high order aberrations induced by the new CustomVue software use for wavefront-guided LASIK.   "
192492|NCT00366782|"     Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children     under 5 years of age, causing serious respiratory tract disease. The purpose of this study is     to test the safety of and immune response to a new HPIV vaccine in healthy infants, children,     and adults.   "
192493|NCT00366795|"     Primary:      To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in     reducing the recurrence of ascites.      Secondary:      To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic     drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent     ascites.      The one-year double blind placebo controlled period is extended up to 2 years in a long term     safety study (PASCCAL-2).   "
192651|NCT00360776|"     This phase II trial is studying how well tipifarnib works in treating patients with anemia or     neutropenia and large granular lymphocyte leukemia. Tipifarnib may stop the growth of     leukemia by blocking blood flow to the cancer cells and by blocking some of the enzymes     needed for cancer cell growth.   "
192494|NCT00366808|"     A recent survey of trends among the members of the American Society of Cataract and     Refractive Surgery determined that laser in situ keratomileusis (LASIK) is the leading     surgical procedure for photorefractive corrections ranging from −0 to 3 diopters (D).1 The     same survey, however, showed a clear trend of participating refractive surgeons toward     surface ablation. Photorefractive keratectomy (PRK) was the first refractive surgery     procedure approved and performed using the excimer laser. Several techniques of epithelial     debridement have been tried with PRK-type surgery including mechanical debridement, laser     transepithelial ablation, a rotating brush, and alcohol debridement.      The Amadeus II microkeratome (Advanced Medical Optics Inc, Irvine, CA, USA) used for the     creation of a LASIK flap has an upgradeable platform that will allow the user to perform     mechanical separation of the corneal epithelium before photorefractive treatments. With the     use of this device, the corneal epithelium can be separated from the underlying stroma     without previous preparation of the corneal surface with alcohol. The separated epithelial     sheet can either be removed or replaced on the operated cornea after photoablation. This     surgical procedure, which has been called Epi-LASIK, represents an advanced alternative     surface ablation photorefractive procedure for the correction of ametropia. The purpose of     this study is to evaluate the clinical visual outcomes, healing rates, and patient     satisfaction when performing surface ablation procedures using mechanical vs. alcohol     separation of the epithelium.   "
192495|NCT00366821|"     Our hope is that the information from this retrospective study will provide information to     better serve our patients and their parents with risk stratification (levels of risk) and     clinical expectations of patients after cardiac surgery who have genetic abnormalities and     those who do not have genetic abnormalities.   "
192496|NCT00366834|"     This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus     dexamethasone and ondansetron is more effective in the prevention of vomiting than     dexamethasone and ondansetron alone following the administration of moderately emetogenic     chemotherapy.   "
192497|NCT00366847|"     This proposal is aimed at developing a novel method for modeling and analyzing clinical     factors impacting RV function, which can lead to a more reliable, consistent, and     comprehensive pre-operative treatment planning. In particular, the proposed work centers on     the creation of an accurate and clinically useful heart model with which to quantify,     visualize, and interpret several clinical findings that are central to the medical     decision-making process. The hypothesis is that by providing clinicians with 3D models that     capture numerous relevant patient findings in an integrated, quantitative manner they can     make more consistent, reliable, and accurate clinical assessments and may also be able to     predict factors complicit in RV dysfunction and impending failure.   "
192498|NCT00366860|"     A study was designed with two specific aims: (1) to assess the effect of soy bread, compared     with wheat bread, on markers of bone metabolism and cardiovascular health, and (2) to     evaluate whether soy bread consumption affects the metabolism of phytoestrogens. To answer     Aim 1, a double-blind randomized crossover trial was conducted. Individuals with an ability     to metabolize a specific isoflavone, daidzein, consumed 3 slices of bread (either soy or     wheat) daily over a 12-week period. After a 4-week wash-out period, subjects consumed 3     slices/day of the other type of bread. Markers of bone metabolism and cardiovascular health     were evaluated before and after each time period. To answer Aim 2, individuals who did not     metabolize daidzein at baseline entered a double-blind randomized trial of soy bread with or     without fructooligosaccharide (a type of dietary fiber) over an 8-week period. Subjects were     evaluated regarding their ability to metabolize daidzein to equol.   "
192499|NCT00366873|"     The purpose of this study is to measure calcium absorption in infants fed formula with and     without prebiotics.   "
192500|NCT00366886|"     The purpose of this current retrospective study is to perform follow-up analysis on the 22     children from the study # 621-2004 It is important to examine whether an elevated biomarker     of brain ischemia before and/or following cardiac surgery has any clinical or functional     implications as the child ages.   "
192501|NCT00366899|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of a     13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given     concomitantly with routine paediatric vaccinations in Italy.   "
192505|NCT00366951|"     Our purpose was to compare the efficacy and safety of Foley catheter with oxytocin and     extraamniotic saline infusion with oxytocin for induction of labor requiring cervical     ripening.   "
192507|NCT00366977|"     State-sponsored anti-tobacco campaigns are motivating large numbers of smokers to seek     advice, assistance, and support to make their cessation efforts more successful. Like many     states, Oregon has sponsored the implementation of a statewide telephone quitline to provide     information, referrals, and cessation support for callers. This study will answer key policy     questions about how to most effectively support smokers who call the Oregon Quitline for     assistance. The specific aims are to recruit 4,500 callers to participate in a 3 x 2     randomized trial comparing the cost and cost effectiveness of three levels of behavioral     intervention. We will also test two different policies on the availability of nicotine patch     therapy. Subjects will be interviewed by telephone at 6 and 12 months to assess smoking     status, quit attempts, and use of health plan anc community cessation services. Costs will be     assessed separately from the perspectives of the patients, health plans, the State (i.e.,     Oregon Quitline), and society. Cost per quit and cost per year quality-adjusted years of life     saved will be calculated from each of these perspectives.   "
192508|NCT00366990|"     Obese individuals are at risk for developing cardiovascular disease (CVD). Increasing     physical activity, losing weight, and reducing sodium intake may reverse arterial stiffness     and blood vessel damage that is linked to obesity. This study will evaluate the effectiveness     of a low sodium diet and a behavioral weight loss intervention in reducing arterial stiffness     in overweight young adults.   "
192509|NCT00367003|"     The purpose of the proposed study is to evaluate the safety, feasibility and efficacy of     chronic, high frequency stimulation of the subgenual cingulate white matter (Cg25WM) using     the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for     severe treatment-refractory Major Depression in twenty TRD patients, and to investigate     potential mechanisms of action of this intervention.   "
192510|NCT00367016|"     The purpose of this study is to look at measures that will help scientists understand the way     Omalizumab, an FDA-approved anti-allergy medication, works.   "
192513|NCT00367055|"     It has been shown in previous study that progressive glycemic deterioration was associated     with progressive loss of b-cell function, measured by the decrease in plasma insulin levels,     irrespective of the therapy used (diet, sulfonylureas or metformin).There is growing evidence     that thiazolidinediones could have a positive action on the b-cell function. But it has not     yet been demonstrated that they could protect from a deterioration in insulin secretion in     the long term. So, it appears interesting to study the long term evolution of the b-cell     function and the possible protection with rosiglitazone in patients with type 2 diabetes     showing evidence of loss of b-cell function with metformin alone.   "
192514|NCT00367068|"     The objective of this study is to determine the efficacy and safety of treatment with     intrathecal baclofen for severe spasticity in children with cerebral palsy.   "
192515|NCT00367081|"     Neurological manifestations of Cerebral toxoplasmosis or Toxoplasmic encephalitis (TE) in     most advance stage HIV infected patients composed of fever, headache, alteration of     consciousness with focal neurological signs/symptoms such as include hemiparesis, cranial     nerve palsies, and ataxia. Generalised convulsions, in ¾ of patients. Moreover meningeal     irritation sign or herniation sign may be presented as life threatening condition   "
192516|NCT00367094|"     This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult     Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure     is not adequately controlled with benazepril monotherapy during a 4 week run-in period will     be randomly allocated to double blind treatment over 8 weeks with either a combination of     benazepril/hydrochlorothiazide per day or continuation of benazepril per day.   "
192517|NCT00367107|"     Background: The number of adults with autism is expected to rise significantly in the near     future, due to two main reasons: First, a dramatic increase in the estimates of the     prevalence of autism starting in the mid 1980s; Second, the clinical diagnosis of autism was     first introduced during the 1950s, and those diagnosed with autism back then are only now     entering middle age. Few studies, however, have focused on the outcomes of adult autistic     individuals, and very little is known about the course of autism in adulthood and on the     familial burden resulting from caring for an autistic adult. We therefore propose to study     adult outcomes in autism, and to examine the influence of raising an autistic individual on     the parents.      Working hypothesis and aims: The primary objectives of the study are:        1. Determine clinical status and functioning of autistic adults.        2. Study the influence of raising and caring for an individual with autism on the          well-being of the parents.   "
192518|NCT00367120|"     This study will enroll patients with Bacterial Sinusitis who will be treated with either Zmax     (Azithromycin Extended Release) or Augmentin (Amoxicillin/Clavulanate). The purpose of the     study is to compare early resolution of symptoms between the two treatments. Patients will     report resolution of their sinusitis symptoms through a daily questionnaire. There will be     two follow-up telephone interviews on days 12 and 28 to evaluate quality of life,     satisfaction with therapy, and use of healthcare services.   "
192531|NCT00367289|"     All patients over 18 who undergo a revision of hip or knee arthroplasty will be included.     Patients undergo a CT of the hip joint. A radiologist will mark the presence of cysts and     bone loss and will assess implant stability.      After the surgery, the surgeon will fill a similar form.   "
192532|NCT00367302|"     The purpose of the study is to determine the feasibility of providing buprenorphine     maintenance to opioid-dependent offenders in a jail setting and of transitioning those     patients to buprenorphine maintenance in the community after their release.   "
192519|NCT00367133|"     The study involves the enrollment of patients over 18 years of age with diabetic macular     edema(DME). Patients with one study eye will be randomly assigned (stratified by visual     acuity and prior laser) with equal probability to one of the three treatment groups:        1. Laser photocoagulation        2. 1mg intravitreal triamcinolone acetonide injection        3. 4mg intravitreal triamcinolone acetonide injection      For patients with two study eyes (both eyes eligible at the time of randomization), the right     eye (stratified by visual acuity and prior laser) will be randomly assigned with equal     probabilities to one of the three treatment groups listed above. The left eye will be     assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned     to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with     equal probability (stratified by visual acuity and prior laser).      The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal     injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will     receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will     be better.      Patients enrolled into the study will be followed for three years and will have study visits     every 4 months after receiving their assigned study treatment. In addition, standard of care     post-treatment visits will be performed at 4 weeks after each intravitreal injection.   "
192520|NCT00367146|"     The use of CNIs (CSA or FK) as primary immunosuppressive drugs after pediatric liver     transplantation is one of the main causes of chronic kidney disease in these patients in the     long term.      The study objective is the evaluation of safety of a modification in immunosuppression from a     dual-immunosuppression (CSA or FK plus steroids) to a triple immunosuppression (MMF plus CSA     (reduced dosage) plus steroids.   "
192536|NCT00367354|"     The purpose of this project is to analyze the respiratory motion process as relevant in     cardiac MRI imaging and apply the results for development of improved imaging methods and     software correction. To accomplish this, we will develop an imaging protocol for monitoring     respiratory motion.      The imaging protocol will be limited to less than five minutes of acquisition time so it may     be performed as piggyback acquisition following clinically prescribed imaging studies on     pediatric and adult cardiac MRI patients, but will also be applied to normal healthy     volunteers.      Hypothesis Characterization of respiratory motion will help improve image quality by allowing     optimized scan acquisition and retrospective correction of acquired data.   "
192537|NCT00367367|"     Studies have shown that endometrial sampling in the month prior to embryo transfer may     increase pregnancy rates. We wish to test this hypothesis by performing a hysteroscopy and     curettage in the month proceeding embryo transfer during IVF, IVF/ICSI or Frozen/Thawed     cycles.   "
192802|NCT00370305|"     The purpose of this study is to determine whether the insulin sensitizing effects of     rosiglitazone were accompanied by changes in 11ß-HSD1 expression and activity in different     tissues.   "
192521|NCT00367159|"     Urinary tract infection (UTI) is a common problem in childhood associated with vesico-renal     reflux (VRR) in 25-40% of children. A persistent VRR and repeated pyelonephritis may     predispose to renal scarring and chronic renal failure with an end-stage renal failure in up     to 3% of children.Defining a standard behaviour facing VRR in children is not easy because of     the lack of reliable evidence. Numbers of studies compare prospectively or retrospectively,     medical, endoscopical and surgical treatment.Surgical techniques are effective but invasive     and not free of complication. Medical treatment is submissive to a good observance. The     introduction of endoscopic techniques permits to prevent UTI and new renal failure by VRR     elimination. Since the beginning of the endoscopic treatment, several bulking agents have     been proposed. The ideal agent should be easy to inject, stable in time and should be safe.     Of course it should be at least as efficient as actual bulking agent. The use of Teflon was     the first wave of success of endoscopic treatment. But sudden passion of Teflon has been     darkened by the notion of migration. Since, others substances have been proposed, autologous     or exogenous, resorbable or not. But none was ideal and no solutions were found facing     problem of biocompatibility or long-term stability.Using adipose tissue as a bulking agent is     ancient in plastic surgery and indications had known a leap forward in the last century with     Coleman who introduced a new technique called lipostructure. This technique has known a     growing interest in the restoration of all volume defects in plastic surgery because of the     stability of the graft. We propose to apply this technique to VRR management in children in     order to combine innocuousness and efficiency.   "
192522|NCT00367172|"     The goal of this randomized, controlled trial is to compare the effectiveness of a     community-based program of providing supervised antiretroviral therapy to HIV-positive drug     users, compared to having the patients take the medicines on their own.   "
192523|NCT00367185|"     In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used     since the 1960s and is regarded as the standard of care in elderly patients. We assess     whether the addition of thalidomide to this combination or adapted high-dose chemotherapy,     using a melphalan 100 mg/m2 -based regimen, would improve survival.   "
192524|NCT00367198|"     The mortality rate in chronic hemodialysis (CHD) patients remains excessively high and     approaches 21% per year. Among the many factors that adversely affects patient outcome is     uremic malnutrition, a unique form of deranged nutritional status. It is associated with     increased hospitalization and death risk in CHD patients. Several measures have been     identified to prevent uremic malnutrition in CHD patients, including efforts to optimize     dialysis regimen and dietary protein and energy intake. A large number of CHD patients suffer     from uremic malnutrition in spite of these aggressive measures. The inevitable protein     catabolic effects of the hemodialysis procedure are important factors leading to increased     prevalence of uremic malnutrition. Preliminary data suggest that oral nutritional     supplementation administered during the hemodialysis procedure counteracts these protein     catabolic effects and leads to net protein anabolism in the acute setting. In this proposal,     we hypothesize that Pro-Stat, a high nitrogen, enzyme-hydrolyzed, tryptophan-fortified,     collagen protein supplement will reverse the net protein catabolism observed during     hemodialysis procedure.   "
192525|NCT00367211|"     The purpose of this study is to evaluate the incidence of gastric ulcers following     administration of either PN 200 or Naproxen in subjects who are at risk for developing     NSAID-associated ulcers.   "
192526|NCT00367224|"     The purpose of this study is to determine if vitiligo patients develop tolerance to     ultraviolet light therapy, a type of treatment available for vitiligo.   "
192527|NCT00367237|"     This study is undertaken to compare the efficacy and onset of action of infliximab plus     methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active     psoriatic arthritis patients.   "
192528|NCT00367250|"     One important approach to change the natural history of advanced breast cancer is that of     designing new combination chemotherapies in which the best drugs already available are used     together with new anticancer agents devoid of clinical cross-resistance. The possibility of     exploiting the combined use of cetuximab and trastuzumab represents an option of potential     great impact on the probability of response and long-term therapeutic results for patients     with advanced breast cancer and HER2 overexpression.Therefore, patients with tumors that     demonstrate EGFR expression and clear-cut erbB-2 overexpression (3+) or limited erbB-2     overexpression (+ or 2+) will be included in the study. Patients will be treated with     trastuzumab and cetuximab to study the pharmacokinetics and potential drug/drug interaction     of both antibodies as well as the safety and tolerability of this novel combination     treatment.   "
192533|NCT00367315|"     This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of     patients with knee osteoarthritis (OA)   "
192535|NCT00367341|"     While there are many effective options for treating a major depressive episode, there are no     clinical markers that predict the likelihood of remission with an initial trial of either an     antidepressant medication or psychotherapy. More critically, there are also no reliable     predictors that might anticipate failure to such standard treatments either alone or in     combination. This project will characterize imaging-based brain subtypes that distinguish     groups of depressed patients who later remit or not to SSRI pharmacotherapy or cognitive     behavior therapy (CBT), respectively. To define these subtypes, a prospectively-treated     cohort of 100 patients will be randomized to receive either escitalopram (s-CIT) or CBT for     the first 12 weeks, with non-remitters to either first treatment crossed over to receive an     additional 12 weeks of treatment with combined treatment. Non-remitters to both treatments     will thus define a relatively treatment resistant third subgroup. Resting-state     18F-fluoro-deoxyglucose (FDG) positron emission tomography (PET) scans will be acquired prior     to initiating antidepressant therapy, with pre-treatment scan patterns associated with three     possible outcomes (CBT remission, s-CIT remission, and non-remission to both) assessed using     multivariate analytic methods. A second PET scan, acquired early in the treatment course,     will be used to assess the likelihood of response to the specific treatment first assigned.     The proposed studies are a first step towards defining brain-based biomarkers predictive of     differential treatment outcome in major depression; most critically, patterns distinguishing     patients at risk for treatment resistance. Identification of such biomarkers has additional     implications for future testing of novel therapies in patients with distinct brain     signatures, including development of evidence-based treatment algorithms for individual     patients.   "
192576|NCT00367887|"     This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and     pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B     (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV)     genotype      1-infected subjects who are either naive to treatment or who have previously failed treatment     (non-responders).   "
194356|NCT00389311|"     The purpose of this study is to determine if detectable changes in permeability of the lining     of the colon are caused by either application of HIV microbicide gels or medical procedures,     such as flexible sigmoidoscopy.   "
192538|NCT00367380|"     The study is a randomized open label clinical trial to verify the reproducibility of a     sporozoite challenge model for Plasmodium vivax in humans. The verification of the     reproducibility of such a model will make it possible to evaluate the efficacy of candidate     P. vivax vaccines in Phase 2a trials. The study is divided into two successive steps:      Step A Parasite Blood Donation: Volunteers will be recruited passively from a group of     patients who present with active P. vivax infection and accept to donate infected blood.     Samples of P. vivax infected blood will be collected and will be screened for infectious     diseases, according to standard blood bank procedures. Colonized Anopheles albimanus     mosquitoes will be fed with this blood using a Membrane Feeding Assay (MFA). Sixteen (16)     days after, selected positive mosquito batches will be used for step B.      Step B Challenge: After informed consent signature, a total of 18 healthy volunteers will be     randomly allocated to Groups 1, 2 and 3, of 6 volunteers each and will be challenged with the     bite of 3±1, P. vivax infected mosquitoes. Each group will be exposed to a different isolated     parasite. Volunteers will be closely monitored post infection, and will be treated as soon as     blood infection becomes patent as ascertained by microscopic examination of thick blood     smears (TBS). Comparison of data obtained in the three different groups will be used to     determine reproducibility of challenge model.      Primary objective: To demonstrate that naïve human volunteers can be safely and reproducibly     infected by the bite of An. albimanus mosquitoes carrying P. vivax sporozoites in their     salivary glands.      Secondary objective: To determine the influence of the type of parasite isolated on     reproducibility and safety of the challenge model with P. vivax in human volunteers      Hypothesis:It is possible to safely develop a reproducible P. vivax infection in human     volunteers using P. vivax experimentally infected An. albimanus mosquitoes.   "
192539|NCT00367393|"     Topical steroid use may lead to skin deterioration and spider veins. This study will examine     long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and     its effect on skin reconstitution of steroid-damaged skin and disease control.   "
192540|NCT00367406|"     Pertrochanteric and subtrochanteric femur fractures will be treated with a Gamma 3 nail or an     ACE Trochanteric nail.      Following topics will be assessed: fracture consolidation, mobility, pain, walking power,     agility.   "
192541|NCT00367419|"     We looked for the effectiveness of low-dose long-term prescription of erythromycin in     mustard-induced bronchiolitis obliterans   "
192542|NCT00367432|"     This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in     long-term administration in patients who completed N01020 [NCT00160165] or N01221     [NCT00280696].   "
192543|NCT00367445|"     To compare short-term efficacy and safety of Exubera vs Lantus in patients with type 2     diabetes mellitus   "
192544|NCT00367458|"     This study will examine the effects of atorvastatin, a statin (drug that lowers cholesterol)     on the human immunodeficiency virus (HIV). If not treated, HIV infection causes an incurable,     progressive deficiency in the immune system that leads to death, usually from disease that     takes advantage of weakened immunity. However, previous studies have suggested that if the     amount of cholesterol in infected cells is reduced, multiplication of HIV is also reduced. In     this study, researchers will examine the HIV viral loads, that is, amount of the virus in the     blood. They will evaluate the composition of the strain of the virus that patients carry (HIV     genotype), response of the immune system to the virus, and how genes may determine the way in     which the drug may or may not work against the strain of virus. Researchers plan to enroll 22     participants, anticipating a study to last 30 weeks for each participant.      Patients ages 18 or older with HIV infection, who are not pregnant or breastfeeding, who do     not have a known allergy to atorvastatin use, and who have not had a serious illness or     infection that required hospitalization within the 30 days before entering the study may be     eligible for this study. They will be assigned to random groups: one that to receive     atorvastatin and the other to receive a placebo, which has no effect on cholesterol or     ability of the HIV infection to multiply. Patients will remain in their groups and treatments     for 8 weeks. At the completion of 8 weeks, no matter the study group, all patients will be     required to discontinue all study-related medications for 4 weeks. After that period, the     study assignments will be switched, so that those previously taking the placebo will take     atorvastatin, and vice versa. The study will proceed for another 8 weeks, followed by a     period of stopping study-related medications and patients being observed for 4 weeks.     Throughout the study, patients will have regularly scheduled visits at the clinic. At those     visits there will be collection of blood samples, assessments of symptoms, physical     examinations, and questionnaires to complete. Blood tests may require fasting beforehand, and     blood samples will be used in standard tests, including those regarding the liver, kidneys,     muscles, blood cells, and pregnancy status. Specialized blood tests will determine viral     load, effects of the drug on the immune cells, and genetic influence on the drug's     effectiveness. The time spent for procedures during clinic visits...   "
192545|NCT00367471|"     The purpose of this study is to determine the optimal dose of lapatinib when administered     with carboplatin, paclitaxel, and trastuzumab in subjects with ErbB2-positive breast cancer     and with carboplatin and paclitaxel in subjects with ErbB2-negative breast cancer.   "
192546|NCT00367484|"     The objectives of the study are:      - comparison of the incidence and time course of the development of neutralizing antibodies     (NAbs) to Rebif after 48 weeks of therapy, to historical data from Serono clinical trial     databases to assess the safety and tolerability of Rebif®   "
192559|NCT00367666|"     This project is aimed at investigating the relative diagnostic and synergy of four state of     the art breast imaging techniques (magnetic resonance imaging (MRI), full-field digital     mammography (DMAM), ultrasound, and positron emission tomography (PET)) with respect to     determining the extent of breast cancer.   "
192547|NCT00367497|"     Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes     refractory to chemotherapy. Various second or third line chemotherapies, which are called     salvage chemotherapy, were developed without promising results. Improvement in efficacy by     adding relatively new agent, rituximab, to chemotherapy is now widely accepted in     non-Hodgkin's lymphoma. This study will test the safety and efficacy of adding rituximab to     existing salvage chemotherapy, ESHAP (R-ESHAP). Our aim is also to proceed to high-dose     chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP     therapy.   "
192548|NCT00367523|"     This study will explore how people with sickle cell disease (SCD) develop a complication     called pulmonary hypertension (PHTN), a serious disease in which blood pressure in the lungs     is higher than normal. PHTN is also caused by HIV, hepatitis C and schistosomiasis. Patients     who have both SCD and one of these other infections may develop more severe PHTN. The number     of Nigerians with SCD who also have PHTN is not known, nor is the cause of PHTN in this     population. This study will examine genetic material in people with and without SCD to     determine whether certain genes will allow doctors to predict which patients with SCD are     likely to develop PHTN.      Nigerian males and females 10 years of age and older with or without SCD may be eligible for     this study. Patients must have SS, SC, or SB thalassemia or other genotype; control subjects     must have hemoglobin A or AS genotype.      Participants undergo a complete medical history and physical examination, blood tests,     electrocardiogram (EKG), ultrasound tests of the heart and abdomen, and a 6-minute walk     (distance test) to determine exercise capacity. Blood tests include screening for HIV,     hepatitis B and C, schistosomiasis, hookworm and malaria. Patients who test positive for HIV,     hepatitis B or C, schistosomiasis, hookworm or malaria are referred for treatment at Ahmadu     Bello University Teaching Hospital in Zaria, Nigeria, and those who test negative for     hepatitis B are referred for vaccination. Genetic tests focus on genes involved in SCD, PHTN,     inflammation, blood vessel function and red blood cell function.   "
192549|NCT00367536|"     This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also     called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA).      About 24 subjects will take part in this study. Each subject's participation in this study     will last for about 10 weeks. During this study, each subject will receive 3 different types     of BZA/CE tablets plus an oral solution containing only BZA. The purpose of this study is to     learn how the tablet dosage forms dissolve and are absorbed by the body compared to the BZA     oral solution. In addition, information will also be learned about the safety and     tolerability of these dosage forms given to healthy postmenopausal women.   "
192550|NCT00367549|"     This is a randomized, double-blind trial looking at how nutrition intake is associated with     labor progress and complications.   "
192551|NCT00367562|"     TO ASSESS THE EFFICACY OF THE RENIN ANGIOTENSIN SYSTEM PLUS STEROIDS TO DECREASE THE AMOUNT     OF PROTEINURIA IN IGA NEPHROPATHY   "
192552|NCT00367575|"     The main aim of this randomized controlled trial is to evaluate the efficacy of an     Internet-delivered self-help intervention for problem drinkers in the general population.      Adult problem drinkers with home access to the Internet will be recruited from the CAMH     Monitor. Subjects will be randomly assigned to receive a website address where they can     obtain personalized feedback about their drinking, or to a no intervention control group.      Three-month and six-month follow-up surveys will be conducted by mail to assess drinking over     the following three month periods. Collaterals will be requested and interviewed after the     six-month follow-up. Subjects will be paid $40.00 and collaterals will be paid $20.00 for     their participation. Drinking at three- and six-months will be compared between the groups.     Subjects in the control group will be provided with the website address following the     six-month follow-up.   "
192553|NCT00367588|"     The purpose of this prospective, randomized study was to determine the efficacy of low     bacterial diet, in comparison to normal hospital diet, with gut colonization by aerobic Gram     negative rods and yeasts as primary endpoint. In addition, the occurrence of infections and     the total costs of hospital care were documented, in order to identify potential cost savings     by the use of either diet.   "
192554|NCT00367601|"     The strategy for combining therapeutic agents in cancer treatments has been successful in     multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways     involved in tumor growth. Nonclinical studies have demonstrated that the combination of     bevacizumab and erlotinib results in greater efficacy than either agent alone. Furthermore,     because there is little to no overlap in toxicity profile between the two agents, the     combination is expected to be well tolerated and may provide even greater benefit for     patients who are unable to receive cytotoxic therapy.   "
192555|NCT00367614|"     The purpose of this study is characterize the PK profile of single and multiple doses of     pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).   "
192556|NCT00367627|"     The most common soil transmitted helminthic infections(STHI) includes infection with Ascaris     lumbricoides, Trichuris trichiura, and Hookworm. Growth retardation, malnutrition, anemia,     impaired cognitive function and immunosuppression are main manifestations in children. Even     within the developing world, wide differences exist in prevalence rates. The poorest     countries have higher levels of STHI than those with a lower incidence of poverty. According     to an estimate made by the WHO, the prevalence of A. lumbricoides, T. trichiura and Hookworm     in South Asia was 27%, 20% and 16% respectively. Given that the prevalence of STHI in urban     slums in Bangladesh is much higher than the other parts of the world and Asia and that there     are major health and socio-economic consequences of such infections, it is important that we     come up with effective means of reducing the prevalence of such infections. 60-80% of     preschool children in urban slums of Bangladesh are infected with these STHI due to poor     hygiene . At present deworming at six months interval is recommended but the effectiveness of     this regimen of dewormig is questionable.      2. Hypothesis: Ante-helminthic treatment at every three month is more effective than     ante-helminthic treatment at every six months to reduce soil transmitted helminthic     infection, to reduce diarrheal and respiratory illness to improve nutritional status in     preschool children.      3.Objective: The main objectives of the proposed study is to compare the relative efficacy of     two different ante-helminthic treatment regimens to reduce the prevalence of STHI, diarrheal     diseases, respiratory illness and to improve nutritional status in children 4. Design: The     population of the study will be preschool children aged 2-5 year and will be selected     randomly from an urban of Dhaka. They will be divided into two groups randomly. One group     will get ante-helminthic at every three months interval and the other groups will get at six     months interval for one year. Stool samples will be collected at the baseline and after three     months completing one-year treatment of the above mentioned regimen. Blood haemoglobulin and     nutritional status will also be measured at baseline and after three months of completion of     treatment as mentioned above. The treatment will be 400 mg of Albendazole in a single dose.      5. Potential Impact: The findings of the research can be implemented by the government and     non-government organization.   "
192557|NCT00367640|"     To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms     and rescue medication usage   "
192558|NCT00367653|"     To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium     falciparum malaria.   "
192561|NCT00367692|"     To evaluate the safety of an orally administered single dose of PSI-697 in subjects with     scleritis, as a model of inflammatory disease. To evaluate by in vivo confocal microscopy     (IVCM) the effect of a single dose of PSI-697 on leukocyte rolling in the scleral blood     vessels of subjects with scleritis.   "
192562|NCT00367705|"     Crohn's disease (CD) in childhood is a chronic relapsing and remitting condition that has a     significant impact on growth and development. The disease is characterized by an increased     and unregulated immune response. The main therapy over the last 30 years has been     corticosteroids leading to remission in 50-80% of patients within 2-4 weeks. However, the use     of steroids in children is limited by side-effects including acne, moon-face, hirsutism,     hypertension, metabolic disturbances and above all reduced growth. Hence, pediatricians are     very interested to find alternative therapies. Therapeutic manipulation of gut flora with     probiotics promises to be a useful strategy for several disorders including inflammation of     the gut. The efficacy of the highly concentrated probiotic VSL#3 has been documented in     maintenance and prophylaxis treatment of pouchitis in double blind, placebo controlled     studies in adults. The aim of this study is to compare probiotic therapy with VSL#3 versus     placebo in maintenance therapy of children with mild to moderate CD, treated with either     5-ASA, corticosteroids (local or budesonide), imuran/6 mercaptopurine (MP), as long as no     change in medication dosage has been made in the previous 12 weeks (for imuran/6MP) or 4     weeks (for corticosteroids).   "
192563|NCT00367718|"     This study seeks to test the Efficacy in terms of rates of disease response in metastatic     nasopharyngeal carcinoma of the standard dose of velcade 1.3 mg/m2 given at the day 1,4,8,and     11 every 21 days schedule. The study uses a Simons 2 stage design and will enroll between     15-25 patients. Secondary endpoints studied include Pharmacokinetics, toxicities, EBV viral     load and molecular characterization of EBV in plasma.   "
192564|NCT00367731|"     After Initiation of HAART in peoples who living with HIV/AIDS in Thailand by the year 2000,     rapidly expanded HAART access of national project has been promoted in 2004. Free ARVs (For     CD4<200cell/cu.mm. or in symptomatic HIV with CD4<250 cell/cu.mm. )and CD4 monitoring has     been available. The first-line regimen is d4T+3TC+NVP in mainly the first time (Naive)     patients. CD4 response ), rate of opportunistic infection, and neurological outcomes were     measured. Rate of ARV change, adverse events,treatment failure, TB co-infection rate, percent     changing to EFV-based regimen or PI-based regimen were recorded.      Any Adverse Events including, Sever rash, Severe Hepatitis, Lipid abnormalities, Severe     Anemia and Other, common AEs will be analysed.   "
192565|NCT00367744|"     The purpose of this study is to examine the effect of rosiglitazone on limb fat and     mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that     does not contain stavudine (d4T) or zidovudine (AZT).   "
192566|NCT00367757|"     Patient Population: Patients with AF that is symptomatic and refractory to at least one     antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6     months, two episodes >6 hours within 1 year) or persistent (sustained episode <6 months     terminated by cardioversion or drug).      Purpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based     technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation   "
192567|NCT00367770|"     This 6-month open label study will evaluate the long term safety of bosentan (via oxygen     saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5     study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.   "
192568|NCT00367783|"     The purpose of this study is to determine whether CP-741,952 is effective in the treatment of     obesity and to determine 12 week safety and toleration.   "
192569|NCT00367796|"     This study will try to find the gene changes responsible for the birth defects in     craniosynostosis, Philadelphia type. Craniosynostosis syndromes are a group of conditions     that result from closure of one or more of the fibrous joints between the bones of the skull     before brain growth is complete. Because of the premature closure, the brain is not able to     grow in its natural shape; instead, it compensates with growth in areas of the skull where     the joints have not yet closed. The defects in raniosynostosis, Philadelphia type, include     skull malformations and webbing of the fingers and toes. Gene changes known to be involved in     other craniosynostosis syndromes have not been found in the Philadelphia type syndrome.     Therefore, finding the genetic basis of this disorder will provide important new information     regarding craniofacial and limb development.      This study includes members of a single large family affected with craniosynostosis,     Philadelphia type.      Participants have 1 to 2 teaspoons of blood drawn for genetic studies. A second blood sample     may be requested for further research. Some blood may be used to establish a cell line for     later studies. This involves growing the white blood cells from the blood sample. The cells     can be kept in the laboratory to make more DNA or can be frozen for later use in     craniosynostosis studies. Patients may also have their medical records reviewed.   "
192570|NCT00367809|"     The Wellness Interventions after Transplant (WIAT) Trial has reached its enrollment target.     This trial is no longer recruiting new patients. Those currently enrolled will be followed     for a year to evaluate trial outcomes.      The purpose of this trial is to determine if training in Mindfulness-Based Stress Reduction     can reduce symptom distress and improve quality of life in solid organ transplant recipients.     Primary study outcomes are depression, anxiety and insomnia symptoms, measured by     well-validated self-report scales. The impact of this program on objectively measured sleep     outcomes, use of health care resources and costs will also be evaluated.   "
192571|NCT00367822|"     The objective of this trial is to compare an individually optimized dose of the lisuride TTS     patch against placebo and against an individually optimized dose of oral ropinirole (active-     and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy,     safety, and quality of life.   "
192572|NCT00367835|"     To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and     oppositional symptoms.   "
192573|NCT00367848|"     The purpose of the study is to examine the efficacy and accuracy of Ultrasound in evaluating     occult fractures. We want to examine it on children that suffer from suspected fractures of     the foot and ankle and the results of the x-ray are either negative or inconclusive.   "
193198|NCT00374660|"     The purpose of this study is to determine the maximum tolerated dose (MTD) and to investigate     the efficacy, safety and pharmacokinetics of irofulven combined with oxaliplatin in patients     with advanced solid tumors.   "
192574|NCT00367861|"     Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized     and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all     malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells,     leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in     vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with     advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal     duration of treatment with Glivec® remains unknown. The objective of this study is to     determine the feasibility of Glivec® treatment interruption with reintroduction at     progression in GIST patients.   "
192575|NCT00367874|"     Managed detoxification is a first and necessary step prior to treatment and rehabilitation.     Detoxification can be a major obstacle for some patients, and the availability of managed and     safe withdrawal is a prerequisite for long-term treatment.      In our clinical practice we have felt the need for a standardised and safe detoxification     treatment regimen for our opioid addicts, as dependence on multiple drugs is so common.      Objectives        1. To assess whether a novel standardised treatment regimen - Buprenorphine (BPN) combined          with Valproate (VPA) - will result in fewer withdrawal symptoms during detoxification of          opiate–polydrug users than the existing treatment regimen, i.e. Clonidine (CLN) combined          with Carbamazepine (CBZ).        2. To determine whether there are differences in treatment retention between the BPN/VPA          and the CLN/CBZ groups.        3. To assess differences in clinical side-effects and biochemical interactions between the          two treatment regimens.   "
192652|NCT00360789|"     The purpose of this study is to test the hypothesis that adding functional strength training     to UK conventional therapy improves muscle function and walking than either UK conventional     therapy alone or increased intensity of UK conventional therapy.   "
192577|NCT00367900|"     This study will examine the roles of diet, lifestyle, genes, and their possible interactions     in the cause of Parkinson's disease, using information from the NIH-AARP Diet and Health     Study. The NIH-AARP study was established in 1995 to examine the roles of diet and lifestyle     in cancer. It included 567,169 AARP members 50 or older from California, Florida, North     Carolina, Pennsylvania, New Jersey, Louisiana, and the Atlanta and Detroit metropolitan     areas. In 1995, participants completed a comprehensive questionnaire on diet and a survey on     demographics, medications, as well as a follow-up survey in 1996 with more detailed questions     on lifestyle and medications, as well as cooking methods and early life dietary habits. A     third followup survey is currently underway.      The current NIH-AARP substudy on Parkinson's disease will include approximately 9,000     participants from the NIH-AARP study - 3,000 of whom reported being diagnosed with     Parkinson's disease on the most recent survey, and 6,000 control subjects. These study     participants provide two saliva samples for genetic analysis and may be asked to complete a     telephone interview. In addition, those with Parkinson's disease are asked permission to     review medical information regarding their diagnosis.   "
192578|NCT00367913|"     To date key drugs in the treatment of MAIS, M.malmoense and M.xenopi (Opportunist     Mycobacteria have been rifampicin and ethambutol. Clarithromycin and Ciprofloxacin are active     in vitro against these species of mycobacteria. The primary aim of this study was to compare     these to agents as supplements to rifampicin and ethambutol. A secondary aim was to assess     the vale of immunotherapy with M.vaccae.   "
192579|NCT00367926|"     To determine the effect of polysaccharides from American ginseng root on postprandial     glycemia in healthy individuals.   "
192580|NCT00367939|"     The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in     hypertensive patients not responding to treatment with ACE inhibitor plus calcium channel     blocker   "
192581|NCT00367952|"     The study will examine how safe and effective apricitabine is when given long term (as     ongoing treatment) to HIV patients who have already completed the AVX-201 trial   "
192582|NCT00367965|"     To demonstrate subjective sleep efficacy of eszopiclone 3 mg in subjects with insomnia     related to rheumatoid arthritis (RA).   "
192583|NCT00367978|"     This study evaluated the efficacy and safety of amlodipine/benazepril compared with that of     enalapril in the treatment of hypertension in African-American patients with type 2 diabetes.   "
192584|NCT00367991|"     The purpose of this study is to see if a naturally-occurring hormone called erythropoietin     changes the action of platelets in the blood. Patients with heart attacks are treated with     medicines to reduce the clotting action of platelets. This study is trying to determine     whether erythropoietin alters the clotting action of platelets in patients receiving     anti-platelet medicines. It is important to understand the effects of erythropoietin on     platelets since preliminary studies in animals suggest that erythropoietin may protect the     heart from damage during a heart attack.   "
192592|NCT00368095|"     Metabolic Syndrome (hypertension, diabetes mellitus, obesity, cerebrovascular-cardiovascular     disease) In Community Survey was performed in central Bangkok.      Prospective Cohort and intensive educated intervention (health promotion program in specific     high risk groups) were performed. The aim of the study is to identify high risk patients who     can develop serious complications from metabolic syndrome. An analysis of health outcomes in     multiple dimensions will be performed.   "
192593|NCT00368108|"     This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of     E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.   "
192594|NCT00359983|"     This study is evaluating antibody persistence at 1, 3 & 5 years post-fourth dose (i.e., at 2,     4 & 6 years of age, respectively) in subjects vaccinated in a previous study.      This protocol posting deals with objectives & outcome measures of the extension phase at     years 1, 3 and 5. The objectives & outcome measures of the first four doses are presented in     a separate protocol posting (NCT00129129).      This protocol posting has been amended in order to comply with the FDA Amendment Act of     September 26, 2007.   "
192595|NCT00359996|"     The purpose of this study is to determine whether a quality improvement intervention     including rapid quality improvement, a chronic care model, and best practices improves     diabetes care in community health centers and whether more intensive interventions enhance     care further.   "
192596|NCT00360009|"     The purpose of this trial is to study the mood and cognitive effects of deep brain     stimulation in Parkinson's disease.   "
192585|NCT00368004|"     This study will identify the genes responsible for uveal coloboma, an abnormal development of     the eye caused by incomplete closure of a normally-occurring gap in the eye (the optic     fissure) after the fifth week of life in a human embryo. There have been studies of families     in which more than one person has been affected by this disorder. Coloboma occurs in about 1     of 10,000 live births and may cause significant vision loss. Researchers seek a better     understanding of the genes responsible for this disorder.      Adults and children who have more than one member of the family with uveal coloboma may be     eligible for this study. Patients will undergo a detailed medical history and eye examination     appropriate for their age. The pupils will be dilated, through the use of eye drops. Dilation     will continue for 4 to 6 hours, and wearing of sunglasses can reduce temporary glare that     many patients may experience in brightly lit areas. In addition, pictures will be taken of     the front or back of the eye, a procedure that also involves dilation of the pupils. Patients     who have coloboma will undergo a complete physical examination. Blood samples will be     collected, with a total of about 2 tablespoons from patients ages 10 and older and about 1     teaspoon for each 5 pounds of body weight for younger patients. Also, patients with coloboma     may be asked to undergo X-rays , ultrasound, or other tests that are medically indicated.      To have enough DNA to study, the researchers may create a cell line to grow more DNA.     Laboratory samples will be coded so that there is no identifying information about     participants in this study. No other testing or research will be done on blood samples     collected unless patients give permission. The researchers will not provide information about     patients' health to other people without your express permission.   "
192604|NCT00360126|"     The precursor study (SCA101469) was an open-label, prospective multicentre study in adult     subjects diagnosed with bipolar disorder consisting of 36 weeks treatment with lamotrigine.     The current study is to provide 12 months post study access to open-label lamotrigine for     participants of the SCA101469 study.   "
192586|NCT00368017|"     The substantially increased cardiovascular morbidity and mortality rates in chronic kidney     disease (CKD) patients cannot be sufficiently explained by traditional coronary risk factors.     It is apparent that inflammation of the vessel wall plays an essential role in the     pathophysiology of atherosclerosis, and the strong association between elevated inflammatory     biomarkers and cardiovascular death further supports this mechanism. Approximately 50% of the     mortality in this population of patients is attributable to cardiovascular disease. Insulin     resistance is also a common problem in uremic patients. It has been shown that insulin     resistance may contribute to atherosclerotic cardiovascular disease. An intriguing     observation in CKD patients with advanced uremia is that the metabolic profile of these     patients is characterized by persistent low-grade inflammation, a state of insulin     resistance, and significantly increased prevalence of atherosclerosis. It is possible that     these metabolic derangements can be the inciting factors for development and progression of     uremic atherosclerosis. Peroxisome proliferator-activated receptor gamma (PPAR-gamma) is a     ligand-activated nuclear transcription factor found in cells of the immune system and the     vasculature, where it exerts an overall protective effect on the development of     atherosclerosis, in part through modulation of inflammation. The agonists for PPAR-gamma     improve not only the insulin resistance, but also have profound beneficial effects on     inflammation, oxidative stress, endothelium, and lipid metabolism. In this proposal, the     investigators hypothesize that short-term administration of a PPAR-gamma agonist     (pioglitazone) will improve the inflammatory state, insulin resistance, and endothelial     dysfunction in chronic kidney disease patients with advanced uremia.   "
192587|NCT00368030|"     The purpose of this study is to evaluate subjective sleep efficacy in subjects with insomnia     related to major depressive disorder.   "
192588|NCT00368043|"     The deleterious effects of institutionalized care on the health and growth and development of     children have been described. Early studies have shown that the effects of institutionalized     care on a child's growth and development may not be fully reversible. The exact mechanism     through which these early stresses affect bio-behavioral outcomes has yet to be determined. A     likely mechanism in which environmental influences could regulate both biological and     psychosocial development may be through the hypothalamic pituitary adrenal axis (HPA). Recent     advances in the area of brain research have enriched our understanding of the importance of     early life experiences on physical, cognitive, developmental, mental and behavioral health     outcomes. Children adopted from orphanages in countries as diverse as the former Soviet Union     and Guatemala provide an opportunity to learn more about the effect of deprivation on     neuro-endocrine function, physical growth, and developmental outcomes, including cognitive,     and behavioral measures.      This protocol proposes to study the changes of the HPA axis of the post-institutionalized     adoptive child, ages 10 months to 4 years, which may help elucidate the etiology of the     complex findings in this population. We will recruit 60 adopted children who experienced     institutionalized care and were recently adopted by a US family and 60 controls. Our primary     hypothesis is that a number of adopted children will have biochemical evidence of     stress-induced activation of the HPA axis and sympathetic adrenal medullary system. HPA     dysfunction will be evident by abnormal diurnal salivary cortisol levels, increased cortisol     and/or catecholamine excretion in 24 hours urine measurements, and dysregulation of autonomic     nervous system activity We also hypothesize that many of these responses will not normalize     with time and that there will be a correlation between these responses and growth and     behavioral disorders. In addition, we will examine nutritional intake and sleep patterns to     determine their effect on growth and developmental outcome.   "
192589|NCT00368056|"     To assess next day driving ability and psychomotor/memory function following a single night     time dose of eszopiclone in insomnia patients.   "
192590|NCT00368069|"     This is a safety and efficacy study of Keppra® extended release formulation - XR in patients     with epilepsy.   "
193751|NCT00381056|"     A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals     to evaluate the effect of teamwork training on the occurrence of adverse outcomes and     processes of care in labor and delivery.   "
192597|NCT00360022|"     The purpose of this study is to determine if the program that has been made to ease the     transition of care for adolescent patients with IBD from pediatric gastroenterology to adult     gastroenterology is effective to reduce the risk of disease flare during this period. Patient     satisfaction with this program will also be assessed.   "
192598|NCT00360035|"     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow     unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process     of cell death that is often inhibited in cancer cells.   "
192599|NCT00360048|"     The aim of this study is to determine if oxytocin administration is able to blunt LPS induced     increase of cytokines (TNF-α) and if there is a change in the endocrine response after     lipopolysaccharide administration in humans.   "
192600|NCT00360061|"     The effectiveness of cognitive behavioural therapy (CBT) for adolescents with type 1 diabetes     will be tested. This structured, time-limited, problem-orientated therapy will be used to     impact on psychosocial factors influencing diabetic control, with the patient and therapist     working together on specific goals to develop adaptive strategies.   "
192601|NCT00360074|"     The purpose of this study is to determine whether a body weight adjusted dose of thyroxin is     superior to treatment guided by laboratory results of thyroxin hormones in patients with     central hypothyroidism. Moreover beneficial effects of triiodthyronine supplementation are     investigated.   "
192602|NCT00360087|"     This study will assess the safety and efficacy of bosentan therapy (in a study known as     ASSET) for patients who have high blood pressure in the lungs associated with sickle cell     disease. That form of hypertension places people at risk for complications, including     shortness of breath, pain, pneumonia, and death. Previous studies have shown that bosentan     can be helpful in reducing pulmonary hypertension.      Patients ages 16 and older who have completed the 16-week treatment in the ASSET 1 or ASSET 2     study and who are not pregnant or breastfeeding may be eligible for this study. The research     will be conducted in about 25 hospitals in the United States and Europe. Up to 30     participants will be enrolled. The screening visit will involve a physical examination, blood     sample of about 3 teaspoons for laboratory tests, and a pregnancy test. Patients' doctors     will give them bosentan tablets (62.5 mg each), to take one in the morning and one in the     evening. After 1 month, patients will be told whether the dose should be increased to 125 mg     tablets to take twice a day. Two weeks after the increase in dose, a blood test will be done     to analyze the drug's effects on the liver. After the start of treatment, patients will     return for visits every 6 months, when there will be a 6-minute walking test to measure     exercise capacity and evaluate shortness of breath. There will be follow-up for patients up     to the end of the study and for 28 days after the last dose of bosentan is taken, to collect     information about side effects.      Some patients on bosentan have had changes in liver function and red blood cell count. Side     effects commonly reported are headache, flushed appearance, inflammation of the throat and     nasal passages, and gastrointestinal symptoms. If patients have sudden worsening in breathing     in the first few weeks after taking bosentan, they should immediately tell their doctors,     because it may be necessary to change the treatment.   "
192603|NCT00360100|"     Assess tolerability of different dosing formulations (adult versus pediatric).   "
192605|NCT00360139|"     Lipoatrophy is a condition that affects certain individuals, most commonly those who are     infected with the HIV virus. Lipoatrophy however can also affect individuals who suffer from     recurrent systemic infections, those who have a weakened immune system, or certain patients     who suffer from cancer or receive chemotherapeutics. In contrast, lipoatrophy can sometimes     be present in individuals who are perfectly healthy but have genetically predisposing factors     that can contribute to facial emaciation or lipoatrophy.      The function of injectable fillers for the treatment of dermal contour deformities is to     smooth dermal depressions formed by the loss of volume. These often elastic contour fillers     (also known as soft tissue augmentation devices) can correct hollowness around the eyes, add     fullness to thin lips, balance a disproportionate face or correct topographical anomalies.      This study aims to:        -  Objectively measure the improvement of contour-deformities after Sculptra™ injection          from baseline to study closure by utilizing the Primos™ photographic/topographical          measuring system.        -  Evaluate the efficacy, longevity and duration of volume-correction in subjects which are          both HIV positive and HIV negative.        -  Assess the safety of Scupltra™ dermal filler when used to correct volume deformities          caused by lipoatrophy in subjects that are HIV negative.   "
192606|NCT00360152|"     Sentinel lymph node biopsy (SLNB) has recently emerged as a less invasive alternative to     axillary lymph node dissection (ALND) in the treatment of breast cancer. However, SLNB has a     number of limitations, and we believe that alternative strategies for staging of the axilla     should be explored. The hypothesis of this proposal is that the combination of preoperative     high-resolution axillary ultrasound (AUS), fine needle aspiration biopsy (FNAB), and     molecular analysis using real-time reverse transcription-polymerase chain reaction (RT-PCR)     represents a viable, minimally invasive alternative to SLNB. We propose a prospective cohort     study to rigorously assess the diagnostic accuracy of molecular analysis of AUS-FNAB     specimens. The primary endpoint of this study is to determine the feasibility of AUS-FNAB and     real-time RT-PCR to predict the pathologic status of the axilla in a proof-of-principle     study. In the short term, validation of this innovative strategy is likely to reduce the     number of sentinel node procedures. In the long term, we believe that AUS-FNAB may ultimately     replace SLNB.   "
192607|NCT00360178|"     Recruiting in Germany only:      This study will evaluate the safety and efficacy of valsartan plus HCTZ in fixed dose     combination in hypertensive patients not responding to treatment with the free combination of     Candesartan plus HCTZ. In an optional extension patients with uncontrolled BP at the end of     the core study can be treated with valsartan plus HCTZ in fixed dose combination plus     amlodipine 5 mg for additional 4 weeks.   "
192608|NCT00360191|"     The purpose of this study is to determine if buspirone combined with motivational enhancement     therapy is effective in reducing marijuana use in marijuana-dependent adults.   "
192658|NCT00360867|"     This is an extension study to provide ongoing treatment with AMG 706 monotherapy for subjects     with solid tumors who have completed the planned duration of AMG 706 treatment on a separate     Amgen protocol and have been evaluated as having stable disease or better. Subjects who are     no longer eligible to continue AMG 706 treatment on a separate Amgen protocol (for reasons     other than AMG 706 intolerance), but who are receiving clinical benefit or have the potential     to receive clinical benefit from AMG 706 per the investigator are also eligible to     participate in this trial.   "
192609|NCT00360204|"     Because adherence to postnatal care guidelines across the United States (U.S.) is poor,     newborns and mothers often are placed at undue risk for adverse medical and social outcomes.     This study aims to evaluate an alternative model of care and improve healthcare delivery to     and reduce health disparities for well newborns and mothers after hospital discharge by     using single postnatal home nurse visits. The principal investigator has previously shown a     reduction in poor outcomes for infants who receive a home visit after discharge when studied     retrospectively. The proposed research will build on the previous study and prospectively     evaluate the impact of a single home nursing visit on morbidities and health disparities for     newborns and mothers in a randomized, controlled trial involving 1154 mother/infant     breastfeeding dyads. Home visits should guarantee detailed assessment during an at-risk     period of infancy and motherhood, where medical and social problems can be recognized,     anticipated, and/or treated, and can bridge the gap between hospital care and primary care.     The investigators' program, The Nurses for Infants Through Teaching and Assessment after the     NurserY (NITTANY) Initiative, also will consider the cost-effectiveness of home visitation     compared with guidelines-adherent outpatient clinic care.   "
192610|NCT00360217|"     This study will explore the ability of an algae (ocean plant) omega-3 fat supplement (DHA) to     reduce triglyceride levels in patients currently being treated with statin therapy (Zocor or     simvastatin, Lipitor or atorvastatin, Pravachol or pravastatin, Crestor or rosuvastatin,     etc.) for coronary artery disease(CAD)or risk equivalents (any of the following: heart     attack, post angioplasty or stent, post coronary bypass surgery, angina, vascular disease,     stroke or diabetes).      The rationale for the study is based around the finding that patients with CAD have an     approximately 20 % reduction in the risk of sudden death when treated with fish oil (DHA is     one of the ingredients in fish oil). In studies of statin-based therapies, it has been     observed that statins reduce the risk of coronary events 20-45%. There has not yet been     research trials exploring the combination of the two ingredients (i.e., DHA plus statin) in     patient treatment either to reduce recurrent cardiac events or to address another reported     finding of fish oils to lower triglyceride levels (triglyceride is a form of blood fat).     This research project will be a pilot project to assess the safety and effectiveness of DHA     add-on therapy in patients currently being treated with statins for CAD.      The study hypothesis is to test the effectiveness of DHA as compared to placebo to lower     triglyceride levels in the blood. This is a double-blinded randomized clinical trial.   "
192611|NCT00360230|"     This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines     administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian     children. The Protocol Posting has been updated in order to comply with the FDA Amendment     Act, Sep 2007.   "
192612|NCT00360243|"     This trial is designed to assess the safety and efficacy of flibanserin in the treatment of     premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard     diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.   "
192613|NCT00360256|"     The objective of this pilot study is to determine the genetic polymorphism rate of CYP450 2D6     and 2C19 metabolic enzymes in patients with significant adverse effects from antidepressants,     compared to a population of patients who had no significant adverse effects from     antidepressants metabolized by CYP2D6 and 2C19.      The hypothesis for the proposed research is that the rate of 2D6 and 2C19 alleles that are     associated with poor metabolizer status in the treatment-intolerant population will far     exceed the rate found in patient population who takes antidepressants without adverse     effects.   "
192614|NCT00360269|"     The aim of the study is to determine if atomoxetine treatment combined with motivational     enhancement therapy is effective in reducing marijuana use in adult individuals with     attention-deficit hyperactivity disorder and marijuana dependence.   "
192615|NCT00360282|"     The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers     motion sickness in migraine sufferers.   "
192616|NCT00360295|"     To evaluate the clinical efficacy and safety in patients with mild or moderate     community-acquired pneumonia receiving a dose of 2 g of azithromycin in the SR formulation.   "
192617|NCT00360308|"     Randomised, double-blind, double dummy, parallel group design. Following the screening period     patients will be randomised at the baseline visit, in a 1:1:1 manner, to one of three     treatment arms; 4 mg E2007, 200 mg entacapone (with each dose of levodopa) or placebo. The     first 4 weeks of the double blind phase will be used to titrate patients on the E2007 arm     from 2 mg up to the maintenance dose of 4 mg. Patients randomised to entacapone or placebo     will have dummy up titrations to maintain the blind. Following this titration phase, patients     will remain on the maintenance dose for a further 14 weeks.      Patients will have visits at 2, 4, 6, 10, 14 and 18 weeks after baseline. A follow up visit     will be performed at Week 22.      A home diary will be completed in which patients rate themselves as either:        1. OFF        2. ON without dyskinesias        3. ON with non-troublesome dyskinesias        4. ON with troublesome dyskinesias        5. Asleep      These entries will be completed every 30 minutes during the waking day and will be completed     for three consecutive days immediately prior to visits at Baseline, Weeks 6, 10, 18 and 22.      At Baseline (Day 0), week 10 and 18 the Unified Parkinson's Disease Rating Scale (UPDRS -     Parts I, II , III and IV) will be performed.      At the end of the treatment period (Week 18), patients will undergo final efficacy and safety     assessments and will stop taking the study medication they were receiving. They will be seen     4 weeks later for a follow up visit.   "
192630|NCT00360477|"     The patient will be asked to participate in a research project designed to determine the best     way to prevent bleeding and promote patient comfort after having kidney stones removed. Two     standard methods for ending the surgery are being compared to a newer method. In one standard     method, the patient will have a tube draining urine from the kidney after the procedure. This     tube may also prevent bleeding from the kidney. In another standard method the patient will     have a tube left internally that drains urine from the kidney to the bladder and a stitch     will be used to close the incision and deeper tissues in the back. In the third potential     option, a tube would be left internally to drain urine from the kidney to the patient's     bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is     a FDA approved agent specifically formulated to stop bleeding during surgical procedures.   "
192618|NCT00360321|"     International surveys about pathological gambling estimate that there are about 1 to 3 per     cent of gamblers who develop a pathological behavior about gamble.In France, pathological     gambling is not a priority of public health, in contrast with other addictive disorders, like     alcoholism or nicotine addiction. The aim of our study is to describe accurately for the     first time in France, a sample of “at risk” and pathological French gamblers. We want to     collect socio-demographical and clinical data from this subjects (story of the addictive     behaviour, co morbidities, and more specifically, detailed study of pathological gamblers’     personality), in order to compare our data with those of international     literature.Secondarily, we want to test the feasibility of this kind of detailed evaluations     for another study planned for 2007-2008 and which purpose will be to compare pathological     gamblers’ personality characteristics according to the kind of game that they mainly     practice.The participation at the study will be proposed to every patient consulting in the     “service d’addictologie du CHU de Nantes”. The study consists in a single evaluation (about 8     hours) with standardized tools used all other the world.   "
192619|NCT00360334|"     This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral     antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic     control, as measured by hemoglobin A1c, with minimum weight gain, in patients with     uncontrolled type 2 diabetes on OADs.   "
192620|NCT00360347|"     This study will investigate the efficacy, safety and pharmacokinetics of Mircera in adult     anemic patients with multiple myeloma. In the first stage of the study, patients will be     randomized to receive subcutaneous injections of Mircera once every 3 weeks, at doses of 2.0,     3.5 or 5.0 micrograms/kg. Following the administration of 2 doses, an evaluation of     hemoglobin increase will be made at week 6. In the second stage, further groups of patients     will receive additional doses of Mircera,at doses of 1.0, 6.5 or 8.0 micrograms/kg, depending     on efficacy, safety and pharmacokinetic considerations.The anticipated time on treatment is     3-12 months, and the target sample size is <100 individuals.   "
192621|NCT00360360|"     We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy     (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first     line treatment of patients with carcinoma of unknown primary site. There is limited     experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site     but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis     pathways and/or the EGFR pathway are effective strategies in at least a proportion.   "
192622|NCT00360373|"     The purpose of this research study is to find out what effects (good and bad) gastric bypass     has on metabolism, including pancreatic insulin secretion. In addition, we will compare the     effects of gastric bypass on the metabolism of adults and adolescents to try to determine     whether there are greater metabolic and health advantages of performing gastric bypass     earlier in life versus waiting until adulthood.   "
195589|NCT00407602|"     The objective of this feasibility study is to evaluate the safety and utility of the Argus II     Retinal Stimulation System in providing visual function to blind subjects with severe to     profound retinitis pigmentosa.   "
192625|NCT00360412|"     Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who     meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase,     lasting 4 weeks (weeks 0-3) followed by the Maintenance Phase, lasting 52 weeks (weeks 4-56).     All patients will receive active study drug. During the Titration Phase, patients will     receive E2007 2 mg once daily (o.d.) for 2 weeks followed by 4 mg o.d. for 2 weeks. During     the Maintenance Phase, patients will receive 4 mg o.d. Patients not tolerating the study drug     at 4 mg, will be allowed to down titrate to 2 mg. Patients not tolerating 2 mg will be     withdrawn from the study.      Patients will have visits at 2, 4, 8, 20, 32, 44, and 56 weeks after study entry. In     addition, a follow-up visit will occur 4 weeks after study treatment has ended (week 60).      A home diary will be completed in which patients rate themselves as either:        1. OFF        2. ON without dyskinesia        3. ON with non-troublesome dyskinesias        4. ON with troublesome dyskinesias        5. Asleep      These entries will be completed every half hour during the waking day and will be completed     for 3 consecutive days following the visits at weeks 4, 8, 20, 32 and 44, and three days     prior to the visits at weeks 56 and 60. At entry into the study (week 0) and at weeks 8, 20,     32, 44 and 56, the Unified Parkinson's Disease Rating Scale (UPDRS), Clinician's Global     Impression of Change (CGIC) and Clinical Global Impression of Tolerance (CGIT) will be     performed.   "
192626|NCT00360425|"     This study will define the effects of ferumoxytol on electrocardiogram (ECG) data as well as     evaluate pharmacokinetics   "
192627|NCT00360438|"     Primary      1. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with     leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS)      Secondary        1. To evaluate plasma uric acid AUC from baseline (within 4 hours prior to first          rasburicase treatment) through 48 hours after the last per-protocol planned          administration of rasburicase treatment;        2. To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma.        3. To evaluate incidence, duration, and type of immune responses (IgG, IgE, and          neutralizing antibody) to rasburicase.   "
192628|NCT00360451|"     This study will evaluate the effectiveness of the Penn Resiliency Program, a school-based     cognitive behavioral depression prevention program for young adolescents.   "
192629|NCT00360464|"     To evaluate the clinical efficacy and safety in patients with Acute Bronchitis or Secondary     Infection of Chronic Respiratory Diseases receiving a dose of 2 g of azithromycin in the SR     formulation.   "
192631|NCT00360490|"     The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine     system is effective in decreasing menstrual blood loss.   "
192902|NCT00371631|"     The purpose of the research is to determine whether we can get harmless bacteria to live in     the bladders of persons with spinal cord injury who practice intermittent bladder     catheterization. We will also look at whether having the harmless bacteria in the bladder     prevents urinary tract infections from occurring.   "
192632|NCT00360503|"     People with cystic fibrosis (CF) often develop chronic pulmonary infections which are caused     by a variety of organisms, the most predominant being Pseudomonas aeruginosa. Antibiotics are     important in managing CF lung infections. Antibiotic use in CF was altered about ten years     ago with the approval of inhaled tobramycin, an aminoglycoside which is effective in treating     P. aeruginosa. A decade later, CF clinicians are increasingly concerned about the likelihood     of induction of aminoglycoside-resistance with prolonged use of inhaled tobramycin to treat     chronic P. aeruginosa airway infections. The goal of this study is to examine the current     microbiology and susceptibility of organisms from CF sputum, correlate it with antibiotic     use, and compare it with previous data.   "
192633|NCT00360516|"     If eating a Paleolithic diet helps improve these diseases, this would be the first step in     both improving people's health as they get older as well as contributing to future national     dietary guidelines for Americans.   "
192634|NCT00360529|"     This trial is designed to assess the safety and efficacy of flibanserin in the treatment of     premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard     diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.   "
192635|NCT00360555|"     This trial is designed to assess the safety and efficacy of flibanserin in the treatment of     premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard     diagnostic criteria.      Efficacy for flibanserin will be assessed vs. a parallel placebo group.   "
192636|NCT00360568|"     Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.   "
192637|NCT00360581|"     The purpose of this study is to develop strategies to maintain smoking abstinence initiated     in pregnancy and prevent relapse in the postpartum period.   "
192638|NCT00360594|"     Acamprosate is approved by the Food and Drug Administration (FDA) for the treatment of     alcoholism. The purpose of this study is to see if initiating acamprosate early in alcohol     detoxification instead of waiting until detoxification has been completed effects the course     of detoxification, adverse events during detoxification, drop out rate during the     rehabilitative treatment phase, or overall efficacy of acamprosate for those with alcohol     dependence who plan to receive at least two months of rehabilitative pharmacotherapy with     acamprosate.   "
192639|NCT00360607|"     Intra-abdominal infections are often polymicrobial, and include aerobic as well as anaerobic     bacteria. Antibiotics used in intra-abdominal infections should aim to cover organisms such     as Enterobacteriaceae and Bacteroides fragilis, which are the commonest organisms known to     cause such infections. Combinations of a third-generation cephalosporin, an aminoglycoside     and metronidazole are often used to treat such infections in surgical settings. An     alternative to such combinations is the use of a beta lactam - beta lactamase inhibitor     combination. Magnex (cefoperazone- sulbactam) is one such combination, which has been shown     to be as effective as a standard multidrug regimen such as gentamicin and clindamycin in the     management of intra-abdominal infections. The combination of ceftazidime, amikacin and     metronidazole has been chosen as a comparator regimen because of its broad coverage of     Gram-negative and anaerobic organisms found in such conditions.   "
192640|NCT00360633|"     Parkinson's Disease (PD) is often thought of as affecting movement only. In fact, most     patients also experience psychiatric and cognitive symptoms, sometimes from the disease     itself, and sometimes as a side-effect of PD medications. The goals of this study are to     evaluate the causes, effects, and clinical correlates of psychiatric and cognitive symptoms     in PD.   "
192641|NCT00360646|"     The purpose of this study is to establish retrospectively a nationwide registry of patients     who have suffered drug-induced liver injury (DILI), and to collect, immortalize and store     serum, DNA, and lymphocytes from these patients. ILIAD will serve as a resource for     subsequent mechanistic investigations into the basis of severe idiosyncratic DILI. The     primary goal of the ILIAD protocol is to create: (a) a clinical database consisting of     individuals who have experienced severe DILI caused by four specific drugs, and the relevant     clinical data concerning the episode of DILI; and, (b) to create a bank of biological     specimens obtained from these individuals. These biological specimens will be DNA, plasma,     and immortalized lymphocytes. Immortalized lymphocytes will provide unlimited amounts of     genomic DNA for study as well as living immune cells for phenotyping studies. A secondary     goal of the ILIAD protocol is to maintain a registry of cases in the ILIAD database so that     they may be recontacted in the future. It is expected that this will facilitate additional     studies exploring the mechanisms of DILI.   "
192642|NCT00360659|"     We wanted to test the hypothesis that treatment with continuous positive airway pressure     reduces nocturnal hypoxia and thereby affecting levels of vasoactive hormones leading to a     fall in blood pressure patients with obstructive sleep apnea.   "
192643|NCT00360672|"     The goal of this clinical research study is to find out if Revlimid can help to control the     disease in patients with relapsed/refractory acute myelogenous leukemia (AML) or high-risk     myelodysplastic syndrome (MDS) with abnormalities in chromosome number 5. The safety of this     treatment will also be studied.   "
192644|NCT00360685|"     A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day     +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and     discontinued by day +180. In addition patients will be randomized to methotrexate (MTX) or     mycophenolate mofetil (MMF) and again, in the absence of GVHD, a tapering schedule will begin     on day +240 and be completed on day +360. Doses will be adjusted to maintain blood levels.   "
192645|NCT00360698|"     To evaluate the efficacy of a single injection of glulisine before the main meal added to     insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs     in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.   "
192657|NCT00360854|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     erlotinib together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when     given alone or together with radiation therapy in treating young patients with refractory or     relapsed malignant brain tumors or newly diagnosed brain stem glioma.   "
192986|NCT00365248|"     The overall objective is to assess the haemostatic efficacy and safety of TachoSil for     control of local bleeding in paediatric patients undergoing surgical resection of the liver     with our without segmental liver transplantation.   "
192646|NCT00360711|"     This study will examine the experience of moral value conflicts among genetic counselors.     Previous research has shown that value conflicts do exist among genetic counselors, but     little is known about the nature or consequences of these conflicts. This is a sub-study of     the Manifestations and Consequences of Moral Distress Among Genetic Service Providers: An     Exploratory Study, which includes genetic counselors, nurses and medical geneticists.      Genetic counselors are recruited for this value-conflict sub-study from among those     participating in the Moral Distress study. Participants are interviewed in-depth by telephone     about their experiences of moral value conflicts with clients. The interviews cover the     following: situations in which the counselor has disagreed with a client's decision or views     on a moral level; the counselor's thought processes during and after a session in which     conflicts arise; the counselor's feelings and emotions associated with sessions involving a     moral value conflict; the counselor's current and previous work settings; the counselor's     view of his or her role and responsibility in a client's decision; challenging a client's     values or decision; and preparation for value conflicts.   "
192647|NCT00360724|"     The investigators are studying a new antidepressant medicine, duloxetine, for the treatment     of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by     the FDA for the treatment of major depression. The investigators are testing whether this     medicine is also effective for adults with chronic depression (dysthymic disorder or     dysthymia).      Chronic depression, lasting two or more years, often causes significant suffering and     impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during     which half of the participants will take the new medication and half will take a placebo (an     inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin,     during which all subjects can be treated with an FDA-approved antidepressant medication.      Eligible subjects may also receive MRI scans, to help the investigators understand how     antidepressants work in treating depression.   "
192648|NCT00360737|"     The primary purpose of the study is to evaluate the safety of the 7 Botulinum Antitoxin     Serotypes derived from horses using various laboratory measurements, clinical examinations     and adverse events. In addition, following intravenous (injected into the vein)     administration assessing how much 7 Botulinum Antitoxin remains in the body.   "
192649|NCT00360750|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, etoposide, and     cytarabine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     tumor cells. Giving chemotherapy with or without radiation therapy after surgery may kill any     tumor cells that remain after surgery. Sometimes, after surgery, the tumor does not need more     treatment until it progresses. In this case, observation may be sufficient.      PURPOSE: This clinical trial is studying how well chemotherapy with or without radiation     therapy or observation works in treating young patients with advanced retinoblastoma who have     undergone surgery to remove the eye.   "
192650|NCT00360763|"     The autoantibodies against AT1 receptor (ATR-AA), behaving like an agonist were detected in     patients with hypertension. ATR-AA which can blocked by ARB may play a role in the     pathogenesis of hypertension. The present study is to explore whether AT1 receptor blocker     has superior anti-hypertensive effect in patients with positive ATR-AA hypertension. Patients     with 2 grade hypertension were recruited and ATR-AA was assayed by ELISA. A study was carried     out and the efficacy of anti-hypertension was compared between candesartan cilexetil and ACE     inhibitor imidapril.   "
192653|NCT00360802|"     The primary purpose of this study is to determine the effectiveness of two psychological     techniques in chronic low back pain patients treated in hospital pain clinics. The techniques     are: cognitive behavioral treatment and mindfulness based stress reduction (MBSR). This is a     multiple site project in which patients come from 16 different pain clinics throughout Spain.     The control group is formed by patients under usual medical treatment at pain clinics. The     two intervention groups also receive usual medical treatment at pain clinics plus one     psychological therapy treatment. The sample size is 330 subjects.   "
192654|NCT00360815|"     Background. Long-term microvascular and neurologic complications cause major morbidity and     mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether     intensive treatment with the goal of maintaining blood glucose concentrations close to the     normal range could decrease the frequency and severity of these complications.      Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the     primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort)     were randomly assigned to intensive therapy administered either with an external insulin pump     or by three or more daily insulin injections and guided by frequent blood glucose monitoring     or to conventional therapy with one or two daily insulin injections. The patients were     followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other     complications were assessed regularly.   "
192655|NCT00360828|"     Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at     each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine.      At each cycle, patient exams and interviews as well as lab results were to help the research     team to determine the symptomatic side effects of the treatment. Recorded past toxicities     were to be compared with current side effects.   "
192656|NCT00360841|"     The purpose of this study is to evaluate auricular acupuncture as an antiemetic treatment     compared with sham acupuncture and with no acupuncture in patients receiving moderately-high     to highly emetogenic chemotherapy. Acupuncture constitutes a nonpharmacological intervention     for chemotherapy-induced nausea/vomiting (CINV). Chinese medicine holds that stimulating     select points both on the body and the ear, that lie along meridians or life channels, can     relieve diseases.   "
192659|NCT00360893|"     OBJECTIVE— The Diabetes Control and Complications Trial (DCCT) demonstrated the powerful     impact of glycemic control on the early manifestations of microvascular complications.      Contemporary prospective data on the evolution of macrovascular and late micro vascular     complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and     Complications (EDIC) study is a multicenter, longitudinal, observational study designed to     use the well-characterized DCCT cohort of 1,400 patients to determine the long-term effects     of prior separation of glycemic levels on micro- and macrovascular outcomes. EDIC is in its     13th year of followup. The study is expecting to last until 2016.      RESEARCH DESIGN AND METHODS— Using a standardized annual history and physical examination, 28     EDIC clinical centers that were DCCT clinics will follow the EDIC cohort for 10 years. Annual     evaluation also includes resting electro c a rdiogram, Doppler ultrasound measurements of     ankle/arm blood pressure, and screening for nephropathy. At regular intervals, a timed 4-h     urine is collected, lipid pro files are obtained, and stereoscopic fundus photographs are     taken. In addition, dual B-mode Doppler ultrasound scans of the common and internal carotid     arteries will be perf o rmed at years 1 and 6 and at study end.   "
192660|NCT00360906|"     Based on previous clinical studies indicating beneficial treatment effects of omega-3 fatty     acids in multiple sclerosis, and the increasing evidence of anti-inflammatory effects of     omega-3 fatty acids, this study aims to evaluate treatment effects of concentrated omega-3     fatty acids (Triomar™) in MS, both as monotherapy and in combination with standard     immunomodulatory therapy defined as interferon-beta 1a (Rebif™).   "
192661|NCT00360919|"     This purpose of this study is to perform a pilot investigation to determine if opioid     peptides such as casomorphin can be detected in human plasma after cheese ingestion.   "
192662|NCT00360932|"     5 year, open-label study to evaluate safety of SCULPTRA on the signs of lipoatrophy of the     face in at least 100 evaluable subjects with human immunodeficiency virus.   "
192663|NCT00360945|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide     works in treating young patients with malignant glioma.   "
192664|NCT00360958|"     Patients with severe congestive heart failure show increased fluid body content which is     often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients     have frequent access to the emergency room and hospital for hemodynamic instability.     Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The     purpose of this study is to determine whether periodic ultrafiltration sessions maintain     patients in stable clinical condition and reduce hospitalisations as well as access to     emergency heart failure treatment.   "
192665|NCT00360971|"     RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth     sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It     is not yet known whether palifermin is more effective than a placebo in lessening mucositis     in patients receiving radiation therapy and chemotherapy for head and neck cancer.      PURPOSE: This randomized phase III trial is studying palifermin to see how well it works     compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy     and chemotherapy for locally advanced head and neck cancer.   "
192685|NCT00361231|"     The purposes of this study are to test the safety of bevacizumab when given in combination     with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has     on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or     stop cell growth in tumors by decreasing the blood supply to the tumors.   "
192686|NCT00361244|"     The purpose of this study is to determine the safety of SU011248 and the highest dose of this     drug that can be given safely in combination with the chemotherapy drugs irinotecan and     cetuximab. Laboratory studies have shown that SU011248 may block the growth of blood vessels     in tumors, which may prevent tumors from growing any further. Other studies have demonstrated     the possibility that SU011248 may enhance the anti-tumor activity of other chemotherapy drugs     such as irinotecan and cetuximab.   "
192666|NCT00360984|"     Severe hypoglycaemia leading to collapse without warning is one of the most-feared     complications for those with Type 1 diabetes. The aim of this study is to determine whether     detection and targeted prevention of hypoglycaemia by using either an optimised subcutaneous     insulin regime or continuous insulin regime can restore hypoglycaemia awareness in Type 1     diabetes. Following a 6-day continuous subcutaneous monitor glucose profile, participants     will be randomised to 1 of 3 interventions: rigorous avoidance of hypoglycaemia on current     insulin regime; targeted optimisation of subcutaneous insulin regime to avoid hypoglycaemia;     or continuous subcutaneous insulin infusion. Symptomatic experience and severity of     hypoglycaemia, pattern of hypoglycaemia on glucose profiling and, in selected individuals,     response to hyperinsulinaemic hypoglycaemic clamp, will be compared over a 6 month period. It     is envisaged that successful prevention of hypoglycaemia by one or more interventions may     reverse altered hypoglycaemia awareness and prevent further episodes of severe hypoglycaemia.   "
192667|NCT00360997|"     The purpose of this study is to find which of three doses of mobilisation and tactile     stimulation therapy, when given in addition to conventional UK physical therapy, has the most     beneficial effect on enhancing motor recovery of the upper limb early after stroke.   "
192668|NCT00361010|"     Childhood absence epilepsy (CAE) is a form of generalized epilepsy syndrome. Clinically these     seizures are manifest with a sudden, brief (3-15 second) loss of awareness followed by a     quick recovery to baseline. Keppra (levetiracetam) is approved by the U.S. Food and Drug     Administration (FDA) to treat partial seizures in adults. It is currently being studied in     children with partial seizures. Absence seizures can be difficult to detect clinically,     therefore the response to therapy will be determined both by clinical observation and by 24     hour EEG recordings. The researchers hope that with this information they will learn how well     it works for the treatment of childhood absence epilepsy and at what dose. This is an     open-label, dose-ranging pilot study of levetiracetam in subjects with newly diagnosed     childhood absence epilepsy. Approximately 20 patients will be needed to study effectiveness     and dose requirements. Subjects must not be on any antiepileptic medication at the time of     entry into the study. Male and female subjects from the ages of 4 to 10 years of age may     participate.   "
192669|NCT00361023|"     Angiotensin type-1 receptor (AT1R) blockers (ARBs) have been recognized recently as     regulators of glucose and lipid metabolism in adipocytes and adipose tissue.Moreover     telmisartan and irbesartan have been recognized recently as regulators of glucose metabolism.     For ARB losartan, the results were controversial. To confirm its effect on glucose     metabolism, we designed and performed a prospective, randomized and controlled study in     subjects with type 2 diabetes and nephropathy.   "
192670|NCT00361036|"     A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in     the treatment of uterine fibroids by embolization with respect to clinical & imaging outcome     with comparison of primary safety endpoints to Embosphere.   "
192671|NCT00361049|"     RATIONALE: Donor mesenchymal stem cell infusion may be an effective treatment for acute or     chronic graft-versus-host disease caused by a donor stem cell transplant.      PURPOSE: This phase I trial is studying the side effects and best dose of donor mesenchymal     stem cells in treating patients with acute or chronic graft-versus-host disease after     undergoing a donor stem cell transplant.   "
192672|NCT00361062|"     SSRIs are the first line of therapy for anxiety and depressive disorders and for many other     clinical diagnoses. One of the most disturbing side effects that is observed is a tendency     towards aggressiveness among patients receiving medications from this group, mainly during     the first month of therapy. Aggressive behavior tends to occur in some individuals but not in     others. In some sub-groups of people, personality and character traits might make a person     more prone to aggressive behavior.      In this study the investigators try to estimate the tendency towards aggressive behavior in     patients prescribed to a medication from the SSRI group. By using a comparative computer     simulation they hope to be able to detect delicate changes and to maybe get some clues of the     personalities prone to aggressive behavior in the future.   "
192673|NCT00361075|"     The postmenopausal state is associated with an increase risk for heart disease. Much of this     increase in risk may be due to the loss of estrogen (the main female hormone) and the effect     of this loss on lipids (blood fats). This loss of estrogen is often treated by estrogen     replacement therapy. Estrogen replacement therapy seems to have a beneficial effect on lipid     levels. The purpose of this research study is to understand 1) how menopause affects lipids     and 2) how hormone replacement therapy effects the lipid metabolism of postmenopausal women.   "
192674|NCT00361088|"     In Phase I, patients will receive a combination of PS-341 (Velcade) and R115777 (Zarnestra)     to determine the dose limiting toxicity (DLT). Once DLT is determined, patients in Phase II     will be receive the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment     will continue if there is evidence of continued response for 8 cycles. Patients will receive     follow up to include normal laboratory evaluations at least every 3 months and a skeletal     survey will be performed at least every 6 months.   "
192675|NCT00361101|"     The purpose of this study is to determine the safety and activity of AMD11070 in HIV-infected     patients carrying X4-tropic virus.   "
192687|NCT00361257|"     The purpose of this study is to determine the effectiveness of minocycline, an antibiotic, in     lessening the decreased mental function sometimes caused by anti-HIV drugs.   "
192688|NCT00361270|"     The purpose of this study is to assess the effectiveness of hypnosis in the treatment of     chronic low back pain.   "
192689|NCT00361283|"     The purpose of the study is to test whether atorvastatin (also known as Lipitor) has     anti-inflammatory effects in people with no known heart disease or high cholesterol. We also     are investigating whether or not genetic differences between people plays a role in the drug     response.   "
192690|NCT00361296|"     RATIONALE: Vaccines made from cancer cells may help the body build an effective immune     response to kill abnormal cells.      PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients     with myelodysplastic syndromes (MDS).   "
192691|NCT00361309|"     The main purpose of this study is to begin to collect information and try to learn whether     SU011248 works in treating patients with advanced liver cancer. Laboratory studies have shown     that SU011248 may block the growth of blood vessels in tumors, which may prevent tumors from     growing any further.   "
192676|NCT00361114|"     Intermittent Preventive Treatment of malaria in infants is a promising strategy to reduce     incidence of clinical malaria in children under the age of 1 year. It is likely to be     implemented as a malaria control strategy in Tanzania using sulfadoxine/pyremethamine SP. SP     is failing as a first line treatment for clinical episodes of malaria and government policy     is driving a change to use Artemesin Combination Therapy (ACT). The main ongoing Kilimanjaro     IPTi study is looking at alternatives to SP for use in IPTi. Currently, as there is no     evidence for the use of other drugs for IPT, SP will be continued for IPT in pregnancy and in     infants. This study proposes to measure the efficacy of SP and chlorproguanil/dapsone (CD),     in symptomatic 6- 59 month old children using standard methodology. These are both study     drugs in the main IPTi study. This will help us to see how the efficacies of SP and CD in     sick children relate to the efficacies for treating asymptomatic children with IPTi. In     addition this proposal aims to test the efficacy of SP given to 2-10 month old asymptomatic     infants (the target group for IPTi). Evidence suggests that asymptomatic malaria infections     with low parasitaemia have a higher cure rate than symptomatic infections with high     parasitaemia even when markers of resistance are highly prevalent. This second study aims to     quantify this difference and will produce evidence to help policy makers know when drugs used     for IPTi should be changed. Both studies will be open label and run concurrently in Hale,     Korogwe district near to the main Kilimanjaro IPTi site in Tanzania.   "
192677|NCT00361127|"     In patients with chronic heart failure ACE-inhibitor treatment improves lung diffusion and     prevents pulmonary edema after fluid overload. In the western country, 3 population types of     ACE genotypes exist (DD, ID, II). It is unknown whether the ACE genotype influences the     response to fluid overload in ACE-inhibitor treated chronic heart failure patients.   "
192678|NCT00361140|"     Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6,     -5, -4, and -3. Daily treatment doses will be adjusted to achieve target area under the     plasma concentration time curve (AUC). Day 0 is the day of hematopoietic progenitor cell     reinfusion. Supportive care will be based on institutional guidelines. Blood samples will be     collected for dose modification based on the AUC levels. Dose escalation will proceed to     determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit     of higher doses of busulfan.   "
192679|NCT00361153|"     This study is designed to test whether WelChol (colesevelam HC1) improves blood sugar control     in patients with type 2 diabetes by making their own insulin work more efficiently.   "
192680|NCT00361166|"     The primary purpose of this study is to determine whether a combination of ACP-103 (the study     medication) with either haloperidol or risperidone will show antipsychotic efficacy and that     it is safe and well tolerated. Further purposes of this study are to determine whether     ACP-103, in combination with either haloperidol or risperidone, will enhance their     antipsychotic effectiveness, demonstrate effectiveness against the negative symptoms, improve     motoric tolerability, and is safe and well tolerated.      This is a seven-week study (one week screening and six weeks of study medication) where a     total of 400 patients who meet entrance criteria will randomly be assigned to receive one of     five groups of study treatments of either low dose haloperidol plus ACP-103, low dose     haloperidol plus placebo (a substance similar to a sugar pill), low dose risperidone plus     ACP-103, low dose risperidone plus placebo, or high dose risperidone plus placebo. The study     will begin with with a three to seven day drug-free period followed by six weeks of a stable     daily dosage of study medication. Study subjects will be treated as hospital in-patients     during screening and for the first 14 days of the study. Study subjects will be closely     monitored throughout the study.   "
192723|NCT00361725|"     This is a comparative study performed in 3 groups of patients/subjects: 30 severe sepsis     patients, 30 non-septic patients with organ failure, 30 healthy subjects.      The only intervention is a venous blood sampling at the onset of the disease.      The purpose of the study is to compare the PC pathway and expression and inflammatory genes     between the 3 groups. The main hypothesis is that systemic inflammatory response and     exacerbated coagulation activation are non specific of an infection as a triggering event.   "
192681|NCT00361179|"     Chronic hepatitis C may relapse in simple chronic hepatitis C patients who initially obtained     sustained virologic responses. Although the HCV SVR could be maintained in around 90%, the     remaining 10% of these patients may develop hepatitis C relapse during follow-up. Therefore,     it is important to follow up the long-term of these patients with dual chronic hepatitis B     and C.      From another aspect, for the treatment of chronic hepatitis B, the virologic and serologic     responses may also not be durable. Alternatively, previous studies suggested that the     therapeutic efficacy might not be seen in the study period, and incremental response might     occur during long-term follow-up. Therefore it is also important to clarify the long-term     outcome of treatment in this dually infected population.      Evaluation of the long term effects of treatment with peginterferon alfa-2a plus ribavirin     for patients with chronic hepatitis C/ hepatitis B co-Infection and chronic hepatitis C in     the original study ML17862 is important. This present protocol is thus to assess whether the     HCV SVR is sustained and to assess the durability of the HBV virologic and serologic     responses or any incremental response during a 5-year follow-up period, including six months     after end of the therapy in the original study and an additional 4 and half years in this     project (5 years overall follow-up after the end of treatment). Specifically, we wish to     assess the (1) sustained virologic response (SVR) of HCV in both populations, (2) incidence     of HBsAg loss and HBsAg seroconversion (HBsAg loss and appearance of anti-HBs) in dually     infected population, (3) ALT normalization or flare off-treatment during both populations,     (4) reductions of HCV RNA from the original baseline levels in the two patient populations,     and (5) reduction of serum HBV DNA off-treatment in the dually infected population.   "
192682|NCT00361192|"     Introduction      Temporal arteritis (TA) is the most common primary vasculitis in the adult population. TA is     a systemic multi-organ disease but primarily involves the cranial arteries, especially the     temporal artery. The signs and symptoms of the disease are variable and therefore the     differential diagnosis is often difficult. The annual incidence of the disease in the     population above the age of 50 in Jerusalem is about 10 per 100,000.      Diagnosis is based on the clinical findings and confirmed by biopsy of the temporal artery,     positive for histologic findings of arteritis. Though the biopsy procedure is minor and can     be accomplished under local anesthesia, it is not without morbidity. Along with minor pain,     more serious complications - facial nerve injury, ptosis, stroke, and local necrosis of skin     - have been reported.      A negative biopsy does not completely rule out the diagnosis of TA because of the segmental     nature of the inflammation. Even if one removes an appropriate length of artery (usually 1-2     cm) the possibility exists that an involved segment may not have been included and the biopsy     will be reported as normal.      It has recently been reported that color Doppler ultrasonography can be used to diagnose TA.     Arterial inflammation causing peri-vascular edema appearing as a dark halo and segmental     stenosis of the temporal artery are characteristic ultrasound findings suggestive of TA. If     there is no dark halo sign, a diagnosis of TA cannot be supported and temporal artery biopsy     can be avoided in most of these patients. The presence of the dark halo sign has a positive     predictive value of only 50%.      As noted above the disease is characterized by segmental involvement of the artery and to     avoid a false negative biopsy, excision of up to 3cm of the artery has been recommended,     thereby increasing the morbidity, and leading patients to refuse the procedure. Use of     ultrasound-guided biopsy of the artery may dramatically raise the sensitivity and specificity     of the biopsy and reduce the requirement for excising long segments of artery.      Objective      The objective of this study is to examine the use of ultrasound-guided biopsy of the temporal     artery in the diagnosis of TA. Ultrasound-guided biopsy will be compared to the standard     random biopsy generally in use. Appropriate statistical methods will be employed.      Methods      The Vascular Laboratory in Shaare Zedek Medical Center performs approximately 200 Doppler     ultrasound studies of the temporal artery each year at the request of community-based     physicians. Some of these patients are then also referred for biopsy of the temporal artery     at various surgical facilities in the city. In collaboration with the referring physician,     the patients will be offered a combined diagnostic Doppler ultrasound and guided biopsy on     the basis of clinical guidelines and according to the ultrasound findings as described below.      Patients suffering from signs and symptoms consistent with TA and who have not undergone     previous temporal artery biopsy will be included.      Patients suffering from isolated polymyalgia rheumatica will be excluded. Patients who are     already undergoing steroid treatment will be excluded. Patients with an ultrasound study that     is positive for the dark halo sign will be divided into two groups on a random basis after     obtaining informed consent.      One group will undergo ultrasound-guided biopsy, while the other will undergo biopsy as is     the standard practice in our institution - a 1-2cm length of temporal artery will be excised     from the preauricular area.      If the ultrasound is negative, no biopsy will be done in the setting of this study.      It is expected that about 50 patients will be accrued during the 6-month study period.     Differences in outcome will be analyzed using Fishers exact test.      Approval from the Helsinki committee of Shaare Zedek Medical Center has been requested.   "
192683|NCT00361205|"     Patients with Parkinson's Disease (PD) depend on medication for relief of motor symptoms, and     for this reason are often assumed to medicate very carefully. Overall, medication adherence     is very good, but a subset of 15 to 20% of cases take less than 80% of the total prescribed     dose. However, irregular timing of drug ingestion is almost universal, perhaps contributed by     fluctuating symptoms and drug regimen complexity. Pulsatile dopaminergic stimulation in the     basal ganglia is implicated in the development and manifestation of motor complications of     advancing PD. Irregular medication intake is likely to contribute to peaks and troughs in     serum and brain drug levels. In other diseases, patient adherence to prescribed medication     improves through simplifying drug regimens, providing additional education, counselling and     behavioural approaches and providing reminder packaging. We tested the effect on the timing     of medicine ingestion of an educational approach, in which patients were given detailed     additional information about the continuous dopaminergic theory.   "
192684|NCT00361218|"     The purpose of this study is to find out if two tests are useful in predicting whether     someone with depression will get better when he or she is treated with an FDA approved     antidepressant medication (either citalopram or escitalopram).   "
192692|NCT00361322|"     The concept behind our study was to combine an effect of antibiotic and anti-inflammatory     agents for a more efficient acne therapy directed at the factors involved in the     pathophysiology of the disease. For this purpose we evaluated a combination of clindamycin     phosphate and salicylic acid in a non-irritating carrier.   "
192693|NCT00361335|"     The purpose of this study is to assess the clinical effectiveness and safety of golimumab     intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with     MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX     treatment. In addition, the safety of subcutaneous (SC) golimumab injections following     transition from IV golimumab infusions will also be evaluated.   "
192694|NCT00361348|"     The purpose of this study is to determine if Paliferim interacts with Heparin.   "
192695|NCT00361361|"     The purpose of this study is to determine whether 308nm Excimer Laser therapy are effective     in the color correction of white striae.   "
192696|NCT00361374|"     This study examines the difference in the effectiveness of two natural compounds,     eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major     depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is     believed that a deficiency in these omega-3 fatty acids may lead to the development of major     depression.   "
192697|NCT00361387|"     Patients diagnosed with chronic sarcoidosis with fatigue for more than 6 months. Sarcoidosis     and its treatment can greatly affect your quality of life. Many patients suffer from fatigue     (feeling tired), lack of focus and concentration, in ability to organize their daily     activities, and memory loss. These commonly reported symptoms often get in the way of     everyday life.   "
192698|NCT00361400|"     This study is an examination of high risk young women, 15-24 years of age, who initiate     first time use of vaginal ring, oral contraceptives, contraceptive path, or Depo-provera.   "
192903|NCT00371644|"     The purpose of this study is to evaluate the effectiveness of Cognitive Processing Therapy     (CPT) versus Present-Centered Therapy (PCT) in treating current post-traumatic stress     symptoms associated with sexual assault that occurred while veterans were serving in the     military.   "
192699|NCT00361413|"     Alefacept (AMEVIVE®) is an immunosuppressive dimeric fusion protein. It was shown to     interfere with lymphocyte activation by specifically binding to the lymphocyte antigen, CD2,     and inhibiting LFA-3/CD2 interaction. Alefacept was evaluated in two randomized,     double-blind, placebo-controlled studies in adults with chronic (>1 year) plaque psoriasis     and a minimum body surface area involvement of 10% who were candidates for or had previously     received systemic therapy or phototherapy. The response to alefacept was significantly better     in both studies. In both studies, onset of response to alefacept treatment (defined as at     least 50% reduction of baseline Psoriasis Area and Severity Index (PASI)) began 60 days after     the start of therapy.      Graft versus host disease (GVHD) is the most ominous side effect of allogeneic stem cell     transplantation (SCT). It causes severe inflammatory process, which is usually located to the     skin, gut and liver. Treatment of GVHD consists of various immuno-suppressive and     immuno-modulating drugs, including steroids, cyclosporine, tacrolimus, methotrexate etc.     These drugs unfortunately can also cause severe immunologic failure that makes the patient     prone to infection and malignancy, and other medication-specific side effects. In spite of     this effect on the immune system, not all of the patients achieve control of GVHD, which     usually rapidly leads to death. Despite the use of innovative immunosuppressive modalities,     the prognosis of steroid resistant GVHD is usually poor.      It was shown that CD2 depletion of allografts could prevent GVHD. Alefacept was never     systemically tried in GVHD but A phase II study of BTI-322, a rat monoclonal IgG2b directed     against the CD2 antigen in steroid-refractory acute GVHD showed a total response rate of 55%.     We showed that alefacept might have a beneficial effect in controlling steroid resistant     aGVHD and chronic GVHD. It was also shown to dramatically change the nature of transfusion     associated GVHD.   "
192700|NCT00361426|"     Continuous measurement of breathing patterns, heart rate, restlessness and cough in sleep     using EarlySense ES 16 device. Predicting worsening in COPD patients' condition using the     above parameters.   "
192701|NCT00361439|"     People with allergies frequently complain of a loss or reduction in the sense of smell.      In this study, the investigators propose to perform a randomized, double blind, placebo     controlled parallel study of subjects with nasal allergies and decreased smell to determine     the effect of a treatment for allergies on the sense of smell.   "
192702|NCT00361452|"     Bronchiolitis is a common disease of infancy and a main reason for infants' hospital     admissions in the first 2 years of life. The main cause of bronchiolitis is RSV (respiratory     syncytial virus). Though, Treatment is mainly supportive, the treatment benefit of nebulized     epinephrine or albuterol has been largely debated for the past years. Most of the clinical     studies used clinical parameters to detect and compare the effectiveness of such medical     interventions. In this study we will use non invasive computerized method of wheeze and     crackles quantification to compare the effectiveness of nebulized epinephrine vs albuterol in     RSV Bronchiolitis.   "
192703|NCT00361465|"     Dystonia is a rare disease leading to a severe handicap. It can be of primary or secondary     origin. It is characterized by sustained muscle contractions, frequently causing twisting and     repetitive movements or abnormal postures. These disorders are believed to be caused by some     dysfunction of the basal ganglia (BG) circuitry, but the mechanisms are largely unknown.      A better understanding of the disorder requires significant improvements of its     phenomenological description in relation to aetiology. We want to identify specific motor     signatures of different forms of dystonia. To that aim, we will ask patients to perform     movements of various complexities, while recording chronometric, kinematics and EMG data. The     characteristics of the patients' movements will be compared to those of matched control     subjects. We will examine abnormal co-activation in distal and proximal muscles to evaluate     the characteristics of the loss of selectivity of the motor command in mobile vs. fixed     dystonia. Consistency of the motor output patterns will be compared in three groups of     patients. We will also study possible cognitive and limbic components of the disease,     examining the influence of cognitive and emotional loads on movement production. Eventually     we want to refine the criteria used to classify different forms of the disease, thus enabling     clinicians to better predict the likely outcome of particular therapeutic procedures.   "
192729|NCT00368121|"     EMMA-1 is an open-label, non-randomized, two-stage phase II study. Patients with refractory     multiple myeloma stage II or III or relapsed disease after at least one line of treatment     will receive Cetuximab+/-Dexamethasone.      The planed treatment duration per patient is 16 weeks. Patients achieving a response or     stable disease after 16 weeks of treatment may continue study medication for 6 more months     (patients receiving Cetuximab alone) or for 3 more months (patients receiving Cetuximab plus     Dexamethasone). Responding patients who relapse during follow-up period of two years may     receive a second treatment with Cetuximab following initial study guidelines   "
192704|NCT00361478|"     The study investigates the effect of the 'Mother and Baby' (M&B) program on the psychological     health and well-being of new mothers 6-10 weeks following the birth of their baby. The M&B     program is an 8-week program of group exercise and education sessions provided by various     health professionals. The design of the study is a comprehensive cohort design, including a     randomised controlled trial. The primary outcome measure is the Affect Balance Scale. The     hypotheses are:        1. The M&B program has a positive effect on new mothers' psychological health and          well-being.        2. The M&B program increases participation in regular physical activity.        3. the M&B program benefits first time mothers more than women who have had more than one          child.   "
192705|NCT00361491|"     The purpose of the study is to evaluate the efficacy of SSR149415 in the treatment of Major     Depressive Disorder, defined as a change from baseline to visit 7 in the Hamilton Depression     Rating Scale.      To evaluate the tolerability, safety and efficacy on disability and quality of life in     patients with major depressive disorder.To evaluate plasma concentrations of SSR149415.   "
192706|NCT00361504|"     The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at     doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients     with at least a 3-month history of low back pain, or pain caused by knee or hip     osteoarthritis.   "
192707|NCT00361517|"     Chemotherapy lowers the white blood cell count or weakens the immune system for a long time.     This puts the patients at a high risk of getting a serious fungal infection of the internal     organs or blood. One of these infections is caused by a mold called Aspergillus and can be     life threatening. Usually doctors give preventive antifungal therapy to try to lower the risk     of this infection. Despite this, patients are still at risk of getting fungal infection. This     study is thus designed to test Galactomannan - a component of cell wall of Aspergillus and     hence detect and treat fungal infection early.   "
192708|NCT00361530|"     Carotid ultrasound can reveal the intima-media complex thickness(IMT), that has been reported     to be a marker of atherosclerosis as well as a risk of cardiovascular events, and to be     attenuated by 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins)     . This substudy of J-STARS will observe the temporal profile of carotid IMT prospectively in     the patients with prescription of pravastatin and the control.   "
192724|NCT00361738|"     Dose-ranging study of AVE2268 in the management of patients with type 2 diabetes mellitus     also receiving metformin.      Its main objectives will be to assess the effects of several doses of AVE2268 on Mean Plasma     Glucose. Its secondary objectives will be to assess the effects of AVE2268 on plasma glucose     (fasting and post-prandial), and also the safety and tolerability of AVE2268.   "
192709|NCT00361543|"     The aim of the project is to investigate the use of Raloxifene (a new form of estrogen) in     the treatment of women with schizophrenia and schizoaffective disorder. Raloxifene is a     Selective Estrogen Receptor Modulator (SERM), which means that it can affect the central     nervous system (CNS) effects of estrogen (eg. improving emotional symptoms, memory,     information processing and concentration), without adversely affecting reproductive     tissue/organs such as breast, uterus and ovaries. The investigators are conducting a     double-blind, placebo controlled, three month study comparing the psychotic symptom response     of women with schizophrenia in both groups. One group will receive standard antipsychotic     medication plus 120mg Raloxifene, while the second group will receive standard antipsychotic     medication plus oral placebo.      Hypothesis 1: That the women receiving adjunctive Raloxifene would have a quicker recovery     from psychotic symptoms, as measured on the rating scales, compared with the women receiving     adjunctive placebo.      Hypothesis 2: That the Raloxifene group would have better cognitive improvement than the     placebo group.   "
192710|NCT00361556|"     The primary purpose of this study is to compare the effectiveness on the disability of low     back pain patients of The Back Book, The Back Guide, and a control intervention (generic     recommendations on general health). Patients are divided into 3 groups:those who receive The     Back Book (classic education), those who receive The Back Guide (cognitive behavioral     education) and the control group). They are patients who consult a physician at the primary     care consults of 14 different Health Centers in Spain. The sample size is 240 subjects.   "
192711|NCT00361569|"     This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to     compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream     on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or     oophorectomy.   "
192712|NCT00361582|"     The purpose of this study is to evaluate in patients who are eligible for elective primary     total or partial joint replacement of the hip or knee due to chronic osteoarthritis the     efficacy (level of pain control) of CG5503 over 5 and 10 days compared with placebo, and to     assess the safety and tolerability of multiple doses of CG5503 IR patients.   "
192713|NCT00361595|"     The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone     mass after two years of treatment with Forteo, in postmenopausal women.   "
192714|NCT00361608|"     This study observes the continuous measurement of breathing patterns, heart rate,     restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the     management of hypoglycemia in pediatric type I diabetes patients.   "
192715|NCT00361621|"     The main purpose of this study is to begin to collect information and try to learn whether or     not VELCADE, when added to standard chemotherapy with CHOP/Rituxan, works in treating     patients mediastinal large B-cell lymphoma. Recent research has shown that this type of     lymphoma shares features with Hodgkin's lymphoma, including the importance of a particular     pathway in the tumor cells called the NF-kB pathway. VELCADE works in part by blocking this     pathway.   "
192716|NCT00361634|"     The purpose of this study is to assess whether DCE-MRI can detect changes of active disease     in rheumatoid arthritis (RA) patients after 4, 8 and 12 weeks of etanercept.   "
192730|NCT00368134|"     This study is designed to evaluate the efficacy, safety and tolerability of vildagliptin     compared to voglibose in patients with type 2 diabetes. Please note this study is not being     conducted in the United States.   "
192731|NCT00368147|"     The purpose of this study is to determine if the creation of a fistula or a graft plays a     role in the development of heart disease for patients undergoing hemodialysis   "
192732|NCT00368160|"     Male and female healthy volunteers. Patients must also possess a full current driving license     (for at least one year), and be a regular car driver.   "
192717|NCT00361647|"     Prospective controlled randomized study. Aim of this study is to assess the feasibility and     sensitivity of CT scanning of the thorax, abdomen and pelvis for the detection of occult     cancer in patients with idiopathic venous thromboembolism. Patients presenting with acute     idiopathic venous thromboembolism, free from already known cancer and in whom a routine     battery screening has excluded the presence of cancer, are randomized to receive either a CT     scanning of the thorax, abdomen and pelvis (completed by mammography if not already performed     in the past year, and by gastroscopy and/or colonoscopy in patients with positive hemoccult)     or a diagnostic programme freely decided by attending physicians. Patients of either group in     whom the search for cancer is negative are followed-up for two years to register the     development of clinically symptomatic malignant disease. The rate of cancer detection and     that of cancer development are compared between the two study groups.   "
192718|NCT00361660|"     The first purpose of this study is to determine how often people should practice motor skills     to best improve the ability to use the affected arm and hand after stroke. The second purpose     is to determine whether it is better to practice a lot of repetitions of a few tasks or a few     repetitions of many tasks during motor rehabilitation for the arm and hand after stroke.   "
192719|NCT00361673|"     Cardiovascular disease (CVD) is one of the main causes of death in the United States.     Research has shown that individuals who maintain an active lifestyle are less likely to     develop CVD. This study will examine how neighborhood environments influence CVD risk factors     of residents in and around the Stapleton community of Denver, Colorado.   "
192720|NCT00361686|"     Patients undergoing second trimester abortions will recieve either patient controlled     analgesia with either remifentanyl or tramadol for pain alleviation.      We beleive both to be equally effective for pain alleviation.   "
192721|NCT00361699|"     Inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can play a role in     preventing recurrent vascular events from ischemic heart disease patients, whose mechanism     consists in not only the reduction of serum lipid level but also anti-inflammatory effects.     Serum high sensitive CRP is known to be a predictor of cardiovascular events independent of     other conventional risk factors. The present substudy examine whether such pleiotrophic     effect of HMG-CoA reductase inhibitor (statin) which decreases high sensitive CRP would be     observed in the post-ischemic stroke patients who have already been registered in the     J-STARS, and the relationship the values of high sensitive CRP and recurrence of stroke.   "
192722|NCT00361712|"     During labor there is an increased production of inflammatory mediators called cytokines.     Higher concentration of certain cytokines has been linked to adverse neonatal and maternal     outcomes.      Epidural analgesia is commonly performed after the parturient feels labor pain.      We hypothesis that preemptive epidural analgesia (initiated before labor pain begins)can     influence the production of cytokines.   "
192932|NCT00372034|"     The purpose of this study is to evaluate the role of tear volume in discomfort and dryness     sensations during contact lens wear, and the possible influence on osmolality and ocular     surface sensitivity.   "
202055|NCT00492453|"     The purpose of the study is to assess whether spinal anesthesia is or not superior to the     standard general anesthesia for fit patients undergoing laparoscopic cholecystectomy.   "
192725|NCT00361751|"     Insulin resistance and hyperglycemia contribute to negative outcomes in burned patients. We     will assess insulin sensitivity in traditional terms of glucose metabolism, and with regard     to the responsiveness of both muscle and liver protein metabolism, in severely burned     patients. Plasma free fatty acid (FFA) and tissue TG levels will be manipulated via     inhibition of peripheral lipolysis with nicotinic acid or activation of plasma lipoprotein     lipase activity with heparin, stimulation of tissue fatty acid oxidation and thus reduction     of tissue TG with the peroxisome proliferate-activated receptor (PPAR) alpha agonist     fenofibrate. Methodological approaches will include stable isotope tracer techniques to     quantify kinetic responses of protein, glucose and lipid metabolism in vivo, quantification     of intracellular stores of TG and glycogen by means of magnetic resonance spectroscopy (MRS),     as well as quantitative analysis of tissue levels of active products of fatty acids, key     intermediates of the insulin signaling pathway, glycogen, the enzyme activities of citrate     synthase and glycogen synthase and the activity of the muscle mitochondria. These studies     will clarify the physiological and clinical significance of the alterations of tissue lipid     metabolism that occur after burn injury, thereby forming the basis for new therapeutic     approaches not only in this specific clinical condition but in other clinical circumstances     in which hepatic and/or muscle TG is elevated.      We will investigate the general hypothesis that the accumulation of intracellular TG in liver     and muscle either directly causes insulin resistance in those tissues or serves as an     indictor of the intracellular accumulation of active fatty acid products, such as fatty acyl     CoA and diacylglycerol, which in turn disrupt insulin action.      The following specific hypotheses will be investigated:        1. Intracellular TG is elevated in both muscle and liver in severely burned patients. The          reduction of the fat in the liver and the insulin resistance will improve clinical          outcomes, glucose and protein metabolism.        2. The insulin signaling pathway, as reflected by phosphoinositol-3-kinase (PI3K) and PKC          activity, is impaired in tissues with elevated TG.        3. Fatty acids, or their active intracellular products, are the direct inhibitors of          insulin action, rather than the tissue TG itself.   "
192726|NCT00361777|"     This study will test the accuracy of screening tests for Cushing s syndrome in overweight     people with signs of the disorder. Cushing s syndrome is a rare disorder caused by excess     production of the hormone cortisol. Patients may have various problems, such as weight gain,     high blood pressure, diabetes, infections, mood problems, trouble concentrating, and     increased blood clotting. These symptoms are seen in many other disorders as well,     complicating the diagnosis. The reliability of tests currently used to diagnose Cushing s     syndrome is not known. To test their accuracy, subjects in this study who test positive for     Cushing s syndrome will be evaluated at NIH for 2 years to either confirm or refute the     laboratory results.      Patients between 18 and 75 years of age who are being treated at the George Washington     University Weight Management Program (GWUWMP) may participate in this study. Candidates will     be screened with a medical history, physical examination, measurement of body fat, blood     tests, and oral glucose tolerance test. They will also complete a symptoms checklist and     quality of life questionnaire.      Participants will be tested for Cushing s syndrome with a saliva collection, 24-hour urine     collection, and dexamethasone suppression test (DST). For the DST they will take 1 mg of     dexamethasone at night and report to GWUWMP the next morning for a blood draw. All specimens     blood, saliva, and urine will be tested for cortisol levels.      People whose test results are abnormal will be seen at the NIH outpatient clinic for a     medical history, physical examination, and blood tests; bedtime saliva collection; two     24-hour urine collections; and a 2-day 2-mg DST, followed by administration of     corticotropin-releasing hormone (CRH). CRH is a naturally occurring hormone that causes     cortisol levels to rise. Pre-treatment with dexamethasone prevents CRH from causing an     increase in cortisol in healthy people, but not in patients with Cushing s syndrome. For the     2-day DST, the subject takes 0.5 mg dexamethasone every 6 hours for eight doses. Two hours     after the last dose, CRH is injected through a catheter (thin plastic tube) inserted into an     arm vein. Blood is drawn just before giving CRH to measure dexamethasone and cortisol levels     and after giving CRH to measure cortisol levels.      People whose test results are normal will not be seen further at NIH. Those with high     cortisol levels will have repeat urine and saliva tests every 2 to 8 weeks for up to 24     months, and a 1-mg DST every 3 months during routine clinic visits at GWUWMP. People whose     increased cortisol is found to be due to another condition besides Cushing s syndrome will be     referred for evaluation and possible treatment. Those diagnosed with Cushing s syndrome will     have standard tests to identify the tumor causing the disorder, followed by standard medical     and surgical treatment.   "
192727|NCT00361790|"     The purpose of this clinical research study is to learn whether aripiprazole has effect on     the steady-state pharmacokinetics of escitalopram in healthy subjects. The safety and     tolerability of aripiprazole and escitalopram co-administration will also be studied.   "
192728|NCT00361803|"     A multi-center, open label, single dose Phase I pharmacokinetic (PK) characterization of     weekly IV (intravenous) topotecan given at 4mg/m2. 15 patients will be evaluated.   "
192733|NCT00368173|"     STUDY OBJECTIVE      To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of     rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with     GHIS.      STUDY DESIGN      This study is an open-label, multi-center clinical trial to evaluate the safety and     effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily     for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS)     such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional     safety and long-term efficacy data will be assessed in a second 12 month treatment period.   "
192734|NCT00368186|"     The primary objectives of this study were to assess the immunogenicity and the tolerance of     the heptavalent pneumococcal conjugate vaccine (Prevenar) in young infants (2 months of age)     with sickle cell disease when administred at 2,3, and 4 months of age.   "
192735|NCT00368199|"     The purpose of the study is to determine the sensitivity and specificity of transcranial     duplex scanning (TCD) and single photon emission computer tomography (SPECT) in patients     suspected of having Idiopathic Parkinson Disease (PD) or Atypical Parkinson Syndromes (APS)     with as golden standard the clinical diagnosis after 2-year follow-up.   "
192736|NCT00368212|"     This study will evaluate the effectiveness of an integrated three-part treatment program in     improving the quality of care and treatment outcomes of people with hypochondriasis in     primary care settings.   "
192757|NCT00369707|"     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. Giving bortezomib together with rituximab may kill more cancer cells.      This phase II trial is studying how well giving bortezomib together with rituximab works as     first-line therapy in treating patients with low-grade B-cell non-Hodgkin's lymphoma.   "
192737|NCT00368225|"     This study will explore why severe scarring of the liver (cirrhosis) develops so rapidly in     hepatitis C-infected patients who have had a liver transplant and possibly in kidney     transplant patients as well. The hepatitis C virus (HCV) can cause cirrhosis in about 20     percent of infected persons. Generally, it takes 20 years or more for cirrhosis to develop.     After liver transplantation, however, patients may develop cirrhosis in as little as 5 years.     Cirrhosis does not develop as rapidly in kidney transplant patients, but it may develop     faster than in people who do not undergo transplantation. The study will look at the possible     role of immune-suppressing medications given to liver and kidney transplant patients in     increasing the severity of hepatitis C infection and in speeding the cirrhotic process.      Patients 18 years of age and older with chronic HCV infection who require a liver transplant     for end-stage liver disease or a kidney transplant for kidney failure may be eligible for     this study. Liver transplant patients are recruited from the Inova Fairfax Liver Transplant     Center in Fairfax, Virginia, and from the Georgetown University Medical Center Liver     Transplant Institute in Washington, D.C. Kidney transplant patients are recruited from the     Transplantation Branch of the National Institute of Diabetes and Digestive and Kidney     Diseases.      Participants undergo the following procedures:        -  Regular care: As part of their regular transplant-related treatment, patients have a          medical history, physical examinations and blood draws before their transplant and on          regularly scheduled visits after the transplant.        -  Blood draws for research: Special blood tests are done to measure the immune response to          HCV. They measure the amount of HCV in the blood, the number of HCV strains present and          how they change over time and the HCV antibodies in the blood.        -  Liver biopsies: This procedure is done at 3 months, 1 year, 3 years and 5 years after          the transplant to determine the extent of scarring of the liver and to study the immune          responses within the liver, the proportion of liver cells infected with HCV and the          presence of scar-producing cells. The biopsy is done during a 1- to 2-day inpatient          hospital stay. The patients are given a sedative medication through a vein before the          procedure. The skin over the biopsy site is numbed and the biopsy needle is passed          rapidly into and out of the liver to collect a small sample of liver tissue for study.        -  Apheresis: This procedure is done to collect a large number of white blood cells needed          to test the immune response to the HCV. On the day before each liver biopsy, blood is          drawn through a needle from a vein in one arm and run through a machine that separates          and collects the white cells. The red cells and plasma are returned to the patient's          body through the same needle or a second needle in the other arm.   "
192738|NCT00368238|"     The purpose of this study is to see if a naturally-occurring hormone called erythropoietin     changes the action of platelets in the blood. Erythropoietin is made by the kidneys to     stimulate red blood cell production to prevent anemia. Platelets are small cells in the blood     that help clot blood in case of injury. Platelets also sometimes form blood clots in blood     vessels that may cause heart attacks. This study is trying to determine whether     erythropoietin increases the clotting action of platelets. Information on erythropoietin in     healthy subjects may eventually help in the treatment of patients with heart attacks.   "
192739|NCT00368251|"     The study will compare the efficacy and safety of Brivaracetam with placebo in patients with     Unverricht- Lundborg Disease (ULD).   "
192740|NCT00368264|"     Background:      Standard therapy is ill-defined for patients with systemic lupus erythematosus (SLE)     suffering from the membraneous form of Lupus nephritis (WHO class V). Therapeutic options     used at present include azathioprine.      In a small, open label safety study, patients with lupus nephritis, including patients with     membraneous lupus nephritis, have experienced a long-lasting therapeutic response, with     sustained reduction in proteinuria, following a 10 weeks course of 4 infusions of infliximab     in combination with azathioprine. This short course appeared safe with regard to SLE     activity, despite increases in autoantibody levels.      Study hypothesis:        1. The combination of four infusions of infliximab (5 mg/kg of body weight)administered at          weeks 0, 2,6, and 10, with azathioprine will be faster than azathioprine alone in          reducing proteinuria to less than 1.5 g/day in patients with active lupus nephritis WHO          class V (proteinuria > 3g/day).        2. This combination therapy will show a tolerable safety profile with regard to SLE          activity and infections.   "
192741|NCT00368277|"     Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to     ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.   "
192742|NCT00368290|"     The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces     high risk behavior in cocaine dependent subjects.   "
192743|NCT00368303|"     The study is to investigate the non-inferior efficacy of Paroxetine Controlled Release to     Paroxetine Immediate Release, as well as the drug tolerability profile when treated on     patients with Major Depression.   "
192767|NCT00369837|"     The purpose of this study was to determine the safety of clevidipine for treating severely     elevated blood pressure, defined as systolic (SBP) >180 mmHg and/or diastolic blood pressure     (DBP) >115 mmHg assessed on 2 successive occasions 15 minutes apart at baseline, in patients     with or without major organ injury, particularly with respect to controlled dose adjustment     to desired effect and prolonged continuous infusion. Enrollment of patients into the study     was to continue until the target goal of 100 patients with at least 18 hours of continuous     clevidipine treatment, including a minimum of 50 patients with acute or chronic end-organ     injury, was met.   "
192744|NCT00368316|"     Shigellosis remains a serious and frequent disease throughout the world. Development of     vaccines has been difficult because shigellae are habitants of and pathogens for humans only     and there is no consensus about the mechanism(s) of immunity to this pathogen.      Incomplete, but compelling evidence, indicates that a critical level of serum IgG anti-LPS     confers immunity to shigellosis. Important data come from our clinical trial in the Israel     Defense Forces (IDF) recruits. A randomized, double-blind, vaccine-controlled study showed     that the S. sonnei-rEPA elicited 74% protection against shigellosis occurring about 3 months     after vaccination (p=0.001). This vaccine conferred 43% (p=0.04) protection in one company     during an outbreak up to 14 days following vaccination suggesting that our Shigella     conjugates might be of value in epidemics. The efficacy of S. sonnei-rEPA was correlated with     the level of vaccine-induced IgG antibodies.      The highest incidence, morbidity, and mortality of shigellosis is in young children. But     serum antibody responsiveness to polysaccharide-based vaccines is age-dependent and infants     and young children respond poorly or not at all to both disease and vaccination. The safety     and immunogenicity of these Shigella conjugates in 4 to 6 years-old children in Israel was     demonstrated. But although the fold rise in anti-LPS was similar in the children, the level     of anti-LPS elicited by the conjugates was lower than in adults. We improved the     immunogenicity of Shigella conjugates as shown in mice and then in adult humans. Now we apply     to evaluate the safety, immunogenicity and efficacy of these improved conjugates in 1 to 4     years-old children in Israel.      In Israel, shigellosis is common especially in children. S. sonnei (Group D) comprise about     60% of the isolates followed by S. flexneri (Group B): Shigella dysenteriae type 1 (Group A)     is not found. We propose to administer 2 injections of either S. sonnei-CRM9 or S. flexneri     type 2a-rEPAsucc 6 weeks apart in a random double-blind fashion to about 6,000 1 to 4     year-olds. Active surveillance of the vaccinees for enteric infections will be maintained for     at least 2 years to evaluate the effect of vaccination.   "
192745|NCT00368329|"     To study the safety and feasibility of stereotactic radiation dose escalation following     neoadjuvant chemotherapy with concurrent conventionally fractionated radiation, by evaluating     the acute and late toxicity of treatment.   "
192746|NCT00368342|"     Chronic Bronchiolitis or Resistant Asthma? Testing a way to diagnosis and treatment   "
192774|NCT00369928|"     This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group,     multicenter study to evaluate the safety, efficacy, and PK of oral administration of     PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of     PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening     visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and     anti-cytokine therapies except MTX. After the washout period, patients determined to be     eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or     placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after     the last treatment visit. The primary efficacy endpoint will be the proportion of patients     meeting the ACR 20 response criteria after 12 weeks of treatment.   "
192775|NCT00369941|"     This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in     combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected     patients not previously treated.   "
192748|NCT00368368|"     This study will investigate the effect of renal impairment on the     pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and     will evaluate the effect of renal function on the safety of the drug. Patients will be     assigned to treatment groups according to their renal function (normal, moderate renal     impairment, or severe renal impairment). After a 1 week washout period from current oral     anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator     (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on     study treatment is <3 months, and the target sample size is <100 individuals.   "
192749|NCT00368381|"     The purpose of this study is to determine if the combination of hydrocortisone plus     fludrocortisone is more efficacious than hydrocortisone alone in treating adrenal     insufficiency in severe sepsis.   "
192750|NCT00368394|"     To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after     single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic     clamp technique using the Biostator (TM).   "
192751|NCT00368407|"     To determine the optimal treatment frequency of 308-nm excimer laser for vitiligo and     identify the key clinical variable(s) associated with the treatment efficiency under the     optimal treatment frequency.      Prospective, randomized, comparative study among groups of vitiligo patients treated with     308-nm excimer laser, with the limitation of no follow-up.   "
192752|NCT00368420|"     The purpose of this study is to validate a score developed by the AGO-OVAR for complete     resection of the tumor   "
192753|NCT00368433|"     This study will investigate how the sensitivity to touch and smell in patients with Tourette     syndrome (TS) may differ from that of people without TS. TS is a neurological disorder that     causes people to have uncontrolled movements called tics. A tic can also be vocal, like a     cough or bark or string of bad words. The tic is preceded by a premonitory urge that may     feel like an itch or pressure that builds until the tic occurs. To some patients, the tic     feels like a response to an involuntary sensation. In patients with TS, sensory information     may be processed differently than it is in people without TS. This study will compare how     strong a sensation feels in TS patients and healthy volunteers. It will also look for muscle     activity that may be responsible for the feelings in the area of the tic.      Healthy normal volunteers and people with Tourette syndrome, 18 to 65 years of age, may be     eligible for this study. Candidates are screened with a medical history and brief physical     and neurological examinations. TS patients complete a questionnaire about their tics and are     interviewed by a psychiatrist. Women who can become pregnant will have a urine pregnancy test     prior to any other procedures. Pregnant women cannot participate.      All participants undergo sensory testing for touch and smell. They are asked to distinguish     between a scented and scentless object and rate how strongly they feel the scent. Later, with     their eyes closed, they are asked to tell whether or not they are being touched, and to rate     how intensely they felt the touch.      In addition to the sensory testing, TS patients, but not normal volunteers, undergo     electromyography (EMG), a test that measures the electrical activity of muscles. For surface     EMG, small metal disks called electrodes are filled with a conductive gel and taped to the     skin. Wire EMG involves inserting a wire into a muscle using a needle. All patients have     surface EMG and those who consent to it will also have wire EMG.   "
192768|NCT00369850|"     RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help     measure bone loss in women receiving treatment for breast cancer. The test results may help     doctors plan better treatment.      PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women     with breast cancer receiving treatment in clinical trial IBCSG-1-98.   "
192769|NCT00369863|"     To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory     diabetic macular edema.   "
192770|NCT00369876|"     Anorexia in children with burn injury is a common phenomenon. The study is searching for the     origin of the anorexia in those children. The study correlates between the level peptides of     the immune and the endocrine systems and the length of the anorexia.   "
192771|NCT00369889|"     The purpose of this study is to determine the rate of response with the combination of     erlotinib and bevacizumab in previously treated patients with thymoma or thymic carcinoma,     and to determine potential molecular markers that may predict response to therapy in patients     with thymoma or thymic carcinoma.   "
192754|NCT00368446|"     Healthy volunteers and patients with diseases that involve problems clearing mucus from the     lungs will be examined and tested to better understand the reasons for recurring lung     infections in these patients and to try to develop better ways to diagnose and treat them.     The study will also try to identify the genes responsible for these diseases.      Healthy volunteers 18 years of age and older and patients 2 years of age or older with     suspected primary ciliary dyskinesia (PCD), variant cystic fibrosis (CF) or     pseudohypoaldosteronism (PHA) may be eligible for this study. Patients enrolled in the     Natural History Study of Nontuberculous Mycobacteria at NIH or other NIH natural history     protocols may also be enrolled. Participants undergo the following tests and procedures     during a 1-day visit at the NIH Clinical Center, as follows:      All patients and normal volunteers have the following procedures:        -  Physical examination and review of medical and genetic history and family genetic          history.        -  Lung function test and measurement of oxygen saturation level.        -  Nitric oxide measurement to measure the amount of nitric oxide production in the nose: A          small tube is placed in the nose while the subject breathes through the mouth into a          cardboard tube.      All patients have the following additional procedures:        -  Blood tests for liver and kidney function, blood count, immunoglobulins and pregnancy          test (where appropriate).        -  Blood test or buccal scrape (brushing the inside of the cheek) to obtain DNA to look for          gene mutations that cause PCD, CF or PHA.        -  Scrape biopsy of cell lining the inside of the nose: A small toothpick-sized plastic          stick with a tiny cup on the end is used to get nasal lining cells to look at the cilia          (hair-like structures that move mucus).        -  Semen analysis (in some men) to test sperm tail function or structure.      Patients suspected of having a variant of CF or PHA, including nontuberculous mycobacterial     lung disease, have the following additional procedures:        -  Sweat chloride test: A medicine is placed on the arm to produce sweat; then, a very low          level of electric current is applied for 5 to 12 minutes. Sweat is collected in a          plastic tube and tested for salt content.        -  Blood draw for CF genetic testing, if necessary, and to measure levels of the enzyme          trypsin.        -  Saliva collection to measure sodium and chloride content.        -  Nasal potential difference to measure the electrical activity of the cells lining the          inside of the nose: A soft plastic tube filled with a salt solution is passed into the          nasal passage and a sterile needle is placed under the skin of the arm. This test          provides information about how the lining of the nose is able to get used to changes in          temperature and humidity. (Normal volunteers also have this test.)   "
192755|NCT00369681|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving rituximab together with combination chemotherapy may kill more     cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with combination     chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV     Hodgkin's lymphoma.   "
192756|NCT00369694|"     The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as     72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been     controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to     moderate risk variceal bleed patients and hence can save cost and may decrease length of     hospital stay especially in the I.C.U or high dependency units.   "
192758|NCT00369720|"     We propose a preliminary trial to evaluate the safety and efficacy of using more restricted     oxygen during resuscitation for VLBW infants than is utilized currently in an effort to     reduce the oxidant stress of such treatment, and to possibly reduce associated multi-system     organ related dysfunction.      In attempting to design a trial comparing higher versus lower oxygen during neonatal     resuscitation with the potential for benefit to the enrolled infants, and a minimal level of     risk, and acknowledging that the use of Room Air may be considered premature in view of the     lack of any safety data in this population, we are proposing to utilize an oxygen blender and     a pulse oximeter in the delivery room in the treated group. The treated group will have their     fraction of inspired oxygen increased from 21%, as necessary, to achieve a target oxygen     saturation of 85 to 90% at 5 minutes of life, compared with the standard of care group who     will receive 100% oxygen without the use of a blender, which is the current approach in most     centers in this country. The targeted saturation of 85% will provide enough oxygen to treat     any ventilation/perfusion mismatch, while exposing the infants to significantly less inspired     oxygen.      Hypothesis: We hypothesize that the use of restricted inspired oxygen during resuscitation     will result in a significant reduction in oxidant stress without any harmful clinical     effects.   "
192759|NCT00369733|"     To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant     human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.   "
192760|NCT00369746|"     The purpose of this study is to determine if having an alcohol use disorder affects recovery     from depression, and also whether recovery from depression in patients who have alcohol use     disorders is also accompanied by improvement in the alcohol use disorder.   "
192761|NCT00369759|"     The primary objective of this study is to describe the incidence of RSV-associated LRI among     infants <1 year of age presenting to the ED during selected shoulder months.   "
192762|NCT00369772|"     To assess the effect of Aranesp on the hemoglobin of CRI subjects who are recombinant human     erythropoetin (rHuEPO)-naïve or converting from rHuEPO therapy   "
192763|NCT00369785|"     RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of     life in patients who have undergone radiation therapy for brain tumors. It is not yet known     whether donepezil is more effective than a placebo in lessening side effects of radiation     therapy in patients with brain tumors.      PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in     lessening side effects of radiation therapy compared with a placebo in patients who have     undergone radiation therapy for brain tumors.   "
192764|NCT00369798|"     The primary purpose of this protocol is to compare PDE4 levels before and after starting a     selective serotonin reuptake inhibitor (SSRI) sertraline, citalopram or escitalopram in     unmedicated depressed patients. The secondary purpose is to compare PDE4 levels between     unmedicated depressed patients and healthy subjects.   "
192765|NCT00369811|"     To evaluate the analgesic efficacy of oxycodone and fentanyl in the treatment of     postoperative pain after laparoscopic cholecystectomy.   "
192766|NCT00369824|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and     thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical     cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents     platform. Therefore, this Phase 3b study is designed to evaluate the safety and     immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine     (580299) as compared to the administration of any of the vaccines alone.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
192772|NCT00369902|"     The Purpose of this study is to evaluate whether cognitive and emotional components take part     in the positive acupuncture effect on pain.   "
192776|NCT00369954|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) and giving them in different     ways may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine     together with carboplatin works in treating patients with persistent or recurrent ovarian     epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that responded to     previous cisplatin or carboplatin.   "
192777|NCT00369967|"     We hypothesize that using quick start initiation of the contraceptive vaginal ring in     adolescents seeking birth control will improve compliance compared to traditional start. We     will conduct a randomized controlled trial comparing quick start to traditional start     initiation of the contraceptive vaginal ring in adolescents seeking birth control. The     primary study outcome is method continuation at 3, 6, and 12 months. Secondary outcomes     include abnormal bleeding, product satisfaction, and adverse events.   "
192778|NCT00369980|"     L-[3-18F]-α–methyltyrosine (FMT) is amino-acid tracer for positron emission tomography (PET),     and is used for tumor detection because malignant tumor cells accumulate 18F-FMT based on the     increased expression of amino-acid transporter. This study was conducted to investigate a     usefulness of 18F-FMT PET in combination with 18F-FDG PET for the diagnosis of sarcoidosis in     patients with suspected malignancy.   "
192779|NCT00369993|"     Spacers are used by people with respiratory diseases who have problems using MDIs (metered     dose inhalers). This study used fluticasone propionate/salmeterol to look at the     pharmacokinetic profiles produced by different spacers in their washed and un-washed states.   "
192780|NCT00370006|"     Objectives of this trial are to:        1. Evaluate the kinetics and magnitude of the CMV-specific immune response post-Towne          challenge (3000 pfu) in healthy CMV-seronegative volunteers who received VCL CT02          administered ID or IM 9 to 15 months previously as measured by: 1) ELISA and/or          virus-neutralizing antibody titers for gB; 2) T-cell IFN-g ELISPOT; 3) T-cell          proliferation assays (CFSE) for IE1, pp65, and/or gB; and possibly 4) cytokine and          phenotypic flow cytometry responses to pp65, IE1, and/or gB.        2. Evaluate the safety safety of Towne challenge in healthy CMV-seronegative adult subjects          who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02)          administered intramuscularly (IM) or intradermally (ID).      Our hypothesis is that the immune response to Towne vaccine 3000 pfu challenge after VLC-CT02     priming will be greater than that after Towne vaccination alone (concurrent controls will be     administered Towne alone in a concurrent, companion trial).   "
192781|NCT00370019|"     This study will determine whether giving estrogen replacement therapy through an estradiol     patch can improve ovulation rates in women with spontaneous premature ovarian failure. The     ovaries are glands in women that produce female hormones and normally release an egg once a     month. In women with spontaneous premature ovarian failure, the ovaries stop working too     soon. Women with this disorder have abnormally high levels of leuteinizing hormone (LH) in     their blood, which impedes normal ovulation. In some women, estrogen replacement can suppress     LH levels to the normal range.      Women between 18 and 40 years of age with premature ovarian failure may be eligible for this     4-month study. Participants receive either standard hormone replacement therapy, consisting     of an estradiol patch and progestin tablets, or placebo. The placebo group receives patches     and tablets that look the same as those for the group with active treatment but they contain     no hormone. All participants wear the patch every day and take the tablets the first 12 days     of each month. In addition to taking the study drug, participants have blood drawn once a     week for the 16 weeks of the study.      At the end of the trial, women who were in the placebo group are offered the opportunity to     receive the estrogen patch and progestin therapy for another 16 weeks and continue the blood     tests to determine if they ovulate on this treatment.   "
192782|NCT00370032|"     This study will look at colonic mucosal blood flow in subjects who have taken alosetron vs     placebo and healthy volunteers vs diarrhea-predominant Irritable Bowel Syndrome (d-IBS)     patients.   "
192783|NCT00370045|"     The purpose of this study is to compare levels of clot formation (platelet aggregation),     markers of heart muscle damage, and inflammation in two groups undergoing percutaneous     coronary stent implantation. The first group will be on a regimen of high-dose clopidogrel     used in combination with bivalirudin plus eptifibatide, and the second group will be on a     regimen of high-dose clopidogrel with bivalirudin alone. Clinical outcomes will be determined     up to one year after enrollment.   "
192784|NCT00370058|"     Elevated homocysteine levels are associated with depression and cognitive impairment. When     depression ameliorates due to treatment, homocysteine serum levels often normalize. Aim of     the present study is to investigate, whether repeated ECT treatment leads to changes in     homocysteine levels and if these changes are associated with the occurrence of cognitive     impairment after ECS.      10 patients suffering from therapy-resistant depression shall be enrolled. Patients are     treated with repeated ECT (three times the week). Before, directly after and one day after     ECT treatment, blood samples are drawn and patients receive cognitive testing. Depressive     symptomatology is checked with different rating scales.   "
192785|NCT00370071|"     The purpose of this study is to determine if the study drug is effective and safe in the     treatment of Multiple Sclerosis (MS) in patients of Chinese origin.   "
192786|NCT00370084|"     Itopride is a new compound that is already marketed in Japan and in some countries of Eastern     Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis.     Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea     and vomiting following ingestion of a meal. The goal of this study is to evaluate the effects     of Itopride on gastric motor function and glycemia in patients with diabetes.   "
192787|NCT00370097|"     The purpose of this study is to address an Food Drug and Administration (FDA) request to     provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following     administration of fluticasone propionate HFA.   "
192803|NCT00370318|"     The purpose of this trial is to assess if the rate of febrile reactions following the     co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered     when paracetamol is given prophylactically.   "
192833|NCT00370708|"     In this study we are trying to compare the safety and financial benefit of starting the     realimentation early versus conventional oral intake following the Cesarean surgery in Iran.   "
192788|NCT00370110|"     Itopride is a new compound that is already marketed in Japan and in some countries of Eastern     Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis.     Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea     and vomiting following ingestion of a meal. This is a randomized, parallel group, two dose     double blind, placebo-controlled study evaluating the effects of itopride (100 mg and 200 mg     three times daily) and placebo on gastric motor and sensory functions in healthy volunteers.   "
192831|NCT00370682|"     This descriptive study will evaluate the safety and immunogenicity of different formulations     of the WRAIR dengue vaccine compared to a placebo.   "
192832|NCT00370695|"     The purpose of this study is to evaluate the efficacy of spinal cord stimulation (SCS) using     the Precision implantable neurostimulation device for chronic and intractable back pain in     subjects who are not candidates for surgery or who have chosen to seek alternative therapy.   "
192789|NCT00370123|"     Endometriosis is a chronic disabling inflammatory disease which effects 15-20% of women in     their reproductive life.      In patients suffering from endometriosis retrograded menstrual cells induce an inflammatory     response.Endometriosis has also been considered to be an autoimmune disease, owing to the     presence of auto antibodies, the association with other autoimmune diseases and recurrent     immune-mediated abortion.      We aim to study this aberrant regulation of endometrial cell apoptosis by investigating the     peripheral blood immune system of patients suffering from endometriosis.      Hypothesis:      We hypothesized that immune peripheral mononuclear cells of patients suffering from pelvic     endometriosis react differently to eutopic endometrial cells than matched control women     group. This difference could be study on a molecular, antigenic and/or apoptotic cycle gene     expression. We also hypothesized that a deficiency of regulatory T cells is associated with     the progression of endometriosis.   "
192790|NCT00370136|"     The purpose is to evaluate,in 20 patients, if the sentinel node(s) in melanoma can be     detected by lymph contrast ultrasound. In comparing the patients will also get     lymph-scintigraphy and sentinel node detection wiht blue dye.      The goal is to improve the method for detecting sentinel node(s) in melanoma.   "
192791|NCT00370149|"     The primary purpose of the study is to determine if a therapeutic difference exists between     central venous catheters impregnated with minocycline and rifampin and conventional catheters     not impregnated with antibiotics when used in children at high risk for bloodstream     infections (CABSI) after cardiac surgery.   "
192792|NCT00370162|"     The purpose of this study is to demonstrate the safety of the gynaecological formulation in     normal and usual usage condition.   "
192793|NCT00370188|"     The quest for an effective medication therapy for problem gambling remains an important     priority for the problem gambling treatment research field. While several medications have     been evaluated in controlled clinical trials, no medication has been shown to unequivocally     reduce gambling behaviour and, to date, no medication has been approved for treating this     disorder. Recently, topiramate, indicated for the treatment of seizure disorders, has shown     some promise as a medication therapy for problem gambling. In this project, the efficacy of     topiramate will be evaluated in a placebo-controlled clinical trial, the first study to do     so. The interaction of the effects of the medication and gambling sub-type will be examined     to determine whether the efficacy of topiramate is correlated with the specific     biopsychosocial history of the gambler.   "
192794|NCT00370201|"     This clinical trial will test the efficacy and safety of oral colchicine in prevention of     proliferative vitreoretinopathy (PVR) in cases of rhegmatogenous retinal detachment   "
192795|NCT00370214|"     The REVEAL Registry™ is a multicenter, observational, U.S.-based study of the clinical course     and disease management of pulmonary arterial hypertension (PAH) patients. All consecutive     consenting patients diagnosed with WHO Group I PAH according to specific hemodynamic criteria     at participating institutions will be enrolled. Participating patients will be followed for a     minimum of five years from the time of enrollment.   "
192796|NCT00370227|"     This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of     the pneumococcal conjugate vaccine, co-admin with a 1st dose or a 2nd dose of MMRV vaccine at     12-14 or respectively 14-16 months of age in children primed with the pneumococcal conjugate     vaccine in study 105553. Antibody persistence will be evaluated at 8-10 months after     completion of the 3-dose immunization course in study 105553. The immunogenicity, safety and     reactogenicity of the 1st and 2nd dose of MMRV vaccine will also be evaluated when co-admin     with the pneumococcal conjugate vaccine between 12-16 months of age.      The study has 3 groups.        -  The 1st group will receive the booster dose of pneumococcal conjugate vaccine + 1st dose          of MMRV vaccine at 12-14 mo of age and the booster dose of Infanrix hexa™+ 2nd dose of          MMRV vaccine at 14-16 mo of age.        -  The 2nd group will receive the booster dose of Infanrix hexa™ + 1st dose of MMRV vaccine          at 12-14 mo of age and the booster dose of pneumococcal conjugate vaccine + 2nd dose of          MMRV vaccine at 14-16 mo of age.        -  The 3rd group will receive the booster dose of pneumococcal conjugate vaccine + the          booster dose of Infanrix hexa™ at 12-14 mo. Subjects will be offered one dose of          Priorix™ and Varilrix™ at 14-16 mo of age, outside the study.   "
192797|NCT00370240|"     The aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of     ropivacaine) to prevent chronic pain after breast surgery for cancer.   "
192798|NCT00370253|"     The purpose of this study is to determine whether noradrenalin is as effective and safe as     terlipressin in the treatment of hepatorenal syndrome   "
192799|NCT00370266|"     The purpose of this study is to determine whether intraocular injection of triamcinolone is     effective in the treatment of macular edema in acute branch retinal vein occlusion.   "
192800|NCT00370279|"     To compare the visual and anatomical outcomes and complications of four surgical techniques     (1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy     with encircling band, 4- triamcinolone assisted vitrectomy) for management of pseudophakic     and aphakic retinal detachment   "
192801|NCT00370292|"     Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed     monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some     biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to     monitor the blood values of these biomolecules at different time intervals, to optimize the     synergism between pemetrexed and gemcitabine.   "
192804|NCT00370331|"     The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of     eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting     dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety     and pharmacokinetics in a dose-finding Study (TRA100773). This Phase III study is a     randomized, double-blind, placebo-controlled, Phase III study, to evaluate efficacy, safety     and tolerability of eltrombopag, initially administered as 50 mg oral tablets once daily for     six months in adult subjects with previously treated chronic ITP. Subjects will be randomized     2:1, eltrombopag to placebo, and will be stratified based upon splenectomy status, use of ITP     medication at baseline and baseline platelet count less than or equal to 15,000/µL. Subjects     will receive study medication for 6 months, during which the dose of study medication may be     adjusted based upon individual platelet counts. In addition, subjects may taper off     concomitant ITP medications and may receive any rescue treatments as dictated by local     standard of care. After discontinuation of study medication, subjects will complete follow-up     visits at weeks 1, 2, 4 and months 3 and 6.   "
192805|NCT00370344|"     The trial compares minilaparotomy (small-incision) cholecystectomy with (key-hole)     laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two     groups of surgeons, each group being trained for one of the two methods.   "
192806|NCT00370357|"     The purpose of this study is to determine if SPL7013 Gel (VivaGel™) is safe when applied     topically once a day for seven consecutive days to the shaft and glans of the penis in     healthy male volunteers. The study will compare the safety of SPL7013 Gel on the penile     epithelium and urethral mucosa to the safety of a placebo gel. The study will also assess the     systemic safety of SPL7013 Gel, systemic absorption of the active ingredient of SPL7013 Gel,     and the acceptability of the study products to the male volunteers.   "
192807|NCT00370370|"     To compare the efficacy and safety results of intravitreal bevacizumab alone with bevacizumab     + triamcinolone acetonide in neovascular AMD.   "
192808|NCT00370383|"     Patients ≥ 70 years of age with locally advanced unresectable or metastatic non-small cell     lung cancer (NSCLC) frequently do not receive systemic cytotoxic chemotherapy due to concerns     regarding their inability to tolerate treatment. Epidermal growth factor receptor (EGFR)     tyrosine kinase inhibitors (TKIs) are agents with favorable toxicity profiles that have shown     activity in patients with NSCLC. Erlotinib as a single-agent is currently approved for the     treatment of patients with NSCLC whose disease has progressed following one prior course of     chemotherapy and is currently being evaluated in NSCLC patients who have not received prior     systemic treatment. However, when studied with combination chemotherapy in the first-line     setting, continuous daily administration of erlotinib did not result in improved patient     survival. Further clinical and in vitro data suggest that the sequencing of cytotoxic     chemotherapy with EGFR TKIs is important to maximize their therapeutic potential when     administered in combination.      Satraplatin is an oral, investigational anticancer drug that is a member of the     platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven     to be one of the most effective classes of anticancer therapies. Unlike the currently     marketed platinum-based drugs, satraplatin can be given orally and is currently being     evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone     refractory prostate cancer.      The rationale for this study is to develop an active and well-tolerated oral regimen for     patients ≥ 70 years of age with NSCLC. Administration of the study drugs will be sequenced     with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle.     The primary endpoint will be progression-free survival (PFS). Patients will be randomized to     treatment with either the experimental regimen or single-agent continuous erlotinib.   "
192809|NCT00370396|"     This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of     GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of     age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553.     Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization     course in study 105553. The immune response to a booster dose of GSK Biologicals'     pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not     primed with GSK Biologicals' vaccine but with Prevenar™.      The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal     conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children     primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of     children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal     conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib     vaccine.   "
192810|NCT00370409|"     Late vitreous hemorrhage in postvitrectomized diabetic eyes may be due to fibrovascular tuft     formation in sclerotomy sites. Cryotherapy of sclerotomy sites may prevent bleeding by     regressing the fibrovascular tuft. This study will detect the safety and efficacy of     cryotherapy of sclerotomy sites for prevention of late vitreous hemorrhage in vitrectomized     diabetic eyes.   "
192811|NCT00370422|"     The purpose of this study is to compare the efficacy and safety of intravitreal injection of     bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory     diabetic macular edema.   "
192812|NCT00370435|"     This is a study of GW274150, an iNOS (inducible nitric oxide synthase) inhibitor to     investigate safety, tolerability and pharmacokinetics (PK) in the rheumatoid arthritis (RA)     population (greater than 50 years). Safety, tolerability and PK of GW274150 in an adult and     elderly population have not yet been determined. Therefore this study is designed to ensure     that 90mg GW274150 will be safe and well-tolerated in this adult and elderly RA patient     population on methotrexate. The assessments will include pharmacokinetics (PK), liver     function tests and creatinine clearance.      This study will provide confidence that a single 90mg dose of GW274150 results in exposure in     RA subjects similar to that expected from healthy volunteers and asthmatics.   "
192813|NCT00370448|"     The purpose of this study is to determine whether school-based social support systems are     effective in preventing suicide in medical students.   "
192835|NCT00370734|"     In active phase of thyroid eye disease some patients have obvious upper lid retraction , and     sometimes exposure keratopathy .To date there is not any standard treatment for this     situation . We are going to compare the natural course of the upper lid retraction with     injection of botulinum toxin A injection to upper lid percutaneously.   "
192836|NCT00370747|"     The purpose of this study is to determine whether ecabet ophthalmic solution is an effective     treatment for dry eye syndrome   "
192837|NCT00370760|"     To evaluate the efficacy of oral colchicine combined with intraoperative infusion of     dexamethasone, low molecular weight heparin and 5-FU during vitrectomy for management of     established proliferative vitreoretinopathy (PVR)   "
192838|NCT00370773|"     This study will systematically evaluate the programming parameters of the Precision Spinal     Cord Stimulation Device to optimally relieve pain while minimizing any uncomfortable side     effects.   "
192814|NCT00370461|"     In Ontario, most people who experience a cardiac arrest at home (when their heart stops     beating) only receive basic life support from Primary Care Paramedics (PCPs) and all are     transported to the hospital. Most are pronounced dead by the emergency physician as the mean     survival rate for these patients is 5%. Allowing Primary Care Paramedics to use a termination     of resuscitation guideline would identify futile cases for which further resuscitation is     unwarranted and decrease the number of patients being transported to the emergency department     (ED) for pronouncement.      There are numerous advantages to this strategy; first, it may improve the efficiency of the     ED because cardiac arrest patients require immediate attention that is diverted from patients     who have a better chance at survival. Second, the risk of injury and the monetary costs for     the paramedic and the public would be minimized with fewer light and sirens transports     which are known to be hazardous to motorists, pedestrians, and Emergency Medical Services     (EMS) personnel.      For each cardiac arrest, PCPs will respond to the call as usual and implement standard basic     life support cardiac arrest protocols. Patients are then categorized according to the     termination of resuscitation recommendations:        1. no return of spontaneous circulation is achieved (no heartbeat);        2. no shock was given prior to transport; and        3. the arrest (when the heart stops beating) was not witnessed by EMS personnel.      If all of these criteria are true, the PCP will contact the hospital and the decision by the     emergency physician will then be made to stop life saving measures (terminate resuscitation)     in the home or continue with life support and transport the patient to the local emergency     department.      This study aims to document the usefulness of the termination of the resuscitation guideline     in decreasing the rate of transport of out-of-hospital cardiac arrest patients to the ED.     Secondary aims of this implementation study will be to describe the rates of erroneous     application of the guideline. The comfort of use of the rule among paramedics and base     hospital emergency physicians will be described.   "
192815|NCT00370474|"     Magnetic navigation will permit delivery of the LV lead tip to a prospectively defined     location more efficiently and in a higher proportion of patients than is possible with manual     navigation.   "
192816|NCT00370487|"     There have been no studies in developing countries assessing the safety of midlevel providers     (MLP) compared to physicians in performing first-trimester manual vacuum aspiration abortion.     In South Africa and Viet Nam, MLP (midwives and physician assistants) are trained and     accredited to perform first trimester abortions to increase women’s access to safe abortion     services. To assess the safety of abortions performed by midlevel provider compared to     physicians, complication rates of first-trimester manual vacuum aspiration are compared     between types of providers in the two countries. We test the null hypothesis that the two     types of providers provide abortions equally safely.   "
192817|NCT00370500|"     BACKGROUND:      Epigenetic modifications such as DNA-methylation and histone acetylation are known to be     involved in the pathophysiology of schizophrenia. Aim of the present study is to investigate        1. whether differences in the methylation pattern of the promoters of dopaminergic genes          exist between schizophrenic patients and healthy controls and        2. whether treatment with the second generation antipsychotic quetiapine leads to changes          in the methylation pattern of those genes in patients suffering from schizophrenia.      STUDY DESIGN AND METHODS:      50 male patients and 50 male controls are to be enrolled into the study. Patients will be     treated with quetiapine for 3 weeks. Blood samples will be drawn before treatment and after     three weeks to measure DNA-methylation status. Clinical characterisation includes PANSS,     AIMS, BDI. Healthy probands will not be treated.   "
192818|NCT00370513|"     Liver cancer is a good target for anti-angiogenic treatments such as pazopanib. The effect of     pazopanib in patients with liver cancer are unknown. This study is designed to evaluate the     safety, tolerability and best dose of pazopanib to be given to patient with liver cancer.   "
192819|NCT00370526|"     The literature shows that approximately 40% of individuals who receive a cardiac     resynchronization therapy (CRT) device for symptomatic congestive heart failure (CHF) do not     have a clinical benefit from the device. The HEAL-HF protocol will compare the outcomes of     conventionally placed CRT devices with magnetically placed CRT devices by assessing     hemodynamic parameters during the magnetic placement of the left ventricular (LV) lead.   "
192820|NCT00370539|"     To compare the efficacy and safety of photodynamic therapy (PDT) combined with intravitreal     bevacizumab versus combination of photodynamic therapy , intravitreal bevacizumab and     intravitreal triamcinolone for neovascular AMD.   "
192821|NCT00370552|"     The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is     effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy     in participants with metastatic breast cancer. The study will also assess the safety of this     combination treatment.   "
192822|NCT00370565|"     To assess the impact on glucose control by inhaled insulin alone or added to two oral     anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral     anti-diabetic agents.   "
192823|NCT00370578|"     Early promising data are published focusing on the role of manual thrombus aspiration devices     in patients with ST segment elevation (STEMI).      The aim of our single center randomized study is to evaluate the early and late effect of     thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of STEMI     population.      Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may     give early and late advantages compared to the standard primary PCI technique.   "
192824|NCT00370591|"     Comparison of two asthma treatments by lung function measures.   "
192825|NCT00370604|"     The purpose of this study is to determine the effect of 19g versus =>18g traditional     Tuohy-type epidural needles on the incidence and severity of postdural puncture headache     (PDPH).   "
192826|NCT00370617|"     Chronic hepatitis C virus (HCV) infection is associated with an increased risk for the     development of type 2 diabetes and HCV infection itself may promote insulin resistance,     irrespective of the severity of liver disease.      Insulin resistance seems to be genotype specific and may play a role in fibrogenesis in     chronic hepatitis C.      In an “in vitro” model, increased levels of insulin may promote increased HCV replication.      RATIONALE Decreased insulin resistance and reduced hyperinsulinemia may facilitate the     efficacy of anti-viral drugs on HCV replication.   "
192827|NCT00370630|"     In this study we intend to evaluate and compare the outcomes of intravitreal avastin versus     avastin and triamcinolone on improving the visual acuity and macular edema and late     complications of CRVO like NVI and NVG.   "
192828|NCT00370643|"     The purpose of the study is to seek if there is difference to state glucose level in     80-120mg/dl or 200mg/dl in patients submitted to open heart surgery   "
192829|NCT00370656|"     The purpose of this study is to assess the effectiveness of pregabalin, duloxetine and     amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by     Brief Pain Inventory (BPI).   "
192830|NCT00370669|"     to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone     acetonide with laser photocoagulation on clinically significant macular edema (CSME)   "
192840|NCT00370799|"     To demonstrate clinically significant improvements or lack thereof in the caudal epidural     patients with our without steroids.      To evaluate differences in outcomes in patients receiving steroids compared to those patients     randomized to the local anesthetic group who did not receive steroids.      To assess improvements among patients and compare steroid groups with each other and local     anesthetic group.      To evaluate and compare the adverse event profile in all patients   "
192841|NCT00370812|"     This is a randomized clinical trial study to identify the role of AMT (amniotic membrane     transplantation) in treating epithelial defect, symblepharon prevention preventing corneal     vascularization and opacity decreasing pain and improving visual acuity, and patients with     acute chemical burns.   "
192842|NCT00370825|"     The investigators are using a sequential design to combine miltefosine and AmBisome in     different doses.   "
192843|NCT00370838|"     The goal of this study is to confirm that levetiracetam has a better tic-suppressing profile     than that of the widely used tic-suppressing medication, clonidine. More specifically, the     investigators hypothesize that in a 15 week placebo run-in, double-blind, medication     cross-over trial; levetiracetam will be more effective and have fewer side-effects than     clonidine.   "
192844|NCT00370851|"     In this study we intend to evaluate the outcome of intravitreal avastin on improving the     visual acuity and macular edema and late complications of BRVO like NVD and NVE   "
192845|NCT00370864|"     The World Health Organisation has warned that an influenza pandemic is inevitable. The avian     influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic.     Children are likely to be a special target group for vaccination; therefore, this study will     test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.   "
192846|NCT00370877|"     The aim of this clinical research project is to evaluate the use of the recombinant human     activated factor VII (rhFVIIa), given as a salvage therapy, in women with a dramatic     postpartum hemorrhage still ongoing after all the currently available medical and surgical     treatments. We are going to compare its early use, before elective surgery or arterial     embolization, to its late use, after embolization or surgery, before salvage hysterectomy.   "
192847|NCT00370890|"     The purpose of this trial is to study the benefit of adjuvant chemotherapy using gemcitabine     and cisplatin in high risk NPC patients with residual EBV DNA following primary radiotherapy     with or without concurrent cisplatin.   "
192848|NCT00370903|"     The purpose of this retrospective study is to determine if there is an increase in postpartum     depression (PPD) among women who undergo an emergency cesarean section as opposed to a     planned cesarean section. We will analyze the hospital and clinic medical records of     postpartum women who delivered by cesarean section (CS) at Tulsa Regional Medical Center     between January 1, 2003, and June 1, 2005, and who obtained their postpartum care at the OSU     Ob/Gyn Clinic in Tulsa, Oklahoma. We will record whether the cesarean was planned or     emergent, and we will note the score they received on the Edinburgh Postnatal Depression     Scale when they came to the clinic for their four-week postpartum visit. A score of 12 or     lower on the EPDS will be considered not depressed, and a score of 13 or higher will be     considered depressed. Numbers of depressed patients will be compared among the two types of     cesarean sections and analyzed for statistical differences using the chi-squared method of     analysis.   "
192849|NCT00370916|"     Patient transfer between sites of care is regular practice during an episode of care in our     current health care system. Yet inter-site transfer is associated with lapses in care quality     that adversely affect patient outcomes. A common iatrogenic harm precipitated at the time of     transfer is harm from drug prescribing, or adverse drug events (ADEs). In this study we will     evaluate a medication reconciliation tool developed to help providers make effective     prescribing decisions at the time of transfer between VA sites of care (Improved Prescribing     after Transfer (IPT)). We will evaluate the quantitative effectiveness of the tool in     reducing transition drug risk and ADEs. We additionally will conduct focus group discussions     and cognitive task analysis among end-users to better understand how providers make     drug-prescribing decisions at the time of transfer and to assess factors influencing     effective use of the tool.   "
192850|NCT00370929|"     Epileptic seizures may occur at times of stress and commonly increase life stress. This study     will evaluate whether meditation improves seizure control and quality of life for individuals     with uncontrolled epilepsy.   "
192851|NCT00370942|"     This study was designed to find dose response and as extension in treatment of GW823093C.   "
192852|NCT00370955|"     The purpose of this study is to compare two surgical techniques (high vacuum and low vacuum)     on corneal endothelium after phacoemulsification.   "
192853|NCT00370968|"     Three-hundred-and-fifty-two males aged 1-36 months with acute non-dysenteric diarrhoea and no     systemic illness will be enrolled in this clinical trial. Eligible children will be     stratified by their age (1up to 5 months, 6-35 months). Within the two age strata the     patients will be randomized to receive zinc-ORS (fortified with 40 mg elemental zinc as zinc     gluconate per litre) or standard WHO ORS. The major outcome measures will be stool output and     duration of diarrhea. The safety of administering zinc will be determined by examining the     effect of zinc ingestion on vomiting, sodium and potassium homeostasis, plasma zinc and     copper, and iron stores and concentration of serum transferrin receptor.   "
192854|NCT00370981|"     The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.   "
192855|NCT00370994|"     Clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic     neurolysis compared to those patients randomized to the control group who did not receive     adhesiolysis and hypertonic saline neurolysis. Improvement will be assessed in relation to     the clinical outcome measures of pain and function.      Improvements among patients with adhesiolysis and hypertonic saline neurolysis and compare to     control group.      Compare adverse event profile in both groups   "
192856|NCT00371007|"     A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2     diabetes mellitus who have inadequate glycemic control on diet/exercise therapy   "
192857|NCT00371020|"     To evaluate the effect of combined 5-FU and low molecular weight heparin in infusion on the     rate of retinal redetachment after silicone oil removal in cases of proliferative     vitreoretinopathy (PVR).   "
192858|NCT00371033|"     The purpose of this study is to determine whether pregabalin is an effective treatment for     Chronic Prostatitis/Chronic Pelvic Pain Syndrome.   "
192859|NCT00371046|"     The objective of this study is to investigate the effect of the use of both sonographic     cervical length (CL) and fetal fibronectin (FFN) on the length of outpatient triage and     preterm labor interventions in symptomatic women with intact membranes.      We performed a randomized trial of the use of transvaginal ultrasound cervical length and     fetal fibronectin in women being evaluated for suspected PTL at a gestational age between 24     and 33 weeks 6 days. Women are randomized to either a standard (blinded) or a protocol arm.     Women in the standard arm are evaluated without the results of the CL and FFN while women in     the protocol arm are evaluated using the results of the CL and FFN and managing physicians     are asked to follow a specific PTL algorithm to determine a women’s eligibility for     treatment. The primary outcome is length of stay in the triage area before discharge.   "
192860|NCT00371059|"     We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the     acute situation i.e under 12 weeks   "
192861|NCT00371072|"     In this randomized clinical trial we compare trabeculectomy with mitomycin-C (T+MMC) and     Ahmed glaucoma implant (AGI) in treatment of aphakic glaucoma in children under 16 years of     age.Complete and qualified success were defined as 5≤IOP≤21mmHg without and with medication     respectively and we came to this point that; T+MMC and AGI are comparable in terms of success     rate and complications in pediatric aphakic glaucoma.   "
192862|NCT00371085|"     Heart failure is a very common condition and is one of the main reasons people are admitted     to hospital. There are many things people with heart failure can do to manage their condition     at home. Unfortunately many people do not have enough information to do this and need to come     back to the hospital because their heart failure got worse. This study will look at different     ways to help people learn more about heart failure and how to manage their condition at home.   "
192863|NCT00371098|"     Background: Influenza vaccination is recommended in patients (pts) with cardiovascular     disease, however there is a shortage of clinical studies proving its protective effect on     clinical course of coronary artery disease (CAD). The aim of the study was to evaluate the     effect of influenza vaccination on the incidence of coronary events in pts with CAD confirmed     by coronary angiography.   "
192864|NCT00371111|"     Cystoid macular edema (CME) is one of the common causes of vision loss in patients with     UveitiS .Triamcinolone has been effectively used in reducing CME and improving the vision.     Also there are some documents which recommend Bevacizumab(avastin) could reduce macular     edema. This study compare intravitreous injection of triamcinolone and avastin in patients     with resistant uveitic cystoid macular edema.   "
192865|NCT00371124|"     The purpose of this study is to find an optimal dose of atropine for preventing the rapid     progression of myopia in children by comparing the efficacy, safety and functional impact of     binocular treatment with 0.5%, 0.1% and 0.01% atropine and to develop a treatment regimen for     the routine management of childhood myopia.   "
192866|NCT00371137|"     The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to     placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled,     parallel group trial.   "
192867|NCT00371150|"     The purpose of this clinical research study is to develop observational clinical experience     with the use of entecavir in participants who are either of Black/African-American race or of     Hispanic ethnicity.   "
192868|NCT00371163|"     Spongiotic dermatitis is the histopathologic diagnosis commonly issued by dermatopathologists     that encompasses atopic dermatitis, contact dermatitis, and other forms of eczematous     dermatitis.      The information obtained will assist in development of diagnostic methods for differentiation     of the types of spongiotic dermatitis. This study also has the potential to lead to the     dissection of pathologic pathways involved in these diseases and development of novel     therapeutic agents.   "
192869|NCT00371176|"     The primary aim of this project is to examine whether administration of D-Cycloserine (DCS),     a partial N-methyl-D-aspartate (NMDA) receptor agonist that has been shown to facilitate fear     extinction, enhances the therapeutic benefit of exposure-based cognitive behavioral therapy     (CBT) in OEF/OIF veterans with PTSD.   "
192870|NCT00371189|"     Malaria is caused by a parasite carried by a mosquito. Currently, there is no vaccine     licensed to prevent malaria. The purpose of this study is to find the most effective and     safest dose of an experimental vaccine for the treatment of malaria. Participants will     include 72 healthy adults, ages18 to 45, enrolled at Vanderbilt University Medical Center and     Stanford University. Volunteers will receive 3 doses of either the malaria vaccine or placebo     (contains no vaccine) by injection into a muscle at 0, 1 and 6 months. Investigators will     evaluate how the body responds to increasing dosage strengths of the vaccine. Study     procedures include physical exam, multiple blood draws, and completion of a memory aid     (diary). Each participant will be actively involved in the study for about 12 months. Then,     an annual phone call will be made to check for any serious illness events for a period of 5     years.   "
192871|NCT00371202|"     it is a randomized clinical trial to compare deep lamellar keratoplasty (DLK) Using big     bubble technique and Penetrating Keratoplasty (PK) in patients with keratoconus   "
192872|NCT00371215|"     The purpose of this study is to evaluate whether rThrombin is safe when used for controlling     bleeding during skin graft surgery.   "
192873|NCT00371228|"     The purpose of this study is to determine whether the timing of the clamping of the umbilical     cord after delivery has an impact on neonatal hemoglobin and hematocrit, tests that determine     the number of red cells in the blood and their ability to carry oxygen. The study hypothesis     is that delaying cord clamping until cord pulsation has ceased will increase the neonatal     blood volume and thereby increase the hemoglobin and hematocrit.      We propose to recruit 150 women who present for vaginal delivery at Tulsa Regional Medical     Center. Half of the women will be randomly assigned to the immediate clamping group, which     will entail clamping of the umbilical cord within six seconds of delivery of the fetal     shoulders. The other half of the volunteers will be assigned to the delayed clamping group,     which will entail clamping the cord after a palpable pulse has ceased, or after 10 minutes.     The infants of mothers in both groups will have blood drawn for a hemoglobin and hematocrit     at the time of the routine PKU heel stick, usually is performed within 18-24 hours of     delivery.      Statistical differences between the blood counts of infants in the control and study groups     will be compared using independent samples t tests.   "
192874|NCT00371241|"     Infants are placed on ECMO for correction of reversible respiratory failure. Often, because a     few of the reasons for respiratory failure show us similar things in the baby, it is     difficult to determine exactly which is causing the biggest problem. We are now capable of     measuring certain cells and proteins in these infants that may help us more accurately     diagnose the exact problem. We hypothesize that infants placed on ECMO will show unique     antibody-secreting cells responses and patterns of cytokine and chemokine (protein) response     to illness and to the ECMO circuit. If we find unique patterns to these cells or proteins,     they may be able to predict outcomes or guide treatment of these infants.   "
192875|NCT00371254|"     This study will determine whether the investigational drug dasatinib is effective in     treatment of women with progressive advanced triple-negative breast cancer.   "
192876|NCT00371267|"     The purpose of this study is to determine whether telephone-delivered cognitive behavior     therapy is effective in the treatment of chronic pain. To examine the effectiveness of this     approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of     age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA     Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs)     in Santa Rosa, San Bruno, Ukiah, and Eureka.   "
192877|NCT00371280|"     Pegging the hydroxyapatite for increasing prosthetic motility sometimes leads to some     complications for the patient. These complications ranging from discharge, granuloma     formation, exposure, implant infection to socket discomfort and etc. We are going to compare     prosthetic motility, objectively and subjectively (patients satisfaction) before and after     pegging the hydroxy- apatite, and evaluate the complications after pegging.   "
192878|NCT00371293|"     Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person's breathing is     restricted during sleep. Obese individuals with OSA are at an increased risk of inflammation     and heart conditions, but it is unknown whether this risk is related to the effects of OSA or     obesity. This study will evaluate whether OSA or obesity plays the primary role in     inflammation related to heart disease. The study will also determine the independent effects     of OSA and obesity on insulin resistance and blood vessel function.   "
192879|NCT00371306|"     Pregnant women with gestational or Type 2 diabetes who require medication are placed in one     of two groups: Insulin injections or Glucovance (oral administration). Blood glucose is     checked 5 times per day, and medication adjusted by perinatologist according to glucose     levels. The hypothesis is that patients will have similar or improved blood glucose control     on an oral agent as compared to control on insulin.   "
192880|NCT00371319|"     The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil     for the initial therapy of active lupus glomerulonephritis.   "
192881|NCT00371332|"     The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with     moderate to advanced periodontal disease   "
192882|NCT00371345|"     This study will determine whether the investigational drug dasatinib is effective in     treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer   "
192883|NCT00371371|"     The purposes of this study are to determine whether intra-arterial injection of autologous     stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem     cell dysfunction in patients with CLI, and to relate the stem cell function with clinical     outcome.   "
192884|NCT00371384|"     This study will evaluate the effectiveness of two types of massage therapy for treating     chronic low back pain.   "
192885|NCT00371397|"     This study is designed to examine the impact of hatha yoga on immune and hormonal functioning     in healthy individuals.   "
192886|NCT00371410|"     Macular edema constitutes the primary cause of visual impairment in diabetic patients with a     disease duration of 20 years or more. Intravitreal triamcinolone (IVTA) and macular focal     laser photocoagulation were reported to generate favorable results in the treatment of     diabetic macular edema, but there have been patients with diffuse diabetic macular edema     refractory to such treatment modalities. The present study will test the safety and the     efficacy of the combined treatment of vitrectomy, IVTA and macular focal laser     photocoagulation in the treatment of intractable diffuse diabetic macular edema.   "
192887|NCT00371423|"     TAXUS ATLAS Direct Stent is a global, multi-center, single-arm, noninferiority trial     comparing results from patients in whom the TAXUS Liberté stent was directly implanted     (direct stenting) versus results from patients in whom implantation with the TAXUS Liberté     stent was preceded by balloon angioplasty (pre-dilatation). The Control group consists of     patients in the main TAXUS ATLAS trial, in which pre-dilatation was mandatory. The primary     objective is to compare outcomes of direct stenting with balloon catheter pre-dilatation. The     primary hypothesis is that late outcomes with direct stenting of the TAXUS™ Liberté     Paclitaxel-Eluting Coronary Stent System will be non-inferior to conventional implantation     with balloon catheter pre-dilatation   "
192888|NCT00371436|"     The purpose of this multi-site randomized clinical study is to test a model treatment program     in a VA Audiology clinic, to evaluate its efficacy, ease of implementation, and acceptability     to audiologists.   "
192889|NCT00371449|"     The primary complaint of individuals with hearing loss is difficulty understanding speech in     the presence of background noise. Although hearing aids help individuals understand speech in     background noise better, there is a high rate of hearing aid rejection in part due to     continued difficulty understanding speech in complex listening situations. The results of     this study may demonstrate that speech-in-noise test results can be a predictor of hearing     aid success. The results of this study also may lead to further studies that can evaluate     interventions to improve hearing aid success for individuals who are identified as     unsuccessful hearing aid users.   "
192890|NCT00371462|"     The purpose of this study is to determine whether including a PDA decision support tool plus     distance support enhances the outcomes attainable by the MOVE2! (Managing Obesity for     Veterans Everywhere) standard care alone. Primary hypotheses are that obese patients with     chronic pain who are randomized to MOVE2! + PDA + Support will a) lose more weight by 6     months, b) show greater maintenance of weight loss at 12 months, and c) display greater     reduction in pain intensity and pain-related disability than those randomized to Standard     Care. Secondary hypotheses are that MOVE2! + PDA + Support, compared to Standard Care will     result in: a) improved quality of life, b) greater treatment adherence, and c) reduced care     utilization.   "
192891|NCT00371475|"     TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results     from patients treated with the TAXUS Liberté 38 mm stent to an historical TAXUS Express     control. The control group is a case-matched, blended, long lesion subset population of TAXUS     Express patients from the TAXUS IV and TAXUS V de novo clinical trials. The objective of the     study is to evaluate clinical outcomes of TAXUS Liberté-SR 38 mm stent in de novo lesions and     to assess the non-inferiority of TAXUS Liberté versus TAXUS Express. The TAXUS Liberté-SR     stent is hypothesized to have comparable safety and efficacy to the TAXUS Express stent.   "
192892|NCT00371488|"     This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best)     doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the     tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and     trastuzumab.   "
192893|NCT00371501|"     The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can     reduce the progression of subclinical atherosclerosis in patients with systemic lupus     erythematosus (SLE).   "
192894|NCT00371527|"     ABSTRACT CONTEXT: Inappropriate antibiotic prescriptions for acute bronchitis is a major     public health concern because of antibiotic resistance. Effective therapies for managing the     symptoms of acute bronchitis are lacking, however.      OBJECTIVE: Determine if patients with acute bronchitis have better symptom control when     treated with inhaled ipratropium.      DESIGN, SETTING, PARTICIPANTS: COUGH STOP was a randomized, double blind, placebo controlled     trial comparing ipratropium with placebo in acute bronchitis. Subjects were referred by their     primary care provider or from urgent care clinics at a single institution. Subjects had been     diagnosed with acute bronchitis and had no significant co-morbidities.      INTERVENTION: Subjects received ipratropium or placebo inhalers, administering 2 puffs four     times daily. A structured telephone interview took place 2, 4, and 8 days after enrollment.     Medical records were reviewed at 60 days.      OUTCOME: The primary endpoint was improvement in cough symptomology; secondary endpoints     included subsequent antibiotic prescriptions and well being.   "
192895|NCT00371540|"     The objective of this application is to develop and assess a system which uses non-clinician     extenders to provide selected aspects of HIV care in rural western Kenya. The plan is to     train persons living with HIV/AIDS (PLWAs) to undertake this role as Community Care     Coordinators. Our central hypothesis, is that PLWAs can be effective members of the health     care team and that their involvement in community-based HIV care will facilitate patient     access to services and improve outcomes. As such our two specific aims are: 1) To develop a     sustainable system to extend HIV care into the community and to train the individuals     necessary to support such a system (Community Care Coordinators). 2) To determine the impact     of Community Care Coordinators on patient adherence (to drugs and to clinic visits), clinical     outcomes (i.e. viral load responses [an individuals level of circulating HIV virus],     inter-current opportunistic infections, hospitalization, drop out from the program, change to     second line therapy and mortality) and patient perception of stigma. This study will provide     invaluable data on the use of non-clinician care extenders for providing HIV care in resource     poor settings. As such, knowledge gained from this study will assist in developing a model     for non-clinician centered HIV care systems elsewhere in sub-Saharan Africa.   "
192896|NCT00371553|"     The purpose of this study is to investigate the activity of SU011248 in subjects with     cisplatin-refractory or multiply relapsed germ cell cancer. It is believed that SU011248     treatment may prove to increase disease response.   "
192897|NCT00371566|"     This is a study comparing the activity of lapatinib versus placebo followed by     chemoradiation. This study is designed to explore the effects of lapatinib monotherapy on     apoptosis/necrosis, in pre-treatment and post-treatment tumour tissue samples in subjects     with locally advanced squamous cell carcinoma of head and neck.   "
192898|NCT00371579|"     Objective: Determine if maximum doses of rosuvastatin are safe in patients infected with     hepatitis C and if the so called pleiotropic effects of rosuvastatin cause a decrease in the     HCV viral load.      Primary study parameters: 1. to which extend causes rosuvastatin serious side effects like     rhabdomyolysis and hepatotoxicity in patients chronically infected with hepatitis C? 2. does     treatment with rosuvastatin in HCV infected patients lead to lower HCV-RNA viral load? 3. Is     a decrease in LDL correlated to a decrease in HCV-RNA load?   "
192899|NCT00371592|"     The purpose of this study is to determine whether acyclovir is effective in suppressing HIV     viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are     starting HIV treatment for the first time.   "
192900|NCT00371605|"     A fixed-dosing regimen of voriconazole is routinely used as prophylaxis against aspergillosis     in liver transplant patients admitted to the transplant intensive care unit at UPMC. We     hypothesize that use of a fixed-dosing regimen of voriconazole will lead to a large degree of     variability in drug exposure among liver transplant patients due to: 1) variability in     absorption and elimination caused by physiological characteristics unique to this patient     population 2) its non-linear pharmacokinetics and 3) the potential for polymorphism in the     genes that encode for cytochrome P-450 enzymes that metabolize voriconazole. This is a pilot     clinical pharmacokinetic evaluation that will: 1) characterize the plasma concentration     versus time profile of voriconazole in liver transplant patients receiving a fixed-dosing     regimen to assess for extremes in systemic exposure 2) determine the oral bioavailability of     voriconazole in liver transplant patients 3) assess for functionally significant allelic     variation of the cytochrome P-450 enzymes that metabolize voriconazole (CYP2C9, CYP2C19 and     CYP3A4/5) in both recipient blood and allograft tissue that may contribute extremes in     systemic exposure among liver transplant patients. This evaluation will allow for an     assessment of the adequacy of the prophylactic regimen in achieving therapeutic drug     concentrations in all subjects. Additionally, the utility of genotyping as a clinical tool to     identify patients at risk for extremes in voriconazole exposure will be evaluated. The     characterization of the pharmacokinetics in liver transplant patients may be utilized to     define an optimal therapeutic regimen that will be individualized to target specific     concentrations to maximize efficacy and minimize side-effects.   "
192901|NCT00371618|"     To determine clinically significant improvement in the patients undergoing procedures under     fluoroscopy.      To evaluate and compare the adverse event profile in both groups   "
202057|NCT00492479|"     The purpose of this study is to compare the efficacy of the Kinerase Pro+Therapy regimen     versus a single Kinerase product vs. control for the treatment of the signs of skin aging.   "
192904|NCT00371657|"     The purpose of this retrospective pilot study is to address the effect that obesity, in the     absence of other comorbidities, has on birth weight. We wish to determine if obesity is a     risk factor for small for gestational age (SGA) or intrauterine growth restricted (IUGR)     infants in our clinic population. There have been many studies linking maternal obesity with     fetal macrosomia, defined as fetal birth weight greater than 4500 grams. However, we have     noted that a percentage of our obese patient population has delivered either an SGA or IUGR     infant. SGA refers to a constitutionally small infant weighing less than the 10th percentile     for age. This refers to a genetically normal infant. IUGR refers to a fetus whose growth has     been restricted by influences other than normal genetics.      Our study population will consist of all women over the age 18 who delivered a term infant     either by vaginal delivery or cesarean section at Tulsa Regional Medical Center between July     1st 2004 and December 31st 2005.      The diagnosis of obesity will be based upon a Body Mass Index (weight in kilograms/height in     meters squared) of thirty or greater. We will look at the infant birth weight as recorded in     the patient's chart. We will define SGA or IUGR as birth weight less than the 10th percentile     for gestational age as defined previously. The control group will consist of women meeting     the same criteria except they will have a BMI less than thirty but greater than 19.8 as low     maternal weight is also a risk factor for IUGR. We will compare the average birth weight and     the rates of SGA/IUGR infants between the two groups and analyze using the chi-squared method     of analysis.   "
192905|NCT00371670|"     This study will test efficacy and safety of AAE581 compared to placebo in limiting cartilage     loss in patients with painful knee osteoarthritis which is confirmed by X-ray   "
192906|NCT00371683|"     The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep     vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee     replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for     preventing these clots. The safety of apixaban will also be studied.   "
192907|NCT00371696|"     The aim of this study was to provide essential pilot data on the feasibility of conducting     n-of-1 trials within secondary care within the UK, notably to: test the process of     recruitment and design aspects of such trials; assess the acceptability of this research     method to patients, explore the experiences of patients involved; determine the most     appropriate treatment for individual patients.   "
192908|NCT00371709|"     TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results     from patients treated with the TAXUS Liberté stent to an historical TAXUS Express control.     The control group is a case-matched, blended population of TAXUS Express patients from the     TAXUS IV and TAXUS V de novo clinical trials. The objective of the study is to evaluate     clinical outcomes of TAXUS Liberté-SR stent in de novo lesions and to assess the     non-inferiority of TAXUS Liberté versus TAXUS Express. The TAXUS Liberté-SR stent is     hypothesized to have comparable safety and efficacy to the TAXUS Express stent.   "
192909|NCT00371722|"     Women having cesarean section will be divided into two groups - cesarean section alone or     cesarean section with appendectomy. The purpose is to see if the appendectomy can be done     without adding any complications to the maternal post-operative course. The hypothesis is     that there is no increased incidence of wound infection, post-operative morbidity or longer     hospital stay associated with elective appendectomy at the time of Cesarean Section.   "
192910|NCT00371735|"     CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a     public-private partnership with the Medicines for Malaria Venture (MMV), World Health     Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical     Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a     treatment for acute uncomplicated P. falciparum malaria.      The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has     already been shown to be efficacious against P.falciparum in adults and children in     Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase the     parasite kill rate as demonstrated in the phase II study, and reduce the chance of any     parasites escaping treatment over the 3-day course. The addition of artesunate is also     anticipated to have the population benefit of protection against the development of resistant     strains of P.falciparum, although it will not be possible to demonstrate this in a clinical     trial. One further population benefit of the artemisinin drugs are their ability to suppress     the sexual forms of the parasite (gametocytes), which should reduce infectivity after     antimalarial treatment and potentially lower transmission rates with widespread use,     including the spread of any parasites resistant to the partner drug.      The aims of this phase III study are to compare the efficacy of a fixed ratio combination     tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a     multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and     adults, with chlorproguanil-dapsone as a comparator.   "
192911|NCT00371748|"     TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients with     coronary arteries less than 2.5 mm in diameter who are treated with the TAXUS Liberté stent     versus an historical TAXUS Express control derived from a subset of lesion-matched TAXUS V     patients treated with a 2.25 mm stent. The objective of the study is to evaluate clinical and     angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions. The hypothesis is     that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR     stent in the treatment of de novo lesions in small coronary vessels.   "
192912|NCT00371761|"     This is an open label, randomized, comparative, multi-center study. Subjects will be screened     within 2 weeks prior to study entry to establish eligibility. Subjects who meet all the     selection criteria will be randomly assigned 1:1 to (1) once-a-week, subcutaneous Pegylated     interferon alfa-2b (PegIntron) (1.5 mcg/kg body weight) or (2) oral adefovir 10 mg daily. The     treatment phase will be 24 weeks for PegIntron and 48 weeks for adefovir. All subjects     completing the assigned treatment phase will be followed up for an additional 48 weeks for     PegIntron and 24 weeks for adefovir as observation phase. The primary objective is to     establish the efficacy profile of PegIntron. Secondary objectives are to compare the efficacy     profile of PegIntron with that of adefovir, compare efficacy of PegIntron in lamivudine-naïve     and lamivudine-experienced subjects, and to establish the safety profile of PegIntron in     treating patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.   "
192913|NCT00371774|"     Purpose:      To develop a real time national clinical database to support and share best practices,        1. To generate hypotheses for future clinical research        2. To understand how AMEVIVE is used in routine clinical practice/real world setting.      Each patient visit will include the following observational endpoints:        1. AMEVIVE dosing        2. Number of courses        3. Concomitant treatment        4. Response to treatment (patient and physician global assessments)        5. Status of other psoriasis-related medical conditions        6. Time to re-treatment.   "
192914|NCT00371787|"     To evaluate the performance of the study soft lens for vision, comfort, physiology and lens     surface properties.   "
192915|NCT00371800|"     the purpose of this study is to determine if cinnamon improves glucose control among     adolescents with type 1 diabetes mellitus.   "
192916|NCT00371813|"     To investigate safety and efficacy of varenicline tartrate in helping people quit smoking   "
192917|NCT00371826|"     The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation     versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure     cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium     (EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will     be compared to a third control group, who will receive treatment consisting of cyclosporine     micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.   "
192918|NCT00371839|"     The purpose of this study is to determine the effects of age-related cognitive changes on     hearing aid benefit based on hearing aid compression time constants.      The hypothesis is that people with poor working memory skills will benefit from slow time     constants in hearing aid compression while those with good working memory skills will be able     to benefit from more sophisticated compression algorithms with rapid time constants.   "
192919|NCT00371852|"     The purpose of this study is to demonstrate the absence of irritation potential (primary     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the     product Dermacyd wipes.   "
192920|NCT00371865|"     The purpose of the study is to test a brief, group-administered psychosocial intervention to     reduce interference of pain with daily life, emotional distress, and pain intensity, and     improve quality of life and physical activity levels in individuals with chronic pain.   "
192921|NCT00371878|"     Lung immune responses are regulated independently of systemic responses. Injected vaccines     may induce optimal responses in blood but not at mucosal surfaces. We compared the responses     in serum and lung fluid to injected pneumococcal conjugate vaccine.   "
192922|NCT00371891|"     Multidetector Computed Tomographic Coronary Angiography (MDCTCA) has been recently     demonstrated to be accurate and may be used as a potential alternative to conventional     invasive coronary angiography, which requires cardiac catheterization, for the diagnosis of     coronary artery disease. The purpose of this study is to see if MDCTCA can identify     significant coronary artery disease as good as or better than conventional coronary     angiography (CICA). The study is designed to enroll 900 subjects and is being conducted in 6     hospitals in Ontario. Subjects scheduled for conventional cardiac catheterization and     coronary angiography will receive an additional test using MDCTCA. The information gathered     during the MDCTCA will be compared to the results of the scheduled conventional invasive     coronary angiogram.   "
192923|NCT00371904|"     About one third of prospective kidney transplant recipients have antibodies in their blood     directed against the tissues of their only available kidney donor. Recently,     desensitisation treatments when administered pre-transplant have allowed successful     transplantation of these patients despite high rates of acute antibody mediated rejection     (AAMR). The investigators propose to test in a randomised controlled trial whether rituximab,     a monoclonal antibody that depletes B-lymphocytes, will safely lower antibody mediated     rejection (AMR) rates when added to standard therapy. The investigators will also test     whether rituximab enables more patients to achieve a negative crossmatch against their donor     and thereby allow more transplants to proceed.   "
192924|NCT00371930|"     24 test persons are treated with a dye suspension followed by a laser intervention. A     decrease of hair density is expected.   "
192925|NCT00371943|"     Both medications with beta-blockers and isosorbide-5-mononitrate and endoscopic variceal     ligation have been proven plausible in the prevention of variceal rebleeding. However, the     relative efficacy and safety of the combined treatment for preventing rebleeding remains     unresolved.   "
192926|NCT00371956|"     This study is a double-blind placebo-controlled trial evaluating the efficacy of raloxifene     in the prevention of bone mineral density loss in patients receiving long term     corticosteroids.   "
192927|NCT00371969|"     The main aim of this study is to test an intervention to reduce unsafe drinking among     HIV-positive primary care patients. The intervention consists of a brief motivational     interview, which is combined with daily alcohol monitoring through the use of an interactive     voice response system IVR (automated telephone system). Subjects who receive the enhanced     motivational interview are expected to show greater improvements in drinking than individuals     who receive the standard motivational interview or view a DVD on HIV self-care.   "
192928|NCT00371982|"     1. whether the intake of n-3 PUFA has additional effects on insulin sensitivity and          adiposity (total fat mass and adipocyte morphology and function) in T2D women.        2. n-3 PUFA supplementation might influence inflammatory genes expression in the adipose          tissue of T2D patients.   "
192929|NCT00371995|"     Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral     leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will     be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six     months.   "
192930|NCT00372008|"     Testosterone replacement treatment is the most effective way of treating hypogonadism in men.     Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this     study will evaluate the efficacy and safety of this product.   "
192931|NCT00372021|"     Non-arthritic anterior ischemic optic neuropathy is the most common cause of sudden visual     loss due to optic nerve involvement in patients above 50 years old. As this problem can be     considered as a sclera out let syndrome an there is no effective and successful treatment for     it, we decided to do a neurotomy procedure and relax the involved optic nerve in order to     achieve acceptable treating outcome.   "
192933|NCT00372047|"     In this study, test persons with chronic excessive UV radiation and a control group are     examined by multiphoton laser imaging and biophysical methods in order to evaluate the dermal     fiber network. We expect to observe signs of advanced skin aging in the test group.   "
192934|NCT00372060|"     The clinical study determines the safety and efficacy of MK0431 in patients with type 2     diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.   "
192935|NCT00372073|"     This is a randomized Phase II study of an experimental anti-cancer drug called seliciclib.     The main objective of this study is to learn if, and how long, seliciclib can keep the     non-small cell lung cancer in check.      An experimental drug is a drug which has not been approved by the U.S. Food and Drug     Administration (FDA) or other regulatory agencies for marketing and is still under study to     determine how safe it is, what its side-effects are, and whether or not it is effective in     the treatment of non-small cell lung cancer.   "
192936|NCT00372086|"     Type 1 Diabetes is the most common life-long disorder with onset in childhood. Patients need     insulin injections, blood sugar monitoring several times each day, and adhere to a strict     diet. Adequate control of blood glucose is essential to prevent long term kidney and eye     complications that result in kidney failure and blindness. Adolescence is a time when     diabetes is difficult to control, due in part to high growth hormone levels causing insulin     resistance ( a state where the body does not respond as strongly to insulin). This study will     test whether treatment with rosiglitazone (an oral medication used frequently in type 2     diabetes) will reduce the insulin resistance of adolescence and improve the control of type 1     diabetes during puberty.   "
192937|NCT00372099|"     Calcitonin has been used for many years for treating osteoporosis in postmenopausal women.     Recent data from the 2 years placebo-controlled QUEST study have shown a preservation of     microarchitecture as measured by high resolution MRI in postmenopausal women with prevalent     vertebral fractures at baseline.This pilot study should provide additional new insights in     the mode of action of nasal calcitonin, on structural changes as measured by high resolution     peripheral CT, and on the comparison between weight bearing and non weight bearing bones in     postmenopausal women.   "
192938|NCT00372112|"     The compound GW642444 has previously been found to be well tolerated with no significant side     effects in subjects with asthma and healthy volunteers. This study will assess the safety and     tolerability of GW642444 in subjects with COPD in order to obtain information to support     dosing in a broader population of subjects with COPD   "
192939|NCT00372125|"     The aim of this study is to study the effects of GH on body composition, lipid and glucose     metabolism, physical performance and safety aspects in adults with PWS.The patients are     randomized to either GH or placebo the first year of the study, subsequently followed by two     years of GH treatment. the study is performed in Norway, Sweden and Denmark.   "
192940|NCT00372138|"     The main risk of aortic aneurysms is rupture that leads to a high risk of death. A preventive     surgical treatment is thus needed. In order to reduce the morbidity and mortality associated     with conventional surgery, an endovascular approach (insertion of an endovascular stent     graft)is now widely favored. The main problem of this procedure is the occurrence of     endoleaks (persistence of a communication between the aneurysm and the aorta). A new approach     is proposed to prevent these endoleaks. The principle is to draw blood from the patient,     separate the blood from the platelets, and reinject both platelet rich plasma (PRP) and     autologous thrombin, in order to form a platelet gel (PRP + autologous thrombin). Before     studying the efficacy of this technique, its safety of use and feasibility must be evaluated.   "
192941|NCT00372151|"     The aim of the proposed study is to investigate the efficacy and safety of add-on     gamma-glutamylethylamide (L-theanine) versus a placebo for antipsychotic treatment for 8     weeks in a randomized, double-blind, parallel group study of 60 patients with schizophrenia     and schizoaffective disorders.   "
192942|NCT00372164|"     To demonstrate clinically significant improvements in the patients treated following ASIPP     guidelines compared to the patients who were treated prior to the establishment of ASIPP     guidelines.   "
192943|NCT00372177|"     Rheumatoid arthritis (RA) is a disease with a large economic impact due to the long lasting     disabling nature of the disease. Furthermore, diagnosis of the disease is difficult and only     a scheme with different symptoms is used to diagnose rheumatoid arthritis, often only by     probability.      Due to the fact that effective disease modifying pharmacological treatment is available and     should be started early in established cases of RA, in combination with the adverse effect     potential of these substances (e.g. methotrexate), a fast reliable diagnostic tool to     diagnose rheumatoid arthritis would be highly appreciated by the medical community and the     patients. Furthermore, for invasive treatments (surgery, puncture), an imaging method to     display the activity pattern in different joints would be a major advantage.      For the evaluation of the effectiveness of pharmacological therapy in rheumatoid arthritis,     up to now, radiological measurements of the destruction process of the joints are used. This     method has the disadvantage that it is time consuming insofar as changes in the radiological     images must occur. It allows only an evaluation if the joints are destructed (which should be     excluded by the new therapy regimen). Again, a quantifiable method for the determination of     the effects of new therapeutic approaches would be highly appreciated.   "
192944|NCT00372190|"     Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The     recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a     mesh aims at reducing the recurrence rate, but mesh implants can cause complications.      This study is designed to determine the effectiveness of one type of mesh (tensionfree     vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is     to track the complications of both procedures.   "
192945|NCT00364689|"     The purpose of this study is to compare the effectiveness of three different treatments for     hepatic encephalopathy. These treatments are:        -  Group 1 - lactulose given with a rifaximin placebo (sugar pill)        -  Group 2 - lactulose given with rifaximin        -  Group 3 - rifaximin given alone      The goals of this study are to determine which treatment is most effective at (1) reducing     admissions to hospital for hepatic encephalopathy and (2) improving mental function, during     the study period.   "
192946|NCT00364702|"     Using a virtual reality program in screening and treatment of ADHD.   "
192947|NCT00364715|"     Recent studies have shown that dysregulation of ANXA1 expression are associated with     tumorigenesis. Overexpression of ANXA1 protein is found in a wide variety of human tumors,     such as breast 10, liver 11, pancreatic cancer14 and glial tumors15. In contrast, reduced     levels of ANXA1 protein expression have been reported in ESCC4, 5, gastric6, breast7, head     and neck SCC8 and prostate cancer9. No previous study on ANXA1 protein expression has been     reported in the cancer of oral cavity. Furthermore, although alterations in annexin     expression in different types of tumors have been described, no correlation has been     established between ANXA1 and overall patient survival yet.      ANXA1 is a major cellular substrate of the oncogenic tyrosine kinases such as EGF receptor     and hepatocyte growth factor (HGF) receptor, c-met. Previously, we have shown that expression     of HGF and c-met is significantly associated with the progression of OSCC in Taiwan.     Kermorgant et al. recently showed that PKC controls HGF-dependent c-met traffic, signaling     and cell migration. Prior study indicate that the mitogen phorbol-12-myristate 13-acetate     (PMA) induced ANXA1 nuclear translocation in a PKCdelta-dependent manner and ANXA1 nuclear     translocation may participate in the regulation of cellular proliferation and the     differentiation. However, it is not known whether HGF can induce ANXA1 nuclear translocation     or not and how this relates to the pathogenesis of oral SCC.      In this study we aimed to investigate whether HGF induced the translocation of ANXA1 protein     to the nucleus in OSCC cells and the role(s) of ANXA1 nuclear localization in the     carcinogenesis of OSCC using an immunohistochemical technique. The data suggest a novel     mechanism for HGF-induced ANXA1 protein nuclear translocation that may play an important role     in the pathogenesis and prognosis in oral SCCs.   "
192948|NCT00364728|"     Over the past few years, growing evidences revealed that clearance of apoptotic cells by     phagocytosis can result in powerful anti-inflammatory and immunosuppressive effects. In vivo,     apoptotic cells are cleared rapidly by neighboring cells, macrophages and related scavengers.     Defective clearance of apoptotic cells has been linked closely to autoimmunity and persistent     inflammatory disease. Several phagocytic receptors, bridging molecules produced by phagocytes     and 'eat-me' signals on apoptotic cells are coordinately involved in mediating clearance of     apoptotic cells. Complement receptors (CR3, CR4), collection, CD14, CD36 (Class B scavenger     receptor), class A scavenger receptor, asialoprotein receptor, Mer receptor kinase were     reported to recognize apoptotic cells. The best characterized system for clearance of     apoptotic cells is the recognition of phosphatidylserine (PS) on apoptotic cells by     phosphatidylserine receptor (PSR). Milk fat globule- epidermal growth factor 8 (MFG-E8) is an     opsonin that bridges phagocytes (by interacting with α vβ3, αvβ5 integrins via RGD motif) and     apoptotic cells (by binding PS through Factor V/VIII-C domain). Activated macrophages produce     and secret MFG-E8. MFG-E8 is a critical component in PSR-mediated phagocytosis of apoptotic     cells. The dominant negative mutant MFG-E8, D89E, that carried a mutated RGD motif inhibited     phagocytosis of apoptotic cells in vitro. Injection of D89E into wild type mice induced     autoantibodies and IgG deposition on glomeruli. Macrophages from MFG-E8 deficiency     (MFG-E8-/-) mice were impaired in engulfment of apoptotic cells, which can be restored by     adding recombinant MFG-E8. The female MFG-E8-/- mice spontaneously produced high titer of     autoantibodies and developed lupus-like glomerulonephritis at the age of week 40. Defective     clearance of apoptotic cells is closely related to development of autoimmunity. In the past 4     years, a growing number of molecules were recognized as receptors for the PS exposed on the     apoptotic cells. These molecules were capable of mediating phagocytic clearance, rendering     anti-inflammatory cytokines in the phagocytes, and modulating T cell responses.      The specific aim of this proposal is to study genetic polymorphism in MFG-E8, PSR and other     factors implicated in phagocytic clearance of apoptotic cells among Taiwanese. By comparing     the polymorphism between patients with autoimmune disease (SLE or RA) and healthy control     subjects, we will investigate if genetic variations among individuals of genes encoding     proteins involved in clearance of apoptotic cells contribute to the pathogenesis of systemic     autoimmune diseases SLE and RA.   "
192949|NCT00364741|"     Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as     opposed to normally 30%) on surgical wound infection and pulmonary complications after     abdominal surgery.      Background: Surgical wound infection is a common and serious complication. Tissue oxygen     tension is often low after surgery and the resistance against infection depends on this     factor through bacterial killing by neutrophils. Oxygen is a substrate in this reaction, and     it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound     infection is reduced. Previous studies to test this hypothesis have shown entirely different     results. Hence, the clinical decision between high and normal oxygen concentration is still     controversial.      Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical wound     infection after abdominal surgery.      Secondary objectives: To investigate the effect 80% oxygen on pulmonary complications     (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length     of postoperative hospitalization and admission to intensive care unit after abdominal     surgery.   "
192950|NCT00364754|"     This is a Phase I, multi-centre, open-label, cross-over pharmacokinetic study designed to     investigate whether the co-administration of a fixed dose of tesmilifene alters the plasma     pharmacokinetics of a standard regimen of epirubicin and/or its principle metabolite,     epirubicinol and cyclophosphamide.   "
192951|NCT00364767|"     Moderate alcohol consumption is associated with a decreased risk of diabetes type 2. This     association could be mediated by an improvement of insulin sensitivity with moderate alcohol     consumption. Patients with diabetes type 2 or impaired glucose tolerance often may have     decreased fat oxidative capacity or oxidative phosphorylation in tissue such as muscle. This     could lead to accumulation triglyceride storage in muscle, which could interfere with insulin     signaling. Whether such mechanism can also play a role with moderate alcohol consumption is     unknown and will be investigated in this study.      In addition, moderate alcohol consumption with a meal can lead to delayed hypoglycemia in     type 1 diabetes patients. How moderate alcohol consumption affects postprandial glycemic     response in healthy subjects is unknown. This is a secondary objective of this trial.   "
192952|NCT00364780|"     The purpose of this phase II study is to determine the safety, tolerability, and activity of     XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a     small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2     (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR     mutations and associated with certain clinical characteristics in patients with NSCLC (eg,     female, minimal and remote smoking history, and adenocarcinoma histology).   "
192953|NCT00364793|"     The primary purpose of this study is to find the dose of Efavirenz for young children. The     safety and how the medication is tolerated will also be studied.   "
192954|NCT00364806|"     Migraine headaches are a common reason for patients to present to an emergency department. We     are comparing two different medications to see which one is better for patients who present     ot an emergency room with a migraine headache.   "
192955|NCT00364819|"     The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in     treating patients with Primary Biliary Cirrhosis (PBC). Rituximab is a laboratory-made     antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with     PBC, a disease of the immune system. However, the safety of rituximab in PBC patients must     first be established.   "
192956|NCT00364832|"     This study will determine the appropriate dose and frequency of administration of sc Mircera     maintenance therapy in dialysis patients with chronic renal anemia who were previously     receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and     the target sample size is 100-500 individuals.   "
192957|NCT00364845|"     Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety     follow up phase of 52 weeks   "
192958|NCT00364858|"     This is a multicenter, randomized trial to compare the safety and efficacy of two dosing     frequencies of Cerezyme® in patients with Gaucher disease who are currently being treated     with Cerezyme®.      Approximately 90 patients will be randomized in a 2:1 (q4 : q2) ratio to one of two treatment     arms at up to 26 study centers worldwide. Patients will continue to receive the same total     4-week dose that they were receiving prior to study enrollment, however, they will be     randomized to receive either their total 4-week dose in two infusions, one infusion every 2     weeks or their total 4-week dose in one infusion every 4 weeks. The randomization scheme will     ensure a 2:1 balance between the every 4-week versus every 2-week infusion groups,     respectively.   "
192959|NCT00364871|"     The purpose of this study is to determine the efficacy and safety of 3 combinations of     naltrexone and bupropion SR compared to naltrexone alone, bupropion SR alone or placebo.   "
192960|NCT00364884|"     Keto-/amino acid supplemented low protein diet can reduce uremic symptoms, improve     nutritional status, delay dialysis therapy and enhance health-related quality of life in our     patients with stage V CKD in comparison to non-supplemented low protein diet.   "
192961|NCT00364897|"     Tibial fixation is the weak link when using soft tissue grafts and interference screws for     fixation in a bony tunnel in ACL reconstruction. The Objective is to study two groups of     patients undergoing double loop hamstring autograft ACL reconstruction and compare between     the two tibial fixation devices: the tapered Deltascrew and the Intrafix screw and sheath .   "
192962|NCT00364910|"     This study will evaluate the safety and efficacy of cognitive behavioral therapy in treating     people who are experiencing post-traumatic stress disorder after a heart attack.   "
192963|NCT00364923|"     Primary      • Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid     supplementation when administered to patients with relapsed or refractory peripheral T-cell     lymphoma (PTCL)      Secondary        -  Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid          supplementation when administered to patients with relapsed or refractory PTCL        -  Determine the pharmacokinetic (PK) profile of pralatrexate when administered with          vitamin B12 and folic acid supplementation   "
192964|NCT00364936|"     The primary purpose of this study is to develop, implement and conduct a preliminary     evaluation of a new service for people who are severely affected by multiple sclerosis. The     investigators conducted open interviews with patients, families and staff, plus a literature     review to model and pilot this new service. Then the investigators developed, tested and ran     the service and will evaluate it using a randomised controlled trial, where people affected     by MS are randomised to either receive the service immediately (fast track group) or after a     three month wait (standard best practice). This methodology follows that of the Medical     Research Council (MRC) framework for the development and evaluation of complex services and     treatments. The investigators interview people and their carers in the fast track and     standard practice groups, and followed them over time. This phase of trial enables us to     calculate sample size and test proof of concept for a full randomised trial. However, our     working hypothesis was that there would be no difference between those people who received     the fast track service or the standard best practice in terms of symptom controlled, and     carer needs.   "
192965|NCT00364949|"     Polycystic ovary syndrome (PCOS) is among the most common endocrine disorders in     premenopausal women, affecting 7-10% of this population. This syndrome is characterized by     elevated levels of testosterone and chronic anovulation, and frequently of obesity. This     study is designed to test the hypothesis that there is in utero testosterone excess, altered     insulin secretion, and/or intrauterine growth retardation in the female offspring of women     with PCOS. The allele 8 can be used to identify the reproductive and metabolic abnormalities     associated with PCOS. This study will determine whether allele 8 positive [A8(+)] female     offspring have more profound changes in these parameters compared to A8(-) female offspring.      Androgen and insulin levels in amniotic fluid from pregnant women with PCOS will be compared     to levels in pregnant control women. Androgen and insulin levels in cord blood will also be     measured. Further, gestational age and anthropomorphic measurements in offspring of women     with PCOS will be assessed and compared to that in offspring of matched control women.      We will test the hypothesis that androgens are elevated in infancy in the female offspring of     women with PCOS. We will assess sex steroids, insulin, and c-peptide levels in infants of     PCOS women and compare them to the levels in infants of control women up to 1 year of age     during the minipuberty of infancy. We will determine whether any of these parameters differ     in A8(+) compared to A8(-) PCOS offspring.   "
192966|NCT00364962|"     Investigate the treatment result of KTP laser nasopharyngectomy in recurrent NPC patients   "
192967|NCT00364975|"     Subjects that participate in the practical workshop will improve their metabolic indexes,     control their weight and improve their quality of life, in contrast to the participants that     will take part in the nutritional consulting sessions   "
192968|NCT00364988|"     Peroxisomal proliferator-activated receptor agonist pioglitazone and rosiglitazone are     currently used in the treatment of type 2 diabetes, as efficient insulin sensitizers alone or     in combination with insulin.angiotensin II receptor antagonist losartan reduced the levels of     proteinuria.Whether Combination therapy with pioglitazone and losartan provides additional     renoprotection in subjects with type 2 diabetic nephropathy,it's worth researching.   "
192969|NCT00365001|"     This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in     combination with tocilizumab to assess any potential drug interactions. Patients will be     randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate     (10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and     43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time     on study treatment is <3 months, and the target sample size is <100 individuals.   "
192970|NCT00365014|"     The purpose of this study is to identify and characterize blood diseases presenting at     Shanghai hospitals and to compare them with respect to clinical presentation, phenotype,     molecular characteristics, benzene or other exposures and genetic susceptibility.   "
192985|NCT00365235|"     Familial combined hyperlipidemia (FCHL) is an inherited disorder characterized by elevated     levels of cholesterol and triglycerides; it often occurs in Mexican individuals with coronary     heart disease (CHD). The purpose of this study is to identify the specific genes that     predispose Mexican individuals to FCHL.   "
192971|NCT00365027|"     It has been suggested that in IVF cycles where GNRH agonist is utilized for final oocyte     maturation in patients at risk of ovarian hyperstimulation, pregnancy rates are reduced. We     hypothesize that the use of GNRH antagonist reduces pregnancy rates through an effect on the     endometrium and not oocyte quality, therefore better results may be obtained by not returning     these embryos in a fresh cycle but rather cryopreserving them and returning them to the     uterus and a later stage.   "
192972|NCT00365040|"     The present study was designed to compare the use of mitomycin in PRK for the treatment of     refractive errors and to compare these results to customized Lasik   "
192973|NCT00365053|"     This phase II trial is studying how well PXD101 works as second-line therapy in treating     patients with malignant mesothelioma of the chest that cannot be removed by surgery. PXD101     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and     by blocking blood flow to the tumor.   "
192974|NCT00365092|"     Middle-ear disease (infection and fluid) is the most common illness in young children after     the common cold. Because hearing loss accompanies middle-ear disease, and because early life     is a period of rapid development, concern has existed that sustained periods of middle-ear     disease might cause lasting impairments of learning, speech development, language     development, or behavior and social adjustment. Earlier phases of this research found that     the insertion of ear tubes in children younger than 3 years of age with persistent middle-ear     disease did not affect their development at 3, 4, or 6 years of age. This study examines the     children's literacy, attention, and related abilities at 9 to 11 years of age.   "
192975|NCT00365105|"     RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other     symptoms caused by bone metastases. It is not yet known whether giving zoledronate together     with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in     treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer.      PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to     see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89     or samarium 153 in preventing or delaying bone problems in patients with bone metastases from     prostate cancer, lung cancer, or breast cancer.   "
192976|NCT00365118|"     The purpose of the trial is to compare efficacy and adverse effects of pulsed dye laser and     intense pulsed light in patients with port wine stains.   "
192977|NCT00365131|"     This is a multicenter, open-label, prospective study of the efficacy of Cerezyme in treating     patients with skeletal manifestations secondary to Type I Gaucher disease.      The study objective is to evaluate and quantify skeletal responses as compared to baseline in     Type I gaucher disease patients receiving Cerezyme therapy for 48 months. Additional     objectives were to assess the usefulness of various skeletal parameters, such as bone pain,     bone crises, bone mineral density, and serum and urine bone markers, as indicative of     treatment response and may be useful in dose management.   "
192978|NCT00365144|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of pancreatic cancer by blocking blood flow to the tumor. Erlotinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     bevacizumab together with erlotinib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib     works in treating patients with metastatic pancreatic cancer that did not respond to previous     treatment with gemcitabine.   "
192979|NCT00365157|"     This phase I/II trial studies the side effects and best dose of eribulin mesylate and to see     how well it works in treating patients with cancer of the urothelium that has spread to     nearby tissue or to other places in the body and kidney dysfunction. Drugs used in     chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Chemotherapy drugs may have different effects in patients who have changes in     their kidney function.   "
192980|NCT00365170|"     This trial was conducted in Europe, Middle East, North America and South America.      The aim of this trial was to compare the use of an intensified insulin treatment with insulin     aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.   "
192981|NCT00365183|"     The goals of this study are:        -  to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may          be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have          had one previous chemotherapy regimen that included a platinum containing drug such as          cisplatin or carboplatin.        -  to assess response to treatment in patients with NSCLC six months after beginning study          treatment.   "
192982|NCT00365196|"     Individuals who experience high hostility levels may be more prone to developing coronary     artery disease (CAD) than individuals who experience low hostility levels. This study will     evaluate the effectiveness of a hostility reduction treatment program on the body's ability     to regulate heart activity in individuals with high levels of hostility.   "
192983|NCT00365209|"     Chemoprevention is the use of certain substances to keep cancer from forming, growing, or     coming back. Curcumin is a compound found in plants that may prevent colon cancer from     forming. This phase II trial is studying how well curcumin works in preventing colon cancer     in smokers with aberrant crypt foci.   "
192984|NCT00365222|"     A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed     glioblastoma in elderly patients (defined as greater than or equal to 70 years old).     Following surgical resection, and confirmation of glioblastoma, patients will proceed to     primary chemotherapy with temozolomide (temodar). Temodar is given for 42 consecutive days on     and 14 days off occurring every 56 days.      Procedures prior to initial study treatment (<14 Days) are: Neurological/Oncological History,     Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality     Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast.      The same procedures are repeated on Day 1 of each treatment cycle with the addition of an     adverse event assessment. And the off study procedures for patients are performance status,     Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast.      Patients may continue with each temodar daily dose therapy if clinical and     neuroradiographical exams are stable or improving.   "
192987|NCT00365261|"     To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and     who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:        -  improve sleep thereby decreasing need for opiates via PCA        -  improve sleep thereby decreasing pain by self report        -  improve sleep thereby decreasing fatigue by self report   "
192988|NCT00365274|"     This phase II trial is studying how well giving SGN-30 together with combination chemotherapy     works in treating patients with newly diagnosed anaplastic large cell lymphoma. Monoclonal     antibodies, such as SGN-30, can block cancer growth in different ways. Some block the ability     of cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Giving SGN-30 together with combination chemotherapy may kill more cancer cells   "
192989|NCT00365287|"     RATIONALE: Giving low doses of chemotherapy and radiation therapy before a donor umbilical     cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the     patient's immune system from rejecting the donor's stem cells when they do not exactly match     the patient's blood. The donated stem cells may replace the patient's immune system and help     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after     transplant may stop this from happening.      PURPOSE: This phase I/II trial is studying the side effects of giving combination     chemotherapy together with total-body irradiation before donor umbilical cord blood     transplant and to see how well they work in treating patients with advanced hematologic     cancer, metastatic breast cancer, or kidney cancer.   "
192990|NCT00365300|"     To assess the efficacy of pantoprazole for the treatment of infants with symptomatic     Gastroesophageal Reflux Disease (GERD).   "
192991|NCT00365313|"     The purpose of this study is to compare the effect of Esomeparzole with Placebo in the     Prevention of Recurrent Ulcer Bleeding in Patients Receiving a COX-2 Inhibitor   "
192992|NCT00365326|"     This phase I clinical trial will evaluate the safety and efficacy of intra-coronary injection     of AC133 selected autologous marrow-derived stem cells in patients with chronic coronary     artery occlusion. A clinical study to determine the therapeutic potential of marrow-derived     stem cells as an adjunct therapy to current standard therapies for CAD is warranted. The     current initiative is to investigate a model of chronic myocardial ischemia and (1) to     determine whether intra-coronary injection of selected autologous marrow-derived AC133 stem     cells is reasonably safe for use in humans and (2) if this treatment shows any improvement in     coronary perfusion, as assessed using non-invasive imaging. This study is structured to     evaluate the feasibility and safety of autologous AC133+ bone marrow-derived stem cell via     intra-coronary injection into documented ischemic but viable myocardial zones via established     collateral vessels. The epicardial vessel that normally supplies the ischemic zone must be     100% chronically occluded and considered non-revascularizable by percutaneous means.   "
192993|NCT00365339|"     The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir,     identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with     famotidine results in atazanavir exposures similar to those when     atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy     subjects.   "
192994|NCT00365352|"     The primary objective of this trial is to assess the efficacy of XP13512 taken once daily     compared to placebo for the treatment of patients suffering from Restless Legs Syndrome     (RLS).   "
192995|NCT00365365|"     This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study     designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab     administered with three different docetaxel-based combination regimens for the adjuvant     treatment of participants with node positive or high-risk node negative breast cancer.   "
192996|NCT00365378|"     Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy,     immunogenicity, and safety.   "
192997|NCT00365391|"     This phase II trial is studying how well giving bevacizumab together with erlotinib works in     treating patients with advanced liver cancer. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Bevacizumab and erlotinib may also stop the growth of tumor cells by blocking blood     flow to the tumor. Giving bevacizumab together with erlotinib may kill more tumor cells   "
192998|NCT00365404|"     The purpose of the study was to implement well-developed guidelines for arthritis management     beyond acute medical management to independent community living by modifying existing weight     management and physical activity promotion programs for people with disabling arthritis.      Our hypotheses were:        1. Existing individual, health care system, and community strategies to promote physical          activity and weight management can effectively be modified and expanded to include those          with debilitating joint diseases.        2. People with inflammatory joint disease can have healthy physical activity levels and          weight at home and in the community.        3. The effect of these interventions will be higher quality of life, lower depression          rates, modest pain levels, and functional independence.   "
192999|NCT00365417|"     Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation     in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy drugs     kill cancer cells more directly. This study will evaluate:        -  How bevacizumab, given with chemotherapy before surgery, and then bevacizumab given          alone after surgery, will affect locally advanced breast tumors        -  Side effects from adding bevacizumab to chemotherapy        -  Whether adding bevacizumab to chemotherapy for breast cancer will affect the heart        -  If receiving bevacizumab will have any effect on how patients recover from surgery        -  Side effects of the combinations of drugs used in this study   "
193000|NCT00365430|"     The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program     for the prevention of three frequently occuring adverse events: pressure ulcers, urinary     tract infections and falls.   "
193001|NCT00365443|"     This study is to evaluate an investigational vaccine with the following objectives: (1) To     demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers,     external genital lesions, and persistent infection caused by the HPV types in the study     vaccine, (2) To demonstrate that the vaccine is well-tolerated in women, (3) To evaluate     vaccine immune responses in women.      This is an early phase trial and some specific protocol information is proprietary and not     publicly available at this time. (Full information is available to trial participants).   "
193002|NCT00365456|"     The objective is to show superior efficacy of PTH (1-84) over risedronate in treating     osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12     months followed by 12 months treatment with risedronate.   "
193003|NCT00365469|"     The investigators had conducted a double-blind, randomized placebo-controlled clinical trial     studying the effects of 6 months probiotics supplementation from birth on allergic disease     and sensitization up to 2 years of age. This follow-up study will extend a further 3 years to     5 years of age for assessing the longer term beneficial effects of this form of probiotics     intervention on the incidence of allergic disease and sensitization at 5 years of age.   "
193004|NCT00365482|"     The purpose of this study is to find out how often major mood swings occur in patients     treated in a specialty epilepsy center.   "
193005|NCT00365495|"     Physical activity as treatment for patients with type 2 diabetes (T2D). Treatment of T2D is     often done by medication, changing the diet and increased physical activity. It is well     established that physical training has a positive effect on the pathology of T2D such as     increased insulin sensitivity and reduced fasting plasma glucose (7) and blood lipids (15).     It is also well known that in healthy subjects endurance training increases mitochondrial     density, lipid oxidation during submaximal exercise, and results in a number of qualitative     changes in the control of OXPHOS (24). However, the effect of physical training on the     mitochondrial function in skeletal muscle of patients with T2D has not been investigated.      The purpose of this project is to investigate the effect of physical training on the     mitochondrial respiratory function in muscles of patients with T2D. Skeletal muscle biopsies     will be taken before and after 10 weeks of physical training in patients with T2D and matched     control subjects. Mitochondria will be isolated from the muscle biopsies, and respiratory     function, free radical production and UCP3 will be determined. Furthermore, measures of     maximal oxygen consumption (VO2max), heart rate and capillary lactate concentrations and     carbohydrate and lipid oxidation will be determined partly to verify an increased aerobic     capacity and partly to investigate the changes in these factors in T2D patients.   "
193006|NCT00365508|"     RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may     help smokers quit smoking. It is not yet known whether counseling and the nicotine lozenge is     more effective than counseling and the nicotine patch in helping adult smokers quit smoking.      PURPOSE: This randomized phase III trial is studying counseling and the nicotine lozenge to     see how well they work compared to counseling and the nicotine patch in helping smokers quit     smoking.   "
193007|NCT00365521|"     To evaluate a possible prophylactic efficacy of photodynamic therapy on the incidence of     non-melanoma skin cancer, actinic keratoses, warts and keratoses in recently organ     transplanted recipients.   "
193008|NCT00365534|"     The aim of this study is to compare the mechanism of loop formation and acceptance of CAC and     regular colonoscopy by MEI.   "
193009|NCT00365547|"     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as Avastin (bevacizumab), can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Giving topotecan together with     bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving topotecan together with bevacizumab     works in treating patients with stage IIIB or stage IV non-small cell lung cancer that did     not respond to previous systemic chemotherapy.   "
193010|NCT00365560|"     The primary objective of this study is to examine efficacy and safety of tiotropium compared     to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification   "
193011|NCT00365573|"     The purpose of this study is to evaluate the blood supply to patients that are suffering from     fracture in the tibia by UltraSound Doppler.   "
193012|NCT00365586|"     The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain     associated with Osteoarthritis Flare of the Knee.   "
193013|NCT00365599|"     Phase II trial to explore the efficacy of vorinostat and tamoxifen combined.   "
193014|NCT00372203|"     Proper staging of Lung cancer is of paramount concern when determining a treatment regime.     Currently the assessment of surgical candidacy is performed with the staging process, mainly     the mediastinoscopy. A mediastinoscopy has the ability to access samples of the paratracheal     lymph node stations (Levels 2R, 2L, 3, 4R, 4L), as well as the anterior subcarinal lymph node     station (Level 7). In comparison, the EBUS-TBNA technique is a real-time procedure that has     the potential to access the same paratracheal and subcarinal lymph node stations associated     with the mediastinoscopy, but also extending out to the hilar lymph nodes (Levels 10 and 11).     Because of the possibility of extended sampling range and a reduction in procedural     invasiveness, EBUS-TBNA may represent a more efficient patient centered alternative to     mediastinoscopy in the staging of lung cancer patients. Additionally, patients who are have     lymph nodes in the N2 region frequently undergo chemotherapy and/or radiotherapy prior to     surgery. Assessment of the lymph nodes after chemo/radiation is done using CT scans, as     re-mediastinoscopy is a technically difficult procedure. These patients may benefit from     EBUS-TBNA.   "
193039|NCT00372528|"     The main purpose of this trial is to allow continued access to pregabalin to Canadian     subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114     and 1008-164 and to continue to study the long term safety of pregabalin administered as     adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with     refractory partial seizures.   "
193708|NCT00380497|"     The purpose of this trial is to compare patient's satisfaction from Pico-Salax with the     standard of care, Poly-Ethylene Glycol and electrolyte solution, for bowel cleanout before     colonoscopy in children, and to compare effectiveness.   "
193015|NCT00372216|"     Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary     arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted     myocardium, which can be achieved by either thrombolytic therapy or primary PCI.      Primary PCI is facilitated if the flow in the target vessel is restored prior to the     intervention. In addition the results of recent trials hint that clinical outcome is improved     by a patent infarct-vessel before primary PCI. The CIPAMI-study analyses the effect of an     early administration of Clopidogrel on the flow-rates in subjects who suffered an acute     myocardial infarction. For this purpose they are divided into two groups, both receiving     standard baseline treatment. The subjects of one group additionally receive 600mg of     Clopidogrel, as early as possible, while the subjects in the second group receive standard     therapy. In the second group Clopidogrel is not allowed before initial angiography.      In both groups the flow-rates before and after PCI are analysed and compared in order to     evaluate the efficacy, feasibility, and safety of the administration of a high loading dose     Clopidogrel in the very early phase of STEMI in the prehospital setting.   "
193016|NCT00372229|"     This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily)     prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active     CMV infection, in CMV positive renal transplant recipients. The influence of the two     prevention concepts on the occurrence of direct and indirect effects of active CMV infections     will be compared. The anticipated time on study treatment is 3 months-1 year, and the target     sample size is 100-500 individuals.   "
193017|NCT00372242|"     The Bangladesh Integrated Nutrition Project (BINP) of the Government of Bangladesh has     started showing reduction in malnutrition of women and children under two years of age in     last 3 years of it’s activities. That was a demonstration study to test the efficacy of the     approach on a relatively small number of children with intensive intervention. A study will     be therefore conducted in 4 division of BINP thanas of Bangladesh over an 18-month period.     Moderately malnourished children will be in management intervention and mildly malnourished     and well-nourished infants will be in preventive intervention group. For management     intervention, a total of 750 moderately malnourished will be randomized to receive either     intensive nutrition education or less intensive education. For preventive purpose, 380 mildly     malnourished children of 6 months to 2 years of age and 240 well nourished infants of 6 to 9     months of age will receive either less intensive education or no education. Infants between 6     to 9 month ages will be brought under less INE to ensure their complementary feeding     practice. Care givers of one group of mildly malnourished children and one group of 6-9 month     old infants will not receive any education to serve as controls. Focus group discussion will     be held before the educational intervention to identify the perception of the mother, her     husband and female decision maker of her family on child nutrition, caring practice and     common practice of health care. BCC materials will be developed after FGD and that will be     used during nutrition education. Mothers of the first intervention group will receive     intensive nutrition education for child feeding twice weekly for first three months, which     will be then reinforced once in a week for the last three months of intervention. The less     intensive intervention group will receive nutrition education twice a week for the first     month then once a week for two months and then twice monthly for the last three months of     intervention. INE will be given for a total of 6 months. An observation will be done to     identify for sustainability effect for an additional period of 6 months. Their weight and     length gain will be recorded. It is expected that the results of the study will help define     the effectiveness of our nutrition education package to prevent and reduce moderate     malnutrition existing in large proportion of children in setting with different geographical,     and cultural and feeding practices.   "
193018|NCT00372255|"     The study will evaluate the immune response and the tolerability of the influenza vaccine     administered in children aged 6-13 years old.   "
193019|NCT00372268|"     During laparoscopy, administration of cold and dry carbon dioxide (CO2) leads to hypothermia.     Different types of gas conditioning have been studied in order to prevent this specific     hypothermia. Intra-abdominal administration of local anesthetics has also been studied in     order to prevent post-operative pain. In both cases, some results have been described.      The investigators propose to evaluate in a prospective, randomized, double blind trial, the     impact of 4 different types of conditioning of insufflated gas during laparoscopy for womb     surgery on hypothermia prevention and post-operative pain. These 4 types of gas conditioning     are:        -  CO2 wet and cold with nebulized Nacl and direct intra-abdominal administration of Nacl        -  CO2 wet and cold with nebulized ropivacaïne 0.75% and direct intra-abdominal          administration of Nacl        -  CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 0.2%        -  CO2 dry and cold with direct intra-abdominal administration of Nacl      The investigators use a new device (Aeroneb® Pro [Aerogen® Company]) which can wet (by     nebulization) the insufflated gas and therefore permits intraperitoneal medicament     administration (local anesthetics).   "
193020|NCT00372281|"     USPIO contrast enhancement results from intracellular trapping of the iron particles in     reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages     are present in spine infectious diseases but are absent in spine degenerative diseases. The     aim of this work is to compare the enhancement induced by CLIAVIST in both diseases. The     absence of macrophages in degenerative lesions should help to differentiate them from     infectious lesions, who should present contrast enhancement in relation to the presence of     macrophages.   "
193021|NCT00372294|"     Toxoplasmosis, an intra cellular parasite, is a very important cause of chorioretinitis. The     goal of treatment is arresting multiplication of the parasite in its inflammatory active     phase. In this study the investigators try to compare the efficacy of the classic regimen     (Pyrimethamine-Sulfadiazine + Prednisolon) with intravitreal Clindamycin & Dexamethasone.   "
193022|NCT00372307|"     Patients with vitiligo vulgaris are treated with Pimecrolimus twice a day during 6 months.     After a baseline visit, patient returns for a control visit after 3 and 6 months of     treatment. One reference lesion is clinically evaluated with pictures.   "
193051|NCT00372723|"     To determine whether treatment of patients who have toxic epidermal necrolysis with a drug     called remicaide increases the number of patients who are alive 30 days laters.   "
193052|NCT00372736|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug.      PURPOSE: This phase I trial is studying the side effects and best dose of AEG35156 when given     together with docetaxel in treating patients with locally advanced, metastatic, or recurrent     solid tumors.   "
193053|NCT00372749|"     To evaluate the effect of the threat of an aversive reaction on the response during alcohol     cue exposure in alcohol dependent patients : (1) the subjective response (craving) and (2)     the physiological response (heart rate and blood pressure).   "
193180|NCT00374426|"     To study the effectiveness of sertraline (Zoloft) in treating depression in adults with     diabetes. The study will also determine whether depressed diabetic patients who have     successfully responded to sertraline (Zoloft) are more likely to have depression recur if the     sertraline (Zoloft) is discontinued.   "
193023|NCT00372320|"     This study will examine whether the experimental drug AdhAQP1 can increase salivary flow in     patients whose parotid glands have been exposed to therapeutic radiation for treatment of     head and neck cancer. Radiation may damage the parotid glands (salivary glands located under     the skin in front of the ear), leading to dry mouth, infections, excessive tooth decay, mouth     sores, difficulty swallowing and pain. AdhAQP1 contains the human aquaporin-1 gene, which     codes for a protein that works to transport water across cells, and a virus that normally can     cause colds in humans, but is modified to render it ineffective. In animal experiments,     AdhAQP1 has increased saliva production for a short time.      Patients between 18 years of age or older who received radiation treatment for head and neck     cancer at least 5 years before enrolling in this study, who have no evidence of recurrent     tumor, who have dry mouth and who secrete abnormally low levels of saliva from the parotid     glands may be eligible for this study. Candidates are screened with a medical history,     physical examination, blood, urine and saliva tests, electrocardiogram (EKG), chest x-ray,     MRI exam, gallium scan (a nuclear medicine test to look for inflammation in the salivary     glands), technetium pertechnetate scan (a nuclear medicine test to examine salivary gland     function), parotid sialogram (x-ray of parotid gland), PET and CT scans to look for signs of     tumor and a skin biopsy to collect skin cells for use in immunological tests.      Participants have a salt and sugar solution infused through a catheter (plastic tube) into     both parotid glands. After 10 minutes, the solution drains into the mouth and is swallowed.     Saliva is collected from the parotid glands at 6 and 24 hours after administration of the     salt and sugar solution. Ten to 14 days later, patients are admitted to the NIH Clinical     Center for up to 4 days for the following tests and procedures:        -  On the first day, administration, through a catheter, of the study drug AdhAQP1 into one          parotid gland.        -  Monitoring over the next 3 days for changes in patients' ability to produce saliva. This          includes medical examinations and several blood, urine and saliva collections.        -  Technetium scan on day 2.        -  Gallium scan on day 2.      Patients return to NIH for follow-up visits at 1, 2, 4, and 6 weeks after the AdhAQP1     infusion and then 3, 4, 5, 6 and 12 months for a medical examination and blood, urine and     saliva collections. Gallium, technetium and MRI scans are repeated at several of the     follow-up visits, and sialograms are done at 6 and 12 months. Chest x-ray and EKG are     repeated at 4 and 6 months.   "
193024|NCT00372333|"     The main aim of the study is to evaluate safety, efficacy, compliance, and usage of     epicutaneously applied IDEA-033 in joint / musculoskeletal pain or soft tissue inflammation.   "
193025|NCT00372346|"     Experimental data suggest that transplantation of endothelial progenitor cells (EPCs)     attenuates monocrotaline-induced pulmonary hypertension in rats and dogs. In addition,     clinical studies suggest that autogolous progenitor cells transplantation is feasible and     safe in patients with ischemic disease. This study will investigate the feasibility, safety,     and initial clinical outcome of intravenous infusion of autologous EPCs in patients with     idiopathic pulmonary arterial hypertension.   "
193026|NCT00372359|"     The purpose of this study is to find out whether prolonged treatment with methylphenidate has     any adverse effect on cardiac functions and measurements.   "
193027|NCT00372372|"     The efficacy of risedronate in prevention of bone loss in patients receiving high dose     corticosteroid treatment   "
193028|NCT00372385|"     Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon     Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C     virus (HCV) ribonucleic acid (RNA) levels   "
193029|NCT00372398|"     The purpose of this trial is to study the proportion of scleroderma patients who suffer from     asymptomatic coronary atherosclerosis compared to healthy controls.   "
193030|NCT00372411|"     This study will compare robotic training with usual care and intensive comparison therapy to     attempt to improve upper extremity function.   "
193031|NCT00372424|"     This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity     of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or     metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment     in the advanced disease setting.   "
193032|NCT00372437|"     Inthis study, MGCD0103, a new anticancer drug under investigation, is given three times     weekly in combination with gemcitabine to patients with solid tumours.   "
193033|NCT00372450|"     RATIONALE: Placing a stent in the esophagus may lessen swallowing difficulties and improve     quality of life in patients with malignant dysphagia caused by esophageal cancer or     gastroesophageal junction cancer.      PURPOSE: This randomized clinical trial is studying self-expanding plastic stents to see how     well they work compared with self-expanding metal stents in treating patients with malignant     dysphagia caused by esophageal cancer or gastroesophageal junction cancer.   "
193034|NCT00372463|"     Diabetes is a growing health problem causing personal suffering, comorbid conditions,     premature death, and high costs to the individual, the health care system and society. Many     of these problems can be prevented or delayed by controlling the disease. This in turn     requires daily self-management by patients.      We will evaluate an Internet based small group Diabetes Self-Management Program. This program     will be adapted from the Chronic Disease Self-Management Program Online, already developed     and currently being evaluated by the investigators. Participants with type 2 diabetes will be     randomized to participate in the Internet Program or serve as controls continuing with usual     care. Treatment subjects will participate in a structured 6 week interactive web-based online     class with 20-24 other participants and 2 trained peer moderators.      If successful, this project will result in a new and effective means of reaching the CDC     objective and more importantly in improving the quality of life and health status of people     with diabetes while reducing health care utilization and thus costs.   "
193035|NCT00372476|"     This study is designed to investigate the safety and efficacy of the combination of imatinib     and vinorelbine in patients with advanced, anthracycline resistant breast cancer   "
193036|NCT00372489|"     The purpose of this study was to evaluate the long term safety and tolerability of     peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease     (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.   "
193037|NCT00372502|"     The purpose of this study is to determine if there is equivalence between two different     methods of treating patients with severe bloodstream infection called sepsis. We will     randomly assign patients to one of two treatment methods. One of the treatment methods is the     current standard of care and uses an infrared sensor on the end of a catheter to determine     the adequacy of treatment. The second treatment method is identical to the first but instead     of the infrared sensor a blood test that is performed as a part of standard care (with blood     drawn from the catheter) will be used to determine the adequacy of treatment. This study will     attempt to determine an easier method of guiding treatment.   "
193038|NCT00372515|"     The primary purposes of this study are to find out if using high doses of the drug Gefitinib     (Iressa) as a way to treat patients with non-small cell lung cancer that has spread to the     covering of the brain and/or spinal cord (meninges) results in any bad side effects; and to     determine the highest dose that can be given to patients in this setting.   "
193040|NCT00372580|"     Psoriasis is a chronic inflammatory skin disease characterized by the formation of scaly and     erythematous plaques. A Th1-cell mediated process is believed to be involved in the     pathogenesis of psoriasis. It is mainly because of the detected Th1 cytokine profile in the     sera and tissue. Epidemiologic studies also showed a significantly decreased incidence of     atopic dermatitis. According to the Th1 and Th2 dogma, psoriasis and atopic dermatitis are     two mutually exclusive dermatoses. However, the simple dichotomy of Th1 and Th2 in the     pathogenesis of psoriasis and atopic dermatitis may be overly simplistic.1. Recent genetic     studies suggest striking overlapping genetic loci for both psoriasis and atopic dermatitis.     In fact, atopic dermatitis and psoriasis shared more genetic similarity than atopic     dermatitis and asthma. 2. It is indeed, difficult to find patients with both typical atopic     dermatitis and psoriasis. However, asthma is not so rarely encountered in psoriasis. And     asthma is one of the hallmark in the diagnosis of atopic dermatitis. 3. The cytokine profile     in long-standing atopic dermatitis shifted to a Th1 profile. A mixed Th1 and Th2 chemokine     profiles are present in atopic dermatitis. Scratch can result in a Th1 infiltrate in animal     model. 4. Patients with erythrodermic psoriasis has a higher percentage of elevated IgE     levels. And tissue or peripheral eosinophilia might be present. 5. Eczema is a known     precipitating factor of psoriasis. Areas of atopic dermatitis in childhood may serve as     koebernizing loci for the future development of psoriasis. And in adulthood, since the main     pathologic event of asthma is in the aerorespiratory tract, the presence of Th2 cytokine     profile does not seemingly affect the build up of a Th1 profile in the skin of psoriasis.   "
193041|NCT00372593|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as gemtuzumab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab     may kill more cancer cells. It is not yet known whether combination chemotherapy is more     effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid     leukemia.      PURPOSE: This randomized phase III trial is studying combination chemotherapy and gemtuzumab     to see how well they work compared with combination chemotherapy alone in treating young     patients with newly diagnosed acute myeloid leukemia.   "
193042|NCT00372606|"     The purpose of this study is to conduct a randomized trial to rigorously test the efficacy of     the MiDieta eHealth portal for weight loss among overweight, though otherwise healthy,     members of the Hispanic community, many of whom may be members of collaborating managed care     organizations.   "
193043|NCT00372619|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when     given together with cytarabine and to see how well they work in treating young patients with     refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I     closed to enrollment as of 09/16/09)   "
193044|NCT00372632|"     The present study will address the question whether the use of IPT using SP in pregnancy is     efficacious in Rwanda, where it is going to be used for the first time, in areas with high     levels of SP resistance. While the implementation of the new policy will take place in areas     at low SP resistance level, where we expect pregnant women and newborns to benefit from it,     it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high     SP drug resistance and at what level of SP resistance this strategy is still efficacious. As     bed nets are a part of the actual control strategy of malaria in pregnancy all women will     receive a bed net at enrolment   "
193045|NCT00372645|"     The aim of this study is to determine the best source of folate to raise the folate status of     a general population over a 16 week intervention period.   "
193046|NCT00372658|"     The purpose of this study is to compare the efficacy of 1% lidocaine intracervical block to     placebo for pain control during the performance of a hysterosalpingogram (HSG). We     hypothesized that an intracervical block would decrease pain during a hysterosalpingogram.   "
193047|NCT00372671|"     The purpose of this study is to determine whether a pre-discharge videotape introducing the     concept and benefit of a Cardiac Rehabiliation & Secondary Prevention (CRSP) program will     increase intent to participate in a CRSP program in post myocardial infarction, unstable     angina, coronary artery bypass surgery, or coronary angioplasty patients.   "
193048|NCT00372684|"     Plasmodium falciparum malaria remains a major public health problem in endemic areas, with     approximately 2 million deaths each year, especially in tropical African countries.      In non-endemic industrialized areas, imported malaria is generally diagnosed in travelers, as     well as immigrants from endemic countries. Such imported cases have increased worldwide, with     approximately 7000 cases each year in France. Among these cases, 300 are severe requiring     hospitalization in the intensive care unit (ICU) with an overall mortality rate of 10%,     despite available effective care.      Many studies have been performed to evaluate clinical and physiopathological aspects of     severe malaria in endemic areas but few data are available for imported malaria. Therefore,     determinants of severe imported malaria are not well known. The majority of patients     hospitalized in the ICU for severe malaria are white caucasians as well as those patients who     die.      The present study has two main objectives:      (i) to describe the clinical spectrum of severe imported malaria and to assess outcome     (mortality and neurological sequelae), and the biological interactions between host and the     parasite,      (ii) to evaluate the role of gene polymorphisms, of parasitic factors in the occurrence of     severe malaria with a case control study comparing severe and non-severe malaria in patients     matched according to ethnic patterns. The intensity of the inflammatory response will also be     studied in the two groups of patients.   "
193049|NCT00372697|"     This study evaluated the safety and efficacy of an increased frequency of octreotide acetate     injections or an increase in dose in partially responsive acromegalic patients with     persistently uncontrolled disease.   "
193050|NCT00372710|"     Zoledronic acid selectively binds to bone and protects it from being metastasized by tumor     cells. This study evaluates the safety and efficacy of zoledronic acid when added to standard     therapies in breast cancer patients with metastatic bone lesions.   "
193054|NCT00372762|"     Patients with NYHA FC II-III heart failure will be randomized in a cross-over fashion to 8     weeks of bumetanide versus furosemide therapy (equipotent dose), to test whether bumetanide     therapy has a superior effect on insulin resistance compared to furosemide. Patients will be     subject to a frequently sampled intravenous glucose tolerance test (FSIGT) with minimal model     (MINMOD) analysis to assess insulin resistance and to a 6-minute walk test (6MWT) to assess     functional capacity; patient recruitment and retention success, as well as medication     adherence, will also be assessed.   "
193055|NCT00372775|"     This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with     non-small cell lung cancer with brain metastases.   "
193056|NCT00372788|"     The purpose of this study is to assess the effect and safety of AZD6244(ARRY-142886)versus     pemetrexed in the second or third line treatment of advanced Non-Small Cell Lung Cancer.     Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from     the US will be treated with either AZD6244 or pemetrexed. Treatment will be continued for as     long as patients receive clinical benefit.   "
193057|NCT00372801|"     To demonstrate that new drugs work, many complex multidose studies are often required. The     intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to     validate a simpler single dose model for future assessment of new pain drugs.   "
193058|NCT00372814|"     The study is a randomized clinical trial testing the effectiveness of Multisystemic Therapy     (MST) for improving the treatment adherence, metabolic control and quality of life of urban     adolescents with poorly controlled insulin dependent diabetes.   "
193059|NCT00372827|"     The purpose of the study is to compare the efficacy and safety of Timolol 0.5% solution to     Brinzolamide 1% each given twice daily when added to Travoprost 0.004% given each evening.   "
193060|NCT00372840|"     RATIONALE: Printed educational materials, such as the Facing Forward Series: Life After     Cancer Treatment manual, may help make the transition from cancer patient to cancer survivor     easier in patients who are finishing treatment for cancer. It is not yet known if the Facing     Forward Series: Life After Cancer Treatment manual and The Cancer Information Service,     Questions and Answers fact sheet is more effective than the The Cancer Information Service,     Questions and Answers fact sheet alone in helping to make life after cancer treatment easier     and to improve quality of life in patients with breast cancer, colorectal cancer, prostate     cancer, or chest cancer.      PURPOSE: This randomized clinical trial is studying how well printed education materials work     in assisting patients who are finishing treatment for stage I, stage II, or stage IIIA breast     cancer, colorectal cancer, prostate cancer, or chest cancer to make the transition from     cancer patient to cancer survivor easier.   "
193061|NCT00372853|"     This study will determine the highest tolerable dose of CP-675,206 when given in combination     with SU011248.   "
193062|NCT00372879|"     Muscular cramps are a common and uncomfortable symptom of amyotrophic lateral sclerosis     (ALS). This clinical trial will compare the response of high dose vitamin E supplementation     to placebo for treatment of muscular cramps in patients with ALS. We hypothesize that vitamin     E will be more effective than placebo in treating cramps.   "
193063|NCT00372892|"     The purpose of this study is to assess the feasibility of a randomized, double blind, placebo     controlled trial of add-on rituximab for non-splenectomized adults with acute immune     thrombocytopenic purpura (ITP).   "
193064|NCT00372905|"     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal     antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry     cancer-killing substances to them without harming normal cells. Giving bortezomib together     with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.      This phase I/II trial is studying the side effects and best dose of bortezomib when given     together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work     in treating patients with relapsed or refractory follicular non-Hodgkin's lymphoma.   "
193065|NCT00372918|"     The purpose of this study is to determine the prevalence of esophageal pathology in patients     with voice disorders. In addition, , the intra- and interdisciplinary variability regarding     the identification of esophageal pathology will be analyzed in this study.   "
193066|NCT00372931|"     The purpose of this study is to determine whether AL-37807 is safe and effective in treating     patients with open-angle glaucoma or ocular hypertension   "
193067|NCT00372944|"     The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus     capecitabine in patients with advanced or metastatic pancreatic cancer who have failed     first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients     in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine.     Treatment will be continued for as long as the patients receive clinical benefit. The status     of all patients will be checked (whether they are still taking treatment or not)     approximately 3 months after the last patient has entered the study.   "
193068|NCT00372957|"     To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of     GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes     mellitus (T2DM) patients.   "
193069|NCT00372970|"     It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a     contributing feature. Botox relaxes the pylorus so that food can empty the stomach more     rapidly. Lesser quality studies have shown that this treatment works in about 40% of     patients, and relieves symptoms for up to 3 months. This study compares this treatment to     placebo (saline) injection. After a 1 month period patients may elect to receive open label     botox who have not received relief from their first injection. Patients symptoms and gastric     emptying are followed for 1 year.   "
193083|NCT00373152|"     RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor     cells. Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning     how well radiofrequency ablation works to kill breast cancer cells and help doctors predict     whether breast cancer cells remain after treatment.      PURPOSE: This phase II trial is studying how well MRI works in predicting tumor response     after radiofrequency ablation in women with invasive breast cancer.   "
193070|NCT00372983|"     The purpose of this research trial is to find out whether NOV-205 is well tolerated compared     to placebo (salt water) in people with hepatitis C. In addition, this trial will test how     NOV-205 is absorbed by your body after single and multiple doses of the trial drug, and it     will look for early signs of therapeutic activity (decreases in indicators in the blood for     the hepatitis C virus and for liver damage). This is known as pharmacokinetics (PK). NOV-205     is an experimental drug. Experimental means that the trial drug is currently being tested     and is not approved for sale in the United States by the Food and Drug Administration (FDA).     However, NOV-205 has been approved by the Russian Federation for treatment of liver diseases     including hepatitis C. Clinical studies in that country showed that subjects treated with     NOV-205 alone had decreased indicators in the blood for the hepatitis C virus and for liver     damage.   "
193071|NCT00372996|"     To test the efficacy of CP-751,871 combined with exemestane in the treatment of     postmenopausal patients with hormone positive advanced breast cancer   "
193072|NCT00373009|"     We are studying whether specific back exercise and education programs effectively limit the     development of chronic low back pain in Soldiers in the United States Army. These programs     represent the current best evidence for prevention of low back pain from an exercise and     education perspective. This innovative study will investigate whether a combination of     evidence-based exercise and education programs effectively decreases the impact of chronic     low back pain, when compared to individual evidence-based exercise and education programs, or     a traditionally implemented exercise program.   "
193073|NCT00373022|"     RATIONALE: Physical activity may prevent or lessen depression and anxiety and improve quality     of life and immune function in patients with colorectal cancer.      PURPOSE: This randomized clinical trial is studying how well physical activity helps patients     with stage II or stage III colorectal cancer recover from cancer.   "
193074|NCT00373035|"     RATIONALE: Collecting and storing samples of blood and urine from patients with cancer to     study in the laboratory may help doctors learn more about changes that may occur in DNA and     identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking at biomarkers in patients undergoing transrectal     ultrasound prostate biopsy.   "
193075|NCT00373048|"     This is a randomized placebo controlled trial. Malaria chemoprophylaxis with mefloquine in     asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya, Zambia will     be compared to a placebo control group and followed up for 18 months.   "
193076|NCT00373061|"     The Xolair Pregnancy Registry is an observational study established by Genentech to obtain     data on pregnancy outcomes in women who are exposed to Xolair. Women exposed to at least one     dose of Xolair within 8 weeks prior to conception or at any time during their pregnancy will     be followed to completion of their pregnancies. The evaluation of infants will be conducted     at birth and at 6-month intervals until infants are 12 months old.   "
193077|NCT00373074|"     The purpose of this study is to address the question, What is the volume of blood for     injection at epidural blood patch that most effectively relieves post-dural puncture     headache?   "
193078|NCT00373087|"     Entacapone is an antiparkinsonian drug which block L-dopa metabolism, inhibiting the     C-O-methyltransferase (COMT) enzyme. There is an individual variability of the COMT activity     determined by a genetic polymorphism. The aim of this study is to investigate whether the     genetic variability influences entacapone efficacy in Parkinson's disease.   "
193079|NCT00373100|"     Pneumonia is a leading cause of morbidity and mortality in children in developing countries.     Zinc deficiency leads to impairment in tissue repair and immunodeficiency in children.At     least two randomised controlled trials have shown that zinc supplementation improves the     outcome of severe pneumonia in children (reducing duration of hospital stay and complications     related to pneumonia).      However, there are conflicting results from other randomised controlled trials about its     efficacy in children with pneumonia.The purpose of the current study is to determine the     efficacy of zinc as adjunct therapy for in severe pneumonia in children aged 6-59 months. We     hypothesize that the proportion of children who recover from severe pneumonia following zinc     adjunct therapy [(10 mg once daily for seven days) for children aged <12 months and 20 mg     daily for children aged ≥12 months]will be higher than the proportion of children who recover     from placebo therapy.   "
193080|NCT00373113|"     To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast     cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a     taxane and for whom further anthracycline therapy is not indicated   "
193081|NCT00373126|"     It has been suggested that patients with schizophrenia smoke in order to produce amelioration     of dysfunctional dopaminergic pathways allowing them to experience pleasure and satisfaction     and overcome anhedonia. No studies have assessed the effects of nicotine withdrawal on reward     responsivity in patients with schizophrenia. The investigators believe that an understanding     of this is crucial if improved treatments for nicotine dependence are to be developed for     this patient population. If this group already has deficits in reward responsivity as a     symptom of the disease then they may be particularly prone to the effects of nicotine     withdrawal on reward systems. Smoking cessation may lead to a further decrease in their     responsivity to pleasurable stimuli and worsening anhedonia. Treatments for smoking cessation     may need to ameliorate any increased deficits if they are likely to be effective in patients     with schizophrenia.   "
193082|NCT00373139|"     It is common practice in the emergency medicine department to rapidly assess pregnancy status     through the use of either urine or serum in pregnancy tests. Using whole blood instead of     urine would facilitate a much more rapid emergency department identification of pregnancy     status. No study to date has utilized whole blood for rapid detection of pregnancy status.     Set in the busy adult emergency room at Maimonides Medical Center, this study will recruit a     sample of women of reproductive age (18-55), who fit the inclusion criteria of being healthy     and in need of a pregnancy test for own purpose or diagnostic testing/treatment. Blood     samples will be taken from the participants and used in the hCG kits and the remaining blood     was sent to the chemistry laboratory to perform the reference gold standard. The reference     gold standard for a positive test is an hCG level >25mlU/ml. The research investigators and     lab will be blinded to each other's results. Kappa statistics will be done for the     measurement agreement between urine pregnancy results and whole blood pregnancy results, and     whole blood results with laboratory results.   "
193084|NCT00373165|"     Study Phase: IV      Study Type: Open-label, multicenter, randomised clinical trial with two arms stratified for     an intensified immunosuppressive regimen in patients at high risk for acute rejection.      Study Description: 148 kidney transplant recipients at risk for CMV disease were randomized     and treated with ganciclovir capsules for 3 months (Group A, prophylaxis, N=74) or received     ganciclovir IV only in case of proven CMV viral load (Group B, preemptive therapy, N=74).     Initially, a 2 months follow up was planned in this trial. However, the study group decided     to offer a longterm follow up to all patients and amended the protocol, respectively.      The aim of the study was to identify the most efficacious way to prevent renal transplant     recipients from CMV disease and to find out, if one of these two strategies may increase     graft or patient survival. Therefore, both wellknown approaches of CMV prevention were     compared in two study groups:      Prophylaxis (Group A): Oral primary prophylaxis with ganciclovir capsules was started     directly after transplantation and performed until day 90. In case of CMV infection (proven     CMV viral load) or symptomatic CMV disease, treatment with ganciclovir IV was initiated.      Preemptive Therapy (Group B): No oral primary prophylaxis was given. Treatment with     ganciclovir IV was given to patients with proven CMV viral load (CMV infection or CMV     disease) only.   "
193085|NCT00373178|"     The aim of the present study is to investigate the influence of several anti-diabetic     regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in     patients with recently diagnosed type 2 diabetes.   "
193086|NCT00373191|"     RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the     laboratory may help doctors learn more about changes that may occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This laboratory study is looking at the effects of surgery, radiation therapy,     chemotherapy, and hormone therapy on biomarkers in women with stage I, stage II, stage III     breast cancer, or ductal carcinoma in situ that can be removed by surgery.   "
193087|NCT00373204|"     The purpose of this study is to determine if the addition of motexafin gadolinium (study     drug) to standard treatment with docetaxel will improve the response rate in patients with     non-small cell lung cancer.   "
193088|NCT00373217|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed. Giving vaccine therapy and chemotherapy     after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with     paclitaxel and carboplatin works in treating patients who are undergoing surgery for stage     III or stage IV ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.   "
193089|NCT00373230|"     Obesity has reached epidemic proportions with nearly two-thirds of the US population either     overweight or obese. Thus, novel strategies that both improve weight loss maintenance and are     accessible to those most in need are the focus of this application, which will determine if a     telemedicine system can help participants, who have undergone a weight loss program based in     church and community centers, maintain their weight loss over a 1 year period. Telemedicine     will provide support through self-monitoring, education, supervised chat room, bulletin     board, and e-mail.   "
193090|NCT00373243|"     This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in     subjects with moderate hepatic impairment in comparison to matched healthy volunteers. The     hepatically impaired and healthy groups will be given a single 20 mg oral dose of GW406381.     Blood samples for PK analysis will be collected pre-dose and over the 72 hours post dosing.     Subjects will be housed from the evening before dosing until 24 hours after dosing. A     follow-up visit will be conducted between 7 to 10 days from the last dose of study drug.   "
193091|NCT00373256|"     To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to     determine which treatment works better against breast cancer   "
193092|NCT00373269|"     Between twenty and fifty percent of people who have acute stroke have hyperglycemia (high     blood sugar) with it. The purpose of this study is to examine the relationships between     diabetes mellitus, hyperglycemia,whole blood tissue factor procoagulant activity (TF-PCA) and     plasma factorVIIa (FVIIa) in ten patients with type 2 diabetes mellitus and 11 non-diabetic     patients at baseline and 6, 12, 24, and 48 hours (h) after presentation for acute stroke.   "
193093|NCT00373282|"     To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of     surgery for PVR.   "
193094|NCT00373295|"     The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's     direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.   "
193095|NCT00373308|"     This study will utilize the Expanded Prostate Cancer Index Composite questionnaire to learn     what impact the surgery has upon the participant's sense of health, sexual and urinary     quality of life.   "
193096|NCT00373334|"     The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid     Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in     infants age 30 days up to 1 year.   "
193097|NCT00373347|"     The aim of the study is to see if there any changes in the quality of life for patients that     are undergoing radical prostatectomy.   "
193098|NCT00373360|"     The purpose of this 8-week study is to compare the effects of switching from therapy with     epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing     to Remodulin will have on patient satisfaction with their treatment and impact on quality of     life.   "
193099|NCT00373373|"     The primary purpose of the study is to determine, whether the addition of Sorafenib to     standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results     (event free survival).   "
193116|NCT00373594|"     Chronic cold agglutinin disease (CAD) is a type of autoimmune hemolytic anemia (anemia due to     destruction of red blood cells by abnormal antibodies). Almost all patients also suffer from     cold-induced disturbances of blood circulation. The purpose of this study is to assess the     efficacy and safety of combination therapy with rituximab (an antibody against B lymphocytes)     and fludarabine (a cytotoxic drug) for CAD. Another aim is to try to assess whether these     agents in combination are better than single agent therapy with rituximab.   "
193100|NCT00373386|"     Objective: This study is designed to determine whether growth hormone treatment in children 8     to 18 years of age alters function of the lining of the arteries. This may play a role in     increasing or decreasing the risk of heart disease.      Methods. Twenty children, for whom growth hormone therapy will be otherwise provided, will be     studied before and 3 months after starting growth hormone. Subjects can be on other hormonal     replacements but no other medications.      Each study will be done in the fasting state. The blood vessel function will be determined by     measuring the change in forearm blood flow before and after blocking flow to the arm for 5     minutes. Blood will be drawn after the test to measure glucose, insulin and fats.   "
193101|NCT00373399|"     The purpose of this study is to investigate the effects of smoked marijuana on both risk     taking and decision making tasks.   "
193102|NCT00373412|"     Objectives of this trial are to:      Evaluate the kinetics and magnitude of the CMV-specific immune response post-Towne challenge     (3000 pfu) in healthy CMV-seronegative volunteers who receive VCL CT02 administered (1 mg     weekly x 3) 3 months previously compared to randomized controls who do not receive VCL CT02     as measured by:        1. antibody titers for gB;        2. T-cell IFN-g ELISPOT;        3. T-cell proliferation assays for IE1, pp65, and/or gB; and        4. cytokine and phenotypic flow cytometry responses to pp65, IE1, and/or gB.      Evaluate the safety safety of Towne challenge in healthy CMV-seronegative adult subjects who     have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02) administered     intramuscularly.      Our hypothesis is that the immune response to Towne vaccine 3000 pfu challenge after VLC-CT02     priming will be greater than that after Towne vaccination alone.   "
193103|NCT00373425|"     This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill     following complete surgical removal of the tumor with or without chemotherapy after surgery     in Stage IB-IIIA NSCLC patients.   "
193104|NCT00373438|"     Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung     failure due to lung underdevelopment and pulmonary hypertension. In severe cases,     extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to     enable survival of severely affected infants.      Clinical experience from prospective controlled non-randomized case series with fetoscopic     tracheal balloon occlusion has seen improved survival rates in contrast to untreated     controls.      Therefore, the purpose of this randomized clinical trial in a less severely affected subgroup     of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive     care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO     therapy.   "
193105|NCT00373451|"     The purpose of this study is to determine which of these anti-clotting medications, abciximab     plus unfractionated heparin or bivalirudin, is more effective to prevent thrombotic and     bleeding complications in patients suffering from a heart attack and undergoing coronary     intervention.   "
193106|NCT00373464|"     The aim of this trial is to compare if a single dose of oral etoricoxib 120 mg will have     equal post-operative analgesic efficacy as an optimal regiment of intravenous ketorolac 30 mg     + 30 mg during the first 18 hours (+/- 1 hour) after gynaecologic laparoscopic surgical     procedures, where the need for post-operative opioid is expected.   "
193107|NCT00373477|"     This project will enable the investigators to conduct a randomized clinical trial to     demonstrate the value of generalist care managers in the treatment of depression in Medicaid     patients seen in primary health care practices. Depressed patients will be recruited at two     primary care practices in Western North Carolina and randomly assigned to either generalist     care management or usual care. Patients in each condition will be assessed at baseline and     six months follow-up. Outcomes will include depressive symptoms, level of functioning, and     cost-effectiveness measures.   "
193108|NCT00373490|"     This is a clinical study to evaluate the safety and pharmacokinetics of an overseas     determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient     population with solid tumors.   "
193109|NCT00373503|"     The purpose of this study is to investigate the interaction between marijuana and two     potential treatment medications: lofexidine and oral THC, with the direct goal of using this     information to improve marijuana treatment outcome.   "
193110|NCT00373516|"     The purpose of this study is to evaluate the efficacy and safety of two dosing regimens of     QRX-101 ointment (75 mcg/g QD and 75mcg/g BID) in the treatment of plaque-type psoriasis when     applied topically twice daily for 8 weeks   "
193111|NCT00373529|"     Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the     treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia     (ALL) who have had at least 2 prior treatment regimens.      This study will evaluate the efficacy of clofarabine in elderly patients with acute     myelogenous leukemia (AML) who are unlikely to benefit from treatment with intensive     chemotherapy regimens (cytarabine and anthracycline based regimens) used in younger patients     with AML.   "
193112|NCT00373542|"     The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the     treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period     limb movements during sleep.   "
193113|NCT00373555|"     Sarcoidosis is a benign, inflammatory condition which will typically involve the lungs and     lymph glands in the chest. Diagnosis is often confirmed with bronchoscopic biopsy. A new     method of performing bronchoscopic biopsy of lymph glands in the chest has now been developed     which uses real-time endobronchial ultrasonography to better locate the lymph glands. While     this technique has been proven to be effective in the diagnosis and staging of lung     malignancy, its sensitivity for the diagnosis of sarcoidosis is unclear as smaller samples     are obtained compared to the standard approach. This study will aim to randomize 50 patients     with a clinical suspicion of sarcoidosis to standard biopsy vs. endobronchial ultrasound     guided biopsy of the mediastinal lymph glands in order to compare the sensitivity of these     tests for sarcoidosis.   "
193114|NCT00373568|"     Miltefosine (longer course) will be used to try to improve the cure rate of mucosal     leishmaniasis   "
193115|NCT00373581|"     The objective of this study is to determine if vigabatrin will decrease cocaine     self-administration, cardiovascular effects, subjective effects and craving compared to     placebo.   "
193178|NCT00374400|"     The purpose of the protocol is to increase the number of living donor transplants by     eliminating immune incompatibilities between donors and recipients through paired donation.   "
193117|NCT00373607|"     In Peru, Mefloquine plus Artesunate (MAS3), is the current first line treatment for P.     falciparum malaria in the Amazonian Region, and has proved its efficacy against     multi-resistant P. falciparum parasites, but several side effects have been reported.     Dihydroartemisinin-piperaquine (DHA-PPQ) is a new co-formulated and well tolerated ACT,     increasingly used in Southeast Asia where it has proved to be highly effective against     Plasmodium falciparum malaria. We tested the efficacy, safety and tolerability of DHA-PPQ in     patients with uncomplicated P. falciparum malaria. A RCT to evaluate DHA-PPQ was carried out,     between 2003 and 2005. Patients with uncomplicated P. falciparum malaria were randomly     allocated to receive either DHA-PPQ or MAS3 with a 63-day follow-up period. Five hundred     twenty two patients were included in the analysis, 262 were allocated to receive DHA-PPQ, and     260 to receive MAS3. The two groups were comparable at baseline in demographic and clinical     characteristics. The mean time for parasite clearance into the DHA-PPQ group was 32.0 hours     and 35.5 hours in the MAS3 group. Twenty-four hours after the first dose, the proportions of     patients whose cleared parasitaemia were 67.2% in the DHA-PPQ group, and 58.1% in the MAS3     group (RR 1.25, [95% CI 1.03−1.52], p = 0.017). All patients were able to clear parasites     within 72 hours after the first dose. The mean time for fever clearance was 28.0 and 29.5     hours in DHA-PPQ and MAS3 group respectively. (P= 0.69). Twenty-four hours after the first     dose, 85.5% and 83.1% of patients cleared fever in the DHA-PPQ and MAS3 group respectively     (p>0.05). The Adequate Clinical and Parasitological Response (ACPR), PCR adjusted, were 97.7%     and 99,2% for the DHA-PPQ and MAS3 group respectively, (RR 0.99, 95% CI [0.86−1.13], P =     0.88). No Early Treatments Failures were reported in any group. In the DHA-PPQ group,     according to the PCR adjusted results, 6 subjects had Late treatment Failures. In the MAS3     group, two Late Treatment Failures was reported. The frequency of adverse events was     significantly lower in patients treated with DHA-PPQ than in those treated with MAS3.      DHA-PPQ proved to be a highly effective antimalarial drug for the treatment of P. falciparum     malaria and suitable for use in the Peruvian Amazon region. It also has the advantage of     being better tolerated. In terms of cost, DHA-PPQ is cheaper and more affordable than MAS3     and should be considered for the National Antimalarial Drug Policy in Perú.   "
193118|NCT00373620|"     The purpose of this study is to determine whether post-operative concurrent chemoradiation     with paclitaxel is effective and safe in the treatment of high risk postoperative endometrial     cancer patients.   "
193119|NCT00373633|"     We will compare thoracic epidural anesthesia which is presently used for management of pain     after thoracotomy to an intra-operatively placed extrapleural intercostal catheter. The study     wil be double blinded and prospective.   "
193120|NCT00373646|"     The purpose of this study is to evaluate Thalidomide for treatment of disseminated MALT     Lymphoma or at relapse following helicobacter pylori (HP) - eradication or chemotherapy or     radiation.   "
193121|NCT00373659|"     This study was designed to evaluate a variable dosing regimen with intravitreal ranibizumab     for the treatment of patients with neovascular age-related macular degeneration (AMD) in the     Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular     Ranibizumab (PrONTO) study.   "
193122|NCT00373672|"     This is a six week, double blind,placebo controlled study for patients with schizophrenia or     schizoaffective disorder treated with an atypical antipsychotic for at least two months.     Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current     antipsychotic and tested at baseline and week 6 for differences in memory, attention and     problem-solving ability. Changes in weight during the six week study will also be tracked.   "
193123|NCT00373685|"     This study investigates if Celebrex has a lower incident of Gastrointestinal Events than     other NSAIDS in subjects with osteoarthritis.   "
193124|NCT00373698|"     The study is an evaluation of a systemic intervention to enhance the delivery of care     according to practice guidelines for posttraumatic stress disorder (PTSD). The immediate     objectives are to (1) implement three component model (3CM) in VA primary care clinics; and     (2) evaluate the effects of 3CM on clinician behavior and patient outcomes. The long-term     objectives are to generate information to support implementation research on the RESPECT     model for treating PTSD in primary care and ultimately, the implementation of the model in     VHA to provide care to veterans with PTSD.   "
193125|NCT00373711|"     The management of thyroid cancer patients with suspicion of recurrent disease based on     rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body     scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected.     The use of another iodine isotope (I-124) with positron emitting characteristics for PET/CT     may allow better identification of recurrent disease, thus allowing for more patients to be     treated with I-131 as a curative attempt.   "
193126|NCT00373724|"     In order to determine whether L4 and L5 primary dorsal rami and S1-3 lateral branch     radiofrequency denervation is effective for sacroiliac (SI) joint pain, we are conducting a     randomized, controlled study.   "
193127|NCT00373737|"     This study aims to study the gene expression profiles of liver tumors to help us understand     their biology, and to find new tumor and treatment markers for liver cancer.   "
193128|NCT00373750|"     The purpose of this study is to determine whether an in-home, paraprofessional-delivered     family strengthening curriculum entitled Family Spirit is effective at increasing parental     competence, improving maternal outcomes and improving childhood outcomes in a sample of     at-risk teen mothers living in four Native American reservation communities. The     effectiveness of the Family Spirit curriculum will be determined by comparing outcomes of     mothers who receive the intervention plus assisted transportation to prenatal and well baby     visits (called Optimal Standardized Care) to mothers who receive only Optimal Standardized     Care. Outcomes will be assessed at multiple intervals over the course of a 39-month study     period.   "
193129|NCT00373763|"     Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to     lung underdevelopment. Clinical experience from prospective controlled non-randomized case     series with fetoscopic tracheal balloon occlusion has seen improved survival rates in     contrast to untreated controls. Therefore, the purpose of this randomized clinical trial is     to provide further evidence about the efficacy and safety of the prenatal interventional     approach. Primary outcome measure is postnatal survival to discharge from hospital treatment.   "
193130|NCT00373776|"     This trial will study miltefosine as a treatment for mucosal leishmaniasis.   "
193131|NCT00373789|"     The purpose of this study is to see whether Botox A (injected into the bladder muscle) can     improve symptoms of urge incontinence that has not improved with usual medical treatments.   "
193132|NCT00373802|"     Drops of either saline or phenylephrine are placed in the nose of infants less than 12 months     of age to determine if it helps them to breathe easier.   "
193133|NCT00373815|"     The present protocol is a dose-finding and toxicity study in preparation of a randomised     study comparing current standard treatment CSA/prednisolone with the new combination     CSA/prednisolone/everolimus.   "
193179|NCT00374413|"     The purpose of this study is to show that the Kineflex|C Spinal System is no worse than     conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level     degenerative disc disease at any cervical level from C3 to C7.   "
193134|NCT00373828|"     The overall aim of the project is to evaluate diagnosis and treatment of chest pain     originating from the musculoskeletal system. Specifically, we wish to investigate prevalence     and character of such chest pain in a population of patients with acute chest pain, admitted     to a university hospital based acute chest pain clinic, and undergoing evaluation of acute     coronary syndrome (Part 1). Then, to test a manually-based treatment protocol to patients     with diagnosed musculoskeletal chest pain in a randomized clinical trial (Part 2).      The specific purpose of this study (Part 1) is to determine the exact number of patients with     acute chest pain origination from the musculoskeletal system, and to describe their cardiac     status with respect to ischemic heart disease. Further, we wish to evaluate the decision     making process of the chiropractor.   "
193135|NCT00373841|"     The purpose of the study is to identify genetic and biologic markers that may predict the     loss of lung function due to idiopathic pulmonary fibrosis. The studies will compare genetic     and biologic markers of samples to changes in symptoms. The ultimate goal is to predict if or     when patients are likely to experience a rapid decline in lung function due to disease     progression.   "
193136|NCT00373854|"     Hypothesis: Low blood sugar (hypoglycemia) decreases function of the lining of the blood     vessels in normal humans.      This study is designed to explore how hypoglycemia affects the function of the blood vessel     lining. This will be determined by measuring blood flow to the arm before and after occlusion     of flow. Blood vessel function will be measured before induction of hypoglycemia, during     insulin induced hypoglycemia, and after recovery from hypoglycemia. A second study will be     done but without hypoglycemia.   "
193137|NCT00373867|"     Low back pain is a very common problem and the most common cause of job-related disability.     While some occurrences of low back pain disappear within a couple of days, other occurrences     take much longer to resolve or lead to more serious conditions. The purpose of this study is     to determine the effectiveness of two behavioral types of therapy in reducing future     disability in people who are receiving physical therapy for low back pain and tend to fear     and avoid pain.   "
193138|NCT00373880|"     The purpose of this study is to investigate whether aripiprazole will decrease cocaine     self-administration, subjective effects and cravings compared to placebo.   "
193139|NCT00373893|"     To determine the effects of Lidocaine patch on the pain and hyperalgesia induced by     intradermal capsaicin   "
193140|NCT00373906|"     Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP     -eradication,or chemotherapy or radiation.   "
193141|NCT00373919|"     Cervical anastomotic leak is one of the most common complications after trans-hiatal     esophagectomy.      Hypothesis: An early post operative administration of a pro-kinetic dosage of erythromycin     will reduce leak occurrence.      Design: This is a prospective, randomized, double blind, placebo controlled study.      Number of patients: 30.      Inclusion Criteria:        -  Patients after trans-hiatal esophagectomy      Exclusion Criteria:        -  Allergy to erythromycin        -  Use of phenothiazine        -  QT prolongation        -  Liver function test (LFT) abnormalities        -  Myasthenia gravis        -  Cardiomyopathy   "
193142|NCT00373932|"     The purpose of this exploratory study is to determine the feasibility, acceptability, and     efficacy of an exercise persistence intervention for patients with chronic obstructive     pulmonary disease (COPD) following pulmonary rehabilitation (PR).   "
193143|NCT00373945|"     This retrospective case-control study is being conducted to estimate the sensitivity of the     pharmacogenetic marker, HLA-B*5701 for hypersensitivity to abacavir (ABC HSR). The     specificity of the marker, and its association with ABC HSR, as measured by odds ratios and     95% confidence intervals, will be evaluated as secondary endpoints. Cases will be defined in     two ways - subjects who have clinically-suspected ABC HSR and a positive abacavir skin patch     test reaction (CS-SPTPos) and subjects with clinically-suspected ABC HSR (CS-HSR), regardless     of the results of skin patch testing. The study will include 40 CS-SPTPos Black cases matched     with up to 200 abacavir-tolerant controls. In parallel, 40 CS-SPTPos White cases will be     matched with up to 200 White controls. Some of the secondary analyses will use cases defined     by clinical criteria alone (CS-HSR). Black and White subjects will be analyzed separately     because of the differences in ABC HSR rates and in the carriage frequency of HLA-B*5701.   "
193144|NCT00373958|"     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the     13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC)     and to compare the immune response to concomitant vaccines administered with 13vPnC and     7vPnC.   "
193145|NCT00373971|"     Malnutrition of elder orthopaedic patients leads to weight loss and loss of fat free mass.     Changes in the individual’s nutritional status and body composition may adversely affect the     patient’s postoperative level of activity.      Aim. Thus, the purpose of the present study is to report changes in postoperative weight, FFM     and functions vital to daily living in a group of elder orthopaedic patients that were     actively involved in their nutritional care during the hospital stay.   "
193146|NCT00373984|"     Patients undergoing chest surgery (thoracotomy) often develop shoulder pain after their     operation despite epidural pain control of the incision. We plan to study the incidence of     this phenomenon in our institution to determine whether there are patterns that may predict     those persons at highest risk of developing this type of pain. Further, we hope to determine     whether newer surgical techniques have an impact on the development of this type of pain.   "
193147|NCT00373997|"     The purpose of the study is to determine whether patients with suspected Laryngopharyngeal     reflux have inflammation and ultrastructural injury on their laryngeal biopsies.   "
193148|NCT00374010|"     The specific aims are:        1. to evaluate the feasibility and acceptability of PC-ACP among African American patients          with End-stage Renal Disease and their surrogates and        2. to examine preliminary effects of PC-ACP on patient and surrogate outcomes (patients'          perceived quality of communication, surrogates' level of comfort in decision making for          the patient, patients' difficulty in making choices, patient-surrogate congruence in          goals of care, and patients' and surrogates' psychosocial/spiritual receptiveness) at          one week following receipt of the intervention.   "
193181|NCT00374439|"     The purpose of this study is to evaluate the efficacy of a cognitive-behavioral vs. an     interpersonal therapy program for preventing depressive symptoms in adolescents.   "
193149|NCT00374023|"     Vitamin A deficiency in children is associated with increased mortality and morbidity due to     respiratory tract and diarrhoeal infections. Vitamin A supplementation has been shown in some     studies to reduce morbidity due to respiratory diseases. However, other studies to reduce     could not document such benefit from vitamin A supplementation. The role of vitamin A on     immunity in humans is not yet clear due to inconclusive results. To evaluate immune changes     and compare those with of a known immunopotent agent like zinc, a randomised double blind     study will be carried out in 1-3 year aged children without acute illness and wt/age between     61% and 70% of NCHS standard. Baseline anthropometry and vitamin A status will be determined     using MRDR test and immune status will be estimated. Each group consisting of 50 children     will either receive vitamin A 200,000 IU over 7 days or 40 m elemental zinc daily for 7 days     or both or placebo. After 8 weeks immunity test will be repeated. Immunity tests will include     serum 1gA, 1gM, 1gG an lymphocyte simulation and 8 antigen multiple skin test. Undiminished     children will be given measles vaccine and serum titre will be measured before and after     supplementation. Vitamin A status will be estimated by MRDR test. Vitamin A2 will be given     and 1ml blood sample will be collected after 5 hours to see the ratio of vitamin A1 and A2     (<0.06 as cut off) as the modified relative dose response (MRDR test). Doses of vitamin A or     zinc will be repeated at the completion of 2 month. The results will be compared between     groups and within groups at baseline and after 6 weeks. The study will generate information     which will help to examine the immune response of vitamin A therapy in children as an     underlying factor for reduction in mortality or morbidity. The study will be completed within     a year.   "
193150|NCT00374036|"     The purpose of this study is to compare the effectiveness of 2 different sequences of     polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally     advanced or metastatic.   "
193151|NCT00374049|"     The purpose of this study is to determine the effectiveness of a drug called Poly-ICLC, also     known as HiltonolTM, in boosting the body's immune system's response to an experimental     vaccine therapy (called the MUC-1 vaccine).   "
193152|NCT00374062|"     The goal of this study is to determine if relaxation therapy improves patient satisfaction     with Mohs micrographic surgery.   "
193153|NCT00374075|"     This is an open label phase I/II clinical trial to assess safety, tolerability and potential     effect on SMN mRNA and protein in vivo of a compound in which preliminary evidence supports a     potential effect on SMN levels in vitro.   "
193154|NCT00374088|"     The purpose of this study is to determine whether intravenous N-acetylcysteine (also known as     Acetadote), an antioxidant medication that has been used for years to treat Tylenol overdose,     helps prevent heart dysfunction in the early postoperative period following congenital heart     surgery. Children undergoing major heart surgery, such as the arterial switch operation,     routinely develop temporary heart dysfunction in the first 12-24 hours after surgery. This     heart dysfunction may be severe and contributes to an increased risk for death or prolonged     hospitalization. Current standard treatments include intravenous medications such as     dopamine, epinephrine, and vasopressin that support your child's blood pressure and heart     function. Unfortunately, high doses of these medications have the potential to cause severe     side effects including loss of fingers and toes, liver and kidney dysfunction, and heart     rhythm abnormalities. Our goal is to find a way to reduce heart dysfunction after major heart     surgery in order to promote a smoother postoperative period, and reduce the risks associated     with heart operations in children.   "
193155|NCT00374101|"     High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in     bleeding peptic ulcers successfully treated by endoscopic therapy   "
193156|NCT00374114|"     Ultrasonic surgical aspiration of the cervix may be an effective method of treating cervical     dysplasia without compromising the integrity of the cervix in reproductive age women.   "
193157|NCT00374127|"     The purpose of this study is to investigate whether or not marijuana blunts will produce     comparable plasma THC levels as marijuana joints and if blunts will produce larger     cardiovascular and subjective effects.   "
193158|NCT00374140|"     This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001     (everolimus) in patients with previously treated small cell lung cancer. RAD001 will be     administered orally at a dose of 10 mg daily.   "
193159|NCT00374153|"     The purpose of this study is to look at the effects of assessment, feedback and motivational     interviewing on alcohol consumption among college drinkers.   "
193160|NCT00374166|"     The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and     100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with     generalized anxiety disorder   "
193161|NCT00374179|"     RATIONALE: CT-322 may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping     blood flow to the cancer.      PURPOSE: This phase I trial is studying the side effects of CT-322 in treating patients with     advanced solid tumors or non-Hodgkin's lymphoma.   "
193162|NCT00374192|"     To examine the change in sleep patterns and mood symptoms in response to eszopiclone     (Lunesta) using a double-blind placebo-controlled cross-over study design in perimenopausal     and postmenopausal women who experience insomnia, mild depression and/or anxiety.   "
193163|NCT00374205|"     The purpose of this study is to compare the effectiveness and safety of two Artemisinin     Combination Therapies (ACTs) for the treatment of children with uncomplicated Plasmodium     falciparum malaria   "
193164|NCT00374218|"     Weight gain is linked to a high consumption of soft-drinks and other beverages sweetened with     high fructose corn syrup. Being overweight increases risk for diabetes and heart disease.     These problems may be due to high blood glucose and insulin responses caused by high fructose     corn syrup. Sucromalt is a sweetener which contains the same amount of carbohydrate at high     fructose corn syrup, but causes lower glucose and insulin responses. The purpose of this     study is to see if consuming soft-drinks and other foods sweetened with sucromalt instead of     high fructose corn syrup will result in lower levels of blood glucose, insulin, cholesterol     and other markers of risk. We are including in this study people who are overweight and     normally consume soft-drinks because they are the ones most likely to benefit from this     change.   "
193165|NCT00374231|"     To determine the safety and efficacy of early corticosteroid discontinuation in liver     transplant recipients more than 90 days post transplant, utilizing a combination of two drugs     (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.   "
193166|NCT00374244|"     This is a 12 week outpatient study for patients with schizophrenia who are on Clozapine, but     continue to experience symptoms. The purpose of this project is to find out if small doses of     pimozide (an antipsychotic medication, taken by mouth) will be helpful in reducing symptoms     (such as hearing voices, having trouble in organizing your thoughts, lack of interest in life     events and social activities), compared to placebo (an inactive substance, sugar pill),     when added to clozapine in patients with schizophrenia.      The participant will be asked to come in once a week to meet with the research staff and     study doctor. The participant will continue to see your regular clinician during this study     for all normal appointments. The participant will remain on your current medications     throughout the study. During the study you will be randomly selected to be put on a small     dose of Pimozide or placebo.   "
193167|NCT00374257|"     The purpose of this trial is to find out how effective Narrow Band-Ultraviolet Light B     (NB-UVB) phototherapy is in treating oral cGVHD. NB-UVB Phototherapy involves exposing the     inside of the mouth to light of a particular spectrum (a specific wavelength of light, 311nm)     of the ultraviolet band, called NB-UVB. It is known that narrow band ultraviolet light     therapy can improve symptoms in patients with skin chronic GVHD.   "
193168|NCT00374270|"     About 22% of Canadians have high blood pressure, or hypertension. However, studies have shown     that only 1 out of 5 people with hypertension have their blood pressure controlled.      Diabetes is also an important risk factor for heart disease and stroke. About half of people     with diabetes also have hypertension - a deadly combination. Studies have shown that only     about 1 in 10 people with diabetes have their blood pressure controlled adequately - clearly     something needs to be done to improve this.      Heart disease, stroke, hypertension, and diabetes are conditions that occur in the community,     so we need to explore innovative solutions that will work in the community. Pharmacists are     well-placed in the community to help identify people with diabetes and hypertension. This has     worked very well in previous studies in patients with high cholesterol levels. Pharmacists     and nurses have complementary skills which, when working as a team, may help identify and     better manage hypertension in people with diabetes.      Our main objective is to test whether a community pharmacist and nurse team can improve blood     pressure control in people with diabetes and hypertension.   "
193169|NCT00374283|"     Evaluate techniques for monitoring the course of interstitial therapy for polyomavirus     nephritis in kidney and kidney pancreas transplant recipients by monitoring blood, urine, and     renal transplant biopsies of patients affected by polyomavirus.   "
193170|NCT00374296|"     In this study, MGCD0103, a new anticancer drug under investigation, is given three times per     week to elderly patients with previously untreated acute myelogenous leukemia/high risk     myelodysplastic syndrome or adults with relapsed/refractory disease.   "
193171|NCT00374309|"     This study will determine if an experimental vaccine to prevent Ebola virus infection is safe     and what side effects, if any, it causes. Ebola virus infection may range from mild to     severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can     lead to death. The vaccine used in this study contains man-made genetic material similar to     one part of the Ebola virus, which is designed to stimulate an immune response to the virus.     The vaccine itself cannot cause Ebola virus infection because it does not contain any Ebola     virus.      Participants are assigned to one of three groups as they enter into the study. Of the first     16 people in the study, 12 receive the lowest study dose of vaccine and 4 receive placebo (an     inactive substance). If this dose is safe, then of the next 16 people who enter the study, 12     receive a higher dose of the vaccine, and the remaining 4 receive placebo. If this dose is     safe, the final 12 people in the last group of 16 receive the highest study dose, and 4     receive placebo. The vaccine is given as a single injection in the arm on the day of     enrollment.      Participants keep a diary for 5 days, recording their temperature, symptoms and any reaction     at the injection site. They call a study nurse the day after vaccination to report how they     feel, and they return to the clinic approximately six times for follow-up evaluations. These     visits may include a check of vital signs, physical examination, blood and urine tests, or     other medical tests if needed.   "
193172|NCT00374322|"     This study was designed to evaluate and compare the safety and efficacy of an oral dual     tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage     ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant     chemotherapy and have no clinical or radiographic evidence of disease.   "
193173|NCT00374335|"     This study will attempt to determine how common liver hemangiomas are in children with     infantile hemangiomas by comparing liver ultrasound results in patients with 1-4 cutaneous     hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma versus     ultrasound results in children without hemangiomas. Other objectives of the study include     identifying specific risk factors in patients who have liver hemangiomas and identifying risk     factors in children with symptomatic liver hemangiomas.   "
193174|NCT00374348|"     To evaluate the effectiveness of flexible doses (15-30mg) of Aripiprazole in the treatment of     patients with schizophrenia and co-morbid symptoms of OCD in the outpatient setting. The     overall effectiveness of Aripiprazole will be evaluated by use of the Brief Psychiatric     Rating Scale(BPRS), Yale-Brown OCD scale and Clinical Global Impression-Improvement(CGI-I)     scale.   "
193175|NCT00374361|"     This study is designed to determine whether there is a relationship between the way insulin     and blood vessels work. The difference in the interaction between Caucasian and African     American adolescents will also be examined. This may play a role in the differing rates of     heart disease and diabetes between the two groups.   "
193176|NCT00374374|"     The purpose of this study is to determine whether a probiotic containing Lactobacillus     Acidophilus and Lactobacillus Rhamnosus is effective as treatment for patients with active     colonic Crohn's disease   "
193177|NCT00374387|"     75 heterosexual women are asked to use 3 different types of contraception (Nuvaring, low-dose     combination pill, minipill), each during 3 months. On a monthly basis, questionnaires are     filled out about sexual desire and psychosocial, relational en sexual parameters. Also the     sexual desire of the partner is questioned. On a three-monthly basis, blood samples are drawn     to determine changes in hormonal parameters (one sample per product period).      75 lesbian women are doing the same trial, but during an extra 3 months period, they are     asked to have their natural menstrual cyclus as a control condition. Blood samples during     these extra months will be drawn at the third or fourth day after start of the menses.   "
193182|NCT00374452|"     This project is a VA HSR&D-funded Quality Enhancement Research Initiative (QUERI) project to     translate into practice evidence about clinical management of primary hypertension. The     project aims to contribute to quality improvement of care for patients with primary     hypertension. The project will implement a clinical decision support system for primary care     clinicians and will evaluate the implementation by studying the impact on the clinicians'     prescribing and their patients' blood pressures, and will also study organizational factors.   "
193183|NCT00374465|"     The aim of this study is to compare the effect of treatment with verapamil or carvedilol on     long-term outcomes in stable, chronic heart failure secondary to non-ischemic cardiomyopathy.   "
193184|NCT00374478|"     The purpose of this study is to determine the effects of Transdermal scopolamine vs. placebo     on ship navigation performance under simulated heavy sea conditions.   "
193185|NCT00374491|"     The purpose of the study is to evaluate the long term outcome of a poly L-lactic acid /     β-tricalcium phosphate (BILOK) biodegradable interference fixation screw used for     arthroscopic bone-patellar tendon-bone ACL reconstruction,to determine if these BILOK screws     completely biodegrade as expected three years after implantation, and to determine whether     there is bone ingrowth into the defect remaining after resorption of the BILOK screw.   "
193186|NCT00374504|"     The aim of this study is to evaluate a possible correlation between predictive precesarean     section pain and development of postcaesarean section pain using the PM.      Patients and Methods 46 healthy pregnant women scheduled for elective cesarean section is     included after informed consent. The standard operation procedures included spinal     anesthesia, paracetamol 1 g 8 hourly, diclofenac 50 mg 8 hourly and oxycontine 10 mg x 2.     Morphine was used for break-through pain.      Before cesarian section the threshold for sensory and pain were measured 3 times, and the     average was used for analyses. After cesarian section a blinded midwife assess the pain at     rest and during mobilization every 12th hours over 2 days score.      Data was analyzed using AUC and non-parametric test, P < 0,05.   "
193187|NCT00374517|"     This study will determine whether a drug called pimonidazole hydrochloride shows areas of low     oxygen in tuberculosis (TB)-infected lungs. Pimonidazole is a low oxygen marker, an agent     designed to find areas in the body that are not getting enough oxygen. If it is found that TB     grows where oxygen is low, these results may help doctors decide what medicines would be most     effective for treating TB.      Patients 20 years of age or older who are scheduled for lung surgery at the National Masan     Tuberculosis Hospital in Masan, Korea to treat their TB may be eligible for this study.      Participants undergo the following procedures:        -  Blood draw before surgery to test for hepatitis B and hepatitis C viruses.        -  Pregnancy test for women who can become pregnant.        -  Infusion of pimonidazole through a vein in the arm 24 hours before surgery. A part of          the patient's lung is removed during surgery. This tissue is examined under a microscope          for evidence of pimonidazole, which would indicate low oxygen.        -  Blood sample collection during surgery and on the 7th and 14th days after surgery to          check liver function.   "
193188|NCT00374530|"     Before, during and after intravenous administration of PGE2 we score/measure headache, rCBF,     blood flow in the middle cerebral artery and diameter of superficial temporal artery and     correlate that to known pathophysiology of headache to see if PGE2 is involved in headache     pathophysiology.   "
193189|NCT00374543|"     This study proposes to examine the potential safety and efficacy of ziprasidone for patients     with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of     quality of life and resilience.   "
193190|NCT00374556|"     This research is being done to evaluate the effects of a sleeping pill (eszopiclone,     Lunesta)in patients with arthritis of the knee who also suffer from chronic insomnia. This     study will test whether Lunesta improves sleep, pain sensitivity, and daytime symptoms in     patients with knee pain.   "
193191|NCT00374569|"     One aim of this study was to find if there was a difference between balance and stability     between elite level gymnasts and non-gymnasts. Another aim was to find if there was a     relationship between dynamic posturographic scores associated with sway fatigue or     adaptability and the ability to learn new gymnastic routines. The ultimate aim of the study     was to improve gymnastic performance while reducing the probability of injury.   "
193192|NCT00374582|"     The purpose of this research study is to see how effective bioelectric impedance analysis     (BIA) is in determining body composition (the amount of fat versus muscle in the body) and     nutritional status in patients with End Stage Liver Disease (ESLD)   "
193193|NCT00374595|"     Hypothesis: Nontraditional risk factors, such as inflammation, vitamin D deficiency, elevated     PTH, insulin resistance, homocysteine, or uric acid, contribute to cardiovascular disease     progression after kidney transplant.      The purpose of this study is to evaluate which traditional and nontraditional cardiovascular     disease risk factors best predict progression of cardiovascular disease (CVD) using carotid     intima media thickness performed by ultrasound, in kidney transplant patients.   "
193194|NCT00374608|"     The purpose of this study is to evaluate the exercise capacity of patients with complete     heart block who are chronically being paced from the right ventricle. Also, we hope to     correlate the level of uncoordinated contraction with the patients exercise capacity. We will     enroll patients with complete heart block as diagnosed by standard electrocardiographic means     and now have a permanent pacemaker. All patients we approach for this study will receive an     echocardiogram to assess their heart function. As part of the echocardiogram, they will also     receive a Tissue Synchronization Imaging (TSI) evaluation to assess the level of     uncoordinated contraction they have. The patients will then be subjected to a cardiac     exercise stress test which will involve them running on a treadmill until they cannot     continue while data is collected regarding their heart's response to exercise. All portions     of the study are noninvasive, which means they work from probes and monitors outside the     body.   "
193195|NCT00374621|"     The purpose of this study is to determine the efficacy and safety of the addition of     intravaginal isosorbide mononitrate to an established protocol of oral misoprostol for     cervical ripening and labor induction.   "
193196|NCT00374634|"     The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given     in individual doses, according to a nomogram we have constructed based on our results from a     previous study, results in more patients maturing 2-3 follicles compared to standard dose.   "
193199|NCT00374673|"     Objectives : To investigate the analgesic effects of repeated sessions of unilateral rTMS in     patients with chronic pain syndrome due to fibromyalgia, IBS or burning mouth syndrome.     Primary outcome will be numerical pain scores.      Methods : The study will be randomized and performed in parallel groups and double blind     versus sham stimulation, and will include 90 patients (45 patients per treatment arm). The     randomization will be computerized and performed for each aetiological group separately. The     rTMS will be performed on the left motor cortex, 5 consecutive days , then once a week during     3 weeks then twice a month during 2 months, then once a month during 6 months. Clinical     assessment will include an assessment of pain, quality of life, sleep, depression and     anxiety, catastrophizing, and a neuropsychological evaluation.      Conclusion : this study should allow to determine for the first time the long term efficacy     and safety of rTMS in the treatment of dysfunctional or idiopathic chronic pain syndromes     which are often refractory to conventional treatments.   "
193200|NCT00374686|"     This is a study of prophylactic Vs preemptive oral valganciclovir for management of     cytomegalovirus infection in adult renal transplant recipients looking at clinical and     pharmacoeconomic outcomes   "
193201|NCT00374699|"     Peripheral T-cell lymphomas (PTCLs) are neoplasias from post-thymic T-cells at different     stages of differentiation and are a heterogeneous group of malignancies which present with     different morphological patterns, phenotypes, and clinical presentations.      These tumours have a striking epidemiological distribution with a lower incidence in Western     countries than in Asia. In Korea, PTCLs including T- or natural killer (NK)-cell lymphomas     constitute approximately 25 to 35% of all non-Hodgkin's lymphomas. This incidence is quite     similar to that of other Eastern Asian countries, including Japan, Hong Kong, and China.      Recent studies suggest that the T-cell phenotype is an independent significant prognostic     factor, with PTCLs having one of the lowest overall survival and failure-free survival rates.     Based on the investigator's experience, the overall complete remission rate was 61.2% (95%     confidence interval [CI]: 48.5-72.8%) and the 5-year probability of failure-free survival was     33.5%. Median survival of all patients was 45 months (range 0-64+ months) and the 5-year     probability of survival was 36.2%. Rassidakis et al. reported that expression of     pro-apoptotic proteins BAX and BCL-XS, may explain the poor response of many types of PTCL to     standard chemotherapy.      To overcome such poor outcome, the optimal therapy for PTCLs remains to be defined. However,     because of the rarity of the disease in Western countries, only a few trials have been     reported.      Bortezomib (Velcade) is a modified dipeptidyl boronic acid, and a reversible inhibitor of the     chymotrypsin-like activity of the 26S proteosome. Bortezomib may induce tumor cell apoptosis     or decreased bcl-2 associated drug resistance. Through phase II studies, single agent     bortezomib in patients with relapsed indolent and mantle cell lymphomas showed its activity.     And also preliminary data indicate that bortezomib can be safely administered in combination     with dose adjusted etoposide, prednisolone, vincristine, cyclophosphamide and doxorubicin     (EPOCH) chemotherapy. Therefore, it can be possible to improve the poor outcome of patients     with PTCLs by a combination of cyclophosphamide, doxorubicin, vincristine, prednisolone     (CHOP) with bortezomib as a first-line therapy.      Primary Hypothesis: Based on the clinical trials and experimental data, bortezomib can     overcome pro-apoptotic proteins BAX and BCL-XS induced drug resistance.   "
193202|NCT00374712|"     Patients with chronic kidney disease (CKD) and those with end-stage renal disease (ESRD)     undergoing renal replacement therapies show elevated serum phosphate levels which predispose     them to cardiovascular calcifications and high risks of death from cardiovascular diseases.     However, in certain patients hyperphosphatemia is not related to dialysis insufficiency,     excessive daily dietary phosphorus intake or high serum parathyroid hormone (PTH) levels,     suggesting that other mechanisms could be involved. Transgenic mice lacking the klotho gene     showed a phenotype which resembles that of dialyzed ESRD patients, in the sense that they     have hyperphosphatemia, vascular calcifications, and a short lifespan. This study will     analyze whether functional polymorphisms or variants in the human klotho gene are associated     with hyperphosphatemia in these patients.   "
193203|NCT00374725|"     In this trial we test the hypothesis that a probiotic containing Lactobacillus acidophilus     and Lactobacillus rhamnosus is an effective therapy for patients with ulcerative colitis.   "
193204|NCT00374738|"     Our specific aims are:        1. To examine the efficacy of GIFT in improving MST-related clinical outcomes in women          veterans        2. To examine the effects of GIFT on fronto-limbic brain function and        3. To examine the effects of GIFT on levels of neuroactive steroid associated with PTSD.   "
193205|NCT00374751|"     Cancer cells may spread from the primary site to the vertebrae resulting in their deformity.     The standard treatment for this case is removal of the cancer deposits in the vertebra and     filling the induced cavity with a cement like substance.      We are studying the effects (good or bad) of adding samarium (a radioactive substance) to the     cement that is injected into the induced cavity.   "
193206|NCT00374764|"     Hypotheses:        1. Preschool children with autism spectrum disorders (ASDs) who undergo ABA treatment only          will demonstrate significantly better outcomes compared to an age and severity matched          control group without ABA treatment.        2. Preschool children with ASDs who undergo ABA in combination with risperidone will          demonstrate significantly better outcomes compared to age and severity matched children          who are receiving ABA alone.        3. Young age, cognitive development and attentional abilities at baseline will be          predictive of good socio-emotional and neuropsychological outcomes after ABA treatment.        4. At baseline, children with ASDs will show significantly lower performances on measures          of cognitive, neuropsychological, and socio-emotional functioning than age-matched          typically developing controls.   "
193207|NCT00374777|"     A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo     and nitrazepam as a comparative drug.   "
193208|NCT00374790|"     The purpose of this study is to compare the efficacy of iron (12.5 mg as ferrous sulfate) and     placebo given for 6 months in preventing the elevation of blood lead concentration in     children 6-9 months of age.   "
193209|NCT00374803|"     To determine the safety and efficacy of a new formulation of Myfortic in combination with     tacrolimus and thymoglobulin.   "
193225|NCT00375024|"     Patient Navigation is a Supportive Care Intervention that addresses barriers to quality     standard care by providing individualized assistance to patients and families. The NCI is     conducting several research programs to test the effectiveness of this approach. The expected     outcomes of patient navigation through the cancer care system include:        -  Timely, definitive diagnosis following an abnormal test        -  Timely treatment following positive diagnosis        -  Patient satisfaction with the diagnostic and care system experience   "
193226|NCT00375037|"     This randomized controlled trial will evaluate the effect of a multifaceted intervention     including performance feedback on adherence to hand hygiene among healthcare workers. A key     component of the study is to demonstrate whether improved adherence to hand hygiene leads to     a reduction in rates of infection.   "
193210|NCT00374829|"     The study is a randomised controlled trial to evaluate the impact of a program using     information technology (IT) and healthcare professional support in patients with high blood     pressure (BP) compared to usual care. The program helps patients monitor their own BP and     medication and keeps nurses,physicians and pharmacists informed while respecting patient     confidentiality. The IT system links directly with the patient's pharmacy data. Using     pharmacy data and responses to questions on compliance and BP control, the IT system provides     appropriate counselling, telephone reminders, generates prescription refill and renewal     reminder calls and monitors BP. The system reports compliance and self recorded BP     measurements to healthcare providers and also links with a nurse. This is so that the nurse,     the patient's doctor and pharmacist can help answer questions about medication and     controlling high blood pressure.      A total of 500 patients in Laval, Quebec will participate in the study. Half of the patients     will have the program plus usual care and the other have usual care only. We hypothesize that     the program will improve BP control by helping patients take their medication properly and by     helping doctors ensure that the best strength and kinds of medication are used to control     high blood pressure. We believe the program will achieve this by helping to improve     communication between patients and healthcare providers, without adversely impacting quality     of life. Additional sub-studies will determine if the program is cost effective and can be     applied in real practice and if the program helps patients, doctors, pharmacists and nurses     communicate better.   "
193211|NCT00374842|"     The purpose of this study is to evaluate the immunogenicity and the safety of candidate     vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years   "
193212|NCT00374855|"     The primary objective of this study is to test the hypothesis that LY518674, administered for     6 weeks to patients with mild hypertension, reduces Systolic Blood Pressure, compared with     placebo.   "
193213|NCT00374868|"     To assess the anti-tumor activity, as measured by response rate to bi-weekly pemetrexed plus     cisplatin, in chemo-naive patients with diagnosed metastatic or locally advanced     (non-resectable) urothelial cancer.   "
193214|NCT00374881|"     Efficacy and Safety of the combined oral adjuvants phenylephrine and sorbitol on oral low     dose morphine analgesia.   "
193215|NCT00374894|"     Lead poisoning remains a common disease among children despite successful public health     efforts that reduced its prevalence.Our study was designed to test the hypothesis that     lead-poisoning children (BLLs:100-440µg/L) who were given DMSA and multi-nutrients would have     a greater fall than children of other groups at 12 weeks of follow-up.   "
193216|NCT00374907|"     The purpose of this clinical research study is to learn whether Saxagliptin can improve the     body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes   "
193217|NCT00374920|"     The purpose of this study is to establish the potential of MEM 1003 as a safe and effective     treatment for patients with an acute manic or mixed episode of bipolar disorder.   "
193218|NCT00374933|"     This is a new platform in non-myeloablative allogeneic stem cell transplantation to improve     survival by harnessing the immunologic potential of donor T-cells to induce and maintain     long-term remissions in patients with hematologic malignancies without undue toxicity. This     study involves is the first study in humans directed at optimizing the graft vs leukemia     effect by infusing activated T-cells from healthy donors prophylactically, months after     recovery from the initial transplant. Investigators are studying whether the activation of     donor cells prior to infusion will enhance the patient's ability to seek and destroy     residual malignant cells while also helping the immune system to fight infection without     increasing the immune reaction against the host.   "
193219|NCT00374946|"     Clinical evaluation of 4 different bearings in THA. Primary parameter being prosthetic     survival data.   "
193220|NCT00374959|"     The primary purpose of the trial is to compare the efficacy and safety of two measures which     claim to prevent early-onset ventilator-associated pneumonia.   "
193221|NCT00374972|"     Objective: To determine and compare the effect of low dose estrogen combined hormonal     contraceptives and progestin-only contraceptives on lactation.      The subjects will be drawn from a healthy obstetric population in each center, where possible     preliminary contact during antenatal period. At the postpartum visit, subjects that express     their wish for a hormonal contraceptive method will be offered enrollment. After obtaining an     informed consent the participants will be allocated according to their free wish to either     receive a combined preparation containing 0.02 mg ethylestradiol and 0.15 mg desogestrel     (Mercilon, Organon) or a progestin only pill containing 0.075 mg desogestrel (Cerazette,     Organon). Demographic, habits and perinatal data will be collected and stored to analysis.      Frequency and methods of observation: All women will be followed at 6 (baseline), 9 and 12     weeks post - partum. Instruction will be given as to recording information on intercurrent     disease, frequency of nursing and use of complementary formula supplements. Maternal BMI     calculation ( weight/height2) will be obtained at first visit.      The objective is to compare the capacity of the breast to secrete milk under standard     conditions and evaluate the influence of different hormonal contraception means. Thus samples     will be collected at 6 weeks (enrollment) and the 9 and 12 weeks visits. An Egnell pump will     be used for a maximum of 20 minutes form from both breasts, simulating a regular breast     feeding. A total of 10 ml aliquot will be taken for composition analysis and the rest will be     offered to the infant. The milk volume/feeding will be estimated and expressed in ml/feeding     and multiplied by the number of feedings reported.      Outcome variables: Milk volume, infant growth at each visit and biochemical markers of milk     analysis : lipid, casein and carbohydrate content   "
193222|NCT00374985|"     The purpose of this study is to determine the dose limiting toxicity and the maximum     tolerable dose of the radiochemotherapy with Docetaxel and Oxaliplatin in patients with     adenocarcinoma of the gastric-oesophageal junction.   "
193223|NCT00374998|"     This study examines two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers     to determine their safety and ability to induce a measurable immune response against malaria.   "
193224|NCT00375011|"     The three objectives of this trial are:        1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will          correlate with changes in CTP and MELD scores in patients with cirrhosis.        2. To determine the critical value of hepatic metabolic function as measured by BreathID          will predict which patients are at risk to develop complications of cirrhosis.        3. To determine the critical value of hepatic metabolic function as measured by BreathID          will predict which patients are at risk for liver related mortality.      The hypothesis is that the BreathID breath test will correlate to CTP and MELD scores, and     that thresholds can be established that will help predict risk of complications of cirrhosis     and mortality.   "
203113|NCT00505947|"     The purpose of this study is to determine if treatment with infliximab improves macular edema     which is refractory to laser photocoagulation in patients with diabetes.   "
193227|NCT00375050|"     The proposed study would evaluate the benefits of riluzole add-on treatment to patients with     schizophrenia who are already receiving medications, but still experience symptoms.     Neuroprotective medication riluzole is currently approved for treatment of amyotrophic     lateral sclerosis (Lou Gehrig's disease), a severe neurological illness. Due to its unique     mechanism of action, riluzole, if effective in helping the symptoms of schizophrenia, would     open novel directions in treatment of schizophrenia.   "
193228|NCT00375063|"     Unprotected left main coronary artery (ULMCA) stenting, offering restoration of a native flow     to left coronary artery, is the subject of intense investigations as a potential alternative     to bypass surgery. The purpose of the study is to compare the short and long term results of     unprotected left main stenting with coronary artery bypass surgery.   "
193229|NCT00375076|"     In a prospective, randomized, double-blind trial, the effects of two different dosages of     LMWH (5000 anti-Xa U od sc and 10 000 anti-Xa U od sc daily) on markers of hemostatic system     and thrombin generation will be investigated in non-surgical cancer patients will be     investigated.   "
193230|NCT00368459|"     This is a multisite pilot randomized trial of raloxifene or placebo for the treatment of     women with Alzheimer's disease.   "
193231|NCT00368472|"     The purpose of this study is to determine the safety of perampanel given as adjunctive,     long-term treatment in patients with refractory partial onset seizures.   "
193232|NCT00368485|"     The present study will use a new type of respirator in premature babies who need help with     their breathing. This new respirator uses signals from the baby's diaphragm - the most     important breathing muscle - to control the timing and the amount of air that the baby needs.     The goal of the study is to demonstrate that this new respirator can synchronize delivery of     air to the baby's efforts, and that synchrony is maintained regardless of whether the baby is     breathing with a tube or a mask.   "
193233|NCT00368498|"     The purpose of this study is to determine whether the standard dosage of teicoplanin is     adequate to produce timely the trough level > 10 mg/L, which is considered to be effective in     the treatment of methicillin-resistant Staphyllococcus aureus (MRSA) bacteremia.   "
193234|NCT00368511|"     We propose to obtain computerized dynamic posturography scores on patients in a     (psycho)geriatric nursing home utilizing the CAPS system from Vestibular Technology. This     instrument has been validated to measure human stability and is associated with a Fall     Probability percentage. Subjects will be asked to stand on a platform with eyes open and     closed for approximately 30 seconds. The data obtained will be utilized as a base for change     which can be compared to an outcome of music listening and fall prevention. Previous     investigations have demonstrated a decrease in fall rates associated with music listening. We     would like to measure the changes in human stability associated with a potential decrease in     fall rates. We would also like to use the history of falls of the tested individuals if     available. In case fall statistics are available we respectfully request access to all falls     data available from the involved geriatric nursing home . The falls data will be kept     confidential and only used as a control statistic in our evaluation of fall rates after     implementation of our applications. The music used will include Nolwenn Leroy, Mozart and     other Dutch and French Singers.   "
193235|NCT00368524|"     This randomized controlled trial examined whether an abbreviated treatment using abstinence     contingency management for housing and work/training (CM, n=103) with cocaine dependent,     non-psychotic, dually diagnosed homeless persons, would show non-inferior outcomes compared     to the full treatment (CM+, n=103). It was hypothesized that CM+ would show superior     abstinence and retention outcomes, but that CM, with components derived from previously     effective behavioral day treatment, would obtain non-inferior outcomes, defined as 75% or     more of those observed for the full treatment (CM+) during active treatment months 1-6. The     CM+ included all CM components but added behavioral day treatment that included voucher     reinforcement of $7.50-15.00, for objective weekly therapeutic goal attainment in five     domains of functioning: drug dependence, homelessness, unemployment, non-drug related     recreational activities, and behavioral, health, or mental health problems. Abstinence was     assessed by observed urine specimen collection and weekly testing weeks 1-52, and randomly,     bi-monthly for months 13-18. Abstinence, homelessness, employment and other outcomes were     also assessed at baseline, 2, 6, 12, and 18 months.   "
193236|NCT00368537|"     The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline     with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of     a complicated skin and/or skin structure infection (cSSSI).   "
193237|NCT00368550|"     The purpose of this study is to determine whether Sertraline, compared to placebo, is     effective in the treatment of alcohol dependence as a function of the subtype of alcoholic     patient being treated. This involved administering sertraline (to a maximum of 200 mg/day) or     an inactive placebo for a 14-week treatment period.   "
193238|NCT00368563|"     To evaluate the ability of 2 Helioblock SX Cream formulations to moisturize skin using     capacitance and transepidermal water loss methodology   "
193239|NCT00368576|"     The purpose of this study is to compare the effects of SB-480848 with placebo in subjects     with asthma.   "
193240|NCT00368589|"     A new way of scanning narrowing in the arteries (main blood vessels) caused by fatty deposits     known as plaques has been developed. Heart attacks and strokes occur when plaques become     inflamed, depending on the artery affected. Currently used clinical tests can only tell us     how much the vessel is blocked by the plaque and not how inflamed (i.e. dangerous) it is.     This new method of scanning using magnetic resonance imaging (MRI) and a special agent called     Sinerim can identify inflamed plaques. This study will evaluate patients with plaques in     their arteries in their neck at risk of strokes to see whether treatment with a     cholesterol-lowering drug called atorvastatin can reduce the amount of inflammation within     the artery wall within the first three months of treatment. If this effect can be measured     using MRI scanning with the use of Sinerim then the results of this study will provide     additional clinical validation of the use of MRI scanning combined with agents such as     Sinerem®.   "
193241|NCT00368602|"     The purpose of this study is to evaluate the efficacy and safety of treatment of chronic     cutaneous ulcers and burn wounds with topical beta adrenergic antagonists (Timoptic®).   "
193242|NCT00368615|"     The aim of this study is to study T-cells. Blood will be collected and the samples will be     used to generate T cell clones. Two separate blood draws will be required at the maximum.   "
193243|NCT00368628|"     New stroke therapies are needed. This study seeks to provide the preliminary data needed to     plan a future study that will evaluate the efficacy of using continuous positive airway     pressure (CPAP) to treat stroke patients who have sleep apnea. Our goal is to use this     therapy to reduce stroke symptom severity.   "
193244|NCT00368641|"     The objective of the study is to determine if the addition of peritoneal ultrafiltration to     standard therapy in treatment-resistant severe heart failure patients will improve fluid     balance and functional capacity such that they will spend less time in the hospital and have     an improved ambulatory quality of life in comparison to patients who remain on standard     therapy alone.   "
193245|NCT00368654|"     To evaluate whether a short-term course of methotrexate in patients treated with efalizumab     (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the     efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment     with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term     combination therapy of Raptiva and methotrexate.   "
193246|NCT00368667|"     The purpose of this study is to investigate the potential biological predispositions that     contribute to the difficulty patients with anorexia nervosa have in maintaining normal     weight.   "
193247|NCT00368680|"     The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup     of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this     group, without affecting mortality.   "
193248|NCT00368693|"     The purpose of this study is to test the efficacy and side effects, if any, of Dermal - LSR     combined with standard treatment. We hypothesize the treatment will provide beneficial     results for diabetic patients suffering foot ulcers.   "
193249|NCT00368706|"     To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects     with overactive bladder compared to tolterodine wmg, bid   "
193250|NCT00368719|"     To assess the long-term safety of tacrolimus ointment   "
193251|NCT00368732|"     Each year in the United States, thousands of babies are born with heart defects. Women who     take folic acid during pregnancy have a lower risk of giving birth to infants with heart     defects, but the reason for this remains unknown. This study will examine the relationship     between genes, nutrition, and the occurrence of heart defects in infants.   "
193252|NCT00368745|"     GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet     eligibility criteria will be randomized to receive pregabalin vs matching placebo while     simultaneously tapering off of alprazolam over 6 weeks. Subjects return weekly for assessment     of safety/tolerability of pregabalin vs placebo as well as for assessment of anxiety and     benzodiazepine withdrawal symptoms. Subjects successfully able to discontinue alprazolam,     will continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use).     The efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to     discontinue/remain free of alprazolam will be compared among pregabalin and placebo treated     groups. Hypothesis is that a greater proportion of subjects will be successful in     discontinuing and remaining free from benzodiazepines who were treated with pregabalin as     compared to subjects treated with placebo.   "
193253|NCT00368758|"     The purpose of the study is to establish an in-vitro method to evaluate the effect of     probiotics on gas production in feces (hydrogen and methane)   "
193254|NCT00368771|"     The purpose of this study is to assess the effect of participation in one of the following     interventions: (1) IBS Stress Management; (2) IBS Symptom Management; or (3) IBS Educational     Training on improving IBS associated symptoms. It is anticipated that this research will     provide information on the usefulness of psychological approaches in treating IBS and will     help scientists better understand the disorder.   "
193255|NCT00368784|"     This study is designed to identify the cells of the immune system that cause skin disease     such as psoriasis and mycosis fungoides. Blood samples from many patients will be compared in     hopes of finding common cells and molecules responsible for skin diseases. Results of this     study will increase our knowledge about immune mediated skin disease.   "
193256|NCT00368797|"     This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR     plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients     with severe Peripheral Arterial Occlusive Disease, Fontaine's stage IV. The efficacy was     assessed by the complete healing of at least one ulcer in the treated limb, 25 week     post-baseline and secondary by the rate of amputation and death.   "
193257|NCT00368810|"     This study will examine whether resistance to severe malaria is associated with weakening of     a specific immune response (TLR-mediated pro-inflammatory cytokine response). Some children     with mild malaria go on to develop severe disease, while others do not. The study will     analyze certain substances in the blood to try to determine what factors may protect against     severe malaria.      Healthy children and children 3 - 10 years of age with severe malaria who are being treated     at l'H pital Gabriel Toure in Mamako, Mali, West Africa, may be eligible for this study.     Participants have a mall sample of blood drawn from a vein and from two finger pricks.   "
193258|NCT00368823|"     Does presentation of clinical evidence for decision making at point-of-care improve     prescribing patterns in ambulatory pediatrics?   "
193259|NCT00368836|"     A pulmonary embolism (PE) is a blockage in one of the arteries of the lungs, and is usually     caused by a traveling blood clot. The D-dimer blood test is currently used to diagnose PEs,     but it is not always accurate for individuals who have recently undergone surgery or who have     inflammatory-provoking diseases. The purpose of this study is to evaluate the effectiveness     of the Carboximeter, a new PE diagnostic device that measures carbon dioxide (CO2) and oxygen     (O2) output, in individuals at risk for developing PEs.   "
193260|NCT00368849|"     The purpose of this research study is to evaluate the effect of atomoxetine (also known as     Strattera) compared to placebo (inactive substance) on daily activities such as attention and     focus, thinking ability and muscle movements in subjects with early Huntington Disease (HD)     and attention deficit disorder (ADD).   "
193261|NCT00368862|"     The aim of the present study was to examine the influence of memantine, a noncompetitive NMDA     receptor blocker, in depression co-morbid with long term alcohol heavy use comparing to     SSRI-inhibitor, escitalopram. Second goal is to compare their influence to cognitive tasks     and the third goal is to follow up alcohol-use with these two medicines.   "
193262|NCT00368875|"     This phase I/II trial is studying the side effects and best dose of vorinostat when given     together with paclitaxel and bevacizumab and to see how well they work in treating patients     with metastatic breast cancer and/or breast cancer that has recurred in the chest wall and     cannot be removed by surgery. Vorinostat may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor     growth in different ways. Some find tumor cells and kill them or carry tumor-killing     substances to them. Others interfere with the ability of tumor cells to grow and spread.     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.     Giving vorinostat together with paclitaxel and bevacizumab may kill more tumor cells.   "
193263|NCT00368888|"     To determine whether a new urine collection bag for infants produces a reliable urine sample     for culturing in respect of contamination rate with skin bacteria.   "
193264|NCT00368901|"     To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant     human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.   "
193265|NCT00368914|"     RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of sirolimus in     treating patients with metastatic or unresectable solid tumors.   "
193266|NCT00368927|"     This randomized phase II trial is studying sulindac to see how well it works compared to a     placebo in preventing lung cancer in current or former smokers with bronchial dysplasia.     Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming     back. The use of sulindac may prevent lung cancer from forming in patients with bronchial     dysplasia. It is not yet known whether sulindac is more effective than a placebo in     preventing lung cancer in patients with bronchial dysplasia.   "
193267|NCT00368940|"     This study will evaluate the efficacy of Problem Adaptation Therapy (PATH) vs. Supportive     Therapy for Cognitively Impaired (ST-CI) older adults in reducing depression and disability     in treating depressed, cognitively impaired older adults.   "
193268|NCT00368953|"     Revascularisation procedures such as percutaneous coronary intervention are associated with     overall worse outcomes in patients with diabetes mellitus. Implantation of coronary stents is     associated with higher restenosis rates compared to non-diabetic individuals.      There is only limited data available on the efficacy and safety of the novel Yukon Choice     drug-eluting stent system specifically in patients with diabetes mellitus. The trial will     determine the efficacy and safety of the novel Yukon Choice stent system compared to the well     established Taxus Liberté stent system. The primary endpoint will be in-stent late lumen     loss at 9 months as determined by invasive angiography.   "
193269|NCT00368966|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of a     13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given     concomitantly with routine pediatric vaccinations in Spain.   "
193270|NCT00368979|"     This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52     weeks to Benign Prostatic Hyperplasia (BPH) patients.   "
193271|NCT00368992|"     Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may stop     the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving cetuximab together with     paclitaxel, carboplatin, and bevacizumab may kill more tumor cells. This phase II trial is     studying how well giving cetuximab together with paclitaxel, carboplatin, and bevacizumab     works in treating patients with advanced non-small cell lung cancer   "
193272|NCT00369005|"     The purpose of this study was to determine whether restrictive guidelines for red blood cell     (RBC) transfusions for preterm infants can reduce the number of transfusions without adverse     consequences.   "
193273|NCT00369018|"     The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of     cervical precancerous lesions (dysplasia) in women that are referred for conisation     (surgery).   "
193274|NCT00369031|"     The purpose of this study is to determine whether an HIV vaccine given as three nasal     immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two     intramuscular immunisations with the same protein mixed with a liquid adjuvant, causes     untoward adverse reactions when administered to healthy adult volunteers. An initial     evaluation of immune responses to the vaccine will also be undertaken.   "
193275|NCT00369044|"     We designed this, randomized, double-blind, placebo-controlled trial to determine the     clinical efficacy of chronic administration of prednisone on renal function and clinical     status when added to standard care.   "
193276|NCT00369057|"     Our goal is to study the relationship between intraocular pressure during robotic     prostatectomy surgery and visual deficiencies/vision loss after surgery. We believe the risk     of vision loss from this surgery to be due to positioning during the operation, as well as     abdominal carbon dioxide insufflation. As robotic procedures are gaining in popularity, we     should determine whether they are subjecting this patient population, and perhaps more likely     the patient with a preoperative diagnosis of glaucoma, to an increased likelihood of     postoperative visual disturbance.If our hypothesis that intraocular pressure is increased in     these patients is confirmed, future studies will assess therapeutic modalities to maintain     the IOP near baseline.   "
193277|NCT00369070|"     The purpose of this study is to estimate the difference in objective response rates between     each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and paclitaxel/carboplatin plus     bevacizumab arm (Arm C) in subjects with advanced non-squamous NSCLC.   "
193278|NCT00369083|"     Aim of the study was to evaluate the efficacy of hospital-at-home treatment compared with     inpatient care in selected elderly patients with acute exacerbation of chronic obstructive     pulmonary disease (COPD).   "
193279|NCT00369096|"     The purpose of this study is to evaluate whether addition of bemiparin, once daily in     icodextrin solution for peritoneal dialysis for 16 weeks, increases the peritoneal capacity     for ultrafiltration and/or reduces creatinine transport in peritoneal dialysis patients     presenting functional disorders related to ultrafiltration deficit and/or high transport.   "
193280|NCT00369109|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This laboratory study is collecting skin biopsy specimens from patients receiving     irinotecan or gemcitabine for advanced solid tumors and using them to study change in DNA due     to this treatment.   "
193281|NCT00369122|"     This phase II trial is studying how well giving bevacizumab together with radiation therapy     and cisplatin works in treating patients with previously untreated locally advanced cervical     cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of     cervical cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy     x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving bevacizumab together with radiation therapy and cisplatin may kill more     tumor cells.   "
193282|NCT00369135|"     Sickness absenteeism caused by MSDs is a persistent and expensive health challenge in all     industrial countries including Switzerland. Despite much progress as to the cause and     prevention of MSDs, they continue to be some of the most prevalent and challenging health     problems with respect to the work-place and to socio-economic burden.      To improve the situation, several recent reviews recommended interventions based on the     bio-psycho-social model. Work-hardening and industrial rehabilitation programs focused more     on the in balance between physical and mental demands of work on one side and capacities of     the individual on the other side. Therefore we propose to merge the two models into one. The     result is an interdisciplinary intervention strategy witch includes work hardening, medical     trainings, a cognitive behavioural approach and work place intervention.   "
193283|NCT00369148|"     Combination therapy of glinides with premixed insulin provides better glycemic control than     premixed insulin alone.   "
193284|NCT00369161|"     This study is designed to evaluate whether tacrolimus dose reduction in de novo renal     recipients receiving everolimus can preserve renal function while maintaining efficacy.   "
193285|NCT00369174|"     This phase II trial is studying how well rosiglitazone works in preventing oral cancer in     patients with oral leukoplakia. Chemoprevention is the use of certain drugs to keep cancer     from forming, growing, or coming back. The use of rosiglitazone may keep cancer from forming     in patients with oral leukoplakia   "
193286|NCT00369187|"     This Phase IV, dose escalation, within-patient controlled study of pharmacokinetics (PK),     safety and tolerability compares a single dose administration of a large protein molecule     without recombinant human hyaluronidase (rHuPH20) to a single dose administration of the     large molecule with escalating doses of rHuPH20. The study hypothesizes that an optimal dose     of rHuPH20 will increase the bioavailability of large molecule drug administration.   "
193287|NCT00369200|"     This phase I trial is studying the side effects and best dose of AFP464 in treating patients     with advanced solid tumors. Drugs used in chemotherapy, such as AFP464, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.   "
193288|NCT00369213|"     This RCT compares the clinical and non clinical condom failure rate among condom using     heterosexual couples with and without externally applied additional spermicidal lubricant.     The hypothesis is that breakage and slippage rates will be reduced.   "
193289|NCT00369226|"     The purpose of this study is to determine if Velcade (also known as bortezomib) can help     prevent graft versus host disease (GVHD) developing after transplantation. This is done by     using a combination of three immune suppressive medications: Velcade, tacrolimus and     methotrexate. Stem cell transplantation is one of the options for patients with cancer of the     blood or blood forming organs. Recently, allogeneic stem cell transplants have been performed     using lower doses of chemotherapy and radiotherapy: non-myeloablative or mini transplants.     GVHD is a significant problem that may occur even after mini transplantations. Information     from other research studies, suggests that Velcade may help to reduce the risk of developing     GVHD when given early after transplantation.   "
193290|NCT00369239|"     The purpose of this research study is to see how well patients in an early phase of their     illness respond to treatment and whether this depends on how well they functioned socially,     academically and vocationally before becoming ill. The study also examines whether patients     with more insight into their illness have better outcomes.   "
193291|NCT00369252|"     This is a phase I trial of nimotuzumab that will be conducted in patients with advanced     incurable solid tumors. This is a dose-seeking study to determine the maximum tolerated and     recommended phase II doses of nimotuzumab that can be safely given to patients with advanced     and/or metastatic solid tumors.   "
193292|NCT00369265|"     The purpose of this study is to determine whether Lansoprazole 30mg taken twice daily is     effective in the treatment of laryngitis due to gastroesophageal reflux.   "
193293|NCT00369278|"     This study will assess the association of an initially intensified dosing regimen of     enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal     transplantation with acute rejections relative to the rapid achievement of an MPA     (mycophenolic acid) exposure of ≥ 40 mg*h/L compared to a standard dosing regimen of EC-MPS.     Additionally, this study will assess safety and tolerability of the intensified dosing     regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).   "
193294|NCT00369291|"     RATIONALE: Giving CpG 7909 after an autologous stem cell transplant may make a stronger     immune response and prevent or delay the recurrence of cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of CpG 7909 in     treating patients who have undergone autologous stem cell transplant.   "
193428|NCT00376701|"     The primary purpose of the study is to investigate whether patients with Choroidal     Neovascularization secondary to Age-related Macular Degeneration, receiving triple or double     therapy compared to monotherapy with Avastin will reduce the intervention rate with     equivalent safety and efficacy.   "
193295|NCT00369304|"     This is an open-label, randomized, 2-period crossover, inpatient study to be performed in     healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel     cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or     AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will     be administered after an overnight fast of at least 10 hours.   "
193296|NCT00369317|"     This phase III trial is studying how well combination chemotherapy works in treating young     patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugs     used in chemotherapy work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving more than one drug (combination     chemotherapy) may kill more cancer cells.   "
193297|NCT00369330|"     To investigate if in acute symptomatic atrial fibrillation (AF) the early (>2 hrs but within     12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer     recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the     beginning of the arrhythmia) within the first 3 months after cardioversion.   "
193298|NCT00369343|"     Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine     reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied     in the development program for the treatment of major depressive disorder (MDD), for     vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral     diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will     investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri-     and postmenopausal.   "
193299|NCT00369356|"     The possibility of using the new drug eluting stents (DES) technology has significantly     changed the mid-term outcome of percutaneous coronary interventions (PCI) in terms of reduced     recurrence of angina. The way interventionalists accomplish their work is changing     accordingly, with a strong trend to a wider use of DES and a consequent perceived patients'     clinical benefit.      Evidences supporting the superiority of DES in reducing ischemic recurrence after PCI     compared to traditional stents (BMS) are available from randomized studies. A recent     meta-analyses underlines that:      DES are superior to BMS in reducing clinical recurrence of ischemia, DES and BMS offer     identical results in terms of death and infarction, Rapamycin and paclitaxel DES offer     similar results.      The aim of our study is to perform a multicenter, randomized study to assess the clinical     efficacy and safety of the oral prednisone therapy after PCI as a possible systemic     alternative to currently available BMS and DES. Furthermore, the study aims at analyzing the     clinical outcome of the commercially available DES in the context of an independent research     and a cost-benefit comparison with BMS and oral steroids.   "
193300|NCT00369382|"     The primary purpose of this study is to determine whether converting from calcineurin     inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing     calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients     with mild to moderate renal dysfunction.   "
193301|NCT00369395|"     This is a Phase 2, multicenter, research study determining the effects of an investigational     drug called volociximab in metastatic melanoma.      The purpose of the study is to compare the clinical benefit and safety of volociximab.     Pharmacokinetics and mechanism of action will also be evaluated.   "
193302|NCT00369408|"     The purpose of this study is to determine whether naltrexone, combined with brief coping     skills therapy, is effective in the treatment of heavy drinking.   "
193303|NCT00369421|"     Researchers intend on diagnosing and treating certain inborn errors of metabolism. By doing     this researchers hope to expand their knowledge about these disorders and provide access to     patients of interest for research, teaching, and clinical experience.      Patients participating in this study will be examined and treated on an out patient basis, if     practical. However, patients requiring specialized tests or treatments will be admitted to     the NIH Clinical Center as necessary. Researchers will use only accepted medical procedures     in diagnosing (medical history, physical examinations, X-ray studies, eye examinations, blood     tests, and urine tests) and treating the patients involved in this study. Additional tests     may be required on a case to case basis.      Many patients seen in this study will go on to be enrolled in a specific disease-related     research study.<TAB>   "
193304|NCT00369434|"     The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS     SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the     treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of     postmenopausal women.   "
193305|NCT00369447|"     This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination     with external radiation in patients with non-small cell lung cancer. The purpose of the Phase     I portion of the study is to evaluate the safety and feasibility of the administration of     nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy and     to select the optimal dose for the Phase II component of the study. The primary objective for     the Phase II portion of the study is to examine the efficacy of this combination treatment.      The Phase I component of this study has been completed. The Phase II is now closed to     recruitment.   "
193306|NCT00369460|"     RATIONALE: Measuring changes in muscle tissue in patients with cancer may help doctors     predict how well patients will respond to treatment, and may help the study of cancer in the     future.      PURPOSE: This pilot study is evaluating changes in muscle tissue in patients with pancreatic     cancer.   "
193307|NCT00369473|"     The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA   "
193317|NCT00369616|"     The purpose of this study is to help smokers quitting by vaccinating them with CYT002-NicQb.     Upon vaccination, the smoker will generate antibodies directed against free nicotine. The     antibodies will bind nicotine and prevent its passage into the brain. The successfully     vaccinated smoker will have no reward effect after smoking, thus braking the vicious circle     of nicotine addiction.   "
193352|NCT00375700|"     In this study, an oral nutrition supplement has been developed that take into consideration:     the nutritional requirements, treatment side-effects and taste preferences of head and neck     cancer patients; the acceptance of a supplement when experiencing radiation therapy     side-effects; and the taste preferences of head and neck cancer patients which may affect the     supplement intake. We hope to increase dietary intake during the last 2 weeks of radiation     therapy.   "
193308|NCT00369486|"     The study involves the enrollment of patients over 18 years of age with diabetic macular     edema involving the center of the macula who have not already been given maximal laser     treatment.      Patients with one study eye will be randomly assigned (stratified by prior laser) with equal     probability to one of five treatment groups:        1. Focal laser photocoagulation (modified ETDRS technique)        2. Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)        3. Anterior peribulbar injection of 20 mg triamcinolone        4. Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser        5. Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser      For patients with two study eyes (both eyes eligible at the time of randomization), the right     eye (stratified by prior laser) will be randomly assigned with equal probabilities to one of     the five treatment groups listed above. If the right eye was assigned to laser only, then the     left eye will be assigned to one of the four triamcinolone groups above with equal     probability (stratified by prior laser). If the right eye was assigned to receive     triamcinolone, then the left eye will receive laser only.      Triamcinolone acetonide will be the corticosteroid utilized in this study. The triamcinolone     acetonide preparation to be used is Kenalog. Kenalog is manufactured by Bristol Myers Squibb     and is approved by the Food and Drug Administration for intramuscular use for a variety of     indications. Peribulbar injections of Kenalog have been used for a wide variety of ocular     conditions, particularly uveitis and post-cataract extraction cystoid macular edema, for many     years.      Two different triamcinolone regimens will be assessed in the study: 40 mg injected     posteriorly and 20 mg injected anteriorly. There is no indication of which treatment regimen     will be better. Although the injection behind the eye is more common than the injection near     the front of the eye, the injection near the front of the eye has less risk of injuring the     eye. However, it is possible that the injection near the front of the eye may increase eye     pressure more frequently. Little is known about which of the two injections decreases macular     edema and improves vision more often.      Patients enrolled into the study will be followed for three years and will have study visits     1 month, 2 months, 4 months, 8 months and annually after receiving their assigned study     treatment. For the first 8 months of the study, patients should only be retreated with their     randomized treatment. However, if the patient's visual acuity has decreased by 15 letters or     more, then any treatment may be given at the investigator's discretion. After completion of     the 8-month visit, treatment is at investigator discretion.      The primary objective of this study is to obtain estimates of efficacy and safety outcomes     for each of the treatment groups. These estimates will provide a basis for the sample size     estimation and hypothesis generation in a phase III trial.   "
193309|NCT00369499|"     The primary objective of this Study is to compare the effect of transcatheter device closure     of atrial shunting to a non-closure control group over a period from cessation of procedure     related medication at 3 months until 9 months post randomization by determining the     proportion of patients that experience a 50% or more reduction in the baseline monthly     migraine attack frequency in each group.   "
193310|NCT00369512|"     This is a phase II study designed to study the effectiveness of combined radiotherapy and     erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk     for recurrence. Participants enrolled in the study will be evaluated by a head and neck     surgeon, and a radiation oncologist. Whenever possible, a preoperative biopsy will be     performed after participant enrollment in the study for histological confirmation and for     molecular correlates. Participants enrolled prior to surgical resection will begin erlotinib     at 150 mg by mouth (PO) every day (QD) (14 tablets) to be taken 14 days prior to surgical     resection. Following planned surgical resection, the participant will begin Erlotinib therapy     and radiotherapy at the same time and within 4-8 weeks of the surgical resection.   "
193311|NCT00369538|"     Chronic glomerular diseases are one of the main causes leading to end stage renal disease     (ESRD). Hypertension and proteinuria are two modifiable factors promoting the progression of     ESRD. Podocyte are terminally differentiated epithelial cells and play a central role in the     progression of chronic kidney disease and in the development of glomerulosclerosis. The     presence of podocyte in urines (podocyturia) has been documented by several teams with     continuous and regular podocyturia during glomerular disease. This facts suggests that     podocyturia could become a marker of podocyte loss and glomerular damage. In our university     hospital, we developed a technique to evaluate the number of microparticles (cellular     fragments) in different biologic samples. The podocytary origin of microparticles will be     determinated thanks to specific antibodies. The aim of the present study is: i) to quantify     podocyturia during glomerular nephropathies by dosing podocyte microparticles ii) to study     the relationship between podocyturia and other biologic markers such as proteinuria iii) to     evaluate the effect of angiotensine 2 blockage on podocyturia. This is an open-labelled     randomized monocenter cross-over study. Twenty subjects with hypertension and glomerular     nephropathy characterized by proteinuria and a normal or slightly altered renal function will     be included. Patients will be treated successively by an angiotensin receptor blocker (ARB),     losartan and by a thiazide, hydrochlorothiazide, (after a wash out period). We will study the     impact of these two therapies on podocyturia. Results will be compared with others markers     like proteinuria (and its selectivity). We may finally dispose of a non invasive urinary     marker of podocyte lesions responsible for glomerulosclerosis and for ESRD progression.     Moreover mechanism of nephroprotection of the ARB may be more comprehensive.   "
193312|NCT00369551|"     This phase I trial studies how well giving bevacizumab together with paclitaxel, carboplatin,     and radiation therapy to the chest works in treating patients with locally advanced non-small     cell lung cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving bevacizumab together with paclitaxel,     carboplatin, and radiation therapy may kill more tumor cells.   "
193313|NCT00369564|"     RATIONALE: Glutamic acid may help lessen or prevent nerve damage caused by vincristine. It is     not yet known whether glutamic acid is more effective than a placebo in preventing nerve     damage in patients receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute     lymphoblastic leukemia, or non-Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying glutamic acid to see how well it works     compared to a placebo in reducing nerve damage caused by vincristine in young patients     receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or     non-Hodgkin's lymphoma.   "
193314|NCT00369577|"     The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the     treatment of acute agitation in schizophrenic patients. The study will be conducted in 120     agitated schizophrenic patients - either newly admitted to a hospital setting or a research     unit for acute agitation or already in hospital for chronic underlying conditions. Patients     meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to     Staccato Placebo. Following administration of study drug, assessment of agitation state will     be conducted at serial time points using standard agitation scales over a 24 hour period.   "
193315|NCT00369590|"     This phase II trial is studying how well VEGF Trap works in treating patients with recurrent     malignant or anaplastic gliomas that did not respond to temozolomide. VEGF Trap may stop the     growth of malignant or anaplastic gliomas by blocking blood flow to the tumor.   "
193316|NCT00369603|"     The purpose of this study is to determine whether standard medications approved for     Alzheimer's disease treatment differ in their action on brain functioning and whether any     observed brain activity differences as result of treatment are associated with particular     patterns of dementia improvement or reduced decline.   "
193350|NCT00375674|"     To compare the disease free survival time and safety of sunitinib with placebo in adjuvant     treatment patients at high risk of recurrent kidney cancer after surgery.   "
193318|NCT00369629|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Giving gemcitabine together with pemetrexed disodium may kill more     cancer cells.      PURPOSE: This was planned as a phase I/II trial studying the side effects and determining the     best dose of gemcitabine hydrochloride when given together with pemetrexed disodium.     Unfortunately, due to a lack of funding, the phase II portion was never conducted.   "
193319|NCT00369642|"     Pediatric obsessive-compulsive disorder (OCD) is a chronic and often disabling illness with     an estimated lifetime prevalence of 1 to 3%. Pediatric OCD is associated with significant     social, educational, and familial impairment, as well as comorbid emotional and behavioral     disturbances that serve to complicate the prognosis of the illness and treatment outcome.     While limited open treatment trials and one controlled trial have demonstrated     cognitive-behavioral therapy (CBT) to be effective for pediatric OCD, controlled trials are     lacking in the literature. There are a number of incremental benefits that an intensive     program for OCD may offer. First, existing outpatient interventions typically achieve     treatment gains over a 15 to 20 week period. The present program typically lasts between 2 to     4 weeks, and thus may present as a more timely, cost-effective, and efficient means of     treatment for some individuals. Second, given that many children and adolescents may not have     access to mental health professionals who are trained in empirically grounded interventions     for OCD, the present treatment setting allows youth to receive appropriate, state of the art     care. Finally, evidence suggests that daily CBT may be particularly effective in treating     children who have been refractory to prior treatments (e.g., medication or once per week     CBT). Prior to treatment, all consenting families will be randomly assigned to either the     treatment condition or a three-week wait-list control condition. Those families randomized to     the wait-list condition will receive treatment immediately after the three weeks are     completed. The treatment group will be administered all measures immediately before     treatment, immediately after treatment, and three months after treatment. The wait-list     control condition will be administered all measures upon starting the wait-list period,     immediately following the conclusion of the three-week wait-list period, and after the     treatment program has finished. The purpose of the current study is to evaluate the efficacy     of daily cognitive-behavioral treatment for pediatric OCD.   "
193320|NCT00369655|"     This phase II trial is studying how well VEGF Trap works in treating patients with metastatic     breast cancer. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the     tumor   "
193321|NCT00369668|"     The purpose of this study was to determine the effect of two amounts of treatment therapy on     post stroke motor recovery in the arms. The therapy is bilateral movement training combined     with electrical stimulation on the impaired limb.   "
193322|NCT00375089|"     Prader-Willi syndrome (PWS) is a rare genetic disorder that affects about 1 in 14,000 people     in the United States. As the most commonly identified genetic cause of obesity, PWS is often     confused with Early-onset Morbid Obesity (EMO). Individuals with EMO show some signs of PWS,     but clinically do not have PWS. The purpose of this study is to evaluate the clinical     features and genetic basis of PWS and EMO, and to determine how these conditions affect a     person throughout a lifetime.   "
193323|NCT00375102|"     This one-year pilot study has two specific aims: 1. to determine the feasibility of     conducting a randomized controlled trial of acupuncture and the relaxation response for     substance abuse among homeless veterans who are in a domiciliary care program, and 2. to     collect and analyze pilot data to estimate the effect size for planning a future larger study     to fully test the hypothesis of the effectiveness of acupuncture and the RR in reducing     cravings for substances (alcohol and drugs), and the corollary effects on quality of life.   "
193324|NCT00375115|"     The trial will examine the efficacy of sambucol in the treatment of influenza. The primary     efficacy endpoint will be the length of time to resolution of influenza illness.The double     blind trial will be conducted at the Personnel Clinic, and at the Clinical virology Unit,     Hadassah University Hospital, and will include 100 patients with laboratory-confirmed     influenza infection, 50 in the sambucol and 50 in the placebo study arm.   "
193325|NCT00375128|"     This study examines the ability of two new malaria vaccines (FP9-PP and MVA-PP) to prevent     the development of malaria infection after controlled exposure to the parasite. Volunteers     for this trial will have received these vaccines in the preceding trial VAC027.1.   "
193326|NCT00375141|"     The purpose of the trial is to compare clinical efficacy and occurrence of side effects in     the treatment of photodamaged skin with Pulsed Dye Laser and Intense Pulsed Light.   "
193327|NCT00375154|"     The purpose of this study is determine if NPPV can be performed in a pre-hospital setting     very early after onset of dyspnea with a similar benefit in need of intubation and mortality     as in previous study in hospital context and if early NPPV intervention have a real, rather     standard medical therapy, value, both on objectively measured parameters and on patient's     clinical status.   "
193328|NCT00375167|"     The present study will determine if Spaniol and colleague's (1994) Recovery Workbook group     intervention is an effective clinical tool to move a person with SMI along in their journey     of recovery. The primary outcome measurements of this study will be the participants'     perceived level of empowerment, hope and optimism, knowledge of recovery, and life     satisfaction. This kind of information would add to the current body of knowledge about how     principles of recovery can be used in psychoeducational programs used by outpatient community     mental health services.   "
193329|NCT00375180|"     The investigators hope to learn more about how side-effects of RT or RTchemo affect food     intake and nutrition status.   "
193330|NCT00375193|"     The purpose of the study is to evaluate the objective tumor response rate of amrubicin when     administered as second-line therapy to ED-SCLC patients who have refractory or progressive     disease.   "
193331|NCT00375206|"     The purpose of this study is to evaluate how well the vaccine is tolerated at sites where     administrations are given and any effects it may have on subjects' wellbeing. The study will     also test the ability of vaccine to cause particular immune responses in the body.   "
193332|NCT00375219|"     To evaluate the safety and efficacy of subcutaneous administration of omacetaxine     mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated,     or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene     mutation.   "
193333|NCT00375232|"     The purpose of this study is to determine if treatment of exercise-induced Bronchospasm with     montelukast will help college athletes train more effectively and thus become more     competitive in a non ergogenic manner.   "
193334|NCT00375245|"     The purpose of this study is to determine the highest safe dose of rapamycin when given with     a fixed amount of grapefruit juice.   "
193351|NCT00375687|"     The purpose of this study is to determine whether early hormonotherapy is effective in the     treatment of high risk prostate cancer patients after radical prostatectomy.   "
193335|NCT00375258|"     CRASH 2 is a large pragmatic randomised placebo controlled trial of the effects of the early     administration of the antifibrinolytic agent tranexamic acid on death, vascular events and     transfusion requirements. Adults with trauma who are within 8 hours of injury and have either     significant haemorrhage, or who are considered to be at risk of significant haemorrhage, are     eligible if the responsible doctor is for any reason substantially uncertain whether or not     to use an antifibrinolytic agent. Numbered drug or placebo packs will be available in each     participating emergency department. Randomisation will involve calling a 24-hour freecall     randomisation service. The call should last only a minute or two and at the end of it the     randomisation service will specify which numbered treatment pack to use. For hospitals where     telephone randomisation is not feasible, randomisation will be by taking the next     consecutively numbered treatment pack. No extra tests are required but a short form must be     completed one month later or on discharge or on death (whichever occurs first).   "
193336|NCT00375271|"     The aim of this study is to evaluate different strategies of hemodynamic optimization in high     risk surgical patients during the first twelve postoperative hours in ICU based on a protocol     guided by a less invasive monitorig tool (Vigileo®), oriented by a fiberoptic central venous     catheter that allows continuous monitorig of SvcO2 (PreSep®), and a pressure transducer     (FloTrac®) that allows cardiac output calculation by the standard deviation of mean arterial     pressure or a standard resuscitation strategy.   "
193337|NCT00375284|"     This trial is a 6-week, double-blind, randomized, active and placebo-controlled     parallel-group study with a primary objective of comparison of starting doses of pramipexole     fixed-dose (0.25 mg daily) and pramipexole titrated-dose (0.125 mg qd for 1 week, then 0.25     mg qd for the remaining 5 weeks) with placebo to evaluate efficacy and safety in treating RLS     symptoms in patients diagnosed with idiopathic RLS.      The secondary objectives of this study will be to assess the onset of action of symptomatic     relief of RLS for pramipexole with daily assessment of PGI and modified IRLS during two     intervals of the first 2 weeks (Days 2, 3 and 4 and Days 9, 10, and 11) and assessment of     IRLS, PGI and CGI-I at Weeks 1, 2, 4 and 6 (CGI-I additionally on Day 3).   "
193338|NCT00375297|"     This prospective double-blind, placebo-controlled (DBPC) study, assessed the efficacy of     sildenafil in women with serotonin reuptake inhibitor antidepressant-associated sexual     dysfunction (SRI-AASD) following the same protocol which previously established efficacy in     men with SRI-AASD.   "
193339|NCT00375310|"     The purpose of this study is to evaluate the safety and tolerability of the combined     treatment of Sorafenib (BAY 43-9006) with Gemcitabine and radiotherapy in patients with     localized unresectable pancreatic cancer.   "
193340|NCT00375323|"     The purpose of the study is to compare the effects of recombinant factor VIIa (NovoSeven) on     restoring coagulation activation between patients with hemophilia A and antibodies to factor     VIII and normal subjects (controls) by use of an in vivo method.   "
193341|NCT00375336|"     The purpose of this study is        -  to determine the degree of endothelial dysfunction and inflammation in calcific aortic          valve disease associated with coronary artery disease(CAD).        -  to determine whether there is relationship between calcium metabolism and calcific          aortic valve disease associated with CAD.   "
193342|NCT00375349|"     Aim:        1. To determine the prevalence of fatty liver in a cohort of patients hospitalized with          chest pain in the Cardiology department.        2. To assess the effect of statins on the prevalence of fatty liver by a cross sectional          survey of patients hospitalized with chest pain.   "
193343|NCT00375362|"     Patients who undergo general anestheesia for total knee arthroplasty pften have sever     postoperative pain which hinders their rehabilitation. Nitroglycerin patches have been found     to cause alleviation of pain especially when used in conjuction with morphine. Therefore we     propose placement of a nitroglycerin patch after total kneee arthroplasty surgery and see how     it affects pain scores or causes less nedd for morphine after surgery.   "
193344|NCT00375375|"     Minimal hepatic encephalopathy (MHE) has a negative effect on patients’ daily functioning. No     study has so far investigated the effect of treatment related improvement in cognitive     functions on health related quality-of-life (HRQOL). This study was carried out to determine     the influence of treatment on psychomotor performance and on HRQOL in patients with MHE.      The mean number of abnormal NP tests decreased significantly in patients in treated group     compared with patients in untreated group MANOVA for time and treatment, P =.001). Mean total     SIP score improved among patients in the treated group after 3 months compared with patients     in untreated group after 3 months (MANOVA for time and treatment, P=.002). Improvement in     HRQOL was related to the improvement in psychometry. In conclusion, treatment with lactulose     improves both cognitive functions and HRQOL in cirrhotic patients with MHE.   "
193345|NCT00375388|"     The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to     investigate the effects of metformin HCL in patients with type 2 diabetes mellitus     intensively treated with insulin on the quality of the metabolic control of diabetes, the     daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of     microvascular and macrovascular complications, and on the qualify of life (Diabetes Health     Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.   "
193346|NCT00375401|"     The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in     obese adults   "
193347|NCT00375414|"     Peristomal infections are the commonest complications of PEG despite prophylactic antibiotics     which may result in emergence of resistant micro-organisms like Methicillin resistant     Staphylococcus aureus (MRSA). Introducer PEG technique avoids the sojourn of PEG catheter     through the oropharynx so chances of infectious complications are negligible. It was not     popular because of associated risks and complications. However the new introducer PEG     gastropexy has been recently proved to be safe. To determine the incidence of peristomal     wound infections during the immediate 7 day post procedure follow up period after the new     introducer PEG gastropexy   "
193348|NCT00375648|"     This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered     intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients     with prostate cancer.   "
193349|NCT00375661|"     The purpose of this study is to determine whether low-dose peg-interferon plus ribavirin     therapy is effective in the prevention of hepatocellular carcinoma (HCC) in patients who had     the curative resection of primary HCC.   "
193353|NCT00375713|"     Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder     rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the     2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from     dermatitis and eczema with pruritus symptoms   "
193354|NCT00375726|"     Dengue fever, caused by dengue viruses, is a major health problem in the tropical and     subtropical regions of the world. The purpose of this study is to test the safety of and     immune response to a new dengue virus vaccine in healthy adults.   "
193355|NCT00375739|"     The purpose of this study is to determine whether topical application of PEP005 is safe for     the treatment of actinic keratoses.   "
193356|NCT00375752|"     This study will evaluate the safety/efficacy of zoledronic acid when given by intravenous     infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal     patients with hormone responsive breast cancer   "
193357|NCT00375765|"     Dutasteride is used in the treatment of benign prostate enlargement (BPH).It inhibits     conversion of testosterone (T) into the more potent dihydrotestosterone (DHT) to stop     prostate (and possibly prostate cancer) growth. DHT regulates the expression of certain genes     in the prostate. The pharmacodynamics of DHT reduction in the prostate were never     investigated until now, as every measurement would require prostate tissue retrieval, which     is medically and ethically unacceptable. A recently developed test is able to quantitatively     measure gene expression in prostate-borne cells, in urine sediments after prostate massage.     By measuring this gene expression in patients using dutasteride, it has become possible to     assess the pharmacodynamics of gene expression reduction, which is representative for the     pharmacodynamics of DHT reduction. Repeated prostate tissue sampling has therefore become     unnecessary. This newly gained knowledge will lead to a better understanding of the action of     dutasteride and will possibly help improve treatment of symptomatic BPH (Benign Prostatic     Hyperplasia) and PrCa (Prostate Cancer)in the future.   "
193358|NCT00375778|"     Purpose of study: To investigate whether the NMDA antagonist Memantine has a substantial     effect of brain metabolism in patients with Parkinson's disease (PD), using Positron Emission     Tomography (PET).      Background: Disturbances in brain metabolism is thought to contribute to degeneration of     neurons in brain of PD patients. Production of toxic oxygen radicals and presence of too much     excitatory neurotransmitter (glutamate) due to over activity is involved. These factors can     theoretically be alleviated by memantine.      Hypothesis: Memantine decreases metabolism in areas in PD brain known to be over-active.     Decreases in cerebral blood flow and oxygen metabolism in these areas will be the consequence     and this can be detected by PET.   "
193359|NCT00375791|"     This is a phase 2 study of perifosine in patients with multiple myeloma. Patients will     receive perifosine 150 mg at bedtime (qhs) daily. Patients will be assessed by serum and/or     urine-electrophoresis at least every 3 weeks.   "
193360|NCT00375804|"     The objectives for this study:        1. Investigate some of the causes for the racial disparity of endometrial cancer survival          rates among black and white women        2. Examine the biologic correlates of aggressive behavior such as estrogen receptor status,          p53 and HER-2/neu overexpression, and aromatase activity   "
193361|NCT00375817|"     To assess the efficacy and safety of MyoCell therapy on myocardial function in congestive     heart failure patients, post-myocardial infarction   "
193362|NCT00375830|"     This clinical trial studies sodium fluorine-18 (18F NaF)/fluorine-18 (18F) fluorodeoxyglucose     (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) in detecting     skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate     cancer. 18F NaF and 18F FDG are radioactive substances that are absorbed by cancerous cells     and allow for the cancer to be found using diagnostic procedures such as PET/MRI. PET/MRI is     a procedure that combines detailed pictures of areas inside the body from PET and MRI scans     and may help find and diagnose skeletal metastases in patients with breast or prostate     cancer. It is not yet known whether 18F NaF/18F FDG PET/MRI is better than standard imaging     methods in detecting skeletal metastases.   "
193363|NCT00375843|"     This study will examine how brain activity is affected by antidepressant treatment and how     changes in brain activity relate to treatment response in people with depression.   "
193364|NCT00375856|"     Primary Research Questions:        1. Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a          Sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e.          quality of life, function, range of motion) than similar patients who undergo total knee          arthroplasty (TKA) using the Sigma fixed bearing knee?        2. Do patients with knee OA who undergo TKA with a Sigma rotating platform have different          knee kinetics and kinematics as measured by gait analysis than similar patients who          undergo TKA using the Sigma fixed bearing knee?        3. Do patients with knee OA who undergo TKA with or without computer assistance have better          clinical outcomes at two years following surgery (quality of life, function, range of          motion)?        4. Do patients with knee OA who undergo TKA with or without computer assistance have          different knee kinematics and kinetics as measured by gait analysis?   "
193365|NCT00375869|"     The purpose of this study is to see if the treatment of severely brain injured patients with     darbepoetin (a long acting form of erythropoietin) will be safe, and will reduce brain damage     by decreasing harmful levels of chemicals in the brain.   "
193366|NCT00375882|"     Hypothesis: Mild Hypothermia has a protective effect on residual hearing of patients     undergoing cochlear implantation   "
193367|NCT00375895|"     In France, 50% of hepatitis C virus carriers develop chronic clinical hepatitis, which may     lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is     constant after transplantation and recurrence causes chronic liver disease in 50 to 80% of     cases. The aim of this study is to assess the efficacy of cyclosporin on C virological     response. Patients included in the Transpeg 1 study and non-responder or with a recurrent     disease will be switched from their tacrolimus therapy to cyclosporin, in association with a     1 year peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the     percentage of patients with a negative qualitative PCR after 19 months of cyclosporin     treatment.   "
193486|NCT00377468|"     The purpose of this study is to determine whether application of low dose     Delta9-Tetrahydrocannabinol can prevent the development of chronic pain in patients with     acute CRPS.   "
193368|NCT00375908|"     The investigators propose to compare the proteomic analysis of umbilical venous blood from     neonates with brain injury to gestational age matched noninjured controls. After delivery an     umbilical arterial gas and a 10 ml umbilical venous sample are obtained, then the remainder     of the cord blood is discarded. The investigators plan to use this cord blood that would     otherwise be discarded to perform our proteomic analysis. The investigators will use up to 20     ml of cord blood per delivery. This will be a 5 year study during which time the     investigators hope to analyze 450 infants at Johns Hopkins Hospital and Bayview Medical     Center. The investigators will obtain an umbilical venous sample from infants born at < 34     weeks gestation. For infants born at > 34 weeks the investigators will obtain an umbilical     venous sample for any infant suspected to be at risk for neurologic injury by having a     diagnosis of chorioamnionitis during labor, nonreassuring fetal heart rate tracing at the     time of delivery, or a 5 minute Apgar < 7. For the infants born at < 34 weeks the brain     injured infants will be compared to gestational age matched controls without brain injury.     For the infants born at > 34 weeks, each infant later confirmed to have neurologic morbidity     will be compared to a gestational age matched noninjured control. The investigators hope to     use proteomic analysis to determine if there are measurable differences in protein expression     between the 2 groups.   "
193369|NCT00375921|"     Changes to taste and smell have been reported in head and neck cancer patients who undergo     radiation and chemotherapy. This may cause food to be unappealing and can lead to a reduced     food intake. Thsi study will increase our understanding of taste and smell changes and how it     relates to food and taste preferences.   "
193370|NCT00375934|"     A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain     following bunionectomy surgery.   "
193371|NCT00375947|"     Participants in this study will do hand exercises once per day for 16 weeks. The purpose of     the study is to determine if hand exercises designed to improve range of movement and     strength are an effective way to decrease functional limitations for people with hand     osteoarthritis. The study will also attempt to determine if pain and stiffness are improved,     and if hand strength and dexterity are improved.   "
193372|NCT00375960|"     The objective of this study is to investigate the safety and efficacy of an investigational     drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's     feet and legs, or even in one's hands and arms, sometimes experienced by people with     diabetes). An investigational drug is one that is not approved by the United States Food and     Drug Administration (FDA) and/or Health Canada.   "
193373|NCT00375973|"     The purpose of this study is to determine the safety and efficacy of duloxetine compared with     placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).   "
193374|NCT00375986|"     The purpose of this study is to determine if there are differences in operative blood loss     with manual vs. spontaneous removal of the placenta during cesarean section.   "
193375|NCT00375999|"     1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric     cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic     chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the     Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response     3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1     as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks.     4.Primary endpoints:        1. Efficacy:overall response rate according to the Response Evaluation Criteria in Solid          Tumors criteria, time to response, duration of response, and time to treatment failure.        2. Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity          Criteria for Adverse Effects (version 3.0).   "
193376|NCT00376012|"     Title: Randomized clinical trial to assess the efficacy of short course intermittent regimens     for the treatment of HIV-associated tuberculosis      Phase: Phase III trial      Population: 300 HIV positive patients with tuberculosis.      Number of Sites:Four        1. Tuberculosis Research Centre, Chennai        2. Government General Hospital, Chennai        3. Government Hospital of Thoracic Medicine, Tambaram        4. Government Rajaji Hospital, Madurai      Study Duration:36 months      Study Objective:To study the efficacy of the standard RNTCP Category I regimen (2EHRZ3 /     4RH3) the control arm vs. an extended continuation phase regimen 2EHRZ3 / 7 RH3 in the     treatment of pulmonary and extrapulmonary TB in the HIV positive patients.      2. To study the relationship between stage of HIV disease and response to anti-TB treatment.      3. To study recurrences and their nature (relapse/re-infection) in detail by using RFLP     analysis.      Study Design:It is a two armed prospective randomized open label controlled clinical trial     with stratified random allocation based on CD4 count and sputum smear grade.      All enrolled patients will be treated according to the RNTCP guidelines during the intensive     phase. In the continuation phase, Cat I patients will be stratified by CD4 counts and by     smear grade, and randomly allocated either to the standard RNTCP regimen, or to an     alternative extended regimen (2EHRZ3/4RH3 or 2EHRZ3/7RH3).   "
193377|NCT00376025|"     The purpose of this study is to determine whether antioxidant supplementation can have a     positive health effect on patients suffering from Kashin-Beck disease.   "
193378|NCT00376038|"     GSK189075 is intended for use as a single treatment or in combination with other treatments     for tye 2 diabetes mellitus (T2DM). Metformin is widely used in Europe and the USA for the     treatment of T2DM. This study will evaluate the effect of GSK189075 on metformin levels in     the blood in T2DM subjects. The rationale is to look for any safety problems that may result     when the 2 drugs are given together.   "
193395|NCT00376259|"     This study is being conducted to compare the safety and effectiveness of the investigational     medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently     approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus     [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination     therapy will be compared to the results for patients taking adefovir alone.   "
193426|NCT00376675|"     RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known     whether methylphenidate is more effective than a placebo in relieving fatigue and improving     quality of life in patients with cancer.      PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it works     in treating patients with fatigue caused by cancer.   "
193379|NCT00376051|"     Frontotemporal lobar degeneration(FTLD) is a common cause of early-onset dementia. FTLD is     characterized multiple behavioral symptoms including mental rigidity, irritability, emotional     blunting, disinhibition, apathy, and aggression. These behavioural disturbances are     particularly important because they increase caregiver burden and may lead to earlier     institutionalization. While the causes of FTLD are largely unknown, there is a great deal of     evidence suggesting that a brain chemical called serotonin regulates many of the behaviours     that are disturbed in FTLD. Our objective is therefore to determine whether dysfunction in     the brain's serotonin system is responsible for behavioural problems among FTLD patients. We     hope to take the first steps towards a scientific understanding of the behavioural symptoms     of FTD, and use our findings to support a larger study optimizing the treatment of targeted     behavioural disturbances in FTLD using the antidepressant citalopram.      Citalopram increases transmission by serotonin; we plan to use this medication to determine     whether there are any differences in how the serotonin system functions in FTLD patients who     display different levels of behavioural disturbances. Patients will be given citalopram and     will have their blood drawn after 2 and 3 hours to determine plasma levels of the hormones     cortisol and prolactin at those times. These hormones are good indicators of serotonergic     functioning in the central nervous system.      We expect that patients with lower levels of serotonergic functioning will have more severe     behavioural disturbances and be less responsive to treatment with citalopram. Following their     first test day, we will provide patients with a 6-week supply of citalopram, and assess them     for any changes in behaviour at the end of this treatment.      This study aims to obtain a better understanding of how changes in the serotonin system     relate to behavioural symptoms in FTLD patients. Using the information from this pilot study,     we can plan a larger study to determine whether certain behaviours will respond to treatment     with citalopram, and if so, determine whether it is possible to predict which patients, based     on individual characteristics, are most likely to respond to this treatment. This methodology     will therefore not only provide a scientific rationale for treatment of FTLD, but also     provide guidance for ongoing, individualized therapy.   "
193380|NCT00376064|"     This study will investigate the efficacy of a combination treatment with octreotide acetate     and cabergoline in acromegalic patients that are only partially responsive to a somatostatin     analog monotherapy   "
193381|NCT00376077|"     Childhood immune thrombocytopenia purpura (ITP) is a disorder characterized by the production     of antibodies against platelets, resulting in enhanced destruction of platelets. Most     children with ITP present with low platelet counts (PC) but minimal bleeding. Very rarely a     child may present with a severe life-threatening bleed, such as a bleed in the head. In this     case it is very important that the PC be raised as quickly as possible. The combination of     corticosteroids and intravenous gammaglobulin (IVIG) is commonly used in the management of     such severe bleeding in children with ITP to quickly raise the PC and yet this treatment     combination has not been tested against using IVIG alone. If it is shown that the combination     of these agents does result in a quicker rise in PC then when using IVIG alone would support     the use of this combination therapy in emergency situations.      As we can not ethically conduct this study in patients with life-threatening bleeds, we plan     to study patients with ITP and PC less than 20 X 109/L, but without life threatening     bleeding. Eligible patients will be randomized to one of these 2 regimens (IVIG + placebo or     IVIG + IV corticosteroids). The study is designed as a double-blind trial, where the patient     or the treating physician will not be aware of the regimen that a patient is randomized to.     PC's will be measured as a surrogate measure of bleeding risk; bleeding scores (a score     generated by observing patients for bleeding symptoms) will be used to grade bleeding     severity, and adverse effects to treatment will be monitored by the means of questionnaires     throughout the study.   "
193382|NCT00376090|"     The purpose of this study is to determine the safety and the immune responses to the HIV     vaccine candidate, MVA-CMDR. This vaccine was designed to induce immune responses to three     HIV passenger genes encoded with the viral vector, MVA.   "
193383|NCT00376103|"     The purpose of this study is to determine treatment related toxicity, tumor response,     progression-free survival and quality of life of newly diagnosed Glioblastoma Multiforme     (GBM) patients undergoing a combination of surgical resection, brachytherapy and external     beam radiation with concomitant temozolomide, followed by adjuvant temozolomide.   "
193384|NCT00376116|"     In spite of success in the management of heart failure, repetitive rehospitalisation and high     mortality rate remain a serious problem. Recent studies, especially the COMPANION trial, have     demonstrated that cardiac resynchronisation therapy (CRT) reduces mortality and     rehospitalisation in heart failure patients. There is also evidence that telemonitoring of     heart failure patients potentially reduces both mortality and morbidity. Recently, a Home     Monitoring (HM) function has been integrated into BIOTRONIK CRT-defibrillators and     CRT-pacemakers with a view of harnessing the powerful combination of CRT with close remote     monitoring of heart failure patients. It is possible now to transmit predefined parameters on     a daily basis from the implanted devices to a web-based platform accessible by patients'     physicians. Our study evaluates clinical usefulness of Biotronik HM function in     CRT-defibrillators and CRT-pacemakers.   "
193385|NCT00376129|"     Protocol Title: Open-label,single center study to evaluate the savety and efficacy of an     intramuscular 12 week-course of Alefacept in patients with atopic dermatitis.      Study Phase: II      Study Design: Open-label, single center Primary Study Objective: to determine the safety and     efficacy of one course of Alefasept when administered as a 15 mg intramuscular ( IM)     injektion to patients with atopic dermatitis      Secondary Study Objective: to investigate key immunological parameters involved in the     pathology of this common skin disease to interpret the clinical findings      Number of patients: 10      Study Population: Male and female patients, at least 18 years of age with atopic dermatitis,     aktive inflammation, a severity score of 6-9 according to Langeland and Rajika and an EASI of     >20      Treatment Groups: Alefacept will be administered as a 15 mg IM injection once a week for 12     weeks, followed by a 12-week follow-up period.   "
193386|NCT00376142|"     Using a theory-based approach, the purpose of this study is to identify modifiable factors     underlying professional behaviour in order to identify those processes to target with an     implementation intervention and to gain an understanding of how interventions might work and     thus be optimised.      Our principal objective is to develop interventions to change beliefs that have already been     identified as antecedents to antibiotic prescribing for sore throats and then to     experimentally evaluate these interventions to identify those which have the largest impact     on behavioural intention   "
193420|NCT00376597|"     This randomized phase III trial studies how well education with or without physical therapy     intervention works in preventing lymphedema in women with stage I, II, or III breast cancer     who are undergoing axillary lymph node dissection (surgery to remove lymph nodes found in the     armpit region). Lymphedema is a condition in which extra lymph fluid builds up in tissues and     causes swelling in an arm or leg if lymph vessels are blocked, damaged, or removed by     surgery. A personalized physical therapy intervention and education materials may be better     than education materials alone in preventing lymphedema in women with breast cancer who are     undergoing axillary lymph node dissection.   "
193421|NCT00376610|"     ASR/Re-cap versus 28 MoM   "
193387|NCT00376155|"     Antimalarial chemoprophylaxis can reduce morbidity and mortality from malaria in children.     However, this approach to malaria control has not been implemented widely because of concerns     over its possible effect on the development of resistance and natural immunity. Intermittent     preventive treatment (IPT) may be able to achieve some of the beneficial effects of     chemoprophylaxis without its drawbacks. Recently, it has been shown that IPT given to     Senegalese children under the age of five years on three occasions during the malaria     transmission season reduced the incidence of clinical malaria by approximately 90%. However,     it is uncertain how this intervention can be most effectively delivered. Therefore, 26     Maternal and Child Health (MCH) trekking clinics in Upper River Division, south of the River     Gambia, each with an average catchment population of 400-500 children under 5 years of age,     will be randomly allocated to receive IPT from the MCH trekking team or from a IPT dispenser     (village health worker, traditional birth attendant or a community mother based in a primary     health care village). Treatment with a single dose of sulfadoxine /pyrimethamine (SP) plus     three doses of amodiaquine will be given to all study subjects at monthly intervals on three     occasions during the months of September, October and November. The primary end points will     be the incidence of clinical attacks of malaria detected by passive case detection, and     cost-effectiveness of the delivery methods. Important secondary endpoints will be the     coverage and the equity of coverage of IPT in preventing malaria morbidity.   "
193388|NCT00376168|"     Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the     human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme     glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in     the cells of the monocyte-macrophage system.      This is the second trial to utilize a recombinant active form of lysosomal enzyme,     glucocerebrosidase, (human prGCD) which is expressed and purified in a bioreactor system from     transformed carrot plant root cell line.   "
193389|NCT00376181|"     The purpose of this study is to evaluate the efficacy and safety of pioglitazone-azilsartan,     once daily (QD), in subjects with type 2 diabetes mellitus with poor glycemic control.   "
193390|NCT00376194|"     This study will examine whether DMSA, an oral chelating agent that removes mercury and other     metals from the body, is beneficial for children with autism. DMSA is commonly used to treat     autism, although it has never been tested in a controlled study and there is no proof that it     helps children with the disorder. Support for its use is based on single-case reports of     benefits of chelation with DMSA. This study will help determine whether or not DMSA is useful     for treating autism.      Children between 4 and 10 years of age with autism spectrum disorder who weigh at least 33     pounds, who have detectable, but not toxic, levels of mercury or lead in the blood, and who     have not previously received chelation therapy may be eligible for this study.      Participants complete a medical history, behavioral and psychological assessment and physical     examination. Blood, hair, urine and stool samples are collected for testing.      Because DMSA can remove minerals the body needs, such as zinc and iron, as well as the toxic     lead and mercury, participants take a daily multivitamin supplement starting 1 month before     beginning chelation therapy and continuing for the duration of treatment. After 1 month of     the supplementation regimen, the children are assigned to receive DMSA or placebo for 12     weeks, divided into six 2-week cycles. They take the assigned drug 3 times a day on days 1, 2     and 3 of each cycle and continue the multivitamin every day.      The children are seen in the clinic immediately before and after the first, third and sixth     cycles. At each checkup, the parent or guardian answers a set of questions about the child's     autism symptoms, physical health and medication side effects. Blood, urine and stool samples     are collected for laboratory testing.   "
193391|NCT00376207|"     Decreased insulin sensitivity is and independent risk factor for stroke despite glycemic     control. It is known that physical exercise increases insulin sensitivity in healthy     subjects. Wether stroke patients can increase insulin sensitivity via physical exercise is     not known.      Chronic low-grade inflammation is associated with an increased risk of stroke. Physical     exercise has shown to increase IL-6 directly after exercise in untrained subjects. When     fitness is increased in each subject then the peak IL-6 concentration after exercise     decreases and so does the basal level of IL-6. It is not known whether stroke patients can     increase physical activity level to a degree where chronic inflammation are decreased.      This study is designed to evaluate if physical exercise after stroke will increases insulin     sensitivity and reduce low-grade chronic inflammation.      Stroke patients have been randomized to intervention with physical exercise or control in the     ExStroke pilot trial and followed for 2 years. Using the study population from the ExStroke     pilot trail blood samples will be obtained at the last control. Insulin sensitivity can be     measured from fasting glucose and insulin using the Homeostasis Model Assessment (HOMA).     Interleukin-6, TNF-alfa and CRP is measured to estimate chronic inflammation.   "
193392|NCT00376220|"     The Johns Hopkins Department of Psychiatry is conducting a research study to examine the     effectiveness of riluzole in treating the depressed phase of bipolar disorder. This     outpatient treatment study of medication or placebo will last 9-12 weeks. The study includes     medical and psychiatric evaluations as well as time-limited medication treatment at no cost,     and you will be compensated for your participation.   "
193393|NCT00376233|"     Increasing evidence suggests modulating effects of cannabinoids on time of onset, severity,     and outcome of schizophrenia. Efforts to discover the underlying pathomechanism have led to     the assumption of gene x environment interactions including premorbid genetical vulnerability     and worsening effects of continuing cannabis use. For a main characteristic of psychoactive     delta-9-tetrahydrocannabinol is its affinity to biological membranes, which are known to be     disturbed in schizophrenia patients and genetic high-risk populations.      Here we assess an hypothesised association between premorbid lipid disturbance and metabolic     effects of external cannabinoids in schizophrenia.      Intensity of niacin (methylnicotinate) skin flushing, indicating disturbed     prostaglandin-mediated processes, is used as peripheral marker of lipid-arachidonic acid     pathways and investigated in cannabis consuming and non-consuming schizophrenia patients and     in healthy controls. Methylnicotinate is applied in three concentrations onto the forearm     skin. Flush response is assessed in three minute intervals over 15 min using optical     reflection spectroscopy.   "
193394|NCT00376246|"     The objective of this study is to show that Ezetimibe will improve endothelial function     following high cholesterol meals in healthy subjects by decreasing absorption of cholesterol     and thus affecting concentration and composition of remnant-like particles.   "
193396|NCT00376272|"     Study purpose The purpose of the study is to show that the addition of valsartan on top of     established therapies can reduce the recurrence of atrial fibrillation in patients with a     history of recent atrial fibrillation associated with cardiovascular diseases/comorbidities.      Primary objective To demonstrate that, in patients with history of recent atrial fibrillation     treated with the best recommended therapies, the addition of valsartan 320 mg is superior to     placebo in reducing atrial fibrillation recurrence.      Study design The GISSI-AF is a prospective, multicenter, randomized, double blind, placebo     controlled study. Patients with a history of atrial fibrillation will be centrally randomized     in a 1:1 ratio to receive either valsartan or placebo.      GISSI-AF will be a pragmatic trial, with broad selection criteria to mimic real clinical     practice as much as possible. Since no special examinations or procedures are required for     the trial, the economic impact on the National Health Service will be minimized and use of     resources likely to be optimized. The enrollment period will last 12 months. The patients     will be followed up for 12 months from study entry      All prescribed treatments for AF or for the underlying cardiovascular diseases, including     ACE-inhibitors, amiodarone and betablockers, will be allowed:        -  patients should be on a stable treatment for at least one month        -  the current guideline for hypertension treatment should be applied        -  patients should not be started on ARBs during the study   "
193397|NCT00376285|"     The purpose of this study is to determine whether fenofibrate effects the toleration, safety,     or efficacy biomarkers of CP-742,033, a drug being developed for the treatment of obesity.   "
193398|NCT00376298|"     The purpose of initiating the Urology Database is to evaluate the outcomes of urology     procedures and medical management to enhance the care and treatment of urology patients.   "
193399|NCT00376311|"     To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in     patients suffering from osteoarthritis   "
193400|NCT00376324|"     Study to examine the concentration of the study drug, tigecycline, in human bone samples     following the administration of multiple doses.   "
193401|NCT00376337|"     To evaluate the efficacy and safety of micafungin in patients with proven invasive     aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy.     To compare the efficacy and safety of the micafungin therapy with the active control arm   "
193402|NCT00376350|"     This study will determine the number of visits to a chiropractor for spinal manipulation,     light massage, and ultrasound necessary for optimal relief of chronic low back pain. The     study will also determine the effectiveness of spinal manipulation.   "
193403|NCT00376363|"     The objective of this study is to compare the long-term safety and efficacy of the Ahmed and     the Baerveldt implants in patients who are undergoing aqueous shunt implant surgery for     glaucoma. One eye of eligible patients will be randomized. Outcome measures include     intraocular pressure, visual acuity, visual field, number of glaucoma medications, glaucoma     reoperations, and complications, including suprachoroidal hemorrhage, endophthalmitis,     choroidal effusion, diplopia, corneal edema, and shunt/tube erosion.   "
193404|NCT00376376|"     Single-dose studies of a fluoroquinolone are indicative of their antimicrobial activity since     little accumulation occurs with multiple doses. Single-dose studies have been utilized to     determine drug concentrations and time kill activity in serum, urine, and respiratory     tissues.      The purpose of this study is to evaluate the Urine Bactericidal Activity (UBA) of     levofloxacin (250, 500, 750, and 1000 mg) against FQ-resistant, ESBL positive E. coli     isolates. In addition, a susceptibility breakpoint concentration in the urine can also be     established for each dose of levofloxacin. Furthermore, urine concentrations and serum     pharmacokinetic parameters of levofloxacin can be determined.   "
193405|NCT00376402|"     The World Health Organisation has warned that an influenza pandemic is inevitable. The avian     influenza H5N1 virus strain is one of the leading candidates to cause the next influenza     pandemic. The elderly are likely to be a special target group for vaccination; therefore,     this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a     healthy elderly population.   "
193406|NCT00376415|"     Lessertia frutescens (L.) Goldblatt & J.C. Manning (syn. Sutherlandia frutescens (L.) R.     Br.), infusions and decoctions are widely used in South Africa as indigenous medicines, to     combat cancer, infections and symptoms associated with AIDS. The aim of this study was to     evaluate the safety of this phytotherapy in healthy adults.   "
193407|NCT00376428|"     Suppression of stop mutations in the CFTR gene with parenteral gentamicin can be predicted in     vitro and is associated with clinical benefit and significant modification of the     CFTR-mediated chloride transport in nasal and sweat gland epithelium.   "
193408|NCT00376441|"     Assess the outcomes of vaginal surgeries and its impact on sexual function and urinary     symptoms.   "
193409|NCT00376454|"     The purpose of this study was to determine the analgesic effect of GW493838 in patients with     post-herpetic neuralgia or peripheral nerve injury caused by trauma or surgery.   "
193410|NCT00376467|"     This proposal, developed in the framework of the GIMEMA, will permit:        -  to evaluate the activity and toxicity of imatinib in the treatment of Ph+ acute          lymphoblastic leukemia;        -  to evaluate the molecular response to the treatment, and to monitor the molecular status          of remission in all cases achieving or not a molecular response.      The GIMEMA has activated a network to centralize all biological samples (bone marrow and     peripheral blood) at diagnosis from all new ALL patients. This will permit to identify, in     particular, Ph + and/or BCR/ABL + cases within 5 days from diagnosis, thus permitting to     treat these patients according to different programs on the basis of the presence of Ph     chromosome.   "
193422|NCT00376623|"     The trial will be performed to evaluate whether BI 2536 may be effective in the treatment of     advanced or metastatic NSCLC of stage IIIB or IV in patients who relapsed after or failed     first-line therapy. A secondary aim is to identify the most suitable dosage schedule for the     further Phase II and III clinical programme of BI 2536. To achieve this objective two dosage     schedules are compared.   "
193423|NCT00376636|"     This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood     pressure in patients with mild to moderate hypertension.   "
193424|NCT00376649|"     Subjects that participate in the practical workshop will improve their quality of life and     will stay longer in remmision , in compare to the participants that will continue their     regular threatment   "
193411|NCT00376480|"     RATIONALE: Giving total-body irradiation and chemotherapy, such as thiotepa and fludarabine,     before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It     also helps stop the patient's immune system from rejecting the donor's stem cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving methylprednisolone and antithymocyte globulin before transplant and peripheral blood     cells that have been treated in the laboratory after transplant may stop this from happening.      PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated     peripheral blood cell infusion after donor stem cell transplant in treating patients with     hematologic cancers or other diseases.   "
193412|NCT00376493|"     Patients with infected abortion will be treated with dilatation and curettage, intravenous     antibiotics. The purpose of this study is to verify if it is necessary to keep the use of     oral antibiotics after hospital discharge.   "
193413|NCT00376506|"     This study will compare an implant with the technique of sensory training to determine which     method may improve the ability to swallow and reduce the risk of choking. Many people with a     brain injury or neurological disorders experience difficulty in swallowing. Past studies have     shown that an electrical pulse applied to muscles or an increase in sensory stimulation to     the throat can help.      Patients ages 18 to 90 who have had a brain injury or neurological disorder and who have had     trouble swallowing for 6 months or longer may be eligible for this study. Patients will     undergo a physical examination, pregnancy test, and exam by a throat and speech physician.     Fiber-optic endoscopic evaluation of swallowing with sensory testing involves a flexible tube     passed through the nose to the back of the throat to allow observation of the voice box.     Videofluoroscopy, an X-ray of the head and neck, will be done while patients swallow.     Patients experiencing trouble with the upper esophagus may undergo additional procedures,     including manometry to measure pressure changes in the back of the throat, and reevaluation     through the fiber-optic tube. Patients in this study will have a magnetic resonance imaging     (MRI) scan, which uses a strong magnetic field to obtain images of the body. Patients will     lie on a table that slides into the enclosed tunnel of the scanner. The scan will take 20 to     25 minutes.      Patients will be assigned randomly to one of two groups: the intramuscular group, to have a     stimulation device implanted in the neck, and the vibrotactile group, to receive a     vibrotactile stimulator. All patients will have 10 training sessions with their devices, plus     follow-up. Those patients in the first group will undergo surgery, under general anesthesia,     for the implant. Three weeks following the implant procedure, patients will come to NIH to     have the stimulator turned on and programmed and to learn how to use the device. Those     patients in the second group will have about 2 to 3 weeks of training in using a vibrotactile     device, and then they will take it home to use. All patients will return to NIH at 3 months     to ensure proper use of the devices, and they will visit for follow-up at 6 months and 12     months for tests and questionnaires.   "
193414|NCT00376519|"     RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body     irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of     cancer or abnormal cells and prepares the patient's bone marrow for the stem cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem     cells may replace the patient's immune cells and help destroy any remaining cancer or     abnormal cells (graft-versus-tumor effect). Giving an infusion of the donor's T-regulatory     cells before the transplant may help increase this effect. Sometimes the transplanted cells     from a donor can make an immune response against the body's normal cells. Giving cyclosporine     and mycophenolate mofetil after the transplant may stop this from happening.      PURPOSE: This phase I trial is studying the side effects and best dose of umbilical cord     blood T-regulatory cell infusion followed by donor umbilical cord blood transplant in     treating patients with high-risk leukemia or other hematologic diseases.   "
193415|NCT00376532|"     Assess whether serum levels of MMP 2 and or MMP 9 correlate with episodes of ventricular     tachycardia or fibrillation in patients who have implantable cardioverter defibrillator     devices.   "
193416|NCT00376545|"     This study will explore how the areas in the brain are connected to link what people see to     what they do; that is, how they use what they see to help guide their movements. The study     uses functional magnetic resonance imaging (fMRI) to look at different areas in the brain     while a person performs tasks in which both what they see (visual input) and what they do     (their motor response) are related or unrelated.      Healthy, right-handed normal volunteers who are 18 years of age or older may be eligible for     this study. Candidates are screened with a medical history, neurological examination and MRI     scan, if one has not been done within a year of entering the study. MRI uses a magnetic field     and radio waves to produce images of body tissues and organs. The subject lies on a table     that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud     knocking sounds that occur during scanning. The procedure lasts about 90 minutes, during     which the subject is asked to lie still for up to 30 minutes at a time.      Participants undergo fMRI for this 1-day study. fMRI differs from ordinary MRI in that the     subject performs tasks during the scanning, allowing researchers to see brain changes that     occur during performance of the activity. Before the scan, the subject is trained for the     tasks, which include looking at shapes while following them with the fingers and looking at     shapes without making finger movements. Following the testing, subjects have a second     ordinary MRI scan.   "
193417|NCT00376558|"     The purpose of this study is to determine whether patients with the greatest loss of dopamine     transmission due to cocaine dependence at pre-treatment PET and MRI scans will be those who     fail to respond to substance abuse treatment. This study will also determine whether patients     who do respond to treatment will experience a recovery of dopamine function. This study     includes free brain imaging and behavioral intervention. Compensation provided for the brain     scans.   "
193418|NCT00376571|"     How to use drug eluting stents (DES) in bifurcation lesions. A strategy of routine stenting     of both main vessel and side branch versus a strategy of routine main vessel stenting and     optional treatment of side branch. A randomized Nordic multicenter study including 400     patients with angina pectoris with clinical angiographic follow-up.   "
193419|NCT00376584|"     This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is     appropriate to evaluate the efficacy of MK0524 to improve the tolerability of     extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.   "
193425|NCT00376662|"     To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT     plus etidronate and no treatment over 5 years in the prevention and treatment of     glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.   "
193427|NCT00376688|"     This phase II trial studies how well temsirolimus works in treating patients with locally     advanced or metastatic breast cancer. Temsirolimus may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
193429|NCT00376714|"     GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being     developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long     duration of action of GSK233705 when administered via inhalation in animal models supports     the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary     disease.   "
193430|NCT00376727|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them.      PURPOSE: This phase I trial is studying the side effects and best dose of cetuximab in     treating patients with advanced solid tumors.   "
193431|NCT00376740|"     The purpose of this study is to determine whether zoledronic acid given intravenously every 6     months can prevent reduction in bone mineral density in women with early stage breast cancer     receiving adjuvant therapy with the aromatase inhibitor drug letrozole, after having received     adjuvant tamoxifen.   "
193432|NCT00376753|"     This study will examine and compare brain activity in people with focal hand dystonia (FHD)     and healthy volunteers to obtain further knowledge about the underlying cause of FHD.     Patients with dystonia have muscle spasms that cause abnormal postures while trying to     perform a movement; FHD affects the hands and fine finger movements. During fine finger     movement, the brain controls muscles in a process called surround inhibition. This process     may be impaired in people with hand dystonia, leading to uncontrolled overactivity in muscles     and impairing motor function.      Healthy volunteers and patients with FHD over 18 years of age may be eligible for this study.     Candidates are screened with a physical and neurological examination.      In a series of three experiments conducted during a single clinic visit, participants undergo     transcranial magnetic stimulation (TMS) while performing a finger movement. A wire coil is     placed on the subject's scalp. A brief electrical current is passed through the coil,     creating a magnetic pulse that travels through the scalp and skull and causes small     electrical currents in the outer part of the brain. The stimulation may cause muscle, hand or     arm twitching, or may affect movement or reflexes. During the stimulation, the subject is     asked to contract one finger.      In addition to TMS, subjects have surface electromyography. For this test, they sit in a     chair with their hands placed on a pillow on their lap. The electrical activity of three     muscles in the right hand is recorded by electrodes (small metal disks) taped to the skin     over the muscles.   "
193433|NCT00376766|"     This is a double blind, placebo controlled, add-on clinical trial, of levetiracetam efficacy     and safety, in epilepsy cluster seizure.      Efficacy is evaluated in the range of 2 to 24 hours after taking the tablet. If the patient     has a seizure during this interval, he is considered as a non-respondent patient.   "
193434|NCT00376779|"     The purpose of this study is to show that the immunogenicity of newly formulated     DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed     formulation of the vaccine. The vaccine will be administered as a primary vaccination course     to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be     assessed.   "
193435|NCT00376792|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     docetaxel after surgery may kill any tumor cells that remain after surgery. Sometimes, after     surgery, the tumor may not need more treatment until it progresses. In this case, observation     may be sufficient. It is not yet known whether giving docetaxel after surgery is more     effective than observation in treating prostate cancer.      PURPOSE: This randomized phase III trial is studying docetaxel to see how well it works     compared with observation in treating patients who have undergone radical prostatectomy for     prostate cancer.   "
193436|NCT00376805|"     RATIONALE: Giving chemotherapy before a donor natural killer (NK) cell infusion helps stop     the growth of tumor cells. It also helps stop the patient's immune system from rejecting the     donor's cells. Giving NK cells from a related donor may kill the tumor cells.      PURPOSE: This study furthers the research of previous studies (MT2003-01 and MT2004-25) which     were to determine a specific preparatory regimen (cyclophosphamide and fludarabine) could     create an environment in which infused NK cells can grow and effectively treat patients with     relapsed AML. This study will test the previous regimen in patients with breast cancer.   "
193437|NCT00376818|"     RATIONALE: Yoga, meditation, and breathing exercises may help lower stress and improve     quality of life in patients with malignant brain tumors and their family caregivers.      PURPOSE: This clinical trial is studying how well a stress reduction program works to improve     the quality of life of patients with malignant brain tumors and their family caregivers.   "
193438|NCT00376831|"     Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy     procedure.      There are various protocols and methods used to prevent discomfort and alleviate pain.     Conscious sedation is one of the options recommended by the American Society for     Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the     physician's discretion.      This study will attempt to recommend a preferred protocol based on a double blind randomized     prospective method.      The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and     fentanyl for sedation in ambulatory colonoscopies.      The results will be compiled from objective data and patient and physician interviews.   "
193439|NCT00376844|"     RATIONALE: External-beam radiation therapy uses high-energy x-rays to kill tumor cells.     Implant radiation therapy uses radioactive material placed directly into or near a tumor to     kill tumor cells. Giving external-beam radiation therapy or implant radiation therapy after     surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the     tumor may not need more treatment until it progresses. In this case, observation may be     sufficient. It is not yet known whether radiation therapy is more effective than observation     when given after surgery in treating stage I endometrial cancer.      PURPOSE: This randomized phase III trial is studying external-beam radiation therapy or     implant radiation therapy to see how well they work compared with observation in treating     patients who have undergone surgery for stage I endometrial cancer.   "
193515|NCT00377845|"     The purpose of this study is to compare suitability, specificity and sensitivity of the     routine smear and the tampon self-test women perform at home.      Study hypothesis: The tampon self-test correspond to the routine cervical smear.   "
193440|NCT00376857|"     It was the aim of the present study to prospectively compare the functional and morphological     outcome of idiopathic epiretinal membrane surgery with and without the assistance of     Indocyanine green (ICG). The main outcome measure was improvement of best-corrected visual     acuity (BCVA). This was treated as an open question and we had no hypothesis which of the two     therapies was superior.   "
193441|NCT00376870|"     Restenosis requiring reintervention is still a limitation of percutaneous coronary     angioplasty. Despite the use of Drug eluting stent (DES), the rate of restenosis remains 7%     to 16% in diabetic patients, making it a challenging problem in interventional cardiology.      Still, in clinical trials, most of these attempts did not successfully limit neointimal     formation after coronary stenting.      Thiazolidinediones (TZDs), like pioglitazone (pio) or rosiglitazone, are a novel class of     oral antidiabetic agents currently used to treat patients with type 2 diabetes mellitus.      These agents increase insulin sensitivity and, as such, have favorable effects on blood     glucose levels and the lipid profile in treated patients.      Beyond their metabolic action, TZDs have been shown to exhibit antiinflammatory and     antiatherogenic effects in vascular cells in vitro and to limit lesion development in various     animal models of arteriosclerosis.      Moreover, TZDs inhibit VSMC proliferation and migration, 2 critical processes in neointimal     formation after coronary stenting.      Data from rodent models suggest that TZDs limit intimal proliferation after vascular injury,     and in clinical studies with type 2 diabetic coronary artery disease (CAD) patients, TZDs     have been shown to reduce neointimal formation as well as restenosis after coronary stent     implantation.      Still, it remains unclear to what extend these effects depend on the metabolic action of     these drugs and what might mainly be due to the improvement in glycemic control.      Recently a few reports on prevention of restenosis in type 2 diabetic patients (T2DM) with     the use of TZDs as been published. All of them uses BMS as endoprosthetic devices. None of     these evaluated the use of TZDs in combination with DES.      Aim of the study is to evaluate the efficacy of pioglitazone in prevention of in-stent     restenosis after successful implantation of a sirolimus-eluting coronary stent for treatment     of de-novo complex coronary vessel disease in patients with T2DM and stable coronary artery     disease.      Study primary end-point are late-loss at 9 months.Secondary end-point include binary     restenosis MACE at 1, 9 and 12 month, stent thrombosis at 12 months.   "
193442|NCT00376883|"     Multiple myeloma is a malignant hematological disease dominated by monoclonal plasma cells in     the bone marrow. Major symptoms are related to the bones due to an increased bone resorption     and a decreased bone formation leading to bone pain and increased risk of fractures. The     normal osteoclasts are responsible for bone degradation through stimulation from the     malignant plasma cells. Bisphosphonates have been shown to inhibit the osteoclast activity     but may have serious side-effects due to renal toxicity and the optimal dose have not been     established.      In a randomized double blinded design it is aim to compare the standard of monthly injections     of 90 mg pamidronate with 30 mg.      The primary end-point is physical function estimated by EORTC QLQ-C30 questionnaire at 12     months after starting the treatment in newly diagnosed treatment demanding multiple myeloma.     Secondary end-points are skeletal related events, cost-utility analysis, response, response     duration and survival and quality of life with respect to fatigue and pain.   "
193443|NCT00376896|"     This is a three-period crossover study to compare GW876008 and placebo to see if GW876008     will normalise blood flow responses after different emotional stimuli.   "
193444|NCT00376909|"     RATIONALE: Studying the barriers that prevent minority and low-income women from undergoing     cancer screening, and offering encouragement to them over the telephone, may help improve     cancer screening rates.      PURPOSE: This randomized phase II trial is studying how well a telephone-based Prevention     Care Manager increases screening rates for breast cancer, cervical cancer, and colorectal     cancer in minority and low-income women.   "
193445|NCT00376922|"     RATIONALE: Listening to relaxing music during a bone marrow biopsy may be effective in     reducing anxiety and pain.      PURPOSE: This randomized clinical trial is studying how well music works in reducing anxiety     and pain in adult patients undergoing bone marrow biopsy for hematologic cancers or other     diseases.   "
193446|NCT00376935|"     Palifermin is a modified version of a naturally occurring human growth factor that is     currently approved by the FDA to treat blood cancers. The purpose of this study is to     determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected     adults.   "
193447|NCT00376948|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Genistein may help gemcitabine and erlotinib kill more tumor cells by making tumor     cells more sensitive to the drugs.      PURPOSE: This phase II trial is studying how well giving genistein together with gemcitabine     and erlotinib works in treating patients with locally advanced or metastatic pancreatic     cancer.   "
193448|NCT00376961|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and     bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the     cancer from progressing.      PURPOSE: This phase II trial is studying how well giving rituximab together with combination     chemotherapy and bortezomib followed by bortezomib alone works in treating patients with     newly diagnosed mantle cell lymphoma.   "
193449|NCT00376974|"     With patient education, the compliance with glaucoma medications will increase.   "
193450|NCT00376987|"     RATIONALE: Zinc supplements may lower cadmium levels in smokers and may help prevent DNA     damage.      PURPOSE: This clinical trial is studying how well zinc supplements work in lowering cadmium     levels in smokers.   "
193451|NCT00377000|"     Evaluate patient preference factors comparing two clindamycin/benzoyl peroxide gels. One     dispensed in a pump presentation, the other in a tube presentation.   "
193452|NCT00377026|"     This a pilot intervention study in which postpartum women will be randomized to receive a     6-month postpartum weight loss intervention or usual care.   "
193453|NCT00377039|"     This is a multicentre, randomized, double-blind, placebo controlled, parallel group     exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the     treatment of fibromyalgia in female subjects.   "
193516|NCT00377858|"     A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral     antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral     antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.   "
193454|NCT00377052|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy,     such as gemcitabine, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Bortezomib may help gemcitabine work     better by making cancer cells more sensitive to the drug.      PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine     works in treating patients with relapsed mantle cell lymphoma.   "
193455|NCT00377065|"     This is a treatment use study to provide early access to MK0518 for the treatment of HIV-1     infection in patients who have limited or no treatment options due to virological failure,     resistance, or intolerance to multiple antiretroviral regimens. Enrollment in this study is     patient driven. Investigators are not proactively assigned. There is no target sample size     and duration of the study is indefinite. For information on how to enroll in the study, see     link below.   "
193456|NCT00377078|"     Primary objective of this pilot study is to evaluate the effect of recombinant human     lactoferrin on the rate of infection with Clostridium difficile in long-term care patients     supported by enteral feeding requiring broad spectrum antibiotics.   "
193457|NCT00377091|"     This study compares two blood thinners which are both accepted standard cares, fondaparinux     and unfractionated heparin (UFH). These drugs are used to prevent the growth of existing     blood clots and formation of additional blood clots in patients with pulmonary embolism (a     blood clot in the lung) as they are beginning to take warfarin (another standard care blood     thinner). Patients will be invited to participate because they have been diagnosed with a     pulmonary embolism, require anticoagulation therapy (treatment with a blood thinner), and are     currently hospitalized.      The purpose of this study is to determine if patients treated with fondaparinux will have     shorter hospital stays and lower costs of treatment while in the hospital than similar     patients receiving a different standard care with UFH. Fondaparinux is already approved by     the FDA for use in patients with pulmonary embolism, for both inpatient and outpatient care,     as long as treatment is begun with warfarin while they are hospitalized. It is therefore not     an experimental treatment. The study is being conducted to determine which FDA approved     treatment is the best practice for hospital treatment of pulmonary embolism. The study will     also examine the safety and effectiveness of fondaparinux in local use.   "
193458|NCT00377104|"     This phase I trial is studying the side effects and best dose of flavopiridol in treating     patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used     in chemotherapy, such as alvocidib, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing.   "
193459|NCT00377117|"     The purpose of this study is to learn more about the relationship between serious mental     illness and the detection and management of diabetes and pre-diabetic conditions. Patients     who have been diagnosed with schizophrenia are at an increased risk for developing diabetes     and pre-diabetic conditions such as impaired glucose tolerance and impaired fasting glucose.     In addition, novel antipsychotics have also been linked to impaired glucose metabolism and     increased incidence of diabetes. The medical management of these patients may be difficult ot     achieve through standard family practice. The objectives of this project are to: screen a     sample of this high-risk population using an Oral Glucose Tolerance Test (OGTT), and to     provide multidisciplinary team support to those identified as having diabetes or a     pre-diabetic condition.   "
193460|NCT00377130|"     RATIONALE: A stress-management program may improve quality of life and reduce anxiety and     depression in patients receiving chemotherapy for cancer.      PURPOSE: This randomized clinical trial is studying how well stress management therapy works     in patients receiving chemotherapy for cancer.   "
193461|NCT00377143|"     Warfarin (also called Coumadin®) is an anticoagulant drug (blood thinner) given to patients     to help prevent blood clots from forming or to help prevent the growth of an existing blood     clot. The purpose of this study is to collect information on a possible method used to     determine the best warfarin dose for people before they start warfarin. This study will focus     on finding out if a person's stable dose can be better predicted by using a new approach     (called pharmacogenetic-guided dosing) compared to the current warfarin dosing method. The     pharmacogenetic-guided dosing method (the new warfarin dosing method) will use a person's     specific health and genetic information to calculate a patient's warfarin dose at the     beginning of warfarin treatment. The hope is that through this research, we may someday be     able to use an individual's genetic information to guide the selection of their specific     warfarin dose at the beginning of treatment, leading to precise warfarin dosing and less need     for the current trial and error process.   "
193462|NCT00377156|"     RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause     less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells.     It is not yet known whether stereotactic radiation therapy is more effective with or without     whole-brain radiation therapy in treating patients with brain metastases.      PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and     whole-brain radiation therapy to see how well they work compared with stereotactic radiation     therapy alone in treating patients with brain metastases.   "
193463|NCT00377169|"     The purpose of this study is to collect blood samples from SMART study participants to use in     future genetic studies.   "
193464|NCT00377182|"     This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor     pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS     + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to     receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV     polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All     patients who receive at least one dose of study medication will receive open label PEGASYS +     Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time     on study treatment is 3-12 months, and the target sample size is <100 individuals.   "
193517|NCT00377871|"     Hypothesis: Stentless bioprostheses will perform superior to stented bioprostheses in     different hemodynamic and biomechanical parameters.      The study will investigate turbulence, flow and aortic root movement in a stentless     bioprosthesis and compare it to a stented bioprosthesis.   "
193518|NCT00377884|"     Investigation of serologic bone markers in patients undergoing hip arthroplasty   "
193465|NCT00377195|"     This prospective study will test the following hypotheses in patients with stage I-II low     grade marginal zone (MZ) lymphoma:        -  Involved Field Radiotherapy will produce a complete response rate of > 90%        -  Radiotherapy will be associated with a locoregional progression of < 20% after 10 years        -  Death from MZ lymphoma will occur in < 40% of patients within 10 years of radiotherapy      This study secondary objectives are:        -  To collect information on the prevalence of H. pylori in non-gastric MALT lymphoma        -  To estimate rates of acute and late toxicity of radiotherapy   "
193466|NCT00377208|"     High blood pressure affects 65 million adults in the United States, and more than one third     of these individuals do not have adequate control of their blood pressure. Individuals who     ask specific questions and discuss important medical issues with their doctors are more     likely to receive appropriate medical care than individuals who do not. This study will     evaluate the effectiveness of an interactive web site that provides individualized feedback     and encourages doctor-patient communication as a way to maintain adequate blood pressure     control.   "
193467|NCT00377221|"     Observational, cross-sectional, single-visit study of 896 men and women in Los Angeles, CA     and Baltimore, MD including a computer-assisted interview focusing on the behavioral     repertoire surrounding RAI, symptoms, and health seeking behaviors and a multidimensional     assessment of behaviors, anorectal examination, and testing for sexually transmitted     infections (STIs).   "
193468|NCT00377234|"     This 2 arm crossover study will evaluate patient reported preference for either once monthly     Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal     osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12     weeks; they will then cross over to receive the alternative treatment for a further 12     weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample     size is 100-500 individuals.   "
193469|NCT00377247|"     The primary goal of this study is to determine if the vaccine can be safely given to     subjects, and to see what side effects occur (both good and bad) when they are given this     experimental tumor vaccine. During this study, investigators intend to watch for tumor     response while examining the effects of this vaccine on the body's immune system after it is     given.   "
193470|NCT00377260|"     The purpose of this study is to learn whether or not all children with ear infections (acute     otitis media or AOM) should be treated with antibiotics. The study will compare two treatment     strategies, watchful waiting or treatment with antibiotics, to determine which is more     appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23     months, with AOM will be enrolled in the study. They will be treated either with Augmentin     (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will     be asked to write information about their child in a Patient Diary. A general physical exam,     including an ear exam, will be performed 4 times during the study. A mucus sample will be     collected from the back of each child's nose. Parents will be asked questions during phone     calls and at every visit. If a child has not improved or has worsened, the investigators will     prescribe a different antibiotic that is known to kill resistant germs.   "
193471|NCT00377273|"     This study is being undertaken to: 1. assess the safety of fluorouracil cream for the     treatment of actinic keratoses (AKs) on other common skin surface areas (e.g., posterior     scalp, ears, neck, lips, arms and hands); 2. collect additional post-treatment safety data on     fluorouracil cream applied to the face (including anterior scalp, if applicable); 3. assess     the incidence of recurrence of AKs on the face; and 4. assess the need for re-treatment with     fluorouracil cream to the face.   "
193472|NCT00377286|"     The goal of this study is 1) to develop a biomarker of of cartilage synthesis by determining     if there is a relationship between changes in the status of knee cartilage and the amount of     a biomarker called CTX-II in urine. 2) We will also characterize people who have experienced     cartilage loss and/or reduced functional ability using performance tests and a questionnaire.     3) The administration of glucosamine in a beverage for six months will be used to promote the     alteration in cartilage status and improve function in people with mild to moderate joint     pain. A secondary goal will be to assess the effect of glucosamine on the skin in a small     subset of women.   "
193473|NCT00377299|"     Bipolar disorder (BD) is a common and severe psychiatric illness. Drug and alcohol abuse are     very common in people with BD and other mood disorders and are associated with increased     rates of hospitalization, violence towards self and others, medication non-adherence and     cognitive impairment. However, few studies have investigated the treatment of dual-diagnosis     patients as substance use is frequently an exclusion criterion in clinical trials of patients     with BD. To address this need, we have developed a research program that explores the     pharmacotherapy of people with BD and substance related-disorders. A potentially very     interesting treatment for BD is citicoline. Some data suggest that this supplement may     stabilize mood, decrease drug use and craving, and improve memory. We found promising results     with citicoline in patients with BD and cocaine dependence. In recent years the use of     amphetamine and methamphetamine has become an important public health concern. However,     virtually no research has been conducted on the treatment of amphetamine abuse. We propose a     double-blind placebo controlled prospective trial of citicoline in a group of 60 depressed     outpatients with bipolar disorder, depressed phase or major depressive disorder and     amphetamine abuse/dependence, to explore the safety and tolerability of citicoline, and its     efficacy for mood symptoms, stimulant use and craving and its impact on cognition. Our goal     is to determine which symptoms (e.g. mood, cognition, substance use) citicoline appears to be     most effective and estimate effect sizes for future work.   "
193474|NCT00377312|"     Study consists of an eight day inpatient visit on the General Clinical Research Center. The     investigators' specific aims are to:        1. To define the maximum safe dose of a seven day continuous administration of parathyroid          hormone [PTH(1-34)] in healthy human volunteers.        2. To estimate the effect of a seven day continuous administration of parathyroid Hormone          (PTH) in escalating doses on vitamin D metabolism, markers of bone turnover and          fractional excretion of urine.   "
193475|NCT00377325|"     This study will evaluate whether lower doses of cyclosporine can cause fewer side effects and     still produce the same beneficial results that are seen with a standard cyclosporine dose     regimen when treating individuals with moderate to severe psoriasis.   "
193476|NCT00377338|"     Fibered confocal fluorescence microscopy (FCFM), also referred to as Cell-Vizio® (MaunaKea     Technologies, France) is a new technique that produces microscopic imaging in a living     tissue, through a 1 mm fiberoptic miniprobe that can be introduced into the working channel     of the bronchoscope. The system produces real-time imaging of endogenous fluorophores with a     5 µm lateral resolution and a field of view of 600 x 600 µm. FCFM is able to produce dynamic,     high-resolution microimaging of the respiratory bronchiolar walls, alveolar ducts and sacs in     vivo during endoscopy (a procedure termed as alveoscopy).      The hypothesis of this study is that an alveoscopy makes it possible to analyze the     microstructure of the distal airways in vivo and to collect specific morphologic information     in patients with interstitial lung diseases.      The goals of this French Phase II trial are:        -  to evaluate the tolerance of the alveoscopy        -  to describe the normal appearance of the bronchoalveolar system in spontaneous          ventilation in normal subjects        -  to describe specific alterations of the bronchoalveolar microstructure in focal or          diffuse interstitial lung diseases   "
193477|NCT00377351|"     Amyotrophic Lateral Sclerosis (ALS) is a rare but rapidly progressive neurological disease     that often results in death within a few years after the diagnosis. The incidence of ALS in     the US is approximately 2.0/100,000/year and is age dependent. Very few epidemiological     studies have investigated the causes of ALS. Last year, Dr. Alberto Ascherio at Harvard     School of Public Health successfully obtained a RO1 grant to investigate the risk of ALS by     documenting ALS cases in five well-established large prospective cohorts: The Nurses' Health     Study (NHS), the Health Professionals Follow-up Study (HPFS), the Cancer Prevention Study II     Nutrition Cohort (CPS IIN), the Multiethnic Cohort (MEC), and the NIH-American Association of     Retired Persons Diet and Health Study (AARP-DH). The primary aims of this grant are to     prospectively clarify the associations between diet and smoking and risk of ALS in this to     date the largest epidemiological study on ALS. Incident ALS cases will be documented via     biennial questionnaires in the first three cohorts. While mortality data will be obtained in     the MEC and AARP-DH cohorts by searching the National Death Index (NDI) Plus, it is also     desirable to identify surviving incident cases in these two cohorts.      The objective of this specific proposal is to ascertain the self-reported incident ALS cases     from the AARP-DH study and obtain consent for medical release following the procedures set up     for Parkinson's disease (PD) cases in the currently approved Parkinson's Genes and     Environment (PAGE) Study IRB approval #06-E-N093. The confirmed ALS cases may be analyzed as     part of the RO1 project. We expect to identify 300 self-reported ALS cases from the AARP     cohort. Detailed analytic plans will be coordinated with Dr. Ascherio.   "
193478|NCT00377364|"     Studies in humans and animals support that stress and/or elevations in corticosteroids lead     to changes in hippocampal structure and functioning. This is important as patients with major     depression frequently have elevated cortisol, and millions of patients receive prescription     corticosteroids (e.g. prednisone). Both depression and corticosteroid therapy are associated     with memory impairment and hippocampal atrophy. Our research uses corticosteroid-treated     patients to explore interventions that might protect the brain from the effects of stress or     corticosteroids. We propose to give 30 corticosteroid-treated asthma patients acetaminophen     or placebo. Between group differences in mood, memory and other neurocognitive measures will     serve as outcome measures.   "
193479|NCT00377377|"     EP01572 is a peptidomimetic growth hormone secretagogue, which has potent GH-releasing     activity after intravenous administration.It is an analogue of the natural compound ghrelin.     Since an oral delivery system would be preferable in many of the possible therapeutic     indications, the pharmacological profile and the GH-releasing activity of increasing single,     oral doses of EP01572 in healthy volunteers will be evaluated. In addition, the     pharmacokinetics and pharmacological effects of EP01572 will be investigated after     intraduodenal administration.   "
193480|NCT00377390|"     The purposes of this study are to determine the effects of omalizumab on cells involved in     the allergic response, to evaluate predictors of response to omalizumab, and to determine     whether response to omalizumab therapy is influenced by the environment. A subset of     inner-city children and adolescents currently enrolled in Inner-City Anti-IgE Therapy for     Asthma (a clinical trial of omalizumab) will be enrolled in this study.   "
193481|NCT00377403|"     This study will compare the symptom relief provided by 5 cold medicines versus the symptom     relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who     have sinus infections. Treatment with amoxicillin may be more effective than treatment with     cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus     infections will participate in this study for 28 days. Volunteers will receive a 10-day     course of either amoxicillin or placebo (substance containing no medication). In addition,     all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and     cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10,     and 28 following the start of treatment. The study will look at quality of life factors such     as change in functional status (ability to perform daily activities) and symptoms, recurrence     of the infection, satisfaction with care, and the direct costs of treatment.   "
193482|NCT00377416|"     Individuals with a deficiency of the Alpha 1-antitrypsin (AAT) protein are at risk for     developing emphysema and liver damage. Researchers have developed a way to introduce normal     AAT genes into muscle cells so that the AAT protein is produced at normal levels. This study     will evaluate the safety of the experimental gene transfer procedure in individuals with AAT     deficiency.   "
193483|NCT00377429|"     The purpose of this study is to determine whether the investigational drug catumaxomab     delivered in the planned treatment schedule is a safe and effective treatment for women with     advanced ovarian cancer who experience a complete response to chemotherapy.   "
193484|NCT00377442|"     This study will assess the potential pharmacokinetic interaction between GK Activator (2) and     simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK     Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6     treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin     80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study     days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. The     anticipated time on study treatment is <3 months, and the target sample size is <100     individuals.   "
193485|NCT00377455|"     The purpose of this study is to determine whether the drug Bosentan improves exercise     tolerance in scleroderma patients.   "
193487|NCT00377481|"     This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin     alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive     comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon     (6000IU). They will then be crossed over to the alternative treatment arm for further     treatment. After each injection pain will be assessed using the visual analogue scale (VAS)     and 6-point verbal rating scale (VRS), and patient preference will be assessed. The     anticipated time on study treatment is <3 months, and the target sample size is <100     individuals.   "
193488|NCT00377494|"     The purpose of this study is to evaluate the safety, tolerability, and effectiveness of 2     doses of a malaria vaccine (DNA) followed by a dose of another type of malaria vaccine (MVA)     given as a booster. Forty-eight adults in Ghana, ages 18-50 years, will participate for 17     months. They will be randomly assigned to 1 of 4 treatment groups. Group 1 will receive the     DNA malaria vaccine at months 0 and 1, and the booster at month 7. Group 2 will receive a     rabies vaccine at months 0 and 1, and an injection containing no vaccine at month 7. Group 3     will receive the DNA malaria vaccine at months 5 and 6, and the booster at month 7. Group 4     will receive the rabies vaccine at months 5 and 6, and an injection containing no vaccine at     month 7. Blood samples and information regarding health problems that may occur after     vaccination will be collected.   "
193489|NCT00377507|"     The Purpose of this study is to evaluate the effects of catechin mouth-washing on the removal     of intraoral bacteria in the elderly   "
193490|NCT00377520|"     The intent of this protocol is to screen a new agent for activity in patients with advanced     or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed     disodium works in treating patients with advanced or recurrent endometrial carcinoma.   "
193491|NCT00377533|"     Currently available wheelchairs are often fitted with conventional rear anti-tip devices     (C-RADs) to prevent wheelchair rear tips. The limitations of C-RADs have provided an     incentive for the design of rear anti-tip devices that permit more rear tip without     compromising safety (Arc-RADs).      The purpose of this study is to test the hypothesis that caregivers handling occupied     wheelchairs equipped with Arc-RADs have higher success rates on RAD-relevant skills than     caregivers handling wheelchairs equipped with C-RADs.   "
193492|NCT00377546|"     To compare the penetration of three different NSAIDs.   "
193493|NCT00377559|"     This is an open phase II multicentre study evaluating the efficacy and safety of the non     pegylated liposomal doxorubicin (Myocet®) and docetaxel (Taxotere®) combination as first-line     treatment of patients with metastatic HER2/neu negative breast cancer.   "
193494|NCT00377572|"     The purpose of this study is to find out if adding omalizumab to standard asthma treatment     results in a safer, more effective, and longer lasting asthma treatment strategy than     standard treatment alone, in inner-city children with mild to severe asthma.   "
193495|NCT00377585|"     The study is designed to demonstrate a meaningful difference in immunogenicity between the     candidate adjuvanted vaccine compared to the licensed Fluarix vaccine in subjects aged 50     years and above.      A control group in younger adults aged 18 to 40 years was included.   "
193496|NCT00377598|"     The purpose of this study is to evaluate the efficacy of TAK-583, once daily (QD), in     relieving pain in subjects with postherpetic neuralgia.   "
193497|NCT00377611|"     An observational study to investigate the incidence of influenza and influenza-related     complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated     with Fluarix™   "
193498|NCT00377624|"     Three-arm, parallel, double-blind, masked observer, randomized, PB-Saline controlled clinical     trial. In order to avoid problems in the interpretation of the final results due to disparate     enrollment from various centers, the number of patients enrolled per site will be the same     per site. Study patients will be randomized to receive either 20 mg sodium hyaluronate, 3     i.a. sodium hyaluronate injections, followed by 2 PBSaline mock i.a. injections or 5 i.a.     PB-Saline control injections. One investigator will administer the injection and the joint     assessor will be blinded to the study. The anterior or posterior approach for the shoulder     injection will be used.   "
193499|NCT00377637|"     This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to     cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term     efficacy of MMF compared to azathioprine in maintaining remission and renal function.     Patients were randomized to receive either MMF (1.5 g twice daily [bid]) or cyclophosphamide     (0.5-1.0 g/m^2 in monthly pulses) in the induction phase. Those patients meeting criteria for     response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g     bid) or azathioprine (2 mg/kg/day).   "
193500|NCT00377650|"     Aim Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy     system leading to thrombus reduction.      Study design:      Multicenter, prospective, opened, randomized.      Primary endpoints:      ST resolution >70% 60 minutes after PCI      Secondary endpoints:      Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI     thrombus scale ≥ 1 TIMI 3 flow after PCI MBG 3 CMR – infarct size, measurement of left     ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF) ECHO:     measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection     fraction (EF) and wall motion score index (WMSI) Major cardiac events /cardiac death, reMI,     rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up Rate of composite     angiographic adverse events including: distal embolisation, transient no-reflow or slow flow,     final TIMI <3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside, final     thrombus score >1   "
193501|NCT00377663|"     Asthma is a respiratory condition that affects millions of children. It can be controlled,     however, with the proper medications and treatment. AsthmaNet, an internet-based asthma     management system, aims to improve the asthma care of children by providing their parents and     doctors with appropriate tools and feedback related to asthma management. The purpose of this     study is to evaluate the effectiveness of AsthmaNet at improving quality of care and     controlling asthma symptoms in children.   "
193519|NCT00377897|"     This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not     eligible for revascularization or angioplasty. It will use exactly the same protocol as     published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells     (BMMNC).   "
193502|NCT00377676|"     Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces     blood sugar by the proposed mechanism of reversing many of the metabolic alterations     associated with insulin resistance and obesity by resetting central (hypothalamic) circadian     organization of monoamine neuronal activities.      The primary analysis of this study will test the hypothesis that the rate of all-cause severe     adverse events for those receiving usual drug therapy for diabetes management plus Cycloset     is not greater than that for usual drug therapy plus placebo by more than an acceptable     margin. While the primary purpose of this study is to establish the safety profile of     Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated     as well.   "
193503|NCT00377689|"     The purpose of this study is to evaluate a 5-week intervention program targeted at improving     balance and functional skills for people with stroke.   "
193504|NCT00377702|"     Cardiovascular disease (CVD) is one of the leading causes of death in the United States.     Currently, there is little information about the lifetime risk of CVD among non-white ethnic     groups. This study will analyze data from participants in several ongoing clinical studies to     identify the lifetime risk for CVD among various ethnicities.   "
193505|NCT00377715|"     This study will evaluate the safety and potential benefit of Dimebon as compared to placebo     in patients with mild to moderate Alzheimer's Disease.   "
193506|NCT00377728|"     This study is in patients with seasonal allergic rhinitis(SAR)and will compare the effect     versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber.     GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in     development by GSK for the treatment of allergic rhinitis, asthma and COPD.      Subjects will be selected on the basis that they display a defined moderate response to the     pre-determined dose used. Opportunity to assess the efficacy of compounds versus placebo at     maximal and trough plasma concentrations.      This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients     with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.      12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal     examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge     assessments will also be performed at various time points throughout the study.   "
193507|NCT00377741|"     This study will assess the relative bioavailability of ganciclovir from the pro-drug     valganciclovir in lung transplant recipients with or without cystic fibrosis. Each patient     will receive 900mg valganciclovir daily for the period specified at their center, starting as     soon as possible after the transplant. Pharmacokinetic assessments will be made provided that     steady-state kinetics of ganciclovir and immunosuppressive drugs have been obtained (>=4 days     of drug therapy). Blood samples for pharmacokinetic analysis will be taken up to 24h     post-dose on one occasion. The anticipated time on study treatment is 3-12 months, and the     target sample size is <100 individuals.   "
193508|NCT00377754|"     Dengue is a common disease and a major health concern in the Philippines. Dengue is caused by     a virus transmitted from the bite of an infected mosquito. The purpose of this study is to     understand why some infants remain well or have a mild illness, and why other infants become     very sick from this virus. Studies have shown that the mother's immune response to dengue can     play a role in the infant's immune response and affect whether or not the infant becomes     sick. This study will enroll up to 10,000 healthy infants 6-14 weeks old and their mothers in     San Pablo City. At the first study visit, information about the mother and birth will be     collected and blood samples will be taken from the mother and infant. The infant will have     blood drawn at all 3 study visits. The infants will be followed until the age of 16 months.     The information obtained from this study may help in the development and future testing of a     safe and effective dengue vaccine.   "
193509|NCT00377767|"     To determine the extent to which a clinical intervention based on the Chronic Care Model     (CCM), compared with the usual care control condition, results in a smaller age-associated     increase in body mass index (BMI) over a 1 year intervention (primary outcome) and a 1     1/2-year follow-up period.   "
193510|NCT00377780|"     This is an open phase II study evaluating the efficacy and safety of the non pegylated     liposomal doxorubicin (Myocet®), trastuzumab (Herceptin®), and docetaxel (Taxotere®)     combination as first-line treatment of patients with metastatic HER2/neu positive breast     cancer.   "
193511|NCT00377793|"     This trial is to provide additional important information on the impact of the treatment of     the man its ED with vardenafil on partnership. This study is being run at up to 50 study     centers in Europe and South Africa to evaluate the use of vardenafil in adult men with     erectile dysfunction (often called impotence), and their female partner's sexual quality of     life. Many men experience occasional erectile problems during their lives. However, when this     becomes a continued problem, it can affect both the man and his female partner. The causes of     erectile dysfunction are varied and may be due to physiological or emotional reasons. This     study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether     treating a man its erectile dysfunction with vardenafil will improve his female partner its     sexual quality of life. The second part (week 12) of the study (Educational program) a     subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an     educational program concerning ED in the from of a DVD.   "
193512|NCT00377806|"     This study will assess the efficacy, safety and tolerability of topically administered     diclofenac gel versus placebo with respect to the symptom score (pain, temperature and size     of erythema along the superficial vein)   "
193513|NCT00377819|"     The study will evaluate the efficacy and safety of transitioning postmenopausal women on     current alendronate therapy to denosumab. Endpoints studied will include bone mineral     density, bone turnover markers and bone histology in a subset of subjects.   "
193514|NCT00377832|"     The most common cause of fetal tachycardia is maternal fever. Fetal tachycardia often     precedes the maternal fever, and fetal tachycardia confounds the interpretation of electronic     fetal monitoring (EFM), increasing the rate of cesarean delivery for non-reassuring fetal     status (NRFS). Our hypothesis is that treatment of fetal tachycardia with acetaminophen will     significantly lower maternal body temperature and significantly lower baseline fetal heart     rate (FHR). The importance is that interpretation of EFM will improve, thus allowing for a     decrease in cesarean delivery for NRFS.   "
193520|NCT00377910|"     Chronic achilles tendinopathy is a common disease especially in adults. The golden standard     in treatment has up to now been excentric exercises but with varying success. A new     hypothesis is that this chronic pain is due to neo vascularisation. In a pilot study     sclerosing injections with polidocanol have had a successful efficacy. Our aim is to study     the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger     scale.   "
193521|NCT00377923|"     This is a multiple dose, observer blind, randomised, parallel groups pharmacodynamic and     pharmacokinetic study to assess the endometrial effects (predecidual changes) of a new     aqueous progesterone formulation administered s.c. at the dose of 25 and 50 mg/day.   "
193522|NCT00377936|"     The intention of this trial is to evaluate safety and efficacy of a combination treatment of     EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.   "
193523|NCT00377949|"     The purpose of this study is to determine the timeline of progression from pre-pulmonary     hypertension to diagnosable pulmonary hypertension based on right heart catheterization.     Moreover, to determine the timeline for progression from diagnosable pulmonary hypertension     to clinical worsening of disease as defined as death, hospitalization, or worsening of PHT     symptoms.   "
193524|NCT00377962|"     This study investigated whether initiation of everolimus together with reduction of     calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal     impairment would improve renal function.   "
193525|NCT00377975|"     This study compares four treatments to see which one causes the most weight loss, fat loss,     loss of abdominal fat and improvement in blood tests like cholesterol. The four treatments     are: Placebo, Ephedrine plus caffeine, Pioglitazone, Combined pioglitazone and ephedrine plus     caffeine   "
193526|NCT00377988|"     The purpose of the study is to use data from a health care information database to assess the     risk of venous thromboembolism (blood clots), myocardial infarction (heart attacks), and     stroke among women using a transdermal contraceptive system (ORTHO EVRA) for birth control     compared with women using norgestimate-containing oral contraceptives with 35 mcg ethinyl     estradiol.   "
193527|NCT00378001|"     The purpose of the study is to evaluate the clinical efficacy and general tolerability of two     different subcutaneous FSH preparations (Fostimon®, IBSA vs Gonal-F®, Serono Inc.) when     administered to patients undergoing controlled ovarian stimulation for IVF.   "
193528|NCT00378014|"     The study is designed to show that everolimus initiation together with reduction and     thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal     function in de novo liver transplant recipients as compared to continuation of CNI-based     treatment.   "
193529|NCT00378027|"     To assess the safety and efficacy of outpatient treatment using fondaparinux and oral Vit K     antagonist, warfarin (Coumadin) in patients with stable acute pulmonary embolus (APE)when     initial therapy is administered in the hospital. Prospectively validate risk stratification     criteria for predicting patient suitability for outpatient treatment of acute pulmonary     embolism.   "
193530|NCT00378040|"     It is hypothesized that patients with vascular disease are undertreated for modifiable risk     factors, leading to increased morbidity and mortality in this population.      The objective of this study is to develop a comprehensive database that will demonstrate the     current adequacy of risk factor management in this high risk population, and that will     provide needed guidance for future treatment options.   "
193531|NCT00378053|"     The purpose of this study is to measure the amount of radiation over a specific period of     time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine.   "
193532|NCT00378066|"     The purpose of this study is to determine the efficacy and safety of     bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal     cancer.   "
193533|NCT00378079|"     This five-year study examines the benefits of methadone maintenance treatment initiated in     prison and continued in the community to male offenders who were previously, but not     currently, heroin-dependent. It is anticipated that such prisoners will have more favorable     outcomes in the year following release with regard to drug abuse, crime, and HIV risk     behavior than either prisoners who receive counseling only or begin initiation of methadone     maintenance in the community   "
193534|NCT00378092|"     The purpose of this study is to evaluate the outcome of medication discontinuation, the     safety and effectiveness of re-initiating risperidone long acting injection (RLAI) in case of     relapse (the return of a medical problem) of schizophrenia (psychiatric disorder with     symptoms of emotional instability, detachment from reality, often with delusions and     hallucinations, and withdrawal into the self) during the study observation period of 36     months.   "
193535|NCT00378105|"     The purpose of this study is to determine the safety and efficacy of the bortezomib,     lenalidomide and dexamethasone combination in patients with newly diagnosed multiple myeloma.     We are looking for the highest dose of the combination that can be given safely and see how     well it works as a combination in newly diagnosed patients.   "
193536|NCT00378118|"     Blood is the most commonly used specimen to test for HIV. In the past 20 years, use of saliva     as an alternative specimen for HIV testing has been explored. Today, very sensitive tests     have been formulated and have been used for diagnosing HIV in adults and older children.     OraQuick, a rapid test, is one such example. It is a devise that can be used to collect as     well test the saliva.      Most studies done on the use of saliva have been carried out in adults and have produced very     good results. However very few such studies have been done in children, especially infants.     In adults, use of saliva has also highlighted the advantages of ease of collection and     increased acceptability of testing.      HYPOTHESIS OraQuick rapid test can detect antiHIV antibodies as well as the Abbott determine     test and oral fluid testing is more acceptable than blood testing.   "
193537|NCT00378131|"     Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by     virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role     in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will     evaluate the safety and efficacy of RC-1291 HCl in cancer patients with cachexia.   "
193709|NCT00380510|"     The study examines (1)the incidence of preventive health services provided by family     physicians to adolescent patients, and (2)barriers and facilitators of prevention discussions     between family physicians and their adolescent patients.   "
193538|NCT00372541|"     Acute lower respiratory tract infections are a leading cause of morbidity and mortality in     sub Saharan Africa. The World Health Organisation (WHO) still recommends intravenous     chloramphenicol for the treatment of severe pneumonia in children aged less than five years.     However, up to 20% of children fail treatment due to the emergence of resistance by bacteria.     Several centers now use ceftriaxone, a third generation cephalosporin, which is reported to     be efficacious in the treatment of severe pneumonia. However the high cost of ceftriaxone is     too prohibitive to allow for its routine use in resource constrained countries. The purpose     of this study is to compare chloramphenicol and ceftriaxone in the treatment of severe     pneumonia in children under five.      We hypothesize that 92.7% of children who receive once daily intravenous ceftriaxone (75     mg/kg body weight)for 7 days, will recover from severe pneumonia compared to 80.2 % of those     who receive intravenous chloramphenicol (25mg/kg body weight/dose every 6 hours for 7 days).   "
193539|NCT00372567|"     A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive     disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5     mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side     effects of taking sunitinib or imatinib for approximately one year.   "
193540|NCT00378144|"     The purpose of this study is to investigate the efficacy and safety for a marketed sinus     allergy product, Sinutab, in the treatment of nasal congestion and headache.   "
193541|NCT00378157|"     The purpose of this study is to investigate the effectiveness of an intervention aimed to     increase joint attention in 2-4 year old children with autism. The study will be conducted in     mainstream preschools in Norway. The intervention will be implemented by preschool teachers     and paraprofessionals supervised by trained counselors.   "
193542|NCT00378170|"     The primary objective is to evaluate a knewly developed blade (for intubating patients about     to undergo surgery) and compare it to the traditional Macintosh blade   "
193543|NCT00378183|"     The purpose of this study is to compare three strategies for switching patients with     schizophrenia or schizoaffective disorder to the atypical antipsychotic, risperdone, after     they have been unsuccessfully treated with another atypical antipsychotic, olanzapine. In the     second phase of this study, investigators will assess the effectiveness of behavioral therapy     in reducing body weight in risperdone-treated patients who are overweight or have problems     with diabetes or blood sugar.   "
193544|NCT00378196|"     This research is being done to look at the effects of an experimental drug, ranibizumab, for     the treatment of a condition called idiopathic parafoveal telangiectasia or IPT. IPT is     caused by swelling in the retina (the light sensitive tissue in the back of the eye) due to     leaky blood vessels in this area. Swelling in the retina can lead to blurry vision.   "
193545|NCT00378209|"     The purpose of this study is to evaluate the effectiveness and side effects of the     bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory     multiple myeloma. Each of these drugs are approved by the U.S Food and Drug Administration,     but have not been approved in the combination for treating patients in this setting.   "
193546|NCT00378222|"     The present study was designed in an attempt to prospectively evaluate in a randomized     fashion whether further cytotoxic dose intensification, as delivered with two sequential     autologous stem-cell transplantations, improved the outcome of younger patients with newly     diagnosed multiple myeloma in comparison with a single autologous transplantation.   "
193547|NCT00378235|"     IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a     bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a     variety of IL13-receptor positive tumor cell lines indicating that it may show a therapeutic     benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the     IL13 receptors was shown to be highly specific for human glioma cells.   "
193548|NCT00378248|"     Ullevål PersonalityProject is a ranomized controlled trial of treatment of patients with     personality disorder. It's main purpose is to test the effect of a long-term combined     treatment program compared with eclectic individual therapy for patients with personality     disorders.      The main study hypothesis is that long-term combined treatment is superior to eclectic     individual therapy with respect to improvement in personality functioning, psychosocial     functioning, symptoms, interpersonal problems, and self destructive behavior for poorly     functioning patients with personality disorders.   "
193549|NCT00378261|"     The purpose of this study is to evaluate the utility of an electronic data capture system     (EDCS) in a rheumatology clinical practice setting and to assess the impact of this system on     patient satisfaction with patient-physician interaction.   "
193550|NCT00378274|"     The purpose of the study is to investigate pain, anxiety and depression in chronic pain     patients with and without neuropathic pain compared with healthy volunteers   "
193551|NCT00378287|"     The purpose of the study is to demonstrate in patients that oral rabeprazole produces     equivalent acid suppression to intravenous pantoprazole on Day 1 of drug administration.   "
193552|NCT00378300|"     The purpose of this study is to study the clinical effects of taking probiotics in patients     who have moderate to severe atopic dermatitis. There has been several studies showing     improvement in the severity of atopic dermatitis after taking probiotics. The mechanism of     this improvement is currently unknown. We propose that probiotics improve atopic dermatitis     by stimulating, or increasing, the activity of a special type of cell called the T Regulatory     cell--which can suppress the activity of allergic disease.   "
193553|NCT00378313|"     The primary purpose of this study is to determine whether locally advanced breast cancer     responds (by shrinking, by not progressing or by being destroyed) to combined chemotherapy     (gemcitabine, epirubicin and paclitaxel) given before surgery to patients with locally     advanced breast cancer. This study will also evaluate the toxicity of the chemotherapy     combination to patients and will determine survival and progression-free survival 2 years     after treatment. Also, the study will look at whether there are molecular and genetic changes     in the tumor tissue that match the tumor's response to the chemotherapy.   "
193567|NCT00378625|"     The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine     in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in     Colombia. The benefit will be assessed in terms of:        -  Efficacy        -  Tolerability        -  Time of fever clearance        -  Time of parasite clearance        -  Proportion of gametocyte carriers   "
193554|NCT00378326|"     We treat a subset of patients with paraneoplastic neurologic disorders, including those with     Yo-mediated paraneoplastic cerebellar degeneration (PCD), the Hu syndrome, which is most     commonly associated with small cell lung cancer (SCLC) - paraneoplastic subacute sensory     neuropathy, encephalomyelitis, limbic encephalopathy, autonomic neuropathy - and the Ri     Syndrome (a.k.a. Paraneoplastic Opsoclonus-Myoclonus Ataxia), as well as those patients     suspected to have a paraneoplastic neurologic disorder but in whom a characteristic antibody     has not yet been identified. Our treatment protocol consists of immune suppression therapy     using tacrolimus (FK506), a potent inhibitor of lymphocyte proliferation that is commonly     used to prevent organ transplant rejection.   "
193555|NCT00378339|"     Gold implantation around arthritic joints is a very popular treatment - but the effect has     never been controlled.   "
193556|NCT00378352|"     The purpose of this study is to evaluate whether erythropoietin can help limit the damage to     the heart in patients with acute heart attacks.   "
193557|NCT00378365|"     To assess the role of Arsenic trioxide and/or ATRA during consolidation course in APL. It is     hoped that the investigational arms will further increase the event-free survival at 2 years,     with reduced toxicity and without increasing the relapse rate by comparison with a classical     anthracycline-AraC consolidation regimen.   "
193558|NCT00378378|"     The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone     Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the     ages of 6 and less than 18 years old. Safety will be the primary focus of this study.   "
193559|NCT00378391|"     EUROTRANSFER Registry is a prospective, international, web-based European Registry on     Patients with ST-Elevation MI Transferred for Mechanical Reperfusion (PCI) with a Special     Focus on Upstream Use of Abciximab.      This registry is designed to collect data on approximately 1800 patients during a 12 month     enrollment period in up to 20 interventional cardiology centres with hospital transfer     networks from all over Europe.      Analysis of this registry should allow to monitor transfer timelines of patients arriving to     the cath-lab from the regional hospital with or without upstream start of abciximab and     scheduled for mechanical reperfusion (PCI) as well as to monitor regional differences across     Europe in regard to the impact that time of various stages of the treatment chain may have on     clinical outcomes.   "
193560|NCT00378404|"     The purpose of this study is to assess the maximum tolerated dose of low-dose radiation in     combination with Docetaxel in recurrent or metastatic non-small cell lung cancer for     second-line therapy.   "
193561|NCT00378417|"     This was a randomized, double-blinded multicenter cohort study of Finnish children aged 2 to     24 months. The study was designed to evaluate the efficacy of two 7-valent pneumococcal     conjugate vaccines (PncCRM and PncOMPC) parallelly, both vaccines compared with the same     control vaccine (hepatitis B vaccine).      The primary endpoint was culture-confirmed pneumococcal acute otitis media (AOM) episodes due     to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis     was that, compared to the control vaccine group, the pneumococcal conjugate vaccine would     protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine.     The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated.      The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine     at the age of 2, 4, 6 and 12 months and followed at study clinics established specifically     for the purpose from 2 to 24 months of age. Whenever AOM was diagnosed during the follow-up,     middle ear fluid was aspirated for bacterial culture.   "
193562|NCT00378430|"     Aim - To better understand expectations and attitudes of first generation immigrants from     India to USA.      Background - The is large difference in healthcare system as practiced in India and in USA.     Most people who have lived in India for certain period of their life have basic understanding     of health-care system in India. In general it is the physician who makes choices for patients     there , also the concept of health screening is less prevalent. After immigrating to USA     these immigrants are exposed to new healthcare system. We donot have any data showing their     attitudes to some specific questions and physician preference in general. We also have     significant concentration of these ethnic group in the central valley.      With this questionnaire study we hope to get better understanding of their beliefs and     expectations. We have tried to keep the questions simple and straightforward.   "
193563|NCT00378443|"     IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the     etiology of the disease is not clearly understood, no specific therapeutic strategies was     defined for IgAN. Both ACEi/ARB and steroid was found to be effective in slowing the rate of     disease progression, but the use of steroid was restricted because of its side effects.     However, there is no evidence from RCT on the question of whether combined use of steroid     with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore     undertook a randomized, multicenter study to investigate the efficacy and safety profile of     combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of     patients with IgAN.   "
193564|NCT00378456|"     The trial aimed to examine the effects of supplementation with antioxidants and folinic acid     on the health, growth and psychomotor development of children with Down syndrome. 156     children with Trisomy 21, less than 7 months of age were recruited and randomised into four     groups to receive antioxidants, folinic acid, a combination of antioxidants and folinic acid     or a placebo. Blinded outcome assessment was carried out 18 months later.Blood and urine     samples were also taken around 12 months of age to examine metabolic effects of     supplementation.   "
193565|NCT00378469|"     The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in     healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45     minutes, and urine and blood samples will be collected regularly to measure hemojuvelin,     hepcidin, iron and transferrin levels.   "
193566|NCT00378612|"     ACROSS-Cypher® is a prospective, multi-center, open label, single arm study of the Cypher®     sirolimus eluting coronary stent in native total coronary occlusion revascularization. The     primary endpoint is binary angiographic restenosis at 6 months. The TOSCA-1 trial will be     used as the historical control. The hypothesis is that compared with TOSCA-1 patients who     were treated with the heparin-coated Palmaz Schatz stent, treatment with the Cypher®     sirolimus eluting coronary stent will result in a >50% relative reduction in 6 month     restenosis within the treated segment of the target vessel.   "
193568|NCT00378638|"     This research focuses on women with breast cancer whose disease has not significantly     progressed, but who have 5 or more lymph nodes involved. In this study subjects will receive     bevacizumab, a drug which is FDA approved for colon cancer but not for breast cancer, in     combination with a regimen of approved chemotherapy drugs known as dose dense chemotherapy.     The study will observe the effectiveness and tolerability of this regimen.   "
193569|NCT00378651|"     This study is intended to validate the use of neck auscultation with an electronic     stethoscope during intubation to confirm tracheal tube placement.      It is hypothesized that the ability to confirm correct tube placement with this technique     will be similar to that of the end-tidal CO2 monitor, the current gold-standard device for     confirming tracheal intubation.   "
193570|NCT00378664|"     To assess the level of improvement in voiding function after lumbar to sacral ventral nerve     re-routing procedure in Spinal Cord Injury and spina bifida patients   "
193571|NCT00378677|"     The purpose of this study is to investigate whether dry powder inhalation of Cyclosporine A     is beneficial in lung transplant patients with Bronchiolitis Obliterans Syndrome. For     patients suffering from this syndrome often no therapeutic options are available.     Furthermore, the side effects of the maintenance therapy leaves no room for dose increments.     The hypothesis for this trial is that when Cyclosporine A is administered locally (in the     lungs) chronic rejection can be treated more effectively without extra systemic side effects.   "
193572|NCT00378690|"     Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase     for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with     hormone responsive prostate cancer will be randomized and will receive either intermittent or     continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will     enter a long-term follow-up period for 48 months.   "
193573|NCT00378703|"     This randomized phase II trial studies different combinations of bevacizumab, temsirolimus,     and sorafenib tosylate to see how well they work compared with bevacizumab alone in treating     patients with kidney cancer that has spread to other places in the body. Monoclonal     antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and     spread. Bevacizumab and sorafenib tosylate may stop the growth of tumor cells by blocking     blood flow to the tumor. Temsirolimus and sorafenib tosylate may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving different combinations     of bevacizumab, sorafenib tosylate, and temsirolimus may be more effective than bevacizumab     alone in treating metastatic kidney cancer.   "
193574|NCT00378716|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug is a way to kill more tumor cells.      PURPOSE: Randomized phase III trial to determine the effectiveness of uracil, tegafur,and     leucovorin compared with fluorouracil plus leucovorin in patients with resected stage II or     stage III colon cancer.   "
193575|NCT00378729|"     PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of     infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of     failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with     Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical     treatment could be associated to surgical complications, and medical treatment could be     associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.      The aim of this study is to compare the two treatments to demonstrate the equivalence of     efficacy and the diminution of multiple pregnancies by the surgical treatments. After an     ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical     treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian     hyperstimulation and IUI if the sperm is normal   "
193576|NCT00378742|"     This study will collect blood and DNA samples from patients with inherited eye diseases to be     used in research to identify genetic factors responsible for these conditions. In recent     years, nearly 500 genes that contribute to inherited eye diseases have been identified.     Disease-causing mutations are associated with many eye diseases, including glaucoma,     cataracts, strabismus, corneal dystrophies and a number of forms of retinal degenerations. As     a result, gene-based therapies are being pursued to treat eye genetic diseases that were once     considered untreatable.      The National Ophthalmic Genotyping Network (eyeGENE ) is creating a national tissue     repository to further advance genetic research on inherited eye disease, while at the same     time providing clinically-useful information back to patients and physicians who request it..     Physicians in collaborating institutions will recruit patients to participate in the study.     Patients will provide a blood sample and undergo a standard eye examination. The blood sample     and clinical information will then be sent to the NEI for testing, processing and storing in     the tissue repository. Patients are given the option to receive results back and/or to be     re-contacted in the event of future clinical studies. Information supplied to the testing     laboratories includes a unique identification number, the patient gender, and the patient     date of birth. The stored samples will be made available to researchers along with     information about the patient's disease, but without patient identifiers.   "
193577|NCT00378755|"     1. Primary Objective To assess the response rate of sequential VAD (Vincristine,          Adriamycin, Dexamethasone) and VTD (Velcade, Thalidomide, Dexamethasone) induction          therapy as a first line treatment for the patients with multiple myeloma        2. Secondary Objectives             1. To assess the progression free survival, duration of response, and overall survival               of patients given sequential VAD and VTD induction followed by high dose therapy               with autologous stem cell transplantation and maintenance treatment with Velcade             2. To assess the toxicities of sequential VAD and VTD induction chemotherapy, high               dose therapy with autologous stem cell transplantation, and of maintenance               treatment with Velcade.   "
193578|NCT00378768|"     RATIONALE: Biological therapies, such as antithymocyte globulin, may stimulate the immune     system in different ways and stop cancer cells from growing.      PURPOSE: This phase II trial is studying how well antithymocyte globulin works in treating     patients undergoing stem cell transplant for multiple myeloma.   "
193610|NCT00379210|"     The purpose of this study is to examine behavioral and neural changes resulting from     Mindfulness Meditation Training (MMT), and to use this knowledge in advancing our     understanding of the mechanisms of attention.   "
193710|NCT00380523|"     Allow physicians to test the efficacy of arcoxia in patients with acute pain.   "
193579|NCT00378781|"     RATIONALE: Heparin or M-EDTA may prevent catheter-related infections and blockages in     patients at high risk for a catheter-related infection. It is not yet known whether heparin     is more effective than M-EDTA in preventing catheter-related infections and blockages in     patients at high risk for a catheter-related infection.      PURPOSE: This randomized clinical trial is studying heparin to see how well it works compared     with M-EDTA in preventing catheter-related infections and blockages in patients at high risk     for a catheter-related infection.   "
193580|NCT00378820|"     It is not clear which milk compounds are responsible for the growth stimulation. Through     short term intervention studies in prepubertal children, we will test the effects of whey,     casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids,     oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and     markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase,     urine Dpyr, Ntx) as well as blood pressure.   "
193581|NCT00378833|"     This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is     appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There     will be 6 scheduled clinic visits and 2 treatment groups.   "
193582|NCT00378846|"     RATIONALE: Comparing results of three different thermometers used to measure body temperature     may help doctors find the most accurate thermometer to detect fever and plan the best     treatment.      PURPOSE: This clinical trial is studying three different types of thermometers to measure     temperature in young patients with fever and without fever.   "
193583|NCT00378859|"     The objective of the study is to examine whether a 7-day high protein intake from either milk     or meat in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3     and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell     function and amino acids.   "
193584|NCT00378872|"     We will compare the effectiveness of Quixil and Tranexamic acid in reducing bleeding during     hip and knee joint replacements.   "
193585|NCT00378885|"     The purpose of this study is to examine the efficacy of a theory based, online tailored     intervention on stimulating safe-sex practices among men who have sex with men (MSM). Our     hypothesis was that a tailored internet intervention would be more effective in stimulating     safe-sex practices of gay men than a non-tailored internet intervention when compared to a     waiting-list control group.   "
193586|NCT00378898|"     Assessing the feasibility and patient tolerance to placement of Bravo PH capsule in proximal     esophagus.      There will be no difference in patient-perception of a proximally-placed Bravo esophageal pH     monitor compared with a distal monitor.   "
193587|NCT00378911|"     This phase II trial is studying how well sunitinib works in treating patients with recurrent     or persistent leiomyosarcoma of the uterus. Sunitinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
193588|NCT00378924|"     Statement of the Problem:      Over the last several decades, scientists have made great progress in their understanding of     cardiovascular disease. Nevertheless, much remains to be learned about the causes, course,     and treatment of cardiovascular disease. In order to learn more about this topic, it is     important to establish large databases of cardiovascular patients. These databases allows     scientists to investigate, in a rigorous and precise manner, those factors that influence     cardiovascular disease.      How the Problem Will Be Studied:      In the present study, we intend to establish a large database of cardiovascular patients.     More specifically, we will create a database of approximately 12,000 cardiac catheterization     and heart failure patients from Emory University Hospital, the Emory Clinic, Crawford Long     Hospital, and Grady Memorial Hospital.      We will collect a large amount of data on these patients. Data to be collected will include     information on:        1. medical history of the patient        2. medical history of the patient's family        3. health behaviors of the patient        4. psychological status of the patient        5. results of procedures the patient undergoes, such as catheterization/angioplasty/bypass        6. biochemical markers in patient blood samples, including genetic/DNA markers        7. follow-up information on patient outcomes such as mortality or re-hospitalization      The data noted above will be collected by:        1. administering questionnaires/interviews to the patients        2. accessing the medical records of the patients        3. collecting blood samples from patients which will be analyzed by laboratories for their          biochemical content.      Once the data has been collected, we will run a variety of statistical analyses to which will     help us to learn more about the factors that cause various cardiovascular diseases such as     coronary heart disease, angina, heart failure, hypertension, and stroke. The statistical     analyses will also help us to understand how these diseases can be treated more effectively.      How the Research Will Advance Scientific Knowledge/Human Health:      By collecting a large amount of data on a large number of cardiovascular patients, we will be     able to analyze, with a great deal of precision, those factors that influence the onset,     course, and treatment of cardiovascular disease. The results of these precise analyses can     then be used to help optimize clinical efforts to prevent and treat cardiovascular disease.   "
193589|NCT00378937|"     RATIONALE: Oxycodone helps lessen pain caused by cancer and may improve quality of life. It     is not yet known whether oxycodone works better and is more cost effective than standard     therapy in treating patients with cancer pain.      PURPOSE: This randomized phase IV trial is studying oxycodone to see how well it works     compared with standard pain therapy in treating patients with cancer pain and if it is more     cost effective than standard pain therapy.   "
193590|NCT00378950|"     Heart failure (HF) affects 5 million people in the United States. Health literacy, which is     the ability to read and comprehend important medical information, plays an important role in     the health of individuals with HF. This study will evaluate the effectiveness of an     educational program developed for various levels of health literacy at improving medical     outcomes and quality of life in individuals with HF.   "
193591|NCT00378963|"     The purpose of this study is to determine the affects of instrumental and manual manipulation     on the EMG response of asymptomatic subjects.   "
193592|NCT00378976|"     Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical     and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The     evidence suggests that that HSV is an important cofactor in HIV transmission.      The trial's purpose is to assess the reduction in HIV shedding associated with valacyclovir     for suppression of HSV-2 reactivation.      This proof-of-concept, randomized, double-blind, placebo controlled crossover trial of 20     HIV/HSV-2 co-infected men, assessed the effects of daily valacyclovir on HIV-1 levels in the     plasma and rectal mucosa secretions.   "
193593|NCT00378989|"     Study hypotheses were 1) Classification of the risk of sickness absence can be made with     questionnaires addressing self-rated health problems; 2) Occupational health intervention of     the employees at `High Risk´ of sickness absence is more effective than usual care in     controlling sickness absence; 3) Health advice intervention of the employees at `Increased     Risk´ of sickness absence is more effective than usual care in controlling sickness absence;     4) The interventions are cost-effective use of resources from the societal perspective.   "
193594|NCT00379002|"     Comprehensive database from the Women's Urology Center/WISH (Women's Initiative for Pelvic     Pain and Sexual Health) program at Beaumont.   "
193595|NCT00379015|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and docetaxel,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Giving     chemotherapy and a monoclonal antibody before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving epirubicin and cyclophosphamide     followed by docetaxel and trastuzumab works in treating women with HER2-positive stage IIIB,     stage IIIC, or stage IV primary breast cancer.   "
193596|NCT00379028|"     The purpose of the study is to evaluate how the airways in COPD patients, compared to healthy     volunteers, absorb steroid drugs from Symbicort Turbuhaler and Seretide Diskus. The blood     concentrations of the steroids will be used as surrogate marker.   "
193597|NCT00379041|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving radiation therapy together with combination     chemotherapy may kill more cancer cells. It is not yet known whether radiation therapy is     more effective with or without combination chemotherapy in treating patients with Hodgkin's     lymphoma.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works with or without combination chemotherapy in treating patients with previously untreated     stage I or stage II Hodgkin's lymphoma.   "
193598|NCT00379054|"     This study will examine the feasibility and potential effectiveness of an intervention for     adults who want to help support a smoker to quit. The support persons will receive either     self-help materials only or the self-help materials plus a telephone counseling intervention.     Both interventions provide information on how support persons can encourage a smoker to quit.   "
193599|NCT00379067|"     Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS     0.4 mg & placebo). The study comprises a 2-week placebo run-in followed by a 12-week     treatment period.   "
193600|NCT00379080|"     This phase I/II trial is studying the side effects and best dose of tandutinib and to see how     well it works in treating patients with recurrent or progressive glioblastoma.Tandutinib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by     blocking blood flow to the tumor.   "
193601|NCT00379093|"     Older persons who drink can be vulnerable to negative consequences of drinking. This trial     aims to prevent harm from alcohol use in older adults through a program of screening and     brief advice followed up with several health education phone calls.   "
193602|NCT00379106|"     To measure arm function and quality of life of mastectomy patients.   "
193603|NCT00379119|"     RATIONALE: Studying changes in thymus function in patients who have been undergoing androgen     blockade therapy for prostate cancer may help doctors learn more about how well patients will     respond to treatment, may help in planning cancer treatment, and may help the study of cancer     in the future.      PURPOSE: This clinical trial is studying the effect of androgen blockade therapy on thymus     function in older patients who have undergone radical prostatectomy for localized prostate     cancer.   "
193604|NCT00379132|"     This study is designed to evaluate the ability of intravenously (IV)administered     131-I-labeled TM-601 (chlorotoxin) to provide tumor-specific localization(via radiographic     imaging) in patients with recurrent or refractory primary solid tumors with evidence of     metastatic involvement. (Refractory tumors are non-responsive to standard treatment.) The     safety and tolerability of IV administered 131-I-TM-601 in this patient population will be     evaluated as part of this study.   "
193605|NCT00379145|"     RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with     advanced, persistent, or recurrent leiomyosarcoma of the uterus.   "
193606|NCT00379158|"     1. At 12 mo of age, all three intervention groups will have significantly better iron and          vitamin A status than the NI group.        2. Infants who receive the Foodlet or Nutributter will have significantly greater weight          and length gains from 6 to 12 mo and higher indices of vitamin B6, riboflavin and zinc          status at 12 mo of age than the infants who receive the sprinkles containing iron and          vitamin A only.        3. Infants who receive Nutributter will have significantly greater weight and length gains          from 6 to 12 mo and higher indices of vitamin A and essential fatty acid (linoleic,          alpha-linolenic and docosahexaenoic, DHA) status at 12 mo of age than the infants who          receive the Foodlet or sprinkles.   "
193607|NCT00379171|"     The objective of this intervention study is to examine the effect of whole cow's milk versus     infant formula as primary milk sources with or without supplements of n-3 LCPUFA for growth,     nutritional status, development, risk factors for later diseases and the impact on the     intestinal microbiota and inflammation in 9 - 12 months old infants.   "
193608|NCT00379184|"     Musculoskeletal pains represent a major part of pain complaints in patients. Moreover, the     treatment of musculoskeletal pain conditions by currently available drugs is not optimal     (Curatolo and Bogduk 2001). Thus, deep pain is a diagnostic and therapeutic problem, and     further insights into the peripheral and central neurophysiologic mechanisms are necessary to     improve diagnosis and therapy and to implement a mechanism-based approach. Peripheral     sensitization and central hyper excitability are, most likely the important factors for     chronic musculoskeletal pain and in particular osteoarthritis (OA).      The focus of this project is to study the involvement of peripheral and central sensitization     underlying deep tissue hyperalgesia and referred pain in male and female OA patients.      Adequate quantitative sensory testing assessment techniques for measuring hyper excitability     are needed to investigate, in more detail the mechanisms involved in generating the     sensitization in OA patients.   "
193609|NCT00379197|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Naltrexone may fight breast     cancer by blocking the use of estrogen by the tumor cells. Naltrexone may also stop the     growth of breast cancer by impairing blood flow to the tumor.      PURPOSE: This phase II trial is studying how well naltrexone works in treating women with     metastatic breast cancer that is no longer responsive to previous hormone therapy.   "
193611|NCT00379223|"     Natural evolution of severe central retinal vein occlusion with low visual acuity is very     poor. A randomized clinical trial will compare troxerutin and platelet anti-aggregating     agents (drug treatment) versus surgery and drug treatment. Surgery will include vitrectomy     and radial optic neurotomy. The primary outcome will be vision measured 6 months after     surgery.   "
193612|NCT00379236|"     This multicenter, randomized, double-blind study will be performed in approximately 600     subjects with chronic idiopathic osteoarthritis (OA) of the knee. An open-label safety     extension will follow.   "
193613|NCT00379249|"     The primary objective of the study is to compare the effect of rosuvastatin therapy plus     compliance initiatives and rosuvastatin therapy alone for 12 months (52 weeks) on long-term     cumulative direct and indirect disease-related costs during the 36 month.   "
193614|NCT00379262|"     The objectives of this clinical study are threefold:        1. To compare the benefits in cancer control and survival obtained from adding          induction-concurrent chemotherapy to radiation with those from adding          concurrent-adjuvant chemotherapy to radiation.        2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the          chemotherapy plan will maintain or improve further the chemotherapy benefits while          reducing the duration of hospital stay.        3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as          compared with conventional fractionation radiotherapy.   "
193615|NCT00379275|"     This study will evaluate patients with sarcoidosis to understand how the disease affects the     body. Sarcoidosis is a disease that results from inflammation of body tissues. The lungs,     lymph nodes in the chest, skin and eyes are most commonly affected. As the disease     progresses, small lumps, or granulomas, appear in the affected tissues. In most cases, the     granulomas clear up, but in cases where they do not heal and disappear, the tissues tend to     remain inflamed. Eye inflammation (uveitis) associated with sarcoidosis can cause various eye     diseases, sometimes leading to blindness. This study will examine the clinical, immunological     and genetic features of ocular sarcoidosis.      Patients 6 years of age and older with sarcoidosis may be eligible for this study. Candidates     are screened with the following procedures:        -  Completion of a questionnaire with medical, social and demographic information        -  Blood draw for laboratory tests        -  Complete eye examination, including measurement of eye pressure and dilation of the          pupils to examine the back of the eye. Fluorescein angiography may be done. This test          involves injecting a dye into a vein in the arm. The dye travels to the blood vessels in          the eyes. A camera flashes a blue light into the eye and takes pictures of the retina          that show whether the dye has leaked from the blood vessels into the retina. Other          photographs of the eye may also be taken using a special camera.      Participants are followed in conjunction with their local eye doctor as required by the     status of their disease. Patients whose disease is stable are seen for an initial examination     and followed every 12 months for 3 years.   "
193616|NCT00379288|"     The purpose of this study is to evaluate the long-term safety of mometasone     furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F     MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID     and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on     inhaled glucocorticosteroids (ICS); evaluator-blind.      In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of     MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI     500/50 mcg BID will be evaluated.   "
193617|NCT00379301|"     This study involves treatment for atrial fibrillation (AF)—the most common heart condition in     the US—where the upper chambers of the heart beat very fast and in a disorganized manner.     This can be felt as palpitations, tiredness, shortness of breath and passing out, plus can     lead to stroke, damage to the heart muscle and a shorter life span. Study participants will     receive a common treatment for atrial fibrillation called radiofrequency ablation (RFA),     where small lesions or burns are made inside the heart to cut off the abnormal impulses     that cause AF. The purpose of this study is to compare the effectiveness of three different     common ablation strategies in patients with persistent or permanent AF. Subjects will be     randomized (like drawing straws) to be treated with one of the three strategies to see if     there is a difference in how well atrial fibrillation is controlled after treatment.   "
193618|NCT00379314|"     The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for     treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy     and safety but is still associated with the risk of intra- and post-operative complications.     A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which     utilises the obturator foramen for passage of the tape, is thought to lower the risk of     complications. The trial compares the TVT procedure with the TVT-O procedure in a randomized     fashion in order to detect differences in the rate of complications and in cure rate.   "
193619|NCT00379327|"     The purpose of this study of 100 pregnant women is to determine if acupuncture using real     needles that puncture the skin, starting at thirty seven weeks three days estimated     gestational age (EGA), will increase the percentage of women delivering on or before the     estimated date of confinement (EDC = 40 weeks EGA), compared with women treated identically     but with placebo needles that do not puncture the skin.   "
193620|NCT00379340|"     This phase III trial is studying how well combination chemotherapy with or without radiation     therapy works in treating young patients with newly diagnosed stage III or stage IV Favorable     Histology Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Radiation     therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination     chemotherapy) with or without radiation therapy may kill more tumor cells.   "
193621|NCT00379353|"     The goal of this clinical research study is to learn if thalidomide can improve symptoms such     as pain, fatigue,anxiety, poor appetite, depression, and sleep problems in patients with     advanced cancer.   "
193674|NCT00380042|"     The purpose of this study is to assess the safety and effectiveness of cortical stimulation     to the cerebral cortex of subjects who have suffered from treatment-resistant depression and     have failed routine attempts at controlling their depression.   "
193622|NCT00379366|"     Although ionizing radiations have been proposed for the prevention of intimal hyperplasia in     coronary and peripheral arteries, information is lacking on how irradiation may prevent     neointimal smooth-muscle cell proliferation and restenosis on prosthetic haemodialysis     vascular access. We will assess the preventive effect of one dose of radiations (14 Gy)     administered transcutaneously one day after dilatation of stenosis on prosthetic     haemodialysis vascular access in a randomized controlled trial with a standardized clinical     and ultrasonographic one-year follow-up.   "
193623|NCT00379379|"     The aim of this study is to find out whether the hypoglycemic and improving insulin     resistance effect will appear or not, when EA applying on specific acupoints of NIDDM     patients.   "
193624|NCT00379392|"     The primary aim of the proposed study is to collect data in an effort to estimate the     clinical effectiveness of implementing repetitive task practice (RTP) in addition to mental     imagery training (MIT) to improve upper extremity motor function and the quality of life of     chronic stroke patients.   "
193625|NCT00379405|"     Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance     therapy, compared to standard HAART therapies.   "
193626|NCT00379418|"     AIR STUDY      TITLE: Anti-Ischemic effects of Abciximab(Reopro)      PATIENT POPULATION: Patients undergoing PCI(an interventional procedure placing a small     stent/metallic tube to keep a narrowed artery in your heart open) and either on a stable     statin dose or not on a statin. Statin= cholesterol lowering drug(ie, lipitor, zocor).      INTERVENTION: Heparin vs. heparin + abciximab during PCI      PURPOSE: Measure the effects of abciximab on special healing blood stem cells     (EPC's-Endothelial Progenitor Cells), on inflammation, on oxidative stress and on     microvascular blood flow.      PATIENT ASSESSMENT:        1. 50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28.        2. Measurement of blood flow in selected suitable patients        3. 10 minute questionnaire before discharge and on visit on day 28.   "
193627|NCT00379431|"     Rituximab 1000 mg i.v. will be given on day 1 and 15, week 26 - 28, together with a     corticosteroid regimen consisting of methylprednisolone 100 mg i.v. 30 minutes prior to both     infusions.   "
193628|NCT00379444|"     This study will develop a culturally appropriate tobacco cessation behavioral intervention     for Alaska Native women who are pregnant and who use tobacco. We will examine the feasibility     of the intervention in terms of recruitment and retention of participants, acceptability to     patients and prenatal health care providers, and the potential effectiveness of the tobacco     use intervention.   "
193629|NCT00379457|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. It is not yet known which     combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.      PURPOSE: This randomized phase III trial is studying different combination chemotherapy     regimens to compare how well they work in treating young patients with nonmetastatic     rhabdomyosarcoma.   "
193630|NCT00379470|"     The study is a randomized, controlled trial, designed to test the efficacy and safety of a     new medical device, the NovoTTF-100A. The device is an experimental, portable, battery     operated device for chronic treatment of patients with recurrent or progressive glioblastoma     multiforme (GBM) using alternating electric fields (termed TTFields).   "
193631|NCT00379483|"     A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was     conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years     with transfusion-dependent iron overload.      The objective of this extension study is to assess the long-term safety of deferasirox and to     provide treatment in patients with transfusional iron overload.   "
193632|NCT00379496|"     The aim of this study was to evaluate the effect of acupuncture as a treatment for this     condition. Fifty-eight women diagnosed with fibromyalgia were randomly allocated to two     groups. One group received acupuncture (n=34) twice a week for 20 sessions in addition to     tricyclic antidepressants and exercises. The control group (n=24) received only tricyclic     antidepressants and exercises. A blinded assessor evaluated patients’ pain using visual     analog scale (VAS), tender points number (TePsN) and myalgic index (MI). The same assessor     also evaluated quality of life (QoL) using SF-36. These evaluations were done prior to     treatments, at the end of the 20 sessions, and again at six months, one year and two years     after the first evaluation. At the end of the 20 sessions, patients who had received     acupuncture were significantly better than those who had not in all measures of pain (VAS,     TePsN, MI) and in five subscales of SF-36. After six months, the acupuncture group was     significantly better than the control group in some measures of pain (TePsN and MI) and in     three subscales of SF-36. After one year, the acupuncture group showed significant advantage     in only one subscale of SF-36; at two years there were no significant differences between the     two groups on all outcome measures. The addition of acupuncture to usual treatment for     fibromyalgia is beneficial for pain and quality of life, but only in first six months.   "
193633|NCT00379509|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     lapatinib together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when     given together with radiation therapy in treating patients with locally recurrent or     chemotherapy-refractory locally advanced or metastatic breast cancer.   "
193634|NCT00379522|"     The purpose of the present trial is therefore to assess effects of arginine vasopressin vs.     saline placebo on hospital admission rate (primary end point), as well as hemodynamic     variables, fluid resuscitation requirements and hospital discharge rate (secondary study end     points) in presumed traumatic hemorrhagic shock patients with a systolic arterial blood     pressure <90 mm Hg after 10 min of standard shock treatment. Accordingly, the study reflects     an add-on design to standard traumatic shock therapy.      The hypothesis is that both arginine vasopressin and saline placebo have comparable effects     on hemodynamic variables, fluid resuscitation requirements, and hospital admission and     discharge rate. The alternative hypothesis is that arginine vasopressin has more beneficial     effects on hemodynamic variables, fluid resuscitation requirements, and hospital admission     and discharge rate than saline placebo.   "
193635|NCT00379535|"     The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy on     neuro-cognitive development of children followed up until two years.   "
193636|NCT00379548|"     We hypothesize that Asian Americans compared to Caucasians, will be at higher risk of     developing a pro-inflammatory state that may contribute to the development of heart disease     and diabetes when they change from a traditional Asian diet to a typical Western diet. These     inflammatory responses will be reflected by the activation of monocytes as measured by     protein kinase C (PKC), a known activator of monocytes.      We also hypothesize that the changes of these inflammatory responses in the gingival     crevicular fluid (GCF) will reflect similar changes of these markers in the plasma and     monocytes.      Specific aims:        1. To compare the inflammatory responses (primarily PKC activation in monocytes), between          Far-East Asian Americans and Caucasian Americans, when they change from a traditional          Asian diet to a typical American diet.        2. To correlate the biochemical changes of inflammatory responses in the plasma and          monocytes with those in the gingival crevicular fluid (GCF).   "
193637|NCT00379561|"     This Phase 1 trial will evaluate the safety and tolerability of PSA-Activated PSA-PAH1 in     subjects who have shown biochemical failure and have either completed at least one primary     radiation therapy for prostate cancer and have evidence of recurrent local prostate cancer     without metastases.   "
193638|NCT00379574|"     Diffuse large B-cell lymphoma is a most prevalent non-Hodgkin's lymphoma. Recently the     clinical results have been improved with new drugs and new modalities such as     cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every 2 weeks. Bortezomib     is well known to be effective for multiple myeloma and has been being tried for other     malignancies including lymphoma. The investigators will incorporate Bortezomib to CHOP every     2 weeks to further improve the clinical efficacy in diffuse large B-cell lymphoma.   "
193639|NCT00379587|"     The purpose of this trial is to determine if administration of rituximab after allogeneic     stem cell transplantation can reduce the incidence of chronic GVHD. Chronic GVHD is a medical     condition that can occur after bone marrow or stem cells are transplanted form one individual     to another. After the transplant, the donor immune system may recognize the recipient body as     foreign and may attempt to reject the body. Rituximab is a drug that interferes with the     immune system function by specifically targeting B cells and killing them.   "
193640|NCT00379600|"     To assess whether the anti-inflammatory effects of rosiglitazone result in improvements in     Rheumatoid Arthritis symptoms in patients for whom their existing Disease Modifying     Anti-Rheumatic Drug (DMARD) treatment does not give adequate relief.   "
193641|NCT00379613|"     The purpose of this study is to determine the optimal dose of sugammadex when this compound     is administered during deep neuromuscular block. Sugammadex is administered shortly (5     minutes) after administration of a high dose (1.2 mg/kg) of the neuromuscular blocking agent     rocuronium . Under these circumstance the neuromuscular block is deep. The safety and     pharmacokinetics of sugammadex are also studied.   "
193642|NCT00379626|"     The aim of this study is to determine if Cognitive treatment and hormone treatment can change     the relapse rate of sexual offenders.   "
193643|NCT00379639|"     This was a phase I dose escalation trial designed to determine the maximum tolerated dose     (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was     originally planned as a Phase I/II; however only Phase I of the study was conducted.   "
193644|NCT00379652|"     Hypertension and diabetes are among the most common chronic diseases in the United States.     Racial and ethnic minority groups are more at risk for these diseases than the Caucasian     population. This study will attempt to identify factors that contribute to racial and ethnic     differences in hypertension and diabetes care among minority patients of community health     centers (CHCs). This information will be used to design and implement programs to improve     quality of care in these communities.   "
193645|NCT00379665|"     This study is being conducted in order to determine if intratumoral chemotherapy will be     helpful in the palliation of endobronchial tumors when used in conjunction with endobronchial     brachytherapy.   "
193646|NCT00379678|"     THe study seeks to determine if pimecrolimus has a positive effect on increasing     antimicrobial peptide expression and reducing vaccinia virus growth in the skin explants from     patients with atopic dermatitis.   "
193647|NCT00379691|"     The purpose of this study is to determine the minimum effective bolus dose of phenylephrine     to prevent post-spinal hypotension in Cesarean section in 95 % of our patients. An adequate     response will be defined as the absence of hypotension or nausea/vomiting during the period     from induction of spinal anesthesia to uterine incision prior to fetal delivery.   "
193648|NCT00379704|"     Tissue factor is the main activator of coagulation cascades. Excessive tissue factor     expression is made responsible of thrombosis in a number of clinical situations including     thrombosis in contact with atherosclerotic plaques. Recent work showed that tissue factor     gene expression in adipose tissue was significantly increased in obese versus lean mice.      The main objective of this study is to show that tissue factor expression is increased in     human adipose tissue obtained from obese subjects and to identify its main tissular origin by     comparing abdominal and subcutaneous adipose tissue.      The secondary objectives are to identify the cell origin of tissue factor (adipocytes versus     stromal cells) and to analyze the relation ship between blood tissue factor and (i) tissue     factor expressed by adipose tissue, (ii) the amount of subcutaneous and profound adipose     tissue, and (iii) coagulation activation markers.   "
193649|NCT00379717|"     This non-randomized Phase I/II study is designed to determine the maximum tolerated dose     (MTD) of thoracic radiotherapy and concurrent chemotherapy with cisplatin and docetaxel in     patients with LA-NSCLC. All patients will receive weekly administrations of docetaxel 20     mg/m² and cisplatin 20 mg/m2 concurrently with radiotherapy. Radiotherapy will be delivered     using helical tomotherapy in 30 daily fractions over six weeks. Patients should have     recovered fully from induction concurrent chemoradiotherapy before they continue with the     consolidation chemotherapy phase. Patients will be entered in cohorts of at least 5 subjects.      The first cohort of patients will receive 30 fractions of 2Gy in six weeks up to a total dose     of 60Gy. The concurrent chemotherapy starts at day 1 of the radiotherapy and will be     administered 2-4 hours before the radiotherapy.      The radiotherapy fraction size will be escalated to 2.36Gy in three steps.   "
193650|NCT00379730|"     Prednisolone will be used as a model medication to identify new clinical outcomes for future     evaluation of new therapies in short-term studies (up to 4 weeks) in patients with Chronic     Obstructive Pulmonary Disease (COPD).   "
193651|NCT00379743|"     The Centers for Medicare and Medicaid Services (CMS) has awarded cooperative agreements to 6     sites from across the country (Salt Lake City, UT, Molokai, HI, Houston, TX, Newark, NJ,     Detroit, MI, and Baltimore City) to participate in a national 4-year demonstration (September     15, 2006 to September 30, 2010). One goal of the demonstration is to reduce disparities in     cancer screening among seniors from U.S. racial and ethnic minority populations. Each site     will focus on a specific racial/ethnic minority group, and collaborate with CMS in project     implementation. A Core questionnaire, the Cancer Screening Assessment (CSA) will be     administered at baseline to all participants in the demonstration. Participant     identification, randomization, and intervention implementation will be standardized across     sites.      Goal: The proposal developed by the Johns Hopkins Bloomberg School of Public Health in     collaboration with the Baltimore City Community Health Coalition is designed to address     persistent disparities in screening for breast, cervix, colon/rectum and prostate cancer     among Baltimore City's seniors.      Primary Objective: Conduct a randomized controlled trial (target N = 2,874) within a project,     to compare the efficacy of 2 interventions that differ in intensity to improve continuity and     outcomes of care among African Americans seniors.      Among African American seniors, compared to a less intensive intervention (general     information and educational materials), does the addition of facilitation services delivered     by a health coordinator result in a greater improvement in adherence to cancer screening     recommendations among those who are not known to have cancer?      Study Population: We will recruit African American residents of Baltimore, age 65 years or     older, and currently enrolled in Medicare Parts A and B. (Baltimore City's 82,202 seniors     represent 13% of its population, and account for 68% of the City's cancer deaths. Among these     seniors, 96% have Medicare Parts A and B, 54.5% have income levels at less than 250% of the     federal poverty guideline, and 55.6% are African American.)      Eligible participants will respond to a baseline questionnaire, Cancer Screening Assessment     (CSA). They will then be randomized to receive a less intensive or more intensive     intervention. The less intensive group will receive general information about cancer and     Medicare covered services, and instructions to discuss the information with their primary     care doctor. The more intensive group will receive the same information as the less intensive     group receives, plus tailored facilitation services delivered by a nurse-supervised community     health worker. The primary outcome variable will be the difference between randomized groups     in adherence to screening for breast, cervix, colon/rectum and prostate cancer.      A community advisory committee will guide all aspects of the study and will include important     stake holders (both public and private sectors), representatives from the Baltimore City     Community Health Coalition, the Baltimore City Department of Health, the Maryland Department     of Health and Mental Hygiene, community leaders, consumers, health care providers     (physicians, oncologists, nurse practitioners, physician assistants, nurses, social workers,     pathologists) and academicians.   "
193652|NCT00379756|"     This is a study consisting of four periods (screening, run-in, treatment, follow-up). A     four-week treatment-free, run-in period where the subject will make at least four attempts at     intercourse on four separate days with at least 50% of the attempts must be unsuccessful.     During run-in the subjects will be using a stopwatch to measure the time from erection     perceived hard enough for penetration until withdrawal from the partner's vagina. Next there     are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to     visit the clinic on 5 occasions over a period of 4 months.   "
193653|NCT00379769|"     This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week     run-in period will be followed by a median of 6 years of treatment with study medication in     addition to continuation of background glucose lowering therapy. Patients inadequately     controlled on background metformin will be randomised to receive, in addition to metformin,     either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio     of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in     addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of     patients receiving background metformin and SU at entry will be entered into the study.   "
193654|NCT00379782|"     This Cancer Prevention and Treatment Demonstration Project funded by the Centers of Medicare     and Medicaid Services awarded six sites across the United States to develop Patient Navigator     Programs to eliminate disparities in the rate of preventative cancer screening and timely     diagnosis and treatment of cancer for racial and ethnic minorities. This site of Molokai     General Hospital are focused on Pacific Islanders and Asian Americans. This program called     Kukui Ahi propose to increase screening and early detection for four targeted cancers-breast,     cervical, colorectal, and prostate- with lung cancer additionally being included in treatment     protocols to improve outcomes and satisfaction by employing a culturally appropriate     navigation protocol to facilitate utilization of healthcare services and decrease health     barriers.      The specific aims of the project is to:        1. Determine if a Navigator Program can reduce the proportion of the targeted cancers          diagnosed at a late stage,        2. Determine if the Navigator Program can improve the continuity of health care for cancer          patients,        3. Determine if the Navigator Program can improve quality of life and subjective well being          of navigated cancer patients,        4. Determine if the Navigator Program is a cost-effective way to reduce cancer care          disparities for screenable cancers.   "
193655|NCT00379795|"     This was an open-label, multicenter, extension study of intravitreally administered     ranibizumab in two cohorts. The first cohort (reported here) enrolled patients with primary     or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration     (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g     (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort enrolled     patients with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the     6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored     study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). The results of the second cohort     are reported separately (NCT01442064). The first cohort of this study enrolled two subsets of     patients: ranibizumab experienced and ranibizumab-naive. Patients were enrolled within 14     days of completion of the 24 month treatment phase of the previous study.   "
193656|NCT00379808|"     The purpose of this study is to determine whether a particular substance involved in     inflammation, called leukotrienes, is involved in causing heart disease to occur or to     progress.   "
193657|NCT00379821|"     Malaria is a sickness caused by a germ that can get into a person's body when a mosquito     bites them. It can cause fever, headache, body aches and weakness. It can even cause death,     especially in children. When malaria is treated with the appropriate medicine(s), it can be     cured completely. The purpose of this study is to find out if it is better to use chloroquine     alone or in combination with another drug to most effectively treat malaria. About 640     children with malaria, aged 6 months to 5 years of age, from the Blantyre Malaria Project     Research Clinic at the Ndirande Health Center in Malawi will be in the study. They will be     treated with either chloroquine alone or a combination of chloroquine plus another medication     (azithromycin or artesunate or atovaquone-proguanil) every time they get malaria for a year.     Blood samples will be collected and tested at least every 4 weeks. Participants will be     involved in the study for 1 year.   "
193658|NCT00379834|"     To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with     Cosopt   "
193659|NCT00379847|"     This study will investigate the application of a vasopressin antagonist in the treatment of     hyponatremia most likely caused by inappropriate AVP secretion. The population studied will     include patients with euvolemic or hypervolemic hyponatremia.   "
193660|NCT00379860|"     To evaluate the safety and tolerability of multiple doses of LXR in healthy adults.   "
193661|NCT00379873|"     This research is designed to study the effects of chiropractic adjustment on the     physiological responses (EEG, EMG, HRV, skin temperature, and respiration) of college student     and faculty population.   "
193675|NCT00380055|"     The purpose of this demonstration is to evaluate the effectiveness of using community     outreach workers (navigators) to help American Indians living in rural areas overcome     barriers to appropriate cancer screening, diagnosis, and treatment.   "
193676|NCT00380068|"     The primary objective of this study was to evaluate the safety and efficacy of ambrisentan in     a broad population of participants with pulmonary hypertension (PH). Secondary objectives of     this study were to evaluate the effects of ambrisentan on other clinical measures of     pulmonary arterial hypertension (PAH), long-term treatment success, and survival.   "
193677|NCT00380081|"     The purpose of this study is to evaluate sleep onset following administration of Transcept     zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.   "
193678|NCT00380094|"     Study of diagnostic tests for heart attack for patients with chest pain.   "
193679|NCT00380107|"     It is the purpose of the researchers to identify the variation in intravascular deficits     which can have relevance in high risk patients for minor and medium sized surgery.      The investigators will also estimate fluid deficit in healthy, non-fasting subjects for     comparison.   "
193711|NCT00380536|"     This study will evaluate the effectiveness of a medical illness self-management program in     improving the health and health behavior of people who are receiving care at a community     mental health center.   "
193662|NCT00379886|"     Electroconvulsive therapy is the most effective treatment in severe depression and the effect     is related to the generalized seizure induced by the treatment. General anesthesia is used     during the treatment. Since only a brief period of unconsciousness is required anesthetics     with a rapid recovery profile are used.      Methohexital, a barbiturat, is internationally considered the golden standard, bot other     short-acting anesthetics are used. In Denmark the most frequent used anestheticum for ECT is     Thiopental, a barbiturat, but also Propofol, a non-barbiturat, is used in many psychiatric     departments.      Several studies have shown that Propofol reduce seizure duration in comparison with     barbiturates. So far, no studies have demonstrated any clinical implications of the reduced     seiziure duration. However, these studies have included rather few patiens, most have been     retrospective, and in the only prospective study conducted, uni-lateral ECT was used.      The aim of this study is to compare the clinical effect of ECT in patients anesthesized with     either Propofol or Thiopental. The hypothesis is that the shorter duration of seizures found     with Propofol as anestheticum will increase the number of treatments needed to clinial     respons. Furthermore we want to study differences in EEG-relate parameters previously shown     to have prognostic value. Hospitalized patients with major depression, who is to be treated     with ECT, are randomized to anesthizia with either Thiopental or Propofol. They are rated     with Hamilton depression scale and BDI before treatment, after six treatments and when     treatment is concluded. When treatment is ended the patients are furthermore rated with MMSE     to evaluate their degree of cognitive impairment.   "
193663|NCT00379899|"     The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates     the progression of vascular calcification over one year, compared with a treatment regimen     that includes flexible vitamin D dosing in the absence of cinacalcet, in subjects with     chronic kidney disease receiving hemodialysis   "
193664|NCT00379912|"     This trial is designed to explore a modified dose and schedule of azacitidine in order to     more effectively address the needs of patients with low-risk myelodysplastic syndromes (MDS),     i.e., to alter the natural history of the disease without excessive toxicity or burden. The     administration of erythropoietin is designed to influence the differentiation of primitive     hematopoietic cells in which azacitidine has reversed the abnormal phenotype to red blood     cells for patients in whom inadequate production of red blood cells is the major clinical     issue.   "
193665|NCT00379925|"     Obese African Americans are at risk for diseases such as diabetes, cancer, and heart disease.     Church-based interventions have the potential to positively influence the health habits and     behaviors of a large percentage of African Americans. The purpose of this study is to     evaluate the effectiveness of a church-based program that emphasizes increased physical     activity and healthy dietary habits among members of predominately African American churches     in South Carolina.   "
193666|NCT00379938|"     This study investigates the safety and effectiveness of a preventative vaccine for parvovirus     B-19 infection. Eighty-nine healthy adults ages 18-49, whose blood tests negative for B-19,     will be enrolled. Participants will be randomly chosen to receive 1 of 4 possible vaccine     types: low dose of the vaccine and an adjuvant (substance which assists with transfer of     medication to body); high dose of the vaccine alone; high dose of the vaccine and an     adjuvant; or saline (substance containing no medication). Participants will receive 3     vaccinations over a 6 month period and will be followed for 6 additional months. Blood     samples will be taken at months 1, 2, 6, 7 and 12 to determine if antibody, protein produced     by the body's immune system that recognizes and helps fight infections, has been formed to     the vaccine. These tests measure vaccine efficacy, i.e., determine if the vaccine induces     immunity. All participants will be followed closely for safety throughout the study.   "
193667|NCT00379951|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem     sodium as initial therapy for the treatment of complicated urinary tract infections,     including pyelonephritis in indian adults.   "
193668|NCT00379964|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem     sodium as initial therapy for the treatment of complicated urinary tract infections,     including pyelonephritis in indian adults.   "
193669|NCT00379977|"     This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus     acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4     and 5 months of age.   "
193670|NCT00379990|"     This is an exploratory study to examine the effect of iNOS inhibition in rheumatoid arthritis     patients. The study involves 28 days repeat dosing with GW274150 (dose determined by the     results from a previous study), prednisolone (7.5mg) or placebo.   "
193671|NCT00380003|"     The purpose of this study is to determine whether a compound known as EVT 201 is effective in     treating people diagnosed with primary insomnia ( difficulty sleeping with no other     significant contributing factor, such as depression).   "
193672|NCT00380016|"     This study offers catheter-based treatment of heart or artery disease. This protocol permits     treatment of patients with cardiovascular diseases who may not be eligible to participate in     current research protocols. The treatment offered in this protocol is not experimental, but     rather standard treatment provided in most large referral hospitals in the United States.      Patients 18 years of age and older who are candidates for catheter-based treatment of     obstructive artery disease, including blocked blood flow in a coronary artery (artery to the     heart) or in an artery of the arm, leg, brain or kidney may be eligible for this study.     Candidates are screened with a general medical evaluation that may include blood tests,     magnetic resonance imaging, and monitoring of heart rate and rhythm.      Participants undergo angioplasty or stenting for blockage in an artery to the heart or an     artery of the arm, leg, brain or kidney. The procedure uses a balloon-tipped catheter to open     the blocked artery and likely requires permanent implantation of a metal tube (stent) to     improve blood flow through the vessel. During the procedure, the patient is given a sedative     and pain medication, if needed.   "
193673|NCT00380029|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed. Giving erlotinib after surgery may kill     any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well erlotinib works when given before and after     surgery in treating patients with muscle-invasive bladder cancer.   "
193680|NCT00380120|"     Prospective controlled randomized clinical trial. Consecutive patients with acute proximal     deep vein thrombosis (DVT) of the lower extremities, with or without contemporary     manifestations of pulmonary embolism, are randomized to receive either a fixed duration of     anticoagulant therapy (three months in patients with DVT secondary to transitory risk     factors, six months in patients with idiopathic DVT) or a flexible duration of anticoagulant     therapy, according to the persistence of residual thrombi, as shown by leg veins     ultrasonography (up to 1 year in patients with secondary DVT, up to 2 years in those with     idiopathic DVT). All patients are followed up to three years to assess the development of     (objectively documented) recurrent thromboembolism. The rate of recurrent thromboembolism is     compared between the two study groups, as well as the rate of major bleeding complications     occurring during anticoagulation.   "
193681|NCT00380133|"     This study will assess the effects of single oral doses of SB681323 and prednisolone on     biomarkers in induced sputum and blood COPD patients   "
193682|NCT00380146|"     The main purpose of this study is to compare the drug levels of sulfadoxine-pyrimethamine     found when given to pregnant women for the prevention of malaria to those found in pregnant     women given the same drug with artesunate for the treatment of malaria, and also with those     drug levels found in non-pregnant women in other malaria treatment studies.   "
193683|NCT00380159|"     To assess the safety of 48 weeks of treatment with 10 mg of elvucitabine in combination with     background ART in subjects who completed protocol ACH443-014A and meet the inclusion and     exclusion criteria.   "
193684|NCT00380172|"     The purpose of these studies are to evaluate the effect on vision in subjects with AMD who     received active and placebo treatment in the MIRA-1 study.   "
193685|NCT00380185|"     Atherosclerosis, a condition in which fatty deposits build up along the inner walls of     arteries, can occur throughout the body. The purpose of this study is to examine the possible     genetic differences that may influence where atherosclerosis occurs.   "
193686|NCT00380198|"     The purpose of this clinical research study is to compare Apadenoson and adenosine to     treadmill exercise stress SPECT MPI   "
193687|NCT00380211|"     The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of     FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be     compared to a standard immune response criteria, for both young and elderly populations.   "
193688|NCT00380224|"     This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine),     with respect to the affect on weight during the treatment of outpatients with schizophrenia.     The study will compare the effect of these medications on several variables, including body     weight and triglyceride levels.   "
193689|NCT00380237|"     Avian influenza (AI), also known as bird flu, has become a major public health concern in     many regions of the world. The purpose of this study is to evaluate the safety of and immune     response to an AI vaccine in healthy adults.   "
193690|NCT00380250|"     The primary purpose of this study is to evaluate the efficacy and safety of administration of     lubiprostone in patients with irritable bowel syndrome with constipation.   "
193691|NCT00380263|"     To investigate headache score and accompanying symptoms during and after infusion of PACAP38     i migraine patients   "
193692|NCT00380276|"     Open-label treatment with MPC-7869 for participants in a previous randomized study.   "
193693|NCT00380289|"     Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide     diuretics or beta blockers or combination of the two?   "
193694|NCT00380302|"     Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in     patients with Alzheimer's disease that is not too severe. There is also evaluation of whether     patients who take the study medication improve compared to patients who take a placebo (sugar     pill).      Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in     patients who join the study.   "
193695|NCT00380315|"     This study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy     as an anti-tussive agent in cough patients.   "
193696|NCT00380328|"     To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole     when co-administered.   "
193697|NCT00380341|"     The purpose of this study is to determine the effects of spinal manipulative therapy on     autonomic balance and to determine if there exists a relationship between autonomic state and     postural control.   "
193698|NCT00380354|"     This study will evaluate the efficacy and safety of GSK256066 in the treatment of subjects     with mild bronchial asthma, using a number of clinical and biological markers of efficacy.   "
193699|NCT00380367|"     The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent     Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India.     Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11,     16, and 18.   "
193700|NCT00380380|"     Please note this study is not being conducted in the United States. The purpose of this study     is to assess the acute effects of vildagliptin, an unapproved drug, in reducing post-meal     glucose levels by delaying gastric emptying.   "
193701|NCT00380393|"     This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent     children from falling ill with malaria and to evaluate vaccine safety.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
193702|NCT00380406|"     The purpose of this study is to determine whether gonadotropin releasing hormone agonists     (medical therapy) will protect against ovarian failure in reproductive aged women undergoing     sterilizing chemotherapy.   "
193703|NCT00380419|"     This study will evaluate the impact of interpersonal psychotherapy on the course of     depression during and after pregnancy, as well as its effect on infant birth outcomes.   "
193704|NCT00380445|"     Please note this study is not being conducted in the United States. The purpose of this study     is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and     muscle metabolism in patients with type 2 diabetes mellitus.   "
193705|NCT00380458|"     The purpose of this study is to assess whether tonsillectomy and UPPP performed using the     study device to treat Obstructive Sleep Apnea (OSA) symptoms in adults is associated with     less postoperative pain during the 21-day postoperative recovery period compared to     electrocautery dissection.   "
193712|NCT00380549|"     The primary purpose of the current study is to investigate if the CONSERVE® A-Class Total Hip     with BFH technology will lead to lower blood ion levels in patients, as compared to patients     in a recent study who received the CONSERVE® Plus Total Resurfacing Hip System, another     metal-on-metal device. We are also comparing functional and radiographic (x-rays) outcomes     between patients who receive the CONSERVE® A-Class Total Hip compared to those who have     received the CONSERVE® Plus Total Resurfacing Hip System.   "
193713|NCT00380562|"     The purpose of this study is to examine the effectiveness of the Experience Corps program in     preventing or delaying physical disability in older adults, by studying the effects of     volunteerism on physical, social and cognitive well-being.   "
193714|NCT00380575|"     This study will investigate the application of a vasopressin antagonist in the treatment of     hyponatremia most likely caused by inappropriate AVP secretion. The population studied will     include patients with euvolemic or hypervolemic hyponatremia.   "
193715|NCT00380588|"     To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine     alone by comparison in patients with advanced biliary tract cancer   "
193716|NCT00380601|"     An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA   "
193717|NCT00380614|"     Since a proportion of patients with Acute Viral Hepatitis-B develop severe hepatitis and     fulminant hepatic failure, it is logical to believe that a rapid reduction in the HBV DNA     levels by using antiviral agents could result in a less intense host response against the     hepatitis B virus. However, the experience with lamivudine treatment of immunocompetent     patients with AVH-B is limited.The aim of the present study was to evaluate the efficacy,     utility and safety of lamivudine in treating immunocompetent patients with AVH-B.   "
193718|NCT00380627|"     Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.   "
193719|NCT00380640|"     The purpose of this study is to assess the efficacy of trimethoprim in promoting wound     healing and decreasing blister formation in patients with Epidermolysis Bullosa.   "
193720|NCT00380653|"     The goal of this study to find the highest tolerable dose of sapacitabine that can be given     to patients with advanced leukemias or myelodysplastic syndromes.   "
193721|NCT00380666|"     The trial evaluates the utility of 18FDG-PET/CT scan in the target definition process when     SBRT is planned for stage I NSCLC.   "
193722|NCT00380679|"     According to the Advisory Committee on Immunization Practices (ACIP), all people aged 50     years or older and persons aged less than 50 years who have medical conditions that put them     at increased risk for serious influenza disease should receive an annual influenza     vaccination. However, since the mid-1990s, vaccination rates and racial disparities have     mostly remained static, and there has been limited progress towards the Healthy People 2010     objectives for influenza vaccination coverage.      The purpose of this study is to determine what proportion of previously unvaccinated persons     in target groups for whom influenza and pneumococcal vaccine are recommended will accept and     receive influenza and/or pneumococcal vaccine in an urban emergency department (ED), and to     estimate the potential impact of ED vaccination on population-based vaccination coverage. The     intervention will utilize a combination of assessment survey, vaccine information and     pre-printed vaccine order sheets.      The target population for influenza vaccinations includes all patients aged 18 years and     older for whom influenza vaccine is recommended by the ACIP. This includes all persons aged     50 years and older and persons aged 18 to 49 years who are in one of the following groups: 1)     health care workers, 2) pregnant women, 3) residents of long-term care facilities, 4)     household contacts and out-of-home caregivers of children aged 0 to 23 months, or 5) persons     with underlying chronic medical conditions which increase their risk of influenza-related     complications. The target population for pneumococcal vaccination includes all patients aged     65 years or older who have not previously been vaccinated against pneumococcus or have not     received the vaccine within 5 years (and were less than 65 years at the time of vaccination).   "
193723|NCT00380692|"     The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD     (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD     (Autism Spectrum Disorder).   "
193724|NCT00380705|"     Allow physicians not familiar with anti-leukotriene based therapy to test it   "
193725|NCT00380718|"     The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is     tailored to individual patient tolerance in patients with advanced non-small cell lung cancer     (NSCLC).   "
193726|NCT00380731|"     This study will evaluate the effect of cognitive behavioral therapy on the brain during     emotional and behavioral responses to social stimuli in people with social phobia.   "
193727|NCT00380744|"     The purpose of this study is to examine the safety and efficacy of this antibody in     rheumatoid arthritis patients.      Part A of the study is an initial dose escalation phase      Part B of the study is a randomized allocation of the entire dosing group to parallel     treatment assignments   "
193728|NCT00380757|"     STUDY OBJECTIVES The overall goal of this study is to compare bystander fatigue and CPR     quality after 5 minutes of the new 30:2 versus the old 15:2 chest compression to ventilation     International Resuscitation Guidelines, in a population aged 55 or greater.      More specifically, we will compare each CPR ratio with regard to:        1. The achieved frequency and depth of chest compressions,        2. Participant rating of their perceived level of exertion, and        3. Resulting serum lactate levels in a subset of the participants.      STUDY HYPOTHESIS      In a population aged 55 or greater, the new 30:2 CPR ratio will lead to:        1. less frequent and shallower chest compressions over the 5-minute study period;        2. higher rating of perceived level of exertion; and        3. higher serum lactate levels in a subset of participants when compared to the old 15:2          CPR ratio.   "
193749|NCT00381030|"     The purpose of our study was to determine if a strategy of starting a heart medication     (Beta-blocker) before patients leave the hospital and then being seen by a nurse manager     would reduce subsequent hospitalizations compared to usual care.      Hypothesis: A nurse-directed heart failure management program with inpatient initiation of     beta blockers will improve health outcomes in a vulnerable, predominantly Hispanic and     African American population.   "
194491|NCT00385125|"     Phase II study for treatment of patients with relapsed or primary refractory aggressive B-     cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for     autologous stem cell transplantation.   "
193729|NCT00380770|"     Kaposi's sarcoma (KS)is the commonest malignancy associated with HIV/AIDS. Therapy for this     cancer, which causes substantial morbidity, is suboptimal in resource poor settings. The     reasons for this are: advanced state of immunosuppression when patients present for clinical     care, concomitant opportunistic infections, non- availability of antiretroviral therapy     (ART), non-availability and toxicity of chemotherapy (CXT), when available, in patients with     full blown AIDS, prohibitive costs of bone marrow support and fiscal constraints in resource     poor settings.      A recent Cochrane Review assessed the effectiveness of current therapeutic regimens for HIV     KS, with a focus on options available in resource poor settings. The major selection criteria     for this review were randomized controlled trials for HIV KS in adults. The main conclusions     were that data from randomized controlled trials on effective treatments for HIV KS are     sparse, particularly among people who are also taking highly active antiretroviral therapy     (HAART). Alitretinoin gel is effective for therapy of cutaneous lesions, pegylated liposomal     doxorubicin is effective for advanced KS and radiotherapy is effective for treating cutaneous     lesions. Apart from the randomized trial of radiotherapy, no trials applicable to developing     settings were identified. Therapy of HIV KS in developing countries thus remains unanswered.      The authors concluded that therapies discussed in the review are unlikely to be available or     affordable in developing countries where the bulk of HIV infection and KS occur, apart from     radiotherapy at a few tertiary centers. However, recent changes in pricing due to the global     alliance and access initiatives mean that HAART is likely to be more available and accessible     to developing countries in the near future. South Africa now has committed to this at cabinet     level and had a task force to address this issue.      HAART has been proposed as therapy for HIV KS on the basis of restoring immune competence and     minimizing the HIV tat drive to KS formation. It also improves immunologic control of HHV 8     possibly through interrupting the HIV-1- HHV-8 interaction.      There has been only one randomised trial conducted in Spain which compared HAART to the     combination of HAART and CXT. There is to date no prospective, randomised controlled trial     which compares the efficacy of HAART to the standard of care in HIV KS in Africa.   "
193730|NCT00380783|"     This study will explore the safety and effectiveness of different doses of AGN 203818 in     treating the pain associated with painful bladder syndrome/interstitial cystitis   "
193731|NCT00380796|"     The purpose of this long-term observational study is designed to collect additional     information on incidence of cancer and cause of death among patients who have participated in     clinical trials of infliximab in the treatment of COPD. Patients must have received at least     1 dose of study agent (ie, placebo or infliximab) in the primary studies to be eligible for     participation in this long-term follow-up study. Information on deaths and cancers will be     collected twice yearly for a period of 5 years from each patient's last safety visit in the     primary study.   "
193732|NCT00380809|"     The primary purpose of this study is to evaluate the long term effects of the polymer-based     slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior     rotablation, in an angiographically well defined group of patients with complex calcified     coronary lesions.   "
193733|NCT00380822|"     To investigate the efficacy and safety of miglitol in Japanese patients with type 2 diabetes     that is insufficiently controlled diet alone.   "
193734|NCT00380835|"     The purpose of the study is to evaluate the incidence of cardiac toxicity of amrubicin when     administered to patients with metastatic breast cancer.   "
193735|NCT00380848|"     The purpose of this study is to determine whether hemodiafiltration, a new form of     hemodialysis can improve sleep apnea in patients with end stage kidney disease.   "
193736|NCT00380861|"     This study will evaluate whether design features of one implant design allows more knee bend     than the other. Patients will have 1 design in the left knee and 1 design in their right     knee. Both knee surgeries will be on the same day.   "
193737|NCT00380874|"     Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral     neuropathy.   "
193738|NCT00380887|"     The purpose of this study is to determine bioequivalence and bioavailability of four     different Premarin/MPA test formulations versus the current formulation for Prempro.   "
193739|NCT00380900|"     The purpose of this study is to evaluate the safety and tolerbility of ascending multiple     oral doses of AGG-523 in healthy subjects and in subjects with osteoarthritis.   "
193740|NCT00380913|"     This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain     in subjects experiencing pain due to diabetic peripheral neuropathy.   "
193741|NCT00380926|"     Native populations consuming high amounts of fish suffer less from allergic diseases. The     purpose of this study is to determine whether polyunsaturated fatty acids (fish oil) might     have a disease modifying influence on asthmatics sensitized to house dust mite.   "
193742|NCT00380939|"     This study was designed to assess the effects on coronary artery plaque using aggressive     lipid-lowering therapy versus moderate lipid-lowering therapy. A substudy will examine the     effect of these treatments on brachial artery vasoactivity.   "
193743|NCT00380952|"     This protocol was designed for testing the intraoperative use of the Dune device. This     multicenter study will take place in Israel at 12 sites.   "
193744|NCT00380965|"     This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain     in subjects experiencing pain due to chemotherapy-induced neuropathic pain in patients with     cancer.   "
193745|NCT00380978|"     The purpose of this study in nulliparous women undergoing induction of labor is to determine     whether initiation of neuraxial analgesia compared to systemic opioid analgesia early in     labor (< 4 cm cervical dilation)affects the cesarean delivery rate.   "
193746|NCT00380991|"     The purpose of this study is to demonstrate the absence of potential irritation (primary     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the     product Dermacyd Delicata (new fragrance of Dermacyd)   "
193747|NCT00381004|"     The goal of this clinical research study is to learn if using a combination of fludarabine,     cyclophosphamide, and rituximab, with sargramostim (GM-CSF) can help to control previously     untreated chronic lymphocytic leukemia (CLL). The safety of this combination will also be     studied. This study will evaluate antibody-dependent cellular cytotoxicity (ADCC) and its     relationship to response.   "
193748|NCT00381017|"     This is a Phase 3b, randomized, open-label, parallel-group, multi-center, multi-national     study of low-dose maintenance Peg interferon alpha-2b (Peg-Intron®) in subjects with human     immunodeficiency virus-hepatitis C virus (HIV-HCV) co-infection. The primary objective is to     compare at end of study the efficacy of Peg-Intron® monotherapy (0.5 µg/kg subcutaneously     once weekly for 24-36 months) versus standard supportive care, using the time to any of the     following clinical events (death, decompensation, liver transplant, hepatocellular carcinoma     [HCC]) as endpoints.   "
193750|NCT00381043|"     This is a study of a medication, acamprosate, which is an FDA approved medication for alcohol     problems. We will be examining whether acamprosate compared to a sugar pill (placebo) is more     effective for helping with drinking in a Family Medicine clinic.   "
193752|NCT00381069|"     The purpose of this study is to design, implement, and evaluate a recreation site-based     obesity prevention & control intervention for 7-9 year old children and their families by     targeting physical activity and dietary behaviors.   "
193753|NCT00381082|"     Objective      To compare the cure rates (defined as the complete absence of live lice, adults or nymphs, as     diagnosed by wet-combing of three Australian approved head lice products for the treatment of     primary school children with head lice infestation. The study design will be randomised and     assessor-blind using three comparative parallel treatment groups.      The study population will consist of Queensland state primary school children (up to Year 7)     with live head lice (adults or nymphs) on the hair or scalp who have not used any head lice     product in the four weeks prior to the study.   "
193754|NCT00381095|"     The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in     the adjunctive treatment of subjects with cancer-induced bone pain.   "
193755|NCT00381108|"     To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic     Hyperplasia.   "
193756|NCT00375427|"     The objective of this study is to assess the clinical benefit of two different dosing     schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who     have already been treated with zoledronic acid for about one year.   "
193757|NCT00375440|"     The purpose of this study is to determine if tranexamic acid significantly reduces blood loss     and blood transfusion in revision total hip replacement. Tranexamic acid is a drug that helps     to reduce blood loss during surgery. Revision total hip replacement surgery is treatment for     patients who have previously had hipe replacement surgery which failed and must be     repaired/replaced.   "
193758|NCT00375453|"     This study will evaluate the safety and tolerability of SH U04722 in patients with solid     tumor cancers. In addition, this study will identify the recommended dose and administration     schedule of SH U04722 for phase II development in Japanese cancer patients, evaluate the     pharmacokinetic profile of SH U04722 and gather preliminary data on the effectiveness of SH     U04722 in patients with solid tumors.   "
193759|NCT00375466|"     In this study we will investigate whether tranexamic acid given as an intravenous bolus     injection before start of surgery, followed by a continuous infusion during surgery reduces,     perioperative hemostatic activation, and postoperative bleeding and the need for transfusions     of blood components in elderly patients undergoing combined aortic valve replacement and     coronary artery bypass surgery. Tranexamic acid will be compared with placebo (0.9% sodium     chloride) in a randomized and double-blind study design.      The study hypothesis is that tranexamic acid will reduce hemostatic activation and     postoperative hemorrhage and the need for blood component transfusions in this group of     patients.   "
193760|NCT00375492|"     This trial is designed to compare the effects of twice-daily exenatide and twice-daily     placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2     diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus     a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their     current oral antidiabetes agent regimen and participate in a lifestyle modification program.   "
193761|NCT00375505|"     This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months     over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral     density in premenopausal women with hormone receptor negative breast cancer and adjuvant     chemotherapeutic treatment   "
193762|NCT00375518|"     This study will compare atorvastatin (Lipitor) with a placebo (inactive pill) to see if this     drug reduces heart rhythm abnormalities (arrhythmias) or lung inflammation after thoracic     surgery. Preliminary results suggest that cholesterol lowering drugs (statins) may reduce     problems after surgery such as arrhythmias or lung inflammation which may be serious. This     study will be randomized and double blind, meaning that patients are placed in groups purely     by chance, like flipping a coin. Neither the patient or doctor will know which group the     patient is in.   "
193763|NCT00375531|"     Objectives: The primary objective of this study is to conduct a randomized pilot study on the     efficacy of Mindfulness Meditation (MfM) on sleep in post war Iraqi/Afghanistan veterans with     PTSD. It is hypothesized that the change in sleep (measured by actigraphy), sleep self report     measures, and PTSD symptoms (measured by the PTSD Checklist) from baseline, 8 weeks and 12     weeks will be greater for veterans with PTSD who are treated with MfM, controlling for     pretreatment values and other clinical and demographic factors.      A secondary objective will investigate whether there is an improvement in psychological     wellness (measured by optimism, perceived wellness, and spirituality) following MfM     treatments.      It is hypothesized that change in optimism, perceived wellness, and spirituality from     baseline, 8 weeks and 12 weeks will improve in veterans with PTSD who are treated with MfM,     controlling for pretreatment values and other clinical and demographic factors. Physiological     measures of actigraphy in the home will be done at baseline, eight weeks, and twelve weeks.     Subjective measure of sleep include measurements of sleep and quality of life(FOSQ) and     subjective sleep quality (PSQI). Other self-report measures that will examine psychological     wellness include the Life Orientation Test (LOT), the Perceived Wellness Survey (PWS) and the     Spirituality Assessment Scale (SAS).   "
193764|NCT00375544|"     This Phase I study is being conducted to examine the efficacy of the Light Sciences LLC     (LSLLC) phototherapy device for home (self) treatment of knee osteoarthritis (OA).   "
193765|NCT00375557|"     The primary aim is to determine whether Divalproex ER or one of the atypical antipsychotics     is more effective improving dementia related behavioral symptoms in patients with dementia,     and evaluate the impact of such improvements on other clinical domains, such as quality of     life, functional status.   "
193766|NCT00375570|"     The Purpose of this study is to evaluate the safety of ME-609 for the treatment of recurrent     herpes labialis in adolescents.   "
193786|NCT00381303|"     The purpose of this study is to evaluate any differences in the effectiveness, safety, and     tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg     twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a     48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV)     agents will also be administered and will be chosen by the Investigator based on resistance     testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).   "
193767|NCT00375583|"     This study, conducted in Chennai, India, will determine whether a new treatment regimen of     albendazole and diethylcarbamazine for lymphatic filariasis can eliminate the disease more     quickly than the standard regimen. Lymphatic filariasis is caused by infection with very     small filarial worms, particulalry Wuchereria bancroti, that are spread by mosquitoes. The     infection can lead to swelling of the arms, legs, breast and scrotum and can progress to     permanent swelling of the legs or arms called elephantiasis. The study will see if a higher     and more frequent dose of albendazole is better at clearing filarial worms from the blood     than the current treatment.      Healthy people between 18 and 55 years of age who are in good health and who are infected     with Wuchereria bancrofti may be eligible for this 28-month study. Candidates must be willing     to spend 4 days in the Government General Hospital in Chennai, India, at the beginning of the     study. They are screened with a medical history, a brief physical examination, ultrasound     (picture generated by sound waves) of the groin or chest, and blood tests to check for     infection with Wuchereria bancrofti and to measure white blood cell counts.      Participants undergo the following procedures:      -4-day hospitalization      Random assignment to receive either standard treatment (400 mg albendazole and 300 mg DEC     given once a year for 2 years) or the experimental regimen (800 mg albendazole and 300 mg DEC     given twice a year for 2 years)      Urine pregnancy test for women of childbearing age      Receive first treatment dose      Monitoring for symptoms      -6-month outpatient visit      Short history, physical examination and blood test      Second treatment dose for subjects receiving 800 mg albendazole      Urine pregnancy test for women of childbearing age      -1-year outpatient visit      Short history, physical examination and blood test      Second or third treatment dose, depending on treatment group      Repeat ultrasound in subjects whose first ultrasound detected adult worm      Urine pregnancy test for women of childbearing age      -18-month outpatient visit      Short history, physical examination and blood test      Fourth treatment dose for subjects receiving 800 mg albendazole      Urine pregnancy test for women of childbearing age      -24-month outpatient visit      Short history, physical examination and blood test      Final dose of albendazole and DEC at standard doses      Repeat ultrasound in subjects whose first ultrasound detected adult worms      Urine pregnancy test for women of childbearing age   "
193768|NCT00375596|"     This study will evaluate the safety and efficacy of a new allergy medication   "
193769|NCT00375609|"     Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the     prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.   "
193770|NCT00375622|"     Hereditary hemorrhagic telangiectasia (HHT) is associated with recurrent epistaxis in 90% of     cases. Good response to hormone treatment has been documented, although its use remains     controversial. A double-blind placebo-controlled trial with estrogen treatment did not show     any benefit over placebo. The aim of this study is to examine the efficacy of an     antiestrogenic agent, TAMOXIFEN, in the treatment of HHT-associated epistaxis. The study will     include up to 60 patients, over 18 years old.   "
193771|NCT00375635|"     The aim of this study is to examine removal of protein bound uremic substances by mFPSA in     chronic hemodialysis patients. mFPSA is an extracorporal blood purification system developed     for detoxification in acute liver failure by removal of protein bound as well as water     soluble substances.   "
193772|NCT00381121|"     The purpose of the study is to create a Nephrology Tissue Biobank enabling the study of     kidney disease from the perspectives of epidemiology, genetics and molecular biology.   "
193773|NCT00381134|"     Kidney disease affects about one out of three people with diabetes mellitus, a common medical     problem. Treatment of kidney disease with medications that lower blood pressure can slow the     kidney disease but there is no known cure. This study is designed to test the hypothesis that     certain combination-based blood pressure lowering regimens (of FDA approved medications) are     better than single agent-based regimens for lowering blood pressure and further slowing or     preventing progression of this incurable disease   "
193774|NCT00381147|"     We looked for the effectiveness of low-dose long-term prescription of clarithromycin in     mustard-induced chronic pulmonary lesions, especially bronchiolitis obliterans   "
193775|NCT00381160|"     The primary aim of this study is to examine the effect of a multi-component intervention,     designed to reduce consumption of sugar-sweetened beverages, on weight gain, total energy     intake, and diet quality in adolescents. The secondary aim is to evaluate whether outcomes of     the intervention differ between adolescents for whom 100% fruit juice vs. other products     (i.e., soda, fruit punch, lemonade, iced tea, coffee drinks, energy drinks, sports drinks)     constitutes the primary source of sugar from beverages.   "
193776|NCT00381173|"     The purpose of this study is to evaluate the feasibility, safety, and tolerability of     administering ZYC300 with Cyclophosphamide (Cytoxan).   "
193777|NCT00381186|"     To evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based on     general public health recommendations, on glucose tolerance, insulin resistance and metabolic     cardiovascular risk factors in Dutch subjects with impaired glucose tolerance (IGT).   "
193778|NCT00381199|"     Most chronic pain patients with insomnia are currently not well-managed using existing     medications. If found to safely improve sleep with chronic pain patients, nabilone could be     added to the treatment options available in the management of fibromyalgia and associated     symptoms.      The principle hypothesis of this study is that nabilone at a dose of 0.5-1mg is as     efficacious as amitriptyline at a dose of 10-20mg, in improving sleep quality in patients     with fibromyalgia.   "
193779|NCT00381212|"     To Investigate the safety and immunologic activity of AGS-004, an autologous HIV     Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART)     with durable viral suppression.   "
193780|NCT00381225|"     To study the feasibility of Radiofrequency ablation (RFA) via ultrasound guidance in the     treatment of papillary thyroid cancer (PTC).   "
193781|NCT00381238|"     This is an open-label extension to study 49653/461, to assess the long-term safety of     rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's     Disease.   "
193782|NCT00381251|"     This study will compare the bioequivalence of two new investigational combination     formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed     formulation of Premarin and medroxyprogesterone, Prempro™.      Prempro is indicated for use after menopause in women with a uterus to reduce moderate to     severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around     the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The     purpose of this study is to determine if these new formulations of Premarin and MPA provide     the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.   "
193783|NCT00381264|"     This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain     in subjects experiencing pain due to Multiple Sclerosis.   "
193784|NCT00381277|"     The effect of sports drinks on the tendency to form kidney stones has not been assessed.     Patients will drink 1 liter a day of 2 sports drinks and collect urine to determine changes     in urine chemistry that may decrease the risk of forming stones.   "
193785|NCT00381290|"     The purpose of this study is to compare the effects of a calorie-restricting diet, exercise,     and a combination of both in reducing knee inflammation and compressive forces in obese and     overweight adults with knee osteoarthritis (OA).   "
193788|NCT00381329|"     The Pennsylvania Adolescent Smoking Study (PASStudy) will evaluate the effectiveness of     Motivational Interviewing (MI) compared to Structured Brief Advice (SBA) to reduce cigarette     smoking among adolescents who smoke. MI is a brief 5 session client-centered     psychotherapeutic style intended to increase the probability that a person will enter into,     continue and adhere to a specific change strategy. This will be compared with SBA, which     implements Best Practice Guidelines (i.e., 5 A's and 5 R's) and assists participants in     accessing the best available resources for smoking cessation.   "
193789|NCT00381342|"     This Phase 3 trial is designed to compare the effects of twice-daily exenatide and     twice-daily placebo with respect to glycemic control in drug-naive patients with type 2     diabetes treated with diet and exercise.   "
193790|NCT00381355|"     The objective of the proposed large, high-intensity, randomised controlled trial is to     evaluate the real-life effectiveness of providing a written action plan to asthmatic children     discharged from the emergency department (ED) or hospital on the short-term adherence to     written recommendations (including medication, attendance to asthma education and medical     follow-up). main outcome is adherence to prescribed inhaled preventive medication measured by     an electronic counter. Secondary outcomes include attendance to asthma education and to     medical follow-up, serving by pharmacy of prescription of oral steroids, as well as asthma     control measured by questionnaire (Asthma Quiz for Kidz),2 use of rescue ß2-agonists, relapse     to emergency room.   "
193791|NCT00381368|"     The purpose of the study is to determine the efficacy and safety of a three time repeated     loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients     with painful skeletal metastases.   "
193792|NCT00381381|"     This study attempts to differentiate the clinical responses of Choline Acetyltransferase and     Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.   "
193793|NCT00381394|"     Sitamaquine is an 8-aminoquinoline which is being developed as an oral treatment for visceral     leishmaniasis (VL). Pre-clinical and subsequent clinical investigations have demonstrated     oral efficacy against Leishmania donovani. The purposes of this study are to characterise the     pharmacokinetic profile of sitamaquine, administered orally, and to determine if the     pharmacokinetic profile is affected by administration with food. The study is also designed     to further characterise the safety and tolerability of sitamaquine compared with amphotericin     B, particularly in reference to renal, hepatic and cardiac adverse events, prior to     initiation of phase III studies. Finally the study will investigate the efficacy of a 21 day     treatment course. Previous studies have used 28 days dosing, but parasitological evidence     from one study suggests that shorter courses may be effective.   "
193794|NCT00381407|"     This study will evaluate the effectiveness of organizational skills training in improving     organizational, time management, and planning difficulties in children with attention deficit     hyperactivity disorder.   "
193795|NCT00381420|"     The main objective of this study is to assess the safety and effectiveness of the     sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native     coronary artery lesions as compared to the uncoated Bx VELOCITY™ balloon-expandable stent.     Both stents are mounted on the Raptor® Stent Delivery Systems.      The secondary objective is to assess cost-effectiveness expressed in incremental cost/life     year gained or cost/quality adjusted life year gained at different time points (8 months, 1     year, 3 and 5 years).   "
193796|NCT00381433|"     AVI-4020 Injection, a phosphorodiamidate Morpholino oligomer (PMO), was found to cross the     blood-brain barrier during a study of patients with presumptive West Nile virus disease.     AVI-4065, which was designed to target HCV, is also a PMO; its ability to cross the     blood-brain barrier is unknown. In this study, a single dose of AVI-4065 will be     subcutaneously injected, and samples collected to determine if this drug crosses the     blood-brain barrier. If it does, then additional investigations could be performed in people     with severe forms of HCV disease in which the brain is affected.   "
193797|NCT00381446|"     The purpose of this study is to quantify the amount of corneal staining observed with various     marketed contact lens/multipurpose solution combinations. The hypothesis is that there are     measurable differences in the amount of corneal staining between the various combinations.   "
193798|NCT00382213|"     The purpose of this study is to determine the efficacy of treatment with olmesartan     medoxomil, an Angiotensin Receptor Blocker, compared to placebo on the blood levels of     surrogate markers of vascular inflammation for atherosclerotic disease. Patients will be     randomized to receive either olmesartan medoxomil or placebo for one year.   "
193799|NCT00382226|"     Uncontrolled glaucoma patients being treated with a prostaglandin agent alone or in     combination with adjunctive drugs in fixed or unfixed combinations, will be switched from     their current therapy to travoprost/timolol fixed combination and either Azopt or placebo   "
193800|NCT00382239|"     This study will examine the response of several doses of LY2148568 (exenatide) and assess the     effect on glucose control and safety and tolerability in Japanese patients with type 2     diabetes.   "
193801|NCT00382252|"     RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor     cells. Diagnostic procedures, such as PET scan and CT scan, may help doctors measure the     patient's response to treatment.      PURPOSE: This clinical trial is studying PET scan and CT scan to see how well they work in     evaluating response to treatment in patients undergoing radiofrequency ablation for lung     metastases.   "
193838|NCT00382733|"     The purpose of this study is to evaluate the effectiveness of oral topotecan and how well the     chemotherapy is tolerated (any side effects) when it is given in different dose levels. The     study will also collect information on how the medication is being broken down and absorbed     in the body and how quality of life is affected during treatment.   "
193839|NCT00382746|"     CHF patients will be monitored using EarlySense ES-16 device and will simultaneously fill     diaries and log their weight daily. The data collected and analyzed by the ES-16 device will     be correlated with the CHF status data.   "
193840|NCT00382759|"     The study aimed to evaluate the efficacy of a nonmyeloablative conditioning consisting of     fludarabine and total body irradiation in patients older than 60 years of age   "
193898|NCT00383513|"     Epratuzumab is an investigational antibody designed to help treat Systemic Lupus     Erythematosus (SLE). The purpose of the study is to obtain additional long-term information     regarding the safety and efficacy of continued maintenance-cycle administrations of     Epratuzumab.   "
193802|NCT00382265|"     Urolithiasis is a disease that effects 12% of the population and its incidence is growing. In     the US there are over 1.1 million visits annually to Emergency Departments for renal colic.     The disease is extremely painful, often requiring large amounts of narcotic analgesia, and     results in lost work days. Moreover, up to 30% of patients may eventually require lithotripsy     or surgical removal of the stone. Currently there are no medical interventions other than     analgesia which are offered to patients.      Based on encouraging results from several small European clinical studies, the researchers     hypothesize that the administration of tamsulosin to patients with symptomatic urolithiasis     will enhance stone passage, and reduce both the time to recovery and the need for surgical     intervention or lithotripsy. The researchers will conduct a study by identifying and     recruiting patients presenting with urolithiasis in the emergency departments of four     institutions.      A total of 500 consenting subjects will be randomly assigned to one of two groups:        1. tamsulosin for a maximum of 28 days;        2. placebo for a maximum of 28 days.      In addition, both groups will receive standard analgesic therapy.      The study team, which will be blinded to treatment status, will monitor each subject's     clinical progress and outcome. The primary objectives of this study are:        1. to determine if tamsulosin is effective, and        2. to evaluate the safety of the therapy.      Another objective is to identify the most appropriate clinical subgroup(s) for treatment.      If the therapeutic benefits observed in smaller clinical studies are replicated,     administration of these medications should produce several benefits, including:        1. a reduction in time to pain free recovery and hence a more rapid return to employment;        2. decreased requirements for narcotic analgesia;        3. less need for urological out-patient clinic follow-up;        4. decreased need for surgical intervention or lithotripsy; and        5. substantial cost savings.      If this therapy is beneficial, it will represent a major advance in the treatment of     urolithiasis. This objective is a major stated goal of the NIDDK Clinical Urology Program,     which has a stated mission to improve the treatment of urolithiasis.      Kidney stones are a major public health issue, and one person in eight will be affected by     the disease. If the hypothesis is verified, the researchers will provide the first medical     therapy ever for this disease. This therapy, if effective, will reduce the amount of time a     patient is off work because of the pain from the disease, and may also reduce the need for     expensive and time-consuming surgical treatments.   "
193803|NCT00382278|"     It is a fase I/II clinical study to evaluate feasibility, safety and kinetics of cellular     therapy with bone marrow-derived mononuclear cells (ABMMC) in patients with liver cirrhosis.     All the patients have moderate liver disfunction and a waiting time expectancy of liver     transplantation longer than 12 months due their low MELD score. The ABMMC are labeled with     99mTc and infused through the hepatic artery. Scintigraphy is performed 2 and 24 hours after     infusion. Patients are submitted to frequent clinical, laboratorial and image evaluation     during the follow up period of 12 months.   "
193804|NCT00382291|"     This study measures the occurrence of certain side effects linked to antidepressant use and     evaluates the effectiveness of the medication sertraline plus cognitive behavioral therapy to     treat people with obsessive-compulsive disorder.   "
193805|NCT00382304|"     Approximately 24 patients will be entered into this study taking place in Canada. The aim of     this study is to determine if an investigational drug is absorbed (taken up) in patients with     C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition     to current standard antibiotic treatment so that all patients will receive active medication.     All study related care is provided including doctor visits, physical exams, laboratory tests,     and study medication. The total length of participation is approximately 7 days.   "
193806|NCT00382317|"     This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal     angiography.   "
193807|NCT00382330|"     The purpose of this study is to determine if regular and daily repeated application of the     ciclopirox lotion to vulva will make the precancerous lesion(s) shrink or even disappear.   "
193808|NCT00382343|"     The aim of this study is to assess the effectiveness of antibiotic prophylaxis in preventing     pyelonephritis and in avoiding the appearance of new scars in a sample of children under 36     months with vesico-ureteral reflux (VUR).   "
193809|NCT00382356|"     The study is to determine the safety and efficacy of Dutasteride in patients who have failed     Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H).   "
193810|NCT00382369|"     Vocal cord paralysis is a common cause of congenital stridor and airway obstruction. In this     study we plan to identify the genetic locus of the genes in two extended families who suffer     of the disease.   "
193811|NCT00382382|"     Using a new and more detailed approach to diffusion tensor imaging (DTI) recently developed     in our lab, the investigators hope to learn more about irregularities in the brain that are     related to autism. The investigators are especially interested in brain regions that     contribute to repetitive behaviors in children with autism. Repetitive behaviors include     stereotyped motor movements (hand-flapping), self-injurious behaviors (head hitting),     compulsions (lining up toys), insistence on things staying the same, and difficulty with     change. These behaviors often interfere with learning, can disrupt daily functioning, and can     lead to other behavioral problems. Two specific aims will be accomplished:      Aim 1: To examine the integrity of white matter pathways in high functioning autistic     children. The investigators hypothesize that autism is associated with specific white matter     abnormalities in the cerebellum and other motor circuits. Additionally, the investigators     expect to confirm and expand on previous reports of cerebral abnormalities by using newly     developed DTI methods.      Aim 2: To determine whether there is a relationship between white matter abnormalities and     the occurrence of restricted repetitive behaviors in children with autism. The investigators     hypothesize that differences in the occurrence and type of restricted repetitive behaviors     between autistic individuals are correlated with specific regional white matter     abnormalities.      Results from the proposed experiments should contribute to current knowledge of brain     abnormalities in autism and their relationship to restricted repetitive behaviors, and may be     relevant to understanding the mechanisms underlying motor deficits in this disorder.   "
193812|NCT00382395|"     Study Objective:      To establish the substantial equivalence of the SOLX Gold Shunt to commercially available     aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce     intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional     surgical treatments have failed.   "
193813|NCT00382408|"     This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the     safety and efficacy of oral DR-5001 in reducing the attack rate of febrile acute respiratory     disease caused by type-4 and type-7 adenovirus as well as determine its immunogenicity.   "
193814|NCT00382421|"     There is a lack of data on the prognostic importance of silent ischemia in totally     asymptomatic subjects without history of coronary artery disease (CAD), and, particularly, on     a possible benefit of medical therapy in such patients. SWISSI 1 therefore recruits totally     asymptomatic subjects older than 40 years of age without any history of CAD but one     cardiovascular risk factor with documented silent ischemia. Participants are randomized to     open antianginal drug therapy and risk factor control versus only risk factor management and     followed up for ≥ 10 years.   "
193815|NCT00382434|"     The Emergency Department (ED) is a unique environment in medicine, and many safety mechanisms     used in other hospital settings cannot be applied in the ED. For example, clinical     pharmacists have traditionally provided extra layers of protection to hospital inpatients by     cross-checking provider orders for appropriate dosing, contraindications, and interactions.     Because medications in the ED must be accessed immediately and are often one-time doses, the     use of central pharmacy services would introduce an unacceptable delay to the administration     of medication. Although some hospitals have programs in place in which a pharmacist responds     to the ED for cardiac arrests or trauma team activations, few have reported programs which     involve a clinical pharmacist assigned exclusively to the emergency department. Nonetheless,     published reports have asserted that ED-based pharmacists can increase patient safety.     Although this concept appears logical, no study has attempted to show that these programs     reduce potential adverse drug events in the ED. We propose to implement and optimize an ED     Pharmacist (EDP) program as a safe practice intervention in a large ED. The hospital has     provided funding for two permanent full time positions starting at the beginning of the award     period. In the initial phase interviews of physicians, nurses, pharmacists, and patients will     be conducted and the results will be used to optimize the EDP role. A large-scale chart     review study will then be conducted to evaluate whether there is a reduction in frequency of     potential and adverse drug events during times that the EDP is on duty. Staff perceptions of     the effectiveness of this program will also be evaluated. The overall goal of this initiative     is to create an effective EDP program that will decrease the rate of adverse drug events in     ED patients, and to create a toolkit to facilitate the introduction of similar programs     into other EDs. This toolkit will include a description of the formal, optimized role of the     EDP, challenges and solutions in implementation, and evidence to support the efficacy of such     a program.   "
193816|NCT00382447|"     Comparison of the researchers' standard nebulizer and a breath actuated nebulizer to examine     if breathing medication can be delivered more quickly and as effectively or more effectively     than the standard nebulizer.   "
193817|NCT00382460|"     The primary purpose of the study was to evaluate 4000 subjects with acute coronary syndrome     by comparing pravastatin 40 mg to atorvastatin 80 mg to determine if they are clinically     equivalent, and to evaluate the effectiveness of gatifloxacin therapy in reducing     cardiovascular events in combination with statin therapy.   "
193818|NCT00382473|"     The purpose of this study is to compare the effects of an 8-week aerobic training program     upon fat oxidation in vivo and markers of skeletal muscle mitochondrial content and oxidative     capacity in sedentary obese subjects with and without type 2 diabetes. We will also     investigate if mitochondrial content in muscle predicts success of weight loss.      The specific aims are:        -  To compare systemic fat oxidation rates;        -  To measure mitochondrial content in muscle before and after aerobic training;        -  To determine if decreased mitochondrial content is also associated with decreased          mitochondrial oxidative capacity;        -  To measure non-plasma fatty acid oxidation in vivo during submaximal exercise conditions          both prior and after aerobic training;        -  To determine whether increases in fat oxidation due to physical activity predict weight          loss success when a reduced calorie diet is added to a physical activity program.   "
193819|NCT00382486|"     The specific aims of this study is to improve short and long-term patient and graft survival,     to reduce the incidence and severity of allograft rejection, to reduce the incidence of     infection and to reduce and/or eventually eliminate the need for long-term immunosuppression.   "
193820|NCT00382499|"     The purpose of this study is to evaluate the efficacy of intravenous lidocaine infusion     administered during general anesthesia in:        1. Reducing length of hospital stay following total abdominal hysterectomy        2. Reducing postoperative analgesic requirement following total abdominal hysterectomy.      Hypothesis:      The addition of an intraoperative lidocaine infusion to a balanced anesthetic technique will     result in up to 50% of patients being discharged after postoperative day 2 compared with the     current 21%. Also, it will result in a 30% reduction in opiod consumption during the first 48     hours following total abdominal hysterectomy.      Assumption:      Patients in the intervention and control groups will be titrated to approximately equal     analgesia because they will self-administer enough pain-controlling medications to make their     postoperative pain experience the same.      Primary outcomes:        1. Length of hospital stay        2. Total opioid use at 48 hours postoperatively      Secondary outcomes. The following data will be collected and analyzed:        1. Intraoperative data: BIS scores (to control depth of anesthesia); intraoperative serum          lidocaine levels; intraoperative opioid use        2. Opioid use in the recovery room        3. Patient Controlled Analgesia (PCA) morphine requirements postoperatively up to 48 hours        4. Oral pain controlling medication use up to 48 hours postoperatively if IV PCA          discontinued before 48 hours        5. Verbal Analogue Scale (VAS) pain scores in recovery room and during first 2 days          post-operatively        6. Incidence of side effects that can be attributed to local anesthetic toxicity        7. Incidence of nausea and vomiting and anti-emetic use up to 48 hours postoperatively        8. Time of first flatus and first bowel movement.   "
193821|NCT00382512|"     This is a Phase I, randomized, placebo-controlled, single blind, parallel group,     single-center study designed to evaluate immune responses during and after administration of     12 weekly SC doses of 1.0 mg/kg efalizumab in subjects with moderate plaque psoriasis.   "
193822|NCT00382525|"     To construct a computerized database of national profiles and epidemiological data on     patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with     or without cardiac resynchronization therapy), implantable loop recorders and leads used     within their intended use.      Clinical variables will be analyzed in relation to device-based data and diagnostics.   "
193823|NCT00382538|"     Mid-second trimester medical terminations of pregnancy require admission to the hospital for     the length of time it takes a woman to abort. The current protocol at BMC uses intra-amniotic     digoxin injection the day prior to admission. The following day, the woman is admitted and     given sequential doses of misoprostol until delivery occurs. The average length of time     between the first dose of misoprostol and delivery is 12 hours, requiring most women to stay     overnight. This is a randomized, placebo-controlled, double-blinded study designed to     determine whether adding mifepristone significantly reduces the induction interval time (time     between starting the first misoprostol and delivery) required for a second trimester     termination.   "
193824|NCT00382551|"     To study the effect of red wine, beer and fruit juice on endothelial function in patients     with coronary Heart disease.   "
193841|NCT00382772|"     The aim of this this study is to evaluate the lot-to-lot consistency of the liquid     formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared     to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered     concomitantly with a combination childhood vaccine.   "
193825|NCT00382564|"     This study will determine the usefulness of magnetic resonance imaging (MRI) for examining     the heart or blood vessels. MRI uses a magnetic field and radio waves to produce images of     body tissues and organs. The subject lies on a table that can slide in and out of the scanner     (a metal cylinder), wearing earplugs to muffle loud noises that occur during the scanning     process. MRI of the heart and blood vessels, called magnetic resonance angiography (MRA), is     a developing diagnostic method that permits evaluation of arteries and veins without the use     of x-rays or invasive catheterization required by conventional angiography.      People 18 years of age and older with known or suspected atherosclerotic disease may be     eligible for this study.      Participants have blood tests and MRA scanning. The MRA takes about 1.5 to 2 hours. During     part of the scan, a contrast agent may be injected into a vein to brighten the images of the     heart and blood vessels. Subjects are monitored with an electrocardiogram and are asked to     hold their breath for about 5 to 20 seconds intermittently during the procedure.      A CT scan may be done to confirm the MRA findings. CT uses x-rays to produce pictures of the     heart and blood vessels. The subject lies on a bed during the scan and is given a contrast     agent through a catheter inserted into a vein. Subjects are asked to hold their breath     intermittently for about 5 to 20 seconds. A medicine called a beta blocker may be     administered to slow the heart rate.   "
193826|NCT00382577|"     The purpose of this study is to evaluate the effects of itopride in patients with heartburn.   "
193827|NCT00382590|"     Primary Objective:      1. To evaluate whether 5 azacytidine (5-aza)/valproic acid (VPA) or low dose ara-C produces     longer event free survival time in patients age > or = 60 years with untreated Acute Myeloid     Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS) who are typically ineligible for,     or not placed on, studies of new agents.      Secondary Objective:      1. To evaluate whether pre-treatment methylation/acetylation status in AML/MDS blasts     predicts response to either therapy or whether the ability of the 5 azacytidine + valproic     acid combination to induce demethylation or acetylation parallels response.   "
193828|NCT00382603|"     The objective of the study was to clinically evaluate the safety and effectiveness of a new     multi-purpose disinfecting solution for soft contact lenses in patients who experience     discomfort with their contact lenses.   "
193829|NCT00382616|"     To determine whether supplementation of omega-3 long-chain polyunsaturated fatty acid     conjugated to phosphatidylserine rather than triglycerides (fish oil) could affect     Attention-deficit/hyperactivity disorder symptoms in children.   "
193830|NCT00382629|"     The purpose of this study is to determine if BHT-3009 decreases inflammation (measured by     gadolinium enhancing MRI lesions) in the brains of people with relapsing remitting multiple     sclerosis.   "
193831|NCT00382642|"     The purpose of this study is to learn whether ondansetron is safe and effective in the     treatment of alcohol dependence. We also want to learn whether the study drug ondansetron     combined with Cognitive Behavioral Therapy will assist researchers to determine whether     having a certain gene is responsible for determining how a person benefits or does not     benefit from the use of ondansetron for alcohol dependence.   "
193832|NCT00382655|"     The goal of this project is to prevent injuries and diseases among older adults through the     development and evaluation of a novel emergency medical services (EMS)-based screening     program to identify preventable injuries and diseases and refer the identified injuries and     diseases for intervention.      To prevent injuries and diseases among older adults, this study specifically aims to:        1. Evaluate the feasibility of an EMS-based primary prevention program that screens older          adults for need of the influenza and pneumococcal vaccine and for risk of falling during          emergency medical responses in a rural setting;        2. Evaluate the outcome of the EMT-implemented screening and education program by          performing a 14-day telephone follow-up on older adults cared for by EMTs.      At the conclusion of this award, we will determine if an EMT-implemented primary prevention     program for older adults is feasible and benefits the community.   "
193833|NCT00382668|"     The primary purpose of this study is to evaluate how a person with liver impairment processes     and reacts to the study drug. Information about any side effects that may occur will also be     collected.   "
193834|NCT00382681|"     The objective of the study was to clinically evaluate the safety and effectiveness of a new     multi-purpose disinfecting solution for soft contact lenses.   "
193835|NCT00382694|"     Multiple myeloma is an incurable malignant disease which evnetuelly will relapse after     primary treatment. Clonal B-cells have been identified and in theory these cells might be     sleeping during primary treatment and be responsible for later relapse. Fluarabine has     documented effect on both resting and dividing cells including B-cells. The protocol aim at     evaluating safety and toxicity of adding fludarabine to induction chemotherapy with     cyclophosphamide and dexamethasone before high-dose melphalan with autologous stem cell     support.   "
193836|NCT00382707|"     Epileptic disease is characterised by enhanced brain excitability. Low frequency repetitive     transcranial magnetic stimulation (rTMS) can be an effective treatment for refractory frontal     epilepsy. Thought, physiological mechanisms of its effectivity are still unknown. It is yet     possible to evaluate cortical excitability and inhibition with TMS-coupled electromyography     before and after rTMS sessions ; this could provide clues for basic mechanisms of rTMS     effects on the epileptic brain. We assume that rTMS decrease brain excitability by improving     brain inhibition. Such an information could help for treating patients with both     pharmacological and non-pharmacological methods.   "
193837|NCT00382720|"     This phase II study addressed the use of docetaxel in combination with oxaliplatin with or     without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously     untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part     I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in     each arm. The optimal dose was administered in the Part II study. Participants who received     the optimal dose in each treatment arm in Part I were included in the Part II analysis     population.      Primary objective:        -  To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin          with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent          gastric cancer previously untreated with chemotherapy for advanced disease (part II).      Secondary objectives:        -  To establish the safety profile.        -  To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO)          criteria        -  To assess the Overall Survival (OS)   "
193842|NCT00382785|"     Purpose: The purpose of this project is to evaluate whether psychosocial outcomes in women     with breast cancer differ based on the format of online group support. This objective will be     addressed by the following specific aims:        1. Specific Aim #1 is to determine if there is a difference in depressive symptoms between          women with breast cancer assigned to one of two treatment conditions: moderated online          support or peer-led online support.           • H1: Women with breast cancer who participate in moderated online support will report          fewer depressive symptoms than women with breast cancer in peer led online support.        2. Specific Aim #2 is to determine if there is a difference in perceived social support          between women with breast cancer who are assigned to one of two treatment conditions:          moderated online support or peer-led online support.           • H2: Women with breast cancer who participate in moderated online support will report          greater perceived social support than women with breast cancer in peer-led online          support.        3. Specific Aim #3 is to determine if there is a difference in quality of life in women          with breast cancer who are assigned to one of two treatment conditions: moderated online          support or peer-led online support.             -  H3: Women with breast cancer who participate in moderated online support will               report better quality of life than women with breast cancer in peer-led online               support.      NOTE: Once the study began, it was obvious that we could not prevent anyone from joining a     support group, if that was her choice. We also could not control if participants joined a     second online support group or face-to-face group during the study. Therefore, we decided to     omit a usual care (no support) group. The study was completed with just two groups:     moderated and peer-support.   "
193843|NCT00382798|"     This is an adaptive Phase I study to evaluate RO5024048 in the following groups:        -  Healthy Volunteers (Part 1 - Single Ascending Dose Study) -Enrollment completed        -  Hepatitis C virus (HCV) genotype 1 infected patients who have failed interferon therapy          (Part 2- Multiple Ascending Dose Study)-Enrollment Completed        -  HCV genotype 1-infected patients who are treatment naive, to be dosed in combination          with PEG-IFN and RBV (Part 3 - Combination Dose Study)-Currently Enrolling        -  HCV genotype 2-3 infected patients who have previously been treated with interferon but          who did not respond, to be dosed in combination with PEG-IFN and RBV (Part 3 -          Combination Dose Study)- Currently enrolling      The study aims to determine if RO5024048 is safe and well-tolerated in healthy people and in     people infected with hepatitis C virus. The amount of RO5024048 in the blood will be measured     during the study and the amount of hepatitis C virus in the blood after each dose will also     be measured.      During Part 3 of the study, RO5024048 will be given with PEG-IFN and RBV, two drugs currently     used and approved for the treatment of HCV.   "
193844|NCT00382811|"     The purpose of this project is to see if weekly carboplatin compared with phenoxodiol in     combination with weekly carboplatin, is effective against late stage ovarian cancer and to     see what, if any, side-effects of treatment may result.   "
193845|NCT00382824|"     The clinical syndrome of PSP responds poorly to all available forms of therapy used in     Parkinson's Disease (PD). Currently, no effective treatment exists. Coenzyme Q10 in high     doses has been shown to be a beneficial therapy in PD and might possibly be a beneficial     therapy for PSP. This study will compare the efficacy, safety and tolerability of Coenzyme     Q10 versus placebo in patients with atypical parkinsonian syndrome, progressive supranuclear     palsy (PSP).   "
193846|NCT00382837|"     Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to     evaluate safety and long term efficacy in concert with standard SLE treatments   "
193847|NCT00382850|"     The purpose of this study is to determine whether short- and long-term outcomes are different     between open and laparoscopic Nissen fundoplication performed in children younger than 2     years of age.   "
193848|NCT00382863|"     The purpose of this study is to determine if patients in the HeartNet Ventricular Support     System with optimal medical and device therapy arm (Treatment group) show statistically     significant improvement compared to patients in the optimal medical and device therapy alone     arm (Control group) after 6 months of follow-up.   "
193849|NCT00382876|"     The infant car restraint devices are a critical part of infant safety during transportation.     The crash tolerance and the critical safety features of each seat are well established.     Infant transportation may be via a car seat or car bed. The effect of the sitting position on     the airway is a concern in an infant with poor head control. Because of this concern, car     seat tests during which oxygen saturation is measured, are performed on many low birth weight     infants before discharge from the nursery. Indeed, a number of deaths have occurred in car     seats probably related to airway obstruction. The relative effects of position on the     ventilation need to be established.      We propose to identify the relative changes in ventilation that are induced by position     change during sleep. We will collect a broad array of high quality data that will identify     these changes, and the most likely cause. Specifically, we will we screen 200 infants, with     each infant assigned to the supine position, the car bed and the car seat. The order of these     positions will be randomly assigned. Following data will be collected:        1. Relative changes in ventilation will be assessed by oxygen saturation measurement.        2. Respiratory movement will be measured in order to define the defect.        3. Once the data is collected, it will be sent for blind data analysis.        4. Once the data analysis is complete, the effect of position on ventilation will be          established.   "
193850|NCT00382889|"     The aim of this study is to reveal that inhaled corticosteroid therapy combined with a     short-acting beta2- agonist given on a symptom driven basis is as effective as traditional     asthma therapy.      Thus, three advantages will be achieved:        1. better compliance with treatment since patients will most likely have to administer the          treatment less frequently,        2. maximum pharmacological effect with the least amount of drug and        3. less economic burden on health care providers.   "
193851|NCT00382902|"     The objective of the study was to clinically evaluate the safety and effectiveness of a new     multi-purpose disinfecting solution in patients wearing silicone hydrogel soft contact     lenses.   "
193852|NCT00382915|"     This study will evaluate the differences in smoking behavior, nicotine intake, and nicotine     boost among people with schizophrenia, bipolar disorder, or no mental illness.   "
193853|NCT00382928|"     We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who     are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted     to the telemetry ward, all other treatments being constant including cardiopulmonary     resuscitation.      We hypothesize that the automatic, rapid, accurate and specific diagnostic and therapeutic     technology used in AECDs will further increase the rate of survival in patients with cardiac     arrest through rapid and automatic defibrillation, independent of operator initiation, as     compared to standard cardiopulmonary resuscitation initiated by healthcare providers.   "
193854|NCT00382941|"     The purpose of this study is to determine whether LED phototherapy using combined red and     near infrared light (approved: Ministry of Health of Russian Federation No.     29/06070997/1080-00, EUROCAT Certificate No. CP033321-IV) is effective in the treatment of     musculoligamentous lesions in physiotherapy practice   "
193922|NCT00383825|"     To evaluate graft vascularization and compare the vascularization patterns of conjunctival     autografts with amniotic membrane grafts to better understand the factors involved in     pterygium recurrence.   "
193855|NCT00382954|"     The purpose of this study is to determine the maximal tolerated dose (MTD) of bortezomib and     idarubicin given in combination to newly diagnosed AML patients >60 years or relapsed AML     patients.      Another purpose of this study is to determine the dose limiting toxicities associated with     bortezomib in combination with idarubicin in newly diagnosed AML patients >60 years or     relapsed AML patients.   "
193856|NCT00382967|"     Patients come to their doctor showing possible symptoms of a movement disorder. It is     possible that these symptoms may get worse over time. There is more than one disease that can     cause such symptoms. The most common movement disorder illnesses are Parkinson´s Disease and     Essential Tremor. Sometimes it is difficult for doctors to make the right diagnosis because     the symptoms caused by these illnesses are almost the same. On the other hand the correct     treatment for Parkinson´s Disease is different from the correct treatment for Essential     Tremor. This study aims to see whether having pictures of the brain taken with DaTSCAN can     affect the way the doctor treats these patients and whether it can affect their quality of     life directly.   "
193857|NCT00382980|"     The purpose of this research study is to compare how the body reacts to different strengths     of an experimental cell culture-grown whole virus A/H5N1 flu vaccine when given with or     without the addition of aluminum hydroxide adjuvant. Researchers will also look at how much     antibody is made to the influenza virus hemagglutinin (HA) after subjects receive the H5N1     vaccine. Three hundred healthy adults aged 18-40 years will participate for approximately 9     months, which includes screening. Participants will receive 2 doses of vaccine or placebo     injected 28 days apart. Participants will have blood samples taken up to 7 times and have 8     scheduled study visits.   "
193858|NCT00382993|"     This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient,     early-intervention evaluation of subjects who have migraine with or without aura and who     discontinued use of short acting triptan(s) within the past year due to non-response or     intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each     attack; one attack will be treated with one tablet of the Combination Product (sumatriptan     succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover     design). [Study 2 of 2]   "
193859|NCT00383006|"     Problems of self regulation, e.g. emotional dysfunction, represent a core symptom of adult     patients with traumatic childhood experiences. The study intends to evaluate the efficiency     of a 14-week group therapy for adult survivors of relational trauma in childhood. Main     interventions are psychoeducation about the sequelae of childhood trauma, teaching of skills     for affect regulation and techniques for activating resources. The hypothesis is that the     group therapy significantly improves the participant's capacity in emotion management and     self-soothing.   "
193860|NCT00383019|"     This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in     Japanese patients with POAG or OH.   "
193861|NCT00383032|"     Data from other countries have suggested that oral mifepristone used as a cervical ripening     agent may decrease induction to delivery time in midtrimester inductions. To our knowledge,     there are no trials comparing mifepristone to laminaria in a standard clinical setting with     standardized misoprostol induction protocol to examine the issue of induction to delivery     time. We hypothesize that mifepristone will work at least as well as laminaria for     midtrimester cervical ripening prior to induction of labor with misoprostol.   "
193862|NCT00383045|"     A randomized clinical trial comparing drug abuse and HIV risk reduction counseling (DC-HIV)     alone, DC-HIV combined with naltrexone maintenance, and DC-HIV combined with buprenorphine     maintenance for the treatment of heroin addicts in Malaysia.   "
193863|NCT00383058|"     The purpose of this study is to examine whether the extract of the green tea is effective on     obese women.   "
193864|NCT00383071|"     This study will determine how best to use a vaccine for generating high levels of antibodies     called immune globulins (IVIG) in people, which, in turn, can be collected and used to     develop a possible treatment for avian influenza (bird flu). Immune globulins are proteins     made by the body that attack the influenza virus. This study will use an experimental bird     flu vaccine to stimulate immune globulin production in healthy people. The vaccine is similar     to the regular influenza vaccine and has been studied in more than 450 people. This study     will use high doses of the vaccine to generate high antibody levels that can be collected for     producing the new treatment.      Healthy adults between 18 and 60 years of age who weigh at least 110 pounds may be eligible     for this study. Candidates are screened with a medical history and physical examination.      Participants are given one of three doses of the vaccine, depending on when they enter the     study. The first 25 people enrolled receive a dose of 90 micrograms (mcg). If this dose is     well tolerated, the next 25 people receive 120 mcg, and if this dose is also well tolerated,     the last 25 people receive 180 mcg. Vaccination consists of either two shots (one in the     muscle of each arm) or one shot in the buttock on four occasions. Subjects are vaccinated on     four occasions, each 4 weeks apart. On the day of each vaccination, subjects provide a blood     sample to evaluate blood counts, chemistries, and antibody levels, and to test for HIV,     hepatitis B and C, syphilis, and antibody against avian flu. For 7 days after each     vaccination, subjects keep a diary card to record any symptoms, such as pain, fever, muscle     aches, or others. At the end of the 7 days, they are contacted by study staff to report the     symptoms.      In addition to the vaccinations, subjects undergo apheresis to collect IVIG once their blood     test shows moderately high antibody levels. For this procedure, blood is collected through a     needle in an arm vein and flows through a catheter (plastic tube) into a machine that     separates the blood cells from the antibodies and protein. The antibodies and protein are     collected and the rest of the blood is returned to the body. Subjects are asked to undergo at     least three apheresis procedures.   "
193865|NCT00383084|"     The purpose of this study is to determine the effect of 3 months of daily, 30-minute     lifestyle physical activity on pain and fatigue in inactive adults with fibromyalgia (FM).   "
193882|NCT00383305|"     This is a research study of head cooling. Its goal is to determine whether cooling babies'     heads can reduce or prevent brain damage that may have resulted from temporarily reduced     oxygen supply to the brain. In this study, half of the babies (selected at random) will have     a special cooling cap with circulating water placed on their head for 72 hours to lower the     temperature of their brain. The rest of the baby's body will be maintained at a defined     temperature by a standard overhead radiant heater. The study protocol includes the taking and     analysis of blood samples, performance of brain wave tests, imaging of the brain by     ultrasound, and other tests as clinically indicated. Neurodevelopmental outcome will also be     assessed at 18 months of age.   "
193883|NCT00383318|"     The purpose of this study is to compare the demographic, metabolic, and genomic     characteristics of patients who develop severe hyperbilirubinemia to patients who never     developed a significant bilirubin level.   "
193981|NCT00384592|"     The purpose of this study is to assess how patients with gastro-oesophageal reflux disease     (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still     experiencing symptoms will benefit from a change in treatment.   "
193866|NCT00383097|"     The purpose of this study is to obtain blood (up to 90 ml or 18-teaspoonfuls on one or two     occasions) to make LMP1- and LMP2-cytotoxic T-lymphocytes and grow them in the laboratory in     such a way that they are able to attack LMP1- and LMP2-positive cells in the laboratory.      If we are successful in growing these cells and if we feel they would be helpful to the     donor, we would then give the cells back to the donor.      This trial is for patients that have a type of lymph gland cancer called Hodgkin or     non-Hodgkin lymphoma, or chronic active Epstein Barr virus (EBV) infection, which has come     back or not gone away after treatment, including the best treatment we know.      This is a research study using special immune system cells called LMP1- and LMP2-specific     cytotoxic T lymphocytes (LMP1- and LMP2-CTLs), a new experimental therapy. As in chronic     active EBV infection, some patients with Hodgkin or non-Hodgkin lymphoma show evidence of     infection with the virus that causes infectious mononucleosis (EBV) before or at the time of     their diagnosis of the Lymphoma. EBV is found in the cancer cells of up to half the patients     with lymphoma, suggesting that it may play a role in causing lymphoma. The cancer cells     infected by EBV are able to hide from the body's immune system and escape destruction. We     want to see if special white blood cells, called T cells, that have been trained to kill EBV     infected cells can survive in the patient's blood and affect EBV-positive cells. In this     present study we are trying to find out if we can improve this treatment by growing T cells     that only recognize two of the proteins expressed on lymphoma cells called LMP1 and LMP2.     These special T cells are called LMP1- and LMP2-specific cytotoxic CTLs.   "
193867|NCT00383110|"     1. Determine racial/ethnic differences in trust in physicians and mistrust of the health          care system among veterans with Type 2 Diabetes.        2. Determine the predictive power of trust in physicians and mistrust of the health care          system on personal health practices and health outcomes in a prospective cohort of          veterans with Type 2 Diabetes   "
193868|NCT00383123|"     The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms     of the immune response elicited and safety with a six month follow-up after first     vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment     Act, Sep 2007.   "
193869|NCT00383136|"     The elective(standard of care) treatment of ST - elevation acute myocardial infarction     (STEMI) currently consists of primary angioplasty with stent implantation during     administration of Abciximab, a inhibitor of GP IIb/IIIa platelet receptor.      Tirofiban is another potent inhibitor of GP IIb/IIIa platelet receptor with an efficacy on     platelet aggregation inhibition equal to or greater than Abciximab if a high dose bolus is     used, i.e. 25 microg/kg, (platelet aggregation inhibition > 90% 15 minutes after infusion).     It can therefore be hypothesized that this drug can improve the results of primary     angioplasty to the same extent as Abciximab.      The aim of this study is to compare the efficacy, in terms of myocardial reperfusion indices,     of Abciximab and high dose of Tirofiban in primary angioplasty for STEMI, both in the case of     treatment before transfer and of treatment in the catheterization laboratory during the     procedure.      The reference hypothesis for the study objective is the equivalence or the non-inferiority of     Tirofiban with respect to Abciximab.   "
193870|NCT00383149|"     The purpose of this clinical research study is to learn if ixabepilone plus cetuximab     improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic     cancer compared to historical data. The safety of this combination treatment will also be     studied.   "
193871|NCT00383162|"     This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient,     early-intervention evaluation of subjects who have migraine with or without aura and who     discontinued use of short acting triptan(s) within the past year due to non-response or     intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each     attack; one attack will be treated with one tablet of the Combination Product (sumatriptan     succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover     design). [Study 1 of 2]   "
193872|NCT00383175|"     The purpose of this study is to determine whether special reading glasses improve children's     ability to learn to read.   "
193873|NCT00383188|"     Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who     have failed at least 1 DMARD.   "
193874|NCT00383201|"     To clinically evaluate the effect of a new multi-purpose disinfecting solution compared to a     marketed multi-purpose solution on wettability of soft contact lenses worn for 30 days.   "
193875|NCT00383214|"     The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard     treatments for patients with SLE.   "
193876|NCT00383227|"     Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre-     /haemodialysis patients aged ≥15 years   "
193877|NCT00383240|"     This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled,     parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate     (F)[MF/F] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week     double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily     (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under     the Curve From 0 to 12 Hours [AUC](0-12 hours) of the Change From Baseline to the Week 12     Endpoint      in Forced Expiratory Volume in One Second (FEV1) [Time Frame: Baseline to Week 12] and     Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.   "
193878|NCT00383253|"     Methods study to characterize early indicators of weight loss in people.   "
193879|NCT00383266|"     This is a study of an investigational agent, pemetrexed, in combination with a standard     chemotherapy drug, carboplatin, for treatment of patients with metastatic esophageal cancer.   "
193880|NCT00383279|"     RATIONALE: Finding out which problems affect employment in survivors of gynecologic cancer     may help in planning cancer treatment and improve the quality of life of future cancer     survivors.      PURPOSE: This research study is looking at ways to improve employment in patients who have     survived cervical cancer, uterine cancer, or ovarian cancer.   "
193881|NCT00383292|"     The primary purpose of this study is to determine the objective response rate (complete and     partial response) for patients who receive LY573636 after one prior systemic treatment for     unresectable or metastatic melanoma.   "
193982|NCT00384605|"     A 1 year worldwide study in obese and overweight patients to assess the safety and effect on     body weight of an investigational weight loss drug.   "
193884|NCT00383331|"     This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine     Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in     patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity     respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is     reasonable to investigate the most optimal schedule for this combination, and which     combination is associated with the most anti-tumor activity in the phase II arena.   "
193885|NCT00383344|"     The purpose of this study will permit to determine the role of FDG PET/CT to diagnose Crohn     Disease and recurrence of Crohn disease after having compared results of PET/CT's with     results of exams routinely performed(colonoscopy and bowel follow through).   "
193886|NCT00383357|"     The purpose of this project is to examine the impact of sleeping pills and waking up in the     middle of the night on walking balance and cognitive function, to identify risk factors for     falls in older adults. A significant percentage of falls, approximately 33 to 52 percent,     occur during the nighttime and morning hours when people are normally sleeping; therefore, it     is possible that sleep and sleeping medication related impairments in balance may contribute     to this risk.   "
193887|NCT00383370|"     To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF     Trap.   "
193888|NCT00383383|"     Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre-     /haemodialysis patients aged ≥15 years.   "
193889|NCT00383396|"     To Determine if topical cyclosporine 0.05% BID prevents recurrent inflammation and improves     comfort in eyes with pterygia.   "
193890|NCT00383409|"     Multivitamins (MVi) are broadly used by cancer patients to improve overall health and energy.     Fatigue is a common symptom in cancer patients including those receiving radiation therapy.     We conducted a trial of MVi versus placebo in patients with breast cancer (BC) undergoing     radiation therapy (Rxt) to evaluate if MVi would affect fatigue and quality of life. We     randomized patients at the beginning of Rxt treatment to either placebo or Centrum Silver®     (Wyeth-Whitehall laboratory). At the middle of the radiation treatments patients were     switched from placebo to MVi and vice versa. Patients answered to the EORTC QLQ C-30 quality     of life (QOL) and Chalder Fatigue Questionnaires at the beginning, the time of switching and     at the end of Rxt. We found that both groups experienced significant decreases in general and     physical fatigue at the end of the course of placebo compared to the assessment prior to this     treatment. We also observed significant improvements in functional and symptoms in the     patients on placebo. When we compared different groups of patients we also observed     significantly lower rates of physical and general fatigue in the patients who had just     finished a course of placebo as compared to patients finishing course of MVi. We conclude     that MVi do not improve radiation related fatigue, and may in fact have a deleterious effect     on fatigue and decrease QOL in patients with BC undergoing Rxt.   "
193891|NCT00383422|"     The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone     mineral density (bone strength).   "
193892|NCT00383435|"     This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study     evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler     (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID     and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic     obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated      subjects who will not participate in the safety extension will be discontinued      and will have their Final Visit at Week 26. Subjects who continue into the      26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by     the mean change from Baseline to Week 13 in area under the forced expiratory volume in one     second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12hr]) and change from     Baseline to Week 13 in AM predose FEV1.   "
193893|NCT00383448|"     Hematopoietic stem cell transplantation has proven effective therapy for individuals with     adrenoleukodystrophy (ALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy     (GLD, or Krabbe disease). This protocol also considers other inherited metabolic diseases     such as, but not limited to, GM1 gangliosidosis, Tay Sachs disease, Sanfilippo syndrome or     Sandhoff disease, I-cell disease (mucolipidosis II).      For patients with advanced or rapidly progressive disease, the morbidity and mortality with     transplantation is unacceptably high. Unfortunately, there are no viable alternative     therapeutic options for these patients; if transplantation is not performed the patients are     sent home to die. Our group at Minnesota has developed a new protocol incorporating     transplantation using a reduced intensity conditioning regimen designed to decrease toxicity     associated with the transplant procedure. This regimen will make use of the drug clofarabine,     which has lympholytic and immune suppressive properties without the neurologic toxicity     observed in the related compound, fludarabine, commonly used for transplantation. In     addition, several agents providing anti-oxidant and anti-inflammatory properties will be used     to assist in the stabilization of the disease processes. This revised transplant protocol     will test the following: 1) the ability to achieve engraftment with the reduced intensity     protocol, 2) the mortality associated with transplant by day 100, 3) patient outcomes, based     on differential neurologic, neuropsychologic, imaging and biologic evaluations prior to     transplantation and at designated points after transplantation (day 100, 6 months, 1, 2 and 5     years). Additional biologic studies will include pharmacokinetics of clofarabine and     mycophenolate mofetil (MMF). In addition, for patients undergoing lumbar puncture studies,     cerebrospinal fluid (CSF) will be requested for determinations of biologic parameters.   "
193894|NCT00383461|"     RATIONALE: Computer-based stop smoking programs may assist doctors in helping patients stop     smoking.      PURPOSE: This randomized clinical trial is studying how well a computer-based stop smoking     program works in assisting doctors in helping adults stop smoking.   "
193895|NCT00383474|"     This phase I trial is studying the side effects and best dose of tipifarnib and bortezomib in     treating patients with acute leukemia or chronic myelogenous leukemia in blast phase.     Tipifarnib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Giving tipifarnib together with bortezomib may kill more cancer     cells.   "
193896|NCT00383487|"     To determine whether, in this patient population, treatment with calcitriol and Naproxen is     more effective in delaying the growth of prostate cancer than treatment with calcitriol alone     as seen in historical controls.   "
193897|NCT00383500|"     To compare the effectiveness of usual treatments for lymphedema [massage and elastic     compression sleeve, instituted at-risk and before the development of swelling (lymphedema)],     compared to the use of a newly-marketed device, the Flexitouch, which electronically     simulates the effect of massage upon lymph flow.   "
194035|NCT00385671|"     To test the non-inferiority of duloxetine monotherapy as a treatment for the management of     diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who     have not had an adequate response to gabapentin.   "
193899|NCT00383526|"     Vaccination against influenza is a high priority for the elderly population who present the     highest morbidity and mortality rate. However, due to their weak antibody response an     improvement of the immune response to influenza vaccination remains an unmet medical need.     The purpose of an investigational influenza vaccine candidate administered by an alternate     route is to improve immune responses to the vaccine in the elderly population, which could     provide additional reductions in influenza-associated morbidity and mortality in this     population.      Primary Objective:      To demonstrate that the investigational vaccine induces a better immunogenicity than the     reference vaccine in terms of seroprotection rate after the first vaccination.      Secondary Objectives:      Immunogenicity:      To describe the antibody persistence induced by both vaccines at 3, 6, and 12 months after     the first vaccination in a subset of subjects.      To describe the immunogenicity of the investigational vaccine after each vaccination using     parameters defined in the European Medicines Agency (EMEA) Note for Guidance     (CPMP/BWP/214/96) specific to elderly subjects.      Safety:      To demonstrate the tolerance of the investigational vaccine after the first vaccination, in     terms of pre-defined solicited systemic reactions.      To describe the safety profile after each vaccination. To describe the effect of repetitive     injections on the safety profile.   "
193900|NCT00383539|"     The primary objective of this trial is to demonstrate the equivalence, in terms of     immunogenicity, of three different industrial lots of the investigational vaccine thereby     supporting consistency of the manufacturing process.      Secondary Objectives:      Immunogenicity      To demonstrate that the investigational vaccine induces an immune response at least as good     as the one induced by the reference vaccine, in terms of antibody titers.      To assess the immunogenicity of the investigational vaccine using parameters defined in the     European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96).      Safety:      To demonstrate that the investigational vaccine is at least as well tolerated as the     reference vaccine, in terms of defined safety profile.      To describe the safety profile after vaccination.      Comfort of the vaccination assessment:      To assess the pain immediately after the injection using a Verbal Rating Scale. To describe     the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire:     the Vaccination Comfort Questionnaire.   "
193901|NCT00383552|"     This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled,     parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate     (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind     Treatment Period, participants will receive open-label (OL) MF MDI 100 mcg twice daily (BID)     for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by the Area Under the     Curve from 0 to 12 hours [AUC](0-12 hours) of the change from Baseline to the Week 12     Endpoint in Forced Expiratory Volume in One Second (FEV1) and by the time-to-first severe     asthma exacerbation across the 26-week treatment period.   "
193902|NCT00383565|"     FR901228 may stop the growth of cancer cells by blocking some of the enzymes needed for cell     to grow and by blocking blood flow to the cancer. This phase II trial is studying how well     FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.   "
193903|NCT00383578|"     This study is designed to demonstrate the efficacy and safety of vildagliptin compared to     metformin in elderly drug naive patients with type 2 diabetes   "
193904|NCT00383591|"     Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed     primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in     subjects with anti-HBs antibody titres < 10 mIU/ml at previous timepoint. The study also     evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.   "
193905|NCT00383604|"     To better understand the mechanisms leading to lymphedema development in breast cancer     survivors, and the implications for potential innovative approaches to the screening,     prevention and treatment of this condition.   "
193906|NCT00383617|"     The purpose of this study is to determine which of the proposed screening parameters or which     combination of screening parameters perform best in daily clinical practice for making the     diagnosis of axial Spondyloarthritis (SpA)in patients with chronic low back pain.   "
193907|NCT00383630|"     Heart failure is a condition in which the heart is unable to pump enough blood to the body's     other organs. A heart transplant may be necessary for some individuals with end-stage heart     failure. Left ventricular assist devices (LVADs) can assist the heart in pumping blood, and     are commonly used until a donor heart becomes available. Bone marrow cells injected into the     heart may improve heart function and may lead to earlier LVAD removal. The purpose of this     study is to evaluate the safety and effectiveness of injected bone marrow cells in improving     heart function in individuals with LVADs who are awaiting heart transplants.   "
193908|NCT00383643|"     The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate     (Xyrem®) and zolpidem tartrate (Ambien®) in treating chronic insomnia. We will compare the     efficacy of sodium oxybate with zolpidem tartrate (Ambien®), and compare the efficacy of each     of these two medications with placebos.   "
193909|NCT00383656|"     The purpose of this study is to explore the effects of synthetic gonadotropin-releasing     hormone (GnRH) upon the pituitary and ovaries of women with infertility. Women diagnosed with     GnRH deficiency, hypothalamic amenorrhea or acquired hypogonadic hypogonadism, will     participate in this study. It is hoped that administration of GnRH will lead to proper     stimulation of the pituitary gland and to normal ovulation and menstruation.      **WE ARE CURRENTLY RECRUITING ONLY WOMEN WITH A DIAGNOSIS OF IDIOPATHIC HYPOGONADIC     HYPOGONADISM (IHH)**      Pulsatile GnRH has been approved by the FDA for use in women with primary amenorrhea due to     complete GnRH deficiency. The overall goals of this protocol are to continue to use pulsatile     GnRH in GnRH-deficient and other anovulatory women for ovulation induction and to examine     specific physiologic hypotheses, which can only be addressed in this patient population.   "
193910|NCT00383669|"     This study is a double-blind randomized clinical trial, conducted to examine the effects of     multivitamins (including B, C, and E) on HIV disease progression among HIV-positive Tanzanian     adult men and women taking highly active anti-retroviral therapy (HAART).   "
194051|NCT00385892|"     This safety study was carried out to investigate to what extent the use of an abdominal     binder influences IAP. The study was designed as a comparative cross-over study measuring     bladder pressure.   "
193911|NCT00383682|"     Persistent pain occurs in 50-85 percent of patients who experience the amputation of an     extremity. This study will compare the effectiveness of morphine and mexiletine to placebo in     the treatment of postamputation pain.      It is hypothesized that the effects of opioids and mexiletine on behavior and mental     functioning in patients with postamputation pain are unlikely to be significant barriers to     the clinical use of the drugs.   "
193912|NCT00383695|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Giving chemotherapy and radiation therapy with or     without cetuximab before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed. It is not yet known whether giving oxaliplatin,     capecitabine, and radiation therapy is more effective with or without cetuximab when given     before surgery in treating rectal cancer.      PURPOSE: This randomized phase II trial is studying oxaliplatin, capecitabine, and radiation     therapy to compare how well they work with or without cetuximab in treating patients     undergoing surgery for high-risk rectal cancer.   "
193913|NCT00383708|"     The main aim of this study is to assess the efficacy of the co-administration of lanreotide     Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant     (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a     week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the     percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the     end of the co-treatment period.   "
193914|NCT00383721|"     This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study     evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler     (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID     and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic     obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated     subjects who will not participate in the safety extension will be discontinued and will have     their Final Visit at Week 26. Subjects who continue into the 26-week safety extension will     have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline     to Week 13 in area under the forced expiratory volume in one second concentration time curve     from 0 to 12 hours (FEV1 AUC[0-12hr]) and change from Baseline to Week 13 in AM predose FEV1.   "
193915|NCT00383734|"     Treatment of facial lipoatrophy with dermal injections polylactic acid (Newfill TM) is a safe     procedure and has been now widely used with a good efficacy. However, this therapy is not     effective in all treated patients and the benefit of the injections may decrease with time     necessitating re-injections several months after the first sets of injections. In this study     we would like to compare the efficacy and safety of Eutrophill(polyacrylamid gel), a     resorbable filler compound versus Newfill in a comparative, randomised, multicenter trial.     Primary endpoint will be the self-perception by the patient with a visual analogue scale (VAS     index). Secondary endpoints are a quality of life questionnaire (MOS-HIV), the a-NBC     questionnaire (perception by the patient and by the doctor of the severity of the     lipoatrophy), the measure of the dermal thickness and cheek skin fold as assessed by the     Skinfold Caliper, the ordering of digital photographs and the evaluation of the dermal     thickness by CT scan.   "
193916|NCT00383747|"     Patients with schizophrenia have a variety cognitive deficits and nicotine has been shown to     normalize some of these deficits. The purpose of this study is to investigate the effects of     nicotine on cognition in schizophrenia.We will evaluate the effects of transdermal nicotine     compared with placebo for attentional impairments in non-smokers with schizophrenia and     controls.   "
193917|NCT00383760|"     This phase II trial is studying how well E7389 works as second-line therapy in treating     patients with locally advanced, unresectable, or metastatic pancreatic cancer. Drugs used in     chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing.   "
193918|NCT00383773|"     Patients with Central Retinal Vein Occlusion will undergo vitrectomy, a small needle of about     71 micron will enter a branch retinal vein and TPA will be injected into the obstracted vein.   "
193919|NCT00383786|"     This study, conducted at the NIH and the Mount Sinai School of Medicine, will examine the     effectiveness of a substance P or NK1 antagonist study drug known as GR205171 in treating the     symptoms of posttraumatic stress disorder (PTSD).      People between 18 and 65 years of age who have been diagnosed with PTSD may be eligible for     this study. Participants undergo the following tests and procedures:      Treatment: Patients are tapered off current ineffective medications over 1 to 2 weeks. All     participants receive placebo (sugar pill) at the start of the study. At some point within the     first 3 weeks of the study, they are then randomly assigned either to take GR205171 or to     continue with placebo for the remainder of the 10-week treatment period.      Clinic visits: Patients come to the clinic once a week during treatment. The following     procedures are done at various visits.        -  Interviews, self report questionnaires and psychiatric rating scales at every visit.        -  Physical examination, blood and urine tests. Blood is drawn up to 10 times during the          study.      Follow-up visits continue for up to 3 months after the end of the study, during which     patients are offered standard clinical treatment.   "
193920|NCT00383799|"     The purpose of this study is to determine whether intravenous amiodarone has less cardiac     significant adverse events compared to intravenous procainamide in the acute treatment of     haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably     ventricular origen.   "
193921|NCT00383812|"     1. Primary objectives           a. To evaluate the Effects of intravitreal Bevacizumab on polypoidal choroidal          vasculopathy(PCV)        2. Secondary objectives             1. To assess the changes in visual acuity             2. To assess the change in lesion characteristics of PCV                  -  size of PCV                  -  fluorescein leakage                  -  foveal thickness             3. To investigate the safety of intravitreal Bevacizumab in patients with PCV             4. To assess the effect of intravitreal Bevacizumab on the recurrence rate and the the               incidence of submacular hemorrhage in patients with PCV   "
193923|NCT00383838|"     Alcohol use among youth continues to be a major concern for this nation, with a large     proportion of adolescents increasing their alcohol consumption as they transition from the     6th to the 8th grade. Although many adolescents experience alcohol-related problems, few     actually seek help or treatment. This may be because traditional intervention approaches are     not well suited for this age group. It is important to understand where adolescents turn to     when they want to get help. The current project focuses on developing an alcohol intervention     program for younger adolescents. We will conduct biannual surveys at two middle schools to     assess alcohol and drug use patterns over three years. In years 2 and 3, we will implement an     intervention in one of the schools.We will examine whether the intervention has an impact on     subsequent alcohol use.   "
193924|NCT00383851|"     This is a multicenter, randomized, phase II study to evaluate the safety and efficacy of oral     ATN-224 plus temozolomide in patients with advanced melanoma. Patients will be randomized     (1:1) between temozolomide and ATN-224 and temozolomide followed by ATN-224. Patients     assigned to the sequential treatment group will receive temozolomide until progression of     disease is documented and then receive ATN-224 as a single agent until documentation of     progression of disease using the last tumor assessment on temozolomide therapy as the     baseline assessment.   "
193925|NCT00383864|"     The purpose of this study was to evaluate the efficacy (and safety) of antiviral therapy in     patients with chronic hepatitis C after liver transplantation. The only approved drugs for     treatment of hepatitis C are pegylated interferon and ribavirin.   "
193926|NCT00383877|"     This trial is conducted in China. This trial aims for a comparison of the effect on glycemic     control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily     at bedtime as add-on to oral anti-diabetic drug(s).   "
193927|NCT00383890|"     The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus     placebo used for sedation during elective awake fiberoptic intubation.   "
193928|NCT00383903|"     The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for     concomitant administration with EPI vaccines to infants in South Africa.   "
193929|NCT00383916|"     A study comparing 2 different investigational formulations of pantoprazole in healthy adults.   "
193930|NCT00383929|"     In this study it is intended to compare the blood pressure lowering effect of the combination     of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg and the     combination of candesartan 32 mg and HCT 12.5 mg to that of candesartan 32 mg alone in     patients whose blood pressure is not well controlled on candesartan 32 mg monotherapy. The     Primary Objectives are to compare sitting BP lowering effect of candesartan/HCT 32/25 mg and     candesartan/HCT 32/12.5 mg with that of candesartan 32 mg, respectively.   "
193931|NCT00383942|"     The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs     extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion     of patients delivered by cesarean section for fetal intolerance of labor versus vaginal     delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI     catheter are less likely to undergo cesarean section for fetal intolerance of labor when     compared to women who receive misoprostol.   "
193932|NCT00383955|"     Coronary artery disease (CAD) is a silent killer that may go undetected for years. It is the     leading cause of death with no limitation to geographic boundaries accounting to about 16.7     million deaths world wide. Different studies have shown that South Asians populations are     more prone to CAD where it is emerging as an epidemic. According to a study conducted in     Karachi it is estimated that the overall prevalence of cardiovascular diseases in Pakistan is     26.9% with 23.7% in men and 30.0% in women. However tools for measuring CAD have not being     adequately validated. This study is designed to develop screening tools and to determine test     characteristics of Rose Questionnaire and Minnesota Coded ECG alone and in combination for     diagnosis of CAD, using MPI as gold standard in Pakistan.   "
193933|NCT00383968|"     Prevention of progressive renal disease needs a clear understanding of prevalence of early     stage of chronic kidney disease in a community. Even in developed countries most subjects in     early stages of chronic kidney disease go largely undiagnosed and untreated. Targeted     screening could identify a greater numbers of individuals at risk then a general public     screening (11). It is economically more feasible to perform in a country like Pakistan.     Hypertension and diabetes are highly prevalent in South-Asia.It is anticipated that if target     screening of hypertensive population is performed especially of an age group in which     intervention might be expected to have maximal benefit it will not only help to identify from     a large number of patients with essential hypertension destined to develop or in the course     of advancing towards end stage renal disease but will also unearth mislabeled “essential     hypertension” that have underlying primary renal disease. This later group may belong to     socio-economic disadvantaged population who have limited access to health care and have never     been investigated properly. The aim of the Study is to detect sub-clinical chronic kidney     disease in hypertensive patients at community level and to identify associated risk factors.   "
193934|NCT00383981|"     To investigate whether exposure to Al, Ga, In, As, and Sb induces lipid peroxidation in     humans. Whole blood and urine levels of 170 workers were analysed by use of ICP-MS. MDA, the     product of lipid peroxidation was determined by HPLC   "
193935|NCT00383994|"     The goal of this clinical research study is to find out if giving a boost of natural killer     (NK) cells from a donor combined with Rituxan (rituximab), can help to control disease in     patients who have already received an allogeneic stem cell transplant. The safety of this     treatment will also be studied. Participants have recurrent chronic lymphocytic leukemia     (CLL) or lymphoma after non-myeloablative stem cell transplantation.      Primary Objectives:      1.0 To determine the safety of Natural Killer (NK) cells and Rituximab +     rhu-Granulocyte-macrophage colony-stimulating factor (GMCSF) in patients with persistent or     recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation.      2.0 To determine factors associated with response.   "
193980|NCT00384579|"     This study will test the hypothesis that Botulinum toxin B (Myobloc®) treatment reduces pain     and disability in subjects suffering from acute low back pain due to an identifiable muscle     strain or back trauma occurring 3 to 6 weeks prior to enrollment. The study will also     delineate the duration of medication effect and control for any placebo or mechanical     trigger-point injection effect by employing a prospective, double-blind, placebo-controlled     design.   "
193936|NCT00384007|"     The purpose of this study is to compare a standard surgical procedure, open surgical     microdiscectomy, used primarily to relieve leg pain and repair disc herniation to a newer     surgical procedure, hydrodiscectomy with Spinejet®. The study will examine how well each     procedure reduces subject pain and disability over a one-year period. Magnetic resonance     imaging (MRI-use of a magnetic field to produce an image) of the lower spinal column taken     before and after surgery will also be looked at to determine what physical changes have taken     place over the course of a year. Subjects enrolled in this study will also be asked to keep     track of their medical expenses related to treating their back pain to see if the surgeries     being compared reduce out of pocket expenses.   "
193937|NCT00384020|"     The purpose of this study is to understand how genetic polymorphisms influence the efficacy     and side effect profiles of Paroxetine and Escitalopram for major depression treatment.   "
193938|NCT00384033|"     The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS     SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.   "
193939|NCT00384046|"     The purpose of this study is to examine whether the transdermal testosterone system (TTS) is     effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in     postmenopausal women who are on transdermal estrogen.   "
193940|NCT00384059|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of a     13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given     concomitantly with routine paediatric vaccines in the United Kingdom.   "
193941|NCT00384072|"     The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to     placebo on bone mineral density after 6 months of therapy in a population of postmenopausal     Asian women.   "
193942|NCT00384085|"     The primary objectives were:        -  To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra®          (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of          patients achieving target glycemic control (as measured by hemoglobin A1c [HbA1c] <7.0%)          at Week 60        -  To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection          (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from          Baseline to Week 60 in HbA1c   "
193943|NCT00384098|"     Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study     drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the     efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque     psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily     for 12 weeks.   "
193944|NCT00384111|"     This study will treat follicular lymphoma patients who have not received previous treatment     with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will     receive only R-CVP. The two patient groups will be compared to determine if Zevalin given     after R-CVP therapy provides greater benefits than receiving no additional anti-cancer     therapy after R-CVP.   "
193945|NCT00384124|"     -  Double blinded, randomized, placebo controlled trial of imiquimod for the treatment of          histologically proven Bowens disease of the head and neck.        -  Null hypothesis: No difference in histologic clearance rates of patients with head or          neck Bowens treated with imiquimod versus placebo.        -  Outcome: Histologic clearance of Bowens disease at T=14 weeks.   "
193946|NCT00384137|"     Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based     immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg)     basis from a Prograf® based immunosuppressive regimen.   "
193947|NCT00384150|"     This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an     investigational drug called galiximab in combination with an approved drug called rituximab     in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study     114-NH-301 with a time-to-progression >=6 months.   "
193948|NCT00384163|"     Pulmonary valve replacement in the adult population is an uncommon operation. The majority of     native valve pathology in adults involves the mitral, aortic, and occasionally tricuspid     valves. On the other hand, right ventricular outflow tract and pulmonary valve disease is     quite common in children, especially with tetralogy of fallot, truncus arteriosus, pulmonary     atresia/ventricular septal defect, and double outlet right ventricle. Unfortunately, right     ventricular pathology often develops in adulthood as a result of pulmonary insufficiency or     pulmonary stenosis created by previous childhood operations. Without the valve size     constraints present at prior operations, these patients can be well-served by the placement     of adult-sized bioprosthetic valves. There are limited descriptions in the adult cardiac     literature of the actual technique of pulmonary valve replacement. We present our current     technique and the pitfalls encountered when performing pulmonary valve replacement in adults.   "
193949|NCT00384176|"     The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in     treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab)     in combination with FOLFOX.   "
193950|NCT00384189|"     The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three     different dose levels compared with placebo with respect to pulmonary function, asthma     symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment     medication will be administered as follows: ciclesonide or placebo will be inhaled once daily     in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period     (12 weeks). The study provides further data on safety and tolerability of ciclesonide.   "
193951|NCT00384202|"     Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based     immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg)     basis from a Prograf® based immunosuppressive regimen.   "
193952|NCT00384215|"     This trial will explore the various advantages and possible disadvantages of pioglitazone and     insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid     profiles, quality of life and cost will be studied given a comprehensive set of data that may     help future treatment decisions.   "
193953|NCT00384228|"     This study will investigate if nilotinib provides an improved safety and efficacy profile     over that seen in patients receiving Imatinib.   "
193954|NCT00384241|"     High blood pressure affects nearly one third of all individuals in the United States. If left     untreated, it can lead to stroke, heart failure, heart attack, kidney failure, or blindness.     For many people, the exact cause of high blood pressure is unknown, but it is believed that     both genetic and environmental factors contribute to the development of the condition. The     purpose of this study is to examine the importance of genetics, inflammation, and stress on     the development of high blood pressure.   "
193955|NCT00384254|"     The purpose of the study is to compare two methods for providing brief dental office-based     interventions designed to help patients quit either cigarette smoking or smokeless tobacco     use, and to compare these two dental office-based interventions with usual care. This trial     will evaluate the effectiveness of a unique combination of dental office intervention plus     referral to the telephone help line, both of which have been demonstrated to be effective     interventions for tobacco cessation. The integration of two lines of research—dental office     interventions and telephone help line effectiveness—led us to propose this clinical trial as     a more efficient and disseminable model of both training and practice.   "
193956|NCT00384267|"     This study will look at blood samples taken from 300 preterm babies and newborns admitted for     inpatient care at Hopital Gabriel Toure in Bamako, Mali, and to gather information that will     help the investigators verify the role of malaria in illness of very small babies. Blood     samples will be taken from the mothers so that the investigators can find out if they have a     malaria infection and how their body fights malaria. The investigators will also determine     whether the mother and newborn baby are infected with the same malaria parasite. The     information from this study may be used to improve malaria treatment in very small babies.     Mothers and babies whose blood is tested will receive treatment for malaria as recommended by     the National Malaria Control Program (NCMP).   "
193957|NCT00384280|"     An open label, 2-period, sequential study to determine the impact of multiple doses of     rifampin on single-dose pharmacokinetics of HCV-796   "
193958|NCT00384293|"     This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia     on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess     the affects of MK0524A on carotid intima media thickening using ultrasound compared to     patients taking placebo. There will be 12 scheduled clinic visits involving review of medical     history, physical exam, vital signs, laboratory testing, ultrasound imaging, and     electrocardiograms.   "
193959|NCT00384306|"     The aim of this study is to establish associations between blood and urine markers of bone     metabolism with histomorphometric changes (changes in the actual bone structure) resulting     from short term oral prednisolone treatment in patients with COPD (chronic obstructive     pulmonary disease).   "
193960|NCT00384319|"     The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System     is able to quickly and conveniently cool patients who are comatose after resuscitation from     cardiac arrest.   "
193961|NCT00384332|"     This is an 8 week study that compares two medications. One medication is olanzapine (5-20 mg     daily) whereas the other medication is an orally disintegrating medication. Both medications     are used to treat depressed bipolar patients. The main focus of this study is the comparison     of these two medications on gastro-intestinal hormones and weight gain.   "
193962|NCT00384345|"     Bright light therapy has been used to safely and effectively treat conditions such as     Seasonal Affective Disorder and to regularize sleep in patients with circadian rhythm     disorder. Based on evidence of the link between bright light, serotonin, mood and     carbohydrate metabolism, it has been suggested that bright light therapy can improve weight     loss but the literature on the subject is sparse. Further, the literature suggests that apart     from any changes in mood and carbohydrate metabolism, bright light may reduce the unpleasant     side-effects of exercise and increase compliance to an exercise program.   "
193963|NCT00384358|"     The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as     an adjuvant to internal fixation in subjects with fractures of the proximal femur.   "
193964|NCT00384371|"     This study will test the hypothesis that Botulinum toxin A (BOTOX®) treatment reduces pain     and disability in subjects suffering from sub-acute low back pain due to an identifiable     muscle strain or back trauma occurring 6 to 16 weeks prior to enrollment. The study will also     delineate the duration of medication effect and control for any placebo or mechanical     trigger-point injection effect by employing a prospective, double-blind, placebo-controlled     design.   "
193965|NCT00384384|"     Background: 18B Glycyrrhetinic acid (active compound of Licorice) decreases serum potassium     via enhanced renal potassium loss in healthy individuals and thereby inducing renal sodium     retention and arterial hypertension.In dialysis patients this mechanism is disturbed and     compensatory intestinal potassium secretion is enhanced. 18B Glycyrrhetinic acid is an     inhibitor of 11B Hydroxysteroid dehydrogenase type 1 (11b HSD1). Inhibition of 11 b HSD1     offers a novel potential therapy to lower intracellular cortisol concentrations and thereby     enhance insulin sensitivity.      Hypothesis: Glycyrrhetinic acid decreases serum potassium by enhanced intestinal excretion in     dialysis patients and increases insulin sensivity by inhibition of 11b HSD      Methods: double blind, 6 month cross over trial comparing oral 18b Glycyrrhetinic acid with     placebo in 24 nondiabetic dialysis patients.      Endpoints: predialytic serum potassium levels, insuline sensitivity assessed by fasting     glucose and fasting insulin concentrations   "
193966|NCT00384397|"     This is a Phase III, modified single-blind, randomized, parallel-group, multicenter,     comparative trial in the United States designed to evaluate the immunogenicity and safety of     two doses of Menactra vaccine administered alone, and concomitantly with other routine     pediatric vaccines typically administered between 12 and 15 months of age.      Primary Objective:      To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.      Secondary Objectives:      Immunogenicity        -  To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when          Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines.        -  To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when          Menactra vaccine is administered alone or concomitantly with PCV vaccine.      Safety      - To describe the safety profile within 7 and 30 days of each vaccination, and serious     adverse events (SAEs) throughout the course of the study.   "
193967|NCT00384410|"     Sleep disturbance is perhaps one of the most prevalent complaints of patients with     long-standing painful conditions. Nabilone is a medication that is approved by Health Canada     as an anti-emetic (prevent vomiting) for patients undergoing chemotherapy. Nabilone, due to     its sleep promoting properties, is sometimes prescribed by physicians to pain patients to     help improve their sleep. However, there is no direct research evidence to either support or     refute this practice. This study will investigate if nabilone is effective in improving sleep     in insomnia and pain patients.   "
193968|NCT00384423|"     This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics     of PRX-03140 administered orally once daily for 14 days in subjects with mild Alzheimer's     Disease who are using a stable, well-tolerated 10 mg dose of Aricept (donepezil) but continue     to experience worsening AD symptoms.   "
193969|NCT00384436|"     The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active     comparator in severely depressed patients   "
193970|NCT00384449|"     The primary objective of this protocol is to look at whether Lucentis (ranibizumab) is safe     and effective when used for macular edema (retinal swelling) due to Eales' disease. The     secondary objective is to see if macular edema comes back within three months after the last     dose of study drug is given.   "
193971|NCT00384462|"     The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization     rates and to begin to address the utilization of outpatient resources for RSV     medically-attended lower respiratory tract infections (MALRI) in 32-35 week gestational age     (GA) premature infants who are less than 6 months of age and do not receive treatment.   "
193972|NCT00384475|"     The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal     spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of     seasonal allergic rhinitis caused by pollen. Ciclesonide will be administered once during the     exposure to ragweed pollen in a controlled environment. The study duration consists of a     baseline period (up to 5 days) and a treatment period (1 day). The study will provide further     data on safety and tolerability of ciclesonide.   "
193973|NCT00384488|"     The objective for this pilot project is to determine the feasibility and effectiveness of the     Interactive Voice Response protocol (IVR) on physical activity and eating behaviors in a     group men and women who have been identified by their physician as being pre-diabetic. We     hypothesize that participants receiving the IVR follow-up will have greater positive changes     in their physical activity and eating behaviors when compared to those who receive only the     standard-care pre-diabetes class.   "
193974|NCT00384501|"     Purpose To evaluate long-term follow up of Intacs microthin prescription inserts (Addition     Technology Inc, Fremont, Calif) for the management of keratoconus.      Design A long-term (five years) retrospective, follow-up study   "
193975|NCT00384514|"     Study title:A Study for Testing Safety and Efficacy of the administration of Blood-Borne     Autologous Endothelial Progenitor Cells to Alleviate Anginal Symptoms and Myocardial Ischemia     in Patients with Severe Anginal Syndrome      Principle Investigator: Assoc. Prof. Damras,Tresukosol,M.D.,Head of Cardiac Catherlization     unit,Division of Cardiology,Department of Medicine,Faculty of Medicine Siriraj     Hospital,Mahidol University      Study objective : To determine the safety and efficacy of intracoronary injection of     blood-borne autologous EPCs in relieving symptoms of angina pectoris in symptomatic patients     treated with maximal medical therapy with an occluded coronary artery supplying ischemic     myocardium Study Design : Phase II, a single center,a non-randomized,open-label trial,      Study population :      Total expected no. of patients : 24      main selection criteria :        -  Patients with chronic stable angina on maximal medical therapy and an occluded coronary          artery supplying an ischemic viable myocardial region as shown on Sesta-mibi scan. On          coronary angiography,the occluded coronary artery must have a patent proximal segment of          at least 30 mm with at least one side branch to enable the injection of the EPC if the          vessel remains occluded despite the attempted angioplasty efforts.        -  Age 18-80 years        -  Ejection fraction >35 % on Sesta-mibi scan        -  Sestamibi scan (myocardial perfusion) during exercise or dipyridamole,demonstrating          regional reversible ischemia in an area relating to the occluded coronary artery.      Investigational Product : At D-8 250 ml of blood drawn from the patients for production of     autologous EPCs or ACPs (VescellTM), On D0 ,at least 1.5 million EPCs with viability >75 %     suspended in 6 ml sterile cell culture medium will be injected to the same patients by     intracoronary artery.      The study consists of 4 periods:Screening ( D-14to-9&D-8,Treatment(D0),Acute Safety follow-up     (D1&D2),Chronic follow-up (D30,D90&D180)period ,total follow-up of each case is 6 months.      Evaluation criteria :      Safety : no.& duration of adverse event & serious adverse event      Efficacy :        -  change from baseline to 1,3,6 months of CCS, 6-minute walking test        -  change from baseline to 3 & 6 months of Sesta-mibi scan        -  change from baseline to 3 & 6 months of symptom-limited exercise time,exercise-induced          ischemia & METs on Sesta-mibi scan Duration of study: July 2004-December 2006   "
193976|NCT00384527|"     The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared     to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).   "
193977|NCT00384540|"     Primary purpose :To early detect cardiac allograft vasculopathy and to identify patients with     high risk of cardiac events, by coupling the analysis of the kinetics of the brain     natriuretic peptide ( BNP) with that of the left ventricle (LV) during a dobutamine stress     echocardiography.      Hypothesis : Plasma BNP elevation and abnormalities of LV kinetic during the ESD, will be     associated with the presence of allograft vasculopathy and the arisen of cardiovascular     events.   "
193978|NCT00384553|"     This study investigates toxicity and efficacy of 2 x R-DHAP followed by High dose     chemotherapy R-TEC and autologous stem cell transplantation in patients with relapsed or     refractory aggressive Non- Hodgkins's Lymphoma.   "
193979|NCT00384566|"     This study looks at the effect of two drugs (carvedilol and metoprolol) which are used for     patients with CHF (chronic heart failure).      These agents are beta-blockers and, although effective in heart failure, may cause increases     in airways tone and thus limit air getting into the lower parts of the lungs. Carvedilol is     more active at blocking the receptor that opens up the airways and therefore theoretically     may be more likely to reduce airways tone than metoprolol, although this has never been     studied in patients with heart failure, and that is the purpose of the present study.      We are looking to enrol 45 patients with heart failure and mild obstruction to the flow of     air in their lungs. Patients will be randomised to either carvedilol or metoprolol (standard     doses). Following a minimum of 2 weeks of therapy of study medication the patient will     undergo a study day involving an assessment of their lung function, an assessment of their     heart failure, a living with heart failure questionnaire, blood tests and blood pressure     and heart rate readings.      Patients will then be crossed over to the alternate medication. Following 2 weeks on the     target dose the patient will undergo their second study day which will be the same as the     first.      The results obtained from each study day will be compared.   "
194052|NCT00385905|"     The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of     restenosis as well as the safety after the cessation of the 6-month anti-platelet drug     treatment.   "
193983|NCT00384618|"     The ATIC study is a randomised, double- blind, placebo-controlled trial in which the effects     of oxidative stress-lowering treatment on vascular function and structure are studied in     patients with chronic non-diabetic renal failure who are free from manifest arterial     occlusive disease. Participants in the trial were randomised to active treatment consisting     of add-on therapy with pravastatin, vitamin E and homocysteine-lowering therapy, or to     placebo. Subjects not using angiotensin converting enzyme inhibitors (ACE-inhibitors) or     angiotensin receptor blockers (ARBs) at inclusion were put on ACE-inhibitors for at least two     weeks before the baseline measurement and randomisation. Those who were on ARBs continued     their ARBs. We excluded individuals with diabetes mellitus (ADA criteria), active vasculitis,     nephrotic syndrome (>3gr/24hr urine protein), renal transplantation, fasting total     cholesterol > 7 mmol/L, cholesterol-lowering therapy within three months prior to inclusion     or known ischemic cardiac, cerebrovascular or peripheral arterial disease. Ninety-three     patients (out of 118 eligible patients) took part in the study and written informed consent     was obtained from all participants.   "
193984|NCT00384631|"     Several studies have confirmed high levels of vascular endothelial growth factor (VEGF) in     eyes with neovascular glaucoma (NVG). The role of VEGF inhibitors in regression of other     neovascular disorders such as wet-type age-related macular degeneration and diabetic macular     edema has been described. We aim to evaluate the effect of three intravitreal injections of     bevacizumab (Avastin) 2.5 mg versus a sham procedure for treatment of NVG. Outcome measures     include intraocular pressure and extent of iris neovascularization. Both study arms will     receive conventional treatment for NVG.   "
193985|NCT00384644|"     It is possible to measure skeletal muscle tissue oxygenation (StO2) using near infrared     spectroscopy(NIRS). It is performed non invasively. We want to compare usually used invasive     methods for assessing adequacy of flow to StO2 in critically ill. Aim is to faster and non     invasively estimate adequacy of flow to make therapeutic algorithms efficient.   "
193986|NCT00384657|"     Recently, growing body of evidence support the finding that anemia frequently occurs in     patients with chronic heart failure (CHF). Chronic kidney disease (CKD), as well, is highly     prevalent among heart failure patients, and both anemia and CKD are independently associated     with increased mortality. A vicious circle is established with CHF causing both chronic renal     insufficiency and anemia, and CKD further aggravating anemia which, in turn, worsens CHF and     so on. Treatment of the anemia breaks this circle and improves the quality of life, cardiac     and renal functions in patients with severe CHF.      Intravenous iron alone was proved to allow the maintenance of target hematocrit in one-third     of chronic renal failure predialysis patients.      Based on these considerations, intravenous iron for anemia in patients with CHF and moderate     CKD would represent a reasonable therapeutic approach.      The aim of the trial is to assess the efficiency of intravenous iron therapy in the     management of mild to moderate anemia associated with CHF NYHA III class and concomitant     moderate CKD.   "
193987|NCT00384670|"     To assess the safety, reactogenicity and immunogenicity of two doses of the dengue vaccine in     Flavi-virus antibody-naive children between 6 and 9 years of age.   "
193989|NCT00378495|"     Miltefosine will be administered to Brazilian patients with kala azar   "
193990|NCT00378508|"     This is a randomized placebo controlled study to test whether a single 14 course of treatment     with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss     of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration     since diagnosis.   "
193991|NCT00378521|"     The Purpose of this study is to determine the response to two different strengths of a     topical gel containing nitroglycerin in patients with Raynaud's disease.   "
193992|NCT00378534|"     Bone marrow stem cell transplants (otherwise called bone marrow transplants) from healthy     donors are sometimes the only means of curing hematological malignant diseases such as acute     and chronic leukemias, myelodysplastic syndrome, myeloproliferative diseases and lymphomas.     Before transplant the patient receives chemotherapy and radiation treatment to reduce the     malignancy to low levels and to prevent rejection of the transplant. The transplant restores     the blood counts to normal and replaces the patients immunity with that of the donor. The     donor's immune cells increase the effect of the transplant by attacking remaining malignant     cells. Donor immune cells (especially those called T lymphocytes) also attack healthy     non-cancerous cells and tissues of the recipient causing graft-versus-host-disease (GVHD).     Strong GVHD reactions occurring within weeks after the transplant can be life-threatening .     In this study we remove most of the T lymphocytes from the transplant to minimize the risk of     GVHD. However to improve immunity against residual malignant cells and boost immunity to     infections, donor T cells (stored frozen at time of transplant) are given back around 90 days     after the transplant when they have a reduced risk of causing serious GVHD.      Any patient between 10 and 75 years of age with acute or chronic leukemia, myelodysplastic     syndrome, myeloproliferative syndromes or lymphoma, who have a family member who is a     suitable stem cell donor may be eligible for this study. Candidates are screened with a     medical history and various tests and examinations.   "
193993|NCT00378547|"     Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most     widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative     period, and another often used analgetic, morphine, causes nausea and vomiting. The     researchers therefore will investigate new combinations of postoperative analgesics in hopes     of improving pain and the need for opioids during the postoperative period.   "
193994|NCT00378560|"     A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult     women   "
193995|NCT00378573|"     This is a Phase II prospective, multicenter study evaluating Progression Free Survival (PFS)     after first line treatment with the combination of gemcitabine, docetaxel, and bevacizumab in     subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). PFS will be measured     from the date of registration (ie, assignment of subject number when subject meets all entry     criteria) to the earliest date of documented evidence of progressive disease, or the date of     death due to any cause, whichever occurs first.   "
194053|NCT00385918|"     This proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is     feasible in people with motor incomplete spinal cord injury, and three months of training     will improve cardiovascular fitness and gait functionality when compared to physical therapy     controls   "
193996|NCT00378586|"     Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of     oxygen. This leads to increased formation of different inflammatory and infectious markers.      The investigators hypothesize, therefore, that there is a significant difference in the     concentrations of inflammatory and infectious markers in the rectal mucosa between patients     with septic shock and healthy controls.   "
193997|NCT00378599|"     This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of     pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine     the sustained virologic response (SVR) at 24-week follow-up to 48 week in subjects after     orthotopic liver transplantation (OLT) with chronic hepatitis C (HCV) recurrence.   "
193998|NCT00384683|"     The goal of this clinical research study is to learn whether the inability of certain blood     vessel cells (endothelial cells) to function properly may help researchers to predict who is     at risk for complications after surgery and whether this dysfunction contributes to     complications after surgery. This study will use a blood test to quantify the number of cells     that are destined to become endothelial cells.   "
193999|NCT00384696|"     The goal of this behavioral research study is to put together and study a treatment for     nicotine dependence that looks at how participant's thoughts and feelings about smoking may     be related to how successfully they quit smoking.   "
194000|NCT00384709|"     Nursing home patients admitted to the hospital pose a significant challenge for health care     providers. Geriatric teaching pays particular attention to these admissions and related     problems. However, it is yet to be proven, whether geriatric training helps to overcome any     of these issues in a better way than through non-geriatric education. The study aims to prove     that geriatric training provides advantages over non-geriatric training in caring for nursing     home patients admitted to the hospital.   "
194001|NCT00384722|"     The primary objective of this clinical investigation is to evaluate the safety and     effectiveness of the EASYTRAK 3 Downsize Lead.   "
194002|NCT00384735|"     The purpose of this study is to evaluate the impact on overall survival of an intensive     follow-up protocol (as practiced today at TMH) against a more cost effective follow-up     protocol in patients operated for extremity sarcoma.   "
194003|NCT00384748|"     The purpose of the proposed study is to examine a Tele-rehabilitation (TR) intervention that     uses tele-health technology to improve outcomes of stroke patients after discharge to home.     The primary aim is to determine the effect of TR on physical function, and secondarily to     determine the effect on disability, falls-related self-efficacy, and patient satisfaction.   "
194004|NCT00384761|"     To establish normal values by age, race, and gender of novel markers of risk in healthy     subjects necessary to predict precise risk of cardiovascular disease in an individual   "
194005|NCT00384774|"     This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment     of migraine headache in order to select a dose range for further studies.   "
194006|NCT00384787|"     The purpose of this study is to determine the safety of, immune response to, and tolerability     of an adenoviral vector HIV vaccine given after a three-dose regimen of a DNA HIV vaccine.     The adenoviral vaccine will be given into arm muscle (intramuscularly), between skin layers     (intradermally), or under the skin (subcutaneously).      NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were     discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued.     Participants will be followed for safety and immune responses at regular study visits.   "
194007|NCT00384800|"     Primary objective:      To evaluate the overall response rate of tegafur/uracil (UFUR®) and thalidomide in the     treatment of advanced or metastatic hepatocellular carcinoma.      Secondary objectives:        1. To determine the disease stabilization rate;        2. To assess the progression-free survival and overall survival;        3. To establish the safety profile;        4. To evaluate the changes of circulating factors indicating the angiogenesis activity and          their correlation with objective tumor response.   "
194008|NCT00384813|"     Stress and anxiety can negatively affect children with asthma. Reducing the stress of     asthmatic children and their families may lead to improved asthma care and fewer asthma     symptoms in the children. The purpose of this study is to develop and evaluate a     family-focused asthma education program aimed at reducing stress levels and improving asthma     care for urban children with asthma.   "
194009|NCT00384826|"     To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control     rate after 4 months treatment of an early therapeutic permutation with the first month in the     absence of stabilization or objective answer.   "
194010|NCT00384839|"     The purpose of this research study is to find out what effects (good and bad) Vidaza has on     patients with prostate cancer. This investigational drug is not approved by the Food and Drug     Administration (FDA) for the treatment of prostate cancer; however, it is approved in     myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in this     study, Pharmion Corporation, is the manufacturer of Vidaza.   "
194011|NCT00384852|"     The primary objective of this study is to assess whether fracture union is accelerated in     subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy     (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard     of care alone.   "
194012|NCT00384865|"     The purpose of this study is to determine whether aspirin and simvastatin are safe and     effective for the treatment of pulmonary arterial hypertension (PAH).   "
194030|NCT00385593|"     This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a     more general setting in order to assess the real-life impact of introducing this new     treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a     conventional stepwise treatment regimen according to the investigator's judgement in patients     who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and     are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).   "
194031|NCT00385606|"     The purpose of this study is to evaluate the tolerability and efficacy of the addition of     rofecoxib to first-line chemotherapy, and to evaluate the efficacy of prolonged continuous     infusion of gemcitabine in combination with cisplatin in the treatment of patients affected     by advanced non-small cell lung cancer.   "
194013|NCT00384878|"     The primary end point of the study is confirmed objective response rate (complete response     [CR] and partial response [PR]). A response rate of 80 percent for cetuximab plus cisplatin     and weekly 24-hour infusion of high-dose 5-fluorouracil and leucovorin (P-HDFL) chemotherapy     is assumed. The Simon two-stage design will be used for P1 - P0 = 0.20. The response rates of     interest are P0 = 60% and P1 = 80%. The investigators will reject cetuximab plus P-HDFL     chemotherapy if the response rate is 8/13 at the first stage, and will reject the cetuximab     plus P-HDFL chemotherapy if the response rate is 25/35 at the second stage. If there are more     than 8 responses in 13 patients in the first stage, the study will continue to a total of 35     patients in the second stage. If there are more than 25 responses in 35 patients in the     second stage, this treatment will be acceptable with a p-value of 0.05 and of 0.20. Evaluable     patients for response will be those who received at least 4 doses of cetuximab (i.e. one     cycle of protocol treatment). All enrolled patients will be subjected to toxicity     evaluations.      The primary end point of the study is confirmed objective response rates (by RECIST, Response     Evaluation Criteria in Solid Tumors). The secondary end points of the study are     progression-free survival, overall survival, and treatment-related toxicities.      The analysis of response to treatment will be restricted to the eligible patients with at     least one measurable lesion. The safety analysis will be restricted to the patients who     received at least one cycle of the administered chemotherapy. The time-to-event end points     will be estimated using the method of Kaplan and Meier and based on the intent-to-treat     principle. Overall survival will be defined as the time interval between the date of study     entry and the date of death. Progression-free survival will be defined as the time interval     between the date of study entry and the date of disease progression or death, whichever     occurred first. Duration of response will be defined as the time interval between the date of     initial objective response and the date of disease progression, which is only for responders.     If the event is not yet observed at the time of the last record, the patient will be censored     at that time point.   "
194014|NCT00384891|"     The study is designed to compare the efficacy and safety of 2 treatment types for the     prevention of tumor recurrence of superficial bladder cancer:        1. A combination of bladder wall heating and local chemotherapy (Synergo)        2. Bacillus Calmette-Guérin (BCG)   "
194015|NCT00384904|"     The purpose of this clinical research study is to assess the effect of Famotidine given twice     daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.   "
194016|NCT00384917|"     An open label, 2-period, sequential study to determine the impact of multiple doses of     ketoconazole on single-dose pharmacokinetics of HCV-796   "
194017|NCT00384930|"     This is a randomized, double-blind, placebo-controlled, parallel-design, multinational,     12-week study to compare the efficacy, dose response, and safety of tadalafil once a day     versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including     lower urinary tract symptoms.   "
194018|NCT00384943|"     The purpose of this study is to evaluate the effectiveness of an aerobic home-based exercise     program for the treatment of postpartum depression.   "
194019|NCT00384956|"     The primary endpoint of this study is to estimate morphologic complete remission rate.     Estimation of response rate is also a secondary objection.   "
194020|NCT00384969|"     The objective of the phase I part of the study is to determine the maximum tolerated dose and     dose limiting toxicities of the combination of RAD001 and sorafenib in patients with     untreated metastatic kidney cancer.   "
194021|NCT00384982|"     The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a     multicenter, prospective, randomized, single-blind clinical trial designed to compare the     early and late intracoronary or combined (percutaneous intramyocardial and intracoronary)     administration of bone marrow-derived stem cells to patients after acute myocardial     infarction with reopened infarct-related artery.   "
194022|NCT00384995|"     Slowing of kidney function occurs in a minority of people given dye during angiography. The     purpose of this study is to compare two different types of fluid given into a vein to reduce     the risk of kidney injury: salt in water or baking soda in water.   "
194023|NCT00385008|"     An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and     naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.   "
194024|NCT00385515|"     Oral mucositis (OM) is a common and debilitating toxicity induced by many chemotherapy (CT)     regimens and by radiation to the head and neck. The purpose of this study is to determine the     effectiveness of SNX-1012 in decreasing the duration of Grade 2, 3, or 4 oral mucositis (OM)     according to World Health Organization (WHO) criteria.   "
194025|NCT00385528|"     Background: somatic patients with psychiatric co-morbidities are a major challenge for the     health care system. This study evaluated a psychiatric intervention targeted at the complex     medically ill identified by means of the INTERMED, an instrument to assess case complexity.      Methods: of 885 rheumatology inpatients and diabetes outpatients who were assessed for     eligibility, 247 were identified as complex (INTERMED score > 20) and randomized to the     intervention (N=125, 84 rheumatology and 41 diabetes patients) or care as usual (N=122, 78     rheumatology and 44 diabetes patients). Intervention consisted of counseling by a psychiatric     nurse, referral to a liaison psychiatrist, or a multidisciplinary case conference. Baseline     and follow up at months 3, 6, 9 and 12 measured prevalence of major depression (MINI),     depressive symptoms (CES-D), physical and mental health (SF-36), quality of life (EuroQol),     hospitalizations (rheumatology patients) and HbA1c levels (diabetic patients).   "
194026|NCT00385541|"     Both morphine and hydromorphone are pain medications commonly used after surgery. It is     thought at our institution that hydromorphone causes less side effects but this has not been     studied. We propose to treat our patients with either morphine or hydromorphone and determine     how much nausea, vomiting, and itching they have with each drug   "
194027|NCT00385554|"     This study will test the safety, side effects, and acceptability of two strengths of UC-781     gel when used by women and men in Botswana for two weeks.   "
194028|NCT00385567|"     HRG2 is a Phase 2 randomized, controlled, open-label, multi-dose trial to determine the     efficacy, safety, immunogenicity, and pharmacokinetic profile of PEHRG214 in HIV-infected     patients, treated three times weekly for up to 16 weeks.      All patients are receiving optimized standard of care HAART.      The primary objective of the study is to determine the effect of PEHRG214 in decreasing the     viral load (>=1.0 log10), as compared to a Control group. The primary hypothesis is that     treatment with PEHRG214 will result in clinically meaningful and sustained viral load     suppression.      The total sample size is 70-74 patients from approximately 8-10 participating study centers.     The first 16-20 patients are enrolled in the non-randomized pilot arm and 54 subsequent     patients are randomized (2:1 within center) to Treatment or Control group. The total study     duration is 7-12 months.   "
194029|NCT00385580|"     The purpose of this study is to learn if men with metastatic prostate cancer and rising     Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing     androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to     dasatinib. The safety of this treatment will also be studied.   "
194032|NCT00385632|"     The purpose of this study is to compare the effects of two different anti-HIV drug regimens     on quality of life and health care utilization among SMART study participants.   "
194036|NCT00385684|"     The purpose of this study was to determine whether a low dose an opiate pain medication is     effective for the treatment of discomfort in patients with advanced dementia. The study     medication was also known as Lortab and contained both a narcotic pain medication and     acetaminophen (the same pain medication as contained in Tylenol). This study was an     eight-week long clinical trial for discomfort among veterans with advanced dementia who were     admitted to a Nursing Home Care Unit (NHCU) at the Tuscaloosa VA Medical Center.   "
194037|NCT00385697|"     The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of     MGA031 when administered according to 3 different MGA031 dosing regimens in children and     adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All     regimens will be administered as an addition to insulin and other standard of care     treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce     typical insulin requirements while maintaining relatively normal blood sugar levels.      Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized     monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics,     Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.   "
194038|NCT00385710|"     Progressive Supranuclear Palsy (PSP) is a relentlessly progressive neurodegenerative     disorder, clinically characterized by parkinsonism with prominent axial involvement and     postural instability, bulbar symptoms, supranuclear ophthalmoplegia, and executive     dysfunction. Abnormal neuronal and glial tau aggregations affecting the basal ganglia and     selective brainstem structures result in dysfunction of the five frontosubcortical circuits     and brainstem functions. There is no effective treatment for PSP. One of the key feature in     the aggregation of tau is its phosphorylation by kinases such as glycogen synthase kinase 3b     (GSK3b). Recent reports have shown that valproic acid was able to inhibit the activity of     GSK3b and could exert a neuroprotective effect through this inhibition. The investigators     thus decided to conduct this controlled study to assess the putative neuroprotective effects     in patients with PSP.   "
194039|NCT00385723|"     This study is designed to examine the effects of fish oil on immune function and mood.   "
194040|NCT00385736|"     The objective of this study is to assess the efficacy and safety of adalimumab for the     induction of clinical remission in subjects with moderately to severely active ulcerative     colitis.   "
194041|NCT00385749|"     This study will compare single coil right ventricular defibrillation leads for implanted     cardioverter/defibrillators (ICDs) in the apical and high septal locations. It is     hypothesized that RV septal positions are at least as good as apical positions using formally     measured defibrillation thresholds(DFTs), and that they may have long term advantages in     reducing left ventricular dysfunction.   "
194042|NCT00385762|"     According to the National Institute of Mental Health, depressive disorders afflict over six     million U.S. men annually. Most cases of moderate or severe depression are treated with     antidepressants, including monoamine oxidase inhibitors, tricyclic antidepressants, and, more     recently, selective serotonin reuptake inhibitors (SSRIs) and antidepressants with modest     serotonin and norepinephrine reuptake inhibition but unknown mechanism-of-action. Over the     past two years, prescribing data show a steady increase in antidepressant dispensing rates     (especially including serotonin reuptake inhibitors) for adults. SSRIs are known to have an     effect on ejaculatory function and are therapeutically used for treatment of premature     (rapid) ejaculation. However, few studies have evaluated the potential impact of     antidepressant medications on male fertility, and no studies have been published with respect     to the impact of newer antidepressants, such as SSRIs, on male fertility. In the high-volume     male infertility practice at New York Hospital-Cornell Medical Center, several patients have     presented who have had a clear temporal association between SSRI use and impairment in sperm     motility and/or sperm transport (emission). These men have shown improvement in sperm counts     and motility after discontinuation of antidepressant medications.   "
194043|NCT00385775|"     This study is designed to find the maximum tolerated dose, safety and toxicity profile, and     to identify any dose limiting toxicities of AEG35156 administered in 2-hour infusions to     patients with advanced cancers.   "
194044|NCT00385788|"     The goal of this clinical research study is to learn if fludarabine, melphalan and     gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune     cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or     a mismatched related donor, can help to control Hodgkin's disease. The safety of the     treatment will also be studied.   "
194045|NCT00385801|"     The purpose of this study is to examine the effects of the administration of     Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI),     behavioral tests and measuring cocaine craving and use among people with active cocaine     dependence.   "
194046|NCT00385827|"     The purpose of this study is to assess the safety and efficacy of siltuximab administered in     combination with mitoxantrone and prednisone in participants with metastatic (spread of     cancer cells from one part of the body to another) hormone-refractory (not responding to     treatment) prostate cancer (abnormal tissue that grows and spreads in the body) (HRPC).   "
194047|NCT00385840|"     The purpose of this study is to evaluate the immunogenicity and the safety of a second     vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in     elderly aged 60 years and above   "
194048|NCT00385853|"     PTK is an investigational new drug that has been shown in early laboratory studies to prevent     the formation of new blood vessels that allow the tumor to grow. These studies have shown     that the study drug can potentially improve the effectiveness of additional radiation and     chemotherapy. With this study, we would like to examine the effects of PTK when used in     combination with radiation therapy and the anti-cancer drug temozolomide, the standard     treatment for patients with newly diagnosed glioblastoma. We would also like to learn how the     study drug is absorbed, distributed, and cleared from the body.   "
194049|NCT00385866|"     To reduce Cancer health care disparities that exists among minority Medicare beneficiaries     and to demonstrate cost effectiveness of patient navigation in reducing the burden of cancer.   "
194050|NCT00385879|"     The purpose of this study is to evaluate whether or not case management by a social worker     and nurse can decrease the number of emergency room visits, increase the number of primary     care doctor visits, and increase quality of life of people in a Medicaid managed care plan.   "
194055|NCT00385944|"     This is a multicenter, randomized, double-blind, cross-over study to compare the     pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg     maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel,     following a 900-mg loading dose (LD) of clopidogrel.   "
194056|NCT00385957|"     The study analyzes the virological response in plasma and non-plasma compartments, as well as     the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 <     100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease     inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).   "
194057|NCT00385970|"     To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV)     administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with     pTNM stage IIB or III colorectal cancer as subjects in a multicenter collaborative randomized     open-label comparative controlled study and consequently to determine the usefulness of the     above regimens as adjuvant therapy after surgery.   "
194058|NCT00385983|"     Harmonic scalpel is a new surgical instrument. Its use has been recommended in patients     submitted to total thyroidectomy. Few randomized controlled trials has been published.     However they had small sample sizes, used intermediate outcomes and included different     surgical procedures.      Our objective is to asses the use of Harmonic scalpel in patients submitted to total     thyroidectomy using surgical complications, operative time, drainage volume, postoperative     pain, length of stay and costs as outcomes. Our hypothesis is that Harmonic scalpel decreases     operative time,drainage volume, postoperative pain, length of stay and costs without     increasing surgical complications   "
194059|NCT00385996|"     The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking     tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the     tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib)     . This type of CT scan will measure the tumor by volume and by standard measurement (length     and width). Both methods will be compared to find out whether standard measurement or     measurement by tumor volume is more accurate.   "
194060|NCT00386009|"     The purpose of this study is to evaluate the function of the bladder and urethra during     urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia     treated with either placebo or tadalafil.   "
194061|NCT00386022|"     The purpose of this study is to study the effects of aging and estrogen on the brain.     Specifically, this study will examine how the hypothalamus signals the pituitary gland to     secrete reproductive hormones and how that changes with aging.   "
194062|NCT00386035|"     The purpose of this study is to compare the effects of two different anti-HIV drug regimens     on HIV transmission risk behavior among SMART study participants.   "
194063|NCT00386048|"     Sickle cell disease (SCD) is a devastating chronic health condition that primarily affects     African-Americans. Painful episodes are the most frequent form of morbidity in SCD and the     most frequent reason for hospitalization. Cognitive-behavioral interventions for pain     management have shown efficacy for improving coping abilities, reducing the amount of     medication needed to manage pain, and improving daily functioning during painful episodes.     However, difficulties with disseminating and implementing cognitive-behavioral treatments     have resulted in almost no use of these techniques in pediatric settings. In South Carolina     these difficulties are compounded by social and geographical factors that pose particular     challenges. A major issue with implementing quality pain management protocols is the     difficulty with providing adequate practice and monitoring of the use of the techniques,     particularly given the rural population in South Carolina and transportation difficulties for     economically disadvantaged families. Due to a history of under-treating pain in SCD it is     also critical that psychological and medical treatments are presented in an integrated manner     so that these approaches are viewed as complimentary, not mutually exclusive, approaches to     pain management. Finally, we believe the same implementation issues for improving the use of     behavioral coping skills are also important for improving adherence to medication protocols     for appropriate home-based pain management.      The purpose of this proposal is to develop, implement, and evaluate a pain management     protocol that uses portable electronic devices and other technologies to increase the     practice of psychosocial pain management techniques, improve adherence to the overall     biopsychosocial pain management protocol, and improve the clinician's ability to track     progress with fewer office visits. In addition to addressing important dissemination issues,     by embedding methods to assess for adherence into the technology it will be possible to     continuously evaluate and modify protocol efficacy, resulting in a product that is effective,     empirically sound, and flexible. Participants will be randomly assigned to the intervention     or waitlist control condition. Those on the waitlist condition will receive the same study     procedures after a 2 month wait periods. We anticipate that the intervention will result in     better pain management and less impairment in the participants.   "
194064|NCT00386061|"     The primary objective was to assess the effect of SR141716 on weight loss and weight     maintenance over a period of one year when prescribed with a hypocaloric diet in obese     patients with or without comorbidities.      The main secondary objectives were to assess the effect of SR141716 on lipid parameters     (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist     circumference, glycemic parameters.   "
194065|NCT00386074|"     The purpose of this study is to assess whether NaFeEDTA and electrolytic iron improve iron     status of young school children, when added as iron fortificants in whole maize flour.   "
194066|NCT00386087|"     The purpose of this study is to determine the effectiveness of enzastaurin in the treatment     of patients with metastatic breast cancer.   "
194067|NCT00386100|"     This study will evaluate the longer-term glycemic effect of two medicines approved for     initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2     study visits), followed by an 80 week double-blind treatment period (11 study visits). Also,     a sub-study was included to look at changes in bone mineral density (BMD) at the lumbar     spine.   "
194068|NCT00386113|"     Since influenza vaccines are normally administered every year because of the frequent change     in their antigenic composition, the safety and immunogenicity profile of adjuvanted influenza     vaccine need to be re-evaluated after repeated vaccine administration. In this study,     subjects previously vaccinated with Fluarix or the influenza adjuvanted vaccine, will receive     a booster dose with the 2006-2007 season's formulations of either Fluarix or the adjuvanted     vaccine.   "
194086|NCT00386360|"     The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral     Quantitative Computed Tomography) technology to detect minute changes in bone     microarchitecture.   "
194113|NCT00386724|"     The primary objective of this study is to evaluate the acute and chronic efficacy of spinal     cord stimulation using the Precision implantable neurostimulation device with the Artisan     paddle electrode in patients with Failed Back Surgery Syndrome (FBSS) and associated primary     or secondary back or lower extremity pain. There are significant numbers of patients with     FBSS who have moderate to severe drug refractory pain. An optimal outcome will demonstrate     that the Precision SCS device has significant effectiveness in reducing this pain resulting     in improved quality of life and functional capacity.   "
194069|NCT00386126|"     Anemia has been demonstrated to be a common finding in patients with heart failure (HF).     Previous studies in hospitalized patients with HF have found a prevalence of anemia ranging     from 15% to 63%. More importantly, anemic patients with HF have increased morbidity and     mortality. The mechanisms underlying anemia in HF are multifactorial, involving mild to     moderate forms of anemia of chronic disease and ferropenic anemia. The clinical impact of     iron supplementation in HF patients who have a relatively preserved renal function and either     chronic disease anemia, ferropenic anemia or both remains largely unknown. The route of iron     administration that could be most clinically effective is also unclear. Thus, the primary aim     of the IRON-HF study is to assess the effects of iron supplementation alone (IV or PO) on     parameters of functional capacity in HF patients with anemia with decreased availability of     iron.   "
194070|NCT00386139|"     Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and     HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure     response to aliskiren 300 mg.   "
194071|NCT00386152|"     The purpose of this study is to compare hemoglobin response rates between two PROCRIT     (epoetin alfa) doses and ARANESP (darbepoetin alfa) in anemic cancer patients receiving     chemotherapy   "
194072|NCT00386165|"     To demonstrate the safety and tolerance of single, oral doses of AT-1001 in celiac disease     subjects that are gluten-free diets and in remission.   "
194073|NCT00386178|"     Gamma tocopherol (gt) is a naturally occurring form of vitamin E that is found in many foods,     and is also commercially available as a vitamin supplement. The purpose of this Phase 1     research study is to see if two doses of gt, 600mg and 1200mg, are safe (do not cause     gastrointestinal distress or other problems), and can cause changes in your blood levels of     gt and other antioxidants. This study will also examine if there is a difference in response     between asthmatic and non-asthmatic adults when taking the same dose of gt. Phase 1 research     studies like this one are not intended to be a treatment, but are a scientific investigation.   "
194074|NCT00386191|"     The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral     infarction with respect to incidence of bleeding adverse events.   "
194075|NCT00386204|"     The purpose of this study is a comparison of efficacy and side effects of Q-switched Ruby     laser treatment for solar lentigines in two different skin types II and IV.   "
194076|NCT00386217|"     The success of cancer treatment combined with the trend to delay childbearing is increasing     the numbers of women survivors whose childbearing has been interrupted by cancer. For some,     treatment has resulted in infertility. Others have been advised to delay pregnancy until a     certain follow-up interval or have new fears that pregnancy could be a risk to maternal     health. Not least is the concern that children born after a mother's cancer would face     increased risks for birth defects or cancer.      The specific aims of this project are as follows:        1. To measure the impact of cancer-related interruption of childbearing on women's          long-term emotional well-being and health-related quality of life, over and above other          demographic and cancer-related factors        2. To find out if becoming a biological or social mother after cancer treatment decreases          the long-term psychosocial impact of interrupted childbearing compared to remaining          childless        3. To refine the psychometric properties of questionnaires for female cancer survivors          measuring Distress about Cancer-Related Childbearing Issues and Attitudes towards          Parenthood after Cancer        4. To define targets for a future intervention to improve female survivors' knowledge about          childbearing after cancer, decrease distress associated with interrupted childbearing,          and promote peer support.   "
194077|NCT00386230|"     The purpose of the study was to test the equivalence of a short zidovudine (ZDV) regimen as     compared to a longer, ACTG-076-like, ZDV regimen in reducing the risk of mother-to-child     transmission of HIV: and to assess and compare the safety and tolerance of the long and     shortened ZDV regimens.   "
194078|NCT00386243|"     The purpose of this study is to determine if a stepped-care intervention makes pain symptoms     better and reduces activity limitations because of pain. Our two primary hypotheses are that     in OIF/OEF veterans with chronic pain:        1. Stepped care is more effective than usual care in reducing pain-related disability        2. Stepped care is more effective than usual care in reducing psychological distress   "
194079|NCT00386256|"     The purpose of this study is to develop a home exercise program for patients 60 years of age     and over who are deconditioned following their discharge from the hospital, or recruited from     GLA outpatient clinics. The program will be designed to monitor and improve patients'     exercise behavior through the use of home technology, such as text messaging monitors.   "
194080|NCT00386269|"     This study examines the analgesic efficacy of codeine phosphate. It is compared to placebo in     infants receiving morphine after surgery. Codeine may be effective enough to make morphine     unnecessary.   "
194081|NCT00386282|"     This study examined the acceptability and feasibility of introducing a     mifepristone-misoprostol regimen of medical abortion into abortion services in two private     clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4     clinics in Mexico City. It was hypothesized that the study regimen would be both acceptable     and efficacious.   "
194082|NCT00386308|"     The purpose of this study is to determine whether XP12B is effective and safe in the     treatment of women with heavy menstrual bleeding associated with menorrhagia.   "
194083|NCT00386321|"     The purpose of this study is to determine whether the treatment of Yt90 Zevalin in     combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)are     effective as first line treatment in patients with bulky stage II or stage III or IV diffuse     large B-cell lymphoma   "
194084|NCT00386334|"     To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in     elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at     bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be     safe and well tolerated, improve subjective sleep measures, improve measures of Quality of     Life and next day insomnia symptoms, and have no significant withdrawal central nervous     system adverse events or rebound insomnia.   "
194085|NCT00386347|"     This study is a two-part study. Part one is designed to see how different formulations of     GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in     the body. Part two is designed to see how repeat dosing affects how GSK364735 is absorbed in     the body.   "
194087|NCT00386373|"     Primary Objective:      1. To assess the safety and toxicity of imatinib mesylate when given to patients with Ph (+)     CML , ALL or AML within the first 100 days following allogeneic bone marrow or stem cell     transplantation.      Secondary Objectives:        1. To identify any clinically significant drug interactions with imatinib in the          post-transplant setting.        2. To develop specific monitoring parameters for imatinib use when utilized in the early          post-BMT setting.        3. To record one-year survival data in this patient cohort to assess any effect of early          imatinib administration on this endpoint.   "
194088|NCT00386386|"     The study's overarching aim is to determine whether Enzymatically Augmented Subcutaneous     Infusion (EASI) can assist in out-of-hospital situations characterized by mismatch between     need for, and ability to achieve, access to the vascular compartment. One mechanism for     providing access to the vascular compartment, subcutaneous infusion, is facilitated by     administration of hyaluronidase; the hyaluronidase hydrolyzes hyaluronan the major     subcutaneous diffusion barrier. Hyaluronidase thus increases local dispersion and absorption     of subcutaneously administered drugs and fluids.      The EASI Access study is intended to be the first out-of-hospital study assessing     FDA-approved Chinese hamster ovary-derived recombinant hyaluronidase (the recombinant product     is hereafter referred to by the shorter brand name, Hylenex). The EASI Access will test some     fundamental principles and will facilitate design and implementation of follow-up     investigations (e.g. extension of access to non-ALS providers). For example, we will attempt     to show that EASI access is simple, effective, and has few or no downsides as compared to IV     access.   "
194089|NCT00386399|"     Patients will be tested for mutations in the BRCA2 gene. If they have a BRCA2 mutation, they     will be treated with Mitomycin-C as described here. The patients with an identified gene     mutation will also be provided with genetic counseling.   "
194090|NCT00386412|"     PRINCIPAL ENDPOINT To value valganciclovir efficacy in advance treatment of CMV in patients     received allogenic transplant with a uniform treatment.      SECONDARY ENDPOINT To value valganciclovir security in advance treatment of CMV in in     patients received allogenic transplant with a uniform treatment.      The security will be valued by the % of patients that:      Will have negative CMV Neutropenia <1000 neutrophils/mm3 or <500 neutrophils/mm3 in the first     35 days of treatment - follow-up Renal toxicity in the first 35 days of treatment - follow-up     (defined by elevated creatinine >1mg/dL or twice the basal value) CMV illness during the     treatment or in the next 2 months Blood Antigenemia / PCR positive in the next 2months of     treatment      This dates Hill be compared with a patients control group treated with intravenous     valganciclovir   "
194091|NCT00386425|"     In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin     alfa (activated) at the normal, approved dose and time of administration [24     microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will receive the normal, approved dose     or higher doses than the approved dose for a longer administration time. After the drug     administration is complete, the protein C levels from the patients receiving the normal,     approved dose will be compared to protein C levels from patients receiving the normal,     approved dose or higher dose for a longer duration to determine if the protein C levels     improve faster if given higher dose and/or longer administration time.      Note: The protocol was amended to remove the option of shorter infusion durations.   "
194092|NCT00386438|"     -Does Honan balloon reduce intraocular pressure preoperatively?   "
194093|NCT00386451|"     A prospective randomized study to compare 2 groups:        -  heparine lock with positive pressure        -  lock without a needle with positive pressure   "
194094|NCT00386464|"     Non-invasive ventilation or BiPAP®, which is a form of breathing support delivered through a     facemask, is a successful treatment for the respiratory complications of amyotrophic lateral     sclerosis (ALS). It has been shown to prolong survival, improve quality of life, and improve     cognitive function. It is widely used among patients with ALS who have advanced breathing     difficulties. It is not known whether there is benefit to using non-invasive ventilation     earlier in the disease course.      There is evidence that non-invasive ventilation may slow down the decline in breathing     function. If this were true then it would make sense to start non-invasive ventilation use     earlier than the current clinically accepted practices.      The purpose of this study is to determine whether using non-invasive ventilation early in the     course of disease can slow the decline in breathing function.      Patients remain in the study for 6 months and are asked to make 7 clinic visits during which     time they will undergo pulmonary function tests and complete questionnaires.   "
194095|NCT00386477|"     The objective of the project is to find out whether cleansing the vagina before a cesarean     delivery decreases the risk of complications and infections after having the baby. If this is     the case, cleansing the vagina before cesarean delivery can help improve outcomes for many     women and make their early postpartum recovery much more pleasant, giving a healthier start     for the family.   "
194096|NCT00386490|"     To demonstrate the safety and tolerance of multiple, oral doses of AT-1001   "
194097|NCT00386503|"     -  Primary Objective: to evaluate the interaction with food after a single oral dose of a          fixed combination of amodiaquine (AQ) and artesunate (AS) (COARSUCAM™) in healthy male          subjects        -  Secondary Objective: to assess the clinical and biological safety and tolerability of          Coarsucam™   "
194098|NCT00386516|"     The purpose of this clinical trial is to determine whether the combination of the established     chemotherapeutic agent 5-fluorouracil(5-FU) and the large carbohydrate molecule GM-CT-01 is     beneficial in treating advanced gall bladder and bile duct cancer.   "
194099|NCT00386529|"     The purpose of this study is to evaluate the influence of aspirin on blood pressure in     well-controlled hypertensive patients who receive low dose aspirin at different times of the     day   "
194110|NCT00386685|"     The primary objective of the study is to assess the activity of XRP9881 in combination with     trastuzumab.      The secondary objectives are safety and pharmacokinetic interaction   "
194111|NCT00386698|"     Since influenza vaccines are normally administered every year because of the frequent change     in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted     influenza vaccine need to be re-evaluated after repeated vaccine administration. In this     study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007     season's formulations of Fluarix or the adjuvanted vaccine.   "
194100|NCT00386542|"     This is a sequential phase I and II, controlled, double-blinded study to determine whether     immune responses suggesting protection against influenza can safely be induced in young     children by two reduced doses one month apart of 0.1 mL of a trivalent inactivated influenza     vaccine (INF) administered by the intradermal (ID) route with an investigational ID spacer on     a United States (U.S.)-licensed needle-free jet injector (JI), compared to two standard     intramuscular (IM) 0.25 mL doses by needle-syringe (N-S) in this age group. The locale is a     developing country where financial restraints for the use of full-dose influenza vaccine     would limit protection from an influenza pandemic threat, where N-Ss pose dangers and     drawbacks in clinical use, and where Mantoux-type N-S ID injections are difficult to     administer during mass campaigns.   "
194101|NCT00386555|"     To determine the effectiveness of CP-868,596 + docetaxel, AG-013736 + docetaxel and     CP-868,596 + AG-013736 + docetaxel in patients previously treated for non-small cell lung     cancer.   "
194102|NCT00386581|"     The study is designed to investigate the acute treatment efficacy, safety, and tolerability     of atomoxetine on a once-daily dosing strategy (in the morning). It incorporates a 6-week     acute treatment period and a 2-week discontinuation phase. The assessments in this study     include a standard assessment of ADHD symptomatology using a Diagnostic and Statistical     Manual of Mental Disorders, Fourth Edition™, investigator-administered rating scale.   "
194103|NCT00386594|"     Barrett's esophagus with high-grade dysplasia is a premalignant condition caused by chronic     reflux of gastric contents into the esophagus. High-grade dysplasia is the same as     carcinoma-in-situ. If untreated, patients with this condition are at high risk for developing     cancer of the esophagus. Cancer of the esophagus is a miserable disease that is difficult to     treat and about 95% fatal after 5 years. To prevent progession to cancer of the esophagus     several interventions are available and they include surgery, Photofrin photodynamic therapy,     endoscopic mucosal resection and endoscopic thermal therapy. All of these modalities are     uncomfortable, expensive and have associated risks. The oral agent, 852A stimulates the     innate immune system in such a way as to eliminate early cancer. A similar dermatologic     drug(imiquimod) is approved for treating the premalignant condition, actinic keratosis. If     local therapy with imiquimod can eliminate a premalignant lesion in the skin, a similar     acting drug should be able to do the same for a premalignant lesion in the lining of the     esophagus. This study is designed to test that hypothesis.   "
194104|NCT00386607|"     Assessment of the long-term safety and tolerability of the combination of aliskiren and     valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of     long-term safety and tolerability of the combination of     aliskiren/valsartan/Hydrochlorothiazide(HCTZ).   "
194105|NCT00386620|"     Ecological Momentary Assessment (EMA) refers to the collection of repeated measurements of     phenomena as they occur in naturalistic settings using hand-held computers. By providing an     EMA of psychosocial variables that influence patient pain and pain behaviors, this study     seeks to characterize the pain experience in metastatic breast cancer from both patients' and     spouses' perspectives.      This study consists of two parts. Part 1 involves developing and pilot testing a hand-held     computer program designed to assess antecedents, behaviors, and consequences of patient pain,     as well as spouse response to pain. Five couples will complete a baseline survey and carry     the hand-held computer for two weeks. They will be interviewed for feedback to refine the     program. Part 2 is a longitudinal assessment of the psychological and relationship     functioning of metastatic breast cancer patients and their spouses. The Optional Procedure     for Part 2 involves using electronic diaries (EDs) to measure the cancer pain experience for     patients with metastatic breast cancer and their spouses.      The specific aims of this study are to: (1) To examine patient pain, spouse response to     patient pain, and patient behaviors in response to pain over the course of 6 months in     couples facing metastatic breast cancer, (2) test the biopsychosocial model of chronic pain     in breast cancer; expanding it to include the influence of patient psychological functioning,     spouse psychological functioning, and relationship functioning, on patient pain, spouse     behaviors, and patient behaviors in response to pain, (3) use ecological momentary assessment     to characterize patient pain, spouse response to patient pain, and patient behaviors in     response to pain.   "
194106|NCT00386633|"     At the end of 2004 there were more than 40 million people infected worldwide with HIV, with     an estimated 16,000 new infections every day (Joint United Nations Programme on HIV/AIDS     [UNAIDS], 2004). The HIV epidemic threatens whole societies particularly in Africa and Asia     and rates of infections in the Western countries have also increased over the last few years.     However, despite more than 15 years of research, an effective vaccine against HIV and     acquired immunodeficiency syndrome (AIDS) has still not been developed.      There is considerable evidence that cellular immune responses can effectively control HIV-1     replication during acute and chronic infections thereby possibly protecting individuals from     infection and preventing the spread of HIV. To be truly effective in the general population,     a vaccine must induce responses specific to immunologically conserved regions. The     epitope-based vaccine MVA-mBN32 represents a very logical approach to this problem because of     its potential to elicit a polyfunctional immune response and to focus these responses to     conserved epitopes.      In this study the safety, tolerability, and immunogenicity of a recombinant MVA-BN® vaccine     expressing cytotoxic T lymphocyte (CTL) and helper T lymphocyte (HTL) epitopes of HIV-1     (MVA-mBN32) in 36 healthy volunteers will be examined. This will include a full analysis of     CD4+ T helper cells and CD8+ CTL responses to these epitopes, to establish the potential of     such a homologous prime-boost vaccine approach to induce a broad cell-mediated response to     different HIV antigens.   "
194107|NCT00386646|"     To compare if 0.5% carboxymethylcellulose with 0.005% SOC (Stabilized oxychloro complex) have     the same effectiveness and safety as 0.5% carboxymethylcellulose on dry eye patients.   "
194108|NCT00386659|"     Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological     response in plasma and extra-plasmatic compartments, together with the degree and kinetics of     immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when     treated with tenofovir and abacavir together with lopinavir or efavirenz.   "
194109|NCT00386672|"     The purpose of the study is to find out if taking calcium and vitamin D supplements, while     following a low-calorie diet, can help people lose weight.   "
194112|NCT00386711|"     improve detection and management of suicide risk among depressed patients in primary care   "
194114|NCT00386737|"     Annually, asthma is responsible for 1 million emergency room visits, 400,000     hospitalizations, and 5000 deaths according to the NHLBI. In addition, 10 million missed     school-days per year and 100 million days of restricted activity are attributed to this     disease. While there is no known cause or cure for asthma, recent studies have shown that     hospitalizations and emergency room visits can be reduced by as much as 78% and 73%,     respectively, when the disease is properly managed. According to the EPA, the occurance of     children with asthma more than doubled the rate of two decades ago; in 2001 the percentage of     asthmatic children was 8.7% (6.3 million children).      Properly managing asthma is nontrivial and can often require an asthma specialist. The     difficulty in diagnosing and managing asthma lies primarily in the lack of available clinical     technologies capable of assessing airway inflammation, an early and persistent component of     asthma. Accordingly, the National Institutes of Health (NIH) guidelines for the diagnosis and     management of asthma strongly recommend long term anti-inflammatory therapies, such as oral     or inhaled corticosteroids, to reverse airway inflammation in an effort to prevent     irreversible airway damage, termed “airway remodeling”. The medical community has expressed     the need for more objective and noninvasive measures of airway inflammation for diagnosing     asthma and monitoring the effectiveness and compliance of anti-inflammatory therapies.      The clinical research plan is designed to evaluate airway inflammation associated with     asthma. In this human subjects study, a non-invasive exhaled breath analysis sensor, called     the Breathmeter, will be used to measure eNO concentrations in children and adults (ages     4-65) with a broad range of respiratory disorders as well as those with no known respiratory     disorders. Breath donations will be simple and straightforward presenting little to no     discomfort to volunteers.   "
194115|NCT00386750|"     THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.      To evaluate the effects of artemether/ lumefantrine on the auditory function.   "
194116|NCT00386763|"     This study will evaluate the safety and efficacy of artemether-lumefantrine against     uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.   "
194117|NCT00386776|"     With this clinical study, we hoped to find out if interactive, computer-based medical     interviews, when carefully tested and honed and made available to patients in their homes on     the Internet, will improve both the efficiency and quality of medical care and be well     received and found helpful by patients and their physicians. We developed the computer-based     medical interview consisting of over 6000 questions and a corresponding program that provides     a concisely written, summary of the patient's responses to the questions in the interview. We     then conducted read aloud and test/retest reliability evaluations of the interview and     summary programs and determined the programs to be reliable. Results were published in the     November 27, 2010 issue of the Journal of the American medical Informatics Association. We     also developed, edited, and revised a program that provides a concisely written, summary of     the patient's responses to the questions in the interview.      We obtained a grant from the Rx Foundation to conduct clinical trial of our medical history.     At the time of the office visit, the summary of the computer-based history of those patients     who had completed the interview was available on the doctor's computer screen for the doctor     and patient to use together on a voluntary basis. The results of this trial were published in     the January 2012 issue of the Journal of the American Informatics Association.   "
194118|NCT00386789|"     Typhoid fever remains an important cause of morbidity and mortality in the developing world.     It is estimated that more than 16 million cases and about 600,000 deaths occur annually, most     of which occur in Southeast Asia and Africa. Ingestion of food or water contaminated by     acutely infected persons or chronic carriers is the most common form of transmission. As a     result, typhoid fever is prevalent where unsafe drinking water or contaminated food is     common.      Typhoid fever is highly endemic in Vietnam, especially in the southern provinces and is a     significant disease in both preschool and school-aged children. Data from Dong Thap     Provincial Hospital, Mekong delta region showed that among 3,934 hospitalized typhoid fever     cases from 1990 to 1995, 4.2% had complications and 0.8% died.      Typhoid fever has become difficult and expensive to treat. About 90% of Salmonella typhi     isolates are of multidrug-resistant (resistant to chloramphenicol, ampicillin, and     trimethoprim-sulfamethoxazole) and 76% of isolates showed reduced susceptibility to     fluoroquinolones. Isolates with full fluoroquinolone or extended spectrum cephalosporin     resistance have not yet reported in Vietnam but occur sporadically in the Indian     subcontinent. If they become widespread, alternative treatment options will be limited. The     improvement of sanitation, provision of safe water and elimination of chronic carriage is not     expected to be achieved quickly. Accordingly, vaccination against typhoid fever is     increasingly important national public health priority.   "
194119|NCT00386802|"     Primary purpose: Frequency of use of broad-spectrum antifungals in the episode of     neutropenia.      Secondary purposes:To determine the safety and toxicity measure by:        1. Frequency of Invader Fungal Infection.        2. Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole,          voriconazole, caspofungin, terbinafine, during the period of study.        3. Mortality        4. Development of nephrotoxicity        5. Use of galactomannan in this clinical context        6. Time of administration of empirical antifungal therapy of broad-spectrum.   "
194120|NCT00386815|"     To investigate safety of pemetrexed combined with cisplatin for chemo therapy-naive patients     with malignant pleural mesothelioma   "
194121|NCT00386828|"     This phase II study will evaluate the effect of bevacizumab, capecitabine and oxaliplatin     with radiation on rectal cancer. Researchers will also evaluate the tolerability (how it     makes the patient feel) and safety of this combination by watching for harmful     side-effects.It is hoped that by adding bevacizumab to the capecitabine/oxaliplatin treatment     in combination with radiation before surgery will improve response rate.   "
194122|NCT00386841|"     The purpose of this study is to determine whether outcome following antidepressant treatment     can be used as a tool to evaluate endo-phenotypes for depression.   "
194123|NCT00386854|"     The purpose of this study is to evaluate the metabolic and anti-inflammatory effects of     eccentric endurance exercise and to compare them with those of concentric exercise in healthy     sedentary individuals.   "
194124|NCT00386867|"     This open-label, randomized study will compare the efficacy, safety, and acceptability of     mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral     misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.   "
194125|NCT00386880|"     Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has     been noted in several studies that in patients with migraine, seventy nine percent of the     patients experienced allodynia on the facial skin on the same side as the headache.     Understanding more about the occurrence of phonophobia (increased sensitivity to sound) and     allodynia may help us understand how the pain system works in migraine. It is hoped that the     knowledge gained from this trial may enable us to more effectively treat patients with     migraine headache.   "
194126|NCT00386893|"     Aim of this study is to investigate neuronal differences (EEG/evoked potentials; functional     MRI) between patients with major depression and healthy controls concerning brain activity     after acute pain as well as changes of pain related brain activity during treatment with     escitalopram.   "
194127|NCT00386906|"     The goal of this clinical research study is to find the sentinel lymph node (SLN) (s) and     biopsy it (them) to see if the patient has small or low volume metastatic disease that would     otherwise have been missed.   "
194128|NCT00386919|"     Patients with high grade brain tumors will be treated to test shortened course of radiation     therapy with the use of precise, focused radiation with cyberknife.   "
194129|NCT00386945|"     The purpose of the study is to develop an office-based tobacco intervention for chiropractic     patients.   "
194130|NCT00386958|"     Bacterial corneal ulcers are a leading cause of pediatric blindness in underdeveloped     countries due to a lack of antibiotic availability and affordability, among other reasons.     Povidone-iodine, an inexpensive and readily available broad-spectrum antimicrobial agent, may     be an effective and affordable treatment for corneal ulcers, allowing preservation of sight     for those afflicted with this disease.   "
194131|NCT00386971|"     Included in this study will be patients with HIV and being treated with highly active     antiretroviral medications (HAART) including protease inhibitors (PI) or non-nucleoside     reverse transcriptase inhibitors (NNRTI). Protease inhibitors and non-nucleoside reverse     transcriptase inhibitors are very common medications in HIV treatment and are usually given     with other medications as part of a standard treatment for HIV (HAART).      We hope to learn more about how the levels of cholesterol-and triglyceride-carrying particles     (lipoproteins) are affected by a nutritional supplement, L-Carnitine, in HIV-positive     patients treated with antiretroviral medications.   "
194132|NCT00386984|"     A preliminary study has shown that the hormone-similar, growth-retarding drug octreotide can     prolong survival time in patients with primary liver cancer. Due to methodological     deficiencies of the preliminary study the results will be re-checked by the comparison of     octreotide with an pseudo-drug (so-called placebo) primarily regarding to the survival time     and secondarily concerning costs, side effects, patient cooperation and quality of life as     well as specific conditions in the tumor tissue in both groups with 108 patients with primary     liver cancer.   "
194133|NCT00386997|"     Due to the poor outcome of patients with invasive fungal infections (IFI), a more effective     prevention of these infections in such patients is wanted. These experiences in intensively     treated elderly patients with acute leukemia are especially worrying.      This pilot study is designed to collect information on the safety (and efficacy) of an     antifungal preventative therapy with an AmBisome® loading dose regimen of 7 mg/kg/week, in     four weekly administrations, during the aplastic phase following the start of chemotherapy     for acute lymphoblastic leukemia in elderly patients, which is a high risk period for severe     fungal infections.   "
194134|NCT00387010|"     The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal     tablets on the anxiety symptoms commonly associated with chronic pain in patients with     breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate     patient functioning, and to determine any influences on the successful dose achieved.   "
194135|NCT00387023|"     Primary Objectives:        1. To evaluate the efficacy of Zevalin for the treatment of low-grade follicular          Non-Hodgkin's lymphoma of the orbit or mucosa-associated lymphoid tissue (MALT) of          conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy          and external examination of the conjunctiva), and external photography whenever          possible.        2. To establish the safety profile in this patient population using clinical examination          including slit lamp biomicroscopy, and evaluation of the tear film with Schirmer's test.        3. To establish the dosimetry for Zevalin in the orbit in the first 3 patients who agree to          undergo dosimetry.   "
194136|NCT00387036|"     To test the effect of the research study drug, inhaled fluticasone on lung function in     exercising patients with Chronic Obstructive Pulmonary Disease (COPD).   "
194137|NCT00387049|"     The purpose of this study is to develop and test a smoking cessation intervention for persons     who are specifically sensitive to anxiety and anxiety-related bodily sensations.   "
194138|NCT00387062|"     The investigators hypothesize that continuous active interaction with environments that are     demanding to sensory, cognitive, and motor systems, together with imbedded rewards for     successful performance, will help improve memory and cognitive functioning in patients     suffering from chemobrain.   "
194139|NCT00387075|"     This study is designed as a prospective cohort study to test the strategy of combining two     biomarkers of parkinsonism, olfaction and brain imaging with a radioactively labeled drug,     [123I]β-CIT , in a population of first-degree relatives of PD patients as a tool to establish     an 'at risk' Parkinson disease cohort without motor symptoms of PD. First-degree relatives of     PD will be recruited through PD research sites and national foundations to participate in     this study. In addition, first degree relatives of PD patients will be recruited directly     through advertising.   "
194140|NCT00387088|"     The objective of the study is to evaluate the long-term (one year) efficacy and safety of     tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study     will examine the effect of treatment on COPD exacerbations.   "
194141|NCT00387101|"     The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard     of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment     to SOC alone.   "
194142|NCT00387114|"     The aim of the present study was to evaluate whether an in vivo treatment with an antioxidant     vitamin (vitamin C) might substantially affect serum levels of resistin, a recently described     adipokine, whose clinical significance is still controversial in humans.   "
194143|NCT00387127|"     This is a phase II study comparing the effects of lapatinib versus placebo when administered     concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or     placebo. The study is designed to evaluate and compare the two treatment groups with respect     to complete response rate at 6 months following chemoradiation completion.   "
194144|NCT00387140|"     This study is being conducted to evaluate the safety and tolerability of the drug and to     evaluate its efficacy compared to placebo and to ibuprofen in the treatment of postoperative     dental pain in male patients.   "
194146|NCT00387166|"     Cardiovascular disease (CVD) is the leading cause of death in American women, claiming on     average 40% of all female deaths each year. Although the number of CVD-related deaths in the     United States has decreased over the last several decades, the rate of decline has been less     for women than for men. Specifically, minority women of low socioeconomic status make up a     disproportionately high number of CVD cases and related deaths. Previous studies suggest     that, in addition to many other variables, psychosocial variables may contribute to ethnic     CVD disparities. More research, however, is needed to help understand and reduce these     differences. This study will examine the associations among socioeconomic status,     psychological and social factors, CVD biomarkers, and CVD in Mexican-American women.   "
194147|NCT00387179|"     Jet lag and some sleep disorders are caused by a disruption in an individual's internal     clock. Understanding the most effective way to quickly re-adjust the body's internal clock     will be beneficial for treating individuals with these conditions. This study will evaluate     the combined effectiveness of light and non-light therapies at regulating sleep cycles and     improving sleep quality.   "
194148|NCT00387192|"     The main objective of the study is to assess the pharmacokinetics of OPTIVATE® after a single     dose of 80 IU/kg VWF:RCo. The secondary objectives of the study are to assess efficacy and     safety of OPTIVATE® in long-term use over at least 12 months.   "
194149|NCT00387205|"     This study is a rollover study to evaluate the long term safety of pazopanib and to continue     to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until     pazopanib is available commercially.   "
194150|NCT00387218|"     This study is designed to compare three different exercise approaches to learn which program     is best for people with early and mid-stage Parkinson's disease. Results from this study will     help determine if participants can maintain the benefits from exercise and will help     determine which program people with Parkinson's disease are more likely to continue using.   "
194151|NCT00387231|"     Silent ischemia has been shown to negatively affect prognosis in patients after myocardial     infarction. However, long-term outcome data in totally asymptomatic patients is missing and     it is unknown whether angioplasty in addition to secondary preventive measures is superior to     antiischemic drug therapy in these patients. Therefore, the SWISSI 2 study was started 15     years ago with the aim of comparing the effects of angioplasty with medical therapy on     long-term outcome in patients with recent myocardial infarction and silent ischemia.   "
194152|NCT00387244|"     The primary objective of this study is to evaluate the efficacy of spinal cord stimulation     using the Precision implantable neurostimulation device for chronic and intractable pain of     the trunk and or limbs in patients who have failed treatment with an intraspinal infusion     pump or other SCS system.   "
194153|NCT00387257|"     The purpose of this study is to compare the effects of repeat doses of SB-659032 with placebo     on platelet aggregation in subjects.   "
194154|NCT00387270|"     This study is being conducted to determine the safety and tolerability of Dimebon in people     with Huntington's disease after short-term exposure (one week) and after longer exposure     (three months). Also, the study will assess whether or not there is an effect of Dimebon on     the symptoms of Huntington's disease, including cognitive (thinking abilities), motor     (movement), behavior, and overall functioning.   "
194155|NCT00387283|"     During a clinical study of people with severe West Nile virus infections, it was determined     that the drug AVI-4020 crossed the blood-brain barrier. This study will assess the amount of     drug that goes across the blood-brain barrier and the drug levels measured in both the blood     and urine.      The objective of this study is to find out how much and how fast this drug crosses this     barrier.   "
194156|NCT00387296|"     The study's aim is to determine whether use of a mechanical device can improve the timeliness     of anesthesia provided by liposomal lidocaine cream. Liposomal lidocaine cream has     historically come in the brandnames of ELA-Max and LMX, with either 4% or 5% lidocaine in the     cream. In this protocol, the abbreviation LLC will be generally used to refer to the 4%     concentration to be used in FAST Lidocaine. Regardless of the concentration used, the     encapsulation of lidocaine in liposomes protects the anesthetic from rapid metabolism and     allows the medication to remain in the epidermis, yielding a theoretical benefit of     long-lasting anesthesia.1 The test device is a painless functional microarray (FMA) that     renders hundreds of microscopic punctures per cm2 in a patient's stratum corneum. The holes     in the stratum corneum subsequently allow for faster movement of LLC into the skin to be     anesthetized.      Currently, topical anesthetics are used less commonly in the Emergency Department (ED) than     would be the case if the available approaches were not associated with such long onset times.     The most commonly utilized topical anesthetic for intact skin, eutectic mixture of local     anesthetics (EMLA), requires at least an hour for anesthetic effect; maximal effect requires     up to 2 hours.2, 3 4 The topical anesthetic to be used in the FAST Lidocaine study, 4% LLC,     has a roughly equipotent analgesic effect to that of EMLA and works faster, but must still be     in place for at least a half-hour before onset of reliable anesthesia.1, 5-8 Commentators     have judged such delays considerable and written that because of long application times,     use of topical anesthetics may not be practical.1, 8-10 In discussing agents (such as LLC)     that are formulated for more rapid transcutaneous absorption, ED wound care experts have     written that their delayed onset limits their use in the emergent setting.11 It has also     been noted that LLC's utility is potentially diminished by the fact that anesthesia may begin     to wear off as soon as 10 minutes after cream removal.8 Given the previously outlined     findings, it is obvious that there is room for improvement in ED delivery of topical     anesthesia. The goal of rendering topical anesthesia practical - and thus more likely to be     used - constitutes the basis for the FAST Lidocaine study. We seek to identify whether a     novel approach safely and painlessly improves the onset time (and perhaps depth) of topical     anesthesia.      Reducing pain caused by procedures involving violation of the skin barrier (e.g. intravenous     [IV] line placement, anesthesia and suturing of wounds) is an important goal. Needlesticks     and IV catheters have been identified as important causes of pain in both children and     adults.8, 12, 13 In terms of frequency, U.S. EDs place over 20 million IV catheters and care     for over 10 million wounds.9 Thus, there is potentially broad-based utility in a potentiator     for local anesthesia absorption in the ED.      The importance of the clinical goal of improving absorption of topical anesthesia has already     prompted efforts aimed at improving delivery and efficacy of topically applied local     anesthetics. Previous investigations have demonstrated utility - and limitations - of various     methods of traversing and/or stripping the stratum corneum. Among the techniques studied have     been use of electrical energy (iontophoresis),14 sound waves (sonophoresis),15, 16 adhesive     tape17-19 and lasers.11, 12, 20, 21 While these varying approaches all have promise, their     limitations leave room for assessment of a new method if it promises to be safe, painless,     and effective.      The approach of the FAST Lidocaine study will be to assess FMA use. The FMA is a painless     mechanism that is placed on the skin with minimal pressure. It creates microscopic punctures     in the stratum corneum, facilitating movement of anesthetic through the cutaneous barrier.     The device's physical characteristics, namely its easy application and low apparent potential     for incorrect or unsafe use, appear quite suitable for ED utilization. If it works, the FMA     would be immediately useful in a variety of circumstances.      The overarching goal of the FAST Lidocaine investigators is to assess whether the FMA can     improve management of procedure-related pain in the ED. The main problem in terms of ED use     of the currently available topical anesthetics - whether EMLA, LMX, or others - is the time     of onset, rather than anesthetic efficacy. Thus, it is the timing impracticality for most ED     situations that is the spur for FAST Lidocaine. The study's primary focus and endpoint will     be time to anesthesia. Secondary analysis will evaluate whether the depth of anesthesia is     improved by assessing the nadir of visual analog scale (VAS) assessments. However, it is     noteworthy that deeper anesthesia is not necessary in order to establish the potential     utility of FMA in the acute care setting.   "
194157|NCT00387309|"     Primary Objective: In subjects who have undergone segmental colectomy, the time between the     end of surgery and first bowel movement is significantly shorter with the investigational     MOA-728 regimen than with a placebo regimen.   "
194158|NCT00387322|"     RATIONALE: Pemetrexed disodium and erlotinib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Giving pemetrexed disodium together with     erlotinib may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of two different     schedules of pemetrexed disodium and erlotinib and to see how well they work in treating     patients with advanced non-small cell lung cancer or other solid tumors.   "
194159|NCT00387335|"     This phase II trial is studying how well sunitinib works in treating patients with recurrent     and/or metastatic head and neck cancer. Sunitinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
194160|NCT00387348|"     RATIONALE: Escitalopram may help improve depression and quality of life in patients with     advanced lung or gastrointestinal cancer. It is not yet known whether escitalopram is more     effective than a placebo in treating depression in patients with advanced lung or     gastrointestinal cancer.      PURPOSE: This randomized clinical trial is studying the side effects of escitalopram and to     see how well it works compared to a placebo in treating depression in patients with advanced     lung or gastrointestinal cancer.   "
194172|NCT00387504|"     RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide in     treating patients with metastatic or unresectable malignant solid tumors.   "
194173|NCT00387517|"     The purpose of this trial is to evaluate the safety and efficacy of combination therapy of     aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in     patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.   "
194161|NCT00387361|"     The purpose of this study is to determine if Osteopathic Manipulative Treatment (OMT) is     effective in reducing nausea and vomiting experienced by patients recovering from anesthesia.     OMT is a treatment in which the physician places his hands on areas of the body and applies     pressure to correct disturbances in one area that may be related to a problem in another area     of the body. Osteopathic Manipulative Medicine is a specialty for a physician who uses OMT.      The hypothesis of this study is when OMT is combined with standard-of-care prophylactic     anti-emetic therapy in patients following administration of inhalational anesthesia, in     comparison to a control group receiving only standard-of-care anti-emetic prophylaxis there     will be a reduction in the incidence and severity of PONV.   "
194162|NCT00387374|"     This phase II trial is studying the side effects and how well giving radiation therapy     together with bevacizumab, paclitaxel, and carboplatin works in treating patients with     unresectable stage IIIB or stage IV non-small cell lung cancer at high risk for hemoptysis     caused by bevacizumab. Radiation therapy uses high-energy x-rays to kill tumor cells. It may     also prevent hemoptysis caused by bevacizumab. Monoclonal antibodies, such as bevacizumab,     can block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to     the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving radiation therapy together with bevacizumab and chemotherapy may kill more     tumor cells   "
194163|NCT00387387|"     This study will test the safety of treating colorectal cancer with a combination of drugs.     The current standard treatments of FOLFOX6 or CapeOx will be give in combination with the GSK     investigational drug pazopanib.   "
194164|NCT00387400|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. Giving temozolomide together with everolimus     may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when     given together with temozolomide in treating patients with newly diagnosed, recurrent, or     progressive malignant glioblastoma multiforme.   "
194165|NCT00387413|"     GSK189254 is a highly potent histamine 3 (H3) receptor antagonist which has demonstrated     efficacy in the reduction of mechanical hyperalgesia and allodynia in the chronic     constriction injury pre-clinical model of neuropathic pain (NP). The mechanism of action of     GSK 189254 in the pain model is hypothesised to be via enhanced release of monoamines in the     central nervous system (CNS). A similar mechanism of action has also been shown for     duloxetine. In this phase I study, the safety and efficacy of GSK189254 will be investigated     in the electrical hyperalgesia (EH) model in healthy volunteers to build confidence that the     preclinical efficacy demonstrated by this compound will translate into patients.      This study will be conducted as a double-blind, double-dummy, placebo-controlled, incomplete     block, two period crossover study. Up to 40 healthy male or female volunteers, aged 18-45     years old, will be randomised into the study in order to achieve 32 evaluable subjects.     Subjects will undergo two 3-week treatment periods and will be randomised to receive placebo     and either GSK189254 (up to 100µg once daily) or duloxetine (up to 60mg daily). There will be     a one week washout between treatment periods. The effects of repeated oral dosing of     GSK189254 and duloxetine on secondary hyperalgesia in the EH model will be determined.     Subject: GSK189254, Neuropathic pain (NP), H3 antagonist, duloxetine, Electrical     hyperalgesia, Phase I, Healthy volunteers, Double blind, Safety, tolerability.   "
194166|NCT00387426|"     This phase II trial is studying how well sunitinib works in treating patients with idiopathic     myelofibrosis. Sunitinib may stop the growth of abnormal cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the abnormal cells.   "
194167|NCT00387439|"     The purpose of this study is to evaluate the impact of anoperineal physiotherapy in     adjunction to standard medical treatment on symptoms and quality of life of adults with anal     incontinence, in comparison with standard treatment alone.      A total of 443 patients will be randomized to 2 groups: standard care (medical treatment)     alone or standard care associated with anoperineal physiotherapy. Outcome measures include     the patient own view of the effectiveness of the treatment, the continence score, quality of     life and psychological status. These outcomes are measured at the end of the 4 months     treatment period.      Following this period, the non responders to standard medical treatment will be proposed to     undergo a course of anoperineal physiotherapy and the non responders to anoperineal     physiotherapy will be treated by transcutaneous electrical nerve stimulation (TENS). The     outcomes will be measured at the end of the 4 months new treatment and again after 4 months     follow-up.   "
194168|NCT00387452|"     Older persons with diabetes have a harder time maintaining blood pressure when standing up.     When blood pressure drops when standing up, fainting may occur. This study will see how     regular exercise can improve the ability of the body to keep blood pressure up when standing.     We want to see how this improvement varies with different types of exercise. The types of     exercise that we will be studying are aerobic (running or cycling on a stationary bike) and     strength training (weight lifting).   "
194169|NCT00387465|"     This phase I/II trial is studying the side effects and best dose of azacitidine when given     together with entinostat and to see how well they work in treating patients with recurrent     advanced non-small cell lung cancer. Azacitidine and entinostat may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together     with entinostat may kill more tumor cells.   "
194170|NCT00387478|"     Tree MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients     with hypersensitivity to Tree (birch, alder, hazel) pollen (hay fever). This novel     formulation is designed to provide a vaccine that will be efficacious with only four     escalating dose injections administered before the start of the pollen season. In this Study     the Efficacy will be assessed by exposing allergic subjects to birch pollen in an     environmental exposure chamber EEC. Patient symptomatic response to birch pollen and patient     quality of life in the EEC will be determined.   "
194171|NCT00387491|"     To assess the effect of a single oral dose of MOA-728, an investigational drug, on the     oral-cecal transit time in subjects who are taking methadone.   "
194174|NCT00387530|"     RATIONALE: The Epstein-Barr virus can cause cancer and lymphoproliferative disorders.     Valganciclovir is an antiviral drug that acts against the Epstein-Barr virus. Phenylbutyrate     may make cells infected with Epstein-Barr virus more sensitive to valganciclovir. Giving     phenylbutyrate together with valganciclovir may block the growth of Epstein-Barr     virus-infected cells and kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving phenylbutyrate together with     valganciclovir works in treating patients with relapsed or refractory Epstein-Barr     virus-positive cancer.   "
194175|NCT00387543|"     Discussion and evaluation of patients with sore and burning mouth to determine whether alpha     lipoic acid is helpful in managing their symptoms.   "
194179|NCT00387595|"     Family history of early atherosclerotic disease in a first-degree relative [(FDR) sibling,     parent or child] is an important risk factor for coronary artery and/or vascular disease. The     risk increases ~ 2 - 7 times over that of general population. Increased thickness of the     intima and media of carotid arterial wall, increased rate of plaque formation is an     independent predictor of cardiovascular disease. Also it is shown that increased level of     calcium deposition in the arterial wall is also associated with increased level of coronary     artery narrowing. We will assess the occurrence and severity of abnormalities of intima media     thickness (IMT) and/or plaque formation and increased calcium deposition in the coronary     arteries and their relation to the well known traditional risk factors (plasma glucose,     smoking, BMI, waist circumference, blood pressure, total cholesterol, low density     lipoprotein, total cholesterol/high density lipoprotein ratio) and non-traditional risk     factors (C-reactive protein, Lpa, homocysteine) in FDRs of index patients with early onset of     heart or vascular disease and appropriate control population. Also to determine which of the     above factor can assess IMT and Ca score better. This may help to reduce the cost of     investigation, and to identify the population at high risk of developing cardiovascular     disease, which may help the physicians to treat early on before cardiovascular complications     occur. Also this may help to reduce the cost of invasive tests, hospital admissions and     medical costs overall by reducing the morbidity and mortality.   "
194180|NCT00387608|"     RATIONALE: ABT-888 may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth. Collecting and storing samples of blood from patients with cancer to study     in the laboratory may help doctors learn more about the ways a patient's body handles the     drug.      PURPOSE: This early phase I trial is studying the side effects and best dose of ABT-888 in     patients with refractory solid tumors or hematologic cancer.   "
194181|NCT00387621|"     In congestive heart failure, cardiac output is low, blood pressure is high, and the body     becomes congested with fluid. In normal people, when there is high blood pressure, the heart     muscle cells secrete a hormone that excretes sodium and water in the urine, reducing blood     pressure. The action of this hormone is called the natriuretic response. The purpose of this     study is to determine if nesiritide can improve an impaired natriuretic response in subjects     with asymptomatic systolic heart failure or asymptomatic diastolic heart failure.   "
194182|NCT00387634|"     evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5     years after first TBE booster   "
194183|NCT00387647|"     The purpose of this study is to find out if patients older than 60, with acute myeloid     leukemia, who are in complete remission following initial chemotherapy, will live longer and     have a lower rate of leukemia relapse when treated with azacitidine.   "
194184|NCT00387660|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin     works in treating patients with metastatic or recurrent small cell lung cancer.   "
194185|NCT00387673|"     Electrical stimulation (pulses of electricity applied over the skin of your wrist) and     activity-based hand exercise have been shown to improve motor skill and strength in     individuals with stroke and have recently been shown to also have an effect on individuals     with spinal cord injury. Therefore, the purpose of this research study is to investigate     whether electrical stimulation alone or electrical stimulation followed by activity-based     training produces gains in pinch strength (how hard you can squeeze your thumb and pointer     finger together) and upper extremity function (how well your arm and hand can perform     activities) in individuals with spinal cord injury.   "
194186|NCT00387686|"     The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM     administered at the fracture site via percutaneous injection, in combination with standard of     care, accelerates fracture union and return to normal function in subjects who have a closed     diaphyseal tibial fracture when compared to standard of care alone.   "
194187|NCT00387699|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some find tumor cells and help kill them or carry tumor-killing substances to them.     Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also     stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy     uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with cisplatin,     etoposide, and radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with cisplatin,     etoposide, and radiation therapy works in treating patients with limited-stage small cell     lung cancer.   "
194188|NCT00387712|"     The purpose of this study is to first define whether abnormalities of skeletal muscle are     related to the presence of inflammation and to poor motor performance and whether this can be     modified by exercise interventions.   "
194191|NCT00387751|"     This phase II trial is studying how well giving bevacizumab together with sorafenib works in     treating patients with unresectable stage III or stage IV malignant melanoma. Monoclonal     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop     the growth of melanoma by blocking blood flow to the tumor. Giving bevacizumab together with     sorafenib may kill more tumor cells.   "
194220|NCT00381563|"     Osteoarthritis, sometimes called degenerative joint disease, is the most common form of     arthritis. It occurs when the cartilage in joints wears down over time. Symptoms can include     pain, tenderness, stiffness, and inflammation. Studies have suggested that symptoms of knee     osteoarthritis may be caused by abnormalities at the patellofemoral joint, which is the joint     between the kneecap, called the patella, and the thigh bone, called the femur. This study     will determine whether wearing a knee brace that realigns the patella over the femur is     effective in relieving pain and improving function in adults with knee osteoarthritis.   "
194192|NCT00387764|"     This is an open-label, international, multi-center study designed to provide access to     pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study     (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once     daily. The study treatment will continue until subjects experience disease progression,     unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is     to evaluate the safety and tolerability of pazopanib for the treatment of renal cell     carcinoma. The secondary objectives of the study are to assess response rate (defined as     complete response or partial response), progression-free survival, and overall survival.     Response rates will be collected per investigator assessment (no central review). Subjects     will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter.   "
194193|NCT00387777|"     The purpose of this study is to determine whether Transtec(R) PRO 70 µg/h and a new     buprenorphine patch formulation lead to same plasma levels of buprenorphine after multiple     dose application.   "
194194|NCT00387790|"     This phase II trial is studying how well giving motexafin gadolinium together with radiation     therapy works in treating young patients with pontine glioma. Radiation therapy uses     high-energy x-rays to kill tumor cells. Drugs, such as motexafin gadolinium, may make tumor     cells more sensitive to radiation therapy. Giving motexafin gadolinium together with     radiation therapy may kill more tumor cells.   "
194195|NCT00387803|"     The purpose of this study was to determine if cardiac resynchronization therapy when combined     with defibrillation is safe and effective in the treatment of symptomatic heart failure.   "
194196|NCT00387829|"     To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an     adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and     radicular pain in comparison to a control group receiving standard care.   "
194197|NCT00387842|"     COLOR trial is a randomized, international, multi center study comparing the outcomes of     laparoscopic and conventional resection of colon carcinoma with curative intent. Clinical and     operative data will be collected centrally in the coordinating centre in Rotterdam, The     Netherlands. Quality of life and costs will be assessed on a national basis.   "
194198|NCT00387855|"     The purpose of this study was to investigate the impact of the SOS suicide prevention program     on help-seeking, attitudes toward depression and suicide, and suicidal behavior among high     school students. Current research protocol has extended this evaluation to the Middle School     version of SOS.   "
194199|NCT00387868|"     This is a phase II study for patients with thymoma or thymic carcinoma thought to be at     significant risk for recurrence following surgical removal. This study involves the use of     combined chemotherapy and radiation therapy prior to surgery, in hopes of increasing the     chances of complete resection. The chemoradiotherapy protocol is one which has been used     extensively for other diseases, and the side effects are therefore well-documented. Patients     with thymomas thought to be at significant risk for recurrence (by x-ray and pathology     criteria) will be allowed to participate, and will undergo combined chemotherapy with     radiation to the chest followed by surgical removal of the tumor and postoperative     chemotherapy. The main outcome measured will be the rate of pathological complete response     (e.g. no active tumor in the resected specimen) to the preoperative treatment. Patients will     receive postoperative treatment based on surgical and pathologic criteria.   "
194200|NCT00387881|"     This study was designed to determine the efficacy and tolerability of TREXIMET (formerly     known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a     sub-type of migraine.   "
194201|NCT00387894|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with     recurrent glioblastoma multiforme or gliosarcoma.   "
194202|NCT00387907|"     The purpose of this study is to evaluate the anti-tumor activity of the combination of     experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast     cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or     MRI scans. Additional goals of this study are to look at patient safety, to determine how     long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects     the study medications may have on each other, and to find out how long patients remain cancer     free on this study treatment.   "
194203|NCT00387920|"     This phase I trial is studying the side effects and best dose of sunitinib in treating young     patients with refractory solid tumors. Sunitinib may stop the growth of tumor cells by     blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor.   "
194204|NCT00387933|"     RATIONALE: Imatinib mesylate, vatalanib, and hydroxyurea may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Vatalanib may also stop the growth of     tumor cells by blocking blood flow to the tumor. Giving imatinib mesylate and vatalanib     together with hydroxyurea may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate     and vatalanib when given together with hydroxyurea in treating patients with recurrent or     relapsed malignant glioma.   "
194205|NCT00387946|"     The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking     cessation in cigarette smokers. The main secondary objectives are to assess the: craving for     cigarettes, nicotine withdrawal symptoms, and safety of dianicline.   "
194236|NCT00381784|"     One of the objectives of the C2P coalition is the successful delivery of a CDC-endorsed     community-level HIV prevention program aimed at changing the risk profiles of youth. This     protocol (ATN 041) describes the program, Community PROMISE (Peers Reaching Out and Modeling     Intervention Strategies) or MPowerment, and plans for adapting and implementing it. There are     a total of 4 interventions that a community can implement.   "
194221|NCT00381576|"     The purpose of the present investigation is to determine whether MS patients can tolerate and     benefit from heavy progressive resistance training. A second purpose is to determine both     neural and muscle morphological adaptations to heavy progressive resistance training.   "
194222|NCT00381589|"     Hypersalivation (Too much saliva) and drooling is a side effect experienced by 31% of people     taking the antipsychotic clozapine. This study aims to determine if using the medication     ipratropium bromide(IPB)at bedtime will reduce the amount of salivation and the distress     people may feel.   "
194206|NCT00387959|"     RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine,     total-body irradiation, and rituximab before a donor umbilical cord blood stem cell     transplant helps stop the growth of cancer cells. It also stops the patient's immune system     from rejecting the donor's stem cells. The donated stem cells may replace the patient's     immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).     Sometimes the transplanted cells from a donor can also make an immune response against the     body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may     stop this from happening.      PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy     together with rituximab and an umbilical cord blood transplant works in treating patients     with B-cell non-Hodgkin's lymphoma.   "
194207|NCT00387972|"     GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral     therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability     of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2     diabetes mellitus.   "
194208|NCT00387985|"     Primary: To determine the bioequivalence between the new formulation and the current     formulation of the investigational drug, MOA-728.   "
194209|NCT00387998|"     RATIONALE: Understanding the risk of disease and prevention and screening activities to lower     disease risk may help individuals make informed medical decisions.      PURPOSE: This randomized clinical trial is studying how well health education materials help     participants understand medical information.   "
194210|NCT00388011|"     Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray     (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo     in patients with moderate to severe post-surgical pain following orthopedic surgery. After     initial dosing, up to six (6) doses of IN MNS075 7.5 mg or 15 mg for up to twenty-four (24)     hours will be evaluated. The rescue dose remained the same for each.   "
194211|NCT00388024|"     RATIONALE: Imaging procedures, such as PET scan and CT scan, may help doctors predict a     patient's response to treatment and plan the best treatment.      PURPOSE: This clinical trial is studying how well PET scans and CT scans show response to     treatment in patients with locally advanced head and neck cancer undergoing chemotherapy and     radiation therapy.   "
194212|NCT00388037|"     This phase II trial studies the side effects and how well sunitinib malate works in treating     patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.     Sunitinib malate may inhibit the ability of cancers to grow blood vessels, something they     need to grow. It may also shrink tumors.   "
194213|NCT00388050|"     The purpose of this study is to examine how different ways of sharing information about     diabetes medication treatment options with patients can affect their choices and health.   "
194214|NCT00381472|"     The purpose of this double-blind, placebo controlled study is to evaluate the safety and     effectiveness of an investigational Parkinson's disease drug in patients with advanced     disease who are not well-controlled on their L-dopa medication.   "
194215|NCT00381485|"     This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy     of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice     daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind     treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during     the run-in period. Efficacy will be measured by the area under the curve from 0 to 12 hours     [AUC](0-12 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory     volume in one second (FEV1).   "
194216|NCT00381511|"     Background. Management of patients with suspected Pulmonary Embolism (PE) is problematic if     diagnostic imaging is not available. Pretest Clinical Probability (PCP) and D-dimer (D-d)     assessment were shown to be useful to identify those high risk patients for whom empirical,     protective anticoagulation is indicated.      To evaluate whether PCP and D-d assessment, together with the use of low molecular weight     heparins (LMWHs), allow objective appraisal of PE to be deferred for up to 72 hours, we     planned to prospectively evaluate consecutive patients with suspected PE.      Methods. In case of deferment of diagnostic imaging for PE, patients identified at high-risk     (those with high PCP or moderate PCP and positive D-d), receive a protective full-dose     treatment of LMWH; the remaining patients will be discharged without anticoagulant. All     patients will be scheduled to undergo objective tests for PE within 72 hours. Standard     antithrombotic therapy will be then administered when diagnostic tests confirmed Venous     ThromboEmbolism (VTE).   "
194217|NCT00381524|"     In the third decade of the HIV pandemic, what was once a uniformly and rapidly fatal disease     has been transformed into a chronic illness by advances in the understanding of HIV     pathogenesis and therapeutics. As a result, HIV-infected individuals are living longer and     better lives. This phenomenon, coupled with a continued steady rate of new HIV infections in     this country, has led to the highest U.S. HIV prevalence rates since the beginning of the     epidemic. In the past, HIV prevention efforts were separate from routine primary care     delivery due to multiple factors including stigma and time constraints. Recent events,     including increases in sexually transmitted disease (STD) rates among HIV-infected persons     and evidence that infected individuals can be super-infected by HIV strains resistant to     antiretroviral therapy, have inspired the SPNS program initiative to develop demonstration     projects for interventions to reduce risky sexual exposures among HIV-infected patients     receiving primary care.   "
194218|NCT00381537|"     Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood     epilepsy in Bangladesh with particular reference to behavioural side effects.   "
194219|NCT00381550|"     This phase II trial is studying how well giving 3-AP together with fludarabine works in     treating patients with myeloproliferative disorders (MPD), chronic myelomonocytic leukemia     (CMML), or accelerated phase or blastic phase chronic myelogenous leukemia. Drugs used in     chemotherapy, such as 3-AP and fludarabine, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. 3-AP may help     fludarabine work better by making cancer cells more sensitive to the drug. 3-AP and     fludarabine may also stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth. Giving 3-AP together with fludarabine may kill more cancer cells.   "
194290|NCT00388362|"     To study the effectiveness of an immunosuppressive drug sirolimus, in the treatment of     chronic graft versus host disease in combination with prednisone.   "
194223|NCT00381602|"     Malnutrition and altered protein catabolism are serious problems in renal failure and     hemodialysis (HD) patients. The purpose of this study is to characterize the safety of     GHRP-1/AG in subjects with ESRD on HD; to characterize the pharmacodynamics (PD) of GHRP-1/AG     in subjects with ESRD on HD by following GH and IGF-1; to describe the relationship between     GHRP-1 PD and plasma concentrations of GHRP-1 and des-Ala-GHRP-1; and to evaluate the     preliminary efficacy of GHRP-1/AG on nutritional status of subjects with ESRD on HD using     subjective global assessment of malnutrition inflammation scores (MIS) and changes in caloric     intake.   "
194224|NCT00381615|"     This study was aimed to explore safety and immunogenicity of two formulations of a     Meningococcal B Vaccine when administered to healthy infants.   "
194225|NCT00381628|"     Study Hypothesis: We hypothesize that cellular markers from nasal epithelial cells and blood     lymphocytes can serve as potential biomarkers reflect the underlying inflammatory state of     the lung and will be helpful in determining the presence of a CF pulmonary exacerbation and     its overall severity.   "
194226|NCT00381641|"     This phase II trial studies how well sunitinib malate works in treating patients with thyroid     cancer that did not respond to iodine I 131 (radioactive iodine) and cannot be removed by     surgery. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.   "
194227|NCT00381654|"     AV-412 is a new oral therapy developed to inhibit the growth of solid tumors in patients who     have not responded to standard therapy or surgical interventions, or who have experienced     relapse. This study will test the safety of AV-412 and determine the maximum tolerated dose     for the treatment of solid tumors.   "
194228|NCT00381667|"     This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine     GW642444M via the inhaled route and will assess the efficacy, safety, tolerability,     pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25,     100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre,     placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients.      Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will     be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical     laboratory safety tests, collection of adverse events and blood samples.   "
194229|NCT00381680|"     This randomized phase III trial is studying low-dose vincristine to see how well it works     compared with high-dose vincristine when given together with different combination     chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute     lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth     of cancer cells, either by killing the cells or by stopping them from dividing. Giving more     than one drug (combination chemotherapy) and giving the drugs in different ways and different     doses may kill more cancer cells..   "
194230|NCT00381693|"     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop     the growth of abnormal cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with     myelofibrosis.   "
194231|NCT00381706|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor     cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Giving more than one chemotherapy drug (combination chemotherapy)     together with cetuximab may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying three different combination chemotherapy     regimens to compare how well they work when given together with cetuximab in treating     patients with metastatic esophageal cancer or gastroesophageal junction cancer.   "
194232|NCT00381719|"     This study will explore the safety and effectiveness of different doses of AGN 203818 in     treating pain in patients with painful diabetic peripheral neuropathy   "
194233|NCT00381732|"     This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to     evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with     erectile dysfunction.   "
194234|NCT00381758|"     This study was designed to compare Concerta Extended Release tablets with Metadate CD     capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD     symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a     simulated classroom. The treatments were blinded and the effects were compared with a     Placebo.   "
194235|NCT00381771|"     It is well known that 'globus sensation in throat' is caused by the chronic irritation and     inflammation of oral, pharyngeal, or laryngeal mucosa, such as laryngopharyngeal reflux and     chronic postnasal drip.      Xerostomia and pharyngoxerosis due to salivary hypofunction also proved to induce the mucosal     change of the oral cavity and pharynx.      However, no previous studies have documented the prevalence of salivary hypofunction in     patients with globus pharyngeus.      Through this clinical investigation, we hypothesized that the salivary hypofunction might be     one of the leading cause of globus pharyngeus.   "
194237|NCT00381797|"     This phase II trial is studying how well giving bevacizumab together with irinotecan works in     treating young patients with recurrent, progressive, or refractory glioma, medulloblastoma,     ependymoma, or low grade glioma. Monoclonal antibodies, such as bevacizumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab     may also stop the growth of glioma by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving bevacizumab together     with irinotecan may kill more tumor cells.   "
194238|NCT00381810|"     This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the     safety and efficacy of rituximab when administered on a scheduled basis every 6 months over     the course of 1 year with reassessment of response at 12 months. This study is open to     participants previously enrolled in Genentech Study U2971g only.   "
194239|NCT00381823|"     The purpose of this study is to determine if an integrated intervention addressing active     smoking, environmental tobacco smoke exposure, depression and intimate partner violence,     would improve pregnancy outcome among African American women.   "
194240|NCT00381836|"     The purpose of this study is to determine whether or not Aranesp® (Darbepoetin Alfa),     administered every fourth week, is effective in the treatment of blood shortage (anemia)     compared to standard care of treatment (blood transfusions) in patients with anemia due to     hormone refractory prostate cancer.   "
194241|NCT00381849|"     We will investigate the safety and effectiveness of a mixture of 9 east Indian herbs known as     Cystone regarding their ability to dissolve existing kidney stones and prevent formation of     new ones. Cystine and calcium stone formers will be recruited for a 59 week trial. The first     phase of the study will be two 6 weeks periods during which each subject will receive Cystone     or placebo in random order (with a one-week wash out between 6 week treatment periods). The     remaining 46 weeks, each subject will receive Cystone. End points are changes in urinary     chemistries and stone burden by Computerized Tomography (CT) scanning.   "
194242|NCT00381862|"     RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and     vomiting in patients receiving chemotherapy.      PURPOSE: This phase II trial is studying how well giving aprepitant together with     palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy     in patients receiving chemotherapy for metastatic colorectal cancer.   "
194243|NCT00381875|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response.     Incomplete Freund's adjuvant may stimulate the immune system in different ways and may help     the vaccine work better. Colony-stimulating factors, such as GM-CSF, may increase the number     of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together     with incomplete Freund's adjuvant and GM-CSF may be an effective treatment for patients with     HIV.      PURPOSE: This clinical trial is studying how well giving vaccine therapy together with     incomplete Freund's adjuvant and GM-CSF works in treating patients with HIV.   "
194244|NCT00381888|"     RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are     undergoing surgery for gynecologic cancer.      PURPOSE: This phase II trial is studying how well fondaparinux works in preventing blood     clots in patients undergoing surgery for gynecologic cancer.   "
194245|NCT00381901|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. It is not yet known whether giving     trastuzumab for 6 months is as effective as giving trastuzumab for 1 year in treating     patients with breast cancer.      PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works     when given for 6 months compared to 12 months in treating women with nonmetastatic breast     cancer that can be removed by surgery.   "
194246|NCT00381914|"     The research team is comprised of an expert nutrition scientist and a pediatrician with     expertise in endocrinology. Both have world-class experience in assessing bone mass in     infancy. Together they have designed a study to determine how much dietary vitamin D is     needed to optimize health in infants. This is important since many infants are born with     vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is     unclear and recent research suggests that vitamin D status very early in life has long     lasting effects on bone mass and other health issues. Therefore, in a group of healthy     infants, this research team will test which dosage of vitamin D is needed to achieve optimal     vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D     and bone status in blood and also general health. The infants will all be breastfed and begin     the study at about 2 weeks of age. At 3 months intervals over the first year of life, each     infant will be measured for growth, duration of breastfeeding and supplement use plus have a     bone density scan to determine changes in bone growth. The data will be helpful to guide     health care professionals in providing the best care possible for their infants. It will also     be important to the health of populations since dietary recommendations for vitamin D are     used to guide fortification of foods and development of evidence based policy around nutrient     recommendations and their implementation.   "
194247|NCT00381927|"     To evaluate 1) the extent of patient overestimation of breast cancer development risk in     subjects referred to a physician-based high-risk breast clinic; 2) the ability of physician     counseling to improve patient risk perception and reduce psychological distress; 3) to     identify factors relevant in clinical practice associated with increased distress and risk     perception.   "
194248|NCT00381940|"     This phase II trial studies the side effects and efficacy of bortezomib with ifosfamide and     vinorelbine in children and young adults with Hodgkin's lymphoma that was recurrent or did     not respond to previous therapy. Bortezomib is an inhibitor of protein degradation.     Bortezomib degrades short-lived regulatory proteins in the cell, and has been reported to     increase the tumor cells. Bortezomib may increase the effectiveness of ifosfamide and     vinorelbine (two standard drugs given to children with Hodgkin Lymphoma that has come back     after initial treatment) by making cancer cells more sensitive to effectiveness of standard     chemotherapy by preventing anti-death responses in these drugs. Giving bortezomib together     with ifosfamide and vinorelbine tartrate should kill more cancer cells than are killed with     ifosfamide and vinorelbine alone.   "
194249|NCT00381953|"     The purpose of this study is to compare pharmacokinetics by IFN assays and pharmacodynamics     by patient's HCVRNA suppression of 360 mug peginterferon QW, 9 MU interferon daily or 4,5 MU     interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of     treatment. Comparison of virological breakthrough/relapse rate after dose adjustments and     sustained virological response rate will be assessed by the type of induction.   "
194250|NCT00381966|"     This is a study that will try see if a device can help to better guide the needle that places     prostate cancer treatment.   "
194251|NCT00381979|"     The purpose of the study is to investigate the effectiveness of providing Supportive     Expressive Therapy to adolescents who are depressed and/or anxious.   "
194266|NCT00382187|"     The present study aims to evaluate safety and immunogenicity of two doses, administered three     weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms     or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine     containing 15 micrograms of H5N1 influenza antigen, in adults   "
194398|NCT00389883|"     This is a double center, multidisciplinary, prospective, randomized, double-blind, with a     superiority hypothesis, trial including 100 patients scheduled for resection of a     supratentorial brain tumour under general anesthesia.   "
194252|NCT00381992|"     International studies have repeatedly documented a substantial prevalence of sexual risk     behaviors and high rates of human immunodeficiency virus (HIV) and other sexually transmitted     infections (STI) ranging from 5%-56% amongst long-distance truck drivers (truckers) living     in diverse international settings including India, Bangladesh, South Africa, China, Laos and     Thailand. The prevalence of sexual risk factors and STI/HIV in US drivers is unknown. This     proposal will provide both qualitative and quantitative data on HIV risk behaviors by     interviewing and testing truckers working for established long-distance trucking firms, the     sector which accounts for most of the jobs in the trucking and warehousing industry in the     United States. The data obtained from this study will be used to inform the development of an     HIV prevention intervention for long-haul truck drivers.   "
194253|NCT00382018|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Measuring blood levels     of tumor cells may help in learning how well chemotherapy works to kill metastatic breast     cancer cells and allow doctors to plan better treatment. When blood levels of tumor cells are     high while receiving chemotherapy, it is not yet known whether it is more effective to change     chemotherapy regimens at that time or wait until disease progression.      PURPOSE: This randomized phase III trial is studying treatment decision making based on blood     levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.   "
194254|NCT00382031|"     The purpose of this study is to investigate if zalutumumab in combination with Best     Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer   "
194255|NCT00382044|"     The purpose of this study is to audit the effects of changing all hemodialysis patients from     intravenous to subcutaneous administration of ESA's, to ensure that a cost-saving is achieved     and that this does not occur at the expense of anemia control. The dose changes will occur     according to usual clinical care of patients and not along a protocol.   "
194256|NCT00382057|"     The metabolic syndrome is a medical condition defined by high levels of cholesterol in the     blood, high blood pressure, central obesity (gain in fat around the region of the stomach),     and insulin resistance (body responds less well to insulin). This state of impaired insulin     resistance can lead to type 2 diabetes mellitus, which is one of the most common metabolic     disorders in the U.S. Numerous studies have shown an inverse relationship between insulin     resistance and testosterone levels in men, however, causality has not been established. This     protocol investigates the role of testosterone in modulating insulin sensitivity in insulin     resistant states such as the metabolic syndrome. The hypothesis is that testosterone     administration will improve insulin sensitivity.   "
194257|NCT00382070|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is     not yet known whether letrozole is more effective than a placebo in treating patients with     hormone receptor-positive breast cancer.      PURPOSE: This randomized phase III trial is studying letrozole to see how well it works     compared with a placebo in treating postmenopausal women who have received hormone therapy     for hormone receptor-positive breast cancer.   "
194258|NCT00382083|"     This study will explore the effect of pre-medication with acetaminophen, ibuprofen, and     topical lidocaine gel (Topicaine) on the perception of discomfort and overall satisfaction     with the mammography experience.      The research questions are:        1. What is the relationship between the use of acetaminophen, ibuprofen, and Topicaine          prior to screening mammography and the perception of discomfort during the procedure?        2. What is the relationship between perception of discomfort and overall satisfaction with          the mammography experience?        3. What is the relationship between the perception of discomfort and plans for future          mammograms?        4. What other factors are associated with the perception of discomfort and satisfaction?   "
194259|NCT00382096|"     The purpose of this study is to evaluate the efficacy and safety of a fixed combination of     vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes   "
194260|NCT00382109|"     This randomized phase III trial is studying tacrolimus, methotrexate, and sirolimus to see     how well they work compared to tacrolimus and methotrexate in preventing graft-versus-host     disease in young patients who are undergoing donor stem cell transplant for intermediate-risk     or high-risk acute lymphoblastic leukemia in second complete remission and high risk acute     lymphoblastic leukemia in first remission. Giving chemotherapy, such as thiotepa and     cyclophosphamide, and total-body irradiation before a donor stem cell transplant helps stop     the growth of cancer cells. It also helps stop the patient's immune system from rejecting the     donor's stem cells. The donated stem cells may replace the patient's immune cells and help     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     tacrolimus, methotrexate, and sirolimus after the transplant may stop this from happening. It     is not yet known whether tacrolimus and methotrexate are more effective with or without     sirolimus in preventing graft-versus-host disease.   "
194261|NCT00382122|"     Demographic information and a brief medical and concomitant medicine history will be obtained     from the glaucoma patient's records. Qualified patients will be asked to complete a     questionnaire about their symptoms. Patients will then be scheduled to undergo three standard     clinical tests of the ocular surface.   "
194262|NCT00382135|"     This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel     design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with     20 mg tadalafil.   "
194263|NCT00382148|"     This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control     (placebo) subjects who have completed their final visit (or early termination visit, if     applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who     provide consent to participate in this study.   "
194264|NCT00382161|"     The purpose of the study is to determine the effect of fluvastatin on penile arterial blood     flow and erectile function in patients with arteriogenic ED and cardiovascular risk factors.   "
194265|NCT00382174|"     The purpose of this study is to evaluate the safety, tolerability and effectiveness of     Thymosin Beta 4 administered topically in patients with Pressure Ulcers   "
194399|NCT00389896|"     The purpose of this study is to see how well simvastatin raises HDL levels in patients with     Type 2 Diabetes.   "
194267|NCT00382200|"     RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the     growth of myelodysplastic cells, either by killing the cells or by stopping them from     dividing. Tretinoin and decitabine may help myelodysplastic cells become more like normal     cells, and to grow and spread more slowly. Giving decitabine together with tretinoin may be     an effective treatment for myelodysplastic syndromes.      PURPOSE: This phase I/II trial is studying the side effects and best dose of tretinoin when     given together with decitabine in treating patients with myelodysplastic syndromes.   "
194268|NCT00388063|"     This study will evaluate the safety and efficacy of atiprimod treatment in patients with low     to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable     local-regional cancer and who have either symptoms (diarrhea, flushing and/or wheezing)     despite standard therapy (octreotide) or progression of neuroendocrine tumor(s).   "
194269|NCT00388076|"     Pazopanib will be given with TAXOL in one part, in another part pazopanib will be given with     TAXOL and PARAPLATIN, and in a third part pazopanib will be given with TAXOL and lapatinib     (patients separated in each part). Toxicity monitoring will enable us to find the largest     dose of pazopanib daily that can be safely given in combination with the chemotherapy agents     TAXOL and PARAPLATIN, and with lapatinib, as well as what side effects are likely to manifest     when these agents are given together and whether the combination of pazopanib with     chemotherapy, helps to treat different types of cancer. Another objective is to find out how     much pazopanib, TAXOL, PARAPLATIN and lapatinib are in the blood at specific times after the     agents are given. Collecting the blood samples requires that the patients remain in the     vicinity of the clinic overnight on 2 occasions.   "
194270|NCT00388089|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as topotecan, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving bortezomib together with topotecan may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and     topotecan in treating patients with advanced solid tumors.   "
194271|NCT00388115|"     RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor     cells. Giving radiofrequency ablation before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed.      PURPOSE: This clinical trial is studying how well radiofrequency ablation followed by surgery     works in treating patients with early invasive breast cancer or ductal carcinoma in situ.   "
194272|NCT00388128|"     The purpose of this study is to evaluate the change in Walking capacity after an intake of     caffeine. The study design is cross-over and follow-up of 80 patients with leg pain caused by     narrowing of their leg arteries, Peripheral Vascular Disease (PAD), stage II. Half of all     will be revascularised, follow up will be after 3 months. It is hypothesized that caffeine     (6mg/kg) can be a cheap, safe drug before walking exercise. Primary endpoint is maximum     walking distance (MWD), treadmill-testing,(constant load, 0%,2m/h). Secondary endpoints are     pain free walking distance (PWD), maximum muscle strength, endurance, reaction speed,     balance, cognitive function, health related quality of life (SF-36).   "
194273|NCT00388141|"     The purpose of this study is to determine whether systematic use of the Newborn     Individualized Developmental Care Assessment Program (NIDCAP®) improves the neurologic     development of children and the parental competence of mothers.   "
194274|NCT00388154|"     Primary Objective:        -  To estimate the antitumor activity of the combination of gemcitabine and cisplatin in          patients with advanced (stage III or IV) or recurrent endometrial cancer.      Secondary Objective:        -  To determine the nature and degree of toxicity of the combination of gemcitabine and          cisplatin in this cohort of patients.   "
194275|NCT00388167|"     We wanted to determine the efficacy and the safety of caspofungin acetate (CANCIDAS®) in the     treatment of invader fungal infection (IFI) specifically, Invasive Candidiasis (CI) in adults     patients without neutropenia and Invasive Aspergillosis (AI) in adults patients who are     refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of     amphotericin B, and/or itraconazole).   "
194276|NCT00388180|"     The investigational drugs administered in this study activate proteins called PPARs. Data in     the scientific literature on PPARs, as well as animal data and early clinical data generated     by GSK with these drugs, suggest that activation of PPARs may cause the body to increase its     use of fatty acids for energy, and lead to a reduction in body fat. There are also data to     suggest a role for PPARs in regulating lipid (e.g., cholesterol) levels and inflammation.     These and other activities of PPARs are being further explored in this clinical study.   "
194277|NCT00388193|"     The purpose of this clinical trial is to prove the efficacy of the following new regimen     treatment:        -  Administration of anti-CD20 (Rituximab) combined with chemotherapy.        -  Combined treatment with high doses of methotrexate and high doses of cytarabine with          conventional cytostatics (block C)        -  Prophylactic administration of G-CSF after all chemotherapy cycles        -  local irradiation after 6 cycle if CNS was affected or if there are residual tumour   "
194291|NCT00388375|"     The purpose of this study is to determine if emergency room physicians can use bedside     ultrasound to quickly determine the proper placement of a central venous catheter and to     evaluate for complications such as a punctured lung.   "
194278|NCT00388206|"     This is an observational study designed to follow patients with metastatic or locally     advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant     squamous histology) who are receiving Avastin in combination with first-line chemotherapy.     Second-line metastatic CRC patients are also eligible. Patients who started their Avastin     containing therapy <4 months prior to enrollment are eligible.   "
194279|NCT00388219|"     The purpose of this study is to determine whether Transtec (R) PRO 70 µg/h and a new     buprenorphine patch formulation lead to same plasma levels of buprenorphine after single dose     application   "
194280|NCT00388232|"     The study was designed to obtain some baseline data on COPD in Malatya region of Turkey.   "
194357|NCT00389324|"     This study will compare the blood level of Gamunex in patients. Patients will take it as an     injection under the skin or in a vein. The study will compare how safe and tolerable the two     methods are in the patients. The patients in this study have a defect in their immune system     from a genetic cause.   "
194281|NCT00388245|"     REHEAT 2 study is designed as a prospective, randomised trial comparing two strategies of     myocardial revascularisation (PCI vs CABG) in patients with ischemic cardiomyopathy and low     left ventricular ejection fraction.Patients will undergo in random way PCI or CABG procedure.     The aim the study is to assess the improvement of left ventricle systolic function and     comparing recent (30 days) and late (12 months) results of surgical (CABG) and percutaneous     (PCI) revascularization.   "
194282|NCT00388258|"     Patients undergoing major abdominal surgery are at highest risk for developing postoperative     ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal     distention, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or     inability to pass flatus or stool; and inability to tolerate a solid diet. This study will     test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of     surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery     (bowel resection or abdominal hysterectomy).   "
194283|NCT00388271|"     Urinary tract stones may form in the kidneys or along the ureteric tracts and when left     untreated, may result in complications such as pain, bleeding, infection and obstruction.     ESWL (extra-corporeal shock wave lithotripsy) has been shown to be an effective and safe     method of treatment for kidney and ureteric stones in-situ. In our centre, ESWL is done on an     outpatient basis with oral pain killers in the weeks following treatment. Patients are also     instructed to increase their fluid intake during this period to expedite the clearance of     stone fragments. There have been studies to show that pain caused by stones is due to smooth     muscle spasm along the ureters, possibly mediated by alpha-receptors. Alpha-blockers have     been shown to improve the expulsion of stones and also improve pain relief when used alone,     or together with ESWL treatment. In our study, we seek to investigate if alpha-blocker     therapy (Alfuzosin) increases stone free rates and improves pain control after ESWL for renal     and ureteric stones. The potential benefits include a higher rate of stone clearance and     better pain control   "
194284|NCT00388284|"     This trial is designed as a prospective, multi-center, randomized, double blinded clinical     trial to evaluate the safety and efficacy of the Thrombin VSI. An immunological sub-study to     assess antibody and coagulation changes in the subjects following exposure to the Vascular     Solutions Diagnostic Duett Pro manufactured with Thrombin VSI and Thrombin JMI will be     conducted as a component of this trial with a subset of the enrolled study subjects.      Two hundred seventy (270) subjects will be enrolled in this trial. A minimum of 50% of the     subjects will be interventional subjects and up to 50% will be diagnostic subjects. All 270     subjects will provide blood specimens at baseline and at the 30 day follow-up visit for     evaluation in the immunologic sub-study. Within the 270 subjects enrolled, a minimum of 45     subjects treated with the Thrombin VSI and a minimum of 45 subjects treated with the Thrombin     JMI will provide blood specimens at the 60 day follow-up visit to be evaluated in the     immunologic sub-study.      The primary efficacy objective is to demonstrate that the device time-to-hemostasis for the     study group treated with the sealing device manufactured with Thrombin VSI is non-inferior to     the study group treated with the sealing device manufactured with Thrombin JMI.      The primary safety objective is to demonstrate a device-related major complication rate for     the study group treated with the sealing device manufactured with Thrombin VSI that is     non-inferior to the device-related major complication rate observed for the study group     treated with the sealing device manufactured with Thrombin JMI.   "
194285|NCT00388297|"     The purpose of this study is to determine whether treating women, who are diagnosed with a     mild imbalance of thyroid hormones during pregnancy, with thyroid hormone replacement affects     their children's intellectual development at 5 years of age.   "
194286|NCT00388310|"     To evaluate the effective duration (in days) to clinical improvement of outpatient antibiotic     regimens in the treatment of superficial abscesses caused by MRSA in patients that present to     the emergency department.   "
194287|NCT00388323|"     The histological characteristics of alcoholic liver disease (ALD) and non-alcoholic     steatohepatitis (NASH) related to overweight and obesity suggest the presence of partly     common physiopathological mechanisms. We reported that the ponderal overload was an     independent risk factor of alcoholic cirrhosis. The adipose tissue was considered for a long     time as a simple place of storage of fat. However, it is now recognized that the adipose     tissue can secrete cytokines called ADIPOKINES.      The adipose tissue can secrete others cytokines such as TNF-alpha, IL6, IL10 and IL1-Ra.     Increase in the production of the leptin and TNF-alpha by the adipose tissue after alcohol     administration in the rat, as well as the role of leptin in inflammation and liver     fibrogenesis in the murine model of chemical hepatotoxicity strongly suggest that activation     of adipocytes by alcohol can explain the strong correlation observed between the body mass     index (BMI) and the severity of ethanol-induced liver injury. Conversely, it was suggested in     a murine model that the reduction in adiponectin production would sensitize the liver with     the toxicity of alcohol. The PPAR alpha and gamma are the receptors which play a role both in     inflammation and glucide and lipid metabolism. Taking into account the inhibiting role of     PPAR alpha on the proliferation of the hepatic stellate cells, responsible for the fibrosis,     the PPAR could also be implied in the relation between the overweight and the hepatic     fibrosis in the alcoholic.   "
194288|NCT00388336|"     The purpose of this study is to evaluate the effectiveness and safety of Epoetin alfa     administered at 60,000 Units every two weeks in cancer patients who are not receiving     chemotherapy or radiation therapy.   "
194289|NCT00388349|"     This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood     stem cell (PBSC) rescue for Hodgkin's Disease   "
194292|NCT00388388|"     This randomized, double-blind, parallel group, two-centre pilot study will test the     hypothesis that subjects who are otherwise healthy but fulfill the criteria for a diagnosis     of pre-hypertension and pre-diabetes will have regression or reduced progression of     hypertension-associated changes in their resistance arteries if their blood pressure is     controlled for 6 months with losartan, whereas similar subjects whose blood pressure is     equally well controlled using hydrochlorothiazide will have significantly less improvement of     the changes in their resistance arteries.   "
194426|NCT00390260|"     Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with     acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.   "
194293|NCT00388401|"     Patients undergoing major abdominal surgery are at highest risk for developing postoperative     ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal     distention, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or     inability to pass flatus or stool; and inability to tolerate a solid diet. This study will     test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of     surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery     (bowel resection or abdominal hysterectomy).   "
194294|NCT00388505|"     This study compares the safety of the tobramycin solution for inhalation with the tobramycin     dry powder formulation, used with a simple inhaler   "
194295|NCT00388518|"     This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of     aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6     treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active     comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po     daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on     study treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
194296|NCT00388531|"     The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.   "
194297|NCT00388544|"     Many persons with dementia exhibit behaviors that caregivers find difficult to manage. The     purpose of this study is to test the effectiveness of individualized recreational activities     for reducing agitation and passivity in persons with dementia.   "
194298|NCT00388557|"     The purpose of the study is to test how ketoconazole affects with handling of vinflunine by     the body which might affect how much vinflunine is in the blood stream and for how long   "
194299|NCT00388570|"     The purpose of this study is to demonstrate substantial equivalence between two medical     devices which measure nitric oxide in exhaled breath, NIOX MINO® and NIOX® in Symptomatic     Asthmatic Adults and Children.   "
194300|NCT00388583|"     As a result of the safety and immunogenicity data generated from earlier dose-ranging     studies, the present formulation has been selected for further development in the elderly.      Primary Objective:      To compare the immunogenicity in subjects receiving investigational Fluzone with those of     subjects receiving standard Fluzone®.      Secondary Objectives:      Immunogenicity:      To describe the immunogenicity in subjects receiving investigational Fluzone and standard     Fluzone®.      Safety:      To evaluate and describe the safety profile of investigational Fluzone in terms of solicited-     and unsolicited adverse events and serious adverse events post-vaccination.   "
194301|NCT00388596|"     The first purpose of this study is to determine if taking SB-751689 along with Rosuvastatin     (CRESTOR) or Atorvastatin (LIPITOR) will change how Rosuvastatin or Atorvastatin are absorbed     and eliminated from the body. Rosuvastatin and Atorvastatin are prescription medications used     to treat patients with high cholesterol. Patients who would take SB-751689 for osteoporosis     might also take Rosuvastatin or Atorvastatin for high cholesterol. In an earlier study,     SB-751689 was shown to lower the blood levels of Rosuvastatin when the two drugs were taken     at the same time. Lower blood levels of Rosuvastatin could mean that it would not be as     effective in lowering cholesterol. In this study SB-751689 will be taken alone, Rosuvastatin     will be taken alone, SB-751689 and Rosuvastatin will be taken together, and SB-751689 will be     taken 12 hours before Rosuvastatin is taken. This study will help determine if the two drugs     should be taken 12 hour apart to prevent lower Rosuvastatin blood levels. Atorvastatin will     be taken alone and at the same time as SB-751689 to determine if Atorvastatin blood levels     are lower when taken at the same time as SB-751689.      A second purpose of this study is to determine if taking another drug called Ketoconazole     (Nizoral) along with SB-751689 will change how SB-751689 is absorbed and eliminated from the     body. Ketoconazole is a prescription medication used to treat patients with fungal and yeast     infections.   "
194302|NCT00388609|"     The purpose of this study is to learn if BMS-646256 can cause weight loss in men and women     who are:        -  overweight with high blood pressure or high cholesterol or        -  obese      The safety of this treatment will also be studied   "
194303|NCT00388622|"     The aims of this randomized, clinical trial are to develop and test a multileveled     pharmacy-based program to improve the care of patients with heart failure. Risk factors for     deterioration of heart failure will be determined including poor adherence to medication.   "
194304|NCT00388635|"     This protocol is planned as a multicentric, national, open-label trial designed to evaluate,     first, optimal dose of Velcade® (Bortezomib) in combination with melphalan and prednisone.     After optimal dose is known, the second aim is evaluate safety and tolerance of V-MP plan, in     respond terms, in a cohort of 60 patients. Finally, the entire results will be compared with     those obtained from a series of 100 patients, all of them over 70 years old, diagnosed of     Multiple Myeloma belonging to the GEM protocol finished in May 2003   "
194314|NCT00388765|"     This study is designed to collect lung washing samples and small pieces of tissue (biopsies)     from the lungs of people who do not have any allergies or asthma. These samples will be used     by researchers in the future as control samples to compare to samples from people with     chronic lung diseases such as allergic asthma or emphysema. Control samples are samples are     very important in laboratory experiments so that the researchers can tell what may be labeled     as different or abnormal in samples from people with lung disease.   "
194315|NCT00388778|"     The purpose of this study is to compare the safety and efficacy of twice daily     subantimicrobial dose doxycycline 20mg with daily doxycycline 100mg in treatment of mild and     moderate Acne.   "
194522|NCT00391040|"     It was the aim of the study to develop and evaluate the effectiveness of a new structured     teaching and training programme for elderly patients with diabetes mellitus (SGS) and insulin     therapy.   "
194316|NCT00388791|"     The purpose of this study is to compare the efficacy of Systane Free to Saline in decreasing     the symptoms of dry eye after aggressive therapy. As a principal outcome measure, we are     using the modified Schein dry eye symptomatology questionaire to determine whether any     improvement in signs is mirrored by improvement in the Schein Score. Up to 30 dry eye     subjects will be dosed six times per day for one month. The typical clinical signs will be     onmitored (e.g., corneal staining) along with dyrness symptoms. The hypothesis is that an     optimized drop, Systane Free, will be more effective than saline solution in improving dry     eye signs and symptoms.   "
194305|NCT00388648|"     There are no solid data on the real advantage of an early start of dialysis, as suggested by     the DOQI guidelines. Uremic patients frequently have a poor nutritional status. However, we     cannot distinguish between the detrimental effect on nutrition of too low a residual renal     function or too long a period of low protein-diet, per se. However, it appears that a     very-low-protein diet (VLPD) supplemented with essential amino acids and keto-analogs of     amino acids, and with an adequate quantity of calories, can prevent hypoalbuminemia at the     start of dialysis and can slow the progression of chronic renal failure.      EDTA and USRDS data suggest that most patients starting dialysis nowadays are elderly, who     also have the highest incidence of morbidity and mortality. Moreover, hospitalization rate     becomes higher after the start of dialysis compared to the pre-dialysis period.      Can an aminoacid-supplemented VLPD, prolonged beyond the GFR limits suggested by DOQI, offer     elderly patients better survival and better quality of life than dialysis? The answer can     only come from a prospective, randomized trial, in elderly patients, starting at the GFR     values suggested by the NKF-DOQI for starting dialysis, comparing outcomes with a vegetarian     VLPD supplemented with a mixture of keto-analogs of amino acids and essential amino acids,     and with dialysis.   "
194306|NCT00388661|"     Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis     patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For     a good regulation of these circadian rhythms a uniform external synchronisation is necessary.     This is the synchronisation of the biological clock of our body by light and other     influences. In case of a disturbance of the external synchronisation, due to for example naps     during the day or wake periods at night, internal rhythms can be unlinked. As a result a     weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis     patients have sleep problems. Their sleep latency is prolonged. They often take a nap during     the day and their sleep efficiency is poor. There has only been one study on the melatonin     rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of     dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this     study no link was made between melatonin rhythm and the nature and severity of possible sleep     problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm,     exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal     biological clock and a better quality of life.      The aim is to improve quality of life of hemodialysis patients with a placebo-controlled     study with melatonin to investigate if exogenous melatonin can improve sleep problems and on     the longer term improve quality of life (and secondary morbidity) of dialysis patients.   "
194307|NCT00388674|"     The purpose of this study is to prospectively assess the long-term outcomes (benefits and     risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for     the treatment of chronic HBV infection. For the China substudy, patients randomized to     entecavir will have safety and efficacy assessments performed during the first year of the     study.   "
194308|NCT00388687|"     The aim of this study is to visualize the tumor hypoxic tissue, the potential quantitative     changes and the biological behavior of cervical carcinoma (primary and / or lymph nodes)     before, during and after radiochemotherapy with the novel hypoxia PET tracer 18FAZA.   "
194309|NCT00388700|"     The purpose of this clinical trial is to determine whether the combination of 5-fluorouracil     (5-FU) plus a DAVANAT (carbohydrate polymer) along with Avastin and Leucovorin (LV) is     beneficial in treating colorectal cancer in patients unable to tolerate intensive     chemotherapy.   "
194310|NCT00388713|"     Radiation induced accelerated atherosclerosis is a well known entity that occurs in different     regions, according to the therapy delivered.It is usually begins to be clinically evident     several years after the radiation incident, as there is sufficient functional reserve to     these vessels.Our proposal is aimed to better characterize this side effect. For that     purpose, we have chosen to study women who received radiation to the breast, in which part of     the carotid in the irradiated side was in the high energy radiation field. We will use Intima     Media Thickening ultrasound to study the pattern of atherosclerosis plaque formation in     radiated carotid arteries as compared to non-irradiated carotid arteries in women who are     receiving radiation therapy for breast cancer.   "
194311|NCT00388726|"     The purpose of this study is to compare Overall Survival (OS), Progression Free Survival     (PFS), objective tumor response rate, duration of response, and safety in patients treated     with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally     recurrent or metastatic breast cancer.   "
194312|NCT00388739|"     Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma     educational intervention in the pediatric Emergency Department (ED) with anti-inflammatory     medication will result in an improvement of ED revisits (and unscheduled return visits).     Chronic management intitiation in conjunction with an asthma educational intervention in the     pediatric ED with anti-inflammatory medication will also result in improved Quality of Life     measure.      Specific aims: 1. To demonstrate that the initiation controller medication therapy in     conjunction with asthma education will result in:        1. Decreased return ED visits (or unscheduled primary care physician visits) as compared to          a control group over a 12 month period        2. Improved Quality of Life as measured by Bukstein’s ITG Quality of Life measure.           2. To describe the relationship of the initiation of controller medication therapy in          conjunction with asthma education with well child visits, missed school/daycare days and          behavioral capabilities.           Objective: To determine the impact of beginning chronic asthma medication regimens after          an educational intervention in the ED in pediatric patients 1-18 years of age with mild          to moderate persistent asthma.           Long-term goal/purpose: To demonstrate the success of a model of care that utilizes the          emergency department physician to initiate National Asthma Education and Prevention          Program (NAEPP) guided chronic asthma therapy in children 1-18 years of age. This model          will attempt to bridge the gap in initiation of chronic asthma therapy currently left by          a failure of both emergency department and primary care physicians.   "
194313|NCT00388752|"     The purpose of this study is to identify the best treatment sequence and combination of     acupuncture points for the treatment of phantom limb or residual limb pain in the     traumatic/surgical amputee.   "
196096|NCT00413491|"     The purpose of the study is to determine whether MR of the breast is a better screening tool     than mammography combined with ultrasound of the breast in women with BRCA1 or BRCA2 gene     mutations.   "
194317|NCT00388804|"     Primary Objective:        -  To assess the possible improvement in prostate specific antigen (PSA) outcome of short          course androgen suppression therapy in conjunction with dose-escalation intensity          modulated radiation therapy (IMRT), 3D conformal radiation therapy (3D-CRT), or proton          therapy over IMRT, 3D-CRT, or proton therapy alone in prostate cancer patients          traditionally considered at intermediate risk for PSA failure following conventional          local therapy. PSA failure will be the primary endpoint.      Secondary Objectives:        -  To assess local control, freedom from distant metastasis, and overall survival.        -  To study the impact of radiation therapy and/or hormone therapy on health-related          quality of life measures using the Expanded Prostate Cancer Index Composite-Short Form          12-American Urological Association Symptom Index (EPIC-SF12-AUASI:          http://roadrunner.cancer.med.umich.edu/epic/).        -  To assess prognostic value of pretreatment serum testosterone as well as the decrease in          hemoglobin from neoadjuvant hormone therapy.        -  To assess prognostic value of pretreatment biomarkers on subsequent post-treatment          clinical outcomes.   "
194318|NCT00388817|"     The purpose of this trial is to determine whether minority and low-income patients with high     blood pressure take their medications better when they are helped by a pharmacist and     provided with special medication packaging and information aimed at persons with low health     literacy.   "
194319|NCT00388830|"     The purpose of this study is to determine whether fasting for 8 hours prior to     ultrasonography for cholelithiasis (gallbladder pain) is needed.   "
194320|NCT00388843|"     The purpose of the study is to determine if short term (6 months) treatment with statins to     lower low-density lipoprotein (LDL) in vascular disease patients with carotid plaque will be     associated with a measurable reduction in carotid plaque volume using 3 Tesla MRI. The     researchers will correlate the change in plaque volume to degree of LDL lowering. The     researchers will also study if brief treatment will lead to change in plaque composition. The     researchers will compare the change in plaque volume measured by 3T MRI with plaque burden     measured by ultrasound.   "
194321|NCT00388856|"     The purpose of this study is to investigate antioxidants supplementation in pregnant women     with low antioxidant status at 10-12 weeks gestation age in relation to adverse pregnancy     outcome in randomized prospective study.   "
194322|NCT00388869|"     CT of the abdomen is a very common examination performed for various indications.One of the     common findings is vascular calcifications including calcifications of the renal     arteries.Calcifications in the carotid arteries and coronary arteries are good predictor for     obstructive atherosclerotic disease.Stenosis of the renal arteries can cause symptomatic or     asymptomatic hypertension with subsequent clinical sequelae. Therefore early diagnosis of     this condition is imperative.      The goal of our study is to investigate the correlation between incidental calcifications of     the renal arteries in CT examinations and the presence of actual stenosis of these vessels in     patients with and without hypertension.   "
194323|NCT00388882|"     The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with     tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2     actuations qid in COPD patients currently prescribed Combivent® MDI.   "
194324|NCT00388895|"     % positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment   "
194325|NCT00388908|"     Osteoporosis is a common and progressive condition that leads to broken bones (fractures),     which cause pain, disability, deformity, and even death. There are new treatments available     that can decrease the risk of a fracture by 50%, and the people who benefit the most are     those with osteoporosis who have already had a fracture, like a vertebral (spine) fracture.     Vertebral fractures are usually silent, and ~20% of people over the age of 60 years have     had one although they don't know it. Many of these people have had chest x-rays done for     other reasons, and these x-rays can incidentally detect these silent fractures. Although most     people with a vertebral fracture should be tested and treated for osteoporosis, studies     demonstrate that less than one-quarter of older people with a vertebral fracture are ever     investigated or even treated. This reflects a gap between evidence-based best practice and     everyday practice in the community. The proposed research addresses this care-gap by using a     quality improvement intervention that uses chest x-rays done in the Emergency Department to     remind family physicians about osteoporosis while providing them with evidence-based     treatment guidelines - with or without educating and empowering patients about osteoporosis.     The effectiveness of this intervention will be compared to usual care in a controlled trial.     The intent of this research is to improve quality of care for patients at high risk of     fracture, by increasing rates of testing and treatment of osteoporosis.   "
194342|NCT00389129|"     Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It     has been speculated that these patients might be resistant to aspirin, and studies have     indicated that this phenomenon is related to a less favourable prognosis. At present, no     international consensus exists on how to measure aspirin resistance. The purpose of this     study is to compare different methods for detecting aspirin resistance. A classic but     cumbersome way of evaluating platelet function will be compared to newer, easy-handling     point-of-care tests. We hypothesize that one or more point-of-care tests will prove to be     superior to the classic platelet function test in detecting aspirin resistance.   "
194343|NCT00389142|"     Interstitial cystitis (IC), also called painful bladder syndrome (PBS), or chronic pelvic     pain syndrome(CPPS) is a common condition with no known cause or cure. Twin studies and     family accounts have suggested that the condition may be genetic or passed down (inherited)     from one generation to another.      In this study, we are collecting genetic material and medical information from families in     North America in an attempt to identify genetic factors that may cause IC/PBS/CPPS. We are     enrolling families and individuals with IC/PBS/CPPS and their family members (both family     members with and without IC like symptoms).   "
194344|NCT00389155|"     The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in     combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be     treated with cisplatin. This study will help to determine whether vinflunine in combination     with gemcitabine will extend the time period until further growth of the tumor more than     gemcitabine alone.   "
194326|NCT00388921|"     Vitamin A deficiency is an important health problem globally including Bangladesh. The     problem is greater among under-five children, particularly in malnourished. Vitamin A     supplementation reduces morbidity from diarrhoeal diseases and also prevents future diarrhoea     episodes. However, there are conflicting reports on the role of vitamin A supplementation on     morbidity from acute lower respiratory infections (ALRI) including pneumonia. In     non-malnourished children supplementation has been reported to be associated with increased     incidence and morbidity of ALRI. The WHO committee[1] has reviewed both the risk and benefit     of mega dose (200,000 IU) vitamin A supplementation during acute illness particularly     diarrhoea, irrespective of the nutritional status of under-5 children and recommended vitamin     A supplementation in areas where vitamin A status is low. In Bangladesh mega dose (200,000     IU) of vitamin A is routinely supplemented to under-5 children every 6 months. Absorption of     vitamin A precursors from the GI tract is reduced in severely malnourished children, who are     also lacking in retinol binding protein (RBP), required for transportation of retinol to     target tissues. Thus it is established that a significant portion of the supplemented vitamin     A is excreted in feces and urine of malnourished children. The excretion of vitamin A     increases substantially during acute infections including diarrhoeal diseases. On the other     hand, due to reduced RBP, concentration of free vitamin A increases in the body resulting in     the possibility of adverse events including “pseudotumor cerebri”. It has recently been     observed that low-dose daily supplementation of vitamin A to malnourished children produces a     better effect on recovery from acute illness and also in preventing infectious diseases among     under-five children. However, the limitations of those studies included a small sample size,     delayed assessment of retinol after supplementation among the others. Thus WHO felt that the     issue needs to be addressed in a well-designed clinical trial. We hope that our proposed     study will enable us to compare the efficacy of low-dose daily administration of vitamin A     with that of initial mega dose followed by daily low dose of vitamin A in malnourished     children presenting with acute diarrhoeal diseases with or without ALRI. If the results of     this study indicate that the daily low-dose has similar efficacy to that of the currently     recommended mega dose followed by daily low-dose of vitamin A, would have important     programmatic implications.   "
194327|NCT00388934|"     Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express)     and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery     disease.   "
194328|NCT00388947|"     This registry was observational (only collected information typically noted by the surgeon     when their patients were routinely seen); there was no change to the care the patient     received as a result of being part of the registry). Data collection focused on the surgical     outcomes of AMS prolapse products.   "
194329|NCT00388960|"     The purpose of the study is to document the activity and safety of single agent amrubicin,     amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line     treatment in extensive disease small cell lung cancer.   "
194330|NCT00388973|"     The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR)     quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve     depressive symptoms in elderly patients with major depressive disorder.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
194331|NCT00388986|"     This study will assess the potential pharmacodynamic and potential pharmacokinetic     interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not     adequately controlled with glyburide as standard prescribed therapy. Patients will enter the     study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK     Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK     Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and     glyburide treatment re-started. The anticipated time on study treatment is <3 months, and the     target sample size is <100 individuals.   "
194332|NCT00388999|"     MBL deficient patients enrolled in this protocol are scheduled to be treated with     melphalan-based high-dose chemotherapy followed by autologous hematopoietic stem cell     transplant (HSCT) for their multiple myeloma. Patients are randomized to 0.5 mg/kg, 1.0     mg/kg, or no rhMBL.   "
194333|NCT00389012|"     The purpose of this study is to determine if treadmill training with body weight-support     (BWST) is more effective at improving walking in individuals post-stroke than a resisted     leg-cycling exercise program. In addition, we want to determine if training programs that     combine leg strength training to treadmill walking provide an additional benefit to     post-stroke walking outcomes.   "
194334|NCT00389025|"     To assess the effects of olopatadine of the release of mast cell histamine   "
194335|NCT00389038|"     The purpose of this trial is to evaluate the efficacy of combined behavioral and     pharmacological treatment on chronic daily headache in children ages 10 to 17.   "
194336|NCT00389051|"     The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor     effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell     Non-Hodgkin's Lymphoma.   "
194337|NCT00389064|"     The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR)     quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve     elderly patients with generalised anxiety disorder.      PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The     SR designation was changed to XR after consultation with FDA.   "
194338|NCT00389077|"     This is a study of the drug perifosine for patients who have no standard treatment options.     This study is designed to identify which cancer types respond to perifosine, and determine     which regimen of perifosine is most effective in each one. Patients with either solid tumors     or with lymphomas for whom this protocol represents reasonable or optimal treatment will be     randomized to receive either perifosine 100 mg daily or 900 mg weekly until disease     progression. Based on currently available data it is anticipated that these doses should be     easily tolerated by most patients.   "
194339|NCT00389090|"     This is an open-label, multicenter, phase II trial, assessing the antitumor activity, and     safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant     anaplastic glioma.   "
194340|NCT00389103|"     purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine     injections in healthy adults that are 18-35 years of age with a history of mild to moderate     Atopic Dermatitis.   "
194341|NCT00389116|"     Small bowel obstructions are responsible for 2 to 5% of emergency hospital admissions and 20%     of all emergency surgical procedures. In 60 to 80% of cases, acute small bowel obstructions     are the consequence of intraperitoneal postoperative adhesions. They constitute an extremely     frequent pathology, leading to a high rate of hospital admissions and money expense.      Management of small bowel obstruction is based on 2 options: either a surgical approach where     all patients are operating on, or a conservative treatment in which surgery is proposed in     case of failure of medical treatment. The surgical approach leads to operate on an excessive     rate of patients while the medical approach increases the risk of increased small bowel     resection, morbidity rate or hospitalization duration.      In order to improve the management of small bowel obstruction, it seems necessary to better     distinguish patients that need an emergency surgical procedure from patients in which medical     treatment will be useful. Many studies have been performed to investigate the value of     imaging in the management of small bowel obstruction, using abdominal X-ray, oral     gastrografin administration or CT-Scan.      The aim of this study is to analyse the effect of a systematic performance of imaging     investigation on the management of patients presenting with a postoperative small bowel     obstruction.      All patients suffering from a postoperative small bowel obstruction will be included in this     study. They will be randomised in 2 groups. In group S, patients will have CT-Scan and oral     water administration while in group SG, Patients will have CT-Scan and oral gastrografin     administration The major end point of this study is to analyse whether imaging examination     can reduce the need for a surgical approach or the rate of small bowel resection and to     determine its influence on fasting time or hospitalization duration   "
194345|NCT00389168|"     The renin-angiotensin-aldosterone system has been implicated in the control of structural     changes of the heart and the vasculature, beyond the effects on blood pressure.      This projects examines the importance of the renin-angiotensin-aldosterone system and the     sympathetic nervous system in the control of cardiac and vascular structure and function in     subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were     randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48     weeks. Repeat investigations of blood pressure, structure and function of the heart and the     vascular tree, and neurohormones were performed. Two control groups, consisting of     normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also     examined for comparison.   "
194346|NCT00389181|"     The purpose of this study is to determine if medical management is better than invasive     therapy for improving the long-term outcome of patients with unruptured brain arteriovenous     malformations.   "
194347|NCT00389194|"     The main objective of the study is to assess changes in fat distribution over 48 weeks of     treatment in patients who currently successfully use zidovudine (AZT) and lamivudine (3TC) as     part of their regimen and who will either continue these antiretrovirals or who will switch     these antiretrovirals to tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Each of     these medications is commonly used for the treatment of HIV-1 infection.   "
194348|NCT00389207|"     Primary purpose of this study is to compare the efficacy and safety of two different     nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and     of atazanavir/ritonavir (Reyataz/Norvir), all on an emtricitabine/tenofovir disoproxil     fumarate (DF) (Truvada) background. Patients will receive either nevirapine (NVP) 200 mg     twice daily, or NVP 400 mg once daily , or ritonavir-boosted atazanavir (ATZ/r), all in     combination with emtricitabine (FTC) and tenofovir DF (TDF).      All patients receiving NVP will start at 200 mg once daily for 2 weeks, because it has been     demonstrated that this lead-in dosing regimen reduces the frequency of NVP-induced rash. At     Visit 3 (Week 2), patients increase the NVP dose to either 200 mg twice daily or to 400 mg     once daily. Patients receiving ATZ/r will be treated with ATZ 300 mg once daily, boosted by     100 mg ritonavir (RTV) once daily. Background antiretroviral therapy for all patients     consists of one tablet of Truvada. Treatment duration is 48 weeks (primary endpoint) with an     extension to 144 weeks. Patients may also participate in the metabolic sub-study, comparing     NVP and ATZ/r for signs and symptoms of lipodystrophy and serum lipid/glycaemic     abnormalities.   "
194349|NCT00389220|"     The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system     with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.   "
194350|NCT00389233|"     The study was carried out as a randomised, single-blind, active-controlled, multi-centric,     phase III study with two parallel treatment groups. The primary efficacy criterion was the     frequency of effective gut cleansing in each of the two treatment groups (grade A or B     overall quality of gut cleansing as judged by a blinded expert panel on the basis of     videotapes recorded during the endoscopic procedure).   "
194351|NCT00389246|"     More than 1,000 obese people are screened for genetic mutations (MC4R). Those with positive     screenings as well as 320 randomly selected people without MC4R mutations are randomized to 2     consultation types: one including recommendations for eating and physical activity behavior,     the other with an additional part on genetic determinants and actions in obesity. It is     hypothesized that obese people with obesity-specific genetic mutations, and obese people with     a family history of obesity, benefit more if the consultation includes additional elements on     genetic determinants.   "
194352|NCT00389259|"     Organophosphate (OP) compounds are a major threat as chemical warfare agents or in terrorist     act. OPs are also the active ingredient of many insecticides. Ingestion of insecticides is a     common cause of death among people who commit suicide in developing countries. OPs poisoning     also frequently occurs after accidental exposure to agricultural OPs and in children as a     result of unintentional ingestion.      The use of competitive inhibitors of acetylcholine other than atropine for patient with     organophosphate (OP) poisoning is controversial. Because scopolamines' ability to cross the     blood brain barrier is better than atropine, it has been suggested that scopolamine should be     used OP poisoned patients who have central nervous system (CNS) manifestations. However there     is controversy regarding its potential benefit in the treatment of organophosphate poisoning     in humans. To the best of our knowledge there are no randomised controlled studies on the use     of scopolamine in humans. This prospective randomised controlled study is aimed to determine     whether adding scopolamine to the standard treatment of atropine and oximes in patients with     CNS symptoms of OP poisoning improve the outcome.   "
194353|NCT00389272|"     Fever is one of the most common symptoms in pediatrics and one of the most common reasons for     visits in pediatricians' office and pediatric emergency departments. Many parents consider     fever to be the most terrifying symptom.      Acetaminophen and ibuprofen are both effective and safe treatments for febrile children. In     order to achieve better temperature control and to avoid toxicity it has been suggested to     treat febrile children with alternating doses of acetaminophen and ibuprofen. Surveys in the     USA and Spain found that this practice is very common. However, The safety and efficacy of     such practice was never described.      Hypothesis:      Children who are still febrile after being treated with acetaminophen or ibuprofen will have     greater temperature decrement if treated with another drug (acetaminophen for those treated     with ibuprofen and ibuprofen for those treated with acetaminophen) than if treated with     placebo.   "
194354|NCT00389285|"     The purpose of the study is to evaluate whether recombinant IL-21 used in combination with     sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).   "
194372|NCT00389519|"     The primary purpose of this study is to evaluate the blood pressure lowering effects of     ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and     adolescents aged 6 to 16 years with hypertension.   "
194355|NCT00389298|"     The purpose of this study is to determine whether a 10-day course of therapy with orally     administered VCH-759 given at 400-mg, 600-mg or 800-mg three times daily can effectively     reduce the amount of circulating virus (i.e., viral load) in patients with early-stage     chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of     treatment with VCH-759. Blood samples will also be taken to measure the levels of VCH-759     present in plasma at various time points during the treatment period.   "
194358|NCT00389337|"     BACKGROUND: In November 2003 the Medical Director at Copenhagen University Hospital,     Hvidovre, gathered a group of doctors involved in the diagnosis and treatment of patients     with sepsis.      AMIS: To develop a fast and reliable tool that can guide the physician in the diagnosis and     treatment of the septic patient thereby reducing mortality and morbidity. The measurement of     markers of inflammation, coagulation, infection and specific bacterial antigens in the same     plasma sample will give insight to the pathogenesis of sepsis and SIRS and the bodies     responds to the disease.      MATERIAL AND METHODES: Case-Control study nested in cohort. 300 patients admitted to the     hospital from 1.01.05 to 01.07.06. Copenhagen University Hospital, Hvidovre, an 800 beds     hospital, covers a part of Copenhagen with a wide variety in the population's socioeconomic     and cultural background. For the analysis of markers the luminex 100 lab analysis system is     used. It utilizes xMAP® technology which enables you to simultaneously assay up to 100     analytes in a single well of a microtiter plate, using very small sample volumes. Assay     development of a 15-plex is don In-house.      COWORKERS & FOUNDING: The following departments at the hospital, are coworkers in the SPEEDI     study: Clinical Research Unit, Departments of Infectious Disease, Clinical Microbiology,     Clinical Biochemistry, Gastroenterology (incl. surgery), Intensive Care Unit, Emergency Room,     and the Hospital Board of Directors. All departments have research experience and a long     tradition of publication of scientific works. The study received founding for equipment and     salaries during the first phase of the study from the hospitals Board of Directors.     Applications to major public foundations in Denmark are awaiting answer. No commercial     interest are involved in the study.      FUTURE APPLICATIONS: A second phase of the study including children admitted at the hospital     is in preparation. The very small sample volume is a great advantage in diagnosing infection     in children. The applications of the study results will hopefully provide the physician with     the needed tool for a fast and reliable diagnosis, prognosis and treatment guide for the     patients suffering from SIRS and sepsis.   "
194359|NCT00389350|"     The objective of this study was to determine if taking an extract of green tea for three     months could improve glucose control in adults with diabetes.   "
194360|NCT00389363|"     The purpose of the trial is to determine if treatment of asthma patients allergic to house     dust mites with the ALK HDM tablet can reduce the need of inhaled corticosteroids (ICS).   "
194361|NCT00389376|"     The purpose of this study is to determine the safety and tolerability of different dosages of     silymarin on subjects with Hepatitis C or Non-Alcoholic Fatty Liver Disease.   "
194362|NCT00389389|"     The primary purpose of this study is to find out what the maximum tolerated dose is for an     experimental drug called AZD4877 based on the side effects experiences by patients that     receive AZD4877 on a weekly basis   "
194363|NCT00389402|"     The purpose of this study is to assess differences in changes in plasma lipids between     patients on saquinavir/ritonavir or atazanavir/ritonavir in combination with tenofovir     disoproxil fumarate and emtricitabine as a first-line regimen in patients previously naive     for antiretroviral therapy. This study is an extension from the SSAR 2004/0002 which     randomised patients over the same treatment arms.   "
194364|NCT00389415|"     This 52-week multicenter open-labeled extension study is designed to assess the long-term     safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is     open to patients who have completed core study CLAF237A1303.   "
194365|NCT00389428|"     The primary objective of this study is to determine the recommended dose of CPX-351 for use     in a phase 2 efficacy study in patients with leukemia. Secondarily, the study will assess the     safety, serious adverse effects and how the body handles CPX-351. Preliminary evidence of     antitumor activity will also be determined.   "
194366|NCT00389441|"     The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer     that is resistant to radioactive iodine   "
194367|NCT00389454|"     Acetaminophen is the most commonly used drug in children. Inhibition of COX-3 in the brain     has been suggested as the primary central mechanism by which acetaminophen decrease pain and     possibly fever. However there is very limited data about acetaminophen concentrations in the     brain and no such data is available for newborns. The objective of the current study is to     describe concentrations of acetaminophen in the fluid around the brain of infants after     administration of acetaminophen.   "
194368|NCT00389467|"     The purpose of this study is to compare the effectiveness of treating acute ischemic stroke     with mechanical embolectomy using the Merci Retriever or the Penumbra System within 8 hours     of symptom onset to standard medical treatment, and to identify people who might benefit from     mechanical embolectomy by the appearance of stroke on multimodal computerized tomography (CT)     or magnetic resonance (MR) imaging.   "
194369|NCT00389480|"     Hypothesis:      AR-67 (formerly DB-67) represents a rationally engineered drug that possesses improved     stability, toxicity, and efficacy compared to current Food and Drug Administration     (FDA)-approved camptothecins, based on the extensive research of prior studies. Therefore,     the investigators hypothesize that AR-67 (formerly DB-67) will be well-tolerated and     efficacious in phase I clinical trials. This initial phase I trial will establish the maximum     tolerated dose in humans, establish the toxicity profile, and define the appropriate dose of     AR-67 (formerly DB-67) for future phase II and III clinical trials.   "
194370|NCT00389493|"     This study will compare the short- and long-term effectiveness of two common therapies in     improving serotonin reuptake inhibitor treatment in people with obsessive-compulsive     disorder.   "
194371|NCT00389506|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. LMB-2 immunotoxin can find cancer cells and kill them without harming     normal cells. Giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin may kill     more cancer cells.      PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide     followed by LMB-2 immunotoxin works in treating patients with Hodgkin's lymphoma.   "
194373|NCT00389532|"     To submit remaining available sera to Center for Biologics Evaluation and Research (CBER) for     further analysis by the Food and Drug Administration (FDA), the Center for Disease Control     and Prevention (CDC) and the World Health Organization (WHO) to support selection and     recommendation of antigen strains for subsequent influenza vaccines.   "
194374|NCT00389545|"     Despite the widespread use of effective reperfusion therapies, the patients presenting late     with large myocardial infarction have poor outcomes. The aim of the study was to investigate     the safety and efficacy of intracoronary injection of autologous bone marrow-derived     mononuclear cells (BMNCs) in patients with large myocardial infarction   "
194375|NCT00389558|"     The purposes of the study are:        1. To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used          for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).        2. To evaluate whether the bacteria responsible for nosocomial infection is comparable to          the flora diagnosed at the EPI site.   "
194376|NCT00389584|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Irinotecan may make tumor     cells more sensitive to radiation therapy. Giving irinotecan together with whole-brain     radiation therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan when     given together with whole-brain radiation therapy and to see how well they work in treating     patients with brain metastases from solid tumors. (The study of side effects and best dose     has ended as of 4/15/05)   "
194377|NCT00389597|"     The purpose of this investigation is to establish the safety and effectiveness of the LDR     Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical     device. The primary objective of the study is to evaluate the overall success rate of the     investigational device as compared to the control in the treatment of patients with     symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels.     Patients should be without prior cervical fusion between C3 and C7 and unresponsive to     non-operative conservative treatment for six weeks after symptom onset or have the presence     of progressive symptoms or signs of nerve/spinal cord compression despite continued     non-operative conservative treatment.   "
194378|NCT00389610|"     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune     response to kill tumor cells. Giving booster vaccinations may make a stronger immune response     and prevent or delay the recurrence of pancreatic cancer.      PURPOSE: This phase II trial is studying the side effects and how well vaccine therapy works     in treating patients with pancreatic cancer that has been removed by surgery.   "
194379|NCT00389636|"     Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic     foot ulcer condition. The purpose of the study is provide the sponsor with pilot information     regarding the ability of TheraGauze to promote wound healing on its own and to examine     synergy with Regranex in the treatment of diabetic foot ulcers.   "
194380|NCT00389649|"     This will be a double blind randomized crossover study of patients with congestive heart     failure and a heart rate dependent upon a permanent pacemaker. Thus, at all times the heart     rate can be maintained at a set rate by adjusting the settings of the pacemaker. Acute and     chronic effects of heart rates of 60, 75, and 90 beats per minute will be evaluated. The     effect of heart rate will be determined by measuring ejection fraction by nuclear     ventriculography, six minute walk distance, and peak oxygen consumption on a maximal exercise     test.   "
194381|NCT00389662|"     To evaluate the effect of wearing the 'Nike Free'Shoe on isokinetic muscle strength of foot     and ankle and on proprioception the following protocol will be used.      The test population consists out of students of the physical education department. They will     at random be divided in three groups. One group will wear the shoe only for daily activities,     the second group will wear the shoes for the warming up part of the sport classes and the     control group will not wear the shoe at all. There will be two moments for evaluation: one at     the beginning of the study and one after four months, during which the shoe will be used. The     isokinetic strength will be measured with an isokinetic device (Biodex) and the     proprioception will be evaluated with a force platform (Neurocom Balance Master).   "
194382|NCT00389675|"     This is a double-blind, active-controlled, long-term study of a new experimental drug called     darusentan. Darusentan in not currently approved by the United States Food and Drug     Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of     this study is to evaluate the long-term safety of darusentan (optimized dose) as compared to     an active control, administered orally.   "
194383|NCT00389688|"     RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) before surgery may     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.     Giving combination chemotherapy after surgery may kill any tumor cells that remain after     surgery. It is not yet known whether combination chemotherapy is more effective before or     after surgery in treating non-small cell lung cancer.      PURPOSE: This randomized phase II trial is studying the side effects of pemetrexed disodium     and cisplatin and comparing how well they work when given before or after surgery in treating     patients with stage IB or stage II non-small cell lung cancer that can be removed by surgery.   "
194384|NCT00389701|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy,     such as dexamethasone, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving bortezomib together with     dexamethasone may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with     dexamethasone works in treating patients with multiple myeloma that has relapsed or has not     responded to treatment.   "
194413|NCT00390091|"     The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP     394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.   "
194718|NCT00393939|"     This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib     combined with docetaxel versus docetaxel, administered as first-line treatment, in patients     with unresectable locally recurrent or metastatic breast cancer.   "
194397|NCT00389870|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Cyclosporine may help irinotecan work better by making tumor cells more sensitive to the     drug. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known     whether irinotecan is more effective when given with or without panitumumab or cyclosporine     in treating colorectal cancer.      PURPOSE: This randomized phase III trial is studying irinotecan to compare how well it works     when given with or without panitumumab or cyclosporine in treating patients with advanced or     metastatic colorectal cancer that did not respond to fluorouracil.   "
194385|NCT00389714|"     Composite resins are presently among the most popular esthetic restorative materials in     dentistry. These materials offer excellent esthetic appearance, allow for conservative cavity     preparation and are now becoming widely accepted for clinical use in primary molars 1-23.     Despite the improvement of their properties, achieved with better materials and incremental     placing techniques, composite resin restorations appear to have still several drawbacks:     although similar to amalgam in short terms studies, they have a high long term failure rate,     mainly due to discoloration, loss of retention and secondary caries3,11,19, are     time-consuming and technique sensitive, lack anti-cariogenic potential and can be amenable to     secondary caries at the cervical dentin margins 1, 2.      Continued interest in providing advance in restorative esthetic materials led to the     development of new generations of composites. Among the newest material developed is the use     of minute amount of nanoparticles which convert composites to possess permanent antibacterial     properties.      It is of great interest to observe the clinical behavior of this new material when utilized     in clinical practice. Thus the aims of the present in-vivo study are:        1. To evaluate the clinical and radiographic performance of the New Restorative System when          placed with adhesive systems in class II restorations of primary molars.        2. To assess, by SEM, the micromorphology of the cervical, buccal and lingual margins of          the proximal surfaces of the restored teeth retrieved after exfoliation or extraction.        3. To asses, by means of polarized light microscopy, the integrity of the cervical margins          of the same retrieved teeth.   "
194386|NCT00389727|"     The objective of the study is to assess the feasibility of increasing dose of irradiation     with IMRT using a SIB approach over 6 weeks.      The primary endpoint of the study will be acute toxicity assessed during treatment and during     the first 3 months following the completion of radiotherapy The secondary endpoint will     include loco-regional control, disease-free survival, survival and late toxicity at 2 years     after completion of radiotherapy   "
194387|NCT00389740|"     The purpose of this study is to compare how well alendronate and raloxifene increase the bone     density in women who have osteoporosis and have experienced menopause.   "
194388|NCT00389753|"     Comparison between use of Aruba Aloë formula F-BC-096 and control.   "
194389|NCT00389766|"     RATIONALE: Radioisotope therapy, such as iodine I 131 metaiodobenzylguanidine (MIBG),     releases radiation that kills tumor cells. Drugs used in chemotherapy, such as topotecan,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Topotecan may also make tumor cells more sensitive to iodine I     131 MIBG. A peripheral stem cell transplant may be able to replace blood-forming cells that     were destroyed by iodine I 131 MIBG and topotecan. This may allow more iodine I 131 MIBG and     topotecan to be given so that more tumor cells are killed.      PURPOSE: This phase II trial is studying how well giving high-dose iodine I 131 MIBG together     with topotecan and peripheral stem cell transplant works in treating young patients with     relapsed stage 4 neuroblastoma or primary resistant high-risk neuroblastoma.   "
194390|NCT00389779|"     This is a randomized, double-blind, placebo- and active-controlled study of a new     experimental drug called darusentan. Darusentan is not currently approved by the United     States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this     drug. The purpose of this study is to determine if darusentan is effective in reducing     systolic and diastolic hypertension despite treatment with full doses of three or more     antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan     (optimized dose), an active comparator, or placebo, administered orally. The treatment period     for this trial is 14 weeks.   "
194391|NCT00389792|"     The purpose of this study is to determine the safety and efficacy of an investigational     antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a     dual chamber pacemaker.   "
194392|NCT00389805|"     RATIONALE: Bortezomib and pemetrexed disodium may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Giving bortezomib together with pemetrexed     disodium may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of two different     schedules of bortezomib when given together with pemetrexed disodium and to see how well they     work in treating patients with advanced non-small cell lung cancer or other solid tumors.   "
194393|NCT00389818|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as rituximab, can block cancer growth in different ways. Some find cancer cells and help     kill them or carry cancer-killing substances to them. Others interfere with the ability of     cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may     kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with rituximab works in treating patients with newly diagnosed AIDS-related B-cell     non-Hodgkin's lymphoma.   "
194394|NCT00389831|"     The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of     rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.   "
194395|NCT00389844|"     The major goals of this study are:      To implement a self-efficacy based intervention to strengthen efficacy beliefs related to     exercise, decrease perceived barriers to exercise, and increase exercise behavior and overall     activity of older women who have sustained a hip fracture.      To test the effectiveness of the Exercise Trainer component of the intervention on exercise     behavior, activity, efficacy expectations, barriers to exercise, performance behaviors,     overall health status, mood, pain, fear of falling, falls and fall-related injuries at 2, 6,     and 12 months following fracture.   "
194396|NCT00389857|"     To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from     healthy children receiving the 2006-2007 formulation of the inactivated, split-virion     influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA),     Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).   "
194453|NCT00390611|"     This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone     vs. standard chemotherapy plus sorafenib in patients with stage III/IV ovarian cancer     following cytoreductive surgery. Patients with residual large volume disease and/or bowel     involvement will be excluded, to minimize the risk of bowel perforation.   "
194400|NCT00389909|"     Doxapram is used to stimulate respiration. For a given dose, the fluctuations in     concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy     or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of     this study is to compare a dosage regimen based only on patient's weight, to another one     using a dosing chart taking into account weight, age and gender.   "
194401|NCT00389922|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving lapatinib together with vinorelbine may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when     given together with vinorelbine in treating patients with advanced solid tumors.   "
194402|NCT00389935|"     The purpose of this study is to determine whether Thalidomide is effective in the treatment     of arteriovenous malformations in the gastrointestinal tract.   "
194403|NCT00389948|"     Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic     stomach contents move into the esophagus from the stomach. This study will investigate the     safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.   "
194404|NCT00389974|"     This phase II trial studies the side effects and how well sunitinib malate works in treating     patients with cervical cancer which cannot be cured by standard therapy. Sunitinib malate may     stop the growth of cervical cancer by blocking some of the enzymes needed for cell growth and     by blocking blood flow to the tumor.   "
194405|NCT00389987|"     This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with     respect to the clinical response in baseline microbiologically evaluable patients; and to     evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.   "
194406|NCT00390000|"     RATIONALE: Vatalanib and pemetrexed disodium may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Vatalanib may also stop the growth of tumor cells     by blocking blood flow to the tumor. Giving vatalanib together with pemetrexed disodium may     kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib when     given together with pemetrexed disodium in treating patients with advanced solid tumors.   "
194407|NCT00390013|"     The purpose of this research study is to evaluate if the medication gabapentin lessens the     vulvar pain some women experience.   "
194408|NCT00390026|"     The object of the study is to compare the treatment effect of bevacizumab (Avastin), an     antibody targeting vascular endothelial growth factor, with verteporfin photodynamic therapy     (PDT) for patients with neovascular age-related macular degeneration, the leading cause of     vision severe loss in the Western world.   "
194409|NCT00390039|"     Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and     placebo-controlled study in patients with moderate to severe post-surgical pain from elective     orthopedic surgery with safety observed for a total of 30 hours post first dose.   "
194410|NCT00390052|"     This phase I trial is studying the side effects and best dose of 3-AP in treating patients     with advanced or metastatic solid tumors. 3-AP may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
194411|NCT00390065|"     Utilization of nitric oxide (NO) therapy has been related to a trend towards short term     improvement in very premature infants. A two year follow-up of children treated soon after     birth with NO in the neonatal period, suggests that a significant improvement in     neurodevelopmental outcome might occur. This study aims to evaluate follow-up at 6 years, in     respiratory and neurodevelopmental outcome, of children born very prematurely, some of them     having been treated with nitric oxide in the neonatal period.   "
194412|NCT00390078|"     At the end of 2004 there were more than 40 million people infected Worldwide with HIV, with     an estimated 16,000 new infections every day (UNAIDS, 2004). The HIV epidemic threatens whole     societies particularly in Africa and Asia and rates of infections in the Western Countries     have also increased over the last few years. However, despite more than 15 years of research,     an effective vaccine against HIV and acquired immunodeficiency syndrome (AIDS) has still not     been developed.      There is considerable evidence that cellular immune responses can effectively control HIV-1     replication during acute and chronic infections thereby possibly protecting individuals from     infection and preventing the spread of HIV. To be truly effective in the general population,     a vaccine must induce responses specific to immunologically conserved regions. The     epitope-based vaccine MVA-mBN32 represent a very logical approach to this problem because its     potential to elicit a polyfunctional immune response and to focus these responses to     conserved epitopes.      In this study the safety, tolerability and immunogenicity of a recombinant MVA-BN® expressing     CTL and HTL epitopes of HIV-1 (MVA-mBN32) vs. the vector control MVA-BN® in 30 HIV-infected     subjects will be examined. This will include a full analysis of CD4+ T helper cells and CD8+     CTL responses to these epitopes, to establish the potential of such a homologous prime-boost     vaccine approach to induce a broad cell-mediated response to different HIV antigens.   "
194414|NCT00390104|"     The purpose of this study is to identify genes and proteins responsible for nerve and muscle     disorders by studying genetic material from individuals with neuromuscular disease, as well     as their family members. We are interested in recruiting many types of neuromuscular disease     including; Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), and     limb-girdle muscle dystrophy (LGMD). There are still many patients diagnosed with muscular     dystrophy but have no causative gene implicated in their disease. We feel that these patients     may have new genetic changes in genes coding for important muscle proteins that we have yet     to identify. Using molecular genetics to unravel the biochemical basis of these neuromuscular     disorders should lead to more accurate diagnosis of these disorders and should lead to     potential therapies.   "
194415|NCT00390117|"     RATIONALE: AT7519M may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of AT7519M in treating     patients with advanced or metastatic solid tumors or refractory non-Hodgkin's lymphoma.   "
194416|NCT00390130|"     The objective of this study is to determine whether there should be a predetermined sequence     recommended for administering these two vaccines, with the less painful vaccine being given     first.   "
194417|NCT00390143|"     This study will investigate the long-term protection offered by GSK Biologicals'     meningococcal vaccine 134612 up to 3.5 years after vaccination. Subjects were vaccinated at     15 to 19 years of age. This extension phase starts 18 months after vaccination and part of     the subjects who were vaccinated in the primary study will be enrolled in this extension     phase. No new subjects will be enrolled. This protocol posting deals with objectives &     outcome measures of the extension phase 18, 30 and 42 months after vaccination. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT00126945). The Protocol Posting has been updated in order to comply with the FDA     Amendment Act, September 2007.   "
194418|NCT00390156|"     RATIONALE: Imatinib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Drugs used in     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Bevacizumab and     cyclophosphamide may also stop the growth of tumor cells by blocking blood flow to the tumor.     Imatinib and bevacizumab may help cyclophosphamide work better by making tumor cells more     sensitive to the drug. Giving cyclophosphamide once a day together with imatinib and     bevacizumab may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib when given     together with bevacizumab and cyclophosphamide in treating patients with refractory     metastatic solid tumors.   "
194419|NCT00390169|"     This study will compare three standard treatment programs commonly offered to patients with     breast cancer. The three programs being compared are 1) Mindfulness Meditation-Based Stress     Reduction (MBSR), 2)Supportive- Expressive Group Therapy (SET), and 3) A one day     stress-management seminar. The purpose of this study is to determine if these three     treatments have different effects on psychological well-being, the immune system, and the     amount of stress hormones in the bloodstream.   "
194420|NCT00390182|"     The purposes of this study are:        1. To assess the maximum tolerated dose of low-dose UART(Upper Abdominal Radiation Therapy          ) or WART(Whole Abdominal Radiation Therapy) given in combination with standard fixed          dose-rate Gemcitabine in patients with advanced gastrointestinal (GI) or ovarian tumors          (Phase I).        2. To assess response rate and survival in advanced upper GI tumors following completion of          therapy (Phase II).   "
194421|NCT00390195|"     The mTOR has been examined in hepatocellular carcinomas as well. This pathway is up-regulated     in a proportion of hepatocellular carcinoma (HCC) and that rapamycin inhibits cell     proliferation and blocks S6K phosphorylation. Inhibition of mTOR had been shown to suppress     substantially the liver tumor growth. Nevertheless, inhibition of mTOR was demonstrated to     have a clinical response in some cancer types. These reports imply that inhibition of mTOR     could be a promising therapeutic strategy in the treatment of HCC. Therefore, we hypothesize     that RAD001, a rapamycin analog, can inhibit the mTOR, and subsequently suppress the liver     tumor in the treatment of HCC patients.      This study is aimed to investigate the safety, efficacy, pharmacokinetics, pharmacogenetics     and feasibility of RAD001 in advanced HCC patients. This study will be a randomized phase I     study with dose escalation and subsequently a phase II study of intent to treat, as well as     pharmacokinetic, pharmacogenetic and surrogate marker study of RAD001.   "
194422|NCT00390208|"     The purpose of this study is to compare triple therapy using Photodynamic therapy,     intravitreal Dexamethasone and intravitreal Ranibizumab injections versus monotherapy with     intravitreal Ranibizumab alone for the treatment of Age-Related Macular Degeneration.   "
194423|NCT00390221|"     The primary objective of this study is to determine whether DAC HYP, when compared to     placebo, is effective in reducing the rate of relapses between baseline and Week 52. The     secondary objectives are to determine whether DAC HYP is effective in reducing the number of     new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2     hyperintense lesions, reducing the proportion of participants with relapses, and improving     quality of life.   "
194424|NCT00390234|"     This phase II trial is studying how well ziv-aflibercept works in treating patients with     locally advanced, unresectable or metastatic gynecologic soft tissue sarcoma. Ziv-aflibercept     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and     by blocking blood flow to the tumor.   "
194454|NCT00390624|"     The purpose of the study is to combine Urodilatin (ANP analogue), which will increase     glomerular filtration rate (GFR), and mannitol, which will increase the rate of urinary flow     and solute excretion. We intend to treat twenty consecutive allogeneic bone marrow transplant     patients in a phase II study comparing results with historical controls.      We hypothesize that the incidence of renal dysfunction, ARF and thus mortality in allogeneic     bone marrow transplantation can be significantly reduced by the use of protective agents     Urodilatin and mannitol. We feel that this combination is best administered prior to and     during the first two weeks of treatment when patients encounter immunosuppressive agents and     the onset of early transplantation complications.   "
194425|NCT00390247|"     Hypothesis In peritoneal dialysis (PD) patients, malnutrition, inflammation and     atherosclerotic cardiovascular disease commonly coexist. The triad has been coined the MIA     syndrome. Proinflammatory cytokines, such as tumor necrosis factor-alpha (TNF-alpha), plays     a central role in the pathogenesis of the MIA syndrome. Thalidomide selectively inhibits the     production of TNF-alpha and represents a valuable anti-cytokine therapy.      Specific Aim To study the effect of thalidomide in attenuating or reversing malnutrition and     systemic inflammation in PD patients.      Research Plan      Design: Double-blinded randomised prospective placebo control trial. Setting: Renal unit of a     university teaching hospital. Subjects: Sixty prevalent PD patients with evidence of     malnutrition. Interventions: Patients will be randomised to receive either oral thalidomide     100 mg nocte or placebo.      Main outcome measures: Patients will be followed for 1 year. Nutritional parameters including     serum albumin, subjective global assessment, malnutrition-inflammation score, normalised     protein nitrogen appearance, fat-free edema-free body mass and anthropometry measurements     will be monitored. Systemic inflammatory markers such as serum C-reactive protein and IL-6     will be assayed. Hospitalisation, cardiovascular events, and overall patient survival will     also be compared during study period.      Expected Outcome      Nutritional parameters and markers of systemic inflammation are expected to improve with     thalidomide therapy. The magnitude of improvement in nutrition, as well as patient morbidity,     will be compared with placebo.      In Hong Kong, 80% of end-stage renal failure patients are treated with PD. Malnutrition,     cardiovascular disease and systemic inflammatory response are all common in our clinical     practice. They are major causes of patient morbidity and mortality. As a readily available     anti-cytokine therapy, thalidomide may represent a valuable treatment of the MIA syndrome.     The proposed study will provide important insight on the clinical benefit of thalidomide     treatment in malnourished PD patients, which accounts for about one-third of our dialysis     population.   "
194427|NCT00390273|"     The main objective of this study is to evaluate the influence of metformin on lactate     metabolism.      The main outcome is the lactate production following an exogenous lactate overload in healthy     male subjects without metformin and one week later with metformin.   "
194428|NCT00390286|"     This is a 6 year, Phase I, Clinical Research Protocol to study the feasibility of using a     telemedicine system for performing research in a remote hospital system.   "
194429|NCT00390299|"     This phase I trial studies the side effects and best dose of carcinoembryonic     antigen-expressing measles virus (MV-CEA) in treating patients with glioblastoma multiforme     that has come back. A virus, called MV-CEA, which has been changed in a certain way, may be     able to kill tumor cells without damaging normal cells.   "
194430|NCT00390312|"     This study involves approximately 200 patients designed to evaluate the efficacy and safety     of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate     release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain     following third molar extraction.   "
194431|NCT00390325|"     This phase II trial studies how well sorafenib tosylate works in treating patients with     medullary thyroid cancer that has spread to other parts of the body (metastatic), spread to     the tissue surrounding the thyroid (locally advanced), or has returned after a period of     improvement (recurrent). Sorafenib tosylate may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
194432|NCT00390338|"     RATIONALE: Vaccines made from a person's dendritic cells mixed with tumor peptides and     proteins may help the body build an effective immune response to kill tumor cells. Infusing     the vaccine directly into the lymphatic system may cause a stronger immune response and kill     more tumor cells.      PURPOSE: This randomized phase I trial is studying the side effects and best dose of two     dendritic cell vaccines in treating patients with stage III or stage IV melanoma.   "
194433|NCT00390351|"     We will do systematic and functional assessment of non-melanoma skin cancer including     precancerous lesions by OCT imaging and other diagnostic methods. The systematic assessment     will be comparison of clinical diagnosis, histopathology, OCT images, spectrophotometry and     high frequency ultrasound of non-melanoma skin cancer Functional exploration of non-melanoma     skin cancer is done with Doppler-OCT and polarization-sensitive-OCT.   "
194434|NCT00390364|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with     advanced or metastatic colorectal cancer that did not respond to previous therapy.   "
194435|NCT00390377|"     This study aims to perform x-ray diffraction analysis of blinded hair samples from women with     a documented health status, to validate the previous findings of James et al who described     that x-ray diffraction patterns of human hair can distinguish samples from healthy subjects     from those of diseased subjects, specifically those suffering from breast cancer.      The primary hypothesis is that x-ray diffraction of hair can be used to distinguish hair from     patients with confirmed breast cancer from subjects without detectable breast cancer.   "
194436|NCT00390390|"     Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic     stomach contents move into the esophagus from the stomach. This study will investigate the     safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.   "
194437|NCT00390403|"     RATIONALE: Drugs used in chemotherapy, such as gossypol and temozolomide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Gossypol may help     temozolomide work better by making tumor cells more sensitive to the drug. Gossypol may also     make tumor cells more sensitive to radiation therapy. Giving gossypol and temozolomide     together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of gossypol when given     together with temozolomide with or without radiation therapy in treating patients with newly     diagnosed glioblastoma multiforme.   "
194455|NCT00390637|"     Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat     diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on     bodyweight in overweight and obese subjects after an initial weight loss.   "
194456|NCT00390650|"     The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to     placebo in patients with generalized anxiety disorder. The secondary objectives are to     evaluate the efficacy of saredutant on disability and quality of life in patients with     generalized anxiety disorder, and to evaluate blood levels of saredutant.   "
194457|NCT00390663|"     To determine whether the selective application of a combined treatment regimen of silver     nitrate cautery and 4 weeks of Naseptin cream is superior to naseptin treatment alone in the     management of recurrent paediatric epistaxis.   "
194438|NCT00390416|"     This study is being done to find out what effects a drug named/called bevacizumab has on     patients and patients' tumors when given together with standard chemotherapy drugs. Making     new blood vessels seems to be important for many tumors to grow. Bevacizumab is a new type of     treatment for cancer that blocks the growth of new tumor blood vessels. In this study, the     researchers will combine bevacizumab with chemotherapy drugs that are standard for the     patient's disease and include cisplatin, docetaxel, fluorouracil, and leucovorin. The way the     original combination of cisplatin, docetaxel, and fluorouracil was given caused many side     effects including gastrointestinal symptoms, weakness, and a drop in the blood count of     infection fighting cells. For this study, the researchers have modified this combination to     give lower doses of the medicines more often, to reduce side effects from the chemotherapy.     Patients will receive bevacizumab with this modified combination of docetaxel, cisplatin, and     fluorouracil. This study is called a phase II study. In this study, everyone will have     similar tumors and receive the same treatment.   "
194475|NCT00390897|"     To compare the complete cytogenetic response rate in patients with newly-diagnosed     chronic-phase chronic myeloid leukaemia treated with Glivec® alone or in combination with     interferon at low doses   "
194888|NCT00399035|"     The purpose of this study is to determine if Cediranib when added to chemotherapy is more     effective than chemotherapy alone in prolonging life expectancy and slowing disease     progression in patients with previously untreated metastatic colorectal cancer.   "
194439|NCT00390429|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving docetaxel together with erlotinib may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when     given together with docetaxel in treating patients with solid tumors and to see how well they     work in treating patients with advanced non-small cell lung cancer. (Phase I portion of the     study treating patients with any solid tumor was completed as of 12/01/2004)   "
194440|NCT00390442|"     In cardiogenic pulmonary edema, Continuous Positive Airway Pressure (CPAP) added to medical     treatment improves outcome. The present study was designed to assess the benefit of CPAP as a     first line treatment of cardiogenic pulmonary edema in the out-of-hospital environment.   "
194441|NCT00390455|"     This randomized phase III trial studies fulvestrant and lapatinib to see how well they work     compared to fulvestrant and a placebo in treating postmenopausal women with stage III or     stage IV breast cancer that is hormone receptor-positive. Estrogen can cause the growth of     breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering     the amount of estrogen the body makes. Lapatinib may stop the growth of breast cancer cells     by blocking some of the enzymes needed for cell growth. It is not yet known whether     fulvestrant is more effective with or without lapatinib in treating breast cancer.   "
194442|NCT00390468|"     RATIONALE: Tandutinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well tandutinib works in treating patients with     progressive prostate cancer and bone metastases.   "
194443|NCT00390481|"     To determine the relationship between cognitive functioning and blood flow in the brain among     patients randomized to either extracranial-intracranial (EC-IC) bypass or medical therapy     alone in the Carotid Occlusion Surgery Study (COSS).   "
194444|NCT00390494|"     The purpose of this study is to determine the change in symptoms and health-related quality     of life in patients undergoing treatment for fibroids. Results from the questionnaire will be     compared with results obtained from patients who do not have fibroids in order to determine a     score range that differentiates these two groups.   "
194445|NCT00390507|"     The purpose of this study is to examine the relationship between post-tetanic count (PTC) and     time to first response to Train of four (TOF) stimulation during deep neuromuscular blockade     induced by rocuronium.   "
194446|NCT00390520|"     This mechanistic study is designed to investigate the effect of vildagliptin on the     sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2     diabetes (T2DM).   "
194447|NCT00390533|"     The primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once     daily) of saredutant compared to placebo in patients with generalized anxiety disorder. The     secondary objectives are to evaluate the efficacy of saredutant on disability and quality of     life in patients with generalized anxiety disorder, and to evaluate blood levels of     saredutant.   "
194448|NCT00390546|"     This is a randomized, double-blind, multi-centered study to compare 6 months of medical     treatment with digoxin or propranolol in infants with SVT Background: SVT is the most common     sustained arrhythmia of infancy. Neither digoxin nor propranolol has been evaluated for     pediatric use in a controlled trial in the context of SVT, yet both medications are used     frequently.      Specific aims of the study:      To determine whether propranolol and digoxin differ in the:        1. Incidence of recurrent SVT in infants after 6 months of treatment with propranolol or          digoxin        2. Time to first recurrence of SVT in infants treated with propranolol or digoxin.        3. Incidence of adverse outcomes in infants treated with propranolol or digoxin.   "
194449|NCT00390559|"     Treatment studies have demonstrated that current smoking cessation techniques are less     effective for women. The purpose of this study is to determine the role that gender plays in     the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is     to determine whether men and women differ in their response to smoking-related stimuli (e.g.,     taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve     cessation interventions for all smokers, particularly women.   "
194450|NCT00390572|"     Sleep disorders are prevalent health problems that reduce quality of life, increase risks for     medical disease, and enhance healthcare costs/utilization. Only a small proportion of these     cases are diagnosed in primary care. Pilot data from this VA suggest that sleep disorders are     not adequately managed in a primary care setting: 33% of veterans with an insomnia complaint     had an undiagnosed primary sleep disorder (e.g., sleep apnea), and 50% of these patients were     prescribed pharmacologic treatment for insomnia by their primary care providers.   "
194451|NCT00390585|"     The purpose of this study is to demonstrate that Iodixanol 320 is associated with a lower     incidence of contrast-induced nephropathy (CIN) when compared with hyperosmolar contrast     medium Iomeprol 350 in patients with impaired renal function undergoing percutaneous coronary     interventions (PCI).   "
194452|NCT00390598|"     The trial compares Laxabon® 4L versus Pursennid® Ex-Lax 36mg and 2L Laxabon® for large bowel     cleansing prior to colonoscopy allocating patients planned for colonoscopy to one of the two     cleansing regimens.   "
194458|NCT00390676|"     N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer     progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study     will test the safety and effects of the combination ADH-1 and carboplatin or ADH-1 and     docetaxel or ADH-1 and capecitabine in subjects with specific incurable, solid tumors with a     protein biomarker called N-cadherin.   "
194459|NCT00390689|"     The objective of double blind phase in this trial is to compare the efficacy and safety at     the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label     phase in this trial is to investigate the long term safety and efficacy of pramipexole in     RLS.   "
194494|NCT00385164|"     Patients planned for radical radiation for NSCLC will undergo conventional CT stimulation and     also PET/CT scans for definition of radiation target volumes   "
195220|NCT00395213|"     This study will evaluate the risks and benefits of treatment with a selective serotonin     reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in children and adolescents     with a pre-specified anxiety disorder, depressive disorder, eating disorder, or     obsessive-compulsive disorder.   "
194460|NCT00390702|"     The Ventricular septal defect (VSD) is the most common of all congenital cardiac     malformations. By modifying the Nit-Occlud® PDA Device the Nit-Occlud® Lê VSD Spiral System     was designed. as a percutaneous, transcatheter device for occlusion of (peri)membranous and     muscular ventricular septum defects (VSD) with a spiral coil. In this clinical investigation     feasibility, safety and performance of the new cardiac occluder will be evaluated in     accordance with European and US regulations. The study data will be compared to performance     criteria for VSD, which are deduced analogue to the published specific Objective Performance     Criteria (OPCs) for PDAs. The first part of the study has been performed in three clinical     centres in Germany. For the second part in April 2009 four additional clinical centres in     Germany, Israel, Italy and Spain were included.   "
194461|NCT00390715|"     study of the value of the cytogenetics and the monitoring of the residual minimum disease in     the standard treatment of acute myeloblastic leukemia.   "
194462|NCT00390728|"     Primary objective:      AT.LANTUS main study*        -  To determine the optimal treatment algorithm for insulin glargine based on the incidence          of severe hypoglycaemia.(*Target Number of patients for the main study:2346)      HALT Sub-study**        -  To test the hypothesis that titration regimens involving insulin glargine are associated          with changes in the rate of symptomatic hypoglycaemic episodes together with changes in          Fear of Hypoglycaemia as measured by the HFS-98 Questionnaire in Type I          diabetes.(**Target Number of patients for the Sub-study: 250)      Secondary objectives:      AT.LANTUS main study      To determine:        -  the incidence of symptomatic, asymptomatic and nocturnal hypoglycaemia with each          treatment regimen        -  the difference in glycemic control as measured by HbA1c and fasting blood glucose with          each treatment regimen        -  the difference in glycemic control as measured by HbA1c and fasting blood glucose          between baseline and end of treatment        -  the safety on the use of insulin glargine in each treatment algorithm        -  the change in subject weight with each treatment regimen        -  the change in insulin doses with each treatment regimen        -  the change in Diabetes Treatment Satisfaction (Diabetes Treatment Satisfaction          Questionnaire, sub-study only) with each treatment regimen      HALT Sub-study (baseline to study end)        -  To estimate the relationship between change in HbA1c and incidence of hypoglycaemia        -  To examine the effect of insulin glargine on Quality of Life (EQ-5D) in relation to          incidence of hypoglycaemia        -  To examine the effect of insulin glargine on the Hospital Anxiety and Depression Scale          (HADS) in relation to the incidence of hypoglycaemia        -  To examine the use of the Prescription Plan versus standard management (no Prescription          Plan)   "
194463|NCT00390741|"     The major goals of this study are:        1. To conduct an intervention development study to evaluate the feasibility of implementing          an exercise intervention for reduction losses in bone mineral density, muscle mass, and          strength, and clinically relevant aspects of functioning following a hip fracture, and          to obtain preliminary tests of the effective ness of these interventions.        2. To evaluate the effect of home-based exercise intervention on bone metabolism.        3. To evaluate the effects of hip fracture on bone metabolism.        4. To evaluate the effects of exercise and hip fracture on hormonal regulators.        5. To evaluate the association between markers of bone metabolism hormone regulators, and          BMD.        6. To separate out the effects of hip fracture on bone turnover from those of aging in          persons with low bone mineral density.   "
194464|NCT00390754|"     The objective of this study is to determine whether women in a Medicaid population at risk     for unintended pregnancy will keep a home pregnancy test on hand and (if necessary) use it     appropriately.   "
194465|NCT00390767|"     The purpose of this study is to evaluate the safety and activity of increasing doses of     MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential     treatment for patients with peripheral arterial disease.   "
194466|NCT00390780|"     The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg     (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days     of treatment (at the test of cure visit, at Day 17-19).   "
194467|NCT00390793|"     The goal of this clinical research study is to find out if intensive chemotherapy combined     with dasatinib, followed by maintenance therapy, can help to control ALL with the Ph     chromosome and/or BCR-ABL. The safety of this treatment will also be studied.   "
194468|NCT00390806|"     The current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The     current standard treatment for this disease is radiation therapy to the brain. The goal of     the current study is to test whether the combination of orally administered HYCAMTIN capsules     and whole brain radiation therapy will prolong the survival time of patients with this     potentially serious condition.   "
194469|NCT00390819|"     Pneumonia in general and CAP in particular is considered as one of the most common bacterial     infections, associated with high rates of morbidity and mortality and is highly significant     economically since all respiratory infections, and pneumonia especially, cause about 80% of     antimicrobials use in the community. The high frequency of respiratory infections and the     excessive use of antimicrobials are major contributors to the development of pathogens     resistant to antimicrobials. In addition, in CAP almost all patients are treated empirically,     without identification of causing pathogen.      Aim of study: To identify common pathogens causing CAP in hospitalized patients in north     Israel.   "
194470|NCT00390832|"     The purpose of this study is to determine whether erythropoietin is superior to placebo with     respect to left ventricular ejection fraction in patients with ST-elevation myocardial     infarction undergoing percutaneous coronary intervention.   "
194471|NCT00390845|"     This will be a double-blind, placebo controlled cross-over study. After enrolment and initial     assessments, subjects will receive oral SB681323 or matching placebo for 14 days. SB681323     will be administered twice daily at a total daily dose of 7.5mg. Sufficient numbers of     patients will be recruited to obtain 40 evaluable patients   "
194472|NCT00390858|"     In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox     in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients     who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in     this extension trial and receive chelation therapy with deferasirox for up to 4 years.   "
194490|NCT00385112|"     The purpose of this study is to determine if the Medtronic Freestyle porcine valve is     effective over a long period of time when it is used to replace the valve that normally     allows blood to flow from the right lower pumping chamber of the heart to the lungs.   "
194473|NCT00390871|"     Dexmedetomidine (Precedex, Hospira) is a super selective alpha2-agonist - 8-10x more avid     binding to alpha2 receptors than clonidine - and may have particularly favorable     characteristics as a continuous i.v. infusion sedative for critically ill neuroscience     patients. Its combination of anxiolysis, analgesia, without undue lethargy may make it an     ideal agent where frequent neurological examinations are important (12). Unclear, however, is     whether Precedex is superior to current common i.v. sedation protocols, and if there are any     undue concerns of this agent on cerebral physiology and cortical stimulation.   "
194474|NCT00390884|"     To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone     vaccine (2006-2007 formulation).   "
194476|NCT00390910|"     This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline     (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with     diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio     virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose     primary immunization course during the first 6 months of life.      This protocol posting deals with objectives & outcome measures of the primary study. The     objectives & outcome measures of the Booster study are presented in a separate protocol     posting (NCT number = 00609492)   "
194477|NCT00390923|"     This study will test a new medication strategy designed to help smokers quit. It will combine     selegiline, a drug currently approved and available for the treatment of Parkinson's disease,     with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study.     Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive     selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine     Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief     health check, collection of breath and urine samples (necessary to drug levels and nicotine     levels), and receive brief individual counseling designed to help them stop smoking. The     medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months     after trial completion. At that point, health and behavioral measures will be re-assessed.   "
194478|NCT00390936|"     The purpose of this study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the     maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors.   "
194479|NCT00390949|"     The purpose of this study is to determine whether community-based peer education and condom     distribution combined with improved treatment of sexually transmitted infections are     effective in reducing the spread of HIV infection in a sub-Saharan African population   "
194480|NCT00390962|"     Sodium imbalance is common and an adverse prognostic factor in hospitalized patients.     However, identifying the causes of sodium imbalance is challenging in clinical practice.     Levels of antidiuretic hormone (ADH) are elevated in patients with stroke correlating with     disease severity and stress level; however, its measurement is cumbersome. ADH is derived     from a larger precursor peptide along with Copeptin, which is a more stable peptide directly     mirroring the production of ADH. Copeptin can be assayed readily in plasma. Early prognostic     factors to predict in-hospital mortality and medium/long-term outcome in critically ill     neurological patients, are helpful to guide and tailor early decisions on treatment,     discharge from the intensive care unit and application of interventions to prevent     deterioration of neurological functions.      We hypothesize that copeptin will improve the diagnostic accuracy to diagnose sodium     imbalances as compared to routinely used markers Furthermore, we hypothesize that Copeptin     will be a reliable prognostic tool, dependent or independent of sodium imbalance, to predict     short-term (i.e. in-hospital) and medium-term (i.e. 3 months) clinical outcome in stroke     patients.   "
194481|NCT00390975|"     This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis     treated with tegaserod over 2 weeks.   "
194482|NCT00390988|"     The purpose of this study is to compare capillary blood count parameters with the     corresponding venous samples to verify the hypothesis that capillary and venous blood count     parameters are equivalent.   "
194483|NCT00391001|"     Recently, McLean hospital conducted a 4 month taurine study which showed a reduction in mania     ratings. As a follow-up to the preliminary taurine study, and complementary to the currently     ongoing double-blind, placebo-controlled trial for taurine in adults with bipolar disorder,     this study will target adolescent bipolar subjects (type I) with symptoms of mania or mixed     mania. To our knowledge, this would be the first study to evaluate the effects of the novel     compound taurine in adolescent subjects with bipolar disorder.      We hypothesize there will be a positive response in some adolescents from taurine treatment,     and this positive response will be greater than that expected by chance. This study may     demonstrate that taurine is a well-tolerated and effective adjunct treatment for mania in     bipolar disorder.   "
194484|NCT00385021|"     To determine efficacy in the delivery of chronomodulated chemotherapy.   "
194485|NCT00385034|"     This study tested the effectiveness of computer-assisted screening for identifying patients     at risk of intimate partner violence (IPV) in a Canadian family practice. It was hypothesized     that the use of computer-assisted screening among female patients would lead to higher rates     of IPV discussion-opportunity and IPV detection during medical consultations, compared to     patients receiving standard medical care.   "
194486|NCT00385047|"     The purpose of this study is to determine whether 2 investigational malaria vaccines are safe     as well as protective against malaria in adults living in the United States   "
194487|NCT00385073|"     Participants will complete a self-selected intensity of exercising over a 6 month period,     with detailed clinical assessments at commencement and completion to determine the rate of     progression of parkinsonism and gait abnormalities   "
194488|NCT00385086|"     TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis.     Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.   "
194489|NCT00385099|"     The purpose of this study is to see if GW876008 in Irritable Bowel Syndrome patients will     reverse stress-induced hypersensitivity, by looking at thresholds for perception and pain.   "
194492|NCT00385138|"     The primary objective of this study is to demonstrate that the efficacy of cangrelor     (combined with usual care) is superior to that of usual care, in subjects requiring     percutaneous coronary intervention (PCI) as measured by a composite of all-cause mortality,     myocardial infarction (MI), and ischemia-driven revascularization (IDR).   "
194493|NCT00385151|"     Reperfusion Injury occurs by the sudden blood flow to the injured and ischemic myocardium     during restoration of blood flow either by Mechanical revascularization or thrombolysis. A     phenomenon known as Pre-conditioning has been identified to limit the the extent and severity     of reperfusion injury but it is very difficult to apply it in patient care setting as timing     of acute cardiac or neurologic ischemic event is difficult to reliably predict.      Postconditioning or ischemic postconditioning is well known to attenuate the reperfusion     injury. There is enough data that shows the benefit of post conditioning in reducing the     reperfusion injury in animals. However postconditioning in humans has not been investigated.      We hypothesize that Post conditioning will attenuate the reperfusion injury and will be     comparable to the effect of preconditioning in humans.   "
194495|NCT00385177|"     This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced     solid malignancies. The study is designed to determine the maximum tolerated dose and     dose-limiting toxicity of SN2310 Injectable Emulsion, and to characterize the     pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310     Injectable Emulsion. Additionally, evaluation of side effects as a function of dose, and     observation of any anti-tumor effects of SN2310 Injectable Emulsion will be made.   "
194496|NCT00385190|"     The purpose of the study is to assess the safety and tolerability of ascending multiple oral     doses of HCV-796 in healthy Japanese male subjects.   "
194497|NCT00385203|"     To determine the anti-tumour activity and biological effects of cediranib (AZD2171) at a dose     of 45mg, primarily in Gastrointestinal Stromal Tumour (GIST) patients who are resistant to     imatinib mesylate (current standard therapy) and also in patients with metastatic Soft Tissue     Sarcoma (STS) resistant to standard therapy.   "
194498|NCT00385216|"     Third molar surgery is complicated by pain and swelling for several days after surgery.     Non-steroidal antiinflammatory drugs have been useful in combination with opioids for     treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine     or placebo as a nasal spray before surgery to determine whether nicotine affects pain or     inflammation.   "
194499|NCT00385229|"     Post term pregnancy is a risk pregnancy. Aim of the study was to investigate whether     induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity     compared to expectant management. Secondary aims was to assess the effect on mode of delivery     and maternal complications, as well as assess women's views and experiences.      Our 0-hypothesis was that induction of labor at gestational age 41+2 did not result in better     outcome of pregnancy, measured as perinatal morbidity.      Following inclusion, women were randomly allocated to induction of labor or to monitoring of     pregnancy every third day until delivery   "
194500|NCT00385242|"     Rationale: Patients with severe ventricular dysfunction and coronary disease have high     morbidity and mortality. They may benefit from revascularization, but have significant     peri-operative morbidity and mortality. Positron emission tomography (PET) imaging with     F-18-fluorodeoxyglucose (FDG) can detect viable myocardium that may recover from     revascularization in such patients. It is unclear whether use of FDG PET in this population     is improves outcome or is cost-effective.      Objectives: The principal aim is to determine whether FDG PET-guided therapy is effective     versus standard care. Secondary objectives are to determine whether FDG PET-guided therapy     improves LV function, quality of life and is good value for money versus standard care.   "
194501|NCT00385255|"     The current study will provide information for the use of Boostrix concomitantly with     influenza vaccine in adults aged 19-64 years. This study will also provide safety and     immunogenicity data in a cohort of adults aged greater than or equal to 65 years.   "
194502|NCT00385268|"     Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of     cocaine dependence.   "
194503|NCT00385281|"     The purpose of this study is to look at changes that occur in blood and nasal swab samples     after a person's immune system responds to receiving a flu vaccine. The investigators will     look at the immune response in 50 healthy volunteers, between 21 and 49 years of age, after     they have been vaccinated with 1 dose of a flu vaccine sprayed into the nose. A blood sample     and nasal swab of each nostril will be collected from volunteers before they receive the flu     vaccination. After receiving the flu vaccine, volunteers will record health changes and daily     temperatures on diary cards at home for 21 days. Blood will be drawn and nasal swabs will be     collected from each volunteer at each of the 6 study visits. Volunteers will participate in     the study for approximately 1 month. This study is being conducted at the Glennan Center for     Geriatrics and Gerontology at Eastern Virginia Medical School.   "
194504|NCT00385294|"     We wish to understand why labor is more painful for some women compared to others.We will     study whether a woman's baseline pain sensitivity, beta2 adrenergic receptor genotype is     related to her pain in labor for the birth of a first child.   "
194505|NCT00385307|"     To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared     to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as     positive control. In addition, the tolerability and safety of SR58611A in patients with MDD     will be evaluated.   "
194506|NCT00385320|"     The purpose of this study is to test how infants respond to different strengths of the human     rotavirus vaccine.   "
194547|NCT00391638|"     HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a     non progressive liver infection and a better clinical outcome. However, the rate of HBe     seroconversion is low in HIV-HBV co-infected patients, mostly treated by tenofovir and     emtricitabine. This study will evaluate the efficacy and the safety of a one-year     Peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and     emtricitabine without reaching HBe seroconversion.   "
194771|NCT00397462|"     This project will test the efficacy of using a non-invasive neuromuscular stimulation on the     plantar surface of the feet to prevent and/ or reverse bone loss in a sample of healthy adult     women.   "
194507|NCT00385333|"     This study will test whether a new non-invasive technique can quickly and precisely measure     retinal metabolism (the amount of energy retinal cells use). The retina is the part of the     eye that sends information to the brain.      Participants in current NEI studies who have age-related macular degeneration (AMD), diabetic     retinopathy, or von Hippel-Landau disease may be eligible for this study. Healthy volunteers     will participate as controls. Patients with AMD must be 60 years of age or older; those with     VHL disease or diabetic retinopathy must be 18 or older.      Participants undergo the tests and procedures required in the NEI study in which they     previously enrolled. In addition, for the current study, they undergo metabolic mapping. For     this procedure, the subject's eyes are dilated, and different amounts of low-level light are     shone into the eye to see how different cells respond with changes in metabolism.     Measurements are taken while the subject breathes room air and while he or she breathes     medical grade oxygen for about 1 minute. The entire procedure takes about 15 minutes.   "
194508|NCT00385346|"     The purpose of this study is to determine whether expressive writing can be effective in     improving the well-being and sperm quality in patients with male infertility.   "
194509|NCT00385359|"     Albuterol (salbutamol) is a widely used asthma medication but is associated with undesirable     side effects such as shakiness and increased heart rate. Targeted delivery of albuterol to     area of lungs where it has most effect would require a lower total dose to produce the same     beneficial effects while reducing the side effects.      It is anticipated that only 1/13th to 1/25th of the standard nebulized dose of albuterol will     be required to attain same bronchodilator response as a standard nebulizer treatment as     determined by lung function measurement and that the reduced dose will significantly reduce     side effects as determined by hand tremor and heart rate.   "
194510|NCT00385372|"     Patients with chronic urticaria undertake a five week elimination diet (pseudoallergen free     diet). The efficacy of the diet will be determined by symptom score, by the use of rescue     medication (oral antihistamines and glucocorticosteroids) and by a Quality of Life     Questionnaire on week 0 and week 5. All patients with sufficient response (regarding the     urticaria score) enter a second dietary part over six weeks, whereas a provocation diet is     carried out. Each diet week a choice of pseudoallergen rich food is added, sorted by the type     of pseudoallergens (e.g. biogenic amines, organic acids, flavours, additives). This study is     conducted to investigate if the provocation diet could be a new diagnostic intervention to     elucidate clinical relevant pseudoallergens.   "
194511|NCT00385385|"     The objective of this study is to evaluate an antibiotic therapy called Rifalazil to     determine its effect on hardening of the carotid arteries.   "
194512|NCT00385398|"     RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function     (the ability to think, learn, remember, and judge) in patients with non-small cell lung     cancer and brain metastases. A study that evaluates brain function may help doctors plan the     best treatment.      PURPOSE: This phase II trial is studying the effect of radiosurgery, temozolomide, and     erlotinib on brain function in patients with non-small cell lung cancer and brain metastases.   "
194513|NCT00385411|"     Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of     valproate administered as microgranules, under standard prescription conditions, with     therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations     and antiepileptic comedication as well as biological assays.      Secondary objectives: Ancillary population kinetics study        -  Estimate the pharmacokinetic parameters of valproate administered as microgranules under          standard therapeutic conditions within the population studied, from the therapeutic          follow-up data.        -  Evaluate the influence of individual characteristics on the pharmacokinetic parameters.        -  Describe the relationship between plasma concentrations and adverse events for valproate          and the main anti-epileptic comedications.   "
194514|NCT00385437|"     This concurrent, two-part study will:      I) Using overnight sleep recordings, evaluate the short- and long-term sleep-promoting     effects of the antidepressant mirtazapine (Remeron) in patients who have been prescribed this     medication for major depressive disorder and sleep disruption.      II) Investigate the psychomotor performance of depressed patients using driving simulation     testing before and during treatment with mitrazapine.   "
194515|NCT00385450|"     In previous studies, 90% of patients who underwent elective cardiopulmonary bypass procedure     manifested CD4 counts of less than 500 cells/microliter in the immediate (day 1)     post-operative period. This study will investigate whether or not Nelfinavir increases those     CD4 counts in the post-operative period.   "
194516|NCT00385463|"     The four respiratory drugs being researched in this study have been approved by the US Food     and Drug Administration (FDA) and are currently available by prescription at your drug store.     One of the drugs is for the treatment of asthma alone, one is for treatment of SAR alone, and     one is for treatment of both SAR and asthma. In addition, you will also receive one asthma     rescue drug (albuterol) that is to be used for any breakthrough asthma symptoms that you may     experience throughout the study.      The purpose of this study is to see how well your asthma and SAR are controlled when taking     one of the medicine combinations   "
194517|NCT00385476|"     The goal of the study is to learn about patients' knowledge of their medications in an     outpatient acute care setting (such as the M. D. Anderson Emergency Center) and to learn     about any clinical factors that affect patients' knowledge of their medications.   "
194518|NCT00385489|"     The purpose of this study is to evaluate the safety of LXR-623 in healthy Japanese subjects.   "
194519|NCT00385502|"     Approximately 40 qualified subjects with mild-to-moderate great toenail fungus infection will     be treated for 48 weeks with lacquer application to at least one affected great toenail. All     subjects will receive treatment with EcoNail™ lacquer.   "
194520|NCT00391014|"     The trial is planned as a multicentric, national, phase II, open-label trial to evaluate     safety and tolerance of nebulized Liposomal Amphotericin B (Ambisome) for LMA patients during     the induction therapy ,intensification, plus Allogeneic Haematopoietic Progenitor Cell     transplant in due course, as well for patients diagnosed of several malignant haematologic     diseases and treated with Allogeneic Haematopoietic Progenitor Cell Transplant   "
194521|NCT00391027|"     To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes     mellitus.   "
194523|NCT00391053|"     Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus,     improvement of the immune response to influenza vaccination in this age group, which is at     higher risk for influenza-related morbidity and mortality, represents an important unmet     need.      Primary Objectives:      Immunogenicity:        -  To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing          process through evaluation of the immune responses elicited by three different lots.        -  To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone®          vaccine.      Secondary Objectives:      Immunogenicity:        -  To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone®          vaccine.      Safety:        -  To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited          adverse and serious adverse events post-vaccination.        -  To describe clinical information on some additional defined criteria during the six          months following vaccination.   "
194524|NCT00391066|"     This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with     previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either     lumiliximab in combination with FCR or FCR alone.   "
194525|NCT00391079|"     The purpose of this study is to find out if cannabis-based medicine compared to a dummy     medicine (placebo that contains no active ingredient) can help the central neuropathic pain     patients experience as a result of multiple sclerosis. This type of pain central neuropathic     pain is described as shooting, stabbing, burning or searing like sensation, which is often     worse at night.   "
194526|NCT00391092|"     This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel,     versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or     metastatic breast cancer who have not received prior chemotherapy for their metastatic     disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) +     Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv     q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until     disease progression, and the target sample size is 100-500 individuals.   "
194527|NCT00391105|"     In this randomised controlled study we intended to compared intubation conditions and the     continuous infusion of remifentanil (n=10) and morphine (n=10) in mechanically ventilated     premature neonates (28-34wk) regarding the time to be awake and, the time until extubation     after interruption of the opioid administration.   "
194528|NCT00391118|"     Patients with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial     treatment. In many patients the tumor will shrink, or even disappear, after treatment with     these drugs. But, unfortunately, the tumor will grow again in many patients. This trial will     try to address the question: Can we delay the time, till the tumor grows again, by adding a     3rd drug to the standard therapy? To answer this question, patients will, by chance, either     get the experimental drug enzastaurin or a dummy pill (placebo) during the chemotherapy and     for up to 3 years after chemotherapy. Patients and physicians will not know, if a patient     gets enzastaurin or placebo (double-blinded trial). After a predefined time, the treatment     will be uncovered, and the number of patients with tumor growth at a specific time point will     be compared between the two treatments.   "
194529|NCT00391131|"     This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig     NextGen 16% in people with antibody deficiency currently being treated with IntragamP. Ig     NextGen 16% is a liquid immunoglobulin (antibody) preparation manufactured using     predominately chromatographic techniques. Eligible patients will switch from monthly     intravenous IntragamP therapy to weekly subcutaneous Ig NextGen 16% treatment. Initial     hospital training will be required for subcutaneous administration and then the patient will     perform the infusion in their own home, returning once a month for a supervised infusion.     Patients will be monitored on the study for up to 10 months to assess blood IgG levels and     rate of serious bacterial infections.   "
194530|NCT00391144|"     The natural history of subfoveal CNV secondary to Pattern Dystrophy is little understood, but     it seems that visual function may be preserved only in the short-term follow-up, with     progressive deterioration thereafter.      Photodynamic therapy with verteporfin is the most studied therapeuthic option for this kindf     of lesion, but unfortunately, this approach does not appear to guarantee long-term vision     stabilization, and alternative therapies should be investigated.   "
194531|NCT00391157|"     The primary efficacy objective of this study is to study the efficacy in terms of response     rate to alternating bortezomib/dexamethasone regimen   "
194532|NCT00391170|"     This study will determine if a dexamethasone mouth rinse can reduce the risk of developing     oral chronic graft-versus-host disease (cGVHD) in patients who have undergone a bone marrow     (stem cell) transplant procedure. cGVHD is a common complication of stem cell     transplantation, resulting from the donor cells attacking the transplant recipient's tissues.     In oral cGVHD, the tissues in the mouth are damaged, causing painful mouth sores.     Dexamethasone is a corticosteroid that is commonly used to treat inflammation. It is the only     corticosteroid available that can be used as a mouth rinse.      Patients 12 years of age or older who have received a stem cell transplant may be eligible to     participate if they are enrolled within 70 to 90 days of their transplant. Candidates are     screened with a medical history and oral exam.      Participants are randomly assigned to receive either the dexamethasone rinse or a placebo (a     solution that looks and tastes like the dexamethasone rinse but has no active medication).     They undergo the following procedures:      Treatment with the study solution. Patients rinse their mouth with the dexamethasone solution     or placebo three times a day for 3 months.      Clinic visits before starting treatment and at 1, 2 and 3 months after starting the study     drug for the following procedures:        -  Oral exam (before starting treatment and at each visit).        -  Photographs of the mouth (before starting treatment and at 3 months).        -  Biopsy from inside the cheek (before starting treatment). The inside of the cheek is          numbed and a small piece of tissue is removed for examination by a pathologist.        -  Saliva sample collection (before starting treatment).        -  Blood draw (before starting treatment and at each visit).        -  Quality-of-life questionnaires (before starting treatment and at 3 months).        -  Questionnaire to assess level of dry mouth and mouth pain (before starting treatment and          at each visit).        -  Review of medications (at each visit).        -  ACTH stimulation test to evaluate adrenal gland function (at 3 months). Patients are          given an injection of a drug called ACTH or cosynthropin, which is a version of a          hormone normally produced by the pituitary gland. Blood samples are drawn before the          injection and at 30 and 60 minutes after the injection to measure levels of the hormone          cortisol.      After treatment ends, participants are contacted by telephone every month for 6 months to     report any symptoms of cGVHD, and they return to the clinic at 6 months for a final     evaluation.   "
194533|NCT00391183|"     The purpose of the study is to determine whether palliative biliary stenting improves the     quality of life, of gallblader cancer patients, who present with hilar block and obstructive     jaundice.   "
194534|NCT00391196|"     The purpose of this study is to determine if CP-945,598 is effective in the treatment of     obesity in type 2 diabetic patients.   "
194654|NCT00393068|"     The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib)     further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation     therapy in patients with operable esophageal cancer.      Side effects (toxicity) information will also be collected.   "
194535|NCT00391209|"     This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month     study with approximately 360 patients will compare the efficacy of two treatment regimens     (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally     controlled by one or more oral antihyperglycemic medications. Patients will be assigned     randomly to receive one of the following treatment groups:      Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose     of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of     Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose     values for the first month and titrating 1 time per week based on once weekly 4-point blood     glucose values for the remainder of the study, increasing total daily dose by a maximum of 6     U per day.      Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted     dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose     values, with sustained monitoring of dose and blood glucose throughout the study, increasing     total daily dose by a maximum of 8 U per day.   "
194536|NCT00391222|"     The purpose of this randomized, double blind, double dummy, multicenter study was to evaluate     the efficacy of risperidone long-acting injectable (LAI) monotherapy in comparison with     placebo in the prevention of a mood episode in treatment of patients with bipolar I disorder.     Oral olanzapine was used to assess the validity of the study design. The primary objective of     this study is to evaluate the efficacy of risperidone LAI versus placebo in the prevention of     a mood episode (recurrence event) in patients with bipolar I disorder after a 12-week (3     month) stabilization period on risperidone LAI, as measured by the time to recurrence of any     mood episode. Risperidone LAI has been approved by the FDA in the USA for the treatment of     patients with schizophrenia and for the prevention of mood recurrences in bipolar I disorder,     as monotherapy or add-on treatment. It is approved at EMEA and other European and     non-European health authorities for the treatment of patients with schizophrenia, too.   "
194537|NCT00391235|"     Fourteen subjects with bipolar disorder and 14 matching healthy controls, aged 6-13, will     receive a magnetic resonance imaging (MRI) scan on a 3 Tesla scanner. They will also have a     clinical interview, including the KSADS-PL. All subjects must be right-handed.   "
194538|NCT00391248|"     To improve the clinical outcomes of patients with non-small cell lung cancer treated with     radiation therapy.   "
194539|NCT00391261|"     The aim of this study is to evaluate the effectiveness, safety, and tolerability of metformin     treatment in children and adolescents suffering from weight gain secondary to use of atypical     antipsychotic medications. In this 12 week, open-label study we will investigate metformin's     effects on weight control and/or weight loss. We hypothesize that metformin would prevent     further weight gain or lead to weight loss, resulting in amelioration of one of the most     significant side effects of atypical antipsychotic use.   "
194540|NCT00391274|"     The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel     administered on a 3-weekly schedule in the treatment of patients with locally advanced or     metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.   "
194541|NCT00391287|"     The purpose of this study is to estimate the incidence rate of pure red cell aplasia (PRCA;     aplastic anemia) mediated by erythropoietin (EPO) antibodies in patients who are receiving     subcutaneous (s.c.) epoetin alfa (polysorbate 80 formulation) for the treatment of anemia     associated with chronic renal failure (CRF), and to compare this incidence rate to the     incidence rate with s.c. exposure to other currently marketed recombinant erythropoietin     products (epoetin alfa, epoetin beta, darbepoetin alfa), with adjustment of duration for     which the drug is given to the patient. The study will also examine the impact of the pattern     of using mixed s.c. exposure to multiple erythropoietin products occurring in this patients,     and the impact of the time from which the treatment is started to the onset of PRCA.   "
194542|NCT00391300|"     RATIONALE: New diagnostic procedures, such as bioelectric field imaging, may help find and     diagnose melanoma and other skin cancers. It may also be a less invasive way to check for     skin cancer.      PURPOSE: This phase I trial is studying bioelectric field imaging in diagnosing melanoma and     other skin cancers in patients with skin lesions.   "
194543|NCT00391313|"     A severe outbreak of Chikungunya fever has been reported at La Réunion Island (France) in     2005-2006. Chikungunya is a viral disease. Chikungunya virus is an alphavirus transmitted to     humans by the bite of infected mosquitoes, usually of the genus Aedes (Aedes albopictus in La     Réunion).      To date, more than 266,000 cases were estimated to have occurred in the island (760,000     inhabitants). Most of cases are expressed as a mild disease, with intense fever and     arthralgias, with rare but serious complications (encephalitis, liver, cardiac or renal     failures.) having required a hospitalization in an intensive care unit. 273 of such serious     cases (immediately life threatening condition) have been reported among the cases, in     patients aged over 10 days (59% were 65+ age old). Chikungunya was proven in 246 serious     cases; 101 patients had comorbidities, and 27% of confirmed cases eventually died. In     addition 44 cases of mother-to-child infections were reported and 40 were confirmed (one     died).      To date, in 248 death certificates, chikungunya was reported as the direct or indirect cause     of death, with a median age of 79, range 0-102, and a sex-ratio (M/F) of 0.95. InVS, in     collaboration with Inserm (French NIH) also reported (by June 6, 2006) a significant excess     of mortality (from all causes) during the major outbreak which occurred from December, 2005     (+10%) to April, 2006 (10.1%), with a peak of excess mortality reached in February (+34.4%),     concommitant to the peak of incidence.      Today, there is no antiviral treatment against Chikungunya. We showed from ex-vivo studies     (in a sensitive model of cells culture to the viral infection) that chloroquine provides a     significant inhibition on the replication of the Chikungunya virus. This efficacy seemed also     to be reached at a plasmatic concentration of similar order of magnitude as recommended for     treating malaria with this drug.      This trial aims to assess efficacy and safety of chloroquine as as therapeutic treatment of     chikungunya disease.   "
194544|NCT00391326|"     The purpose of this study is to describe the efficacy and safety of prehospital     administration of bivalirudin, as a substitute for heparin, in patients with acute myocardial     infarction redirected for primary angioplasty bypassing local hospitals, immediately after     the diagnosis is confirmed via tele-transmission of a 12-lead electrocardiogram.   "
194545|NCT00391339|"     In a prospective, randomised study the efficacy and tolerability of bryophyllum p. (p.o) vs.     nifedipine (p.o) will be proofed in a defined group of pregnant women with threatened preterm     labour.   "
194546|NCT00391625|"     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme     glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside     accumulates within macrophages leading to cellular engorgement, organomegaly, and organ     system dysfunction. The purpose of this study is to evaluate the long term safety of enzyme     replacement therapy with DRX008A (VPRIV®, GA-GCB; velaglucerase alfa) in patients with type 1     Gaucher disease.   "
194581|NCT00392080|"     CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the     treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to     evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer     gastrointestinal ulcers compared to patients treated with naproxen and placebo.   "
194582|NCT00392093|"     Hypothesis, HRT does not increase the risk of lupus activity exacerbation, it is effective     for the relief of menopausal symptoms and improves bone mineral density.      Double-blind, randomized, placebo controlled clinical trial.      Objectives        1. Determine the effect of HRT on disease activity, menopausal symptoms, bone mineral          density, lipid profile, and mammographic parenchymal density in menopausal women with          SLE.        2. Determine the incidence rate of major side effects of HRT in menopausal women with SLE.      Outcome Measures        1. Primary outcome will be global disease activity throughout the follow-up period.        2. Incidence of lupus flares, time to the first flare, changes in SLEDAI values from          baseline at each follow-up visit, maximum disease activity, lupus treatment,          hospitalizations, thromboses, and deaths.      Menopausal symptoms and depression will be assessed utilizing the Greene Climacteric Scale     questionnaire and the Beck Depression Inventory.      Bone mineral density of lumbar spine and hip will be performed with dual energy x-ray     absorptiometry. In addition, blood and urine samples to measure biochemical markers of bone     turnover.      Estradiol levels, lipid profile,coagulation tests, cervical cytology examinations,     mammography.      Inclusion Criteria: (Any two of the following criteria)        1. Amenorrhea of 6 months or more        2. Serum FSH level of 30 IU/L or more        3. Menopausal symptoms        4. Age 48 years or older.      Exclusion Criteria:        1. Women older than 65 years        2. Severe lupus activity at baseline        3. Use of estrogens within 3 months of the screening visit        4. Serum creatinine of 2.0 mg/dL or more        5. Hypertriglyceridemia 500 mg/dL or more        6. Metabolic bone diseases        7. Liver disease        8. Untreated hyperthyroidism        9. Recent thrombosis       10. Malignancy       11. Endometrial hyperplasia       12. Undiagnosed uterine bleeding       13. Cervical dysplasia.      Subject allocation Random assign, using a computer-generated randomization list to:     Conjugated equine estrogens 0.625 mg/day plus 5 mg/day of medroxyprogesterone acetate p.o.     for the first 10 days per-month, or biologically inert placebo.All women will receive 1200 mg     of calcium carbonate and 800 IU of vitamin D, daily.      Follow-up procedure All patients will be evaluated by a rheumatologist and a reproductive     health specialist at baseline,1,2,3,6,9,12,15,18,21, and 24 months.      Rheumatic evaluation:        1. General information (baseline).        2. Lupus activity (every visit).        3. Medications: (every visit)      Gynecological evaluation:      Onset of symptoms since the previous visit using a standardized questionnaire. In addition, a     gynecological examination will be performed.      Criteria for early termination of the study:      A patient will be discontinued from the study whenever any of the following criteria would be     present:        1. Development of severe lupus activity (SLEDAI > 30).        2. Development of any putative complication to hormone therapy.        3. Development of any other severe complications due neither to SLE nor hormone therapy.        4. Need prolonged immobilization.      Statistical analysis:      Between-group comparisons of lupus activity, maximum SLEDAI, and change in SLEDAI score from     baseline at each follow-up visit. Incidence-density rates of flares with relative risk and 95     percent confidence intervals.Probability of flares throughout the study using life-table     analyses and log-rank test.      Climacteric symptoms as the mean value of the Green’s scale score at baseline and at each     follow-up visit, between-group and intra-group. Bone mineral density as the mean value at     baseline, 12 and 24 months, between and intra-group.      The proportion of patients in each group who develop secondary effects, as well as the number     who quit the study during the follow-up period.      Continuous variables will be compared using Student's t-test, and categorical variables using     chi-square or Fisher’s exact test. Within-group comparisons will be done using the Wilcoxon     signed-rank test. P values will be two-sided. Analyses will be conducted by the     intention-to-treat method.   "
194583|NCT00392106|"     The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is     effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best     medical therapy with FDA approved antiarrhythmic drugs.   "
194584|NCT00392119|"     The purpose of this study is to determine if the stereotactic, MR guided, laser interstitial     thermal therapy treatment technique can be safety and efficiently used for human brain     metastasis and primary brain tumors.   "
195676|NCT00400933|"     The aim of this project is to analyze the impact of a psycho-educational group program on the     family members and close friends of persons with eating disorders and co-morbid personality     disorders.   "
194548|NCT00391651|"     The purpose of this research study is to determine what the cure rates are with a 5 day     course of nitrofurantoin versus the more standard 3 day course of     trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and     what length of therapy is best for treatment of UTI, taking into account the problem of     antibiotic resistance.      Procedures subjects will undergo once they have read and signed the consent are:      Questions about their medical and sexual history and current symptoms of UTI. They will be     asked to provide a urine sample and then randomly assigned to one of the two treatment     groups.      will be obtained at each visit. If they were assigned to the nitrofurantoin treatment     regimen, they will also be asked to collect a urine sample at home on the third day. If the     subject develops recurrent urinary symptoms or does not have resolution of symptoms after     completing the initial treatment course, they will be asked to return to the clinic and     provide another urine sample for analysis. They will then be treated with another standard     antibiotic at no cost to them and will be withdrawn from the study at that time.      The study population is women ages 18-45 with acute symptoms of a UTI without a history of     UTI in the past 6 weeks.   "
194549|NCT00391664|"     The purpose of this study is to evaluate the quality of life of long-term gynecologic cancer     survivors.   "
194550|NCT00391677|"     This study will evaluate the effectiveness of attention shaping procedures in improving     attentiveness and learning abilities in people undergoing psychosocial skills training     treatment for schizophrenia.   "
194551|NCT00391690|"     It is the aim of this prospective, single-group, clinical study to assess whether bone     parameters can be used as diagnostic tools for early detection of bone metastases in patients     with high risk prostate cancer. The usefulness in monitoring zoledronic acid therapy in     patients who have developed bone metastases will also be assessed.   "
194552|NCT00391703|"     This is an add-on, randomized, open label, clinical trial that evaluates the use of     quadriceps electrostimulation as an additional retraining procedure in patients suffering     from cystic fibrosis.   "
194553|NCT00391716|"     Gabapentin treatment for alcohol dependence   "
194554|NCT00391729|"     The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2     mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.   "
194555|NCT00391742|"     In a randomized controlled trial, patients recruited in general practices and fulfilling     criteria for alcohol dependence, alcohol abuse, at-risk drinking or binge drinking will be     allocated to three conditions: (1) Stepped Care intervention (SC): up to 4 interventions     depending on the success of the previous intervention (assessed by alcohol consumption and     self-efficacy) which start with a minimal intervention (written feedback and manuals) and are     followed by more intensive interventions (counseling) in case of no success, (2) Fixed Care     intervention (FC): A fixed number of counseling sessions plus written feedback and manuals,     and (3) a control group (CG) booklet on health behavior. Outcome assessment will be conducted     in all three groups after 12 months. The hypothesis is that SC and FC do not differ in     effectiveness but SC is more economic.   "
194556|NCT00391755|"     To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor     agonist used for insomnia, as a migraine prophylactic agent.   "
194557|NCT00391768|"     The purpose of this study is to learn how to treat influenza in children less than 2 years of     age. Tamiflu®, the drug being studied, is approved for treatment of children 1 year of age     and older with influenza. Researchers want to learn more about the activity of Tamiflu® in     the body to determine a dose of that is safe, well-tolerated, and effective in young children     with influenza. Children less than 24 months of age with confirmed influenza will receive     Tamiflu® 2 times a day for 5 days. Older participants will be enrolled first and younger     children will be enrolled after the safety data is reviewed for older participants. Study     procedures include blood samples, swabs from inside the nose, and body and nervous system     evaluations. Participants may be involved in study related procedures for up to 37 days.   "
194558|NCT00391781|"     The aim of this study is to compare between body-temperature to room-temperature contrast     media used during hysterosalpingography. We hypothesize that warmed medium will reduce pain     associated with the procedure.   "
194559|NCT00391794|"     The purpose of this study is to evaluate the impact of an Early Stage Memory Loss Support     Group (ESSG) and Education Seminar (ES) on quality of life, mood, social support, distress     about memory loss, and interpersonal relationships of memory loss participants and their     caregivers.   "
194560|NCT00391807|"     This is a non-comparative study. The primary objective of the study is to assess the efficacy     of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are     to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of     the product.   "
194561|NCT00391820|"     Study 0038 compares the safety and effectiveness of an investigational drug, TD-5108 with     placebo (a sugar pill) for the treatment of chronic constipation.   "
194562|NCT00391833|"     We investigate the clinical efficacy of Panax ginseng in Alzheimer’s disease (AD).   "
194563|NCT00391846|"     The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms     and signs is more effective than treatment guided by clinical symptoms and signs alone in     patients with HF and left ventricular systolic dysfunction   "
194578|NCT00392041|"     The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other     symptoms of fibromyalgia. It is hypothesized that participants receiving eszopiclone will     report greater improvement in total sleep time, sleep quality, pain, fatigue, physical     functioning, and emotional distress than will those receiving placebo.   "
194579|NCT00392054|"     The purpose of this study is to determine whether catheter-based pulmonary vein isolation is     superior to antiarrhythmic drugs as first line therapy in patients with symptomatic     paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of     antiarrhythmic drugs.   "
194580|NCT00392067|"     To compare the efficacy and safety of two different dose combinations of LEO19123     (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of     patients with atopic dermatitis   "
194676|NCT00393393|"     That Hylan G-F 20 may act to protect cartilage from the expected degree of degradation over a     12 month period in subjects with moderate to marked osteoarthritis of the knee   "
194564|NCT00391859|"     Osteoarthritis (OA) is a major public health concern. Currently, there are at least 3 million     Canadians afflicted with this condition with a 50% increase predicted by 2020. It is     estimated that 85% of Canadians are afflicted with OA by age 70. As such, using the current     health care structure, it is doubtful that the health system can keep pace with this     increasing demand. Alternative health care delivery strategies must be investigated.      The purpose of this study is to assess if a pharmacist-initiated intervention for individuals     with knee pain with a high likelihood of knee OA will lead to an improvement in the quality     of care for these individuals.      We are hopeful that results of this study will show better management of knee osteoarthritis     by a pharmacist-initiated intervention (which means that it is the pharmacist who will start     the process for an intervention that includes exercise and an educational program when     compared to no intervention. If this is the case, by implementing the proposed intervention     program, subjects could be diagnosed earlier, the burden of illness on individuals could be     diminished through an appropriate intervention program, and economic savings could be     embraced.      Hypothesis: Community pharmacists can identify patients with likely knee OA and initiate a     multidisciplinary intervention that will improve quality of care and outcomes.   "
194565|NCT00391872|"     Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications     work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment     for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both     heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by     the formation of a blood clot in an artery that partially or totally blocks the blood supply     to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine     which drug, when either is used in conjunction with aspirin, is better at reducing deaths     from vascular causes, future heart attacks and/or strokes in patients with ACS.   "
194566|NCT00391885|"     This study compares the manual administration of propofol and remifentanil and their delivery     using a combined closed-loop anesthesia system, entropy of the EEG being the controller.   "
194567|NCT00391898|"     The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in     patients with Parkinson's disease and early wearing-off with levodopa   "
194568|NCT00391911|"     Rhabdomyolysis has many causes including trauma, muscle crush injuries, lack of blood supply     to an arm or leg, burns, seizures, drugs and hereditary disorders. Rhabdomyolysis causes the     breakdown of muscle cells and the release of a molecule called myoglobin. Myoglobin is very     harmful to the kidneys and can lead to kidney failure.      Continuous dialysis has been shown to remove the myoglobin molecule from the blood in     patients with rhabdomyolysis. N-Acetylcysteine (NAC) has been used in patients receiving     contrast dye for x-rays and has shown less worsening of kidney function compared to patients     not receiving NAC.      Early and aggressive treatment of patients with rhabdomyolysis with standard therapy,     continuous dialysis and a drug called N-acetylcysteine (NAC) may prevent the development of     acute kidney failure. Patients who develop kidney failure from this disorder are often     critically ill and have a much higher chance of not surviving than those who do not develop     kidney failure.      The purpose of this study is to determine if the use of NAC and Continuous Veno-Venous     hemo(dia)filtration (CRRT)early in the course of rhabdomyolysis (in addition to standard     therapy)decreases the chance of developing acute renal failure   "
194569|NCT00391924|"     The purpose of the study is to examine whether dehydroepiandrosterone (DHEA) administration     improves fatigue and general well-being in patients with systemic lupus erythematosus or     primary Sjögren's syndrome   "
194570|NCT00391937|"     The purpose of this study is to compare the articular surface replacement (ASR) prosthesis     placed by the conventional positioning method and the ASR prosthesis placed by 'computer     assisted surgery' (CAS) in variation between pre planned position of the femoral component     and the actual position of the femoral component of the prosthesis. The hypothesis is that     this variation is larger with the conventional positioning method than when CAS is used.   "
194571|NCT00391950|"     The purpose of this study is to see if giving zoledronic acid three times a year is as     effective as five times a year, in increasing bone strength in men with prostate cancer. All     participants will receive the active drug but half will receive drug every 6 months and the     other half will receive drug every 3 months. Both patient and doctor will know which     treatment a patient is receiving.      After 1 year of treatment bone strength will be measured with scans and compared to the     strength at the start of the study. All participants will stop receiving the drug after 1     year and will be seen back in the clinic, annually for another 2 years for follow-up.   "
194572|NCT00391963|"     To compare Bispectral index and entropy during maintenance of anesthesia   "
194573|NCT00391976|"     This study assessed time to recurrence of infection with Pseudomonas aeruginosa following     treatment of the initial infection with tobramycin nebuliser solution. The safety profile of     the initial tobramycin treatment was assessed during the first 3 months of the study and     patients were followed until the end of the study, month 27.   "
194574|NCT00391989|"     The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in     de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate.   "
194575|NCT00392002|"     To characterize the burden of disease in GERD patients of prescription therapy'   "
194576|NCT00392015|"     The purpose of this study is to determine whether a new investigational malaria vaccine is     safe, well tolerated and effective against experimental exposure to malaria when given to     healthy people with no previous exposure to malaria. The vaccine consists of a modified form     of a relatively common virus, adenovirus, that has been rendered incapable of replicating     itself and modified to deliver the malaria gene of interest to the body's cells allowing the     cell to manufacture the protein encoded by the gene and present it to the body's immune     system in a more natural and presumably effective way.   "
194577|NCT00392028|"     The aim of the study is to determine the penetration levels of ertapenem into bone tissues in     patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing     amputation, and to correlate theme to the concentration of the drug in blood and other soft     tissues   "
194772|NCT00397475|"     The purpose of this study is to determine the effect of a colecalciferol substitution in     dialysis patients on bone metabolism and immune system   "
194585|NCT00392132|"     The Infectious Disease Society of America has recently recommended that patients with Human     Immunodeficiency Virus (HIV) be screened for kidney disease on a regular basis. Screening     involves non-invasive urine and blood test and a screening program has already been initiated     here in the University of Mississippi HIV clinic. This study looks at the effect of this new     screening program. Our Hypothesis is that screening for kidney disease is a cost effective     and important addition to the care of patients with HIV.   "
194586|NCT00392145|"     This study will look at children with dehydration secondary to gastroenteritis requiring IV     rehydration and determine whether the proportion rehydrated after two hours is greater in the     children who receive rapid intravenous rehydration (RIVR) or in the children who receive     standard IV rehydration.   "
194587|NCT00392158|"     To compare manual administration of propofol and remifentanil and dual closed-loop using     bispectral index as the control variable during anesthesia   "
194588|NCT00392171|"     The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE     study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense     temozolomide (50 mg/m^2) for up to 12 months may overcome resistance and be effective in the     management of adult patients with malignant glioma who have failed following at least 2     cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200     mg/m^2).   "
194589|NCT00392184|"     The purpose of this study is to determine whether accelerated partial breast irradiation     (APBI) with multi-catheter brachytherapy is safe and effective.   "
194590|NCT00392197|"     The objective of this study is to examine the effects of aripiprazole on glucose metabolism     in schizophrenic patients without hyperglycemia and diabetes mellitus or any history thereof.   "
194591|NCT00392210|"     After gynecologic surgery, it may be difficult to void (urinate). This problem is usually     short-term with normal function returning within a few days to a few weeks. For this reason,     patients may require drainage of their bladder with a catheter immediately after surgery.     Currently in our office, we use two different tests to see how well you are able to urinate     and how quickly the catheter can be removed. The purpose of this study is to see which     voiding test is better after gynecologic surgery.   "
194592|NCT00392223|"     The primary objective is to evaluate the clinical efficacy of azithromycin microspheres     treatment in outpatients with moderate to severe inflammatory acne compared with first line     treatment minocycline after 8 weeks of therapy   "
194593|NCT00392236|"     This study will determine whether using a pager improves medication adherence in people with     schizophrenia.   "
194594|NCT00392249|"     Patients suffering from Schizophrenia and their families often suffer from poor care because     of ignorance about the disorder especially in economically developing countries. Although     antipsychotic medication is effective in reducing relapse rate, 30-40 percent of patients     relapse within one year and 40-60 percent relapse within 2 years after discharge from 1st     hospitalization even if they are receiving maintenance medication.      Although antipsychotic medications are the mainstay of the treatment for schizophrenia,     patients with schizophrenia benefit more from combined use of antipsychotic drugs and     psychosocial treatment than pharmacotherapy alone in delaying or preventing relapse or     reducing hospital days. It is also less costly than standard treatment and suitable for     psychiatric rehabilitation.      Although there are now a number of studies from western countries and a randomized controlled     trial from china which have led to increase enthusiasm about psychosocial treatment for     schizophrenia but question remains about comparative benefit of treatment methods and     additional methods of multiple treatment. In developing countries there is need for further     studies in which integrated treatment of pharmaco-therapy and psycho-education is instituted     and compared with treatment as usual.      Realizing the need for maintaining the compliance and continuity of treatment, department of     psychiatry has started a program called Supervised Treatment of Outpatient Schizophrenia.     This study aims to evaluate the effectiveness of Supervised Treatment versus the usual care     provided in the outpatient.   "
194595|NCT00392262|"     The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in     hypertensive patients not responding to treatment with amlodipine or felodipine alone.   "
194596|NCT00392275|"     Based on previous results with eyes without filtering blebs, the aqueous concentrations of     ofloxacin and levofloxacin will exceed the concentration of ciprofloxacin after either     topical or topical plus oral administration.   "
194597|NCT00392288|"     Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg     twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.      Secondary objective: To assess the safety and tolerability of ciclesonide.   "
194598|NCT00392301|"     The purpose of this research study is to discover whether instruments widely used in skin     research can be used to measure wound healing in split thickness skin graft donor sites and     whether these instruments can detect differences in healing when two different dressing     products are used.   "
194599|NCT00392314|"     Recently published studies demonstrated very high event free survival for patients with a     normal interim PET/CT and a high hazard ratio for progression of an interim positive     (pathological)study. These findings strongly support the integration of interim PET as a     decision point for adjustment of chemotherapy.This study use the minimal therapy considered     safe according to the predefined risk factors for patients with interim negative PET. Those     with pathologic interim study considered as higher risk patients will have dose escalation of     therapy.remission rate ,event free survival and overall survival will be evaluated.   "
194601|NCT00392340|"     RATIONALE: Drugs used in chemotherapy, such as topotecan, vincristine, and doxorubicin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving topotecan together with vincristine     and doxorubicin works in treating young patients with refractory stage 4 neuroblastoma.   "
194719|NCT00393952|"     The purpose of this study is to compare the efficacy and safety of the fixed combination     asthma drug FlutiForm with its two components administered alone, fluticasone propionate and     formoterol fumarate, and with placebo in adult and adolescent patients with moderate to     severe asthma.   "
194720|NCT00393965|"     Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.   "
194602|NCT00392353|"     This phase I/II trial studies the side effects and best dose of vorinostat and azacitidine     and to see how well they work in treating patients with myelodysplastic syndromes or acute     myeloid leukemia. Vorinostat may stop the growth of cancer or abnormal cells by blocking some     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work     in different ways to stop the growth of cancer or abnormal cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving vorinostat     together with azacitidine may kill more cancer or abnormal cells.   "
194603|NCT00392366|"     The purpose of this study is to determine if the, MR guided, laser interstitial thermal     therapy (LITT) treatment technique can be safety and efficiently used for the human liver     metastasis   "
194604|NCT00392379|"     This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The     independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching     placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6     months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or     matching placebo.   "
194605|NCT00392392|"     This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and     carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers     demonstrating HER2 gene amplification. It is hoped that this novel combination will result in     increased pathologic response rates that will translate into long term outcome improvements     in HER2 positive patients with locally advanced breast cancer.   "
194606|NCT00392405|"     This will be a randomized controlled trial closely following the original protocol in the     previous study published in JAMA 2004 by Merten et al. Patients will be randomly assigned to     one of two treatment groups. Treatment group A will receive 1cc/kg/hour of 0.9% normal saline     at least 2 hours prior to study beginning and will be continued during and for 6 hours post     contrast. Treatment group B will receive 3cc/kg of sodium bicarbonate solution for one hour     prior to procedure then drip rate will be decreased to 1cc/kg/hour during and for 6 hours     post procedure. The sodium bicarbonate solution will be made by adding 3 amps of bicarbonate     to 1L of D5W. Patients in both treatment arms weighing >110kg the initial fluid bolus and     drip will be limited to those patients weighing 110kg. In both treatment arms, diuretics will     be held before and after contrast administration on the day of the study. BMP will be checked     the day of, 24 and 48 hours post contrast administration. The greatest change in all readings     will be used for treatment comparisons. Contrast induced nephropathy will be defined as a     change in serum creatinine of more than 25% from baseline and/or 0.5mg/dL. Urinary pH will     also be measured on first spontaneous void following bolus. Vital signs including blood     pressure and oxygen saturation will be documented every 4 hours to monitor patients closely     for signs and symptoms of volume overload   "
194607|NCT00392418|"     Millions of people worldwide are affected by iron deficiency anemia (IDA). IDA is a     widespread serious public health problem, especially for infants in developing countries     mainly because of inadequate intake of iron due to the poor bioavailability of dietary iron     in predominately cereal based diets. One of the ways to combat iron deficiency anemia is by     supplementation to targeted populations. Although iron drops have been used, they have been     largely unsuccessful in reducing the prevalence of anemia because of compliance, distribution     and supply issues. Sprinkles® are a new approach to iron delivery that is as efficacious as     iron drops and more acceptable. For Sprinkles® to be implemented into nation-wide programs as     a sustainable alternative to current iron supplementation approaches, an optimal model of use     and distribution for Sprinkles® needs to be established. By comparing daily versus flexible     use of Sprinkles® (60 sachets over 60, 90 and 120 days) among infants and young children aged     6-24 months, the primary objectives are to study the effect of the three administration     models of Sprinkles® on changes in:        1. hemoglobin concentration; and        2. compliance or adherence to the intervention.      ii. The secondary objective of this study is to determine the acceptability of each of the     three intervention models.      We hypothesize that adherence will be greater and hemoglobin concentration response will be     higher in those given 'flexible' instructions to use all of the Sprinkles® supplied over a     specific period of time compared to those given strict instructions for daily use.   "
194608|NCT00392431|"     Our hypothesis is that episodic amiodarone treatment (i.e. amiodarone treatment 1 month prior     until 1 month after cardioversion) is associated with a lower morbidity and a higher quality     of life compared to continuous prophylactic amiodarone treatment while atrial fibrillation is     still effectively suppressed. The latter means that at the end of the study permanent atrial     fibrillation is prevented in comparable percentage of patients (70%) in both treatment     strategies. However, this will be accomplished at the cost of a higher number of electrical     cardioversions (2-3) in the episodic treatment group compared to the continuous treatment     group.   "
194609|NCT00392444|"     This phase II trial is studying how well sunitinib works in treating patients with advanced     malignant mesothelioma of the pleura. Sunitinib may stop the growth of tumor cells by     blocking some of the enzymes needed for their growth.   "
194610|NCT00392457|"     The purpose of the research study is to learn more about the regulation of reproductive     hormones in adult men. We would like to understand what role testosterone and estradiol play     in controlling the release of LH (lutenizing hormone) and FSH (follicle stimulating hormone).     Testosterone and estradiol come from the testes, and LH and FSH are released from a gland in     the head called the pituitary.      Men involved in the study will have detailed evaluations that involve overnight stays in the     hospital and frequent blood sampling. The men in the study will also be receiving medications     that affect the levels of various hormones in the body. This will allow the researchers to     learn how various hormones influence each other. Men that participate in the study will     receive medical evaluations and monetary compensation. Information gathered from this study     will help in the development of new treatments for infertility and potentially new hormonal     forms of contraception.   "
194721|NCT00393978|"     The objectives of this study are to determine whether this treatment may be useful for     reducing cannabis consumption; reducing symptoms of bipolar mania; and weight mitigation     therapy for individuals on psychopharmacotherapy.   "
194722|NCT00393991|"     The purpose of this study is to compare the efficacy and safety of the fixed combination     asthma drug FlutiForm HFA MDI with its two components administered alone, fluticasone     propionate and formoterol fumarate, and with placebo in adult and adolescent patients with     mild to moderate asthma.   "
194611|NCT00392470|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in     chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances     to them. Giving radiation therapy together with irinotecan and cetuximab before surgery may     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when     given together with cetuximab and radiation therapy in treating patients who are undergoing     surgery for stage III or stage IV rectal cancer.   "
194612|NCT00392483|"     The evaluate the use and diffusion of an E-learning programme in Diagnostic Evaluation of     Dementia among General Practitioners (GPs) in Denmark.      The hypothesis are:        1. The GPs do not use the guided instructions        2. The GPs using the programme are more frequently younger GPs.        3. GPs working in rural areas will use the programme more frequently   "
194613|NCT00392496|"     This phase II trial is studying how well sunitinib works in treating patients with relapsed     or refractory diffuse or mediastinal large B-cell lymphoma. Sunitinib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood     flow to the cancer.   "
194614|NCT00392509|"     This study will treat patients with such severe lower leg ischemia or vascular compromise     that they have pain at rest. The goal is to compare treatment of the patient's painful     disorder by injecting cells into the calf of the leg and testing for circulatory improvement.     A treatment will given at random to two groups and will be injection into the calf muscle     with ALD-301 (specially processed stem and progenitor cells) from the patient's own bone     marrow, or with cells processed by more routine that minimally purifies the cells. The study     goal is to see if the ALD-301 cells are more effective in generating new small blood vessels     to improve the circulation to the affected leg.   "
194615|NCT00392522|"     Fiberoptic bronchoscopy may generate pain, anxiety or cough and dyspnea. It may then induce     discomfort and then run down its yield. Systematic local anaesthesia does not always suffice     and FOB may be conducted under general anaesthesia. Premixed nitrous oxide and oxygen (MEOPA)     could be efficient to avoid general anesthesia risks and to reduce organizational costs.     Nitrous oxide induces anaelgesia and anxiolysis when administered in oxygen at a 50%     concentration.      MEOPA is being delivered in France for every short painful medical in-patients procedure     since 2001. At a concentration of 50% in oxygen, and delivered through a facial mask, it     produces a conscious sedation useful during endoscopy. MEOPA safety is due to its short term     effect, which ends 5 minutes after cessation of inhalation. It therefore allows ambulatory     medicine.      Two randomized double blind controlled studies were driven in fiberoptic bronchoscopy     (Fauroux 2004, Atassi 2005) and showed its efficacy on pain control and sedation.      We will perform our Study to estimate MEOPA efficacy in term of pain control (Visual Analogic     Scale (VAS)), anxiety control (COVI Scale), cough and number of general anaesthesias,     comparing FOB under MEOPA and Oxygen (double blind, randomized, placebo-controlled study.   "
194616|NCT00392535|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet     known which schedule of intensity-modulated radiation therapy is more effective in treating     patients with prostate cancer.      PURPOSE: This randomized phase III trial is studying the side effects of three schedules of     intensity-modulated radiation therapy and compares how well they work in treating patients     with localized prostate cancer.   "
194617|NCT00392548|"     Study of the urinary vascular endothelial growth factor (VEGF) levels in patients with     glioblastoma, receiving standard therapy.      Hypothesis: that urinary VEGF levels can serve as a predictor of treatment response and     survival.   "
194618|NCT00392561|"     The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in     preventing non-melanoma skin cancers.   "
194619|NCT00392574|"     The objective of this pivotal Phase III study is to investigate the safety and efficacy of     prulifloxacin versus placebo in the treatment of subjects with acute bacterial     gastroenteritis.   "
194620|NCT00392587|"     The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess     its affects on their COPD disease after 14 days.   "
194621|NCT00392613|"     The investigators hypothesis is that in patients with permanent AF lenient rate control is     not inferior to strict rate control in terms of cardiovascular mortality, morbidity,     neurohormonal activation, NYHA class for heart failure, left ventricular function, left     atrial size, quality of life and costs. Lenient rate control is defined as a resting heart     rate <110 bpm.Strict rate control is defined as a mean resting heart rate < 80 beats per     minute (bpm) and heart rate during minor exercise < 110 bpm. Patients will be seen after 1,     2, 3 months (for titration of rate control drugs) and thereafter yearly.   "
194622|NCT00392639|"     According to international guidelines, mild therapeutic hypothermia is recommended for     resuscitated patients after cardiac arrest due to ventricular fibrillation. Whether external     or internal cooling is superior in terms of prognosis or security remains unknown. The aim of     this study is to evaluate in a randomized trial the clinical and economical interests of the     endovascular cooling versus the conventional external cooling for the management of     hypothermia after cardiac arrest.   "
194623|NCT00392652|"     This randomized phase I trial is studying the side effects and best dose of diindolylmethane     in healthy volunteers. Chemoprevention is the use of certain drugs or substances to keep     cancer from forming, growing, or coming back. The use of diindolylmethane may keep cancer     from forming. Collecting and storing samples of blood and urine from healthy volunteers to     study in the laboratory may help doctors learn more about the way a person's body handles the     drug.   "
194825|NCT00398190|"     The purpose of this project is to determine if a 3-session anti-smoking media literacy based     intervention is more effective that a standard 3-session anti-smoking media literacy     intervention at changing students' intention to smoke, actual smoking behavior, attitudes and     norms regarding smoking, and level of media literacy.   "
194624|NCT00392665|"     The main purpose of this research study is to collect information to learn how effective     erlotinib (tarceva) is in combination with either bevacizumab or sulindac in treating     patients with squamous cell carcinoma of the head and neck. Erlotinib and bevacizumab are     targeted therapy drugs that can control tumor growth by targeting specific abnormalities     sometimes found on cancer cells. Erlotinib targets epidermal growth factor receptor (EGFR),     and bevacizumab targets vascular endothelial growth factor (VEGF). Sulindac is a     non-steroidal anti-inflammatory drug (NSAID) that can block G protein-coupled receptor which     laboratory evidence shows is associated with both cancer cell growth and EGFR activity. The     bevacizumab being administered in this study is not a commercially marketed formulation of     the drug. Previous research with head and neck cancer suggest that erlotinib alone has some     anti-cancer activity. This research study is designed to see how well erlotinib works in     combination with bevacizumab or sulindac in head and neck cancer.   "
194625|NCT00392678|"     Growing evidence over recent years supports a potential role for low grade chronic     inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we     will determine whether salsalate, a member of the commonly used Non-Steroidal     Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2     diabetes. The study will determine whether salicylates represent a new pharmacological option     for diabetes management. The study is conducted in two stages. The first stage is a dose     ranging study, administering salsalate compared to placebo over three months. The primary     objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar     control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes     (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and     cardiac risk.      The second stage is a second trial and posted under alternate registration.   "
194626|NCT00392691|"     RATIONALE: Giving chemotherapy drugs, such as melphalan, before an autologous stem cell     transplant helps stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Also, monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan     and rituximab, can find cancer cells and carry cancer-killing substances to them without     harming normal cells. Chemotherapy and monoclonal antibody therapy also prepares the     patient's bone marrow for the stem cell transplant. Giving colony-stimulating factors, such     as G-CSF, and vinorelbine helps stem cells move from the bone marrow to the blood so they can     be collected and stored. The stem cells are returned to the patient to replace the     blood-forming cells that were destroyed by the chemotherapy and monoclonal antibody therapy.      PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when     given together with yttrium Y 90 ibritumomab tiuxetan and rituximab followed by autologous     stem cell transplant in treating older patients with non-Hodgkin's lymphoma that has relapsed     or not responded to previous treatment.   "
194627|NCT00392704|"     Two new cancer treatment drugs called targeted therapies will be added to standard treatment     for head and neck cancer to see if an improvement can be made in the effectiveness of     treatment for this type of cancer. Treatment will include chemotherapy, radiation therapy and     targeted therapy taken over a period of 4 months.   "
194628|NCT00392717|"     Visceral obesity is strongly associated with dyslipidaemia (hypertriglyceridaemia, low     HDL-cholesterol and mildly elevated LDL-cholesterol) and insulin resistance, key     characteristics of metabolic syndrome (MetS). Recent evidence has clearly established that     the risk of CVD is increased in subjects with the MetS. The precise reason for this remains     unclear, but appears to be closely related with dyslipidaemia. Effective management of     dyslipidaemia is important to reduce the risk of CVD in these subjects.      Hypothesis: Inhibition of hepatic cholesterol synthesis by statins and triglyceride synthesis     by fish oils improve lipoprotein metabolism in visceral obese men.   "
194629|NCT00392730|"     Manganese (Mn) is an essential metal required for normal growth and development. However,     exposure to high Mn levels can be toxic to the brain. The objectives of this project are to     identify neonatal and young pediatric populations that are at increased risk of excessive     brain Mn deposition and altered cognitive and motor development based on their dietary     parenteral Mn exposure, and to make sound and evidence-based recommendations for appropriate     Mn supplementation and monitoring of infants and young children receiving parenteral     nutrition (PN). Our studies are designed to test the hypotheses that, compared with unexposed     age-matched controls, infants and young children receiving prolonged Mn-supplemented PN will     have increased deposition of Mn in their brains and lower scores on neurodevelopmental,     cognitive and psychophysiological assessments.   "
194630|NCT00392743|"     A direct comparison of Positron Emission Tomography (PET) (11C-Raclopride) and Single Photon     Emission Computed Tomography (SPECT) (123I-IBZM) D2 RO measurements would allow GSK to gain     understanding on the SPECT results obtained with SB773812, and to accurately interpret future     D2 RO results from either PET or SPECT studies with new compounds.   "
194645|NCT00392938|"     RATIONALE: Imaging procedures, such as PET scan, may help doctors predict a patient's     response to treatment and help plan the best treatment.      PURPOSE: This clinical trial is studying carbon-11 acetate and fludeoxyglucose F 18 PET scan     of the bone in patients with metastatic prostate cancer that has spread to the bone.   "
194632|NCT00392769|"     The goal of this clinical research study is to learn if cetuximab can help to control the     disease in patients who have recurrent endometrial cancer.      Primary Objective:      1. To determine the overall disease control rate of cetuximab in patients with progressive or     recurrent endometrial cancer.      Secondary Objectives:        1. To determine the duration of disease control, time to disease progression, and survival          of this cohort of patients.        2. To determine the nature and degree of toxicity of cetuximab in this cohort of patients.        3. To correlate biologic markers with response to therapy if tissue is available.   "
194759|NCT00394394|"     The majority of hypertensive patients require antihypertensive associations to control their     blood pressure. Most of clinical trials don’t compare different associations using     Hydrochlorothiazide 25 mg as the standard initial therapy and compare the associations using     doses that are not equivalent.      This randomized trial where patients and investigators are blinded and compares the     effectiveness two associations: Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and     Enalapril.   "
194826|NCT00398203|"     To assess the efficacy of the NaviAid™ BGE Device, while used in conjunction with a standard     endoscope for the diagnosis and treatment of the small intestine.   "
194633|NCT00392782|"     RATIONALE: Giving total-body irradiation and chemotherapy, such as fludarabine and thiotepa,     before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It     also helps stop the patient's immune system from rejecting the donor's stem cells. When     healthy stem cells from a donor are infused into the patient, they may help the patient's     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving antithymocyte globulin and removing the T cells from the donor cells before transplant     may stop this from happening.      PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in     treating patients with myeloid cancer or other disease.   "
194634|NCT00392795|"     The primary purpose of this proposal will be to identify potentially modifiable risk factors     of long-term cognitive impairment (i.e. development of delirium and exposure to sedative and     analgesic medications) in ICU patients. The investigators will quantify the independent     contribution of these risk factors to the incidence of long-term cognitive impairment,     controlling for other established risk factors including age, pre-existing cognitive     impairment, and apolipoprotein E (apoE) genotype. Quantifying the contributions of these     modifiable risk factors will pave the way for the development of preventive and/or treatment     strategies to reduce the incidence, severity and/or duration of long-term cognitive     impairment and improve functional recovery for patients with critical illness.   "
194635|NCT00392808|"     The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in     the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to     assess the interchangeability of the two different vaccines.   "
194636|NCT00392821|"     This study is being done in 2 parts. The first part is to determine the dose of RAD001 that     should be used in combination with sorafenib. The second part is using the above determined     dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against     advanced kidney cancer.      Participants will be asked to keep a pill diary.   "
194637|NCT00392834|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving rituximab together with combination chemotherapy may kill more     cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with combination     chemotherapy works in treating patients with newly diagnosed, HIV-associated Burkitt's     lymphoma.   "
194638|NCT00392847|"     Child psychological/behavioural disorders such as withdrawal may persist when the     psychosocial context is unfavourable. Health promotion strategies (Olds' paradigm) have     proved their efficacy in vulnerable populations. CAPEDP project sets out to evaluate a     program of home visits in France   "
194639|NCT00392860|"     The purpose of this study is to test the effectiveness of newly designed ergonomic manual     wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard     handrim. It is our hope that the new design of the handrims will help reduce upper extremity     pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim     was designed to directly address the shortcomings of standard handrims and to improve the     standard-round tube handrims which were designed over 50 years ago. The PalmRim was designed     for individuals who have limited hand function, making it difficult to grasp standard     handrims.   "
194640|NCT00392873|"     The purpose of this study is to examine the effects of increased food intake on the menstrual     cycle and bone health in physically active women who have irregular or absent menstrual     cycles. This study will examine whether a 12 month period of increased food intake will cause     menstrual cycles to resume and help bones get stronger.   "
194641|NCT00392886|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. A bone marrow or     peripheral stem cell transplant using stem cells from the patient may be able to replace     blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to     be given so that more tumor cells are killed.      PURPOSE: This phase III trial is studying how well giving combination chemotherapy with or     without etoposide followed by an autologous stem cell transplant works in treating young     patients with previously untreated malignant brain tumors.   "
194642|NCT00392899|"     RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.     Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this     case, observation may be sufficient. It is not yet known whether chemotherapy is more     effective than observation in treating colorectal cancer.      PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they     work compared to observation in treating patients with stage II colorectal cancer that has     been completely removed by surgery.   "
194643|NCT00392912|"     Treatment with testosterone can improve performance on tests of spatial ability in men with     low testosterone levels and Alzheimer's disease. Improved performance on these tests may mean     an improved ability to get around in one's environment without getting lost or injured. This     could have a positive impact on both patients and those who care for them. We will     investigate what areas of the brain are involved in these improvements in spatial ability.     This will be done using a PET scan, which creates a 3-dimensional image of the brain that can     allow us to see how the brain functions.   "
194644|NCT00392925|"     This study will evaluate the safety, tolerability, and effect on body weight of leptin,     injected subcutaneously, in combination with pramlintide, injected subcutaneously.   "
194827|NCT00398216|"     This study is to assess if DU176b is effective in prevention of blood clots following hip     replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up     visits.   "
194889|NCT00399048|"     The purpose of this study was to characterize the effectiveness and safety of OROS     hydromorphone HCL and OxyContin in patients with chronic osteoarthritis (OA) of the knee or     hip who are receiving chronic nonsteroidal anti-inflammatory drug (NSAID) or other     nonsteroidal, non-opioid analgesic (ie, acetaminophen or aspirin) therapy.   "
194646|NCT00392951|"     Treatment for patients with autoimmune destruction of blood cells is poor. The part of the     body that fights infections is called the immune system and white blood cells (WBCs) are part     of the immune system. Normally, a person's body creates WBCs to fight infections and     eliminates WBCs which have stopped helping the body function. Patients with autoimmune     destruction of blood cells have difficulty eliminating old WBCs. The abnormal WBCs build up     and can damage other healthy cells, which can lead to anemia, fatigue, jaundice, internal     bleeding, infection, and cancer. Few effective medications exist for treatment for patients     with autoimmune cytopenias and those commonly used are fraught with side effects.     Nevertheless, as scientific understanding of autoimmune diseases has improved, more directed     and less toxic therapies are becoming available. A number of groups have been studying the     efficacy of a medication called sirolimus in patients with autoimmune diseases. This medicine     has been FDA-approved for over 20 years. Sirolimus is a medicine used in children with other     diseases. Sirolimus works, in part, by eliminating old and abnormal WBCs. Our group and     others have shown that sirolimus is effective in mice with autoimmunity and in children with     a rare condition called Autoimmune Lymphoproliferative Syndrome (ALPS). We believe sirolimus     will help children with autoimmune cytopenias. We believe it will improve their symptoms and     make them less sick. We propose to study sirolimus in children with chronic and/or refractory     autoimmune cytopenias.   "
194647|NCT00392964|"     There is substantial, continuing, and unexplained rise in prescribing of proton pump     inhibitors. It is unknown whether their use in practice has corresponded to their licensed     indications.      Although the indications for H2RA or PPI administration in the treatment of acid-related     diseases and the prevention of gastric mucosal damage have been well defined in the medical     literature, the perception of benefit from their use frequently tends to be extrapolated to     all patients in general, leading to an excessive consumption of these drugs in general     practice.      To date, however, little has been published with regard to the overall use or misuse of these     drugs in hospital populations in ischemic heart disease patients as a secondary prevention to     Aspirin use.      We will undertake a 6-months retrospective survey (about 1200 patients) to evaluate the use     of acid-suppressive medications in the general internal medicine ward of Rambam Hospital.      We will extract all records of prescribing of a proton pump inhibitor within Rambam Hospital     computerized patients file program (Premetheuos) in period of half year, categorized and     analyze them using statistical X2 test.   "
194648|NCT00392977|"     Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse     neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased     risk of Mn neurotoxicity because neonatal PN solutions contain high concentrations of Mn.     This proposal will investigate brain deposition of Mn, a paramagnetic element, by magnetic     resonance (MR) imaging in preterm and term neonates receiving Mn-supplemented PN and     gestational age-matched control infants. The goals of this project are to identify neonatal     populations that are at increased risk of excessive brain Mn deposition based on their     gestational age, iron status, hepatic function and dietary Mn intake, and to make     evidence-based recommendations for appropriate Mn supplementation and monitoring of infants     receiving PN.   "
194649|NCT00392990|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Giving rituximab     together with combination chemotherapy may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome     and rituximab together with combination chemotherapy works in treating patients with newly     diagnosed Burkitt's lymphoma or Burkitt-like lymphoma.   "
194650|NCT00393003|"     This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia     system during the postoperative period.   "
194651|NCT00393029|"     Background:      The p53 gene normally suppresses tumor growth, but when it is mutated, or damaged, tumors can     grow unchecked.      In cancers where the p53 gene has mutated, an increased level of p53(overexpression of p53)     can be measured in the tumor.      Objectives To determine whether advanced cancers that overexpress p53 can be treated     effectively with lymphocytes (white blood cells) that have been genetically engineered to     contain an anti-p53 protein.      Eligibility Patients 18 years of age and older with metastatic cancer (cancer that has spread     beyond the original site) Patient's tumor overexpresses p53 Patient's leukocyte antigen type     is HLA-A 0201 Design      Patients undergo the following procedures:      Leukapheresis (on two occasions). This is a method of collecting large numbers of white blood     cells. The cells obtained in the first leukapheresis procedure are grown in the laboratory,     and the anti-p53 protein is inserted into the cells using an inactivated (harmless)virus in a     process called transduction. Cells collected in the second leukapheresis procedure are used     to evaluate the effectiveness of the study treatment.      Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) for 1 week     to suppress the immune system so that the patients immune cells do not interfere with the     treatment.      Treatment with anti-p53 cells. Patients receive an IV infusion of the transduced cells     containing anti-p53 protein, followed by infusions of a drug called IL-2, which helps boost     the effectiveness of the transduced white cells.      Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue). Patients are     evaluated with laboratory tests and imaging tests, such as computed tomography (CT) scans 4     to 6 weeks after treatment and then once a month 3 to 4 months to determine the response to     treatment.      Patients have blood tests at 1, 3, 6 and 12 months and then annually for the next 10 years.   "
194652|NCT00393042|"     The purpose of this study is to evaluate how children and adolescents with Attention Deficit/     Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant     medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is     to evaluate if there are differences in sleep and other side effects, such as changes in mood     or loss of appetite, which can occur with stimulant medications. A third purpose is to     determine if there are differences in the characteristics of individuals who respond better     to either of the medications.      This research is being done because the investigators do not know if one of these two     commonly used treatments is better tolerated than the other. Children and adolescents with     ADHD often have a hard time sitting still, playing quietly, finishing things they start,     paying attention, waiting their turn, and not distracting others. These medications improve     these symptoms, but sometimes affect sleep, appetite, or mood.      It is hypothesized that at effective and frequently prescribed doses, Adderall will be     associated with insomnia, more stimulant side effects, and decreased tolerability during an     acute trial relative to Focalin.   "
194653|NCT00393055|"     The purpose of the trial is to determine the extent to which daily use of xylitol lozenges     reduces the appearance of new caries lesions in adults who tend to experience such lesions     (i.e., caries-active adults).   "
194655|NCT00393094|"     Background:        -  Bevacizumab is a genetically engineered antibody that blocks the growth of new blood          vessels in tumors. It has shown activity against human brain tumors in laboratory tests          and human clinical trials.        -  Irinotecan causes damage to the deoxyribonucleic acid (DNA) in cancer cells so that the          cells cannot reproduce or repair themselves. It is approved for treating patients with          colorectal cancer.        -  Bevacizumab and irinotecan in combination are more effective against colon cancer than          either drug alone.      Objectives:        -  To determine the safety of bevacizumab and irinotecan and any side effects associated          with the combination of the two drugs when given to patients with high grade gliomas.        -  To determine if the combination of bevacizumab and irinotecan can help patients with          brain tumors that have grown after treatment with bevacizumab alone.      Eligibility:      -Patients 18 years of age and older who have been treated on National Cancer Institute (NCI)     trial 06-C-0064 (NCT00271609), Bevacizumab Alone for Recurrent Gliomas, and whose tumor has     progressed.      Design:      Participants receive infusions of bevacizumab and irinotecan through a vein once every 2     weeks in 4-week treatment cycles, plus the following procedures:        -  History, physical and neurological examinations every 2 weeks for the first treatment          cycle and then every 4 weeks        -  Magnetic Resonance Imaging (MRI) scan of the head every 4 weeks.        -  Routine lab every week.        -  Quality-of-life questionnaire every 4 weeks   "
194656|NCT00393107|"     Purpose of this study was to assess the safety profile and the anti-lymphoma activity of the     FC+R combination.   "
194657|NCT00393120|"     This study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist     INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not     currently on a HAART regimen and have not received any antiretroviral agents for 3 months     prior to the Screening visit. Subjects will receive study medication (INCB009471) admnistered     orally or placebo once daily with food for 14 days. Clinical safety laboratories, 12-lead     electrocardiograms, physical examinations and virologic assessments, including viral load,     viral tropism and CD4+ cell count determinations will be performed at the Screening visit and     at regularly scheduled visits throughout the study. A blood sample will also be obtained and     stored to potentially determine the genotype of the CCR5 receptor.      The primary objectives are:        1. Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered          orally, once daily, as monotherapy for 14 days;        2. Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered          orally, once daily, as monotherapy for 14 days;        3. Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when          administered orally, once daily, as monotherapy for 14 days   "
194658|NCT00393146|"     This study is designed to look at the safety, tolerability and effectiveness of 28 days of     dosing of GW856553 in rheumatoid arthritis patients.   "
194659|NCT00393159|"     This study is designed to check the effect of the use of the ear popper device on serous     otitis media in children and on the conductive hearing loss accompanying the otitis. It is     intended that 30 children aged 3-18 years will participate in the study. The inclusion     criteria are : clinical serous otitis media for a duration of more then 3 months, a     conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C.     The children will use the ear popper for 7 weeks. They will undergo otologic examination,     audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from     the beginning of the trial. The otologic findings and the audiometry and tympanometry results     before and after the trial will be compared. We will try to determine whether the use of the     ear popper in the test group will improve the conductive hearing loss and prevent the need     for tympanostomy tube insertion.   "
194660|NCT00393172|"     RATIONALE: Exercising regularly may lower the risk of breast cancer.      PURPOSE: This randomized clinical trial is studying how well exercise prevents breast cancer     in healthy young women.   "
194661|NCT00393185|"     This disease is believed to be due to immune cells, cells which normally protect the body,     but are now destroying the bile ducts in the liver. When the ducts are damaged, bile builds     up in the liver and damages liver tissue. Over time, the disease can cause cirrhosis and may     make the liver stop working. This study is designed to examine whether treating patients with     high dose Cyclophosphamide and Fludarabine (drugs which reduce the function of your immune     system) and CAMPATH-1H (a protein that kills the immune cells that are thought to be causing     PBC), followed by return of blood stem cells that have been previously collected from patient     brother or sister will stop or reverse the disease. The purpose of the Cyclophosphamide,     Fludarabine and CAMPATH-1H is to decrease immune system. The purpose of the stem cell     infusion is to restore blood production, which will be severely impaired by the     Cyclophosphamide, Fludarabine and CAMPATH-1H, and to produce a normal immune system that will     no longer attack the body.   "
194662|NCT00393198|"     The purpose of this study is to assess the bleeding pattern during the last 3 months of the     first MIRENA® and the first year of the second MIRENA® use.   "
194663|NCT00393211|"     Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back     pain.   "
194677|NCT00393406|"     Lifestyle behaviors among women with a family history of breast cancer are likely to be     influenced by a number of factors, including both objective risk factors and subjective risk,     or perceived risk. The aims of this mixed method study are twofold and will be explored     through both quantitative (i.e. secondary survey data) and qualitative data (i.e. personal     in-depth interviews) derived from the Sister Study, a large epidemiologic study being     conducted through the National Institute of Environmental Health Sciences, which is     addressing risk factors for breast cancer in sisters of women who have had breast cancer. The     quantitative aims include an exploration of lifestyle behaviors and behavioral differences     between White and African American women, as well as well as an exploration of the     relationships between lifestyle behaviors (i.e. varying levels of objective risk based on     Gail model risk scores, medical risk-reducing factors (i.e. use of Tamoxifen or Raloxifene     and/or prophylactic surgery), as well as additional factors that may be contributors to     perceived risk. This aim will be addressed using data that have already been collected as     part of the baseline activities for the Sister Study. The primary qualitative aim is to gain     a better understanding about perceived risk and the relationship between perceived risk and     lifestyle behaviors in both White and African American women with a family history of breast     cancer. This aim requires the collection of new data through in-person interviews with     between 28 and 40 women, depending on how many interviews are required to achieve data     saturation.      The mixed method approach will be based on a complementarity model, which emphasizes the     use of two different methods to address different aspects of the research problem. Results     from both methods will become integrated into the discussion of the findings and it is     expected that this approach will enrich the study and allow for elaboration of the     quantitative results. The secondary data analysis will be derived from approximately 10,000     women, initially enrolled in the Sister Study, who are between the ages of 35 and 74 and have     had at least one sister affected by breast cancer. Women for the qualitative interviews will     be recruited from a cohort of Sister Study participants residing within North Carolina and     will include equal numbers of both White and African American women. It is expected that 28     women will be needed for qualitative data saturati...   "
194664|NCT00393224|"     In an effort to identify genetic factors linked to the development of nasopharyngeal cancer     (NPC), the researchers identified and sampled 2,394 individuals from Taiwanese families in     which two or more relatives had been diagnosed with NPC. Serum from these individuals was     tested for three anti-Epstein-Barr virus (EPV) antibodies associated with elevated risk of     NPC. Results indicate that apparently healthy individuals from high-risk families have a     nearly threefold elevation in their EBV antibody prevalence compared with the general     population. However, the clinical implications of this finding are not yet understood.      To clarify the implications, the 2,394 unaffected individuals from the multiplex family study     will be invited to participate in the current study. Approximately 1,600 individuals are     expected to participate.      Participants will have an ear, nose, and throat examination to determine if they have occult     or symptomatic NPC. Their levels of EBV antibody at the time of initial recruitment will be     correlated with NPC detection in the period between initial recruitment and the present     study. Participants will also be asked to complete a brief risk factor questionnaire and to     donate blood, saliva, a nasopharyngeal swab, nasopharyngeal tissue, and urine for future     studies.      Currently, no accepted clinical management protocol exists for screening unaffected members     from families at high risk of NPC development. Results from this study have the potential to     significantly impact the clinical management and follow-up of individuals with a family     history of NPC.   "
194665|NCT00393250|"     This study will examine whether hypnosis can reduce the frequency and intensity of pain in     patients with sickle cell disease.      Patients 18 years of age and older with sickle cell disease and a history of pain associated     with their disease may be eligible for this study.      Participants are interviewed to assess their frequency and intensity of pain, sleep quality,     coping strategies, mood and anxiety and are then randomly assigned to study Group A or B (see     below). All participants are given pain diaries to complete at home and turn in at each     clinic visit. They undergo the following procedures:      Group A      Weeks 1-4: Receive weekly 60-minute hypnosis sessions, in which they are given suggestions     for relieving pain, reducing anxiety, improving sleep and enhancing their health and     well-being. The sessions are audio- and videotaped.      Week 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.      Week 6: Receive a DVD player and DVD with instruction on how to perform self-hypnosis. They     practice hypnosis at home as often as needed, but at least once a day. They record in a pain     diary in the morning and the evening their amount of pain, medication use, school or work     attendance, quality and amount of sleep and number of times they use self-hypnosis.      Weeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.      Week 12: Are assessed for how they respond to the hypnosis.      Group B      Weeks 1-4: Receive weekly 60-minute sessions of education about sickle cell disease.      Week 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.      Week 6: Turn in their daily pain diaries and receive a DVD player and DVD that contains     educational materials about sickle cell disease.      Weeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.      Weeks 13-24: Follow the procedures described in weeks 1-12 for Group A.   "
194666|NCT00393263|"     Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS     causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which     may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop     vulvar cancer.      The current gold standard treatment for lichen sclerosus is ultra-potent topical     corticosteroids. When properly administered, topical ultra-potent corticosteroids help to     resolve the symptoms of itching and burning and can prevent further vulvar scarring. In     addition, proper treatment reverses the underlying inflammation of LS, and preliminary data     shows that the risk of cancer also declines. While effective, topical corticosteroids have     serious local and systemic side effects that include thinning of the skin, superimposed     fungal infections, and suppression of the adrenal gland.      Elidel 1% cream is a new type of medication that has been approved by the FDA for the     treatment of eczema. In theory, Elidel should also treat LS without the serious side effects     that accompany corticosteroids. Therefore, this study is designed to compare the     effectiveness and safety of a topical corticosteroid (clobetasol) versus Elidel 1% cream for     the treatment of LS.   "
194667|NCT00393276|"     Infection with either HIV or hepatitis C virus (HCV) affects immune system responses. The     purpose of this study is to investigate the immune responses to two different vaccine     formulations in HIV-infected, HCV-infected, and HCV/HIV- coinfected individuals.   "
194668|NCT00393289|"     The purpose of the study is to determine the uptake of calcium from fish bone meal from     salmon and cod in 12 healthy volunteers. A test meal labelled with trace amounts of a     radioactive calcium isotope (Ca47) will be given after an overnight fast and whole body     retention of calcium will be measured on day 13, 21, and 24 after the test meal day.   "
194669|NCT00393302|"     Mother-to-child transmission of HIV is an important but preventable mode of infection.     Prevention depends on identifying pregnant women infected with HIV and offering medications     during pregnancy which can dramatically decrease the chances of transmission. Currently     universal screening of all pregnant women for HIV is recommended in the province of Ontario.     Unfortunately the rates of screening are still low: estimates place the average rate at 50%     -60%. We believe that rates in our clinic at the Women's Health Care Centre are significantly     higher in part because all our patients have a first obstetrical visit. This is an unhurried     visit with a trained obstetrical nurse who offers pre-test counselling and explores reasons     why patients refuse testing. We hypothesize that with this system, acceptance rates for HIV     screening are significantly higher than the provincial average.   "
194670|NCT00393315|"     The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting     PTCA-balloon in the treatment of in-stent restenoses in native coronary arteries with     reference diameters between 2.5 mm and 3.5 mm and ≤ 22 mm in length for procedural success     and preservation of vessel patency in comparison to the Paclitaxel-eluting Taxus™ stent.   "
194671|NCT00393328|"     The purpose of this clinical research study is to assess the bioequivalence of atazanavir     administered as a single 300 mg capsule relative to two atazanavir 150 mg capsules in healthy     subjects.   "
194672|NCT00393341|"     We propose to quantitate endothelial progenitor cells (EPCs) in early and advanced breast     cancer patients. Peripheral blood will be drawn from the eligible patients. Different type of     EPCs will be isolated from the blood and quantitated.   "
194673|NCT00393354|"     Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back     pain.   "
194674|NCT00393367|"     The purpose of this study is to determine whether the addition of budesonide inhalation     suspension (BIS) to the standard therapy of albuterol, ipratropium bromide, and systemic     corticosteroids (SCS) for moderate to severe asthma flares in children reduces asthma     severity more rapidly than standard therapy alone.   "
194675|NCT00393380|"     The purpose of this study is to determine whether the addition of parathyroid hormone after a     sequential cord blood transplant will improve engraftment, which is the ability of the     transplanted stem cells to grow and to successfully begin producing new blood cells.   "
194679|NCT00393432|"     This study will determine how the brain learns a new motor task when the subject practices     the task and watches others perform it (action observation) at the same time.      Healthy normal volunteers between 18 and 55 years of age may be eligible for this study.     Candidates are screened with a medical history, general and neurological exam, and a brain     MRI if one has not been done within 12 months of entering the study. Participants undergo one     or both of the following experiments:        1. Effect of Transcranial Magnetic Stimulation on Motor Training and Action Observation           Subjects participate in at least 12 4-hour test sessions, separated by at least 1 day.          Each session includes the following:             -  Functional MRI (fMRI): MRI scanning uses a magnetic field and radio waves to               produce images of the brain. For fMRI, the subject performs tasks during the scan               to allow researchers to see brain changes that occur during performance of the               activity.             -  Transcranial magnetic stimulation (TMS): For this test, a wire coil is held on the               scalp. A brief electrical current passes through the coil to stimulate the brain.               The stimulation may cause a twitch in muscles of the face, arm, or leg, and the               subject may hear a click and feel a pulling sensation on the skin under the coil.               During the stimulation, the subject is asked to: 1) perform the training task (make               brisk thumb movements); 2) watch a video showing the hand of another person               performing the same task; and 3) perform the task and watch the video at the same               time, synchronizing his or her movements with those observed in the video.             -  Surface electromyography: Electrodes are filled with a conductive gel and taped to               the skin over a hand muscle to measure the electrical activity of the muscle.             -  Behavioral measurements: Evaluation of learned movement tasks.             -  Questionnaires to test attention, fatigue and mood before, during and after each               test session.        2. Effect of Pharmacological Agents on Motor Training and Action Observation      Subjects participate in no more than 12 5-hour test sessions, separated by at least 2 days.     In the course of the 12 sessions, subjects receive each of three medications -     dextromethorphan, scopolamine and rivastigmine - three times and a placebo (pill with no     active ingredient) three times. During each session, subjects have TMS measurements,     behavioral measurements and electromyography as described in experiment 1.   "
194680|NCT00393445|"     The purpose of this study is to determine the dose of the GLP-1 receptor antagonist     exendin(9-39) which blocks the insulinotropic action of synthetic GLP-1 by at least 95%.   "
194681|NCT00393458|"     This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses     of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with     chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either     indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily,     or placebo.   "
194682|NCT00393471|"     To compare the therapeutic and radiographic effects and safety between etanercept,     methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid     arthritis.   "
194683|NCT00393484|"     Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B     DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain     reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100     mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus     infection.   "
194684|NCT00393497|"     The purpose of this study is to evaluate the effectiveness of bevacizumab in women with     lymphedema as a result of previous treatment for breast cancer.   "
194685|NCT00393510|"     Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent     elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super     imposed infections, all contribute towards the chronicity and failure of treatment.     Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer     that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like     to try all methods of healing before accepting amputation.      Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for     diabetic patients suffering from chronic foot ulcers may promote healing so that major leg     amputation can be avoided.   "
194686|NCT00393523|"     To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children     who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary     vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed     hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in     this study will be either an investigational Merck product (Modified Process Hepatitis B     Vaccine) or licensed ENGERIX-B vaccine.   "
194687|NCT00393536|"     The purpose of this study is to find out whether educational visits by Pharmacists, who are     already employed as advisers in health organisations, improve the prescribing habits of     primary care doctors.   "
194688|NCT00393549|"     The purpose of the study is to compare the performance of the NeuroPath automated nerve     conduction test with the standard of care manual test in the diagnosis of entrapment     neuropathies.   "
194689|NCT00393562|"     This is an open-label cross-over randomized control study comparing the effect of modafinil     and methylphenidate in patients with Parkinson's disease with excessive daytime sleepiness.   "
194690|NCT00393575|"     Connect to Protect (C2P): Partnerships for Youth Prevention Interventions is a multi-site,     three-phase project developed by the Adolescent Medicine Trials Network for HIV/AIDS     Interventions (ATN). The overall goal of the project is to ultimately reduce HIV incidence     and prevalence in youth 12-24 years old through a community mobilization intervention. This     protocol (ATN 040) describes part one of Phase III. Part two of Phase III will be submitted     as a separate protocol (ATN 041).   "
194691|NCT00393588|"     This study will test the ability of magnetic resonance imaging (MRI) to detect damage in     different parts of the brain in patients with multiple sclerosis and to see if cognitive     problems in patients can be correlated with the presence of lesions or reduction in the size     of certain part of the brain. Healthy subjects will also be studied to compare findings in     patients with those of normal volunteers.      Healthy subjects and patients with multiple sclerosis who are between 18 and 60 years of age     may be eligible for this study. Patients must not have severe clinical disability and must     have been receiving and responding to Interferon beta for at least 6 months prior to     enrollment. Candidates are screened with a medical history, physical examination, MRI and     possibly evoked potential testing, which measures the nervous system response to visual,     auditory and somatosensory stimulation.      Participants have two MRI scans within 1 week (inclusive of the one performed for screening).     MRI uses a magnetic field and radio waves to obtain images of body tissues and organs. The     scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, the     subject lies on a table that can slide in and out of the cylinder. Participants will be     tested with magnet strengths of 1.5 and 3 Tesla; the higher the Tesla, the greater the     ability to see brain changes. Each scan may last up to 90 minutes. In addition to the MRI     scans, participants undergo cognitive testing that measures memory and thought processes and     complete forms that test and quantify fatigue level, stress, anxiety and depression   "
194692|NCT00393601|"     The investigator intends to review retrospective de-identified data of patients who have had     Laparoscopic Radical Cystectomies by the Department of Urology at UCIMC.   "
194693|NCT00393614|"     In clinical practice at the National centre for epilepsy (SSE) in Norway we see many children     who have subclinical epileptiform activity in EEG that increases substantially during slow     wave sleep (SSEA; subclinical sleep-activated epileptiform activity). They may or may not     have seizures. Hence, according to the definition some children with SSEA do not suffer from     epilepsy because they do not experience seizures. Many of these children have symptoms such     as: attention deficit hyperactivity disorders (AD/HD), dyslectic problems, sleep problems,     tantrums or autistic symptoms . We hypothesize that this subclinical epileptiform activity     during slow sleep may act negatively on cognitive functions, language and behaviour in some     children; even when the spike-wave discharges are less frequent than in CSWS (continuous     spike-waves during slow sleep).   "
194694|NCT00393627|"     Sleep disturbances are widespread among demented residents of board and care homes and are a     leading cause for transfer into nursing homes. This study is a randomized controlled clinical     trial to evaluate the efficacy of a 4-week Sleep Education Program (SEP) for demented     residents of board and care homes who are experiencing sleep disturbances. Residents of adult     family homes (board and care homes with 2-6 residents) will be randomized into SEP or usual     care control. Analysis of outcomes will determine whether the SEP is feasible and effective     in adult family home settings, and whether the SEP delays transition into higher levels of     institutional care.   "
194695|NCT00393640|"     The purpose of this study is to determine whether early start of either breastfeeding or     breast milk expression may positively affect milk production later in lactation.      120 breastfeeding mothers will be recruited and randomized into 4 groups (2 groups with     preterm deliveries) and 2 groups with term deliveries. One group will be given a breast pump     to pump early and regularly. the second group will be encouraged to breastfeed in response to     baby's cues. Breast milk samples will be collected at the end of a week.   "
194696|NCT00393653|"     The purpose of this study is to evaluate whether a novel prescription method (N-of-1     intervention)can be successfully integrated into primary care practices and to examine the     effects of this prescription method on selected patient health outcomes (e.g.., medication     compliance, medication costs, symptom management, satisfaction of physician/patient visit,     etc.) in patients with a uncontrolled or new diagnosis of Osteoarthritis or Chronic Heartburn     (GERD).   "
194697|NCT00393666|"     Our study examines which different brain regions are involved in child absence seizures and     how they are related to attention and cognition.   "
194698|NCT00393679|"     The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations     (ACT) [amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ),     artemether-lumefantrine (AL) and chlorproguanil/dapsone plus artesunate] for single and     repeat treatments of uncomplicated malaria in children. Safety will be determined by     registering adverse events and grading, laboratory, and vital signs evaluations. Their     incidence will be compared between the different study arms.      TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of     the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap     plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A     formal amendment has been submitted to all the concerned ECs and competent authorities. The     leading EC approved the amendment on 2nd June 2008.      TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and     because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment     in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been     submitted to all the concerned ECs and competent authorities.   "
194699|NCT00393692|"     The purpose of this study is to define phenotypic variations in atrophic Age-Related Macular     Degeneration (AMD) and to identify predictive factors for disease progression based on fundus     autofluorescence imaging.   "
194700|NCT00393705|"     Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic     control while treated with combination of premixed insulin analogue formulations twice daily     and metformin will be randomly assigned to follow one of two insulin treatment strategies     used in combination with metformin administration. The aim of the trial is to try to achieve     optimal metabolic control and explore full therapeutic potential of the strategies, patients     in both arms will follow progressive insulin dose titration algorithms for 16 weeks.   "
194701|NCT00393718|"     This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic     control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after     24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24     weeks followed by a 28 week extension period, in total 52 weeks.   "
194702|NCT00393731|"     The goal of this study is to compare the vaginal delivery rates in women undergoing induction     of labor with an unripe cervix between oxytocin induction alone and preinduction cervical     ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the     time intervals to delivery between the two methods.   "
194703|NCT00393744|"     The primary objective of this study is to demonstrate the non-inferiority, at the assessment     visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI)     administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of     tonsillitis caused by GAS, in subjects aged between 6 and 25 in the per protocol (PP) group.   "
194704|NCT00393757|"     The purpose of this study is to see why malaria epidemics occur in highland areas in Kenya. A     better understanding of factors contributing to malaria may be necessary for malaria vaccine     planning. These factors include interactions between age, where malaria is passed from     mosquitoes to people, immune system (how the body fights infection) responses and other     factors that contribute to malaria in epidemic-prone areas. About 6400 people from the     villages of Kapsisiywa and Kipsamoite will participate. Study procedures will include in home     surveys, which will involve a census and an interview by researchers. Blood samples and     smears will be collected from some volunteers in both communities to understand how the body     protects itself from malaria and to check for malaria parasites. Twice each month, random     houses will be selected from 3 places in the village to measure the number of mosquitoes in     the home. Participants may be involved in the study for up to 4 years.   "
195098|NCT00403169|"     RATIONALE: Lenalidomide may stop the growth of kidney cancer by blocking blood flow to the     tumor.      PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients     with advanced or unresectable kidney cancer.   "
194705|NCT00393770|"     Decreased insulin sensitivity (e.g. insulin resistance) is a hallmark and a major pathogenic     factor of type 2 diabetes. It is the key factor of the metabolic syndrome - a cluster of     arterial hypertension, obesity, impaired glucose tolerance, dyslipidemia, coagulation     abnormalities,albuminuria and increased cardiovascular risk - that may precede or accompany     type 2 diabetes.      Insulin function and the abnormalities associated with insulin resistance, may have a major     role in preventing type 2 diabetes and, in the long-term, diabetes micro- and macrovascular     complications. Carnitine is involved in lipids and carbohydrates metabolism and     acetyl-L-carnitine(ALC), an intramitochondrial carrier of acylic group, may modulate cell     fuel substrate utilization. Studies found that carnitine may improve insulin sensitivity and     glucose disposal in healthy subjects and in patients with type 2 diabetes. A recent study     also found that a primed constant infusion of acetyl-L-carnitine (ALC) may increase glucose     utilization in type 2 diabetic patients, possibly restoring the glycogen synthase activity.      Thus, we designed the Acetylcarnitine in insulin resistance study, a pilot,     sequential,longitudinal study aimed to assess whether acetyl-carnitine may improve insulin     function and lipid profile in patients at increased risk of type 2 diabetes.   "
194706|NCT00393783|"     The purpose of this study is to evaluate whether the injection of HER2/neu DNA is safe and     stimulates an immune response.      The immune system consists of different kinds of cells and substances which help fight     against infections and inflammation in the body. These antibodies and T-cells are part of the     immune system that may also help to fight against tumor cells. One way to make antibodies and     stimulate T-cells is to inject the patient with a preparation which contains material that     may stimulate the immune system. This process is called an immunization. We are trying to     immunize the patient against HER2/neu. In order to participate in this trial, the tumor must     have a large amount of HER2/neu on its surface. The injection that the patient will receive     in this trial is a piece of DNA made in bacteria which contains the gene for rat HER2. DNA is     material which contains the information needed to produce many substances in the body. The     HER2 gene encodes for a protein known as HER2.   "
194707|NCT00393796|"     This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248     (SUTENT), for maintenance therapy in advanced urothelial cancer.   "
194708|NCT00393809|"     This study is designed to assess the safety and preliminary efficacy of five different doses     of DTA-H19 given as six intravesical infusions into the bladder of patients with superficial     bladder cancer who have failed intravesical therapy with Bacille Calmette-Guérin     (BCG).DTA-H19 is a DNA plasmid that contains H19 gene regulatory sequences that drive the     expression of an intracellular toxin [diphtheria toxin A (DTA) chain]only in cancer cells and     not in normal cells. In line with the standard procedure for DNA plasmid pharmaceutical     products, another chemical component will be added to the solution, called PEI     (polyethlenimine) in a liquid solution, which improves the ability of the DNA plasmid to     enter the cells.   "
194709|NCT00393822|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of palifermin     (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of oral     mucositis in subjects with stage 2B and 3 locally advanced, colon cancer receiving     chemotherapy as an adjuvant treatment for their disease.   "
194710|NCT00393835|"     To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or     Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the     SR formulation.   "
194711|NCT00393848|"     The purpose of this study is to determine the effects of two postoperative interventions     designed to preserve muscle protein after major hip or knee surgery.   "
194712|NCT00393861|"     The purpose of this study is to evaluate the effectiveness of oxaliplatin and bevacizumab in     patients with refractory or relapsed germ cell tumors.   "
194713|NCT00393874|"     The purpose of this research study is to evaluate and compare the effects of experimental     treatments aimed at improving insomnia and nightmares in men and women military veterans     between the ages of 18 and 60 years old, and who have a condition called Posttraumatic Stress     Disorder. Insomnia refers to difficulty falling or staying asleep, although enough time is     allowed for sleeping. Insomnia is also associated with daytime consequences, such as lack of     energy, irritability, and difficulty concentrating. Nightmares are bad dreams that may or may     not awaken the sleeper, and that cause discomfort during the daytime.      Chronic Posttraumatic Stress Disorder (PTSD) refers to symptoms that occur after someone     experienced or witnessed a life-threatening event, and that persist for three months or more     after the event. Symptoms include flashbacks, nightmares, feelings of detachment from others,     sleep disturbances, irritability, anxiety, and efforts to avoid people and places associated     with the life-threatening event. These symptoms occur after a life-threatening event.     Symptoms that persist for more than one month indicate the presence of PTSD. In the present     study, we will study people with chronic PTSD, which refers to PTSD symptoms that persist for     more than 3 months.      Efficacy of a treatment is defined as the capacity to produce the desired effects. In this     study, we will evaluate and compare the capacity of two active experimental treatments to     reduce insomnia and nightmares associated with PTSD, and one inactive intervention, called a     placebo, for people who continue to have sleep difficulties despite receiving treatment with     an antidepressant medication called a selective serotonin reuptake inhibitor (SSRI, like     Prozac, Paxil, Zoloft, Celexa). The two active experimental treatments are a medication,     prazosin, and a brief behavioral intervention, which involves exercises and techniques to     reduce nightmares and improve sleep quality. Prazosin is an approved medication by the Food     and Drug Administration (FDA) against high blood pressure, but is not FDA-approved for     posttraumatic insomnia and nightmares.   "
194714|NCT00393887|"     Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein     (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be     blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome     is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.   "
194715|NCT00393900|"     This study will determine if the investigators can use certain tests (eustachian tube     function tests and gas exchange tests) to predict whether or not a child who had tubes     surgically placed in their eardrum because of middle-ear disease will redevelop the disease     again after the tubes quit working.   "
194716|NCT00393913|"     Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops     breathing, or experiences shallow breathing for short periods of time during sleep. Daytime     sleepiness is a common symptom of OSA and may affect an individual's level of alertness     throughout the day. The primary purpose of this study is to evaluate the relationship between     the severity of sleep-disordered breathing and levels of daytime alertness at baseline     (untreated state) in a group of subjects with and without sleep apnea. In addition the change     in daytime sleepiness in subjects with sleep apnea being treated with a continuous positive     airway pressure (CPAP) machine, a common treatment for OSA will also be assessed.   "
195127|NCT00403559|"     This is an exploratory study to determine effectiveness of Elidel for the treatment of     seborrheic dermatitis   "
194723|NCT00394004|"     This study will use focus groups and in-depth individual interviews to explore factors that     influence the decision of Hispanics and African-Americans with HIV/AIDS to participate in a     research study.      HIV-positive Hispanic and African-American patients 18 years of age and older who are     enrolled in an NIH HIV/AIDS protocol may be eligible for Part 1, Part 2, or both parts of     this study, as follows:      Part 1 - Focus group      Focus group participants of from six to ten people are interviewed together during a     one-time, 2-hour tape-recorded session to explore how they arrived at their decision to     enroll in a research study. The group discussion is led by a moderator and a facilitator.     Before the session begins, participants complete questionnaires that include information     about their age, race, ethnicity, education and social support. Hispanic participants also     complete a questionnaire about language preference. At the end of the focus group,     participants are offered to be interviewed individually, as described below.      Part 2 - In-depth interview      An investigator conducts a one-on-one in-depth interview with the participant while a second     person observes and tape records the interview. The interview may take from 1 1/2 to 2 hours     to complete. Participants who were not in a focus group are asked to complete questionnaires     as described in Part 1 above.   "
194724|NCT00394017|"     To evaluate General Practitioners use and reuptake of an e-learning programme in diagnostic     evaluation of dementia after an intervention consisting of three mailed reminder letters.      There is no direct patient involvement in this study.   "
194725|NCT00394030|"     This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes     Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the     bloodstream after a single dose given at different injection sites, and the impact this     medication has on various substances in the blood. Assessments include ECGs, vital signs,     repeat blood sampling and monitoring of any side effects.   "
194726|NCT00394043|"     This study investigated whether an eight-week regimen of osteopathic manipulative treatment     would have immediate and lasting positive effects on the symptoms, functional limitation and     physiologic impairment associated with Carpal Tunnel Syndrome.   "
194727|NCT00394056|"     Tinnitus associated to hearing loss is a high prevalent audiologic disorder with important     unmet needs as far as therapy is concerned. The present study is exploring the possible     beneficial effects on tinnitus loudness or annoyance of a combination drug treatment aimed to     increase the local inhibitory activity of neural circuitries involved in sound perception and     generation. Modest effects have been reported after 8-12 weeks treatment with     antidepressants, including high dose paroxetine (up to 50 mg/day). Biologic data suggests     that the combination of increase of extracellular serotonin using an SSRI and of blockade of     NK1 receptors using a novel NK1 antagonist may lead to a reduced tinnitus and, possibly,     improved hearing acuity. To this aim, two 14 day treatment conditions, i.e., SSRI paroxetine     (20 mg/day) plus the NK1 antagonist vestipitant (25mg /day) or vestipitant alone (25 mg     /day), will be compared to placebo in patients suffering from tinnitus previously selected     for their capacity to reliably score the transient attenuation of tinnitus loudness produced     by lidocaine infusion. Effects on principal endpoints will be collected within 4 hrs from     last administration, when the plasma levels of vestipitant are calculated to be in the range     associated to pharmacodynamic effects on VAS anxiety and qEEG (>30 ng/ml). PK, safety and     tolerability of the paroxetine-vestipitant combination was addressed with preclinical and     Phase I studies, showing no relevant issue. The cross-over study will require approximately     24 patients. Audiometry and computer-based Automated Psychoacoustics will be performed as     instrumental endpoints to support subjective scores. A diary will be used at home to score     tinnitus severity at home during the study.   "
194728|NCT00394069|"     The purpose of this study is to look at the preliminary safety profile of an investigational     drug in children 3 to 6 months of age with bronchiolitis.   "
194729|NCT00394082|"     The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in     combination with bevacizumab.      The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab     for patients with previously untreated advanced/metastatic breast cancer.   "
194730|NCT00394095|"     The primary objective of this study is to examine the efficacy of topiramate in combination     with olanzapine for the prevention of weight gain in youth with bipolar disorder. The     secondary objective is to examine the tolerability of topiramate in combination with     olanzapine for the prevention of weight gain in youth with bipolar disorder.   "
194731|NCT00394108|"     The study aims to evaluate neuropsychological disorders in CABG patients. Measurements are     performed 1 day before, 6 days, 6 months and 3-5 years after the surgery. The relation with     cerebrovascular reactivity and embolic load (measured by transcranial Doppler     Ultrasonography) is evaluated. Two surgery techniques (on- and off-pump CABG) are compared.   "
194732|NCT00394121|"     The purpose of this study is to evaluate the long-term safety of the fixed combination asthma     drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult     and adolescent patients with mild to moderate-severe asthma.   "
194773|NCT00397488|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for their growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with     progressive metastatic transitional cell cancer of the urothelium.   "
194760|NCT00394407|"     High blood glucose levels in hospitalized patients with diabetes are associated with     increased risk of medical complications. Improved glucose control with insulin injections may     improve clinical outcome and prevent some of the hospital complications. It is not known;     however, what is the best insulin regimen in hospitalized patients. The use of repeated     injections of regular insulin (known as sliding scale regimen) is one of the most commonly     used insulin regimen for glucose control in hospitalized patients with diabetes. Recently,     the combination of basal and rapid acting insulins has been shown to improve glucose control     with lower rate of hypoglycemia (low blood sugar).   "
194761|NCT00394420|"     The purpose of this preliminary study was to evaluate the intervention completion rate among     cigarette smokers enrolled through the Emergency Department (ED) in a tobacco quitline (QL)     and to assess the feasibility of a randomized controlled trial assessing the efficacy of this     intervention.   "
194859|NCT00398645|"     This study is designed to determine if the investigational drug is effective and safe in     individuals with asthma.   "
194733|NCT00394134|"     In this study, the researchers will conduct interviews with melanoma patients to describe the     sun exposure and sun protection practices of patients and their children. The researchers     will use the findings of this interview study to develop a salient intervention targeted to     the needs of melanoma patients and their children. The researchers will evaluate the     intervention in a randomized, controlled trial.      The specific aims of this study are:        -  To interview 210 melanoma patients with children 12 years of age or younger to describe          patients' socio-cognitive and psychological factors, describe patients' and children's          sun exposure and sun protection practices, and identify determinants of patients' and          children's sun exposure and protective practices.        -  To develop a targeted behavioral intervention that is designed to increase patients'          protective practices to reduce their children's sun exposure, increase patients'          self-protective practices, decrease the sun exposure levels of patients and their          children, and positively influence socio-cognitive and psychological determinants of          child-centered and self-protective practices.        -  To conduct a randomized, controlled trial in a sample of 360 melanoma patients with          children 12 years of age or younger to evaluate the targeted behavioral intervention          consisting of print and video materials. The intervention will be assessed for its          effects on: 1) child sun exposure and sun protection; 2) patients' protective practices          to reduce their children's sun exposure; 3) patients' sun exposure and self-protective          practices; and 4) patients' socio-cognitive and psychological factors that facilitate          behavior change.   "
194734|NCT00394147|"     The purpose of this study is to look at how well the combination of two chemotherapy drugs,     pemetrexed (Alimta) and gemcitabine (Gemzar) work to treat your cancer.   "
194735|NCT00394160|"     The purpose of this study is to look at the preliminary safety profile of an investigational     drug in children 1 to < 3 months of age with bronchiolitis.   "
194736|NCT00388414|"     Duloxetine has recently been shown to be effective in reducing the pain in chronic pain     patients. Duloxetine is known to exert a central mechanism, however the precise human brain     structures responsible for mediating its pain-relieving properties are not known. We will use     functional magnetic resonance imaging (FMRI) to investigate the neural and functional     correlates of pain.   "
194737|NCT00388427|"     This is an open-label, safety study of cetuximab and differing dose levels of dasatinib in     adult patients with advanced solid malignancies. Cetuximab will be administered as an     intravenous infusion weekly. Dasatinib will be taken orally, once a day, on a continuous     schedule at differing dose levels. The primary objective of this study is to determine the     toxicities and the maximum tolerated doses of dasatinib when combined with cetuximab for the     treatment of advanced solid tumors.   "
194738|NCT00388440|"     To evaluate the safety and immunogenicity of GSK Biologicals' live attenuated MMR vaccine     (Priorix) in a local population in Singapore. The vaccine was administered as a single dose     to healthy children (12-18 months of age) and blood samples were collected at two time points     (before vaccination and after vaccination).   "
194739|NCT00388453|"     The purpose of this study is to establish the clinical application of a new device that     records pH changes in the hypopharynx. The investigators also aim to compare the consistency     of distal esophageal pH with hypopharyngeal pH using both the short and the long     catheters in patients.   "
194740|NCT00388466|"     The purpose of this study is to evaluate the effects of whole body vibration (WBV) on muscle     function in adult CF-patients.   "
194741|NCT00388479|"     Patients undergoing major abdominal surgery are at highest risk for developing postoperative     ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal     distention and bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage     or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will     test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of     surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery     (bowel resection or abdominal hysterectomy).   "
194742|NCT00388492|"     The goal of this study is to evaluate the proportion of subjects both antiretroviral     experienced and virologically suppressed on lopinavir/ritonavir (LPV/r)400/100mg twice daily     who maintain viral suppression after switching to lopinavir/ritonavir (LPV/r)800/200mg once     daily.      The hypothesis for this study is that the majority of subjects will remain virologically     suppressed with once daily dosing versus twice daily dosing and therefore quality of life     will be improved with the once daily dosing of lopinavir/ritonavir (LPV/r)800/200mg.   "
194743|NCT00394173|"     The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for     relieving symptoms of IBS-D in female patients.   "
194744|NCT00394186|"     This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve     IBS pain or discomfort and associated symptoms in IBS patients.   "
194745|NCT00394199|"     To compare the efficacy and safety of the fixed combination asthma drug Flutiform HFA MDI     with its two components administered alone, fluticasone propionate and formoterol fumarate,     in adult and adolescent patients with mild to moderate asthma.   "
194746|NCT00394212|"     It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery     will not meet their weight loss goal, or may even regain some of the weight they initially     lost. One possible explanation is that the opening between the stomach pouch and the     intestine becomes stretched. If this opening becomes too wide, food may be able to pass from     the stomach to the intestine too quickly - causing patients to feel less full after eating.      For some patients, doctors may recommend additional invasive surgery to tighten the opening     between the stomach pouch and the small intestine. Although this may help patients resume     their weight loss, the risk of complications during a second surgical procedure is     significantly higher than the risk during the original gastric bypass.      The purpose of this study is to evaluate an incisionless procedure for patients who have     either had inadequate weight loss or have regained weight following gastric bypass. The     procedure is designed to tighten the opening between the stomach pouch and the small     intestine, which may slow down the passage of food to help patients feel full longer after     eating.   "
194747|NCT00394225|"     We assessed the effect of altering inspired gas on the 6MWT distance in COPD. We hypothesized     that HeO2 would improve walking distance and reduce shortness of breath compared to both RA     and O2, and potentially improve quality of life for COPD patients.   "
194748|NCT00394238|"     Rheumatoid arthritis is a chronic inflammatory systemic disease. It has a worldwide     distribution and can affect all age group. The peak incidence is between fourth and sixth     decade. It is more prevalent in women, and it’s prevalence in the general population in North     America is between 0.2-1.5%. The etiology of RA is unknown, although clusters of the disease     in families and high concordance in mono-zydotic twins support genetic predisposition. The     prevalence of fatty liver disease in patients with rheumatoid arthritis is currently unknown.     We wish to study the link between the two conditions by performing a son graphic imaging of     the liver in a cohort of RA patients. If indeed a high prevalence of NAFLD will be found in     the RA patients, further support will be landed for the link between inflammation and fatty     liver disease. These findings may also have implications regarding the management and follow     up of RA patients.      The validity of sonographic imaging for detection of fatty liver diseases is currently     accepted: On ultrasonographic, fatty infiltration of the liver produces a diffuse increase in     echogenicity as compared with that of the kidneys. Ultrasonography has a sensitivity of 89%     and a specificity of 93% in detecting steatosis and sensitivity and specificity of 77% and     89% respectively in detecting increase fibrosis.      In view of all the above data, we expected to find higher prevalence of fatty liver in the     patients with higher inflammation markers compare with patients with lower markers.   "
194749|NCT00394251|"     The primary objective of this study was to compare the safety of dose-dense ABI-007     (Abraxane) 260 mg/m^2 or Taxol 175 mg/m^2 given every 2 weeks following dose-dense Adriamycin     plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks     throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.   "
194750|NCT00394264|"     Musculoskeletal injuries including low back pain (LBP) are a major problem in military     personnel. These injuries can result from training exercises, job duties, or recreational     activities. However incurred, many of these injuries can result in limited duty in work or     training, and can decrease military readiness.      The National Osteopathic Research Center (ORC) will examine the effectiveness of a specific     set of Osteopathic Manipulative Treatment interventions referred to as Manual/Manipulative     Therapy (M/MT) to reduce pain and improve functioning in young active duty military     personnel.      The broad overall goal of this proposed research project is to determine the feasibility of     conducting a larger clinical trial of Manual/Manipulative Therapy (M/MT) in restoring full     performance in military personnel in the operational environment. A second goal is to     estimate the treatment effect size of M/MT in this population.      The following two hypotheses will guide the data study:        -  Hypothesis 1: Subjects receiving manual/manipulative therapy for low back pain will          report less pain at two and four weeks than subjects in the control group.        -  Hypothesis 2: Subjects receiving manual/manipulative therapy for low back pain will          achieve greater functioning at two and four weeks than subjects in the control group.   "
194751|NCT00394277|"     This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance     dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety     of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with     chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight     ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS     180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg     sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed     by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc     weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po     daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free     follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size     is 500+ individuals.   "
194752|NCT00394290|"     The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive     Pressure for SAOS in Down Syndrome patients.   "
194753|NCT00394303|"     Blood glucose levels increase in response to stress, infection or other conditions faced by     patients in the hospital. This occurs commonly among patients with known diabetes, but also     among non-diabetic hospitalized patients. Tight glucose control, the maintenance of blood     glucose levels within normal limits (80-120 mg/dl), has been shown to improve patient     outcomes in the hospital in several settings, mainly among critically ill patients     hospitalized in intensive care units.      We plan to assess the importance of tight glucose control during open-heart surgery. The     prevalence of hyperglycemia (elevated blood glucose) during this operation is high.     Hyperglycemia may be associated with increased vulnerability to surgical site infections,     neurological damage, cardiac and renal injury. Conversely, tight glucose control may be     associated with hypoglycemia (pathologically low glucose levels) that may results in     neurological injury. We hypothesize that tight glucose control will improve patient outcomes     following surgery.   "
194754|NCT00394316|"     X-linked Chronic Granulomatous Disease (CGD) is an inherited disorder caused by an abnormal     gene that fails to make the protein known as gp91 phox. This protein is part of a group of     proteins that work to create hydrogen peroxide in neutrophils. Neutrophils are a type of     white blood cell that helps fight infections. As a result, patients who do not make this gp91     phox frequently develop life-threatening infections. In addition, these neutrophils often act     abnormally, resulting in the creation of a granuloma, which is an abnormal collection of     cells. These granulomas can then become large enough to block organs, such as the bladder     and/or intestines, causing significant problems. Patients are usually treated with     antibiotics (often needed for extended periods of time) for the infections caused by CGD, and     with corticosteroids for the granulomas. However, these drugs do not cure CGD itself, and can     have significant side effects. Thus patients with CGD do not have a normal life expectancy.      The only available cure to date for CGD is Bone Marrow Transplantation (BMT), where the     blood-making cells from a specially matched brother or sister donor (allogeneic) or a     similarly matched unrelated donor are given to the patient after the patient has undergone     some kind of chemotherapy or radiation in preparation for receiving the cells. If the cells     from the donor engraft (or survive in the marrow), the patient can be cured; however, there     is a risk that the cells may not engraft or that they may later get rejected from the body.     Also, the cells from the donor can react against the patient, causing a serious disorder     called Graft Versus Host Disease (GVHD). Although there are a number of methods used to try     to reduce and/or prevent graft rejection and/or GVHD, these complications can still occur     even with the newer methods now being developed. The risks of such complications are lower     when a brother or sister is used as the donor; however, not all patients (even those with     siblings) will have an ideally matched donor. Hence, transplantation, especially when using     an unrelated donor, is not always a perfect cure.      Because the gene responsible for making the gp91 phox is known, it is possible to use gene     therapy to try to cure this disease. In gene therapy, some of the blood-making cells are     taken from the patient using a technique called apheresis. The normal gene is placed into the     cells using special viruses called retroviruses. The cells are then able to produce the     normal protein. In this trial, the patient will receive a small dose of chemotherapy called     busulfan, lower than what is traditionally used in allogeneic BMT, and the newly corrected     cells will then be put back into the patient.      Even with the best standard of care, a number of patients with CGD will still die from     infection. For those patients who have an unresponsive or progressive infection and do not     have a possible sibling donor, their only hope is either a Matched Unrelated Donor (MUD)     transplant, which has a high risk of causing death itself, or gene therapy. Hence, we would     propose using gene therapy in these patients as this has less risk of causing death, but can     still possibly offer a cure. Even if the corrected cells do not remain life long to rid the     patients entirely of their disease, as long as they persist for even a few months, they would     be able to at least clear the current infection for which the patients are being considered     for enrollment in this protocol. Further, they would still be eligible to undergo a matched     unrelated donor transplant in the event that gene therapy does not confer any benefit.   "
194755|NCT00394329|"     Asthma is a common, serious illness among children in the United States. It can be     effectively controlled through the use of preventative medications and rescue medications,     which are used to control symptoms. This study will evaluate the impact and severity of     asthma exacerbations that occur in children with mild persistent asthma who are receiving     various combinations of medications for daily and rescue use.   "
194756|NCT00394355|"     This is a randomized, multi-center, parallel-group, active-controlled, double-blind study     evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral     density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the     averaged baseline value (the average of the two scan results prior to treatment) to the     endpoint of treatment time point (the average of the last two valid post-baseline scan     results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus     montelukast (ML) 10 mg daily in the evening.   "
194757|NCT00394368|"     The aim of this study was to compare the efficacy and tolerability of the fixed combination     beclomethasone/formoterol pMDI with that of fluticasone/salmeterol pMDI in patients with     moderate to severe asthma   "
194758|NCT00394381|"     A phase I/II study to explore the feasibility and efficacy of autologous CIK cells in     patients with acute myeloid leukemia (AML)/ high grade myelodysplastic syndrome (MDS)        1. Group 1: As adjuvant therapy in minimal residual disease state after autologous PBSCT.        2. Group 2: As an adoptive immunotherapy in untreated disease state when conventional          therapy with curative intent is not applicable   "
194762|NCT00394433|"     The purpose of this research study is to determine if the combination of docetaxel,     cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric     cancer and how the cancer responds to this combination. Bevacizumab is a new drug that is     believed to stop the formation of new blood vessels that carry nutrients to tumors.     Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin     and irinotecan are traditional chemotherapy agents that have been tested together in another     clinical trial for esophageal and gastric cancer. It is hoped that adding bevacizumab to this     regimen will make the treatment more effective.   "
194763|NCT00394446|"     Phase 1, Multiple Dose Study of MPC-6827 in Subjects with Refractory Solid Tumors.   "
194764|NCT00394459|"     Primary Objective: The primary objective is to demonstrate that the safety of Perifix New is     non-inferior to using Perifix Standard when applied for thoracic epidural anaesthesia.      Primary Endpoint: Incidence of spontaneous paraesthesia during catheter insertion      Secondary Objectives: The secondary objectives are to determine the safety and performance of     the investigational product: frequency of inadvertent vascular cannulation, difficulties     involved in insertion and removal of the catheter, other safety features and data for the     evaluation of handling characteristics.      Title: Randomised, prospective, single-blind, controlled, study on the safety of two epidural     catheters in patients undergoing surgery under thoracic epidural anaesthesia      Investigational Product: Perifix Epidural Anaesthesia Catheter      Test Product: Perifix New      Reference Product: Perifix Standard      Number of Sites and Countries: 1 site in The Netherlands      Indication: Thoracic epidural anaesthesia      Study Design: Randomised, prospective, single-blind, controlled study in 1 study center,     phase IV      Perifix New and Perifix Standard meet all the appropriate provisions of the relevant     legislation implementing European Directives (both have CE-marking).      Study Duration: 2 year duration      Study Start: March-April 2005      Sample Size: n = 2*70 patients   "
194765|NCT00394472|"     The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a     Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients     with an incomplete response to PPI treatment.   "
194766|NCT00394485|"     Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs.     tiotropium alone among patients with moderate chronic obstructive pulmonary disease   "
194767|NCT00394498|"     Eighty-six patients with heart attacks will be identified at our hospital. Post heart attack     we will assess heart function, blood flow to the heart, and heart cell function. We will     assess these parameters using nuclear cardiology scans that are used in everyday cardiology     practice. The patients will then be divided into 2 groups. One group will receive a     medication called G-CSF and the other group will receive a placebo. We will give this drug     (1-2ml) for 4 days beneath the skin. We will take the patients blood during this time and     measure how the drug affected their blood. The patients will all have the nuclear cardiology     tests again in 6 weeks and 6 months to see how their heart is functioning. As well, they will     have a six month angiogram. All the patients will otherwise receive optimal care from their     Cardiologist. They will be seen at 6, 12, 24, and 52 weeks to assess them clinically.      This study will test the effects of G-CSF on the heart function of patients who have had a     heart attack. It is a medication that that has been shown in an animal model to improve heart     function after a heart attack. It is a medication that has been used for many years to treat     patients with cancers and to increase the number of cells donated by healthy bone marrow     donors. It has no serious side effects. It works by increasing the number of a person’s own     stem cells in the blood. Stem cells are special cells that are present in our bodies that     have the ability to form new cells. It had been thought that the heart could not make new     cells after it has been damaged. Other investigators have shown that this might not be the     case. It is now thought that after an injury, stem cells from the bone marrow can transform     into cells of the injured tissue. Therefore, we are trying to increase the number of stem     cells in the circulation with G-CSF so as to increase repair in the heart after it has been     damaged. This strategy has never been tried in human beings and if successful could greatly     reduce death and suffering from heart disease.   "
194768|NCT00394511|"     Randomized phase III trial to compare treatment with or without adjuvant radiation therapy in     men with stage III prostate cancer who have had radical prostatectomy and lymphadenectomy     recently. Radiation therapy uses high-energy x-rays to damage tumor cells and may be an     effective treatment for prostate cancer.   "
194769|NCT00397436|"     The main focus of this pilot study is to construct a fairly complete protein profile of the     epidermis. This will allow us to study how the epidermis responds to external stressors such     as ultra-violet. We hypothesize that by using the cutting edge technology, proteomics, we     will be able to construct a fairly complete profile of different epidermal cells     (keratinocytes, epidermal nerve fibers (ENFs), melanocytes, Langerhans cell,...etc) of normal     and ultraviolet (UV) irradiated skin.   "
194770|NCT00397449|"     This is a randomized, open, dose-selection Phase 1 study. The study aims to evaluate the     safety and immunogenicity of 3 doses (10,30 & 100 micrograms) of the GMZ2 hybrid (GLURP and     MSP3) blood stage vaccine in healthy non-immune European adults. The vaccines will be     administered with aluminum hydroxide as adjuvant. The safety and the tolerability of the     vaccine will be assessed on the rate of solicited and unsolicited events/reactions related to     the vaccine. The safety profile will include local and systemic reactions/events as well as     the biological safety, based on a clinically significant change of the baseline value of the     main biological criteria. The immunogenicity of the different formulation of the vaccine will     be assessed on the level and the quality of circulating antibodies as well as the stimulation     of the T-cell immune response.   "
194774|NCT00397501|"     RATIONALE: Osmotic blood-brain barrier disruption uses certain drugs, such as mannitol, to     open the blood vessels around the brain and allow tumor-killing substances to be carried     directly to the brain. Drugs used in chemotherapy, such as methotrexate and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Trastuzumab     may also help methotrexate and carboplatin work better by making tumor cells more sensitive     to the drugs. Giving osmotic blood-brain barrier disruption together with methotrexate,     carboplatin, and trastuzumab may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of carboplatin when     given together with methotrexate and trastuzumab after mannitol in treating women with breast     cancer that has spread to the brain.   "
194801|NCT00397865|"     The purpose of the research is to find out if an educational booklet is helpful to families     with overweight children. The educational booklet contains information for parents about     nutritious eating, physical activity, and strategies for healthy living.   "
194890|NCT00399061|"     The purpose of this study is to evaluate the efficacy of Optive versus Systane used     concomitantly with topical cyclosporine for the treatment of dry eye.   "
194775|NCT00397514|"     Malformations of the heart (congenital heart disease) are the most common congenital birth     defects, occurring in about 1% of children. Each year, between 150-200 children will undergo     open heart surgery at British Columbia Children's Hospital (BCCH) to repair the defect(s) in     their heart. The abnormal structure of the heart or the open heart surgery may cause damage     to the electrical system of the heart which can disturb the rhythm of the heart     (arrhythmias), prolong recovery or be life-threatening. For this reason, temporary pacing     wires are placed in the heart following surgery to ensure the heart rhythm is as normal as     possible during the post-operative period (pacing). In recent years, scientists have     recognized that pacing the heart from one area is not necessarily the same as pacing it from     a different area. In fact, in some individuals with arrhythmias and poor heart function,     pacing the heart from different areas can improve the pumping of the heart, resulting in     better heart function. This form of treatment is called Cardiac Resynchronization Therapy     (CRT) because it endeavours to optimize the pumping of the heart by changing the electrical     activation of the heart. CRT has been used to a very limited extent in children. A few     pediatric cardiologists have used CRT to help children who are in heart failure. We would     like to determine whether pacing the heart from different areas after open heart surgery     improves the child's heart function and aids his or her recovery.   "
194776|NCT00397527|"     The purpose of this study is to demonstrate the safety of the gynecological formulation in     normal and usual usage condition of Dermacyd Wipes   "
194777|NCT00397540|"     The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA     level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs)     related with HBV.   "
194778|NCT00397553|"     To provide local data on efficacy and safety of insulin glulisine in patients with Type 1     Diabetes Mellitus receiving insulin glargine as basic insulin therapy   "
194779|NCT00397566|"     The purpose of this clinical research study is to assess the safety, pharmacokinetics and     pharmacodynamics of BMS-707035 in subjects infected with HIV-1   "
194780|NCT00397579|"     RATIONALE: Combinations of biological substances in DT388IL3 fusion protein may be able to     carry cancer killing substances directly to the cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of DT388IL3 fusion     protein and to see how well it works in treating patients with acute myeloid leukemia or     myelodysplastic syndromes.   "
194781|NCT00397592|"     To assess the effect of short-term low-dose growth hormone therapy on the mobilization of     endothelial progenitor cells from the bone marrow within a group of healthy adults.   "
194782|NCT00397605|"     Some people with bipolar disorder who use cannabis (marijuana) claim that it eases the     symptoms of depression and mania. There are many chemicals (called cannabinoids) found in     cannabis but two particular ones appear to have medicinal (therapeutic) effects. These two     compounds are: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). These cannabinoids     appear to have mood, anxiety, and sedative effects as well as have antipsychotic and     anticonvulsant properties. This study will try to find out if these cannabinoids can be of     benefit as an add-on treatment in bipolar disorder and what effects it has on thinking power     and memory.   "
194783|NCT00397631|"     A clinical study to evaluate the safety and efficacy of the initial combination therapy with     sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with     insulin or oral antihyperglycemic therapy.   "
194784|NCT00397644|"     The objective of this study is to evaluate the impact and feasibility of a practice-based     intervention on the discussion and referral of family psychosocial topics at well-child care     visits at a medical home for low-income children.   "
194785|NCT00397657|"     Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of     low-density lipoprotein (LDL-C) to provide greater protection from recurrent coronary heart     disease (CHD) events. Thus, in August 2005, the guidelines for the treatment of lipid     disorders (NCEP ATPIII) were revised to indicate that an LDL-C treatment goal of 70 mg/dL     (revised from 100 mg/dL) was optional for patients with known CHD. In these same guidelines,     low levels of high-density lipoprotein (HDL-C) are also suggested but not specifically     proscribed as a target of therapy. Recently the ARBITER 2 trial has provided the first     evidence of the potential of raising HDL-C with extended release niacin when added to statin     monotherapy. However, whether this approach would be superior to a strategy in which lower     concentrations of LDL-C are targeted is unknown.      The purpose of ARBITER 6 - HALTS is to compare HDL and LDL-focused strategies of lipid     treatments for their effects of atherosclerosis. This study is a prospective, randomized,     open-label, blinded endpoint trial comparing treatment strategies of either HDL-raising     therapies or LDL reduction for dyslipidemia on carotid atherosclerosis. Subjects with known     atherosclerotic coronary or vascular disease or otherwise at high cardiovascular risk through     the presence of a coronary risk equivalent who are currently being treated with a statin will     be eligible. Subjects will be randomly assigned in an allocation-concealed fashion to open     label treatment with either Ezetimibe 10 mg/d for additional LDL-lowering OR Extended-release     niacin (1 gm/d, titrated to max tolerable dose up to 2 gm/d) for HDL improvement.      The effects of these 2 different strategies of intensified lipid management on     atherosclerosis will be assessed by the change in the carotid intima-media thickness, a     validated surrogate endpoint. The data will help guide clinicians on the potential benefits     of these lipid treatment strategies.   "
194786|NCT00397670|"     The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel     used with a contraceptive diaphragm.   "
194787|NCT00397683|"     The purpose of this study is to test MK0822 on disease activity in patients with     osteoarthritis in the knee. Disease modifying activity of MK0822 will be assessed by     measurements of knee cartilage using Magnetic Resonance Imaging (MRI) of the knee.      This is an early phase trial and some specific protocol information is proprietary and not     publicly available at this time. (Full information is available to trial participants).   "
194788|NCT00397696|"     The underlying goal of this study is to assess [123I] 5-IA and SPECT imaging as a tool to     detect nicotinic receptor activity in the brain of PD patients. All study procedures will be     conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging     (MNI) in New Haven, CT. Approximately 10 patients with a diagnosis of PD without cognitive     changes will be recruited to participate in this study. Patients will be eligible to     participate if they have a diagnosis of PD of more than 2 years duration and have no     significant cognitive changes.   "
194802|NCT00397878|"     This phase II trial is studying how well AZD0530 works in treating patients with previously     treated metastatic colon cancer or rectal cancer. AZD0530 may stop the growth of tumor cells     by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell     growth.   "
194803|NCT00397891|"     Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational     AAB-001 Vaccine in Japanese patients with Alzheimer's disease.   "
194789|NCT00397709|"     The objective of the study was to compare the compliance and the side effects of a short     course to treatment of latent tuberculosis infection during 3 months(isoniazid plus     rifampin)group I, with the standard course for 6 months(isoniazid)group II .Prospective,     comparative, randomized and open trial of patients with positive TST and the suitable     criteria for treatment, in accordance with the guidelines of the CDC, excluding HIV     infection. 105 patients were included. In Conclusion, a short course with isoniazid plus     rifampin during 3 months shown better compliance with a lower percentage of abandonment that     the course 6H. Tolerance is similar in the two courses.   "
194790|NCT00397722|"     GW876008 is a drug which may change mans reaction to stress, by decreasing the fear, physical     and behavior symptoms that people with SocAD experience in social situations.   "
194791|NCT00397735|"     The aim of the study is to determine if N-acetylcysteine (a potent free radical scavenger)     prevents the occurrence of adverse neonatal outcomes in preterm deliveries complicated by     infection associated with preterm labor or preterm premature rupture of membranes (PPROM).     The working hypothesis is that in pregnancies complicated by intra-amniotic infection or     inflammation, N-acetylcysteine protects the fetus by preventing the development, or     decreasing the intensity and/or progression of the fetal inflammatory syndrome.   "
194792|NCT00397748|"     This study will explore the brain in men with and without attention deficit hyperactivity     disorder (ADHD). It will use positron emission tomography (PET) and magnetic resonance     imaging (MRI) to study brain function and nerve cell communication involving phospholipids     (fatty molecules that make up the covering of nerve cell fibers in the brain and are involved     in communication between the cells). It will also look at how nerve cell communication is     related to blood flow. In particular, the study will explore communication through the     dopamine system, which is one of the main neurotransmitter systems in the brain involved in     ADHD.      Healthy men and men with ADHD between 18 and 55 years of age may be eligible for this study.      Participants undergo the following procedures:      <TAB>Medical history and psychiatric and medical evaluation, including blood and urine     tests.      <TAB>MRI scan. This test uses a strong magnetic field and radio waves to obtain images of     the brain. The subject lies still on a table that slides into the scanner (a metal cylinder)     during the scanning.      <TAB>PET scanning. The subject lies on the scanner bed with his head held still using a     special facemask. A catheter (plastic tube or needle) is placed in an artery to collect blood     samples and in a vein to inject radioactive isotopes for measuring blood flow and     phospholipid metabolism. Scans are done after an injection of a saline solution and again     after injection of apomorphine, a medication that turns on dopamine receptors in the brain.     The injections are given under the skin of the abdomen, about one and a half hours apart....   "
194793|NCT00397761|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving more than one drug (combination     chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed.      PURPOSE: This phase II/III trial is studying how well giving capecitabine together with     paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing     surgery for stage II or stage III breast cancer.   "
194794|NCT00397774|"     The project consists of two studies where we want to throw light on the importance of     physical activity/exercise to maintain physical function among cancer patients whose disease     is not responsive to curative treatment. Study I is a randomised intervention study where we     want to study the effect of adjusted physical exercise compared to usual care. In study II     our main aim is to validate different subjective and objective methods to measure physical     functioning   "
194795|NCT00397787|"     This phase II trial is studying how well sunitinib works in treating patients with metastatic     pancreatic cancer that progressed after first-line therapy with gemcitabine. Sunitinib may     stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some     of the enzymes needed for cell growth.   "
194796|NCT00397800|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal     antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry     cancer-killing substances to them without harming normal cells. Giving rituximab and     chemotherapy together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of yttrium Y 90     ibritumomab tiuxetan when given together with rituximab, fludarabine, and cyclophosphamide     and to see how well they work in treating patients with relapsed B-cell non-Hodgkin's     lymphoma.   "
194797|NCT00397813|"     This phase II trial studies the side effects and best dose of total-body irradiation when     given together with fludarabine phosphate followed by a donor peripheral stem cell transplant     in treating patients with myelodysplastic syndromes (MDS) or myeloproliferative disorders     (MPD). Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body     irradiation before a donor peripheral blood stem cell transplant helps stop the growth of     cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving cyclosporine and mycophenolate     mofetil after the transplant may stop this from happening.   "
194799|NCT00397839|"     Male osteoporosis is a common and important clinical problem, associated with significant     morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are     osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given     150 mg once-monthly for 12 months versus placebo in men with primary osteoporosis. Less     frequent, once monthly, dosing is expected to improve patient's treatment adherence compared     to a weekly dosing regimen.   "
194800|NCT00397852|"     We create a randomized clinical trial between treatment with and without Kirschner wire     fixation of a stable dislocated distal both-bone forearm fracture.   "
194804|NCT00397904|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth     of tumor cells by blocking some of the enzymes needed for their growth. Drugs used in     chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab     together with cisplatin and irinotecan may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin     and irinotecan works in treating patients with metastatic esophageal cancer, gastroesophageal     junction cancer, or gastric cancer that did not respond to previous irinotecan and cisplatin.   "
194805|NCT00397917|"     The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception     and during the first three months of pregnancy decreases the risk of having a child with     cleft lip and palate compared to 0.4 mg folic acid for women who have an oral cleft or have     had previously child with an oral cleft.   "
194806|NCT00397930|"     RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.      PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in     cancer survivors.   "
194807|NCT00397943|"     This study will assess the safety and immunogenicity of 2 different formulations of     tuberculosis vaccine GSK692342 in healthy adults.   "
194808|NCT00397956|"     To collect clinical response data with the use of ertapenem in community acquired sepsis.   "
194809|NCT00397969|"     RATIONALE: Receiving a reminder letter from their doctor may increase the frequency of     colonoscopy in patients who have had a colorectal polyp removed.      PURPOSE: This randomized clinical trial is studying how well a reminder letter from their     doctor improves the frequency of colonoscopy in patients who have had a colorectal polyp     removed.   "
194810|NCT00397982|"     This phase II trial is studying how well giving temsirolimus together with bevacizumab works     in treating patients with stage III or stage IV malignant melanoma. Temsirolimus may stop the     growth of tumor cells by blocking some of the enzymes needed for their growth. Monoclonal     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Bevacizumab may also stop the growth of malignant     melanoma by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab     may kill more tumor cells.   "
194811|NCT00397995|"     We create a randomized clinical trial between above- and below elbow cast to find out what     kind of treatment is optimal for undislocated both-bone distal forearm fractures.   "
194812|NCT00398008|"     A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance     treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin     and opium addicts in Iran.   "
194813|NCT00398021|"     The purpose of this research is to see if a questionnaire on bowel habits can help identify     children who will have constipation 12 months later.   "
194814|NCT00398034|"     The purpose of this pilot study is to test the effects of testosterone replacement on pain,     fatigue, mood, cognition and libido in hypogonadal men on long-term opioid therapy for     chronic pain.   "
194815|NCT00398047|"     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop     the growth of abnormal cells, either by killing the cells or by stopping them from dividing.     Colony-stimulating factors, such as darbepoetin alfa and G-CSF, may increase the number of     red blood cells and white blood cells found in bone marrow or peripheral blood and may help     the immune system recover from the side effects of chemotherapy. Giving azacitidine together     with darbepoetin alfa and G-CSF may be an effective treatment for myelodysplastic syndromes.      PURPOSE: This clinical trial is studying how well giving azacitidine together with     darbepoetin alfa and G-CSF works in treating patients with myelodysplastic syndromes.   "
194816|NCT00398060|"     Life-style change achieved in controlled experimental condition has been shown to prevent     type 2 diabetes. The purpose of this study is to evaluate to what extent the life-style     change can be achieved in a routine health care setting.   "
194817|NCT00398073|"     RATIONALE: Vaccines made from DNA may help the body build an effective immune response to     kill tumor cells. Giving the vaccine in different ways may make a stronger immune response     and kill more tumor cells.      PURPOSE: This randomized clinical trial is studying two different ways of giving vaccine     therapy to compare how well they work in treating patients with stage IIB, stage IIC, stage     III, or stage IV melanoma.   "
194818|NCT00398086|"     To determine the maximum tolerated dose and dose-limiting toxicity of Gemcitabine plus     Albumin-bound paclitaxel (ABI-007) in patients with advanced metastatic pancreatic cancer.   "
194819|NCT00398099|"     To collect clinical response data with the use of ertapenem in approved indications.   "
194820|NCT00398112|"     This phase II trial is studying how well sunitinib works in treating patients with relapsed     or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Sunitinib may stop     the growth of cancer cells by blocking some of the enzymes needed for cell growth and by     blocking blood flow to the cancer.   "
194821|NCT00398125|"     To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected     adults   "
194822|NCT00398138|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill cancer cells. Biological therapies, such as GM-CSF, may stimulate the immune system     in different ways and stop cancer cells from growing. Giving vaccine therapy together with     GM-CSF may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects of vaccine therapy and GM-CSF in     treating patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung     cancer, or mesothelioma.   "
194823|NCT00398151|"     To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from     peripheral blood after newly initiated montelukast therapy.   "
194824|NCT00398177|"     The purpose of this study is to characterize the molecular and cell biology of the tumor     cells in lymphoma.   "
196027|NCT00411645|"     The purpose of this research study is to investigate whether or not maribavir is safe and     effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who     have had a stem cell transplant.   "
194828|NCT00398229|"     The implantation rate after frozen-thawed embryo transfer cycles depends mostly on the     receptivity of the endometrium and the embryo quality.The effects of human chorionic     gonadotropins (hCG) on the endometrium have been investigated for several years. hCG was     shown to up-regulate gene expression during the differentiation of human endometrial stromal     cells into decidua. The aim of our study was to assess the benefit of hCG supplementation     throughout the secretory phase of artificial frozen-thawed embryo transfer cycles.   "
194829|NCT00398242|"     We create a randomized clinical trial between the treatment with above elbow armcast alone     and the treatment of above elbow in combination with a short arm cast for stable midshaft     both-bone forearm fractures.   "
194830|NCT00398255|"     Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or     fibromyalgia) and internet and email access were randomized to receive an internet-based     arthritis self-management program (treatment group) or to continue with usual care (control     group). Questionnaires measuring health indicators, health behaviors, self efficacy and     health care utilization were administered at baseline, six months and one year after the     course. It was hypothesized that those participating in the course would have better outcomes     than the control group at six months and one year.   "
194831|NCT00398268|"     We create a follow-up study of Kirschner wire fixation of a unstable dislocated distal     both-bone forearm fracture.   "
194832|NCT00398281|"     RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate     cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate     cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more     effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer.      PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy     to see how well they find prostate cancer compared with a placebo and ultrasound-guided     biopsy.   "
194833|NCT00398294|"     To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients     with hypercholesterolemia.   "
194834|NCT00398307|"     This is a Phase I, open-label study evaluating the PK of S-1 components and their metabolites     in patients with advanced solid tumors and varying degrees of renal function. Patients will     be stratified by baseline 24-hour creatinine clearance(CrCL) into 4 cohorts using the normal     clearance formula:      Group A: Control Group B:Mild renal dysfunction Group C:Moderate renal function and Group D:     Severe renal dysfunction. Six patients will be enrolled into each cohort.   "
194835|NCT00398320|"     Given the lack of other viable treatment options for metastatic neuroendocrine tumors,     contrasted with our positive anecdotal experience, and the relative tolerability of the     treatment regimen for colorectal cancer patients, we propose a single-institution phase II     trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients     with metastatic neuroendocrine tumors.   "
194836|NCT00398333|"     The purpose of this study is to determine if a nutritional supplement enriched in omega-3     fatty acids is effective in improving the tolerance to chemotherapy treatment and improves     quality of life.   "
194837|NCT00398359|"     This project will apply the concepts from the Chronic Care Model to the problem of pediatric     obesity and proposes: 1) to assess the effectiveness of teaching primary care providers (in     diverse practice settings) to use specific communication strategies with parents of     overweight and obese children to help them take steps with their child toward healthy     behavior change; 2) to offer core components of an efficacious evidence-based pediatric     obesity treatment within the pediatric primary care setting to determine if participating     children will achieve clinically meaningful weight loss (assessed as weight and BMI     percentile changes at the end of treatment and at a six month follow-up); and 3) to assess     the ability of trained, behavioral psychologists to offer the treatment so that desired child     outcomes are achieved. The primary project outcomes will include: 1) increase in     self-reported physician confidence in use of counseling skills related to pediatric     overweight; and 2) change in child's diet, physical activity, weight and BMI percentile at     the end of treatment and at 6-month follow-up.   "
194838|NCT00398372|"     To characterize the molecular and cell biology of the tumor cells in lymphoma. The mechanism     of monoclonal antibody treatment by rituximab or epratuzumab will also be examined.   "
195128|NCT00403572|"     The purpose of this study is a systematical registration of hemodynamic measurements (cardiac     output, blood pressure and systemic vascular resistance) in women with serious preeclampsia.   "
194839|NCT00398385|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount     of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any     tumor cells that remain after surgery. It is not yet known whether giving chemotherapy before     surgery is more effective than giving it after surgery in treating non-small cell lung     cancer.      PURPOSE: This randomized phase II trial is studying gemcitabine and cisplatin to compare how     well they work when given before or after surgery in treating patients with stage I or stage     II non-small cell lung cancer.   "
194840|NCT00398398|"     The combination of capecitabine and oxaliplatin as 'backbone' regimen, adding a newer     biologic agent, cetuximab, is a reasonable strategy of further chemotherapy development in     advanced gastric cancer, which is the investigators study rationale.   "
194841|NCT00398411|"     This study investigates whether the prophylactic use of moxifloxacin during high-dose     chemotherapy followed by autologous stem cell transplantation reduces the incidence of     clinically significant bacteremia.      Further investigations include time to occurrence of fever, duration of fever, overall     survival and antibiotic sensitivity of blood isolates.   "
194842|NCT00398424|"     This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites     in patients with advanced solid tumors and varying degrees of hepatic function defined by the     NCI classification for hepatic impairment. Patients will be stratified into 4 Cohorts-     Normal, Mild, Moderate or Severe.      Six patients will be enrolled inot each cohort and receive S-1.   "
194843|NCT00398437|"     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help doctors     find CNS metastases and plan treatment.      PURPOSE: This randomized clinical trial is studying how well MRI finds CNS metastases in     women with stage IV breast cancer.   "
194844|NCT00398450|"     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together     with interferon alfa may be an effective treatment for melanoma.      PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when     given together with interferon alfa in treating patients with metastatic melanoma.   "
194845|NCT00398463|"     This study will evaluate whether adding tirofiban, administered at high bolus dose on top of     aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction     after percutaneous coronary intervention in elective patients presenting with aspirin and/or     clopidogrel resistance.   "
194846|NCT00398476|"     The objectives of this study are to evaluate and compare patient preference for FF     (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of     allergic rhinitis following single-dose administration.   "
194847|NCT00398489|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, epirubicin, and cyclophosphamide,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Giving     chemotherapy with or without monoclonal antibody therapy before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed. Giving these     treatments after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving docetaxel, epirubicin, and     cyclophosphamide with or without trastuzumab works in treating women with locally advanced     breast cancer that can be removed by surgery.   "
194848|NCT00398502|"     Primary: To determine the relative bioavailability of MOA-728, an investigational drug,     administered orally in both the capsule and tablet formulations to methadone maintenance     subjects.Secondary: To assess the pharmacodynamic effect of MOA-728 administered both orally     and subcutaneously to methadone maintenance subjects using the oral-cecal transit time.   "
194849|NCT00398515|"     This phase I trial is studying the side effects and best dose of temsirolimus when given     together with lenalidomide in treating patients with previously treated multiple myeloma.     Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer.     Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth     of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus     may also stop the growth of cancer cells by blocking some of the enzymes needed for their     growth. Giving lenalidomide together with temsirolimus may kill more cancer cells.   "
194850|NCT00398528|"     Impaired short term memory, attention and concentration lapses, and slower processing of     information occur in up to 40-65% of patients with Multiple Sclerosis (MS). The quality of     life of individuals with MS is impacted to the degree with which they experience these     symptoms.      There are several medications approved by the United States Food and Drug Administration     (FDA) to treat MS symptoms and to modify (slow) disease course. Traditional approaches to     determining the effectiveness of medications used in treating MS rely on reports of the     number of relapses an individual experiences, as well as standard clinical tests, such as the     Kurtzke Expanded Disability Status Scale (EDSS).      This research study will look at whether the functional magnetic resonance imaging (fMRI)     scan can be used as a tool for measuring changes in the brain associated with treatment in MS     patients. Unlike a typical MRI which provides structural information about the brain, the     fMRI provides information about brain activity during performance of cognitive or motor     tasks.   "
194851|NCT00398541|"     Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in     comparison with Natrilix(TM).   "
194852|NCT00398554|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving combination     chemotherapy may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects and how well combination     chemotherapy works in treating young male patients with Hodgkin's lymphoma.   "
194853|NCT00398567|"     The purpose of this study is to learn whether it is safe and effective to administer HKI-272     (neratinib) in combination with Herceptin in patients with advanced breast cancer.   "
194854|NCT00398580|"     The combination of testosterone and dutasteride is intended for use in hypogonadal men. This     study will evaluate the effect of 28-day repeat dosing of this combination with varying BID     doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well     as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the     effects of each compound on the other, and to look for any safety problems that may result     when the 2 drugs are given together.   "
194855|NCT00398593|"     Ulcerative Colitis is associated with a significantly increased risk of colorectal cancer.     This risk can be reduced through regular medication with 5ASA compounds. Their effectiveness     however is limited by poor adherence to the treatment protocols by many patients.      The hypothesis which underlies this proposal is that if the factors responsible for poor     compliance can be identified, interventions could be developed which would help to overcome     the barriers which exist in individual patients. These interventions would be based on the     reasons for non-adherence, specifically tailored to the needs of the individual. As a result     such interventions will improve patients' adherence with prescribed 5ASA and therefore reduce     the relapses of the disease and a cancer risk.   "
194856|NCT00398606|"     The purpose of this study is to see how well alendronate and calcium as compared to calcium     alone increase bone density in postmenopausal women with osteoporosis   "
194857|NCT00398619|"     The purpose of this study is to determine whether the investigational drug INCB013739 has an     effect on systemic and adipose tissue 11-HSD1 activity in obese, insulin resistant subjects.   "
194858|NCT00398632|"     Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors     (SSRIs). The hypotheses of this study are that:1. subjects with major depression or dysthymia     who are being treated with an SSRI and experiencing treatment-related sexual dysfunction will     experience less sexual dysfunction if they are switched to duloxetine, and 2. they will     experience either improved antidepressant response or no loss of antidepressant response.   "
194860|NCT00398658|"     Purpose: To evaluate the efficacy of combined intraocular injection of gentamycin and     clindamycin in prevention of acute posttraumatic bacterial endophthalmitis (APBE) following     penetrating eye injuries.      Design: Multicenter, randomized, double masked, controlled trial. Participants: Three hundred     forty six eyes of 346 patients with penetrating eye injury.      Method: Following primary repair, eyes were randomized to receive a 0.1 ml intracameral or     intravitreal injection of 40µg gentamycin and 45µg clindamycin (cases), versus intracameral     or intravitreal injection of 0.1ml balanced saline solution (controls). All patients received     standard prophylactic antibiotic therapy (systemic, subconjunctival and topical).      Main outcome measures: Occurrence of endophthalmitis within two weeks after primary repair.   "
194861|NCT00398671|"     This study shall investigate the feasibility of the use of cool-caps in the preclinical     setting in patients with successful primary cardio-pulmonary resuscitation Hypothesis:     cool-caps are efficient and feasible to use in the preclinical setting in patients after     successful CPR.   "
194862|NCT00398684|"     The purpose of this study was to assess the efficacy of a single dose of the drug nevirapine     (NVP) given to pregnant women at onset of labor and to their infant 48-72 hours after birth     in addition to standard oral zidovudine (ZDV or AZT) prophylaxis for the prevention of     mother-to-child transmission of HIV-1.   "
194863|NCT00398697|"     This is a study of the drug perifosine in combination with Gemcitabine. Perifosine is an oral     anti-cancer agent that has been used in more than 140 people, but has not been combined with     other drugs before this study. The study is designed to determine the highest dose of     perifosine that can be administered to people every day while they are on a Gemcitabine     regimen, without severe or prolonged nausea, vomiting and diarrhea. This study starts with     patients taking 50 mg/day and goes up to 150 mg/day. After the highest tolerable dose is     found, we will add 10 more patients at that dose.   "
194864|NCT00398710|"     This is a phase II study in relapsed/refractory WM patients treated with perifosine. It is     designed to assess the proportion of overall confirmed responses (CR + PR + MR) using a     two-stage phase II study design to permit early stopping of the trial if there is strong     evidence that the study regimen is inactive. In addition, it will assess toxicity of this     drug in patients with WM. Patients will receive perifosine 150 mg qhs daily. Patients will be     assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks.   "
194865|NCT00398723|"     The study offers narrowband UVB light therapy to patients who have 5% of their body involved     with vitiligo.      The hypothesis is that Narrowband UVB promotes melanocyte proliferation in vitiligo lesions.   "
194866|NCT00398736|"     To evaluate the use of sonographic inferior caval vein assessment in mechanically ventilated     septic patients.      Volume assessment in mechanically ventilated patients with inflammation is of major     importance to guide fluid therapy. The researchers investigated whether measurement of caval     vein diameter correlates with invasively assessed volume-based hemodynamic parameters.   "
194867|NCT00398749|"     The main purpose of this study is to evaluate the safety and efficacy (% response) of epoetin     alfa in the treatment of anemia in adults receiving chemotherapy for cancer.   "
194868|NCT00398775|"     The purpose of this study is to determine whether new blood test (procalcitonin) can help to     reduce unnecessary use of antibiotics in patients with unexplained fever.      Although fever is most commonly caused by bacterial infection there are multiple other     conditions that can cause fever. It can be caused by viral infection. It can also be caused     by other non infectious disease. Patients with malignancy, inflammation (such as gout or     arthritis), or clots in veins can present with fever. Occasionally medications themselves can     cause fever. If fever is not caused by infection antibiotics will not help. Instead they may     cause side effects such as diarrhea and allergic reactions. We want to determine whether     simple blood test (procalcitonin) can help us to make a difference between fever caused by     infection and fever caused by others (above mentioned) non-infectious problems. We also want     to determine whether such test would help us to reduce unnecessary antibiotic use and help us     to find faster the real cause of the fever.      A total of 90 patients with the unexplained fever will be participating in this study. This     study will involve single, additional blood test, performed only if patient continue to have     fever despite a few days of investigations and therapy with antibiotics.      Patients will be assigned by drawing to one of two groups. In the first group blood test     (procalcitonin) will help a doctor to decide whether to stop or continue antibiotics. If     procalcitonin level is high antibiotics will be continued and the doctor will most probably     order additional tests to determine the source of infection. If procalcitonin level is low     serious bacterial infection is unlikely. The antibiotics will be stopped and a doctor will     try to look for other cause of fever.      In the second group blood for the tests will be collected but not reported to a doctor. You     will be treated in traditional manner by a doctor.      By following this procedure we will be able to determine whether therapy guided by     procalcitonin level is as safe and possibly more effective than traditional approach. This     study does not involve any other tests or study medications. We will attempt to contact all     patients one month later by phone to determine whether you remain well after discharge.   "
194871|NCT00398814|"     This study is a Phase I trial in two parts. In part 1, a MTD to the combination of perifosine     and sorafenib will be determined. In part 2, with the MTD as a starting point, a group of     patients will be accrued with the goal of ensuring that they will be able to tolerate at     least three courses of therapy, which would make them evaluable for response in a Phase II     study.   "
194872|NCT00398827|"     The objective of this study is to evaluate the safety and efficacy of dexmedetomidine as     compared to placebo when used for the sedation of subjects requiring monitored anesthesia     care (MAC).   "
194873|NCT00398840|"     This is an open label, dose escalation study of ARQ 171 administered via intravenous infusion     (IVI) into a peripheral vein weekly.      Patients with advanced solid tumors, who are refractory to available therapy or for whom no     standard systemic therapy exists, will be enrolled.   "
194874|NCT00398853|"     The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis     of the study was to evaluate the effect of supplementing the diet of individuals with Type 2     diabetes with chromium picolinate and assessing the effect of the supplementation on insulin     sensitivity as assessed with hyperinsulinemic clamps   "
194885|NCT00398996|"     This is a randomized, open-label study comparing three existing treatment strategies of ART     initiation in HIV/TB co-infected patients:      Group 1: early initiation of ART with TB treatment, Group 2: initiation of ART upon     completion of the intensive phase of TB treatment, Group 3: initiation of ART upon completion     of the continuation phase of TB treatment      Approximately 700 men and women ≥ 18 years of age with documented HIV infection and     smear-positive pulmonary TB patients will be enrolled. Eligible TB/HIV co-infected patients     will be offered antiretroviral therapy (ART), starting at one of the three time points listed     above through the CAPRISA AIDS treatment programme which includes extensive counselling and     adherence support. The study participants will be followed for 18 months to assess the     primary study endpoint of the optimal time to start antiretroviral therapy (ART) in patients     on tuberculosis (TB) treatment by comparing clinical status (CD4+ cell count, viral load,     opportunistic infections.   "
196028|NCT00411658|"     Study no longer required   "
194875|NCT00398866|"     Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and     that is often low in people with osteoarthritis. Although hyaluronan has been used in     millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb.     The purpose of this study is to determine the safety and effectiveness of hyaluronan in     relieving arthritis symptoms at the base of the thumb and to compare it to corticosteroids     and local anesthetic.      The principle hypothesis is that treating osteoarthritis at the carpometacarpophalangeal     (CMC) joint with injectable hyaluronan will results in greater pain relief, higher patient     satisfaction, and better functional outcomes than treating with placebo injections (local     anesthetic) or with corticosteroid injections. Treating CMC osteoarthritis with     corticosteroid injections will result in greater pain relief, higher patient satisfaction,     and better functional outcomes than treating with placebo injections. Patients with worse     pre-treatment function will have less improvement and worse post-treatment results after     administration of corticosteroid or hyaluronan.   "
194876|NCT00398879|"     This is an exploratory phase 2, randomized placebo-controlled trial with stratification for     disease and chemotherapy type. The study is subsequently closed to enrollment in all arms     except patients with metastatic colorectal cancer which would be randomized to either     capecitabine plus perifosine or capecitabine alone.      The effects of perifosine may be manifested by increased time to progression, tumor     regression reflected in partial or complete responses, or a combination of these outcomes.     The primary goal of this trial is to obtain a preliminary and objective assessment of the     effects of perifosine on time to progression.   "
194877|NCT00398892|"     Hypothesis: that lipoic acid supplements taken orally will improve control of blood sugar     levels in people with type 2 diabetes.      This study will recruit 18 people with type 2 diabetes, whose diabetes is currently managed     on oral agents. Each subject will then either take placebo for 12 weeks followed by lipoic     acid for 12 weeks, or lipoic acid followed by placebo.      A blood test for overall diabetes control will be taken at the start and end of each 12 week     period, and the change in control will be compared for lipoic acid vs placebo.   "
194878|NCT00398905|"     Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The     administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that     risk, but heparins have to be applied by injections below the skin. The purpose of this study     was to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the     licensed drug enoxaparin and to find the optimal dose of BAY 59-7939 for the anticipated     phase III trials. Enoxaparin, a so-called low molecular weight heparin, is approved and     widely used in the area of thromboprophylaxis and was given once daily subcutaneously. In     this study 5 different doses of the investigational drug BAY 59-7939 were tested in     comparison to Enoxaparin. The following doses of BAY 59-7939 were tested: 2.5 mg twice daily     (5 mg total daily dose); 5 mg twice daily (10 mg total daily dose), 10 mg twice daily (20 mg     total daily dose), 20 mg twice daily (40 mg total daily dose) and 30 mg twice daily ( 60 mg     total daily dose). This study ran for approximately 7 months in a number of countries. In     total, 726 patients were enrolled in this study.   "
194879|NCT00398918|"     This is a pilot study in which our intent is to establish an alcohol administration     laboratory in which we will be able to test the effect of the anticonvulsant medication     zonisamide as compared to placebo on alcohol self administration and on cognitive functioning     in non treatment seeking heavy users of alcohol. Our first goal is to establish the safety of     zonisamide when used together with alcohol. Our second goal is to test the effect of an acute     dose of zonisamide on alcohol consumption and show that it may reduce the consumption of     alcohol. To achieve this goal we seek subjects with a history of heavy drinking to be tested     on the self-administration procedures described below in two sessions with either zonisamide     or placebo. These procedures will involve first, the administration of a challenge dose of     ethanol to evaluate the effect of alcohol on performance on neuropsychological tests. This     initial challenge will be followed by a period of alcohol self-administration in which the     research subject can choose to select either ethanol or another reinforcer, money.   "
194880|NCT00398931|"     This study was conducted among women who had previously received alendronate for 3 to 6 years     during the Fracture Intervention Trial (FIT). Participants in the FLEX study were randomly     assigned to receive alendronate (either 5 or 10 mg/day) or matching placebo during the next 5     years, in order to evaluate the effects of continuing or discontinuing alendronate treatment     on bone mineral density and biochemical markers of bone turnover.   "
194881|NCT00398944|"     The purpose is to determine wether an electronic decision support system based on national     guidelines is effective to improve the follow-up and the treatment of two conditions:     hypertension and diabetes, in primary care practices.   "
194882|NCT00398957|"     The primary objective of this study was to examine the OROSÂ® Hydromorphone HCL     pharmacokinetic (the way a drug enters and leaves the blood and tissues over time) profile     for dose proportionality after administration of 8mg, 16mg, 32mg and 64 mg tablets.   "
195147|NCT00403819|"     A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an     open label post study follow-up, to assess the efficacy and safety of Movicol in the     treatment of chronic constipation in children   "
194883|NCT00398970|"     Bronchoscopy of non visible lesions in the lung, have a low diagnostic yield. The use of     endoscopic ultrasound might increase the diagnostic yield. This prospective study randomises     between bronchoscopy with the use of a ultrasound miniprobe and bronchoscopy without the use     of a miniprobe in clinical practice at Haukeland University Hospital.      The study hypothesis:      The use of the ultrasound miniprobe will increase the diagnostic yield of bronchoscopy in non     visible lesions.   "
194884|NCT00398983|"     The goal of this clinical study is to find out whether continued therapy with decitabine     after achieving a remission in acute myeloid leukemia (AML) patients can help prolong the     remission and prevent relapse of the disease.   "
194886|NCT00399009|"     After removing the rectum at surgery, bowel continuity can sometimes be restored by an     anastomosis between the anus and the bowel. This anastomosis is most commonly created by the     use of surgical circular stapling instruments. In a retrospective pilot study the risk of     developing an acute leak in the anastomosis was increased with one of the most commonly used     instruments in Sweden as compared to the other brand in use. In the current study the patient     is randomized to either one of the instruments after a resection of the rectum for rectal     cancer.   "
194891|NCT00399074|"     Malaria is fatal and increases the risk of death among children with sickle cell anemia.     Chemoprophylaxis significantly improves quality of life in these children. In Uganda     Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due     to high levels of resistance throughout the country. Intermittent presumptive treatment with     sulfadoxine - Pyrimethamine a new approach to malaria prevention, has shown great potential     in reducing incidence of malaria and anaemia among high risk groups such as pregnant women     and infants. However no studies have been done in Uganda to determine if presumptive     treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with     sickle cell anaemia.      Hypothesis : Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly     chloroquine in reducing incidence of malaria in children with sickle cell anaemia.   "
194892|NCT00399087|"     This is a study of the drug perifosine given in combination with docetaxel. Perifosine is an     oral anti-cancer agent that has been used in more than 140 people. Docetaxel is a standard     chemotherapy agent used in many types of cancer. This study is designed to determine the     highest dose of perifosine that can be administered to people every day while they are     receiving docetaxel with or without a steroid called prednisone, without severe or prolonged     nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up     to 150 mg/day.   "
194893|NCT00399100|"     People who has been in a fire accident have been shown often to be cyanide poisoned as well     as poisoned with carbon monoxide(CO). According to recommendations from the Danish Health     Agency people who are CO poisoned must be treated with hyperbaric oxygen (HBO). We want to     see if HBO treatment can also treat cyanide poisoning.      The hypothesis is that as cyanide binds the same place in the mitochondria as CO cyanide will     be detached from the mitochondria like CO and diffuse back to the blood.This way it will be     easier to treat with hydroxycobalamin.   "
194894|NCT00399113|"     The purpose of this first-in-man study is to evaluate the safety of 188Re-PTI-6D2 in patients     with metastatic melanoma. All patients will receive a tracer dose of 188Re-PTI-6D2 in order     to provide information on how the monoclonal antibody is distributed throughout the body and     to assess tumor targeting. No therapeutic dose of radiation will be given in the first study.   "
194895|NCT00399126|"     This is a study of the drug perifosine given in combination with paclitaxel. Perifosine is an     oral anti-cancer agent that has been used in more than 140 people. Paclitaxel is a standard     chemotherapy agent used in many types of cancer. This study is designed to determine the     highest dose of perifosine that can be administered to people every day while they are     receiving paclitaxel in one of two regimens, without severe or prolonged nausea, vomiting and     diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day.   "
194896|NCT00399152|"     This study is a Phase I trial in two parts. In part 1, a MTD to the combination of perifosine     and sunitinib malate will be determined. In part 2, with the MTD as a starting point, a group     of patients will be accrued with the goal of ensuring that they will be able to tolerate at     least two courses of therapy, which would make them evaluable for response in a Phase II     study.   "
194983|NCT00400023|"     This is a Phase 1, open-label, randomized, 2-sequence, cross-over, pharmacokinetic (PK) study     evaluating the effect of the DPD inhibitory action of CDHP as an S-1 component compared with     FT alone on the PK of 5-FU in patients with advanced solid tumors. The study will be     conducted in 2 parts (Cross-Over Pharmacokinetic Phase and S-1 Extension Phase).   "
194897|NCT00399165|"     The protocol was designed to address the hypothesis that oral testosterone enanthate plus     dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In     addition, we will compare the gonadotropin suppression mediated by a dose of testosterone     enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in     the normal range throughout the day, with the same dose (800 mg once daily) administered once     daily. This larger once-daily dose is expected to result in a higher peak and lower trough by     the end of the dosing interval   "
194898|NCT00399178|"     To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who     are sub-optimally treated with current analgesic. Those patients may benefit from treatment     with a long lasting analgesic.   "
194899|NCT00399191|"     The objective of the study is to develop a simple, noninvasive test for evaluation of iron     absorption as a tool to determine the cause of iron deficiency anemia. Healthy, premenopausal     women with iron deficiency with or without anemia will be recruited for the study.     Participants will, over the course of two months, ingest an iron solution three times; after     each iron ingestion, participants will collect their stool and bring it to the study     investigators for assessment of iron content.   "
194900|NCT00399204|"     The study aims to see if there is any significant difference in the cardiovascular outcomes     in type 2 diabetes patients who are treated with pioglitazone or Metformin   "
194901|NCT00399217|"     The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous     implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter     defibrillator (ICD)for treating ventricular tachyarrhythmias. The S-ICD electrode and pulse     generator emulator will be briefly implanted and tested during the standard implantation     procedure of an ICD, but then the S-ICD system will be removed entirely.   "
194902|NCT00399230|"     To evaluate the effectiveness of NGT (Optive) vs. Systane Tears for patients with moderate to     severe dry eye disease.   "
194903|NCT00399243|"     This study's hypothesis is the 4mg StatDose sumatriptan is effective for the acute treatment     of cluster headache and provides good safety and tolerability across multiple doses of the     study medication as well as across multiple attacks of cluster headache. This study seeks to     determine the safety and efficacy of the commercially available 4mg StatDose formulation of     sumatriptan as an acute treatment of cluster headache. Patients are allowed to use repeated     dose of the study medication for a given headache if they have had a partial response to the     first dose. They may treat up to 3 attacks of cluster headache with the study medication.     Safety assessment will be through adverse event reporting and physical examination. Patients     with both episodic cluster headache as well as chronic cluster headache will be studied.     Patients must either not have started preventive treatment for cluster headache or be on a     stable dose of preventive medication.   "
194904|NCT00399256|"     Background Prevention of contrast media (CM) induced nephropathy (CIN) by pharmacological     prophylaxis (e.g. N–acetylcysteine; NAC) is controversially discussed. So far, in all     interventional studies assessment of kidney function was based on measurements of serum     creatinine although this surrogate biomarker has several limitations. We investigated the     antioxidants NAC and zinc (Zn) for the prevention of CIN by monitoring concomitantly serum     levels of creatinine and cystatin C.   "
194905|NCT00399269|"     To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic     Renal Failure.   "
194906|NCT00399282|"     The purpose of this study is to determine whether simultaneous supplementation with omega-3     fatty acids and vitamin E is effective in the treatment of patients with rheumatoid     arthritis.   "
194907|NCT00399295|"     The purpose of this study was to compare the pharmacokinetic (the way a drug enters and     leaves the blood and tissues over time) profile of Dilaudid OROS 16mg (Dilaudid Slow Release;     hydromorphone HCL) administered under fasting conditions, following a high-fat breakfast     meal. The study also examined the effect of naltrexone blockade on the pharmacokinetic     profile of Dilaudid SR.   "
194908|NCT00399308|"     This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg     ulcers and to give preliminary information about the efficacy of two different Celaderm(TM)     dosing regimens.   "
194909|NCT00399321|"     The main purpose of this study is to see what levels of Bone Mineral Density post-menopausal     women with breast cancer have, and to see if the level of Bone Mineral Density changes during     a women's treatment after her surgery.      This trial studies changes in Bone Mineral Density and markers of of bone activity in     post-menopausal women receiving treatment for early stage breast cancer.   "
194910|NCT00399334|"     The purpose of this study is to evaluate epidemiological characteristics of patients that     experience relapse and need an admission in psychiatric acute units across Spain.   "
194911|NCT00399347|"     The prevalence and incidence of diabetes has been reported to vary among     populations.Immigrants groups as that have undergone significant life-style changes tend to     develop diabetes within a short time. The aim of the study is to assess the prevalence of     diabetes mellitus in Ethiopian population ,15-20 years after immigration in Israel.   "
194912|NCT00399360|"     A healthy diet and exercise have improved the health of people without human immunodeficiency     virus (HIV) who have Metabolic Syndrome. In this study we would like to find out if the same     benefit can be seen in people with HIV and Metabolic Syndrome. Patients with Metabolic     Syndrome usually have a large waist, high blood cholesterol levels, high blood pressure, and     high blood sugar levels. These are risk factors, which may increase one's chance of     developing heart disease and/or diabetes. The purpose of the study is to evaluate the effects     of different methods of treating HIV associated Metabolic Syndrome. The groups are: 1) a     lifestyle modification program plus metformin (also known as glucophage), 2) lifestyle     modification plus placebo, 3) metformin alone or 4) placebo alone. The lifestyle modification     program consists of nutrition and exercise sessions with the goal of improving body     composition, heart health, and ways to lower the risk of developing diabetes.   "
194929|NCT00399581|"     Acute respiratory distress syndrome (ARDS) is a severe lung condition that causes respiratory     failure. Individuals with ARDS often require the use of an artificial breathing machine,     known as a mechanical ventilator. High frequency oscillatory ventilation (HFOV) is a form of     mechanical ventilation that pumps small amounts of air into the lungs at a constant high     rate. The purpose of this study is to compare the safety and efficacy of two HFOV methods in     individuals with ARDS.   "
194913|NCT00399373|"     The study seeks to measure the effect of increased coordination of care on medical costs,     treatment utilization and selected clinical indicators among a Medicaid population with     chronic medical conditions and substance abuse problems? We shall address this question by     conducting a demonstration project consisting of the provision of integrated care management     (somatic and behavioral) to Medicaid enrollees living on the Eastern Shore of Maryland and     who have both chronic medical conditions and problems with substance abuse. A specific     component of the study will be the participation of Maryland’s Mental Health Administration     (MHA) and MAPS, the administrator of psychiatric services for the Medicaid enrollees in     Maryland. We shall compare the results of the integrated care management for the study sample     on the Eastern Shore with a control group from the counties of western Maryland.   "
194914|NCT00399386|"     The primary goal of this protocol is to collect ECG signals from paediatric patients using 4     surface electrodes placed in the configurations proposed for the Cameron Health, Inc.     subcutaneous implantable defibrillator (S-ICD) system. These signals will then be used to     test the S-ICD system for future use in paediatric patients.   "
194915|NCT00399399|"     To assess the efficacy of systemic corticosteroids alone as first-line treatment of     Churg–Strauss syndrome without poor-prognosis factors as defined by the five-factor score     (FFS=0), and to compare the efficacy and safety of azathioprine vs pulse cyclophosphamide as     adjunctive immunosuppressive therapy to treat failure or relapse   "
194916|NCT00399412|"     The purpose of this study is to collect surface electrograms from standard and several     non-standard configurations in patients with long QT syndrome, heart failure, cardiac     resynchronization therapy or wide QRS during a routine outpatient assessment. The ECGs     collected will be used as test signals by the sponsor for the development of a subcutaneous     implantable defibrillator   "
194917|NCT00399425|"     To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the     treatment of chronic foot ulcers in diabetic patients.   "
194918|NCT00399438|"     The primary purpose of this study is to evaluate the effects of BMS-562086 on small bowel and     colonic transits in female subjects with diarrhea-predominant irritable bowel syndrome     (D-IBS)   "
194919|NCT00399451|"     The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of     pharynx for OSAS & SS,to reduce pharyngeal compliance.   "
194920|NCT00399464|"     The primary objective of the study is to demonstrate the superiority of SL77.0499-10 10mg     once daily over placebo and the non-inferiority versus tamsulosin hydrochloride after 12     weeks treatment in terms of the efficacy in patients with lower urinary tract symptoms     related to BPH.      The secondary objective is to assess the safety of SL77.0499-10 in patients with lower     urinary tract symptoms related to BPH in comparison with placebo and tamsulosin     hydrochloride.   "
194921|NCT00399477|"     Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at     their first visit based on the drugs they are taking for their PD:        -  Group 1 Patients using Azilect and no other therapy.        -  Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip.   "
194922|NCT00399490|"     Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have     previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624     on an open-label basis.   "
194923|NCT00399503|"     This study evaluates the usefulness of noninvasive tests of the structure of the heart and     the nervous system controlling the heart. It will assess whether combining tests that     evaluate heart structure with others that measure the nervous system controlling the heart     will identify most patients who develop serious heart rhythm problems after a heart attack.   "
194924|NCT00399516|"     The primary objective of this study is to assess the effects of varying pulse width in     suprathreshold dorsal column stimulation in patients with low back pain.   "
194925|NCT00399529|"     This is a feasibility study to examine combination therapy with Trastuzumab (T),     Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine in     patients with Stage IV HER-2/neu-overexpressing breast cancer. The main purposes of this     study are to test the safety, clinical benefit, and bioactivity of vaccine therapy in     combination with Cyclophosphamide and Trastuzumab in patients with HER-2/neu-overexpressing     Stage IV breast cancer. This study will also to test whether the Cyclophosphamide can     eliminate the suppressive influence of regulatory T cells, and whether Trastuzumab can     increase antigen processing and presentation. These drug activities may make the immune     system react better and enhance the effects of the vaccine in treating breast cancer. The     vaccine consists of two irradiated allogeneic mammary carcinoma cell lines genetically     modified to secrete human granulocyte-macrophage colony stimulating factor (GM-CSF). This     open label, single arm study is designed to recruit up to 40 subjects to identify 20 research     subjects with HER-2/neu-overexpressing Stage IV breast cancer eligible for study treatment.   "
194926|NCT00399542|"     The primary purpose of this study is to evaluate the efficacy and safety of administration of     lubiprostone in patients with irritable bowel syndrome with constipation.   "
194927|NCT00399555|"     There have been many improvements in the care of children with hypoplastic left heart     syndrome (HLHS). This has helped these children survive longer. Because these children now     live longer, researchers are recognizing developmental disabilities (the children are behind     in their thinking or physical activity) in children with hypoplastic left heart syndrome. The     purpose of this research study is to help the investigators learn more about developmental     disabilities in children with hypoplastic left heart syndrome.      During the time of your child's first surgery for hypoplastic left heart syndrome, a monitor     was placed on your child's forehead to measure the oxygen levels in the brain. This monitor     is called Near Infrared Spectrometry (NIRS). The researchers involved in this study want to     know if oxygen levels in the blood vessels of the brain have any effect on developmental     disabilities later in life in children with hypoplastic left heart syndrome. The researchers     plan to enroll 60 research subjects.   "
194928|NCT00399568|"     This study will be investigating the efficacy and safety administration of multiple doses of     intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.   "
195010|NCT00402025|"     The purpose of the study is to assess the safety of injections of talimogene laherparepvec     into patients with pancreatic cancer that cannot be removed by surgery. The study will also     test whether the injections are effective in treating the tumor.   "
194930|NCT00399594|"     Identifying & optimizing strategies to reduce the burden of heart failure is vital. Despite     advances in pharmacotherapy, patients with heart failure are at high risk for death &     hospitalization. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical     activity, improves cardiac output & reduces HF symptoms. However, ~50% of patients do not     clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an     important reason for non-response.      This study will assess whether targeted LV lead placement will result in an increased     probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement.   "
194931|NCT00399607|"     The study team has developed a set of biomarkers of risk for colon cancer; this study tests     1) whether or not calcium and/or vitamin D supplementation can favorably affect these     biomarkers in persons who are at higher than average risk for colon cancer (ie, have already     undergone the removal of colon growths, called adenomatous polyps, which are known to be     precursors to developing colon cancer), and 2) whether effects on the biomarkers predict who     will get new colon polyps or not.   "
194932|NCT00399620|"     Periodontitis is a chronic disease of the supporting tissue of the teeth, characterized by     bleeding and inflamed gingival, resorption of alveolar bone. This disease has a significant     impact of the quality of life as the teeth become progressively mobile and may fall out     spontaneously if no treatment is provided. Periodontal disease has been cited as the sixth     complication of diabetes mellitus.Chromogranins / secretogranins are a family of proteins     present in nervous endocrine and immune cells, released with catecholamines during stress     situations. Chromogranin A (CGA) is the major member of this family.The aim of this study is     to determine the level of CGA and its derived peptides in the gingival crevicular fluid (GCF)     of health or diabetic patients with and without periodontitis.Then, we want to determine the     antimicrobial activity of these peptides.   "
194933|NCT00399633|"     The study aim at examining whether Sumatriptan changes the plasma values of the neuropeptides     vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary     adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2     og PGF2α.   "
194934|NCT00399646|"     The purpose of the Metricath Gemini System is to pre-dilate the target treatment area, take     arterial lumen measurements in a native section of artery or within the deployed stent and     perform further dilation of the deployed stent if required. In this manner, the Metricath     Gemini System can assist the Interventionalist by providing arterial measurements prior to     stenting, performing pre-stenting angioplasty, taking within stent measurements to help     determine if the stent is fully deployed, and by performing post-stenting dilations to     further dilate the stent if required.   "
194935|NCT00399659|"     This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation     (OIC) in patients with non-cancer pain.      Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA)     receive the treatment as follows:      Patients on tegaserod 6 mg twice daily (b.i.d.) or 12 mg once daily (o.d.) in the core study     will remain on the same dose in the extension (double-blind).      Patients on placebo during the core study will receive tegaserod 12 mg o.d. (open-label)      Patients who enter this study AFTER the core study interim analysis will receive the selected     tegaserod dose regimen (open-label) determined by the core study IA.   "
194936|NCT00399672|"     Although injection drug users (IDUs) account for over 70% of new cases of HCV infection/year,     there is no consensus on how to approach their medical care. In some Canadian centres,     patients must be free of recreational drug use for as long as 6 months before being     considered for HCV therapy. This is not consistent with current North American guidelines.     Over the past 5 years, we have developed a successful program for the treatment of HIV     infection in this population, based on a multi-disciplinary comprehensive program including     directly observed therapy (DOT). Even though the duration of therapy for HCV is shorter than     for HIV (as little as 6 months vs. life-long), we must address issues of administration of a     weekly injection (interferon), twice daily pills (ribavirin) and the risk of significant side     effects (including anxiety and depression) to successfully expand our program to treat this     disease. Further, it may be that even if the program is successful, its benefits will be     negated by HCV re-infection due to continued risk behaviors for its transmission.   "
194937|NCT00399685|"     The purpose of this study is to administer a combined oral contraceptive containing ethinyl     estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to     assess if the concentrations of the oral contraceptives change. The safety of this treatment     regimen will also be studied.   "
194938|NCT00399698|"     This study was developed in order to assess the effects of risperidone (Risperdal) as     compared with placebo on cognitive-motor performance (attention, memory, and hand steadiness)     and body movements.      We propose to study the effects of risperidone on cognitive-motor performance in children     already medicated for severe conduct problems. We would also like to look at safety by     assessing these children for dyskinetic movements. We already have a sizable cohort of     children maintained on risperidone. Our hypotheses are as follows:        1. Risperidone will have no adverse effects on cognitive-motor performance in children who          have received maintenance therapy for 4 to 20 months.        2. Children tested during placebo will show no more dyskinetic movements than during          risperidone treatment (i.e., there will be no unmasking of tardive dyskinesia).   "
194939|NCT00399711|"     This trial is conducted in the United States of America (USA). This trial compares the     changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet     given as twice daily versus three times daily regimens or versus twice daily rosiglitazone     and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on     monotherapy.   "
194979|NCT00391612|"     This is an international clinical research study evaluating the safety and effectiveness of a     new procedure called airway bypass. The goal of this research is to see if airway bypass can     relieve hyperinflation (overfilling) of the lungs, thereby improving lung function and     reducing shortness of breath in patients with severe homogeneous (diffuse) emphysema. EASE     stands for Exhale Airway Stents for Emphysema.   "
195011|NCT00402038|"     To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in     patients with advanced medical illness.   "
196097|NCT00413504|"     To determine whether fondaparinux as monotherapy without warfarin is effective and safe for     long-term (90 days) treatment of DVT and/or PE, thus gaining new long-term experience and     data using fondaparinux.   "
194940|NCT00399724|"     Primary objective:        -  To determine the optimal treatment algorithm for the clinical use of insulin glargine          based on the incidence of severe hypoglycaemia.      Secondary objectives:        -  To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and          nocturnal hypoglycaemia.        -  To determine the difference in glycaemic control as measured by HbA1c and fasting blood          glucose between the treatment algorithms.        -  To determine the difference in glycaemic control as measured by HbA1c and fasting blood          glucose between baseline and end of treatment.        -  To obtain safety data on the use of insulin glargine in each treatment algorithm.        -  To measure change in subject weight and insulin dose between baseline and end of          treatment.        -  To determine subject quality of life and treatment satisfaction (sub-study)   "
194941|NCT00399737|"     Several milk proteins are precursors of peptides, released during fermentation, which possess     various biochemical and physiological properties. Among them, some peptides have been     reported to inhibit angiotensin-converting enzyme (ACE) in vitro (an enzyme implicated in     blood pressure regulation) and to lower blood pressure (BP). in hypertensive rats and in a     small sample of patients with hypertension. One possible mechanism for the BP lowering effect     is inhibition of ACE. Prior investigating BP lowering effect of these peptides in a large     cohort of hypertensive patients, it is necessary to assess in depth their potency to inhibit     ACE in vivo in humans and to compare it to that induced by a well-known ACE inhibitor.   "
194942|NCT00399750|"     A randomized, controlled, open-label multicenter trial to assess the safety and efficacy of 3     oxaliplatin-fluoropyrimidine containing regimens (mFOLFOX6; bFOL; XELOX) + Bevacizumab (TREE1     and TREE2) as first line therapy of advanced metastatic colorectal cancer.   "
194943|NCT00399763|"     The purpose of this study is to find out whether atomoxetine (also called Strattera) helps     teenagers (12-19) with Attention Deficit Hyperactivity Disorder (ADHD) and drug/alcohol     problems.   "
194944|NCT00399776|"     We hypothesize that antipsychotic induced hyperprolactinemia can decrease bone mineral     accrual and decrease bone mineral content (BMC) in adolescents on antipsychotic therapy.      Specifics Aims        1. To determine if antipsychotic therapy leads to decreased bone mineral accrual and          decreased bone mineral content in a group of adolescents on antipsychotic therapy by          comparing them to an ethnicity, gender and pubertal stage matched control group.        2. To determine the relationship between serum concentrations of prolactin, sex steroids          and bone turnover markers in adolescents on antipsychotic therapy and an ethnicity,          gender and pubertal stage matched control group.   "
194945|NCT00399789|"     This is a study of the drug perifosine that consists of 2 parts. The first part of this study     was designed to determine the highest dose of perifosine that can be administered to people     every week without severe or prolonged nausea, vomiting and diarrhea. This study started with     patients taking 900 mg/week and went up to 1800 mg/week. Part I of this study is completed.     The MTD had been determined and incorporated in Part II.      The goals in Part II are to:        1. Compare the gastrointestinal toxicity of 3 different dose-schedules and        2. Obtain preliminary information on the response rate of perifosine in non-small cell lung          cancer.   "
194946|NCT00399802|"     This is a 4-week study to examine the effects of a new experimental medication on women with     breast cancer and established bone metastases. This study will enroll approximately 45 women.   "
194947|NCT00399815|"     Chronic viral hepatitis C is a frequent liver disease. It is associated with variable degree     of hepatic fibrosis. To date, liver histology is still regarded as the gold standard to     detect, diagnose and quantify liver fibrosis. This requires to perform a liver biopsy. Severe     complications are associated to this procedure in 0.01 to 0.1% of cases. Because of this, the     repetition of the biopsy to evaluate the progression of the disease or the response to     treatment poses ethical questions. Also, liver biopsy only explore a minimal portion of the     liver and liver fibrosis, which is not homogeneous, may be under- or over-estimated.      To avoid risks linked to invasive technique and sampling errors associated to liver biopsy,     efforts are being made to develop non-invasive technology to detect and quantitate liver     fibrosis.      In this study we will perform in patients with chronic hepatitis C, serum tests, fibroscan     (elastography of liver parenchyma determined by ultra-sounds), and elastography of liver     parenchyma by MRI.      This study will allow        -  to determine whether non-invasive tests effectively measure liver fibrosis        -  to compare each non-invase test with results of liver biopsy        -  to determine whether a non-invasive test or a combination of non invasive tests may be          used to accurately evaluate liver fibrosis in patients with chronic hepatitis C.   "
194948|NCT00399828|"     The purpose of this study is to assess the efficacy of device TRI-ACTIVETM (DEKA M.E.L.A.,     Itália)in the treatment od cellulite and body contouring.   "
194949|NCT00399841|"     The primary objective of this study is to compare the efficacy and patient preference for     spinal cord stimulation (SCS) using the Precision device with the electrode array placed at     T7 versus placement at T8. Eligible patients will have chronic intractable pain in the back     or lower extremities and will have independently elected SCS as the next line of therapy.     There is some anecdotal evidence that the coverage of the paresthesia resulting from T7     placement is preferable to that obtained by the more commonly used T8 placement but there has     been no study to support this observation.   "
194950|NCT00399854|"     The purpose of this study is to perform a clinical assessment of the efficacy of the device     DHERMIA® (Industra Mecânica Fina Ltda)in the treatment of cellulite and body contouring   "
194951|NCT00399867|"     In vitro statins, inhibitors of the HMG-CoA-reductase, have been shown to overcome cell     adhesion mediated drug resistance at very low concentrations. The purpose of the study is to     investigate the in vivo efficacy of simvastatin as inhibitor of cell adhesion mediated drug     resistance. Patients refractory to ongoing chemotherapy will receive concomitantly     simvastatin and response will be monitored by paraprotein levels   "
194980|NCT00399984|"     Inhaled corticosteroids taken on a daily basis have been proven to be the most effective     treatment for children with persistent asthma. However, many pediatricians still do not     prescribe daily corticosteroids to their asthmatic patients; this can lead to poor health     outcomes among asthmatic children. This study will evaluate an interactive medical education     program that focuses on improving pediatricians' asthma management skills and on encouraging     increased corticosteroid use among their patients with asthma.   "
194952|NCT00399880|"     Coronary heart disease (CHD) is the leading cause of death in the United States. Most people     who die from CHD die of a heart attack. Acute coronary syndrome (ACS) is a term that includes     mild heart attacks, as well as other episodes of chest pain that may serve as a warning sign     for an upcoming heart attack.      There are many medicines that can help prevent and treat ACS. However, at least 25% of     patients don't take their medications as prescribed. When patients don't take their     medications, we say they are noncompliant or nonadherent with the treatment.      The period following hospital discharge is a vulnerable time for many patients. Patients are     often confused about what to do when they return home from the hospital. Many patients don't     take their medications correctly, or they don't take them at all. Patients with poor literacy     skills have more trouble than others, because it is harder for them to follow written     instructions. Overall, about half of the adults in the U.S. have poor literacy skills. It is     important to develop ways to help these adults manage their health better.      The purposes of this research project are 1) to learn more about the relationship between low     literacy and medication adherence after hospital discharge, and 2) to test a strategy     designed to help patients take their medicines more regularly. We will recruit consenting     patients hospitalized with ACS. We will measure their literacy skills, ask questions about     how they take their medicines, and measure other related factors like social support and     self-efficacy. Patients will then be assigned to 1 of 2 groups. One group will receive only     usual care at hospital discharge, which usually includes the nurse and physician briefly     reviewing the medication prescriptions. The other group will receive an illustrated daily     medication schedule and special, tailored counseling from a pharmacist at their time of     discharge. About 1 week after patients leave the hospital we will contact them by phone to     ask them questions about how they have been taking their medicines. We will get data from     patients records for 6 months to see if the intervention had an impact on their medication     compliance, blood pressure, cholesterol, and diabetes measurements.      If this study is successful, this simple strategy could be implemented by hospitals to     improve medication compliance after discharge. This study will also provide more information     about how patients' literacy skills affect their medication compliance.   "
194953|NCT00399893|"     The purpose of this study is to investigate over a 6 month period the effect of octreotide     therapy on food intake, sense of hunger, body weight, body composition, efficiency of burning     calories, biomarkers of weight regulation and growth hormone markers in children and young     Adults with Prader-Willi Syndrome(PWS).   "
194954|NCT00399906|"     The purpose of this clinical research study is to learn if BMS-582949 alone is an effective     treatment for moderate to severe psoriasis. The safety of the drug and the effectiveness of     each dose will also be studied.   "
194955|NCT00399919|"     Patients with peripheral artery disease have decreased blood flow to exercising muscle     causing pain. This decreased blood flow to the muscle affects the level of acylcarnitines     which in turn decreases the level of carnitine. Carnitine allows muscles to function     properly. This study will test the safety and efficacy of Propionyl-L-Carnitine taken in     combination with a monitored exercise training program.   "
195705|NCT00401323|"     The purpose of the study is to compare time to progression and overall survival after     treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the     first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of     the head and neck.   "
194956|NCT00399932|"     Non-alcoholic fatty liver disease (NAFLD) is now recognised as the hepatic complication of     the metabolic syndrome of insulin resistance. In some patients, the disease can progress into     steatohepatitis (NASH) which associates fatty liver, hepatocellular damage, chronic     inflammation and variable and progressive fibrosis. The latter can evolve into cirrhosis and     end-stage liver disease.      Thus the presence of fibrosis sign the severity of the disease, and therefore its accurate     detection is crucial for the identification of patients in need of treatment and appropriate     follow-up.      To date, histological examination of a biopsy of the liver is the gold standard in the     diagnosis of fibrosis. the procedure is however associated with significant complication in     0.01 to 0.1% of cases and with sampling errors because it analyses only a minimal portion fo     the liver.      The aim of the study is to evaluate, in a population of patients with the metabolic syndrome,     whether non-invasive tests may identify those with hepatic fibrosis.      At inclusion, serum tests, fibroscan (elastography of the liver by ultra-sounds) and     elastography by MRI will be performed. Those tests will be repeated within 2 months.      A liver biopsy will be performed if 2 out of the 3 (serum test, fibroscan or elastography)     tests are suggestive of hepatic fibrosis.      This study will allow to determine        -  whether hepatic fibrosis may be detected by non-invasive means in patients with          NAFLD/NASH.        -  whether there is a correlation between non-invase tests and liver biopsy for assessment          of fibrosis and it severity        -  whether the presence of fatty liver interfere with the results of the fibroscan and the          elastography.        -  whether there are metabolic factors associated with an increased risk of fibrosis in          this population.   "
194957|NCT00399945|"     This study assesses the aerosol delivery characteristics (measured by in vivo lung     deposition, nebulization time, serum tobramycin concentrations, and pharmacokinetic     parameters) and safety of tobramycin inhalation solution administered for inhalation by PARI     eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with     compressor) in healthy subjects and in subjects with cystic fibrosis.   "
194958|NCT00399971|"     Our hypothesis is that ex vivo activated immune cells would produce multiple known and     unknown potent hematopoietic cytokines, working in concert, these cytokines help stem cell     growth and differentiation. Additionally, these cells travel and home to bone marrow as well     as spleen and liver involved in hematopoietic activities, where direct cell-cell contact may     be beneficial.   "
194959|NCT00391352|"     Impaired short term memory, attention and concentration lapses, and slower processing of     information occur in up to 40-65% of patients with Multiple Sclerosis (MS). The quality of     life of individuals with MS is impacted to the degree with which they experience these     symptoms.      There are several medications approved by the United States Food and Drug Administration     (FDA) to treat MS symptoms and to modify (slow) disease course. Traditional approaches to     determining the effectiveness of medications used in treating MS rely on reports of the     number of relapses an individual experiences, as well as standard clinical tests, such as the     Kurtzke Expanded Disability Status Scale (EDSS).      This research study will look at whether the functional magnetic resonance imaging (fMRI)     scan can be used as a tool for measuring changes in the brain associated with treatment in MS     patients. Unlike a typical MRI which provides structural information about the brain, the     fMRI provides information about brain activity during performance of cognitive or motor     tasks.   "
194960|NCT00391365|"     The purpose of this study is to determine any functional outcome differences in patients who     have undergone surgical treatment for ankle osteoarthritis using surveys, step counts, and     laboratory gait analysis.      This study is closed to recruitment; follow-up procedures are completed; the study remains     open for data analysis. Enrollment was completed by August 2012.      As of July 2016 the study is currently analyzing data, and preparing a journal article for     publication.   "
194981|NCT00399997|"     The purpose of this study is to evaluate the effect of a primary healthcare intervention     called 'Exercise on Prescription' aimed at increasing level of physical activity in a     population of sedentary patients with increased risk of developing lifestyle diseases. The     effect is evaluated using both objective and patient-reported variables.   "
194982|NCT00400010|"     In a randomized controlled trial, patients recruited in a general hospital and fulfilling     criteria for alcohol dependence, alcohol abuse or at-risk drinking will be randomly allocated     to two conditions:(1) Transtheoretical Model (TTM)-based expert system group, patients     receive an individualized feedback on drinking norms, health-related risks and core     constructs of the TTM, augmented by a TTM-based manual, (2) Control group,receiving a booklet     on health behavior.      Outcome assessment will be conducted after 12 months. The hypothesis is that individualized     feedback leads to greater reduction in alcohol consumption and elevated readiness to change     at follow-up.   "
194961|NCT00391378|"     Between 1 and 5 percent of patients who have coronary artery bypass surgery suffer a stroke     following surgery, and 30 percent have new brain lesions that do not produce symptoms and are     seen only on MRI. In addition, up to 40 percent of patients develop long-term cognitive     impairment. This study will identify risk factors that predict whether a person undergoing     heart surgery will develop cerebral infarcts after surgery. It will also identify operative     and inflammatory factors that may alter the risk, and will evaluate whether the small lesions     are associated with cognitive decline at 6 months.      People 18 years of age or older who will undergo coronary artery bypass surgery (CABG), heart     valve replacement, or combined CABG and valve replacement procedure are eligible for this     study. Candidates must have no neurological or cognitive impairment before surgery.      Participants will undergo standard medical and surgical treatment as determined by their     physicians. In addition, they have the following procedures:        -  Medical and neurological evaluation before surgery and 24 and 48 hours after surgery.        -  Brain MRI before surgery, and 48 hours, 30 days and 6 months after surgery.        -  Blood draws before surgery, immediately after surgery, and 6, 24, 48 and 72 hours after          surgery to quantify the response of their inflammatory system to surgery.        -  Neuropsychological examinations 30 days and 6 months after surgery.        -  In addition, patients who agree to enroll in a substudy that will explore whether          differences in the genes coding for inflammatory molecules lead to a change in the risk          of iscjhemia after heart surgery, will have extra blood drawn for genetic analysis.   "
194962|NCT00391391|"     Primary Objective:      To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine     to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.      Secondary Objectives:        -  To describe the immunogenicity of of Investigational Fluzone vaccine to the standard          Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.        -  To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone®          vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.   "
195739|NCT00401765|"     The purpose of this study is to determine the safety of docetaxel and CNTO 328 when given     together as a treatment. The second goal of this study is to determine if a combination of     docetaxel and CNTO 328 has an effect on prostate cancer.   "
194963|NCT00391404|"     Survivors of childhood cancers face a variety of long-term problems. The investigators'     recent study found that osteoporosis and osteopenia were common among these patients. The     factors leading to, as well as the best treatment option for, this morbidity are unclear.     Bisphosphonates are currently the standard therapy for osteoporosis in the elderly. However,     the efficacy and safety of bisphosphonates for treating osteoporosis in long-term cancer     survivors have not been tested. The investigators hypothesize that alendronate, an orally     active bisphosphonate, is efficacious and safe in the treatment of osteoporosis in these     patients.   "
194964|NCT00391417|"     The purpose of this study is to determine the efficacy and safety of a topical estradiol gel     for the treatment of hot flushes in postmenopausal women.   "
194965|NCT00391430|"     This study will evaluate which parts of the brain are affected by treatment with behavioral     therapy versus medication therapy in people with post-traumatic stress disorder.   "
194966|NCT00391443|"     BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group,     placebo-controlled, event-driven, group sequential, phase III superiority study. The primary     objective is to demonstrate that bosentan delays disease worsening or death in patients with     Idiopathic Pulmonary Fibrosis.   "
194967|NCT00391456|"     Effects of complementary therapies on heart failure, a leading cause of hospitalization, are     unknown. Animal-assisted therapy improves physiological and psychosocial variables in healthy     and hypertensive subjects.      The purpose of this study was to determine whether a 12-minute hospital visit with a therapy     dog improves hemodynamics, lowers neurohormone levels, and decreases state anxiety in     patients hospitalized with heart failure.   "
194968|NCT00391469|"     The overall goal of this study is to determine whether initiating hypothermia in cardiac     arrest patients as soon as possible in the field results in a greater proportion of patients     who survive to hospital discharge compared to standard prehospital/field care.   "
194969|NCT00391482|"     The purpose of this study is to determine whether a six-session, small group behavioral     intervention based on peer-volunteer activism is effective in (1) decreasing distributive     sharing of syringes and other injection paraphernalia and (2) increasing utilization of     HCV-related healthcare services among HCV-infected injection drug users   "
194970|NCT00391495|"     The aim of this study is to investigate the inflammatory response in children with this     disorder.   "
194971|NCT00391508|"     Peristomal skin complications are thought to be common but the exact frequency and cause of     these complications are unknown. We have sought to document the incidence of cutaneous     peristomal problems and to find risk factors that might contribute to peristomal     complications.   "
194972|NCT00391521|"     This is a Phase I trial. Some specific protocol information is proprietary and is not     publicly available at this time. Full information will be provided to trial participants.   "
194973|NCT00391534|"     This study is intended to investigate the safety and efficacy of a novel formulation of     oxcarbazepine that is released more slowly than the current formulation. The study medication     will be used as a treatment against partial epilepsy.   "
194974|NCT00391547|"     The primary purpose is to demonstrate the efficacy of a prescription mouthrinse in human     subjects for treatment of Gingivitis.   "
194975|NCT00391560|"     This is a Phase II trial designed to determine the efficacy and safety of perifosine in     patients with leukemia who develop progressive disease or recurrence while receiving therapy.   "
194976|NCT00391573|"     To compare the use of polyglactin sutures versus nylon sutures for conjunctival autograft     suturing in pterygium surgery.   "
194977|NCT00391586|"     This study was conducted to compare the activities of erlotinib to that of intravenous,     platinum-based therapy in the treatment of non-small cell lung cancer (NSCLC). The goal of     this trial was to demonstrate clinical equivalence of erlotinib to platinum-based frontline     therapy, compared to historical controls.   "
194978|NCT00391599|"     Enemas are not anymore used routinely before vaginal deliveries.The intention of this study     is to elucidate whether there is a benefit in routine use of enema before cesarean section.   "
195175|NCT00404183|"     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety     of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a     5-week dosing period in patients with osteoarthritis.   "
194984|NCT00400036|"     The objective of our research project is to determine the effects of fish protein, present in     fish, on insulin sensitivity in insulin-resistant human individuals, and its mechanism of     action on glucose metabolism. Our hypothesis is that fish protein improves insulin     sensitivity, glucose tolerance and plasma lipid profile through an improvement in a primary     defect in insulin signaling in overweight and insulin-resistant subjects.   "
194985|NCT00400062|"     This will be the first large cohort study to define the epidemiology of and identify     modifiable risk factors for long-term CI and functional deficits of ICU survivors. We will     measure the independent contribution of risk factors such as delirium and exposure to     sedative and analgesic medications to the incidence of long-term CI, controlling for     established risk factors (e.g., age, pre-existing CI, and apoE genotype). Defining the     contributions of these risk factors will make it possible to develop preventive and/or     treatment strategies to reduce the incidence, severity and/or duration of long-term CI and     improve functional recovery of patients with acute critical illness.   "
194986|NCT00400075|"     To assess the efficacy of systemic corticosteroids alone as first-line treatment of     polyarteritis nodosa and microscopic polyangiitis without poor-prognosis factors as defined     by the five-factor score (FFS=0), and to compare the efficacy and safety of azathioprine vs     pulse cyclophosphamide as adjunctive immunosuppressive therapy to treat failure or relapse.   "
195054|NCT00402597|"     The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent     acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the     occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions,     stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.   "
195114|NCT00403377|"     RATIONALE: Understanding why sunbathers use or don't use sunless tanning products may help     doctors plan effective ways to prevent skin cancer caused by sunbathing.      PURPOSE: This phase I/II trial is studying attitudes about the use of sunless tanning     products and how well sunless tanning products work as a substitute for sunbathing in healthy     participants.   "
194987|NCT00400088|"     This study is being done to look at how well people respond to two very different drug     treatments for depression. Clinically, people with depression can respond differently to drug     treatments for reasons which are not always clear. Some of our own recent research suggests     that people with depression who have a family history of bipolar disorder or completed     suicide, may react differently to standard antidepressant medications than those without such     a family history. Our data shows that family history of completed suicide, as well as the     known predictor of family history of bipolar disorder, may help identify a pre-bipolar high     risk group i.e. they currently have depression but at some future date will declare a bipolar     illness (manic-depression) by virtue of development of a manic episode also. Our research     suggests that treatment- emergent symptoms in response to a trial of antidepressant, such as     agitation may be strong predictors of future bipolarity and inherently dangerous particularly     as they are not ascribed to the antidepressant treatment. Finally, it is possible that this     subgroup of those with depressive illness may respond better and more safely to lithium, a     mood stabiliser used in known bipolar depression.      The objective of this proposal is to investigate response to acute lithium treatment in     subjects who meet the diagnostic criteria for major depression, but who are potentially at     risk for bipolar disorder, by virtue of family history of bipolarity or completed suicide.   "
194988|NCT00400101|"     Influenza virosomes represent an innovative human-compatible antigen delivery system that has     already proven its suitability for subunit vaccine design. The aim of the study was to proof     the concept that virosomes can also be used to elicit high titers of antibodies against     synthetic peptides derived from the circumsporozoite protein and from the     apical-membrane-antigen 1 and that the formulations are safe in humans.   "
194989|NCT00400114|"     The purpose of this study is to see whether or not the combination of cisplatin, irinotecan     and radiation, followed by surgery, followed by oral Sutent, is effective and safe for     patients with resectable esophageal cancer.   "
194990|NCT00400127|"     The objective of this study is to test the hypothesis that silicone suction suspension     without additional belt support does not significantly diminish the postural sway or walking     performance of persons with transfemoral amputation.   "
194991|NCT00400140|"     The objective of this pilot study is to establish whether brief periods of high levels of     acutely imposed myopic defocus can be used to slow the progression of myopia in children, as     measured by changes in spherical equivalent refraction and axial length.   "
194992|NCT00400153|"     The primary objective of this study is to compare the effect of ipratropium     bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20     mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20     mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of     12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to     COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent     Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent     Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed.     In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of     therapy will be characterized in a subgroup of patients.   "
194993|NCT00400166|"     The purpose of this study is to determine whether Recovery Guide support services are     effective in promoting recovery and social integration among psychiatrically disabled     individuals who experience high rates of inpatient hospitalizations.   "
194994|NCT00400179|"     This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating     the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced     gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be     randomly assigned (1:1) to S-1/cisplatin (experimental arm) or 5-FU/cisplatin (control arm).     Patients will be stratified by number of metastatic sites (one vs. more than one), locally     advanced or metastatic disease, prior adjuvant therapy (yes or no), measurable or     non-measurable disease, and center.   "
194995|NCT00400192|"     Individuals who experience a traumatic injury often have a significant amount of blood loss     and may require a blood transfusion. In some individuals who receive a blood transfusion,     white blood cells from the donor's blood may remain in the body for years, a condition known     as microchimerism. This study will examine the reasons why microchimerism occurs in some     blood transfusion recipients and not others.   "
194996|NCT00400205|"     This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel,     cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the     oral cavity to determine what effects these agents may have on cancer cells.   "
194997|NCT00400218|"     Evaluate the safety and anti-hypertensive efficacy of hyzaar(R) in patients with mild to     moderate essential hypertension.   "
195176|NCT00404196|"     To compare the efficacy and safety of two different dose combinations of LEO19123 cream     (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of     patients with hand eczema.   "
194998|NCT00400231|"     Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl     or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate;     or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target     dose. We are interested in the effects of these therapies on triglyceride levels, HDL-C,     insulin resistance, and markers of inflammation.   "
194999|NCT00400244|"     The purpose of this project is to develop French Canadian versions of the Wheelchair Skills     Program (WSP). Translating a measurement instrument in the field of biomedical sciences     requires not only the language to be taken into account but also the cultural context. We     will determine the measurement properties of the WST-F and complete the randomized controlled     trial on the efficacy of the WSTP-F.   "
195000|NCT00400257|"     The investigators are hoping to identify early heart failure in patients who do not have     symptoms as yet and at the same time assess the usefulness of Brain natriuretic peptide (BNP)     in doing this.   "
195065|NCT00402740|"     The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid     Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange     Embolic Protection System (Generation 5) and the Emboshield® BareWire™ Rapid Exchange Embolic     Protection System (Generation 3), in the treatment of atherosclerotic carotid artery disease     in high-surgical risk subjects.   "
195001|NCT00400270|"     All patients on the GP asthma database in one practice were invited for an asthma     physical-therapy assessment, at baseline. Volunteers satisfying the inclusion criteria ie -     aged between 16 and 70, able to understand, read and write English, give informed consent,     willing to attend the surgery to take part in the trial and with no other serious conditions     - were invited to participate in the study. Patients were randomised either to a control     group, receiving 2 more assessments at 6 and 12 months, or for comparison to a group     receiving 5 physical-therapy treatments of integrated breathing and relaxation exercises     (known as the Papworth Method (PM)). The two groups would then be compared at 6 and 12     months.      Hypotheses:        1. The PM of breathing and relaxation training would improve the quality of life for adult          patients with asthma in primary care, compared with patients only receiving usual          medical care.        2. Anxiety and depression, and symptoms from dysfunctional breathing would reduce compared          with the control group.        3. Respiratory function measurements would improve compared with the control group.   "
195002|NCT00400283|"     This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2     diabetes.   "
195003|NCT00400296|"     This single arm study will determine the maximum tolerated dose, and recommended dose for     further development, of R547, in patients with advanced solid tumors. Groups of patients will     receive ascending doses of R547 as weekly intravenous infusions administered over a) 90     minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of     dose-limiting toxicity following the starting dose, incremental dose-escalations will be     allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The     anticipated time on study treatment is until disease progression or dose-limiting toxicity,     and the target sample size is <100 individuals.   "
195004|NCT00400309|"     Primary objective:        -  To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis          vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus,          Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of          REPEVAX® administered one month after Placebo.      Secondary objectives:        -  To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy          adults.        -  To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after          Td-IPV vaccine (REVAXIS®) or one month after Placebo.   "
195005|NCT00400322|"     The purpose of this study is to investigate if treatment of CMV infection by antiviral drug     Valcyte (R) affects the clinical outcome of glioblastoma multiforme in patients with local     CMV infection in tumor tissue. The investigators' hypothesis states that CMV infection     promotes tumor development and disease progression and inhibits immune responses against the     tumor.   "
195006|NCT00401973|"     The goal of this study is to answer the following questions:        -  Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the          weight gain that is associated with olanzapine        -  Whether taking amantadine, metformin or zonisamide can help patients decrease or          eliminate some of the changes in body that occur with weight gain        -  How weight gain associated with olanzapine can affect people        -  Whether treatment with amantadine, metformin or zonisamide can help eliminate weight          gain associated with olanzapine and not interfere with the positive effects of          olanzapine on functioning of people with schizophrenia and other diseases   "
195007|NCT00401986|"     The primary purpose of this study is to gather additional safety data for the subjects     treated with the Alair System (hereinafter, Alair-Treated Subjects) who previously     completed the one-year study entitled: Multicenter Randomized Clinical Trial of Bronchial     Thermoplasty with the Alair System for the Treatment of Severe Asthma (Protocol #0903-27)     sponsored by Asthmatx, Inc. Subjects who elect to participate in this safety study will be     followed for an additional four (4) year period beyond the PREDECESSOR STUDY'S one-year     endpoint.   "
195008|NCT00401999|"     This study will examine the relationship between variations in a gene called OPRM1 and the     response to alcohol. The OPRM1 (Mu-opioid Receptor-1) gene helps regulate brain pathways     involved in experiencing pleasure. Brain pathways use a chemical called dopamine. Different     forms of the OPRM1 gene may lead to differences in how dopamine is released and subsequently     to differences in a person's response to alcohol.      Healthy non-smokers between 21 and 45 years of age may be eligible for this study. Candidates     are screened with a medical and psychiatric history and physical examination, blood and urine     tests, and breathalyzer (breath alcohol test). A blood test is also done to determine the     variant of OPRM1 gene.      Participants undergo the following procedures in three study sessions:      Session 1       Breathalyzer test, urine test for illicit drugs and pregnancy test for women who can become     pregnant.       Insertion of catheters (plastic tubes) into a vein in one arm for infusing alcohol and into     the other arm for drawing blood samples.       Completion of questionnaires on how intoxicated the subject feels.       Blood draw for research studies.       Eye movement test (a visor with a digital camera tracks the subject's eye movements while     he or she watches lights on a computer screen).       45-minute alcohol infusion (up to 0,08 grams per deciliter - a level considered in most     states as driving under the influence of alcohol).       Repeat breathalyzer, questionnaires, eye movement test and blood draw every 15 minutes     during the infusion and again after the infusion is complete.       Subjects remain in the clinic until their blood alcohol content falls below 0.02 g/dL,     determined by a breathalyzer test done every 15 minutes. Subjects can usually return home     about 3 to 4 hours after the alcohol infusion stops.      Sessions 2 and 3      The procedure is the same as for session 1, except subjects receive an infusion of alcohol     one session and an infusion of saline (salt water) the other. Also, subjects undergo positron     emission tomography (PET) scanning during the infusions. For this test, the subject lies on a     bed that slides in and out of a doughnut-shaped scanner. A custom-molded mask is used to     support the head and prevent it from moving during the scanning. A small amount of     radioactive substance called C-11 raclopride is injected through one of the catheters to     trace brain dopamine activity.   "
195009|NCT00402012|"     This study is designed to look at the effect of Pioglitazone treatment on the body's ability     to burn food in order to produce energy.   "
195012|NCT00402051|"     This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first     line combination therapy with either cisplatin or carboplatin in the palliative setting of     stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be     included in about 15 centers in Germany and randomized to one of the above treatment regimens     in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a     standard length of 21 days. Primary objective will be the Progression Free Survival Time of     patients as assessed in both treatment arms.   "
195066|NCT00402753|"     The proposed study in an inception cohort of patients with hematological malignancies treated     with PBSCT is designed to evaluate the effects of a physical exercise intervention on     muscular-skeletal, physical activity and quality of life outcomes.   "
196040|NCT00412750|"     To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon     alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to     peginterferon alpha-2a monotherapy.   "
195013|NCT00402064|"     The use of bisphosphonates during childhood to ameliorate the skeletal abnormalities     associated with osteogenesis imperfecta, idiopathic juvenile osteoporosis, fibrous dysplasia     of bone and cerebral palsy. There is paucity of long-term studies among children regarding     the safety and efficacy of bisphosphonates.      Osteomyelitis and necrosis of the jaws has been was discovered and reported as a serious     adverse event in bisphosphonate-treated adults patients.      To our knowledge, there is no report in the literature about osteomyelitis in children     treated with bisphosphonates and the influence of long term treatment with bisphosphonates on     children's jaws, the reaction to extractions and on the oral cavity.      Aim of the study: to examine the influence in the oral cavity of bisphosphonate in children   "
195014|NCT00402077|"     This study will examine the safety, tolerability, and body weight effect of subcutaneous     pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or     phentermine in overweight and obese subjects.   "
195015|NCT00402090|"     TPMT is a key enzyme in the metabolism of thiopurines. TPMT polymorphisms have been described     and are associated with a decrease activity of such enzyme. Therefore, a higher risk of     developing toxicity is present in patients requiring these drugs, which are indicated in     acute lymphoblastic leukemia, as well as, immunosuppressors after organ transplantation. The     frequency of heterozygotes polymorphisms ranges from 3 till 12 %, in different populations.     Homozygous patients have a lower frequency, estimated 1 in 300 individuals. The frequency of     such polymorphisms in mestizos mexican population has not been analyzed, and we considered     important to determine this frequency in healthy and patients requiring thiopurines,     particularly acute lymphoblastic leukemia.   "
195016|NCT00402103|"     To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg     / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood     Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).   "
195017|NCT00402116|"     There will be 2 phases in this study. Patients will either be enrolled to the first phase or     to the second phase, depending upon when they enroll into the study.      The first phase of this study is done to evaluate the safety of enzastaurin in patients. This     is done by gradually increasing the dose of the drug in small groups of patients and watching     closely for side effects.      In the second phase of the study, the dose determined to be safe will be used with     temozolomide during and following radiation therapy to see if the combination can help     patients with brain tumors live longer.   "
195018|NCT00402129|"     To report the safety and efficacy of 1064nm low fluence laser hair reduction for the     treatment of pseudofolliculitis barbae   "
195019|NCT00402142|"     1. To study the efficacy of a therapeutic HIV vaccine consisting of autologous myeloid          dendritic cells pulsed ex vivo with high doses of inactivated autologous HIV-1, in HIV-1          infected patients in a very early stages of the disease (CD4 > 450 x 10 6 /L).        2. To analyze the HIV-1 humoral and cellular immune responses induced by this immune-based          therapy.   "
195020|NCT00402155|"     Reading can be an uncomfortable and difficult task for some people. Symptoms include     unpleasant somatic and perceptual effects, such as eye-strain, headache, and blurred text,     despite normal visual acuity. This condition has been called Visual Discomfort, but little is     known about the symptoms and frequency of reading problems associated with this disorder.     Several studies have proposed that Visual Discomfort is caused by increased noise in the     visual system due to spreading cortical activation across different spatial frequency     channels. This study examines the prevalence and severity of visual discomfort in a college     student population and tests the noisy visual system hypothesis.   "
195021|NCT00402168|"     The purpose of this study is to learn if conversion to belatacept from cyclosporine or     tacrolimus will preserve kidney function in people who have had a kidney transplant. The     safety and tolerability of this treatment will also be studied   "
195022|NCT00402181|"     The purpose of this study is to evaluate the safety and efficacy of siltuximab in     participants with relapsed (the return of a disease or the signs and symptoms of a disease     after a period of improvement.) or refractory (cancer that does not respond to treatment)     multiple myeloma (a type of cancer that begins in plasma cells [white blood cells that     produce antibodies]).   "
195023|NCT00402194|"     A study of 12 weeks' treatment with losartan or placebo, to test the hypothesis that RAS     inhibition will improve insulin' vascular actions and therefore improve insulin sensitivity     in skeletal muscle.   "
195024|NCT00402207|"     Background Chronic inflammation in peripheral airways plays an important role in the     pathophysiology of asthma. Extrafine hydrofluoroalkane (HFA) beclometasone is distinguished     from other ICS because of its fine aerosol characteristics. As a result, there is a greater     extent of deposition of extrafine HFA-beclometasone in the peripheral airways. Therefore,     extrafine HFA-beclometasone may have an extra anti-inflammatory effect in children with     asthma.      Aim To analyse the potential extra anti-inflammatory effect of extrafine HFA-beclometasone     compared to HFA-flucticasone in children with asthma by means of alveolar nitric oxide (NO)     concentration and bronchial NO flux, inflammatory markers in exhaled breath condensate (EBC),     and conventional parameters.      Method In a cross-over study design of 6 months, 33 children, aged 6-12 years, with doctor     diagnosed mild persistent asthma, were treated with extrafine HFA-beclometasone inhaled from     an autohaler and HFA-flucticasone inhaled from a discus. Primary outcome parameters of this     study were; alveolar NO concentration and bronchial NO flux. Secondary outcome parameters     were inflammatory markers in EBC, lung function parameters, symptoms, presence and duration     of exacerbations and adverse effects. All parameters were recorded at baseline and after each     treatment period.   "
195078|NCT00402909|"     This study will assess the safety and efficacy of adding nateglinide to treatment with basal     insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone), for     patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin     and/or thiazolidinedione only.   "
195080|NCT00402935|"     RATIONALE: Comparing results of diagnostic procedures, such as ultrasound, done before,     during, and after chemotherapy may help doctors learn about the side effects of chemotherapy     and help plan the best treatment.      PURPOSE: This clinical trial is studying ovarian damage in young premenopausal women     undergoing chemotherapy for cancer.   "
195025|NCT00402220|"     The main treatment option for Treatment Resistant Depression is electroconvulsive therapy     (ECT) which is often effective but complicated by cognitive side effects, need for     anaesthesia and considerable stigma.      In recent years considerable efforts have been made to increase public awareness about     depression and increase access to services. However, the increasing number of patients     accessing treatment for depression in clinical services is also likely to be accompanied by a     sizeable increase in the number of patients with TRD. Despite the demand, relatively few     treatment options are available to such patients. One of the only substantially new     treatments developed for TRD in recent years has been the advent of repetitive transcranial     magnetic stimulation (rTMS). Repetitive TMS has been evaluated in over 20 trials conducted     over the last 10 years. Previous research indicates that rTMS has antidepressant activity;     however, the proportion of patients who respond to rTMS and the degree of treatment response     demonstrated in trials to date is limited. The limitations of these studies include     relatively small samples and limited duration of treatment (i.e., 2 weeks) as well as a lack     of long term follow-up. As rTMS is gradually entering use in routine clinical practice (for     example, recent regulation of its use in Canada), research is urgently required to establish     ways to enhance treatment response both in regards to the extent of response within     individuals and the proportion of individuals in whom rTMS has effects.      Stimulation site is another important treatment factor; thus far almost all of the trials of     rTMS in TRD conducted have evaluated the utility of high frequency left prefrontal cortex     (PFC) rTMS (HFL-TMS). In addition, several studies have evaluated the treatment efficacy of     low frequency rTMS to right PFC (LFR-TMS). In a previously published study we have     demonstrated that these two approaches have similar therapeutic benefit and both were     superior to sham stimulation.      A promising new approach to enhance efficacy involves combining LFR-TMS and HFL-TMS in a     sequential manner. We describe this as sequential bilateral rTMS (SB-rTMS). We have recently     published the results of the first substantial evaluation of SB-rTMS showing not only a     superiority to placebo in TRD but also a therapeutic response that is substantially superior     to response rates in most of the published studies of unilateral rTMS (>50% of patients     achieving standard criteria for clinical response compared to usually <30% in most studies).     In this proposed research study, we will directly test the hypothesis that SB-rTMS produces a     greater therapeutic response than HFL-TMS and compare both of these forms of stimulation to     placebo (i.e., sham) stimulation.   "
195026|NCT00402233|"     Primary objective: to assess the efficacy of pramipexole given two times daily compared to     placebo.      Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue,     impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the     tolerability among the treatment groups over 12 weeks   "
195027|NCT00402246|"     The purpose of this study is to determine whether the ability of clinicians to receive and     review information from patients implanted with a heart device over the internet (remote     care) is comparable to patients who are seen in-office for routine visits to check the status     of their device.   "
195028|NCT00402259|"     The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole     intravenous every 12 hours for 5 days in subjects with acute non-variceal upper     gastrointestinal bleeding   "
195029|NCT00402272|"     The purpose of this Clinical Evaluation is a continuation in the assessment of the     performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in     the treatment of patients with de novo coronary artery lesions.   "
195030|NCT00402285|"     RATIONALE: The use of lycopene, a substance found in tomatoes, or omega-3 fatty acid     nutritional supplements may keep cancer from growing in patients with prostate cancer.      PURPOSE: This randomized clinical trial is studying lycopene to see how well it works     compared to omega-3 fatty acids or a placebo in treating patients with stage I or stage II     prostate cancer.   "
195031|NCT00402298|"     This is a study of the safety and efficacy of MDMA-assisted psychotherapy in people with war     or terrorism-related posttraumatic stress disorder (PTSD).   "
195032|NCT00402311|"     The purpose of this study is to determine the effects and cost-effectiveness of a Diagnostic     Observation Center for PsychoGeriatric patients (DOC-PG). Our main hypothesis is that DOC-PG     has added value compared with usual care regarding Health Related Quality of Life (HRQoL).   "
195033|NCT00402324|"     Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of     both mania and depression more than treatment with mood stabilizer alone, in patients with a     mixed episode of bipolar I disorder.   "
195034|NCT00402337|"     The primary purpose of this study is to evaluate the efficacy and safety of administration of     linaclotide acetate in patients with chronic constipation.   "
195035|NCT00402350|"     The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a     single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a     single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Stage 2     is a randomized, doubleblind, placebo-controlled dose escalation of Staccato Fentanyl,     evaluating multiple doses of fentanyl. The three primary aims of the Phase I clinical trial     are to evaluate the pharmacokinetics (PK) and absolute bioavailability for Fentanyl, compare     the Staccato Fentanyl PK profile to the IV fentanyl PK profile, and examine the tolerability     and safety of Staccato Fentanyl in a non-opioid-tolerant, healthy volunteer population.   "
195036|NCT00402363|"     The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl     esters) in patients with recurrent, symptomatic atrial fibrillation.   "
195037|NCT00402376|"     Cardiac function may improve in patients with end-stage heart failure who receive long-term     support with ventricular assist devices (VAD). Reverse left ventricular remodeling may be     sufficient in some cases to allow explantation of the VAD. However, some questions continue     to await definitive answers. This study is designed to assess the myocardial recovery under     VAD support with optimal pharmacological therapy (high doses [group I] of statins,     beta-blockers, angiotensin-converting enzyme inhibitors versus standard doses [group II]).      The study is a randomized, single-blind trial performed at the Department of Cardiac Surgery,     University of Strasbourg, France. Twenty patients with end-stage heart failure who will be     supported by VAD (Thoratec paracorporeal device) as a bridge to heart transplantation will be     included. Reverse left ventricular remodeling and myocardial function will be studied by:     echocardiography, respiratory mitochondrial function, exercise testing, cardiac hormonal     function, and inflammatory response. Myocardial biopsies will be obtained at the time of VAD     implantation and heart transplantation. The follow-up will be performed every 4 weeks during     the VAD support period. The hypothesis of this trial is that reverse left ventricular     remodeling and myocardial function will improve under optimal medical therapy especially by a     high dose statin.   "
195038|NCT00402389|"     This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with     perinatal depression.   "
195039|NCT00402402|"     The purpose of the study is to estimate the usefulness of the QuantiFERON®-TB Gold test for     the diagnosis of latent tuberculosis infection in liver transplant candidates by correlating     the test results with risk factors for LTBI   "
195631|NCT00400335|"     The combination of testosterone and dutasteride is intended for use in hypogonadal men. This     study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone     administered with and without dutasteride   "
195040|NCT00402415|"     There are two drugs involved in this study. Sunitinib (Sutent(R)) is approved by the Food and     Drug Administration (FDA) for the treatment of advanced renal cell (kidney) cancer and     gastrointestinal stromal tumors. Sunitinib is thought to work by blocking the growth of blood     vessels into tumors; reducing the blood supply to tumors can slow their growth and sometimes     causes the tumors to shrink. Sirolimus has been approved by the FDA to prevent the body from     rejecting organ transplants. Sirolimus is being tested for its effects against cancer because     it can slow the growth of some tumors in animal models. Sirolimus is thought to slow cancer     growth in these animal models both by direct effects on the tumor cells, and also by blocking     production of growth factors that stimulate production of blood vessels. We hope that the     combined use of these two drugs will have better anti-cancer effects than either agent alone.     This study is designed to find out if different doses of Sirolimus combined with a standard     dose of Sutent are safe and well tolerated. Additionally, it is hoped to gain knowledge about     the way that Sutent(R) in combination with sirolimus affects the blood vessels produced by     cancer.   "
195041|NCT00402428|"     This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of     albumin interferon alfa 2b (alb-IFN)in combination with ribavirin compared with peginterferon     alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic     hepatitis C, genotype 1 who are IFNa treatment naive.   "
195042|NCT00402441|"     Primary Objective:        -  To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in          increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of          treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal.      Secondary objectives:        -  To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in          increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1          year of treatment in women who are 0.5-5 years postmenopausal        -  To assess the general safety of 35-mg risedronate administered once weekly.   "
195043|NCT00402454|"     To evaluate adherence and safety of three regimens of chemoprophylaxis for tuberculosis (TB)     in HIV-infected patients with positive tuberculin skin test.   "
195044|NCT00402467|"     The study drug, BAY59-7939, is a new drug currently being tested in the prevention of VTE. It     directly inhibits factor Xa, a blood component in the pathway which leads to coagulation     (clotting of blood cells). It is available as a tablet. The purpose of this study is to     compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed     drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used     in the area of thromboprophylaxis and will be given once daily subcutaneously. In this study     4 different doses of the investigational drug BAY59-7939 will be tested in comparison to     Enoxaparin. You will receive during the study either one of the following BAY59-7939     treatments or Enoxaparin. The following doses of BAY59-7939 will be tested: Dose I ; Dose II,     Dose III, Dose IV. This study will run for approximately 7 months in a number of countries.     In total, up to 600 patients may participate in this study.   "
195045|NCT00402480|"     The purpose of this study is to assess prospectively the efficacy of hydroxyurea therapy in     the setting of cerebrovascular disease, manifest as conditional or abnormal transcranial     doppler ultrasonography (TCD) flow velocities, in children with sickle cell anemia (SCA). TCD     is used to measure flow velocity in intracranial arteries as a marker of increased stroke     risk in children with SCA. The primary objective of this protocol is to determine whether     hydroxyurea reduces elevated TCD velocity.   "
195046|NCT00402493|"     The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal     Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using     Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.   "
195047|NCT00402506|"     The purpose of this study is to determine the effect of MC-1 on the combined incidence of     cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days     following coronary artery bypass graft (CABG) surgery compared with placebo.   "
195048|NCT00402519|"     To assess the role of interstitial brachytherapy alone compared to whole breast irradiation     in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning     local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control     rates in each arm are equivalent.   "
195049|NCT00402532|"     The purpose of this study is to determine whether Everolimus is effective in the treatment     and prevention of chronic graft dysfunction and chronic graft rejection after lung     transplantation.   "
195050|NCT00402545|"     The purpose of this research study is to determine the safest and most effective dose of 5-FU     that can be given with docetaxel (Taxotere), Cisplatin and cetuximab to patients with newly     diagnosed locally advanced squamous cell carcinoma of the head and neck. We will also be     studying the toxicity of this regimen of 4 drugs and the tumor response.   "
195051|NCT00402558|"     The goal of this clinical research study is to determine the safety and effects of giving a     special kind of immune cells called alloreactive natural killer (NK) cells with high dose     chemotherapy and allogeneic hematopoeitic stem cell transplantation with the goal of defining     the maximum tolerated dose of NK cells. The NK cells will be donated from a relative of yours     who has certain genetic type in their blood called HLA, that almost matches yours. The stem     cells you will receive will come from a separate HLA matched (HLA A, B, C, DR) relative or     unrelated donor. The safety of this treatment will also be studied.   "
195052|NCT00402571|"     The study objective was to determine whether liver injury develops in alcoholic patients who     ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from     two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3     consecutive days and remain in the facility an additional 2 days for monitoring. The primary     measures were aminotransferase measures taken at baseline and Days 2-5. We hypothesized that     there would be no difference in aminotransferase measures between the acetaminophen and     placebo study groups.   "
195053|NCT00402584|"     The purpose of this study is to examine the safety and efficacy of sibutramine in preventing     binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of     sibutramine in reducing body weight in subjects with binge-eating disorder.   "
196112|NCT00413712|"     The purpose of this study is to determine the efficacy and effectiveness of calcium channel     blockers and adenosine in the treatment of Supraventricular Tachycardia.   "
195055|NCT00402610|"     INTRODUCTION. To evaluate the efficacy of three regimens of prophylactic therapy for     tuberculosis in HIV-infected patients with anergy. METHODS. Prospective, multi-center,     randomized, comparative, and open clinical trial. Anergy was defined as absence of induration     in response to three antigens (PPD, Candida albicans and parotiditis antigen) applied by the     Mantoux method. Patients were randomized into one of the following prophylactic treatment     groups: isoniazid for six months (6H), rifampin plus isoniazid for three months (3RH),     rifampin plus pyrazinamide for two months (2RZ) or no treatment (NT). After completion of     treatment, patients were followed up for two years.   "
195056|NCT00402623|"     The exact cause of the chronic lung disease sarcoidosis is still unknown. Consequently, a     complete efficacious treatment is still not available. Earlier studies indicate an important     key role for oxidative stress, i.e. an imbalance between the production of and the protection     against ROS, in the etiology of sarcoidosis. Antioxidants, needed for protection against ROS,     are indeed lower in sarcoidosis. Therefore, antioxidant therapy to strengthen the reduced     antioxidant defense might be efficacious in sarcoidosis treatment. Since ROS are also capable     of initiating and mediating inflammation, antioxidant therapy might also mitigate the     elevated inflammation that occurs in sarcoidosis. The flavonoid quercetin possesses both     anti-oxidative and anti-inflammatory capacities and might therefore serve as a good candidate     for antioxidant therapy in sarcoidosis.      Therefore, the aim of the present study is to determine the effect of quercetin     supplementation in sarcoidosis patients on markers of both oxidative stress and inflammation.   "
195057|NCT00402636|"     The purpose of this study is to evaluate whether adding estradiol to rapamycin better     prevents coronary artery reblockage after drug-eluting stent implantation.   "
195058|NCT00402649|"     This study may provide safety information on a flu vaccine given to children and may provide     immunogenicity information to add to what was collected in a previous flu vaccine study.     Participants will include 55 healthy children, ages 2-10, who participated in 04-077 and     received a placebo injection instead of the flu vaccine or were incompletely immunized. The     study has 2 purposes: to make sure there are no serious side effects in children and to see     how the immune systems react to the vaccine. Study procedures include up to 4 study visits,     up to 9 follow-up phone calls, 2 blood samples to be collected during visits 1 and 3, and up     to 3 vaccine injections in the arm or thigh muscle. Parents will be given a memory aid card     to record side effects, temperatures, and medications. Parents will have the option for the     child to receive a 3rd dose of vaccine if offered, at month 6. This booster shot will require     a 6-month visit and participation for an additional 6 months.   "
195059|NCT00402662|"     The purpose of this study is to determine if the combination of everolimus and imatinib will     slow the growth of or cause a reduction in the size of the cancer, and to determine the side     effects of the combination in patients with melanoma. Each of the drugs in this combination,     if used alone, would not be expected to have an effect against the cancer. However, when used     together, there is a possibility that they could work together to damage the cancer cells, or     to block the formation or function of the blood vessels that feed the cancer, either of which     could result in slowing the growth of or shrinking the cancer. Both drugs work by blocking     signals that are sent from outside of a cell to the inside of the cell that direct the cell     to make certain substances to keep the cell alive. Cancer cells or blood vessels that feed     cancer cells may be more sensitive to drugs that block these signals.   "
195060|NCT00402675|"     In non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear.      Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and     others even showed a benefit of a selective invasive approach only in case of recurrence of     symptoms or a positive stress test.      The optimal timing of intervention is still matter of debate as a result of a randomized     clinical trial.   "
195061|NCT00402688|"     The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg     for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the     treatment of chronic prostatitis.   "
195062|NCT00402701|"     The purpose of this study is to determine whether a walking school bus program can increase     the number of children walking to school and decrease the number of children driven by car to     school.   "
195063|NCT00402714|"     This is a study to explore the use of a reduced intensity transplant conditioning regimen. A     conditioning regimen is the treatment that is given to prepare a body for the new bone marrow     that will be received from a donor. Reduced intensity conditioning uses lower doses of     chemotherapy than conventional conditioning regimens. The use of lower doses of drugs and     radiation cause fewer side effects. Reduced intensity regimens have been offered to older     patients or patients at increased risk for transplant-related side effects and have been     shown to be safe and effective. Reduced intensity conditioning regimens are now considered     for many patients who are undergoing transplant.   "
195064|NCT00402727|"     Patients, who are considered suitable by their physicians to take part in this research, will     have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples     taken, as well as a sample of the secretions or tissue around their infection site. In     addition, the site of the infection will be photographed. The patients will be randomly     assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under     evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e.,     one of the reference treatments for this kind of infection). The maximum treatment duration     will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients     will have a physical examination every day. On Day 3-5 during therapy as well as at the end     of treatment, the patients will have repeated examinations. These tests and evaluations will     be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine     samples will be taken only if judged necessary by the physicians.   "
195096|NCT00403143|"     To measure colour vision in patients with a blue light filtering lens implant in one eye and     non-tinted implant in the other eye (and compared this group with a control group with     bilateral non-tinted implants) and to determine whether blue light filtering lenses limit     colour vision   "
195113|NCT00403364|"     To assess if a sequential treatment regimen better eradicates H. pylori than does a triple     drug regimen in adults with dyspepsia or peptic ulcer disease.   "
195067|NCT00402766|"     Primary Objective:        -  To determine the maximum tolerated dose of the combination of cisplatin, imatinib          mesylate, and pemetrexed in metastatic malignant mesothelioma.      Secondary Objectives:        -  To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on tumor          tissue by:        -  histologic analysis of biopsy tissue        -  by non-invasive assessments of tumor vascularity performed before, during and after          treatment        -  electron microscopy analysis of endothelial cell architecture after patient treatment          with imatinib mesylate        -  To explore the effects of cisplatin, imatinib mesylate, and pemetrexed on surrogate          markers in serum.        -  To assess the rate of response to therapy.        -  To determine the doses of the combination regimen of cisplatin, imatinib mesylate, and          pemetrexed that enables de-phosphorylation of platelet derived growth factor receptor          (PDGF-R) on malignant mesothelioma tumor cells.        -  To determine the pharmacokinetic interaction between agents in this combination regimen.   "
195068|NCT00402779|"     The goal of this clinical research study is to learn if erlotinib hydrochloride (Tarcevaâ     (OSI-774 ) can prevent cancer in the mouth of people with a high risk of developing cancer in     the mouth. The safety of this drug will also be studied, as well as the drug's effect on     different cells in the body.   "
195069|NCT00402792|"     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety     of the administration of Extended-Release Hydrocodone/Acetaminophen compared to placebo over     a 48 hour dosing period in patients who have had bunionectomy surgery and to assess the     safety of the drug for 7 days after patients are discharged from the hospital.   "
195070|NCT00402805|"     The purpose of this study is to test the specific humoral response after an intramuscular and     intradermal influenza vaccination in lung transplant recipients   "
195071|NCT00402818|"     RESTORE is an observational, open-label, multi-center, prospective, study enrolling Raptiva®     (efalizumab) treated patients with moderate to severe chronic plaque psoriasis. The overall     duration of the study is approximately 4 years. Patients will be followed from the time of     study enrolment to study/treatment termination; thus active follow-up period will vary across     subjects. Raptiva® (efalizumab)treated patients with moderate to severe chronic plaque     psoriasis and meeting the inclusion/exclusion criteria specified will be eligible for     participation in this study.      Objectives:        -  To document and quantify the incidences of adverse events in this patient population        -  To explore the association of psoriasis treatments with changes in patient outcomes,          quality of life, and treatment compliance.   "
195072|NCT00402831|"     Primary objective:      To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two     doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in     terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days     following the second dose of ProQuad®      Secondary objectives:        -  To describe the antibody response rates to measles, mumps, rubella and varicella          measured 30 days following the first dose of ProQuad® administered by IM or SC route,        -  To describe the antibody titres to measles, mumps, rubella and varicella at 30 days          following the first dose and at 42 days following the second dose of ProQuad® both          administered by IM or SC route,        -  To describe the safety profile of two doses of ProQuad® both administered by IM or SC          route.   "
195073|NCT00402844|"     Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic     organs and vaginal walls to protrude. For decades, suture repair techniques have been the     primary choice of surgical treatment when indicated.      The notion of reinforcing pelvic floor defects using biomaterial implants is not an     exclusively contemporary idea. Traditional surgical techniques are frequently associated with     unsatisfying anatomical recurrence rates and over the years sporadic attempts have been made     to introduce novel surgical techniques using a variety of biomaterials as support with     varying success. It is plausible that inherently weak, or damaged, pelvic floor supportive     tissues need to be reinforced by a permanent support to avoid the high rates of recurrences     commonly described using traditional techniques. However, use of biomaterials in pelvic     reconstructive surgery has become widespread in just a few years despite a lack of clinical     safety data, or compelling clinical evidence demonstrating that it improves outcomes compared     to traditional suture techniques.      It is likely that biomaterials need to be anchored in tissues not afflicted by the disease,     in order to provide the intended pelvic floor support. This has given rise to transvaginal     surgical techniques using a transobturator approach passing the mesh through the arcus     tendineous fascia pelvis, or the sacrospinous ligaments through a transgluteal approach.     Already commercially available implant materials are in need of patient safety documentation,     both when considering the surgical techniques by which these materials are placed in the body     as well as the actual materials. Complication rates and perioperative morbidity using these     surgical routes in pelvic organ prolapse surgery are generally unknown.      The aim of the present study was to assess the long term morbidity, and describe the     complications, associated with transvaginal mesh repair of pelvic organ prolapse using the     PROLIFT®-system.   "
195074|NCT00402857|"     This study will evaluate the effectiveness of a parent training program in improving     parenting skills and reducing behavioral symptoms in young children who are at risk for     developing childhood behavior disorders.   "
195075|NCT00402870|"     The ProSeal laryngeal mask airway is a relatively new airway device with a modified cuff to     increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of     gastric insufflation and insertion of a gastric tube. In the following randomized prospective     double-blind trial, we test the hypothesis that the postoperative analgesic requirements is     higher for the ProSeal laryngeal mask airway than the tracheal tube.   "
195076|NCT00402883|"     The purpose of this study is to see if this combination of chemotherapy plus radiation     therapy and immunotherapy (with bevacizumab) expands treatment options for patients with     non-small cell lung cancer.   "
195077|NCT00402896|"     The goal of this clinical research study is to learn the effect of ZD6474 on the amount of     time between placement of an indwelling pleural catheter and the catheter's removal in     patients with malignant pleural effusion.      This study will also look at the effect that ZD6474 has on tumor cells, biological     characteristics of cells in the body, rate of fluid build-up around the lungs, tumor size,     and thickness of blood vessels. The effect that this drug has on quality of life and     shortness of breath will also be examined.   "
195079|NCT00402922|"     Coronary heart disease (CHD) is the leading cause of death in the United States. One common     risk factor for CHD is obesity. The presence of certain types of fat over others is more     commonly associated with the development of CHD. This study will use data from a previous     study to examine the association between pericardial fat, a type of fat that surrounds the     heart, and CHD.   "
196148|NCT00414193|"     Nosocomial bloodstream infections are important causes of morbidity and mortality caused by     AmpC beta-lactamase-producing Enterobacteriaceae. The information collected will optimize the     management of patients with nosocomial bloodstream infections.   "
195081|NCT00402948|"     This study will evaluate the efficacy, safety and tolerability of two dosages of a new drug     TPI ASM8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged     between 18-65, non-smokers . The study will also look at the nature and quantity of     inflammatory white cells in the lung secretions and in the blood, and some additional     inflammation markers.   "
195082|NCT00402961|"     The purpose of this study is to see whether acupuncture may help patients recover from colon     cancer surgery.   "
195083|NCT00402974|"     Background of the study:      Results from several studies show that vitamin K has an important function in bone     metabolism. In a previous cross-sectional study conducted by our department, evidence for a     poor vitamin K status of bone during growth in children was found (unpublished data, accepted     for publication Pediatric Research, october 2006). These findings justify clinical     intervention studies in which bone quality is monitored as a function of long-term vitamin     K-supplementation. Before a long-term intervention study is undertaken, it is important to     determine the effect of vitamin K administration on osteocalcin carboxylation in this     specific population. Although the relationship between increased vitamin K intake and     osteocalcin carboxylation was already clearly demonstrated in several adult groups (e.g.     healthy adults, postmenopausal women), this has never been shown in children.      Objective of the study:      To study the effect of a vitamin K-containing food supplement (menaquinone 7) on osteocalcin     carboxylation in healthy children between 6 and 10 years of age in the Netherlands.      Study design:      Randomised double-blind placebo-controlled intervention study.      Study population:      55 healthy children (boys and girls) between 6 and 10 years, recruited from primary schools.      Intervention:      The subjects are randomised into two groups:        -  placebo group: during 8 weeks, 27 children will receive one tablet of placebo- food          supplement per day        -  treatment group: during 8 weeks, 28 children will receive one tablet of food supplement          per day containing 45 µg vitamin K2.      Primary study parameters/outcome of the study:      Undercarboxylated (ucOC) and carboxylated (cOC) fractions of osteocalcin will be measured by     enzyme-linked immunosorbent assay (ELISA). Both the ucOC fraction and the ucOC/cOC ratio     (UCR) are sensitive indicators for the vitamin K status of bone. Elevated levels of UCR are     indicative of an inferior vitamin K status of bone. The main study parameters are the mean     percentages of change in serum undercarboxylated osteocalcin (ucOC) and UCR from baseline     (t=0) to endpoint (t=8 weeks) in both treatment groups.      Secondary study parameters/outcome of the study (if applicable):      The secondary end points are the percentages of change in serum vitamin K levels in relation     to lipid metabolism markers from baseline to endpoint in each individual.      Furthermore, the percentages of changes in serum BAP and NTX from baseline to endpoint in     each individual are considered to be endpoints as well.   "
195084|NCT00402987|"     We are proposing a study in which we utilize and augment the sore throat pain model to assess     the analgesic effectiveness of celecoxib compared to placebo in patients with painful     pharyngitis under randomized, double-blind, placebo-controlled conditions.   "
195085|NCT00403000|"     RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well dutasteride works in treating patients with     recurrent prostate cancer that did not respond to androgen-deprivation therapy.   "
195086|NCT00403013|"     The purpose of this study is to determine whether the axillary plexus block performed in     lateral, head down position is effective in the perioperative analgesia in patients scheduled     for elective surgery of the shoulder.   "
195087|NCT00403026|"     Bevacizumab is an anti-VEGF agent used in approved for use in metastatic colorectal carcinoma     (FDA Approved). This study analyzes the safety and efficacy of off-label Intravitreal     Injection of bevacizumab (Avastin) for CNVM, Macular oedema due to diabetic retinopathy,     vascular occlusion and other retinal disorders.   "
195088|NCT00403039|"     The purpose of this study is to examine the effects of Lucentis for active Central Retinal     Vein Occlusion with Macular Edema   "
195089|NCT00403052|"     The main objectives of this study are to establish a safe, tolerable and active dose of 1018     ISS administered in combination with irinotecan and cetuximab in patients with metastatic     colorectal cancer. Other objectives also include determining tumor response, time to disease     progression, and overall survival in treated patients.   "
195090|NCT00403065|"     RATIONALE: Steroid therapy, such as dexamethasone, may reduce swelling, pain, and other     symptoms of inflammation and may be effective in treating some of the problems caused by     cancer and cancer treatment. Supportive care improves the quality of life of patients with a     serious or life-threatening disease, and prevents or treats symptoms of cancer, side effects     of treatment, and other problems related to cancer or its treatment. Radiation therapy uses     high-energy x-rays to kill tumor cells. It is not yet known whether dexamethasone given     together with supportive care is more effective with or without whole-brain radiation therapy     in treating patients with brain metastases.      PURPOSE: This randomized phase III trial is studying dexamethasone and supportive care to see     how well it works with or without whole-brain radiation therapy in improving the quality of     life of patients with non-small cell lung cancer that has spread to the brain and cannot be     removed by surgery.   "
195091|NCT00403078|"     The primary objective of this study is to assess the outcomes of stenting with distal     protection in the treatment of obstructive carotid artery disease. The devices to be utilized     are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP     Emboli Capture Guidewire (ECGW).   "
195092|NCT00403091|"     Rural Diabetes Online Care (RDOC) will develop an Internet-based intervention for rural     primary care physicians, focusing on improving care for adult patients with diabetes. The     intervention, drawing upon the principles of quality improvement and providing tools for     system-based changes in practice, is designed for the rural practice, where resources are     constrained.   "
195093|NCT00403104|"     The purpose of this study is to determine if oral treatment with ONO-2506PO in patients     diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization,     could lead to the slowing of decline in respiratory function, functional status, muscle     strength, quality of life and survival compared with placebo group.   "
195094|NCT00403117|"     The purpose of this study is to determine if the subjective effects of marijuana will be     decreased by low-doses (< 25 mg) of naltrexone and increased by high-doses (> 50 mg) of     naltrexone.   "
195095|NCT00403130|"     Single-institution phase 2 trial investigating the efficacy of capecitabine, oxaliplatin and     bevacizumab for patients with metastatic neuroendocrine tumors.   "
195099|NCT00403182|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Estrogen can cause the     growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by     lowering the amount of estrogen the body makes. It is not yet known whether giving     chemotherapy before hormone therapy is more effective than giving hormone therapy before     chemotherapy in treating breast cancer.      PURPOSE: This randomized phase III trial is studying chemotherapy to see how well it works     when given before or after hormone therapy as first-line therapy in treating postmenopausal     women with metastatic or locally advanced breast cancer.   "
195100|NCT00403195|"     The purpose of this study is to characterize the disease Ocular Ischemic Syndrome.   "
195101|NCT00403208|"     Hypothesis: A protocolized algorithm for sedation in critically ill patients on mechanical     ventilation can decrease ventilator days, costs and improve outcome.      This is a multicenter observational-interventional study on critically ill patients who     require mechanical ventilation for more than 48 hours, involving 13 ICU in Chile. There are     two periods (groups): a descriptive phase of sedation practices, and an interventional period     in which an analgesia-based, goal-directed, nurse-driven sedation is applied.      Main outcome: ventilator-free days between both periods.   "
195102|NCT00403221|"     The purpose of this study is to conduct a Phase I clinical trial involving in situ RTVP-1     gene therapy for prostate cancer. We will conduct necessary safety evaluations on a new     adenovirus that contains the human genes for RTVP-1. This virus will then be evaluated for     safety in men with prostate cancer prior to radical prostatectomy. Based on the preclinical     data, we hope that this treatment will induce not only a local cytotoxic and antiangiogenic     effect but also, a systemic antitumor immune response capable of eradicating micrometastatic     disease (the reason for recurrence in many of these patients).   "
195103|NCT00403234|"     The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal     system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2)     the impact of BTDS on functional rehabilitative measures after total knee replacement     surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind     treatment period is for 28 days during which time supplemental analgesic medication will be     provided to all subjects in addition to study drug.      Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to     efficacy or safety. The focus of this study became safety evaluations.   "
195104|NCT00403247|"     The purpose of this study is to determine whether individuals with schizophrenia who will     take a high dose of the B-vitamins folate, B12 and pyridoxine, may experience improvement in     their symptoms.   "
195105|NCT00403260|"     The primary objective of this phase III study is to compare the efficacy and safety of the     fixed combination of pyronaridine artesunate (180:60 mg) with that of the combination of     mefloquine plus artesunate in children and adults with uncomplicated P falciparum malaria.   "
195106|NCT00403273|"     Primary Total Knee joint replacement surgery is highly successful surgery for relieving pain     and improving function in patients with disabling arthritis. Unfortunately, like all     biomedical devices, prosthesis failure is a complication of knee replacement surgery that     leads to disabling pain, stiffness and loss of function. Approximately 1% of the knee     replacements fail every year leading to a 20% failure rate over 20 years. The common causes     of failure of prosthetic joint are infection, loosening, trauma or wear of the prosthesis.     Currently, a revision surgery is the best option for long term pain relief (analgesics or     other pain medications are options but are of limited benefit). Surgery may not be feasible     in patients due to advancing age, other medical conditions and surgical/technical     difficulties or patient's choice. In addition, the results from revision surgery are not as     good as the initial knee joint surgery. Therefore, there is a great need for a novel,     targeted therapy that provides an option to patients who are unfit, unable, or unwilling to     undergo surgery.      In the investigators' recent pilot study, a single injection of Botulinum toxin A (Botox) in     painful natural knee, ankle and shoulder joints of patients with various types of arthritis     led to significant and durable improvement in pain and function and was safe to use. The     investigators propose this 6-month study to compare pain relief, improvement of function and     safety of an injection of Botulinum toxin compared to placebo in patients with a painful     prosthetic knee joint. Both patients and investigators will be blinded to the treatment     assignment to a patient until the study is completed. The investigators will assess the     amount and duration of pain relief, improvement in function and short term safety of     Botulinum toxin using standard validated measures. Patients will be evaluated at baseline, 2     weeks, 1-, 2-, 3-, 4- and 6-months after a single injection of either placebo or BoNT/A in     the hip or knee prosthesis. The six-month follow-up is to assess the duration of meaningful     pain relief. If successful, this will offer a new treatment option for patients with a     chronically painful knee prosthetic joint, provide more insight into the origin and cause of     pain in prosthetic joints and direct future investigations in new directions.   "
195107|NCT00403286|"     The purpose of the study is to determine the appropriate dose of fluticasone     propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone     propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in     blood plasma in patients with chronic obstructive pulmonary disease.   "
195108|NCT00403299|"     Heart transplanted patients often develop coronary artery disease and therefore have their     coronary arteries examined with coronary angiography once a year.The purpose of the study is     to validate computer tomography of the coronary arteries against coronary angiography and     intravascular ultrasound in heart transplanted patients. Additionally the association between     different inflammatory markers and the development of CAD specific to heart transplanted     patients will be studied.   "
195109|NCT00403312|"     Cigarette smoking is the most common risk factor for lung cancer, and it increases the risk     of developing other cancers, chronic lung disease, and heart disease. A smoking cessation     program that incorporates physical activity may be beneficial in improving long-term smoking     cessation rates. This study will evaluate the effectiveness of a community-based physical     activity program, in combination with nicotine replacement therapy and a behavioral smoking     cessation program, at improving cessation rates among sedentary smokers.   "
195110|NCT00403325|"     The purpose of this study is to examine the effects of Lucentis for active Central Serous     Chorioretinopathy.   "
195111|NCT00403338|"     1500 eligible patients will be treated with the commercially available CYPHER®     sirolimus-eluting Bx Velocity™ stent. Patients will be followed to twelve months     post-procedure, watching for patients that require a repeat procedure on the same diseased     area of the coronary artery.   "
195129|NCT00403585|"     This is an open label, single-arm, multi-centre extension study for Korean patients with     chronic hepatitis B and compensated liver disease who have completed one-year adefovir     dipivoxil treatment in ADF103814. The objective is to assess clinical efficacy and safety of     long term (up to 3 years) adefovir dipivoxil 10mg therapy.   "
195130|NCT00403598|"     The purpose of this study is to determine whether the serum levels of certain calcium-binding     proteins may be helpful in the diagnosis and management of metabolic bone diseases.   "
195112|NCT00403351|"     Estimating the risk of future cardiovascular events such as death, stroke and myocardial     infarction using traditional risk factors (such as age, gender, smoking, diabetes,     hyperlipidaemia and hypertension) is well accepted in patients with and without existing     cardiovascular disease. These estimates are based on a number of robust observational     studies, including the original Framingham study. While these methods apply reasonably well     on a population level their application to the individual patients is not always     straightforward. In addition, risk charts, such as those published by the Joint British     Societies and American Heart Association, may underestimate risk in certain groups, notably     diabetics and patients of Indo-Asian background, whilst overestimating risk in others (by as     much as 50% in some studies).   "
195115|NCT00403390|"     This study compares two different brands of thyroxine (thyroid hormone). Currently,     pharmacists may be substituting generic formulations of thyroid hormone without your doctor     knowing about this. Although a small difference in thyroid function is not significant in     most healthy children, adolescents and adults, in infants and toddlers even a small     difference in thyroid function can have important harmful consequences on brain development.     The purpose of the present study is to learn whether the difference between brands of thyroid     hormone that are currently being substituted is sufficient to cause a difference in thyroid     function.   "
195116|NCT00403403|"     This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary     evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or     carboplatin) and etoposide in patients with previously untreated extensive-stage small cell     lung cancer (SCLC).   "
195117|NCT00403416|"     This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections     after kidney transplantation, when combined with tacrolimus for the first 3 months and with     myfortic thereafter.   "
195118|NCT00403429|"     The purpose of this study is to evaluate the activity and the toxicity of capecitabine as     monotherapy in the treatment of platinum resistant or refractory ovarian cancer.   "
195119|NCT00403442|"     The purpose of this study is to explore the combination of PDT with verteporfin at reduced     and standard fluence rates, in conjunction with bevacizumab, in the treatment of subfoveal     CNV of all subtypes with a high percentage of subretinal hemorrhage (hemorrhage >50% of total     lesion area).      To assess the safety of bevacizumab in combination with verteporfin PDT (reduced fluence: 300     mW/cm2) as compared to bevacizumab in combination with verteporfin PDT (standard fluence: 600     mW/cm2) in patients whose neovascular CNV lesions containing >50% blood.   "
195120|NCT00403455|"     Dr. Wang's merit review is aimed at providing a better understanding of the relationship     between SLC6A3/SLC6A4 and the mental health of veterans exposed to high levels of combat     stress, specifically focusing on PTSD symptoms, related co-morbidities, treatment outcomes     and seeks new approaches to therapy for our Veteran population.   "
195121|NCT00403481|"     This study will examine the ability of olmesartan medoxomil to lower the blood pressure of     patients with Type II diabetes and high blood pressure. The medication being tested has been     approved by the FDA for the treatment of high blood pressure.   "
195122|NCT00403494|"     The purpose of this study is to evaluate whether 6R-BH4 (sapropterin dihydrochloride) is safe     and effective in the treatment of intermittent claudication (IC) caused by peripheral     arterial disease (PAD).   "
195123|NCT00403507|"     The purpose of the study is to determine if participation in an exercise program helps memory     loss from getting worse, and if it improves daily functioning and attitudes of those with     probable Alzheimer's disease. It will involve participation of both the person with memory     loss and someone who knows their daily activities (e.g., husband, wife, adult child, or     caregiver).   "
195124|NCT00403520|"     The purpose of this study is to demonstrate that donepezil slows the progression of     Alzheimer's disease (AD) using magnetic resonance imaging (MRI) of the brain to measure the     volume of the hippocampus in patients with pre-dementia Alzheimer's disease.   "
195125|NCT00403533|"     We hypothesize that atorvastatin will decrease HCV viral load in patients taking the     medication.      Cholesterol is needed for HCV virion production. Cell culture studies have shown that     atorvastatin (an HMG-CoA reductase inhibitor) decreases HCV viral replication. As     atorvastatin has been proven to decrease heart attack and stroke in patients with high     cholesterol, this medication is indicated for the treatment of elevated cholesterol in at     risk individuals. Therefore we propose to study the effect atorvastatin has on the viral load     of patients initiated on atorvastatin therapy for their elevated cholesterol.   "
195126|NCT00403546|"     The primary aims of this study are to assess tolerability of ziprasidone dose escalation to     320 milligrams per day (mg/d) compared to continued standard treatment (placebo) as measured     by the Side Effect Checklist, Simpson Angus Scale for Extrapyramidal Symptoms (SAS), Barnes     Akathisia Scale (BAS), serum prolactin concentrations, vital signs, electrocardiogram (EKG)     and completion rates and to assess whether ziprasidone dose escalation improves overall     psychopathology compared to continued standard treatment as measured by the change from     baseline in the Positive and Negative Syndrome Scale (PANSS) total score and response rates     as defined by a 20% or greater reduction in PANSS total score.      The secondary aims of this study are to assess whether ziprasidone dose escalation improves     psychotic symptoms compared to continued standard treatment as measured by the Positive     Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves     negative symptoms compared to standard treatment as measured by the Negative Symptom Subscale     of the PANSS, to assess whether ziprasidone dose escalation improves depressive symptoms     compared to continued standard treatment as measured by the Calgary Depression Rating Scale     (CDRS), and to assess whether ziprasidone dose escalation improves overall functioning with     the Clinical Global Impression - Severity (CGI-S), Clinical Global Impression - Improvement     (CGI-I), Global Assessment of Functioning (GAF) and the Schizophrenia Cognition Rating Scale     (SCoRS).   "
195131|NCT00403611|"     The primary objective of this project is to evaluate the efficacy and safety of praziquantel     60 mg/kg in the treatment of schistosomiasis, as compared to the standard 40 mg/kg therapy in     a representative community from a highly endemic area of schistosomiasis in Northeastern     Brazil. Cure rates, reduction in egg counts and proportions of reported side-effects in     children at the 10-19 y age-range with at least 100 eggs per gram of faeces will be compared     between regimens, aiming to evaluate the superiority of 60 mg/kg over the 40mg/kg dose     currently recommended by the WHO. Reinfection rates will also be evaluated aiming to improve     transmission control within the local health system, including re-treatment combined with     auxiliary control measures. Features related to the clinical, nutritional and immunological     status of the patients prior to treatment will also be investigated in association with the     outcome of praziquantel treatment.   "
195132|NCT00403624|"     Primary objective:      - To evaluate the rate of responses to neoadjuvant therapy + radiotherapy      Secondary objective:      - tolerability (toxicity) and time to progression   "
195825|NCT00409396|"     The purpose of this study is to determine whether urinary PGE-M levels correlate with     Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with     other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.   "
195133|NCT00403637|"     The study is designed to obtain safety and efficacy data on three dose levels of indacaterol     when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1     day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg,     indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a     washout-period of 1 week   "
195134|NCT00403650|"     This trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension     with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension.   "
195135|NCT00403663|"     Combined spinal - epidural (CSE) anesthesia is a well established technique used for elective     Cesarean section. As its name suggests, it combines two anesthesia techniques - spinal and     epidural. Adjusting the dose of freezing medication for body size is not as simple as giving     a larger dose to a larger person. This study asks a simple, yet important question: does your     body mass index (BMI) influence the amount of freezing medication needed for adequate CSE     anesthesia for Cesarean section? BMI is a number calculated from your height and weight. In     patients with a higher BMI, freezing medication appears to spread farther (to a higher level)     in the spinal fluid. When freezing is too high, it can cause unwanted side effects.     Therefore, in order to provide optimal spinal anesthesia to patients with a higher BMI, it     may be advisable to administer less freezing medication. In this study, we want to find the     ideal dose of freezing medication for patients with a higher body mass index, and compare it     to the dose found to be ideal for patients with normal body mass index.   "
195136|NCT00403676|"     Evaluate the effectiveness and acceptability of care given by nurse specialists in out     patient clinics, through a randomized controlled study.   "
195137|NCT00403689|"     Insoluble (1,3),(1,6)-beta-D-glucan from bakers yeast are indigestible polysaccharides.     Previous studies indicate that the intake of insoluble dietary fiber is strongly associated     with reduced risk of type 2 diabetes and cardiovascular disease. However, the mechanisms     leading to this phenomenon are largely unknown.      There are close relations between metabolic and inflammatory pathways, and a number of     hormones, cytokines, signal proteins, bioactive lipids, and transcription factors have been     shown to be involved in both systems.      Beta-D-glucans have been suggested to play a role as so called biological response modifiers.     Studies in animals indicate that even small doses of (1,3),(1,6)-beta-D-glucan may have     beneficial effects on immune activity, i.e., by reducing the secretion of inflammatory     factors.      The investigators hypothesize that the intake of isolated (1,3), (1,6)-beta-D-glucan from     bakers yeast improves inflammatory makers and insulin-sensitivity in overweight subjects with     increased C-reactive protein concentrations at baseline.   "
195138|NCT00403702|"     The purpose of the study is to compare the safety, intraocular adverse effects and the     anatomic and functional outcome with two endotamponade silicone oil after a 3-month in     complex inferior retinal re-detachments.   "
195139|NCT00403715|"     The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic     Solution with Placebo when applied topically in subjects with dry eye disease.   "
195140|NCT00403728|"     Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of     a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the     mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged     ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at     reperfusion in experimental models. The objective of the present study is to determine     whether administration of CsA at reperfusion in patients with ongoing acute myocardial     infarction treated by coronary angioplasty might reduce infarct size.   "
195141|NCT00403741|"     Assesment the impact of three individuals consultations in adapted physical activity by type     2 diabetics   "
195142|NCT00403754|"     This study was designed to provide data about the safety and efficacy of 3 doses of     indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or     doses, could be chosen for testing in later studies.   "
195143|NCT00403767|"     The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin     for the prevention of blood clots in the brain (referred to as stroke) and blood clots in     other parts of the body referred to as non-central nervous system systemic embolism) in     patients with non-valvular atrial fibrillation (a heart rhythm disorder).   "
195144|NCT00403780|"     The hypothesis behind the trial is the concept that Pregabalin is effective in reducing pain     at rest in lower limb ischemia, and the study evaluates active treatment or placebo added to     the regular pain regimens for these patients.   "
195145|NCT00403793|"     Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a     hormone and hormone injections in order to investigate the suppressive effect on sperm     production and reversibility of sperm production after end of treatment.   "
195146|NCT00403806|"     Adeno-tonsillectomy is a commonly performed surgical procedure in children. Main morbidities     are postoperative pain, nausea and vomiting, and haemorrhage. Non-steroidal anti-inflammatory     drugs (NSAIDs)widely used for paincontrol increase the risk of postoperative bleeding and     reoperation. Dexamethasone is an powerful antiemetic and has shown analgesic efficacy.     Antiemetic and analgesic dose-response has never been established.   "
195148|NCT00403832|"     Cataract is a common complication in uveitis patients. Cataract operations with intraocular     lens implantation are difficult in these patients because of complication due to the     biocompatibility of the intraocular lens. In this study, uveal and capsular biocompatibility     of two widely used acrylate intraocular lenses are compared.   "
195149|NCT00403845|"     The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol     (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD)     so that optimal dose(s) could be chosen for testing in later studies.   "
195150|NCT00403858|"     This was a single centre study comprised of two stages (Parts I and II). Part I was a 9-day     open label evaluation of Movicol administered to patients in hospital. This study evaluated     the safety and efficacy of Movicol in treating faecal impaction. Movicol was administered     over 3 - 7 days to achieve disimpaction.   "
195218|NCT00395187|"     This study will investigate the efficacy of Photodynamic Therapy (PDT), which is the     therapeutic use of photochemical reactions, in treating hidradenitis suppurativa (HS), a     chronic inflammatory condition affecting areas of skin with sweat glands. We expect that PDT     is effective in treating HS.   "
195151|NCT00403871|"     Heart disease among pregnant women is increasing in incidence. The cardiovascular changes     associated with pregnancy may be particularly hazardous for both mother and fetus in a subset     of these patients. The period of greatest risk is peripartum while these patients are under     the care of the obstetrician and anesthesiologist. We will evaluate the anesthetic management     of all women with heart disease whose pregnancies were followed at the University Health     Network and/or Mount Sinai Hospital between 1986 and 2001.   "
195152|NCT00403884|"     In this prospective clinical study SRT is performed with various pulse durations at 1.7µs and     additionally 200ns to evaluate the different clinical effects of both laser regimens. The     macular diseases to be treated are drusen maculopathy and geographic atrophy due to     age-related macular degeneration as well as diabetic macular edema and central serous     chorioretinopathy.      The beneficial effect in laser treatment is thought to be associated with the restoration of     a new barrier of retinal pigment epithelium cells. If this theory is true, the destruction of     the photoreceptors causing visual field defects would be only an unwanted and unnecessary     side effect. Thus, SRT is able to avoid these unintentional side effects and to achieve the     benefit by just treating the RPE.      In this study the clinical effect of SRT for these diseases is evaluated on a long-term     basis.   "
195153|NCT00403897|"     The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment     of chronic constipation in children.   "
195154|NCT00403910|"     The RALES study has shown that spironolactone reduces the risk of morbidity and mortality     both from progressive heart failure and sudden death, in patients with NYHA III or IV heart     failure. This favourable effect was clearly independent from a diuretic effect.     Antialdosterone drugs may be effective because they opposes the effects of aldosterone on     sodium retention, loss of magnesium and potassium, sympathetic activation, baroreceptor     function and vascular compliance. Antialdosterone treatment may also antagonize the effect of     aldosterone in promoting cardiac fibrosis. In a RALES substudy baseline serum PIIINP, a     marker of cardiac fibrosis synthesis showed an independent negative correlation with survival     and CHF hospitalizations in the placebo group. Therefore it seems interesting to evaluate the     effect of an Aldosterone receptor blocker on progression of left ventricular dysfunction in     patients with mild heart failure assuming standard therapy.   "
195155|NCT00403923|"     The hypothesis underlying this study is that failure to recognise the role of lactose     intolerance among patients with ulcerative colitis has led to inappropriate dietary advice     and treatment with drugs that contain lactose as a filler. These failures exacerbate symptoms     and lead to the unnecessary use of immune suppressant drugs.      There is disagreement amongst researchers regarding the amount of lactose needed to cause     symptoms in those who are lactose intolerance. The general consensus is that the amount of     lactose in a glass of milk (12 grams) is enough to cause mild symptoms in most patients who     are lactose intolerant (1). However, there have been a number of studies and case studies     that argue that much lower amounts can cause symptoms (2, 3, 4, 5). This could be as little     as 0.02 grams (6).      Ulcerative colitis is a chronic relapsing inflammatory disease of the colon and rectum,     characterised by recurrent episodes of abdominal pain and profuse diarrhoea. The prevalence     of lactose intolerance in patients with ulcerative colitis is not greater than in the general     population, but there is no evidence as to whether these patients are more sensitive to     lactose.      This study will identify the threshold at which symptoms of lactose intolerance develop in     those who have both lactose intolerance and ulcerative colitis, to provide appropriate advice     and treatment in the management of patients with these conditions.   "
195156|NCT00403936|"     This study was designed to determine whether a simple manipulative technique of relaxing the     tissues of the occipito-atlantal junction in the neck had any effect on the activity of the     sympathetic or parasympathetic nervous system. Subjects were dark adapted then measures of     pupillary activity, reflecting autonomic nervous system activity were taken before and after     treatment. The study hypothesis was that thet treatment technique would have no effect on the     pupillary measures, hence indicating no effect on autonomic system activity.   "
195157|NCT00403949|"     The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment     of mild to moderate perioral dermatitis.   "
195158|NCT00403962|"     The purpose of this study is to assess the efficacy, safety and tolerability of a combination     of Vestipitant and Paroxetine in patients with Social Anxiety Disorder (SAD)   "
195159|NCT00403975|"     The purpose of this trial is to assess the effectiveness and safety of 2% diquafosol     tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects     with mild to moderate dry eye disease.   "
195160|NCT00403988|"     Study Objective :      To assess the efficacy and the safety of the combination of Oxaliplatin, and Vinorelbine with     or without Trastuzumab as a salvage regimen in patients with Metastatic Breast Cancer   "
195161|NCT00404001|"     The primary objectives of this study are to evaluate the safety of MD-0727 in patients with     primary hypercholesterolemia and to determine the low density lipoprotein cholesterol (LDL-C)     lowering effect and dose-response of MD-0727 in patients with primary hypercholesterolemia.   "
195162|NCT00404014|"     The primary objective is to compare mild cognitive impairment in the AL-208 group with the     placebo group at 14 + - 3 days after CABG surgery   "
195632|NCT00400348|"     The purpose of this study is to evaluate the efficacy, limited pharmacokinetics (PK), and     safety of 1,000 mg of Panzem® NCD administered orally four times a day to patients with     recurrent or resistant epithelial ovarian cancer.   "
195163|NCT00404027|"     The purpose of this research study is to assess patient and provider attitudes towards the     role that patients should play in medical decision making and self-management. We will     examine the degree to which similarity of attitudes held by VA patients being treated for     co-morbid diabetes mellitus and hypertension and by their primary care providers is a     determinant of patient satisfaction, patient adherence, and adequacy of blood pressure and     diabetic control.   "
195164|NCT00404040|"     This was a single centre study comprised of two stages (Parts I and II). Part II was a 12     week randomised double blind comparison of Movicol and Lactulose Dry as maintenance therapy     on an out-patient basis. The aim was to evaluate the safety and efficacy of Movicol in the     treatment of faecal impaction in children   "
195165|NCT00404053|"     In view of its safety profile and the results of clinical trials, clopidogrel has become the     standard treatment for patients with acute coronary syndrome (ACS) and drug eluting     stent(DES) implantation. Two large studies in patients with ACS shown that pretreatment with     clopidogrel had beneficial effects. The pretreatment regimens were given a mean of 6 days     before intervention in the observational PCI-CURE trial and 3 to 24 h in the randomized CREDO     trial respectively. Accordingly, current clinical practice carries out pretreatment with a     300mg loading dose of clopidogrel at least 6 h before DES implantation procedure in patients     with ACS. Compared with the 300mg clopidogrel loading dose, 600mg loading dose exhibited a     superior antiplatelet effect and improved short-term clinical outcomes in patients undergoing     DES implantation for ACS according to recent a few publications. But despite clopidogrel     600mg loading dose and the routine use of 75mg per day as a maintaining dose, recurrent     ischemic events occurred in some patients. Therefore, the goal of this study will evaluate     the efficacy of a 600mg loading dose of clopidogrel plus 150mg per day as a maintaining dose     in patients with ACS undergoing DES implantation.      ACS patients undergoing DES implantation who receive planned 600mg loading dose clopidogrel     pretreatment are eligible for the study. All enrolled patients will be randomized to receive     daily clopidogrel 75 mg or 150mg as maintaining doses starting as soon as post-PCI, in     addition to daily aspirin 100 mg, and lasted for the first month after DES implantation. One     month later, all patients receive daily clopidogrel 75mg until 9~12month after DES     implantation. The primary endpoints include death of all causes, myocardial infarction,     revascularization of the target lesson, sub-acute and late stent thrombosis one year after     PCI, The secondary endpoints are major and minor bleeding events. The study will be powered     to test the hypothesis that higher maintaining dose(150mg) of clopidogrel will reduce major     adverse cardiac events compared to currently used common dose(75 mg) at one year following     PCI.   "
195166|NCT00404066|"     This trial combines dose dense chemotherapy with Doxorubicin and Cyclophosphamide (AC)     followed by standard every 3 week docetaxel and GW572016 for neoadjuvant treatment of her2neu     positive stage II/III breast cancer. GW572016 or Lapatinib, the investigational agent, acts     as a duel inhibitor of both epidermal growth factor receptor (EGFR) and ErbB-2 (Her2/neu)     tyrosine kinase activity. EGFR and ErbB2 receptors are frequently over-expressed or altered     in human cancers including breast cancer. This study plans to determine the antitumor     activity of this regimen and its effectiveness of preventing tumor growth and spread.   "
195167|NCT00404079|"     Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and     degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability.     Some indications exist for symptomatic and possible cartilage-structurmodifying effect on     knee- and hip-osteoarthritis with glucosamine sulphate (GS). The OA process in the lumbar     spine is most likely to OA processes in knees and hips, hence GS could have comparable     symptomatic and structural effect on lumbar OA.      Study hypothesis: No difference in treatment effect exists between oral intake of GS- or     placebo-capsules for patients` with chronic low back pain measured with Roland Morris     Disability Questionnaire.   "
195168|NCT00404092|"     This study investigates the safety and tolerability as well as the efficacy and     pharmacokinetics of caspofungin in four escalating dosages in adult patients with hematologic     malignancies and proven or probable invasive aspergillosis.   "
195169|NCT00404105|"     The study compares the precision and accuracy of two laser refractive techniques, PRK and     LASIK, for correction of nearsightedness between -6 and -8 diopters.   "
195170|NCT00404118|"     Long-term care (LTC) can be defined as the range of institutional and home and     community-based services that support individuals needing chronic care. The defining values     of LTC in the VA include caring for patients in the least restrictive environment consistent     with meeting a patient's needs. VA faces an increasing demand for these services with the     growing number of veterans 85 years and older, those most in need of LTC. Yet in fiscal year     2007, 87% of the 3.5 billion total VA dollars spent on LTC went to institutional care rather     than the less restrictive Home and Community Based Services (HCBS). VA Central Office has     formally committed to tripling the proportion of LTC that is HCBS between 1999 and 2011.      Study Objectives: (1) Develop and test measures of patient/caregiver and provider     satisfaction. (2) Develop and test measures of process and cost of the LTC referrals.      Methods: Three VAMCs in VISN 11 are the study setting. This study was conducted from October     2007-June 2010 and utilized a variety of data sources throughout this timeframe. Data sources     included: the Geriatric Extended Care form, telephone and in-person interviews, online and     paper surveys, Extended Care Screening Committee meeting minutes, and technical reports from     the Health Economics Resource Center.      Status: Complete.   "
195171|NCT00404131|"     The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic     Solution with placebo when applied topically in subjects with dry eye disease.   "
195172|NCT00404144|"     The objective of this study is to assess the safety and efficacy of the Paclitaxel-eluting     PTCA-balloon catheter (3µg/mm2 balloon surface area) in the treatment of significant (≥ 70%     and < 100 %) stenoses in native coronary arteries with reference diameters from 2.25 mm to     2.8 mm and ≤ 22 mm in length for procedural success and preservation of vessel patency.   "
195173|NCT00404157|"     This is a Phase III, multicenter, extension study to evaluate the safety of rituximab     administered on a scheduled basis approximately every 6 months. All subjects who complete     their Week 52 visit in Study U2970g will be eligible for this study, as long as the inclusion     and exclusion criteria are met.   "
195174|NCT00404170|"     The purpose of this study is to investigate the utility of dopamine transporter imaging in     monitoring and predicting the progression of Parkinson disease. This study will be performed     in the PRECEPT cohort, an already existing cohort of 806 subjects recruited to participate in     the study called, A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to     Assess the Efficacy and Safety of CEP-1347 in Patients With Early Parkinson's Disease -     (PRECEPT), sponsored by Cephalon and Lundbeck and coordinated by the Parkinson Study Group.     The imaging data from this long-term PRECEPT follow-up study will allow us to evaluate the     long-term progression of DAT loss in PD, the long-term follow-up of SWEDD subjects, the     relationship between long-term clinical and imaging PD outcomes, and the relationship between     long-term imaging outcomes and genetic and biochemical biomarkers of PD progression.   "
195177|NCT00404209|"     To investigate the feasibility and advantages of using pressurized perfluorocarbon liquid     (PCL) perfusion to remove vitreous during suction-cutting 23 GA vitrectomy using a dual,     dynamic drive (3D)technology, in complicated retinal detachment surgeries.   "
195178|NCT00404222|"     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety     of the administration of Extended Release Hydrocodone/Acetaminophen and Immediate Release     Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had     a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged     from the hospital.   "
195826|NCT00409409|"     A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens     compared with placebo for reduction of symptoms and rescue medication usage in children.   "
195179|NCT00404235|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin     together with ABI-007 works in treating patients with stage IV melanoma that cannot be     removed by surgery.   "
195180|NCT00404248|"     RATIONALE: Drugs used in chemotherapy, such as tetra-O-methyl nordihydroguaiaretic acid     (EM-1421), work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.      PURPOSE: This phase I/II trial is studying the side effects and best dose of EM-1421 and to     see how well it works in treating patients with recurrent high-grade glioma.   "
195181|NCT00404261|"     The purpose of this study is to evaluate the level of satisfaction experienced by asthma or     chronic obstructive pulmonary disease (COPD) patients when using the Fluticasone/Salmeterol     HFA Metered Dose Inhaler (MDI) with counter, as compared to using Fluticasone/Salmeterol HFA     MDI without counter.   "
195182|NCT00404274|"     GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test     the extent of the GW679769 affect on Warfarin levels in humans.   "
195183|NCT00404287|"     Atherosclerosis and aortic stenosis share inflammatory etiopathogenic characteristics in     common. We hypothesized that statins therapy would decrease inflammatory markers     concentrations in patients with degenerative aortic stenosis and halt the haemodynamic     progression of the disease.   "
195184|NCT00404300|"     An open, multi-centre study in patients with von Willebrand Disease (VWD) undergoing surgery.   "
195185|NCT00404313|"     A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic     asthma.   "
195186|NCT00404326|"     The current standard for locally advanced cervical cancer is concurrent cisplatin-based     chemotherapy, however, the treatment results need to be improved. Epigenetic aberrations play     an important role in cancer progression by silencing growth regulatory genes and there is now     evidence that inhibitors of DNA methylation and HDAC inhibition synergize the radiation and     chemotherapy effects.      Objective. To determine response rate, safety and biological effects of hydralazine and     magnesium valproate when added to cisplatin chemoradiation.      Hypothesis. Hydralazine and magnesium valproate associated to chemoradiation will increase     the clinical complete response rate to 95% as compared to 75% as seen in historical controls     treated with cisplatin chemoradiation in FIGO stage IIIB patients.      Metodology. A total of 17 FIGO stage IIIB patients with histologically confirmed cervical     carcinoma with no previous treatment will be included. Patients will be typed for acetylator     status and and then receive either 182 or 83 mg of hydralazine, and magnesium valproate at     40mg/Kg from day -7 to the end of chemoradiation (external and brachytherapy). Clinical     response rate, safety and transcriptome changes will be analyzed.   "
195187|NCT00404339|"     RATIONALE: Vaccines made from a person's dendritic cells mixed with peptides may help the     body build an effective immune response to kill tumor cells.      PURPOSE: This randomized phase I trial is studying the side effects of vaccine therapy in     treating patients with head and neck cancer.   "
195188|NCT00404352|"     The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical     trial with an optional 12 months open label extension.      The primary objective of the study is to evaluate the effect of fetal bovine serum     [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN] beta-1a (RNF) 44     microgram (three times weekly and once weekly) versus placebo on the time to conversion to     McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical     demyelinating event at high risk of converting to MS.      The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three     times weekly and once weekly) versus placebo on the Time to conversion to clinically     definite MS (CDMS) in subjects with a first clinical demyelinating event at high risk of     converting to MS.      At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS     and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month     extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the     time to conversion to McDonald MS and time to conversion to CDMS.   "
195189|NCT00404365|"     RATIONALE: Screening tests may help doctors find depression in patients with lung cancer,     allow doctors to recommend treatment for depression, and improve the patient's quality of     life.      PURPOSE: This randomized clinical trial is studying how well depression screening works when     the results are or are not shared with patients with lung cancer and their doctor.   "
195190|NCT00404378|"     This is a two period study of healthy adult subjects to characterize the effect of the dosing     of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the     safety profile of oral casopitant with and without ketoconazole. This study will consist of a     screening period, two treatment periods and a post-treatment follow-up visit.   "
195191|NCT00404391|"     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety     of the administration of 2 different dose levels of Extended Release     Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had     bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are     discharged from the hospital.   "
195203|NCT00394992|"     The primary aim of this study is to investigate whether the addition of the new anti-cancer     drug bevacizumab (Avastin) to the combination of the chemotherapeutic agents capecitabine     (Xeloda) and oxaliplatin (Eloxatin) reduces (slows down) the recurrence of metastatic disease     after a radical resection of liver metastases in patients with colorectal cancer.   "
195192|NCT00404404|"     RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     find tumor cells and kill them or carry tumor-killing substances to them. Others interfere     with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of     tumor cells by blocking blood flow to the tumor. Giving ABI-007 together with bevacizumab may     kill more tumor cells.      PURPOSE: This phase II is studying how well giving ABI-007 together with bevacizumab works in     treating women with recurrent or metastatic breast cancer.   "
195193|NCT00404417|"     This study will assess the efficacy and the duration of efficacy of Botulinum toxin A     (Botox®) injected into the lumbar paraspinal muscles for reducing pain and disability in     subjects suffering from chronic low back pain of six months duration or longer and arising     from an identifiable muscle strain injury or back trauma. The treatment modality and     techniques used are based on a successful prior 4 month open-labeled pilot study done by this     research group, but will employ a prospective double-blind, randomized, cross-over design to     control for any placebo or mechanical trigger-point injection effects. Subjects will also be     assessed for a longer duration to better define the duration of efficacy.   "
195194|NCT00404430|"     The main objective of the study is to evaluate the predictive factors of the endothelial     function to the waning of an acute exacerbation in COPD. It will act to do a multivariate     analysis to determine the respective weight of the parameters of the systemic inflammation,     of the oxidative stress of the functional respiratory parameters and then functional     respiratory parameters.      In exacerbated Chronic Obstructive Pulmonary Disease (COPD) patients, there is augmentation     of hypoxia and the obstructive ventilatory disorders is more important. This is correlated     with an increase in C-reactive Protein (CRP) and of inflammatory cytokines and oxidative     stress. It has been demonstrated that there is an endothelial dysfunction in answer to     hypoxia. Since the exacerbated COPD patients are hypoxic in most cases , we suppose they have     an endothelial dysfunction during exacerbation. So we think we will find an augmentation of     vascular resistances ,shown by a peripheral arterial tone too high. And this, certainly, play     a part in physiopathology of the COPD exacerbation.   "
195195|NCT00404443|"     To study the efficacy of acupuncture used as an adjunct measure for patients with refractory     RA   "
195196|NCT00394524|"     High blood sugars increase the risk of complications and death in diabetic patients admitted     to the hospital. Recent studies hve shown that strict blood sugar control with intravenous     (IV) insulin lowers the risk of such complications and death in the ICU. Several insulin     infusion protocols have been reported in the literature, but it is not known which is the     best. These protocols use tables and formulas that may be confusing and difficult to follow.     To facilitate patient care, insulin protocols could be placed on a computer and used at the     patient's bedside to direct the nursing staff administering the IV insulin. The Glucommander     is one of such computer-derived insulin infusion protocol which has been used successfully in     patients with diabetes since 1984. We hypothesize that management of inpatient hyperglycemia     with a computer-guided intravenous infusion protocol will facilitate smoother glycemic     control with a lower rate of low blood sugars than treatment following a standard insulin     infusion algorithm in the medical intensive care unit. We will aim to determine differences     in glycemic control between treatment with a computer-guided intravenous infusion protocol     (Glucommander) and a standard insulin infusion algorithm in critically ill patients in the     ICU.   "
195197|NCT00394537|"     Passing a bronchoscope through the airways frequently causes a stress response even though     patients are sedated. This stress response is usually an increase in pulse and blood     pressure, which may have undesirable effects on the heart and circulation.      We plan to give patients labetalol (a beta blocker which reduces pulse and blood pressure) in     addition to normal sedation, to patients undergoing bronchoscopy in our department.   "
195198|NCT00394914|"     This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the     efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms     in asthmatic participants exposed to picornavirus respiratory infections. Participants will     be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses).     Participants will be followed for an additional 14 days.   "
195199|NCT00394927|"     The purpose of the survey is to explore through a structured interview and patient     examination the rate and distribution of neurological and systemic adverse effects related to     antiepileptic treatment. Adverse effects and considerations to modify the therapy will be     assessed in pediatric and adult patients with controlled as well as uncontrolled epilepsy     with different seizure types   "
195200|NCT00394940|"     Chronic obstructive pulmonary disease (COPD) is a condition that is characterized by airway     obstruction due to inflammation. Levels of inflammatory proteins may be linked to when and to     what extent COPD develops. This study will use data collected during the Tucson     Epidemiological Study of Airway Obstructive Disease (TESAOD) and its 33-year follow-up to     determine the relationship between inflammatory protein expression and COPD.   "
195201|NCT00394953|"     This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa,     administered at extended dosing intervals, in the maintenance treatment of anemia in patients     with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving     once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to     receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360     micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study)     or intravenous darbepoetin alfa every 2 weeks before switching to once monthly     administration. The anticipated time on study treatment is 3-12 months, and the target sample     size is 100-500 individuals.   "
195202|NCT00394966|"     This is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled     study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy.     Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before     initiation of chemotherapy on Day 1. Subjects will record nausea and vomiting in the SPNV     Subject Diary through Day 6. The quality of life assessment as measured by the Functional     Living Index-Emesis Questionnaire (FLIE) will be used to measure the effect of     chemotherapy-induced nausea and vomiting (CINV) on daily life. Blood samples for SCH 619734     pharmacokinetic assessments will be collected. The study is to be conducted in conformance     with Good Clinical Practice.   "
195219|NCT00395200|"     Hypothesis: Intravenous administration of bone marrow-derived autologous adult human     mesenchymal stem cells is a safe novel therapeutic approach for patients with multiple     sclerosis.      Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) is a phase I/IIA trial designed to     establish the safety of intravenous administration of bone marrow-derived autologous adult     human mesenchymal stem cells to patients with multiple sclerosis.   "
195827|NCT00409422|"     To compare anthropometric and metabolic effects of a comprehensive weight management program     on obese adolescents and children in comparison to regular clinical weight management visits.   "
195204|NCT00395005|"     Urinary kallikrein excretion is known to increase in patients with nephrotic syndrome and     sick cell disease, but decrease in patients with chronic kidney disease or uremia. Some of     authors consider urinary kallikrein is a marker of nephropathy. To evaluate the possible role     of kallikrein kinin system in chronic kidney disease, we conduct a retrospective longitudinal     observation study. Patients who participating in the “Efficacy of Pentoxifylline on Chronic     Kidney Disease” study are included in the study. The morning spot urinary kallikrein and     cytokines are measured at the time point of 0 and 12 month in addition to clinical     parameters. The correlation of urinary kallikrein and cytokine concentration will be     evaluated. Using multiple regression model, the relationship of urinary kallikrein excretion     with degree of proteinuria, creatinine clearance and other clinical parameter will also be     evaluated.   "
195205|NCT00395018|"     The purpose of this clinical research study is to learn if the study drug entecavir will     prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic     liver transplant (OLT) due to HBV infection.   "
195206|NCT00395031|"     The aim of the protocol is to study the effects of 320 mg/day of ziprasidone (Geodon) on     glucose and lipid metabolism of patients with both Diabetes Type II (DM) and schizophrenia or     schizoaffective disorder, after switching their antipsychotic medication/s from typical     and/or atypical to ziprasidone monotherapy.   "
195207|NCT00395044|"     This is a study to evaluate the efficacy of the medication gabapentin in treating persons     with cannabis dependence.   "
195208|NCT00395057|"     This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as     Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related     macular degeneration   "
195209|NCT00395070|"     To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide     (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.   "
195210|NCT00395083|"     EXECUTIVE SUMMARY:      Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention     incorporating self-management education, an action plan, and case-management to decrease the     risk of hospitalizations due to chronic obstructive pulmonary disease (COPD) among veterans     with severe COPD.      Hypotheses:      Primary Hypothesis:      Veterans with COPD who receive a self-management program incorporating education sessions,     development of an action plan, and case-management will have a decreased risk of COPD     hospitalization compared to standardized COPD care.      Primary Objective:      In an intent-to-treat analysis, determine the efficacy of a comprehensive self-management     program for reducing the risk of COPD hospitalization in veterans with severe COPD in     comparison to patients receiving standardized COPD care.      Secondary Hypotheses:      Compared with standardized COPD care, veterans with COPD who receive a comprehensive     self-management intervention will have: A) decreased health-related costs resulting from     decreased hospitalizations and outpatient utilization, B) decreased hospitalization rates and     average length of stay due to both COPD and all-cause admissions, and C) improvement in a set     of outcomes including mortality, health-related quality of life, medication adherence,     patient satisfaction, disease knowledge, skill acquisition and self-efficacy.      Secondary Objectives:      To evaluate the healthcare costs, hospitalization days, mortality, adherence, and health     outcomes of a comprehensive self-management program compared to standardized COPD care among     patients with severe COPD measured by:      A)Healthcare-related costs B)Health services use due to COPD and to all causes C)Clinical     outcome measures        1. Mortality        2. Health-related quality of life measured by generic and COPD-specific measures        3. Patient satisfaction        4. Medication adherence        5. Disease knowledge, skill acquisition and self-efficacy      In the proposed study, 960 veterans with severe COPD hospitalized in the previous year will     be randomly assigned to either a comprehensive case management program or standardized COPD     care. The comprehensive group will receive an initial, intense education program with     development of an action plan, and regular telephone contacts by a case manager in addition     to standardized COPD care. Patients allocated to the control arm will receive standardized     care that incorporates guideline-based recommendations including influenza vaccination, a     short-acting bronchodilator, and either a long-acting bronchodilator or inhaled     corticosteroid inhaler.      The study will be conducted in 2 phases, a 12-month feasibility study conducted at 6 VA sites     followed by the full study in which an additional 8 sites will enroll patients over the next     24 months. As a result, 180 patients will be initially enrolled in the feasibility study over     the first year and the remaining 780 patients will be enrolled in the second and third years     of the study when the full study is implemented. Subjects will be followed until the     completion of the study, for at least one, and up to four years. The primary outcome is time     to first COPD hospitalization.   "
195211|NCT00395096|"     Asthma is one of the most common childhood diseases. It is chronic and often severely     disabling. The amount of nitric oxide that is exhaled while breathing increases with airway     inflammation, a symptom of asthma. This study will examine the results from a previous study,     the Cincinnati Asthma Prevention (CAP) study, to evaluate the effects of environmental and     genetic factors on exhaled nitric oxide (eNO) levels and to determine the relationship     between eNO and asthma severity.   "
195212|NCT00395109|"     Patients with head and neck cancer will be imaged with PET scan and CT scan in order to     determine areas of the tumour that are hypoxic.      It is hypothesized that PET /CT will provide information on hypoxia of the tumors and tumor     regions in head and neck cancer patients.   "
195213|NCT00395122|"     The study is designed to evaluate the ability of optical coherence tomography and VCC     scanning laser polarimetry to measure and identify the pattern of band atrophy of the optic     nerve in patients with long standing chiasmal lesions. The hypothesis is that these new     technologies are able to identify such pattern. The idea is that by using eyes with band     atrophy one is able to investigate the ability of the new technologies in measuring the     retinal nerve fiber layer particularly in the nasal and temporal portions of the optic nerve.   "
195214|NCT00395135|"     The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the     first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight     loss at the end of the second year of treatment (Week 104)   "
195215|NCT00395148|"     High levels of good cholesterol (HDL) in our blood decreases our chance of having a heart     attack. This relates in part to the role good cholesterol plays in reducing build up of fat     in the arteries. However, good cholesterol has many other protective effects. We have     recently identified three enzymes (proteins) activated by HDL in cells lining the blood     vessels, which may be responsible for some of HDL's protective actions.   "
195216|NCT00395161|"     Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial     infection and sepsis remain the leading acquired causes of morbidity and mortality in     critically ill children. Subsequent use of antibiotics to treat nosocomial infection and     sepsis is considered a major attributable factor in the rise of antibiotic-resistant     organisms in this population of children. This study will use a double-blind, randomized,     controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide,     zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill     children.   "
195217|NCT00395174|"     The purpose of this study were to obtain additional evidence in support of the safety and     immunogenicity of a recombinant hemagglutinin (rHA) vaccine in an elderly population, and to     establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a     licensed trivalent influenza vaccine (TIV). Another purpose was to provide a preliminary     estimate of the relative efficacy of the two vaccines against culture-positive influenza-like     illness during the subsequent epidemic.   "
195221|NCT00395226|"     Rosacea is a common chronic dermatological condition, characterized by recurrent or     persistent redness, permanent dilation of small blood vessel causing small red lesions, and     papules/pustules. The signs of rosacea are usually confined to the face, but may appear on     the neck, scalp or trunk. Opthalmologic findings are also common. Rosacea is usually     described as being most common in fair skinned women over 40. The purpose of the study is to     determine whether oral Zinc Sulfate treatment is an effective treatment for facial rosacea.   "
195222|NCT00395239|"     The investigators propose to study the patterns of metabolite changes in subjects with asthma     to determine if there is a predictable pattern prior to, and post, clinical exacerbation.      Hypothesis: 1. Metabolite profiles will change prior to detection of a clinical exacerbation     in subjects with asthma.      2. There will be a measurable temporal delay before metabolite profiles return to baseline     following anti-inflammatory therapy of an exacerbation of asthma.   "
195223|NCT00395252|"     This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in     patients with R0 OR R1-resected pancreatic cancer.   "
195224|NCT00395265|"     Venous thrombosis is the development of a blood clot in a vein. Post-thrombotic syndrome     (PTS) is a painful condition that can develop following a venous thrombosis in one of the     deep veins of the leg. While PTS is mainly thought to occur because of damage to the vein,     other factors may be responsible for the development of this condition. This study will     analyze genetic and biologic samples from participants of a previous study to examine other     possible causes of venous diseases and PTS.   "
195225|NCT00395278|"     Dr. Burbelo and colleagues have developed a technique for rapidly and quantitatively     detecting antibody responses in sera to a variety of pathogens using recombinant proteins. We     would like to apply this technique to develop an assay for detecting antibodies to HHV-8     (KSHV, the etiologic agents of Kaposi's sarcoma, an AIDS-defining condition). We initially     plan to examine samples from patients with Kaposi's sarcoma, since all those patients are     almost certainly infected with HHV-8. We are thus using samples from patients with previously     diagnosed Kaposi's sarcoma. The samples in question are stored at the NCI FCRF repository     operated by SAIC Frederick or in Rockville, MD.   "
195226|NCT00395291|"     The objective of this study is to determine MK-0677 increases IGF-1 in patients with end     stage renal disease (ESRD) on hemodialysis.   "
195227|NCT00395304|"     Asthma is a common, serious illness among children in the United States. While a low dose of     inhaled corticosteroids (ICS) may effectively control symptoms, some children may require     additional medications to maintain adequate asthma control. This study compares the     effectiveness of a higher dose of ICS, ICS combined with a long-acting beta-agonist (LABA)     medication, and ICS combined with a leukotriene receptor antagonist (LTRA) medication at     reducing the impact and severity of asthma exacerbations that occur in children with mild to     moderate persistent asthma.   "
195228|NCT00395317|"     SB-683699 is an oral medication that is thought to reduce the number of active white blood     cells entering the brain; these white blood cells are part of the disease process for MS.     This study will look at whether different doses of SB-683699 are effective and safe in     patients with relapsing remitting MS.   "
195229|NCT00395330|"     In the weeks following the terrorist attacks of September 11, 2001, many patients presented     to their physicians with complaints related to exposure to the debris. These included nose     and throat complaints (drip, congestion, sore throat), increased GE reflux (heartburn,     regurgitation, retrosternal chest burning) and respiratory symptoms (worsening cough,     wheezing, shortness of breath, chest tightness, sleep disturbance). In addition, there was a     disproportionate rate of self-reported worsening asthma symptoms in patients living in Lower     New York 5-9 weeks after the attack; those with exposure to the dust cloud fared worse. The     functional abnormalities of firefighters with exposures to dust at the WTC site has been     recently described. However, the effects of WTC dust exposure on pulmonary function in     residents and workers near the WTC site remain unclear. This study will retrospectively     review the charts of all patients referred to the pulmonary function laboratory for     evaluation of symptoms following exposure to WTC dust. The main objectives for this study     will be to characterize the functional abnormalities in these subjects.   "
195230|NCT00395343|"     A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2     Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin     combination therapy.   "
195231|NCT00395356|"     The goal of the study is to measure the effect of an approach including phases of active     weight loss broken by weight stabilisation periods (named intermittent weight loss) on the     metabolic profile.      First, the intermittent weight loss approach will contribute to create an artificial     transitory steady state during the weight loss treatment that will help to minimize the     adverse effects of the standard approach on muscle mass and resting metabolic rate. Second,     despite a comparable fat mass loss, the intermittent weight loss approach will improve the     metabolic profile to a greater degree compared to the standard approach. Finally, the     intermittent weight loss approach will be associated with less weight regain after the     treatment since the beneficial effect on muscle mass and metabolic rate.   "
195247|NCT00395577|"     The purpose of this study is to assess the safety and effects of VX-702 in subjects with     moderate to severe rheumatoid arthritis and who are taking the drug methotrexate.   "
195232|NCT00395369|"     Cognitive and neurological dysfunction after coronary artery bypass surgery (CABG) is common     and multi-factorial in origin. Several previous studies have shown that intraoperative     aprotinin administration may be neuroprotective.in the current prospective randomized study,     the effect of intraoperative aprotinin administration on the integrity of the optic nerve and     retinal nerve fiber layer will be examined. Optical coherance tomography will be used to     examin the optic nerve and retinal nerve fiber layer.   "
195248|NCT00395590|"     Obstructive sleep apnea is a common sleep disorder. It is known to be related with increased     body mass, abdominal obesity, insulin resistance and hypertension. It is currently believed     to be a feature of the metabolic syndrome. Other features of the metabolic syndrome-such as     insulin resistace were found related to inflammation and inflammatory cytokines. Several     polymorphisms in the genes that encode interleukin 6,inteleukin 10 and TNF-alpha have     significant influence on the amounts of cytokine production. we thus hypothesize that     polymorphisms related to increased pruduction are more common in subjects with OSA than in     matched controls   "
195233|NCT00395382|"     Cardiovascular disease (CVD) is the commonest cause of mortality in patients with chronic     kidney disease (CKD) and end-stage kidney disease (ESKD). Reasons for the greater incidence     of CVD in this group include traditional CVD risk factors of hypertension, dyslipidemia and     diabetes but more importantly also include non-traditional risk factors such as calcium and     phosphate imbalance. The latter is thought most likely to contribute to vascular     calcification, especially for those on dialysis, and this in turn leads to arterial stiffness     and left ventricular hypertrophy, the two commonest cardiovascular complications. Arterial     stiffness and calcification have been found to be independent predictors of all-cause and     cardiovascular mortality in CKD. Few studies, though, have looked at both structural and     functional changes associated with calcification and there have been very few interventional     studies addressing this issue.      Control of calcium and phosphate levels in CKD can occur with the use of medications that     reduce elevated serum phosphate (phosphate binders, mostly calcium-based) and those to treat     hyperparathyroidism (vitamin D and more recently calcium sensing receptor agonists called     calcimimetics). These pharmacological managements addressing calcium and phosphate imbalance     reduce vascular calcification and CVD. Bisphosphonate therapy may also have a role in     reduction of calcification.      Low bone mineral density (BMD) is common in CKD patients and predicts increased fracture risk     similar to the general population. Bisphosphonate therapy improves BMD and lowers the     fracture risk. Bisphosphonates may also have a role in secondary hyperparathyroidism to     reduce hypercalcemia and allow for more aggressive calcitriol treatment. Recent studies have     addressed the possibility of bisphosphonates reducing the progression of vascular     calcification in CKD and revealed that the extent of calcification may be suppressed in     association with a reduction in chronic inflammatory responses.      The investigators aim to perform a prospective, randomised study assessing the impact of     alendronate on cardiovascular and bone mineral parameters. This will be a single-centre study     involving subjects with CKD Stage 3 (those patients with GFR between 30 and 59ml/min).     Arterial stiffness (by pulse wave analysis and pulse wave velocity) and vascular     calcification (using CT scans through superficial femoral artery) will be followed as well as     serum markers of calcium, phosphate and PTH. Differences in these end-points will be compared     between participants taking alendronate and those not. The study will be conducted over a 12     month period and the investigators aim to recruit about 50 patients (25 on alendronate and 25     control).   "
195234|NCT00395395|"     This is a phase I study to analyze the effect of water and food intake on the bioavailability     and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in     post-menopausal women.   "
195235|NCT00395408|"     The purpose of this study is to compare the effect of montelukast with placebo and     beclomethasone on the average rate of linear growth over a period of 56 weeks in children     with mild asthma.   "
195236|NCT00395421|"     This study is being conducted to see if the investigational medication, valopicitabine, is     safe to use in combination with ribavirin, a drug approved by the FDA for treating hepatitis     C infection.   "
195237|NCT00395434|"     The purpose of this study is to determine the safety and tolerability of three dose levels of     combretastatin A4 phosphate (CA4P) given intravenously (IV) in combination with bevacizumab     every 14 days in patients with advanced solid tumors. The maximum tolerated dose will be     defined if it is at one of the three dose levels under study.   "
195238|NCT00395447|"     The objective of this study is to prospectively estimate the all-cause complication rates at     6-months for patients undergoing generator replacement due to elective replacement indicator     (ERI), advisory, or upgrade without a planned system modification or with a planned system     modification. Secondarily, this study aims to compare the influence of baseline variables     contributing to the all-cause complication rates for subjects undergoing generator     replacement.   "
195239|NCT00395460|"     The purpose of this study is to determine if the contrast agent is effective and safe in the     Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.   "
195240|NCT00395473|"     In the context of australian general practice, to determine the efficacy and safety of     ezetimibe 10mg/statin 40mg coadministration in patients with uncontrolled cholesterol     receiving statin 40mg or more.   "
195241|NCT00395486|"     The primary objective of this study is to compare the effect of rosuvastatin 10mg with     atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with     metabolic syndrome.   "
195242|NCT00395499|"     The purpose of this research is to: (1) examine the secrection of risperidone (RIS)     (Risperdal) and its metabolite, 9-OH-RIS, in saliva, (2) determine the concentration ratio of     RIS and 9-OH-RIS between plasma and saliva, and (3) compare the rate of decline in     concentration of RIS and 9-OH-RIS in saliva and plasma by measurements at timed intervals     during a single dosing interval.   "
195243|NCT00395512|"     The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and     pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with     diet and exercise alone.   "
195244|NCT00395538|"     Hypoparathyroidism is a rare condition associated with a low level of parathyroid hormone     (PTH) in the blood. Hypoparathyroidism can be genetic and show up in childhood, or it can     occur later in life. If it occurs later, it is usually due to damage or removal of the     parathyroid glands during neck surgery. PTH helps control the amount of calcium in blood,     kidneys, and bones. Low levels of calcium in the blood can cause a person to feel sick. It     can cause cramping or tingling in the hands, feet, or other parts of the body. A very low     blood calcium can cause fainting or seizures.      The standard treatment for hypoparathyroidism is a form of vitamin D (calcitriol) and calcium     supplements. Keeping normal blood levels of calcium can be difficult. Sometimes there is too     much calcium in the urine even if the calcium levels in the blood are low. High calcium in     the kidneys and urine can cause problems such as calcium deposits in the kidney     (nephrocalcinosis) or kidney stones. High levels of calcium in the kidney may keep the kidney     from functioning normally. Treatment with PTH will replace the hormone you are missing. Your     disease may be better controlled on PTH than on calcium and calcitriol.      Researchers at the NIH have conducted prior studies to establish synthetic human parathyroid     hormone 1-34 (HPTH) as a treatment for hypoparathyroidism. Other studies have shown that PTH     may improve calcium levels in blood and urine. The primary purpose of this research study is     to evaluate the effects of synthetic human parathyroid hormone 1-34 (HPTH) replacement     therapy on bone in adults and teenagers with hypoparathyroidism.      The study takes 5 (Omega) years to complete and requires 12 inpatient visits to the National     Institutes of Health Clinical Center in Bethesda, MD. The first visit will help the study     team decide whether you are eligible. This visit will last 2 to 3 days. After taking calcium     and calcitriol for 1 - 7 months you will return to the NIH Clinical Center for the baseline     visit. The baseline visit is the visit that you will start your PTH; you will also undergo a     bone biopsy during the visit. The baseline visit may last 7 to 10 days. You will then take     PTH twice a day for 5 years. You will be asked to return to the NIH clinical center every 6     months for 10 follow-up visits. During one of the follow-up visits, you will have a second     bone biopsy taken from the other hip. That second biopsy will be done after 1 year, 2 years,     or 4 years of taking PTH; the researchers will assign the timing of the second biopsy     randomly. You will be asked to go to your local laboratory for blood and urine tests between     each follow up visit. At first the blood tests will occur at least once a week. Later, you     will need to go to your local laboratory for blood tests at least once a month and urine     tests once every 3 months. The local laboratory visits and follow-up visits at the NIH     Clinical Center will help the study team determine whether the HPTH treatment is controlling     your hypoparathyroidism.   "
195245|NCT00395551|"     The purpose of this study is to determine whether ranibizumab is effective in the treatment     of choroidal neovascularization secondary to causes other then wet macular-degeneration.   "
195246|NCT00395564|"     The investigator intends to review retrospective de-identified data of patients who have had     Open, Laparoscopic, Ureteroscopic or Percutaneous Urologic Surgery.   "
195249|NCT00395603|"     To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in     reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.   "
195788|NCT00408915|"     The aim of the study is to evaluate the long-term efficacy, local tolerability and safety of     Lisuride applied as subcutaneous infusion compared to placebo in patients with advanced     Parkinson's disease with motor fluctuations and OFF periods refractory to conventional     treatment.   "
195250|NCT00395616|"     Humeral lateral epicondylitis or tennis elbow is a common painful elbow disorder. The cause     of tennis elbow is the chronic overload of bone-tendon junction. High prevalence of tennis     elbow has a direct impact on the workplace productivity and quality of life. Steroid     injection is the very few methods proved to have short-term efficacy in tennis elbow     treatment, but it has potential adverse effects like tendon rupture. Temporary paralysis of     muscle after botulinum toxin injection may reduce the physical demands and facilitate the     normal repair mechanism during recovery. Preliminary studies suggested that botulinum toxin     injection is effective in treating tennis elbow. The objective of this study is to compare     the effects of botulinum toxin injection with corticosteroid injection in tennis elbow     treatment.   "
195251|NCT00395629|"     Brief Summary: This study was designed to explore a safe dose and characterize the     preliminary safety and efficacy of ICL670 in adult patients with previously documented     history of homozygous C282Y.   "
195252|NCT00395642|"     This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK     Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the     follow-up treatment of patients implanted with a Cardiac Resynchronization Therapy     Implantable Cardioverter Defibrillator (CRT-D). The feasibility study is designed to plan and     define endpoints for a larger randomized study. The study will assess the HM-parameter trends     correlation with daily weight and blood pressure changes. The patient compliance rate of the     two different telemonitoring systems (HM & ETM) will also be evaluated.   "
195253|NCT00395655|"     Aberrant DNA methylation and histone deacetylation participate in cancer development and     progression, as epigenetic alterations are common to breast cancer, in this phase II study,     the demethylating hydralazine plus the HDAC inhibitor magnesium valproate will be added to     neoadjuvant doxorubicin and cyclophosphamide in locally advanced breast cancer to assess     their safety and biological efficacy.   "
195254|NCT00395668|"     The purpose of this study is to investigate if electromagnetic radiation from TETRA handset     can influence cognitive function and the well-being of healthy adults. Furthermore, the     purpose is to provide any special information about the subjects which can cause the possible     reactions.   "
195255|NCT00395681|"     Rationale: The extreme increase of obesity in the last years had led to this study. There is     no consensus about how to anaesthetise morbidly obese patients. The amounts of narcotics     given vary widely and rather depend on the anaesthetist than on the pharmacokinetics and     dynamics in the morbidly obese patient. Reason for this is that it is not clear in what     extend the pharmacokinetics and dynamics are affected in the morbidly obese patient.      Objective: The study is performed in order to develop a population pharmacokinetic and     pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia in     the morbidly obese patient (BMI > 40). A covariate analysis will be performed in order to     account for variability in pharmacokinetic and/or pharmacodynamic parameters. This model will     take into account patient and procedure bound covariates. The results will be used to develop     individualised dosing schemes of Propofol when used for induction and maintenance of     anaesthesia in morbidly obese patients.      Study design: A randomised, therapeutic and non-invasive study.      Study population: Morbidly obese patients with a Body Mass Index > 40 undergoing laparoscopic     banding or gastric bypass surgery, 18-60 year old.      Intervention (if applicable): Patients will be randomised into two groups, one group will be     given 200 milligrams of Propofol and the other group will be given 350 milligrams of     Propofol. During the induction of anaesthesia with Propofol over 60 seconds, the patient is     asked to count in order to measure time to induction of anaesthesia. During and following     anaesthesia a maximum of 50 ml of blood will be taken from an indwelling arterial line. Depth     of sedation will be measured using non-invasive Bispectral Index (target 40-60) and other     standard measures (heart frequency and blood pressure).      Main study parameters/endpoints: Primary endpoints: pharmacokinetic parameters; clearance,     intercompartmental clearance, volume of central compartment and volume of peripheral     compartment.      Secondary endpoints: pharmacodynamic parameters; time to induction of anaesthesia (stop     counting, eyelash reflex, quality of anaesthesia, corresponding dose required for induction     of anaesthesia for both induction doses), EC50 using BIS, required doses of Propofol during     maintenance of anaesthesia, wake-up time.      Nature and extent of the burden and risks associated with participation benefit and group     relatedness: A maximum amount of 50 milliliters of blood will be sampled from an indwelling     arterial line. The patient will be asked to count slowly during induction of anaesthesia.     Both induction doses of 200 and 350 milligrams are currently used standard induction doses     for morbidly obese patients.   "
195256|NCT00395694|"     To evaluate safety information of BW430C when administered using the lower starting doses and     slower dose escalations as recommended Global Data Sheet   "
195257|NCT00395707|"     The primary objective of this study is to determine the safety & efficacy of ranibizumab for     the treatment of retinal angiomatous proliferation secondary to age related macular     degeneration.   "
195258|NCT00395720|"     This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who     are infected with HIV. In phase I studies, a single vaccination with MVA85A, when     administered at a dose of 5 x 10^7pfu intradermally, has been shown to be safe in both     mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected     individuals. Additionally, 5 x 10^7 pfu MVA containing HIV antigens administered twice, 4     weeks apart, in HIV positive individuals, is safe. We will use 5 x 107 pfu MVA85A     intradermally in this study. Subjects will be identified from HIV clinics in the Oxford     Radcliffe Hospitals NHS Trust and also from Swindon and Marlborough NHS Trust and St. Mary's     Hospital NHS Trust if our recruitment targets are not met.   "
195259|NCT00395733|"     The purpose of this study is to determine if the contrast agent is effective and safe in the     Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.   "
195260|NCT00395746|"     This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic     control of liraglutide in combination with sulphonylurea agent (SU) compared to SU     monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2     diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a     randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.   "
195261|NCT00395759|"     The purpose of this study is to investigate how the addition of a new artificial tear product     when applied to the tear layer affects contrast sensitivity and optical aberrations over     time. We will also determine if there are any adverse effects associated with drop     instillation.   "
195275|NCT00395941|"     Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid     control of moderate to severe chronic plaque type psoriasis.   "
195262|NCT00395772|"     The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the     safety and effectiveness of this new drug with the standard way of treatment of deep vein     thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new     events of thrombosis and pulmonary embolism and bleeding risk.   "
195263|NCT00395785|"     The purpose of this study is to evaluate the safety and efficacy of the TriActiv® ProGuard™     System when used during a stent placement in a blockage within the carotid artery in patients     considered to be at high risk for complications from surgical endarterectomy.   "
195264|NCT00395798|"     Objectives:The purpose of this study is to determine if use of nech collar (stiff or     soft)will improve the possibility to obtain painrelief in patients with cervical radicular     pain. We will compare short term (six weeks and three months) and long term ( one year)     effect of six weeks use of neck collar (stiff or soft)together with neck school information     with neck school information alone.   "
195265|NCT00395811|"     The purpose of this study is to determine whether intracoronary transfer of autologous bone     marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion,     and finally resulting in improved systolic and diastolic left ventricular function in     patients with myocardial infarction.      50 patients with stable left ventricle function will - with six months interval - receive two     treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional     myocardial territories and Coronary Artery Bypass Graft (CABG).   "
195266|NCT00395824|"     Hemodialysis causes contact activation of the coagulation pathway (1). For this reason,     unfractionated or low molecular weight heparins are administered in daily practice to prevent     thrombosis of the dialyzer and blood circuit, but the dose commonly used causes systemic     anticoagulation. This can cause serious complications in patients with high risk of bleeding.     Regional and low-dose heparinization, use of prostacycline, regional citrate anticoagulation     (RCA), and high-flow-rate hemodialysis without anticoagulation have been shown to reduce     bleeding complications. Each of these methods, however, is characterized by its own technical     difficulties, limitations, or complications.      The present study aimed to compare the efficacy and safety of heparin-coated     polyacrylonitrile membranes (AN69ST) and regional citrate anticoagulation in hemodialysis     patients at risk of bleeding   "
195267|NCT00395837|"     To assess the impact of lifestylel changes upon measures of wellness and aging, in particular     weight change, fitness measures, and cognitive performance. The hypothesis was that aerobic     exercise would improve mental performance and measures of fitness.   "
195268|NCT00395850|"     This study examines the influence of dopamine beta-hydroxylase enzyme activity on the     clinical efficacy of the novel pharmacotherapy, disulfiram, for treating cocaine dependence     in cocaine-dependent patients, some of whom are opioid dependent and maintained on an     FDA-approved opioid agonist. Cocaine dependence as well as co-morbid cocaine and     opioid-dependence is associated with more public health issues and poorer treatment prognosis     when admitted to methadone maintenance. Yet no effective pharmacotherapies have been     developed to treat cocaine dependence to date. One novel pharmacotherapy, disulfiram, has     shown some promise as a treatment for this disorder in several clinical trials at a dose of     250 mg/day or more (e.g., Carroll et al., 1998, 2004). This 14-week, randomized, double blind     clinical trial will provide treatment for up to160 cocaine-dependent individuals, aged 18-65     years. Participants who are opioid dependent will be stabilized on methadone maintenance     during the first 2 weeks and baseline cocaine use will be assessed; participants will be     stratified by DBH genotype and randomly assigned to receive disulfiram at either 0, 250, 375     or 500 mg/day. During induction onto methadone for opioid dependent individuals, participants     are administered increasing doses of methadone on a daily basis until maintenance doses are     attained. At the beginning of week 3, participants receive methadone, if relevant, plus     disulfiram or placebo disulfiram according to their randomized assignments, and are     maintained on study medication(s) through week 14. At the end of the study, participants will     undergo detoxification from the opioid agonist, if relevant, and active/placebo medication     over a 4- to 6-week period. All participants receive weekly 1-hour psychotherapy (Cognitive     Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy     and who will receive ongoing supervision. Participants undergo a delay discounting session     during week 1. The primary outcomes will be retention, reduction in opioid and cocaine use,     as assessed by self-report and confirmed by thrice-weekly urinalyses, and disulfiram     side-effects profile. Secondary outcomes will include reductions in other illicit drug and     alcohol use, and improvements in psychosocial functioning. The prognostic relevance of     genotype at the DBH locus, DβH activity, etc., on response to disulfiram will be examined.   "
195269|NCT00395863|"     The purpose of this study is to evaluate whether Multihance is superior to Magnevist in terms     of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for     the visualization of brain disease.   "
195270|NCT00395876|"     This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted     at 24 centers in the United States and Canada. 100 adult and pediatric patients with     dysfunctional central venous catheters (CVCs) were randomly assigned in a 1:1 ratio to     receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).   "
195271|NCT00395889|"     The purpose of this study is to compare participation in physical activities in daily life     and functional outcomes of lung transplant recipients attending a six-month multicomponent     rehabilitation program including exercise training against others receiving only instructions     on how to increase their participation in physical activities in daily life.   "
195272|NCT00395902|"     Retrospective chart review to gather information on Sensipar patterns of use and effects on     biochemical parameters in renal transplant recipients   "
195273|NCT00395915|"     The principal clinical question to be answered by CHAT (Clozapine Haloperidol Aripiprazole     Trial) is the relative efficacy and tolerability of combination treatment with clozapine plus     aripiprazole compared to combination treatment with clozapine plus haloperidol in patients     with an incomplete response to treatment with clozapine over an appropriate period of time.   "
195274|NCT00395928|"     Impairment of relaxation, the early phase of ventricular diastole is the first stage of heart     diastolic dysfunction. Left ventricular diastolic function can be determined noninvasively by     Echo- Doppler – derived mitral valve flow velocities. The addition of pulmonary venous flow     pattern enables more accurate assessment of left ventricle diastolic function. The role of     the right ventricle in haemodynamic function of the heart is now emphasized. The right     ventricle diastolic function can be assess by recording the Doppler tricuspid valve flow     pattern. Impaired LV diastolic function usually precedes systolic dysfunction and may cause     clinical signs of congestive heart failure. Cigarette smoking is one of the major risk     factors for cardiovascular diseases. The aim of the study was to assess left and right     ventricular diastolic function in healthy, young and slim smokers before and after smoking     one cigarette.      Echocardiographic examination: before and after smoking one cigarette Echocardiographic     evaluation of mitral valve flow, pulmonary venous flow, tricuspid valve flow and hepatic vein     flow to assess diastolic function of ventricles.   "
195276|NCT00395954|"     The hypothesis underlying this study is that failure to recognise the role of lactose     intolerance among patients has led to inappropriate dietary advice and treatment with drugs     that contain lactose as a filler. These failures exacerbate symptoms and lead to the     unnecessary use of immune suppressant drugs.      This study will identify the threshold at which symptoms of lactose intolerance develop, to     provide appropriate advice and treatment in the management of patients.   "
195828|NCT00409435|"     This is a 3-day study comparing pyridostigmine versus placebo in the treatment of postural     tachycardia syndrome (POTS). The researchers expect pyridostigmine to improve tachycardia and     stabilize blood pressure.   "
195277|NCT00395967|"     This Phase 2 study was designed to assess the safety and hematological activity of AMD3100     (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were     predicted to be unable to mobilize ≥2*10^6 CD34+ cells/kg within 3 apheresis days. Patients     with NHL and MM were eligible to enter the study if they had undergone cyto-reductive     chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion     criteria.      The purpose of this protocol was to determine whether plerixafor in combination with     Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of     peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low     after treatment with G-CSF alone, whether it was safe, and whether transplantation with the     apheresis product was successful, as measured by time to engraftment of polymorphonuclear     leukocytes (PMNs) and platelets (PLTs).   "
195278|NCT00395980|"     Using healthy volunteers, participants will lay on an operating room table in various     positions employed during kidney surgery. Using a pressure sensor mat, we hope to determine     which areas of the body are subject to higher pressures. Using padding devices (foam, gel,     water mattress)which are currently used in the operating room will be employed and     measurements will be taken to determine which padding material and configurations is optimal     to reduce the pressure to those body parts at risk for excessive pressure subject during     laparoscopic surgery.   "
195279|NCT00395993|"     This study compares of the safety and efficacy of intravenous iron vs oral iron in the     treatment of anemia secondary to heavy uterine bleeding   "
195280|NCT00396006|"     The purpose of this study is to evaluate the effects of weekly augmentation therapy with     ARALAST Fraction IV-1 (Fr IV-1) on epithelial lining fluid (ELF) alpha 1-proteinase inhibitor     levels and other ELF analytes and to assess the safety of the treatment. Eligible subjects     with a diagnosis of severe congenital alpha 1-antitrypsin deficiency will receive 8     consecutive weekly treatments with 60 mg/kg/week of functional ARALAST Fr IV-1 administered     intravenously. The efficacy and safety assessments will include two bronchoscopies with     bronchoalveolar lavage on study initiation and on study termination and multiple imaging and     laboratory safety assessments. Each subject will participate for a minimum of 12 weeks.   "
195281|NCT00396019|"     This study is for slow growing tumors called plexiform neurofibromas (PNF) which are a     relatively common problem in people with neurofibromatosis type 1 (NF1). These tumors are     benign but as they grow, they can become disfiguring as well as disabling or even life     threatening. They often cause pain, difficulty using arms or legs because of spinal cord     compression, and/or nerve damage. At present, the only available therapy for plexiform     neurofibromas is to try to surgically remove as much of the tumor as is possible. Because     these tumors grow into the surrounding areas, total surgical resection is often impossible.     Most tumors will re-grow after surgery if the entire tumor cannot be removed. To date, other     treatments including chemotherapy and radiotherapy have not been able to shrink these tumors.      Interferon is a drug that is used for different types of tumors as well as for hepatitis. It     has been used in the treatment of plexiform neurofibromas (PNF) with some subjects showing     improvement in symptoms and/or a decrease in the size of the tumor. Most subjects had no     further growth of their tumor while on the PEG-Intron. The drug used in this study is PEG     (pegylated)-Intron. PEG-Intron is a long acting form of interferon which keeps the drug from     being broken down in the body for a longer period of time and potentially could be more     effective than the short-acting interferon. PEG-Intron has been approved by the Food and Drug     Administration (FDA) for the treatment of Hepatitis C.      The goals of this study are:        1. To determine how your child's plexiform neurofibroma responds to PEG-Intron when given          weekly.        2. To determine the side effects of PEG-Intron when given weekly to participants with          plexiform neurofibromas.        3. To evaluate a new method of measuring changes in the size of tumors called volume          analysis. This method measures the entire volume of a tumor in three dimensions. The          standard method of measuring tumors uses only the length and/or width of the tumor. By          studying the different ways of measuring tumors the investigators hope to be able to          determine which method is the most accurate and useful.   "
195282|NCT00396032|"     This was a Phase III, randomized, double-blind, placebo-controlled study conducted at 37     centers in the United States. 150 subjects ≥ 16 years of age who required hemodialysis (HD)     and had a dysfunctional HD catheter were enrolled in the study.   "
195283|NCT00396045|"     The purpose of this study is to evaluate the safety and efficacy of the association of     Melphalan/Prednisone/Revlimid (MPR) as induction treatment for newly diagnosed myeloma     patients over age 65 or those under 65 years who refuse or are not eligible for high dose     therapy. This association might further increase the response rate achieved by the standard     oral MP regimen.   "
195284|NCT00396058|"     The purpose of the study is to determine whether methylphenidate facilitates so called     short-term plasticity as measures with transcranial magnetic stimulation, in patients with     stroke.   "
195285|NCT00396071|"     This mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin     secretion to improve the incretin effect in patients with type 2 diabetes.   "
195286|NCT00396084|"     This study will evaluate the ability of 4 antibiotics to kill the bacteria that cause     tuberculosis (TB). The antibiotics to be studied are linezolid, gatifloxacin, levofloxacin,     and moxifloxacin. All are approved by the Brazilian health authorities to treat infections     caused by germs other than TB. Seventy human immunodeficiency virus (HIV)-negative adults,     aged 18-65 years, who have been newly diagnosed with pulmonary (lung) TB, will participate in     this study. Study volunteers will be given one of the 4 study drugs or a comparison     antibiotic, Isoniazid, which has been used around the world as a standard of care treatment     for TB. Volunteers will stay in the hospital for 10 days and be given a study antibiotic 7 of     those days. Blood and saliva samples will be taken. Six weeks later, volunteers will return     for a final health check. All volunteers will receive 6 months of standard tuberculosis     treatment.   "
195287|NCT00396097|"     To demonstrate that an individualized, formula-based Genotropin regimen for children with     Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th     percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to     explore treatment efficiency over four years of two formula-based dose regimens (sub-arms)     compared to standard treatment   "
195316|NCT00396474|"     The purpose of this study is to demonstrate that insulin sensitivity is not different between     growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort     of subjects matched by gender and body mass index (BMI) who are not treated with growth     hormone (GH) and who remain short at final height.   "
195288|NCT00396110|"     In this study the effect of the switch to rosuvastatin from another statin (fluvastatin,     pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without     evident CHD and LDL-C ≥ 3.2 mmol/l. This was done in a large observational study (TARGET)     representing daily practice. Primary end points analysis was the percentage of patients     reaching the target of LDL-C < 3.2 mmol/l. Secondary outcomes were the changes of LDL-C,     HDL-C, TC, Triglycerides (TG) and TC/HDL-C-ratio from baseline.   "
195289|NCT00396123|"     Humans have cells in their blood stream called endothelial progenitor cells or EPCs. These     are thought to be important in keeping blood vessels healthy. People with chronic kidney     disease (CKD) have low numbers of these cells. People with cardiovascular (heart and blood     vessel) disease also have low numbers. Patients with CKD have more cardiovascular disease     then any other group.Erythropoietin is a hormone made by the kidneys. It is essential for     making red blood cells and also activates EPCs. It is low in people with kidney disease.      As part of your regular medical care for correcting your low red blood cell count, you will     be receiving a medication that acts like erythropoietin. It is called darbepoetin.      The purpose of this study is to see if darbepoetin treatment affects EPC numbers and     function.   "
195290|NCT00396136|"     The objective of this post approval registry is to confirm the long-term safety and     effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in     conjunction with a BIOTRONK cardiac resynchronization therapy defibrillator (CRT-D). The     Corox OTW Steroid LV Lead is capable of providing permanent pacing therapy to the left     ventricle in a CRT-D system. The following are the specific objectives to be evaluated during     this post-approval registry:        -  Long-term effectiveness of the COROX OTW Steroid in providing biventricular pacing        -  Safety of the COROX OTW Steroid LV pacing lead   "
195291|NCT00396149|"     To investigate the safety and tolerability of successive single rising doses of SLIT in     subjects with allergic rhinitis and to investigate the safety and tolerability of multi high     dose regimens of SLIT in subjects with allergic rhinitis.   "
195292|NCT00396162|"     Chronic sinusitis is reported to be one of the most widespread disorders in the United     States. It can be caused by a variety of reasons such as allergy, infection and/or defects in     T-cells which help regulate immune function. Medication and other costs related to treatment     of nasal and sinus infections are estimated to be more than $60 million annually putting a     considerable strain on the economy of health care.      Probiotics are live microorganisms that are normally present in the gut of a healthy     individual. They are also known as friendly bacteria and have been used to help maintain     the normal functioning of the immune system. They are safe and are commercially available in     the form of yoghurt, sachets, chewable tablets or flavored capsules. Since a number of nasal     and sinus disorders are related to allergy and improper functioning of the immune system, we     hypothesize that regular use of probiotics may help improve chronic nasal and sinus symptoms     by boosting immune responses.      The project we propose is novel because it would be the first study evaluating the usefulness     of probiotics for the larger population having chronic sinusitis rather than those having     only allergic symptoms. We aim to assess whether regular use of probiotics will help improve     symptoms of chronic sinusitis and will have a greater effect than placebo in this regard.   "
195293|NCT00396175|"     A clinical study to collect additional data in order to characterize the reduction in PSA     with finasteride 1 mg, and its reversibility in men with androgenetic alopecia between the     ages of 40 to 60 years.   "
195294|NCT00396188|"     The purpose of this study is to determine the ability of a proprietary software screening     tool to discriminate normal corneas (front surface of the eye) from previously diagnosed     corneal conditions (diseases/surgeries/pathologies) and to determine the repeatabiltity and     reproducibility of the Atlas II corneal topographer in normal human corneas.   "
195295|NCT00396201|"     Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive     chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the     inclusion/exclusion criteria are eligible to enter this efficacy, safety and pharmacokinetic     (PK) study. The only changes to the standard of care is the addition of plerixafor to a     granulocyte-colony stimulating factor (G-CSF) mobilization regimen on each day prior to     apheresis. The purpose of this protocol is to determine the proportion of participants who     reach a target number of CD34+ stem cells (≥5*10^6 cells/kg) after hematopoietic stem cell     mobilization with G-CSF and plerixafor. Safety and PK parameters are also collected.   "
195296|NCT00396214|"     The primary objective of the study is to evaluate changes in weight short and long term with     bifeprunox and quetiapine. Study participation for the subject is 57 weeks.   "
195297|NCT00396227|"     This study is designed to evaluate, in a primary care setting, the safety and efficacy of     vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients     with type 2 diabetes inadequately controlled by metformin alone.   "
195298|NCT00396240|"     24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin     plus initiatives to improve compliance. If the subject does not reach the EAS LDL-C treatment     goal at week 12, rosuvastatin will be titrated from 10mg to 20mg.   "
195299|NCT00396253|"     This was a Phase III, open-label study conducted at 44 centers in the United States, Canada,     and Puerto Rico. 223 subjects who required hemodialysis (HD) and had a dysfunctional HD     catheter were enrolled in the study.   "
195300|NCT00396266|"     This study evaluates the safety and efficacy of plerixafor given in addition to     granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells     (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and     multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating     CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor     (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN)     engraftment after transplantation. Data from this protocol will assist in the determination     of the dosing schedule for future studies.   "
195301|NCT00396279|"     To determine how safe and effective denosumab is in treating patients with giant cell tumor     of bone.   "
195302|NCT00396292|"     This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who     display postpartum anemia.   "
195317|NCT00396487|"     To compare the response rate of single agent chemotherapy in advanced colorectal cancer given     as standard treatment versus tailored treatment in a randomised phase III trial.   "
195557|NCT00407186|"     The purpose of this study is to evaluate the efficacy and safety of combined chemotherapy and     radiotherapy (in comparison to chemotherapy alone) as adjuvant treatment after surgery for     gastric cancer. Prior to surgery all patients will receive neo-adjuvant chemotherapy as well.   "
195303|NCT00396305|"     This research study is being done because influenza (flu) affects many people each year     throughout the world. The elderly and those with chronic health problems are at greater risk     for complications from the flu. The purpose of this research study is to evaluate vaccination     strategies in the elderly and others receiving the influenza vaccination in order to increase     protection. All subjects will receive the flu vaccine as an injection in the muscle of the     upper arm. Participants may receive a booster [an extra dose of vaccine or placebo (inactive     substance)] shot. Study participants will include healthy adult volunteers, ages 21-40,     60-89, or 90 years and older. Subjects will be involved in study related procedures for 6     months.   "
195304|NCT00396318|"     This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the     United States and Canada. 251 adult and pediatric patients with dysfunctional central venous     catheters (CVCs) were enrolled in the study and treated with one or two doses of     tenecteplase.   "
195305|NCT00396331|"     This study evaluates the safety, efficacy, and pharmacokinetics (PK) of plerixafor given in     addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood     stem cells (PBSCs) for autologous transplantation in patients who would benefit from an     autologous stem cell transplant but have failed previous collections or collection attempts     with a mobilization regimen of G-CSF alone, chemotherapy and G-CSF, or any other conventional     therapy including cytokines, chemotherapy and cytokines and bone marrow harvests.      The only change to standard of care of a mobilization regimen that includes G-CSF is the     addition of a dose of AMD3100 (plerixafor) on the evening prior to each day of apheresis.      Efficacy outcomes include quantification of CD34+ cells in the apheresis product and     assessment of successful polymorphonuclear leukocyte (PMN) and platelet (PLT) engraftment     after transplantation. PK outcomes include analysis of repeated doses of plerixafor.   "
195306|NCT00396344|"     The purpose of the research is to study a common and dangerous medical condition called     'septic shock' that often occurs in critically ill patients. In order to learn about septic     shock in humans, we will administer a substance called 'endotoxin' to participants in this     study. Endotoxin causes a temporary period of inflammation in the human body, a brief     'virtual' infection. This is an established method for the investigation of inflammation     properties. We are interested in how the natural hormone, cortisol, can affect the human     response to endotoxin. We know that when cortisol is given at the same time as endotoxin it     can decrease the inflammation that occurs due to endotoxin. In this study we will test     whether or not cortisol, when given the day before the endotoxin, will work to change the     inflammation that occurs due to endotoxin. In order to test this, two-thirds of the study     participants will receive cortisol on the day before they receive the endotoxin and one-third     of the study participants will receive a placebo (no medication) before the endotoxin.   "
195307|NCT00396357|"     This study is designed to evaluate the efficacy and safety of vildagliptin in combination     with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.   "
195308|NCT00396370|"     This study will assess the safety of a Bacillus Calmette-Guérin (BCG) vaccine against     tuberculosis (TB) and will evaluate if giving the vaccine by mouth, injection, or by both     methods produces greater results. BCG vaccine and/or placebo (substance containing no     medication) will be given by mouth and/or by injection into the skin. This study, conducted     at Saint Louis University, will enroll 60 (up to 80) healthy volunteers, 18-40 years old, who     are negative for a TB test (QuantiFERON®-Gold) and human immunodeficiency virus (HIV). Study     procedures will include a physical exam; review of TB exposure history and medical history;     collection of multiple samples of blood, urine, stool, tears, and nose fluid; and skin and     blood tests for TB. Volunteers may participate for about 24 months.   "
195309|NCT00396383|"     This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and     well tolerated in multiple myeloma (MM) patients. In addition, this study determines if     plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for     transplantation in MM patients. The minimum number of CD34+ cells to collect is 2*10^6 CD34+     cells/kg and the target is ≧4*10^6 CD34+ cells/kg. Success of transplant engraftment will be     measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT)     engraftment. Durability of transplant will be assessed for a minimum of one year.   "
195310|NCT00396396|"     The purpose of this study is to investigate the exact role of Acetylcysteine (Mucomyst) in     altering creatinine clearance. Prior studies have shown the protective effects of     Acetylcysteine on contrast-induced renal dysfunction. In these studies, Acetylcysteine     lowered the incidence of serum creatinine elevation after administration of radiographic     contrast agents. Not only was the increase in serum creatinine prevented, the studies also     demonstrated a significant increase in creatinine clearance after administration of the     agent. These prior studies did not evaluate if the increase in creatinine clearance was     indeed from a protective benefit of Acetylcysteine in preserving the GFR versus simply     increasing the proximal tubular creatinine secretion without actually affecting the GFR. We     propose an experiment to help support our hypothesis that Acetylcysteine increases creatinine     clearance via an increase in proximal tubular secretion of creatinine.   "
195311|NCT00396409|"     Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy     (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid     seasonal allergic rhinoconjunctivitis.   "
195312|NCT00396422|"     The primary objective of the study is to evaluate the safety and tolerability of 50, 100,     200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with plaque psoriasis   "
195313|NCT00396435|"     The purpose of this study is to evaluate, on renal transplanted patients with CGD, the effect     of two levels of haemoglobin on quality of life at 6 months and the speed of progression of     renal function degradation at 24 months.      This study will recruit 140 patients in 21 centers in France.   "
195314|NCT00396448|"     The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in     obese adults   "
195315|NCT00396461|"     This study aims to analyse the effect of two total parenteral nutrition diets with lipid     emulsions of different compositions on the incidence of nosocomial infection in critical     patients. One diet will contain an MCT/LCT emulsion concentrated to 20% (50:50 ratio) and the     other will comprise an MCT/LCT/fish oil emulsion (50:40:10 ratio). The secondary objective of     this study is to analyse mortality in hospital and up to 6 months of discharge.   "
195318|NCT00396500|"     Background. More than a third of the world’s population is infected with intestinal     nematodes. A majority of these infections occur in children. Current control approaches     emphasise treatment of school age children, and there is a lack of information on the effects     of deworming preschool childrenSetting: Within the Integrated Child Development System (ICDS)     infrastructure in urban Lucknow (UP), IndiaDesign: Open Labeled randomised trialHypothesis:     Our study hypothesis was that albendazole administration six monthly, as a single 400 mg dose     in syrup, by the existing health care delivery system would be a practicable way to achieve     mass deworming of preschool children and this might result in an improvement in weight gain     of preschool childrenIntervention One group will receive usual health care by the existing     health care staff, which included six monthly administration of Vitamin A concentrate. The     other group will receive, in addition, 400 mg of albendazole (Zentel, Smith Kline & Beecham)     in 10 ml syrup form. Five such doses will be given at six monthly intervals for 2 years.Main     objective: To assess the impact of 6 monthly deworming on weight and height gain at the end     of 2 years in children aged 1 to 5 years of age Main outcomes measures: Weight gain in 2     yearsInclusion criteria: Children 1 to 5 years, whose guardians give written informed     consent. Exclusion criteria: Those not consentingSample size: Sample size was calculated for     a continuous outcome. For a standardized effect size of 0.1, with a power of 80% and an alpha     level of 0.05, using a 2-tailed t test, taking into account design effect, about 2000     children will be included in each arm.   "
195319|NCT00396513|"     The purpose of this study is to compare effects of statins (simvastatin) and metformin on     clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic     (lipids, markers of systemic inflammation), and endothelial function parameters in women with     polycystic ovary syndrome (PCOS).   "
195320|NCT00396526|"     Background: With documented rise in bacterial resistance in vitro to co-trimoxazole, there is     a need to document in vivo effectiveness of the drug in treatment of non-severe pneumonia in     the community setting.      Setting: The study will be conducted in 18 rural primary health center (PHC) in 9 districts     in India near Lucknow, Nagpur, New Delhi, Mumbai, Chennai, Trivandrum, Vellore, Chandigarh     and Bhopal.      Design: The unit of randomization will be the PHC. The recruited children will be followed up     on days 4, 6 and 13-15 to assess primary and secondary outcome measures.      Hypothesis: The primary hypothesis is that the clinical failure rate with use of either oral     amoxycillin for three days or five days co-trimoxazole is similar.      Intervention: Oral Co-trimoxazole (8mg/kg/day trimithoprim) twice a day for five days vs.     oral amoxycillin (20 mg/kg/day) thrice a day for three days.      Main objective: To compare the proportion of children aged 2 to 59 months presenting with     non-severe pneumonia with or without wheeze, who do achieve clinical cure on day 6 on     treatment with 5 days oral co-trimoxazole and 3 day oral amoxycillin, respectively.      Main outcomes measures: Clinical cure on day 6; clinical failure between day 1-6; clinical     relapse between day 7-15.      Inclusion criteria: Children aged 2-59 months with non-severe pneumonia based on WHO criteria     of respiratory rate above the age specific cut-off with or without wheeze, accessible to     follow up, whose guardians give written informed consent.      Exclusion criteria: Children with severe disease, other infectious disease requiring     antibiotic treatment, documented use of antibiotic for the last 48 hours, three or more     episodes of wheezing in a year, diagnosed asthmatics, known immunodeficiency disease, acute     or chronic organic disease, history of hospitalization within last 15 days, measles within     last one month, drug allergy, refusal to give consent, prior enrollment in the study.      Sample size: Has been calculated to test the null hypothesis. There will be 1100 children in     each arm. Thus each PHC is required to recruit a minimum of 122 cases within one year.      Policy relevance: The findings of the study can effect the ARI management policy. If the     current study proves that three day amoxycillin is clinically as effective as five day     co-trimoxazole and with the well documented evidence of rising resistance to co-trimoxazole,     short course amoxycillin may become the first line treatment for non-severe pneumonia Time     line: 18 months. Pilot in March 2003, enrollments from April 2003, Interim analysis Nov.     2003, DMC meet Dec. 2003, Data cleaning June 2004, DMC meet July 2004, Manuscript writing     Aug.2004.   "
195321|NCT00396539|"     Oral malodor is a common condition. In most cases this condition results from the proteolytic     activity of anaerobic oral bacteria. These bacteria produce volatile sulfide compounds which     are fowl smelling and are felt during exhalation and speech. the aim of the present study is     to examine a simple method of detecting these bacteria in samples taken from the oral cavity     of oral malodor patients.   "
195322|NCT00396552|"     Obsessive-compulsive disorder (OCD) is a severe psychiatric condition with only limited     response to current first-line treatments, comprising pharmacotherapy and     cognitive-behavioural therapy. Repetitive transcranial magnetic stimulation (rTMS) is a     relatively new technique which has shown great promise in the treatment of refractory mood     disorders, and schizophrenia, by alteration of brain activity. Previous work has demonstrated     altered cortical excitability in OCD and preliminary studies have suggested that rTMS may     have therapeutic potential in OCD. This pilot study will investigate the effectiveness of     rTMS for treatment-refractory OCD, and establish appropriate treatment parameters. In     addition, mechanisms whereby rTMS exerts its therapeutic effect will be explored using TMS to     evaluate cortical inhibition and measures of cognitive biases and processing.   "
195323|NCT00396565|"     The purpose of this study is to evaluate the effectiveness and safety of Extended Release     Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in     patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.   "
195324|NCT00396578|"     The purpose of this study was to determine the effect of aerosolized antibiotics on     respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized     antibiotics , which achieve high drug concentrations in the airway, would more effectively     treat respiratory infection, decrease the need for systemic antibiotics and decrease     antibiotic resistance.   "
195325|NCT00396591|"     The primary objective of this study was to compare the time between paracenteses before and     after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in     ovarian cancer participants with symptomatic malignant ascites.      The secondary objectives were to further assess efficacy and safety of Aflibercept treatment,     and the exploratory objectives were to assess pharmacokinetics, immunogenicity and     health-related quality of life.   "
195326|NCT00396604|"     The study is designed to obtain safety and efficacy data on three dose levels of indacaterol     when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of     treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg,     indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a     washout-period of 1 week.   "
195351|NCT00396929|"     The aim of the study is to examine the efficacy of Paclitaxel injection after a stent     implantation in patients with stenosis in native coronary arteries to prevent restenosis in     comparision with two admitted therapies.   "
195549|NCT00407082|"     This is a multi-center, randomized, double-masked, controlled study to evaluate the safety     and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of     subjects with non-infectious uveitis affecting the posterior segment of the eye. An     additional objective is to compare the safety and efficacy of two doses of fluocinolone     acetonide.   "
195327|NCT00396617|"     The benefits of this new material, as demonstrated in animal studies and preliminary studies     in man, could provide the answer to problems encountered by surgeons in the field of     phonatory implants. This novel application is a step towards resolving the very real problems     which still exist in the field today. The functional concept, which will allow better control     over integrating implants in tissue, should also, it is hoped, favour cellular colonization,     thereby fulfilling a currently unmet medical need. The aim is to avoid well-identified     potential complications linked to the use of silicone-only implants (with or without a     surface coating), like leakage around the prosthesis (by cellular colonization), and so     reduce the risk of protrusion/extrusion of the prosthesis as far as possible, and to avoid     trauma to the peri-prosthetic tissues by repeated interventions   "
195328|NCT00396630|"     The aim of this study is to explore horizontal transmission of the HRV vaccine strain within     a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
195329|NCT00396643|"     Early intervention in psychosis might be associated with better outcomes. However,     intervention in the pre-psychotic phase has been questioned as, using current criteria, only     20-50% of individuals classified as prodromal develop a psychotic disorder within a 1-2 years     period. Treatment agents investigated in the pre-psychotic phase of schizophrenia and other     psychotic disorders should, therefore, not have major side effects. This proposal     investigates omega-3 fatty acids (1.2 gramm per day eicosapentaenoic acid/docosahexaenoic     acid;EPA/DHA) as a beneficial and possible preventive therapeutic agent in young people at     ultra high-risk for developing a psychotic disorder.   "
195330|NCT00396656|"     This study evaluated the effect of valsartan on small vessel blood flow in patients with     mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.   "
195331|NCT00396669|"     Dopamine (DA) plays a critical role in nicotine (and other) addiction and this drug is known     to release DA in brain areas mediating reward and motivational processes. Although imaging     studies show that release of DA follows smoking, little is known regarding how common genetic     polymorphisms for three genes associated in some studies with smoking (dopamine D2 receptor,     dopamine and serotonin transporter) interact with smoking status and modulate individual     differences in nicotine-induced DA release and dopamine receptor occupancy, in vivo. The     current proposal combines brain imaging and genomics ('imaging genomics') towards partially     unraveling the complex relationship between smoking phenotype and common polymorphisms.     Understanding whether genetic factors contribute to inter-individual variability in smoking     is crucial for interpreting imaging results in the context of disease pathology. We     hypothesize that a model of vulnerability to addiction based on interactions between     genotype, receptor and transporter availability and in vivo nicotine-induced DA release will     elucidate some of the fundamental neurochemical and neurogenetic circuits underlying     addiction.   "
195332|NCT00396682|"     It has been shown that patients with advanced HCC have an increased frequency of CD4+CD25+     regulatory T cells. These cells might suppress tumor-specific immune responses.     Cyclophosphamide has been shown to reduce the frequency of CD4+CD25+ regulatory T cells. The     aim of this study is to test if the treatment with cyclophosphamide leads to a decrease in     the frequency of CD4+CD25+ regulatory T cells and to increase tumor specific immune responses     in patients with advanced HCC.   "
195333|NCT00396695|"     Traumatic events may lead to strong emotional episodic memories common in Post- Traumatic     Stress Disorder(PTSD). Intense affect may inhibit efficacy of glutamatergic neurotransmission     in two particular areas of the limbic system that have been implicated in the processing of     emotionally charged memories: the amygdala and the hippocampus(1,2).      Dysfunction of glutamatergic neurotransmission is associated with disbalance of long-term     potentiation (LTP) and long-term depression (LTD)- two underlying mechanisms that cooperate     to achieve synaptic plasticity and its expressations- learning and memory(3). LTP- the long     lasting enhancement of synaptic function includes changes in the amount of neurotransmitter     glutamate released into a synapse, changes in the levels of key proteins in synapses, protein     phosphorylation and changes the density of receptors on their synaptic membranes. LTD is the     inverse of LTP, a long lasting reduction in synaptic transmission (4). Interactions among the     different forms of plasticity underlie different forms of memories. Normally these mechanisms     are balanced.      In the current literature there is data that a class I major histocompatibility complex (MHC     class I) molecules, known to be important for immune responses to antigen, are expressed also     by neurons that undergo activity-dependence, long-term structural and synaptic modifications     (5). The brain produces its own immune molecules, the proteins MHC class I and CD3-zeta (a     component of receptors for MHC class I). In the immune system, the two proteins act as part     of a lock and key system to recognize and get rid of the body’s foreign invaders. The     CD3-zeta polypeptide is component of the T cell antigen receptor (TCR) which contribute to     its efficient cell surface expression and account for part of its transducing capability (6).      In the brain, they may be part of a signaling system that recognizes and eliminates     inappropriate neural connections. Expression of MHC class I is regulated by the naturally     occurring electrical activity, and sensitive to both natural and pathological changes in the     activity. Electrical activity of neurons drives to an establishment of the final pattern of     connection. Changes in the strength of individual synapses such as potention and depression     leads to stabilization and withdrawal, respectively, of the affected connections. There are     data, that in mice with deficiency of MHC class I and CD3-zeta the LTP in the hippocampus is     enhanced significantly and LTD is absent. Thus, MHC class I is crucial for translating     activity into changes in synaptic strength and neuronal connectivity in vivo. He required for     normal activity dependent potentiation, depression, removal of inappropriate connection and     responding to injury in the CNS (6).      Glutamate receptors play critical roles in LTP/LTD mechanisms. Some researchers consider that     a key role in pathogenesis of PTSD is being played by excessive excitation of NMDA-receptors     in limbic system structures (1). The existing data allows to assume, that equation of     plasticity mechanisms depends on mutual relations between the MHC class I and glutamate     receptors.      T-cells, like neurons, express high levels of glutamate receptors that are identical to the     brain glutamate receptors. Presence of ionotropic and metabotropic glutamate receptors in     membranes of lymphocytes makes them sensitive to the same alarm molecules which operate     neuronal activity. Glutamate by itself triggers several T-cell activation which differs     quantitatively or qualitatively from that ones triggered by “classical’ T-cell activators     like antigens(7). There are data about influence of T cell receptor-CD3 complex- on the     expression of T-cells glutamate receptors (8). It is possible, that the key roles in this     function play CD3-zeta.   "
195334|NCT00396708|"     This study aims to evaluate the effectiveness of using the myomo e100 wearable robotic     rehabilitation system for increasing functional independence and long term rehabilitation of     chronic stroke victims with a hemiparetic upper extremity.   "
195335|NCT00396721|"     The purpose of this study is to test in a pilot trial the efficacy and tolerance of sirolimus     oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.   "
195336|NCT00396734|"     The overall aim of this project is to use an advanced brain imaging technique, PET, in order     to monitor the progress of pharmacotherapy with modafinil or topiramate for cocaine     dependence in methadone-maintained patients who use cocaine in addition. Comparisons will be     made within the cocaine dependent methadone maintained subjects, between the start and end of     treatment, and between the two medications. This is the first systematic research study of     pharmacological treatment for cocaine dependence in Israel. This study is of major clinical     use, with implications for the treatment of cocaine dependence in poly-drug abusers in     Israel. Successful pharmacotherapy for cocaine dependence is expected in reduction in     cue-induced subjective craving and in glucose metabolism in brain areas elicited by cocaine     craving. Metabolic activity in regions that are activated by craving should be correlated     with dopamine DRD2 receptor occupancy in all patients.   "
195337|NCT00396747|"     The purpose of the study is to compare the effects of methotrexate (MTX) alone or in     combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected     synovitis, bone edema and erosive changes in early rheumatoid arthritis (RA) patients.   "
195338|NCT00396760|"     The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid     equally influence bleeding tendency and transfusion requirement in patients undergoing first     time cardiac procedures with a low risk of increased postoperative bleeding.Only patients     undergoing first time CABG or first time aortic valve replacement are included in this study.   "
195339|NCT00396773|"     Electrocoagulation effect of neonatal brain waves after cesarean section   "
195340|NCT00396786|"     The purpose of this study is to assess different doses of a new drug (BAY 59-7939), taken as     a tablet, are safe and can help prevent blood clots forming after a hip replacement     operation. Patients undergoing hip replacement surgery are at risk of developing blood clots.     To reduce this risk treatment to prevent clots forming is routinely given. The current     treatments can include injections under the skin or other treatments that need frequent blood     tests to monitor levels of drug in the body. Therefore there is a need for new drugs, which     are easier to give and need less monitoring.   "
195341|NCT00396799|"     The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated     estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated     estrogens tablets produced using a new manufacturing process   "
195550|NCT00407095|"     This study is a multicenter, 9 months, open label extension study for all patients who are     willing and eligible to continue from the pivotal, double-blind S308.3.002 study.   "
195342|NCT00396812|"     Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling,     pain, stiffness, damage, and ultimately loss of joint function. Scientists estimate that     about 1.3 million people (0.6 percent) of the U.S. adult population have RA. Current     therapies target the immune system early in the disease process before joint damage occurs,     and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents.     Rituximab is a disease-modifying antirheumatic drug (DMARD) recently approved by the FDA for     use in combination with MTX for treatment of moderately to severely active RA in patients who     have had an inadequate response to TNF-blocking agents, in an effort to try to slow the     course of the disease. This study will examine the effects of rituximab on the immune     response and disease activity in participants with early RA who have not been treated with     any disease-modifying agent. In addition, the safety and tolerability of rituximab in this     population will be examined.   "
195343|NCT00396825|"     The purpose of this Phase II SBIR study is a) to complete the adaptation begun in Phase I of     the ten skill modules of the Williams LifeSkills Video (WLV) for use by persons who are     caregivers for a relative with Alzheimer's Disease (AD) or other dementia, b) to script and     produce the complete Caregiver LifeSkills Video (CLV) and c) to conduct a randomized clinical     trial of the completed CLV to document benefits in terms of reduced psychosocial distress,     reduced biomarkers of stress and improved well being.   "
195344|NCT00396838|"     Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in     infants. Despite the short- and long-term adverse effects of pain, there are no guidelines     for the reduction of such pain. Previous studies evaluated different treatment modalities;     however, in most of them, pain response was assessed by subjective measures.      Aims of study: 1. To characterize the pain response of infants by using a computerized     analysis of the ECG. 2. To compare six different methods of pain reduction during heel     lancing in newborns.      Methods: The time, geometric and frequency domains of the infants' ECG will be computed     during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups:     breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying     with a pacifier and lying while getting a glucose solution. The differences in pain response     to these six treatment modalities will be assessed and compared to the infants' length of     cry, and scoring of the infants' behavioral response.   "
195345|NCT00396851|"     The study plans to compare the glucose-lowering effect of gurmar, a herbal preparation, with     metformin in patients with type 2 diabetes   "
195346|NCT00396864|"     Multicenter, open-label study of NPI-0052 in patients with advanced solid tumor malignancies     or refractory lymphoma whose disease had progressed after treatment with standard, approved     therapies that included 2 stages. The initial stage involved dose escalation to an MTD and     determination of a recommended Phase 2 dose. The second stage comprised an expansion cohort     at the recommended Phase 2 dose.   "
195347|NCT00396877|"     Contemporary management of cyanotic congenital heart disease includes three stages of     surgery. Incidence of shunt thrombosis and death between the two first stages of palliation     remains important.      The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day     for the reduction of all cause mortality and shunt related morbidity in neonates or infants     with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt     (e.g. modified Blalock Taussig Shunt [BTS]).      The secondary objective was to assess the safety of Clopidogrel in the study population.   "
195348|NCT00396890|"     This study will determine whether stimulation of the right side of the brain with repetitive     transcranial magnetic stimulation (rTMS) followed by stimulation of the left side with theta     burst stimulation (TBS) can temporarily change brain activity and improve hand movements in     subjects more than has recently been achieved with rTMS alone.      For rTMS, a wire coil is held on the patient's scalp. A brief electrical current is passed     through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a     click and may feel a pulling sensation on the skin under the coil. There may be a twitch in     the muscles of the face, arm or leg. The subject may be asked to tense certain muscles     slightly or perform other simple actions. The effect of TMS on the muscles is detected with     small metal disk electrodes taped to the skin of the arms or legs. This study uses two kinds     of rTMS. In one (Hz rTMS), magnetic pulses are given once per second for a period of 20     minutes; in the other (TBS), a series of pulses are given in bursts, each lasting 2 seconds,     for a period of 3 minutes.      Healthy normal volunteers between 18 and 55 years of age may be eligible for this study.     Participants undergo the following procedures during three visits to the NIH Clinical Center:      Visit 1:      Participants receive either real or sham rTMS applied on the right side of the brain followed     by real or sham TBS applied on the left side of the brain. In addition, subjects undergo the     following:       Pinch force: Subjects press a wedged instrument between the thumb and index finger as hard     as they can during several trials every 10 seconds.       Speed tapping: Subjects press a key on a computer keyboard as quickly as possible for 10     seconds, repeated for several trials.       Simple reaction time: Subjects respond as quickly as possible to a go signal presented on     a computer monitor by performing a quick wrist movement.       Electromyography: Subjects' muscle activity is recorded using electrodes (small metal     disks) filled with conductive gel and taped to the skin over the muscle.      Visits 2 and 3      Visit 2 is scheduled for one day after visit 1, and visit 3 is one week after visit 1.     Participants do not have brain stimulation during these two visits, but they have TMS     measurements, behavioral measurements, and electromyography (EMG) to see if the brain     stimulation done during the first visit is still present after a period of time.      At all three visits, participants comp...   "
195349|NCT00396903|"     During the insertion of epidural catheters several complications can occur, including     transient paraesthesia and inadvertent venous cannulation.      Reported incidences for paraesthesia vary widely between about 0.2% and 50% in different     articles, depending on the catheter (catheter material, soft-tipped or firm-tipped catheter),     the applied technique (lumbar or thoracic epidural anesthesia, depth of catheter insertion),     the approach (midline or paramedian) and the included patients (obstetrical or     non-obstetrical). Furthermore, the inconsistent definition of paraesthesia makes it     difficult to compare the results of different studies. Paraesthesia are not supposed to lead     to permanent neurological sequelea, but are unpleasant and perturbing sensations for the     patient.      For inadvertent venous cannulation during epidural catheter placement, incidences between 1%     and 14% have been reported. As for the paraesthesia rate, catheter material, technique,     approach and included patients are determinants for the incidence of vessel puncture.      Main objective of this study is to determine the incidence of paraesthesia with this     catheter.      Secondary objectives are to record        -  the frequency of inadvertent venous cannulation        -  difficulties involved in insertion and removal of the catheter        -  data on additional complications        -  data for the evaluation of handling characteristics   "
195350|NCT00396916|"     The purpose of the present study is to assess the role of hybrid PET/CT imaging diagnosis of     active malignancy in cancer patients with rising tumor markers after treatment and in the     diagnosis of primary tumor in patients with metastatic cancer of unknown origin. The clinical     impact of PET/CT in the management and treatment of these two groups of cancer patients will     be evaluated   "
195352|NCT00396942|"     This study will compare brain changes in people with Parkinson's disease with those of normal     control subjects while they learn motor skills. People with Parkinson's disease sometimes     have trouble learning new skills, but it is not known why. This study will use repetitive     transcranial magnetic stimulation (rTMS), nerve conduction studies, and     electroencephaolography (EEG) to look for differences in the way the brain changes with     learning in people with Parkinson's disease.      Healthy normal volunteers and people with Parkinson's disease who are between 21 and 80 years     of age may be eligible for this study. Participants undergo the following procedures in five     visits to the NIH Clinical Center:      Visit 1      Medical and neurological examination.      Visit 2      Motor training. Participants perform a pinching movement once every other second, timed to a     metronome, during rTMS. For TMS, a wire coil is held on the subject's scalp. A brief     electrical current is passed through the coil, creating a magnetic pulse that stimulates the     brain. The subject hears a click and may feel a pulling sensation on the skin under the coil.     There may be a twitch in the muscles of the face, arm or leg. rTMS involves repeated magnetic     pulses delivered in short bursts of impulses.      Visits 3 and 4      Brain physiology studies using rTMS, nerve conduction studies (electrical nerve stimulation)     and EEG. A nerve at the subject's wrist is stimulated with electrical impulses to measure the     speed with which nerves conduct electrical impulses and the strength of the connection     between the nerve and the muscle. rTMS is performed for 20 minutes. The EEG measures the     electrical activity of the brain (brain waves). For this test, electrodes (metal discs) are     placed on the scalp with a conductive gel and the brain waves are recorded while the subject     moves his or her thumb briskly for 20 minutes.      Visit 5      Subjects undergo rTMS for 20 minutes and have an EEG.   "
195353|NCT00396955|"     Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active     osteoarthritis (OA) of the knee.      Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among     dose levels. To assess health outcome measures. To assess the effect of PLA-695 on biomarkers     related to clinical responses. To assess PLA-695 exposure-response relationship on PD,     efficacy, and safety measures. To assess pharmacogenomics (PGX) analysis in OA.   "
195354|NCT00396968|"     AMD3100 given in combination with busulfan, fludarabine (and thymoglobulin (ATG) for     unrelated or HLA nonidentical donors) preparative regimen in patients with acute myelogenous     leukemia (AML) / myelodysplastic syndromes (MDS).      This study aims to determine if in AML and MDS patients there is a reduction of malignant     cells and enhanced elimination of the leukemia as assessed by progression free survival.     Secondary goals will be to assess effects on engraftment, graft versus host disease (GVHD)     and immune reconstitution.   "
195355|NCT00396981|"     Primary Objectives:        -  To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used          for the treatment of intracranial saccular aneurysms. TAR is defined as clinically          relevant recurrence resulting in: target aneurysm reintervention, rupture/re-rupture          and/or death from an unknown cause.        -  To correlate defined angiographic endpoints with TAR rates and assess their predictive          value, thereby providing a framework to establish clinically relevant endpoints for          future studies.      Secondary Objectives:        -  To evaluate device characteristics, incidence and severity of device-related adverse          events, including death, neurological deterioration and changes in functional abilities.        -  To establish angiographic recurrence rates for Matrix 2® and GDC® Coils used for the          treatment of intracranial saccular aneurysms.        -  To explore an experimental, quantitative and volumetric endpoint and correlate these          with existing qualitative assessments.   "
195356|NCT00396994|"     The purpose of this study is to determine if daily low magnitude, high frequency whole body     vibration can improve bone density in seniors.   "
195357|NCT00397007|"     The study aims to develop and to evaluate a psychophysiological intervention for distressing     chronic tinnitus. Therefore 100 people suffering from chronic tinnitus are randomly assigned     to either an intervention-group, receiving 12 sessions of a psychophysiological oriented     intervention, or to a waiting-list-group, who are waiting for a comparable time period.     Afterwards, patients of the waiting-list-group also receive intervention. The effects of the     intervention on severity, distress and perceived loudness of the tinnitus as well as on other     psychological variables like depression or self-efficacy are evaluated through comparing the     results of the intervention group with those of the waiting-list-group.      Additionally the psychophysiological reactivity under different stress-conditions is measured     before and after intervention or waiting. Therefore the activity of the muscles of head and     shoulders (EMG) as well as the skin temperature and skin conductance are measured. It is     hypothesized that patients with stronger psychophysiological reactivity benefit more from an     psychophysiological intervention.   "
195358|NCT00397020|"     The primary objective of this study is to compare the efficacy and tolerability of quetiapine     versus divalproex extended-release administered in a rapid oral loading fashion in the     treatment of acute episodes of mania or mixed mania in bipolar disorder. Three hypotheses     will be tested:      Hypothesis 1: treatment ( 3 weeks) of divalproex extended-release is similar to quetiapine in     the symptomatic control of mania or mixed mania      Hypothesis 2: divalproex extended-release orally loaded may produce significant improvements     in symptoms of mania sooner than quetiapine      Hypothesis 3: divalproex extended-release may produce significantly less sedation   "
195359|NCT00397033|"     The purpose of this study is to measure the effectiveness and assess the safety of two     dosages of the antipsychotic paliperidone extended-release (ER) in patients who are     experiencing an acute episode of schizoaffective disorder.   "
195360|NCT00397046|"     The purpose of this study is to assess the tolerability and safety of HKI-272, and to     determine the maximum dose that can safety be given. The secondary purpose of this study is     to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is     effective for the treatment of advanced solid tumors.   "
195361|NCT00397059|"     To study the impact of CYP2C19 polymorphism on escitalopram pharmacokinetics and     pharmacodynamics measured as changes in pupil diameter   "
195362|NCT00397072|"     The purpose of this single arm phase II study is to evaluate safety and efficacy of ZK 219477     in the treatment of temozolomide pre-treated, recurrent GBM patients.   "
195363|NCT00397098|"     The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID)     compared to placebo in the prevention of relapse of anxiety, in patients with Generalized     Anxiety Disorder improved after 12 weeks of treatment with SR58611A.      The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo     over a 24 to 52-week treatment period.      The secondary objective is to assess the safety and tolerability of SR58611A in patients with     GAD.   "
195551|NCT00407108|"     To investigate the feasibility and advantages of using perfluorocarbon liquid (PCL) perfusion     to remove vitreous during suction-cutting vitrectomy using a dual, dynamic drive     (3D)technology. In complicated surgeries in advanced diabetic retinopathy and retinal     detachment   "
195364|NCT00397111|"     This study is intended to help develop new MRI imaging techniques for studying mood and     anxiety disorders. Researchers believe that depression and anxiety disorders may cause     structural and functional changes in the brain. This study will optimize the way MRI scans     are collected to look at brain structure and examine how the brain behaves while subjects     perform particular tasks.      Healthy normal subjects between 18 and 50 years of age who have never had a major psychiatric     disorder and who have no first-degree relatives with mood disorders may be eligible for this     study. Candidates are screened by phone with questions about their psychiatric and medical     history, current emotional state and sleep pattern, and family history of psychiatric     disorders. Candidates who pass the preliminary screening then undergo additional screening     interviews and laboratory tests.      Participants undergo magnetic resonance imaging (MRI) and neuropsychological testing, as     follows:      <TAB>MRI scans: Subjects are asked to participate in an MRI study on one of several scanners     to measure blood flow in the brain, concentrations of certain chemicals in the brain, or     magnetic properties of the brain. MRI uses a strong magnet and radio waves to obtain pictures     of the brain. The subject lies still on a narrow bed with a metal coil close to the head. For     this study, subjects may be asked to wear a special coil on the neck to help measure blood     flow. They may be asked to watch a screen presenting images or to do a task in which they     respond to pictures or sounds and may be asked to return for additional scans.      <TAB>Neuropsychological testing: Subjects may undergo tests of cognitive performance. Often,     people with mood disorders have subtle changes in performance on these tests that allow     researchers to pinpoint where brain abnormalities occur. Before the tests can be used in     patients, they must be validated by using healthy subjects. These tests are presented either     orally, in written form, or on a computer.   "
195365|NCT00397124|"     the aim of this study is to measure brain metabolism in patients with lung cancer.FDG uptake     in the brain in patients with malignant tumors will be compared to the amount of tracer     activity found in patients who have benign pulmonary process. if differences between the     brain uptake of FDG in the two groups will be found, further assessment will be performed in     order to evaluate if such differences could be attributed and specifically localized to the     brain regions innervated by the vagus   "
195366|NCT00397137|"     The aim of this study is to determine the role of stapled anopexy in the treatment of     haemorrhoids by comparing it to the current gold standard treatment, which is excisional     haemorrhoidectomy.   "
195367|NCT00397150|"     The objective of the project is to develop and test an intervention to promote exclusive     breastfeeding (EBF), to assess its impact on infant health in African contexts where a high     prevalence of HIV is a barrier, and to strengthen the evidence base regarding the optimal     duration for EBF.      Promotion of EBF is the most effective child health intervention currently feasible for     implementation at the population level in low-income countries. It can lower infant mortality     by 13%, and by an additional 2% were it not for the fact that breastfeeding transmits HIV.     Only recently proven to be possible in hot and even dry climates, EBF without even offering     water is still little appreciated by mothers or supported by health workers. EBF rates are     especially low in Africa but the potential for rapid implementation may be high. A few     studies elsewhere suggest that peer counselling can often achieve dramatic increases. Thus     the investigators will run the first randomised trial to develop and test models for applying     this approach in four African countries and to quantify health benefits, cost-effectiveness,     and implications for the health care system.      While experts realize that the HIV threat ought not to present much of a biological     constraint to promoting EBF, in heavily affected countries it does represent a cultural     constraint. Overcoming this will require the development of a safe and effective means of     promoting EBF that is HIV-sensitive by taking into account the need to minimise postnatal HIV     transmission.      Another scientific constraint to the promotion of exclusive breastfeeding for six months, as     recommended by the World Health Organization (WHO), is uncertainty about its impact on the     micronutrient status of infants. In a substudy, the investigators will carefully follow     markers of infant micronutrient status to see how they vary by feeding pattern, including     EBF, for a longer period than has been examined previously.   "
195368|NCT00397163|"     During coronary artery bypass graft surgery, injury occurs to the heart muscle. Some of this     injury is due to the deprivation of oxygen and nutrients to the heart (a process called     ischemia) during the surgery itself. The objective of this study is to examine whether remote     ischaemic preconditioning (RIPC), in which the application of transient ischemia to the     forearm and thigh (through the inflation of blood pressure cuffs placed on the right upper     arm and upper thigh) may reduce the injury to the heart muscle sustained during cardiac     surgery.      The study hypothesis is: remote ischemic preconditioning will protect the heart and improve     short-term clinical outcomes during coronary artery bypass graft surgery.   "
195369|NCT00397176|"     Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release     (DVS SR) in healthy Japanese female subjects.   "
195370|NCT00397189|"     This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment     period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged     18-80 with melatonin deficiency.   "
195371|NCT00397202|"     1. Purpose: To compare the use of the menstrual cup The DivaCupTM  to a menstrual          strategy using tampons as the primary method of menstrual flow management using          indicators of user-satisfaction, urinary tract infection, vaginal irritation, cost and          waste.        2. Hypothesis: The The DivaCupTM will have similar rates of user-satisfaction, urinary          tract infection, and vaginal irritation as a menstrual strategy using tampons as the          primary method of menstrual flow management but will likely be more reasonable in terms          of cost and will generate less waste.   "
195372|NCT00397215|"     The present study is designed to evaluate the immunogenicity and safety of a single or double     dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a     two-administration schedule (21 days apart) in adults over 60 years of age. The persistence     of influenza antibodies will also be evaluated 24 months after vaccination.   "
195373|NCT00397228|"     After a screening evaluation including baseline clinical laboratory testing, a physical and     neurological evaluation, subjects will be asked to undergo an injection of ALTROPANE®     followed by up to 60 minutes of serial dynamic imaging. Subjects will undergo a second     injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging within 2-6     weeks of the injection 1.   "
195374|NCT00397241|"     The primary objective of this crossover trial is to compare the 3-month mean 24-hour     intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC)     given twice daily, versus latanoprost/timolol fixed combination (LTFC) given in the evening     and placebo given in the morning, versus adjunctive therapy with DTFC given twice daily and     latanoprost 0.005% given once in the evening in open-angle glaucoma patients who are     insufficiently controlled with latanoprost monotherapy.   "
195375|NCT00397254|"     The primary objective of this study is to evaluate a clinical limit (CL) of rizatriptan (9     rizatriptan 10mg Orally Disintegrating Tablet (ODT) per month) versus (vs.) a formulary limit     (FL) of rizatriptan (27 rizatriptan 10mg ODT per month) as measured by the number of days of     migraine per month.   "
195553|NCT00407134|"     Subjects with peritoneal dialysis are randomized to different groups. The different groups     receive different intra-abdominal volumes and different glucose-concentrations.      The effects on blood pressure and other cardiovascular parameters (e.g. central blood     pressure, augmentation index, ...) will be evaluated.   "
195376|NCT00397267|"     We assume that the combination of systemic steroids and inhaled steroid in the first hour of     treatment in the ER will decrease the admission rate and improve faster the pulmonary     function.      120 patients refferd to the ER due to asthma attack aged 18-60 with PFR < 60% 0o predicted     will participate in the study after giving informed consent.      The usual treatment in the ER is inhalation of Beta 2 short acting and I.V solumedrol 120 mg     . The study group will recieve in addition 3 inhalation of Budesonide 1000 microgram each     during the first hour.      The controlled group will recieve Nacl 0.9% PFR will be followed 0 30 60 120 min.   "
195377|NCT00397280|"     This study will investigate the response of immune cells (neutrophils, monocytes) to various     signals in the test tube to determine how they sense the signals in the body and what     substances they produce in response to them. It will determine how the cells may, under     certain circumstances, contribute to inflammation, and will measure substances in the blood     plasma (the liquid, non-cellular part of the blood) that might stimulate white blood cells,     in order to understand how the blood responds to possible disease-related conditions.      Healthy normal volunteers 18 years of age and older who weigh at least 110 pounds may be     eligible for this study. Participants give about 320 milliliters (mL) of blood (about 1 1/3     cups) or less at each donation. They donate no more than once every 8 weeks and no more than     six times a year. On some occasions, less than 320 mL of blood may be drawn. The collected     blood is separated into its components and specific cells are exposed to substances to     examine their response....   "
195378|NCT00397293|"     This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of     AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer   "
195379|NCT00397306|"     The purpose of this study is the evaluation of a bioimpedance method for determination of dry     weight in dialysis patients. Additionally normal tissue hydration in non-Dialysis patients is     investigated in healthy subjects and patients with chronic kidney disease in stages K/DIGO     I-IV   "
195380|NCT00397319|"     To evaluate specific markers of cardiovascular risk before and after growth hormone     replacement therapy in a population of growth hormone deficient adults, as compared to an     age, gender, and BMI-matched healthy population.   "
195381|NCT00397332|"     Alefacept (AMEVIVE®) is an immunosuppressive dimeric fusion protein that consists of the     extracellular CD2-binding portion of the human leukocyte function antigen-3 (LFA-3) linked to     the Fcof IgG1. Alefacept is produced by recombinant DNA technology in a Chinese Hamster Ovary     (CHO) mammalian cell expression system. It was shown to interfere with lymphocyte activation.     Alefacept was evaluated in two randomized, double-blind, placebo-controlled studies in adults     with chronic plaque psoriasis. Each course consisted of once-weekly administration for 12     weeks of placebo or alefacept. The response to alefacept was significantly better in both     studies. In both studies, onset of response to alefacept treatment (defined as at least 50%     reduction of baseline Psoriasis Area and Severity Index (PASI)) began 60 days after the start     of therapy. With one course of therapy, the median duration of response (defined as     maintenance of a 75% or greater reduction in PASI) was 3.5 months for alefacept treated     patients and 1 month for placebo-treated patients. Most patients who had responded to either     alefacept or placebo maintained a 50% or greater reduction in PASI through the 3-month     observation period.      Graft versus host disease (GVHD) is the most ominous side effect of allogenic stem cell     transplantation (SCT). It causes severe inflammatory process, which is usually located to the     skin, gut and liver. Treatment of GVHD consists of various immuno-suppressive and     immuno-modulating drugs, including steroids, cyclosporine, tacrolimus, methotrexate etc.     These drugs unfortunately can also cause severe immunologic failure that makes the patient     prone to infection and malignancy, and other medication-specific side effects. In spite of     this effect on the immune system, not all of the patients achieve control of GVHD, which     usually rapidly leads to death. Despite the use of innovative immunosuppressive modalities,     the prognosis of steroid resistant GVHD is usually poor. In the following study we will     evaluate the effect of alefacept on steroid unresponsive cGVHD.   "
195382|NCT00397345|"     The purpose of this study is to investigate whether TroVax, when added to first line standard     of care therapy, improves survival for patients with locally advanced or metastatic clear     cell renal adenocarcinoma.   "
195383|NCT00397358|"     This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.   "
195384|NCT00397384|"     This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when     given together with cetuximab and to see how well they work in treating patients with     advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or     colorectal cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Erlotinib hydrochloride and cetuximab may also stop the growth of tumor cells by blocking     blood flow to the tumor. Giving erlotinib hydrochloride together with cetuximab may kill more     tumor cells.   "
195385|NCT00397397|"     We wish to determine the best treatment for expulsion of lower ureteral stones. Which of the     three major treatment protocols is the best treatment of conservative management of ureteral     stones?   "
195386|NCT00397410|"     The aim of this study is to compliance with and effect of soft and hard hip protectors in     Norwegian nursing homes.   "
195387|NCT00397423|"     This study will examine the effectiveness of G-CSF in treating patients with amyotrophic     lateral sclerosis (ALS) - a fatal neurological degenerative disease that causes adult-onset,     progressive motor neurons loss in the spinal cord, brain stem and motor cortex. Patients     develop progressive wasting and weakness of both upper and lower limbs, bulbar and     respiratory muscles. Usually death from respiratory failure typically is within 3-5 years of     diagnosis. Although there are various treatments for ALS, riluzole is the only approved     treatment to delay the disease progression. G-CSF is an approved drug that is used to     increase white blood cell counts. Moreover, G-CSF and its receptor are expressed by neurons.     It acts anti-apoptosis by activating several protective pathways, stimulates neuronal     differentiation of adult neural stem cells in the brain, and improves long-term recovery.     G-CSF is a novel neurotrophic factor, and a highly attractive candidate for the treatment of     neurodegenerative conditions such as ALS.      Patients 18 to 65 years of age who have had mild to moderately severe ALS for 0.5 to 2 years     of duration may be eligible for this study. Candidates will be screened with a medical     history and possible review of medical records, physical examination, blood test, urine and     stool analyses, electrocardiogram, electrophysiological examination, neurological imaging     and, for women, a pregnancy test.      Participants will have drug therapy according to randomized number. One group receives G-CSF     while other group receives placebo. All of the participants receive riluzole treatment. For     the procedure, patients are given a medication to lessen anxiety and any discomfort. Patients     receive drug injections every 3 months for 5 days. The G-CSF dosage is 5μg/kg/day. Physical     examination and interview, Appel ALS scale and ALS-Functional Rating Scale will be done in     14, 28 days and 3, 6, 9, 12 months. Electrophysiological examination will be tested per 3     months. Blood samples will be collected on treat 5, 14, 28 days and 3, 6, 9, 12 months.   "
195554|NCT00407147|"     The purpose of this study is to test whether a U.S. Food and Drug Administration (FDA)     approved laboratory test (PCT Kryptor) can help doctors make better decisions on the need for     antibiotic therapy in ICU patients with suspected infections.   "
195388|NCT00404456|"     Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis     patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For     a good regulation of these circadian rhythms a uniform external synchronisation is necessary.     This is the synchronisation of the biological clock of our body by light and other     influences. In case of a disturbance of the external synchronisation, due to for example naps     during the day or wake periods at night, internal rhythms can be unlinked. As a result a     weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis     patients have sleep problems. Their sleep latency is prolonged. They often take a nap during     the day and their sleep efficiency is poor. There has only been one study on the melatonin     rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of     dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this     study no link was made between melatonin rhythm and the nature and severity of possible sleep     problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm,     exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal     biological clock and a better quality of life.      The aim is to research the endogenous melatonin rhythm and to improve sleep problems of     hemodialysis patients with a placebo-controlled study with exogenous melatonin. Next to this     a substudy is performed, in which the effect of the change of daytime to nocturnal in     hospital hemodialysis on sleep and melatonin is researched.   "
195389|NCT00404469|"     We will investigate the effect of peritendinous corticosteroid injections, eccentric training     and heavy resistance training in male patellar tendinopathy patients. The purpose is to     compare the clinical effect of these three treatments in a randomised controlled trial. Also     we wish to investigate the treatment mechanisms responsible for the effectiveness of the     three treatments.   "
195390|NCT00404482|"     Juvenile idiopathic arthritis (JIA) is often associated with chronic anterior uveitis.     Presence of vision threatening complications may indicate immunosuppressive therapy. In this     study, the experience with cyclosporine A (CsA) as mono- or combination-therapy is analyzed.   "
195391|NCT00404495|"     This study will assess the rate of objective confirmed tumor response of irinotecan in     combination with temozolomide in children with recurrent or refractory medulloblastoma and in     children with newly diagnosed high-grade glioma.   "
195392|NCT00404508|"     Chemotherapy resistance, either innate or acquired requires for its development, expression     changes on a large number of genes therefore, it has been hypothesized that     epigenetic-mediated changes could be the responsible driving force for chemotherapy     resistance. Aberrant DNA methylation and histone deacetylation are the main epigenetic     alterations hence, their reversal by inhibitors of DNA methylation and histone deacetylases     (HDACs) may overcome resistance in refractory solid tumors.      Patients will be treated with hydralazine and magnesium valproate starting from day -7 until     chemotherapy ends which consists on the same pre-study protocol regimen on which patients     progressed. Response and toxicity were evaluated. Global DNA methylation and HDAC activity     were evaluated in the peripheral blood cells, as well as the plasma levels of valproic acid     and hydralazine.   "
195393|NCT00404521|"     Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study.     The purpose is to determine the safety, tolerability and to identify the dose limiting     toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks,     intravenously, over 30 minutes to subjects with advanced malignant solid tumors.   "
195394|NCT00404534|"     A double-blind clinical trial investigating if a sub-group of functional dyspeptic patients     without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic     symptoms after Helicobacter eradication than the placebo control group   "
195395|NCT00404547|"     The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide)     compared with usual asthma care in the primary care setting. Patients with a history of     asthma for at least 6 months and who, in the opinion of the physician, meet the clinical     requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either     receive Alvesco® or usual care.   "
195396|NCT00404560|"     This screening study will examine the causes of immune disorders affecting white blood cells,     which defend against infections and will try to develop better means of diagnosis and     treatment of these immune disorders. This is a 2 visit screening study and patients     determined to be of interest for additional study or treatment will be asked to provide     consent for enrollment into an appropriate NIH follow up study. This study does not cover the     cost of the first visit to NIH for travel or lodgings but does cover the subsequent visit if     there is one. A financial assessment may determine if the patient is eligible for financial     assistance. This study does not enroll children under the age of 2.      Patients known to have or suspected of having increased susceptibility to infections and     their blood relatives may be eligible for this study, at the discretion of the principal     investigator. Patients and family members may undergo the following procedures:        -  Personal and family medical history.        -  Physical examination and blood and urine tests.        -  Studies of breathing function (pulmonary function testing)        -  Dental examination.        -  Eye examination.        -  Genetic Testing        -  Stored specimens for future analysis        -  Microscopic examination of saliva, wound drainage or tissues removed for medical reasons          for cell, hormone or DNA studies.      In addition, patients will be asked to obtain permission for investigators to obtain their     medical records, previous test results, or radiographic studies prior to the first visit.     Patients will be asked to undergo imaging studies, such as a chest X-ray, CT scan or MRI     scan.   "
195397|NCT00404573|"     This is a study designed to evalute the safety and efficacy of RGH-188 in the treatment of     acute schizophrenia. This study will be 10 weeks in duration; 6 weeks double-blind treatment,     and 4 weeks safety follow-up. All patients meeting the eligibility criteria will be     randomized to one of the three treatment groups--one of two doses of RGH-188 or placebo   "
195398|NCT00404586|"     This study was designed to look at safety aspects and effects of intranasal doses of     GW784568X on allergic rhinitis symptoms to develop this drug for its use in people who suffer     with allergic rhinitis   "
195399|NCT00404599|"     Background: HMG-CoA reductase inhibitors (statins) are effective lipid-lowering agents and     are known to reduce cardiovascular events. Beneficial effects of statins seem to occur very     early in the course of their therapy and subgroup analysis of large trials indicates that     subjects in statin-treated arms have less cardiovascular events than subjects in     placebo-controlled arm with comparable serum cholesterol levels. Therefore, it has been     suggested that statins may have antiatherogenic effects beyond their cholesterol lowering     effect. Many studies have demonstrated a rapid improvement in vascular function with     atorvastatine which cannot solely be accounted for by achieved lipid reduction. A rapid     oxidative stress lowering effect of atorvastatin has been proposed as the probable mechanism     of this action. Whether atorvastatine has stronger antioxidant effect and whether     atorvastatin lowers oxidative stress earlier in the course of therapy than other statins has     not been studied yet.      Objective: To compare the rapidity of onset and the extent of oxidative stress lowering of     atorvastatin with that of an (in terms of LDL lowering) equipotent dosage of simvastatin.      Methods: We plan to recruit sixty statin naive patients, with diabetes mellitus type 2 and/or     obesity (BMI > 25) and/or hypertension (RR>140/90 mmHg). Patients with K/DOQI stage 5 chronic     kidney disease (Cockcroft-Gault clearance of less than 15 ml/min/1.73m2), patients who use     any vitamin preparation, or statins in the last three months and patients with LDL     cholestrerol < 2.5 mmol/l will be excluded from the study. Because of the influence of     angiotensin-converting enzyme inhibitors (ACE-inhibitors) on oxidative stress, patients will     be stratified for prior ACE-inhibitor use during randomization. All included patients are     randomized to treatment with simvastatin 40 mg daily or atorvastatin 10 mg daily to achieve a     comparable lipid reduction. Established parameters of oxidative stress such as oxidized LDL,     malondealdehyde and isoprostane will be measured in plasma on inclusion, one week, six weeks     and three months after inclusion. We also plan to measure endothelial function parameters     such as soluble Vascular Adhesion Molecule (sVCAM) and von Willebrand factor. In addition,     parameters of inflammation such as high sensitive C - reactive protein, TNF-alfa,     interleukin-6 and myeloperoxidase will be measured to investigate whether there is any     correlation between oxidative stress lowering and endothelial function and inflammation. The     inhibitory effect of HDL to prevent oxidation of LDL will be determined by measurement of     lipid peroxides formed during in vitro oxidation of LDL co-incubated with HDL. The     inflammatory / anti-inflammatory properties of HDL will be tested by measurement of the HDL     capacity to inactivate oxidized palmitoyl-2-arachidonoyl-sn-glycero-3-phosphorylcholine     (ox-PAPC). Collections of 24 hours of urine at the beginning and after one week, six weeks     and three months will be used to measure urine F2-isoprostane levels.      Analyses: All parameters of oxidative stress before and during treatment with both statins     will be compared to determine whether atorvastatin causes a stronger and quicker reduction of     oxidative stress than simvastatin. Generalized estimating equations (GEE) will be used to     compare these effects. We plan to include a minimum of 30 patients in each treatment-group     from the outpatient clinic of the department of internal medicine of the VU University     Medical Center in Amsterdam.      Expected results: Atorvastatin will reduce oxidative parameters stronger and earlier than     simvastatin.   "
195400|NCT00404612|"     The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in     subjects with active non-infectious uveitis   "
195401|NCT00404625|"     To assess the molecular epidemiology, clinical impact, treatment outcome and risk factors for     infections caused by Enterobacteriaceae producing ESBLs in Italy in a large multicenter     observational survey.      SPECIFIC OBJECTIVES        1. To collect consecutive nonreplicate isolates of Enterobacteriaceae resistant to          expanded-spectrum cephalosporins from clinical specimens from inpatients and          outpatients.        2. To characterize the isolates for resistance phenotypes and for β-lactam resistance          mechanisms.        3. To investigate the clonality of isolates.        4. To analyse the epidemiology of various resistance mechanisms/resistant clones.        5. To collect clinical and epidemiological data for patients with infections caused by the          ESBL producers.        6. To analyse the epidemiology, risk factors and outcome for infections caused by ESBL          producers.   "
195402|NCT00404638|"     Several treatment modalities for children suffering from monosymptomathic nocturnal enuresis     are available including drugs, alarms, acupuncture, pelvic floor training and biofeedback.     The aim of this study is to to test if Paula Method (circular muscle exercise) can be an     another treatment modality.   "
195403|NCT00404651|"     The purpose of this trial is to clinically confirm that the manufacturing process of the     final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.      The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T     vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after     the three-dose primary series.      The secondary objectives are:        -  To describe in each group, the immunogenicity parameters for all antigens one month          after the third dose of the primary series        -  To assess the overall safety in each group one month after the third dose of the primary          series.   "
195404|NCT00404664|"     The purpose of this study was to see if reminder letters and a large raffle prize would     encourage health care workers to receive influenza vaccinations.   "
195405|NCT00404677|"     The loss of deep inhalation bronchoprotection in asthmatic individuals has been shown to be     related to the degree of airway hyperresponsiveness, a hallmark of asthma. In several     studies, asthmatic individuals with mild airway hyperresponsiveness (AHR) (methacholine PC20     > 2 mg/mL) had a difference in methacholine PC20 with and without deep inhalations that     averaged 1.8 doubling methacholine concentrations (p=0.0003). Conversely, asthmatic     individuals with moderate to severe AHR (methacholine PC20 ≤ 2 mg/mL) had a non-significant     difference in methacholine PC20 with and without deep inhalations (p=0.09). This loss of deep     inhalation bronchoprotection is also now believed to play an important role in the     pathogenesis of asthma. Airway inflammation is another of the key features of asthma and     information on airway inflammation is increasingly being used in the diagnosis and treatment     of asthma. The level of airway inflammation (as measured by fraction of exhaled nitric oxide     and sputum eosinophilia) has also been shown to be correlated to the level of airway     hyperresponsiveness (as measured by methacholine PC20). In addition, glucocorticoids have     been shown to decrease airway hyperresponsiveness, further suggesting that these two     phenomena, airway inflammation and airway hyperresponsiveness, are related. We therefore     suggest that the degree of airway inflammation is related to the loss of deep inhalation     bronchoprotection and expect there to be a negative correlation between the degree of deep     inhalation bronchoprotection and airway inflammation.   "
195406|NCT00404690|"     The hypothesis is that there is no difference between bedside silo placement and operative     closure in return of bowel function, ventilator dependence, or length of stay.      The primary outcome variable between the two techniques will be determined from this study     that can then be used to develop a definitive study. The likely variables will be length of     time to meet discharge criteria, length of hospitalization, time to full feedings, time on     mechanical ventilation and total hospital charges.   "
195407|NCT00404703|"     This single arm study will assess the feasibility of using Avastin plus platinum-based     chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or     recurrent squamous non-small cell lung cancer who have not received prior chemotherapy.     Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5     cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly     cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12     months. The anticipated time on study treatment is 3-12 months, and the target sample size is     <100 individuals.   "
195408|NCT00404716|"     Cilostazol is an kind of oral antiplatelet agent with a rapid onset of action that     selectively inhibits phosphodiesterase III, a mechanism different from adenosine diphosphate     (ADP) receptor antagonists. Previous studies had suggested that cilostazol has     lipid-modifying and vasodilating effects in addition to antiplatelet effects. From those     experimental and clinical backgrounds, we assumed that triple antiplatelet therapy with     aspirin, clopidogrel, and cilostazol might have a beneficial effect on the prevention of     atherothrombosis complications following coronary stenting. Therefore, we evaluated the     safety and efficacy of triple antiplatelet regimen of aspirin, clopidogrel and cilostazol     compared with dual antiplatelet regimen of aspirin and clopidogrel in patients with acute     coronary syndrome undergoing successful coronary artery stenting.      Patients undergoing successful coronary stenting were divided into dual antiplatelet therapy     (aspirin plus clopidogrel) and triple antiplatelet therapy (aspirin and clopidogrel plus     cilostazol) groups. All enrolled patients in triple regimen group will receive cilostazol     100mg, b.i.d., for 6 months in addition to standard dose and duration of aspirin and     clopidogrel for post-PCI. The primary endpoints included death, myocardial infarction, target     lesion revascularization, stent thrombosis within 30 days, binary restenosis at six month and     major adverse cardiac events (MACE) at one year. The secondary endpoints were side effects of     study drugs, including major bleeding, vascular complication, hypersensitivebility, and     bleeding complications. The study will be powered to test the hypothesis that triple     antiplatelet therapy is better than dual antiplatelet therapy.   "
195420|NCT00405379|"     Trabecular Metal(TM) is a relatively new technology and its use in knee replacement is quite     different from the more conventional total knee replacement (arthroplastie). The aim of     incorporating TMM into the material used for the knee replacement (tibial prostheses) is to     improve initial fixation of the prosthesis at the time of implantation (surgery) and to     improve long term prosthesis survival by encouraging and improving bone ingrowth.   "
195409|NCT00404729|"     In the management of glaucoma, as for as in other optic nerve diseases, an important goal of     ophthalmologists is represented by the possibility of influencing visual function.      In this regard, Parisi et al [Ophthalmology 1999; 106:1126-1134.] suggested the intramuscular     treatment with Cytidine-5-diphosphocholine (CDP-Choline or citicoline) to improve     glaucomatous visual defects. In particular, recent studies reported the effects of citicoline     on glaucomatous retinal and postretinal visual structures evaluated by electrophysiological     examinations (PERG and VEP). It was observed that a 2-month period of treatment with     citicoline may induce improvement in both ganglion cell function (PERGs with increase in     amplitudes and shortening in times-to-peak) and in neural conduction along postretinal visual     pathways (VEPs with increase in amplitudes and shortening in times-to-peak). The effects of     citicoline on glaucomatous retinal and postretinal structures were not present 8 months after     the end of treatment. However, performing several 2-month period of treatment with citicoline     during a total period of 8 years, it was found a additional improvement of the glaucomatous     retinal and postretinal impairment [Parisi V. Doc Ophthalmol. 2005 Jan;110:91-102). In this     work, we aimed to assess whether there similar visual function outcomes can be reached by the     oral treatment with citicoline in patients affected by glaucomatous optic nerve disease as of     as in other optic nerve diseases (i.e. non-arteritic ischemic optic neuropathy)   "
195410|NCT00404742|"     The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in     subjects with clinically quiescent non-infectious uveitis   "
195411|NCT00404755|"     This study will recruit 100 depressed patients to test whether the previous finding of an     association between treatment response (with treatment groups including placebo, imipramine,     and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also     found with a different type of commonly used anti-depressant, bupropion.   "
195412|NCT00404768|"     Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity     and mortality and is frequently associated with long-term disability. Oxytocin is a hormone     produced by the body during labor. GSK221149A is an experimental drug that will be used to     block the effects of oxytocin, and therefore pause or prevent contractions. In this study,     patients with preterm labor will be given an intravenous infusion of GSK221149A over     approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study,     patients with preterm labor will be give an intravenous infusion of GSK221149A over     approximately 48 hours. The use of a rescue tocolytic is allowed in the study.   "
195413|NCT00404781|"     Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary     intervention has been proven. However, patients with low response to those agents are     reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet     therapy for individual patients based on platelet function assay may improve long-term     outcomes especially in patients with high risk of thrombosis. In this prospective randomized     study, patients in control group all receive standard dual antiplatelet therapy, and patients     in optimized group receive different antiplatelet therapy according to risk stratification.   "
195414|NCT00405301|"     Purpose of the study is to evaluate the safety and efficacy of different re-introduction     regimens in anti-TB drug induced liver damage. There is no consensus how best to treat such     patients who developed drug induced liver damage.   "
195415|NCT00405314|"     The purpose of this study is to evaluate the effectiveness of continuous positive airway     pressure ventilation when applied by paramedics to individuals with severe breathing     difficulties in the prehospital setting.   "
195416|NCT00405327|"     Localized solid tumors such as, sarcoma, neuroblastoma, and Wilms' tumor, can generally be     effectively treated with a combination of surgery, radiation and chemotherapy. However,     patients with metastatic or relapsed disease have a very poor prognosis.      New approaches to the management of these difficult groups of patients are needed. There is     evidence to suggest that solid tumors may be good candidates for immunotherapy approaches. In     fact, recent experimental evidence indicates that the period of lymphopenia that occurs after     stem cell transplant may be an opportune time to use an immunotherapy treatment approach. In     light of the very poor prognosis of young patients with advanced solid tumors, this treatment     approach warrants further investigation.   "
195417|NCT00405340|"     Membranous glomerulopathy (MN) is still the most common glomerular disease associated with     nephrotic proteinuria (NS). Up to 40% of patients reach end stage renal failure (ESRD),     making MN the 2nd or 3rd most common cause of ESRD caused by a primary glomerulopathy.     Current treatment options include corticosteroids, alkylating agents, and cyclosporin, but     their use is controversial and the associated adverse effects and high cost temper their     usage. Experimental data in MN suggests that B cell activation results in immunoglobulin     deposition along the glomerular basement membrane causing injury to the membrane and     subsequent proteinuria. Drugs that non-selectively inhibit B cells and, these pathogenic     antibodies, are closely associated with improved outcomes. Based on the rationale that     selective depletion of B cells in humans would prevent the production of ?nephrotoxic?     immunoglobulins and subsequent renal injury we recently treated 15 patients with MN with     rituximab 1g i.v. twice (day 1 and day 15). Baseline proteinuria of 13.0±5.5g/24h decreased     to 9.1±7g, 9.7±8g and 6.5±6 g/24h at 3, 6, and 9 months, respectively (mean ± SD). Analysis     of the pharmacokinetic data obtained from this study, however, suggests that in heavily     nephrotic patients, rituximab dosed in this fashion results in patients being under-treated.     The present study propose to test the hypothesis that rituximab, given in accordance to the     standard lymphoma protocol (375mg/m2 x 4), will result in a more effective and profound     depletion of B cells, a more complete suppression of pathogenic antibodies, and a higher     remission rate of the NS while maintaining a favorable safety profile.   "
195418|NCT00405353|"     Since men are less likely to develop multiple sclerosis, the hypothesis was that testosterone     might be protective in MS. Men with MS for followed untreated for 6 months, followed by a 12     month treatment period with Androgel.   "
195419|NCT00405366|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed.      PURPOSE: This clinical trial is studying the side effects and how well sorafenib works in     treating patients undergoing surgery for stage II, stage III, or stage IV kidney cancer.   "
195421|NCT00405392|"     This is a randomized open label, multi-centre study for Korean women with postmenopausal     osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or     the once-weekly dosing of risedronate.      Eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly     regimen.      Treatment period consists of 3 month with ibandronate 150mg and additional 12 week with     risedronate 35 mg or vice versa.      After taking the first interventional medicine for 3 months or 12 weeks completely, a subject     changes the treatment arm. There is no washout period.   "
195422|NCT00405405|"     To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when     used with chemotherapy and radiation therapy in advanced head and neck cancer   "
195423|NCT00405418|"     Primary objective:      To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in     term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment     period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56     mg/dL (3.1 mmol/L)      Secondary objectives:        -  To compare between the 2 treatment groups, the percentage of patients who reach the          target of HbA1c < 7% and < 6.5% at the end of the treatment period        -  To compare the changes in HbA1c and fasting plasma glucose (FPG)        -  To compare the evolution of blood glucose profiles        -  To compare the day to day FPG variability, the insulin doses        -  To determine in each treatment group the biochemical and patient-related determinants of          failure to reach HbA1c targets        -  To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal          symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L)        -  To compare over the treatment period, the overall incidence and rate of symptomatic          hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL [3.9 mmol/L]),          of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of          severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL        -  To compare the overall safety: incidence of adverse events (including serious          hypoglycemia and local tolerance at injection site), change in body weight, in waist          circumference and in waist / hip ratio        -  To assess the quality of life and treatment satisfaction   "
195424|NCT00405431|"     The purpose of this study is to determine whether reducing inflammation of the surface of the     eye with topical Restasis after glaucoma surgery will improve surgical outcomes and increase     patient comfort.   "
195425|NCT00405444|"     The purpose of this study is to determine whether intranasal fentanyl is better than placebo     at decreasing pain in children 4-8 years of age during urinary catheterization for a VCUG     study.   "
195426|NCT00405457|"     To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial     Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI)     score and symptoms will be the same or lower than baseline after treatment in these patients.     The patients will tolerate the combination of Restasis® and Optive® with a low incidence of     clinical adverse events.   "
195427|NCT00405470|"     The purpose of this study is to determine whether this particular knee replacement is better     than those already on the market. By participation, it will further refine the design of     future total knee replacements and perhaps increase longevity.   "
195428|NCT00405483|"     The purpose of this study is to determine if MIS for primary hip replacement surgery     increases the risk of long term aseptic loosening as predicted by implant micromotion     detected by radiostereometric analysis.   "
195429|NCT00405496|"     The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is     effective in the treatment of uveitis.   "
195430|NCT00405509|"     This study examines the cold processes of children aged 6 to less than 14. Children will be     seen by the study staff 6 days in a row during the course of their naturally-acquired colds.     Nasal secretions will be examined for chemicals that the body creates during a cold. Skin     cells will be collected by brushing the inside of the child's cheek with a small brush. The     cells will be examined for genes that may hold control the creation of these chemicals.   "
195431|NCT00405522|"     The objective of this study is to compare intraoperative and recovery parameters in patients     who receive two different dose combinations of propofol and remifentanil in patients     undergoing a lumbar puncture.   "
195432|NCT00405535|"     The purpose of this study is to determine whether individuals with obsessive compulsive     disorder who will take a preparation of the amino acid glycine in addition to their current     treatment, may experience improvement in their symptoms.   "
195433|NCT00405548|"     The purpose of this research study is to evaluate the effects of cardiac hormone replacement     with SQ (subcutaneous or under the skin) injection of BNP (brain natriuretic peptide, a     hormone produced by the heart) on the pumping ability of the heart, kidney function and     levels of different hormones in the blood in response to an intravenous salt solution.   "
195434|NCT00405561|"     The purpose of the study is to evaluate efficacy and safety of AMT2003 in cancer patients     with advanced colorectal carcinoma.      The primary endpoint is progression free survival rate at 18 weeks after registration   "
195435|NCT00405574|"     This is a multicenter, randomized, phase II study of the safety and efficacy of two dose     levels of oral ATN-224 in patients with prostate cancer with a rising serum PSA in the     absence of detectable disease. Patients will be randomized (1:1) after confirmation of     eligibility requirements. The primary endpoint is to determine the proportion of patients who     do not have PSA progression for 24 weeks. PSA progression is defined as at least a 50%     increase in PSA and >5 ng/mL from baseline or post-treatment nadir if lower than baseline,     confirmed by another PSA at least 28 days later.   "
195436|NCT00405587|"     The primary objective of this FIH study is to assess the safety and pharmacokinetics of     PLX4032 in patients with solid tumors. The secondary objective is to assess the     pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant     melanoma who have the V600E BRAF oncogenic mutation.   "
195437|NCT00405600|"     The goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable     spine joints. A patient may or may not receive rods and screws with the use of bone graft     materials to facilitate bone growth and a fusion thus preventing movement of the bones of the     spine.      In this research study, bone graft substitute material called Bone Morphogenetic Protein-2     known as BMP-2 Infuse will be used. No hip bone will be used. The surgical procedure will     consist of BMP-2 Infuse with or without the use of rods and screws.   "
195440|NCT00405639|"     The following are done for screening procedures to determine if patients are eligible for     this study: blood count, kidney and liver blood tests. Patients will complete a 6-minute walk     test. Patients will be instructed to follow a no-added-salt diet for 1-3 weeks before the     study and for the whole duration of the study. Diet instructions will be given to the patient     and the patient will collect his/her urine for 24 hours before the active study day. Patients     will need to avoid strenuous exercise and abstain from smoking, alcohol, and caffeine for 3     days prior to the study days. Patients will remain on their regular medications.   "
195441|NCT00405652|"     Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in     gastrointestinal (GI) complications in some patients. This study will assess if a switch from     MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or     health-related quality of life in liver transplant recipients   "
195442|NCT00405665|"     The objective of this trial is to determine the safety and effect on pulmonary function of 14     days of inhaled L-arginine versus placebo administered over a period of 14 days in a cohort     of CF patients.   "
195443|NCT00405678|"     To determine the effects of endurance exercise training on cardiopulmonary fitness in breast     cancer patients undergoing neoadjuvant chemotherapy.   "
195444|NCT00405691|"     The purpose of this multi-center, randomized, clinical study is to establish the safety and     effectiveness of the TOPS™ System, used following decompression, in the treatment of lower     back and leg pain with, or without spinal claudication, that results from moderate or severe     lumbar spinal stenosis at one vertebral level between L3 and L5.   "
195445|NCT00405704|"     In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with     vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic     urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ)     prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal     scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial     resistance.   "
195446|NCT00405717|"     Clopidogrel and statins are frequently coadministered in patients with ischemic heart     diseases. Recent reports suggested that clopidogrel's effectiveness in inhibiting adenosine     diphosphate (ADP)-induced platelets aggregation is attenuated by co-administration of certain     statins. The objective of the present study is to define which kind of statins might     interfere with the antiaggregation property of clopidogrel in patients with acute coronary     Syndrome after percutaneous coronary intervention (PCI).      In this prospective randomized study, all patients in test group will receive clopidogrel     plus atorvastatin, and all patients in control group will receive clopidogrel plus     pravastatin. All patients will be followed up for one year. The primary endpoints include     death, non fatal AMI, urgent revascularization. The secondary endpoints include hemorrhage     events and subacute thrombosis events at 1 year.   "
195447|NCT00405730|"     To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to     Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment     of ocular inflammation and ocular pain after cataract extraction with IOL implantation   "
195448|NCT00405743|"     Patients with refractory or relapsed hematologic malignancies will receive CP-4055     intravenously(IV) on Day 1-5 every three weeks until complete response or disease     worsening/progressing   "
195449|NCT00405756|"     The purpose of this study is to determine whether lenalidomide is safe and effective in the     treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older.   "
195450|NCT00405769|"     This study will attempt to further validate a clinical treatment plan to lower LDL values     using non-prescription supplements combined with a lifestyle change and education program     which could represent an alternative approach to improve compliance in group of people who     are unable to take traditional medication to lower cholesterol.   "
195451|NCT00405782|"     This study is being done to evaluate the impact of moderate-intensity exercise (such as     walking) on quality of life, energy level, endurance and mood in women with metastatic breast     cancer. Studies have shown that women with early stage breast cancer who exercise during     treatment have more energy, less sleep disturbance, less anxiety and depression, and better     strength and endurance than women who do not exercise. These studies have also shown that     women who exercised during treatment for early stage breast cancer did not develop injuries     or increased fatigue from exercising during chemotherapy and radiation treatments. The     investigators are conducting this trial to see if women with metastatic breast cancer     experience similar benefits from exercise as women with earlier breast cancer. The     investigators also wish to determine whether women with advanced disease are able to exercise     safely during their treatment under the supervision of an exercise physiologist.   "
195452|NCT00405795|"     This observational study will acquire initial clinical practice utilization and product     safety data for the Envision® surface.   "
195453|NCT00405808|"     Primary objective:      To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting     Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of     12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with     impaired fasting blood glucose and with or without associated comorbidities.      Main Secondary objectives:      To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist     circumference (WC), body weight, glycemic parameters and lipid parameters.      To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.   "
195462|NCT00405925|"     Antiretroviral naïve patients with <350 xE6/l CD4 cells and a HIV-viral load of > 30.000     cop/ml are started on combivir ® and Kaletra ®. When patients have reached an undetectable     viral load of< 50 cop/ml on two consecutive occasions at least at week 12, but no later than     week 24, they are randomised in either continuation with Combivir/Kaletra or switch to     Trizivir ® twice daily one pill during 96 weeks. All patients randomised in the     combivir/Kaletra arm are eligible to switch to Trizivir at any post randomisation visit when     they reach predefined switch criteria for elevated levels of fasting glucose or lipids.   "
195463|NCT00405938|"     This is a phase II trial combining bevacizumab with either fulvestrant or anastrozole with     trastuzumab in the treatment of metastatic breast cancer in postmenopausal women. It is hoped     that these combinations will keep the cancer from growing and spreading further.   "
195454|NCT00405821|"     This study will determine whether acyclovir, a medicine used to treat herpes simplex virus 2     (HSV-2), can slow down the progression (worsening) of HIV disease in people with both HIV and     HSV-2 infections. HSV-2 increases the amount of HIV virus in the blood of infected people and     may make HIV progress faster. The study will evaluate:      Whether people who take acyclovir can avoid antiretroviral treatment until later in their     lives      Whether people who take acyclovir get fewer genital ulcers      How well people are able to take acyclovir and any side effects they experience from it      Differences in the amount of HIV virus in the blood of patients who are and are not taking     acyclovir, and how HIV/AIDS is different in these patients.      People 18 years of age and older living in the Rakai district of Uganda who are infected with     both HIV (early stage disease) and HSV-2 may be eligible for this study. Participants are     randomly assigned to take the study drug, acyclovir, or a placebo (look-alike pill with no     active ingredient) daily for 2 years. During this time, they visit the clinic once a month     for a routine physical examination. Patients who develop genital ulcers or complications of     HIV are treated for the problem, and patients whose HIV disease progresses, requiring them to     begin antiretroviral therapy, are treated accordingly.   "
195455|NCT00405834|"     This study is to evaluate the clinical safety and effectiveness of the Envision® surface.   "
195456|NCT00405847|"     The purpose of this study is to assess the short-term effect of sympatholysis on sleep     quality and inflammation in critically ill patients.   "
195457|NCT00405860|"     Microscopic polyangiitis (MP) is a primary systemic vasculitis predominantly affecting small     blood vessels. Following the widespread introduction of ANCA testing, the primary systemic     vasculitis (SV), Wegener?s granulomatosis (WG) and microscopic polyangiitis (MP) appear to be     more frequent than was previously thought (see definitions in Appendix 6). In addition, the     existence of early and organ-limited forms of these diseases, such as renal-limited     vasculitis (RLV) is now clearly recognized. Their annual incidence exceeds 20 per million per     year and they account for at least 5 % of the causes of end stage renal failure. The two     diseases share many features of their histology, serology and response to treatment, pointing     to similarities in their pathogenesis, which have justified a common approach to their     management. The standard treatment with corticosteroids (CS) and cyclophosphamide (CYC) is     usually effective at controlling active disease but continued treatment is necessary to     prevent disease relapse. Due to the cumulative toxicity associated with CYC treatment,     alternatives have been looked for. Mycophenolate mofetil (MMF) has been used to treat     patients with a variety of immune-mediated nephritides, including ANCA-associated vasculitis,     with less toxicity than CYC but with variable outcome. The present trial will examine whether     substitution of oral CYC with oral MMF is equally efficient for induction of remission with     less adverse effects in cases of MP with mild to moderate renal involvement. All patients     will receive the same regimen of oral prednisone + MMF. Prednisone will be tapered to a stop     after 24 weeks but MMF will continue for a total of 18 months unless there is worsening or     persistent disease. The trial ends after 18 months.   "
195458|NCT00405873|"     The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer     patients with advanced primary hepatocellular carcinoma      The primary endpoint is best overall response rate within 20 weeks after registration   "
195459|NCT00405886|"     Tinnitus is commonly referred to as ringing of the ears - the perception of sounds in the     absence of an external source of acoustic signals. Tinnitus may represent a severe disease     and symptoms include depression, sleeping difficulties, decreased sound tolerance and hearing     loss. One hypothesis is that tinnitus is caused by an increased activity of NMDA glutamate     and dysfunctional alpha9/alpha10 acetylcholine receptors in the inner ear and central nervous     system. Neramexane may alleviate tinnitus symptoms due to its NMDA and alpha9/alpha10 nACh     receptor blocking activity. The purpose of this study is to assess the safety and efficacy of     Neramexane compared with placebo in patients with subjective tinnitus.   "
195460|NCT00405899|"     The objective of this study is to determine whether there is a relationship between     interferon-gamma levels and the incidence of viral respiratory infections in allergic     children treated with allergy immunotherapy as compared to those treated with standard     medical care (nasal steroids, antihistamines) over a 1-year period. The hypotheses to be     tested are 1) interferon-gamma levels will be significantly increased 3, 6, 9 and 12 months     in allergic children treated with allergy immunotherapy as compared to those treated with     standard medical care, 2) the incidence of viral respiratory infections will be reduced at 3,     6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to     those treated with standard medical care.   "
195461|NCT00405912|"     After a steady decline for the last 50 years, the prevalence of tobacco use in the United     States has reached a plateau of approximately 23%. Currently available treatments among     adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need     to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult     tobacco use prevalence.      Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central     synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant,     St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating     mild to moderate depression. SJW is well tolerated, available over the counter, and is     significantly less expensive than the established treatments for tobacco dependence.      To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of     tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing     tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind,     placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants     (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week     course of SJW 900 mg per day, 1800 mg per day, or a matching placebo.      This study is anticipated to provide the data needed to develop a larger randomized     controlled clinical trial submitted through the R01 funding mechanism.   "
195529|NCT00406822|"     The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective     and safe to implant as an aid of glaucoma surgery.   "
195530|NCT00406835|"     The purpose of this study is to determine if WBRT combined with SRS resulted in improvements     in survival, brain tumor control, functional preservation rate, and frequency of neurologic     death.   "
195464|NCT00405951|"     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow     unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process     of cell death that is often inhibited in cancer cells.      This is a multi-center, open-label, Phase I/II study of obatoclax administered in combination     with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung     Cancer. Treatment may be administered on an outpatient basis. No investigation or commercial     agents or therapies other than those described herein may be administered with the intent to     treat the patient's malignancy. Supportive care measures including those directed at     controlling symptoms resulting from Non-Small Cell Lung Cancer are allowed.   "
195465|NCT00405964|"     This study will investigate the effectiveness of desloratadine in treating subjects with     allergic rhinitis who meet the criteria for persistent allergic rhinitis (PER)   "
195466|NCT00405977|"     The aim of this study is to investigate whether an optimized pre-treatment with intravenous     magnesium enhances the speed of onset of a standard intubation dose of rocuronium.   "
195467|NCT00405990|"     The study aims to invite male sexual partners to attend antenatal clinic with their pregnant     partners to either acquire pregnancy information or undergo voluntary counselling and testing     for HIV. To see if male sexual partner involvement will decrease sexual risk behaviour.   "
195468|NCT00406003|"     The study was designed to describe the relationship between dose and pharmacokinetic     parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR     tablet (12.5 to 37.5 mg) as well as safety profile   "
195469|NCT00406016|"     This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of     6 dose regimens of ATI355 in acute spinal cord injury patients   "
195470|NCT00406029|"     The purpose of the study is to assess the efficacy and safety of a range of doses of SCH     420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase     inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2     mg, and 5 mg taken twice a day) of preladenant with placebo (sugar pill). Following an     Interim Analysis (temporary hold for new enrollment-ongoing subjects will continue on     treatment) to review drug safety, a new dose group of 10 mg (taken twice a day) may be added.      Approximately 160 participants will be randomized in this study in approximately 22 study     centers worldwide for the first part of this study. Following the Interim Analysis, 40 new     participants may be added, for a total of 200 participants. The study is double blind, which     means neither you nor your study doctor will know whether you are receiving the study     medication or placebo.   "
195471|NCT00406042|"     To evaluate whether or not using topical steroids after selective laser trabeculoplasty     affects intraocular pressure outcomes.   "
195472|NCT00406055|"     The purposes of this study is to 1) Provide additional information that the commercially     available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used     successfully by a wide range of physicians under commercial use conditions. 2) Provide an     ongoing post-market surveillance mechanism for documentation of clinical outcomes and for     possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a     broader group of patients.   "
195473|NCT00406068|"     The purpose of this study is to determine the efficacy and safety of intravesical     Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional     cell carcinoma (papillary tumors and/or carcinoma in situ) of the urinary bladder at high     risk of progression who are refractory to therapy with bacillus Calmette-Guerin (BCG).   "
195474|NCT00406081|"     Atopic dermatitis (AD) causes people to be susceptible to skin infection and inflammations.     The purpose of this study is to determine the immune response to chicken pox vaccine in     children with or without AD who received the vaccine 2 to 16 weeks prior to the study visit.   "
195475|NCT00406094|"     The purpose of this trial is to determine if patients with NARES treated with montelukast     (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils.   "
195476|NCT00406107|"     The purpose of this study is to evaluate the effect of intravitreal injections of Macugen     every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion     (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that     chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.   "
195477|NCT00406120|"     Up to half of patients with ocular melanoma (also called iris, choroidal or uveal melanoma)     develop metastasis. We have found that certain molecular features of the eye tumor can be     detected by gene expression profiling and accurately predict which patients will develop     metastasis. This molecular test could eventually allow high risk patients to receive     preventative therapy to delay or prevent the development of metastasis. The goal of this     study is to prospectively validate the predictive accuracy of the gene expression-based     molecular test and compare it to monosomy 3, the most common but potentially less accurate     molecular marker for metastasis in ocular melanoma.   "
195478|NCT00406133|"     Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0%     in 3 age groups (>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring     (CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A     parallel randomized trial is being conducted for a second cohort with HbA1c <7.0% that will     follow an identical protocol to that of the first cohort with HbA1c >=7.0%.      The >=7.0% trial was specifically designed and statistically powered to compare separately     the impact of continuous versus standard intensive glucose monitoring in the three age     groups. Both trials used standardized treatment algorithms and equivalent frequent contacts     with subjects in both the CGM and control group.      After completion of the 26-week trial, the CGM group continues to use CGM for another 26     weeks to evaluate whether any beneficial effect seen in the first 6 months is sustained with     longer-term use and less intensive contact and the control group initiates CGM use with less     intensive contact after the first month than was provided at initiation of CGM use in the CGM     group in the randomized trial.   "
195555|NCT00407160|"     Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin     induction and triple drug maintenance using Tacrolimus, mycophenolate, and steroids.   "
195479|NCT00406146|"     Artemisinin combination therapies (ACT) are currently recommended for malaria treatment.     Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly     adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial     treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date.     Moreover, the safety of repeated treatments with ACT has been little studied. This study aims     to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of     these regimens in a longitudinal trial in which recruited children will be followed up for 1     year.   "
195480|NCT00406159|"     PURPOSE      The purpose of this investigation is to evaluate the cognitive and behavioral effects of     Hyperbaric Oxygenation Therapy in children who present with a diagnosis of autism spectrum     disorder.      HYPOTHESIS        1. Hyperbaric Oxygenation Therapy will be safe to use with children with autism.        2. Hyperbaric Oxygenation Therapy will have a statistically significant effect on the          symptoms of autism.        3. Hyperbaric Oxygenation Therapy will have a clinically significant observable effect on          the overt symptoms of autism.        4. The decreases in the symptoms of autism will correlate positively with the number of          Hyperbaric Oxygenation Therapy sessions.        5. Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at          follow-up, post 40 treatment sessions.      SPECIFIC AIMS        1. Provide further evidence for the safety of Hyperbaric Oxygenation Therapy in children          with autism.        2. To quantitatively assess the effects of Hyperbaric Oxygenation Therapy on behavioral and          cognitive symptoms of autism before, during, and after treatment.        3. Identify number of treatments required to reach therapeutic effects.        4. Identify the length and durability of treatment effect and maintenance.   "
195481|NCT00406172|"     To report safety and efficacy of intravitreal injection of bevacizumab in patients with     cystoid macular edema secondary to cataract surgery.   "
195482|NCT00406185|"     The purpose of the registry is to collect and analyze clinical and laboratory data and tissue     samples from patients who are diagnosed with any type of heart disease and to collect the     same information and samples from healthy controls in participating Intermountain Healthcare     facilities.   "
195483|NCT00406198|"     The impact of continuous veno-venous haemofiltration (CVVH) on sepsis-induced multiple organ     failure severity is controversial. We thus sought to assess the effect of early application     of haemofiltration on the degree of organ dysfunction and plasma cytokine levels in patients     with severe sepsis or septic shock.   "
195484|NCT00406211|"     Follow-up to evaluate the immunogenicity and safety of three production lots of GSK     Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second     year of life, as compared to separate administration of GSK Biologicals'     measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany &     Austria. Blood samples were collected at three time points during the follow-up period (Year     1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.   "
195485|NCT00406224|"     Background It has recently been shown that diffuse luminance flicker increases retinal and     optic nerve head blood flow. This indicates that a neuro-vascular coupling between neural     activity and blood flow exists as described previously for the brain. Although a lot of     mediators such as NO, pO2, pCO2, H+ and K+ have been proposed, the mechanism of this coupling     is still a matter of controversy. However, it has been shown in an animal experiment, that an     increase in blood flow, evoked by diffuse luminance flicker stimulation is paralleled by an     decrease in pO2 in the tissue. Thus, in this study we set out to investigate the flicker     light induced increase in blood flow under elevated blood pO2.      Study rationale The motive for the investigation of retinal blood flow regulation is to     enhance our understanding of the coupling mechanism between increased neural activity and     blood flow in the retina in order to gain new insight in the pathophysiology of several eye     diseases associated with ocular vascular disorders Study objectives To test the hypothesis     whether oxygen breathing influences flicker light induced changes in optic nerve head blood     flow   "
195486|NCT00406237|"     Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with     primary biliary cirrhosis (PBC)   "
195487|NCT00406250|"     The purpose of this study is to investigate the safety and efficacy of intravitreal     bevacizumab in patients with choroidal neovascularization associated with angioid streaks.   "
195488|NCT00406263|"     Progression of nuclear sclerotic cataract after pars plana vitrectomy has been recognized for     many years The mechanism for the rapid progression of nuclear sclerotic cataract remains     unclear. The objective of this trial is to evaluate and compare the level and progression of     cataract advancement in controls versus eyes that have undergone 20-gauge pars plana     vitrectomy and 25-gauge pars plana vitrectomy.   "
195489|NCT00406276|"     This is an open-label, single-arm, Phase I/II trial to determine the safety of RAD001 in     combination with docetaxel and compare the efficacy of RAD001 plus docetaxel versus published     Phase II and III reports of docetaxel alone in patients with recurrent NSCLC.   "
195490|NCT00406289|"     This study will evaluate the feasibility of higher and prolonged dose escalation concentrated     in the intra-tumoral regions which are FDG-avid after two weeks of radiotherapy.   "
195491|NCT00406302|"     Primary objective is to assess the overall response rate (ORR) after induction therapy with     docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and     IIIa. ORR will be determined by the percentage of patients achieving objective response rates     (CR + PR) according to the RECIST guidelines.   "
195492|NCT00406315|"     The primary objective of this study is to evaluate change in weight as a result of switching     from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder     who have failed to achieve a satisfactory clinical response to quetiapine due to lack of     efficacy or poor tolerability.   "
195493|NCT00406341|"     The purpose of this phase 3 study is to determine if difluprednate ophthalmic emulsion is     effective in the treatment of postoperative inflammation.   "
195552|NCT00407121|"     Intravitreal injection of Bevacizumab in patients with Neovascular Membranes secondary to     intraocular inflammation. We injected a single injection of Bevacizumab (2.5 mg/0.1 ml) and     evaluate visual acuity , Fluorescein angiogram and retinal thickness by Optical Coherence     Tomography (OCT) in 4 patients with Vogt Koyanagi Harada disease, 1 patient with Serpiginous     Choroidopathy and 1 patient with Multifocal Choroiditis.   "
195494|NCT00406354|"     A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to     compare the efficacy and safety of atomoxetine versus placebo in children and adolescents     aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid     oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an     initial 3- to 28-day screening and washout phase, participants will be assigned to     double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be     succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will     be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.   "
195495|NCT00406367|"     Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline.     Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to     five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.   "
195496|NCT00406380|"     Evaluation of efficacy of Intravitreal Injection of Bevacizumab in patients with Yuxtafoveal     Telangiectasias   "
195497|NCT00406393|"     The study is designed as a phase III, randomized, open label, multicenter, prospective,     comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as     graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched,     related, peripheral blood stem cell transplantation in individuals with hematologic cancer.     Participants will be stratified by transplant center and will be randomly assigned to the     sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.   "
195498|NCT00406406|"     Safety and tolerability of SKI-606 in healthy subjects; the influence of food intake on the     same.   "
195499|NCT00406419|"     This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in     combination with methotrexate in patients with active rheumatoid arthritis who have had an     inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of     intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of     i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg -     25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment     is 1-2 years. Target sample size is 1000.   "
195500|NCT00406432|"     The study was designed to assess the steady-state pharmacokinetic profile of paroxetine after     14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy     Chinese subjects.   "
195501|NCT00406445|"     This study will examine metabolic and biological factors in people with Li-Fraumeni syndrome,     a rare hereditary disorder that greatly increases a person's susceptibility to cancer.     Patients have a mutation in the p53 tumor suppressor gene, which normally helps control cell     growth. This gene may control metabolism as well as cancer susceptibility, and the study     findings may help improve our understanding of not only cancer but also other conditions,     such as cardiovascular function.      Healthy normal volunteers and patients with the Li-Fraumeni syndrome and their family members     may be eligible for this study. Candidates must be at least 18 years of age, in overall good     health and cancer-free within 1 year of entering the study. Participants undergo the     following procedures:        -  Blood tests for routine lab values and for research purposes.        -  ECG and echocardiogram (heart ultrasound) to evaluate heart structure and function.        -  Resting and exercise metabolic stress testing: The subject first relaxes in a chair          wearing the facemask and then exercises on a stationary bicycle or treadmill while          wearing the mask. This test uses the facemask to measure oxygen usage by the body to          determine metabolic fitness. Electrodes are placed on the body to monitor the heart in          an identical manner to a standard exercise stress test.        -  Magnetic resonance imaging of metabolism: The subject lies on a bed that slides into a          large magnet (the MRI scanner) for up to 60 minutes. During scanning, the arm or leg          muscles are stressed by inflating a blood pressure cuff and by exercising the limb for          several minutes. Subjects may be asked to squeeze a rubber ball or exercise with a foot          pedal. Immediately afterwards, the pressure in the cuff is released and remains deflated          for 10 to 15 minutes. No more than three 5-minute episodes of blood flow stoppage are          performed.        -  Standard MRI scan of exercised limb to determine muscle volume.        -  Brachial artery reactivity test to measure blood vessel function: Before the exercise          stress testing, subjects lie on a stretcher while the brachial artery (artery in the          forearm) is imaged using a noninvasive ultrasound method. Artery size and blood flow          velocity are measured before and after inflating a blood pressure cuff on the forearm.          Vessel size and flow velocity measurements are repeated after 15 minutes and again after          administration of nitroglycerin under the tongue.        -  Oral glucose tolerance testing to test for diabetes: To assess sugar metabolism,          subjects drink a sugar solution. Blood samples are collected before drinking the          solution and 1 and 2 hours after drinking the solution.        -  Muscle biopsy (optional according to subject preference): Subjects may be given small          amounts of sedation for the procedure. A small area of skin over a leg muscle is numbed          and a small amount of muscle tissue is surgically removed.   "
195502|NCT00406458|"     The purpose of the study is to study the clinical effects of the investigational drug, SB-509     versus placebo in patients with diabetic neuropathy.   "
195503|NCT00406471|"     The RAVE (Rubeosis Anit-VEgf) trial, utilizes monthly intravitreal Ranibizumab (Lucentis)     injections for 9 months to see if total VEGF blockade will prevent neovascular glaucoma and     eliminate the need for panretinal photocoagulation in patients with ischemic central retinal     vein occlusion.   "
195504|NCT00406484|"     A randomized clinical trial to compare the efficacy of Behavioral Drug and HIV Risk Reduction     Counseling (BDRC) and standard methadone drug counseling.   "
195505|NCT00406497|"     The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is     effective in the treatment of postoperative inflammation.   "
195506|NCT00406510|"     The purpose of this study is subjectively compare duration of action between Optive and     Systane.   "
195507|NCT00406523|"     Janus stent is the only marketed drug-eluting stent (DES) without polymer coating as yet in     China. The goal of this study is to evaluate the efficacy of JANUS (Tacrolimus eluted stent)     in inhibiting of restenosis in percutaneous coronary intervention (PCI) real world and to     observe the safety and efficacy of 4 months’clopidogrel treatment after implantation of JANUS     stent.      Patients were enrolled and randomized to be treated by JANUS or SRNCRO (bare metal stent with     the same platform as JANUS). All enrolled patients received daily clopidogrel for 4 months     and aspirin for life long for post-PCI period(In AMI group, patients received daily     clopidogrel 150mg for 2 weeks at first). The primary endpoints included death of heart,     myocardial infarction, revascularization of the target lesson, sub-acute and late stent     thrombosis one year after PCI, The secondary endpoints included MACE at 30 days, 6 months and     restenosis by follow-up angiogram at 6 to 12 months.   "
195508|NCT00406536|"     The purpose of this phase II research study is to evaluate the effectiveness of the next     generation LYM-X-SORB™ in improving the essential fatty acid (EFA) and choline status for     children and adolescents with Cystic Fibrosis (CF) and pancreatic insufficiency (PI).   "
195509|NCT00406549|"     To establish the clinical test performance characteristics of sensitivity, specificity and     predictive values for direct detection of nasal Staphylococcus aureus colonization against     clinical microbiology laboratory culture methods.   "
195510|NCT00406562|"     This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals'     dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.   "
195511|NCT00406575|"     Two doses of relaxin will be compared to placebo for the treatment of patients with     decompensated CHF   "
195512|NCT00406588|"     This study is a multicenter, randomized, double blind, parallel group study of 3 months'     treatment with SLV308 administered as a monotherapy in patients with advance stage PD. An     open label safety extension to this study is planned as a separate protocol for patients who     are willing and eligible to participate.   "
195513|NCT00406601|"     The aim of this study (*) is to evaluate the progression free survival rate at 6 months,     response rate, overall disease control rate, overall survival of BAY-43-9006 in soft tissue     sarcoma patients.      (*) as per Protocol Amendment No. 1 of 16 April 2007 approved by local IEC on 24 July 2007   "
195514|NCT00406614|"     Many Korean Americans are at risk for developing high blood pressure. Low health literacy     levels may play a role in this risk. The purpose of this study is to evaluate a     literacy-focused program aimed at reducing blood pressure levels in older Korean Americans.   "
195531|NCT00406848|"     The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once     daily to placebo on depression in elderly patients (greater than or equal to 65 years of     age). Patients who do not respond in the first 13 weeks will be eligible for rescue using     pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria     will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue     criteria will be assigned to duloxetine 60 mg/day.   "
195515|NCT00406627|"     The purpose of this study is to check blood samples for lymphatic filariasis to determine     whether the recent Program to Eliminate Lymphatic Filariasis was successful in controlling     lymphatic filariasis in areas of Egypt. Volunteers will participate in a health assessment     program carried out by Ain Shams University and approved by the Egyptian Ministry of Health     and Population. This program includes a brief interview and laboratory tests to detect worm     parasites in participants' blood. Volunteers and family members found to have worms in their     blood will be referred for treatment. This study will provide early detection of this     parasitic infection and referral for prompt treatment in order to prevent spread of the     infection to others. Approximately 23,500 people, 6 years of age and older, will participate     per year. Study participants will include people living in areas of Egypt that are known to     have the filariasis parasite. Volunteers will participate for up to 2 years.   "
195516|NCT00406640|"     Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine     reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability     of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are     postmenopausal.   "
195517|NCT00406653|"     The purpose of this clinical research study is to learn if abatacept can improve signs and     symptoms of active Crohn's Disease in patients who have not had an adequate response to other     therapies. The safety of this treatment will also be studied.   "
195518|NCT00406679|"     The aim of the study is to evaluate the therapeutic efficacy and safety of two different     paracetamol-containing solutions in postoperative dental pain. They will be compared to     placebo (a dummy treatment which contains no active ingredient).   "
195519|NCT00406692|"     In this study the influence of zonisamide administration over a 13 week period on alcohol     consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of     zonisamide given to subjects will be slowly increased over a period of several weeks. They     will receive a full dose over a 5 week period. This will be a pilot study in which all of the     subjects will only receive zonisamide. A primary objective of this study is to determine the     possible size of the effect that zonisamide administration has on drinking (i.e. drinks     consumed per day) to allow us to plan for a larger clinical trial of the effects of     zonisamide on alcohol dependence.   "
195520|NCT00406705|"     The purpose of this study is to examine whether breathing helium-hyperoxia during exercise in     a pulmonary rehabilitation program can improve the exercise tolerance and health related     quality of life of patients with Chronic Obstructive Pulmonary Disease (COPD).   "
195521|NCT00406718|"     This study will determine the comparative effectiveness of two systems designed to improve     medication adherence in people with schizophrenia.   "
195522|NCT00406731|"     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in     perfusion pressure. The existence of an effective autoregulation in the optic nerve     circulation has been shown in animals and humans. The exact mechanism behind this     autoregulation is still unknown. The motive for the investigation of optic nerve head (ONH)     blood flow autoregulation is to enhance the understanding of pathologic eye conditions     associated with ocular vascular disorders. To clarify the regulatory mechanisms of ONH     microcirculation is of critical importance to understand the pathophysiology of glaucoma     because there is evidence that glaucoma is associated with optic nerve head ischemia. Several     studies indicate that a disturbed autoregulation might contribute to glaucomatous optic     neuropathy. Previous findings suggest endothelial dysfunction in glaucomatous optic     neuropathy, in particular alterations in endothelin- and nitric oxide- system, which both     play an important role in local regulation of vascular tone.      In the present study, changes in ocular perfusion pressure will be performed during     administration of drugs, which may potentially alter the pressure-flow relationship. These     drugs include endothelin-1 and the nitric oxide synthase inhibitor NG-monomethyl-L-arginine     (L-NMMA).   "
195523|NCT00406744|"     Choroidal neovascularization is a leading cause of visual loss in people older than 60 years     and for its treatment there had been performed multicentric studies with Lucentis     (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated     efficacy of bevacizumab in several pathologies but we dont know what would be the results if     we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab     for improve or stabilize visual acuity with two or more intravitreal inyections of     bevacizumab.   "
195524|NCT00406757|"     In Japan, patients with relapsed or refractory T-ALL/T-LBL represent an extremely small     patient population. While the small number of patients presents a practical limitation to the     size of a clinical trial, patients whose disease has not responded to or has relapsed after     treatment with multiple prior chemotherapy regimens have no accepted standard therapies     available. Japanese leukemia experts have expressed interest in evaluating 506U78 in Japanese     patients with relapsed or refractory T-ALL/T-LBL. In order to obtain safety, tolerability,     and pharmacokinetic data of 506U78 in Japanese patients, this study is designed to maximize     the contribution of each available patient.   "
195525|NCT00406770|"     The study investigates whether bright artificial light adds to hypocaloric diet to lose     weight in obese subjects.   "
195526|NCT00406783|"     This study will investigate the effectiveness of desloratadine in treating subjects with     allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.   "
195527|NCT00406796|"     The purpose of this study is to determine whether ranibizumab will be effective in reducing     if not eliminating the macular edema associated with the disease, central retinal vein     occlusion (CRVO).   "
195528|NCT00406809|"     The Phase 1 portion of the study evaluated the pharmacokinetic profile and safety of ABT-263     with the objective of defining the dose limiting toxicity and maximum tolerated dose in     subjects with lymphoid malignancies. The Phase 2a portion of the study is evaluating ABT-263     using a step-up dosing regimen and may be increased to the defined recommended Phase 2 dose     to obtain additional safety information and a preliminary assessment of efficacy in subject     with lymphoid malignancies. The Extension portion of the study is to allow Phase 2a subjects     who remain active 1 year after the last subject enrolls or who have been on study     approximately 1 year to continue receiving ABT-263 with less frequent study evaluations.     Subjects in the Extension Study will continue receiving study drug for up to 7 years after     the last subject transitions to the Extension Study, or until disease progression or toxicity     that necessitates discontinuation (whichever comes first).   "
195532|NCT00406861|"     Objective of the trial is to assess the safety and efficacy of Montelukast in treatment of     Erythema Nodosum leprosum (ENL) reaction in multibacillary leprosy patients either in     combination with prednisolone or alone.      Hypothesis is that montelukast will reduce the severity of ENL reaction in Multibacillary     leprosy patients without causing an unacceptably high incidence of adverse effects.      Design is a multicentre hospital-based single-blind prospective trial for leprosy patients     with ENL reaction. prior written consent will be taken from the patients who will undergo the     trial.      Endpoints are decrease in severity of ENL and absence of new nerve function impairment   "
195533|NCT00406874|"     This study compares the effects of omega 3 fats plus folic acid with placebo plus folic acid     on sperm quality and sexual function in infertile men. It will also evaluate the effects on     sexual fuction of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo in subjects     continuing on both omega 3 fats and folic acid.   "
195534|NCT00406887|"     The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic     emulsion is effective in the treatment of treatment of uveitis.   "
195535|NCT00406900|"     Uveal Melanoma is the most common primary intraocular tumor in adults. Most tumors     metastasize to the liver. So far no sensitive or specific serological tumor marker is     routinely used. The marker Melanoma inhibitory activity is a promising marker. Study     hypothesis is to detect metastatic lesions in an early stage. This would increase life     expectance of our patients   "
195536|NCT00406913|"     The purpose of this study is to evaluate the conjunctival flora prior to cataract or     vitrectomy surgery comparing mupirocin ointment applied to the conjunctiva along with     standard ocular sterilization vs. standard ocular sterilization alone.   "
195537|NCT00406926|"     This study investigated the effect of growth hormone on the growth of infants and toddlers     with Turner syndrome during 2 years of treatment with growth hormone. This was compared with     the growth of infants and toddlers with Turner syndrome who did not receive any growth     hormone treatment. The overall aim was to prevent the growth failure usually seen during this     period. The study also looked at middle ear disease, hearing problems, and cognitive and     behavioral development.   "
195538|NCT00406939|"     This study is designed to determine the safety of IL-12 gene therapy for patients with     recurrence of prostate cancer after radiation therapy and those with or without metastatic     disease with a prostate gland intact. These, of course, would include recurrent prostate     cancer after definitive radiation therapy. The prostate cancer will be treated with a     prostatic injection of a replication-defective adenovirus vector delivering the IL-12 gene.     Following virus injection, patients will be hospitalized for 23 hours for observation. Only     one course of therapy will be administered. Each patient will be carefully monitored for     toxic effects. Three to five patients will be tested with a low dose of virus and if there     are no serious adverse side effects, the dose will be slowly escalated in subsequent groups     of 3-5 patients or until unacceptable toxicity is reached. Effectiveness will be monitored by     serum prostate-specific antigen (PSA), transrectal ultrasound of the prostate, prostate     biopsy and comparison of survival times to historical survival times for patients with     radiation recurrent prostate tumors. The primary objective of this initial study is to     determine whether the treatment is associated with significant toxicity.   "
195539|NCT00406952|"     Purpose of the study is to evaluate use of electronic diaries and voice acoustics for use in     future depression clinical trial. Focus is on increased precision of measurement.   "
195540|NCT00406965|"     This is a Phase II, multicenter, randomized, double blind, placebo controlled, multiple-dose     study designed to evaluate the efficacy, safety, and tolerability of subcutaneously     administered HAE1 in subjects 12-75 years old with moderate to severe asthma whose symptoms     are inadequately controlled with moderate to high-dose ICS and LABA.   "
195541|NCT00406978|"     This study will evaluate the safety and the efficacy of the association of Melphalan/     Prednisone/Thalidomide/Defibrotide (MPTD) as salvage treatment in advanced and refractory     myeloma patients. This association might further increase the response rate achieved by oral     MPT regimen   "
195542|NCT00406991|"     The project aims to find mechanisms for the abnormal retinal blood flow that in diabetic     patients often precedes any evidence of clinical retinopathy and may contribute to the     development of retinopathy.      Specifically, the projects tests the hypothesis that reduced retinal blood flow found in     young patients with type 1 diabetes reflects increased resistance in the small vessels of the     retina caused by the formation of small blood clots, called microthrombi; and that     antiplatelet agents normalize the reduced retinal blood flow.   "
195543|NCT00407004|"     This trial compares the efficacy of two artificial liver support systems, MARS (Molecular     Adsorbents Recirculating System) and Prometheus (FPSA, Fractionated Plasma Separation and     Adsorption), in removing albumin-bound substances such as bilirubin, bile acids, and     cytokines.   "
195544|NCT00407017|"     The purpose of this study is to compare patient outcomes in following cataract surgery in     patients randomized to one of two surgical kits.   "
195545|NCT00407030|"     At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all     patients who entered the extension period were treated with up to five injection sessions of     incobotulinumtoxinA (Xeomin) during the extension period.   "
195546|NCT00407043|"     To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry     eye.      It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the     stinging with cyclosporine administration and the dry eye signs and symptoms experienced     during the initiation of therapy.   "
195547|NCT00407056|"     The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic     emulsion is effective in the treatment of severe uveitis.   "
195548|NCT00407069|"     Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by recurrent     viral skin infections. Recent studies have demonstrated that the skin of people with AD my     have decreased antimicrobial peptide (AMP) expression. The purpose of this study is to     compare smallpox virus replication and the number of AMPs and other antiviral molecules in     people with AD, as compared to those seen in people with psoriasis or asthma, or healthy     individuals.   "
195556|NCT00407173|"     This study is an open-label, single-dose, parallel group study to evaluate the effects of age     and gender on the pharmacokinetics, safety, and tolerability of HCV-796 administered orally     to healthy subjects.   "
195558|NCT00407199|"     This is a pilot study that will focus on the collection of preliminary data to determine the     efficacy of quetiapine for individuals with social phobia. We hypothesize that individuals     will react with less self-reported anxiety and physiological reactivity in the drug condition     than in the placebo condition. If true, this would constitute a strong signal for a     significant treatment effect for quetiapine in social phobia. A positive treatment effect in     this study would provide rationale for further investigation of the efficacy of quetiapine     for cue reactivity for individuals with social phobia. Further study would include increased     sample size in order to obtain statistical power and replication of findings. We will utilize     the IR formulation of quetiapine.   "
195559|NCT00407212|"     This study will investigate the effect of TCH346 compared to placebo in delaying the need for     symptomatic treatment with dopaminergic agents   "
195560|NCT00407225|"     The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is     effective in the treatment of postoperative inflammation.   "
195561|NCT00407238|"     The purpose of this study is to evaluate the effect on epithelial barrier function of three     emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during     normal regimen use.   "
195562|NCT00407251|"     The purpose of this study is to determine the efficacy of patupilone chemotherapy and to find     out what effects (good and bad) the drug Patupilone has on patients with prostate cancer that     has progressed following hormone treatment and docetaxel chemotherapy.   "
195563|NCT00407264|"     The purpose of this study is to assess the efficacy of fluticasone on the development of lung     cancer in smokers   "
195564|NCT00407277|"     Cigarette smoking decreases life expectancy, causes devastating health complications, and     costs society billions of dollars each year. These untoward consequences are especially     pronounced among persons with schizophrenia (SCZ) because approximately 80% to 95% of this     group smokes cigarettes. These high prevalence rates underscore the need for research     investigating the determinants of smoking in patients with SCZ. Several researchers have     observed that nicotine improves specific symptoms of SCZ including negative symptoms,     negative affect, and cognitive deficits. This has led to the hypothesis that patients with     SCZ smoke in an attempt to self-medicate. However, the mechanism(s) by which nicotine has its     positive effect on symptoms remains unclear. The current proposal posits that neural     inhibition (NI) is a physiological mechanism of this effect, while variation in the     alpha-7-nicotinic receptor subunit gene (CHRNA7) represents the genetic underpinnings of     these processes. The proposed study will assess NI and symptom improvement after acute     administration of nicotine to both smokers and nonsmokers with SCZ. In addition, NI and     CHRNA7 variation will be tested as predictors of patients' ability to reduce/quit smoking     following smoking treatment. These data may lead to the development of new pharmacological     strategies for treating the symptoms of SCZ and new methods for assisting these patients to     quit smoking.   "
195565|NCT00407290|"     Perineal pain after childbirth occurs in the majority of women (with or without episiotomy).     Perineal pain can become source of chronic pain in 9%-12% of the cases. Neostigmine a     cholinesterase inhibitor at a dose of 500µg combined with Sufentanil or Ropivacaine (=local     anaesthetic) is an analgesic. The goal of this study is to examine the effect of the use of     epidural Neostigmine for perineal analgesia at the end of the labor on acute pain and on the     development of chronic pain post partum.   "
195566|NCT00407303|"     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow     unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process     of cell death that is often inhibited in cancer cells.   "
195567|NCT00407316|"     The purpose of this study was to measure the quality of visual function and quality of daily     living in patients with anterior, posterior, and panuveitis.   "
195568|NCT00407329|"     We hypothesize that the absolute or relative serum or urine levels of the urokinase     plasminogen activator system, including uPA, uPAR and PAI-1,2 (inhibitors of the uPAR/uPA     complex), are associated with inflammation in prostatic tissue.   "
195569|NCT00407342|"     Alefacept is a new anti-psoriatic drug within the group of the so-called biologics. In about     30% of patients alefacept induces a more than 75% improvement of psoriasis after a 12-week     treatment period. The start of anti-psoriatic effect by alefacept is delayed, however     improvement of psoriatic lesions outlasts the end of alefacept treatment.      Narrowband UVB (UVB-311nm) phototherapy is an established anti-psoriatic treatment regimen     with rapid onset of anti-psoriatic efficacy but disease-free intervals after the end of     successful treatment courses may be short.      Therefore, in this half-side (left/right side) comparison study we aim to investigate whether     an additional narrowband UVB treatment accelerates and improves the anti-psoriatic treatment     effects of alefacept.   "
195570|NCT00407355|"     Central and branch retinal vein occlusions are major causes of visual loss. Hemorrhage and     capillary nonperfusion, when they involve the macula, can contribute to visual loss, but the     major cause is macular edema. Focal and grid laser photocoagulation can sometimes provide     benefit in patients with macular edema due to branch vein occlusions, but several laser     treatments are often needed and recovery of vision can be very slow and incomplete 1. Laser     photocoagulation does not provide benefit for macular edema due to central vein occlusions 2.     Therefore, new treatments are needed.The objective of this study is to assess the bioactivity     of 3 intravitreous injections 0.5 mg or 0.3 mg of ranibizumab in patients with macular edema     due to central and branch retinal vein occlusions and correlate activity with peak and trough     aqueous levels. The purpose of this research protocol is pilot study to determine if a     randomized placebo controlled trial is warranted.   "
195587|NCT00407576|"     Alzheimer's disease is associated with accumulation in the brain of a protein called amyloid.     The purpose of this study is to test the ability of a research drug to measure amyloid in     brain using positron emission tomography (PET) and a research drug called [11C]MeS-IMPY.   "
195588|NCT00407589|"     This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in     participants with bacterial conjunctivitis. The purpose of this study is to determine the     extent of systemic exposure to BOL-303224-A following single and multiple topical     administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.   "
195571|NCT00407368|"     The purpose of this study is to perform a prospective evaluation regarding the relationship     between platelets function and cardiovascular events in patients with ESRD.      The study will include 100-200 patients with ESRD, age 18 years or older, treated in the     nephrology division of Assaf Harofeh medical center.      The primary end points of the study are cardiovascular events including acute myocardial     infarction (defined as symptoms + acute elevation of TnI), need for coronary artery disease     revascularization, or acute cerebrovascular event (TIA or CVA) and mortality. The secondary     end points are any hospitalization due to acute coronary syndrome, active bleeding with the     need for blood transfusion and dialysis access graft thrombosis (time to thrombosis).      Blood will be taken for complete blood count including platelets count and mean platelets     volume, serum electrolytes, albumin, blood lipids, Kt/V, troponin and two 5 ml aliquots from     each blood collection will be separated and stored at -70co until analyzed for oxidative     stress, homocysteine and highly sensitive CRP will be performed. Five mL of blood will be     sent for platelets function assessment.      During the follow up period the correlation between platelets function an cardiovascular     events will be assessed.   "
195572|NCT00407381|"     This study is being done to see if the investigational drug Ranibizumab (RBZ) given by     injection into the eye, is safe and effective to use in people with diabetic macular edema     (DME). The investigators want to compare RBZ to laser treatment which is the current standard     way to treat DME.      RBZ blocks a growth factor that is thought to be involved in the formation of abnormal blood     vessels that cause loss of vision in patients with DME.   "
195573|NCT00407394|"     Background: The current Integrated management of childhood infections (IMCI) algorithm     prescribes that children with wheeze and fast breathing presenting to first level health     facilities are given antibiotics if they continue to have fast breathing after two doses of     bronchodilator. The primary purpose of the algorithm is to prevent mortality due to bacterial     pneumonia. However, an unknown proportion of children managed in this fashion will have a     viral related wheezing illness or asthma rather than pneumonia. Although it is unlikely that     wheezing syndromes are a significant cause of mortality for children in developing countries,     these algorithms are likely to result in unnecessary administration of antibiotics as well as     inadequate treatment of recurrent wheezing illness. We do not have clear evidence about     whether antibiotics can be withheld in some categories of children with wheeze. It is clear     that wheeze can occur in bacterial infection and in addition co-infection with virus and     bacteria has been well demonstrated in several studies of pneumonia etiology in children.     Although some studies have found that children with more severe disease or who are blood     culture positive are more likely to be febrile at presentation, this sign is not sufficiently     sensitive or specific to determine whether antibiotics should be administeredSetting: The     study will be conducted in eight medical colleges situated in Lucknow, Nagpur, New Delhi,     Mumbai, Chennai, Trivandrum, Vellore, and Chandigarh. Design: This will be a multicentric,     randomized, double blind efficacy trial. . Hypothesis: The primary hypothesis is that the use     of oral amoxycillin for three days would be as effective, in terms of clinical cure on day 4     as compared to use of oral placeboMain objective: To compare the proportion of children aged     2 to 59 months presenting with non-severe pneumonia with wheeze whose respiratory rate does     not fall below the age specific cut-off after three doses of nebulized salbutamol, that     achieve clinical cure on day 4 on 3 day of treatment with oral amoxycillin versus     placebo.Inclusion criteria: Children aged 2-59 months with non-severe pneumonia based on WHO     criteria of respiratory rate above the age specific cut-off, audible / ausculatory wheeze.     Exclusion criteria: Children with severe disease, received any documented antibiotic     treatment in the past 48 hours, diagnosed asthmatic on maintenance therapy, complicating     acute non-pulmonary or chronic illness, known drug allergy, hospitalization in the past 2     weeks, history of measles within the last month, known immunodeficiency disorder, prior     enrollment in the study, residing in areas not accessible for follow-up or whose guardian     refuses to consent for the study. Sample size: Has been calculated to test the null     hypothesis. There will be 950 children in each arm. Thus each site is required to recruit a     minimum of 225 cases over 18 months.   "
195574|NCT00407407|"     The primary purpose of this study is to determine the maximum tolerated dose and     dose-limiting toxicities (DLTs) of weekly and every 3-weeks ABI-007 in combination with     carboplatin (area under the curve [AUC]=6) in patients with ovarian cancer, primary     peritoneal cancer, or fallopian tube cancer.   "
195575|NCT00407420|"     We run a successful clinic in Bristol for children with severe obesity who already     demonstrate many features to suggest they are at increased risk of early diabetes and heart     disease. However, we have found that young children respond better to simple interventions     than do adolescents. We have used a new treatment regimen Mandometer® to help our most     difficult adolescent cases lose weight. We would like to do a study to see if all adolescents     might improve weight loss using this technology compared to what we routinely offer   "
195576|NCT00407433|"     These are Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in     refractory or relapsing pediatric solid tumors.   "
195577|NCT00407446|"     To test the hypothesis that long-term PDE5-inhibition by overexpressing the nitric oxide     pathway is beneficial in chronic heart failure patients.      Double-blind and placebo-controlled trial. Primary end-points: quality of life and exercise     performance   "
195578|NCT00407459|"     The primary objective is to assess antitumor activity of the combination of bevacizumab,     pemetrexed and carboplatin, in terms of time to progression.   "
195579|NCT00407472|"     This study was a Phase I, open label, randomized, 2-period, 2-sequence, crossover study     designed to assess the relative bioavailability of Saizen administered by the ATS-1     needle-free injection device and a standard needle and syringe. Informed consent was obtained     prior to screening. All screening assessments establishing subject eligibility were performed     in the 21 days before dosing. Randomization Pre-dose on Day 1, subjects were randomized to     one of the two treatment sequences: Sequence 1: SC Saizen administered by the Standard needle     and syringe (Period 1) followed by the administration using the ATS-1 device (Period 2).     Sequence 2: SC Saizen administered by the ATS-1 device (Period 1) followed by administration     using the standard needle and syringe (Period 2).      Subjects were resident at the Unit from approximately 19:00 on Day -1 until Day 2     (approximately 30 hours (h) post dose) of each treatment period. An IV Stilamin infusion was     commenced 1 h before. Saizen administration and stopped immediately after the last     pharmacokinetic (PK) blood sample has been taken, i.e. a 25 h infusion. Stilamin was     administered as a constant IV infusion at a rate of approximately 118 mg/h (40 mL/h), which     corresponds to 1.65 mg/kg body weight/h for a person weighing 70kg. Dosing with Saizen     occurred between approximately 0800 and 0900 h on Day 1 of each treatment period after an     overnight fast of at least 10h. Subjects were dosed with Saizen at the same time on Day 1 in     Periods 1 and 2. There was a minimum of 7-day washout between treatment periods 1 and 2.      Laboratory safety tests, ECGs were taken at protocol specified time points and blood samples     for the assessment of glucose and growth hormone were taken immediately predose and 1, 2, 3,     4 4.5, 5, 5.5, 6, 7, 8, 12, 18 and 24 h post dose. A post-study visit took place 33+/- 3 days     after dosing a treatment period 2.   "
195580|NCT00407485|"     This phase II trial is studying the side effects and how well VEGF Trap works in treating     patients with recurrent, locally advanced, or metastatic cancer of the urothelium. VEGF Trap     may stop the growth of tumor cells by blocking blood flow to the tumor.   "
195581|NCT00407498|"     P276-00 is specific Cdk4-D1 and Cdk1-B inhibitor. P276-00 exhibited significant tumour     reduction in animal models with less adverse effects.Based on the results from various     in-vitro studies, P276-00 could be a potential candidate as a new mechanism based drug for     the treatment of cancer.This Phase I study will determine the Maximum Tolerated Dose,Dose     Limiting Toxicity and efficacy of P 276-00 in patients with advanced Refractory neoplasms.   "
195582|NCT00407511|"     Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic     neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy     induced peripheral neuropathy.   "
195583|NCT00407524|"     This study aims to provide scientific evidence of the efficacy and safety of this agent as     'add-on' therapy for adult patients whose asthma remains uncontrolled on standard medication.     The aims are to assess the efficacy, safety and tolerability of AKL 1 companred to placebo in     the treatment of asthma.   "
195584|NCT00407537|"     To investigate whether a Caduet based treatment strategy might result in greater reduction in     total cardiovascular risk as compared to usual care in subjects with hypertension and     additional risk factors.   "
195585|NCT00407550|"     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving pemetrexed disodium together with gemcitabine may kill more tumor     cells.      PURPOSE: This randomized phase II trial is studying two different schedules of pemetrexed     disodium and gemcitabine to compare how well they work in treating patients with stage IIIB     or stage IV non-small cell lung cancer.   "
195586|NCT00407563|"     The purpose of this study is to evaluate the effectiveness and tolerability of the     combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian     cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life     is during their treatment.   "
195590|NCT00407615|"     This project is to assess the effectiveness of the use of magnets in reducing chronic lumbar     pain. I understand that I will wear a flex pad (magnet) during waking hours and keep daily     Visual Analog Scale (VAS) pain scores to determine if wearing this device will reduce my     constant pain. I understand that there are no adverse side effects known from the use of     these magnets other than irritation at the site. The identical inactive pads (sham/placebo)     have been supplied for use as controls.      I will be randomly assigned into one of two groups and I agree to remain blinded as to the     specific type of device that I will receive, i.e. active vs. placebo. Dr. Weintraub     (principal investigator) will remain blinded throughout the study. I also agree to not break     the blind. Dr. Weintraub has stated that as a result of my cooperation and ability to     complete the study, I will be guaranteed to either keep my specific device or receive a     specific known active device gratis. This currently sells commercially for $60.   "
195591|NCT00407628|"     To investigate the relationship between the integrity of the white matter, including the     corticospinal tracts and the corpus callosum, with the recovery of lower extremity function     in patients with cerebral stroke at the subacute and chronic stages.   "
195592|NCT00407641|"     Low molecular weight heparin (LMWH) provides a safe and effective alternative to UFH for     hemodialysis anticoagulation. While unfractionated (UF) heparin has been implicated in     hyper-lipidemia, the effect of LMWHs on the lipid profile in non-diabetic patients on chronic     hemodialysis remains controversial. The effect of LMWH in diabetic patients, a high risk     group for developing hyper-lipidemia and cardio-vascular disease, has not been studied.      The study intends to examine the long-term effects of the replacement of UFH by LMWH     (tinzaparin sodium) on cardio-vascular outcomes and on lipoprotein profiles in a large group     of diabetic patients stable on HD.   "
195593|NCT00407654|"     This phase II trial is studying how well VEGF Trap works in treating patients with previously     treated metastatic colorectal cancer. VEGF Trap may stop the growth of colorectal cancer by     blocking blood flow to the tumor.   "
195594|NCT00407667|"     Transcranial galvanic stimulation (tDCS) seems to promote motor recovery after stroke by     stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment     of severe arm paresis after stroke, robot-assisted arm training (AT) proved to be effective,     but nevertheless only a few patients could use their affected hand functionally in daily life     after robot training. Therefore the present study intends to combine both approaches, tDCS +     AT, applied at the same time every day for six weeks. The study has three treatment arms, two     groups will receive the tDCS, either anodal of the lesioned or cathodal of the non-lesioned     hemisphere. The anodal stimulation is expected to facilitate the activity of the arm motor     area of the lesioned side directly, while the cathodal stimulation of the non-lesioned     hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory     inputs. The third group will receive a sham-stimulation. All patients will work with the AT     simultaneously to the tDCS, respectively sham-tDCS.   "
195595|NCT00407680|"     To observe the effect of intensive medical treatment for type 2 diabetic patients with     hypertension: to discover whether or not intensive medical treatment improves proteinuria,     and the difference between the clinical meaning of responder and non-responder (criteria: 50%     reduced proteinuria continuing 6 months or more during the observation period.)   "
195596|NCT00407693|"     In this study we will examine where the radioactive tracer [11C]PBR28 is distributed in the     body of healthy volunteers to calculate the radiation exposure to organs of the body. We will     also test if [11C]PBR28 binds to your blood cells and compare with the binding in PET images.   "
195597|NCT00407706|"     In our previous research, we have shown that women that have breast cancer have a population     of lymphocytes that recognizes specific antigen and there cytoplasmic matrix goes through     physical change a short time after exposure in vitro to the same antigen. This change can be     measured by polarization changes of fluorescent light emitted by FDA (fluorescein diacetate)     labeled cells. Further test that we performed showed that those differences are also shown in     a benign situation that known as indicator for a high risk for developing breast cancer     within 10-15 years. The incidence of the expression of these lymphocytes correlates with the     histopathological picture as it is related in high risk for the developing the disease.      In this work we will expand the scope of the procedure to early detection of the cancerous     process in breast lesions by Fitzgibbon's risk categories for the development invasive     carcinoma of the breast. In the proposed work we intend to use specific antigen MUC1 for     breast cancer. This study is a continuation of our published work in the The Breast    "
195598|NCT00407719|"     The purpose of this study is to see if the drug bevacizumab is safe and effective to use for     people with choroidal neovascularization (CNV). CNV is an eye condition where abnormal blood     vessels grow in the part of the eye responsible for central (straight ahead) vision. The drug     is produced using recombinant DNA technology and has been approved by the FDA for use in     colon cancer. Although not yet approved for people with CNV, the FDA has given permission to     use this drug in this study.   "
195599|NCT00407732|"     The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that     will assist patients with hepatitis C in overcoming barriers that prevent them from becoming     appropriate candidates for interferon therapy.   "
195600|NCT00407745|"     The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with     spinal cord injury compared to placebo (pill that contains no active medicine). This study     will also evaluate the safety of pregabalin in this patient population.   "
195601|NCT00407758|"     RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with     persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.   "
195633|NCT00400361|"     This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in     patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma     or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending     doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of     1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a     satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose.     The anticipated time on study treatment is until disease progression or dose-limiting     toxicity, and the target sample size is <100 individuals.   "
195602|NCT00407771|"     -  The purpose of this study is to examine the effects of tirofiban on platelet function          the Ultegra RPFA in diabetic patients undergoing elective coronary angioplasty and          stenting already treated with high loading dose (600mg) clopidogrel.        -  About 44 people will be in the study. The study duration is a single hospitalization          period during which the angioplasty will be performed in addition to a 30-day post          hospitalization follow-up period.        -  Patients taking part in the study will be assigned by chance into two groups.             -  Group 1: patients will be treated with the glycoprotein inhibitor, Tirofiban               (25mcg/kg over 3 min bolus dose and 0.15 mcg/kg/hr for 12-24 hours), started               immediately after insertion of the sheath.             -  Group 2: patients will be treated with equivalent placebo      All patients will be loaded with 600 mg clopidogrel at least 4 hours prior to scheduled     intervention.      All patients will have platelet function analyses at baseline and following treatment.   "
195603|NCT00407784|"     This study aims to evaluate the diagnostic value of the Aldosterone-Renin Ratio (ARR)as a     screening test for primary aldosteronism among hypertensives. The test characteristics will     be studied. Furthermore, the effect of eplerenone, a selective aldosterone-receptor     antagonist will be studied.   "
195604|NCT00394550|"     This is a research study of the effect of treating laryngomalacia (floppiness of tissue on     top of the voice box that can possibly block breathing) found in association with obstructive     sleep apnea (blockage of breathing while sleeping).      The purpose of this study is to determine which is the best treatment for children with     obstructive sleep apnea and laryngomalacia: adenotonsillectomy alone or adenotonsillectomy     with laser supraglottoplasty (removal of tissue on top of the voice box to open the airway).   "
195605|NCT00394563|"     The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain     due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624     compared to placebo over a 4 month period.   "
195606|NCT00394576|"     1. Research question Can a web-based nutritional educational intervention improve          phosphorus knowledge and control of phosphorus intake?        2. Experimental design           Following enrollment and informed consent, subjects will be randomized to one of two          arms (group1: usual care; group 2: usual care plus Internet-based nutrition module). All          subjects will undergo baseline data collection, consisting of:             1. Short form of the test of functional health literacy in adults: categorizes               individuals as having adequate, marginal or inadequate health literacy.             2. Chronic Kidney Disease (CKD) Knowledge Assessment Tool: addresses nutritional               knowledge of CKD.             3. SF-12 Health Survey version 2: a 12-item measure of health related quality of life.             4. Kidney Disease Self-Management Survey: a 58-item Likert scale based on theories               important for self-management in chronic disease.             5. 3-Day Dietary Diaries             6. Lab work:           i. Serum phosphorus, calcium and parathyroid hormone levels. ii. Circulating endothelial          cells, a novel marker for vascular damage.           Following baseline data collection, group 1 will continue with their scheduled clinic          visit, while group 2 will spend approximately 30 minutes completing a web-based          nutrition module. After completion of the module, patients will proceed with their          scheduled clinic visit.           All subjects will then be asked to return in 30-60 days to repeat some of the survey          information and blood work        3. Major risks to subjects There is the potential for some mild discomfort from the          necessary blood draws, which occur twice per subjects.        4. Potential benefits to subjects Subjects randomized to the web-based module may receive          an educational benefit from it.        5. Consent procedures Only individuals who can provide their own consent can participate.          Upon agreeing to enroll, a study coordinator or investigator will provide the subject          with a copy of the consent form, and will remain available to answer any questions.   "
195607|NCT00394589|"     This Phase IIIb, randomized, multi-national, multi-center, blinded study of Infliximab (IFX)     in subjects aged 18 and older with active RA is being conducted to assess whether increasing     either the infusion dose or infusion frequency in patients presenting with a disease flare     after an initial response to infliximab results in a significant improvement in disease     activity.      Subjects responding to an initial infliximab treatment regimen, who flare during continuation     of treatment at 3 mg/kg administered every 8 weeks, will be randomly assigned to one of 3     different dosing regimens of infliximab and will be treated for 4 or 5 consecutive infusions     for a total duration of 24 weeks. The infliximab control group and the infliximab increased     dose group are evaluator and subject-blinded. The increased frequency group is not blinded.     Clinical assessments of disease activity will be based the European League Against Rheumatism     (EULAR) criteria for response. Safety parameters will be assessed at every infusion.      A disease flare is defined by an increase in DAS28 with 0.6 or more at screening, when     compared to the DAS28 score measured immediately prior to the last Remicade® infusion and     depends upon the actual score as well. Since prior to enrollment, the subject received     Remicade® as per routine clinical practice, the days on which infusions were administered and     assessments are done during the induction period do not have to be exactly at Week 2, 6 and     14.        -  Drug: Infliximab Control (double-blinded)        -  Drug: Infliximab Increased Dose (double-blinded)        -  Drug: Infliximab Increased Frequency (open-label)   "
195608|NCT00394602|"     The primary objectives of this study are:        1. To assess the preferences of cancer patients scheduled to receive chemoradiation and          caregiver controls for side-effects of chemoradiation.             1. To compare preferences of cancer patients to those of healthy individuals.             2. To compare how patients' preferences for side-effects of chemoradiation change over               time.        2. To longitudinally assess the quality of life of cancer patients scheduled to receive          chemoradiation.        3. To determine the impact of nausea and vomiting associated with chemoradiation on          patients' quality of life and evaluate potential change throughout the duration of          chemoradiation treatment.   "
195609|NCT00394615|"     In this research study of metabolic imaging in locally advanced rectal cancer, we hope to     learn whether new medical imaging technology can help predict the response of rectal cancer     to preoperative chemotherapy and radiation therapy. Ultimately we hope this information will     in the future help us predict which patients will benefit from more or less aggressive     initial therapy for their rectal cancer.   "
195610|NCT00394628|"     Phase 1b of the study, will evaluate the safety and tolerability of AQ4N treatment at three     different dose levels.      Phase 2a of the study, will further evaluate the safety, tolerability, and in addition     efficacy of AQ4N treatment at a tolerated dose selected from Phase 1b.   "
195629|NCT00394888|"     We are conducting a study on the possible presence of PHACES in children with large facial     hemangiomas and lumbosacral hemangiomas of infancy (hemangioma in the lower back) . With this     study we hope to better understand the risk of this syndrome and to develop guidelines for     its evaluation and management.   "
195630|NCT00394901|"     The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment     of postherpetic neuralgia in a dose-ranging manner.   "
195611|NCT00394641|"     The study aims to evaluate the impact of a possible new treatment for hypertonia,     contributing to the motor disability in children with cerebral palsy (CP).      This study follows a 2005-2006 pilot study, that demonstrate a significant motor improvement     in 4 children exposed to low tones via stereophonic Headphones.(A possible mechanism is a     deep brain stimulation outspreading from the auditory pathways in certain tones) The goal of     this study is to perform a double blind randomized placebo-controlled trial (RCT) on 30     children.      A three-arm study, with one group receiving the proposed treatment-music with low tones and     the other two groups receiving a placebo (music without tones or stories) will be performed.      clinical and a non invasive laboratory measurements (surface EMG) related to spasticity,     active and passive range of movement, isometric strength and upper and lower body function     would be measured both before and after the treatment .the assessments will include also a     Visual assessment , evaluation of gaze coordination and a quality of life and a caretaker     burden questionnaires.   "
195612|NCT00394654|"     This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR     in adult patients with atopic asthma.   "
195613|NCT00394667|"     Purpose:      To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine     versus placebo in obese patients   "
195614|NCT00394680|"     Options for coronary revascularization include stent implantation and coronary bypass     surgery. Both modalities have their unique advantages and disadvantages in terms of clinical     outcomes as well as financial impact on the medical system. We wish to investigate the late     results of patients undergoing coronary revascularization, the need for re-hospitalization,     re-intervention, patient satisfaction as well as the financial burden on the medical system.     The study will be conducted by historical prospective review of hospital records in     conjunction with records of the medical insurance companies (HMO's).   "
195615|NCT00394693|"     The primary objective of this study is to evaluate the efficacy of a four-month dosing period     of intra-lesional injection of TG1042 in patients with relapsing CBCL.      Patients will receive intra-tumoral injections of an adenoviral vector construct containing     the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with     anti-tumor activity. This local administration induces tumour cell killing at the injected     tumour sites.   "
195616|NCT00394706|"     The purpose of this study is to look at two different treatments during a cardiac arrest that     occurs outside of the hospital and whether either or both treatments will increase the number     of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping     blood to the body.   "
195617|NCT00394732|"     Surgical methods offered to patients with chronic low back pain are controversial. In     addition, new and expensive treatment methods like total disc replacemet (TDR) are a     challenge for the health care services. At present, ongoing randomized studies in both Europe     and USA are comparing TDR to fusion. However, to our knowledge, no randomized trials have     compared TDR to non-surgical treatment. The aim of the present study is to evaluate the     effect of a comprehensive and structured non-surgical treatment with TDR surgery in patients     with chronic low back pain and localized degenerative disc changes.      Main hypothesis: There is no difference in treatment effect between surgery with lumbar total     disc prosthesis and a multidisciplinary rehabilitation program measured by Oswestry     Disability Index after 1 and 2 years.      Secondary hypothesis: There is no difference in cost - effectiveness between surgery with     lumbar disc prosthesis and a multidisciplinary rehabilitation program after 1 and 2 years.   "
195618|NCT00394745|"     The purpose of this study is to evaluate potential effects of valsartan on lipid subfractions     and other parameters in lipid metabolism in patients with essential hypertension and     metabolic syndrome.   "
195619|NCT00394758|"     1. To compare the recurrence rate between the use of laser vaporization and ultrasonic          surgical aspiration in the treatment of vulvar and vaginal dysplasias        2. To compare healing related complications, post-operative pain, and scarring between the          two procedures.   "
195620|NCT00394771|"     This is a 4-arm study to evaluate and compare bleeding patterns between three different doses     of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will     receive physical and gynecological exams, including Pap smear. During the study, all     participants will be required to complete a diary   "
195621|NCT00394784|"     This research is important because it allows for the determination of resistance rates to     antibiotics that may not be frequently tested by the clinical microbiology laboratory at     University of Pittsburgh Medical Center (UPMC)-Presbyterian. It also will provide antibiotic     minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying     the best empiric antibiotic option for gram-negative blood stream infections based on known     pharmacodynamic parameters.   "
195622|NCT00394797|"     The purpose of this study is to try and determine whether repair of moderate ischemic mitral     regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on     survival.We will compare patients undergoing CABG + mitral repair or CABG only groups.     Primary endpoints include late survival. Secondary endpoints include event free survival,     symptoms, and echocardiographic outcomes.   "
195623|NCT00394810|"     This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and     pharmacokinetics, of Panzem® NCD in patients with metastatic, docetaxel refractory,     androgen-independent prostate cancer.   "
195624|NCT00394823|"     The purpose of this study is to assess the impact of supportive measures on the drug     adherence of patients with essential hypertension   "
195625|NCT00394836|"     A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human     Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to     Rituximab as Monotherapy or in Combination With Chemotherapy   "
195626|NCT00394849|"     The purpose of this study is to determine if closing the tonsil fossa after tonsillectomy     leads to less pain and bleeding risk than leaving it open to heal by secondary intention.   "
195627|NCT00394862|"     Investigate the efficacy of weekly versus daily of folic acid supplementation on improving     folate, vitamin B12,   "
195628|NCT00394875|"     To determine whether the management of type 2 diabetes mellitus (DM2) can be transferred from     an internist to a supervised nurse specialized in diabetes (NSD) with a comparable quality of     clinical care, health care costs, health related quality of life (HRQOL), and patient     satisfaction.   "
195636|NCT00400400|"     Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in     gastrointestinal (GI) complications in some patients. This study will investigate the safety     and tolerability of converting kidney transplant recipients with gastrointestinal symptoms     from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated     mycophenolate sodium (EC-MPS).   "
195637|NCT00400413|"     The aim of the research is to investigate phonological processing in deafness and to examine     its influence on the neuroanatomy of reading.The basic hypothesis is that insofar as the     ability to read is closely related to the ability to segment and represent speech units, the     neuroanatomy of reading in deaf would be different from the one of hearing readers.   "
195638|NCT00400426|"     Palliative radiotherapy for head and neck cancer is widely used but the effect and side     effects are largely unknown. We will study the effect of short hypofractionated palliative     radiotherapy (20 Gy in 4 fractions) on symptom intensity and -frequency as weel as side     effects   "
195639|NCT00400439|"     This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with     coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed     study NC19453. Patients eligible to participate in the extension study will continue on the     treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with     concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6     months post study NC19453, and the target sample size is approximately 100 individuals.   "
195640|NCT00400452|"     It is hypothesized that, compared to a control group, manual wheelchair users and their     caregivers in the long-term-care setting who receive the wheelchair skills training program     will improve their wheelchair skills to a statistically significant extent and will retain     these improvements for at least one month.   "
195641|NCT00400465|"     Thyroidectomy is an operation that is commonly performed. After an operation a pressure     dressing by Hypafix is usually used due to the belief that it will help to reduce     complications such as post-operative bleeding or haematoma. However, the practice is     uncomfortable to patients and makes it hard to detect early haematomas.      We carried out a prospective randomised study to study the role of pressure dressing after     thyroid surgery by evaluating the amount of fluids collected in the operative bed by     ultrasonography compared with normal dressing.   "
195642|NCT00400478|"     This is a randomized, open label, phase III study to evaluate the ability of rituximab     maintenance therapy to prolong event-free survival in aggressive NHL.      Patients will be screened after successful standard induction therapy (CR or Cru following     standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8     cycles). Patients will be followed until an event occurs as defined in the protocol. To     evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in     patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who     have achieved a complete remission after appropriate first-line therapy, measured by     event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm)     will be recruited.   "
195643|NCT00400491|"     The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000     IU per week will result in improved metabolic control in patients with type 2 diabetes.   "
195644|NCT00400504|"     Patients with malignancies are at high risk of developing a thromboembolic complication and     their treatment with chemo- and or radiation therapy further enhances this risk.      Conventional haemostatic tests are not suitable as a screening tool of a hypercoagulable     state. A hypercoagulable profile identified with the whole blood Thrombelastograph (TEG)     Analyzer parameter maximal amplitude (MA) is reported to correlate with thrombotic events in     patients undergoing major non-cardial surgery and recurrent ischemic events in patients     undergoing percutaneous coronary intervention.      In this study we investigate the correlation between TEG measurements and thromboembolic     events in patients with newly diagnosed malignancies.      The hypotheses of this study are:        1. Patients with malignancies and hypercoagulability, defined as a TEG MA>69 mm and /or R<4          min is at increased risk of developing thromboembolic complications as compared to those          with a MA<69 mm and/or a R>4 min.        2. Hypercoagulability and hence TEG R and MA values are affected by the treatment          instituted in these patients (chemo and radiation therapy) rendering the patients more          hypercoagulable and hence at increased risk of developing thrombotic complications.   "
195645|NCT00400517|"     RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different     ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by     blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the     tumor smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide     works in treating patients undergoing surgery for high-risk prostate cancer.   "
195646|NCT00400530|"     To compare upper GI handling of fosamax and generic, because the main AE profile of     alendronate is before systemic absorption in the esophagus; differences could be relevant to     the side effect profile.   "
195733|NCT00401687|"     The purpose of this clinical research study is to demonstrate the ability of Definity®     enhanced versus unenhanced cardiac ultrasound to improve the accuracy and reproducibility of     left ventricular ejection fraction (EF) when compared to magnetic resonance imaging (MRI).   "
195647|NCT00400543|"     Obstructive sleep apnea (OSA) is associated with adverse cardiovascular outcomes, including     acute myocardial infarction and stroke. Atherosclerosis is an important step for these     events. Recent studies demonstrated the independent association between OSA and validated     markers of atherosclerosis. However, the impact of treatment with continuous positive airway     pressure (CPAP) on these markers is unknown.      The purpose of this study is to determine whether CPAP therapy can reverses early signs of     atherosclerosis in apparently healthy OSA patients.   "
195674|NCT00400894|"     Emerging from a differential proteomic study of sample pairs of prostate cancer and benign     tissue, annexin A3 (ANXA3) was chosen as a potential novel biomarker for the early and     non-invasive diagnosis of prostate cancer. We wanted to show or investigate, that:        -  ANXA3 can be detected in urine after standard digital rectal examination.        -  ANXA3 has better specificities than tPSA, in particular in the grey zone of PSA        -  ANXA3 can help avoid unnecessary biopsies        -  ANXA3 can in the long run replace PSA as a marker   "
195648|NCT00400556|"     Hematopoietic stem and progenitor cells (HSPC) are used for transplantation in patients     undergoing high dose therapy for the treatment of a range of cancers.        -  HSPC are collected from the bloodstream after treatment with medications that cause the          HSPC to move from the bone marrow into the bloodstream, a process called mobilization        -  between 5 and 60% of patients can fail to collect enough HSPC for a transplant, using          current mobilization techniques        -  this study aims to assess the safety of combining a derivative of vitamin A, ATRA with          G-CSF (the drug most commonly used to mobilize HSPC)        -  ATRA has never been combined with G-CSF for mobilization of HSPC and therefore a study          is needed to assess the safety of this combination, and whether it successfully          mobilizes HSPC   "
195649|NCT00400569|"     This is an open label single site Phase II clinical trial to identify a potentially promising     therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1     through 28 of each 42 day cycle. Treatment will be continued until there is either disease     progression or cumulative/acute toxicity.      All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma,     liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt     Cancer Center will be screened for eligibility to be enrolled in the study.   "
195650|NCT00400582|"     The purpose of this study is to evaluate the impact of genetic variations on the response to     candesartan in patients with heart failure who are already treated with an ACE inhibitor.   "
195651|NCT00400595|"     Peritoneal dialysis (PD) is used for the treatment of end-stage renal disease in     approximately 25% of patients requiring dialysis in Canada. The most common complication is     bacterial infection or 'peritonitis'. Peritonitis causes severe acute abdominal pain and may     lead to failure of peritoneal dialysis treatment, hospitalization or death, particularly if     left untreated. Amongst the strategies used to prevent peritonitis, patients are instructed     on the regular use of a prophylactic ointment around the point where the catheter exits from     the body. At the present time most centers in Canada routinely prescribe mupirocin ointment     for use at the exit site, however newer ointments have become available. One such ointment is     Polysporin Triple. The aim of this study is to determine if catheter related infections can     be significantly reduced by the routine application of Polysporin Triple in comparison to     mupirocin ointment. A multi-centre, randomized, double blind, controlled study is proposed.     Participants will be randomized to either mupirocin or Polysporin Triple and followed for 18     months or until the first catheter related infection, death or catheter removal. The     difference in catheter related infection rates will be compared between the two groups. We     anticipate the results of this study will allow clinicians to prescribe the ointment most     likely to reduce infections. By doing so this will reduce the complication rate associated     with peritoneal dialysis and, ultimately improve survival.   "
195652|NCT00400608|"     Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA   "
195653|NCT00400621|"     The study objective was to evaluate the safety of ten consecutive days of therapeutic     acetaminophen dosing in moderate alcohol consumers. The main outcome was liver injury     (measured by an increase in mean serum ALT or AST levels). Patients were randomly assigned to     10 days of acetaminophen or placebo. Blood tests were measured at baseline, day 4 and day 11     to look for injury. We hypothesized that there would be no difference in liver enzymes     between the two groups.   "
195654|NCT00400634|"     The purpose of this double blind study is to determine whether CERE-120 (adeno-associated     virus serotype 2 [AAV2]-neurturin [NTN]) is effective and safe in the treatment of patients     with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic     injections targeting the putaminal region of the brain. The design of this study involves     approximately 34 patients receiving CERE-120 treatment via stereotactic surgery and     approximately 17 patients receiving sham stereotactic surgery (no CERE-120 administered).   "
195655|NCT00400647|"     This study will assess the quality of life in renal transplant recipients who require a     reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and     will also access the relationship between mycophenolic acid (MPA) dose in those patients     receiving enteric-coated mycophenolate sodium formulation(EC-MPS).      Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then     again at 12 weeks post-conversion.   "
195656|NCT00400660|"     GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's     future generation of Metered Dose Inhalers (MDIs). A surfactant in a MDI would provide a more     stable drug suspension, this in turn will produce a consistent dose of drug being delivered     with each puff.   "
195657|NCT00400673|"     The study was set up to assess:        1. A two-step, increasing-intensity remission induction phase. A conventional chemotherapy          course (ICE, plus G-CSF) was followed, in unresponsive patients, by sequential high-dose          cytarabine (plus G-CSF), aiming to provide an early effective rescue to as many          refractory cases as possible.        2. A risk-oriented postremission consolidation phase. The objective was to adopt allogeneic          stem cell transplantation (alloSCT) in high-risk (HR) cases, while standard-risk (SR)          ones were consolidated with a multicycle high-dose cytarabine-containing program, which          included the use of autologous stem cells plus G-CSF to limit drug-related toxicity and          intercycle treatment delays.   "
195658|NCT00400686|"     RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat     anemia in patients with multiple myeloma.      PURPOSE: This clinical trial is studying how well epoetin alfa works in treating anemia in     patients undergoing chemotherapy for multiple myeloma.   "
195659|NCT00400699|"     RATIONALE: An outreach program may help minority or low-income cancer patients overcome     problems that keep them from receiving quality care.      PURPOSE: This clinical trial is studying how well a radiation therapy outreach program works     in minority or low-income patients with newly diagnosed cancer.   "
195675|NCT00400907|"     RATIONALE: Treatment for diffuse large B-cell non-Hodgkin's lymphoma may cause side effects     and secondary cancers later in life. An observational study that evaluates patients after     undergoing six courses of combination chemotherapy with or without rituximab and radiation     therapy may help doctors predict a patient's response to this treatment and help plan the     best treatment.      PURPOSE: This observational study is evaluating patients with diffuse large B-cell     non-Hodgkin's lymphoma to see how well treatment on clinical trial CAN-NCIC-LY9 works.   "
195660|NCT00400712|"     Once discharged from hospital many stroke survivors deteriorate medically, physically and in     their mobility function and many report their level of function and quality of life to be     poor 12 months after inpatient rehabilitation. There is an identified need for follow-up     examinations of community dwelling stroke survivors to monitor changes in function and it has     been suggested that maintenance therapy could curtail declines in function. The purpose of     this trial is to determine whether brief periods of intense client-centered rehabilitation     therapy (tune-ups) provided at 6 month intervals can alter the natural progression of     impairment (physical capacity), function and community reintegration following stroke.   "
195661|NCT00400725|"     The objective of the study is to assess the maintenance effect on scalp psoriasis of Clobex®     Shampoo 0.05% when used twice weekly.   "
195662|NCT00400738|"     Treatment with only protease inhibitors might benefit HIV patients. Laboratory data have     shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen.     This study will explore this idea.   "
195663|NCT00400751|"     Although spousal support predicts the success of a smoker's cessation efforts, social     support interventions based on teaching partners better support skills have had consistently     disappointing results. We examined the potential utility of a family-consultation (FAMCON)     intervention based on family-systems theory in a treatment-development project involving 20     couples in which one partner (the primary smoker) continued to smoke despite having or being     at significant risk for heart or lung disease. Results were promising. The 50% rate of stable     abstinence achieved by primary smokers over at least 6 months exceeds benchmark success rates     reported in the literature for other, comparably intensive interventions, suggesting that a     couple-focused intervention different in concept and format from social-support interventions     tested in the past may hold promise for health-compromised smokers. The FAMCON approach     appeared particularly well-suited to female smokers and smokers whose partner also smoked –     two sub-groups at high risk for relapse.   "
195664|NCT00400764|"     This Phase Ib/II, open-label, multicenter trial is designed to evaluate the safety,     pharmacokinetics, and efficacy of dulanermin when combined with rituximab in subjects with     follicular, CD20+, B-cell Non-Hodgkin's Lymphoma (NHL) that has progressed following a     response of ≥ 6 months duration to a prior rituximab-containing therapy. The multicenter,     international, randomized Phase II part of this study will commence only after the safety and     available pharmacokinetic data from the Phase Ib part of the study have been evaluated by the     Sponsor and have been provided to participating investigators and the FDA.   "
195665|NCT00400777|"     This study is designed to evaluate the efficacy and safety of the combination valsartan with     hydrochlorothiazide and amlodipine in hypertensive patients previously treated with valsartan     with hydrochlorothiazide and remaining uncontrolled. A naturalistic approach will be taken     comparing two different possible ways to achieve the higher dosage of the triple combination,     i.e. 160 mg of valsartan and 25 mg of hydrochlorothiazide with amlodipine 10 mg.   "
195666|NCT00400790|"     Background: Different anaesthetic agents have been shown to have different protective effects     upon heart, brain and renal function under ischaemic conditions (oxygen starvation).     Cardiopulmonary bypass takes over the work of the heart and the lungs during heart surgery,     but oxygenation of vital organs such as the brain and heart may not be perfect, and can     produce brain or heart damage as a consequence. Propofol and desflurane are commonly used     anaesthetic agents, and there has been recent research to suggest that anaesthetic agents may     provide some protection during periods where inadequate oxygenation occurs, with the     potential to reduce the degree of organ damage. Both types of anaesthetics are used for     cardiac surgery with anaesthetists choosing between them largely on the basis of personal     preference.      Aim: To determine whether the use of either propofol or desflurane as the primary anaesthetic     agent, can lead to differences in postoperative brain function, total morbidity or cost,     following coronary artery surgery with cardiopulmonary bypass.      Methods: Patients will be recruited by professional research staff and will be randomised     into one of two groups (90 in each group). They will receive a standardized technique for     anaesthesia, cardiopulmonary bypass and postoperative ICU treatment. The only difference     between the 2 groups will be as to which anaesthetic agent they receive during the surgical     period, desflurane or propofol. Measurements will involve i) brain function testing before     and 3 months after surgery ( a set of 10 verbal or manual tests), ii) incidence of delirium     in the immediate postoperative period (a survey form), iii) incidence of total postoperative     morbidity and iv) cost of hospital stay. Data collection will be by anaesthesia and research     staff and a neuropsychologist will employed for performing the brain function testing.      Anticipated timeline: Initial recruitment completed by 15-18 months following trial     commencement. Follow up completed 3 month after the last enrolment. Data validation,     statistical analysis and manuscript preparation completed by 24 months.   "
195667|NCT00400803|"     The purpose of this study is to determine whether treatment with carboplatin and gemcitabine     combined with bevacizumab every two weeks will provide increased survival.   "
195668|NCT00400816|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients     with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.   "
195669|NCT00400829|"     This phase II trial is studying how well E7389 works in treating patients with recurrent or     progressive stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy,     such as E7389, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing.   "
195670|NCT00400842|"     This study is to verify the efficacy of 3.0 g/day of SA-001 in patients with pancreatic     exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by     pancreatectomy as compared with placebo under a double-blind design using the change in a     coefficient of fat absorption as a primary endpoint.   "
195671|NCT00400855|"     Inhaling AMP causes an inflammatory response in the lung. This study will investigate whether     5-days of treatment with fluticasone propionate protects the lung from responding to the AMP     in this way.   "
195672|NCT00400868|"     The purpose of the study is to compare the short- and long-term effectiveness of an     individualized, resource-oriented joint protection intervention with the standard,     problem-oriented joint protection intervention for patients with rheumatoid arthritis.   "
195673|NCT00400881|"     To compare a new mode of mechanical ventilation, Automatic Tube Compensation (ATC) with a     traditional one, Continuous Positive Airway Pressure(CPAP), on its effectiveness for     detecting patients no longer needing mechanical ventilation.   "
195687|NCT00401089|"     The objective of the study is to determine whether Panax Ginseng with multiple interactions     with key components of brain signaling pathway, can augment the effects of antipsychotics in     Schizophrenia. We are primarily interested to examine the actions of Ginseng combined with     antipsychotics in improving the ways patients diagnosed with schizophrenia behave in social     environment, store, process and retrieve information.   "
195677|NCT00400946|"     RATIONALE: L-asparaginase is an important component of treatment for childhood acute     lymphoblastic leukemia, but is also associated with notable side-effects, including     hypersensitivity, pancreatitis, and thrombosis. We have previously reported that patients     with acute lymphoblastic leukemia in whom asparaginase treatment was discontinued because of     intolerable side-effects had survival outcomes that were inferior to those who received all     or nearly all of their intended doses. Two bacterial sources of asparaginase exist:     Escherichia coli (E coli) and Erwinia chrysanthemia (Erwinia). Generally, the E coli-derived     enzyme has been used as front-line therapy and the Erwinia-derived preparation has been     reserved for patients who develop hypersensitivity reactions. Pegylated E coli asparaginase     (PEG-asparaginase) has a longer half-life and is potentially less immunogenic than native E     coli L-asparaginase, and has been used as the initial asparaginase preparation in some     pediatric acute lymphoblastic leukemia treatment regimens.      PURPOSE: Although the pharmacokinetics of each of these asparaginase preparations:     intravenous PEG-asparaginase (IV-PEG) and intramuscular native E coli L-asparaginase (IM-EC)     have been well characterized, their relative efficacy and toxicity have not been studied     extensively.   "
195678|NCT00400959|"     TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial     infarction.      TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.      SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction     (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty     (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB)     grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al.,     Circulation, 2002).      OBJECTIVES Primary:        1. To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone          marrow (ABM) and mobilized peripheral blood (MPB) in the target population.        2. To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in          the culprit vessel of the target population, on regional and global contractile function          and on perfusion and metabolism of the infarcted area, depending on cell dose and          comparing to controls.           Secondary:        3. To evaluate the disease-related morbility of the target population.   "
195679|NCT00400972|"     The purpose of this study is to determine whether nasal intubation assisted by GlideScope     videolaryngoscopy is faster, easier, and less traumatic than nasal intubation with     conventional direct laryngoscopy.   "
195680|NCT00400985|"     The SENSE-HF study is a prospective, observational, international multi-center study     prospectively evaluating the sensitivity and positive predictive value of the OptiVol Fluid     Trends data in predicting HF-related hospitalizations and health care utilizations associated     with signs and/or symptoms of pulmonary congestion, and to define OptiVol clinical guidelines     for subject therapy management.   "
195681|NCT00400998|"     The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in     and out of season, and Park Study in season and the clinical efficacy of repeat doses of     fluticasone propionate in subjects with seasonal allergic rhinitis.   "
195682|NCT00401011|"     This is a phase I/II study of perifosine in combination with bortezomib—with or without     dexamethasone—for patients with relapsed or refractory multiple myeloma previously treated     with bortezomib. The current protocol will enroll patients with relapsed or refractory     multiple myeloma who have been previously treated with bortezomib. The patients will be     treated with perifosine, 50 mg or 100 mg qhs, in combination with bortezomib to determine if     there is any preliminary evidence that the addition of perifosine improves the outcome for     these patients. Previous treatment with perifosine will be allowed in this study. Patients     progressing on treatment with perifosine and bortezomib will receive dexamethasone 20 mg on     days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 18, and 19 of each 21-day cycle in addition to     bortezomib and perifosine.   "
195683|NCT00401024|"     RATIONALE: Collecting samples of tumor tissue and blood from patients with cancer to study in     the laboratory may help doctors learn how patients respond to treatment.      PURPOSE: This clinical trial is looking at tumor tissue samples from patients receiving     imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the     tumor tissue.   "
195684|NCT00401050|"     The purpose of this study is to compare outcomes of combined chiropractic care in anterior     knee pain patients with patellofemoral pain syndrome.   "
195685|NCT00401063|"     The purpose of this study is to assess the effects of acupuncture on aspects of health     including pain, energy level, sleep quality, activities of daily living and appetite.   "
195686|NCT00401076|"     This study is to evaluate the safety of 3.0 g/day of SA-001 (to be flexibly increased or     decreased with the range from 1.5 g/day to 6.0 g/day), which will orally be administered for     52 weeks to patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in     the non-compensatory stage or by pancreatectomy.   "
195729|NCT00401635|"     The purpose of this study is to evaluate activity and toxicity of the combination of     carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or     recurrent endometrial carcinoma.   "
195730|NCT00401648|"     to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive     epileptic subjects   "
195688|NCT00401102|"     The purpose of this study is to examine the feasibility of using Interpersonal Psychotherapy     for Depressed Adolescents (IPT-A) to treat adolescents who are experiencing symptoms of     depression and are engaging in non-suicidal self-injurious behaviors. The trial will include     recruiting 10 particpants, administering 12-sessions of individual IPT-A, and determining how     the IPT-A protocol needs to be amended to adequately address the self-injury in addition to     depression.   "
195689|NCT00401115|"     The purpose of this study is to determine the safety and tolerability of MS-R001 at     escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy   "
195690|NCT00401128|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine     together with irinotecan works in treating patients with metastatic kidney cancer.   "
195691|NCT00401141|"     Previous experimental data strongly suggest that B lymphocytes have intrinsic abnormalities     during lupus in mice spontaneously affected by the disease. This study tries to define these     abnormalities by looking at the gene expression profile of purified B lymphocytes from     patients with non active systemic lupus , compared with the gene expression profile of     purified B lymphocytes from healthy donnors.   "
195692|NCT00401154|"     The study is about the effect of an exercise program using stationary bicycling for children     with the spastic diplegic form of cerebral palsy. Spastic diplegia is a type of cerebral     palsy that involves spasticity or tightness of the leg muscles. We hope to learn whether     this type of exercise will allow the children to develop improved strength in the muscles     that bend and straighten their knees, enhance their level of physical fitness, improve their     ability to walk and improve their ability to perform other activities that are important to     them. We hypothesize that children who participate in the stationary cycling intervention     will gain strength in the muscles that bend and straighten their knees, will be able to     complete a 600 yard walk run test (a test of endurance) more rapidly, and will improve their     score on a test of function called the Gross Motor Function Measure (a test designed     specifically for children with cerebral palsy).   "
195693|NCT00401167|"     Alzheimer's disease (AD) is the most common form of dementia and is characterized by both     cognitive and behavioural symptoms (Behavioural and Psychological Symptoms of Dementia;     BPSD). To date, there are only modestly effective treatments for BPSD, and these treatments     are associated with an increased risk of mortality in elderly dementia patients. We plan to     study whether treatment with medication memantine improves BPSD in severe AD patients.     Thirty-two AD patients with significant BPSD, including agitation and aggression, will be     treated for three months with memantine. Assessments of behavioural symptoms and global     clinical outcomes will be completed after one, two and three months of treatment.   "
195694|NCT00401180|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and temozolomide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel and     temozolomide in treating patients with metastatic cancer.   "
195695|NCT00401193|"     The purpose of this study is to determine whether XP12B is effective and safe in the     treatment of women with heavy menstrual bleeding associated with menorrhagia.   "
195696|NCT00401206|"     To determine safety and effectiveness of dexmedetomidine when administered for conscious     sedation during flexible bronchoscopy (FB) in patients with Chronic Obstructive pulmonary     Disease (COPD).   "
195697|NCT00401219|"     This study will compare the bioavailabity of three new investigational combination     formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed     formulation of Premarin and MPA, Prempro™. Prempro™ is indicated for use after menopause in     women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe     dryness, itching, and burning, in and around the vagina; and to help reduce your chances of     getting osteoporosis (thin weak bones). The purpose of this study is to determine if these     new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as     Prempro in healthy postmenopausal women.   "
195698|NCT00401232|"     This is a study to collect blood from volunteers to assist in assay development.   "
195699|NCT00401245|"     Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor     (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated     with menopause. Nausea is the most common adverse event that is observed in clinical studies     and is the main reason for discontinuation during the first week of therapy. Other adverse     events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when     subjects abruptly discontinue the medication. The purpose of this study is to evaluate     several titration and tapering regimens of DVS SR to ensure a better tolerability profile at     the start and completion of treatment. In addition, this study will provide a long     posttreatment follow-up to assess any symptoms after treatment is discontinued.   "
195700|NCT00401258|"     We hypothesize that duloxetine treatment will be associated with improvement in symptoms of     IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder.      During this 12-week, open-label, outpatient study, male and female subjects between the ages     of 18 and 65 years who have been diagnosed with irritable bowel syndrome (IBS) will be     treated with open-label duloxetine.   "
195701|NCT00401271|"     The purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg,     200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days,     in patients with uncomplicated, smear-positive pulmonary TB.      The four OPC-67683 treatment groups will comprise 12 patients each and the one standard     therapy (Rifafour e-275) group six patients.      Trial 242-06-101 is an exploratory and not a confirmatory trial and as such no hypothesis     will be tested statistically.      The control group, six patients treated with Rifafour, will serve as an control to confirm     the microbiological assessments during the trial.   "
195702|NCT00401284|"     The purpose of this study is to determine whether a compound known as EVT 201 is effective in     treating elderly patients diagnosed with primary insomnia who also have moderate daytime     sleepiness.   "
195703|NCT00401297|"     The purpose of this study is to determine what types of cells participate in the defense of     humans against Leishmania (skin parasites). People 18-70 years of age who have leishmaniasis,     have healed leishmanial lesions, or are healthy are being invited to participate in this     study. Approximately 150 people will participate in the study. Participants will be asked to     provide some general information about themselves and about skin sores, if they have any. A     skin test will be performed and a blood sample will be obtained. This study involves up to 3     visits; the first visit will last up to 5 hours and the second visit will last for 30     minutes. The third visit may be scheduled within 3 days after the second visit.   "
195704|NCT00401310|"     The safety and efficacy of MK0724 will be assessed in patients with acute middle cerebral     artery stroke using the Action Reach Arm Test (ARAT). This test allows measurement of a     specific functional deficit and subsequent recovery correlating with the specific area of     stroke in the brain.   "
195706|NCT00401336|"     Iron excess is increasingly regarded as an important cofactor in the morbidity attributed to     many disorders. Assessment of body iron stores by measurement of serum ferritin     concentrations has poor specificity and the most reliable method is histological or     biochemical assessment from a liver biopsy. Because liver biopsy is an invasive procedure,     imaging methods have been developed to detect and quantify hepatic iron content. The aim of     the study is to use a simplified magnetic resonance imaging (MRI) technique to quantify     simultaneously iron and fat contents in the liver and to compare the results to the     quantification obtained biochemically.   "
195707|NCT00401349|"     CIDEIM, Centro Internacional de Entrenamiento e Investigaciones Medicas, is conducting a     research study about the disease Cutaneous Leishmaniasis, which is caused by the Leishmania     parasite and causes skin sores. Researchers hope to find out how the human body defends     against Leishmania. A total of 472 individuals, ages 7 to 70 years, belonging to one of the     following groups will be included in this study: recurring disease, chronic disease, disease     with no sign or symptoms (asymptomatic), and healthy individuals. Study procedures will     include a questionnaire and buccal swab (swabbing of the inside of the cheek with a cotton or     wooden applicator). In addition, asymptomatic and healthy individuals will provide a blood     sample. Study participation will be up to 1.5 hours.   "
195708|NCT00401362|"     To test the effectiveness of MNTX in advanced illness subjects.   "
195709|NCT00401375|"     To evaluate the safety and efficacy of MNTX in patients who have undergone segmental     colectomy and to assess if the time between the end of surgery and the first bowel movement     is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo     regimen.   "
195710|NCT00401388|"     This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part     sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg     orally qhs with food until disease progression. The goals of this study include:        -  In this study a daily dose of perifosine previously determined to be relatively          non-toxic will be evaluated in patients with chondrosarcomas, alveolar soft part          sarcomas and extra-skeletal myxoid chondrosarcomas.        -  Response to therapy will be based on regression of measurable disease according to Choi          criteria. Time to progression and duration of stable disease will be measured as          secondary endpoints of the study.   "
195711|NCT00401401|"     The purpose of this study is to investigate the safety of zalutumumab in combination with     chemotherapy and radiotherapy as treatment of patients with head and neck cancer   "
195712|NCT00401414|"     In this research study, the investigators are trying to find a better way to set the dose of     a common blood-thinning medication.      Patients with blood clots or a risk of blood clots (or stroke) sometimes have to take an     approved medication called warfarin. Warfarin is a commonly prescribed, approved blood     thinning medicine taken by mouth. There is a certain level of warfarin that is best for each     patient at a particular time. It is hard for a doctor to choose and maintain the right dose     of warfarin for each patient. Too much or too little warfarin in the blood can cause serious     health problems.      A nomogram is a tool that helps doctors decide on the right dose of warfarin. The usual way     for finding the right dose of warfarin is for doctors to take an educated guess and use a     trial and error approach. Patients have frequent blood tests to help doctors keep track of     how well the dose level is working.      Up until now, if a patient had good blood test results over half of the time, that was as     well as doctors could do. The purpose of this study is to see whether the investigators can     create a reliable new warfarin nomogram that will allow them to dose a patient correctly more     often, perhaps about 3 times out of 4. The nomogram the investigators are studying uses     information about a patient's health and genes to decide on the best dose of warfarin.      The investigators don't yet have a reliable, safe way to choose the correct dose. In this     study, the investigators will use a genetic blood test to try to find a better way. Genes are     the parts of each living cell that allow characteristics to be passed on from parents to     children. The investigators know that people with certain genes seem to respond to warfarin     in a certain way. From a blood sample, the investigators can look at patients' genes and try     to predict the response to the blood-thinning medication.      There will be about 500 subjects taking part in this study. They will come from participating     Partners' Hospitals, including Brigham and Women's Hospital, Massachusetts General Hospital,     Faulkner Hospital, Newton-Wellesley Hospital, Spaulding Rehabilitation Hospital, and North     Shore Medical Center. The U.S. Food and Drug Administration (FDA) has approved warfarin for     use as a blood thinner.   "
195713|NCT00401427|"     The combination of vinorelbine with weekly trastuzumab has produced high response rate in     HER2 overexpressing metastatic breast cancer (MBC). The present phase 2 study was planned to     test activity of the same combination, with trastuzumab given every 3 weeks, rather than     weekly.   "
195714|NCT00401440|"     The hypothesis of the study is that the induction abortion interval time will be     significantly shorter in the group receiving vaginal misoprostol every six hours in     comparison to the group who are receiving vaginal misoprostol every twelve hours.   "
195731|NCT00401661|"     Primary objective:        -  End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation          domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign          prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.      Secondary objectives:        -  MSHQ-EjD improvement by visit        -  Improvement in International Prostate Symptom Score (IPSS) total score, voiding and          filling subscores, nocturia and bother score at end-point and by visit        -  Onset of action of XATRAL 10mg OD        -  Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.   "
195732|NCT00401674|"     The purpose of this study is to evaluate the toxicity and activity of weekly administration     of carboplatin and paclitaxel as first-line chemotherapy for elderly patients with ovarian     cancer stage IC-IV.   "
195715|NCT00401453|"     Insulin resistance is a central feature of Diabetes mellitus type 2 (Stumvoll et al. 2005).     Hypo- and hyperglycemic states are associated with adverse inpatient outcomes (ADA et al.     2006 Diab Care) and with the development of microvascular complications (UKPDS 34 Lancet     1998).      A long known therapy for the acute treatment of patients with deteriorated glucose metabolism     and insulin resistance are carbohydrate days. The principle of the therapy was firstly     introduced in 1903 by Carl von Noorden (Noorden et al. 1903). The diabetic patients were     treated for several days with a carbohydrate rich diet with fat restriction. Surprisingly,     this resulted in an amelioration of glucosuria. Today it's still a valuable tool for patients     with uncontrollable diabetes mellitus and severe insulin resistance (Willms B. 1989). But up     to now there has been no systemic evaluation of carbohydrate days in patients with     deteriorated Diabetes mellitus and insulin resistance.      The investigators conducted a pilot study with 14 patients to evaluate the efficacy of two     days of oatmeal on insulin resistance and glucose metabolism in an acute clinical setting and     after a four week outpatient period. Inclusion criteria were type 2 diabetes with     deteriorated glucose metabolism, insulin resistance defined as an insulin dosage of more than     1 U per day and kg bodyweight. Within this pilot trial the investigators found a marked     decrease of insulin requirements (~40%) and mean daily blood glucose to a mean blood glucose     of 114.7±36.7 mg/dl in the acute setting as well as after the four week outpatient period     (Lammert et al. 2006).      The most important shortcomings of this study were the hypocaloric interventions in both     groups (diabetes-adapted diet: 1500kcal/d vs. oatmeal 1200kcal/d) making it difficult to     attribute the observed effects to oatmeal alone as well as the uncontrolled nature. These     design flaws have been addressed within this new clinical trial. The investigators plan an     open label, cross-over study with isocaloric interventions (oatmeal and diabetes-adapted     diet: ~ 1200kcal/d). The intervention comprises two days of oatmeal (third and fourth day)     within a 5 day hospital stay. The control is only treated with 5 days of diabetes adapted     diet. Thereafter, the patients are followed every four weeks for an overall of 16 weeks.   "
195716|NCT00401466|"     The completed MADIT II study has shown that implantation of a cardioverter-defibrillator     (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial     infarction reduces death from any cause. The probability of the first therapy due to     ventricular tachyarrhythmia was about 34% within 3 years. With a 3-month ICD-follow-up     scheme, as it is in the standard ICD therapy, the majority of patients is followed more     closely than necessary with respect to anti-tachyarrhythmia ICD therapy.      A Home Monitoring (HM) function has been integrated into several ICD models from Biotronik     (Berlin , Germany), for close remote monitoring of ICD patients. The HM function may     substitute in-clinic follow-up controls.      The objective of our study is to compare a standard 3-month follow-up scheme and a 12-month     follow-up scheme using HM in ICD recipients with the MADIT II indications. The comparison     should be made with respect to the difference in follow-up burden and the associated costs,     and regarding possible impact of the remote follow-up via HM on all cause mortality,     hospitalization, and patients' quality of life.   "
195717|NCT00401479|"     This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, retards the     emptying of the colon and increases total colonic transit time.   "
195718|NCT00401492|"     The main purpose of this study is to describe activity and toxicity of single-agent     gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin     (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients     with advanced non small cell lung cancer   "
195719|NCT00401505|"     The purpose of this study is to determine the reasons why multiparous women (women who are     pregnant and have been pregnant before) might still be susceptible to rubella.   "
195720|NCT00401518|"     The purpose of this study is to determine if the ACADIA® Facet Replacement System is     effective in the treatment of spinal stenosis. The primary objective of the study is to     evaluate the overall success rate of the Anatomic Facet Replacement System in patients with     spinal stenosis when compared to a posterior spinal fusion control.   "
195721|NCT00401531|"     The purpose of the study is to provide immunogenicity and safety data of the investigational     hexavalent vaccine when it is given concomitantly (the same day at separate injection sites)     with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB     vaccine at birth.      Primary Objective:      To demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine induces an immune     response that is at least as good as the response following Infanrix™-Hexa in terms of     seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6     months), when co-administered with Prevnar®      Secondary Objectives:      Immunogenicity:      To describe in each group the immunogenicity parameters to each vaccine component (for     DTaP-IPV-HB-PRP~T and Infanrix™-Hexa) one month after the third dose of the primary series.      Safety:      To describe the overall safety after each injection.   "
195722|NCT00401544|"     To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously     (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron     supplementation in the treatment of anemia in patients with non-myeloid malignancies who were     receiving multicycle chemotherapy.   "
195723|NCT00401557|"     The purpose of this study is to determine how the body defends itself against Leishmania     (Viannia), a parasite that can cause a skin infection and skin sores. Certain cells in the     immune system act more aggressively against Leishmania in people with mild Leishmania     symptoms than in those who have long-term or recurring symptoms of the disease. Participants     in the study will include people who currently have Leishmania infection, people who have had     the infection in the past, and people who have never been exposed to the parasite. This study     will enroll 220 adults, ages 18 to 70 years, at 3 sites in Colombia. Blood samples will be     collected from volunteers at least once during the study. Participants will also undergo HIV     testing. Volunteers will participate in up to 2 study visits, scheduled 2-3 weeks apart.   "
195724|NCT00401570|"     This clinical trial is being conducted to determine tumor response and preliminary safety of     a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that     is required for the establishment of new blood vessels during tumor growth, a process known     as angiogenesis.   "
195725|NCT00401583|"     This is a Phase I study to determine the effect of GW786034 (pazopanib) on P450 enzymes. This     study will help determine which types of drugs may interact with GW786034.   "
195726|NCT00401596|"     This was a multicenter, open label, randomized, controlled, safety trial in subjects aged     6-75 years with a diagnosis of moderate to severe, persistent asthma. A total of 1899     subjects were randomized (2:1) to either the active treatment group or the control group.     Upon successful completion of the screening period (~2 weeks), each subject entered the 24     week study.   "
195727|NCT00401609|"     The purpose of this study is to describe the activity and toxicity of gemcitabine combined     with four different drugs (carboplatin or cisplatin or etoposide or vinorelbine) as first     line treatment of elderly patients with extensive small cell lung cancer.   "
195728|NCT00401622|"     To assess the clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52     weeks of use.   "
195736|NCT00401726|"     The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in     subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a     patient management program, which aims to help patients achieve successful outcomes by     reinforcing physician treatment efforts, providing feedback to treating physicians, and     encouraging better physician-patient communications.   "
195737|NCT00401739|"     Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by     uncontrolled proliferation of the myeloid line of white blood cells and impaired production     of normal blood cells. If untreated, patients die of infection or bleeding usually in a     matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the     cells that are thought to drive AML but that are not effectively killed by standard     treatment. The aims of the study are to determine a biologically active dose of CSL360 and     generate understanding of a rational schedule of administration for future studies.   "
195738|NCT00401752|"     The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily     and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of     gastric ulcers in patients receiving daily non-steroidal anti-inflammatory drug     (NSAID)therapy.   "
195740|NCT00401778|"     This is a Phase 1b pre-operative lung cancer trial wherein patients with operable lung cancer     will be treated with RAD001 to evaluate the target effects of this compounds on relevant     molecular pathways and on the 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) uptake     of the tumor by a positron emission tomography (PET) scan at baseline and immediately prior     to surgery. The safety profile of RAD001 will also be evaluated.   "
195741|NCT00401791|"     The study is designed to compare muscle energy capacity in men with obesity or diabetes as     compared to athletes. This study will also enable researchers to determine whether MRS can     replace muscle biopsy for this type of assessment.   "
195742|NCT00401804|"     The primary objective of the study is to evaluate the activity of BDD in subjects with acute     renal failure as measured by· reversal of acute renal failureSecondary objectives· tumor     response (complete and partial response)· To evaluate the safety of Bortezomib-     Doxorubicin-Dexamethasone in this patient population· to evaluate the activity of Bortezomib-     Doxorubicin -Dexamethasone on progression free survival · to evaluate the activity of     Bortezomib- Doxorubicin -Dexamethasone on overall survival   "
195743|NCT00401817|"     Primary Objective      1. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP     (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL).      Secondary Objectives        1. To evaluate the response rate and time to disease progression of the RA-CHOP regimen in          patients with newly diagnosed MCL.        2. To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP          treatment.   "
195744|NCT00401830|"     This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to     placebo in reducing the signs and symptoms of fibromyalgia syndrome.   "
195745|NCT00401843|"     The purpose of Part 1 of the study is to determine the safety of the combination of     Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to     compare the length of progression free survival for those patients given CNTO 328 and     bortezomib to those patients given bortezomib alone.   "
195746|NCT00401856|"     The aim of this study is to determine if therapy with the aldosterone antagonist, Eplerenone,     is associated with improved remodeling of the left ventricle in patients with cardiomyopathy.     We will determine if any benefit to cardiac remodeling is associated with improved clinical     outcomes, including improved exercise capacity and reduced incidence of major adverse cardiac     events such as death, hospitalization for heart-failure, serious heart rhythm disturbances     and transplantation.      The null hypothesis is that therapy with Eplerenone over 12 months is associated with an     improvement in cardiopulmonary exercise capacity and furthermore that treatment is associated     with improved clinical outcomes.      In order to test this hypothesis we will study stable patients on optimal drug therapy with     documented cardiomyopathy using a trial design where therapy will be randomized,     double-blinded and placebo-controlled. This will reduce the likelihood of any 'researcher     bias'. Patients will be recruited from the Heart-failure Service at the Royal Brompton     Hospital.   "
195747|NCT00401869|"     The purpose of this study was to compare the effect of epoetin alfa to preoperative     autologous blood donation (PAD) on postoperative vigor (a measure of functional ability and     well-being) and handgrip strength in patients undergoing hip or knee surgery.   "
195748|NCT00401882|"     The purpose of this research study is to evaluate the effectiveness of metoprolol, a beta     blocker, in treating patients in the hospital with a cardiac arrest. It will be given     intravenously (given into a vein). The subjects who will take part in this study are 18 years     of age or older, are experiencing a cardiac arrest in the hospital, and are in a life     threatening situation. Patients who develop a cardiac arrest require prompt electrical     defibrillation (electrical shocks) to restore the normal beating rhythm of the heart. In     patients who do not respond to electrical defibrillation, current standard of care recommends     the use of medications which have been shown to be of unknown benefit. Some people recover     from a cardiac arrest, but many people do not. We want to learn whether giving metoprolol     will improve survival of patients with a cardiac arrest. A total of 100 patients will be     enrolled in the study. Patients will receive either the standard of care with the drug     epinephrine or the standard of care plus metoprolol.   "
195749|NCT00401895|"     Coated stents with different diameters are presently commercially available, but clinical     studies on the assessment of the best stent diameter for a better clinical efficacy, a     reduced number of complications, and an effective portal pressure reduction (essential in the     treatment of those pathologies in which TIPS is indicated) still do not exist.      Aim of the study The purpose of our study is to compare the clinical efficacy and the     incidence of complications of TIPS created with 8- and 10-mm covered stents in patients with     hepatic cirrhosis.   "
196113|NCT00413725|"     The purpose of this study is to determine the safety, efficacy, and tolerability of a     three-dose regimen of an adenovirus-based HIV-1 vaccine in healthy South African adults.   "
195750|NCT00401908|"     The rate of complication and death of patients with acute digestive tract bleeding is     increased in the setting of acute coronary heart disease. The aim of the study is to     establish the relative importance of the risk factors contributing to the death rate from     acute digestive tract bleeding in patients admitted with acute coronary heart disease.   "
195751|NCT00401921|"     The primary aim of this protocol is to investigate a possible new, neuroprotective treatment     to prevent cognitive deficits that occur after carotid endarterectomy. We will investigate     whether a widely used antibiotic agent - minocycline - that has shown neuroprotective effects     in animal models of neurological diseases - can reduce the cognitive deficits associated with     the surgical procedure of carotid endarterectomy (CEA). Because these cognitive deficits are     believed to be a result of small strokes (due to emboli and/or hypoperfusion), this study     will provide preliminary data on the use of this drug as a neuroprotective agent in stroke -     a leading cause of disability.      (1) The first aim of this study is to examine whether 5 doses of minocycline administered 36     hrs before and 1 dose 12 hrs after the surgical procedure in patients undergoing CEA are     effective to reduce the cognitive deficits associated with this procedure as compared with     placebo.      a. The null hypothesis is that there is no difference in cognitive performance changes after     CEA between the patients that receive placebo or minocycline.   "
196636|NCT00424957|"     The purpose of the current study is to look into the pathogenesis of a severe medical     condition causing acute episodes on the central nervous system as seen in majority of     patients with liver cirrhosis.   "
195752|NCT00401934|"     Cholera is a severe diarrhea illness caused by bacteria. The purpose of this study is to     better understand how the immune systems of people in Dhaka, Bangladesh, fight infection with     cholera. Understanding immune responses that influence the outcome of infection with cholera     can assist in the development of more effective cholera vaccines. The International Center     for Diarrheal Diseases Research, Bangladesh (ICDDR,B) will enroll in this study 75 patients     with acute cholera and 250 of their household contacts. Individuals ages 2-60 years are     eligible. Study participation will last 1 year for cholera patients and 30 days for household     contacts. Participants will come to the ICDDR,B for 3 (household contacts) or 4 (cholera     patients) study visits, and field workers will visit them at home at other times. For all     participants, blood samples will be taken at each of the ICDDR,B visits. Household contacts     will have rectal swabs taken at 2 ICDDR visits and during field worker visits.   "
195753|NCT00401947|"     The purpose of this study is to Investigate the Safety, Tolerability, Pharmacokinetics and     Antiviral Activity of Multiple Doses of ACH-0137171 in Subjects with Chronic Hepatitis C     Infection   "
195754|NCT00401960|"     The aim of this study is to determine the safety and efficacy of daptomycin when used as an     adjuvant agent to standard care in the treatment of proven native valve Enterococcal     endocarditis. Patients with this disease will be offered the option of receiving daptomycin     at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already     receiving. The hypothesis of this study is that daptomycin added to standard therapy for     Enterococcal endocarditis is safe and efficacious.      Patients who receive daptomycin + standard therapy will be compared to patients who receive     standard therapy alone with respect to the following outcomes:        1. Safety.             1. The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured.             2. The frequency of muscle toxicity or renal toxicity, as determined by predefined               criteria.        2. Efficacy.             1. Clinical efficacy.                  -  Time to clearance of bacteremia                  -  Cure at 6 weeks following completion of antibiotic therapy                  -  Mortality at 6 weeks following completion of antibiotic therapy             2. Microbiologic efficacy.                  -  Peak and trough serum bactericidal titers                  -  The minimum bactericidal concentration of Enterococci to daptomycin      We expect to enroll 40 patients over 2 years.   "
195755|NCT00407797|"     The purpose of this study is to assess the clinical improvement by partial seizures     reduction, safety and tolerability of subjects having partial epilepsy related to the     adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED     (Antiepileptic drugs).   "
195756|NCT00407823|"     The purpose of this study was to compare ACCM/PALS guidelines performed with and without     central venous oxygen saturation monitoring on the morbidity and mortality rate of children     with severe sepsis and septic shock.   "
195757|NCT00407836|"     The hallmark of HIV infection and AIDS is the continuous attrition of CD4 T cells. One of the     mechanisms that may account for the CD4 attrition , is autoimmunity against the CD4 T cells,     caused by autologous immune cells. Vaccination against autoimmune reactive T cells has been     successfully tried in animal models of autoimmune diseases and is now being tried in patients     with Multiple Sclerosis. The purpose of the present study is to test this hypothesis in HIV     infection. We will vaccinate HIV infected patients in whom specific autoimmune reactivity     against CD4 is present , with their own CD4 reactive T cells. Following that, we shall study     the patients and find out if the T cell vaccination caused a rise in CD4 T cell levels, and     whether it influenced HIV viral load, as well as HIV and CD4 specific immunity.   "
195758|NCT00407849|"     Phase I/II study with intravitreal triamcinolone acetonide microspheres(RETAAC)for treatment     of diffuse diabetic macular edema unresponsive to laser photocoagulation. Study hypothesis is     that single intravitreal injection of RETAAC is safe and efficient compared to conventional     treatment. Fifty patients will participate in this study and will be randomized into     treatment and observation groups. Efficacy will be evaluated by best corrected visual acuity     and macular thickness measured by optic coherence tomography (OCT) after 12 months of     treatment.   "
195759|NCT00407862|"     Inhibition of RAS delays onset of diabetes in clinical studies. Preliminary evidence suggests     that telmisartan may have unique metabolic properties compared to other ARB due to activation     of PPARγ.      This should be tested in comparison with an ARB that is metabolically neutral in already     published studies.      H0: Telmisartan is not different from Losartan with respect to metabolic and vascular     effects.      H1: Telmisartan is different from Losartan with respect to metabolic and vascular effects.   "
195760|NCT00407875|"     Purpose:      The purpose of this trial is to compare two different treatment options for patients with low     risk and low-tier intermediate risk prostate cancer. The two treatment arms being compared in     this study are: (control arm) permanent interstitial prostate brachytherapy (PIPB) VERSUS     (experimental arm) intensity modulated external beam radiation therapy (IMRT).      Hypothesis:      The acute and late toxicities experienced by patients in the experimental arm (IMRT) are not     significantly worse then the toxicities experienced by patients in the control arm (PIPB).   "
195762|NCT00407901|"     The purpose of this research is to evaluate how accurately a proposed Functionality     Assessment Questionnaire measures the differences between low-functioning and     high-functioning visually challenged individuals who are legally blind.   "
195763|NCT00407914|"     The purpose of this study is to compare the effectiveness of Aquamid and Restylane in     aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety     of Aquamid through 12 months after treatment.      The study includes an extended follow up to 24 months.   "
195764|NCT00407927|"     The purpose of this trial is to determine the safety, efficacy and tolerability of two doses     of the study drug compared to placebo for the treatment of subjects with seasonal allergic     rhinitis.   "
195765|NCT00407940|"     The rise of minimal access surgery has heralded the approval of a number of endovascular     devices with similar indications. This is particularly true for the treatment of lower     extremity ischemia. Comparable devices are selected for patient use somewhat arbitrarily,     often dependent on industry influence. An unmet need is NON-industry sponsored prospective     trials COMPARING devices head-to-head so that endovascular surgeons can even contemplate     evidence-based device selection. At present, we seek to compare two new high-technology     devices that are indicated to treat lower extremity arterial stenoses associated with     claudication.   "
195766|NCT00407966|"     This phase II trial is studying the side effects and how well giving alvocidib together with     cytarabine and mitoxantrone works in treating patients with newly diagnosed acute myeloid     leukemia. Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxantrone, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more cancer cells.   "
195767|NCT00407979|"     Cathelicidins are small proteins in the human body that protect against infection. The     purpose of this study is to determine if the amount of cathelicidins and other small proteins     found in saliva can predict the amount of these in the skin of people who have acute atopic     dermatitis (AD) or psoriasis.   "
195768|NCT00407992|"     The purpose of this study is to evaluate the safety and the efficacy of occipital nerve     stimulation treating Chronic Migraine Headache   "
195769|NCT00408005|"     This randomized phase III trial is studying different combination chemotherapy regimens and     their side effects and comparing how well they work in treating young patients with newly     diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more cancer cells. It is not yet known which combination chemotherapy regimen is     more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic     lymphoma.   "
195770|NCT00408018|"     P276-00 is a molecule derived from Rohitukine, which through pre clinical assays was     identified as a selective Cdk4-D1 and Cdk1-B inhibitor.The inhibition of these Cdks causes     cell cycle arrest between the G1-S transition thus blocking the cell cycle events at an early     stage of development. It therefore has the potential for being efficacious with lesser side     effects.   "
195771|NCT00408031|"     For many depression patients treatment changes are required, including switching to another     antidepressant and addition of a second antidepressant or a non-antidepressant agent     (augmentation). The need to modify treatment is usually necessary because of partial or no     response to first-line monotherapy or the failure to achieve remission although treatment     response (improvement) has been obtained. These caveats of presently available antidepressant     drugs highlight the need for innovative pharmacological treatment strategies. Recent data     suggest that N-methyl-D-aspartate receptor (NMDAR) antagonists and partial agonists at the     NMDAR-associated glycine binding site may represent a novel type of antidepressant     medications. These types of compounds protect vulnerable neurons against a variety of     insults, including stress-induced damage, and may serve to enhance and maintain normal     synaptic connectivity. In animal models, these compounds mimic the effects of clinically     effective antidepressants. Furthermore, down-regulation of the glycine site of the NMDAR was     found to be a common feature of currently used antidepressant medications. D-cycloserine (DCS     , Seromycin) is a broad spectrum antibiotic, in use for over thirty years against     tuberculosis, that acts as a partial agonist at the NMDAR-associated glycine site. Beneficial     antidepressant effects have been reported with 500-1000 mg/day DCS regimens in depressed     tuberculosis patients and recent preliminary findings suggest that DCS may also be beneficial     in the treatment of major depressive disorder. The antidepressant effects of DCS seem to     reflect consequences of its capacity to reduce NMDAR receptor function. In the present     project, it is proposed to assess, using a random assignment, parallel-group, double blind,     placebo controlled design, the effects of a NMDAR -antagonist DCS dose regimen, 250 --> 1000     mg/day for 6 wks, as adjuvant pharmacotherapy for treatment-resistant major depressive     disorder patients. The study methodology includes the assessment of DCS effects upon symptoms     profile, neurocognitive tests performance, amino acids serum levels, and brain     electrophysiology parameters associated with the prepulse inhibition-startle response     paradigm. It is hypothesized that significant beneficial DCS treatment effects will be     registered.   "
195772|NCT00408044|"     Chronic pain associated to sternotomy occurs in 40 to 50% of patients after cardiac surgery.      33 to 66% of these patients suffer during 3 month and 25 to 33% have postoperative pain for     at least 1 year.      This pain has often negative effects on daily activity. Despite its frequency and importance,     the etiology of this chronic pain is not completely understood.      The goal of this study is to understand the mechanism of this chronic pain, to prevent and/or     to treat better in the future.      The sensitivity of the thorax after cardiac surgery seems to follow a dynamic evolution which     can be observed within several weeks. Therefore we decided to study this evolution.      This study is different from previous ones observing the sensitivity of the thorax at a well     defined moment immediately after the surgery.   "
195773|NCT00408057|"     This is a multi-center, open label observational study conducted over 26 weeks.      Approximately 2,500 high-risk patients with an elevated LDL-C level (> 2.5 mmol/L) will be     enrolled. Patients meeting all inclusion criteria and having none of the exclusion criteria     at Visit 1 (Screening) will be included in the study. Eligible patients that agree to     participate and sign an informed consent will be treated with either statin therapy     (increased or started or switched) or combination of statin and ezetimibe 10 mg     (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target     of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient.      After enrollment there are a total of three scheduled clinic visits. All patients will have     vital signs measured as well as a brief physical examination performed at Visit 1     (Screening).      At Visit 2 (6 weeks) patients with LDL-C > 2.5mmol/L will be treated with either statin     therapy increase or combination of statin and ezetimibe 10 mg (added/started) as per Study     Schematic (Table 1) in order to achieve the recommended target of LDL<2.5 mmol/L and     providing that this treatment is in the best interest of the patient.      At Visit 3 (12 -18 weeks) patients with LDL > 2.5 mmol/L will be treated with combination of     statin and ezetimibe 10 mg as per Study Schematic (Table 1) in order to achieve the     recommended target of LDL<2.5 mmol/L and providing that this treatment is in the best     interest of the patient.      At final Visit 4 (24-26 weeks) safety and efficacy of treatment will be reviewed. Following     Visit 4 physicians will continue to treat these patients according to their clinical     judgment.   "
195774|NCT00408070|"     The primary objective is to determine whether the addition of bevacizumab to a regimen of     carboplatin plus paclitaxel significantly improves Progression Free Survival (PFS) for     patient with Stage III suboptimally cytoreduced or Stage IV ovarian, primary peritoneal or     fallopian tube carcinomas.   "
195775|NCT00408083|"     This is a double blind crossover study designed to compare two different gadolinium products     given at the same dose to patients undergoing MRA assessment of lower legs for the evaluation     of peripheral steno-occlusive disease.   "
195776|NCT00408096|"     The purpose of this study is to determine whether there is a difference between the result of     treatment of shoulder osteoarthritis with two different shoulder prostheses.   "
195829|NCT00409448|"     This study will evaluate the effectiveness of an Internet-based psychosocial treatment in     improving problem-solving, communication skills, stress management strategies, and coping     among children who have had a traumatic brain injury and their families.   "
195777|NCT00408109|"     This study will determine if an experimental avian flu (bird flu) vaccine is safe, whether it     has side effects and if it can stimulate an immune response in people. The vaccine being     tested in this study is made from DNA (genetic material) that codes for an influenza protein     called hemagglutinin 5 (H5), which is based on the protein from the bird flu virus. The study     will determine if the body creates resistance or immunity to the H5 protein. The hope is that     an immune response to this protein may protect against bird flu virus infection.      Healthy people between 18 and 60 years old who have been vaccinated with the current season's     influenza vaccine may be eligible for this study.      Participants are randomly assigned to receive injections of one of the following: 1) study     vaccine at 1 mg dose, 2) study vaccine at 4 mg dose, or 3) placebo (salt-water solution).     They receive three injections about 4 weeks apart in the upper arm muscle. Participants     record their temperature and symptoms at home for 5 days after each injection, either on a     diary card or electronically using the Internet, and report any side effects to a study     physician or nurse as soon as possible. They return to NIH for clinic visits every 2 weeks     for the first 12 weeks, then at week 26 and at week 42 to check for health changes or     problems. Blood is drawn at all visits and urine samples are collected through week 10.      If a participant develops serious side effects, the study physician may decide that he or she     should not receive any further injections. However, all participants are asked to continue     the follow-up visits even if they do not get the full set of three injections.   "
195778|NCT00408122|"     The aim of the study is to evaluate the diagnostic procedures emission tomography in     combination with a CT scan (PET/CT) and endoscopic ultrasonography (EUS) in the preoperative     evaluation of resectability of patients with primary or secondary liver cancers.   "
195779|NCT00408135|"     The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules)     1g filling sachet in children with infections (Respiratory tract infections, Dermatological     infections, Otorhinolaryngological infections, Dentistry/Oral surgery infections).      Secondary objectives are to assess the clinical efficacy, bacteriological efficacy and     acceptability of telithromycin (20% fine granules) 1g filling sachet in children with     infections.   "
195780|NCT00408148|"     The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to     placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period.      Primary objectives:        -  To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR).      Secondary objectives:        -  To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other          lipoprotein kinetics.        -  To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters        -  To assess effect of Rimonabant on body composition        -  To assess safety of Rimonabant   "
195781|NCT00408798|"     The purpose of this study is to examine prospectively the safety and efficacy of Botulinum     Toxin A (Botox) injections in the treatment of patients with alopecia areata of the scalp.   "
195782|NCT00408824|"     The metabolic syndrome is a highly prevalent disorder, which causes atherosclerotic     cardiovascular disease and is closely associated with insulin resistance. The alteration of     the secretion of adipocytokines from accumulated visceral adipose tissue in the obese induces     insulin resistance. The purpose of this study is to identify gene polymorphisms that confer     susceptibility to the metabolic syndrome and to make up a new health guidance program based     on genetic risk assessment. About 25% of male employees over 45 years old in a certain     company are diagnosed with the metabolic syndrome in medical examination. We, the researchers     at Nagoya University, will analyze gene polymorphism and various biomarkers of over 3500     company employees.   "
195817|NCT00409292|"     The purpose of this research study is to investigate if RAD001 is an effective treatment for     pancreatic cancer that has spread and not responded to treatment. Experiments have shown that     RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory     experiments imitating cancer conditions and the results have been promising.   "
195818|NCT00409305|"     The purpose of this study is to examine the effect that betahistine has on body weight in     obese subjects.   "
195819|NCT00409318|"     This study investigates whether blockade of TNF will result in reduced inflammatory indices     in patients with the metabolic syndrome   "
195783|NCT00408850|"     An abdominal distribution of fat is associated with the greatest heart disease risk, because     commonly, several risk factors of metabolic origin cluster in these individuals. When this     occurs the condition is called the 'metabolic syndrome'.      Increased activity of the sympathetic nervous system resulting in enhanced release of the     stress hormone 'noradrenaline', may be one mechanism by which adverse cardiovascular and     metabolic sequela of the metabolic syndrome might be mediated. Impaired insulin action may be     one factor contributing to increased noradrenaline release.      The aim of this Study is to determine whether treatment with a drug called pioglitazone which     is known to improve insulin action, results in reduced sympathetic nervous system activity     and stress hormone release when compared to treatment with a dummy drug (placebo).   "
195784|NCT00408863|"     Postmenopausal women with a history of breast cancer often suffer from climacteric symptoms     such as hot flushes and sweating episodes. Conventional hormone therapy is not allowed in     such patients because there are indications that hormones may cause breast cancer to recur.      Tibolone is a steroid with estrogenic, progestogenic and androgenic activity and is     registered for treatment of climacteric complaints. Tibolone has a pharmacologic and clinical     profile that is different from conventional hormones. In contrast to conventional hormones,     tibolone does not increase breast density and causes less breast pain.      The LIBERATE study is a study in which the safety and efficacy of tibolone has been     investigated in postmenopausal women that have been treated for breast cancer.   "
195785|NCT00408876|"     The primary purpose of your participation in this study is to help answer the following     research question, and not to provide you treatment for your condition--Whether duloxetine     once daily can help patients with Chronic Low Back Pain.   "
195786|NCT00408889|"     Early organ failure occurs frequently and is difficult to predict. The study aims to define a     predictive score for early transplant failure.   "
195787|NCT00408902|"     This phase II trial is studying how well tandutinib works in treating patients who have     undergone surgery for metastatic kidney cancer. Tandutinib may stop the growth of kidney     cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to     the tumor. Giving tandutinib after surgery may kill any tumor cells that remain after     surgery.   "
195789|NCT00408928|"     The purpose of this research study is to test the safety and effectiveness of VELCADE® in the     treatment of acute graft-versus-host disease (GVHD) that has not responded to steroids or has     worsened when the steroid dose was decreased. VELCADE® is a drug that inhibits certain immune     reactions that happen when lymphocytes encounter foreign substances. We are doing this     research to determine if VELCADE® may be useful in treating GVHD.   "
195790|NCT00408941|"     The aim of the present study was to investigate the sensitivity of AEP (auditory evoked     potentials) to muscular artefacts using sedation and local anesthesia.   "
195791|NCT00408954|"     This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in     men with lower urinary tract symptoms.   "
195792|NCT00408967|"     The purpose of this study is to determine if either of two doses of EMD 273066 when given     with a low dose of cyclophosphamide will result in a second time to progression that is as     long or longer than the first time to progression   "
195793|NCT00408980|"     The aim of this study is to verify whether dietary manipulations in lactating women allow     increasing the fat and caloric content of human milk.   "
195794|NCT00408993|"     To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic     Neuropathy.   "
195795|NCT00409006|"     The purpose of this study is to compare the efficacy and safety of chemotherapy followed     sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small     cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified     as 'never smoker' since it is suggested that these patients are more likely to respond     favorably to treatment with gefitinib.   "
195796|NCT00409019|"     The purpose of this study is to find out if taking a combination of telbivudine and adefovir     or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have     been taking adefovir alone for at least 5 months and have had less than optimal responses.     The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together     will also be studied.   "
195797|NCT00409032|"     The primary objective of the study is to compare dose-response effect of three dose levels of     strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of     treatment.   "
195798|NCT00409045|"     we evaluate the presence of OSA in patients that have a computed tomography (CT) of the chest     to rule out pulmonary embolism (PE) to determine if OSA constitutes an independent risk     factor for PE.   "
195799|NCT00409058|"     The purpose of this study is to learn if using the World Wide Web to train teens and their     families in problem-solving, communication skills, and stress management strategies can help     them to cope better following traumatic brain injury (TBI). To answer this question, we will     look at changes from before the intervention to after the intervention on questionnaire     measures of problem-solving skills, communication, social competence, adjustment, and family     stress and burden. We hypothesize that families receiving the TOPS intervention will have     better parent-child communication and problem-solving skills at follow-up than those     receiving the IRC intervention. Additionally, families receiving the TOPS intervention will     have lower levels of parental distress, fewer child behavior problems and better child     functioning than those receiving the IRC intervention. Lastly, treatment effects will be     moderated by SES and life stresses, such that families with greater social disadvantage will     benefit more from the TOPS intervention.   "
195800|NCT00409071|"     The purpose of the study is to determine whether a homeopathic remedy (Cocculine®) is     effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer.      Eligible patients will be randomly assigned to one of 2-arms: Cocculine® or placebo.      The number of patients required to demonstrate a 0.5-point reduction in nausea on a visual     analogue scale, assuming an alpha risk of 5% in a two-sided test and 85% power, is 396 (198     per arm). It has been estimated that the enrollment period should be 18 months.   "
195801|NCT00409084|"     Patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood     pressure in the liver vasculature) can develop esophageal varices (dilated veins). These have     an increased risk of bleeding each year. Current recommendations are to prevent bleeding of     medium or large varices (when there is no history of bleeding) by starting a blood pressure     lowering agent known as a non-selective beta-blocker. Alternatively, rubber bands can be     placed on medium to large varices to prevent bleeding (endoscopic variceal band ligation).     Using both therapies at the same time has not been studied. In this study, we hope to     determine if the use of combination therapy with endoscopic variceal band ligation and beta     blockers is more effective than using beta blockers alone to prevent the first bleeding     episode from the varices (dilated veins). The efficacy, ability to tolerate, and     cost-effectiveness of these two treatment strategies will be compared.   "
195802|NCT00409097|"     The purpose of this study is to determine whether Rosiglitazone,decreases the ADMA     concentration and thereby increases the arginine/ADMA ratio of critically ill patients.   "
195803|NCT00409110|"     This study intends to investigate the relationship between choroidal blood flow and ocular     pulse amplitude (OPA).   "
195804|NCT00409123|"     This study tests whether women with Vasospastic Syndrome (VS) react more intensive than     controls with distal vasomotions and choroidal blood flow changes to internal cooling/warming     and external cooling/warming.   "
195805|NCT00409136|"     To evaluate physician response to human alerts that inform the clinician that his/her patient     may be eligible for thromboprophylaxis. Medical records are reviewed to evaluate prescribing     decision and to evaluate rates of venous thromboembolism.   "
195822|NCT00409357|"     The primary objective is to assess the dose-response relationship of SL77.0499 10 (alfuzosin     hydrochloride) 5 mg, 10 mg, 15 mg, and placebo once daily during a 12-week oral     administration period for the efficacy in patients with lower urinary tract symptoms (LUTS)     related to BPH.      Secondary objectives are to assess the efficacy of each dose of alfuzosin as compared with     placebo and to assess the safety of each dose of alfuzosin.   "
195823|NCT00409370|"     This study compared standard hospital restraints to a newer safety net restraint system to     compare them for acceptability, tolerance, duration of restrain, length of stay in the     hospital, and satisfaction of MD, nurse, and relatives of patients.   "
195830|NCT00409461|"     Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG     SIR) each consisting of ten type 1 diabetic patients   "
195806|NCT00409149|"     Intervention description:      Complementary Approaches to Lower Mean arterial pressure (CALM) is a multi dispensary program     aimed to reduce blood pressure in hypertensive patients. The program utilizes a naturopathic     dietary approach, education on cooking and food consumption choices, walking physical     exercise, Qi Gong - a form of Chinese slow movement exercise combined with relaxation     breathing and imagery and group therapy coaching in stress management techniques and     mind-body balancing techniques.      Trial Objectives:      To compare the effect of CALM in reducing blood pressure to the standard dietary DASH     approach in hypertensive patients.      Methodology:      120 Participants will be randomly assigned in to two groups:        -  CALM program for reducing blood pressure as the treatment group.        -  Standard DASH diet and lifestyle modification counseling as the control group. Inclusion          Criteria        -  Adult men and women over 18 years.        -  Patients using anti hypertensive medications with mean systolic blood pressure          measurements of 120-180 mm Hg and/or mean diastolic measurements of 70-100 mm Hg as          determined by a 24 hour Holter test.        -  Patients not using anti hypertensive medications with mean systolic blood pressure          measurements of 130-180 mm Hg and or mean diastolic measurements of 80-100 mmHg.        -  Signed informed consent (appears in IRB forms)      Assessment of Efficacy Primary end point efficacy will be assessed by comparing the mean BP     measurements in the CALM group to the mean BP measurements in the DASH control group. Blood     pressure measurements will be performed by 24 hours Holter BP monitoring in the beginning and     at the end of the trial.      Secondary end points efficacy will be assed by comparing CALM to DASH programs with respect     to effects use of BP medications and weight loss. Lab test and pulse wave analysis will also     be assessed at the beginning and at the end of the study.   "
195807|NCT00409162|"     A new mechanical device is evaluated for tattoo removal, comparing two types of needle     washing fluids. 30 healthy subjects with tattoos will be treated. The study hypothesis is     that the device can be used to achieve satisfactory tattoo removal.   "
195808|NCT00409175|"     This study will examine whether Fx-1006A is effective in halting the progression of Familial     Amyloid Polyneuropathy (FAP).      Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of     amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the     condition called FAP.      The prevention of the formation of amyloid by stabilization of the TTR native state should     constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR     stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP     patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless     neurological deterioration FAP patients experience.      This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and     stabilize the disease at a point in time where progression of motor and autonomic dysfunction     can be maximally effected. Male and female patients with FAP with documented V30M TTR     mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.   "
195809|NCT00409188|"     The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in     addition to best supportive care is effective in prolonging the lives of subjects with     unresectable stage III non-small cell lung cancer, compared to best supportive care alone.      A local ancillary (sub) study in European centers will evaluate the immune response in     peripheral blood after tecemotide (L-BLP25) or placebo vaccination.   "
195810|NCT00409201|"     30 patients will randomly be selected and will be administered either reboxetine or a     placebo. changes in cognition and behavior will be assessed by computer tests and scales     during a six week study period.   "
195811|NCT00409214|"     The pupose of this study is to demonstrate the safety of the Litx™ therapy and confirm the     zone of tumor destruction with escalated light doses following intraoperative treatment of     primary or recurrent glioma.   "
195812|NCT00409227|"     In latest literature more evidence is available about the positive effect of alpha blocker on     stone expulsion from the ureter. Patients benefit from less pain and shortening time to stone     expulsion. Our study is design to evaluate whether alfuzosin improves the stone free out come     following SWL.   "
195813|NCT00409240|"     Our study intends to test the efficacy of pharmacist-led group interventions on a weekly     basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant     reductions in hemoglobin A1c, lipids and blood pressure.   "
195814|NCT00409253|"     The aim of this study is to confirm that URAPIDIL is as efficient and as safe as NICARDIPINE     to correct severe hypertension in pre-eclamptic patients.        -  efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmHg after 120 min          of study drug administration.        -  safety endpoints : clinical, biological and ultrasound observation for any side          effect.All infants will be observed in the neonatology unit (during 48h).   "
195815|NCT00409266|"     The functional flexion axis of the knee can be established by computer-assisted     intra-operative data, through range of motion techniques, not specific landmarks such as     epicondyles.   "
195816|NCT00409279|"     The goal of this project is to test an intervention designed to reduce the incidence and     magnitude of the negative effects, specifically stress, anxiety, and depression, frequently     experienced by adult children who are caregivers of a parent with Alzheimer's disease (AD).   "
195852|NCT00409773|"     A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high     risk for coronary heart disease to study the effects of ezetimibe/simvastatin and     atorvastatin on lipids.   "
195820|NCT00409331|"     Primary Objective:      To determine if amifostine in combination with IMRT can mitigate the decrease in production     of saliva by the submandibular and sublingual salivary glands in patients with HNSCC.      Secondary Objectives:        1. To establish a parotid gland dose volume histogram (DVH) versus measured flow          relationship in this patient population:             -  When the mean dose is < 24-26 Gy (shift recovery time to left)             -  When the mean dose is > 24-26 Gy (DVH shift)        2. To observe mucositis in the following lower dose RT areas:             -  Upper lip             -  Lower lip             -  Right cheek             -  Left cheek             -  Right ventral and lateral tongue             -  Left ventral and lateral tongue             -  Floor of the mouth             -  Soft palate             -  Hard palate.        3. To observe the incidence and patterns of occipital scalp epilation;        4. To observe the incidence of dysphagia using the List Performance Status Scale (LPSS);          and        5. To further evaluate the safety profile of amifostine in this patient population.   "
195821|NCT00409344|"     The primary objective of this study is to test the hypothesis that time on the ventilator and     ICU length of stay will be shorter in TAA patients given postoperative sedation with     dexmedetomidine compared to those given standard sedation. Secondary endpoints are:     requirement for sedatives vasoactive drugs incidence of postoperative delirium and cost     analysis.   "
195824|NCT00409383|"     This study is designed to evaluate the safety, efficacy, pharmacokinetics, and     pharmacodynamics of combination treatment with Temodar®, Genasense®, and Abraxane® in     chemotherapy-naïve subjects with advanced melanoma and normal lactate dehydrogenase (LDH).   "
195831|NCT00409487|"     The main objective of the study is to compare the decrease of mean arterial blood pressure     over 24 hours in patients having obstructive sleep apnea syndrome and weak or moderate     hypertension, treated by Valsartan 160mg per day versus continuous Positive Airway Pressure.   "
195832|NCT00409500|"     This study will evaluate safety, tolerability and pharmacokinetics of individual oral doses     of AQW051 in Japanese healthy male subjects, and will also evaluate the effect of food on the     pharmacokinetics of AQW051.   "
195833|NCT00409526|"     Inhaled Iloprost will be administered to near term infants with Persistent Pulmonary     Hypertension of the Newborn in two different doses in order to test safety and efficacy in     reducing pulmonary artery pressure.   "
195834|NCT00409539|"     SMP-986 is a compound being developed for the treatment of overactive bladder syndrome     (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg,     40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The     hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with     SMP-986 compared to placebo, as well comparing the change in: the severity of urgency     episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr     and the mean void volume/void between SMP-986 and placebo.   "
195835|NCT00409552|"     A number of studies have shown that virtual reality (VR) can be used to distract patients     from pain and anxiety during painful medical procedures for which medication provides     inadequate relief. An inexpensive, commercially available VE could have significant impact in     reducing perceived pain involved in a variety of medical procedures. The Virtual Reality     Medical Center (VRMC) developed an engaging virtual world that proved to be effective in     reducing reported pain ratings of participants experiencing several different forms of     painful stimuli. The virtual world called Icy Cool World was found to successfully distract     patients from painful stimuli and reduce patients' perceived levels of pain. Phase II looks     to expand on these findings and examine the effectiveness as a pain distraction technique for     a variety of acute and chronic pain etiologies. The main objective of the clinical     investigation will be to expand on the findings from earlier studies and obtain a more     comprehensive analysis regarding the clinical versatility of VR pain distraction.   "
195836|NCT00409565|"     The purpose of this study is to determine if the combination of two new drugs, cetuximab     (Erbitux) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and     neck cancer. Cetuximab has recently been approved by the FDA for head and neck cancer (that     is locally or regionally advanced) when used in combination with radiation therapy. Cetuximab     is also approved by the FDA for the treatment of colorectal cancer   "
196175|NCT00414544|"     This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of     CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as     nasolabial folds (i.e., smile lines).   "
195837|NCT00409578|"     The purpose of this study is to test the hypothesis that the inhibition of the     renin-angiotensin-aldosterone system (RAAS) with the angiotensin receptor blocker valsartan     or the renin antagonist aliskiren will improve ventricular hemodynamics, as reflected by a     greater reduction in levels of N-terminal proB-type natriuretic peptide (NT-proBNP) compared     to placebo in subjects stabilized following acute coronary syndrome (ACS) who are determined     to be at high risk due to an elevated concentration of natriuretic peptides.   "
195838|NCT00409591|"     The purpose of this study is to compare the efficacy of two doses of nevirapine (NVP) given     only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose     (SD) NVP given to the mothers plus two doses to the infants, in addition to zidovudine (ZDV)     prophylaxis (from 28 weeks' gestation and for one week of ZDV in neonates) for the prevention     of mother-to-child transmission of HIV-1.   "
195839|NCT00409604|"     To determine whether the application of ventricular pacing can protect the human heart from     damage resulting from a myocardial infarction   "
195840|NCT00409617|"     The purpose of this study is to evaluate the safety of adalimumab for treatment of patients     with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on     patient general well-being, health-related quality of life (QoL), fistula healing, CD-related     extra-intestinal manifestations, work performance, and overall activity.   "
195841|NCT00409630|"     Subjects between the ages of 20-45 with mild to moderate asthma will be recruited. Following     consent, subjects will undergo an evaluation to assure no underlying metabolic bone disease.     Individuals will be treated with inhaled fluticasone low or high dose, daily for 3 months.     Serum and urine biochemical markers of bone metabolism will be collected at baseline and     monthly for three months. Adherence to study medication and adverse events will be collected     at monthly intervals. Differences between fluticasone low and high dose treated individuals     will be analyzed between groups and compared with baseline values.   "
195842|NCT00409643|"     This trial will compare valsartan and amlodipine combination therapies to valsartan and     amlodipine monotherapy,and placebo for treating patients with hypertension   "
195843|NCT00409656|"     Most high risk keratoplasties are currently performed under systemic immunosuppression.     Immunosuppressants are currently either Cyclosporine A or mycophenolate mofetile,     administered for around 6 months. Due to potentially severe adverse effects, new     immunosuppressive exerting less side effects would be desirable. Basiliximab is a monoclonal,     chimeric antibody, targeted specifically against the Interleukin-2-Rezeptor from activated     T-cells. This agent is known to specifically inhibit T-cell proliferation upon intravenous     application only twice following transplantation. Basiliximab has already been demonstrated     effective in kidney transplantation.      This investigation is a prospective, randomized clinical trial on orthotopic, high-risk     penetrating keratoplasty. Basiliximab is evaluated against systemic Cyclosporine A. Primary     endpoint is graft rejection. Secondary endpoint is clear graft survival.   "
195844|NCT00409669|"     To determine if the Barraquer tonometer provides an accurate and reliable measurement of     intraocular pressure. The Barraquer tonometer is a device used to safely and painlessly     measure intraocular pressure.   "
195845|NCT00409682|"     The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of     Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease   "
195937|NCT00410891|"     Evaluation of efficacy of topical preoperative antibiotics in patients undergoing     intravitreous injections.   "
195846|NCT00409695|"     Primary Objective:        -  To determine the response and toxicity rate at day 56 of two different dose levels of          thymoglobulin (ATG) [anti-thymocyte globulin (rabbit)] as a treatment of          steroid-refractory acute graft versus host disease (aGVHD).      Secondary Objectives:        -  To evaluate the response rate at day 28.        -  To evaluate the overall survival and non-relapse mortality at 6 months.        -  To determine the toxicity profile of thymoglobulin when used for the treatment of          steroid-refractory aGVHD in each of two dose schedules.        -  To characterize the pharmacokinetic profile of thymoglobulin in each of two dose          schedules.        -  To analyze biomarkers of cellular drug effect by quantifying T-cell apoptosis in aims of          finding the minimal effective dose.        -  To determine immune-reconstitution after administration of thymoglobulin to patients          with steroid-refractory aGVHD for each dose schedule.   "
195847|NCT00409708|"     This study will assess the frequency of chromosomal abnormalities measured in circulating     lymphocytes in treatment-naive children with Attention Deficit Hyperactivity Disorder (ADHD)     treated for 3 months with either extended release methylphenidate or behavioral therapy.   "
195848|NCT00409721|"     The purpose of the study is to investigate the effects of memantine in ALS patients using     functional outcome measures.   "
195849|NCT00409734|"     The purpose of this study is to determine if there is an increase in the frequency of formula     change in patients with pyloric sctenosis prior to being correctly diagnosed.   "
195850|NCT00409747|"     There is a subgroup of children with autism that appears to develop typically for a period of     time, and then loses social or language skills, or regresses. A recent study by Vargas and     co-workers at Johns Hopkins has demonstrated that this regressive type of autism is     associated with chronic brain inflammation as shown by an abnormal production of inflammatory     cytokines among other abnormalities.      This present study will test the effectiveness of minocycline, an antibiotic with     anti-inflammatory properties, in treating regressive autism. Although behavioral therapies     have improved some symptoms of autism, there are no medical treatments for the disorder, and     many children have ongoing behavioral difficulties. A medicine with anti-inflammatory     properties may be beneficial for children with regressive autism.      This will be an open-label trial, meaning all children in this study will receive     minocycline. They will also receive vitamin B6 to reduce the possible chance of side effects     of the minocycline.      Children ages 3 to 12 with regressive autism may be eligible for this study. The children     will take minocycline and vitamin B6 daily for 6 months. Prior to starting the medication and     vitamin B6, children will receive a comprehensive diagnostic assessment for autism as well as     a physical examination, medical history, and laboratory tests. Children will then receive     ongoing assessments to monitor their behavior, communication, language skills, and medical     issues at 2 weeks, and at 1, 2, 4, 6, and 12 months. Children who respond to the treatment     will receive an additional 3 months of minocycline and vitamin B6.   "
195851|NCT00409760|"     This trial will compare valsartan and amlodipine combination therapies to both valsartan and     amlodipine, and placebo for the treatment of hypertension.   "
195853|NCT00409786|"     Diabetes affects 18 million Americans and costs over $132 billion in both direct treatment     and lost productivity per year. It is known that weight loss, improved diet and increased     exercise can result in improvement in glucose, lipid, and blood pressure control in patients     with diabetes and reduce the incidence of diabetes in individuals at high risk. Effective     delivery of proven, comprehensive lifestyle programs is difficult because of associated high     costs.      The internet provides a venue to deliver these lifestyle programs to large numbers of     individuals while decreasing the cost per person. HealthTrak, the University of Pittsburgh     Medical Center (UPMC) patient portal, provides an ideal setting to test such a program.     HealthTrak provides participants with access to individual medical information while     facilitating electronic communication with their physicians. Portal enhancements will allow     the delivery of a comprehensive lifestyle intervention aimed at weight loss, improved diet,     and increased exercise, and provide the opportunity to communicate with experts regarding     concerns.      Through this project, we will evaluate the modification of a successful comprehensive     lifestyle intervention for delivery through HealthTrak. We will enroll and follow 50     individuals with diabetes or at high risk for diabetes for 12 months and examine change in     parameters including diet, weight, physical activity, hemoglobin A1C, glucose, blood     pressure, and lipid profile.   "
195854|NCT00409799|"     For certain tibial plateau fractures the bone is compressed due to the force acting on the     tibia during the accident. The void provoked by the compression of the bone is filled with an     appropriate filling material and the fracture is fixated. I 0401 is a new bone graft     substitute that has shown capacities to promote bone-healing. This study will test the safety     and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring     grafting.   "
195855|NCT00409812|"     The study will be undertaken at the ENT department of the Leicester Royal Infirmary and in a     research laboratory at the University of Leicester and also in the ENT department at the West     Suffolk Hospital. One hundred subjects will be recruited. Subjects will be invited to undergo     a series of smell tests using graded concentrations of 4 odours in 120ml bottles (1). This     test has been described and validated by our previous work (2). The test will be fully     explained to the subject beforehand by the researcher who will test the patient. The subject     will be started with the smallest concentration of each odour and will ascend through the     bottles until they detect 2 in a row, at which point the weaker concentration of the odour     will be taken as their threshold. They will have a threshold levels determined for the odours     phenethyl alcohol (roses), mercaptan (gas), acetic acid (vinegar) and eucalyptol (menthol).      Then, the subject will undergo a sodium citrate nasal douche at a specific concentration or     will douche with sterile water. There will be three concentrations used (3%, 6% and 9%) and a     control solution (sterile water). Patients will be randomly allocated to one of the four     groups using a coded bottle system. Both patient and tester will be blinded to the solution     used as these will be made in the pharmacy and coded for anonymity – the code will be broken     at the end of the trial. Subjects will then be retested with the bottles and threshold levels     will be observed for the four odours at 15 minute intervals over 2 hours. The purpose of the     repeated tests is to determine the length of the effect (if present) of the citrate on the     olfactory ability of the patients.      (N.B. Sodium citrate is a licensed product for use in body cavities (e.g. stomach, bladder)     and can be found in the British National Formulary – the concentrations proposed do not     exceed those used elsewhere.)        1. Wudarski TJ, Doty RL. Comparison of detection threshold values determined using glass          sniff bottles and plastic squeeze bottles.Percept Mot Skills. 2004 Feb;98(1):192-6        2. Gaskin J, Robinson A, Philpott CM, Goodenough P, Murty G. Are patients cross-sensitive          to odours in parallel threshold tests? Chemical Senses 2006; in progress   "
195856|NCT00409825|"     We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second     and third trimesters.   "
195857|NCT00409838|"     The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight     tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate     after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and     an inadequate clinical response to methotrexate   "
195858|NCT00409851|"     A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.   "
195859|NCT00409864|"     Cancer of the gallbladder (CaGB) is one of the most common causes of malignant obstructive     jaundice. Jaundice is the second most common presentation and occurs in 30-60% of patients     with CaGB. It is obstructive in nature and frequently associated with pruritus, which is very     disturbing for the patients. The usual mechanism of obstruction is direct infiltration of the     bile duct by the tumour. Most patients with CaGB with obstructive jaundice are not amenable     to a curative surgical resection and hence effective palliation is the goal of treatment.     Although surgical bypass has been the traditional palliative approach, it is associated with     substantial morbidity and mortality. Non-operative alternatives in the form of percutaneous     and endoscopic drainage are available. A few trials have shown that endoscopic drainage is     better than percutaneous drainage in patients with lower end bile duct obstruction due to     pancreatic and peri-ampullary cancer. However, the scenario is quite different in patients     with upper end of bile duct obstruction as occurs due to CaGB. Endoscopic drainage is     associated with a higher incidence of cholangitis in patients with a block at the upper end     of the bile duct and the success rate varies from 40% to 80%, while percutaneous drainage may     be associated with complications such as biliary leak and bleeding. There has been no     randomized trial comparing endoscopic and percutaneous drainage in patients with malignant     obstruction due to CaGB. The objective of the present study is to carry out a randomized     prospective trial comparing percutaneous and endoscopic biliary drainage in patients with     CaGB with obstructive jaundice and to assess their quality of life.   "
195860|NCT00409890|"     To determine whether hyoscine butyl bromide is effective in shortening the first stage of     labor, with no increase in maternal or neonatal complications.   "
195861|NCT00409903|"     We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan     reduces the activity of the sympathetic nervous system in healthy individuals - during     baseline conditions and after activation of the sympathetic nervous system.   "
195862|NCT00409916|"     The purpose of this study is to determine whether outpatient therapeutic management guided by     impedance cardiography (ICG), in addition to standard clinical assessment, will result in a     longer time in days to the first heart failure hospitalization than therapy guided by     clinical assessment alone.   "
195863|NCT00409929|"     This study will evaluate the safety and tolerability of ascending single oral doses greater     than 500 mg of AEB071 in healthy subjects   "
195906|NCT00410488|"     The goal of this clinical research study is to compare 2 treatment schedules of Aloxi     (palonosetron) in patients with sarcoma who are receiving chemotherapy with adriamycin and     ifosfamide. The safety of the drug and schedules will be studied. The effect of palonosetron     on patients' quality of life (QOL) will also be studied.   "
195864|NCT00409942|"     Torasemide is a loop diuretic (pyridine-sulfonylurea)with a wide experience in the treatment     of oedema associated to heart failure, kidney or liver disease and either in the treatment of     arterial hypertension (alone or combined with other anti-hypertensive drugs). It has been     developed a new formulation of Torasemide (Torasemide prolonged release).      The aim of this trial is to study the effects of Torasemide prolonged released in comparison     with furosemide, in the reduction of myocardial fibrosis in patients with chronic heart     failure (Class II-IV of the New York Heart Association Classification.   "
195865|NCT00409955|"     - The goals of this study are to develop a lyophilization method for anterior lamellar     transplants in Brasil and to make a comparative analysis among patients transplanted with     lyophilized and optisol corneas   "
195866|NCT00409968|"     This trial is referred to as the umbrella trial. The BATTLE program consists of this     umbrella trial plus four phase II protocols into which the umbrella patients are enrolled.     Patients will first enroll in the BATTLE umbrella trial and undergo a tumor biomarker     analysis that will be used to assign them to one of the four phase II studies. All patients     enrolled in one of the phase II BATTLE protocols must be enrolled in this protocol.   "
195867|NCT00409981|"     The PACCOCATH ISR II study is a randomized, double-blinded German multicenter trial on the     efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent     restenosis.   "
195868|NCT00409994|"     Investigating the safety and the activity of Rapamycin, administered before and during     preoperative radiotherapy in patients with an operable colorectal carcinoma. The phase I dose     escalation study will be performed in three steps (2, 4 and 6 mg). Patients entered in phase     II will follow the same tolerable treatment regimen as patients in phase I study.   "
195869|NCT00410007|"     The aim of the study is to test the following hypotheses:        1. that the function and/or regulation of AQP2 and /or ENaC in the principal cells is          abnormal in autosomal dominant polycystic kidney disease.        2. if an abnormal function of the principal cells is present in autosomal dominant          polycystic kidney disease, this woll become more pronounced at high and low sodium          intake.   "
195870|NCT00410020|"     An alpha linolenic acid (ALA) rich diet in the Lyon Diet Heart Study reduced sudden cardiac     deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994).      Since then, there has been a growing interest in ALA, ω-3 fatty acid family precursor, as a     cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic     effect of longer chain ω-3 fatty acids, DHA and EPA, derived from fish.      We therefore concluded it important to test wether vegetable source ω-3 also had     antiarrhythmic effects, as shown in animals by Leaf and McLennan, since this might also     explain the beneficial effects seen on cardiovascular mortality in the Lyon Diet Heart Study.   "
195871|NCT00410033|"     This trial is conducted in Europe. This is a single-centre, retrospective trial aiming at     comparing the antibody levels in children and adolescents.   "
195872|NCT00410046|"     The primary purpose of this study is to evaluate the health care resource utilization and     work status of patients with ankylosing spondylitis undergoing treatment with etanercept by     comparing study evaluations with the baseline evaluations in the ASCEND     (0881A3-402)(NCT00247962) study.   "
195873|NCT00410059|"     The goal of this clinical research study is to learn if erlotinib hydrochloride (OSI-774,     Tarceva®) can help to control NSCLC. The safety of this drug will also be studied, as well as     the drug's effect on different cells in the body and the participants' overall response.   "
195874|NCT00410072|"     The purpose of this study is to compare the effectiveness of entecavir plus tenofovir     combination therapy with that of entecavir monotherapy. Safety will also be studied.   "
195875|NCT00410085|"     Nitrogen-oxide (NO) plays an important role for blood pressure regulation, renal     hemodynamics, and the renal excretion of sodium. NO is synthesized from L-arginine in the     vascular endothelium and have a very short half-life in plasma and is therefore very     difficult to measure directly.      L-mono-methyl-L-arginine (L-NMMA) is an analogue to L-arginine and a competitive inhibitor of     NO, and therefore can be used to study the effect of NO on the circulation. In normal     subjects, infusion of L-NMMA will cause an increase in blood pressure, decreased renal     plasma-flow, decreased glomerular filtration rate, and a decreased excretion of sodium.      Hypothesis: Patients with obstructive sleep apnea has a decreased activity in the NO-system.     This is contributing to the hypertension often seen in these patients. Decreased activity in     the NO-system can be revealed by diminished fall in renal hemodynamic and sodium excretion     after infusion of L-NMMA.   "
195876|NCT00410098|"     Cold and dry air induce exercise induced asthma. Yoga training may improve lung function     tests. Bikram Yoga (heat 39 degree Celsius and humidity 60%)training may improve both lung     function tests and bronchial hyperreactivity (to exercise and adenosine 5'monophosphate).   "
195877|NCT00410111|"     Septic encephalopathy is an important complication of sepsis. Why some patients with sepsis     develop septic encephalopathy is unknown. We will investigate whether patients who develop     this condition have different patterns of cerebrovascular reactivity and whether it is     possible to predict the development of septic encephalopathy from early measurements of     cerebral perfusion or from the EEG. We will specifically test the hypotheses that septic     encephalopathy may not be predicted by changes in the EEG, and that cerebrovascular     autoregulation is not dysfunctional in septic encephalopathy.   "
195878|NCT00410124|"     To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic     carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.   "
195879|NCT00410137|"     prospective longitudinal measurements of nutritional status parameters (body composition by     BIA, anthropometry and biochemical indexes), inflammatory response (CRP, inflammatory     cytokines (IL-1, IL-6, IL-10),IGF-1, leptin and NOx blood levels) and morbidity and mortality     data collection over 2 year period in patients receiving chronic hemodialysis.   "
195880|NCT00410150|"     The purpose of this study is to investigate whether heliox-powered albuterol nebulizer     therapy will result in reduced inpatient length of stay in children hospitalized with acute     asthma exacerbations.   "
195881|NCT00410163|"     To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with     chemotherapy in previously untreated patients with B-CLL   "
195882|NCT00410176|"     The proposed study will evaluate whether the use of non-pharmaceutical methods, such as     surgical masks, isolation of patients and personal hygiene, are acceptable and effective in     preventing the spread of influenza within the family.This will be achieved by conducting a     randomized, controlled, unblinded, clinical trial. Family members of an index case with     influenza like illness, will be randomly allocated to two groups. In the intervention group,     family members will receive comprehensive guidance about sanitation and hygiene, as well as     surgical masks to wear whenever in close contact (3 feet / 1 meter) with the index case. In     addition, they will be asked to isolate the index case as much as possible. In the control     group, family members will receive only standard guidance about sanitation and hygiene     relevant for reducing the transmission of influenza. The primary end-point of the study will     be secondary infection of influenza of at least one of the family members in order to asses     the efficacy of the interventions. In addition, the compliance to those interventions will be     evaluated.      The study hypothesis is that use of non-pharmaceutical methods will be acceptable and will     reduce the secondary infection rate among them by 50%.   "
195883|NCT00410189|"     Primary Objective:        -  To determine the 8 week progression-free survival rate (i.e. disease control rate) in          patients with advanced NSCLC who have failed at least one prior chemotherapy regimen.      Secondary Objectives:        -  Determine the overall response rate        -  Determine the overall survival        -  Determine the time to disease progression        -  Assess the safety/toxicity of the study treatment        -  Assess biomarker modulation in the tumor tissue and serum samples from the treatment        -  Assess plasma and intra-tumor concentrations of study treatment   "
195884|NCT00410202|"     The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir     combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine   "
195885|NCT00410215|"     Colon cleansing prior to colonoscopy is critically important to ensure effective colonoscopy     for colon cancer screening, which is now widespread in North America. Currently available     colon cleansing agents are limited either by potential safety concerns or significant     limitations in the ability of patients to tolerate the preparation. Pico-salax has recently     been introduced in Canada as an alternative agent and is being used more and more widely     despite an almost complete lack of clinical data supporting efficacy and safety. This study     will establish the relative efficacy and patient tolerability of this agent and its safety     profile. This is a very important, practical issue which continues to challenge     gastroenterologists, surgeons, internists, family doctors and thousands of their patients in     Canada on a daily basis.      Anecdotal evidence suggests that the efficacy of pico-salax when used as a sole agent may not     be as efficacious as oral sodium phosphate. Hence, our hypothesis is that the combination of     pico-salax and bisacodyl will provide the most efficacious bowel preparation in comparison     with oral sodium phosphate and pico-salax alone, while being equally if not better tolerated.   "
195886|NCT00410228|"     This study will evaluate the safety and tolerability of ascending single oral doses of AHT956     in healthy subjects   "
195964|NCT00411268|"     The purpose of this open-label, extension study is to characterize the safety, effectiveness,     and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone     slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain.   "
195887|NCT00410241|"     This study will examine genome sequencing in clinical research. Genome sequencing is a     process in which researchers analyze (or sequence) part or all of the genome from a single     person. The human genome is the material in cells that includes thousands of genes. Gene     changes that cause or contribute to disease can be passed on from one generation to the next.     This study first focuses on heart disease. Later, researchers hope to study other conditions     and genes, with the eventual goal of sequencing most or all of participants genes.      Participants ages 45 to 65 years of age and who do not smoke, may be eligible for this study.     Patients will come to the NIH Clinical Research Center for an initial study to last about     half a day. They will donate a blood sample and complete a short survey. Then they will meet     the genetic counselor to learn more about genome sequencing. Those who join the study will     undergo the following procedures and evaluations:        -  Family history and medical history.        -  Measurement of height and blood pressure.        -  Noninvasive heart tests, including electrocardiogram and echocardiogram.        -  Drawing of about 3 ounces of blood (5 to 6 tablespoons); part of the blood sample will          be used for research and another part for clinical testing.        -  Multidetector computed tomography (CT), a test to measure coronary artery calcification,          that is, condition of inflexibility.      Each patient will receive a letter with results of the clinical laboratory values and     evaluations. There will be recommendations for follow-up with the patient s doctors. Risks in     this study include exposure to radiation from the CT test. The radiation amount used is about     the same that a person normally receives from natural sources, such as from the sun, outer     space, and radioactive materials found naturally in the earth s air and soil. Another slight     risk involves reactions to a contrast agent that may be used in the echocardiogram. Side     effects can be headache, nausea or vomiting, a warm sensation, and dizziness.      With the samples that patients provide, researchers will start by sequencing about 400 genes     related to heart disease. Analysis will take months to complete. Genome sequencing is     difficult to do, and researchers have much to learn about the genes they sequence and the     gene changes they find. If the researchers find gene changes that are important to the health     of a participant, they will contact that participant and give him/her the choice of learning     such results.      This study may or may not have a direct benefit for participants. Patients would get free     clinical testing for cholesterol, diabetes, and other conditions, as well as information     about gene changes. Knowledge gained will benefit people in the future as researchers learn     about the relationship between gene changes and health.   "
195888|NCT00410254|"     To evaluate the potential PK interaction of multiple oral doses of HCV-796 and a single oral     dose of midazolam when coadministered to healthy subjects.   "
195889|NCT00410267|"     Selective laser trabeculoplasty (SLT) is a new alternative to anti-glaucoma medications for     the treatment of primary open angle glaucoma. After SLT, many patients experience mild to     moderate inflammation inside the eye - specifically in the front chamber of the eye (the part     in front of the colored part of the eye). This mild front chamber reaction is typically     treated with anti-inflammatory agents such as corticosteroids and nonsteroidal     anti-inflammatory agents (NSAIDs). Some physicians do not use these agents as they feel they     may interfere with the way the laser works to treat glaucoma. Topical (applied to the     surface) corticosteroids can cause an increase in the pressure of the eye (intraocular     pressure or IOP), cataract formation, or a possible increase in infection with long-term use.     These side effects have not been reported to occur with NSAIDs, which are effective in     controlling pain after SLT and reducing signs of inflammation such as irritation, swelling,     tenderness, and soreness.      This research study will compare an NSAID, ketorolac tromethamine 0.4% (Acular LS), with a     corticosteroid, prednisolone acetate 1% (Pred Forte), and with a placebo, which contains no     active medicine (Refresh Tears). Ketorolac tromethamine 0.4%, prednisolone acetate 1%, and     Refresh Tears are all FDA (Food and Drug Administration) approved for use in inflammation     after surgery.   "
195890|NCT00410280|"     Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a     subject with mild asthma inhaling an allergen.   "
195907|NCT00410501|"     This study will evaluate the interaction potential between indacaterol and ketoconazole (a     potent CYP3A inhibitor) in healthy adult subjects.   "
195908|NCT00410514|"     This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to     placebo.   "
195891|NCT00410293|"     Diagnostic uncertainty in patients with complaints of shortness of breath presenting to the     Emergency Department of a hospital may delay treatment and proper care. In patients with     shortness of breath due to heart failure increased plasma levels of NT-pro-B-type natriuretic     peptide (NT-proBNP) can be demonstrated. The use of NT-proBNP as a biomarker for heart     failure in patients presenting to the emergency department with dyspnea might improve care     and reduce length of hospital stay.      To investigate the effect of NT-proBNP testing on patient care and time to discharge the     NT-proBNP test will be randomized. In patients in the study group, the NT-proBNP plasma level     is determined at admission and the physician in charge will immediately receive the result of     the test. In patients in the control group blood will be sampled but the physician will     recieve no information on the NT-proBNP plasma level.      In our study we will investigate the effect of introduction of NT-proBNP as biomarker for     heart failure on treatment, time to discharge and costs.   "
195892|NCT00410306|"     This is an observational study with a drug called Nebido, a new testosterone replacement     therapy, which is available for the treatment of male hypogonadism. The benefit and safety of     Nebido have already been thoroughly evaluated through well controlled clinical trials. The     main purpose of this observational study is to confirm the established safety profile of     Nebido in daily clinical practice.   "
195893|NCT00410319|"     The purpose of this study is to compare a specific fear-reducing information with     symptom-based exercise   "
195894|NCT00410332|"     Tonsillectomy is one the most common procedures in ear, nose and throat (ENT) medicine.     Following surgery patients suffer from severe pain and difficulty on swallowing, while     analgesic treatment has limited efficacy and potential adverse effects such as increased     bleeding with NSAIDs. Traumeel S is a homeopathic complex remedy used primarily in Europe for     the treatment of pain and inflammation. It contains a number of plants and minerals at high     dilutions (between 1x10-2 to 1x10-8), and has been shown to exhibit anti-inflammatory     properties such as cytokine inhibition in human T cells, monocytes and gut epithelial cells.     Clinical studies have found Traumeel S reduces post-chemotherapy stomatitis, as well as     post-surgical inflammation and pain following orthopedic procedures.      The purpose of this study is to examine the effect of Traumeel S on post-tonsillectomy pain     in adult patients. The study group will consist of 20 patients age 18 years of age and older     following elective tonsillectomy. These patients will be randomly assigned to receive     treatment with either true Traumeel S remedies or placebo. One ampule of Traumeel S (or     placebo) will be sprayed over the resected area immediately following surgery. Two Traumeel S     (or placebo) tablets will be taken subsequently 4 times daily (Total: 8 tablets per day)until     no analgesics are required for 2 consecutive days, or until Day 14 (whichever comes first).     Patients will be allowed to take dipyrone (Optalgin) 500mg tablets on an as-needed basis, for     up to 14 days postoperatively. At the end of this period, a thorough ENT examination will be     done.      The primary parameter to be evaluated in the study will be postoperative pain, as registered     on a numerical pain rating scale (NRS), to be filled prior to surgery. In the post-anesthesia     care unit (PACA) the NRS will be filled out again, this time for pain at rest and then again     for pain upon swallowing - at 1, 2, 3,4 and 24 hours postoperatively. Secondary parameters to     be evaluated are: analgesic use (dipyrone); post-operative bleeding (quantified on a scale of     1-4); nocturnal awakenings; time to resumption of eating and return to normal activity;     cytokine levels (CRP, IL-6) at 36 hours postoperative; and side effects of the treatment.   "
196007|NCT00411359|"     The purpose of this study is to determine whether cardiac rehabilitation is a successful     treatment for refractory angina, in relation to improvements in cardiovascular risk factors,     physical ability, symptomology, quality of life and psychological morbidity.   "
195895|NCT00410345|"     Induction of midtrimester abortion includes cervical ripening and then contraction to induce     uterine evacuation. There are several protocols, but most of them include using     prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and     limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug     and been used for induction of abortion in first and second trimesters abortions. The aim of     this study is to explore the effectiveness of Mifepristone for cervical ripening before high     dose Oxytocin drip.   "
195896|NCT00410358|"     This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in     Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days,     to adult patients with advanced solid tumors who have progressed despite standard therapy or     for whom standard systemic therapy does not exist.   "
195897|NCT00410371|"     This study intends to compare the pharmacokinetic characteristics, safety and tolerability of     two formulations of lamotrigine in healthy male and female volunteers   "
195898|NCT00410384|"     The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on     quality of life of two different doses of belimumab administered in addition to standard     therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE)     disease.   "
195899|NCT00410397|"     Low back pain (LBP) is a common problem in the adult population with many approaches to     treatment, but no clear answer. One of the causes of LBP, musculoskeletal pain, can be     triggered by spasm of the deep muscles of the back and pelvis. This study, therefore, focuses     on treating pelvic muscle pain as a way of lessening LBP.   "
195900|NCT00410410|"     The purpose of this clinical research study is to learn if abatacept can improve signs and     symptoms of active ulcerative colitis in patients who have not had an adequate response to     other therapies. The safety of this treatment will also be studied   "
195901|NCT00410423|"     Based on what is known about it's mechanism of action, bortezomib is presumed to make other     chemotherapy drugs work better. This study examines the use of bortezomib in combination with     an already effective chemotherapy regimen that is used to treat leukemias that have relapsed     or been refractory to treatment.   "
195902|NCT00410436|"     The purpose of the READI tiral is to examine the effects of resistance training (weight     training) on the blood sugar control of aerobically active individuals with Type 1 Diabetes.   "
195903|NCT00410449|"     Complications of hemodialysis access are the most frequent single reason for hospitalization     among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in     patients with diabetes, is a state of increased oxidative stress. The central hypothesis to     be tested by this project is that oxidative stress is a major (and modifiable) trigger for     vascular access complications. We hope to slow or reduce rates of stenosis, thrombosis and     access complications by giving Vitamin E supplementation to patients being treated by     hemodialysis.   "
195904|NCT00410462|"     RATIONALE: Drugs used in chemotherapy, such as brostallicin and doxorubicin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing.      PURPOSE: This randomized phase II trial is studying the side effects and how well     brostallicin or doxorubicin works as first-line therapy in treating patients with relapsed,     refractory, or metastatic soft tissue sarcoma.   "
195905|NCT00410475|"     Researchers at the National Cancer Institute and the University of Minnesota have followed a     nationwide cohort of 146,022 radiologic technologists since 1982 (Boice 1992; Doody 1998;     Mohan 2003; Sigurdson 2003). This is one of the largest cohorts of medical radiation workers     studied to date (Yoshinaga 2003)and the only one with substantial numbers of women (73%     female), extensive covariate data, both incident and death outcomes, and estimated     occupational radiation doses. The overall study objectives are to: quantify radiation     dose-response for cancers of the breast, thyroid, and other radiogenic sites; assess cancer     risks associated with genotypic, phenotypic, or other biologically measurable factors; and     determine if genetic variation modifies radiation-related cancer risks.      More than 110,000 technologists completed at least one of three comprehensive questionnaire     surveys administered over the last 20 years and 18,500 are deceased. The First Survey was     mailed during 1984-1989 to 132,454 known living radiologic technologists, of whom 90,305     (68%) completed the survey (Boice 1992). The Second Survey was mailed during 1993-1998 to     126,628 known living technologists, of whom 90,972 (72%) completed the questionnaire     (Sigurdson2003). Both surveys included detailed questions about employment as a radiologic     technologist, family history of cancer, reproductive history, height, weight, other cancer     risk factors (such as alcohol and tobacco use), history of personal diagnostic and     therapeutic medical radiation procedures, and information on cancer and other health     outcomes. A third follow-up of this cohort was recently completed. During 2003-2005, the     Third Survey was mailed or administered by telephone to 101,694 living cohort members who had     completed at least one of the two previous surveys; 73,838 technologists (73%) completed the     survey. This questionnaire elicited information on medical outcomes to assess     radiation-related risks, detailed calendar-specific employment data to refine the     occupational ionizing radiation dose estimates, and behavioral and residential histories for     estimating lifetime ultraviolet (UV) radiation exposures.      The large number of women with estimates of cumulative radiation dose to specific organs     (e.g. breast) (Simon 2006; see Figure 7 and Table 9) offers at are opportunity to study     effects of low-dose radiation exposure on breast and thyroid cancers, the two most sensitive     organ sites for radiation carcinogenesis in women.. We are not aware of any other study     population in which both quantified radiation doses and biospecimens are available for     individuals with protracted low-dose ionizing radiation exposures. Incorporation of     assessment of the role of genetic polymorphisms and molecular variants in DNA repair and     other genetic pathways that may be functionally important in radiation carcinogenesis would     provide initial results on the possible role of genetic factors in the cancer-radiation     relationship. Because large numbers of women are exposed to ubiquitous low-dose radiation     from occupational, medical, and environmental sources, the presence of radiation-sensitive     genetic variants that influence the risk of breast and other cancers would have important     public health implications.   "
196091|NCT00413426|"     This purpose of this study is to compare the how the body changes the blood level of a single     dose of darifenacin when given as 7.5 mg modified release tablet and the modified release     liquid suspension (1.5 mg/ml) under fasted and fed conditions in healthy subjects.   "
195909|NCT00410527|"     This study will compare two treatment strategies (standard versus short-course antibiotic     therapy) for preventing resistant bacterial infection in patients in the intensive care unit     (ICU). ICUs are the most frequently identified source of hospital-acquired infections. This     study will examine the effectiveness of 3 days of antibiotic treatment in reducing the risk     of developing antimicrobial-resistant bacteria as compared with standard antibiotic therapy     of at least 8 days. It will also determine whether short-course therapy can reduce the     duration and costs of ICU and hospital stays, of antibiotic treatment, and of costs involving     treatment of infection-related problems.      Patients of participating institutions who are in the ICU may be eligible for this study.     Candidates must be 18 years of age or older. They must have been in the hospital for at least     3 days, developed new pulmonary infiltrates (fluid or cells in the airspaces of the lungs)     during their ICU stay and must be at low risk of having pneumonia.      Participants on short-course therapy take antibiotic for 3 days; those receiving standard     therapy take antibiotic for at least 8 days. Both groups receive the treatment intravenously     (through a vein). Sputum specimens are collected at baseline (before starting therapy) and on     days 3, 10, and 28. Throat culture specimens are obtained at baseline and on days 3, 10, and     28. Nasal and anal or stool samples are collected at baseline and on days 10 and 28. Cultures     of respiratory specimens obtained throughout the study period are examined for evidence of     antimicrobial-resistant bacteria or the isolation of a potential pathogen. All patients are     followed for 28 days after enrollment or until discharge from the hospital.   "
195910|NCT00410540|"     The purpose of this study was to demonstrate the clinical equivalence of hydromorphone and     morphine (immediate-release [IR] and sustained-release [SR] formulations) using the worst     pain in the past 24 hours item of the Brief Pain Inventory (BPI). The secondary objective of     this study was to compare hydromorphone and morphine in the following variables: other pain     measures, various questionnaires, and safety and tolerability variables.   "
195911|NCT00410553|"     This phase I trial is studying the side effects and best dose of eribulin mesylate and     gemcitabine hydrochloride in treating patients with metastatic or unresectable solid tumors.     Drugs used in chemotherapy, such as eribulin mesylate and gemcitabine hydrochloride, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells.   "
195912|NCT00410566|"     The purpose of this study is to determine the safe range of single doses of rhASM     administered to adults with ASM deficiency.   "
196008|NCT00411372|"     This study will last for approximately 8 weeks and will involve 4 visits. The study is being     carried out to validate a shortness of breath questionnaire   "
195913|NCT00410579|"     RATIONALE: Learning about quality of life, symptoms, and health behaviors in colorectal     cancer survivors may help to determine the long-term effects of colon and rectal cancer     treatments and may help to improve the quality of life for future cancer survivors.      PURPOSE: This clinical trial is looking at patient-reported outcomes in long-term survivors     of colon and rectal cancers.   "
195914|NCT00410592|"     This study will be conducted in order to determine safety and efficacy esomeprazole,     lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and     women of Hispanic origin who have GERD.   "
195915|NCT00410605|"     This phase II trial is studying how well giving bevacizumab together with lenalidomide and     dexamethasone works in treating patients with relapsed or refractory stage II or stage III     multiple myeloma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Bevacizumab and     lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer.     Dexamethasone may stimulate the immune system in different ways and stop cancer cells from     growing. Giving bevacizumab together with lenalidomide and dexamethasone may kill more cancer     cells.   "
195916|NCT00410618|"     RATIONALE: Learning about the long-term effects of chemotherapy and radiation therapy on     brain function may help doctors plan cancer treatments.      PURPOSE: This clinical trial is looking at the neurological effects of chemotherapy and     radiation therapy in patients with colon cancer.   "
195917|NCT00410631|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving combination     chemotherapy may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill     tumor cells. An autologous stem cell transplant may be able to replace blood-forming cells     that were destroyed by chemotherapy and radiation therapy. This may allow more chemotherapy     to be given so that more tumor cells are killed. Sometimes, after surgery, the tumor may not     need more treatment until it progresses. In this case, observation may be sufficient. It is     not yet known whether observation is more effective than combination chemotherapy, radiation     therapy, and/or autologous stem cell transplant in treating neuroblastoma.      PURPOSE: This randomized phase III and phase IV trial is studying observation, combination     chemotherapy, radiation therapy, and/or autologous stem cell transplant to compare how well     they work in treating young patients with neuroblastoma.   "
195918|NCT00410644|"     The purpose of this repeated dose study is to develop recommended dosing information for     initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain     converting from other strong oral or transdermal opioids. It will also assist in the     development of a recommended starting dose by which patients can be titrated to an     appropriate maintenance dose of OROS Hydromorphone HCI. The safety profile for OROS     Hydromorphone HCI will also be evaluated.   "
195919|NCT00410657|"     RATIONALE: Alemtuzumab and glucocorticoids, such as prednisone or methylprednisolone, may be     an effective treatment for acute graft-versus-host disease caused by a donor stem cell     transplant.      PURPOSE: This phase II trial is studying how well giving alemtuzumab together with     glucocorticoids works in treating newly diagnosed acute graft-versus-host disease in patients     who have undergone donor stem cell transplant.   "
195931|NCT00410813|"     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This randomized phase II trial is studying two different schedules of dasatinib to     compare how well they work in treating patients with stage IV breast cancer that has spread     to the bone.   "
196092|NCT00413439|"     Patients who undergo chemotherapy for leukemia will receive study medication for prevention     of fungal infections. The study investigates the safety and tolerability of two different     dosages, the efficacy in prevention of fungal diseases.   "
195920|NCT00410670|"     This pilot study, conducted by the National Cancer Institute and the Massachusetts General     Hospital, will investigate genetic factors that contribute to the development of chordoma in     people from some families. Chordoma is a very rare, potentially fatal, slow-growing bone     tumor derived from remnants of embryonic material. This study will determine the feasibility     of conducting a larger study aimed at identifying new families with multiple members affected     by chordoma to study the genetic basis of the disease.      English-speaking persons diagnosed with chordoma when they were 18 years of age or younger     and who were treated at the Massachusetts General Hospital Department of Radiation Oncology     between 1988 and the end of the study period may be eligible for this protocol. The age range     of these patients is currently from about 5 months to 33 years.      Patients (or parents of minor patients) will be mailed a packet with instructions for     completing the following procedures at home:        -  Provide permission for researchers to obtain medical records relating to the patient's          chordoma and any other serious medical conditions he or she has had, and to obtain a          piece of the patient's stored tumor tissue.        -  Complete a questionnaire about the patient's close blood relatives, including parents,          brothers, sisters, and any more distant relatives who have had chordoma or a cancer or          tumor which started in the brain or spine. The questionnaire will also include          demographic information, such as education, marital status, ethnicity, religion, and          household income.        -  Collect two samples of cheek cells (only from patients 6 years and older). Patients'          packets include instructions and materials for collecting the cells. Parents of children          6 to 9 years old will collect cells from the child's mouth using a sterile soft-bristled          brush contained in a tube. They will brush the inside of the child's cheek with the          brush for about 30 seconds and then place the brush back in the tube. They will repeat          this procedure with a second brush. Patients 10 years of age and older will rinse their          mouth for about 45 seconds with a mouthwash provided in their packets and then spit the          mouthwash into a collection container. They will repeat the procedure several hours          later.      All participants will return the signed permission forms, questionnaires, and cheek cell     samples to the researchers in a pre-addressed stamped envelope, which is also provided in the     packet.   "
195921|NCT00410683|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation     therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known     whether giving radiation therapy after surgery is more effective than no radiation therapy in     treating patients with non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works compared to no radiation therapy in treating patients with non-small cell lung cancer     that has been completely removed by surgery.   "
195922|NCT00410696|"     The primary objective of the study is to evaluate the efficacy and the safety of     pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral     stem cell reinfusion.   "
195923|NCT00410709|"     This is an open label, single center, single dose PK study of NatrOVA Creme Rinse (1%), an     investigational treatment for head lice and nits, in normal, healthy infants.   "
195924|NCT00410722|"     To determine if tree nuts (Almonds, Hazelnuts, Pistachios, Peanuts, Macadamia nuts, Pecans,     Walnuts and Cashews) improve glycemic control in type 2 diabetes, as assessed by HbA1c and     serum fructosamine, and to assess whether these outcomes relate to improvements in     cardiovascular health (i.e. plasma lipids and measures of oxidative stress, inflammatory     biomarkers and nitric oxide generation). The investigators have found that nuts tend to     reduce the glycemic index of bread and have little effect of raising blood glucose on their     own. Therefore the investigators believe that they would be ideal foods to displace high     glycemic foods from the diet and lower the dietary glycemic load. This will result in     improved blood glucose control in type 2 diabetes, with additional benefits on coronary heart     disease risk factors due to other effects of nuts.   "
195925|NCT00410735|"     To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a     double-blind, randomized, placebo-controlled, parallel group, multi-center study   "
195926|NCT00410748|"     The purpose of study was to characterize the safety and tolerability of long-term repeated     dosing of OROS hydromorphone controlled release tablets (8,16,32, and 64 mg) in patients with     chronic cancer pain or chronic non-malignant pain.   "
195927|NCT00410761|"     The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer     patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body,     about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.   "
195928|NCT00410774|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of     pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine and bevacizumab     after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase I/II trial is studying the side effects of gemcitabine and bevacizumab     and to see how well they work in treating patients with pancreatic cancer that has been     completely removed by surgery.   "
195929|NCT00410787|"     The primary purpose of this study was to characterize the pain control achieved with     long-term repeated dosing of OROS hydromorphone (slow release) in patients with chronic     cancer pain and the secondary purpose was to characterize the effects of pain on the     patients' quality of life with long-term, repeated dosing of OROS hydromorphone (slow     release) taken by patients with chronic cancer pain.   "
195930|NCT00410800|"     The Pima Indians have the highest reported prevalence of NIDDM of any population in the     world. Within this population, it is possible to identify subgroups of individuals at a     particularly high risk for NIDDM. This project examines whether defects in insulin secretion     contribute to the higher risk of NIDDM in these subgroups and whether they progress over the     course of the disease.      Healthy Pima men and women at high risk for NIDDM including individuals in the following 3     groups will be recruited: 1)persons whose mothers and/or father developed diabetes at an     early age (< 35 y); 2) persons whose mothers were diabetic during pregnancy; and 3) persons     whose birthweight was < 2500 g. These individuals, as well as subjects with none of the above     risk factors and a group of non-Pima controls, will be admitted to the NIH Clinical Research     Unit at Phoenix Indian Medical Center for the following series of studies. Body composition     will be determined by DXA scanning and by measuring the amount os visceral abdominal fat     using MRI. A 75-g oral glucose tolerance test and a 25-g intravenous glucose tolerance test     will be performed. Insulin action will be measured with a hyperinsulinemic-euglycemic glucose     clamp (insulin infusion: 40mU/m(2) min and insulin secretory responses to glucose will be     measured during a 5-step hyperglycemic glucose clamp immediately thereafter. Pima subjects     will be followed longitudinally after discharge from the unit and oral glucose tolerance     tests will be performed every three months. Individuals who transition from normal to     impaired glucose tolerance or impaired glucose tolerance to diabetic will be invited back to     the Clinical Research Center for repeat testing.      By comparing insulin secretion-glucose dose-response curves, it may be possible to discern     subtle defects in insulin secretion predisposing certain individuals to NIDDM. In addition,     comparison of the responses in the offspring of diabetic pregnancies with those in the     offspring of mothers who subsequently became diabetic may allow us to separate defects due to     genetic causes from those due to the intrauterine environment. Finally, studying subjects as     they progress from normal glucose tolerance to diabetes will test whether the defects in     insulin secretion are progressive and contribute to the development of NIDDM.   "
196093|NCT00413452|"     Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP     therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.   "
195932|NCT00410826|"     This randomized phase II trial is studying cisplatin and radiation therapy together with or     without erlotinib hydrochloride to compare how well they work in treating patients with stage     III or stage IV head and neck cancer. Drugs used in chemotherapy, such as cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Specialized radiation therapy that delivers a high dose of radiation     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It may also make tumor cells more sensitive to radiation therapy.     Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more     tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective     with or without erlotinib hydrochloride in treating head and neck cancer   "
195933|NCT00410839|"     An alpha-linolenic acid (ALA) rich diet in the Lyon Heart Study reduced sudden cardiac deaths     possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994). Since     then, there has been a growing interest in ALA as a cardioprotective nutrient. Much of the     interest has focused on the potential antiarrhythmic effect of ω-3 fatty acids, especially     the longer chain ω-3 fatty acids, DHA and EPA, derived from fish. We therefore concluded it     important to test whether the shorter chain ω-3 vegetable oil ALA also had antiarrhythmic     effects, since this might also explain the beneficial effects seen on cardiovascular     mortality in the Lyon Heart Study.   "
195934|NCT00410852|"     To evaluate the efficacy and safety of three insulin algorithms in medical ICU patients     (MICU).   "
195935|NCT00410865|"     Primary Objectives:        1. To determine the maximum tolerated dose and transduction efficiency of adenoviral          mediated wild type p53 gene transfer in premalignancies of the upper aerodigestive          tract.        2. To determine the efficacy of single agent adenoviral mediated wild type p53 gene          transfer in reversing oral premalignancies.   "
195936|NCT00410878|"     The purpose of this study was to characterize the steady-state pharmacokinetic (metabolism     and action) profile of OROS hydromorphone HCI (slow release) in patients who required opioid     therapy on a daily basis for chronic pain conditions. Patients stabilized on prior opioids     were converted to OROS hydromorphone slow release and titrated (slowly increased or     decreased) to adequate analgesia (pain relief). They were maintained at that dose for 4-10     days and had blood samples drawn over 24 hours on the last day of study.   "
195938|NCT00410904|"     This phase II trial is studying how well giving AZD2171 together with pemetrexed disodium     works in treating patients with relapsed non-small cell lung cancer. AZD2171 and pemetrexed     disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. AZD2171 may also stop the growth of tumor cells by blocking blood flow to the tumor.     Giving AZD2171 together with pemetrexed disodium may kill more tumor cells.   "
195939|NCT00410930|"     To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet     v1 and birch pollen licenced extract used for subcutaneous immunotherapy.   "
195940|NCT00410943|"     The purpose of this study was to characterize a safe and effective means of conversion and     titration to an appropriate dose of hydromorphone HCI, to demonstrate comparable efficacy of     OROS hydromorphone HCI SR (slow release) and hydromorphone HCI IR (immediate release)     following administration of approximately equivalent total daily doses and demonstrate a     significant dose-response relationship between OROS hydromorphone HCI SR (slow release) for     breakthrough pain medication use or alternatively, diary-based analgesic scores   "
195941|NCT00410956|"     RATIONALE: Drugs used in chemotherapy, such as floxuridine and dexamethasone, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy directly     into the arteries around the tumor together with bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving floxuridine and dexamethasone as a     hepatic arterial infusion together with bevacizumab works in treating patients with     unresectable primary liver cancer.   "
195942|NCT00410969|"     The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System     is able to quickly and conveniently cool patients who are comatose after resuscitation from     cardiac arrest.   "
195943|NCT00410982|"     The goal of this clinical research study is to find the highest tolerated dose of gemcitabine     that can be given with busulfan and melphalan. The safety of this drug combination will also     be studied.   "
195944|NCT00410995|"     The purpose of this study is to determine the effect of daily use of Naproxen (a commonly     used over-the-counter NSAID) on the physical performance of athletes, as measured by maximum     oxygen consumption.   "
195945|NCT00411021|"     A prospective cross-over randomized study aimed to test the hypothesis that local injury of     the endometrium increases the implantation rate in the successive cycle. Seventy IVF patients     will be randomly selected to undergo either endometrial biopsies or minimal cervical scratch     on days 8-10 and 21-23 of their cycle, preceding the IVF treatment. If not pregnant, the     women will continue for another IVF cycle, preceded by endometrial or cervical scratch     complimentary to their procedure in the first cycle. The main major outcomes will include     pregnancy rate, implantation rate, endometrial thickness, abortion rate, live births and     embryo quality.   "
195946|NCT00411034|"     The purpose of this repeated dose study is to develop recommended dosing information for     initiation of therapy with OROS Hydromorphone HCI (slow release) in patients with chronic     cancer pain converting from other strong oral or transdermal opioids. It will also assist in     the development of a recommended starting dose by which patients can be titrated to an     appropriate maintenance dose of OROS hydromorphone HCI (slow release). The safety profile for     OROS Hydromorphone HCI (slow release) will also be evaluated.   "
195947|NCT00411047|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with     previously untreated stage IIIB or stage IV non-small cell lung cancer.   "
195948|NCT00411060|"     Data involving orthopaedic conditions and rehabilitation aspects of musculoskeletal and     neuromuscular disorders will be collected and stored as part of the normal clinical care of     patients seen in the University of Florida (UF) and Shands Orthopaedics and Sports Medicine     Institute.   "
195949|NCT00411073|"     This is a study to assess the effects of darapladib on the cardiac conduction of the heart as     compared to placebo and moxifloxacin. This a four period crossover design with each period     lasting about 10 days. There will be a 7 to 10 day wash out in between each period.   "
195950|NCT00411086|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such     as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood.     Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell     lymphoma.      PURPOSE: This phase II trial is studying the side effects and how well giving rituximab     together with GM-CSF works in treating patients with newly diagnosed follicular B-cell     lymphoma.   "
195951|NCT00411099|"     This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50     mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week     double-blind phase and a 52-week open-label phase.   "
195952|NCT00411112|"     More than 20% of patients operated on for colon cancer without node metastasis will develop     visceral metastases. The purpose of the study is to determine sentinel lymph nodes with two     methods: blue injection and isotopic detection. Sentinel nodes will then be analyzed by     immunohistochemy to detect micrometastases. No adjuvant therapy will be proposed to the     patient if there are only node's micrometastases and survival will be analyzed in regard to     the presence of these micrometastasis.   "
195953|NCT00411125|"     This is a phase I study to analyze bioavailability and pharmacodynamic of two different     variants of oral salmon calcitonin (SMC021) in postmenopausal women   "
195988|NCT00405015|"     Cardiovascular disease is the leading cause of death in diabetic patients due to both a high     event rate and a worse outcome. A pharmacological intervention that reduces     ischemia-reperfusion-injury would improve the outcome of diabetic patients after a     cardiovascular event. In the present study, we will use annexinA5 scintigraphy to address the     following hypothesis:      Rosiglitazone reduces ischemia-reperfusion-injury in humans with insulin resistance.   "
195954|NCT00411138|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain     after surgery. It is not yet known whether giving chemotherapy together with radiation     therapy is more effective than giving radiation therapy alone in treating endometrial cancer.      PURPOSE: This randomized phase III trial is studying chemotherapy and radiation therapy to     see how well they work compared with radiation therapy alone in treating patients with     high-risk, stage I, stage II, or stage III endometrial cancer.   "
195955|NCT00411151|"     This trial will be conducted to evaluate the efficacy, safety, and tolerability of sunitinib     (sunitinib-malate) as a second-line palliative therapy in metastatic gastric cancer. Despite     the efforts in front-line therapy, second-line protocols have not yet been established in     randomized clinical trials for those patients. Although many patients are still in good     performance status and present with low tumor burden after failure of first-line     chemotherapy, they may clearly benefit from second-line treatment. Increasingly more     metachronic metastatic patients are urging for new platinum-free therapeutic options due to     the fast-growing use of (neo-) adjuvant platin-based protocols.      So far, only sparse data on chemotherapy are available after failure of platin-based     protocols. Nearly only irinotecan-containing combinations have properly been analyzed, and     produced excellent response rates and survival times of up to 30% and 7.6 months,     respectively. However, irinotecan has not been approved yet for this indication. In addition,     as irinotecan-containing regimens have been submitted for approval for first-line therapy,     second-line regimens in irinotecan-refractory patients have not been evaluated in any trial.     Thus, there is an urgent need to establish new second-line treatment options for both,     cisplatinum- or irinotecan-combination refractory patients with advanced or metastatic     gastric cancer.      Sunitinib inhibits the receptor tyrosine kinases (RTKs) involved in tumor proliferation and     angiogenesis, specifically the VEGFR, PDGFR, KIT, FLT-3, and RET. The VEGF pathway has been     shown to be a significant factor in metastatic gastric cancer. In gastric carcinoma cells,     VEGF ligands and its receptors are definitely involved in the process of tumor progression.     KDR and FLT-1 are expressed widely and VEGF stimulated KDR-positive tumor cell growth     directly. The ligand VEGF-C has also been shown to be involved in progression of human     gastric carcinoma, particularly via lymphangiogenesis. In addition, peritoneal metastases of     some cancers such as gastric cancers were largely dependent on VEGF. Therefore, patients with     chemo-refractory metastatic gastric cancer might benefit from VEGFR inhibitory therapy with     sunitinib.   "
195956|NCT00411164|"     The purpose of this study was to compare the analgesic (a drug that relieves pain)     effectiveness and safety of OROS hydromorphone HCI (slow release) 8 mg and 16 mg to placebo     (no drug) in patients with osteoarthritis (OA).   "
195957|NCT00411177|"     This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and     high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and     laboratory parameters, and required medications.      The investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration     may provide better outcome, less morbidity, higher quality of life, and lesser requirement of     medications.   "
195958|NCT00411190|"     Relacatib is being developed for the treatment of osteoporosis, osteoarthritis and possibly     other bone disorders. Recent results suggest that relacatib interacts with the way our bodies     metabolise drugs and so some drugs which are commonly prescribed to the intended target     patient population could be affected by giving relacatib at the same time. The purpose of     this study is to evaluate the effect of repeat dose administration of relacatib on the way     subjects bodies metabolise three commonly prescribed medications in the osteoarthritis     population: ibuprofen, acetaminophen, and atorvastatin.   "
195959|NCT00411203|"     Objective: Evidence indicates that the protein kinase C-PKC signaling cascade may be one of     the direct targets in treatment of mania. The aim of this study is to investigate whether the     PKC inhibitor-tamoxifen has anti-manic properties. Method: Bipolar subjects with manic/mixed     episode were randomly assigned to receive either tamoxifen (80mg/day) or identical placebo     tablets in 1:1 ratio for three weeks.   "
195960|NCT00411216|"     The purpose of this study is to determine whether exercises relieve the symptoms of dizziness     and imbalance in people with vestibular deficits and improves the ability to see clearly     during head movements. We hypothesize that the performance of specific adaptation and     substitution exercises will result in an improvement in visual acuity during head movements     while those patients performing placebo exercises will show no improvement.   "
195999|NCT00405184|"     This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in     patients with primary immune deficiency currently being treated with Intragam P. Eligible     patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven     cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly     intervals. Patients will be monitored on the study for up to 36 weeks.   "
195961|NCT00411229|"     Primary:        -  To demonstrate that capecitabine/oxaliplatin as adjuvant chemotherapy is superior to          observation alone in terms of 3 year disease-free survival (DFS) rate in          chemotherapy-naïve patients who underwent potentially curative resection for gastric          cancer.      Secondary:        -  To compare the overall survival of surgery and capecitabine/ oxaliplatin as adjuvant          therapy versus surgery alone. To evaluate the safety profile of capecitabine/oxaliplatin          adjuvant therapy.   "
195962|NCT00411242|"     This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50     mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week     double-blind phase and a 52-week open-label phase.   "
195963|NCT00411255|"     This research study will examine whether magnetic or electrical stimulation of the brain can     improve the involuntary closure of the eyelids in patients with blepharospasm or Meige     syndrome; conditions that belong to a group of neurological disorders called dystonias.     Blepharospasm and Meige syndrome cause excessive involuntary closure of the eyelids or     blinking. In an earlier study of patients with writer's cramp, which is another form of     dystonia, symptoms improved temporarily with brain stimulation.      Interested people 18 years of age or older with blepharospasm or Meige syndrome may be     eligible for this study. Candidates are screened with a medical history, physical examination     and a blink reflex test.      Participants undergo brain stimulation and evaluations before and after the stimulation to     test the response, as follows:      Procedures        -  Transcranial magnetic stimulation (TMS): A wire coil is held on the patient's scalp. A          brief electrical current is passed through the coil, creating a magnetic pulse that          stimulates the brain. The subject hears a click and may feel a pulling sensation on the          skin under the coil. There may be a twitch in the muscles of the face, arm or leg. The          subject may be asked to tense certain muscles slightly or perform other simple actions.          The effect of TMS on the muscles is detected with small metal disk electrodes taped to          the skin of the arms or legs. TMS is done on eight of the ten test days.        -  Repetitive TMS (rTMS): The same procedure as TMS, except repeated magnetic pulses are          delivered in short bursts. RTMS is done on eight of the ten test days.        -  Theta burst stimulation (TBS): A form of rTMS that involves short bursts of impulses.          TBS is done on four study days.        -  Cathodal transcranial DC stimulation (tDCS): Two conductive-rubber electrodes placed in          saline-soaked sponges are positioned over two areas of the head. A constant weak          electrical current flow is applied for 20 minutes. tDCS is done on two study days.      Evaluations        -  Physician observation: The subject's eyes are videotaped for 5 minutes before and after          each TMS session. A physician then counts how many times the subject blinked during the          5 minutes.        -  Questionnaire: Subjects are asked to rate their symptoms before and after brain          stimulation.        -  Electrophysiological test of the blink reflex: Wires are taped to the skin on the nose          and temple to record the eye movement during blinking. A thin plastic rod is placed on          the skin over the right e...   "
195965|NCT00411281|"     RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the     growth of abnormal cells, either by killing the cells or by stopping them from dividing.     Giving low-doses of cytarabine may be an effective treatment for Down syndrome and transient     myeloproliferative disorder. Sometimes the disease may not need treatment until it     progresses. In this case, observation may be sufficient.      PURPOSE: This phase III trial is studying low-dose cytarabine to see how well it works in     treating infants with Down syndrome and transient myeloproliferative disorder.   "
195966|NCT00411294|"     To examine the effect of ergocalciferol treatment on 25-hydroxyvitamin D and PTH levels in     patients with CKD stage 3 and 4   "
195967|NCT00411307|"     The purpose of this small study was to investigate the safety and effectiveness of OROS     hydromorphone HCI for the treatment of short-term, moderate to severe postoperative pain     following total knee replacement surgery.   "
195968|NCT00411320|"     Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The     causes of this phenomenon are currently unknown. The investigators will perform a number of     blood & breathing tests to try to discover the cause/s behind this phenomenon with the aim of     producing leads for further investigation and possible new treatments for smokers with     asthma.   "
195969|NCT00411333|"     The retinal vasculature changes dramatically in patients with diabetic retinopathy especially     between non-proliferative and proliferative disease. The retinal vasculature can be imaged     and quantified using special dyes. This study will test whether the pattern of the retinal     vasculature changes in patients with different levels of diabetic retinopathy can be     quantified using computerized image analysis. In addition, the study will evaluate whether     new drugs to treat diabetic retinopathy will be able to reverse these vascular changes.   "
195970|NCT00411346|"     The objective of this study was to investigate if a nurse-led telemonitoring programme is     effective and cost-effective in asthmatic outpatients, aged seven years and older.   "
195971|NCT00404794|"     This is a prospective randomized open-label pilot study to compare mycophenolate mofetil in     combination with corticosteroid treatment and tacrolimus in combination with corticosteroid     treatment in membranous lupus nephritis. The change in urine protein excretion will be the     primary outcome studied. The study duration will be 24 months for each patient.   "
195972|NCT00404807|"     The role of continuous positive airway pressure (CPAP) in cardiac function in patients with     CSA and OSA has been studied with varying results. Nevertheless, it is not clear whether CPAP     treatment for respiratory sleep disorders in CHF could slow down deterioration or improve the     cardiovascular function.      In an attempt to yield further insight into this subject, we undertook a multicentre study to     analyze the role of CPAP therapy (optimal vs sham) in the LVEF and in other cardiac     measurements in patients with CHF.Aim. We evaluated in a randomized multicentre placebo     (sham-CPAP) controlled study the effect of CPAP treatment on the left ventricle ejection     fraction (LVEF) among other cardiological related variables.   "
195973|NCT00404820|"     The aim of this study was to examine the effect of zoledronic acid and alendronate on bone     metabolism as measured by biomarkers in postmenopausal women with osteoporosis.   "
195974|NCT00404833|"     This is a prospective randomized open-label pilot study to investigate the effect of     mycophenolate mofetil treatment in patients with abnormal urine protein excretion due to     membranous nephropathy (MN) or focal segmental glomerulosclerosis (FSGS). The change in urine     protein excretion will be the primary outcome studied. The treatment regimen comprising     prednisolone and mycophenolate mofetil will be compared with prednisolone and chlorambucil in     MN, and compared with prednisolone in FSGS. The study duration will be 12 months for each     patient.   "
195975|NCT00404846|"     The purpose of this investigation is to evaluate the cognitive and behavioral effects of     Hyperbaric Oxygenation Therapy in children who present with a diagnosis of autism and other     developmental disabilities.   "
196094|NCT00413465|"     The purpose of the present protocol is to study whether endotoxemia will affect the renal     blood flow in type 2 diabetics and healthy volunteers.   "
195976|NCT00404859|"     Background By means of measurements of series of non-invasive inflammatory markers in exhaled     breath (condensate), a reflection of inflammatory processes and oxidative stress, can be     obtained. Thereby, these techniques could be important in monitoring asthma and CF lung     disease in children. Fractional exhaled nitric oxide (FeNO) and inflammatory markers in     exhaled breath condensate (EBC) reflect ongoing inflammation and oxidative stress in the     airways. These markers have a promising capacity for monitoring diagnoses of CF and asthma     lung disease.      Aim To study the course of inflammatory markers in time in children with asthma and CF, in     stable periods and during pulmonary exacerbations. In addition, we study the ability of     inflammatory markers to predict safe tapering of medical treatment in both populations.        1. To study the course of inflammatory markers in EBC during an exacerbation.        2. To study which IM are already elevated before a clinical exacerbation is evident and can          predict exacerbations in time.        3. To study which inflammatory markers can predict safe discontinuation of antibiotics in          children with CF, or tapering of inhaled corticosteroids in children with asthma.        4. To study the relationship between inflammatory markers in EBC, the severity and control          of CF and asthma, the symptoms and lung function within patients will be analysed.      Methods Children with CF (n=30) and children with asthma (n=40) were recruited included from     our outpatient clinic. During this longitudinal study patients visit the outpatient clinic     were followed–up for 12 months; every two months during one year. patients visited our     outpatient clinic. In addition to these standard visits, During exacerbations patients four     extra visits were planned during an exacerbation. were asked to visit the University Hospital     Maastricht four times. These additional visits were planned with a maximum of two times     during the study. By means of a home monitor, children were asked to assess measurements of     Besides measurements in the University Hospital, children measured forced expiratory volume     in one second (FEV1) at home using a home monitor, to record medication use, and, to record     presence and severity of pulmonary symptoms. Outcome parameters were: 1) FeNO assessment in     exhaled air, 2) inflammatory markers in EBC, 3) lung function parameters, 4) specific     questionnaires to assess asthma and CF control and severity, 5) data originating from the     home monitor.   "
195977|NCT00404872|"     Cardiovascular disease (CVD) affects millions of people in the United States; each year, more     people die from CVD than from any other disease. Individuals with low levels of n-3 fatty     acids and high levels of trans-fatty acids may have an increased risk of developing CVD. This     study will evaluate the link between fatty acids and the presence of CVD in older adults.   "
195978|NCT00404885|"     The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in     subjects with active non-infectious anterior uveitis   "
195989|NCT00405041|"     The objective of the study is to evaluate the efficacy of a neuroprotective dietary     supplement in patients suffering from herniated lumbar disc causing nerve root compression.   "
195990|NCT00405054|"     This study will evaluate MK0457 in patients with chronic myelogenous leukemia and     Philadelphia chromosome-positive acute lymphoblastic leukemia. Efficacy and safety will be     evaluated.   "
195991|NCT00405067|"     The main objectives of this study are to evaluate the efficacy and safety of combination     therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol     and other lipoproteins over 12 weeks of therapy.   "
195979|NCT00404898|"     The American Red Cross has funded a multidisciplinary, comprehensive evaluation and treatment     program for target individuals with suspected World Trade Center (WTC)-related health     problems. The populations served consist predominantly of a) local residents who were     impacted by the disperion of the WTC dusts and fumes, b) individuals involved in cleaning and     debris removal of local commercial spaces, and c) responders to the WTC collapse. These     populations are recruited from past and ongoing programs that we have developed as well as     from ongoing collaborations with community organizations that include: the Beyond Ground Zero     Network, 9/11 Environmental Action committee, and the WTC Residents Coalition. In addition,     there is collaboration with the Charles B. Wang Community Health Center and the centers     involved in the ongoing WTC Workers and Volunteer Medical Screening and Monitoring Program.     We would now like to access the data from this treatment program to create a NYU/Bellevue WTC     Health Impacts Research Registry to increase knowledge about the health effects of exposure     to World Trade Center dust.   "
195980|NCT00404911|"     This study will examine the effectiveness of a multiple family group mental health service     delivery strategy in improving mental health service use and outcome for urban, low income     children of color, ages 7-11 years old with disruptive behaviors and their families.   "
195981|NCT00404924|"     This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is     more effective than best supportive care alone, for the treatment of patients with non-small     cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal     Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug     in development that works in a different way to standard chemotherapy drugs. It targets the     growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour     may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour     may take to progress to a further stage. Approximately 930 patients will take part in this     study. It will be conducted in hospitals and clinics in North and South America, Europe and     Asia.   "
195982|NCT00404937|"     The purpose of this study is to compare the new formulation of Tobradex to the current     approved formulation   "
195983|NCT00404950|"     To determine whether intraoperative hyperglycemia potentiates renal injury in the setting of     cardiac surgery requiring cardiopulmonary bypass.   "
195984|NCT00404963|"     This study represents the first administration of GSK376501 in humans and the goal is to     evaluate its initial safety and tolerability. The way the human body processes GSK376501 will     also be determined.   "
195985|NCT00404976|"     Background:      Exhaled nitric oxide and inflammatory biomarkers in exhaled breath condensate may be useful     to diagnose and monitor childhood asthma. Their ability to indicate an asthma diagnosis, and     to assess asthma severity and control, is largely unknown.      Objective:      To study 1) the ability of exhaled nitric oxide and inflammatory markers in exhaled breath     condensate (nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor necrosis     factor-α, interleukin-2,-4,-5,-10, acidity) to discriminate between childhood asthma and     controls. 2) the ability of these biomarkers to indicate asthma severity and control.      Methods:      114 Children were included: 64 asthmatics (10.7±3.0 years, 67.2% atopic) and 50 controls     (10.0±0.4 years). Condensate was collected using a glass condenser   "
196000|NCT00405197|"     Background: During the 1990s, the prevalence of the metabolic syndrome in the Netherlands     ranged from 3% in women of 20-39 yrs to at least 33% in men 55 yrs and older and it is     expected to increasing. Prevention is therefore warranted. In this respect the amount and     type of fat in the diet deserves attention. Recently, an intervention study reported that a     diet high in mono-unsaturated fatty acids (MUFA) such as from olive oil, increased insulin     sensitivity in healthy subjects. However, additional beneficial effects can be expected from     the Mediterranean diet as a whole. Hypothesis: Replacing saturated fatty acids (SFA) by     mono-unsaturated fatty acids (MUFA) will improve hyperinsulinemia and dyslipidemia, and a     typical Mediterranean diet will even have more pronounced effects. Study objectives: To     investigate the impact of the Mediterranean diet, and especially the intake of MUFA, on     markers of the metabolic syndrome in high-risk subjects. Methods: The controlled dietary     intervention will include 60 subjects aged 40-65 years with moderate abdominal obesity. After     a run-in diet for 2 weeks they will be assigned randomly to receive one of the three diets     for a period of 8 weeks. Measurements of serum insulin concentration and other parameters     will be carried out at weeks 2 and 10. Expected results: Our study will provide information     on the role of MUFA and the expected beneficial impact of other factors of the Mediterranean     type of diet on the metabolic syndrome.   "
195986|NCT00404989|"     The purpose of the Antiretroviral Pregnancy Registry (Registry) is to detect any major     teratogenic effect involving any of the Registry drugs when administered to pregnant women.     Registration is voluntary and confidential with information obtained from the health care     provider. A Registry-assigned identifier allows for follow-up capability. Information on     subjects is provided to the Registry prospectively (prior to the outcome of pregnancy being     known) through their health care provider, with follow-up obtained from the health care     provider after the outcome is determined. Providers are strongly urged to enroll their     patients as early in pregnancy as possible to maximize the validity of the data. In addition,     the Registry is very interested in assembling a group of providers who are willing to make a     commitment to report all of their site's antiretroviral pregnancy exposures to the Registry,     thereby assuring all cases can be considered prospective. Providers are encouraged to contact     the Registry for more information about this group. The Registry is informed in its analysis     by other data, for example, retrospective reports and clinical studies.      Given the increasing number of medications and more aggressive approach to therapy, more HIV-     and hepatitis B-infected women may be treated during pregnancy or become pregnant while under     treatment. The paucity of data on use and infant outcomes of antiretroviral therapies during     pregnancy makes this Registry an essential component of the ongoing program of epidemiologic     studies of the safety of these therapies.      Each year the Registry has enrolled approximately 1300 pregnant women in the US exposed to     antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive     women who give birth to live infants annually in the US.   "
195987|NCT00405002|"     In this study the investigators aim to evaluate a new system dedicated to estimate the end     expiratory lung volume, by measuring the VO2-VCO2, during mechanical ventilation compared to     the helium dilution technique and the computed tomography (CT) scan.   "
195993|NCT00405093|"     Primary Objective: The aim of this study is to assess the effects of Aprotinin (an     antifibrinolytic drug used to reduce bleeding during cardiac surgery) on renal function in     patients undergoing surgery with use of hypothermic bypass and circulatory arrest for repair     of the thoracic aorta.      Secondary Objective: To compare the effects of Aprotinin and Amicar on major vascular     outcomes following thoracic aorta surgery with use of hypothermic bypass and circulatory     arrest.   "
195994|NCT00405106|"     To evaluate the effects of exam preparation on anxiety level, self perception, ocular     symptoms and oculomotor responses in myopes   "
195995|NCT00405119|"     Current treatment for gastroesophageal reflux disease (GERD) confirms an unmet need in     patients, based on slow onset of action and an inability to provide 24-hour gastric-acid     suppression. Clinical data on AH234844 demonstrates a rapid onset of action, high potency,     and prolonged duration of effect. The present study endeavors, in part, to compare     lavoltidine to two GERD drugs, NEXIUM and ranitidine.   "
195996|NCT00405145|"     This study aims improving the outcome after brain resective surgery of epileptic patients by     improving presurgical evaluations. In particular the specific goal is to evaluate the ability     of non invasive neuroimaging (functional magnetic resonance imaging and     electroencephalography) to provide presurgical maps of the functional areas of the brain and     of the epileptogenic networks.   "
195997|NCT00405158|"     The objective of the study was to test the hypothesis that acupuncture treatment hastens     recovery time from inflammatory symptoms of the breast during breastfeeding. 205 mothers with     210 cases of breast inflammation (commonly called mastitis) during breastfeeding were     randomly assigned to one of three treatment groups. There were two groups where acupuncture     was used and one without acupuncture. The mothers symptoms were recorded at the onset of     health care contact and daily until recovery. All care interventions given, including     antibiotic therapy, were monitored. Women who participated were asked to leave a breast milk     sample to test for bacterial growth. It was found that acupuncture did not shorten the     women's contacts with health care services but did improve their symptoms on contact days 3     and 4. It was seen in this study that only 15 % of women were prescribed antibiotics which     was a very low rate of prescription compared to USA, Canada, Australia, Turkey and New     Zealand where up to 100% are given antibiotics. Seven women (3.3% of those in the study)     developed a breast boil and this is a similar number to a study in Australia where many more     were treated by antibiotics. This could mean that many women throughout the world are given     antibiotics when in fact they may recover without them. This is an important finding in     relation to the fight against antibiotic resistant bacteria.   "
195998|NCT00405171|"     Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with     human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz     (EFV), are associated with increases in serum lipids. The investigators investigated whether     stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein     cholesterol, while keeping virologic control of HIV.   "
196095|NCT00413478|"     The objective of this study is to determine the safety and efficacy of Azacytidine in     fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and     T-cell prolymphocytic leukemia (T-PLL).   "
196001|NCT00405210|"     The purpose of the trial is to determine the most effective dose of BAy 46-9003 associated to     taxotere for first-line treatment of patient with prostatic cancer.      BAY 43-9006 (SORAFENIB) is a novel dual-action Raf kinase and VEGFR inhibitor, which is     orally available and has a favorable safety profile in patients with advanced solid tumors.     This, together with the antitumor activity observed after treatment with BAY 43-9006     (SORAFENIB), provides a rationale for further evaluation in patients with advanced cancer.     The recommended dose of BAY 43-9006 (SORAFENIB) for future studies is 400 mg bid as a     continuous dosing schedule.   "
196002|NCT00405236|"     Patients with COPD experience exacerbations that are a major cause of morbidity.     Exacerbations are associated with increased airway and systemic inflammation and those     experiencing frequent exacerbations demonstrate increased inflammation in the stable state.     Tiotropium has been shown to reduce exacerbation frequency and it might be postulated that     this is due to a reduction in inflammation. The study will compare airway inflammation and     exacerbation frequency in patients with COPD on tiotropium or placebo.   "
196003|NCT00405249|"     The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.   "
196004|NCT00405262|"     The efficacy of three postoperative pain management regimens will be compared in patients     undergoing Lefort I osteotomy or alveolar cleft repair with Iliac crest bone grafts (ICBG) to     determine the best way of managing postoperative pain.   "
196005|NCT00405275|"     Rheumatoid arthritis (RA) is a chronic inflammatory disease of the joints leading to joint     destruction, with significant long-term morbidity and mortality. Early treatment of RA     patients with disease-modifying antirheumatic drugs (DMARDs) significantly decreases these     complications. Methotrexate (MTX) is an excellent, economical first-line DMARD used to treat     a majority of RA patients. While most patients respond well to MTX, many continue to have     active disease. Therefore, understanding how to best treat RA patients with active disease     despite MTX therapy is critically important. Although a number of therapies with     significantly different economic implications have been shown to be effective when added to     MTX, no trial has directly compared active therapies. This study will compare therapeutic     strategies using two regimens with proven efficacy when added to MTX therapy; a)     hydroxychloroquine and sulfasalazine (cost ~ $1000 per year); b) the tumor necrosis factor     inhibitor, etanercept (cost ~ $12,000 per year).      We propose a bi-national multi-center randomized, double-blind equivalency trial comparing     (A) the strategy of initially adding hydroxychloroquine and sulfasalazine to MTX in patients     with active disease despite MTX, with a switch at 24 weeks to etanercept in nonresponders to     (B) a strategy of adding etanercept to MTX, with a switch to hydroxychloroquine and     sulfasalazine in nonresponders at 24 weeks. If we find that the strategy of first adding     hydroxychloroquine and sulfasalazine to MTX identifies a subset of responsive patients and     that there is no harm to nonresponders because of early rescue with etanercept, then this     less expensive option should become the standard treatment for MTX resistant patients.      Four hundred and fifty RA patients with active disease despite treatment with MTX as     indicated by a Disease Activity Score with 28 joints (DAS28) of >4.4 units will be     randomized. A DAS improvement of <1.2 (validated as clinically significant) at 24 weeks will     be used to identify early nonresponder who will switch therapy. Subjects with a DAS28     improvement of > 1.2 at 24 weeks will remain on their initial therapy. The primary endpoint     is the change of DAS 28 scores from baseline to 48 weeks. The secondary endpoint is     comparison of radiographic progression of disease at 48 weeks, as measured by the change in     Sharp score. Economic and functional outcomes will be assessed and a serum and DNA bank will     be established to evaluate potential biomarkers predictive of treatment response/toxicity and     disease progression. This trial will recruit 450 subjects over 40 months. At the end of the     48 week blinded active therapy portion of the trial, the blind will be broken and data will     be collected in an open fashion until all 450 patients have completed the 48 week portion of     the trial.   "
196006|NCT00405288|"     The purpose of this study is to evaluate the fetal safety of topical application of     Proctofoam-HC®, an antihemorrhoidal, in the third trimester of pregnancy.   "
196009|NCT00411385|"     This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of     albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon     alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic     hepatitis C, genotype 2/3 who are IFNa treatment naive.   "
196010|NCT00411398|"     This study is being conducted to evaluate the safety and effectiveness of memantine Add-On     treatment of patients who are currently taking an SNRI or SSRI and who remain anxious and     symptomatic despite treatment.      Secondary objectives of this study are:      •-to evaluate if there is an improvement in disability levels following memantine dosing      -to evaluate if there is an improvement in sleep quality following memantine dosing   "
196011|NCT00411411|"     We wish to evaluate the effect of long term treatment with a DPP-IV inhibitor on the function     of the incretin hormones      Hypothesis We hypothesize that that a gradual improvement in metabolic control induced by     DPP-IV inhibitor (Januvia®) treatment significantly ameliorates the impaired secretion and     potency of GLP-1 and leads to a restoration of the lost action of GIP.   "
196012|NCT00411424|"     The purpose of this study is to investigate the safety and tolerability of the new medication     ASK8007, and to study whether it has a beneficial effect on joint inflammation in patients     with rheumatoid arthritis.   "
196013|NCT00411437|"     The primary purpose of the trial is to show that tolterodine ER has no effect on memory and     other cognitive abilities in an elderly population   "
196014|NCT00411450|"     The primary objective is to estimate the effect of the human homolog of the Kirsten rat     sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue     on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving     second-line chemotherapy with panitumumab after failing first-line treatment.   "
196015|NCT00411463|"     Purpose of this study is to examine the effectiveness of an experimental psychotherapy (talk     therapy) for the treatment of bipolar II depression. The name of this psychotherapy is     Interpersonal and Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). Subjects will     be randomly assigned to receive either IPSRT-BPII or the medication Seroquel (quetiapine) to     manage their symptoms of bipolar II depression. Subjects will receive the assigned therapy     for up to 20 weeks.   "
196016|NCT00411489|"     The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in     the United States. Despite initial weight loss, some patients experience weight regain that     may be related to an increase in the size of the gastric pouch and/or stoma. A second     surgical procedure to reduce the size of the pouch and/or stoma is typically associated with     a higher risk of death or complications than the original gastric bypass procedure. This     study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a     means of producing weight loss in patients who have regained weight following gastric bypass.   "
196017|NCT00411515|"     The purpose of this prospectively randomized multicentre study was to prove the efficacy and     safety of mycophenolate mofetil (MMF) to preventing graft rejection and improvement of clear     graft survival following high-risk keratoplasty.      The patients of the MMF group receive MMF orally 2x1 g daily for 6 months. Endpoints were     immune reaction free and clear graft survival and the occurence of side-effects.   "
196018|NCT00411528|"     The objective of this study is to assess the response of patupilone plus prednisone compared     to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic     hormone refractory prostate cancer. Additionally, this study will assess the response on     measureable disease and the effects on patient-reported outcomes.   "
196019|NCT00411541|"     Studies in the 1970s and 1980s suggested that the outcome of childhood acute lymphoblastic     leukemia could be improved by intensification of conventional continuation chemotherapy with     pulses of vincristine sulfate and steroids. We aimed to investigate the efficacy and toxic     effects of vincristine-dexamethasone pulses as an addition to the continuation-therapy phase     in a large cohort of children with intermediate-risk disease who were treated with the BFM     treatment strategy   "
196020|NCT00411554|"     The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients     with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.   "
196021|NCT00411567|"     The purpose of this study is to investigate/assess the treatment of moderate to severe     asthmatics with inhaled corticosteroid.   "
196022|NCT00411580|"     This study will evaluate the safety and tolerability and Aß-specific antibody response of     CAD106 in patients with mild to moderate Alzheimer's Disease.      Patients also had a 2 year follow-up to assess disease progression where no drug was     administered.   "
196023|NCT00411593|"     Primary Objective      The primary objective of this phase I-II study is to evaluate:        -  Phase I: Assess the maximum tolerated dose (MTD) of bortezomib in a weekly schedule with          bevacizumab given every 3 weeks.        -  Phase II: Using the MTD established in phase I, assess efficacy of the combination as          indicated by progression-free survival.      Secondary Objectives      The secondary objectives of this study are to evaluate:        -  Response rates and duration of response        -  1 year survival        -  Overall survival        -  Qualitative and quantitative toxicity        -  Circulating endothelial cells (CECs) prior to treatment, prior to cycle 2, and/or at the          time of progression   "
196024|NCT00411606|"     An objective of this study is to standardize temperature values derived from thermograms of     the facial region. It is anticipated that the mean temperature of a defined region of     interest, such as the eyes, nose, or sinuses, might be useful for future applications.      The investigators will attempt to determine normal temperature ranges based on participants'     age and gender.   "
196025|NCT00411619|"     The purpose of the study is to evaluate the safety and potential side effects of everolimus     (an experimental drug) on a person with Tuberous Sclerosis Complex who also has been     diagnosed with a brain tumor (astrocytoma)      The hypothesis is that the drug will cause the tumor size to decrease, and may have     beneficial activity separate from effects on tumors in patients.   "
196026|NCT00411632|"     The goal of this clinical research study is to evaluate the effectiveness of Tarceva®     (OSI-774, erlotinib hydrochloride) in combination with Targretin® (bexarotene) in treating     NSCLC. The safety of this treatment will also be studied, as well as the treatment's effect     on different cells in the body and the participants' overall response.   "
196029|NCT00411671|"     Primary Objective:        -  To determine the 8 week progression-free survival rate (i.e. disease control rate) in          patients with advanced non-small cell lung cancer (NSCLC) who have failed at least one          prior chemotherapy regimen.      Secondary Objective:      The secondary objectives of this study will be to:        -  Determine the overall response rate        -  Determine the overall survival        -  Determine the time to disease progression        -  Assess the safety/toxicity of the study treatment        -  Assess biomarker modulation in the tumor tissue and serum samples from the treatment.        -  Assess plasma and intra-tumor concentrations of study treatment   "
196030|NCT00411684|"     The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing     pregnancy when taken 3 to 5 days after unprotected sexual intercourse.   "
196031|NCT00411697|"     The purpose of this study is to determine at 5 years of age the persistence of immunity to     hepatitis B that was conferred by infant vaccination with Infanrix hexa™.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
196032|NCT00411723|"     RTL1000 is a new agent that has not been previously tested in humans. It is thought that RTL     may specifically control the abnormal immune response or attack against the insulation on the     nerves that occurs in multiple sclerosis.      The purpose of this study is to evaluate the possible side effects of a single intravenous     dose of RTL1000 in subjects with multiple sclerosis. Some subjects will also be asked to     participate in one or both of two substudies, one to test blood samples to see how the body's     immune system responds after administration of RTL1000, and the other to test blood samples     to see how the body absorbs and eliminates the RTL1000.   "
196047|NCT00412841|"     This study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show     reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a     disease resulting from the loss of blood supply to the bones which can cause the bone to     collapse. The collapse of bone may require a surgical replacement of the joint and can be     disabling for life. Avascular necrosis is presently not preventable but research has shown     that lipid lowering drugs such as lipitor can reduce or prevent avascular necrosis in     animals. We therefore hypothesize that lipitor will reduce the incidence of avascular     necrosis in lupus patients taking high dose steroids.   "
196048|NCT00412854|"     This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and     Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and     immunogenicity.   "
196033|NCT00412646|"     The purpose of this randomized (patients are assigned different treatments based on chance),     placebo-controlled, dose-escalating trial is to evaluate the safety, tolerability and     efficacy of different doses of TMC125 twice daily ( b.i.d.) when added to an individually     optimized antiretroviral therapy (ART) for 48 weeks. Dose-escalation will be performed in two     stages. In the first stage approximately one hundred and eighty HIV-1 positive, three-class     ART experienced patients will be randomized to placebo, 400 or 800 mg of TMC125 b.i.d. In the     second stage, approximately seventy patients will be randomized to placebo, 800 or 1200 mg     TMC125 b.i.d. Stage 2 will be opened for enrollment after review of the available safety and     efficacy data for a specified number of patients and concurrence by the Data Safety and     Monitoring Board (DSMB). After all patients are treated for a period of 12 weeks, unblinding     for the sponsor will occur. The trial will continue in a single-blind fashion (sponsor     unblinded, but investigator and patient blinded) for up to 48 weeks. Upon completion of the     initial 48 weeks of treatment, patients deriving clinical benefit, in the opinion of the     investigator, will have the option to prolong the same treatment, in a single-blind setting     up to a maximum of 144 weeks.   "
196034|NCT00412659|"     The trial compares excision in the midline at surgery for pilonidal disease versus excision     lateral of the midline (Karydakis operation) at surgery for pilonidal disease by randomly     allocating patients with pilonidal disease to two groups of surgeons, each group being     trained for one of the two methods.   "
196035|NCT00412672|"     The hypothesis of the current proposal is that collateral flow is an important determinant of     myocardial protection during an ischemic event. Increased collateral flow for any given area     at risk will decrease the myocardial damage caused by the occlusion of the infarct related     epicardial artery.      It is further hypothesized that myocardial salvage provided by collateral flow will decrease     infarct size and this in turn will decrease LV dilatation post-myocardial infarction.   "
196036|NCT00412685|"     Patients with congenital heart disease in whom the right ventricle is exposed to pressure or     volume overload show progressive systolic dysfunction of the right ventricle, the fact of     which conveys substantial morbidity and mortality. The aim of this study is to investigate     the myocardial perfusion in these patients by myocardial contrast echocardiography (MCE) in     order to determine whether disturbed blood flow plays a role in the development of right     ventricular systolic dysfunction.   "
196037|NCT00412698|"     Primary :      To determine the effect of Rimonabant 20 mg on changes in, HDL-Cholesterol (HDL-C),     triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet     in abdominally obese patients with dyslipidemia with or without other associated     comorbidities.      Main Secondary :      To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist     circumference (WC), body weight, glycemic and lipid parameters.      To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.      In selected sites, a sub study will be conducted to determine the effect of 12 months of     Rimonabant on additional lipoprotein and inflammatory parameters.   "
196038|NCT00412724|"     The Food Acceptability Questionnaire (FAQ) is a self-report measure of palatability, ease of     preparation, satisfaction, and perceived benefits and adverse effects related to a prescribed     or self-selected diet. This study intends to develop a reliable and valid food acceptability     questionnaire for use in clinical studies in which dietary interventions are administered.   "
196039|NCT00412737|"     This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal     prophylaxis of influenza in immunocompromised participants (as represented by transplant     recipients). Transplant recipients enrolled when influenza is circulating in the community     will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily     (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will     be recorded throughout the study.   "
196041|NCT00412763|"     The overall objective of this project is to assess whether Silymarin therapy shortens illness     or prevents complications in patients with acute hepatitis. We will specifically compare     responses in acute hepatitis patients treated with Silymarin to those given a control     preparation of a vitamin supplements in a double blinded, randomized, placebo-controlled     trial.   "
196042|NCT00412776|"     The purpose of this study is to compare the safety and efficacy of Proxinium plus best     supportive care with best supportive care only for patients with squamous cell head and neck     cancer.   "
196043|NCT00412789|"     The study will evaluate the safety and efficacy of Patupilone in adult patients with advanced     solid tumors.   "
196044|NCT00412802|"     The objective of the VALIDE study is to validate that a 25% dose reduction of enoxaparine in     patients with moderate renal failure (creatinine clearance between 30 and 50 ml/min) and     hospitalized for an acute coronary syndrome provides at steady state a similar anti Xa level     in plasma compared to that obtained in patients without renal failure and receiving the usual     dose of 1 mg/kg subcutaneously every 12 hours. 140 per - protocol patients are planned to be     included.   "
196045|NCT00412815|"     The purpose of this study was to determine the effects of exercise training on insulin     resistance in subjects with coronary artery disease independent of changes in weight, diet,     or the effect of an acute bout of exercise. We hypothesized that subjects with CAD and high     normal or impaired glucose tolerance performing 12 weeks of aerobic exercise training while     on a non weight-reducing diet, would have a greater decrease in insulin resistance than     controls measured at 72 hours following their last bout of exercise.   "
196046|NCT00412828|"     This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in     patients who have unresectable stage III or stage IV melanoma and have failed no more than 1     line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once     every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the     MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy     of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be     explored.   "
196088|NCT00413387|"     The aim of this study was to compare the efficacy and tolerability of the fixed combination     beclomethasone/formoterol pMDI with that of budesonide/formoterol dry powder via Turbuhaler.   "
196049|NCT00412867|"     The purpose of this study is to confirm the efficacy and safety of intravenously administered     alteplase in patients with acute ischemic stroke based on the rate of recanalization assessed     by magnetic resonance angiography (MRA), the rate of patients with a modified Rankin Scale     (mRS) score of 0-1, and the incidence of symptomatic intracranial hemorrhage (sICH), in     comparison with the data reported in the current literature.   "
196050|NCT00412880|"     Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in     second line treatment in sensitive-relapse SCLC patients.   "
196051|NCT00412893|"     The purpose of this study is to compare the efficacy and safety of isavuconazole versus     voriconazole in the treatment of patients with invasive aspergillosis.   "
196052|NCT00412906|"     The aim of the present protocol is to study gene activity in fat and muscle tissue in type 2     diabetics and healthy volunteers after injection of E. coli endotoxin.We hereby hope to gain     insight in some mechanisms behind the association between inflammation and insulin     resistance.   "
196053|NCT00412919|"     This is a Phase II trial evaluating the overall response rate, safety and tolerability to     azacitidine in patients with relapsed or refractory multiple myeloma.   "
196054|NCT00412932|"     This 14 week study will examine the ability of olmesartan medoxomil to lower the blood     pressure of patients 65 years of age or older with high blood pressure. The medication being     tested has been approved by the FDA for the treatment of high blood pressure.   "
196055|NCT00412958|"     A multicenter study to compare multiple doses of intravitreal microplasmin in patients     undergoing surgical vitrectomy.   "
196056|NCT00412971|"     The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted     Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with     suspicion of non-invasive bladder cancer.      The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix     assisted TURB compared to standard white light TURB.   "
196057|NCT00412984|"     The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is     as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in     subjects with atrial fibrillation and risk factors for stroke.   "
196058|NCT00412997|"     The phase I study will evaluate the safety, efficacy and pharmacokinetics of LBH589B in adult     patients with advanced solid tumors or Cutaneous T-cell lymphoma   "
196059|NCT00413010|"     The primary objective of this study is to evaluate the efficacy of pregabalin as compared to     placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be     measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from     baseline observed following 8 weeks of double-blind treatment or at earlier termination     during the double-blind treatment phase and analyzed using a mixed linear model for repeated     measures.   "
196060|NCT00413023|"     The purpose of this study is to assess the efficacy, safety and tolerability of GW679769     patients with Major depressive Disorder (MDD).   "
196061|NCT00413036|"     Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle.     Treatment will continue until disease progression, or unacceptable adverse events develop   "
196062|NCT00413049|"     This study will evaluate the safety and efficacy of the fixed combination of     valsartan/amlodipine in adult patients with mild to moderate hypertension   "
196063|NCT00413062|"     The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding     patterns (cycle control), general safety and acceptability of the nomegestrol     acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged     18-50 years.   "
196064|NCT00413075|"     This is a Phase I dose escalation study of PXD101 administered orally. Oral belinostat will     be given once or twice daily at various dosing schedules to patients with solid tumors. Doses     will be escalated until the maximum tolerated dose (MTD) is identified. In parallel, a cohort     of lymphoma patients will be given oral belinostat on a discontinuous once daily dosing     schedule.   "
196065|NCT00413088|"     Open pharmacokinetic study with 5 parallel groups and two treatment phases (bemiparin 3,500     IU multiple dose and bemiparin 115 IU/kg single dose). The bemiparin pharmacokinetic profile     will be assessed by measuring its effects on the coagulation cascade. Plasma anti-Xa activity     (measured using chromogenic amidolytic assay) in IU per milliliter will be the primary     endpoint to assess the pharmacokinetic profile of bemiparin.   "
196066|NCT00413101|"     This single arm study will determine the effects of complete anemia correction in anemic     patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon.     Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be     treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to     reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart     function and quality of life will be measured before and after anemia correction. The     anticipated time on study treatment is 3-12 months, and the target sample size is 100     individuals.   "
196067|NCT00413114|"     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow     unchecked when an oncogeneic signal is present. Obatoclax is designed to restore apoptosis     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process     of cell death that is often inhibited in cancer cells.      This is a multi-center, open-label, Phase II study of obatoclax administered in 2-week cycles     to patients with previously-untreated Myelodysplastic Syndromes with anemia and/or     thrombocytopenia. Treatment may be administered on an outpatient basis. No investigational or     commercial agents or therapies other than those described herein may be administered with the     intent to treat the patient's malignancy. Supportive care measures including those directed     at controlling symptoms resulting from Myelodysplastic Syndromes are allowed   "
196068|NCT00413127|"     The purpose of this study is to comparing effects of intravenously (IV) administered     lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing     elective colorectal surgery   "
196089|NCT00413400|"     This study will investigate whether etanercept will result in improved inflammatory indices,     glucose tolerance and endothelial function in patients with the metabolic syndrome.   "
196090|NCT00413413|"     This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine     in adult patients with mild to moderate hypertension.   "
196069|NCT00413140|"     Background Chronic airway inflammation is present in cystic fibrosis. Non-invasive     inflammometry may be useful in disease management.      Objective We studied 1) the ability of fractional exhaled nitric oxide and inflammatory     markers (acidity, nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor     necrosis factor-α, interleukin-2,-4,-5,-10) in exhaled breath condensate, to discriminate     between cystic fibrosis and control children, and, 2) the relationship of biomarkers with     control and severity of cystic fibrosis.      Methods In 98 children (48 cystic fibrosis / 50 controls), condensate was collected using a     glass condenser. Exhaled nitric oxide was measured using the NIOX®.   "
196070|NCT00413153|"     To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat     in HIV-infected patients.   "
196071|NCT00413166|"     The goal of this clinical research study is to learn if the combination of arsenic trioxide     (ATO) with ATRA and possibly idarubicin is effective in treating patients with     newly-diagnosed APL.   "
196072|NCT00413179|"     The purpose of our study was to conduct a placebo controlled, double-blind randomized trial     in chronic oligoovulatory or anovulatory , hyperandrogenic, infertility patients comparing     the effects of adjuvant metformin plus clomiphene citrate to clomiphene citrate plus placebo     on pregnancy rates and ovulation rates. We hypothesized that combining metformin with     clomiphene citrate would result in higher ovulation and pregnancy rates in hyperandrogenic     women who have chronic oligoovulation or anovulation as the sole etiology for their     infertility and who have unknown responsiveness to clomiphene citrate.   "
196073|NCT00413192|"     The purpose of this study is to evaluate the therapeutic activity and safety of E7389 in     patients with advanced/metastatic soft tissue sarcoma who have failed standard chemotherapy.   "
196074|NCT00413205|"     This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus     placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy.     Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive     either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition     to their standard therapy. Following the double-blind treatment period, patients will enter a     4-week follow-up period. The anticipated time on study period is 1-2 years, and the target     sample size is 100-500 individuals.   "
196075|NCT00413218|"     The purpose of the study is to compare the safety and efficacy of isavuconazole versus     caspofungin followed by voriconazole in the treatment of candidemia and other invasive     Candida infections.   "
196076|NCT00413231|"     This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft     to treat thoracic aortic aneurysms.   "
196077|NCT00413244|"     The purpose of the study is to find out if giving the study drug, Androgel (testosterone) as     a testosterone replacement help bring the testosterone to an acceptable level and to find out     if it will help improve heart condition in males with coronary artery disease (CAD) following     successful percutaneous coronary intervention.   "
196078|NCT00413257|"     Postoperative pain after major surgery is consecutive not only to the nociceptive inputs     coming from the surgical lesion, but also to peripheral and central neuronal sensitization.     This lead to postoperative hyperalgesia and allodynia that are enhanced by the per operative     use of high opioid doses. Anti-NMDA drugs have been reported as able to reduce this     sensitization process and then to decrease acute morphine tolerance during the postoperative     period. Nefopam has been lately shown to combine in experimental trials analgesic and anti     hyperalgesic effects. The aim of this study is to compare anti-hyperalgesic effects of     nefopam given either before incision and continuously for the following 48hours or starting     from the end of the surgery and given for 48hours to a control group that would receive     placebo for 48hours. Postoperative analgesia will be based on morphine PCA. Pain scores,     hyperalgesia, allodynia, postoperative morphine consumption, and development of chronic pain     will be the main criteria that will be evaluated during this study   "
196079|NCT00413270|"     This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or     -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with     nilotinib. Patients will be provided access to nilotinib until the drug is available on the     market.   "
196080|NCT00413283|"     The purpose of this study is to identify an effective, well tolerated dose and schedule of     romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia     (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.   "
196081|NCT00413296|"     The purpose of this study is to evaluate the short-term efficacy and safety of levetiracetam     in post-traumatic stress disorder (PTSD) and to evaluate continuation effects of     levetiracetam in preventing PTSD relapse. The hypothesis is that levetiracetam will be safe     and effective in preventing relapse of PTSD.   "
196082|NCT00413309|"     To determine the rate of symptomatic and asymptomatic gastrointestinal erosions and     ulcerations in patients on dual antiplatelet (aspirin and clopidogrel) therapy after     percutaneous coronary intervention (PCI).   "
196083|NCT00413322|"     This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with     advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor     activity, and how the study drug behaves within the body when given with 5-Fluorouracil     (5-FU).   "
196084|NCT00413335|"     The purpose of the study is to determine whether treatment of children and adolescents with     Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin     sensitivity and glucose tolerance.   "
196085|NCT00413348|"     Insulin-resistance in type 2 diabetes is associated with chronic inflammation.     Anti-inflammatory actions might increase sensitivity to insulin. Since some probiotics have     anti-inflammatory properties, ingestion of the probiotic bacteria Lactobacillus Acidophilus     NCFM might increase insulin-sensitivity.      The inflammatory response to endotoxin injection and the insulin-sensitivity is examined     before and after four weeks ingestion of probiotics.   "
196086|NCT00413361|"     The main objective of study PLUS is to determine the potential benefits of individualized HCQ     dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/ml   "
196087|NCT00413374|"     To investigate the efficacy and safety of once daily enoxaparin as a bridge to warfarin for     the outpatient treatment of acute deep venous thrombosis or pulmonary embolism.   "
196098|NCT00413517|"     The purpose of this study is to evaluate the safety and efficacy of Epi-Lasik in U.S. Army     personnel who have naturally occurring myopia with or without astigmatism. The data from this     control group will be collected in such a way as to be comparable to data sets from study     groups undergoing wavefront guided PRK, conventional PRK, and related laser refractive     surgery procedures.   "
196099|NCT00413543|"     This is a study to evaluate the effects of early pulmonary rehabilitation within 10 days     after discharge from the hospital after a COPD exacerbation on exercise tolerance,     exacerbations, re-admissions and the quality of life during 6 months.   "
196100|NCT00413556|"     We plan to determine changes in the immune system during the allergic response to grass     pollen allergens. We have chosen a particular element of the immune response, the     immunoglobulin G4 (IgG4) as an indicator.      We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense     specific IgG4 and IgE, as well as reduce the cutaneous sensitivity of the early (IgE     mediated) and late (cell mediated) allergic response.   "
196101|NCT00413569|"     The specific aim of this study is to demonstrate that inserting a breathing tube using a     standard laryngoscope with the patient fully anesthetized is a safe and effective means of     securing the airway in a patient with cervical spine disk herniation or stenosis. The two     groups compared are composed of those who are intubated with direct laryngoscopy and those     who are intubated with a fiberoptic scope.   "
196102|NCT00413582|"     The objective of this study is to scientifically evaluate two different management strategies     for post-operative pain after pectus excavatum repair.      The hypothesis is that pain management without an epidural decreases hospital stay without     compromising comfort.      The primary outcome variable is length of hospitalization after the intervention.   "
196103|NCT00413595|"     New studies indicate that in about 1 - 2 percent of the younger stroke patients the cause     could have been an undiagnosed genetic disease, the so called Fabry disease. In this case     certain fat molecules are not digested and broken down by the body - but remain in the cells.     These fat molecules build up to dangerous levels, which start to damage the body, because     they accumulate e.g. in the walls of the blood vessels. This accumulation in the blood     vessels of the whole body may cause life-threatening malfunctions in the brain, inducing a     stroke.      The purpose of this study is to investigate the stroke rehabilitation of Fabry patients     during different therapeutic standard approaches for stroke and for Fabry disease (if any).     During this study, stroke patients with Fabry disease will be monitored in greater detail to     determine whether the differences in treatment are significant for patient recovery and on     what they depend.   "
196104|NCT00413608|"     To test pharmacodynamic response to clopidogrel 150mg once daily during 7 days in healthy     subjects carriers of a mutated allele (*2) associated with CYP2C19 deficiency and non     responders to the usual regimen of 75 mg once daily   "
196135|NCT00414024|"     This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation     in patients with non-cancer pain.      Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive     the treatment as follows:      Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod     12 mg o.d. using an allocation ratio of 1:1.      Patients who enter this study AFTER the core study interim analysis receive the treatment as     follows:      Patients will be assigned to receive the selected tegaserod dose regimen (as determined by     the core study interim analysis) in an open label fashion.   "
196136|NCT00414037|"     If you are age 20-55 years old and have trouble falling or staying asleep, then please     contact a UCSD research team to find out how a study drug affects these symptoms and how your     brain works. This is a one-week experimental pain research study using a study drug compared     to placebo. Your participation will include questionnaires, a physical exam and functional     Magnetic Resonance Imaging (fMRI) brain imaging techniques. We will test pain perception by     applying brief mild to moderate heat pain to the forearm, and also have you perform simple     computer tasks while we image and record brain activity using fMRI.   "
196105|NCT00413621|"     The study will investigate the possibility of detecting early signs of Alzheimer's disease     using magnetic resonance imaging (MRI). If plaques, types of damage, can be imaged by MRI,     the procedure could be used in clinical trials and may also help in the clinical diagnosis of     patients. Alzheimer's disease, a progressive disease, is a major cause of functional     disability and institutionalization, affecting 4.5 million people in the United States, a     number that will more than triple by 2030 as the population ages.      Patients ages 55 to 90 who have mild symptoms of Alzheimer's disease and who are in good     health may be eligible for this study. Twenty patients will be recruited from Johns Hopkins'     Alzheimer's Disease Research Center. There will also be a control group of 20 people without     the disease.      Healthy patients and volunteers will have a clinical MRI brain scan and a neurological     examination at Johns Hopkins Hospital before the 7T MRI scan. Also, patients will have a     Mini-Mental State Examination, a standardized test to evaluate memory, done at Johns Hopkins     within 4 weeks of the 7T MRI. This study uses a device situated at the NIH Bethesda campus     that operates at a high magnetic field strength of 7 Tesla, that is, the unit used to measure     the strength of a strong magnet. The Food and Drug Administration has categorized MRI up to 8     Tesla as not a significant health risk. MRI scanning is routinely done at magnetic field     strengths up to 4T. MRI images are created through the use of a large magnet and radio waves.     During the procedure, patients lie on a table moved into a strong magnetic field. They are     asked to lie still but can easily hear and speak to research staff. A respiratory belt is     placed around the chest, and a finger probe is placed on the finger, to monitor breathing and     heart rate. For obtaining a better picture, a special lightweight coil may be placed on or     around the patient's head. The scan takes from 20 minutes to 2 hours, with most scans at 45     to 90 minutes. Due to limited experience with the use of 7T MRI and its investigational     nature, patients will be asked to complete a questionnaire immediately after the study. They     will be asked about their comfort level and if they experienced unusual sensations. Answers     will be reviewed with patients by an experienced MRI investigator to get details of any     unusual sensations reported. If patients experience unusual sensations, they are followed up     by phone within 24 hours.      This study wi...   "
196106|NCT00413634|"     Age related differences in response to a drug could arise from variation in pharmacokinetic     (PK) and/or pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety     profile of anagrelide is well established through a well-documented clinical trial programme     in patients of all ages, no formal studies have been carried out to investigate whether the     PK profile of anagrelide and its metabolites is altered with age.      This study is designed to allow comparisons to be made in terms of pharmacokinetics of     anagrelide and its metabolites between elderly (≥ 65 years) and young (18-50 years) ET     patients   "
196107|NCT00413647|"     Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD     subjects both male and female between the ages of 50-85. Nine normal controls will undergo     repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal     healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging     only.   "
196108|NCT00413660|"     The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6     dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with     active rheumatoid arthritis.   "
196109|NCT00413673|"     The objective of this study is to conduct a prospective clinical trial to evaluate the safety     and efficacy fo the VISX Excimer Laser system for the treatment of naturally occurring low to     moderate myopia, with or without low levels of astigmatism, in U.S. Army personnel.   "
196110|NCT00413686|"     This is an open-label, multi-center, dose-escalation, Phase I study to evaluate the safety,     tolerability, and pharmacokinetics and to investigate biomarker changes of AZD7762     administered as a single intravenous unit and in combination with gemcitabine. The study is     sponsored by AstraZeneca.   "
196111|NCT00413699|"     The purpose of this study is to determine the long-term effectiveness and safety of     CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study     only after participating in another qualifying study of CP-690,550      A sub-study will be conducted within the A3921024 study, this study will evaluate the immune     response to pneumococcal and influenza vaccines in patients receiving CP-690,550   "
196114|NCT00413738|"     The aim of this prospective randomised controlled trial is to compare the incidence of     catheter-related bloodstream infection in 2 groups of patients with hemato-oncological     disease:      Group A: heparin-coated central venous catheters (Control Group) Group B: antiseptic-coated     (chlorhexidine-silver sulfadiazine) central venous catheters   "
196115|NCT00413751|"     The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic     solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.   "
196116|NCT00413764|"     Tibolone has been registered for treatment of menopausal symptoms. It is, however, not known     what the effects are of tibolone in postmenopausal women diagnosed with sexual dysfunction.     This is important because there is currently no approved treatment of libido problems in     postmenopausal women. Therefore, the primary aim of this study was to compare the effects of     tibolone with an estrogen/progestogen skin patch in postmenopausal women diagnosed sexual     dysfunction.   "
196117|NCT00413777|"     This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to     determine the maximally-tolerated dose and acquire pilot efficacy data in patients with     autosomal dominant polycystic kidney disease (ADPKD).   "
196118|NCT00413790|"     This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine     on cardiovascular parameters in healthy subjects 50 years of age and older   "
196119|NCT00413803|"     The investigators hypothesize that an increase in the duration of dialysis session in thrice     weekly center hemodialysis may provide better outcome, less morbidity, higher quality of     life, lesser requirement of medications, and lower total cost.   "
196120|NCT00413816|"     The purpose of the study is to determine the trigger for blood transfusions in Israeli ICU     patients and the possible effects of anemia on the post ICU discharge course.   "
196121|NCT00413829|"     This study is an evaluation of the short term effects on CNV perfusion of a same-day     administration of photodynamic therapy (PDT) with Visudyne® and an intravitreal injection of     Lucentis® (ranibizumab, 0.3 mg). An evaluation of the short term effects on CNV perfusion of     this combined treatment is needed for better understanding of treatment effects.   "
196137|NCT00414050|"     This study was conducted in healthy infants and will provide new immunogenicity and safety     data for the modified process hepatitis B vaccine. This study was conducted to address the     following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the     modified process hepatitis B vaccine compared with a 10 microgram dose of the modified     process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and     to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).   "
198173|NCT00441246|"     The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in     providing symptom relief when administered as an adjunct to antibiotic therapy in patients     with acute respiratory infection.   "
196122|NCT00413842|"     This study will evaluate whether applying electrical stimulation on the cerebellum (posterior     and lower part of the brain) can influence brain excitability and hand movement performance.      A new technique became available to stimulate the brain: transcranial direct current     stimulation (tDCS), which could improve the ability to learn. Researchers do not know whether     applying tDCS over the cerebellum could also influence motor function, and they want to     examine changes in brain excitability, by using transcranial magnetic stimulation (TMS).      Patients ages 18 to 40 who are not pregnant may be eligible for this study. They will come to     NIH for a medical history and completing a questionnaire about memory and attention. There     will be five experiments, each up to 5 hours, for about 1 to 5 weeks, in which patients     perform tasks like pinching a special device between the thumb and index fingers, or reaching     for target objects on the computer screen. Patients will receive mild electrical stimulation     over a different part of the head each day. Some experiments are done without the electrical     current, but patients will not know which ones are with or without stimulation. There are     also short questionnaires about attention, fatigue, and mood, to be completed before, during,     and after each experiment.      Patients will be connected to an electromyography (EMG) machine, to measure electrical     activity of muscles. Electrodes are taped to the skin over one small hand muscle. TMS allows     electrical pulses to pass through the brain to stimulate it. TMS is used at the beginning of     each experiment to determine the precise location on the scalp of two target areas:     cerebellum and motor cortex. TMS is a safe procedure. Discomfort, headache, or nausea can     occur, but all symptoms usually go away promptly. During motor learning under tDCS, also a     safe procedure, patients sit in a comfortable chair, and the arm and wrist and arm are kept     still. Sponge electrodes are applied on the chin, back of the head, neck, collarbone, lateral     part of the head, or above the eyebrow. A small electrical current is passed between     electrodes. Patients may feel an itching or tingling sensation under the electrodes or see     slight light flashes. tDCS is applied for 20 to 30 minutes. A magnetic resonance imaging     (MRI) scan, which may also be involved, uses a strong magnetic field and radio waves to     obtain images of body organs and tissues. Patients lie on a table in a cylinder and may be     asked to lie still for up to 60 minutes at a time.      This study will not have a direct benefit for participants. However, knowledge gained may     help researchers identify ways to improve movement in people with a brain injury, such as     chronic stroke.   "
196123|NCT00413855|"     It is questionable whether elective appendectomy can effectively reduce pain in persistent or     recurrent lower abdominal quadrant pain due to chronic appendicitis.      A single centre randomised double-blind sham surgery controlled clinical trial studied the     effects of elective laparoscopic appendectomy on postoperative pain perception in patients     with persistent or recurrent lower abdominal quadrant pain on abdominal pain at 6 months     postoperatively. Secondary outcome was the relation between clinical response and the     appendix’ histopathology. The analysis was performed on an intention-to-treat basis. Pain     scores were compared using a Fisher’s exact test.   "
196124|NCT00413868|"     The purpose of this study is to conduct a prospective assessment of small target contrast     sensitivity and disability glare in refractive surgery. Study subjects will undergo the     treatment of their choice (PRK or LASIK) and will be evaluated before and after treatment.     Evaluations will include best corrected visual acuity, uncorrected visual acuity,     psychometric questionnaire, pupil size, biomicroscopic examination, manifest refraction,     wavefront measurements, low contrast acuity, and contrast sensitivity at normal and at low     luminance with and without disability glare.   "
196125|NCT00413881|"     The purpose of this study is to conduct a prospective clinical trial to compare conventional     and WFG LASIK for enhancements on post-LASIK patients. Differences in safety, efficacy,     visual quality, and refractive stability will also be compared during this study.   "
196126|NCT00413894|"     This single arm study will assess the efficacy and safety of intravenous Mircera,     administered with pre-filled syringes, for the treatment of anemia in patients with chronic     kidney disease who are on dialysis, and who have previously received treatment with epoetin     alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of     Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin     they were receiving in the week preceding study start. The anticipated time on study     treatment is 3-12 months, and the target sample size is 500+ individuals.   "
196127|NCT00413920|"     This study will investigate the efficacy and safety of a steroid avoidance regimen in     comparison with steroid treatment in combination with an initially higher dose of     enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal     transplant recipients. Patients will be randomly allocated to receive either EC-MPS or     steroids in combination with EC-MPS. Patients of both treatment groups will receive     monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.   "
196128|NCT00413933|"     The purpose of this study is to determine whether the comprehensive multidisciplinary     intervention (geriatrician, physical therapist and occupational therapist falls risk     assessment and intervention)is effective in the falls prevention in the community dwelling     elderly.   "
196129|NCT00413946|"     The main goal of this trial is to investigate whether early administration of human     erythropoietin (EPO) in very preterm infants improves neurodevelopmental outcome at 24 months     corrected age.      This study is designed as randomized, double-masked, placebo controlled multicenter study     involving at least 420 patients.   "
196130|NCT00413959|"     Overall response rate and Time to disease progression using this regimen in patients with     low-grade B-Cell Non-Hodgkin's Lymphoma.   "
196131|NCT00413972|"     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3     study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10     mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg)     compared to placebo administered daily for 8 consecutive weeks in subjects with primary     hypercholesterolemia (LDL-C >3.64 mmol/L [140 mg/dL]). The efficacy of daily Vytorin versus     placebo in reducing the concentration of LDL-C will be evaluated, and the efficacy of daily     Vytorin versus placebo with respect to change in the concentrations of total cholesterol,     triglycerides, and HDL-C will be compared. The safety of Vytorin versus placebo will also be     assessed.   "
196132|NCT00413985|"     The purpose of this study is to determine whether low birth weight (LBW) infants fed human     milk (HM)supplemented with a specially designed powdered human milk fortifier until 12 weeks     after hospital discharge will have better growth and neurodevelopment than infants fed HM     alone.   "
196133|NCT00413998|"     The study is a randomised controlled trial comparing two treatment strategies for patients     with moderate functional ischaemic mitral regurgitation undergoing coronary artery bypass     grafting (CABG). Patients will be randomised to receive either CABG alone or CABG plus mitral     annuloplasty. The objective of the study is to determine if mitral annuloplasty in addition     to CABG improves outcome in patients with moderate functional ischaemic mitral regurgitation.   "
196134|NCT00414011|"     The purpose of this study is a prospective,double-blinded, randomized trial to compare the     rate of healing following PRK after the use of two commercially available 4th generation     fluoroquinolones, moxifloxacin and gatifloxacin.   "
196138|NCT00414063|"     This study will examine whether there are differences in energy (calories) losses in stool     and urine between lean and obese people. People gain weight when the amount of calories in     the food they eat is greater than the amount of calories their body uses to support its     functions and activities. The balance between caloric intake and expenditure may be affected     by the amount of calories from food that is not absorbed but is lost in stool and urine. This     study will examine whether differences in food absorption are related to obesity.      Healthy normal volunteers between 18 and 45 years of age with a body mass index (BMI) of     18-25 kg/m2 or less than 35 kg/m2 may be eligible for this 15-day study. Participants are     admitted to the Clinical Research Unit at the Phoenix Indian Medical Center for the study.      Participants undergo the following tests and procedures:        -  Experimental diets with dye marker: Subjects are fed a 2400-calorie diet and a          3400-calorie diet for 3 days each. On the first of the day of each diet, a blue dye          marker is added to the breakfast meal. A red marker is added to the breakfast meal of          the first day after the diet period. Urine is collected beginning after breakfast on the          first day of the diet and until before breakfast on the last day of the diet. Stool          samples are collected during the entire diet period, and until the appearance of the red          dye in the stool.        -  24-hour metabolic rate in the respiratory chamber: After the first diet period, subjects          spend 24 hours in a respiratory chamber to measure the number of calories the body burns          a day and to assess the energy balance between intake and expenditure.        -  Stool sample: Stool samples are collected on days 1 and 2 of the study to look for          parasites or internal bleeding that may affect nutrient absorption.        -  DXA scanning: This scan uses a low dose of X-rays to measure body fat.        -  Oral glucose tolerance test: For this test for diabetes, an I.V. line (needle attached          to a small plastic tube) is inserted into an arm vein. The subject drinks a sugar          solution. Small blood samples are drawn from the I.V. before the subject drinks the          solution and at five intervals during the 3 (Omega)-hour test period.        -  Fasting blood tests: On the first day of each diet and on the day after each diet is          completed a blood sample is drawn before breakfast to measure hormones that may affect          the ability to absorb food.      At the end of the study, some participants may be asked to repeat the experimental diets and     stool and urine collections.   "
196139|NCT00414076|"     The goal of this clinical research study is learn if taking Femara (letrozole) after a     hysterectomy (surgical removal of the uterus) for uterine leiomyosarcoma will delay or     prevent the cancer from coming back.   "
196140|NCT00414089|"     The purpose of this study is to see how well Zevalin works in the treatment of low grade     indolent B-cell lymphoma when given to patients who have not had any previous treatment for     their lymphoma and who otherwise would be followed on a watch & wait policy.   "
196141|NCT00414102|"     The purpose of this study is to determine the subjective treatment effects of ramelteon, once     daily (QD), on sleep using a post sleep questionnaire-interactive voice response system in     adults with chronic insomnia.   "
196176|NCT00414557|"     To investigate the effects of quadriceps strengthening on the adductor moment in individuals     with medial knee OA and whether quadriceps strengthening has a different effect on the     adductor moment in individuals with and without knee malalignment   "
196190|NCT00414752|"     The purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine     compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in     healthy smokers. This study will also assess how the body interacts with AFQ056.   "
196191|NCT00414765|"     This study will evaluate the pharmacokinetics of aldesleukin in patients with metastatic     renal cell cancer and metastatic melanoma   "
196142|NCT00414115|"     The purpose of the study is (1) to identify and collect samples from children and adults who     take drugs and have adverse drug reactions AND children and adults who take drugs and do not     experience any adverse drug effects; (2) to determine if genetic differences between the two     groups contribute to causing the adverse drug reactions; and (3) to develop patient specific     drug dosing guidelines to prevent future adverse drug reactions. We also wish to compare the     use of prescription drugs, medical and hospital services and vital statistics between BC     participants who experience adverse drug reactions and those who do not.      Study hypothesis: Genetic differences may contribute to patients' response to drugs and may     be responsible for adverse drug reactions.   "
196143|NCT00414128|"     The purpose of this study is to investigate whether mycophenolate mofetil is effective as     treatment for new cases of ANCA associated vasculitis.   "
196144|NCT00414141|"     Grass MATA MPL has been developed by Allergy Therapeutics (UK) Ltd. to provide pre-seasonal     specific immunotherapy for patients with proven type I hypersensitivity to cross reacting     grass pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma     bronchiale. The purpose of this study is to compare the efficacy of Grass MATA MPL versus     placebo in grass-allergic subjects following 4 subcutaneous injections of study medication     administered before the start of the 2007 grass pollen season.   "
196145|NCT00414154|"     Modification of individual life style factors and fall prevention programmes may have     significant positive effects on fracture incidence. Also, a large number of studies have     demonstrated that pharmacological therapy of osteoporosis is effective; however non-adherence     to such therapy is a well recognized problem. Few studies, however, have examined the effect     of particular patient education programmes on knowledge and adherence to therapy.      We hypothesised that a group-based, multi-disciplinary, education programme increases the     total quality of treatment for patients with osteoporosis, Patients' knowledge on     osteoporosis and adherence with pharmacological therapy ect.      A total of 300 patients, recently diagnosed with osteoporosis and started on specific     treatment, were randomised to either the school or control group. In the school-group,     patients attended four classes with 8-12 participants during four weeks (a total of 12     hours). Teaching was performed by nurses, physiotherapists, dieticians, and doctors and was     based on dialogs and situated learning. The classes covered facts on osteoporosis,     fractures and pain, diet, preventive measures, balance and exercise, and medical     treatment. Teaching was designed to increase empowerment. The control group were offered the     department's standard treatment including follow-up visits.      All 300 patients received questionnaires regarding Knowledge about Osteoporosis, Level of     Adherence, Quality of life, Dietary calcium intake, Level of physical activity, Falls     events registered every month by postcard, at inclusion and after 3, 12, and 24 month. BMD     was examined by DXA-scan at inclusion and after 12 and 24 month. The last patient will answer     the questionnaires first of May 2007.   "
196146|NCT00414167|"     This research study is designed to look at the effectiveness of bupropion for reducing binge     eating in overweight persons with binge eating problems. Participants in the study will     receive either bupropion or placebo (sugar pill, inactive medication) as an outpatient for     eight weeks. In addition, participants will be given the option to receive 8 weeks of free     behavioral weight loss treatment. This treatment, known to be effective for reducing binge     eating and helping people lose weight, will be administered following the medication phase     and at no cost.      It is expected that compared to placebo, bupropion will produce greater reductions in binge     eating.   "
196147|NCT00414180|"     To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless     tobacco users.   "
196149|NCT00414206|"     This is a Phase II randomized, double-masked study comparing the safety and efficacy of     ATG003 (mecamylamine HCl) 1.0% and 0.3% ophthalmic solutions to placebo in patients with     neovascular (wet) age-related macular degeneration (NV-AMD).   "
196150|NCT00414219|"     The purpose of this study is to assess visual quality of patients with non-penetrating,     non-metallic, stable corneal foreign bodies. Visual quality will be assessed by examining     visual acuity, wavefront analysis and contrast sensitivity. Drawings, photographs, and     confocal microscopy will be used to document clinical examination of the cornea at baseline     and on follow-up examinations.   "
196151|NCT00414232|"     Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving     Chemo-Radiotherapy.   "
196152|NCT00414245|"     The purpose of this study is to determine whether metformin is effective and safe in the     treatment of diabetes in pregnancy.   "
196153|NCT00414258|"     The purpose of this study is to compare the effects of mothers' skin-to-skin holding during     feeding via a soother trainer with the effects of pacifier sucking on preterm infant     biobehavioural responses during and immediately after a painful procedure      Hypothesis:        1. When held by their mothers during blood collection, preterm infants will show less pain          reaction than when sucking on a pacifier.        2. Following holding during the blood collection, mothers will find no differences in their          infants' feeding ability.   "
196154|NCT00414271|"     Thymidylate Synthase (TS) is a key enzyme in the synthesis of DNA and the target enzyme     inhibited by 5-fluorouracil. TS level in the tumour cells has been reported as predictive to     response to 5-FU and a prognostic factor in colorectal and gastric cancer patients. We plan     to study TS by IHC in the paraffin blocks of tumour tissue.      A combined comparative genomic hybridization (CGH) and expression microarray analysis of     gastric cancer specimens before and after neoadjuvant chemotherapy. CGH will be performed     using standard technique routinely done in Dr Patrick Tan's laboratory at the National Cancer     Centre, which determines the gain or loss of DNA copies of each chromosome. Total RNA will be     extracted from at least one biopsy sample which contains at least 50% cancer cells by     homogenization of the tumour tissue and tri-sol method. 5 ug of RNA were amplized and     hybridized with the C-DNA microarrays of 18K targets.      Primary Objective      1. Feasibility and safety of pre-operative chemotherapy in locally advanced gastric cancer.      Secondary Objective        1. Complete clinical and pathological response rates to pre-operative chemotherapy in          locally advanced gastric cancer        2. Complete resection rate.        3. Time to recurrence, disease free and overall survival        4. Correlation of clinical outcome with RUNX-3 methylation status and Thymidylate          synthetase in the tumor tissue.        5. Correlation of CGH and gene expression profile and their changes after chemotherapy with          clinical outcome.           Patients may be included in the study only if they meet all of the following criteria:           Age at least 18 years. Histologic or cytologic diagnosis of adenocarcinoma of stomach or          gastric cardia (Siewart Classification Type III) Preoperative Stage T3-4NxM0 by          endoscopic ultrasound, CT of the abdomen/pelvis and laparoscopy. (CT of the chest if it          is a cardia lesion). Absence of malignant cells in peritoneal lavage fluid during          laparoscopic examination.           Patients must not have received any prior chemotherapy or hormonal therapy for the          treatment of gastric cancer.           Karnofsky performance status of 70 or higher. Estimated life expectancy of at least 12          weeks.           Adequate organ function including the following:           - Bone marrow: White blood cells (WBC) at least 3.5 x 109/L Absolute neutrophil          (segmented and bands) count (ANC) at least 1.5 x 109/L Platelets at least 100 x 109/L          Haemoglobin at least 9g/dL           - Hepatic: Bilirubin within upper limit of normal (ULN), ALT or AST not more than 2.5x          ULN Alkaline phosphatase not more than 2.5x ULN.           - Renal: creatinine not more than 1.5x ULN Signed informed consent by patient or legal          representative. Patients with reproductive potential must use an approved contraceptive          method if appropriate (eg, intrauterine device, birth control pills, or barrier device)          during and for three months after the study. Females with childbearing potential must          have a negative serum pregnancy test within 7 days prior to study enrollment.           The study plans to recruit 30 patients in 12-18 months.   "
196155|NCT00414284|"     This study will look to see if increasing the standard dose of Kaletra is tolerated and if it     will lower viral loads to undetectable levels. This study will also look at the     pharmacokinetic data (amount of Kaletra in blood at different times).   "
196156|NCT00414297|"     The purpose of this study in humans with stable coronary artery disease (CAD) treatable by     percutaneous coronary intervention (PCI) is to evaluate the efficacy of External     Counterpulsation (ECP) with regard to the promotion of coronary collateral growth.   "
196157|NCT00414310|"     The goal of this clinical research study is to find out if decitabine, given with or without     valproic acid, can help to control AML or MDS. The safety of both treatments will also be     studied.   "
196158|NCT00414323|"     The purpose of this study is to evaluate how taking duloxetine 60mg every day affects the     transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine     (NE), across cells in blood and cerebrospinal fluid.   "
196159|NCT00414336|"     This study will evaluate the safety of an experimental vaccine can protect people from     malaria and study its effects. Malaria, which affects many people in Mali and other countries     in Africa, is caused by germs spread by mosquito bites. In Mali, the disease is the leading     cause of death. Researchers at the Malaria Research and Training Center at the University of     Bamako are working with NIH to develop an experimental vaccine against the disease. The     vaccine, called AMA1-C1Alhydrogel (or AMA1-C1), contains a small part of the malaria-causing     germ. CPG-7909 is a product to improve the body's reactions to vaccines.      Patients ages 18 to 45 who are in good health, who live in Don gu bougou, Mali, and plan to     stay there for the study duration, and who are not pregnant or breast feeding may be eligible     for this study. There will be 24 participants.      At an initial evaluation of 2 to 3 hours, patients will have a physical examination and     undergo blood and urine tests regarding the blood, kidneys, and liver. During the study,     patients will receive two injections of one of the two experimental malaria vaccines.     Injections of the same vaccine each time, 4 weeks apart, are given in an arm muscle. Patients     will receive either AMA1-C1 or AMA1-C1 with CPG-7909 but will not know which of the vaccines     they receive until the study's end. After each injection, patients will stay in the clinic     for 30 minutes for observation. They will return after 1, 2, 3, 7, and 14 days to be examined     and report how they are feeling. Blood and urine samples will be collected at some visits.     Each clinic visit takes 1 to 2 hours. If for some reason a patient receives only one     injection, he or she will be asked to return to the clinic for routine visits until the     study's end. After the first 2 months, patients will return to the clinic once a month for 30     weeks. In that period, 12 blood samples will be taken. Researchers want to be sure that the     vaccine is not harmful as well as to measure the vaccine's effects.      Risks in this study include pain, swelling, and redness at the injection site; fever; and     gastrointestinal problems. Some people have had a temporary decrease in white blood cells     after receiving the vaccine. There is a small chance of a severe allergic reaction. However,     researchers will closely watch patients immediately after each injection and will give     treatment if a serious reaction occurs.      Participants will receive 75 kilos of rice and 75 kilos of millet (165 lb. of ...   "
196160|NCT00414349|"     The purpose of this study is to evaluate lidocaine as topical treatment for peripheral     neuropathic pain (as stand-alone treatment and in combination with systemic treatment)   "
196161|NCT00414362|"     The information collected will optimize the management of patients with urinary tract     infections with secondary bacteremia, primarily with gram negative bacteria especially     Escherichia coli. The current IDSA guideline endorses the use of fluoroquinolones and     trimethoprim-sulfamethoxazole as the first line agents. However, over use of this empiric     regimen could result in in appropriate treatment of bacteremia.   "
196162|NCT00414375|"     The objective of this study is to scientifically evaluate two different operative strategies     for perforated appendicitis with abscess.      The hypothesis is that the increased difficulty of early operation is balanced by the immense     patient investment with delayed operation.   "
196163|NCT00414388|"     The primary objective of this study is to evaluate the safety of combining Sorafenib and     chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.   "
196164|NCT00414401|"     Although beta-blockers are known to prolong survival for patients with reduced left     ventricular ejection fraction, their use in the community and the VA is suboptimal.   "
196165|NCT00414414|"     The purpose of this study is to determine if 30-day survival will be improved with addition     of prednisone to standard tuberculosis (TB) therapy.   "
196166|NCT00414427|"     The primary purposes of this study are the following:        1. To evaluate whether the presence of inflammatory knee osteoarthritis as determined by          ultrasonography can be used as a clinical predictor of patient response to          intra-articular corticosteroids.        2. To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with          the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical          design.        3. To evaluate whether lower extremity strength is improved with intraarticular          corticosteroid injection.      The investigators hypothesize that patients with signs of inflammation by ultrasonography     such as synovitis and effusion will respond better to intraarticular corticosteroid     injection.   "
196167|NCT00414440|"     This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney     expansion as well as worsening of renal function in patients with ADPKD and whether the     application of 5 mg/day everolimus as monotherapy is safe and well tolerated.   "
196213|NCT00415077|"     The purpose of this study is to assess whether there is a significant difference in visual     outcomes or corneal haze after surface ablation for moderate and high myopia in active duty     service members treated with PRK, Mitomycin-C (MMC) PRK and LASEK.   "
196168|NCT00414453|"     This study will determine whether treatment with an extended-release opioid or topical     lidocaine is effective in relieving distal symmetric lower extremity burning pain associated     with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will     have important implications for understanding this chronic pain syndrome, which is widely     assumed to be caused by central nervous system pathology.   "
196169|NCT00414466|"     The purpose of this study is to determine the safety and minimum effective dose of     intraspinal gabapentin when delivered through an implanted drug infusion system.   "
196170|NCT00414479|"     The purpose of this study is to determine the extend and the nature of anemia in school     children and the correlation between anemia and schistosomiasis infections, malaria     infections and/or malnutrition (iron deficiency).   "
196171|NCT00414492|"     Systemic chemotherapy for metastatic colon cancer is often used in the neoadjuvant setting     for patients undergoing liver resection. This treatment is given either to keep the tumor at     bay or reduce its size before the time of resection. While many metastatic tumors might     appear to respond well and even radiographically disappear following neoadjuvant therapy, it     is unclear whether grossly or radiographically negative areas of previous disease are     microscopically free of tumor cells. As such, when possible, resection boarders typically     follow 1 cm margins from the tumor size prior to neoadjuvant therapy. These margins might be     necessary to encompass all histologically present disease or they might be unnecessarily     large, serving only to increase the mortality and morbidity of the operation. This study     begins to address this question by a histological examination of the pattern of cell death in     areas of metastases removed after neoadjuvant therapy. Furthermore, clinical cases in which     neoadjuvant therapy allowed for resection of previously unresectable cancer will be examined     to determine whether there is an increased rate of recurrence despite negative resection     boundaries in these cases.   "
196172|NCT00414505|"     The purpose of this study is to determine whether intradermal acupuncture is effective and     safe in the treatment of obesity.   "
196173|NCT00414518|"     The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug     regimen followed by treatment interruption in people recently infected with HIV. This study     will also compare the effects of a treatment regimen including treatment interruption with a     treatment plan based on clinical indicators.   "
196174|NCT00414531|"     The primary objective of the study is to investigate the ratios of p-hydroxyatorvastatin to     atorvastatin in patients receiving atorvastatin treatment, who experience muscle adverse     events, to elucidate whether differences in this ratio might have a positive or negative     predictive value in diagnosing atorvastatin muscle toxicity.   "
196177|NCT00414570|"     The objective of this pilot study are (i) to compare response to chemotherapy, time to     disease progression and overall survival in patients with pancreatic cancer who will be     treated with gemcitabine who demonstrate 18F-FLT uptake to those patients who do not     demonstrate 18F-FLT uptake; (ii) to correlate 18F-FLT uptake with hENT1 expression with     biopsy samples where available; (iii)to determine the presence or absence of uptake, the     relative uptake score (RUS) and tumor to background ratios of 18F-FLT in patients with known     carcinoma of the pancreas and assess this uptake in relation to time to disease progression;     and (iv) to demonstrate the safety of 18F-FLT manufactured at the Edmonton PET Centre.   "
196178|NCT00414583|"     More than one million people in Europe suffer from a stroke every day. Normally older people     have a stroke, but also a significant number of younger people between 18 and 55 years.     Usually, these cannot be explained by the classical risk factors such as diabetes, overweight     and high blood pressure. New studies indicate that in about 1 - 2 % of the younger stroke     patients the cause could have been an undiagnosed genetic disease, the so called Fabry     disease. The purpose of this study is to determine in a large number of young stroke     patients, how many strokes were caused by Fabry Disease.   "
196179|NCT00414596|"     This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000     for active treatment of chronic low back pain.   "
196180|NCT00414609|"     The core and extension studies assessed the safety and efficacy of aliskiren when added to     optimized standard therapy in patients that have had a high risk acute myocardial infarction     (heart attack).   "
196181|NCT00414622|"     A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of     GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days     to Participants With Probable Alzheimer’s Disease   "
196182|NCT00414635|"     For people with HIV who are currently taking specific medications (including Sustiva     (efavirenz)) and have no detectable viral load, this study tracks how patients do if they     take their medications for five days of the week compared with seven days of the week.   "
196183|NCT00414648|"     Lymphangioleiomyomatosis (LAM) is a rare lung disease that is caused by genetic mutations. It     results in the uncontrolled growth and proliferation of an unusual type of smooth muscle     cell. These cells invade lung tissue, including the airways, blood vessels, and lymph     vessels, and restrict the flow of air, blood, and lymph, respectively. Respiratory failure,     lung collapse (pneumothorax), and pleural effusions (chylothorax) are hallmarks of the     disease. This study will evaluate the safety and effectiveness of sirolimus, an     immunosuppressive medication, in stabilizing or improving lung function in people with LAM.   "
196184|NCT00414661|"     The purpose of this study is to follow the health of subjects who have previously been     enrolled in studies of CP-690,550 for treatment of their rheumatoid arthritis. Subjects are     only eligible for this study after they have completed all participation in other studies of     CP-690,550.   "
196185|NCT00414687|"     The purpose of this study is to determine whether the study drug is effective in the     long-term treatment of primary or secondary pulmonary hypertension   "
196214|NCT00415090|"     The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1     < 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.   "
196215|NCT00415103|"     The purpose of this trial is to determinate the security, tolerability and efficacy of     aprepitant plus palonosetron versus granisetron in the prevention of nausea and emesis     induced by chemotherapy in patients treated with haematopoietic progenitors transplant.   "
196186|NCT00414700|"     This is a phase III, multicenter, open-label, randomized controlled trial of ChondroCelect®     in an Autologous Chondrocyte Implantation (ACI) procedure compared to the procedure of     microfracture (MF) in the repair of symptomatic cartilage lesions of the knee. Eligible     patients attended two screening visits and were booked for arthroscopy approximately 2 weeks     later. At that time, patients were randomized to either ACI with ChondroCelect® or to MF, a     procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar     tissue. Patients randomized to MF had the procedure performed at the time of their     arthroscopy; those randomized to ACI with ChondroCelect® had their cells harvested during the     arthroscopy and then returned to the clinic approximately 4 weeks later for an open knee     procedure, during which the ACI procedure using ChondroCelect® was performed. Patients     subsequently followed the same rehabilitation program and had follow-up assessments up to 12     months post-surgery. The 12-month visit was the end-of-study visit for the TIG/ACT/01/2000     protocol. Subject to satisfying the eligibility criteria, patients who had participated in     the initial 12 month trial could enter the extension trial. The 12-month visit for the     initial study was the baseline visit for the extension study. During the extension study,     patients have follow-up assessments up to 60 months post-surgery.   "
196187|NCT00414713|"     Recently it has been suggested that a restrictive transfusion of units of Red Cells (URC) may     improve the outcome of ICU patients with anemia. Furthermore, it has been suggested that the     transfusion of URC may be deleterious for the hemostatic process of bleeding lesions, which     suggest that a restrictive transfusion may be valuable in patients which gastrointestinal     bleeding. Transfusion of URC may also increase portal pressure which may be detrimental to     control acute portal hypertensive bleeding.      The aim of the present study is to assess whether a restrictive transfusions may improve the     outcome of patients with acute nonvariceal gastrointestinal bleeding, and also whether such a     restrictive strategy may improve the outcome of bleeding episodes related with portal     hypertension.      The study will be carried out with a prospective, randomized and controlled design comparing     the restrictive transfusion strategy with the usual nonrestrictive transfusional strategy.     Overall 860 patients will be included; 430 in each group.      The main outcome measure will be survival. All deaths occurred within the 30 days after     admission, will be considered. Secondary outcomes will include rebleeding and complications     related to treatment, and related to the bleeding episode itself. Portal pressure will be     measured to assess the influence of the transfusions strategy on fluctuations of this     parameter, and the relationship with the clinical course of bleeding episode.      The study will be performed at the Bleeding Unit of our hospital during a period of 3 years.   "
196188|NCT00414726|"     The purpose of this study is to compare the safety and efficacy of treating individuals with     acute ischemic stroke with normobaric oxygen therapy (NBO, given within 9 hours of symptom     onset), to standard medical treatment.   "
196189|NCT00414739|"     The study analysis the influence of benzalkonium chloride on the density of antigen     presenting Langerhans cells. This is achieved in a double blind randomized study using     in-vivo confocal microscopy to identify and quantify Langerhans cells of the human cornea in     its central and peripheral part. This study design is based on observations with raised     Langerhans cell density after the application of benzalkonium chloride containing eye drops     in glaucoma patients.   "
196192|NCT00414778|"     The purpose of this study is to evaluate safety and pharmacokinetics of a single and multiple     dose of LHT344 in 12 Chinese healthy subjects.      This study is not recruiting subjects in the United States.   "
196193|NCT00414804|"     The primary objective of this study is to compare the efficacy of SCS using the Precision     implantable neurostimulation device and conventional medical treatment (nerve blocks +     physical therapy) in subjects with recently-diagnosed Complex Regional Pain Syndrome (CRPS)     after some more conservative treatments have failed. There are significant numbers of     patients with CRPS in whom conventional treatment is ineffective and SCS is used only as a     last resort. If SCS is effective earlier in the treatment continuum, it would provide a much     needed treatment alternative and increase awareness of the utility of SCS for this     indication. It is also possible that early intervention with SCS may limit disease     progression.   "
196194|NCT00414817|"     Inhaled corticosteroids (ICS) are often prescribed as a treatment for asthma. However, many     individuals who take these medications do not adhere to their prescribed treatment regimen.     The purpose of this study is to evaluate the effectiveness of a telephone-based program at     improving medication adherence among individuals with asthma.   "
196195|NCT00414830|"     The purpose of this study is to determine if prevention of further fractures is possible     through systematic evaluation for osteoporosis in patients with recent hip fracture   "
196196|NCT00414843|"     The purpose of the study is to establish a repository of human bile as a resource for studies     evaluating molecular predictors of biliary cancer risk.   "
196197|NCT00414856|"     This study will assess the safety and tolerability of oral single dose applications of AFQ056     in GERD patients.   "
196198|NCT00414869|"     Chronic liver diseases are often characterized by portal hypertension, a major complication     involving haemodynamic changes due to increased intrahepatic vascular resistance. It has     become well established that nitric oxide (NO) plays a crucial role in the haemodynamic     abnormalities that develop in chronic portal hypertension.      NCX-1000 is a NO-releasing derivative of ursodeoxycholic acid that would compensate for the     defective liver NO production in cirrhosis.      This study intends to demonstrate the desired therapeutic activity (reduction in portal     pressure) in a small number of target patients, to assess the safety and tolerability after     repeated oral administrations of NCX-1000, and to get preliminary pharmacokinetic data in     this population.   "
196216|NCT00415116|"     RATIONALE: Lenalidomide may stop the growth of solid tumors by blocking blood flow to the     tumor. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving lenalidomide together with docetaxel and carboplatin may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when     given together with docetaxel and carboplatin in treating patients with advanced solid     tumors.   "
198183|NCT00441376|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of ThermoDox when     used in combination with radiofrequency ablation (RFA) in the treatment of primary and     metastatic tumors of the liver.   "
196199|NCT00414882|"     The purpose of the study is to see if one plan for identifying and treating tuberculosis (TB)     works better than another in reducing new cases of TB. The first plan is the DOTS program,     which provides free TB treatment to people seeking it. The second plan provides free TB     treatment to people seeking it and involves program staff going door-to-door in communities     to identify new cases of TB, DOTS plus active case-finding program (ACF). Researchers believe     that by detecting TB cases earlier and supervising treatment it will help to prevent     spreading and decrease TB in these areas. The study population will be 200,000 people in 6     communities of Santa Cruz and 14 communities of Northeast Rio de Janeiro, Brazil, receiving     DOTS or DOTS plus ACF. Individuals in the DOTS plus ACF part of the study will be interviewed     2-4 times during a 9 month period. Patients with symptoms will provide a sputum specimen.     Patients identified as having TB will begin treatment and be observed for 6.   "
196200|NCT00414895|"     The goal of this study is to detect AR and CR in the transplanted heart by quantitative     assessment of myocardial blood flow and its constituents by myocardial contrast     echocardiography (MCE). Further we investigate the collateral circulation in these patients.   "
196201|NCT00414908|"     This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen     absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a     run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind     period and a 6-month Open-Label Follow-up.   "
196202|NCT00414921|"     The purpose of this study is to evaluate the safety and efficacy of two     medications——clonidine and methylphenidate——alone or in combination to treat attention     deficit hyperactivity disorder in children ages 4 through 6.   "
196203|NCT00414934|"     18F ion is a positron emitting bone radiopharmaceuticals. The skeletal uptake of 18F relies     on the exchange of hydroxyl ions in the hydroxyapatit crystal which is an indicator of bone     metabolic activity (8). It has good soft tissue clearance and high affinity of to the bone     matrix. It is able to perform a highly sensitive whole-body screening for bone metastases     using a high resolution PET scanner. Therefore, we conduct a prospective study to evaluate     the accuracy and clinical value of 18F PET in staging bone metastases by        1. Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy;        2. Determining the clinical impact of PET results on subsequent patient management.   "
196204|NCT00414947|"     This study will evaluate the bioequivalence as well as rate and extent of absorption of     vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. compared to the imported     vildagliptin tablet in Chinese healthy volunteers.      This trial is not recruiting patients in the United States,   "
196205|NCT00414960|"     To compare the difference of a marker of cellular proliferation in all bronchial biopsy     specimens of former smokers stratified by lung cancer risk, collected before and after     treatment per patient between the enzastaurin and placebo groups.   "
196206|NCT00414973|"     The purpose of this study is to compare the effect of injectable teriparatide to intranasal     salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients     with established osteoporosis   "
196207|NCT00414986|"     The study will randomize 54 primary care practices to two intervention and a comparison     groups. Both interventions will involve an on-site Improvement Facilitator who will assist     the practice in forming an Improvement Team, using rapid-cycle tests of change, and     implementing chronic care office systems for type 2 diabetes and depression. One intervention     is based on complexity science and the other is a traditional QI intervention.   "
196227|NCT00408213|"     This 2 arm study will provide optional continuation of double-blind treatment with CellCept     or placebo, in patients with myasthenia gravis who have achieved good symptom control in     study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with     stable prednisone dosing for the last 4 weeks, can continue on blinded treatment with     CellCept (1g bid) or placebo until the database for WX17798 is locked and unblinded. The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
196208|NCT00414999|"     The formation of new blood vessels (angiogenesis), blood vessel leakage, and inflammation     contribute to the progression of the eye disease, age-related macular degeneration (AMD),     which is the leading cause of irreversible, severe loss of vision in people 55 years of age     and older in the developed world. TG100801 is a new drug that inhibits ocular angiogenesis,     vascular leak, and inflammation in laboratory studies, and may have great utility in the     treatment of diseases such as AMD.      The purpose of this study is to assess the safety, ocular tolerability, and blood     pharmacokinetics of TG100801 at escalating doses in healthy volunteers.   "
196209|NCT00415025|"     RATIONALE: Tests that measure how much saliva is made, hearing, swallowing, voice function,     and quality of life may improve the ability to plan treatment for patients with advanced head     and neck cancer and may help doctors find better ways to treat the cancer.      PURPOSE: This clinical trial is studying the side effects of high-dose intensity-modulated     radiation therapy in treating patients with advanced head and neck cancer.   "
196210|NCT00415038|"     The purpose of this study is to verify the efficacy of Rostafuroxin in the treatment of     essential hypertension and to determine the best effective dose to be administered in the     general hypertensive population and in a subset of this population in which genetic patterns     could be involved in the etiology of essential hypertension.   "
196211|NCT00415051|"     This study is to determine if a vaccine for Rift Valley Fever (RVF) is safe to give to     humans. The study will examine how well the vaccine (RVF MP-12) stimulates the body's immune     response (which fights off infection) and if the vaccine is stable or if the virus used to     make the vaccine changes into a different form once injected into the body. Twenty healthy     volunteers (18-50 years old) will be vaccinated with a single dose of undiluted RVF MP-12,     injected into a muscle.   "
196212|NCT00415064|"     This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for     patients with relapsed or refractory multiple myeloma. The current protocol will enroll     patients with relapsed or refractory multiple myeloma requiring second or third line therapy.     Six patients each will be treated with at one of 4 dose levels in a phase 1 study. All     patients will receive perifosine, lenalidomide and dexamethasone of each 28 day cycle. The     doses of perifosine and lenalidomide will be varied in each group. The dose of dexamethasone     will remain constant.   "
196217|NCT00415129|"     Based on the results from a previous formulation/dosage ranging trial, this phase II     multicenter, open trial was designed to determine the safety and immunogenicity of two     vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in     adults (18 to 60 years and in the elderly (> 60 years) as required by the European Medicines     Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12     months will also be evaluated.   "
196218|NCT00415142|"     The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major     Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on     disability and quality of life in patients with major depressive disorder.To evaluate safety     and tolerability of 24 weeks of additional treatment in patients completing the initial     8-week treatment period.   "
196219|NCT00415155|"     The primary objective of this study is to estimate the time to progressive disease for     patients with advanced hepatocellular cancer who receive LY2181308.   "
196220|NCT00415168|"     Study H3E-MW- S108 is a multicenter, single arm, open-label Phase 2 study to determine the     response rate of pemetrexed plus cisplatin in patients with Stage IV gastric cancer, not     amenable to curative surgery, or recurrence after prior surgery, who have had no prior     chemotherapy. It was planned to enroll approximately 50 patients who qualified for tumor     response population.   "
196221|NCT00415181|"     This study will try to determine whether or not certain genes are responsible for the huge     variation in toxicity and effect observed between patients treated with paclitaxel     (chemotherapeutic drug). Specifically we will study this in patients with ovarian cancer who     receive paclitaxel/carboplatin chemotherapy after primary surgery.   "
196222|NCT00415194|"     This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in     head and neck cancer patients.   "
196223|NCT00408161|"     The purpose of this study is to evaluate the efficacy of prize contingency management (CM) in     reducing in-patient detoxification services for chronic recidivist alcohol-dependent     patients.   "
196224|NCT00408174|"     To establish the efficacy and safety of a new tablet formulation and dosing regimen of     balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with     mildly to moderately active ulcerative colitis after 6 weeks of therapy.   "
196225|NCT00408187|"     The purpose of this study is to determine the safety and efficacy of voclosporin in patients     with plaque psoriasis.   "
196226|NCT00408200|"     The purpose of this study is to examine the overall effectiveness of anti-arrhythmic     medicines (to control heart rhythm) prescribed after an ablation procedure for atrial     fibrillation.   "
196243|NCT00408434|"     An open-label, Phase I, dose escalation study of CS-7017 administered by mouth in sequential     cohorts of 3 to 6 patients with advanced or metastatic malignancies.   "
196228|NCT00408226|"     To determine the toxicities, maximum tolerated dose (MTD) and recommended phase 2 dose of     MKC-1 when administered orally, twice daily for 14 days followed by 7 days without dosing, in     combination with pemetrexed (delivered at its recommended single agent dose) to patients with     advanced solid tumor malignancies. Also, to determine the antitumor activity, based on the     objective response rate and median Progression Free Survival (PFS), of oral MKC-1,     administered on this schedule in combination with pemetrexed to patients with non small cell     lung cancer (NSCLC).   "
196229|NCT00408239|"     Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing     elective primary total knee replacement surgery   "
196230|NCT00408252|"     Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has     antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So     at the light of these pre-clinical and clinical data, it seems interesting and promising to     test SU011248 in these poor prognosis patients.   "
196231|NCT00408265|"     The purpose of this study is to compare the effects of self-help materials for smoking     cessation and self-help materials for smoking cessation plus prize-based contingency     management (CM), in which prize incentives are available for breath and saliva samples that     indicate smoking abstinence, in substance abuse treatment patients who want to quit smoking.   "
196232|NCT00408278|"     Primary objectives        -  To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for          induction and consolidation therapy in patients with APL.        -  To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and          overall survival, as well as on the duration of remission and cumulative incidence of          relapse in low- and intermediate-risk patients with APL.        -  To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation          for high-risk patients (administered as in the original GIMEMA protocols) on the          event-free, disease-free, and overall survival, as well as on the duration of remission          and cumulative incidence of relapse.        -  To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy          in the whole series and in each treatment group in patients with APL.      Secondary objectives      • To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.   "
196233|NCT00408291|"     The purpose of this study is to study with the use of clinical and radiological parameters     the treatment of three-part and four-part fractures with the Winsta PH osteosynthesis device     (Fischer Medical).   "
196234|NCT00408304|"     The purpose of the study is to check whether development of depression as a side effect of     interferon alpha treatment in chronic carriers of hepatitis C can be prevented by omega-3     fatty acids.   "
196235|NCT00408317|"     The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to     placebo for the correction of fat and protein malabsorption in participants with cystic     fibrosis (CF) and exocrine pancreatic insufficiency (EPI). This study is sponsored by Aptalis     Pharma (formerly Axcan).   "
196236|NCT00408330|"     This study is to determine whether a medication on the market for other indications is     effective and safe in treating seborrheic dermatitis of the face.   "
196269|NCT00408785|"     This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group     comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for     the Chinese patients with glabellar lines. The subjects will receive a single intramuscular     treatment consisting of 5 injections of either BOTOX? 20U or placebo.   "
196237|NCT00408356|"     Zinc deficiency has been found to be widespread among children in developing     countries.Clinical and field studies have consistently observed an association between zinc     deficiency and higher rates of infectious diseases, including skin infections, diarrhea,     respiratory infections, malaria, and delayed wound healing. Based upon the impact of zinc     deficiency on diarrheal disease alone, it is estimated correction of this deficiency could     save 450,000 under-five deaths annually. What is the physiological explanation for this? Zinc     has been identified to play critical roles in metallo-enzymes, poly-ribosomes, the cell     membrane, and cellular function, leading to the understanding that it also plays a central     role in cellular growth and in the function of the immune system. With zinc deficiency     epithelial barriers are compromised and multiple components of the immune system malfunction.     The obvious conclusion is that zinc deficiency results in diminished immunological competence     that in turn leads to an increased risk for infectious diseases and greater severity of     illnesses. Whether this is the case requires substantiation. A related, but more pragmatic     question is the value added of zinc supplementation in addition to zinc treatment. The     scale-up strategy being pursued in Bangladesh is to provide zinc for 10 days as a treatment     at the time of a diarrhea episode. This is in accordance with recently revised WHO     recommendations for the treatment of childhood diarrhea (WHO, in press). Can we conclude     there is no or minimal value added to continuing zinc as a dietary supplement in zinc     deficient children following an acute episode? If there is added benefit, can this be     explained by improvement in zinc levels and/or immune function? The aims of this study     include:1. In children six to twenty-four months of age with an acute episode of diarrhea     attributable to enterotoxigenic E. coli (ETEC), to describe the innate and adaptive immune     response to zinc and to relate changes in immune function or zinc status to the occurrence of     repeat infectious illnesses over a 9 month period of observation. 2a. In children six to     twenty-four months of age with an acute episode of diarrhea with enterotoxigenic E. coli     (ETEC), and other non-ETEC diarrhea, to determine the value added of zinc supplementation     following treatment in terms of the future occurrence of ACD, ARI, and impetigo and 2b. to     assess the impact of zinc supplementation on health services utilization and household     expenditures for ACD, ARI and impetigo.   "
196238|NCT00408369|"     To evaluate the prophylactic activity of orally administered DB289 against Plasmodium     falciparum in non-immune healthy volunteers who are challenged by the bite of five P.     falciparum-infected Anopheles stephensi mosquitoes   "
196239|NCT00408382|"     To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of     characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying     coronary artery disease   "
196240|NCT00408395|"     This is a study of the safety and immunogenicity of three commercially available influenza     vaccines in children.   "
196241|NCT00408408|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood     flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab     after surgery may kill any tumor cells that remain after surgery. It is not yet known which     chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer.      PURPOSE: This randomized phase III trial is studying six different chemotherapy regimens to     compare how well they work with or without bevacizumab in treating women with stage I, stage     II, or stage IIIA breast cancer that can be removed by surgery.   "
196242|NCT00408421|"     The primary purpose of this study is to determine if duloxetine reduces pain severity in     patients with osteoarthritis knee pain.   "
196244|NCT00408447|"     The primary purpose of this study is to see if giving lower doses of chemotherapy (moderately     ablative) will result in successful bone marrow replacement without as severe side-effects     but with permanent control of the disease. Patients will receive a chemotherapy regimen with     busulfan, fludarabine, and alemtuzumab followed by an infusion of stem cells, either from a     family-related or cord-blood matched donor.   "
196245|NCT00408460|"     This phase II trial is studying how well giving imatinib mesylate together with paclitaxel     works in treating older patients with stage IIIB or stage IV non-small cell lung cancer.     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving imatinib mesylate together with paclitaxel may kill more tumor cells   "
196246|NCT00408473|"     The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in     the prevention of recurrent AF during 9 months of active treatment compared to placebo in     patients with only one documented AF episode.   "
196247|NCT00408499|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Giving erlotinib together     with cetuximab may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib and     cetuximab and to see how well they work in treating patients with advanced solid tumors or     progressive or recurrent stage III or stage IV non-small cell lung cancer.   "
196248|NCT00408512|"     Background: The use of thiazide diuretics in the treatment of hypertension (HT) is widely     considered a first line treatment, given the efficacy and low cost of this class of drugs.     This indication is not unanimous, because thiazides can cause metabolic alterations and other     side effects increasing cardiac and cerebrovascular risk, which reduce compliance to     treatment and increase health care system cost. However, large intervention trials in HT     suggest that the improvement in cardiovascular prognosis of HT patients depends more on     follow-up procedures than on type of drug used. Furthermore, the investigators have     documented improved compliance to antihypertensive therapy by implementing cooperation     between general practitioners (GPs) and HT specialists.      Objectives: In a multicenter, open label randomized study the investigators will compare the     persistence on therapy of thiazides versus other treatments, as a first line antihypertensive     therapy, in a clinical setting characterized by a strict cooperation between GPs and HT     specialist. The investigators will also analyse candidate genes with impact on drug-induced     metabolic alterations to elucidate the pathophysiology of these phenomena.      Methods: 260 GPs will recruit 2600 hypertensive patients with indication to pharmacological     treatment and randomise them to starting treatment with chlortalidone (12.5 to 25 mg daily,     1300 pts) or a GP decided single drug (excluding thiazides) or combination therapy at highest     tolerated dose. In both groups any other class of antihypertensive drugs can be added over     time in order to achieve blood pressure control (<140/90 mmHg). Follow-up will last 2 years.     Blood sample and urine analyses, carotid and cardiac ultrasound will be performed at baseline     and scheduled time points. Genotyping will be performed by sequencing. Data will be collected     and stored using a web based centralized Case Report Form (CRF) Expected results: Results     will highlight whether a follow-up strategy based on tight cooperation between GPs and HT     specialists can allow the use of thiazides as first line antihypertensive therapy without any     negative effect on persistence, adherence and efficacy of the treatment. These data can be     used to reduce total burden of the Health Care System in HT by replacing more expensive drugs     with diuretics in the 50% of hypertensive patients, who do not receive this class of drugs.     Furthermore, the pharmacogenetic approach may clarify the pathophysiological mechanisms of     drug-induced metabolic side effects   "
196249|NCT00408525|"     The purpose of the study is to examine patterns of brain activity in people who are at risk     for memory problems (e.g., Alzheimer's disease or dementia)before and after the medication     donepezil. Although genetic testing will be done, the results will not be shared with study     participants.      Once the genetic testing is completed subjects may continue to the second phase of the study.     During this time they will be asked to take the medication donepezil (which is approved by     the FDA for the treatment of Alzheimer's disease).      Donepezil is not FDA approved for healthy volunteers and is therefore considered     investigational in this study.   "
196250|NCT00408538|"     This study is the first to try this product in the rectum of humans. This study is only to     find out if the gel is safe for use in the rectum, not to see if the gel works. Information     gathered from this study will help investigators decide whether this gel is safe enough to     move onto the next phase of studies.      Information gathered from this study will also help investigators determine what participants     did and did not like about the product and what types of products people might want to use in     the future. Currently condoms and abstinence are the only methods proven to prevent the     spread of HIV sexually.   "
196251|NCT00408551|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Internal radiation uses     radioactive material placed directly into or near a tumor to kill tumor cells. Giving     chemotherapy together with internal radiation may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving chemotherapy together with internal     radiation works in treating patients with colorectal cancer that has spread to the liver.   "
196252|NCT00408564|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     gemcitabine, oxaliplatin, and capecitabine, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when     chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be     resistant to chemotherapy. Giving cetuximab together with chemotherapy may reduce drug     resistance and allow the tumor cells to be killed. Giving cetuximab and chemotherapy before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed. Radiation therapy uses high-energy x-rays to kill tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with oxaliplatin     and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works     in treating patients with locally advanced, nonmetastatic pancreatic cancer that cannot be     removed by surgery.   "
196279|NCT00415324|"     This trial is studying the side effects and best dose of eribulin mesylate and cisplatin in     treating patients with advanced solid tumors.Drugs used in chemotherapy, such as eribulin     mesylate and cisplatin, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving more than one drug (combination     chemotherapy) may kill more tumor cells.   "
196253|NCT00408577|"     Impaired glucose tolerance or mild glucose elevations in the non-diabetic range are     associated with increased cardiovascular disease and recent studies suggested the need to     detect these glucose abnormalities early in the post-infarction period. Although in the last     ten years procedures of coronary revascularisation have dramatically improved the outcome of     non diabetic patients affected by ischemic heart disease, these procedures are less effective     in patients with type 2 diabetes mellitus and IGT. Possible causes of worse prognosis in     these patients could be related to the presence of hyperinsulinemia and insulin resistance     due to the well known effect of insulin to increase neointimal tissue proliferation and     in-stent restenosis, by stimulating vascular smooth muscle cell growth factors and migration.     In addition, it is well known that endothelial dysfunction is an early functional disturbance     in the development of atherosclerotic lesions. The impairment of eNOS action might change the     turnover rate of eNOS or nitric oxide production and action influencing nitric oxide     signalling, apoptosis cascade and angiogenesis. All these factors can contribute to     endothelial dysfunction to a certain extent, and accelerate atherosclerosis with increased     risk for cardiovascular disease.      The constitutively expressed eNOS, is likely to be the major contributors to whole-body     nitric oxide production. It is interesting to note that a region of chromosome 7q seems to     influence both insulin resistance and blood pressure, suggesting that this locus may broadly     influence traits associated with insulin resistance.      L-arginine is an essential amino acid and its availability is important for the normal     endothelial cell function and its intracellular reduction may contribute to the dysfunctional     endothelial state. It is well known that L-arginine is as a precursor for nitric oxide and     both in vitro and in vivo studies have demonstrated that L-arginine can augment vascular     dilation under certain conditions.      Our hypothesis is to evaluate the modulating effect of L-arginine on metabolic, endothelial     variables and on myocardial function in patients with cardiovascular disease.   "
196254|NCT00408590|"     RATIONALE: A gene-modified virus may be able to kill tumor cells without damaging normal     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of an attenuated     oncolytic measles virus therapy and oncolytic virus therapy in treating patients with     progressive, recurrent, or refractory ovarian epithelial cancer or primary peritoneal cancer     (measles virus vaccine therapy study closed as of 06/02/2008).   "
196255|NCT00408603|"     The purpose of this study is to evaluate the objective response rate, safety and identify     potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin     injection given on a 28-day cycle.   "
196256|NCT00408616|"     The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces     the hayfever symptoms and the use of symptom relieving medications in children during the     grass pollen season   "
196257|NCT00408629|"     This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed     to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal     antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis     (UC).   "
196268|NCT00408772|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of tumor cells by blocking blood flow to the tumor. Radiofrequency ablation uses a     high-frequency, electric current to kill tumor cells. Giving chemotherapy and bevacizumab     before surgery or radiofrequency ablation may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine     together with bevacizumab followed by surgery and/or radiofrequency ablation works in     treating patients with colorectal cancer that has spread to the liver and cannot be removed     by surgery.   "
196258|NCT00408642|"     In southern Africa, TB is the most common first AIDS-defining condition. Initiating     Antiretroviral therapy (ART) in HIV positive TB patients will lead to the inclusion of the     majority of HIV/AIDS patients currently fulfilling the criteria for therapy. Establishing an     effective intervention to increase treatment adherence in this group is essential for the     successful roll out of ART in the region. This proposed randomized controlled study aims to     compare the effectiveness of two adherence support programmes (ASP) for use in patients with     HIV-related TB in the context of CAPRISA AIDS Treatment (CAT)programme in KwaZulu-Natal,     South Africa; the enhanced adherence support programme (E-ASP) or the standard adherence     support programme (S-ASP).      S-ASP consists of three counselor presented, group education sessions. E-ASP is an extension     of S-ASP and is based on the Information-Motivation-Behavioral Skills (IMB) Model of     Adherence to Antiretroviral Therapy, a theoretical model initially developed to reduce HIV     risk behavior. The E-ASP will consist of several interconnected components: 1) development     and maintenance of an educational and supportive milieu at the CDC Clinic, 2) provision of     five structured educational, support and behavioral skills building sessions, and (3) three     weekly ART planning sessions.   "
196259|NCT00408655|"     This phase I trial is studying the side effects and best dose of temsirolimus, carboplatin,     and paclitaxel in treating patients with advanced solid tumors. Temsirolimus may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     temsirolimus together with chemotherapy may kill more tumor cells.   "
196260|NCT00408668|"     The purpose of this study is to test three candidate malaria vaccines in new combinations to     assess their efficacy at preventing malaria infection and triggering immune responses against     malaria.   "
196261|NCT00408681|"     RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host     disease caused by a donor stem cell transplant.      PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute     intestinal graft-versus-host-disease after donor stem cell transplant.   "
196262|NCT00408694|"     This phase II trial is studying how well giving bevacizumab together with cisplatin,     radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III,     stage IVA, or stage IVB nasopharyngeal cancer. Monoclonal antibodies, such as bevacizumab,     can block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Bevacizumab may also stop the growth of nasopharyngeal cancer by blocking blood flow to the     tumor. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab     together with chemotherapy and radiation therapy may kill more tumor cells.   "
196263|NCT00408707|"     The purpose of this study is to examine whether local infiltration analgesia (LIA) with     Ropivacaine and adrenaline is effective in the treatment of postoperative pain after total     knee arthroplasty.   "
196264|NCT00408720|"     The purpose of this study is to compare the newly released Spectral OCT/SLO (OTI, Toronto,     Canada) with the Zeiss Stratus OCT (Carl-Zeiss Meditec, Dublin, CA) with regards to the     quality of the images obtained as well as the ease of use.   "
196280|NCT00415337|"     1. Endobronchial ultrasonography (EBUS) is useful in localizing peripheral lung lesions.          The EBUS, further combined with the guide sheath (GS) technique, has been reported to          increase the yield of transbronchial biopsy. However, there are no reports comparing the          GS technique and the traditional EBUS technique in diagnosing the peripheral lung tumor.        2. Previous reports have revealed that several characteristic echoic patterns correlate          well with the histopathological findings of benign and malignant lesions. Therefore,          EBUS may also be useful in the differential diagnosis of malignant lesions of the lung.   "
196265|NCT00408733|"     Recent studies have demonstrated that patients sub-optimally understand hospital discharge     medication instructions Health literacy has been shown to be an important factor in patient     understanding of medical information , and following medication instructions.      The primary aim of this project is to test the efficacy of a low-literacy discharge     medication education tool on medication adherence, and patient knowledge and understanding of     inpatient discharge medications, in a low-income population with low health literacy levels.     This evaluation is a prospective trial with patients randomly assigned to either receiving     this tool or receiving the current standard of care. Given the complexity of the discharge     medication regimen for the conditions of congestive heart failure (CHF) and coronary artery     disease (CAD), and the proven effectiveness of these medications in the post discharge     period, this trial will focus on the subpopulation of patients hospitalized with these two     conditions.   "
196266|NCT00408746|"     Preterm infants account for 6 % of all live-births in western societies. Scientific evidence     can be found for altered palatal morphology in the short term among preterm children. Oral     intubation and orogastric feeding might be contributing factors to these alterations, but it     has not been examined whether in the absence of these interventions preterm infants' palates     are altered a priori as compared to term infants, e.g. due to immaturity of the bones or due     to immaturity of oral function. Because of contradictory results, lack of longitudinal and     high quality standard studies, the scientific evidence is also to weak to answer the question     whether premature birth without or with a history of orotracheal intubation and orogastric     feeding causes permanent alteration of orofacial development. The aim of the present study,     therefore is to investigate in consideration of perinatal, biometrical, nutritional,     functional and parental parameters.   "
196267|NCT00408759|"     xerostomia develops in all patients with head and neck cancer following radiotherapy. it     consists one of the main side effects which affects quality of life. currently, there is no     standard of care for treating this condition. parasympathomimetic drugs may help but carry     significant side effects.      hypnosis may affect autonomic function such as salivation, in healthy people.in this study we     will explore the efficacy of hypnosis in improving salivation, in the patient population.   "
196289|NCT00415454|"     The primary purpose of this phase I study is to determine the safety of combining     replication-competent adenovirus-mediated suicide gene therapy with chemoradiotherapy in     patients with non-metastatic pancreatic cancer.   "
196270|NCT00415207|"     This study will try to determine whether or not certain genes are responsible for the huge     variation in toxicity and effect observed between patients treated with paclitaxel     (chemotherapeutic drug). Specifically we will study this retrospectively in patients who     participated in clinical trials that are now closed. All patients had ovarian cancer and     received paclitaxel/carboplatin chemotherapy after primary surgery.   "
196271|NCT00415220|"     The purpose of this study was to compare standardized chiropractic treatment (spinal     manipulation) to back surgery (microdiscectomy) for patients with sciatica secondary to     lumbar herniated disc refractory to medical management.   "
196272|NCT00415233|"     RATIONALE: Radioactive iodine uses radiation to kill tumor cells. Giving iodine I 131 with or     without thyroid-stimulating hormone after surgery may kill any tumor cells that remain after     surgery. It is not yet known which dose of iodine I 131 is more effective when given with or     without thyroid-stimulating hormone in treating thyroid cancer.      PURPOSE: This randomized phase III trial is studying two different doses of iodine I 131 to     compare how well they work when given with or without thyroid-stimulating hormone in treating     patients who have undergone surgery for thyroid cancer.   "
196273|NCT00415246|"     To identify the proportion of patients remaining medically castrated (testosterone level < 50     ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR)     formulation of triptorelin.   "
196274|NCT00415259|"     It is hypothesised that laterally wedged insoles will result in reduced knee pain and     cartilage volume loss after 12 months of wear, compared to control insoles. People with     symptomatic knee osteoarthritis will be recruited from the community and randomised to wear     either laterally wedged insoles or control insoles for 12 months. Patients will be assessed     at baseline and at 12 months.   "
196275|NCT00415272|"     Our study aims to investigate the benefits of an outpatient pulmonary rehabilitation program     in a population of subjects with fibrotic interstitial lung disease. Our hypothesis is that     pulmonary rehabilitation will lead to improvements in quality of life, breathlessness,     exercise capacity and pulmonary function in this patient population.   "
196276|NCT00415285|"     The purpose of this study is to identify new chemotherapy treatment regimens with better     response rates and to find out if the combination of docetaxel and capecitabine can shrink     the size of breast tumors and preserve the breast.   "
196277|NCT00415298|"     RATIONALE: Drugs used in chemotherapy, such as AP5346 and oxaliplatin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.      PURPOSE: This randomized clinical trial is studying the dose of AP5346 to see how well it     works compared with the dose of oxaliplatin in treating patients with metastatic and/or     unresectable recurrent head and neck cancer.   "
196278|NCT00415311|"     This is a multicenter, open-label, randomized, Phase 1B study evaluating liver transplant     recipients receiving rhMBL (2 cohorts) or without rhMBL (1 cohort).   "
196281|NCT00415350|"     1. SUMMARY      Rationale: Patients with bronchiectasis often experience lower respiratory tract infections     with progression of symptoms and decline in quality of life. Macrolides, as has been shown in     panbronchiolitis and cystic fibrosis, may break or weaken the link between infection and     inflammation resulting in an improvement of symptoms. Also the number of exacerbations may     lowered.      Objective: A reduction in number of infective exacerbations and improvement in lung function     by AZT treatment are the primary objectives. Secondary objectives that will be evaluated are:     symptoms score, quality of life, inflammatory parameters, bacterial colonisation, and adverse     events.      Study design: Randomised double blind multicenter study in the Netherlands. Patients will be     stratified for colonisation with P.aeruginosa.      Study population: Patients with bronchiectasis demonstrated by high-resolution computed     tomography (HR-CT) scan or bronchography.      Intervention: Patients receive Azithromycin 250mg(p.o.) once daily or placebo.      Main study parameters/endpoints: Reduction in number exacerbations, defined as increase     symptoms such as dyspnoea, coughing, and sputum production for which a course of prednisolone     and/or antibiotic is needed. Change in lung function parameters (forced expiratory volume in     1 second [FEV1], forced vital capacity [FVC]) measured by spirometry is the other primary     endpoint.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The risk of participating in this study is low. Laboratory, radiographic     examinations, and pulmonary function tests are commonly used as diagnostic procedures during     outpatients visits and during exacerbations. Adverse effects in maintenance treatment with     AZT are usually mild and mainly gastrointestinal. Sometimes rash and abnormal liver function     tests are observed. A better quality of life will probably be the beneficial effect of long     term treatment with AZT. This will be achieved by a reduction in respiratory and     non-respiratory symptoms and number of exacerbations.   "
196282|NCT00415363|"     This study is a multinational study to compare enzastaurin versus placebo in the treatment of     patients with brain metastases of lung cancer. Approximately 108 patients will be randomly     assigned to receive either enzastaurin or placebo after having completed whole brain     radiotherapy.   "
196283|NCT00415376|"     RATIONALE: Anticonvulsant drugs, such as levetiracetam, may help control seizures caused by     brain metastases.      PURPOSE: This clinical trial is studying the side effects and how well levetiracetam works in     treating patients with seizures caused by brain metastases.   "
196284|NCT00415389|"     The purposes of this study are to determine the effectiveness of an interactive stroke     educational program compared to standard educational materials and usual care, to increase     stroke knowledge, and to improve emergency room arrival times upon onset of stroke symptoms.   "
196285|NCT00415402|"     The purpose of this study is to determine whether a weekly supplement of vitamin D to low     birth weight term infants will reduce their mortality and hospital admissions and improve     their immunity.   "
196286|NCT00415415|"     Coronary heart disease (CHD) is the leading cause of deaths that are related to     cardiovascular disease in the United States, and Mississippi's CHD mortality rate is the     highest in the nation. This study will examine data from the Jackson Heart Study to determine     the effect of socioeconomic status and psychosocial factors on CHD risk in African Americans     in Mississippi.   "
196287|NCT00415428|"     The overall objective is to increase the adherence to national guidelines for patients with     established CVD and/or Type 2 diabetes by means of repeated post-graduate educational     meetings and regular evaluation of the optimisation initiatives, demonstrated by improvement     of goal attainment in general practice.   "
196288|NCT00415441|"     The purpose of this study is to investigate whether a physiotherapy program reduces pain and     improves disability and quality-of-life in people with chronic shoulder pain.      The main study hypotheses are that (i) A 10-week physiotherapy treatment will result in     significantly greater reductions in pain and disability than placebo treatment in individuals     with chronic shoulder pain (ii) Improvements in pain and disability following a 10-week     physiotherapy treatment will be maintained at a 3-month follow-up.   "
196290|NCT00415467|"     The goals of this study are to evaluate each of the following items:        1. Time to recurrence in patients receiving brachytherapy with the GliaSite RTS        2. Overall survival (OS) in patients with malignant brain tumors who are undergoing          surgical resection and brachytherapy treatment with the GliaSite® Radiation Therapy          System (RTS).        3. Incidence of serious adverse events in patients treated with GliaSite RTS   "
196291|NCT00415493|"     This study seeks to compare patients with vasomotor rhinitis (perennial nonallergic     rhinitis, idiopathic rhinitis) with normal controls with respect to their nasal     physiologic reactivity to cold air challenge. Ten vasomotor rhinitis (VMR) patients with     nasal symptoms triggered predominantly by cold air, four VMR patients with symptoms triggered     predominantly by chemicals, and ten nonallergic, non-rhinitic control subjects will be     studied.   "
196292|NCT00415506|"     The purpose of this study is to assess the safety and tolerability of Rituximab in refractory     scleritis and non-infectious orbital inflammation.   "
196293|NCT00415519|"     The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via     intravenous drip once a day in patients with ALS whose severity is classified as grade III,     based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24     weeks administration in double-blind, placebo-controlled manner. And in addition, this study     will be performed to examine the safety of MCI-186 to ALS patients who met severity     classification III.   "
196294|NCT00415532|"     This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label,     52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia     Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must     complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible     after the initiation of romiplostim. After the completion or discontinuation of the study     treatment period, any participant who does not transfer in to another romiplostim study will     complete a 6-month Safety Follow-up period.   "
196295|NCT00415545|"     Heart failure patients living in rural areas usually do not have adequate access to formal     heart failure management programs. This study will compare two versions of an educational     intervention aimed at improving self-care management techniques among individuals with heart     failure who are living in rural areas.   "
196335|NCT00419445|"     This study will be a randomized, double-blind, placebo-controlled crossover study to assess     the effects of GTS21 (25 mg three times a day (tid), 75 mg tid, 150 mg tid) compared to     placebo in non-smoking adults aged 18-55 with a diagnosis of ADHD, any subtype.   "
196336|NCT00419458|"     The purpose of this study is to determine if inspiratory muscle strength training will     increase the proportion of ventilator dependent patients weaned versus Sham treated patients.   "
196296|NCT00418938|"     This is a multi-center, open-label, randomized, phase 2, two-arm clinical trial to be     conducted in the United States. Approximately 210 eligible KRAS wild-type expressing     metastatic colorectal cancer subjects who have failed first-line oxaliplatin-based     chemotherapy (with at least 4 doses of oxaliplatin-based chemotherapy) with at least 4 doses     of bevacizumab (failure is defined as toxicity due to oxaliplatin-based chemotherapy or     progression of disease on first-line treatment) will be randomized in a 1:1 ratio to receive     either a once-every-two-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg or a Q2W FOLFIRI     regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and     institutional standard of care).   "
196297|NCT00418951|"     The goal of this clinical research study is to compare the effectiveness of liposomal     amphotericin B given three times per week , versus liposomal amphotericin B given once per     week, versus oral voriconazole in the prevention of fungal infections in patients with acute     myeloid leukemia (AML) or myelodysplastic syndromes MDS who are receiving chemotherapy. The     safety of these treatments will also be studied and compared.   "
196298|NCT00418964|"     The objective of this prospective study is to assess the clinical, functional and     radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone     graft, Single bundle hamstring graft and anatomical Double bundle graft in terms of pain,     swelling, mobility, quadriceps girth size, stability, proprioception, bone mineral density     and functional status.   "
196299|NCT00418977|"     This study will compare the effectiveness of two therapies to treat early signs of anorexia     nervosa in adolescents.   "
196300|NCT00418990|"     The purpose of this clinical trial is to determine if administration of a daily chewable     multivitamin-mineral supplement (Monday - Friday when school is in session) given to children     (third through sixth graders) during the academic school year will lead to improved academic     performance.   "
196301|NCT00419003|"     This study is examining the safety and effectiveness of two medications, ketamine and     riluzole, in treating patients with treatment resistant major depressive disorder. This study     will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing     the potential side effects associated with ketamine.   "
196302|NCT00419016|"     A family study of the negative association betweeen schizophrenia and cancer   "
196303|NCT00419029|"     The goal of this randomized controlled trial is to evaluate the efficacy of     telephone-administered motivational interviewing (TAMI) to enhance VA mental health treatment     engagement among veterans of Operations Enduring Freedom (OEF) and Iraqi Freedom (OIF) who     screen positive for mental health disorders on telephone assessment. The investigators will     evaluate whether TAMI results in improved mental health treatment engagement, decreased     mental health symptoms and increased quality of life among OEF/OIF veterans with mental     health disorders. The long-term aim of this study is to conduct rapid assessment and     intervention to prevent chronic mental illness and associated disability among our newest     generation of veterans.   "
196304|NCT00419042|"     The purpose of this study is in non small-cell lung cancer stage IV et IIIB (T4 with pleural     effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first     line followed by Erlotinib when progression versus Erlotinib first line followed by     Gemcitabine when progression   "
196305|NCT00419055|"     To determine the safety and feasibility of same day discharge after elective coronary     percutaneous intervention in a selected stable patient population. The hypothesis to be     tested is that in an appropriately selected stable coronary artery disease population post     percutaneous coronary intervention, early discharge is safe and feasible.   "
196307|NCT00419081|"     The purpose of this study is to determine whether Forodesine Hydrochloride is effective in     treating patients with relapsed/refractory precursor T-Lymphoblastic Leukemia/Lymphoma who     have failed two or more prior treatment regimens.   "
196308|NCT00419094|"     The primary objective of this study is to assess the efficacy of two doses of Keppra XR     compared with a historical control as the placebo, in the monotherapy treatment of partial     onset seizures.   "
196309|NCT00419107|"     Diabetes is more frequent in women with Turner syndrome. The purpose of this study is to see,     in what ways the glucose metabolism is different in this study population. The hypothesis is     that women with Turner Syndrome have an impaired insulin production (beta cell function).   "
196310|NCT00419120|"     Subjects with neurogenic bladder secondary to spina bifida refractory to medical treatment     will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous     neo-bladder construct will significantly increase bladder compliance.   "
196311|NCT00419133|"     The purpose of this study is to compare the safety and immunogenicity of one and two doses of     the killed oral cholera vaccine.   "
196312|NCT00419146|"     The purpose of this trial is to study the effect of adding the omega-3 fatty acid EPA and/or     Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related     psychoses.   "
196313|NCT00419159|"     To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day)     everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite     prior treatment with targeted therapy and chemotherapy.   "
196314|NCT00419172|"     The study will consist of two open-label periods, a Treatment Period I (deferasirox) and a     Treatment Period II (rifampicin+deferasirox). At least 18 subjects are expected to complete     both treatment periods as per protocol. For all subjects, in addition to the two treatment     periods, there will be a 21 day screening period, one baseline evaluation (the day preceding     deferasirox administration in Treatment Period I), and an end-of-study evaluation (EOS).     Study subjects will be required to remain in the unit from Day -1 until Day 17. EOS     evaluation (final safety assessment) will be performed 7-10 days after the last dose of     rifampicin.   "
196315|NCT00419185|"     To evaluate the anatomical and visual outcomes after vitrectomy and internal limiting     membrane (ILM) peeling with indocyanine green (ICG) or trypan blue (TB) for idiopathic     macular hole repair in a prospective randomized trial.   "
196337|NCT00419471|"     This study aimed to evaluate the efficacy and safety of escitalopram in the treatment of     depressive patients with acute coronary artery syndrome (CAS).   "
196316|NCT00419198|"     We previously demonstrated that postconditioning by coronary angioplasty can decrease infarct     size (as measured by cardiac enzyme release) in patients with ongoing acute myocardial     infarction. It is currently unknown whether postconditioning actually decreases or simply     delays myocardial cell death during reperfusion. In addition, the long term effects of     postconditioning on recovery of myocardial contraction remains elusive. The objective of the     present study is to determine whether infarct size reduction by angioplasty postconditioning     is maintained at 6 months and whether functional recovery is improved at one year     post-infarction.   "
196317|NCT00419211|"     To refine, implement and evaluate a motivationally-tailored exercise intervention for     increasing physical activity and mental health during pregnancy and the postpartum.   "
196318|NCT00419224|"     The purpose of this study is to determine whether influenza vaccination protects patients who     receive a certain type of bone marrow transplantation.   "
196319|NCT00419237|"     The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as     measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic     impairment and in healthy subjects following a single oral inhaled dose of GW685698X. From     the study results it should be possible to assess if there is an altered Risk: Benefit in     patients with moderate hepatic impairment   "
196320|NCT00419250|"     The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum     tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation     schedule in subjects with relapsed or refractory B-cell CLL.   "
196321|NCT00419263|"     This is a study for patients with flu who also have a fever as well as other flu symptoms.     Patients must have had symptoms for less than 48 hours in order to participate. Patients will     have two out of three chances of getting an active study treatment and the other third will     receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the     inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to     be seen 5 more times after they are enrolled in the study.   "
196322|NCT00419276|"     To determine if following total knee replacement, putting local anesthetic—or numbing     medication—for five days through a tiny tube next to the nerves that go to the knee will     decrease the time that patients need to spend in the hospital.   "
196323|NCT00419289|"     Patients with Chronic Obstructive Pulmonary Disease (COPD) may benefit from an 8-week     pulmonary rehabilitation programme. However, the effect of the programme tends to attenuate     with time. Patients who complete the programme are randomized to continued rehabilitation     follow-up and control follow-up.   "
196324|NCT00419302|"     This trial was designed to compare meal related inhalation of Technosphere/Insulin to     subcutaneous regular insulin in patients with type 2 diabetes.   "
196325|NCT00419315|"     A randomized study of Alcohol Care Management for the treatment of alcohol dependence in     primary care settings.   "
196326|NCT00419328|"     The main objective of the trial is to explore the safety and biological activity of NGR-hTNF.     The safety will be established by clinical and laboratory assessment. The biological activity     will be evaluated by DCE-MRI with contrast media.   "
196327|NCT00419341|"     The objective of this study is to assess the efficacy, tolerability, safety and     pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).   "
196328|NCT00419354|"     1 To examine whether right ventricular pacing has an impact on tricuspid regurgitation     grade that is related to pacing rather than to valve closure interference by the electrode.   "
196407|NCT00420407|"     Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of     resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and     mortality in critically ill patients following trauma.   "
196329|NCT00419367|"     In an effort to allow patients continued access to vorinostat outside of the base study,     patients that are actively receiving study medication will discontinue from this study and     receive vorinostat via another method supported by the SPONSOR (e.g. Named Patient Program     (NPP)). For those institutions that do not allow receipt of an investigational therapy     outside of a clinical trial, patients that are actively receiving study medication and      continue to meet eligibility will transition to an extension phase of the study and the base     study will be closed.      The extension phase will begin as soon as the protocol amendment is implemented.   "
196330|NCT00419380|"     The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear     drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the     new drug for any problems related to the medication. Patients are being asked to be in this     study because they had tubes placed for the treatment of chronic ear infection and the     tube(s) are now clogged. Clogged tubes are a common problem found in children with tubes.     This problem occasionally is improved with ear drops like Floxin®. However, it is frequently     not improved even after this standard ear drop treatment.   "
196331|NCT00419393|"     To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term     safety of Keppra XR in subjects with partial onset seizures.   "
196332|NCT00419406|"     Atopic dermatitis (AD) is a very common disorder that is characterized by pruritic     inflammatory skin lesions, with patients usually having an individual or family history of     atopic diseases in their background. Phototherapy is among the first-line approaches in the     management of AD. In this context, a variety of studies have shown a beneficial effect of     natural or artificial UV radiation in atopic dermatitis (AD). The past ten years have seen     the introduction of new phototherapeutic regimens for AD, including UVA1 and NB-UVB.UVA1     seems to be more effective than the above mentioned broadband spectra, in particular in acute     severe AD. The aim of the present study is the comparison of UVA1 and NB-UVB phototherapy in     the treatment of AD. Additionally, the course of several cytokines, human beta-defensins, and     SMAD-proteins will be evaluated during the course of treatment.   "
196333|NCT00419419|"     The purpose of this research study is to test the safety, tolerability, and effectiveness of     Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase     blood flow to the fingers.   "
196334|NCT00419432|"     The purpose of this pilot trial is to determine whether the addition of gait laboratory     analysis for surgical decision making, compared with the use of observational analysis alone,     results in improved functional outcomes in ambulatory children with cerebral palsy undergoing     multi-level lower extremity orthopaedic surgery.   "
196338|NCT00419484|"     We want to investigate the effects of pioglitazone on cardiovascular events in Japanese     patients with type 2 diabetes.   "
196339|NCT00419497|"     The purpose of this study is to determine whether a paleolithic diet improves glucose     tolerance and insulin sensitivity in people with coronary heart disease and impaired glucose     tolerance.   "
196340|NCT00419510|"     The objectives of this study are to develop a Culturally Tailored Genetic (CTGC) protocol for     African American women and evaluate its impact on decision making and satisfaction about     BRCA1/2 testing, quality of life, and cancer control practices compared to Standard Genetic     Counseling (SGC). A secondary objective of this study is to identify African American women     who are most and least likely to benefit from CTGC vs. SGC.   "
196341|NCT00419536|"     This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single     agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to     characterize the safety, tolerability, biologic activity and pharmacokinetic profile.   "
196342|NCT00419549|"     ERCP is a diagnostic and therapeutic procedure that is required in patients with suspected     common bile duct stone, malignant biliary obstruction, biliary fistula, etc. Pancreatitis may     occur as a complication of this procedure after about 5-10% of the ERCP procedures. This     complication manifests as persisting pain 24 hours or more after ERCP, along with raised     levels of pancreatic enzymes in the blood. Most of the cases of post-ERCP pancreatitis are     mild, but may be severe and lead to prolonged hospitalization a few patients. The occurrence     of this complication is unpredictable. There have been a number of attempts to prevent this     complication. These include giving certain drugs before ERCP e.g. octreotide, somatostatin,     steroids, etc. However, these have not been successful. Recently, a study showed that     application of glyceryl trinitrate patch on the skin before ERCP might reduce the incidence     of post ERCP-pancreatitis. Another study showed that per rectal administration of diclofenac     tablet after the ERCP procedure also reduced occurrence of post ERCP pancreatitis. Other     experimental studies have shown that certain anti-inflammatory drugs like cox-2 inhibitors     may also be effective.      The investigators want to study whether transdermal patch of glyceryl trinitrate or     administration of injectable cox-2 inhibitor Valdecoxib (pro-drug Parecoxib) can prevent     post-ERCP pancreatitis in our patients who undergo an ERCP.   "
196343|NCT00419562|"     Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part     of the body which helps fight infections) mistakenly attacks and destroys the cells that     produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's     ability to produce insulin decreases. There is evidence suggesting that repeated oral     administration of an autoantigen (the same protein that the immune system is reacting to) may     introduce a protective immunity and cause the immune system to stop its attack. An earlier,     large scale study was done to see if oral insulin could delay or prevent the development of     Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results     showed that for the entire study population, oral insulin did not delay or prevent Type 1     diabetes. However, an analysis that was done after the conclusion of the trial suggested a     potential beneficial effect in a subgroup of participants. The participants who seemed to     benefit from oral insulin had higher levels of insulin autoantibodies which are directed     against insulin itself ( called mIAA).      The Type 1 Diabetes TrialNet study group will further explore the potential role of oral     insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also     include a secondary group of individuals at different levels of risk than those in the     primary cohort to gather information for future studies.   "
198184|NCT00434343|"     The purpose of this study is to determine if a randomized trial of physical therapy for     pelvic pain is feasible.   "
196344|NCT00419575|"     The aim of this observational study is to evaluate an FDA approved immune system monitoring     assay (Immunknow, Cylex Inc. Columbia, MD) in renal transplant recipients using standard     immunosuppression and prophylaxis protocols from the time of transplantation through a twelve     month follow-up period. The primary endpoint will be the incidence of acute rejection and     infection and any correlation of these events to an assay that may be a measure of recipient     immune response. Secondary endpoints will include evaluation of renal function, patient and     graft survival, incidence of post-transplantation lymphoproliferative disorder and duration     and extent of lymphocyte depletion.   "
196345|NCT00419588|"     The purpose of this study is to evaluate the growth of the lung and how easily gas can be     taken up by the lung in healthy infants born at full term without any breathing problems and     infants born prematurely.   "
196346|NCT00419601|"     It shall be investigated whether ventilated neonates and infants with a remifentanyl based     analgesia and sedation can be extubated faster after discontinuation of the opioid infusion     compared to neonates and infants with a fentanyl based analgesia and sedation.   "
196347|NCT00419614|"     Chart review evaluating outcome of patients in whom following resection of a tumor involving     the head of the pancreas no anastomosis of the pancreatic stump was done to the     gastrointestinal tract.   "
196348|NCT00419627|"     The purpose of this study is to evaluate the presence of proteins in solid tumors which may     lead to an immune response   "
196349|NCT00419640|"     This is a randomized, parallel, single-blinded multi-center study. The objective is to     compare the long term clinical outcomes among the site of atrial pacing and to compare the     long term effect of the atrial fibrillation (AF) Suppression algorithm.   "
196350|NCT00419653|"     The study aims to investigate the modulation of regional brain activation in schizophrenic     patients by psychopharmacological treatment with either haloperidol, amisulpride or     olanzapine. The study will be performed with functional magnetic resonance imaging (fMRI) and     diffusion tensor imaging (DTI).   "
196351|NCT00419666|"     This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the     adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied     twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous     areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will     be collected during the first 3 weeks of the study; safety and efficacy data will be     collected for the 8 weeks of the treatment.   "
196370|NCT00419913|"     Our long term goal is to elucidate the role of DHEA on follicular dynamics in the human ovary     and to better understand the interaction of DHEA supplementation with other treatments for     ovulation induction, especially among older reproductive age women.      The specific hypothesis behind the proposed research is that DHEA is a regulator of     follicular dynamics acting in the early pre-gonadotropin dependent stage of initial     primordial follicle recruitment and growth.   "
196352|NCT00419679|"     Study FT3.6k-2006 is a single centre (the Mater Hospital, Sydney), blinded trial of a     diagnostic test for breast cancer, with outcomes compared to the gold standard of screening     mammogram followed by biopsy where required. This study aims to perform X-ray diffraction     analysis of coded hair samples from women with a documented breast health status, to validate     the findings of James et al (Nature 398: 33-4, 1999; Int J Cancer 114: 969-72, 2005) who     showed that the presence of breast cancer could be detected using synchrotron-derived x-ray     diffraction of human hair (scalp or pubic). The aim is also to characterise the sensitivity     and specificity of the hair test in detecting breast cancer in a screening setting, and to     determine the significance of a positive hair test and a negative mammogram.   "
196353|NCT00419692|"     This study in RLS patients is designed to assess the affect food has on the absorption,     distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted     state and other patients following a high-fat breakfast), and to assess the difference in     absorption, distribution, metabolism and excretion of ropinirole if patients are given two     3mg ropinirole tablets versus one 6mg tablet.   "
196354|NCT00419705|"     The purpose of this pivotal study is to demonstrate safety and effectiveness of the     NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects     diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for     each Subject within 24 hours of stroke onset.   "
196355|NCT00419718|"     The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of     exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with     type 1 diabetes.   "
196356|NCT00419731|"     The purpose of this study is to compare the effects of bupropion + placebo to bupropion +     naltrexone as treatments to help smokers quit.   "
196357|NCT00419744|"     The purpose of this study is to determine if SYMBICORT® delivered via a pressurized     metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.   "
196358|NCT00419757|"     The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a     medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.   "
196359|NCT00419770|"     The purpose of this study is to determine if the addition of the medication, deferasirox, to     standard antifungal therapy for the infection, mucormycosis, is safe and effective   "
196360|NCT00419783|"     The purpose of this study is to evaluate the effect of two doses of bilastine (20 and 100 mg)     compared to bilastine 20 mg administered with ketoconazole 400 mg, moxifloxacin 400 mg, and     placebo. Subjects will receive each of the five study treatments in a crossover fashion     administered once daily for 4 days.   "
196361|NCT00419796|"     This randomized study will compare the effect of lumiracoxib, ibuprofen and placebo on     24-hour blood pressure profile and on urinary excretions of eicosanoids in controlled     hypertensive patients who have osteoarthritis.   "
196362|NCT00419809|"     SB-681323 is a p38 MAP-kinase inhibitor that has potential uses in inflammatory conditions     such as RA. Previous p38 MAP-kinase inhibitors have been hindered in development by liver     toxicity. Methotrexate (common treatment for RA patients) also has potential liver toxicity.     This study was an enabling study to determine the safety of co-administration of the two     compounds with respect to liver function   "
196363|NCT00419822|"     This study is for the woman who will have axillary (armpit) surgery as part of their breast     cancer treatment. The purpose of this project is to evaluate if acupuncture is helpful to     control pain and improve range of motion (arm movement). Another goal is to find out if women     have an improvement in their quality of life. This study is being done in collaboration with     the Oregon College of Oriental Medicine (OCOM).   "
196364|NCT00419835|"     Chronic kidney disease (CKD)has become a significant health problem worldwide. Strategies to     decrease the rate of progression of this disease and reduce the number of patients needing     dialysis or renal transplantation are urgently needed. In this study we wish to compare the     effect of dual blockade of renin-angiotensin system (ACE inhibitors plus angiotensin II     receptor blocker) compared to the effect of ACE inhibitor monotherapy in patients with     diabetic chronic nephropathy.   "
196365|NCT00419848|"     a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin     in the management of moderate acne vulgaris   "
196366|NCT00419861|"     Influenza vaccination is recommended for all persons age 65 and older. Vaccines that are     designed and tested in young healthy adults are often not as effective when used in the     elderly. This study will be a one year pilot study to see if it would be practical to conduct     a larger study at several other hospitals in the future. Study participants will include 350     men and women greater than or equal to age 50 that are hospitalized at Vanderbilt University     or Baptist Community Hospital with acute respiratory symptoms. Study procedures will include     questions, one nasal swab, one throat swab, and chart reviews after the patient has been     released from the hospital. The nasal and throat swabs will be tested for influenza A and B     viruses.   "
196367|NCT00419874|"     The main goal of the present study is to challenge the hypothesis that blood- brain barrier     disruption following brain injury increases the risk for long-term disability, development of     brain dysfunction, epileptic seizures and neuroanatomical alterations.   "
196368|NCT00419887|"     The purpose of this study is to assess the safety, tolerability, effect of vildagliptin and     how the body changes the blood level of vildagliptin of single and multiple oral doses of     vildagliptin in healthy Chinese volunteers.   "
196369|NCT00419900|"     Using synchrotron X-ray diffraction, it has been reported that a hair from an individual with     breast cancer exhibits a difference in its molecular structure compared to that of an     individual without breast cancer. This difference is visible in the X-ray diffraction pattern     as a ring superimposed on the pattern for normal hair.      The hypothesis of this study is that synchrotron x-ray diffraction can be used to     differentiate hairs from women with medically diagnosed breast cancer from women not known to     have the disease.      To test this hypothesis, hair from 2000 women attending radiology clinics for mammography     will be collected, analysed by x-ray diffraction and then analysed using Fermiscan     proprietary image analysis software. The mammogram status of the subjects will be blinded     from the diffraction analysts. Results will then be compared with mammography results to     allow a direct comparison between the Fermiscan test and mammography in terms of specificity     and sensitivity.   "
196371|NCT00419926|"     The purpose of this study is to determine if an initial intensified enteric-coated     mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post     renal transplantation provides improved efficacy, with a similar safety profile, compared to     a standard regimen of Myfortic.   "
196372|NCT00419939|"     The aim of the study is to develop a research-based pedagogic model to improve the     interaction between the patient`s motivation, influence and learning.The hypothesis is:      A neuro-rehabilitation effort in patients with severe traumatic brain injury based on a     didactic model for improvement of motivation, involvement and re-learning of daily life     competences will        -  improve the patients experience of meaningful learning and influence        -  provide staff with a tool which contributes to the experience to work in a targeted way          concerning motivation, patient influence and re-learning daily life competencies      The aim of the study is to develop a research-based didactic model to improve the interaction     between the patient`s motivation, influence and learning.   "
196373|NCT00419952|"     The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a     medication approved by the Food and Drug Administration, FDA) in the African American     population.   "
196374|NCT00419965|"     The primary objective of this study is to determine the utility of GRK2 to differentiate     between normal patients and patient groups that differ by the presence/absence of HF     symptoms, systolic or diastolic left ventricular dysfunction, and risk factors; and to     evaluate if a new assay provides similar values as traditional methods for measuring GRK2     levels.   "
196375|NCT00419978|"     This study is for the patient with colon cancer, who is going to have colon cancer surgery.     The purpose of this research study is to examine a specific lymph node, called the sentinel     node. Lymph nodes are located throughout your body and cancer may spread by means of those     lymph nodes. The sentinel node is the one located closest to your tumor. This study will find     out if examining the sentinel node can help to predict disease progression. Since the value     of this exam is unknown, taking part in this study will not change your clinical care.   "
196376|NCT00419991|"     Tigecycline is being developed as an agent that overcomes tetracycline-resistance mechanisms     and provides activity against emerging multi-drug resistant pathogens. The purpose of this     protocol is to determine the linkage between time related clinical measures of infection     response and time to bacterial eradication in patients with intravascular catheter infections     caused by Staphylococcus epidermidis and other coagulase negative staphylococci.   "
196377|NCT00420004|"     This is a study to assess the safety and effectiveness of LY2216684 compared to placebo in     treating adults with major depressive disorder.   "
196378|NCT00420017|"     The investigators hypothesize that the medication amiodarone decreases the incidence of     atrial fibrillation (AF) following esophagectomy surgery. Their specific aims are to:      Determine the effectiveness of amiodarone for the prevention of AF following esophagectomy     surgery; Determine the influence of the prevention of AF following esophagectomy surgery on     post-surgical duration of stay in the Intensive Care Unit ICU)and duration of post-surgical     hospital stay; and Determine the safety of amiodarone for the prevention of AF following     esophagectomy surgery.   "
196379|NCT00420030|"     Outcome of patients with myocardial infarction complicated with cardiogenic shock is very     poor. Although early mechanical revascularization has been demonstrated superior to     conservative medical treatment, mortality range remains about 45-60%. Some medical registries     have showed further therapeutic benefit by administration of glycoprotein (GP) IIb/IIIa     inhibitors during PCI in patients with cardiogenic shock. However, there is no randomized     study that supports this therapeutic strategy in these high risk patients.      Hypothesis:      GP IIb/IIIa inhibitors improve angiographic (TIMI-flow), echocardiographic (LV function) and     clinical (combined end-point) outcomes in patients with myocardial infarction complicated     with cardiogenic shock.      Study design:      Open pseudorandomized multicenter, phase IV clinical trial.      Anticipated findings:      The investigators anticipate to document better angiographic, echocardiographic and clinical     outcome after upfront abciximab administration in comparison to standard periprocedural     therapy in patients undergoing PCI for cardiogenic shock. This would be the first randomized     clinical trial that could support this therapeutic strategy.   "
196380|NCT00420043|"     This study will evaluate the effect of food on the relative bioavailability of a single dose     of imatinib given as a 800 mg modified release tablet, compared to twice-daily doses of 400     mg film-coated tablets. There will be a 8 day wash out phase between treatments and a 1 week     safety period at the end of the study. Each participant will receive all four treatments.   "
196381|NCT00420056|"     This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is     also known as a PET scan. This study will assess the safety of using PD-0332991 in patients     with mantle cell lymphoma.   "
196382|NCT00420069|"     The MRTX portable lightweight respirator (MRTX) provides noninvasive respiratory support     using biphasic extrathoracic ventilation via a cuirass fitted around the patient's chest.The     aim of the study is to evaluate the efficacy of the MRTX during dental treatment under deep     sedation in comparison with the conventional treatment where children are only under monitor     and only intervention is done when required.Twenty healthy children (ASA1) will wear the     cuirass. PO2 saturation and ETCO2 will be recorded as a baseline. Half of the children will     be ventilated (with similar values to those of physiologic respiration) and the other half     will notThe study is blind, since the anesthesiologist and the dentist would not know if the     cuirass of the child is connected to the MRTX or not:      Group 1- 10 children with the cuirass will be connected to the MRTX and artificially     ventilated at pressures of (-12/+5) at a rate of 20 per minute, and PO2 and ETCO2 will be     recorded every 5 minutes.      Group 2- 10 children with the cuirass will not be connected to the MRTX, but the machine will     work at the same condition. Same records of PO2 and ETCO2 will be registered.   "
196383|NCT00420082|"     This is a randomized, double blind, active and placebo controlled, 4 way crossover study in     patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20     mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.   "
196384|NCT00420095|"     The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with     type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin     30/70.   "
196385|NCT00420108|"     The objective of this study is to evaluate whether the heart rate variability, daily heart     rate, and/or intrathoracic impedance recorded by implantable cardiac devices can be used in     conjunction with other traditional clinical practice methods to determine if heart failure     patients are ready for hospital discharge.   "
196386|NCT00420121|"     Cutaneous lupus erythematosus (CLE) is a disease with a wide spectrum of clinical     manifestations and a variable prognosis. The aim of the study is to create a standardized     evaluation of the different subtypes of this disease in order to receive an overview of the     spectrum of clinical and laboratory features as well as the therapeutic strategies for     patients with CLE.   "
196387|NCT00420134|"     The methods for separation of mesenchymal stem cell were established in 2001. These cells can     differentiate to osteocytes, hepatocytes, chondrocytes, myocytes and etc,. In this study the     investigators try to separate mesenchymal stem cell from end stage liver disease, then these     cells will be differentiated to progenitor of hepatocytes, finally , the investigators     injected these cells into portal vein under ultrasound guide. The investigators determine the     effects of injected cells in reestablishment of liver function.   "
196388|NCT00420147|"     The five-year goal of this project is to investigate the effect of in-shoe wedged orthoses on     lower extremity function in patients with knee osteoarthritis. In general, our aims address     the long-term effects of orthoses. The investigators hypothesize that subjects who use the     lateral wedged in shoe orthosis will result in altered gait mechanics that reflect a     reduction in the frontal plane knee joint moment compared to subjects who use a neutral in     shoe orthosis.   "
196389|NCT00420160|"     This study compares the effects of a standard smoking cessation treatment, including one-time     brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise     program versus the same standard smoking cessation treatment plus equivalent contact control     among 60 healthy women. We hypothesize that participants in the smoking cessation plus     moderate intensity exercise condition will be more likely to quit smoking than participants     in the smoking cessation treament plus contact control condition.   "
196390|NCT00420173|"     Cutaneous lupus erythematosus (CLE) is a disease with a wide spectrum of clinical     manifestations and a variable prognosis. The aim of this study is to create a standardized     evaluation of the different subtypes of this disease in order to receive an overview of the     spectrum of clinical and laboratory features as well as the therapeutic strategies for     patients with CLE.   "
196391|NCT00420186|"     The purpose of this clinical research is to assess the safety and tolerability of BMS-690514     when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be     administered on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given     in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An     additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with     Paclitaxel and carboplatin   "
196408|NCT00420420|"     The purpose of this study is to test the efficacy and safety of an investigational medication     for improving symptoms of Alzheimer's Disease. Subjects will receive either active medication     or placebo for 28 days. Tests of memory, concentration will be included. Safety will be     monitored using routine clinical and laboratory tests.   "
196392|NCT00420199|"     The only trial in participants who are methotrexate-inadequate responders and have active     Rheumatoid Arthritis, in which gadolinium-enhanced Magnetic Resonance Imaging; Bone Mineral     Density; and biochemical markers of bone, cartilage, and synovial tissue metabolism are used     to evaluate early effects (4 months) of Abatacept on inflammation/structural damage. Study     will provide valuable mechanism-of-action information on how Abatacept exerts its effects     (including on bone) through new techniques.   "
196393|NCT00420212|"     To determine if treatment with BG00012 can decrease the number of MS relapses during a     certain time period. To determine if, over time, BG00012 treatment can decrease the number of     certain types of brain lesions commonly seen in MS patients and slow down the time it takes     for the disease to get worse.      The purpose of this study is also to determine the safety of BG00012 and how well it is     tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used     to assess MS.   "
196394|NCT00420225|"     The purpose of this study is to determine whether reenforcement with polypropylen mesh     compared with traditional anterior colporrhaphy for anterior vaginal wall prolapse results in     fewer recurrences.   "
196395|NCT00420238|"     Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe     and advanced ankylosing spondylitis.   "
196396|NCT00420251|"     Growth retardation is well known in patients with severe forms of juvenile idiopathic     arthritis. Especially those who were under additional treatment with glucocorticoids for high     disease activity. The hypothesis is, that treatment with growth hormone can, at leat in part,     overcome growth hormone resistance state and increase final height. In a controlled study we     follow patients with juvenile idiopathic arthritis with and without growth hormone treatment     until final height. Additionally, we are interested in bone density development in those     treated with growth hormone.   "
196397|NCT00420264|"     Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can     be tolerated in the office setting without the use of intravenous medication.   "
196398|NCT00420277|"     The purpose of this study is to determine whether Hemospan is superior to Voluven for     treatment of hypotensive episodes during the perioperative period (from induction of spinal     anesthesia until 6 hours after skin closure), and for reducing the incidence of operative and     postoperative complications including organ dysfunction and failure until follow-up at one     month following surgery. An independent Data Safety Monitoring Board (DSMB) will periodically     evaluate the safety data collected during this trial   "
196415|NCT00420511|"     Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive     deterioration in the function of the pancreatic beta-cells, which are the cells that produce     and secrete insulin (the hormone primarily responsible for the handling of glucose in the     body). The investigators propose a double-blind, randomized controlled pilot study comparing     the effect of sitagliptin (a novel anti-diabetic drug with beta-cell protective potential)     versus placebo, on the preservation of beta-cell function over one year in patients with T2DM     on metformin, the first-line agent for the treatment of T2DM (ie. the study groups will be     (i) sitagliptin and metformin versus (ii) placebo and metformin). This study may demonstrate     an important beta-cell protective capacity of sitagliptin.      Hypothesis: In patients with T2DM on metformin, treatment with the DPP-IV inhibitor     sitagliptin will preserve pancreatic beta-cell function.   "
196399|NCT00420290|"     Chronic hemodialysis (CHD) patients display multiple metabolic abnormalities related to     advanced uremia. Despite vigorous attempts to prevent these abnormalities and their     consequences, most CHD patients suffer from a unique form of nutritional derangement, which     can be termed as uremic wasting. Several studies have demonstrated that the presence of     uremic wasting, especially the degree of loss of muscle mass, sharply increases mortality and     hospitalization rate in CHD patients.      Several factors have been thought to be associated with uremic wasting, including hormonal     derangement, anorexia, physical inactivity, and concurrent illnesses. Chronic inflammation,     also highly prevalent in these patients, causes muscle catabolism in animal models and     certain clinical conditions. Epidemiological studies show an association between chronic     inflammation and uremic wasting in hemodialysis patients indicating a possible causal     relationship.      The cause for the activated inflammatory state in CHD patients is believed to be     multi-factorial. Nevertheless, it is certainly important for the host to limit its biological     activity by eliciting a stronger anti-inflammatory response, for example through the     production of naturally occurring receptor antagonist. Interleukin 1 beta, one of the major     pro-inflammatory cytokines has been shown to be associated with protein catabolism in several     chronic disease states, including advanced uremia. A balance between interleukin 1 beta     (agonist) and its naturally occurring receptor antagonist IL-1ra may play a pivotal role in     controlling the inflammatory response and its consequences in this population.      The overall goal of this particular grant application is to examine the short-term effects of     the administration of the recombinant form of IL-1ra on 1) chronic inflammatory state and 2)     protein homeostasis in chronically inflamed CHD patients.      We have updated our protocol to perform an interim analysis. The interim analysis will be     performed after half of the planned study sample has been enrolled (14 subjects; 7 in each     arm). The interim analysis has been approved by the Data Safety Monitoring Board.   "
196400|NCT00420303|"     To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and     refractory heel enthesitis.   "
196401|NCT00420316|"     To assess the long-term efficacy and safety of the subjects during the third year after     priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the     primary vaccination study (102247). The Rotarix vaccine was administered in the primary     vaccination study. There was no vaccine/intervention in this long-term efficacy study.   "
196402|NCT00420342|"     The main purpose of this study is to compare the effects of treatment of two different     formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with     prehypertension.   "
196403|NCT00420355|"     The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and     atazanavir when lopinavir/ritonavir and atazanavir are used in combination.   "
196404|NCT00420368|"     This study tests the hypothesis that moderately underweight but not severely wasted     6-17-month old infants receiving fortified spread or maize-soy flour as a food supplement for     12 weeks grow better during the supplementation than infants who do not get any food     supplement.   "
196405|NCT00420381|"     The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in     patients with recurrent or persistent ovarian cancer.   "
196406|NCT00420394|"     Rationale: Adjuvant chemoradiation considered as standard of care after curative surgery for     adenocarcinoma of stomach and gastroesophageal cancer. Preoperative chemotherapy in the in     locally advanced gastric cancer results in significant tumoral downstaging with improved rate     of curative resections.      Purpose: To evaluate feasibility and safety of combination of preoperative chemotherapy and     postoperative chemoradiation for locally advanced adenocarcinoma of stomach and     gastroesophageal cancer   "
196409|NCT00420433|"     Primary Objectives:        -  To estimate and compare the sensitivity and specificity of computed tomography (CT),          plain radiography (XR), and skeletal scintigraphy (SS) with each other for the          assessment of response of bone metastasis in patients with breast cancer.        -  To estimate and compare the sensitivity and specificity of M. D. Anderson (MDACC) bone          metastasis criteria with that of current criteria (UICC, WHO) in breast cancer patients          for the assessment of the behavior of osseous metastasis in breast cancer patients.      Secondary Objective:        -  To evaluate the progression free survival (PFS) and overall survival (OS) of each          response group (CR, PR, SD, PD) assessed by imaging and response criteria.   "
196410|NCT00420446|"     The purpose of the project is to elucidate the effect on blood pressure by daily intake of     dairy products. Previous studies have demonstrated a beneficial effect on blood pressure.      In total 90 subjects will be enrolled. For eight weeks, the participants will ingest one of     two different dairy produces. Before, during and after the study period, the blood pressure     is measured.   "
196411|NCT00420459|"     The purpose of this study is to determine the effectiveness and tolerability of aripiprazole     in the treatment of children and adolescents with Fragile X Syndrome.   "
196412|NCT00420472|"     This study will assess the safety, efficacy and effect on quality of life of switching kidney     transplant patients from reduced dose EC-MPS treatment due to gastrointestinal problems to a     higher than the equimolar dose of CellCept. Patients will be switched, initially, from EC-MPS     (<1440g/day) to an equimolar dose of CellCept, and at the next visit (day 10 +/- 5) the     CellCept dose will be increased by 250mg/day, and the daily dose will be split into 3-4     doses. The anticipated time on study treatment is <3 months, and the target sample size is     <100 individuals.   "
196413|NCT00420485|"     This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan     administered orally in patients with advanced solid tumors   "
196414|NCT00420498|"     The purpose of this study is to examine the effects of atomoxetine (Strattera™) on prefrontal     cognitive functioning in persons with schizophrenia. Secondarily, the effects of atomoxetine     on positive and negative symptoms and on cigarette smoking consumption in persons with     schizophrenia will be examined.   "
196416|NCT00420524|"     This phase I study will determine the pharmacokinetic profile of patupilone in patients with     mild or moderately impaired hepatic function within 2 cycles of treatment. The study     population for this trial consists of patients with a documented advanced solid tumor.     Patients will be stratified into 3 groups: those with normal liver function, and those with     mild or moderate liver dysfunction.   "
196840|NCT00417391|"     The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of     1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's     disease.   "
196417|NCT00420537|"     The purpose of this study is to verify if the combination of Everolimus with a very low dose     of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose     of cyclosporine in reducing the progression of kidney dysfunction in patients with heart     transplantation.   "
196418|NCT00420550|"     Interstitial cystitis (IC) affects more than one million women in the United States. It has     been thought that IC patients who have been unable to obtain adequate relief from medical     remedies would value a psychotherapeutic intervention that could diminish some of their pain.      There are currently no studies using biomarkers with the use of a relaxation technique called     guided imagery in IC patients. Many guided imagery intervention studies in areas such as     cancer, post-operative pain, and arthritis reported that guided imagery resulted in     improvements in the psychological or physiological outcomes examined. If this is also true in     IC patients, this intervention may prevent the use of unnecessary medications and procedures     that are currently being used.   "
196419|NCT00420563|"     The scope of the trial is to assess the free progression rate at 2 months for each group of     patients.   "
196420|NCT00420576|"     Main purpose of the study is to look for an optimal dose for the treatment of menopausal     symptoms with the Chinese Herbal Medicines containing Dang Gui and Huang Qi.   "
196421|NCT00420589|"     To compare the effects of taranabant versus placebo on weight regain and weight maintenance     after low calorie diet-induced weight loss in obese patients.   "
196422|NCT00420602|"     We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids     such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3     patients. Therefore, the purpose of this study is to follow STGD3 patients as they supplement     their diets with DHA/EPA.   "
196423|NCT00420615|"     The purpose of this study is to evaluate the potential inhibitory effects of patupilone on     metabolism using midazolam and omeprazole as the respective probe drugs.   "
196424|NCT00420628|"     A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in     children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)   "
196425|NCT00420641|"     To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the     treatment of outpatients subjects with major depressive disorder to exhibit decreased     pleasure, interest and energy.   "
196426|NCT00420654|"     Growth hormone treatment is used in girls with Turner syndrome to increase final height. The     aim of this study is to evaluate the effect of growth hormone treatment on body composition     and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass     will decrease and lean body mass will increase. There is only very limited documentation of     the effect on the heart in this study population.   "
196427|NCT00420667|"     Because the impairment of platelet function may cause excess peri-operative bleeding,     pre-operative aspirin discontinuation and heparin bridging are common at cardiac surgery. We     aimed to evaluate the impact of a low-molecular-weight-heparin (LMWH), enoxaparin, and     unfractionated heparin (UFH) on coagulation parameters and peri-operative bleeding in     patients undergoing elective coronary artery bypass grafting (CABG) surgery after aspirin     discontinuation.      The specific hypothesis of this study was that a 12 h interval is sufficient not to cause     excess peri-operative bleeding, and is therefore an optimal compromise between antithrombotic     efficacy and haemorrhagic safety.   "
196428|NCT00420680|"     The purpose of this study is to evaluate the safety of 2.0 mg/kg and 4.0 mg/kg sugammadex     given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium in cardiac     patients   "
196429|NCT00420693|"     The objective of this randomized and controlled study is to compare the sedation with     sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate     peripheral inserted central catheter insertion in a pediatric and neonatal intensive care.     Main measurements concern success or failure of insertion, duration of procedure, movements     of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate,     respiratory frequency and oxygen saturation.   "
196430|NCT00420706|"     To evaluate whether the tolerability of SCA-136 is improved by dosing with food or by     increasing dose amounts in a step-wise fashion.   "
196431|NCT00420719|"     The overall goal of this research is to delay the respiratory decline of patients with     Amyotrophic Lateral Sclerosis (ALS) thereby increasing their lifespan by conditioning the     diaphragm with laparoscopically placed electrodes.      This device currently holds an Investigational Device Exemption No. G040142 in the United     States and is currently undergoing clinical trials at University Hospitals (Cleveland), Johns     Hopkins, Mayo Clinic Jacksonville, California Pacific Medical Center (CPMC), Henry Ford     Health System, The Methodist Hospital, and Stanford University.   "
196432|NCT00420732|"     To determine the response rate of the administration of HyperAcute-Lung Cancer Vaccine for     subjects with stage IIIB or stage IV non-small cell lung cancer who have been treated with     first line platinum-doublet therapy and have responded or are considered to have stable     disease.   "
196433|NCT00420745|"     This study is planned to evaluate the safety (in terms of occurrence of any serious adverse     events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to     develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants     aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and     in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study     will be performed in four European countries (France, Poland, Spain, and Portugal). The     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
196434|NCT00420758|"     This study tests the hypothesis that moderately underweight but not severely wasted     6-17-month old infants receiving fortified spread or maize-spy flour as a food supplement for     12 weeks grow better during the supplementation than infants who do not get any food     supplement.   "
196467|NCT00421200|"     The purpose of this study is to determine whether Hemospan is superior to Voluven for     preventing hypotensive episodes during the perioperative period (from induction of spinal     anesthesia until 6 hours after skin closure), and for reducing the incidence of operative and     postoperative complications including organ dysfunction and failure until follow-up at one     month following surgery. An independent Data Safety Monitoring Board (DSMB) will periodically     evaluate the safety data collected during this trial.   "
196435|NCT00420771|"     The aim of this project is to study the use of gabapentin in reducing benzodiazepine abuse in     methadone maintenance patients. A second aim is to study the effects of gabapentin on     craving, mood, anxiety, and sleep disturbance in methadone maintenance patients abusing     benzodiazepines. The proposed protocol is a randomized, double-blind, placebo-controlled     pilot outpatient trial of gabapentin in the treatment of benzodiazepine abuse in methadone     maintenance patients. All subjects will receive weekly manual-guided psychotherapy directed     at achieving abstinence and improving current functioning. The primary outcome measure,     benzodiazepine use, will be assessed weekly by a combination of self-report (time line     follow-back method) and urine toxicology. Associated psychological symptoms of craving, mood,     anxiety, and sleep disturbance, will be assessed by a combination of clinician and self-rated     instruments.      The investigators hypothesize that individuals receiving methadone maintenance treatment who     are abusing (nonprescribed use) benzodiazepines have difficulty in reducing or discontinuing     benzodiazepine use because of the significant anxiety, mood, and sleep disturbance symptoms     that accompany reduction in use. Gabapentin, an anticonvulsant which has anxiolytic and     sedating properties, may alleviate the symptoms associated with a reduction in benzodiazepine     abuse and make the achievement of abstinence more likely when administered in the setting of     an active psychotherapy condition.   "
196436|NCT00420784|"     The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an     investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a     (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1     hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment     of interferon therapy.   "
196437|NCT00420797|"     The aim of the study is to test the hypothesis that topical application of phenylephrine     improves faecal continence and quality of life in subjects with passive faecal incontinence     after ileo-anal pouch construction.   "
196438|NCT00420810|"     The purpose of this study is determine whether this drug will improve your insomnia in terms     of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will     be compared against placebo in order to determine if there's a difference.   "
196439|NCT00420823|"     The purpose of this study is to determine whether Taurine 4g is effective with antipsychotic     medication in the treatment of First Episode Psychosis.Taurine may have an effect on     cognition and symptoms. We are examining changes in symptoms and cognition over a 3 month     period.   "
196440|NCT00420836|"     This study assesses the aerosol delivery characteristics (measured by nebulization time,     serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered     for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet     Nebulizer (with compressor) in subjects with cystic fibrosis.   "
196441|NCT00420849|"     This is a multi-centre, single-arm treatment study combining lenalidomide plus high dose     dexamethasone.      Subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone     in 4 week cycles. Subjects will be seen every 2 weeks for the first 3 cycles of therapy and     then every 4 weeks after the third cycle until disease progression is documented, study drug     is discontinued for any reason or lenalidomide becomes commercially available for this     indication. Assessments of safety and quality of life are performed during the study.   "
196491|NCT00411814|"     This is a two part study. Part I is designed to test single doses of GSK678586A in healthy     volunteers. Part II is designed to test repeat doses (two doses) of GSK679586A in patients     with mild asthma. Both parts are designed to investigate the safety, tolerability and the way     the body absorbs GSK679586A when given by intravenous infusion (through a vein in your arm).   "
196442|NCT00420862|"     High survival rates have been reported for screen-detected Stage I lung cancer patients, but     there are concerns about the potential biases of uncontrolled studies. DANTE is a prospective     randomized controlled trial exploring the effects of screening with LDCT on     lung-cancer-specific mortality, and on the prevalence and incidence rates of lung cancer,     stage distribution and resectability rates in a selected high-risk population. The prevalence     of a set of biomarkers in sputum and blood samples is also being determined.   "
196443|NCT00420875|"     To determine the magnitude of improvement for pain and function symptoms over a two year     period after enrollment into the registry study in patients presenting with chronic heel pain     and receiving standard of care treatment. Standard of care will include traditional     conservative care measures, ESWT, radiofrequency-based plasma microdebridement, scalpel     debridement and/or surgical release.   "
196444|NCT00420888|"     The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes     tumor cells and one that triggers an attack on the tumor cells by activating some white blood     cells belonging to the body's normal immune system. This results in an accumulation of white     blood cells in the cancer that can fight the cancer. This study will compare the safety and     effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox     when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal     cell carcinoma (RCC).   "
196445|NCT00420901|"     chronic PDE5-Inhibition improves endothelial function in diabetics   "
196446|NCT00420914|"     To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a     standard dose platelet transfusion strategy.   "
196447|NCT00420927|"     This study compared the safety and efficacy of combination therapy with adalimumab plus     methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early     rheumatoid arthritis (RA).   "
196466|NCT00421187|"     Administration of a single high dose (10 mg/kg) of AmBisome® no later than 72 hours after     ARNF onset followed by two 5 mg/kg doses on days 2 and 5 may provide sustained tissue levels     of amphotericin B that are as mycologically effective as those provided after administering     the standard daily dose of 3 mg/kg/day. The new dosing regimen is anticipated to be equally     clinically effective compared with the standard AmBisome® regimen when given for the duration     of neutropenic fever in patients with ARNF. In addition, the degree and incidence of     nephrotoxicity are predicted to be lower with the 3 sequential dose regimen compared to daily     dosing with 3 mg/kg because of the lower cumulative dosage (20 mg/kg versus 42 mg/kg,     respectively), which is 1 contributing factor for the development of acute renal failure.     Furthermore, the lower cumulative dose may be a cost-effective strategy for the treatment of     patients with ARNF.   "
196468|NCT00421213|"     The study of safety of a new organic arsenic compound in the treatment of hematological     malignancies.   "
196469|NCT00421226|"     This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of     ACZ885 administered via intravenous infusion and subcutaneous injection in healthy Japanese     male volunteers.   "
196448|NCT00420940|"     This study will examine whether whole-body vibration slows down bone loss in healthy     postmenopausal women with osteopenia. Whole-body vibration is a promising novel therapy that     involves standing on a platform which produces extremely small and fast up-and-down     movements. Some but not all research studies have found that whole-body vibration slowed down     bone loss in postmenopausal women. One of the reasons why different studies found different     results may be because they used various speeds of vibration. This study looks at how     different speeds of whole-body vibration influence bone mineral density differently in     postmenopausal women who have osteopenia. Two hundred postmenopausal women will take part in     this 12-month study. Women will be randomly assigned into three groups (67 women per group)     and these groups will be compared. Group 1 will receive very fast whole-body vibration, Group     2 will receive fast whole-body vibration, and Group 3 will not receive whole-body vibration.     We will look at various bone mineral density and bone quality measurements, obtained with     three different types of technologies, at the beginning of the study and at 12 months of     follow-up. The hypothesis of this study is that the in comparison to Group 3 (no vibration),     Groups 1 and 2 will experience reduced bone loss over 12 months, and that the greatest     reduction in bone loss will be experienced by Group 1. The results of this study will help us     determine whether whole-body vibration at different speeds produces variable effects on bone,     hence explaining the inconsistency of the results obtained in previous studies.   "
196449|NCT00420953|"     Determine the relative bioavailability of PM101 I.V. and Cordarone I.V.   "
196450|NCT00420966|"     The purpose of this study is to determine the utilization patterns and compliance rates of     palivizumab, which is a monoclonal antibody therapy used to prevent respiratory syncytial     virus infection.   "
196451|NCT00420992|"     The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with     placebo for treating moderate to severe chronic pain over a 12 week period.   "
196452|NCT00421005|"     Statin therapy is a treatment with a proven positive impact on survival after heart     transplantation. However, it is unclear whether the beneficial effect of this class of drugs     depends solely on their LDL-lowering properties or on anti-inflammatory and immuno-modulatory     properties. Thus, this study was designed to compare safety and efficacy of two different     strategies: 1. high fixed statin dose vs. 2. low starting dose with LDL-driven doses     adjustments.   "
196453|NCT00421018|"     The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to     regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in     patients with allergic asthma   "
196454|NCT00421031|"     The purpose of this study is to assess the efficacy and safety of 4 doses of     desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of     moderate to severe vasomotor symptoms associated with menopause, as well as its influence on     sleep parameters and other health outcomes indicators.   "
196455|NCT00421044|"     Patients who participated in the core EPO2121 study and did not clinically progress may     participate in this extension protocol to further evaluate the safety, tolerability, and     efficacy of patupilone.   "
196649|NCT00425139|"     The purpose of this study is to determine the effects of playing the interactive video game,     Re-Mission, on patient outcomes, including adherence to medical treatment regimes, self-care     behaviors, quality of life, stress, communication, control, and knowledge.   "
196456|NCT00421057|"     Primary Objective:      -Determine if a specific exercise regimen (combined strength training/functional endurance)     reduces the level of fatigue among women with breast cancer while undergoing adjuvant or     neoadjuvant chemotherapy treatment as compared to a control group.      Secondary Objectives:        -  Determine if a specific exercise regimen (combined strength training/functional          endurance) increases the overall ability to perform daily physical activities (ADLs)          among women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy          treatment as compared to a control group.        -  Determine if a specific exercise regimen (combined strength training/ functional          endurance) increases mobility in women with breast cancer while undergoing adjuvant or          neoadjuvant chemotherapy treatment as compared to a control group.        -  Determine if a specific exercise regimen (combined strength training/functional          endurance) increases endurance in women with breast cancer while undergoing adjuvant or          neoadjuvant chemotherapy as compared to a control group.   "
196457|NCT00421070|"     The purpose of this study is to investigate whether relaxation massage therapy is effective     in reducing the levels of arousal and aggression on a young adult inpatient unit. It is     hypothesised that relaxation massage therapy will lead to a lower incidence of violence and     aggression on the ward via a reduction in the level of arousal and anxiety among inpatients.   "
196458|NCT00421083|"     This is a study of the efficacy and safety of on-demand dosing of tadalafil or placebo     administered for 12 weeks to men with erectile dysfunction caused by spinal cord injury.   "
196459|NCT00421096|"     The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin +     radiotherapy followed by an adjuvant chemotherapy   "
196460|NCT00421109|"     The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg     Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic     Idiopathic Urticaria.   "
196461|NCT00421122|"     This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD     patients as defined by GOLD treatment guidelines in order to obtain an approval for     indication of COPD from Chinese State Food and Drug Administration.   "
196462|NCT00421135|"     The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced cancer.   "
196463|NCT00421148|"     The purpose of this study is:        -  to explore the dose-response relation of sugammadex given as a reversal agent at          reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult subjects        -  to explore the pharmacokinetics of sugammadex in pediatric and adult subjects, and to          evaluate the safety of sugammadex in pediatric and adult subjects.   "
196464|NCT00421161|"     Olive oil and Omega 3 have many anti inflammatory effects that may be beneficial in the     inflammation and edema of chronic stasis dermatitis. The olive oil contains many mono     unsaturated fatty acids and anti oxidants that may add to the well being of a diseased skin     by improving cell membrane homeostasis.   "
196465|NCT00421174|"     The study is designed as a Phase III, multi-center randomized, double-blind,     placebo-controlled trial investigating the use of etanercept for the treatment of acute,     non-infectious pulmonary dysfunction (IPS) occurring after allogeneic hematopoietic cell     transplantation (HCT).   "
196471|NCT00421252|"     Patients who have stents placed in their coronary arteries require treatment with at least     two medications to prevent platelets from sticking to the stainless steel stent and forming a     blood clot that can result in a heart attack. The 2 anti-platelet medications used for most     patients with stents are aspirin and clopidogrel (Plavix). These are usually prescribed for     1-12 months (the length of time depends on the number and types of stents implanted).     Although the typical long-term dose of clopidogrel is 75 mg by mouth once daily, a larger     dose (known as a loading dose) is usually given at the start of treatment to help the     medication take effect more quickly.      Prior to January 2006, most patients at the Beth Israel Deaconess Medical Center (BIDMC) who     were undergoing PCI and who had not already been taking clopidogrel would receive a loading     dose of 300-600 mg of clopidogrel in the cardiac catheterization procedure room immediately     after the angioplasty and stenting portion of the procedure. However, several recent studies     suggest that administering clopidogrel 600 mg at least two hours prior to an angioplasty     procedure can reduce the rate of complications afterwards (especially reducing the chances of     detectable damage to the heart muscle).      The main purpose of this study is to see whether giving a loading dose of clopidogrel 600 mg     to outpatients scheduled to undergo cardiac catheterization with coronary angiography can     decrease the risk of procedure-related complications during the 14 days following the cardiac     catheterization compared to a strategy of giving clopidogrel 600 mg after the procedure only     to those who undergo angioplasty. We will focus our attention particularly on detecting     damage to heart muscle following angioplasty (which might be expected to improve with a     loading dose of clopidogrel before the procedure) and on bleeding and other groin     complications (which might worsen with clopidogrel loading before the procedure).      The drug clopidogrel has been approved by the Food and Drug Administration (FDA) for use in     patients with a recent or ongoing heart attack, narrowings in major blood vessels outside the     heart, or recent stroke with a loading dose of 300 mg followed by 75 mg once daily. It has     been used in several large studies with a loading dose of 600 mg without a significant     increase in major adverse effects. However, we do not yet know if it is useful or safe when     given as a loading dose of 600 mg before cardiac catheterization for outpatients with stable     symptoms and who are not thought to be in the midst of a heart attack.   "
196472|NCT00421265|"     In patients with prostate cancer with indolent features, disease progrssion may be very slow     and in many cases will never become clinically evident during the patient's lifetime. Active     surveillance is a continuous process of monitoring disease characteristcs aiming to avoid the     morbidity of active therapy in patients with stabe indolent parameters, while offering early     detection of disease activity in others who will need active therapy to control their     disease. We hypothesize that active surveillance will permit the avoidance of therapy related     morbidity in the majority of appropriate patients and will be associated with maintaining     their quality of life.   "
196473|NCT00421278|"     A study to test the effects of study drug (MK 0633) on patients with Atherosclerotic disease   "
196474|NCT00421291|"     A lack of public awareness about entitled health and social services may contribute to poor     delivery of services in developing countries. We sought to determine the impact of educating     villagers about entitled services.   "
196475|NCT00421304|"     The primary objective of this study is to describe the effect of a single dose of medication     compared to placebo in the upper respiratory tract in previously healthy children less than     or equal to 12 months of age who are hospitalized with lower respiratory tract illness.   "
196476|NCT00421317|"     The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic     ocular melanoma patients.   "
196477|NCT00421330|"     The purpose of this trial is to assess whether the new endovascular repair technique of the     abdominal aortic aneurysm (AAA) is an adequate substitute of the conventional AAA repair.   "
196478|NCT00421343|"     The purpose of this study is to develop and implement an evidence based protocol for the     secondary prevention of osteoporotic fractures and falls, and to determine how compliance     with this intervention improves muscle strength and functional status following a fracture.   "
196479|NCT00421356|"     The Ossur Prosthetic Power Knee claims to assist in helping people with transfemoral     amputation to walk up stairs and stand up from sitting. We expect to find that this product     has the ability to help unload the sound knee during these tasks. We plan to collect force     and motion data while people stand up from a chair. We will compare the data from people     using several types of prosthetic knees, including the power knee as well as from people who     are not amputees to see what the force and motion contributions are from the different knees     evaluated.   "
196480|NCT00421369|"     In this project we aim to further refine indications for the use of the thyroid hormone - T3     for patients suffering from depression. We aim to identify a sub-group of patients who are     more likely to respond to T3 and establish the time in the treatment course when T3 should be     added. The results of this project could have significant, direct clinical implications.   "
196481|NCT00421395|"     This will be an open label, multiple center, non-randomized, dose-escalation Phase I/II     trial, designed to evaluate the safety and effectiveness of a repeated, outpatient regimen     utilizing IMMU-hLL2 intact monoclonal antibody IgG labeled with different doses of 90Y for     the treatment of patients B-cell lymphoma (NHL).   "
196482|NCT00421408|"     Women and men consuming a low protein diet may be at risk for bone loss. The purpose of this     study is to determine whether a daily protein supplement will improve bone health among     healthy older adults.   "
196483|NCT00421421|"     The purpose of this study is to evaluate the efficacy and safety of dutasteride at reducing     relapse rates of Acute Urinary Retention (AUR), including reduction in surgical intervention     for benign prostatic hyperplasia (BPH), in patients who receive a 6 month treatment of     dutasteride (0.5mg once daily) following a single episode of AUR followed by successful Trial     Without Catheter compared with placebo.   "
196484|NCT00421434|"     The purpose of this study is to evaluate the safety and efficacy of     nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens     compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C     genotype 4. The study will also evaluate the effect of the studied treatment regimens on end     of treatment virologic response, ALT normalization and safety parameters.   "
196485|NCT00421447|"     The primary objective of this study is to determine if trabecular or cortical volumetric bone     mineral density (vBMD) change over time in postmenopausal breast cancer patients who are     prescribed Anastrozole, as measured by pQCT at the proximal and distal radius and tibia.   "
196486|NCT00411736|"     In patients with Cystic Fibrosis, recurrent airway infection caused by Pseudomonas aeruginosa     ultimately leads to chronic airway infection. The purpose of this study is to determine     whether supplementary low-dose azithromycin to standard inhaled colistin and oral     ciprofloxacin in the treatment of intermittent pseudomonas airway-infection can postpone the     next episode of intermittent pseudomonas airway-infection and prevent development of chronic     airway-infection.   "
196487|NCT00411749|"     The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent     females   "
196916|NCT00418379|"     A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR     sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen     rhinoconjunctivitis   "
196488|NCT00411762|"     The aim of this research project is to determine the amount of capecitabine (Xeloda) which     can be given safely with PHY906 (investigational drug) on a novel schedule. It is also the     aim of this research project to determine what the effects, good and/or bad, are of combining     capecitabine (Xeloda) with PHY906 (investigational drug) in the treatment of advanced     pancreatic cancer.      PHY906 is a powder from plants sold as a health food supplement in the United States. PHY906     has been used in China, Taiwan and other Asian countries as traditional Chinese medicine for     hundreds of years.      The other drug involved in this study, capecitabine is an oral form of chemotherapy already     approved by FDA in the management of colorectal and breast cancer.      Laboratory studies in animal models have shown that the combination of capecitabine and     PHY906 shrinks liver cancer, and a pilot clinical study is currently evaluating this     combination in patients with liver cancer to define the benefit. PHY906 has also shown to     decrease diarrhea related to chemotherapy in a small study performed in patients with colon     cancer treated at the Yale Cancer Center. Our recent laboratory studies have also shown that     the combination of capecitabine and PHY906 also shrink pancreatic tumors in mouse models.     This prompted us to test the combination of capecitabine and PHY906 in patients with advanced     pancreatic cancer to assess the benefit in survival as well as any decrease in side effects,     such as diarrhea caused by capecitabine.   "
196489|NCT00411788|"     Rapamune (generic name: Sirolimus®) is a drug that has been approved by the Food and Drug     Administration (government) for use in patients receiving a kidney transplant to prevent the     patient's body from rejecting the transplanted kidney. It has shown antitumor effects in the     laboratory, but has not been approved at this time for the treatment of cancer. Herceptin is     a new form of chemotherapy that has been approved by the Food and Drug Administration for the     treatment of breast cancer.      This study is designed to evaluate the effect and safety of combining Rapamune and Herceptin     on breast cancer. Rapamune and Herceptin are being combined because results from our     laboratory studies suggest that the combination of the two drugs is superior to either drug     used alone. Results from laboratory studies performed at other institutions suggest that     adding Rapamune to Herceptin may also reverse the resistance to Herceptin. Although there has     been extensive experience using Herceptin alone and Rapamune alone in human subjects, the     combination of Herceptin and Rapamune has not been previously evaluated. In addition, we hope     to better understand how these treatments work against an individual woman's tumor by     analyzing tissue samples before, and during treatment.   "
196490|NCT00411801|"     Prior to the use of plasma products, thrombotic thrombocytopenic purpura (TTP) was usually a     fatal condition. During plasma exchange therapy, patients need transfusion plasma that is     blood group specific. Transfusing a patient with an incorrect blood group may have fatal     consequences. Uniplas is a universally applicable human plasma, which can be administered     irrespective of the patient's blood group. This study will test the safety and efficacy of     Uniplas in comparison to cryosupernatant plasma in treatment of patients with TTP.   "
196822|NCT00417157|"     The purpose of this study is to evaluate the effectiveness of a modified natural cycle in     patients with previous poor response to infertility drugs and high basal FSH, prior to     proceeding to oocyte donation or abandoning fertility treatment.   "
196492|NCT00411827|"     Purpose: To develop a screening metric by examining both the characteristics of the     preoperative tear film and the intracellular signaling pathways of conjunctival goblet cells     in order to determine if there are certain characteristics which might predict those patients     who will experience serious dry eye symptoms and complications after refractive surgery.      Research Design: This study is a twelve-month prospective non-randomized investigation.      Methodology: In conjunction with psychometric questionnaires and various measures of tear     film quality (e.g. Schirmer's test, tear break up time, etc), impression cytology will be     used to assess the intracellular signaling pathways of conjunctival goblet cells and to     determine if alterations in this pathway exist. Alterations in this pathway would result in a     reduced response by the mucin secreting conjunctival goblet cells thereby promoting the     development of dry eye after refractive surgery.   "
196493|NCT00411840|"     We analyze the effects of combined intramuscular and intraarterial transplantation of BMCs in     patients with PAD. BMCs were transplanted into the ischemic limb.      After 2 and 13 months walking distance and perfusion indices were monitored.   "
196494|NCT00411853|"     We propose in this study to treat hormone refractory prostate cancer (HRPC) patients., with a     novel preparation of fermented wheat germ nutriment (FWGE), in combination with the 1st line     hormone therapy, the gonadotropin releasing hormone (GnRH), which stopped being effective.     The study will be conducted during two years with 60 patients. The efficacy will be assessed     in terms of clinical and serological response and by specific questionnaires.      This concept is based on previous reports regarding other diseases such as colon cancer,     where the addition of a new drug to a drug which previously had failed, improved the     patients' survival, the quality of life and the clinical parameters. In addition, preclinical     data have shown activity of that regimen in prostate cancer cell lines and in animals'     models.      FWGE exhibits a wide variety of mode of actions, in a wide range of malignant tumors. It     increased the natural immune responses while decreasing the systemic inflammation often     present in cancer patients. It reduced the growth of human prostate tumor xenograft in mice     and prolonged their survival. It delayed disease progression, increased overall survivals,     improve quality of life and reduce oxidative stress.      The long-term goal of this research is that the addition of FWGE to a drug which previously     had failed, would slow down disease progression in patients with advanced and thus refractory     cancers, improving the patients' quality of life, their clinical parameters and survival.   "
196495|NCT00411866|"     The purposes of this study are to determine if there is a difference in how SB-773812 is     distributed through the bloodstream before and after multiple doses of ketoconazole have been     given and to determine if there is a difference in how safe and well tolerated SB-773812 is     when given on its own and given with ketoconazole.   "
196521|NCT00412217|"     This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo     in participants with resected head and neck squamous cell cancer who are receiving concurrent     chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either     erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease     progression or unacceptable toxicity.   "
196496|NCT00411879|"     A randomized controlled trial did not show benefit of vasopressin versus epinephrine in     inhospital cardiac arrest. Preceding laboratory data suggest that combined vasopressin and     epinephrine ensure long-term survival and neurologic recovery. Also, postresuscitation     abnormalities mimic severe sepsis. The investigators hypothesized that combined vasopressin     and epinephrine during cardiopulmonary resuscitation (CPR), and steroid supplementation     during and after (when required) CPR may improve survival in cardiac arrest.   "
196497|NCT00411892|"     This trial is conducted in the United States of America (USA). This trial will compare the     changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy     versus pioglitazone treatment alone.   "
196498|NCT00411905|"     We are evaluating the efficacy of the association of Low dose Cytarabine in association with     Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes.     Our aim is to decrease transfusion requirements and if possible induce a complete or at least     a partial remission.   "
196499|NCT00411931|"     Compare relative exposure in the younger age group in order to supplement the PK profile     already determined in older children and adults   "
196500|NCT00411944|"     An evaluation of the effects of genetically determined variant metabolizing and transporting     proteins involved in the disposition of the immunosuppressive drug tacrolimus in renal     transplant recipients. In a five year follow-up study tacrolimus dose-corrected exposure     changes significantly and the effect(s) of single nucleotide polymorphisms of the     CYP3A4/CYP3A5 and MDR1 genes on the latter is assessed in this study.   "
196501|NCT00411957|"     Several studies from HIV-NAT have demonstrated high nevirapine, indinavir, saquinavir and     lopinavir/r levels when compared to Caucasian patients. Until now, the pharmacokinetics of     atazanavir have not been explored in a Thai population. We postulate that ATV levels, as with     other PIs, are higher in Thai people. Therefore, the level of ATV in ATV/RTV 300/100 OD may     be higher than the acceptable range and could be associated with ATV related toxicity.   "
196502|NCT00411970|"     The aim of the present study is to compare the functional and clinical differences and     advantages between a standard operating system and a newly developed even smaller system for     pars plana vitrectomy.      The present study may work out the possible advantages and disadvantages between the     routinely used 20-gauge vitrectomy system and the newly developed 23-gauge device.   "
196503|NCT00411983|"     With HIV/AIDS increasingly considered a chronic disease, 24-, or 48-week data from     antiretroviral studies are no longer sufficient. Only with long-term follow-up and outcome     data will shed some much-needed light on the answers of questions that have stumped us for     several years. Data from a large observational cohort of patients treated with combination     antiretroviral therapy will provide further insights into the long-term safety and durability     of various antiretroviral therapeutic approached, the efficacy of HIV viral load and CD4 cell     counts as predictors of disease progression and mortality, and the importance of adherence.   "
196504|NCT00411996|"     We believe that there is a strong rationale for the study of IDV/r 600/100 bid as a     boosted-PI combination that, in the presence of RMP, is able to produce a satisfactory PK     profile associated with adequate antiretroviral potency, tolerability and efficacy.   "
196505|NCT00412009|"     Tuberculosis (TB) patients who receive inadequate treatment or do not complete therapy are     more likely to remain infectious, thus contributing to the continuous spread of TB infection     in communities. Despite the widespread use of Directly Observed Therapy, defaulters remain an     important problem in TB control programmes. In Sénégal, defaulters rate reach 30%, which is     hampering dramatically the effectiveness of control. New strategies to deliver treatment to     TB patients and ensure proper adherence that are adapted to the local situations are urgently     needed.      Objectives      The overall objective of the project is to improve tuberculosis treatment success rates in     Sénégal. The specific objectives are:        1. to assess the current situation of tuberculosis (TB) in Sénégal        2. to identify the determinants of cure,        3. to develop measures to improve patient’s compliance with the treatment that are adapted          to the local situation, acceptable, affordable and sustainable        4. to evaluate the impact of these measures on TB control.      Methods      The proposed research seeks to develop and test innovative methods to improve cure rates in     TB patients. It will explore the factors of success of TB treatment using inter-disciplinary     approach, integrating social sciences and economic analyses into TB research. The project is     composed of 3 comprehensive phases:        -  Phase 1: baseline assessment of the TB situation.        -  Phase 2: anthropological study, investigating various domains contributing to patients          cure using a range of qualitative research methods. At the end of this investigation, it          is expected that determinants of care will be clearly identified. On this basis,          suitable methods for improving patients’ adherence to treatment will be tailored and          developed.        -  Phase 3: these methods will be tested and compared using a cluster randomised controlled          trial design, in populations served by defined health centres. Their efficacy will be          measured in terms of improvement of the classical TB control programme indicators (cure          rate, defaulter rate, failure rate, death rates). The methods will also be evaluated on          their acceptability by the TB patients and the communities and on their feasibility          (duration : 24 months).      Expected results:      Methods to improve patients’ adherence to treatment that are affordable, acceptable and     sustainable will be developed and tested according to qualitative and quantitative criteria.   "
196506|NCT00412022|"     The HOBOE study was amended in November 2009, and, after reaching enrollment of the first 500     patients, the study began recruiting premenopausal patients only. The primary objective of     the extended study is to compare disease free survival in premenopausal patients with early     breast cancer. Patients receive triptorelin and are randomized in a 1:1:1 fashion to receive     tamoxifen or letrozole, or letrozole + zoledronic acid.      The purpose of the HOBOE study, Version 1, was to compare the adjuvant hormonal therapy     treatments of Tamoxifen, Letrozole and Letrozole + Zoledronate for their effects on bone loss     in breast cancer patients. Postmenopausal and premenopausal patients were eligible, the     latter also receiving monthly triptorelin. Upon reaching the enrollment of the first 500     patients in March 2010, the study began recruiting premenopausal patients only.   "
196507|NCT00412035|"     The purpose of this six site multi-center study is to determine if BTX-A can alleviate the     post-operative pain and improve the functional and quality of life outcomes of children with     limb length discrepancy or angular deformity undergoing limb lengthening or deformity     correction.   "
196508|NCT00412048|"     The aim of the protocol is to study the resting brain activation profile of 3 groups of     people, using a new fMRI procedure, called fMRI-SAM. fMRI-SAM will be applied to 25     Alzheimer's disease (AD) patients, 25 patients suffering from amnestic - mild cognitive     impairment (MCI) - a clinical picture which may be a prodromal form of AD - and 60 healthy     controls. The first analysis of the data will search differences of brain activation profiles     between the 3 groups. In the second step, the investigators will study the predictive value     of fMRI-SAM to detect MCI patients who will later convert to AD.   "
196509|NCT00412061|"     The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment     with depot octreotide prolongs progression free survival compared to treatment with     octreotide alone in patients with advanced carcinoid tumor.   "
196510|NCT00412074|"     The purpose of this study is to determine the effectiveness and safety of maternal and infant     vitamin D supplementation as a function of ethnicity and latitude in the prevention of     vitamin D deficiency in the breastfeeding mother-infant pair. The findings of this study will     generate important new information for health care professionals and policy makers with     regard to vitamin D requirements and the potential benefit to both mother and infant   "
196511|NCT00412087|"     Science News (October 2004) called vitamin D deficiency a silent epidemic in America, with     no group unaffected. Using new guidelines of optimal vitamin D levels, more than 90% of     African American women now suffer from vitamin D deficiency. Deficiency during pregnancy has     profound effects on the developing fetus. Other systems besides bones are affected by vitamin     D deficiency, including an increased risk of autoimmune diseases such as rheumatoid     arthritis, multiple sclerosis, type I diabetes, and certain cancers.      This study proposes to examine and manage vitamin D levels in more than one thousand women in     an underserved population in South Carolina. The women will be from the patient population     seeking OB/GYN and Pediatric services through Eau Claire Cooperative Health Centers, Inc.     (ECCHC), a network of ten clinics in three counties in the center of the state approximately     70 miles from Charleston, SC. ECCHC is one of approximately 1000 community health centers     supported through Health and Human Services' (HHS) Health Resources and Services     Administration's (HRSA), Bureau of Primary Health Care.      The research objectives for this project will be managed through the Pediatric Nutritional     Sciences Research Center of the Children's Research Institute at the Medical University of     South Carolina, Charleston, SC, in collaboration with ECCHC. The research aims will evaluate     vitamin D levels and possible contributing factors to the levels in pregnant women. Women who     present to ECCHC within the first trimester of pregnancy will be randomized to one of two     doses of vitamin D supplementation shown to be effective in other groups. Each pregnant     mother will begin supplementation during the 12th week of pregnancy and will be followed     closely throughout pregnancy for one year to determine the effectiveness of supplementation     on vitamin D status, overall health of mother, and of her infant following delivery.      We expect to observe severe vitamin D deficiency in a considerable percentage of the mothers     and their infants who receive care at ECCHC, especially those individuals with darker     pigmentation. When the extent of vitamin D deficiency within each racial/ethnic group is     better defined and their supplementation requirements identified, we will be better able to     establish guidelines for supplementation and health maintenance, and set policy     recommendations for the dietary recommended intake of vitamin D. Those women and their     infants identified as deficient in vitamin D will be important in establishing community     health care policies for vitamin D surveillance and supplementation strategies. The results     will allow us to implement specific dietary and/or medical interventions aimed at correcting     hypovitaminosis D in the population in this study and other similar populations being served     by the more than 1000 community health centers nationally.   "
196512|NCT00412100|"     The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged     release tablets have improvement in symptoms of constipation compared to subjects taking     oxycodone prolonged release tablets alone.   "
196513|NCT00412113|"     The purpose of this study is to investigate whether an aggressive multi-risk factor     management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in     greater percentage of patients achieving blood pressure and low density lipoprotein     cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol     Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach     (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with     hypertension and additional risk factors, including dyslipidemia.   "
196541|NCT00412490|"     Primary Objectives:        1. To characterize smoking behaviors and body image in patients with oral cavity cancer          prior to and following surgical procedures.        2. To examine the relationship between smoking status and body image in this sample of head          and neck cancer patients.        3. To examine the influence of smoking status and body image on quality of life outcomes.   "
196514|NCT00412126|"     Coronary artery disease is a process that results in “hardening of the arteries”. When the     arteries that supply blood and oxygen to your heart muscle become clogged or narrowed, a     heart attack may result, or you may feel chest discomfort (angina) – sometimes even while     resting. One approach to treating this condition is a balloon procedure known as coronary     angioplasty.      The major limitation of coronary angioplasty is renarrowing of the artery (restenosis) in the     first six months following the procedure requiring either repeat angioplasty or referral for     bypass surgery. Patients with diabetes have always been identified as having higher rates of     restenosis and poor outcomes following angioplasty, despite some important scientific     advances. We think that the level of blood sugar control at the time of angioplasty and in     the following months may be related to the extent of restenosis.      We expect that a reduction in blood sugar with insulin may, in turn, reduce the restenosis     process and improve your long-term outcome.   "
196515|NCT00412139|"     Patients treated by chronic renal replacement therapy are exposed to cardiovascular problems     and suffer from an accelerated and sever atherosclerosis. Classical risk factors for     atherosclerosis and cardiovascular diseases (CVD) do not explain the full risk of CVD in the     dialysis patients. Additional risk factors are therefore likely to exist. The uremic syndrome     is attributed to the progressive retention of a large number of compounds, which under normal     conditions are excreted by the healthy kidneys. Uremic toxins such are parathormone (PTH),     vitamin D and phosphates, cause development of renal osteodystrophy (ROD), i.e. disordered     calcium and phosphate metabolism. Both conditions of hyperparathyroid and adynamic bone     disease (ABD) lead to an elevated calcium x phosphate product and increased vascular     calcification, which might occur in intimal and medial layer of the vessel wall. It is     important to consider these processes separately, as the vascular consequences (occlusion     with atheromatosis and vascular stiffening through medial calcification) are different.     Moreover, the difference between uremic and non-uremic intimal plaque is not the size but its     composition, with markedly increased calcium content. Hence, these observations have an     important socio-economic impact because of the increased cardiovascular morbidity and     mortality.      The investigators hypothesized that uremic toxins in dialysis patients influence directly     and/or indirectly the development of atherosclerosis, vascular calcifications and CVD.   "
196516|NCT00412152|"     The primary objective of this study is to demonstrate that subjects with moderate to severe     non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in     symptoms of constipation compared to subjects taking oxycodone prolonged release tablets     alone.   "
196517|NCT00412165|"     This randomized control study (sponsored by the NIH, NIDDK) is aimed at reducing BMI in     overweight adolescents at risk for the development of type 2 diabetes. The study will examine     whether an integrated primary care, web and cell-phone-based intervention can produce initial     and sustained improvements in anthropometric, behavioral, metabolic, and physiological     outcomes in overweight adolescents. The primary goal is to reduce BMI (Body Mass Index)in     overweight adolescents.   "
196518|NCT00412178|"     Previously we demonstrated the beneficial effects of an Internet-based glucose-monitoring     system (IBGMS) in people with type 2 diabetes mellitus. The “Diabetes Phone”, a cellular     phone with a glucometer integrated in the battery pack, was launched in Korea in 2003. Here     we test the short-term effectiveness of the diabetes phone for glucose control and compare it     with that of IBGMS.   "
196519|NCT00412191|"     This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine     XR in healthy male and female volunteers   "
196522|NCT00412230|"     The purpose of this study is to determine whether insulin resistance might affect the     pathogenesis of hypertensive disorders in pregnancy since midtrimester. Furthermore, markers     of vascular and placental injuries, of oxidative stress and inflammation will be evaluated.   "
196523|NCT00412243|"     The goal of this clinical research study is to find the highest tolerable dose of the drugs     clofarabine and cyclophosphamide that can be given together in the treatment of relapsed or     refractory ALL. The safety of the combination treatment will also be studied.      Objectives:      Phase I:        1. To establish toxicities and safety of the proposed combination        2. To establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the          combination to proceed with the phase II part of the study           Phase II:        3. To establish the efficacy (complete and overall response) of the proposed combination.        4. To analyze pharmacokinetic (PK) and pharmacodynamic (PD) properties of clofarabine as          well as the impact on DNA repair of leukemic blasts with the proposed combination.   "
196524|NCT00412256|"     The primary hypothesis constitutes that the fish-oil preparation (Omegaven) is superior to     the preparation based on Soja-oil (Lipovenös)to reduce signs and symptoms in patients with     active rheumatoid arthritis.   "
196525|NCT00412269|"     The purpose of this study is to determine the effect of menopause on obesity, energy balance,     and insulin in postmenopausal, obese women.   "
196526|NCT00412295|"     The purpose of this study is to:        1. determine the safety of wavefront guided PRK        2. evaluate the efficacy of wavefront guided PRK        3. evaluate the differences in visual quality after treatment of wavefront guided PRK   "
196527|NCT00412308|"     The study will compare outcomes between individuals with sub-acute, ventilator-dependent     tetraplegia using high (20 cc/kg) vs. low (10 cc/kg) tidal volumes during mechanical     ventilator support.   "
196528|NCT00412321|"     The purpose of this study is to evaluate of the study of different CNTO 328 doses and     schedules and to see if CNTO 328 has any effect on Non-hodgkin's Lymphoma, Multiple Myeloma     or Castleman's disease.   "
196529|NCT00412334|"     This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in     patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous     treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one     of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS     180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus     Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus     1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of     treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the     target sample size is 100-500 individuals.   "
196530|NCT00412347|"     Increasing evidence from clinical studies in Intensive Care Unit (ICU) settings indicates     that insulin infusion can improve outcome measures for patients with hyperglycemia (high     blood sugar) independent of a previous diagnosis of diabetes mellitus. This improvement in     health could also apply to patients that have high blood sugars in various other non-critical     care areas of the hospital as well. However, the data that shows improvement in health     outcomes has been collected from wards that have a lower patient to provider and patient to     nurse ratio, resulting in the ability for a much tighter control of the insulin infusion. We     hypothesize that tight blood glucose control will provide the same benefits for patients in     non-intensive care units settings but that these protocols may lead to a higher incidence of     hypoglycemia (low blood sugar) and potentially to adverse outcomes in patients.      This study aims to determine the clinical outcome of patients treated with insulin infusion     as well as the rate of hypoglycemic episodes in non-intensive areas. We will conduct a chart     review of patients treated with insulin infusions in non-critical wards at Emory University     Hospital during the period of 7/1/04 to 6/30/05. Medical records of all patients treated with     intravenous insulin infusion protocols will be analyzed. Data on demographics, laboratory     values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition     at discharge will be analyzed.   "
196531|NCT00412360|"     This study is a Phase III, randomized, open-label, multi-center, prospective study of single     umbilical cord blood (UCB) transplantation versus double UCB transplantation in pediatric     patients with hematologic malignancies.   "
196532|NCT00412373|"     The purpose of this study is to measure the effectiveness and assess the safety of different     dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER)     in patients who are experiencing an acute episode of schizoaffective disorder.   "
196533|NCT00412386|"     Bicuspid aortic valve (BAV) is a form of congenital heart disease (the person is born with     it). With BAV, the heart valves in the aorta (the blood vessel that takes blood away from the     heart to the body) are not formed right. A person with BAV has only 2 leaflets instead of     three and the valve leaflets are often thickened. This can result in the block of blood flow     across the valve (aortic stenosis) and/or valve leakage (aortic valve regurgitation).      From our experience at least 1/3 of patients with BAV will eventually develop complications.     Many patients with BAV do not develop significant problems until well into adulthood. The     most common problem in BAV patients is aortic dilatation and/or dissection. At this point, we     do not know on who or why aortic dilatation or dissection occurs.It is unclear whether the     enlargement is because of abnormal blood flow patterns, as a result of the shape of the     bicuspid valve, or whether it is because the way the aortic valve and/or vessel is formed. In     other words, the abnormal shape of the aortic valve may cause blood to flow in a different     way than it normally would, causing damage to the aorta as blood leaves the heart. There may     be a problem with the way the aortic valve connects to the aorta, which causes the aorta to     get larger or break down over time. It is also possible that the wall of the aorta in     patients with BAV is weaker than it would be in patients without BAV. At this point, we do     not know. It is believed by the investigators that if we can determine why the aorta gets     larger or tears, we can minimize the effects or prevent them altogether.      This study will collect blood and cardiac MRI images from forty-five (45) patients at     Children's Healthcare of Atlanta Egleston. There will be a study group (patients with BAV)     and a control group of patients (patients scheduled for a cardiac MRI but without BAV).      All enrolled patients will have blood drawn by nursing staff from a peripheral vein and     collected in tubes for testing the day of their MRI scan. This test is called a plasma matrix     metalloproteinase level. It is believed that patients who have bicuspid aortic valves and     dilated aortas have high plasma levels of this protein. This study will compare the MRI     images and plasma matrix protein levels of all the patients participating in the study.   "
196534|NCT00412399|"     The specific aim of this study is to compare the rate of negative work role events in     individuals with rheumatoid arthritis compared to healthy controls.   "
196563|NCT00421590|"     This study will assess the effect of concomitant antacid on the pharmacokinetics and     pharmacodynamics of SMC021   "
196762|NCT00426673|"     The primary objective of this Phase I study in 15 adult subjects suffering from epilepsy and     chronically treated with phenytoin monotherapy is to evaluate the effect of steady-state ucb     34714 administration on the steady-state plasma levels of phenytoin.   "
196535|NCT00412412|"     The goal of this clinical research study is to study the drug CNF2024 as a single agent or in     combination with trastuzumab in patients with advanced breast cancer and to:        -  find the highest dose of the drug CNF2024 as a single agent or in combination with          trastuzumab that can be given safely        -  measure levels of CNF2024 as a single agent or in combination with trastuzumab in blood        -  determine if CNF2024 as a single agent or in combination with trastuzumab can stop          breast cancer cells from growing   "
196536|NCT00412425|"     Primary Objectives:        -  Safety of palonosetron administered for control of nausea and vomiting in patients with          metastatic melanoma receiving biochemotherapy.        -  To determine the patterns and severity of nausea and vomiting in two groups of patients          with metastatic melanoma receiving biochemotherapy with palonosetron premedication using          two schedules of palonosetron administration.   "
196537|NCT00412438|"     The atrial fibrillation (AF) is the most common cardiac rhythm disturbance that is     responsible for substantial morbidity and mortality independent of associated heart disease     or other risk factors. Even in the absence of preexisting cardiovascular disease, AF remains     significantly associated with excess mortality rates. The current unsatisfactory treatment     for AF comes from lack of understanding of the pathophysiology of AF. The purpose of this     study is to identify gene polymorphisms that confer susceptibility to atrial fibrillation.     Patients with AF（N=500） and healthy volunteer（N=1000） without AF are enrolled in this study.     Patients with coronary artery disease, severe valvular heart disease, cardiomyopathy or heart     failure were excluded from the study.   "
196538|NCT00412451|"     A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical     PVD induction for treatment of patients with DME.   "
196539|NCT00412464|"     This study will evaluate the use of a blood thinner, fondaparinux, which is approved for use     in adults (not in children) in a children aged 1-18 years. Subject with a blood clot     (thrombosis) or heparin-induced thrombocytopenia who need to be on a blood thinner will be     eligible to participate. Subjects will receive a once daily dose of fondaparinux followed by     blood tests at 2, 4, 12, and 24 hours after the first dose in order to determine the proper     dose for this age group. The hypothesis is that children receiving fondaparinux will be able     to receive a once daily dose. The currently available alternative agent, enoxaparin, needs to     be given twice daily. In addition, an evaluation of the safety of this medication will be     made by assessing for side effects, especially bleeding.   "
196540|NCT00412477|"     To evaluate the safety of LFn-p24 administered at three different doses with Alhydrogel given     intramuscularly      To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given     intramuscularly   "
196542|NCT00412503|"     Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some     types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas)     cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly     needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and     TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both     drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never     been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting     toxicities of each drug when associated and to assess efficacy of the combination.   "
196543|NCT00412516|"     The previously conducted JEV01 study looked at the immunogenicity and safety of the     concurrent administration of Japanese Live Attenuated SA 14-14-2 and measles vaccines at the     one month post vaccination time point. The purpose of the JEV01 study was to help ensure the     safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its     use in routine EPI programs. As a follow-on to JEV01, this study will enroll those infants     who received both vaccines and completed the JEV01 study. This study, however, will provide     crucial data to help ensure the long-term immunogenicity of the concurrent administration of     these vaccines and provide valuable information to determine the use of these vaccines in     routine immunization programs. This study is planned because in the original protocol for     JEV01, long-term data points were not included. The hypothesis is that children who receive     JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time have long-term (24     and 36 months post vaccination) protection against these diseases at the same level as those     who receive the vaccines at different intervals.   "
196544|NCT00412529|"     This exploratory study is designed to determine the early viral kinetic profile during     treatment with telbivudine or entecavir at multiple time points over 12 weeks.   "
196545|NCT00412542|"     Objectives:      1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy     with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or     progressive malignant gliomas.      1.2 To determine the rate of measureable clinical response in patients treated with     Thalidomide and CPT-11.      1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected     toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas.      1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker     for treatment effect.   "
196546|NCT00412555|"     This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in     children during the flu season. Children who would benefit from influenza prophylaxis when     influenza is circulating in the community will receive treatment with Tamiflu syrup (or     capsules) 30mg-75mg once daily (dependent on body weight) for 6 weeks. Safety data and     influenza symptoms will be recorded throughout the study. The anticipated time on study     treatment is <3 months, and the target sample size is <100 individuals.   "
196547|NCT00412568|"     The purpose of this study is to:        1. evaluate the safety and efficacy of conventional PRK in U.S. Army personnel who have          naturally occurring myopia with or without astigmatism.        2. compare the data from this control group to study groups undergoing wavefront guided          PRK.   "
196548|NCT00412581|"     Primary Objectives:      1. To determine the maximum tolerated dose (MTD) of intravenous DTIC during the first 2     cycles (6 weeks) of treatment when administered in combination with a fixed dose of oral     Lenalidomide in patients with metastatic malignant melanoma previously untreated with     systemic chemotherapy.      Secondary Objectives:        1. To define the recommended Phase II doses of Lenalidomide and DTIC when administered as          combination therapy.        2. To evaluate the safety and toxicity profile of combination Lenalidomide plus DTIC.        3. To evaluate the preliminary efficacy of combination Lenalidomide plus DTIC.   "
196549|NCT00412594|"     The goal of this clinical research study is to learn if treatment with 2CDA (cladribine)     followed by treatment with rituximab can help to control HCL. The safety of this combination     treatment will also be studied.   "
196550|NCT00412607|"     The primary objective is to provide additional corroborative safety and efficacy data for the     Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular     Tachycardia.   "
196551|NCT00412620|"     The objective of this study is to explore the safety and efficacy of ABT-925 involving     patients who meet the DSM-IV-TR (Diagnostic and Statistical Manual of Medical Disorders,     Fourth Edition Text Revision) criteria for an acute exacerbation of schizophrenia or     schizoaffective disorder.   "
196552|NCT00412633|"     PACE Project researchers at UCSD are conducting a 2-year study to test the Men in Motion     program. The study aims to learn more about how to help men lose weight, become more     physically active, and improve their dietary habits. The study is sponsored by the National     Institutes of Health.   "
196553|NCT00421460|"     The purpose of this study is to evaluate the response of a treatment with testosterone     undecanoate and determine the levels of total and free testosterone in hypogonadal patients     with erectile dysfunction.   "
196554|NCT00421473|"     Malarone® (atovaquone/proguanil) is frequently used in malaria prophylaxis. Unfortunately,     there are indications that certain anti-HIV agents may decrease atovaquone plasma levels by     induction of atovaquone metabolism.      For travelling HIV patients, the clinical consequences of these possible drug drug     interactions are serious, since a diminished exposure to the anti-malarial drug will result     in suboptimal prophylaxis of malaria and potential development of drug resistant strains of     Plasmodium falciparum.      The purpose of this study is to find out if HIV patients using HAART regimes with either     lopinavir/ritonavir, atazanavir/ritonavir or efavirenz have lower atovaquone plasma levels     than healthy volunteers after a single dose of atovaquone/proguanil.   "
196555|NCT00421486|"     Human papillomavirus (HPV)-infection belong to the most common sexually transmitted diseases     worldwide. HIV-infected men having sex with men /MSM) are strongly associated with a higher     prevalence of genitoanal HPV-infection, and perianal HPV-infections have been detected in up     to 90% of HIV-positive men. The data concerning the incidence of oral HPV-infection in     HIV-positive men, especially in the era of highly antiretroviral therapy, are conflicting.     Thus, this prospective study mainly focuses on the incidence and prevalence of oral     HPV-infection, spectrum of HPV-types, and oral high-risk HPV viral load in HIV-positive men.   "
196556|NCT00421499|"     Regular intake of cocoa-containing foods is linked to a considerably lower cardiovascular and     all-cause mortality in observational studies. Short-term intervention studies indicate that     high doses of cocoa improve endothelial function and reduce blood pressure (BP), but the     clinical impact of long-term intake of small dietary amounts of cocoa on BP and the     underlying BP lowering mechanisms are unclear. We hypothesized that cocoa consumption lowers     blood pressure by augmentation of the circulating vasodilative nitric oxide (NO) pool due to     the action of the cocoa polyphenols at the vascular endothelium.      To test this hypothesis, we will conduct a randomized single-blind, parallel group study in     subjects with mild essential hypertension to evaluate the effects of polyphenol-rich dark     chocolate versus polyphenol-free white chocolate on blood pressure and plasma levels of cocoa     phenols, circulating bioactive nitric oxide, and plasma markers of oxidative stress. After a     7 day cocoa-free run-in period, 44 subjects will be 1:1 randomized to receive over 18 weeks     daily doses of either dark chocolate (6.3 g per day with a total of 30 mg of polyphenols and     30 kcal) or polyphenol free white chocolate (5.6 g per day with 30 kcal, containing similar     amounts of macronutrients, electrolytes and vitamins). Subjects will be counseled to maintain     an isocaloric diet and to abstain from other cocoa products during the study. Blood pressure     and plasma parameters will be assessed in each subject after the run-in period and after 6,     12, and 18 weeks of treatment.   "
196557|NCT00421512|"     The purpose of this study is to test the safety of bevacizumab and sunitinib given in     combination for kidney cancer. The drugs act to stop blood vessel growth but in different     ways. They have not been studied together in a previous study. We also want to find out what     effects (good and bad) the combination of bevacizumab and sunitinib have on you and your     tumor.   "
196558|NCT00421525|"     This is a Phase I/II, open-label, multi-center study conducted in patients with recurrent or     refractory multiple myeloma who have failed at least two prior standard systemic treatments.   "
196559|NCT00421538|"     CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to     determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine)     injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein     thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks.     Additionally, the study aims to determine if the 6 week course of treatment with     therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency     of post-thrombotic syndrome (PTS) at 1 year.   "
196560|NCT00421551|"     The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able     to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI     + darunavir/r in HIV infected patients with full viral suppression.   "
196561|NCT00421564|"     This study is to examine the effect and safety of the study drug,Danggui Buxue Tang, on     menopausal symptoms of hot flushes and sweating and to determine whether the patient's     quality of life will be improved.   "
196562|NCT00421577|"     There is a simple laboratory technique for localization of caries associated bacteria on     tooth surfaces by taking an impression of the teeth with a material containing sucrose.      The purpose of this study is to check whether the technique can be incorporated into dental     clinics as diagnostic tool comparing to other diagnostic methods available.   "
196564|NCT00421603|"     The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety     and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence.     Since both of these medications have independently shown promise in helping with cocaine     abuse we are proposing that together they may be even more successful in the treatment of     cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of     the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine     abstinence among cocaine-dependent patients. This study includes free treatment for cocaine     dependence that includes medication.   "
196565|NCT00421616|"     Several studies have reported greater weight loss when following high meat-protein diets but     limited studies have studied high plant-based protein diets. Thus we aim to investigate the     effect of high protein diets in weight management and also to investigate the superior     protein source in achieving this effect. In addition, we aim to develop dietary intervention     strategies that are realistic and sustainable.   "
196566|NCT00421629|"     The purpose of this study is to assesses interventions aimed at improving the distributional     impact of a community based health insurance scheme in rural India.   "
196567|NCT00421642|"     This is an open-label study of 20 patients designed to demonstrate the safety, tolerability     and preliminary evidence of benefit of adalimumab in the treatment of subjects with     Ulcerative Colitis, both in patients who have never received anit-TNF agents and in those who     have lost response or developed intolerance to previous infliximab therapy.   "
196568|NCT00421655|"     The trial is performed to evaluate the efficacy and safety of specific immunotherapy with     Grazax for treatment of grass pollen induced allergy.   "
196569|NCT00421668|"     A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or     placebo among 2400 children born to HIV-negative Tanzanian mothers.   "
196570|NCT00421681|"     The purpose of this study is to assess the comparative effects of two different ways of     enhancing long-term adherence to and benefits associated with participation in the     evidence-based, Fit and Strong multi-component exercise intervention for older persons with     lower extremity osteoarthritis.   "
196571|NCT00421694|"     Following radical prostatectomy (RP), about 20% to 40% of the patients with prostate cancer     (PCa) exhibit pathological parameters which are associated with a high risk of disease     recurrence. The rationale for NHT is based on the theory that androgen ablation induces PCa     apoptosis which induces a regression of the primary tumor bulk before RP. However the use of     NHT prior RP is highly controversial. In spite of these unenthusiastic results, the relative     short time of treatment and the use of different drugs from those utilized in other trials     might still to make this regimen attractive in terms of drug related side effects and     effectiveness. In this regard, Bicalutamide presents unique characteristics since it work     differently respect to other anti-hormonal agents by interfering on both genotropic and     non-genotropic mechanisms of androgen receptor   "
196572|NCT00421707|"     This is a double-blind, placebo-controlled, randomised crossover study to investigate the     efficacy and safety of GW876008   "
196573|NCT00421720|"     This prospective, randomized, multicenter, open-label study will compare two analgesia-based     regimens for sedation (remifentanil/propofol vs. sufentanil/propofol) in medium to long-term     ventilated intensive care patients in terms of efficacy, safety and resource utilization.      The special characteristics of intensive care patients (organ insufficiencies etc.) regularly     cause an accumulation of the analgesics, sedatives and adjuvants used. Clinically, this     complicates the calculation of weaning and extubation times, often making mechanical     ventilation necessary for longer periods than desired and also extending the stay of patients     in the intensive care unit. Reducing weaning times and the duration of intensive care     treatment by optimizing analgesia/sedation could furthermore lead to a reduction in typical     complications such as ventilator-associated pneumonia or delirium.      The demands on an ideal analgesic are analgesic efficacy without severe cardiopulmonary     depression and rapid onset of effect and in particular a short dura-tion of effect and     absence of accumulation or development of active metabolites. Remifentanil is an ultra-short     acting µ-agonist which is, due to its molecular structure, metabolized organ-independently by     unspecific blood and tissue esterases with the substance being degraded within only a few     minutes and the resulting metabolites being virtually ineffective at the µ-receptor.     Sufentanil, on the other hand, is mainly metabolized by the cytochrome P-450-3A4 enzyme in     the liver and small intestine.      To date, only one study with a small sample size is available on the comparison of the     effectiveness and safety of remifentanil and sufentanil when used for long-term     analgesia/sedation.   "
196574|NCT00421733|"     The study objective was to evaluate the safety of paricalcitol capsules and the efficacy of     paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD)     who have Type 2 diabetic nephropathy and are receiving optimal angiotensin converting enzyme     (ACE) inhibitor and/or angiotensin II receptor blocker (ARB) therapy.   "
196575|NCT00421746|"     The purpose of this study is to determine whether piboserod, a serotonin-4 receptor     antagonist, is effective for the treatment of patients with congestive heart failure.   "
196576|NCT00421759|"     The long-term goal of this project is to develop a non-invasive, noise-based technique for     enhancing somatosensation and thereby improving balance control in elderly fallers and older     adults with somatosensory deficits.   "
196590|NCT00424346|"     The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose     regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to     7.5 mg/week), compared to placebo in patients with active rheumatoid arthritis (RA). The     study investigated the magnitude of effect as well as onset of effect for the different dose     regimens.      The primary objective of the extension studies was to assess long-term safety and     tolerability of canakinumab (ACZ885) in patients with active RA. CACZ885A2201E1 evaluated     this objective in patients who had participated in the core study (CACZ885A2201) and     CACZ885A2201E2 did the same in patients who completed the first extension study.   "
196591|NCT00424359|"     This is a study comparing clinical tests of walking and balance. The goal of this study is to     discover which of those tests are best at predicting walking problems due to MS.   "
196592|NCT00424372|"     To evaluate the safety of the long-term use of pregabalin.   "
196577|NCT00421772|"     Isolated uni or bilateral mild cerebral ventriculomegaly represents the most frequent “minor”     cerebral anomalies discovered by antenatal echography. There are not French data making it     possible to specify the incidence and the prevalence of this pathology and international data     of the prevalence are very heterogeneous, going, according to the published series, of 1.48     to 22 per 1000 births.      The prognostic of ventriculomegaly remains dubious : the studies have small populations, are     for the majority retrospectives with a short and often vague follow-up. The announced rate of     after-effects varies between 0 and 48 %.      The objective of this study is to evaluate the neuropsychological development until the 5     years age of the children for whom a prenatally diagnosis of mild isolated ventriculomegaly     was carried (absence of another cerebral or extra-cerebral anomaly in imagery and a negative     aetiology). This prospective cohort will be compared with children for whom no neurological     anomaly was prenatally detected.      The children diagnosed for an mild isolated cerebral ventriculomegaly will be identified by     the investigators among medical files of the Centers of Prenatal Diagnosis (CPDPN) of the UH     of Angers and the UH of Nantes. The patient inclusion will be done at the 2 years age after     parental agreement, with a follow-up at 5 years. The control children will be included under     the same conditions after having ensured of the normality of the echographies of 22 and 30     gestational weeks. The follow-up of these 2 cohorts will be based on the 2 years obligatory     paediatric examination, and on the network “Naitre ensemble” set up in the Pays de la Loire     Loire. In addition to the clinical routine examinations, standardized neuropsychological     examinations will be done (Brunet Lezine Revised score at 2 years, NEPSY at 5 years and ASQ     at 2 and 5 years).      This study will allow to compare the neuropsychological development at school age of the     children diagnosed for a foetal mild, apparently isolated, cerebral ventriculomegaly from     children not presenting any foetal anomaly, to evaluate the incidence of the mild isolated     ventriculomegaly, to identify the predictive factors of the neuropsychological anomalies in     the children diagnosed for ventriculomegaly and to compare (in the children diagnosed for     ventriculomegaly), the neuropsychological development at the school age of the children     having a ventricular atrium between 10 and 12 mm with those having a ventricular atrium     between 12,1 and 15 mm.      This study will allow to define the neuropsychological morbidity of the foetal mild isolated     cerebral ventriculomegaly and will allow to define the best clinical and educational follow     up of these children and their family.   "
196578|NCT00421785|"     The aim of our study is to investigate the effect of N-acetylcysteine on peritoneal small     solute clearance and removal of salt and water in prevalent CAPD patients.   "
196579|NCT00424203|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells     that remain after surgery.      PURPOSE: This phase II trial is studying how well giving doxorubicin together with     cyclophosphamide works in treating older women with stage I , stage II, or stage III breast     cancer that has been removed by surgery.   "
196580|NCT00424216|"     This study will explore what effects, if any, direct current (DC) brain polarization may     produce on mental processes, such as attention, reaction time, working memory, speed of     information processing and mood or emotional states. In DC brain polarization, a very weak     electrical current is applied to the head. This technique has been used for many years on     patients and healthy people with no known serious side effects. Studies have shown that DC     polarization can temporarily improve people's ability to think of certain words. To determine     if DC polarization can be used as a treatment for certain types of brain disorders, its     possible effects on mood and other mental abilities must be determined.      Healthy normal volunteers over age 18 may be eligible for this study.      In each of three 1.5-hour sessions scheduled a day apart, participants complete the tasks     listed below to determine the effects of polarization. For each session, electrodes are     placed on the head, arm, and hand. One set of electrodes is for brain stimulation; the second     set is used to measure the amount of skin moisture on the hand. The participants' tasks are     to:        -  Push a button on a keyboard when they see a specific item.        -  Circle a number or make a mark on a line to indicate how much they feel a particular          emotion or sensation at that time.        -  Answer questions about themselves, or their opinions on certain topics.        -  Look at several pictures and say how emotional they think they are.        -  Read about an imaginary situation and say what they would do in that situation.        -  Choose between decks of cards to try to win money.        -  Compare the angles of lines.        -  Identify smells, using a scratch and sniff test.        -  At the end of the session, say how they are feeling.      Participants are called by phone on the day after each session to see how they are feeling.   "
196581|NCT00424229|"     We are evaluating the incidence of significant hematological response, according to IWG     criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of     patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System     [IPSS]) MDS with a deletion (del) 5q[31]   "
196582|NCT00424242|"     RATIONALE: Pemetrexed disodium may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Studying samples of cerebrospinal fluid and blood from     patients with cancer in the laboratory may help doctors learn how pemetrexed disodium works     in the body and identify biomarkers related to cancer.      PURPOSE: This clinical trial is studying the side effects and how well pemetrexed disodium     works in treating patients with leptomeningeal metastases.   "
196583|NCT00424255|"     This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial     comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with     head and neck cancer following surgery. Lapatinib or placebo will be administered     post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib     or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing     the recurrence of the disease in these high-risk patients.   "
196584|NCT00424268|"     The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary     function and symptomatic parameters in patients with chronic obstructive pulmonary disease     (COPD) during concomitant administration of tiotropium. The study duration will last up to 28     weeks. The study will provide further data on safety and tolerability of roflumilast.   "
196585|NCT00424281|"     Patients in intensive care units have higher risks for developing blood clots. Arixtra     inhibits blood clot formation by binding with the blood clotting factor, Xa. Critical     illnesses and, specifically, medications given in the ICU to increase arterial blood pressure     (vasopressors) may impair the absorption of drugs like Arixtra that are given subcutaneously.     The study will measure the levels of Arixtra in blood comparing those subjects who are and     those subjects who are not on blood pressure medication.   "
196586|NCT00424294|"     To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in     subjects with rheumatoid arthritis   "
196587|NCT00424307|"     The primary purpose of this study is to track patient outcomes for bilateral cochlear implant     recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive     two implants in the same operation or in two different surgeries with the initial fitting of     the devices separated by no more than six months.   "
196588|NCT00424320|"     The purpose of this study is to determine whether sodium bicarbonate is effective in the     prevention of sodium-induced nephropathy   "
196589|NCT00424333|"     To determine in subjects with Type 1 Diabetes Mellitus:        1. Whether glycemic control can be achieved at least as effectively with a) an intensive          insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH          insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular          insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens          differ only by the route of delivery of the short acting insulin.        2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if          any, on measures of pulmonary function.   "
196593|NCT00424385|"     Eligible patients will be enrolled in one of 4 cohorts where each cohort will allow 3     patients to be on study. Patients will receive both study drugs on escalated dosing schedule     until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. Once     the pre-specified 400 mg by mouth two times a day (PO BID) dosing for both drugs is reached     without toxicity, the study will close for accrual. If toxicity is noted prior to reaching     the 400 mg PO BID dosing, then the dosing schedule that is deemed safest as per study design     will be the one used for any future phase II study.   "
196594|NCT00424398|"     The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is     effective in the treatment of acute allergic conjunctivitis   "
196595|NCT00424411|"     To determine, in subjects with Type 2 Diabetes Mellitus:        1. Whether glycemic control can be achieved at least as effectively with an insulin regimen          involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection          as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH          insulin injections per day.        2. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6          months, if any, on measures of pulmonary function.   "
196596|NCT00424424|"     This study is being conducted to evaluate the safety and tolerability of the drug and to     evaluate its efficacy compared to placebo and to ibuprofen in the prevention of postoperative     dental pain in male patients.      This is an early phase trial and some specific protocol information is proprietary and not     publicly available at this time. (Full information is available to trial participants).   "
196597|NCT00424437|"     To determine, in subjects with Type 1 Diabetes Mellitus:        1. Whether glycemic control can be achieved at least as effectively with an insulin regimen          involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a          conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin          injections per day.        2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, if          any, on measures of pulmonary function.   "
196598|NCT00424450|"     Contrast ultrasound perfusion imaging (CUPI) is a novel tool for the assessment of muscle     perfusion deficits in peripheral arterial disease (PAD). In this study we want to examine the     effect of bypass surgery and balloon angioplasty on the calf muscle blood supply. We hope     find a new way of quantifying success or failure of invasive treatment strategies.   "
196599|NCT00424463|"     This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This     study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3,     randomized, double-blind, placebo control, parallel assignment, 24-week study in the     treatment of ALS. The objectives of this study are to assess the efficacy and safety of     long-term intermittent therapy with 60 mg MCI-186 to ALS patients.   "
196600|NCT00424476|"     The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on     quality of life of two different doses of belimumab administered in addition to standard     therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE)     disease.   "
196601|NCT00424489|"     MG may be neonatal, congenital, or autoimmune. Neonatal MG arises from transplacental     transfer of ACh receptor antibodies from a mother with autoimmune MG to the fetus. Neonatal     MG resolves with post delivery clearance of maternal antibodies. Congenital MG results from a     genetic defect in the ACh receptor. Patients with congenital MG do not have ACh receptor     antibodies. Both neonatal and congenital MG are excluded from this study. Autoimmune MG,     which is the most common form of MG, affects approximately 25,000 Americans. Like most     autoimmune diseases, it is associated with particular HLA genotypes, has a female     predominance, and environmental factors involved in breaking tolerance to the ACh receptor     are unknown. Patients with refractory and severe autoimmune MG will be considered candidates     for this study.      The purpose of this study is to assess the toxicity/feasibility (phase I) of autologous     hematopoietic stem cell transplantation for refractory myasthenia gravis.   "
196602|NCT00424502|"     This single arm study will evaluate the efficacy and safety of MabThera in patients with     active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced     an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and     will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on     study treatment is 3-12 months, and the target sample size is <100 individuals.   "
196603|NCT00424515|"     The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating     acral/lentiginous and mucosal melanoma which has spread to other parts of the body in     patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It     is believed that imatinib may be effective in blocking signals on certain cancer cells which     allow the malignant cells to multiply and spread.   "
196604|NCT00424528|"     The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day     and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects     with Chronic Obstructive Pulmonary Disease (COPD).   "
196605|NCT00424541|"     This study will evaluate the pharmacokinetic profile, the effect of rennin inhibition and the     relationship among pharmacokinetics, renin-angiotensin system (RAS) biomarkers, and blood     pressure lowering effects of oral doses of SPP100 in Japanese patients with mild to moderate     essential hypertension. Safety will also be evaluated.   "
196606|NCT00424554|"     The main purpose of this study is to assess the effect of a two-week pre-surgery treatment     with low-dose temozolomide (TMZ) on brain tumor methylguanine-DNA (deoxyribonucleic acid)     methyltransferase (MGMT) activity in patients with gliomas.   "
196607|NCT00424567|"     The purpose of this multi-center study is to obtain clinical data to substantiate that     Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established     (appendicular skeletal) non union fractures, when used with one of the commonly employed     commercially available allograft chip matrices.   "
196608|NCT00424580|"     Montelukast (for asthma) and desloratadine (for allergies) are effective therapy for their     current uses. Part of what happens when your allergies trigger your asthma should be     prevented by either of these drugs. This project is being conducted to determine if these     drugs are effective, either alone or in combination, on controlling asthma that is triggered     by allergies.   "
196609|NCT00424593|"     The primary purpose of your participation in this study is to help answer the following     research question, and not to provide you treatment for your condition.      Whether duloxetine once daily can help patients with Chronic Low Back Pain.      Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg     dose for the duration of the study. After the 13 week double blind period, patients     randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension     period.   "
196610|NCT00424606|"     The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an     important part of the chemotherapy regimens used in the adjuvant setting of patients with     early-stage node-positive breast cancer patients. Whether sequential or concurrent     administration of these drugs is preferable is not yet known, especially in patients with     node-negative high risk tumors.   "
196611|NCT00424619|"     The purpose of the study is to determine the best dose of Vitamin D to give to hip fracture     patients to achieve the optimal therapeutic level.   "
196612|NCT00424632|"     The purpose of this study is to determine the maximum tolerated dose and recommended phase 2     dose of PF-03814735 administered orally as single agent in patients with advanced solid     tumors.   "
196613|NCT00424645|"     Primary Objectives:        1. To evaluate the efficacy of Glucarpidase (Voraxaze) in increasing the rate of          methotrexate (MTX) clearance following high dose MTX treatment in patients with a          delayed MTX clearance.        2. To evaluate the pharmacokinetics (PK) of Glucarpidase following high dose MTX treatment          in patients with a delayed MTX clearance.        3. To evaluate the safety profile of Glucarpidase following high dose MTX treatment in          patients with a delayed MTX clearance.      Secondary Objectives:        1. To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of          intravenous (IV) antibiotics.        2. To evaluate the effect of Glucarpidase on the length of hospitalization.        3. To evaluate the effect of Glucarpidase on renal function.        4. To evaluate the effect of Glucarpidase on Quality of Life (QOL).        5. To evaluate the anti-glucarpidase antibody response.        6. To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high          dose MTX treatment.   "
196614|NCT00424658|"     When a disorder is as prevalent as sleep apnea hypopnea syndrome various medical levels and     strategies should be implicated. We to evaluate the degree of concordance in management     between a sleep reference centre and non-reference centres.   "
196615|NCT00424671|"     This study will assess the influence of moderate hepatic impairment on the pharmacokinetics     of licarbazepine after single oral administration in healthy subjects and in subjects with     stable impaired hepatic function.   "
196635|NCT00424944|"     The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already     publicly used vaccine against rabies. 40 adult male Gabonese volunteers will be enrolled and     randomly allocated to receive either malaria vaccine or rabies vaccine without the     investigator or the participants knowing what they received. They will receive 3 doses each     at one month intervals, and will be followed up for one year to evaluate safety parameters.      This is the first time this product will be tested in Africa   "
196616|NCT00424684|"     Tuberculosis (TB) is an important cause of morbidity and mortality in organ transplant     recipients. Management of tuberculosis in this setting is challenging due to the complexity     of diagnosis and the potential toxicity of anti-TB therapy, especially in liver transplant     candidates and recipients. Although the tuberculin skin test (TST) is recommended for     screening of latent tuberculosis infection (LTBI) in all candidates for liver     transplantation, the performance of the TST in this setting is less than optimal, due to a     lack of specificity (false-positive results due to interaction with BCG vaccine and other     mycobacterial infections), and a lack of sensitivity in a population that is relatively     immunocompromised. Recently, a new test named QuantiFERON-TB Gold (QFT-G) has been approved     for the diagnosis of LTBI. QFT-G detects the release of interferon-gamma (IFN-γ) by     sensitized white cells after incubation of whole blood with TB antigens. QFT-G is expected to     be more specific than TST. However, there are no studies defining the performance of QFT-G in     a population of patients on a waiting list for liver transplantation. We plan to estimate the     usefulness of the QFT-G test for the diagnosis of LTBI in a cohort of patients with end-stage     liver disease. We hypothesize that the QFT-G test will correlate better with the risk of     LTBI. This study advances research on the prevention of a serious bacterial infection that     can have devastating consequences in the post-transplant setting. The new diagnostic strategy     may more accurately determine the presence of LTBI, thereby allowing appropriate therapy.   "
196617|NCT00424697|"     Data suggests that imaging activity of the brain can measure the effects of anti-anxiety     drugs. This study will investigate the effect of GW876008 on areas of the brain involved with     thinking and emotion   "
196618|NCT00424710|"     This is a 12 month study of monthly injections of ranibizumab in subjects with polypoidal     choroidal vasculopathy as diagnosed by fluoresceins/indocyanine green (FA/ICG) angiography.   "
196619|NCT00424723|"     The purpose of this study is to find out what effects (good and bad) pemetrexed has on     patients with advanced neuroendocrine tumors.   "
196620|NCT00424736|"     Whole body imaging has no role in asymptomatic pediatric trauma patients   "
196621|NCT00424749|"     Churg-Strauss Syndrome (CSS) is a disease characterized by asthma, abnormally high amounts of     eosinophils (a type of white blood cell), and blood vessel inflammation. About 25% of CSS     patients develop kidney disease. The goal of this pilot study was to evaluate the safety and     effectiveness of Rituximab in inducing remission of kidney disease in patients with CSS.   "
196622|NCT00424762|"     The purpose of this study is to determine if rosiglitazone treatment improves integrated     cardiovascular performance in patients at risk for congestive heart failure. A second aim of     this study is to determine if treatment with rosiglitazone decreases intracellular (ectopic)     triglyceride (TG) deposition in cardiomyocytes using nuclear magnetic resonance (NMR)     techniques, and how changes in intra-myocardial lipid content relate to changes in cardiac     structure and function.   "
196623|NCT00424775|"     The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in     combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.   "
196624|NCT00424788|"     Natalizumab (TYSABRI) is a protein-based drug that is manufactured by Biogen Idec in     partnership with Elan Pharmaceuticals. Natalizumab is approved in the US and Europe for the     treatment of Multiple Sclerosis (MS). The purpose of this study is to determine whether the     amount of natalizumab (TYSABRI) that is present in your blood (plasma) can be reduced or     eliminated by separating and removing the plasma and replacing it with other fluids, a     process called plasma exchange.   "
196625|NCT00424801|"     The purpose of this study is to determine if long-term vasodilatory treatment is more     effective than the standard treatment in hypertensive patients with microvascular angina     pectoris   "
196626|NCT00424814|"     In the pre-partum phase the use of antiretroviral therapy for the mother during the last     trimester of pregnancy is mandatory. The use of HAART during pregnancy, usually two     nucleosides analogues and a protease inhibitor exposes the mother and the child to cumulate     toxicities related to both families. The aim of this study is to assess the use of a boosted     protease inhibitor without nucleoside analogue during the pre-partum phase for women with no     indication of antiretroviral therapy for their own.   "
196627|NCT00424827|"     This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and     external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic     cancer.   "
196628|NCT00424840|"     The primary objective of phase I study is to define the maximum tolerated dose (MTD) of     weekly bortezomib in combination with Carboplatin and Bevacizumab      The primary objective of phase II study is to estimate the efficacy (response rate and     progression free survival) and safety of combination therapy with Carboplatin, bortezomib and     bevacizumab as first line therapy in patients with advanced NSCLC.      The secondary objectives of this study are to estimate the time to progression, duration of     response, and overall survival   "
196629|NCT00424853|"     This is a multicenter, open-label, randomized phase II trial whose aim is to assess the     antitumor activity of two sequential schedules of docetaxel and cisplatin followed by     gemcitabine.   "
196630|NCT00424866|"     FGF-1 for the treatment of patients with peripheral arterial disease with intermittent     claudication.   "
196631|NCT00424892|"     The primary objective is to evaluate the long-term safety of desvenlafaxine succinate     sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia     syndrome.   "
196632|NCT00424905|"     To assess the effects of Bacillus clausii (Enterogermina®) on fecal microbial flora (using     Polymerase Chain Reaction - Denaturing Gradient Gel Electrophoresis - PCR-DGGE - Method) in     antibiotic-treated children with complicated acute otitis media or beta-hemolytic     streptococcal pharyngo-tonsillitis.   "
196633|NCT00424918|"     In middle schools participating in a statewide program called Take Time, we are randomizing     youth to a 10-12 week intervention using the dance mat games on the Playstation2 (like Dance     Dance Revolution). This program is testing feasibility of using the dance mats as a way to     increase activity during the school day. We are using Groove Masters as a peer-mentored     mechanism to keep track of the activity of youth in the intervention compared to the control     group. Our main objective is increase in activity time.   "
196634|NCT00424931|"     The purpose of this study is to evaluate the safety and effectiveness of JNJ-17216498     compared to modafinil and placebo in patients with narcolepsy, with and without cataplexy.   "
196637|NCT00424970|"     The prevalence of High Altitude Polycythemia (or Chronic Mountain Sickness) is between 8 and     15% in the high altitude regions of South America. There is no pharmacological treatment     available. After a first preliminary study in 2003 demonstrating the beneficial effects of     acetazolamide in reducing hematocrit in these patients, after 3 weeks of treatment, we want     to confirm this effect and implement a treatment protocol of 3 month-duration.   "
196638|NCT00424983|"     The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK)     profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients     treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.   "
196639|NCT00424996|"     Glaucoma is a chronic disease defined by characteristic changes in the optic nerve associated     initially with loss of peripheral vision and is treated by lowering intraocular (inside the     eye) pressure. It has been reported that noticeable changes to the optic nerve caused by     glaucoma may occur several years before changes in vision are noticed. Since changes to the     optic nerve and other eye structures due to glaucoma are irreversible, it is important to     develop tools for the earliest possible detection of changes due to glaucoma.      The Heidelberg Retina Tomograph (HRT) is a device that is used to produce a three-dimensional     map of the optic nerve and retina, and can be used to detect changes in the optic nerve and     retina over time. In previous studies, it has been shown to be useful for the detection of     changes due to glaucoma. However, the HRT when compared to other techniques to evaluate the     optic nerve such as stereophotography, was found to only somewhat agree.      The current study will compare HRT to stereophotography to determine how good each one is at     looking and documenting changes in the optic nerve over time due to glaucoma. Using HRT to     initiate early topical medication or to change management requires knowing how well HRT     results predict the development of visual loss. Accordingly, the results of this study may     affect the management of glaucoma patients by optimizing the follow-up of people with this     condition and by initiating appropriate and more individualized treatments. Early treatment     is crucial for preventing further visual loss in patients with glaucoma or ocular     hypertension (high pressure inside the eye).   "
196640|NCT00425009|"     The purpose of this study is to determine whether berberine is effective in the treatment of     type 2 diabetes.   "
196641|NCT00425022|"     To examine the feasibility of VATS lobectomy for clinical stage IB or II non-small cell lung     cancer. Success is defined as VATS lobectomy without conversion. If success rate over 90%,     VATS lobectomy is considered as feasible procedures for clinical stage IB or II non-small     cell lung cancer   "
196642|NCT00425035|"     Multicenter, 2-part, multiple-dose study designed to evaluate the safety and effectiveness of     weekly administration of panitumumab in subjects with renal carcinoma. Part 1 was initiated     in 2001 and will not be presented here. Part 2 was designed to examine a dose of 2.5 mg/kg/wk     in 2 cohorts.   "
196643|NCT00425048|"     Unconscious touching of a person's own head or neck (for example by scratching) is a     frequently observed and completely normal physiological movement pattern in humans, which     when done by medical personnel attending a patient poses a high risk of unconscious     self-contamination, even of an already disinfected hand, and of subsequent contamination of     the patient. However, as compared to an ungloved hand, a gloved hand is felt to be foreign,     which could reduce the frequency of self-contact and thus the contamination rate.      Wearing protective gloves is highly recommended in medical practice. The purpose of this     study is to explore how wearing, or not wearing, protective gloves affects        -  the frequency of unconscious self-contact        -  contamination of the gloved/ungloved hand   "
196644|NCT00425061|"     Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with     persistent asthma.   "
196645|NCT00425074|"     The purpose of this study is to evaluate the platelet antiaggregant effect that a chronic     treatment with ASA (150 mg) produces,comparing this effect between two formulations of ASA:     normal and the one of sustained release, in patients with stable coronary disease.   "
196646|NCT00425100|"     To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB)     symptom relief in OAB patients who were dissatisfied with their prior therapy with     tolterodine.   "
196647|NCT00425113|"     This study will evaluate the effect of adding metronidazole to standard second-line therapy     for tuberculosis in patients who have multi-drug resistant tuberculosis (MDR-TB) of the     lungs. It will evaluate the safety and tolerability of metronidazole in combination with     antituberculosis agents. Metronidazole is a drug widely used to treat bacterial and parasitic     infections occurring in environments with very little oxygen such as the human colon. Nine     million new cases of sputum-positive tuberculosis are diagnosed worldwide each year.      Patients ages 20 and older who have symptoms of TB, who have been treated for tuberculosis     but whose disease is multi-drug resistant, and who are not pregnant or breast feeding may be     eligible for this study. They will be recruited in the National Masan Tuberculosis Hospital     (NMTH), Masan, Republic of Korea. Patients will undergo the following tests and procedures:        -  Collection of sputum for counting of bacteria.        -  Drawing of blood for routine blood chemistry analysis; for measuring levels of          metronidazole; TB lipid analysis; and for testing levels of T-cells, which are part of          an immune response.        -  Two targeted positron emission tomography (PET) scans, each with a computed tomography          (CT) scan, and five high-resolution CT scans.      Patients will receive either an 8-week course of standard second-line agents plus placebo     (sugar pill) or an 8-week course of standard agents plus metronidazole. The subjects, doctors     and researchers will not know which patients are taking the metronidazole until after the     first 2 years of the trial. A total of 60 patients will be assigned to two cohorts of 30     patients each. After 8 weeks, all patients will return to the standard of care chemotherapy,     according to normal procedures at NMTH.      Side effects of metronidazole commonly reported are vaginal discharge, symptoms of Candida     cervicitis and vaginitis, headache, nausea and vomiting, and dizziness. Peripheral     neuropathy, an abnormal condition of the nerves, may also be a side effect. The precise     incidence of neuropathy is unknown but is usually related to the duration of metronidazole     use. It can almost always be reversed when the drug is discontinued. Serious side effects,     though rare, may include leukopenia and thrombocytopenia (disorders in the blood), seizures     and other central nervous system problems, and hepatitis.      This study may or may not have a direct benefit for participants. However, it is possible     that patients' drug-resistant disease may be more effectively treated as a result of     metronidazole. The study may help identify new methods for measuring drug effectiveness     during TB studies.   "
196648|NCT00425126|"     Delayed graft function (DGF) is a major complication following deceased donor renal     transplantation. The surgical procedure of harvesting a kidney from a cadaveric donor and     implanting the kidney into the recipient inevitably causes some amount of injury. While not     always clinically significant, anywhere from 10-50% of transplant patients may develop DGF.     Ongoing research in animal models has demonstrated benefit with administration of     erythropoietin. The investigators propose to study the effect of Procrit(Epoetin Alfa) on     delayed graft function in subjects undergoing kidney transplantation.   "
196650|NCT00425152|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Leucovorin may help fluorouracil kill more tumor cells. Biological therapies, such as     levamisole, may interfere with the growth of tumor cells and slow the growth of solid tumors.     It is not yet known whether fluorouracil is more effective when given together with     leucovorin and/or levamisole after surgery in treating colon cancer.      PURPOSE: This randomized phase III trial is studying giving fluorouracil together with     leucovorin to see how well it works compared with giving fluorouracil together with     levamisole, or giving fluorouracil together with leucovorin and levamisole after surgery in     treating patients with Dukes' B or Dukes' C colon cancer.   "
196651|NCT00425165|"     The purpose of this trial is to evaluate the effects of a single dose of denufosol versus     placebo on mucociliary clearance in patients with mild to moderate CF lung disease   "
196652|NCT00425178|"     FGF-1 is being used for the treatment of patients with diabetic or venous stasis ulcers.     Procedure includes topical administration of FGF-1 or placebo and evaluation of safety,     pharmacokinetics, and wound improvement.   "
196653|NCT00425191|"     To assess the antitumour activity (response rate) in patients with locally advanced or     metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and     gemcitabine and of a sequential treatment of cisplatin /gemcitabine followed by docetaxel as     first line chemotherapy · To evaluate the quantitative and qualitative toxicity of each     treatment arms.· To determine time to progression, duration of response, time to treatment     failure, and overall survival in each group.· To evaluate changes from baseline in the Lung     Cancer Symptom Scale of patients in each treatment arm.   "
196654|NCT00425204|"     A multi-center, open-label, extended treatment, clinical trial examining the safety of     administering multiple does of panitumumab by intravenous (i.v.) infusion to patients who     have previously received panitumumab and benefited from treatment   "
196668|NCT00425386|"     RATIONALE: Sunitinib and erlotinib may stop the growth of tumor cell by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib     together with erlotinib may kill more tumor cells.      PURPOSE: This phase II trial is studying the best dose of erlotinib when given together with     sunitinib and to see how well they work in treating patients with unresectable or metastatic     kidney cancer.   "
196777|NCT00416559|"     RATIONALE: Observation is closely monitoring a patient's condition and not giving treatment     until symptoms appear or change. Observation may help doctors see how effective surgery is in     treating neuroblastoma.      PURPOSE: This phase II trial is studying how well surgery alone works in treating young     patients with localized neuroblastoma.   "
196655|NCT00425217|"     Membranous glomerulopathy (MN) is a common immune-mediated glomerular disease and the leading     cause of nephrotic syndrome in Caucasian adults. 1 Because of its frequency, it remains the     second or third cause of end-stage renal disease caused by a primary glomerulonephritis. 2 At     presentation, 70% to 80% of patients have the nephrotic syndrome. 1, 3, 4 Proteinuria greater     than 2.0 grams per day is found in > 80% of patients at presentation, with greater than 10     grams found in as many as 30%. 5 The disease affects patients of all ages, but it is most     often diagnosed in middle age with the peak incidence during the fourth and fifth decades of     life. There is close to a two-to-one predominance of males to females diagnosed with the     disease. Idiopathic MN affects all races. Current therapeutic options include corticosteroids     alone or in combination with alkylating agents, cyclosporin A, and mycophenolate mofetil. The     most widely recognized, and best-validated regimen is combination therapy with     corticosteroids and an alkylating agent, but its use is associated with significant adverse     effects. Recent meta-analysis confirmed that present day treatments are far from ideal 6     Thus, it should not come as a surprise that the outcome of MN has not substantially improved     over the past 30 years, and up to 40% of patients still progress to end-stage renal failure.     7 Like in other glomerular diseases the amount of protein in the urine correlates well with     long term prognosis. Thus, this parameter has been used in previous studies, and will be used     in this study, as the primary indicator of effectiveness of therapy. We proposed to do a     pilot study to test the hypothesis that selective B lymphocyte depletion will result in     disappearance of pathogenic antibodies and induction of remission of the nephrotic syndrome     in patients with idiopathic membranous nephropathy. Our population will be 10 adults. The     study will be conducted between our Nephrology Divisions at Mayo Clinic Rochester,     Jacksonville, and Scottsdale. We will enroll patients with a GFR 25 ml/min as estimated by     creatinine clearance and proteinuria > 4g/24h, while receiving an ACEI or ARB and with BP     controlled of < 130/80 mmHg. Patients will receive Rituximab 1g on Day 1 and 15. Patients     followed for 1 years following completion of treatment. The primary outcome will be change in     urinary protein excretion at 6 months. Secondary outcomes will be changes in serum albumin,     serum lipid?s profile, the number of partial remissions, time to remission, and incidence of     relapses. We will also perform a pharmacokinetic study to evaluate the effect of proteinuria     on the bio-availability and effects of the drug.   "
196656|NCT00425230|"     This is a study to assess the possible benefit of duloxetine in the treatment of chronic     phantom limb pain.   "
196657|NCT00425243|"     The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5     mg in comparison with placebo, when administered over a long-term period, on an as needed     basis, in patients with chronic primary insomnia.      Secondary objectives of the study are to evaluate the drug taking behavior over a long-term     period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to     placebo administered over a long-term period, on an as needed basis.   "
196658|NCT00425256|"     This 8 week at home study is designed to explore efficacy endpoints and evaluate the safety     of intranasal Bremelanotide in women with Female Sexual Arousal Disorder. Efficacy will be     assessed vs. a parallel placebo group.   "
196659|NCT00425269|"     Immigrants from South Asia in Norway have a high prevalence of type 2 diabetes and conditions     related to the metabolic syndrome. It has been documented that these conditions may be     prevented by changes in lifestyle. No previous intervention studies on immigrants with focus     on diet and physical activity have been carried out in Norway. This project concerns a     randomized controlled trial with intervention to change diet and physical activity in 200     high risk female Pakistani immigrants living in Oslo. The intervention will be evaluated both     in terms of outcome and process.   "
196660|NCT00425282|"     The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on     treatment of partial onset seizures.   "
196672|NCT00425451|"     The purpose of this study is to determine the effect of the placement of a PerioChip Plus     (flurbiprofen/chlorhexidine - FBP/CHX) formulation versus PerioChip (chlorhexidine)     formulation versus Flurbiprofen Chip formulation versus Placebo Chip formulation on probing     pocket depth (PPD)   "
196673|NCT00425464|"     The purpose of the study is to determine if the Synchrony Dual Optic Accommodating     Intraocular Lens can be used safely and effectively in post cataract extraction subjects   "
196661|NCT00425295|"     The main purpose of this study is to assess the effectiveness of human simulation in the     training of the leadership, cognitive, and psychomotor skills required to lead medical crisis     management teams. All participants in the study are trainees in the University of Pittsburgh     Medical Center (UPMC) Multi-Disciplinary Critical Care Training Program (MCCTP.) All trainees     will have received the standard critical care medicine-training curriculum including basic     airway management, management of hypotension, unstable cardiac arrhythmias, difficult airway     management and crisis team training. The participants will have also completed six months of     baseline clinical training, which includes responding to medical emergencies at UPMC.      The specific aims of this study are:        1. To assess the effectiveness of Human Simulation Training (HST) as an educational tool          for teaching medical crisis management.        2. To determine the effect of HST on objective measures of performance in the domains of          communication, leadership, cognition and psychomotor skills.   "
196662|NCT00425308|"     Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine     microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate     Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in     study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely     discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine     microemulsion + steroids).   "
196663|NCT00425321|"     The primary objective of the study is to evaluate the safety and tolerability of 100, 200,     and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with active Rheumatoid     Arthritis despite methotrexate therapy.   "
196664|NCT00425334|"     This is a progressive dose escalation study designed to evaluate the safety of Hemospan     compared to a standard crystalloid solution (Ringer's lactate) in elective surgery patients     undergoing total prostatectomy procedures with anticipated blood loss of more than 500 mL.     Secondary objectives of this study are to observe possible activity of Hemospan for tissue     oxygenation, perfusion and cardiovascular support.   "
196665|NCT00425347|"     To identify the MTD of HuLuc63 administered intravenously (IV) for 4 doses.2. To evaluate the     safety of HuLuc63 IV given every other week for 4 doses.   "
196666|NCT00425360|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Vaccines made from peptides may help the body build an effective immune     response to kill tumor cells. Giving more than one drug (combination chemotherapy) together     with vaccine therapy may kill more tumor cells. It is not yet known whether chemotherapy is     more effective with or without vaccine therapy in treating pancreatic cancer.      PURPOSE: This randomized phase III trial is studying gemcitabine, capecitabine, and vaccine     therapy to see how well they work compared with gemcitabine and capecitabine alone in     treating patients with locally advanced or metastatic pancreatic cancer.   "
196667|NCT00425373|"     The purpose of this study is to evaluate the safety and efficacy of fixed combination of     valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone,     and placebo in reducing blood pressure. The study will investigate the dose response     relationship for the combinations, monotherapies, and placebo.   "
196669|NCT00425399|"     In the current study we will study the effect of adding shiatsu treatment to conventional     therapy in work with hospitalized schizophrenic patients.      The hypotheses of this study are several:        1. Shiatsu can improve the patients' symptoms        2. Shiatsu can ameliorate neuromuscular side effects produced by standard anti-psychotic          treatment        3. Shiatsu can provide patients with tools to deal with the stresses of their illness      2. Methodology We propose an open pilot study in which a total of 20 patients of both sexes     will be enrolled. These patients will be drawn from the inpatient psychiatric wards at Herzog     Hospital.      Upon inclusion into the trial, all participants will receive shiatsu treatment, consisting of     two individual weekly 40-minute shiatsu treatment sessions for four weeks. Provider and     patient will be of the same gender. Standard pharmacotherapy will be provided as needed     during the treatment period. Medication and dosage will not be changed. If necessary,     benzodiazepines will be administered as required.      Outcome measures:      The following assessments will be included:        1. Medication: Use of SOS benzodiazepines        2. Clinical rating scales: PANSS, CGI, NOSIE, Hamilton Scales for depression and anxiety      1. Side effect scales: Simpson Angus Scale, AIMS scale, UKU scale 2. Neurophysiological     testing: Prepulse inhibition (PPI). 3. Neurocognitive testing: This will be performed using     the NIMH's Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)     Consensus Cognitive Battery for Clinical Trials.   "
196670|NCT00425425|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Cetuximab may also make tumor cells     more sensitive to radiation therapy. Drugs used in chemotherapy, such as oxaliplatin and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     tumor cells. Giving cetuximab, chemotherapy, and radiation therapy before surgery may make     the tumor smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin and     fluorouracil when given together with cetuximab and radiation therapy and to see how well     they work in treating patients with stage II or stage III esophageal cancer.   "
196671|NCT00425438|"     This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids,     versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine     in the maintenance phase, in maintaining remission and renal function in patients with lupus     nephritis. Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for     24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks,     or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by     azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. Response rate     will be assessed at the end of the induction phase, and at the end of study. The anticipated     time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
196674|NCT00425477|"     RATIONALE: Bexarotene may help cancer or abnormal cells become more like normal cells, and to     grow and spread more slowly. Colony-stimulating factors, such as GM-CSF, may increase the     number of immune cells found in bone marrow or peripheral blood. Giving bexarotene together     with GM-CSF may be an effective treatment for myelodysplastic syndrome (MDS) or acute myeloid     leukemia.      PURPOSE: This phase II trial is studying how well giving bexarotene together with GM-CSF     works in treating patients with MDS or acute myeloid leukemia.   "
196675|NCT00425490|"     The study is designed to investigate the effect of 18 weeks treatment with Sitagliptin 100     mg/day on the insulin secretion capacity of beta cells.      Patients who meet the study enrollment criteria will undergo 2 experiments (see description     below); a graded hyperglycemic technique and a meal test, prior to randomization and after a     12-wk double-blind study period. The treatment effect will shed light on the magnitude of the     beta cell capacity to increase its mass and function.   "
196676|NCT00425503|"     Following pretreatment evaluation, patients receive PS-341 by intravenous push weekly for 4     consecutive weeks followed by a 24-72 hour rest period. This schedule consists of one     treatment cycle. Upon the completion of 4 weeks of PS-341 followed by a 24-72 hour rest     period, radical prostatectomy will be performed. Surgery will be delayed if there is any     bleeding abnormality (bleeding time greater than 10 minutes) and until platelet count is more     than or equal to 100,000 and coagulation profile (PT, PTT) is normal. If at the time of     surgery a patient is found to have positive lymph nodes, prostatectomy will be abandoned, the     prostate will be biopsied, and the patient will be offered other treatment modalities     (hormones, radiation therapy).   "
196693|NCT00425724|"     No curative treatment of severe HSP nephritis is known.      Apart from corticosteroids, immunosuppressive drugs, such as azathioprine and     cyclophosphamide, have been used to treat severe HSP nephritis.Limited patient series treated     with these drugs have been described, but there are no reports of controlled trials.      Cyclosporine A have been used to treat corticosteroid-resistant or corticosteroid-dependent     nephrosis. (11) Cyclosporine A has also been used to treat HSP nephritis, but as far as we     know, there are no publications reporting such trials.      The aim of the study is to compare MP pulses and cyclosporine A for their efficacy in the     treatment of HSP nephritis.      The efficacy of the two treatments will be assessed on the basis of the duration of     nephrosis/nephritis, the maintenance of renal function and the renal biopsy findings.   "
196694|NCT00425737|"     To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine     (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with     human rotavirus   "
196808|NCT00416975|"     RATIONALE: Education, based on a patient's risk factors, may help promote breast cancer     screening in healthy women.      PURPOSE: This randomized clinical trial is studying individualized risk-based education to     see how well it promotes breast cancer screening in healthy women compared to standard     education.   "
196677|NCT00425516|"     Neoadjuvant chemotherapy, known as first or induction chemotherapy in the therapeutic     assumption of breast cancer is based on the narrow dependence preclinically revealed between     primary tumour, tumoral angiogenesis and growth of distant metastases.      The results of the Aberdeen Group (Smith et al, 2002 ; Hutcheon et al, 2003), of the NSABP     B27 trial (Bear et al, 2003) and of the Gepar-Duo Group (Von Minckwitz et al, 2002) have     shown that a sequential protocol, using docetaxel after an anthracycline-based combination,     allowed a better clinical response leading to more frequent conservative surgeries and, more     importantly, to an increase in the rate of complete pathological response, assessing a better     efficacy.      The use of a reference adjuvant protocol as a neo-adjuvant treatment is fully admissible     because 7 randomized trials have shown a perfect equivalence between an adjuvant protocol and     the same chemotherapy given as an induction treatment Even keeping the principle of a     sequential treatment, a crucial question is to know if this sequential treatment should be     the same for all patients, or if the oncologist could get a better complete pathological     response, disease-free or overall survival rates by an adaptation of treatment to the     objective result beginning after 2 FEC 100 courses by modulation of the following courses.      We will use as a primary regimen 3 FEC cycles + 3 TAXOTERE cycles, a standard adjuvant     regimen (noted in the Temporary Protocol of Treatment of the Inca page 5 (October 2005) as     well as in Saint Paul de Vence 2005 recommendations for adjuvant chemotherapy (Oncologie --     volume 7 - N°5, August 2005, p 370). This standard treatment will be compared to the same     chemotherapy modulated in its repartition according to results obtained by subsequent tumor     evaluations during induction therapy.   "
196678|NCT00425529|"     The primary objective of this clinical trial is to test the tolerance and practicality of the     new device Module AOX.      The secondary objective is to determine the changes in oxidative, antioxidative status,     plasma free amino acids, and various immune parameters in critically ill patients receiving     the enteral nutrition with and without using Module AOX.   "
196679|NCT00425542|"     The purpose of this randomized clinical trial is to determine whether outpatient treatment is     as effective and safe as inpatient treatment among low-risk patients with pulmonary embolism.   "
196680|NCT00425555|"     This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory     Cutaneous T-Cell Lymphoma.   "
196681|NCT00425568|"     Low testosterone may be responsible for soft erections in men. The purpose of our study is     to see whether the daily application of a testosterone gel to raise testosterone levels will     also increase the hardness of a man's erection.   "
196682|NCT00425581|"     The primary objective is to test the hypothesis that there is an association between the     hemodynamic status and the serum levels of NT-proBNP and cTnT in prematurely born infants. We     would also evaluate the hypothesis that there is an association between the level of these     proteins in the serum and the short and long term morbidity.   "
196683|NCT00425594|"     This randomized, parallel, multi-center, single-blind study is designed to compare the safety     and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy     for a routinely accepted indication.   "
196684|NCT00425607|"     This is an open label dose adjusted phase II trial of the oral farnesyltransferase inhibitor     (FTI) lonafarnib (SCH66336) for patients with HGPS and progeroid laminopathies.   "
200993|NCT00471874|"     The purpose of this study is to determine in Australia what effect rheumatoid arthritis has     on quality of life, and also to determine the costs that are associated with having     rheumatoid arthritis.   "
196685|NCT00425620|"     The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B     suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during     16 weeks of treatment in patients with refractory, postsurgical CS.   "
196686|NCT00425633|"     The purpose of this study is to find out whether homeopathic potassium dichromate will     decrease the time on the breathing machine and the amount of phlegm that you produce in your     lungs. In addition, this study will look at whether participants spend less time in a     critical care unit and if the chances of being placed back on a breathing machine can be     lessened.   "
196687|NCT00425646|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Imatinib     mesylate and bevacizumab may also stop the growth of tumor cells by blocking blood flow to     the tumor. Giving imatinib mesylate together with bevacizumab as maintenance therapy may stop     non-small cell lung cancer from growing or coming back.      PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with     bevacizumab after first-line chemotherapy and bevacizumab works in treating patients with     stage IIIB or stage IV non-small cell lung cancer.   "
196688|NCT00425659|"     Newer home sleep study device and algorithm provides an alternative for inpatient sleep study     and improve the service provides to patients   "
196689|NCT00425672|"     RATIONALE: ONTAK may be able to help reduce the type of cells that prevent other types of     immune cells from attacking the breast cancer cells.      PURPOSE: This phase I/II trial is studying the safety of ONTAK and its possible side effects     to see how well it works in treating patients with advanced breast cancer that did not     respond to previous treatment.   "
196690|NCT00425685|"     ECMO offers an acceptable cardiopulmonary support in adults with similar hospital survival     rates as other mechanical support. It is versatile and salvages some patients, who may     otherwise die. Improvement in intermediate term outcome will require multidisciplinary     approach to protect organ function and limit organ injury during this support.   "
196691|NCT00425698|"     The hematopoetic cytokine erythropoietin (EPO) has been shown to reduce programmed cell death     and tissue destruction in experimental models of acute kidney ischemia-reperfusion injury.     Thus, treatment with high dose recombinant human EPO (rHuEPO) may prevent kidney tissue     damage and loss of renal function after successful kidney transplantation in humans.   "
196692|NCT00425711|"     Acamprosate will be given to approximately 30 DUI Court participants for 3 months and     outcomes will be monitored. The hypothesis is that acamprosate will be safe and     well-tolerated and that subjects' craving and other symptoms related to addiction will     improve over time.   "
196720|NCT00426101|"     Without therapy HLH is often fatal, and often rapidly fatal. The treatment protocol HLH-94     has improved survival markedly as compared to the survival earlier. We now aim to improve     survival further.   "
196695|NCT00425750|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It may also stop the growth of tumor cells by blocking blood flow to     the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     bortezomib together with docetaxel may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with docetaxel     works in treating patients with recurrent or metastatic head and neck cancer.   "
196696|NCT00425763|"     We will be studying the clinical efficacy of amodiaquine-artesunate currently being studied     in an intermittent preventive therapy in infants (IPTi)trial in the same area in order to     correlate preventive efficacy seen in IPTi with efficacy for treatment of symptomatic malaria     for each regimen.   "
196697|NCT00425776|"     In a randomized 3-group clinical study acupuncture is used for the relief of menopausal hot     flushes and sleep disturbances in women treated for breastcancer.      The three groups consists of 35 women given acupuncture once a week five times and 35 women     given shamacupuncture once a week five times and 35 women with no kind of treatment.     Se-estradiol and endorphin is measured before and after the acupuncture.      We want to state that acupuncture given five times once a week has a significant better     effect on hot flushes and sleeping disturbances than shamacupuncture or no treatment at all.      We also want to measure if there are any changes in se-estradiol and endorphine   "
196698|NCT00425789|"     To evaluate whether treatment with Hyperbaric oxygen can accelerate skin recovery after deep     peeling, and decrease frequency and severity of local side effects and complications.      20 post peel patients will recieve 5 daily hyperbaric treatments, starting from day 7 to     peel.Patient's followup will include self- filling questionnaire and photographs   "
196699|NCT00425802|"     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor stem     cell transplant helps stop the growth of cancer cells. It also helps stop the patient's     immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as     rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to     them without harming normal cells. The donated stem cells may replace the patient's immune     cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving rituximab before transplant and cyclosporine and mycophenolate mofetil after     transplant may stop this from happening.      PURPOSE: This phase II trial is studying the side effects and how well giving chemotherapy     and radiation therapy together with rituximab and donor stem cell transplant works in     treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.   "
196710|NCT00425958|"     The purpose of this research is to find whether or not there are differences in the executive     functions during shopping in a virtual mall, between children with Acquired Brain Injury     (ABI) vs healthy children.      The hypothesis is that there will be differences in time (more time to shop) and mistakes     (more mistakes during shopping), in the ABI group.   "
196823|NCT00417170|"     The purpose of this study was to determine the effects of Aliskiren on insulin resistance     (IR) and endothelial dysfunction (ED) in patients with high blood pressure and metabolic     syndrome. The efficacy of Aliskiren was compared to Amlodipine.   "
196700|NCT00425815|"     The TURNS is a National Institute of Mental Health (NIMH) funded contract for the evaluation     of new compounds for the treatment of cognitive impairments in schizophrenia (HHSN 27820044     1003C; P.I.: Steve Marder, M.D.). Despite advances in the safety, tolerability, and     effectiveness of antipsychotic medications for the treatment of schizophrenia, many patients     continue to be plagued by impairments in social and work functioning. Persons with     schizophrenia commonly show deficits in a number of areas of cognition that include     impairments in attention, memory, and executive functioning (the ability and organize one's     behavior). Importantly, a large body of literature now shows a link between cognition and     community functioning in schizophrenia. It is believed that treatments that improve cognitive     deficits may lead to improvements in work and social functioning.      A promising approach to improve the community functioning of patients with schizophrenia is     to develop new agents that treat the cognitive deficits of the illness. One type of     pharmacological compound that has shown promise at improving cognition is a group of drugs     called ampakines. These drugs are believed to improve the activity of a neurotransmitter     system in the brain called the glutamate system. Increased activity of this system has been     linked to improvements in cognitive functioning. The current study is an eight-week trial     comparing two doses of the ampakine drug, Org 24448, that will be added to patients' current     atypical antipsychotic medication. One hundred thirty-five patients with schizophrenia, drawn     from seven sites, will participate in the study. Cognition will be measured using a variety     of paper-and-pencil and computerized measures from the consensus-derived NIMH Measurement and     Treatment Research to Improve Cognition in Schizophrenia (MATRICS) cognitive battery.     Psychiatric symptoms and the ability to perform community-based tasks of daily living will     also be measured. Because previous trials with this drug and other similar drugs have     detected lasting cognitive benefits, this trial will also repeat clinical assessments four     weeks after completion of the study medication.   "
196701|NCT00425841|"     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor     and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine and     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving stereotactic radiation therapy together with     combination chemotherapy before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed. Giving combination chemotherapy after surgery may     kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving stereotactic radiation therapy     together with combination chemotherapy works in treating patients undergoing surgery for     locally advanced pancreatic cancer.   "
196702|NCT00425854|"     The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW     2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with     HER2-negative breast cancer after failure of no more than three regimen of prior     chemotherapy.   "
196703|NCT00425867|"     The present study will be undertaken to establish whether genetic variations of PAR1 could be     involved in the occurrence of any of the placental syndromes of preterm delivery,     preeclampsia, and/or small for gestational age babies and recurrent pregnancy loss.   "
196721|NCT00426114|"     Patients with peritoneal dialysis will be administered an IV glucose-injection to evaluate     the haemodynamic impact of this injection. The patients will be matched with healthy     volunteers.   "
196722|NCT00426127|"     The purpose of this study is to assess the effects of the treatment combination of the     commercially available chemotherapy drugs, docetaxel and liposomal doxorubicin, and a blood     thinner Enoxaparin on pancreatic cancer. The main goal of the study is to find out if this     combination chemotherapy and enoxaparin increases the number of individuals whose tumors     shrink.   "
196723|NCT00426140|"     The main purpose of this study is to characterize the distribution, metabolism, and     elimination (ADME) of Patupilone after a single intravenous administration in patients with     advanced solid tumor malignancies   "
196778|NCT00416572|"     RATIONALE: Educational programs may improve coping and quality of life in younger women who     have recently been treated for early-stage breast cancer.      PURPOSE: To conduct a clinical trial to determine if an educational intervention and a     nutritional intervention could enhance physical and psychological functioning among younger     women completing treatment for early-stage breast cancer.   "
196704|NCT00425880|"     Asthma and smoking during pregnancy cause significant morbidity in both the mother and the     offspring. Asthma represents the most common respiratory disorder during pregnancy and     smoking rates during pregnancy range from 15-30% in the United States. Maternal asthma and     smoking during pregnancy have been shown to increase the rate of intrauterine growth     retardation and preterm delivery, as well as increase the risk of wheeze, asthma, respiratory     infections, and otitis media in children. However, controlled asthmatics during pregnancy     have similar pregnancy outcomes to non-asthmatic pregnancies. Measurement of the fractional     concentration of exhaled nitric oxide (FENO) is a new, easily performed, non-invasive method     that has been used to assess airway inflammation in adults and children. The long term goal     of this study is to establish baseline FENO values and to monitor airway disease in pregnant     asthmatics, pregnant smokers and pregnant controls, and to correlate these levels with other     inflammatory markers in the mothers and their offspring. These values will be correlated with     current methods to diagnose and monitor disease control in these patients. The use of FENO     levels in the pregnant asthmatic may prove to be a better method for monitoring disease     control and titrating steroid doses in this population. Finally, this study may identify     children at higher risk of developing asthma or allergic disease. This could serve to     identify factors that may be modified to prevent or limit the development of these diseases     in this population.   "
196705|NCT00425893|"     This study will test the effectiveness of face masks and hand cleaning in preventing the     spread of influenza within households   "
196706|NCT00425906|"     RATIONALE: The use of a nicotine inhaler may help decrease appetite and relieve hunger pain     (an intense craving for food) in patients with malignant bowel obstruction caused by cancer.      PURPOSE: This randomized clinical trial is studying the side effects and how well a nicotine     inhaler works in treating hunger pain in patients with malignant bowel obstruction caused     by cancer.   "
196707|NCT00425919|"     The purpose of this study is to learn whether PPM-204 has an effect on lowering blood glucose     (blood sugar) levels and is safe in treating people with type 2 diabetes.   "
196708|NCT00425932|"     The purpose of this study is to further investigate rituximab in the treatment of rheumatoid     arthritis and to evaluate magnetic resonance imaging of the joints as a possible method to     improve the evaluation of treatments.   "
196709|NCT00425945|"     The purpose of this study is to investigate the efficacy of Flavangenol® (Toyo Shinyaku,     Japan), a pine bark extract, in lowering blood pressure and improving glycemic control and     plasma lipoprotein profile.   "
196884|NCT00417963|"     To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire     Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery     stenosis in patients at high risk for carotid endarterectomy.   "
196711|NCT00425971|"     BMEC-1217B is an abbreviated version of an old Chinese formulation. The ratio of each     component was adopted by the sponsor following the observation that BMEC-1217B prepared from     this ratio resulted in best pharmacological profile and in vitro bioactivities.      BMEC-1217B was studied for the pharmacological activity on the release of cysteinyl     leukotrienes, IL-4 and TNF-alpha in vitro and the airway hyperreactivity. The result     indicated that BMEC-1217B can inhibit the synthesis of several key pro-inflammatory mediators     involved in the pathophysiology of allergic asthma and can also improve lung function in a     mouse model of allergic asthma.      The purpose of this study is to evaluate the safety and tolerability of increasing dose of     BMEC-1217B when administered orally in healthy volunteers.   "
196712|NCT00425984|"     Circumcision in HIV unifected men may reduce the likelihood of becoming infected with HIV,     reduce sexually transmitted infections (STIs) in men, not engender increases in sexual risk     behaviors, and be acceptable to men as a procedure for preventing HIV. The purpose of this     study is to evaluate circumcision in HIV uninfected men in terms of safety and ability to     prevent HIV infection.   "
196713|NCT00425997|"     This study will evaluate the efficacy of valsartan/hydrochlorothiazide versus amlodipine and     hydrochlorothiazide in patients with Stage 2 hypertension using 24-hr ambulatory blood     pressure monitoring (ABPM)   "
196714|NCT00426010|"     We propose to measure the effect of placebo by elimination as well as by a balanced placebo     design, determine its interaction with active drug, and explore whether placebo exerts part     of its effect at the pharmacokinetics level.   "
196715|NCT00426023|"     This interventional study aims to evaluate the efficacy of Cyclosporine eye drop treatment in     preventing relapses of Vernal Keratoconjunctivitis (VKC) and in treating the acute phases of     the disease.   "
196716|NCT00426036|"     This study will assess the influence of severe renal impairment on the pharmacokinetics of     licarbazepine and its glucuronide conjugate after single oral administration in healthy     subjects and in subjects with stable impaired renal function.   "
196717|NCT00426049|"     The purpose of the present study is to provide the first in-human safety and efficacy     evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in     patients treated by bare metal stents for significant coronary artery disease. The aim is to     reduce Major Adverse Cardiac Events (MACEs) including death, coronary artery bypass grafting     (CABG) to the target vessel, Q-wave and non-Q-wave myocardial infarction, and target lesion     revascularization within the first 6 months after intervention. Additionally safety and     tolerability of Everolimus at the selected dose in this patient population will be analyzed.   "
196718|NCT00426062|"     Study comparing level of free radicals in tumor tissue, blood serum and saliva in patients     with Squamous Cell Carcinoma of tongue and mouth floor. Patients with benign fibroma of oral     cavity and normal gingiva around extracted lower wisdom tooth are used for control   "
196719|NCT00426075|"     Prospective controlled randomized clinical trial. Consecutive patients with acute proximal     deep vein thrombosis of the lower extremities, with or without contemporary manifestations of     pulmonary embolism, are randomized to receive either a below-knee or a full-leg graduated     compression (30-40 mm Hg at the ankle) elastic stocking for prevention of the post-thrombotic     syndrome (PTS). All patients are followed up to three years to assess the development of the     PTS, defined according to a validated clinical score (the Villalta scale). The rate of PTS is     compared between the two study groups. In addition, there is an assessment of patients'     compliance and tolerability of the two different devices.   "
196724|NCT00426153|"     This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with     severe polycystic liver disease who are not candidates or decline surgical treatments such as     liver cyst fenestration, liver resection or liver transplantation. A total of 42 patients     will be recruited -14 who will receive placebo and 28 the study drug. Preliminary evidence     indicates that this drug is safe and non-toxic in other disease states. Treatment with this     drug holds promise not only for individuals with liver involvement, but also for many more     patients with polycystic kidney disease.   "
196725|NCT00426166|"     The purpose of this study is to examine whether or not Low Level Laser Therapy (LLLT) can     reduce pain and/or improve wound healing in patients with an acute traumatic injury to the     upper extremity (wrist, forearm, or elbow).   "
196726|NCT00426179|"     This study will assess the effects of Imatinib on allergic inflammation following repeated     nasal allergen challenge in subjects with seasonal allergic rhinitis sensitive to Timothy     grass pollen.   "
196727|NCT00426192|"     After cardiac surgery with cardiopulmonar bypass, the LPS-stimulated cytokine response has     been previously shown to be depressed. Therefore, in this trial the hypothesis was tested,     whether simple immunomodulting interventions like the i.v. adminstration of mannitol of     hemofiltration during cardipulmonary bypass can attenuate this immunosuppressing effect.   "
196728|NCT00426205|"     The purpose of this study is to investigate whether the addition of a vaccine after     participants reduced intensity transplant will be safe and beneficial. The vaccine used in     this trial, called GVAX, will be made from the participants own leukemia cells, and will be     given between 1-4 months after transplant. In recent years, researchers have discovered that     GVAX vaccine made from the patient's own cancer calls that have been engineered in the     laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful     immune response specific to that cancer.   "
196729|NCT00426218|"     This study is a multi-center, open label, repeated dose, range finding study to evaluate the     safety, tolerability, immunogenicity, pharmacokinetics and efficacy of ACZ885, a fully human     anti-interleukin-1B (anti-IL-1B) monoclonal antibody, given subcutaneously in pediatric     subjects with active SJIA.   "
196780|NCT00416598|"     This phase II trial is studying the side effects and how well decitabine works when given as     maintenance therapy after standard therapy in treating patients with previously untreated     acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin,     etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving decitabine as     maintenance therapy after standard therapy may keep cancer cells from coming back.   "
196781|NCT00416611|"     The objective of this protocol is to improve awareness, treatment, and control of arterial     hypertension, within primary prevention of target organ damage, by implementing guidelines,     after training of the participating physicians.   "
196730|NCT00426231|"     Our research aims to improve the use of medicines known to prevent recurrent heart attacks.     In particular, we know that statin treatment is useful after heart attacks, but many patients     do not use it. There are a few possible reasons for this. Patients cannot find affordable     medicine. Their doctor may not prescribe the medicine after they leave the hospital. Some     people may culturally mistrust using the medicine. So they may decide not to take it even if     it is prescribed. We are developing a hospital based culturally attuned program to target     this problem. In this program, a community health worker counsels and helps patients in     accessing pharmacy assistance programs. We will test whether this program can improve     appropriate statin use.      We will enroll patients who have heart attacks. We will compare patients who are counseled by     the community health worker with those who get the usual care at baseline and at 6 and 12     months (participants enrolled during the early phase of the recruitment will have an     additional study visit at 24 months). We will test if their bad cholesterol levels are     controlled. We will find out how regularly they have filled their questionnaire and taken the     medicine. Finally, we will test if they are getting benefit from the statin treatment. We     will do this using blood tests and imaging the patients' arteries with ultrasound. We will     also measure how cost-effective it is for a hospital to run the program.      It is our goal to develop a community health worker model that is culturally sensitive for     people with cultural, educational or educational barriers. Statin use is known to benefit     patients in theory; such a culturally competent program will improve health outcomes in     practice. After we test it, a cost-effective program such as this can be implemented in other     hospitals.   "
196731|NCT00426244|"     The purpose of this study is to determine to what extent and by what physiological mechanisms     Osteopathic Manipulative Medicine (OMM) affects selected conditions related to pregnancy,     labor and delivery.   "
196732|NCT00426257|"     This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal     chemotherapy to secondary debulking surgery in stage III ovarian cancer.   "
196733|NCT00426270|"     Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for     intravenous administration. Octagam 5% is currently registered in about 80 countries. This     study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura     (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that     Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.   "
196734|NCT00426283|"     The purpose of this study is to test the effects (both good and bad) of swallowed fluticasone     propionate (Flovent), in subjects with eosinophilic esophagitis (EE).   "
196735|NCT00426296|"     SHARE: Simple HAART with Abacavir, Reyataz, and Epivir   "
196736|NCT00426322|"     The aim of this clinical study is to compare the amount of newly formed bone after bone     augmentation with Bio-Oss® (BO) 0.25-1 mm vs. Bio-Oss® (BO) 1-2 mm in the sinus floor     augmentation procedure bilaterally in 8 patients.      Hypothesis:      There is no difference in the relative amount of newly formed bone plus BO between the large     (1-2 mm) and small (0.25 - 1 mm) granules.   "
196737|NCT00426335|"     The purpose of this study is to examine whether a group CBT intervention is effective in     reducing psychological distress in women with primary breast cancer.   "
196738|NCT00426348|"     a statement of the study hypothesis:the effect of valsartan in patients with IgA nephropathy     have been proved,and the efficacy of probucol in combination with valsartan is to be proved     in patients with IgA nephropathy.      This is a prospective randomized controlled, double blinded pilot study to identify the     efficacy of probucol in combination with valsartan in patients with IgA nephropathy. The     renal function deterioration will be the primary outcome studied. The expected study duration     will be 36 months.   "
196748|NCT00426491|"     The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle     and Co., Chicago, IL) for the management of non-viable first trimester pregnancies.     Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant     management in who have documented non-viable gestations. We will examine the following     outcome variables: time to resolution, number of patients requiring dilation and curettage,     change in hematocrit, cost to the institution, patient satisfaction, and reported side     effects.   "
196739|NCT00426361|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and     thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical     cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents     platform. Therefore, this Phase IIIb study is designed to evaluate the safety and     immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals'     (580299)HPV-16/18 L1 AS04 vaccine (Cervarix TM) as compared to the administration of either     vaccine alone.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
196740|NCT00426374|"     The purpose of this study is to perform cardiac evaluation in HIV-1 (predominantly clade     C)infected children by history, physical examination, echocardiogram and plasma N-terminal     pro-B-type natriuretic peptide (N-BNP)measurement in order to determine asymptomatic     abnormalities.   "
196741|NCT00426400|"     Our study investigates the effect of anti-aggregative treatment on success and complications     of laser iridectomy. The study includes patients scheduled for laser iridectomy due to narrow     angles.Patients will undergo first laser treatment with the anti-aggregative treatment and     will scheduled for next lase in the other eye after discontinuing the anti-aggregative     treatment. The patients will be followed-up for 3 months.   "
196782|NCT00416624|"     RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells.     They are used to treat anemia caused by chemotherapy in patients with cancer.      PURPOSE: This randomized clinical trial is studying four different schedules of epoetin alfa     or darbepoetin alfa to compare how well they work in treating patients with anemia caused by     chemotherapy.   "
196783|NCT00416637|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others     interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor .      PURPOSE: This phase I trial is studying how well bevacizumab works in treating patients with     advanced solid tumors.   "
196742|NCT00426413|"     Over 50% of obese African-Americans (AA) presenting with newly diagnosed, severe     hyperglycemia and/or unprovoked diabetic ketoacidosis (DKA) display clinical, metabolic, and     immunogenetic features of type 2 diabetes. Prior studies indicate that these patients a) have     markedly decreased insulin secretion and impaired insulin action at presentation, b) absent     or low prevalence of beta-cell autoantibodies and c) are able to discontinue aggressive     insulin therapy in ~70% of cases within 3 months of follow-up. These patients have been     referred to as having ketosis-prone type 2 diabetes (KPDM). Most patients with KPDM, however,     experience a hyperglycemic relapse within a year of insulin discontinuation. Consequently,     patients with KPDM are an ideal model to follow throughout their clinical course. The     specific aims of this proposal are to 1) identify clinical, metabolic, and immunogenetic     markers that alone, or in combination, are predictive of short- and long-term     near-normoglycemic remission and 2) determine whether pioglitazone or sitagliptin therapy     will delay an insulin-deficient relapse once insulin is discontinued. The Principal     Investigator hypothesizes that measures of beta-cell function at presentation, alone or in     combination with measures of insulin sensitivity, will correlate with the ability of a     patient to achieve and remain in near-normoglycemic remission. She also hypothesizes that     intervention compared to placebo will preserve beta-cell function, improve insulin     sensitivity, and prevent an insulin-deficient relapse. This prospective, cohort study with a     RCT arm would better characterize the natural history of KPDM, facilitate the direction of     long-term therapy, and likely decrease the recurrence of DKA which is associated with     increased mortality and morbidity.   "
196743|NCT00426426|"     Meta Cognitive Therapy (MCT) has been introduced as a new specific treatment for generalised     anxiety disorder. So far, no studies have examined CBT and MCT in comparison with each other     in a randomised controlled trial. Sixty patients with a diagnosis of generalised anxiety     disorder will be selected and randomised into three treatment conditions. The first group     (N=20) will be treated with CBT, the second group (N=20) with MCT, and the third condition is     a waiting list control (N=20). The patients in both groups will have full treatment, in     accordance to treatment manuals developed by the originators. Patients in the waiting list     control will be randomly allocated to either CBT or MCT after 12 weeks of waiting period.      The patients will be assessed with the primary measures at pre-treatment, at the end of     treatment, and at follow-up after one and two years. In addition they will be assessed weekly     on symptom measures and worry outcome diary. The therapist will be treating equally amount of     patients in both conditions to control for any biased distribution connected to the     therapist's characteristics.      Measures will be used on at least three main sources; self-report inventories (including     symptom diaries), clinical assessments by independent raters and psycho-physiological     assessments.      We aim to (1) evaluate and compare the effectiveness of CBT and MCT, (2) investigate the     patterns of change and the mechanisms of action involved during treatment in each of the     conditions and, (3) evaluate pre and post-treatment somatic change by psycho-physiological     assessments as a response to CBT and MCT.   "
196744|NCT00426439|"     This study will evaluate the efficacy of treatment with artemether-lumefantrine as compared     to chloroquine in the dose of 50 mg/kg for treatment of malaria in children in Guinea-Bissau.     The genetic basis of the parasites for developing resistance will be examined. Children     coming to one of the Health Centres with symptoms of malaria and a positive malaria test will     be included. The children will be followed weekly until day 70. In case of reappearance of     parasites the child will be re-treated with the opposite study drug.   "
196745|NCT00426452|"     This study will determine the effect of acidic drugs such as proton-pump inhibitors on the     pharmacokinetics of Vatalinib under fasting and fed conditions.   "
196746|NCT00426465|"     This study will explore the optimum training schedule for stroke patients to learn motor     skills. It will see if motor training is more effective when training sessions are     distributed over time (spaced training) or when the sessions are scheduled close together     (massed training). The results of this study may help researchers devise the best training     schedule for patients to derive the maximum benefit from rehabilitation therapy.      Healthy normal volunteers and people who have had a stroke may be eligible for this study.     Patients must be 3 months post-stroke. All participants must be right-handed and between 18     and 80 years of age.      Participants practice a pinch motor task and receive transcranial magnetic stimulation (TMS).     Hand muscle activity is measured using surface electromyography (EMG). Pinch training     involves training the participant to pinch as strongly as possible, using a device that     records the force. For TMS, a wire coil is held on the subject s scalp. A brief electrical     current is passed through the coil, creating a magnetic pulse that stimulates the brain. The     subject hears a click and may feel a pulling sensation on the skin under the coil. There may     be a twitch in the muscles of the face, arm or leg. For surface EMG, electrodes (small metal     disks) are filled with a conductive gel and taped to the skin over the muscle.      Following one practice session of pinch task training and TMS, participants have four     training sessions, which are scheduled 24 hours, 2 weeks, 1 month and 3 months after the     practice session.      For the 4- to 5-hour practice session, subjects do the following:        -  Perform a single session of pinch motor task for familiarization        -  Undergo TMS to measure brain activity        -  Practice five 6-minute blocks of pinch motor task with rest periods between sessions and          perform a calculation task (addition and subtraction tasks) during each rest period        -  Receive TMS over 15 minutes. (Some sessions may have sham TMS.)        -  Read books and magazines during a 45-minute rest period        -  Perform a single block of the pinch motor task        -  Undergo TMS to measure brain activity        -  Complete a questionnaire that measures attention, fatigue and mood      For the remaining four sessions, participants perform one practice block and TMS. Each     session lasts about 2 hours.   "
196747|NCT00426478|"     A double-blind, active-controlled, randomized trial to compare Valsartan plus     Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5 mg.      Study design: 2 weeks washout, 8 weeks treatment period.   "
196749|NCT00426504|"     Historically, patients with stage III and IV head and neck cancer have been treated with     surgery and/or radiation therapy. Based on the results of recent clinical trials, in patients     not able to undergo surgery, chemotherapy with radiation therapy has been adopted as the     current standard of care. The chemo-radiation approach, however, entails a significant     increase in treatment-related toxicity, limiting the extent to which this treatment can be     offered to patients. In this trial, the ability of a new form of radiation therapy delivery     called IMRT will be evaluated for its ability to reduce the amount of radiation-induced     toxicity.   "
196784|NCT00416650|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with     advanced non-small cell lung cancer.   "
196785|NCT00416663|"     Evaluation of an intracoronary injection of ex-vivo generated autologous Angiogenic Cells     Precursors (ACPs) to treat patients suffering from severe angina not responsive to maximal     drug treatment or not willing or without option of undergoing percutaneous coronary     intervention (PCI) or coronary artery bypass graft surgery (CABG). The use of ACPs aims to     promote the formation of new vascularization and thus viable myocardial tissue.   "
196750|NCT00426517|"     This study uses transplantation to treat patients with problems in their immune system. The     immune system cells come from the bone marrow where they grow from special cells called stem     cells. Giving patients stem cells from someone else may help to cure many patients with     certain immune diseases. This is called 'bone marrow transplantation'. This procedure can     have side effects that are life-threatening. To try to make transplantation safer we are     using lower doses of the medications used in preparing the patient for the transplant.      'Conditioning' treatments are given to patients to create space in their bone marrow. This     lets the cells of the donor go into the bone marrow and produce normal immune cells. This     study will use lower doses of a drug called busulfan and lower doses of radiation than what     are currently being used in other kinds of bone marrow transplantation for other diseases.      Another problem that can occur with bone marrow transplantation is 'graft-versus-host     disease'. This happens when the cells of the donor attacks different parts of the patient s     body. This study will use a medicine called sirolimus instead of the usual medicine,     cyclosporine, to prevent graft-versus-host disease.      To go onto this study, you must have:        1. A severe immune deficiency, such as chronic granulomatous disease or leukocyte adhesion          deficiency.        2. Have problems from the disease that call for stem cell transplantation.        3. You must also be between the ages of 3 and 65 years.      Two groups of patients are included in this study:        1. Patients who have a brother or sister that have stem cells that match the patient. This          is known as an allogeneic matched sibling transplant.        2. Patients who do not have a matched sibling donor but have a donor that matches in the          National Marrow Donor Program. This is know as matched unrelated donor transplantation.      Patients will have the following procedures:        -  To create space in the bone marrow, patients are given two drugs, Campath-1H and          busulfan. To prevent the body from getting rid of the donated cells, patients are given          sirolimus. On the day before the BMT, patients in the matched unrelated donor group also          receive a low-dose of whole-body radiation. This will further improve the chances that          the patients body will accept the donor cells.        -  Patients will get the donor stem cells through an intravenous (IV) line that goes into a          vein in their body. The cells make their way to the bone marrow space and slowly refill          the marrow over the next several weeks. Patients will usually stay in the hospital for          30 days after the transplant.        -  For the first 3 months after the transplant, patients are watched closely. The patients          will have frequent visits to the clinic. During these visits the patient will have a          physical examination and blood tests. The doctor and nurse will also check any symptoms          the patient may have. At day 100 after the transplant a sample of bone marrow is taken.        -  Patients will continue to be followed periodically for at least 5 years after the          transplant.   "
196751|NCT00426530|"     This study will look at different dose levels and regimens of everolimus combined with weekly     trastuzumab and vinorelbine therapy in patients with HER-2 overexpressing metastatic breast     cancer.   "
196752|NCT00426543|"     The primary purpose of the study is to determine whether B-cell depletion with Rituximab has     an effect on the oral, ocular and general disease manifestations in patients with primary     Sjögren´s syndrome, that is, an effect on the symptoms of oral and ocular dryness,     improvement of the glandular function and a beneficial effect on the general symptoms such as     fatigue. The secondary purpose of the study is the investigate the underlying autoimmune and     pathophysiological mechanisms in Sjögren´s syndrome.   "
196753|NCT00426556|"     Phase I: will look at different dose levels and regimens of everolimus combined with weekly     trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast     cancer.      Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined     with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing     metastatic breast cancer.   "
196754|NCT00426569|"     The purpose of this study is to check if bacterial and fungal flora exists in healthy     paranasal sinuses, and whether it is identical to the flora of nasal cavity.      We plan to harvest tiny examples of maxillary sinus and nasal mucosa for tissue cultures     during the orthognathic procedures involving maxillary remodeling.   "
196755|NCT00426582|"     This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of     patupilone combined with carboplatin in adult patients with advanced solid tumors who     progressed despite standard therapy or for whom no standard therapy exists or who might     benefit from treatment with carboplatin   "
196756|NCT00426595|"     Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most     children with cerebral palsy and mental retardation. Oral administration of enteric-coated     formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in     these patients who may be suffering from swallowing disorders. A suspension of omeprazole in     a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This     trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy     tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus     the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The     crossover study will consist of 2 consecutive treatment periods of 14 days.   "
196757|NCT00426608|"     A study to investigate the effects GSK561679 on part of the body's system that controls the     balance of many of the hormones (including cortisol).   "
196758|NCT00426621|"     This study will test the efficacy and safety of topical diclofenac sodium gel in the     treatment of knee osteoarthritis.   "
196759|NCT00426634|"     This study will examine whether exposure to the increased levels of mold and other allergens     in New Orleans post-Hurricane Katrina affect symptoms in children with asthma. It will also     determine if having an asthma counselor (AC) can reduce a child s asthma symptoms in this     setting. An AC helps the families in the study obtain appropriate health care, medicines and     social services for their asthmatic child and instructs them about avoiding allergens and     ridding allergens from the home.      Children between 4 and 12 years of age living in Orleans Parish or surrounding areas impacted     by flooding who have moderate to severe asthma may be eligible for this study.      Parents provide a family medical history and information about the child s asthma symptoms,     medications and medical history. The children undergo the following procedures:        -  Medical examination and blood tests        -  Spirometry (for children 6 and older) or peak flow (for children under 6) test: For          spirometry, the child wears a nose clip and breathes into a mouthpiece attached to a          machine that measures how fast air moves out of the child s lungs. For the peak flow          meter test, the child blows into a plastic tube after taking a deep breath.        -  Allergy skin testing: 24 common allergens are applied to the arm by little pricks or          scratches and the skin is observed for reactions to the allergens.      Study staff visit the participants homes three times during the 1-year study to test for     moisture, mold and other allergens. After the first visit, families are randomly assigned to     one of two groups. Group 1 participants attend two educational group sessions about asthma     and then three individual sessions. An AC visits the home one time during the study to     instruct the family on how to use supplies provided to reduce allergens in the home. Group 2     participants have an individual special teaching meeting with the AC at the end of the study.     After the meeting, the AC visits the home to instruct the family on use of the supplies.      Families are surveyed by phone every 3 months during the study to answer questions about the     child s asthma attacks, medicines used, doctor visits, school days, missed, or work days     missed to care for the child. At the end of the study, the child has a final medical     examination, blood test, and breathing test.   "
196760|NCT00426647|"     The primary objective of this equivalence study is to evaluate the efficacy of Norspan®     patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of     the hip, knee and/or lumbar spine.      The secondary objectives are to evaluate the safety and general satisfaction for the patients     in the two treatment groups.   "
196800|NCT00416871|"     RATIONALE: Biological therapies, such as interleukin-2 and interferon, may stimulate the     immune system in different ways and stop tumor cells from growing. It is not yet known     whether interleukin-2 given by infusion is more effective than interleukin-2 given by     injection when combined with interferon in treating metastatic kidney cancer.      PURPOSE: This randomized phase III trial is studying interleukin-2 given by infusion to see     how well it works compared to interleukin-2 given by injection when combined with interferon     in treating patients with metastatic kidney cancer.   "
196763|NCT00426686|"     Thrombotic thrombocytopenic purpura (TTP) is a thrombotic microangiopathy defined by the     spontaneous formation of platelet thrombi in the microvessels. These platelet microthrombi     are responsible for a mechanical hemolytic anemia, a thrombocytopenia and a multivisceral     ischemia. TTP is a rare but life-threatening disease in the absence of appropriate treatment     (PLASMATHERAPY). The onset of the disease usually occurs in adulthood (MOSCHCOVITZ syndrome)     and rarely in childhood (UPSHAW-SCHULMAN syndrome). TTP is either sporadic or recurrent with     multiple unpredictable relapses. TTP pathophysiology has remained obscure until a new     metalloprotease, ADAMTS13, has been demonstrated to be involved in about 90% of all cases.     Physiologically, ADAMTS13 function consists in limiting the size of von Willebrand factor     (VWF) multimers and consequently, their hemostatic capacity. A large majority of TTP is     associated with a severe deficiency of ADAMTS13. In most cases, ADAMTS13 severe deficiency is     acquired via auto-antibodies to ADAMTS13; more rarely, ADAMTS13 deficiency is hereditary via     ADAMTS13 gene mutations. ADAMTS13 auto-antibodies are either inhibitory of the catalytic     activity or non inhibitory. ADAMTS13 mutations are spread all over the gene.      TTP prognosis is quite heterogeneous. Indeed, in about one third of the patients, TTP is     refractory to PLASMATHERAPY and/or chronic relapsing. Until now, TTP prognosis factors are     not known. Their identification is however crucial both to adapt the curative treatment of an     acute episode (addition of first intention immunosuppressive agents to PLASMATHERAPY) and to     prevent relapses.      In this context, the aim of the current project is to identify some ADAMTS13 related     prognosis factors in TTP. A national prospective multicenter study including both adult and     pediatric patients with TTP related to a severe ADAMTS13 deficiency will be designed over a     three-year period. This study will involve our group as the French reference center for     ADAMTS13 and 10 clinical departments from various French hospitals. Patients will be tested     for ADAMTS13 activity and antigen, ADAMTS13 antibodies and ADAMTS13 gene sequencing. Our main     hypothesis is that the inactivation of the ADAMTS13 domains crucial for its catalytic     activity, either by inhibitory auto-antibodies (acquired TTP) or by genetic mutations     (hereditary TTP) is a major bad prognosis factor.   "
196764|NCT00426699|"     Enteroviruses can infect most human organ systems, especially the heart, nervous system and     pancreas. Whether Enteroviruses can also affect the kidneys is not known yet. Therefore we     will analyze urine of children with a suspected enteroviral infection for enteroviruses and     signs of kidney infection.   "
196765|NCT00426712|"     The purpose of this study is to find out if a new investigational hepatitis B virus vaccine,     HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney     function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease, and     are expected to eventually go on hemodialysis.   "
196766|NCT00426725|"     The suggested research is aimed to test the effectiveness of an external mechanical device to     be applied and used by the parturient herself in pain relieving during labour . The research     is to be performed in a controlled closely observed way, to ensure the safety of the involved     parturient and newborn.   "
196767|NCT00426751|"     Multinational, multicentre, randomised, prospective, open, parallel group study directly     comparing two glycoprotein-IIb/IIIa inhibitors, abciximab and eptifibatide, added early to     standard treatment before primary PCI of STEMI patients with respect to effect on     sum-ST-resolution after 60 minutes post-procedure and other measures of myocardial     reperfusion   "
196768|NCT00426764|"     The purpose of this study is to evaluate the activity of romidepsin in patients with     progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with     systemic therapy.   "
196769|NCT00416455|"     This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and     ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and     radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial     cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography     (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging     (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or     endometrial cancer.   "
196770|NCT00416468|"     This study will assess the bioavailability of aliskiren and valsartan as a single tablet     compared to the same doses of the two drugs given as two separate tablets in healthy     subjects.   "
196771|NCT00416481|"     RATIONALE: Questionnaires that measure the ability of older patients to think, learn,     remember, and make judgments and carry out daily activities may improve the ability to plan     treatment for patients with cancer.      PURPOSE: This clinical trial is studying ways to assess older patients with cancer.   "
196772|NCT00416494|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some find tumor cells and kill them or carry tumor-killing substances to     them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may     also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine     and oxaliplatin together with bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine     together with bevacizumab works in treating patients with metastatic or recurrent colorectal     cancer.   "
196773|NCT00416507|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, fluorouracil, and cisplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving more than one drug (combination chemotherapy) together with radiation therapy may kill     more tumor cells. It is not yet known which treatment regimen is more effective for     pancreatic cancer.      PURPOSE: This randomized phase III trial is studying gemcitabine, fluorouracil, cisplatin,     and radiation therapy to see how well they work compared to gemcitabine alone in treating     patients with nonmetastatic pancreatic cancer that cannot be removed by surgery.   "
196774|NCT00416520|"     This is a phase III multi-centre study in three periods: the first period is a phosphate     binder washout for 4 weeks, the second period is an open-label, randomised, parallel group,     flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with     placebo for 4 weeks.   "
196775|NCT00416533|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and prednisone, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel, doxorubicin, and     prednisone together works in treating patients with advanced prostate cancer that has not     responded to hormone therapy.   "
196776|NCT00416546|"     This is a study to assess the safety effects after multiple doses of AEB071 in healthy     volunteers and to compare the ethnicity, metabolic, and safety effects between Caucasian and     Japanese healthy subjects receiving single and multiple doses of AEB071.   "
196779|NCT00416585|"     serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with     isotretinoin for sever acne   "
196786|NCT00416676|"     RATIONALE: Drugs used in chemotherapy, such as vincristine, cyclophosphamide, cisplatin,     etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving combination chemotherapy before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed. Giving combination     chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after     surgery.      PURPOSE: This phase III trial is studying how well giving combination chemotherapy and     surgery with or without radiation therapy works in treating patients with stage 2 or stage 3     neuroblastoma.   "
196787|NCT00416689|"     RATIONALE: Understanding how nausea or vomiting caused by chemotherapy effects a patient's     treatment decisions may help doctors plan better cancer treatment and may help patients live     more comfortably.      PURPOSE: This clinical trial is studying nausea or vomiting in patients who are receiving     chemotherapy for breast cancer or lung cancer.   "
196788|NCT00416702|"     This study is designed to evaluate the safety and pharmacokinetic effects of indacaterol in     subjects with impaired liver function in comparison with healthy subjects   "
196789|NCT00416715|"     This phase II trial is studying vitamin D deficiency, muscle pain, joint pain, and joint     stiffness in postmenopausal women receiving letrozole for stage I-III breast cancer. Learning     about vitamin D deficiency and muscle pain, joint pain, and joint stiffness in patients     receiving letrozole for breast cancer may help doctors plan treatment and may help patients     live more comfortably   "
196790|NCT00416728|"     This study will assess the bioavailability of aliskiren and valsartan as a single tablet     compared to the same doses of the two drugs given as two separate tablets in healthy     subjects.   "
196791|NCT00416741|"     The objective of this protocol is to improve awareness, treatment, and control of metabolic     syndrome, within primary prevention of cardiovascular disease, by implementing guidelines,     after training of the participating physicians.   "
196792|NCT00416754|"     RATIONALE: Genetic counseling and using an interactive computer program may help women at     risk for breast cancer make medical decisions about treatment.      PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how     well it works when given together with or without a medical decision-making computer program     in women at risk for BRCA1 or BRCA2 mutations.   "
196793|NCT00416767|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well combination chemotherapy works as     first-line therapy in treating patients with locally advanced or metastatic neuroendocrine     tumors of the duodenum or pancreas that cannot be removed by surgery.   "
196794|NCT00416780|"     RATIONALE: Meeting together with other breast cancer patients to receive psychosocial support     and to learn to reduce stress may help patients cope with their diagnosis, have a better     quality of life, and live more comfortably.      PURPOSE: This randomized clinical trial is studying how well psychosocial support works in     treating women with recurrent breast cancer or stage I, stage II, or stage IV breast cancer.   "
196795|NCT00416793|"     This phase II trial is studying how well giving bortezomib together with carboplatin works in     treating patients with metastatic pancreatic cancer. Bortezomib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as carboplatin, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving bortezomib together with     carboplatin may kill more tumor cells.   "
196807|NCT00416962|"     This study is designed to assess the safety and pharmacokinetic effects of oseltamivir     administration alone or in combination with amantadine in healthy volunteers.   "
197306|NCT00423410|"     This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic effects of a     novel anti-cancer drug, EPC2407, administered to patients with advanced cancer which have not     responded to or have recurred following treatment with available therapies   "
196796|NCT00416819|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as rituximab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Giving rituximab together with combination chemotherapy     may kill more cancer cells.      PURPOSE: This clinical trial is studying the side effects and best ways to give combination     chemotherapy together with rituximab in treating patients with newly diagnosed primary CNS     lymphoma.   "
196797|NCT00416832|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill cancer cells. Giving combination chemotherapy together with     radiation therapy may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects and how well giving combination     chemotherapy together with radiation therapy works in treating young patients with Hodgkin's     lymphoma.   "
196798|NCT00416845|"     This study is designed to assess the effects of two doses of FTY720 on lung (pulmonary) and     cardiac (heart) functions in healthy volunteers.   "
196799|NCT00416858|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     radiation therapy together with combination chemotherapy before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed. Giving these     treatments after surgery may kill any tumor cells that remain.      PURPOSE: This randomized phase III trial is studying radiation therapy together with     combination chemotherapy to see how well they work with or without surgery in treating     patients with locally advanced esophageal cancer that can be removed by surgery.   "
196919|NCT00418418|"     This is a prospective double blind trial of intraoperative transmyocardial bone     marrow−derived mesenchymal cell transplantation vs placebo in patients with low left     ventricular ejection fraction scheduled to coronary bypass operation.   "
196801|NCT00416884|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation     (TBI) before a donor stem cell transplant helps stop the growth of cancer cells. It also     stops the patient's immune system from rejecting the donor's stem cells. The donated stem     cells may replace the patient's immune system and help destroy any remaining cancer cells     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte     infusion) that have been treated in the laboratory after the transplant may help increase     this effect. Sometimes the transplanted cells from a donor can also make an immune response     against the body's normal cells. Giving cyclosporine and alemtuzumab, and removing the T     lymphocyte cells(T cells) from the donor cells before transplant, may stop this from     happening.      PURPOSE: This clinical trial is studying how well giving fludarabine, alemtuzumab, and     total-body irradiation together with donor stem cell transplant and donor white blood cell     (WBC) infusion works in treating patients with chronic phase chronic myelogenous leukemia     (CML) that did not respond to previous imatinib mesylate.   "
196802|NCT00416897|"     RATIONALE: Dexamethasone is used to treat multiple myeloma. Drugs used in chemotherapy may     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Plasma exchange is a process in which certain cells are separated from the plasma     in the blood by a machine and then only the cells are returned to the patient. Dexamethasone     and plasma exchange may be an effective treatment for acute kidney failure caused by multiple     myeloma. It is not yet known whether giving dexamethasone and chemotherapy together with     plasma exchange is more effective than giving dexamethasone and chemotherapy alone in     treating patients with multiple myeloma and acute kidney failure.      PURPOSE: This randomized phase III trial is studying dexamethasone, chemotherapy, and plasma     exchange to see how well they work compared with dexamethasone and chemotherapy alone in     treating patients with newly diagnosed multiple myeloma and acute kidney failure.   "
196803|NCT00416910|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine, mitoxantrone, and     cyclophosphamide, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving more than one drug (combination     chemotherapy) may kill more cancer cells. Colony stimulating factors, such as G-CSF, may     increase the number of immune cells found in bone marrow or peripheral blood and may help the     immune system recover from the side effects of combination chemotherapy. It is not yet known     whether giving combination chemotherapy alone is more effective than combination chemotherapy     together with G-CSF in treating patients with chronic lymphocytic leukemia.      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy together     with G-CSF to see how well it works compared to giving combination chemotherapy alone in     treating patients with relapsed stage I, stage II, stage III, or stage IV chronic lymphocytic     leukemia.   "
196804|NCT00416923|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Giving rituximab intrathecally may     be an effective treatment for recurrent CNS lymphoma.      PURPOSE: This phase I trial is studying the side effects and best dose of intrathecal     rituximab in treating patients with recurrent CNS lymphoma.   "
196805|NCT00416936|"     The use of mobile phones in the operating room (OR) has become widespread, because of the     lack of reports on serious problems. Since mobile phones are used in close body contact and     since, as for most non-medical electronic equipment, there are no cleaning guidelines that     meet hospital standards, the hygiene risk involved in using mobile phones in the OR has not     yet been determined.   "
196806|NCT00416949|"     RATIONALE: Radioactive iodine kills thyroid cancer cells by giving off radiation.      PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I     131 works in treating patients with thyroid cancer.   "
196809|NCT00416988|"     RATIONALE: An educational program may be effective in increasing monthly skin     self-examinations to detect melanoma in healthy participants.      PURPOSE: This randomized clinical trial is studying how well an educational program works in     increasing monthly skin self-examinations to detect melanoma in healthy participants.   "
196810|NCT00417001|"     Colonoscopy for investigation of lower gastrointestinal complaints or for colon cancer     screening is one of the more frequent procedures performed by the Divisions of General     Surgery and Gastroenterology. Traditionally, this has been performed while under conscious     sedation (medication induced) which may improve patient acceptance and tolerance of the     procedure but adds to the operative risk of the procedure. The investigators propose a     randomized prospective blinded trial to assess the utility of adding pleasing olfactory     stimulation to the inhaled oxygen during the conscious sedation for colonoscopy in an effort     to reduce the total doses of sedatives required while maintaining a similar level of     sedation. This may decrease the overall period of recovery for the patient, increase the     number of procedures which may be accomplished, and decrease the potential complications     related to conscious sedation.   "
196811|NCT00417014|"     RATIONALE: Drugs used in chemotherapy, such as chlorambucil, vinblastine, procarbazine, and     prednisolone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to     kill cancer cells. Giving more than one drug (combination chemotherapy) together with     radiation therapy may kill more cancer cells.      PURPOSE: This clinical trial is studying how well giving combination chemotherapy and/or     radiation therapy works in treating young patients with Hodgkin's lymphoma.   "
196820|NCT00417131|"     Islets of Langerhans intended for clinical transplantation are labelled with a radioactive     tracer. The tracer is retained in viable cells of the transplant. At infusion     (transplantation) of the islets into the portal vein the tracer can be followed for two hours     with positron emission tomography (PET). Imaging and calculations can give estimates of the     proportion of surveying islets and the rate of early destruction. Also the distribution of     the islets into the liver can be viewed.   "
196821|NCT00417144|"     The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS     patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation     during an IVF cycle. Our hypothesis is that the GnRH antagonist protocol reduces the     occurrence and severity of OHSS compared to the GnRH agonist protocol.   "
196934|NCT00418613|"     A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic     Obstructive Pulmonary Disease (COPD).   "
196812|NCT00417027|"     Studies suggest that administration of maintenance epidural solutions as programmed or     automated intermittent boluses, rather than continuous infusions, result in lower bupivacaine     consumption, decreased need for manual boluses by the anesthesiologist, and greater patient     satisfaction. In this technique, the epidural maintenance dose is administered as a bolus by     the infusion pump at regular intervals instead of as a continuous infusion. However, the     optimal combination of bolus volume and dosing interval has not been determined. At one end     of the spectrum, a small volume and short bolus dose interval will likely behave like a     continuous infusion. At the other end of the spectrum, a large volume and long bolus dose     interval may lead to an increased incidence of breakthrough pain. The purpose of this     randomized, double-blind trial was to determine how manipulation of the programmed     intermittent time interval and volume influences total drug use, quality of analgesia, and     patient satisfaction during maintenance of labor analgesia. We hypothesized that manipulation     of the programmed intermittent bolus time interval and volume during the maintenance of     epidural labor analgesia influences total drug use, quality of analgesia and patient     satisfaction.   "
196813|NCT00417040|"     This pilot clinical trial studies how well using the internet to collect symptoms and the     ability to carry out daily activities works in patients with enrolled on Cancer and Leukemia     Group B (CALGB) studies. A study that evaluates a patient's ability to use a clinic waiting     room computer to report their symptoms and their ability to carry out daily activities may     help doctors understand a patient's use of a computer to report symptoms.   "
196814|NCT00417053|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs     to be removed. Sometimes, after surgery, the tumor may not need more treatment until it     progresses. In this case, observation may be sufficient. It is not yet known which     combination chemotherapy regimen given together with surgery, with or without autologous bone     marrow or peripheral stem cell transplant, is more effective in treating newly diagnosed     neuroblastoma.      PURPOSE: This phase III trial is studying combination chemotherapy to see which regimen given     together with surgery, with or without autologous bone marrow or peripheral stem cell     transplant, works in treating infants with newly diagnosed neuroblastoma.   "
196815|NCT00417066|"     The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist     protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian     stimulation. Our hypothesis is that the antagonist protocol provides better IVF outcomes     compared to the flare up protocol in this group of patients.   "
196816|NCT00417079|"     This is a randomized, open-label, multi-center study comparing the safety and efficacy of     XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone     refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen.     The primary objective is overall survival. Secondary objectives include progression free     survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain     response/progression, overall safety, and pharmacokinetics. Patients will be treated until     disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients     will have long-term follow-up for a maximum of up to 2 years.   "
196817|NCT00417092|"     The purpose of this study is to determine which pacing mode after coronary artery bypass     grafting in patients with reduced left ventricular function is hemodynamically favorable.   "
196837|NCT00417352|"     Current improvements of the design of the upper limb prosthesis include advanced technology     in control systems and electronic circuitry that mimic human motion and improve function of     the prosthesis. Often times these improvements require large amounts of power, circuitry and     excess mass distally along the prosthesis that may require greater effort from the user. Poor     function of an upper limb prosthesis may cause awkward compensatory motion. Aberrant     movements, such as these compensatory movements are known to cause greater stress to     remaining joints. Amputees are forced to decide if the extra function provided by the     advanced electronics is worth carrying the extra mass which may cause fatigue, socket issues     and greater stress on the remaining joints. An example is the wrist rotator component of an     upper limb prosthesis which may allow greater function and reduce compensatory motion, but     adds mass distally, potentially causing greater torques on remaining joints.      GOALS OF THE STUDY:      There are two main goals of this study:        1. to determine the impact of an upper limb prosthesis without a wrist rotator on the          compensatory motion and torques in the remaining joints during common tasks        2. to determine the impact of the location (distally or proximally) of a wrist rotator on a          upper limb prosthesis on the compensatory motion during common tasks      HYPOTHESES:        1. There will be a statistically significant difference in range of motion of the upper          limb joints between healthy subjects, braced subjects and upper limb amputees during          four common tasks.        2. There will be a statistically significant difference in joint upper limb joint torques          between healthy subjects, braced subjects and upper limb amputees during three common          tasks.        3. There will be a statistically significant difference in upper limb angles and joint          torques between mass added distally and mass added proximally during common tasks.   "
196838|NCT00417365|"     Comparing the new Stainless Steel WaterWorks® douching device to a commercially available     douching device using just water for safety and efficacy of odor abatement.   "
196818|NCT00417105|"     Although remarkable progress has been made, chronic kidney disease still poses a major burden     on both individual patients, as well as on society as a whole. There is a strong inverse     relationship between decreasing renal function, as estimated by glomerular filtration rate,     and mortality rate, especially death due to cardiovascular disease. The exact cause(s) remain     to be elucidated. Uremic toxins might play an important role.      In the course of decreasing renal function the concentration of numerous intracellular and     extracellular compounds vary from the non-uremic state. But still increasing number of uremic     retention solutes are being identified. Renal replacement strategies aim to remove     potentially harmful substances from the body. Traditionally much attention has been paid to     small water-soluble molecules such as urea nitrogen and creatinine. Based on the results of     the recent HEMO and ADEMEX studies, increases of small water-soluble solute removal above the     level reached with modern dialysis techniques - hemodialysis, peritoneal dialysis (HD, PD) -     seem not to be advantageous with regard to patient outcome. These findings may point to the     importance of other distinct groups of uremic retention solutes. In view of the data     described above, protein-bound solutes might be good candidates.      Several advantages of long duration hemodialysis have been observed, including a better     control of blood pressure by decreasing extracellular fluid volume, lowering peripheral     vascular resistance and improving endothelium-dependent and -independent vasodilation. A     normalization of heart rate variability and improvement of left-ventricular function was     noted as well. Furthermore, anemia control has been shown to be easier and several     nutritional parameters improved in patients treated with long duration HD. The therapy     results in higher small water-soluble solute removal, phosphate removal and greater     elimination of larger molecules (e.g. β2-microglobulin).      It seems an appealing question whether a better control of the serum levels of protein-bound     solutes can be achieved by long duration (nocturnal) hemodialysis. This might be another     advantage of this therapeutic modality, or may even in part explain the better outcome of     patients treated this way.      The study compares intermittent hemodialysis with long nocturnal hemodialysis with respect to     serum concentrations of several protein bound uremic toxins, as well as solute removal.   "
196819|NCT00417118|"     The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to     placebo in patients with generalized anxiety disorder. The secondary objectives are to     evaluate the efficacy of saredutant on disability and quality of life in patients with     generalized anxiety disorder, and to evaluate blood levels of saredutant.   "
196824|NCT00417183|"     The purpose of this study is to compare the efficacy of two controlled ovarian stimulation     protocols, the GnRH agonist protocol, widely known as the long protocol, and the flexible     GnRH antagonist protocol, in terms of pregnancy rates and embryological data, in infertile     patients receiving IVF treatment.   "
196825|NCT00417196|"     This study is designed to evaluate the safety, pharmacodynamic and pharmacokinetic effects of     individual escalating intravenous doses of QAX576 in healthy volunteers.   "
196826|NCT00417209|"     The purpose of this study is to compare the efficacy and the safety Larotaxel administered as     single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients     with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or     metastatic) previously treated with gemcitabine based therapy.   "
196827|NCT00417222|"     The purpose of this study is to investigate whether an angiotensin II receptor blocker     (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity     in hypertensive patients with stable chronic heart failure.   "
196828|NCT00417235|"     The purpose of this study is to determine whether a catheter dressing every 7th day is not     inferior to a catheter dressing every 3 days and if Chlorhexidine impregnated sponges are     effective in preventing catheter-related infections in ICUs.   "
196829|NCT00417248|"     Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety     and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.   "
196830|NCT00417261|"     This is a first-in-human study and is designed to evaluate the safety, tolerability,     pharmacodynamic and pharmacokinetic effects of a single and multiple-doses of ATF936 and     AXT914 administered orally in healthy subjects.   "
196831|NCT00417274|"     The purpose of this study is to determine whether quinacrine is effective in the treatment of     Androgen-Independent Prostate Cancer.   "
196832|NCT00417287|"     This study is being conducted to evaluate the clinical efficacy, biologic activity     (inhibition of PX-12 target thioredoxin-1) and effects of an expired metabolite of PX-12 in     patients with advanced pancreatic cancer.   "
196833|NCT00417300|"     This study will evaluate the comparative effectiveness of prolonged exposure therapy and     client centered therapy in treating adolescents with post-traumatic stress disorder related     to childhood sexual abuse or assault.   "
196834|NCT00417313|"     The purpose of this study is to investigate the feasibility, effectiveness, and duration of     treatment response of periosteal electro-acupuncture (osteopuncture) for osteoarthritis     (OA)-associated chronic knee pain.   "
196835|NCT00417326|"     The purpose of this study is to determine the safety and efficacy of ONO-5046Na in patients     with acute respiratory failure associated with community-acquired pneumonia   "
196836|NCT00417339|"     Study on intradialytic kinetics of protein-bound uremic retention solutes during long     nocturnal hemodialysis   "
196839|NCT00417378|"     The purpose of this study is to evaluate the efficacy and safety of a left ventricular assist     device in comparison to a standard treatment with an intraaortic balloon pump (IABP) in     patients with cardiogenic shock due to left ventricular failure following an acute coronary     syndrome (myocardial infarction).   "
196841|NCT00417404|"     Vitamin A is important for the development of healthy eyes and lungs. Very low birth weight     premature babies have low body stores of vitamin A and are prone to diseases of the eye and     lungs. Previous work has shown that intramuscular (IM) vitamin A reduces the number of babies     who require prolonged oxygen therapy, and may also reduce the number of babies affected by     retinopathy of prematurity (ROP)). There is also some evidence that the conjunctiva shows     signs of deficiency of vitamin A in premature infants, particularly those who develop ROP.     Our own work here in Glasgow suggests that, compared to babies born at full term, premature     babies' eyes are less sensitive to light and we believe that this may reflect shortage of     vitamin A in the eye. This study will examine the effects upon the eye of giving extra     intramuscular vitamin A to very low birth weight, premature infants. We will also measure     blood levels of vitamin A and calculate liver stores of this nutrient.   "
196842|NCT00417417|"     This study will determine whether an experimental drug called Rilonacept can improve artery     function in patients with atherosclerosis, a disease in which fatty deposits in arteries     cause the vessels to stiffen, impeding blood flow. Atherosclerosis is believed to be caused     in part by inflammation. Rilonacept blocks production of a protein called CRP, which, in high     levels in the blood is associated with increased inflammation. Patients with coronary artery     disease who have elevated blood levels of CRP are at increased risk of heart attack, heart     failure and sudden death compared with people who have lower levels of the protein.      Patients 18 years of age and older with atherosclerotic coronary artery disease with a CRP     level between 2 and 10 mg/L may be eligible for this study.      Patients are randomly assigned to receive four doses of either Rilonacept or placebo, given     at 2-week intervals as injections under the skin. In addition to treatment, patients undergo     the following procedures during eight visits to the NIH Clinical Center:        -  Visit 1 (screening visit): Medical history, measurement of vital signs (temperature,          blood pressure, heart rate and breathing rate), electrocardiogram (EKG) and blood tests.        -  Visit 2: Blood tests, chest X-ray, treadmill exercise testing, tuberculin skin test,          brachial artery flow-mediated dilation. Brachial artery flow-mediated dilation is used          to measure how well the brachial artery (artery inside the elbow) dilates. An ultrasound          device placed just above the elbow measures the size of the brachial artery and the flow          of blood through it before and after a pressure cuff is inflated around the forearm.        -  Visit 3: Injection of study drug.        -  Visits 4, 5, and 6: Review of any changes in health or medical treatment, measurement of          vital signs, blood tests, EKG, injection of study drug.        -  Visit 7: Review of any changes in health or medical treatment, measurement of vital          signs, blood tests, EKG, treadmill exercise testing, brachial artery flow-mediated          dilation.        -  Visit 8: Review of any changes in health or medical treatment, measurement of vital          signs, blood tests, EKG, treadmill exercise testing, brachial artery flow-mediated          dilation.   "
196843|NCT00417430|"     SLE(Systemic Lupus Erythematosus) is an autoimmune disese that primarily occurs in women(9:1     compared to men). The disease is activated by genetic and environmental factors, yet the     female gender is the strongest risk factor. The sex hormone estrogen has been proven in the     past to be an enhancer of the immune response. Estrogen serves as a ligand for two specific     receptor proteins. Lab studies that we have already done have shown estrogen significantly     increases these two ligands in the T cells from SLE females, but not in T cells from normal     women. These estrogen-dependent increases are blocked by the estrogen receptor antagonist ICI     182,780. The objective of this research is to investigate if ICI 182,780 alters disease     progression and/or activity in females with SLE and may provide a new treatment for women     with SLE. This is based on previous work we have done.   "
196881|NCT00417924|"     Vision loss from diabetes is often preventable with timely detection and treatment. Patients     with diabetes may not understand the importance of annual dilated eye examinations or     recognize the benefits of early detection of diabetic eye disease. The proposed research     project compares usual eye care to eye care emphasizing patient education for adult patients     with diabetes.   "
196844|NCT00417443|"     We propose performing a study in which we compare the effects of bupivacaine and fentanyl     with a different drug combination − bupivacaine and clonidine. The principal research     questions of the study are:        1. To compare the effect of clonidine (with bupivacaine), injected into the epidural space          on the extent of hyperalgesia (abnormal pain/sensitivity in the uninjured skin          surrounding the operation site) in patients undergoing operations for bowel disease,          with that of fentanyl (with bupivacaine).        2. To compare the effect of clonidine (with bupivacaine), injected into the epidural space          on the incidence of chronic pain 6 months after surgery for bowel disease, with that of          fentanyl (with bupivacaine).   "
196845|NCT00417456|"     The purpose of this study is to test the efficacy, timeliness, and user satisfaction of an     online E-Visit application that uses store-and-forward technology for acne patients     requiring dermatologic care for their condition. Hypotheses:        1. That an E-Visit is an effective alternative to in-person clinic care for patients with          mild to severe facial acne.        2. That providers and patients will be satisfied with this model.        3. That mean wait times for new and return visits will be reduced through the E-Visit          model.        4. That this prototype for care will improve clinic workflow, offer additional patient          access, and allow urgent cases to be seen earlier.   "
196846|NCT00417469|"     The purpose of this research study is to compare subject comfort during and after injection     with NADGL and Captique® Injectable Gel, in the nasolabial folds. Captique® is an     FDA-approved product without lidocaine and is manufactured by Genzyme Biosurgery (Ridgefield,     NJ). NADGL is a new product (not FDA approved) with lidocaine and is also manufactured by     Genzyme Biosurgery. We do not know which of these treatments results in less pain during and     after injection. The safety of NADGL is also being studied.   "
196847|NCT00417482|"     In patients with Alzheimer's disease (AD) who respond to antipsychotic treatment of psychosis     and/or agitation/aggression, the relapse risk after discontinuation is not established. AD     patients with psychosis and/or agitation/aggression receive 16 weeks of open risperidone     treatment (Phase A). Responders are then randomized, double-blind, to one of three arms in     Phase B: (1) continuation risperidone for 32 weeks, (2) risperidone for 16 weeks followed by     placebo for 16 weeks, (3) placebo for 32 weeks. The primary outcome is time to relapse of     psychosis/agitation.   "
196848|NCT00417495|"     The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast     Cancer   "
196849|NCT00417508|"     The purpose of this study is to investigate whether nutritional supplementation will improve     functional outcome parameters and nutritional status in elderly patients.   "
196850|NCT00417521|"     This trial seeks to investigate the feasibility and effectiveness of delivering a newly     manualized family-based treatment for adolescents with anorexia nervosa   "
196851|NCT00417534|"     The aim of this study is to identify genetic loci,or gene variations contributing to     inflammation and to the development of CHD. We will compare coronary angiogram results to     genetic findings within coronary artery disease patients and in patients with normal     coronaries.   "
196852|NCT00417547|"     The aim of this research is to examine the social, psychological and Islamic veil practicing     (IVP), non-complete IVP and Inconsiderate to IVP correlates of body mass index (BMI) status     in a women population. It is hypothesized that women who are IVP would differ on depression,     and social variables compared with their non-practicing peers.   "
197915|NCT00430781|"     This study is being conducted to compare the efficacy and safety of pazopanib in combination     with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic     cervical cancer   "
196853|NCT00417560|"     This is a single center, open-label, Phase I/II study in up to 100 adult subjects, aged 18     years and older who are at occupational risk of exposure to live H5N1 viruses. This study is     designed to investigate the safety, reactogenicity, and immunogenicity of two 90 µg doses of     an investigational inactivated influenza A/H5N1 virus vaccine given approximately 28 days     apart. A blood sample will be collected for immunogenicity evaluation prior to each     vaccination. Subjects will maintain a memory aid (appendix C4 and C13) to record oral     temperature and systemic and local AEs for 7 days after immunization. Subjects will be     encouraged to take their temperature around the same time each day. All subjects will receive     a safety follow-up telephone call at 1 to 3 days after each vaccination (approximately Day 2)     to elicit any AE and concomitant medication information. Subjects will return to the clinic 7     days after each vaccination for assessment of AEs and concomitant medications, a targeted     physical examination (if indicated), and review of the memory aid. At approximately Day 28     after the first vaccination, subjects will return to the clinic for evaluation of vital     signs, blood sample collection and safety follow-up, confirmation of eligibility criteria and     a second vaccination. Safety follow-up will be identical to that performed after the first     vaccination. At approximately Day 56 (or about 28 days after the second vaccination),     subjects will return to the clinic for immunogenicity blood sample collection, AE and     concomitant medication assessment, and targeted physical examination and vital sign     assessment (if indicated). At approximately Day 180 (6 months after the first vaccination),     subjects will return to the clinic for a final immunogenicity blood sample collection and     safety assessment.      Blood samples collected prior to each vaccination (Days 0 and 28) and on Days 56 and 180     after the first vaccination will be tested at the CDC Influenza Division Laboratory for the     levels of neutralizing and HAI antibodies and CMI responses.      The primary outcome measures will be the frequencies and severities of AEs and the GMTS and     proportions of subjects who achieve 4-fold rises in serum neutralizing and HAI titers against     the influenza A/H5N1 virus on Day 56. Serum HAI and neutralizing antibody responses     (including frequencies of 4 fold or greater rise in titer; GMTs; and proportions of subjects     achieving protective titers of neutralizing antibody 1 month and 6 months after first dose)     will also be assessed. A secondary outcome measure will be CMI responses evaluated 1 month     after the receipt of each dose of vaccine and 6 months after the receipt of the first dose of     vaccine.   "
196854|NCT00417573|"     -  This is the first study, that we are aware of, that will evaluate the efficacy of IgIV          in patients with IgG subclass deficiency.        -  Will provide data for further collaboration in extending study to involve other          immunological centers in the United States to study patients with similar disease.   "
196855|NCT00417586|"     Carotid stenosis, a condition in which plaque builds up inside the arteries of the neck and     blocks blood flow to the brain, is one common cause of stroke. This study will evaluate the     cost-effectiveness of using a new, specialized ultrasound device to screen individuals who     are at risk for carotid stenosis.   "
196856|NCT00417599|"     The prevalence of overweight in the United States Air Force (USAF) is about 22%. The     objective of this study is to compare the effectiveness of a minimal contact behavioral     therapy plus usual care group(MCBT+UC) using a controlled experimental comparison of usual     care(UC). Subjects are USAF personnel who are 5lbs below their Maximum Allowable Weight (MAW)     and heavier. The primary hypothesis is that: MCBT+UC will have significant weight loss as     compared to UC.   "
196857|NCT00417612|"     The purpose of this study is to determine the effectiveness of paricalcitol, a form of     synthetic vitamin D, in lowering parathyroid hormone (PTH) levels and reducing disease     symptoms in children and adults with X-linked hypophosphatemic (XLH) rickets.   "
196882|NCT00417937|"     To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus     twice daily in the treatment of patients with papulopustular rosacea.   "
196858|NCT00417625|"     This study will test the accuracy of magnetic resonance imaging (MRI) in measuring cardiac     perfusion (blood flow). MRI of the heart can measure blood flow to heart muscle, but     collateral coronary arteries (vessels that supply blood to the heart muscle) may reduce the     accuracy of the measurements. This study will perform special measurements of coronary artery     flow and pressure in patients undergoing heart catheterization and catheter-based treatment     (angioplasty and stenting) in order to compare for accuracy with cardiac MRI.      Patients 21 years of age and older with coronary artery blockage may be eligible for this     study. All participants undergo cardiac MRI, to produce images of the heart, as well as     special invasive blood flow testing during heart catheterization, angioplasty, and stenting.      During MRI, the subject lies on a table that can slide in and out of the scanner (a narrow     cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the     scanning process. The procedure lasts about 45 to 90 minutes. Since the heart moves during     breathing, subjects are asked to hold their breath intermittently for about 5-20 seconds. A     medicine called dipyridamole is injected through a vein in the subject's arm to increase     blood flow to the coronary arteries and help detect blockages. Pictures are taken of the     heart before, during, and after the dipyridamole injection. Another medicine called     gadolinium is also given through a vein. This medicine brightens the images to measure blood     flow.      During a separate catheterization, angioplasty, and stenting procedure, subjects undergo     additional invasive tests. The additional tests use a special guidewire to measure coronary     artery pressure and blood flow, as well as a special ultrasound to look inside the artery.      Patients have a repeat MRI about 2 months after the catheterization.   "
196859|NCT00417638|"     Rapid MI-ICE-Pilot is designed to demonstrate the safety and efficacy of the Celsius Control™     System (CCS) endovascular catheter to reduce the infarct size resulting from acute anterior     myocardial infarction when used in combination with cold saline as an adjunct to immediate     percutaneous coronary intervention (PCI) in patients with an occluded infarct-related artery.   "
196860|NCT00417651|"     The purpose of this study is to evaluate whether creating a gastrotomy (hole in the stomach)     during gastric surgery increases a patient's risk of intra-abdominal infection.      We hypothesize that a gastrotomy does not contaminate the abdomen with clinically significant     bacterial pathogens.   "
196861|NCT00417664|"     The purpose of this study is to determine whether the use of dexmedetomidine, a selective     α2-adrenergic receptor agonist with sedative, analgesic, and antinociceptive properties,     would be associated with a lower incidence of delirium when compared to propofol and     midazolam. We hypothesize that sedation with dexmedetomidine following cardiac surgery with     CPB will be associated with a lower incidence of postoperative delirium.   "
196862|NCT00417677|"     This study is being conducted to determine the Maximum Tolerated Dose (MTD) and efficacy of     the combined treatment of Temsirolimus and Sunitinib for the treatment of Advanced Kidney     Cancer   "
196863|NCT00417690|"     The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release     oral formulation of 4-aminosalicylic acid, in doses of 4 grams three times daily for 2 weeks     followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's     disease.   "
196864|NCT00417703|"     This study will quantify the intraocular pressure elevation in the immediate time period     following intravitreous injection. With more widespread use of intravitreous injections in     patients that may require several injections per year, it is important to document the sudden     increase in intraocular pressure, including the maximum intraocular pressure and the time     required for the intraocular pressure to return to baseline. This data may be useful in     stimulating additional studies to evaluate the long term ocular effects of repeated     intravitreous injections.      We hypothesize that the intraocular pressure increases significantly following intravitreous     injection and then returns to baseline during the initial thirty minutes following     ranibizumab injection.   "
196865|NCT00417716|"     Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema   "
196866|NCT00417729|"     To compare effect of acarbose versus glibenclamide treatment on mean amplitude of glyclemic     excursion and oxidative stress in diabetes individuals who failed to control their glucose by     metformin therapy alone   "
196959|NCT00426777|"     Prostate cancer patients treated with LHRH agonists (e.g., leuprolide) lose bone mineral     density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent     osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer     patients treated with LHRH agonists.   "
196867|NCT00417742|"     PROJECT CHEER is a randomized controlled trial designed to test the effectiveness of a     comprehensive focused approach to headache care. Three institutions are collaborating in this     trial by establishing special Headache Programs that can provide individualized treatment and     follow-up: Duke University Medical Center in Durham, NC; Thomas Jefferson University in     Philadelphia, PA; and Kaiser Permanente in San Diego, CA. Support and oversight are provided     by the U.S. Agency for Healthcare Research and Quality.      HEADACHE sufferers age 18 and over whose headaches interfere with their ability to work,     study or enjoy life are eligible for this trial. Half of the enrolled individuals will be     selected at random to receive care in the Headache Program and half will continue to receive     care as usual from their primary care providers.      EVALUATION is an important part of this project. Every participant completes a screening     interview and survey at the time of enrollment. The initial evaluation will provide an     accurate diagnosis of headache type(s). The results of this evaluation will be reported to     the primary care provider and may help to provide usual care. Subjects assigned to the     Headache Program are further evaluated by the program manager in consultation with a headache     specialist.      EDUCATION in headache care is provided to participants assigned to the Headache Program.      The classes include suggestions on diet and lifestyle as well as a review of medication use.      Note: The above is excerpted from the flyer we distributed to recruit patients to the trial.   "
196868|NCT00417755|"     COPD patients requiring ventilation may benefit from invasive or non invasive ventilation.     Non invasive ventilation is often incompatible with oral or enteral feding, due to gastric     dilatation and full mask therapy. At the other hand, invasive ventilation is associated with     incomplete enteral feeding and nutrition requirements are not reached. The aim of the study     was to compare the feeding delivery of COPD patients receiving invasive or non invasive     mechanical ventilation.   "
196869|NCT00417768|"     To determine if instillation of tissue plasminogen activator into a percutaneously drained     intra-abdominal abscess cavity results in faster resolution of the abscess compared to normal     standard of care.   "
196883|NCT00417950|"     To understand if acarbose, an alpha-glucosidase inhibitor usually for treating diabetes, will     further lower post meal glucose and inflammatory state when taking together with moderate     amount of alcohol during meal tolerance test in subjects with impaired glucose tolerance or     mild diabetes.   "
196935|NCT00418626|"     This study will be a formal assessment of the impact of hepatic function impairment on the     pharmacokinetics of nilotinib   "
196870|NCT00417781|"     Background: Attention deficit hyperactivity disorder (ADHD), characterized by inattention,     hyperactivity and impulsivity, is an early onset, common (5-10% worldwide; 7.5% in Taiwan),     clinically heterogeneous, impairing disorder. Despite the abundance of research on ADHD, the     vast majority of samples have been limited to Caucasians; there is limited information about     the expressions, patterns, correlates, and outcomes for ADHD in the Taiwanese population.      Specific Aims:        1. to investigate the neuropsychological functioning, and psychiatric, academic, and social          outcomes of ADHD at adolescence;        2. to examine the psychopathology and neuropsychological functioning among parents and          siblings of ADHD probands;        3. to determine the components of ADHD and neuropsychological functioning with the greatest          familial recurrence risks; and        4. to validate the classification of ADHD and comorbid subtypes of ADHD using psychosocial,          familial, neuropsychological and longitudinal data.      Subjects and Methods: This 5-year proposal consists of two parts: (1) a 3 year-retrospective     cohort study and family study design; and (2) a 2 year-prospective cohort study design.     Several Chinese version of rating scales will be prepared in the first 6 months. The sample     will consist of probands with (n=180) and without (n=90) ADHD, ages 11-16, recruited from the     Children's Mental Health Center, NTUH and an epidemiological study. The ADHD diagnosis has     been made 3-6 years ago prior to recruitment. Probands and their parents will be assessed     using the following measures (n=810) in the first 3 years. Only probands will be reassessed     in the last 2 years. The measures will include a psychiatric interview using K-SADS-E and     self-reports covering the individual and familial/environmental domains; and     neuropsychological tests (WISC-III, CPT, WCST, CANTAB). The informants include probands and     their parents and teachers.      Long-term Objectives: The long-term objectives are to identify the endophenotypes that are     close to the biological expression of genes underlying ADHD, to determine the familial     aggregation and its specificity regarding the components of ADHD, and neuropsychological     deficit, and to identify the impact of ADHD on academic, psychiatric, family, and social     outcomes; and to identify a cohort of families with ADHD for future neuroimaging,     neurophysiological, and molecular genetic studies.   "
196871|NCT00417794|"     The purpose of this study is to determine if atomoxetine hydrochloride improves inattention,     hyperactivity, and impulsivity problems in children exposed to alcohol during birth.   "
196872|NCT00417807|"     An open-label, non-comparative study conducted to investigate the activity and safety of     imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R.     Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated     according to Recist criteria   "
196873|NCT00417820|"     The purpose of this study is to assess the local tolerability of a single topical     administration of BCT194 in healthy volunteers and, potentially, to evaluate the safety,     tolerability, and efficacy of a multiple topical administrations in patients with psoriasis.   "
196874|NCT00417833|"     Purpose: Determine the short-term safety of intravitreal bevacizumab by multifocal     electroretinography (mf-ERG).      Methods: 120 eyes with choroidal neovascularization, proliferative diabetic retinopathy and     retinal vein occlusion received intravitreal bevacizumab (2.5mg/0.1cc). All patients     underwent best corrected visual acuity, fluorescein angiography, optical coherent tomography     and mf-ERG before and 1 month after treatment.   "
196875|NCT00417846|"     The purpose of this study is to determine the sensitivity of the optical coherence tomography     (OCT) test in detecting neovascular AMD in eyes at high risk for CNV development. In order to     test this hypothesis, we are conducting a multi-center clinical study at four participating     clinical centers. A total of 227 participants will be enrolled. Participants will be     followed-up for a period of two years, or until CNV develops in the study eye for which     treatment is recommended, to determine the occurrence of CNV. The fundamental design     principles of the study are simplicity and parsimony.   "
196876|NCT00417859|"     The goal of this study is to provide gait parameters as a new objective method to assess     total knee arthroplasty outcome between patients with fixed- and mobile-bearing, using an     ambulatory device with minimal sensor configuration.   "
196877|NCT00417872|"     The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg     b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of     Clotridium difficile colitis after seven days of treatment. Secondary objectives are to     provide information on the times from first dose to last unformed stool and resolution of     symptoms of colitis, the sustained response rates for the different tratment groups and the     effect of treatment on Clostridium difficile toxin enzyme immunoassay/culture results during     hospitalization.   "
196878|NCT00417885|"     To assess progression-free survival at the combination dose determined in the Phase 1 portion     of the study, and safety of sunitinib combined with exemestane in patients with metastatic or     locally-recurrent, unresectable breast cancer.   "
197037|NCT00427999|"     The purpose of this study is to evaluate the efficacy, tolerability and safety of a     multi-targeted therapy in patients with hormone-refractory prostate cancer.   "
196879|NCT00417898|"     This study will determine the safety of 500mg of aspirin added to IV TPA at standard doses to     prevent re-occlusion of cerebral vessels after successful reperfusion. In ischemic stroke     brain arteries are occluded either by an embolus originating in the heart or large vessels     leading to the brain or by a process of acute thrombosis of the cerebral arteries over a     ruptured atherosclerotic plaque. Rupture of the plaque exposes thrombogenic elements within     the plaque and leads to accumulation and activation of platelets and induction of the     clotting cascade eventually leading to acute thrombosis and occlusion of the artery. TPA is     currently approved by the Food and Drug Administration to treat heart and brain problems     caused by blockage of arteries. It activates plasminogen and leads to disintegration of the     thrombus/embolus. It is effective only if begun within 3 to 4.5 hours of onset of the stroke     because of potential deleterious side effects including life threatening symptomatic     intracranial hemorrhage (sICH) when the drug is administered outside of this time window.      Reperfusion of the ischemic brain (i.e. timely opening of the occluded artery) with TPA is     associated with improved outcome. However, in about 33% of patients that have successfully     reperfused after TPA the artery re-occludes within the first few hours resulting in worsening     neurological symptoms and worse functional outcome. This re-occlusion is speculated to result     from re-thrombosis over an existing ruptured atherosclerotic plaque. This is explained by the     relatively short half life of TPA leaving the exposed ruptured plaque intact which leads to     re-activation of platelets and clotting factors and re-thrombosis. Thus, we hypothesize that     the addition of an antiplatelet agent to TPA would result in lower rates of re-occlusion     after AIS. The FDA approved TPA for patients with AIS but discouraged the concomitant use of     anti-platelet or anti-thrombotic drugs for the first 24hours after administration of TPA     because of concerns that such therapy may result in increased rates of intracerebral     hemorrhage. Aspirin is a well known platelet anti-aggregant that works by inhibition of     cycloxygenase 1 and reduction in thromboxane A levels. It has a rapid onset of action and     additional potential beneficial anti-inflammatory effects in patients with AIS. The     international stroke study showed that acute treatment of stroke patients with 500mg of     aspirin is safe and feasible and results in better outcome. Furthermore, the drug was safe in     these circumstances with an ICH rate of only .      Therefore, the purpose of this clinical trial is to examine the safety and efficacy of the     combination of aspirin with rt-TPA in patients with AIS.   "
196880|NCT00417911|"     Multiple myeloma is a malignant incurable hematological disease where survival has been     significantly improved by high-dose melphalan with autologous stem cell support (ASCT) in     younger patients. However, the disease will eventually relapse and new treatment is demanded.     Bortezomib is a newly approved drug for treating relapsing multiple myeloma. It has a     different biological effect and response even in patients refractory to conventional     chemotherapy. The purpose of the study is in a randomized design to investigate if addition     of bortezomib by 20 injections during a 4 months period starting 3 month after ASCT can     prolong the time to progression compared to patients receiving no consolidation or     maintenance therapy.   "
196885|NCT00417976|"     This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine     then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients'     response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response     Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor     marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure     response.   "
196886|NCT00417989|"     Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for     subjects in the 722 Group is greater than that for subjects in the Control (MDI) Group.      Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic     variability, Area Under the Curve (AUC); Quality of Life; and Health Economic Outcomes (MRU)   "
196887|NCT00418002|"     The purpose of this study is to assess safety and tolerability of AQW051 administered in     single and multiple doses to elderly healthy volunteers. In addition, pharmacokinetic effects     will be assessed and the possible effects on cognition.   "
196888|NCT00418015|"     Pharmacogenetics has allowed clinicians to identify associations between an individual's     genetic profile and his/her response to drugs. The A118G (c.188A>G)is a single nucleotide     polymorphism (SNP) of the mu-opioid receptor (OPRM1). The mutated protein, N40D, appears to     increase the binding affinity and potency of beta-endorphin approximately 3-fold. Individuals     carrying the variant receptor gene (A118G) may show differences in some of the functions     mediated by beta-endorphin action at the altered OPRM1. Combined spinal-epidural (CSE)     analgesia is a commonly utilized technique for labor analgesia. Analgesia is initiated with     the intrathecal administration of a lipid-soluble opioid (e.g. fentanyl), sometimes combined     with a local anesthetic. The mean (± SD) duration of analgesia after intrathecal fentanyl 25     microgram was 89 ± 43 min. The ED50 of intrathecal fentanyl for labor analgesia varies     between 14 microgram to 18.2 microgram. The wide variability in the duration of analgesia, as     was well the differences in ED50 may result from differences known to affect labor pain     (e.g., ethnicity, parity, stage of labor). Another possible explanation for the differences     in opioid requirements and duration, as well as incidence of side effects such as itching and     nausea/vomiting, is that opioid responsiveness is determined by genetic variability of the     µ-opioid receptor. The ED50 for intrathecal fentanyl labor analgesia was significantly lower     for parturients carrying the A118G variant of the mu-opioid receptor, compared to parturients     with the A118 wild type receptor. The purpose of this study is to determine whether     polymorphism at nucleotide 118 of OPRM1 influences the duration of intrathecal opioid     (fentanyl) labor analgesia, and intrathecal opioid (morphine) postoperative analgesia.   "
196901|NCT00418184|"     The primary objective of this trial is to determine whether an oral administration of     Phosphatidylserine-Omega3 would significantly improve the clinical symptoms of children     suffering from ADHD. Both the behavior and the academic achievements aspects will be     evaluated. In addition, we intend to measure side-effects and adverse events and to examine     the possible correlation between biochemical and behavioral alterations.   "
197038|NCT00428012|"     The purpose of this study is to determine whether psychological intervention is effective in     improving quality of life, mood, and relationships among adults with end-stage renal disease     who are awaiting kidney transplantation.   "
196889|NCT00418028|"     Capecitabine is active in metastatic breast cancer but the conventional schedule (1250     mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in     up to 50% of patients leading to those reductions. There are theoretical reasons to     administer S-phase specific agents in continuous, protracted rather than intermittent     schedules. The investigators study compares the standard schedule (1250 mg/m2/12 hr 2 weeks     on, one week off) with a continuous administration schedule (800 mg/m2/12hr). The latter     administer approximately the same cumulative dose of capecitabine as the standard schedule.     The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from     50% (standard arm) to 20% (experimental arm). The investigators assume similar antitumor     activity in both arms.   "
196890|NCT00418041|"     Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study) is a     large, prospective, hospital-based cohort study to investigate the following:        -  Characteristics of patients with chronic heart failure and prognostic risks of these          patients.        -  Characteristics of patients with high risk for heart failure and critical factors which          predict the development of symptomatic heart failure in these patients.        -  The incidence and prognostic impact of metabolic syndrome in patients with chronic heart          failure.        -  The association between metabolic syndrome and the development of symptomatic heart          failure.   "
196891|NCT00418054|"     The purpose of this study is to evaluate the safety and efficacy of     nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy     in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide     monotherapy in the treatment of chronic hepatitis C.   "
196892|NCT00418067|"     The purpose of this study is to establish the safety and long-term effectiveness of coronary     stenting with the ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs.     the sirolimus-eluting balloon expandable stent (Cordis Johnson & Johnson, Warren, New Jersey)     and the paclitaxel-eluting stent (Taxus liberte, Boston Scientific) for the treatment of     coronary stenosis in routine clinical practice.   "
196893|NCT00418080|"     As clinical primary endpoints we assessed whether existed differences in:        1. PSA recurrence rate stratified according to treatment modalities        2. EGFR and HER2/neu overexpression rate stratified according to treatment modalities        3. PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.      As secondary clinical endpoints we assessed whether existed differences in:        1. prostate cancer-specific mortality according to treatment modalities        2. prostate cancer-specific mortality stratified according to EGFR and HER2/neu          overexpression levels.      For this purpose a post treatment PSA-doubling time of less than 3 months found following PSA     recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality     Pre-clinical endpoints As pre-clinical endpoint we assessed whether exist differences in     efficacy rate of Bicalutamide and Gefitinib treatment in primary tumor cultures stratified     for high and low EGFR and HER2/Neu expression levels. The evaluation of efficacy rate of     these treatments was documented by comparing the differences of drugs IC50 values among the     groups stratified for EGFR and HER2/Neu levels.   "
196894|NCT00418093|"     The main purpose of this study is to begin to collect information and try to learn whether or     not the combination of oxaliplatin, gemcitabine and bevacizumab works in treating women with     recurrent mullerian carcinoma. We will also collect more information about the safety and     side effects of this combination of drugs. Gemcitabine and oxaliplatin are chemotherapy drugs     that kill cancer cells. Bevacizumab is a new anti-cancer drug that works to slow or stop cell     growth in cancerous tumors by decreasing the blood supply to the tumors.   "
196895|NCT00418106|"     Kangaroo holding is a skin-to-skin method of holding a baby. Many research studies have     investigated the maternal and infant benefits associated with kangaroo holding. The purpose     of this study is to determine if kangaroo holding a baby changes the amount and composition     of breast milk pumped before and after the kangaroo holding session.      Hypotheses:        1. There is a significant difference in volume of maternal breast milk pumped after          kangaroo holding premature infants as compared to maternal breast milk pumped after          non-holding conditions        2. There is a significant difference in the composition of maternal breast milk pumped          after kangaroo holding premature infants as compared to maternal breast milk pumped          after non-holding condition.   "
196896|NCT00418119|"     Erythropoietin Treatment in Patients with systolic left ventricular dysfunction, mild anemia     and normal renal function   "
196897|NCT00418132|"     Progressive systemic sclerosis (SSc) is an immune-based disease that causes abnormal     connective tissue growth of the skin and internal organs. At this point, there are no     effective therapies for treating SSc. Thalidomide is a medication that has been shown to     stimulate an immune response that reduces the body's synthesis of collagen, the main     component of connective tissue. This study will determine the effectiveness of thalidomide in     treating adults with SSc.   "
196898|NCT00418145|"     This clinical trial compares the relative efficacy of treating acute exacerbations of     relapsing forms of Multiple Sclerosis with equivalent doses of oral and intravenous (IV)     methylprednisolone. This is a randomized, blinded, multi-center study.   "
196899|NCT00418158|"     Abstract: Post-operative pulmonary complications after cardiac surgery      Background The Catharina Hospital performs approximately 1700 heart operation each year. One     third of the patients stay at the Catharina hospital during their entire post-operative     period. Two years ago they abolished the pulmonary support by a physiotherapist.     Subjectively, the pulmonary complications increased over the last two years. During an     investigation of the contentment of the patients an increase of the pulmonary problems came     forward after eliminating the pulmonary support. There have been no further examinations to     the pulmonary complications post-operatively.      Objectives The aim of this study is to give the department of cardio-thoracic surgery an     advice about the post-operative pulmonary support for patients who underwent heart surgery.      During the study a budgetary analysis will be made.      Methods 120 patients are prospectively randomised in three groups. Randomisation takes place     through block randomisation every three weeks. 40 patients will be supported by a     physiotherapist. Another 40 patients will be supported by the nurses on the cardiothoracic     surgery ward and the last 40 patients will use an incentive therapy with 'Airlife' by a     self-management method.      The study population are all patients undergoing heart surgery and spend their entire     post-operative period at the Catharina Hospital. In- and exclusion criteria are specified in     the protocol on pages 3 and 4.      Outcome The primary outcome is to qualify the pulmonary complications within the three     groups. These complications will be objectified by measuring peak flow, an instrument to     determine the lung function, and an x-ray of the thorax.      The secondary outcome is the contentment of the patient, which will be determined by a     VAS-score (Visual Analogue Scale).      Risks There are no risks for the patient when participating on this study. The patient will     have to fill in the VAS-score and measure lung function with the peak flow at two different     moments. The study takes place in a clinical setting. There is no extra insurance in     conformity with the advice of the METC.   "
196900|NCT00418171|"     The primary objective of the study is to estimate the relative incidence among users of     ziprasidone and olanzapine of non-suicide mortality.   "
196902|NCT00418197|"     The Archus Total Facet Arthroplasty System® (TFAS®) is a non-fusion spinal implant indicated     for treatment of patients with moderate to severe spinal stenosis. TFAS® replaces the     diseased facets following surgical removal. TFAS® offers the surgeon new options for treating     spinal stenosis patients, enabling a more comprehensive decompression via complete removal of     the facets. TFAS® also offers an alternative to rigid spinal fusion fixation enabling     intervertebral motion. The clinical trial is intended to demonstrate restoration of stability     and sagittal balance to the spine. TFAS® also eliminates the need for painful bone graft     harvest from the patient's hip which may be required with fusion procedures.   "
196903|NCT00418210|"     Hypothesis:      In selected women with node-negative invasive breast cancer treated with breast conserving     surgery, postoperative accelerated partial breast irradiation (APBI) limited to the region of     the tumour bed delivered by 3-dimensional conformal radiation therapy (3D CRT) is technically     feasible and reproducible with acceptable treatment toxicity, cosmetic outcome, and local     control rate in a multicentre trial.   "
196904|NCT00418223|"     The purpose of this study is a systematical registration of ultrasound measurements and     urinary volume after catheterization. Based on these pairs of measurements we will calculate     the reliability of ultrasound compared with catheter volume.   "
196905|NCT00418236|"     It has been shown that women who have dense breasts have an increased risk of breast cancer     compared with women whose breasts are less dense. However, while breast density may be a risk     factor, the etiology of the relationship between breast cancer and breast density is not     understood. Furthermore, it is well recognized that breast cancer can still develop in women     whose breasts are not dense.      At menopause, the amount of breast glandular tissue and stroma naturally decreases due to a     lack of hormonal stimulation. This is characterized as a decrease in the mammographic     density. Although certain medications, including hormone therapy (HT) and dopamine     antagonists can increase breast density, these effects are reversible upon discontinuation of     the specific agent. Other medications such as the selective estrogen receptor modulators     (SERM), raloxifene (RAL) and tamoxifen, have been shown to not affect breast density and     allow the normal age-related changes to occur. The effects of bazedoxifene (BZA), a new SERM,     on breast density are not known. The purpose of this study is to examine the effect of BZA on     breast density changes over 24 months in postmenopausal women. The results may be useful for     clinicians to understand the effect of BZA on breast density and its mammographic effects.      This is an observational, multicenter, double-blind, randomized, placebo- and active     comparator-controlled study. It is also an ancillary that will use women who are already     participants in a phase 3 trial for fracture reduction (protocol 3068A1-301-WW; primary     study). In the primary study, subjects received BZA 20 mg, BZA 40 mg, RAL 60 mg, or placebo.     This ancillary study will request a subset of participants to use their mammograms taken in     this study. Their mammogram will be digitized by a central imaging center. A single     radiologist will perform the quantifications of breast density from the digitized mammograms.   "
196906|NCT00418249|"     The primary objective of this study is to assess the safety and efficacy of topical AS101 as     treatment for Female Androgenetic Alopecia (FAGA) in menopause women.   "
196907|NCT00418262|"     Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.   "
196908|NCT00418275|"     To evaluate the safety profiles of HTU-PA in patients with acute ischemic stroke.   "
196936|NCT00418639|"     This study will evaluate the effect of treatment with 24 weeks nitazoxanide monotherapy on     end of treatment virologic response, sustained virologic response, reduction of quantitative     serum HCV RNA, changes in ALT and safety parameters.   "
196909|NCT00418288|"     Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence     world wide with an increased risk of myocardial infarction and stroke. GLP-1 has convincing     effects on the high glucose levels in type 2 diabetic patients and is well tolerated. New     animal studies indicate a protective effect of GLP-1 in the brain and the heart. The     mechanism behind this is yet not known.      The study hypothesis is that during hypoglycaemia GLP-1 will stimulate glucose-uptake in the     brain and heart independent of insulin and thereby exert protective effects in the brain.   "
196910|NCT00418301|"     The primary objective of this study is to identify the brain regions in which activity is     affected by SCS. Baseline cerebral blood flow scans with the device turned off will be     generated compared to scans produced with the device operating at parameters which produce     optimal coverage of the painful areas. The relationship between cerebral blood flow and pain     rating scores will be evaluated in both conditions.   "
196911|NCT00418314|"     The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and     inter-ventricular (V-V) delay optimization using QuickOpt in patients with cardiac     resynchronization therapy device results in improved clinical response over standard of care     (i.e. empiric programming or one-time optimization using any non-intracardiac electrogram     optimization methods).   "
196912|NCT00418327|"     The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD)     of Tarceva in children as single agent and in combination with radiation therapy   "
196913|NCT00418340|"     Irritable bowel syndrome (IBS) is a common condition. At least 20% of the population suffer     from IBS. The symptoms of abdominal pain, diarrhoea, constipation, bloating and difficulty     with bowel motions are often disabling. Many of those affected are young and report a poor     quality of life (QOL) to a degree that is similar to gut inflammatory conditions like     ulcerative colitis and Crohn's disease. Yet the impact of IBS on patients' lives is often     underestimated. This is probably because unlike inflammatory bowel disease, in which the     bowel is inflammed and bleeds, the bowel in IBS looks normal. Instead the problem is of     abnormal functioning of the gut the cause of which is unknown.      Currently therapy for IBS is limited and until recently therapy has focused on treating the     symptoms to improve QOL primarily because the underlying mechanism of IBS is poorly     understood. However as more processes are being implicated in IBS e.g. visceral     hypersensitivity (excessive response to sensory stimuli within the gut), infection, immune     activation, dysmotility and abnormal gut fermentation , the potential for new therapies looks     promising. The evidence that gut bacteria play a role in inducing IBS symptoms is due to     observations of an improvement of IBS symptoms with probiotic therapy (bacterial supplements)     and antibiotic therapy.      Patients with IBS are hypersensitive to colorectal distension compared with healthy controls.     Studies carried out in our unit have shown that visceral pain thresholds in response to     stress are lower in patients with IBS compared with healthy volunteers. This hypersensitivity     is apparent in response to both a physical and chemical stimulus but the triggers to visceral     hypersensitivity remain largely unknown. Animal models suggest roles for both host immune     response and intestinal bacteria in the induction of visceral hypersensitivity. This proposal     will focus on further exploration of the mechanisms underlying visceral hypersensitivity to     direct future targeting of therapy.      Previous independent studies showed that (a) bacteria reduce visceral hypersensitivity,     (b)probiotic therapy can alter gut immune response and (c) gut sensation is affected by the     type of immune cells in the gut. Our research proposal will investigate the relationship     between gut bacteria, the immune system and the sensory gut nerves in order to understand how     IBS symptoms are generated. This understanding will be the critical for effective future drug     treatment.   "
196914|NCT00418353|"     Antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality     by specifically reducing the risk of respiratory distress syndrome, intraventricular     hemorrhage and neonatal death among premature infants. No human randomized study has formally     compared betamethasone and dexamethasone, the preferred corticosteroids for antenatal     therapy, with regards to their effectiveness in reducing neonatal morbidities and mortality.     Our objective was to compare betamethasone with dexamethasone in terms of effectiveness in     reducing perinatal morbidities and mortality among preterm infants.   "
196915|NCT00418366|"     A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes     medication   "
196917|NCT00418392|"     The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first     episode, and the optimal treatment remains unknown. In the recently published British     Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment     for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of     this procedure was as high as 25-30%, making it inappropriate as a standard of care.      Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way     to shorten the duration of air leaks and reduce the rates of recurrent spontaneous     pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline,     talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous     pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer     available. Talc insufflation of the pleural cavity is safe and effective for primary     spontaneous pneumothorax. However, it should be applied either with surgical or medical     thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in     inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional     minocycline pleurodesis is a safe and convenient procedure to decrease the rates of     ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In     the present study, additional minocycline pleurodesis will be randomly administered in     patients with first episode of primary spontaneous pneumothorax after simple aspiration to     test if it can reduce the rate of recurrence.   "
196918|NCT00418405|"     Rheumatoid arthritis is a relatively common autoimmune disease that affects about 1% of the     population. Its impact on health-related quality of life of the affected patients and the     national medical cost are enormous. However, a systemic prospective cohort study of     rheumatoid arthritis has not yet been established in Korea, so data on characteristics and     prognosis of Korean rheumatoid arthritis and their response to therapy and adverse events are     limited. Therefore establishment of large prospective cohort of Korean rheumatoid arthritis     is imperative.      With inauguration of a steadfast prospective cohort of Korean rheumatoid arthritis patients     in The Hospital for Rheumatic Diseases at Hanyang University, where patients gather from all     over Korea forming the largest and most diverse patient pool in Korea, we will be able to     define the characteristics and prognosis of Korean rheumatoid arthritis patients and gather     information on treatment response and adverse events. This will eventually lead to     improvement of health-related quality of life in Korean rheumatoid arthritis patients and     provide opportunity for reliable comparison study with research institutes from other     countries. The data gathered through the cohort will provide valuable foundational     information for the genetic studies, pharmacological economic analyses, and standard     treatment guidelines of Korean rheumatoid arthritis patients.   "
196937|NCT00418652|"     Trans Cranial Magnetic Stimulation (TMS) over dorsal visual system will disturb the ability     to identify objects with decreased level of fragmentation   "
196920|NCT00418431|"     Central serous chorioretinopathy (CSC) has been known since it was first described by Von     Graefe and termed “idiopathic detachment of the macula” in 1866, is a well-characterized     disorder leading to serous neurosensory elevation of the central macula. The acute form of     the disease is associated with focal leakage at the level of the retinal pigment epithelium     (RPE) demonstrated with fluorescein angiography (FA). The disorder is self-limited in the     majority of patients, who also regain excellent vision. Occasionally, the neurosensory     detachment persists and leads to pigment epithelial and photoreceptor damage with visual     impairment.      The purpose of this clinical study is report the use of intravitreal bevacizumab is a new     option in the treatment of the chronic or recurrent CSC.   "
196921|NCT00418444|"     The purpose of this study is to test an innovative intervention geared towards issues of     identity, body image and sexuality, and to examine the intervention for its impact on body     image, quality of life, psychosocial/sexuality/relational functioning.   "
196922|NCT00418457|"     In this multi-center trial, Stage 1-3 patients having mastectomies or isolated lumpectomy     with axillary node dissection will be randomly assigned to thoracic epidural or paravertebral     anesthesia/analgesia, or to general anesthesia and morphine analgesia. Participants will be     followed for up to 10 years to determine the rate of cancer recurrence or metastasis.   "
196923|NCT00418470|"     Patients with cystic fibrosis (CF) need to frequently undergo courses of IV antibiotic     therapy. To avoid a high number of venipunctures peripheral venous catheters (SPVC) or     cannulas are used. Because of the irritant action of the drugs used, SPVC's often do not last     for the whole antibiotic course (usually of two weeks) and the patient has to be punctured     again for the insertion of a new IV line. With the passing of time the veins are more     difficult to be found. An alternative to the use of a cannulas is the surgical insertion of a     central venous catheter. This intervention may have contraindications or, specially in     adolescents, cause unacceptable alterations of the body image.      The aim of this study is to find a way to prolong the duration of the SPVC used by CF     patients during antibiotic courses avoiding the irritation of the vein or a phlebitis.      Design of the study: randomized controlled trial. The study will see a collaboration of     nurses, physicians and technicians of the Tuscan CF Centre.      The patients that will participate at the study will be randomly assigned to one of the two     groups: one group will receive the antibiotics prescribed according to the maximal dilution     suggested by the pharmaceutical company, the other will receive a much higher dilution (i.e.     a higher volume of Normal Saline), but the time of administration will be the same.      The assessment will regard: the level of inflammation of the vein (with a special visual     scale) and the duration of the SPVC.      The hypothesis that is to be proved is that diluting the antibiotic in a higher volume of     Normal Saline it is possible to delay or prevent the irritation of the vein and the onset of     a phlebitis.      In case that the hypothesis will be confirmed by this study an easy, secure, low cost and     immediately available system will be available to reduce the number of venipunctures     necessary to complete a course of IV antibiotics.   "
196924|NCT00418483|"     The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus     Plasmin (Human) in acute peripheral arterial occlusion (aPAO). The ability of these Plasmin     doses to dissolve the clots will be estimated by arteriography.   "
196925|NCT00418496|"     The primary objective of this study will be to determine the toxicity and Maximum Tolerated     Dose (MTD) of the combination of high dose aldesleukin and sorafenib in previously untreated     patients with metastatic or unresectable clear cell renal carcinoma (RCC) and metastatic     melanoma.   "
196926|NCT00418509|"     This study will compare the performance of three combination metered dose inhalation devices     and the variability of mometasone and formoterol doses delivered to the lungs in a healthy     volunteer population   "
196927|NCT00418522|"     This study is to determine if inhaled insulin is effective in treating type 2 diabetes     mellitus.   "
198421|NCT00446485|"     The purpose of the study is to determine weather Ginkgo biloba standardized extract (24%     ginkoflavonoglicozides and 6% terpenes) is effective in treatment of cognitive and     concentration impairment   "
196928|NCT00418535|"     Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma     (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain     disease-free. The efficacy of the conventional anthracycline-based chemotherapy     (cyclophosphamide, doxorubicin, vincristine, prednisone [CHOPP]) has been unsatisfactory.      The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal     dose, sequence, and multi-modality treatment with involved field radiotherapy still need to     be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with     cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized     NK/T-cell lymphoma patients.   "
196929|NCT00418548|"     The purpose of this study is to compare efficacy, pharmacokinetics, and safety of     investigational formulations of etanercept administered as 50 mg once weekly with 25 mg twice     weekly and placebo in patients with ankylosing spondylitis (AS).   "
196930|NCT00418561|"     Objectives: The overall objective is to evaluate the safety, efficacy and pharmacokinetics     (PK) of rhASA treatment in patients with late infantile MLD.      Methodology: This is a single center, open-label study of patients with late infantile MLD.     Twelve patients will be enrolled in this study receiving a total of thirteen intravenous     infusions of Metazym. One infusion will be given every other week for a period of half a     year. After the half year the subjects will continue treatment every other week until safety     data is available. Safety (AE/SAE) will be monitored at every visit during this period.   "
196931|NCT00418574|"     The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an     experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms     of time the remission status is kept as well as prolongation of life expectancy.   "
196932|NCT00418587|"     The purpose of this study is to test the safety and effectiveness of different doses of     vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to     determine if vitamin D could be used as a treatment and/or preventative of SLE.   "
196933|NCT00418600|"     Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis     patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary     hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis     patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection)     is indicated for the treatment of secondary hyperparathyroidism in patients with chronic     kidney disease on dialysis.      This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol     capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will     enroll hemodialysis patients that have been controlled on intravenous Hectorol. the     information gained from this study will be a useful guide for physicians in managing CKD     Stage 5 patients for whom a change from intravenous to oral vitamin D administration is     appropriate.   "
196938|NCT00418665|"     This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG     531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects     with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are     planned to receive at least four cycles of lenalidomide for treatment of their disease are     appropriate to screen for this study.      All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by     mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a     week by subcutaneous injection for 16 weeks.   "
196939|NCT00418678|"     This is a Phase IV, open-label, sequential treatment study in patients who are receiving     standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer.     (See Section 4.2.1 for eligible treatment regimens.) The study will take place during the     first 2 cycles of chemotherapy.      Phase 1 of study:      Prior to the first dose of chemotherapy, patients will be instructed on how to complete their     patient diary, which will include a Visual Analogue Scale (VAS) for nausea and a VAS for     pain. In addition, the diary will include a section to list their current pain medications     (see Sample Patient Diary in Appendix I). After being instructed, patients will complete the     VAS for nausea and for pain, as well as listing their current pain medications. Patients will     then receive chemotherapy on Day 1 of Cycle 1 in combination with the pre-defined standard     serotonin antagonist/corticosteroid regimen.      Beginning on Day 2, the diary will be completed for 5 consecutive days (Days 2-6). Each day,     patients will complete a diary entry pertaining to the preceding 24 hours. The entry will     include the number and time of any emetic episodes, any antiemetic rescue medications used,     VAS for nausea, and side effects of treatment. On the last day of the diary (Day 6), the     entry will include the above daily parameters but will also include a VAS for pain. In     addition, the patient will complete a diary entry pertaining to the 5-day study period that     will include pain medications used. Patients will also complete the Functional Living Index -     Cancer (FLIC) questionnaire (see Sample Function Living Index - Cancer questionnaire in     Appendix II).      Patients who either have at least one vomiting episode or at least one report of significant     nausea (VAS > 25 mm) during the first 5-day study period will be eligible for the second     phase of the study.      Phase 2 of the study:      Patients in the second phase will receive a second cycle of the same chemotherapy. The     antiemetic regimen for the second cycle will be the same serotonin antagonist/corticosteroid     regimen as they received in Cycle 1, with the addition of Cesamet.      For Cycle 2 of treatment, patients will receive Cesamet 1 mg the night before chemotherapy is     to be administered. On the day of chemotherapy (Day 1 of Cycle 2), Cesamet 2 mg will be given     1 to 3 hours before the chemotherapy is administered, in addition to the same serotonin     antagonist/corticosteroid regimen as they received in Cycle 1. Patients will receive an     additional dose of Cesamet 2 mg the evening of Day 1.      Patients will receive Cesamet 2 mg BID on Days 2-5. Patients will complete the same 5-day     diary and FLIC questionnaire as they did in Cycle 1. Beneficial effects of Cesamet will be     estimated by comparing the results of the second cycle to the results of the first cycle.      Patients will be evaluated for the first 2 cycles of chemotherapy only.   "
196940|NCT00418691|"     Primary Objective:        -  To assess the efficacy of immediate release methylphenidate, sustained release          methylphenidate, and the novel vigilance enhancing drug modafinil for the improvement of          cognitive functioning in patients with brain tumors.   "
196941|NCT00418704|"     The purpose of this study is to determine duration before progression of first-line treatment     chemotherapy following erlotinib in second-line comparing erlotinib in first-line following     chemotherapy in second-line in old patients with none small cell lung cancer.   "
196942|NCT00418717|"     The primary purpose of this study is to evaluate the safety and efficacy of a once-weekly     dose of etanercept for rheumatoid arthritis. Currently, patients in Japan can only use 25 mg     etanercept two times a week. If a once-a-week regimen of 50 mg is approved, this would be     more convenient for most patients. This once-weekly regimen is used in countries outside of     Japan.   "
196943|NCT00418730|"     The purpose of this study is to measure the hair growth response to topical NEOSH101 when     applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with     Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will     participate. Three equally sized treatment groups (60 men each) will receive either topical     NEOSH101 2.0%, minoxidil 5%, or placebo.   "
196944|NCT00418743|"     The purpose of this study is to determine treatment efficacy and tolerability of second-line     treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy     with intravenous combination chemotherapy.   "
196945|NCT00418756|"     This study will evaluate the effect of 600 mg daily oral dose of rifampin (CYP3A4 inducer) on     the pharmacokinetics of a single 400 mg oral dose of nilotinib in healthy subjects   "
196946|NCT00418769|"     Bioavailability study comparing two new nilotinib tablet formulations to an established     nilotinib capsule formulation in healthy volunteers   "
196947|NCT00418782|"     CE-224535 is a new medication being developed as an analgesic and anti-inflammatory agent for     the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is     to evaluate the analgesic and anti inflammatory efficacy and safety of CE 224,535 versus     placebo and naproxen treatment in patients with OA knee pain.   "
196948|NCT00418795|"     A multi-centre, double-blind, randomized, placebo controlled, parallel group trial,     investigating the efficacy and safety of Porphozym (recombinant human porphobilinogen     deaminase)in the treatment of acute attacks in AIP.   "
196949|NCT00418808|"     Cerebral Palsy (CP) is a major developmental problem. Major risk groups of CP, are preterm     infants and multiple pregnancies. Previous studies using the General Movements methodology     demonstrated early identification of CP, as early as 3 month of age. This method was     implemented mainly on preterm infants this study goal is to enlarge the scope of the     methodology to infants of multiple pregnancies. A second goal is to study early motor     development and its future consequences by comparing the development of the infants of the     same multiple pregnancy.   "
196950|NCT00418821|"     The purpose of this study is to determine if laronidase is present in the breast milk of     post-partum women receiving Aldurazyme® (laronidase) and the effects of Aldurazyme     (laronidase) on the growth, development, and immunologic response of their breastfed infants.   "
196951|NCT00418834|"     A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at     high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given     in combination and two higher doses of atorvastatin on lipid lowering.   "
196952|NCT00418847|"     The purpose of the study is to investigate the pharmacokinetics of Zavesca (miglustat,     OGT918) when given as single and multiple doses in juvenile patients with GM2 gangliosidosis.   "
196953|NCT00418860|"     The purpose of this study to determine whether the dual antiplatelet therapy (aspirin and     clopidogrel) for 3 months after coronary implantation of zotarolimus-eluting stent is safe in     terms of death, myocardial infarction, or stent thrombosis.   "
196954|NCT00418873|"     The purpose of this study is to compare the efficacy and tolerability of zotepine versus     Risperidone in aggressive schizophrenic patients.   "
196965|NCT00426855|"     The purpose of this study is to determine whether the combination of bendamustine and     bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia     is safe and tolerable.   "
196966|NCT00426868|"     The purpose of this study is to establish safety and feasibility of utilizing Adipose Derived     Stem & Regenerative Cells (ADRCs) in patients who have areas of myocardium that are not     revascularizable and have demonstrated reversible ischemia.   "
196955|NCT00418886|"     Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop     them from dividing, or stop the growth of the blood supply that cancers need to grow and     spread. Clinical research has shown that drugs that inhibit vascular endothelial growth     factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase     overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical     studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR     signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking     their blood supply and by stopping them from dividing. This lung cancer study is to     investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta     (pemetrexed) alone.   "
196956|NCT00418899|"     The goal of this research study is to investigate the role of genes that may point to a     higher risk of developing a glioma. Researchers will use new gene mapping techniques to study     how high-risk factors are passed on through a family's genes and increase the risk of     developing gliomas.      Objectives:      We propose an international multi-center, multidisciplinary study consortium, GLIOGENE, to     identify susceptibility genes in high-risk familial brain tumor pedigrees using the most     sophisticated genetic analysis methods available. To address our hypothesis, we propose the     following specific aims:      Aim 1: Establish a cohort of 400 high-risk pedigrees for genetic linkage analysis. To date,     we have identified and collected biologic samples from 20 high-risk families that have met     our criteria of 2 or more relatives diagnosed with a brain tumor. From the 15 centers in the     United States and Europe, we will screen and obtain epidemiologic data from approximately     17,080 gliomas cases to identify a target of 400 families for genetic analysis. We will     establish a cohort of the first and second-degree relatives from these glioma cases to obtain     new knowledge about how cancer aggregates in glioma families. We will also acquire     biospecimens (blood and tumor tissue), and risk factor data from relevant family members.      Aim 2: Identify candidate regions linked to familial brain tumors. To strengthen evidence of     linkage to regions found in our preliminary analysis and to identify additional regions     linked to brain tumors, we will genotype informative glioma pedigrees identified in aim 1     using Affymetrix 10K GeneChip with markers spaced throughout the genome, and conduct a     genome-wide multipoint linkage scan with these markers.      Aim 3: Fine map the regions established in Aim 2 by genotyping selected SNPs from genome     databases. We will attempt to further refine the regions identified in Aim 2 to less than 1cM     by using approximately 1,500 - 2,000 carefully selected SNPs. The prioritization of regions     will be based on a combination of the strength of evidence for linkage from families of     various ethnic backgrounds and the presence of obvious candidate genes.   "
196957|NCT00418912|"     Schizophrenia is a severe mental illness which is considered to have, among other, a genetic     etiology. One of the most efficient tools in genetic-psychiatry is the investigation of     multiplex families.      The current study will identify patients of multiplex families and to map their family     connections and the presence of mental illnesses among family members.   "
196958|NCT00418925|"     Cervical dystonia (CD) is characterized by abnormal, involuntary sustained cervical muscles     contractions associated with twisting movements and abnormal postures of the neck that can be     quite disabling. Currently there are no good oral medications for the treatment of CD. While     botulinum toxin injections are effective in most, they require repeat injections and there     are some patients who either stop responding or who never respond at all. Therefore, better     treatments are needed. While the underlying mechanisms of dystonia are not entirely known,     there is some information suggesting that it is ude to an underactivity of a chemical     compound, GABA, that is located in the basal ganglia. Cannabinoids are a compound than can     enhance transmission of GABA, and thus, may alleviate the symptoms of dystonia. Dronabinol,     one such cannabinoid, has been widely used to treat anorexia and nausea in chemotherapeutic     patients. The aim of this study, therefore, is to study the effect of dronabinol on cervical     dystonia   "
196960|NCT00426790|"     The hypothesis of this study is that the Open lung approach ( recruitment and PEEP) during     general anaesthesia reduces atelectasis formation and improves respiratory function in the     immediate post-operative period after major abdominal surgery.      This is a prospective, randomized, controlled clinical-trial,performed in patients undergoing     major abdominal surgery, to compare the effects on the post-operative pulmonary complications     of two different intraoperative ventilatory strategies during general anaesthesia: 1- Control     Group: PEEP 0 cmH2O without recruitment manoeuvre; 2- Treatment Group:recruitment manoeuvre     (after intubation and before extubation) and PEEP 10 cmH2O In the post-operative period the     following variables will be recorded at the first, third and fifth postoperative day: 1-     Gas-exchange in air; 2- Chest X-ray for atelectasis evaluation; 3- signs of pulmonary     complication (cough, secretions, dyspnea, thoracic pain)   "
196961|NCT00426803|"     This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study     is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute     intracerebral bleeding.   "
196962|NCT00426816|"     This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity,     PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects     with primary insomnia   "
196963|NCT00426829|"     Primary Objectives:        1. To evaluate the safety of the treatment of patients with technically or medically          inoperable hepatocellular carcinoma and cholangiocarcinoma with proton therapy and          concurrent bevacizumab biotherapy.        2. To identify the maximum tolerated dose (MTD) using this combination.      Secondary Objectives:        1. To evaluate local control rate within the radiation field, hepatic control rate outside          the treatment field, time to radiographic progression and 2 year survival rate.        2. To analyze dose-volume characteristics that influence the development of radiation          induced liver disease (RILD) and GI bleeds that may occur.        3. To assess quality of life during and after chemoradiation therapy.   "
196964|NCT00426842|"     With upright postures, there is an immediate redistribution of blood to the dependent     circulation; venous return and central venous filling pressure are reduced, resulting in     diminution of cardiac output and blood pressure. These hemodynamic alterations stimulate the     baroreceptor reflex, which is mediated via the central nervous system to increase peripheral     sympathetic vasomotor tone, restoring blood pressure and cardiac output within     seconds-to-minutes of the assumption of the upright position. Following SCI, individuals     often experience the inability to adjust to postural changes due to disruption of central     command of the baroreceptor reflex and reduction in efferent sympathetic neural pathways;     consequently, orthostatic hypotension (OH) and symptoms of cerebral hypo-perfusion may ensue.     OH is a well-documented phenomenon, which is characterized by a fall in systolic blood     pressure of >20 mmHg or diastolic BP of > 10 mmHg within 3 minutes of assumption of an     upright posture. As a consequence of OH, many individuals experience symptoms of cerebral     hypo-perfusion which include lightheadedness, dizziness, blurry vision, fatigue, nausea,     ringing in the ears, cognitive impairment and heart palpitations. Although several     investigators have reported increased prevalence of OH during the acute phase of spinal cord     injury (SCI), individuals with chronic injury also experience significant falls in blood     pressure with seated upright postures. This investigation will examine the effects of an     alpha-agonist, midodrine hydrochloride, during head-up tilt on systemic blood pressure,     cerebral blood flow and cerebral oxygenation compared to placebo administration in persons     with chronic SCI who demonstrate significant orthostatic hypotension during a 24-hour     observation study. This is the first study to determine the dose response and efficacy of     midodrine to improve orthostatic blood pressure and cerebral blood flow and oxygenation in     the SCI population.   "
196967|NCT00426881|"     Primary Objectives:      1. To ascertain whether a 12-month, twice-weekly or once-weekly resistance training (RT)     program will significantly improve executive function in community-dwelling women aged 65 to     75 years old compared with a 12-month, twice-weekly stretch and relax (S & R) program (shame     exercise). We will assess executive function by standard neuropsychological tests.      Secondary Objectives:        1. To describe the neural mechanisms that underpin the observed changes in executive          function associated with a 12-month, twice-weekly or once-weekly RT training (by using          functional magnetic resonance imaging (fMRI)).        2. To investigate whether RT-induced changes in executive function are independently          associated with changes in physiological fall risk profile.        3. To investigate the dose response of RT (resistance training) on bone health as measured          by dual energy x-ray and peripheral quantitative computed tomography.        4. To conduct a one-year follow-up after the formal cessation of the resistance training          programs to determine the persisting effect of resistance training on cognitive          performance, cortical plasticity, physiological falls risk, and bone health.   "
196968|NCT00426894|"     the purpose of this study is to determine whether children who are hospitalised waiting for     cardiac surgery for several days in pediatric or pediatric surgery department acquire     resistant microbial flora, thus necessitating broad spectrum antibiotics for perioperative     prophylaxis.   "
196969|NCT00426907|"     In this project we want investigate the clinical results after different rehabilitation     regimens(Limited or unlimited weightbearing after surgery) in Open-wedge High Tibial     Osteotomies.      The hypothesis is that unlimited weightbearing is beneficial for the healing and     rehabilitation.   "
196970|NCT00426920|"     Evaluation of the pharmacokinetics and pharmacodynamics of different doses of spray-dried     recombinant human insulin powder for inhalation administered via a dry powder uinhalation     device compared with subcutaneously administered regular human insulin in healthy male     volunteers under the conditions of a eugycemic clamp.   "
196971|NCT00426933|"     multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of     HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for     7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized     on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g.     q12h for up to 14 days.   "
196972|NCT00426946|"     The aim of the present study is to prospectively assess the anti-depressant effectiveness of     reboxetine in children and adolescents, as compared with fluoxetine, in a randomized     controlled open-label trial.   "
197092|NCT00428740|"     Long-term intraocular pressure (IOP) fluctuation may be significantly associated with the     progression of glaucomatous visual field loss, even in patients kept always low IOP after     triple procedure, an effective approach for patients with coexisting glaucoma and visually     significant cataracts.   "
196973|NCT00426959|"     This will be a phase I study. This phase I study is not a standard drug dose escalation     study, but rather a Clinical System Performance Evaluation Trial of a therapeutic device.     However for purposes of this protocol we will refer to this portion of the trial as a phase I     study.      The purpose of this study is to demonstrate the feasibility and clinical practicability of     the registered ultrasound and fluoroscopy (RUF) in combination with CMS Interplant system® in     an initial cohort of 6 patients.      This will involve demonstrating the feasibility of using the system in an actual operating     room environment as well as obtaining a preliminary assessment of the accuracy and     performance of the source location algorithm by comparing with postoperative CT dosimetry.      The Primary endpoint of this study will be evaluation of the feasibility of using the RUF     system and of performing real-time optimization in the operating room environment.      The Secondary endpoints of this study will be:        1. Acute and late toxicity as assessed by IPSS, SHIM, and EPIC questionnaires at multiple          follow-up intervals.        2. PSA-free survival.      Study Population:      The target population will be patients with a diagnosis of adenocarcinoma of the prostate who     are seen in consultation at the Johns Hopkins Hospital.      Approximately 360 patients per year with the diagnosis of prostate cancer are seen in the     Department of Radiation Oncology at Johns Hopkins Hospital. Of these patients, approximately     45% have low-risk (T1a-T2a, Gleason 6 or less, PSA 10 ng/ml or less) or intermediate-risk     disease and are suitable for brachytherapy based on disease risk. Within this group of     patients, approximately 70% are eligible for brachytherapy based on gland size and no prior     transurethral resection of prostate (TURP).      Approximately 80% of patients offered brachytherapy at consultation decide to receive their     treatment at Johns Hopkins. Overall, we currently perform 2 brachytherapy procedures per week     on average, for a yearly total of approximately 90 cases.      For purposes of homogeneity of treatment and patient population, this protocol will only     enroll patients currently treated at this institution with brachytherapy alone, and will not     enroll patients (intermediate or high risk disease) who will require external beam radiation     in addition to brachytherapy.   "
196974|NCT00426972|"     This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness     skin graft donor sites in patients aged 18-85 years.   "
196975|NCT00426985|"     The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain     associated with tendonitis or bursitis of the shoulder, elbow or knee   "
196976|NCT00426998|"     The purpose of this research study is to compare different timing therapies of Verteporfin     with Bevacizumab to treat choroidal neovascularization (CNV) due to age-related macular     degeneration (AMD).   "
196977|NCT00427011|"     Phase IIb open-label extension study for patients with Parkinson's Disease. All patients will     receive active study drug. The study will involve outpatient visits only. Patients who     completed Study E2007-A001-214 (Cohorts I and II) and who meet inclusion/exclusion criteria     will be enrolled and enter the 12-week Titration Phase (from Dispense Study Drug at Week 0     [Visit 2] through Week 12 [Visit 7]) followed by the Maintenance Phase (from Week 12 [Visit     7] to end of study).   "
196978|NCT00427024|"     Previous studies in animals revealed, that the activity of certain transporters along the     nephron is changed with acute rejection after renal transplantation. We intend to investigate     underlying mechanisms occurring in man in renal biopsy specimens obtained from patients     because of acute rejection of the transplant or chronic transplant nephropathy.   "
197000|NCT00427492|"     Randomised doublet blinded study of the effect of tablet Magnesia (laxative) on post     operative bowel ileus after open colonic resection. Material: 56 patients in two equal     groups. Primary endpoint: Bowel function. Secondary endpoints: Intake of food and drinks.   "
197001|NCT00427505|"     This is a study to investigate the pharmacokinetics of deferasirox   "
197002|NCT00427531|"     RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using     a skin conduction device or by using a diary.      PURPOSE: This clinical trial is studying a skin conduction device and a patient diary for     measuring hot flashes in postmenopausal women with hot flashes.   "
197485|NCT00432731|"     Primary objective:      To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first     single dose injection in 12 to 15 month-old infants in the 42-day follow-up period     post-vaccination.      Secondary objectives: NA   "
196979|NCT00427037|"     This is a 12 week pilot and feasibility study with an enrollment goal of 30 subjects. Half of     the subjects will be randomized to vitamin D3 and the other half will receive a placebo.     Subjects will be referred from the nutrition or renal clinic at Emory. CKD stage 3 and 4     patients will be eligible for participation if they have been determined to have vitamin D     deficiency and are not on treatment with vitamin D or vitamin D analogues. Subjects will sign     an informed consent form after reviewing the protocol in detail with the principal     investigator. A questionnaire would collect information about dietary vitamin D intake,     sunlight exposure, and any symptoms of vitamin D deficiency. The subject will have baseline     levels of serum vitamin D (25-hydroxyvitamin D), parathyroid hormone (PTH), serum calcium and     phosphate, creatinine and other markers of bone turnover. The questionnaires and the blood     draws would be repeated on the 6th and 12th week of the study. Subjects will be given 12     pills of each containing either 50,000 IU vitamin D or placebo and asked to take one pill a     week. They would be scheduled to return to the clinic after 6 weeks and blood measurements     would be repeated. Subjects will be asked to revisit for their final visit at the 12th week     when they would have their last blood draw and assessment.   "
196980|NCT00427050|"     The purpose of this study is to determine the optimal tolerated regime of PEP005 for the     treatment of actinic keratoses of the face or face and scalp.   "
196981|NCT00427063|"     The purpose of this study is to asses the relative influence of genetic and environmental     influence on the tortuosity of retinal arterioles in eyes of 218 healthy Danish twins aged     20-46 years. We expect to find a high heredity for the variation in tortuosity. This     knowledge can contribute to the elucidation of the pathology in retinal diseases.   "
196982|NCT00427076|"     Methicillin-resistant Staphylococcus aureus (SA) is a major pathogen causing mainly     health-care associated infections and, lately, also community acquired infections. Few     treatment choices exist to treat these infections. The currently recommended antibiotics for     these infections are glycopeptides (vancomycin or teicoplanin). Glycopeptide treatment hs     several disadvantages. It is a last resort antibiotic family that should be reserved for the     future; Vancomycin is less effective that beta-lactam drugs for SA infections susceptible to     both agents; treatment can only be given intravenously; and use of vancomycin has led to the     development of SA strains with partial or complete resistance to vancomycin. Cotrimoxazole is     an old antibiotic active against most strains of MRSA, depending on local epidemiology.      Study hypothesis: The purpose of this study is to show that cotrimoxazole is as effective as     treatment with vancomycin for invasive MRSA infections.      We plan a randomized controlled trial comparing treatment with cotrimoxazole vs. vancomycin     for invasive MRSA infections. The primary efficacy outcome we will assess will be Improvement     or cure with or without antibiotic modifications, defined as: survival at 7 days post     randomization with resolution of fever (<38 for two consecutive days) and resolution of     hypotension (>90 systolic without need for vasopressor support); and physician's assessment     that the primary infection was improved or cured. The primary safety outcome will be     all-cause 30-day survival.   "
196983|NCT00427089|"     To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution     (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening     colonoscopies   "
197120|NCT00429104|"     Primary Objectives:        1. To determine the patient's tumor response rate that this protocol will produce.        2. To determine the 1 year progression-free survival that this protocol will produce.      Secondary Objective:      1. To determine whether antibody-dependent cell-mediated cytotoxicity (ADCC) is the mechanism     of overcoming Herceptin-resistance by use of Granulocyte-Macrophage Colony Stimulating Factor     (GM-CSF).   "
198422|NCT00446498|"     To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema     treated with CPAP or NPPV.   "
196984|NCT00427102|"     Rationale for Study      Oral mucositis is a major complication arising from contemporary chemoradiation treatment of     patients with head and neck cancer.      No effective therapy exists to prevent this complication in this population. MRX-1024 is an     investigational agent that has demonstrated in in vitro and in vivo experiments to have the     potential to exert a protective effect in normal mucosa cells, without interfering with the     intended antitumor effect of radiation.      A pilot Phase 1 study of MRX-1024 was conducted in India in patients with head and neck     cancer receiving radiation alone or radiation in combination with cisplatin or carboplatin.     MRX 1024 doses of 100 mgkg given orally twice a day, five days a week during radiation     treatment cycles, were well tolerated and appeared to exert a protective effect against the     development of severe mucositis.      Twice daily doses of MRX 1024 impose a certain level of inconvenience to the patient, to     their clinic companion, and to the general work flow within radiation oncology clinics.      This study is designed to study the safety and pharmacokinetics of both single daily dose and     twice daily dose regimens of oral MRX 1024 given in conjunction with daily radiation     fractions and intermittent high-dose cisplatin to patients with high-risk for recurrence head     and neck cancer following surgical resection. The study will also document the incidence and     severity of oral mucositis that occurs following such therapy. The results will be     instrumental in determining the regimen of MRX 1024 to use in subsequent definitive clinical     trials.   "
196999|NCT00427479|"     An increasing number of people have an allergy to birch pollen, which manifests itself as     Springtime hayfever. Some will also have cross-reactions to fruits, vegetables and nuts, a     condition known as Oral Allergy Syndrome (OAS). Research has demonstrated that the most     effective method of diagnosing this problem is by taking a good clinical history and     performing skin prick tests using fresh foods.      The aim of the study will be therefore to investigate the prevalence of OAS in a     birch-sensitive population using a simple screening tool and establish the range of foods     involved. The objective will be to maximise effective treatment for the patients in our large     respiratory allergy clinic by using the screening tool to identify patients with OAS and     advise them on the usual foods involved. A further objective will be to use the data to     discover if there are any patterns of particular foods involved in OAS in UK sufferers.      The study hypotheses are therefore that there is a high prevalence of oral allergy in people     with birch pollen allergy; the best way of diagnosing the problem is by using a screening     tool and that there is a core set of foods that are commonly involved in OAS in patients seen     in the allergy clinic.   "
197526|NCT00433290|"     The primary purpose of this study is to determine if duloxetine reduces pain severity in     patients with osteoarthritis knee pain.   "
196985|NCT00427297|"     Globally, children who acquire HIV-1 increasingly do so in the context of maternal     antiretroviral prophylaxis. It is important to determine whether maternal antiretroviral     prophylaxis should alter infant treatment regimens. Nevirapine (NVP) is commonly used for     PMTCT and is also a commonly used first-line drug for treatment of pediatric HIV-1.     Approximately half of infants exposed to NVP have detectable NVP resistance early in infancy,     with loss of detectable resistance over time. Thus, if an HIV-1 infected child was exposed to     single-dose NVP prophylaxis, the question remains whether NVP or any NNRTI can be used     effectively in therapeutic regimens. Alternative PI-based regimens are associated with     heat-lability, poor palatability, cumulative toxicity, and fewer salvage options. This poses     challenges for pediatric PI-based highly active antiretroviral therapy (HAART) in settings     without refrigeration and limited antiretroviral repertoire. It is plausible that in older     NVP-exposed infants (older than 6 months since exposure) who are genotypically     NVP-susceptible, that nevirapine will be effective and useful.      We propose to study resistance in a pediatric HIV-1 clinical trial involving 100 children.     Among children enrolled at between 6 and 18 months of age, we will provide real-time     field-based genotypic NVP-resistance testing, and randomize 100 NVP-susceptible children to     NVP-containing versus NVP-sparing HAART to compare therapeutic response, adverse events, and     morbidity in the 2 arms during 2-year follow-up. Follow-up in these studies will be closely     monitored by an external Data Safety and Monitoring Board (DSMB).   "
196986|NCT00427310|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing. It     is not yet known whether giving fluorouracil into the liver is more effective than no further     treatment for patients with colon cancer undergoing surgery.      PURPOSE: This randomized phase III trial is studying giving infusions of fluorouracil into     the liver in treating patients with Dukes' A, Dukes' B, or Dukes' C colon cancer undergoing     surgery.   "
196987|NCT00427323|"     The purpose of this study is to test whether shifts in the timing of the biological clock to     a later hour (phase delay shifts of the human circadian system) can be produced in response     to four successive evenings of light exposure, and whether that phase shift will result in     greater evening alertness and greater nighttime sleep efficiency. Three different light     sources will be compared: 1) standard fluorescent light; 2) blue-enriched light; 3)     incandescent fluorescent light.   "
196988|NCT00427336|"     Primary Objectives:        1. To determine the feasibility and toxicity of employing purine-analog based conditioning          for allogeneic donor stem cell transplantation in patients with severe aplastic anemia          (AA).        2. To determine the engraftment kinetics and degree of chimerism that can be achieved with          this strategy.   "
196989|NCT00427349|"     RATIONALE: AMG 706 and octreotide may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well AMG 706 and octreotide work in treating     patients with low-grade neuroendocrine tumors.   "
196990|NCT00427362|"     To further assess the safety and effectiveness of adalimumab 40mg in the treatment PsA who     have had an unsatisfactory response or intolerance to prior or ongoing DMARDs   "
196991|NCT00427375|"     Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5     weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised     in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the     rate of patients with death, recurrence, major morbidity or severe after effects at two     years.   "
196992|NCT00427388|"     SIRS trial is a large simple study in which high-risk patients undergoing cardiac surgery     requiring the use of cardiopulmonary bypass (CPB) are randomly allocated to receive a pulse     dose of Methylprednisolone or a matching placebo. Cardiopulmonary bypass initiates a systemic     inflammatory response that facilitates development of post-operative complications. SIRS will     confirm or deny the potential clinical benefits of suppressing this response through the use     of systemic steroids. Specifically, does 250 mg of intravenous Methylprednisolone given     twice, once on anesthetic induction and again on CPB initiation, result in improved early     survival and less myocardial infarction in high-risk cardiac surgery patients requiring CPB?   "
196993|NCT00427401|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and     pharmacodynamics (PD) of PF-00915275 following administration to adult human subjects with     T2DM for 4-weeks. The primary end point is glucose lowering (24 hour mean glucose     concentration).   "
196994|NCT00427414|"     RATIONALE: Drugs used in chemotherapy, such as liposomal daunorubicin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.      PURPOSE: This clinical trial is studying how well liposomal daunorubicin works in treating     patients with HIV-related Kaposi's sarcoma.   "
196995|NCT00427427|"     The purpose of the study is to determine what factors affect a patient's decision to accept     delayed Herceptin® treatment after completing their surgery and/or chemotherapy and/or     radiation therapy.      Women with invasive breast cancer that have a HER-2 positive (FISH +) determination in 2004     or thereafter and who have completed surgery and primary treatment earlier will be     potentially eligible.      Patients will be asked to complete a questionnaire about their breast cancer and reasons why     they may or may not accept Herceptin® treatment. Patients will be given the option to (1)     receive Herceptin® for 52 weeks and have annual doctor visits for 5 years or (2) not to     receive Herceptin® but agree to annual doctor visits for 5 years.   "
196996|NCT00427440|"     The purpose of this study is to evaluate the effectiveness and safety of AMG 102 for the     treatment of Advanced Malignant Glioma.   "
196997|NCT00427453|"     This is a phase I study to test the immunogenicity of a recombinant vaccine based on Modified     Vaccinia Ankara (MVA) expressing the antigen 85A (from Mycobacterium tuberculosis). This     vaccine is delivered intradermally by a needle injection in healthy volunteers previously     vaccinated with BCG.   "
196998|NCT00427466|"     The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed in     patients with metastatic soft tissue sarcoma who have progressed after or during an     anthracycline-based chemotherapy and to assess the toxicity profile   "
197051|NCT00428181|"     The purpose of this study is to determine whether a booster session is needed after a brief     intervention upon initial admission to the emergency room (ER) in order to reduce the rate of     alcohol-related injury recidivism.   "
197003|NCT00427544|"     The primary purpose of this study is to asess the safety and tolerability of ascending single     oral doses of PRA-027 in healthy women of nonchildbearing potential. The secondary purpose is     to provide the initial pharmacokinetic (PK) and pharmacodynamic (PD) profile of PRA-027 in     healthy women of nonchildbearing potential, and to evaluate the effect of a high-fat meal on     the PK and PD of PRA-027 administered to healthy women of nonchildbearing potential.   "
197004|NCT00427557|"     The goal of this clinical research study is to learn if giving umbilical cord blood along     with standard stem cells after high-dose chemotherapy will improve the response to a stem     cell transplant. The safety of this treatment will also be studied.   "
197005|NCT00427570|"     RATIONALE: Drugs used in chemotherapy, such as vincristine, fluorouracil, and semustine, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Biological therapies, such as BCG, may stimulate the immune     system in different ways and stop tumor cells from growing. It is not yet known whether     combination chemotherapy is more effective than BCG in treating colon cancer that has been     removed by surgery.      PURPOSE: This randomized phase III clinical trial is studying giving fluorouracil together     with semustine and vincristine to see how well they work compared with giving BCG in treating     patients with Dukes' B or Dukes' C colon cancer that has been removed by surgery.   "
197006|NCT00427583|"     This study assesses the safety and efficacy of imatinib mesylate treatment of patients with     malignant peripheral nerve sheath tumors   "
197007|NCT00427596|"     This is a two-part study. Part 1 is designed to find the best modified release formulation of     GW423753; Part 2 is designed to use the selected formulation(s) from Part 1 to find out if     food affects the way the medication is processed by the body.   "
197008|NCT00427609|"     The purpose of this study is to determine the efficacy for Bicillin L-A, administered     intramuscularly in a dose of 2.4 million units every three (3) weeks, for the treatment of     chronic, plaque-type psoriasis unresponsive to topical medications or when other systemic     therapies are contraindicated.   "
197009|NCT00427622|"     RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using     a skin conduction device or by using a diary.      PURPOSE: This clinical trial is comparing a skin conduction device with a hot flash diary as     a way of measuring hot flashes in postmenopausal women with hot flashes.   "
197010|NCT00427635|"     The purpose of this study is to assess the difference between esomeprazole and placebo in the     treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring     in neonatal patients.   "
197011|NCT00427648|"     The purpose of this study is to determine whether alkalized lidocaine instilled into the     bladder is effective in the treatment of overactive bladder (OAB).   "
197148|NCT00429481|"     To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different     concentrations) in healthy infants aged approximately 3 months previously uninfected with     human rotavirus.   "
197382|NCT00430079|"     This clinical trial is using EF5 to measure the oxygen level in tumor cells of patients     undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma.     Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help     in planning cancer treatment   "
197012|NCT00427661|"     Hypothesis 1: A novel nonmyeloablative condition regimen will be safe and efficacious in     producing stable donor chimerism and cure of severe hemoglobinopathy.      Hypothesis 2: Stable donor chimerism will result in amelioration of cerebral vasculopathy,     improved cerebral perfusion and neurocognitive function.      Specific Aim 1: Study the safety and efficacy of a novel non-toxic conditioning regimen for     HSCT for patients with severe hemoglobinopathies and the kinetics of lineage specific     chimerism after HSCT      We will test our hypothesis that a novel nonmyeloablative condition regimen will be safe and     efficacious in producing stable donor chimerism and cure of severe hemoglobinopathy:      Specific Aim 2: Optimize the immunosuppressive regimen for HSCT patients through a thorough     understanding of the pharmacokinetics of Busulfan (BU) and mycophenolate mofetil (MMF) in the     patient population. This will involve:        1. Determine the pharmacokinetics of intravenously and orally administered MMF and          intravenous BU in patients receiving HSCT.        2. Determine the relationship of Area under the curve (AUC) of BU and mean trough          concentrations of mycophenolic acid (MPA) to engraftment and graft versus host disease          (GVHD).        3. Determine the relationship of Area under the curve (AUC) and steady state concentration          of BU to engraftment at day 30 and 1 year post HSCT.      Specific Aim 3: Study the effect of complete or partial donor chimerism on silent and overt     cerebral vasculopathy, and neurocognitive functioning in patients with SCD undergoing HSCT.     We will test our hypothesis that stable donor chimerism will result in improvement in     cerebral vasculopathy and neurocognitive function. This will include.        1. Determine effect of transplantation silent and overt cerebral vasculopathy by comparison          MRA and TCD 1 year after HSCT to pre-HSCT studies.        2. Determine effect on HSCT on neurocognitive function. Specific Aim 4: To determine the          rate of T cell immune reconstitution in children with sickle cell disease following          myeloablative compared to nonmyeloablative stem cell transplantation, using          immunophenotyping assays, CDR3 spectratyping TREC analysis, and measurement of T cell          specific donor engraftment.   "
197013|NCT00427674|"     The overall plan of this project is to evaluate [123I] mZINT as a tool to assess SERT density     in humans. This protocol will be completed in three parts. In Part A serial dynamic SPECT     will be acquired after injection of [123I] mZINT in healthy controls to assess regional brain     uptake in human subjects. If Part A demonstrates robust brain region specific uptake, then     Part B - additional studies in healthy subjects to assess biodistribution, and Part C -     studies in PD subjects to compare regional uptake to healthy controls, will be completed.   "
197014|NCT00427687|"     This study will evaluate the effect of AGG-523 administration on biomarkers related to     osteoarthritis. Safety and tolerability of AGG-523 will also be assessed.   "
197015|NCT00427700|"     The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems.     Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has     a detrimental effect over uterine receptivity.      Raloxifene is a Selective Estrogen Receptor Modulator, that does not have a detrimental     effect over the endometrium, and also increase the serum levels of FSH, thus, inducting     ovulation.      The objective of this study is to compare the ovulation rate in PCOS patients between     clomiphene citrate and raloxifene in a double blind randomized trial.   "
197016|NCT00427713|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells     that remain after surgery. It is not yet known whether giving capecitabine together with     oxaliplatin is more effective than standard follow-up care in treating rectal cancer that was     removed by surgery.      PURPOSE: This randomized phase III trial is studying capecitabine and oxaliplatin to see how     well they work compared with standard follow-up care in treating patients who have undergone     surgery for locally advanced rectal cancer.   "
197527|NCT00433303|"     The purpose of our study is correlate between premature delivery (between week 23-35 of the     pregnancy) in women that had intercourse up to 12 hours prior to beginning of labor and     polymorphisms in the gene Prostanoid receptor.   "
197017|NCT00427726|"     This study will provide follow-up evaluations of breast cancer or multiple myeloma patients     who received gene therapy (gene transfer) as part of their participation in an NIH protocol.     Gene therapy is a new technology, which may involve a permanent change in the patient s     genetic code. Therefore, although the risk of long-term harmful effects of this therapy is     very small, the Food and Drug Administration requires prolonged monitoring of patients health     status.      Patients previously enrolled in NIH protocols 96-C-0007, 93-C-0208, 92-C-0161, or 92-H-0057     will be followed under the current protocol. No further gene therapy will be provided in this     study.      Patients health status will be evaluated for an indefinite period of time, or as long as they     are willing to be monitored. They will provide a blood sample once a year and will be     interviewed about their health status twice a year for the first 5 years after gene therapy     and once a year thereafter. These procedures are done to look for the development of any     diseases such as cancer, neurological disorders, autoimmune or blood disorders that may be     related to side effects of the gene transfer.   "
197018|NCT00427739|"     At present, there is not accurate way to determine specific flow rates for axial flow     ventricular assist devices (VADS). If a right heart cath is needed for these patients for     clinical purposes, they will also undergo a cardiac CT scan while the pulmonary artery     catheter is in place. It is possible to visualize the flow rates of axial flow VAD's and     determine a more accurate rate per specific patient.      Data Analyzed with following results:      Article in Press for Cardiopulmonary Support and Physiology, results state Pairwise     comparison of calculated output from left ventricular assist devices is feasible using first     pass dynamic computed tomography test bolus technique versus thermodilution output     measurements yielded good agreement (P=.03). The output calculated using dynamic CT     underestimated the thermodilution output measurement by 0.54+ 0.37 L/min (95% confidence     interval 0.66-0.94).   "
197019|NCT00427752|"     This study is being conducted to determine whether an endoscope, (a small, flexible tube with     a camera mounted on the end) passed down through the throat, through the stomach, and into     the abdomen can safely and accurately examine the organs and tissue of the abdomen and take     biopsies if needed. We wish to determine if this endoscopic diagnostic route is as efficient     as the laparoscopic diagnostic route, which is currently the standard of care.   "
197020|NCT00427765|"     Primary Objectives:        1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan          at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily          area under the plasma concentration versus time curve (AUC) of approximately 5,000          mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in          adult patients receiving autologous or allogeneic transplantation for lymphoid          malignancies or myeloma.        2. To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this          regimen.        3. To determine the disease-free and overall survival of patients receiving this          preparative regimen.        4. To determine the treatment-related morbidity and mortality of this combination of drugs.   "
197021|NCT00427778|"     This study aims as defining success rate of the incontinence ring in women with test proven     stress urinary incontinence and determining factors associated with successful use.   "
197383|NCT00430092|"     The purpose of this phase III study is to determine the efficacy of difluprednate in the     treatment of inflammation following ocular surgery.   "
197022|NCT00427791|"     Primary Objective:        -  To determine the progression free survival (PFS) of the preparative regimen rituximab,          etoposide and total body irradiation (TBI), in patients with acute lymphoblastic          leukemia (ALL) receiving allogeneic hematopoietic stem cell transplantation (SCT).      Secondary Objectives:        -  To determine the effect of rituximab on the incidence of acute graft vs. host disease          (GVHD).        -  To determine the efficacy of adding imatinib mesylate post transplant in ALL patients          with the t(9;22)(q34;q11) cytogenetic abnormality.        -  To estimate the probability of molecular complete remission at one year for the          described treatment approach as determined by serial minimal residual disease (MRD)          monitoring.        -  To determine the rate of GVHD, engraftment, toxicity, and overall survival (OS) for this          treatment regimen.   "
197023|NCT00427804|"     This study is a pilot study to determine whether patients with TNFα excess have decreased     calcium absorption in response to calcitriol (1,25-dihydroxyvitamin D, the active form of     vitamin D) compared to normal controls. This initial pilot study is being done to determine     if it is feasible to conduct a study where TNFα could be blocked (e.g., by anti-TNFα therapy     such as Enbrel® or Remicade®) to improve vitamin D dependant calcium absorption and thus bone     health.   "
197024|NCT00427817|"     The main objective of this study is to realise serum protein profiles for each patient     undergoing a prostate biopsy and to identify relevant proteins.   "
197025|NCT00427830|"     This is a phase I study to examine the safety and immunogenicity of MVA85A delivered     intradermally into the deltoid region in volunteers who have recieved BCG in the past 20     years.   "
197026|NCT00427843|"     The purpose of this study is to determine the influence of a home program of exercises for     the hip muscles which support the pelvis on walking patterns and hip muscle strength in     people with knee osteoarthritis. Following a hip muscle strengthening program, we hypothesize     that participants with knee osteoarthritis will demonstrate decreased loading at the knee     joint during walking and greater strength of the hip muscles.   "
197027|NCT00427856|"     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow     unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process     of cell death that is often inhibited in cancer cells.   "
197028|NCT00427882|"     Primary:      To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or     premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score.      Secondary:        -  To evaluate sexual function improvement        -  To evaluate LUTS (Lower Uninary Tract Symptoms) improvement        -  To evaluate the association between LUTS severity and sexual function.        -  To assess the safety and the tolerability of Alfuzosin 10mg OD.   "
197528|NCT00433316|"     In our prospective, randomized, placebo controlled and double-blinded study we will study the     efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecological     laparoscopic surgery.   "
197029|NCT00427895|"     This study will assess the safety, tolerability and immune response of 13-valent pneumococcal     conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine     (23vPS). Although the study started with only 1 population, amendments to the original     protocol will now reflect three participant populations. Three age cohorts will be enrolled.     The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49)     are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart.     Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS.     Comparisons of immune responses from the different cohorts will be done.   "
197030|NCT00427908|"     This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the     vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in     children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2     years) as controls. In the long-term follow-up phase of the study, the long-term protection     offered by the vaccines will be assessed up to 5 years after vaccination.      Subjects will be randomized in the primary vaccination phase of the study; no new subjects     will be enrolled during the long-term follow-up phase of the study.   "
197031|NCT00427921|"     To make adalimumab available to subjects suffering from moderately to severely active Crohn's     Disease (CD) and to expand the safety information on adalimumab. The study also assessed     changes in Patient Reported Outcome Measures from baseline.   "
197032|NCT00427934|"     The purpose of this study is to evaluate whether maraviroc, an investigational drug given     with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in     adult patients.   "
197033|NCT00427947|"     Analgesia following leg amputation is based on morphine administration. For elderly patients     of ASA physical status 2 or 3, morphine sparing is possible when perinervous block techniques     are used. Phantom limb pain complicates leg amputation in 50 to 80% of cases. Prevention of     these pains has been studied in various clinical trials but the interest of perinervous block     technique remains to be evaluated.      The purpose of the study is to evaluate the benefit of perioperative locoregional analgesia     by ropivacaine via a popliteal sciatic catheter on intravenous morphine consumption during     the 72 first postoperative hours following leg (below knee) amputation The study will be     randomized, double blinded, controlled clinical trial and 84 patients undergoing leg     amputation (below knee) will be included Patients will be divided into 2 groups: one group of     patients who will benefit perioperative locoregional analgesia by ropivacaine via a popliteal     sciatic catheter and morphine for analgesia and the other one who will benefit placebo     through the catheter and morphine.      The investigators will evaluate the efficacy of the continuous popliteal sciatic nerve block     in postoperative analgesia after leg amputation and prove the efficacy of a perioperative     analgesia by continuous popliteal sciatic nerve block to prevent phantom limb pain after leg     amputation in patients of ASA physical status 2 or 3.   "
197034|NCT00427960|"     The purpose of this study is to compare the effectiveness and safety of rosuvastatin 5mg in     lowering blood cholesterol, compared to one other medicine, atorvastatin 10mg in Asian     patients in the UK.   "
197035|NCT00427973|"     This phase II trial is studying how well AZD2171 works in treating patients with locally     advanced unresectable or metastatic liver cancer. AZD2171 may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth and by blocking blood flow to the     tumor   "
197036|NCT00427986|"     The purpose of the present study is to examine, if retinal swelling in diabetic patients can     be reduced by an intravenous injection of galactose.   "
197039|NCT00428025|"     Inflammation of the pancreas (pancreatitis) is an uncommon but potentially serious     complication of endoscopic retrograde cholangiopancreatography (ERCP), a specialized     endoscopic examination of the ducts draining the liver and pancreas. Although many different     strategies have been tried and studied in attempts to reduce this risk, few have been shown     to make a significant difference. Those that have are either very expensive, difficult to     administer, or both.      Diclofenac, an anti-inflammatory medication most often used to treat arthritis, has shown     potential to decrease the risk of post-ERCP pancreatitis. It can be given after the procedure     to patients at most risk for the complication, and has few side effects. This study will     randomize people in the study to placebo or active medication, to determine if Diclofenac     reduces the incidence of pancreatitis.   "
197040|NCT00428038|"     The purpose of this study is to evaluate how easily gas can be taken up by the lung. We are     comparing infants born premature <32 weeks gestation to infants born full term >37 weeks. We     hope to evaluate the differences between the two groups in order to learn more about     premature lung growth and development.   "
197041|NCT00428051|"     The study will determine the reduction in invasive pneumococcal disease (IPD) after the     introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study     determine incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia.     LEAP II is the continuation of the study in Colombia only.   "
197042|NCT00428064|"     To assess equivalence in the rates of functional graft survival at 12 months after     transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune,     Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and     concentration-controlled sirolimus.   "
197043|NCT00428077|"     RATIONALE: Vaccines made from a peptide may help the body build an effective immune response     to kill cancer cells.      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients     with chronic phase chronic myelogenous leukemia.   "
197052|NCT00428194|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib and     cisplatin may make tumor cells more sensitive to radiation therapy. Giving erlotinib together     with cisplatin and radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when     given together with cisplatin and radiation therapy in treating patients with stage IB, stage     II, stage III, or stage IVA cervical cancer.   "
197551|NCT00433615|"     This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal     anemia patients on Predialysis.   "
197044|NCT00428090|"     Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes     mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the     investigational drug, is an extended-release form of RSG. This study tests whether RSG XR     safely provides benefit to people with mild to moderate Alzheimer's disease (AD). RSG XR is a     new approach to AD therapy and this study tests whether one's genes alter the effectiveness     of RSG XR. Glucose is used by cells to make energy that they need to live. Changes in the     ability of cells to use of glucose can lead to diseases like diabetes. Glucose levels may be     lower in the brains of AD patients, and their brain cells may also use glucose less well than     in unaffected people. The proper function of brain cells may be critical to memory and     thought. If brain cells use glucose poorly, this might impact AD. Drugs that help brain cells     properly use glucose may help a person maintain normal memory and thinking. Data suggesting     that RSG may help AD patients was first seen in a small study at the Univ. of Washington and     then from a larger international GSK study. In the first study, those receiving RSG once     daily for 6 months scored better on 3 tests of memory and thought than those who did not     receive RSG. In the GSK study, those that benefited most from therapy with RSG XR had a     specific genetic pattern. They lacked the gene that caused them to produce apolipoprotein E     e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent,     or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE     e3 version of the gene from one parent. Subjects with one copy of the APOE e4 gene remained     fairly stable while those with two copies of APOE e4 continued to worsen during the 6-month     treatment. This study will directly test the effect of RSG XR on people who either have or     lack the APOE e4 gene.   "
197045|NCT00428103|"     The primary aim of this study is to assess the changes on the shape and function of the left     ventricle in patients with severe mitral valve regurgitation due to congestive heart failure     and cardiomyopathy who undergo mitral valve reconstruction with a Geoform ring.     Three-dimensional echocardiogram will be used for precise evaluation of the shape and     function of the ventricle.   "
197046|NCT00428116|"     Given the high mortality associated with infant HIV-1 and the fact that surrogate markers are     poorly predictive of mortality risk,empiric highly active antiretroviral therapy (HAART)     initiation is started in infants younger than 12 months. A problem with this approach is that     it obligates infants to life-long therapy, which may be associated with cumulative drug     toxicity, poor adherence, and treatment failure. Early HAART for prevention of mortality     during the first 2 years of life has potential to salvage immune function and alter viral     set-point, allowing withdrawal of therapy, perhaps for several years, until subsequent CD4%     decline requires it. This untested approach is attractive because it combines the survival     benefits of early pediatric HAART therapy with the benefits of antiretroviral deferral.      One hundred and fifty infants who initiated HAART at <13 months of age will be treated with     HAART regimen for 24 months after which those who have immune reconstitution and adequate     growth (~100) will be randomized to continued versus deferred therapy. Clinical outcomes,     growth, and toxicity will be compared in these children to determine if interruption is a     safe and beneficial strategy. Follow-up in this studies will be closely monitored by an     external Data Safety and Monitoring Board (DSMB).   "
197047|NCT00428129|"     A single centre, single-arm study to evaluate safety and efficacy of microplasmin     administration via the Trellis-8 Infusion System in patients with acute iliofemoral DVT   "
197048|NCT00428142|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine,     and prednisone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can     block cancer growth in different ways. Some block the ability of cancer cells to grow and     spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. Giving bortezomib together with combination chemotherapy and rituximab may kill more     cancer cells.      PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib     together with combination chemotherapy and rituximab works when given as first-line therapy     in treating patients with stage III or stage IV follicular non-Hodgkin's lymphoma.   "
197093|NCT00428753|"     This study will determine risk factors of human infection with avian influenza A virus, also     known as bird flu virus. Certain risk factors such as exposure to poultry, travel history,     health status, and other factors may affect one's risk of getting bird flu. Study     participants will include individuals, older than age 1, that tested positive for influenza A     (H5N1) in a previous surveillance program and controls (individuals that have not tested     positive for avian influenza A (H5N1) and have no fever or respiratory symptoms). There will     be 1 study visit during which volunteers will be asked detailed questions about their health,     work, and travel habits. Study participants will be asked to donate a blood sample to test     for antibodies, the part of the blood that fights infection.   "
197049|NCT00428155|"     PCI (coronary angioplasty) is a procedure performed through a catheter to open up blockages     in the coronary arteries using balloons and stents for the treatment of angina or myocardial     infarction. The balloon catheters and stents are moved to the coronary arteries through a     “sheath” (a small tube used for placing of balloon and stent catheters in the body) placed in     a major artery passing through the groin. After the PCI procedure and the removal of sheath,     an “arterial closure device” is commonly placed to stop bleeding and allow you to get out of     bed sooner. Although the usefulness of “closure devices” has been documented before their     approval by the regulatory authorities, it is unclear if one device is better compared to     other commercially available devices.      The purpose of the study is to compare the two approved arterial closure devices, “Angioseal”     and “Starclose”. This study will help us identify the better of the two devices to improve     patient comfort after the procedure.   "
197050|NCT00428168|"     This is a randomized, double-blind, placebo-controlled, multicenter, multinational study.     Approximately 78 subjects (39 per treatment group) will be randomized into this 16 week     study.      A screening visit will be used to determine subject suitability for inclusion in the trial.      Within 7 days of the screening visit, subjects who meet all inclusion criteria and none of     the exclusion criteria will be randomly assigned to 1 of the following 2 treatment groups:        -  Olanzapine OD plus betahistine 24 mg BID (48 mg/day total),        -  Olanzapine OD plus matching placebo BID.      Double-blind treatment will continue for 16 weeks. During this period, olanzapine dosage will     be determined according to the discretion of the treating physician. In addition, 5 study     visits (at 2, 4, 8, 12, and 16 weeks) will take place. Study medication (betahistine or     matching placebo) will be administered BID (in the morning and together with olanzapine in     the evening).      The primary statistical hypothesis to be tested is that the mean change from Baseline to Week     16 will be different between the treatment and placebo groups   "
197135|NCT00429312|"     The purpose of this research study is to find out whether JX-594 (Pexa-Vec) is safe and     effective for treating surgically unresectable malignant melanoma.   "
197053|NCT00428207|"     The purpose of this study is to determine:        1. whether there is a difference between insulin aspart and insulin lispro in continuous          insulin pump therapy        2. whether duration of the insulin infusion set placement effect blood sugar control if the          infusion set is in place for longer then 72-96 hours   "
197054|NCT00428220|"     This is a study using sunitinib for patients ending treatment on a previous sunitinib malate     protocol to continue to receive sunitinib. The patient must have been enrolled in one of the     following studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108,     A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer     sponsored sunitinib studies may be included in the future.   "
197055|NCT00428233|"     The purpose of this research study is to collect, freeze and store leukemia cells from the     blood or bone marrow of patients that have advanced chronic lymphocytic leukemia (CLL) that     is not in clinical remission. This study is a companion study to DF/HCC clinical trial 06-196     in which the participants' own CLL cells may form part of a vaccine treatment for their     leukemia.   "
197056|NCT00428246|"     The study is about possible protective effects of paricalcitol (Zemplar) upon inflammation,     blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become     abnormally stimulated and accumulate in the kidney and cause damage to the kidney. The     purpose of this study is to determine if paricalcitol helps improve kidney injury, blood     pressure control and kidney function in patients with chronic kidney disease. The study will     last about 7 weeks and involves about 8 visits to the medical center.   "
197057|NCT00428272|"     Background        -  HGS-ETR2 is a monoclonal antibody, produced in the laboratory from human genes.        -  HGS-ETR2 targets a protein called the TRAIL receptor that is located on the surface of          some tumor cells. When the TRAIL receptor is activated, it can cause the tumor cell to          self-destruct.      Objectives:        -  To determine the highest dose of HGS-ETR2 that can be given safely in children and young          adults with cancer.        -  To study the pharmacology (how the body handles the drug) of HGS-ETR2 by measuring the          amount of drug in the bloodstream over time before and after a dose is given to the          patient.        -  To determine if HGS-ETR2 can stop or slow tumor growth.        -  To determine whether proteins in tumor tissue before treatment can predict whether the          tumor will respond to HGS-ETR2 therapy.      Eligibility:      -Patients 1 to 21 years of age with solid cancers that do not respond to standard therapy.      Design:        -  HGS-ETR2 is given through a vein (intravenously, IV) once every 14 days. Each treatment          cycle is 28 days long and consists of two doses of HGS-ETR2.        -  The dose of HGS-ETR2 is increased in successive small groups of patients until the          maximum tolerated dose (highest dose with acceptable side effects) is determined.        -  During the treatment period, patients have a physical examination at least once a week,          and routine blood tests at least twice a week. These tests are done less frequently in          later treatment cycles.        -  Additional blood samples are drawn for immunology and pharmacology studies.        -  Tests to monitor the size of the tumor (X-rays, CT scans, MRI, PET scans) are done          periodically throughout the treatment period.        -  Patients may continue to receive HGS-ETR2 until unacceptable side effects develop or the          tumor grows.   "
197058|NCT00428285|"     The purpose of this study is to assess if argon plasma coagulation (APC) is a safe and well     tolerated treatment method for anal intraepithelial neoplasia (AIN) grade 2/3 in HIV-positive     men having sex with men (MSM).   "
197094|NCT00428766|"     The purpose of this study is to establish the safest dose of MORAb-003 in subjects with     advanced ovarian cancer. MORAb-003 is an antibody directed to an antigen on the surface of     ovarian cancer cells.   "
197095|NCT00428779|"     The main purpose of the present study is to determine the relative contributions of central     and peripheral fatigue during an ultra-endurance exercise.   "
197096|NCT00428792|"     This study evaluated the safety and clinical effect of treatment with methylphenidate under     different breakfast conditions (minimal breakfast versus standard continental breakfast) in     children with Attention-Deficit Hyperactivity Disorder (ADHD).   "
197059|NCT00428298|"     This is a sixteen week, randomized, double-blind add-on study of valacyclovir versus placebo     in approximately 60 outpatients meeting diagnostic criteria according to the Diagnostic and     Statistical Manual of Mental Disorders (DSM) -IV Bipolar I or II disorder, testing positive     for HSV-1 and who have demonstrable cognitive impairment defined as a total score of less     than 85 (one standard deviation from the normal range) on the Repeatable Battery for the     Assessment of Neuropsychological Status (RBANS). Each patient will be randomized to     double-blind treatment with either valacyclovir or placebo for sixteen weeks. All subjects     will be maintained on a stable regimen of psychiatric drugs prescribed by their treating     psychiatrist. Patients will be evaluated every 2 weeks by the treatment team and mood rating     scales will be administered at each visit including the Young Mania Rating Scale (YMRS) and     the Montgomery Asberg Depression Rating Scale (MADRS). The RBANS will be administered again     at 8 and 16 weeks. Both the treatment team and the patient will remain blinded during the     course of the study. Following the active treatment phase, patients will receive treatment as     clinically indicated.      Primary Hypothesis:      Valacyclovir will be superior to placebo in reducing cognitive symptoms associated with     bipolar disorder in subjects who have been previously infected with Herpes Simplex virus I     (HSV-1).      Secondary Hypothesis:      Valacyclovir will be superior to placebo in reducing mood symptoms associated with bipolar     disorder in subjects who have been previously infected with HSV-1.   "
197060|NCT00428311|"     Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting     with the polycystic ovary syndrome - in association with insulin resistance, obesity, and     other metabolic disorders.      The present clinical trial intends to compare the effects of oral contraceptives and     metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers     and indexes of cardiovascular performance, in order to whether or not, as suspected by     previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the     cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter     actually ameliorates such a risk.   "
197061|NCT00428337|"     The purpose of this study is to determine the safety of and immune response to two     experimental vaccines, designed for use in combination, for the prevention of HIV infection     in healthy adults.   "
197062|NCT00428350|"     The primary objective of the study is to evaluate the efficacy of quetiapine fumarate     (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute     schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day     56 using the last observation carried forward (LOCF) method.   "
197156|NCT00429585|"     This study looks at two types of surgical treatments and hopes to answer the question: which     is the best way to surgically treat a proximal tibia fracture? Both procedures being studied     are standard of care (used routinely) and use FDA approved devices. All medical and surgical     treatment will be the same for participants as non-participants.   "
197063|NCT00428363|"     Purpose: To compare the posterior capsule opacification (PCO) inhibiting effect of the sharp     posterior optic edge design of the Clariflex silicone intraocular lens (IOL) with that of the     double-round edge design of the SI40 (Phacoflex) silicone IOL over a period of 3 years.      Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.      Methods: Fifty-two patients with bilateral age-related cataract (104 eyes) were included in     this randomized, prospective, bilateral, patient- and examiner-masked clinical trial with     intra-individual comparison. Each study patient had cataract surgery in both eyes and     received an SI40 IOL (anterior and posterior round optic edges) in one eye and a Clariflex     IOL with OptiEdge (round anterior and sharp posterior optic edge) in the other eye. Follow-up     examinations were at one week, one month, six months, one, two, and three years. Digital     retroillumination images were taken of each eye. The amount of PCO was assessed subjectively     at the slit-lamp and objectively using automated image analysis software (AQUA) one, two, and     three years after surgery.   "
197064|NCT00428376|"     This is a randomized controlled trial of distributing blocks to children ages 1.5 -2.5 years     of age to see if language acquisition improves.   "
197065|NCT00428389|"     This study was designed to evaluate the safety and tolerability of switching from donepezil     to an initial dose of 5cm^2 rivastigmine patch formulation in patients with probable     Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period     followed by a 20-week open-label extension period. Patients were randomized to either an     immediate switch from donepezil to rivastigmine patch formulation or to a switch to     rivastigmine patch formulation following a 7-day withdrawal period.   "
197066|NCT00428402|"     The MIDAS Project (Models of Implementation and Dissemination of Environmental Health and     Science Across Subjects) Assessment Objectives:        -  Determine whether students are aware of the MIDAS Project.        -  Identify strengths and weaknesses of MIDAS Project components including: integrated          environmental health and science (EHS) curricula, field experiences, seminars and          student projects.        -  Assess career interests and intended courses of study at the college level.   "
197067|NCT00428415|"     Purpose:      To evaluate the effect of tesofensine on energy balance   "
197068|NCT00428428|"     The purpose of the study is to examine the effect of endoluminally administrated     isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We     propose that isoproterenol has potential of reducing intrarenal pressure during     ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the     procedure and reducing intraoperative complications as bleeding and infections.   "
197069|NCT00428441|"     Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous     thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate     evidence. More than 12 months of treatment are currently recommended, and the grade of     recommendation is low.      The PROLONG study has recently evaluated the predictive role of D-dimer measurement after     withholding oral anticoagulant treatment in patients with a first episode of VTE. Patients     with a positive D-dimer had a significantly higher incidence of VTE recurrences than patients     with a negative D-dimer and required resumption of the antithrombotic treatment. Based on the     results of this and of previous cohort studies, it appears safe to withhold treatment in     patients with negative D-dimer values and to continue treatment in patients with altered     D-dimer levels.      Aim of this study is therefore to assess the negative predictive value of D-dimer also in     patients with recurrent VTE and to evaluate the clinical utility of this approach in this     patient setting.   "
197104|NCT00428896|"     Based on preclinical data, ZD1839 is considered a novel and promising therapeutic approach     with potential application in the treatment of human breast cancer. Therefore it could be     very important and clinically relevant to know if ZD1839 is capable of eliminating occult     tumour cells circulating in the blood of breast cancer patients   "
197070|NCT00428454|"     Primary intracoronary stent placement after successfully crossing chronic total coronary     occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with     conventional balloon angioplasty. Several studies have shown the efficacy of     sirolimus-eluting stents in selected groups of patients. In the PRISON II study we     demonstrated that sirolimus-eluting stents were superior to bare metal stents in CTO. In this     prospective randomized trial, sirolimus-stent implantation will be compared with     zotarolimus-eluting stent implantation for the treatment of chronic total coronary     occlusions. A total of 300 patients will be clinically followed up for 1, 6, 12 months, 2, 3,     4, 5 year with angiographic follow-up at 8 months. Quantitative coronary analysis will be     performed by an independent core laboratory. The primary end point is in-segment late luminal     loss at 8 month angiographic follow-up.   "
197071|NCT00428467|"     The current study analyses the LV geometry of failing LVs measured by MRI scanning with     respect to systolic versus diastolic function. A new surgical method for remodelling enlarged     left ventricles is introduced.An apical remodelling stitch led to significant remodelling     which was accompanied by improvement in ventricular function.   "
197072|NCT00428480|"     The primary purpose of this study is to determine the effects of reinforcement of walking     speed on recovery of walking speed over the course of inpatient rehabilitation for people     after stroke. The study will also examine the relationship between short distance walking     speed and walking distance over a fixed time.   "
197073|NCT00428493|"     The purpose of this study is to see if people in China who have contact with someone infected     with bird flu (H5N1) become infected themselves without necessarily getting sick. Adults and     children greater than 1 year of age who have contact with someone infected with bird flu may     participate in the study. At the first 1-2 study visits, a blood sample will be taken from     volunteers in order to test for antibodies, the part of the blood that fights infection. If     the result of the H5N1 antibody test is positive after the 1st or 2nd study visit, an     additional blood sample will be collected during a 3rd and 4th study visit. Volunteers will     be asked questions about their work, home life, and possible contact with poultry, other     birds, animals, and people infected with bird flu. Participants will be involved in study     related procedures for up to 90 days.   "
197074|NCT00428506|"     The purpose of this study is to determine whether the infusion of albumin 4 gr per liter of     ascites removed is as effective as the infusion of albumin 8 gr per liter of ascites removed     in the prevention of post-paracentesis circulatory dysfunction   "
197075|NCT00428519|"     The investigators' in vitro data suggest that Neurokinin-1 receptor antagonists like     aprepitant will decrease the expression of CCR5, an essential co-receptor in the life cycle     of HIV, in the surface of macrophages and lymphocytes to levels at least similar to those     observed in patients heterozygous for the CCR5 32 mutation. Together with a direct potential     antiviral effect this could alter disease progression in patients with HIV infection.      The investigators' hypothesis is that aprepitant is safe, tolerable and has antiviral     activity in HIV infected individuals.      This is randomized, placebo controlled, double blind study to determine the safety and     antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks     of aprepitant monotherapy.      27 HIV infected males and females ≥ 18 years old who have early infection with CD4 cell     counts ≥ 350 cells/mm3. Subjects will be randomized 1:1:1 to receive two different doses of     aprepitant (Emend®) or placebo.   "
197076|NCT00428532|"     The study will check whether taking 100 mg of licorice root extract or 250 cc of pomegranate     juice daily by men with diabetes mellitus who are non-smokers and already treated with     statins decreases the risk of developing atherosclerosis. The hypothesis of the study is that     natural anti-oxidants (such as licorice root extract and pomegranate juice), by scavenging     free radicals, retard and may even reverse atherosclerosis.   "
197077|NCT00428545|"     The goal of this clinical research study is to find the highest tolerable dose of Avastin™     (bevacizumab) and Velcade™ (bortezomib) that can be given in combination to patients with a     metastatic or unresectable advanced malignancy. The safety and effectiveness of this drug     combination will also be studied.   "
197078|NCT00428558|"     Core binding factor (CBF) acute myeloid leukemias (AML) include AMLs carrying the t(8;21)     translocation as well as AMLs carrying either the inversion of chromosome 16 or translocation     t(16;16). CBF-AMLs are characterized by their high sensitivity to standard chemotherapeutical     agents, especially to cytarabine when administered as high-dose bolus infusions, and thus by     a relative good prognosis. However, relapse rates are still comprised between 30 and 50% in     these patients, even if overall survival may reach approximately 65% due to the potential     salvage of late relapses.      The primary purpose of the protocol is to compare two modalities of timed-sequential     induction in order to improve the results of the treatment of CBF-AML patients. This protocol     also includes the biological characterization of the heterogeneity of these diseases (gene     mutation and transcription profiles), as well as a centralized minimal residual disease     monitoring and centralized evaluation of pharmacogenetic polymorphisms.   "
197079|NCT00428571|"     A large number of research studies on people who were morbidly obese (extremely overweight),     and had bariatric surgery (anti-obesity surgery) have shown that patients who were diabetic     before surgery often experienced significant improvement in their diabetes following the     surgery. For some patients, blood glucose levels returned to the normal range, and they were     able to stop taking all of their diabetes medications. For others, blood glucose levels     improved, allowing them to reduce their diabetes medications.      This research study is being done to determine whether bariatric surgery can safely provide     better control of diabetes symptoms in obese diabetics than continuing medical management     (anti-diabetic drugs in combination with diet and lifestyle changes).      There are several different types of bariatric surgery currently being used to treat morbid     obesity. Two of the most common techniques are gastric bypass and adjustable gastric banding.     This study will be comparing these two surgical techniques to treatment with a combination of     drugs, diet, and lifestyle changes for control of type 2 diabetes.   "
197080|NCT00428584|"     To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with     relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site     pain scores from pre-injection to 30 minutes post therapy administration.   "
197081|NCT00428597|"     This study randomized patients with advanced pancreatic islet cell tumors to receive either     sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib     daily, those randomized to placebo received a tablet that looked similar but had no active     drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or     placebo. Patients were followed to determine the status and size of their tumors, survival,     quality of life and safety of the drug.      The study was designed to detect a 50% improvement in median PFS[Progression Free Survival]     with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130     events had occurred, and the final analysis was to be conducted when 260 events had occurred.      Study A6181111 was stopped early during the enrollment period because of a clear and     clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended     by the DMC [Data Monitoring Committee]. The actual number of subjects enrolled was 171 and     the actual number of PFS events recorded was 81 PFS events. The decision to terminate the     study was not based on safety concerns related to sunitinib administration.   "
197082|NCT00428610|"     The primary objective is to determine whether LY573636 is effective in treating     platinum-resistant ovarian cancer. Patients will receive an intravenous infusion of study     drug once every 28 days. CT scans and CA-125 tests will be done before the first dose and     then after every other treatment.   "
197083|NCT00428623|"     The study is a prospective randomised, controlled study of 136 patients undergoing vascular     surgery. Their closed wounds were covered with either aquacel, a hydrofiber dressing, or a     traditional gauze dressing.Number of changes, patient comfort,number of infections, length of     hospital stay and wound complications were compared between the two groups.   "
197084|NCT00428636|"     We conducted a prospective randomized study to evaluate the results of early closure of     temporary loop ileostomy at eight days in comparison with late closure at two months, after     elective rectal resection with low pelvic anastomoses.   "
197085|NCT00428649|"     The purpose of this study is to determine the amount of selenium as selenomethionine that is     required to optimize selenoprotein P in selenium-deficient Chinese subjects   "
197157|NCT00429611|"     This inhospital study aims to compare the efficacy of high-versus low-energy biphasic shocks     in order to determine the optimal level for defibrillation. Time is the essence when     attending to a VF patient. Hence, it is important to determine the optimal amount of     defibrillation energy that should be delivered at first shock, thereby increasing the     patient's chances of survival. In addition, this study provides an opportunity to evaluate     the impact on myocardial integrity/function of different levels of defibrillation energy in     an inhospital clinical environment.   "
197086|NCT00428662|"     Coronary artery disease (CAD) is the largest cause of death and disability in the world.     Besides medicines, the principle treatment of this condition requires opening of the narrowed     arteries, responsible for angina and other symptoms of the disease, by angioplasty or     surgery. Introduction of metal scaffolds called 'stents' in the past few decades     revolutionised the angioplasty technique, and has made it the most popular treatment today     for CAD. However these stents are prone to becomin narrow and obstructed after implanataion,     causing symptoms and non-fatal heart attacks in some patients. Introduction of stents that     slowly release drugs locally to minimize this process, called 'drug-eluting stents'(DES)he     past few years has been one of the biggest breakthroughs in the field of cardiology. However     ven the current available DES are still prone to narrowing in high-risk patients, like those     with diabetes, and also have a higher chance for sudden blockage by a blood clot even many     years later after insertion. Thus it is important to develop technology for more efficacious     and safer DES.This includes safer drugs, better stent design and delivery, and more inert     platforms for drug release We hypothesise that a new stent made with nanoporous particle with     better polymer for drug release will prove to be safer and more efficacious alternative to     currently available DES.   "
197087|NCT00428675|"     Fatigue is a common problem in advanced cancer and palliative care. The development of tools     to measure fatigue, however, has been slowed by their inability to distinguish between     fatigue and other related symptoms, such as tiredness. Our work suggests that these     distinctions are important because they serve as markers for stressors associated with     advancing disease. We have developed a tool that we believe will distinguish between these     two states as well as exhaustion. In this study we will conduct some initial tests of this     tool in preparation for its use as an outcome indicator in future studies.   "
197088|NCT00428688|"     The aim of the proposed study is to assess endothelial function and IMT, as correlates of     cardiovascular disease (CVD), in young adult Hodgkin's disease (HD) survivors, and to relate     endothelial function to other risk factors including obesity, dyslipidemia, hyperinsulinemia     and fasting glucose.   "
197089|NCT00428701|"     This study is being done to see if Nexium I.V. can reduce and control stomach acid in     mechanically ventilated, critically ill patients in an Intensive Care Unit setting.   "
197090|NCT00428714|"     The purpose is to see how quickly two different types of prostate cancer patients respond     when taking enzastaurin.      Cohort 1 - asymptomatic patients with androgen-independent PSA-progressive disease with or     without clinical or radiographic evidence of metastatic disease.      Cohort 2 - patients with androgen-independent metastatic prostate cancer (documented bone or     soft tissue metastases) with rising PSA, clinical, radiographic disease progression following     one prior docetaxel-based regimen   "
197091|NCT00428727|"     Diabetes Mellitus constitutes one of the most important public health problems due to its     high prevalence and enormous social and economic consequences. Diabetic foot ulcers are one     of the chronic complications of diabetes mellitus and constitute the most important cause of     non-traumatic amputation of inferior limbs. It is estimated that 15% of diabetic population     will develop an ulcer sometime in their life. Although novel therapies have been proposed,     there is no effective treatment for this pathology. Naturally produced nitric oxide     participates in the wound healing process by stimulating the synthesis of collagen,     triggering the release of chemotactic cytokines, increasing blood vessels permeability,     promoting angiogenic activity, stimulating the release of epidermal growth factors, and by     interfering with the bacterial mitochondrial respiratory chain. Topically administered nitric     oxide has demonstrated to be effective and safe for the treatment of chronic ulcers secondary     to cutaneous leishmaniasis. However, due to their unstable nitric oxide release, the topical     donors needed to be applied frequently, diminishing the adherence to the treatment. This     difficulty has led to the development of a multilayer polymeric transdermal patch produced by     electrospinning technique that guarantees a constant nitric oxide release. The main objective     of this study is to evaluate the effectiveness and safety of this novel nitric oxide     releasing wound dressing for the treatment of diabetic foot ulcers.      A double-blind, placebo-controlled clinical trial, including 100 diabetic patients was     designed. At the time of enrollment, a complete medical evaluation and laboratory tests will     be performed, and those patients who meet the inclusion criteria randomly assigned to one of     two groups. During 90 days group 1 will receive active patches and group 2 placebo patches.     The patients will be seen by the research group at least every two weeks until the healing of     the ulcer or the end of the treatment. During each visit the healing process of the ulcer,     the patient's health status and the presence of adverse events will be assessed. Should the     effectiveness of the patches be demonstrated an alternative treatment would then be available     to patients.   "
197105|NCT00428909|"     A non-randomized, open-label study to investigate the effects of imatinib mesylate on the     pharmacokinetics of acetaminophen/paracetamol in patients with newly diagnosed, previously     untreated chronic myeloid leukemia in chronic phase (CML-CP)   "
197097|NCT00428805|"     Child Health Initiative for Lifelong Eating and Exercise (CHILE) is a trans-community     multidisciplinary site-specific intervention and evaluation plan for a Head Start and     family-based culturally and developmentally appropriate intervention. The primary goals are     to increase physical activity and improve dietary intake through increased consumption of     fruits, vegetables and whole grain and decrease consumption of sweetened drinks and high-fat     foods,decrease television and other screen time, and decrease obesity in three to five year     old Hispanic and American Indian children enrolled in Head Start programs in rural New     Mexico. The trans-community intervention includes: A classroom curriculum for children; an     in-service training program for Head Start teachers and educational aides; a school food     service component; a family intervention; a community leader/local health care provider     component; and a grocery store component.      Participants include 16 Head Start programs serving Hispanic and Native American children and     families from underserved communities in rural New Mexico. This is a randomized trial with an     Intervention Condition and Control Condition. One cohort of three-year old Head Start     students will be followed and measured for two years. During the two years in Head Start     those children, their teachers, and families enrolled in the Intervention Condition will     receive a program of activities to modify their dietary, physical activity, and screen     viewing behaviors. Also addressed are the Head Start and community environments and policies,     local grocery stores, and health care providers.      CHILE uses an ecological framework including social cognitive theory, intervention mapping,     environmental and policy changes, developmental theory, and sound educational practices. The     approach includes in from the community to ensure acceptability, cultural appropriateness,     feasibility, sustainability, and later transferability to similar communities.      The primary outcome measures include changes in physical activity levels, dietary fiber     intake, dietary fat intake, intake of sugared drinks, television viewing and other screen     time, in BMI. Secondary measures include changes in the Head Start and community environments     and policies related to physical activity, school food service, school snacks, and     availability of healthful options. We will also examine the role of community leaders,     especially health care providers, in raising awareness and creating a supportive and     sustainable environment for the prevention of obesity.   "
197098|NCT00428818|"     Background: In many communities, skin and soft tissue infections (SSTI) with MRSA have become     more prevalent than infections with β-lactam susceptible bacteria. This has necessitated     altered empiric antimicrobial therapy of SSTI to cover MRSA.      Objective: To evaluate empiric therapy with trimethoprim-sulfamethoxazole or doxycycline for     outpatient SSTI in an area of high MRSA prevalence.      Design: Randomized, prospective, open-label investigation. Setting: Emergency Department of     Parkland Hospital in Dallas, Texas. Patients: Adults with SSTI. Intervention: Empiric oral     therapy with trimethoprim-sulfamethoxazole (160 mg/800 mg, twice daily) or doxycycline (100     mg, twice daily).      Measurement: The primary endpoint was clinical failure defined as hospitalization or change     in antibiotic therapy over the 10 to 14 days after initial emergency department evaluation.   "
197099|NCT00428831|"     The main purpose of this study is to look at relationships between types of flu viruses and     characteristics of infected patients, including vaccination status, organ system involvement,     and disease severity. In this study, 500 patients with respiratory illnesses will have     nose/throat fluid samples collected. At Children's Hospital Boston, patients 30 days to 5     years of age will be recruited; at Beth Israel Deaconess Medical Center, patients of any age     will be eligible. The researchers will compare the symptoms of infection by similar flu virus     types and look at differences in the flu virus types between the 2 age groups of patients.     The researchers will also look at whether any flu virus types first show up in the children     prior to infecting the adults. Hopefully this study will improve understanding of how flu     viruses develop, spread, and cause disease. This information may help the development of more     effective flu vaccines, prevention measures, and treatments.   "
197100|NCT00428844|"     This is a research study designed to look at the efficacy and safety of daptomycin given at a     dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections     caused by Staphylococci. These types of bacteria are among the most common types of bacteria     causing infections of prosthetic joints.   "
197101|NCT00428857|"     Rationale: respiratory complications are the most frequent complications following lung     resection and represent a noticeable cause of mortality. Benefits from non-invasive     ventilation (NIV) in acute respiratory failure are now clearly demonstrated. The use of     preventive NIV after lung resection, in the absence of acute respiratory failure and/or     hypercarbia, could be justified by the physiological benefits expected. The goal of this     study is to assess the efficacy of post-operative NIV in moderate-to-severe COPD, for     prevention of respiratory complications.      Material and Methods: This is a prospective randomised multicenter trial with an open     parallel design in moderate-t-o-severe COPD patients hospitalised in thoracic surgery for     lung resection.      Expected results: This study will determine whether post-operative NIV decreases the     incidence of acute respiratory events (acute respiratory failure) and whether some subgroups     of patients benefit more from this strategy.      Conclusion: This study should help evaluating the utility of post-operative NIV after lung     resection.   "
197102|NCT00428870|"     Shoulder impingement syndrome is common and number of operations done per year is growing.     The aim of this study is to compare the value of arthroscopic subacromial decompression     (acromioplasty group) vs. diagnostic arthroscopy (control group) vs. supervised exercise     therapy (conservative group) on subjects with chronic subacromial impingement syndrome. The     results of treatment are measured at 3 months, 6 months, 12 months and 24 months. Main     outcome measures are Pain at rest and activity (VASs), functional assessment of the shoulder     with Constant score and Simple Shoulder test (SST), global assessment of change , quality of     life assessment (SF-36 and 15D) and costs.   "
197103|NCT00428883|"     -  Systemic sclerosis (scleroderma; SSc) is a rare, disfiguring systemic disorder          characterized by fibrosis of the skin and visceral organs that alters every aspect of an          individual life        -  Although some features of scleroderma phenotype are well established and represent the          hallmarks of the disease, the primary cause is not fully delineated, though both          endothelial cell damage, immunological abnormalities and excessive extracellular matrix          production are well-documented        -  Recently, excessive oxidative stress has been implicated in the pathogenesis of          scleroderma        -  N-acetylcysteine (NAC) exhibits direct and indirect antioxidant properties. Its free          thiol group is capable of interacting with the electrophilic groups of ROS. This          interaction with ROS leads to intermediate formation of NAC thiol, with NAC disulphide          as a major end product. The net result is a decrease of the concentrations of OH-, H2O2,          and HOCl. In addition, NAC exerts an indirect antioxidant effect related to its role as          a glutathione (GSH) precursor. It serves as a central factor in protecting against          internal toxic agents.        -  In view of these considerations we expect that NAC can confer substantial benefit in          patients with scleroderma reducing skin fibrosis in view of its antioxidant properties,          and we have decided to conduct a double blind, multicenter trial to establish whether          NAC could ameliorate skin fibrosis in scleroderma patients   "
197106|NCT00428922|"     The primary objectives are to determine the progression-free survival (PFS) and to evaluate     safety of the trastuzumab, bevacizumab and docetaxel regimen.   "
197109|NCT00428961|"     Previous scientific research has found multiple genes that affect the risk for developing     heart disease or complications during the treatment of heart disease. Less is currently known     about how patients with heart disease may differ on the basis of other ailments they may have     and how these other ailments may affect their treatment and prognosis. For this reason,     researchers at the Mid America Heart Institute are conducting this research to find out how     genes affect heart disease and recovery following angioplasty. The study will include     patients with diabetes in order to determine if their genes are different from patients     without diabetes.      A total of 1,607 patients were enrolled. There were 2 groups of patients selected for this     study. The first group of patients included into the study will be those that are scheduled     to have a diagnostic angiogram only. The second group of patients were those that had along     with the angiogram a percutaneous transluminal coronary angioplasty, PTCA and or the use of a     device called a coronary stent, designed to help prop open the artery and to help avoid     collapse. Samples for both groups will be stored for 30 years. After this time, all samples     will be destroyed. Ultimately, we are hopeful that we will identify genes that will identify     groups of patients at risk for heart disease.   "
197110|NCT00428974|"     This study will test the hypothesis that CF101, which is under development to treat other     immune-mediated inflammatory diseases, will provide clinical benefits in the treatment of     chronic plaque psoriasis. Patients with psoriasis who qualify for the study will be treated     every 12 hours (q12h) with CF101 capsules, or placebo capsules, for 12 weeks. The safety of     treatment will be carefully assessed through clinical and laboratory monitoring. The effect     of treatment on psoriasis will be evaluated through standard techniques of examination and     measurement of the severity of skin involvement.   "
197158|NCT00429624|"     The purpose of this study is to determine whether chiropractic manipulation or medical     therapy is effective in the treatment of chronic neck pain.   "
197627|NCT00416156|"     To investigate whether weight reduction by life style modification for 12 weeks will improve     circulating inflammatory markers, adipocytokines as well as gene expression of     proinflammatory protein obtained from circulating monocytes from obese individuals.   "
197111|NCT00428987|"     This study will describe the phenotype (physical and behavioral traits) of overweight and     obese people. It will characterize the hormones, metabolism, food preferences, fitness and     physical activity levels, sleep patterns and thought processes in people with and without     weight problems. Genetic material will be collected for studies of the internal codes that     influence body weight.      People over 18 years of age from all weight categories (lean, overweight, obese) who are     reasonably healthy may be eligible for this study. Participants undergo the following tests     and procedures:        -  Physical exam, electrocardiogram, blood and urine tests, instructions for recording food          intake for 7 days        -  Metabolic studies for menstruating women.        -  Resting metabolic rate to study how many calories the body burns at rest.        -  Mixed meal test to measure hormones such as insulin that regulate blood sugar.        -  Glucose tolerance test to determine how sensitive the body is to insulin.        -  24-hour energy expenditure to measure the amount of oxygen breathed in and the amount of          carbon dioxide breathed out.        -  Repeat 24-hour energy expenditure.        -  Diurnal blood sampling and temperature assessment to study the body s internal clock.        -  Air-displacement plethysmography (Bod Pod) to measure body composition.        -  Dual energy x-ray absortiometry (DEXA) to measure body fat and bone density.        -  Repeat Bod Pod and DEXA.        -  Anthropometric measurements and bioelectrical impedance to measure height, weight, and          circumferences, skinfold thickness, fluid status and percentage body fat.        -  Bromide dilution to measure the amount of water not in cells in the body.        -  Doubly labeled water to measure the amount of calories burned in a 7-day period.        -  24-hour diet reports.        -  Endothelial reactivity to measure how the blood vessels stretch or dilate for assessing          cardiovascular health.        -  Treadmill or bicycle exercise capacity test.        -  Physical activity monitor.        -  Unicorder to detect any breathing difficulties that may interfere with sleep.        -  Fat and muscle biopsy to look for variations in gene expression in fat tissue and          muscle.        -  Neurocognitive testing to check memory, decision-making, hand-eye coordination, and          reasoning.        -  Evaluation of mood problems and assess personality type.        -  Evaluation to assess the quantity and quality of pain experienced.        -  Taste testing to determine the response to bitter, salty, sweet and sour substances.        -  Occupational therapy evaluation to explore the subject s adaptations, if any, for          performing personal, social or professional activities; the subject s views on his or          her weight, body size and shape, and strategies to control weight.   "
197112|NCT00429000|"     Low body temperature (hypothermia (HT)) at birth contributes to infant mortality in     low-income countries. A study from Guinéa-Bissau indicates that HT results in an increased     mortality rate, which persist at least two months after birth. Therefore interventions that     reduce the prevalence of HT might have a significant effect on infant mortality. The purpose     of the proposed study is to identify risk factors for HT in an in-hospital setting in     Guinea-Bissau and to investigate whether continuous temperature-monitoring enabling early     detection of HT and treatment can prevent HT <34,5°C.   "
197113|NCT00429013|"     Will the use of sensory substitution by lingual electric stimulation improve in a suitable     way, for paraplegic subject, the spatial distribution of pressure applied at the seat/skin     interface in order to prevent the formation of pressure ulcer? We will try to demonstrate     that paraplegic subject move in an appropriate matter, in term of pressure, after a movement     way advised by periodical electric stimuli on the tongue.   "
197114|NCT00429026|"     Primary Objectives:        1. To compare the overall survival of metastatic renal cell carcinoma (RCC) patients          undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell          transplantation (NST) using fludarabine-melphalan (FM) versus          fludarabine-cyclophosphamide (FC) conditioning regimen.        2. To assess both cytotoxic T lymphocyte reactivity and antibodies activity against          potential tumor antigenic peptides involved in graft-versus-RCC effect.      Secondary Objectives:        1. To study the patient characteristics of metastatic RCC patients who undergo NST and          those who do not undergo NST.        2. To compare the incidence of Day-100 treatment-related mortality in FM group and FC          group.   "
197115|NCT00429039|"     The purpose of this study is to determine if pre-treating donor lymphocytes with an     investigational drug known as L-leucyl-L-leucine methyl ester (LLME, prior to donor     lymphocyte infusion (DLI) will improve the recovery of the immune system following stem cell     transplant.   "
197116|NCT00429052|"     The main objectives of this study are define frequency of plaque shift phenomenon and impact     on flow dynamics in the side branch as assessed by intravascular ultrasound, and evaluate     acute and late side branch ostial vessel reaction to balloon angioplasty and drug-eluting     stents.   "
197117|NCT00429065|"     The purpose of this study is to determine whether a specific subtype of lymphoma responds     optimally to treatment with rituximab and chemotherapy.   "
197118|NCT00429078|"     This study proposes to determine the safety and tolerability of 2nd generation designer T     cells in patients with gastric cancer.Designer T cells are prepared by removing white blood     cells from the participant, and then modifying these cells so that they recognize tumor     antigen(CEA). These modified cells are then re infused back into the participant so that they     can attack and kill tumor cells.Eligibility for this study is diagnosis of carcinoma of the     stomach with failure to respond to standard curative therapy. Tumors must express CEA as     demonstrated by elevated serum CEA >10ng/ml and be measurable radiologically or by physical     exam.   "
197119|NCT00429091|"     A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with     Attention-Deficit/Hyperactivity Disorder (ADHD)   "
197121|NCT00429117|"     Primary Objective:      -To assess correlations between spiritual and religious beliefs and physician burnout using     the Work Related Stress Inventory.      Secondary Objectives:        -  To assess relationships between a physician's spiritual/religious beliefs and age, race,          sex, marital status, and nationality.        -  To explore differences in survey responses among oncologists from different countries:          Duke University Religion Index (DUREL), Hoge (Intrinsic religiosity scale), Templer's          Death Anxiety Scale, Locus of Control Scale, Work Related Strain Inventory, and          non-validated case scenarios.        -  To correlate survey responses to management of specific patient case situations.   "
197122|NCT00429143|"     The purpose of this study is to develop a way of treating patients who do not have a     completely matched family donor or a readily available unrelated donor with bone marrow     transplant by using a partially-matched family donor. Patients receiving this type of     transplant will receive chemotherapy and/or radiation to treat their disease. They will also     receive their donor's cells in 2 parts. During the first part, the donor's lymphocytes will     be exposed to one of the chemotherapy agents to help the patient become tolerant to the     lymphocytes. In the second part of the transplant, the patient will receive their donor's     stem cells to help recover their peripheral blood counts and establish long-term engraftment.     The hypothesis of this study is that in partially-matched allogeneic transplant, there is a     defined number of donor T-cells that can be treated and given to the recipient to avoid     post-transplant infection without causing severe graft-versus-host disease.   "
197721|NCT00435500|"     The purpose of this study is to determine whether semi-annual fluoride varnish applications     combined with caregiver counseling are effective in preventing and reducing a severe form of     dental decay, known as early childhood caries, in native and non-native children aged 6     months to 5 years.   "
197123|NCT00429156|"     The investigators hypothesize that continuation of non-invasive ventilation (NIV) at home     after an episode of acute hypercapnic respiratory failure (AHRF) treated by NIV in COPD     patients would reduce the likelihood of death and recurrent AHRF requiring NIV or intubation.     The investigators designed this study in a way that recruited COPD patients would be started     on home NIV or sham treatment after an episode of AHRF requiring acute NIV. The patients are     acclimatised to NIV application after a few days of acute use. The investigators chose     occurrence of life-threatening event (recurrent AHRF and death) as the primary endpoint.   "
197124|NCT00429169|"     The primary study comparing effectiveness for suicidal ideation and/or behavior of two     antidepressant medications in depressed patients who have attempted suicide or are currently     experiencing suicidal thoughts has been completed.      A secondary study component using functional magnetic resonance imaging (fMRI) to investigate     different medication effects on reward processing in the same sample is ongoing.   "
197125|NCT00429182|"     The goal of this clinical research study is to learn the relationship of high-dose     chemotherapy (HDCT) and circulating tumor cells (CTCs) in controlling metastatic breast     cancer. The study also will investigate the role of CTCs in breast cancer.   "
197126|NCT00429195|"     The LIPGENE Human Dietary Intervention Study, multi-centre, trans -European, single-blinded,     randomised, controlled trial with two principal aims. Firstly to determine the relative     efficacy of reducing dietary SFA consumption, by altering quality of dietary fat and reducing     the quantity of dietary fat, on metabolic and molecular risk factors of the metabolic     syndrome. Secondly to determine if common genetic polymorphisms affect an individual's     responsiveness to dietary therapy.   "
197127|NCT00429208|"     This research project addresses the hypothesis that a neurocognitive profile characterized by     impairment of response inhibition and sustained attention may be a risk factor for smoking     initiation and nicotine dependence among young women. Nicotine has short- term, facilitating     effects on attention and response inhibition. Therefore, individuals who are impaired on     cognitive functions such as these and initiate cigarette smoking may be more likely to     maintain the habit and develop nicotine dependence. The research protocol specifically tests     whether administration of nicotine to non-abstinent, regular cigarette smokers improves     cognitive function in those domains where the participants had previously been shown to     manifest performance deficits   "
197128|NCT00429221|"     This three-phase study will develop and test a provider-administered intervention to improve     medication adherence and promote sustained medication use among children with ADHD and their     caregivers.   "
197129|NCT00429234|"     The goal of this clinical research study is to find the highest tolerable dose of dasatinib     in combination with gemcitabine that can be given to patients with advanced solid tumors. The     safety of this combination of study drugs will also be studied.      Researchers also want to study the pharmacodynamics (PDs) of this study drug combination. PD     testing is used to learn what effect the drugs have on your tumors.   "
197130|NCT00429247|"     Epithelial tumor cells can be detected in the bone marrow and/or the peripheral blood     [disseminated and circulating tumor cells, (DTCs) and (CTCs) respectively] of otherwise     metastases-free patients with early breast cancer. Several studies have shown that the     presence of these cells is an independent factor associated with an increased incidence of     early disease relapse and disease-related death. In almost 50% of the patients, adjuvant     chemotherapy cannot eliminate these occult tumor cells and this is also associated with a     higher probability of early relapse and death. In 60-70% of the patients, DTCs and/or CTCs     express the HER2/c-neu molecule and one or two administrations of their monoclonal antibody     trastuzumab (HERCEPTIN) could eliminate these cells for a period ranging from 3-12 months.   "
197131|NCT00429260|"     The primary objective is to evaluate the safety and tolerability of abrupt discontinuation of     saredutant over 1 week in outpatients with depression who completed 8 weeks of treatment with     saredutant 100 mg once daily.      The secondary objective is to evaluate the safety and tolerability of 8 weeks of open-label     treatment with saredutant 100 mg once daily in outpatients with depression.   "
197132|NCT00429273|"     This study will evaluate the effectiveness of a single drug versus a combination of drugs in     treating attention deficit hyperactivity disorder in children.   "
197149|NCT00429494|"     Primary Objectives:        -  To determine the effectiveness of the 3-month depot leuprolide in inducing and          maintaining secondary amenorrhea in patients undergo hematopoietic stem cell          transplantation.        -  To determine the incidence of regained ovarian function manifested as spontaneous          restoration of menstruation and normalization of hormonal level in patients after          transplantation and discontinuation of long-acting leuprolide.   "
197384|NCT00430105|"     A comparison of intermittent pulsed cyclophosphamide to daily oral cyclophosphamide for the     treatment of ANCA-associated systemic vasculitides with kidney involvement.      Performed by the European Vasculitis Study group.   "
197133|NCT00429286|"     Breast cancer patients experience functional limitations related to the cancer and treatment     side effects. Early functional limitations affect short- and long-term quality of life, and     may lead to long-term complications. Patients living in rural areas are at particular risk     because they do not have easy access to services. Therefore, early intervention is indicated     to have an impact on the overall public health. Problem solving training (PST) is a     standardized manual driven intervention that may be ideally suited to assist breast cancer     patients to preserve their valued activities and to comply with recommended symptom     management regimens (e.g., physical therapy, aerobic exercise and relaxation/guided imagery)     that improve function. Telephone-based PST provided from a centralized location (such as the     comprehensive cancer center) may improve access and outcomes in a cost-effective manner. We     propose to conduct a feasibility study of a PST intervention with 30 rural breast cancer     patients undergoing adjuvant treatment randomly assigned to PST or to usual care. The     intervention group will receive weekly phone-based PST sessions for six consecutive weeks.     The specific aims of this R03 small grant application are to:1) Test the feasibility of     enrolling and retaining newly diagnosed breast cancer patients in a clinical trial to assess     telephone-based PST. 2) Collect preliminary data on outcome measures of function to determine     effect size estimates that will inform power analyses for a full scale randomized controlled     study. Primary outcome measures will be acceptance rates for enrollment in the study,     retention rates across both intervention arms, and satisfaction levels with the PST     intervention. Assessments will be conducted at baseline, and at six weeks (end of PST     intervention) and 3 months following baseline. The long-term goal of this line of     investigation is to develop practical, widely applicable rehabilitation models of care to     preserve function and decrease distress in cancer patients undergoing treatment.   "
197134|NCT00429299|"     Evaluate the activity of Trastuzumab, Lapatinib, and a combination of both agents with     chemotherapy in the preoperative (neoadjuvant) treatment of early breast cancer.   "
197136|NCT00429325|"     Every year more than 4 billion cases of diarrhea occur worldwide culminating in about 2.5     million deaths, almost all in the developing nations. Reliable diagnosis of patients with     acute infectious diarrhea which could be appropriately managed with antibiotics at     presentation still remains a formidable challenge to the clinicians. To address this issue of     predicting microbiological infectious etiology for diagnosing acute infectious diarrhea, we     would evaluate stools from all patients with acute diarrhea with culture, Guaiac based fecal     occult blood test (FOBT), Calprotectin and lactoferrin assays simultaneously. This would be     the first study evaluating fecal calprotectin as a diagnostic marker in acute diarrhea   "
197137|NCT00429338|"     The objective of this study is to evaluate the feasibility of 3T magnetic resonance     spectroscopic imaging (MRSI) of the prostate in improving the spectral resolution, using a     perfluorocarbon compound (PFC)-filled endorectal coil.      Specific Aim 1: To compare the spectral quality, measured in Hz (linewidth), of 3T MRSI     performed with an air-filled endorectal coil (AIR-MRSI) and a PFC-filled endorectal coil     (PFC-MRSI).      Specific Aim 2: To compare the quality of spectra of PFC-MRSI by grading the overall quality     of MRSI data of each patient subjectively as being excellent, good, fair, poor, and     non-diagnostic, based on the status of subjective spectral resolution of Cho, Cr and Po     peaks, signal to noise ratio (SNR), baseline distortion, and fat contamination.   "
197138|NCT00429351|"     This research may explain whether a shortage of three special compounds called aromatic amino     acids is responsible for the severe illness and high death rate of children with the     kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in     the treatment diet will speed up recovery from this condition. We propose that decreased     availability of the aromatic amino acids may be the reason why children with kwashiorkor are     sicker and more difficult to treat.   "
197139|NCT00429364|"     Marfan syndrome is a hereditary connective tissue disorder. Many individuals with this     condition die because of the associated heart and blood vessel abnormalities. This study will     compare the effectiveness of two medications, losartan and atenolol, at slowing aortic root     enlargement in individuals with Marfan syndrome.   "
197140|NCT00429377|"     This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study     in steroid refractory Lupus Nephritis patients.   "
197141|NCT00429390|"     this study was conducted to assess the insulin resistance indices in the subjects undergoing     Ramadan fasting (diet which consisted of two meals at 12 hours intervals)for a thirty days     period.   "
197142|NCT00429403|"     Primary Objective:        -  To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian          function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for          primary invasive breast cancer by documenting persistence or resumption of regular          menses.      Secondary Objectives:        -  To determine the incidence of pregnancy and the effect for participants' quality of life          (QOL) after chemotherapy.        -  To determine the overall survival and disease-free survival times of study participants.   "
197143|NCT00429416|"     The purpose of this research study is to determine if an experimental agent, LLME can     decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following blood     (hematopoietic) stem cell transplantation   "
197144|NCT00429429|"     Currently, when a food allergy is diagnosed, the standard of care is strict avoidance of     the allergic food and ready access to self-injectable epinephrine. Yet, accidental ingestions     do occur. Unfortunately, for a ubiquitous food such as peanut, the possibility of an     inadvertent ingestion is great. It is estimated that over 50% of individuals who are allergic     to peanuts will have an accidental reaction to peanuts over a 2-year period. The purpose of     this study is to determine if peanut sublingual immunotherapy (SLIT) reduces the number     and/or symptoms of accidental peanut ingestion in peanut allergic subjects. We would     anticipate that the subjects on the peanut SLIT protocol would experience few adverse effects     with accidental peanut ingestion over the course of the two years of SLIT. The primary     endpoint to evaluate the effectiveness of SLIT will be a negative DBPCFC to peanuts (8 grams)     at the completion of the two years of the study.   "
197145|NCT00429442|"     A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on     Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated     with Copaxone for at least 3 months   "
197146|NCT00429455|"     Primary Objective:      - To understand the importance of receiving information on fertility- and menopause-related     treatment effects for female patients undergoing hematopoietic stem cell transplantation.   "
197147|NCT00429468|"     The purpose of this research study is to determine if varying strengths of ethanol affect the     drug level and safety profile of Vicodin® CR.   "
197150|NCT00429507|"     Primary objectives:      - To determine the time to progression in subjects with breast cancer metastatic to bone only     treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT).      Secondary objectives:        -  To determine the overall survival at one year.        -  To determine the efficacy of 153Sm-EDTMP at 6 months.        -  To assess pain in subjects treated with 153Sm-EDTMP.        -  To determine the safety of 153Sm-EDTMP.   "
197151|NCT00429520|"     Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are     followed-up for up to 36 weeks.   "
197152|NCT00429533|"     The purpose of this 12-month study was to determine the efficacy of dapsone as a     glucocorticoid-sparing agent in maintenance phase pemphigus vulgaris.   "
197153|NCT00429546|"     This study will develop and evaluate the effectiveness of an intervention designed to assist     HIV-infected mothers of young children in determining whether and how to appropriately     disclose their HIV serostatus to their children.   "
197154|NCT00429559|"     Topotecan and gemcitabine are drugs globally registered for recurrent ovarian carcinoma. This     trial will determine the maximum tolerated dose and the efficacy of this combination     administered weekly in patients with platinum -resistant ovarian cancer.   "
197155|NCT00429572|"     Primary Objectives:        1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC)          transplantation in patients with recurrent or metastatic breast cancer.        2. To determine the success rate (complete remission without severe toxicity or death) at          100 days after the transplant and long-term progression free survival (PFS) rate.        3. To examine the graft vs. breast cancer effect of allogeneic PBPC transplantation.   "
197159|NCT00429637|"     Given the possible prognostic relationship between exhaled breath condensate pH and clinical     symptoms, it is quite plausible that exhaled breath condensate pH can prove useful in the     intensive care unit. For example, if exhaled breath condensate pH falls prior to the onset of     clinical symptoms, it is likely that it can be useful as an early marker, heralding the onset     of various inflammatory lung diseases. Specifically, exhaled breath condensate pH could be     used as a safe, non-invasive screening tool for Ventilator Associated Pneumonia. Similarly,     just as changes in exhaled breath condensate pH might predict the onset of disease, exhaled     breath condensate pH changes might also mark the progression or resolution of disease (e.g.     alerting clinicians to possible readiness for extubation). Although such notions are     hypothetical, they are beginning to be supported by anecdotal evidence.   "
197160|NCT00429650|"     The major challenge in obesity treatment is not producing weight loss but in preventing that     weight from being regained. There are many different methods to lose weight, but there are no     recommendations for how you can best achieve long-term weight loss maintenance. Despite the     method used to reduce one's body weight, very few of these individuals are able to keep their     weight off permanently. This project aims to identify how much activity is necessary to     prevent weight regain after weight loss.   "
197161|NCT00429663|"     This study looks at two (2) types of surgical treatments and hopes to answer the question,     which is the best way to surgically treat a distal femur fracture? Both procedures being     studied are standard of care (used routinely) and use FDA approved devices. All medical and     surgical treatment will be the same for participants as non-participants.   "
197162|NCT00429676|"     The goal of this study is to determine whether haloperidol reduces the time on the breathing     machine in critically ill patients with delirium.   "
197163|NCT00429689|"     Subjects will be 1000 men meeting the following inclusion criteria: 1) male, age 18-65 years;     2) meeting DSM-IV criteria for major depressive disorder within the past one year, with a     HAM-D score >12.      Subjects will be excluded if they exhibit 1) a substance abuse or dependence disorder within     the past year; 2) current psychotic symptoms; or 3) a history of bipolar disorder.      Procedure      After informed consent, eligible patients will have blood drawn for serum hormone levels;     cortisol, DHEA-S and testosterone or they will provide a salivary sample for measurement of     hormone levels.      We will also test hormone level form 1000 healthy males (from blood or saliva) at the same     age for comparison.   "
197164|NCT00429702|"     RATIONALE: Diphenhydramine, lorazepam, and dexamethasone may help lessen or prevent nausea     and vomiting in patients treated with chemotherapy. It is not yet known whether     diphenhydramine, lorazepam, and dexamethasone are more effective than standard therapy in     treating nausea and vomiting caused by chemotherapy.      PURPOSE: This randomized phase II trial is studying diphenhydramine, lorazepam, and     dexamethasone to see how well they work compared with standard therapy in treating nausea and     vomiting caused by chemotherapy in young patients with newly diagnosed cancer.   "
197198|NCT00422006|"     Experimental results are strongly suggesting that PCSK9 and FXR could occur in the     physiopathology of human joined dyslipidemia. But no data in the literature can validate the     potential role of these two genes in the lipidic and glucidic metabolism control in     physiopathological situations. This protocol is based on the hypothesis that the expression     levels of PCSK 9 and FXR are modified for some patients suffering from insulin resistance and     dyslipidemia.   "
197199|NCT00422019|"     The purpose of this study is to evaluate the effectiveness and safety of AMG 102 in patients     with Advanced Renal Cancer.   "
197165|NCT00429715|"     Development of a safe and effective vaccine against leishmaniasis started more than 10 years     ago under WHO/TDR supervision. An autoclaved L. major vaccine (ALM) mixed with BCG has been     tested in human in Iran, Pakistan and Sudan. Long term follow up of the vaccinees showed no     untoward reactions except the skin reaction at the site of injection. The efficacy results of     ALM was not satisfactory. In order to enhance immunogenicity of the vaccine, ALM was adsorbed     to alum (Aluminum hydroxide). Alum-ALM plus adjuvant showed to induce protection in Rhesus     monkeys against cutaneous leishmaniasis and in Languor monkeys against visceral     leishmaniasis. Two trials of a single injection of different doses of Alum-ALM mixed with     1/10th of normal dose of BCG was carried out in healthy volunteers from a non endemic area of     Sudan. The safety/immunogenicity parameters of the volunteers were closely monitored and the     results showed that side effects were minimal and confined to the site of injection in the     form of mild local pain, induration and ulceration, all associated with BCG vaccination. The     immunogenicity results showed the strongest immune response seen in any Leishmania vaccine     trials so far. It seems that this new formulation is an appropriate candidate for further     development. Inoculation with live virulent Leishmania to produce a lesion for the purpose of     preventing natural infection is known as leishmanization. The induced lesion heals and the     person is usually protected against further infections. This method of prevention was     practiced for centuries in the region. In this study volunteers with no response to     leishmanin will be injected twice (30 days apart) with Alum-ALM 200 ug + 1/10 of BCG (n = 50)     or BCG (n = 50) or BCG diluent alone (n = 50) as control. All volunteers will be leishmanized     on day 60 post vaccination. In this trial, volunteers are protected either by vaccine or by     leishmanization. The leishmanized volunteers will be visited by weekly and the development     and healing process of the lesion will be monitored until complete healing of every     volunteer. The immune responses of the volunteers will be evaluated. Vaccine efficacy is     defined by the percent reduction in the number of volunteers developing a lesion following     leishmanization as compared to controls on days 240.   "
197166|NCT00429728|"     This study will investigate the effect of smoking on the metabolism of a single oral dose of     GW876008.   "
197167|NCT00429754|"     The purpose of the study is to investigate whether there is an interaction occurs between     etoposide and aprepitant in patients with testis carcinoma treated with the standard BEP     regimen.      Also to determine how long treatment with aprepitant is necessary in BEP regimen for 5     consecutive days.   "
197168|NCT00429767|"     The purpose of this study is to determine whether maintenance on different oral doses of     sustained release d-amphetamine (SR-AMP) combined with constant-dose sublingual buprenorphine     (BUP) is safe and well tolerated and decreases self-administration of cocaine alone or     combined with hydromorphone (HYD). Secondary aims are to determine whether SR-AMP attenuates     the subjective and physiological effects of cocaine during drug sampling periods prior to     choice opportunities.   "
197178|NCT00416390|"     RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming,     growing, or coming back. Eating a diet high in lycopene, a substance found in tomatoes and     tomato products, may keep cancer from forming or growing. Collecting and storing samples of     blood from patients with cancer to study in the laboratory may help doctors learn more about     changes that may occur in DNA and identify biomarkers related to cancer.      PURPOSE: This randomized clinical trial is studying how well lycopene works in treating     patients with prostate cancer or benign prostatic hyperplasia.   "
197722|NCT00435513|"     Genetic variations, i.e. polymorphisms, may be associated with gender dysphoria, e.g.     transsexualism. This study aims to identify such variations.   "
197169|NCT00429780|"     Development of a safe and effective vaccine against leishmaniasis started more than 10 years     ago under WHO/TDR supervision. An autoclaved L. major vaccine (ALM) mixed with BCG has been     tested in human in Iran, Pakistan and Sudan. Long term follow up of the vaccinees showed no     untoward reactions except the skin reaction at the site of injection. The efficacy results of     ALM was not satisfactory. In order to enhance immunogenicity of the vaccine, ALM was adsorbed     to alum (Aluminum hydroxide). Alum-ALM plus adjuvant showed to induce protection in Rhesus     monkeys against cutaneous leishmaniasis and in Languor monkeys against visceral     leishmaniasis. Two trials of a single injection of different doses of Alum-ALM mixed with     1/10th of normal dose of BCG was carried out in healthy volunteers from a non endemic area of     Sudan. The safety/immunogenicity parameters of the volunteers were closely monitored and the     results showed that side effects were minimal and confined to the site of injection in the     form of mild local pain, induration and ulceration, all associated with BCG vaccination. The     immunogenicity results showed the strongest immune response seen in any Leishmania vaccine     trials so far. It seems that this new formulation is an appropriate candidate for further     development. Inoculation with live virulent Leishmania to produce a lesion for the purpose of     preventing natural infection is known as leishmanization. The induced lesion heals and the     person is usually protected against further infections. This method of prevention was     practiced for centuries in the region. In this study volunteers with response to leishmanin     will be injected twice (30 days apart) with Alum-ALM 200 ug + 1/10 of BCG (n = 50) or diluent     alone (n = 50) as control. All volunteers will be leishmanized on day 60 post vaccination. In     this trial, volunteers are protected either by vaccine or by leishmanization. The     leishmanized volunteers will be visited by weekly and the development and healing process of     the lesion will be monitored until complete healing of every volunteer. The immune responses     of the volunteers will be evaluated. Vaccine efficacy is defined by the percent reduction in     the number of volunteers developing a lesion following leishmanization as compared to     controls on days 240.   "
197170|NCT00429793|"     This phase II trial is studying the side effects and how well temsirolimus works in treating     patients with refractory or recurrent ovarian epithelial cancer, fallopian tube cancer, or     primary peritoneal cancer. Temsirolimus may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth.   "
197171|NCT00429806|"     The purpose of the study is to evaluate the systemic bioavailability of DHEA and its     metabolites and the pharmacokinetics of vaginal suppositories at four different DHEA     concentration.   "
197172|NCT00429819|"     We hypothesize that glaucoma patients demonstrate an impaired retinal vascular response to     the flicker stimulus, and that this disturbance is predictive of the progression of     glaucomatous damage.      The response of a major temporal superior and inferior retinal artery and vein to a 60     seconds 12.5 Hz flicker light stimulation in 50 glaucoma patients, 50 ocular hypertensives     and 50 controls (using the Retinal Vessel Analyzer) and to investigate how intraocular     pressure relates to neurovascular coupling. In addition, 50 glaucoma patients and 50 ocular     hypertension patients will be followed for 3 years for functional (visual field, automated     perimetry with Octopus device) and morphological (retinal nerve fiber layer thickness,     Optical Coherence Tomography Stratus (OCT) device) glaucomatous damage progression, in order     to test the predictive power of the retinal vascular flicker response for glaucoma     progression.   "
197173|NCT00429832|"     This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron     and promethazine, in the Emergency Department.   "
197174|NCT00429845|"     Highly active antiretroviral therapy (HAART) in HIV-positive patients is associated with the     development of dyslipidemia, a risk factor for cardiovascular events. The objective of this     study was to evaluate the effect of dietary intervention in individuals who start HAART.   "
197175|NCT00416351|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and     to see how well it works in treating patients with T-cell or natural killer-cell lymphoma     that has relapsed or not responded to previous treatment.   "
197200|NCT00422032|"     The goal of this clinical research study is to compare the effectiveness of 2 different doses     of the drug clofarabine that can be given on a weekly schedule for the treatment of     Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared.      Primary Objective: Compare the response rates of two dose schedules of clofarabine in MDS.      Secondary Objective: Compare response durations, survivals and side effects of the two     schedules.   "
197201|NCT00422045|"     The primary objective of this study is to assess whether or not low level laser therapy     (LLLT) decreases pain in post-operative orthopedic patients following lumbar fusion surgery.   "
199373|NCT00457236|"     This study is a prospective, single-center evaluation of the impact of the variability in     platelet response after loading with clopidogrel on the peri-interventional risk of patients     undergoing PCI.   "
197176|NCT00416364|"     There are a variety of methods to repair inguinal hernias. Each has its advocate and may     confer advantages to individual patients. Postoperative pain, convalescence, recurrence, and     economics have all been evaluated however none in a randomized blinded fashion. Recently,     investigators have attempted to address some of these concerns with new prosthetic materials.     The preferred method of repair currently employs a tension free technique using mesh     prosthesis. The approach as advocated by Lichtenstein involves reinforcing the floor of the     inquinal canal with an onlay mesh. Newer approaches use a double layer mesh that reinforces     the floor in a preperitoneal and onlay technique (Prolene Hernia System) while obliterating     the internal inguinal ring or by the Mesh Plug repair (bioresorbable or permanent) which     reinforces the inguinal floor with an onlay mesh while obliterating the internal inguinal     ring. Currently no study has compared these techniques for ease of performance, postoperative     pain, convalescence, quality of life, or cost in a randomized double blinded fashion. NMCP is     uniquely qualified to compare these repairs prospectively and blinded to best assess the most     cost effective approach which causes the least pain. A prospective double-blinded randomized     trial comparing the Lichtenstein onlay mesh technique to Prolene Hernia Sytem (PHS), Mesh     Plug Repair (MPR), or Gore Bioresorbable plug for postoperative pain, duration of     convalescence, cost, impact on quality of life and ease of performance is proposed. Impact on     quality of life will be assessed serially with the SF 12 which is a validated survey used     with serial measures in the acute setting.   "
197177|NCT00416377|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more cancer cells.      PURPOSE: This clinical trial is studying how well radiation therapy or combination     chemotherapy work in treating young patients with Hodgkin's lymphoma.   "
197206|NCT00422110|"     This study will evaluate the effectiveness and safety of seletracetam when it is used in     addition to other anti-epileptic medications by patients with partial onset seizures. It will     also help to determine the best dose to use.   "
197179|NCT00416403|"     RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the     laboratory may help doctors learn how fluvastatin effects biomarkers related to breast     cancer.      PURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in     women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.   "
197180|NCT00416429|"     RATIONALE: Medroxyprogesterone may help shrink or slow the growth of kidney cancer.     Interferon may interfere with the growth of tumor cells. Aldesleukin may stimulate white     blood cells to kill tumor cells. It is not yet known whether giving medroxyprogesterone,     interferon, or aldesleukin alone is more effective than giving interferon together with     aldesleukin in treating kidney cancer.      PURPOSE: This randomized phase III trial is studying medroxyprogesterone, interferon, or     aldesleukin to see how well they work when given alone compared to interferon combined with     aldesleukin in treating patients with metastatic kidney cancer.   "
197181|NCT00416442|"     This study is designed to evaluate the safety, tolerability and pharmacokinetics of single     and multiple-dose escalation of RSV604 administered intravenously in healthy subjects.   "
197182|NCT00421798|"     This study will test a method of detecting tuberculosis-causing bacteria that are resistant     to current medication treatments. Blood samples will be collected from patients from 3 sites     and 3 mainly Hispanic populations in Texas, Mexico, and Colombia. Up to 780 males and     females, ages 18-85 years, will participate. The study population will consist of 390 people     with any of 3 forms of tuberculosis (TB) and 390 people who are either healthy or with a     disease initially thought to be one of these 3 forms of TB but then ruled out. Volunteers     will only be contacted, invited to participate and interviewed at the beginning of their     evaluation for possible TB.The study team will follow up with the health department to     determine if the volunteer was indeed diagnosed with TB, and with the laboratory to determine     the results of TB tests at diagnosis and during the course of treatment.   "
197183|NCT00421811|"     N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor     cells, is increased as cancer progresses. ADH-1 blocks N-cadherin. This study will test the     safety and effects of the combination ADH-1 with Normothermic Isolated Limb Infusion of     Melphalan in subjects with locally advanced malignant melanoma.   "
197184|NCT00421824|"     Primary:        -  To assess complete pathological response rate of both strategies.      Secondary:        -  Safety profile        -  To assess downstaging rate of both strategies.        -  To compare relative dose intensity of oxaliplatin and capecitabine of both strategies        -  To compare time to progression and overall survival of both strategies.   "
197185|NCT00421837|"     Influenza (the flu) is a leading cause of respiratory (breathing) illness that leads to     sickness and death during the winter months. A better understanding of why certain people get     the flu or get sicker with the flu than other people is important for developing improved     vaccines and treatments. This study will look at the genetic makeup (determines each person's     specific characteristics and traits) of 50 patients, older than 50, who were hospitalized     with flu at Vanderbilt University during the 2006-2007 flu season. Their genetic makeup will     be compared with the genetic makeup of 50 people who are not related but were in close daily     contact with the flu patient and were not infected with flu virus. The study staff will     collect a blood sample (contains genetic material) from each participant (flu patients and     their contacts) for comparison. Flu patients will have completed a health survey as part of     the previous study, and their contacts will complete a shorter version of this survey.   "
197202|NCT00422058|"     This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the     efficacy of liraglutide to induce body weight loss and the purpose of the extension is to     evaluate the long term safety and tolerability of liraglutide.      Trial has the following trial periods: A 20-week randomised, double-blind,     placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open     label orlistat comparator arm followed by an 84 week extension period.   "
197186|NCT00421850|"     The costs of diabetes care (in health care dollars & human suffering) in the United States     are second only to mental illness. Randomized control trials & observational studies have     shown that glycemic control is predictive of the onset & severity of complications from     diabetes and costs of care. In addition, a significant percentage of costs associated with     diabetes can be reduced or delayed by appropriate diagnosis, preventive strategies, &     management. The Planned Care Model (advocated by the Institute for Healthcare Improvement)     has shown success in demonstrating improved practice performance and patient outcomes during     a limited pilot in our clinical practice. We are proposing to generalize the Planned Care     Model, to assess the value of planned care for all people with diabetes. The Planned Care     Model will be implemented at each practice site and will consist of a structured     communication schema between the patient and the primary health care team, to improve care     for people with diabetes. Traditional care will be defined as the traditional system of care     for patients prior to their participation in the Planned Care Model. It is hypothesized that     this Planned Care Model will improve compliance with appropriate care guidelines and improve     short and long term health outcomes (metabolic, satisfaction, morbidity, mortality and     healthcare utilization). In conjunction with this study, providers at each of the practice     sites will be randomly assigned to a structured communication with specialty care, referred     to as UNITED Planned Care (Use of Networks, Informatics, Telemedicine, and Education in     Disease Management). This communication schema will only be possible once the assigned     provider?s patient is participating in the Planned Care Model. The UNITED Planned Care model     will include point-of-care evidence based messages and specialty advice determined by     performance gaps and outcomes for the patient. UNITED Planned Care is hypothesized to have     the greatest impact on short & long term health outcomes.   "
197187|NCT00421863|"     Multicenter, prospective, randomised, open study comparing the effect of the following two     strategies in hypertensive subjects > 55 years and poorly controlled (systolic blood pressure     >= 150 mmHg) by antihypertensive treatment:        -  usual strategy: reduction of systolic blood pressure to below 140 mmHg, independently of          diastolic blood pressure levels;        -  intensive strategy: reduction of systolic blood pressure to below 130 mmHg,          independently of diastolic blood pressure levels.      During the initial run in period two qualifying visits at distance of 7-14 days will be     carried out to establish whether blood pressure remains uncontrolled (systolic blood pressure     >=150 mmHg)by current drug treatment. At the end of the second visit eligible patients will     be admitted to the study and the following examinations will be carried out: clinical visit,     routine laboratory tests, 12-lead ECG. At this point eligible patients will be randomised to     one of the two blood pressure goals outlined above.      Subsequent clinical visits will be carried out at 4 month-intervals up to the end of the     study (4, 8, 12, 16, 20, 24 months).   "
197207|NCT00422123|"     The purpose of this study is to determine the safety and efficacy of sustained-release     quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3     weeks.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
197188|NCT00421876|"     Cardiac rehabilitation programmes are a proven treatment for individuals with recent     myocardial infarction, resulting in reduced morbidity and mortality compared to usual care.     Unfortunately, following completion of a cardiac rehabilitation programme, risk factors and     lifestyle behaviours may deteriorate. The GOSPEL study investigates the benefits of a     programme of continued educational and behavioural intervention to achieve optimal long-term     secondary prevention goals.   "
197189|NCT00421889|"     The study seeks to assess the safety, pharmacodynamics, pharmacokinetics and efficacy of     belinostat (PXD101) administered in combination with carboplatin or paclitaxel or both in     patients with solid tumours followed by maximum tolerated dose (MTD) expansion (phase II) in     ovarian and bladder cancer patients      The clinical trial is now in the MTD (phase II) portion of the study enrolling bladder cancer     patients. Enrollment of ovarian patients is complete.   "
197190|NCT00421902|"     Patients with prostate cancer who are / were treated with hormonal treatment and developed     hot flashes as a side effect are offered Acupuncture as an investigational intervention. The     treatment is performed twice a week for four weeks, then once a week for the following six     weeks   "
197191|NCT00421915|"     The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice     weekly) with that of placebo based on the percentage of patients who achieve the Assessment     in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.   "
197192|NCT00421928|"     The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety     of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250     mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the     knee, in comparison with placebo and Oxycodone Controlled Release (CR).   "
197193|NCT00421941|"     The purpose of this study is to evaluate the clinical applicability of an enteral tube     feeding formula containing fish oil and prebiotics in a critical care population.   "
197194|NCT00421954|"     This open-label study will assess the medication Geodon® (Ziprasidone) in pediatric patients,     aged 13-17, diagnosed with psychotic disorder. Eligible adolescents will receive Geodon® for     7 weeks and stay at the NYSPI Children's Day Unit (CDU) during the day. If clinically     appropriate, they may also stay at the New York State Psychiatric Institute (NYSPI)     Schizophrenia Research Unit (SRU) inpatient facility.   "
197195|NCT00421967|"     Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain.     Although epidural treatment provides good and reliable postoperative pain relief after THA,     it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed     mobilization.      The challenge of new analgesic regimes is to reduce the occurrence of side effects while     maintaining adequate pain relief and maximum muscle control. A relatively new method to     provide postoperative pain relief after TKA is local infiltration analgesia combined with     single-shot injection(s) or continuous infusion of local anesthetics into the surgical site.     As local infiltration analgesia combined with continuous intraarticular infusion compared     with continuous epidural infusion has not been evaluated, our study was designed to determine     whether this technique could enhance analgesia and improve patient outcome after TKA. This     study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with     local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with     continuous intraarticular infusion of Ropivacaine and Ketorolac.   "
197196|NCT00421980|"     The primary objective of this study was to determine the long-term safety of etanercept in     adults with AS who had completed study 0881A3-311-EU.   "
197197|NCT00421993|"     This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of     treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening     (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment     evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a     subject should remain the same during the study.      The primary objective is to demonstrate the superiority in efficacy and assess safety of     Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene     Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide     Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12     weeks.   "
197203|NCT00422071|"     This study will use transcranial magnetic stimulation (TMS) to determine whether the activity     in the brain when someone wins something affects the part of the brain that controls     movement. Studies have shown that the brain releases signals to mark rewards for certain     behavior, like the activity the brain generates when an animal receives food or drink after     performing a certain action. This study will look for a way to detect this kind of signal in     humans.      Healthy volunteers between 18 and 60 years of age are eligible for this study. Participants     undergo TMS during two experiments slot machine stimulation and key sequence (see below). For     TMS, a wire coil is held on the subject s scalp. A brief electrical current is passed through     the coil, creating a magnetic pulse that stimulates the brain. The stimulation may cause     twitching in muscles of the face, arm or leg, and there may be a pulling sensation on the     skin under the coil. The effect of TMS on the muscles is detected with small metal disk     electrodes taped onto the skin of the arms or legs.      The stimulation strength needed to activate the hand muscles is determined at the beginning     of each experiment. To do this, the subject sits with his or her arms and hand relaxed.     Magnetic pulses of varying strengths are applied in order to find the right strength. Also, a     series of 45 pairs of magnetic pulses is administered so close to each other that they     produce only one movement. Measurements of the movements generated serve as a baseline for     comparison with movements generated during the experiments.      Slot Machine Simulation      Subjects play a computer game similar to a slot machine. They press a button to start the     game and watch as three barrels of the machine spin into place. Subjects can win $0.25, $1or     $5 if all three barrels match when they stop spinning. If all three barrels do not match,     subjects do not win any money, except in rare instances, when they are awarded money even     when all three barrels do not match. In one trial in this experiment, subjects receive     transcranial magnetic stimulation after they see the second barrel stop spinning. In another     trial, they receive the stimulation after the third barrel stops spinning.      Key Sequence      Subjects see a letter on a computer screen and press a combination of the three keyboard keys     G, H, and J. If they press the keys in the right order and under the time limit, they win $1.     At some point, the letter displayed changes, and the subjects must guess a new combination to     earn money. Each of the letters corresponds to its own combination of key presses. A few     moments after the subjects see whether they pressed the keys in the right order, they receive     TMS.   "
197204|NCT00422084|"     The purpose of this study is to compare the efficacy and safety of the fixed combination of     pyronaridine artesunate (180:60 mg) with that of Coartem® (artemether lumefantrine) in     children and adults with acute uncomplicated P falciparum malaria.   "
197205|NCT00422097|"     This study will determine the maximum tolerated dose of oral ixabepilone administered for 5     successive days every 21 days in participants with advanced cancer. The safety, tolerability,     and pharmacokinetics of ixabepilone in the body will be studied. In addition, this study will     assess preliminary evidence of the effect of food and famotidine on the pharmacokinetics of     oral ixabepilone.   "
197208|NCT00422136|"     The goal of this study is to identify the genes that contribute to susceptibility to     recurrent/persistent middle ear disease. Five hundred families with at least 2 children who     have undergone tympanostomy tube insertion will be enrolled. A blood sample will be obtained     from the children who had tubes and any available parent (at least 1), as well as any     siblings without significant histories of middle ear disease.   "
197209|NCT00422149|"     To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction     in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from     IgE mediated allergic complaints triggered by grass pollen.   "
197210|NCT00422162|"     An eight-week, randomized, double blind, two parallel groups, study to assess clinical     response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for     severe depression.   "
197211|NCT00422175|"     The purpose of this study is to assess the safety, tolerability, and effect of oral BAF312 on     bodily functions as well as the body's absorption, distribution, metabolism, and excretion of     BAF312 in healthy volunteers   "
197212|NCT00422188|"     The purpose of this research is to compare the safety and effectiveness of 4 different     concentrations of deoxycholic acid injection against a placebo in the treatment of     superficial lipomas.   "
197213|NCT00422201|"     This study will evaluate whether the drug mifepristone can improve the symptoms of Cushing's     syndrome in people with ectopic adrenal corticotrophin hormone (ACTH) secretion. Cushing's     syndrome occurs when the adrenal glands produce too much cortisol, a hormone that helps to     regulate the body's use of salt and food. Excessive cortisol is usually the result of too     much ACTH, the hormone that causes the adrenal glands to make cortisol. The extra ACTH is     made either by a tumor in the pituitary gland (called Cushing's disease) or by a tumor     somewhere else (called ectopic ACTH secretion). Mifepristone blocks the action of cortisol in     the body. The drug has been used safely to treat a few people with Cushing's syndrome and     patients with certain kinds of cancer, gynecological diseases and psychiatric disorders.      People between 18 and 85 years of age with Cushing's syndrome caused by EXCESS ACTH secretion     may be eligible for this study. Candidates are admitted to the hospital for evaluation to     confirm Cushing's syndrome and to determine its cause. The evaluation includes blood and     urine tests, imaging tests, dexamethasone and corticotropin-releasing hormone tests and     inferior petrosal sinus sampling. Patients determined to have Cushing's syndrome due to     ECTOPIC ACTH secretion undergo imaging studies (CT, MRI and a nuclear medicine scan) and     begin mifepristone therapy.      Participants remain in the hospital for the following tests and procedures:        -  Physical examination, electrocardiogram (EKG) and blood and urine tests        -  Completion of medical questionnaires        -  DEXA scan to determine bone mineral density and body composition        -  Glucose tolerance test        -  Urine pregnancy test and ultrasound to measure uterine lining thickness (for women)      Patients take mifepristone by mouth 3 times a day. The dose is increased every week or so     until symptoms improve or the highest dosage allowed is reached. Patients may remain in the     hospital for all or part of the dose-finding part of the study. During this period (usually 2     to 4 weeks), blood pressure, glucose tolerance and blood chemistries are measured and EKG and     urinalysis done every 5 to 14 days. When the mifepristone dose is stable patients remain on     that dose for at least 2 weeks and are then re-evaluated. Patients then return to the     hospital for evaluations every 3 months. Those who do well on the drug may continue to take     it for up to 12 months.   "
197214|NCT00422214|"     The purpose of this study is to determine the safety and efficacy of sustained-release     quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression     for 8 weeks.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
197215|NCT00422227|"     The purpose of this study is to compare the efficacy of etanercept with usual     disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe     rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.   "
197244|NCT00422604|"     The safety, tolerability, pharmacokinetics and pharmacodynamics/efficacy profiles of two     different doses of GSK233705 will be compared with 2 active comparators and placebo, all     medication delivered via dry powder inhaler.   "
197245|NCT00422617|"     An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly     intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis   "
197216|NCT00422240|"     This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of     treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening     (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment     evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a     subject should remain the same during the study.      The primary objective is to demonstrate the superiority in efficacy and assess safety of     adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene     topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide     monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12     weeks.   "
197217|NCT00422253|"     We hypothesize that reduction in dietary advance glycation endproducts (AGE) intake will     increase insulin sensitivity and normalise insulin secretion in overweight and obese     individuals through reduction of chronic low grade inflammation.      We propose to test this hypothesis by performing euglycemic hypeinsulinemic glucose clamp and     intravenous glucose tolerance test before and after low AGE diet and normal Australian diet     in a cross-over design. This study will provide information relevant to the development and     prevention of type 2 diabetes.   "
197218|NCT00422266|"     The incidence of chronic degenerative diseases, especially cardiovascular disease (CVD), is     high world over and especially in India. High blood cholesterol and triglyceride levels are     known to be important risk factors for CVD. There is a strong body of evidence for the     beneficial effects of plant sterols on blood total and LDL-cholesterol and omega-3 fatty     acids from fish on blood triglycerides. However, the combined benefits of consuming both     plant sterols and omega-3 fatty acids from fish oil on blood cholesterol and triglycerides     has not been investigated previously, except in one study where the methodology used was not     the most appropriate for testing such a combination. In addition, most studies on plant     sterol efficacy realised so far were done in Western countries. The present study will     investigate the efficacy of plant sterols and omega-3 fatty acids from fish oil on improving     the cardiovascular risk profile of Indian adults with dyslipidemia.      It is expected that, after 4 weeks of intervention, men consuming both plant sterols and     omega-3 fatty acids from fish oil will have a lower cardiovascular risk profile than men     receiving only plant sterols or only fish oil or none of these dietary supplements.   "
197219|NCT00422279|"     The purpose of the study is to evaluate implant stability and stimulate clinically relevant     horizontal and vertical new bone formation around Nobel Biocare's Bone Inductive Implant.   "
197324|NCT00423657|"     The purpose of this study is to determine whether ceftaroline is effective and safe in the     treatment of complicated skin infections in adults.   "
197220|NCT00422292|"     This is a modified single-blind, randomized, parallel-group, comparative, multicenter study     to test Menactra vaccine in toddlers.      Primary Objectives:        -  To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella          (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine.        -  To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when          administered alone or concomitantly with Menactra vaccine.      Observational Objectives:      Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6     months after the last study vaccination[s]) in subjects in the study groups.      Immunogenicity:      - To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days     after the first and second Menactra vaccine administration in a subset of subjects in the     first study group.   "
197221|NCT00422305|"     The purpose of this study is to evaluate the growth of the lung and how easily gas can be     taken up by the lung in healthy infants born at full term without any breathing problems and     infants born prematurely.   "
197222|NCT00422318|"     The study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and     (II) to test the effect of lowering UA by uricosuric treatment in CHF.   "
197223|NCT00422331|"     The purpose of this study is to determine whether Lithium is safe and effective in the     treatment of Bipolar I Disorder subjects with symptoms of acute mania.   "
197224|NCT00422344|"     The purpose of this study is to test the safety of RAD-001 and Sunitinib given in combination     for renal cell cancer. We also want to find out what effects (good and bad) the combination     of RAD-001 and Sunitinib have on you and your tumor.      RAD001 is a pill that works by shutting down some of the pathways in the cell that make     tumors grow. Sunitinib is a pill that works by shutting off the signal in the cancer cells     that tell the cells to grow blood vessels. Without this signal, the blood vessels to the     tumors shrink down.   "
197225|NCT00422357|"     Diabetes mellitus is the most common metabolic disorder worldwide. Some herbs are     traditionally used in treatment of type 2 diabetes mellitus (T2DM). Urtica Dioica (UD) or     stinging nettle is traditionally used in Morocco, Turkey, Brasil, Jordan and with much     frequency in northern Iran.      Studies on animal models along with in vitro studies has shown hypoglycemic effect for     aqueous extract of UD.      This study aimed to investigate hypoglycemic effects of UD tea bags in patients with T2DM on     glycemic control, insulin sensitivity, along with its effects on lipid profile (LP), blood     pressure (BP), liver, and kidney function.   "
197226|NCT00422370|"     Over 10% of adult population suffers from dry mouth (xerostomia). The aim of this double     blind prospective clinical trial is to examine a new lipid based food additive formulation to     ease mouth dryness in these patients.   "
197227|NCT00422383|"     This study will evaluate the efficacy and safety of various treatment and retreatment     regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly     either orally or parenterally. The anticipated time on study treatment is 2+ years, and the     target sample size is 100-500 individuals.   "
197228|NCT00422396|"     This is a randomized placebo controlled clinical trial designed to investigate the effects of     micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and     lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic     individuals with two or more other characteristics of the metabolic syndrome.   "
197256|NCT00422760|"     Clinical Case report Of spontaneous esophageal perforation in a 75 year old man. He prsented     with breathlessness and on investigation found to have esophageal perforation   "
197257|NCT00422773|"     The purpose of this study is to assess a maximal tolerable dose and to assess the safety of a     chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-fluorouracil     (5-FU)/folinic acid (FA) as first-line treatment for metastatic colorectal cancer.   "
197229|NCT00422409|"     Obstruction of the digestive tract is a frequent cause of morbidity in patients with     gastrointestinal cancer.Palliative endoscopic treatment with self- expanding metal     stents(SEMS)is an alternative to palliative surgery and other palliative treatment     options.The method has expanded to include patients with malignancies in the     esophagus,gastroduodenal region, biliary tractus and colon. Numerous retrospective studies     have reported treatment with SEMS to be safe and effective. Prospective studies,and     especially studies regarding Quality of Life improvement are needed.      PURPOSE:      The purpose of this trial is to prospectively study the use and effect of selfexpanding metal     stents(SEMS)in a defined population i Norway, especially Quality of Life changes.   "
197230|NCT00422422|"     Initial study in children with epilepsy to evaluate the pharmacokinetics, safety,     tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to     develop dosing adaptations for future studies.   "
197231|NCT00422435|"     This study is designed to evaluate the performance and safety of a new catheter system.   "
197232|NCT00422448|"     This project is a multicenter study in which we will investigate a dual concept of     nevogenesis. Study location is the Department of Dermatology at the Medical University of     Graz in collaboration with centers in Austria (Vienna), Italy (Naples, Benevento, Modena),     Spain (Barcelona) and the United States (New York).      The hypothesis is that small congenital melanocytic nevi (CMN), early acquired melanocytic     nevi in childhood (AMN) and dermal nevi, all dermatoscopically characterized by globular     pattern, belong to the same spectrum of genetically determined melanocytic proliferations     that develop due to endogenous pathways, in contrast to true acquired melanocytic nevi,     dermatoscopically showing reticular pattern, that develop due to exogeneous factors such as     UV-exposure.   "
197233|NCT00422461|"     The purpose of this study is to evaluate the safety and blood pressure lowering effect of     different doses of PF-00489791 in patients with mild to moderate high blood pressure   "
197234|NCT00422474|"     After acute stroke, baroreflex sensitivity (BRS) is impaired. This impaired acute stage BRS     has been reported to be predictive of worsen outcome years after stroke in general. However,     it is not very clear if the impaired acute stroke BRS would actually persist months after the     acute stage. It is also not clear that such change, if any, would correlate with the     functional outcome or prognosis after stroke.      The trial is to investigate the longitudinal time course of BRS after ischemic stroke up to     the 6th month post stroke and to see if there is any correlation of the changes in BRS with     the functional outcome parameters using NIHSS and mRS scores throughout this period.   "
197235|NCT00422487|"     The purpose of this study is to collect important information regarding the glucose-lowering     efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in     diabetics. It will also provide important information about the appropriate doses to be used     in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and     in combination with other anti-diabetic agents.   "
197236|NCT00422500|"     Primary Objectives:        -  To compare the severity of symptoms, their impact on affective and health-related          functional status, and symptom interference among patients with advanced-stage lung          cancer following initiation of chemotherapy by disease status, tumor response to          chemotherapy, and adequacy of symptom management.        -  To examine the relationship of disease-related and treatment-related physical symptoms          to affective impairment and the patient's reported symptom interference and functional          impairment.        -  To compare symptom severity, adequacy of symptom management, and interference with          affective status and health-related function by patient's minority status.        -  To explore the serum level of inflammatory cytokines during chemotherapy among lung          cancer patients.        -  To measure DNA repair capacity (DRC) in lymphocyte cultures of all patients enrolled in          the protocol at baseline (before treatment) and during each follow-up blood draw. The          hypothesis is that patients with suboptimal DRC will do better with chemotherapy than          patients with efficient DRC.        -  To extract DNA and genotype for polymorphisms in genes involved in the nucleotide          excision repair pathway and in those involved in response to pain (opioid receptors,          dopamine receptors, COMT). We hypothesize that:             1. Polymorphisms in NER genes that modulate DNA repair capacity will also effect               response to chemotherapy and to outcome.             2. Cytokine gene polymorphisms account for variations in symptom outcomes (specific               symptoms and symptom clusters) before, during and after chemotherapy.             3. The COMT val/met polymorphism affects the metabolism of catecholamines on the               modulation of response to sustained pain.             4. Dopamine receptor polymorphisms that result in decreased density of dopamine               receptors will result in a deficit in the dopamine pathway. that will also affect               response to pain.        -  To evaluate neurocognitive function to determine the prevalence, severity, and pattern          of cognitive symptoms.   "
197237|NCT00422513|"     This 2 arm study will compare 'time and motion' (provider time spent on anemia management)     and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera)     and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis.     Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive     standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360     micrograms (iv), monthly. After a titration period, average time spent on anemia treatment     over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12     months, and the target sample size is 100-500 individuals.   "
197238|NCT00422526|"     The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on     the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with     a short cervical length of 15mm.   "
197239|NCT00422539|"     This study aims to determine the efficacy of 70% trichloroacetic acid on atrophic scars of     varicella   "
197240|NCT00422552|"     The purpose of this study is to assess the change in inspiratory capacity and lung function     in patients with chronic obstructive pulmonary disease when treated with indacaterol compared     to placebo and formoterol.   "
197241|NCT00422565|"     The trial has the following primary objective:      To compare the safety and effectiveness of primary acute MI intervention with ABT 578-eluting     balloon expandable stent (Medtronic, Minneapolis, MN) vs. sirolimus-eluting balloon     expandable stent (Cordis Johnson & Johnson, Warren, New Jersey) vs. paclitaxel-eluting stent     (Taxus Liberte, Boston Scientific).   "
197242|NCT00422578|"     Study is a clinical study assessing the effect of oral tadalafil 10mg or 20 mg on     psychosocial aspects and quality of life of erectile dysfunction patients and to compare     tadalafil with previous oral erectile dysfunction medication. Study period is 13 weeks. Study     patients fill in quality of life questionnaires and treatment satisfaction questionnaires.   "
197243|NCT00422591|"     The goal of this clinical research study is to find out if standard chemotherapy given with     idarubicin and Cytarabine (ara-C) can help to control AML.      Objectives:      To determine the complete response (CR) rate, event-free survival (EFS) and overall survival     (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard     combination chemotherapy with Idarubicin and cytarabine.   "
197246|NCT00422630|"     Current estimates suggest that 65% of American adults are overweight or obese. Excess body     weight has been associated with an increased risk of a number of metabolic abnormalities,     including high blood sugar, high blood pressure, high triglyceride levels, and low HDL     (good) cholesterol levels. Insulin resistance (when the body becomes less sensitive to the     blood sugar-lowering hormone insulin, and more of the hormone is needed to keep blood sugar     levels under control) also frequently occurs as a result of excess body weight. These     abnormalities can all increase the risk of heart disease and other serious medical problems.     Individuals who are overweight often have a number of these abnormalities at the same time, a     situation which is often called the metabolic syndrome. Dietary changes, physical activity,     and weight loss can lead to improvements in each of the metabolic abnormalities described     above. However, the best type of diet for people with the metabolic syndrome is not known.     This study has been designed to test the effects of several promising dietary patterns, with     and without weight loss, in overweight adults with the metabolic syndrome. Most individuals     who have the metabolic syndrome do not know they have the condition, so we will be screening     many healthy overweight volunteers to see if they may be eligible.   "
197247|NCT00422643|"     Osteoarthritis is the most common disease effecting human beings with incidence of about 20%     and prevalence close to 80% of the adult population. It is most common after the age of 60     years and more in females with the ratio 4:1 F:M. Osteoarthritis Can be present in every     hyaline joint, but is mostly damaging to the weight bearing joints, the knees and hips. At     the final stage of cartilage destruction (from wear and tear) joint replacement is the     solution. Since these operations were introduced about 50 years ago, the indications and the     number of yearly procedures has been increasing with alarming speed. Last year in the united     states, about 500,000 Total Knee procedures were done, exceeding Total Hip replacements.      By 2030, close to 4.5 million joint replacement procedures are expected in the United States,     the majority of which will be knee replacements. Joint replacement is the solution for the     final stage of damaged cartilage. In early and advanced stages of cartilage wear and     specifically in the knee H.A. acts as an anti inflammatory and lubricant agent, reducing the     knee pain and improving knee motion and function.      The biological effect of H.A. is well documented in clinical studies and less with scientific     evidence derived from patients themselves.      Our study proposal briefly is, as follows:      60 patients with evidence of osteoarthritis of the knees will join the study after I.R.B.     (Helsinki Committee) approval. All of them will be examined, x-rays will be performed and     blood tests will exclude patients with infections or inflammatory disease. A V.A.S. (Visual     Analog Score) and SF-36 evaluation form will be completed prior to each intraarticular     injection, in addition to a complete medical examination. The enrolled patients will receive     the usual three intraarticular knee injections of H.A.(Arthrease), but prior to each     injection, the joint will be aspirated and the joint fluid will be analyzed for Chondroitin     sulfate type I and type II as described further in this project.      Three and six months after the third initial injections, the patients will recalled and joint     fluid will be aspirated again, followed by an H.A. injections, if symptomatic.      This study is the only one ever proposed, for evaluating joint debris qualitatively and     quantitatively. It will provide clinical information as well as objective data on the     preservation of the joint cartilage. Hopefully, this study will provide additional     information such as the relationship between the presence of debris and symptomatic vs.     asymptomatic patients. It may help in determining how long the injected H.A. has an effect     and whether serial and periodical injections are indicated.      Inclusion criteria:      1. patients with the diagnosis of Osteoarhtritis of the knee, graded according to Kellgren as     grade 1-4      Exclusion criteria:        1. Patients that suffer from acute septic arthritis.        2. Patients that treated with coumadin and/or other anti-coagulant drugs        3. Patients that show mental or physical conditions, which preclude compliance with study          and/or device.   "
197248|NCT00422656|"     The purpose of this research study is to assess the response rate of perifosine in patients     with relapsed or refractory Waldenstrom's macroglobulinemia. Perifosine is a newly discovered     compound that kills Waldenstrom cells in laboratory experiments. Perifosine has been used in     research for the treatment of other types of cancer such as multiple myeloma.   "
197249|NCT00422669|"     The purpose of the Optimize RV study is to determine the long-term effect of selective site     pacing. Selective site pacing refers to which area of the right ventricle the lead is placed.     The goal of select site pacing is to improve how the heart contracts when paced in the     ventricle. By pacing in select sites, it is possible to better copy the natural pattern of     contraction of the heart.   "
197250|NCT00422682|"     The purpose of the study is to assess the safety and establish the maximum tolerated dose     (MTD) of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with     histologically or cytologically documented advanced solid tumors.      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
197251|NCT00422695|"     There are about 42 million people in the world afflicted with HIV or AIDS with about 1     million patients in the US.      The epidemiology of orofacial pain has been reported extensively in the literature, yet the     prevalence severity and level of pain affecting the head, face, neck and intraoral structures     has not been explored in a population of HIV infected individuals.      Pain, in general terms, is a common experience in HIV infected patients, even in the absence     of cancer or opportunistic infections. There is a variation in the prevalence of pain in     these individuals depending on the stage of disease, care setting, and study methods. The     purpose of this study is:        1. To investigate the prevalence of orofacial pain in HIV infected patients during routine          dental clinical assessment.        2. To study the sensory phenotype of HIV+ patients and healthy volunteers using          Quantitative Sensory Testing:             -  To detect the presence of sensory aberrations in the orofacial complex;             -  To identify which nerve types are involved;             -  To identify the type of orofacial pain based on both sensory testing and clinical               findings.        3. To determine psychological condition and nutrition status in patients with HIV.        4. To find associations between inherited traits and development of neuropathic pain.   "
197252|NCT00422708|"     Title: Local anesthesia for office biopsy of the prostate: effects on pain control, quality     of life and surgical intervention.      Introduction: Local anesthetic should be administered prior to transrectal needle biopsy of     the prostate to control pain in the office setting. Various centers have injected anesthetic     in different regions in and around the prostate prior to biopsy. Patient experience with each     technique has varied. We would like to determine which procedure provides the best pain     control. In addition, we would like to know if the anesthetic placement has any effect on     urinary patterns, bowel habits, and sexual function. Furthermore, for those patients found to     have cancer and elect surgical treatment, we plan to evaluate if the anesthetic had an impact     on surgical dissection of their prostate.      Methods: The investigators plan to identify those patients who require prostate biopsy for     diagnosis. Each patient will be randomly assigned to a different anesthetic injection group.     During the biopsy protocol, our nurse will monitor the patient?s pain level according to the     visual analog score. The patient will complete a pre-biopsy questionnaire and two post-biopsy     questionnaires administered at 1 and 4 weeks after biopsy. He will receive results of the     prostate biopsy pathology report within 48 hours by calling his primary referral service.   "
197253|NCT00422721|"     Retinal dystrophies are responsible for numerous cases of blindness, and there are no     therapeutic possibilities today. Gene therapy is efficient in a dog model concerning     dystrophy linked to a mutation of the rpe65 gene. If such a therapy is to be considered for     humans, it is urgent to select, at a national level, patients suffering from dystrophy linked     to a mutation of the rpe65 gene. The systematic correlation of phenotype/genotype is an     anatomical-functional approach, but it also identifies patients who may be potentially     included in a future gene therapy study. Indeed, identification of people with a mutation of     rpe65 is still insufficient in France (compared to other European countries) because of a     lack of systemic genotyping of retinal dystrophy.   "
197254|NCT00422734|"     To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves     getting and maintaining an erection in men with erectile dysfunction and if there are     improvements in the sexual quality of life of the man and his female study partner   "
197255|NCT00422747|"     The overall aim of the study is an early asthma diagnosis in young children by the use of     non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early     lung function measurements   "
197259|NCT00422799|"     In this study, we are trying to find out if the combination of these two drugs is effective     in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not     been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and     Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a     cancer that is closely related to Waldenstrom's macroglobulinemia.   "
197260|NCT00422812|"     Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine     headaches. In October 2005, we completed a 75 patient, multi-center, double-blind     placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe     acute migraine headaches. This Phase 2B clinical trial of Staccato Prochlorperazine has been     initiated to assess the efficacy and safety in outpatients with migraine headache with or     without aura.   "
197261|NCT00422825|"     This is a single center, four-treatment, four period, crossover study to evaluate the effect     of food on the relative bioavailability of a single dose of imatinib (STI571) given as a 800     mg modified release tablet, MR2 compared to twice-daily doses of 400 mg film-coated imatinib     tablets. There will be a 10 day wash out phase between treatments and a 1 week safety period     at the end of the study. Each participant will receive all four treatments   "
197262|NCT00422838|"     Aim      To evaluate the effects of peginterferon and ribavirin therapy on the immune response in     chronic HCV genotype 1,2 or 3 patients before, during and after treatment.      Background      Treatment of chronic hepatitis C (HCV) has shown a remarkable success. However, genotype 1     patients have reduced response rates. A better understanding and improvement of these results     can now be considered the greatest challenge.      In chronically infected patients, HCV-specific immune responses are generally weak, narrowly     focused, and often dysfunctional. The presence of HCV-specific cells suppressing the immune     response (regulatory T-lymphocytes=Treg) are able to suppress the immune response. These Treg     are possibly responsible for the impaired immune response.      Previous studies have indicated increased Treg frequency and activity of immune regulating     mechanisms, locally in the liver, as a result of HCV re-infection. Hence, these Data     highlight the importance of monitoring intrahepatic immune responses in addition to     peripheral immune responses. Using the minimally-invasive technique of fine-needle aspiration     biopsy (FNAB), it is now possible to obtain safe and frequent liver samples to monitor local     antiviral immune responses in chronic HCV patients during antiviral therapy.      Rationale and hypothesis of the study      Our previous studies and current literature support the concept that Treg may contribute to     HCV persistence by suppressing HCV-spec immune responses. The current study is designed to     examine if peginterferon and ribavirin therapy affects the activity of Treg and DC, and if     this results in enhanced HCV-specific immune responses.      Design      Single centre, translational and observational open label study with one arm of 20 genotype 1     patients and one arm of 7 genotype 2/3 patients.   "
197263|NCT00422851|"     This study will determine if gas can pass between the environment and the middle ear by way     of the eardrum. This route of gas exchange was observed in animals but has not been studied     in humans. If gas exchange across the eardrum is documented and the rate is sufficiently     high, this can help explain certain past observations such as why middle ear pressure does     not change very much in some children and adults when they have a cold or flu. The     investigators also expect that the rate of gas exchange across the eardrum will depend on     whether or not the eardrum has scarred or abnormally thin regions.   "
197264|NCT00422864|"     This trial is a single-arm study for patients presenting with both local and metastatic     adenocarcinoma of rectum. The aims of the trial are (1) to determine the tolerability rate,     and (2) to determine toxicity rates, pelvic and distant response rates in patients with     locally advanced rectal cancer in the presence of distant metastasis who are treated with an     interdigitating chemotherapy (oxaliplatin/5-fluorouracil [5FU]) and radiotherapy regimen.   "
197265|NCT00422877|"     To evaluate objective response rate and duration of response to weekly Taxoprexin®.      To evaluate the safety profile of weekly Taxoprexin® in this patient population.      To evaluate overall survival in the same patient population.      To evaluate time to disease progression, and the time to treatment failure in patients with     primary liver cancer being treated with weekly Taxoprexin® Injection.      To explore the trough and peak blood levels of Taxoprexin® and paclitaxel in these patients.   "
197266|NCT00422890|"     Efficacy and safety of 5-Azacytidin in the treatment of the haematological relapse in     patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling     CD34-chimerism after hematopoietic stem cell transplantation.   "
197267|NCT00422903|"     Evaluate the percentage of clinical objective responses (cOR) in patients with HER2 negative     early breast cancer treated with pre operative (neoadjuvant)lapatinib and letrozole   "
197268|NCT00422916|"     The intervention program Obeldicks light is developed for overweight children aged 8-16     years. This intervention is gender - and age specific.      The 6-month intervention is based on nutrition course, behaviour therapy and exercise     therapy. The evaluation compromised quality of structure, process and results of the     intervention. 300 participants in a randomised controlled group design will be evaluated at 4     time points: baseline, end of intervention, 6 months after end of intervention and 12 months     after end of intervention.Primary outcome measure is change of weight status as standard     deviation score of BMI. Drop-outs will be interviewed to improve the intervention.   "
197269|NCT00422929|"     This study is to measure over time (from 3 years until 13 years of age) Eustachian tube     function (the way the Eustachian tube works) and facial growth in groups of children with two     types of middle-ear disease and with little past middle-ear disease. These measures will be     used to determine if facial growth is related to improved Eustachian tube function, to see if     the better function explains why young children who have middle-ear disease outgrow it as     they get older, and to determine if these measures are different for the children in the     three groups defined by disease history.   "
197270|NCT00422942|"     This single arm study will investigate the pattern of B cell depletion in synovial tissue and     peripheral blood of patients with active RA, after MabThera (1000mg iv x 2 on days 1 and 15)     + methotrexate (10-25mg/week po) treatment. The clinical efficacy and pharmacokinetic profile     of MabThera after treatment and retreatment will also be investigated. The anticipated time     on study treatment is 2+ years, and the target sample size is <100 individuals.   "
197271|NCT00422955|"     Fluid management study in patients with type 2 diabetes and autonomic neuropathy.   "
197272|NCT00422968|"     The primary objective of the PRE-COMBAT trial is:      To establish the safety and effectiveness of coronary stenting with the sirolimus-eluting     balloon expandable stent (Cordis Johnson & Johnson, Warren, New Jersey) compared with bypass     surgery for the treatment of an unprotected LMCA stenosis. The alternative hypothesis is that     the experimental strategy (coronary stenting with the sirolimus-eluting stents) is not     inferior to the standard strategy (bypass surgery).   "
197273|NCT00422981|"     The purpose of this study is to find out if different doses of Investigational Drug are safe,     tolerable, and if they have an effect on Mild Cognitive Impairment (MCI).   "
197274|NCT00422994|"     This study will investigate the effects of severe renal impairment and hemodialysis on the     characteristics of the drug, ropinirole.   "
197275|NCT00423007|"     The primary objective of this study is to investigate the efficacy and safety of bromfenac     ophthalmic solution for treatment in subjects with a history of allergic conjunctivitis   "
197276|NCT00423020|"     The EPOC-AMI study is to assess the safety and the efficacy of systemic administration of     erythropoietin for inhibition of neointimal hyperplasia after stent implantation in the     patients with acute myocardial infarction   "
197277|NCT00423033|"     The aim of this search is to realize the subjective experiences of employment among     schizophrenic patients by qualitative analysis. We plan to recruit 50 people diagnosed with     schizophrenia and divide into two groups, employment and unemployment. Every subjects will     complete the demographic data, the evaluation of severity of disease, the record of     medication and an intensive interview about their employment experiences. Finally, we will     analysis the thick descriptions to understand how schizophrenic patients interpret their     employment experiences and which factors will affect their successful employment.   "
197278|NCT00423046|"     HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals     has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) which targets the 2 most common     oncogenic HPV types (HPV-16 and HPV-18), found in > 70%, approximately, of all cervical     cancers. Recently, Merck's HPV vaccine Gardasil® [quadrivalent human papillomavirus     (HPV-6,11,16,18 L1 VLP) recombinant vaccine] has been approved by the FDA for prevention of     genital tract cancers and pre-cancers and genital warts in females. Although the GSK HPV     vaccine and Gardasil® have different compositions and are expected to have different efficacy     profiles, each vaccine targets prevention of HPV-16 and 18 genital tract cancers and     pre-cancers. Therefore, a comparison of the immunogenicity of the two vaccines is warranted.     This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine (HPV-16/18)     to Gardasil® in healthy adult females 18-45 years of age.      The Protocol Posting has been updated as the study will be extended by 3 additional years.   "
197279|NCT00423059|"     Recently, intravitreal bevacizumab (Avastin) injection has gained popularity as a potential     treatment of intraocular neovascularization (CNV) associated with age related macular     degeneration and diabetic retinopathy. The efficacy of the drug is thought to be related with     its pharmacologic blockade of VEGF.      The purpose of this study is to determine the effect of the intravitreal bevacizumab on the     fibrovascular membrane associated with proliferative diabetic retinopathy by objective     histologic evaluation.      The patients scheduled for vitrectomy for tractional fibrovascular membrane due to     proliferative diabetic retinopathy will be randomized into two treatment groups. The one will     receive conventional vitrectomy and the other group will receive intravitreal bevacizumab     injection one week before the scheduled vitrectomy. The fibrovascular membrane will be     excised during surgery and fixated for histologic examinations. The expression of VEGF and     PEDF, a potent inhibitor of angiogenesis, will be evaluated in the fibrovascular membrane by     immunohistochemistry. The results will be compared between two treatment groups.   "
197280|NCT00423072|"     The investigators know that middle-ear disease is very common in infants with cleft palate     and causes hearing loss that can last into childhood. It is thought that a poor ability to     keep the pressure in the middle ear at a similar level to that in the environment causes     middle-ear disease and that this depends on the opening function of a natural tube that     connects the back of the nose with the middle ear, called the Eustachian tube. The     investigators believe that the middle-ear disease in cleft palate infants and children is     caused by poor Eustachian tube function that in turn is caused by anatomical problems in the     muscles that open the tube. The investigators plan to test these relationships by studying     the changes between 5-24 months and 6 years in middle-ear health, the way the Eustachian tube     works and Eustachian tube anatomy in cleft palate children.   "
197281|NCT00423085|"     The purpose of this study was to investigate the 5cm^2 and 10cm^2 doses of rivastigmine     transdermal patch in terms of efficacy and safety in patients with probable Alzheimer's     Disease (MMSE [Mini Mental State Examination] 10-20). A 52-week extension phase evaluated the     safety and tolerability of long-term treatment by rivastigmine transdermal patch in patients     with probable Alzheimer's Disease (AD).   "
197282|NCT00423098|"     The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in     combination with two different corticosteroid (CS) regimes for the induction of remission of     a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I)     or to a reduced dose CS regimen (group II)   "
197283|NCT00423111|"     The purpose of this study is to determine whether there is a correlation between cognitive     functions and volume of specific brain area measured in MRI of multiple sclerosis patients.   "
197284|NCT00423124|"     The aim of the study is to obtain immune reconsitutuion as well as reduction of infective     episodes and disease relapse in patient with haematological malignancies who underwent     SCT(and subsequent T lymphocytes infusions) and selectively controlling GvHD.   "
197285|NCT00423137|"     Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis   "
197286|NCT00423150|"     This study is proposed to evaluate the efficacy and safety of temozolomide, an oral     anti-cancer agent, in a participant population selected for a biomarker. Participants with     colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer     will be included.   "
197287|NCT00423163|"     To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole     alone as primary therapy for invasive aspergillosis.   "
199438|NCT00450905|"     This study is being performed to determine the safety and efficacy of Fralex Neuromodulation     Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal     pain associated with Fibromyalgia.   "
197288|NCT00423176|"     The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone     furoate nasal spray), when used together with an antibiotic, for the relief of symptoms     associated with acute bacterial sinusitis. Efficacy will be based on both subjective     (assessment of symptom severity by the patient) and objective measurements (computed     tomography [CT] imaging of the sinuses).   "
197289|NCT00423189|"     The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination     therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with     exudative AMD.   "
197290|NCT00423202|"     A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy     of ambrisentan in subjects with pulmonary arterial hypertension.   "
197291|NCT00423215|"     The objective of this protocol is to confirm the efficacy and safety profile of Lantus in     every day medical practice, in type 2 diabetic patients, have been treated with any other     insulin but who did not reach the target of A1c = 7%.   "
197292|NCT00423228|"     Alzheimer's disease is characterised by memory loss and difficulties with thinking. These     problems may be due to a deficiency in a brain chemical called acetylcholine. Acetylcholine     helps transmit messages between nerve cells. Acetylcholine is degraded by an enzyme called     acetylcholinesterase. ZT-1 is a new drug derived from a plant extract already used in China     for memory disorders, which blocks the action of the enzyme and restores adequate levels of     acetylcholine.      This study will test the safety and efficacy of ZT-1 in the treatment of patients with     Alzheimer's disease.      BRAINz stands for Better Recollection for Alzheimer's patients with the Implant of ZT-1.   "
197293|NCT00423241|"     This study will compare the clinical performance of the SEMPERFLO* Pain Management System     with another commercial pain relief system using 0.5% bupivacaine following unilateral, open,     inguinal hernia repair procedures.      *Trademark   "
197294|NCT00423254|"     The present clinical trial is a dose comparison of a multi-component active immunotherapy     designed to stimulate an immune reaction to specific tumor associated antigens which are     highly expressed on a large number of solid cancers.   "
197295|NCT00423267|"     To evaluate the safety of posaconazole (POS) in the treatment of coccidioidomycosis. Period A     consisted of 2 blinded arms, posaconazole and fluconazole. Recruitment was stopped, and     participants in Period A may have been eligible to roll over to an open-label,     non-comparitive Period B. During Period B, participants received posaconazole for a treatment     duration not to exceed 12 months.   "
197296|NCT00423280|"     The purpose of this study is to determine the effect of 6R-BH4 on vascular function in     patients with coronary artery disease. We hypothesize that 6R-BH4 will improve vascular     function in these patients.   "
197297|NCT00423293|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in     chemotherapy, such as fluorouracil and mitomycin C, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     radiation therapy together with 5-fluorouracil (5-FU) and mitomycin C may kill more tumor     cells.      PURPOSE: This phase II trial is studying the side effects and how well giving     intensity-modulated radiation therapy together with fluorouracil and mitomycin C works in     treating patients with invasive anal cancer.   "
197298|NCT00423306|"     The study of safety of a new organic arsenic compound in the treatment of advanced     hepatocellular carcinoma   "
197299|NCT00423319|"     The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg     (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip     replacement surgery and to learn how apixaban compares with enoxaparin in preventing these     clots. The safety of apixaban will also be studied   "
197300|NCT00423332|"     Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours     and also how well it is tolerated.   "
197301|NCT00423345|"     Registration of patients referred for colon investigation by barium enema, CT colonography     and colonoscopy in two hospitals and one radiology centre in Telemark, Norway, for a period     of minimum six months. Indications, delay and results of procedure will be     recorded.Hypothesis: Choice of procedure for colon investigation is not based solely on     clinical indication, but factors like delay, patient preference, lack of knowledge about the     the procedures by the referring physician may have a decisive influence. The study will also     analyse the correlation between patients symptoms, clinical findings and laboratory results     and major pathology findings by colon investigation. Further, delay from patient´s first     symptoms to finally diagnosis by colon investigation will also be registered and analysed.   "
197302|NCT00423358|"     This study recruits individuals with rheumatoid arthritis (RA) and low vitamin D     concentrations. Subjects are dosed with vitamin D or placebo for one year. Primary outcome is     change in bone turnover markers, additionally, bone mineral density and parameters of RA     status are evaluated throughout the study.   "
197303|NCT00423371|"     This multicenter, double-blind, randomized, parallel-group, active-controlled trial will be     performed in approximately 80 subjects with chronic idiopathic osteoarthritis (OA) of the     first carpo-metacarpal joint (CMC).   "
197304|NCT00423384|"     Loss of bone mass is a common complication in patients with end-stage-renal failure, both     before and particularly after transplantation. In addition to standard underlying therapy     with calcium and active vitamin D, we will study the effect of ibandronate (a bisphosphonate)     versus placebo on bone mineral density as well as incidence of fracture rates after kidney     transplantation.We also wish to study whether any prevented bone loss will also lead to     reduced cardiovascular disease. Patients will be followed for 12 months after     transplantation, and the ibandronate treatment is one injection every 3 months.   "
197305|NCT00423397|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. PEG-interferon alfa-2a may interfere with the growth of tumor cells     and slow the growth of skin cancer. Giving gefitinib together with PEG-interferon alfa-2a may     kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of PEG-interferon     alfa-2a when given together with gefitinib and to see how well they work in treating patients     with unresectable or metastatic skin cancer.   "
199451|NCT00451074|"     The purpose of this study is to determine the safety of giving intravenous (IV) gentamicin to     boys with Duchenne muscular dystrophy who have stop codon mutations.   "
197307|NCT00423436|"     Primary Objectives:        -  To compare the effectiveness of an interactive voice response (IVR) telephone          triage/feedback system versus an interactive voice response telephone system with          assessment only in monitoring and managing symptoms in patients with advanced non small          cell lung cancer (NSCLC).        -  To compare differences in mood and quality of life variables of patients using the IVR          triage/feedback system versus IVR assessment only.        -  To compare the healthcare utilization (emergency visits, admissions, length of stay for          hospitalizations for uncontrolled symptoms) of patients using the IVR triage/feedback          system versus IVR assessment only.   "
197308|NCT00423449|"     This is a clinical trial to determine the safety and tolerability of MK0683 in combination     with gemcitabine and cisplatin and/or carboplatin.   "
197309|NCT00423462|"     Analysis of the ongoing patient-therapist interaction, the transference, is considered a key     active ingredient in psychoanalytically oriented psychotherapy and psychoanalysis.However,     one century after Sigmund Freuds's famous Dora case, the first clinical description of     transference, no study of transference interpretations have been published.In the present     study 100 out-patients were randomized to receive one year weekly dynamic psychotherapy, with     and without transference interpretations. That is, one treatment component,transference     interpretations, were added to a comparison condition, therapy of the same format, by the     same therapists, but without use of transference interpretation.      All treatment session were audiotaped, and treatment integrity have been carefully checked.     Patients were evaluated at treatment termination, one year after treatment termination and     three years after treatment termination. Enrollment of patients started january 1993, and all     follow-up evaluations completed by December 2005.   "
197310|NCT00423475|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause     the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the     adrenal glands from making androgens. Giving radiation therapy with or without goserelin     after surgery may kill any tumor cells that remain after surgery. It is not yet known whether     radiation therapy is more effective with or without goserelin in treating prostate cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see     how well they work compared with radiation therapy alone in treating patients who have     undergone surgery for recurrent or refractory prostate cancer.   "
197355|NCT00424060|"     RATIONALE: Drugs used in chemotherapy, such as epothilone ZK-219477, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing.      PURPOSE: This phase II trial is studying how well epothilone ZK-219477 works in treating     patients with recurrent glioblastoma.   "
197311|NCT00423488|"     This multicenter, randomized, double-blind, placebo-controlled study will assess, after 6     weeks of dosing, whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be     more effective than treatment with doubling the dose of simvastatin to 40 mg alone in     reducing low-density lipoprotein-cholesterol (LDL-C) concentrations and in achieving the     National Cholesterol Expert Panel (NCEP) III LDL-C target goal of <2.6 mmol/L (<100 mg/dL)     for subjects with diabetes mellitus and coronary heart disease.   "
197312|NCT00423501|"     This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of     multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are     treated with a stable dose of metformin. Patients will be randomized to receive either     subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or     20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen     throughout the study. The anticipated time on study treatment is <3 months, and the target     sample size is 100-500 individuals.   "
197313|NCT00423514|"     RATIONALE: Giving chemotherapy, such as clofarabine, melphalan, and thiotepa, before a donor     stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop     the patient's immune system from rejecting the donor's stem cells. When the healthy stem     cells from a donor are infused into the patient they may help the patient's bone marrow make     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     tacrolimus and mycophenolate mofetil before the transplant may stop this from happening.      PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when     given together with melphalan and thiotepa, followed by a donor stem cell transplant and to     see how well it works in treating patients with high-risk and/or advanced hematologic cancer     or other disease.   "
197314|NCT00423527|"     Multiple sclerosis is often associated with pain. There is no standard treatment of this type     of pain. Levetiracetam is a new anticonvulsant and it is the hypothesis that it could relieve     central pain in multiple sclerosis. This is a randomised, double-blind, placebo-controlled,     cross-over trial on the effect of levetiracetam 3000 mg daily on pain in multiple sclerosis.   "
197315|NCT00423540|"     This study sets out to show whether infusions of magnesium can lessen the frequency of rest     cramps and to determine whether rest cramp sufferers have a deficiency in magnesium.   "
197316|NCT00423553|"     This study will collect heart tissue that is routinely removed and discarded during     open-heart surgery. The Cardiology Branch of the NHLBI is conducting a variety of laboratory     experiments that require a sample of heart tissue. A segment of tissue is routinely cut out     of the right atrial appendage of the heart during open-heart surgery to allow the heart-lung     bypass machine to be attached to the heart for protection during surgery. This small tissue     sample is not re-attached after the bypass machine is removed, but usually destroyed as     medical waste.'      People between 18 and 80 years of age who are scheduled to undergo coronary artery bypass     surgery or aortic valve replacement surgery may be eligible for this study.      Participants donate the right atrial appendage of the heart, which would normally be     destroyed after their open-heart surgery. The tissue will be used by NHLBI investigators in     studies directed at learning how to make the heart less sensitive to damage from a heart     attack. The samples may be used, for example, to evaluate the effectiveness of known     therapies, refine treatment approaches, identify potential new therapies, or explore     opportunities for disease prevention.   "
197317|NCT00423566|"     This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia     Ankara (MVA) expressing the 85A antigen (from Mycobacterium. tuberculosis). This vaccine is     delivered intrdermally by a needle injection in healthy volunteers.   "
197318|NCT00423579|"     This study is being conducted to compare the efficacy, safety, and tolerability of     ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of     simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.   "
197319|NCT00423592|"     This Phase 2 study was to determine the incidence of increased serum aminotransferase     concentrations (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]), as     well as the overall safety and tolerability of ambrisentan, in participants with pulmonary     arterial hypertension (PAH), idiopathic PAH (IPAH), or familial PAH (FPAH) who had previously     discontinued ERA therapy (bosentan or sitaxsentan) due to increased serum ALT or AST     concentrations.   "
197320|NCT00423605|"     The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term     use.   "
197321|NCT00423618|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known     whether giving radiation therapy to a smaller area of tissue surrounding the tumor is as     effective as giving radiation therapy to a wider area of tissue surrounding the tumor in     treating soft tissue sarcoma.      PURPOSE: This randomized phase III trial is studying giving external-beam radiation therapy     to a small area of tissue surrounding the tumor to see how well it works compared with giving     external-beam radiation therapy to a wider area of tissue surrounding the tumor in treating     patients who have undergone surgery for soft tissue sarcoma of the arms, hands, legs, or     feet.   "
197322|NCT00423631|"     Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered     a chronic condition and is most commonly treated or managed using medications. Previous     studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication     intervention, to standard care in order to obtain better outcomes in terms of improved     functional status and symptom reduction. While the addition of CBT to standard care has been     shown to be beneficial, it is not a form of therapy that is widely available to patients with     FMS. CBT includes a variety of skills that can be taught to patients to help in the     management of chronic illnesses. This protocol will examine the relative merits of providing     these CBT skills to patients via an informational website. The website will contain the     content of CBT, a social support capability, and data transfer capabilities. The addition of     this website to standard care will be compared to standard care alone. This study is     interested in assessing improvements in physical functional status, the symptoms of FMS, and     the relative costs of the interventions as compared to the savings in health care utilization     over a 6-month period.      Primary Hypothesis The primary hypothesis of this study is that the number of patients with     fibromyalgia who are able to achieve clinically meaningful improvements in physical function     will be greater when standard symptom-based pharmacological care is augmented by CBT skills     delivered through an educational website.      Secondary Hypotheses        1. The proportion of patients with fibromyalgia who are able to achieve clinically          meaningful improvements in symptoms of FMS such as pain, fatigue, and perceived          cognitive difficulties will be greater when standard symptom-based pharmacological care          is augmented by CBT skills delivered through an educational website        2. The proportion of patients with fibromyalgia who are able to achieve clinically          meaningful improvements in mood and beliefs about pain will be greater when standard          symptom-based pharmacological care is augmented by CBT skills delivered through an          educational website   "
197323|NCT00423644|"     The study of safety of a new organic arsenic compound in the treatment of advanced multiple     myeloma   "
197325|NCT00423670|"     This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve     Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2     parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly [QW]), plus ribavirin (800     to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034)     800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus     standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG)     and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000     mg/day) plus boceprevir for 48 weeks.   "
197326|NCT00423683|"     The development of clots is a potentially deadly complication in many cancer patients. The     current optimal treatment is unknown. Evidence supporting the effectiveness of the use of     Inferior Vena Caval Filters is lacking. This study will compare the two standard of care     treatment options: anticoagulation with or without a inferior vena cava filter. The     anticoagulation medication chosen will be Arixtra and it will be given once a day as an     injection. Patients will be called at various intervals to monitor their signs and symptoms     of new thromboembolisms.   "
197327|NCT00423696|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving bevacizumab together with combination chemotherapy may     kill more tumor cells. It is not yet known which combination chemotherapy regimen is more     effective when given together with bevacizumab in treating patients with colorectal cancer.      PURPOSE: This randomized phase II trial is studying bevacizumab to compare how well it works     when given together with two different combination chemotherapy regimens as first-line     therapy in treating patients with metastatic colorectal cancer that cannot be removed by     surgery.   "
197328|NCT00423709|"     1. To determine the feasibility and toxicity of employing allogeneic peripheral blood stem          cell transplantation after intensive but non-myeloablative chemotherapy in patients with          relapsed Hodgkin's disease (HD).        2. To determine the engraftment kinetics and degree of chimerism that can be achieved with          this strategy.        3. To assess the antitumor activity of this approach in high-risk HD patients and the          possible presence of a graft-vs-HD effect.   "
197329|NCT00423722|"     The goal of this clinical research study is to learn whether being hydrated (given liquids)     through a catheter in a vein or in the tissue under the skin can improve symptoms of     dehydration.      Objectives:      1.1 Determine whether parenteral hydration is superior to placebo in improving symptoms     associated with dehydration (such as fatigue, myoclonus, sedation, and hallucinations) in     advanced cancer patients receiving hospice care.      1.2 Determine whether parenteral hydration is superior to placebo in delaying the onset or     reducing the severity of delirium in patients with advanced cancer receiving hospice care.      1.3 Describe the meaning patients and primary caregivers attribute to dehydration and     re-hydration at the end of patient's lives.   "
197330|NCT00423735|"     This phase II trial studies how well dasatinib works in treating patients with glioblastoma     multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
197331|NCT00423748|"     A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy     of ambrisentan in subjects with pulmonary arterial hypertension.   "
197332|NCT00423761|"     This study will evaluate any effect of single and repeated administration of GW876008 on the     metabolism of midazolam in healthy volunteers.   "
197333|NCT00423774|"     his study will evaluate a series of problem-solving education sessions for patients     undergoing a stem cell transplant and their family caregivers. The emotional stress of     transplant extends beyond patients to their families, especially caregivers. Little is known     about managing the emotional distress associated with stem cell transplant or the support and     education most helpful to caregivers of stem cell recipients.      Patients undergoing a stem cell transplant and their family caregivers may be eligible for     this study. All participants must be 18 years of age and older.      Patients and their caregivers receive routine treatment-specific education from transplant     team members. This study adds a series of educational sessions focusing on problem-solving     skills. In addition to the study education, participants do the following:        -  Complete a 130-item questionnaire when they consent to participate in the study.        -  Complete a 60-item questionnaire and attend a 60-minute face-to-face education session          before the transplant.        -  Complete a 40-item questionnaire and attend a 60-minute face-to-face education session          before hospital discharge.        -  Complete the same 40-item questionnaire and attend a 60-minute face-to-face education          session 2 weeks after hospital discharge.        -  Attend a 30-minute face-to-face education session 4 weeks after hospital discharge.        -  Complete a 60-item questionnaire 6 weeks after hospital discharge.   "
197334|NCT00423787|"     Ragweed MATAMPL has been developed by Allergy Therapeutics to provide pre-seasonal specific     immunotherapy for patients with proven type I hypersensitivity to cross reacting ragweed     pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma     bronchiale. The purpose of this study is to compare the efficacy of Ragweed MATAMPL versus     placebo in ragweed-allergic subjects following 4 subcutaneous injections of study medication     administered before the start of the 2007 ragweed pollen season   "
197345|NCT00423930|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of head     and neck cancer by blocking blood flow to the tumor. Specialized radiation therapy that     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause     less damage to normal tissue. Giving cisplatin and bevacizumab together with     intensity-modulated radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving cisplatin and     bevacizumab together with intensity-modulated radiation therapy works in treating patients     with stage III or stage IV head and neck cancer.   "
197335|NCT00423800|"     This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48     weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve     Hepatitis C Virus (HCV) genotype 1 high viral load (HVL) participants who are Hepatitis C     Virus-Ribonucleic Acid (HCV-RNA) negative at Week 4. HVL will be defined as HCV-RNA of     >600,000 IU/mL prior to the initiation of therapy. Participants with genotype 1 baseline HVL     prescribed Pegetron® (peginterferon and ribavirin) in the usual manner in accordance with the     marketing authorization and who are viral negative at Week 4 will be randomized at Week 8 to     receive a total of 24 or 48 weeks of therapy. Participants will be required to have their     baseline and Week-12 viral load analyzed by the same local laboratory using the standard of     care test used by the site. Qualitative testing at Week 4, 8, 16-20, 24, and 48 may be     conducted either by local laboratory or a central laboratory identified by the sponsor using     an assay specified by the sponsor. No additional interventions outside of the clinic's     standard of care and the conditions of the Canadian product monograph for Pegetron® will be     applied to participants.   "
197336|NCT00423813|"     The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to     placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled,     parallel group trial.   "
197337|NCT00423826|"     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor     umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells.     It also stops the patient's immune system from rejecting the donor's stem cells. The donated     stem cells may replace the patient's immune cells and help destroy any remaining cancer or     abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can     also make an immune response against the body's normal cells. Giving tacrolimus and     mycophenolate mofetil before the transplant may stop this from happening.      PURPOSE: This clinical trial is studying how well umbilical cord blood stem cell transplant     works in treating patients with hematologic cancer or other disease.   "
197338|NCT00423839|"     A Phase I study of the Safety and immunogenicity of MVA85A in healthy Gambian volunteers   "
197339|NCT00423852|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. An autologous peripheral stem cell transplant may be able to replace     blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to     be given so that more tumor cells are killed.      PURPOSE: This phase I/II trial is studying the side effects and best dose of ifosfamide when     given together with paclitaxel and carboplatin followed by an autologous stem cell transplant     and to see how well they work in treating patients with germ cell tumors that did not respond     to cisplatin.   "
197340|NCT00423865|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Everolimus may also help cisplatin work better by making tumor cells more sensitive     to the drug. Giving cisplatin together with everolimus may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when     given together with cisplatin in treating patients with advanced solid tumors or recurrent or     metastatic solid tumors.   "
197341|NCT00423878|"     The study will compare the effectiveness of antipsychotic medications for patients with     schizophrenia or schizoaffective disorder for whom a medication change may be indicated     because of an increased risk of cardiovascular disease.   "
197342|NCT00423891|"     The purpose of this clinical study is to determine the appropriate doses of entecavir to use     in children and adolescents. Safety, tolerability and efficacy will also be studied   "
197349|NCT00423982|"     The number of patients requiring joint replacement is increasing due to its success in     restoring function and pain relief, and the growing population of the elderly. One of the     most serious complications of arthroplasty is joint prosthesis infection. Due to the absence     of prospective, randomized, controlled studies, there is no consensus concerning diagnosis     and treatment of prosthetic joint infections. The main objective of this trial is to evaluate     the clinical efficacy of rifampin combination therapy versus monotherapy using cloxacillin or     vancomycin in early staphylococcal infections after total hip and knee arthroplasty.   "
200225|NCT00471237|"     This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in     the treatment of osteoporosis in post-menopausal women, in comparison with 2 active     comparators and placebo.   "
197343|NCT00423904|"     The purpose of the study is to reveal the most promising procedure for implementing alcohol     screening and intervention in general hospitals and to find out, if and to which extent     non-specialist health professionals can be qualified to carry out motivational intervention     on their own or if there is a need for a specialized counseling services. In a randomized     controlled trial, patients recruited in general hospitals and fulfilling criteria for alcohol     dependence, alcohol abuse, at-risk drinking or heavy episodic drinking will be allocated to     three conditions: (1) Intervention by a liaison service (LC): Counselling based on the     Transtheoretical Model of behaviour change (TTM) which will be provided by staff of the study     (psychologists/ social worker) trained in Motivational Interviewing (MI), (2) Intervention by     hospital physicians (PC): Counselling will be provided by hospital physicians trained in MI,     and (3) Control group (CC): Treatment as usual, assessment only. Outcome assessment will be     conducted after 12 months and includes abstinent point prevalence rates, drinks per day,     help-seeking, stage progress and cost-effectiveness analysis.   "
197344|NCT00423917|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Fulvestrant and bevacizumab may also stop the     growth of breast cancer by blocking blood flow to the tumor. Giving fulvestrant together with     bevacizumab may be an effective treatment for metastatic breast cancer.      PURPOSE: This phase II trial is studying how well giving fulvestrant together with     bevacizumab works in treating patients with metastatic breast cancer.   "
197346|NCT00423943|"     Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This     appears to be responsible for their difficulties in social and occupational functioning. One     particular cognitive function that may be important for schizophrenia is called context     processing. This refers to the ability to properly use information in the environment to     guide thinking and behavior so that it is appropriate to the present circumstance. Problems     with this function may explain why patients with schizophrenia think and act in unusual ways,     and often have problems managing aspects of their lives that healthy adults take for granted.     This cognitive function depends on a region of the brain called the prefrontal cortex, which     shows impaired function in schizophrenia as well. Unfortunately, the biochemical aspects of     this dysfunction are presently unknown, and it is not clear whether current psychiatric     medications can improve this function. A recent FDA-approved medication that may improve this     function is modafinil. Studies in animals and healthy adults show that this medication can     improve cognitive functions which are related to context processing. We plan to study the     effects of modafinil on context processing and the brain activity that underlies this     function. We will use functional MRI and electrophysiology to examine the effects of     modafinil, both after a single dose and after sustained (4 week) treatment. We predict that     when patients receive modafinil they will perform better on cognitive tests and have improved     activity in the regions of the brain that are responsible for these cognitive processes.   "
197347|NCT00423956|"     Tooth-root resorption, also known as shortening or erosion,(TRR) is one of the adverse     outcomes of dental trauma, orthodontic tooth movement and dental     replantation/transplantation. Orthodontically induced inflammatory root resorption (OIIRR) is     somewhat different from other types of TRR. The treatment protocol of teeth diagnosed with     severe OIIRR or other forms of TRR always involves root canal treatment or extraction of     these teeth in severe cases and prosthetic replacement. Sometimes teeth with minor TRR may     stay for an extended period of time with compromised bite functions. Although several trials     have been proposed to minimize or prevent TRR or OIIRR, none is capable of being used in     clinical situation to treat TRR or OIIRR in humans except for Low Intensity Pulsed Ultrasound     (LIPUS). However, research examining the use of LIPUS to treat OIIRR has been limited to     simple orthodontic tooth tipping. In reality, tooth movement is a combination of different     types of tooth movements, namely tipping, bodily, rotational, torque, intrusion and extrusion     tooth movements. However, the literature have pointed out that torque tooth movement,     especially when the root apices are torques against cortical plates of bone produces the most     dramatic type of tooth root resorption with poor prognosis. Our long-term goal is to develop     a standard protocol for treating severe tooth root resorption with poor prognosis in humans,     regardless of origin. Our preliminary data demonstrates that LIPUS can produce healing of     OIIRR in humans after simple tipping movement, this was confirmed by an in-vitro study on     isolated cementoblasts. The objective of the present proposal is to evaluate the effect of     different treatment protocols of LIPUS on the healing process of orthodontically induced     tooth-root resorption due to torque (Complex)type of tooth movement in humans.      The study Hypotheses are (I) LIPUS treatment for 20 minutes per day for 4 weeks will be     effective in repairing OIIRR due to torque tooth movement.      (II) The stimulatory effect of LIPUS to repair OIIRR due to torque tooth movement than LIPUS     treatment is dose and time dependent.   "
197348|NCT00423969|"     The purpose of this study is to investigate whether the addition of galantamine to a commonly     used antidepressant, escitalopram (Lexapro), will be useful in the treatment of memory and     other thinking problems that are frequently seen in depression. At present, galantamine is     approved for use in the treatment of Alzheimer’s disease or dementia, but not for use for the     treatment of depression in younger patients.      Possible genetic effects of depressed individuals will also be studied. This study is     involved in collecting blood from patients with depression. DNA, the genetic material in our     cells, will be obtained from these blood samples. The DNA will be studied to determine the     contribution of different genes to the development of depression. These blood samples are     extremely useful to researchers who are trying to determine the genetic risk factors that may     lead to depression.   "
197379|NCT00430040|"     To determine whether addition of Carvedilol CR to diabetic patients with hypertension who are     receiving the ACEi,Lisinopril,will provide added benefits to blood vessels when compared to     treatment with Lisinopril alone.It is believed that carvedilol provides added benefits by     suppressing free radicals(charged substances that cause damage to the body ) and     inflammation.   "
197350|NCT00423995|"     This is study of LMC, phenylephrine, and placebo in subjects with SAR. There are three     visits: At Visit 1, subjects will be evaluated for participation and, if they qualify, will     attend Visit 2 for priming. At Visit 2, ragweed pollen will be fed continuously and dispensed     into the environmental exposure unit to induce an allergic reaction. Pollen counts will be     monitored and recorded. During the priming visit(s), subjects will be evaluated to determine     if they qualify. If qualified, they will return for Visit 3, where ragweed pollen will be fed     continuously and dispensed into the environmental exposure unit to induce an allergic     reaction. Pollen counts will be monitored and recorded as in the Priming Session. Subjects     will complete symptom evaluations and if qualified, they will receive study medication and     remain in the environmental exposure unit where symptoms will be evaluated for 8 hours after     dosing. PNIF will be evaluated only during the treatment session. Four nasal symptoms     (rhinorrhea, nasal congestion, sneezing, and nasal itching) and three non-nasal symptoms     (itching/burning eyes, tearing/watery eyes, and itching of ears/palate) will be evaluated.     Adverse events will be collected throughout the study to assess safety and tolerability, and     vital signs will be collected at Visit 1 and at the end of Visit 3.   "
197351|NCT00424008|"     This study is being conducted to demonstrate the non-inferiority between two inhaled     glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone     furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone     propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the     onset of action, the overall safety, and how the drugs control asthma will also be assessed.     The study is approximately 1 year in duration.   "
197352|NCT00424021|"     AMB-220-E is an international, multicenter, open-label study examining the long-term safety     of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study     NCT00046319, A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging,     Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to     Severe Pulmonary Arterial Hypertension.   "
197353|NCT00424034|"     To investigate the safety, tolerability, pharmacokinetics and the effect of food on     pharmacokinetics after single oral administrations of GSK1325760A   "
197354|NCT00424047|"     The study compared the efficacy of oral lenalidomide in combination with oral pulse high-dose     dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for     participants with relapsed or refractory multiple myeloma.   "
197723|NCT00435526|"     The purpose of this study is to assess anti-CFA/I and anti-CfaE BIgG safety and to determine     protective efficacy of anti-CFA/I and anti-CfaE BIgG against diarrhea after challenge with     H10407, a CFA/I-expressing ETEC strain.   "
197356|NCT00424086|"     The objective of this study is to assess the safety, tolerability and immunogenicity of a     Split Virus, Vero Cell derived, Seasonal Influenza Vaccine (VCIV) in comparison to a Licensed     Egg Derived, Split Virus, Seasonal Influenza Vaccine (EIV) in healthy subjects 18 years of     age and older.      Approximately 1000 subjects will be randomly assigned in a 3:1 ratio to receive a single     injection of VCIV or EIV. Subjects will be monitored for 180 days following vaccination for     occurrence of adverse reactions and for antibody response to the vaccine.   "
197357|NCT00424099|"     The goal of this clinical research study is to learn if methylphenidate (Ritalin) can help to     control fatigue caused by cancer. Its effect on other symptoms such as drowsiness,     depression, sleeplessness, physical activity, and anxiety will also be studied. Another goal     of this study is to learn if receiving a phone call by a nurse improves fatigue in patients.   "
197358|NCT00424112|"     The purpose of this study is to determine if and to what extend a composite measure of     treatment motivation and behavior change motivation predicts alcohol treatment success. It is     expected that the composite measure based on the stages of the Transtheoretical Model of     Behavior Change is a better predictor for treatment outcome than treatment motivation or     behavior change motivation alone. Participants will be recruited from alcohol treatment     centers. A baseline interview regarding their motivation, drinking behavior and personal     treatment goals will be conducted. At the end of treatment, treatment staff will be asked     about treatment involvement of each participant. Two follow-up interviews will be conducted     after 6 and 12 months. To identify the impact of behavior change and treatment motivation on     change in drinking behavior, data will be pooled with a non-treatment seeking sample.     Conclusions can be drawn on what motivation pattern best predicts behavior change for those     utilizing formal help and for those remitting without formal help (self-changers).   "
197359|NCT00424125|"     This study seeks to determine whether education provided in community pharmacies and monthly     reminder calls can improve compliance with asthma medications.      We hypothesize that those pediatric patients with asthma 12 months to 12 years of age who     receive comprehensive asthma care as part of a validated intervention (1) who are randomized     to receive enhanced community pharmacy care will have significantly greater compliance with     inhaled corticosteroids (ICS) six months after enrollment when compared with patients     receiving usual pharmacy care. As secondary outcomes, we further hypothesize that they will     have less unscheduled healthcare utilization and improved functional outcomes and QOL.      (1) Teach SJ, Crain EF, Quint DM, Hylan ML, Joseph JG. Improved Asthma Outcomes in a High     Morbidity Pediatric Population: Results of an Emergency Department-based Randomized Clinical     Trial. Archives of Pediatric and Adolescent Medicine. 2006;160:535-541.   "
197360|NCT00424138|"     RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 (^18FDG) positron emission     tomography (PET)/CT scans, may help doctors predict a patient's response to treatment and     help plan the best treatment.      PURPOSE: This clinical trial is studying ^18FDG PET/CT scans to see how well they predict     response in patients undergoing chemotherapy for stage IIIB or stage IV non-small cell lung     cancer.   "
197361|NCT00424151|"     This study is designed to treat patients with Graves' disease with Rituximab in an attempt to     prevent or reverse the physically deforming and debilitating consequences of this disease.   "
197380|NCT00430053|"     RATIONALE: Gathering information about patients with cutaneous T-cell lymphoma over time may     help doctors learn more about the disease.      PURPOSE: This natural history study is collecting disease-related health information over     time from patients with cutaneous T-cell lymphoma.   "
197362|NCT00424164|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy     using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells.     Giving lapatinib together with tamoxifen may be an effective treatment for breast cancer.      PURPOSE: This randomized phase I trial is studying the side effects of lapatinib and     tamoxifen in treating patients with advanced or metastatic breast cancer.   "
197363|NCT00424177|"     This open-label, repeat dosing study, TRA108057, will evaluate the efficacy, safety and     tolerability of eltrombopag, when administered in a repeat, cyclic dosing schedule. The study     will describe the effect of repeated (3 cycles), intermittent dosing of eltrombopag on the     pharmacodynamics and durability of eltrombopag response as measured by the peripheral     platelet counts.      For more information or to see if you qualify, please visit: http://www.itpstudy.com/gov   "
197364|NCT00424190|"     The purpose of this study is to determine whether ceftaroline is effective and safe in the     treatment of complicated skin infections in adults.   "
197365|NCT00429858|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that may occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict a patient's response to     treatment and help plan the best treatment.      PURPOSE: This phase II trial is studying gene expression in predicting treatment response in     patients receiving gemcitabine and S-1 for locally advanced unresectable or metastatic     pancreatic cancer.   "
197366|NCT00429871|"     The combination of docetaxel+epirubicin is highly effective and well tolerated as first line     treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in     women with MBC pretreated with taxane and anthracycline. Docetaxel increases the     intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine.     The combination of docetaxel plus capecitabine is highly active and superior to docetaxel     monotherapy in women with MBC pretreated with an anthracycline   "
197367|NCT00429884|"     The purpose of this study is to investigate if breathing disorders are related to atrial     fibrillation and if it is possible to predict recurrence of atrial fibrillation after     DC-conversion by changes in heart rate variability and 24 hour ECG.   "
197368|NCT00429897|"     The principle objective of the study is to determine whether low-renin (i.e. salt sensitive)     hypertension at a young age is caused by the kidneys hanging onto too much salt as a result     of an over active salt pump in the kidney.      The kidneys have four different salt pumps, and each is blocked by a different type of     diuretic (salt losing tablet)If one out of the four is overactive, we would expect patients     to respond much better to one diuretic than to the alternatives - rather than responding     equally well to all available types of diuretic.   "
197369|NCT00429910|"     RATIONALE: Gathering information about patients with chronic myelogenous leukemia may help     doctors learn more about the disease and find better methods of treatment and on-going care.      PURPOSE: This natural history study is collecting health information and disease-related     information over time from patients with newly diagnosed chronic myelogenous leukemia.   "
197370|NCT00429923|"     The purpose of this phase III study is to determine the efficacy of difluprednate in the     treatment of inflammation following ocular surgery.   "
197371|NCT00429936|"     The purpose of this phase II study is to determine the efficacy of fenretinide in the     treatment of geographic atrophy (GA) in subjects with the dry form of age-related macular     degeneration (AMD).   "
197372|NCT00429949|"     To evaluate the response rate (Complete Response [CR] and Partial Response [PR]) to dasatinib     in patients with relapsed, refractory or plateau phase multiple myeloma whose serum     paraprotein levels are >0.5g/dL or urine paraprotein levels are >1.0g/24 hours.   "
197373|NCT00429962|"     This pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab     used in combination with verteporfin photodynamic therapy (Visudyne®) compared to ranibizumab     monotherapy for the treatment of subfoveal CNV secondary to AMD   "
197374|NCT00429975|"     The purpose of this study is to compare levofloxacin vs ceftriaxone impact on the cytokine     production in patients with pneumococcal pneumonia.   "
197375|NCT00429988|"     RATIONALE: Collecting samples of fluid using ductal lavage and nipple aspiration from     participants at high risk for breast cancer to study in the laboratory may help doctors learn     more about changes that may occur in DNA and identify biomarkers related to cancer.      PURPOSE: This clinical trial is using ductal lavage to collect fluid from women at high risk     for breast cancer.   "
197376|NCT00430001|"     In an open-label randomised phase III-trial patients with metastatic HER2-positive breast     cancer naive to chemotherapy with normal organ function and WHO performance status < 3 are     randomised to receive either docetaxel 100 mg/m2 i.v. plus trastuzumab 6 mg/kg (8 mg/kg     loading dose) q 3 weeks or vinorelbine 30 or 35 mg/m2 days 1+8 plus trastuzumab 6 mg/kg (8     mg/kg loading dose) q 3 weeks. Primary endpoint is time to progression. Secondary endpoints     include overall survival, time to treatment failure, response rate, duration of response and     toxicity. The study hypothesis is that docetaxel is more efficient than vinorelbine but also     more toxic.   "
197377|NCT00430014|"     Primary Objectives:      The primary objectives of this study are to identify the maximum tolerated dose (MTD) and to     evaluate the safety of atiprimod when given in doses starting at 60 mg/day and ranging to 360     mg/day, or the MTD, whichever is lower, in patients with advanced cancer.      Secondary Objectives:      The secondary objectives of this study are to measure the pharmacokinetics of atiprimod and     to evaluate the efficacy of atiprimod treatment in patients with advanced cancer, and to     compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the     intent of switching to capsules for the dose escalation if the capsules pose no safety     issues.   "
197378|NCT00430027|"     The primary objective of this pilot study is to determine whether neoadjuvant     capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical     resection [and then followed by post operative adjuvant capecitabine, oxaliplatin and     cetuximab] is feasible and tolerable.   "
197381|NCT00430066|"     The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single     agent, in inducing a haematological response in Polycythemia Vera.      The patients will be asked to have additional bone marrow and blood samples collected: these     samples will be used to evaluate how the disease is responding to the drug.   "
197385|NCT00430118|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which     combination chemotherapy regimen is more effective in treating young patients with acute     lymphoblastic leukemia.      PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens     to compare how well they work in treating young patients with acute lymphoblastic leukemia.   "
197386|NCT00430131|"     This project (CO-OP II) is the second in a series of three studies to validate a new     treatment approach for children with cerebral palsy (CP). The initial study was comprised of     a series of four single case studies with children with CP. It evaluated the potential of the     Cognitive Orientation to Occupational Performance (CO-OP) approach to be used with children     with CP and tested the procedures for CO-OP II. The overall objective of the full series of     studies is to determine whether better functional outcomes are achieved for children with CP     with CO-OP intervention than with contemporary occupational therapy treatment.      The primary objective of CO-OP II is to establish the feasibility of conducting a full scale     randomize control trial (RCT) to discover if there are differences in functional outcomes     (i.e., improvement in task performance, self efficacy) between a group of children with CP     receiving CO-OP therapy and a group receiving a contemporary treatment approach (CTA). In     order to meet this objective, a pilot RCT will be conducted to answer the specific research     questions outlined below:        1. Do children wiht CP acquire the skills they set as goals in each of the two treatment          groups?        2. Do the acquired skills generalize and transfer?        3. Are the skills maintained at 4 months post intervention?        4. Does the CO-OP approach produce a larger effect on skill acquisition and self efficacy          than the CTA?        5. Does amount of parent involvement have any effect on skill acquisition or self efficacy?      Completion of this pilot RCT will provide the necessary data to conduct a full study to test     the following hypothesis:      - Children with CP who receive CO-OP treatment will be more successful than children     receiving CTA in improving their performance on child-chosen skills and they self efficacy.   "
197387|NCT00430144|"     -list item one, The purpose of this study is to evaluate the overall response rate of     belotecan (CKD-602) in recurrent or progressive carcinoma of uterine cervix   "
197399|NCT00431574|"     In patients stabilized on their antipsychotic and demonstrating evidence of good clinical     response, there will not be a significant change in symptoms if their medication is decreased     to every 2 days rather than daily. This decrease in antipsychotic exposure will lead to a     reduction in side effects, as well as improved subjective response to treatment.   "
197388|NCT00430157|"     This study is in patients with seasonal allergic rhinitis (SAR) and will compare the effect     versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber.     GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in     development by GSK for the treatment of allergic rhinitis, asthma and COPD.      Subjects will be selected on the basis that they display a defined moderate response to the     pre-determined dose used.      This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients     with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.      12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal     examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge     assessments will also be performed at various time points throughout the study.   "
197389|NCT00430170|"     The purpose of this project is to explore the interaction between caffeine and dipyridamole     on ischemia-reperfusion injury in the forearm.   "
197390|NCT00430183|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as     goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel     and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount     of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and     leuprolide or goserelin before surgery is more effective than surgery alone in treating     patients with prostate cancer.      PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to     see how well they work when given before surgery compared with surgery alone in treating     patients with high-risk localized prostate cancer.   "
197391|NCT00431470|"     Through the use of an educational intervention, the object of this study is to reduce the     prevalence of bullying behaviors among fifth grade school age children. Bullying behaviors     promote an environment of violence , fear, and hostility. The study will arrange to present     six character education lessons in the classroom of fifth grade students in a New York City     public school. Questionnaires will be administered to the students before and after all the     lessons have been completed. Questionnaires will collect information about the students self     perception of their levels of misconduct, impulsivity, confidence, value of non violence,     ways of handling anger, opinions of their leadership behaviors, prevalence of bullying     behaviors, and indications of levels of self esteem. Also, their fifth grade teachers will     complete pre and post treatment student behavioral questionnaires.   "
197392|NCT00431483|"     The purpose of this study is to establish the impact of a pharmacist's recommendations     regarding choice, dosing and duration of antibiotic therapy on quality and cost of antibiotic     treatment on surgical wards.   "
197393|NCT00431496|"     The purpose of this study is to show that the use of cinacalcet in patients with End Stage     Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium     phosphorous product.   "
197394|NCT00431509|"     This study is undertaken to investigate the effect of navigated knee implantation surgery on     physical function, joint stiffness, pain, quality of life and coordinative abilities.      One group of patients will receive navigated knee implantation surgery, the other traditional     knee implantation surgery, without use of the navigation system.      The study is designed as a randomized trial. That means that all patients who have given     their consent to participate in this study will be allocated to either navigated or     conventional surgery by chance.      A total of 477 patients will be included in this study and will be followed up for 12 month.      In this period all patients will be asked to fill in functional and quality of life     questionnaires at baseline, 6 weeks and 3, 6 and 12 month follow-up. Coordinative abilities     will be evaluated once in the time-frame 3 to 6 months postoperatively.   "
197506|NCT00433017|"     This study will evaluate the effect of combination therapy with verteporfin photodynamic     therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the     durability of response observed in patients with choroidal neovascularization secondary to     age-related macular degeneration   "
197395|NCT00431522|"     -  To determine the total and local gray matter volumes, and N-acetyl aspartate (NAA)          levels in patients with bipolar disorders who are within euthimic, depressive or          manic/hypomanic period and who are not taking drug;        -  To investigate the neuroprotective effects of long-term (6 weeks) use of valproate on          total and local gray matter volumes and NAA levels.        -  To measure the brain electrical response to visual and auditory impulses before and          after valproate treatment in patients within euthimic, depressive or manic/hypomanic          period and who are not taking drug, and to compare the data with each other and with          normal groups.        -  To determine the cognitive functions before and after the valproate treatment in the          same patient group, to compare the data with each other and with age- and sex-paired          normal controls;        -  To determine the relationship between these effects of valproate and clinical          improvement;        -  To investigate the relationship between cognitive ability status and electrical activity          of brain, to compare this with that in control group; to determine the relationship          between the data and brain imaging (MRI/MRS) findings in conjunction with localization   "
197396|NCT00431535|"     It is the purpose of the investigators to investigate the possible relationship between fall     in the amount of Oxygen in the blood and disturbances of balance-function before and after     surgery.   "
197397|NCT00431548|"     Ocular lesions, including cotton wool spots and retinal hemorrhage, are a common feature of     HIV infection and acquired immunodeficiency syndrome (AIDS). The aetiology of these     apparently vasoocclusive phenomena in HIV related retinopathy is not well understood. Several     hypotheses including infectious damage of the retinal vasculature and altered retinal     hemodynamics have been postulated. The latter would be compatible with the theory that the     retina of HIV patients is hypoxic. However, direct measurement of oxygen tension in the     retina is not possible and indirect methods have to be employed. The study objective was to     investigate the reactivity in retinal blood flow to 100% oxygen breathing in patients with     HIV.   "
197398|NCT00431561|"     In this multinational dose finding Phase IIb study the efficacy and safety of two doses of AP     12009 compared to standard chemotherapy (temozolomide or PCV) is investigated in adult     patients with confirmed recurrent high-grade glioma.   "
197400|NCT00431587|"     The metabolic risks associated with obesity are closely correlated with central (abdominal),     rather than a peripheral (gluteofemoral) fat pattern It has been shown that weight loss after     bariatric surgery is followed by metabolic improvements.      The amount of fat lost from each site may be independently regulated. Very scant information     is found in the literature regarding the relative changes in different fat body compartments,     and their effect on the improvement of the metabolic profile.      In this study we define the absolute and relative changes in the different adipose tissue     compartment after weight loss surgery   "
197401|NCT00431600|"     Noninvasive monitoring of blood flow in retinal circulation may elucidate the progression and     treatment of ocular disorders, including diabetic retinopathy, age-related macular     degeneration and glaucoma.      Laser Doppler velocimetry (LDV), a noninvasive optical method combined with vessel size     determination has been used extensively as a valuable research tool to examine blood flow     dynamics in the human retina. However, no information on the velocity profile within the     vessel is available. Ophthalmic color Doppler optical coherence tomography (CDOCT) provides     laser Doppler information in addition to conventional optical coherence tomography, allowing     the observation of blood flow dynamics simultaneously to imaging retinal structure.      We have recently demonstrated the feasibility of Fourier domain CDOCT to assess velocity     profiles in human retinal vessels in vivo.      In the present study the validity of Fourier domain CDOCT for retinal blood flow measurements     will be tested at baseline and during hyperoxia-induced vasoconstriction in humans by     comparison with retinal blood flow measurements using a commercially available LDV system and     the Zeiss retinal vessel analyzer (RVA)   "
197402|NCT00431613|"     The combination of chemotherapy with radiotherapy remains the standard of therapy for     patients with stage III NSCLC. A recent phase II study has presented encouraging data     regarding the administration of docetaxel as consolidation treatment after definitive     concurrent chemo-radiotherapy.   "
197403|NCT00431626|"     The purpose of this research study is to determine if the study drug Dutasteride taken before     and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and     safe, long term improvement of lower urinary tract symptoms.   "
197404|NCT00431639|"     This study will examine how animal-assisted therapy (AAT) affects aspects of pain. It will     explore the possible benefits of the National Institutes of Health's AAT program on distress     in cancer patients receiving pain and palliative care at the NIH Clinical Center. A number of     studies on the benefits of patients interacting with companion animals have shown a positive     effect of both pet ownership and AAT for patients with chronic illness. However, few such     experimental studies have been conducted with cancer patients.      Patients 18 years of age and older who have been diagnosed with cancer and have been referred     for consult with NIH's pain and palliative care team and recreation therapy may be eligible     for this study.      Participants have two study sessions, each lasting about 20 minutes on two different days. In     one session, they visit with an animal assistant therapy dog and its handler. In the other     session they engage in a conversation that the patient identifies as non-stressful. Patients     are asked to fill out four forms before and after each session with questions and statements     about their pain, attitude towards pets, symptoms they might be having, and demographic     information, such as age, sex, marital status, and so forth. On four separate occasions, 1     teaspoon of blood is drawn and a swab of saliva is collected from the mouth up to an hour     after the session.   "
197443|NCT00432172|"     This is an open-label study that includes two substudies of random distribution. First,a     sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical     technique to determine several markers.Depending on the expression of these markers, the     patients will be characterize as group 1 (Luminal A phenotype) or group 2 (Basal phenotype)     and a random assignment will be performed to standard or experimental treatment.   "
197405|NCT00431665|"     Type 2 diabetes is frequently associated with elevation of plasma-free fatty acids (FFA).     Studies indicate that elevation of plasma-FFA induces insulin resistance and also causes     endothelial dysfunction as well as hemodynamic changes which are supposed to be involved in     the pathogenesis of diabetic vascular disorders.      Glomerular hyperfiltration, which is associated with glomerular hypertension and hypertrophy,     a common finding in the early course of type 1 diabetes as well as type 2 diabetes, plays an     important role in the development and progression of diabetic nephropathy. These hemodynamic     changes are not well understood, but are most likely induced by dilatation of the     (precapillary) glomerular arteriole.      In humans the hemodynamic effect of FFAs has so far been investigated locally in brachial and     femoral arteries and recently in the eye and skin, where FFAs induced a pronounced increase     in blood flow probably due to a local decrease in vascular resistance.      The aim of the present study is to characterise the hemodynamic effects of FFAs in the     kidney. In addition we want to test the hypothesis that FFA-induced changes are mediated via     endothelial derived nitric oxide (NO). The results of this study could provide information to     what extent elevated FFA-plasma levels contribute to hyperfiltration in the early course of     diabetes mellitus. The measurements will be done at baseline and during 4 hour infusion of a     triglyceride or placebo infusion, combined with heparin.   "
197406|NCT00431678|"     Sequential therapy with intravenous to oral moxifloxacin, was tested at 69 study centres in     17 countries to determine if this treatment regimen is safe and effective in treating     hospitalized adult patients with community-acquired pneumonia. 748 patients were participated     in the study over an 18 months period. Individual patient involvement in the study was     approximately 4-6 weeks. Moxifloxacin was compared to a combination treatment regimen of high     dose intravenous ceftriaxone plus high dose intravenous levofloxacin followed by high dose     oral levofloxacin.   "
197420|NCT00431860|"     The purpose of this study is to validate the usefulness of 64-slice multi-detecter computeted     tomography as a screening tool in asymptomatic population.   "
197421|NCT00431873|"     In this study, MGCD0103, a new anticancer drug under investigation, is given three times     weekly to patients with refractory chronic lymphocytic leukemia.   "
197422|NCT00431886|"     The purpose of this study is to determine the usefulness of 64 slice multi-detector computed     tomography as a first diagnostic approach in acute chest pain patients in emergency room   "
197423|NCT00431899|"     The aim of the study was to determine the effects of a 3-week fish oil oral supplementation     on the metabolic fate and thermogenic effect of an oral glucose load in hemodialysis     patients.   "
197407|NCT00431691|"     Oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates,     has been implicated in many disease processes, especially age-related disorders. Many trials     investigating use of antioxidants in protecting different tissues against oxidative stress     have been conducted, but the results are ambiguous.      Inflammation is generally associated with enhanced oxidative stress and widespread     endothelial dysfunction. In the present study, the infusion of LPS, which is a cell wall     component of Gram-negative bacteria and a major mediator in the pathogenesis of septic shock,     will be used as a standardized experimental model of systemic inflammatory response in     humans. The assessment of outcome parameters will include measurements of ocular blood flow,     forearm blood flow and plasma concentration of cytokines. Measurements of ocular hemodynamics     provide an unique chance to investigate local blood flow in humans non-invasively. Moreover,     the retina is especially susceptible to oxidative stress because of its high consumption of     oxygen, its high polyunsaturated fatty acid content, and its exposure to visible light.     Evidence from literature clearly supports a role for oxidative stress in pathophysiology of     several ocular diseases including diabetic retinopathy and age-related macular degeneration.     To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus.     The measurement of forearm blood flow will be use to assess endothelial function. The main     study objective is to investigate the effect of oral vitamins and minerals supplementation on     impaired retinal vascular reactivity after LPS administration.   "
197408|NCT00431704|"     The purpose of this study is to evaluate the activity and safety of the combination of     vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer.   "
197409|NCT00431717|"     The purpose of this study is to compare the difference of diagnostic efficiency between     coronary CT angiography and myocardial perfusion single photon emission computerized     tomography in asymptomatic patients with type 2 diabetes mellitus.   "
197410|NCT00431730|"     Habitual smoking is associated with an increased risk of coronary artery disease, cerebral     and peripheral vascular disease, including ocular diseases like age-related macular     degeneration or diabetic retinopathy. Data of a recent study performed in the investigators     lab revealed abnormal choroidal blood flow regulation in chronic smokers as compared to     age-matched non-smoking subjects during isometric exercise. However, no information is yet     available about the regulation of retinal vascular tone in habitual smokers.      Thus, in the current study, the investigators set out to investigate whether the regulation     of retinal vessels diameters is affected in habitual smokers. It has been shown in several     reports that stimulation with diffuse luminance flicker, increases retinal arterial and     venous diameters, indicating for the ability of the retina to adapt to changing metabolic     demands. In the current study we use this effect as a tool to investigate whether the flicker     induced vasodilatation is affected in habitual smokers. This would indicate for an impaired     vascular regulation process in smokers.   "
197411|NCT00431743|"     The investigators want to investigate the effects of two different kinds of fluid infusions     given during varicose vein surgery. Both types of fluid are regularly given during surgery,     and the investigators want to compare their respective effects on balance, nausea/vomiting     and orthostatic function after surgery.      The investigators' hypothesis is that using a colloid solution will improve orthostatic     function, balance, nausea/vomiting and reduce hospital stay.   "
197412|NCT00431756|"     The purpose of this study is to determine if there are any early changes in DNA markers of     blood and esophageal tissue in people with gastric reflux, Barrett's esophagus or esophageal     cancer that can warn of a progression to esophageal cancer.   "
197413|NCT00431769|"     The purpose of this study is to evaluate the safety and efficacy of bortezomib in     participants with multiple myeloma who have previously responded to a bortezomib based     therapy.   "
197414|NCT00431782|"     The primary purpose of this study (CLN-504) is to determine the safety and develop a dosing     regimen of an investigational anticoagulant drug (ATI-5923) in patients with atrial     fibrillation.   "
197415|NCT00431795|"     DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical     utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to     potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was     designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy   "
197444|NCT00432185|"     The purpose of this study is to determine maximum tolerated dose level (MTD) of PEP005     Topical Gel for the treatment of superficial basal cell carcinoma on the trunk   "
197416|NCT00431808|"     This study will be the first time that the candidate malaria vaccine Apical Membrane Antigen     1 (PfAMA-1-FVO[25-545]) will be tested in malaria endemic populations. The phase Ib study     will include adults who will be randomly allocated to either receive the malaria vaccine or     the vaccine against Tetanus. Each participant will receive 3 immunizations, without the     clinical investigators or the participants themselves knowing what has been given. They will     then be follow-up up for immediate reactions to vaccination, and also over a longer term of     one year. Blood will be taken to evaluate the biological safety parameters and also immune     responses.   "
197417|NCT00431821|"     Regular exercise has been demonstrated to improve muscle strength, balance, coordination as     well as improve cardiovascular fitness levels and overall quality of life in stroke     survivors. This study is designed to test the feasibility and effectiveness of a 12-week     intervention to education and encourage stroke survivors to exercise following discharge from     rehabilitation settings using a walking program and targeted functional activity homework.   "
197418|NCT00431834|"     This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the     outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery     plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The     trial population includes patients requiring valve replacements or repairs, atrial septal     defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft     (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate     Surgical Ablation System can safely and effectively treat permanent AF patients.   "
197419|NCT00431847|"     The purpose of this study is to examine the short and long-term benefits of implementing     early regional anesthesia techniques for pain control after a major traumatic injury to one     or more extremities during combat in the Iraqi/Afghanistan war, including the effects on     acute and chronic pain, quality of life, and mental health.   "
197424|NCT00431912|"     This phase II study is designed to determine the efficacy and safety of APO866 for the     treatment of patients with advanced forms of cutaneous T-cell lymphoma (CTCL). APO866 has     shown to induce growth inhibition in cultures of human CTCL cells as well as in animal models     with subcutaneously implanted human CTCL tumors. APO866 was considered to be safe and     well-tolerated in a phase I study that treated 24 patients with advanced cancer. APO866 is     administered by intravenous infusion continuously for 96 hours and that is repeated every 4     weeks. Patients will receive 3 cycles of treatment and the primary efficacy endpoint will be     assessed at Week 16. patients will be followed up for 12 months   "
197425|NCT00431925|"     Mucositis and xerostomia are the most common complications of head and neck (H&N)     irradiation, and the combination of chemotherapy and radiation therapy is associated with a     significantly higher rate of complications.      Mucositis usually develops during the second or third week of a course of standard     radiotherapy, and the pain it causes peaks between the third and last week of treatment. The     pain then persists for at least one month following the completion of therapy, and may be so     overwhelming that it prevents patients from swallowing food and fluids. The patient is     therefore at a risk to develop malnutrition, and must be treated vigorously. In this respect,     the use of gastrostomy tubes (PEG) has been shown to be beneficial.      Completion of the full course of irradiation, without interruption, is important for     achieving best possible results in cancer of the H&N. It is therefore essential to identify     and refer patients at risk to receive effective and timely nutritional intervention.      Since mucositis represents a clinical continuum which differs between patients, it is     difficult to assess before-hand which patients will be at risk.      There is no simple laboratory tool available, which could predict which patients are     susceptible to develop severe mucositis and dysphagia, and eventually will require a feeding     gastrostomy.      The first phase of mucositis, inflammation, results in the production of pro-inflammatory     cytokines such as interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α).      In general, the inflammatory cytokines IL-1, interleukin-6 (IL-6) and TNF-α are elevated in     inflammatory conditions and are found in increased levels in blood and tissue fluid during     inflammation, while anti-inflammatory cytokines are produced in a decreased manner.      The main purpose of this study is to find the best indicators and prognosticators of     mucositis occurring in the healthy oral tissues of H&N cancer patients receiving treatment,     and to understand the cytokines balance mechanism of action.      Assuming there is a correlation between high cytokines levels during inflammation and the     severity of radiation induced mucositis, finding these prognostic factors may help us predict     during the first part of the treatment the need for PEG, placing it prior to the     complications associated with severe mucositis on one hand, and avoiding unnecessary     procedures on the other hand.   "
197426|NCT00431951|"     The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a     single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30     healthy, fed volunteers.   "
197427|NCT00431964|"     This is a study to examine the safety, effect on lung function, and frequency of symptoms     relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin in     6-18 year-olds with CF who are not infected with Pseudomonas aeruginosa.   "
197428|NCT00431977|"     The purpose of this study is to evaluate the prevalence and clinical predictors of     subclinical coronary atherosclerosis and to validate the usefulness of coronary CT     angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.   "
197429|NCT00431990|"     The purpose of the first phase of the study is to determine whether, and at what dose,     depsipeptide, bortezomib and dexamethasone can be safely administered to patients with     Multiple Myeloma. The second phase of the study will establish whether depsipeptide,     bortezomib and dexamethasone is effective in the treatment of patients with multiple myeloma.     The study will also examine the role of maintenance therapy with depsipeptide.   "
197430|NCT00432003|"     The purpose of this study is to observe the way two different anti-HIV treatment strategies     affect nerve and brain function in adults with HIV.   "
197431|NCT00432016|"     The purpose of this study is to determine the short term safety, tolerance, and antiviral     effect of zidovudine (AZT) and amdoxovir (AMDX, DAPD) in combination, and whether the dosage     for AZT can be reduced, potentially decreasing side effects, while maintaining antiviral     effects.      Study hypothesis: DADP in combination with AZT is safe and effective, and AZT dosing may be     reduced, resulting in lower levels of AZT-monophosphate associated with toxicity and     maintaining levels of AZT-triphosphate associated with efficacy.   "
197432|NCT00432029|"     A couple of studies have shown that illuminating the eye with diffuse flickering light is     accompanied by an increase of retinal vessel diameters, optic nerve head blood flow and     retinal blood flow. We have recently used this visual stimulation technique as a new and     powerful tool for the non-invasive investigation of vascular reactivity. Additionally, we     could show that this response is diminished in patients with vascular pathologies and that     the response is dependent on nitric oxide, indicating that flicker induced vasodilatation may     reflect endothelial dysfunction and may be a new approach to test endothelial function in     vivo.      One of the most widely used method for the assessment of endothelial function is flow     mediated dilatation (FMD). FMD has been shown to give a reliable estimate of vascular     function in vivo. In the present study, we set out to compare the standard method for the     evaluation of endothelial function, FMD, to flicker induced vasodilatation in the retina.   "
197433|NCT00432042|"     Primary Objective:        -  To demonstrate that ProQuad® can be administered concomitantly with a booster dose of          Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the          antibody response rates to measles, mumps, rubella, varicella, hepatitis B and          Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days          following vaccination.      Secondary Objectives:        -  To describe the antibody titres and the antibody response rates to measles, mumps,          rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and          Haemophilus influenzae type b as measured at 42 days following vaccination by an          Infanrix® hexa primary series schedule and all data are pooled.        -  To evaluate the safety profile of ProQuad® when administered concomitantly with a          booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data          are pooled.   "
197434|NCT00432055|"     The purpose of this project is to investigate if there is a significant difference in active     joint range of motion, questionnaire on gait function and health related quality of life     between patients randomized to treatment with Botulinum toxin type A and patients randomized     to placebo treatment.   "
197435|NCT00432068|"     This study will assess the pharmacokinetic profile, safety and tolerability of an octreotide     extended long-acting formulation after a single dose in humans. It will investigate the     profile of a single dose of drug in a healthy volunteer subject in order to understand the     timing and extent of fluctuations in octreotide concentrations in the blood with this     formulation, the relationship of drug concentration with dose, and how long the drug remains     in the body system.   "
197436|NCT00432081|"     The purpose of this study is determine whether indomethacin is able to retard disease     progression in patients with mild to moderate Alzheimer's disease.   "
197437|NCT00432094|"     RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with     metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor     risk category or others who relapse can be successfully salvaged with high dose chemotherapy     and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential     high dose chemotherapy and AuSCT may improve overall and disease free survival.      PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed     patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose     investigating how well non-cross resistant conditioning regimens work in treating patients     with relapsed or high risk GCT.   "
197438|NCT00432107|"     This phase II study is designed to determine the efficacy and safety of APO866 for the     treatment of patients with advanced cutaneous melanoma. APO866 has shown to induce growth     inhibition in cultures of human melanoma cells as well as in animal models with     subcutaneously implanted melanoma tumors. APO866 was considered to be safe and well tolerated     in a phase I study that treated 24 patients with advanced cancer. In that study one of the     two patients with advanced melanoma had a stable disease for 5 months with size reduction of     some lesions. APO866 is administered by intravenous infusion continuously for 96 hours that     is repeated every 4 weeks. Patients will receive 3 cycles of treatment and the primary     efficacy endpoint will be assessed at Week 16. Patients will be follow-up for 12 months.   "
197439|NCT00432120|"     Clopidogrel pre-treatment before planned percutaneous coronary intervention was proved to     reduce periprocedural complications. However, the vast majority of patients in the current     interventional cardiology practice do not undergo planned PCI, but rather ad-hoc PCI     performed immediately after coronary angiography . Whether clopidogrel should be administered     as pre-treatment to all patients undergoing elective CAG with the aim to ensure therapeutic     levels at the time of possible ad-hoc PCI is not known.   "
197440|NCT00432133|"     The focus of this study is to determine the mechanisms that underlie Physical Activity     behavior change. We have 2 primary objectives. One, to test the effectiveness of brief,     practical interventions to promote and maintain Physical Activity among individuals who are     referred to a treadmill stress test but do not present symptoms of cardiac disease. Two, to     test the potential individual and environmental mediators and moderators of this effect.   "
197441|NCT00432146|"     Context: Although some of endocrine surgeons administer Lugol's solution to decrease thyroid     gland vascularity, there is still no agreement on its effectiveness.      Objective: The aims of this clinical trial are to evaluate thyroid blood flow and microvessel     density in the patients with Graves' disease according to the Lugol's solution treatment     preoperatively.      Design: Retrospective clinical trial. Setting: A tertiary referral center. Method: Thirty-six     patients were randomly assigned to preoperative medication with Lugol's solution. Patients in     group 1 (n=17) received Lugol's solution for 10 days before surgical intervention, whereas     patients in group 2 (n=19) didn't receive it.      Main Outcome Measures: Blood flow through the thyroid arteries of patients with Graves'     disease was measured by color flow Doppler ultrasonography. The microvessel density (MVD) was     assessed immunohistochemically and Western blot analysis using the level of expression of     CD-34 in thyroid tissue. The thyroid gland's weight and blood loss were measured in all     patients.   "
197442|NCT00432159|"     This study is intended to treat patients with symptomatic degenerative disc disease at one     level of the cervical spine. The patients will be randomized to the DISCOVER Artificial     Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety     and efficacy at 2 years post operative. Follow-up on patients treated with total disc     replacement will be continued to 5 years post operative.   "
197446|NCT00432211|"     This study is being undertaken to investigate the efficacy and safety of Juvista (given as an     intradermal injection of 200ng/100µl per linear centimetre of wound margin) in the prevention     or improvement of scar appearance when administered intradermally to approximated wound     margins following surgical scar revision.      In addition, this study will compare the scar revision techniques of complete excision     (excision of the entire scar during one surgical procedure) and staged excision (excision of     the outmost segments and central core separately).   "
197447|NCT00432224|"     The objective of the study is to evaluate the use of sunlight instead of red light during     photodynamic therapy of actinic keratoses using methyl aminolevulinate   "
197448|NCT00432237|"     The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a     placebo for acute migraine.   "
197449|NCT00432250|"     The objective of this study was to investigate the effect of the use of sonographic cervical     length (CL) on the hospital stay in women admitted because of preterm labor.   "
197450|NCT00432263|"     To establish the effects of genotropin replacement in patients with severe growth hormone     deficiency after traumatic brain injury on cognitive function.   "
197451|NCT00432276|"     The purpose of the study is to compare the effect of adding alogliptin, once daily (QD), to     the ongoing treatment regimen of pioglitazone HCl and metformin in patients with inadequate     glycemic control.   "
197452|NCT00432289|"     Specific Aim: to implement and evaluate a research protocol for demonstrating the efficacy of     Acupuncture Therapy to improve neurological recovery after incomplete SCI compared to a     control protocol.      Hypothesis: acupuncture treatment results in greater neurological recovery than a control     treatment after an incomplete SCI.      Before conducting a larger, more definitive study, this exploratory and developmental work is     focused on assessing whether blinding is possible, reproducibility of the outcome measure,     determine enrollment rates and effect sizes and identify clinical resources needed to conduct     a larger study.   "
197453|NCT00432302|"     The purpose of this study is to: a) Determine how the body takes up the test drug and     distributes it into various body organs and tissues, how it processes the drug and how it     ultimately removes it; and b) Examine how well the test drug works against cancer, and     whether it is safe and tolerable to take   "
197454|NCT00432315|"     Primary objective:      • To assess the response rate to induction therapy with docetaxel/CDDP.      Secondary objectives:      To assess        -  Resectability after induction therapy        -  Time to progression        -  Overall survival        -  Safety profile        -  Quality of Life   "
197724|NCT00435539|"     A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical     PVD induction for treatment of patients with vitreomacular traction.   "
197455|NCT00432328|"     Severe scarring is a common problem following breast reduction surgery, studies have shown     that over 64% of patients develop a hypertrophic scar at three months after the operation.     Scar severity can be influenced by a large number of factors including age, sex, skin     thickness and tension, ethnicity and the position of the scar on the body. Therefore the most     sensitive and reliable method to assess the efficacy of an anti-scarring treatment is to     compare bilateral wounds on the same individual. Bilateral breast reduction surgery provides     an ideal model for a within patient evaluation of anti-scarring activity in wounds which     develop into bad scars.      This study is being undertaken to investigate the efficacy and safety of Juvista (given as an     intradermal injection of 200ng per 1cm wound margin) in the reduction of scar appearance     applied to approximated wound margins following bilateral reduction mammaplasty.   "
197456|NCT00432341|"     The purpose of this study is to compare two types of botulinum toxin type A to treat the     involuntary muscle contractions in the neck   "
197457|NCT00432354|"     The aim of this study is to to determine whether atorvastatin 40mg per day is effective in     the treatment of SLE.   "
197458|NCT00432367|"     Among the best practices recommended for malaria control during pregnancy is ensuring     effective case management of malaria illness. However, this is often not practiced because     (1) malaria infection in pregnancy is often asymptomatic, (2) peripheral parasitaemia may be     absent even when the placenta is heavily parasitized, (3) implementing diagnosis and     treatment of malaria within a routine antenatal service may be difficult and (4) antimalarial     treatment options available to pregnant women are limited due to resistance to     chloroquine(CQ) and sulfadoxine-pyrimethamine(SP0 and paucity of safety and efficacy data on     other antimalarial drugs in pregnancy, particularly artemisinin combination treatments (ACT).     Therefore the commonest recommended practice in pregnancy is the administration of SP as     intermittent preventive treatment (SP-IPTp). However, the effectiveness of SP-IPTp has been     questioned because parasite resistance to SP is spreading rapidly across sub-Saharan Africa.      This is a three-arm open label randomised control non-inferiority trial of     insecticide-treated nets(ITN) plus rapid diagnostic test(RDT) screening, and treatment with     SP or amodiaquine plus artimisinin(AQ+AS) versus ITN plus IPTp using SP. It is to be carried     out in pregnant women of all parities presenting at enrolling antenatal clinics with a     gestation of 16 to 20 weeks at their first booking. The key objectives are to demonstrate     that (1) the prevalence of severe anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation (2) the     prevalence of low birth weight (BW < 2500g) at delivery or within 72 hours after delivery (3)     the prevalence of placenta parasitaemia and (4) the incidence of serious and non-serious     adverse events in the ITN plus RDT screening and treatment arm are not greater than those in     the ITN plus IPTp arm. Alongside the clinical assessments, health care cost assessments will     be done to determine the cost-effectiveness of the two delivery strategies measured as cases     of severe maternal anaemia averted.   "
197459|NCT00432380|"     This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid     vaccine when given along with the routine infant immunizations in Philippines.   "
197460|NCT00432393|"     Purpose: There are some controversies about the effect of Levodopa-Carbidopa on treatment of     non-arteritic anterior ischemic optic neuropathy (NAION). This study was performed to     evaluate the effect of Levodopa-Carbidopa on visual acuity, color vision, and visual field in     patients with recent onset NAION (less than 6 weeks duration).      Patients and Methods: In this double-blind randomized clinical trial, 13 patients were     treated with levodopa-carbidopa and 12 patients took placebo for 3 weeks. Visual acuity,     color vision, and visual field were tested before and at 4th, 12th, 16th, and 24th weeks     after enrollment, and evaluated.   "
197461|NCT00432406|"     The purpose of this study is:        -  To elucidate the immunomodulating properties of anti-TNF-α therapy in patients with          psoriatic arthritis (PsA).        -  To ascertain whether magnetic resonance imaging (MRI) is a sensitive tool in measuring          early response after therapy with anti-TNF-α in the PsA wrist using the Outcome Measures          in Rheumatoid Arthritis Clinical Trials (OMERACT) guidelines for rheumatoid arthritis          (RA).        -  To assess whether the lipid and other cardiovascular risk profiles would improve after          anti-TNF-α therapy in patients with PsA.   "
197462|NCT00432419|"     Given the poor prognosis of HIV-associated non-Hodgkin's lymphoma (NHL) and it's still high     incidence in HAART era, more intensive therapy is required in patients with initially severe     stage of NHL or relapsing after first-line chemotherapy.      The purpose of this study is to evaluate the safety of an intensive chemotherapy followed by     peripheral blood cell transplantation in these patients.   "
197463|NCT00432432|"     Combination Methotrexate and Infliximab:Influence of immunogenicity on the efficacy of     infliximab in patients with Ankylosing Spondylitis.   "
197464|NCT00432445|"     The purpose of this trial is to evaluate proton beam radiation therapy as an alternative to     external photon beam irradiation in children with retinoblastoma as a means of local tumor     control and ocular retention.   "
197465|NCT00432458|"     RATIONALE: Zoledronate may prevent bone loss and stop the growth of cancer cells in bone.     Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is     not yet know whether giving zoledronate together with thalidomide is more effective than     zoledronate alone in treating multiple myeloma.      PURPOSE: This randomized phase III trial is studying zoledronate and thalidomide see how well     they work compared with zoledronate alone in treating patients with early stage multiple     myeloma.   "
197466|NCT00432471|"     The goal of this clinical research study is to evaluate an experimental imaging technology,     the multispectral digital microscope (MDM), which may help doctors see how far skin cancer     extends (widens out) on an area of skin. Researchers want to learn if this new technology can     help doctors identify the exact areas involved in precancerous or cancerous changes in the     skin.   "
197467|NCT00432484|"     To study the efficacy of TCM as an effective supplement in addition to the traditional     treatment in RA.   "
197468|NCT00432510|"     The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1     esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not     experiencing an HAE attack.   "
197483|NCT00432705|"     This study is evaluating reflex board training to see if it will help people who frequently     roll their ankles. We are investigating several tests that evaluate the ability of the     neuromuscular system to control ankle movement. This study is in 2 parts:Part 1 looks at     changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex     training. It is thought that the reflex training will improve measures of static and dynamic     balance as well as spinal reflex measures.   "
197484|NCT00432718|"     Compare the incidence of ventilator associated pneumonia with or without tracheal isotonic     saline instillation before tracheal suctioning   "
197725|NCT00435552|"     The application of Ease-it Spray will alleviate pain secondary to fire ant stings more     quickly than placebo.   "
197469|NCT00432523|"     Primary objective:      To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of     age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as     immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates     to measles, mumps and rubella at 42 days following the vaccination.      AND/OR      To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of     age using separate injection sites, a single dose of VARIVAX® administered by IM route is as     immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate     to varicella at 42 days following the vaccination      Secondary objectives:        -  To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days          following the vaccination in children immunised with M-M-R™II and VARIVAX® administered          concomitantly at two separate injection sites by the same route IM or SC,        -  To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at          two separate injection sites by the same route IM or SC.   "
197470|NCT00432536|"     Neurologic injuries are frequent and devastating complications following cardiac surgery.     Previous work conducted by our research group and others has identified the principal     mechanisms creating both overt and subtle neurologic injuries after cardiac surgery. Current     work by our group has identified that the causes (thrombotic/lipid emboli, cerebral     hypoperfusion & hypotension, and gaseous emboli) of these injuries are byproducts of     processes of surgical and perfusion care. This insight suggests that the redesign of clinical     strategies and techniques to prevent the occurrence of these intraoperative sources of damage     may provide an opportunity to reduce the risk of neurologic injury after cardiac surgery.      The goal of this research is to identify modifiable clinical strategies and techniques of     surgical and perfusion care associated with the causes (thrombotic/lipid emboli, cerebral     hypoperfusion & hypotension, and gaseous emboli) of neurologic injury secondary to coronary     artery bypass graft (CABG) surgery, and subsequently to redesign these processes to reduce a     patient's risk of a neurologic injury.   "
197471|NCT00432549|"     The purpose of this study is to assess the benefits of almotriptan used as a transitional     therapy and topiramate in subjects with medication overuse headaches (MOH.   "
197472|NCT00432562|"     This study was a randomized, single dose crossover comparison of the investigational product     with a Reference Product (vinorelbine tartrate injection, NAVELBINE®). The primary objective     was to demonstrate the equivalence of ANX-530 and the Reference Product, NAVELBINE.   "
197473|NCT00432575|"     Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which     might be clinically useful in the treatment of dependence to nicotine.      The primary study objective is the assessment of efficacy of 3 doses of surinabant on     abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of     surinabant on body weight and its clinical and biological safety.   "
197474|NCT00432588|"     Hypothesis (H0): Labor duration and obstetric complications are not significantly different     in the three groups (misoprostol-dinoprostone-oxytocin).   "
197475|NCT00432601|"     The purpose of this study is to test different methods for communicating information about     prostate cancer treatment to men. The investigators are studying how best to present     information so men can make informed decisions about what prostate cancer treatment to     undergo.   "
197476|NCT00432614|"     The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs.     placebo in patients with Major Depressive Disorder who are on concomitant treatment with     escitalopram.      The secondary objective of this study is to document clinical safety and tolerability of     SR58611A in association with escitalopram.   "
197477|NCT00432627|"     This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients     compared to healthy volunteers.   "
197507|NCT00433030|"     Since 2004, the Thai Ministry of Public Health has massively scaled up antiretroviral     treatment programs to provide therapy to more than 80,000 patients with partial support of     the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM).      As access to HIV care continues to expand under the universal health coverage system, it is     important to document and analyze the efficacy, tolerance, toxicity and acceptability of     antiretroviral therapy within pilot treatment programs, to provide evidence based feedback     and recommendations to the national program and policy makers.   "
197478|NCT00432640|"     Lung cancer is one of the most prevalent cancers and has a very high mortality. Both     treatment and prognosis depend on the staging. Surgical staging of the mediastinum mainly by     means of a cervical mediastinoscopy is the gold standard. Mediastinal staging is however a     field that undergoes a fast technological development. Transesophageal ultrasound guided     fine-needled aspiration (EUS-FNA) and an endobronchial ultrasound guided transbronchial     fine-needled aspiration (EBUS-TBNA) are two complementary endoscopic ultrasound techniques     which together allow cytological analysis of all mediastinal lymph nodes. This means that the     combination of both techniques enables a complete (bilateral) mediastinal investigation (N2     and N3, except para-aortal station 6).      Hypothesis: complete endoscopic ultrasound staging identifies more patients with locally     advanced disease compared to surgical staging (current standard of care).      Study design: A randomized controlled multi-center double arm diagnostic phase III trial, in     which patients are randomly assigned to either surgical staging (arm B) or endoscopic     ultrasound staging with both EUS-FNA and EBUS-TBNA (arm A).      Arm A: Examination by EUS-FNA and EBUS-TBNA. These techniques are performed in an outpatient     one session setting under conscious sedation and take together about 30 to 60 minutes. If no     metastasis are shown, the patient undergoes a surgical staging procedure (for confirmation).     For reasons of convenience and patient-comfort, the EUS-FNA investigation is performed before     the EBUS-TBNA.      Arm B: Surgical staging with either cervical mediastinoscopy, parasternal mediastinoscopy,     thorascopic mediastinal exploration or exploratory thoracotomy, performed according to     institutional practice.      Patients in whom no lymph node metastasis are found proceed to thoracotomy with systematic     lymph node sampling to obtain an accurate intraoperative mediastinal staging.      Primary outcome: The assessment of N2-N3 lymph node metastases.   "
197479|NCT00432653|"     To evaluate the efficacy and safety of rituximab when added to NSAIDs and/ or methotrexate     both for TNFalpha inhibitor naïve or TNFalpha inhibitor failure patients with moderate to     severe ankylosing spondylitis   "
197480|NCT00432666|"     IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing     proteins, i.e. free from proteins other than the active toxin. Injected into the muscle,     incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used     for treatment of various neurological conditions. This study will investigate the efficacy     and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the     upper limb.   "
197481|NCT00432679|"     This study was designed to compare the efficacy and safety of BRL49653C versus placebo with     concomitant use of sulfonyl urea (SU).   "
197482|NCT00432692|"     The purpose of this study is to determine wether a falls prevention program can reduce fall     incidence in people with osteoporosis.   "
197486|NCT00432744|"     To show that oral CoQ10 is a safe and effective treatment for children with inborn errors of     mitochondrial energy metabolism due to defects in specific respiratory chain (RC) complexes     or mitochondrial DNA (mtDNA) mutations, and that this beneficial action is reflected in     improved motor and neurobehavioral function.   "
197487|NCT00432757|"     The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with     a contact lens compared to placebo in preventing ocular itching associated with allergic     conjunctivitis   "
197488|NCT00432770|"     The purpose of this study is to establish the overall safety and tolerability of ARC1779 in     healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with     respect to parameters of platelet function and von Willebrand Factor activity.   "
197489|NCT00432783|"     Pharmacologic boosting of protease inhibitors with ritonavir has become standard practice in     antiretroviral therapy. Patients are instructed to take ritonavir at the same time as its     accompanying protease inhibitor. However, ritonavir is unpopular with many patients because     of its large size and because of the recommended need for refrigeration. This study will test     the hypothesis that adherence to ritonavir is inferior to adherence to its accompanying     protease inhibitor in patients receiving such therapy.   "
197490|NCT00432796|"     The purpose of the study is to determine the effectiveness and safety of LMWH postoperative     bridging therapy (standard of care) versus postoperative placebo bridging therapy     (experimental arm)for patients with mechanical heart valves or atrial fibrillation or atrial     flutter who are at high risk for stroke when warfarin is temporarily interrupted for a     procedure.   "
197491|NCT00432809|"     The aim of the study is to compare the relative clinical outcomes between advanced medical     therapy alone or advanced medical therapy combined with bariatric surgery [either Roux-en-Y     gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy] in patients with type 2 diabetes     and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and     long term effects of each intervention on biochemical resolution of diabetes, diabetic     complications, and end-organ damage.   "
197492|NCT00432822|"     The aim of the study is to confirm the efficacy and safety of BH4 in the treatment of     hyperphenylalaninemia caused by phenylalanine hydroxylase deficiency in patients responsive     to BH4. The primary objective is to assess the effect of BH4 on phenylalanine tolerance     compared to placebo under optimal blood phenylalanine control and to demonstrate safety in 12     months long-term treatment. Additionally population PK will be assessed.   "
197493|NCT00432835|"     The purpose of this research is to determine if temporary gastric electrical stimulation will     help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when     the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.   "
197494|NCT00432861|"     The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is     safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations)     in children and adults with cystic fibrosis and pancreatic insufficiency.   "
197495|NCT00432874|"     The study objective is to compare traditional and Wong methods of wound hydration for wound     sealing following cataract surgery.   "
197916|NCT00430794|"     To determine the efficacy of the addition of spironolactone to modern blood pressure lowering     treatment regimens in patients with resistant hypertension (whose blood pressure is     uncontrolled despite three blood pressure lowering drugs)   "
197496|NCT00432887|"     This project contains experimental studies of the effects of the drug caffeine on glucose     regulation in adults who have Type 2 diabetes. In our experiments, we are testing the     hypothesis that moderate amounts of caffeine exaggerate the abnormal increases in glucose and     insulin observed after meals in patients with type 2 diabetes. On separate study days     subjects receive standard meals after taking capsules containing either caffeine or an     inactive placebo. We measure levels of glucose, insulin, and other chemicals in blood samples     drawn over the next 3 hours. In a separate study, we use continuous glucose monitoring to     measure glucose levels during everyday activities on days when subjects receive caffeine or     placebo.      These studies do not involve clinical treatment or disease management. However, we hope to     learn whether a very popular drug impairs the clinical management of a common disease.   "
197497|NCT00432900|"     This study will use positron emission tomography (PET) to measure a brain protein called     peripheral benzodiazepine receptor (PBR) in patients with multiple sclerosis. PBR is created     during the inflammation process, and brain inflammation is a key feature of multiple     sclerosis (MS). PBR usually affects one type of brain cell, but it can also cause damage to     surrounding areas of the brain in patients with MS. PET studies of PBRs and brain     inflammation may help elucidate the role of these brain cells in patients with MS.      Healthy normal volunteers and patients with MS between 18 and 70 years of age may be eligible     for this study. Patients with MS must have had onset of disease between 18 and 40 years of     age.      Patients with MS undergo the following procedures:      Visit 1: Medical history, physical examination, blood tests and magnetic resonance imaging     (MRI).      Visit 2: Blood tests and PET scan.      Visits 3 and 4: MRI and physical examination.      Visit 5: PET scan and blood tests.      Visit 6: MRI and physical examination.      Healthy volunteers undergo the following:      Visit 1: Medical history, physical examination, blood tests.      Visits 2 and 3: PET and blood tests.      Magnetic Resonance Imaging      MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For     this procedure, the subject lies on a table that can slide in and out of the scanner (a metal     cylinder), wearing earplugs to muffle loud knocking noises that occur during the scanning     process. The procedure lasts about 90 minutes; the patient is asked to lie still for up to 25     minutes at a time. The subject can communicate with the MRI staff at all times during the     scan. During part of the scan a contrast agent is administered through a catheter (plastic     tube) placed in an arm vein to enhance the images.      Positron Emission Tomography (PET)      The PET scan gives information on brain and body chemistry and function. The subject lies on     a bed that slides in and out of the doughnut-shaped scanner. A catheter is placed in a vein     in the arm and another is placed in an artery in the wrist or elbow area. The catheter in the     arm is used for injecting a radioactive material that the scanner detects, and the other is     used to collect blood samples. A custom-molded plastic mask is used to support the head and     prevent it from moving during the procedure. The subject may be asked to perform various     tasks during the PET scan or to lie quietly. The scan lasts about 2.5 hours.   "
197498|NCT00432913|"     The purpose of this study is to determine the effect of two doses purified EPA (an omega-3     fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new     cells) in the lining of the colon for patients with a history of colonic polyps.   "
197499|NCT00432926|"     This study tests the effectiveness of a behavioral intervention to reduce sexual risk     behavior in HIV-positive, methamphetamine-using men who have sex with men (MSM). It builds on     the findings of a previous study (R01 DA012116, Promoting safer sex in HIV+ homosexual and     bisexual men who use methamphetamine). That study achieved significant short-term results     that eroded over time. Accordingly, this study hypothesizes that the addition of a     maintenance component to the already proven counseling and educational components of the     treatment model will result in longer-lasting positive effects.   "
197500|NCT00432939|"     This is a research study to investigate cardiovascular health in people with mild     hyperparathyroidism. Previous research has suggested that severe hyperparathyroidism may be     associated with abnormalities in the heart and blood vessels. It is unclear whether mild     hyperparathyroidism affects cardiovascular health. This study involves the investigation of     the heart and blood vessels of people with mild hyperparathyroidism. Various non-invasive     laboratory and radiological test to assess cardiovascular and bone health will be done at set     intervals over the course of 2 years. It is our hypothesis that patients with primary     hyperparathyroidism will have subtle abnormalities in their cardiovascular system. Using     state-of-the art techniques that are sufficiently sensitive to detect these subtle     abnormalities, we will define cardiovascular features of this disease that have, up to now,     eluded clear definition. We expect taht the extent of these findings will be related to the     severity of the underlying primary hyperparathyroidism. We further hypothesize that     cardiovascular manifestations may regress with successful cure of the hyperparathyroid state.   "
197501|NCT00432952|"     The acute effects of farmed rainbow trout, fed by various feeds versus a control meal with     poultry meat on cardiovascular risk markers and plasma protein expression are investigated.      The hypotheses of the study are that if the feed are changed from a marine origin to     primarily a vegetable origin the content of long chain n-3 poly unsaturated fatty acids (n-3     PUFA) will decrease in the meat and thus possibly result in a decreased effect on health.     Furthermore, the feed of the trouts are also expected to give rise to differences in the     human plasma protein profile and fatty acid composition after consumption, which could be     associated with physiological effects.   "
197502|NCT00432965|"     To determine if topical negative pressure therapy delivered by the V.A.C.® device is     clinically efficacious and cost effective in the treatment of diabetic foot ulcers.      The purpose of this study is to compare the effectiveness of V.A.C.® Therapy to moist wound     therapy of diabetic foot ulcers. The primary objective is to determine the effect of V.A.C.®     Therapy on the incidence of complete wound closure. Secondary objectives include: evaluating     the acceleration of ulcer closure or facilitation of surgical closure, reduction of ulcer     surface area over time, reduction in complications, the quality of life and the average total     cost of care.   "
197503|NCT00432978|"     This study is to determine whether bosentan will alter exercise capacity after rapid ascent     to high altitude.      We hypothesize that bosentan administration will improve arterial oxygenation and exercise     capacity.   "
197504|NCT00432991|"     The purpose of this research study is to investigate if the incidence of nausea and vomiting     that subjects experience during and after a Cesarean section can be reduced by giving a shot     of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration.   "
197505|NCT00433004|"     This is a pilot randomized controlled trial to assess the effects of advanced supply of     emergency contraception versus routine care in a teen postpartum population. The goals are to     assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the     prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse     exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to     assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and     unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.   "
197508|NCT00433043|"     Many heart failure patients are unable to reach target beta blocker doses. This study will     address whether cardiac resynchronization therapy (CRT) will enable uptitration of     beta-blockers to target doses and whether it will favorably affect remodeling by reducing     left ventricular end systolic volume (LVESV), with measurable clinical benefit, beyond CRT     alone (without changes in beta-blocker dose).   "
197509|NCT00433056|"     LOTTI study Centers      This a multicenter, multinational study.      Clinical phase: III      Objectives      The primary objective is to compare efficacy and safety of continuing a conventional HAART in     chronically infected HIV patients with a therapeutic strategy based on long term,     immunologically driven treatment interruptions.      Secondary objectives are:        -  To verify the risk of developing viral resistance        -  To verify the effect of the two strategies on metabolic parameters        -  To verify the possibility to steadily discontinue antiretroviral therapy in patients who          started it with baseline immunological values higher than those currently recommended by          international guidelines for HIV treatment        -  To identify predictive variables of the possibility to safely discontinue antiretroviral          therapy        -  To verify the dynamic of CD4+ cell loss and HIV replication after treatment interruption      Number of Patients: A total of 320 patients.      Study design:      Controlled, Randomized, Open study The study will last 5 years      Treatment arms:      Patients will be randomized in a ratio 1:1 to one of the two treatment arms Control group     continuing the ongoing therapy STI group performing long term CD4 guided structured treatment     interruptions In the STI arm patients will stay off therapy until their CD4 count will drop <     350 cells/mcL (one measurement will be considered sufficient). At that time point patients     will resume the HAART regimen they were assuming before STI and will continue HAART until     they CD4 count will raise > 600 cells/mcL (at least 2 consecutive measurements 2 months     apart) and their HIV-RNA will drop below the detection limit of 50 copies/ml (one measurement     will be considered sufficient). When both the CD4 count and the viral load will be within     these pre-set values they will stop therapy again. There is no limit to the number of     interruptions and re-start cycles during the study period      End points:      The primary end-point for the evaluation of the main objective of the study will be clinical.     The primary outcome measure will be based on the occurrence of a clinical end-point defined     as: disease progression (occurrence of any AIDS defining event), death for any cause or the     occurrence of clinical events requiring hospital admission      The secondary objectives of the study will be evaluated on the basis of:        -  Mean variation of blood cholesterol and triglycerides from baseline values.        -  Development of lipodystrophy or modification of a pre-existing lipodystrophy        -  Time off therapy.        -  Variation of CD4 counts and HIV-RNA levels        -  Genotypic tests to be performed in the case of HIV-RNA > 1000 copies/ml while on therapy          for at least 4 months or one month after each treatment interruption.      Statistics:      The study is powered to evaluate equivalence between the two strategies under the assumption     that, in the control arm, the primary end-point would be observed in a proportion of subjects     < 7% and that the same proportion in the STI arm would not exceed 10% with a maximum allowed     95%CI of 12%. 320 patients will be needed for alfa = 5% and 1-beta = 80%. The primary     analysis will be made according to the intention-to-treat approach and therefore no     correction for eventual drop outs is needed. In addition, a secondary per-protocol analysis     will be performed.   "
197510|NCT00433069|"     The aim of this study is to investigate the efficacy and safety of an insulin-sensitizer     (Actos) added to a standard Pegasys/Copegus combination therapy of chronic hepatitis C in     patients who have previously failed a pegylated-interferon-alpha / ribavirin combination     without the insulin sensitizer. The primary endpoint is the initial virological response     (level of HCV RNA in serum) as evaluated after 12 weeks of triple therapy.   "
197511|NCT00433082|"     The metabolic syndrome has been recognized as a proinflammatory state. It has been shown that     many different diets such as Mediterranean diet, DASH diet, Foods with low glycemic index and     low saturated fat diet, independent of weight loss, may be effective in improving the     metabolic syndrome. Our objective was to evaluate the effect of Ramadan fasting on     High-sensitive C-reactive protein (hs-CRP) and fibrinogen levels in metabolic syndrome.   "
197512|NCT00433095|"     1st-line treatment of HER2/neu overexpressing breast cancer   "
197513|NCT00433108|"     A Phase 2, randomized, double-blind, parallel design trial of two doses of mitoquinone     mesylate (MitoQ) and of placebo in patients with chronic Hepatitis C.      MitoQ is a mitochondria-targeted antioxidant that rapidly permeates the lipid bilayer and     accumulates within mitochondria in organs such as liver, brain, heart, skeletal muscle. There     is strong evidence for increased oxidative stress and mitochondrial damage leading to     apoptosis via caspase activation. Several studies have shown that MitoQ protects cells from     apoptosis by acting as a caspase inhibitor and may be effective in reducing cell damage in     liver disease.      It is hypothesised that administration of MitoQ will lower raised ALT seen in patients with     chronic Hepatitis C compared with placebo. Approximately 36 patients who have been     unresponsive or not suitable for interferon-based therapy will be enrolled at one centre.     Treatment duration will be 28 days with 28 days post-treatment follow-up.   "
197514|NCT00433121|"     The aim of this study is to discontinue antipsychotics and antidepressants, and to study its     effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).   "
197515|NCT00433134|"     Goal:      To define the causes and issues associated with nonadherence in our population      Hypothesis:      There is a difference in the rates and patterns of adherence to transplant medications versus     other medications also taken by transplant patients      Methods:        1. A standardized interviewer-administered confidential survey exploring levels of          adherence to transplant medications and other medications as well questionnaires on a          variety of cognitive and other factors known to be associated with adherence.        2. A brief review of demographics and pertinent laboratory information at the same          encounter   "
197516|NCT00433147|"     Gaucher disease is a lysosomal storage disorder resulting from a deficiency in the key enzyme     beta-glucocerebrosidase (GCase). The enzyme deficiency is caused by genetic mutations, which     can result in the production of misfolded GCase. AT2101 is designed to act as a     pharmacological chaperone by selectively binding to the misfolded GCase and helping it fold     correctly, which may restore GCase activity.      This study is being conducted to test the safety of AT2101 in patients with type 1 Gaucher     disease already receiving enzyme replacement therapy (ERT). The study will involve six visits     over a period of 7 weeks and will evaluate the safety of AT2101.   "
197517|NCT00433160|"     To evaluate the efficacy of teriparatide based on measurements of bone mineral density at     lumbar spine   "
197518|NCT00433173|"     The metabolic syndrome is a medical condition defined by high levels of cholesterol in the     blood, high blood pressure, central obesity (gain in fat around the region of the stomach),     and insulin resistance (body responds less well to insulin). This state of impaired insulin     resistance can lead to type 2 diabetes mellitus, which is one of the most common metabolic     disorders in the U.S. Numerous studies have shown an inverse relationship between insulin     resistance and testosterone levels in men, however, causality has not been established. This     protocol investigates the role of testosterone in modulating insulin sensitivity in insulin     resistant states such as the metabolic syndrome. The hypothesis is that testosterone     administration will improve insulin sensitivity.   "
197519|NCT00433186|"     This is a research study of an investigational product called Mycophenolate mofetil (MMF).     The study is designed to establish the safety and potential benefit of MMF. MMF has proven     one of the most effective medications to date for SLE and associated nephritis. It also     appears to be active in polymyositis and dermatomyositis. This medication inhibits inosine     monophosphate dehydrogenase, the rate-limiting enzyme in synthesis of guanosine nucleotides.     It blocks the type II isoform found in activated lymphocytes more potently than the type I     isoform inhibiting both T- and B-lymphocytes. In SSc, MMF has been tried after anti-thymocyte     globulin in one small open label study with efficacy with a significant improvement in skin     score. We will test the safety and efficacy of MMF in SSc. All study patients will receive     the study medication. The effect of the study medication will be examined in two subgroups of     patients: those with early or progressive skin disease (skin substudy) and those with muscle     disease (muscle substudy). The change in modified Rodnan skin score (MRSS) and creatinine     phosphokinase (CK) for, respectively, the skin and muscle substudies at 6 months after     treatment will be compared to baseline values.   "
197520|NCT00433199|"     Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal     men   "
197533|NCT00433381|"     This randomized phase II trial is studying the side effects and how well giving bevacizumab     together with irinotecan or temozolomide works in treating patients with recurrent or     refractory glioblastoma multiforme or gliosarcoma. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood     flow to the tumor. Drugs used in chemotherapy, such as irinotecan and temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving bevacizumab together with irinotecan or temozolomide may kill more     tumor cells.   "
197521|NCT00433212|"     The machines and oxygen used to help very premature babies breathe can have side-effects,     such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher     death rate, a longer time in intensive care and on assisted ventilation, more hospital     readmissions in the first year of life, and more learning problems) than infants who do not     develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the     breathing machine as soon as possible. However, small babies get tired, and still require     help to breathe. One of the standard and common techniques to help them breathe without a     tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway     pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent     the need to go back on the breathing machine.      Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives     some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and     effective, and already in use as an alternate standard therapy.      The main research question: After being weaned from the breathing machine, is NIPPV better     than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?   "
197522|NCT00433225|"     The purpose of this study was to evaluate the efficacy of ketorolac 0.4% on quality of vision     and macula thickening in patients undergoing cataract surgery using the ReStor® multifocal     IOL.   "
197523|NCT00433238|"     The study is designed to answer the following research questions:        1. Evaluate the acceptability of mental health screening and of the instruments used in a          sample of community living Chinese seniors;        2. Determine rates of mental health service utilization in individuals identified at          screening as having psychological disturbance;        3. Determine if identifying mental illness and informing participants of screening results          and with treatment alternatives alters help-seeking pathways.      The study hypotheses are:        1. This community sample of Chinese seniors will show a higher prevalence of psychological          disturbance than their counterparts in the general population;        2. Emotional well-being will be positively correlated with individuals' physical health and          social support network.   "
197524|NCT00433264|"     Despite major advances in the treatment of chronic kidney disease, the age and sex matched     mortality far exceeds that of the normal population. As in the normal population, the     majority of deaths are related to cardiovascular disease. Mounting data point to the lethal     synergy between chronic kidney disease and cardiovascular disease. This relation is present     from early stages of chronic kidney disease on.      Several uremic toxins have been demonstrated to play an important role in kidney disease     related endothelial dysfunction. In peritoneal dialysis patients, data on the relation     between uremic toxins, endothelial dysfunction and microparticles are lacking.      The investigators hypothesize that endothelial dysfunction and uremic toxins are interrelated     in peritoneal dialysis patients   "
197525|NCT00433277|"     Using local immune suppression, the trial seeks evidence for the hypothesis that autoimmunity     plays a role in the pathomechanism of retinitis pigmentosa.   "
197529|NCT00433329|"     An open label, non-comparative study design is appropriate for this Phase 4 study designed to     assess whether a core therapy of bosentan, either as monotherapy or with the addition of     sildenafil, enables patients with pulmonary arterial hypertension (PAH) to achieve a 6-minute     walk distance (6 MWD) of ≥380 meters after 28 weeks of therapy This design is also     appropriate to pioneer the utility of cardiac MRI in assessing improved functional capacity     in PAH and exploring its correlation with other parameters.   "
197530|NCT00433342|"     An important subgroup of protein-bound toxins are generated as a result of protein     fermentation in the colon. P-cresol is a fermentation metabolite of tyrosine. In renal     failure, the colonic generation rate of p-cresol is markedly elevated. After absorption, the     majority of p-cresol is conjugated to form p-cresyl sulphate. There is clear evidence, both     in vitro and in vivo, that accumulation of conjugated fermentation metabolites is correlated     with clinical important endpoints. Free p-cresol is an independent predictor for mortality in     hemodialysis patients.      Moreover, in renal failure patients, neither hemodialysis nor peritoneal dialysis is capable     of normalising the clearly elevated serum concentrations of p-cresyl sulphate. Removal is at     least partially diminished by the important protein binding of p-cresol. Besides adaptation     of renal replacement therapies to improve removal of protein bound solutes, another approach     is to lower the generation of uremic toxins.      The mechanisms underlying colonic carbohydrate and protein fermentation, responsible for the     generation of p-cresol, are only partially understood. On the one hand, the ratio of     fermentable carbohydrates to proteins has been shown to be an important determinant of     protein fermentation. On the other hand, changes in the colonic bacterial flora influence the     generation of p-cresol in dogs and in healthy human individuals.      The effect of antibiotic therapy on bacterial protein fermentation and thus on the generation     of p-cresol is not known. A reanalysis of data abstracted from a recent longitudinal study in     peritoneal dialysis (PD) patients suggests that antibiotic therapy may lower p-cresol levels     substantially. The current study aims at confirming these data in a prospective manner.   "
197531|NCT00433355|"     The purpose of this study is to understand what causes a continuing fatigue for a long time     with a number of symptoms occurring at the same time (Chronic Fatigue Syndrome-CFS). Epstein     Barr Virus is among the group of viruses that have been associated with a continuing fatigue     for a long time with a number of symptoms occurring at the same time, but the cause is still     unknown.   "
197532|NCT00433368|"     The purpose of this study is to determine whether L-Ornithine L-Aspartate is effective for     the improvement of Overt Hepatic Encephalopathy.   "
197607|NCT00415896|"     This study investigates how different degrees of muscular unloading during mechanical     ventilation impact endurance of succeeding spontaneous breathing trials   "
197534|NCT00433394|"     RATIONALE: Collecting informed consent from parents of children with cancer to register with     the Childhood Cancer Research Network may help the study of cancer in the future.      PURPOSE: This study is collecting informed consent to register younger patients with cancer     into the Childhood Cancer Research Network.   "
197535|NCT00433407|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors predict how well patients will respond to treatment. It may also help the study of     cancer in the future.      PURPOSE: This laboratory study is looking at blood samples from patients receiving     trastuzumab and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.   "
197536|NCT00433420|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, paclitaxel, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells. Colony-stimulating factors, such as pegfilgrastim, may increase     the number of immune cells found in bone marrow or peripheral blood and may help the immune     system recover from the side effects of chemotherapy. Giving combination chemotherapy and     pegfilgrastim after surgery may kill any tumor cells that remain after surgery. It is not yet     known whether combination chemotherapy is more effective with or without fluorouracil and/or     pegfilgrastim in treating breast cancer.      PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how     well it works when given with or without fluorouracil and/or pegfilgrastim in treating women     with node-positive breast cancer.   "
197537|NCT00433433|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as     fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a     patient's response to treatment and help plan the best treatment. It is not yet known whether     FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's     lymphoma.      PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how     well it works compared with standard therapy in treating patients with previously untreated     stage I or stage II Hodgkin's lymphoma.   "
197538|NCT00433446|"     RATIONALE: Monoclonal antibodies, such as anti-IL-6 chimeric monoclonal antibody, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them.      PURPOSE: This phase II trial is studying how well anti-IL-6 chimeric monoclonal antibody     works in treating patients with metastatic prostate cancer that did not respond to hormone     therapy.   "
197539|NCT00433459|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which     combination chemotherapy regimen is more effective in treating Hodgkin's lymphoma.      PURPOSE: This randomized phase III trial is studying different combination chemotherapy     regimens to compare how well they work in treating young patients with Hodgkin's lymphoma.   "
197540|NCT00433472|"     RATIONALE: Diagnostic procedures, such as MRI, may help doctors learn how efaproxiral works     in the brain and help plan the best treatment.      PURPOSE: This clinical trial is using MRI to evaluate the effect of efaproxiral on the brain     in patients with recurrent or progressive glioma receiving treatment on clinical trial     NABTT-9806.   "
197541|NCT00433485|"     RATIONALE: Studying samples of blood and tissue from patients with basal cell nevus syndrome     and from healthy participants in the laboratory may help doctors learn more about changes     that may occur in DNA and identify biomarkers related to basal cell nevus syndrome.     Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming     back. The use of sirolimus may keep basal cell skin cancer from forming in patients with     basal cell nevus syndrome.      PURPOSE: This phase I trial is studying topical sirolimus in patients with basal cell nevus     syndrome and in healthy participants.   "
197542|NCT00433498|"     RATIONALE: Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Pravastatin may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by making tumor cells more sensitive to chemotherapy. It     is not yet known whether etoposide and cisplatin or carboplatin are more effective with or     without pravastatin in treating small cell lung cancer.      PURPOSE: This randomized phase III trial is studying etoposide and cisplatin or carboplatin     to see how well they work when given as first-line chemotherapy together with pravastatin     compared with first-line chemotherapy and a placebo in treating patients with small cell lung     cancer.   "
197543|NCT00433511|"     This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and     paclitaxel to see how well they work with or without bevacizumab in treating patients with     cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread     to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast     cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal     antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and     spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the     tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery     and help prevent the tumor from returning. It is not yet known whether doxorubicin     hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without     bevacizumab.   "
197544|NCT00433524|"     RATIONALE: Comparing results of diagnostic procedures, such as computed tomography scan (CT     scan), done before and after radiation therapy to help detect movement of the esophagus may     help doctors plan the best treatment.      PURPOSE: This clinical trial is using CT scan to help detect movement of the esophagus in     patients undergoing radiation therapy to the chest.   "
197648|NCT00427193|"     The purpose of this study is to test the hypothesis that two years of sustained 25% caloric     restriction (CR) in men age 21-50 (inclusive) and women age 21-47 (inclusive) will slow aging     and protect against age-related disease processes.   "
197545|NCT00433537|"     This phase II trial is studying how well giving rituximab together with combination     chemotherapy and bortezomib works in treating patients with untreated mantle cell lymphoma.     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as     cyclophosphamide, doxorubicin, vincristine, and dexamethasone, work in different ways to stop     the growth of cancer cells, either by killing the cells or stopping them from dividing.     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill     more cancer cells.      Treatment consists of six agents: bortezomib (Vc), rituximab (R), cyclophosphamide (C),     vincristine (V), doxorubicin (A), and dexamethasone (D) (VcR-CVAD).   "
197546|NCT00433550|"     This phase II trial studies how well giving irinotecan hydrochloride together with     oxaliplatin and capecitabine works as first-line therapy in treating patients with metastatic     or unresectable locally advanced small bowel cancer. Drugs used in chemotherapy, such as     irinotecan hydrochloride, oxaliplatin, and capecitabine, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     more than one drug (combination chemotherapy) may kill more tumor cells.   "
197547|NCT00433563|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known     which schedule of radiation therapy is more effective when given together with chemotherapy     in treating small cell lung cancer.      PURPOSE: This randomized phase III trial is studying two different schedules of radiation     therapy to compare how well they work when given together with cisplatin and etoposide in     treating patients with limited stage small cell lung cancer.   "
197548|NCT00433576|"     This phase I trial is studying the side effects and best dose of resveratrol in treating     patients with colorectal cancer that can be removed by surgery. Resveratrol may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
197549|NCT00433589|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of     breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the     use of estrogen by the tumor cells. Letrozole may fight breast cancer by lowering the amount     of estrogen the body makes. Giving chemotherapy and hormone therapy after surgery may kill     any tumor cells that remain after surgery. It is not yet known whether genetic testing is     more effective than clinical assessment in determining the need for chemotherapy in treating     breast cancer.      PURPOSE: This randomized phase III trial is studying genetic testing to see how well it works     compared with clinical assessment in determining the need for chemotherapy in women with     breast cancer that is either node-negative or involves no more than 3 lymph nodes.   "
197550|NCT00433602|"     RATIONALE: Chemotherapy may cause blood clots to form in the thigh, leg, and lung. This study     may help doctors understand how often blood clots occur in patients undergoing chemotherapy.      PURPOSE: This clinical trial is studying how often blood clots occur in patients undergoing     chemotherapy for solid tumors, including colorectal cancer, stomach cancer, lung cancer,     ovarian cancer, pancreatic cancer, prostate cancer, or metastatic breast cancer   "
197552|NCT00433628|"     This study will see if HbA1C, the usual blood test for monitoring blood sugar control in     diabetic patients, is as accurate in diabetic patients who also have HIV and will evaluate if     alternative methods for monitoring blood sugar are preferred for HIV infected patients.      HIV-infected patients 18 years of age and older with type 2 diabetes or high blood sugar may     be eligible for this study. Participants have two clinic visits (1 to 4 weeks apart) at the     NIH Clinical Center. At the first visit they provide a detailed medical, social and family     history and have blood and urine samples collected. Previous blood sugar values are also     recorded. At the second visit, scheduled for 1 to 4 weeks after the first visit, blood and     urine samples are collected. Some of the urine and blood samples are stored for future     research on diabetes, HIV or related conditions.   "
197553|NCT00433641|"     Control of food intake, size and frequency of meals are critical to the development of     obesity. The stomach signals feelings of fullness after a meal and therefore plays a role in     control of calorie intake. It is unclear whether the approved appetite reducing drug     sibutramine changes the function of the stomach. Differences in the way individuals respond     to treatment with the appetite suppressant sibutramine may also explain why some people lose     weight while others do not.      In a previous study of 48 overweight or obese participants, we preliminarily observed that     variation in the gene for the promoter of the serotonin transporter protein was significantly     associated with degree of weight loss.      This new single center clinical study aims to evaluate the effects of the FDA-approved     appetite suppressing medication, sibutramine (MERIDIA)on weight loss and stomach emptying in     patients who are overweight or obese. The effect of individual differences in inherited genes     that modify serrotonin and noradrenergic receptors on weight reduction with sibutramine will     be tested.   "
197554|NCT00433654|"     The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic     resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing     System (used in support of Revo MRI™ SureScan Pacing System launch).   "
197555|NCT00433667|"     The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on     treatment of partial onset seizures.   "
197556|NCT00433680|"     The purpose of this study is to evaluate the effectiveness of an obesity prevention program     when administered to female college freshmen.   "
197557|NCT00433693|"     This study will assess the efficacy and safety of intravenous R744 in renal anemia patients     on hemodialysis.   "
197707|NCT00435318|"     The intent of this double-blinded study is to investigate the short (2 months) and long-term     (over 2 months) therapeutic capabilities of Iontophoresis.   "
197558|NCT00433706|"     During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has an     intra-pelvic motion which is not detectable by the conventional portal imaging. This prostate     motion may lead to a mistargeting, which possibly decreases the local control. On the other     hand, the new 3D on board imaging (3D OBI) allows to localize the target but is expensive.     The cost/effectiveness ratio is not well established, as well as the frequency of using such     imaging during the course of radiation.   "
197559|NCT00433719|"     The optimal time to initiate antiretroviral therapy (ART) in HIV-associated tuberculous     meningitis (TBM) unknown. There are concerns that immediate ART may worsen rather than     improve outcome, because drug interactiond and toxicities or development of an intracerebral     immune reconstitution inflammatory syndrome (IRIS). Conversely, delaying ART may result in     increased HIV-related deaths. To answer this question, we are conducting a randomised,     double-blind placebo-controlled trial comparing immediate and deferred ART in HIV-infected     patients presenting with TBM, to assess effect on survival.   "
197560|NCT00433732|"     To determine the efficacy of the Trexima versus placebo as assessed by pain relief and the     incidences of photophobia, phonophobia and nausea at 2 hours after treatment as the primary     endpoints.   "
197561|NCT00433745|"     This study will determine the safety and effectiveness of an experimental vaccine in     controlling the abnormal growth of cells in patients with myelodysplastic syndrome (MDS, also     known as myelodysplasia), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL),     and chronic myeloid leukemia (CML). It will test whether the vaccine can increase the number     of immune cells responding to the cancer and thereby slow progression of the illness, improve     blood counts, reduce the need for transfusions of blood and platelets, or even achieve a     disease remission. The vaccine contains part of a protein that is produced in large amounts     by cells of patients with these cancers and an added substance called Montanide that helps     the immune system respond to the vaccine. Sargramostim, another substances that boosts the     immune response, is also given.      Patients 18 to 85 years of age with MDS, AML, ALL or CML may be eligible for this study.     Candidates are screened with a medical history, physical examination, blood tests, chest     x-ray and bone marrow biopsy. Women of childbearing age also have a pregnancy test.      Participants undergo the following:        -  Chemotherapy entering the study.        -  Leukapheresis to collect large amounts of white blood cells for infusion before vaccine          administration.        -  Participants may need placement of a central line (plastic tube, or catheter) in the          upper part of the chest to be used for giving chemotherapy, blood or platelet          transfusions, antibiotics and white blood cells, and for collecting blood samples.        -  Weekly vaccine injections for nine weeks, given in the upper arm, upper leg or abdomen.        -  Sargramostim injections following each vaccination.        -  Standard of care treatment for MDS, AML, ALL or CML, which may include blood or platelet          transfusions, growth factors, and drugs to control underlying disease and potential side          effects of the vaccine.        -  Weekly safety monitoring, including vital signs check, brief health assessment, blood          tests and observation after the vaccination, on the day of each vaccination.        -  Follow-up evaluations with blood tests and chest x-ray 3 weeks after the last vaccine          dose and with blood tests and bone marrow biopsy 7 weeks after the last vaccine dose.   "
197562|NCT00433758|"     The purpose of this study is to demonstrate the performance of the GlucoTrack device (non     invasive device) in measuring blood glucose levels   "
197563|NCT00433771|"     The overall objective of this study is to assess the functionality of the WallFlex™ Biliary     Fully-covered stent as a palliative treatment for malignant bile duct obstruction.   "
197564|NCT00433784|"     The purpose of this study was to assess whether interpatient variability in the platelet     response to clopidogrel is partly due to polymorphisms of the hepatic cytochrome P450     (CYP450)3A and of the clopidogrel-P2Y12 receptor genes.   "
197565|NCT00433797|"     We will study the effect of dietary intervention in patients with prostate cancer. Outcomes     include serum PSA kinetics, as well as biomarkers of inflammation, antioxidant status,     oxidative stress and oxidative damage in blood cells, plasma, urine and prostate tissues   "
197566|NCT00433810|"     The goal of the LABS-1 study is to assess the short-term safety of bariatric surgery.   "
197675|NCT00434252|"     This Phase II, multicenter, randomized, double-blind, placebo-controlled trial was designed     to estimate the efficacy and characterize the safety of bevacizumab when combined with     carboplatin + paclitaxel chemotherapy compared with carboplatin + paclitaxel chemotherapy     alone in patients with previously untreated metastatic melanoma.   "
197567|NCT00433823|"     Cholesterol is the precursor of glucocorticoids, mineralocorticoids and sex steroids. Both     adrenal and non-adrenal (ovarian + testicular) all steroid hormones are primarily synthesized     using the LDL–cholesterol in the circulation. Additionally there is ‘de novo’ cholesterol     synthesis in both the adrenals and gonads controlled by the HMG-CoA reductase enzyme. A third     pathway is the use of circulatory HDL–cholesterol by the adrenal and gonadal tissues for the     synthesis of steroids. Since statins both decrease circulatory LDL and inhibit de novo     cholesterol synthesis, they are likely to affect the synthesis of steroid hormones. In this     study we aim to investigate the effects of lowering LDL levels below 70 mg/dL on steroid     hormone synthesis.   "
197568|NCT00433836|"     The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of     valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight     stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with     hypertension (SSBP ≥ 95th percentile for age gender and height).   "
197569|NCT00433849|"     This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal     anemia patients on Peritoneal Dialysis.   "
197570|NCT00433862|"     The three main chronic myeloproliferative disorders are polycythemia vera (PV), essential     thrombocythemia (ET) and idiopathic myelofibrosis (IMF). These are clonal neoplastic diseases     characterized by proliferation of one or more hematopoietic lineages. Recently a mutation of     the Janus Kinase 2 (JAK2) gene that leads to the substitution of phenylalanine for valine at     position 617 of the JAK2 protein, JAK2 V617F, has been found in 76% to 97% of patients with     PV, 29% to 57% of patients with ET and 50% of patients with IMF. This mutation confers     constitutive activity on to the JAK2 protein and appears to play an important role in the     pathobiology of these conditions. However, not all patients with myeloproliferative disorders     have this mutation and it may not be the primary cause of these diseases. The primary goal of     this prospective natural history study is to investigate the molecular basis of these     diseases in groups of patients who have JAK2 V617F and in those who do not. A second goal is     to identify biomarkers for PV and the other myeloproliferative disorders that are easier to     measure than JAK2 V617F. Approximately, 150 patients with myeloproliferative disorders will     be studied over 3 years. The studies will involve the collection of 40 mL to 50 mL of     peripheral blood from each subject. The blood will be used to assess neutrophil gene and     protein expression, gene polymorphisms, and plasma protein levels.   "
197571|NCT00433875|"     Twelve week treatment of AMG 714 in RA patients who failed at least one DMARD, followed by a     3 month observational period.   "
197572|NCT00433888|"     This study will assess the efficacy and safety of intravenous R744 in renal anemia patients     on hemodialysis.   "
197977|NCT00437632|"     GSK598809 is being developed as an innovative treatment for substance dependence and     potentially other compulsive behavioral disorders. This study will evaluate the safety,     tolerability and pharmacokinetics of repeat doses of GSK598809 in healthy volunteers.   "
197573|NCT00433901|"     The prevalence of overweight children has increased significantly over the past 3 decades and     3 out of every 4 overweight children become obese adults. Additionally, overweight children     are now at risk for developing type-2 diabetes while still in their youth. To address the     issue of childhood weight management, Golan and colleagues provided a model for intervention     development that targets parents as an exclusive agent of change when attempting to treat     weight issues for children under 12 years of age. The Kaiser Permanente Colorado (KPCO)     Weight Management Program (WMP) developed Family Connections, a condensed two-session     program, based on the Golan model, for parents of children between the ages of 8-12 with a     Body Mass Index (BMI) greater than the 85 percentile for age and gender. There is a need to     determine if the content of Golan's model can be translated into a practical intervention to     be used in usual pediatric weight management practice. The Family Connections study uses     three arms to determine the effectiveness of healthy eating and active living messages.   "
197574|NCT00433914|"     To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B     Recombinant Vaccine when administered to healthy infants.   "
197575|NCT00433927|"     The FIRE-3 trial is a multicenter randomized phase III trial investigating 5-FU, folinic acid     and irinotecan (FOLFIRI) plus cetuximab versus FOLFIRI plus bevacizumab in first line     treatment of metastatic colorectal cancer. Planned accrual is 284 evaluable patients per     treatment arm. The primary study endpoint is objective response rate. Secondary endpoints are     median progression free survival, median overall survival, safety, and secondary resection     rate.   "
197576|NCT00433940|"     The goal of this study is to clarify the degree of immune suppression in infants requiring     therapy and to create guidelines for evaluation and prevention of infection in infants on     oral steroids for hemangiomas.   "
197577|NCT00433953|"     The purpose of this study is to determine how genes influence the response to mycophenolate     mofetil (CellCept) in children who have had a kidney transplant. The study will look at how     differences in some genes effect blood levels of mycophenolate mofetil over time in children,     how often side effects occur and the way that children respond to mycophenolate mofetil.      The results may lead to better dosing based on individual needs.   "
197578|NCT00433966|"     The primary objectives of the trial are:        1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa          inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in          patients with acute myocardial infarction undergoing a primary angioplasty strategy.        2. To establish the safety and efficacy of the slow rate release paclitaxel-eluting TAXUS™          stent compared to an otherwise identical uncoated bare metal EXPRESS2™ stent.   "
197614|NCT00415987|"     The treatment assignment is based on the presence or absence of an HLA-identical sibling     donor (Genetic Randomisation, NOT formal Randomisation). Patients with suitable HLA-identical     sibling donors are offered a tandem transplant approach consisting of standard autografting     nonmyeloablative radiotherapy and allografting. Patients without HLA-identical siblings are     treated with standard double autologous transplantation as per Institutional guidelines or     enrolled in other treatment programs approved by local IRBs.This is a multi-center study. The     Division of Hematology of University of Torino at the S.G.B. Hospital, Torino, Italy, is the     co-ordinating Center.   "
197716|NCT00435435|"     The aim of this study was to compare the effect of manual based cognitive therapy in adjunct     of three different pharmacotherapy.   "
197579|NCT00433979|"     Women represent an increasing proportion of HIV cases globally and in Canada, yet are     underrepresented in clinic trials. It is therefore critical to conduct this study on     antiretroviral (ARV) pharmacokinetics (PK) in women to obtain additional information on ARV     drug levels in women and their relation to adverse events (AEs).      The hypothesis for this study is three-fold:        1. that the mean drug levels (Cmin and Cmax) of ARVs will be significantly higher in our          female population as compared to the mean drug levels in the historical HIV population          (which is primarily men)        2. that ARV drug levels, particularly Cmin, are associated with body weight in women        3. that higher ARV drug levels, particularly Cmax, are associated with higher frequency and          severity of AEs.      The objectives of this study are as follows:      Primary objectives:        1. To demonstrate that levels of Protease Inhibitors (PIs) and Non-Nucleoside Reverse          Transcriptase Inhibitors (NNRTIs) are significantly higher in our female population as          compared to the mean drug levels in the historical general population (which is          primarily men).        2. To determine the association between PI and NNRTI minimum concentration (Cmin) and body          weight in our female population.      Secondary objectives        1. To determine the association between maximum concentration (Cmax) and the frequency and          severity of AEs as measured by the proportion of patients with grade 2 or higher          laboratory or clinical AEs and the Symptom Index Score in women.        2. To determine the association between ARV drug levels and age, race, height, body mass          index, adherence, hormonal levels and therapy, menstruation history, duration of HIV          infection, duration on ARV therapy, baseline viral load, baseline CD4 count, present CD4          count, hepatitis B or C infection, class of ARVs, presence of ritonavir and other          medications.   "
197580|NCT00433992|"     The purpose of this study is to observe the effects of certain anti-HIV medications on     mitochondrial activity and fat cell death. This study will enroll participants from another     study, ACTG A5202, who are on treatment regimens that do not include zidovudine, stavudine,     or other thymidine-containing anti-HIV medications.   "
197581|NCT00415558|"     The purpose of this prospective, single-arm, un-blinded, multi-site clinical study is to     assess the safety and efficacy of the Microwave Ablation System for the treatment of     symptomatic paroxysmal atrial fibrillation (PAF) in the minimally invasive surgical (MIS)     procedure in approximately 30 patients at 6 investigational sites in the United States.   "
197582|NCT00415571|"     The objective of the study is to assess and compare the preliminary efficacy, safety and     tolerability of fispemifene 300 mg and placebo given once daily for 8 weeks in the treatment     of hypogonadal men with erectile dysfunction (ED) unresponsive to PDE5 inhibitors.   "
197583|NCT00415584|"     Secondary hyperparathyroidism can persist following successful renal transplantation and can     cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other     problems. If the condition does not resolve, surgery is frequently required to remove the     parathyroid glands, with all the inherent risks of surgery. Cinacalcet, a medicine used to     treat secondary hyperparathyroidism in patients with kidney disease, may be effective in     treating this condition in the renal transplant recipient. We will study the effect of     cinacalcet on calcium, bone and renal function in a 6 month treatment protocol.   "
197584|NCT00415597|"     Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered     for up to 12 months.   "
197585|NCT00415610|"     The purpose of this trial is to evaluate the safety and effectiveness of lowering blood     pressure using nicardipine in persons with acute hypertension associated with intracerebral     hemorrhage.   "
197586|NCT00415623|"     The changes in the trough systolic blood pressure from the baseline were assessed after 8     weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg   "
197587|NCT00415636|"     The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for     the treatment of cancer.   "
197588|NCT00415649|"     The purpose of this study is to evaluate the safety and tolerability of and immune response     to an HIV DNA vaccine followed by an adenoviral vector HIV vaccine in healthy African adults     at risk for HIV infection.   "
197589|NCT00415662|"     In order to assess the effectiveness of biomagnetic therapy (PST) in the treatment of     gonarthrosis, we conducted a randomized, double blind controlled clinical trial comparing one     group of patients treated with PST and a second group of patients treated with conventional     physical therapy.   "
197590|NCT00415675|"     Primary Objectives:        -  To collect accurate and reliable respiration-induced anatomic structure motion data          using four-dimensional (4-D) imaging technology.        -  To analyze these data to study respiration-induced variations and patterns in variations          of positions, shapes and volumes of tumors and normal anatomic structures in the thorax          and abdomen over a breathing cycle, from one breathing cycle to the next, day-to-day and          over the course of radiotherapy.        -  To assess dosimetric and potential clinical consequences of respiratory motion in the          current practice of radiotherapy through preclinical treatment simulation (treatment          planning) studies.        -  To quantify the potential consequences of explicitly accounting for respiration-induced          motion on dose distributions and outcome (tumor control probabilities and normal tissue          complication probabilities) through preclinical treatment simulation studies.      Secondary Objectives:        -  To investigate the feasibility of using patient training to regulate patient breathing          and improve the quality of images and to stratify patients for their eligibility for          respiratory-correlated imaging and radiotherapy and for the implementation of various          strategies for mitigation of respiratory-induced motion.        -  To assess the degree of correlation of the marker (or internal anatomic structure such          as diaphragm) being tracked as surrogate of breathing with the motion of structures and          the intra-fraction and inter-fraction reproducibility of such correlation.        -  To quantify the effects of radiation therapy on the patterns of respiratory-induced          motion of structures through preclinical treatment simulation studies.        -  To compare various strategies for either accounting for or mitigating          respiration-induced motion in the planning and delivery of radiation therapy.   "
197591|NCT00415688|"     Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary     evidence suggests that low carbohydrate diets improve glycemic control when accompanied by     weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate     during weight loss, we compared two weight loss diets with different carbohydrate levels for     the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.   "
197592|NCT00415701|"     The purpose of this study is to evaluate the effect of a single dose of etomidate for     patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CPB) on post-CPB     adrenocortical responsiveness, on requirements of hemodynamic support, and on use of     intensive care resources.   "
197593|NCT00415714|"     The objective of this study is to determine the efficacy of a portable biofeedback device on     improving sleep latency and other sleep variables such as nocturnal awake time and daytime     functioning in persons with primary insomnia.   "
197594|NCT00415727|"     The hypothesis is that in sickle cell anaemia, nocturnal oxyhaemoglobin desaturation, is     associated with low processing speed index, and this morbidity can be reduced with overnight     auto Continuous Positive Airways Pressure and/or oxygen supplementation.   "
197595|NCT00415740|"     The purpose of this study is to assess the safety and bioequivalence of a single oral dose of     carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa     combination plus a single oral dose of entacapone under fasting conditions in healthy     volunteers.   "
197626|NCT00416143|"     sudden sensorineural hearing loss:        -  idiopathic in most cases        -  5-20/100,000 new cases annually in the U.S        -  no establishes pathogenesis        -  treated with oral steroids in most cases        -  ~50% improvement in hearing levels        -  bed rest - acceptable treatment, not well investigated   "
197596|NCT00415753|"     Objective: To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish     Hospital setting. To test if it is possible to reduce the use of antibiotics and the length     of stay in hospital, and the willingness of the clinicians to take this new marker under     advisement in their choice of treatment.      The study is a randomised, controlled intervention study. All adult patients admitted to the     Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract     infection (e.g. CAP, acute exacerbation of COPD and bronchitis) are eligible for inclusion.     Patients are randomised to have either PCT guided treatment or standard care, in which case     the doctor will not learn the PCT test result. In the PCT group the antibiotic treatment will     be based on serum PCT as follows: If PCT is less than 0.25 µg/L antibiotic treatment is     discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT     is greater than 0.5 µg/L antibiotic treatment is strongly encouraged. The treating doctor is     allowed to overrule the treatment guidelines. The control group will receive antibiotics     according to usual practice.      The primary endpoints are antibiotic use and length of stay in hospital. Secondary endpoint     is the proportion of patients where the treating doctor chooses to disregard the guidelines.   "
197597|NCT00415766|"     The purpose of this study is to compare the clinical outcomes of recombinant human chorionic     gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.   "
197598|NCT00415779|"     This phase I trial is studying the side effects and best dose of docetaxel when given with     zoledronic acid in patients with bone metastasis from prostate cancer that has not responded     to hormone therapy.   "
197599|NCT00415792|"     hCG and GnRH agonist can be used to induce final oocyte maturation and ovulation in IVF     cycles. These two approaches will be compared in this study in terms of pregnancy rates and     embryological data using patients with hyper-response to IVF drugs.   "
197600|NCT00415805|"     This is an explorative small pilot study comparing two MRA contrast agents, one of which has     been on the market for a few years and the other fairly new to the market. Since the study is     explorative and designed to provide preliminary information for consideration for a future     larger study, sample size is not based on statistical assumptions.   "
197601|NCT00415818|"     The primary Objective is to assess the efficacy of TG4010 combined to chemotherapy in     comparison with chemotherapy alone in patients with advanced non small cell lung cancer.   "
197602|NCT00415831|"     The purpose of this study is to assess the safety and bioequivalence of a single oral dose of     carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa     combination plus a single oral dose of entacapone under fed conditions in healthy volunteers.   "
197603|NCT00415844|"     The purpose of this study is to assess the safety and bioequivalence of a single oral dose of     carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa     combination plus a single oral dose of entacapone under fasting conditions in healthy     volunteers.   "
197604|NCT00415857|"     The goal of this clinical research study is to find out if using the PR1 peptide vaccine     (PR1) without PEG-Intron® (interferon) or in combination with interferon can reduce or     eliminate disease in patients who have CML that is in cytogenetic remission after treatment     with imatinib mesylate, but who still have small amounts of disease able to be noticed     (detected). Researchers want to see if giving low doses of interferon together with PR1 may     make the vaccine more effective. The safety of treatment in this study will also be studied.   "
197605|NCT00415870|"     This is a NCI funded study which will develop and evaluate a cell phone application (mDIET)     that can be used as an assessment and intervention tool to improve dietary behaviors and thus     reduce weight in overweight and moderately obese (BMI 25-34.9) men and women ages 25-55.   "
197606|NCT00415883|"     The purpose of this study is to assess how the body changes the blood level of single dose of     valsartan 160 mg tablet Japanese formulation and valsartan 160 mg tablet global formulation     under fasting condition in healthy volunteers.   "
197608|NCT00415909|"     Objectives:        -  To determine the response rate and duration of response with combination of TALL-104          cells and imatinib mesylate (IM) therapy in patients with chronic myelogenous leukemia          in chronic phase, that have not achieved, or have lost, adequate response to IM.        -  To determine the toxicity of the combination of TALL-104 cells and IM therapy in this          patient population.   "
197609|NCT00415922|"     The purpose of this study is assess the safety and bioequivalence of a single oral dose of     carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa     combination plus a single oral dose of entacapone under fasting conditions in healthy     volunteers.   "
197610|NCT00415935|"     A comparison of outcome in children with JIA who are in remission on MTX, when MTX is then     stopped for either 6 or 12 months   "
197611|NCT00415948|"     The purpose of the study is to procure blood samples from patients who present to the     Emergency Department with suspected ACS (Acute Coronary Syndrome).   "
197612|NCT00415961|"     This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to     the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in     in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.   "
197613|NCT00415974|"     This 12-month randomized controlled trial, sponsored by NIH/NCI, aims to reduce BMI in obese     adolescents (ages 11 -13) by intervening on physical activity and nutrition behaviors within     primary care settings.      PACE-PC is a theory-based stepped care program that enables pediatricians and primary care     providers to intervene with obese adolescents to improve their anthropometric, metabolic,     physiological, behavioral, and quality of life outcomes over a one-year period. The program     integrates clinician counseling, health educator counseling, and phone and mail contact. It     supports tailoring to the needs of obese adolescents and family members and promotes improved     diet and physical activity behaviors, weight loss, and ultimately weight loss maintenance.      Participants will be randomly assigned to the Enhanced Usual Care or the PACE-PC stepped care     condition. The Enhanced Standard Care condition includes an initial visit and counseling by a     physician, 3 visits with a health educator, and materials on how to improve weight related     behaviors.      The PACE-PC Stepped Care condition includes 3 steps (each lasting 4 months), with the first     step being the most intensive:      Step 1 includes: a physician visit, monthly health educator visits, biweekly phone     counseling, and weekly dissemination of nutrition and physical activity information      Step 2 includes: a health educator visits every other month, biweekly phone counseling, and     weekly dissemination of nutrition and physical activity information      Step 3 includes: monthly phone counseling and weekly dissemination of nutrition and physical     activity information      Participants randomized to the PACE-PC condition will be enrolled in Step 1 (the most     intensive) for the first 4 months. Depending upon response at the end of Step 1, for the next     4 months adolescents will be triaged to Step 2 (less intensive) or will repeat Step 1. At 8     months, again based upon treatment response, triage will occur to either Step 3 (least     intensive) or repetition of the previous step.   "
197717|NCT00435448|"     The purpose of this study is to evaluate the efficacy of lonidamine (50mg, 150mg) compared to     placebo in subjects with symptomatic BPH.   "
197615|NCT00416000|"     It has been estimated that 80% of deaths from abdominal aortic aneurysms results from     rupture. Endovascular Aneurysm Repair (EVAR) has been applied to RAAA (Ruptured Abdominal     Aortic Aneurysm) patients with reports of improvements. Despite the use of EVAR, patients     have developed complications with lung and kidney function. This study will investigate     certain biochemical processes that will potentially reduce these complications. Knowledge     gained from this study may also be used to further research in this field through larger     studies.   "
197616|NCT00416013|"     Beta Natriuretic Peptide (BNP) is regarded as the most sensitive test for congestive heart     failure (CHF). BNP has also been found to be highly predictive of other conditions including     pulmonary hypertension, pulmonary embolism and in the general population where mild increases     are associated with stroke and heart attack. BNP is also weakly and variably correlated with     renal function.      We believe that each dialysis patient will have an ideal or dry BNP level which will     accurately and reproducibly reflect their optimal fluid status. Secondary hypotheses are that     baseline BNP and troponin, as well as changes in BNP and troponin during dialysis, will be     highly predictive of mortality and adequacy of dialysis.   "
197617|NCT00416026|"     The purpose of the study was to test a telephone counseling intervention for patients after     leaving the hospital for a heart attack to use medication, exercise, healthy eating and     smoking cessation to prevent further heart attacks.   "
197618|NCT00416039|"     It is a randomized simple-blind monocentric study; the group A will receive oral morphine     with placebo and the group B will receive oral morphine with sublingual midazolam. The aim of     this study is to show a more important pain decrease in the group taking midazolam versus     placebo.   "
197619|NCT00416052|"     Accumulating evidence indicated that renal calcium stone formers often exhibit a low bone     density. Therefore we want to test the hypothesis, that the mineral (calcium) metabolism is     differently regulated in calcium stone formers with low as opposed to high bone density.   "
197620|NCT00416065|"     The purpose of this research is to evaluate the presence, location and intensity of FDG     uptake in the large arteries using the new technology of fused PET/CT imaging and to compare     FDG uptake with the presence of arterial calcifications as seen on the simultaneously     acquired CT, in order to determine if FDG was increases incalcified plaque or in a different     location in the arterial wall. we will also evaluate the relationship between FDG     localization and future cardiovascular events in out patient population   "
197621|NCT00416078|"     This study is piloting an internet-based intervention to provide support for caregivers of VA     patients with Alzheimer's disease or related memory difficulties (ADRD). Veterans with a     clinical diagnosis of ADRD and their caregiver/relatives will be randomized to receive one of     two interventions: (1) customary care (cc) and access to an intensive, interactive online     education and support website intervention for 6 months, or (2) cc and monthly brief     telephone calls with project staff for six month. It is hypothesized that participation in     the intensive intervention will result in a reductions in patient problematic behavior and     caregiver responses to it, reduced caregiver burden and depression, and improved medication     adherence at the end of treatment, and more patients remaining at home through the 12 months     post-randomization period..   "
197955|NCT00431301|"     Progressive supranuclear palsy (PSP) is the most common atypical parkinsonian movement     disorder. This study will determine the role of specific genetic, occupational and     environmental components in the development of PSP by evaluating patients with this disorder     and age and gender matched controls.   "
197622|NCT00416091|"     Tourette's disorder (TD) is a childhood-onset neuropsychiatric disorder, manifesting motor     and vocal tics with increased likelihood of comorbid with attention-deficit/hyperactivity     disorder (ADHD) and other psychiatric disorders. Literature documents the comorbid condition     with ADHD predicts an increased functional deficit among individuals with ADHD. The     information about neuropsychological functioning among individuals with TD adn/or ADHD is     little in Asian population. This study aims to validate the diagnoses of TD, ADHD, and TD     comorbid ADHD by symptomatology, neuropsychological measures, and social adjustment. This is     a case-control study with a sample of 30 subjects with TD, 60 with ADHD, 30 with TD+ADHD, and     60 controls aged from 6 to 18. All subjects will receive comprehensive assessment including     standard psychiatric diagnostic interviews using (K-SADS-E), behavioral assessments (SNAP-IV,     CPRS:R-S, CTRS:R-S, CBCL, YBOCS, YGTSS), social adjustment (SAICA, GCAS), parenting (PBI,     APGAR) and neuropsychological assessment (CPT, CANTAB, WISC-III). We anticipate that this     study will provide the primitive data to validate the TD and ADHD using neuropsychological     and clinical measures.   "
197623|NCT00416104|"     The aim of this retrospective study is to find out if one or more of the following parameters     has an impact on postcesarean section pain:age,ethnic origin, parity,body habitus, smoking,     breastfeeding, education,newborn in intensive care unit, primary/repeated     operation,elective/emergency operation,junior/senior surgeon,type of anesthesia during     operation.   "
197624|NCT00416117|"     Mounting evidence does support the combined use of manual physical therapy (MPT)and exercise     for patients with cervicogenic headache and mechanical neck pain. However, there is     insufficient evidence to assess the effectiveness of MPT and exercise for patients with neck     disorders with radicular symptoms. Our purpose for this study was to determine the     effectiveness of a manual physical therapy and exercise program as compared to a minimal     intervention approach in the treatment of patients with mechanical neck pain, with or without     upper extremity symptoms.   "
197625|NCT00416130|"     Purpose:        -  evaluate the safety of Vorinostat.        -  evaluate the effectiveness of Vorinostat in treating breast cancer        -  evaluate how the study subject's body reacts to Vorinostat, how these reactions relate          to the subject's genes, and whether protein changes in the subject blood may be used to          predict how the subject's cancer will respond to Vorinostat      We hypothesize that Vorinostat, as a novel class of anti-cancer agents, may induce response     in patients with recurrent or metastatic breast cancer who have been previously treated with     anthracyclines and taxanes. In addition, we hypothesize that serum Vorinostat levels may     correlate with clinical response and toxicities, and that Vorinostat may induce unique     protein changes in the plasma in responding patients, and that these proteins may in turn be     used as predictive biomarkers for treatment response.   "
197718|NCT00435461|"     The primary objective of this study is to compare the nighttime symptom relief of fluticasone     furoate nasal spray and oral fexofenadine   "
197628|NCT00416169|"     The purpose of this study is to explore the safety and tolerability and the efficacy of     galantamine treatment in subjects with Pick Complex/ Frontotemporal Dementia (PC/FTD). The     safety and tolerability of galantamine therapy will be assessed over the entire treatment     period (26 weeks). The 8 week withdrawal period will be used to confirm the safety of     galantamine withdrawal in this subject group and it impact on any symptom improvement     achieved during the first 18 weeks of galantamine treatment ( symptom improvement would be     expected to stabilize or decline on withdrawal of an effective therapy).      The primary efficacy objective is to explore the effect of galantamine on behavior as     measured by the Frontal Behavioral Inventory during the randomized withdrawal period. In     addition, for subjects with primary progressive aphasia (limited ability for languages), the     effects of galantamine on language will be explored using the Aphasia Quotient of the Western     Aphasia Battery, and for all subjects the Clinical Global Impressions will be used to explore     global change.   "
197629|NCT00416182|"     Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to     determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo)     in patients with cystic fibrosis who have recently undergone sinus surgery.   "
197630|NCT00416195|"     This is a randomized, double-blind, placebo-controlled, parallel group study to determine the     maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be     divided into two groups of 24 patients each. One group will be patients who take concomitant     inducing AEDs (anti-epileptic drugs) and the second group will be patients who do not take     concomitant inducing AEDs. In each group, 18 patients will receive E2007 (dose escalating to     a maximum of 12 mg per day) and six will receive placebo.   "
197631|NCT00416208|"     The purpose of this study is to evaluate the efficacy and safety of a consolidation therapy     with bortezomib in patients with multiple myeloma aged 61 to 75.   "
197632|NCT00416221|"     Researchers at the University of California at San Diego (UCSD) are conducting a 12-week     study to test the PACEPRO program. This program is designed to reduce depression by     providing:      Lexapro, an antidepressant medicine…Learn More Physical activity information and pedometer     Mood management skills and a Mood Mastery Guide Personalized support from a Family Nurse     Practitioner   "
197633|NCT00416234|"     The purpose of the study is to assess whether combined intraoperative ERCP and CBD clearance     with laparo-endoscopic rendez-vous during laparoscopic cholecystectomy (one stage approach)     is or not superior to the standard practice of preoperative ERCP, sphincterotomy and CBD     clearance followed by laparoscopic cholecystectomy (two stage approach) in patients with     combined cholelithiasis and choledocholithiasis.   "
197634|NCT00416247|"     This study is intended to investigate neurophysiological mechanisms of hypnosis using     transcranial magnetic stimulation (TMS) and assessment of motor cortex excitability in     healthy volunteers under hypnosis.   "
198005|NCT00439062|"     The purpose of this study is to evaluate the clinical efficacy, safety, and tolerability of     roxithromycin in patients with rheumatoid arthritis.   "
197635|NCT00416260|"     In the past five years, there is a growing body of published evidence on the feasibility, and     oxygenation and lung protection benefits of high frequency oscillation (HFO) in the acute     respiratory distress syndrome (ARDS). The investigators have recently demonstrated the short     term feasibility and additional benefits with respect to oxygenation of HFO combined with     tracheal gas insufflation (TGI). In the present clinical trial, the investigators intend to     test the hypothesis that HFO-TGI may result in improved respiratory physiology and clinical     course compared to low tidal volume conventional mechanical ventilation in patients with     severe ARDS.   "
197636|NCT00416273|"     The purpose of this study is determination of the event-free survival with and without     Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific     therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of     death.   "
197637|NCT00416286|"     The purpose of the study is to was to evaluate the anti bacterial efficacy of sustain-release     Cetylpyridinium chloride varnish on orthodontic patients.   "
197638|NCT00416299|"     To evaluate the use of new cardiac biomarker for the prediction of in-hospital cardiovascular     complications in elderly patients undergoing elective cardiac surgery.   "
197639|NCT00416312|"     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab and yttrium Y     90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them     without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.      PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I     131 tositumomab or yttrium Y 90 ibritumomab tiuxetan works in treating patients with     non-Hodgkin's lymphoma.   "
197640|NCT00416325|"     RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from     forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may     keep prostate cancer from forming in patients at high risk of developing prostate cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in     preventing prostate cancer in patients who are at high risk of developing prostate cancer.   "
197655|NCT00427284|"     The aim of the present study is to investigate wether endothelial dysfunction associated with     stable coronary artery disease is altered by selective aldosterone antagonism with Eplerenone     as potential anti-inflammatory drug versus placebo.      Additionally we hypothesize that selective aldosterone antagonism reduces systemic     inflammatory response such as C-reactive proteine, oxidative stress and pro-inflammatory     cytokines.   "
197656|NCT00434005|"     Objectives: This proposal addresses the overall hypothesis that ambient fine particulate     matter exerts cardiovascular health effects via alteration of endothelial homeostasis,     through a mechanism mediated by oxidative stress. This project will use a controlled human     inhalation exposure to diesel exhaust particulate (DEP) as a model to address the following     objectives: 1) Determine whether exposure to inhaled DEP is associated with endothelial     dysfunction in a concentration-related manner; 2) Determine whether exposure to inhaled DEP     is associated with evidence of systemic oxidative stress; and 3) Determine whether     antioxidant supplementation blunts the DEP effect on endothelial function.   "
201123|NCT00479570|"     The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on     acute sexual arousal and sexual interest in post menopausal females, as well as examining the     safety and toleration of the drug.   "
197641|NCT00416338|"     Peritoneal dialysis accounts for more than 70% of the dialysis modality in Hong Kong. Exit     site infection (ESI) is one of the causes leading to peritoneal catheter removal. Appropriate     exit-site care can prevent ESI. As the presence of a causative organism is essential in ESI,     eliminating organism invasion may be useful in preventing ESI. In the present study, an exit     site care method aiming at preventing organism invasion is developed to investigate its     effectiveness in reducing ESI. It is also hoped the present study can help to develop an exit     site care method that can reduce the frequency of exit site dressing so as to reduce the     burden of patients and to improve their quality of life.      We’ll recruit one hundred new chronic peritoneal dialysis patients into the study. The     patients will be divided into two groups. One group of the patients will use film-dressing     method (F) and the other group will use simple gauze dressing method (G). F group patients     will have the exit site covered with a dressing film and keep it intact for 7 days after     having the exit site cleaned with antiseptic solution. G group patients will clean the exit     site with antiseptic solution and change the simple gauze dressing daily.      The outcomes of the two groups will be compared. The outcome will be expressed in terms of     exit site infection free period, peritonitis free period and exit site condition     classification. Patient subjective quality of life will also be compared at first and twelfth     month.   "
197642|NCT00427115|"     Objective: To evaluate the feasibility and safety of a 4-6 weeks exercise -     psycho-educational intervention in patients undergoing allogeneic stem cell transplantation     (allo-HCST). The intervention included structured and supervised exercise, relaxation and     psycho-educational components. It was hypothesized that the intervention would minimize loss     of physical capacity during hospitalization.   "
197643|NCT00427128|"     This study randomized two stratifications of acute phase MDD SSRI responders, categorized as     having either true drug response or placebo response pattern, to continuation with SSRI     vs placebo in a double-blind trial to determine if stratification category predicted     continuation outcome.   "
197644|NCT00427141|"     Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in     animals affected the digestive system and blood cells. Study OPS106400 will be the first     administration of GSK580416 in humans. Parts A and B of this study will examine the safety,     tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to     placebo. Part C of the study will assess the effect of food on the safety, tolerability, and     pharmacokinetics of a single dose of GSK580416 in healthy subjects.   "
197645|NCT00427154|"     This trial is conducted in the United States of America (USA). This trial will compare the     changes in HbA1c after 26 weeks of inhaled insulin or rosiglitazone treatment, both in     combination with metformin and glimepiride.   "
197646|NCT00427167|"     This study will evaluate the safety and immune response of healthy volunteers to an     experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909.     Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that     is spread by certain kinds of mosquitoes. Each year, about 1 million people are killed by     malaria worldwide, most of them young children in Africa. AMA1 C1 may help block the malaria     parasite from getting into red blood cells. The vaccine is mixed with Alhydrogel® (Registered     Trademark), a material that is commonly added to vaccines to make them work better (also     called an adjuvant). Besides evaluating the vaccine, this study will also test two solutions     of an experimental adjuvant, CPG 7909-P and CPG 7909-S.      Healthy people between 18 and 50 years of age may be eligible for this 7-month study.     Participants are randomly assigned to one of four treatment groups (A, B, C or D below). All     receive two vaccinations, given as a shot in the upper arm either 1 or 2 months apart, as     shown:        -  Group A: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 28          (1-month interval)        -  Group B: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 28          (1-month interval)        -  Group C: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 56          (2-month interval)        -  Group D: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 56          (2-month interval)      Group A and B participants return to the clinic for checkups at 3, 7, and 14 days after each     vaccination and again at months 2, 3, 4, 5, and 7. Group C and D participants come to the     clinic at 3, 7, and 14 days after each vaccination and again at months 3, 4, 5, and 7.      In addition to the vaccinations, the study includes the following procedures:        -  Photographs of the subject's arm where the vaccination is given if a rash develops.        -  Daily temperature and symptoms record for the first 6 days after each of the 2          vaccinations, and at any other time there is concern about fever or other symptoms.        -  Blood draws about 12 times during the study to check for safety and to measure the          antibody response and the effect of the study vaccine.      Some participants may be asked to undergo plasmapheresis, a procedure for collecting plasma,     the liquid part of the blood. This is done by using a machine called a blood cell separator.     Blood is collected through a needle place...   "
197647|NCT00427180|"     Investigate whether blind subjects that fulfil the patient criteria provided with a Retinal     Implant are able to differentiate between simple patterns like horizontal bar, vertical bar     and cross.   "
197649|NCT00427206|"     The study objective was to determine if liver injury develops in alcoholic patients during or     following 5 days of therapeutic acetaminophen dosing. Volunteers were recruited from two     community detoxification centers to take either acetaminophen (4g/day) or placebo for 5     consecutive days. All subjects were monitored an additional two days following the dosing     period. The primary measures were aminotransferase measures taken at baseline and Days 2, 4,     6 and 7. We hypothesized that there would be no difference in aminotransferase means between     the groups at any study period.   "
197650|NCT00427219|"     This study will compare the efficacy and safety of ozarelix 15 mg. given IM 2 weeks apart on     the improvement of symptoms and the duration of improvement for up to 6 months in men with     BPH who are over 50 years of age.   "
197651|NCT00427232|"     Endothelin is a hormon that causes acute and chronic narrowing of heart vessels. The purpose     of this study is to assess whether suppression of this activity by using two types of     receptor antagonists can reduce this effect and thus improve blood supply of the heart     muscle.   "
197652|NCT00427245|"     RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for     breast cancer. It is not yet known whether goserelin is effective in preventing early     menopause in women undergoing chemotherapy for breast cancer.      PURPOSE: This randomized phase III trial is studying goserelin to see how well it works     compared with no goserelin in preventing early menopause in premenopausal women undergoing     chemotherapy for stage I, stage II, or stage III breast cancer.   "
197653|NCT00427258|"     Absorption, distribution, metabolism, and excretion (ADME) study with 14C in healthy young     men.   "
197654|NCT00427271|"     Research design: randomized, double-blind, placebo-controlled crossover study to evaluate the     putative interference of low-dose aspirin (for 8 weeks) on enalapril antiproteinuric     properties in microalbuminuric type 2 diabetes mellitus patients   "
197674|NCT00434239|"     This study is mainly assessing the safety of Revlimid in combination with Ancestim     (recombinant human stem cell factor) in patients with symptomatic myelodysplasia. Of those     two compounds, Revlimid has been shown to be an active drug in myelodysplasia. Clinical     responses will also be assessed.   "
197657|NCT00434018|"     We propose to test an evidence-based wheelchair skills training program to optimize     wheelchair safety and performance in veterans with SCI. The proposed training program     incorporates emerging evidence on wheelchair biomechanics and motor-skills learning, and     addresses recommendations in a new clinical practice guideline. Given the difficulty in     translating wheelchair skills learned in a therapy clinic with real world problems in the     home and community post-discharge, we are proposing to conduct the wheelchair skills training     in and around the veteran's home. The immediate goal is to enhance ability, performance time,     safety, community participation, and quality of life, while minimizing physical strain. The     ultimate goal is to reduce morbidity/mortality associated with wheelchair use and promote     successful aging with a disability.   "
197658|NCT00434031|"     The purpose of this study is to evaluate the rate of pathologic complete response when giving     docetaxel and trastuzumab followed by caelyx (liposomal doxorubicin), cyclophosphamide and     trastuzumab before surgery in treating women with operable or locally advanced HER-2 positive     breast cancer.   "
197659|NCT00434044|"     This study will represent the sponsor's first controlled study of etanercept in Chinese     subjects with Ankylosing Spondytitis (AS). This trial is designed to assess the safety and     efficacy of etanercept compared to placebo in the treatment of patients with AS.   "
197660|NCT00434057|"     The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that     uses machine vision for non-invasive early detection of cutaneous pigmented malignant     melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with     illumination in different spectral bands, from visible to near infrared, and automatically     analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will     be evaluated. The reference standard will be final interpretation of lesions by central     dermatohistopathology.   "
197661|NCT00434070|"     This study will examine whether HIV-infected patients are more likely to develop resistance     to antiretroviral therapy if their blood is not monitored for the number of viruses (viral     load) in the body.      A virus that changes (mutates) over time may become resistant to certain types of medicine.     This resistance may affect future treatment options. This study will compare the amount of     virus in the blood of HIV-infected patients who have been monitored for viral load with the     amount of virus in the blood of patients who have not been monitored for viral load. For     patients who have detectable virus, the type of resistance (mutations) of the virus will be     determined by comparing the components of the virus with that of a virus that is known not to     be resistant.      HIV-infected patients 18 years of age or older who are being treated at the Infectious     Diseases Institute at Mulago Hospital at Makerere University in Kampala, Uganda, may be     eligible for this study. Participants are interviewed about the treatments they have received     for HIV and how they usually take their anti-HIV drugs. They also have a blood sample drawn     for research tests.   "
197662|NCT00434083|"     -  to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate          85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine        -  to demonstrate the superiority of Trexima versus the individual components (sumatriptan          as the succinate 85 mg and naproxen sodium 500 mg), and        -  to evaluate the safety of the Trexima.   "
198006|NCT00439075|"     Evaluate efficacy and safety of CPAP in a randomised standard treatment controlled study, in     out-of-hospital patients with acute cardiogenic pulmonary edema.   "
197663|NCT00434096|"     The primary objective of this study is to assess the efficacy of SR141716 compared to placebo     on body weight and triglycerides changes over a period of 52 weeks.      Secondary objectives are:        -  To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on          HDL-cholesterol and visceral fat area.        -  To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks.        -  To evaluate the pharmacokinetics of SR141716.   "
197664|NCT00434109|"     The purpose of this study is to decide if a medicine that slows growth of new blood vessels     can be give after the embolization procedure to prevent or delay new growth of blood vessels     to tumors.   "
197665|NCT00434122|"     The main purpose of this clinical research study is to investigate if degarelix can     synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the     lining of the womb.   "
197666|NCT00434135|"     The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta     (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of     a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG     regimen) in terms of toxicity and QoL   "
197667|NCT00434148|"     This study will evaluate the safety and efficacy of two different doses of Pasireotide in     patients with de novo or recurrent/persistent Cushing's Disease.   "
197668|NCT00434161|"     The purpose of this study was to evaluate the efficacy and effect of palifermin on the     incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by     autologous peripheral blood stem cell transplantation. Amendment 01 (April 07) introduced     three cataract assessments to be carried out at Screening, Month 6 and Month 12 in response     to FDA and EMEA follow up measures.   "
197669|NCT00434174|"     This study will evaluate the safety of everolimus in combination with pemetrexed when used as     treatment in patients with non small cell lung cancer.   "
197670|NCT00434187|"     The primary objective is evaluate the safety, tolerability, and pharmacokinetics of multiple     doses of ERB-041, an investigational drug, in healthy, female Japanese subjects.   "
197671|NCT00434200|"     Aim of the study was to investigate the effectiveness (functional ability and physical     capacity) and safety (disease activity and damage of the joints) of long-term high-intensity     weight-bearing exercises in patients with rheumatoid arthritis (RA).The training proved to be     safe and effective.   "
197672|NCT00434213|"     This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit     the study site over a period of approximately 14 weeks.   "
197673|NCT00434226|"     This is a Phase II, randomized, controlled, open-label, multicenter trial designed to provide     a preliminary assessment of the safety and efficacy of sunitinib when combined with     carboplatin and paclitaxel chemotherapy and bevacizumab in patients with locally advanced,     recurrent or metastatic NSCLC who have not received prior systemic therapy for NSCLC. All     patients will have advanced, histologically or cytologically confirmed NSCLC (Stage IIIb with     pleural effusions, Stage IV, or recurrent).   "
197676|NCT00434265|"     Obesity is the consequence of a chronic disequilibrium of fat balance. Genetic factors     determine predisposition to obesity, but the most often mentioned idea is that environmental     factors, such as a high-fat diet and a sedentary lifestyle, join to favour weight gain and     explain the increased prevalence of obesity in our westernized societies. Since lipogenesis     is negligible in humans, obesity represents the consequence of altered fat partitioning     between oxidation and storage, likely due to a preferential directing of dietary fat towards     adipose tissue and away from muscle. Interventions that favour partitioning of dietary fat     towards muscle for oxidation might thus protect against weight gain. Exercise may be one kind     of such intervention but the scant data on dietary fat metabolism does not allow clear     conclusions, in particular in obese subjects. One question concerns the impact of the type of     fat eaten: the effects of physical inactivity may vary according to the length and saturation     degree of the fatty acids. We hypothesize that 1) physical activity of moderate intensity,     independently of its effect on energy balance, will favor a preferential trafficking towards     adipose tissue, will modify the expression of genes implicated in fat oxidation and storage     and partly correct the abnormalities observed in obese subjects, 2) effects of physical     activity vary according to the saturation degree of fat. Twelve obese subjects, aged 18 to     55, will undergo tests before and after 2 months of training at current recommendations to     ascertain dietary fat partitioning using stable isotopes and to determine changes in gene     expression with muscle and adipose tissue microbiopsies.   "
197677|NCT00434278|"     This was a multicenter, randomized, double-blind, placebo-controlled study of patients with     severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme.     Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks     (placebo group). Patients must have had stable CF symptoms without any change in therapy for     2 weeks prior to enrollment in order to participate.   "
197678|NCT00434291|"     This study will test the safety and efficacy of TG-873870(Nemonoxacin) compared with     Levofloxacin in adult patients with Community-Aquired Pneumonia(CAP)   "
197679|NCT00434304|"     This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in     Parkinson's Disease patients.   "
197680|NCT00434317|"     This study will evaluate the safety, tolerability and efficacy of zoledronic acid     administered intravenously every 3-4 weeks in patients with bone metastases from either     breast cancer or prostate cancer.   "
197681|NCT00434330|"     The purpose of this study was to determine the dose ranges of peginesatide administered     intravenously or subcutaneously that maintained hemoglobin in participants on dialysis whose     hemoglobin values were stable on epoetin (alfa or beta).   "
197682|NCT00434980|"     This is a pilot study evaluating the feasibility of a new family-based intervention for     schizophrenia. It is designed to help clients diagnosed with schizophrenia to overcome the     devastating effects of neurocognitive deficits on everyday functioning (Family-Directed     Cognitive Adaptation, FCA). Cognitive deficits in schizophrenia are known to contribute to     devastating functional impairments and caregiver burden, as clients rely on caregivers for     help with basic living needs, such as personal hygiene, time management, social skills, and     progress towards vocational and educational goals.      Specifically, we will 1) Develop a manualized, family treatment program designed to improve     adaptive functioning of patients with schizophrenia, and 2) Conduct a pilot feasibility study     to evaluate the acceptability and feasibility of this intervention, and to collect     preliminary outcome data. This will lay the foundation for a controlled trial of the efficacy     of the intervention. We expect that:        1. The FCA intervention will be well-received and well-tolerated by clients and families,          as demonstrated by a high level of interest in the program, a low rate of attrition, and          a high rate of participant satisfaction.        2. Client participants in the FCA intervention will show improvements in adaptive,          independent-living skills (e.g., personal hygiene and self-care, medication management,          time management, social skills, and responsibility for health maintenance) that will be          maintained three and six months following completion of the intervention.        3. Family members participating in the FCA program will show reduced burden of care and          time spent caregiving, greater satisfaction in their relationship with the client,          improved self-efficacy in the caregiver role, and reduced psychological distress (e.g.,          depression, anxiety, and hopelessness) at the completion of the program and at three and          six-month follow-up interviews.   "
197683|NCT00434993|"     Acute Respiratory Distress Syndrome (ARDS) and a lesser condition that occurs prior to ARDS,     Acute Lung Injury (ALI), are medical conditions that occur when there is severe inflammation     and increased fluids (edema) in both lungs, making it hard for the lungs to function     properly. Patients with these conditions require treatment that includes the use of a     breathing machine (ventilator). The purpose of this study is to find out whether giving     albuterol (a drug commonly used in asthmatics) or not giving albuterol to patients with ALI     or ARDS makes a difference in how long it takes for a patient to be able to breath without     the ventilator.   "
197684|NCT00435006|"     The purpose of this study is to assess the prevalence and predictors of pituitary     dysfunction, as well as secondary out-come in patients with traumatic brain injury or     spontaneous subarachnoidal haemorrhages.   "
197685|NCT00435019|"     This trial is conducted in Europe.      The aim of this research is to compare the efficacy and safety of treatment with NPH insulin     and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or     twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin   "
197686|NCT00435032|"     The purpose of this randomized trial is to compare two commonly utilized surgical treatments     for children with ruptured appendicitis: early appendectomy, versus interval appendectomy.     The primary outcome measure is time away from normal activities.   "
197687|NCT00435045|"     The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid     ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein     cholesterol (non-HDL-C) in hypertriglyceridemic subjects.   "
197688|NCT00435058|"     During the glaucomatous disease process, subpopulations of cells may be dead, damaged or     healthy. Visual function changes could be observed due to a recovering of the suffering     ganglion cells after the intraocular pressure reduction. This study aims at evaluating the     correlation between intraocular pressure reduction and visual function changes in glaucoma     patients after using antiglaucoma medications.   "
197689|NCT00435071|"     This study will investigate the postoperative recovery advantages from having a smaller     incision to a larger incision.   "
197719|NCT00435474|"     The purpose of this study is to investigate whether treatment for cancer patients with     malignant wounds can improve (wound healing/wound size, odor, infection, seepage, pain)     through comparing the effects of two multidimensional interventions including wound     treatment, psycho-social support and relaxation therapy.   "
197720|NCT00435487|"     To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients     of non ST elevation acute coronary syndromes who are planned to undergo coronary     interventions (angioplasty or bypass surgery)   "
197690|NCT00435084|"     This phase I/II study is designed to determine the safety and tolerability of APO866 for the     treatment of refractory B-CLL not amenable to aHSCT. APO866 has shown to induce growth     inhibition in cultures of a wide variety of human hematological malignant cells as well as in     models with subcutaneously implanted human tumors. APO866 was considered to be safe and     well-tolerated in a phase I study that treated 24 patients with advanced cancer. APO866 is     administered by intravenous infusion continuously for 96 hours and is repeated every 4 weeks.     In this study patients will receive only one cycle of treatment and the study endpoints will     be evaluated 4 weeks after the start of infusion. Patients will be followed up for 12 weeks     for safety.   "
197691|NCT00435097|"     The purpose of this protocol is to develop a detailed MRI technique and haemodynamic maps     enabling early detection of colorectal metastases in the liver.   "
197692|NCT00435110|"     Current American-European Consensus Conference (AECC) definitions for ALI and ARDS are     inadequate for inclusion into clinical trials due to the lack of standardization for     measuring the oxygenation defect. We questioned whether an early assessment of oxygenation on     specific ventilator settings would identify patients with established ARDS (persisting over     24h).   "
197693|NCT00435123|"     This is a long-term, randomized, placebo-controlled, double blind clinical study of a     nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition.     Subjects receive either ProStat 64 or Placebo for three months. At the end of this period,     all subjects will receive ProStat-64 for a further 3 months at which time the study is ended.     Parameters of nutritional status (lean body mass and serum protein) will be collected at     baseline, 3 months and 6 months.   "
197694|NCT00435149|"     This study will investigate the effect of one week of immobilization following carpal tunnel     release surgery versus no immobilization.   "
197695|NCT00435162|"     The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan     (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting     diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting     systolic blood pressure [SSBP] ≥ 95th percentile ).   "
197696|NCT00435175|"     Estradiol promotes and maintains the typical female phenotype characterized by subcutaneous     fat accumulation. There is evidence to suggest that this effect relies on the ability of     estradiol to increase the amount of anti-lipolytic α2A-adrenergic receptors, but whether this     requires long-term exposure to estradiol or is the result of an immediate effect is not     clear. Objective: To study acute effects of a single dose (4 mg) of 17β-estradiol on regional     and systemic lipolysis.   "
197697|NCT00435188|"     The purpose of this study is to determine whether a 12-month physical activity counseling     program, compared to usual care, improves physical performance in a sample of older veterans.     The primary physical performance outcome is change in gait speed.   "
197954|NCT00431288|"     The purpose of this study is to evaluate the efficacy of a 12-week, clinic-based, behavioral     nutrition intervention emphasizing fruits, vegetables, and low fat dairy compared to routine     nutrition care on changing dietary knowledge, self-efficacy, diet quality and blood pressure     post-treatment and at short-term follow-up in adolescents with hypertension.   "
197698|NCT00435201|"     The purpose of this study is to investigate the mechanism of autoantibody production during     chronic hepatitis C virus (HCV) infection. 10-50% of individuals with HCV have symptoms of     mixed cryoglobulinemia (MC). By studying the B cells from HCV-infected individuals with and     without MC, as well as from healthy controls, we hope to gain insight into the mechanisms of     autoantibody production and develop new strategies for treatment of MC.   "
197699|NCT00435214|"     Background:        -  In most women, HPV infection does not cause symptoms and the infection goes away on its          own. In a small percentage of women, the HPV infection does not go away and sometimes          can result in cervical precancer or cancer.        -  There are several different types of HPV. A better understanding of which types are          related to cervical precancer and cancer may help guide doctors in clinical management          of women who test positive for HPV and better understand why some women develop disease          while others do not.      Objectives:        -  To determine whether certain types of HPV are more risky than others and if so, whether          they warrant separate detection in screening for cervical precancer and cancer.        -  To determine if lasting infection by different HPV types carry different risk of          cervical precancer and cancer.        -  To determine what viral and genetic factors influence the development of cervical          precancer and cancer.        -  To evaluate new HPV tests and new biomarkers of cervical cancer risk.      Eligibility:      -Women 30 years of age and older who are in the cervical cancer screening program at the     Kaiser Permanente health plan in Northern California. Women who tested positive for HPV and a     random sample of women who tested negative for the virus are included.      Design:        -  Data about participants genetic background and the type of carcinogenic HPV with which          they are infected are analyzed.   "
197700|NCT00435227|"     -  The purpose of this study is to describe the effect of a single (IM) dose of motavizumab          in the upper respiratory tract in children who present with RSV illness but who do not          require hospitalization at the time of presentation and        -  Describe the effect of a single 30 mg/kg IM dose of motavizumab in decreasing the need          for hospitalization due to worsening RSV illness in children who receive outpatient          treatment        -  Describe the effect of a single 30 mg/kg IM dose of motavizumab on subsequent          respiratory status as measured by the Respiratory Assessment Change Score (RACS) and          change in oxygen saturation        -  For children who require hospitalization, describe the effect of motavizumab on severity          of RSV illness during hospitalization [i.e., RACS, oxygen saturation, heart rate, use of          supplemental oxygen, mechanical ventilation, and duration of intensive care unit (ICU)          stay]        -  Describe the effect of a single 30 mg/kg IM dose of motavizumab on duration of symptoms          of RSV illness (fever, coryza, cough, and parental opinion of return to normal health          and activity)        -  Describe the nasal concentration of motavizumab following a single 30mg/kg dose        -  Describe the serum pharmacokinetics and immunogenicity of a single 30 mg/kg IM dose of          motavizumab        -  Describe the effect of motavizumab on markers of inflammation as measured by gene          microarray and cytokine levels        -  Evaluate the safety and tolerability of a single 30 mg/kg IM dose of motavizumab in the          outpatient treatment of children with RSV        -  Describe the progression and severity of lower respiratory infection (LRI)   "
197701|NCT00435240|"     There is uncertainty about the optimal diet in the prevention and treatment of diabetes type     2. Earlier studies have generally focused on intakes of fat, protein, carbohydrate, fiber,     fruit and vegetables. This study is based on another approach which compares foods that were     available during human evolution with more recently introduced ones. The basic tenet from     evolutionary biology is that if human physiology is less adapted to a relatively recently     introduced diet based on agriculture, this could cause disturbances to human physiology and     ultimately lead to diseases. Epidemiological studies indicates that diabetes mellitus type 2     is absent or near absent in populations eating a Palaeolithic (Old Stone Age) diet which is     free from food items produced in agriculture or the food industry. Our study hypothesis is     that a Palaeolithic diet is better than the standard diabetes diet recommended today in     treating diabetes type 2.      Fifteen patients with diabetes type 2 have been randomized to        1. a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs,          and nuts        2. a standard diabetes diet as recommended by national health authorities.      The patients eat the diet they have been randomized to for three months and then switches to     the other diet for another three months. The study is conducted in Primary Health Care     stations.   "
197702|NCT00435253|"     Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8     subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.   "
197703|NCT00435266|"     Primary percutaneous coronary intervention (pPCI) is the preferred treatment in ST elevation     myocardial infarction (STEMI). The infarct-related artery (IRA) can be opened in more than     90% of the patients. However, STEMI patients still end up with a persistent perfusion defect     of highly variable magnitude indicating that adjunctive treatment may add further protection     against tissue damage. Ischemic preconditioning (IPC) is an intervention by which myocardium     threatened by ischemia is exposed to short and repeated sublethal ischemic episodes prior to     sustained ischemia (local IPC). A systemic response with protection of more remote organs     (remote IPC (rIPC)) also can be induced. We have recently found that the infarct reducing     effect can be obtained by obstruction of an extremity even though the remote stimulus is     initiated during sustained occlusion of a coronary artery, the so-called remote     preconditioning (rPerC). The clinical perspective is now to examine if rPerC can reduce the     infarct size in patients with unpredictable ischemia in ST elevation myocardial infarction     (STEMI). We perform a randomized study where patients en route for pPCI are allocated to     either rPerC or a standard treatment to evaluate whether the tissue damage can be reduced.     Effect measure will be infarct size determined by scintigraphy (final infarct size and     salvage).   "
197704|NCT00435279|"     To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects     receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).   "
197705|NCT00435292|"     Randomized, double-blind, placebo controlled parallel group, multi center study in subjects     with moderate-severe osteoarthritis.   "
197706|NCT00435305|"     The purpose of our study is to determine the penetration of continuously infused antibiotics     at steady state, mainly Meropenem, Vancomycin, Linezolid, Piperacillin/tazobactam and     additionally cefepim and ceftazidim, into epithelial lining fluid.   "
197708|NCT00435331|"     The purpose of this study is to determine whether the addition of sapropterin dihydrochloride     (6R-BH4) to existing treatment has any effect in patients with pulmonary arterial     hypertension (PAH). Patients with PAH have low levels of a substance called nitric oxide     (NO). Tetrahydrobiopterin (BH4) is a substance produced by the body that is an essential     requirement in the formation of NO. NO is thought to be helpful in keeping blood vessels in     the lung healthy. 6R-BH4 is an experimental (unproven) medicine made in the lab that is very     much like the BH4 that our own body makes. The researchers are investigating whether 6R-BH4     can be added safely to current treatment for PAH and whether there is any evidence of benefit     from its use. The study will take approximately one year to complete from the time     recruitment begins.      The primary objective of the study is to evaluate the safety of oral 6R-BH4, administered in     escalating doses in addition to standard care, in subjects with pulmonary arterial     hypertension (PAH).      The secondary objective of the study is to evaluate change in biochemical markers of     endothelial dysfunction and nitric oxide synthetase activity (coupled and uncoupled) in     subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care.      The third objective of the study is to evaluate change in biomarkers of disease progression,     6-minute walk (6MW) distance, Borg dyspnea scores, and quality of life (QOL) measures in     subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care.   "
197709|NCT00435344|"     The purpose of this study was to determine whether a pediatric practice-based smoking     prevention and cessation intervention increases abstinence rates among adolescents.   "
197710|NCT00435357|"     The purpose of the study is to analyse the clinical and radiological results of a     postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial     femorotibial arthritis will be included. The consequences on the patellofemoral joint will be     thoroughly analysed on skyline view.   "
197711|NCT00435370|"     This study will determine the effectiveness of tropisetron plus risperidone in improving     cognitive symptoms in Chinese people with schizophrenia.   "
197712|NCT00435383|"     To determine the which method of pain relief is better after current anesthesia care.   "
197713|NCT00435396|"     This will be the first time in humans (FTIH) study with the GSK Bio recombinant gB antigen to     evaluate safety and immunogenicity of this CMV candidate vaccine with a proprietary GSK     adjuvant system. The vaccine will be administered to young male healthy subjects at 0, 1 and     6 months. The trial will assess the safety and immunogenicity of the candidate CMV vaccine.     An additional secondary objective of this trial is to identify and validate a test which will     be able to differentiate between previous CMV infection and CMV vaccination. Subjects will be     followed for a total of 2 years.   "
197714|NCT00435409|"     The treatment received with sunitinib plus capecitabine could delay tumor growth longer than     with treatment with capecitabine alone.   "
197715|NCT00435422|"     The effect of individualized fluid optimization during neuroaxial blockade has not been     evaluated. The investigators evaluated if if Stroke decrease 15 min after activation of     neuroaxial blockade and whether SV could be optimized to pre activation values.   "
197726|NCT00435565|"     Background:      The risk of stillbirth and preterm delivery is three times increased among pregnant women     with type 1 diabetes compared with healthy pregnant women. Normal blood glucose levels are     mandatory in order to prevent these complications. Severe hypoglycemia (requiring assistance     from another person) is the decisive limiting factor for obtaining near-normal blood glucose     regulation in pregnant women with type 1 diabetes. Severe hypoglycemia occurs in about one     third of pregnancies complicated with type 1 diabetes and can result in unconsciousness,     traffic accidents and deaths.      Aim: To test the following hypotheses:        1. Severe hypoglycemia is frequent in pregnancy complicated by type 1 diabetes with the          highest incidence in gestational weeks 8-16 and the lowest incidence in gestational          weeks 28-34        2. Predictors for severe hypoglycemia during pregnancy complicated with type 1 diabetes can          be identified at the first pregnancy visit        3. Possible pathophysiological mechanisms include changes in the growth hormone system and          in the renin-angiotensin-system during pregnancy      Methodology:      One hundred and eight pregnant women with type 1 diabetes are consecutively and prospectively     included. In connection with the clinical control at the first pregnancy visit at week 9 and     in gestational weeks 14, 22, 28, 34 and one day postpartum the following tests are carried     out:      The patients are asked to answer a validated questionnaire about mild and severe hypoglycemia     and hypoglycemia-associated factors such as blood glucose level during hypoglycemia, the     degree of awareness, pregnancy-associated nausea and vomiting, insulin type and dose etc.     Other medication, exercise habits, coffee- and alcohol intake, smoking and social status will     be recorded. In case of severe hypoglycemia a structured interview concerning the episode     will be performed within 24 hours. Blood glucose, HbA1c, the degree of insulin resistance and     the levels of IGF1, placenta growth hormone and of the renin-angiotensin-system will be     monitored.   "
197727|NCT00435578|"     The primary objectives of this study are:        1. To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive          small cell lung cancer (SCLC) as measured by objective response rate        2. To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive          SCLC      The secondary objectives are:        1. To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive          SCLC as measured by duration of response, progression-free survival and overall survival        2. To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard (IPM)      The exploratory objectives of this trial are:        1. To evaluate the effect of glufosfamide on lung cancer symptoms        2. To evaluate the role of tumor cell glucose transporter expression on the efficacy of          glufosfamide   "
197728|NCT00435591|"     The study will evaluate the effectiveness and safety of multiple dosing regimens of IV     conivaptan in subjects with euvolemic or hypervolemic hyponatremia   "
197729|NCT00435604|"     This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study     comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC)     administered, viscous antibody solution of with and without human recombinant hyaluronidase     (rHuPH20) in volunteer subjects.      The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous     antibody with rHuPH20 will be comparable or shorter than the time required for the injection     without rHuPH20.   "
197730|NCT00435617|"     The primary aim of this study is to investigate the effectiveness of the use of a robotic     hand therapy device in the home environment. We hypothesize that the therapy group will     improve hand function more than a customary and usual care group.   "
197731|NCT00435630|"     The purpose of this study is to determine the learning curve for each of seven tasks in a     virtual reality laparoscopic simulator by medical students.   "
197732|NCT00435643|"     Context: Obstructive sleep apnea syndrome (OSAS) is associated with cardiovascular morbidity.     Recurrent episodes of occlusion of upper airways during sleep result in hormonal changes that     may predispose to high cardiovascular risk.These risks can rapidly be reduced by effective     nasal continuous positive airway pressure (nCPAP) therapy Objective: To evaluate hypothalamic     pituitary adrenal axis, insulin resistance, blood pressure values and adipokines in severe     obese patients with and without OSAS and to determine if continuous positive airway pressure     therapy (nCPAP) influenced responses.   "
197733|NCT00435656|"     In this research project, we will study the genetic determinants that influence the     pharmacokinetics of antiretroviral drugs used in the treatment of diseases caused by the HIV.   "
197734|NCT00435669|"     The purpose of this trial is to determine the mass balance, pharmacokinetics, metabolism, and     routes and extent of elimination of BMS-582664   "
197735|NCT00435682|"     This is a human trial to study the peripheral effect of therapeutic botulinum toxin     (botox-A). The trial is performed on healthy normal males. The study comprises of two     parallel placebo-controlled, double blinded studies.      In experiment 1 intramuscular Botox will be given in corrugator (one site) and frontalis (two     sites) muscles on one side and placebo to the other side. Intradermal (i.d.) capsaicin     injection will be given to both sides (between the two sites of frontalis injection     horizontally). Capsaicin-induced pain intensity and flare together with the area of     hypersensitivity to different stimulus modalities will be measured and mapped at specific     time points using different cutaneous stimuli (thermal, electrical, tactile, pressure). This     will characterize which fibres and receptors are affected by Botox and will show if Botox     have a unilateral effect (peripheral) or if it also affects the contralateral side (central     effect).      In experiment 2 intradermal Botox will be given in corrugator (one site) and frontalis (two     sites) muscles on one side and placebo to the other side. I.d. capsaicin injection will be     given to both sides (between the two sites of frontalis injection horizontally).     Capsaicin-induced pain intensity and flare together with the area of hypersensitivity to     different stimulus modalities will be measured and mapped at specific time points using     different cutaneous stimuli (thermal, electrical, tactile, pressure). This will characterize     which fibres and receptors are affected by Botox. The effect of intradermal Botox will be     compared to the results of experiment 1.      The two experiments will show if the intramuscular Botox exerts its action via a leak of     Botox from the muscle to the overlying skin.      Antipruritic effects of Botox on histamine prick test and itch will also be assessed in     parallel with the experiment 2. In this sub-experiment, 5 Units of Botox will be injected     intradermally in the middle of volar forearm. The same volume of placebo will be injected     into the other side. Histamine prick test will induce itch and the effect of intradermal     Botox will be assessed compared to the baseline. Flare area and visual analogue scale (VAS)     ratings will be measured.   "
197736|NCT00435695|"     The purpose of this study is to look at how much of a new drug, GSK163090, binds to proteins     in the brain and how much stays in the blood over a range of different doses. This study will     use a medical imaging technique called Positron Emission Tomography (PET) which uses an     imaging agent called [11C]-WAY100635.   "
197746|NCT00435825|"     This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks,     and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with     chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90     micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24     weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly     for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up     in all treatment groups for the primary endpoint. The anticipated time on study treatment is     3-12 months, and the target sample size is 500+ individuals.   "
197747|NCT00435838|"     This is a retrospective observational study which follows on from CNA106030 (a study     evaluating whether prospective genetic screening for HLA-B*5701 can reduce the incidence of     hypersensitivity reactions to abacavir). This study aims to collect data on approximately 35     subjects who withdrew from CNA106030 when found to be HLA-B*5701 positive. HIV disease     management and adverse event data in these subjects, where the risk/benefit ratio of     treatment with abacavir may alter subsequent prescribing, will be collected   "
197737|NCT00435708|"     Chronic obstructive pulmonary disease (COPD) is the UK's fastest growing fatal disease and is     estimated to cost the health service close to £1 billion every year. Around 80,000 people in     Northern Ireland suffer from COPD. COPD is clinically defined as a slowly progressive     condition characterised by airflow limitation, which is largely irreversible. Chronic     inflammation and oxidative stress are key components of the underlying pathological process     resulting in airflow limitation. Dietary factors and nutrients that have antioxidant or     anti-inflammatory properties are therefore of interest with respect to the aetiology of COPD.     The antioxidant vitamins C, E and beta-carotene are all present in the lung milieu. Such     antioxidants represent the lung's first line of defence against oxygen free radicals.     Observational studies indicate that a low dietary intake of antioxidant nutrients, or foods     rich in antioxidants (e.g. fruit and vegetables), is associated with decreased lung function     and increased risk of COPD. To date, there have been no food-based dietary interventions     investigating the effect of increased fruit and vegetable intake on COPD. The investigators     propose to recruit people with mild to moderate COPD and low fruit and vegetable intakes (<=2     portions daily) and randomise them to one of two study arms for 12 weeks - either to increase     fruit and vegetable consumption to at least 5 portions a day, or to follow their normal diet.     Airway and systemic oxidative stress and inflammation will be assessed at baseline and     post-intervention in order to determine if fruit and vegetables have the potential to     alleviate the oxidative stress and airway inflammation associated with COPD.   "
197749|NCT00435864|"     Numerous studies about the potential role of NK alloreactive during a n hematopoietic stem     cells graft are based on genotypical analyses of the KIR receptors and on genotypic     incompatibilities between KIR and HLA for couple donor/recipient. There is still a lot of     issues non resolved: Are KIR really expressed and how occur their expression during time when     hematopoietic reconstitution? Is it depending on HLA of the recipient?If KIR are expressed,     what are the mechanisms of alloreactivity of NK cells? Are NK able to lyse tumoral cells?     Could alloreactive NK cells constitute a therapeutic tool able to induce tolerance and     elimination of leukemia during hematopoietic stem cells grafts?   "
198007|NCT00439088|"     The purpose of this study is to compare the accuracies of the Patient Activity Monitor to     that of a standard pedometer during a walking task and some day-to-day activities in a     simulated apartment setting.   "
197738|NCT00435721|"     The current study aims to develop and evaluate a practical, short-term support and education     program for relatives of individuals with schizophrenia. This program has been developed to     maximize efficiency and effectiveness in the following ways:        1. The intervention specifically targets those factors empirically demonstrated to improve          family functioning and well being. Specifically, this pilot intervention aims to: a)          increase relatives’ knowledge about schizophrenia spectrum disorders; b) help families          attribute distressing behaviors of their ill relatives more accurately, by helping them          to distinguish behaviors that are directly related to the illness from personality          characteristics; c) improve attitudes towards the patient and reduce stress in          interactions with the patient; d) encourage problem-focused coping strategies; e) reduce          burden; f) provide opportunities for relatives to expand their social support network;          g) help families learn about and utilize community resources.        2. The program involves both individual and multifamily group components, in order to reap          the benefits of both formats. Specifically, multifamily psychoeducation groups          (involving individuals from several different families) tend to be more economical and          allow participants to learn from each other, increase their social support networks, and          reduce feelings of stigma. In contrast, individualized programs can target the specific          needs of participants.   "
197739|NCT00435734|"     The intervention program Obeldicks was developed for obese children aged 6 to 16 years.     This intervention is gender- and age specific. The 12-months intervention is based on     nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality     of structure, process and results of the intervention. Primary outcome measure is change of     weight status as standard deviation score of BMI. Furthermore, cardiovascular risk factor     profile, hormones (e.g. iGF-I, thyroid hormones, vitamin D status)adipocytokines, GI-     hormones, intima media thickness are measured prior to and after the one-year intervention.     The changes of these hormones and adipocytokines will allow to answer the questions whether     the alterations of these hormones are a cause or consequence of overweight. Additionally, a     genetic screening is performed to characterize the participants to probably predict response     to intervention.   "
197740|NCT00435747|"     The present study aims to compare the pre-emptive analgesic efficacy of parecoxib 40 mg IV/IM     versus placebo on reducing postoperative acute pain following submuscular breast     augmentation. Additionally this study is being conducted to evaluate the safety and     tolerability of parecoxib in this kind of procedure.   "
197741|NCT00435760|"     This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide     compared to placebo and tiotropium in patients with severe COPD after a single dose     treatment.   "
197742|NCT00435773|"     Previous studies have not addressed the question, whether or not a repeated leeching can     supply symptomatic relief of osteoarthritic pain for extended periods of time. We present a     randomized study to the effectiveness of single and repeated leech therapy in cases with     advanced osteoarthritis of the knee using a large patient group compared to a control group,     who were both blinded to the actual treatment modality.   "
197743|NCT00435786|"     In diabetic patients with end-stage renal disease to investigate the prevalence of diabetic     complications and quality of life and to compare with non-diabetic patients with ESRD and     diabetic patients with normal kidney function.   "
197744|NCT00435799|"     The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV     induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in     improving visual acuity. This is the first Norwegian study concerning CCL.   "
197772|NCT00436163|"     This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in     treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive     chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180     micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a     24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12     months, and the target sample size is less than 100 participants.   "
197748|NCT00435851|"     In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid     carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of     90-95% of patients. This favorable prognosis is the result of an effective primary therapy,     which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq     (100mCi) in case of significant risk of persistent disease. Few centers investigated the     possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential     long-term adverse complications for patients and to respond to radioprotection rules for     family members and medical staff.      Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid     hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of     hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge,     USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal     during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that     needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic     efficiency needs to be checked.   "
197802|NCT00436553|"     This study evaluated the effect of combination therapy with verteporfin photodynamic therapy     and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy     and the durability of response observed in patients with choroidal neovascularization     secondary to age-related macular degeneration.   "
197750|NCT00435877|"     This study will determine if bone marrow stromal cells can be used as a graft for     regeneration of bony defects. These cells have the ability to form new bone and to support     the formation of blood. Stromal cells have been identified in other tissues, such as the     dermis (underside of skin), spleen, thymus and fat, but it is not known whether these cells     can make bone and support blood formation as well as bone marrow stromal cells.      Patients undergoing surgery at Suburban Hospital in Bethesda, Maryland, in which some of the     bone, dermis, spleen, thymus or fat tissue is removed may be eligible for this study.      For this study, a small piece of the tissue that is removed during surgery for examination by     a pathologist will be used for research. Stromal cells from the specimen will be collected     and grown in the laboratory. The genes and proteins in the different cell types will be     compared, and the ability of stromal cells from the different tissues to make bone and to     support the formation of blood will be studied.   "
197751|NCT00435890|"     This randomized controlled trial will introduce a triage liaison physician (TLP) into the     University of Alberta Hospital Emergency Department (ED) and assess the influence on patients     who leave without being seen, ED length of stay, and other ED Overcrowding outcomes.   "
197752|NCT00435903|"     The goal of this open trial is to pilot the use of palm pilots as a tool for monitoring     smoking behavior in individuals with serious mental illness. That is, the investigators aim     to assess the usefulness and feasibility of using Palm Pilots as a tool for monitoring     smoking behavior and for coaching participants to use a strategy for delaying and reducing     cigarette use.   "
197753|NCT00435916|"     This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective     response rate and assess toxicity in patients with relapsed DLBCL.   "
197754|NCT00435929|"     This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics     of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir     1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly     with 2 to 3 active nucleoside reverse transcriptase inhibitors. The study will compare a     group of HIV patients without known liver disease and a group with moderate liver disease.     The anticipated time on study treatment is <3 months, and the target sample size is <100     individuals.   "
197755|NCT00435942|"     The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic     stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the     device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft)     through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in     subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair.   "
197756|NCT00435955|"     The purpose of this study is to determine whether an intensified treatment plus Rituximab     followed by autologous transplantation is superior to a conventional chemotherapy regimen     also supplemented with Rituximab.   "
197757|NCT00435968|"     Subjects will be asked to participate in a four day research study of the immune system     effects and safety of short-term acute dosing of Cold-fX.      The purpose of the study is to determine the effects of acute dosing of Cold-fX for 3 days on     the immune system compared to a placebo (dummy pill). Safety of the acute dosing will be     determined through various blood tests carried out during the study.   "
197758|NCT00435981|"     This is a randomized, placebo-controlled phase II study to investigate if a prime and boost     of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks     apart, is safe and can preserve beta cell function in children and adolescents with type 1     diabetes with a diabetes duration less than 18 months at intervention.   "
197759|NCT00435994|"     The purpose of this study is to evaluate how two different aerosol medications may improve     airway function in infants with respiratory illness. We are using two different medications     and comparing the difference in lung function after each medication. We will also be taking a     nasal wash sample for VEGF. We will be using this in comparing how infants respond to the     aerosol medications as well. We hope to help standardize medications used for infants with     bronchiolitis and RSV.   "
197760|NCT00436007|"     This study is being done to assess the possibility of the potential integration of malaria     vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and     immunogenic in infants aged 6 to 10 weeks at first dose, when co-administered with other EPI     vaccine antigens. The Protocol Posting has been updated in order to comply with the FDA     Amendment Act, Sep 2007.   "
197773|NCT00436176|"     The goal of this study is to investigate methods of improving diabetes care for African     Americans in primary care clinics. Primary care clinicians will receive training in the     delivery of cross-cultural medicine as well as regular performance feedback reports.   "
197855|NCT00437281|"     The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of     multiple doses of pregabalin in pediatric patients with partial onset seizures that are     incompletely controlled on their current medications.   "
197761|NCT00436020|"     Bipolar affective disorder (BPAD) is:        -  A serious mental illness        -  Estimated to be present in as high as 6.4% of the population in Western populations        -  Associated with considerable disability and high morbidity.        -  Characterized by periods of both lowered and elevated mood (i.e. depression and          mania/hypomania respectively).      The depressive aspect of bipolar disorder is often overlooked, possibly due to its less     dramatic nature, despite its significant impact on the lives of those affected. Bipolar     depression (BPAD-DP) is associated with a twenty fold increased risk of suicide, and     typically lasts three to five times as long as a manic or hypomanic episode. Despite this,     there has been relatively sparse investigation of treatments for BPAD-DP, with guidelines     based primarily on expert judgment rather than clinical trials. In addition a significant     proportion of patients with bipolar depression do not respond to the range of commonly used     medications. One of the only substantially new treatments developed for unipolar depression     in recent years has been the advent of repetitive transcranial magnetic stimulation (rTMS).     Repetitive TMS has been evaluated in over 20 trials conducted over the last ten years, but no     substantive trials have explored its use in bipolar depression. We propose to do this,     conducting a large scale clinical trial. The trial will include the assessment of both high     frequency left sided rTMS (as there is clearly the greatest evidence for the effectiveness of     this in unipolar depression) and low frequency right sided rTMS (as this there is growing     evidence of the effectiveness of this in unipolar depression and we have an excellent pilot     study to suggest its potential in BPAD-DP and it has never previously been assessed in a     clinical trial exclusively targeting this patient group). Our previous research strongly     supports the effectiveness of rTMS paradigms including low frequency right-sided stimulation     in unipolar depression and suggests these may have value in BPAD-DP. As BPAD-DP is clearly a     clinical problem of significant impact and with limited treatment options, there is a     pressing need for the development and definitive testing of novel treatments such as rTMS.   "
197762|NCT00436033|"     Investigation of efficacy and safety of treatment with milnacipran in the treatment of     fibromyalgia syndrome.   "
197815|NCT00436722|"     This is a randomized, controlled trial in liver transplantation in which conventional     immunosuppressive treatment will be compared with a therapeutic strategy consisting in     pre-transplant antibody-mediated T cell depletion followed by reduced calcineurin inhibitor     usage. The working hypothesis is that antibody induction followed by calcineurin inhibitor     minimization may promote development of tolerogenic mechanisms allowing the eventual     withdrawal of all immunosuppressive therapy.   "
197763|NCT00436046|"     Influenza is a virus infection that causes sickness from the nose to the lungs. It is thought     that type 1 interferon (a protein that helps the immune system fight viruses) will make flu     vaccines more effective. This study will determine if type 1 interferon added to a specific     flu vaccine will help the immune system of healthy adults fight off infection better than     vaccine alone. Ninety volunteers, ages 18-40, will participate in this study. They will     attend 3 study visits and have a final follow-up study visit, email, or phone call about six     months after the vaccination. Volunteers will receive a single dose of study vaccine sprayed     into the nose. Study procedures including blood samples and nasal washes (the inside of the     nose is washed out) will be collected to evaluate immune system responses.   "
197764|NCT00436059|"     The primary objective of the the study is to investigate the changes in bone remodeling     during Velcade treatment.   "
197765|NCT00436072|"     This research study will test the safety of the investigational drug, ZD6474, in combination     with 2 other drugs that are standard in the treatment of colon and rectal cancer (cetuximab     and irinotecan). ZD6474 blocks the action of two substances in the body: vascular endothelial     growth factor receptor (VEGFR) and epidermal growth factor receptor (EGFR). VEGFR stimulates     the formation of new blood vessels. When cancer cells produce VEGFR, new blood vessels are     made that provide blood to the cancer cells. The blood carries nutrients and oxygen, allowing     the cancer cells to live and grow. EGFR controls how quickly cells grow and multiply. Both of     these substances are found on normal cells, but they are found in much higher levels on     cancer cells.   "
197766|NCT00436085|"     The introduction of highly active antiretroviral therapy (HAART) has dramatically changed the     consequences of an HIV infection, which is now viewed as a chronic disease. As in other     chronic diseases, emotional distress and depressive symptoms are highly prevalent in     HIV-infected patients. Psychological factors such as these have been associated with lower     quality of life, lower adherence to therapy and also with a higher risk for mortality and     disease progression. Psychosocial interventions, such as group-based cognitive behavioral     stress management (CBSM) training, have been shown to reduce distress and psychological     symptoms in HIV-infected patients. These psychosocial effects are paralleled by changes in     physiological parameters, such as cortisol, DHEA-S, testosterones, catecholamines, and naïve     T-cell counts. While these results are congruent with recent evidence of the interaction     between psychological, neuroendocrine and immunological parameters in HIV-infected patients,     it needs to be shown whether the reported effects hold true in the HAART era. Most     importantly, it also needs to be ascertained whether these interventions have an impact on     immunological and virological HIV parameters as well as on mortality and morbidity in HIV     patients. We propose a randomized controlled one-year prospective evaluation of a group-based     CBSM training in 80 HIV-infected patients. Participating patients will be recruited at     cooperating centers of the Swiss HIV Cohort Study and randomly assigned to CBSM training or     waiting control group condition. At baseline, post-training and two follow-up (6 and 12     months) assessments, effects of the CBSM on psychological, physiological and clinical     out-come variables in HIV-infected patients under HAART will be evaluated. Additionally, the     effects of CBSM on the neuroendocrine and autonomic stress reactivity in HIV-infected     patients will be assessed, thus evaluating a possible direct pathway between emotional     distress and physiological HIV-relevant parameters. In conclusion, the planned research     project evaluates the effectiveness of a standardized psychosocial intervention as a possible     component of a comprehensive disease management in HIV-infected patients under HAART.   "
197767|NCT00436098|"     Children with congenital heart defects have shown to develop motor coordinative deficiencies.     In this study we want to show that a motor pedagogic physical training can improve the     coordinative capabilities of children aged 4-6 years.   "
197768|NCT00436111|"     The purpose of this study is to clarify the nature of macroprolactin which has recently been     highlighted because of the high prevalence and a diagnostic pitfall of hyperprolactinemia.     The results of this study are beneficial for the patients to whom unnecessary medications and     unnecessary radiological examinations have been performed.      We used the remained serum samples taken for routine prolactin determination during the past     several years. Since the blood was basically taken to examine the causes of     hyperprolactinemia and only remained serum samples were used for this study, the Ethics     Committee of Kobe City General Hospital judged that it was not required to obtain approval     number.   "
197769|NCT00436124|"     This study will evaluate the efficacy and safety of Tamiflu in patients with     clinically-diagnosed influenza occurring during an influenza outbreak within the community.     Patients will be randomized to receive Tamiflu 75mg bid orally plus support therapy (NSAIDs     and antibiotics) or support therapy alone. The anticipated time on study treatment is <3     months, and the target sample size is <100 individuals.   "
197770|NCT00436137|"     The purpose of this study is to determine whether direct mailings to patients with positive     fecal occult blood tests can increase rates of performing followup colonoscopy.   "
197771|NCT00436150|"     This study will aim to prevent postpartum depression in pregnant teenagers through an     interpersonal therapy-based program.   "
197812|NCT00436683|"     Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food,     reducing the amount that the body can absorb.      The purpose of this study is to determine how well a range of different doses of fermagate     are tolerated by the subjects in the trial.   "
197774|NCT00436189|"     Purpose      The OvaRI assay clinical trial is directed at evaluating a novel proteomics-based blood test.     This test is for a physician to use towards differentiating benign from malignant ovarian     tumors prior to surgical intervention. Tools that can better triage women with an ovarian     tumor are needed. It has been shown that women with ovarian cancer who are referred to     gynecologic oncologists have better outcomes. The primary objective of this study is to     demonstrate that the OvaRl assay (test) improves the preoperative identification of ovarian     cancer in patients with a ovarian tumor.   "
197775|NCT00436202|"     The purpose of the study is to determine whether improvement in the accessibility to iron     supplement will decrease anemia rates in infants.   "
197837|NCT00437034|"     This phase II trial is studying the side effects and how well aflibercept works in treating     patients with stage II or stage III multiple myeloma that has relapsed or not responded to     previous treatment. Aflibercept may be able to carry cancer-killing substances directly to     multiple myeloma cells. It may also stop the growth of multiple myeloma by blocking blood     flow to the cancer.   "
197838|NCT00437060|"     This clinical trial is looking at brain function in young patients receiving methotrexate for     acute lymphoblastic leukemia. Learning about the long-term effects of methotrexate on brain     function may help doctors plan cancer treatment.   "
197776|NCT00436215|"     Background:        -  Sorafenib and bevacizumab are anti-cancer drugs that work by targeting the blood vessels          that allow tumors to grow. Using the two drugs together may more effectively block the          formation of blood vessels that feed tumors.        -  Sorafenib and bevacizumab both are approved by the Food and Drug Administration for use          in other cancers but have not ovarian cancer. In a preliminary trial of this drug          combination, however, tumors in 6 of 14 patients with ovarian cancer shrank.      Objectives:        -  To determine the safety and activity of the combination of sorafenib and bevacizumab for          treating patients with ovarian, fallopian and peritoneal cancer.        -  To determine how sorafenib and bevacizumab may affect the cancer by measuring amounts of          different proteins in small biopsy samples of tumor taken before starting treatment and          after 6 weeks.      Eligibility:        -  Females 18 years of age and older with ovarian, fallopian, or peritoneal cancer whose          disease has not responded to standard treatment or for which no standard treatment is          available.        -  Patients must have not been previously treated with bevacizumab or must have had their          disease worsen while taking bevacizumab-based therapy.      Design:        -  Patients take 200 mg of sorafenib by mouth twice a day Monday through Friday each week          and 5 mg/kg of bevacizumab through a vein every 2 weeks.        -  Tumor biopsies and imaging scans (magnetic resonance imaging (MRI) and positron emission          tomography (PET) are done before treatment, 3 days after beginning treatment, and 6          weeks into therapy.        -  Computed tomography (CT) or other imaging tests are done every 8 weeks to evaluate          response to treatment.        -  History, physical examinations, blood and urine tests are done periodically during          treatment for health checks and research purposes.        -  About 74 patients are to be enrolled in the trial.   "
197777|NCT00436228|"     SB-742510 is a semi-synthetic pleuromutilin antibiotic that is being developed for treatment     of respiratory infections.      The purpose of this study is to estimate the bioavailability of four different formulations     and to evaluate the safety of each of the four formulations   "
197778|NCT00436241|"     This single arm study will assess the efficacy and safety of Xeloda in combination with     oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric     cancer who have had no prior chemotherapy for advanced or metastatic disease. Eligible     patients will receive Xeloda 1000mg/m2 po twice daily, D1-D10 every 2 weeks (10 days     treatment followed by 4 days rest period) plus oxaliplatin 85 mg/m2/day iv, D1 every 2 weeks.     The anticipated time on study treatment is until disease progression, and the target sample     size is <100 individuals.   "
197779|NCT00436254|"     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.     Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in     bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an     effective treatment for breast cancer and ovarian cancer. PURPOSE: This phase I trial is     studying the side effects and identifying the best dose of vaccine therapy when given     together with sargramostim in treating patients with stage III-IV breast cancer or ovarian     cancer.   "
197780|NCT00436267|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in     chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving radiation therapy in     different ways and giving it together with chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving internal     radiation therapy and external radiation therapy together with fluorouracil works in treating     patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot     be removed by surgery.   "
197781|NCT00436280|"     The primary purpose of this study is to help answer the following research questions:        -  To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin          (R-GEMOX) can help patients with Diffuse Large B-Cell Lymphoma remain free from disease          and thus live longer.        -  To assess for any side effects that might be associated with enzastaurin and R-GEMOX .        -  To look at the characteristics and levels of certain genes and proteins to learn more          about DLBCL and how enzastaurin works in the body.        -  To look at the level of enzastaurin in the body and how long it remains.   "
197782|NCT00436293|"     Primary objective:      To assess and compare the toxicities of patients with advanced NPC treated with concurrent     cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin.      Secondary objective:      To assess tumor control and survival   "
197783|NCT00436306|"     The primary purpose of Project PROTECT was to evaluate two different intervention approaches     that encourage young women to use dual methods of contraception. The individualized     intervention is a computer assisted, fully-tailored, interactive intervention based on the     transtheoretical model of behavior change. This intervention was compared to an enhanced     standard care intervention that provided computer-based, non-tailored information and advice     regarding the use of contraceptive methods. The two primary outcomes of this trial include:     1) a behavioral outcome: the reported use of dual methods of contraception; and 2) a     biological outcome: an incident or recurrent STI or unintended pregnancy. The hypotheses of     this trial were: 1) the individualized intervention will result in a greater increase in dual     contraceptive use than the standard care approach; and 2) the individualized intervention     would result in greater protection against incident or recurrent cases of sexually     transmitted infections and unplanned pregnancies.   "
197784|NCT00436319|"     The purpose of this study is to assess whether the probability of pregnancy is dependent on     the duration of GnRH agonist downregulation in IVF cycles.   "
197785|NCT00436332|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with     bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab     works in treating patients with stage III or stage IV non-small cell lung cancer.   "
197786|NCT00436345|"     This study will be a multicentre randomized, open-label, phase IIIb study. This study will     evaluate two different techniques of sedation: an analgesia based regimen with remifentanil     versus a conventional sedation based regimen using propofol in subjects that require     mechanical ventilation for at least 2 days in the ICU. The conventional sedation based     regimen will consist of propofol combined with an opioid according to routine clinical     practice (morphine, fentanyl, sufentanil or other as required) . The analgesia based regimen     will consist of remifentanil, with propofol added on if required.   "
197894|NCT00430508|"     The study will evaluate the blood pressure lowering effects of two different dosages of the     combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high     blood pressure.   "
197787|NCT00436358|"     This is an epidemiology study designed to implement hospital-based active surveillance for     intussusception (IS) in children <1 year of age and lower respiratory tract infection     (LRTI)-related deaths among children between 29 days and 1 year of age in Mexico. An existing     linked database of the Instituto Mexicano del Seguro Social (IMSS) will be used. The study     described in this protocol is a pilot study, which will evaluate the methodology to be used     in a later Post-Marketing Surveillance (PMS) study.      The planned epidemiology study will be conducted in IMSS hospitals and potentially use the     IMSS database to re-capture potential cases of IS and fatal cases and as a source of matched     case controls. The purpose of this project is to complement this data link system with an     active surveillance system for IS - in order to assess the feasibility of using the IMSS data     system by generating results that provide scientific validity. Such comprehensive (passive     and active) surveillance systems will facilitate the post licensure safety profile evaluation     of vaccines such as a vaccine against rotavirus diarrhoea.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
197788|NCT00436371|"     To collect the safety and response of using Amisulpride in acute schizophrenic patients   "
197789|NCT00436384|"     Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a     transplant. Serious infections due to CMV can affect many parts of the body including the     lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have     evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or     valganciclovir). Despite this, there are a chance that CMV infection may cause problems in     the future. The purpose of this study is to assess how well patients'immune systems responds     to the CMV virus, so that in the future it may be possible to predict which patients are at     highest risk of CMV.   "
197790|NCT00436397|"     RATIONALE: A new radiation therapy planning system may help doctors plan better treatment for     patients with cancer.      PURPOSE: This clinical trial is studying a new radiation therapy planning system in patients     undergoing radiation therapy for extracranial cancer.   "
197791|NCT00436410|"     RATIONALE: Biological therapies, such as tumor necrosis factor, may stimulate the immune     system in different ways and stop tumor cells from growing. Studying tumor necrosis factor in     samples of tumor tissue and healthy tissue from patients with cancer in the laboratory may     help doctors learn how tumor necrosis factor works in tumor tissue and healthy tissue.      PURPOSE: This clinical trial is studying tumor necrosis factor in patients undergoing surgery     for primary cancer or metastatic cancer .   "
197792|NCT00436423|"     The primary objective of the study is to Evaluate the response rate of Gemcitabine with TS-1     in Korean patient with advanced but inoperable, metastatic or recurrent pancreatic cancer who     is not receiving anti cancer therapy.   "
197793|NCT00436436|"     RATIONALE: Drugs used in chemotherapy, such as O(6)-benzylguanine and temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells.      PURPOSE: This phase II trial is studying the side effects and how well giving     O(6)-benzylguanine together with temozolomide works in treating patients with glioblastoma     multiforme that did not respond to previous temozolomide and radiation therapy.   "
197794|NCT00436449|"     This will be a multi-centre, double-blind, within-subject, placebo controlled randomised     trial in female subjects. All subjects will undergo bilateral breast augmentation surgery.     Immediately following surgery, each subject will receive 100µl containing 50ng or 200ng of     RN1001 per linear centimetre intradermally into both margins of one breast wound, and 100µl     of placebo solution per linear centimetre intradermally into both margins of their other     breast wound. The allocation of treatment to wound (left or right) will be randomised and     double blind.   "
197795|NCT00436462|"     Expression of steroid receptors in endometrium during ovarian stimulation.   "
197796|NCT00436475|"     The purpose of the randomized trial is to quantify the effect of vitamin D and calcium     supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic     inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2     diabetes.   "
197797|NCT00436488|"     The genetic contribution to the development of obesity is now well recognized. However     obesity is a polygenic disease and thus many genes are likely to be involved. This study aims     to investigate the possible association between specific variants of the gene coding for the     Intercellular Adhesion Molecule-1 (ICAM-1)and the development of severe obesity in an Italian     population   "
197813|NCT00436696|"     RATIONALE: Identifying genes related to cancer may help in the study of cancer. It may also     help doctors predict who is at risk of developing neuroblastoma.      PURPOSE: This laboratory study is looking at genes in participants with neuroblastoma or     noncancerous conditions.   "
201124|NCT00479583|"     The purpose of this research study is to determine the highest dose of BMS-690514 that can be     safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to     patients with advanced cancer   "
197798|NCT00436501|"     This phase I/II trial is studying the side effects and best dose of VEGF Trap when given     together with docetaxel and to see how well they work in treating patients with persistent or     recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.     VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used     in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving VEGF Trap together with     docetaxel may kill more tumor cells   "
197799|NCT00436514|"     Colorectal cancer is one of the most frequent and it prognosis is still serious. In France,     diagnosis and screening applicated in numerous departements, and now in a path of     generalization to the all country, is based on combination of searching blood into bowel     movements (Haemoccult) for the screening of population with medium risk (age between 50 to 74     years old)and colonoscopy for the screening and diagnosis of pre-cancerous lesions for the     patients with a high risk.Even if the efficiency of this strategy is proved, searching blood     into the bowel movement by Haemoccult is still imperfect (a lot of false negative).     Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and     it constitute an invasive method, with complications, with a compulsory general anesthesia,     implicating a high cost. The alternative of a screening method based on a non invasive method     is required.   "
197800|NCT00436527|"     This eight-hour kinetic regression clinical study was conducted to assess the ability of     MetroGel® 1% to deliver moisture to facial skin after a single application.   "
197801|NCT00436540|"     The primary objective of this study is to evaluate the efficacy and safety of clobetasol     propionate 0.05% (Clobex®) spray compared to clobetasol propionate 0.05% (Olux®) foam.   "
197803|NCT00436566|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     combination chemotherapy together with trastuzumab and lapatinib after surgery may kill any     tumor cells that remain after surgery.      PURPOSE: This randomized phase II trial is studying the side effects and how well giving     doxorubicin together with cyclophosphamide followed by trastuzumab, paclitaxel, and lapatinib     works in treating patients with early-stage HER2-positive breast cancer that has been removed     by surgery.   "
197804|NCT00436579|"     This randomized phase I trial is studying the side effects, such as high blood pressure, and     best dose of sorafenib in treating patients with advanced solid tumors. Sorafenib may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth and by     blocking blood flow to the tumor.   "
197805|NCT00436592|"     The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter     in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours     prior to treatment. The NeuroFlo device is intended to increase blood flow to the brain and     potentially reduce the damage caused by stroke.   "
197806|NCT00436605|"     This phase II trial is studying how well dasatinib works in treating patients with stage III     melanoma that cannot be removed by surgery or stage IV melanoma. Dasatinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
197807|NCT00436618|"     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the cancer.      PURPOSE: This phase II trial is studying the side effects and how well everolimus works in     treating patients with lymphoma that has relapsed or not responded to previous treatment.   "
197808|NCT00436631|"     This is a prospective, open-label (no control or blind) study to continue to determine     whether the modified Atkins diet reduces seizures, creates ketosis, and is well tolerated in     adults (not children) with epilepsy. This study will enroll and manage patients via email,     phone, and fax and without dietitian involvement (primary difference from previous studies).     It is a 3 month study.   "
197809|NCT00436644|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as topotecan, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving lapatinib together with topotecan may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving lapatinib together with topotecan     works in treating patients with ovarian epithelial cancer or primary peritoneal cancer that     did not respond to cisplatin or carboplatin.   "
197810|NCT00436657|"     There has been no successful treatment of diffuse peritoneal metastasis or carcinomatosis, in     childhood tumors. Once this advanced stage of disease is evident, survival is measured in     weeks. The selective lethal effect of supranormal temperatures on neoplastic cells and the     additive or synergistic effect of combining chemotherapy has been well established in adult     clinical trials using continuous hyperthermic peritoneal perfusion (CHPP) for advanced     peritoneal adenocarcinoma of gastrointestinal origin, ovarian carcinoma and mesothelioma.      This phase I study will evaluate the safety of continuous hyperthermic peritoneal perfusion     with escalating doses of intraperitoneal cisplatin in the treatment of children with     refractory tumors limited to the abdominal cavity. If tumors are outside the abdominal     cavity, the tumors must be able to be controlled.      Since CHPP has potential to improve outcome of children with peritoneal and retroperitoneal     metastases, this study will evaluate the safety of elevated temperature (40oC) with     intraperitoneal cisplatin chemotherapy.      Primary Objectives:        1. To determine the MTD and dose-limiting toxicity of intraperitoneal cisplatin given in          combination with CHPP as a 90 minute perfusion in children with advanced peritoneal and          retroperitoneal solid tumors        2. To determine the safe and tolerable dose of CHPP with cisplatin to be used in Phase II          trials        3. To determine the pharmacokinetics of intraperitoneal cisplatin platinum given with CHPP          as a 90 minute abdominal perfusion (Optional)   "
197811|NCT00436670|"     A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317     compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom     scores from baseline to week 12.   "
197814|NCT00436709|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of breast cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such     as doxorubicin, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving bevacizumab together with chemotherapy after surgery may     kill any tumor cells that remain after surgery.      PURPOSE: This clinical trial is studying the side effects and how well giving bevacizumab     together with doxorubicin and cyclophosphamide followed by paclitaxel albumin-stabilized     nanoparticle formulation and bevacizumab works in treating patients who have undergone     surgery for early-stage breast cancer.   "
197895|NCT00430521|"     The aim of the study is to assess the safety & immunogenicity of a pandemic influenza vaccine     administered at 2 different time points. The Protocol Posting has been updated in order to     comply with the FDA Amendment Act, Sep 2007.   "
197816|NCT00436748|"     The primary objectives of this study are the following:        1. To test if the proportion of participants achieving a hemoglobin value greater than or          equal to 10.0 g/dL at any time point after the first dose during the study is greater          than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of          anemia in pediatric patients with chronic kidney disease receiving and not receiving          dialysis, and        2. To test if the proportion of participants achieving a hemoglobin value greater than or          equal to 10.0 g/dL at any time point after the first dose during the study is greater          than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of          anemia in pediatric patients with chronic kidney disease receiving and not receiving          dialysis.   "
197817|NCT00436761|"     RATIONALE: Giving chemotherapy before a donor umbilical cord blood stem cell transplant helps     stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting     the donor's stem cells when they do not exactly match the patient's blood. The donated stem     cells may replace the patient's immune cells and help destroy any remaining tumor cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving cyclosporine and methylprednisolone     after the transplant may stop this from happening.      PURPOSE: This phase I trial is studying the side effects of busulfan, melphalan, and     antithymocyte globulin followed by umbilical cord blood transplant in treating young patients     with refractory or relapsed malignant solid tumors.   "
197818|NCT00436774|"     RATIONALE: Treatment for pediatric extracranial germ cell tumors may cause side effects and     secondary cancers later in life. A study that evaluates patients after receiving combination     chemotherapy or surgery may help doctors understand the side effects and secondary cancers     that occur later in life.      PURPOSE: This study is looking at treatment outcome and quality of life in patients with     pediatric extracranial germ cell tumors previously treated on clinical trial CCLG-GC-1979-01     or CCLG-GC-1989-01.   "
197819|NCT00436787|"     Morbidly obese individuals are at high risk for potentially life threatening blood clots     around the time of abdominal surgical procedures. Fondaparinux sodium (Arixtra) is an FDA-     approved medication used in the prevention of deep venous thrombosis (DVT) at the time of     orthopedic or abdominal surgery, as well as for the treatment of DVT and pulmonary embolism     (PE). As with many medications, therapeutic dosages have not been fully investigated for the     morbidly obese population. Our goal is to study the therapeutic blood levels, after 2     different dosages of the medication are given to morbidly obese volunteers. We will recruit     21 morbidly obese (Body Mass Index (BMI) > 35) individuals who are in the evaluation process     for bariatric surgery. They will be divided into 7 groups: 3 participants with BMI 35 - 39.9,     3 with a BMI of 40 - 49.9, 3 with a BMI of 50 - 59.9, 3 with a BMI > 60, 3 with a weight of     100 - 149 KG, 3 with a weight of 150 - 199 KG and 3 with a weight of 200 - 249 KG.     Participants will be administered two different doses of the medication with a 2-week     interval in between, then blood will be drawn in various intervals throughout the next 48     hours to see which dose provides the best therapeutic levels. Participants will be monitored     closely for any side effects or complications.   "
197820|NCT00436800|"     Primary objective:      To evaluate the response rate of biweekly gemcitabine and oxaliplatin (the GEMOX regimen) in     the first line treatment of metastatic or recurrent nasopharyngeal carcinoma.      Secondary objectives:      To assess the toxicity, duration of response, time to progression, progression-free survival,     overall survival and cancer-related symptoms in the first line treatment of patients with     metastatic or recurrent NPC.   "
197821|NCT00436826|"     The goal of this study is to evaluate the safety, tolerability and effectiveness of oral     cladribine when taken in combination with Interferon-beta (IFN-beta) therapy for the     treatment of multiple sclerosis (MS).      This study will randomize around 200 subjects from approximately 50 sites located world-wide,     who have experienced at least one relapse while taking IFN-beta therapy within 48 weeks prior     to Screening, irrespective of disability progression. Secondary progressive multiple     sclerosis (SPMS) subjects, who are still experiencing relapses, and subjects who have     received disease modifying drugs (DMDs), other than IFN-beta therapy, during their MS     treatment history, but are currently on IFN-beta therapy and have experienced active MS     symptoms (at least 1 relapse) during the 48 weeks prior to Screening, may also be enrolled.      Subjects will be randomized in a 2:1 fashion to receive up to 4 cycles of oral cladribine or     matching placebo in combination with IFN-beta therapy. Subjects who complete the double-blind     portion of the study will be invited to participate in an open-label extension phase of     matching study design. Total participation is 96 weeks in double blind period, and up to 48     weeks in open label extension phase.   "
197822|NCT00436839|"     To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and     prednisone in subjects with hormone-refractory metastatic prostate cancer.   "
197823|NCT00436852|"     This phase II trial is studying how well ABT-751 works in treating children with     neuroblastoma that has relapsed or not responded to previous treatment. Drugs used in     chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing.   "
197824|NCT00436865|"     The polycystic ovary syndrome is the leading cause of female infertility in the United     States. The disorder affects approximately 6-10% of women of reproductive age. It is widely     accepted that insulin resistance may be responsible for the infertility of this syndrome.     Women are insulin resistant when their bodies do not respond to insulin's action to handle     sugar as they normally should. Because of this insulin resistance, women with the polycystic     ovary syndrome are also at high risk for developing type 2 diabetes. We have previously shown     that D-chiro-inositol (DCI), a substance naturally found in our body that helps insulin's     action, is lacking in women with the polycystic ovary syndrome. Not having enough DCI may     lead to insulin resistance. The purpose of this study is to determine if weight loss helps to     replenish the body with DCI and help to promote insulin's action.   "
197896|NCT00430534|"     To evaluate the safety, immune-response and efficacy of GSK Biologicals’ EBV vaccine in a     population at risk of developing infectious mononucleosis. Each subject will receive three     doses of vaccine or placebo during the study period.   "
198032|NCT00439413|"     The purpose of this study is designed to examine the effects of Selegiline Transdermal System     and behavioral intervention in smoking cessation as compared to behavioral intervention     alone.   "
197825|NCT00436878|"     The purpose of this study is to test the effects of large food portions on children's eating.     Experiment 1 will test the effect of portion size on children's consumption of sweetened     beverages; we hypothesize that serving large beverage portions will increase the amount of     energy children consume from this food. Experiment 2 will test the effects of portion size on     children's intake of fruits and vegetables (FV) affect intake whether such effects are     moderated by children's FV preferences and; we hypothesize that serving large fruit and     vegetable portions will produce increases in children's intake of these foods, particularly     for children who like fruit and vegetables. Experiment 3 will evaluate how food energy     density affects children's response to large portions; we hypothesize that large portions     will have the greatest influence on children's energy consumption when foods are energy     dense. Experiment 4 will begin to address perceptual mechanisms by which large portions     affect children's eating.   "
197826|NCT00436891|"     Group A streptococcus (GAS) is a bacteria that causes many different sicknesses in children     and adults. This study will look at the number of cases of pyoderma (bacterial skin     infection) and scabies (skin mites that cause itching) in 550 infants 12 months or younger in     Fiji. (GAS can cause pyoderma, and sometimes skin sites infested with scabies can become     infected with GAS bacteria.) The study will also look at the makeup of GAS and how certain     medications affect GAS. The infants will be involved in the study for approximately 1 week.     Their skin will be examined for pyoderma and scabies. A swab sample will be taken from the     pyoderma area to test for GAS. The researchers hope to see how often these skin infections     occur and how they affect the Fijian population. The information will help the researchers to     develop better treatment and possibly a vaccine to prevent infection. Infants with pyoderma     that is defined as greater than mild will be referred for treatment.   "
197827|NCT00436904|"     RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or carry cancer-killing substances to them. Giving     alemtuzumab together with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects and how well giving alemtuzumab     together with rituximab works in treating patients with high-risk, early-stage chronic     lymphocytic leukemia.   "
197828|NCT00436917|"     RATIONALE: Zoledronate may reduce bone loss in patients receiving letrozole for breast     cancer.      PURPOSE: This clinical trial is studying how well zoledronate works in treating osteopenia or     osteoporosis in postmenopausal women receiving letrozole for stage I, stage II, or stage IIIA     primary breast cancer.   "
197829|NCT00436930|"     RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body     build an effective immune response to kill tumor cells. Colony-stimulating factors, such as     GM-CSF, increase the number of white blood cells and platelets found in bone marrow or     peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment     for melanoma.      PURPOSE: This randomized phase II trial is studying two different vaccine therapy regimens to     compare how well they work when given together with GM-CSF in treating patients with     recurrent or metastatic melanoma.   "
197830|NCT00436943|"     The researchers hypothesize that smoking cessation counseling improves with the     implementation of a smoking status assessment data sheet in routine consults. This is a     quality improvement study design to evaluate the impact of the implementation of a more     formal smoking status evaluation in a resident/faculty driven outpatient clinic.   "
197831|NCT00436956|"     Background:        -  AZD2171 (Cediranib) is an experimental drug that inhibits formation of new blood          vessels.        -  Tumors need new blood vessels to grow. Preventing the growth of new blood vessels with          AZD2171 may inhibit tumor growth.      Objectives:      -To determine the effectiveness and side effects of AZD2171 in patients with prostate cancer     that has metastasized (spread beyond the primary site).      Eligibility:        -  Males 18 years of age and older with androgen-independent prostate cancer that has          metastasized.        -  Patients must have received prior treatment with docetaxel.      Design:      Patients take one AZD2171 by mouth every day in 28-day treatment cycles and undergo the     following procedures:        -  1- to 2-day hospitalization at the start of the study for biopsies and blood          measurements to determine the level of AZD2171 in the bloodstream. Blood is drawn          immediately before the first dose, and 0.25 hr, 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12          hr, 24 hr, and 48 hours after the dose is taken.        -  Blood tests before starting treatment and then monthly to determine the level of          vascular endothelial growth factor receptor ( VEGFR), a protein involved in blood vessel          formation.        -  Magnetic resonance imaging (MRI) scans once a month to evaluate blood flow.        -  Tumor biopsies (optional) both before and after the second and sixth treatment cycles.        -  Clinic visits every 4 weeks, including various routine and research blood tests, urine          test and electrocardiogram.        -  Computed tomography (CT) scan of the chest, abdomen, and pelvis every 8 weeks        -  Bone scan every 8 weeks      Patients record all doses of AZD2171 taken or missed in a pill diary. They record their blood     pressure at least once daily in a blood pressure diary.      Treatment may continue as long as the patient tolerates the AZD2171 and the cancer does not     worsen.   "
197832|NCT00436969|"     A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to     osteoarthritis.   "
197833|NCT00436982|"     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric     behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective     randomized clinical trial.   "
197834|NCT00436995|"     The purpose of this study is to assess the proportion of subjects sucessfully achieving a     mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following     extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.   "
197835|NCT00437008|"     The purpose of the study is to determine whether there are differences in postprandial     endothelial function following a high-AGE(Advanced Glycation End-products) meal vs. a low-AGE     meal. We also intend to investigate if the therapy with 1050mg Benfotiamine for 3 days     protects against the postulated deterioration of endothelial function after a high-AGE meal     in people with type 2 diabetes mellitus.   "
197836|NCT00437021|"     The purpose of this study is to evaluate an investigational smallpox vaccine, called     IMVAMUNE®, with respect to safety and immune (body's defense system) response. Participants     will include healthy adults, age 18 or older born after 1971, who have not had smallpox     vaccine before. Volunteers were originally assigned to 1 of 5 groups. In July 2007, a hold     was placed on the Dryvax® groups and the study was modified. Volunteers, numbering 197, will     be assigned by chance to one of 3 groups to be vaccinated twice with IMVAMUNE® vaccine or     placebo (inactive substance) in Groups A and B, or to receive a single vaccination with     IMVAMUNE® or placebo in Group F. Volunteers will complete a memory aid (diary) for 15 days     following vaccination. Blood samples will be collected. Volunteers may participate for up to     425 days.   "
197839|NCT00437073|"     This study is for patients with ErbB2 overexpressing breast cancer that has spread to the     brain and is still progressing there even after radiation treatment using WBRT (whole brain     radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how     safe and effective lapatinib is when given in combination with capecitabine to treat patients     with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral     drug that will be taken every day. Tests for safety and efficacy will be performed regularly     during the course of the study.   "
197840|NCT00437086|"     RATIONALE: Bortezomib may stop the growth of abnormal cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the abnormal cells.      PURPOSE: This clinical trial is studying the side effects and how well bortezomib works in     treating patients with advanced myeloproliferative disorders.   "
197841|NCT00437099|"     Borderline Personality Disorder (BDP) is a serious mental disorder that affects about 1-2% of     the general population, and it is characterized by severe psychosocial impairment and a high     mortality rate due to suicide. Currently, the most effective treatments for BPD are     psychotherapy (cognitive behavior therapy - CBT -) and pharmacotherapy (often as an important     adjunctive role, especially for diminution of symptoms such as affective instability,     impulsivity, psychotic-like symptoms and self-destructive behavior). Nevertheless, although     several drugs are used in these patients, these drugs induce an improvement of some symptoms     but do not cause the remission of BPD. Thus, identification of novel treatments is needed.      The objective of this study is to examine the efficacy of Omacor® ( a mixture of omega-3-acid     ethyl esters: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ) for BDP patients     receiving CBT. Patients with BDP will be randomly allocated to the three arms of the study:     1- CBT+placebo, 2- CBT+Omacor 1680 mg/d, 3- CBT+Omacor 3360 mg/d. Follow up will last for 12     weeks. Assessment of affective symptoms, impulsivity and aggressivity will be carried out at     baseline and at 2, 4, 6, 8, 10 and 12 weeks.   "
197842|NCT00437112|"     A study to compare Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a     registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type     2 diabetes who are currently taking oral medications and have not previously taken insulin.     Change in HbA1c levels will be reviewed to determine superiority or inferiority of the AIR     Inhaled Insulin regimen.   "
197843|NCT00437125|"     This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label     fashion, in depressed patients with Parkinson's disease during 12 weeks treatment.   "
197844|NCT00437138|"     Air pollution is a major cause of cardiovascular morbidity and mortality. The components of     air pollution responsible and the mechanisms through which they might mediate these harmful     effects remain only partially understood. We hypothesise that these adverse effects are     mediated by combustion derived air pollutants and that even a brief exposure will effect     heart and blood vessel function. We assess the effect of dilute diesel exhaust inhalation at     levels encountered in urban road traffic on heart and blood vessel function in patients with     stable coronary heart disease.   "
197845|NCT00437151|"     The primary objective of this study is to investigate potential differences in treatment     adherence by teenagers among four interventions during treatment for acne.   "
197846|NCT00437164|"     Many drugs used for the treatment of Type 2 Diabetes Mellitus cause the body to retain water.     This study will assess whether or not GW677954 causes the body to retain fluid.   "
197847|NCT00437177|"     OH dependence is associated with DA receptor changes. Both, the apomorphine test and the     D2Rec SPECt are usefull for monitoring DA receptor status. We aimed at studying whether DA     receptor hypofunction, assessed by means of the apomorphine test and the D2Rec SPECT, is a     marker of relapse in detoxified OH dependents patients.   "
197848|NCT00437190|"     The purpose of this study is to establish the safety and effectiveness of the BRYAN(R)     Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical     spine.   "
197849|NCT00437203|"     To determine the overall safety of PF-00477736 when given in combination with gemcitabine, a     chemotherapy agent, in patients with advanced solid tumors and determine the maximum dose of     PF-00477736 that can be safely given in combination with gemcitabine. This is the first study     of PF-00477736 in humans.   "
197850|NCT00437216|"     Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on     therapy to existing systemic or topical anti-psoriatic agents.   "
197851|NCT00437229|"     GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study     is designed to test the safety and the extent of the GW679769 affect on dexamethasone and     ondansetron levels in humans.   "
197852|NCT00437242|"     This study is being completed to demonstrate the lack of effect of repeat dosing with     Odiparcil on the QTc interval.   "
197853|NCT00437255|"     Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall     Disease Severity and Investigator Global Assessment.   "
197854|NCT00437268|"     To see how well enzastaurin in combination with irinotecan and cetuximab works versus     irinotecan and cetuximab in patients who have progressed within 3 months.   "
197856|NCT00437294|"     The purpose of this study is to determine whether the combination of enzastaurin and     capecitabine is more effective than the combination of placebo and capecitabine in treating     patients with breast cancer who were previously treated with an anthracycline and a taxane.   "
197857|NCT00437307|"     Determination of progression free survival after 12 months of FU      Determination of total survival, response and quality of life   "
197897|NCT00430547|"     The purpose of this study is to determine whether radioactive iodine, as compared to     anti-thyroid medications, is a risk factor for the development or progression of     thyroid-associated ophthalmopathy in patients with hyperthyroidism due to Graves' disease.     The other aim of this study is to determine the incidence of the various ophthalmopathy     subtypes and the utility of orbital antibodies in the diagnosis, classification and     monitoring of patients with thyroid-associated ophthalmopathy.   "
197858|NCT00437320|"     Skin photoaging or skin photodamage are terms used to describe the change in the structure,     function and appearance of skin caused by prolonged and repeated exposure to sunlight or     other ultraviolet light sources.      The visible effects of skin photodamage are fine lines, skin sagging, skin roughness, liver     spots and also the appearance of red patches made up of thin red vessels (called     telangiectasia).      More and more people are presenting to doctors with concerns about skin photodamage and the     demand for corrective procedures is increasing.      Metvix® photodynamic therapy (Metvix® PDT) is a procedure currently marketed in several     countries in Europe (including the United Kingdom [UK] and Spain) and in Australia, for the     treatment of benign forms of skin cancer (e.g. actinic keratosis).      The aim of the study is to assess whether Metvix® PDT will be effective in correcting the     effects related to photodamage and whether it will be well tolerated.   "
197859|NCT00437333|"     Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory     patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the     long-term metformin administration are know but no data are available on the effects after     its suspension.      The purpose of this study is to evaluate the effects of metformin suspension on insulin     sensitivity in PCOS patients.   "
197860|NCT00437346|"     Study title: Functional dyspepsia -- effect of acid reducing treatment and individualized     information.      Summary: 15-20% of all people experience dyspepsia each year. Dyspepsia means pain or     discomfort in the upper part of the abdomen. Accompanying symptoms from the esophagus may be     present. The most important relevant medical examination is gastroscopy, and if the findings     are normal the condition is usually classified as functional dyspepsia.      Several disturbances of function are now known as potential causes of such symptoms, and the     optimal choice of treatment may vary.      In the study the investigators plan to examine whether different types of functional     disturbances respond differently to medical therapy. In particular, the investigators want to     assess whether comprehensive and individualized information will influence the results of     therapy. This has not been previously studied systematically.      The investigators also postulate that disturbances of function of the esophagus may cause     complaints that should be classified as functional dyspepsia even if the symptoms are     atypical. Few studies have been done to evaluate this hypothesis, and there may be potential     consequences for choice of appropriate treatment.      In animal models and in humans is recently demonstrated that elevated gastric pH because of     anti-ulcer treatment can trigger food allergy. We use a proton pump inhibitor in our study     and eventually development of food allergy will influence patient's condition in an     observations period. That why we're observing IgE dynamics in our study.   "
197861|NCT00437359|"     To investigate the benefit of postoperative adjuvant therapy using sequential administration     of the hormone, toremifene citrate (TOR) or anastrozole (ANA), after chemotherapy in breast     cancer.   "
197862|NCT00437372|"     This study is using the combination of radiation and antiangiogenic agents (agents that     destroy existing blood vessels) seems to be an approach to tumor cure.   "
197863|NCT00437385|"     The purpose of this study is to evaluate three different continuation treatments after acute     ECT concerning efficacy and impact on cognition in severly depressed patients.   "
197864|NCT00437398|"     The complex program of insulin replacement for type 1 diabetes that is current clinical     standard of care is difficult to implement for long periods of time, associated with an     increased risk of severe hypoglycemia and implemented by less than 50 % of the population of     such patients. Outcomes of transplantation of isolated human islets have substantially     improved and been performed at about 40 institutions around the world. We are proposing a     clinical phase 1/phase 2 study of islet transplantation alone evaluating safety and efficacy     in five patients with type 1 diabetes. Islet isolation from deceased donor pancreases will be     performed at the Mayo Rochester Islet Isolation facility and islets infused by Interventional     Radiology into the portal venous system. Following islet infusion, patients will be     hospitalized for 48 hours in the General Clinical Research Center (GCRC) or at the Rochester     Methodist Hospital. Multiple safety and efficacy outcomes will be followed on multiple     occasions during the first year and periodically thereafter.   "
197865|NCT00437411|"     The investigators are studying whether a brief three-session mind-body workshop helps people     with fibromyalgia. The investigators hypothesize that this workshop will significantly     improve pain and other symptoms, compared to usual care.   "
197866|NCT00437424|"     The primary purpose of this protocol is to determine the effect of BMS-582664 on patients     with hepatocellular carcinoma with varying levels of hepatic impairment   "
197867|NCT00437437|"     The purpose of this trial is to determine the effect of food versus a fasted state on     single-dose pharmacokinetics of BMS-540215, the active metabolite of Brivanib alaninate   "
197868|NCT00437450|"     The purpose of this study is        -  To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in          patients with low risk myelodysplastic syndromes        -  To evaluate the tolerance of this treatment   "
197869|NCT00437463|"     To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA     nephropathy.   "
197870|NCT00437476|"     The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV     drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN     + ritonavir in patients naive for HIV and HCV.      Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with     HIV efficacy vs optimized HAART.   "
197871|NCT00437489|"     The primary objective of this study is to assess whether a simple initial dose prescription     of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is     non-inferior compared to the standard weight-based formula.   "
197898|NCT00430560|"     This research investigates the benefits of productive activity and cognitive rehabilitation     for patients with schizophrenia. Key questions are:        1. does cognitive rehabilitation plus work activity produce better outcomes than work          activity alone?        2. Is cognitive rehabilitation more helpful for individuals with moderate or greater          cognitive impairment than for individuals without such impairment?        3. Does cognitive rehabilitation reduce the dropout rate and increase participation in work          activity for cognitively impaired subjects?        4. What features of cognitive rehabilitation are most important for clinical and          rehabilitation outcomes?   "
197872|NCT00430196|"     In this study, we will compare BOTOX® versus Zanaflex ® for the treatment of muscle     overactivity in the upper limb following stroke or brain traums. This is a critical step in     the development of local intramuscular treatment for patients with muscle overactivity     following an acute brain lesions, as opposed to the more classic oral treatments.      This study will be a multicenter, randomized, prospective, parallel, double blind study that     enrolls subjects at twelve sites (including Mt. Sinai) throughout the United States and     Europe. The purpose of this study is to evaluate the safety and efficacy of BOTOX® compared     to Zanaflex® in reducing upper limb muscle tone in post-stroke subjects, as well as     evaluating changes in muscle tone-related disability and drug-therapy tolerance. This will be     an 18 week study. Subjects are eligible if they have been medically stable with upper limb     spasticity 6 months after their first stroke. Subjects will be randomized to one of three     treatment groups: Treatment Group I - intramuscular BOTOX® plus oral placebo, Treatment Group     II - intramuscular placebo plus oral Zanaflex®, Treatment Group III - intramuscular placebo     plus oral placebo. The dose of BOTOX® will be at the discretion of the investigator with a     maximum of 500 U per subject. The dose of the Zanaflex® will be 4mg/day to a maximum of     36mg/day. The study anticipates that 150 subjects will be enrolled to provide sufficient     information to answer the primary objective of safety and efficacy of the study.   "
197873|NCT00430209|"     We hypothesize that glaucoma patients demonstrate an impaired retinal vascular response to     the flicker stimulus, and that this disturbance is predictive of the progression of     glaucomatous damage.      The response of a major temporal superior and inferior retinal artery and vein to a 60     seconds 12.5 Hz flicker light stimulation in 50 glaucoma patients, 50 ocular hypertensives     and 50 controls (using the Retinal Vessel Analyzer) and to investigate how intraocular     pressure relates to neurovascular coupling. In addition, 50 glaucoma patients and 50 ocular     hypertension patients will be followed for 3 years for functional (visual field, automated     perimetry with Octopus device) and morphological (retinal nerve fiber layer thickness,     Optical Coherence Tomography Stratus ocular coherence tomography (OCT) device) glaucomatous     damage progression, in order to test the predictive power of the retinal vascular flicker     response for glaucoma progression.   "
197874|NCT00430235|"     Purpose:      To determine the efficacy of BAY 43-9006 in combination with bicalutamide in patients with     chemo-naïve hormone-refractory prostate cancer.      Hypothesis:      That there will be PSA response when BAY 43-9006 in combination with bicalutamide is given to     patients with chemo-naïve hormone-refractory prostate cancer.   "
197875|NCT00430248|"     The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily     (QD), to allopurinol in subjects with hyperuricemia and gout.   "
197876|NCT00430261|"     This is an open-label study of a new oral drug for advanced stage (IIIB or IV) lung cancer.     The cancer must be EITHER bronchoalveolar carcinoma (BAC) type, or if the patient is a     never-smoker (less than 100 cigarettes lifetime) the cancer can be any type of     adenocarcinoma.   "
197877|NCT00430274|"     Retinal structures are difficult to visualize because the retina is optically transparent. In     glaucoma, the microglia in the retina becomes activated in eyes with glaucomatous damage. The     microglia forms a dense meshwork which resembles gliosis-like alterations, which may increase     light scattering. With appropriate technology, increased reflection and light scattering from     the retina may be detected in eyes of glaucoma patients.      In this study, we investigate whether clinically observable retinal gliosis-like alterations     occur more often in patients with glaucoma than in non-glaucomatous controls, and whether     gliosis-like alterations are associated with a vasospastic propensity.   "
197878|NCT00430287|"     The purpose of this study is to determine how well the DDLS (Disc Damage Likelihood Scale)     (which is a method used by the eye doctor to evaluate how healthy the optic nerve is)     measures up to the standard glaucoma tests: OCT (Optical Coherence Tomography), the HRT     (Heidelberg Retinal Tomography) and the HVF (Humphrey Visual Field).   "
197879|NCT00430300|"     Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in     patients with chronic obstructive pulmonary disease.   "
197880|NCT00430313|"     Objectives:      This protocol is part of a larger grant funded by the NCI to create an international research     center to study Traditional Chinese Medicine (TCM). All of the patients enrolled in this     study will be treated at the Cancer Hospital, Fudan University, investigator's sister     institution in Shanghai, China. No patients will be seen at MDACC. This protocol will be     overseen by the Fudan University Institutional Review Board (IRB00002408) which has Federal     Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25,     2002). The research nurses have received training at MDACC and will receive regular oversight     by MDACC personnel.      The purpose of this randomized, placebo controlled study is to determine the effects of K1     acustimulation at controlling chemotherapy induced nausea and vomiting (CINV).        1. The primary aim of this study is to determine the effects of electro-stimulation of          Yongquan (K1) acupoint on preventing nausea and vomiting induced by cisplatin or          oxaliplatin.        2. The secondary aim is to observe the effects of electro-stimulation (ES) of Yongquan (K1)          acupoint on pain, insomnia, abdominal distention, dizziness, and general sense of          well-being.   "
197881|NCT00430326|"     This trial is being undertaken to investigate the efficacy and safety of Juvista in the     improvement of scar appearance when administered to approximated wound margins following     varicose vein surgery. The results from this trial will be used to select doses for     investigation in future clinical trials with the compound.   "
197882|NCT00430352|"     This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy     following a MabThera-containing induction regimen in first line or relapsed patients with     follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface     area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is     1-2 years, and the target sample size is 500+ individuals.   "
197883|NCT00430365|"     Maintenance treatment of myeloma.   "
197899|NCT00430573|"     This study examines whether isolated doses of d-cycloserine enhance the efficacy of an     exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance     dependence.   "
198323|NCT00445146|"     The main objective of this study is to observe the long-term safety of elvitegravir (EVG)     boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in     participants who have completed a prior EVG+RTV treatment study.   "
197884|NCT00430378|"     The goal of this clinical research study is to learn if acupuncture is effective in     preventing xerostomia (dry mouth) in cancer patients who receive radiation treatment to the     head and neck area. Researchers also want to learn whether acupuncture lowers the severity of     dry mouth that is experienced by these patients.      Primary Objective:      -Investigate if acupuncture is effective in preventing xerostomia among cancer patients at     Fudan University Cancer Hospital (Cancer Hospital) who receive radiation treatment to the     head and neck area.      Secondary Objectives:        -  Determine whether acupuncture reduces the severity of xerostomia.        -  Determine the feasibility of providing acupuncture treatment to patients at Cancer          Hospital who are receiving radiation treatment for cancer of the head and/or neck area.   "
197885|NCT00430391|"     The purpose of this study is to examine a novel technique for improving the informed consent     process for participation in research by the older psychiatric population.   "
197886|NCT00430404|"     To evaluate the effectiveness of a community-based strategy of routine population mass     screening for depression with follow-up feedback and management in a primary care     non-psychiatric setting involving a structured, multifaceted, collaborative (primary care and     hospital-based)shared care programme.      Hypotheses:      We hypothesize that a community-based early psychiatric interventional strategy (CEPIS) for     depression in the elderly leads to increased recognition of depression by primary care     physicians, more initiation of treatment for emotional problems, and improved outcomes for     patients with depression, as measured by:        1. increased rates of detection or recognition by a primary care physician of minor or          major (clinical) depression.        2. higher rates of management activities: counselling for psychological, family social          problems, contact with community family services (human service agency), consultation          and/or referral to a mental health specialist        3. Reduced depressive symptom severity, improved level of daily functioning and quality of          life among those with major clinical depression        4. Better patient satisfaction with care        5. Favourable clinician's and patients perception of their usefulness or acceptability   "
197887|NCT00430417|"     The primary aim of the study is to measure bone formation in both lactating and non-lactating     post-partum women and compare these to those in healthy non-pregnant controls. The secondary     aim is to obtain measurements of Parathyroid Hormone-related Protein (PTHrP), markers of bone     resorption, and calcium and vitamin D metabolism in these subjects. The investigators believe     that lactating women will have an increase in bone resorption but no increase in bone     formation when compared to non-lactating post-partum women and normal controls.   "
197888|NCT00430430|"     Low and very low carbohydrate diets, such as the Atkins' Diet, have recently gained attention     for their potential health benefits from weight loss and have gained some scientific support     from a growing number of studies. Benefits have been noted in relation to raised good     cholesterol, lower bad cholesterol and triglycerides. Other studies have shown an advantage     in substituting vegetable fat for carbohydrate in insulin resistant individuals and in some     instances in type 2 diabetes where improvements were seen in good cholesterol and blood     sugars. At the same time, our research have been exploring diets containing less processed     carbohydrates and other components which in combination (portfolio diet) have a similar     cholesterol lowering effect to drug therapy.      Therefore we wish to determine whether our cholesterol-lowering components (portfolio diet)     should be incorporated into lower carbohydrate diets especially to preserve good     cholesterol and lower bad cholesterol for decreasing the risk of heart disease.   "
197889|NCT00430443|"     This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal     annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment     will occur in cohorts of approximately 3 subjects with 10 additional subjects enrolled at the     MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Six dose levels     of liposomal annamycin are planned: 130, 160, 190, 230, 280, and 310 mg/m2/day.The primary     objectives of this study are 1) to evaluate the safety and identify the maximum tolerated     dose (MTD) of liposomal annamycin when given in 3 consecutive daily doses, starting at 130     mg/m2/day and ranging to as high as 310 mg/m2/day, or the MTD, whichever is lower, in     children and young adults with refractory or relapsed acute lymphocytic leukemia (ALL) or     acute myelogenous leukemia (AML), and 2) to evaluate the antileukemic activity of liposomal     annamycin in children and young adults with refractory or relapsed ALL or AML. The secondary     objective is to measure the pharmacokinetics of annamycin and its metabolite, annamycinol.   "
197890|NCT00430456|"     Individuals disabled by stroke are at risk of losing cardiovascular fitness and muscle due to     disease. This worsens disability and can increase the risk of having another stroke or a     heart attack. We would like to find out if and how different types of regular exercise     (intense walking, long walking) can increase fitness, balance and improve walking function     and activities of daily living in individuals who have suffered a stroke.   "
197891|NCT00430469|"     The safety and tolerability of hLF 1-11 given in multiple doses has to be established first     in HSCT recipients who are at risk of developing, but have not yet developed, infectious     complications due to invasive fungal or bacterial disease. These patients are different from     healthy volunteers because they have received myeloablative treatment, which not only arrests     haematopoiesis resulting in neutropenia but also induces mucosal barrier injury both of which     predispose to infections, which typically occur during the week after transplant. It is     therefore essential to know that hLF 1-11 is safe and well tolerated when given during     neutropenia and mucosal barrier injury before infections ensue.   "
197892|NCT00430482|"     This study is designed to evaluate the relative efficacy of a novel treatment (CBT-IC) versus     a standard individual drug-counseling treatment. The novel treatment emphasizes exposure to     emotional cues for drug use as part of a comprehensive, yet brief, treatment strategy. These     treatments are delivered to opiate-dependent, often poly-substance dependent, individuals in     a comprehensive methadone maintenance program who have failed to respond adequately to     current treatments.   "
197893|NCT00430495|"     This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective     dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid     arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha     (TNFa) antagonist due to lack of efficacy.   "
198372|NCT00445835|"     Coronary artery disease is the first cause of death related to atherothrombosis.   "
197900|NCT00430586|"     NT 201 is a botulinum toxin type A preparation free of complexing proteins, i.e. free of     proteins other than the active toxin. Injected into the muscle, NT 201 causes local weakening     to full paralysis depending on the administered dose. Botulinum toxin type A is widely used     for aesthetic treatment of facial lines. This study will determine the optimal dose of NT 201     in the treatment of glabellar frown lines.   "
197901|NCT00430599|"     We are carrying out this study to determine whether Keppra (a drug usually used to treat     epilepsy) is an effective treatment for tremor in patients with Multiple Sclerosis. Tremor is     one of the most common symptoms in MS, but also one of the most difficult to treat. A very     small previous study has indicated that Keppra may be effective in this role, but we need to     reproduce these results in many more patients before we can reliably confirm this.   "
197902|NCT00430612|"     The purpose of the PACE-MI (OBTAIN) registry is:        -  Analyze beta-blocker dose response effect on outcome over two years        -  Explore gender and minority differences in beta-blocker utilization and outcomes.      In patients with Myocardial Infarction (MI) discharged from the hospital, beta-blocker dose     will be predictive of survival.      Exploratory analyses: Gender and racial effects—gender and race are, similarly, hypothesized     to be predictive of post-MI survival.      The existence of interactions between gender and beta-blocker effect as well as race and     beta-blocker effect will also be evaluated.   "
197903|NCT00430625|"     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme     glucocerebrosidase (GCB). Due to this deficiency of functional GCB, glucocerebroside     accumulates within macrophages leading to cellular engorgement, organomegaly, and organ     system dysfunction. The purpose of this study is to evaluate the efficacy of every other week     dosing of Gene-Activated® Human Glucocerebrosidase (GA-GCB, velaglucerase alfa) at doses of     45 and 60 U/kg in treatment-naïve patients with type 1 Gaucher disease.   "
197904|NCT00430638|"     This 16 week study will examine the ability of olmesartan medoxomil to lower the blood     pressure of patients with moderate to severe high blood pressure in comparison to placebo.     The medication being tested has been approved by the FDA for the treatment of high blood     pressure.   "
197905|NCT00430651|"     This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second     line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated     previously with Docetaxel.   "
197906|NCT00430664|"     Pleurodesis is a technique used to fuse the two layers of the lining over the lung. This is     done to get rid of collections of fluid or air in this space. A common reason would be cancer     of the underlying lung or elsewhere causing fluid to collect in the pleural space. In this     situation it is a palliative procedure to free the patient from symptoms like breathlessness.   "
197907|NCT00430677|"     The purpose of this clinical research study is to learn if addition of abatacept is safe and     improves the effectiveness of treatment of patients with active lupus nephritis who are also     taking mycophenolate mofetil (MMF) and corticosteroids.   "
197908|NCT00430690|"     Chronic cocaine administration leads to changes in brain function that persist long after the     acute withdrawal phase. The acoustic startle response (ASR) is a well characterized reflexive     response to a sudden acoustic stimulus. The ASR is mediated by a simple 3-synapse subcortical     circuit; it is modulated in part by brain areas and neurotransmitters associated with cocaine     administration. Our initial study and subsequent replication reveals a profound diminution of     the ASR in cocaine-dependent subjects after a brief period of abstinence. Our preliminary     findings indicate that first degree relatives of cocaine-dependent subjects also have reduced     startle compared to healthy controls. The findings of low ASR in rats and humans during     cocaine washout and low ASR in family members suggests there may be both a trait and state     component of the startle reductions we have reported.      The central objectives of this proposal are to dissect this finding with regard to its     development and persistence in early and later phases of cocaine abstinence in humans; to     ascertain whether startle reduction and its potential normalization during later abstinence     is a predictor of clinical course in human subjects with cocaine dependence; and to examine     whether startle reduction is, at least in part, a vulnerability trait for the development of     cocaine dependence. This latter Aim will be carried out in humans by testing siblings of     cocaine-dependent subjects.      Cocaine dependence is an enormous public health problem. The significance of this work lies     in the potential for the ASR reduction to serve as a reliable, easily repeatable biological     measure of cocaine-induced brain changes that may enhance outcome prediction so that tailored     treatments may be directed at those patients most vulnerable to relapse, given the     restriction of resources for available for substance abuse treatment.   "
197909|NCT00430703|"     The aim of this study is to determine whether passive gait training increases arousal,     demonstrated as changes in EEG (electroencephalogram) activity.      Hypotheses: 1) Passive gait training increases EEG-frequency in patients with impaired     consciousness due to severe traumatic brain injury.      2) Passive gait training increases conductivity speed of the cognitive P300-component of ERP     in patients with impaired consciousness due to severe traumatic brain injury.   "
197910|NCT00430716|"     To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment     of subjects with PAH.   "
197911|NCT00430729|"     The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on     exacerbation rate and pulmonary function as well as quality of life in patients with chronic     obstructive pulmonary disease (COPD).   "
197912|NCT00430742|"     A worldwide study with extension in patients with type 2 diabetes mellitus to assess the     safety and tolerability as well as the effects of treatment with an investigational drug for     weight loss on body weight.   "
197934|NCT00431028|"     The purpose of this study is to compare one intraoperative sub-Tenon's capsule injection of     triamcinolone and ciprofloxacin in a biodegradable controlled-release system with     conventional prednisolone and ciprofloxacin eye drops to treat ocular inflammation and for     infection prophylaxis after cataract surgery.   "
197913|NCT00430755|"     Aim:      To investigate the quality of history taking by physician and computer-based system.      Patients:      100 inpatients presenting at the RBK for the first time and treated in the departments of     nephrology and cardiology.      Methods:      The information obtained by the computer based system is compared with the information     acquired by conventional history taking. Study endpoint is the comparison of historical data     organized according to the elements in a standard medical history on a patient-by-patient     basis.      Study procedure History taking is performed by physicians according to the guidelines of the     RBK. Within 2 days thereafter the patient is interviewed with help of the CLEOS system with     the support of a study nurse.   "
197914|NCT00430768|"     Individuals with a deficiency of the alpha 1-antitrypsin (AAT) protein are at risk for     developing emphysema and liver damage. Researchers have developed a way to introduce normal     AAT genes into muscle cells with the expectation that the AAT protein may be produced at     normal levels. This study will evaluate the safety of the experimental gene transfer     procedure in individuals with AAT deficiency. The study will also determine what dose may be     required to achieve normal levels of AAT.   "
197917|NCT00430807|"     Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its     ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory     drug that may have a corticosteroid sparing potential according to immuno-pharmacological and     clinical data. We have designed a multcentric double blind versus placebo randomized     controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non     complicated giant cell arteritis.   "
197918|NCT00430820|"     The study hypothesis is that differential proteomic techniques can be used to discover new     circulating biomarkers of coronary atherosclerosis in the blood of patients suffering from     coronary artery disease (either stable or unstable) who will be compared to a group of     patients without coronary artery disease   "
197919|NCT00430833|"     The primary hypothesis of the study is that treatment with AT1-R antagonist in patients with     nonobstructive form of HCM will be first save, second will cause regression of myocardial     hypertrophy.   "
197920|NCT00430846|"     Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in     patients with relapsed/refractory CD30-positive hematologic malignancies. This is a     single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK,     immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory     CD30-positive hematologic malignancies.   "
197921|NCT00430859|"     Eligible patients will receive either AP or matching placebo in a double blind, randomized     design and following a 2:1 ratio. All medication will be given in addition to standard care     for sepsis patients. Patients will be followed for 28 days after the start of study     medication administration. A blinded safety review of the study results will take place after     the inclusion of 12 patients in the study.   "
197922|NCT00430872|"     The goal of this research study is to learn the severity of certain symptoms in patients with     tumors of the spine or spinal cord. Researchers also want to learn if the M. D. Anderson     Symptom Inventory-Spine is a good way to rate these symptoms.      Primary Objective:      1. To evaluate the psychometric properties of the MDASI-Spine in patients with tumors     involving the spine or spinal cord.      Secondary Objective:      1. To describe the severity of commonly occurring symptoms experienced by persons with spine     tumors.   "
197923|NCT00430885|"     The instigators hypothesize that IVIG, given in the acute phase following MI in patients at     risk for developing HF, will improve cardiac performance, and by attenuating cardiac     remodeling in this phase, such therapy will prevent the development of chronic HF resulting     in long term beneficial effect also after the therapy has been stopped.   "
197924|NCT00430898|"     The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two     levels of intravenous basiliximab in ulcerative colitis, compared to placebo.   "
197925|NCT00430911|"     A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or     older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma,     and a Karnofsky performance status > 70.   "
197926|NCT00430924|"     The purpose of this study is to examine whether the inhibition of aldosterone will result in     lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered,     progression of renal disease with be slower than otherwise expected.   "
197927|NCT00430937|"     This study evaluated the efficacy and safety of daptomycin compared to vancomycin or     teicoplanin for the treatment of complicated skin and soft tissue infections   "
197928|NCT00430950|"     The study will evaluate the blood pressure lowering effects of two different dosages of the     combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high     blood pressure.   "
197929|NCT00430963|"     IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing     proteins, i.e. free of proteins other than the active toxin. Injected into the muscle,     IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used     for aesthetic treatment of facial lines. This study investigated the efficacy and safety of     IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo.     The study consisted of a Main Period and an Open-Label Extension [OLEX] Period of 120 days     each.   "
197930|NCT00430976|"     The purpose of this study is to assess the effect of aerobic exercise on the brain and     cognition through the measurement of neuroelectric and behavioral indices of executive     control cognitive function in older adults.   "
197931|NCT00430989|"     To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors     for coronary artery disease undergoing major surgery.   "
197932|NCT00431002|"     The main purpose of this study is to investigate the effect of two different group-based     exercise programs on fall risk (muscular strength and balance) and bone strength in older     women aged over 65-75 years who have low bone mass. We are also trying to determine if once a     week exercise is as effective on health outcomes as twice a week. We hypothesize that twice a     week exercise will be more effective than once a week or sham exercise.   "
197933|NCT00431015|"     The purpose of this study is to determine the safety, tolerability and maximum tolerated dose     of IPI-504 in patients with non-small cell lung cancer (NSCLC). The study will examine how     IPI-504 is absorbed, distributed, metabolized and eliminated by the body. The study will also     evaluate the anti-tumor activity of IPI-504.   "
197936|NCT00431054|"     The goal of this clinical research study is to find out if a combination treatment of     perifosine and docetaxel will help shrink or slow the growth of cancer cells in recurrent     ovarian cancer. The safety of this combination treatment will also be studied.   "
197937|NCT00431067|"     The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive     metastatic breast cancer patients after failure of trastuzumab containing regimens.   "
197938|NCT00431080|"     Anthracycline-containing regimens are recommended as adjuvant treatment for women with node     positive breast cancer. In at least three large randomized clinical trials the addition or     sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based     regimen resulted in superior clinical outcome for women with node positive early breast     cancer. In two large randomized studies the dose dense administration with G-CSF support of     anthracycline-based and paclitaxel combination was superior to the same regimen administered     every three weeks without growth factors as adjuvant therapy in women with axillary node     positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel     in women with metastatic breast cancer   "
197939|NCT00431093|"     The present trial is undertaken to compare the effects of Tibolone with a low-dose HRT     regimen.   "
197940|NCT00431106|"     The combination of vinorelbine and gemcitabine seems to be an important part of the     chemotherapy regimens used in metastatic breast cancer patients following treatment failure     with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in     metastatic breast cancer patients following treatment failure with the combination of a     taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens     used in metastatic breast cancer patients. Whether the combination of vinorelbine and     gemcitabine or capecitabine administration is preferable is not yet known, especially in     patients with metastatic disease.   "
197941|NCT00431119|"     To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine     or mycophenolate mofetil for the treatment of bullous pemphigoid.   "
197942|NCT00431132|"     This trial is conducted in Europe. The purpose of this study is to evaluate endometrial     safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic     vaginitis.   "
197943|NCT00431145|"     Aim of the study is to show additional effects of the combined therapy of niacin and statins     analyzing number and function of EPCs and other stem cell populations and adiponectin as well     as hsCRP levels in patients with CAD.   "
197944|NCT00431158|"     Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is     provided by a machine called a ventilator or respirator. The purpose of this study is to find     out if a new method of setting the ventilator for patients with severe ARDS is better than     the standard, commonly used way of setting the ventilator.   "
197945|NCT00431171|"     The current study is a phase I open-label clinical trial to examine plasma levels after oral     lithium treatments in 20 subjects with chronic spinal cord injury. The subjects will receive     standard doses of oral lithium used in treatment of manic depression. The goal of the trial     is to show feasibility and safety of maintaining plasma levels of 0.6 mmol/L to 1.2 mmol/L     for six weeks in subjects with chronic spinal cord injury.   "
197946|NCT00431184|"     Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals.     To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind     study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases     manic symptoms.   "
197947|NCT00431197|"     This study is being done to learn how the male hormone , testosterone, affects pituitary     hormones in younger and older men. The pituitary is a gland in the brain that secretes     hormones, some of which normally control growth and fertility.   "
197948|NCT00431210|"     The purpose of this study is to determine the safety of making and giving Epstein-Barr virus     (EBV) immunotherapy products to subjects with nasopharyngeal carcinoma (NPC) associated with     EBV that has come back or spread to other parts of the body. EBV immunotherapy product is     made with white blood cells from the participants body that are collected intravenously. This     EBV immunotherapy product may stop cancer cells from growing abnormally. EBV immunotherapy     products have been used in several research studies for NPC. Information from these studies     suggests the EBV immunotherapy products may stop the growth of NPC in some subjects.   "
197949|NCT00431223|"     This project is a novel exploratory research project to investigate changes in activation     patterns of the dorsolateral prefrontal cortex (DLPFC) in inpatients with schizophrenia who     received a 12-week computerized cognitive remediation (CRT) program. The hypothesis is that     patients receiving CRT will show greater increase in activation patterns in the brain as     compared to controls, and the degree of brain activation will correlate with improvements in     working memory.   "
197950|NCT00431236|"     This is a Phase III trial designed to demonstrate that casopitant when added to dexamethasone     and ondansetron is more effective in the prevention of vomiting then dexamethasone and     ondansetron alone, in patients who receive a cisplatin-based highly emetogenic chemotherapy.   "
197951|NCT00431249|"     Peripheral arterial disease (PAD) is the most common manifestation of systemic     atherosclerosis and accounts for significant morbidity and mortality among end-stage renal     disease (ESRD) patients. However, few studies have identified the prevalence and clinical     impact of PAD in this specific population.      Objectives: To perform a single-blinded parallel, controlled trial to examine the effect of     cilostazol treatment on plasma VEGF levels, tissue factors , inflammatory markers (such as     IL-6, hsCRP) levels, oxidative stress markers in ESRD patients with PAD Material and methods     Fourty HD patients on maintenance HD for > 3months were enrolled in this prospective,     single-blinded, randomized study. These patients were randomly allocated into 2 arms. After     baseline assessment, patients in the treatment arm received 12 weeks of added on therapy with     cilostazol 100mg/day. Blood pressure, heart rate, oxidative stress (malonyldialdehyde,     protein carbonyl and ADMA), inflammatory markers (hsCRP, IL-6) and plasma, VEGF and tissue     factors levels were measured before and after treatment.   "
197952|NCT00431262|"     Newly detoxified alcoholics (N=60) are randomised to either antabuse (disulfiram) treatment     or the control group for a total of 6 months.All patients will receive cognitive behavioural     treatment in groups. The hypothesis to be tested is that more of the patients who receive     antabuse (disulfiram) will be alcohol free during the 6 months treatment period compared to     the control group. The trial is open.   "
197953|NCT00431275|"     This is an open-label, 2-arm study in which patients are randomized to receive either the     formulation that is being used in clinical trials or the formulation that will be used when     if the drug becomes commercially available. The purpose of this study is to compare the     pharmacokinetics of the two formulations.   "
197956|NCT00431314|"     The aim of this study is to determine the vascular condition of hemodialysis patients with     toe pressure measurement, finger pressure measurement and measuring glycated and oxidated     proteins by skin autofluorescence.      Hypothesis: Lowering of finger pressure/toe pressure during hemodialysis, especially in whom     with a arteriovenous fistula, may contribute to critical limb ischemia in the extremities.   "
197957|NCT00431327|"     To identify patients at risk for nonattendance to their first scheduled colonoscopy and to     conduct a randomized trial of a theory-based, peer coach intervention on completing the     scheduled colonoscopy.   "
197958|NCT00431340|"     This open-label study will assess anti-tumor activity and safety of belinostat in combination     with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at     least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and     bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.   "
197959|NCT00431353|"     This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with     intravenous ganciclovir for the treatment of CMV disease in solid organ transplant     recipients. Eligible patients will be randomized to receive either 1)Valcyte 900mg po bid or     2)ganciclovir 5mg/kg iv bid. The anticipated time on study treatment is 1-2 years and the     target sample size is 100-500 individuals.   "
197960|NCT00431366|"     This study will explore sequence effect, a fatigue or tiredness commonly seen in patients     with Parkinson's disease after they have been doing the same thing for a while. The study     will use a new device called a modified peg board test (see description below) to measure     whether antiparkinsonian medications (levodopa/carbidopa or dopamine) and repetitive     transcranial magnetic stimulation (rTMS, see description below) of the brain can improve the     symptoms of sequence effect.      Patients with early-stage Parkinson's disease who have never taken antiparkinsonian     medications and patients with advanced disease may be eligible for this study. Candidates     must be 18 years of age or older and right-handed.      Participants have five visits to the NIH Clinical Center as follows:        -  Visit 1 (baseline): Patients have a neurological examination, including brief cognitive          function tests, a rating for depression, and two types of ratings for fatigue severity.        -  Visits 2 through 5 (experimental sessions): Patients who have been taking antiparkinson          medication for a long time are asked to not take their medication for about 12 hours          (overnight withdrawal) before visits 2 through 5. They are off medication for about 14          hours total (until after the experiments are done). Patients may be admitted to the NIH          Clinical Center for the overnight drug withdrawal if necessary. At the start of each          session, participants are given either levodopa/carbidopa tablets or placebo (tablets          identical in appearance but with no active medication). They perform the modified          pegboard test before medication, after medication, and after brain stimulation with          rTMS. During two of the sessions, they receive actual brain stimulation, and during the          other two sessions they receive sham stimulation, which does not actually stimulate the          brain.      The modified pegboard test is a computer-based machine with eight pegs. Subjects transfer     each peg from a line of holes on the right side to a line of holes on the left side using     their right hand and moving as quickly as possible. After they finish moving all pegs to the     left line of holes, they wait for a beep and then transfer the pegs from left line to right     line of holes. They do this six times, three times with their right hand and three times with     their left.      rTMS involves repeated magnetic pulses delivered in trains or short bursts of impulses. A     brief electrical current is passed through a wire coil held on the scalp. The current creates     a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling     sensation on the skin under the coil. There may be a twitch in muscles of the face, arm or     leg. During the stimulation, the subject may be asked to tense certain muscles slightly or     perform other simple actions. The effect of TMS on the muscles is detected with small metal     disk electrodes taped onto the skin of the right hand. Subjects receive four rTMS blocks per     10 minutes. Each block consists of a total of 375 pulses.   "
197961|NCT00431379|"     The pathogenesis of ARDS appears to be from damage to the alveolar-capillary barrier, which     is composed of the microvascular endothelium and the alveolar epithelium. This damage may     occur from direct or indirect lung injury. The mechanism of injury to the alveolar capillary     barrier appears to be through neutrophil-mediated injury, pro-inflammatory cytokines,     ventilator-induced lung injury with alveolar over distention and abnormalities of the     coagulation system. This results in blood clot formation in the microcirculation of the lung.     Thrombolytics can dissolve blood clots and result in increased blood flow to the organs. This     treatment may benefit ARDS patients, thus the purpose of this study.      Hardaway, et al.studied the effects of thrombolytics on ARDS in pigs. The experimental group     showed improved oxygenation and survival as compared to controls. There was no bleeding     complications noted with this therapy. Dr. Hardaway followed this animal study with a phase I     clinical trial involving 20 patients with ARDS. The patients were treated with IV     streptokinase or urokinase. Nineteen of the 20 patients showed an increase in PA02 after     thrombolytic therapy. There were no significant bleeding complications in patients that were     critically ill on ventilators.      We propose an additional phase I pilot study to evaluate the effectiveness and safety of     Tenecteplase for the treatment of ARDS. Unlike the other fibrinolytics studied in this     disease state, Tenecteplase, is more fibrin specific and has increased resistance to     plasminogen activator inhibitor (PAI-I) at greater levels than other available fibrinolytics.     We have chosen an experimental dose escalation trial design of tenecteplase that has     demonstrated initial safety trends in a Phase I acute ischemic stroke trial. The initial dose     is 0.1 mg/kg IV and will increase to 0.2 mg/kg, 0.3 mg/kg, with a final cohort of patients     receiving 0.4 mg/kg. Drug administration will be a single dose bolus in each cohort.     Advancement of dose will occur if safety is not in question in the previous cohort. We hope     this will provide an acceptable benefit risk ratio as the mortality of ARDS is approximately     30 - 60%. All patients will be closely monitored for any change in clotting parameters and     signs of bleeding. Tenecteplase will be administered via a peripheral IV as described in the     package insert.   "
197962|NCT00431392|"     There is evidence from a variety of animal studies that choroidal blood flow is under neural     control. By contrast, only little information is available from human studies. Recent results     indicate that a light/dark transition is associated with a short lasting reduction in     choroidal blood flow. We have shown that during unilateral dark/light transition both eyes     react with choroidal vasoconstriction strongly indicating a neural mechanism.      The present studies investigate this possibility by using pharmacological interventions. The     pharmacological agents tested include a nitric oxide synthase inhibitor, an alpha-receptor     agonist (as a control substance for the blood pressure increasing nitric oxide synthase     inhibitor), a muscarinic receptor blocker, and a non-specific beta-blocker. These drugs were     chosen on the basis of previous animal experiments, as the systems, which are specifically     influenced by these substances, are likely involved in neural control of choroidal blood     flow.   "
197975|NCT00437606|"     This study will investigate the effect of hepatic impairment on the pharmacokinetics,     pharmacodynamics, safety and tolerability of GK Activator (2) in type 2 diabetes patients     with mild and moderate hepatic impairment. Patients with type 2 diabetes, and with normal     hepatic function, or mild or moderate hepatic impairment, will receive a single dose of GK     Activator (2) 100mg po before breakfast, for assessment of pharmacokinetic, pharmacodynamic     and safety parameters. The anticipated time on study treatment is <3 months, and the target     sample size is <100 individuals.   "
197973|NCT00437580|"     This study aims to reduce the duration of VRE intestinal carriage by the administration of     Lactobacillus casei rhamnosus (strain Lcr 35 LC). Patients will be blindly randomized to be     assigned to a 5 weeks regimen with the probiotic (10 9 lactobacillus bid) or to a 5 weeks     regimen with placebo.A stool culture will be performed every week for 5 weeks (during the     administration of treatment) then every two weeks until 3 consecutive negative stool culture     for VRE.   "
197976|NCT00437619|"     This single arm study will evaluate the efficacy and safety of sequential treatment with     Diavobet (betamethasone propionate 0.5mg/g plus calcipotriol hydrate 50 micrograms/g) once     daily for 4 weeks followed by Daivonex (calcipotriol hydrate 50 micrograms/g) twice daily for     4 weeks, in the control of signs and symptoms in patients with mild to moderate psoriasis.     Only patients showing a >50% response to Daivobet will progress to the Daivonex maintenance     phase. The anticipated time on study treatment is <3 months, and the target sample size is     100-500 individuals.   "
200853|NCT00478478|"     Post-Market Registry on Use of Merci Retrieval System. Primary data to be collected will     include:        -  Post-procedure revascularization success        -  90-day mRS 0-2        -  90-day mortality   "
197963|NCT00431405|"     Rheumatoid arthritis (RA) is a symmetric, peripheral polyarthritis of uncertain etiology that     can lead to joint deformity and destruction. However, the effects of RA are not confined     simply to joint involvement. Virtually every organ system can be affected by RA if left     untreated. Of particular note is RA’s affect on the cardiovascular system. RA patients have a     reduced lifespan compared to the general population primarily due to an increased     cardiovascular disease burden (1). Recently, RA has been linked to the development of     preclinical atherosclerosis in the carotid arteries as measured by ultrasonography (2). Women     with RA have also been shown to have an increased incidence of nonfatal myocardial     infarctions (3). Despite these studies showing the effects of RA on the cardiovascular     disease burden of those who are afflicted, no study to date has compared the number of     cardiovascular events in a large RA patient population to a risk factor and age matched     control group. Consequently it is the goal of this study to determine whether the     cardiovascular event ratio in an RA patient cohort exceeds an age and risk factor matched     cohort of non-RA patients. This study will also attempt to ascertain whether specific     cardiovascular risk factors contribute to the cardiovascular morbidity and mortality     associated with RA and if any standard cardiovascular medicines disproportionately contribute     to patient outcome.      Hypothesis: Given the increased cardiovascular disease burden associated with RA patients     they are likely to suffer from a statistically significant increased risk of cardiovascular     events when compared to an age and risk factor matched cohort.   "
197964|NCT00431418|"     The purpose of this pilot study is to investigate in a randomised double-blind trial whether     treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at     28 weeks of gestation or less.   "
197965|NCT00431431|"     Both tibolone and raloxifene have been demonstrated to prevent postmenopausal bone loss.     During treatment with tibolone bone mineral density (BMD) of the spine has been shown to be     increased between 1.8 and 5.8 % above baseline in two years, depending on the population     studied. Since treatments aimed at prevention should ideally be used long-term, compliance     with the treatment is crucial. Efficacy of and compliance with the two treatments will be     measured and evaluated.   "
197966|NCT00431444|"     This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone     turnover markers in postmenopausal women with low bone mineral density over 6 months.   "
197967|NCT00431457|"     Patients will be prospectively randomized to 3 different treatment arms:        -  Treatment group 1: patients who undergo medial temporal lobe resection        -  Treatment group 2: patients who receive immediate hippocampal neurostimulation        -  Treatment group 3: patients who are implanted with an intracranial electrode but in whom          hippocampal neurostimulation is delayed for 6 months.      Twelve months after inclusion unblinding will occur. Patients in group 2 and 3 will have the     option to choose between continuing neurostimulation treatment or resective surgery.      Study visits will occur every 3 months.   "
197968|NCT00437502|"     This study will evaluate the safety of administering a peptide vaccine consisting of twelve     different tumor-rejection antigens known to be present on ovarian tumor cells. The vaccine is     designed to elicit immune responses against twelve different pathways that are essential to     tumor growth, survival and metastasis.HLA-A2+ is a required criteria for subject eligibility.   "
197969|NCT00437528|"     A novel sensor (a device named sensurine)was developed in the aim of real- time measurement     of bladder volume. The sensurine device is a wearable, fully passive, non-invasive and     compact heat flow sensor (patent pending) and electronic control unit. The device will serve     as a tool for managing and treating bladder dysfunction (by behavioral treatment), such as     overactive bladder without incontinence, urge incontinence and voiding difficulties. In this     phase I of the clinical trial the sensor unit will be tested for technological feasibility     demonstration and for collecting design data.   "
197970|NCT00437541|"     In six communities we will seek out households where someone who has a history of respiratory     problems. For the first winter we will measure temperature and humidity of the house and     health of occupants. We will insulate half the houses and the next winter compare them with     the uninsulated houses to see if warmer houses improve health.   "
197971|NCT00437554|"     Primary:      To show the equivalence in terms of efficacy glycated hemoglobin (HbA1c) of     glimepiride/metformin slow-release combination tablet (Amaryl M SR 2/500) once daily compared     with fixed-dose glimepiride/metformin combination tablet (Amaryl M 1/250) twice a day on     HbA1c in patients with type 2 Diabetes Mellitus (DM)      Secondary: To compare the following parameters in two treatment arm        -  Efficacy; Fasting Plasma Glucose (FPG) and Post-prandial two hours plasma glucose (PP2h)        -  Response rates in terms of HbA1c, FPG        -  Patient compliance      Safety:        -  episodes of hypoglycemia        -  adverse events        -  laboratory values including hematology blood chemistry and urinalysis        -  vital sign and physical examination   "
197972|NCT00437567|"     Necrotizing enterocolitis (NEC) is the most common gastrointestinal catastrophe affecting     10-15% of premature neonates of <1500 gm. NEC is a disease of the immature intestine,     characterized by impaired mucosal barrier function leading to increased gut permeability. We     have previously demonstrated a protective effect of probiotic administration against the     development of NEC. Others have shown that prebiotics can stimulate natural production of     bifidobacteria and lactobacillus in the preterm gut. We have therefore hypothesized that     prophylactic administration of prebiotics would also provide protection against necrotizing     enterocolitis in the premature neonate, without the potential for sepsis which has been     reported on rare occasions with probiotics administration.   "
197974|NCT00437593|"     Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with     diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane     peeling with two different types of dyes.   "
201070|NCT00472888|"     This study is planned to investigate the incidence of intraoperative floppy iris and its     relationship with pseudoexfoliation, diabetes, hypertension as well as systemic alpha-1     adrenergic blocker use.   "
197978|NCT00437645|"     This study was designed to compare the efficacy, tolerability, and safety of the combination     valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension     not adequately controlled (defined as mean sitting systolic blood pressure [msSBP] ≥ 130 mmHg     and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and     tolerability of the treatments by providing data that assessed blood pressure and the     proportion of patients developing peripheral edema.   "
197979|NCT00437658|"     This study is designed to see how a research compound (NBI-56418) works compared to DMPA-SC     (also known as depo-provera) in women with endometriosis and to see how both may affect bone     mineral density.   "
197980|NCT00437671|"     The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when     Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given     concurrently with strict control on the anatomical location and timing of administration of     TIG and TT. Pharmacokinetic profile of antibody titer including the duration of adequate     titer protection provided by TIG and TT given in combination will be assessed using a     standardized administration regimen and standardized antibody assay procedure. This study may     provide evidence for the recommendations of the World Health Organisation (WHO) whereby dual     coverage with both a vaccine and tetanus hyperimmune would ideally provide the best coverage     for anyone with the potential of developing tetanus.   "
197981|NCT00437684|"     The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV     drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN     + ritonavir in HIV/HCV coinfected patients.      Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with     HIV efficacy versus optimized HAART.   "
197982|NCT00437697|"     Intensive care patients are at high risk to develop deep venous thrombosis and pulmonary     embolism. Despite anticoagulation with heparin 7% of ICU patients suffer from this serious     complication. Optimal regimens for prevention of VTE have been established in medical     patients only and are not known for ICU patients.      It was therefore the aim of this study to compare the bioavailability of a low molecular     weight heparin in ICU patients and in medical patients. Furthermore, we looked wether a 50%     dose increase resulted in better bioavailability of this drug.   "
197983|NCT00437710|"     We will study in a prospective randomised fashion 50 patients who will be treated by     intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition     to standard therapy after MI or standard therapy.      After standard therapy for acute MI, 10 patients were transplanted with autologous     mononuclear BMCs via a balloon catheter placed into the infarct-related artery during balloon     dilatation (percutaneous transluminal coronary angioplasty). Another 10 patients with acute     MI were treated by standard therapy alone. After   "
197984|NCT00437723|"     This 2 arm study will compare the level of anemia, and the decline in renal function, between     patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney     disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving     NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of     120-135 g/L), or to a control group not receiving NeoRecormon. The anticipated time on study     treatment is 3-12 months, and the target sample size is <100 individuals.   "
197985|NCT00437736|"     Two-centre, open label, uncontrolled, dose-finding phase I study, to determine the safety and     tolerability of APO010 administered by intravenous bolus injection once per week. It will be     the first time this agent will be administered to humans. At lower dose levels, the first     cycle duration is 7 weeks. In subsequent cycles, APO010 is administered as 4 weekly doses     followed by a two-week drug rest, cycle duration is 6 weeks. Based on preclinical studies of     APO010 may cause liver toxicity and a drop in platelets, that recover within 5 days. The main     aim of the study is to identify the recommended dose of APO010 for future clinical studies of     APO010.   "
197986|NCT00437749|"     Multiple Drug Resistance is the phenomena whereby cells become resistant to a variety of     drugs with different mechanisms of action. Drug resistance remains a significant impediment     to successful cancer chemotherapy inhibitors have been developed and are currently in     clinical trials. CBT-1 is a natural product currently in clinical trials as an inhibitor   "
197987|NCT00437762|"     Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we     need more studies. The purpose of the study is to compare the effectiveness of botulinum     toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical     care performed during 6 months. Method : It is a double blind randomized controlled trial.     Principal criteria of assessment is Pain intensity three months after injection.   "
197988|NCT00437775|"     Proteinuria is an expression of diabetic nephropaty in type 1 and type 2 patients.     Hypertenshion treatment and decreasing urine protein excretion, slow down renal     deterioration. Treating diabetic ,hypertensive patients with Angiotensin Converting Enzyme     inhibitors (ACEi), Angiotensin receptor blockers (ARBs)is common practice. The aim of our     work is to examine 1.The prevalence of ACE and ARB treatment in diabetic patients with or     without hypertension.2. Adverse drug reactions of ACEi and ARBs alone or in combination.   "
197989|NCT00437788|"     Whenever a scan is accessed through the PACS system a scanned document or digital picture may     be displayed automatically. In this study the technician will take a digital picture of the     patient who will be undergoing the CT scan. This way the radiologist will be able to view the     patient's face before viewing the scan.      The hypothesis is that viewing a digital picture of the patient before viewing the CT scan     will improve the quality of diagnosis.   "
198003|NCT00439036|"     The purpose of this study is to develop an opiate detoxification behavior therapy based on     current Acceptance and Commitment Therapy (ACT) theory and method, and to test its     feasibility and promise in the context of voluntary methadone detoxification.   "
197990|NCT00437814|"     Objectives: Ketamine is an effective, short-acting anesthetic drug, which does not decrease     blood pressure. It is widely stated that Ketamine increases intracranial pressure (ICP),     which prevents its use in many emergency situations, specifically in patients with traumatic     brain injury (TBI) and with increased ICP. Based on previous clinical experience, we     hypothesized that Ketamine decreases – rather than increases – ICP.      Methods: Prospective, controlled, clinical trial. Children with ICP monitoring will receive a     single Ketamine dose (1-1.5 mg/kg) either for increased ICP and/or before a potentially     distressing activity. Hemodynamic variables, ICP and cerebral perfusion pressure (CPP) will     be recorded 1 minute before and every minute for 10 minutes following Ketamine administration     (Before/after design).   "
197991|NCT00437827|"     This study is testing a process (rEEG)for selecting the most appropriate medication(s) to     treat a patient's depression versus a control group being treated according to a standardized     method, the modified Star*D Algorithm. Qualified subjects will be randomized to the     experimental (rEEG guided) group, or the control group and treated for 12 weeks. Medications     utilized in this study are currently marketed. All visits, physical exam, rEEG, labs, rating     scales and medications are provided at no cost to the patient.   "
197992|NCT00437840|"     GSK598809 is being developed to facilitate overcoming an addiction to nicotine and to help     people stop smoking. This study will investigate if GSK598809 is safe and tolerated in people     who smoke and will also look at blood levels of GSK598809 and nicotine.   "
197993|NCT00437853|"     EFFICACY OF NEOADJUVANT ENDOCRINE THERAPY WITH ANASTROZOLE IN POMENOPAUSAL WOMEN WITH     ER-POSITIVE BREAST CANCER.      Flavia Morales-Vásquez, Horacio Noé López Basave.      Background: Neoadjuvant Hormonal Therapy (HT) is being used increasingly to downstage locally     advanced and large operable breast cancer. Following this treatment, inoperable breast cancer     often becomes fully respectable and tumors requiring mastectomy may be successfully removed     by breast-conserving surgery (BCS).      Methods: Recruit postmenopausal women with ER(+) and/or PgR (+) breast cancer (BC) T2,N1-2 to     T3,N0-1 were assigned to HT with anastrozole 1 mgr daily for 4 months.      The primary endpoint was to compare overall objective response (OR) determined by clinical     (palpation) and ultrasound. Secondary endpoint was the number of patients who qualified for     BCS plus radiotherapy.   "
197994|NCT00438906|"     The purpose of this study is to find the best and most sensitive screening modality (CT, MRI,     EUS)for very small pre-cancerous pancreatic lesions and to treat these small lesions before     they turn into cancer. Another purpose of this study is to search for common markers on DNA     that would increase the chance of someone developing pancreatic cancer, and locate proteins     in pancreatic juice that indicate tumor development.   "
197995|NCT00438919|"     This multicenter, prospective, observational registry will evaluate the safety and     performance of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, and of all future     generation of commercially approved Cordis Sirolimus-eluting Stents (SES), in routine     clinical practice. Its objective is to measure the incidence and identify the predictors of     acute, sub-acute and late stent thrombosis and Major Adverse Cardiac Events (MACE).     Additional analyses will be performed in patient sub-populations, such as diabetes, in-stent     restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.   "
197996|NCT00438932|"     The purpose of this study is to learn more about how the kidneys control the blood levels of     phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this     information to design improved treatment strategies for phosphorus-related problems for the     millions of patients with chronic kidney disease.   "
197997|NCT00438945|"     We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan     reduces the activity of the sympathetic nervous system in patients with essential     hypertension - during baseline conditions and after activation of the sympathetic nervous     system.   "
197998|NCT00438958|"     RATIONALE: Giving chemotherapy before a donor peripheral stem cell transplant or bone marrow     transplant using stem cells from a brother or sister that closely match the patient's stem     cells, helps stop the growth of cancer or abnormal cells. It also helps stop the patient's     immune system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune cells and help destroy any remaining cancer or abnormal cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving colony-stimulating factors, such as     G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can     be collected and stored. Giving methotrexate and cyclosporine before and after transplant may     stop this from happening. It is not yet known whether a donor peripheral stem cell transplant     is more effective than a donor bone marrow transplant in treating hematologic cancers or     other diseases.      PURPOSE: This randomized phase III trial is studying filgrastim-mobilized sibling donor     peripheral stem cell transplant to see how well it works compared with sibling donor bone     marrow transplant in treating patients with hematologic cancers or other diseases.   "
197999|NCT00438971|"     The purpose of this study is to determine whether duloxetine is effective in the treatment of     panic disorder.   "
198000|NCT00438984|"     RATIONALE: Biological therapies, such as therapeutic autologous lymphocytes, may stimulate     the immune system in different ways and stop tumor cells from growing. Drugs used in     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may     also stimulate the immune system in different ways and stop tumor cells from growing.     Aldesleukin may stimulate white blood cells to kill tumor cells. Giving therapeutic     autologous lymphocytes together with cyclophosphamide and aldesleukin may be an effective     treatment for melanoma.      PURPOSE: This phase I trial is studying the side effects of giving therapeutic autologous     lymphocytes together with cyclophosphamide and aldesleukin in treating patients with stage IV     melanoma   "
198001|NCT00439010|"     The underlying goal of this study is to assess 123-I AV39 SPECT imaging as a tool to detect     ß-amyloid deposition in the brain of AD research participants and age- and gender-matched     healthy subjects.   "
198002|NCT00439023|"     The purposes are        1. to measure the effect of dialysis with glucose on blood pressure, pulse rate, plasma          concentration of glucose, plasma concentrations of glucagon, growth hormone, renin,          angiotensin II, endothelin and body temperature, and        2. to analysis the relationship between changes in blood pressure on the one hand and          changes in vasoactive hormones on the other   "
198004|NCT00439049|"     The overarching goal of this project is to have a consolidated consent and evaluation     procedure that will lead potential subjects to the most appropriate clinical trial or human     laboratory study (and its consent process) for their presenting concerns or interests. A     second purpose is to have a consolidated intake data base on which secondary analyses can be     conducted.   "
198008|NCT00439101|"     The purpose of this research study is to determine if megestrol acetate can be used as an     appetite stimulant to improve weight gain in children with cancer and poor nutrition. The     study design is a randomized, double blind, placebo controlled trial. Secondarily, we would     like to determine what effect any improvement in weight has on body composition by DEXA scan.     This includes whether the drug results in an increase in fat, fat-free mass, or both. If our     patients gain weight we would like to know if it improves their quality of life. Finally,     many children with cancer lose too much weight and require feeding to occur through a tube     put down their nose into their stomach (NG feeding). The tube can be painful to put down and     is uncomfortable when in. Some children may also require nutrition to be given into a vein     (Total Parenteral Nutrition or TPN). We are trying to see if we can prevent these procedures     from happening by having the subjects gain weight. This study will tell doctors if the drug     truly works (or does not work) in children who are underweight.   "
198009|NCT00439114|"     This study is planned to compare the results of ultrasonic and Orbscan pachymetry in corneal     haze not related to surgery. Corneal haze is graded with slit-lamp by a single examiner.     Ultrasonic and Orbscan II pachymetry measurements are obtained. Paired t and Kruskal-Wallis     tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry     measurements. Correlation of the two methods and haze grade is determined with Kendall’s     tau-b correlation analysis.   "
198010|NCT00439127|"     Thyroidectomy followed by administration of large activities of 131-iodine (131I) is the     treatment of choice for differentiated thyroid carcinoma (DTC). The serum thyroglobulin (Tg)     measurement during hypothyroidism (offT4-Tg), just before radioiodine thyroid ablation, has     proved to be effective for predicting persistent/recurrent disease. However, the Tg     measurement cannot be used as a corresponding value for preablative offT4-Tg when rhTSH is     used as stimulous before treatment. The present study was undertaken to evaluate if     post-thyroidectomy Tg values, measured before rhTSH-stimulation and radioiodine     administration, is of prognostic value in patients affected by DTC. We enrolled 28 patients     with DTC and submitted to total thyroidectomy. Thyroxine (T4) treatment was started just     after surgery to suppress TSH levels. Six to nine weeks later Tg levels were measured both     basally (onT4-Tg) and after rhTSH (rhTSH-Tg) stimulation. Subsequently, T4 was stopped and     serum Tg measured (offT4-Tg) just before 3700 MBq of 131I-iodide administration. A     post-treatment whole body scan (PT-WBS) was performed and neck radioiodine uptake (RAIU)     measured. A significant relationship was found between onT4-Tg and both rhTSH-Tg and     offT4-Tg. The onT4-Tg levels of 0.2 ng/mL or higher predicted PT-WBS results with a 100%     negative and 43% positive predictive values, respectively. Additionally onT4-Tg levels of 0.9     ng/mL or more predicts 12-months recurrences with 100% negative and 60% positive predictive     value. In comparison, 1.0 ng/mL or higher offT4-Tg values predicted PT-WBS results and     12-months restaging with 94% and 100% negative and 45% and 27% positive predictive value,     respectively. Basing on our data we conclude that preablative onT4-Tg may be of value as     prognostic marker when rhTSH-aided radioiodine ablation is done. Additionally, the role of     preblative onT4-Tg measurement as a yard-stick for radioiodine ablation should be further     evaluate.   "
198011|NCT00439140|"     This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of     urinary incontinence overactive bladder in patients with a spinal cord injury or multiple     sclerosis.   "
198012|NCT00439153|"     Tourniquet cuffs are routinely used to stop blood flow in patients' arms or legs during     surgery. This allows surgeons to better visualize anatomical structures during the procedure.     Although complications after surgery are rare, patients sometimes suffer from pain or     numbness in their limb and redness of the skin in the area where the cuff was applied. Using     the lowest pressure possible minimizes the chance of these problems. Previous studies,     conducted on adults, have shown that basing the cuff pressure on the minimum amount of     pressure necessary to stop blood flow to the limb (known as limb occlusion pressure, or LOP)     can lead to lower cuff pressures successfully being used. The goal of this study is to     determine the magnitude by which tourniquet cuff pressure can be reduced in children using a     tourniquet instrument capable of measuring LOP in combination with tourniquet cuffs selected     to fit the size and contour of the limb. The tourniquet instrument and cuffs used in this     study are all commercially available and approved for use with children.      Hypothesis:      It is hypothesized that use of a commercially available tourniquet instrument capable of     calculating limb occlusion pressure in combination with tourniquet cuffs selected and applied     according to a standardized procedure will produce surgical fields of equal or superior     quality with significantly lower tourniquet cuff pressures.   "
198013|NCT00439166|"     This study will determine if biomarkers found in the cerebrospinal fluid of people with     Alzheimer's disease, are affected by treatment with two common antibiotics, doxycycline and     rifampicin, suggesting a disease-modifying effect of those treatments.   "
198014|NCT00439179|"     A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary     Cancer Schema   "
198015|NCT00439192|"     This study is designed to determine the efficacy of escalating doses of ELB245 versus placebo     , when administered to patients with OAB and to compare the efficacy of escalating doses of     ELB245 versus the standard treatment tolterodine, when administered to patients with OAB.   "
198016|NCT00439205|"     The goal of this clinical research study is to evaluate an imaging technology that may help     clinicians see how far an area of pre-cancerous or cancerous tissue extends in the mouth.   "
198017|NCT00439218|"     The purpose of this study is to identify the maximum tolerated dosage of sodium     phenylbutyrate in children with spinal muscular atrophy type I; and to determine if the drug     has an effect on SMN mRNA and protein levels.   "
198018|NCT00439231|"     This study will evaluate the safety and effectiveness of a new drug called lenalidomide     (Revlimid) for treating patients with chronic lymphocytic leukemia (CLL) and small     lymphocytic lymphoma (SLL) who relapsed after their initial treatment.      Patients 21 years of age and older with CLL or SLL who have previously received standard     treatment may be eligible for this study.      Participants take lenalidomide capsules once a day for 21 days, followed by 21 days off the     drug. This constitutes one treatment cycle. Treatment continues for four cycles as long as     the medicine is tolerated. After four cycles, patients who respond completely continue     treatment for another two cycles; patients who respond partially continue treatment for     another four cycles; and patients who do not respond stop treatment but continue to be     followed for safety.   "
198019|NCT00439244|"     The purpose of this study is to assess the effects of zoledronic acid administered at the     same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone     mineral density (BMD) gain in the lumbar spine and total hip   "
198107|NCT00440388|"     This is a phase II clinical trial in patients who have not received systemic treatment for     follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this     disease, with AT-101, an experimental drug. The hypothesis is that by adding AT-101 to the     rituximab regimen, improvement to patients' response to the treatment will be observed verses     rituximab alone.   "
198020|NCT00439257|"     The treatment of multiple sclerosis was evolving in light of specific drug therapies to treat     the disease, refinements and acceptance of imaging with MRI to diagnose and monitor the     disease process, and progress in understanding the pathogenesis of the inflammatory     demyelinating process. The result was to raise new issues in the treatment of the disease,     which are then being addressed by studies, including when to initiate treatment and the     treatment of partial responders to existing therapies. Paralleling strides in treatment, and     of particular importance to the Veterans Administration, was the effectiveness of such     therapies, both in terms of cost to the VA Health Care System and quality of life of veterans     with multiple sclerosis. This study addressed these issues.   "
198021|NCT00439270|"     The purpose of this study is to find the recommended doses of dasatinib and docetaxel given     in combination to men with metastatic hormone refractory prostate cancer and to assess the     pharmacokinetic interactions between the 2 drugs.   "
198022|NCT00439283|"     Continuous treatment with the anti-tumor necrosis factor alpha monoclonal antibody infliximab     is efficacious in ankylosing spondylitis (AS), whereas treatment discontinuation results in     disease relapse, with variable delay. Objective of this study was to compare efficacy between     a continuous treatment with infliximab, and a treatment adapted to symptoms recurrence.     Addition of methotrexate (MTX)to infliximab was also tested.   "
198023|NCT00439296|"     This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott     Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic     leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done     to find the highest dose of ABT-751 that can be given safely in combination with other     chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects.     After a safe dose for ABT-751 given with chemotherapy has been found, the study will add     additional patients to find out if ABT-751 (given at the maximal safe dose) when given with     additional chemotherapy is an effective therapy for the treatment of children with relapsed     ALL. It is expected that approximately 15-35 children and young adults will take part in this     study.   "
198024|NCT00439309|"     To evaluate a new vascular sealant compared to control for the control of suture line     bleeding after vascular reconstructive surgery.   "
198025|NCT00439322|"     Posttraumatic stress disorder (PTSD) occurs in response to an extreme traumatic stressor. It     is estimated that as many as 1 million VA patients who were exposed to combat may have PTSD.     VA patients with PTSD recently have been designated as a �Special Emphasis� population for     which health care resources are allocated at approximately 14 times those allocated to     patients without such chronic, complex, and intensive health care needs (i.e., �Basic Care�     groups). Despite recognition of its substantial impact upon VA resources, the extent and     means by which PTSD affects health and health care use remain unclear. This study seeks to     enhance understanding of both the extent and means by which PTSD affects the health and the     health care use of patients in VA ambulatory care. To meet this goal, we build on an ongoing     HSR&D project, the Veterans Health Study (VHS), a prospective longitudinal study of 2,425 VA     ambulatory care patients.   "
198026|NCT00439335|"     This study will compare the influenza A/H5N1 virus vaccine given by injection in the muscle     versus injection in the skin in healthy adults. The study will look at the safety of the     injections, how the body reacts, and what the body's immune response does when the vaccine is     given in the muscle versus in the skin. The study will look at 226 healthy volunteers, ages     18-49 years old. Study procedures will include getting 2 doses of vaccine 28 days apart,     physical exams, follow-up clinic visits to check the places on the body where each vaccine     was given, and blood sample collections. Volunteers will complete a memory aid by writing     down temperatures and health changes for 7 days after each vaccination. Volunteers will be     involved in the study for up to 241 days.   "
198027|NCT00439348|"     There are several benefits of over-the-counter medications, yet there is little research     evaluating how to increase patient compliance when a health care provider suggests an     over-the-counter (OTC) medication. We are evaluating two types of physician directions to see     which increases patient compliance with OTC medications.   "
198028|NCT00439361|"     Primary Objectives:        1. To determine the toxicity profile of multiple doses of bortezomib when given with ICE in          patients with relapsed and refractory classical Hodgkin lymphoma (HL).        2. To determine the maximum tolerated dose (MTD) of bortezomib when given in combination          with ICE chemotherapy in patients with relapsed and refractory classical Hodgkin          lymphoma (HL).      Secondary Objectives:      - To determine the overall response rate and complete response rate in patients with relapsed     and refractory classical Hodgkin lymphoma (HL).   "
198029|NCT00439374|"     The purpose of this study is to see if giving progesterone medication to pregnant women, who     have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers     the risk of early delivery and improves the health of their baby.   "
198042|NCT00439543|"     Idiopathic pulmonary fibrosis(IPF) is chronic progressive fibrosing lung disease of unknown     cause. There is no effective therapy yet for this disease and the mean survival in most     reports is about 3 years after the diagnosis. Because of the stiff fibrosis of the lung,     pulmonary hypertension is the late complication of IPF and its development heralds a very     poor outcome of the patients. For the primary pulmonary hypertension, recently the effective     drugs have been available. However, there is no study about the efficacy of these drugs in     the patients with pulmonary hypertension secondary to pulmnary fibrosis, and the aim of this     trial is to study the safty and efficacy of Iloprost, one of the safe and effective drugs     in primary pulmonary hypertension.   "
198043|NCT00439556|"     The goal of this clinical research study is to find the highest tolerable dose of Velcade     (bortezomib) that can be given with BEAM (carmustine, etoposide, cytarabine and melphalan)     and rituximab in patients with lymphoma who receive a stem cell transplant.   "
198030|NCT00439387|"     This study will investigate the role that a brain chemical called serotonin plays in     seizures. Serotonin, present naturally in the brain, helps transmit signals between nerve     cells. Glucose is a sugar that is the main fuel of the brain. Studying these two chemicals     may help explain why people with epilepsy get seizures and are more likely to be depressed.      Healthy volunteers and patients 18 to 60 years of age who have epilepsy with or without     depression and whose seizures are not controlled by medication may be eligible for this     study. Candidates are screened with a review of their medical history, a physical examination     and an electroencephalogram (EEG, brain wave recording).      Participants undergo the following procedures:        -  Positron emission tomography (PET) scans: The first of three PET scans measures brain          blood flow and the activity at some of the brain serotonin receptors (the parts of brain          cells to which serotonin attaches). A second scan measures the amount of serotonin          transported between brain cells. A third scan measures glucose use. The PET scanner is          shaped like a doughnut. The subject lies on a bed that slides in and out of the scanner          with his or her head inside the opening. A special mask is fitted to the subject s head          to help keep it still during the procedure so the images will be clear. For the first          scan, catheters (plastic tubes) are placed in an arm vein to inject a radioactive          substance and in an artery in the wrist to collect blood samples. The other two scans          require only the catheter in the arm.        -  Magnetic resonance imaging: This test uses a strong magnetic field and radio waves to          obtain images of the brain. The scanner is a metal cylinder surrounded by a strong          magnetic field. The subject lies on a table that can slide in and out of the cylinder.          Most scans last between 45 and 90 minutes. Subjects wear earplugs to muffle loud          knocking noises that occur during scanning.        -  Psychological evaluation: Subjects are interviewed and fill out questionnaires to help          study sadness and depression in epilepsy.        -  Blood draw: Blood tests look for differences in genes between people with epilepsy who          are depressed and those who are not.   "
198031|NCT00439400|"     The objective of this study is to assess the safety and efficacy of doxycycline 0.025%     (ALTY-0501) ophthalmic solution for the treatment of dry eye using the Controlled Adverse     Environment (CAE) Model.   "
198033|NCT00439426|"     This single arm study will assess the efficacy and safety of Xeloda + oxaliplatin when given     as first line treatment for patients with metastatic nasopharyngeal cancer. Patients will     receive Xeloda (1000mg/m2 bid orally from day 1 to day 14, followed by a rest period of 7     days) plus oxaliplatin (130mg/m2 iv infusion on day 1 of each 21 day cycle) for 6-8 cycles.     The anticipated time on study treatment is until disease progression, and the target sample     size is <100 individuals.   "
198034|NCT00439439|"     Globus sensations are associated with gastroesophageal reflux disease as well as the presence     of a gastric inlet patch. No controlled trial exists on whether ablation of the cervical     heterotopic mucosa may lead to improvement of chronic globus sensations. The aim of this     sham-controlled trial is to clarify whether argon-beamer-ablation of cervical heterotopic     gastric inlet patches of the esophagus improves patients' chronic globus sensations.   "
198035|NCT00439452|"     Across the country, Community Health Centers are participating in the Health Disparities     Collaboratives sponsored by the Health Services Resources and Services Administration (HRSA).     The Health Disparities Collaboratives integrate three complementary conceptual frameworks: 1)     the Institute for Healthcare Improvement's (IHI) Breakthrough Series Model; 2) the     Improvement Model (i.e., Plan-Do-Study-Act cycles); and 3) Wagner's Chronic Care Model. The     Chronic Care model uses patient self-management, delivery system re-design, decision support,     and clinical information systems to maximize the effectiveness of interactions between     prepared proactive care teams and informed activated patients with chronic illnesses such as     diabetes, asthma, and depression. The Chronic Care model for depression, also known as     Collaborative Care, involves primary care providers working with a depression care team     comprising non-physicians (e.g., nurses, pharmacists) and mental health specialists (e.g.,     psychiatrists). Practice-based collaborative care involves primary care providers working     with an on-site depression care team. In contrast, telemedicine-based collaborative care     involves primary care providers working with an off-site depression care team using     telemedicine technologies. The purpose of this research project is to compare the     effectiveness and cost effectiveness of practice-based and telemedicine-based collaborative     care in Community Health Centers (without on-site mental health specialists) implementing the     Health Disparities Collaborative for depression.   "
198036|NCT00439465|"     The purpose of this study is to determine whether the administration of highly effective     killer cells (cytotoxic T cells), along with IL-2 and GM-CSF immediately following     Autologous Peripheral Blood Stem Cell Transplantation (APBSCT) will enhance anti-tumor immune     reconstitution and improve outcome of Multiple Myeloma patients.      The overall hypothesis of this proposal is that immediately following APBSCT the immune     reconstitution is optimal to administer killer cells, combined with the administration of     IL-2 and GM-CSF.   "
198037|NCT00439478|"     We aim to assess the incidence of oral and dental adverse events after high-dose radioiodine     therapy for differentiated thyroid cancer.   "
198038|NCT00439491|"     The aim of the study was to investigate the relationship between insulin resistance and body     composition in relation to secterion and expression of adipocytokines. Obese subjects undergo     6 months hypocaloric diet and, before, during and at the end of the diet, plasma samples and     subcutaneous adipose tissue samples are obtained for subsequent analysis. In addition, body     composition and insulin resistance are measured before and during the diet.   "
198039|NCT00439504|"     The purpose of this study is to determine if there are significant cardiovascular or other     interactions between sublingual lobeline and intravenous methamphetamine.   "
198040|NCT00439517|"     This is an exploratory study to compare activity and safety in 400 patients with previously     untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT®     (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination     regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)   "
198041|NCT00439530|"     Pharmacologic Study of Oseltamivir in Healthy Volunteers is a Phase I study in which 8 to     32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens     within each of 4 visits. The study is being conducted at the Bangkok Hospital of Tropical     Diseases Research Unit, Faculty of Tropical Medicine, and commenced enrolling healthy     volunteers on 23 November 2006. The duration of the study is expected to be approximately     four months. The goals of this study are to assess the use of loading dose oseltamivir and     the concomitant use of probenecid and to characterize the pharmacokinetic properties of     oseltamivir in Thai subjects.   "
198044|NCT00439569|"     The purpose of this study is to identify the maximum tolerated dosage of sodium     phenylbutyrate in children with spinal muscular atrophy types II or III; and to determine if     the drug has an effect on SMN mRNA and protein levels.   "
201175|NCT00484133|"     The purpose of this study is to asses the recovery of organ failure between two resuscitation     protocols in severe sepsis: standard, pressure guided therapy versus a microcirculation     guided therapy   "
198058|NCT00439751|"     This is a prospective, multicentre, open-labelled, randomized controlled trial comparing the     efficacy of immediate versus deferred androgen deprivation therapy (ADT) using goserelin     (Zoladex®) in men with recurrent prostate cancer after radical radiotherapy.      1100 patients will be accrued from participating Canadian Urological Oncology Group sites in     an estimated time of 3 years. First analysis is planned for 7 years after study recruitment     is completed.   "
198059|NCT00439764|"     The primary purpose of this study is to assess the effectiveness of a brief educational     program and of an additional program in physical therapy, for the treatment of low back pain     in Primary Care of the Spanish National Health Service. This is a controlled, cluster     randomized community trial.   "
198045|NCT00439582|"     Background:      Detrimental effects of consumption of industrial trans fatty acids (TFA) from partially     hydrogenated vegetable oils (PHVO) on cardiovascular disease (CVD) risk factors are well     documented. However, very little information is available on the effect of natural sources of     TFA coming from milk fat, dairy products and ruminant meat. In fact, due to the naturally low     level of TFA in milk fat, it is almost impossible to conduct a clinical trial with a limited     number of subjects.      Methodology:      To compare the effects of industrial and natural dietary sources of TFA, two specific test     fats have been designed and produced. A substantial amount of milk fat (130 kg) enriched in     TFA has been produced by modification of the cow's diet and selection of cows with the     highest TFA content. The level obtained was approximately 4- to 7-fold higher than typically     present in milk fat ( - 20 instead of 3-6 g/100 g of total fatty acids). The control fat is     composed of PHVO balanced in saturated fatty acids (lauric, myristic and palmitic). Both     experimental fats contain about 20-22% of monounsaturated TFA and the volunteers' daily     experimental fat intake (54 g), will represent about 12.0 g/day of TFA or 5.4% of the daily     energy (based on 2000 kcal/day). These two test fats have been incorporated into food items     and will be provided to 46 healthy subjects under a randomised, double blind, controlled,     cross-over design. The primary outcome is high-density lipoprotein cholesterol (HDL-C), which     is an independent risk factor for CVD. Other parameters such as lipoprotein cholesterol     (LDL-C), very low-density lipoprotein cholesterol (VLDL-C), and HDL-C level and subclasses     will be also to be evaluated.   "
198046|NCT00439595|"     A high proportion of children under the age of 5 years and pregnant women in Tanzania is     anaemic, particularly in areas of high malaria transmission. The symptoms of anaemia are     often non-specific or absent and clinical judgement is generally insensitive in estimating Hb     levels, especially in infants who are assessed by basic grade health staff. Thus while     treatment for the common causes of anaemia is available, many cases are not treated due to     difficulties in recognising anaemia.      New diagnostic tools can increase the sensitivity of anaemia detection compared to clinical     diagnosis but no studies have demonstrated their effectiveness in increasing case-detection     and treatment of anaemic patients at the first level of healthcare. In addition, the costs of     their use in relation to any increase in numbers of cases treated are not known and this     knowledge is needed to guide public health decisions.      Two methods of measuring anaemia are currently suitable for use at the first level of care;     Copack Haemoglobin colour scale (HBCS) and Hemocue portable photometry. We propose to compare     the effectiveness in basic health facilities of these 2 simple diagnostic tools compared to     control dispensaries (current practice) in increasing rates of detection and treatment of     anaemia in children under the age of 5 years and pregnant women over the course of 1 year in     a cluster-randomised trial in 30 dispensaries in a malaria-endemic area of NE Tanzania.   "
198047|NCT00439608|"     Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction     and Gastric Cancer   "
198048|NCT00439621|"     The purpose of the study is to evaluate safety and efficacy of three doses and two dosing     regimens of RP01 as an anti-IgE immunotherapy in allergic patients.   "
198049|NCT00439634|"     AVE1625 is a new potent and selective cannabinoid 1 (CB1) antagonist in clinical development     for the treatment of cognitive impairment in patients diagnosed with schizophrenia.      The main objective of this study is to evaluate the efficacy on cognitive impairment of 3     doses of AVE1625 using a new cognitive battery called Measurement and Treatment Research to     Improve Cognition in Schizophrenia (MATRICS) in schizophrenic patients.      The secondary objectives are to measure the efficacy of AVE1625 on functional capacity of the     patients using a specific scale called University of California San Diego Performance-based     Skills Assessment 2 (UPSA2) and to assess the safety of the compound.   "
198050|NCT00439647|"     This study will investigate if the drug zoledronic acid given once yearly is safe and has     beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with     osteoporosis.   "
198051|NCT00439660|"     This study will be a Phase I, randomized, double blind, safety and immunogenicity trial of     the Vero cell based 116E neonatal rotavirus vaccine candidate strain in healthy     non-malnourished infants aged 8-20 weeks at three different dosage levels i.e.10^4.0, 10^5.0     and 10^6.0 FFU and for three administrations of each of these dosages given to infants at     4-week intervals. 180 infants (90 vaccinees/90 placebo) will be enrolled for each of the     three dosage levels. The progression from the lower to the next higher dosage will be based     on approval by the Data Safety Monitoring Board (DSMB) to be constituted by the Department of     Biotechnology, New Delhi.   "
198052|NCT00439673|"     The primary objective of the trial is to assess the activity of the combined use of Valproic     Acid (VPA)in combination with 5-Azacytidine (5-Aza C) in the treatment of MDS.      Activity will be evaluated as percentage of patients achieving complete or partial remission.   "
198053|NCT00439686|"     The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma.   "
198054|NCT00439699|"     The purpose of this study is to obtain information on whether or not the medication Memantine     reduces tremor in persons with essential tremor and is well-tolerated.   "
198055|NCT00439712|"     The purpose of this study is to show that in patients suffering from perennial allergic     rhinitis levocetirizine 5 mg OD relieves nasal obstruction. Furthermore the study is to     investigate how relevant for these patients their nasal obstruction and the effect of     levocetirizine on their nasal obstruction are.   "
198088|NCT00440141|"     Patients with glaucoma or ocular hypertension currently being treated with latanoprost     0.005%, and in need of additional IOP lowering will be randomized to receive either     brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost     0.005%   "
198056|NCT00439725|"     This is a multicenter, randomized, double-blind, placebo-controlled, event-driven,     superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein     thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with     rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension     study).   "
198057|NCT00439738|"     The purpose of this study is to compare the blood pressure lowering efficacy of     valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of     obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.   "
198060|NCT00439777|"     This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority     program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with     confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein     Thrombosis (DVT) (Einstein-PE).   "
198108|NCT00440401|"     To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery   "
198061|NCT00439790|"     The aim of this study is to analyze whether the sympathetic tone, measured indirectly and     directly by muscle sympathetic nerve activity recording, is elevated in patients with heart     failure receiving an appropriate shock from their implantable cardiac defibrillator (ICD)     compared to heart failure patients not receiving a shock from their ICD. All parameters     measured in this study will be used to build a risk algorithm able to identify heart failure     patients at high risk for sudden cardiac death who could receive an ICD.   "
198062|NCT00439803|"     AVX601, a bivalent alphavirus replicon vaccine expressing three CMV proteins (gB, pp65 and     IE1) is a candidate vaccine against cytomegalovirus (CMV).      The objectives of this Phase 1 study are to test the safety of the vaccine and the immune     response to the vaccine in healthy volunteers who have not previously been infected with CMV.     Volunteers will be assigned by randomization to receive either the vaccine or an inactive     substance (placebo) by injections in each arm on three occasions over 6 months. The study     will last 12 months and will have a total of 12 visits.   "
198063|NCT00439816|"     To determine racial/ethnic differences in preference for group visits in veterans with poorly     controlled hypertension (State 2 hypertension) and determine the effect of group visits on     health outcomes among veterans with poorly controlled hypertension.   "
198064|NCT00439829|"     The objective of the study is to elucidate the effect of synchronizing initiation of ovarian     stimulation treatment with follicular wave emergence in poor responder patients undergoing     IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle     will increase the number of follicles recruited and oocytes retrieved.   "
198065|NCT00439842|"     The purpose of this study is to help people with heart failure (HF) to manage their HF and to     prevent rehospitalizations. Another purpose is to test the usefulness of clinical     appointments and educational videotapes in teaching patients how to manage their HF.      It is proposed that the group clinic intervention (HFcareGroup)will reduce rehospitalization,     depression, and improve problem solving related to heart failure symptoms.   "
198066|NCT00439855|"     Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as     anticoagulation for PCI   "
198067|NCT00439868|"     This study will be conducted in healthy volunteers to investigate the effect on intraocular     pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day.   "
198068|NCT00439881|"     SB-681323 inhibits the action of an enzyme which is known to contribute to the inflammation     seen in such conditions as Chronic Obstructive Pulmonary Disease and Rheumatoid Arthritis.     This study will explore the safety of this drug and its blood levels when given in     intravenous form to healthy human volunteers.   "
198069|NCT00439894|"     Ancillary study to the Etanercept protocol 20060104. Subjects have been asked to provide     additional blood samples for further assessment.   "
198070|NCT00439907|"     Rupture of the external anal sphincter occurs in about 4% percent of deliveries. It is not     clear from other studies whether the results concerning anal function, e.g. fecal continence,     are better with the overlap repair or end-to-end repair of the injured muscle. The     researchers randomize women at birth to either overlap or end-to-end when the injury is     recognized, and examine them one year later with special anal physiologic examinations and a     validated questionnaire. The hypothesis is that the overlap technique is superior.   "
198071|NCT00439920|"     The present study aims at verifying the state of the art in what this illness concerns and at     organizing a centralized samples analysis.   "
198072|NCT00439933|"     Obesity in children and adolescents is associated with morphologic and functional changes of     the vascular wall, suggesting a potential role of juvenile obesity for the development of     atherosclerosis later in life. However, no evidence from intervention studies has been     provided so far that weight loss in obese children can improve vascular function. Therefore     we designed this study including a cohort of obese children before and after a structured     weight reduction program in order to answer the question, whether such an intervention can     improve vascular function and reverse destructive vascular changes.   "
198073|NCT00439946|"     The purpose of this 8-week study is to compare the effects of switching from intravenous     Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved     therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to     be mixed daily and is stable at room temperature, so there is no need for ice packs. In     addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every     8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication     pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a     smaller and lighter medication pump called the Crono Five infusion pump. This study will also     assess the effect that changing to Remodulin will have on treatment satisfaction and patient     quality of life.   "
198074|NCT00439959|"     This study represents the first administration of GSK625433 in humans. The study is designed     to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity     in Hepatitis C(HVC) infected adults. The way the human body processes GSK625433 will also be     investigated.   "
198089|NCT00440154|"     The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a     period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other     lipid plasma levels and the safety and tolerability of AVE5530.   "
198075|NCT00439972|"     The purpose of this study is to compare the effects of oral versus patch administration of     hormonal contraception on hormone sensitive proteins such as lipoproteins, clotting factors     and inflammatory proteins as well as blood sugar and insulin levels, antioxidant status and     flow-mediated dilation of arm and forearm vessels. The hypothesis is that oral administration     of contraceptive hormones will result in higher plasma levels of estrogen sensitive proteins     originating from the liver while patch administration of contraceptive hormones will result     in greater systemic effects of estrogen on vascular reactivity and antioxidant status.   "
198091|NCT00440180|"     Obesity is associated with an increase in blood levels of estrogen. Estrogen or female     hormone is believed to have a negative effect on sperm production. Aromatase inhibitors such     as anastrozole work to decrease the production of estrogen and increase testosterone in the     body. By decreasing the level of estrogen, sperm production should improve. In this study,     the investigators will try to determine the benefit of anastrozole in obese men and follow     pregnancy outcomes.   "
198092|NCT00440193|"     This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority     program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with     confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).   "
198076|NCT00439985|"     : Although intervention or prevention with young children with T1DM may help ameliorate     problems or forestall later problems in metabolic control, a number of potential barriers to     research have constrained the development of such interventions. To assess the feasibility of     intervening with young children and their families, we propose to conduct an exploratory     pilot study of a behavioral intervention for young children (ages 7 to 11) newly diagnosed     with T1DM. The intervention, derived from the pediatric prevention work of Seligman and his     colleagues, seeks to apply positive psychology principles to enhance optimism, self-efficacy,     and parent-child collaboration in diabetes management, in order to improve quality of life,     adherence, and metabolic control. This exploratory study will allow us to evaluate the     feasibility of intervening with young children and their caretakers and to estimate     intervention effect sizes in preparation for a randomized controlled clinical trial.   "
198077|NCT00439998|"     The efficacy of an epidural depends mainly on accurate placement of the catheter in the     epidural space. Therefore, identification of the epidural space is the most vital part of the     procedure. Obese patients represent the most challenging group for the identification of     anatomical landmarks. With the use of ultrasound, we can visualize the images of the     anatomical structures in the back. Some anesthesiologists believe ultrasound can help in the     placement of an epidural, and routinely use it to assist in determining needle entry point in     your back as well as estimating the depth at which the epidural space will be found. Our     hypothesis is that the use of lumbar spine ultrasound imaging will accurately determine the     epidural space depth and the epidural insertion point in obese patients.   "
198078|NCT00440011|"     Patients with glaucoma or ocular hypertension currently being treated with latanoprost     0.005%, and in need of additional IOP lowering, will be randomized to receive either     bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%   "
198079|NCT00440024|"     Sun-damaged skin, caused by chronic exposure to ultraviolet (UV) light, is characterized by     features such as wrinkling, uneven skin color, roughness and brown spots. An effective     treatment for sun-damage that is commonly prescribed is topical retinoic acid (RA). However,     the major drawback of topical RA use has been frequently observed irritation characterized by     redness, dry skin and severe itching. In this study, we examine whether a daily skin care     regimen comprised of an ultra mild cleanser and an effective moisturizer can help improve     tolerance to RA treatment.   "
198080|NCT00440037|"     The purpose of this study is to assess the safety and efficacy of long term dosing of AMG 531     in thrombocytopenic Japanese subjects with ITP.      It is anticipated that AMG 531 will be a safe and well tolerated in long term treatment and     that AMG 531 will effectively raise and maintain platelet counts to a desired therapeutic     range, when individual dose adjustments based on platelet counts are permitted.      This study is available to subjects who have completed any previous AMG 531 ITP study in     Japan and meet the eligibility criteria of this study.   "
198081|NCT00440050|"     The purpose of this study is to determine whether chronic DHA (Docosahexaenoic Acid)     supplementation slows the progression of cognitive and functional decline in mild to moderate     Alzheimer's disease (AD).   "
198082|NCT00440063|"     This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in     the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and     effective as 4 weekly monitoring. Patients with chronic kidney disease will receive     NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will     be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters,     either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the     target sample size is 100-500 inidividuals.   "
198083|NCT00440076|"     This is a four-center open-label study designed to determine activity of Velcade in     Myelodysplastic Syndrome (MDS) patients. A total of 28 subjects will be enrolled. The     patients will be registered to GIMEMA Data Center before therapy starts and after inclusion     criteria verification.   "
198084|NCT00440089|"     This randomized controlled trial examines the efficacy of hands-on-healing for fatigue and     immune function in breast cancer survivors. Participants may be randomized to one of three     groups: hands-on-healing, touch alone, or a control group.   "
198085|NCT00440102|"     The expected benefit is a reduction of the morbidity of patients admitted in the intensive     care unit having received ketamine for intubation.   "
198086|NCT00440115|"     The primary aim of this study is to assess the effectiveness of both high and low intensity,     disease management programs for smoking. The hypotheses are to compare abstinence from     cigarettes, the number of quit attempts, and smokers motivation at 24 months between     participants receiving high and low intensity disease management and those receiving usual     care.   "
198087|NCT00440128|"     The purpose of the study is to evaluate the effect of the study drug (GW679769) on a commonly     used chemotherapy drug (docetaxel) which will be given I.V. Blood samples will be taken to     see if the GW679769 alters the blood levels of the chemotherapy. The study will last about 2     weeks with a final follow-up visit 6 weeks later.   "
198090|NCT00440167|"     This crossover trial is performed in advanced and metastatic pancreatic cancer not previously     exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to     an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to     incorporate second-line treatment into the study design. Patient who fail on first-line     therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore     not only compares two different regimens of first-line treatment, it also compares two     sequential treatment strategies.   "
198093|NCT00440206|"     Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral     therapy.   "
198094|NCT00440219|"     This study aims to determine if a short course of oral prednisone helps to improve the     operative field and ease of surgery by minimizing bleeding during nasal polypectomy surgery.   "
198095|NCT00440232|"     We are testing the hypothesis that subjects in the treatment group will experience fewer     fasting induced headaches as compared to those in the placebo group.In our clinical     experience, we estimate that approximately 25% of our headache population experiences     fasting-induced migraine or hunger-induced migraine. With a given migraine incidence of 28     million in the United States alone, we estimate that approximately 7 million will experience     hunger as a migraine trigger. If an individual has a known migraine trigger, then there are a     variety of ways to modify care in order to address that trigger. The simplest is to avoid     that trigger or preemptively treat that trigger. Frovatriptan has good evidence for daily use     for a short time to help prevent menstrually related migraines. A short course of treatment     can often avoid the initiation of the migraine and improve quality of life. Knowing that a     longer acting triptan, such as frovatriptan, has demonstrated capability at suppressing     headache through a known trigger, suggests the need to study this with fasting induced     migraines, as well.   "
198096|NCT00440245|"     This study will investigate potential differences in how two puffs of salbutamol protects     airway smooth muscle from contracting in people with asthma and chronic obstructive pulmonary     disease (COPD).   "
198097|NCT00440258|"     The present study was designed to provide clinical confirmation of Cb2’s value as a new     approach in the prevention of increased vascular permeability and hemoconcentration, both     signs of OHSS in humans, and in order to explore its mechanism of action. To this end, a     prospective, randomized, placebo-controlled study was designed in which Cb2 was employed in     women at risk of OHSS after gonadotropin administration for ART. Simultaneously, ovarian     perfusion was assessed in these patients using MR pharmacokinetic modeling.   "
198098|NCT00440271|"     The primary purpose of this study is to:        1. Demonstrate the safety and efficacy of tipranavir/ritonavir (TPV/r) among a racially          diverse HIV+ population (males and females) who are three-class (nucleoside reverse          transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI),          and protease inhibitor (PI)) experienced with documented resistance to more than one PI.        2. Determine pharmacokinetic data in this racially and gender diverse population.        3. Determine the potential utility of using therapeutic drug monitoring (TDM) in improving          efficacy outcomes.   "
198099|NCT00440284|"     Objective. Flexible, intensive insulin therapy (FIT) with pre-prandial regular insulin and     conventional insulin therapy (CIT) with twice daily premixed insulin are treatment options in     patients with type 2 diabetes who become insulin dependent. While intensive insulin therapy     can increase meal and life style flexibility, conventional therapy is easier to perform. The     aim of the study was to compare metabolic outcomes and patient preferences of both treatment     regimens.      Research Design and Methods. Non-blinded, randomized controlled cross-over clinical pilot     trial. Insulin naive participants who failed therapeutic goals under oral antidiabetic     therapy underwent FIT and CIT for two months. Patients completed standard Diabetes Treatment     and Teaching Programs (DTTP) and trained FIT and CIT. Main outcome measures were glycosylated     hemoglobin (GHb), mild and severe hypoglycemia, insulin dosage, blood pressure and     body-mass-index (BMI). Before/after and inter-group analyses were performed. Finally, therapy     preference was analyzed.   "
198100|NCT00440297|"     To describe the immunogenicity and safety of modified process hepatitis B vaccine     administered to renal predialysis and dialysis patients   "
198101|NCT00440310|"     The purpose of the study is to assess the overall survival and progression free survival of     patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of     Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™     therapy.      Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology,     Bellevue, Washington), and a light generating device, composed of light-emitting diodes     (LEDs), that is energized by a power controller and percutaneously placed in the target tumor     tissue inside the body.   "
198102|NCT00440323|"     Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG     nights, study drug administration and noise model is conducted on second night.   "
198103|NCT00440336|"     WHAT IS THIS STUDY ABOUT? Glaucoma and ocular hypertension are chronic eye diseases that can     damage the optic nerve and lead to vision loss or blindness. The optic nerve acts like an     electric cable with over a million wires. This nerve is responsible for carrying images from     the eye to the brain. The way glaucoma and ocular hypertension cause blindness depends on     many factors, but the most important factor is the increased pressure inside the eye     (intraocular pressure).      There is no cure for glaucoma or ocular hypertension. However, lowering the pressure inside     the eye has been shown to slow the progression of disease. Intraocular pressure can be     lowered by glaucoma medication, laser treatment, or surgery.      You have open angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension. Researchers     want to find out more about how 2 drugs called Cosopt (dorzolamide hydrochloride and timolol     maleate) and Xalatan (latanoprost) can help people with these conditions.      Cosopt and Xalatan are both eye drops that are approved by the U.S. Food and Drug     Administration (FDA) to reduce intraocular pressure in people with open angle glaucoma and     ocular hypertension.      The study doctor will do a laser procedure called Selective Laser Trabeculoplasty (SLT) on     people in this study to help lower their intraocular pressure. The FDA has approved SLT to     treat open angle glaucoma and ocular hypertension.      Then the study doctor will ask some participants to use either Cosopt or Xalatan, if their     intraocular pressure is still too high 4 to 6 weeks after the SLT procedure. The study doctor     wants to see which of the 2 study drugs (Cosopt or Xalatan) is better at reducing intraocular     pressure after SLT.      It is planned that about 30 people with glaucoma or ocular hypertension who are at least 18     years old will be in this study. Out of the participants whose intraocular pressure is still     too high after SLT, half will use Cosopt and half will use Xalatan. You do not have to be in     this study to have SLT or to use Cosopt or Xalatan.   "
198124|NCT00440609|"     The purpose of this study is to evaluate the safety and tolerability of Ranibizumab in     patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare     treatment outcomes for patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and     2.0mg Ranibizumab.   "
198104|NCT00440349|"     Idiopathic retroperitoneal fibrosis (IRF) is a rare disease characterised by the presence of     a retroperitoneal periaortic fibro-inflammatory tissue which may entrap the ureters and cause     renal failure. The treatment of IRF is not well established. Corticosteroids are frequently     used, but the anti-estrogen agent tamoxifen has also been reported to be effective in a     number of reports. However, no randomised trials have been published so far. The aim of the     present study is to compare the efficacy of prednisone and tamoxifen in the treatment of IRF.   "
198105|NCT00440362|"     AVX502, an alphavirus replicon vaccine expressing an influenza HA protein, is a candidate     vaccine against influenza.      The objectives of this Phase 1 study are to test the safety of the vaccine and the immune     response to the vaccine in healthy volunteers 18-40 years of age. Volunteers will be assigned     by randomization to receive either the vaccine or an inactive substance (placebo) by     injections in each arm on one or two occasions over 2 months. The study will last 4 months     and will have a total of 8 visits.   "
198106|NCT00440375|"     The purpose of this study is to evaluate the effect of rosiglitazone on bone metabolism and     to assess the association between the changes in bone turnover parameters and plasma cytokine     levels in postmenopausal diabetic women   "
198109|NCT00440414|"     The second-line treatment in advanced NSCLC has been currently proved effective in prolonging     overall survival and improving quality of life. Both pemetrexed and erlotinib have been     approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the     treatment of advanced NSCLC, especially for elderly patients, due to convenience of     administration and safety profile. The role of comprehensive geriatric assessment in     treatment efficacy and tolerance is an area of investigation.   "
198110|NCT00440427|"     To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to     healthy subjects.   "
198111|NCT00440440|"     The purpose of the study is to find out the effect of replacing testosterone in the form of a     gel (Androgel®) on the amount of fat mass in males with low testosterone and diabetes.   "
198112|NCT00440453|"     The aim of the present study is to take stronger action in solving the problems of     malnutrition in the hospital setting and in the first two months after patient's discharge.     The main objective is to evaluate the clinical benefit (eg. QoL, body composition and body     function) of nutritional intervention (nutritional therapy) in a sample of patients at     nutritional risk according to the NRS 2002.   "
198113|NCT00440466|"     The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks     treatment with epoetin alfa, a drug that increases red blood cell production, in patients     with anemia associated with chronic kidney disease, is not less effective than treatment with     epoetin alfa that is given once a week   "
198114|NCT00440479|"     The primary aim of this observational study is to collect safety and effectiveness data for     bortezomib used at first relapse in a group of multiple myeloma patients who received     specific and well defined first line treatments within previous clinical studies.   "
198115|NCT00440492|"     The purpose of this study is to determine if PLA-695 changes the blood concentrations of     methotrexate when administered together.   "
198116|NCT00440505|"     The purpose of this study is to test whether transdermal nicotine reduces pain among women     with chronic pelvic pain.   "
198117|NCT00440518|"     The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by     mouth, twice a day for up to 18 weeks to prevent migraines.   "
198118|NCT00440531|"     The purpose of this trial is to determine if there is an improvement in the immune response     of older adults over 50 years of age using a modified process hepatitis B vaccine and a     currently licensed hepatitis B vaccine (RECOMBIVAX HB™).   "
198119|NCT00440544|"     The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two     nasal immunizations composed of a hybrid protein antigen from M. tuberculosis virus mixed     with a toxoid adjuvant, causes untoward adverse reactions when administered to healthy adult     volunteers. Both subjects who have not received Bacillus Calmette-Guerin (BCG) and subjects     who have already received BCG will be enrolled. An initial evaluation of immune responses to     the vaccine will also be undertaken.   "
198120|NCT00440557|"     The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment     with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not     less effective than the approved treatment with epoetin alfa that is given 3 times weekly     with respect to changes in hemoglobin.   "
198121|NCT00440570|"     In vitro studies suggest that low levels of amplitude-modulated electromagnetic fields may     modify cell growth. We have identified specific frequencies that may block cancer cell     growth. We have developed a device delivering low levels of amplitude-modulated     electromagnetic fields. The device is connected to a spoon-like coupler, which is placed in     the patient's mouth during treatment. We will conduct a feasibility study consisting of three     daily ambulatory treatments until disease progression.   "
198122|NCT00440583|"     The purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients     with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial     remission after 6 cycles of CHOP therapy.   "
198123|NCT00440596|"     Nearly 60 million adults in the United States have high blood pressure (BP) in the     pre-hypertension (SBP 120-139 or DBP 80-89). Hypertension is estimated to account for 1 in 8     deaths in the world, and in the US the direct and indirect costs of high BP are estimated to     reach $59.7 billion in 2005. JNC-7 guidelines recommend lifestyle modifications for     prehypertension, followed by antihypertensive medication if BP progresses to Stage I     hypertension. Mindfulness-based Stress Reduction (MBSR) is an increasingly popular practice     that has been purported to alleviate stress and treat certain health conditions. Some stress     management therapies and one meditation therapy (e.g., Transcendental Meditation) have shown     promise in reducing elevated BP, but MBSR has not been evaluated as a treatment for high BP.     When added to lifestyle modification advice, MBSR may be an appropriate complementary     treatment for prehypertension. However, prior to a large randomized clinical trial of MBSR     for prehypertension and/or hypertension, pilot data is necessary to provide preliminary     evidence of a treatment effect and to evaluate feasibility. This feasibility randomized     clinical trial of MBSR for unmedicated prehypertension will provide preliminary evidence to     support a larger randomized clinical trial by evaluating the feasibility and safety of MBSR     as a complementary treatment for high BP and by documenting any treatment effect. Sixty     patients with unmedicated BP in the range of SBP 120-139 mm Hg or DBP 80-89 mm Hg will be     randomly assigned to MBSR or a progressive muscle relaxation control condition. All patients     will receive lifestyle modification advice. Patients will complete 8 weeks of MBSR delivered     in a group format by an experienced psychologist trained in MBSR or 8 weeks of progressive     muscle relaxation training matched for therapist contact and homework. Patients BP will be     assessed prior to randomization and following treatment by researchers blind to treatment     assignment. Accrual rates, acceptance of randomization, treatment adherence, treatment     fidelity, and patient satisfaction with treatment will be evaluated.   "
198125|NCT00440622|"     The optimal treatment for pretreated patients with metastatic breast cancer has not been     established. Gemcitabine and capecitabine are two active agents in this setting. For women     with Her-2 positive breast cancer, combinations of either gemcitabine or capecitabine     (Xeloda) plus Herceptin has been proved active and well tolerated.   "
198126|NCT00440635|"     The purpose of this study is to provide bortezomib to patients with multiple myeloma who have     received at least 2 previous lines of therapy and are refractory or have relapse after their     last treatment. Additional objectives of this study are assess the safety and tolerability of     bortezomib and follow the levels of paraprotein in patients receiving bortezomib as a way to     followup disease burden   "
198141|NCT00440830|"     Effect of nicotine patch as an adjutant for acute pain after surgery.   "
198423|NCT00446511|"     The purpose of this extension study is to compare the long-term safety of valsartan versus     enalapril, and the effectiveness of the combination of valsartan and enalapril versus     enalapril alone in children with hypertension.   "
198127|NCT00440648|"     This is a double-blind, randomized, cross-over study conducted at centers within the United     States. The study consists of five periods: an up to two-week Screening Period, a 5-week     Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients     are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight     weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for     eight weeks followed by sevelamer carbonate for eight weeks   "
198128|NCT00440661|"     Some inflammation mediators, notably IL-1, are implied in the joint degeneration phenomena of     osteoarthritis. The aim of this study is to confirm in vivo the favourable effect of     diacerhein on IL-1 and also to appreciate its effect on other synovial inflammation     mediators.   "
198129|NCT00440674|"     The primary objective of this study is to evaluate the safety and effectiveness of a direct     stenting technique compared to conventional stenting with pre-dilatation strategy using the     CoStar Paclitaxel-eluting coronary stent system for the treatment of a single de novo lesion     in a native coronary artery ≤ 25 mm long in a native coronary artery 2.5-3.5 mm diameter.   "
198130|NCT00440687|"     Guidelines recommend inhaled corticosteroids (ICS) for patients with moderate to severe     chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care     and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from     COPD patients in primary care is unknown.This randomised double-blind placebo-controlled     trial will evaluate the effect of withdrawal of inhaled corticosteroids in patients with COPD     recruited from general practice. Participants will have a clinical and spirometric diagnosis     of COPD and will have been prescribed inhaled steroids for the 6 months before entry to the     trial. They will be randomised to taking a fixed dose steroid inhaler (Flixotide Accuhaler)     or an identical placebo inhaler. Patients will be monitored using diary cards for a year with     3 monthly follow-up visits at their general practice. The primary outcome measures will be     exacerbation frequency and severity. Other outcomes are time to first exacerbation, costs,     health status, lung function and unscheduled care. We tested the hypothesis that withdrawal     of ICS in this population would lead to an increased number of exacerbations, earlier onset     of exacerbation, and a worsening of symptoms.   "
198131|NCT00440700|"     The purpose of this study is to test whether patients who are receiving mechanical     ventilation in the ICU who listened to preferred, relaxing music whenever they desire for as     long as they desire will have less anxiety, receive fewer medications, stay in the ICU for a     shorter time, and experience less stress than patients who do not listen to music.   "
198132|NCT00440713|"     32 outpatients with a Posttraumatic Stress Disorder were included in a randomized comparative     single-blind study to study the efficacy of aripiprazole to treat post-traumatic stress     symptoms.      The hypothesis is that aripiprazole has an efficacy to reduce PTSD symptoms   "
198133|NCT00440726|"     This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy     drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred).     Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for     treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been     shown to cause cancer cells to die in studies done on animals (mice). Studies have been done     that have shown that some adults and children with cancer have shown a response to bortezomib     when it is used alone. Studies have also been done in adults to evaluate the dose of     bortezomib that can be safely given in combination with other chemotherapy drugs.      The Phase I portion of this study is complete and the dose for the phase II portion of the     study is 1.3mg/m2/day. The phase II portion of the study is open and accruing.   "
198134|NCT00440739|"     The purpose of this study is to determine whether etoricoxib, flavoxate, both are effective     in the treatment postoperative pain after TURP.      The research hypothesis:      There is a difference in postoperative morphine consumption in the first 24 hours after     transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and     placebo.   "
198135|NCT00440752|"     The newly introduced antimalarial drug artemether-lumefantrine is currently recommended as     second line antimalarial in Sudan. Recurrent infection after treatment with this drug has     been associated with selection of certain genes in the malaria parasite. However there is no     information on this association in Sudan.This study is going to look into the genetics of     resistance to artemether-lumefantrine.   "
198136|NCT00440765|"     The main purpose of this study is to evaluate safety and effectiveness of the treatment of     multiple myeloma with bortezomib in daily practice in the Netherlands.   "
198170|NCT00441207|"     The primary purpose of this study is to evaluate the safety and tolerability of vitamin C     (ascorbic acid) given by injection into the vein.      The second and third purpose of conducting this study is to observe any evidence of tumor     response to the vitamin C and compare the level of fatigue (weakness), pain control, ability     to do things, and quality of life, before and after vitamin C is given.   "
198185|NCT00434356|"     This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide     a preliminary assessment of the safety and efficacy of sunitinib when combined with     bevacizumab and paclitaxel in patients who have not previously received chemotherapy for     locally recurrent or metastatic breast cancer.   "
198137|NCT00440778|"     HYPOTHESES        1. Bolus administration of total abciximab dose provides superior maximal and mean platelet          aggregation inhibition (PAI) compared with standard bolus (0.25 mg/kg) administration.        2. Total dose of abciximab can be given as a single bolus and is more effective than bolus          (0.25 mg/kg) + 12 hrs infusion in terms of acute and mid-term angiographic and clinical          results.        3. Intracoronary (ic) abciximab administration is more effective than intravenous (iv)          route of administration in terms of acute and mid-term angiographic and clinical          results.        4. There is a relationship between PAI and angiographic perfusion scores.        5. Routine use of sirolimus-eluting stents (Cypher, Cordis) in primary-PCI is associated          with a low rate of target vessel revascularization and complications.        6. Cardiac MRI early and late after primary-PCI provides detailed information on myocardial          injury and irreversible necrosis, which are correlated with angiographic perfusion          scores.        7. After uncomplicated trans-radial PCI, patients can be retransferred early to their          referring center.   "
198138|NCT00440791|"     This multi-center, prospective, cohort study of 394 subjects that are indicated for standard     colonoscopy due to suspected or known colonic disease examines the Given Diagnostic System     and the PillCam Colon Capsule in comparison to standard colonoscopy. This study aims a. To     evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard     colonoscopy. This study will evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE)   "
198139|NCT00440804|"     The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine     iv in premature infants in the early treatment of Patent Ductus Arteriosus.   "
198140|NCT00440817|"     The purpose of this study is to examine the association with EBV infection, monitor the     occurrence of lymphoma and assess lymphoma risk in patients with rheumatoid arthritis and/or     Crohns disease and you have taken infliximab.   "
198142|NCT00440843|"     Individuals with schizophrenia frequently have impairments in attention. These impairments     have been shown to be related to overall functioning. Some research suggests that Olanzapine     may be associated with improvement in various aspects of attention. The primary purpose of     this study is to determine whether switching from a typical antipsychotic to Olanzapine     improves task engagement. Individuals who taking typical antipsychotics will be randomly     assigned to either 1) remain on their typical antipsychotic medications, or 2) be switched     from their typical antipsychotic medications to Olanzapine. All participants will be enrolled     in a twice-weekly 20 session cognitive training program that is specifically designed to     target attention deficits and promote active engagement. Improvements in attention will be     compared between individuals who remained on their typical antipsychotic medications and     those that were switched to Olanzapine.   "
198143|NCT00440856|"     The trial aims to assess the hypothesis that presentation of the disc material to the patient     following a lumbar microdiscectomy would positively influence the improvement in their leg     and back symptoms.   "
198144|NCT00440869|"     The purposes of the study are to determine whether oxidative stress causes the muscle of     dialysis patients to tire more quickly than muscle of people without kidney disease and to     determine whether treatment with N-acetylcysteine, an antioxidant, can improve muscle     endurance.   "
198145|NCT00440882|"     Transforming Growth Factor-b1 (TGF-b1) is involved in the development of acute lung injury     and in the fibroproliferation during acute respiratory distress syndrome (ARDS). Procollagen     III Peptide (PIIINP) is a validated marker of fibroproliferation. PIIINP is associated with     death in ARDS patients. The simultaneous changes of TGF-b1 and PIIINP were never studied in     patients with ARDS. The relationships between TGF-b1 and the outcome of ARDS are unknown.      The aim of the study is to analyse the changes of TGF-b1 and PIIINP during ARDS and to show     the relationships between TGF-b1 - PIIINP and the outcomes of ARDS.   "
198146|NCT00440895|"     -  Abciximab administration is safe and reduces ischemic complications in patients          undergoing rescue PCI after failed thrombolysis compared to placebo.        -  Abciximab improves angiographic scores and ventricular function after rescue-PCI          compared to placebo.        -  Intracoronary abciximab administration is more effective than intravenous route of          administration in terms of acute and mid-term angiographic and clinical results.        -  Intracoronary and intravenous bolus administration of abciximab dose provides similar          platelet aggregation inhibition (PAI).        -  There is a significant relationship between PAI after abciximab administration and          indexes of myocardial perfusion.        -  Routine use of Sirolimus-eluting stents (Cypher, Cordis, US) in rescue-PCI is associated          with a low rate of target vessel revascularization.        -  Cardiac MRI early and late after rescue-PCI provides detailed information on myocardial          injury and irreversible necrosis, which are correlated with angiographic perfusion          scores.        -  After uncomplicated trans-radial rescue PCI, patients can be retransferred early to          their referring center.   "
198147|NCT00440908|"     The study is a prospective cohort trial utilizing sequential laboratory results from excess     serum obtained from hemodialysis patients (acting as their own controls). The objective of     this study is to determine the impact of converting from reuse to single use of dialyzers on     specific markers of nutrition (pre-albumin) and inflammation (CRP) in hemodialysis patients     followed over a period of 6-months after conversion. The Hypothesis is: Comparing values     obtained at baseline to values at the end of 6-months after conversion from reuse to single     use in the same patients:        1. In patients with baseline CRP > 5 mg/L: Mean decrease of 5 mg/L        2. In patients with baseline CRP < 5 mg/L: > 95% will remain < 5 mg/L        3. Mean serum pre-albumin levels will increase by at least 3 mg/dL. The study population          will be drawn from ~2,900 patients that are currently undergoing hemodialysis in 48          dialysis units that have been identified as continuing to reuse dialyzers and          specifically are using a peracetic acid-based disinfectant (Renalin®), as of February 1,          2007. These facilities will be scheduled to convert to single use of dialyzers between          May and December, 2007. The selection of patients will depend solely on the facility          conversion date, on a first-come, first-served basis. All patients within the dialysis          facility that provide blood specimen for their routine monthly lab draws will be          eligible. The facilities and patients will be enrolled consecutively until the desired          sample size of approximately 2,500 patients is reached   "
201176|NCT00484146|"     Severe sepsis induces significant changes in expression of insulin- and toll-like receptors,     cytokines, markers of apoptosis, and activation of t- and b-lymphocytes.   "
198148|NCT00440921|"     -  Thermogenesis is a company that sells a machine for the production of fibrin sealant of          single donor plasma, the CryoSeal Fibrin Sealant System (CS-1).        -  Fibrin sealant consists of two components: cryoprecipitate and thrombin. Cryoprecipitate          is the fraction of human plasma that contains concentrated coagulation factors, such as          fibrinogen. Thrombin is an enzyme that facilitates the conversion of fibrinogen into          fibrin, so that a clot will be formed.        -  Fibrin sealant can be used in surgery to increase hemostasis in the wound after e.g.          knee- or hip replacement, cosmetical surgery or partial liverresections.        -  Until now, mainly autologous plasma was used to produce fibrin sealant with the CS-1.          Within Sanquin there is a question whether fibrin sealant can be produced from the          allogeneic quarantaine plasma that is in stock. Therefore in this study will be studied          whether allogenous single donor fibrin sealant produced using the CS-1 is effective in          wound healing and as consequence of this can be registered as a product of Sanquin. To          answer these questions a national working party is formed, working party Fibrin Sealant.        -  So far, three man personnel in Sanquin Blood Bank Nort East Region (SBNO) are certified          by Thermogenesis to use the CS-1 for production of fibrin sealant and an in vitro          validation has been performed.        -  The next step will be a study for the in vivo effectiveness of fibrin sealant produced          of single donor allogeneic quarantaine plasma using the CS-1. As control patients          without fibrin sealant treatment will be studied. Two hospitals (Refaja Hospital in          Stadskanaal and Wilhelmina hospital in Assen) are already interested in participating in          this study. Probably, three more hospitals will participate.        -  The use of fibrin sealant will be studied in a prospective randomized trial for patients          undergoing knee and hip replacements.   "
198149|NCT00440934|"     Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one     million two hundred thousand new patients are diagnosed each year. The prognosis of patients     suffering from advanced hepatocarcinoma is poor with an average survival of less than six     months. Phase I data suggest that low levels of electromagnetic fields administered     intrabucally with a portable and programmable device are a safe and potentially effective     treatment for advanced cancer. The device is connected to a spoon-like coupler placed in the     patient's mouth during treatment. Patients with advanced HCC and limited therapeutic options     will be offered treatment with a combination of frequencies.   "
198189|NCT00434408|"     A community based trial that seeks to address the effect of umbilical cord cleansing using     4.0% chlorhexidine cleansing solution   "
198424|NCT00446524|"     The purpose of this study is to evaluate long-term safety and tolerability of once daily     administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in     patients with essential hypertension.   "
198150|NCT00440947|"     This study was designed to test the efficacy, safety, tolerability and durability of the     antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC)     Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by     randomization to either a simplification regimen of ATV or continuation of ATV +/r for an     additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1     infected, HLA-B*5701 negative subjects.      All subjects who complete the 84-week study will be eligible to enter the treatment extension     phase and continue for an additional 60 weeks. The purpose of this extension is to obtain     longer term treatment data in subjects who have completed the 84-week study.   "
198151|NCT00440960|"     The objective of the study was to establish which anesthetic procedure used during flexible     bronchoscopy has the lowest index of complications.   "
198152|NCT00440973|"     The purpose of this study is to determine if the combination of therapy to strengthen the     immune system (Interleukin - 2) plus a specific tumor target therapy (Bevacizumab) can     prolong the time between the start of treatment and disease progression, decrease tumor size,     as well as determine if the combination therapy is safer and less toxic than the standard     treatment for renal cell carcinoma.   "
198153|NCT00440986|"     The purpose of study is to determine the best and durable choice of treatment between     phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH   "
198154|NCT00440999|"     The purpose of this study is to compare the efficacy and safety of the fixed combination of     pyronaridine artesunate (180:60 mg) with that of standard chloroquine therapy in children and     adults with acute, uncomplicated Plasmodium vivax malaria.   "
198155|NCT00441012|"     To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus)     in healthy infants using a modified process in a combination Haemophilus Influenzae, type     b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B     vaccine   "
198156|NCT00441025|"     The purpose of this study is to determine whether the treatment of Alemtuzumab in combination     with CHOP(cyclophosphamide,doxorubicin,vincristine and prednisolone) are effective as first     line treatment in patients with peripheral T-cell lymphoma.   "
198157|NCT00441038|"     The primary purpose of this study is to compare, in retired persons living in the Balearic     Islands, the effectiveness on low back pain related disability of three educational programs.     All consist of a group talk and the handout of a booklet, each one different in its content.   "
198158|NCT00441051|"     Diclofenac sodium 0.1% will be applied to sunburned skin when the intensity of pain reaches a     certain level in order to evaluate the efficacy and safety of the treatment on this induced     pain.   "
198159|NCT00441064|"     This study will compare the effects of high and low level sodium (salt) diets on blood     pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.   "
198171|NCT00441220|"     Cyclophosphamide is widely used in the treatment of cancer and autoimmune diseases such as     lupus nephritis. However, there is considerable variability in the response to     cyclophosphamide treatment. Cyclophosphamide is a pro-drug that requires initial activation     by CYP liver enzymes. Recent clinical studies have indicated a possible role of one CYP     enzyme, CYP2C19 in this activation step. This enzyme has a genetic polymorphism (variants     which lack functional activity) and people who have inherited these variants are poor     metabolisers of certain drugs.      The aim of this study is to determine whether response to therapy in a New Zealand population     of lupus nephritis patients is determined by cyclophosphamide bioactivation (the metabolic     phenotype) and CYP genotype.      Currently there is no way of predicting a patient's response to cyclophosphamide. An     understanding of the factors which contribute to the therapeutic failure in lupus nephritis     is particularly important due to the high morbidity and mortality associated with this     disease. There are other treatment options for lupus nephritis patients who fail to respond     to cyclophosphamide. If successful, this study may help identify patients who are unlikely to     respond to cyclophosphamide and thus should not be unnecessarily be exposed to the drug and     may justify the use of newer, more costly immunosuppressive drugs such as mycophenolate     mofetil and rituximab.   "
198172|NCT00441233|"     The primary purpose of this study is to investigate the clinical performance of a new     silicone hydrogel contact lens over a period of 6 months of extended wear.   "
198160|NCT00441077|"     This study will examine how to communicate with an underserved population about inherited     disease risks. It will present information about inherited risk to a Latino population     through either a lay health advisor (LHA) or through printed information. The LHA is a member     of the Latino community who has received training in public speaking, group facilitation, and     managing group dynamics and in family health history and genetics. Previous studies have     shown that an LHA can effectively communicate health information to diverse audiences, but     such interventions have not been studied in the context of inherited risk.      Spanish-speaking Latino men and women over the age of 18 in the Oakland, CA, and Washington,     DC, areas who have basic Spanish reading and writing skills may be eligible for this study.      Participants are recruited to one of two groups. One group participates in group educational     sessions with an LHA about inherited disease risks and family health history, and the other     receives this information from a brochure.      Educational Sessions      Groups of 5 to 8 individuals complete a questionnaire and then participate in a 45-minute     educational session on concepts related to genetics, family health history, lifestyle and     environment. Participants engage in role-playing to practice discussing family health history     with family members. The LHA teaches participants the skills needed to fill in family health     history tool called My Family Health Portrait and answers questions. After the question and     answer session, participants complete a second questionnaire.      Brochure-Only      Participants complete a questionnaire and then read a Spanish-language brochure produced by     the U.S. Surgeon General's Office about the importance of knowing one's family history. They     then complete a second questionnaire.   "
198161|NCT00441090|"     The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501     tablets, as compared to placebo, in the treatment of patients with chronic Idiopathic     Thrombocytopenic Purpura (ITP).   "
198162|NCT00441103|"     General Note: throughout this record, Rebif® New Formulation is used for historical and     consistency purposes.      Objectives:      Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a     [IFN-beta-1a], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple     Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16     weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of     combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo     treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to     placebo.      Primary Endpoints: The primary endpoint is the difference between the number of CU active MRI     lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2).      Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active     MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16     versus Weeks 17 - 40 for the subjects randomized to Group 2.   "
198163|NCT00441116|"     The aim of this Phase III study is to compare the efficacy, safety and tolerability of     dutasteride (0.5mg) with placebo for 6 months, in Korean male subjects with androgenetic     alopecia in the vertex region, types IIIv, IV and V according to the modified     Norwood-Hamilton Classification.   "
198190|NCT00434421|"     Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance     and adverse events with subcutaneous allergen immunotherapy have generated interest in     delivering immunotherapy sublingually (under the tongue). The purpose of this study is to     evaluate the safety of a cockroach extract given sublingually to people with perennial     (year-round) allergic rhinitis, with or without asthma.   "
198164|NCT00441129|"     . PRIMARY ENDPOINT      The primary endpoint will be the change from baseline (Visit 3) to 6 months (Visit 6) of     centrally measured HbA1c      SECONDARY ENDPOINTS        1. Change from baseline in mean blood glucose value calculated from CGMS recordings.        2. Change from baseline in occurrence of hyperglycemia above 190 mg/dl .        3. Change from baseline in occurrence of hypoglycemia below 70 mg/dl 4. Change from          baseline of insulin doses.      5. Total daily use of insulin. 6. % of daily use of insulin as basal rate. 7. % of daily use     of insulin as bolus. 8. Patient Satisfaction questionnaire. 9. Health economic questionnaire.     10. Quality of life questionnaire   "
198165|NCT00441142|"     Phase I:      The purpose of this research study is to determine the safety of the combination treatment of     ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas,     temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment     of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that can be given     safely when combined with temozolomide (Temodar) and radiation therapy.      Phase II:      The purpose of this research study is to determine the efficacy of the combination treatment     of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas,     temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment     of glioblastomas.      All subjects participating in this research study must NOT be taking a certain type of     anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include (but     are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and     trileptal.   "
198166|NCT00441155|"     To provide study drug to patients that benefit from treatment judged by the investigator - to     obtain additional long-term safety and efficacy data of this combination regimen in GIST   "
198167|NCT00441168|"     The purpose of this research study is to test the safety and effectiveness of replacing     vincristine with a drug called bortezomib (also known as Velcadeor PS341) in the standard     therapy vincristine, doxorubicin (not limited to, but formerly referred to under the     tradename Adriamycin) and dexamethasone (VAD) in patients with multiple myeloma. Multiple     Myeloma is the second most common cancer of the blood. Bortezomib is the first approved     cancer treatment in a new class of medicines called proteasome inhibitors. It disrupts the     cell cycle of the cell, affecting numerous biologic pathways, including those related to     growth and survival of cancer cells. The treatment will be used as second line treatment,     which means either the disease has returned after a period of improvement (relapse) or the     disease did not respond to the initial treatment (refractory). Patients will receive either     bortezomib (PS341), doxorubicin (Adriamycin) and dexamethasone (PAD) or the VAD standard     therapy.   "
198168|NCT00441181|"     Prostaglandin analogues have not been used in the treatment of neovascular glaucoma because     of suspicious lack of efficacy. This study aims at assessing the effect of travoprost on     neovascular glaucoma.   "
198169|NCT00441194|"     To compare the Octopus 311 and the HFA 700 series   "
198174|NCT00441259|"     This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in     India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV)     or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a     treatment period and a 2 year follow-up period.      Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of     vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days     after completing vaccination.   "
198191|NCT00434434|"     This was a multicenter, randomized, double-blind, parallel-group, three-arm,     placebo-controlled study designed to demonstrate the efficacy of two different formulations     of omalizumab compared with placebo in reducing the airway reaction to an inhaled     aeroallergen solution in adult subjects with mild allergic asthma.   "
198192|NCT00434447|"     This study is designed to monitor the safety and efficacy of long-term treatment with     zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the     jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment   "
198193|NCT00434460|"     The purpose of this prospective, multicentre, time-series study is to develop, implement,     refine, and evaluate a sustainable behaviour change strategy in the intensive care unit     (ICU).   "
198175|NCT00441272|"     This study will determine whether pioglitazone (Actos, a drug approved to treat diabetes, can     benefit HIV-infected people with fatty liver. Fatty changes of the liver (also known as     steatosis) have been linked to diabetes and long-term liver damage in some patients.     Pioglitazone has been shown to improve fatty liver in people without HIV; this study will see     if it is beneficial for people with HIV as well.      HIV-infected patients 18 years of age and older with increased fat in the liver may be     eligible for this study. Screening includes a CT scan and liver biopsy (withdrawal of a small     sample of liver tissue through a needle).      Participants are randomly assigned to take either 45 mg of pioglitazone or placebo (sugar     pill) by mouth once a day for 48 weeks. At the end of 48 weeks, all participants stop taking     their medication and are followed for an additional 48 weeks to see what, if any benefits, of     pioglitazone persist after treatment is stopped. In addition to taking the study medication,     participants undergo the following procedures:        -  Visits to the NIH Clinical Center over a period of approximately 2 years at day 0 and          weeks 2, 8, 16, 24, 32, 40, 48, 52, 72, and 96. Most visits take about 1 hour and          include blood drawing for various laboratory tests.        -  Insulin clamp test at day 0 and weeks 24 and 48 to see how the body processes glucose.          This test takes 4 to 6 hours and may include an overnight stay at the Clinical Center. A          catheter (plastic tube) is placed in a vein in the arm to infuse insulin and another is          placed in a vein on the back of the hand to draw blood samples. Blood sugar is checked          frequently and glucose is given to keep blood sugar at normal values.        -  Nutrition evaluations at day 0 and weeks 24 and 48. Subjects write down all the food          they eat and drink for 4 days before the visit. They meet with a nutritionist to review          the food record and to complete simple measurements of body fat and shape.        -  CT scan of liver and abdomen at weeks 24, 48, 72 and 96.        -  Liver biopsy at week 48.   "
198176|NCT00441285|"     The purpose of this study is to determine if combination drug therapy of praziquantel and     albendazole is safe and effective to cure neurocysticercosis.   "
198177|NCT00441298|"     This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1%     Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900     young women at risk of sexually transmitted HIV infection. Participants will be provided with     a supply of single-use, pre-filled applicators according to their randomisation. While in the     study, participants will be asked to apply a first dose of the assigned study gel within 12     hours prior to coitus and insert a second dose as soon as possible within 12 hours after     coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic     treatment of sexually transmitted infections, if required.   "
198178|NCT00441311|"     The aim is to assess the efficacy of an intervention, academic detailing, a brief, frequently     repeated educational program, on increasing recommendations for colorectal cancer screening     among primary care providers by comparison to a service-as-usual control. The study is a     stratified randomized clinical trial of primary care physicians, stratified by distinct urban     communities in the New York metropolitan area. The primary outcome is colorectal cancer     screening recommendations measured via medical audit at 12-month followup after     randomization.   "
198179|NCT00441324|"     In programmes of IVF, normal women undergo controlled ovarian stimulation using exogenous FSH     injections to obtain multiple eggs. The process results in eggs of mixed quality with a broad     range of developmental and implantation potential.      The aim of the study was to determine whether, treatment with recombinant human LH prior to     the FSH injections can improve outcome for women undergoing IVF. High grade embryos implant     with a higher frequency and baby delivery rate than poor quality embryos. The mature oocyte     is the most important determinant of embryo quality. Early follicles, containing immature     eggs, have LH receptors in the theca cells that surround the follicle, and LH stimulates     these cells to produce factors essential for normal follicular development.      The intent of the study was to use recLH treatment prior to recFSH to treat a cohort of     follicles, so that they can all mature together, thus increasing the proportion of high grade     oocytes and their subsequent embryos   "
198180|NCT00441337|"     To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when     administered to patients with advanced non-small cell lung cancer, colorectal cancer,     malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer   "
198181|NCT00441350|"     The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ     40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic     BP in hypertensive patients after 8 weeks of double-blind treatment.      The study consisted of two sequential phases of 8 weeks duration each:      During the first phase, OM 40 mg monotherapy was compared with OM/HCTZ 40/12.5 mg in order to     evaluate the additional benefit of OM/HCTZ 40/12.5 mg in the treatment of essential moderate     to severe hypertension.      During the second phase, patients whose BP proved to be insufficiently controlled by the OM     40 mg monotherapy were to start OM/HCTZ 40/12.5 mg combination therapy while patients whose     BP proved to be insufficiently controlled by the OM/HCTZ 40/12.5 mg combination were to be     up-titrated to the OM/HCTZ 40/25 mg combination to evaluate the additional benefit of the     up-titrated combination.      The study was be conducted by qualified and experienced personnel with adherence to GCP,     current guidelines on the design of studies in hypertension, the applicable regulatory     requirements and the ethical principles based on the Declaration of Helsinki.   "
198182|NCT00441363|"     The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo     when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in     persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy     alone.   "
198186|NCT00434369|"     A multi-center, open-label, single-arm Phase II trial assessing the efficacy and safety of     weekly bolus infusions of 5-fluorouracil combined with CoFactor (5-10     methylenetetrahydrofolate) in advanced breast cancer patients who failed anthracycline and     taxane chemotherapy regimens.   "
198187|NCT00434382|"     The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory     suppression should be evaluated during a wide spectrum of clinically common forms general     anesthesia.   "
198188|NCT00434395|"     The purpose of the study is to assess the effects of MOA-728 on cardiac repolarization in     healthy subjects.   "
198194|NCT00434473|"     The study will be conducted at 15-20 US centers in a randomized, placebo-controlled,     double-blind fashion. Enrollees will be hospitalized sickle cell disease (SCD) patients     at-risk for acute chest syndrome (ACS) based on the presence of vaso-occlusive crisis (VOC),     fever (T ≥38.0°C) and serum sPLA2 concentration ≥50 ng/mL.   "
198195|NCT00434486|"     To investigate a potential pharmacokinetic interaction between SKI-606 and ketoconazole when     co-administered.   "
198196|NCT00434499|"     This study will examine whether epigallocatechin gallate (EGCG), a major component of green     tea, affects how the body responds to insulin in healthy and obese people. Insulin is not as     effective in people who are overweight, have high blood pressure or diabetes. This condition     is known as insulin resistance. Laboratory studies suggest that green tea or EGCG treatment     lowers blood pressure, lowers blood sugar and increases blood flow. This study will see if     EGCG improves insulin resistance or insulin's effects on blood flow in people with insulin     resistance.      Healthy normal weight or overweight people between 21 and 65 years of age may be eligible for     this study. Participants are randomly assigned to take EGCG or a placebo ( inactive dummy     pill ) in two 4-week treatment phases with a 2-week period of no study medication before each     treatment phase. After the first 4-week treatment, patients on placebo are switched to EGCG     and those on EGCG are switched to placebo. In addition to treatment, participants undergo the     following procedures during the study period:        -  Screening, including medical history, physical examination and blood and urine tests,          and finger-stick blood sugar measurement for patients with diabetes        -  Complete a dietary and physical activity questionnaire and consult with a dietitian        -  Blood and urine tests        -  At-home and clinic blood pressure monitoring        -  Glucose clamp test to measure how the body responds to insulin. This test is done three          times during the study. A needle is placed in a vein in each of the subject's arms, one          for sampling blood and the other for infusing insulin, glucose and potassium. Glucose          and insulin levels, electrolytes, lipids, fatty acids, cytokines and epicatechin are          measured.        -  Forearm blood flow measurement with microbubbles and ultrasound. Before beginning the          glucose clamp test, a test of how well the blood vessels relax is done. A device that          measures the size of the artery in the upper arm is placed above the elbow. Blood flow          in the muscle of the forearm is measured by ultrasound using a small infusion through a          vein of microbubble contrast agent consisting of gas-filled bubbles the size of red          blood cells. The contrast agent is infused over a 7- to 9-minute period at the beginning          of the glucose clamp test and again 2 hours after the beginning of the test.   "
198197|NCT00434512|"     GSK has constructed a new HIV immunogen comprised of conserved parts of the HIV virus (gag,     pol and nef). The principal objectives of this study are to evaluate the reactogenicity and     safety of this candidate vaccine with or without a GSK proprietary adjuvant system at three     different doses and to evaluate the CD4+ T-cell response in terms of proportion of responders     to the antigens two weeks after the second vaccination.   "
198198|NCT00434525|"     -  The investigators aim to determine the clinical and metabolic effects of sleeve          gastrectomy with or without omentectomy in the treatment of morbid obesity.        -  The investigators hypothesize that the endocrine suppression of ghrelin (appetite          hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy          (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits          for morbidly obese patients.   "
198199|NCT00434538|"     This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the     wound repair of diabetic neuropathic foot ulcers.      The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing     a clinically significant advantage over the standard of care in the repair of diabetic foot     ulcers.   "
198200|NCT00434551|"     This is a prospective study aimed to validate the ability of capsule endoscopy to accurately     diagnose small bowel Crohn's disease in symptomatic patients who have a non-diagnostic     standard workup. Patients will be randomized to undergo capsule endoscopy either one week or     five weeks after enrolment. Patients will be followed up for up to 3 months after capsule     endoscopy.   "
198201|NCT00434564|"     Objective        1. To compare the incidence of adverse cardiac events among the patients discharged after          evaluation through ACTION protocol with those through conventional protocol. The adverse          cardiac events for the follow-up are defined as any of the followings:             -  Cardiac related death             -  Ventricular fibrillation             -  Myocardial infarction             -  Cardiogenic shock requiring the inta-aortic balloon pump circulatory assistance             -  Acute pulmonary oedema requiring endo-tracheal intubation        2. To study the sensitivity / predictive values of the various components of ACTION :12          lead ECG ST monitoring , serial serum markers for myocardial necrosis (myoglobin, CKMB,          TnT, graded exercise testing, stress tetrofosmin scan/ stress echocardiography) in          predicting adverse cardiac events.      Design -prospective randomised clinical trial      Participants      -patients above 25 years of age presenting to the ED with chest pain consistent with     myocardial ischaemia but with a 12 lead ECG non-diagnostic of myocardial ischaemia .      Intervention      Patients were monitored continuously with a 12 lead ECG and ST segment trend monitoring and     blood will be drawn at 0,3,6 hours after arrival at ED for serial myoglobin, creatine kinase     MB isoenzyme (CKMB) and Troponin T (TnT) . Patients who have ECG and blood test consistent     with myocardial necrosis were admitted to the CCU. A senior doctor in the ED reviewed     patients who were not admitted after 6 hours of observation.      Study Group      A stress tetrofosmin nuclear scan was done . Patients were then admitted and discharged     depending on the results of the stress tetrofosmin scan.      Control group (conventional protocol)      Patients were then be admitted or discharged at the discretion of the senior ED doctor.      Measurement Patients were followed up at 1 week , 2 weeks , one month and six months for any     adverse cardiac events such as cardiac related death , ventricular fibrillation , and     myocardial infarction.      Statistical analysis Logistic regression analysis were used to compare the proportion of     adverse events in the two treatment groups.   "
198202|NCT00434577|"     Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK     candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II     study will be subdivided into a primary study (108494) and three extension studies (108516,     108518 & 108520), consisting of one additional visit each at months 12, 24 and 36,     respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the     primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the     GSK1437173A vaccine in healthy elderly population. The study population will be stratified by     age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim     of the extension studies is to evaluate the persistence of the immune response induced by the     candidate HZ vaccine during a long term period.      No new subjects will be enrolled during the extension phases of the study.   "
198203|NCT00434590|"     The study will evaluate kidney graft function in maintenance renal transplant patients.   "
198320|NCT00445107|"     The purpose of this study is to assess the treatment effect of montelukast 10mg on the     primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent     asthma patients with or without allergic rhinitis.   "
198213|NCT00434720|"     The GlideScope video laryngoscope (Verathon) is an intubating device that uses a     high-resolution camera embedded into a plastic laryngoscope blade. An LED provides     illumination. The GlideScope often provides a good laryngoscopic view, but passing the     endotracheal tube (ETT) through the vocal cords is sometimes difficult. Because of the 60     degree anterior curvature of the GlideScope's blade, ETT's must have stylets inserted so that     the ETT distal tip can be positioned anteriorly. Various authors have recommended different     angles of the ETT to optimally place it into the trachea. Previous study demonstrated that 90     degree sharp bend was both faster and subjectively easier in a heterogeneous group of     intubators. With the introduction of a rigid GlideScope Specific Stylet by the manufacturer,     the question arises as to the the best configuration of stylet for the ETT. Therefore, this     prospective, randomized, single-blinded trial is proposed.      The null hypothesis is that there will be no difference between the GlideScope Specific     Stylet and the standard malleable stylet.   "
198204|NCT00434603|"     This study utilizes a novel technique—expressive arts therapy—to facilitate social     integration for youth recovering from acquired brain injury (ABI). Expressive arts therapy is     defined as the use of the arts and artistic media to explore psychological aspects of life.     An expressive art (also referred to as 'creative arts' or even just 'arts') encompasses     drama, music, art (visual arts such as painting, sculpture etc) and dance/movement. It has     great potential to improve community integration for youth recovering from ABI, through     facilitating skills required for successful social communication and social cognition. It is     hypothesized to improve social and emotional functioning compared to a less structured     creative arts program. It is expected that a combination of directed group activities and     self-reflection within a creative learning context will improve emotional awareness and     social and community integration to a greater degree than a non-expressive creative arts     therapy group, in youth who have suffered an ABIAs community integration enables meaningful     and productive occupational engagement, enabling opportunities for occupational engagement     through increased community integration would greatly enhance the quality of life of     adolescents with ABI.   "
198205|NCT00434616|"     Critical limb ischemia is a condition where the blood circulation in the limbs, in most cases     the legs, is decreased so that pain and non healing wounds ensue. Mostly, this is a sequel of     arteriosclerosis and/or diabetes. If surgical and other methods for the improvement of blood     supply for the leg have failed or are not possible, most of these patients will proceed to     amputation of the leg.      Bone marrow contains cells which can induce and augment the growth of new, small arteries     called collateral arteries. It has been shown in animals and in some case series that the     transplantation of a concentrate of the patient's own bone marrow with stem cells into the     ischemic limb can improve the blood circulation via the induction of collateral growth.     However, it is not known if this bone-marrow stem cell induced collateral growth is     sufficient to avoid otherwise necessary amputations.      Therefore, we conduct a study to compare the efficiency of concentrated bone marrow cells     injected into the critically ischemic limb compared to a placebo procedure where only saline     is injected. We think that the transplantation of autologous bone marrow will reduce the     number of necessary leg amputations, reduce pain and induce wound healing. In this     investigation, patients with limb threatening ischemia are randomly allocated either to the     bone marrow group or to the placebo group. Patients in the bone marrow group will have their     bone marrow harvested under sedation, and the bone marrow cells are concentrated. The cell     concentrate will then be injected directly into the muscle of the diseased leg. Patients in     the placebo group will undergo sedation as well but no bone marrow harvest is done, and     saline is injected into the ischemic leg. The procedure will require about 1.5-2 hours, and     the subjects will be admitted to a participating vascular Centre. Monthly examinations up to     three months after the bone-marrow or placebo procedure are done. After the follow-up of     three months, the rate of death and amputations and the wound healing process are compared     between groups. Adverse and serious adverse events will be recorded during this time period.     Diagnostic studies will be obtained to measure blood flow in the treated leg during the     follow up period and include skin oxygen measurements, pressure recordings in the leg and     arteriography. Also, quality of life, pain and wound healing will be assessed.      After completion of the three months study participation, subjects who have been treated with     placebo will be able to receive open-label bone marrow transplantation therapy.   "
198206|NCT00434629|"     Patients with B-cell lymphoma who relapse after autologous transplant tend to have a poor     prognosis. Currently, there is no standard treatment for such patients. Bexxar is a     radioactive antibody therapy that has shown a 60-80% response rate in non-transplanted     patients with relapsed B-cell lymphoma. This study will test the safety and efficacy of     Bexxar in the treatment of patients whose B-cell lymphoma has relapsed after an autologous     transplant.   "
198207|NCT00434642|"     This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the     safety and efficacy of bevacizumab, administered in combination with carboplatin with     gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary     peritoneal, or fallopian tube carcinoma.   "
198208|NCT00434655|"     -  The investigators aim to determine the clinical and metabolic outcomes of two available          bariatric restrictive procedures: laparoscopic adjustable gastric banding (LAP-BAND) and          laparoscopic sleeve gastrectomy for the treatment of morbid obesity (BMI > 35 with          comorbidities or BMI > 40) in VETERANS.        -  The investigators hypothesize that the short and long term outcomes between laparoscopic          adjustable gastric banding (LAP-BAND) and sleeve gastrectomy are similar in VETERANS.   "
198209|NCT00434668|"     The aim of this study is to evaluate the tolerability (in terms of drug delivery and     toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely     resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients     will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.   "
198210|NCT00434681|"     Evaluate the acceptability over 24 hours of a new paracetamol formulation 4.8% paediatric     oral suspension in children weighing between 3 and 26 kg including limits   "
198211|NCT00434694|"     This is a study of different techniques for treatment of atrial fibrillation using a     procedure called radiofrequency catheter ablation. Atrial fibrillation (called AF) is when     the upper chambers of the heart (the atria) beat much faster than the lower chambers, causing     the heart to beat less effectively. AF can cause stroke, impaired performance, palpitations,     shortness of breath, passing out and other symptoms. Radiofrequency ablation involves     placement of catheter/electrode wires into the heart through plastic tubes inserted into     veins / arteries in both the groins and the right side of the neck under local anesthesia.     Radiofrequency energy is delivered to the areas inside the heart that cause the rapid firing     of the atria, causing small lesions or burns that destroy the heart tissue where the extra     electrical impulses come from. Commonly this area is where the four pulmonary veins (PV)     deliver blood from the lungs to the left side of the heart, and the procedure is also     referred to as pulmonary vein isolation or PVI.      This study compares two different strategies for performing the pulmonary vein isolation     procedure, and compares the effect using two different types of radiofrequency ablation     catheters.   "
198321|NCT00445120|"     This interventional study aims to evaluate the efficacy of oral administration of     Lactobacillus Rhamnosus GG in preventing relapses of ocular inflammation in Vernal     Keratoconjunctivitis (VKC) patients.   "
198212|NCT00434707|"     Small pupils are not uncommon in situations requiring surgical intervention for glaucoma and     cataract. Inadequate binocular view during combined trabeculaectomy and glaucoma surgery     needs to be overcome by additional iris manupulations to dilate the pupils which increase the     liklihood of inflammation, inraocular pressure rise after surgery and enhnced liklihood of     failure of glaucoma surgery. The proposed trial is an observational study to analyse post     operative outcome of eyes undrgoing trabeculectomy and phacoemulsification with intraocular     lens implantation with small pupils in persons with glaucoma coexisting with cataract.   "
198214|NCT00434733|"     This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of     FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3     weeks apart.   "
198215|NCT00434746|"     The purpose of this study is to assess the safety and tolerability of ascending single IV     doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects.   "
198216|NCT00434759|"     Primary objective:      The purpose of this study is to examine efficacy and efficiency of a Stepped Care Program     (SCP) for patients with Social Phobia in comparison to the standard cognitive therapy for     Social Phobia according to D.M. Clark.      Secondary objective:      Further, it is intended to identify mechanisms of change which mediate treatment outcome and     to identify differential predictors for therapy success for the two treatment conditions.   "
198217|NCT00434772|"     Thesis Infants of diabetic mothers are at high risk to develop hypoglycemia after birth.      After birth, glucose and ketone bodies are the main substrates of brain energy. Under normal     condition, the adrenergic response seen immediately after birth suppresses insulin release     and stimulates glucagon secretion which enhances gluconeogenesis and ketogenesis.      An inversion of the insulin/glucagon ratio is seen soon after birth as a normal, physiologic     phenomenon. Consequently, a post delivery glucose nadir is reached between 30 to 90 minutes     after birth, followed by a spontaneous recovery before 3-4 hours of age.      In infants of diabetic mothers, this inversion of the ratio is postponed and a more profound     and sustained hypoglycemia is seen.      Early feeding is of great importance to diminish the severity and incidence of hypoglycemia.     But, if despite an appropriate calorie intake, low levels of sugar are seen, an intravenous     infusion of glucose should be commenced. In case that IV glucose is not effective or can't be     supplied immediately, intramuscular glucagon is a therapeutic alternative.      We hypothesize that a single intramuscular injection of glucagon together with the     appropriate oral intake of nutrients is a safe and an effective alternative to the IV     infusion of glucose alone in the treatment of hypoglycemia in term infants of diabetic     mothers.      Methods Appropriately grown or large for date, term infants of insulin treated diabetic     mothers, with no other known medical problems, are potential candidates for our study.      Hypoglycemia will be defined as serum glucose level lower than 45 mg%. Infants of diabetic     mothers will arrive to the nursery and immediately receive early feeding before 30 minutes of     life. At that time, glucose will be checked. If glucose level is lower than 45 mg%, treatment     with IV glucose or IM glucagon will be initiated. Glucose will be checked every hour for 4     hours and then every 3 hours (before each meal) for the next 20 hours.      In case blood glucose level is lower than 20 mg% or falls below 45 mg% despite glucagon     treatment, IV glucose will immediately be instituted.      Our aim is to check that IM Glucagon is as good as IV glucose in the treatment of     hypoglycemia in infants of diabetic mothers. We will compare glucose levels after treatment     with IV glucose and IM glucagon, the time till normalization of glucose and full feeding is     achieved and the number of hospitalization days in both groups.   "
198218|NCT00434785|"     To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy     Japanese subjects.   "
198219|NCT00434798|"     The primary objective of this study is to establish a human Campylobacter jejuni infection     model with the following characteristics:        1. Safe application             1. Infectious period risk mitigated by close monitoring and prospectively applied               early treatment criteria             2. Potential post-infectious sequelae risk mitigated by appropriate strain and host               selection        2. Campylobacteriosis attack rate of at least 75%      Secondary objectives are to determine humoral, cell-mediated, and mucosal immune responses in     the newly established human C. jejuni infection model and evaluate short-term (< 3 mo)     protection upon repeat exposure to homologous C. jejuni strain and assess immune responses     associated with protection.   "
198220|NCT00434811|"     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells     are destroyed, resulting in poor blood sugar control. The purpose of this study is to     determine the safety and effectiveness of islet transplantation, combined with     immunosuppressive medications, for treating type 1 diabetes in individuals experiencing     hypoglycemia unawareness and severe hypoglycemic episodes.   "
198221|NCT00434824|"     In this study we have evaluated the effects of three different doses of oral testosterone     undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism     and low blood levels of the male hormone testosterone.      Specifically, we have studied the effects on:        -  symptoms suggestive of low testosterone levels        -  blood testosterone and other hormone levels        -  bone mass        -  muscle mass and fat mass        -  muscle strength        -  prostate        -  lipids, hematocrit   "
198222|NCT00434837|"     The anterior cruciate ligament (ACL) is one of four strong ligaments connecting the bones of     the knee joint. If overstretched, the ACL can tear. Reconstruction of a torn ACL is now a     common surgical procedure. The amount of tension applied to the ACL during reconstruction may     indirectly affect the possible onset of arthritis over time. The purpose of this study is to     determine the effect of initial graft tension set during ACL reconstruction surgery on the     progression of knee arthritis over at least a 12-year period.   "
198223|NCT00434850|"     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells     are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess     the safety and efficacy of deoxyspergualin (DSG), an immunosuppressant drug, on     post-transplant islet function in people with type 1 diabetes who have not responded to     intensive insulin therapy.   "
198224|NCT00434863|"     The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and     EMG activity.   "
198225|NCT00434876|"     The primary purpose of this study is to determine how efficacy of quetiapine (seroquel XR) in     improving the sleep in recovering alcohol dependent subjects.   "
198226|NCT00434889|"     The purpose of this study is to identify the factors that are associated with falls and near     falls in community-dwelling older adults with early-stage dementia.   "
198255|NCT00441675|"     The CATO population is a very well documented population during two years. During this study     patients were treated according to the CATO algorithm, after that patient were treated     according to the Dutch national (GINA derived) guidelines up to 6 years of follow-up. The     purpose of this prospective follow-up study is to understand the long-term effects of     treatment. Therefore the measurements done at baseline (CATO part 1) are repeated after 6     years in this CATO-population (CATO follow-up).   "
198627|NCT00448513|"     The purpose of this study is to clarify the effects of tea catechin extracts on the frequency     changes of micronuclei in peripheral lymphocytes compared with other oxidative stress markers     in late middle aged healthy volunteers   "
198227|NCT00434902|"     Recent data show that pulmonary hypertension (PH), defined by a tricuspid regurgitation jet     (TRJ) velocity > or equal at 2.5m/s on Doppler echocardiography, is present in about 30% of     adults with sickle cell disease (SCD) and is associated with poor prognosis. However in SCD     the occurrence of PH (defined by mean pulmonary arterial pressure (mPAP)> or equal at 25     mmHg) is related to at least 3 mechanisms: PH due to hyperkinetic state with high cardiac     output (CO) but normal pulmonary vascular resistance (PVR <160 dynes), or postcapillary PH     (pulmonary capillary wedge pressure PCWP >15 mmHg), or precapillary pulmonary arterial     hypertension (PAH) defined by mPAP > or equal at 25 mmHg, PCWP< or equal at 15 mmHg and PVR >     or equal at 160 dynes.The aim of this study is to evaluate in a French population of adults     with sickle cell disease the characteristics, prevalence and prognosis of pulmonary     hypertension.   "
198239|NCT00441467|"     Primary Objective:      1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as     measured by objective response rate      Secondary Objectives:        1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma          as measured by duration of response, progression-free survival and overall survival        2. To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma      Exploratory Objectives:        1. To evaluate the biological effect of glufosfamide on the metabolic profile in subjects          with advanced soft tissue sarcomas, as determined by FDG-PET        2. To correlate efficacy endpoints with expression of tumor-associated glucose transporter          proteins   "
198228|NCT00434915|"     Dehydroepiandrostrone (DHEA) and its sulfated ester (DHEAS) are high circulating weak     androgens which have been associated with conditions that accompany age-related decline such     as sarcopenia, hyperinsulinemia, osteopenia, and cardiovascular disease. The decline in DHEA     with age is particularly marked in postmenopausal women. Exercise has always been advocated     in women; benefit has been demonstrated inmuscle, bone and lipid physiology, as well as     perception of energy and sense of well-being. This study aims to explore the combined effect     of both DHEA and exercise in postmenopausal women, age range 55-75 years old. Subjects will     receive DHEA (50mg/day) or placebo for a 12-week period. At the beginning and conclusion of     the study patients will undergo testing for muscle strength, body composition, VO2 max,     insulin sensitivity, muscle biopsy with mitochondria enzyme measurements, and psychological     analysis. Blood samples pre and post intervention will also be obtained and the level of     selected anabolic markers, lipids, and androgenic and sex steroid levels will be assessed.     For the twelve-week period, both placebo and DHEA treated participants will be involved in a     resistance and aerobic exercise program coordinated through the GCRC and the Dan Abraham     Healthy Living Center. Several correlations have been established with respect to exogenous     DHEA administration in postmenopausal women. None have evaluated oral DHEA therapy in the     setting resistance and aerobic exercise, key therapies advocated in postmenopausal women. As     a plausible anabolic hormone DHEA is hypothesized to accentuate the effects of exercise as     has been shown for testosterone. This study, as a randomized double-blind placebo controlled     trial, will investigate the effects, if any, of a regimented exercise program and DHEA     supplementation in postmenopausal women, specifically for evidence of enhancement of exercise     effect by oral supplementation with DHEA in attenuating age-related decline   "
198229|NCT00434928|"     Assess the dietary intake of children aged 6-12 years by means of a 24-hour recall and 3-day     food record and asses the nutrient status of Vitamin B6, serum ferritin, serum zinc and serum     copper of the same children by means of standard laboratory assessments.   "
198230|NCT00434941|"     This is a prospective, open-label, multicenter phase IV.II study. Patients with local relapse     breast cancer will receive radiotherapy concomitant to the administration of capecitabine.     Total dose of radiotherapy will be 50 Gy administered in daily session of 200 cGy.     Radiotherapic treatment will not be longer than 6 weeks.      All patients will receive 1650 mg/m2 by mouth, per day (825 mg/m2 twice a day (p.o. bid) for     35 days.      Tissue samples must be analysed to determinate the human epidermal growth factor receptor-2     (HER2)by FISH technical.   "
198231|NCT00434954|"     This study in Germany is designed to compare the effects of twice-daily exenatide plus     metformin and twice-daily premixed human insulin aspart plus metformin with respect to     glycemic control, as measured by HbA1c, combined with the percentage of patients with at     least one treatment-emergent hypoglycemic episode. Patients will be treated with study     therapy for approximately 26 weeks.   "
198232|NCT00434967|"     The aim is to compare the blood pressure lowering effect of the combination of candesartan     cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg to that of candesartan 32     mg alone, HCT 25 mg alone and placebo in hypertensive adults.   "
198233|NCT00441389|"     To assess the infectious etiology related to acute exacerbation of COPD in Hong Kong   "
198234|NCT00441402|"     This study investigates the role of energy balance and stress in the regulation of     hypothalamic-pituitary-gonadal axis in adolescent girls across the fitness spectrum.   "
198235|NCT00441415|"     The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% /     Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in     Subjects with acne vulgaris after a 12-week treatment period.   "
198236|NCT00441428|"     Detrusor underactivity (DUA) in men is responsible for LUTS in a significant minority, the     symptoms being indistinguishable from those seen in BOO. The International Continence Society     (ICS) defines DUA as 'a detrusor contraction of inadequate magnitude and/or duration to     effect complete bladder emptying in the absence of urethral obstruction. Whilst a reduced     maximum urinary flow rate (Qmax) is indicative of voiding dysfunction, flow studies cannot     distinguish between DUA and BOO, which are the two principal causes of low flow rates. DUA is     diagnosed from a pressure-flow study (PFS)and is characterized by a low-pressure, poorly     sustained, or wave-like detrusor contraction with an associated poor flow rate.      Overactive bladder (OAB) is the most common term currently used in clinical medicine to     describe a complex of lower urinary tract symptoms (LUTS) with or without incontinence but     most commonly consisting of urgency, frequency, nocturia, troublesome or incomplete     emptying,and, occasionally, pain. With the exception of pain and incontinence, these symptoms     are often found together; thus, the term LUTS has come to replace previous terms, such as     urgency-frequency syndrome,urethral syndrome, and prostatism.      Drug treatment is frequently used as the initial management approach for LUTS in older     men.Among men who desire treatment, general practice prescribing data have shown that     antimuscarinics are not often given to elderly men. There is theoretical concern that the     inhibitory effect of antimuscarinics on detrusor contraction could aggravate voiding     difficulties or cause urinary retention in patients with BOO. There are virtually no data     evaluating the safety and efficacy of solifenacin treatment in men with DUA and OAB.   "
198237|NCT00441441|"     This study is to assess the safety of an investigational drug in children 4 to 11 years of     age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in     the morning, and have lung function tests performed.   "
198238|NCT00441454|"     The so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become     a standard operation worldwide for the treatment of women with stress urinary incontinence.     This tape is placed from the vagina behind the pubic bone and exits through the skin of the     lower abdomen, just above the pubic bone. In 2001 a urologist in France proposed passing a     similar tape laterally (as opposed to behind the pubic bone). This tape is passed through a     window of the pelvic bones (the so-called obturator foramen), by what is called a     transobturator approach. It is passed through the skin of the thigh (as opposed to the lower     abdomen). The reason for this modification was to avoid injuring the bladder and, possibly,     provide a more physiologic restoration of the continence mechanism. However, it is unclear     whether the lateral (so-called transobturator approach) is as good as or better than the     initial approach behind the pubic bone.      The purpose of the present study is to compare the standard (retropubic) and the newer     (transobturator) approach for the placement of a tape for treating women with stress urinary     incontinence.   "
198240|NCT00441480|"     The purpose of this study is to determine whether plant sterols esterified to fish oil fatty     acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG     concentrations in healthy hyperlipidemic subjects.   "
198241|NCT00441493|"     This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.   "
198242|NCT00441506|"     Critically ill children are often sedated in order to relieve them from anxiety and     discomfort, and to facilitate their care. There is little information on the effects of     prolonged and continuous use of sedatives and analgesic agents in critically ill children. In     adult intensive care unit (ICU) patients, daily interruption of sedative infusions     accelerates recovery resulting in a reduction in the average duration of mechanical     ventilation of 2.4 days as well as a reduction in average ICU length of stay of 3.5 days.     These results were achieved without an increased rate of adverse events potentially linked to     less sedation and associated with a reduction of common complications of critical illness and     without negative psychological effects.      It is unknown whether these results can be extrapolated to critically ill children. Moreover,     the possible risk of complications associated with less sedation, such as accidental     self-extubation, is probably higher in children. Also, the need for intermittent bolus     administrations in children treated with intermittent sedation could nullify the reduction in     the use of sedatives.      It is unknown if daily interruption of sedatives is feasible in critically ill children. The     researchers studied the effects of daily interruption of sedatives in critically ill children     on the total amount of sedatives used and risks of complications.   "
198243|NCT00441519|"     To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet   "
198244|NCT00441532|"     Patients at risk for having prostate cancer usually undergo a biopsy of their prostate. This     is most often done in the private urology office. Recent studies have suggested that     injection of local anesthesia (lidocaine) near the nerves of the prostate will improve pain     sensation during the biopsy procedure. Local anesthesia can be given through a separate     needle through the rectal probe just prior to biopsy. However, many urologists to date     perform their biopsies without anesthesia. Some claim that the needle used for anesthesia     causes pain itself. Others claim that the pain is so minimal that the additional use of     lidocaine (and extra time) is not necessary. We plan to reexamine the use of lidocaine and     perform the first study where each patient will receive lidocaine and placebo on separate     sides of their prostate.   "
198245|NCT00441545|"     To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the     reduction of serum phosphorus levels from baseline.   "
198246|NCT00441558|"     To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness     of Flibanserin in Women with HSDD that have already completed a previous study     (511.70/71/.74/.75/.105) with Flibanserin.   "
198247|NCT00441571|"     The proposed phase 1 clinical trial will investigate the safety and tolerability of     177Lu-CYT-500 in patients with metastatic prostate cancer and determine the optimal antibody     mass and dose of 177Lu to be used for further study.   "
198248|NCT00441584|"     This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate     the efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C. The     study is designed to determine the proportion of chronic hepatitis C genotype 1 subjects who     did not respond to previous treatment with Pegasys 180µg QW plus ribavirin, that will achieve     sustained virological response (SVR) when treated with PegIntron plus Rebetol.   "
198249|NCT00441597|"     To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after     ischemic exercise in the non-dominant forearm.   "
198250|NCT00441610|"     CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in     Japanese patients.   "
198251|NCT00441623|"     Study on the natural history of uremic retention solutes in patients with mild-to-moderate     chronic kidney disease   "
198252|NCT00441636|"     The purpose of the study is to determine the effect on mood and anxiety symptoms of adding     CPAP to the psychiatric treatment of patients with TRD (treatment resistant depression) and     associated OSA (obstructive sleep apnea).   "
198253|NCT00441649|"     This study will evaluate the safety and effectiveness of methylphenidate in treating     attention deficit hyperactivity disorder in children with both attention deficit     hyperactivity disorder and Tourette syndrome.   "
198254|NCT00441662|"     Melanoma is the most common primary tumour which occurs inside the eye. For over 20-years, it     has been possible, in many cases, to use local delivery of radiation to the eye to treat this     type of tumour, avoiding the need to surgically remove the affected eye. This treatment,     however, is often complicated by radiation-induced loss of vision, months or years after     treatment.      The aim of this research project is to investigate the potential prevention of radiation     complications in the eye by giving anti-inflammatory medication (a long-acting steroid) in     the form of a local injection around the eye at the time of treatment, and at 4-months and     8-months following treatment. This medication (named ‘triamcinolone’) has been successfully     used to treat similar complications of diabetic eye disease, for example, and has a good     safety profile.      The rationale of this study is to attempt to preserve vision, in addition to preserving the     eye, in patients affected by this eye tumour, and therefore preserve quality of life for     these patients.   "
198256|NCT00441688|"     This study is a cross sectional observational study to evaluate the prevalence of HLA-B*5701     in the major French ethnotypes.      Any HIV-1 infected subject will be eligible for this study including antiretroviral therapy     (ART) naÃ-ve and experienced subjects irrespective of abacavir use, as well as subjects     previously tested for HLA-B*5701. Subjects will be approached during a standard clinic visit,     and all subjects will be consented prior to any study specific procedure. Subjects will be     asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess     HLA-B*5701 status by central and local methodologies.   "
198317|NCT00445068|"     This study will evaluate the efficacy and safety of LBH589B in adult patients with multiple     myeloma who have received at least two prior therapies and are refractory to their last     therapy. Patients must have received in prior therapy either bortezomib or lenalidomide   "
198257|NCT00441701|"     This is a two-part study conducted at multiple centers, of navarixin (SCH 527123, MK-7123) in     participants with moderate to severe chronic obstructive pulmonary disease (COPD). Part 1 of     the study is a double-blind, placebo-controlled, randomized, rising-dose study consisting of     four treatment groups enrolled in three cohorts. The duration of treatment, for each cohort,     will be a 2-week run-in period, followed by a 12-week double-blind treatment period.     Treatment initiation for each cohort was staggered by 4 weeks to allow for safety assessment     prior to use of higher doses of navarixin. Part 2 of the study will be a double-blind,     placebo-controlled, randomized, parallel group study consisting of four treatment groups     enrolled as one cohort. The duration of treatment will consist of a 2-week run-in period,     followed by a 12-week double-blind treatment period.   "
198258|NCT00441714|"     To adjust our forearm model for ischemia reperfusion injury, in order to used it for     assessment of ischemia reperfusion damage in elderly and patients.      To test the effect of ischemic postconditioning on ischemia reperfusion injury in healthy     volunteers, using Annexin binding after repetitive handgripping.   "
198259|NCT00444301|"     Heart failure, a chronic illness afflicting 5 million persons in the United States is known     to cause shortness of breath and fatigue, yet at least half of persons with heart failure     also report the presence of pain.      The cause of pain for these persons is not clear. PAIN-HF (Pain Assessment, Incidence &     Nature in Heart Failure), conducted through the Palliative Care-Heart Failure Education And     Research Trials (PC-HEART) collaborative will identify the prevalence of pain, its location,     severity and impact on activities and the possible causes of pain in persons living with     heart failure. The study will also try to understand relationships between other problems and     pain, as well as what treatments are given to reduce pain.      Understanding sources of pain and its characteristics is the first step in helping health     care providers better manage pain and related problems in persons with heart failure.   "
198260|NCT00444314|"     This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and     pharmacodynamics, of Panzem® NCD with or without Sunitinib Malate in patients with metastatic     renal cell carcinoma progressing on Sunitinib Malate.   "
198261|NCT00444327|"     The aim of our study was firstly to detect in cord bloods the polymorphism of genes related     to atopy and allergic diseases and to examine their mutual interaction and their associations     with cord blood IgE and cytokines. After that, in the prospective follow-up visits, we liked     to investigate if the measurement of cord blood SNPs of genes related to atopy and allergic     diseases was helpful in predicting the development of atopy and allergic diseases later in     life.   "
198262|NCT00444340|"     This study is an extension trial of 0881A3-312-EU and is designed to provide information on     the safety and efficacy of etanercept in patients with ankylosing spondylitis for up to 3     additional years.   "
198263|NCT00444353|"     This study is being undertaken to:        -  evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic          acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment          of dermal nasolabial fold wrinkles at 13 months following the last application of study          treatment.        -  Document the types and incidence of adverse events reported with DL6049 (injectable          poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events          will be assessed for an additional 12 months following discharge from the main study in          subjects treated with DL6049.   "
198264|NCT00444379|"     The primary purpose of this study is to determine whether a protease inhibitor-based     antiretroviral regimen is more efficacious than a non-nucleoside reverse transcriptase     inhibitor-based antiretroviral regimen in promoting the regression of KS tumor burden in     persons with AIDS-related KS in Africa.   "
198265|NCT00444392|"     Central hypothesis is: Gastric bypass surgery reduces the risk of CVD in morbidly obese     subjects (defined as BMI ≥35 kg/m2) with T2DM.      To determine whether surgically induced weight loss decreases the risk of CVD in morbidly     obese subjects with T2DM. I hypothesize that patients with T2DM who undergo gastric bypass     surgery will significantly reduce mean levels of risk factors for CVD compared with diabetic     individuals with the same BMI who maintain their weight.   "
198266|NCT00444405|"     The purpose of this study is to compare patients who underwent decompression/discectomy with     pedicle screw fusion to patients who received decompression/discectomy without fusion.   "
198267|NCT00444418|"     The purpose of this study is to study the effectiveness of medication and specialized     psychotherapy in helping gay and bisexual men who do not want to quit drinking learn how to     reduce their drinking to healthier levels. More information on the study is available at     www.projectsmartnyc.org.   "
198268|NCT00444431|"     In this randomized trial surgical therapy and surveillance of ureteropelvic junction     obstruction will be compared, regarding partial renal function.   "
198269|NCT00444444|"     To determine whether certain alleles or haplotypes of major histocompatibility complex gene     are associated with AIP in Korean population, we undertook this study with high-resolution     typing for HLA (sequence-based typing).      Primary outcomes: detection of novel allele associated with AIP in Korean population     Secondary outcomes: detection of genetic factor for relapse of AIP during steroid treatment   "
198270|NCT00444457|"     The purpose of this study will be to evaluate safety, tolerability and immunogenicity of     three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied     for consistency of the immune response, as well as for non-inferiority and safety as compared     to 7-valent Pneumococcal Conjugate Vaccine.   "
198271|NCT00444470|"     Spinal fusion surgery can be associated with significant blood loss requiring allogeneic     blood transfusion. Tranexamic acid is a synthetic amino acid with antifibrinolytic action     that has been shown to reduce perioperative blood loss in patients undergoing cardiopulmonary     bypass for cardiac bypass surgery, knee replacement and liver transplantation surgeries. The     efficacy of antifibrinolytics for reduction of blood loss in major spine surgery has not been     well studied in adult patients. The objective of this study is to determine the efficacy of     tranexamic acid in reducing perioperative blood loss and blood transfusion in adults     undergoing elective spinal fusion in a larger, multi-centered, randomized, double-blinded,     placebo controlled trial.   "
198318|NCT00445081|"     To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients     with severe atopic dermatitis.   "
198272|NCT00444483|"     The improvement of the quality of life (QoL) is one of the key treatment goals in patients     with diabetes mellitus. Objective: Prospective study to evaluate the impact of structured     diabetes education on the QoL in insulin-treated, elderly patients with type 2 diabetes     mellitus. Inpatients with insulin treated type 2 diabetes or failure of oral antidiabetic     therapy were successively recruited and participated in the structured inpatient diabetes     treatment and teaching program (DTTP) for insulin therapy QoL was assessed before and six     months after participation in the DTTP with the standardised questionnaire of Lohr analysing     the subscales: social relations, physical complaints, worries about the future, diet     restrictions, fear of hypoglycemia, and daily struggles.   "
198273|NCT00444496|"     We are collecting baseline data on patients who have high blood pressure readings (160/100 or     higher) at a 9-1-1 response by an EMT.   "
198274|NCT00444509|"     This is a single centre, randomised, double blind, two-way crossover study, to investigate     the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder     GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to     improve the physical stability of inhaled dry powder formulations. Male and female patients     with mild/moderate asthma will be randomised to determine which order they receive a single     inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will     be a wash-out period of at least 5 days between doses.   "
198275|NCT00444522|"     We are developing Staccato Alprazolam for the acute treatment of panic attacks associated     with panic disorder.   "
198276|NCT00444535|"     This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with     ErbB2-overexpressing breast cancer.   "
198277|NCT00444548|"     [S,S]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in     healthy volunteers using a novel methodology   "
198278|NCT00444561|"     This exploratory study is designed to evaluate various pharmacodynamic effects of     subcutaneously (SC) infused or injected pramlintide in obese, nondiabetic male and     postmenopausal female (not on hormone replacement therapy) subjects. The study will also     assess the safety and tolerability of pramlintide administered by SC infusion or injection.   "
198279|NCT00444574|"     Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference     to CONCERTA® in pediatric subjects diagnosed with ADHD.   "
198280|NCT00444587|"     This 2 arm study will compare the efficacy and safety of continuation or discontinuation of     Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive     metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus     Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment     (6mg/kg iv infusion every 3 weeks) while receiving second-line chemotherapy of the     investigator's choice. The anticipated time on study treatment is until disease progression,     and the target sample size is 100-500 individuals.   "
198281|NCT00444600|"     The purpose of the study is to find out which is a better treatment for diabetic macular     edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone,     laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of     ranibizumab alone. At the present time, it is not known whether intravitreal steroid or     anti-vascular endothelial growth factor (anti-VEGF) injections, with or without laser     treatment, are better than just laser by itself. It is possible that one or both of the types     of injections, with or without laser treatment, will improve vision more often than will     laser without injections. However, even if better vision outcomes are seen with injections,     side effects may be more of a problem with the injections than with laser. Therefore, this     study is conducted to find out whether the benefits of the injections will outweigh the     risks.   "
198282|NCT00444613|"     The purpose of this study is to investigate the efficacy and confirm the safety of E0302 in     patients with Amyotrophic Lateral Sclerosis (ALS) by assessing changes in scores of survival     rate and functional rating scale.   "
198283|NCT00444626|"     The purpose of this research study is to evaluate the safety and effectiveness of injection     with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery)     as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal     filler) in patients undergoing cutaneous correction of the nasolabial folds (NLFs).   "
198284|NCT00444639|"     The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for     a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is     a hormone secreted by hypothalamus (a gland located in brain) and controls the production of     sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate     cancer cells, one of the most common cancers in men, is induced by the hormone testosterone.     Hormonotherapy is one of treatments available to treat this type of disease by controlling     the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this     type of injection is not suitable for every patient. Therefore the primary purpose of this     study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin®     11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg     administered via standard intramuscular (IM) injection based on the percentage of patients     presenting a testosterone level ≤ 50 ng/dl at week 24.   "
198303|NCT00444886|"     The purpose of this study is:        1. To assess the effect of BOTOX injection to the scalene muscles on the severity of pain          from TOS.        2. To assess the effect of BOTOX injection on numbness and tingling and quality of life.   "
198285|NCT00444652|"     This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types     of bariatric surgery.      - gastric banding and gastric bypass on anti-Xa activity levels      The study includes two groups of 150 patients scheduled for gastric banding or gastric     bypass.      Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order     to determine the best prophylactic regimen allowing expected values ranged between 0.3 and     0.5 IU / ml.   "
198286|NCT00444665|"     Examine the safety, tolerability and efficacy of travoprost benzalkonium chloride (BAK) free     ophthalmic solution compared to either latanoprost or bimatoprost monotherapy.   "
198287|NCT00444678|"     This trial will examine the addition of Cetuximab in combination with Oxaliplatin and     Capecitabine for treatment of patients with previously untreated metastatic colorectal     cancer.   "
198319|NCT00445094|"     The primary objective of this study is a comparison between MK0787B and standard therapy.   "
198288|NCT00444691|"     It has been reported recently that the detection of synovitis by ultrasonography was more     sensitive than clinical examination (Wakefield et al. Ann Rheum Dis).      An OMERACT and EULAR working party recently produced guidelines on the best way to record and     score quantitatively synovitis of the small joints of the hands and feet (Wakefield R,     D'Agostino MA).      It has also been presumed recently that ultrasonography was more sensitive to changes than     clinical examination after anti-TNF treatment (Ref. Taylor et al). If this better sensitivity     to change were to be confirmed, ultrasonography would be preferred to clinical examination in     studies evaluating new treatments.      In everyday practice, better intrinsic validity of the evaluation of synovitis by     ultrasonography would lead to widespread use of this technique in the diagnosis and treatment     of rheumatoid arthritis patients.      Objective of this study is to compare the sensitivity to change in synovitis score according     to the monitoring method used (clinical examination versus ultrasonography).   "
198289|NCT00444704|"     The primary purpose of this study is to assess the safety and tolerability of ascending     single oral doses of PRA-027 in healthy Japanese females. The secondary purpose is to provide     the initial pharmacokinetic and pharmacodynamic profiles of PRA-027 in healthy Japanese     female subjects.   "
198290|NCT00444717|"     The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of     pitavastatin in hypercholesterolemic patients with the metabolic syndrome.   "
198291|NCT00444730|"     The purpose of initiating the urology database is to collect relevant retrospective data via     chart review related to patients undergoing radical prostatectomy via the retropubic,     perineal, laparoscopic, and robotic assisted laparoscopic approaches and InterStim     implantation. This data will be utilized to evaluate the health benefits and outcomes of each     of these procedures to enhance care and treatment.   "
198292|NCT00444743|"     The purpose of this study is to evaluate the tolerability, pharmacokinetics,     pharmacodynamics, and biologic activity of MM-093 in patients with moderate to severe     uveitis.   "
198293|NCT00444756|"     This trial is a comparison of the anesthetic effectiveness of J-Tip needle-free jet injection     of 1% buffered lidocaine to the anesthetic effectiveness of topical 4% ELA-Max for peripheral     intravenous catheter (PIV) insertion. The researchers hypothesize that the jet injection of     lidocaine will provide superior anesthesia to the ELA-Max prior to PIV insertion.   "
198294|NCT00444769|"     This phase IIa (proof of concept) study will be conducted as a multi-centre study within the     European Union (EU). It will be conducted to a randomised, single blind, placebo- controlled,     parallel group design with a positive control arm to evaluate the analgesic efficacy of     pre-emptive doses of GW842166 following dental surgery (3rd molar tooth extraction). GW842166     will be administered as a single pre-operative oral dose in male and female subjects who will     be randomised to take part in one of four possible treatment regimens. Pain assessments will     be undertaken over a 10 hr period. Pharmacokinetic blood samples will be collected over a 48     hr period. Safety and tolerability will be evaluated by adverse event monitoring,     cardiovascular assessments (ECG and vital signs) and clinical laboratory tests (haematology,     clinical chemistry and urinalysis).   "
198295|NCT00444782|"     The purpose of this study is to investigate the efficacy of GV1001 in locally advanced or     metastatic HCC. Also the safety of GV1001 and immunogenicity will be evaluated.   "
198296|NCT00444795|"     To monitor use in real practice including adverse events and efficacy on Sutent capsules     (Sunitinib malate)   "
198297|NCT00444808|"     This study, which will be conducted at the emergency room of the Sacré-Cœur hospital,     requires the recruitment of 60 subjects and involves some telephone follow-up.      Calcitonin administered as an intranasal spray is already used to relieve pain caused by     broken vertebrae and we seek to determine if it can be as efficient in the case of pain     caused by broken ribs.This study aims at testing the hypothesis that subjects suffering from     the accidental fracture of one or more ribs will get relief through the intranasal spraying     of calcitonin and/or will use less opiate medication for pain relief (a combination of     oxycodone chlorhydrate and acetaminophen called Percocet®).   "
198298|NCT00444821|"     The purpose of this study is to compare endovascular repair using any FDA approved Medtronic     AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic     aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.   "
198299|NCT00444834|"     The purpose of this study is to compare the efficacy of the Egalet® controlled release     formulation to an immediate release Carvedilol tablet.   "
198300|NCT00444847|"     The exposure of human beings to markedly altered environments (ambient pressure and inhaled     gas mixtures) has profound effects on their innate immune capacity to effectively combat     viral illnesses. This Phase IIA clinical trial examines the effects of an exposure to a 4     atmospheric environment has on HIV-infected humans whose clinical condition has progressed to     formal AIDS status.   "
198301|NCT00444860|"     The purpose of this study is to obtain safety and immunogenicity data for the     refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.   "
198302|NCT00444873|"     A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy     and safety of different dose-intervals of Lanreotide Autogel 120mg according to international     standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.   "
198322|NCT00445133|"     HYPTHOTHESIS:      The researchers hypothesize that application of active magnetic therapy vs. sham utilized     while individuals sleep can reduce neuropathic pain in the spine and improve the quality of     sleep. The null hypothesis is that treatment of subjects with spine pain with exposure to     permanent/static magnetic fields has no measurable effect on neuropathic pain scores or     quality of sleep scores.   "
198304|NCT00444899|"     Worldwide, health systems and practitioners are facing obesity epidemics. High blood     pressure, dyslipidemia and diabetes prevalence will explode during the 21st century.      The two main objectives of this 2-year controlled prospective study are:        1. to demonstrate that, for patients with high blood pressure, diabetes and dyslipidemia,          dietician conducted survey and management in combination with annual endocrinologist          follow-up enable both attainment and maintenance of recommended blood pressure, glycemic          and lipid goals, as well as smoking cessation;        2. to demonstrate that dietician management is more cost effective than conventional care          provided by general practitioners and endocrinologists.      Results are expected to show significantly different cardiovascular risk profiles (BMI and     waist circumference, systolic and diastolic blood pressure, LDL-C, triglycerides and Total     cholesterol/HDL ratio, HbA1c, smoking) between baseline and after 2 years follow-up. Sample     size was determined in order to show statistically significant differences between the two     groups.      Results will document for the benefit of care givers, health economists and policy makers     alike an innovative and integrated model of care which is expected to be effective at the     patient level as well as cost effective with respect to the increasing financial burden of     diabetes on the health system.   "
198305|NCT00444912|"     Participants with non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) will be assigned to one     of 2 arms based on the immunophenotype of their lymphoma.      (A)Participants with CD20(-) lymphoma will undergo mobilization with granulocyte     colony-stimulating factor (G-CSF) and plerixafor.      (B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and     plerixafor. They will receive a weekly dose of rituximab beginning 1 week prior to, and     continuing until 2 weeks after, the first dose of G-CSF.      Participants in both groups will receive G-CSF twice daily for 4 days. In the evening on Day     4, a dose of plerixafor will be administered. Apheresis will be initiated the next morning.     Participants will continue to receive G-CSF twice daily and to receive the evening dose of     plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until     ≥5*10^6 CD34+ cells/kg are collected.      Participants who are transplanted will be monitored for the time to polymorphonuclear     leukocytes (PMN), platelets (PLT), and lymphocyte engraftment. Follow-up assessments will be     done at 100 days, and 6 and 12 months post-transplantation.   "
198306|NCT00444925|"     To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo     for overactive bladder   "
198307|NCT00444938|"     This study is evaluating the potential antidepressive effect of a 4 week treatment protocol     using the H-coil deep TMS device in bipolar depression.   "
198308|NCT00444951|"     This study will be conducted among adolescents in Saudi Arabia who previously received one     dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine.     This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and     W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax®     (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal     antibody responses.   "
198309|NCT00444964|"     The main research question this protocol aims to answer is whether treatment with growth     hormone will impact body composition, quality of life, and energy balance in PWS adults, and     if there is a loss of effects after cessation of treatment for at least 12 months.   "
198310|NCT00444977|"     The purpose of this study is to investigate the efficacy of a case management linkage     intervention designed to increase utilization of oral health care services among HIV+     individuals enrolled in HIV primary care that have not seen a dental provider in the     preceding twelve months.   "
198311|NCT00444990|"     OBJECTIVE:      The objective of this study is to determine if treatment with a flex pad impregnated with     static/permanent magnets that can penetrate over 70 mm may improve the quality of chronic     lumbar pain with reduction of pain scores.      HYPOTHESIS:      The researchers hypothesis that the application of a flex pad active magnetic therapy vs.     sham if utilized daily during waking hours can reduce back pain and/or radicular pain. The     null hypothesis is that treatment of subjects with chronic back pain with exposure to     static/permanent magnetic fields have no measurable effect on chronic back pain scores and     will be equal to the underlying placebo.   "
198312|NCT00445003|"     The purpose of the study is to find out if treatment with an intravitreal injection of     triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused     by panretinal photocoagulation treatment. At the present time, it is not known whether     intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections are     beneficial in preventing vision loss after panretinal photocoagulation (PRP) treatment. It is     possible that one or both of the types of injections will prevent vision loss after PRP     treatment. However, it is not known whether the benefits of the injections will outweigh the     risks. It is possible that because of side effects, the injections may not be as good as     laser alone in treating the diabetic retinopathy.   "
198313|NCT00445016|"     To evaluate the incidence of neurologic complications as a consequence of peripheral regional     anesthesia, all patients receiving peripheral nerve blocks will be evaluated according to a     standardized protocol screening pain, motoric and sensory function recovering to defined     periods, and according to a study protocol defining the items.   "
198314|NCT00445029|"     The current knowledge of the pathophysiology of allergic contact dermatitis is based on the     murine model. In this model, CD8+ T cells are effector cells, and CD4+ T cells regulate the     response by limiting the expansion of CD8+ T cells. The goal of this study is to characterize     the pathophysiology of contact dermatitis, with patients allergic to para-phenylenediamine     (PPD).      We suppose that the CD8+ T cells are the effectors of the allergic contact dermatitis,     although the regulator cells belong to the LT CD4+ population. We will test our hypothesis on     blood samples, and cutaneous biopsies of patients allergic to PPD.   "
198315|NCT00445042|"     The purpose of this study is to determine the safety and toxicity levels of Dose Escalated     Sorafenib in the treatment of patients with renal cancer.   "
198316|NCT00445055|"     In this prospective, randomised, placebo-controlled study, the researchers determined whether     0.625 mg or 2.5 mg of IV droperidol given 30 min before emergence from general anaesthesia     reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in     thyroid surgical female population. Two hundred and forty six female patients receiving     general anaesthesia for thyroid surgery received either droperidol 0.625 mg or droperidol 2.5     mg or placebo before emergence.   "
198324|NCT00445159|"     This study will evaluate UT-15C sustained release tablets in subjects experiencing ischemic     lower limb rest pain related to advanced peripheral arterial disease. Rest pain is one of the     primary management issues of severe arterial occlusive disease and may lead to amputation     when the pain becomes intolerable and unresponsive to narcotic analgesia. Rest pain also     impacts the quality of sleep and mobility with frequent interruptions in sleep and decreased     mobility. Treprostinil sodium (Remodulin®) has been studies in several small open-label     studies and has been shown to be safe as well as an effective agent for ischemic rest pain     when given by subcutaneous or intravenous delivery. However, these forms of administration     have patient convenience limitations, including the need for an infusion device and     associated pain at the site of infusion with subcutaneous delivery. UT-15C may allow patients     suffering from CLI to benefit from the simplicity of an oral dosage form   "
198325|NCT00445172|"     The purpose of this study is to investigate the safety and efficacy of long-term E0302     administration in patients with Amyotrophic Lateral Sclerosis (ALS).   "
198326|NCT00445185|"     The current extension study will assess the persistence of anti-HBs antibodies at Months 12,     24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol     posting deals with the objectives & outcome measures of the extension phase at Months 12, 24     and 36. The objectives & outcome measures of the primary phase are presented in a separate     protocol posting (NCT00291941).   "
198327|NCT00445198|"     The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of     ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose.     (This portion of the study is complete). The Phase 2a portion of the study will evaluate     ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a     preliminary assessment of efficacy.   "
198328|NCT00445211|"     Patients with intra-aortic balloon pumps (catheters placed in the groin connected to a pump     which assists the heart by opening and closing a balloon in the aorta, thereby decreasing the     work of the heart and improving blood flow to the coronary arteries) often receive     intravenous (IV) heparin (a blood thinner) to prevent circulation problems in the leg     (where they are inserted). When intra-aortic balloon pumps were initially developed, the     catheters were larger than the catheters used today. Due to the large size of the catheter     and the material used to make the catheter, it was thought that intravenous heparin would     prevent poor blood flow to the leg that contained the temporary catheter. Intravenous     heparin, however, has never been proven to maintain good blood flow in these patients. The     catheters used with intra-aortic balloon pumps are now smaller in size and made of a material     that is less likely to produce blood clots. It is not clear that heparin is needed with     intra-aortic balloon pumps. Bleeding complications associated with intra-aortic balloon pumps     may be decreased if heparin is not used. In 2004, 99 patients received intra-aortic balloon     pumps in the cardiac catheterization labs at William Beaumont Hospital. These patients     received intravenous heparin and experienced a large number of bleeding complications (27     patients required a blood transfusion). This study will help the investigators to clarify if     heparin should or should not be routinely used in patients with intra-aortic balloon pumps.   "
198329|NCT00445224|"     Patellofemoral pain syndrome (PFPS) is a common knee disorder affecting physically active     people. Despite the growing base of support for the early introduction of hip strengthening     exercises into the rehabilitation of PFPS, there have been few randomized clinical trials     comparing isolated hip to isolated quadriceps strengthening. The purpose of this study is to     determine how different exercises affect pain, strength, muscle activity, and function in     female subjects with patellofemoral pain. The researchers hypothesize that females diagnosed     with PFPS who initially participate in a hip strengthening program will report a greater     perceived level of function, greater strength, less pain, and improved neuromuscular activity     than those who participate in a progressive quadriceps strengthening intervention.   "
198330|NCT00445237|"     This study is evaluating the safety and feasibility of the novel deep TMS H-coil designs in     the treatment of resistant major depression in an open study using two different H-coil     designs.   "
198331|NCT00445250|"     Examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo     cutaneous side effect in patients receiving radiotherapy to the breast.      To check the connection between the skin effect of radiotherapy and different parameters     including diseases such as diabetes and lupus, use of medications, allergies, weight, habits,     size of the irradiated breast, previous chemotherapy treatment and exposure to sunlight.   "
198332|NCT00445263|"     The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main     evolutionary risk of these patients is the coronary thrombosis and its self complications.     The platelets aggregation plays a major role in the physiopathology of the ACS. The     therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has     been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of     these products in the ACS with or without ST elevation, associated or not to coronarography,     has clearly been demonstrated. This profit is more marked when patients are at high risk of     complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at high     risk for whom a coronarography is planned, in the last international recommendations of the     European Cardiology Society (ESC), the American Heart Association and the American College of     Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on     coronarography with discordant results. The ideal delay of realization of this coronarography     is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again,     patients at high risk seem to benefit the more of such a strategy if it is set precociously.      Objective To compare an invasive strategy associating an early administration of tirofiban     and a coronarography achieved in the 6 hours after the randomization to a conservative     strategy in a population of high risk patients with ACS without ST elevation.      Design Multicentric, prospective, randomized study.   "
198333|NCT00445276|"     Pain is the main symptom of osteoarthritis that motivates medical visits. Diacerhein has     already demonstrated its efficacy in knee and/or hip osteoarthritis. This study aims at     confirming the efficacy of diacerhein in symptomatic knee osteoarthritis using known and     validated criteria and according to the recommendations and guidelines for this kind of     study.   "
198334|NCT00445289|"     This bicentric, randomized, controlled trial examines the effectiveness of an automatic     control of pressure support ventilation (SmartCare/PS) in critically ill patients.   "
198335|NCT00445302|"     Eligible male and female subjects with renal impairment (aged 18-78 years) and healthy     control subjects (aged 35 to 78 years) will be enrolled in the study. Subjects with renal     impairment will be enrolled and entered into three groups based on their renal function: Mild     Impairment, Moderate Impairment, and Severe Impairment(not requiring dialysis). Control     subjects will have normal renal function.      The screening visits will occur within 14 days prior to plerixafor administration on study     day one. Subjects will be monitored for 10 hours following administration of the study drug.     In addition, subjects will return to the clinic at 24 and 48 hours after plerixafor     administration for blood samples and safety assessments.   "
198336|NCT00445315|"     Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in     HCV positive patient volunteers   "
198337|NCT00445328|"     The purpose of this study is to compare the efficacy and safety of dalteparin vs     unfractionated heparin for the prevention of VTE (Venous Thromboembolism) in hospitalized     acutely ill medical patients.   "
198338|NCT00445341|"     Background:      Mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLBCL) are aggressive subtypes     of non-Hodgkin lymphoma.      Flavopiridol is an investigational drug that works differently from standard chemotherapy and     may target abnormalities in MCL and DLBCL cells, such as a protein excess that prevents tumor     cells from dying.      A challenge in developing flavopiridol for treatment has been determining its optimal dosing     schedule. The schedule used for this study is effective in a type of leukemia called chronic     lymphocytic leukemia (CLL) and may benefit patients with MCL and DLBCL also.      Objectives:      To determine the highest dose of flavopiridol that can be given safely to patients with     relapsed MCL and DLBCL at the dosing schedule detailed below      To assess the response of the tumor to flavopiridol given at the test dosing schedule      Eligibility:      Patients 18 years of age and older with relapsed MCL or DLBCL      Design:      Flavopiridol is given at four different dose levels, starting with the lowest dose for the     first group of three to six patients and increasing with subsequent groups, depending on side     effects at the preceding dose. The drug is given weekly for 4 weeks followed by a 2-week     break (one cycle) for up to six cycles. It is given through a vein as a 30-minute infusion     followed by a 4-hour infusion.      Patients undergo the following procedures for research studies and to evaluate the effect of     treatment on the tumor:        -  Blood tests        -  Lymph node, bone marrow and tumor biopsies        -  Lymphapheresis to collect blood cells for research        -  Disease staging with imaging studies (computed tomography (CT), positron emission          tomography (PET) and/or magnetic resonance imaging (MRI) after every 2 cycles   "
198339|NCT00445354|"     This study will randomize diabetics with hemoglobin A1c greater than 7.0 to receive either     cinnamon plus usual care or usual care alone. Hemoglobin A1c will be measured at intake and     after 90 days.   "
198340|NCT00445367|"     To establish a large, longitudinal collection of high quality samples and data from subjects     with MS, selected other demyelinating diseases (Transverse Myelitis (TM), Neuromyelitis     Optica (NMO) or Devic's, Acute Disseminated Encephalomyelitis (ADEM), and Optic Neuritis     (ON)), and related and unrelated unaffected controls. Samples and data will be available as a     shared resource to scientists researching the causes, sub-types, and biomarkers of MS and     related demyelinating diseases.   "
198341|NCT00445393|"     The purpose of this pilot study is to determine the presence, frequency, and severity of     mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.   "
198342|NCT00445406|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the     growth of breast cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such     as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab     together with doxorubicin hydrochloride liposome may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab     together with doxorubicin hydrochloride liposome works in treating women with locally     recurrent or metastatic breast cancer.   "
198343|NCT00445419|"     Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic     hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER     platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular     immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a     hepatitis C virus infection. In-depth research in recent years has shown that the cellular     immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV     vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together     with a supportive helper T cell response (PeviPRO). This virosome-based technological     combination in a single product represents a new generation of modular therapeutic vaccines.   "
198344|NCT00445432|"     To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical     remission in Japanese subjects with Crohn's disease.   "
198345|NCT00445445|"     RATIONALE: Studying mammograms for breast density changes over time may help doctors predict     breast cancer risk.      PURPOSE: This natural history study is looking at changes in breast density and gathering     health information over time to assess breast cancer risk in women with breast cancer and in     healthy women.   "
198346|NCT00445458|"     The purpose of this study is to learn whether it is safe and effective to administer HKI-272     (neratinib) in combination with paclitaxel in patients with breast cancer.   "
198455|NCT00437944|"     The rational of the study is to try to predict which of the patients who suffer from Fabry     disease will have End Stage Renal Disease. We hope to find correlation between certain     modifier genes, previously related to renal disease, to renal disease in Fabry.   "
198373|NCT00445848|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop     the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving     erlotinib together with bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab     works in treating patients with stage IIIB or stage IV primary non-small cell lung cancer who     have never smoked.   "
198347|NCT00445471|"     The current study aims at comparing outcomes achieved using the Mifne approach of treating     autistic children with results obtained when routine standard treatment is used. A     prospective comparative study will be performed comparing the results of 12 children treated     at Mifne with 12 children treated with treatment as usual. A child and adolescent     psychiatrist using the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic     Observation Schedule-Generic (ADOS-G) will make the diagnostic assessment and a developmental     psychologist will make the developmental and psychological assessments using the Vineland     Adaptive Behavior Scales-Revised and the Bayley Scales of Infant Development (BSID II) before     the child enters the study. Each child will be reassessed following completion of the Mifne     intervention, at three and at six months after commencement of treatment. The control child     will also be reassessed at three and at six months after commencement of a therapeutic     intervention.   "
198348|NCT00445484|"     RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in     different ways and stop cancer cells from growing. Vaccines may help the body build an     effective immune response to kill cancer cells. Giving lenalidomide together with vaccine     therapy may make a stronger immune response and kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine     therapy works in treating patients with relapsed or refractory multiple myeloma.   "
198349|NCT00445497|"     RATIONALE: Finishing an antibiotic regimen at home may be as effective as receiving it in the     hospital. It is not yet known whether early hospital discharge is as effective as standard     inpatient care in cancer patients receiving antibiotics for febrile neutropenia.      PURPOSE: This randomized phase III trial is studying early hospital discharge and comparing     it with standard inpatient care in cancer patients receiving antibiotics for febrile     neutropenia.   "
198350|NCT00445510|"     This will be a single centre, randomised, double-blind, placebo-controlled, 2-period     crossover study to investigate the effect of treatment with repeat inhaled doses of GSK256066     on bronchial hyper-reactivity to adenosine monophosphate.   "
198351|NCT00445523|"     Patients with metastatic renal cell cancer will be enrolled to receive either Trovax® alone     or Trovax® plus Interferon Alfa. The study will try to determine whether the use of Trovax®     will delay tumor progression.   "
198352|NCT00445549|"     Background:        -  Vandetanib is a drug that attacks a group of proteins on the surface of many cells,          especially blood vessel cells and tumor cells.        -  Tumors require the development of new blood vessels in order to grow and spread.        -  In laboratory experiments, vandetanib slowed the growth of certain tumors and regulated          their blood vessel growth.        -  In early clinical trials, some patients' tumors did not grow for a period of time while          they were receiving vandetanib.      Objectives:        -  To determine whether vandetanib can cause tumors to shrink or stabilize in some patients          with ovarian cancer, fallopian tube cancer or primary peritoneal cancer.        -  To determine, by tumor biopsy, if features of the tumor change with vandetanib treatment          may predict if the tumor will likely respond to vandetanib.      Eligibility:        -  Women 18 years of age and older with ovarian, fallopian tube or primary peritoneal          cancer that does not respond to standard treatment.      Design:        -  Patients take vandetanib daily, by mouth in 28-day cycles until their disease worsens or          they develop unacceptable side effects.        -  Tumor biopsies (surgical removal of a sample of tumor tissue) are done before starting          vandetanib treatment and after 6 weeks of treatment.        -  Patients are followed in the clinic every 4 weeks during treatment for a physical          examination, blood tests, and review of laboratory studies and side effects.        -  Patients have a computed tomography (CT) scan every 8 weeks to monitor tumor growth and          magnetic resonance imaging (MRI) before starting vandetanib treatment, on the third day          after taking vandetanib and 6 weeks into treatment.        -  Patients quality of life is assessed with regularly scheduled questionnaires.   "
198353|NCT00445562|"     RATIONALE: Collecting blood samples and health information from patients with invasive breast     cancer and from their brothers and sisters over time may help the study of cancer in the     future.      PURPOSE: This study is collecting blood samples and health information over time from     patients with invasive breast cancer and from their brothers and sisters.   "
198354|NCT00445575|"     This trial is intended to test the efficacy of an oral bisphosphonate (risedronate) to     decrease bone pain and improve radiological aspect in fibrous dysplasia of bone.   "
198355|NCT00445588|"     This phase II trial is studying how well giving erlotinib together with sorafenib works in     treating patients with progressive or recurrent glioblastoma multiforme. Erlotinib and     sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. Giving erlotinib together with sorafenib may     kill more tumor cells.   "
198356|NCT00445601|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving gemcitabine directly into the bladder after surgery may kill more tumor cells. It is     not yet known whether giving gemcitabine directly into the bladder is more effective than a     placebo in treating bladder cancer.      PURPOSE: This randomized phase III trial is studying gemcitabine to see how well it works     when given directly into the bladder compared with a placebo after surgery in treating     patients with newly diagnosed or recurrent bladder cancer.   "
198473|NCT00438178|"     Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow     unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis     through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process     of cell death that is often inhibited in cancer cells.   "
198357|NCT00445614|"     Fish from the aquaculture sector constitutes an increasing part of the fish consumption in     Denmark. The most important farmed fish in Denmark is the rainbow trout. Due to limited     access of wild fish for the feed production, alternative feeding regimes of vegetable origin     such as vegetable proteins and rapeseed oil are used instead of marine feed. This change in     feeding regime may affect flesh quality and health and nutritional properties as the content     of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) will presumably decrease in the     meat. The objective of the study is to investigate the effect of vegetable based feed versus     marine feed of farmed trout and its effect in healthy men on cardiovascular risk markers     associated with the development of cardiovascular disease (CVD).   "
198503|NCT00438581|"     This aim of this study to evaluate the safety and efficacy of combining a single course of     Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with     high-dose BEAM chemotherapy and autologous peripheral stem cell transplantation in patients     with relapsed, refractory, or transformed Non-Hodgkin's lymphoma.   "
198358|NCT00445627|"     This study will determine whether resting beta cells (cells in the pancreas that produce     insulin) for 2 weeks will improve the ability of patients with Type 2 diabetes mellitus     (T2DM) to make insulin. Beta cells can rest by giving patients insulin shots. The study will     also examine how teenagers with T2DM feel about having diabetes and explore differences     between young people with and without T2DM.      This study includes patients 12 to 25 years of age with T2DM who are overweight and who were     diagnosed within 2 years of enrolling in the study. Healthy individuals of normal weight or     who are overweight are also eligible. Candidates are screened with a medical history,     physical examination and laboratory tests.      Participants with T2DM are assigned to one of two groups. Group 1 takes an anti-diabetes     medicine called metformin and follows a diet prescribed by a study staff dietitian for 2     weeks. Group 2 takes metformin, follows the prescribed diet, and receives insulin through a     pump under the skin for 2 weeks. During these two weeks, all participants have the following     tests:        -  Frequent blood sugar checks.        -  Oral glucose tolerance test (routine diabetes test in which blood samples are drawn          before and several times after the subject drinks a sugary solution).        -  Arginine stimulation to test the response of the body to arginine, a normal ingredient          of food that stimulates the release of insulin. Two catheters are placed into veins in          the arms, one to administer a liquid containing arginine, the other to draw the blood          samples.        -  Ultrasound of the blood vessels in the neck to check for hardening of the arteries.        -  Metabolism test to measure the amount of oxygen used during rest. The subject breathes          normally during rest while wearing a canopy over his or her head for about 20 minutes.        -  MRI scans of the abdomen to examine the amount of fat in the belly (at the beginning and          end of the study)        -  DEXA scan to determine percent body fat.        -  Tests to explore quality of life and feelings about health, work or school, friends and          family.        -  Exercise testing on a treadmill or stationary bicycle.        -  Genetic studies for information on diabetes and obesity.      Normal volunteers have blood draws, oral glucose tolerance testing, MRI scan, DEXA scan,     psychological testing, exercise testing, and genetic testing.   "
198359|NCT00445653|"     RATIONALE: A study that evaluates DNA changes and other disease-related health information in     patients with Barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding may     help doctors learn more about the risk factors for Barrett's esophagus.      PURPOSE: This clinical trial is looking at DNA changes and other disease-related health     information as risk factors for Barrett's esophagus in patients with Barrett's esophagus,     gastroesophageal reflux, or gastrointestinal bleeding.   "
198360|NCT00445679|"     This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate     sustained release (DVS SR) in subjects with major depressive disorder.   "
198361|NCT00445692|"     This phase II trial studies lenalidomide, dexamethasone, and clarithromycin in treating     patients who have undergone stem cell transplant for multiple myeloma. Biological therapies,     such as lenalidomide and clarithromycin, may stimulate the immune system in different ways     and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving lenalidomide together with dexamethasone and     clarithromycin may be an effective treatment for multiple myeloma.   "
198362|NCT00445705|"     This study will explore the safety and effectiveness of different doses of AGN 203818 in     treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2     parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over     4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg     BID AGN 203818 or placebo over 12 week treatment duration.   "
198363|NCT00445718|"     This natural history study is collecting health information about infants with adrenal masses     found on prenatal and/or neonatal imaging. Gathering information over time from imaging and     laboratory tests of infants with adrenal masses may help doctors learn more about the disease     and plan the best treatment.   "
198364|NCT00445731|"     RATIONALE: A walking program may improve the ability to carry out daily activities after     donor bone marrow transplant.      PURPOSE: This randomized clinical trial is studying a structured walking program to see how     well it works compared with standard therapy in cancer patients undergoing a donor bone     marrow transplant.   "
198365|NCT00445744|"     This trial is studying the side effects and how well giving cyclophosphamide and busulfan     followed by donor stem cell transplant works in treating patients with myelofibrosis, acute     myeloid leukemia, or myelodysplastic syndrome. Giving chemotherapy, such as cyclophosphamide     and busulfan, before a donor stem cell transplant helps stops the growth of cancer cells. It     also helps stop the patient's immune system from rejecting the donor's stem cells. The     donated stem cells may replace the patient's immune cells and help destroy any remaining     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can     also make an immune response against the body's normal cells. Giving tacrolimus and     methotrexate after the transplant may stop this from happening   "
198366|NCT00445757|"     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor     and cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery     may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic     radiation therapy in treating patients with kidney tumors.   "
198367|NCT00445770|"     The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared     with methotrexate (up to 8 mg per week) on the slowing of joint destruction.   "
198368|NCT00445783|"     RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may     help doctors understand the risk factors for melanoma relapse.      PURPOSE: This clinical trial is studying the risk factors for melanoma in families with     melanoma.   "
198369|NCT00445796|"     Primary Objective:      To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day     14, of administration of Arsucam® as a single daily intake versus two daily intakes.      Secondary Objective:      To compare the clinical safety of the two treatment regimens.   "
198370|NCT00445809|"     Some patients who undergo cardiovascular surgery requiring cardiopulmonary bypass will     develop a kidney injury following their surgery. The purpose of this study is to take a blood     sample from patients before they have this type of surgery and then at nine time points after     their surgery to test their plasma for a biomarker called NGAL and compare the NGAL levels to     their creatinine levels. We hypothesize that NGAL is an earlier marker for kidney injury than     creatinine.   "
198371|NCT00445822|"     Newly diagnosed pediatric patients (age < 19 years) with bcr-abl-positive CML will be treated     with imatinib. Serial monitoring of treatment response is performed in one month intervals     during the first three months of treatment and in three months intervals thereafter. Patients     with non-response, poor response (either molecular, cytogenetic, or hematologic non-/poor     response) or progress of the disease while under imatinib treatment will stop imatinib and     undergo stem cell transplantation. All responders to imatinib treatment with an HLA matched     donor will undergo stem cell transplantation not later than 2 years after diagnosis.   "
198374|NCT00445861|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving cetuximab, docetaxel, and cisplatin together with     radiation therapy before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed.      PURPOSE: This phase I/II trial is studying the side effects of cetuximab, docetaxel,     cisplatin, and radiation therapy and to see how well they work in treating patients with     locally advanced esophageal cancer that can be removed by surgery.   "
198375|NCT00445874|"     The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with     a contact lens compared to placebo in preventing ocular itching associated with allergic     conjunctivitis   "
198376|NCT00445887|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of levonorgestrel may prevent ovarian cancer.      PURPOSE: This randomized phase II trial is studying how well levonorgestrel works in     preventing ovarian cancer in patients at high risk for ovarian cancer.   "
198377|NCT00445900|"     RATIONALE: Giving thalidomide together with prednisone and cyclophosphamide may lessen     symptoms caused by myelofibrosis and myeloid metaplasia.      PURPOSE: This phase II trial is studying the side effects and how well giving thalidomide     together with prednisone and cyclophosphamide works in treating patients with myelofibrosis     and myeloid metaplasia.   "
198378|NCT00445913|"     The proposed studies describe a randomized trial to evaluate the safety of a new     diabetes-suppressive cell vaccine, consisting of autologous monocyte-derived dendritic cells     treated ex vivo with antisense phosphorothioate-modified oligonucleotides targeting the     primary transcripts of the CD40, CD80 and CD86 co-stimulatory molecules (immunoregulatory DC;     iDC). The hypothesis to be tested in this study is that iDC are safe and without toxicity in     established type 1 diabetic patients.      Fifteen (15) individuals exhibiting fully-established, insulin-dependent type 1 diabetics,     without any diabetes-related complications, infectious disease, or other medical anomaly,     will be enrolled to establish safety of the approach. 7/15 volunteers will be administered     autologous control dendritic cells and 8/15 will be administered iDC. The study is     anticipated to be complete by twelve (12) months.      Currently, other than a humanized anti-CD3 antibody with considerable side effects, there is     no other means to reverse new-onset type 1 diabetes. These studies will be the first ever to     employ autologous dendritic cell transfer to suppress an autoimmune disease and to perhaps     reverse it early on in the clinical process.   "
198379|NCT00445926|"     The study evaluates the feasibility of using a 4 week stimulation protocol with the deep TMS     H-coils for the treatment of negative symptoms and cognitive deficit in schizophrenia     patients   "
198380|NCT00445939|"     The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the     induction of clinical remission in Japanese subjects with Crohn's disease.   "
198381|NCT00445952|"     RATIONALE: Gathering information about how often fungal infections of the blood occur in     patients with cancer or in patients who have undergone stem cell transplant may help doctors     learn more about the disease.      PURPOSE: This natural history study is collecting information about fungal infections of the     blood over time from patients with cancer or from patients who have undergone a stem cell     transplant.   "
198382|NCT00445965|"     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8,     can find tumor cells and carry tumor-killing substances to them without harming normal cells.     This may be an effective treatment for central nervous system cancer or leptomeningeal     metastases.      PURPOSE: This phase II trial is studying the side effects and how well iodine I 131     monoclonal antibody 3F8 works in treating patients with central nervous system cancer or     leptomeningeal cancer.   "
198383|NCT00445978|"     This Phase 2a, multicenter, open-label, dose-escalation study is designed to assess the     safety and biologic activity of daily oral administration of 4 escalating doses of 6R-BH4     over 16 weeks in subjects with sickle cell disease. During an optional extension phase, the     study will assess the safety, tolerability, and efficacy of extended treatment with 6R-BH4,     for a total of up to 2 years.   "
198384|NCT00446004|"     This is a research study that will investigate the effects of proton pump inhibitors (often     used to treat stomach upset) on Gleevec® (a drug that is FDA-approved to treat some types of     cancer) in healthy volunteers. Twelve healthy volunteers (six men and six women) will be     recruited to complete the study. This research study will compare Gleevec® in the body when     taken with and without proton pump inhibitors (PPI). Each volunteer will receive a 400 mg     pill of Gleevec® on two occasions. On one occasion they will take the dose of Gleevec® alone     (without PPI). On another occasion, they will take the Gleevec® after taking 40 mg of PPI     daily by mouth for six days. Several blood samples will be drawn to measure the     concentrations of Gleevec® and its breakdown products in the blood, with and without the     influence of PPI.   "
198684|NCT00449280|"     The goal of this study is to determine whether a significant pharmacokinetic interaction     exists between rapamycin and sorafenib.      This study will also look at the toxicity of the combination of rapamycin and sorafenib and     the antitumor activity of the combination in subjects with advanced cancers.   "
198385|NCT00446017|"     Myocardial dysfunction necessitating inotropic support is a typical complication after     on-pump cardiac surgery. This prospective, randomized pilot-study analyses the metabolic and     renal effects of the inotropes adrenaline and milrinone in patients needing inotropic support     after coronary-artery-bypass-grafting. With respect to data derived from patients with sepsis     shock and results from studies using phosphodiesterase-inhibitors prophylactically, the     hypothesis is tested that adrenaline may be associated with unwarranted metabolic effects     (hyperlactatemia and hyperglycemia) and renal dysfunction.   "
198386|NCT00446030|"     This is a phase II, open-label, multicenter, pilot study of the safety and efficacy of two     Docetaxel-based regimens plus bevacizumab for the adjuvant treatment of participants with     node positive or high risk node negative breast cancer.      The primary objective of this study was to evaluate the cardiac safety, and the secondary     objectives were to evaluate safety and toxicity of participants treated with bevacizumab ±     trastuzumab administered with 2 different docetaxel-based combination regimens.      This study was originally designed to also evaluate disease-free survival (DFS) and overall     survival (OS); however, based on a protocol amendment, follow-up was shortened from 10 years     to 2 years, and the efficacy endpoints of disease free survival and overall survival were     deleted from the protocol.   "
198387|NCT00446043|"     This is a multi-centre, open-label, non-comparative study to evaluate the long-term safety     and efficacy profile of Adapalene/Benzoyl Peroxide Gel.      Subjects are evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.      Safety is evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability     Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing     (haematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations.     Efficacy is evaluated by analysis of Percent Change from Baseline in Inflammatory,     Noninflammatory, and Total Lesion Counts, and by the Subject’s Assessment of Acne.   "
198388|NCT00446056|"     The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen,     used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over     first 2 weeks in patients with pediatric bronchial asthma aged 6 to < 15.      The effect of body weight on the efficacy and safety of montelukast will also be evaluated in     this study.   "
198389|NCT00446069|"     The purpose of the study is to determine the effect of Egalet® Morphine once daily compared     to MST Continus twice daily on pain intensity and use of rescue medication for break through     pain after 2 weeks of treatment in patients with pain due to cancer.   "
198390|NCT00446082|"     This study will assess the pharmacokinetic profile and the safety/tolerability profile of     single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with     acromegaly and patients with carcinoid disease   "
198391|NCT00446095|"     Patients: B-cell lymphoma, refractory, diffuse, nodular, mantle, other Phase I : Two groups     of 6 patients, escalating dose tolerability- 28 days Phase II: Three groups of 16 patients     (nodular, diffuse large cell, mantle cell plus others). Oral bid dosing with highest     tolerable dose until toxicity, progression, or withdrawal   "
198392|NCT00446108|"     This is a retrospective chart review examining children and adults with history of Tetralogy     of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement.     The primary interest of the study is to analyze the routine pre- and post-operative imaging     studies.   "
198393|NCT00446121|"     The main purpose of the study is to evaluate the effect of mannitol on the cilia's beat     frequency (ciliary beat frequency) in COPD patients.   "
198394|NCT00446134|"     The objective of the study is to select an optimal dose of taribavirin by comparing the     efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin     800 to 1400 mg/day based on body weight, both administered in combination with peginterferon     alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.   "
198395|NCT00446147|"     Although pyridoxine has been used empirically for the prevention of capecitabine associated     hand-foot syndrome (HFS), its efficacy needs to be demonstrated in prospective controlled     trials. The investigators therefore performed a prospective randomized double-blind study to     determine whether pyridoxine 200 mg/day can prevent the development of HFS when given     concurrently with capecitabine. The investigators also tested the ability of pyridoxine to     treat primary occurrence of grade 2-3 HFS.   "
198396|NCT00446160|"     It is now estimated that the number of adults with congenital heart disease in the U.S is     over 800,000. Unfortunately, these patients, in some way, have become a lost population. They     have congenital abnormalities familiar to a children's hospital, yet have surpassed the age     cutoff for admission.      Recently, we have developed a specialized program to care for this unique patient population.     Dedicated programs such as ours hope to optimize patient care, consolidate specialized     resources, provide sufficient patient numbers for training and maintain expertise and     facilitate research in this unique population.   "
198397|NCT00446173|"     Primary Objective:      1. To study ex-vivo purging of autologous hematopoietic stem cells that will be used to     support high-dose chemotherapy in patients with chronic myelogenous leukemia (CML). Major     endpoints are neutrophil engraftment and survival.      Secondary Objectives:        1. To evaluate the toxicity of ex-vivo purged autologous cells when used to support          high-dose chemotherapy.        2. To evaluate the rate and duration of cytogenetic remissions achieved with this strategy.        3. To determine the time to platelet recovery to 20,000/mm3.        4. To determine the one-year survival rate.   "
198398|NCT00446186|"     The clinical study evaluates the efficacy and safety of MK0476 in adult patients with     allergic rhinitis.   "
198399|NCT00446199|"     The purpose of this study is to determine the lowest effective dose of the study drug for the     relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.   "
198400|NCT00446212|"     We hypothesise that patients who receive propofol for maintenance of anaesthesia will report     dreaming more often when they emerge from anaesthesia than patients who receive desflurane     for maintenance of anaesthesia.   "
198401|NCT00446225|"     A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus     chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK)     domain of the EGFR.   "
198402|NCT00446238|"     The purpose of this study is a randomized trial of cognitive-behavioral intervention (CBI)     for eligible adolescents who have Inflammatory Bowel Disease and subsyndromal depressive     symptoms, but who did not meet diagnostic criteria for major depressive disorder at the time     of randomization into the study.      Hypotheses        1. This preliminary randomized trial will demonstrate the feasibility of a large-scale          research initiative.        2. Subjects will experience no adverse events, and the CBI group will demonstrate improved          negative cognitions, depressive symptomatology, and functioning at the post-intervention          and 6- through 12-month follow-ups.   "
198403|NCT00446251|"     This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab     with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just     completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment     and at 6 and 12 months on combined therapy as well as the rates of transplant will be     compared and evaluated using descriptive analysis.   "
198419|NCT00446459|"     This is a 12-month, phase II, prospective, open label study, to evaluate the effect of     mycophenolate mofetil (MMF) among patients on the kidney transplant list with high Panel of     Reactive Antibody (PRA) levels.      On average, increasing the PRA from 0 to 50% specifically in the Washington Organ Procurement     Organization (OPO) increases the waiting time from 3 to 6 years. Spontaneous decreases in the     PRA rarely occur and is associated with a decreased chance for transplantation and a     decreased rate of survival.   "
198404|NCT00446264|"     The restoration of endogenous insulin secretion carries significant hopes for shifting the     paradigm of life long exogenous insulin therapy in selected groups of patients with type 1     diabetes(T1D). After decades of frustrating clinical attempts, the Edmonton group set up in     2000 new standards for islet transplantation in patients with brittle T1D by achieving     insulin independence in 80 percent of patients. These seminal results have however proved     much more difficult to duplicate than initially expected.      This single center phase 2 clinical trial, duplicating the Edmonton protocol, is designed for     confirming the consistent short term efficacy and safety of sequential islet     allotransplantation with steroid free immunosuppression in patients with severe T1D.   "
198405|NCT00446277|"     The aim of the present study is to evaluate changes in the morphology and function of the     corneal endothelium before and after cataract surgery in patients with diabetes type II. Also     to explain if determination of HgbA1c in diabetics is a predictor for the changes in     morphology and function.   "
198406|NCT00446290|"     Considering synergism between docetaxel (D), capecitabine (X), and oxaliplatin (O) and     favourable toxicity profile of oxaliplatin over cisplatin, it is to be expected that     combination of docetaxel, capecitabine, and oxaliplatin (DXO) will be more effective than     other regimens and feasible in advanced gastric cancer. DXO regimen can be also easily     administered on out-patient setting. However, so far, DXO combination has not been tried in     advanced gastric cancer. The investigators will determine maximum tolerated dose of DXO     regimen in this phase I study.   "
198407|NCT00446303|"     A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving     complete or partial remission (CR or PR) after intensive chemoterapy.      The primary objective is response duration (MDS or AML)   "
198408|NCT00446316|"     This is a research study that will investigate the effects of antacids (often used to treat     stomach upset) on Gleevec® (a drug that is FDA-approved to treat some types of cancer) in     healthy volunteers. Twelve healthy volunteers (six men and six women) will be recruited to     complete the study. This research study will compare Gleevec® in the body when taken with and     without antacids. Each volunteer will receive a 400 mg pill of Gleevec® on two occasions. One     one occasion they will take the dose of Gleevec® alone. On another occasion, they will take     the Gleevec® 15 minutes after taking a 20 mL dose of antacids. Several blood samples will be     drawn to measure the concentrations of Gleevec® and its breakdown products in the blood, with     and without the influence of antacids.   "
198409|NCT00446329|"     The 1st phase of the study will assess the acute biochemical response of PTH, calcium and     phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per     day.      The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD     (bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to     control secondary hyperparathyroidism without simultaneous administration of other vitamin D     compounds.   "
198410|NCT00446342|"     The purpose of this study is to assess the safety and tolerability of escalating doses of     SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2     dose.   "
198411|NCT00446355|"     The purpose of the study is to establish the clinical disease outcomes and features of CDAD     associated with variant tcdC genotypes. Two hypotheses are to be tested in this study:        1. Severe CDAD and tcdC truncation:           Severe CDAD (defined by death and/or colectomy or secondary endpoints) is associated          with severe truncations (> 6 amino acid residues) in TcdC, a negative regulator of toxin          A/B production.        2. Disease in low risk populations (patients never exposed to health care facilities and/or          patients who never received antibiotics) of any severity is attributable to strains of          C. difficile with severe tcdC truncation.   "
198412|NCT00446368|"     Patients with metastatic renal cell cancer will be enrolled to receive RAD001 to determine     whether the use of RAD001 will result in an improvement in the time to tumor progression.   "
198413|NCT00446381|"     Patients with proliferative diabetic retinopathy or clinically significant diabetic macular     edema requiring surgical intervention will receive a pre-operative injection of Macugen. An     initial, pre-injection vitreous tap will be done in order to provide baseline VRGF 165 and     cytokine levels. At the onset of the vitrectomy, a second vitreous sample will be taken to     obtain intra-operative levels of Macugen, VEGF 165 and cytokines.   "
198414|NCT00446394|"     The purpose of this project is to evaluate an exercise and health promotion program for older     adults with mild memory loss. The study will investigate the efficacy of a memory-enhanced     exercise and health promotion program to determine whether it is more effective than a social     walking program in delaying further memory decline, improving mood and physical function, and     enhancing quality of life.   "
198685|NCT00449293|"     The objective of this pilot research is to investigate the effects of two behavioral smoking     cessation programs on aspects of cue-induced cigarette craving, and to further investigate     the neural bases of such effects.   "
198415|NCT00446407|"     Depressive and anxiety disorders (termed as 'Common Mental Disorders') affect as many as one     in four persons attending primary care; most patients do not receive effective treatments.     Although the integration of mental health in primary care is accepted as the only feasible     way of managing Common Mental Disorders in developing countries, there is no evidence     demonstrating how this can be done in a manner which is effective and affordable. The     hypothesis of this trial is that a Collaborative Stepped Care package will be both clinically     and cost-effective for the treatment of Common Mental Disorders in primary care.   "
198416|NCT00446420|"     Our hypothesis is that adding midazolam and/or fentanyl to propofol sedation for elective     outpatient colonoscopy increases cognitive impairment at hospital discharge without improving     intraoperative conditions or reducing intraoperative side-effects.      200 healthy patients aged 18 years or older will be randomised to receive propofol or     propofol plus midazolam and/or fentanyl. Cognitive impairment will be tested at hospital     discharge using Cogstate computerised testing software.   "
198417|NCT00446433|"     A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate     the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults with Moderately     Severe Crohn's Disease   "
198418|NCT00446446|"     To estimate the effect of second-line panitumumab monotherapy on objective response in     patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).   "
198420|NCT00446472|"     The objective of this study is to compare the effectiveness and safety of windowed casts with     Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment of     diabetic ulcers on the legs and feet.   "
198425|NCT00446537|"     Skill acquisition refers to the process of improvement of performance following practice     experience. This process is the basis for generation of a long-lasting memory. Individuals     with Attention Deficit Hyperactivity Disorder (ADHD) have been shown to be impaired on some     performance aspects of previously learned skills, an impairment that is often ameliorated, at     least temporarily, by psychostimulant medication (the standard therapy in ADHD). The proposed     study aims to define the course of learning and of generation of long-term memory     consolidation in individuals with ADHD, and to essay the effectiveness of psychostimulant     medication on both the learning and retention of the skills.   "
198426|NCT00446550|"     This study is being conducted to evaluate the safety and effects of AT2101 in patients with     type I Gaucher disease who are not receiving ERT or SRT.   "
198427|NCT00446563|"     This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients     with hypertension and left ventricular hypertrophy   "
198428|NCT00446576|"     The purpose of this study is to assess whether maintaining hemoglobin (Hb) levels at normal     or sub-normal levels with Epoetin Alfa can influence the health status, left ventricular mass     and quality of life of early renal insufficiency subjects without additional safety concerns.   "
198429|NCT00446589|"     Hemodialysis patients with low bone density (total hip T-score <-2.5) will be assigned to     receive teriparatide (those with histologic confirmation of adynamic bone disease) or     ibandronate (subjects with increased osteoclast number on bone biopsy).      Follow-up period: one year. A second bone biopsy at the end of the study.   "
198430|NCT00446602|"     The purpose of this study is to evaluate the effectiveness of PROCRIT (Epoetin alfa) 80,000     Units given once weekly or 80,000 Units given once every two weeks in anemic patients with     Low- or Intermediate-1 risk Myelodysplastic Syndromes (MDS).   "
198431|NCT00446615|"     In 2001, an estimated 1.9 million Canadians had chronic renal disease and the number of     patients being treated for end stage renal disease climbed by nearly 20% in 5 years. Many     medications commonly used in elderly patients are excreted by the kidney. Failure to adjust     doses in those with impaired renal function can result in medication overdose, leading to     potentially serious morbidity and mortality. Studies in hospitals and long term care     facilities have found a 19-67% rate of non-compliance with guidelines for medication dose     adjustment in patients with renal insufficiency and in ambulatory care one study found a 69%     rate of non-compliance. Since primary care physicians write 80% of prescriptions for those     aged 65 years, there is a need for interventions to improve prescribing to patients with     renal impairment in primary care.      This study will develop an audit tool and electronic decision support tool that will be     incorporated into the electronic medical record in a large academic family health centre. It     is seen as a preliminary step in a project to assess the effectiveness of a multifaceted     intervention including chart audit, personalized feedback to prescribers, a     pharmacist-facilitated group learning session and the use of an electronic decision support     tool incorporated into the electronic medical record.   "
198432|NCT00446628|"     The purpose of this study is to understand the spread of influenza (flu) in schools and     households with elementary (K-5) school children, and develop ways to reduce the flu using     non-pharmaceutical means.   "
198433|NCT00446641|"     This study will recruit 316 ischemic stroke patients taking aspirin.      They will be randomly assigned into cilostazol group or placebo group. Every patients will     take 200mg of cilostazol a day or placebo for 1 month.      The primary outcome variable of this study is rate of biochemical aspirin resistance on the     Ultra Rapid Platelet Function Assay-ASA.   "
198434|NCT00446654|"     The purpose of this research study is to determine how safe and effective subconjunctival     injections of CGC-11047 are in subjects with wet age related macular degeneration at two     different dosing intervals.   "
198435|NCT00446667|"     COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions,     and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids     for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory     failure. However, associated mucus hypersecretion is responsible for much of the inflammation     and infection. The use of pharmaceutical agents to assist in the early clearance of the     retained mucus has been limited, primarily because of lack of demonstrated effect. There has     been a recent development of interest in pursuing new therapies for improving mucociliary     clearance and several studies have demonstrated that clinical outcomes can be improved when     osmotic agents such as mannitol are added to standard treatments. The purpose of this study     is to conduct a pilot safety study in patients with an acute exacerbation of COPD to     determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.   "
198436|NCT00446680|"     The purpose of this study is to determine the efficacy and safety of chronic treatment with     inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have     demonstrated an improvement in lung function related to small airways obstruction and a     significant improvement in respiratory symptoms and quality of life after a 2 week treatment     with mannitol. This current study seeks to support these early findings and to extend the     evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the     hypothesis that enhanced mucus clearance will improve the lung function and clinical     presentation in this population, will be investigated. We also hypothesize that enhanced     mucociliary clearance will result in a sustained reduction in mucus load, thus providing less     opportunity for bacteria to proliferate, affording a reduction in antibiotic use and     hospitalizations. The initial 6 month blinded phase will be followed with an additional 6     months of open label treatment.   "
198437|NCT00446693|"     The purpose of this study is to clinically assess the safety and performance of the EndoFast     Reliant™ system as a less invasive treatment for Pelvic Organ Prolapse.   "
198501|NCT00438555|"     Randomized, controlled, open, comparative intervention study in 270 children at risk for     obesity.Patients will be randomly allocated into one of two behavior intervention groups or     control group in ratio of 1:1:1.The study will consist of two main periods: an intervention     period of 3 months followed by 21 months of a follow up period. During the intervention     period, participants (parents or both parents and children, depending on randomization) will     attend a behavior intervention program once a week, each session will last one hour and would     be guided by dietician and psychologist. Follow up visits will be performed at the clinic     (for participants in al 3 groups) at months 0, 3, 12 and 24.   "
198438|NCT00446706|"     ARDS (Acute Respiratory Distress Syndrome) is a condition of severe inflammation and excess     fluids in the lungs that impairs their function of oxygen uptake to the point of needing a     ventilator (breathing machine) to help them obtain enough oxygen into the body. Because of     the high amounts of gas that the ventilator has to give to these patients, high pressures may     develop deep into the lungs and produce complications for the patient. However, physicians     sometimes cannot recognize it because it requires special equipment to measure pressure deep     in the lungs. The goal of this study is to determine if the amount of this pressure can be     calculated using mathematical formulas and the routine numbers provided by ventilators. The     study consists on making the conventional measurement of this deep pressure and at the same     time calculate this same pressure from other measurements that the ventilator routinely     provides, to see if the calculated value can replace the more complicated conventional     measurement. The measurements will be done by:        1. placing a small device along the tubing connecting the patient to the ventilator;        2. giving medicines to relax the muscles (if the patient is not already receiving them);          and        3. making the ventilator hold the patient's breath for a few seconds to take measurements.      This is repeated after the breathing rate of the ventilator is increased or decreased mildly.     Risks related to the medicine to be used and the measuring maneuvers are rare but include     transient narrowing of windpipes, transiently low heart rate, blood pressure or blood oxygen,     and allergic reactions. This is not a treatment. The information obtained during the study     will be shared with the treating doctors who may find it useful to make adjustments to the     ventilator. The patient may receive no direct benefit from being in this study; however, the     findings may contribute to better care for this kind of patients in the future.   "
198439|NCT00446719|"     The investigators hypothesize that Rellidep will be effective in improving the symptoms of     major depression. The available evidence strongly suggests that Rellidep contains a mood     altering ingredient or ingredients. This open-label, non-randomized study sets out to     validate its potential antidepressant activity.The study will include secondary aims of     evaluating the effect of Rellidep on reducing symptoms of anxiety, a common symptom     associated symptom of depression and improving quality of life.      About twenty-five patients with major depressive disorder will be assigned to open-label     Rellidep (2000 mg/day) for a period of 8 weeks. All patients will be assessed by various     measures of global improvement, depression, quality of life, sexual experience, anxiety and     measures of side effects as well as standard laboratory tests.   "
198440|NCT00446732|"     According to the Israeli Ministry of Health requirement, this study was designed to evaluate     the efficacy of the UroShield system is patients that require urinary catheterization. This     was designed to compare standard treatment (urinary catheter alone) with the UroShield     treatment in occurrence of catheter associated Urinary Tract infection, pain, discomfort,     Biofilm prevention and trauma.   "
198441|NCT00446745|"     Numerous studies have demonstrated that excess perivisceral adipose tissue is associated with     metabolic diseases such as insulin resistance.      In skeletal muscle, insulin resistance has been correlated with reduced mitochondrial     oxidative functions. According to the actual theory, mitochondrial dysfunctions are proposed     to play a causal role in the aetiology of insulin resistance. Mechanisms involve increased     intramyocellular lipids storage. Yet, the causes responsible for the decline in muscle     mitochondrial functions remain to be elucidated.      The investigators hypothesize that these alterations are induced by combined changes in     plasma profiles of lipids and adipokines, which originate from perivisceral adipose tissue.     The study aims at answering the following questions :        -  Are muscle mitochondrial functions altered in association with increased perivisceral          adipose tissue storage?        -  Do changes in the pattern of plasma lipids and adipokines explain this correlation?   "
198442|NCT00446758|"     To examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool     children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and     improves growth.   "
198443|NCT00446771|"     The study has an open-label, randomized, crossover design, in which each subject will receive     mannitol powder for inhalation using a dry powder inhaler with and without premedication with     a bronchodilator, mannitol powder for inhalation in capsules administered orally, and     mannitol in a commercial formulation designed for intravenous use.   "
198444|NCT00446784|"     CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this     study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in     subjects with rheumatoid arthritis already receiving methotrexate   "
198445|NCT00446797|"     To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day     (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.   "
198456|NCT00437957|"     This type of study is called a Phase I study. Its purpose is to determine the side effects     of the two medicines listed in this study when given together with whole brain radiation, and     the highest dose of valproic acid that can be given together with temozolomide and whole     brain radiation. We will also study the drug combination's effectiveness in treating cancer.     While both of these drugs and whole brain radiation have been used in people for many years,     they have never been combined for the purpose of treating patients with cancer.   "
198446|NCT00446810|"     An AGE-rich diet can induce after 2-6 weeks persistent increases in mediators linked to     vascular dysfunction (e.g. TNFα, VCAM-1) in people with type 2 diabetes mellitus (T2DM).     Benfotiamine (BT), the liposoluble derivative of vitamin B1, blocks several pathways common     to hyperglycaemia- and AGE-induced endothelial dysfunction. We have shown that advanced     glycation end products (AGE) of a regular mixed meal can acutely induce vascular dysfunction     in T2DM and that this effects can be prevented by a three days pretreatment with BT.      The hypotheses of this study are that chronical treatment with benfotiamine (900 mg/day for 6     weeks) in people with type 2 diabetes mellitus:        1. prevents postprandial impairment of endothelial function after a high-AGE meal.        2. Improves fasting endothelial function.        3. Improves parameters of autonomic function in fasting and postprandial state.        4. Improves insulin sensitivity and prevents postprandial increase in insulin resistance.   "
198447|NCT00446823|"     This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for     its ability to naturally (autolytically) remove nonviable tissue and create a healthy     vascular wound bed. Results will compare venous ulcers treated with Xylos XCell cellulose     dressing plus standard care to those treated with standard care alone. The hypothesis is that     XCell will demonstrate more autolytic debridement than the standard of care.   "
198448|NCT00446836|"     The purpose of this study is to determine whether Xyotax, a conjugate of the taxane drug     paclitaxel, is effective in the treatment of prostate cancer that is no longer responsive to     hormone therapy.   "
198475|NCT00438204|"     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium and     gemcitabine together with bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and gemcitabine     together with bevacizumab works in treating patients with stage IIIB or stage IV non-small     cell lung cancer.   "
198449|NCT00437866|"     Background: Anemia in chronic heart failure (CHF) is directly linked to increased mortality     and reduced exercise capacity. The pathomechanism for the development of anemia in CHF is not     well understood. Impairment of iron homeostasis is discussed to be one of the major triggers     in anemia of chronic disease. Hepcidin was recently described as the central regulator of     iron homeostasis.      Main hypothesis: Plasma hepcidin levels are altered in anemic CHF patients compared to non     anemic controls and might be a main contributing factor of anemia in CHF.      Iron regulator-hypothesis High levels of cytokines in CHF patients cause up-regulation of     hepcidin, which in turn leads to low iron uptake causing anemia. In this case venous hepcidin     and hemoglobin concentrations should both correlate with cytokine levels.      Erythropoietin regulator-hypothesis Dysregulation of the erythropoietin system results in     anemia, which represses hepcidin. This leads to a negative correlation between hemoglobin and     hepcidin in plasma.      Methods: 100 consecutive patients diagnosed with systolic CHF will be prospectively included     in the study. Iron status will be assessed and hepcidin, erythropoietin as well as     interleukin-1, interleukin-6 and soluble TNF alpha receptor levels will be measured by ELISA.      Patients will be followed up for one year and mortality, rehospitalization and worsening of     CHF will be documented.   "
198450|NCT00437879|"     We have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently     conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro,     in situ and in vivo. The method can detect different forms of cell death and has been     demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. The objectives of     this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive     marker of advanced tumour response to combined chemotherapy and radiotherapy. Since     neoadjuvant treatments may also act on tumour vasculature to normalize it we will also     evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution     imaging using clinically approved microbubble contrast agents.      The main goal, as described above, is to select the best ultrasound spectroscopy parameter to     use as an early predictor of pathological complete response.   "
198451|NCT00437892|"     Elevated levels of D-dimer, a marker of procoagulant state, have been identified as a marker     of an increased risk of recurrent VTE. Statins have proven antithrombotic properties, as     suggested by the reduction of several prothrombotic markers, including D-dimer, in patients     at high risk of arterial thrombosis. Such antithrombotic properties could also be observed in     patients at high risk of venous thrombosis. Aim of the study is to assess the effect of     statins on D-dimer levels in patients with previous VTE after oral anticoagulant treatment     withdrawal.   "
198452|NCT00437905|"     The purpose of this study to compare balloon angioplasty (PTA) vs. cutting balloon     angioplasty (CB-PTA) in terms of patency and postintervention inflammation in peripheral     artery disease.   "
198453|NCT00437918|"     In type 2 diabetic patients, tight blood glucose control often requires both fasting and     post-prandial glucose control separately. In the diabetic patients already on the insulin     glargine treatment for the control of fasting blood glucose, additional measures for the     control of post-prandial glucose level are often required. Nateglinide and acarbose are     frequently used for this purpose. We hypothesized that the short acting sulfonylurea     nateglinide may be more efficacious in diabetic patients with appreciable endogenous     insulin secretion, while acarbose may be more efficacious in patients with lower endogenous     insulin secretion. And we also want to clarify the clinical and biochemical parameters that     can predict the responsiveness to each agent in this multi-center randomized open cross-over     clinical study.   "
198454|NCT00437931|"     Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic     changes.Regional blood flow disturbances (including intrathyroidal) were also reported in     these thyroid disorders. The purpose of this study is to investigate the thyroid vascularity     and blood flow by Color Flow Doppler Sonography in patients with subclinical thyroid     dysfunction   "
198457|NCT00437970|"     This study compares metformin (current first-line medication) to pioglitazone (a newer     diabetic medication currently approved for combination use). Whilst there is good evidence     for the benefits of pioglitazone use in other populations, in light of the known weight gain     effects of pioglitazone we believe further assessment is required in Indigenous Australians     (in whom there is a strong predisposition for central fat deposition). This study will     provide evidence regarding the medication appropriate for first line medication in Type 2     diabetes in this high risk population. This study will assist clinicians to make     evidenced-based decisions regarding initial medical management of those with Type 2 diabetes     (where there is currently a gap in evidence).   "
198458|NCT00437983|"     The primary objective of this trial is to assess the ability of an oral administration of     Phosphatidylserine-Omega3 to improve attention and memory complaints in comparison to placebo     in age associated memory impaired subjects.   "
198459|NCT00437996|"     Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves     analgesia and reduces the frequency of motor blockade during epidural analgesia. several side     effects are possible mostly somnolence and hypotension. Association of continuous clonidine     infusion with low concentrations of levobupivacaïne and sufentanil was not studied during     labour. The objective of this study is to compare the effectiveness and the side effects of a     PCEA with levobupivacaïne 0,0625 % and sufentanil 0.25 microg.ml-1, without addition of     clonidine, and with addition of clonidine at a concentrations of 2 microg.ml-1.   "
198502|NCT00438568|"     The purpose of this study is to find out if insulin, when administered as a nasal spray     into the nasal passages, improves memory in adults with mild cognitive impairment (MCI) or     Alzheimer's disease.   "
198460|NCT00438009|"     The purpose of the study is to determine the safety and tolerability of two doses of     Coxsackievirus A21, administered 48 hours apart into a superficial melanoma tumour.      Injected and non-injected tumours will be observed regarding change in tumour size.      Coxsackievirus A21 (CVA21) is a naturally occurring virus, that is known to cause self     limiting upper respiratory infections. CVA21 has been shown in cell culture to infect and     kill human melanoma cancer cell lines. This property of CVA21 is due to the specific     receptors CVA21 uses in order to attach to, and infect a cell. The 2 receptors CVA21 uses to     infect a cell are Intracellular Adhesion Molecule 1 (ICAM-1) and Decay Accelerating Factor.     Both of these surface proteins are expressed on melanoma cell lines as well as human melanoma     tumours. Animal models of human melanoma tumours have demonstrated that CVA21 injection     either intratumour or intravenous causes infection in the tumours, resulting in reduction of     tumour size and growth.   "
198461|NCT00438022|"     Atopic Dermatitis (AD), also known as eczema, is a skin disease that causes the skin to be     hot, dry and scaly, and have severe itching. There are different kinds of eczema. Eczema     herpeticum (EH) is a type of eczema that spreads due to an underlying herpes virus infection.     The purpose of this research study is to identify the risk factors that may cause EH.   "
198462|NCT00438035|"     Postoperative pain stimulates the autonomic nervous system, induces the production of     pro-inflammatory substances, reduces patient mobility and impairs vital functions. The ECG     spectral analysis (ECGs) is a non-invasive marker of the autonomic nervous system state. To     our knowledge, the correlation between the sympathovagal activity quantified by a non     invasive method and the postoperative pain, has not been studied before.   "
198463|NCT00438048|"     The purpose of this study is to assess and compare the safetyness and efficacy of pilocarpine     drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by     SS in a multicenter, doubleblind, controlled trial.   "
198464|NCT00438061|"     Abdominal obesity is strongly associated with dyslipidemia, which may account for the     associated increased risk of atherosclerosis and coronary disease. Weight reduction is     suggested to be a preferred and effective first-line strategy to correct lipid abnormalities,     particularly in overweight/obese subjects. This improvement may be related to the effect of     reduction in abdominal fat mass on apoB and apoA-I metabolism, but this remains to be fully     demonstrated.      Hypothesis: Reduction in abdominal fat mass by weight loss decreases apoB concentration and     raises HDL-cholesterol chiefly by increasing LDL-apoB fractional catabolic rate (FCR), as     well as decreasing HDL apoA-I, respectively.   "
198465|NCT00438074|"     This study will investigate optical tissue characteristics as a function of neoadjuvant     breast cancer treatment. Our objective in this pilot study will be to identify diffuse     optical spectroscopy parameters that change with treatment and that may correlate with     pathological response. The ultimate goal is to use such parameters ultrasound as an early     predictor of pathological partial or complete response in women with locally advanced breast     cancer receiving treatment with neoadjuvant treatments such as chemotherapy or neoadjuvant     combined modality chemotherapy and radiotherapy.   "
198466|NCT00438087|"     Facial palsy after surgical removal of cranial base tumors adherent to the nerve can partly     be explained by inflammation.   "
198467|NCT00438100|"     To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary     chemotherapy in patients with inoperable or recurrent breast cancer.   "
198468|NCT00438113|"     Atrial fibrillation (AF) is a very common arrhythmia causing many symptoms resulting in     numerous hospitalizations. Catheter ablation is a technique that has evolved significantly to     improve symptomatic recurrences, but does not offer a 100% cure rate. We hypothesize that the     use of aggressive BP lowering will reduce the rate of recurrent AF after catheter ablation     for AF. We plan a randomized clinical trial of aggressive BP lowering versus standard BP     control to investigate this.   "
198469|NCT00438126|"     This is a randomized trial of an educational intervention to reduce the risk of diabetes     among urban American Indian women   "
198470|NCT00438139|"     The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol     (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety,     pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and     smoked marijuana to determine if there are potential significant interactions before     conducting outpatient studies.   "
198471|NCT00438152|"     This study will compare the benefit for patients switching from Kaletra® to Invirase® tablets     over remaining on Kaletra® (based on randomization), to elicit the lipid benefits inferred in     previous studies   "
198472|NCT00438165|"     To examine the impact of prenatal and infancy home visiting by nurses from child age 2     through 12.   "
198474|NCT00438191|"     DeQuervain's tenosynovitis is characterized by pain on the pain on the radial (thumb) side of     the wrist problems with thumb function. At this point, the standard care is to change daily     activities, use a thumb brace, and the possible use of painkillers. There is a difference in     opinion among physical therapists about how to use the splint in the treatment of DeQuervain     tenosynovitis. Some physicians tell patients to wear the brace at all times while other     therapists encourage patients to exercise and use the brace as needed. Both approaches to     using the splint are accepted as standard. The purpose of this study is to test and evaluate     these two ways of splinting and assess which one is better for patients with DeQuervain     tenosynovitis.   "
198476|NCT00438217|"     The goal of CPP-EDG 01 study is to assess possible genetic and/or environmental parameters     which may influence the growth rate of children affected by precocious puberty. In this view,     we are collecting clinical data and biological samples of children attended as outpatients at     the Pediatric Endocrine Center of Pisa from 1998 to present (the study is still open). From     biological (blood) samples, gene polymorphisms such as endocrine disruptor levels are     determined and compared to different growth pattern of pediatric patients treated with     different GnRH agonists.   "
198504|NCT00438594|"     To examine the impact of prenatal and infancy home visiting by paraprofessionals and by     nurses from child age 2 through 9.   "
198477|NCT00438230|"     ABSTRACT Background The optimal duration of oral anticoagulant treatment in patients with     idiopathic venous thromboembolism is still uncertain . The present study addressed the     possible role of the Residual Vein Thrombosis in assessing the need for a prolonged     anticoagulation.      Methods Patients with a first episode of symptomatic unprovoked or provoked proximal Vein     Thrombosis (VT) were given Oral Anticoagulant Treatment (OAT) for 3 months. Residual Vein     Thrombosis (RVT), ultrasonographically-detected, will be then assessed. Patients without RVT     did not continue OAT, whereas those with RVT will be randomized to either stop or continue     OAT for 9 more months. Patients were followed-up prospectively focusing on the study     outcomes: occurrence of recurrent venous thromboembolism and major bleeding over a period of     at least 12 months after OAT discontinuation.   "
198478|NCT00438243|"     This research is being done to look at the effects of Bromfenac, also called Xibrom for the     treatment of swelling in the retina (the light sensitive tissue in the back of the eye)     called macular edema that occurs after cataract surgery. Swelling in the retina can lead to     blurry vision.      The most commonly used treatment is eyedrops that decrease inflammation and may help stop     some of the swelling. The investigators want to see if the drug Bromfenac(Xibrom) can     decrease the swelling in the retina after cataract surgery and improve vision in these     patients.   "
198479|NCT00438256|"     A standard treatment for pancreatic cancer is radiation therapy plus chemotherapy after     surgery. Radiation therapy and chemotherapy are commonly given for up to six weeks. Previous     research has suggested that giving the radiation and chemotherapy for a shorter amount of     time (accelerated schedule) before surgery may be better tolerated. In this research study,     different schedules of proton radiation therapy will be used. Each schedule will give about     the same total dose of radiation. However, the total dose will be spread out over different     time periods and different numbers of sessions. The purpose is to find the shortest schedule     of radiation therapy that can be given without unacceptable side effects. Proton beam     radiation is being used because of its unique ability to deposit its energy directly in the     tumor, resulting in less radiation to normal tissue. A new type of PET scan is also being     studied to see if it can help predict the response to pre-surgery treatment.   "
198480|NCT00438269|"     Infection developing in the intensive care unit is a common complication of critical illness,     but notoriously difficult to diagnose. A definite diagnosis based on the most reliable tests     usually is not possible for at least two days. It is unclear what the optimal management     approach should be while awaiting the results of diagnostic tests. In some circumstances,     broad spectrum antibiotics are started with a plan to adjust them once the results of     cultures are available. Observational studies show that this results in greater antibiotic     use, and the risk of superinfection and resistance. In other circumstances, antibiotics may     be withheld pending the results of cultures, a strategy that leads to a delay in therapy when     cultures are positive, and that may be associated with a worse clinical outcome.      We undertook a randomized pilot study to address the question: In a critically ill patient     for whom clinicians are uncertain whether infection may be present, and in whom potential     sites of infection have been managed by removing or changing invasive devices, can a policy     of delaying antibiotic treatment until cultures are available reduce the risks of excessive     antibiotic use, without increasing the risks associated with delayed therapy?      Recognizing that the question has not been formally addressed before, and that approaches to     clinical management are both widely divergent and passionately held, our pilot study tested     the feasibility and acceptability of undertaking a larger trial with sufficient power to     determine equivalence.   "
198481|NCT00438282|"     To examine the impact of prenatal and infancy home visiting by paraprofessionals and by     nurses from child age 2 through 6.   "
198482|NCT00438295|"     The purpose is to measure the effect of glucose in the dialysis water on blood pressure,     pulse rate, and plasma glucose with and without body temperature control   "
198483|NCT00438308|"     The purpose of the study is to compare two common ways of rehabilitating after surgery for     distal radius fractures treated operatively with a volar plate.   "
198484|NCT00438321|"     The purpose of the study is to examine the effect of testosterone treatment on insulin in men     with the metabolic syndrome with testosterone levels at or below the lower end of the normal     range.   "
198498|NCT00438503|"     The purposes are 1. to measure the effect of dialysis with glucose in dialysis water on blood     pressure, pulse rate, plasma concentration of glucose, plasma concentrations og insulin,     glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and 2. to     analyse the relationship between the changes in blood pressure and changes in vasoactive     hormones   "
198525|NCT00438867|"     The purpose of this study is to determine whether a one-time intracoronary infusion of     Ad5FGF-4 is effective in reducing the time to onset myocardial ischemia as measured by     exercise treadmill testing and improving myocardial blood flow as measured by SPECT imaging.     Exercise capacity, angina functional class, patient symptoms and quality of life will also be     evaluated to characterize the efficacy of Ad5FGF-4. Short-term and long-term safety of     Ad5FGF-4 will also be evaluated.   "
198485|NCT00438334|"     Directional microphone hearing aids have been shown to provide benefit for individuals with     hearing loss in a number of laboratory experiments. However, few studies have investigated     the real-world, subject-reported benefit from these hearing aids, and even fewer have     examined directional hearing aid benefit across varying degrees of hearing loss. This study     will summarize data from a three-year, multi-faceted study of directional hearing aid     benefit. Ninety four subjects were divided into three hearing loss groups     (normal-to-moderate, mild-to-moderately-severe, and moderate-to-profound). These subjects     were then fit with experimental hearing aids set to either directional or omnidirectional     mode to determine if significant differences were present in hearing aid outcomes (both     subjective and objective). Both subject and experimenter were blinded to the hearing aid     settings. Following one month of use in each experimental setting, subjects completed: probe     microphone measurements, speech understanding in noise testing, use questionnaires,     subjective benefit scales, and satisfaction scales. At the conclusion of the study, subjects     rated their preferences for the experimental settings in quiet, noise and overall. Both     objective measures, as well as subjective data, were analyzed across hearing aid and hearing     loss conditions.   "
198486|NCT00438347|"     The purpose of this study is to examine the effect of aerobic fitness training on human     cognition, brain structure, and brain function of older adults.   "
198487|NCT00438360|"     The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a     day), when administered twice a week compared to continuous administration, in patients with     chronic plaque psoriasis.   "
198488|NCT00438373|"     The purpose of this study is to evaluate if there is an association between the serum LH     receptor expression on the day of hCG administration or the day of oocyte retrieval and the     retrieval rates at oocyte pick up   "
198489|NCT00438386|"     The purpose of this study is to determine whether aripiprazole is effective in the treatment     of refractory panic and generalized anxiety disorder.   "
198583|NCT00447941|"     Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of     SCA-136 in healthy male Japanese subjects   "
198490|NCT00438399|"     The scalp is one of the most common affected sites in psoriatic patients as 79% of them have     scalp involvement.It has also a psychological aspect with 31% of patients with scalp     psoriasis indicating distress.      Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not     always ideal because they might be inconvenient and messy to use, stain or damage hair.      The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the     tradename of Clobex®) was developed to provide the strongest available corticosteroid as a     short-contact therapy in order to improve the chances of it being effective and reduce the     potential for traditional side-effects.      The objective of this study is to compare subject's overall preference between Clobetasol     propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate     to severe scalp psoriasis.   "
198491|NCT00438412|"     The mechanisms involved in development and maintenance of hypertension in obstructive sleep     apnea are not clarified.      We hypothesize that patients with obstructive sleep apnea have an abnormal level of some     vasoactive hormones during apneic events during sleep.   "
198492|NCT00438425|"     The purpose of this trial is to re-evaluate the potential role of diet in modulating     cardiovascular risk factors. If potent lipid-lowering effects through novel dietary     interventions can be demonstrated, then diet may again be seen as providing an alternative to     drug therapy in the primary prevention of cardiovascular disease.      Aims:        -  To determine the percentage of lipid clinic attendees interested in making a serious          dietary change.        -  To determine the extent to which a self selected dietary portfolio combining viscous          fiber foods (oat & barley β-glucan, psyllium, etc.), soy and vegetable protein foods          (soy milk, soy meat analogues and almonds) and plant sterols (sterol margarine) in the          same diet be significantly more effective in reducing LDL-cholesterol and other markers          of cardiovascular disease risk than conventional dietary advice.        -  To determine whether this effect can be maximized by more frequent follow-up, and what,          if any, would be the relationship between dietary compliance and reduction in LDL-C.   "
198493|NCT00438438|"     The primary objectives of the proposed experimental and modeling efforts are to quantify the     influences of acute sleep deprivation (short-term homeostatic), chronic sleep restriction     (long-term homeostatic), circadian rhythmicity, and their interactions on neurocognitive     performance and to develop a new model of sleep homeostasis that can predict the effects of     chronic sleep restriction. This model will be based on the underlying neuroanatomy and     neurophysiology. This new model will facilitate optimization of human performance in     operational settings, such as are seen in military operation and other work environments.   "
198494|NCT00438451|"     In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older     receive three different antiepileptic drugs in a double-blind, randomized design over a     period of 58 weeks. All drugs are licensed for the treatment of epilepsy. The primary     endpoint of this study will be retention rate at 58-weeks, since it reflects both efficacy     and tolerability.   "
198495|NCT00438464|"     This randomized phase II trial studies how well finasteride works in treating patients with     stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of     prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by     lowering the amount of testosterone the body makes. Giving finasteride before surgery may     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.   "
198496|NCT00438477|"     RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the     nipple or near the tumor, may help doctors find out how far the disease has spread.      PURPOSE: This clinical trial is studying two different injection methods to compare how well     they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in     patients with invasive breast cancer.   "
198497|NCT00438490|"     Medications used to increase breast milk production increase prolactin secretion, the main     hormone of lactation. There are no FDA approved medications used to improve breast feeding,     but metoclopramide is used off-label and can have intolerable side effects. We examined the     biological activity and safety of recombinant human prolactin (r-hPRL) as a potential     medication to augment lactation. In this study, the effect of r-hPRL on breast milk     production in women who did not recently deliver a baby and its effect on the bones and     menstrual cycle were tested.   "
198499|NCT00438516|"     This project supports the post-third-grade assessment of 693 children and their families who     were enrolled in a randomized trial of a program of prenatal and infancy home visitation by     nurses that was epidemiologically and theoretically grounded. The project will determine     whether the beneficial effects of the program on maternal, child, and family functioning     extend through the early elementary school years, giving particular attention to maternal     life-course and children's emerging antisocial behavior. Assessments of the children will be     based on both mother and teacher reports. Teachers are independent, natural raters of the     children's adaptation to an important social context. There are numerous reasons to expect     that, from a developmental perspective, the effects of the program will increase as children     experience the increased academic demands associated with entry into third grade. In     addressing these questions, the current study will determine the extent to which this program     of prenatal and infancy home visitation by nurses can produce enduring effects on maternal     and child functioning (giving particular attention to the prevention of early-onset     disruptive behavior disorders) in urban African Americans that are consistent with those     achieved with whites in a central New York state county in a separate trial of this program     conducted over the past 20 years.   "
198500|NCT00438542|"     Cross sectional, hospital-based study dealing with adiponectin levels in newborns to mothers     with pre-eclampsia. Venus cord blood samples were collected immediately after birth; 30 cases     and 62 controls were enrolled into the study. The study was approved by the local ethics     committee and all participants gave written consent.   "
201609|NCT00479882|"     This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed     dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on     lipid values.   "
198505|NCT00438607|"     The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is     tolerated when given at different doses to patients with moderate to late-stage Parkinson's     Disease who are also taking the Parkinson's medication, levodopa (L-DOPA).      This study will also explore:        1. the pharmacokinetics of BIIB014 in Parkinson's patients who are also taking L-DOPA (this          will be done by measuring the levels of BIIB014 in the blood at several different times          during the study), and        2. the activity of BIIB014 when given to Parkinson's patients who are also taking L-DOPA          (this will be done by performing different Parkinson's Disease assessments during the          study to examine change in waking OFF time, change in time with troublesome dyskinesia,          change in Unified PD Rating Scale (UPDRS) scores, and Clinical Global Improvement).      Patients who enter this study will be randomly assigned to receive either BIIB014 or a     placebo but because the study is blinded, neither they nor their study doctor will know which     study treatment they are taking.      The study will be divided into 2 parts:        -  Part A: a, rapid, sequential cohort, dose escalation to establish MTD, followed by        -  Part B: a parallel-group exploration of the two highest tolerated doses versus placebo.      Note: As Part A of the study is now concluded, some of the study design information presented     below (e.g., number of study arms) pertains only to Part B.   "
198506|NCT00438620|"     Physical activity has been shown to have a positive effect on several quality of life     outcomes in cancer patients, but few existing studies have focused on the end stages of     cancer. The aim of this pilot study is to test the feasibility of a physical activity     intervention in advanced cancer patients, from which data can be used to design a randomized     controlled trial if results are encouraging.   "
198507|NCT00438633|"     The purpose of the study is to compare two common ways of rehabilitating after proximal     humerus fractures treated non-operatively.   "
198508|NCT00438646|"     This study will see if bacteria differ between children who have allergies or asthma and     children who do not have allergies or asthma. Previous research suggests that some bacteria     may protect against allergies and asthma. This study may provide more information on why some     children develop allergies and asthma.      Patients at the University of North Carolina-Chapel Hill School of Dentistry who are between     6 and 11 years of age may be eligible for this study.      Parents of participating children complete a questionnaire about the child and the child's     health. The child provides a saliva sample by chewing a small piece of wax and spitting in a     cup.      The saliva sample is analyzed in the laboratory for bacteria, yeast and antibodies     (substances the body produces to fight germs).   "
198509|NCT00438659|"     RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis     caused by radiation therapy. It is not yet known whether mometasone furoate is more effective     than a placebo in preventing radiation dermatitis.      PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it     works compared to a placebo in preventing radiation dermatitis in patients undergoing     radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma     in situ.   "
198510|NCT00438672|"     The purpose of the study is to compare the effectiveness of a steroid injection to a placebo     (inactive substance) in the treatment of lateral elbow pain, deQuervain's tendonitis, or base     of the thumb carpometacarpal (CMC) arthritis. We are also trying to identify which     personality factors and mindsets influence perceptions of elbow, wrist and hand pain. We hope     to enroll 213 subjects in this study.   "
198511|NCT00438685|"     Adolescent substance abuse results in significant negative outcomes and extraordinary costs     for youths, their families, communities, and society. Moreover, rates of psychiatric     comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual     diagnosis have worse outcomes and are more than twice as costly to treat than their     counterparts with no comorbidity. This project was a pilot test of a new treatment, OPTION-A,     which was adapted from Multisystemic Therapist (MST) and other evidence-based interventions     to specifically treat youth presenting for outpatient treatment of comorbid substance use and     internalizing disorders. The project was a randomized controlled pilot trial comparing the     experimental treatment to usual services in the community.   "
198524|NCT00438854|"     The purpose of this research study is to see if Dasatinib is effective and safe to give to     people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the     drug on LYN kinase activity in blood and bone marrow. Recent research shows that a key enzyme     in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory     studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells.     Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on     CLL cells.   "
198512|NCT00438698|"     Large observational studies have shown cereal fiber to protect from diabetes and heart     disease. Despite the success of acarbose, an α-glucosidase hydrolase inhibitor, which lowers     the glycemic index of foods containing starch, sucrose and maltodextrins, the use of diets     containing low glycemic index foods still remains to be established. We will therefore     provide otherwise healthy individuals with type 2 diabetes intensive counseling on food     selection either to improve glucose control using high cereal fiber dietary strategies or low     glycemic index foods. Studies will last 6 months with bloods taken for HbA1c, glucose and     blood lipids. If the study shows a benefit for either or both diets then use of high fiber     and/or low glycemic index foods in the diet may provide another potential way to improve     glucose control and lower cholesterol levels in non-insulin dependent diabetes.   "
198513|NCT00438711|"     This is a study for people with inflammatory bowel disease (IBD--that is, ulcerative     colitis, Crohn's colitis, or indeterminate colitis). We are studying how people with IBD     decide to have surgery when a doctor has told them they should think about having their colon     (large bowel) removed. This surgery is called a colectomy. Patients will be asked to fill     out a questionnaire that takes about 60 to 90 minutes to complete. Questions ask about     patients' background (age, etc.) and their IBD. They also ask about patients' decision to     have surgery or not to have surgery. For instance, what kinds of things did they think about?     Some questions ask about other people who affected the choice and how patients felt about the     help they got from others. People who wish to join the study will receive payment to thank     them for their time.        -  Patients must be at least 18 years old        -  Patients must speak English        -  Patients must have been told by their doctor to think about having surgery to take out          their colon to (a) lower their risk for cancer or (b) because they have pre-cancer          (called dysplasia)        -  Patients do not need to have had the surgery--they may have already had the surgery,          they may not have had it yet, or they may have decided they do not want to have it   "
198585|NCT00447967|"     This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan     and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with     locally advanced or metastatic gastric cancer   "
198514|NCT00438724|"     The purpose of this study is to test the efficacy of a new couples counseling intervention     for people recently diagnosed with early Alzheimer's disease and their spouses. The study     hypothesis is that counseling the couple shortly after the diagnosis, and while the     functional impact of the illness is still relatively mild, will have a significant impact on     their ability to provide support for each other.   "
198515|NCT00438737|"     RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may     also stop the growth of tumor cells by blocking blood flow to the tumor.Drugs used in     chemotherapy, such as leucovorin, oxaliplatin, and fluorouracil, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving cetuximab together with combination chemotherapy and bevacizumab before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed. Giving these treatments after surgery may kill any tumor cells that remain after     surgery.      PURPOSE: This randomized phase II trial is studying the side effects and how well giving     cetuximab together with leucovorin, oxaliplatin, and fluorouracil works with or without     bevacizumab in treating patients with resectable liver metastases from colorectal cancer.   "
198516|NCT00438750|"     The purpose of this study is to compare to ways of rehabilitating after surgery for distal     radius fractures treated operatively with a volar plate.   "
198517|NCT00438763|"     Carpometacarpal Thumb Arthritis is a disease caused by different factors and attacks mainly     woman older than 50 years. The signs and symptoms consist in pain, swelling, joint     instability, deformity and loss of motion. Some evidence has shown that splinting of the     thumb may be of benefit. There are two methods of splinting: The first is Standard Neoprene     wrap-on thumb support (in which the finger is kept in the same position with in a standard     Neoprene thumb splint). The second is Thermoplast Short Opponens splint (This splint is     custom-made and the thumb is use as a template to design the splint). The purpose of this     study is to test and evaluate these two protocols of splinting and assess which one helps or     works better in patients with thumb arthritis.   "
198518|NCT00438776|"     The purpose of this research study is to evaluate the efficacy (effectiveness) and safety of     olanzapine in treating pathological gambling.   "
198519|NCT00438789|"     The primary objective is to provide access to eculizumab for PNH patient pending commercial     availability.   "
198520|NCT00438802|"     RATIONALE: Combinations of biological substances in alefacept may be able to carry     cancer-killing substances directly to cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of alefacept in     treating patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell     non-Hodgkin's lymphoma.   "
198521|NCT00438815|"     The study objective was to evaluate the safety and efficacy of repeat use of C1INH-nf for the     treatment of acute HAE attacks.   "
198522|NCT00438828|"     Radiation treatment is often recommended as a safe and quick treatment that gives most people     good relief from bone pain within a couple of weeks. However, some people can experience a     short episode of increased pain (called a 'flare') a day or two after radiation treatment,     that lasts about a day. The purpose of this sturdy is to find out if a medication called     dexamethasone can help prevent pain flare as a result of radiation therapy.   "
198523|NCT00438841|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Thalidomide may stop the growth of cancer cells     by blocking blood flow to the cancer. Giving bortezomib together with cyclophosphamide,     dexamethasone, and thalidomide may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with     cyclophosphamide, dexamethasone, and thalidomide works in treating patients with newly     diagnosed, previously untreated multiple myeloma.   "
198526|NCT00438880|"     RATIONALE: Biological therapies, such as agatolimod sodium, may stimulate the immune system     in different ways and stop cancer cells from growing. Monoclonal antibodies, such as     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab     tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming     normal cells. Giving agatolimod sodium together with rituximab and yttrium Y 90 ibritumomab     tiuxetan may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of agatolimod     sodium when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see     how well it works in treating patients with recurrent or refractory non-Hodgkin lymphoma.   "
198527|NCT00438893|"     The purpose of this study is to evaluate the long term effectiveness of the dietary     portfolio, consisting of viscous fibers, soy products, nuts and plant sterols, as well as the     effects of removing single food components from the dietary portfolio on cholesterol     reduction and other cardiovascular risk factors.   "
198528|NCT00446849|"     To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX     mesalamine once daily.   "
198529|NCT00446862|"     The primary hypothesis is that titration of ACE inhibitor and Angiotensin Receptor Blockers     (ARBs)to reduce urine protein excretion to < 500 mg per day in Fabry Patients receiving     agalsidase beta therapy at 1 mg/kg every two weeks will slow the progression rate of decline     of glomerular filtration rate (GFR) compared to case controls drawn from the     Genzyme-sponsored Phase III extension study (GFR 60 to 125 ml/min/1.73 m², urine protein > 1     gram/day) or the Phase IV study (GFR 20 to 60 ml/min/1.73 m², urine protein > 0.5 gram/day).     After a 3 month initial Evaluation Phase, the patients will be followed during a 24 month     Observation Phase. FAACET is an open label, prospective observational study. The primary     objective is reduction of first morning urine protein/creatinine ratio to < 0.5 gram/gram.     The primary outcome measure is the regression slope of MDRD GFR with time in years   "
198530|NCT00446875|"     The purpose of this study is to examine the analgesic properties of oral sucrose during     routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will     significantly decrease the objective measures of acute pain during routine immunizations.   "
198531|NCT00446888|"     The purpose of the study is to compare two different nutritional supplements with respect to     their effect on building muscle, and to determine the factors that control the rate at which     muscle tissue can be produced in subjects with cancer. After three days of receiving all     meals from the Reynolds Institute on Aging in order to stabilize their diet, subjects will     then return to the Institute to perform a single day study, where they will be given one of     two supplements to drink. Blood will be taken from a catheter placed in one of their arms and     three muscle biopsy samples will be taken from a leg. Subjects will have x-ray evidence of     cancer and be 40 years of age or older in order to participate. It is the hypothesis that a     nutritional supplement with a high amount of protein and containing leucine will target the     metabolism problems in cancer patients.   "
198532|NCT00446901|"     The aim of this study is to determine whether selenium supplementation leads to changes in     selenium levels and gene expression profiles in prostate tissue.   "
198533|NCT00446914|"     This program developed by the HSFO aims at helping people of Ontario and their primary     healthcare providers better diagnose, manage and control high blood pressure. The High Blood     Pressure Strategy brings together healthcare providers and patients to improve the way in     which family doctors, nurse practitioners and pharmacists work together and with patients     towards improved control of high blood pressure through the use of evidence-informed tools     combined with local systems change.   "
198534|NCT00446927|"     The current method of evaluating the surgical repair during surgery is limited to     echocardiography (a noninvasive diagnostic procedure that uses ultrasound to study the     structure and motions of the heart) or an invasive procedure called cardiac catheterization.      The SPY imaging system makes use of the fluorescence properties of indocyanine green (ICG) to     obtain high quality images in blood vessels. ICG is a green dye used to test heart output.     The use of the SPY imaging system during surgery may provide valuable information regarding     successful vessel connection and the area remaining unblocked.      This study will compare the results of images to echocardiography and conventional     angiography results.      With SPY imaging, congenital heart surgeons would be able to check the quality of the     procedure and revise, redo or perform additional procedures as dictated by the images before     the patient leaves the operating room.   "
198535|NCT00446940|"     Different Doses of rosuvastatin and atorvastatin will be used to see if HCV viral load     changes and liver tests change.   "
198536|NCT00446953|"     Comparison of two randomized group :        -  caesarean section planned at 38 weeks after 2 antenatal injections of 12 mg of          betamethasone 48 h before.        -  caesarean section planned at 39 weeks without corticosteroid.      The aim is to demonstrate that programming caesarean section at 38 weeks of pregnancy, after     antenatal corticosteroid, allows to avoid caesarean section in emergency (because of a labour     before 39 weeks), without increasing the neonatal respiratory distress rate.   "
198537|NCT00446966|"     The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids     reduce atrial fibrillation and other outcomes after cardiac surgery. In this     placebo-controlled trial, patients undergoing elective coronary artery bypass graft surgery     with or without valve repair will be treated with omega-3 polyunsaturated fatty acids     perioperatively. The following hypotheses will be tested: 1. omega-3 polyunsaturated fatty     acids reduces the incidence of atrial fibrillation (AF) after cardiac surgery, 2. omega-3     polyunsaturated fatty acids, administered in the perioperative period for cardiac surgery,     decreases postoperative complication rates, and 3. omega-3 polyunsaturated fatty acids     decrease intensive care unit and hospital length-of-stay.   "
198538|NCT00446979|"     This study will help determine whether UC-781 gel is safe when applied to the vagina twice     daily for 14 days, and will assess whether women and men find the gel acceptable to use.   "
198539|NCT00446992|"     The purpose of this study was to describe metabolic changes in the first 16 weeks of     anti-psychotic treatment in previously drug-naïve patients with psychosis.      We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment     predicts a disproportionately greater increase in insulin resistance with olanzapine     treatment.   "
198586|NCT00447980|"     The purpose of this study is to look at the safety and effectiveness of CNTF implants on     vision in persons with retinitis pigmentosa, Usher type II & III, and Choroideremia. This     research is being done because there are no effective therapies for people with these retinal     degenerations. They are genetic disorders that affect one's ability to see at night, and     later cause tunnel vision and loss of central vision. Retinal degenerations affect the     retina, a light sensitive layer of cells in the back of the eye. Slowly over time, these     cells die and cause permanent loss of vision.      The implant is a small capsule that contains human retinal pigment epithelium cells. These     cells have been given the ability to make CNTF and release it through the capsule membrane     into the surrounding fluid. In this study, two different CNTF dose levels will be used: a     high dose and a low dose in one eye, as well as a sham (or placebo) surgery in the other eye.   "
198542|NCT00447031|"     Exudative age related macular degeneration (ARMD) is most common cause of blindness in old     population. It is clear that no single therapy addresses the multifactorial pathogenesis of     the disease. Recently, studies of intravitreal anti-VEGF therapies such as pegaptanib and     bevacizumab have shown the beneficial effect in visual acuity in the treatment of neovascular     ARMD. However, the problem with these intravitreal injections is that therapy must be     frequently administered for a prolonged but unknown period of time to maintain the benefit.     Prolonged, frequent injections may be associated with additional safety risk,lack of     convenience and high treatment cost.      Intravitreal steroid injection with anti-inflammatory properties limits any further VEGF     upregulation initiated by the inflammation which has been known as one of the pathogenesis     and causes of recurrence after the treatment of the neovascular ARMD.      The researchers hypothesize that the combined treatment of intravitreal bevacizumab and     triamcinolone acetonide may decrease the recurrence rate after the treatment and obviate the     frequent intravitreal injections in the treatment of neovascular ARMD.      In this study, the researchers will compare the recurrence rate of combined treatment of     intravitreal bevacizumab and triamcinolone acetonide versus intravitreal bevacizumab alone in     the treatment of neovascular ARMD.   "
198543|NCT00447044|"     The purpose of this study is to see if a combination of resistance exercises and amino acid     capsules can reduce muscle loss and maintain muscle function during bedrest. This experiment     will imitate many of the physical conditions experienced by astronauts during space flight by     examining the effects of resistance exercise or nutrition on muscle during 2 days of bedrest.     The diet of astronauts will also be imitated by providing diets in the General Clinic     Research Center.   "
198544|NCT00447057|"     This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect     of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line     setting (such as progression-free survival [PFS], disease control rate, best response rate,     time to treatment failure [TTTF], overall survival [OS] and 1-year survival rates) compared     to pemetrexed plus erlotinib combination.   "
198545|NCT00447070|"     It is known that certain antiviral therapies, the socalled protease inhibitors, used in the     treatment of HIV infection has an untowarded effect on the blood vessels, promoting early     occurence of atherosclerosis. A a newer protease inhibitor, atazanavir, has been shown to     have no negative effect on the levels of blood cholesterol and it is hypothesized that this     may indicate that atazanavir is less prone to induce atherosclerosis. An early sign of     atherosclerosis is a reduced vasomotion and this study investigate the influence of     atazanavir on functionality of the conduit blood vessels compared to that of standard     antiviral therapy.   "
198546|NCT00447083|"     -  To establish whether ultraviolet light exposure acutely reduces perceptions of pain in          patients with fibromyalgia.        -  To establish whether a series of UV light exposures has a cumulative effect on          fibromyalgia pain.   "
198547|NCT00447096|"     This research study evaluates an experimental device for the treatment of the depressed phase     of Bipolar Disorder Type II. Repetitive Transcranial Magnetic Stimulation (rTMS) is an     experimental procedure where a device delivers an alternating magnetic field to a focal area     of the brain. When the coil is placed against the scalp on the left frontal area of the head,     the magnetic field is focused to a region of the brain that is thought to be involved in     depression. This study is intended to test if rTMS can affect this region of the brain in a     way that improves the symptoms of depression related to Bipolar Disorder Type II. The purpose     of this study is to obtain safety and efficacy information regarding the use of     rTMS(Repetitive Transcranial Magnetic Stimulation) for patients in the depressed phase of     Bipolar Disorder Type II.   "
198548|NCT00447109|"     The purpose of this study was to compare the incidence of ventilator-associated pneumonia     between two groups of patients randomised to have closed system suction catheter changes     every 24 hours and patients having closed system suction catheter changes every seven days or     as required.   "
198549|NCT00447122|"     Phase II study of lapatinib and gemcitabine for patients with metastatic pancreatic cancer.   "
198550|NCT00447135|"     The purpose of this research is to learn more about the function of the body's ability to     fight infection when the immune response is activated when injury occurs, in the elderly     population.   "
198551|NCT00447148|"     Aim of this study is to evaluate whether the length of coronary segments, assessed by an     experienced operator, using the optimal view of standard 2-dimensional coronary     angiography, is over/underestimated with respect to the one evaluated automatically with the     help of a 3-dimensional coronary reconstruction model. Moreover, both techniques are compared     with an in-vivo surrogate of the real length of the coronary segment under evaluation, i.e.     an intra-coronary marker guide-wire, which is a wire with markers placed at fixed and known     distance along its length in its distal (intra-coronary) part. Two hypotheses are tested: (1)     the length of a coronary segment evaluated with a standard 2-dimensional optimal view     over/underestimates the length assessed by a 3-dimensional coronary model that automatically     detects the least foreshortened length of the segment under evaluation, and (2) the     3-dimensional model approximates more closely than standard 2-dimensional angiography, the     real length of the segment detected by the marker guide-wire.   "
198552|NCT00447161|"     To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic     associated diarrhea among hospitalized immunocompetent Filipino children.   "
198584|NCT00447954|"     The purpose of this study is to look at the safety and effectiveness of CNTF implants on     vision in participants with atrophic macular degeneration. This research is being done     because there are no effective therapies for people with atrophic macular degeneration.     Age-related macular degeneration (AMD) is a condition that affects the macula, the central     part of the retina that we use for seeing details. There are two types of AMD, one is the wet     type in which new blood vessels grow, also known as choroidal neovascularization (CNV), but     the other is the dry type in which the healthy cells die, and that is the target of this     study. This is called atrophic macular degeneration. The implant is a small capsule that     contains human retinal pigment epithelium cells. These cells have been given the ability to     make CNTF and release it through the capsule membrane into the surrounding fluid. In this     study, two different CNTF dose levels will be used: a high dose and a low dose, as well as a     sham surgery (or placebo) group.   "
198553|NCT00447174|"     1. Develop a treatment for clinically significant parental bereavement. The proposed          treatment development activities include:             1. Development of a treatment manual, associated fidelity rating forms, and training               aids,             2. Pre-testing the treatment manual with bereaved parents, and revision in               consultation with treatment development experts,        2. Conduct a randomized, wait-list control, pilot study of the proposed treatment:             1. Measure treatment-related change in (a) complicated grief symptoms, the primary               outcome variable, which will be assessed using the Inventory of Complicated Grief,               and, (b) marital adjustment, the secondary outcome measure, to be assessed using               the Dyadic Adjustment Scale. These outcomes will be assessed in treatment and               control groups at baseline, at treatment conclusion, and at three month follow-up.             2. Test the difference between the treatment and control groups on changes from               baseline to three month follow-up on the exploratory outcome variables of PTSD,               depression, social and work impairment, and quality of life             3. Estimate effect sizes of these differences in changes in outcomes        3. Develop a proposal for a randomized controlled trial of the treatment, based on the          results of aim 2.   "
198554|NCT00447564|"     Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral     tablets, patients experience withdrawal and cravings when the variable BPN levels in the     blood are low. Probuphine is an implant placed just beneath the skin that contains BPN. It is     designed to provide 6 months of stable BPN blood levels. This study will test the safety and     efficacy of Probuphine in the treatment of patients with opioid dependence.   "
198555|NCT00447577|"     The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in     the treatment of ocular inflammation associated with blepharokeratoconjunctivitis   "
198556|NCT00447590|"     The purpose of this study is to determine whether the LAP-BAND system is safe and effective     in morbidly obese adolescents.   "
198557|NCT00447603|"     The purpose of this study is to test the safety and effectiveness of Losartan as compared to     Losartan/HCTZ in pediatric patients (6 to 17 years) with high blood pressure.   "
198558|NCT00447616|"     The purpose of establishing the database is to evaluate the effects of surgical removal of     the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall     health.   "
198559|NCT00447629|"     A study evaluating the safety of a high and low dose of PPM-204 on the electrical pathways of     the heart.   "
198560|NCT00447642|"     This study will evaluate the use of LX201 to prevent future graft rejection episodes and/or     graft failure in patients who have undergone corneal transplantation and who have recently     experienced a rejection episode due to an immune response.   "
198561|NCT00447655|"     Limb loss can result from a variety of etiologies including diabetes, trauma and cancer.     Following limb loss, individuals are at elevated risk for activity limitations and     participation restrictions with significant impact on health and quality of life.     Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and     established the effectiveness of a self-management program (PALS) to improve health and     outcomes following limb loss. Literature suggests that the access to, and effectiveness and     utilization of, this class of interventions may be enhanced by the concerted use of early     intervention, peer mentorship, motivational interviewing and provider training. Objectives:     Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention-     PALS Plus. The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention     in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS     Plus intervention in maximizing utilization of self-management interventions for persons with     limb loss. A cohort of 200 patients will be enrolled prior to implementation of the     intervention and will serve as the control group. Subsequently, a second cohort of 200     patients will be enrolled and receive the PALS Plus intervention and will serve as the     intervention group. Assessment will be at baseline, treatment completion and six month     follow-up. Outcomes: Primary outcome measures are: pain, depressed mood, and positive mood.     Secondary outcome measures are: function, participation and bothersomeness of limitations.     The investigation will also provide unique and valuable information regarding patients'     acceptance and use of peer visitation and self-management following limb loss. Relevance: By     establishing the utility and effectiveness of the enhanced self-management intervention,     there is the potential to improve the health, activity, participation and quality of life for     individuals with disabilities. The intervention addresses the areas of activity and     participation in such a way that it can be implemented in local health care facilities     working in combination with a national consumer based organization - the Amputee Coalition of     America.   "
198562|NCT00447668|"     This study will compare the effectiveness of yoga classes, exercise classes, and a self-care     book in the management of pain and function for people with low back pain.It will also for     physical, psychological and physiological factors associated with improvement in back pain.   "
198563|NCT00447681|"     This a randomized, double-blind placebo-controlled inpatient/outpatient, sequential group     study of ascending single IV doses of ILV-094, an investigational drug, administered to     healthy subjects. In addition, there will be one sub-cutaneous dose cohort, which will follow     the 25 mg IV dose.   "
198564|NCT00447694|"     The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in     beta-thalassemia patients with deferasirox treatment.   "
198576|NCT00447850|"     Previous studies have suggested that premature luteinization (PL)during controlled ovarian     stimulation (COS) decreases the implantation rate due to a negative effect on the endometrium     receptivity. This study aims to describe the impact on endometrial gene expression of PL in     GnRH antagonist and GnRH agonist cycles.   "
198577|NCT00447863|"     Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed     as an oral contraceptive (birth control pill). The purpose of this trial is to compare     different preparations of LNG/EE by assessing the way they are absorbed into the blood.   "
198578|NCT00447876|"     This study will investigate the hypothesis that the analgesic effect of a single injection of     Dysport (200 MU) induces a significant reduction of symptoms in chronic cases of plantar     fasciitis.   "
198579|NCT00447889|"     This is a clinical study of gadoteric acid in non-coronary MR angiography.   "
198565|NCT00447707|"     This is a randomized, controlled trial of Positive Choice, an interactive multimedia computer     program, to determine whether it can detect and reduce risky behaviors among HIV-positive     adults. The behaviors of interest are: unprotected anal or vaginal intercourse, illicit drug     use, risky alcohol drinking, and failure to disclose HIV status to sex partners. The Positive     Choice program is integrated into the routine operations of outpatient HIV clinics, where     participating patients complete an in-depth risk assessment (computerized health     questionnaire) before a regularly scheduled medical appointment. Participants assigned to the     intervention arm receive brief, interactive risk-reduction counseling by an actor-portrayed     Video Doctor and an educational worksheet. Their health care provider receives as summary     cueing sheet, alerting them to the patient's risky behavior and readiness to change. Control     participants complete the computerized risk assessment and receive the clinic's usual care.     Three months after a baseline visit, intervention and control group patients are invited back     to complete an additional risk assessment. The intervention group also receives a booster     intervention. Six months after baseline, both groups complete a final risk assessment.   "
198566|NCT00447720|"     This study seeks to examine the effectiveness of translating two proven interventions,     RESPECT, and the NIDA Community Based Outreach Model, into one program of education, PATH, to     be delivered by case managers to their seriously mentally ill, substance abusing clients.      The objective is to teach case managers to assess the specific risk profiles of their     clients, and then create a plan of intervention aimed at reducing high risk sexual and     substance abusing behaviors.   "
198567|NCT00447733|"     The purpose of this study is to determine whether Integrated Treatment is effective in the     treatment of anxiety and/or depression with co-occurring substance use disorders.   "
198568|NCT00447746|"     Gastric cancer remains the second most common cancer worldwide.Although the prognosis is poor     for majority of patients , long term survival is achievable in patients in whom surgical     resection is possible.      However the results of surgery are generally disapointing in most large series.The exception     to this appears to be Japan and far east where a standardized approach to surgery is     undertaken with low morbidity and mortality.The extent of surgery and particularly the     development of systematic lymphadenectomy(D2)has been credited in Japan for the improved     outcome in patients with gastric cancer.      Hence for comparing the difference between D1 and D2 lymphadenectomy for gastric cancer in     terms of overall survival,disease free survival and loco regional recurrence and also post     operative morbidity and mortality following both these procedures,this study has been     undertaken.      In D1 lymphadenectomy, only those lymph nodes which are adjacent to the part of stomach being     resected will be removed.In D2 lymphadenectomy other lymph nodes draining the stomach will     also be removed according to internationally accepted guidelines and also include resection     of greater omentum along with anterior layer of transverse mesocolon and lesser omentum upto     its attachment to hepatoduodenal ligament.      Currently both these procedures are widely practised worldwide and there is no definite     evidence showing the superiority of one procedure over the other.Neither is any of these     procedures experimental.      We are doing this trial to see whether one of these procedures is superior to the other.   "
198569|NCT00447759|"     The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamline safety study     designed to compare the cardiovascular safety of celecoxib versus traditional non-selective     Non Steroidal Anti-Inflammatory Drug (NSAID) therapy.Traditional NSAID's are associated with     significant morbidity and mortality from gastrointestinal toxicity. Cyclooxygenase 2     (Cox-2)selective agents are associated with reduced upper gastrointestinal     toxicity.Traditional NSAID's and Cox-2 inhibitors may also be associated with cardiovascular     and renal disorders. Data from both randomised and observational studies suggest that     celecoxib has similar or reduced cardiovascular toxicity when compared to traditional     NSAID's. However, the overall safety balance of a strategy of celecoxib therapy versus a     strategy of NSAID therapy is unknown. The European Medicines Evaluation Agency (EMEA) has     requested that studies of the cardiovascular safety of celecoxib be carried out within the     indicated population of Europe. This study addresses these issues by comparing the     cardiovascular safety of celecoxib therapy with traditional NSAID therapy in the setting of     the EU healthcare system.      As of May 2013, 7300 patients had been randomised, and had accrued an average 4.2 years of     follow up by the end of May 2014.   "
198570|NCT00447772|"     The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most     frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly     laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be     assigned to one of the two basic types of cervical dystonia, either predominantly rotational     torticollis or predominantly laterocollis on the basis of clinical examination. This will     determine which therapy is to be administered, using the clearly defined, structured     injection protocols.   "
198571|NCT00447785|"     This study is about the endocrine regulation of energy and fluid supplies in alcoholic     patients. A large proportion of energy and fluid is supplied by alcohol beverages in     alcoholic patients. In this study, we evaluated the importance of these supplies with a     detailed questionnaire, a nutrition software that evaluated the importance of each macro- and     micronutrients and correlated these values with several hormones such as Leptin, Insulin,     Cortisol, Ghrelin, and PYY involved in the regulation of energy balance or AVP involved in     the regulation of plasma osmolality   "
198572|NCT00447798|"     The proposed study uses a two-arm randomized experimental design to evaluate the efficacy of     a brief, theoretically-guided, Prevention Care Advocate intervention with HIV-positive     crack users. Study participants will be recruited from the HIV inpatient hospital wards of     two inner-city hospitals that serve a similar population of HIV-positive patients: Jackson     Memorial Hospital (JMH) in Miami, Florida and Grady Memorial Hospital (GMH) in Atlanta,     Georgia.   "
198573|NCT00447811|"     This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics     of MOA-728 in subjects on stable methadone maintenance.   "
198574|NCT00447824|"     Hypothesis:        1. May the introduction of NIDCAP during blood sample reduced pain in neonates during blood          sample        2. Compare the effect of venous and capillary blood sample method   "
198575|NCT00447837|"     The primary objective of the study is to evaluate the safety and efficacy of SPRC-AB01 versus     placebo for treatment of chronic sinusitis in subjects who have had sinus surgery.   "
198580|NCT00447902|"     The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV     or hepatitis B virus (HBV) co-infected HIV+population, three-class (NRTI, NNRTI, and PI)     experienced, with documented resistance to more than one PI. Determine pharmacokinetic data     in this co-infected population and potential utility of using therapeutic drug monitoring     (TDM) in improving efficacy outcomes.   "
198581|NCT00447915|"     To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to     patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by     oral administration every day. To evaluate also the dose response of R484iv.   "
198582|NCT00447928|"     The purpose of the study is to evaluate the effectiveness and safety of the use of low-dose     nitroglycerin transdermal patches to treat pain and function in chronic tennis elbow.   "
198587|NCT00447993|"     The purpose of this study is to look at the safety and effectiveness of CNTF implants on     vision in persons with retinitis pigmentosa, Usher type II & III, and Choroideremia. This     research is being done because there are no effective therapies for people with these retinal     degenerations. They are genetic disorders that affect our ability to see at night, and later     cause tunnel vision and loss of central vision. Retinal degenerations affect the retina, a     light sensitive layer of cells in the back of the eye. Slowly over time, these cells die and     cause permanent loss of vision.      The implant is a small capsule that contains human retinal pigment epithelium cells. These     cells have been given the ability to make CNTF and release it through the capsule membrane     into the surrounding fluid. This study will look at the effect of the implant on vision loss     by retinitis pigmentosa, Usher type II & III, and Choroideremia. In this study, two different     CNTF dose levels will be used: a high dose and a low dose in one eye, as well as a sham (or     placebo) surgery in the other eye.   "
198588|NCT00448006|"     The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent     in malignant obstructions of the common bile duct.   "
198589|NCT00448019|"     The goal of this clinical research study is to learn if the combination of fludarabine,     cyclophosphamide, rituximab, and bevacizumab is effective in treating chronic lymphocytic     leukemia in patients who have already been treated with chemotherapy. The safety of this     treatment will also be studied.   "
198590|NCT00448032|"     A study evaluating the safety and pharmacokinetics of multiple oral doses of an     investigational oral diabetic agent when given to healthy Japanese male volunteers.   "
198591|NCT00448045|"     It is known that individuals with spinal cord injury are at increased risk for respiratory     tract infections like pneumonia. Part of this risk is due to weakened chest and abdominal     muscles that are vital to deep breathing and the ability to cough. The purpose of this study     is to look at the effectiveness of two different treatments in preventing pneumonia and other     respiratory problems in persons with SCI.      This is a randomized controlled trial investigating the effectiveness of two different     treatments. Participants will be randomly assigned to one of the two treatment groups. They     will not be told the details of the other intervention since this could influence or change     their activities during the study.   "
198592|NCT00448058|"     To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the     treatment of outpatient subjects with Major Depressive Disorder (MDD)   "
198593|NCT00448071|"     MTR107 effect on blood pressure throught the dialysis procedure and its ability to prevent     Intra dialytic Hypotension   "
198594|NCT00448084|"     This study will use functional MRI (fMRI, a technique that shows what areas of the brain are     active when performing different mental tasks), to examine how the brain in people with     functional movement disorders (FMD) may differ from that in people without FMDs. People with     FMD have movement symptoms they feel they cannot control and that are not due to a known     medical disorder. Previous studies looking at the brain activity of FMD patients have found     areas in the frontal lobe of the brain that appeared overactive. These overactive areas may     make it difficult to perform complex mental tasks. Studying the brain during performance of     these tasks may enhance knowledge about FMD.      Patients 18 years of age or older with an FMD and healthy normal volunteers may be eligible     for this study. Participants have two visits to the NIH Clinical Center for the following     procedures:      First visit (screening):        -  Medical history and neurological examination.        -  Urine drug screen for illicit drugs.        -  Psychological testing, including an interview and questionnaires.      Second visit:        -  Brain MRI (if one has not been done at NIH within the past 12 months): MRI uses a          magnetic field and radio waves to produce images of body tissues and organs. The subject          lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing          earplugs to muffle loud noises that occur during the scanning process. The procedure          lasts about 2 hours, during which time the patient is asked to lie still for up to 30          minutes at a time.        -  Brain fMRI: While in the MRI scanner, subjects read questions and answer them yes or no          by pushing buttons. They are asked to answer questions about their health, their          movement symptoms and unrelated topics (like personal preferences and current events).          The questions vary in difficulty. Sometimes subjects are instructed to answer correctly;          other times they are asked to answer incorrectly. A strap is placed around the subject's          chest and two wires are taped to the fingers to monitor heart rate, breathing rate and          sweat response during the scan. The scan takes about 2 hours.   "
198595|NCT00448097|"     The purpose of this study is to differentiate between the administrations of Cetuximab alone     vs. Cetuximab plus Docetaxel in the treatment of non-metastatic prostate cancer before the     surgical removal of the prostate.   "
198596|NCT00448110|"     This study will compare repeated intermittent IV dosing of diclofenac in patients with     moderate to severe post-surgical pain from abdominal or pelvic surgery.   "
198597|NCT00448123|"     To determine if emergency department patients with acute ureteral colic pain due to a     ureteral stone who are treated with tamsulosin, versus placebo, will experience a shorter     time to passage of their stone or resolution of their pain. A secondary study objective will     be to determine if there is a relationship between response to tamsulosin and stone size or     position in the ureter.   "
198598|NCT00448136|"     This 2 arm study will assess the efficacy and safety of two systemic treatments including     Avastin in patients with previously-untreated progressive locally advanced/metastatic     well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm     1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin     500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks.     Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po     bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated     with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or     unacceptable toxicity. The anticipated time on study treatment is until disease progression     or unacceptable toxicity, and the target sample size is <100 individuals.   "
198599|NCT00448149|"     The purpose of this study is to see whether the combination for RAD001 and Nexavar® works     better when given together than they do alone. The purpose of the first phase of this study     is to determine the best dose of RAD001 given with Nexavar®, and to see what effects, good     and/or bad, the study drug has on the subject and the subject's tumor. This study will also     observe side effects experienced by the subject.   "
198614|NCT00448344|"     The overarching aim of the study is to evaluate in a randomized trial the impact of a     family-supported intervention compared to a standard veteran-focused telephone counseling     control group to promote smoking cessation among cancer and heart disease patients.   "
198891|NCT00443755|"     The objective of this study is to determine whether targeted pharmacological improvement of     insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory     cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.   "
198600|NCT00448162|"     The variations of ENaC have an impact on the degradation of epithelial sodium channels and     sodium reabsorption, and thus are associated with hypertension and hypokalemia.      Liddle's syndrome is a rare monogenic form of autosomal-dominant hypertension caused by     truncating or missense mutations in the C-termini of epithelial sodium channel β- or     γ-subunit encoded by SCNN1B or SCNN1G. Our purpose is to determine the hotspot of mutation     causing Chinese Liddle's syndrome.      The second purpose is to determine wether the polymorphisms of ENaC are associated with     hypertension in Chinese. Some polymorphisms of ENaC associated with hypertension may be     genetic risk factors for Chinese hypertension.   "
198601|NCT00448175|"     The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug     therapy for the treatment of symptoms of overactive bladder (OAB).   "
198602|NCT00448188|"     Since many of the patients in an intensive care unit suffer from disorders of hemostasis,     bleeding is a main concern applying central venous catheters. Even if there are some data     indicating elevated international normalized ratio may not increase the risk of bleeding no     clear cut-off has been defined so far. An INR > 1.5 is generally considered to increase the     risk of bleeding. Furthermore, many authors consider platelets below 50 x 109 /l as a     contra-indication to CVC cannulation, since there are some data this may increase the risk of     bleeding. Therefore platelet transfusion before venous puncture is suggested. In our clinical     experience INR > 1.5 and platelets < 50 x 109 /l do not correlate with increased risk of     bleeding. The aim of this study is to demonstrate, that coagulopathy, defined by INR and     platelet count, is not decisive for bleeding.   "
198603|NCT00448201|"     RATIONALE: Giving low doses of chemotherapy, such as busulfan and fludarabine, before a donor     stem cell transplant helps stop the growth of cancer and abnormal cells. It also helps stop     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune cells and help destroy any remaining cancer or abnormal cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Immunosuppressive therapy may improve bone     marrow function and may be an effective treatment for hematologic cancer or other disease.      PURPOSE: This clinical trial is studying the side effects and how well giving busulfan and     fludarabine with or without antithymocyte globulin followed by donor stem cell transplant     works in treating patients with hematologic cancer or other disease.   "
198604|NCT00448214|"     To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial     fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics     (anti-thrombotic potential) in the target population   "
198605|NCT00448227|"     This study will evaluate the acceptability and safety of famciclovir in infants with herpes     simplex infection   "
198606|NCT00448240|"     The purpose of this study is to determine if combination Erlotinib, Cisplatin/Carboplatin,     and Paclitaxel are effective first line treatment for metastatic, recurrent and persistent     squamous cell carcinoma of the head and neck.   "
198607|NCT00448253|"     The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420     or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse     events and laboratory assessments. To determine the dose proportionality relation of three     different doses of NP-015.   "
198608|NCT00448266|"     This phase II/III trial will investigate the ability of chemotherapy with 'Intensified     Aklylating Agents (IAA) to achieve a high pathological complete response (pCR) rate when     employed in the preoperative chemotherapy of breast cancer with evidence of a Homologous     Recomination Deficiency (HRD).   "
198609|NCT00448279|"     This 2 arm study will compare the efficacy and safety of continuation or discontinuation of     Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive     metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus     Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment     (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line     chemotherapy of the investigator's choice. The anticipated time on study treatment is until     disease progression, and the target sample size is 100-500 individuals.   "
198610|NCT00448292|"     The purpose of this randomized, double-blind, placebo-controlled study is to assess the     safety and efficacy of PRX-00023 in patients with major depressive disorder.   "
198611|NCT00448305|"     The purpose of this study is to assess the efficacy, safety and tolerability of a therapy     with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for     patients with relapsed or metastatic triple receptor negative breast cancer (a special     subgroup of breast cancer).   "
198625|NCT00448487|"     3054 diabetic patients were screened for Haptoglobin Phenotype as part of the ICARE study     (NCT00220831) and composite the I CARE Registry, 1434 Hp 2-2 patients were treated as part of     the I CARE study with vitamin E vs. Placebo, this study was recently terminated due to     significant differences between the groups and data was sent to publication. All other     patients were passively followed since April 2005 for cardiovascular events. We have decided     to continue and follow these patients till end of December 2007 to determine the incidence of     CVD in theses patients which are pre stratified by Haptoglobin Phenotype.   "
198626|NCT00448500|"     This study aimed to assess airway inflammation in patients during the course of acute     exacerbations of chronic obstructive pulmonary disease (AECOPD) by serial analyses of their     exhaled breath condensates (EBC).   "
198612|NCT00448318|"     Dementing syndromes are, for the most part, incurable. People with dementia become highly     dependent and frequently have to move from their homes into residential aged care facilities.      Medications aimed at reducing the severity of a number of symptoms associated with the     different types of dementia have had only modest success.      Increasingly, people with dementia, their families and carers are turning to supplementary or     alternative approaches to the management of their symptoms. There are many published reports     describing the successful use of music therapy in reducing the severity of many symptoms of     dementia. These include reports of improved memory, improved language skills, reduced anxiety     and depression, reductions in agitation and disruptive behaviours and better social     relationships with family, peers and carers. However, the quality of evidence they provide     for the most part fails meet the standards of evidence required by health care providers.     This clinical trial will examine the effects of a music therapy intervention.      The study will recruit 180 patients in sub-acute hospital wards. Participants will be     randomly placed in groups that receive either occupational therapy or music therapy. Before     the therapy programs begin, we will use questionnaires to measure memory function, language     ability, orientation and mood. We will also record brain activity from the surface of the     scalp, blood pressure and pulse to examine physiological responses. The same measures will be     repeated after the 3 weeks of therapy to determine whether there has been any improvement in     the symptoms of the participants and whether the group that had music therapy showed greater     improvement than the group that had occupational therapy. We will make a video recording     during one therapy session to allow us to observe levels of engagement and to assess changes     in facial expressions. This will provide information about the immediate effects of music on     mood and social interaction. The information we collect about brain activity and blood     pressure will help us to understand how music therapy might bring about changes in the     symptoms of dementia. This understanding will be useful in developing better applications of     music therapy. It will also add to our current knowledge about how the various diseases cause     the problems they do.      In summary, the primary aim of the project is to determine whether the reported effects of     music therapy are supported by objective evidence.   "
198613|NCT00448331|"     The purpose of this study is to find out how prevalent unidentified Mental Health issues are     in the pediatric population that visits the Emergency Department in an urban city.   "
198892|NCT00443768|"     To identify patients within the community taking anti-parkinson medications in whom the     diagnosis of Parkinson's disease is incorrect and to supervise and clinically monitor the     withdrawal of anti-parkinson medications in this patient group   "
198615|NCT00448357|"     RATIONALE: Giving chemotherapy, such as fludarabine and busulfan, before a donor peripheral     stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop     the patient's immune system from rejecting the donor's stem cells. When the healthy stem     cells from a donor are infused into the patient they may help the patient's bone marrow make     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted     cells from a donor can make an immune response against the body's normal cells. Giving a     monoclonal antibody, alemtuzumab, before the transplant and tacrolimus after the transplant     may stop this from happening.      PURPOSE: The phase I portion of this trial identified the maximum tolerated dose of busulfan     after treating 40 patients on a dose-escalation scheme. We are now treating an additional 26     patients on the phase II portion of the trial at a Pharmacokinetic (PK)-directed dose of     total area under curve (AUC) 6912 micrometer (uM)-min/24 hours. We transitioned to the Phase     II portion of the study in October 2009.   "
198616|NCT00448370|"     The purpose of this research study is to find out whether Placenta Growth Factor (PlGF) and     related tests can predict the development of acute chest syndrome (ACS) in patients with     sickle cell disease (SCD) during a period where patients are well and during admission to the     hospital for an acute sickle event to see if these measures can predict the development of     ACS. Understanding events precipitating ACS may lead to preventative and interventional     therapies which will improve patient outcomes and quality of life.   "
198617|NCT00448383|"     This is an open-label, multi-center study in which adalimumab (D2E7) is administered     subcutaneously 40 mg every other week in addition to current anti-rheumatic therapies.     Patients must have active disease despite standard anti-rheumatic therapy.   "
198618|NCT00448396|"     To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with     advanced malignancies.   "
198619|NCT00448409|"     To evaluate the efficacy and safety of Trovax and GM-CSF in patients with prostate cancer.   "
198620|NCT00448422|"     The objective of this pivotal Phase III study is to investigate the safety and efficacy of     prulifloxacin versus placebo in the treatment of patients with acute bacterial     gastroenteritis (traveler's diarrhea.   "
198621|NCT00448435|"     To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison     with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus     fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma.      To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in     paediatric patients with asthma.   "
198622|NCT00448448|"     Adolescent idiopathic scoliosis (AIS) is a structural curve of the spine with no clear     underlying cause. Bracing is currently the standard of care for preventing curve progression     and treating AIS. However, the effectiveness of bracing remains unclear. The purpose of this     study is to compare the risk of curve progression in adolescents with AIS who wear a brace     versus those who do not and to determine whether there are reliable factors that can predict     the usefulness of bracing for a particular individual with AIS.   "
198623|NCT00448461|"     PROTOCOL SYNOPSIS Title: Comparison of bivalirudin and unfractioned heparin (UFH)+ protamine     in elective percutaneous coronary interventions (PCI)      Design: Prospective, randomized, controlled trial      Hypothesis: Bivalirudin is superior to UFH + protamine for the improvement of outcomes in     patients undergoing elective PCI      Key Inclusion Criteria:      Patients older than 18 years of age to undergo PCI Clopidogrel loading > 6 hrs prior to PCI     according to the PCI guidelines Informed, written consent      Key Exclusion Criteria:      ST-elevation myocardial infarction within the prior 48 hours Active bleeding, bleeding     diathesis, recent surgery Severe renal failure Chronic coronary artery occlusion to be     treated      Primary endpoint:      Inhospital major bleeding      Secondary endpoints:        1. Composite rate of death, myocardial infarction (MI) or target vessel revascularization          (TVR) inhospital, and at 6 months        2. Composite rate of inhospital death, MI or TVR and major bleeding        3. Major and minor bleedings        4. Total vascular complications        5. Post-procedure renal failure      Randomization:      Bivalirudin versus unfractioned heparin followed by protamine at the end of the PCI procedure      Sample size:      Assumed incidence of inhospital major bleeding of 6% in UFH + protamine and of 2% in     bivalirudin group; for a power of 80% and a level of 0.05 for each group 425 patients are     needed. An interim analysis will be performed after the enrolment of 425 (50%) patients.      Follow-up:      Inhospital, and 6-month clinical follow-up (out-patient clinic or by phone)   "
198624|NCT00448474|"     The purpose of this study is twofold, to develop and test the effectiveness of a mailed     arthritis self-management education intervention.   "
198628|NCT00448526|"     Diabetic nephropathy is the leading cause of chronic kidney disease all the world in spite of     progress in new treatment for diabetes and anti hypertensive drugs. Additional treatments are     thus needed to arrest the progression of diabetic nephropathy. Although there is insufficient     evidence to suggest that a low-protein diet improves renal dysfunction, it is recommended as     a mainstay of nutritional management. We here assessed the role of low protein diet in renal     function as well as albuminuria in type 2 diabetic patients with nephropathy for a median of     5 years.   "
199247|NCT00455585|"     This study aims to compare the steady state pharmacokinetics of stavudine, lamivudine, and     nevirapine in HIV positive Ugandan patients taking Triomune 40 with the pharmacokinetics of     the originator products known as Viramune, Epivir and Zerit 40.   "
198629|NCT00448539|"     This study is an open-label extension of Study E2080-A001-301. All patients will initiate the     study at the total daily doses they were receiving at the end of the transition phase in     E2080-A001-301 (2400 or 3200 mg/day) with an option, at the discretion of the Investigator,     to incrementally increase doses to a maximum of 4800 mg/day. Safety variables and seizure     frequency will be monitored throughout the study.   "
198630|NCT00448552|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving oxaliplatin together with     capecitabine works in treating patients with relapsed or metastatic head and neck cancer.   "
198631|NCT00448565|"     The evidence-based approach to wean and consecutively extubate patients is based solely on     objective criteria/tests. The introduction of subjective criteria could further improve the     actual method.   "
198632|NCT00448578|"     This is a randomised, double blind, double dummy, multicentre, parallel-group study to     compare the efficacy and safety of quetiapine and lithium used as monotherapy in the     treatment of mania in patients hospitalised for an acute manic episode. After given of     informed consent and undergoing screening procedures, the patients will be randomised into     quetiapine or lithium group on Day 1. The efficacy of study treatment on symptoms of mania     will be assessed at Day 28. Patients will not permitted to use any psychoactive or     antipsychotic medications throughout the study period other than those expressly permitted by     the protocol. The patients are required to be hospitalised for the treatment and assessment     defined in the protocol. He/She could be discharged from the hospital after Week 2 (i.e. On     Day 15) if the investigator believes that it will be clinical appropriate to discharge the     patient, that the patient is not suicidal or homicidal, and that the patient could reasonably     be expected to continue in the study on an outpatient basis. The patients discharged after     Day 15 will be given sufficient study medication for the period from discharge to the next     visit. At each centre, the same individual will administer a specific psychiatric assessment     for a patient at all study visits in order to reduce variability in rating scale scoring.     Before the initiation of the study, a consistency assessment will be done among the     investigators who conduct the scale assessment in each centre.   "
198633|NCT00448591|"     This single arm study will assess the safety and efficacy of a regimen of Avastin plus a     taxane, with or without additional chemotherapy, as first-line treatment in patients with     locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv     every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are     contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal     doxorubicin) may be used. The anticipated time on study treatment is until disease     progression, and the target sample size is 500+ individuals.   "
198634|NCT00448604|"     The objectives of the study are        -  to determine the prevalence of respiratory virus infections in COPD patients, during and          outside acute exacerbation        -  to explore the impact of these viral infections on the outcome of these patients        -  to explore the association between blood procalcitonin levels and viral infections in          this population.   "
198635|NCT00448617|"     This study will be a descriptive comparison of the effects of live attenuated influenza virus     (FluMist) on nasal inflammation and oxidative stress in healthy young adults who are not     exposed to smoke vs smokers. It is hypothesized that passive exposure to second-hand smoke     (SHS) results in increased susceptibility to the effects of influenza virus in nasal     epithelium in humans and that these effects are mediated by SHS-induced oxidative stress   "
198636|NCT00448630|"     The purpose of the study is to find and follow-up the metabolic syndrome parameters on     patients administering atypical antipsychotics.   "
198637|NCT00448643|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may also     make tumor cells more sensitive to cisplatin. Giving radiation therapy together with     cisplatin after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase I trial is studying the side effects and best dose of whole-abdominal     radiation therapy when given together with cisplatin in treating patients with stage III or     stage IV endometrial cancer that has been removed by surgery.   "
198638|NCT00448656|"     The purpose of this study is to determine the feasability of a new epicardial and minimal     invasive ablation technique of the left atrium isolating the pulmonary veins for prevention     of atrial fibrillation recurrences in patients with antiarrhythmic drug refractory lone     atrial fibrillation.   "
198639|NCT00448669|"     This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral     medicines) was safe for sexually-active young adults in Botswana without HIV infection and     whether it reduced their risk of getting an HIV infection.   "
198640|NCT00448682|"     RATIONALE: Drugs used in chemotherapy, such as floxuridine, leucovorin, oxaliplatin, and     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well combination chemotherapy works as     first-line therapy in treating patients with stage IV gastric cancer that cannot be removed     by surgery.   "
198641|NCT00448695|"     The objective of this study is to establish the safety of MRI targeted laser thermal     treatment for men with biopsy confirmed early stage low grade single sector prostate cancer.   "
198642|NCT00448708|"     This is a multi-center clinical study in subjects requiring arteriovenous grafts in the upper     extremity for hemodialysis access. All subjects will provide informed consent before     undergoing any study procedures. The study will consist of multiple subject visits and     telephone contacts during the 52 week study period. During the study period subjects must     also maintain an appropriate hemodialysis schedule.      IDE Number: G060250   "
198643|NCT00448721|"     This is a single-arm phase II trial of perifosine in renal cancer patients who have     experienced disease progression after receiving either sorafenib or sunitinib.   "
198644|NCT00448734|"     This study will review the safety of picoplatin, a new type of platinum drug, with docetaxel,     a drug commonly used in the treatment of prostate cancer. Patients who are eligible for this     study will have had a diagnosis of hormone-refractory prostate cancer that has metastasized     to other areas of the body, and have not been previously treated with chemotherapy drugs.     Picoplatin will be administered in combination with docetaxel and prednisone to identify the     maximum tolerated dose (MTD). Patients will receive IV treatments of picoplatin with     docetaxel every 3 weeks, with prednisone, 5 mg orally, twice daily.   "
198645|NCT00448747|"     The diagnosis of GH deficiency (GHD) in adults is established by laboratory testing in     patients with an appropriate clinical history of hypothalamic pituitary disease. Two tests     that are considered to be gold standard tests for the diagnosis of GHD are the insulin     tolerance test (ITT) and GHRH combined with arginine. However, these tests are either     bothersome (given intravenously) to the patient or are linked with side effects. Therefore,     an orally available compound like AEZS-130(formerly ARD-07), if demonstrated to be safe and     providing adequate sensitivity and specificity could be a welcome alternative and/or     complement to the current available tests.      The intent was to recruit 40 AGHD patients and 40 normal control subjects into this trial,     but the original sponsor (Ardana Biosciences Ltd.) discontinued the study for financial     reasons before this was completed. At the time of withdrawal of GHRH from the market in 2008,     42 AGHD patients and 10 normal controls had completed the study at 9 US sites. This study is     now being reactivated to complete the remaining 30 matched control subjects.      Additionally upon agreement with the FDA in a SPA, 10 additional adult grown hormone     deficient and their matched control will be enrolled into this trial for a total treated     population approximatively 100 subjects.   "
198646|NCT00448760|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, and     leucovorin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating     patients with previously untreated stage II or stage III esophageal cancer that can be     removed by surgery.   "
198647|NCT00448773|"     We will be testing the hypothesis whether online education for UC Berkeley students on     respiratory hygiene, cough etiquette, hand hygiene/awareness, as well as face mask use (while     ill) will reduce the acquisition and transmission of influenza-like illness. The study will     be conducted during the flu seasons 2006-7 and 2007-8.   "
198648|NCT00448786|"     The study involves the use of three different dosing regimens of AMG 706 in patients with     advanced solid tumors to see how the drug affects the gallbladder size and function. The     study will be conducted in 11 sites in the US and Australia. A total of 48 patients will be     enrolled in the study with the possibility of enrolling 8 more in each treatment arm.   "
198649|NCT00448799|"     The underlying goal of this study is to assess 123-I AV83 SPECT imaging as a tool to detect     ß-amyloid deposition in the brain of AD research participants and age- and gender-matched     healthy subjects.   "
198650|NCT00448825|"     The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral     Therapy for the treatment of alcohol and cocaine dependence.   "
198651|NCT00448838|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth     of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as     gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving cetuximab together with     combination chemotherapy may kill more tumor cells.      PURPOSE: This clinical trial is studying how well giving cetuximab together with gemcitabine     and oxaliplatin works in treating patients with locally advanced or metastatic pancreatic     cancer.   "
198652|NCT00448851|"     The purpose of this research study is to learn more about the effect of inhaled dust mite     allergen extract on airway responses in allergic individuals with mild asthma. Information     learned from this study will be used to identify a safe dose range of D Farinae extract for     use in inhalation challenge studies. This study will also help determine how inhalation of     the allergen affects mucociliary clearance (MCC) which is a measure of how quickly mucus     clears from the airway.   "
198653|NCT00448864|"     The primary objective of this study was to assess the efficacy and safety of 2 dose levels of     ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as     measured by chest tube drainage during the first 12 hours postoperatively or until the chest     tube was removed, whichever came first, in patients undergoing primary coronary artery bypass     grafting (CABG), single valve repair, or single valve replacement.      The secondary objective was to compare the efficacy of all ecallantide-treated participants     (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose     ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody     formation.   "
198654|NCT00448877|"     The purpose of this study is to determine whether or not a new brain function monitor can     distinguish between anesthetized and awake patients. The device implemented utilizes     functional near-infrared (fNIR) technology to detect anesthesia depth as well as reaction to     stimuli during surgical procedure.      After obtaining consent the device is placed across the forehead of the patient. A baseline     signal is obtained prior to induction. The fNIR signal is continuously recorded throughout     the procedure. Key events as well as administration of drug are recorded in order to observe     changes in the signal trend. Neither the device nor the light emitted is hazardous to the     patient - no risks or discomforts are involved.   "
198655|NCT00448890|"     GSK729327 is a selective positive allosteric modulator of AMPA-type ionotropic glutamate     receptors, exhibiting equivalent potency at all AMPA receptor subtypes. On the basis of     preclinical studies it is expected that this compound will improve cognitive measures in     schizophrenic patients with acceptable safety. This is a First Time in Human Study (FTIH) to     assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of     GSK729327 in healthy volunteers. The study will be conducted in 2 parts, with single doses     being explored in Part A and multiple doses over 28 days in Part B. Part A will be a single     blind, placebo controlled, single oral dose, dose-rising cross-over study in healthy male     volunteers. Subjects will be randomized into two cohorts with an alternate panel design.     There will be up to nine dosing sessions in total in order to investigate up to 7 different     doses. The initial dose will be 0.25 mg and subsequent doses will be determined based on the     pharmacokinetic and safety results from the previous dose. Part B will be a randomised,     single blind, placebo-controlled, parallel group study of repeat oral dosing of GSK729327. Up     to 4 cohorts of 15 (12 subjects receiving active dose and 3 subjects receiving placebo)     healthy male and females of (non-childbearing potential) volunteers will be enrolled in Part     B.   "
198656|NCT00448903|"     Chronic foot ulcers are a common, severe and expensive complication in patients with diabetes     and often causes lower-extremity amputation. The aim of this study is to evaluate the effect     of bemiparin as treatment of diabetic foot ulcers.   "
198657|NCT00448916|"     The study will evaluate the long-term safety and tolerability of pregabalin in pediatric     patients, age 1 month through 16 years, with partial onset seizures.   "
198658|NCT00448929|"     The purpose of this study is to compare the safety and effectiveness of trabeculectomy with     ologen (OculusGen) Biodegradable Collagen Matrix Implant and trabeculectomy without     antifibrotic agents.   "
198659|NCT00448942|"     The purpose of this study was to determine if the use of daily chlorhexidine bathing would     decrease the incidence of MRSA and VRE colonization and healthcare associated Bloodstream     Infections (BSI) among Intensive Care Unit (ICU) patients.   "
198660|NCT00448955|"     Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in     clinical practice and has significant effects on patient wellbeing. The purpose of this study     is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy     in testosterone deficient men.   "
198661|NCT00448968|"     The purpose of this study is to determine if levels of ischemia modified albumin (IMA) in     blood are elevated in patients with suspected infection and are predictive of severity of     illness in patients with sepsis.      In order to compare subjects with infection to those without infection who are representative     of the ED population at each site, a group of non-infected control patients will be enrolled.     Each hospital will enroll subjects with age (by decade) and sex matched controls to reflect     the population of subjects suspected of infection.   "
198662|NCT00448981|"     Colds and flu cause much loss of work and school. The purpose of this study is to try to     reduce the transmission of colds and flu among household members with one of three     interventions: some educational material, educational material and use of alcohol hand     sanitizers, and educational material and use of alcohol hand sanitizers as well as face masks     when somebody has symptoms of the flu. We will recruit 450 households in Northern Manhattan     and each household will be randomly assigned to one of these three groups. We will then     follow these households for 15 months to see how often they get cold and flu symptoms. We     will also look at antibiotic use practices for symptoms of colds and influenza ; household     member knowledge of prevention and treatment strategies for pandemic influenza and viral     URIs; and rates of influenza vaccination among household members. When someone in the study     has serious flu symptoms such as a high fever and cough or sore throat, we will also obtain a     nasal culture (by swabbing the nose) to see if there is flu virus present.   "
198663|NCT00448994|"     This study is designed to determine the rate at which stem cell transplant patients can     develop infection caused by a group of viruses, known as adenovirus, and common fungi. Stem     cells are unspecialized cells, capable of producing more stem cells or other specialized     cells, and are used to replace damaged or diseased cells. The study will be conducted in     children (2-17years old) being transplanted with stem cells from a donor. Patients undergoing     stem cell transplantation are more likely to develop infections as their immune systems are     weakened. Blood, stool, urine and throat swab samples will be collected (for at least 100     days on a weekly basis) to detect infection(s) caused by adenovirus or fungus. Subjects will     participate for up to 1 year following the transplant procedure.   "
198664|NCT00449007|"     We will study patients with a current major depressive episode, comorbid alcoholism and a     history of a past suicide attempt. All subjects with alcohol dependence will be evaluated for     risk of alcohol withdrawal prior to randomization. The study will provide six months of     antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse     prevention. Patients will also be encouraged to attend daily Alcoholics Anonymous meetings.     The outcome measures will be: 1) occurrence of suicide events; 2) reduction of suicidal     ideation; 3) reduction in neuropsychological measures of impulsivity.   "
198665|NCT00449020|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, irinotecan, and docetaxel, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     combination chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving carboplatin and irinotecan together     with radiation therapy followed by docetaxel works in treating patients with newly diagnosed     stage III non-small cell lung cancer.   "
198666|NCT00449033|"     Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for     the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)   "
198667|NCT00449046|"     This study evaluates the long-term (24-week) safety and efficacy of GW815SF     Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of     25/50mcg) bid in pediatric patients with bronchial asthma.   "
198668|NCT00449059|"     The aim of the study was to evaluate the acute effect of nitroglycerine infusion on blood     pressure and heart rate in heart-transplanted patients with cyclosporine-induced     hypertension.   "
198669|NCT00449072|"     The primary objective of the study was to characterize the difference in prepubescent growth     velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with     triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo     (NASACORT® AQ placebo group) for 12-months.      The secondary objectives were to compare the following in prepubertal participants treated     with TAA nasal spray versus placebo:        -  the 24-hour urinary free cortisol levels and the cortisol/creatinine ratio (to measure          the Hypothalamic-Pituitary Adrenal [HPA] axis function)        -  the rate of treatment-emergent-adverse-events (TEAE)        -  global efficacy rated by the investigator and the participant separately        -  the rate of use of rescue medication during the study   "
198670|NCT00449085|"     Feasibility study to evaluate CARTO™ XP EP Navigation System V9 and SOUNDSTAR 3D Diagnostic     Ultrasound Catheter.   "
198671|NCT00449098|"     The purpose of this study is to compare the safety and effectiveness of the ologen     (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.   "
198672|NCT00449111|"     Evaluate blood pressure after 6 weeks of treatment with COZAAR plus.   "
198673|NCT00449124|"     The purpose of this study is to evaluate the safety and effectiveness of an investigational     vaccine (TG4040) to prevent hepatitis C virus (HCV) infection. The primary goal of this study     is to determine the safety of increasing doses of TG4040 versus placebo (an inactive     substance) in subjects chronically infected with HCV. Approximately 85 patients, ages 18-65     years, with chronic HCV infection will be enrolled in this study at two sites, Saint Louis     University and Cincinnati Children's Hospital. Volunteers will receive doses of TG4040 and     placebo by injections into the thigh on different days, depending on which study group they     belong to. Safety will be checked before doses are increased, and each participant will     receive the study vaccine, TG4040, at some point during the study. Each subject will     participate in the study for 8 months. This study may help produce a new vaccine that would     improve control of HCV.   "
198674|NCT00449137|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Arsenic trioxide may help fluorouracil and leucovorin work better by making tumor     cells more sensitive to the drugs. Giving arsenic trioxide together with fluorouracil and     leucovorin may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide     and fluorouracil when given together with leucovorin in treating patients with stage IV     colorectal cancer that has relapsed or not responded to treatment.   "
198675|NCT00449150|"     Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is     characterized by an enlargement of the prostate occurring in human male over the age of 50     which increases in prevalence with age, and among those aged 50 to 80, about 40% report     moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve     patients' quality of life which primarily depends on the severity of the symptoms of BPH.     Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.      For this study, study medication (Cetrorelix pamoate or placebo)is administered by injection     in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to     52) are eligible to receive the active drug during the open-label part of the study (Week 52     to 90).   "
198676|NCT00449163|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab     may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving     combination chemotherapy together with bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with bevacizumab works in treating patients with stage IV colorectal cancer.   "
198677|NCT00449176|"     The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety     of orally administrated tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250     mg twice daily in patients with moderate to severe chronic pain of the lower back, in     comparison with placebo and Oxycodone Controlled Release (CR).   "
198678|NCT00449202|"     The purpose of this study is to evaluate the safety, preliminary efficacy, and     pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult     subjects.   "
198679|NCT00449215|"     The genetic bases of peak bone mass in males, as determinants of an individual’s risk of     developing osteoporotic fractures in old age and their interaction with dietary and lifestyle     factors are still poorly understood.      Our objective was to examine the relative contribution of genetic and environmental variables     to the regulation of peak bone mass in a population-based cohort of young healthy men,     focusing on the BsmI polymorphism of vitamin D receptor (VDR)gene and the AluI polymorphism     of calcitonin receptor (CTR)gene.   "
198680|NCT00449228|"     We propose to evaluate a preoperative education of the patient and a new surgical technique     (the mini-invasive THR) that could reduce the time to achieve functional independence.      The primary objective of the trial is to assess the time to reach functional independence     after total hip replacement depending on the treatment groups: preoperative education versus     no preoperative education and mini-invasive procedure versus standard procedure. The study     hypothesis is that education and mini-invasive procedure will reduce the time to reach     functional independence.      This is a prospective trial with a double randomization.   "
198681|NCT00449241|"     To find out how the application of acupuncture needles to the proposed acupuncture points:     Heart 7 (HT 7) and Pericardium 6 (PC 6) for reducing anxiety during     Esophago-gastro-duodenoscopy (EGD)   "
198682|NCT00449254|"     Multi-center, multiple-dose, randomized, double-blind, three-arm, placebo-controlled study of     fixed-dose repeated oral dosing for 30 days of 10 mg and 30 mg MP-101 and placebo in obese     subjects.   "
198683|NCT00449267|"     The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured     by aurolab are safe and effective in the surgical treatment of cataract.   "
198686|NCT00449306|"     Lipid-rich atherosclerotic plaques, or vulnerable plaques are prone to rupture, causing     local intravascular thrombosis, with subsequent grave clinical consequences. Atherosclerotic     plaques normally removed during surgery, and peripheral blood samples will be studied to     achieve the following objectives:      1 Define histological features of the vulnerable plaque, analyze its physical     characteristics, and investigate selected gene expression.      2 Study biomarkers of inflammation in conjunction with the presence of vulnerable plaques.      3 Explore the potential role of infection in atherogenesis.   "
198687|NCT00449319|"     The present therapy intends to be an homogeneous treatment for AML patients based on a     pretreatment with hydroxiurea plus an induction therapy with the standard arm with     Daunorubicine as according to EORTC-GIMEMA AML10 study.      The post-remissional treatment is based on transplant with HLA compatible donor is foreseen     for all patients and autologous transplant for those without HLA compatible donor available.   "
198688|NCT00449332|"     The purpose of this research is to discover the different patterns of cytokine production in     patients who may develop Bronchiolitis Obliterans Syndrome-0p (BOS-0p) which means ongoing     rejection. This is an early indicator of chronic rejection in lung transplant recipients.     These cytokines can be detected in the bronchoalveolar (lung) and tissue samples of lung     transplant recipients.   "
198689|NCT00449345|"     The ministry of health in Israel requires all health-care workers to undergo screening for     latent Tuberculosis infection (LTBI) prior to starting work. This is based on the Mantoux     skin test, which is notoriously unreliable.      In recent years, more specific and sensitive tests based on interferon-gamma secretion to TB     antigens have come to market, and most current evidence shows that many mantoux positive     persons do not have LTBI. Quantiferon-GOLD is one of these assays.      In this prospective study, we will draw blood for the Quantiferon-GOLD assay in parallel to     conventional testing, and perform a cost-effectiveness analysis of the cost of the     investigation and treatment of LTBI in health-care workers.      We hypothesize that in spite of the cost of screening healthcare workers with     Quantiferon-GOLD tests, the reduction in need for LTBI treatment and associated costs will     render the test cost-effective.   "
198690|NCT00449358|"     Correlation between Mohs surgery and microscopic fluorescence photometry in determination of     histological borders in Basal Cell Carcinoma .   "
198691|NCT00449384|"     The purpose of this study is to validate and to test interrater reliability for the Norwgian     version of Severe Impairment Battery (SIB).   "
198692|NCT00449397|"     The purpose of this study is determine the minimal effective dose and the impact on:        1. treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients          experiencing the first psychotic episode        2. the final maintenance doses        3. the use of other medications        4. the amount of changes to other antipsychotic medication        5. the number of hospitalization days   "
198693|NCT00449410|"     In elderly patients with atrial fibrillation (AF) the presence of silent brain infarcts and     neurocognitive deficit is high despite adequate treatment with oral anticoagulation.     Atherosclerosis is considered to be a chronic inflammatory disease and thrombosis and     inflammation are strongly correlated. Atrial fibrillation is linked with increased levels of     inflammatory markers and intensive cholesterol lowering has proven to reduce inflammation. In     a prospective double-blind randomized pilot-study we want to test the hypothesis, that     addition of intensive cholesterol lowering treatment besides adequate oral anticoagulation     will reduce cerebrovascular lesions and will be beneficial for neurocognitive status in     elderly AF patients.   "
198694|NCT00449423|"     The primary objective of this study is to evaluate whether metabolic modulation improves     hemodynamics and outcome in acute heart failure   "
198695|NCT00449436|"     The current goal of antiretroviral therapy is to use a potent regimen that will suppress     plasma viral load and maintain this suppression as long as possible. However, for most     patients treated with such potent regimen, several problems can limit their long term     effectiveness and contribute to incomplete viral suppression. These problems include poor     tolerability, metabolic toxic effects. In order to avoid common problems as toxicity it might     be interested to simplify treatment with fewer toxicity, lower pill burden. In this study we     will evaluate the safety and efficacy of a simplification treatment with TRIZIVIR in long     term after a Boosted PI or NNRTI containing regimen as first line therapy.   "
198696|NCT00449449|"     The study tested the hypothesis that a pertubation with a lidocain solution will enhance     pregnancy rate.   "
198697|NCT00449462|"     The knowledge of the health effects of CLA on the human body is limited. However, CLA     supplements are sold over the counter in several countries and various techniques are used to     increase the content of CLA in food.      The CLAxon-study will be performed to investigate wether high doses of CLA can be safely     given to healthy human volunteers.   "
198698|NCT00449488|"     The primary objective of this study is to establish the effects of a single bolus of EPO,     administered within three hours after a primary PCI for a first acute myocardial infarction,     on left ventricular function.   "
198699|NCT00449501|"     The purpose of this study is to demonstrate whether subjects respond similarly to the Onset     of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving     SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2     actuations twice daily.   "
198700|NCT00449514|"     About 10-15% of all couples attempting to conceive will not become pregnant within one year.     Among those, the majority will have ovulatory dysfunction, mild male infertility or     unexplained infertility. The traditional first line therapy for those couples is ovulation     induction or superovulation using clomiphene citrate. Probably due to anti-estrogenic effects     of this agent will, some patients will have a thin endometrium as measured by sonography at     the time of ovulation. This phenomenon may be associated with a lower chance to conceive.     Tamoxifen is a similar molecule that has been used to clomiphene citrate that has been shown     to be equally effective to clomiphene in ovulation induction. Preliminary observations showed     that tamoxifen does not cause a negative effect on the endometrium as compared with     clomiphene, and may increase the chance to conceive in those patients who have a thin     endometrium under clomiphene.   "
198701|NCT00449527|"     The purpose of this study is to demonstrate whether subjects respond similarly to the Onset     of Effect Questionnaire (OEQ) using a 1 week recall period versus a 1 day recall period.   "
198702|NCT00449540|"     Assess safety and efficacy of Transcranial Magnetic Stimulation (TMS) for the treatment of     migraine with aura      The hypothesis is that TMS treatments delivered to the occipital cortex of the brain can stop     or interrupt the spreading cortical brain activity that causes or contributes to the migraine     headache. Two TMS treatments at an intensity of <1 Tesla for ~500 microseconds, approximately     30 seconds apart, may stop the aura and prevent the subsequent headache.   "
198703|NCT00449553|"     The purpose of this study is to asses changes in glycosylated hemoglobin, fasting blood     lipids and genetic polymorphism's in peroxisomal proliferator activated receptors--gamma     receptor after 6 months of pioglitazone, once daily (QD), treatment.   "
198704|NCT00449566|"     The purpose of this study is to investigate brain development in autism by longitudinally     assessing children with autism, as well as typically developing controls, using advanced MR     techniques. We will use longitudinal diffusion tensor imaging (DTI) measures to investigate     the protracted development of long-range white matter fibers in autism. In addition, we will     investigate the effect of autism risk genes on brain development.   "
198705|NCT00449579|"     The main objective of this study is to determine the usefulness of the HyperQ™ System in     improving the positive predictive value of conventional ECG stress testing.      Patients who are referred for stress test will perform an ECG stress test on a treadmill,     with high-frequency ECG recording from conventional 12 leads using BSP's HyperQ™ System.     Conventional 12 lead ECG, as well as HyperQ™ recordings will be provided by the HyperQ™     System. The results of the conventional test and the HyperQ™ data will be compared, using one     of three cardiac tests (stress echocardiography, SPECT myocardial perfusion imaging and     angiography) as gold standards.      Statistical analysis will compare the sensitivity, specificity, PPV and NPV of the     conventional and HyperQ™ stress ECG in detecting myocardial ischemia.   "
198706|NCT00449592|"     Zinc is an intracellular mineral with important enzymatic cofactor activities for cell     membrane stability, DNA and RNA structure. Zinc deficiency is associated with delayed wound     healing and immune dysfunction. In patietns with hematological malignancies an inverse     correlation was found between disease stage and zinc level. Patients undergoing high dose     chemotherapy for hematologic malignancies are predisposed to develop oral and     gastrointestinal complications, in particular oral mucositis. These patients may have     relative zinc deficiency, therefore oral zinc therapy may be benefical in the prevention of     these complications.   "
198707|NCT00449605|"     The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of     rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin     (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with     metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.      The main secondary objectives are to assess the effect of rimonabant in comparison with     glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of     rimonabant in comparison with glimepiride.   "
198708|NCT00449618|"     Aspirin (ASA) has been shown to provide marked benefits in the prevention of cardiovascular     events, although the potential direct effects of ASA on cardiovascular function remain     uncertain. Previous studies have demonstrated that ASA is a potent antioxidative agent that     markedly reduces vascular production of superoxide in normotensive and hypertensive rats. In     addition, ASA was found to prevent angiotensin II-induced hypertension and cardiovascular     hypertrophy, mainly through its antioxidative properties in preventing the generation of     superoxide, although ASA apparently did not appear to reduce hypertensive levels of blood     pressure (BP). Moreover, recent results have demonstrated that ASA induces nitric oxide (NO)     release from vascular endothelium. No attention has been paid, so far, to potential     administration time-dependent effects in these studies.      Previous laboratory animal and clinical trial research convincingly demonstrates     administration time-dependent (with reference to circadian rhythms) effects of ASA. Thus, the     effects of ASA upon lipoperoxides, β-adrenergic receptors, and BP in clinically healthy     subjects depend on the circadian timing of ASA administration. Most important, the     administration time-dependent influence of ASA on BP was previously demonstrated in a     randomized trial on healthy women and in other independent, double-blind, randomized,     placebo-controlled clinical trials. The first was conducted on clinically healthy subjects, a     second one on normotensive and hypertensive subjects, a third one on pregnant women at high     risk for preeclampsia and a fourth one in previously untreated patients with mild     hypertension. The findings of these BP studies are consistent; the BP-lowering effect of     low-dose ASA is achieved when administered at bedtime but not upon awakening.      In keeping with the chronopharmacological effects of ASA and the previous findings suggesting     that ASA at low dose may have a potential beneficial effect on BP, this prospective,     randomized, double-blind, crossover study will investigate the potential influence of ASA on     BP in subjects with either high-normal BP or diagnosis of mild (grade 1) hypertension. The     subjects will receive low-dose ASA or placebo at different times of the day according to     their rest-activity cycle, and will be evaluated by 48-hour ambulatory BP monitoring before     and after 6 weeks of pharmacologic intervention.   "
198709|NCT00449631|"     We investigate whether mitomycin C treatment during previous filtration surgery induces     P-glycoprotein expression.   "
198710|NCT00449644|"     The objective of this study is to demonstrate that the antibacterial activity of TMC207 is     better than placebo when added to a standardized Background Regimen (BR) for treatment of     multi-drug resistant TB. Also safety and tolerability will be evaluated.   "
198711|NCT00449657|"     This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel     with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA     and IIIB non-small cell lung cancer   "
198712|NCT00449670|"     The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a     GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults     aged between 18 and 60 years.   "
198713|NCT00449683|"     The study consists of measurement of antidepressant-induced excessive sweating and its     treatment with an experimental medication, terazosin (approved for hypertension), that will     be added to the antidepressant. This study is for people who take an antidepressant due to a     depressive disorder. This is an open-label study (no placebo group) that will last 5 weeks,     with one week of baseline measurement and four weeks of treatment with the study medication.     The study is based on the hypothesis that terazosin will be effective in reducing the     severity of excessive sweating caused by antidepressant treatment, and will have minimal     side-effects.   "
198714|NCT00449696|"     The purpose of this study is to determine if a single intra-articular injection of Gel-200 is     superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with     symptomatic osteoarthritis of the knee.   "
198715|NCT00449709|"     PreTerm Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity     and mortality and is frequently associated with long-term disability. Oxytocin is a hormone     produced by the body during labor. GSK221149 is an experimental drug that will be used to     block the effects of oxytocin, and therefore pause or prevent contractions. In this study,     the pharmacokinetics of various modified release formulations of GSK221149 will be     investigated in healthy non-pregnant adult subjects.   "
198717|NCT00449735|"     This proposed study aims to document the risk factors for quinolone resistance in bloodstream     isolates of E. coli. Additionally, the adequacy of empiric antibiotic therapy for E. coli     bloodstream infections will be assessed. Finally, outcome will be recorded - this is     all-cause mortality at 28 days from the time of the first positive blood culture. Hypothesis:     Ciprofloxacin resistant strains are associated with admission from nursing home and with     prior quinolone use.   "
198718|NCT00449748|"     The goal of this clinical research study is to see if RAD001 can help to control the disease     in patients with systemic mastocytosis (SM). The safety of this treatment will also be     studied.   "
198719|NCT00449761|"     This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic     myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant     disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors   "
198720|NCT00449774|"     This study intends to demonstrate bioequivalence of two formulations, the effect of food and     water on one formulation and safety and tolerability of two formulations of lamotrigine in     healthy male and female volunteers   "
198721|NCT00449787|"     2/3 of patients discharged from an emergency department after treatment for an acute headache     will still be bothered by headache within 24 hours of emergency department (ED) treatment.     The goal of this study is to compare two medications, naproxen and sumatriptan, to determine     which is better for the treatment of recurrent headache within 24 hours of emergency     department discharge.   "
198722|NCT00449800|"     Ceftriaxone pharmacokinetics variability in intensive care unit septic patients      In intensive care units, drug dosage is often based on study made on healthy volunteers or on     less severe patients.      However, pharmacokinetic alterations have been described for some drugs used in intensive     care units.      These alterations, consequences of alteration of volume of distribution, of protein     concentrations, of impaired hepatic and renal functions can result in accumulation with     toxicity or « under dosage » with inefficacity.      Ceftriaxone is an antibiotic often prescribed in intensive care unit. However, despite this     large utilisation, very few data is available on the pharmacokinetic in intensive care unit,     and optimal dosage is not known.      Our objective is to develop a population pharmacokinetics model of ceftriaxone in intensive     care unit patients with sepsis, severe sepsis and septic shock and to identify the « data »     explaining interindividual variability of each pharmacokinetics parameter.   "
198723|NCT00449813|"     The aim of the study is to compare two different endpoint measures: heartburn as assessed by     the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by     the patient using the ReQuest™ questionnaire. The assessment is made in GERD-patients treated     with a daily dose of 40 mg oral pantoprazole over an 8-week period.   "
198724|NCT00449826|"     The purpose of this project is to examine the effectiveness of computed tomographic     angiography (CTA) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).     People who are hospitalized with this situation often require an angiogram to assess the     heart and its arteries.      Recent advancements in technology have enabled CTA to clearly define coronary artery anatomy     with great accuracy and to guide treatment strategies in select patient populations. We are     investigating that CTA may be used, as an alternative to conventional angiograms, for the     risk stratification of patients with high risk NSTE-ACS.      Patients eligible for the study will be high risk NSTE-ACS and awaiting an angiogram.     Enrolled patients will undergo CTA prior to the angiogram. With each CTA the patient will be     injected with a small dose of an X-ray dye and will be asked to lie still on the scanning     bed for a period of 5-10 minutes.   "
198725|NCT00449839|"     A pharmacokinetic study of insulin pump treatment using Insulin Aspart. The study consist of     three different periods A, B and C where a constant the insulin infusion rate is given during     the periods. In period B and C will the infusion start with a bolus.      It will be investigated if a steady state of insulin will be obtained faster in period B and     C then A.   "
198726|NCT00449852|"     A randomized control trial is planned to evaluate an interactive voice response (IVR)     mediated follow-up and triage system, against usual care, to help smokers hospitalized with     Coronary Heart Disease (CHD) to quit smoking. The investigators hypothesize that compared to     usual care, participants in the IVR group will; a) have a significantly higher 7-day point     prevalence abstinence rate at 26 and 52 weeks after hospital discharge, b) will have a higher     rate of continuous abstinence at 26 and 52 weeks after hospital discharge, c) will use a     greater number of proven effective interventions over time, and d) will develop greater     self-efficacy with respect to smoking cessation, over time.   "
198727|NCT00449865|"     The purpose of this trial is to determine if the nutritional supplement creatine slows the     progression of Parkinson's disease over time.   "
198728|NCT00449878|"     This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic     fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).   "
198729|NCT00449891|"     This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning,     behavior and development in young children and whether there are associated changes on their     MRI scan.   "
198730|NCT00449904|"     This is an open-label, single-arm clinical study investigating the long-term safety of     ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic     insufficiency (PI).   "
198731|NCT00449917|"     The purpose of this study is to determine the benefits of Visiobiane Anti-age dietary     supplement on macular pigment optical density, contrast sensibility and visual acuity.     Additionally, the study would like to evaluate seric variations of carotenoids and the total     antioxydant capacity.   "
198732|NCT00449930|"     A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used     medication in patients with type 2 diabetes   "
198765|NCT00442117|"     This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder     Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder     Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated     with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate     persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks.     The primary efficacy endpoint is percent change from baseline in FEV1.   "
198733|NCT00449943|"     Cardiovascular disease and ischemic heart disease is the #1 killer in Canada. Currently,     Cardiac invasive catheterization angiography (CICA) is the gold standard for the assessment     of the arteries in the heart. However, cardiac catheterization has risks which prohibit its     use in all patients. These risks include: death, heart attack, stroke and bleeding. Cardiac     computed tomography angiography (CTA) is a new non-invasive technology which may enable the     evaluation of patients' coronary anatomy without exposing patients to the risks of invasive     cardiac catheterization.      The purpose of this project is to compare CT angiography (CTA) to Tc-99m single photon     emission computed tomography (Tc-99m SPECT)      We will enroll patients who are waiting for a CICA or who have been referred for a TC-99m     SPECT or CTA scans at the University of Ottawa Heart Institute. Consenting patients who are     waiting for a CICA will have both a CTA and a Tc-99m SPECT scan. Consenting patients referred     for a CTA or Tc-99m SPECT will have both the CTA and Tc-99m SPECT in a random order but not     CICA (unless ordered by your physician).   "
198734|NCT00449956|"     The clinical study compares safety and efficacy of MK0507A (dorzolamide 1.0% / timolol 0.5%)     with 1) timolol 0.5% and with 2) concomitant therapy with dorzolamide 1.0% / timolol 0.5% in     patients with glaucoma and ocular hypertension.   "
198735|NCT00449969|"     The purpose of this study is to determine whether an online automatic feedback improved CPR     quality (No-flow time, compression depth, short-term survival and one year follow up) in this     prospective randomised study of out-of-hospital cardiac arrest   "
198736|NCT00449982|"     The purpose of this study is to investigate the clinical efficacy, safety and tolerability of     a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external     genitial warts in male and female patients.   "
198737|NCT00449995|"     Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The     ideal situation for the endoscopist is to visualize cellular structures, which implies having     microscopic imaging available. A potential candidate to fill this gap could be confocal     fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold     standard with the confocal fluorescence microscopy for detection of metaplastic - or     intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has     been initiated.   "
198738|NCT00450008|"     The purpose of this study is to assess the relative efficacy and toxicity of combination     therapy of GM-CSF, Thalidomide plus Docetaxel in patients with prostate cancer with a rising     PSA.   "
198739|NCT00450021|"     This study will test a new radioactive tracer, [(11)C]MePPEP, for use in positron emission     tomography (PET) imaging. The tracer is used to visualize cannabinoid receptors, proteins in     the brain that mediate a variety of natural chemicals. These receptors may be important in     behavioral diseases such as addiction, obesity and psychiatric diseases.      Healthy normal volunteers between 18 and 65 years of age may be eligible for this study.      Ten participants undergo whole body PET imaging to determine where the [(11)C]MePPEP tracer     is distributed in the body in order to calculate radiation exposure from the tracer. Another     10 subjects undergo brain imaging with [(11)C]MePPEP to measure cannabinoid receptors in the     brain.      All participants are evaluated with a medical history and physical examination, blood and     urine tests and an electrocardiogram (ECG) before scanning. They then have a PET scan. For     this procedure, a catheter (plastic tube) is placed in a vein in the arm through which the     tracer is injected. A special mask is fitted to the head and attached to the bed to help keep     the head in place during the scan. Subjects undergoing brain imaging also have a catheter     placed in an artery in the wrist from which blood samples are collected during the procedure.     The scan lasts about 2 to 2.5 hours.      Subjects undergoing brain imaging also have magnetic resonance imaging (MRI) within 1 year of     the PET scan. For MRI, the subject lies on a bed that moves into the tubular scanner, wearing     earplugs to protect the ears from loud noises that occur during the scan. The procedure takes     about 1 hour.   "
198740|NCT00450034|"     A randomized trial has been designed to determine if this complex intervention can     significantly decrease the risk of unplanned readmissions in this very elderly population,     compared with usual care.   "
198741|NCT00450047|"     The purpose of this study is to verify the efficacy of speed-feedback therapy in improving     the cognitive function of elderly people with dementia by a randomized controlled trial, and     to demonstrate how that affects ADL and QOL.   "
198742|NCT00450060|"     The purpose of this study is to compare postlumbar puncture complaints as headache or     backache after lumbar puncture with needles with Quincke design or with Sprotte design in     children and adolescents.   "
198743|NCT00441831|"     Helicobacter pylori (HP) is a gram-negative bacillus responsible for one of the most common     infections found in humans worldwide. By the early-to-mid 1990s, further evidence emerged     supporting the link between the chronic gastritis of HP infection and malignancy in adults,     specifically gastric lymphoma and adenocarcinoma. The potential of HP eradication for the     prevention of gastric cancer was underlined. At the national consensus meeting held in     Brussels in 1998, HP eradication was strongly recommended in past or current peptic ulcer     diseases, regardless of activity, complication and post endoscopic resection of early cancer.     Some patients received gastric surgery due to the complications of peptic ulcer such as     bleeding or perforation in the pre-HP eradication era. Their HP infection status was not     surveyed and unknown at the time. Afterward, some of them were not suggested to receive an     eradication therapy and recovered from the operative procedure. According to the consensus to     treat HP for a purpose to reduce the risk of gastric cancer, these patients were still under     risk. There have been only a few surveys on the prevalence of persistent HP infection in     patients who have undergone surgery. The aim of the study was to evaluate the prevalence and     histological features of HP infection after a time course of partial distal gastric surgery.   "
198766|NCT00442130|"     The purpose of this research study is to assess the safety and immune activity of a vaccine     made from the participant's own cancer cells, when administered after a reduced intensity     transplant. In recent years, researchers at Dana-Farber Cancer Institute have discovered that     vaccines made from a patients's own cancer cells, that have been engineered in the laboratory     to produce a protein called GM-CSF, can be effective in stimulating a powerful immune     response specific to that cancer.   "
198767|NCT00442143|"     The aim of the study is to investigate whether implantation of autologous bone marrow derived     stem cells in ishemics limbs will improve vascularization   "
198744|NCT00441844|"     Type I diabetes (T1DM) is associated with an increased risk of vascular complications. While     the precise mechanism(s) by which diabetes accelerates atherosclerosis has not been     elucidated, several lines of evidence point to the role of increased inflammation in the     pathogenesis of these vasculopathies. The monocyte-macrophage is a pivotal cell in     atherogenesis and is readily accessible for study. However, there is scanty data on monocyte     function and inflammation in T1DM. Simvastatin, a HMG-CoA reductase inhibitor, has recently     been shown to reduce cardiovascular events in diabetic patients (T1DM and T2DM in the Heart     Protection Study). Recent studies demonstrate that simvastatin decreased C-reactive protein     and decreased pro-atherogenic activity of monocytes in non-diabetic subjects. However, there     is a paucity of data on the effect of simvastatin on inflammation and monocyte function in     Type 1 diabetes.      Thus, the purpose of this study is Aim 1) to assess biomarkers of inflammation in T1DM     compared to matched controls (n=50/group). Aim 2) Also, we will assess the effect of     simvastatin (20mg/day) therapy on inflammation and monocyte function in T1DM in a randomized,     placebo-controlled, double blind trial.   "
198745|NCT00441857|"     This study aims to measure the effect of three different doses of plant stanols in margarine     on the cholesterol absorption efficiency in subjects with mildly to moderately increased     serum LDL cholesterol concentrations   "
198746|NCT00441870|"     This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses     of EC0225 in patients with refractory or metastatic tumors who have exhausted standard     therapeutic options.   "
198747|NCT00441883|"     This study will evaluate the safety and efficacy of PF 03187207.   "
198748|NCT00441896|"     The study is a two period (8-10 days/period), incomplete cross-over in which successive     cohorts of 9 subjects are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each     cohort, Sequence A, comprised of 6 subjects, receives ascending doses of ganaxolone during     period 1 and ganaxolone (at the maximal dose attained in period 1) and ascending doses of     placebo during period 2. Sequence B, comprised of 3 subjects, receives ascending doses of     placebo during period 1 and receives the maximum dose of placebo and ascending doses of     ganaxolone during period 2. The dosing level in each subsequent cohort will be based upon     experience gained from previous cohorts.   "
198749|NCT00441909|"     Vaginal microbicides are compounds that may protect women from HIV and other sexually     transmitted infections (STIs). This study will determine the safety of the microbicide UC-781     by comparing the effects of keeping the microbicide in the vagina for different lengths of     time.   "
198750|NCT00441922|"     This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment     in elderly patients with advanced NSCLC.   "
198751|NCT00441935|"     The study is to collect information from patient charts and patient questionnaires to     evaluate the effects of nerve stimulation therapy on urinary dysfunction.   "
198752|NCT00441948|"     The purpose of this study is to determine whether a new laser system provides better safety     and efficacy in hair removal than existing lasers.   "
198753|NCT00441961|"     Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.   "
198754|NCT00441974|"     This 48-week open-label study of local manufactured adefovir dipivoxil Tablet evaluates the     efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated CHB.     Primary endpoint is proportion of subjects achieving HBV DNA undetectable (<=1000 copies/mL     by by Roche COBAS AMPLICOR HBV MONITOR Test) at week 48. Approximately 1250 patients will be     recruited in 30 study centers in China. The subjects are offered 48 weeks of open label     adefovir dipivoxil treatment, with assessments every three months, after with is a 12-week     post study treatment follow-up prior to study completion.   "
198755|NCT00441987|"     The purpose of the protocol is to assess the initial pharmacokinetic (PK) profile of a single     oral dose of GSI-953 to healthy male Japanese subjects and healthy elderly male Japanese     subjects.   "
198756|NCT00442000|"     Compare peri-operative and postoperative outcomes of the three different surgical approaches     to prostatectomy   "
198757|NCT00442013|"     Many individuals with asthma also experience gastroesophageal reflux disease (GERD), a     condition in which excess stomach acid flows backwards into the esophagus. This study will     evaluate the effectiveness of lansoprazole, a medication commonly used to treat GERD in     improving asthma control and reducing symptoms in children with poorly controlled asthma.   "
198758|NCT00442026|"     This trial will compare the efficacy of the docetaxel and gemcitabine combination versus     monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC   "
198759|NCT00442039|"     This clinical trial is being performed under the Best Pharmaceuticals for Children Act,     signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The     purpose of this study is to examine the efficacy and safety of lithium in the treatment of     pediatric patients with bipolar I disorder.   "
198760|NCT00442052|"     Primary: To compare the gastroprotective effects of a once-daily dose of PA 325 combination     tablet combining 325 mg pH sensitive aspirin and 20 mg immediate release omeprazole versus a     once-daily dose of 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy     findings in normal healthy volunteers.   "
198761|NCT00442065|"     To assess the safety and performance of Aorfix™ Stent Grafts in the treatment of Abdominal     Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the     neck of the aneurysm or in the common iliac arteries.   "
198762|NCT00442078|"     The main objective is to evaluate the clinical efficacy on continence, quality of life and     tolerance of the sub-urethral tape I-STOP on male patient suffering of incontinence     significant and embarrassing after a radical prostatectomy.   "
198763|NCT00442091|"     Dandelion juice has been used in herbal medicine for at least 1000 years. Vesicular hand     eczema is a rare, but difficult to treat, type of hand eczema. One case report has shown that     ingestion of dandelion juice could induce a beneficial effect on this type of eczema. The     purpose of this study is to test whether this effect can be retrieved in other patients.   "
198764|NCT00442104|"     To allow open-label extension to patients who have completed Protocol 1042-0500   "
198801|NCT00442585|"     The purpose of this clinical trial is to determine whether S(+)-ibuprofen affect the platelet     inhibition under steady state acetylsalicylic acid conditions.   "
198768|NCT00442156|"     The study objective is to determine the course of changes in OCT measured macular thickness     and visual acuity following a single session of focal photocoagulation for center-involved     DME. The response will be evaluated separately in eyes with and without prior focal     photocoagulation for DME. The purpose is to determine the proportion of eyes that continue to     improve at least 5 letters in visual acuity or at least 10% in central retinal thickness     after a session of focal photocoagulation. In addition, the study will explore whether any     baseline factors can be identified that are predictive of the response.      All subjects will have follow-up visits 8 weeks and 16 weeks post treatment. At the 16-week     visit, study eyes are evaluated for change in retinal thickness and visual acuity from     baseline.        -  Treatment is to be deferred and follow up continued if visual acuity letter score has          improved by >5 or OCT central subfield thickness has decreased by >10% compared with          baseline.        -  If visual acuity letter score has not improved by at least 5 and OCT central subfield          thickness has not decreased by at least 10%, then the eye is classified as 'not          improved' and the investigator may provide additional treatment. Follow up ends for eyes          that receive additional treatment at this visit. However, if the investigator and          participant elect to defer additional treatment (even if deferral criteria are not met),          then follow up will continue until the study eye receives additional treatment for DME.        -  Eyes continuing in follow up have visits every 8 weeks (+1week) as long as there has          been continued improvement in visual acuity (letter score improved >5 ) or retinal          thickness (central subfield thickness decreased by >10%) compared with the visit 16          weeks earlier. The longest follow-up time will be 48 weeks.      By providing information on the length of time during which clinically meaningful improvement     occurs following focal photocoagulation, clinicians will be better able to determine when     further photocoagulation or other treatments should be considered for persistent DME.     Depending on the results of this study, a future randomized clinical trial will be considered     comparing the more aggressive retreatment photocoagulation regimen currently serving as the     standard DRCR Network approach to focal photocoagulation for macular edema with the less     aggressive regimen evaluated in this protocol.   "
198769|NCT00442169|"     The purpose of this study is to determine whether a single subcutaneous injection of     ChimeriVax-WN02 vaccine is well tolerated, safe and induces protective antibodies against     West Nile Disease. The study is divided into two parts; in the first part, a comparison of 3     dose levels of the vaccine will be made, with an inactive control. In the second part, the     optimum dose level chosen after the first part will be given to older volunteers.   "
198770|NCT00442182|"     Autoinflammatory syndromes (AIS) are a group of disorders characterized by recurrent episodes     of inflammation.Although for the hereditary autoinflammatory diseases the genetic mutations     are known it remains largely unclear how these mutations lead to recurrent inflammatory     attacks. Treatment of the inflammatory symptoms remains a challenge. With beneficial     responses reported during treatment with simvastatin, etanercept or anakinra in some but not     all patients. ITF2357 is an orally active histon deacetylase inhibitor with a potent     anti-inflammatory effect due to inhibition of pro-inflammatory cytokines (IL-1β, TNFα, IFNg,     IL-6). We expect that ITF2357 is able to modify the clinical symptoms of AIS patients and     induce clinical complete remission or a reduction in attack duration.   "
198771|NCT00442195|"     The Hematology Branch of the National Heart, Lung, and Blood Institute is doing a variety of     laboratory research experiments that require blood and tissue samples from healthy     volunteers. This protocol provides a mechanism for collecting these tissue samples. Research     includes studies of normal and abnormal formation of blood cells, viral blood diseases, the     role of the immune system in marrow failure and genetic risk factors for aplastic anemia.      Healthy normal volunteers 8 years of age and older may be eligible for this study. Samples     are collected as follows:        -  Blood samples: Participants 8 years of age and older donate up to 4 tablespoons of          blood, which is obtained from a needle placed in an arm vein.        -  Participants 8 years of age and older donate a buccal mucosa sample (cells from the          inside of the cheek). The inside of the cheek is scraped gently with a nylon brush.        -  Participants 18 years of age and older donate a bone marrow sample. The bone marrow is          obtained from the hip bone. The skin over the area is wiped clean with alcohol and          iodine, and then a local anesthetic is injected under the skin and also into the bone.          When the area is numb, a bone marrow aspiration needle is introduced through the bone          surface into the marrow. The marrow cells are collected using a syringe connected to the          needle.   "
198772|NCT00442208|"     Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH     (percent time pH> 4.0) following twice daily administration at different dosing times     relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5.   "
198773|NCT00442221|"     The objective of this study is to assess the safety of a single-tablet dose of Combo     Formulation for the treatment of moderate to severe migraines   "
198774|NCT00442234|"     To investigate PK and coagulating and fibrinolytic parameter profiles (PD) at the approved     dose (13,750 - 27,500 IU/kg) in patients with acute pulmonary embolism accompanying     hemodynamic instability.   "
198775|NCT00442247|"     Anterior vaginal wall prolapse is a common problem. Until now many different surgical     techniques have been evaluated but so far recurrence is often still observed. Therefore,     synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced.   "
198776|NCT00442260|"     Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in     Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) [Phase I     and II]   "
198777|NCT00442273|"     To compare the therapeutic effect between autologous serum and umbilical cord serum eyedrops     in the treatment of severe dry eye syndrome.   "
198778|NCT00442286|"     The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos     system in subjects with hypertension that are resistant to treatment with at least three     anti-hypertension agents, one of which is a diuretic.   "
198779|NCT00442299|"     The uremic syndrome is mainly related to the retention of a host of compounds, due to altered     glomerular filtration and other factors of renal dysfunction, e.g. tubular secretion. Uremic     retention solutes are arbitrarily subdivided in three different categories according to their     physicochemical characteristics and their subsequent behaviour during dialysis: (i) the     small, water-soluble, non-protein bound compounds, (ii) the larger middle molecules, mainly     peptides and (iii) the small protein-bound compounds (1).      Although direct proof is lacking, several lines of evidence indicate that albumin is the most     important carrier protein. Removal of protein bound uremic retention solutes is limited.      The Prometheus® system fractionates blood into plasma and cellular components, using an     albumin-permeable polysulfon filter (AlbuFlow®) with a specially designed sieving coefficient     curve (1.0 for 2-microglobulin, >0.6 for albumin, <0.3 for IgG, <0.1 for fibrinogen and     <0.01 for IgM). Due to the high sieving coefficient of the filter for large molecules (i.e.     cut-off at about 250 kD) molecules up to the size of albumin (69 kD) easily pass from blood     into the secondary circuit which is filled with isotonic sodium chloride solution, whereas     larger molecules like fibrinogen (340 kD) cannot pass through the filter. In the secondary     circuit the filtered plasma with the albumin-bound toxins flows through one or two adsorbers     in a row with maximized adsorption capacity for putative liver toxins that are directly     adsorbed (`fractionated plasma separation and adsorption' or FPSA). The purified plasma is     then returned to the blood side of the albumin filter. In order to eliminate water-soluble     toxins, blood thereafter undergoes hemodialysis using a conventional high-flux dialyser.      We hypothesise that removal of protein bound uremic retention solutes can be improved by FPSA     as compared to standard hemodialysis.   "
198854|NCT00443274|"     Ten year safety study examining rates of rare adverse events, child bearing issues, effects     of mammography, MRI compliance and results, and long-term benefit of silicone-filled breast     implants.   "
198780|NCT00442312|"     This study is to evaluate the efficacy and safety of Combigan ophthalmic solution in     combination with Latanoprost when the therapy is swiched from Latanoprost monotherapy in     patient with Glaucoma or ocular hypertension.      Hypothesis:        1. Combigan Ophthalmic Solution provides addition IOP loweringwhen combined with          Latanoprost.        2. The treatment with Combigan Ophthalmic Solution has an acceptable safety profile, as          measured by ocular and systemic safety parameters.   "
198781|NCT00442325|"     European physicians tend to always use the lowest dose of statins to initiate therapy even in     subjects who require large reductions in cholesterol. The study evaluates if selecting the     starting dose based on baseline and target LDL-C cholesterol would provide better results (ie     proportion of subjects resching target)   "
198782|NCT00442338|"     The study estimates the efficacy and safety of MK0476 and aminophylline intravenous     administration in adult participants with acute asthma.   "
198783|NCT00442351|"     This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study     evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with     Asmanex Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced     expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or     end of the study).   "
198784|NCT00442364|"     The purpose of this study is to determine the safety of the Varisolve® procedure in patients     with right-to-left cardiac shunt (a defect in the heart).   "
198785|NCT00442377|"     The objective of the study is to induce a protective immune response against malaria in     healthy human volunteers. The different parts of the immune response will then be studied.   "
198786|NCT00442390|"     Effects of adrenal steroids is generelly drawn from studies of hypercortisolism. The effects     of physiological cortisol substitution and withdrawal is studied and related to the clinical     syndrome of adrenal insufficiency.   "
198787|NCT00442403|"     This study aims to evaluate the safety and efficacy of a standard chloroquine drug regimen     administration supplemented with dehydroepiandrosterone sulfate against drug-resistant     malaria.   "
198788|NCT00442416|"     This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal     dialysis patients who self-inject at home or receive in-centre injections. The safety of     subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be     assessed. Eligible patients will be randomized either to receive monthly sc injections of     Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms,     or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to     reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is     3-12 months, and the target sample size is 380 individuals.   "
198789|NCT00442429|"     Morbidity and Mortality among Dialysis Patients after Treating Depression      Objectives      Our investigation has two objectives:        1. To assess whether treatment and recovery from depression decreases adverse clinical          events in chronic hemodialysis patients. Significant morbidity is associated with          depression in dialysis patients, but subsequent impact on outcome after treatment of          depression has not been reported.        2. To examine the rates of recovery from depression over a 6-month and 12-month period          among prevalent dialysis patients. Rates of recovery among dialysis patients with          depression are unclear. The natural history of depression among dialysis patients may          help long-term management.      Plan and Methods      This project is a longitudinal prospective cohort study comprised of dialysis patients from     outpatient dialysis units in the Portland, Oregon metropolitan area. Patients must be aged 18     or older and have started dialysis at least 90 days prior to enrollment. Patients are     excluded if they are delirious, demented, cannot speak English, or have a prior psychiatric     diagnosis other than depression. Baseline data collection includes patient demographics,     etiology of renal disease, nutritional status, past medical and psychiatric history and     baseline health status. Social support and quality of life assessments are obtained from     direct interview. All patients are assessed for depression by the Beck Depression Index, a     depression scale particularly useful in those with chronic illness, and the Diagnostic     Interview Scale, a gold standard for depression assessment.      Those that are depressed will undergo pharmacologic treatment with an SSRI, if they agree,     and be reassessed at 2 and 6 months for improvement. Patients who do not respond are referred     for psychiatric therapy. The primary outcome of our study is the combined rate of     prespecified morbidity and mortality at 18 months between two groups: depressed subjects     agreeing to treatment and depressed subjects not agreeing to treatment. Prespecified     morbidities include rates of 1) cardiovascular and cerebrovascular events, 2) infections, 3)     vascular access complications, and 4) death. These were selected based on prior studies     suggesting that depression increases cardiovascular and cerebrovascular events, suppresses     the immune system, and up-regulates coagulation factors and platelet aggregation. , , , , , ,      Chi-square tests and T-tests will be used to compare baseline variables among those who are     and are not depressed. A multivariable Cox proportional hazards model will compare survival     among groups, with adjustments for baseline variables. Calculations derived from the     Neyman-Pearson equation determined a sample size of 120 subjects.      Findings to date      We have enrolled 134 subjects to date, including 47 from the PVAMC, and 87 from outside     dialysis units. Twenty-percent of them have been depressed. (We need to enroll 120 depressed     patients.) No further results have been obtained this year. No further characteristics have     been analyzed to date. All adverse events have been reported, none were unexpected.      Significance      We hope to demonstrate a reduction in adverse clinical outcomes with treatment of depression.     If so, we would advocate that depression is a modifiable risk factor that warrants therapy     for well-being in dialysis patients.   "
198790|NCT00442442|"     Although mosquito coils are widely used, there is no robust evidence that their use can     provide clinical reduction in malaria. This study will randomise 4 groups of 400 houses, each     with 5 people, in rural China and monitor cases of malaria in each group each month for 6     months. The treatment groups will include Coils, Treated bed nets, Coils plus treated bed     nets, or no treatment (control). All cases detected will be given prompt appropriate     treatment.   "
198791|NCT00442455|"     The purpose of the study is to determinate the free-progression interval in patients with     surgically resected locally advanced squamous cell carcinoma of head and neck treated with     the maximum tolerated dose of the combination of erlotinib, radiation therapy and cisplatin,     previously established in a safety trial.   "
198792|NCT00442468|"     The study does not involve testing of a drug (no treatment intervention). The study will will     use spirometry (breathing tests) in subjects of 40 years of age and older with a history of     cigarette smoking with chronic bronchitis to check their disease status and whether or not     they have COPD. Also, study subjects will be asked to complete a questionnaire (to answer a     list of questions on paper).   "
198793|NCT00442481|"     The purpose of this study is to assess the effect of escitalopram on sleep architecture     utilizing a prospective design.      Hypothesis: Escitalopram will improve REM latency in patients with MDD that have responded     clinically to treatment.   "
198794|NCT00442494|"     Atrial fibrillation is the most common arrhythmia to occur after cardiac surgery.     Inflammatory response may be one etiological factor.      We hypothesized that intravenous corticosteroid administration after cardiac surgery prevents     AF after cardiac surgery.   "
198795|NCT00442507|"     Determine the time to progression for the combination of erlotinib and bevacizumab in     patients with previously treated metastatic cancer of the esophagus or gastroesophageal     junction   "
198796|NCT00442520|"     The purpose of this study is to look at several genes that might determine how the body     processes the drugs used to treat lung, colorectal and head and neck cancers. The goal of     this examination is to help investigators determine the proper dosage to give future cancer     patients or to better predict which future patients will respond to particular drug     therapies.   "
198797|NCT00442533|"     The purpose of this study is to determine if High-dose 111In-Pentetreotide known as     NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.   "
198798|NCT00442546|"     Pregabalin added to the standard of care with dosing starting preoperatively and continuing     for up to 6 weeks post surgery will decrease the intensity of post-operative pain following     total knee replacement.   "
198799|NCT00442559|"     The purpose of this study is to assess real-world effectiveness of montelukast in children (2     to 14 years) with asthma and allergic rhinitis.   "
198800|NCT00442572|"     This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS     in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and     biochemical response after treatment with interferon alfa. After 48 weeks therapy with     interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized     into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4     therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly     for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational     arm will receive no specific antiviral treatment. The anticipated time on study treatment is     1-2 years, and the target sample size is 100 individuals.   "
198802|NCT00442598|"     Primary Objectives:        -  To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects          with ovarian cancer        -  To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as          compared with every 21-day dosing      Secondary objectives:        -  To evaluate the efficacy of glufosfamide in subjects with ovarian cancer as measured by          objective response rate, duration of response, progression-free survival, and overall          survival        -  To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard during and          after treatment      Exploratory objective:        -  To correlate efficacy endpoints with expression of tumor-associated glucose transporter          proteins   "
198803|NCT00442611|"     Systemic sclerosis (scleroderma) is an autoimmune connective tissue disease that involves the     skin and other internal organs for which there are few effective treatment options. We     hypothesize that treatment with abatacept, a new therapy recently approved for the treatment     of rheumatoid arthritis, may reduce the progression of skin thickening and fibrosis in people     with scleroderma.   "
198804|NCT00442624|"     We aim to assess the influence of chronic insomnia on the neuroendocrine regulation of the     glucose and lipid metabolism to more clearly define the metabolic derangements associated     with chronic insomnia and to prove that chronic insomnia is associated with increased levels     of stress hormones, cytokines and impaired insulin sensitivity.   "
198805|NCT00442637|"     The optimal duration of systemic treatment in patients with advanced colorectal cancer is     unknown.      In this study the effects of bevacizumab and low-dose continuous chemotherapy with     capecitabine is investigated in patients who have responded to 6 courses of oxaliplatin,     capecitabine and bevacizumab (induction treatment, at standard doses). This treatment is     continued until progression or severe toxicity. This regimen is compared to the effects a     observation without treatment after the induction treatment.      In case of disease progression, induction treatment will be reintroduced.   "
198806|NCT00442650|"     Multicentre, open label, phase III study. Subjects with moderate to severe psoriasis were     given efalizumab subcutaneously once per week for the 12-week treatment period. Assessments     involved physical examination, disease activity assessments, clinical laboratory tests     (haematology, blood chemistry and standard urinalysis), evaluation of the Psoriasis Area and     Severity Index (PASI), the Physician's Global Assessment (PGA), the Patient's Global     Psoriasis Assessment (PGPA), the SF-36 Health Survey and psoriatic body surface area (BSA).     The 12-week treatment period was followed by a 12-week follow-up (FU) period, during which     other antipsoriatic medications were allowed. The same assessments were also performed in the     12-week FU period.   "
198807|NCT00442663|"     The purpose of this study is to compare the efficacy of a transcervical Foley catheter with     and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.   "
198808|NCT00442676|"     Preeclampsia is a hypertensive disorder of pregnancy and a leading cause of fetal and     maternal morbidity and mortality. Recent findings indicate preeclampsia is an inflammatory     disorder associated with increased expression of COX-2. This study will test the hypothesis     that treatment of women with a COX-2 inhibitor, celecoxib, will stop the inflammatory process     and reverse symptoms of preeclampsia.   "
198809|NCT00442689|"     The purpose of this study is to investigate the metabolic effects of anti-androgens and oral     contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We     hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs     would produce improvement in metabolic markers in PCOS women and would reduce their long term     metabolic risk.   "
198810|NCT00442702|"     This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the     treatment of anemia in patients with chronic kidney disease who are not on dialysis and who     are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized     either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly     subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the     weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
198811|NCT00442715|"     Vigorous exercise is known to cause transient bronchoconstriction in school children with     asthma, many of whom initially have normal lung function at rest. The presence and extent of     this phenomena in early childhood is difficult to recognize, because exercise induced     bronchoconstriction (EIB) may not limit the child's performance and the child may fail to     notice the symptoms until taking part in organized or competitive sport. Conversely, as     children do participate in vigorous activities all day long, severe EIB may provoke a crucial     disabling condition in the child.      In school children the exercise challenge test (ECT) is a well standardized test and is used     to make a diagnosis of asthma because it is able to discriminate between asthma and other     chronic breathing illnesses of childhood and is also used to determine the effectiveness and     optimal dosages of medications prescribed to prevent EIB.      The test includes is a controlled run on a motor-driven treadmill followed by scheduled     multiple spirometry maneuvers. This procedure was never been tested and may not be suitable     for the preschool age.      In this study we assumed that a free-run test which combined with measurements of duplicate     spirometry-sets would be the most convenient way to test young children.      The aims of this study are a) to examine the feasibility of a free-run protocol (according to     the ATS/ERS recomendations), followed by duplicate spirometry measurements in early     childhood.      b) to explore the existence of exercise induced bronchoconstriction in young children (age     3-6 years old) with respiratory symptoms.   "
198812|NCT00442728|"     The effect of neuromuscular electrical stimulation on muscle atrophy in sedated patients on     intensive care was studied. The aim of this study was to explore if electrical stimulation     could prevent muscle atrophy.   "
198813|NCT00442741|"     The purpose of this extension study is to evaluate the potential inhibitory effects of     patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.   "
198855|NCT00443287|"     The primary objective is to investigate in patients suffering from intermittent claudication     due to Fontaine stage II Peripheral Arterial Disease (PAD) whether a 26-week treatment by     HMR1766 on top of clopidogrel may result in an improvement of walking capacity, by comparing     three doses of HMR1766 to placebo, and calibrating such effect versus cilostazol.   "
198814|NCT00442754|"     Vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate     (MelCancerVac) in combination with the Cox-2 inhibitor of celecoxib for the treatment of     patients with advanced or metastatic non-small cell lung cancer (NSCLC). Adjuvant Aldara     cream will be used as adjuvant for induction of inflammation at the injection site, and the     lymphocyte growth factor of interleukin-2 (IL-2) will be given as s.c. injection. The     treatment aims at boosting the patient's specific immune system against the cancer cells.   "
198815|NCT00442767|"     The primary objective of this study is to examine the effect of pramlintide given pre-meal     and insulin given just after a meal has been taken vs. standard therapy of pre-meal insulin     on post-prandial glucose excursions.      The secondary objective is to examine the effect of pramlintide and insulin on glucagon     suppression in type 1 diabetes.   "
198816|NCT00442780|"     The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is     tolerated when given at different doses to patients with early-stage Parkinson's Disease.      This study will also explore:        -  How BIIB014 is affected when given to patients with early-stage Parkinson's Disease          (this will be done by measuring the levels of BIIB014 in the blood at several different          times during the study), and        -  The activity of BIIB014 when given to early Parkinson's patients (this will be done by          performing different Parkinson's Disease assessments and other tests during the study).      Patients who enter this study will be randomly assigned to receive either BIIB014 or a     placebo but because the study is blinded, neither they nor their study doctor will know which     study treatment they are taking.   "
198817|NCT00442793|"     This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta,     in patients with chronic renal anemia who are on dialysis. Eligible patients will be     randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta     (3 times weekly, according to approved labelling). The anticipated time on study treatment is     3-12 months, and the target sample size is 100-500 individuals.   "
198818|NCT00442806|"     The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived     Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute     myocardial infarction.   "
198819|NCT00442819|"     Background: Uremic pruritus is one of the common complications in long-term dialysis     patients. In general, many factors including xerosis, elevated serum calcium, phosphate,     calcium-phosphate product, hyperparathyroidism and inadequate dialysis may contribute to it.     Recently, researchers reported that immuno-hypothesis with high serum level of cytokines     could be the cause of uremic pruritus. Polymethylmethacrylate (PMMA) artificial kidney (AK)     has been reported to adsorb more serum cytokines than other high flux artificial kidneys.      Methods: In July 2006, 30 patients with severe uremic pruritus from 300 chronic hemodialysis     patients in a single center entered this prospective study. Their dialyzers were changed to     PMMA AK for 4 weeks. The severity of pruritus was evaluated every week using the results of a     questionnaire (pruritus score). Laboratory assays including pre-dialysis serum blood urea     nitrogen, creatinine, β2-microgblubulin (β2M), calcium, phosphate, intact parathyroid hormone     (iPTH), total CO2, ferritin, hematocrit, high sensitivity C-reactive protein (hsCRP), IL-1,     IL-2, IL-6, IL-18, TNF-α, KT/V and β2M clearance were measured before and at the end of 4     weeks of PMMA AK use.      Expected Results:To prove the PMMA membrane could improve the uremic pruritus and to reveal     the effect of PMMA membrane on serum level of possible factors contributing to uremic     pruritus.   "
198820|NCT00442832|"     The purpose of this study is to determine whether TD-1792 is safe and effective when used to     treat complicated skin and skin structure infections caused by Gram-positive bacteria.   "
198821|NCT00442845|"     Physicians tend to always use the lowest dose of statins to initiate therapy even in subjects     who require large reductions in cholesterol. The study evaluates if selecting the starting     dose based on baseline and target LDL-C cholesterol would provide better results (ie     proportion of subjects resching target)   "
198822|NCT00442858|"     The aim of the present study was therefore two-fold: 1) to make a retrospective comparison of     incidence of non-fatal stroke and cardiac events between a large cohort of patients with     confirmed GHD on replacement therapy (including GH) and a control cohort from the general     population; 2) to compare the prevalence of DM and cardioprotective medication between the     cohorts at the time of questionnaire distribution with adjustment for possible confounders     and effect modifiers.   "
198823|NCT00442871|"     The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down     in the body by healthy subjects versus subjects with mild, moderate or severe kidney     problems. The study is also being done to 1) check on how well the study drug is tolerated by     healthy subjects versus those with liver problems and 2) to check if liver impairment affects     how the study drug binds to protein in the blood.   "
198824|NCT00442884|"     The study is designed to evaluate the effects of acute psychological stress on blood glucose     levels. We will study one group of patients in the fasting state on a control day and a     stress test day, another group will undergo the same protocol in the postprandial state.   "
198825|NCT00442897|"     Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving     ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment     panel (ATP) III guidelines   "
198826|NCT00442910|"     There is an urgent need for HIV prevention methods that women can initiate and control     themselves. Topical microbicides, substances that kill microbes, represent one such method.     The purpose of this study is to assess the safety and to evaluate the acceptability of 3% w/w     SPL7013 gel, a topical microbicide, when administered intravaginally for 14 consecutive days     in healthy, sexually active HIV uninfected women.   "
198827|NCT00442923|"     The purpose of this research study is to determine whether Carvedilol, an FDA approved beta     blocker, when administered for an 8-week period to veterans currently undergoing treatment     for methamphetamine dependence (1) improves their ability to stay in treatment longer,     (2)eases the aversive symptoms that accompany stimulant withdrawal, and (3) increases the     time they remain abstinent from methamphetamine.   "
198856|NCT00443300|"     The goal of this clinical research study is to learn if the protected environment (PE) can     help to prevent infections in patients aged 60 and above who are receiving what is considered     low-intensity treatment for newly-diagnosed AML or high-risk MDS.   "
198828|NCT00442936|"     The purpose of this study is to investigate the efficacy and safety of telcagepant (MK-0974)     compared to an approved medication for acute migraine. This study was conducted as a     triple-dummy design; for each dose of study drug, participants each received 3 forms of     study drug (2 capsules of active and/or placebo and 1 tablet of active and/or placebo) and     were instructed to take one of each form of study drug at dosing time.      The primary hypotheses of this study are that telcagepant is superior to placebo in Pain     Freedom at 2 Hours Post-Dose, Pain Relief at 2 Hours Post-Dose, Absence of Photophobia at 2     Hours Post-Dose, Absence of Phonophobia at 2 Hours Post-Dose and Absence of Nausea at 2 Hours     Post-Dose.   "
198829|NCT00442949|"     Release of troponin evaluated by the peak of troponin during the hospital phase.Because of     its sensitivity and specificity as well as its widespread use in routine practice, rise in     troponin levels is the main assessment criteria of this study. We plan to demonstrate a     significantly altered distribution of the troponin release as evaluated by the peak of     troponin for each patient during the hospitalization period (from randomization to     cardiologic unit discharge), in the two arms of the trial.   "
198830|NCT00442962|"     The purpose of this study is to determine if pregnancy-limited, short-term combination HIV     treatment regimens -- which were used solely for the prevention of mother to child     transmission of HIV and discontinued postpartum -- decreases the effectiveness of a standard     initial regimen of anti-HIV drugs when subsequent treatment is needed.   "
198831|NCT00442975|"     The study is being undertaken to evaluate responses to seasonal influenza vaccine in older     adults with respect to their CMV status. CMV is cytomegalovirus and is an organism that     infects many people, but does not usually cause disease in the individual unless they are     immunocompromised i.e. their immune system is not working well such as in the case of HIV     infection. CMV is believed to have infected up to 80% of individuals in the age group we will     be looking at in our study and we are interested in whether this infection affects their     responses to vaccination.   "
198832|NCT00442988|"     A statistical analysis of the predictive value of OGTT and FPG testing executed as part of     standard clinical practice after renal transplantation for the diagosis of new-onset diabetes     mellitus after transplantation.   "
198833|NCT00443001|"     This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in     subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of     the ANSI/AAMI SP10 Standard.   "
198834|NCT00443014|"     The Dementia Study in Northern Norway is an open controled intervention trial carried out in     nine rural municipalities, five of which allocated to intervention and four to control. A RCT     with donepezil and placebo is superimposed on all patients included in the study. In this way     the study has a 2x2 factorial design. The outcome measures are changes in cognitive     performance and ADL function measured by standardized cognitive and neuropsychological tests     every four months during a one-year follow-up.      The main goal of this study is to examine the effect of systematically and individually     adjusted stimulation therapy on cognitive function in patients having recent diagnoses of     Alzheimer´s disease (AD).      A secondary goal is to examine whether or not ChEI has an additional effect on cognitive     function superimposed on stimulation therapy.      From January 2006 to 31th March 2008 187 patients with a recent diagnosis of dementia were     included. Patients were recruited by GPs in routine practice (n=87) and by a population based     screening (n=100).Screening recruited younger patients with a higher MMSE-score, and     relatively more men. All over, women were older and at a more serious disease stage. After     age adjusting significantly more women were living single and required more supports from the     community nursery.   "
198835|NCT00443027|"     The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical     system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a     control unit. Output data is collected on a PC. By measuring the clearance of heat from the     heated probe, a direct measure of absolute blood flow can be obtained. The study will assess     changes in vaginal blood flow across the menstrual cycle following visual sexual stimulation.   "
198836|NCT00443040|"     The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients     who have undergone a laparoscopic segmental colectomy and determine whether it reduces the     time to recovery of bowel function compared to placebo.   "
198837|NCT00443053|"     To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of     acute (recent) superficial thrombophlebitis.   "
198838|NCT00443066|"     Spinal Muscular Atrophy (SMA) is the leading genetic cause of death in infancy. It is a     devastating disease that leads to progressive loss of those nerve cells that control our     muscle bulk and movement. Patients develop increasing weakness in all muscles, eventually     including those needed for breathing. In more than half of patients, SMA starts in infancy     and typically leads to death within the first 2 years of life. In others, the disease begins     in childhood and leads to significant disability.      SMA is caused by a defect in the Survival of Motor Neurons (SMN1) gene. Researchers are     hopeful to find a cure, because nature has provided humans with a second gene, almost an     identical copy of the SMN1 gene. Normally, the second gene does not contribute much, but     researchers think that its function can be increased by medications.      To find out whether these medications help patients with SMA, we have to conduct clinical     trials. Here, we propose to prepare for clinical trials. We will invite SMA patients to join     our research effort. We will examine them regularly to better understand their disease. The     visits will include questions, physical exam, blood drawing, and sometimes X-rays and a skin     biopsy. We will use modern computer methods to process the information. While we are doing     this, we will plan a clinical trial. Once the clinical trial begins, we will offer SMA     patients participation if they meet the criteria for that trial.      We will make sure that the participants' privacy is maintained and that the study risks are     as low as possible.      Identifying an effective SMA treatment is very important because there is currently none.     Clinical trials are the only way to decide whether a new treatment works in SMA patients or     not.   "
198890|NCT00443742|"     The objective of the study is to improve general practitioners' diagnoses of adolescent     depression. Major depression is ranked fourth in the worldwide disability impact. The     proportion of adolescents suffering from depressive disorders also seems to be increasing     worldwide. Early interventions are known to reduce this illness. Therefore, the earlier     depression can be identified in adolescents, the greater the advantage.   "
198839|NCT00443079|"     The purpose of this study is to evaluate the dietary supplement Siliphos, which comes from     milk thistle, to determine whether it is safe and well-tolerated in adults who have     non-alcoholic steatohepatitis (NASH). An additional aim of this study is to determine whether     Siliphos may be beneficial in treatment of NASH as indicated by improvement in liver enzymes     (ALT and AST). The study hypothesis is that Siliphos will be safe and well-tolerated in     people with NASH and will result in a decrease in the liver enzymes ALT and AST.   "
198840|NCT00443092|"     The primary purpose of this research study is to test the ability of a proprietary cherry     juice blend to be helpful in the treatment of osteoarthritis (OA) of the knee.   "
198841|NCT00443105|"     The purpose of this study is to determine the efficacy, tolerance and safety of tacrolimus     0.03% ointment in the treatment of intractable allergic conjunctivitis.   "
198842|NCT00443118|"     A multicenter cross-over cluster randomized controlled trial protocol study in newborn     infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure     ventilation [PPV]) for resuscitation in the delivery room comparing a T-piece resuscitator     device versus resuscitation bag.   "
198843|NCT00443131|"     In this study, two experimental malaria vaccines (with adjuvants) are tested to evaluate and     characterise how the vaccine exactly works on the immune system by comparing it to a control     (without adjuvant). The Protocol Posting has been updated in order to comply with the FDA     Amendment Act, Sep 2007.   "
198844|NCT00443144|"     The protein polymorphism of the growth hormone receptor characterized by the genomic deletion     of exon 3 has been linked to the magnitude of the first-year-growth response to growth     hormone (GH) in girls with Turner syndrome.      Objective: to study the long-term effect of GH therapy in Turner syndrome in correlation to     this GHR polymorphism in a mainly retrospective design (chart-review).   "
198845|NCT00443157|"     This study is the third in a series using the MenB vaccine from the National Institute of     Public Health in Norway (NIPH). The vaccine was first made in response to a high incidence of     disease using the 44/76 strain which was resopnsible for most of the disease there. The VEC     did the first study, MNB1, using this vaccine. Since then the NIPH has formed a commercial     partnership with Chiron Vaccines and has reformulated the vaccine using the NZ98/254 MenB     strain for use in New Zealand.      The vaccine was first produced at NIPH facilties and it was this vaccine that was used in our     second study, MNB2. The current study, MNB3, will use the NZ98/254 MenB vaccine but from     Chiron facilities where production has been scaled up in order to provide enough doses for     the national immunisation campaign that is ongoing in New Zealand.   "
198846|NCT00443170|"     This is a first time in human study to investigate the safety of GSK626616AC given as oral     single and repeat doses in healthy subjects. An additional group of subjects will be assessed     to determine the effect of several drugs given at the same time as GSK626616.   "
198847|NCT00443183|"     Patients with hazardous and harmful alcohol consumption are at increased risk for adverse     health consequences and have frequent visits to the Emergency Department(ED). Despite     research that has demonstrated the prevalence of alcohol problems in ED patients, there are     limited data on the effectiveness of brief intervention (BI) strategies for patients in this     setting. The purpose of the current study is to evaluate the effectiveness of a brief     intervention, termed Brief Negotiation Interview (BNI), provided by emergency practitioners     (EPs-emergency physicians and physician assistants), in reducing alcohol consumption in ED     patients with hazardous and harmful drinking. In a controlled randomized clinical trial of     500 patients with hazardous and harmful drinking, BNI will be compared to scripted discharge     instructions (DI). Three hypotheses will be tested: BNI is superior to DI in: 1) reducing     alcohol consumption; 2) reducing the number of binge drinking episodes; and 3) increasing     utilization of primary care or alcohol-related services. Alcohol consumption and utilization     of primary care or alcohol-related services will be measured by self-report at 1,6 and 12     months. An additional benefit to changing patterns of consumption and utilization of health     services may be decreased ED visits and alcohol-related hospitalizations. These will be     assessed utilizing a statewide database. In order to facilitate real-world application of BNI     in the ED, the project will result in a BNI manual for EPs and an adherence and competence     scale. Unique features of the current project as compared to earlier studies include: 1)use     of a credible control condition; 2) enrollment of a heterogeneous population; 3)use of a     manual-guided intervention by existing ED staff; 4)systematic assessment of adherence and     competence to ensure quality administration and discriminability of interventions;     5)monitoring of use of ancillary treatments; and 6)monitoring of repeat ED visits and     alcohol-related hospitalizations.   "
198848|NCT00443196|"     2.0 Study Objectives: 2.1 To evaluate the ability of the MiCK assay to predict the outcome of     chemotherapy of cancer patients for first-line treatment.      2.2 To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients in a     third-line, refractory treatment setting (exclusive of anti-VEGF)   "
198849|NCT00443209|"     The purpose of this study is to investigate the safety and tolerability of telcagepant     (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary     hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of     acute migraine in adult participants.   "
198850|NCT00443222|"     This is a 4 month open trial with TNF-blockade using infliximab (an antibody that blocks TNF)     in adult patients with chronic myositis (polymyositis, dermatomyositis, inclusion body     myositis) who have persisting muscle weakness and inflammatory active disease despite     adequate treatment with immunosuppressives either currently or previously.      Infliximab is given as infusions, 5 mg/kg body weight, these infusions are repeated after 2,     6 and 14 weeks. The study involves 15 adult patients.      Primary outcome measure is muscle function assessed by muscle function index score.      Other outcome measures are Myositis Disease Activity core set: Patient’s global assessment     and physicians global assessment on visual analogue scales (VAS). Manual muscle test, Health     assessment questionnaire (HAQ), serum levels of CPK, LD and extra muscular disease activity     score. Muscle biopsy, Magnetic resonance imaging (MRI) of thigh muscles and Health related     Quality of life, measured by SF-36.   "
198851|NCT00443235|"     The primary objective is to analyze and compare the efficacy, the response rate, the CR and     the response rate duration of both induction treatments and both maintenance treatments   "
198852|NCT00443248|"     The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical     system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a     control unit. Output data are collected on a PC. By measuring the clearance of heat from the     heated probe, a direct measure of absolute blood flow can be obtained. The study will assess     the technique's ability to differentiate between pre- and post-menopausal women; with and     without Female Sexual Arousal Disorder (FSAD).   "
198853|NCT00443261|"     To evaluate the safety and toxicity of azacitidine (5-azacitidine, Vidaza®) and cisplatin     combination in patients with squamous cell carcinoma of head and neck (SCCHN).   "
198857|NCT00443313|"     Background:        -  Cancer of the cervix (bottom third of the uterus, or womb) can be prevented by regular          Pap tests (also called Pap smears), which check for changes in the cells of the cervix.          Because many women in the United States have regular Pap smears, cervical cancer is not          common in this country. However, the disease is common among women in the Mississippi          Delta because of poor participation in screening programs.        -  The major causes of cervical cancer are persistent human papillomaviruses (HPV)          infection by cancer-associated HPV types and lack of screening. These viruses cause an          infection that often goes away by itself, but if it does not go away, over a long time          lead to cervical cancer. HPV causes cervical abnormalities, which are detected by Pap          smears and then treated.      Objectives:      -To determine whether an at-home self-collection method for obtaining cells from the cervix     can be a simple, safe and inexpensive way to screen for cervical cancer for women who don t     go to the health clinic regularly.      Eligibility:        -  Women who reside in the counties of Leflore, Sunflower, Washington or Tallahatchie,          Mississippi.        -  Women between 26 and 65 years of age who are not pregnant and who have not had a          hysterectomy.      Design:      Screening study participants undergo the following:        -  The doctor takes a cervical sample using the same self-collection device that women will          use at home to self-collect.        -  Pelvic examination and Pap test. For this test, the woman lies on an exam table and the          doctor inserts an instrument called a speculum into the vagina, opening it to see the          cervix. A special brush is used to take a few cells from the cervix. The cells are          placed on a glass slide and sent to a lab for examination.        -  Cervical cell specimen collection using an at-home self-collection kit that participants          will use at home after 2 weeks        -  At-home self-collection by participant after 2 weeks.        -  Referral to a doctor for follow-up care, if needed.        -  Colposcopy (see below) in all women with a Pap test that is abnormal or positive for HPV          and for some women with a normal smear.      Colposcopy study participants undergo the following:        -  The doctor takes a cervical sample using the same self-collection device that women will          use at home to self-collect.        -  Colposcopy, an exam in which the doctor examines the cervix using a light and looks          through a magnifying device to see if there is any abnormal tissue on the cervix. During          this exam, the doctor may remove a small sample of tissue to diagnose any abnormality.          Participants also have a sample collected using the self-collection kit.        -  At-home cervical sample collection by participant after 2 weeks.        -  Notification if further medical care is required and treatment if the biopsy looks          abnormal.   "
198858|NCT00443326|"     Investigational drug AMG 714 will be given to 66 subjects with moderate to severe psoriasis     to study safety, pharmacokinetics, and efficacy. Dose levels include 150mg and 300mg and will     be given to each subject for a total of 6 doses. Each dose for each subject will be given     once every 2 weeks. Subjects will followed for up to 300 days post the first dose of AMG 714.   "
198859|NCT00443339|"     This is an evaluation of the effectiveness of darbepoetin alpha in treating anemia of MDS     patients with an International Prognostic Scoring System (IPSS) score of low or intermediate     1.   "
198860|NCT00443352|"     This is a single-center, open-label, pilot trial to collect and evaluate data on the safety     and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic     migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered     into an 84-day treatment period. Subjects will be titrated over the first four weeks to a     dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on     individual subject response and/or subject's tolerability. Subjects will maintain a daily     diary capturing detailed information on migraine headache days.   "
198861|NCT00443365|"     The purpose of this study is to assess whether adding mitral valve repair to coronary artery     bypass grafting improves outcome in patients with ischemic mitral regurgitation.   "
198862|NCT00443378|"     This study evaluates an interactive computer counseling tool to help HIV-positive individuals     develop an integrated health promotion plan incorporating antiretroviral (ART) adherence and     HIV transmission risk reduction. We hypothesize that evidence-based counseling for ART     adherence support and for HIV transmission risk reduction can be delivered effectively in a     self-administered computer tool.   "
198863|NCT00443391|"     The objective of this study is to evaluate the long-term safety and tolerability of ABT-089     in adults with ADHD.   "
198864|NCT00443404|"     Severe pre-amputation pain is associated with phantom pain development, and phantom pain     models assign major importance to central and peripheral nervous system changes related to     pre-amputation pain. Several interventions have been evaluated for phantom pain prevention,     including continuous brachial plexus blockade5, intravenous6 or epidural ketamine     administration, postoperative perineural ketamine/clonidine infusion8 and oral gabapentin9,     but their true effect remains unclear.   "
198865|NCT00443417|"     The purpose of this study is to find optimistic dose and to evaluate the efficacy and safety     of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.   "
198866|NCT00443430|"     The purpose of this study is to compare two aggressive drug regimens for children with     poly-juvenile idiopathic arthritis (JIA) and extended oligo JIA.   "
198867|NCT00443443|"     This is an observational study designed to follow patients with RA who have had an inadequate     response to one or more anti-TNF therapies and who will receive Rituxan. Approximately 1000     patients in the United States with RA who have had an inadequate response to anti-TNF     therapies and who will receive Rituxan therapy will be recruited. There is no protocol     mandated treatment assignment in this study. Patients will be evaluated and treated according     to their physician's standard practice and discretion.   "
198868|NCT00443456|"     To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects     who will be able to enter a long-term study after completing the parent study A double-blind     comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension     for whom amlodipine 5 mg is insufficiently effective (Protocol No.: A0531085).   "
198869|NCT00443469|"     It involves delivering a train of magnetic pulses, 5 at each time, to the brain. In the     present study, we are using the same method to treat severe pain due to nerve conditions. You     will be given up to 1000 pulses in total over the spine in the lower back (Spinal Magnetic     Stimulation or SMS). Each train will be given in 10-second intervals. You will have SMS on a     single day. You will be given SMS pulses at 1 or 10 per second. No stimulation will be given     over the head.      You will be assessed before and after the study for up to 1 week. Your usual medical     treatment will be continued   "
198870|NCT00443482|"     This study is designed to demonstrate that formoterol 12µg and 24µg delivered by a new     inhalation device (Concept1) are equivalent to the corresponding dose of formoterol delivered     by the Aerolizer device in terms of efficacy, in patients with persistent asthma.   "
198871|NCT00443495|"     Chitin microparticles (CMP) has been demonstrated in animal studies that have modelled     allergic rhinitis to be effective against a wide range of common respiratory allergens. It is     an immuneenhancer.      The primary purpose of the study is to demonstrate safety in a first into man study on 24     human volunteers. The secondary objective is to demonstrate efficacy by chosing subjects that     demonstrate a response to a nasal allergen challenge using grass pollen.      The subjects are being given increasing doses of CMP, supplied as a nasal spray, for 7 days     followed by a nasal allergen challenge with Timothy Grass Pollen extract. Over this period     nasal symptom scores, eosinophil counts and cytokine measurements will be performed.   "
198872|NCT00443508|"     This study is design to compare two different strategies aiming to lessen the degree of the     ongoing process of allograft injury either by removing tacrolimus from the maintenance     immunosuppressive protocol or by reducing tacrolimus dose.      The primary goal is to assess the change in renal function at 6 and 12 months after     conversion using creatinine levels and calculated creatinine clearance.      The study will include two groups: The study group of 30 patients and a matched control group     with creatinine levels at similar range.   "
198873|NCT00443521|"     The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide     after laser panretinal photocoagulation in the treatment of proliferative diabetic     retinopathy.   "
198874|NCT00443534|"     This protocol allows subjects who have participated in a previous SU011248 protocol the     ability to continue to receive SU011248 after their study has ended.   "
198875|NCT00443547|"     The purpose of this study is to measure the benefits of anterior (from the front) cervical     (neck) surgery for degenerative disc disease. The research part of this study is the     answering of questionnaires by the patient concerning their quality of life, prior to, and     after surgery.   "
198876|NCT00443560|"     The objective of this study will be to compare epidural infusion management, specifically     looking at infusion rate changes, in patients who receive forceps deliveries versus normal     spontaneous vaginal deliveries. We will match patients based on time and date of delivery, as     well as parity, in order to eliminate these variables as potential con-founders.      We hypothesize patients who require a decrease in their basal labor analgesia epidural     infusion rate will have an increased incidence of forceps delivery.   "
198877|NCT00443573|"     This is a multicenter, two-stage trial with the goal of evaluating up to 100 subjects. This     trial will be performed to initiate identification of a safe and effective dose of     twice-weekly, subcutaneous rNAPc2 for the second-line treatment of metastatic colorectal     carcinoma in combination with contemporary 5-FU-based chemotherapy.   "
198878|NCT00443586|"     This study will evaluate the long-term effects of a prenatal and early childhood home nurse     visitation program for socially disadvantaged women and their children.   "
198879|NCT00443599|"     Critically ill children, including children undergoing heart surgery, commonly develop     elevated blood glucose (also known as blood sugar) levels during their illness, which can     lead to poor health outcomes and an increased risk of death. This study will examine the     effectiveness of maintaining normal blood glucose levels at decreasing infections and     improving recovery in young children undergoing heart surgery.   "
198880|NCT00443612|"     Primary:        1. To compare the change in forearm vascular resistance following a 12-week regimen of          irbesartan/hydrochlorothiazide versus irbesartan        2. To assess changes of serum proinflammatory cytokine, markers of cardiovascular risks,          oxidative stress and circulating adhesion molecule including thiobarbiturate acid          reactive substances (TBARS), C-reactive protein (CRP), interleukin 6 (IL-6), and          vascular cell adhesion molecule 1 (VCAM-1).      Secondary:        1. To compare the reduction in office blood pressure following a 12-week regimen of          irbesartan/hydrochlorothiazide versus irbesartan        2. To compare the response rate (defined as office Systolic blood pressure(SBP)/diastolic          blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate          (defined as SBP<140 mmHg and /or DBP<90 mmHg)        3. To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus          irbesartan when administered once daily        4. To determine whether angiotensin II type 1 (AT-1) receptor gene polymorphisms (including          A1166C gene with about 4% of the minor allele frequency in Chinese population and other          single nucleotide polymorphisms with a higher frequency of about 10% of minor allele) is          related to reduction of BP   "
198881|NCT00443625|"     This study was designed to investigate the food effect of SK3530 on the pharmacokinetics     (PKs).   "
198882|NCT00443638|"     The Elmira follow-up study is designed to assess the extent to which prenatal and infancy     home visitation by nurses affects the life-course development of 19-year-old youth whose     mothers received those services during pregnancy and the first two years of the child's life.   "
198883|NCT00443651|"     This is a Phase III, open-label study of a total of approximately 560 subjects with active     rheumatoid arthritis (RA) who have had an inadequate response to one or more     disease-modifying anti-rheumatic drugs (DMARDs). Enrollment in the study was conducted in two     stages. In Stage I of the study, approximately 400 subjects receiving non-biological DMARDs     (with the exception of methotrexate [MTX] monotherapy or MTX and leflunomide combination     therapy) were enrolled. In Stage II of the study, approximately 160 subjects receiving a     Federal Drug Administration-approved biological DMARD at the time of screening were enrolled.   "
198884|NCT00443664|"     To prove that external contact micropulse diode laser trabeculoplasty (EMDLT) can     significantly lower intraocular pressure in cases of advanced open angle glaucoma.   "
198885|NCT00443677|"     The purpose of this study is to compare the toxicities of the COPPEBVCAD vs BEACOPP vs ABVD     regimens.   "
198886|NCT00443690|"     To evaluate the effect of KW-3902IV, in addition to standard therapy, on the proportion of     worsening heart failure and worsening renal function, and on the proportion of deaths or     rehospitalizations for heart failure or worsening renal function, and to estimate and compare     within-trial medical resource utilization and direct medical costs between subjects treated     with KW 3902IV versus placebo.   "
198887|NCT00443703|"     The purpose of this study is to investigate the efficacy, safety, and tolerability of an     investigational treatment for patients with HIV.   "
198888|NCT00443716|"     To evaluate the effect of estrogen treatment on adipocytic and osteoblastic parameters by     histomorphometrically measuring adipocyte volume (AV/TV) and adipocyte numbers in goldner's     stained iliac crest bone biopsy specimens collected from subjects recruited in the study (IRB     number 21B85). The adipocytic parameters will be then correlated with osteoblastic parameters     obtained previously during the course of the initai study involving the effect of transdermal     estrogen on bone turnover in postmenopausal osteoporotic women.   "
198889|NCT00443729|"     The purpose of this study is to investigate the efficacy, safety, and tolerability of an     investigational treatment for patients with Human Immunodeficiency Virus (HIV).   "
199248|NCT00455598|"     The purpose of this study is to provide an initial assessment of the safety, tolerability and     efficacy of ISIS 113715 in combination with sulfonylurea in type 2 diabetes subjects.   "
198893|NCT00443781|"     The primary objective of this study is to document and compare diagnostic test results and     procedure safety in subjects undergoing both Functional Anaesthetic DiscographyTM (F.A.D.)     and provocative discography (PD) and determine the appropriateness of the F.A.D. procedure     data collection script for use in a larger clinical trial.   "
198894|NCT00443794|"     STUDY TITLE A randomized double-blind controlled trial of the efficacy and safety of the     POLYCAP® versus its components in subjects aged 45 to 80 years of age with at least one     additional cardiovascular risk factor.      STUDY OBJECTIVES This study is designed to assess the efficacy and safety of the POLYCAP®, a     fixed dose combinationcontaining 5 drugs (an antiplatelet drug; 3 blood pressure lowering     agents, a beta blocker, an ACE inhibitor, a diuretic and a statin.      STUDY DESIGN      Randomized controlled double-blind trial of the POLYCAP® versus its components in eight     formulations.      STUDY POPULATION Subjects between 45 and 80 years of age, with at least one additional CVD     risk factor.      INVESTIGATIONAL PRODUCTS Composition POLYCAP® and its comparators FOLLOW UP The total     duration of follow up will be 4 months, from the start of study medication.. Subjects will     take study medication for 3 months. There will be a final follow up visit 1 month after     stopping the study medication.      There will be five follow up visits, the first 7 - 10 days after starting study medication     and thereafter monthly visits for 4 months. Subjects taking any of the study medications     prior to enrolment will have one or more additional visits during a defined wash out and     before enrolment.      OUTCOME MEASURES Mean difference of change in BP, LDL and urinary thromboxane at the end of     the three month period.      STATISTICAL ISSUES Non-inferiority evaluation of the POLYCAP in modifying BP, lipids and     platelet activity [as measured by urinary thromboxane] when compared with its different     components in eight different formulations.   "
198895|NCT00443807|"     A highly desired result in neuroanesthesia is a prompt, controlled emergence following a     neurosurgical procedure. Considerable strides have been made in this direction with volatile     anesthetic agents such as sevoflurane or desflurane administered in association with the     narcotic remifentanil. It is characteristic that patients will emerge within 5 to 10 minutes     of cessation of these agents at the end of a neuroanesthetic. However, there are cases where     emergence is delayed, especially after periods of deep anesthesia for i) cerebral protection     with temporary clipping of cerebral aneurysms and ii) with microvascular decompression for     trigeminal neuralgia. Deep levels of anesthesia are standard for these procedures in the     posterior fossa, which utilize motor evoked potentials to assess cranial nerve function. In     these cases, EEG monitoring is standard. Using the EEG to monitor emergence to aid its     progress makes sense. A monitor which could predict emergence in these patients would be     valuable. EEG monitoring engineered to provide this information is now available in the form     of the EEGo. This study is designed to test the hypothesis that the EEGo monitor will be     superior to the BIS monitor to assess emergence following neuroanesthesia.   "
198896|NCT00443820|"     This study is designed to assess the efficacy, safety and tolerability of a topical     formulation of terbinafine solution applied daily in patients with toenail fungus. This trial     will study patients with mild to moderate toenail fungus disease of the big toenail and their     responses to two treatment durations, 24 or 48 weeks.   "
198897|NCT00443833|"     Thyrotoxic periodic paralysis (TPP) is characterized by episodes of reversible hypokalemia     and weakness in thyrotoxic patients. It is commonly found in males of Asian descent and is     also seen in individuals having Native American or Hispanic ancestry. Therefore genetic     etiology has been hypothesized. This study, we aim to find the susceptibility genes that     associate with TPP. Both candidate genes approach and genome wide association study have been     conducted.   "
198898|NCT00443846|"     Primary objective:      To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine     without impairing the efficacy of MCC vaccine.      Secondary objectives:        -  Efficacy: Additional immunogenicity assessments.        -  Safety: To describe the safety profile of RotaTeq® and of the MCC vaccine when          administered concomitantly with RotaTeq®.   "
198899|NCT00443859|"     Babies who are suspected of having persistent pulmonary hypertension (PPHN) will be included     in this study. PPHN is a condition in which the blood is restricted from flowing to the lungs     in a normal way making it hard for babies to breath and placing strain on the heart. This     study will observe whether certain hormones that measure stress (N-terminal pro-brain     natriuretic peptide) can help determine how well a baby will do when they have PPHN.   "
198900|NCT00443872|"     The purpose of the study is to determine if reducing or eliminating a dopamine agonist (DA)     causing one of the side effects of daytime sleepiness, swelling of the lower legs or feet,     hallucinations or impulsive behaviors while adding orally disintegrating selegiline can     eliminate the adverse effect and maintain control of Parkinson's disease (PD) symptoms.   "
198901|NCT00443885|"     The isolate samples will be collected over a period of one year once IRB approval has been     obtained. These isolates were collected as part of the patient's clinical care and once all     clinical testing is complete, all isolates will be discarded. The honest broker of our area     will collect the isolates and deidentify all information once all clinical testing is     complete. The isolates will be obtained from the microbiology lab.   "
198902|NCT00443898|"     This study is designed to assess the efficacy, safety and tolerability of a topical     formulation of terbinafine solution applied daily in patients with toenail fungus. This trial     will study patients with mild to moderate toenail fungus disease of the big toenail and their     responses to two treatment durations, 24 or 48 weeks.   "
198903|NCT00443911|"     Age-related macular degeneration is one of the major causes of blindness in the western     world. There is an exsudative and a non-exsudative form of age-related macular     degeneration.Most studies concentrate on the exsudative form. In the non-exsudative form the     policy is generally watch and see, but patients are at risk to develop an exsudative form. So     far, the only accepted therapy to reach stable disease in the non-exsudative form is     high-dose supplementation of antioxidants. Another approach to improve visual acuity in     patients with non-exsudative form of macular degeneration is rheohemapheresis treatment, an     extracorporeal therapy where plasma is separated from blood cells. By the use of a hollow     fiber filter plasma is depleted of high molecular weight proteins and reinfused. Others     report describe the supplementation of lutein (a vitamin A derivative) as possible treatment     option. However, none of the studies have yet examined a combination of rheohemapheresis and     lutein supplementation.   "
198904|NCT00443924|"     The purpose of this trial is to evaluate the safety and tolerability of INS115644 Ophthalmic     Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma     and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic     Solution.   "
198905|NCT00443937|"     Cyclosporine (CNI), a potent immunosuppressive drug used in transplant recipients to prevent     graft rejection, can cause renal impairment in some patients. The aims of this study are        -  To determine the influence of CNI discontinuation on the drug exposure and key          pharmacokinetic parameters of everolimus and enteric-coated mycophenolate sodium          (EC-MPS)        -  To determine the adequate dosing of everolimus and EC-MPS in a CNI-free regimen        -  To investigate the CNI-free regimen with EC-MPS and everolimus with respect to safety          (e.g. rejection rates) and tolerability        -  To investigate renal function after CsA withdrawal   "
198906|NCT00443950|"     The objective of this study is to compare in Chinese subjects with rheumatoid arthritis (RA)     the efficacy and safety in this subject population of 50 mg once-weekly injections of     etanercept versus placebo in subjects receiving methotrexate. This is a multi-center,     double-blind, randomized, parallel and placebo-controlled outpatient study. Approximately 150     subjects will participate in this study for about 18 weeks including a screening period up to     4 weeks, 12-week treatment period, and a 2-week follow-up period at approximately 25 sites.   "
198907|NCT00443963|"     We hypothesize that patients receiving NSAID drugs with dyspeptic symptoms have increased     production of gastric levels of free radicals. The primary objective of the study is to     determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and     decreases gastric free radical production in humans. Patients (age 18 years and older) with     no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and     then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All     eligible individuals will undergo biopsies of antrum and corpus. The subjects will be     randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all patients will     undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will     then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an     indirect marker of free radical production).   "
198908|NCT00443976|"     RATIONALE: Aurora kinase inhibitor AT9283 (AT9283) may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of AT9283 in treating     patients with advanced or metastatic solid tumors or non-Hodgkin's lymphoma.   "
198909|NCT00443989|"     We will conduct a prospective cohort study evaluating the incidence of and optimal risk     estimation model for major perioperative cardiovascular events in consecutive patients     undergoing noncardiac surgery at the 'Herlev University Hospital'. This national pilot study     in Denmark together with other national studies will inform the feasibility of a large     prospective international cohort study.   "
198910|NCT00444002|"     Hepatitis C virus infection (HCV) is a major health concern in Canada and worldwide. Chronic     HCV can cause progressive liver damage leading to inflammation, scarring and, in some cases,     cirrhosis or liver cancer. It has been shown that fat accumulation in the liver can     accelerate the disease progression and is therefore a risk factor in HCV patients.      However, the exact mechanism(s) by which fat accumulation in the liver is involved in disease     progression are not clear yet. It is possible that the presence of fat provides a liver     susceptible to a second injurious process which leads to scarring. Candidates for this second     hit may include insulin resistance, leading to accumulation of fat within the liver cells     and secondly oxidation of these lipids. In turn, lipid peroxidation can lead to production of     reactive oxygen species (unstable molecules that can damage cells) and cytokines (signal     molecules that promote inflammation) resulting in more oxidative stress and liver damage.      Aim of the study is to find out, whether patients with HCV and fatty liver have increased     oxidative stress and inflammation than patients with HCV without fatty liver, and whether     this is associated with a different nutritional status.   "
198911|NCT00444015|"     This is a single site phase I dose escalation trial of the epidermal growth factor receptor     inhibitor Erlotinib with the SRC tyrosine kinase inhibitor Dasatinib in patients with     previously treated advanced stage (Stage IIIB/IV disease) Non-Small Cell Lung Cancer (NSCLC).     The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets     starting Day 9 for a 28-day cycle. If there are no Dose Limiting Toxicities (DLTs), dose     escalation continues. The recommended phase II dose for this combined treatment will be     defined and patients will be treated at the recommended phase II dose to confirm     tolerability.   "
198912|NCT00444028|"     Staccato Loxapine is being developed for the treatment of acute agitation in patients with     schizophrenia. A 50 patient, dose escalation Phase I clinical trial was completed in November     2005.   "
198913|NCT00444041|"     Major attempt is being given to the potential of curing patients with metastatic colorectal     cancer due to the recognition of dramatic change in survival figures achieved in palliative     chemotherapy combination treatment protocols. Achieving resectablity rates in previously     unresectable patients has been defined as study endpoint among other well known primary and     secondary objectives. Curing metastatic colorectal cancer is most likely in resectable     patients and therefore the logical next step after completion of chemotherapy combination     studies (e.g. EORTC 40983) is the addition of targeted agents. Bevacizumab has the most valid     data of improving outcome figures and was therefore chosen as additional agent. Safety of the     combination with Xelox was demonstrated in the investigators pilot trial (Gruenberger JCO     2006, ASCO 2006, WCGC 2006, ESMO 2006), consequently response rate and resection rate will be     the primary endpoints in this trial.      STUDY OBJECTIVES      Primary Objective The primary objective of this study is the Resectability (R0) rate after     neoadjuvant Bevacizumab in potentially resectable mCRC.      Secondary Objectives The secondary objectives of this study include        -  Feasibility with regards to GI bleeding and wound healing complications after surgery of          liver metastases        -  General safety        -  Overall Response Rate (ORR)        -  Recurrence Free Survival (RFS)        -  Overall Survival (OS)      STUDY DURATION Recruitment is planned for 12 months. Patients will be treated for 6 cycles     XELOX and 5 cycles Bevacizumab. Surgery will be performed 2 weeks after the last Capecitabine     administration, allowing a time window of 5 weeks between the last Bevacizumab administration     and surgery.      Therapy with 6 cycles of XELOX and Bevacizumab will be restarted 4-5 weeks after surgery.      With a Follow up period of 2 years after the last enrolled patient, in order to assess RFS     and OS, the trial will last for approx. 3 years.      NUMBER OF CENTRES Four centres with a high level of experience in the surgery of liver     metastases are planned to participate in this study.      SELECTION CRITERIA      Total Number of Patients and Target Population The planned total sample size for this study     is 43 patients. Patients with potentially resectable metastatic colorectal cancer previously     untreated for metastatic disease will be enrolled in this trial.   "
198956|NCT00450385|"     The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell     lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or     by presence of biomarkers associated with the anti-tumor effects of Rituximab.   "
198914|NCT00444054|"     This study is for people whose cancer:        -  has resisted chemotherapy        -  are taking a break from chemotherapy        -  or are looking for an alternative to the toxic effects of chemotherapy      The trial is looking to see if a very low carbohydrate diet can inhibit the growth of certain     cancers.      The two major goals of the RECHARGE study are to determine:        -  whether a very low carbohydrate diet can help participants reduce the amount of cancer          in their bodies (as measured by a PET scan at the beginning and end of the study)        -  whether participants can feel well while maintaining their weight on a very low          carbohydrate diet      This research study is for people with advanced cancers who decline chemotherapy or want to     take a break from chemotherapy and have cancers that primarily feed on blood sugar. Examples     of such cancers include metastatic breast cancer, colon cancer, cervical and uterine cancers,     ovarian cancers, and many others.      The investigators' intervention consists of a 28-day diet of high protein foods such as fish,     poultry, meats, eggs and cheese as well as plenty of vegetables. Participants may eat as much     of the high protein foods as they wish and can eat up to two cups of vegetables per day.      Participants strictly eliminate carbohydrate-containing foods. These foods include all     starches and sweets (breads, pasta, rice, potatoes, cereals, fruit, cakes, candies, soda with     sugar, etc.).   "
198915|NCT00444067|"     To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of     care techniques.   "
198916|NCT00444080|"     A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to     trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to     medical treatment and for which filtering surgery is indicated   "
198917|NCT00444093|"     Therapy-associated diarrhea during radiation therapy of small pelvis (including enteritis as     a result of radiation therapy and enteritis as a result of radiation- and chemotherapy) is a     common problem in multimodal cancer therapy. We investigate the therapeutic effect of either     loperamide or tinctura opii in therapy- associated diarrhea in patients who receive radiation     therapy of the small pelvis with or without chemotherapy.   "
198918|NCT00444106|"     To evaluate the potential effects of artemether- lumefantrine on the auditory function   "
198919|NCT00444119|"     The purpose of this survey is to assess patients with chronic primary or secondary adrenal     failure regarding subjective health status, incidence and causes of adrenal crisis, hormone     replacement regimens and concomitant endocrine or non endocrine disease.   "
198920|NCT00444132|"     Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in     patients with coronary artery disease. In the proposed study we wish to prospectively assess     the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with     clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients     who demonstrate non-responsiveness to clopidogrel.   "
198921|NCT00444145|"     The purpose of the study is to determine if tissue changes are predictor of clinical response     to therapy.      The hypothesis is that the patients who have laryngeal signs and symptoms related to acid     reflux, will have ultrastructural changes on a laryngeal biopsy which are predictors of     response to therapy.   "
198922|NCT00444158|"     MOA-728, an investigational drug, is currently being studied for the relief of constipation     associated with postoperative ileus and treatment of opioid induced constipation in patients     receiving palliative care. This study will further investigate the IV formulation of MOA-728     comparing PK/PD time points for a 20-minute versus a 4-hour infusion.   "
198923|NCT00444171|"     Randomized controlled trial to compare blood glucose control by the model predictive control     algorithm with variable sampling rate (eMPC) with routine glucose management protocol (RMP)     in peri- and postoperative period in cardiac surgery patients.   "
198924|NCT00444184|"     This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus     travoprost when both medications are dosed in the evening. Such a crossover comparison may     determine the real efficacy of the new fixed combination versus travoprost monotherapy. The     results should enhance the investigators understanding on the best dosing of TTFC and may     influence its clinical use in Europe. Finally, the results would better delineate the future     role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with     PG analogs and timolol. This study should assist the general ophthalmologist worldwide to     plan optimal stepwise medical therapy.   "
198925|NCT00444197|"     Study Aims: 1) Assess the receptiveness of youth and families to injury prevention     interventions initiated from the emergency department; 2) In a sample of high risk youth     presenting to the ED with interpersonal assault injuries, determine the effectiveness of a     home-based family intervention with community linkage compared to a control group.   "
198926|NCT00444210|"     This study is being undertaken to:        -  evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic          acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment          of dermal nasolabial fold wrinkles at 13 months following the last application of study          treatment.        -  Document the types and incidence of adverse events reported with DL6049 (injectable          poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events          will be assessed for an additional 12 months following discharge from the main study in          subjects treated with DL6049.   "
198927|NCT00444223|"     RATIONALE: Fluorine F 18 FEQA may be an effective radioactive drug to use with positron     emission tomography (PET) scans.      PURPOSE: This clinical trial is studying the use of fluorine F 18 FEQA in patients with stage     III or stage IV non-small cell lung cancer and in healthy participants.   "
198928|NCT00444236|"     We propose that acid reflux affects respiratory dynamics (breathing) in patients who are     exercising and that athletes improve their exercise capacity with acid suppression therapy.     It is our intent to determine whether treatment of GER with strong acid suppression may     alleviate symptoms, improve exercise capacity, and improve quality of life.   "
198992|NCT00452491|"     1. To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens        2. To specify the best period of treatment        3. To assess the efficacy of treatment based on final adult height of these children   "
198993|NCT00452504|"     This is a first-in-humans study of SRA-444. This study will provide an initial assessment of     the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRA-444 (SR     formulation) after administration of ascending single oral doses to healthy adult subjects.   "
198929|NCT00444249|"     The blue light hazard has been reported to cause retinal damage (oxidative stress),     particularly to the central fovea due to its energetic, shorter wavelength visible photons,     which is why blue-light filtering intraocular lenses have been developed for cataract     surgery. The hormone melatonin has been reported to possess an efficient antioxidant     capacity. Light information from the eye reaches the suprachiasmatic nuclei and inhibits     melatonin secretion. Since melatonin is suppressed by light, we have a day-night rhythmicity,     with increased levels at night. Melatonin suppression is wavelength-dependent with a peak     sensitivity in the 446-477 nm (blue light) portion of the visible spectrum. The crystalline     lens blocks most UV between 300 and 400 nm. The density of the lens increases with aging     causing an alteration in the spectral absorption. The greatest increase in absorption occurs     at the short wavelength end of the spectrum (around 400-470 nm). Age-related pupillary miosis     and crystalline lens yellowing limit the blue light reaching the retina. This reduces the     older adults' effective retinal light exposure to one tenth that of younger people. It has     been shown that insomnia and depression decrease after cataract surgery and patients returned     to youthful levels of melatonin. Since melatonin acts as an antioxidant, and more blue light     filtering intra ocular lenses are implanted and thought to reduce photochemical damage in the     macula, it would be interesting to show the positive influence of those blue light filtering     intraocular lenses on daytime levels of melatonin in age-related macular degeneration     patients.   "
198930|NCT00444262|"     The aim of this study is to assess whether intra-operative fluid supplementation (to improve     tissue perfusion) can reduce the incidence of postoperative complications in elderly patients     with hip fracture.   "
198931|NCT00444275|"     To compare the efficacy of three different long-term treatment strategies of reflux disease     in primary care setting.   "
198932|NCT00444288|"     Polycystic Ovary Syndrome, or PCOS, is the most common endocrine disorder in women. Depending     on the strictness of the diagnostic criteria used, it is thought to occur in about 6-10% of     all women, many of whom do not know they have the syndrome. Women with PCOS produce     abnormally high levels of male hormones (hyperandrogenism); this counteracts their ovaries'     ability to make enough of the female hormones estrogen and progesterone needed for normal     menstruation. PCOS is the number one cause of hormonally related infertility and also     increases women's risks for diabetes, high blood pressure, hypercholesteremia, cardiovascular     disease and certain cancers. It is currently unclear to what extent PCOS and PCOS-associated     traits (hyperandrogenisms, hyperinsulinemia, insulin resistance, type 2 diabetes,     dyslipidemia, hypertension, obesity, and coronary artery disease) are the results of     environmental factors or genetic predisposition. Therefore, the NIEHS Program in Clinical     Research is conducting a multi-phase twin study to measure the extent of PCOS heritability     and to identify environmental and genetic factors involved in the development of PCOS. The     proposal described here is for Phase 2 of this study. The goals of Phase 2 are to: 1)     establish more reliable concordance rates and baseline heritability estimates for PCOS in MZ     and DZ twins; and 2) establish a cohort of intact MZ and DZ female twin pairs as a resource     for future studies.      In Phase 1, about 1500 individual female twins were identified from the Mid-Atlantic Twin     Registry (MATR) based on self report of a history of irregular periods and/or cystic ovaries     in the MATR General Health Screening Questionnaire. Those twins were surveyed by phone for     other traits associated with PCOS. In Phase 2, the twins most likely to have PCOS based on     their answers to the Phase 1 phone survey will be recontacted for further PCOS screening.     This includes providing a blood sample for measuring bioavailable testosterone (BaT) levels.     Women with elevated BaT levels are likely to have PCOS. The women with elevated levels will     then be asked to undergo a medical evaluation for PCOS confirmation. This includes a physical     exam, medical history, ultrasound, 2-hour glucose tolerance and other biochemical blood     tests, and a Ferriman-Gallwey evaluation for abnormal hirsutism (another characteristic of     PCOS). The women will also be tested for pregnancy and zygosity. Their female co-twins will     be invited to undergo...   "
198933|NCT00450073|"     The purpose of this study is to establish an effective method to correct vitamin D deficiency     in subjects with cystic fibrosis. The investigators will examine cholecalciferol,     ergocalciferol and UV light.   "
198934|NCT00450086|"     The purpose of this study is to determine whether budesonide or mesalazine is more active in     the treatment of collagenous colitis.   "
198935|NCT00450099|"     Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of the     most commonly used drugs for that purpose. The efficacy of a certain medication injected     epidurally depends on the dose that is given. A certain dose can be administered in different     concentrations, which will consequently mean different volumes. Our hypothesis is that for     each concentration of a certain drug, there has to be a minimum effective volume that will be     associated with the best possible performance of the drug. This study is being conducted to     find the minimum volume of bupivacaine (a local anesthetic) that produces successful     analgesia in 95% of patients in labor.   "
198936|NCT00450112|"     The purpose of this study is to determine if a single or repeat intra-articular injection of     Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to     determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.   "
198937|NCT00450125|"     The goal of this clinical research study is to compare the 6-minute walk test with the     exercise stress test, in patients who may have lung surgery. Researchers want to find out if     the 6-minute walk test is as good as the exercise stress test at predicting possible     complications that may occur after lung surgery.   "
198938|NCT00450138|"     The purpose of this study is to determine the maximum tolerated dose of ZD6474 given in     combination with radiation or in combination with chemotherapy and radiation in patients with     squamous cell carcinoma of the head and neck.   "
198939|NCT00450151|"     In this study the focus will be on correlating the levels of platelet activation markers     (proteins that are released when blood cells are activated)to the duration of cardiopulmonary     bypass, temperature during cardiopulmonary bypass and the weight of the patient.   "
198940|NCT00450164|"     Controlled and randomized study comparing combined treatment (nadolol and endoscopic     ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to     hemodynamic response, in the prevention of esofagic verices rebleeding.   "
198941|NCT00450177|"     The purpose of this study is to investigate the efficacy of enteral iron supplementation for     improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in     patients who are hospitalized in the intensive care unit. This study will also address any     relationship between enteral iron supplamentation and risk of infection.   "
198942|NCT00450190|"     The aim of the study is to evaluate the E-Device performances and handling on the use in     common practice, by collecting the impressions of patients, nurses and the investigator on     the graphic interface, the instructions manual, the E-Device training and the material     itself.   "
199249|NCT00455611|"     To assess modifications of ventricular function induced by CPAP (Continuous Positive Airway     Pressure).   "
198943|NCT00450203|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin, cisplatin, and capecitabine, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, and small molecule     tyrosine kinase inhibitors, such as lapatinib, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor     cells by blocking blood flow to the tumor. Lapatinib targets a specific growth receptor,     HER-2. Chemotherapy together with bevacizumab or lapatinib, in HER-2 positive tumours, may     kill more tumor cells.      PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving     combination chemotherapy together with bevacizumab works compared with combination     chemotherapy alone in treating patients with previously untreated stomach cancer,     gastroesophageal junction cancer or lower oesophageal cancer that can be removed by surgery.     The feasibility study is studying the safety of adding lapatinib to chemotherapy in patients     with HER-2 positive previously untreated stomach cancer, gastroesophageal junction cancer or     lower oesophageal cancer that can be removed by surgery. The feasibility study will also     assess the feasibility of timely HER-2 testing and estimate the HER-2 positivity rate in this     patient population.   "
198944|NCT00450216|"     The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of     development of ibuprofen-associated ulcers in patients who require long-term daily use of     ibuprofen.   "
198945|NCT00450229|"     Giving diindolylmethane, a substance found in cruciferous vegetables, may help doctors learn     more about how diindolylmethane is used by the body. This randomized phase I trial is     studying the side effects and best dose of diindolylmethane compared with a placebo in     treating patients undergoing radical prostatectomy for stage I or stage II prostate cancer.   "
198946|NCT00450242|"     -  Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability          to have sexual intercourse and decreased pain scores in women with vestibulitis when          compared to placebo.        -  This is a study to assess if topical lidocaine will improve symptoms in women with          vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo          ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total          of 56 women in the study.   "
198947|NCT00450255|"     This phase II trial is studying how well VEGF Trap works in treating patients with recurrent     stage III or stage IV melanoma that cannot be removed by surgery. Combinations of biological     substances in VEGF Trap may be able to carry tumor-killing substances directly to melanoma     cells. It may also stop the growth of melanoma by blocking blood flow to the tumor.   "
198948|NCT00450268|"     We plan to investigate prospectively and simultaneously skin and blood DC subtypes, their     donor/recipient origin and the correlation of DC reconstitution kinetics with treatment,     clinical outcome and incidence of aGvHD in patients undergoing allogeneic hematopoietic stem     cell transplantation.   "
198949|NCT00450281|"     RATIONALE: Studying samples of blood and tissue from smokers (closed to entry as of 7/15/07)     and non-smokers with cancer in the laboratory may help doctors learn more about changes that     occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more     about risk factors for lung cancer and may help the study of cancer in the future.      PURPOSE: This clinical trial is studying carcinogens in lung tissue from smokers (closed to     entry as of 7/15/07) and non-smokers with newly diagnosed stage I, stage II, or stage III     non-small cell lung cancer.   "
198950|NCT00450294|"     The objective of this study will be to answer a clinical question that has not already been     investigated; that is, what are the effects of aortic infra-renal clamping and unclamping on     intraocular pressure during Abdominal Aortic Aneurysm (AAA) repair? Depending on the results,     this study may raise or alleviate concern that vascular surgery for abdominal aortic aneurysm     could contribute to early perioperative exacerbation of pre-existing eye disease and increase     a patient's vulnerability to developing a type of blindness known as ischemic optic     neuropathy. The purpose of this observational study is to evaluate whether intraocular     pressure measurements with a handheld tonometer will detect changes in intraocular pressure     related to intraoperative events during aortic cross clamping and unclamping that may provide     information on causes of perioperative blindness.   "
198951|NCT00450307|"     RATIONALE: Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Colony-stimulating factors, such as GM-CSF,     may increase the number of immune cells found in bone marrow or peripheral blood. Giving     monoclonal antibody therapy together with GM-CSF may be an effective treatment for     neuroblastoma.      PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody     3F8 when given together with GM-CSF in treating young patients with high-risk, refractory or     relapsed neuroblastoma.   "
198952|NCT00450320|"     RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Sirolimus also may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth and by blocking blood flow to the tumor.      PURPOSE: This pilot study is studying sirolimus in treating patients with HIV-related     Kaposi's sarcoma.   "
198953|NCT00450333|"     The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly     and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as     measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of     efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients     previously stable on EPO, as measured by Hb over Weeks 16 to 24.   "
198954|NCT00450359|"     RATIONALE: A computer-aided detection program may help doctors find breast cancer sooner,     when it may be easier to treat, in women undergoing screening mammography.      PURPOSE: This randomized clinical trial is studying how well computer-aided breast cancer     detection works in women undergoing screening mammography.   "
198955|NCT00450372|"     RATIONALE: Pegylated arginine deiminase may stop the growth of tumor cells by taking away an     amino acid needed for cell growth.      PURPOSE: This phase II trial is studying how well pegylated arginine deiminase works in     treating patients with metastatic melanoma that cannot be removed by surgery.   "
198957|NCT00450398|"     The study is designed to assess the feasibility of evaluating YSPSL for the amelioration of     ischemia reperfusion injury following liver transplantation by administering YSPSL into the     liver graft directly ex vivo via the portal vein and to the recipient intravenously prior to     reperfusion. Recently, P-selectin expression has been associated in liver grafts with     prolonged cold storage times and rejection. By examining biomarkers of IRI including     P-selectin by immunohistochemistry and/or quantitative PCR, liver histology and hepatic blood     flow using established techniques, the goal of this study is to evaluate the feasibility of     using these modalities for future studies of safety and efficacy.   "
198958|NCT00450411|"     RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a     tumor to kill tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided     implant radiation therapy works in treating patients with locally recurrent prostate cancer     previously treated with external-beam radiation therapy.   "
198959|NCT00452062|"     Laryngotracheal injury related to intubation may cause narrowing of the airway due to edema     of the glottis. Post-extubation airway frequently necessitating re-intubation and resulting     in the prolongation of intensive care. Factors correlating with the development of     post-extubation stridor include age, female gender, an elevated Acute Physiologic and Chronic     Health Evaluation II, trauma related to endotracheal intubation, excessive ETT size,     unnecessary tube mobility, increased cuff pressure, frequent tracheal aspirations, infection,     arterial hypotension, and a prolonged intubation period. Because the presence of an     endotracheal tube (ETT) precludes direct visualization of the upper airway, recognition of     edema due to laryngotracheal injury is often difficult. However, upper airway patency may be     measured indirectly in the intubated patient by documentation of a leak around the ETT upon     deflation of the sealing balloon cuff encircling the ETT. Controversy currently exists     regarding the effectiveness of prophylactic steroid therapy for patients considered at high     risk for post-extubation stridor. Only a limited number of prospective trials involving     adults and evaluating the benefits of corticosteroid therapy prior to extubation have been     conducted.      Studies regarding the efficacy of prophylactic corticosteroids for intubated patients have     yielded conflicting results due to differences in the number of doses or types of     corticosteroids administered.      The present study was conducted to evaluate the effects of prophylactic dexamethasone therapy     for a subset of high-risk patients who had been intubated for > 48 hours and who were     undergoing their first elective extubation in an ICU setting. The specific objectives were to     determine whether multiple doses of dexamethasone are effective in the reduction or     prevention of post-extubation airway obstruction in patients with a cuff leak volume (CLV) <     110 mL and to ascertain whether an aftereffect follows the discontinuation of dexamethasone.   "
198960|NCT00452075|"     A phase II study of Tarceva (Erlotinib) and predictive markers as first-line treatment of     advanced non-small cell lung cancer for patients unfit for chemotherapy (NSCLC) Clinical     Phase II Stage IIIB or IV non-small cell lung cancer (NSCLC) Primary end point: Disease     control rate (= CR+PR and SD at 8 weeks /patients). Secondary end point: Safety (Serious     Adverse Events, Adverse Events leading to premature withdrawal, unexpected TarcevaTM related     AEs) .Correlation of EGFR expression rate (HER1) and FISH potentially predictive for     response.      An open-label, non randomized, multicenter, clinical trial of TarcevaTM as single agent The     sample size is 29 patients in 2 stages and based on Simon´s optimal 2 stage design. Stage 1     will accrue 10 patients, if less than 1 response is observed the study will stop; if more     than 1 response is observed the accrual will continue up till 29 patients. A total of 29     patients would be entered and the treatment will be declared to have sufficient activity to     deserve further attention if at least 5 patients obtain disease control.   "
198961|NCT00452088|"     This will be a study of the safety of MSP 3 LSP candidate malaria vaccine in children aged     1-2 years in Burkina Faso. Three imminizations at 28 day intervals will be administratered     subcuteneously on the shoulder region. The study will compare MSP3 with Engerix B vaccine to     evaluate whether it is just as safe to give to children in malaria endemic country. The study     will also evaluate whether the vaccine induces the expected immune responses. Two dose levels     of MSP 3 will be evaluated; 15µg and 30µg to determine the one with the best safety and     immune response profile.   "
198962|NCT00452101|"     The objective of this trial is to evaluate the effect of Aquamin F alone or in combination     with glucosamine sulfate versus placebo on symptoms of joint pain, stiffness and immobility     in subjects with painful osteoarthritis of the knee. The following hypotheses were tested:      (Hypothesis 1) After 12 weeks of treatment, subjects taking Aquamin F alone or in combination     with glucosamine sulfate will have significantly less joint pain, stiffness and immobility     compared to subjects taking glucosamine sulfate alone or placebo alone.      (Hypothesis 2) No significant differences will be seen for adverse events between the     subjects taking Aquamin F, glucosamine sulfate, Aquamin F + glucosamine sulfate or placebo.   "
198963|NCT00452114|"     This study is a randomized, controlled trial examining the effectiveness of the mechanical     cough-assist device (in-exsufflator) in promoting the clearance of retained airway secretions     in patients with symptomatic bronchiectasis. We hypothesize that this enhanced clearance of     airway secretions will lead to a decline in the number of acute exacerbations of     bronchiectasis experienced by these patients during the study period, improve health-related     quality of life, decrease overall health-care costs and improve pulmonary function.   "
198964|NCT00452127|"     This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of     single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL.     The trial will enroll in two phases: a Phase I dose-escalation portion for patients with     indolent NHL and a Phase II portion with enrollment of additional patients with follicular     NHL into two expanded treatment cohorts in order to expand the safety database and collect     preliminary anti-lymphoma activity data.   "
198965|NCT00452140|"     The purpose of the study is to demonstrate clinical efficacy of the investigational     trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or     2+ (FISH-) expressing advanced or metastatic breast cancer (stage III b/IV) which has     progressed after endocrine therapy.      Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu and CD3 on T cells.     Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new     antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages,     dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to     preclinical data, trifunctional antibodies activate these immune cells, which can trigger a     complex anti-tumor immune response.   "
198994|NCT00452517|"     During the 6-month period 119 patients with acute coronary syndrome, were randomized to     either stent graft group (n=40), sirolimus eluting stent group (n=39), or bare metal stent     group (n=40). Demographic, angiographic and procedural characteristics were similar for all     three groups. The incidence of 6-month major adverse coronary events were analysed.   "
198966|NCT00452153|"     The validity of molecular techniques for the diagnosis of legionellosis is not known.     Although PCR can detect Legionella pneumophila (responsible for 80% of legionellosis) and     other Legionella species, this test is not recommended in standard guidelines to assess this     diagnostic, by contrast to culture of sputum, serology and urine antigen. The aim of this     study is to evaluate Legionella PCR techniques, performed directly onto the sputum aspirates,     for the routine diagnosis of pneumonia in adults' patients admitted to hospital. This study     implicates 3 University hospitals (Lyon, Grenoble and Saint-Etienne) in collaboration with     the French reference center of legionellosis for a previous duration of one year. In addition     to the usual diagnostic tests that are performed when pneumonia is suspected, real-time PCR     will be added for the detection and differentiation of Legionella. Hypothesizing the     inclusion of 1000 pneumonia in this study, the predictable number of newly-detected     legionellosis will be approximately 60 to 70 cases. According to a predefined algorithm,     cases of legionellosis will be classified as definite or probable. Sensitivity and     specificity of the real-time PCR will be calculated according to this classification. This     study is intended to validate real-time PCR as a tool for the rapid diagnosis of     legionellosis, allowing to optimize the antibiotic treatment of pneumonia. PCR techniques can     also contribute to the better detection and differentiation of Legionella sp infections that     are not documented accurately by routine microbiologic tests.   "
198967|NCT00452166|"     30 non-diabetic, non-obese patients with stage 4 chronic kidney disease will be asked to     participate in this metabolic study.      The primary aim of this study is to determine the effect of rosiglitazone on insulin     resistance in non-obese patients with non-diabetic stage 4 CKD.      Secondary end points are the effects on inflammation (hsCRP), lipid profile, bone density and     body composition.   "
198968|NCT00452179|"     The purpose of this study is to determine the effects of APD125 in patients with sleep     maintenance insomnia.   "
198969|NCT00452192|"     A major complication of diabetes mellitus is diabetic nephropathy. In previous studies the     investigators could demonstrate that in patients with type 2 diabetes mellitus despite     unaltered basal and stimulated nitric oxide (NO) - activity, the renal response to the     antioxidant vitamin C was more pronounced compared to control subjects. These data suggest     that oxidative stress is increased in the renal vasculature of diabetic patients.     Furthermore, NO-activity in diabetic patients appears to be up regulated to compensate for     increase in oxidative stress. This hypothesis is supported by the demonstration of increased     endothelial nitric oxide synthase (eNOS) expression in kidney biopsies of diabetic patients.      Angiotensin receptor blockers have been found to reduce oxidative stress in various vascular     beds. Some drugs of this class, Telmisartan for example, also exhibit partial agonist     properties to the PPARγ receptor and might be of great benefit for patients with diabetes     mellitus or metabolic syndrome due to an additional improvement in insulin resistance.     Despite its effect on oxidative stress angiotensin receptor blockers beneficially alter renal     haemodynamics by reducing intraglomerular pressure and thus protect against glomerular     injury.      Recent advances in magnetic resonance imaging lead to the development of new techniques that     allow a separate measurement of renal medullar and cortical perfusion. This magnetic     resonance imaging technique might be a useful tool to detect alterations at an early level in     the kidneys of patients at high risk for diabetic nephropathy. In the current study, the     investigators want to evaluate the new magnetic resonance imaging technique by measuring     medullar and cortical renal perfusion before and after pharmacological intervention with     telmisartan in patients with metabolic syndrome.   "
198970|NCT00452205|"     The purpose of this study is to clarify the relationship bone marrow-derived cells and the     formation of the tumors, and the role of these cells in regeneration of epithelial cells in     the gastrointestinal tract.   "
198971|NCT00452218|"     The purpose of this study is to assess the safety and tolerability of sorafenib in patients     with PAH already on existing therapy with a prostacyclin [epoprostenol (Flolan)],     treprostinil (Remodulin), or iloprost alone, or with or without sildenafil (Viagra/Revatio).   "
198972|NCT00452231|"     The purpose of this study is to investigate if the effectiveness of cognitive-behavioral     therapy for post-traumatic stress disorder can be increased by combining it with     D-cycloserine (TCC/D-cycloserine) by comparing with a placebo (TCC/placebo).   "
198973|NCT00452244|"     The epidermal growth factor receptor (EGFR) is a key regulator of growth, differentiation,     and survival of epithelial cancers. In a small subset of tumors, the presence of activating     mutations within the ATP binding site confers increased susceptibility to gefitinib, a potent     tyrosine kinase inhibitor of EGFR. Agents that can inhibit EGFR function through different     mechanisms may enhance gefitinib activity in patients lacking these mutations. Mevalonate     metabolites play significant roles in the function of the EGFR; therefore, mevalonate pathway     inhibitors may potentiate EGFR-targeted therapies. Targeting HMG-CoA reductase, the     rate-limiting enzyme of mevalonate pathway, using lovastatin induces a potent apoptosis in a     variety of tumor types. In an in vitro study, combining gefitinib and lovastatin treatment     showed synergistic cytotoxic activity through enhanced inhibition of AKT activation by EGF in     NSCLC and head & neck cancer cell lines. Therefore, the investigators would like to compare     the combination effect of gefitinib and simvastatin, the specific and protein inhibitor of     HMG-CoA reductase, with gefitinib alone in previously treated patients with NSCLC.   "
198974|NCT00452257|"     The primary objective of this study is to see if enzastaurin affects the pGSK3 beta level in     B-cell chronic lymphocytic leukemia (B-CLL) cells.   "
198975|NCT00452270|"     The aim of this study is to characterize the time profile of the decongestant properties of     xylometazoline and to investigate its effect on sleep, general well-being and smell/taste.   "
198976|NCT00452283|"     There is growing evidence that a cause of glaucoma is linked to circulatory problems and poor     auto-regulation of blood flow to the optic nerve. Pulmonary hypertension (PH)is a disease     characterized by low oxygen levels in the blood and altered blood circulation. The decrease     in oxygen delivery to the optic nerve could lead to the loss of nerve fiber layer(NFL)in the     retina and the resulting visual field compromise. This situation is characteristic of     glaucoma. The ability to identify NFL thinning early could lead to earlier diagnosis of     glaucoma and more effective treatment to limit dysfunction from visual field loss.      We hypothesize that the rate of structural damage to the NFL, a feature of glaucoma, is     higher in patients with PH than expected in healthy populations lacking this disease.   "
198977|NCT00452296|"     Glucose control has been shown as an important and independent prognostic factor in several     acute conditions in hospitalized patients, including Acute MI, stroke, cardiac surgery and in     critical care units.      Patients with acute exacerbation of COPD (AECOPD)and diabetes treated with insulin had a     longer in-patient stay and more frequent isolation of Gram negative bacteria from sputum than     those without diabetes.Hyperglycemia (>11 mmol/l) on admission predicted failure of     non-invasive ventilation and infectious pulmonary complications in patients admitted to the     ICU with acute respiratory failure caused by severe AECOPD.      The primary goal of this study is to test the hypothesis that in AECOPD, tight glycemic     control during hospital stay will improve outcome of hospitalization.      The secondary goal of this study is to test new ways in controlling patients in the internal     medicine ward.   "
198978|NCT00452309|"     The purpose of this study is to test a correction factor which would allow ankle brachial     indexes taken in the seated position to accurately predict an ankle brachial index taken in     the supine position.   "
198979|NCT00452322|"     Treatment of male hypogonadism by testosterone substitution has be monitored in terms of     safety. This study relates to safety of a new long-acting preparation.   "
198980|NCT00452335|"     The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a     pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a     subset of patients.   "
198981|NCT00452348|"     This purpose of this study is to show the superiority and long term safety and efficacy of     adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid     (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of     asthma control will provide key information on the efficacy and safety of the combination     therapy. The safety measure will be an assessment of adverse events   "
198982|NCT00452361|"     This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI)     to sirolimus (SRL) results in improved long-term renal function without a negative impact on     safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce     the severity and/or progression of chronic allograft nephropathy (CAN).   "
198983|NCT00452374|"     Primary Objectives:        1. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of          oxaliplatin in combination with fludarabine, Ara-C and rituximab in patients with          Richter's transformation, prolymphocytic leukemia (PLL), or refractory/relapsed B-cell          chronic lymphocytic leukemia (CLL).        2. Assess the complete response (CR) and partial response (PR) rate to combination therapy          of oxaliplatin, fludarabine, Ara-C and rituximab in patients with Richter's          transformation, PLL or refractory/relapsed B-cell CLL.        3. Determine the safety and toxicity profile of combination therapy of oxaliplatin,          fludarabine, Ara-C and rituximab in patients with Richter's transformation, PLL or          refractory/relapsed B-cell CLL.      Secondary Objectives:        1. Determine the duration of response, failure-free survival, and overall survival.        2. Determine the incidence of infections (bacterial, fungal, and viral) in patients with          Richter's transformation, prolymphocytic leukemia or refractory/relapsed B-cell CLL          treated with rituximab, oxaliplatin, fludarabine and Ara-C; monitor immune parameters          such as T cell counts and immunoglobulin levels; and monitor Epstein-Barr virus (EBV)          status.        3. Characterize the pharmacodynamics of oxaliplatin in leukemia cells with respect to total          adduct formation, cross-link formation and excision deoxyribonucleic acid (DNA)          responses. Compare these parameters in cells from the same patient after treatment with          oxaliplatin in combination with fludarabine and Ara-C.   "
198984|NCT00452387|"     The purpose of this research study is to determine if the combination of mitoxantrone,     prednisone and sorafenib will improve the time to progression of advanced stage metastatic     hormone-refractory prostate cancer.   "
198985|NCT00452400|"     The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL     inhalation solution delivered by the Respimat® inhaler for four weeks in patients with     chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be     based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and     pharmacokinetic evaluations (the amount of the medication found in your blood).   "
198986|NCT00452413|"     Phase I: A study to see what doses of Enzastaurin and Erlotinib are best tolerated by     participants with solid tumor cancer.      Phase II: A study to see how long participants with non-small cell lung cancer (NSCLC)     treated with Enzastaurin and Erlotinib live.   "
198987|NCT00452426|"     Patients routinely receive sedation during a colonoscopy or upper endoscopy     (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during     these procedures. The purpose of this study is to determine if this CAPS device enables a     physician/registered nurse (RN) team to safely and effectively administer propofol sedation     during colonoscopy or EGD procedures relative to current sedation practices.   "
198988|NCT00452439|"     The goal of this clinical research study is to learn if Actonel (risedronate) can help to     prevent the development of osteoporosis (brittle and weak bones) caused by the steroid     medication used to treat leukemia. The safety of this treatment in patients with ALL or LL     will also be studied.   "
198989|NCT00452452|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of a     13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not     previously been immunized with Pneumococcal vaccine.   "
198990|NCT00452465|"     Hypothesis: It is hypothesized that older adults who receive the ElderCare intervention will,     when compared with a control group of older adults show a significant improvement in quality     of life,a significant decrease in symptomatology, significantly higher satisfaction with     their care, and less utilization of health care resources.      The Eldercare project involves a detailed assessment by a nurse done in the patients home,     followed by the development and delivery of a Eldercare Plan using a Goal Attainment Scaling     approach.      Outcomes include quality of life, symptomatology, satisfaction, and health care utilization.   "
198991|NCT00452478|"     The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to     patients on haemodialysis works as well as other treatments currently used to lower blood     phosphorus levels.   "
199250|NCT00455624|"     The purpose of this study is to find out if androgen deprivation therapy affects insulin,     cardiac risk factors such as cholesterol level, and body fat and muscle.   "
198995|NCT00452530|"     The purpose of this study is to learn whether apixaban prevents the development of blood     clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur     after knee replacement surgery, and to compare the efficacy of apixaban with that of     enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be     studied.   "
198996|NCT00452543|"     This is a study about treatment for people who suffer from both major depression and alcohol     abuse or dependence. The study will examine whether the addition of acamprosate to     escitalopram and behavioral interventions will improve outcomes for this population.   "
198997|NCT00452556|"     The purpose of this study is to see if sequence inversion of Intensity - modulated     Radiotherapy (IMRT) for prostate cancer, can improve the safety and deliverability of     concurrent docetaxel chemotherapy with long - term hormonal therapy. The hypothesis is that     inverting the traditional sequence of radiotherapy can delay the time to treatment - induced     bowel toxicity.   "
198998|NCT00452569|"     The primary objective is to compare the time to progression (TTP) of three daily doses of     thalidomide (100, 200 and 400 mg) with high-dose dexamethasone in relapsed refractory     multiple myeloma (MM) patients and to subsequently select the optimum thalidomide dose in     terms of median TPP and toxicity.   "
198999|NCT00452582|"     Stroke is the third leading cause of death in the United States and the leading cause of     serious long-term disability. Approximately 50% of the 750,000 people affected by stroke each     year have residual physical impairment. Treatment options for recovery are limited at this     time. Sildenafil (Viagra) has demonstrated the capability of significantly improving recovery     in several animal experiments of stroke. This study is aiming to establish the safety of     treatment with sildenafil in people with stroke with the ultimate aim of testing its     usefulness to improve recovery.   "
199000|NCT00452595|"     To evaluate the long-term safety of desvenlafaxine sustained release (DVS-233SR) during     open-label treatment of outpatients with major depressive disorder (MDD).   "
199001|NCT00452608|"     The purpose of this study is to determine whether atorvastatin can improve the inflammatory     answer in the septic patients   "
199002|NCT00452621|"     blood draw five years after booster-immunization with TBE vaccine to investigate     immunogenicity in children   "
199003|NCT00452634|"     3-Hydroxy-3-methylglutaryl CoA reductase inhibitors, commonly referred to as the statins,     have proven therapeutic and preventative effects in cardiovascular diseases. Recently, there     are emerging interests in their use as anticancer agents based on preclinical evidence of     their antiproliferative, proapoptotic, anti-invasive, and radiosensitizing properties.     Inhibition of 3-hydroxy-3-methylglutaryl CoA reductase by the statins interferes with the     rate-limiting step of the mevalonate pathway, leading to reduced levels of mevalonate and its     downstream products, many of which play important roles in critical cellular functions such     as membrane integrity, cell signaling, protein synthesis, and cell cycle progression.     Perturbations of these processes in neoplastic cells by the statins may therefore result in     control of tumor initiation, growth, and metastasis. The statins have demonstrated growth     inhibitory activity in cancer cell lines and preclinical tumor models in animals.     Simvastatin, a member of the statin family, profoundly impaired basal and growth     factor-stimulated SCLC cell growth in vitro and induced apoptosis. SCLC cells treated with     simvastatin were sensitized to the effects of the chemotherapeutic agent etoposide. Moreover,     SCLC tumour growth in vivo was inhibited by simvastatin. Therefore, the investigators will     conduct this phase II trial to evaluate the efficacy & toxicity of irinotecan/cisplatin plus     simvastatin in patients with chemo-naïve ED-SCLC.   "
199004|NCT00452647|"     The purpose of this study is to observe and analyze variation of diastolic blood pressure     measurements at third trimester of pregnancy and when they present for delivery in comparison     to healthy volunteers.      When patients present for delivery, we expect blood pressure to be lower than normal. However     this is not the case. We aim to determine where this trend occurs throughout to duration of     pregnancy, and propose possible explanation as to the source of this event.      After discharge, the information recorded includes each patient's blood pressure upon     admission to the labor floor, and several blood pressure measurements from prior clinical     visits.   "
199005|NCT00452660|"     Certain percentage of MDS patients develop iron overload. Iron is known to participate in     intracellular reactions that generate free radicals, inducing oxidative stress and apoptosis,     which was found to be increased in MDS patients and consequently resulted in ineffective     hematopoiesis. The aim of this study is to evaluate the antioxidant effect of the oral iron     chelator Deferasirox -Exjade in low risk MDS patients with iron over load by evaluating     changes in several oxidative stress parameters Certain percentage of MDS patients develop     iron overload.   "
199006|NCT00452673|"     The purpose of this study is to learn about the safety and efficacy of Dasatinib in     combination with Capecitabine for patients with advanced breast cancer, and who have received     treatment with a taxane and an anthracycline   "
199007|NCT00452686|"     This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals'     reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in     comparison with Chinese DT vaccine, in children 6-8 years of age.   "
199008|NCT00452699|"     This purpose of this study is to show the superiority and long term safety and efficacy of     adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid     (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of     asthma control will provide key information on the efficacy and safety of the combination     therapy. The safety measure will be an assessment of adverse events   "
199009|NCT00452712|"     Objective:to determent if children suffering from acute febrile illness has higher rate of     orthostatic hypotension compared with children with no febrile illness. Design: a prospective     cohort study. Subjects: children aged 4-18 year with fever (temperature > 38.) for up to 48     hours, presenting to the pediatric emergency department. Interventions: All subjects will     have their blood pressure measured in supine position (after 5 minute of rest) and after 3     minute of standing.   "
199010|NCT00452725|"     1. Clinical Objective : To improve the growth of these children        2. Genetic objective : A study of the genetics of the syndrome   "
199251|NCT00455637|"     The purpose of the study is to compare the effectiveness of 3 doses of Dysport (5, 10 or 15     Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in     children/young people.   "
199011|NCT00452738|"     The objective of this study is to examine the effects of pre surgery dog visits as compared     to a costumed character or parents-only on the consumption of pain medication after surgery.     It is hypothesized that pre surgery dog visits will reduce post surgical stress and anxiety.   "
199012|NCT00452751|"     The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric     cancer in comparison with open gastrectomy.   "
199013|NCT00452764|"     Lymphoid follicles, consisting of T-and B cells, are involved in the chronic inflammatory     response in COPD. Foxp3 positive regulatory T cells (Tregs) are present in these follicles     and may be involved in the suppression of this chronic inflammatory response.      We hypothesise that a dysfunction of Tregs underlies the development of the inflammatory     response in COPD. This could be either due to a decreased presence of Tregs in COPD, or to an     altered function of Tregs possibly caused by a decreased HO-1 expression and/or an altered     TGFβ regulation.   "
199014|NCT00452777|"     The purpose of this study is to evaluate the efficacy and tolerability of BVT.115959 in     diabetic patients with neuropathic pain who are either not on analgesia or are on stable     analgesia in the month prior to entering the study.   "
199015|NCT00452790|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of a     13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given     concomitantly with routine paediatric vaccinations in India.   "
199016|NCT00452803|"     It is suggested that a bimodal or trimodal approach combining neoadjuvant chemotherapy with     or without radiotherapy followed by surgery provides a potentially superior method of     enhancing resectability and improving locoregional control and survival compared to     radiotherapy alone followed by surgery. Unsolved questions are the identification of the best     induction strategy, the impact of surgery on long-term survival, and the contribution of     radiation therapy in this setting. Thus, the investigators conduct a phase II trial to     compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with biopsy     proven N2 stage IIIA NSCLC to address optimal induction strategy.   "
199017|NCT00452816|"     The objective of the project is to understand how best to help mid-size employers adopt     evidence-based chronic disease prevention practices that improve employee health behaviors.   "
199018|NCT00452829|"     The aim of the study is to develop a randomised, double blind clinical trial to compare (i)     folic acid plus inositol, with (ii) folic acid plus placebo, for prevention of recurrent     neural tube defects.   "
199019|NCT00452842|"     An observational safety follow up trial will be conducted to monitor the occurrence of     cardiovascular events and all cause mortality in subjects who participated in selected     torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials. No hypotheses will be tested.   "
199020|NCT00452855|"     The purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is     similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.   "
199021|NCT00452868|"     RATIONALE: Donepezil may decrease the side effects caused by radiation therapy to the brain.      PURPOSE: This clinical trial is studying how well donepezil works in treating young patients     with primary brain tumors previously treated with radiation therapy to the brain.   "
199022|NCT00452881|"     Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and     a lower incidence of hematological and gastrointestinal toxicities. The combination of     gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic     index. Given the potential advantages of oxaliplatin and th finding that the addition of     chemotherapy improves survival in the postoperative adjuvant setting, we conduct a phase II     trial to compare adjuvant gemcitabine-oxaliplatin with gemcitabine-cisplatin in patients with     completely resected stage IB, II or IIIA NSCLC   "
199023|NCT00452894|"     This study is to measure how much of varenicline tartrate is in Chinese healthy smokers'     blood and urine after taking a single dose and several doses respectively, and also to test     the safety (the impact of the study drug on Chinese healthy smokers' body) of varenicline.   "
199024|NCT00452907|"     Test the hypothesis that repeated administration of Artesunate/Amiodaquine,     Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of     consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated     falciparum malaria and malaria attributable anemia   "
199025|NCT00452920|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells.     Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together     with radiation therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when     given together with radiation therapy and to see how well they work in treating patients with     stage II, stage III, or stage IV cervical cancer.   "
199026|NCT00452972|"     This study was undertaken to compare the two techniques (exteriorized vs in situ) of uterine     repair with respect to patient comfort, hemodynamic changes, surgical time and blood loss, in     patients undergoing elective CD under a strictly standardized spinal anesthetic. We     hypothesized that in situ uterine repair would be more comfortable for the patients.   "
199027|NCT00452985|"     Primary objective:      To assess response rate. To record the clinical improvement in relation to stage and     histopathological grading.      Secondary objective:      To determine progression free survival. To find out overall survival. To evaluate the safety     of the study regimen.   "
199028|NCT00452998|"     Sequential Laser Iridotomy uses argon and Nd:yag laser in the first and second steps,     respectively. Using q-switched 532 nm laser in the second step is hypothesized to be as good     and effective as the conventional Nd:yag laser, because it selectively targets pigmented     cells and delivers a short pulse duration of 3 nanoseconds, causing less thermal and     collateral damage.   "
199071|NCT00453570|"     As per request by the Heath Authorities, the present clinical study will assess the     immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™)     as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age     followed by a booster dose at 18-20 months of age as compared to commercially available     DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet     the requirements for registration of the product in People's Republic of China.   "
199029|NCT00453011|"     Objective: The standard definition of failure in cataract surgery is best corrected visual     acuity of less than 20/40 at one year. The specific aim of this cooperative study was to     compare the failure rate for those patients with vitreous loss in whom an PC IOL is placed to     the failure rate for those in whom an AC IOL is placed after vitreous loss.      Design: A total of 437 patients in 15 centers were randomized to AC or PC IOL over a 45-month     period and were followed for a minimum of one year. The null hypothesis is that the rate of     failure is the same in the two groups.      All patients who were about to undergo cataract surgery in the participating centers and who     did not meet an exclusion criterion were eligible for the study. At the time of surgery, if     there was vitreous loss, and if in the opinion of the surgeon there was sufficient capsular     support for a posterior chamber lens to be placed, then the patient was randomized into one     of either the anterior or posterior chamber lens groups. The patients were then followed for     complications (e.g., retinal detachment, cystoid macular edema, uveitis, glaucoma, hyphema)     and for the primary end point of visual acuity of 20/40 or better at one postoperative year.      An Index Group of about 500 patients without vitreous loss also were followed according to     study protocol. These patients were compared to those in the PC and AC IOL groups with     respect to outcome and baseline characteristics in order to assess the effect of vitreous     loss on complication rates.      All patients were followed at annual intervals until the termination of the study. This     allowed the study to obtain long-term information with regard to visual acuity and     complication rates.   "
199030|NCT00453024|"     When implanting an Ahmed glaucoma tube, a scleral flap is usually created to cover the tube,     and the conjunctiva is stitched back in place with nylon 10-0 sutures. It is hypothesized     that an equally safe or better method is using a bovine pericardial patch graft that can be     secured in place over the tube with tissue glue, and using tissue glue to reposition the     conjunctiva in place.   "
199031|NCT00453037|"     The purpose of this study is to evaluate the effects of a structured educational program for     hypertensive patients. The program was developed at the University of Dusseldorf, Germany.     The contents of the program are as follows: teaching of the background of hypertension,     techniques of self estimation of blood pressure, life style and dietary habits, some     information concerning the different pharmacological properties to treat hypertension   "
199032|NCT00453050|"     RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in     different ways and stop tumor cells from growing. Laser therapy uses light to kill tumor     cells. Giving imiquimod together with laser therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects of imiquimod and laser therapy with     or without a green dye in treating patients with stage III or stage IV melanoma that has     spread to other parts of the skin.   "
199033|NCT00453063|"     This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS)     once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in     reducing the total nasal symptom score and the total ocular symptom score.   "
199034|NCT00453076|"     The primary goal is to determine stent patency and overall survival of the conventional     covered self expandable metallic stent versus paclitaxel eluting covered self expandable     metallic stent in unresectable malignant bile duct stricture.      The secondary goals are to assess reinterventions, complications, technical difficulties, and     physician graded ease of placement and to assess toxicity of paclitaxel eluting covered self     expandable metallic stent.   "
199035|NCT00453089|"     To conduct a prospective, randomized, blinded, placebo controlled, dose escalation clinical     trial in 4 cohorts of 10 postmenopausal women (total N=40) aged 45 to 65 years with at least     one menopausal vaginal symptom, vaginal pH > 5.0 and > 20% parabasal vaginal epithelial     cells.   "
199036|NCT00453102|"     Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).   "
199037|NCT00453115|"     Oxaliplatin is a diaminocyclohexane platinum compound, with a mechanism of action similar to     that of cisplatin. Oxaliplatin has a more manageable toxicity profile than cisplatin, with no     renal toxicity and a lower incidence of hematological and gastrointestinal toxicities.     Gemcitabine and oxaliplatin are both active in NSCLC with no overlapping toxicity.     Preclinical studies show a synergistic effect of the gemcitabine-oxaliplatin combination. The     combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the     therapeutic index.   "
199038|NCT00453128|"     The purpose of this study is to determine whether thorough analytical evaluation is useful to     diagnose metabolic conditions associated to calcium pyrophosphate deposition disease.   "
199039|NCT00453141|"     The purpose of this study is to determine if there may be a benefit to the newborn if     betamethasone is given 12 hours apart instead of 24 hours apart.   "
199040|NCT00453154|"     This partially randomized phase I/II trial studies the side effects and best dose of     sunitinib malate and to see how well it works when given together with cisplatin or     carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer.     Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether     cisplatin or carboplatin and etoposide are more effective when given with or without     sunitinib malate in treating small cell lung cancer.   "
199041|NCT00453167|"     As a single agent, paclitaxel has a response rate of 33% and 25-29% in SCLC patients with     sensitive relapse and with resistant relapse, respectively. As a single agent, gemcitabine     also has a response rate 16% and 6-13% in SCLC patients with sensitive relapse and with     resistant relapse, respectively. Because of single-agent activity, different mechanism of     action, non-overlapping toxicities, and beneficial pharmacologic interaction, paclitaxel and     gemcitabine combinations are attractive for testing in clinical trials.   "
199042|NCT00453180|"     The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC)     will improve behavior problems often associated with autism spectrum disorders.   "
199043|NCT00453193|"     The goal of this clinical research study is to learn if giving pentostatin with alemtuzumab     can help to control T-cell malignancy. The safety of this combination therapy will also be     studied.   "
199044|NCT00453206|"     RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor     peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or     abnormal cells. It also helps stop the patient's immune system from rejecting the donor's     stem cells. When the healthy stem cells from a donor are infused into the patient they may     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and     platelets. Sometimes the transplanted cells from a donor can make an immune response against     the body's normal cells. Giving tacrolimus, methotrexate, mycophenolate mofetil, and     antithymocyte globulin before and after transplant may stop this from happening. Once the     donated stem cells begin working, the patient's immune system may see the remaining cancer or     abnormal cells as not belonging in the patient's body and destroy them (graft-versus-tumor     effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may     boost this effect.      PURPOSE: This phase II trial is studying how well donor stem cell transplant works in     treating patients with hematologic cancer or other diseases.   "
199045|NCT00453219|"     Functional Hypothalamic Amenorrhea (FHA), the spontaneous cessation of the menstrual cycle     for at least 6 months after menstrual cyclicity has been established, is a common and     reversible form of anovulation not due to discernible organic causes. Whereas animal studies     suggest an interaction of metabolic and psychosocial stress in the genesis of FHA, the     distinct central mechanisms in humans are not clear. On a behavioral level, FHA appears to     depend on a complex interplay between individual stress susceptibility, stressful life     events, and enduring metabolic challenge due to inappropriate attitudes towards eating and     body image. We will use a comparison group of ovulatory, eumenorrheic women (EW) and a     contrast group of lean women with polycystic ovary syndrome (PCOS). Although women with FHA     and PCOS present with anovulation, each condition differs markedly in pathobiology (and     health burden). Contrasting women with FHA to those with PCOS will afford an opportunity to     understand more about the interaction between metabolism, stress, and reproduction and to     determine the extent to which differences between FHA and EW are attributable to reproductive     compromise (anovulation) per se versus specific to the pathogenesis of FHA or PCOS. We have     used this approach to great advantage in the past to show that hypercortisolemia was confined     to FHA and not PCOS (Berga 1997) and that dysfunctional (unrealistic) attitudes and decreased     coping skills were reported more often in FHA than in PCOS and more in PCOS than EW. Further,     this approach of comparing 3 groups will allow us to improve therapeutic approaches for two     principle causes of anovulatory infertility in women. To accomplish this, we will study women     with FHA, PCOS, and normal ovulatory women. The study will take place over 2 months and women     will make 4-5 outpatient visits to the Clinical Integration Network Center and will have one     overnight stay for frequent blood sampling.   "
199046|NCT00453232|"     RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the     number of immune cells found in bone marrow or peripheral blood and may help the immune     system recover from the side effects of chemotherapy. Giving combination chemotherapy     together with pegfilgrastim may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving combination     chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell     tumors.   "
199047|NCT00453245|"     To examine the clinical genetic and biochemical characteristics of children with growth     hormone deficiency.   "
199048|NCT00453258|"     The significance of our study is in the importance of understanding the quality and quantity     of proteins in the human tear film from diseased and non-diseased patients. This pilot study     will provide data to plan prospective research to better delineate the utility of tear     proteins in diagnosing and following disease status in a non-invasive fashion.   "
199049|NCT00453271|"     The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and     effective in the treatment of distal subungual onychomycosis of the toenail.   "
199050|NCT00453297|"     This Phase I trial in healthy, post-menopausal women is designed as a double-blind,     placebo-controlled, randomized, ascending single-dose safety trial. MF101 will be     administered as a single oral dose to a total of 32 enrolled subjects between the ages of     40-65 years. Eight subjects will be assigned to each of four cohorts. Within each cohort, six     subjects will be randomized to receive MF101 and two subjects will receive placebo. MF101     doses will be incrementally escalated until the stopping criteria are reached. If stopping     criteria are reached before the fourth cohort receives dosing, the next cohort may receive a     dose between the dose that was administered to the cohort exhibiting symptoms of MF101     toxicity and the next lower dose group.   "
199051|NCT00453310|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with     metastatic germ cell tumors that have relapsed or not responded to treatment.   "
199052|NCT00453323|"     Capecitabine is an orally administered fluoropyrimidine that is converted by 5-FU by     thymidine phosphorylase (TP), preferentially in tumor tissues and has demonstrated activity     as single agent in patients with gastrointestinal cancer. Up-regulation of TP after taxane     treatment in vitro suggested that there may be synergistic effects in combined treatment with     taxane and capecitabine. The combination of taxane and capecitabine was reported to be highly     active against non-small cell lung cancer, breast cancer, and stomach cancer.   "
199053|NCT00453336|"     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a     certain kind of light. When the drug is active, precancerous cells and cancer cells are     killed.      PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy     with porfimer sodium works in treating patients with precancerous lesions, cancer, or other     disease of the aerodigestive tract.   "
199054|NCT00453349|"     To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus     oral metronidazole in uncomplicated pelvic inflammatory disease (PID)   "
199055|NCT00453362|"     This is a single-arm, open-label, multicenter, international pilot study to evaluate changes     that occur in 2-deoxy-2-[18F]fluoro-D-glucose (FDG)- and     3'-deoxy-3'-[18F]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result     of treatment with erlotinib in patients with recurrent or refractory non−small cell lung     cancer (NSCLC). The study will enroll approximately 30 patients at approximately 4 sites in     Australia and 2 sites in the United States.   "
199056|NCT00453375|"     The purpose of this study is to determine the safety of BHT-3021 injections given weekly for     12 weeks and to evaluate the effect of BHT-3021 on antibody and immune (T cell) responses to     autoantigens (e.g. insulin). Changes in pancreatic beta cell function, insulin requirements     and blood glucose levels will also be evaluated.   "
199057|NCT00453388|"     This phase II trial studies how well total-body irradiation (TBI) works when given together     with fludarabine phosphate and cyclophosphamide followed by donor bone marrow transplant,     mycophenolate mofetil, and cyclosporine in treating patients with Fanconi anemia (FA). Giving     low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and TBI before     or after a donor bone marrow transplant helps stop the growth of abnormal cells. It may also     stop the patient's immune system from rejecting the donor's stem cells. The donated stem     cells may replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving mycophenolate mofetil and     cyclosporine after the transplant may stop this from happening.   "
199058|NCT00453401|"     Purpose of this study is to determine the safety and efficacy of topical applications of     NB-001 as compared to placebo for the treatment of recurrent herpes labialis.   "
199059|NCT00453414|"     The purpose of this study is to evaluate the safety and effectiveness of iloprost for PAH in     children who are between the ages of 3 and 18 years old.   "
199060|NCT00453427|"     The primary objectives of this study are to:        1. establish the safety and dose limiting toxicities of combining alemtuzumab with CHOP          chemotherapy for patients with newly diagnosed aggressive T-cell lymphomas; and        2. to measure the pharmacokinetics of alemtuzumab used in different subcutaneous doses and          schedules.      This will then determine the dose with the highest achievable drug levels with acceptable     toxicities worthy of further investigation.      The secondary objectives are to:        1. establish the efficacy of combination alemtuzumab with CHOP chemotherapy; and        2. to measure the effects of combination alemtuzumab with CHOP chemotherapy on T-cell          reconstitution and cytomegalovirus (CMV) reactivation.   "
199061|NCT00453440|"     This is a study to determine the prevalence of a genetic marker, HLA-B5701, in the UK     population. HLA-B*5701 has been strongly associated with the risk of an allergic reaction to     a HIV medicine, Abacavir. The allergic reaction is known as a hypersensitivity reaction.      The study is a prospective study inviting HIV-1 positive patients over the age of 18 years to     participate. Each participant will complete one study visit. They will be asked for details     of their background including their age, sex, ethnicity, country of origin and parental     country of origin.      They will be asked to give two samples to test for the presence of the genetic marker     HLA-B*5701. The two samples are:        -  A cheek swab        -  A blood sample      In selected centres patients may be asked to provide up to two additional blood samples.     These samples will be used to help develop and validate new methods of determining HLA-B*5701     testing.   "
199062|NCT00453453|"     The investigators hypothesize that patients admitted to an emergency department (ED)     observation unit will have a decreased rate of hospital admissions and ED recidivism when     treated with nesiritide versus standard therapy. The investigators also hypothesize that     decreasing B-type Natriuretic Peptide (BNP) levels during treatment in an ED observation unit     will predict improved patient outcomes.   "
199063|NCT00453466|"     Intimate partner violence against women is a significant global health problem. This study     was designed to test the hypothesis that a group intervention based on empowerment theory of     Paolo Freire would be effective as a means to reduce the extent and prevent violence among     women whose partners were violent toward them.   "
199064|NCT00453479|"     GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being     developed for the treatment of chronic obstructive pulmonary disease. This is a randomised,     double-blind, placebo-controlled, dose ascending, parallel group study to examine the safety,     tolerability, pharmacokinetics and pharmacodynamics of twice daily inhaled doses of     GSK233705B for 7 days, in COPD subjects.   "
199065|NCT00453492|"     The primary objective is to compare subject satisfaction of once a week dosing of 35 mg     Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.      The secondary objectives are to measure compliance (50 % drug taken), and persistence, [and     urinary NTx (N-telopeptides) (optional)].   "
199066|NCT00453505|"     Objectives      Noninvasive stimulation of the central and peripheral nervous system, including transcranial     magnetic stimulation (TMS), theta-burst TMS (TBS), transcranial direct current stimulation     (tDCS) and cutaneous/peripheral nerve stimulation (CPNS) alone or paired with TMS (paired     associative stimulation, PAS), has been increasingly used in the investigation of cortical     plasticity and as a possible adjuvant strategy in neurorehabilitation. It has been shown that     TMS, TBS, tDCS and CPNS can successfully modulate motor function in healthy volunteers, as     well as in patients with neurological disorders such as stroke.      One fundamental problem is that the optimal parameters of stimulation to modulate motor     function by all of these techniques are not known. The purpose of this protocol is to explore     within safe guidelines, the effects of different stimulation parameters on motor cortical     function, on oscillatory brain dynamics measured with magnetoencephalography (MEG) and     electroencephalography (EEG), on eye movements, and on fMRI activation. In addition, this     protocol will be used to train new fellows coming to NINDS Human Cortical Physiology Section     (HCPS) in the use of TMS, TBS, tDCS, and CPNS techniques.      We expect that information emerging from these studies will allow us to 1)optimize the     stimulation parameters to collect pilot data in healthy volunteer for future patient-oriented     hypothesis-driven protocols,2)to collect pilot data for power analysis for future     patient-oriented hypothesis driven protocols, and 3) to train new fellows in the use of these     different methods.      Study Population      Up to 1000 healthy volunteers, age 18 and older.      Design      Healthy volunteers will receive one or more of the following types of stimulation alone or in     combination: (1) 1 Hz TMS for up to 30mins and up to 115% of resting motor threshold     intensity (MT). These parameters are not being used for single-pulse TMS and paired-pulse     TMS. Parameters for single-pulse TMS and paired-pulse TMS are variable as they depend on the     sub-study. For paired pulses, duration of each TMS pulse is up to 1 msec. Interval between     pulses is up to 20 sec and intensity of stimulation is up to 100 % of stimulator s output     depending on the sub-study. (2) TBS below 100% active MT; (3) tDCS up to 2 mA for up to     60mins (4) CPNS with intensities below 130% of the peripherally-elicited-motor-threshold for     up to 2 hours. All of these parameters of stimulation and procedures have safely been used as     previously reported in the literature. Sham stimulations will be delivered for each modality.      Each subject may undergo up to 20 sessions spaced by at least one day, depending on the     particular exploration. To verify that the number of sessions per subject does not exceed 20     sessions, the number of sessions per participant is tracked across substudies using CTDB. The     AIs are responsible for entering into CTDB the subjects/visits. We will test the effects of     these different forms of stimulation on motor cortical excitability, simple motor tasks, and     functional neuroimaging measures. Some stimulation may be conducted before, after, or during     fMRI scans, eye movement recording, MEG and/or EEG recording sessions. To identify the     possible contribution of sub-cortical structures, we will also measure M-wave, F-wave, and/or     H-Reflexes. The goal of these exploratory studies is to obtain preliminary information on the     effects of these various combinations of central and peripheral nervous system stimulation     that would allow us to develop subsequent, finely tuned, hypothesis-driven protocols.      Under this protocol, we conduct:      Exploratory Sub-studies. These substudies are exploratory in nature and are conducted in     order to develop information to generate better informed hypotheses and/or power analyses. We     have set an upper limit of 40 subjects per sub-study.      Hypothesis-Testing Sub-studies. Hypothesis-testing sub-studies are studies with specific     hypotheses to be tested. These sub-studies undergo statistical and PIRC review after 6     subjects per group (e.g., after 12 subjects, 6 per arm, if two groups are studied), before     additional subjects can be recruited. Together, the P.I. and PIRC will decide whether to     continue the sub-study with more subjects without an amendment or whether an amendment or     protocol would be necessary. A memo requesting a review of hypothesis-testing sub-studies for     possible additional enrollment (beyond 6) will be sent to PIRC and the statistical reviewer.      In addition to the sub-study types above, this protocol is used to train new investigators     and optimize various techniques and experimental approaches (e.g., appropriate MRI sequences,     parameters of TMS stimulation, behavioral training duration).      We devised a strategy to ensure that a sub-study engages only procedures authorized in     protocol and consent form and is scientifically valuable. F...   "
199067|NCT00453518|"     This is a multicenter, prospective study designed to demonstrate the performance and safety     of the FiberNet Embolic Protection System when used as an adjunctive device during saphenous     vein graft (SVG) intervention.   "
199068|NCT00453531|"     This study will develop a model system that can be used to test medications for improving the     ability of blood vessels to resist damage from diseases such as heart attack and stroke. The     endothelium (inner layer of blood vessels) has built-in defense mechanisms to prevent     blockage of blood flow, including the ability to stretch the vessel when it senses that blood     flow is threatened. People with heart attack risk factors, such as high cholesterol, smoking     and diabetes lose this ability. This study will develop a model that can measure the response     to a lack of blood flow in the arm and be used to test new medicines to improve blood vessel     health.      Healthy males between 18 and 45 years of age who have no history of high blood pressure, high     cholesterol, or diabetes and who have not smoked for at least 3 months before entering the     study may be eligible to enroll.      Participants lie in an adjustable reclining bed. Small catheters (tubes) are placed in the     artery and vein of the forearm of the non-dominant arm at the inside of the elbow. Blood     samples are collected from the tubes. Then, pressure cuffs are placed on both wrists and     upper arms. A strain gauge (rubber band-type device) is placed around the forearms. The     pressure cuffs are inflated and blood flows into the forearm, stretching the strain gauge at     a rate proportional to the blood flow. Then, small doses of acetylcholine (a medicine that     causes blood vessels to expand) are injected into the artery tube. After 20 minutes, blood     flow to the non-dominant arm is blocked by inflating the pressure cuff. The subject squeezes     a rubber ball about every 2 seconds for 90 seconds. The cuff is deflated after 15 minutes and     blood samples are withdrawn from the tube in the vein. After 15 minutes, the procedure is     repeated one more time.   "
199069|NCT00453544|"     The purpose of this study is to evaluate the efficacy of an enhanced consent procedure for     patients with mild-to-moderate Alzheimer disease, and to identify factors and patient     characteristics that predict the degree to which enhanced consent is more beneficial than     routine consent procedures.   "
199070|NCT00453557|"     Growth hormone treatment in humans has been shown to decrease body fat. This study aims to     determine what adipose tissue depots are affected by GH and what is the mechanism.   "
199072|NCT00453583|"     This is a non-interventional retrospective data collection study from children aged from 2 to     12 years old diagnosed with an allergy and who received a treatment consisting of an     H1-antihistamine. The period of last taken medication will be observed to evaluate the global     satisfaction of the parents and physician for this last treatment.   "
199073|NCT00453596|"     Impaired endometrial growth (thin endometrial thickness) is a critical factor for     implantation failure. In this study, effects of vitamin E on endometrial growth are studied.   "
199074|NCT00453609|"     The overall goal of this project is to improve the treatment of alcohol dependence in     patients with serious mental illness (SMI). SMI for this study is defined as any patient with     any of the following diagnoses: schizophrenia, schizoaffective disorder, and bipolar type I     or type II disorder. Alcohol and other substance use disorders (SUDs) are common among     individuals with SMI. SUD comorbidity is associated with many adverse consequences. However,     to date, few reports have addressed the efficacy of pharmacological treatments for SUDs in     this population. Naltrexone pharmacotherapy is an effective treatment for alcohol dependence,     but it has not been systematically applied to the care of patients with SMI. The primary aim     of this study is to determine the feasibility of long-acting injectable naltrexone     administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol     dependence. Secondary aims include providing a preliminary assessment of the tolerability and     safety of long-acting injectable naltrexone in patients with SMI who also have a diagnosis of     alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy     of long-acting injectable naltrexone in reducing alcohol use from baseline levels.   "
199075|NCT00453622|"     The purpose of the study is to identify if the combined use of cardiac troponin enzyme (cTnT)     and brain natriuretic peptide (BNP) can predict Heart Failure (HF)improvement and all-cause     mortality in patients implanted with cardiac pacemaker-defibrillation devices (CRT-D). Novel     biochemical markers identifying patients with high risk cardiac mortality detected by plasma     protein analysis will also be evaluated.      Hypothesis #1: The combined use of cTnT and BNP at just before implant will predict and risk     stratify all cause mortality or HF hospitalization up to 12 months.      Hypothesis #2: The change in levels of said biomarkers at different points of follow-up can     predict response to CRT through 12 months.      Hypothesis #3: The levels of a panel of novel inflammatory mediators, namely chemokines, will     be correlated with improvement in 6-minute walk testing, quality of life, and left     ventricular ejection fraction in CRT patients.   "
199076|NCT00453635|"     This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin     and Herceptin versus the administration of Vinorelbine and Herceptin combination as first     line treatment in HER-2 positive patients with metastatic breast cancer.   "
199077|NCT00453648|"     The primary purpose of this study is to determine whether daily consumption of orange-fleshed     sweet potatoes increases the vitamin A status of Bangladeshi women of reproductive age.     Secondary purposes of the study are to determine whether consumption of orange-fleshed sweet     potatoes has an effect on the intestinal absorption of dietary iron or dietary zinc in     Bangladeshi women of reproductive age.   "
199078|NCT00453661|"     The goal of this behavioral research study is to improve the use of cancer prevention     services, increase early detection, and treatment of cancer. A secondary outcome of this     demonstration project proposes that a structured patient navigator (PN) will reduce the cost     of Medicare services.   "
199079|NCT00453674|"     Basic objective of the German Adrenocortical Carcinoma Registry is to improve the care of     patients with adrenocortical cancer. The registration of as many patients as possible helps     to collect data for the prognosis and prospects of success regarding different treatment     plans. This data will be taken into consideration for planning prospective studies. With this     registry, the recruitment of patients for prospective studies will be significantly     facilitated. In this way - and in cooperation with networks in other countries (e.g. in Italy     and France) - a structure allowing systematic improvement of therapy will be developed.   "
199080|NCT00453687|"     This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a     new formulation.   "
199081|NCT00453700|"     Chagas disease is endemic to the Americas, infecting between 16-18 million individuals. In     immigrant populations in the United States from endemic areas, it is estimated up to 4.9% may     be asymptomatic carriers of Trypanosoma cruzi, the organism which causes Chagas disease.     Between 10-20% of these patients progress to development of end-stage cardiomyopathy with a     high associated morbidity. Following acute disease, patients enter into an indeterminate     phase which can last 10-20 years. The earliest sign of cardiac involvement usually is     electrocardiogram abnormalities. The most common abnormality is right bundle branch block     (RBBB), followed by left anterior fascicular block (LAFB), and left bundle branch block     (LBBB). Recent studies have shown that treatment of patients at this stage with     antiparasitics may delay the progression of overt cardiomyopathy.      At the University of California, Los Angeles, there is a large population of immigrant     patients from countries endemic to Chagas disease. The researchers propose that screening     patients with conduction abnormalities on electrocardiogram may be a potentially useful     method to identify patients with early cardiac manifestations of Chagas disease. The     researchers hope to enroll approximately 300 individuals with RBBB, LAFB or LBBB on     electrocardiogram to determine the incidence of Chagas disease in this patient population.   "
199082|NCT00453713|"     The purpose of this study is to identify factors that contribute to higher mortality rates     among blacks and Hispanics with diffuse parenchymal lung disease.   "
199083|NCT00453726|"     The purpose of the study is to evaluate variation of BNP in non invasive mechanical     ventilated patients with severe acute respiratory failure.   "
199084|NCT00453739|"     The objective of this observational study is to obtain long -term clinical and patient     reported outcomes on the use of the GYNECARE family of TVT (Tension-Free Vaginal Tape)     systems in women with stress urinary incontinence.   "
199085|NCT00453752|"     The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in systemic sclerosis     patients and to establish whether it reflects the severity of RV overload.   "
199086|NCT00453765|"     The purpose is to determine whether montelukast during 6 weeks has superior antitussive     effects (measured with the LCQ) compared with placebo in patients with cough lasting > 8     weeks and enhanced bronchial hyperreactivity.   "
199087|NCT00453778|"     Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced     bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where     patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments.     Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of     each treatment period and on treatment days 13 and 14 respectively.   "
199088|NCT00453791|"     This study will be the First Time in Human Study (FTIH) aiming to assess the safety and     tolerability of GW805858 for both single and repeat dose. The study also aims to assess     safety and tolerability in mild asthmatic subjects as well as healthy volunteers.   "
199089|NCT00453804|"     The primary aim of this study is to determine the feasibility of long-acting injectable     naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis     of alcohol dependence. Secondary aims include providing a preliminary assessment of the     tolerability and safety of long-acting injectable naltrexone as compared with oral naltrexone     in patients with SMI who also have a diagnosis of alcohol dependence. An additional aim is to     provide a preliminary assessment of the efficacy of long-acting injectable naltrexone as     compared with oral naltrexone in reducing alcohol use from baseline levels   "
199090|NCT00453817|"     The primary objective of this pilot study is to assess the feasibility and safety of ex vivo     islet labelling prior to intraportal transplantation in patients with type 1 diabetes with     the purpose of islet graft imaging. The secondary objective is to determine the usefulness of     this method for long-term islet graft monitoring.   "
199091|NCT00453830|"     Aim: This is a prospective, randomized comparison of traditional open (OS) and laparoscopic     sigmoidectomy (LS) in patients with complicated diverticular disease. The study is designed     in order to minimize bias by standardizing the two procedures and blinding patients and     nurses during the preoperative and early postoperative period.      Hypothesis: A laparoscopic approach for sigmoidectomy has significant advantages over the     open technique with respect to postoperative pain, duration of ileus, length of hospital     stay, and perioperative morbidity.      Methods: Patients with complicated diverticular disease who are candidates for elective     sigmoidectomy will be randomized the day before surgery, and anaesthetic technique and     postoperative management will be standardized between groups. Surgeons with experience in     both laparoscopic-assisted and open colectomy will perform both types of procedures. At the     end of the operation, identical, opaque wound dressings will be applied and left in place     until postoperative day 4. Both patients and nursing staff will therefore be blinded to the     type of surgical technique during the early postoperative period.      Endpoints:      A) Postoperative pain assessed by the Visual Analog Scale at postoperative days 1, 2, and 3.      B) Postoperative intake of systemic opiates (morphine)      C) Duration of postoperative ileus, quantified by the interval in hours between the end of     the procedure and passage of first stool.      D) Duration of hospital stay.      E) Surgical complications, such as wound infection, anastomotic leakage, bleeding      F) General medical complications, such as cardiopulmonary, pneumonia, and renal failure.      Rationale: This study will determine whether a laparoscopic sigmoidectomy is associated with     significant clinical advantages over the traditional open approach when patients with     complicated diverticular disease are blinded to the operative technique.   "
199092|NCT00453843|"     We will test on persons with chronic impairment due to stroke:        1. whether the order in which robot therapy is delivered influences outcomes          (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).        2. whether we should train the shoulder, elbow, and wrist at the same time or on different          days.   "
199093|NCT00453856|"     IPTi, a strategy whereby infants are provided treatment doses of antimalarials at routine     vaccination visits, has been shown to significantly reduce malaria and anemia in two studies     in Tanzania. However the results obtained in Gabon are not similar. Many factors are likely     to influence the efficacy or effectiveness IPTi. It is reasonable to assume that the efficacy     of IPTi will be influenced markedly by the sensitivity of Plasmodium falciparum to the     antimalarial drug (Sulfadoxine-Pyrimethamine) used for IPTi.      In order to interpret the results of individual IPTi trials conducted by the IPTi Consortium,     and to provide information for policy makers regarding the predicted efficacy of IPTi, it is     essential to obtain information on antimalarial drug sensitivity of Sulfadoxine-Pyrimethamine     now that the IPTi trial has been conducted. The simplest and most universally accepted     measure of testing for antimalarial drug efficacy is the in vivo efficacy study, which     follows a standardized World Health Organization protocol.      A second reason for evaluating drug resistance as an adjunct to the IPTi trials is to     determine if the intervention increases the carriage and/or spread of drug resistant P.     falciparum parasites.      Thirdly the overall effect at the community level of selection of resistant genotypes in     IPTi-recipients is unclear.   "
199094|NCT00453869|"     The prevalence of chronic hepatopathies is high in jail. However, the medical care of these     hepatopathies is few developed. This study is an observational, an epidemiologic (screening     and prevalence of fibrosing hepatopathies) and an evaluating study for a better taking care     of these hepatopathies in jail. The aims of the study will be to evaluate the diagnostic     performance of the FibroMeter score in the screening of the hepatic fibrosis in persons with     multiple risk factors for liver fibrosis (alcoholism, intravenous drug users, tattoo, and     virological status) with FibroScan® as gold standard; to evaluate the feasibility of these     different screening tools for chronic hepatopathies in jail and to evaluate the prevalence of     the fibrosing hepatopathies with clinically significant fibrosis and theirs risk factors,     alcohol and hepatitis B and hepatitis C viruses in population from Angers jail.   "
199095|NCT00453882|"     The objective is to evaluate the feasibility of using color Doppler ultrasound in ureteral     flow assessment after uterine artery occlusion during a conservative gynecological procedure.   "
199096|NCT00453895|"     Although a first randomized trial in patients with advanced ACC leading to the establishment     of a first line cytotoxic chemotherapy is ongoing (FIRM-ACT), the failure rate even of this     FIRM-ACT study is most likely clearly above 50%. Therefore, the majority of participating     patients urgently need a new treatment option. However, up to date there is no evidence for a     single regimen that might be promising in these treatment-refractory patients with ACC.      Sunitinib is an oral multitargeted tyrosine kinase inhibitor with anti-tumor and     antiangiogenic activities, which is successfully tested in the treatment of patients with     metastatic renal cell carcinoma, gastrointestinal stromal and neuroendocrine tumors after     failure of standard cytotoxic chemotherapy.      The primary objective of this trial is to estimate the response (defined as progression-free     survival of ≥ 12 weeks) rate associated with Sunitinib treatment in patients advanced ACC     progressing after cytotoxic chemotherapy.   "
199097|NCT00453908|"     The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin     compared to placebo, will increase the number of patients with satisfying spontaneous voiding     after acute urinary retention treated with Clean Self-Catheterization.      Furthermore is investigated the safety of the medical treatment and self-catheterization.   "
199098|NCT00453921|"     Traumatic brain injury (TBI) is a significant public health problem, with 1.5-2.0 million     Americans injured each year. Cognitive deficits, particularly in the domains of memory and     attention are frequently the source of lingering disability after TBI and a source of     enormous distress to the injured individuals and their family/caregivers. To date,     interventions to ameliorate chronic cognitive deficits have been directed at either     pharmacological interventions or cognitive rehabilitation. We propose to (1) To compare the     efficacy of three interventions: memory and attention training (MAAT), methylphenidate, and     memory/attention training in combination with methylphenidate and (2) use functional MRI     (fMRI) to characterize changes in activation of the neural circuitry of memory and attention     due to MAAT alone, methylphenidate alone, and MAAT in combination with methylphenidate. This     is a two by two design with medication (methylphenidate/placebo) and cognitive therapy     (Memory and Attention Training (MAAT) or an Attention control intervention) as possible     interventions. Using a randomized, placebo-controlled, double-blind design, 200 individuals     with persistent cognitive deficits 6-12 months after MTBI will be randomized to receive a six     week trial of either (1) MAAT and placebo, (2) MAAT and methylphenidate (0.3 mg/kg BID), (3)     attention control intervention and methylphenidate (0.3 mg/kg BID), or (4) attention control     intervention and placebo. Symptom distress, attention and memory performance, and activation     patterns of the neural circuitry of attention and memory while undergoing fMRI will be     characterized at baseline, and after the four treatment conditions. This study will provide     important information on three interventions for the most disabling sequelae of an enormous     public health problem. Further, it will help to clarify underlying neural mechanisms and     suggest additional treatment possibilities.   "
199099|NCT00453934|"     The primary objective of this study is to compare patient preference of the h-Patch as     delivery device for insulin lispro compared with either an insulin pen or needle and syringe     in patients with diabetes, either Type 1 or Type 2, on stable multiple daily injection     regimens. This will be assessed using an accepted preference scale.   "
199100|NCT00453947|"     This randomized controlled trial is primarily aimed at assessing the rate of acute myocardial     infarction with the two noninvasive ventilatory techniques, non-invasive intermittent     positive pressure ventilation and non-invasive continuous positive airway pressure.   "
199101|NCT00453960|"     The aim of this study is to verify the anti-estrogenic activity of Genistein, on the non     atypical endometrial hyperplasia, in premenopausal women.   "
199102|NCT00453973|"     The purpose of this study was to evaluate the long term safety and tolerability of     peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease     (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.   "
199103|NCT00453986|"     The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of     different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of     GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of     GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612     given alone and the immunogenicity of GSK134612 given with Fluarix™.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
199104|NCT00453999|"     This study has been designed as a randomized, double-blind, controlled, study to evaluate the     efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg)     versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute     serious or potentially life threatening influenza. Study treatments will be provided for up     to 5 consecutive days.   "
199105|NCT00454012|"     In this research project the investigators want to figure out whether ultrasound (a     non-invasive method) can be used to assess how the fetus is doing during labor.   "
199106|NCT00454025|"     Elevated intraocular pressure is widely accepted as a risk factor for glaucoma and     controlling the pressure remains the cornerstone of effective treatment. There is evidence     that posture can have a significant effect on intraocular pressure fluctuations. Salat (or     Salah) refers to the five daily prayers performed by Muslims. The time spent praying in a     kneeling or prostrate position may be associated with wide fluctuations in intraocular     pressure, potentially sight-threatening for Muslim patients with glaucoma. The researchers     seek to investigate the link between traditional daily Muslim prayer postural changes and     intraocular pressure changes.   "
199107|NCT00454038|"     The main purpose of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered     bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring     GBR.   "
199108|NCT00454051|"     The aim of this study is to evaluate the expression of IgE high affinity receptors (the part     of the cell associated with allergic response) in patients suffering from uncontrolled severe     asthma despite long term treatment with high dose of inhaled corticosteroid and long acting     Beta-2 agonist.   "
199109|NCT00454064|"     The purpose of the study:        -  to compare two cognitive-behavioral treatments   "
199110|NCT00454077|"     Most patients with differentiated thyroid carcinoma (DTC) are treated with therapeutic doses     of radioiodine (131I) after initial surgery (total or near total thyroidectomy), aimed to     destroy microscopic residual normal or tumoral thyroid cells and to facilitate the early     detection of tumor recurrence based on serum thyroglobulin (Tg) measurement and 131I whole     body scan (WBS) (1-5). Recently, preparation of patients for thyroid ablation with rhTSH and     3700 MBq of 131I on l-thyroxine (l-T4) therapy has been approved in Europe by the European     Medicines Agency (EMEA) as an alternative to thyroid hormone withdrawal (6), after a     randomized, controlled, multicenter study demonstrated that both methods of preparation are     equally effective (with 100% rate of successful ablation) and that patients prepared with     rhTSH received lower total body irradiation and experienced a better quality of life compared     to those rendered hypothyroid (7).      The present study was aimed to compare the efficacy of fixed activities of 1850 MBq versus     3700 MBq of 131I for post surgical thyroid ablation in DTC patients prepared with rhTSH     (TSHα, Thyrogen®, Genzyme Therapeutics, Cambridge, MA) on l-T4 therapy.   "
199111|NCT00454090|"     The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330     (ARRY-424704) in patients with Advanced Malignancies   "
199112|NCT00454103|"     The improvement of conventional imaging techniques has led to an increased detection rate of     different adrenal tumors. Since those tumors can belong to a variety of entities the     therapeutic consequences also show considerable variation. In order to definitely determine     the type of tumor, invasive procedures like CT guided biopsies are often required, which     could be avoided by a tumor specific imaging method. The presently available scintigraphic     procedures are either time consuming and lead to high radiation exposure or are technically     demanding. The steroidogenic enzymes CYP11B1 (11ß-hydroxylase)and CYP11B2 (aldosterone     synthase)are expressed exclusively in the adrenal cortex and therefore represent suitable     targets for a specific imaging technique. In our project we evaluate 123I-Iodometomidate     which binds to both CYP11B enzymes as radiotracer for adrenal scintigraphy.   "
199113|NCT00454116|"     The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™     (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer     in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing     regimen.   "
199114|NCT00454129|"     In patients with biliodigestive anastomosis direct cholangiography (ERC) is due to changed     anatomy commonly not possible. The aim of the study is to test the feasibility to perform     direct cholangiography in these patients via double-balloon enteroscopy and to compare it to     MR cholangiography.   "
199115|NCT00454142|"     This phase II trial studies the side effects and how well pazopanib hydrochloride works in     treating patients with stage IV or recurrent nasopharyngeal cancer. Pazopanib hydrochloride     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and     by blocking blood flow to the tumor.   "
199116|NCT00454155|"     The objectives of this study are as follows:      To demonstrate the safety of escalating doses of opebacan in subjects undergoing     myeloablative allogeneic Hematopoietic Stem Cell Transplantation      To determine the pharmacokinetics of opebacan in subjects undergoing myeloablative allogeneic     Hematopoietic Stem Cell Transplantation      To determine if IV administration of opebacan is associated with changes in biological     markers for inflammation      To develop preliminary descriptive data on the occurrence and severity of Hematopoietic Stem     Cell Transplantation related complications, including aGvHD   "
199117|NCT00454168|"     RATIONALE: Vaccines made from a peptide may help the body build an effective immune response     to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of     white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine     therapy together with GM-CSF may be an effective treatment for acute myeloid leukemia. It is     not yet known whether giving vaccine therapy together with GM-CSF is more effective than     giving placebo together with GM-CSF in treating acute myeloid leukemia.      PURPOSE: This randomized phase III trial is studying vaccine therapy and GM-CSF to see how     well they work compared with a placebo and GM-CSF in treating patients with acute myeloid     leukemia in remission.   "
199118|NCT00454181|"     This is a study to test lozenges of interferon-alpha that are dissolved in the mouth as a     treatment of oral warts in HIV-positive adults.      The hypothesis of this study is that interferon-alpha will be safe and that a higher     percentage of subjects given interferon-alpha will experience a complete or nearly complete     remission of their oral warts compared to subjects given placebo.   "
199119|NCT00454194|"     RATIONALE: Pemetrexed disodium and sorafenib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells     by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib may     kill more tumor cells.      PURPOSE: This randomized phase II trial is studying pemetrexed disodium and sorafenib to see     how well they work compared with pemetrexed disodium alone as second-line therapy in treating     patients with stage IIIB or stage IV non-small cell lung cancer.   "
199120|NCT00454207|"     To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial     hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of     sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part     1)   "
199121|NCT00454220|"     The purpose of this study is to determine the safety and effectiveness of 2 different doses     of modified-release recombinant human thyroid stimulating hormone (MRrhTSH) when administered     with radioiodine in patients with multinodular goiter, a condition that involves the     enlargement of the thyroid gland. We will also evaluate the safety and effectiveness of     radioiodine therapy alone in these patients. The goal of the treatment is to determine if     there was a reduction in the size of the goiter and to study if goiter symptoms have improved     after 6 months and after 36 months.   "
199122|NCT00454233|"     The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus     patients and to investigate whether this study drug is effective in these patients   "
199123|NCT00454246|"     This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta     (Mircera) in the maintenance of hemoglobin levels in patients who have previously received     treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic     kidney disease stage 4 through dialysis. Patients will be randomized either to receive     Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc)     Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or     darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation     of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a     starting dose based on their previous (sc) dose, and those in the control group will receive     weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the     target sample size is 500+ individuals.   "
199124|NCT00454259|"     Exaggerated pain and hyperalgesia are major issues after surgery and can lead to chronic     pain. Opioid are parts of pain sensitization processes but remain absolutely necessary in the     intraoperative period. NMDA receptor antagonists succeed in reducing this pain sensitization     process. Recent studies show that in pain and opioid-experienced rats (POER) fentanyl ultra     low doses do not induce analgesia, as observed in naive rats, but hyperalgesia. This is the     first demonstration that a drug can induce opposite effect depending on individual history.     We also observed a strong correlation between this hyperalgesic response in POER and the     intensity of hyperalgesia they develop later, after inflammatory or surgical pain. The main     aim of this study is to measure the dose effect response to fentanyl ultra low doses on     human volunteer's nociceptive threshold, to determine if such an opposite response profile     can be revealed.   "
199125|NCT00454272|"     The aim of the study is to evaluate the efficacy and safety of Teicoplanin versus Vancomycin     as part of the initial antibiotic regimen in the therapy of patients with fever and     neutropenia .   "
199126|NCT00454285|"     The major purposes of this prospective, randomized, clinical study are to:        1. Determine and compare the true incidence, nature, magnitude, and duration (INMD) of          bacteremia (bacteria found in the bloodstream) resulting from a highly invasive dental          office procedure (tooth extraction) and a minimally invasive and naturally occurring          source of bacteremia (tooth brushing);        2. Measure the effect of the American Heart Association's guidelines for amoxicillin          prophylaxis (preventive treatment) on the INMD of bacteremia resulting from a single          tooth extraction.   "
199127|NCT00454298|"     The main purpose of the study is to find out if, after 4 weeks of dosing, signs of the     investigational drug AGG-523, or its effects, can be measured in urine, blood, or the knee     joint. A secondary purpose is to evaluate the safety of taking the drug either once a day or     twice a day for 4 weeks.   "
199128|NCT00454311|"     The aim of this study is to evaluate the impact of the biopsy of one or two cells in a     preimplantatation genetic diagnosis program (PGD) for the screening of aneuploidies. This     prospective and randomized study will be performed at the Instituto Valenciano de     Infertilidad in Valencia (Spain) in those patientes included in our clinical program. Our     purpose is to optimize the methodology employed in our laboratory in order to guarantee     optimal implantation and pregnancy rates without a detrimental effect on the accuracy and     efficiency of the cytogenetic analysis. Patients will undergo and IVF cycle, embryo biopsy     will be performed on day 3 embryos in two fashions: in some patients only one cell per embryo     will be retrieved whereas in others, 2 cells will be retrieved in good morphology embryos and     only 1 in the slowl ones. In all cases aneuploidy screening will be performed by FISH for     chromosomes 13, 16, 18, 21, 22, X and Y. Embryo developmente will be checked every 24 hours     and chormosomally normal embryos will be replaced into the uterus on day 5 of development.   "
199129|NCT00454324|"     This is a phase II trial of abraxane and carboplatin in extensive stage small cell lung     cancer to examine overall response rate, time to progressive disease, survival time, and     assessment of toxicity profile for Carboplatin and Abraxane.   "
199130|NCT00454337|"     Switching from enfuvirtide to raltegravir in the treatment of HIV-infected patients who     sustain viral suppression with a combination therapy including enfuvirtide (or : with an     enfuvirtide-based combination therapy)   "
199131|NCT00454350|"     This study will measure serum levels of the active Vitamin D compound that circulates in     hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar®     (paricalcitol injection).   "
199132|NCT00454363|"     This phase II trial studies how well pazopanib hydrochloride works in treating patients with     advanced neuroendocrine cancer. Pazopanib hydrochloride may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
199133|NCT00454376|"     RATIONALE: Questionnaires that measure quality of life may help doctors identify the effects     of treatment and improve the ability to plan treatment for patients with     gastrointestinal-related neuroendocrine tumors.      PURPOSE: This phase IV clinical trial is studying how well a disease-specific questionnaire     works in assessing the quality of life of patients with gastrointestinal-related     neuroendocrine tumors.   "
199134|NCT00454389|"     The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery     of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated     with wet age-related macular degeneration (AMD). The Epi-Rad90™ Ophthalmic System treats     neovascularization of retinal tissue by means of a focal, directional delivery of radiation     to the target tissues in the retina. Using standard vitreoretinal surgical techniques, the     sealed radiation source is placed temporarily over the retinal lesion by means of a handheld     medical device.   "
199135|NCT00454402|"     The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days,     on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave     Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any     stone after 72h to 96 hours.      This study will also specifically focus on the evaluation of time of stone clearance and of     pain reduction (Numeric Rating Scale).   "
199136|NCT00454415|"     Asthma is a common illness among children in the United States. While there are many known     causes of asthma, including tobacco smoke, pollen, dust, or other allergens, the exact cause     of asthma in some individuals remains unknown. This study will examine the role that specific     dietary factors and body mass index (BMI) play in the development of childhood asthma.   "
199137|NCT00454428|"     Linear flow during cardiopulmonary bypass (CPB) frequently induces renal damage.      We will evaluate whether automatic intra-aortic balloon pump (IABP) induce pulsatile     perfusion preserves renal function in patients undergoing myocardial revascularization at     different risk for renal damage.      100 patients undergoing preoperative IABP will be stratified for renal function.      Intervention. The patients will be randomized to non-pulsatile CPB during cardioplegic arrest     or automatic IABP induced pulsatile CPB.      Renal function, daily diuretics, complication rate, lactatemia and other biochemical indices     will be compared in patients.      We will prospectively enrolle 100 patients undergoing isolated primary high-risk coronary     artery bypass grafting for severe left main stem disease (70% narrowing) or left-main     equivalent three-vessels coronary disease. On admission to our institution, the patients will     be stratified for renal function according to KDOQI and randomly assigned to Group A or Group     B. We will exclude from the study patients older than 75 years, and/or with kidney disease ≥     Stage 4 (GFR 15 – 29 ml/min/1.73 m2), and/or with other splanchnic organ comorbidities (liver     or mesenteric impairment, abdominal aortic aneurysm, abdominal arteries vasculopathy), and/or     severe autoimmune disease.      The patients randomized to Group A (n=50) will receive a preoperative IABP treatment before     induction of anesthesia, with IABP turned off during cardioplegic arrest, and restarted with     a 1:1 IABP mode immediately after cross-clamp removal (as is the traditionally adopted     perioperative IABP support); the other 50 (Group B) will receive standard preoperative     treatment with IABP, which will switche into an automatic 80 bpm mode during cross-clamp     time, and switche again into a 1:1 IABP after cross-clamp removal, in order to achieve a     pulsatile perfusion during the entire intra-operative time-course.      The patients will be stratified in 2 subgroups according to the preoperative renal function:     a subgroup will include 64 patients (32 allocated in Group A and 32 in Group B) with stage 1     or 2 [Stage 1: GFR ≥90 ml/min/1.73 m2 – Stage 2: GFR 60 - 89 ml/min/1.73 m2] and therefore     considered at lower-risk for post-CPB renal damage; the remaining 36 (18 for each group) with     KDOQI Stage 3 of kidney disease (GFR 30 – 59 ml/min/1.73 m2) will be considered at     higher-risk for perioperative renal complications [19].   "
199138|NCT00454441|"     Menopausal women often complain of difficulty sleeping and the transition from pre- to     postmenopausal status is associated with an incresase in self-reported sleep disturbance. Hot     flashes have been associated with self-reported measures of sleep disturbance and changes in     sleep pattern as measured by plysomnography, including an increase in stage 4 and a latency     or shortened time in rapid-eye movement sleep. Although there are some data on the effect of     hormone replacement therapy on self-reported sleep measures in symptomatic postmenopausal     women, there are no data on the effect of herbal extracts on subjective or objective measures     of sleep quality in this population group. Actigraphy, the use of a device to record movement     generally placed on the wrist, has been used over 20 years to provide objective data     concerning sleep/wake patterns. The advantage of actigraphy over traditional polysomnography     is that actigraphy can conveniently record continuously for 24-hours a day for longer periods     of time.   "
199139|NCT00454454|"     The purpose of this research study is to compare a virtual reality display device with the     standard neuropsychological evaluation for detecting mild cognitive impairment (problems with     memory, concentration, reaction time, etc.).   "
199140|NCT00454467|"     Total joint replacements are some of the most successful medical devices developed over the     last fifty years. They enable millions of people to remain ambulatory and pain free, with     minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements,     and 25,000 total or partial shoulder replacements were performed in the United States (HCUP     data). Future use will likely be even higher: it is estimated that by the year 2020, the     population 65 and over in developed countries will increase by 71%. Existing studies do not     provide adequate prospective data to evaluate long-term outcomes. Most health related quality     of life studies in THA and TKA only report data up to twelve months post-operatively. In     addition, most large studies of TKA and THA have been performed in Medicare patients. While     these databases are important in providing population based data, Medicare studies do not     permit any direct patient contact, and provide no information on patients under 65.      Existing studies have also investigated predictors of patient outcome at one and two years     after joint arthroplasty. However, very little is known about predictors of prosthesis     failure, and there are no validated clinical indicators for choosing one prosthesis model     over another. Once a device is FDA approved, there is very little motivation on the part of     the developer to perform complete post-marketing research, despite the importance of these     data to the public health. Most existent studies are not powered to compare differences     between models.      The purpose of this study is to establish a prospective cohort of HSS total knee     arthroplasty.   "
199141|NCT00454480|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or     carry cancer-killing substances to them. Tipifarnib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together     with gemtuzumab ozogamicin or tipifarnib may kill more cancer cells.      PURPOSE: This randomized phase II/III trial is studying different combination chemotherapy     regimens to compare how well they work when given with or without gemtuzumab ozogamicin or     tipifarnib in treating patients with acute myeloid leukemia or high-risk myelodysplastic     syndromes.   "
199142|NCT00454493|"     The purpose of this study is to investigate whether there is a difference in endothelial     function, heart rate variability and carotid intimal media thickness in patients with     coronary artery disease who are receiving fish oil therapy.      One hundred patients with established coronary artery disease by coronary angiography will     undergo randomization for enrollment in the study. Baseline evaluation will include     assessment of brachial artery endothelial function, heart rate variability and carotid     intimal media thickness. Evaluation of the endothelial function of the brachial artery will     be elucidated by inflation of a blood pressure cuff around the arm for five minutes and     measuring blood vessel dynamics after release of the cuff. Heart rate variability will be     evaluated by 24 hour holter monitoring and analysis by standard protocol. Carotid intimal     media thickness will be evaluated by ultrasound measurements guided by predetermined     protocol. Patients will then be randomized to a highly purified fish oil, Omacor, 1 gram     twice a day or placebo. Brachial artery ultrasound and holter monitoring will be repeated at     2 months. Carotid ultrasound will be repeated at the end of the study at 12 months.   "
199143|NCT00454506|"     Total joint replacements are some of the most successful medical devices developed over the     last fifty years. They enable millions of people to remain ambulatory and pain free, with     minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements,     and 25,000 total or partial shoulder replacements were performed in the United States (HCUP     data). Future use will likely be even higher: it is estimated that by the year 2020, the     population 65 and over in developed countries will increase by 71%. Existing studies do not     provide adequate prospective data to evaluate long-term outcomes. Most health related quality     of life studies in THA and TKA only report data up to twelve months post-operatively. In     addition, most large studies of TKA and THA have been performed in Medicare patients. While     these databases are important in providing population based data, Medicare studies do not     permit any direct patient contact, and provide no information on patients under 65.      Existing studies have also investigated predictors of patient outcome at one and two years     after joint arthroplasty. However, very little is known about predictors of prosthesis     failure, and there are no validated clinical indicators for choosing one prosthesis model     over another. Once a device is FDA approved, there is very little motivation on the part of     the developer to perform complete post-marketing research, despite the importance of these     data to the public health. Most existent studies are not powered to compare differences     between models.      The purpose of this study is to establish a prospective cohort of HSS total hip arthroplasty.   "
199144|NCT00454519|"     OBJECTIVES:        -  Determine response and survival of patients with peritoneal carcinomatosis treated with          cytoreductive surgery plus intraoperative peritoneal hyperthermic chemotherapy with          cisplatin and mitomycin        -  Assess the quality of life of patients treated with this regimen.      OUTLINE: Patients are randomized into IPHC group and control group. In the former group, the     patients undergo cytoreductive surgery plus intraoperative hyperthermic peritoneal perfusion     with cisplatin and mitomycin over 60 minutes. Patients in the control group just underwent     routine cytoreductive surgery.      All patients in both groups receive the standard conventional chemotherapy after surgery.      Quality of life is assessed at study initiation, at 1, 3, 6 months. Patients are followed at     4 weeks, every 3 months for 1 year, and then every 6 months for up to 3 years.   "
199145|NCT00454532|"     BZL 101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family.     Preclinical studies suggest that this herb has antitumor activity for breast cancer and     preliminary clinical data suggest that it is tolerable in patients with metastatic breast     cancer. The overall goals of this Phase I/II trial are to assess the toxicity, maximum     tolerated dose, safety and preliminary efficacy of BZL101 for the treatment of advanced     metastatic breast cancer.   "
199146|NCT00454545|"     Open pilot study to collect information regarding the effect of atorvastatin on patients with     active Crohns disease.   "
199170|NCT00447356|"     This randomized phase III trial is studying high dose interferon alfa to see how well it     works compared to observation only in treating patients with stage II or stage III melanoma     that has been completely removed by surgery.   "
199147|NCT00454558|"     This is a study to demonstrate the feasibility of an individual dose titration scheme based     on the systolic blood pressure with a dose range from 1.0 mg TID to 2.5 mg TID. Patients     suffering from chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial     hypertension (PAH) will be included. After diagnosis by an expert center, patients receive     medication three times a day starting with 1.0 mg TID. The first tablets are given in the     hospital, then the patients are allowed to go home and take the medication at home. After 2     weeks, patients return to the hospital for an ambulatory visit and the dose may be increased     based on the actual condition of the patient (blood pressure and adverse events). Several     measurements will be performed to test the efficacy of the drug and whether there are any     unwanted reactions to the drug (blood tests, ECG, 6 minute walk test, imaging by Echo,     quality of life scores). The dose of the drug will then be increased further until unwanted     effects may occur or the blood pressure drops to low. The highest dose tested will be 2.5 mg     TID. After 12 weeks the patient is going to stay in the hospital again and a right heart     catheter is performed to examine the changes in hemodynamics after 12 weeks of treatment with     the drug. If the patients give their consent they can enter a long-term extension trial     continuing on BAY63-2521 with the dose reached after 12 weeks. Every 3 months an ambulatory     visit at the specialist center will be performed including measurements of safety (blood     tests, ECG, clinical assessment) and efficacy (6 minute walk test, Borg dyspnea scale, NT-pro     BNP). Blood tests and ECG have been removed begin of 2013 as safety parameter by amendment 7;     furthermore Borg dyspnea score and NT-proBNP have been removed as efficacy parameter.      Initially the inclusion of ten patients suffering from chronic thromboembolic pulmonary     hypertension (CTEPH) or pulmonary arterial hypertension (PAH) was planned. Later on the     patient number was amended and 75 patients entered the trial.      Furthermore the trial duration was extended and a long term treatment with BAY63-2521 was     offered to the patients. Finally 68 patients moved over to the long term extension period of     the trial.   "
199148|NCT00454571|"     This randomized phase II trial is studying how well pazopanib hydrochloride works after     leuprolide or goserelin in treating patients with relapsed prostate cancer. Pazopanib     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth and by blocking blood flow to the tumor. Androgens can cause the growth of     prostate cancer cells. Antihormone therapy, such as leuprolide acetate or goserelin acetate,     may lessen the amount of androgens made by the body. Giving pazopanib after leuprolide or     goserelin may be an effective treatment for prostate cancer   "
199149|NCT00441727|"     The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily     versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous     low-dose acetylsalicylic acid.   "
199150|NCT00441740|"     The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination     versus the gemcitabine/docetaxel combination as first line treatment, offers a survival     advantage in patients with locally advanced/metastatic NSCLC.   "
199151|NCT00441753|"     Survivors of a cardiac arrest frequently develop severe postanoxic encephalopathy.     Derangements in cerebral blood after return of spontaneous circulation play an important role     in the pathogenesis of postanoxic encephalopathy. In the present study we examine the effect     of mild therapeutic hypothermia on cerebral blood flow and carbondioxide reactivity in     patients after cardiac arrest.   "
199152|NCT00441766|"     This study will explore the safety and effectiveness of different doses of AGN 203818 in     relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A     enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment     duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or     placebo over 12 week treatment duration.   "
199153|NCT00441779|"     Blood transfusions are frequently necessary in situations in which there is a large amount of     blood loss. In some individuals who receive a blood transfusion, white blood cells from the     donor's blood may remain in the body for years, a condition known as microchimerism. This     study will evaluate the occurrence of microchimerism among the following three groups of     individuals who previously received transfusions: 1) individuals with traumatic injuries; 2)     individuals with burn injuries; and 3) individuals who underwent elective orthopedic     operations.   "
199154|NCT00441792|"     The primary aim is to determine the difference in hospital length of stay between septic     patients given etomidate and those given midazolam for induction during rapid sequence     intubation (RSI) in the emergency department. To achieve this aim we plan to perform a     prospective randomized trial measuring the length of stay of patients meeting sepsis criteria     and requiring intubation. The investigators will compare in-hospital mortality rates between     patients given etomidate and patients given midazolam for induction. In addition to hospital     length of stay, secondary endpoints between the two groups will include length of stay in the     intensive care unit, death within 48 hours of admission, and total number of days intubated.      Research Hypothesis:      In adult patients presenting to the emergency department with sepsis and requiring rapid     sequence intubation, the length of stay of patients given etomidate will be greater than that     of patients given the alternative agent midazolam for induction.   "
199155|NCT00441805|"     Radiofrequency emmitting device, normaly used for thermage treatments will be used on 22 mild     to moderate acne patients faces.      The aim of the study is to check whether RF heating of subcutaneous and dermis will improve     acne in needed patients.   "
199156|NCT00441818|"     The purpose of this study is to determine the safety and effectiveness of TNX-650 for     Injection when administered to patients with refractory Hodgkin's lymphoma.   "
199157|NCT00447187|"     This was a pivotal trial to determine whether LX201 reduces the likelihood of a graft     rejection episode following corneal transplantation in patients at high immunological risk     for rejection.   "
199158|NCT00447200|"     We would like to investigate the natural variation in the strokevolume of the heart. At the     same time we would like to find out the minimal number of heart cycles necessary to discover     a 10% increase in strokevolume, after a fluid bolus of 200ml Voluven, when using Esophageal     Doppler.   "
199159|NCT00447213|"     The purpose of the study is to compare the human insulin inhalation powder plus insulin     glargine with injected insulin (regular human insulin or insulin lispro) plus insulin     glargine on lowering the blood sugar level.   "
199160|NCT00447226|"     This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive     ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.   "
199171|NCT00447369|"     The purpose of this study is to evaluate the efficacy and safety of pregabalin in comparison     with sodium valproate in migraine prevention with a randomized blinded crossover study.   "
199172|NCT00447382|"     The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and     South Africa. The aim of this trial was to make a safety comparison of insulin detemir     produced by a new production method (NN729) with insulin detemir made by the previous     production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks     at the same total daily dose and frequency of administration as their own pre-trial basal     insulin . During the trial doses were individualised based on subject's plasma glucose     measurements.   "
199161|NCT00447239|"     Aim. To determine whether the maintenance of normoglycemia decreases the incidence of     ventilator associated pneumonia (VAP), reduces its treatment period and the length of stay in     the intensive care unit.      Methods. Prospective, randomized, controlled trial. We enrolled 117 mechanically ventilated     trauma (71) and abdominal (46) surgical patients, older than 18, of both sex. In 57 patients     (strict glucose control group) we aimed to maintain the blood glucose level between 4.4 and     6. 1 mmol/L, while in 60 patients (standard glucose control group) it was maintained between     7.8 and 10.0 mmol/L, with the use of continues insulin infusion. Insulin dose adjustments     were based on measurements of glucose in capillary blood sample.      Key words: surgical patients; mechanical ventilation; pneumonia; blood glucose; insulin     infusion; hospital stay   "
199162|NCT00447252|"     The present study will focus on several objectives in the framework of the family perspective     and systemic understanding of the mourning process:        1. Identification of the psychological, social and practical needs of families that have          lost a child to terrorism.        2. Deepening and extending the knowledge of how families cope with the loss of a child in a          violent incident of a security-related nature.        3. Identification of risk and resilience factors within the family structure, and the          nature of the relationships within the family.   "
199163|NCT00447265|"     Systemic lupus erythematosus (SLE) is a chronic, multisystem, autoimmune disease in which the     body's immune system attacks its own normal tissues. This abnormal autoimmune response can     result in damage to many parts of the body, including the skin, joints, lungs, heart, brain,     intestines, and kidneys. Kidney problems occur in 60-75 % of lupus patients. The development     of lupus-related kidney disease (called lupus nephritis) is associated with an overall worse     prognosis.      SLE is usually treated with drugs that try to block inflammation caused by the immune system.     These treatments can create their own problems and they do not cure lupus. The drugs that are     often used to treat lupus nephritis include prednisone (steroids), cyclophosphamide     (Cytoxan), azathioprine (AZA or Imuran), and mycophenolate mofetil (MMF or Cellcept). The     main purpose of this study is to evaluate the safety and tolerability of etanercept compared     to placebo in combination with standard of care to treat individuals with active lupus     nephritis.   "
199164|NCT00447278|"     The purpose of this study is to demonstrate that atomoxetine is superior to other early     standard therapy (any treatment that investigator considers is appropriate to initiate for     the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term     functioning in approximately 400 children and adolescents with ADHD. Patients will be     pharmacological naïve prior to entry into the study.   "
199165|NCT00447291|"     Children with an excess in body weight, increase the risk of obesity-related co-morbidities     and cardiovascular diseases. Childhood obesity may be due to diets laden with fat and lack of     physical activity. Omega-3 fish oil is a supplementation that may promote a greater reduction     of pro-inflammatory mediators; combined with exercise and nutritional regimens it may also     help improve glycemic, lipid markers, and body composition in overweight children and     adolescents.   "
199166|NCT00447304|"     Acute cholecystitis is frequent in the elderly, or in patients with gall stones. Most cases     of severe or recurrent cholecystitis need surgery as final therapy. Today, the performed     procedure in most cases for cholecystectomy in the western world is laparoscopic     cholecystectomy. Only in some cases an open surgery has to be performed. Unclear is, what     time point is best, concerning outcome and morbidity of the patient, immediate surgery or     initial conservative therapy using antibiotics and symptomatic therapy with cholecystectomy     later on. Today the performed procedure is mainly chosen by the fact, what doctor sees the     patient first, surgeon or gastroenterologist. This study is performed to evaluate if one     therapy is superior.   "
199167|NCT00447317|"     This randomized study will pilot test an intervention, based on self-efficacy theory and     involving personal digital assistant (PDA)-based dietary self-monitoring, to improve     adherence to the peritoneal dialysis dietary regimen. 60 individuals, 21 years of age or     older, who are on continuous ambulatory peritoneal dialysis or nightly cycler peritoneal     dialysis, will be recruited to the study. Participants will be randomized to one of 2 groups.     Group A will receive a 4-month active intervention of decreasing intensity over time     delivered via mail, telephone, and during regularly scheduled dialysis clinic visits. Group B     will receive a 4-month attention control experience in which they receive reinforcement of     standard dietary education. With this study the investigators will:        1. Explore the impact of the intervention on dietary sodium intake,        2. Explore the intervention on blood pressure,        3. Explore the impact of the intervention on morning post dialysis weight (i.e. weight          after conclusion of continuous cycling peritoneal dialysis (CCPD) or after long dwell          for continuous ambulatory peritoneal dialysis (CAPD) patients, AND        4. Explore the feasibility and acceptability of the intervention   "
199168|NCT00447330|"     The purpose of this study is to evaluate the progression free survival of capecitabine     (Xeloda), oxaliplatin and bevacizumab (Avastin) in previously untreated metastatic     esophagogastric adenocarcinomas.   "
199169|NCT00447343|"     Decompressive surgery to relieve symptoms of spinal cord compression due to dysfunction, such     as arthritis, has proved variable in success. Past research has reported that approximately     one-third of surgery patients improved, one-third remained the same and one-third worsened.     Currently, there are no reliable tests that can predict the outcome following surgery. We are     hoping that this study will change that.      Using functional MRI (fMRI), we wish to investigate the relationship between clinical     symptoms and the recovery of brain activation following surgery. One can also track the     concentrations of different chemicals (metabolites) by using magnetic resonance spectroscopy     (MRS). We hypothesize that the recovery of normal brain activation patterns will coincide     with clinical improvement. Our objective in this study is to explore the potential role of     fMRI as a tool to prognose patients with cervical myelopathy.      Twenty-five patients with cervical myelopathy will be imaged using a high-powered (3 Tesla)     fMRI scanner before and six months following surgery. In addition, ten healthy controls will     be imaged to provide a baseline measure. Both the patient and control groups will complete     questionnaires at the time of their scans. These will provide information concerning the     subjective experience of the individuals throughout recovery. We will compare brain     activation patterns of control and patient groups to investigate how the brain heals     following decompressive surgery.   "
199173|NCT00447395|"     In recurrent miscarriage, the male factor has been poorly evaluated. In fact, in the vast     majority of clinical protocols of recurrent miscarriage, the sperm is not considered or     assessed. Recently, some studies have suggested the presence of genetic and metabolic sperm     anomalies in couples suffering from repeated miscarriages. Specifically, DNA fragmentation     and altered oxidative stress in the sperm and Y microdeletions from blood samples have been     related to an increased risk of miscarriage.The aim of the present study is to compare these     three parameters in: couples with recurrent miscarriage; oligozoospermic men with or without     recurrent miscarriages; and healthy sperm donors, in order to determine their actual impact     on this reproductive problem.   "
199174|NCT00447408|"     With this study the investigators will test, in a randomised clinical trial (RCT), the     efficacy of a behavioral dietary adherence enhancement intervention paired with PDA-based     dietary self-monitoring for controlling sodium intake. Seventy hemodialysis patients will be     recruited from units in Pittsburgh, Pennsylvania. Participants will be randomized to a     4-month PDA-based dietary counseling intervention or to a 4-month attention control.     Potential participants will be stratified by whether or not they have diabetes. Data on     primary and secondary outcomes will be obtained at baseline and four months. Primary     dependent variables are:        1. adherence to dietary sodium targets as assessed from 3-day food recalls,        2. average monthly interdialytic weight gain, and        3. average pulse pressure. Secondary dependent variables are:        4. adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats,          potassium, and phosphorus, as assessed from 3-day food recalls, (5) serum potassium and          phosphorus levels determined on a monthly basis, and (6) nutritional status as          determined from serum albumin. Laboratory data, interdialytic weight gain, and blood          pressure data will be obtained per dialysis center routine and abstracted from the          medical record. Three-day food recalls will be obtained at baseline, 4 and 8 months and          analyzed using the Nutrient Data System.   "
199175|NCT00447421|"     The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and     radiotherapy in the treatment of patients with Small Cell Lung Cancer.   "
199176|NCT00447434|"     Nattokinase is a potent fibrinolytic enzyme extracted from Natto. The objective of this study     was to compare the efficacy of the natto extract taken by healthy volunteers, dialysis     patients, and patients with cardiovascularrisk factors on the fibrinolytic factors and blood     lipids. The study has two primary objectives: to evaluate the effect of oral intake of     nattokinase in normal subjects, patients under dialysis, and patients of cardiovascular high     risk group, and to compare the effect of oral intake of nattokinase among three groups.      Fifteen subjects, 20-70 years, for each group will be enrolled to take the capsules of natto     extract orally for 2 months. Fibrinolytic factors, vital signs and blood lipids for efficacy,     and body weight, renal function and self-administered questionnaire for safety will be     assessed at screening, 3, 7, 28, and 56 days after the initiation of intake, and 2 weeks     after the cease of intake.   "
199177|NCT00447460|"     Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the     treatment of patients who have developed a GVHD refractory to the usual therapeutic measures     after undergoing an allogenic hematopoietic stem cell transplant.   "
199178|NCT00447473|"     This trial represents an attempt to offer second line immunotherapy plus chemotherapy to     patients who have failed prior taxane base therapy.   "
199179|NCT00447486|"     The purpose of this study is to determine whether GW842166 is effective in the treatment of     osteoarthritis pain of the knee.   "
199180|NCT00447499|"     The purpose of this study is to determine whether subjects with acromegaly (or their     partners) are able to self administer Somatuline Autogel at home.   "
199181|NCT00447512|"     Ghrelin, an acylated peptide consisting of 28 amino acids, is the endogenous ligand of the     growth hormone secretagogue receptor (GHS-R). It is synthesized predominantly in the stomach     but has been also identified in a variety of other organs. Alike, a wide range of central and     peripheral endocrine and non-endocrine actions has been described, e. g. being a releasing     factor of growth hormone, prolactin and ACTH, a modulator of cell proliferation and     apoptosis, a regulator of sleep-wake regulation, and a orexigenic hormone. Aims of this study     are:      A) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the     hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the     hypothalamic-pituitary-gonadal axis in healthy subjects of both genders (age groups: 20-30,     35-45, 60-70 years).      B) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the     HPA axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in patients with     major depression (age range: 20-65 years).   "
199182|NCT00447525|"     Primary objective:      To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second     booster to healthy 6 year-old children .      Secondary objectives:        -  Additional immunogenicity assessments.        -  To describe the safety profile of a single dose of REVAXIS® or DT-Polio®   "
199183|NCT00447538|"     The project utilize experience and knowledge gained from previous early childhood projects in     NYC post 9/11 and Sderot. The overall goals are:        1. Identifying young children (under 6 years old) and their parents who are suffering from          posttraumatic distress in the aftermath of the continuing conflict on Gaza border,          Israel.        2. Increasing the capacity of local institutions to treat toddlers and families at risk.        3. Providing resilience -building services that strengthen the coping abilities of families          and caregivers in response to continual terrorism.   "
199184|NCT00447551|"     Primary objective To evaluate the degree of correction achievable with Sculptra for     nasolabial folds, mid- and lower facial volume loss, jawline laxity and other signs of facial     ageing.      To document the types and incidence of device-related adverse events with Sculptra.   "
199185|NCT00454584|"     The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in     patients with moderate to severe plaque psoriasis.   "
199186|NCT00454597|"     To determine if the omentectomy diminishes hyperglycemia and improves the resistance to the     insulin in patients with morbid obesity and propensity to develop to Diabetes Mellitus type     2.   "
199290|NCT00456157|"     The purpose of this research study is to investigate the safety and tolerability of OP-1 when     it is injected into the knee joint of patients who have osteoarthritis on the knee.   "
199187|NCT00454610|"     The purpose of the study was to design a weight management program for Mexican American youth     and to determine the effectiveness of the program for weight management compared to a self     help program.        1. At the end of 6 months, individuals randomly assigned to Intensive Intervention (II)          (instructor/trainer led intervention) will lose more weight than individuals assigned to          Self Help (SH) only.        2. At the end of 1 year, individuals randomly assigned to II will maintain their weight          losses better than individuals assigned to SH.      Secondary hypotheses will include examination of main effects and interactions at the end of     6 months with the following secondary dependent measures: treatment adherence (e.g.,     attendance, food diaries, exercise diaries), blood levels, changes in percent body fat,     overall psychological functioning (PEDS-QL 4.0), and eating behaviors as assessed by food     frequency checklists.   "
199188|NCT00454623|"     The purpose of the study is to establish the normal levels of the hormone adiponectin in     women. Adiponectin is a newly discovered hormone, which is said to be associated with many     changes in the human body and metabolism. The researchers aim is to establish the normal     levels of this hormone. Hence, the researchers can identify people with abnormal levels who     may be at risk of diseases and can do more studies to help them.   "
199189|NCT00454636|"     This study will assess the safety and efficacy of Xeloda, given in combination with standard     chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric     cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy     regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the     chemotherapy regimen used. The anticipated time on study treatment is until disease     progression, and the target sample size is 100-500 individuals.   "
199190|NCT00454649|"     To determine the best dose of this investigational agent AG-013736 in combination with     various standard of care treatments for advanced solid tumors.   "
199191|NCT00454662|"     The purpose of this study is to investigate which combination therapy is more effective in     reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive     patients: AT1 subtype angiotensin II receptor antagonist/calcium channel blocker or AT1     subtype angiotensin II receptor antagonist/low dose diuretic.   "
199192|NCT00454675|"     To determine whether an average population of males and females who smoke 10 pack years or     more of cigarettes in a primary care setting with chronic bronchitis has already developed     significant changes on pulmonary function testing.   "
199193|NCT00454688|"     The purpose of this study is to evaluate the safety and efficacy of different doses of     asimadoline in the treatment of patients with irritable bowel syndrome.   "
199194|NCT00454701|"     Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months     to gather general health information.   "
199195|NCT00454714|"     This will be a prospective, phase IIIb, double-blind and randomized trial testing the effect     of single dose sildenafil application in patients with coronary vasospasm compared to placebo     application.      The target variable to be tested is the degree of coronary vasoconstriction in response to     intracoronary ACh application (in addition to clinical chest pain) which will be imaged by     coronary angiography and measured using quantitative coronary angiography software.      Main objective: Has sildenafil the potency to inhibit the induction of coronary vasospasm by     intracoronary ACh-application in patients with proven coronary artery spasm?      Secondary objective: Which degree of coronary vasospasm inhibition can be achieved with     sildenafil?   "
199196|NCT00454740|"     To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have     OAB syndrome (urgency, with or without urge incontinence, usually with frequency and     nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin     succinate due to lack of sufficient improvement in urgency episodes   "
199197|NCT00454753|"     This protocol allows CML and Ph+ ALL subjects who are resistant to or intolerant of imatinib     mesylate, to potentially benefit from dasatinib. It is intended to provide patients with     access to dasatinib while awaiting reimbursement decision in Korea and it will also provide     additional data on the safety of dasatinib in Korean population   "
199198|NCT00454766|"     Primary Objective:      To pilot test high and low literacy patient education materials for colposcopy clinic     patients, assessing impact on patient knowledge and patient feedback about the materials.   "
199199|NCT00454779|"     This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation     clinical trial of docetaxel and cisplatin combination chemotherapy with and without     panitumumab in the first-line treatment of subjects with metastatic or recurrent head and     neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail     the chemotherapy only arm. This study will be conducted in the United States. Approximately     150 subjects with histologically or cytologically confirmed metastatic and/or recurrent     SCCHN.   "
199200|NCT00454792|"     The purpose of this study is to compare patients with low back pain (LBP) and Modic Changes     from The Backcenter Funen, Ringe:        1. To compare the effect of two types of non-operative treatments:           A. exercise and advice to be physically active           B. restitution and advice not to overload the spine        2. To investigate if the results of the treatment are influenced by gender, age, smoking,          and physical load.   "
199201|NCT00454805|"     The purpose of this study is to determine whether AZD2171 can effectively improve time to     tumour progression when added to fulvestrant in patients with advanced hormone sensitive     breast cancer who progressed on prior hormonal therapy.   "
199202|NCT00454818|"     The study is divided into 2 parts. In the first part, the safety of the gene transfer agent     MYDICAR® will be evaluated. In the second part, the ability of MYDICAR® to improve heart     function will be studied.   "
199203|NCT00454831|"     Chitosan is a natural product that is produced commercially through the deacetylation of     chitin, which is found in the exoskeleton of crustaceans. It has been suggested that chitosan     has a lipid-lowering effect.      This study was designed to determine if HEP-40 chitosan (Enzymatic Polychitosamine     Hydrolysate - 40kDa), a short-chained chitosan with a molecular weight of 40 kDa, is safe and     effective in lowering LDL-cholesterol levels in patients with mild to moderately elevated     cholesterol levels and who have not been previously treated with other lipid-lowering agents.   "
199204|NCT00454857|"     This is a multi-center prospective observational descriptive study complemented by a     retrospective chart review. Patients diagnosed with ITP and currently treated for ITP by a     hematologist or hematologist-oncologist will be recruited from community-based clinics and     academic/referral centers. They will be followed prospectively for a period of 12 months. At     inception, participants' charts will also be reviewed from the date of enrollment     retrospectively to the date of diagnosis or the previous 36 months, whichever is less.   "
199205|NCT00454870|"     The purpose of this study is to determine in an 8-week treatment study if MEM 3454 is a safe     and effective treatment for patients with mild to moderate Alzheimer's disease.   "
199206|NCT00454883|"     Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective     disorders.   "
199207|NCT00454896|"     The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in     patients with urgency who have overactive bladder syndrome.   "
199208|NCT00454909|"     The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK     Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults     11-25 years of age.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.      The protocol posting has been updated following a protocol amendment.   "
199209|NCT00454922|"     Glaucoma is a leading cause of blindness worldwide. Non-adherence to glaucoma medication,     which may result in loss of vision, is known to be prevalent. Available information regarding     adherence to prescribed medical therapy suggests that some apparent treatment failures may     actually be due to non-adherence. The investigators' specific aim is to conduct a study that     will examine the effect of a glaucoma educator intervention on adherence to topical glaucoma     therapy. The investigators' hypothesis is that patient education and counseling delivered by     a trained glaucoma educator, through both planned visits and telephone contacts, will     increase adherence to topical glaucoma therapy.   "
199210|NCT00454935|"     The purpose of this study is to investigate the correlation of SV2A expression in surgically     removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with     their clinical response to levetiracetam.   "
199211|NCT00455104|"     CFDI NATIONAL REGISTRY      Fabry disease is a rare, inherited, genetic condition due to a deficiency of an enzyme called     alpha-galactosidase A. This enzyme deficiency causes the small blood vessels to accumulate a     substance called glycolipid. Without sufficient levels of the enzyme, alpha-galactosidase A,     persons with Fabry Disease develop severe neuropathic pain, kidney disease, heart disease,     stroke and/or premature death; often before the age of 60.      Fabry Disease is estimated to affect approximately one out of every 40,000 males and up to     twice as many females in Canada. We do not have the exact number of persons in Canada who     have this disease. A common problem in studying rare conditions is the difficulty in     identifying the majority of people suffering from such a disease. Gathering their health     information in order to better understand the natural disease progression and its response to     treatment is difficult.      Early ERT studies involving humans had small numbers of subjects and the studies were of     short duration. The results of these clinical studies did lead to approval of the therapy in     many countries around the world including Canada. To date though, evidence of the usefulness     of ERT and its direct impact on the natural course of Fabry disease has been limited, while     its cost continues to be very high. As a result of these issues, there will need to be     continued and long-term collection of information related to the effectiveness of ERT and     other treatments to better document its true clinical outcomes in Canadian people with Fabry     disease.      The Canadian Fabry Disease Initiative National Registry (CFDI-NR) is an observational,     voluntary registry designed to collect outcomes data on Fabry disease from people living in     Canada.   "
199212|NCT00455117|"     Aim of this trial:      To investigate whether post-craniotomy analgesia with (i) intravenous (IV) parecoxib plus     intravenous paracetamol is superior to (ii) intravenous paracetamol alone.      Study Hypothesis:      Post-operative analgesia with intravenous parecoxib in combination with intravenous     paracetamol will be superior to intravenous paracetamol alone.   "
199213|NCT00455130|"     Cystic fibrosis is the most frequent lethal genetic disease of childhood. Causes disruption     of glandular function of the pancreas, intestine, liver, lungs (causing chronic lung     infection with emphysema), sweat glands and reproductive organs. We know that many CF     patients die of lung failure, brought about in part by repeated lung infections caused by     thick, sticky mucus that cannot be readily cleared from the lung.      Inhaled mannitol is an osmotic agent that has been investigated in a number of small studies     that have examined mucociliary clearance, quality of life and lung function in CF and     bronchiectasis. The promising results of these studies warrant futher investigation. The aim     of this study is to assess the safety and efficacy of inhaled mannitol when administered     twice a day over two weeks in CF.   "
199214|NCT00455143|"     This is a pilot study to evaluate the effect of dexmedetomidine in the prevention of delirium     in non-cardiac surgical patients. The preliminary data regarding the effect of     dexmedetomidine on delirium comes from a study underway at Stanford. We propose to randomize     fifty patients into two different protocols, one using dexmedetomidine until PACU discharge     (hip replacement) and the other using dexmedetomidine for 24 hours in a monitored setting.   "
199215|NCT00455156|"     The purpose of this study is to evaluate the one-year data on the contraceptive efficacy and     safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new     delivery system for contraception.   "
199244|NCT00455546|"     The study will be conducted at up to 80 centers worldwide and will be a double-blind     randomized parallel group placebo controlled study among subjects with stable coronary artery     disease (CAD). Subjects will be randomized to receive either placebo tablets or one of 4     orally active doses of A-002. The duration of study drug therapy will be 8 weeks.   "
199245|NCT00455559|"     This is a Phase II trial designed to determine the efficacy and safety of perifosine plus     imatinib mesylate in patients with advanced GIST who develop progressive disease or     recurrence while receiving imatinib mesylate.   "
199323|NCT00456586|"     12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate     the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with     OFF phenomena advanced PD who were treated with levodopa/carbidopa.   "
199216|NCT00455169|"     Background. Influenza is increasingly recognized as causing severe respiratory illness in     children. High-risk infants, like former premature infants, and particularly those with lung     disease, have influenza hospitalization rates about five times higher than healthy children.     Influenza vaccine does not protect young children against influenza as well as it does     healthy adults. A small study that measured antibodies (proteins that protect against     infection) to influenza suggested that premature infants get even less protection from     influenza vaccine than full-term infants. More information about influenza vaccine in     premature infants is needed. The overall goals of this project are to collect information     about the how well the influenza vaccine induces antibody production, and to develop the     collaborative network of centers necessary for a larger trial of influenza vaccine in     premature infants.      Objective and Hypotheses. The objective of this study is to measure the amount of protective     antibody produced by influenza vaccine in premature (less than 30 weeks' [about 7 months]     gestation at birth), extremely-low-birth-weight (1000 grams [2¼ pounds] or less at birth)     infants. Influenza vaccine needs to be given yearly. We will assess premature infants during     their first series of influenza vaccines. We hypothesize that the levels of antibody will be     lower in premature infants receiving their first series of influenza vaccine than in     full-term infants.      Design. We will measure the immune response in premature and full term infants. During the     2007-2008 influenza season, a total of 92 subjects, divided among 2 groups (premature infants     6-17 months old receiving their first influenza vaccine series and full-term infants 6-17     months old receiving their first influenza vaccine series) will be recruited at a consortium     of five centers (the University of Rochester, the University of Texas Southwestern Medical     Center, Wake Forest University, the University of Miami and the State University of New York     at Buffalo), receive 2 doses of influenza vaccine, and have antibody and immune cell     responses to each vaccine component measured 4-6 weeks after the second dose of vaccine.      Potential Impact. If this study and future investigations suggested ways to improve premature     infants influenza vaccine responses, they could lead to changes in recommendations for the     number or timing of vaccine doses or of the type of vaccine used in this high-risk group.   "
199217|NCT00455182|"     The purpose of this study is to determine whether patients treated with acupuncture     post-operatively following knee or hip arthroplasty achieve better pain control as measured     by the Visual Analog Scale and pain medication use.   "
199218|NCT00455195|"     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the     body's cells to break down glycogen (a stored form of sugar) within specialized structures     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates     and is stored in various tissues, especially heart and skeletal muscle, which prevents their     normal function. The objective of this extension study is to assess the long-term safety and     efficacy of alglucosidase alfa treatment in patients with Late-Onset Pompe Disease who were     previously treated under the placebo-controlled, double-blind study AGLU02704 (NCT00158600).   "
199219|NCT00455208|"     The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating     rheumatoid arthritis and osteoarthritis.   "
199220|NCT00455221|"     The primary purpose of this study is to evaluate the safety of a peptide-gene vaccine against     CML in patients under Imatinib treatment.      We will also perform some laboratory tests suggesting biological response.   "
199221|NCT00455234|"     Three hundred consecutive adult patients presenting to the emergency services of the     department of psychiatry and who are diagnosed by the treating doctor to be needing     tranquillization to control agitated or aggressive behavior will be randomized to receive     either Injection Olanzepine I.M. or Injection Haloperidol 10mg + Injection Promethazine 50 mg     in this parallel group, block randomized, centrally-randomzed, allocation-concealed,     assessor-blinded pragmatic clinical trial.      The main outcome measure that the two treatments would be compared on would be the clinical     state of the patient 4 hours after intervention, but the rate of tranquillization, degree of     sedation, proportions tranquil and / or asleep at 15, 30, 60 and 240 minutes, need for     additional medication, use of physical restraints, doctors called back, numbers absconding     and adverse effects at each of these time points would also be compared. Compliance with oral     medication and adverse effects at the end of 2 weeks would also be compared.   "
199222|NCT00455247|"     Anti-cancer treatment is often inducing side-effects that can affect the compliance to the     treatment protocol and quality of life of the patients. The researchers will study if the     nutritional intervention with the product could abrogate the undesired effects in a     preventive manner.   "
199223|NCT00455260|"     This study aims to examine the safety, tolerability and pharmacokinetics of transdermal     delivery of human Growth Hormone (hGH or somatropin) using the ViaDerm device in adult     patients with Growth Hormone Deficiency Syndrome.   "
199224|NCT00455273|"     The project outline which follows is a pilot investigation aimed at improving MRI parameters     in DCE-MRI to optimize the detection of treatment responses in LABC.      The primary objective is to define the activity of neoadjuvant chemotherapy in patients with     biopsy proven operable breast cancer. Secondary objectives include evaluating a new MRI pulse     sequence to optimize DCE-MRI of LABC responses.   "
199225|NCT00455286|"     In this study we will test the hypothesis that concurrent chemoradiation (CCRT) with     temozolomide after induction chemotherapy by conventional high-dose methotrexate (HD-MTX)     plus dexamethasone may be an effective and well tolerated treatment for immunocompetent     patients with PCSNL. Corticosteroid can effectively reduce brain edema and corticosteroid     alone has resulted in complete or partial remission in about 40% patients with PCNSL. To     enhance local disease control, CCRT with temozolomide will be used in the study. Temozolomide     is a well-tolerated oral alkylating agent that is able to permeate the BBB. Concurrent     temozolomide with WBRT has shown superior effect to WBRT alone for the treatment of     metastatic brain tumors and glioblastoma multiforme. In addition, temozolomide has     single-agent activity for PCNSL (21% CR in relapsed or refractory PCNSL in a phase II trial).      This is an open-label, non-randomized, multi-center phase II study. The primary end point of     is the complete response rate. This study is a two-stage design for testing non-inferiority     of the proposed treatment as compared to the approximately 80% response rate reported for     conventional treatment. Assuming a non-inferiority margin of 20%, a sample size of 25     subjects, which provides an 80% power for establishment of non-inferiority. At the first     stage, 15 subjects are to be enrolled. If equal to or more than 6 patients achieve complete     response, the study would accrue additional 10 subjects. The treatment regimen is as follows.      Induction chemotherapy: MS regimen (repeated every 14 days, total 4 cycles)        -  Methotrexate 3.5 g/m2 i.v. infusion 4 hours on day1        -  Methylprednisolone 200 mg/m2/day i.v. infusion 30 minutes, on day1-4 Concurrent          chemoradiotherapy (CCRT)        -  Whole brain radiation therapy (WBRT) 2 Gy per fraction daily, 5 days per week          Temozolomide 75 mg/m2/day orally daily, only on the days of WBRT   "
199226|NCT00455299|"     The study aims to prove differences or equalities in outcome for patients operated with     laparoscopic ventral hernia repair with different methods of fixation of mesh and with or     without approximation of defect prior to meshfixation.   "
199246|NCT00455572|"     The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer     patients are able to give an immune response to injections of the immunotherapeutic product     GSK1572932A, and to find out more about the safety of this treatment. A course of eight     injections will be administered over 21 weeks; including screening for suitability and all     tests, the duration of the study for a patient will be 30-35 weeks. During this period     various tests will be performed, including physical examinations and blood tests. The     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
199227|NCT00455312|"     Transplantation with stem cells is a standard therapy in many centers around the world.     Previous experience with stem cell transplantation therapy for leukemias, lymphomas, other     cancers, aplastic anemia and other non-malignant diseases, has led to prolonged disease-free     survival or cure for some patients. However, the high doses of pre-transplant radiation and     chemotherapy drugs used, and the type of drugs used, often cause many side effects that are     intolerable for some patients. Slow recovery of blood counts is a frequent complication of     high dose pre-transplant regimens, resulting in a longer period of risk for bleeding and     infection plus a longer time in the hospital.      Recent studies have shown that using lower doses of radiation and chemotherapy (ones that do     not completely kill all of the patient's bone marrow cells) before blood or bone marrow     transplant, may be a better treatment for high risk patients, such as those with Dyskeratosis     Congenita (DC) or Severe Aplastic Anemia(SAA). These low dose transplants may result in     shorter periods of low blood counts, and blood counts that do not go as low as with     traditional pre-transplant radiation and chemotherapy. Furthermore, in patients with     Dyskeratosis Congenita or SAA, the stem cell transplant will replace the blood forming cells     with healthy cells.      It has recently been shown that healthy marrow can take and grow after transplantation which     uses doses of chemotherapy and radiation that are much lower than that given to patients with     leukemia. While high doses of chemotherapy and radiation may be necessary to get rid of     leukemia, this may not be important to patients with Dyskeratosis Congenita or SAA. The     purpose of this research is to see if this lower dose chemotherapy and radiation regimen     followed by transplant is a safe and effective treatment for patients with Dyskeratosis     Congenita or SAA.   "
199228|NCT00455325|"     Metabolic syndrome consists of a group of co-occuring conditions that increase an     individual's risk of developing heart disease, stroke, and diabetes. The purpose of this     study is to evaluate the short-term effectiveness of chloroquine, a protein-activation     medication, at improving metabolic syndrome.   "
199229|NCT00455338|"     The primary objective is to determine if meals of different fat and fiber content affect     postprandial plasma testosterone concentration in women with polycystic ovary syndrome. Our     hypothesis is that a high-fiber meal will have a greater reduction in testosterone     composition compared with a high-fat meal.   "
199230|NCT00455351|"     Phase I study. Side-effects when combined with standard palliative radiotherapy.   "
199231|NCT00455364|"     The purpose of this study is to compare the safety and efficacy of Voriconazole with     Itraconazole following lung transplantation.   "
199232|NCT00455377|"     The aim of the study is to examine inflammation in the airways and in peripheral blood, in     workers in a cement plant i Norway.   "
199233|NCT00455390|"     Argumentation The frequency of post-traumatic syndrome disorder (PTSD) is estimated around 1%     of the entire European population. In some specific populations, this percentage increases     (soldiers – 15 to 22%, war or persecuted refugees – 80%, post office or bank employees     submitted to an hold-up – 17%, firemen – 10 to 30%, emergency care employees – 11%, people     who underwent a terrorist attack or any violence – 20 to 65%...)      Prevention is yet poor, secondary prevention trying to avoid a post traumatic disorder     apparition early after the traumatic event. There is currently two types of secondary     prevention :        -  Mitchell’s debriefing based upon stress and its theories, using cognitive and          behavioural approaches        -  French debriefing (post-immediate psychotherapeutic intervention) based on the          traumatism, never realised before second day post event and applied by mental health          professionals.      The current controversy of the Mitchell’s debriefing leads us to evaluate the post-immediate     psychotherapeutic intervention, never evaluated yet.      Scientific Objectives Primary objective: To verify that post-immediate psychotherapeutic     interventions (proposed after 2 days and before the end of first month post event) decrease     incidence, duration and intensity of psychotraumatic disorders at one year, versus a control     group.      Secondary objectives :        -  To document the efficacy of these interventions regarding professional, social and          familial adaptation.        -  To identify predictive factors of response to this strategy.      Method Experimental Design National multicentered, randomized, single blind study Study     Population 330 men or women aged 18 to 65, subjected to a potentially traumatic event     (criteria A1, DSM IV) and having presented an emotional reaction (intense fear, impotency or     horror, criteria A2, DSM IV). This event must have happened within 8 days prior     randomization. Patients treated with βblockers and patients suffering from psychopathologic     disorders won’t be considered for the study.      Outcome measures Primary outcome: PTSD frequency (on the basis of questionnaire CAPS).      Secondary outcome:        -  Complete and subsyndormic PTSD occurence (CAPS),        -  Intensity of psychotraumatic disorders (Sheehan scale),        -  Psychopathologic disorder frequency (CIDI SF),        -  Evolution of anxiety/depression (HAD scale),        -  Alcoholization frequency (CAGE scale),        -  Frequency of somatic adverse events,        -  Access to health care (number and types of contacts).      Expected benefits The post-immediate psychotherapeutic intervention shall avoid psychological     disorders apparition or improve its symptoms. This would decrease consequences on personal     life (social, relational and professional).      The study results will allow a better knowledge of these post traumatic disorders.   "
199234|NCT00455403|"     Metabolic syndrome consists of a group of co-occuring conditions that increase an     individual's risk of developing heart disease, stroke, and diabetes. The purpose of this     study is to evaluate the long-term effectiveness of chloroquine, a protein-activation     medication, at reducing the progression of atherosclerosis in patients with the metabolic     syndrome.      Sub-study: Vascular endothelial growth factor(VEGF)and Cardiometabolic Risk, The purpose is     to determine if the association of VEGF with atherosclerosis indicates that it should be a     marker of the disorder.   "
199235|NCT00455416|"     A dietary intervention study in patients with Follicular Lymphoma (FL) Stage III/IV to assess     the ability of several dietary factors to induce apoptosis, inhibit cell proliferation and     modulate tumor cell infiltrate in vivo.   "
199236|NCT00455429|"     The purpose of this study is to evaluate the safety and effectiveness of four dose regimens     (pattern of giving treatment) of JNJ-26113100 in the treatment of adult Atopic Dermatitis     ([AD]; skin rash, inflammation) that is moderate in severity.   "
199237|NCT00455442|"     This is a two-week study testing the efficacy and safety of mifepristone in the prevention of     olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight     and BMI.   "
199238|NCT00455455|"     The primary objective of this study is to compare subjective symptoms and ocular health in a     group of individuals who are currently wearing soft contact lenses on a daily wear basis,     after a short period of no lens wear and during the time course when using differing care     regimens.   "
199239|NCT00455468|"     Pneumonia is the leading cause of childhood morbidity and death in many developing countries     including Bangladesh, causing about 2 million deaths worldwide each year. Pneumonia is an     infection of the lungs, most commonly caused by viruses or bacteria like Streptococcus     pneumoniae and Haemophilus influenzae. Depending on the clinical presentation, pneumonia can     be classified as very severe, severe or non-severe, with specific treatment for each of them     except for antibiotic therapy. Severe and very severe pneumonia require hospitalization for     additional supportive treatment such as suction, oxygen therapy and administration of     bronchodilator. In Bangladesh, the number of hospital beds is inadequate for admission of all     pneumonia cases that require hospitalization; however, it is also important to provide     institutional care to those children who cannot be hospitalized due to bed constraints.     Provision of appropriate antibiotics and supportive cares during the period of stay at     established day-care centres could be an effective alternative. The impetus for this study     came from the findings of our recently completed study titled Daycare-based management of     severe pneumonia in under-5 children when hospitalization is not possible due to the lack of     beds. This study successfully managed children (n=251), but it was not a randomized trial     and thus direct comparison of the efficacy of management of severe pneumonia at the day-care     centre, essential for building confidence for implementing this management policy, is not     possible. We, the researchers at the International Centre for Diarrhoeal Disease Research,     Bangladesh, could not plan a randomized, controlled trial (RCT) because of ethical reasons.     Now that we have data suggesting effectiveness as well as safety of the day-care based     treatment for management of children with severe pneumonia, a RCT should be possible. Two     hundred fifty-one children with severe pneumonia were enrolled at the Radda Clinic from June     2003 to May 2005. The mean age was 7±7 (2-55) months, 86% infants, 63% boys and 91%     breast-fed. History of cough was present in 99% cases, fever in 89% and rapid breathing in     67% cases. Forty-four percent of children were febrile (≥38°C), 93% children had vesicular     breath sound and 99% bilateral rales. Fifty-seven percent of children were hypoxic with mean     oxygen saturation of (93±4)%, which was corrected by oxygen therapy (98±3)%. Eighty percent     of children had severe pneumonia and 20% had very severe pneumonia. The mean duration of     clinic stay was (7±2) days. Two hundred thirty-four (93%) children completed the study     successfully, 11 (4.4%) referred to hospitals (only one participant had to visit hospital at     night due to deterioration of his condition, 9 were referred to hospital at the time of     clinic closure i.e., at 5 pm and one participant was referred to hospital during the morning     hours) and 6 (2.4%) left against medical advice (LAMA). There was no death during the period     of clinic stay but only four (1.6%) deaths occurred during the 3 months follow-up. The study     indicated that treatment of severe pneumonia in children at the day-care centre is effective     and safe and thus it is comparable to the hospital care. If the day-care based management is     found to have comparable efficacy to that of hospitalized management of severe pneumonia in     children then they could be managed at outpatient, day-care set ups reducing hospitalization     and thus freeing beds for management of other children who need hospitalized care.     Additionally, availability of the treatment facility in community set-ups will be cost and     time saving for the population. Children of either sex, aged 2-59 months, attending the Radda     Clinic and Institute of Child Health and Shishu Hospital (ICHSH) with severe pneumonia will     be randomized to receive either the day-care management at the clinic or hospitalized     management at the ICHSH. Children randomized to receive day-care treatment will stay at the     clinic from 8 am-5 pm and will receive antibiotics and other supportive cares. At 5 pm, they     would be send to respective homes with advice to bring back their children to the clinic next     morning, and advised to provide other supports at home. The same management would be     continued till improvement and discharged and followed up every 2 weeks for 3 months.     Children randomized to receive hospitalized management would be admitted at ICHSH and receive     standard treatment like antibiotics and other supportive cares. The same treatment would be     continued for 24 hours/day (rather than 9 hours/day at the day-care clinic) till improvement     and discharged and followed-up at the ICHSH every 2 weeks for 3 months. About 3000 children     with pneumonia visit Radda Clinic each year and about 200 of them will have severe pneumonia     requiring hospitalization. Thus, we hope to enroll 368 (184 in each site) children with     severe pneumonia during a 2-year study period.   "
199240|NCT00455494|"     The purpose of this study is to test the safety of a 2100 mg dose of AQ-13, a new candidate     antimalarial active against drug-resistant P. falciparum infection, and to determine the     effect of a standard fatty meal on the absorption of the drug from the gut and its blood     levels.   "
199241|NCT00455507|"     The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of     istradefylline for reducing the mean total hours of awake time per day spent in the OFF state     in patients with advanced Parkinson's disease (PD) treated with levodopa.   "
199242|NCT00455520|"     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety     of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in patients with     moderate to severe pain from diabetic peripheral neuropathy.   "
199243|NCT00455533|"     The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus     cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin     plus cyclophosphamide in patients with early stage breast cancer. In addition the study will     verify predefined biomarkers as well as discover new biomarkers that could identify patients     who are more likely to respond to ixabepilone than standard paclitaxel based therapy.   "
199252|NCT00455650|"     We are conducting this study to find out if blocking or partially stimulating the effects of     nicotine in the brain can affect memory and concentration. Nicotine is the addictive drug     found in tobacco products. Our subjects will be people with and without mental illness     (schizophrenia), smokers and non-smokers.      We will use a medication called mecamylamine (Inversine) to block the effects of nicotine on     the brains of our subjects. We will also use a medication called varenicline (Chantix) to     partially increase the effects of nicotine on the brains of our subjects. This study also     uses a placebo, a pill that does not have any active ingredients but looks exactly like the     mecamylamine and varenicline pills. We will compare the effects of giving mecamylamine or     placebo to people who have schizophrenia and people who do not have schizophrenia.      We know that people with schizophrenia smoke heavily and find it harder to stop smoking than     most other people do. Studies have shown that people with schizophrenia may smoke more     because nicotine helps their concentration and memory. We are interested in helping people     with schizophrenia smoke less. Mecamylamine blocks the parts of the brain that react to     nicotine and varenicline partially stimulates and partially blocks the parts of the brain     that react to nicotine. Both medications may decrease the effects that smoking has on the     body.   "
199253|NCT00455663|"     This study will compare the effectiveness of three treatments in improving medication     adherence, symptoms, and function in people with schizophrenia.   "
199254|NCT00455676|"     Comparison between two techniques of osteotomy wich are more or less invasive : two criterias     : clinical data and x-rays data.      All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone     surgery CHU Limoges :        -  Scarf or Jonhson (chevron) osteotomy        -  Experienced surgeon : Pr ARNAUD, Pr MABIT or Pr CHARISSOUX.   "
199255|NCT00455689|"     The purpose of the study is to examine the impact of hot flushes on sleep, mood, and     well-being. Hot flushes (or hot flashes) are a feeling of being overheated, and often are     followed by heavy sweating, skin becoming red and hot, and discomfort. Sometimes hot flushes     are followed by chills. Some women experience a rapid heart rate. Hot flushes that happen at     night are called night sweats, and they may interfere with sleep.      The investigators will cause hot flushes by giving study participants a hormone medication     called leuprolide (Lupron). Hormones are chemicals that are naturally produced in the body.     Leuprolide is a manufactured (artificial) hormone that will make the body think that it has     reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after     taking leuprolide.      The investigators will also evaluate changes in sleep, mood, and feelings of well-being over     the course of the study. The investigators will use questionnaires to measure these changes.   "
199256|NCT00455702|"     The study aims to assess the effects of single dose and repeated weekly dosing of 50mg     d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients.     The study will also examine the effects of 50mg d-cycloserine on positive symptoms and     negative symptoms, as well as assess tolerability and side-effects.   "
199257|NCT00455715|"     The study is a double-blind, placebo-controlled, random-order, single-dose crossover trial of     sildenafil 50 & 100 mg added to stable antipsychotic treatment in schizophrenia patients to     assess whether this PDE5 inhibitor improves cognitive functioning (including verbal memory,     fluency, attention, spatial memory, motor speed, and executive function) and clinical     symptoms (psychotic, negative, mood symptoms, and self-reports of side-effects).   "
199258|NCT00455728|"     This study is a multicenter, open label, observational, post marketing surveillance study of     NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect     long-term safety and effectiveness information on NutropinAq® during treatment of paediatric     growth disorders.   "
199259|NCT00455741|"     The purpose of the study is to study the effects of aging, estrogen and progesterone on the     brain. Specifically, we want to look at how the hypothalamus and pituitary (two small glands     in the brain) respond to estrogen. The pituitary gland is controlled by the hypothalamus. The     hypothalamus secretes GnRH (Gonadotropin-Releasing Hormone) that signals the pituitary to     secrete the reproductive hormones, LH (Luteinizing Hormone) and FSH (Follicle Stimulating     Hormone). These hormones act on the ovaries and signal the ovaries to produce estrogen and     progesterone. Estrogen in the bloodstream then acts on the brain to stop this system when the     blood has sufficient estrogen levels. This is called estrogen feedback. This study will     determine which areas of the brain are affected by estrogen feedback by administering     estrogen and progesterone, both natural hormones.   "
199260|NCT00455754|"     The purpose of this study is to determine whether treatment with esomeprazole alone is able     to heal patients with lymphocytic gastritis   "
199261|NCT00455767|"     The study is aimed to assess safety of Depelestat treatment, as well as efficacy on     prevention and treatment of alveolar inflammation in early pulmonary fibrosis in patients     suffering from persistent Acute Respiratory Distress Syndrome.   "
199262|NCT00455780|"     After a three month weight loss phase involving the use of meal replacements, participants     are randomized into different weight loss maintenance conditions. Aim 1: To test the     hypothesis that the meal replacement (MR) and reduced energy density eating (REDE)     interventions, when added separately to the LEARN program, will produce superior weight loss     maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the     weight loss maintenance condition that combines MRs and REDE will produce better maintenance     of weight losses than either individual component and than the LEARN-only condition. Aim 3:     To test the hypothesis that the two conditions receiving the REDE intervention will     experience longer-lasting improvements in the energy density and nutritional composition of     the diet compared to the two non-REDE conditions.   "
199291|NCT00456170|"     The hypotheses of this study is that the use of the instrument “Harmonic Scalpel” (ultrasonic     shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the     use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced     blood loss, reduced operating time, reduced post-operative pain and earlier discharge from     hospital. Other outcome measure will include complications and cost.   "
199324|NCT00456599|"     This study will examine a sequence of treatments including pre-operative chemotherapy and     radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.   "
199263|NCT00455793|"     We will obtain data using multi-slice CT technology to detect subclinical coronary disease in     the HIV population. Determination of subclinical cardiovascular disease using noninvasive     technology and elucidation of the associated risk factors will help to guide targeted therapy     to prevent cardiovascular events in this patient population.      We will investigate the prevalence of coronary plaque lesions and coronary artery     calcifications in men and women with HIV disease as determined by 64-row multidetector     computed tomography (MDCT) and MDCT coronary angiography in comparison to age-matched control     subjects without HIV infection. We hypothesize that evidence of coronary artery calcification     and coronary plaque lesions as seen by MDCT will be present in individuals with HIV more than     non-HIV control subjects of the same age. We also hypothesize the degree of atherosclerosis     will be increased in HIV patients compared to control subjects.      We will evaluate the metabolic and inflammatory factors associated with coronary artery     disease in HIV-infected individuals. We hypothesize that traditional cardiac risk factors as     well as metabolic and inflammatory changes associated with HIV and its treatment such as     dyslipidemia, increased secretion of inflammatory markers, decreased adiponectin, increased     insulin resistance and increased visceral fat may be associated with coronary artery disease     in HIV-infected individuals.   "
199264|NCT00455806|"     Successful H. pylori eradication therapy remains a challenge in medical practice. Despite     promising data for first-line, second-line and rescue treatment options based on clinical     trials as well as guidelines and expert recommendations, success rates can often not be     reproduced in general practice. Rescue options for patients with failed initial or     second-line therapy are definitely needed. The new fluoroquinolone moxifloxacin may represent     an effective and save treatment option (in combination with a PPI and amoxicillin) for rescue     therapy of H- pylori positive patients.However, optimal duration of therapy (7-day course vs     14-day course) has to be determined   "
199265|NCT00455819|"     The aim of this study is to investigate the safety of treatment of pulmonary embolism in an     outpatient setting based on normal pro-BNP levels. The mortality rate and the incidence of     hemodynamic instability as well as major bleeding and recurrent venous thromboembolism (VTE)     in the outpatient group will be studied.   "
199266|NCT00455832|"     The aim of this study is to study the effect of peginterferon alpha and ribavirin on     spermatozoa.   "
199267|NCT00455845|"     this study is to determine whether the frequency and severity of pelvic pain or dysmenorrhea     are reduced in women with symptomatic endometriosis in whom a Lng IUD is inserted after     operative laparoscopy compare with those treated with laparoscopic surgery only   "
199268|NCT00455858|"     This trial is conducted in Asia. This trial aims for evaluating the glycaemic control,     measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to     oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.   "
199269|NCT00455871|"     The purpose of this study is to determine the benefits, if any, of combination therapy with     Lucentis plus reduced fluence photodynamic therapy with Visudyne.   "
199270|NCT00455884|"     This study is a multicenter, open-label, observational, post marketing surveillance program     to collect information on the use of NutropinAq® in adults suffering from Growth Hormone     Deficiency in Germany, Italy, and United Kingdom   "
199271|NCT00455897|"     The primary goal of this study is to determine the effects (good and bad) of     Granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with CHOP-R on     diffuse Large B cell Non-Hodgkin's lymphoma (DLBCL). The standard of care for DLBCL is the     combination of drugs known as CHOP-Rituximab (CHOP-R). The drugs that make up CHOP-R are the     chemotherapy drugs cyclophosphamide, doxorubicin and vincristine, prednisone and rituximab.     GM-CSF is a drug that stimulates the immune system by increasing the numbers of white blood     cells. Previous research has shown that GM-CSF might help rituximab to be more effective in     treating lymphoma.   "
199272|NCT00455910|"     The GFM previously conducted a dose-escalating phase II trial of thalidomide in MDS with a     minimum dose of 200mg/d and a maximum dose 800mg/d. Responses were evaluated according to IWG     criteria at week 16 and thalidomide continued up to week 56 in responders. 82% patients     received at least 8 weeks of treatment and were evaluable. 59% had hematological improvement,     mainly on the erythroid lineage (Increase of Hemoglobin). Most responses were observed at low     doses and between 4 and 8 weeks.      The objectives of this trial (Thal-SMD-20) are to evaluate the efficacy and tolerance of     lower doses thalidomide in low risk MDS patients with transfusion-dependant anemia.   "
199273|NCT00455923|"     An 18 months randomised double-blind study with two parallel arms with start dose of inhaled     SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be     up-titrated until well controlled is achieved, After 6 months the treatment continues without     changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that     the combination therapy with SERETIDE controls mild persistent asthma better than inhaled     corticosteroids(FLIXOTIDE) alone.   "
199274|NCT00455936|"     The investigators will conduct the randomized trial to determine the role of Gefitinib     monotherapy as first-line setting in adenocarcinoma patients with no history of smoking, as     compared with the standard combination chemotherapy.      This is a randomized, open label, parallel group, phase III study in never-smokers with     advanced or metastatic adenocarcinoma of lung.      After stratification by gender, performance status, and disease stage, patients will be     randomized to one of the two treatment arms to receive either gefitinib or standard     chemotherapy until clinical or objective disease progression, unacceptable toxicity or     patient's refusal, whichever is sooner. The chemotherapy will be administered for no more     than nine cycles.   "
199275|NCT00455949|"     Analyze the possible effect of the progesterone levels of the hCG administration on the     oocyte embryo quality. The primary endpoint of this study is the pregnancy rate.   "
199292|NCT00456183|"     This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who     are latently infected with M.tb. A single vaccination with MVA85A, when administeredat a dose     of 5 x 107pfu intradermally, is safe in both mycobacterially naïve individuals and those     previously vaccinated with BCG. We will use the same vaccination regime in this study.     Subjects will be defined as being latently infected if they have a positive elispot response     to ESAT6 or CFP10. Subjects will be identified from TB contact clinics.   "
199276|NCT00455962|"     The purpose of this study is to attempt to determine why estrogen levels are increased in     African-American women as compared to Caucasian women by evaluating estrogen feedback on the     brain. African-American women have increased bone mineral density, higher rates of twins,     greater incidence of fibroids, and increased incidence of breast cancer below 40 years of age     as compared to Caucasian women. These traits or illnesses are all believed to be     estrogen-dependent. In fact, previous research has demonstrated increased estrogen levels in     African-American women as compared to Caucasian women. However, the reason for these     differences in estrogen levels has not been studied in humans. One possibility is that     estrogen feedback on the brain differs between African-American and Caucasian women. Two     small glands in the brain (hypothalamus and pituitary) respond to estrogen. The hypothalamus     secretes GnRH (Gonadotropin-Releasing Hormone) that signals the pituitary to secrete the     reproductive hormones, LH (Luteinizing Hormone) and FSH (Follicle Stimulating Hormone). These     hormones act on the ovaries and signal the ovaries to produce estrogen and progesterone.     Estrogen in the bloodstream then acts on the brain to stop this system when the blood has     enough estrogen levels. This is called estrogen feedback. This study will determine whether     there are differences in estrogen feedback between African-American and Caucasian women.   "
199277|NCT00455975|"     This trial will examine the effectiveness and the side effects of 2 higher dosing schedules     of bevacizumab in patients that have advanced clear cell renal carcinoma.   "
199278|NCT00455988|"     In order to manage of type 2 diabetic patients with irregular lifestyle, developement of an     appropriate questionnaire to evaluate a regularity of lifestyle is necessary.   "
199279|NCT00456001|"     Patients at BWH receiving unfractionated heparin or enoxaparin who subsequently develop     heparin induced thrombocytopenia will be identified via a computer generated report designed     for the purposes of this study.      Subsequently, we will compare the heparin induced thrombocytopenia rates associated with     heparin and low molecular weight heparin usage as well as evaluate the economic and long-term     clinical burden of heparin induced thrombocytopenia.   "
199280|NCT00456014|"     This study will use pre-treatment positron emission topography and functional magnetic     resonance imaging scans of the brain to predict the most effective antidepressant treatment     for people with major depressive disorder.   "
199281|NCT00456027|"     This is a study to investigate the safety of 20ug Diamyd® (rhGAD65 formulated in     Alhydrogel®), administered subcutaneously four weeks apart in patients with Latent Autoimmune     Diabetes in Adult (LADA).   "
199282|NCT00456040|"     The purpose of this study is to describe the characteristics of patients with amyloidosis and     severe heart failure being evaluated for cardiac and stem cell transplantation.   "
199283|NCT00456053|"     The purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of     patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.   "
199284|NCT00456066|"     Distal embolization can occur during coronary angioplasty performed in the acute phase of     myocardial infarction and is associated with poor long-term outcome. We hypothesize that the     use of a system allowing thrombus aspiration before angioplasty and stent implantation will     limit infarct size and its severity.   "
199285|NCT00456092|"     This study is to look at the preliminary efficacy and safety of CC-10004 vs placebo in     patients with active psoriatic arthritis. The pharmacokinetics of the compound in patients     will also be explored, and biopsies will be taken of the skin and the knee synovium to look     at the activity of the drug in the relevant tissues.   "
199286|NCT00456105|"     Diabetes is a very common illness. Approximately 4% of British Columbians have diabetes.     However, at least 20% of people admitted to acute care hospitals have diabetes. People with     diabetes are at a higher risk for developing complications after surgery including infection     and prolonged hospital stay, especially if blood sugars are high.      The researchers are testing a Diabetes Action Team to see if their involvement in patient     care after surgery improves blood glucose control, duration of stay in hospital, and     infection rates.   "
199287|NCT00456118|"     Justification:      We have recently demonstrated that maternofetal alloimmunization was not limited to blood     cells: maternal alloimmunization against a glomerular podocyte antigen expressed by the     placenta can induce neonatal membranous glomerulonephritis.      Early recurrent pregnancy losses, preeclampsia and intervillositis are obstetrical     pathologies which share an anomaly of placentation. Pathophysiology of these diseases is not     yet fully understood; nevertheless the hypothesis of an incompatibility between mother and     child is often mentioned. The aim of this project is to detect and study the cases of     recurrent pregnancy losses, preeclamspia and intervillositis which could be induced by     tissular maternofetal alloimmunization.      Materials and methods:      Patients suffering from recurrent pregnancy losses of unknown origin, preeclamspia or     intervillositis will be included in this project. Mothers’ sera will be studied by indirect     immunofluorescence and Western Blot on placental biopsies from different origins and     gestational ages. This stage will enable us to detect possible maternal allo-antibodies.     After detecting and revealing antibodies, nature of the target antigen will be identified by     immunoprecipitation of placental extracts, using the positive sera. Immunoprecipitation will     be followed by a mass spectrometry analysis of detected proteins.      Expected results:      This study will enable us:        -  to detect new cases of tissular maternofetal alloimmunization        -  to improve our knowledge of mechanisms leading to anomalies of placentation        -  to carry out a specific, preventive therapeutic approach for cases induced by tissular          alloimmunization.      Key words:      Recurrent pregnancy losses, Preeclampsia, Intervillositis, maternofetal alloimmunization.   "
199288|NCT00456131|"     This is a nutrition and behavior-based intervention conducted at Drexel University and the     University of Pennsylvania with college women during their freshman year. It involves     attending groups where life skills and eating behaviors are taught to help them control their     weight and physical health.   "
199289|NCT00456144|"     The purpose of this research study is to find out if a certain type of hormone therapy,     gonadotropin-releasing hormone agonist (GnRH agonist), affects the way the body produces and     responds to insulin. The investigators will evaluate the changes in insulin sensitivity     during and after GnRH agonist treatment for prostate cancer. The investigators are assessing     the possibility that treatment-related insulin resistance may contribute to the risk of     diabetes and/or cardiovascular disease in men with prostate cancer.   "
199293|NCT00456196|"     More than 5 years ago the DVT FREE Registry was conceived. Its database consists of 5,451     ultrasound-confirmed DVT patients from 183 institutions. This database is rich in information     of critical importance to health care providers. The information contained within the     database will be revisited to provide more detailed analyses which will be used for risk     factor assessment and for decision-making regarding the implementation of VTE Prophylaxis.   "
199294|NCT00456209|"     The purpose of this phenomenological study is to discover and illuminate the experiences of     adolescents in the treatment process of cancer and the meanings they attach to these     experiences, while maintaining their daily routines. The focus area of interest lies in the     impact side-effects (psychological and physical) which these treatments may have on an     individual's ability to participate with peers, maintain social activities, and be involved     in daily occupation(s).   "
199295|NCT00456222|"     The purpose of this study is to investigate whether sleep disruption affects menstrual cycle     timing   "
199296|NCT00456235|"     The aim of this project is to determine whether, in liver transplant patients with side     effects due to ICN, the use of MMF in monotherapy can be optimised by dose adjustment based     on the area under the curve (AUC) of mycophenolic acid (MPA). It involves a multicentre phase     IV trial with direct individual benefit.      A population of 130 liver transplant patients at 2 to 10 years post-transplant, showing     significant clinical ICN side effects and being given bitherapy by ICN +MMF will be included     and randomised 1:1 in two arms:        -  Arm 1: progressive interruption of ICN after obtaining an AUC of MPA of 50 mg.h/l,          followed by MMF monotherapy with dose adjustment based on the AUC of MPA,        -  Arm 2: continuation of the ICN+MMF bitherapy without MMF therapeutic drug monitoring.      The main judgement criterion will be the incidence of acute rejection in the 2 groups at 6     months. The secondary judgment criterion will be the evaluation of the benefit of stopping     ICN on the side effects caused by these drugs.   "
199297|NCT00456248|"     This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with     Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and     Ribavirin therapy. The study will be conducted at approximately 50 sites across the United     States.   "
199298|NCT00456261|"     This trial will look at 2 different drug combinations that have well known safety profiles     and are known to be active against non small cell lung cancer and combine them with     bevacizumab, an experimental drug that has shown effectiveness when added to other drug     combinations for advanced non-small cell lung cancer. The primary objective in this study is     to see how well this combination of drugs keeps the cancer from getting worse in this elderly     population of non-small cell lung cancer patients.   "
199299|NCT00456274|"     The purpose of the study is to explore the way in which gonadotropins (pituitary hormones)     are released into the body. The knowledge acquired in this study will be used for the     diagnosis and treatment of reproductive endocrine disorders.      We seek to investigate the baseline characteristics of the GnRH-induced gonadotropin     pulsations of patients with the following diagnoses:        -  Hypothalamic Amenorrhea (HA)        -  Idiopathic hypogonadotropic hypogonadism (IHH)        -  Polycystic ovarian disease (PCOD)        -  Acquired hypogonadotropic hypogonadism (AHH)        -  Premature Ovarian Failure (POF)      **WE ARE CURRENTLY RECRUITING ONLY SUBJECTS WITH A DIAGNOSIS OF IHH.**      This has been an extremely productive and pivotal protocol in the studies of female     reproductive physiology and pathophysiology and continues to be critical for defining the     neuroendocrine abnormalities in patients with reproductive disorders. In some cases, it is     also helpful in the planning of subsequent therapy if so desired.      It is important to note that minors have been included in this protocol, as many patients are     extremely anxious to know more about their neuroendocrine disorder. With minors who would     like to know if their disorder is correctable, this protocol may be followed up with     administration of pulsatile gonadotropin-releasing hormone (GnRH).   "
199300|NCT00456287|"     The objective of the study is to define and compare clotting- fibrinolysis patterns, platelet     function markers and endothelial dysfunction in patients with SAHS before and after treatment     and normal controls age and weight matched.   "
199301|NCT00456300|"     The purpose of this study is to see if giving exenatide and insulin before a meal would lower     blood sugars after the meal. This study may help in developing new treatments to help control     high blood sugars after meals. This may help improve overall blood sugar control and prevent     the long-term problems of diabetes.   "
199302|NCT00456313|"     This multi centre, double blind, comparator controlled, parallel group study is to determine     whether asthma treatment with high doses of fluticasone propionate (FP) redirects a Th2/     eosinophil response towards a more treatment resistant neutrophil/ monocyte response and     whether this occurs to a lesser extent in asthmatic subjects treated with the combination     product of salmeterol and fluticasone propionate (SFC). The primary endpoint is the mean     change in priming of blood neutrophils assessed by marker A17. After a run-in period of 4     weeks subjects will enter a 24 weeks high dose treatment (FP 500 mcg bd) or a 12 week     medium-dose treatment with FP 250 mcg bd followed by a 12 week treatment with SFC 50/ 250     mcg. At the visits lung function measurements, ACT, eNO measurements and a blood sample will     be performed. A total of 50 randomised subjects are planned to be recruited in this study   "
199303|NCT00456326|"     The purpose of the Heparin Induced Thrombocytopenia Registry is to explore the frequency of     heparin-induced thrombocytopenia (HIT) at Brigham and Women's Hospital and to assess its     mortality rate. Retrospective 3 years, looking forward prospectively.   "
199304|NCT00456339|"     The purpose of this study is to investigate the effect of treatment with a steroid and     antibiotic on the size of the tonsils and symptoms of children with OSAS.   "
199305|NCT00456352|"     Evaluation of duodenal exclusion procedure for the treatment of T2DM   "
199306|NCT00456365|"     The purpose of this study is to determine whether the medication pravastatin will ameliorate     renal and cardiovascular disease over a 3-year period in children and young adults with     autosomal dominant polycystic kidney disease (ADPKD).   "
199307|NCT00456378|"     The purpose of this study is to establish the safety and effectiveness of the DIAM™ Spinal     Stabilization System in the treatment of moderate single-level lumbar degenerative disc     disease.   "
201908|NCT00489853|"     The purpose of this study is to investigate the effect on exercise tolerance, lung function     and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic     obstructive pulmonary disease.   "
199308|NCT00456391|"     Pediatric patients are admitted to the emergency room for diverse causes, beside trauma,     patients can present with convulsions, suspicion of brain tumor or increased intracranial     pressure. In most of the cases a brain CT is performed even before physical examination by a     skilled neurologist. The amount of radiation that the children are exposed is equivalent to     100 plain chest X rays. The purpose of this tudy is to examinate in a retrospective study     what were the indications for CT study and what was the incidence of relevant abnormal     findings that required emergency intervention or referral.   "
199309|NCT00456404|"     To evaluate the effectiveness of a topical preparation of peppermint water in comparison with     that of expressed breast milk for the prevention of nipple cracks in primiparous     breastfeeding women.   "
199310|NCT00456417|"     The underlying goal of this study is to assess 123-I MNI-187 SPECT imaging as a tool to     detect ß-amyloid deposition in the brain of AD research participants and age- and     gender-matched healthy subjects.   "
199311|NCT00456430|"     The purpose of this study is to find out what parts of the brain have increased or decreased     activity when people are depressed and how antidepressant medicine changes this activity in     depressed patients.In particular, this study will investigate whether variation in the     serotonin transporter gene can affect the response to escitalopram as measured by clinical     interview and MRI scan. We will measure activity in different parts of the brain, while     subjects see pictures, using Magnetic Resonance Imaging (MRI) scan. There will be three MRI     scans; one before we start any medication, one during the study after 3 weeks of treatment     and one after six more weeks of treatment. Treatment will consist of Escitalopram.     Additionally a blood sample will be taken for genetic testing. The genetic samples collected     are to look at variation in a gene (serotonin transporter gene), which affects the     functioning of the chemical serotonin in the brain.   "
199312|NCT00456443|"     Patients diagnosed as having hemoglobinopathies are exposed to serious bacterial infections,     principally those patients that underwent splenectomy. Since the introduction of anti     pneumococcal vaccine the incidence decreased significantly but other bacteria besides     encapsulated bacteria takes place as principal cause of invasive infections. The purpose of     this study is to analyse in a retrospective study the incidence of those infections in a     group of patients suffering from thalassemia and sickle cell anemia treated in our clinic.   "
199313|NCT00456456|"     Online survey for 11-17 year olds about behavior, sleep, and food consumption patterns. This     survey can be completed on any computer that has internet access.   "
199314|NCT00456469|"     Study based in Southern Ethiopia Purpose - to explore if children in contact with adults with     TB have positive acute reactants such as IFN-y and other cytokine responses; if these     responses discriminate between high and low risk of disease progression and whether these     could be incorporated into improved diagnostic approaches.   "
199315|NCT00456482|"     This is a multi-center, randomized, double-masked, controlled study to evaluate the safety     and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects     with non-infectious uveitis affecting the posterior segment of the eye. An additional     objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.   "
199316|NCT00456495|"     The purpose of this study is to test the safety and tolerability of subconjunctival injection     of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and     severity of adverse events.      Our secondary objective is to assess the efficacy of ranibizumab treatment on malignant     conjunctival neoplasia by evaluating tumor destruction or reduction as documented by     slit-lamp photography and ultrasonographic imaging and the regression of blood vessels.   "
199317|NCT00456508|"     The purpose of this study is to evaluate the efficacy and safety of repeated doses of     ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE     patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4)     trial will be followed up and treated for subsequent attacks in this trial.   "
199318|NCT00456521|"     The purpose of this study is to determine whether a combination of naltrexone SR and     bupropion SR is safe and effective in treating obesity and leads to greater weight loss when     given with a group lifestyle modification program than with group lifestyle modification     alone.   "
199319|NCT00456534|"     The purpose of the experiment is to examine the effect of smoking on how individuals     recognize and interpret sensory information.   "
199320|NCT00456547|"     The purpose of this study is to examine components of the coagulation system in women     undergoing postpartum hysterectomy and to compare laboratory parameters of coagulation in     these women to women at increased risk for a postpartum hysterectomy, but who do not have     postpartum hemorrhage and a postpartum hysterectomy. During normal pregnancy, the hemostatic     balance tips toward hypercoagulation. Non-obstetric surgical blood loss is associated with     increased coagulation activity. We have observed that women undergoing a postpartum     hysterectomy become hypocoagulable secondary to a consumptive coagulopathy and/or excessive     fibrinolysis. This coagulopathy may lead to the administration of multiple blood products.     Worldwide, postpartum hemorrhage is a leading cause of maternal death. Plasma levels of     tissue plasminogen activator, urokinase plasminogen activator and their inhibitors increase     during pregnancy. During labor and delivery activation of coagulation occurs with consumption     of platelets, coagulation factors and inhibitors. Obstetric complications during delivery can     excessively activate the coagulation system and disseminated intravascular coagulation may     ensue. Current treatment for postpartum coagulopathy is non-specific and primarily consists     of replacing blood components. If specific causes or markers of abnormal coagulation can be     identified in women at risk, then it might be possible to target (with specific medications)     specific abnormalities early in the process and decrease hemorrhage and the need for blood     transfusions.   "
199321|NCT00456560|"     The purpose of this study is to evaluate the effects that paroxetine and fluvoxamine have on     the way the body distributes, breakdowns and eliminates AV650. In addition, information about     any side effects that may occur will also be collected.   "
199322|NCT00456573|"     The purpose of this study is to compare the cytokine profile of tonsillar and peripheral     blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the     blood mononuclear cell cytokine secretion profile between patients with obstructive sleep     apnea and controls without apnea.   "
199325|NCT00456612|"     Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses     (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly-     particularly in patients who are generally in poor performance status (KPS<70). Fractionated     Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor     control in a much shorter and tolerable schedule improving their quality of their short life.      To assess the tolerability of Cyberknife Radiosurgery for High Grade Gliomas in Elderly with     poor performance status.      Secondary:      Assessment of local control rate, progression free survival, overall survival, quality of     life and toxicity and steroid dependence in this population with this regime.   "
199326|NCT00456625|"     The current study will evaluate immunological memory to hepatitis B antigen in subjects who     received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in     the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values     at the previous long-term time point. All participating subjects will receive a challenge     dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of     this study. No new subjects will be recruited in this long-term follow-up study. Blood     sampling will be done one month after the administration of the challenge dose. The Protocol     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
199327|NCT00456638|"     The purpose of this study is to determine whether epidural Depodur alleviates the pain of     OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and     other tissue insults, as well as the induced inflammatory system and effects from prolonged     ventilation in the ICU setting.   "
199328|NCT00456651|"     The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome     have different pattern in the secretion of hormones.      The chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome     (SAHS) may affect the central mechanisms that regulate nutritive behavior and energetic     balance, causing an alteration in the secretion of hormones that favour the appearance and/or     development of obesity.   "
199329|NCT00456664|"     Various diagnostic methods are available for CMV infection. But none of them could be a     standard and highly valuable. Our first goal is to setup a series of molecular diagnostic     tools for HIV-1 infected person. By using these tools, physicians can easily select cases     with CMV disease or immune restoration inflammatory syndrome (IRIS) to enroll this study.     Furthermore, we will seek for a predict marker for CMV reactivation, CMV disease and IRIS.     Finally, our research will focus on the mechanism of the IE gene alternative splicing between     lytic and latent stage.   "
199330|NCT00456677|"     Trial of effects of minocycline as add-on therapy to adults with asthma with a history of     requiring at least one episode of oral steroid therapy to control the disease.   "
199331|NCT00456690|"     B Thalassemia patients developed short stature and low weight in spite no evident endocrine     abnormalities. One hypothesis is that they developed some degree of malnutrition,then the     purpose of this study is to assess the nutritional status before nutritional intervention and     after one year. Siblings of the patients will serve as a control group.      BMI, lipid and endocrine profile and leptin levels will be analysed in the study group only.   "
199332|NCT00456703|"     Liberal intravenous fluid resuscitation during open abdominal surgery may predispose the     patients to multiorgan dysfunction, prolong hospital stay and increase postoperative     morbidity. The main aim of the study is to assess the safety and feasibility of restricted     fluid regimen in open abdominal bowel surgery.   "
199333|NCT00456716|"     Open label study of sorafenib   "
199334|NCT00456729|"     Infants should receive prophylacatic iron supplementation since age 4 months till one year.     Patients suffering from malabsorption, mainly Giardia infestation may develop iron deficiency     resistent to further iron treatment. The purpose of this study is to assess the incidence of     malabsorption in those infants and to examine the results of empiric treatment with     metronidazole.   "
199335|NCT00456742|"     The purpose of these questionnaires is to give us an overview of how GAD has affected your     life, and perhaps also to give us some clues about things that may have set you up to     experience GAD.   "
199336|NCT00456755|"     Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The     conventional therapies are effective in alleviating symptoms but the efficacy are limited and     not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese     herbal formula, has been used for AR for centries. Our study purpose is to evaluate the     clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis     (PAR).      Hypothesis: the classical herbal formula would improve the symptoms of PAR patients and     change some immunological parameters in the peripheral blood when comparing with the placebo.   "
199337|NCT00456768|"     The purpose of these questionnaires is to give us an overview of how panic has affected your     life and perhaps also to give us some clues about things that may have set you up to     experience panic.   "
199338|NCT00456781|"     This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product     used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright     Medical Technology, Inc., Arlington, TN) is a biologic tissue that is derived from human     dermis. The primary purpose of this study is to determine whether rotator cuff repair     augmentation using GraftJacket allograft provides a viable alternative, based on observed     clinical outcomes, versus outcomes traditionally achieved with suture and anchor repairs. The     study will secondarily investigate the difference in outcomes in patients treated     arthroscopically versus open. This study will report patient progress and results at early (6     month) and late (2 year) time points in patients treated for large and massive reparable     rotator cuff tears (>3cm). A reparable tear is defined as a tear of the rotator cuff where it     is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus     without excessive tension. Restoration of rotator cuff integrity, clinical outcomes and     re-tear rate will be included in the study evaluations.   "
199339|NCT00456794|"     A 12-week, multicenter, double-blind, randomized study designed to evaluate the safety and     efficacy of 20 and 60 mg/day istradefylline compared with placebo in subjects with OFF-time     phenomena and advanced Parkinson's disease treated with levodopa/carbidopa.   "
199340|NCT00456807|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the     uterus or womb). This infection may go away by itself, but if it does not go away (this is     called persistent infection), it can lead in women over a long period of time to cancer of     the cervix. This study will supplement an ongoing study evaluating the safety, efficacy and     immunogenicity of the vaccine in women aged 26 years and above. This study will therefore     assess additional immunogenicity parameters of the vaccine in women from selected     investigative sites.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
199341|NCT00456820|"     The purpose of this study is to find out differences in activation of mood regulating areas     of the brain in response to negative and positive pictures, before and after 6 weeks of     additional Wellbutrin XL treatment. Participants should have been treated for depression with     an SSRI medication (e.g., Prozac, Zoloft, Paxil, Celexa or Lexapro) and have decreased     depression symptoms but also be experiencing side effects of medications such as sexual side     effects and feelings of apathy (indifference, lack of interest) and lack of full emotional     response. We will first take a brain scan to measure activity in different parts of the     brain, while subjects are seeing pictures, using Magnetic Resonance Imaging (MRI) scan. Then     we will add Wellbutrin XL - another well-known antidepressant that acts by increasing the     chemical dopamine in the brain, to subjects' treatment. Wellbutrin addition is useful in     decreasing the sexual side effects of SSRIs. After treatment with Wellbutrin XL for 6 weeks     subjects will have a second MRI scan with picture rating.   "
199342|NCT00456833|"     This study aims to assess the value of combined treatment with RAD001 and erlotinib in     patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic     therapy.   "
199343|NCT00456846|"     The purpose of this study is to determine the toxicity and anti-tumor activity of     nab-paclitaxel 100mg/m^2 administered weekly in a 4-week cycle as first line therapy to     patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy     and patients who did not receive taxanes as part of their adjuvant therapy.   "
199344|NCT00456859|"     The CAP-KD trial is a prospective, multicenter, randomized, open-label, two-arm, parallel     group comparison clinical trial and will be conducted as a researcher-directed study to     assess the efficacy of Kremezin in preventing the progression of CKD. We compare two groups     of patients: those receiving conventional treatment alone and those receiving such treatment     paired with Kremezin.   "
199345|NCT00456872|"     Oncology patients require numerous invasive procedures throughout their disease process     including bone marrow biopsies (BMB). BMB.s are performed by a significant number of health     care providers. One of the biggest concerns for health care providers is to improve patient     comfort. The goal of this study was to reduce pain during BMBs.      Specific aims of the study were to determine if there is a difference in patients' perceived     pain during injection of the pre-procedure anesthetic when buffered versus unbuffered     lidocaine is administered to patient's receiving bone marrow biopsies.      A double blind, experimental crossover design was used to examine the difference in pain     levels when using buffered versus unbuffered lidocaine prior to the bilateral bone marrow     biopsy procedure. Based on a power analysis for a paired t-test, a convenience sample of 48     patients was enrolled into the study. Patients served as their own control. The site of first     biopsy, and which lidocaine solution was administered first, were randomized. A 100mm visual     analogue scale (VAS) was used to measure pain.      All data has been collected, are currently under analysis, and results will be completed in     August 2006. Differences in groups will be examined using a paired t-test. A demographic     questionnaire was used to gather select demographic variables. Correlative studies will be     done to examine the relationship between the patient's perceived pain scores and several     exploratory variables. Results of this study may change the current type of anesthetic used     pre-BMBs thus improving patient comfort.   "
199346|NCT00456885|"     This study will look at the effect of exenatide, a drug which has been approved for the     treatment of type 2 diabetes, on body weight, appetite and energy expenditure among     moderately obese women without diabetes.      The study is 35 weeks long and includes 19 outpatient visits. Participants will receive     exenatide for 16 weeks and placebo for 16 weeks with a 3 week rest period in between. Neither     participants nor investigators will know whether exenatide or placebo is being administered.     Participants will be started randomly on either exenatide or placebo.      Our hypothesis is that treatment with exenatide will curb appetite and lead to weight loss     and may lead to changes in energy expenditure.   "
199347|NCT00456898|"     To evaluate the effects of multiple oral doses of desvenlafaxine sustained release (DVS SR)     and paroxetine on the biotransformation of codeine to morphine in healthy subjects. To assess     the safety and tolerability of DVS SR and paroxetine when coadministered with codeine to     healthy subjects.   "
199348|NCT00456911|"     We hypothesize that Family Dietary Coaching for one school year will allow a nutritional     shift towards following recommendations and improve health indicators in free-living children     and adults.   "
199349|NCT00456924|"     The purpose of the present study is to evaluate continuous administration of low doses of     VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid     hormone parameters.   "
199350|NCT00456937|"     SSRI's has been demonstrated to be partially effective in schizophrenia and OCD. We therefore     suggest that Escitalopram up to 20 mg /d in those patients could be effective in reducing     obsessive compulsive symptomatology   "
199359|NCT00457054|"     The purpose of this study is to find out what parts of the brain have increased or decreased     activity with individuals who have bipolar disorder and how medicine changes this activity in     bipolar subjects. Another purpose of this study is to compare data obtained from bipolar     depressed subjects with data obtained from healthy subjects. In this study we will measure     activity in different parts of the brain, while participants see pictures, using Magnetic     Resonance Imaging (MRI) scan. We will do two MRI scans with each subject before and after     treatment for eight weeks with a standard bipolar disorder medication called lithium.   "
199624|NCT00459641|"     This is a randomised, controlled, open-label study of a single intralesional administration     of I-040302 or a single bone marrow aspirate or a single steroid injection     (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance     imaging (MRI) in the diagnosis of a solitary bone cyst.   "
199351|NCT00456950|"     Despite advances in prevention and treatment, clinical manifestations of atherosclerosis     (e.g. myocardial infarction, stroke) remain the largest cause of mortality in the Western     world. The occurrence of acute ischemic syndromes, including unstable angina and myocardial     infarction, is highly associated with atherosclerotic plaque morphology.      Magnetic resonance (MR) imaging is able to noninvasively depict the lumen of coronary     arteries without the need for ionizing radiation. In addition, MR imaging is able to generate     soft-tissue contrast unlike any other imaging modality. It has been shown in the aorta and     carotid artery that MR imaging is able to identify different atherosclerotic plaque     components in vivo. Similar MR imaging techniques are becoming available to visualize the     coronary arterial wall and preliminary studies have shown the feasibility of MR coronary     vessel wall imaging in humans.      The overall aim of the current study is to identify in vivo MR coronary vessel wall and     plaque features that are associated with acute coronary syndromes. This study is divided into     2 substudies:        1. Detection of atherosclerosis in the coronary vessel wall with contrast-enhanced MR          imaging in patients with coronary artery disease and age-matched healthy volunteers.        2. Characterization of coronary vessel wall plaque morphology in patients with stable and          unstable angina: validation of MRI with the current standard of reference intravascular          ultrasound (IVUS).   "
199352|NCT00456963|"     Background. Antihypertensive therapy with ß-blockers (ßBs) and diureticts (Ds) is accompanied     by a higher incidence of diabetes mellitus (DM) than therapy with ACE-inhibitors (ACEIs) or     angiotensin-receptor blockers (ARBs). Whether this difference is due to an antidiabetogenic     action of ACEIs and ARBs or to the fact that these agents are free of the diabetogenic     activity of ßBs and Ds is unknown. Prevention of DM as well as of HT is of primary health     concern.      Objectives. The primary objective of PHIDIAS is to test whether in individuals with     components of metabolic syndrome making them predisposed to DM and HT, addition of either an     ACEI or an ARB to periodically reinforced lifestyle counselling can reduce 1) onset of DM and     2) onset of HT significantly more than lifestyle plus placebo. Secondary objectives are 1)     comparing the antidiabetogenic effects of ACEI and ARB, and 2) investigating whether the     effects of ACEI and ARB on DM and HT persist at least 6 months after treatment withdrawal.      Methods. PHIDIAS is a prospective, double-blind, placebo-controlled 3-arm comparison trial.     300 general practitioners (members of SIMG with the assistance of hospital centres of SIIA)     will randomise 6000 untreated individuals aged 40-75 years, with SBP 130-139 or DBP 85-89     mmHg, fasting glucose (FG) 100-125 mg/dl, waist circumference >= 102 (M) or >= 88 cm (W), to     three blinded treatments, given in addition to lifestyle advise: 1) Placebo; 2) the ACE     Enalapril (10 mg, then 20 mg od); 3) the ARB Losartan (50 mg, then 100 mg od).Double-blind     treatment will be maintained until 500 cases of DM are observed (presumably average of 36     months) (Treatment Phase: control visits, BP, FG every 6 months). This will be followed by a     6-month Withdrawal Phase (active treatment substituted by placebo). Primary outcomes are DM     (FG >= 126 mg/dl) and HT (SBP >= 140 or DBP >= 90 mmHg) on 2 consecutive visits. PHIDIAS will     be governed by a Steering Committee assisted by a blinded Event Adjudicating Committee and an     independent DMSB.      Expected results. The sample size is adequate (alfa 5%, power 90%) to evaluate whether     incident DM (expected rate 3.5%/year) or incident HT is reduced 25% by ACEI and ARB versus     placebo (primary hypothesis) and whether either the ACEI or the ARB reduces incident DM by     30% more than the other agent.   "
199353|NCT00456976|"     Antipsychotic drugs are effective in treating the positive symptoms of schizophrenia; however     their efficacy in treating negative symptoms is limited. This study wants to evaluate     efficacy of selegiline augmentation of antipsychotic medication to treat negative symptoms in     inpatients with chronic schizophrenia. With randomized clinical trial two groups of patients     will select to receive selegiline or placebo.      Primary end point is decreasing in negative symptoms in case group. Inclusion criteria : 1-     Patients with moderate to severe negative symptoms 2- Patients with at least one year     antipsychotic drug therapy, at the current dose >= 1 month. 3- No other psychotropic drugs     during past month. Exclusion criteria: 1- Severe major depressive disorder, substance abuse,     severe positive symptoms of schizophrenia, Treatment of MDD with antidepressant drugs during     past month.   "
199354|NCT00456989|"     This clinical research study is being done because there is no effective treatment for     advanced androgen-independent prostate cancer. This study will determine if the combination     of medications (Taxotere and Doxil) are effective in this kind of cancer.   "
199355|NCT00457002|"     The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep     vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within     patients hospitalized for acute medical illness, and to learn how apixaban compares to     enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be     studied.   "
199356|NCT00457015|"     The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide)     versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.   "
199357|NCT00457028|"     The purpose of these questionnaires is to give us an overview of how OCD has affected your     life and perhaps also to give us some clues about things that may have set you up to     experience OCD.   "
199358|NCT00457041|"     This pilot study will explore the usefulness of a series of questions asking about views of     research from the perspective of minority and economically disadvantaged research     participants. Racial and ethnic minorities are consistently under-represented in clinical     research. This under-representation has been attributed primarily to an unwillingness to     participate in research because of mistrust in the research establishment, especially in     light of widely known historical examples of abuse. However, more recent data suggests that     not being invited to participate in research, or stringent entry criteria, may contribute     substantially to the low numbers of ethnic minority research participants. The perspectives     of racial and ethnic minorities who are knowledgeable about or participating in research are     important to understanding the kinds of vulnerabilities that exist and any important barriers     to participation.      People 18 years of age and older from the Cardozo clinic in Washington, D.C., who are     enrolled in the National Institute of Arthritis and Metabolic Studies' natural history study     are eligible to participate in this protocol.      Participants are interviewed with questions about their own experiences in clinical research     as well as some hypothetical research studies. Questions include participants' general views     of clinical research, perceived risks and benefits of research, alternatives to research     participation, the limits of what they would be willing to accept in research and types of     research or research procedures they might perceive as unfair.   "
199370|NCT00457197|"     The purpose of this study is to find out whether an investigational drug called quetiapine     can treat bipolar disorder, improve mood and reduce alcohol use and craving.   "
199371|NCT00457210|"     The cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain     will be assessed at 3 time points before and after the treatment.   "
199360|NCT00457067|"     This study will examine whether the drug ranibizumab is an effective treatment for macular     telangiectasia, a condition in which existing blood vessels near the macula (the back part of     the eye responsible for sharp central vision) become dilated and twisted, and new abnormal     blood vessels may form under the retina. Both the existing dilated vessels, as well the new     subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This     study will see if ranibizumab can slow or stop the leakage and growth of new vessels forming     under the retina.      Patients 18 years of age and older who have macular telangiectasia in both eyes and new blood     vessel formation under the retina in at least one eye may be eligible for this study. Visual     acuity must be 20/40 or worse.      Participants receive at least four injections of ranibizumab into the eye over a 12-week     period. After the fourth injection, additional injections may be given every 4 weeks for up     to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab     treatment, patients undergo the following procedures:        -  Medical history and physical examination.        -  Eye examination, including dilation of the pupils and measurement of the fluid pressure          in the eye.        -  Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the          blood vessels in the eyes. Photographs of the retina are taken with a special camera          that flashes a blue light into the eye. The photos show whether any dye has leaked from          the vessels into the retina.        -  Indocyanine green angiography: This procedure identifies feeder vessels that may be          supplying the abnormal blood vessels. The test is similar to fluorescein angiography,          but uses a green dye and flashes an invisible light.        -  Autofluorescence imaging: This test examines how well the retina functions. The back of          the eye is photographed with a bright light.        -  Optical coherence tomography: This test measures retinal thickness. A light shined into          the eye produces cross-sectional pictures of the retina. The measurements are repeated          during the study to determine if retinal thickening is getting better or worse, or          staying the same.        -  Stereoscopic color fundus photography: The pupils are dilated and special photographs of          the inside of the eye are taken to evaluate the retina and measure changes that occur          over time. The camera flashes a bright light into the eye for each picture.        -  Follow-up visits: The doctor evaluates the effects of the study treatment before and          after each injection. Patients are contacted by phone 3 days after each injection to          check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after          the last treatment.   "
199361|NCT00457080|"     The aim of this study is to increase the detection of undiagnosed obstructive sleep apnea     (OSA) and secondly to increase the sensitivity for detection of respiratory depression (< 6     breaths per minute) in post operative patients on the general care nursing unit.   "
199362|NCT00457093|"     The purpose of this study that when studies using our method of dosing adjustments driven by     continuous glucose monitoring and because of the less variable glycemic effect of insulin     detemir, insulin detemir treated subjects will spend a significantly greater time in the     glucose target range than insulin glargine.   "
199363|NCT00457106|"     This study compares the efficacy of risperidone to that of paroxetine in the treatment of     panic attacks in patients with Panic Disorder and with Major Depressive Disorder with Panic     attacks and compares the side effect profile of risperidone vs. paroxetine in treatment of     panic attacks and compares response rates of risperidone vs. paroxetine in treatment of panic     attacks.   "
199364|NCT00457119|"     This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients     with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD     001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in     combination with carboplatin, paclitaxel and bevacizumab   "
199365|NCT00457132|"     Context: The many treatments and devices developed to unload the diseased articular surface     in knee osteoarthritis have provided limited solutions. A novel biomechanical device     comprising of four individually calibrated elements attached onto foot-worn platforms was     recently developed. This device is capable of such unloading during standing and walking,     simultaneously strengthening dynamic stabilizers and training neuromuscular control by     controlled biomechanical perturbations.      Objective: To asses the effectiveness of this device in reducing pain and improving function     in patients with knee osteoarthritis.      Design and Setting: Randomized, controlled and double blind prospective trial, conducted from     September 2005 to February 2006, in the Department of Orthopedics, Asaf Harofeh Medical     Center (Zerifin, Israel).      Patients: Sixty-one patients with diagnosed knee osteoarthritis who self-reported     moderate-to-severe level pain.      Interventions: Patients were randomly assigned into active and control groups and underwent 8     weeks of treatment. The active group was treated with the device and its four biomechanical     elements that had been individually calibrated to accommodate a pain-free joint alignment.     The control group was treated with the device’s platforms without the biomechanical elements.      Primary Outcome Measures: The patients were evaluated three times during the study: at     baseline, after 4 weeks and at the 8 week endpoint. Primary outcomes were the Western Ontario     and McMaster Osteoarthritis Index (WOMAC) and the Aggregated Locomotor Function (ALF)     assessment.   "
199366|NCT00457145|"     This study will examine whether the drug ranibizumab is an effective treatment for macular     telangiectasia, a condition in which existing blood vessels near the macula (the back part of     the eye responsible for sharp central vision) become dilated and twisted, and new abnormal     blood vessels may form under the retina. Both the existing dilated vessels, as well the new     subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This     study will see if ranibizumab can slow or stop the leakage and growth of existing, dilated,     macular vessels in cases where new vessel formation under the retina is absent.      Patients 18 years of age and older who have macular telangiectasia without new blood vessel     formation may be eligible for this study. Visual acuity must be 20/40 or worse.      Participants receive at least four injections of ranibizumab into the eye over a 12-week     period. After the fourth injection, additional injections may be given every 4 weeks for up     to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab     treatment, patients undergo the following procedures:        -  Medical history and physical examination.        -  Eye examination, including dilation of the pupils and measurement of the fluid pressure          in the eye.        -  Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the          blood vessels in the eyes. Photographs of the retina are taken with a special camera          that flashes a blue light into the eye. The photos show whether any dye has leaked from          the vessels into the retina.        -  Indocyanine green angiography: This procedure identifies feeder vessels that may be          supplying the abnormal blood vessels. The test is similar to fluorescein angiography,          but uses a green dye and flashes an invisible light.        -  Autofluorescence imaging: This test examines how well the retina functions. The back of          the eye is photographed with a bright light.        -  Optical coherence tomography: This test measures retinal thickness. A light shined into          the eye produces cross-sectional pictures of the retina. The measurements are repeated          during the study to determine if retinal thickening is getting better or worse, or          staying the same.        -  Stereoscopic color fundus photography: The pupils are dilated and special photographs of          the inside of the eye are taken to evaluate the retina and measure changes that occur          over time. The camera flashes a bright light into the eye for each picture.        -  Follow-up visits: The doctor evaluates the effects of the study treatment before and          after each injection. Patients are contacted by phone 3 days after each injection to          check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after          the last treatment.   "
199367|NCT00457158|"     The purpose of this study is to assess efficacy and safety of optional vena cava filter     implanted 3 months in prevention of recurrent pulmonary embolism in patients presenting with     acute pulmonary embolism associated with thrombotic risk factors   "
199368|NCT00457171|"     The aim of this double blind, placebo controlled, study is to evaluate activity consistent     with efficacy provided by 14 days administration of GI270384X, and to provide preliminary     pharmacokinetics and safety/tolerability of 14 days administration of GI270384X in patients     with mild to moderate active ulcerative colitis (UC).   "
199369|NCT00457184|"     Migraine was described as related to stroke in adults and children as well. Complete     thrombophilic status was not study in large groups of pediatric patients. The purpose of our     study is to assess the prethrombotic profile among children and teenagers diagnosed as     suffering from migraine attacks.   "
199374|NCT00457249|"     It is well recognized that older adults can contract pertussis, suffer its complications, and     unwittingly transmit it to close contacts, which may well include infants too young to have     received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in     the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for     administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no     upper limit on its age indication.      The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine     among individuals ≥ 65 years of age.   "
199375|NCT00457262|"     paraoxonase 1 is involved to prevent LDL and HDL oxidation,so increase of it's activity leads     to lower risk of coronary heart disease.In postmenopausal women ,we have decrease of     paraoxonase1 activity and soy proteins may increase paraoxonase1 activity   "
199376|NCT00457275|"     To evaluate the LDL-C lowering in south african patients with primary hypercholesterolaemia     after the addition of ezetimibe 10mg /day to ongoing therapy with a statin.   "
199377|NCT00457288|"     The current study will investigate the effects of TF002 on cutaneous mastocytosis or     cutaneous involvement of systemic mastocytosis as compared to clobetasol proprionate     (positive control) and a general skin care product without active ingredient targeting     mastocytosis (negative control) based on clinical effects on Darier´s signs and the     histological evaluation of mast cell numbers in skin bioptic material.   "
199378|NCT00457301|"     The objective of this study is to assess the effects of using HRQL measures in the clinical     care of pre- and post-lung transplant patients.      The hypotheses are that the inclusion of HRQL measures, the Health Utilities Index System     Mark 2(HUI2) and Mark 3 (HUI3), in routine clinical care of pre- and post-lung transplant     patients, will: 1) improve patient-clinician communication;2) affect patient management; 3)     improve patients' HRQL.   "
199379|NCT00457314|"     Mitochondrial myopathies include various inherited diseases that are caused by damage to the     mitochondria, energy-producing structures that fuel the body's processes. The main symptoms     are muscle weakness, reduced muscle mass, and difficulty with exercising. The purpose of this     study is to determine the effects of exercise training versus inactivity on mitochondrial     function in muscle and muscle performance in people with mitochondrial myopathies.   "
199380|NCT00457327|"     The purpose of this study is to determine whether protective ileostomy is required after low     anterior resection due to rectal cancer   "
199381|NCT00457340|"     To assess in patients with CAD [coronary artery disease] and an implantable defibrillator the     effect of atorvastatin 80 mg versus placebo on the first recurrence of a ventricular     arrhythmia (ventricular tachycardia or ventricular fibrillation requiring ICD [implantable     cardioverter defibrillator] intervention) within one year after randomization.   "
199382|NCT00457353|"     Primary:        -  To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea          in children      Secondary:        -  To evaluate the safety of Enterogermina® in acute diarrhea in Indian children   "
199383|NCT00457366|"     In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M.     Haloperidol cocktail (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to     be an effective treatment. However, since it is an intramuscular injection, it is more     complicated and perhaps less acceptable to patients as well as more likely to cause EPS     (extrapyramidal symptoms). Of late in our emergency room, we started using high dose     Quetiapine 300 mg PO to replace the cocktail for treating agitation. It has shown promising     results.      This study is designed to compare the efficacy and safety of Quetiapine with the routine     cocktail for treatment of agitation.      The primary purpose of this study is to determine the efficacy and safety of Quetiapine by     using high dose Quetiapine (300 mg) PO to treat agitated patients in the psychiatric     emergency room.      The secondary purpose is to test the immediate effect on agitation caused by illicit drug     abuse or the alcohol abuse.   "
199384|NCT00457379|"     Patients with coronary artery disease are characterized by an increased cardiovascular risk     and they often have low blood high density lipoprotein (HDL)-cholesterol levels or     HDL-cholesterol with modified vasculoprotective properties.      The purpose of the present study is to characterize the quality of HDL-cholesterol in     patients with coronary artery disease and normal blood HDL-cholesterol levels and to examine     the effect of exercise training on the vasculoprotective effects of HDL-cholesterol in these     patients. Additionally, the researchers aim to investigate the endothelial function,     oxidative stress and the regenerative capacity of the endothelial progenitor cells in     patients with coronary artery disease and the changes dependent on physical activity of     patients.   "
199385|NCT00457392|"     This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib     alone in patients with advanced/metastatic lung cancer who have received previous treatment     with a platinum-based regimen.   "
199386|NCT00457405|"     This study is performed to determine whether a seven day treatment with dipyridamole (slow     release, 200mg twice daily) can induce a protective effect against ischemia-reperfusion     injury, after ischemic exercise of the non-dominant forearm in healthy volunteers.   "
199387|NCT00457418|"     The purpose of this study is to establish the pharmacokinetics of PEG-Intron, administered at     a dose of 6 μg/kg/week for 8 weeks (induction treatment), followed by a dose of 3 μg/kg/week     for up to 252 weeks (maintenance treatment), in patients with high risk melanoma.   "
199388|NCT00457431|"     ILCOR Recommendations On the basis of the published evidence to date, the Advanced Life     Support (ALS) Task Force of the International Liaison Committee on Resuscitation (ILCOR) made     the following recommendations in October 2002: Unconscious adult patients with spontaneous     circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to     24 hours when the initial rhythm was ventricular fibrillation (VF).Such cooling may also be     beneficial for other rhythms or in-hospital cardiac arrest (Circulation. 2003;108:118-121).     This study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and     neurological outcome in patients after in-hospital cardiac arrest.   "
199452|NCT00451087|"     We assume the etiology of patellofemoral pain syndrome is related to mechanical properties of     tendon structures of the vastus medialis obliquus and vastus lateralis. Consequently, we will     measure the electromechanical delay and some viscoelastic parameters of the two muscles.     Besides, we will also investigate the effects of exercise training to the mechanical     properties of the muscles.   "
199389|NCT00457444|"     Primary Objective Comparison of the inhibition of the allergic response assessed by nasal     provocation test after epicutanous pollen allergen administration and placebo epicutaneous     administration.      Secondary Objectives Comparison of the efficacy of the placebo with that of the epicutanous     pollen allergen administration evaluated by visual analog symptom scales (nasal itching,     sneezing, rhinorrhea, conjunctival redness, and lacrimation, lung symptoms ), Comparison of     the inhibition of the allergic response assessed by skin prick test after epicutanous pollen     allergen administration and placebo epicutaneous administration.        -  Trial with medicinal product   "
199390|NCT00457457|"     This is a 12 week study in which different doses and formulations of UK-369,003 will be     administered to patients with a diagnosis of enlarged prostate. Patients will complete a     series of questionnaires before, during and after treatment to assess if UK-369,003 has     improved their urinary symptoms and erectile function . There will be several blood samples     taken during the study to asses the level of drug in the blood and correlate it with the     responses to the questionnaires.   "
199391|NCT00457470|"     This study will evaluate the safety and efficacy of AG-014699 in diabetic patients   "
199392|NCT00457483|"     High blood pressure is an important risk factor for diseases of heart and blood vessels like     myocardial infarction and stroke. Many patients are not treated to target blood pressures,     even though good blood pressure lowering drugs are available. Not all blood pressure drugs     are equally effective in individual patients.      We hypothesize that individual patient characteristics can predict the best response on     different blood pressure lowering drugs. In this study we will investigate whether a set of     patient characteristics (anthropometric and laboratory) obtained before treatment may predict     the blood pressure lowering response to representatives of two groups of drugs: those that     inhibit renin-angiotensin system activity and those that decrease blood volume.   "
199393|NCT00457496|"     The primary purpose of this study is to evaluate the effectiveness of a workplace cognitive     and physical program (Intervention), in reducing the frequency of head and neck pain   "
199394|NCT00457509|"     The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose     schedule in immunologically naïve adults against one vaccine formulation without adjuvant in     terms of tolerance and immunogenicity      Primary Objective:      To describe the safety profile and immunogenicity following each injection.   "
199395|NCT00457522|"     Although abuse by an intimate partner is very common and has serious negative effects on     women's health, few studies have been done to test ways to increase safety for women in     abusive relationships. This study will test a telephone intervention for women who report     physical, emotional, and/or sexual abuse within the past 12 months, to see if        -  women use more safety behaviors and access more community resources        -  chronic pain, fatigue, depressive, and post-traumatic stress disorder (PTSD) symptoms          affect a women’s ability to use safety behaviors and access community resources.   "
199396|NCT00457535|"     Responsiveness of recombinant human erythropoietin (rHuEPO) is known to be related with body     fatness in hemodialysis (HD) patients. Adiponectin (ADPN) is inversely associated with body     fat mass, and in healthy subjects, low ADPN is a predictor of mortality. Recently, higher     rHuEPO dose itself is demonstrated to be associated with poor prognosis. So, in this study,     we prospectively examined the relationship between rHuEPO dose, serum ADPN, and mortality in     patients beginning HD.   "
199397|NCT00457548|"     The purpose of this study is to determine if a brief counseling intervention, delivered by     telephone, is more effective than standard ED care, to reduce future alcohol related injuries     and alcohol related negative consequences, among patients treated in the ED for injuries from     an MVC and other injury mechanisms.   "
199398|NCT00457561|"     Decreased body fat mass, possibly mediated through the effects of elevated serum adiponectin     levels, may be associated with requirements for higher recombinant human erythropoietin doses     and a subsequent worse prognosis in patients beginning hemodialysis.   "
199399|NCT00457574|"     GMX1777 is a water-soluble, intravenously-administered prodrug of GMX1778. GMX1777 is rapidly     converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of     cell lines and models from different tumor origins.   "
199400|NCT00457587|"     Adrenocortical carcinoma (ACC) is a rare and heterogeneous malignancy with poor prognosis.     Surgical resection of the tumor is the treatment of choice. However, even after complete     resection more than 80 % of patients will experience recurrence of disease. Therefore, new     treatment options are urgently needed. This pre-clinical study try to lay the foundations for     a successful immunotherapy in patients with ACC.   "
199401|NCT00450424|"     RATIONALE: The use of a CD-ROM may help patients with colorectal cancer or a family history     of colorectal cancer make informed decisions about undergoing microsatellite instability     (MSI) testing.      PURPOSE: This randomized clinical trial is studying an educational CD-ROM to see how well it     works compared with standard informed consent to assist decision-making about MSI testing in     patients with colorectal cancer or a family history of colorectal cancer.   "
199402|NCT00450437|"     This study will evaluate the lot to lot consistency, safety and immune response of the     Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.   "
199403|NCT00450450|"     This randomized phase III trial is studying donor bone marrow transplant with or without     G-CSF to compare how well they work in treating young patients with hematologic cancer or     other diseases. Giving chemotherapy and total-body irradiation before a donor bone marrow     transplant helps stop the growth of cancer or abnormal cells. It also helps stop the     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells     from a donor are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells     from a donor can make an immune response against the body's normal cells. Giving methotrexate     and tacrolimus or cyclosporine before and after transplant may stop this from happening. It     is not yet known whether donor bone marrow transplant is more effective with or without G-CSF     in treating hematologic cancer or other diseases.   "
199453|NCT00451100|"     The purpose of this study was to demonstrate in adult patients a faster recovery from a     neuromuscular block with 2.0 mg/kg Org 25969 (sugammadex) after rocuronium as compared to 50     ug/kg neostigmine after cisatracurium when administered at reappearance of T2   "
199404|NCT00450463|"     Background:        -  Flutamide is an approved drug for prostate cancer that blocks the effects of          testosterone on prostate cancer cells and may slow the progression of the disease.        -  The vaccine in this study consists of a priming vaccine called PROSTVAC-V/TRICOM, made          from vaccinia virus, and a boosting vaccine called PROSTVAC-F/TRICOM, made from fowlpox          virus. DNA is inserted into the priming and boosting vaccine viruses to cause production          of proteins that enhance immune activity and also to produce prostate specific antigen          (PSA) a protein that is normally produced by the patient s tumor cells.        -  GM-CSF, given along with the vaccine, is a chemical that boosts the immune system. It is          used in this study to try to increase the usefulness of the vaccine by increasing the          number of immune cells at the vaccination site.      Objectives:      -To determine if treatment with a prostate cancer vaccine plus flutamide is more effective     than flutamide alone in delaying disease progression in patients with prostate cancer.      Eligibility:        -  Patients 18 years of age and older with androgen-insensitive prostate cancer that has          not spread beyond the prostate gland.        -  Patients with a rising PSA who have already been treated with anti-iandrogen therapy          (either bicalutamide or nilutamide).      Design:        -  There are two treatment groups in this study. Group A receives only flutamide; group B          receive flutamide plus vaccine.        -  Patients in both groups receive flutamide by mouth three times a day.        -  Patients in group B receive PROSTVAC-V/TRICOM on day 1 and PROSTVAC-F/TRICOM on day 29          and again every 4 weeks. All vaccines are given as injections under the skin.        -  Patients have blood tests for PSA levels every month and scans every 3 months until the          disease worsens.        -  After 3 months of therapy, patients receiving in group A (flutamide alone) may cross          over to receive vaccine if they develop a rising PSA and scans show no sign of disease          spread. Patients in group B (flutamide plus vaccine) stop flutamide and may continue          vaccine therapy. At this point patients may continue to receive treatment until the          disease progresses or PSA levels rise....   "
199405|NCT00450476|"     To evaluate the correlation between endotracheal tube size and incidence of dysfunction of     suction lumen of Hi-Lo Evac endotracheal tube in critically ill patients who required     mechanical ventilation for more than 48 hours.   "
199406|NCT00450489|"     The purpose of this study is to evaluate the change score for the PedsQL short form Diabetes     and Core Modules and the Patient Assessment of Chronic Illness Care measured at baseline     (before changing care delivery models) and 12 months after transitioning to the team model of     care delivery.   "
199407|NCT00450502|"     Background:        -  Batracylin advanced through the National Cancer Institute (NCI) drug development          pipeline until its evaluation at Stage 3 on July 1989, It was then proposed for a phase          I investigation based on its activity against as TOPO II inhibitor in s.c. mouse colon          38, PANC03, COLO9, and cisplatin- and doxorubicin-resistant P388 tumors.        -  IND-directed oral toxicology studies indicated interspecies variation in toxicity. Rats          were found to be highly sensitive to batracylin. Ames et al showed that the interspecies          variation in toxicity was consistent with the pattern of metabolism of the compound by          N-acetyltransferase 2 (NAT2) to the acetylated form, N-Ac-batracylin, (a highly toxic          molecule)        -  We hypothesize that batracylin can be administered safely in slow acetylator NAT2          genotype patients and can be rapidly evaluated for its potential as a tumor-suppressing          agent.      Objectives:        -  Define the maximum tolerated dose, dose-limiting toxicities, and toxicity profile          associated with the oral administration of batracylin daily x7 consecutive days,          repeated every 28 days in patients with solid tumors and lymphomas.        -  Define the pharmacokinetics of oral batracylin administered daily x7 consecutive days          every 28 days.        -  Obtain preliminary evidence of anti-tumor activity of batracylin in patients with solid          tumors or lymphoma.        -  Correlate polymorphisms in slow acetylators NAT2 genotypes (NAT2 5, NAT2 6, NAT2 7, and          NAT2 14) with pharmacokinetics results.        -  Evaluate the inter-subject variability and toxicity ratio, (N-Ac-Batra) / (batracylin).        -  Evaluate the effect of batracylin treatment on gamma-H2AX levels in tumor biopsies.      Eligibility:        -  Patients must have a slow acetylator NAT2 genotype defined as NAT2 5, NAT2 6, NAT2 7, or          NAT2 14.        -  Patients with advanced, histologically confirmed malignancies refractory to standard          therapy, or those for whom no standard therapy exists.        -  Patients should have adequate liver, renal, and bone marrow function.      Study Design:        -  In accordance with the accelerated titration design 4B[3], dose levels will initially be          increased at 100% increments, and one new patient per dose level will be treated          according to a 4-week course.        -  The accelerated phase ends when one patient experiences dose limiting toxicity (DLT)          during the first course of treatment, or when two different patients experience grade 2,          batracylin-related toxicity during the first course of treatment, or when the          N-acetyl-batra AUC value reach 0.33 uM-Hour (i.e., the lower end of the range in the          rat).        -  When the first instance of grade 2 batracylin-related toxicity is observed, two          additional patients must have been treated at that dose, or a higher dose (during any          course), without experiencing moderate (grade 2) or worse (grade 3) toxicity, in order          for the accelerated phase to continue.        -  When the accelerated phase ends, the dose-escalation will revert to a more conservative,          modified Fibonacci scheme with 40% dose-step increments, with at least 3 patients          treated per dose level.   "
199408|NCT00450515|"     RATIONALE: Drugs used in chemotherapy, such as vinflunine and capecitabine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving vinflunine together with     capecitabine works in treating patients with previously treated metastatic breast cancer.   "
199409|NCT00450528|"     The purpose of this study is to investigate the natural kinetics of D-dimers that occur after     abdominal surgery.   "
199410|NCT00450541|"     The goal of this research study is to learn what it is like when a patient with cancer has     fatigue, as well as how these patients define fatigue. Researchers want to use this     information to create questionnaires that may more accurately measure fatigue and its effects     in patients with cancer.   "
199411|NCT00450554|"     The main objective of the study is to estimate the proportion of children, born between the     01/01/2002 and the 06/23/200, living around Dieppe (cantons Dieppe est, Dieppe Ouest and     Offranville), vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16     clone related to a protection (>= 4), before and after the third MenBvac vaccination.   "
199412|NCT00450567|"     RATIONALE: Measuring changes in glucose metabolism in patients with cancer may help doctors     predict how patients respond to treatment.      PURPOSE: This clinical trial is studying glucose metabolism in patients with non-small cell     lung cancer treated with targeted therapy and chemotherapy.   "
199413|NCT00450580|"     This is a Phase IIIB, 48 Week, multicentre, randomized, open-label, parallel group study     comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg/100mg once-daily to     fosamprenavir plus ritonavir 700mg/100mg twice-daily, both administered with     abacavir/lamivudine 600mg/300mg once-daily in antiretroviral-naive HIV-1 infected adults.     This study utilizes a group-sequential design with two stages: 1) an interim 24 week cohort     analysis of approximately 200 subjects and 2) if study continuation criteria are met at this     interim analysis, further enrolment of an additional 528 subjects, followed over a minimum of     48 weeks. The objectives of the study are to demonstrate 1) non-inferior antiviral activity     of fosamprenavir/ritonavir 1400mg/100mg QD compared to fosamprenavir/ritonavir 700mg/100mg     BID and 2) a superior fasting non-HDL lipid profile in subjects receiving     fosamprenavir/ritonavir 1400mg/100mg QD.   "
199414|NCT00450593|"     RATIONALE: Identifying gene mutations and other risk factors in patients with melanoma and in     families with a history of hereditary melanoma may help doctors identify persons at risk for     melanoma and other types of cancer. It may also help the study of cancer in the future.      PURPOSE: This clinical trial is studying gene mutations in patients with melanoma and in     families with a history of hereditary melanoma.   "
199415|NCT00450606|"     This study will check the efficacy of balneological therapy of bathing in Dead Sea fountain     waters over a 6 week period on a twice a week basis (overall 12 treatments) in patients     suffering from osteoarthritis of the knees.   "
199625|NCT00459654|"     The purpose of this study is to evaluate the effectiveness of the investigational     radioisotope Radium-223 in treatment of men with prostate cancer and bone metastases that no     longer respond to hormonal treatment.   "
199416|NCT00450619|"     Background:        -  No treatment is known to improve survival for prostate cancer patients who have not been          helped by previous treatments with hormones and chemotherapy.        -  An experimental vaccine called prostate specific antigen (PSA)/TRICOM contains genes for          a protein produced by prostate cancer cells called prostate-specific antigen (PSA). The          vaccine can trigger the immune system to make cells that may be able to recognize and          attack the cancer cells that make PSA.        -  Granulocyte macrophage colony stimulating factor (GM-CSF) is an approved drug that is          usually given to increase a patient's white blood cell count or to stimulate the immune          system.        -  1Samarium-153-ethylene diamine tetramethylene phosphonate (53Sm-EDTMP) is a radioactive          drug that has been approved for many years to treat advanced prostate cancer. It is          given through a vein and can be targeted directly to tumors in the bone where it can          relieve pain caused by bone lesions. Radiation also increases the level of certain          proteins inside the tumor, making it easier for the immune system to find and kill the          tumor cells.        -  When laboratory mice were given just vaccine, just radiation, or a combination of both,          the combination was most effective in treating tumors.      Objectives:      -To determine if combined treatment with PSA/TRICOM vaccine and 153Sm-EDTMP radiation can     delay progression of prostate cancer better than radiation alone.      Eligibility:      -Patients who have advanced prostate cancer that has worsened despite treatments with     hormones, have two or more bone lesions related to their prostate cancer, and have had prior     treatment with docetaxel chemotherapy.      Design:        -  Patients are randomly assigned to receive radiation alone (Arm A) or radiation with          vaccine and sargramostim (Arm B).        -  Arm A receives 153Sm-EDTMP radiation starting on study day 8 and repeated every 12          weeks.        -  Arm B receives a priming vaccine on study day 1 and radiation on day 8. Radiation          therapy is repeated every 12 weeks. Boosting vaccines are given on days 15 and 29 and          then monthly. GM-CSF is given with each vaccination (on the day of the vaccination and          for the next 3 days) to enhance the immune response. Vaccinations and GM-CSF are given          as injections under the skin, usually in the thigh. Radiation therapy is given through a          vein.        -  Patients are monitored regularly with physical examinations, blood and urine tests, and          scans to evaluate safety and treatment response.        -  Patients who are human leukocyte antigen serotype within HLA-A A serotype group          (HLA-A2)-positive undergo apheresis, a procedure similar to donating blood, for          obtaining immune cells called lymphocytes to measure the immune response to the vaccine.   "
199417|NCT00450632|"     The main objective of this study is to constitute a biotheque of patients with meningococcal     disease to enable results to be interpreted and genetic factors to be determined   "
199418|NCT00450645|"     The duration of anticoagulant treatment in cancer patients with Deep Vein Thrombosis (DVT) of     the lower limbs is still uncertain. The present study addresses the possible role of the     Residual Vein Thrombosis (RVT) for establishing the optimal duration of Low Molecular Weight     Heparin (LMWH). Patients with a first episode of symptomatic unprovoked or provoked proximal     DVT will received LMWHs for 6 months; RVT, ultrasonographically-detected, will be then     assessed. Patients without RVT stop LMWH, whereas those with RVT will be randomized to either     stop or continue OAT for additional 6 months. Patients were followed-up at least 1 year after     anticoagulant discontinuation focusing on the study outcomes: occurrence of recurrent venous     thromboembolism and major bleeding   "
199419|NCT00450658|"     The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of     development of ibuprofen-associated ulcers in patients who require long-term daily use of     ibuprofen.   "
199420|NCT00450671|"     The purpose of this study is to determine if the collagen plug method heals perirectal     fistulae as well as the conventional seton method.   "
199421|NCT00450684|"     The objective of this multicentre prospective therapeutic study is to evaluate the effects of     CRT on the right and left ventricular function of patients with CHD in the medium and long     term. Patients who reject the randomization or cannot be paced with right ventricular pacing     alone will be enrolled in group C with continuous biventricular pacing, which is the main     group in this study. Optional: Immediately after implantation the patients are divided into     group A and B (randomized, single blind (for the patient), cross-over design).      The treatment and the completing follow-up examination will take approximately 18 months and     includes seven visits - one previous to the CRT and six at certain times afterward. At     selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the     global and regional ventricular function are performed. Subjective quality of life assessment     (questionnaire) will also be performed at the defined follow-up intervals, and if applicable     (optional) also objective assessment of the physical performance (VO2 max).      55 patients also including children and adults with CHD are planned to be included in the     study. The main target is to provide evidence of the effectiveness of CRT with biventricular     stimulation in terms of improved ventricular function (ejection fraction and QRS interval).   "
199422|NCT00450697|"     Premature infants, especially those less than 1250 gm at birth are extremely difficult to     feed. For unknown physiologic reasons oral feeding also called enteral feeding is not well     tolerated in these immature babies. Because of this challenge these infants require     intravenous fluids solution called parenteral nutrition (TPN). Intravenous nutrition is     inadequate because it cannot supply sufficient calories for growth both of body and brain.     The composition of intravenous nutrition is also toxic to the liver.      For those reasons it is very important to achieve adequate enteral nutrition in premature     infants as soon as possible after birth. However the best feeding method for those babies has     not been defined.      Since premature babies are unable to suck and swallow properly, feeding is administered by a     tube inserted into the infant's stomach. The timing between feeds is inconsistent. Some     infants are fed every 3 hours, whereas others are fed every 4 hours.      The purpose of this study is to determine which feeding method is better. We hypothesize that     feeding every 4 hours by allowing more time for digestion will improve feeding tolerance in     premature infants. In addition it will also facilitate discontinuation of TPN sooner, thus     causing less side effects.   "
199423|NCT00450710|"     Evaluation to determine the safety of two laparoscopic procedures to control T2DM.   "
199424|NCT00450723|"     RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help     find breast cancer that has spread to lymph nodes between the breasts. It may also help     doctors plan the best treatment.      PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy     finds sentinel lymph nodes that are located between the breasts in patients with stage I or     stage II breast cancer.   "
199425|NCT00450736|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving celecoxib together with radiation therapy     after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when     given together with radiation therapy in treating patients with stage II or stage III soft     tissue sarcoma of the arm, hand, leg, or foot that has been removed by surgery.   "
199426|NCT00450749|"     This randomized phase II trial studies how well different doses of lycopene work in treating     patients undergoing radical prostatectomy for prostate cancer. The use of lycopene, a     substance found in tomatoes, may keep prostate cancer from growing or coming back after     surgery.   "
199427|NCT00450762|"     The rational for this trial is given by the knowledge that gemcitabine acts as a potent     inhibitor of DNA repair and therefore may prevent adequate repair of platin-induced DNA     damage. Gemcitabine is an excellent choice for combination therapy by its unique mechanism of     action and favourable toxicity profile. The combination of gemcitabine and cisplatin was     shown to be effective in several trials, producing response rates of 30-52 % in patients with     pretreated metastatic breast cancer. To improve on tolerability and handling of the regime     carboplatin may be the more appropriate choice for treatment. The mechanism of action of     carboplatin is very similar to that of cisplatin. The rational for combining gemcitabine and     carboplatin is based on their single-agent activities in metastatic breast cancer, the     activity of this combination in other malignancies and on the fact that carboplatin has     demonstrated efficacy comparable with cisplatin in several tumor types.   "
199428|NCT00450775|"     The purpose of this study is to evaluate the efficacy and patient acceptance of Dermatix Q     for the prevention and treatment of scarring.   "
199429|NCT00450788|"     Background:      -Esophageal cancer is the most common cancer in Iran s Golestan Province. Nutritional     deficiencies, ethnicity and environmental exposures might contribute to the development of     this disease.      Objectives:      -To better understand the cause of esophageal cancer in Golestan Province and to reduce its     occurrence there.      Eligibility:      -Adults from the Gonbad, Aq-Qala and Kalaleh districts of eastern Golestan Province in Iran.      Design:        -  The study is a collaboration between NIH, the Digestive Disease Research Center of          Teheran University of Medical Sciences, and the International Agency for Research on          Cancer.        -  Participants complete a lifestyle questionnaire and food frequency questionnaire.        -  Samples of participants blood, urine, hair and toenail clippings are obtained.   "
199430|NCT00450801|"     RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with     thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma      PURPOSE: This phase II trial is studying how well giving rituximab together with combination     chemotherapy followed by thalidomide works in treating patients with previously untreated     mantle cell lymphoma.   "
199431|NCT00450814|"     This phase I/II trial studies the side effects and best dose of vaccine therapy when given     with or without cyclophosphamide and to see how well they work in treating patients with     multiple myeloma that has come back (recurrent) or has not responded to previous treatment     (refractory). Vaccines made from a gene-modified virus may help the body build an effective     immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide,     work in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Giving vaccine therapy     together with cyclophosphamide may be a better treatment for multiple myeloma.   "
199432|NCT00450827|"     RATIONALE: Monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8 and     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Bevacizumab may also stop the growth of neuroblastoma by blocking blood     flow to the tumor. Giving iodine I 131 monoclonal antibody 3F8 together with bevacizumab may     kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131     monoclonal antibody 3F8 when given together with bevacizumab in treating patients with     relapsed or refractory neuroblastoma.   "
199433|NCT00450840|"     The beneficial effect of statins to prevent cardiovascular events in patients at risk is well     established. Recent trials demonstrated that statins can exert a number of vascular actions     independent of lipid lowering. Short-term simvastatin therapy recently has been reported to     reduce mortality in 2 different animal models of sepsis. Pleiner and coworkers could     demonstrate potent vasoprotective properties of simvastatin during Escherichia coli endotoxin     induced endotoxemia in healthy volunteers. In a population-based cohort analysis it was     demonstrated that administration of statins was associated with a reduced risk of subsequent     sepsis. Thus, simvastatin treatment may offer a new therapeutic strategy for clinical     conditions associated with inflammation like severe sepsis and septic shock. The aim of the     present study is to test the hypothesis that short term treatment with simvastatin may     mitigate the detrimental vascular effects of acute inflammation in patients admitted to the     intensive care unit requiring treatment for septic shock.   "
199434|NCT00450853|"     Objective: to evaluate the bioavailability of subcutaneous granisetron.Patients receiving     platinum-based chemotherapy will be randomized to receive granisetron 3 mg either     subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine     samples will be collected after each cycle.   "
199435|NCT00450866|"     RATIONALE: Drugs used in chemotherapy, such as epothilone B, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well epothilone B works in treating patients     with CNS metastases from breast cancer.   "
199436|NCT00450879|"     This pilot clinical trial studies how well pazopanib hydrochloride works in treating patients     with breast cancer that is newly diagnosed or has come back at or near the same place as the     original tumor and can be removed by surgery. Pazopanib hydrochloride may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth and by preventing the     growth of new blood vessels necessary for tumor growth. Giving pazopanib hydrochloride before     surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed.   "
199437|NCT00450892|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Giving these treatments before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery     may kill any tumor cells that remain after surgery.      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of     docetaxel and lapatinib when given with or without combination chemotherapy and to see how     well they work in treating women with locally advanced, inflammatory, or resectable breast     cancer.   "
199439|NCT00450918|"     Mucociliary clearance, in which mucus secretions are cleared from the breathing airways, is     the primary defense mechanism for the lungs. Inhaled particles, including microbes that can     cause infections, are normally entrapped in mucus on the airway surfaces and then cleared out     by the coordinated action of tiny hair-like structures called cilia. Individuals with primary     ciliary dyskinesia (PCD) have defective mucociliary clearance, which in turn leads to lung     infections and disease. The purpose of this study is to determine how lung disease progresses     over time in children and adolescents with PCD.   "
199440|NCT00450931|"     RATIONALE: The way in which information about a drug is provided may affect the ability of     patients and doctors to understand how a drug works and the side effects of the drug.      PURPOSE: This randomized trial is studying how well a drug facts page works compared with a     standard brief summary in helping patients and doctors understand medical information.   "
199441|NCT00450944|"     RATIONALE: Immunotoxins, such as anti-CD19 and anti-CD22, can find cancer cells that express     CD19 and CD22 and kill them without harming normal cells. This may be an effective treatment     for B-cell acute lymphoblastic leukemia.      PURPOSE: This phase I trial is studying the side effects and best dose of anti-CD19 and     anti-CD22 immunotoxins in treating patients with refractory or relapsed B-cell acute     lymphoblastic leukemia.   "
199442|NCT00450957|"     This randomized phase I trial is studying the side effects and best dose of lycopene in     healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from     forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.   "
199443|NCT00450970|"     The SPERA trial is designed to 1. provide satraplatin to physicians with patients who have     hormone refractory prostate cancer (HRPC) which has progressed following unlimited cytotoxic     chemotherapy regimens for metastatic disease and 2. to evaluate the safety of oral     satraplatin in this patient population.   "
199444|NCT00450983|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood     stem cell and donor natural killer cell transplant helps stop the growth of cancer and     abnormal cells and helps stop the patient's immune system from rejecting the donor's stem     cells. When certain stem cells from a donor are infused into the patient they may help the     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Sometimes the transplanted cells from a donor can make an immune response against the body's     normal cells. Removing the T cells from the donor cells before transplant may stop this from     happening.      PURPOSE: This phase II trial is studying how well giving a donor peripheral stem cell     transplant and a donor natural killer cell transplant after total-body irradiation, thiotepa,     fludarabine, and muromonab-CD3 works in treating patients with leukemia or other blood     diseases.   "
199445|NCT00450996|"     PURPOSE: To assess the impact of duration of topical steroid treatment on the incidence of     endothelial graft rejection following normal-risk penetrating keratoplasty (PK). DESIGN:     Prospective, institutional, longitudinal, randomized interventional trial including 406 eyes     (age: 52 >= 19 years; follow-up: 42 >= 18months). METHODS: Postoperative treatment started     with prednisolone acetate 1% eye drops five times daily and was tapered over the first 6     months. Patients were then randomised into either short-term (stop topical steroid treatment)     or long-term treatment (continue steroids once daily until 12 months).   "
199446|NCT00451009|"     The purpose of this study is to determine the effectiveness of the ViaCell's product media     for freezing and thawing human eggs for future use in assisted reproductive technology.   "
199447|NCT00451022|"     This study aims to provide long-term follow-up care of patients previously enrolled in a     vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that     can be used to introduce specific genes into genetic makeup. The study does not involve the     use of any drug or biologic agent. Participants will undergo an annual health history.     Because certain viruses enter into cells and create proteins from the viral genes, the type     of vaccine treatment used is referred to gene therapy. The genes expressed by poxviral     vectors do not become part of the genetic material left behind. Because gene therapy is a     somewhat new technology, a prolonged monitoring of patients' health status is necessary,     according to new specific reporting requirements for harmful events in patients who undergo     such gene therapy studies. The risk of any long-term negative effects from the gene therapy     that patients had received is quite small. Still, it is important that there be updates at     least annually. This annual monitoring of health status will extend for 15 years, according     to guidelines from the Food and Drug Administration, or for as long as patients are willing     to participate.      Patients who received poxviral vectors (vaccinia or fowlpox, or both) at the National Cancer     Institute, through a trial affiliated with the Laboratory of Tumor Immunology and Biology,     may be eligible for this study.      Participants will be involved in the following forms of data collection:        -  Annual medical history and physical examinations for the first 5 years following the          last vaccine.        -  Annual telephone contact during the last 10 years.        -  Health status check, including primary cancer status, secondary malignancies, neurologic          disorders, autoimmune disorders, and hematologic disorders.        -  Blood tests for the presence of HIV antibodies.        -  Reporting of medical problems, including information on unexpected hospitalizations and          medications.      If a participant has died, the study will document the cause of death and autopsy information     if available.   "
199448|NCT00451035|"     This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic     phase chronic myeloid leukemia with resistant disease following treatment with at least two     BCR-ABL tyrosine kinase inhibitors   "
199449|NCT00451048|"     This phase II trial is studying how well sunitinib works in treating patients with     myelodysplastic syndromes or chronic myelomonocytic leukemia. Sunitinib may stop the growth     of abnormal cells by blocking some of the enzymes needed for cell growth.   "
199450|NCT00451061|"     Most of the patients suffering from renal colic have a distal ureterolithiasis. It had been     demonstrated that α adrenoreceptors antagonists, given to patients suffering from renal     colic, due to distal ureterolithiasis, had increased the frequency of stone expulsion rate ,     reduced the time to expulsion and reduced analgesics consumption.Most of the studies     evaluated the efficacy of Tamsulosin, which is a selective α 1A and α 1D adrenoreceptors     antagonist.(The lower intramural portion of the ureter, where it passes through the detrusor     muscle contains mostly α 1D and α 1A adrenergic receptors)      Only one study these days describes the use of Alfuzosin, which is an α adrenergic receptor     blocker and not selective for any α 1 adrenergic receptor, for expulsion of distal ureteric     stones.Alfuzosin is a drug with a proven efficacy and considered uroselective with high     specificity and sensitivity, for the treatment of BPH. There was no significant difference in     efficacy between the two α blockers (Alfuzosin vs. Tamsulosin) concerning symptoms relief or     flow improvement.      The objective of this study is to compare patient who would receive the standard treatment     for distal ureterolithiasis (analgesics, Rowatinex) to patients who would receive also a non     selective α blocker (Alfuzosin) or a selective α blocker (Tamsulosin). This in order to     evaluate the efficacy of treatment with α blockers for expulsion of distal ureterolithiasis.   "
199454|NCT00451113|"     Diabetes is common in the elderly; by the age of 70, approximately 25% of the population will     have diabetes. Unfortunately, currently available medications are often not as effective or     not well tolerated in older adults. Sitagliptin is a new medication in a new class of agent     called incretins. Incretins have many potential advantages for the treatment of diabetes in     the elderly. They stimulate insulin secretion, which is impaired in all older people with     diabetes. The incidence of hypoglycemia with currently available medications increases with     age, and incretins rarely cause hypoglycemia . They assist with weight loss, whereas many     current medications used to manage diabetes result in weight gain in the elderly. They     improve insulin action, and insulin resistance is a major problem in older people with     diabetes.   "
199455|NCT00451126|"     With the aim of evaluating the putative impacts of emotion related personality factors on     physical and mental disease and the mechanisms of these impacts, 58 students were submitted     to a social stress test (Trier Social Stress Test) and salivary cortisol samples were taken.     The subjects were also submitted to several personality trait inventory, that evaluated     respectively Alexithymia, Emotional Intelligence, Resilience and the Five Factor Model of     Personality.      The moderating impact of these factors on the cortisol response were analysed   "
199456|NCT00451139|"     The purpose of the study is to evaluate the potential side-effects of artemether /     lumefantrine and other antimalarials on the auditory function.   "
199457|NCT00451152|"     The purpose of this study was to evaluate the safety and intraocular pressure (IOP)-lowering     efficacy of anecortave acetate for treatment of elevated IOP in patients with open-angle     glaucoma.   "
199458|NCT00451165|"     Research Populations: Male patients scheduled for laparoscopic colorectal surgery      Study Method: Questionnaire and function tests      Hypothesis: A laparoscopic nerve-sparing operation is not inferior to reported open surgery     in preserving urinary and sexual function.   "
199459|NCT00451178|"     To compare R-CHOP plus enzastaurin versus R-CHOP for progression-free survival (PFS) time     measured in patients with intermediate and/or high risk DLBCL receiving first-line treatment.   "
199460|NCT00451191|"     This is a double-blind randomized phase II trial to determine whether two different doses of     BoNT/A injection into the prostate gland demonstrate sufficient improvement in the management     of lower urinary symptoms due to BPH to warrant more extensive research. Subjects will     receive either a 100U or 300U dose. Participation will last 1 year.   "
199461|NCT00451204|"     This is a double-blinded, placebo controlled study of estriol pills versus placebo pills in     relapsing remitting multiple sclerosis. The study treatment will be an added on to Copaxone     injections in all subjects. The primary outcome measure is a reduction in relapses.   "
199462|NCT00451217|"     The purpose of this study was to demonstrate in adult patients faster recovery from a     neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance     of T2 by 2.0 mg/kg Org 25969 (sugammadex) compared to 50 ug/kg neostigmine.   "
199463|NCT00451230|"     The goal of this this study is to elucidate the role of the HPA axis in the pathophysiology     of cocaine dependence   "
199464|NCT00451243|"     Psoriasis is a multifactorial cutaneous disorders which affects about 100000 patients in     Taiwan. Psoriatic arthritis is also present in about 20~30 percents. Many drugs have been     shown to aggravate psoriasis including drugs used in the treatment of psoriatic arthritis. On     the contrary, anti-psoriatic drugs are also known to aggravate or induce psoriatic arthritis.     Psoriasis and psoriatic arthritis are believed to share the same pathogenic lymphocytes, but     the differential responses to drugs are intriguing. This also causes problems in the     treatment of psoriasis and psoriatic arthritis. Recently different serologic markers have     been found for the assessment of psoriasis and psoriatic arthritis. Recent genetic study     showed a different genetic susceptibility genes. We tested the serologic responses of three     new biologic drugs used in the treatment of psoriasis and psoriatic arthritis. Paired blood     samples of the same patients before and after 12 weeks of treatment were used. IL6 decreased     after alefacept and etanercept but was increased after efalizumab treatment without     statistical significance (Paired t test: 0.3336、0.2773、0.5904)。IL-8 decreased after     etanercept but increased after efalizumab and alefacept without statistical significance     (Paired t test: 0.4031、0.6749、0.2998)。IL10 decreased after efalizumab and etanercept, but     increased significantly after alefacept treatment (Paired t test: 0.7254、0.5123、0.0350)。None     of the treatment has a significant effect on TNF-alpha. HC10 decreased after alefacept and     efalizumab,but increased after etanercept treatmentwithout statistical significance (Paired t     test: 0.6589、0.1576、0.1988).   "
199465|NCT00451256|"     For some people who have heart by-pass surgery, the vein that is used to by-pass a blockage     will, after some time, become narrowed and possibly blocked. AVI-5126 blocks a gene that is     believed to be responsible for the events in the blood vessel that cause this narrowing.     Therefore, exposing the vein to AVI-5126 before it is attached to the coronary artery may     result in less problems with these vein grafts later on. This study will determine if this     procedure is both safe and effective.   "
199466|NCT00451269|"     The annual number of cases of clinical malaria worldwide is estimated to be 300-500 million     leading to 1.5 million deaths. Delayed care and frequent drug resistance of Plasmodium     falciparum (Pf), the most frequent form of malaria, is responsible for these deaths. Each     year, 5000-8000 travellers return to France with malaria, 4/5 from Africa and with Pf.     Clinical features associated with a malaria crisis are poorly predictive and misdiagnosis can     be easily made. Diagnosis of accurate malaria rely on microscopic examination of stained thin     and thick blood films by a well trained microscopist. Few emergency wards are specialized for     tropical diseases. For most of them, malaria is a rare disease and hours are lost before     accurate microscopy can permit the decision   "
199480|NCT00451451|"     To determine if treatment with BG00012 can decrease the number of MS relapses during a     certain time period. Other goals of the study are to determine if, over time, BG00012     treatment can decrease the number of certain types of brain lesions commonly seen in MS     patients and slow down the time it takes for MS to get worse.      Other objectives of the study are to determine the safety and tolerability of BG00012, as     well as the effect it may have on tests and evaluations used to assess MS. Additionally,     glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.   "
199467|NCT00451282|"     This study will evaluate the impact of a brief psychosocial intervention delivered to     children or adolescents who are hospitalized for an unintentional injury. The intervention is     designed to promote psychological recovery and enhance functional outcomes after injury. The     study will also provide preliminary data concerning cost-effectiveness of the intervention.      The core study hypotheses are that children receiving the intervention will (1) have lower     severity of post-traumatic stress disorder (PTSD) and depression symptoms at follow-up; (2)     show greater adherence to discharge instructions and better health-related quality of life at     follow-up, and (3) have higher rates of attendance at scheduled follow-up appointments and     lower rates of emergency room utilization and re-hospitalization in the 6 months post-injury,     compared to those receiving usual care.   "
199468|NCT00451295|"     This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks     treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the     treatment period, MCI-196 or placebo will be titrated every 3 weeks.   "
199469|NCT00451308|"     The rate of labor induction is rising throughout the United States for a variety of reasons.     Medical conditions that lead to increased risk of prolonging the pregnancy to both mother and     fetus are not infrequent. In addition, elective deliveries are becoming more common. Foley     balloon catheter placement is a common method used for labor induction in women with an     unfavorable cervical assessment. There are several studies using various volumes of Foley     balloon catheters for labor induction ranging from 30ml to 80ml, however, there are no     studies replicating the findings of the largest study comparing 2 different volumes in the     balloon. The investigators plan to compare instillation of 30ml of sterile saline versus 60ml     in a Foley balloon catheter for women undergoing induction of labor with an unfavorable     cervix. The investigators will observe the following outcomes: rate of delivery within 24     hours, cervical dilation after foley balloon catheter expulsion, insertion to balloon     expulsion interval, induction to delivery time interval, peak oxytocin requirement, presence     of infection or meconium, cesarean delivery rate, operative vaginal delivery rate, indication     for operative vaginal or cesarean delivery, cervical laceration rate, placental abruption     rate, 5-minute Apgar score, and umbilical cord arterial blood pH and base excess.   "
199470|NCT00451321|"     The purpose of this study is to optimize several multi-dose regimens of otelixizumab,     determine the highest biologically active dose, evaluate biomarkers and surrogates of     efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against     standard safety and efficacy parameters.   "
199471|NCT00451334|"     This study is a prospective, open label, controlled, single center study. 40 patients will be     recruited for the study, according to patients’ inflow and meeting eligibility criteria.      Primary Goal      * To evaluate the safety of the GlucoSat technology as a non-invasive blood glucose level     measurement technology.      Secondary Goal      * To assess the efficacy of the GlucoSat technology as a non-invasive blood glucose level     measurement technology.   "
199472|NCT00451347|"     Objectives:The purpose of this study was to investigate the different effects among the     quadriceps strength training, taping, and stretching exercise of iliotibial band in patients     with patellofemoral pain syndrome by randomized control trial study.      Method:An observer blind, prospective, factorial design randomized controlled trail. 90 young     adults with patellofemoral pain syndrome were randomly allocated into one of three treatment     groups: (1) Quadriceps strength training, (2) taping, and (3) stretch. Each group received     treatment for 8 weeks.      Hypothesis:Patients in quadriceps strength training group may get most outcomes in three     groups   "
199473|NCT00451360|"     We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical     trial in patients with hip osteoarthritis in order to:        -  evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive          decrease in joint space width observed in patients with hip osteoarthritis        -  to investigate the potential structure-modifying effect of diacerein in patients with          hip osteoarthritis      This study compare also after ten years the percentage of patients in each treatment group     who require a hip replacement surgery   "
199474|NCT00451373|"     We examine the prognosis and etiology of postoperative acute renal failure   "
199475|NCT00451386|"     This study will investigate the safety and efficacy of ertapenem versus ceftriaxone in     pediatric patients with urinary tract infections, skin infections, or community-acquired     pneumonia.   "
199476|NCT00451399|"     Lifestyle intervention and certain medications have been shown to be effective for     antipsychotic-induced weight gain, but no controlled studies have compared psychological and     pharmacological therapies. We conducted a randomized, placebo-controlled study to test the     efficacy of lifestyle intervention and metformin alone and in combination for     antipsychotic-induced weight gain.   "
199477|NCT00451412|"     This study is designed to provide efficacy and safety data for certoparin in the prophylaxis     of venous thromboembolism in immobilized, acutely ill medical patients.   "
199478|NCT00451425|"     Excessive weight gain during pregnancy is associated with complications during delivery     primarily due to macrosomia (large babies) but also with high levels of weight retention post     pregnancy and thereby increased risk of future weight related health problems. The primary     aim of this study is to evaluate the efficacy of an intervention consisting of; recurrent     Motivational Interviewing (MI), prescription of physical activity and extended information on     recommended weight gain during pregnancy in regards to preventing excessive gestational     weight gain.   "
199479|NCT00451438|"     The purpose of this study is to investigate the muscle activity of gluteus medius and tensor     fascia lata in health control group and patients with PFPS during submaximal isometric muscle     contraction.The research question :Is there any difference of muscle activity of gluteus     medius and tensor fascia lata between health control group and patients with PFPS during     submaximal isometric muscle contraction ？Null hypothesis:There is no difference of muscle     activity of gluteus medius and tensor fascia lata between health control group and patients     with PFPS during submaximal isometric muscle contraction.   "
199512|NCT00451893|"     The trial compares the postoperative complain, pain, quality of life after the implantation     of a heavy-weight alternative light-weight mesh, by randomly allocating patients with     inguinal hernia disease to two groups of surgeons, each group being trained to operate with     one of the above mentioned meshes.      Hypothesis: There is less postoperative pain after the implantation of a light-weight mesh.   "
199481|NCT00451464|"     Cardiovascular-related diseases have been the majorities of the leading ten causes of death     in Taiwan. Atherosclerotic cardiovascular diseases are multifactorial. Some non-modifiable     risk factors (e.g. genetic trait) may attenuate the benefit of risk modification of the     modifiable factors (e.g. the effect of drug treatment). Genetic epidemiology has being widely     used to analyze the underline risk of cardiovascular diseases and to point the direction of     treatment or prevention.      Lipoprotein is composed of lipid and protein. The genetic variation or mutation of     apolipoprotein, the protein of lipoprotein, has been linked to some lipid abnormality     resulting severe atherosclerotic cardiovascular diseases. ApoA-I, apo A-II, apo A-IV, apo     B100, apo B48, apo C-I, apo C-II, apo C-III, apo D, and apo E are currently thought to affect     lipid abnormalities. In addition, it has been documented that genetic variations are     presented among different races. Apolipoprotein genetic variations or genetic polymorphism     study has been emerged as an important role in the field of genetic therapy. The purpose of     this 3-year study is to continue the lipid study in our laboratory, identifying the     apolipoprotein genotyping in our pooled hyperlipidemic patients and normal control subjects     living in Taiwan. We will observe the incidence and link apo A-I, apo A-II, apo A-IV and apo     C-III genetic variations to the related lipid abnormality and cardiovascular diseases. The     changes of genotyping after lipid lowering drug treatment using statin or fibrate in     hypercholesterolemic or hypertriglyceridemic patients is another goal of this project.   "
199482|NCT00451490|"     Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both     agomelatine and floxentine will increase HRV at the end of the treatment.   "
199483|NCT00451503|"     The middle ear implant are used for patients with mild to severe sensorineural hearing loss,     who cannot benefit from conventional hearing aids because of medical reasons such as chronic     external otitis or external skin irritation. The device is also available for patients who     are dissatisfied with the conventional hearing aids because of poor sound quality, feedback     or occlusion of the ear canal. To date, more than 1500 patients have been implanted in Europe     and about more than 600 patients in France. The aim of the present study is to compare in a     randomized study the performances of the system to those of the conventional hearing aid in     patients with similar degree of hearing loss.   "
199484|NCT00451516|"     SJW has the greatest evidence of herbal medicine efficacy in treating MDD. In treating     anxiety, kava has the greatest evidence of efficacy. As comorbidity of MDD and anxiety     commonly occurs, it is conceivable that a combination of an established antidepressant agent     such as SJW and an established anxiolytic agent such as kava may effectively treat MDD     presenting with comorbid anxiety. It is possible that a beneficial synergistic effect may     also occur between SJW and kava, improving the treatment outcomes in MDD with comorbid     anxiety, than by the individual substances alone. Determination of this is not addressed in     this study due to limitations of time and resources. The determination of the strength of the     SJW-kava combination will be ascertained by comparing similar trials using SJW and kava     mono-therapy in addressing MDD and GAD.      The hypothesis is that a combination of SJW and kava will reduce MDD occurring with comorbid     anxiety more than placebo.   "
199485|NCT00451529|"     Patients with a moderate to severe carotid atherosclerotic plaque are at risk for stroke and     this risk increases with increasing degree of stenosis. It has been shown that carotid     endarterectomy in symptomatic patients with a carotid artery stenosis of 70-99% is highly     beneficial. However, the beneficial effect of surgery in patients with symptomatic 30-69%     stenosis is not clear yet.A clear beneficial effect of surgery in the 30-69% stenosis group     might be found in a sub-group of patients whom are at greater risk for stroke. Definition of     this sub-group might be achieved by plaque characterization, since rupture of a vulnerable     plaque is the main cause of stroke due to carotid artery stenosis.This study will include     patients with a 30-69% carotid artery stenosis, and assess plaque composition by MRI, the     degree of plaque inflammation by FDG-PET, and the amount of microembolization by transcranial     Doppler ultrasound. The main purpose of this study is to assess whether one or a combination     of each of these imaging methods can predict the occurrence of a (recurrent) ischemic stroke.   "
199486|NCT00451542|"     This study is a retrospective chart review of patients treated for bipolar disorder at the     TVAMC in the past four years cross-referenced with the electronic pharmacy file for having     received a prescription of divalproex or lamotrigine.   "
199487|NCT00451555|"     The primary purpose of this study is to help answer the following research question: whether     enzastaurin given together with fulvestrant can help patients who have breast cancer and make     the tumor smaller or disappear and for how long.   "
199488|NCT00451568|"     Background: PCOS is a common condition with a prevalence of 5-8 % in premenopausal women.     More than 50% of PCOS patients are insulin resistant and have a diabetes risk 5-8 times     higher than age- and weight-matched controls. Studies using insulin sensitizers in PCOS found     increased insulin sensitivity and decreased insulin levels to be followed by decreased     androgen levels and improved ovulatory function. No studies however, evaluated the long term     effects of insulin sensitizing treatment.      Oral contraceptives normalize menstrual cycles and suppress androgen levels in PCOS, however     no long-term studies evaluated the effects of combined treatment with metformin and oral     contraceptives in PCOS.      Design: Randomized open study in 3*30 PCOS patients. Patients are randomised to 24 months of     treatment with 1: metformin, 2: metformin and oral contraceptives or 3: oral contraceptives.      Primary outcome measures: fasting insulin, AUC insulin. Secundary endpoints: BMI, WHR, LH,     FSH, total and free-testosterone, c-peptid, urinary cortisol, AUC for insulin, glucose and     c-peptid during OGTT.      Inclusioncriteria:        1. Irregular menses or anovulaty cycles        2. High free testosterone > 0,035 nmol/l or hirsutism        3. PCO in vaginal US Criteria 1 and 2 OR 2 and 3.      Design:   "
199489|NCT00451581|"     Endoscopic papillary balloon dilation is as effective as sphincterotomy in treating bile duct     stone. However, a need to switch to sphincterotomy is noted in about 20% of cases receiving     dilation for lithotripsy. It is hypothesized that a longer dilation duration (5 min. vs. 1     min.) can decrease the need of switching to sphincterotomy.   "
199490|NCT00451594|"     To determine the long term effects of pulse high dose dexamethasone and conventional dose     prednisolone in treatment of adult patients with ITP.   "
199540|NCT00457795|"     This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in     patients with glaucoma or ocular hypertension   "
199491|NCT00451607|"     Autonomic nervous system (ANS) is an essential regulator for the homeostasis, circulatory and     respiratory systems. Heart rate variability, under the dependence of the parasympathetic and     orthosympathetic arms is a peripheral witness of its well functioning.      Activity ANS indices are technically measurable from the birth by non invasive cardiac     monitoring: in given environmental conditions. According to the individualized care given to     the baby, we can easily observe by frequential analysis, modifications of ANS level activity;     If for a full-term newborn, the balance of ANS allows him to adapt its cardiac frequency to     its internal and external environment (thermoregulation, baroreflex, sinus arrhythmia,     awakening state) , the premature birth is at the origin of a prolonged defect of global ANS     maturation, probably induced by external environmental and stress factors (pain,     stimulations, aggressive noise and lights). This disrupted maturation profile in case of     prematurity, was confirmed in two preliminary studies on premature babies reaching term for     gestational age.      We hypothesis that adapted sensorimotor care could decrease this stress and optimize the ANS     activity profile.      In a prospective study, by a non invasive real-time measure, we analyse impact of stress on     ANS activity in a premature population, hospitalized in our neonatal intensive care units.   "
199492|NCT00451620|"     The results from the DECODE Study have shown that postprandial (1 - 2 hours after a meal)     hyperglycemia (elevated blood sugar) is more common in elderly people with diabetes than     younger people with diabetes and is the best predictor of the development of complications.     The DECODE Study involved 6941 people who already had diabetes and 702 who did not have     diabetes. Diabetes is diagnosed when the blood sugar 1st thing in the morning is over 7.0     mmol/L. The DECODE Study showed that people at risk for diabetes can have a normal blood     sugar 1st thing in the morning but have a high blood sugar 2 hours after a meal and that     these people are at risk for developing heart disease and other complications of diabetes.     These people would not be identified as at risk if only a fasting blood sugar is done.     Studies in younger people with diabetes have shown that after a meal, insulin levels are more     like a person without diabetes and glucose (blood sugar) levels are lower with GlucoNorm than     with Glyburide. There is no data available that demonstrates this in elderly people with type     2 diabetes.      You have been invited to participate in this study because you have type 2 diabetes     controlled by diet and/or exercise or metformin only and are over 65 years of age.      The purpose of this study is to determine whether GlucoNorm has a greater effect than     Glyburide on insulin levels and glucose (blood sugar) levels after a meal in elderly people     with type 2 diabetes who control their diabetes with diet and exercise.   "
199493|NCT00451633|"     A randomized, double blind, placebo-controlled study employing a mixed parallel group and     fixed sequence cross-over design.      Patients will be randomized to one of two treatment groups ('E2007' or 'Placebo') in a 1:1     ratio and receive investigational drug treatment concomitant with their standard     individualized anti-Parkinsonian therapy for a total of six weeks. Investigational drug     treatment for patients in the E2007 treatment group will be started 2 mg E2007 o.d. but will     be escalated to 4 mg E2007 o.d. after three weeks.   "
199494|NCT00451646|"     The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison     to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral     nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and     coagulation variables, vital signs and adverse events. Further objectives to evaluate are the     influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative     properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red     blood cells and serum.   "
199495|NCT00451659|"     This study is a retrospective chart review of recently deployed veterans who served during     the Iraq conflicts and were seen at the TVAMC in the outpatient Primary Care outpatient     clinic that was recently set-up for newly returning veterans since its inception through July     1, 2005. Identical data will be collected on non-combat veterans that were seen in other     primary care clinics at the Tuscaloosa VA Medical Center during June 2004 and July 1, 2005.     This information will be used for comparison with the Iraqi veterans group. The data will be     retrieved from a computerized list of these patients. Charts will then be examined to     determine sociodemographic, medical, psychiatric, and health care utilization     characteristics.   "
199496|NCT00451672|"     we propose that bromocriptine may be an alternative treatment of primary aldosteronism, both     APA and BAH.   "
199497|NCT00451698|"     Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can     cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to     the heart bypass portion of surgery may protect the infant human heart and brain from injury.      This randomized clinical trial will involve 120 children, age 6 weeks to 18 years, requiring     heart bypass surgery for congenital heart defects.   "
199498|NCT00451711|"     The purpose of this trial is to see which dose of liposomal amphotericin B is the safest when     used as a preventer against invasive fungal infection in patients with acute leukaemia who     are undergoing chemotherapy.   "
199499|NCT00451724|"     The purpose of this study is to compare how well three different doses of ketamine, given as     a spray into the nose, help to sedate children and help them tolerate repairs of cuts on     their faces.   "
199510|NCT00451867|"     The purpose of this study is to investigate the safety and effectiveness of a medication     called CellCept in treating refractory (has not responded to other treatments) interstitial     cystitis.      CellCept belongs to a class of medications called immuno-suppressants. Immuno-suppressants     work in the body by reducing the immune system's ability to produce certain reactions that     can cause inflammation. In some people, the inflammation produced by their immune system can     damage healthy tissues and cause symptoms of pain and discomfort. CellCept is approved by the     U.S. Food and Drug Administration (FDA) for use in patients who have had an organ transplant.     When used in combination with other drugs, CellCept helps to prevent the rejection of the     transplanted organ and is used widely in patients who have received kidney, liver and heart     transplants. CellCept is also frequently used but not FDA approved for the treatment of     severe rheumatoid arthritis which is a disease caused when the body's immune system acts     against healthy tissues in the joints.      Due to its special activity, CellCept may be useful in treating certain inflammatory diseases     or conditions like interstitial cystitis.   "
199541|NCT00457808|"     The purpose of this study was to determine if rapamycin reduced angiomyolipomata volume in     patients with tuberous sclerosis complex or lam.   "
199500|NCT00451737|"     The six-minute walk test had been used to assessment the cardiopulmonary parameter in     patients with lung and heart disease. And it has good reliability and validity. It has been     used extensively in research into the aerobic capacity in patients of peripheral vascular     disease, neural system disease, and even the muscular-skeletal system disease, such as     osteoarthritis, total hip or knee arthroplasty. There were studies investigate the predictors     based on cardiopulmonary factors, neuromuscular and skeletal factors of the six-minute walk     distance. But the last is the neuromuscular and skeletal factors.      The purpose of this study is to investigate the correlations between the six-minute walk     distance and neuromuscular parameters: muscle function (including muscle endurance, muscle     strength and muscle power), knee proprioception, and standing balance. For that it could be     more useful for evaluation and treatment patients in clinic.      The study was planed to select 100 subjects, they are older than 65 years old with     independent walking and without any diagnosis or symptoms about cardiopulmonary or neural     disease. The evaluation are including knee proprioception (closed chain, active-active test),     six-minute walk test, one leg standing balance test (open and close eyes for 30 seconds),     quadriceps muscle strength at velocities of 600/s,1200/s and 1800/s, quadriceps muscle power     at 1800/s, and quadriceps muscle endurance.      To investigate the correlations between the six-minute walk distance and characteristics of     subjects, the correlations between six-minute walk distance and neuromuscular parameters,     including quadriceps muscle function (strength, endurance and power), knee proprioception,     and one leg standing balance. And to analyze what’s the most contribution to the six-minute     walk distance.   "
199501|NCT00451750|"     The aim of this prospective, double-blind, placebo-controlled, randomized study is to     investigate if glucocorticoid treatment, in combination with exposure therapy, helps to     reduce phobic fear in patients with phobia.   "
199502|NCT00451763|"     Idiopathic Macular Telangiectasia is characterized by incompetent and dilated retinal     capillaries in the foveolar region of unknown cause for retinal telangiectasia.      In Idiopathic Macular Telangiectasia, proliferative changes occur in the deep retinal     capillary network, leading to intraretinal neovascularization that, unlike in age-related     macular degeneration, seems to be retinal rather than choroidal in origin. Before the     hemorrhagic and fibrotic state, these vessels may lead to exudation and decrease in the     visual acuity. Long-term visual prognosis in patients with this complication may be poor and     treatment with laser photocoagulation is unproven. Although newly reported treatment, by     photodynamic therapy for neovascular membrane associated with Idiopathic Macular     Telangiectasia, may show vision and angiographic stability in a few cases, the improvement     may be transient. VEGF has been implicated as the major angiogenic stimulus responsible for     neovascularization in AMD, ensuing specific anti-VEGF treatment in these cases.      The purpose of the study is to evaluate intravitreal injection of bevacizumab (1.25mg/0.05ml)     in the treatment of Idiopathic Macular Telangiectasia.   "
199503|NCT00451776|"     Because of its hemodynamic safety, etomidate is widely used for anaesthesia induction of     cardiac surgery. It can also cause adrenal insufficiency during the following 48 hours ( 11     betahydroxylase inhibition ). So it could increase hemodynamic dysfunction caused by the SIRS     following cardiopulmonary bypass.      A previous observational study found more adrenal insufficiency and need for vasopressive     support therapy in the etomidate group versus another propofol induced group.      The aim of our work is to compare hemodynamic dysfunction following induction with etomidate     for cardiac surgery with ECC. The control group would be induced by Propofol. 94 patients     would be included.   "
199504|NCT00451789|"     Introduction and Aims:      The objective of this prospective study is to evaluate the risk factors of minor head injury     in all consecutive patients of one year.   "
199505|NCT00451802|"     Biomedical and biotechnology industry is internationally regarded as the most brilliant star     performer of the future. The development of biomedical depends on a high quality academic     research environment, while innovation and uniqueness should be emphasized for the     development of biotechnology industry. The successful development of biotechnology industry     will be impossible if the development is not based on extensive and in-depth research work     and verification acquired from clinical implementation. Based on these concepts, the     resources of research materials, especial of human being, are going to be essential. Thus, a     programmable and systematic collection of clinical specimen would become one of the potential     properties in hospital. This is a two-year pilot scheme, and was designed to start collecting     specimen from “Health Management Center” in NTUH. This pilot scheme will address important     issues of manpower, finances, and data merging for evaluation of biotechnological related     specimen collection, such as cell or tissue bank, in the future.   "
199506|NCT00451815|"     To assess the preliminary safety and tolerability of multiple oral doses of BIIB014 in     subjects with early PD.   "
199507|NCT00451828|"     The overall objective of the CAP study was to determine genetic influences on efficacy of     simvastatin treatment with regard to LDL cholesterol reduction and changes in other markers     of cardiovascular disease risk.   "
199508|NCT00451841|"     Cough is the most common complaint for which patients seek medical attention in the United     States, accounting for approximately 1 billion dollars in health care expenses annually.     Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of     all cases. The majority of these patients with GERD-induced cough have no classic heartburn     symptoms, so this important cause of cough can thus be difficult to detect.      Our hypothesis is that changes in exhaled breath condensate (EBC) pH can be used as a     sensitive and non-invasive marker to identify subjects with cough caused by acid reflux.   "
199509|NCT00451854|"     The purpose of this study is to determine the influence of drug testing on risk and     protective factors of substance abuse among adolescents; examine whether drug and alcohol     testing among high school athletes leads to reduced drug and alcohol use; and assess the use     of drugs and alcohol among student athletes and non-athletes.   "
199511|NCT00451880|"     The purpose of this study is to determine the safest dose of the multiple Raf kinase     inhibitor (including c-Raf, B-Raf, and the activated mutant B-RafV600E) XL281, how often it     should be taken, and how well subjects with cancer tolerate XL281. This study will also     determine how the body reacts to XL281 when it is taken with and without food, and with and     without Pepcid (famotidine), a drug that inhibits stomach acid production.   "
199513|NCT00451906|"     This single arm study will assess the safety and efficacy of Avastin combined with     platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous     non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in     combination with platinum-based chemotherapy or in combination with any standard of care     NSCLC first-line chemotherapy used in line with the licensed national prescribing     information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week     cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of     chemotherapy cycles until disease progression, and the target sample size is 500+     individuals.   "
199514|NCT00451919|"     Sickle cell disease is an inherited blood disorder that affects red blood cells (RBCs).     People with sickle cell disease frequently experience anemia, or a low number of RBCs. RBCs     are responsible for carrying oxygen to the brain and other body tissues that need oxygen to     function properly. The purpose of this study is to determine what changes, which were     possibly caused by anemia, exist in the brains of individuals with sickle cell disease.   "
199515|NCT00451932|"     A proof of concept study to evaluate the safety and effectiveness of FK778 in liver     transplant patients.   "
199516|NCT00451945|"     The purpose is to investigate and evaluate two new diagnostic methods using ultrasound in the     staging of cervical cancer.        1. 3-D-ultrasound of the tumour to estimate its volume and local spread        2. Fusion of PET/CT and ultrasound to evaluate and biopsy lymph nodes.   "
199517|NCT00451958|"     Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486     CS21A study. The study continued until all non-discontinued participants had received     treatment for at least 5 years.   "
199518|NCT00451971|"     Primary Objectives        1. To test the feasibility, in patients with active rheumatoid arthritis, of using an          'aggressive' treatment algorithm to bring a short term treatment objective (STO) within          the normal or an arbitrarily defined 'desirable' range.        2. To determine whether patients with active rheumatoid arthritis randomly allocated to a          particular STO show a reduced rate of Magnetic resonance imaging damage progression at          two years compared to those randomly allocated to usual care.      Secondary Objectives        1. To establish the relationship between achieving a given STO or combination of STOs and          damage progression.        2. To identify the characteristics of responders and non-responders with respect to STO          achievement and predictors of greater and lesser degrees of damage progression.   "
199519|NCT00451984|"     The response to vaccination for hepatitis is reduced in patients with HIV infection. The     hypothesis of the study is that adjuvant interleukin-2 administered subcutaneously at the     time of vaccination improves the response rate.   "
199520|NCT00451997|"     The goal of this clinical research study is to learn if the combination of Gleevec (imatinib     mesylate) and low doses of Cytarabine (ara-C) may help to control leukemia while causing     fewer side effects than standard high dose chemotherapy.   "
199521|NCT00452010|"     Prior studies showed contradictory results about the best type of TENS in chronic pain     pathology.      Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low     back pain or chronic lumbo-radiculalgia.      The functional ability score is evaluated by the Roland scale at 6 weeks.   "
199522|NCT00452023|"     The goal of this clinical research study is to see if Pegasys (IFN-alpha2a) can help to     control the disease in patients with essential thrombocytosis (ET), polycythemia vera (PV),     agnogenic myeloid metaplasia/myelofibrosis (AMM/MF), or Philadelphia chromosome-negative     chronic myeloid leukemia (Ph-negative CML). The safety of this treatment will also be     studied.   "
199523|NCT00452036|"     The objective of this prospective study is to evaluate the reliability of plain x-rays     vs.cranial computed tomography as a screening method for skull fractures and its prognostic     value for intracranial bleeding (ICB).   "
199524|NCT00452049|"     Secondary hyperparathyroidism (HPT) is a known complication of chronic renal failure.     Elevated concentrations of parathyroid hormone (PTH) play a role not only in the pathogenesis     of renal bone disease, but also in the development of cardiovascular risk factors such as     disturbed lipid metabolism, glucose intolerance, and hypertension. HPT is also known to play     an important role in the development of structural abnormalities of both large arteries and     the heart (left ventricular hypertrophy, interstitial fibrosis). In the last couple of years     there has been increasing evidence from animal studies that the endothelium is a target organ     of PTH.      Hypothesis: PTH has clinically relevant effects on renal hemodynamics, renal function and     endothelial function.      Aims:        1. To evaluate the effect of parathyroidectomy (PTX) on renal hemodynamics in stable renal          transplant recipients        2. To evaluate the effect of PTX on endothelial function in stable renal transplant          recipients/chronic kidney disease (CKD) stage 5 patients        3. To evaluate the effect of PTX on blood pressure in stable renal transplant          recipients/CKD stage 5 patients   "
199525|NCT00457600|"     The emergency department (ED) constitutes a high-risk environment for errors and poor quality     of care. Pediatric patients are at increased risk of medical errors. We postulate that     implementation of a patient-centered health information technology - ParentLink - can address     system-level deficiencies and the unique “just-in-time” information needs of ED physicians     and the parents of ill children. The proposed work delivers an innovative product – an     electronic interface linked to a pediatric knowledge base that integrates parent-derived data     with best practices for safe and effective emergency care across common pediatric disease     conditions: otitis media, urinary tract infections, asthma, and head trauma. The study has     two aims, the first of which addresses critical gaps in data capture: to evaluate the     completeness and accuracy of information on symptoms, disease condition, medications and     allergies generated by parents using ParentLink versus information documented by ED     physicians and nurses, using structured telephone interviews as a gold standard. The second     aim measures the ParentLink’s impact on ED patient safety and quality, specifically: a) the     error rate for ordering and prescribing of medications during ED care, and b) the percent of     ED visits that adhere to national evidence-based guidelines. Parentlink will be rigorously     evaluated in a clinical trial at two diverse ED sites and will use a sequential,     non-randomized observational design with two intervention and two control periods to measure     the effects of ParentLink on data capture and safety and quality of patient care.   "
199526|NCT00457613|"     Septic shock is the most common cause of death in patients requiring intensive care. The     kidney is one of the first organs to fail, stressing the importance to search for clinical     interventions that may protect the kidneys during sepsis.      Alkaline phosphatase functions as a host defence molecule and is present in many cells and     organs (e.g. intestine, placenta, liver, kidney and bone). Alkaline phosphatase has a dual     mode of action. First, it binds to and, subsequently, dephosphorylates lipopolysaccharide     (LPS). Second, the enzymatic reaction product monophosphoryl-LPS is a non-toxic substance for     mammals which acts as a partial antagonist on the LPS receptor complex. In several animal     studies, administration of alkaline phosphatase attenuates the inflammatory response and     reduces mortality.      It is unknown whether these results can be extrapolated to septic patients . We studied the     effects of alkaline phosphatse administration on kidney damage and function in patients with     severe sepsis or septic shock.   "
199527|NCT00457626|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term     use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.   "
199528|NCT00457639|"     To evaluate the efficacy and safety of cholic acid therapy in treating lipodystrophy patients     with hepatic steatosis. This is a randomized, double-blind, placebo-controlled cross-over     study.   "
199529|NCT00457652|"     Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?   "
199530|NCT00457665|"     The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not     known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and     reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.      The project therefore has the following aims: 1) to characterize metabolic abnormalities and     changes in body fat distribution, 2) to develop objective criteria for defining the syndrome     and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the     lipodystrophy syndrome in HIV-infected patients.   "
199531|NCT00457678|"     The purpose of this study is to demonstrate that Visudyne-Lucentis-dexamethasone (V-L-D)     triple therapy will give similar efficacy and safety results as Lucentis monotherapy.   "
199532|NCT00457691|"     The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan,     Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI     chemotherapy without adding sunitinib as the first line treatment of patients with metastatic     colorectal cancer.   "
199533|NCT00457704|"     Methicillin resistant Staphylococcus aureus (MRSA) which is one of the principal multidrug     resistant organisms found in the hospitals all over the world, has recently emerged in the     community. However, for the moment (2002), the hospital remains the principal reservoir of     MRSA so far and the patients discharged with a MRSA carriage can be the source of MRSA     spreading in the community. In particular patients admitted to home care (HC) from acute care     facilities represent a patient group with a high risk of MRSA carriage and of being the     source of MRSA spreading in the community. The objective of this study is to determine     whether HC patients are effectively a MRSA reservoir and a source for MRSA spreading in the     community.      For that, from February 2003 to March 2004 any adult patient (except obstetric patient)     (approximately 3360 patients for 16 HC settings), will be screened [nasal and skin lesion (if     any) swabs] for MRSA carriage within the 48 h before his/her transfer. The patients found to     be MRSA carriers will be visited by a physician who will ask patients as well as family     members to participate in the study. Each patient and each family member who will have given     agreement to participate, will be sampled (nasal swab for both patient and family members,     and skin lesion swab for the patients with skin lesions) every month for 12 months by the     nurse of the HC setting in which the patient will have been admitted. As soon as the patient     will be discharged from HC setting and if the 12 month survey is not finished, patient and     family member swab sampling will be performed by the nurse of the research team (NRT) every 3     months until the end of the survey period. These swabs will be transmitted by the NRT to the     research center and analyze by the microbial technician of the research center. The     bacteriological survey will be accompanied with an epidemiological survey in order to     determine the risk factors for a long term MRSA carriage in the patients admitted in HC and     also the risk factors for transmitting MRSA to their family.      This multi-centre and multi-investigator study will be performed over a period of 32 months     (1 month to prepare the study, 13 months to screen patients with regard to MRSA carriage     before their transfer from acute care settings into HC settings, 12 months to survey HC     patients and their family members and 6 months to analyze data and prepare publications).     Such a study will provide us with descriptive and quantitative data on MRSA strains     introduced in the community by HC patients. From the analysis of risk factors of MRSA     transmission from these patients to their family members, suggestions to limit this     transmission might be drawn.   "
199534|NCT00457717|"     This study was designed to compare the difference of using atropine eyedrops alone from     atropine combined with the stimulation of auricular acupoints therapy in reducing myopia     progression.   "
199535|NCT00457730|"     Many patients with Multiple Sclerosis experience pain that is caused by the effects of MS on     the nervous system.      The purpose of this study is to see if an investigational drug (Duloxetine) will reduce pain     in subjects with MS.      The US Food and Drug administration (FDA) has approved this drug for use with depression or     pain from diabetes.However, it is considered investigational for this study because it has     not been approved for patients with MS.      This study will recruit patients with MS who have central pain which is 4 or greater on a     scale of 1-10. Patients must have experienced pain for 2 months or longer prior to begining     the study.The study will last 10 weeks, patients will be randomized either Duloxetine or     placebo and will be carefully monitored throughout the study. Patients will keep pain/sleep     diaries during the study period and will be provided Ibuprofen for pain control.   "
199536|NCT00457743|"     Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248)     following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by     reviewing the safety and tolerability.      Phase II;To determine the objective tumor response and the safety of Sunitinib malate     (SU011248) at the clinically recommended dose.   "
199537|NCT00457756|"     This is a double-blind, placebo-controlled study to assess the effectiveness of BiosLife in     lowering serum LDL cholesterol and raising HDL cholesterol. BiosLife is a natural supplement     (mixed in water and taken twice daily) which contains guar gum and other natural soluble     fibers, phytosterols, policosanol, and a proprietary chrysanthemum extract. Approximately 100     subjects with baseline LDL cholesterol of 110-190 mg/dL will be randomized in a 2:1 ratio to     BiosLife or a look-alike placebo. Changes in lipids from baseline will be assessed at 6 weeks     and 12 weeks.   "
199538|NCT00457769|"     Medications for memory improvement are available but they may not actually improve the     ability to do real world tasks. The purpose of this research study is to determine if a     medicine used to treat memory problems donepezil(Aricept) enhances the ability to remember     steps of functional tasks and the actual ability to perform tasks relevant to real-life     independence. Aricept is an FDA approved medication for the treatment of Alzheimer's disease.     Aricept is an investigational drug for the purposes of this study, and is not approved for     this purpose.   "
199539|NCT00457782|"     The aim of this study is to determine the safety, tolerability and dose-limiting toxicities     of KW-2478 and to determine the Maximum Tolerated Dose and recommended Phase II dose for     patients with relapsed/refractory MM, CLL or B-cell NHL.   "
199542|NCT00457821|"     The purpose of this study was to evaluate the safety and tolerability of ivacaftor in     patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation     in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent     and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR     protein. Potentiators are pharmacological agents that increase the chloride ion transport     properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA)     activation.   "
199543|NCT00457834|"     Cardiac resynchronization therapy (CRT) is used to treat dilated heart failure with     discoordinate contraction. Dyssynchrony typically stems from electrical delay leading to     mechanical delay between the septal and lateral walls. Right ventricular apical pacing might     be associated with long-term adverse effects on left ventricular function, and alternative     pacing sites such as high septal or RVOT has been suggested. Previous studies have however     been conflicting. The aim of this study is to determine if bi-ventricular pacing from RVOT +     LV is better than RVapex+LV. To avoid influence from possible atrial delay only patients with     chronic atrial fibrillation are included. All patients will receive a bi-ventricular     pacemaker with 3 leads placed in RVapex, RVOT and via coronary sinus to pace the left     ventricle. After a run in period (to determine if AV-junction ablation is necessary) the     patients are randomised to one of the following pacing configurations: RVOT+LV or RVapex+LV     with cross-over after 3 month.   "
199544|NCT00457847|"     Primary graft dysfunction (PGD) is a severe lung injury that can occur in the days following     lung transplant surgery. The purpose of this study is to identify genetic factors that may     put someone at risk for developing PGD.   "
199545|NCT00457860|"     RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal     cells. This may be an effective treatment for chronic lymphocytic leukemia (CLL),     prolymphocytic leukemia (PLL), or small lymphocytic lymphoma (SLL that has not responded to     chemotherapy, surgery or radiation therapy.      PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015     immunotoxin in treating patients who have chronic lymphocytic leukemia, prolymphocytic     leukemia or small lymphocytic lymphoma that has not responded to treatment   "
199546|NCT00457873|"     Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have     serious complications. It has recently been suggested that isotonic saline may be a more     appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare     isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support     in order to:      Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial     comparing these solutions.      Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of     hyponatremia (Na <136 mmol/L) between patients receiving isotonic and hypotonic intravenous     fluids at at least 50% of the traditional maintenance rate for an interval of at least 8     hours.      Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.   "
199547|NCT00457886|"     The purpose of this study is to measure hormones in the blood known to affect the timing of     delivery after a single injection of 17-P in order to help understand its mechanism of action     in preventing preterm delivery.   "
199548|NCT00457899|"     The purpose of this study is to determine whether increasing the amount (dose) of quetiapine     IR (immediate release formulation) more rapidly than conventional dose increases, improves     the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a     psychiatric assessment scale that measures both positive and negative symptoms - in patients     with acute schizophrenia or schizoaffective disorder.   "
199549|NCT00457912|"     The objective of this study is to identify and maintain a registry of well-characterized     limb-girdle muscular dystrophy (LGMD) patients. Patients seen as part of this study may be     candidates for future treatment trials based on their defined genetic classification of LGMD.     In the course of this study, the investigators will perform a muscle biopsy and DNA testing     in an unlimited number of patients with clinically diagnosed LGMD. The genetic testing will     be extended to the family of the study subject in order to better understand true genetic     defect.   "
199550|NCT00457925|"     This is a phase one study investigating the absorption, distribution, metabolism and     excretion of GSK221149A in six healthy women of non-child bearing potential.   "
199551|NCT00458588|"     RATIONALE: The amount and type of fat in the diet may affect hormone levels, bone mineral     density, and breast density later in life. This may affect the risk of developing breast     cancer. Learning about the long-term effects of diet on hormone levels, bone mineral density,     and breast density may help the study of breast cancer in the future.      PURPOSE: This clinical trial is studying the long-term effect of adolescent diet on hormones     and breast cancer risk in women previously enrolled in the Dietary Intervention Study in     Children.   "
199552|NCT00458601|"     This study is designed to evaluate the clinical activity of CDX-110 vaccination when given     with standard of care treatment (maintenance temozolomide therapy). Study treatment will be     given until disease progression and patients will be followed for long-term survival     information. Efficacy will be measured by the progression-free survival status at 5.5 months     from the date of first dose.   "
199553|NCT00458614|"     The disposition of a number of drugs has been reported to be altered in patients with Cystic     Fibrosis (CF). Changes in pharmacokinetic parameters observed included increased volumes of     distribution and increased clearance of renally eliminated drugs. The purpose of this this     study is to characterize the pharmacokinetics of IV lansoprazole and its metabolites in     normal healthy children and children with Cystic Fibrosis (CF) ages 2 to < 10 years. It is     suspected that children with CF will have a more rapid clearance as compared to healthy     children.   "
199554|NCT00458627|"     In our previous study of Methacholine Challenge Tests (MCT) in preschool children, we found     that wheeze detection was associated with significant reduction in flows and vital capacity     values. We hypothesized that this finding is associated with trapped-air rather than the     children's loss of cooperation/concentration.      Objectives: To test this hypothesis by attempting plethysmography measurements during MCT.   "
199579|NCT00459004|"     The primary objective is to verify the dose-response relationship of rimonabant on body     weight change.      The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body     weight loss and on secondary criteria associated with comorbidities, and to evaluate the     safety and the pharmacokinetics of SR141716.   "
199555|NCT00458653|"     The main purpose of this study is to test the safety and determine the type and severity of     any side effects of the Dendritic Cell Fusion Vaccine given in combination with an autologous     transplant for patients with multiple myeloma. Autologous stem cell transplantation is a     standard therapy for multiple myeloma that is often successful in significantly decreasing     the amount of cancer. However, it is not a cure because at some point the multiple myeloma     generally begins to grow again. Cancer vaccines are investigational agents that try to     stimulate the immune system to recognize and fight against cancer cells. One type of cancer     vaccine uses an immune stimulating cell of the body known as a dendritic cell. Research has     shown that these dendritic cells can stimulate an immune response against the tumor.   "
199556|NCT00458666|"     Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused     by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains     coagulation activators, their role during pregnancy has not been elucidated. The current     study aimed to evaluate coagulation parameters in AF during human pregnancy.   "
199557|NCT00458679|"     We would like patients to be in a research study to determine the safety and effectiveness of     special cells that may make their own immune system fight their cancer.      To do this, we will put a special gene into cancer cells that have been taken from the     patients body. This will be done in the laboratory. This gene will make the cells produce     interleukin 2 (IL-2), which is a natural substance that may help their immune system kill     cancer cells. Additionally, we will stimulate the cancer cells with normal embryonic     fibroblasts (cells that develop into normal connective tissues in the body) so that they will     make another natural protein called CD40 ligand (CD40L). Studies of cancers in animals     suggest IL-2 performs better when mixed with CD40L.      Some of these cells will then be put back into the patients body with the goal that they will     act like a vaccine and stimulate their immune system to attack the CLL cells. Studies of     cancers in animals and in cancer cells that are grown in laboratories suggest that combining     substances like IL-2 and CD40L with cancer cells help the body recognize and kill cancer     cells. We have already conducted a study similar to this in patients with CLL. In that study,     the subjects received about three months of injections (shots). In those subjects we saw some     changes in the subject's immune system that might indicate that the modified cells were     helping their immune system fight the cancer. However, in most of the subjects this change in     the immune system went away after the injections were stopped.      In this study we want to see if we can make the change in the immune system last longer by     giving more injections over a longer period of time. We hope that this might produce a better     response directed at the CLL cells. We will also be looking at the effect on cells called     cancer stem cells which grow into the CLL cells we see in the blood. Specifically, this study     will allow subjects to receive the injections for up to one year.   "
199558|NCT00458705|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride     liposome and dexamethasone, work in different ways to stop the growth of cancer cells, either     by killing the cells or stopping them from dividing. Thalidomide may stop the growth of     cancer cells by blocking blood flow to the cancer. Giving bortezomib together with     doxorubicin hydrochloride liposome and dexamethasone followed by thalidomide, dexamethasone,     and bortezomib may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib     together with doxorubicin hydrochloride liposome and dexamethasone followed by thalidomide     and dexamethasone with or without bortezomib works in treating patients with multiple     myeloma.   "
199559|NCT00458718|"     The primary objective is to compare the efficacy of rimonabant 20 mg OD fixed dose plus     nicotine patch 21 mg OD with the combination rimonabant 20 mg OD fixed dose plus placebo     patch on abstinence from smoking in cigarette smokers motivated to quit.      Secondary objectives are to evaluate the clinical and biological safety of rimonabant     associated with nicotine replacement therapy during a 9-week treatment period and to evaluate     the effect of the combination on weight and craving.   "
199560|NCT00458731|"     This phase I trial is studying the side effects and best dose of bevacizumab and cediranib     maleate in treating patients with metastatic or unresectable solid tumor, lymphoma,     intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma. Monoclonal antibodies, such     as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer     cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. Cediranib maleate may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Bevacizumab and cediranib maleate may also stop the     growth of cancer cells by blocking blood flow to the cancer. Giving bevacizumab together with     cediranib maleate may kill more cancer cells.   "
199561|NCT00458744|"     RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I trial is studying the side effects and best dose of talotrexin in     treating young patients with recurrent solid tumors or leukemia that is recurrent or does not     respond to treatment.   "
199562|NCT00458757|"     In this study, we wish to find behavioral evidence for the question whether an amputation of     the arm can lead to changes in visual perception or motor responses to objects in     peripersonal space. We hypothesize that changes in the motor and somatosensory hand-related     cortices following amputation might lead to changes in parietal hand-related areas. The     consequence of these parietal changes should be reflected behaviorally in reduced     perception/attention/responses to hand-related objects in the space ipsilateral to the     amputation. We further hypothesize that the use of prosthetics may provide the necessary     visual feedback to maintain an intact hand representation and therefore lead to lesser     cortical reorganization in both visual and somatosensory cortical areas.   "
199563|NCT00458770|"     Cluster headache is characterized by unilateral excruciating head pain and autonomic     dysfunction. Hypothalamic overactivity was observed in nitrate-induced cluster-headache and     in only one case of spontaneous cluster headache 'Sprenger et al, 2004). This prompted the     application of hypothalamic deep brain stimulation. The aim of this data is to precise the     localisation of the hypothalamic activation.   "
199564|NCT00458783|"     The purpose of this study is to determine whether length of storage of RBC is related to     postoperative morbid outcomes in patients undergoing cardiac surgery.   "
199565|NCT00458796|"     RATIONALE: Zoledronic acid may help decrease the risk of broken bones, bone pain, and other     symptoms caused by bone metastases. It may also help patients live more comfortably.      PURPOSE: This randomized clinical trial is studying different schedules of zoledronic acid to     compare how well they work in treating patients with breast cancer that has spread to the     bone.   "
199580|NCT00459017|"     Despite knowledge regarding the importance of controlling patients' blood pressure (BP) only     30% of treated patients achieve BP goals. Our objective was to determine the effect of     frequent self measurements of BP in the patients' natural environment as a mean to improve BP     control. Our hypothesis was that frequent measurements of BP will reduce mean BP levels.   "
199566|NCT00458809|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body     temperature. Adding chemotherapy to hyperthermia and infusing it directly into the abdomen     may kill more tumor cells. Giving this treatment after surgery may kill any tumor cells that     remain after surgery.      PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal     hyperthermic perfusion with oxaliplatin in treating patients with stage IV peritoneal cancer     due to appendix cancer or colorectal cancer.   "
199567|NCT00458822|"     The purpose of this study in patients needing treatment for AL amyloidosis is to see how well     treatment with IV melphalan works and then, if some clonal plasma cells are still present     about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and     dexamethasone works to reduce the rest of the clonal plasma cell disease.   "
199568|NCT00458835|"     The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™     (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide     HFA-metered-dose inhaler (MDI). The administration of the study medication will be as     follows: three single doses, separated by a wash-out period. The study will provide further     data on the safety and tolerability of ciclesonide.   "
199569|NCT00458848|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A     peripheral stem cell transplant may be able to replace blood-forming cells that were     destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and     platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral     stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.      Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL     patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will     be implemented in patients pertaining to this category.   "
199570|NCT00458861|"     This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given     subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who     have previously had an inadequate response to treatment with anti-tumor necrosis factor     (anti-TNF) therapy.   "
199571|NCT00458874|"     The purpose of this study is to determine whether knowledge of abnormal results from a     noninvasive test for detection of subclinical atherosclerosis (carotid intima media thickness     [CIMT]), in addition to knowledge of cardiovascular disease (CVD) risk factors, enhances     adherence to healthy lifestyle behaviors in comparison to only CVD risk factor knowledge. We     believe that participants with CVD risk factors who have knowledge of their own CIMT test     results showing significant subclinical atherosclerosis will demonstrate better adherence to     therapeutic lifestyle change (TLC) than those subjects from whom the CIMT test information is     withheld.   "
199572|NCT00458887|"     RATIONALE: New ways to find out about hearing loss after treatment with chemotherapy may     improve the ability to plan cancer treatment and may help patients live more comfortably.      PURPOSE: This clinical trial is assessing ear damage in young cancer patients treated with     cisplatin.   "
199573|NCT00458900|"     In the Intensive Care (IC)-unit moxifloxacin treatment is often started with intravenous     administrations. As moxifloxacin is known to have a high oral bioavailability in healthy     volunteers, patients are switched to oral or enteral therapy as soon as possible. However, no     data on plasma levels for moxifloxacin during such a switch-therapy in IC-patients are     available. Therefore, this study aims to evaluate the moxifloxacin-plasma levels and their     inter-individual variability during IV to enteral switch therapy in IC-patients.   "
199574|NCT00458913|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as cisplatin, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving bortezomib together with     cisplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib     together with cisplatin works as first-line therapy in treating patients with malignant     mesothelioma.   "
199575|NCT00458926|"     Non-invasive positive pressure ventilation (NIV) refers to the provision of mechanical     ventilation without an artificial airway (for example, an endotracheal tube). Over the past     decade, evidence from randomized control trials has accumulated to demonstrate effectiveness     of the technique in avoiding intubation, reducing complications associated with intubation,     shortening ICU and hospital lengths of stay, and reducing mortality rates in selected     patients with acute respiratory failure. However, NIV is still underutilized at many medical     centers. The purposes of this project will be to acquire information related to NIV use, to     identify reasons for underutilization, to implement interventions that encourage more     appropriate use of NIV, and to evaluate the effectiveness of the interventions. Reliable     information on NIV use as well as analysis of reasons for underutilization will provide     insight into ways of enhancing NIV use. We will determine utilization rate, technology used,     patient diagnoses, duration of ventilator use and hospital stay, and success rates as     recorded on case report forms (CRFs). After completing the survey, we will provide an     educational program to randomly selected institutions (one-half of the total) aimed at     increasing the knowledge and skill of physicians, nurses, and therapists regarding use and     implementation of NIV. Data will be gathered for a second round with the same data-gathering     instruments used during   "
199576|NCT00458952|"     The purpose of this study is to determine whether iobenguane I 131 is safe and effective in     patients with malignant pheochromocytoma or paraganglioma.   "
199577|NCT00458978|"     This phase II trial is studying how well cediranib maleate works in treating patients with     recurrent or newly diagnosed metastatic head and neck cancer. Cediranib maleate may stop the     growth of head and neck cancer by blocking some of the enzymes needed for cell growth and by     blocking blood flow to the tumor.   "
199578|NCT00458991|"     The purpose of the study is to understand the effect of rhGH therapy on hepatic drug     metabolism in children with idiopathic growth hormone deficiency.   "
199581|NCT00459030|"     RATIONALE: Finding out which communication method affects a participant's decision to undergo     colorectal cancer screening may help increase the number of participants who undergo     screening. It is not yet known which communication method is more effective in increasing how     often participants undergo colorectal cancer screening.      PURPOSE: This randomized clinical trial is studying traditional print communication methods     to see how well they work compared with simple electronic communication methods or usual care     in increasing how often older women undergo colorectal cancer screening.   "
199582|NCT00459043|"     In this research study, the researchers are comparing the combination of docetaxel and     Zactima with docetaxel alone to see if the combination of the two drugs will be more     effective than docetaxel alone. Zactima blocks the actions of three substances in the body:     1)vascular endothelial growth factor reception (VEGFR); 2)epidermal growth factor receptor     (EGFR); and 3) rearranged during transfection (RET). VEGFR stimulates the growth of new blood     vessels. When certain proteins bind to the VEGF receptor, a process begins to occur which     allows new blood vessels to be made that provide blood to the cancer cells. Zactima is     thought to block these proteins from binding to the VEGF receptor, which would then block the     process that creates new blood vessels. EGFR controls how quickly cells grow and multiply.     RET is thought to have a particularly significant role in the development and growth of     squamous cell tumors. The actions of Zactima are very different from the way standard     chemotherapy drugs work. Researchers believe that Zactima might have different side effects     from other cancer treatments so another one of the purposes of this study is to assess the     side effects caused by the drug.   "
199583|NCT00459056|"     The purpose of this study is to compare the effects of two different combination therapies     for high blood pressure on vascular health.   "
199584|NCT00459069|"     The main purpose of this study is to test the safety of dendritic cell tumor fusion study     vaccine and to determine the type and severity of any side effects associated with this study     vaccine. Cancer cells have unique markers that distinguish them from normal cells of the     body. These markers can potentially serve as targets for the immune system. Dendritic cells     are normally found in small amounts in the body and are responsible for immune responses     against foreign substances that enter the body. Animal studies have shown that these fused     cells can stimulate powerful anti-tumor responses.   "
199585|NCT00459082|"     Blind randomized trial of a single bolus dose of dexmedetomine followed by a continuous     infusion (CIVI) for up to 24 hours in infants who immediately post-operative from cardiac     surgery and require tracheal intubation with mechanical ventilation in the post-operative     period. Three bolus and infusion dose will be administered to a total of 36 patients.   "
199586|NCT00459108|"     This phase II trial is studying how well dasatinib works in treating patients with advanced     liver cancer that cannot be removed by surgery. Dasatinib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth.   "
199587|NCT00459121|"     RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving vandetanib together     with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving vandetanib together with carboplatin     and paclitaxel works in treating patients with stage I, stage II, or stage III non-small cell     lung cancer that can be removed by surgery.   "
199588|NCT00459134|"     RATIONALE: L-arginine supplements may improve the quality of life and sexual function in     women who are cancer survivors.      PURPOSE: This randomized clinical trial is studying an L-arginine supplement to see how well     it works compared with a placebo in treating women who are cancer survivors.   "
199589|NCT00459160|"     The goal of this study will be to determine if a lower than normal blood pressure during     surgery for bleeding in the abdomen or chest will result in decreased bleeding and decreased     chance of death.   "
199590|NCT00459173|"     The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg     and 20 mg) for the maintenance of abstinence from smoking.      Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the     clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month     treatment period and to evaluate the pharmacokinetics of the drug.   "
199591|NCT00459186|"     The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel     plus prednisone in men with hormone refractory, metastatic prostate cancer (Phase I).      Once an appropriate dose is reached, the purpose then will be to determine the response rate     of docetaxel plus RAD001 (Phase II).   "
199592|NCT00459212|"     This phase I trial is studying the side effects and best dose of GTI-2040 in treating     patients with relapsed, refractory, or high-risk acute leukemia, high-grade myelodysplastic     syndromes, or refractory or blastic phase chronic myelogenous leukemia. Drugs used in     chemotherapy, such as GTI-2040, work in different ways to stop the growth of cancer or     abnormal cells, either by killing the cells or by stopping them from dividing.   "
199593|NCT00459225|"     Anemia is a common disorder in infants with one working chamber of the heart that pumps     blood. Anemia is when the level of healthy blood cells becomes too low. This may cause other     health problems because red blood cells contain hemoglobin, which carries oxygen (needed for     survival) to different parts of the body.      This study will look at the role of iron in preventing anemia in infants with one pumping     chamber. The importance of iron therapy will be examined.      Hypothesis: Prophylactic use of iron in infants with single ventricle is effective in     preventing anemia.   "
199594|NCT00459238|"     RATIONALE: Telephone-based cancer education and counseling may help participants learn about     ways of preventing cancer and choose a lifestyle that will help them stay healthy as they     grow older.      PURPOSE: This randomized clinical trial is studying telephone-based cancer education and     telephone-based counseling to see how well they work compared with telephone-based cancer     education alone in young participants.   "
199621|NCT00459602|"     The purpose of this study is to describe the outcomes of laparoscopic incisional hernia     repair surgery and to record the outcomes of patients after surgery.   "
199595|NCT00459251|"     This main purpose of this study is to understand the difference and distribution of     drug-metabolizing enzyme genetic polymorphisms among Taiwan ethnicities. The subjects of     study include Atayal, Pawlan, Yami, Tsou, Ami, Minnan and Hakka. We anticipate establishing a     reference for the clinical medication in various ethnic groups according to the difference     and distribution of the genetic polymorphisms.   "
199596|NCT00459264|"     The purpose of this study is to determine whether daily folic acid supplements can prevent     new episodes of mood disorder in young people (aged 14-24 years) of biological parents with     current or past history of depression or bipolar disorder.   "
199597|NCT00459277|"     Cancer patients taking regular medication for their pain often still have episodes of severe     pain that 'break through' despite their background pain treatment. Fentanyl is a strong,     short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains     fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal     spray. This study will test the efficacy and safety of Nasalfent in the treatment of     breakthrough cancer pain.   "
199598|NCT00459290|"     RATIONALE: Progesterone can cause the growth of ovarian epithelial cancer , primary     peritoneal cancer, or fallopian tube cancer. Hormone therapy using mifepristone may fight     ovarian epithelial cancer and primary peritoneal cancer by lowering the amount of     progesterone the body makes.      PURPOSE: This phase II trial is studying the side effects and how well mifepristone works in     treating patients with recurrent or persistent ovarian epithelial cancer, primary peritoneal     cancer, or fallopian tube cancer.   "
199599|NCT00459303|"     This study is to compare intraindividually the functional vision provided by two different     posterior chamber intraocular lenses: AMO Tecnis Z9000 and Alcon SA60AT Acrysoft. To see if     the aspherical intraocular lenses provide better functional vision than traditional spherical     intraocular lenses.   "
199600|NCT00459316|"     Bacterial meningitis infection is common in youth 2 to 24 years of age in the United States.     This disease can be treated by antibiotics, but mortality rates associated with meningitis of     up to 53% have been estimated. Vaccination against meningitis may be effective in preventing     this disease, especially for HIV-infected youth who have weakened immune systems. The purpose     of this study was to determine the safety of and immune response to a preventive meningitis     vaccine in HIV-infected youth.   "
199601|NCT00459329|"     The purpose of this study is to test the effectiveness of a home-based depression treatment     intervention called Program to Encourage Active, Rewarding Lives (PEARL). We hypothesize     that over a 12-month period, compared to usual care, those receiving the PEARL intervention     will show more improvement with their depression, have higher quality of life and function,     and use fewer medical services.   "
199602|NCT00459342|"     Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. This phase II trial is studying how well dasatinib works in treating patients with     stage IIIB, stage IV, or recurrent non-small cell lung cancer.   "
199603|NCT00459355|"     The purpose of this study was to test the effectiveness of a new multimodal educational     intervention to improve home safety for persons with dementia of the Alzheimer's type and     their home caregivers.   "
199604|NCT00459368|"     The purpose of this study is to determine whether providing patient medication adherence     information on inhaled corticosteroid use to clinicians will result in improved patient     adherence and asthma control.   "
199605|NCT00459381|"     This phase II trial is studying the side effects and how well pazopanib works in treating     patients with recurrent glioblastoma. Pazopanib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor   "
199606|NCT00459407|"     Green tea extract contains ingredients that may prevent or slow the growth of prostate     cancer. This phase I trial is studying how well green tea extract works in treating patients     with prostate cancer undergoing surgery to remove the prostate   "
199607|NCT00459420|"     Many patients with Parkinson's disease (PD) have sleep problems, including excessive     sleepiness during the day. This is probably due to degeneration of sleep-regulating areas in     the brain. At present, the only treatment for sleepiness in PD is modafinil, which is     expensive and only partially effective. There is another potential treatment for sleepiness     that is used worldwide, is inexpensive, well tolerated and safe - namely, caffeine. There     have also been suggestions that caffeine may slow the progression of degeneration in PD,     since coffee non-drinkers are at higher risk of developing PD. PD patients, even with severe     sleepiness often do not use caffeine. It is unclear whether this is because their PD makes     their sleepiness unresponsive to caffeine, because they cannot tolerate it, or whether this     reflects their lifelong habit of non-use. This proposal outlines a trial in which patients     with excessive sleepiness will be given caffeine or placebo (no therapy) in a blinded     fashion. In this way, the effect of caffeine on sleepiness and motor symptoms can be directly     analyzed. In addition, these findings can be used to test the tolerability of caffeine, to     help plan a larger-scale study testing whether caffeine can slow the progression of PD   "
199608|NCT00459433|"     Complicated and expensive interventions are used to treat unspecific low back pain and the     intervention is not always targeted the patients specific problems.It is therefore not     surprising that a large fraction of unspecific low back pain patients do not respond very     well to the usual biopsychosocial intervention.      We would therefore like to identify the patients specific problems regarding the patients     biomedical, psychological, and social needs.   "
199622|NCT00459615|"     The purpose of this study is to compare four regimens using US FDA GMP intravenous artesunate     for the treatment of uncomplicated Plasmodium falciparum malaria to identify the most     effective treatment regimen as determined by rapidity of parasite clearance by microscopy.   "
199623|NCT00459628|"     Tomotherapy is a new radiation therapy system that uses an integrated CT scanner during     delivery of radiation treatment to improve the accuracy of the treatment. Furthermore the     irradiation is delivered helicoidally allowing highly conformal shaping of dose distribution.     However the magnitude of the clinical advantage of using the system in breast cancer is     unknown. The purpose of the present study is to investigate whether or not the Tomotherapy     can substantially reduce pulmonary and cardiac toxicities, as compared with conventional     radiotherapy.   "
199609|NCT00459446|"     This study will test how well a new contrast agent (dye) used in magnetic resonance imaging     (MRI) can help visualize totally blocked arteries that normally supply blood to the neck,     arms or legs. Currently used agents work well in visualizing normal or partly blocked     arteries (arteries that have some blood flowing through them), but only poorly in totally     blocked arteries. This study will see if a contrast agent called gadofosveset can better     brighten images of completely blocked arteries. Gadofosveset is approved in Europe for use in     MRI scans, but is still considered experimental in the United States.      People 18 years of age or older with known or suspected total blockage of an artery to the     neck, arm or leg may be eligible for this study.      Participants undergo MRI scanning with gadofosveset contrast dye. MRI uses a magnetic field     and radio waves to produce images of body tissues and organs. For this procedure, the subject     lies on a table that can slide in and out of the tubular scanner, wearing earplugs to muffle     loud noises that occur during the scanning process. The procedure lasts about 1.5 to 2 hours,     during which the subject may be asked to hold his or her breath several times for as long as     5 to 20 seconds. During the procedure, gadofosveset is injected and several kinds of MRI     pictures are taken to understand better how the new agent works. Subjects may be asked to     undergo a second scan using conventional MRI contrast dye   "
199610|NCT00459459|"     The purpose of this study is to investigate the relationship between prognosis and fine     needle aspiration cytology character of papillary thyroid cancer.   "
199611|NCT00459472|"     The purpose of this study is to compare outcomes of patients undergoing laparoscopic     cholecystectomy before and after a laparoscopic training curriculum was implemented.   "
199612|NCT00459485|"     This is a double-blind, randomized controlled trial conducted in men 19-65 years of age who     will receive daily zinc supplements (10 or 20 mg zinc/d as zinc sulfate) or placebo for 21     days. Blood samples for plasma zinc and CRP concentrations will be drawn at baseline and days     1, 2, 5, 9, 14, and 21 during supplementation and days 1, 2, 5, 9, and 14 after     discontinuation of supplementation.   "
199613|NCT00459498|"     The uptake of iodide by thyroid cells requires the expression of sodium iodide symporter     (NIS). Thyroid benign and malignant tumors have low iodide uptake activity. Previous studies     of NIS expression with RT-PCR and immunohistochemistry showed divergent data. NIS protein was     overexpressed in thyroid cancer. The aim of this study was to investigate the NIS transcript     levels and its presence and localization in 30 samples of thyroid tumors (14 benign and 16     malignant) and in their surrounding non-tumoral tissues (NT), by real time RT-PCR and     immunohistochemistry, respectively. Our results revealed lower gene expression in 78.6% of     the benign tumors and 100% of the carcinomas when compared with the NT samples, using GHPDH     as a housekeeping gene. Immunohistochemical staining revealed presence of NIS protein in 100%     of the non-tumoral samples, 100% of the benign tumors and 93.75% of the malignant tumors. NIS     protein was identified at basolateral membrane in 23.3% of non-tumoral samples, 14.3% of     benign and 12.5% of malignant tumors. Stronger cytoplasmatic immunostaining of NIS protein     was detected in 64.3% of benign tumors and in 87.5% of malignant tumors when compared to NT.     Association between low gene expression and strong cytoplasmatic immunostaining was found in     50% of benign tumors and 87.5% of malignant tumors. We concluded that the reduced NIS gene     expression in thyroid tumors associated with strong intracytoplasmatic staining may be due to     its incapacity to migrate to cellular membrane.   "
199614|NCT00459511|"     Hyperglycemia is frequent manifestations of the human metabolic response to systemic     inflammatory response syndrome (SIRS),sepsis and septic shock, and are implicated in the     clinical outcome.      Adrenomedullin is elevated in SIRS, sepsis and septic shock and has been demonstrated the     inhibitory role on insulin and adrenocorticotropic hormone secretion.      Our hypothesis is that: AM elevation after SIRS could be the responsible to maintain     hyperglycemia   "
199615|NCT00459524|"     Primary Objectives:        -  To compare the neuropsychiatric (NP) and neurocognitive (NC) symptoms and assess the          quality of life (QOL) in older patients (age > 18) with acute myelogenous leukemia (AML)          or high-risk myelodysplastic syndrome (MDS) receiving different therapies, chemotherapy          (Clofarabine + ara-C) or targeted therapies (PKC412 + low-dose ara-C, or R115777 +          low-dose ara-C, or decitabine, or STI + low-dose ara-C).        -  To determine whether there is a correlation between the number of packed red blood cell          (PRBC) transfusions and cognitive scores and/or QOL.   "
199616|NCT00459537|"     This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine     hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in     patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48     weeks.   "
199617|NCT00459550|"     A study to investigate the safety and tolerability of both single and multiple intravenous     administration of GSK933776 in patients with Alzheimer's Disease.   "
199618|NCT00459563|"     Vitamin D is a natural nutrient in normal daily diet. It can also be made in the skin after     exposure to sunlight and is essential for maintaining normal calcium balance. One past study     has suggested that vitamin D may be helpful for blood pressure. This study will test whether     pills containing cholecalciferol (a form of vitamin D) or calcitriol (the active form of     vitamin D) can treat high blood pressure. The investigators plan to enroll up to 80 subjects     at the Atlanta VA Medical Center. Participation in the study is expected to last up to 4     weeks. Subjects will be assigned to cholecalciferol, calcitriol or placebo). A 24-hour blood     pressure monitor will be worn at the beginning and end of the study to determine blood     pressure changes. Renin, PTH, angiotensin-II, and aldosterone levels will also be measured at     the beginning and end of the study.   "
199619|NCT00459576|"     Infants will be enrolled in this study if they have never been diagnosed with asthma or     wheezing and have been diagnosed with atopic dermatitis or eczema. Infants with some types of     skin rashes are at high risk for developing asthma by 6 years of age. The purpose of this     study is to determine whether we can identify infants who will develop asthma.   "
199620|NCT00459589|"     Older patients with cancer are poorly treated or not treated at all. A previous study in the     south west of France (364 patients) showed that patients receiving chemotherapy had short     survival times which strongly depended on nutritional status. In this study, the researchers     would like to evaluate if individual dietician follow-up at each cycle of chemotherapy     increases survival of patients at risk of undernutrition.   "
199626|NCT00459667|"     The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study     the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and     will further investigate the safety and tolerability profile of interferon beta 1b 500µg     during longer-term treatment.   "
199627|NCT00459680|"     To determine the effect of acupuncture and laser acupuncture point treatment on hypertensive     subjects.   "
199628|NCT00459693|"     The purpose of this protocol is to measure a receptor in the brain using positron emission     tomography (PET) that is involved in inflammation.   "
199629|NCT00459706|"     The purpose of this study is to explore and compare the perceptions and satisfaction for two     different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept     Prefilled Syringe) in patients with rheumatoid arthritis (RA).   "
199630|NCT00459719|"     The patients about to undergo liver transplantation will be randomized to one of the     following two group:      Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3     months(12 weeks   "
199631|NCT00459732|"     The purpose of this study is to test whether zinc can improve bone health in young patients     with thalassemia.   "
199632|NCT00459745|"     This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study     with a 52-week open-label follow-up to evaluate the safety and efficacy of daily     administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of     both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia.     There will be an open-label, 8-week, Selection Phase prior to randomization in which all     patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if     the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm,     double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg     or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg).     The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which     all patients will receive Pravafen.      After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria     will be randomized on a 1:1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen     (the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the     completion of the 12-week double-blind phase of the study, all patients that haven't had     changes in their well being, will be allowed to roll-over into the 52-week, open-label,     follow-up portion of the study. During the 52 week, open label, Safety Phase of the study,     all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160     mg).      Patients will be evaluated at baseline and every three weeks thereafter throughout the     initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week,     open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks.      Participation in the study can be up to 72 weeks.   "
199633|NCT00459758|"     To determine if electrical stimulation on acupoints has any effect on hypertensive subjects.   "
199634|NCT00459771|"     Evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan vs placebo in     prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer     treated with trastuzumab.   "
199635|NCT00459784|"     The purpose of this study is to determine whether a specially developed Dementia Training     Program for duos of general practitioners and primary care nurses is able to increase the     number dementia diagnoses in elderly people living in the community and increase the     adherence to clinical dementia guidelines   "
199636|NCT00459797|"     Patients presenting for elective surgery requiring orotracheal intubation will be randomized     to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or     the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.   "
199637|NCT00459810|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Estradiol may kill prostate cancer cells that no longer respond to hormone therapy.     Giving paclitaxel poliglumex together with estradiol may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with     estradiol works in treating patients with stage IV prostate cancer.   "
199638|NCT00459823|"     Two-centre, open-label, non-randomized, dose-finding phase I study to determine the MTD of     E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every     28 days in patients with solid tumors, for whom therapy of proven efficacy does not exist or     is not longer effective.   "
199639|NCT00459836|"     RATIONALE: Drugs used in chemotherapy, such as PR-104, docetaxel, and gemcitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given     together with docetaxel or gemcitabine in treating patients with solid tumors.   "
199640|NCT00459849|"     Plaque radiotherapy is a common treatment for uveal melanoma. However, local failure has been     reported in up to 20% of patients. We use intraoperative ultrasonography at plaque insertion     and removal to evaluate plaque movement as a potential factor in local failure.   "
199641|NCT00459862|"     This phase II trial is studying the side effects and how well pazopanib works in treating     patients with malignant pleural mesothelioma. Pazopanib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
199642|NCT00459875|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with     locally recurrent or metastatic kidney cancer.   "
199643|NCT00459888|"     In 5 Belgian hospitals, the data of 100 CLI-patients receiving the cryoplasty technique to     treat their infrapopliteal arterial lesions will be collected. The treatment occurs strictly     according the Instructions For Use of the CE-approved device (PolarCath Peripheral     Dilatation System, Boston Scientific) and only data are collected that have been made     available conform the Standard the Standards of Care for these patients.   "
199644|NCT00459901|"     To document the antitumor activity of capecitabine in combination with erlotinib in patients     with previously untreated metastatic colorectal cancer. Time to tumor progression, objective     response rate, time to confirmed response rate, duration of confirmed response rate, time to     treatment failure, and CEA response will be assessed.   "
199645|NCT00459914|"     A small number of uncontrolled studies have shown a high prevalence of sleep apnea in     patients with refractory hypertension and that CPAP treatment achieves a significant     reduction of blood pressure in the short term.      The purpose of this study is to assess the prevalence of sleep apnea in patients with     refractory hypertension, and the effects of continuous positive pressure treatment on     systemic blood pressure and on serum markers of endothelial dysfunction and angiogenesis.   "
199646|NCT00459927|"     The purpose of this study is to evaluate a new method of hemostasis, floseal gel, in     tonsillectomy and adenoidectomy, with the goal of decreasing post operative and     intraoperative morbidity.   "
199647|NCT00459940|"     In the present double blind, placebo-controlled, parallel study we evaluated the impact of 12     weeks thiazolidinedione (TZD) administration on basal and insulin-stimulated substrate     metabolism in growth hormone-replaced adults with growth hormone deficiency.   "
199648|NCT00459953|"     This study is designed to test the efficacy of an extended smoking cessation program for teen     smokers. We hypothesize that teen smokers randomized to extended treatment will have a higher     abstinence rate at 52 week follow-up than teen smokers receiving only open label treatment.   "
199649|NCT00459966|"     Aim: The aim is to evaluate the outcome after spine surgery when using an integrated program     that combined preoperative prevention and early postoperative rehabilitation compared to the     routine procedures.      Outcome measurements: Postoperative hospital stay, complications, function, pain, and patient     satisfaction.      Method: 60 patients scheduled for surgery for degenerative lumbar disease. The control group     followed the routines in the department. The intervention group followed the integrated     program consisting of preoperative prevention.   "
199650|NCT00459979|"     RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor     and by blocking some of the enzymes needed for cell growth.      PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in     treating patients with kidney cancer that cannot be removed by surgery.   "
199651|NCT00459992|"     This study will evaluate the effects of a drug called betahistine on appetite and food intake     in overweight women. Betahistine has been used for many years to treat vertigo (dizziness).     It was taken off the market in the United States in 1970 because it was thought to be     ineffective for vertigo, but is still used for this purpose in many other countries. Some     research suggests that betahistine may reduce appetite and food intake.      Healthy overweight women between 18 and 50 years of age may be eligible for this study.     Candidates must have a body mass index (BMI) between 30 and 40 and weigh less than 300     pounds. They are screened with a medical history and physical examination, blood and urine     tests, electrocardiogram (EKG), breathing test and eating behavior questionnaires.      Participants are admitted to the NIH Clinical Center for a 3-day/2-night stay for the     following procedures:        -  Medication: Subjects take either betahistine (in one of three possible doses) or placebo          capsules one time on the days of admission to the Clinical Center (day 1), three times          on day 2 and two times on day 3.        -  Blood tests and 24-hour urine collection.        -  Resting metabolic rate: Subjects rest quietly for 1 hour after awakening and then rest          again under a clear plastic hood or while wearing a face mask, breathing normally for          about 25 minutes.        -  DEXA scan to measure body fat, muscle, and bone mineral content: Subjects lie on a table          above a source of X-rays while a very small dose of X-rays is passed through the body.        -  Meal studies: Subjects food intake is measured on days 2 and 3.        -  Questionnaires: Subjects complete questionnaires about how hungry or full they are          feeling and rate how much they liked the foods they ate.   "
199652|NCT00460005|"     Understanding the speed at which migraine headaches develop is of importance to patients.     Determining the proportions in which different headache pain build-up occurs, may provide     health care practitioners with valuable information with which to prescribe the most     appropriate treatment. Patients who experience a slow pain build-up may gain more benefit     from medications which have a slow onset of effect, high tolerability and long action.     Conversely, medications with a rapid onset of effect may be of greater benefit to patients     who experience rapid onset of migraine pain.   "
199653|NCT00460018|"     The primary aim of this study is to evaluate whether a lifestyle intervention of diet,     exercise, and breastfeeding is associated with decreased postpartum weight retention and     reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with     gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma     insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and     breastfeeding duration.   "
199654|NCT00460031|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as     ketoconazole, may stop the adrenal glands from making androgens. Lenalidomide may stop the     growth of prostate cancer by blocking blood flow to the tumor. Giving ketoconazole and     hydrocortisone together with lenalidomide may be an effective treatment for prostate cancer.      PURPOSE: This phase II trial is studying how well giving ketoconazole and hydrocortisone     together with lenalidomide works in treating patients with prostate cancer that did not     respond to hormone therapy.   "
199655|NCT00460044|"     The purpose of this study is to study the relation between mechanical ventilation and ADMA     concentrations at birth.   "
199656|NCT00460057|"     High bone turnover with the bone resorption exceeding bone formation is a major mechanism of     postmenopausal osteoporosis. Therefore, inhibition of bone resorption is a rational approach     for the prevention. The Objective of the current study was to determine the short-term     efficacy of once-weekly low dose alendronate in the prevention of bone loss in early     postmenopausal Korean women with moderate bone loss via bone turnover markers.      This study was a 12-week, randomized, double-blind clinical trial compared the effects of     placebo with alendronate 20 mg once weekly. All subjects received supplemental calcium 600 mg     and vitamin D 400 IU daily. Fifty two postmenopausal women (the ages between 50-65 year) with     lumbar spine BMD at least 2.0 SD below the peak young adult mean were recruited at Eulji     University Hospital, Daejeon, Korea. BMD was measured by DXA at baseline and serum alkaline     phosphatase, osteocalcin and C-terminal telopeptide of type I collagen was measured at     baseline and 12 weeks after treatment.   "
199657|NCT00460070|"     Some antiepileptic drugs are found to have hormonal side effects. We want to study possible     hormonal side effects of the relatively new antiepileptic drug; levetiracetam and compare it     to the older drugs; lamotrigine and carbamazepine. The participants are going to fill in a     questionnaire and we will collect blood samples from them, to analyse hormones.   "
199670|NCT00460239|"     This is a residential study that looks at the effects of buprenorphine in persons who abuse     but are not dependent on opioids. Animal studies show that very high doses of buprenorphine     produce less effects than mid-range doses. This suggests that buprenorphine can be a very     safe medication. However, no studies in humans have tested higher doses in a similar way. The     goal of this study is to show the effects of single doses of buprenorphine, across a range of     doses, in persons who are not physically dependent on opioids (but do abuse opioids).   "
199658|NCT00460083|"     Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide     two- to threefold over the last 50 years. Epiceram, a newly FDA-approved medical device is a     topical barrier repair cream designed to deliver special epidermal lipids to the top layers     of the skin in order to correct skin barrier abnormalities found in atopic dermatitis.     Epiceram does not contain corticosteroids or other conventional anti-inflammatory components     and represents a novel class of skin barrier repair therapy for inflammatory skin disease.      The objective of this study is to determine whether Epiceram is a safe and effective therapy     for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel     therapy.   "
199659|NCT00460096|"     The primary purpose of this Phase II/III study is to demonstrate that Kamada-API, a new API     concentrate manufactured by Kamada Ltd., is comparable to a currently marketed API product.   "
199660|NCT00460109|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Combinations of biological     substances in denileukin diftitox may be able to carry cancer-killing substances directly to     cancer cells. Giving rituximab together with denileukin diftitox may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with denileukin     diftitox works in treating patients with previously untreated stage III or stage IV     follicular B-cell non-Hodgkin's lymphoma.   "
199661|NCT00460122|"     This study will determine if transfusion of platelets containing HLA antibodies (certain     antibodies to white blood cells) are more likely to cause transfusion reactions than     transfusion of platelets that do not contain HLA antibodies.      People 18 years of age or older who donate platelets at the NIH Clinical Center may be     eligible for this study.      An extra tube of blood (about one teaspoon) is obtained from participating donors at the time     of their donation at the NIH Platelet Center. The blood plasma in the extra tube is tested     for HLA antibodies and antibodies to certain white blood cells called granulocytes. The     research sample is assigned a code number for identification and sent to the HLA Laboratory     in the Department of Transfusion Medicine.   "
199662|NCT00460135|"     Impact of resistance training in prepubertal children with obesity focusing mostly in changes     in body composition and markers of insulin resistance.      Hypothesis is that this will show positive changes in this randomized controlled trial.   "
199663|NCT00460148|"     This study in PD patients is designed to assess the affect food has on the absorption,     distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted     state and other patients following a high-fat breakfast), and to assess the difference in     absorption, distribution, metabolism and excretion of ropinirole if patients are given three     4mg ropinirole tablets versus one 12mg tablet.   "
199664|NCT00460161|"     Phantom pain is a common complication following limb amputation, and is thought to result     from a system of pathophysiological mechanisms - peripheral, spinal, central and     psychological. Treatment is primarily medical, using antidepressant and anticonvulsant     medications. At present, there is no evidence-based approach for the management of phantom     limb pain (PLP). Acupuncture is an ancient Chinese treatment during which thin needles     (diameter 0.20-0.30mm) are inserted into various points on the skin. Studies of this     treatment have found significant benefit in a number of conditions with chronic pain.      We propose a randomized, double-blind, placebo/sham -controlled study to evaluate whether     acupuncture is an effective and safe modality for preventing and reducing PLP in patients     following lower limb amputation. Patients requiring lower limb amputation (above-ankle) will     be randomized into two groups, for real or placebo/sham acupuncture treatment. Both groups     will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture     treatment protocol, using either true or placebo needles at sham acupuncture points, for a     period of four weeks (eight treatments).      The primary outcome to be evaluated will be PLP at 4 weeks, using a site-specific numerical     rating pain scale (ss-NRS). Secondary outcome measures to be evaluated are: stump pain     (ss-NRS); analgesic use (Tramadol, 100mg Tablet); and depressive symptoms, using the Beck     Depression Score. Blinding of the participants will be evaluated using a Validation of     Blinding Questionnaire at the end of the treatment period.   "
199665|NCT00460174|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Bevacizumab may also stop the tumor growth by     blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor     cells. Gemcitabine and bevacizumab may make tumor cells more sensitive to radiation therapy.     Giving gemcitabine together with bevacizumab and radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with     bevacizumab and abdominal radiation therapy works in treating patients with localized     pancreatic cancer.   "
199666|NCT00460187|"     Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of     the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during     carotid artery percutaneous intervention in high surgical risk patients.   "
199667|NCT00460200|"     RATIONALE: Measuring levels of interleukin-6 and depression may help doctors understand the     relationship between interleukin-6 and depression. It may also help the study of cancer in     the future.      PURPOSE: This clinical trial is studying depression and interleukin-6 production in patients     with ovarian epithelial cancer.   "
199668|NCT00460213|"     The purpose of this study is to compare improvement percentage of urinary albumin excretion     between valsartan 80 mg- and valsartan 160 mg-based therapy in patient with morning     hypertension.   "
199669|NCT00460226|"     This is multi-center, prospective, observational stud. This study is designed to evaluate the     rate of non-serious rash in Korean bipolar I patients.   "
199737|NCT00461123|"     The greenlight laser has an absorption maximum which is exactly the same as for hemoglobin.     In the presence of hemoglobin, its application causes vaporization of the tissue and this     effect depends on the concentration of hemoglobin in the respective tissue. Therefore,     increase of blood-flow in the tissue (here: prostate gland) should exert better efficacy of     the laser application and consequently shortening of the required duration of laser     application.   "
199671|NCT00460252|"     This is an open mono-centre randomised controlled trial performed at the Medical University     Graz including a treatment visit (V1). In the treatment visit (V1) after admittance to the     ICU arterial blood glucose values will be monitored and either the software-algorithm eMPC     will be used to adjust the infusion rate of intravenously administered human soluble insulin     to normalise arterial blood glucose or routine treatment will be used to establish tight     glycaemic control. The treatment visit will last for 72 hours.      The primary hypothesis of the study is that blood glucose control by the eMPC algorithm is     not inferior compared to the implemented routine protocol.   "
199672|NCT00460265|"     The purpose of this study is to determine the treatment effect of Panitumumab in combination     with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or     recurrent squamous cell carcinoma of the head and neck.   "
199673|NCT00460278|"     The purpose of this study is to evaluate the safety and tolerability of XL418 in subjects     with solid tumors. XL418 is a new chemical entity that inhibits a spectrum of targets,     including Akt and p70S6K, that mediate PI3 Kinase / PTEN signaling.   "
199674|NCT00460291|"     If patients need to undergo bypass surgery, either an autologous vein can be used as bypass     or, if there are no suitable veins are available, a prosthetic graft can be implanted.     Varicose veins normally are judged not to be suitable as bypass. The ProVena vein support,     made from polyester, is considered to strengthen varicose veins so that they they become     suitable as bypass. Thereby, the advantages of an autologous bypass and the stability of     polyester material can be combined.      Patients that take part in the trial recieve an autologus bypass with a varicose vein, coated     with ProVena. They are followed up at 3 and 6 months after implantation of a ProVena-coated     bypass via duplex-sonography to assess the graft patency.   "
199675|NCT00460304|"     The primary objective is to establish the mean percentage of change in the     insulin-to-carbohydrate ratio due to pramlintide treatment once a maximum tolerated dose or 6     mcg before each meal is reached. The secondary objective is to establish which insulin bolus     wave form is associated with the lowest post-bolus without hypoglycemia in subjects treated     with maximum pramlintide dosage.   "
199676|NCT00460317|"     To determine if treatment with AMG 706 (motesanib diphosphate) in combination with paclitaxel     and carboplatin improves overall survival compared to treatment with placebo in combination     with paclitaxel and carboplatin in subjects with advanced non-squamous NSCLC and in subjects     with adenocarcinoma histology (adenocarcinoma subpopulation).   "
199677|NCT00460330|"     The purpose of this study is to assess the cut-off value of GM/G test in Chinese patients     after hematopoietic stem cell transplantation, and evaluate GM/G test and real-time PCR for     diagnosis of IFI in Chinese patients.   "
199678|NCT00460343|"     The purpose of this study is to determine the effectiveness of maximal support of community     pharmacies to implement a pharmaceutical care model for establishing and - if necessary -     improving adherence to antihypertensive medication in patients with medication-resistant     hypertension.   "
199679|NCT00460356|"     This clinical trial studies glycoprotein and glycan in tissue and blood samples of patients     with stage IB-IVA cervical cancer undergoing surgery to remove pelvic and abdominal lymph     nodes. Studying samples of tumor tissue and blood from patients with cancer in the laboratory     may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and     identify biomarkers related to cancer. It may also help doctors learn how far the disease has     spread.   "
199680|NCT00460369|"     Malaria is a life-threatening disease especially in small children. A high degree of     Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this     study is taking place. In the past few years, the recommendation for a first-line treatment     in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing     evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the     study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT):     artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be     unsupervised.      The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary     outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the     relationships between ACT PK data (day 3) and outcome.      Expected total enrollment: 225 patients      Study start: April 2007; expected completion: December 2007   "
199681|NCT00460382|"     The purpose of this study is to look at the safety and efficacy of a combination of 3 new     antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have     multi-resistant viruses and limited treatment options. An optimized background regimen that     may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added,     if possible, to this combination. Patients will undergo treatment for 48 weeks and     virological efficacy will be evaluated at week 24.   "
199682|NCT00460395|"     Study Objectives:        -  To compare the survival (overall, systemic, and neurological) of patients with single          cerebral metastases treated with either conventional surgical resection or stereotactic          radiosurgery.        -  To compare their rates of recurrence, complications, and their cognitive ability,          functional status, and quality of life.      Although surgical resection is a proven and effective treatment for brain metastases in     patients with systemic cancer, stereotactic radiosurgery has been suggested to be equally     effective and less morbid. Nonrandomized retrospective comparisons have been unable to     resolve whether stereotactic radiosurgery is as effective as conventional surgery because of     the complexity and variability of the population of patients with cancer and brain     metastases. This controversy can only be resolved by a prospective randomized trial comparing     these treatment modalities. Patients not randomized will be analyzed as a separate group.   "
199683|NCT00460408|"     The study will provide additional safety data for specific safety events in persons receiving     intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is     interested in obtaining additional safety information when Macugen is used in real world     settings by practitioners in Europe treating patients with neovascular (wet) age-related     macular degeneration (AMD). The study will provide information about physician practice     patterns and characteristics of patients treated with Macugen.   "
199738|NCT00461136|"     This study will evaluate the time-course of the antiproteinuric effect of renin inhibition     with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established     nephropathy.   "
199684|NCT00460421|"     20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias     receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body     irradiation [TBI]) followed by hematopoietic stem cell transplant (HSCT). The study will     evaluate the safety and pharmacokinetics of palifermin in pediatric patients. Three doses (40     μg/kg/day, 60 μg/kg/day, and 80 μg/kg/day) are to be evaluated in each age group (1 to 2, 3     to 11, and 12 to 16 years, respectively) using a conventional dose escalation design.     Palifermin is administered for 3 consecutive days (Day -10 to Day -8, respectively) before     the start of the conditioning regimen and for 3 consecutive days (Day 0 to Day +2) following     HSCT. Patients will be enrolled simultaneously to each age group to identify a safe, well     tolerated, efficacious dose in each age group. Patients will also be followed for secondary     malignancies, progression-free survival (PFS) and overall survival (OS)   "
199685|NCT00460434|"     Pelvic organ prolapse is common among women with a prevalence that has been estimated to be     as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal     incision. Some women develop stress urinary incontinence after surgery. A prior randomized     trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy     decreases the risk of urinary incontinence; however, the benefit of adding an anti     incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal     approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse repair     and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment with     Tension-free Vaginal Tape (TVT) at the time of prolapse surgery done via a vaginal approach     is effective in preventing urinary incontinence.   "
199686|NCT00460447|"     Study Design:      prospective phase II trial with 30 patients in 1 site      Treatment Scheme:      Option 1: Patient < 60 years of age with relapse after chemotherapy or > 12 months after     hematopoetic stem cell transplantation Mylotarg 6 mg/ m² day –21 Mylotarg 3 mg/ m² day –14     Fludarabin 30 mg/ m² day –6 to –3 TBI 2x2 Gy day –3 to –2 (total dose 8 Gy) Tacrolimus (level     adapted) from day –3 on Mycophenolat 2 x 1000 mg p.o. from day 0 to day 40 PBSC day 0      Option 2: Patient > 60 years of age or younger patients < 12 Months after hematopoetic stem     cell transplantation Mylotarg 6 mg/ m² day –21 Mylotarg 3 mg/ m² day –14 Fludarabin 30 mg/ m²     day –3 to –1 TBI 1x2 Gy day 0 (total dose 2 Gy) Tacrolimus (level adapted) from day –3 on     Mycophenolat 2 x 1000 mg p.o. from day 0 to 40 PBSC day 0   "
199687|NCT00460460|"     The primary purpose of this study is to find out what the maximum tolerated dose is for an     experimental drug called AZD4877 based on the side effects experienced by patients that     receive AZD4877 on a weekly basis in these diseases.   "
199688|NCT00460473|"     The purpose of this study is to evaluate the efficacy and safety of perioperative use of     dexmedetomidine in the prevention of postoperative delirium in subjects undergoing surgery     for fractured hip with general anesthesia.   "
199689|NCT00460486|"     The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5     ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and     second vaccinations being administered according to a rapid immunization schedule (12 ± 2     days apart). The third vaccination will be administered approximately 6 months after the     first dose.   "
199690|NCT00460499|"     This study seeks to determine whether varying the dose of insulin and glucose in diabetic     patients during coronary bypass surgery will improve outcomes in these patients.   "
199691|NCT00460512|"     The purpose of this study is to explore tolerability, safety and effectiveness of flexibly     dosed paliperidone extended release (ER) in participants with schizophrenia (psychiatric     disorder with symptoms of emotional instability, detachment from reality, often with     delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated     with an oral antipsychotic medication.   "
199692|NCT00460525|"     Malaria is a disease that affects many people in Africa. Malaria is caused by germs spread by     mosquito bites. The purpose of this study is to compare the number of children who get     malaria after receiving an experimental malaria vaccine (FMP2.1/AS02A) to the number of     children who get malaria after receiving a vaccine for rabies (an approved vaccine that does     not prevent malaria). The children will be assigned to one of the vaccine groups by chance.     Participants and doctors will not know which vaccine was given. Study participants will     include 400 children, ages 1-6 years, living in Bandiagara, Mali. Children will receive 3     vaccine doses, by injection, to their upper arm. Study procedures will include physical exams     and several blood samples. Participants will be involved in the study for 26 months.   "
199693|NCT00460538|"     The purpose of the study is to determine weather Lectranal is effective in treatment of     seasonal allergic rhinitis symptoms.   "
199694|NCT00460551|"     The purpose of the study is to investigate if treatment with zalutumumab in combination with     chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients     with lung cancer compared to patients treated with chemo-radiation alone.   "
199695|NCT00460564|"     This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over     placebo in patients with post-stroke upper limb spasticity of both the wrist and finger     flexors using the Modified Ashworth Scale (MAS) wrist score.   "
199696|NCT00460577|"     To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide     plus Fenoterol in cumulative sequential doses in asthmatic children (5-<12 years) with acute     bronchial obstruction attending emergency services   "
199697|NCT00460590|"     This study is designed to evaluate the safety of MVA85A in healthy volunteers in Cape Town.     We have shown that MVA85A is safe and immunogenic in both a mycobacterially naïve population     in the UK and in a more mycobacterially exposed population in The Gambia. The studies     described here will be to assess the safety of MVA85A in 2 groups of adults, those with and     without prior BCG vaccination. Once safety data has been obtained in these 2 groups, we will     assess the safety of MVA85A in adolescents who have been previously vaccinated with BCG.   "
199698|NCT00460603|"     To determine the safety and efficacy of AG-013736 in combination with other standard of care     medication in patients with first line metastatic colorectal cancer.   "
199762|NCT00461292|"     The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A     in treating overactive bladder in spinal cord injury or multiple sclerosis patients   "
199699|NCT00460616|"     Dopamine agonists are first-line agents for the treatment of prolactinomas (1) and     Parkinson's disease (2). There is evidence supporting a causal relationship between the     occurrence of drug-induced restrictive valvular heart disease and treatment with pergolide     (3): in several cases, the valvulopathy improved when pergolide was discontinued (4).     Valvular heart damage has also been reported with the ergot-derived dopamine agonists     bromocriptine and cabergoline (5,6).      Two recent studies (7,8) have further demonstrated that both pergolide and cabergoline are     associated with an increased risk of new cardiac valve regurgitation in patients treated for     Parkinson's disease.      The valvular abnormalities seen with ergot-derived dopamine agonists are similar to those     observed in patients receiving ergot alkaloid agents (such as ergotamine and methysergide) in     the treatment of migraine, or fenfluramine and dexfenfluramine in the treatment of obesity.     These abnormalities also closely resemble carcinoid-related valvulopathies (9).      Cardiac valve disease has never been reported in patients with prolactinomas who require     treatment with dopamine-agonists even life-long (1). At variance with patients with     Parkinson's disease, patients with prolactinomas are younger and are treated with an average     dose of dopamine-agonists that is significantly lower (median bromocriptine dose 5 mg/day and     median cabergoline dose 1 mg/week). Because of the young age of treatment beginning (most     patients with microprolactinomas start dopamine-agonist treatment in early adulthood),     treatment might be continued for over 3 decades: the cumulative risk of low doses of dopamine     agonists for such a long period of treatment is currently unknown.      To assess the prevalence of cardiac valve disease in patients treated with cabergoline, we     wish to perform an echocardiography screening in a large representative sample of patients     with prolactinoma who were treated with cabergoline for at least 12 months and in a group of     control subjects recruited prospectively. We wish to evaluate the severity of regurgitation     for the mitral, aortic, and tricuspid valves. Changes in cardiac valve apparatus was compared     with treatment duration and cumulative cabergoline dose.   "
199700|NCT00460629|"     Efforts to decrease the risk of GvHD by depleting T cells from the graft in CML patients have     been complicated by an increased incidence of leukemia-relapse. Newer protocols using CD34+     selected hematopoietic cells from matched-sibling donors and subsequent infusion of T cells     in incremental doses to treat or avoid relapse of disease seem to be more promising. In this     study, we try to further optimize this approach by the prophylactic infusion of cytotoxic T     cells activated ex-vivo against leukemia-associated/specific antigens using peptide-pulsed     dendritic cells.   "
199701|NCT00460642|"     26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers     (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical     protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap     Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD     Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation with     ART treatment, and its usage decreases significantly the number of injections that the     patient receives with treatment. The working hypothesis for this study is that the GnRH     antagonist (Cetrotide) can be used instead of an agonist to achieve effective down regulation     in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron because of the     markedly fewer injections required.   "
199702|NCT00460655|"     This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with     equinus deformity associated with post-stroke lower limb spasticity using the Modified     Ashworth Scale (MAS) ankle score.   "
199703|NCT00460668|"     The purpose of this study is to evaluate the effects of an integrated multidisciplinary     rehabilitation program on health related quality of life in the 12 months postoperative     period in patients with an elective thoracotomy and to evaluate the effects of the program on     general quality of life (SF-36), acute/chronic post-thoracotomy pain, impairment (changes in     pulmonary function), disability (exercise capacity) and start to complete recovery (ECOG     score of 0 or 1) 12 months postoperatively in patients with an elective thoracotomy.   "
199704|NCT00460681|"     The purpose of this study is to evaluate the clinical efficacy of thymopentin on the     prevention of the recurrence and metastasis of small HCC after resection.   "
199705|NCT00460694|"     Cytokine-induced killer ( CIK ) cells have been shown by our lab to be cytolytic against both     autologous and allogeneic acute myeloid leukemia ( AML ) cells. Large scale expansion of CIK     cells has also been shown to be feasible in healthy allogeneic stem cell donors as well as in     patients undergoing mobilization for autologous transplant.      Donor lymphocyte infusion (DLI) has been shown to be active against some haematological     malignancies including CML, AML, MDS,NHL and Hodgkin's disease. These donor lymphocytes can     be further activated in vitro to become CIK cells. At least 2 other centers in the world have     given allogeneic CIK cells for patients relapsing post allogeneic transplant for a variety of     haematological malignancies. These early reports have demonstrated feasibility, absence of     increased GVHD and possible efficacy in some cases.      We are proposing a Phase I /II study on the feasibility / efficacy of immunotherapy with     allogeneic CIK cells for patients who relapse after allogeneic marrow transplant for their     haematological malignancies. These patients have to be either refractory to conventional     donor lymphocyte infusion, or need a larger number of donor lymphocyte than could be provided     by unmanipulated donor lymphocytes. Donor lymphocytes will be collected and cultured in GMP     facilities to maturity, then infused into patients. This will be given in graded doses at 4     weekly intervals and continued on in the absence of GVHD till remission is achieved or     disease progression occurs. Patients may receive various forms of chemotherapy appropriate to     the clinical condition in each case before the allogeneic CIK infusion.      Efficacy will be assessed by comparing the response to allogeneic CIK infusion vs that to due     to conventional DLI, ie response to the two different treatment using DLI response as the     comparator. We expect about 10 such cases to be done over the next 3 years. Significant     statistics is unlikely to be generated but observation and description of the response can     generate useful information for presence or not of the efficacy of such a treatment.      If clinical efficacy and superiority over conventional DLI is demonstrated, then future     allogeneic CIK may take the place of DLI in this group of poor prognosis patients who relapse     after allogeneic transplant .   "
199706|NCT00460707|"     Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to     test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy     human subjects.   "
199707|NCT00460720|"     The survey is designed to identify non-compliant Attention Deficit Hyperactivity Disorder     (ADHD) patients who are currently on Immediate- Released Methylphenidate (IR-MPH) and observe     any change in compliance after treating with other drugs intended to treat ADHD for over 3     weeks   "
199708|NCT00460733|"     The purpose of this study is to evaluate the efficacy and safety of risedronate sodium     (Actonel®) after a wrist fracture in postmenopausal women.   "
199709|NCT00460746|"     The purpose of this study is to examine the safety, tolerability, and effectiveness of     darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside     Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by     darunavir/ritonavir and TMC125 in HIV positive patients who can no longer tolerate     enfuvirtide and are experiencing viral suppression. Other antiviral drugs in the regimen are     to remain unchanged.   "
199723|NCT00460941|"     This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different     doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose     of metformin. Patients will be randomized to receive either subcutaneous placebo, or     subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to     either 30mg or 40mg), weekly. All patients will continue on their existing metformin     treatment regimen throughout the study. The anticipated time on study treatment is <3 months,     and the target sample size is 100-500 individuals.   "
199710|NCT00460759|"     The purpose of this study is to determine the pharmacokinetics (how a drug is absorbed,     distributed, and eliminated by the body) of moxifloxacin alone versus moxifloxacin given with     rifapentine. Researchers believe that understanding how these tuberculosis drugs interact     when given together may help to determine the best drug treatment plan for use in future     studies. Volunteers will take moxifloxacin daily by mouth for the first part of the study and     then moxifloxacin in combination with rifapentine during the second part of the study.     Sixteen healthy men and women will be recruited from Johns Hopkins University School of     Medicine to volunteer for this study. They will be required to stay in the inpatient unit     twice, each time for 84 hours. Study procedures will include having a tube placed in a vein     to draw several blood samples over time. Volunteers will participate in the study for a     maximum of 48 days, including screening and follow-up visits.   "
199711|NCT00460785|"     The purpose of this study is to demonstrate bioequivalence of a new formulation to a     reference   "
199712|NCT00460798|"     This non-interventional study includes patients with advanced and/or metastatic renal cell     carcinoma who are treated with SUTENT and who did not receive any other systemic therapy     before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy     and tolerability under conditions of routine use of Sutent. The individual observation period     of each patient will be      1 year.   "
199713|NCT00460811|"     The purpose of this study is to determine the safety, efficacy, and dose response of a range     of oral doses of linaclotide administered to patients meeting criteria for IBS-C.   "
199714|NCT00460824|"     Transplant rejection following organ transplant occurs because the recipient's immune system     attacks the transplanted organ. The recipients immune system recognizes the transplanted     organ as foreign tissue and attempts to destroy it in the similar way that it attempts to     destroy infectious agents such as bacteria and viruses. The human leukocyte antigen (HLA)     system is a set of genes that is responsible for controlling an individuals' ability to tell     the difference between an infectious agent and self tissue.      Differences in HLA genes between donors and recipients play a major part in influencing the     rejection or acceptance of foreign tissue (i.e. transplanted organs). Due to time limitations     in heart transplantation, HLA matching is not considered. It is unclear how individual HLA     differences affect the recovery and expected lifespan of pediatric heart transplant     recipients.      This study is designed to look at the donor-recipient matching and mismatching to determine     if mismatching leads to more complications, shorter graft survival and, therefore, increased     risk of death following pediatric heart transplantation.   "
199715|NCT00460837|"     The study will compare patient's experience between those taking a standard bowel cleansing     regimen with minimal laxative tagging regimen of senna and gastrofin. Additionally comparing     any possible reduction in diagnostic accuracy that may ensue from an increased quantity of     retained faecal residue.   "
199716|NCT00460850|"     This single arm study will evaluate the efficacy and safety of PEGASYS in patients with     lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180     micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of     treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the     target sample size is <100 individuals.   "
199717|NCT00460863|"     The purpose of this study is to test a novel application of an existing treatment - using col     dialysate (often used to treat hypotension) as opposed to warm dialysate (standard treatment)     during hemodialysis for its ability to stabilize the sleep/wake cycle of patients receiving     this chronic treatment   "
199718|NCT00460876|"     This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of     periocular topotecan in patients with relapsed-resistant retinoblastoma.   "
199719|NCT00460889|"     This study is designed to look at outcomes of patients who have undergone hand assisted     laparoscopic donor nephrectomy versus totally laparoscopic donor nephrectomy.   "
199720|NCT00460902|"     Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of     medication resistant major depression. Stimulation is administered with and without     cognitive-emotional provocation.   "
199721|NCT00460915|"     Primary Objective -To investigate the clinical effectiveness of lacidipine and amlodipine on     systolic blood pressure (SBP) in Korean ISH patients aged 60 to 80 years.      Secondary Objectives -To investigate the clinical effectiveness of lacidipine and amlodipine     on diastolic blood pressure (DBP) in Korean ISH patients aged 60 to 80 years      To demonstrate the effectiveness of lacidipine and amlodipine on endothelial function through     measurement of markers of inflammation.   "
199722|NCT00460928|"     Neonatal lupus (NL) is the name given to a group of conditions that can affect the babies of     mothers who have certain autoantibodies against components of the body's cells that are     called SSA/Ro and SSB/La. NL can appear as a temporary rash that usually goes away by the     time the baby is 6 months old, or very rarely an abnormal blood or liver condition that also     improves with time - or it can cause permanent and often life-threatening damage to the fetal     heart, known as congenital heart block (CHB). In women with anti-Ro/La antibodies who are     pregnant for the first time, only about 2% of the babies will develop CHB. But for a woman     who has already had a child with CHB or NL rash, the risk of CHB in her next pregnancy is     nearly 20%. Unfortunately, once complete (third degree) heart block has been unequivocally     identified in a fetus, it has never been reversed with any of the therapies that have been     tried to date. Our previous studies strongly indicate that scarring of the conduction system     (the heart's own natural pacemaker), a consequence of inflammation triggered by the     mother's antibodies, damages or even destroys the cells that allow the heart to beat at a     normal rhythm. Instead, the damaged heart beats extremely slowly, to an extent that is fatal     to nearly 20% of affected babies (with most deaths occurring as fetal demises). Nearly all     surviving children with CHB require permanent implantation of a pacemaker device. Because it     is so difficult to treat or repair the damaged heart, a high-priority strategy is to try to     prevent the inflammatory process before irreversible scarring can occur. The aim of this     clinical-based proposal is to determine whether treating the pregnant mother with intravenous     immune globulin (IVIG) will prevent the development of CHB.   "
199724|NCT00460954|"     The purpose of this clinical research study is to determine if different dosage regimens of     Sinemet® CR (Carbidopa/levodopa) are dose proportional   "
199725|NCT00460967|"     SUMMARY      Age-related macular degeneration (AMD) is the leading cause of late onset visual impairment     and legal blindness in people 65 years of age or older in the United States. It is a     heterogeneous clinical entity in which retinal degeneration occurs predominantly in the     macula in the context of aging and leads to impairment primarily of central visual acuity.     The degenerative retinal eye disease occurs in two forms - a non-exudative dry form and an     exudative wet form which in an individual patient may also represent stages of the disease.     Non-exudative AMD accounts for 80-90% of AMD cases and it involves a constellation of     clinical features that can include drusen, pigment clumping and/or retinal pigment epithelium     (RPE) dropout, and geographic atrophy. Because of the overwhelming numbers of dry AMD     subjects, the cumulative impact of this vision loss is significant.      There is no effective therapy for maintaining or improving vision associated with dry AMD.     The only therapy for persons with dry AMD is an oral supplement containing high doses of     antioxidants and zinc, which was tested by the National Eye Institute in a large,     multi-center, double-masked, sham-controlled clinical trial1. This antioxidant therapy was     shown to modestly retard the progression of dry AMD from an intermediate stage to the     advanced stages and confirmed the benefit of antioxidant therapy in this disease. There is     currently no FDA-approved therapy for the treatment of subjects with dry AMD.      Recently, the MIRA-1 modified per protocol population showed the effectiveness of     Rheopheresis which is an application of selective therapeutic apheresis, namely double     filtration plasmapheresis (DFPP) using a specifically designed filter for plasma filtration     in subjects with non-exudative AMD. At one year the study reported with statistical     significance (1) approximately a one line vision improvement in the Rheopheresis group versus     no change in the Sham group and (2) 28% of subjects randomized to the active treatment     gaining at least one line vision versus only 9% of subjects randomized to the sham treatment.      With a total of 300 subjects with dry AMD and visual acuity of 20/40-20/100 inclusive, the     current investigation plans to prove the effectiveness of the Rheopheresis treatment on a     larger scale. Each subject will receive a series of 8 treatments (either active treatment or     sham treatment in a 2:1 ratio) for a period of approximately 2.5 months. In addition, a     post-treatment ophthalmic evaluation will be performed 2 weeks after the 8th treatment     (approximately 3 months after the baseline visit) and at the 6, 9 and 12 month visits.     Comparing the one-year proportions of at least a 10-letter gain in ETDRS LogMar BCVA from     baseline, the current investigation will show the effectiveness of Rheopheresis treatment     (compared to sham treatment) for treating dry AMD subjects. Other secondary effectiveness     endpoints, including mean changes and proportions of BCVA better than 20/40 at one year, will     be analyzed to support the main investigation.   "
199726|NCT00460980|"     This study proposes evaluation of an educational tool, a laparoscopic virtual reality     simulator. The purpose of this study is to determine whether training on the LapSim Simulator     transfers to improved laparoscopic cholecystectomy operative performance in an animal model.   "
199727|NCT00460993|"     The purpose of this study is to examine the effects of the sleep aid Lunesta (Eszopiclone),     on older adults who reside in a nursing home and have poor sleep as determined by wrist     actigraphy.   "
199728|NCT00461006|"     This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral     antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2     diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized     to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and     efficacy parameters will be assessed at intervals during the treatment period. The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
199729|NCT00461019|"     Congestive Heart Failure is the result of a number of diseases affecting the heart, causing     the heart's failure to properly meet the body demands for blood circulation. In spite of     advances in drug therapy, it remains a significant public health problem.      Pharmacologic antagonism of the beta-adrenergic receptors shifting the autonomic balance in     the direction of greater vagal influence is a well-proven treatment for heart failure     patients, although there are patients who cannot tolerate, or only partially benefit from     such a treatment.      It has been proven in the past and well established that parasympathetic nerve stimulation     can slow the rate of the heart and reduce the workload of the heart. Therefore, the potential     benefit of vagus nerve stimulation, hence parasympathetic activation, for treatment of heart     failure is substantial.      In this study, the safety and efficacy of a new vagus nerve stimulating system will be     evaluated. This study will compare whether the new device improves Heart Failure parameters     in Class II - III Heart Failure patients.   "
199730|NCT00461032|"     This study, in children with chronic asthma, evaluates the number of days of worsening asthma     during 8 weeks of treatment with montelukast after treatment is started for the first day of     school.   "
199731|NCT00461045|"     This is a Phase 1/2, open-label, multicenter study examining the safety, pharmacokinetics and     pharmacodynamics, and best overall response to escalating doses of the proteasome inhibitor     NPI-0052 in patients with relapsed or relapsed/refractory multiple myeloma. NPI-0052 is a     novel, second generation proteasome inhibitor that prevents the breakdown of proteins     involved in signal transduction which blocks growth and survival in cancer cells. The study     is divided into 2 parts: Part 1 is Phase 1 and explores 2 different schedules of NPI-0052 to     determine the maximum tolerated dose and/or recommended phase 2 dose (Schedules A [once     weekly dosing] and B [twice-weekly dosing]). Part 2 is Phase 2 and is a 2-stage efficacy     design in a selected subgroup of patients treated with Schedule B at the recommended phase 2     dose, as determined in Part 1. Amendment 13 to the protocol is currently recruiting to     evaluate the safety and any preliminary evidence of efficacy of NPI-0052 in multiple myeloma     patients who have previously received carfilzomib (PR-171, Kyprolis™) and subsequently had     disease progression. Patients in Part 2 will be followed for survival for up to 5 years from     date of first dose.   "
199732|NCT00461058|"     This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos     in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible     patients will be randomized to receive either aleglitazar, titrated to an individual maximum     tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated     dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
199733|NCT00461071|"     The purpose of this study is to evaluate the effectivity of guided self-help via Internet and     bibliotherapy in the treatment of bulimia nervosa (BN) in young women.   "
199734|NCT00461084|"     The purpose of this study is to see if a treatment with Biaxin (clarithromycin) which is an     antibiotic given by mouth for 3 months can delay the growth of your lymphoma or shrink the     lymphoma. We would also like to see how Biaxin (clarithromycin) works on lymphoma and blood     cells.There is some evidence that this medication may change the behavior of lymphocytes, in     addition to its known anti-infection activity.   "
199735|NCT00461097|"     The purpose of this study is to determine if oral immunotherapy (OIT) will desensitize a     child with an allergy to egg and eventually lead to the development of tolerance to egg.   "
199736|NCT00461110|"     The purpose of this study is to determine the maximum tolerated dose and assess the safety     and tolerability of escalating doses of BMS-663513 when given in combination with either     radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.   "
199739|NCT00461149|"     Epidemiological data indicate that patients with active acromegaly have reduced life     expectancy because of cardiovascular (60%) and respiratory diseases (25%) mainly (1-10). A     post-treatment GH value <5 mU/liter (equal to <2.5 μg/liter) and IGF-I in the normal range     for age are recognized as the most predictive survival indices.      Since their introduction into clinical use approximately two decades ago, somatostatin     analogs have been considered a cornerstone of medical therapy for acromegaly. After 12 months     of treatment with octreotide-LAR, control of GH and IGF-I excess, is achieved in 54% and 63%     of unselected patients (11). The proportion of subjects achieving IGF-I normalization     increases significantly with time (12). Significant tumor shrinkage has also been reported in     a number of studies (13,14): an average 50% tumor decrease is achieved when the drug is used     exclusively, or before surgery or radiotherapy (14). In 99 unselected newly diagnosed     patients after 12 months of treatment with somatostatin analogues we reported control of GH     levels in 57.6% and IGF-I levels in 45.5% and a greater than 50% tumor shrinkage in 44.4%     (15).      The dose of LAR in different studies ranged from 10-40 mg every 28 days (q28d): high doses     are generally administered in patients who do not control GH and IGF-I excess with lower     doses. As reported in the meta-analysis (11) the rate of IGF-I normalization tended to be     lower as octreotide-LAR dose was raised: 90% in patients treated with 10 mg, 61% with 20 mg     and 53% with 30 mg. However, some further benefit by increasing the dose of octreotide-LAR     was reported in some studies (16-18).      Data on dose escalation of octreotide-LAR given as first-line therapy in newly diagnosed     patients with acromegaly are lacking.   "
199740|NCT00461162|"     Chronic obstructive pulmonary disease, including emphysema and chronic bronchitis, is the     fourth most common cause of death and the second leading cause of disability in the United     States. COPD is estimated to be responsible for more than 13.4 million physician visits and     13% of hospitalizations nationally. These hospitalizations are usually caused by acute     exacerbations characterized by an increase in symptoms including dyspnea or shortness of     breath (SOB), cough, wheezing, and sputum production. The significant disability for people     with COPD is primarily due to the symptom of dyspnea (shortness of breath) that affects an     individual's quality of life more than does the physiological impairment. Despite optimal     medical and pharmacological therapy, most people with COPD continue to suffer from chronic     and progressive dyspnea and other symptoms of cough and fatigue.      We have previously shown that an individualized face-to-face dyspnea self-management program     was effective in improving dyspnea with activities of daily living (ADL), physical     functioning, and self-efficacy for managing dyspnea. Using an experimental longitudinal     design, the i-DSMP will be compared to the Face-to-Face Dyspnea Self-Management Program     (f-DSMP) and to an Attention Control (AC) intervention   "
199741|NCT00454948|"     Obesity among Mexican-American women has the potential to become a public health crisis.     Hispanics are one of the fastest growing minority populations in the United States and the     prevalence of obesity in Mexican American woman is increasing at an alarming rate. Poor     dietary practices, especially food habits that are acquired as families acculturate to the     American food supply, and lack of exercise are thought to be associated with women's excess     weight gain. Accordingly, interventions are needed to improve the dietary intake and physical     activity levels of Mexican-American families.      We propose to conduct a randomized clinical trial in which women are randomly assigned to     receive either family-based behavioral counseling (FBC) sessions and play group physical     activity sessions or group based nutrition and exercise classes and health related activity     worksheets to complete with their child. The FBC sessions, conducted by community health     advisors, will use photographs of the family's food practices, taken by mothers, as visual     aids in the counseling sessions. The control intervention will consist of group sessions     using curricula designed to motivate women to exercise and to promote the Food Guide Pyramid     recommendations using traditional Mexican-American foods. The primary outcome of the trial is     mother's BMI. The secondary outcomes are dietary intake, moderate to vigorous physical     activity and household food supplies. We hypothesize that within a one year time frame, women     who are exposed to the FBC will have lower BMI's compared to women who receive the active     placebo control intervention. The mechanisms through which we intend to change weight status     are altering the type of foods purchased and cooking practices and promoting mothers to     engage in physical activities with their children during their play. Measurements of     secondary outcomes include three 24 hour dietary recalls, a household food inventory and     activity monitoring using MTI actigraph monitors. In addition, mothers' reports of household     food security level, and food purchase motives, will be collected as covariates. Measurements     will be collected within one month of completing the interventions and at six months and one     year follow-up.   "
199742|NCT00454961|"     The purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine     (Coartem®) treatment provided by community health workers against uncomplicated malaria in     children under 5 years of age in Kibaha District, Tanzania, during an extended follow-up of     42 days. The hypothesis is that artemether-lumefantrine treatment provided by community     health workers will result in less than 85% PCR-corrected parasitological effectiveness by     day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.   "
199743|NCT00454974|"     This is a pilot study of a wearable type of kidney dialysis machine to treat patients with     chronic kidney disease.   "
199744|NCT00454987|"     The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48     months after the administration of a booster dose of Menitorix™, given at 12-15 months of     age. The children had previously received 3 doses of Menitorix™ and Infanrix™ IPV or     Meningitec™ and Pediacel™ in infancy. In addition, the antibody persistence is to be     investigated in children of 40-43 months of age who received a 3-dose primary vaccination of     a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of     MenC conjugate and Hib vaccine in the second year of life.      This protocol posting deals with objectives & outcome measures of the extension phases at 12,     24 and 48 months after the booster phase. The objectives & outcome measures of the primary     phase & booster phase at 12 to 15 months are presented in a separate protocol posting (NCT     number =00258700 ).   "
199745|NCT00455000|"     The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and     well tolerated in Adults with Mild to Moderate Alzheimer's disease.   "
199746|NCT00455013|"     The purpose of this clinical research study is to learn if belatacept (BMS-224818) is     expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based     immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The     long-term safety and tolerability of belatacept based regimens following long-term     administration in subjects who have received a kidney transplant   "
199747|NCT00455026|"     Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect     of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our     hypothesis is that this new method will more accurately predict depth of anaesthesia than the     Bispectral Index (BIS) monitor in patients having elective surgery.   "
199748|NCT00455039|"     Neoadjuvant chemotherapy has become the standard of care for breast cancer patients with     large tumors in order to render them operable for mastectomy or, in some cases, for     lumpectomy and radiation therapy. Building on this theme, several large hormonal therapies     are extensively investigated in the neoadjuvant setting, together with biologic correlates     for response and resistance. As a further extension, neoadjuvant therapies with biologic     agents are now too, being investigated for biologic evidence of efficacy before large-scale     clinical trials of thousands of patients are embarked on. The neoadjuvant setting is     especially attractive for these studies for several reasons including early assessment of     response to therapy, biopsiable access to the primary tumor, and considerable reduced sample     sizes compared to those required in the adjuvant setting. In addition, clinical response to     neoadjuvant chemotherapy is a validated surrogate marker for improved survival. It may be     used to test the overall efficacy of neoadjuvant treatment regimens and mirrors the effect of     therapy on micrometastases setting. In a recent study, good clinical response to neoadjuvant     chemotherapy was the only independent variable, by multivariate analysis, associated with     decreased risk of death.      GW572016 is a new and promising dual tyrosine kinase inhibitor against HER1/2. Hundreds of     patients were treated in phase I and II studies world-wide and results indicate that this     reversible, oral small molecule is generally well-tolerated. Studies of neoadjuvant     Trastuzumab indicate that HER2 interference leads to significant tumor regression even after     3 weeks of monotherapy. We aim to extend these findings with a novel agent, GW572016 that may     be more effective, especially from its in vitro data, and to discover the true response rate     to inhibiting HER1/2 signal transduction in breast cancer patients.   "
199749|NCT00455052|"     This amended expansion phase of the protocol is to further the experience at a dose level of     150 mg CPT eq/m2 in patients with Stage IV non-small cell lung cancer (NSCLC) and small cell     lung cancer (SCLC) and to test for preliminary anti-tumor activity in these tumor types. The     MTD was initially defined as 113 mg CPT equivalents(eq)/m2 in the dose escalation part of the     study. However, in the initial expansion phase (Protocol Amendment 11), 11 patients (10 NSCLC     patients and 1 gastric cancer patients) were dosed at 113 mg CPT eq/m2 and less bone marrow     toxicity was observed as compared to more heavily pre-treated patients in the dose escalation     part of the study. Therefore, this amended expansion phase will investigate the safety and     anti-tumor effects of a dose of 150 mg CPT eq/m2.      The study will also determine:        -  The safety and tolerability of XMT-1001 at 150 mg CPT eq/m2        -  The pharmacokinetics (PK) of XMT-1001 (how XMT-1001 behaves in the body) in patients          Stage IV non-small cell lung carcinoma (NSCLC) and small cell lung cancer        -  Evidence of XMT-1001 anti-tumor activity at 150 mg CPT eq/m2   "
199750|NCT00455065|"     The purpose of this study is to determine if intake of whole grain foods as part of a     hypocaloric diet enhances weight loss and improves cardiovascular disease risk factors in men     and women with metabolic syndrome.   "
199751|NCT00455078|"     Recent data has suggested that GER (gastric reflux) may worsen after lung transplantation and     potentially increase the risk of chronic rejection (CR) after lung transplantation.      The purpose of this study is to look at how often GER occurs in the lung transplant     population and examine how GER may change the immune system and cause CR. In this way, we     would be able to better identify patients that may benefit from anti-reflux procedures.   "
199752|NCT00455091|"     Research Objective and Study End Points To evaluate the anti-HBV as well as HCC recurrence     reducing effects of standard (18 months) lamivudine treatment at time of HBV reactivation     with hepatitis flare up (HBV DNA > 105 copies/mL and ALT level > 2.0 x UNL) or prophylactic,     prolong (36 months) adefovir dipivoxil therapy in post-operative HBsAg(+),< 5 cm HCC     patients, and to compare the results of who group with historical controls (T1297, HBsAg+,< 5     cm HCC cohort),in terms of the following endpoints.        1. Primary endpoint:           the 3-years recurrence rate (excluding those recur within first year).        2. Secondary endpoints:      the first 2 year tumor recurrence rates the recurrence-free survival the overall survival.     anti-viral efficacy, i.e. biochemical response and viral response rate. to correlate the     changes of viral titer with the clinical outcome in post- operative HCC patients with     adjuvant lamivudine or adefovir therapy.   "
199753|NCT00461175|"     The primary objective of the study is to assess the risks of intrauterine device (IUD) use in     a study population that is representative for the actual users of the individual IUDs. The     primary clinical outcome of interest is the uterine perforation rate.   "
199754|NCT00461188|"     The research is aimed at identifying new predisposition genes for endocrine tumours. Our     focus initially is on pituitary adenomas including growth hormone-secreting tumors     (somatotrophinomas) and prolactin secreting tumours (prolactinomas), but we wish to extend     work to other pituitary tumour cases/families.      The recruitment process will be as follows.        1. We will recruit patients from our own Endocrine outpatient clinics and inpatient wards.          In addition we will ask colleagues in other Endocrinology Departments (or other          specialties such as Clinical Genetics,Pathology, General Medicine ) to identify          potentially suitable patients with endocrine & pituitary tumours from their records. We          shall focus on patients with good evidence of inheritance of their condition: relatively          early onset; or multiple lesions; or other affected family members. Conditions where the          predisposing genes have been identified (principally MEN) will be excluded from study.          Patients directly contacting us can also enter the study.        2. The Consultant looking after the patient will contact the patient to initially inform          him/her of the study.        3. We will then contact the patient (generally by telephone) to discuss the study and what          it would entail in terms of information and samples.        4. Subject to agreement in (3), patient will receive 'Information Sheet for patients with          pituitary tumour' and 'Consent Form' and will have blood sampling in Consultant's          clinic.        5. We will contact additional family members (if appropriate) after an initial approach by          the family member already recruited to the study. The additional family members may have          developed tumours similar to those of the proband, or may be unaffected individuals who          provide useful information for gene identification purposes (for example, spouses may          greatly aid the power of gene mapping by linkage. They will receive the Information          Sheet for family members. analysis).      8. Archival tissue will be obtained from HTA licensed tissue banks. This is an established     bank whose licence is primarily for diagnosis but can be used for research. 9. We will     undertake laboratory work, such as genetic linkage analysis, candidate gene mutation     screening and studies of loss of heterozygosity in tumours, to identify the genes     predisposing to the condition, such as the AIP gene. In addition we would like to screen     other genes related to the chaperon AIP molecule, such as AhR, and other genes currently     identified (PDE4A5, survivin and Tom20 protein) or may not been identified.      Blood samples for DNA and RNA will coded with unique ID numbers. Pituitary and other     endocrine tumour samples will be collected at surgery and kept in liquid nitrogen or −80 C.     They will be coded with unique ID numbers. Candidate gene sequencing will be performed in the     Barts and the London Medical School Genome Centre.      RNA expression studies from blood or adenoma tissue samples will be performed by RT−PCR.     Protein expression studies will be performed by Western blotting or immunohistochemistry. The     first gene we wish to study causes familial acromegaly, a disease resulting from a pituitary     adenoma secreting growth hormone.      To establish if the candidate gene is also causing possibly sporadic (not familial) cases of     the disease, samples (blood and tissue) will be collected from patients with sporadic disease     and will be analysed as above.   "
199755|NCT00461201|"     The purpose of this study is to compare the effectiveness of nursing care in relation to     usual medical care in adult patients who demand to be visited the same day in Primary Care     Teams in Catalonia, as it is suggested in other countries.   "
199756|NCT00461214|"     The purpose of the General Surgery Training Outcomes Project: Evaluating the Impact of the     Curriculum on General Surgery Resident Training and Evaluation is to analyze data collected     as a normal course of the general surgery curriculum. The information collected is data     readily available and routinely collected on all participants in the general surgery     curriculum at NewYork Presbyterian Hospital/Columbia Campus. This information may lead to     improvement in the general surgery curriculum.   "
199757|NCT00461227|"     Asthma is a major public health problem among Puerto Ricans. Little is known, however, about     the effect of heredity and environment on the development and severity of asthma in this     population. This study will examine the relationship between asthma and certain genetic and     environmental factors in Puerto Rican children.   "
199758|NCT00461240|"     Growth hormone (GH) is important for growth in childhood, but also has important effects on a     number of tissues throughout life. GH deficiency and GH excess (acromegaly, caused by a     pituitary tumour) are both cause serious abnormalities of metabolism and long−standing     abnormal GH status causes abnormal heart function. In both cases cardiovascular disease is a     leading cause of early (premature) death. In the current study we wish to investigate the     energy status of the heart in patients with GH excess and deficiency and compare that with     age−matched controls. We will perform a blood test to study metabolic parameters. We will     perform measurements before treatment, after normalisation of improvement of GH levels and 2     years after start of treatment.      Objectives        1. Determine cardiac and skeletal muscle energy metabolism in patients with GH excess          (=acromegaly) or GH deficiency and detect changes after normalisation of GH and IGF−1          levels. (IGF−I is a hormone directly influenced by GH)        2. To correlate muscle energy metabolism parameters to GH and IGF−1 status in the control          subjects and in both patient groups        3. Determine the prevalence of coronary artery calcifications in patients with GH excess          and GH deficiency and correlate this with their metabolic status        4. To correlate coronary artery calcifications to abdominal obesity. Patients will be          identified by Endocrinology physicians involved in the study in outpatients clinics or          Endocrine wards and they will receive standard care for their disease. Tests related to          endocrine hormone abnormalities will be performed as usual clinical practice. The study          will involve three 3−hour visits to the Oxford Research Centre and two 1−hour visits to          London Scanning Centre.      The visits at the Oxford research centre will include Cardiac and skeletal investigations        -  Standard cardiac MRI will be used to measure right and left ventricular morphology and          global function.        -  31P Magnetic Resonance Spectroscopy (MRS) to monitor heart muscle energy levels (by          measuring intracellular PCr and ATP in heart muscle).        -  Heart failure severity (so called 'NYHA status') will be determined from the 6 min walk          test.        -  Peak oxygen uptake will be estimated from a metabolic gas exchange analysis performed          during maximal treadmill exercise testing.        -  Skeletal muscle MR imaging and spectroscopy will be performed at rest and during          exercise.        -  Fasting blood test will be performed, see details in protocol.        -  Electrocardiogram (ECG)        -  Epworth Sleepiness Scale questionnaire and 5 point test for sleep apnoea The visits at          the London Scanning Centre will include        -  Electron beam coronary CT (EBCT) to assess coronary disease. The number of coronary          disease lesions will be measured in several coronary arteries and values will add up to          an overall score. In addition a single picture will be taken at the level of the          umbilicus (belly button) to measure fat tissue within the abdomen. Patient selection:          Patients will be recruited at St. Bartholomew's Hospital (Dr P. Jenkins and Prof. A.          Grossman), King's Hospital (Dr S. Aylwin) and St Thomas's Hospital (Dr P. Carroll) in          London, Royal Free Hospital (Prof P. Boloux), the John Radcliffe Hospital Oxford (Prof          J. Wass), Addenbrooks Hospital Cambridge (Dr H. Simpson), Sheffield (Dr J.          Newell−Price), and Stroke−on−Trent (Prof R. Clayton) from the Endocrine Wards and          outpatient clinics. This constitutes a large recruitment base. We estimate that 45 new          acromegaly patients and 60−80 new GHD patients per year will be screened. Patients will          be selected on the basis of clinical diagnosis of acromegaly or GH deficiency (see          details of these in the formal protocol).      Patients will be managed according to the clinical protocols of the referring centre.      The patients will have a report of their investigation results with their treating     physicians.      Control subjects will be selected from the general population via advertisements. They will     undergo all tests in the Oxford centre once.      Expected value of results:      These studies will increase our knowledge of the metabolic changes associated with GH excess     and GH deficiency, which can lead to increased cardiac morbidity and mortality in both cases.     Our studies will help to clarify the mechanism of abnormal cardiac function. The study has     been powered to have appropriate number of subjects within a two year period, therefore we     anticipate that it will last from start to finish 4 years.   "
199759|NCT00461253|"     The objective of this study is to determine the breast cancer risk of Mirena® users compared     to copper intrauterine device (IUD) users in a community-based case-control study.   "
199760|NCT00461266|"     This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral     regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count <250 cells/mm3 and an     HIV RNA viral load <400 copies/mL. Eligible patients will be randomized to receive Fuzeon     90mg bid sc in addition to their current antiretroviral therapy, or to continue their current     antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the     target sample size is <100 individuals.   "
199761|NCT00461279|"     In this study, the focus is on an individual's attachment security and its relation to     treatment outcome in Major Depression.Adult attachment reflects how one seeks psychological     and physical proximity to others for security and protection in times of stress. Researchers     typically define four types of attachment security: one secure and three insecure     (preoccupied, dismissing, and fearful). Adults with Major Depressive Disorder (MDD) will be     randomly assigned to either Interpersonal Psychotherapy (IPT) or to Cognitive Behavior     Therapy (CBT). The expectation is that adults with avoidant attachment styles will respond     better to CBT, and adults with preoccupied attachment styles will respond better to IPT.     Also, in comparison to CBT, outcome in IPT is hypothesized to be more closely related to     change in attachment.   "
199764|NCT00461318|"     The primary aim of the study was to determine the effectiveness of a form of supported     employment, Individual Placement and Support (IPS) compared to existing good quality     rehabilitation and vocational services for people with psychotic illnesses in terms of ‘open’     employment outcomes (in the competitive labour market), and to examine its relative     effectiveness in the context of different European welfare systems and labour markets. The     primary hypothesis was that IPS patients would be more likely to obtain open employment than     control service patients. Secondary hypotheses were that they would be in open employment for     longer than the control patients, and that they would not spend more time in hospital.   "
199765|NCT00461331|"     The purpose of the study is to compare the glycemic control between insulins aspart and     lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes     using an insulin pump.   "
199766|NCT00461344|"     Primary: To determine the pathological remission following the chemotherapy combination     docetaxel and doxorubicin in large breast cancer      Secondary:        -  Clinical response rate        -  To investigate the safety of docetaxel doxorubicin combination in the treatment for          neoadjuvant chemotherapy of breast cancer        -  Type of surgery (radical/conservative)   "
199767|NCT00461357|"     The Eurotransplant Senior Program (ESP) started in 1999 with local allocation of kidneys from     deceased donors elder than 65 years to recipients elder than 65 years. The requirements for     immunosuppression in this group of patients are high due to the large amount of     comorbidities.      This prospective randomized trial compared the standard immunosuppressive protocol based on     cyclosporine A (CyA) used at our center within the ESP, to a calcineurin inhibitor-free     protocol based on sirolimus (SRL).      The aim of this study is to investigate the effect of a CNI-free therapy on the function of     elderly kidneys 6 months post transplantation, measured by GFR.   "
199768|NCT00461370|"     The purpose of this study is to determine the safety of SRX251 when given orally. The amount     of SRX251 in the blood will also be measured. Healthy women, ages 18-50 years who have been     surgically sterilized by tubal ligation, will be enrolled in this study.   "
199769|NCT00461396|"     -  The primary aim of this study is to evaluate the impact of titration, analgesics, and 12          month telephone follow-up period from the B.E.T.A nurse program upon adherence to          treatment with Betaseron in patients with a first clinical demyelinating event          suggestive of Multiple Sclerosis (MS) and patients with onset of RRMS within the past 12          months        -  Secondary outcomes include analysis of the following parameters: progression of clinical          severity by the expanded disability status scale (EDSS score), health related quality of          life (HrQoL), and safety.        -  Exploratory outcomes include changes over time in cytokine and neurotrophic factor          production by immune cells and visual function as assessed by visual examination, OCT          measurements and a neuro-ophthalmologic Health-Related Quality of Life questionnaire          (NEI-VFQ-25) with 10-item supplement.   "
199770|NCT00461409|"     The purpose of this study is to determine the correct dosing for intravenous levetiracetam in     term new born babies with seizures. In addition information on safety and efficacy will be     collected. This new anticonvulsant drug is a promising treatment for seizures in newborns.   "
199771|NCT00461422|"     Our goal was to investigate whether early follicular supplementation of the GnRH antagonist     to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results   "
199772|NCT00461435|"     Our aim was to assess the role and usefulness of Hyperbaric oxygen therapy in a long lasting     period, assessing its efficacy on rescuing retinal photoreceptors and preserving visual     function in retinitis pigmentosa.   "
199773|NCT00461448|"     Rheumatoid arthritis is the paradigmatic immune-mediated inflammatory arthropathy. With     respect to rheumatoid arthritis (RA), patients have been described as having inappropriately     low spontaneous and stimulated cortisol secretion levels. Serum cortisol levels are decreased     in RA patients who are taking prednisolone. Also, in patients RA, of longer duration,     glucocorticoid receptor (GR) down-regulation has been reported without any change in cortisol     levels. There is a reduced capacity for local reactivation of cortisone to cortisol in RA     synovial cells. It is noteworthy that since synthetic glucocorticoids also use same     reactivation shuttle (the cortisol-cortisone shuttle), the results also apply to therapeutic     glucocorticoids.      Glucocorticoids are widely used to treat chronic inflammatory conditions including rheumatoid     arthritis. Prednisolone has a greater effect than non-steroidal, anti-inflammatory drugs on     joint tenderness and pain, whereas the difference in grip strength was not significant. There     are no qualitative differences between the effects of endogenous cortisol and exogenously     applied synthetic glucocorticoids, since all effects are transmitted via the same receptor.     Cortisol, on the other hand, plays a major role in normal potassium homeostasis.      Recent studies have highlighted a role for diet, with suggestions that diets high in     caffeine, low in antioxidants and high in red meat may contribute to an increased risk for     the development of rheumatoid arthritis. Higher intakes of complex carbohydrates, dietary     fiber, magnesium, folic acid, vitamin C and E, carotenoids and other phytochemicals have been     shown to offer distinct advantages compared to diets containing meat and other foods of     animal origin. The relation of a potassium deficiency to RA is much less well documented. The     first person to definitively link potassium with arthritis was DeCoti Marsh. LaCelle, Morgan     & Atwater found that the cells of 50 arthritic patients were 30 to 50% lower than healthy     people.      Our current clinical trial (clinical trial no NCT00399282) shows that most of patients with     RA do not have enough potassium intake. This condition may contribute to a subclinical lower     serum cortisol, although there is possibility that cortisol serum levels might be unchanged     due to a sufficient cortisol homeostasis and potassium homeostasis.   "
199774|NCT00461461|"     Medical errors that affect patient safety have generated huge concern since the publication     of To Err Is Human 6 years ago [1]. Given the complexity of management in the intensive     care unit (ICU) and the nature of human activities, critically ill patients are exposed to     adverse events (AEs) induced by medical errors. A large number of studies have focused on AEs     and medical errors in ICUs [2-6], one of their main goals being to identify strategies for     preventing AEs and thereby improving patient outcomes. Choosing the best AE to serve as an     indicator for the risk of medical error is challenging. In 2005, our group conducted a     systematic literature review and presented the results to 30 national experts with clinical     backgrounds in internal, emergency, and intensive care medicine. Using the Delphi technique,     these experts selected 14 AEs that had the following characteristics: high frequency, easy     and reproducible definition, association with morbidity and mortality, and ease of reporting     without fear of punishment (Iatroref I study) (ref abstract). These AEs were used in a French     multicenter study (75 ICUs) for a weeklong incidence evaluation (Iatroref II study) (ref     abstract). Preliminary evaluation of the results allowed us to choose the following AEs for     the current Iatroref III study: error in insulin administration, error in anticoagulant     administration, error in anticoagulant prescription, unplanned extubation, and unplanned     removal of central venous catheter. Evidence suggests that guidelines alone without     reinforcing strategies may be insufficient to change provider behavior and that the most     effective interventions may be multifaceted rather than single-component strategies ([7]).     This study will test a composite intervention program. The objectives of the study are to     determine whether the introduction of a composite intervention program decreases the     predefined AEs.      Study hypothesis: The intervention program will decrease the incidence of the predefined AEs.   "
200883|NCT00478868|"     To assess: a) The prevalence of Modic changes and other findings on lumbar magnetic resonance     imaging (MRI), among Spanish adult chronic LBP patients, b) Patient characteristics and     radiological findings associated with Modic changes.   "
199775|NCT00461474|"     The purpose of this study is to conduct research to see if we can help people who have a     spinal cord injury and shoulder pain to decrease the pain in the shoulders. We are     investigating the effectiveness of a home exercise program for the shoulders and changes in     how tasks are performed compared to an educational program on shoulder pain. There are no new     experimental procedures included in this study; instead it is a comparison of two types of     treatment that have been provided for this problem before. The new part of this study is the     collecting of information before and after treatment. We hypothesize that those who     participate in this home exercise program will have decrease shoulder pain and increase     activity.   "
199776|NCT00461487|"     This study will evaluate the effectiveness of a parent-based intervention in reducing sexual     risk behavior in high-risk Latino and African-American adolescents.   "
199777|NCT00461500|"     This study will compare during 12 weeks, two treatment strategies for Initial Maintenance     Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination     in adults with moderate persistent asthma   "
199778|NCT00461513|"     The purpose of this study is to evaluate a patient-centered disease management intervention     for VA patients with heart failure.   "
199779|NCT00461799|"     The purpose of this study was to determine whether orlistat is effective in decreasing plasma     unconjugated bilirubin levels in patients with Crigler-Najjar disease.   "
199780|NCT00461812|"     The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate     comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in     control of mild persistent asthma?      The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy     with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50,     when measured by this standard methodology (methacholine bronchoprovocation) in subjects with     mild persistent asthma.   "
199781|NCT00461825|"     We have previously defined factors that predict the long term success of maintenance CsA     monotherapy (CsAm) after kidney transplantation : donor age < 40 years, serum creatinine     level at the initiation of CsAm £ 125 µmol/L, no rejection episode before CsAm initiation. We     have also shown that the 8-year graft survival in 329 selected patients enrolled in     maintenance CsA-m was 84 % (Hurault de Ligny et al, Transplantation, 2000 ; 69 : 1327-1332).     These results were obtained with an old formulation of cyclosporin, azathioprine, steroid     withdrawal over the first year and induction antibody. This prospective randomized     multicentre study was designed to clarify whether maintenance Neoral + MMF or Neoral + AZA is     better than a CsAm and wether Neoral + MMF is better than Neoral + AZA in low immunological     risk cadaveric kidney transplant recipients.   "
199782|NCT00461838|"     Improved pain, sexuality and quality of life, high fertility and low complication and     recurrence rates after multidisciplinary CO2 laser laparoscopic excision of deep infiltrating     colorectal endometriosis.   "
199783|NCT00461851|"     This is a Phase II, nonrandomized multicenter study designed to evaluate time to progression     and response proportion of patients with advanced or metastatic transitional cell carcinoma     of bladder receiving 6 cycles of gemcitabine, carboplatin and sorafenib and then maintenance     sorafenib.   "
199784|NCT00461864|"     occult hip fractures present to the emergency room with a history of trauma,a painful hip and     normal X-ray. these patients usually undergo other imaging modalities such as CT scans, MRI,     or bone scans.      In this study we check the sensitivity and specificity of a directed ultrasound examination     of the hip joint in diagnosing or excluding a hip fracture. We also compare the results of     ultrasound examination by the orthopedic surgeon in the emergency room versus the consultant     radiologist.      The patients undergo bone scans or CT to make the diagnosis.   "
199785|NCT00461877|"     The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year     old women who report having used internet dating websites in the past year.   "
199786|NCT00461890|"     The goal of the proposed project is to improve the primary care treatment of veterans with     alcohol dependence. Alcohol dependence is a common behavioral health problem among veterans     treated in VA primary care clinics. However, assessment and treatment of alcohol dependence     in primary care remains problematic. Assessment of veterans with positive alcohol use screens     may not always be completed and referrals to specialty care may not always be made. Moreover,     the use of medications for alcohol dependence among veterans is rare, despite VA treatment     guidelines that recommend such use. Finally, when medications are prescribed, patients may     have difficulties with adherence.      The primary aim of this study is to assess the feasibility of long-acting injectable     naltrexone provided through primary care (LAN/PC) versus long-acting injectable naltrexone in     the specialized chemical dependence clinic (LAN/CDC). The secondary aim is to obtain     preliminary assessments of the relative effectiveness of long-acting injectable naltrexone in     primary care versus in the chemical dependence clinic.   "
199787|NCT00461903|"     The purpose of this 7- to 13-month study is to determine the efficacy of 8 mg/day oral     perindopril to prevent the recurrence of atrial fibrillation (AF) in patients with essential     hypertension.   "
199788|NCT00461916|"     The purpose of this study is to determine whether half-dose depot triptorelin are as     effective as reduced-dose daily buserelin in the controlled ovarian stimulation for     intracytoplasmic sperm injection and embryo transfer   "
199789|NCT00461929|"     In order to distinguish between clonal instability driven by imatinib in CML and actual     changes with secondary clones induced by imatinib we would like to investigate the karyotype     of non-CML patients treated with imatinib such as GIST patients.   "
199790|NCT00461942|"     The purpose of this study is to determine whether Green Tea Polyphenol, an extraction from     Green Tea is effective and safe in the treatment of De Novo Parkinson's disease Patients     without taking any antiparkinsonism drug   "
199791|NCT00461955|"     Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after     injection of ex vivo amplified graft and by a platelets number > 20000/mm3, at day 15 after     the injection of ex vivo amplified graft, without transfusion.   "
199864|NCT00462982|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with     brain metastases caused by kidney cancer or melanoma.   "
199792|NCT00461968|"     The purpose of this study is to compare the percent change in LDL cholesterol induced by     ezetimibe or simvastatin monotherapy and by co-administration of both agents in Black, White     and Hispanic men. Ezetimibe is a drug that blocks sterol absorption and simvastatin blocks     hepatic cholesterol biosynthesis. The hypothesis to be tested is that Blacks are likely to be     more responsive to LDL lowering by ezetimibe than statins because Blacks have a low     production of cholesterol.   "
199793|NCT00461981|"     The primary objective of this study is to describe the level of serum antibody and cellular     immune responses conferred by FluMist and TIV against influenza virus strains.   "
199794|NCT00461994|"     A 3-arms randomized prospective intervention study to determine the roles of exercise and/or     diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with     BMI> 95th percentile for age and gender. Children were randomly allocated into three groups.     The first group underwent an exercise program, the second one underwent both an exercise     program and a diet program and the third underwent a diet program alone.      The total duration of the intervention is 12 weeks followed by a period of 9 months of     follow-up. The effects of the different intervention on weight loss and weight     maintenance,body composition, on hormonal components that regulate the caloric balance, on     metabolic profile and cardiovascular risk factors and on psychological parameters were also     determined.   "
199795|NCT00462007|"     An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated     Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The     study will consist of 2 consecutive periods: screening period and study treatment period.     Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will     be determined by the subject's current, separately administered standard levodopa/DDCI     treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be     switched to an equivalent dose of Stalevo® without changing the number of doses per day. The     levodopa daily dose during Stalevo® treatment may be adjusted according to the study     subject's clinical response.   "
199796|NCT00462020|"     The objective of this study is to scientifically evaluate two different management strategies     for perforated appendicitis.      The hypothesis is that early discharge with oral antibiotic therapy may result in a dramatic     decrease in medical care expenses for the patient.      The primary outcome variable between the two strategies is abscess rate.   "
199797|NCT00462046|"     Berberine has showed effective in lowering blood sugar levels in db/db mice and     anti-dyslipidemia in human. These findings have not been tested in a clinical trial. This     randomized, double blind, placebo controlled and multi-center study has demonstrated that     berberine is effective in lowering plasma glucose concentrations, reducing serum HbA1c and     anti-dyslipidemia in type 2 diabetic patients with dyslipidemia.   "
199798|NCT00462059|"     The purpose of this study is to assess and compare the effectiveness of the Kaiser Permanente     Colorado’s (KPCO) Call Center’s Medication Reconciliation Program and standard care in     regards to their impacts on emergency department (ED) and urgent care visits, inpatient     rehospitalizations, and adherence to preferred, formulary medications.   "
199799|NCT00462072|"     Specific Aim 1. To determine the transcriptome of peripheral blood mononuclear cells isolated     monocytes and target tissues in IMIDs.      Specific Aim 2. To analyze the change in gene expression profiles in patients with Crohn's     disease, psoriatic and rheumatoid arthritis before and after infliximab therapy.   "
199800|NCT00462085|"     The purpose of this study is to investigate the change in muscle activity during gait with     the use of ankle foot orthoses in children diagnosed with hemiplegic cerebral palsy.   "
199801|NCT00462098|"     Osteonecrosis of the jaw (ONJ) has recently been recognized as associated with bisphosphonate     therapy, however there is little information on the natural history, treatment or prevention     strategies for this condition. The purpose of this study is to determine the effectiveness of     hyperbaric oxygen as a treatment. We will randomize 35 out of 70 ONJ patients to receive HBO     in addition to their routine oral surgery care and follow both groups over a 2-year period.   "
199802|NCT00462111|"     The purpose of this study is to determine whether indometacin has an effect on reaction time,     postural stability, and the avoidance of obstacles.   "
199803|NCT00462124|"     Primary Goal The study's primary goal is to assess the safety of the BioProtect biodegradable     balloon implant and implantation procedure, in prostate cancer subjects undergoing routine     XRT treatment. Safety of the BioProtect device will be assessed by reporting adverse events.      Secondary Goal The study's secondary goal is to evaluate the effectiveness of the BioProtect     biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment.     Effectiveness will be assessed in terms of increased distance between anterior rectal wall     and prostate and noticeable reduction of isodose to the rectum.   "
199804|NCT00462137|"     This is a continuation of a study that has already been completed in the division of     gastroenterology (GI) looking at the effects of sleep medication zolpidem (Ambien) on     subjects with Gastroesophageal reflux disease (GERD). That study looked at 16 subjects, 8 who     had been diagnosed with GERD and 8 who did not have GERD (IRB Control #04S.41). All subjects     previously had a PH probe completed in the division of GI at Thomas Jefferson University. An     additional 8 subjects with GERD will be recruited to obtain more data to add to the previous     study results. These subjects will undergo 2 sleep studies, one in which they will be given     Ambien and one in which they will not.   "
199805|NCT00462150|"     The purpose of the study is threefold: 1) to develop a home-based emotional disclosure     intervention inducing core elements of change (emotional engagement, cognitive restructuring,     and positive future directedness); 2) to examine in a randomized controlled trial in patients     with rheumatoid arthritis the induction of the core elements and the feasibility of the     intervention for home application; and, 3) to examine the psychological, clinical, and     physiological effects of the adapted emotional disclosure intervention and the modulating     role of cognitive-emotional change and individual differences in emotion regulation.   "
199806|NCT00462176|"     This study is executed to evaluate the outcome on quality of life, pain, sexuality, pregnancy     rate and recurrence rate after a fertility sparing multidisciplinary CO2 laser laparoscopic     radical excision of deep infiltrating colorectal endometriosis with a bowel resection.   "
199807|NCT00462189|"     RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal     cells. This may be an effective treatment for hairy cell leukemia(HCL) that has not responded     to chemotherapy, surgery or radiation therapy.      PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015     immunotoxin in treating patients who have hairy cell leukemia (HCL) that has not responded to     treatment.   "
199808|NCT00462202|"     The purpose of this study is to assess the tolerability and safety of KRX-101 in treating     persistent microalbuminuria in type 2 diabetic patients who are also being treated with     stable, maximum tolerated doses of either ACE inhibitors or A2 receptor blockers.   "
199809|NCT00462215|"     The objectives of this study are to assess the immune response as well as the safety and     tolerability of an H5N1 influenza vaccine in an adult and elderly population. Further, the     study will assess the need for a booster vaccination and whether a 6-month booster or a     12-month booster is more appropriate. An independent data safety monitoring board will review     and evaluate the safety data obtained in this study on an ongoing basis.   "
199810|NCT00462228|"     The purpose of this study is to determine whether memantine (Namenda) improves memory and     attention in patients with mild to moderate traumatic brain injury.   "
199811|NCT00462241|"     Acute chest pain is a common cause of hospital admission. Active approaches are directed     towards diagnosis and treatment of potentially life threatening conditions, especially acute     coronary syndrome and coronary artery disease. However, a considerable number of patients may     have chest pain caused by biomechanical dysfunction of muscles and joints of the chest wall     or the cervical and thoracic spine (20%). The diagnostic approaches and treatment options for     this group of patients are scarce and there is a lack of formal clinical studies and     validated outcome measures addressing the effect of manual treatment approaches.      Objective: This single blind randomized clinical trial investigates whether chiropractic     treatment can reduce pain and improve function in a population of patients with acute,     musculoskeletal chest pain when compared to advice directed towards promoting     self-management.      Methods: Among patients admitted to a chest pain clinic in a university hospital under     suspicion of acute coronary syndrome, 120 patients with an episode of acute chest pain of     musculoskeletal origin are included in the study. All patients have completed the chest pain     clinic diagnostic procedures, and acute coronary syndrome and other obvious reasons for chest     pain have been excluded. After completion of the study evaluation program, the patients are     randomized into one of two groups: A) advice promoting self-management and individual     instructions focusing on posture and muscle stretch; B) a course of chiropractic therapy of     up to ten treatment sessions focusing on high velocity, low amplitude manipulation of the     cervical and thoracic spine together with a choice of mobilisation and soft tissue     techniques. In order to establish suitable outcome measures, two pilot studies were     conducted. Outcome measures are pain, function, overall health, and patient-rated treatment     effect measured at 4, 12, and 52 weeks following treatment.   "
199812|NCT00462254|"     Patients with Parkinson's disease represent a significant proportion of VA elderly patients.     Sleep disturbances and caregiver burnout association with this condition represent a     significant problem. In this study, the investigators propose to perform an evaluation of a     fixed doe of ramelteon on sleep in VA outpatients diagnosed with Parkinson's disease.      The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients     with Parkinson's disease while indirectly improving the quality of life for the patients and     caregivers. The investigators further hypothesize that these changes will occur through     restructuring and normalization of the sleep architecture.   "
199813|NCT00462267|"     This project will examine the effectiveness of a primary care based intervention to help     overweight teen girls adopt healthy lifestyle practices. Participants will be adolescent     females from Kaiser Permanente Northwest primary care clinics with a body mass index above     the 90th percentile. Teens will be randomly assigned to (1) a behavioral weight control     program (enriched intervention), (2) brief primary care counseling (low intensity     intervention), or (3) usual-care (control). For both of the project's active intervention     arms, teens' primary care providers will be given customized plans describing the teen's     eating and physical activity habits and instructions on how to best work with these teens and     their families. The behavioral weight control program will be specifically tailored for teen     girls and will include separate group meetings for teens and parents, follow-up telephone     contacts with their group leader, and coordinated feedback from the teen's primary care     provider.   "
199814|NCT00462280|"     The use of lovastatin may slow disease progression in patients at high risk of melanoma. It     is not yet known whether lovastatin is more effective than a placebo in treating patients at     high risk of melanoma. This randomized phase II trial studies how well giving lovastatin or     placebo works in treating patients at high risk of melanoma.   "
199815|NCT00462306|"     Obstructive sleep apnea is a condition characterized by obstruction of the upper airways and     episodes of apnea and hypopnea during sleep. It is associated with significant adverse health     effects. The incidence of obstructive sleep apnea in the general female population is     approximately 2% but the incidence of obstructive sleep apnea in pregnancy is unknown. There     is some evidence that pregnancy precipitates or at least exacerbates this condition and that     there may be a relationship between intrauterine fetal growth retardation and maternal     preeclampsia. In addition, there are several anesthetic implications that are concern for the     patient with obstructive sleep apnea. These include: exquisite sensitivity to all central     nervous system depressant drugs and the potential for upper airway obstruction or apnea with     even minimal drug doses; difficult mask ventilation; difficult intubation; arterial     hypoxemia; arterial hypercarbia; polycythemia; hypertension; pulmonary hypertension and     cardiac failure. All of these conditions pose significant anesthetic risk for the patient,     and this risk may be increased further by pregnancy.   "
199816|NCT00462319|"     International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for     patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving     advices for these 2 points still low. This study evaluates the impact of a standardized     medical intervention (patient education, weight reduction and physical exercise) in knee     osteoarthritis patients.   "
199817|NCT00462332|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. A peripheral stem cell     transplant using stem cells from the patient or a donor may replace the patient's immune     cells that were destroyed by chemotherapy.      PURPOSE: This phase II trial is studying how well giving fludarabine together with     alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or     alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic     leukemia.   "
199818|NCT00462345|"     This single arm study will evaluate the efficacy and safety of MabThera in combination with     methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one     or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and     methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v.     prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The     anticipated time on study treatment is 3-12 months, and the target sample size is <100     individuals.   "
199819|NCT00462358|"     This is a Phase 1 study during which patients with advanced solid tumors will receive     investigational study drug ARRY-520.      This study has two parts. In the first part, patients with advanced solid tumors will receive     increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF)     support, in order to achieve the highest dose possible that will not cause unacceptable side     effects. Approximately 15 patients (per schedule) from the US will be enrolled in Part 1     (Completed).      In the second part of the study, patients will receive the best dose of study drug determined     from the first part of the study and will be followed to evaluate what side effects the study     drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 15     patients from the US will be enrolled in Part 2 (Completed).   "
199820|NCT00462371|"     Comparison between insulin pump treatment and multiple daily insulin injections in 38     children with type 1 diabetes4-16 years old. Outcome metabolic control, quality of life,     impact of disease and cost effectiveness.      We hypothesised that insulin pump treatment would give a better metabolic control and quality     of life.   "
199821|NCT00462384|"     This single arm study will assess the efficacy and safety of subcutaneous Mircera for     correction of anemia in participants with chronic kidney disease who are not on dialysis and     are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will     receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting     dose of 1.2 micrograms/kilogram [mcg/kg]). The anticipated time on study treatment is 3-12     months, and the target sample size is 100-500 individuals.   "
199822|NCT00462397|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving combination chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin     followed by cisplatin and radiation therapy works in treating patients with stage IB, stage     II, stage III, or stage IVA cervical cancer.   "
199823|NCT00462410|"     RATIONALE: Measuring how advertising affects treatment compliance in women with breast cancer     may help doctors plan the best treatment.      PURPOSE: This clinical trial is studying how advertisements affect treatment compliance in     women with breast cancer.   "
199824|NCT00462423|"     The study is an open-label, single arm multicenter Phase II study to evaluate the safety and     efficacy of the combination of Abraxane and Avastin as first-line therapy for patients with     unresectable metastatic malignant melanoma. The patient sample will be approximately 50     individuals, males and females 18 years of age or older with measurable metastatic melanoma.      Patients will be treated with Abraxane administered weekly for 3 weeks via a 30-minute IV     infusion at150 mg/m2 followed by 1 week rest (28-day cycle). Avastin will be administered in     a dose of 10 mg/kg every 2 weeks (without rest period). Patients will be evaluated for     disease progression every 2 months and those who do not have disease progression or     unacceptable toxicity will be offered ongoing therapy until they have progressive disease or     unacceptable toxicity.   "
199825|NCT00462436|"     Background: Treatment targets for cardiac risk factor reduction are not being met. Therefore,     there is a need for new strategies to assist patients in meeting these goals.      Objective: To determine the amount of any additional benefit on risk factor reduction     associated with the consumption of the dietary portfolio (a low fat diet with soy, nuts and     viscous fibres), above that achieved with medical management in diabetic patients following     cardiac surgery.      Description: 35 cardiac surgery patients with diabetes will be instructed on how to     incorporate the dietary portfolio foods into their diet for four weeks. Changes in blood     cholesterol, markers of inflammation, blood sugar control and modifiable risk factors will be     assessed after 2 and 4 weeks of therapy.      Relevance: Maximizing cardiac risk factor reduction through a combined approach (dietary plus     medication) should improve outcomes, reduce rates of re-hospitalization and improve quality     of life in diabetic patients after heart surgery.   "
199826|NCT00462449|"     FES is a form of treatment with a device to aid movement in people who have had damage to     their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves     that supply paralyzed muscles. This activates those muscles, enabling them to produce basic     but useful movement. Self-adhesive patches (electrodes) are placed on the skin close to the     nerve that supplies the muscle and are connected by wires to a stimulator that produces the     impulses. In this way, FES is used to correct the muscle weakness that is caused by injury to     the brain or spinal cord.      Repetitive task practice is an activity-based therapy program that has been shown to     enhance the recovery of hand and arm functions after stroke. This therapy consists of a set     of training activities that are designed by a qualified therapist specific to your functional     abilities that are to be performed with the impaired hand. These activities are designed to     stimulate functional improvement with repetitive practice.      Spasticity is a nervous system disorder where certain muscles are continuously contracted.     Botox injections are commonly used to help to reduce spasticity in areas of the body with     increased muscle tone. This research is designed to look at any additional benefit that may     occur when Botox injections are combined with specific occupational therapy exercises and     with a device that uses functional electrical stimulation (FES) to help improve muscle     function after stroke.   "
199827|NCT00462462|"     Absolute ethanol has been used off-label as an unmodified formulation (solution) in     Congenital Venous Malformations (CVM). Despite its effectiveness, absolute ethanol appears     difficult to handle because of its high diffusion capacity outside the CVM and in the blood     circulation. A less diffusible ethanol-based product (ethanol gel) has been developed in     order to minimize systemic and local diffusion capacities of ethanol. Therefore, the     pharmacokinetic parameters and their clinical and paraclinical outcomes between ethanol gel     96% and absolute ethanol need to be carried out.      FDA Office of Orphan Products Development (FDA OOPD) : Funding source.   "
199828|NCT00462475|"     Adult patients with hypopituitarism under adequate conventional hormone replacement therapy     have reduced life expectancy due to excess vascular events (1-4). Deficiency in GH secretion     (GHD) is likely to play a major role in determining the excess mortality, since it is     associated with lipid abnormalities, visceral adiposity, glucose intolerance, insulin     resistance, hypertension, cardiac abnormalities and increased intima-media thickness (IMT) at     major arteries (5).      Beneficial effects of growth hormone (GH) replacement on cardiovascular risk factors have     been demonstrated in several studies of hypopituitary GHD patients (5). GH replacement     improves body composition and lipid profile (5): it is accepted that management of     dyslipidaemia is crucial in primary and secondary prevention of cardiovascular disease and     part of the excess vascular risk associated with hypopituitarism is likely to be due to     dyslipidaemia (6). A meta-analysis of blinded, randomized, placebo-controlled trials with low     doses and long-duration GH treatment showed that GH replacement has beneficial effects on     cardiovascular risk by improving lean and fat body mass, total and LDL cholesterol levels,     and diastolic blood pressure (7). Besides, GH replacement also induces improvement in     cardiovascular markers (8), and cardiac performance (9). In small cohorts of GHD adults,     beneficial effects of GH replacement for 6-24 mos have also been reported on surrogate     parameters of atherosclerosis, such as intima-media thickness (IMT) at major arteries     (10-13), while 6 months of GH deprivation is associated with an impairment of the     cardiovascular risk profile (12). In a consistent series of men and women with     hypopituitarism we reported, however, that two years of GH replacement is not adequate to     normalize IMT levels at common carotid arteries (13).      To give further insights on the likelihood of reversal of early atherosclerosis in severe GHD     patients after prolonged GH replacement, we designed this 5-yr prospective, controlled study.     Only men aged ≤50 yrs and with severe GHD were enrolled to avoid gender and aging     interference (13). Main outcome measure was IMT at common carotid arteries; secondary measure     was prevalence of insulin-resistance syndrome according with the American College of     Endocrinology (14).   "
199829|NCT00462488|"     The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when     administered as a monotherapy intravesical instillation in patients with non-invasive     urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin     (BCG).   "
199830|NCT00462501|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab     may also stop the growth of rectal cancer by blocking blood flow to the tumor. Radiation     therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy and     bevacizumab together with radiation therapy before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed.      PURPOSE: This clinical trial is studying how well giving combination chemotherapy and     bevacizumab with or without radiation therapy works in treating patients with locally     advanced rectal cancer   "
199831|NCT00462527|"     Acute renal failure (ARF) is a rare but serious complication of gastroenteritis and     dehydration, the most common reason for pediatric emergency visits. Renal function is     determined by the glomerular filtration rate (GFR). Serum creatinine, the current marker of     GFR, is insensitive and a late marker of ARF. Unfortunately, gold standard methods for     measurement of GFR are impractical in the emergency setting. Recently, cystatin C (CysC) was     introduced as superior marker for the measurement of GFR, particularly in children. A single     random blood sample allows for accurate determination of GFR in the so-called     creatinine-blind range and independent of the body composition. There is growing evidence     that the determination of serum CysC concentration can detect ARF in adults earlier than     serum creatinine or urinary fractional sodium excretion. No studies have examined this marker     for the early detection of ARF in children at risk. We therefore propose a prospective study     that compares CysC with other biomarkers of renal dysfunction for the early detection of ARF     in children with dehydration due to gastroenteritis. Patients with minor trauma and a minimal     likelihood of ARF will serve as a control. This study may establish CysC as an accurate and     cost-effective marker for identifying patients at risk.   "
199832|NCT00462540|"     The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation     Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose     inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare     the preference/compliance of BID nebulization to QID use of MDI   "
199833|NCT00462553|"     This phase I trial is studying the side effects and best dose of sunitinib and gemcitabine in     treating patients with pancreatic cancer or other solid tumors. Sunitinib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood     flow to the tumor. Drugs used in hemotherapy, such as gemcitabine, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving sunitinib together with gemcitabine may kill more tumor cells.   "
199834|NCT00462566|"     The objective is to determine if motor cortex stimulation works for the following conditions:        1. Deafferentation facial pain,        2. Upper extremity complex regional pain syndrome (CRPS) and        3. Brachial plexus avulsion or phantom limb pain.      Each of these groups of 6 patients (total of 18) will be studied independently and all     patients will be implanted with a motor cortex stimulation system. They will be randomised to     either a regular or low stimulation setting in the two arms of the study. Each arm will last     3 months.   "
199835|NCT00462579|"     It has been demonstrated that panresistant strains of Acinetobacter species may be selected     by antibiotic use [4], may be transmitted from person to person [5], and may be passed via     environmental contamination [6]. Surveillance for panresistant Acinetobacter species should     be a priority, given the lack of antibiotic options for the treatment of these infections.     There are currently no data on the antibiotic susceptibility of Acinetobacter species or on     the rates of panresistant organisms. The elucidation of potential risk factors for resistant     strains of Acinetobacter is therefore an important task, and the use of alternative     antibiotics should be considered in ICUs where these strains are endemic.   "
199836|NCT00462592|"     The purpose of this study is to compare the effects of 2 weeks therapy of montelukast,     budesonide, their combination on exercise induced bronchoconstriction (EIB) and airway     inflammation in children and young adults, not on regular controller therapy.      Inhaled corticosteroids (ICS) are potent anti-inflammatory agents, which are effective in     controlling and improving all aspects of asthma including the attenuation of EIB. However,     the effect of ICS monotherapy on EIB is comparable if not inferior to the effect of CysLTs     modifiers alone. This may be due to the lack of effect of ICS on the CysLT pathway. As a     consequence, the investigators hypothesize that the combination of ICS and CysLT modifiers     will offer a greater protection against EIB than either therapy alone. The different classes     of drugs may act on complementary pathways believed to be important in the pathophysiology of     EIB.   "
199837|NCT00462605|"     This phase II trial is studying how well giving MS-275 together with GM-CSF works in treating     patients with myelodysplastic syndrome and/or relapsed or refractory acute myeloid leukemia.     MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the cancer. Colony-stimulating factors, such as GM-CSF,     may increase the number of immune cells found in bone marrow or peripheral blood. Giving     MS-275 together with GM-CSF may be an effective treatment for myelodysplastic syndrome and     acute myeloid leukemia   "
199838|NCT00462618|"     The purpose of this pilot study is to assess feasibility and patient accessibility in order     to design an adequately powered study to compare group cognitive behavioral therapy for     insomnia (CBT-I) to quetiapine in non-demented patients aged 60 years or older with     controlled bipolar disorder (I or II) or major depressive disorder who suffer from residual     insomnia.   "
199839|NCT00462631|"     The aim of the study is to compare the efficacy of Paclitaxel-eluting PTCA-balloon dilation     (SeQuentTM Please) followed by cobalt-chromium stent (CoroflexTM Blue) deployment versus     Paclitaxel-eluting stent (TaxusTM LibertéTM) deployment in the treatment of de-novo-stenoses     in native coronary arteries (reference diameter:more then 2.5 mm and below 3.5 mm, length of     stenosis ≥ 10 mm ≤ 20 mm) of patients with diabetes mellitus for ≥ 3 years for procedural     success and preservation of vessel patency.      This study is a prospective, randomized, multi-center, two-armed phase-II pilot study     conducted in Malaysia and Thailand.      128 diabetes mellitus patients shall complete the study per protocol after random assignment     to either of the treatment groups on the order of 20 to 50 patients per center.      Diabetes mellitus patients with stable or selected forms of unstable angina or documented     ischemia due to a de-novo stenosis in a native coronary artery will be enrolled. Vessels may     not supply an entirely infarcted myocardial area.      Late lumen loss at 9 months is the primary endpoint.   "
199840|NCT00462644|"     Trauma patients are at increased risk for adrenal function insufficiency. A commonly used     agent for rapid sequence intubation (RSI) is known to decrease adrenal function. We want to     determine the incidence of adrenocortical insufficiency and its significance during the first     24 hours of resuscitation following RSI in trauma patients.   "
199841|NCT00462657|"     RATIONALE: Studying ways to diagnose fungal infections early may help doctors plan the best     treatment.      PURPOSE: This clinical trial is studying laboratory tests to see how well they find     aspergillosis early in patients at high risk of fungal infection caused by treatment for     hematologic cancer or other disease.   "
199842|NCT00462670|"     To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg     or placebo in congestive heart failure (CHF) patients with extracellular volume expansion     despite the use of a conventional diuretic.   "
199843|NCT00462683|"     The purpose of the study is to evaluate the state of bone health of brain injury patients     being seen within a rehabilitation setting. Osteopenia is a condition of bone in which     decreased calcification, decreased density, or reduced mass occurs. Osteoporosis is a disease     in which the bones become extremely porous, are subject to fracture, and heal slowly. More     specifically, the prevalence of osteopenia and osteoporosis at specific anatomic locations     (e.g., forearms, hips, spine) will be determined as will specific interventions (e.g., use of     vitamins, nutritional supplements, specific prescription medications) that people with brain     injury may be applying, or have applied, to manage their bone health. An attempt will also be     made to evaluate severity of brain injury, based on loss of muscle strength/function, and to     compare this data with bone-focused information such as bone mineral density (BMD), falls,     and history.   "
199844|NCT00462696|"     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in     learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan     better treatment. Drugs used in chemotherapy, such as epirubicin and docetaxel, may stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed.      PURPOSE: This clinical trial is studying MRI in evaluating early response to chemotherapy in     women receiving chemotherapy for infiltrating breast cancer.   "
199845|NCT00462709|"     The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf     for the prevention of acute HAE attacks.   "
199846|NCT00462722|"     The purpose of this study is to determine if the use of ibuprofen blocks the benefits of     exercise to build bone and muscle mass.   "
199847|NCT00462735|"     For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences     and for many patients, improves survival. While combined cisplatin and radiation or cetuximab     and radiation is more effective than radiation alone, approximately 50% of these patients     will still recur. A more aggressive approach may be needed for these patients to prevent     recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given     twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of     patients are cured with this strategy. While cure rates are higher than standard chemotherapy     and radiation and the treatment is tolerable, side effects during treatment are common. We     propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab.     Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.   "
199848|NCT00462748|"     To evaluate the percentage of patients with either established cardiovascular disease (CVD),     at high risk of developing CVD or with diabetes who are on simvastatin 40mg, with fasting     LDL-C > 2mmol/l, who are able to attain the recommended LDL-C target of < 2mmol/l following 6     weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin     10mg.   "
199849|NCT00462761|"     Patients will receive oral AC220 daily for 14 days to study the side effects, tolerability     and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3     status.   "
199862|NCT00462956|"     This study is designed to evaluate the efficacy and safety of GW572016 in patients with     refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must     have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2     overexpressing tumors. Patients eligible for this study must have advanced metastatic breast     cancer who have previously received treatment with anthracycline and taxane.   "
199863|NCT00462969|"     The purpose of this study is to learn fluid from sonohysterography can be used to diagnose     endometrial cancer.   "
199850|NCT00462774|"     Cell transplantation for treatment of heart failure is a novel field of translational     research that offers the perspective of developing curative approaches by regenerating or     rejuvenating lost and/or diseased myocardium and inducing growth of new blood vessels.     Based on the safety and preliminary efficacy testing in previous trials, a stringent efficacy     testing will be performed in this study. Sixty patients who had myocardial infarction in the     past and now need bypass surgery for ongoing coronary artery disease will undergo either     bypass surgery and placebo treatment or bypass surgery and injection of CD133 bone marrow     cells directly in the heart muscle. The study will be fully blinded, i.e. neither the patient     nor the surgeon knows what substance is injected (placebo or cell product). Patients will be     followed for 6 months and various heart function measurements will be performed.   "
199851|NCT00462787|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine, topotecan, vinorelbine, thiotepa,     and dexamethasone, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving more than one drug (combination     chemotherapy) may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when     given together with topotecan, vinorelbine, thiotepa, and dexamethasone in treating young     patients with relapsed or refractory acute leukemia.   "
199852|NCT00462813|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of diindolylmethane, a substance found in cruciferous vegetables, may keep cervical     intraepithelial neoplasia or cervical cancer from forming.      PURPOSE: This randomized phase III trial is studying diindolylmethane to see how well it     works compared to a placebo in treating patients with abnormal cervical cells.   "
199853|NCT00462826|"     This phase II trial is studying the side effects and how well VEGF Trap works in treating     patients with recurrent or persistent endometrial cancer. VEGF Trap may stop the growth of     endometrial cancer by blocking blood flow to the tumor and by carrying tumor-killing     substances directly to endometrial cancer cells.   "
199854|NCT00462839|"     Post-partum hemorrhage (PPH) is defined as blood loss greater than 500 mL after vaginal     delivery. Delayed diagnosis of PPH is a major cause of maternal morbidity and mortality.     Obstetricians estimate blood loss at delivery by visual estimation of blood collected in the     obstetric drapes. Blood is often mixed with urine and surgical sponges. The urine, blood, and     sponges collect in a cone shaped plastic bag that is suspended from the perineum during     delivery. Visual estimation of blood loss is insensitive in diagnosing PPH. In one study     visual assessment of blood loss underestimated postpartum blood loss by 33% to 50% compared     to an objective measurement of blood loss using photospectrometry. Other studies have shown     that the magnitude of underestimation increases as the amount of blood loss is increased. A     limitation of previous studies is that there is no gold standard for blood loss     determination in the third stage of labor. Care providers (obstetricians, anesthesiologists,     and labor & delivery nurses) need to be able to accurately estimate blood loss in order to     better care for mothers and prevent morbidity and mortality. It is unknown whether provider     type or experience (obstetric and anesthesiology resident, fellow, attending physicians, and     nurses) influences the accuracy of blood loss estimation, or whether blood loss estimation     can be improved by providing graduated markings on the vaginal delivery drape.   "
199855|NCT00462852|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients     being treated with gemcitabine for pancreatic cancer.      PURPOSE: This randomized phase II trial is studying how well gemcitabine works with or     without dalteparin in treating patients with locally advanced or metastatic pancreatic     cancer.   "
199856|NCT00462865|"     Women with breast cancer who are not eligible for breast conserving surgery or who have     node-involvement are sometimes treated with chemotherapy up front, in hopes of allowing for a     woman to keep her breast and decreasing the size of the excision for her breast cancer. While     current research has shown that survival is the same whether women are treated with     chemotherapy first or surgery first for breast cancer, the investigators do not yet know how     to treat women with persistent breast cancer after she has received primary chemotherapy.     This study looks at the use of a combination regimen of two agents (gemcitabine and     capecitabine), both of which are active in breast cancer, and using Avastin to see if this     regimen can be given to women treated with primary chemotherapy and then surgery, considered     to be at high risk of relapse.   "
199857|NCT00462878|"     Observational study to compare the treatment in neutropenic patients after allogenic blood     stem cell transplantation, with meropenem or meropenem plus glycopeptide.   "
199858|NCT00462891|"     RATIONALE: Screening may help doctors find breast cancer cells early and plan better     treatment for breast cancer. The Mammography FastTrack program may be effective in increasing     the number of patients who undergo mammography.      PURPOSE: This randomized clinical trial is studying the use of a Mammography FastTrack     program to increase the number of women who undergo mammography.   "
199859|NCT00462904|"     The purpose of this study is to evaluate the safety of a protein called BPI that is naturally     made by the body's white blood cells to fight infection. This study will initially evaluate     an FDA approved investigational dosage and will measure the blood levels over time while BPI     is being infused through a vein to see if the dose is potentially enough to obtain the     desired effect. The drug will be started within 8 hours of burn injury and continued for 48     hours. Patients will be followed on admission and through infusion in the Burn ICU where they     will be monitored by ICU standards. They will be seen regularly thereafter on post-burn days     1, 2, 3, 4, 7, 14 and 28 days while in the hospital. If the patient is discharged prior to     the 28 day evaluation, they will be evaluated on or around the 28th day in the burn clinic. A     blood sample will be obtained to look for potential genetic markers that may increase a burn     patients' risk to develop infection in the post burn period.   "
199860|NCT00462917|"     The purpose of this study is to provide healthy adults with genetic testing and information     about their chances of developing Alzheimer's disease.   "
199861|NCT00462943|"     A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment     of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.   "
199865|NCT00462995|"     2.5 Rationale for preoperative erlotinib therapy      Erlotinib is the only EFGR tyrosine kinase inhibitor to demonstrate a survival advantage and     symptom improvement in a large phase III trial after failure of chemotherapy in advanced     non-small cell lung cancer (Shepherd, Rodrigues Pereira et al. 2005). Although the potential     utility of erlotinib in earlier stage NSCLC is unclear, given its activity in advanced     disease and its minimal toxicity profile, there is likely a subset of patients who may     benefit and potentially be cured by adjuvant erlotinib therapy. Erlotinib may also have     greater antitumour activity in earlier stage disease. Therefore, we propose a phase II study     to assess erlotinib pre-operatively in clinical stage 1 and 2 NSCLC, and downstream effects     on signal transduction pathways and possible markers of treatment resistance and sensitivity.      The proposed study involves administering oral erlotinib for four weeks (28 days)     preoperatively in early stage (1A/B, 2A/B) NSCLC. Current waiting times for surgical     resection of early stage NSCLC at UHN ranges from 4 to 6 weeks (Hui, Johnston et al. 2004),     thus patients would not experience significant delay in time to surgery through this trial     design. This study provides the opportunity to explore the impact of erlotinib on early stage     NSCLC in humans, with pharmacodynamic assessment expected in 100% of patients post-treatment,     in addition to correlative imaging. This study will evaluate the feasibility of preoperative     therapy with erlotinib, and may facilitate the identification of predictive markers for     response to erlotinib in early stage NSCLC. This may help further define the subset of     patients who would benefit from adjuvant EGFR tyrosine kinase inhibitors, and those who may     require other adjuvant approaches including chemotherapy and further clinical trials.   "
199866|NCT00463008|"     RATIONALE: Collecting fluid from a brain tumor using a small catheter may help doctors learn     how much methotrexate gets into the tumor to kill the tumor cells. It may also help doctors     learn how methotrexate works in the brain and in the rest of the body.      PURPOSE: This clinical trial is studying how much methotrexate gets into the brain tumor by     collecting fluid directly from the tumor through a small catheter in patients undergoing     stereotactic biopsy for recurrent high-grade glioma.   "
199867|NCT00463021|"     Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol     (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the     treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.   "
199868|NCT00463034|"     RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with     cancer may help doctors learn more about changes that occur in DNA and help doctors     understand how patients respond to treatment.      PURPOSE: This clinical trial is assessing how changes in genes affect disease progression in     women with newly diagnosed or metastatic breast cancer.   "
199869|NCT00463047|"     Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate     release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic     pain.   "
199870|NCT00463060|"     Cancer is the second leading cause of death in the United States, with approximately 90% of     deaths resulting from patients with metastatic spread. Save for notable exceptions such as     testicular cancer, chemotherapy alone cannot cure patients with metastases. Some patients     with limited metastatic deposits (most commonly colon cancer spread to the liver) can be     cured with surgery followed by chemotherapy. Therefore, some patients with metastases should     be considered for aggressive local therapy (surgery and/or radiation).      Even though chemotherapy has improved significantly, patients treated with conventional     chemotherapy and/or biologically targeted therapy are not cured of their disease. For the     most common types of cancer, chemotherapy alone can shrink or stabilize tumors for an average     of 6 months before the tumors regrow. Both chemotherapy and biologically targeted therapy     have major limitations preventing cure of these patients.      Radiation therapy is an effective modality of treating cancer. Until recently, radiation for     metastases was used only to relieve symptoms resulting from local tumor growth. Technological     advances, including stereotactic radiotherapy, allow for radiation to be more precisely     delivered to the tumor while sparing nearby normal organs. Stereotactic radiotherapy can     completely eradicate local tumors with minimal side effects. Stereotactic radiotherapy has     never been combined with drug therapy. Sutent is a new F.D.A. approved cancer therapy that     targets tumor blood vessels. It is effective against two types of cancer that rarely respond     to chemotherapy (GI stromal tumors and kidney cancer). We propose combining biologically     targeted drug therapy with physically targeted stereotactic radiotherapy. Our goal is to     determine if this is a safe regimen and the best method of combining these treatments.     Ultimately, our goal is to cure some patients with previously incurable metastatic cancer     with this combination.   "
199871|NCT00463073|"     Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The     activity is limited, with an approximately 15 % response rate and a progression-free survival     of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and     the high-level expression of vascular endothelial growth factor on malignant gliomas, one     would expect synergy between bevacizumab and irinotecan against gliomas. In addition, 40-50 %     of GBM have EGFR amplification/mutation making the EGFR an additional target. By combing     cetuximab, with irinotecan and bevacizumab, one would expect further response, than     irinotecan and bevacizumab alone. In addition, recurrent gliomas have an extremely poor     prognosis, so innovative therapies are needed.   "
199872|NCT00463086|"     The purpose of this study is to evaluate whether isoniazid can safely (and further) reduce     the risk of tuberculosis in HIV infected people receiving HAART.   "
199873|NCT00463099|"     The purpose of this study is to determine the effect of modifiable risk factors on knee     function, osteoarthritis, and re-rupture of the anterior cruciate ligament (ACL) following     ACL reconstruction.   "
199874|NCT00463112|"     Studies on the effect of sibutramine, an anti-obesity drug, on hormonal and metabolic     features of women with polycystic ovary syndrome (PCOS) are lacking.      The objective of this study is to examine the effect of sibutramine plus hypocaloric diet on     body composition, hormonal and metabolic parameters and insulin resistance in obese patients     with PCOS.      Overweight and obese women with PCOS were placed in a hypocaloric diet plus sibutramine (10     mg/day) for the first month and then on a hypocaloric diet plus sibutramine (10 mg/day) or     hypocaloric diet only for the subsequent 6 months.      The main outcome measures are: Body composition, hormonal and metabolic features and insulin     sensitivity (OGTT) at baseline, at 3 and 6 months of treatment.   "
199887|NCT00463281|"     Aim of this study is to define a CT-based tissue window for stroke thrombolysis. Our     primary hypothesis is that        1. patients with a tissue window (favourable non-contrast CT (NCCT) scan and an          intracranial occlusion on CT angiography (CTA) or perfusion-CT-mismatch (area of          reduced cerebral blood flow (CBF) > area of reduced cerebral blood volume (CBV))          represent a significant proportion (> 20%)of acute stroke patients and therefore are an          important target group for future interventional studies        2. patients with a tissue window suffer an unfavourable outcome (> 50 % mRS =>4 at 3          months)if the occluded artery was not recanalized.   "
199875|NCT00463125|"     -  Systemic sclerosis (scleroderma; SSc) is a connective tissue disease characterized by a          progressive fibrosis of the skin and visceral organs.        -  A diffuse cutaneous microvascular damage occurs in 30-50% of patients, often leading to          digital ulcers development, responsible for pain, functional disability, disfiguring          scars, digital bony reabsorption, infection and osteomyelitis.        -  Although the availability of drugs as i.v. prostacyclin analogs, oral vasodilating          agents, oral phosphodiesterase-5 inhibitors, oral endothelin receptor blockers has          improved the prognosis, digital ulcers are frequently refractory to the medical          treatment.        -  Preliminary data seems to demonstrate a pivotal role played by some growth factors          (PDGF, TGF beta 1-2, IGF) in the process of ulcers healing: tissue regeneration and          re-epithelization. Alpha-granules in the platelets store these factors in significant          amount.        -  Recently, the application of a gel rich in platelets, prepared from donors’ plasma taken          by apheresis, seems to be beneficial to enhance pressure and vascular ulcers healing.        -  On the basis of these considerations we expect that application of a platelet gel,          combined with advanced dressing and conventional medical therapy, makes a more rapid          healing of digital ulcers in patients with systemic sclerosis. We decided to conduct a          double blind RCT to test this hypothesis   "
199876|NCT00463138|"     Researchers examined perceived satisfaction and perceived increase or decrease in symptoms     among recipients of treatment at the Jerusalem Center for the Treatment of Psychotrauma,     using self report methods. Researchers hypothesized that a significant number of recipients     would report a decrease in their symptoms and general satisfaction with the treatment they     received.   "
199877|NCT00463151|"     The purpose of this study is to examine the safety and efficacy of rebamipide by once daily     intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with     active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).   "
199878|NCT00463164|"     This study aims to investigate the role of fronto-striatal circuits and cognitive control in     the perseverative and inflexible behavior that is a defining feature of autism. We     hypothesize that deficits in the development of fronto-striatal circuitry may underlie     cognitive inflexibility in autism. Specifically, we hypothesize that repetitive, inflexible     behavior arises as (1) fronto-striatal systems are capable of learning patterns present in     the environment (as in implicit learning paradigms), but are unable to adapt behavior to     changing circumstances, related to either (2) decreased ability of basal ganglia to detect     violations of expectancy, (3) decreased ability of prefrontal cortex to respond to detected     violations, or (4) decreased connectivity of the circuits. We are conducting three functional     Magnetic Resonance Imaging (fMRI) studies to address these hypotheses.   "
199879|NCT00463177|"     Chronic, unexplained pain symptoms are very common in all layers of the population, but it is     largely unknown what causes them. This study examines the hypothesis that patients with these     pain symptoms process pain abnormally in their brain. TO this aim, we compare patients and     healthy people: they receive mild pain at their painful body region and at another location.     Concurrently, we measure brain activity with brain scans (functional MRI scans). With our     study results, we want to increase understanding of what causes chronic, unexplained pain     symptoms, in order to find better methods of diagnosing and treating them.   "
199880|NCT00463190|"     Probiotic bacteria inhabit the gastrointestinal tracts of healthy individuals and may improve     the health status of patients with digestive disease. The first aim of our study will seek to     determine if probiotics medication (Bio-Three) inhibit gastrointestinal infection and reduce     its inflammatory response in the intestine. The second aim will explore the bacterial count     (microbiology) and subsequent immune response in probiotic inhibition of enterocolitis in     children. We try to seek to gain an advanced understanding of probiotics versus pathogenic     microorganism and host interactions, and mucosal immune responses to probiotics in the     intestine.   "
199881|NCT00463203|"     Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The     activity is limited, with an approximately 15 % response rate and a progression-free survival     of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and     the high-level expression of vascular endothelial growth factor on malignant gliomas, one     would expect synergy between bevacizumab and irinotecan against gliomas.      Recent data form a small study of 32 patients from Duke University have achieved a response     rate of 62% in patients with malignant gliomas. Most included patients had glioblastomas, but     this regimen may also have activity in more rare primary malignant brain tumors. The     investigators therefore plan to include other primary malignant brain tumors in this study,     and the clinical activity will be correlated with biomarkers and PET results of metabolic     activity and blood flow. This may result in information that can be used to individualize     therapy in the future.   "
199882|NCT00463216|"     The aim of the study is to investigate the possibility that a diagnostic evaluation by a     multidisciplinary team reduces the length of sick leave.   "
199883|NCT00463229|"     As the population ages and the number of stroke survivors increases, information is needed to     determine the best way of providing home care services for rehabilitation to stroke survivors     and their caregivers while containing health care costs. This project will address this area     by developing and testing the effects and costs of a collaborative and specialized team     approach to stroke rehabilitation by health professionals, in a home care setting, compared     to usual home care services. The overall goal of this way of providing home care services is     to improve the quality of life and function of stroke survivors and their caregivers and     prevent future strokes, which will reduce the overall cost to the health care system.   "
199884|NCT00463242|"     This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg     per day and will compare agomelatine and paroxetine tolerability. Eligible patients will     receive double-blind study medication for 8 weeks. One week after completion of the     double-blind treatment phase there will be a single follow-up visit.   "
199885|NCT00463255|"     We investigate whether a change in diet could provide positive effects on general brain     functions in healthy elderly people.   "
199886|NCT00463268|"     The purpose of this study is to evaluate the efficacy of the intermittent administration of     alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for     menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution     treatment.   "
199888|NCT00463294|"     I. Main Research Question:        -  To compare the risks and benefits of Off-pump Coronary artery bypass surgery (CABG) to          On-pump CABG and to determine if one is better than the other.        -  The purpose of this pilot study is also to see the rate of recruitment with          expertise-based randomization across different hospital settings.      II. Small RCT studies and meta-analyses done so far have not been able to conclusively say     which of the procedure is better. A large randomized study is required to establish the risks     and benefits associated with both the off-pump and on-pump CABG surgical procedures.      III. The study will look at which of the two techniques reduce major risks associated with     CABG.   "
199889|NCT00463307|"     The purpose of this study is to evaluate the use of a urine test strip in diagnose     schistosoma mansoni in areas of Kenya where the rate of infections are low.      The hypothesis is that the urine strip test is a superior tool to the conventional     parasitological tools used to diagnose schistosomiasis mansoni infections in area where there     is low transmission   "
199890|NCT00463320|"     This is a two-part study to evaluate the safety, tolerability and pharmacokinetics of single     (Part A) and repeat (Part B) eye drop doses of pazopanib in healthy adult and elderly     subjects.   "
199891|NCT00463333|"     Summary:      Postoperative delirium is a highly prevalent disease (10–30% prevalence) after surgery in     intensive care unit, however, it is often misdiagnosed and mistreated. The aim of the present     project is to investigate risk factors for postoperative delirium in more detail, to evaluate     respective cognitive test systems and to measure EEG activity parallel to patients’ serum     anticholinergic activity. The pathophysiology of delirium is unknown up to now: a possible     dysbalance between cerebral acetylcholine and dopamine concentrations is a likely hypothesis.     Therefore, the measurement of peripheral serum anticholinergic activity could be a new     prognostic factor for evaluation of delirium. Because delirium is also associated with higher     postoperative mortality and morbidity, with delayed functional recovery, and postoperative     delirium makes patient management much more difficult, increases costs, and, above all,     causes severe discomfort to the patient new interdisciplinary diagnostic strategies are     necessary to resolve this problem.   "
199892|NCT00463346|"     The aim of this study is to evaluate the safety and efficacy of acamprosate for patients with     alcohol dependence and comorbid schizophrenia spectrum disorders.        -  1: Relative to placebo, acamprosate will significantly increase cumulative days of          abstinence in recently detoxified alcohol dependent schizophrenia patients measured by          Timeline Follow-Back (TLFB) method.        -  2: Acamprosate will have no significant effect on the psychotic symptoms in          schizophrenia patients with alcohol dependence as measured by the Positive and Negative          Syndrome Scale (PANSS).   "
199893|NCT00463359|"     The purpose of this study is to determine recurrence rates of nodular Basal Cell Carcinomas     on the face removed with curettage and electrodessication (cautery) followed by application     of Imiquimod cream to the base and further to achieve lower recurrence rates than after     treatment with curettage and electrodessication alone.   "
199894|NCT00463372|"     To evaluate the safety and tolerability of multiple doses of PF-02545920 subjects with     schizophrenia or schizo-affective disorder who are currently clinically stable and to     evaluate the serum and urine pharmacokinetics of PF-02545920 and the N-desmethyl metabolite,     PF-01001252, after multiple doses of PF-02545920 administered orally.   "
199895|NCT00463385|"     The purpose of this study is to determine the safety of and to select a treatment regimen of     pomalidomide (CC-4047) either as single-agent or in combination with prednisone to study     further in patients with myelofibrosis with myeloid metaplasia (MMM).   "
199896|NCT00463398|"     From September 2006 a prospective cohort study is conducted among all patients operated at     the Leuven University Fertility Centre to evaluate clinical and economical outcome after CO2     laser laparoscopic fertility surgery.   "
199897|NCT00463411|"     The aim of this study is to identify potential risk factors for fragility fractures in men.   "
199898|NCT00463424|"     The main hypotheses for this study are as follows:        1. The use of NeuFlex implant results in flexion in the fourth and fifth MP joints that is          at least 10 degrees greater than with teh use of the Swanson implant.        2. The use of the NeuFlex implant is associated with a significantly (2.5 kg or more)          greater grip strength than with the use of the Swanson implant.   "
199899|NCT00463437|"     The purpose of this study is to assess the safety in terms of fever (rectal temperature)     higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response     following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of     age in children previously primed with the same vaccines including a pneumococcal conjugate     vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and     meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus     influenzae type b (Hib-MenC) vaccine.      This protocol posting deals with objectives & outcome measures of the booster phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT00334334).   "
199900|NCT00463450|"     The typical menopausal symptoms that are associated with a variety of physical and     psychological changes (e.g. nervousness, anxiety, and depression) and also with impaired     sexual interest and enjoyment are caused by a lack of estrogen, a female sex hormone produced     inside the body. To treat these symptoms, women who are postmenopausal can receive a therapy     called 'hormone replacement therapy' (the dosage of hormones to replace the body's deficient     hormones), for instance, with estrogen preparations injected into a muscle.In women with a     uterus estrogen use causes the lining of the womb (endometrium) to grow (thicken) as before     the menopause. With long-term use this may lead to pathological changes of the endometrium.     That is why this therapy should be complemented by the estrogens' natural counterbalance,     progesterone (progestogen), at a certain interval. This causes the lining of the womb to     shed, with monthly bleeding like a normal period, thus avoiding excessive endometrial     growth.Estrogen treatment is well known to relieve psychological complaints. The combination     of an estrogen with a weak androgen (in this case Dehydroepiandrosterone (DHEA)) is presumed     to clearly increase this effect. The present clinical study is to prove that Gynodian? Depot     as a combination of estrogen and androgen has a better effect on psychological complaints and     sexuality in postmenopausal women than has treatment with the estrogen Estradiol valerate     alone.All patients will receive the same therapy, but differing in sequence. Either they     receive Gynodian? Depot during the first five cycles and the estrogen-only preparation during     cycles 6-10 (treatment group 1) or they receive the study medication in reverse order     (treatment group 2). Patients will be assigned to one of the two groups at random. In either     case they will be given an injection into the gluteal muscle every four weeks.Women with an     intact uterus, in addition to the injections (the day of the injection being the 1st day of a     cycle) have to take a tablet containing 5 mg Medroxyprogesterone acetate (MPA) (progestogen)     per day for 14 days (cycle days 15-28) to enable the endometrium to shed in a monthly     period.The study will extend over a total period of about 11 months, during which the patient     will have 16 appointments for examinations.After patient has signed on the informed consent     form for participation in this clinical study, the investigator will ask her, which diseases     she has at the moment or has had during the past 12 months and which medicinal products she     has been taking. Subsequently, she will have a gynecological examination (including the     breasts) as well as a general physical examination. Blood pressure, heart rate as well as     body height and weight will be measured and noted down. In addition, the doctor will question     her about physical and psychological menopausal complaints by means of two different, short     questionnaires. Only if the evaluation of these two questionnaires shows that she is eligible     for the participation in this clinical study, will the following actions be carried     through.Approx. 40 ml blood will be taken from the patient for a thorough laboratory test     including her hormone levels, and she will be asked for a urine sample. Additionally, she     will have a vaginal ultrasound examination of the womb lining, a cervical smear test (unless     already done during the last three months), and an x-ray examination of the breasts     (mammography) (unless already done during the last 12 months).These measures will be repeated     at Final visit.About 3 weeks after visit 1, when the investigator has the results of all     tests prescribed at visit 1, the patient will be asked to appear for visit 2.If the patient     is eligible for a participation in this clinical study, she will be given the first injection     of the study medication.During the following visits, injections will be given, blood pressure     and pulse rate as well as body weight will be measured and blood will be drawn to measure the     hormone levels.All procedures will apply also during the second treatment period. When     switching to the second treatment period a physical and gynecological examination will     additionally be performed.Questionnaires have to be filled in by the patient at different     time points during the study.   "
199901|NCT00463463|"     High-dose chemotherapy and autologous stem-cell transplantation have an established role in     the treatment of aggressive Non-Hodgkin's lymphoma (NHL) when refractory to first line     chemotherapy or after relapse. The PARMA study randomized 109 patients, with chemo-sensitive     relapse and no marrow involvement to receive, following the initial salvage regimen,     high-dose chemotherapy versus continuous standard dose chemotherapy. 5-year progression-free     survival was 46% in the transplant group compared with 12% in the chemotherapy group. Results     are significantly inferior in patients with multiply relapsed or chemo-refractory disease     with only 0-20% of patients achieving long-term disease control with autologous     transplantation. Thus a large proportion of patients with refractory and relapsing disease     are not cured with currently available transplantation methods and newer approaches are     required.      Rituximab is the first monoclonal antibody approved for clinical use. It is an anti CD20     antibody with high response rate in the treatment of follicular lymphoma and increases     response rate in aggressive lymphoma when combined with chemotherapy. It is well tolerated     with minimal side effects. However tumors may escape rituximab sensitivity by loss of     antigen, poor access of antibody to bulky or poorly vascularized tumors, or failure of host     effectors to eliminate antibody binding tumor cells. Lymphoma cells are inherently and     exquisitely sensitive to radiation. Radioimmunotherapy uses monoclonal antibodies conjugated     with a radioactive isotope to target radiation directly to tumor cells. Ibritumomab is the     parent murine anti CD20 antibody witch targets the same epitope as rituximab. Tiuxetan is a     chelator covalently linked to the antibody which chelates the isotope 90Yttrium to form the     active radioconjugate Zevalin. 90Yttrium is a pure high-energy beta emitter with a relatively     short half time (64 hours) and a path length of 5 mm. These properties make it an ideal     isotope for radioimmmunotherapy. The high energy and long beta path are advantageous in     treating bulky, poorly vascularized tumors, and tumors with heterogeneous antigen expression     as neighboring tumor cells can be hit by cross fire from tumors binding the radioconjugate.     Pure beta emission limits radiation to the patient body and is safe for the surrounding     allowing simple outpatient care, no need for patient isolation or shielding. Biodistribution     is predictable, eliminating the need for dosimetry. Initial studies showed that Zevalin has a     favorable toxicity profile and is more effective than rituximab in patients with follicular     and transformed non-Hodgkin's lymphoma, and studies are currently performed in aggressive     lymphoma.      There are initial phase I-II studies combining radioimmunotherapy with high-dose chemotherapy     and autologous stem-cell transplantation with promising results. We conducted a phase II     study of fixed-dose Zevalin at 0.4 mCi/kg with BEAM high-dose chemotherapy in patients with     chemo-refractory disease. So far, 23 patients were included. With a median follow-up of 17     months the estimated progression-free survival was 52% compared with 0-20% expected in     patients with multiply relapsed and chemo-refractory disease. Based on these data and data     from other groups we expect that the addition of Zevalin to standard high-dose chemotherapy     will improve transplantation outcomes in patients with standard-risk chemosensitive disease,     as well. This study will randomize patients to Zevalin-BEAM versus BEAM alone to determine     the potential of Zevalin radioimmunotherapy to improve outcome of autologous stem-cell     transplantation.   "
199902|NCT00463476|"     Japanese encephalitis virus is the leading cause of viral neurological disease and disability     in Asia. The severity of sequelae, together with the volume of cases, make JE the most     important cause of viral encephalitis in the world. Approximately 3 billion people—including     700 million children—live in areas at risk in Asia for JE. JE most commonly infects children     between the ages of 1 and 15 years, and can also infect adults in areas where the virus is     newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000     to 15,000 deaths. This figure is believed to represent only a small proportion of the disease     burden that actually exists.      An inactivated JE vaccine is currently being used in Sri Lanka. It is given to children in 3     doses, at 12 months of age, 13 months of age, and 2 years of age. A booster dose must also be     given to children at 5 years of age. If Sri Lanka decides to replace the inactivated JE     vaccine with the live attenuated JE vaccine, there will be many children who still need a 3rd     or booster dose of the inactivated JE vaccine. This research study is being done to see if     the live attenuated vaccine will work well to replace the inactivated JE vaccine and if it is     safe in Sri Lankan children.   "
199903|NCT00463489|"     The primary objective of this trial is to evaluate the effect of the addition of a 2 year,     centrally delivered individualized, telephone-based lifestyle intervention focusing on weight     management to a mailed educational intervention on Disease Free Survival in post-menopausal     women with early stage breast cancer (hormone receptor positive), BMI ≥24-<40 kg/m2, who are     receiving standard letrozole adjuvant therapy.   "
199904|NCT00463502|"     Aim: To investigate the effects of metformin treatment on thyroid hormone metabolism in     euthyroid patients with type 2 diabetes mellitus.   "
199905|NCT00463515|"     The aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based     induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is     possible to obtain optimal efficacy with minimal toxicity. Patients will be treated with 3     cycles of induction chemotherapy, unless there is the occurrence of early intrathoracic     progression of disease. The induction chemotherapy is then to be followed by     chemo-radiotherapy.   "
199906|NCT00463528|"     The purpose of this study is to examine the extent of schistosomasis infections in women and     children, their daily activites that encumber contact with water and their knowledge and     attitudes towards the prevention of schistosomiasis.      The hypothesis that will be explored is that women and children spent more time with     agricultural and household activities which bring them in contact with water and therefore     give them an increased risk of being infected by schistosoma. Prevention and control of     schistosomiasis has to be focusing on women and children.   "
199907|NCT00463541|"     To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive     bladder symptoms (urgency, with or without urge incontinence, usually with frequency and     nocturia).   "
199908|NCT00463554|"     The primary objective of this study is to obtain clinical performance information on the     GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) in women with stress     urinary incontinence (SUI).   "
199909|NCT00463567|"     Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of     indacaterol (75, 150, 300 & 600 µg o.d.) in order to select two doses to carry forward into     study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and     tolerability of the selected indacaterol doses in patients with COPD   "
199910|NCT00463580|"     Major depression is increasingly recognized to be a chronic and highly recurrent condition,     which results in significantly increased health problems. One possible mechanism that may     contribute to treatment resistance is increased production and release of chemicals called     proinflammatory cytokines in patients with major depression. These chemicals mediate the     body's response to infectious agents like bacteria and have been shown to be increased by     psychological stress. They produce the symptoms that we associate with being sick, including     fever, malaise and changes in sleep and appetite. Several lines of evidence indicate that     proinflammatory cytokines may contribute to the development of major depression and may thus     represent a novel target for the pharmacological treatment of the disorder.      The TNF-alpha antagonist, Infliximab(Remicade®), is an infusion style drug approved by the     FDA for the treatment of inflammatory conditions like Crohns disease and rheumatoid     arthritis. We are conducting a study to see if the infliximab (Remicade®) is more effective     than placebo in acutely reducing symptoms of depression in patients who have elevated     proinflammatory markers and have not responded to, or been unable to tolerate, at least two     previous treatments in the current depressive episode. Proinflammatory markers are measured     by a simple blood test for C-Reactive Protein(CRP)levels in the body.      After appropriate screening to determine eligibility, 64 subjects with treatment resistant     depression will be randomized to receive three infusions of either infliximab(Remicade®)or     placebo(salt water) in the Emory Infliximab Infusion Center in the Division of Digestive     Diseases, Emory University School of Medicine. Subjects will be followed for 12 weeks with     evaluations at weeks 0 (baseline), 1, 2, 3, 4, 6, 8, 10 and 12. The first     infliximab(Remicade®)infusion will occur at the first (Baseline) visit. The second infusion     will occur at Study Week 2 (the third visit). The third infusion will occur at Study Week 6     (Visit 6). The choice of three infusions, and the infusion schedule, is based on current     recommendations for the use of infliximab(Remicade®)in conditions for which it has received     FDA approval. Subjects will be evaluated for twelve weeks by trained clinicians for changes     in depression symptoms and improvements in quality of life. In addition, a physician will     evaluate subjects each visit to make sure they are remaining healthy. Blood will be withdrawn     at baseline prior to infusion and all subsequent visits to check labs for safety but also to     evaluate potential relationships between changes in inflammatory activity and therapeutic     response. After Study Week 12, participants will be monitored by phone, every 4 weeks during     the 22-Week Post Study Follow-up Phase to assess physical and psychiatric symptoms in the     period following the final infusion. At the baseline and Week 8 visits, subjects will be     admitted to the Atlanta Clinical Translational Science Institute(ACTSI),a research unit in     the Emory Hospital, for an extended evaluation. The purpose of coming to the ACTSI will be     for researchers to evaluate whether treatment with infliximab improves endocrine function,     inflammation, sleep and thinking abilities in people who are depressed. For all other visits     (Week 1, 2, 4, 6, 10 and 12), participants will come for an office visit in the Winship     Cancer Institute.   "
199911|NCT00463593|"     Current efforts to control schistosomiasis and soil-transmitted helminthes infections focus     on the school-age population, and school-based treatment delivery programs offer a major cost     advantages because of the use of the existing school infrastructure and the fact that     schoolchildren are accessible through schools. However, in many developing countries, large     numbers of school-age children are not in school and this has raised questions about the     effectiveness of school-based programs in reaching non-enrolled children. Increasingly, the     non-formal education sector is providing a growing solution to the problem of poor enrolment     in basic education, especially in sub-Saharan Africa, and has recently been used to deliver     praziquantel as part of a national schistosomiasis control program in Uganda. However, it is     unclear how effective this program has been in reaching children who attend non-formal     schools and whether the program has been reaching children from the poorest households.   "
199912|NCT00463606|"     The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin     calcium combination therapy to monotherapy in subjects with dyslipidemia.   "
199913|NCT00463619|"     Follow-Up Study with Retarded Release Phosphatidylcholine in Ulcerative Colitis      Objectives:      The objective of the study is to evaluate the follow up of patients treated with retarded     release phosphatidylcholine in three controlled, randomized studies.      Main question is to investigate whether treatment with phosphatidylcholine could spare     patients the intake of steroids and immunosuppressants without clinical deterioration.      Study population:        -  Retarded release phosphatidylcholine in chronic-active ulcerative colitis.        -  Retarded release phosphatidylcholine in steroid dependent ulcerative colitis.        -  Dose finding study for retarded release phosphatidylcholine      Outcome parameters:      Definition of remission:        1. SCCAI <2,5        2. Likert scale: grade 1 or 2        3. subjective impression of remission: yes/no        4. no blood in stool      Definition of relapse:        1. subjective impression: yes/no        2. SCCAI ≥ 5        3. blood in stool      Definition of low clinical activity: SCCAI < 5      Primary endpoint:      sparing effect of steroids and/or immunosuppressants by rPC in chronic active UC.      Secondary endpoints        1. maintenance of continuous remission        2. improvement of disease activity: a. clinical activity (SCCAI) b.life quality (SIBDQ-D)          c.Likert Score        3. relapse rate: a. time to first relapse b. clinical activity during relapses c. number of          relapses in relation to length of treatment   "
199914|NCT00463632|"     Cross-sectional study of prevalence and intensity of schistosome infection in pregnant women,     follow-up into postpartum, and the association of schistosome infection with haemoglobin     concentration, compared to a group of non-pregnant women.   "
199915|NCT00463645|"     This is a mono-centre trial performed at the medical ICU at the Medical University Graz.     There will be a study visit (V1) and a follow-up assessment (V2). In the study visit (V1)     arterial blood glucose values will be monitored and subcutaneous sampling of interstitial     fluid (ISF) with microdialysis for glucose determination and with microperfusion for     cytokine-measurement will be performed. The study visit will last for 26 hours starting with     the insertion of two catheters in the abdominal subcutaneous tissue (one microdialysis- and     one microperfusion catheter). The primary hypothesis of the study is: Interstitial fluid     glucose concentration profiles correlates to the arterial blood glucose concentration profile     in patients with severe sepsis in the medical ICU.   "
199916|NCT00463658|"     With an aging population, an associated increase in the number of falls and fall injuries,     there is a need to examine how health care services, such as home care, can best prevent     falls among older people. This project will directly address this area by evaluating the     effects and expense of an innovative approach to home care service delivery for older people     at-risk for falls.   "
199958|NCT00464217|"     To reproduce or to improve the index of complete responses of protocol LMA-91 with a similar     protocol, decreasing the dose of Idarubicin to try to reduce the deaths in induction   "
202058|NCT00492492|"     Treatment of extension fractures of the distal radius : prospective randomized postoperative     comparison between trans-styloid and intrafocal pinning on the one side and volar fixed-angle     plating on the other side.   "
199917|NCT00463671|"     Hyperbaric oxygen therapy (HBOT) increases tissue oxygenation and serves as an adjunct     therapy for diabetic wounds. However, some patients have insufficient increase or even     paradoxical decrease in tissue O2 due to vasoconstriction. The aim of the present study was     to investigate the pathophysiology responsible for the different consequences of HBOT and to     evaluate the effect of N-acetylcysteine (NAC) on these changes.      Methods: Prospective, randomized, cross-over trial including fifty diabetic patients with     non-healing ulcers. All patients had two HBOT (100%oxygen, 2ATA) with NAC at the first or the     second evaluation. At the beginning and at the end of each evaluation, ulcer oxygenation and     plasma levels of malondialdehyde (MDA), total anti-oxidant status (TAOS) and nitric oxide     (NO) were measured. Patients with ulcer oxygenation above 200mmHg, were subjected to complete     HBOT protocol.   "
199918|NCT00463684|"     Japanese encephalitis virus is the leading cause of viral neurological disease and disability     in Asia. The severity of sequelae, together with the volume of cases, make JE the most     important cause of viral encephalitis in the world. Approximately 3 billion people—including     700 million children—live in areas at risk in Asia for JE. JE most commonly infects children     between the ages of 1 and 15 years, and can also infect adults in areas where the virus is     newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000     to 15,000 deaths. This figure is believed to represent only a small proportion of the disease     burden that actually exists.      Data from a previous trial, also sponsored by PATH and conducted by investigators in the     Philippines, indicate that there was no immunologic interference between Japanese     encephalitis live attenuated SA 14-14-2 vaccine and measles vaccine when administered at the     same time. Additionally, the safety profile of the coadministered vaccines was the same as     for the vaccines administered separately. This research study, to be conducted among infants     in Sri Lanka, is being done to confirm the Philippines trial results.   "
199919|NCT00463697|"     This study will involve the use of a new compound, GW642444 that is being developed for the     treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on     cells in the lungs, causing some of the muscles around the lungs to relax and open up better     (bronchodilation), making breathing easier. When a medicine is made into a form ready to be     given to patients, the active ingredient is often prepared with another ingredient called a     salt to help make it stable, and inactive ingredients are often added. Inactive ingredients     might be used to help a medicine work better, to make it easier to produce the medicine, or     to make it easier to get an accurate dose of medicine. In previous studies the study drug has     been given as a dry powder containing either the H salt (with the inactive ingredient     lactose), or containing the M salt (with the inactive ingredients lactose and cellobiose     octaacetate). The M salt form of the study drug has been altered to contain lactose and a     new inactive ingredient called magnesium stearate (instead of cellobiose octaacetate).      Participants in this study will receive both the H salt (GW642444H) and the new M salt     (GW642444M) containing magnesium stearate. This study will be the first time the new M salt     form of the study drug will be given to asthmatic patients.   "
199920|NCT00463710|"     Phase IV open label, single-blind study, post-marketing, 1-year MRI observational study     evaluating effect of Avonex® monotherapy (6.0 MIU administered i.m. each week) on the     year-to-year changes in two annual measures—magnetization transfer imaging and     diffusion-weighted imaging in patients with either relapsing-remitting (RR) or     secondary-progressive (SP) multiple sclerosis (MS). One hundred fifty (150) patients with RR     and SP MS—followed at the Jacobs Neurological Institute, University at Buffalo, Buffalo     NY—who satisfy both inclusion and exclusion criteria will be included. They will be assessed     at baseline and at 12 months with MRI and clinical examinations.   "
199921|NCT00463723|"     Background: Patients following allogeneic keratoplasty are treated with topical and     frequently with systemic steroids to prevent immune reactions. Steroids are known to yield     good results, but exert a wide range of side effects. The efficacy of topial FK506 in     preventing immune reactions has already been demonstrated experimentally. FK506, an     IL-2-inhibitor like Cyclosporin A (CSA), is known to be approximately 100 fold more potent     than CSA. Aim of the study: In this study the efficacy and safety of topical FK506 will be     compared to our standard treatment (i.e. steroids) after penetrating normal-risk     keratoplasty.   "
199922|NCT00463736|"     Study compares the outcomes of women between 26 and 32 wks gestation with rupture of     membranes. Women randomized to receive tocolysis with magnesium sulfate x 48 hrs or placebo     of saline IV x 48 hrs. Antibiotics and antenatal steroids given to both groups.   "
199923|NCT00463749|"     Acetylcystein is a potent antioxidans which is able to prevent contrast dye induced     nephropathy in stable patients undergoing additional hydration.      In primary percutaneous intervention for infarction hydration is not possible. Therefore     Acetylcystein might prevent contrast dye induced nephropathy.      Furthermore, it might reduce infarct size as a result of its antioxidant properties.      Clinical trials are missing so far examining the effects of Acetylcystein on nephropathy and     infarct size.   "
199924|NCT00463762|"     The primary objective is to collect data on treatment outcomes (clinical and microbiological     cure), safety and tolerability of treatment with cefoperazone/sulbactam in patients with     serious intra-abdominal and hepatobiliary infections in Slovakia.   "
199925|NCT00463775|"     The objective of the present study is to evaluate the efficacy of topiramate (250mg/day)     versus placebo in decreasing aggression and reducing alcohol consumption in patients with     borderline personality disorder (BPD) and alcohol dependence (AD).   "
199926|NCT00463788|"     The primary objective of this study is to determine whether overall response to cetuximab     combined with cisplatin is better than overall response to cisplatin alone together with     showing that the overall response for cetuximab and cisplatin was above a pre-specified     threshold of 0.2 in the treatment of triple negative metastatic breast cancer.      The secondary objective of this study is to compare the differences between the two treatment     groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival     (OS), Time to Response (TTR) and Safety.   "
199927|NCT00463801|"     This study will evaluate the safety and efficacy of daptomycin against complicated skin and     skin-structure infections in adults   "
199928|NCT00463814|"     The primary purpose of the study is to assess the safety, tolerability and pharmacokinetics     of a capsule of AZD6244 in patients with advanced solid malignancies.   "
199929|NCT00463827|"     Asthma is a chronic inflammatory condition of the lungs.      There is evidence that cigarette smoking can make asthma symptoms worse and that smokers with     asthma do not respond as well to standard therapies as non-smokers.      Statins are drugs which are already used to lower cholesterol. They have also been shown to     have some anti-inflammatory properties.      In this trial the investigators will give a randomised group of smokers Atorvastatin and the     remaining group a placebo or blank tablet. The investigators will then monitor patients'     responses in terms of peak flow data, symptom diaries, questionnaires and breathing tests.   "
199930|NCT00463840|"     The intention of this trial is to determine the maximum tolerated of the treatment     combination and to evaluate its safety and efficacy.   "
199931|NCT00463853|"     The purpose of this study is to determine whether it is safe to receive an injection of your     own bone marrow adult stem cells (autologous BM-MNC) to your heart wall during coronary     artery bypass graft (CABG).   "
199932|NCT00463866|"     The purpose of this study is to evaluate the effect of two different maintenance doses of     Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month     treatment period   "
199933|NCT00463879|"     The purpose of this study is to determine the acute effects of the nicotinic receptor     allosteric modulator galantamine (0, 4 and 8 mg) on neurocognitive function in schizophrenic     smokers (n=20) versus schizophrenic nonsmokers (n=10) in an outpatient human laboratory     setting.   "
199934|NCT00463892|"     The study is designed to see if a high-resolution MRI scan of lymph node areas near where a     melanoma has been removed from the skin can pick up the spread of melanoma to those lymph     nodes with a high degree of accuracy.   "
199935|NCT00463905|"     Postmenopausal women with vertebral fractures (VFs) represent an important target for     secondary fracture prevention, but few of these patients come for clinical attention. Recent     evidence suggests that screening postmenopausal women for clinical risk factors like height     loss and fracture risk identifies those at high risk of prevalent VFs who should be referred     for diagnostic X-rays, a strategy which is likely to prove cost effective. However, before     being applied at a United Kingdom (UK)-wide level, it needs to be established that use of     this strategy improves secondary fracture prevention, and that these benefits are achieved in     a cost-effective manner. To examine these questions, a randomised-controlled-trial will be     performed in which women aged 65-80 from general practitioner (GP)-practices in the     intervention group will be invited for risk factor assessment, followed by referral for     thoracolumbar X-ray where appropriate. The primary outcome will be a change in bisphosphonate     or other drug prescribing between the intervention and control arms after six months.   "
199936|NCT00463918|"     This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of     two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at     least three cigarettes per day.   "
199937|NCT00463931|"     Schistosomiasis and soil-transmitted helminhtiasis occur throughout the developing world and     are most prevalent in the poorest communitites. These worms have been linked to several     nutritional and intellectual deficiencies in many endemic populations worldwide. Helminth     control, though crucial has been neglected for varied reasons. Currently, interests towards     the control of neglected diseases including schistosomiasis and soil-transmitted helminths     has been revived through many interventions including repeated chemotherapy to help improve     public health outcomes and prevent long term morbidity. This will contribute to achieving     several of the Millennium Development Goals at a favourable cost. A community-directed     treatment of human schistosomiasis and STH in school-aged children in rural notrhern Ghana     using praziquantel and albendazole is proposed. It is planned to test the hypothesis that     community-based volunteers are non-inferior and more cost effective than rural school     teachers at reaching school-aged children.   "
199938|NCT00463944|"     A study of an electronic voting system as a learning aid during tutorials   "
199939|NCT00463957|"     Sildenafil and similar drugs have been used for several years to treat erectile dysfunction.     It has been noticed that in some people, sildenafil causes a subtle increase in the length of     time that visual images that we see are retained by the retina. It is thought that this might     be due to an effect of sildenafil on inhibiting an enzyme called phosphodiesterase type 6     (PDE6) which is present in the retina. By giving single oral doses of sildenafil and a     similar drug called tadalafil which has less effect on PDE6, we hypothesise that this is the     mechanism of the change in vision caused by sildenafil. By performing computerised visual     test, we plan to compare the effects of sildenafil, tadalafil and placebo tablets on vision     in healthy volunteers.   "
199940|NCT00463970|"     CINS is a large multicentre study which aims to test out the effect of 4 different     interventions, namely a brief cognitive intervention (BI), a more extensive cognitive     behavioural intervention (CBT), and 2 different nutritional supplementations (seal oil and     soy oil) in a population of chronic low back pain patients sicklisted for 2-10 months.   "
199941|NCT00463983|"     Octreotide is a somatostatin analog with a long half-life in vivo. Octreotide has interesting     anti-inflammatory and anti-fibrotic properties in vitro and in vivo. Somatostatin receptors     are increased and Octreotide uptake is increased in the lung in patients with idiopathic     pulmonary fibrosis. Our hypothesis is that octreotide may slow the degradation of lung     function in patients with IPF. In this proof of concept study, patients with IPF will receive     an intramuscular injection of slow release octreotide (Sandostatin LP, 30 mg)every 4 weeks     for 48 weeks. Lung function (FVC, DLCO), HRCT scores for fibrosis and ground glass, 6 minute     walking test,quality of life and survival will be monitored.   "
199942|NCT00463996|"     Can MRI be used to stage ovarian cancer?   "
199943|NCT00464009|"     This study aimed to evaluate the effect of three forms of continuing medical education (CME)     on provision of preventive dental services to Medicaid-enrolled children by medical personnel     in primary care physician offices.   "
199959|NCT00464230|"     An estimated 1.6 million patients sustain a hip fracture every year, about half of these are     intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for     any patient, and the risk of disability, increased dependence and death is substantial. The     main treatment options for displaced femoral neck fractures are internal fixation and     arthroplasty. It is established that there are more complications and reoperations after     internal fixation, but there is no consensus about which procedure that gives best functional     results.   "
199944|NCT00464022|"     Double-balloon enteroscopy (DBE) is a novel endoscopic procedure for visualising the entire     small bowel. In any GI endoscopy procedure it is mandatory to insufflate gas into the bowel     to secure good visualisation. All endoscopes used for GI endoscopy provide a gas insufflation     unit. Currently, air is used for this purpose in more than 90% of centres throughout the     world. The use of air, however, is far from ideal to use for insufflation in GI endoscopy.     After GI endoscopy, significant amounts of air are usually retained in the bowel segment     inspected (5). This air has to pass the GI tract and exit physiologically through the rectum.     Thus, abdominal pain and discomfort during and after the examination due to the retention of     air has been shown to be very common during and after endoscopic procedures (5-9).      Carbon dioxide gas (CO2), unlike air, is rapidly absorbed from the bowel. Within minutes,     several litres of CO2 can be absorbed from the GI tract. The use of CO2 has been shown to     result in more comfortable examinations in both colonoscopy and flexible sigmoidoscopy in     several randomised trials (6-9). In these studies, CO2 insufflation almost completely reduced     procedure-related pain and discomfort.      To our knowledge, no research has been performed investigating the use of CO2 in DBE. DBE is     a long-lasting procedure (mean examination time 75 minutes (4)). Large volumes of air are     insufflated during the procedure, leading to significant distension of the small bowel during     and after the examination.      One of the main technical difficulties in DBE is the formation of small bowel loops and scarp     angels during deep intubation of the endoscope. These loops and angels are the major     restriction to deep intubation of the endoscope. Loops and scarp angels are more pronounced     in air-distended bowel segments.      The aim of the present study is to examine whether CO2 insufflation leads to a reduction of     abdominal pain in DBE patients. Furthermore, we want to investigate if CO2 insufflation     facilities a deeper intubation of the endoscope and thus a more complete examination of the     small bowel mucosa.      The study is designed as a two-centre randomised controlled trial. Randomisation to the two     treatment groups (CO2 or air insufflation) is performed on basis of the individual     participant.   "
199945|NCT00464035|"     The purpose of this study is to investigate the effect of calcium on postprandial lipid     profile and appetite.   "
199946|NCT00464048|"     We will evaluate the effect of a short-term aerobic exercise program as an adjuvant treatment     in patients with depression undergoing standard clinical antidepressant medication therapy as     compared to the effect of stretching exercise. In addition, the effect of exercise on plasma     biological markers will be examined and observed changes correlated with clinical     antidepressant effects. We hypothesize that the aerobic exercise group will achieve a     significantly higher response rates of depressive symptoms, will also have a greater degree     of change in the plasma markers, than the control stretching group.   "
199947|NCT00464061|"     The purpose of this study is to assess efficacy and safety of volinanserin in the population     of patients complaining of sleep maintenance insomnia. The objective of the substudy is to     assess glycemic control in the subgroup of patients with type II diabetes mellitus.   "
199948|NCT00464074|"     This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in     patients with relapsing forms of MS.   "
199949|NCT00464087|"     The primary objective of this clinical trial is to evaluate safety of switching from     fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute     coronary syndrome undergoing percutaneous coronary angioplasty.   "
199950|NCT00464100|"     We believe that how a baby with Hypoplastic Left Heart Syndrome (HLHS)does after a major open     heart operation, measured by things like blood pressure, oxygen saturation, heart rate and     others, may have an impact on development. Studying how post-operative condition impacts     outcomes may help us to protect babies better when they undergo surgery.      This study will look at some of the long-term outcomes of children with HLHS, including both     mental development and quality of life. We will use information from your child's medical     record to see if early oxygen delivery has an impact on later development.   "
199951|NCT00464113|"     The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how     often it should be taken, and how well people with leukemia tolerate XL228.   "
199952|NCT00464126|"     The purpose of the study is to help determine if either crystalloid solution or colloid     solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac     patients.   "
199953|NCT00464139|"     At the Leuven University Fertility Centre (LUFC) of the Department of Obstetrics and     Gynecology of the University Hospitals Leuven, Belgium, a retrospective epidemiological     prevalence study based on an electronic search of patient files was performed to determine     the prevalence of histologically proven endometriosis in a subset of infertile women with a     regular cycle (variation 21 - 35 days), a partner with normal sperm and no previous surgical     diagnosis of endometriosis.   "
199954|NCT00464165|"     The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo     on abstinence from tobacco use in cigarette smokers.      The secondary objective is to evaluate the effects of rimonabant on craving and weight and on     the clinical and biological safety and tolerability of rimonabant in a population of     cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of     abstinent subjects during a 40-week follow-up post treatment.   "
199955|NCT00464178|"     The purpose of this study is to determine whether the combination of bevacizumab and     bortezomib have increased efficacy in the treatment of relapsed/ refractory multiple myeloma.   "
199956|NCT00464191|"     Funding: An investigator-initiated trial funded by H. Lundbeck AS.      Study design: Prospective, randomised, placebo-controlled parallel-group multicenter study.      Aim: To investigate efficacy and side effects (especially mood switches) of escitalopram,a     selective serotonin reuptake inhibitor, in the acute and maintenance treatment of bipolar     depression.      Hypotheses:        1. Escitalopram, given in addition to mood stabilising medications, is significantly more          efficacious, measured by response and remission rates than placebo in bipolar depression          (the acute phase study).        2. Continuation therapy with escitalopram gives significantly longer mean time to          depressive relapse and fewer depressive relapses compared to placebo (the continuation          study).        3. The incidence of mood switching (defined as development of mixed episodes, mania, or          hypomania according to DSM-IV criteria) do not differ significantly between escitalopram          and placebo in either the acute or the continuation phases.      Patients: In- and outpatients receiving care in the specialised psychiatric services of     Western Norway. The population is intended to be representative of the patients treated for     bipolar depression in ordinary specialist care. Patients must have a MADRS score of at least     20 at baseline. Patients with ongoing substance abuse or dependence, organic mental illness,     and non-affective psychotic symptoms are excluded.      Medication: Escitalopram 10-20 mg daily or placebo in addition to mood stabilisers. The dose     of mood stabilisers must have been constant for the last six weeks prior to randomisation.      Method: Phase 1 is a eight-week acute treatment trial with six clinical assessments. Patients     treated with escitalopram who have not responded after eight weeks (defined by at least 50%     reduction of MADRS score compared to baseline) leave the study. Placebo non-responders are     treated openly with escitalopram and repeat phase 1. Responders are re-randomised to 32 weeks     of maintenance treatment (phase 2). Phase 2 has nine clinical assessments. Patients who     develop hypomania, mania or depressive episodes (defined as episodes meeting DSM-IV criteria     for Major Depressive Episode with MADRS scores of at least 20 points) leave the study in this     phase. Patients leaving the study prematurely will be offered alternative treatment.   "
199957|NCT00464204|"     The rapidity and the quality of fluid resuscitation in patients with severe sepsis are     important factors for the prevention of secondary multi-organ failure. Vascular filling may     also have an impact on tolerability of enteral nutrition. The earliness and quantity of     calories provided by enteral nutrition may have an impact on morbidity and mortality. This     study will asses the effects of volume expansion on hemodynamics and tolerability of enteral     nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly     safety data of the study.   "
199960|NCT00464243|"     The purpose of this study is to assess efficacy and safety of volinanserin in the population     of patients complaining of sleep maintenance insomnia. The patients suffering from that     condition frequently wake up during the night, their sleep is non restorative and they suffer     from a significant distress or impairment in their daily activities consecutive to insomnia.   "
199961|NCT00464256|"     The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus     placebo on abstinence from tobacco use in cigarette smoker.      The secondary objective is to evaluate the effects of rimonabant on craving and weight and on     the clinical and biological safety and tolerability of rimonabant in a population of     cigarette tobacco smokers during a 10-week treatment period.   "
199962|NCT00464269|"     This study will evaluate the efficacy and safety of Brivaracetam to support the submission     file in the indication of adjunctive treatment in adolescents and adults with partial onset     seizures.   "
199963|NCT00464282|"     Objective: L-[3-18F]-α–methyltyrosine (FMT) is an amino-acid tracer for PET. We evaluated the     diagnostic usefulness of 18F-FMT PET in non-small cell lung cancer (NSCLC) patients. Tumor     uptake of 18F-FMT PET was compared with 18F-FDG PET and the correlation with L-type amino     acid transporter 1 (LAT1) expression also investigated.      Method: Fifty patients with NSCLC were enrolled in this study, and a pair of PET study with     18F-FMT and 18F-FDG was performed. LAT1 expression and Ki-67 labeling index of the resected     tumors were analyzed by immunohistochemical study.   "
199964|NCT00464295|"     In patients with unresectable/advanced Hepatocellular Carcinoma receiving Capecitabin, we     anticipate that the proposed chemotherapy will have a delay in progression of the disease .     It is also expected that proposed chemotherapy will have acceptable toxicity and Quality of     life.   "
199965|NCT00464308|"     The primary objective of this study is to compare, the number of patients with heartburn and     regurgitation symptom resolution after treatment with either rabeprazole 20 mg, esomeprazole     20 mg or esomeprazole 40 mg.   "
199966|NCT00464321|"     This study will investigate whether GC1008, an antibody which neutralizes TGF-beta, is safe     in treating patients with the disease called focal segmental glomerulosclerosis (FSGS). The     highest dose without excessive side effects will be investigated. Tests will determine how     long GC1008 is in the body and how it is excreted.   "
199967|NCT00464334|"     The purpose of this study is to test the safety, tolerability and the immune response to an     investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).   "
199968|NCT00464347|"     VERTACL will investigate whether a triple therapy, Avastin®, half fluence verteporfin     photodynamic therapy (PDT), and triamcinolone acetonide-preservative free (TAC- PF), results     in improved 12-month vision outcome compared to Avastin® alone in participants with     neovascular AMD.   "
199969|NCT00457938|"     Lipodystrophies represent a therapeutic challenge with regards to the management of the     diabetes, insulin resistance, hypertriglyceridemia and fatty liver which frequently present     in conjunction with significant adipose tissue loss. The purpose of the study and it's four     subprojects is to examine the safety and efficacy of various novel interventions designed to     improve or resolve the fatty liver, hypertriglyceridemia, and insulin resistance or diabetes     that is seen in these patients.   "
199970|NCT00457951|"     The purpose of this study is to determine whether ODSH, when added to conventional treatment,     is more effective in treating COPD exacerbations than conventional therapy alone.   "
199971|NCT00457964|"     The purpose of this research study is to find out what effects RAD001 has on angiomyolipomas     of a person with Tuberous Sclerosis Complex and to determine the safe dose of RAD001 without     toxicity.      The hypothesis is that the drug will inhibit the growth of the angiomyolipomas and possibly     even cause regression.   "
199972|NCT00457977|"     Pneumococcal disease is a serious bacterial infection that can affect different parts of the     body, including the lungs. People with chronic illnesses, such as chronic obstructive     pulmonary disease (COPD), have a greater risk of developing pneumonia and meningitis as a     result of pneumococcal disease. This study will compare the immune response to two types of     pneumococcal vaccines in adults with COPD.   "
199973|NCT00457990|"     Background: Iron deficiency in early childhood may impair neurodevelopment.      Aim: To examine whether early iron supplementation improved neurodevelopment in preterm     infants.      Method: Children who participated in a clinical trial of iron supplementation were invited     for a neurodevelopmental follow-up examination at the time of school entry.   "
199974|NCT00458003|"     Hypotension remains a common clinical problem after induction of spinal anesthesia for     cesarean delivery. Maternal hypotension has been associated with considerable morbidity     (maternal nausea and vomiting and fetal/neonatal acidemia). Traditionally, ephedrine has been     the vasopressor of choice because of concerns about phenylephrine's potential adverse effect     on uterine blood flow. This practice was based on animal studies which showed that ephedrine     maintained cardiac output and uterine blood flow, while direct acting vasoconstrictors, e.g.,     phenylephrine, decreased uteroplacental perfusion. However, several recent studies have     demonstrated that phenylephrine has similar efficacy to ephedrine for preventing and treating     hypotension and may be associated with a lower incidence of fetal acidosis. All of these     studies have been performed in healthy patients undergoing elective cesarean delivery.      Preeclampsia complicates 5-6% of all pregnancies and is a significant contributor to maternal     and fetal morbidity and mortality. Many preeclamptic patients require cesarean delivery of     the infant. These patients often have uteroplacental insufficiency. Given the potential for     significant hypotension after spinal anesthesia and its effect on an already compromised     fetus, prevention of (relative) hypotension in preeclamptic patients is important. Spinal     anesthesia in preeclamptic patients has been shown to have no adverse neonatal outcomes as     compared to epidural anesthesia when hypotension is treated adequately. Due to problems     related to management of the difficult airway and coagulopathy, both of which are more common     in preeclamptic women, spinal anesthesia may be the preferred regional anesthesia technique.     Recent studies have demonstrated that preeclamptic patients may experience less hypotension     after spinal anesthesia than their healthy counterparts. To our knowledge, phenylephrine for     the treatment of spinal anesthesia-induced hypotension has not been studied in women with     preeclampsia. The aim of our study is to compare intravenous infusion regimens of     phenylephrine versus ephedrine for the treatment of spinal anesthesia induced hypotension in     preeclamptic patients undergoing cesarean delivery. The primary outcome variable is umbilical     artery pH.   "
199975|NCT00458016|"     The purpose of this study is to collect important information regarding the safety,     tolerability, and efficacy of MB07803 when administered for 28 days in patients with type 2     diabetes mellitus   "
199976|NCT00458029|"     HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across     the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at     start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the     schools were randomized to receive an intervention that integrated four components: the     school nutrition environment, physical education class activities, behavior change     initiatives, and educational and promotional communications activities.   "
199977|NCT00458042|"     The purpose of this study is to compare the effects of switching from inhaled Ventavis to     intravenous Remodulin in PAH patients who are considered to be failing inhaled Ventavis     therapy. This study is intended to provide information on the safe transition from Ventavis     to Remodulin as well as the impact intravenous Remodulin may have on overall quality of life     and treatment satisfaction compared to Ventavis.   "
199978|NCT00458055|"     A low level of plasma high-density lipoprotein (HDL) cholesterol, the good cholesterol, is     the most common lipid abnormality observed in patients with a premature atherosclerotic     cardiovascular disease. HDL carry excess cholesterol from peripheral tissues to the liver to     be metabolized or excreted, a process known as reverse cholesterol transport.      Epidemiological studies have shown an inverse correlation between plasma levels of HDL     cholesterol and the risk of cardiovascular disease. An increase in plasma HDL cholesterol     levels by 1 mg/dL may reduce the risk of cardiovascular disease by 2 to 3%. The standard care     of treatment for a low level of HDL cholesterol is: 1) lifestyle modifications including     exercise, smoking cessation, weight control, moderate alcohol intake and decreased dietary     fat intake - all patients are encouraged to follow these lifestyle modifications; 2)     medications which can raise HDL cholesterol.      Currently used medications to treat lipid disorders can increase, in some extent, HDL     cholesterol. These include niacin (vitamin B3), fibric acid derivatives (fibrates) and     statins. However there is no data on the effect of these medications on severe cases of HDL     deficiency. This project aims to determine whether currently available medications, used in     standard medical practice for the treatment of lipoprotein disorders, can substantially     increase HDL cholesterol in severe cases of HDL deficiencies.   "
199979|NCT00458068|"     Background: Preterm infants are at risk of iron deficiency. The smaller the infants are at     birth, the smaller the iron stores at birth and the higher the risk of iron deficiency.      Hypothesis: Preterm infants with a birth weight of less than 1301g require iron     supplementation earlier than previously recommended.      Methods: Prospective randomized controlled clinical trial (1996-1999). Results: Early iron     supplementation may reduce the incidence of iron deficiency and the need for late blood     transfusions.   "
199980|NCT00458081|"     Primary objective:        -  To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg          versus a placebo during a 12 month period.      Secondary objectives:        -  Percentage of patients in both arms of the study whose levels of microalbuminuria          decrease, stabilise, increase towards macroalbuminuria or are unchanged after 12 months          of treatment with rimonabant or placebo.        -  To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month          period on:             -  Weight and waist circumference.             -  Glycaemia profile: fasting glycaemia, fasting insulinaemia and HbA1c.             -  Lipid and lipoprotein profile: triglycerides, total cholesterol, HDL-C, LDL-C,               apolipoproteins A1 and B.             -  Inflammatory markers             -  Adipocytokines.             -  Blood pressure.             -  Glomerular filtration rate.        -  To assess the quality of life by means of questionnaire filled in.        -  Safety parameters   "
199981|NCT00458094|"     This study will determine the effectiveness of a peer support system in increasing physical     activity and effecting health behavior change in people with serious mental illnesses.   "
199982|NCT00458107|"     This study is being conducted to evaluate the safety and tolerability of ascending multiple     oral doses of SCA-136 adminstered to healthy Japanese and non-Japanese female subjects.   "
199983|NCT00458120|"     Dengue fever, which is caused by dengue viruses, is a major health problem in subtropical     regions of the world. There are four different forms (serotypes) of dengue virus that can     cause dengue fever. The purpose of this study is to determine the safety and immune response     to a vaccine containing a particular dengue serotype when an individual has been previously     vaccinated with a different dengue serotype.   "
199984|NCT00458133|"     The goal of the proposed study, Health Benefits of Aerobic and Resistance Training in     individuals with type 2 diabetes (HART-D), is to compare the effect of resistance training     alone (RT), resistance in combination with aerobic training (AT+RT), and aerobic training     alone (AT) to standard care (SC) on hemoglobin A1C (HbA1C), in initially sedentary women and     men with type 2 diabetes (T2D).   "
199985|NCT00458146|"     The purpose of this study is to determine whether MM-093 is safe and effective in the     treatment of RA.   "
199986|NCT00458159|"     A Phase I, Open-Label, Dose-Escalation Study of CC-11006 In Subjects With Low- or     Intermediate-1 Risk Myelodysplastic Syndromes.   "
199987|NCT00458172|"     This study is the second empirical investigation in a series of studies, examining what     everyday people believe that it means to be healthy. Part of this research also involves     examining whether these lay theories of health vary according to various demographic     classifications.   "
199988|NCT00458185|"     This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis     (AS).   "
199989|NCT00458198|"     This study will determine the effectiveness of integrated behavior therapy in treating     children with selective mutism.   "
199990|NCT00458211|"     Because ziprasidone has not been extensively studied and is not widely accepted in the     severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and     relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who     need a change of medication because of ineffectiveness or side effects will be changed to     ziprasidone and followed with detailed assessments for eight weeks.      The hypothesis is that they will improve and have fewer side effects.   "
199991|NCT00458224|"     In the county of Oppland, Norway, questionnaires addressing physical and mental health and     socioeconomic status is issued to all (1960) families who meet for the pre-school assessment     at the public health clinics in 2007. Particularly growth, physical activity and diet is     addressed.      Families who have children with a BMI >18.9, which corresponds to BMI>30, and living in     selected municipalities in the county are invited to participate in a 5 year intervention     program in order to avoid future overweight conditions in children. Similarly overweight     children from the rest of the county serve as controls.   "
200292|NCT00473577|"     To determine the maximum tolerated dose (MTD) of CRA-024781 IV given by 2-hour intravenous     infusions in patients with refractory solid or hematologic malignancies. To evaluate safety     and tolerability, pharmacokinetics and pharmacodynamics, and to evaluate bioavailability of     CRA-024781 IV when administered in a single oral dose.   "
199992|NCT00458237|"     The purpose of this research study is to determine the safety of RAD001 and the highest dose     of this drug that can be given to people with HER2-positive metastatic breast cancer safely     in combination with trastuzumab. RAD001 has been used in patients with severe rheumatoid     arthritis, in recipients of solid-organ transplants, healthy volunteers and experiments with     animals, and information from those other research studies suggest that this RAD001 may help     to stop cancer cells from growing abnormally.   "
199993|NCT00458250|"     Many patients suffering various malignant and non-malignant diseases need hematopoietic stem     cell transplantation from a healthy person. In the majority of cases there is no matched     related or unrelated donor.      Some researchers have been performed transplantation from semi-matched (haploidentical)     related donors with relatively good results.      Chinese researchers have been performed this kind of transplantation using CAMPATH-1H and     their reports indicates good results.      Chinese populations have more homogenous genetic background than Iranians. In this project,     we are going to study the feasibility of this method of haploidentical transplantation in     Iranian patients.   "
199994|NCT00458263|"     One arm, open, prospective, intervention study to assess biochemical markers of growth     response to Growth Hormone treatment in 20 Children, aged 3-9 years old, with idiopathic     short stature. All participants will be treated with Growth Hormone during the first year of     the study (and then in accordance with the local ethic requirement, to supply drug which is     not approved for the indication used in the study, for additional 3 years) and then will be     followed up for the next 3 years. The impact of Growth Hormone therapy on clinical laboratory     parameters that are indicative of the growth response will be assessed by collecting blood     and urine samples during the 4 years study period. The primary endpoints are measurements of     height and growth velocity during the year of Growth Hormone treatment, the height at the     beginning of puberty and final height. Secondary endpoints are psychological parameters,     assessed by questionnaires.   "
199995|NCT00458276|"     Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability     (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan     is an investigational intravenous drug that blocks the endothelin receptors. This clinical     trial will assess the potential benefit of tezosentan compared with placebo in the treatment     of patients undergoing open heart surgery with cardiopulmonary bypass (CPB). Treatment time     is from the start of surgery up to 24 hours.   "
199996|NCT00458289|"     Patients with end-stage renal disease (ESRD) commonly have high concentrations of     phosphorous, a mineral, in the blood (hyperphosphatemia). This is a result of their inability     to excrete phosphorous by the kidneys. This in turn may result in the development of a     condition known as secondary hyperparathyroidism and renal osteodystrophy or bone disease. As     such, these patients often receive medications known as phosphate binders such as calcium     carbonate or acetate, sevelamer, aluminum hydroxide and lanthanum carbonate to manage and     treat hyperphosphatemia.      Lanthanum carbonate is a newly available phosphate binding agent that is effective in the     management of hyperphosphatemia and preventing secondary hyperparathyroidism. It works in the     gastrointestinal tract by binding to the phosphorus in the diet. ESRD patients taking     lanthanum carbonate are counseled to chew the tablets completely before swallowing, with or     immediately after meals. However, patients who are intubated or receiving nutrition via     feeding tubes are unable to chew the tablets. For these patients, medications are commonly     crushed and administered via the tube. Moreover, some patients prefer to crush the tablets     and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum     carbonate tablets prior to administration and taking it with food would be as effective as     chewing them.      The purpose of this study is to compare the efficacy of phosphate binding between chewed and     crushed lanthanum carbonate tablets.   "
199997|NCT00458302|"     The purpose of the study is to compare the efficacy, safety and tolerability of     darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination     therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who     have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50     copies/ml for at least 24 weeks.   "
199998|NCT00458315|"     The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel,     Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.   "
199999|NCT00458328|"     Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group     study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by     ultrasound   "
200000|NCT00458341|"     In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation     (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator     (CFTR) protein. PTC124 has been shown to partially restore CFTR production in animals with CF     due to a nonsense mutation. The main purpose of this study is to understand whether PTC124     can safely increase functional CFTR protein in the cells of patients with CF due to a     nonsense mutation.   "
200001|NCT00458354|"     1. To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural          repair compared with standard of care methods (control) to obtain watertight dural          closure intraoperatively in patients undergoing spinal surgery.        2. To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural          repair compared with standard of care methods (control) to obtain watertight dural          closure in patients undergoing spinal surgery up to 90 days post-procedure.   "
200002|NCT00458367|"     The purpose of this research study is to gather information on the safety and efficacy of     risperidone when used in routine clinical practice.   "
200025|NCT00464451|"     The purpose of the study is:        1. To compare the efficacy of dexmedetomidine versus chloral hydrate as pediatric sedation          agents for EEG studies. Efficacy will be determined by successful EEG study completion          and by minimum degree of sedation induced patient agitation (SAS score).        2. To compare the safety and adverse event profile of dexmedetomidine versus chloral          hydrate during sedation of pediatric patients for EEG studies. Comparison will be based          on variance of vital signs (HR, MAP, RR, O2SAT, ETCO2) from baseline during sedation as          well as the frequency of adverse events during and following sedation.        3. To compare quality of EEG recording obtained with dexmedetomidine or chloral hydrate and          to those of non-sedated pediatric EEG studies. Quality will be determined by the degree          of background beta-wave activity.   "
200003|NCT00458380|"     On February 2004, a law (n. 40/2004) regulating assisted reproduction techniques (ARTs) was     approved in Italy. This law aimed to regulate the treatment of infertility in Italy, contains     several restrictions, such as the prohibition to fertilize more than three oocytes and the     obligation to transfer simultaneously all embryos obtained. Several evidences showed that the     outcome of the in-vitro fertilization (IVF) techniques is strongly correlated with quality of     transferred embryos (choosing the right embryos). Furthermore, this prerequisite is actually     illegal in Italy, and an optimal oocyte selection can be considered as the only one crucial     factor in the determining the outcome of the IVF cycle (choosing the right oocytes).     Experimental data have demonstrated that perifollicular blood flow assessment is a good     marker of oocyte competence, embryo viability, implantation potential, and subsequent     pregnancy rate.      The purpose of this study will be to evaluate in a clinical setting whether the assessment of     the perifollicular vascularity is a feasible and useful procedure for the selection of     oocytes with the best developmental potential in IVF programs when only a limited number of     oocytes can be fertilized.   "
200004|NCT00458393|"     The purpose of this study is to determine whether daily use of emtricitabine/tenofovir     disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV     counseling, condoms, and treatment for other sexually transmitted infections (STIs).   "
200005|NCT00458406|"     Context: The obstructive sleep apnea syndrome (OSAS), i.e., snoring with difficulty breathing     during sleep, is common in children. Continuous positive airway pressure (CPAP) therapy is     the usual treatment for children who do not improve following surgery. However, CPAP is     uncomfortable and is often not tolerated. We therefore plan to study a modification of     bilevel positive airway pressure therapy, BiPAP with Bi-Flex that may be more comfortable.      Objectives: The primary objective of this study is to determine whether BiPAP with Bi-Flex     results in improvement in adherence as compared to CPAP. The secondary objective is to     determine whether Bi-Flex has similar therapeutic efficacy compared to CPAP, as determined by     sleep study. Additional objectives include comparing CPAP and Bi-Flex effects on comfort and     determining which parameters predict adherence.      Study Design/Setting/Participants: A single center, randomized controlled double-blind study     of Bi-Flex vs CPAP use in children with OSAS over a 3 month period.      Intervention: Bi-Flex vs CPAP Study Measures: Objective compliance recordings, sleep study     results, subjective questionnaire results. .   "
200006|NCT00458419|"     Endorphins are naturally occurring narcotic substances that are released when individuals     perform exercise. The hypothesis of the study is that endorphins reduce the severity of     breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD).     The initial five visits include familiarization and validation of a computerized system for     patients to report dyspnea and leg discomfort continuously during exercise testing.      At Visits 6 and 7 blood is drawn to measure serum endorphin levels pre-exercise, end     exercise, and 30 minutes after exercise. Normal saline or naloxone is given intravenously 5     minutes prior to exercise in a double-blinded design. The primary outcome is the slope of     oxygen consumption - dyspnea.   "
200007|NCT00458432|"     This study uses magnetic resonance imaging (MRI) to explore the areas of the brain involved     in different types of mental processes, in particular, the brain regions involved in     perception, recognition, learning, and memory. MRI uses a magnetic field and radio waves to     produce images of body tissues and organs. In this study it is also used to measure blood     flow in different regions of the brain while the subject is presented auditory or visual     stimuli. The subject lies on a table that can slide in and out of the scanner (a narrow     cylinder), wearing earplugs to muffle loud noises that occur during the scanning process.     Subjects are in the scanner no more than 2 hours.      Healthy, right-handed normal volunteers between 20 and 40 years of age who have at least a     high school education may be eligible for this study.      While undergoing MRI, participants are presented visual stimuli (pictures or geometric shapes     on a projection screen) or auditory stimuli (tones played through a set of headphones).     Unpleasant stimuli such as loud noise, electric shocks, heat, or tactile stimuli are     administered occasionally. The intensity of these stimuli is similar to those experienced in     practice sessions before the scanning. Participants receive between 30 and 60 visual or     auditory stimuli during the scanning session, and each stimulus lasts about 1 second. In some     studies participants are asked to move a joystick that controls a rating bar presented on a     projection screen to indicate when they expect to receive these stimuli and how sure they are     that they will occur. Heart rate, respiration rate, and sweat gland activity are monitored     during the MRI sessions, using electrodes placed on the fingers to measure heart rate and     sweat gland activity and a sensor strapped around the chest to measure respiration. Subjects     are in the scanner no more than 2 hours.      Following the experiment, subjects may be asked questions about their experiences during the     study.   "
200008|NCT00458445|"     The purpose of this study is to determine whether SPD465 is safe and effective in the     treatment of ADHD in young adult drivers after a duration of 16 hours.   "
200009|NCT00458458|"     (A) Major 1) to compare the effectiveness of norethindrone acetate (NA) with GnRH agonist     (Lupron-Depot-3) in relieving symptoms of endometriosis, 2) to compare bone density in the     two treated groups in order to demonstrate that NA does not affect bone density; (B) Minor:     1) To compare the lipid profiles of patients in the two groups to confirm the hypothesis that     the effects of NA and GnRH agonists on lipid profiles are similar, 2) To determine whether     quality of life, assessed by questionnaire, is better in patients assigned to NA than in     patients assigned to GnRH, 3) To determine whether NA has fewer adverse effects than GnRH     agonist.   "
200023|NCT00464425|"     Postoperative ileus remains a significant medical problem after colorectal surgery that     adversely influences patients' recovery and prolongs hospital stay. In fact, a substantial     portion of the overall hospitalisation period after colorectal surgery is attributed to the     time it takes for ileus to resolve. Although laparoscopic colorectal surgery has been proven     to be associated with better short-term clinical outcomes including faster return of     gastrointestinal function than open surgery, the duration of postoperative ileus in the     laparoscopic arm is still reported to be as long as 4 days in most of the randomised trials.     Additional measures are thus necessary to further enhance the gastrointestinal recovery after     laparoscopic colorectal surgery in order to maximise its benefits, and acupuncture may be one     of the options. Acupuncture is widely accepted in China as well as throughout the world as an     effective treatment option for the management of postoperative nausea and vomiting and     various functional gastrointestinal disorders. Its role in treating postoperative ileus,     however, is less clear, and data from the Chinese as well as the Western literature are     scarce. We therefore propose to carry out a prospective randomised sham-controlled pilot     study to assess the efficacy of electroacupuncture in treating postoperative ileus after     laparoscopic colorectal surgery. The acupoints relevant to the treatment of abdominal     distension and constipation, including Zusanli (stomach meridian ST-36), Sanyinjiao (spleen     meridian SP-6), Hegu (large intestine meridian LI-4), and Zhigou (triple energizer meridian     TE-6) will be used.   "
200010|NCT00458471|"     The overall goal of this project is to develop a new approach for the prevention of urinary     tract infection (UTI) in persons who rely on indwelling catheters for bladder drainage.     Veterans with spinal cord injury (SCI) frequently require chronic bladder catheterization.     Most individuals with SCI have neurogenic bladders, and the resulting urinary stasis and     bladder catheterization predispose them to recurrent UTI.1 The presence of a urinary catheter     dramatically increases the risk of UTI, not only through contamination of the urinary tract     during catheter changes, but also by the presence of a foreign body in the urethra and     bladder. Implanted urinary catheters rapidly acquire a complex, three-dimensional biofilm     composed of bacteria, their extracellular products, and components deposited from bodily     fluids. The pathogenic organisms in a biofilm continually seed the bladder, leading to     bacteriuria and/or UTI.2 Bacterial interference, or using benign bacteria to prevent     infection with virulent pathogens,3, 4 may offer a solution to the significant problem of     recurrent episodes of UTI in persons with indwelling catheters. Since biofilm formation on a     wet implanted device such as a urinary catheter is nearly impossible to prevent,5, 6 we     propose instead to manipulate the adherent microbial flora. We propose that inserting urinary     catheters than have been pre-inoculated with a benign strain of Escherichia coli (83972) will     be an efficient means to colonize the neurogenic bladder with this harmless organism. If     successful colonization is achieved in this pilot trial, a larger clinical trial will be     designed to test the efficacy of this approach to prevent bladder colonization by pathogenic     organisms and thus to prevent UTI.   "
200011|NCT00458484|"     RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal     tissue.      PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic     radiosurgery and to see how well it works in treating patients with kidney tumors who are     poor candidates for surgery.   "
200012|NCT00458497|"     This study is designed to assess the effects of socks and bedding materials on foot pain, the     level of blood oxygen existing in the feet and quality of sleep in subjects who have chronic     foot pain from either diabetic neuropathy or other conditions, e.g., peripheral arterial     disease, regenerative joint disease). The three main hypotheses to be tested are: 1)compared     to placebo socks, subjects wearing Holofiber socks experience reduction in foot pain,     2)compared to placebo bedding, subjects sleeping in beds lined with a Holofiber mattress pad     experience improved quality of sleep and 3) compared to placebo socks, subjects who wear     Holofiber socks will have increased blood oxygenation levels in their feet.   "
200013|NCT00458510|"     Cancer patients taking regular medication for their pain often still have episodes of severe     pain that 'break through' despite their background pain treatment. Fentanyl is a strong,     short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains     fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal     spray. This study will examine the long-term safety of Nasalfent in the treatment of     breakthrough cancer pain.   "
200014|NCT00458523|"     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them.      PURPOSE: This phase II trial is studying the side effects and how well alemtuzumab works in     treating patients with B-cell chronic lymphocytic leukemia in partial remission or complete     remission.   "
200015|NCT00458536|"     The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study     vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony     Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any     side effects associated with this study vaccine. GM-CSF is similar to a substance in the body     that stimulates the production of white blood cells. To create the study vaccine, cells will     be removed from the participants tumor and fused with dendritic cells which are obtained from     the participants blood. Dendritic cells are responsible for immune responses to foreign     substances that enter the body. Animal studies have shown that these fused cells can     stimulate powerful anti-tumor responses.   "
200016|NCT00458549|"     RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One     type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect     the growth of prostate cancer.      PURPOSE: This randomized clinical trial is studying polyunsaturated fatty acids in treating     patients with prostate cancer undergoing prostate biopsy and/or surgery.   "
200017|NCT00458562|"     RATIONALE: Finding certain changes in genes may help doctors predict which patients are at     risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may     help the study of cancer in the future.      PURPOSE: This clinical trial is studying genes that may predict which patients are at risk of     developing cervical intraepithelial neoplasia or invasive cervical cancer.   "
200018|NCT00458575|"     The main purpose of this study is to evaluate the preliminary safety and immunogenicity     (ability of an antigen to provoke immune response in the human body) of CNTO 2476,     administered subretinally, in participants with advanced retinitis pigmentosa (RP; disease of     the eye that leads to loss of vision and blindness) with either light perception only (LP) or     hand motion (HM).   "
200019|NCT00464373|"     The aim of this randomized placebo-controlled study is to demonstrate the efficiency and     safety of the injection of Botulinum Toxin Type A (200 Units) into the external urethral     sphincter for the treatment of chronic prostatitis/chronic pelvic pain.   "
200020|NCT00464386|"     The purpose of this study is to prospectively evaluate whether the addition of continuous     glucose monitoring to point-of-care (POC) glucometer monitoring improves glucose control.   "
200021|NCT00464399|"     To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in     de novo renal transplant recipients by assessing rejection rate everolimus trough levels,     other safety laboratory variables and adverse events.   "
200022|NCT00464412|"     The purpose of the study is to determine the effect of a short educational program on young     women's knowledge and beliefs about osteoporosis. They hypothesis is that following the     intervention women who receive the educational program will have greater knowledge and     beliefs about osteoporosis.   "
200024|NCT00464438|"     This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic     solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of     age   "
200026|NCT00464464|"     The purpose of this study is to evaluate the efficacy of a cognitive-behavioral treatment,     that includes a caregiver-focused social support intervention, for depression in persons with     Parkinson's disease.      Individuals who are unable to travel to the study site, but are interested in participating     and meet all other eligibility requirements, will be allowed to participate over the phone.   "
200027|NCT00464477|"     The Division of Medical Genetics at the University of Mississippi Medical Center is     recruiting parents of children with a pervasive developmental disorder (including autism,     autistic spectrum disorder, PDD-NOS, Asperger syndrome, childhood disintegrative disorder,     and Rett syndrome) to participate in a study to help determine potential causes of the     increasing prevalence of these disorders. The study is being conducted using an anonymous     on-line survey available to parents through a secure link.      The study consists of approximately 90 questions about the affected child, siblings, parents,     and grandparents, which will take roughly 10-15 minutes to complete. Several families will     also be invited to participate in a phone interview. Both the survey and the phone interview     are conducted using a self-designated code to protect anonymity and patient privacy. No     identifying information such as name, date of birth, address, or phone number will be asked.     Only questions regarding the year of birth of family members will be asked.   "
200028|NCT00464490|"     Mechanical ventilation commonly is associated with patient agitation requiring sedation to     alleviate discomfort and reduce excessive central respiratory drive. Upon recovery from acute     respiratory failure, sedation is reduced to facilitate the withdrawal of ventilatory support.     In some patients, abrupt reduction in sedation provokes severe agitation that causes     catecholamine release resulting in severe hypertension, tachycardia and tachypnea. This     requires increased sedation to bring hemodynamic and respiratory function under control.      Dexmedetomidine is an alpha-2 receptor agonist with both sedative and analgesic properties     that allows for the reduction in the anesthetic and analgesic requirements in the     perioperative setting. In addition to its sedative effects, alpha-2 receptor stimulation in     the central nervous system inhibits sympathetic activity and reduces plasma epinephrine and     norepinephrine levels, thereby lowering both arterial blood pressure and heart rate. Because     alpha-2 receptor stimulation does not cause respiratory depression, dexmedetomidine may     facilitate the transition to unassisted breathing in profoundly agitated patients. The     investigators will prospectively evaluate dexmedetomidine in 30 patients who could not be     extubated because of agitation with hemodynamic instability and tachypnea.      The purpose of this study is to test if a larger prospective randomized controlled pilot     study can show that dexmedetomidine facilitates weaning and extubation in patients who have     failed previous attempts because of agitation and hyperdynamic cardiopulmonary response.   "
200029|NCT00464503|"     This study aims to investigate whether statines (rosuva- and pravastatin) induce tubular     proteinuria.   "
200030|NCT00464516|"     The study is designed as a single-center, randomized, double-blind, placebo-controlled study     in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will     either receive estetrol or placebo during a 2 week treatment period.      Several biological markers, such as a cellular growth marker and cell death markers, will be     assessed in the tumor tissue and surrounding normal tissue before and after the treatment     period. During the 2 week interval between diagnosis of breast cancer and surgical resection,     no therapy for breast cancer is usually administered.   "
200031|NCT00464529|"     The purpose of this study is to determine the safety and accuracy of the Real-Time Continuous     Glucose monitoring System (RT-CGMS)in measuring glucose in patients scheduled for surgery;     before, during and after surgery.   "
200032|NCT00464542|"     This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of     HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.   "
200033|NCT00464555|"     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells     are destroyed, resulting in poor blood sugar control. The purpose of this study is to     determine the safety and effectiveness of islet transplantation, combined with     immunosuppressive medications and medications to support islet survival, for treating type 1     diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic     episodes.   "
200034|NCT00464568|"     This current study is planned as a dedicated pharmacodynamic (effect of drug on the body)     study to investigate the dose response in rhinitic subjects at doses where GSK256066 has been     proven to work (200mcg) or expected to (50mcg) work. This study also aims to investigate the     lower end of the predicted therapeutic range.   "
200035|NCT00464581|"     Cystoid macular edema (CME) is the most common cause of suboptimal post-operative visual     acuity in uncomplicated cataract extractions. Over two million cataract extractions are     performed each year, with a reported incidence ranging from 1.5 to 6.9%, resulting in an     estimated 20,000-130,000 new cases of CME annually. Clinical CME historically was associated     with visual acuity of 20/40 or worse with fluorescein angiographic evidence of macular edema     in a classic petaloid pattern. Angiographic CME physiologically signals an inflammatory     process causing distortion of the outer plexiform layer, which if not resolved quickly could     result in non-repairable visual loss. Topical, periocular, or intravitreal corticosteroids,     despite their associated side effects, are the mainstay for pharmacologic treatment for     patients with CME. Their efficacy has never been demonstrated in a randomized, controlled and     blinded study.      This is an open-label, Phase II study of intravitreally administered ranibizumab in subjects     with cystoid macular edema secondary to non-ischemic retinopathy, as seen following cataract     surgery with intraocular lens implantation.   "
200036|NCT00464594|"     The purpose of this study is to compare the suppressive effect of two kinds of interventions     on the worsening/progression to definite diabetes: standard lifestyle guidance and standard     lifestyle guidance combined with pharmacological intervention (monotherapy with one of     acarbose, metformin, or gliclazide).   "
200037|NCT00464607|"     Purpose of the study is the evaluation of the tolerability (both local and systemic) and the     clinical efficacy (in terms oocytes recovered) of subcutaneously versus intramuscularly     administered Merional® (IBSA, Lugano – CH) in patients undergoing controlled ovarian     hyperstimulation (COH) in an ART programme (IVF).   "
200038|NCT00464620|"     This study will examine the response rate and the 6-month progression-free survival rates of     subjects with advanced sarcoma treated with dasatinib.   "
200039|NCT00464633|"     Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic     leukemia patients.      Primary objective is to determine overall response rate.      The secondary objectives are:        -  to assess overall safety,        -  to assess duration of response, progression free survival, and overall survival.      Clinical benefit and pharmacokinetics parameters are also evaluated.   "
200040|NCT00464646|"     The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab     to treat HER2-positive breast cancer will affect heart function. This study will evaluate:        -  How bevacizumab, given with chemotherapy, and then bevacizumab given with trastuzumab          after surgery, will affect breast tumors        -  Side effects from adding bevacizumab to chemotherapy and trastuzumab        -  Whether adding bevacizumab to chemotherapy and trastuzumab for breast cancer will affect          the heart        -  If receiving bevacizumab will have any effect on how patients recover from surgery   "
200041|NCT00464659|"     The main objective of this study is to evaluate the evolution of memory deficit (verbal     episodic memory, procedural memory, working memory, short-term memory) in Sleep Apnea     Obstructive Syndrome (SAOS) patients after treatment by Continuous Positive Airway Pressure     treatment (CPAP). For thus, we will compare memory tests in two separate groups of SAOS     patients with effective  versus ineffective ( or sham) CPAP, before and 6 weeks after the     beginning of the treatment. Thus we will assess the evolution of memory deficit, the     effectiveness of the treatment on the evolution of memory deficit before and 6 weeks after     the beginning of the treatment by effective  versus ineffective CPAP.      We feel the results of the tests of memory will show greater memory disorders in patients     with SAOS before beginning the treatment rather than six weeks afterwards. Thus we     hypothesise that, after the treatment by effective CPAP, the patients with SAOS will have     greater improvement of their memory disorders than those treated by sham CPAP.   "
200042|NCT00464672|"     This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the     2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in     the EU and many other worldwide countries, according to the US FDA Draft Guidance for     Industry Clinical data needed to support the licensure of trivalent inactivated influenza     vaccine, issued in March 2006, and to evaluate safety, clinical tolerability and     immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional     influenza vaccine already licensed in US. The purpose of the control arm is primarily to     provide a comparative assessment for safety, not immunogenicity or effectiveness.   "
200043|NCT00464685|"     This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone     with laser treatment vs. laser treatment alone in patients with diabetic macular edema.   "
200044|NCT00464698|"     The purpose of this study is to assess the efficacy of Duloxetine in the treatment of     obsessive compulsive disorder.   "
200045|NCT00468845|"     To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy ,     measured using subject reported assessments of pain.   "
200046|NCT00468858|"     The purpose of this study is to evaluate the safety and effectiveness of two different     formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two     doses are given six months apart to adults and children.   "
200047|NCT00468871|"     This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and     efficacy study. The aim of this study is to evaluate the effect of an intravitreal     fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with     unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.   "
200048|NCT00468884|"     Context: Oral formulations of GLP-1 and PYY3-36, two satiety peptides, were studied. An oral     delivery system would be preferable in many of the possible therapeutic indications of these     peptides.      Objectives: Our objective was to establish the pharmacological profile of increasing oral     doses of GLP-1 and PYY3-36 in healthy volunteers. In addition, the pharmacological effects of     GLP-1 were investigated.      Setting: Single center escalating dose study with oral applications. Subjects and Methods: In     the first part, GLP-1 was given orally to 6 male subjects; the treatment consisted of one of     the following oral doses of either GLP-1 (0.5, 1.0, 2.0 and 4.0 mg) or placebo. In the second     part, PYY3-36 was given orally to another 6 healthy male subjects; the treatment consisted of     one of the following oral doses of either PYY3-36 (0.25, 0.5, 1.0, 2.0 and 4.0 mg) or     placebo.   "
200049|NCT00468897|"     The present pharmacokinetic study is designed to compare bioavailability and assess     bioequivalence of two Rosiglitazone XR formulations produced at two different sites.Both     formulations will be tested in fasting healthy volunteers   "
200050|NCT00468910|"     This randomized phase II trial is studying how well aspirin works in preventing colorectal     cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of     certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.   "
200051|NCT00468923|"     Heart disease and stroke are major causes of death and disability worldwide and are largely     preventable. Cholesterol and blood pressure are major cardiovascular risk factors. Previous     studies have shown that certain drugs can effectively and safely lower cholesterol and blood     pressure and prevent heart attacks and strokes. Such studies have been conducted primarily in     people who had already sustained a heart attack or a stroke, or in people with high     cholesterol and blood pressure levels. However, most heart attacks and strokes occur in     people with average (normal) cholesterol and blood pressure. Therefore, in the HOPE-3 trial     the investigators will evaluate whether a cholesterol lowering drug, rosuvastatin, and a     combination blood pressure lowering pill, candesartan/hydrochlorothiazide, used alone or     together can reduce the risk of heart attacks, stroke and their sequelae in people without     known heart disease and at average risk.   "
200052|NCT00468936|"     Stable heart transplant patients on Mycophenolate Mofetil (MMF) will sign a screening consent     form in order to be evaluated with the gastrointestinal symptom rating scale (GSRS)     questionnaire. Those who score three or more on at least two questions are eligible for the     study. Once they sign a study consent they are randomized to one of two arms. It is thought     that the severity of GI side effects will be reduced over time in patients who are in the     Myfortic arm versus the severity of GI side effects over time in patients who remain on MMF     treatment. Patients are evaluated by GSRS, The Psychological Well-Being Schedule, and the     IT01/02 Checklist for the evaluation of GI symptoms and followed for one year (visits 1     month, 3 months, 6 months, 12 months).   "
200053|NCT00468949|"     Main Research Questions:      We want to measure the change in quality of life in Dupuytren's disease patients who do and     do not undergo surgery. Also, we want to test the validity of health related quality of life     measurements in patients with Dupuytren's disease.      Why is this research important? Some patients with Dupuytren's contracture require excision     surgery or palmar fasciectomy. Other patient's with Dupuytren's contracture do not require     surgery; however, these patients may need surgery in the future. No studies have reported the     health-related quality of life of patients with Dupuytren's disease whether related to     surgical intervention or not.      What is being studied? We are studying the difference and change in health-related quality of     life in patients suffering from Dupuytren's disease who require excision surgery and do not     require surgery.   "
200054|NCT00468962|"     Functional properties of chitooligosaccharides have been studied for antitumor activity,     immunostimulating effects, antimicrobial activity, free radical scavening activity, adn     angiotensin I converting enzyme inhibitory activity. Recent in vitro, and in vivo toxicity     and absorbability studies have demonstrated that chitooligosaccharides have high     absorbability and are essentially non-toxic. In the present study, we prepared a     chitooligosaccharide with high absorbability and evaluated its effects on activation of     immune function and cardiovascular funciton(lipid, atrial stiffness, etc) in healthy adults.      This study was a 8-week, randomized, double-blind clinical trial. The 30 volunteers were     divided into a control group(n=10), half dose chitooligosaccaride(FACOSTM) intake     group(n=10), and full dose FACOS intake group(n=10). Peripheral blood mononuclear     cells(PBMCs) were isolated and cultured in 12 well plate for 48 hours. Cytokine production by     PBMCs pre- and postintervention were measured simultaneously after stimulation with     lipopolysaccaride.   "
200055|NCT00468975|"     A study to determine the ability of different doses of PF-610,355 to open the airways in     asthmatic patients by comparison with placebo and a marketed drug that also opens the airways     in asthmatic patients.   "
200056|NCT00468988|"     Compare the effect of Xalatan with benzalkonium chloride on the ocular surface to those     effects observed with Travatan Z without benzalkonium chloride after a single dose   "
200057|NCT00469001|"     To use continuous measurement of NT Pro BNP level as guide in therapy patients with CHF.   "
200058|NCT00469014|"     The goal of this clinical research study is to find the best dose of clofarabine and     fludarabine that can be given with busulfan followed by an allogeneic blood stem cell     transplant. Researchers will study whether this combination can help to control the disease,     and look at the safety of this combination. Researchers also want to find out if combining     busulfan with clofarabine alone or combining busulfan with both fludarabine and clofarabine     will improve the treatment, compared with the previous standard method using busulfan and     fludarabine alone.   "
200059|NCT00469027|"     The primary objective is to establish the safety of autologous progenitor cell-based gene     therapy of heNOS in patients with severe Pulmonary Arterial Hypertension(PAH) refractory to     conventional treatment.   "
200060|NCT00469040|"     GW642444 (the study medicine) is a new experimental medicine for treating asthma and chronic     obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness     because the small tubes (bronchioles) that carry air in and out of the lungs become narrow.     We hope that the study medicine will work by relaxing the muscles in the airways and help to     keep the airways open, and make breathing easier. The study medicine might improve on     available treatments by having fewer side-effects, and by working faster and for longer, so     that patients could take it once daily, instead of twice daily.      When a medicine is made into a form ready to be given to patients, inactive ingredients are     often added. Inactive ingredients might be used to help a medicine work better, to make it     easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In     this study, the study medicine contains the inactive ingredient magnesium stearate.      We need to check that the study medicine doesn't cause problems when inhaled along with     magnesium stearate. So, we're doing this study in healthy people to find out the answers to     these questions.      1)Do repeated once-daily doses of the study medicine cause any important side effects when     inhaled, along with magnesium stearate, as a fine powder? 2)How much of the study medicine     gets into the bloodstream and how long does the body take to get rid of it?   "
200061|NCT00469053|"     The purpose of this study is to determine whether two different analgesic transdermal patch     formulations lead to same plasma levels of active ingredient after multiple dose application.   "
200062|NCT00469066|"     To study changes in tumor and normal organ size and/or position which occur during a course     of radiation treatments.   "
200063|NCT00469079|"     The use of smokeless tobacco (ST) as a substitute for cigarette smoking has been suggested     since it is considered by some to be a less harmful tobacco product (Russell, Jarvis and     Feyerabend, 1980; Russell et al, 1981; Rodu, 1994). ST does not have the volatile     constituents and carbon monoxide (CO) that are found in cigarette smoke. Since ST is not     smoked there would be less risk of cardiovascular and lung disease. In addition the harm     associated with second hand smoke would be eliminated. Although the health risks are reduced     in ST users, they still exist due to the presence of nitrosamines found in ST. A better     approach would be to use nicotine replacement that did not contain carcinogens, however the     cost of such NRT could be prohibitive especially in third world countries where the rate of     smoking is continuing to rise and the per capita income is much lower than in the United     States.      Purpose: The goal of this study is to evaluate the health effects of Camel Snus, the new oral     tobacco product produced by RJ Reynolds and Taboka, produced by Phillip Morris. These     products are pasteurized rather than fermented and contain less moisture to eliminate     spitting. They are marketed as an alternative to cigarette smoking.   "
200064|NCT00469092|"     This trial is conducted in Africa, Asia, Europe, Oceania and South America.      This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin     glargine once daily all in combination with metformin and glimepiride in insulin naive     subjects with type 2 diabetes.   "
200065|NCT00469105|"     The aim of this research will be to perform a small randomized controlled trial (RCT) of a     new diabetes educational intervention that teaches self-management skills that compensate for     poor numeracy skills among a sample of primary care patients with type 2 diabetes and low     literacy and/or numeracy.   "
200066|NCT00469118|"     This study will document efficacy and safety of the Axiom Worldwide DRX9000™ for treatment of     low back pain (LBP) in a prospective, randomized, crossover, multicenter trial utilizing a     standardized clinical research multimodal protocol. During the first two weeks subjects are     randomized to receive either conservative care or DRX treatment first and then cross over to     receive either conservative care or DRX treatment the next 6 weeks. This study will test the     hypothesis that standardized 6-week treatment regimen of spinal decompression using DRX9000™     will reduce chronic lower back pain more than conservative therapy (current baseline     therapy).   "
200067|NCT00469131|"     The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that     of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver     transplantation.   "
200068|NCT00469144|"     The goal of this clinical research study is to learn if giving busulfan in a dose based on     blood levels, along with a fixed (unchanging) dose of fludarabine, is more effective and     causes fewer side effects for AML or myelodysplastic syndrome patients than the standard     method of giving a fixed busulfan dose based on body size, along with a fixed dose of     fludarabine. The safety of dosing based on blood levels will also be studied.   "
200069|NCT00469157|"     To assess the compatibility of Optive with refractive surgery (PRK and LASIK)     post-operatively.   "
200070|NCT00469170|"     The proposed study is a multi-centre, open-label crossover study to assess the safety and     acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a     12 week period in 200 healthy, sexually active women.   "
200071|NCT00469183|"     Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through     biopsy examination.   "
200072|NCT00469196|"     Mesothelioma is an incurable cancer involving the lining of the lung. Patients usually suffer     progressive symptoms of shortness of breath and chest pain, until they ultimately succumb to     the disease. While a very small number of patients qualify for aggressive treatment with     surgery, chemotherapy and radiation, and enjoy long-term survival, the vast majority of     patients have incurable disease. The treatment options currently available, including     chemotherapy and radiation treatment, are only modestly effective at alleviating symptoms and     improving life expectancy. This trial explores the use of new radiation technology     (tomotherapy), to treat mesothelioma more aggressively than has been possible before.     Tomotherapy's ability to treat unusual shaped tumours, particularly when they are wrapped     around sensitive normal tissues (the lung), enable higher doses of radiation to be used and     this may improve its effectiveness. We will treat 17 patients with tomotherapy and assess the     breathing, symptoms, and quality of life of the patients before and after treatment   "
200073|NCT00469209|"     Primary Objectives:        1. To evaluate the toxicity and safety of a combination of bortezomib with arsenic          trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma        2. To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic          acid and high-dose melphalan in patients with multiple myeloma        3. To determine the effects of bortezomib on melphalan pharmacokinetics   "
200074|NCT00469222|"     Current treatments for limited stage small cell lung cancer have poor cure rates. The     addition of chest radiation to chemotherapy improves cure rates, but these cancers still come     back in the chest 30-50% of the time. Two factors which can improve control and cure rates     for this cancer are increasing the chest radiation dose and minimizing the overall time it     takes to complete radiation treatments. One method to achieve both of these goals is to give     more radiation each day. This study is meant to study how tolerable and effective it would be     to increase the intensity of chest radiation for small cell lung cancer patients by     increasing the daily radiation dose. We aim to find the highest dose of chest radiotherapy     that can be safely given with chemotherapy using this strategy. Patients in this trial will     be monitored before, during and after their radiation and chemotherapy treatments for     treatment side-effects, how effective treatments are at controlling their cancer and quality     of life changes. Results from this trial will help to define more effective radiotherapy     doses which are tolerable for this type of lung cancer and the quality of life changes     patients experience when they undergo these treatments.   "
200075|NCT00469235|"     This trial will assess the safety and efficacy of 50 and 200ng Juvista per linear cm of wound     margin administered by intradermal injection following the excision of keloid scars on the     ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly     distressing for patients as they are very difficult to conceal and are usually bilateral. As     the recurrence rate and growth rate of keloids can vary significantly between individuals,     trial subjects will have bilateral ear lobe keloids and will act as their own control. One     ear lobe will be treated with Juvista following keloid excision and one with placebo.   "
200076|NCT00469248|"     The role of intra aortic balloon counterpulsation in patients experiencing acute myocardial     infarction with shock is not established. We hypothesised that use of such a device would     lead to improved outcomes in these patients.   "
200077|NCT00469261|"     The aim of the study is to assess the efficacy of an antibiotic treatment with tetracycline     (doxycycline) in the early stage of large reperfused acute myocardial infarction (AMI), in     preventing left ventricular (LV) remodeling.   "
200078|NCT00469274|"     The purpose of this study is to compare the effectiveness of two strategies of post-exposure     prophylaxis (PEP) in healthcare workers (HCWs) who have been vaccinated with acellular     pertussis vaccine and have been exposed to pertussis Secondary Objectives include a     comparison of the costs of each PEP strategy and an assessment for risk factors associated     with healthcare-associated acquisition of pertussis.   "
200094|NCT00469482|"     A combined strategy of Richmond Agitation and Sedation Scale (RASS) clinical targeting plus     bispectral index (BIS) guided sedation in mechanically ventilated, critically ill patients     will decrease time on mechanical ventilation, decrease the duration of intensive care unit     (ICU) delirium and coma, and will improve subacute neurocognitive function when compared to     sedation guided by RASS targeting alone.   "
200095|NCT00469495|"     The purpose of this project is to investigate the efficacy of early, empiric anti-helminthic     therapy combined with standard pentavalent antimony in the treatment of subjects co-infected     with helminths and cutaneous leishmaniasis caused by L. brasiliensis. The study hypothesis is     that early intervention with antihelminthic therapy will improve response rates to antimony     in subjects with cutaneous leishmaniasis.   "
200079|NCT00469287|"     Rationale: The global prevalence of diabetes, along with its devastating effects on life     expectancy and quality of life, continues to increase. Worldwide, the total number of people     with diabetes is projected to rise from about 171 million in 2000 to 336 million in the year     2030. Type 2 diabetes accounts for about 85 percent to 95 percent of all diagnosed cases of     diabetes and is associated with a number of serious long-term complications, which are a     major cause of morbidity, hospitalization and mortality in diabetic patients. More evidence     is becoming available that both lifestyle and clinical intervention in the pre-diabetic     condition are effective in slowing down progression of pre-diabetes to overt diabetes.      Over many centuries, several forms of traditional medicine have developed which are often     based on fundamental principles that differ from those of Western medicine. One of the most     prominent characteristics of Traditional Chinese Medicine (TCM), is a more holistic approach     to the functioning and disfunctioning of living organisms. Every healthy organism is in a Yin     Yang balance and is considered to be a complex interplay between body and mind. Western     medicine relies on detailed classification of diseases, empirical investigations and     treatments targeting those disorders. However, Western medicine is showing an increased     interest in traditional forms of medicine.      Objectives: The primary objective of the present study is to determine consistency in     classification of DM type 2 in three categories as defined by Traditional Chinese Medicine     (TCM) in pre-diabetic subjects.      Secondary objectives are to find relationships between diagnosis according to TCM and risk     profile according to Western approach (fasting glucose and HbA1c in plasma, age, BMI, waist     circumference). Another objective is to find relationships between classification of risk for     DM type 2 according to TCM and objective parameters.   "
200080|NCT00469300|"     Currently approved drugs for the treatment of herpes labialis (cold sores) exhibit low levels     of efficacy due to the limited ability of the drugs to penetrate the skin to the sites where     the herpes virus is replicating. Iontophoresis uses electric current to enhance delivery of     drugs through the skin. This trial is testing a new iontophoretic device with a new acyclovir     gel to treat cold sores.   "
200081|NCT00469313|"     Hypothesis:benefits of inspiratory muscle strenght training with Respifit S decreases     symptoms, disability or handicap of patients affected by COPD. The inspiratory fraction     (inspiratory capacity IC/ total lung capacity TLC)may be functionally more representative     than other traditional indices.   "
200082|NCT00469326|"     This study investigates potential protective effect of atorvastatin pre-treatment in patient     with stable coronary artery disease undergoing percutaneous coronary intervention (PCI).     Patient are randomized to two groups: atorvastatin pre-treatment group (80mg atorvastatin two     days before PCI) and control group (PCI without atorvastatin pretreatment). Endpoint is     myocardial infarction measured by troponin I and creatine kinase myocardial band.   "
200083|NCT00469339|"     This study will examine what methods work best for encouraging Mexican-American family     members to talk about their risk for diabetes, heart disease, breast cancer and colon cancer.     Within the Mexican-American community, the family culture provides an important setting in     which individuals interpret and share their health information and formulate strategies to     engage in health-promoting behaviors. The information from the study will be used to design     risk communication approaches for Mexican-American households.      Members of households with at least three adults 18 to 70 years of age who are part of the     existing Mexican-American households recruited by the University of Texas M.D. Anderson     Cancer Center may be eligible for this study.      Participants are interviewed about their medical history, family history of disease, health     behaviors, beliefs about disease and disease risk, experiences living in the United States,     and relationships with family members and close friends. They are then provided information     about their family risk for diabetes, heart disease, breast cancer and colon cancer, based on     the information they provided in the interview. Two additional interviews are conducted over     the telephone that include questions about how the participants communicate with family     members about their risk and health behaviors.   "
200084|NCT00469352|"     The purpose of this study is to understand whether genes or certain factors in the     environment determine how eyes will respond to Lucentis (ranibizumab) treatment. For example,     whether having variants within specific genes means that a patient is likely to get better     vision from treatment than another patient with different genes.   "
200085|NCT00469365|"     Compare the effectiveness of 3 strategies by pharmacists to decrease the time to refill of     prescriptions for common chronic diseases (diabetes, hypertension, hyperlipidemia, heart     failure, depression, psychoses).   "
200086|NCT00469378|"     This is a study to count the number of white blood cells in the cerebrospinal fluid and blood     at the beginning and end of treatment with firategrast and at 4 and 12 weeks after stopping     firategrast. Cerebrospinal fluid flows through and protects the brain and spinal cord. It is     important to understand what happens to the number of white blood cells because they are     important in preventing infections.   "
200087|NCT00469391|"     The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients     who require weight loss prior to their Bariatric surgery.   "
200088|NCT00469404|"     The purpose of this study is to determine whether the plasma levels of two different     analgesic transdermal patch formulations lead to same plasma levels of the active ingredient     after single dose application.   "
200089|NCT00469417|"     The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with     methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of patients with primary     superficial basal cell carcinoma.      Secondary objectives are to compare cosmetic outcome and tolerability (adverse events) in     these patients, 3 months after treatment. In addition the recurrence rates in the two     treatment groups will be compared up to five years after treatment.   "
200090|NCT00469430|"     The purpose of this study is to determine if antibiotic treatment of appendicitis is an     option compared to surgery. The investigators' hypothesis is that a majority of patients with     appendicitis can heal without surgery and that there are several advantages with antibiotic     treatment related to time to recover, complications and economical aspects.   "
200091|NCT00469443|"     This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with     the addition of Avastin as 1st line treatment of colorectal cancer.   "
200092|NCT00469456|"     The objective of this study is to evaluate the effect of memantine versus placebo on     functional communication in patients with Alzheimer's Disease   "
200093|NCT00469469|"     This is a Phase II study of intravenous Bevacizumab in patients with pathologically confirmed     nonresectable primary adrenocortical cancer (ACC). Patients must have received no prior     therapy. They will receive Bevacizumab as a single agent every 2 weeks intravenously until     disease progression. This study will be open at multiple sites.   "
200096|NCT00469508|"     Modafinil is a non-amphetamine type stimulant that acts as a wakefulness-promoting drug, and     is approved for managing symptoms of narcolepsy (i.e., daytime somnolence). Its precise     mechanism of action in promoting wakefulness remains unclear. This trial is a     placebo-controlled double-blind trial of modafinil, on a platform of contingency management     (CM) and individual cognitive-behavioral (CBT) counseling, for the treatment of     methamphetamine dependence. Participants in this study will complete a 2-week baseline     screening period during which they will provide urine samples and complete physical and     psychological assessments to establish their eligibility for the study. In addition,     participants will be asked to provide a blood or saliva specimen for genetic testing in order     to identify genetic variations that influence response to methamphetamine and to treatment     with modafinil. Upon successful completion of screening, participants will be randomly     assigned to receive either modafinil (400mg qd) or placebo during the 12 weeks of the study.     Neither the participants nor study staff will know who is receiving active medication or     placebo. Regardless of medication condition, all participants will receive CM and weekly     individual CBT counseling sessions to help them stop using methamphetamine and prevent     relapse. They will attend the clinical research site (either at the UCLA Hollywood Clinic, or     the Rancho Cucamonga site) three times per week, providing urine samples at each visit,     completing data measures, and receiving individual CBT counseling on one visit each week. At     the end of the 12-week study, the medication or placebo will be discontinued. Participants     will return to the research site approximately 30 days following medication discontinuation     for a brief health check to assess any possible lingering side effects and complete brief     data measures.   "
200097|NCT00469521|"     To determine baseline tear thickness and improvement immediately post installation of two     artificial tear solutions:(9582X) and Allergan Refresh Tears.   "
200098|NCT00469534|"     A Pilot Study Evaluating Minimized Time to Beam Hypofractionated IMRT with PET Assisted     Target Definition in Patients with High Grade Gliomas      The aim of this pilot project is to explore the feasibility of combining a simple conformal     plan (Phase I) with an IMRT treatment approach (Phase II) for high grade glioma patients with     the aim of starting the RT as soon as possible following the patient's first outpatient visit     (thus, minimized 'time to beam'). It is hoped that the rapid treatment start with the initial     3D CRT plan will lessen clinical deterioration due to the growth of these aggressive tumours.     The use of Linac-based IMRT in Phase II of the patient's treatment plan will maintain the     benefit of the sophistication of IMRT.      Using novel PET imaging we also hope to better characterize regions of glioma cells thus     producing more optimized planning target volumes (PTVs) for each patient and decreasing the     volume of normal brain irradiated with the aim of minimizing radiation toxicities. Hopefully     this planning and treatment approach will provide an improvement in the quality of life and     outcome for high grade glioma patients.   "
200099|NCT00469547|"     The purpose of this study is to look at the safety and acceptance of using a microbicide     (product that kills germs) gel to clean the genital area. Microbicide gel is used by hospital     workers to clean their hands to kill germs. Researchers hope to use information from this     study to conduct a larger study to determine if the microbicidal gel protects men against     sexually transmitted infections, including HIV. Thirty healthy uncircumcised Kenyan men, 18     years and older, working in the fishing industry in Kisumu will be recruited. Participants     will complete a questionnaire about their background and sexual practices. A researcher will     conduct a detailed examination of the genital area with a magnifying glass. A blood and urine     sample will be collected to test for infection. Each participant will use both the     microbicidal gel and a placebo (contains no active ingredient) gel at different times during     the study, and the results will be compared. Volunteers will participate up to 8 weeks.   "
200100|NCT00469560|"     Open label, single arm study on Deferasirox treatment in MDS patients with chronic     transfusional hemosiderosis.      Patients receive daily oral dosis of Deferasirox in order to eliminate the quantity of iron     administered during transfusions and, if needed, to reduce the overload of already present     iron.      After an screening phase in which patients are evaluated according to eligibility criteria, a     one year treatment phase foresees monthly visits to evaluate safety and efficacy signs.   "
200101|NCT00469573|"     The purpose of this study is to determine if Optive®eye drops are safe for people who wear     contact lenses and have dry eyes. The second goal of the study is to determine if using     Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).   "
200102|NCT00469586|"     This trial is conducted in Europe, Asia, North America and South America. The aim of this     research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin     combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of     use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).   "
200103|NCT00469599|"     The purpose of this study is to compare alfacalcidol and paricalcitol in the treatment of     secondary hyperparathyroidism in hemodialysis patients.   "
200104|NCT00469612|"     The purpose of the present study is to carry out a trial to evaluate the clinical efficacy of     the NeuroVision Low Myopia Treatment.      The specific questions to be answered are:        1. Is there an improvement in vision following the treatment without bringing about a          change in the subject's prescription for glasses?        2. Can any treatment effect be seen at 6 months and 12 months after the termination of the          treatment?   "
200105|NCT00469625|"     Diabetic Nephropathy and other proteinuric renal diseases are the major cause of kidney     disease in the United States. The degree of proteinuria is associated with risk for renal     disease progression and cardiovascular outcomes. Deficiency of 1-25 Vitamin D develops early     in CKD, and is undertreated. Vitamin D may have important effects on factors that drive     proteinuria and renal disease progression in patients with proteinuric renal diseases.     Therefore, Paricalcitol treatment may reduce proteinuria and slow renal deterioration.   "
200106|NCT00469638|"     To prove if the success rate of curative treatment of atrial fibrillation in left atrial     circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer     giving access to the left atrium then by using a conventionally introducer with fixed curve.   "
200123|NCT00469872|"     This study will compare two treatment approaches that are currently being used for children     with cerebral palsy. Both treatments aim to improve a child's function. The two approaches     being compared are: 1) improving function by working with the child to improve his/her skills     and abilities (child-focused approach) and 2) improving function by changing/adapting the     task and/or environment around the child to improve his/her skills and abilities     (context-focused approach). It is hypothesized that the context-focused approach will     significantly improve activity and participation outcomes while leading to no significant     decreases in body function and structure outcomes.   "
200124|NCT00469885|"     This study evaluates the effect of smoking reduction vs usual care (quitting advice only) for     individuals with peripheral arterial disease who smoke.   "
200107|NCT00469651|"     This study will evaluate the safety of candidate malaria vaccine MSP3 in children aged 12-24     months in Tanzania in a highland area with low malaria transmission.      Written informed consent will be sought from all guardians/parents of potentially     participating children. Eligible children will be randomly allocated to receive either the     the study vaccine (MSP3 for a total of 30 children)) or the control vaccine (hepatitis B for     a total of 15 children). The vaccines will be given in 3 immunizations one month apart to all     the study children and neither the clinical investigators nor the children's parents will be     aware of which vaccine has been administered during the initial four months of the study. The     study is designed to begin with a lower dose of the MSP3 vaccine (15µg of MSP3 for 15     children) and then followed by the higher dose(30µg MSP3 for 15 children). Following each     immunization, children will be evaluated for a seven day solicited symptoms. Unsolicited     symptoms will also be collected throughout the study duration.      The study will be overseen by an international safety monitoring committee who will follow     safety matters closely as the trial progresses. The study will also be approved by the     Tanzania National ethics Committee, The Tanzania Food and Drugs Authority, and the London     school of hygiene and tropical medicine ethics committee. The study is planned to last 13     months for each participant.   "
200108|NCT00469664|"     Our overall aim is to determine if the administration of guanfacine in combination with     aripiprazole, olanzapine, quetiapine, and/or risperidone is significantly more effective than     any of those medications alone in treating some of the cognitive impairment in schizophrenia.   "
200109|NCT00469690|"     The purpose of this study is to compare the ability of two different topical NSAIDs     (non-steroidal anti-inflammatory medications used for pain relief) to reach the back of the     eye and to stop inflammation. The study will conclude on the day of your cataract surgery.   "
200110|NCT00469703|"     The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating     patients with chronic pancreatitis.   "
200111|NCT00469716|"     Cardiopulmonary bypass(CPB) is associated with increased fluid extravasation and edema     formation. A continuous infusion of a mixture of hypertonic saline/hydroxyethyl starch     (HSH)during CPB reduced fluid extravasation and total fluid gain during bypass in an animal     model. We hypothesize that a continuous infusion of HSH will reduce fluid load and increase     hemodynamic and respiratory functions in patients undergoing coronary artery bypass with CPB.   "
200112|NCT00469729|"     The purpose of this study is to determine the efficacy and safety of transplanting StemEx® in     patients with certain hematological malignancies. For these patients, it is suggested that     StemEx® can improve upon the outcome of transplanting a single, unmanipulated cord blood unit     by significantly increasing the number of stem/progenitor cells available to the patient.   "
200113|NCT00469742|"     This is a retrospective chart review study. The purpose of this study is to review our     experience at Children's Healthcare of Atlanta in neonates receiving aprotinin. We will     examine the specific outcomes of renal dysfunction, thrombosis and mortality.   "
200114|NCT00469755|"     To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1%     compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment     with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream   "
200115|NCT00469768|"     IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in     Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from     matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess     safety and tolerability compared to placebo   "
200116|NCT00469781|"     The objective of this study is to determine if twice-daily dosing of prednisolone (Pred     Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of     retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly     with twice-daily bromfenac.   "
200117|NCT00469794|"     Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The     aim of the study is to investigate the relevance of ventricular tachyarrhythmias induced by     an exercise test in a retrospectively evaluated athletic population.   "
200118|NCT00469807|"     In this study, we have assessed the potential prognostic value for gestational outcome of     maternal ghrelin levels at very early stages of IVF pregnancies. In addition, ghrelin     responses to meal intake were explored at early gestation.   "
200119|NCT00469820|"     RATIONALE: Vaccines made from the patient's cancer cells may help the body build an effective     immune response to kill cancer cells. Giving vaccine therapy together with donor lymphocyte     infusion after a stem cell transplant from the patient's brother or sister may kill any     cancer cells that remain after transplant.      PURPOSE: This clinical trial is studying the side effects, best dose, and how well vaccine     therapy with or without donor lymphocyte infusion works in treating patients with acute     myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma undergoing donor stem     cell transplant.   "
200120|NCT00469833|"     The objective of this project is to understand defects in insulin secretion that contribute     to abnormal glucose metabolism in patients with diabetes. In particular the effects of     signals released from the intestine to stimulate insulin secretion will be tested. Patients     with type 2 diabetes will have insulin secretion in response to glucose and intestinal     factors before and after insulin treatment to lower their blood glucose. It is expected that     the results of this work will provide valuable information for treating diabetic people.   "
200121|NCT00469846|"     This study is intended to assess the efficacy of L-arginine supplementation with antioxidant     vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk     population.   "
200122|NCT00469859|"     RATIONALE: Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cytarabine and idarubicin, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving lestaurtinib together with cytarabine and idarubicin may     kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of lestaurtinib     when given together with cytarabine and idarubicin and to see how well they work in treating     younger patients with relapsed or refractory acute myeloid leukemia.   "
200171|NCT00470509|"     The purpose of this study is to determine whether adalimumab (a TNF-alpha inhibitor) is     effective in the treatment of severe and acute sciatica.   "
200125|NCT00469898|"     RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have     been very encouraging. As the toxicity profile associated with carboplatin is preferable over     cisplatin it is our expectation that patients and physicians would prefer to use this     combination if it is equally or more efficacious. To date there has been no agreement     regarding the optimal combination of these agents. Based on the trials described in the     protocol and our experience with carboplatin/irinotecan in the treatment of non-small cell     lung cancer the present trial will utilize a 21-day cycle of irinotecan 50 mg/m2 given on     days 1 and 8 and carboplatin AUC 5 (based on the Calvert formula) on day 1.      PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin     works as first-line therapy in treating patients with extensive-stage small cell lung cancer.   "
200126|NCT00469911|"     Cardiovascular disease is the leading cause of death in patients with diabetes mellitus (DM),     with atherosclerosis accounting for approximately 80% of the cases. Although the cause for     the increased cardiovascular risk is multi-factorial, there is compelling evidence obtained     from experimental models of DM suggesting that excessive myocardial lipid uptake may be     contributory. This ectopic deposition of lipid, often stored as triacylglycerol (TAG) may     directly cause myocardial damage and decreased function through a variety of mechanisms.     However, accurate translation of these findings to humans with DM, requires an noninvasive     imaging method that provides both accurate and reproducible measurements of myocardial tissue     TAG. Currently, no such imaging method exists.   "
200127|NCT00469924|"     Patients in hospitals may develop serious problems that are detected by blood tests. It is     very important for the physicians to be notified of these abnormal blood tests as soon as     possible. Currently, this is done using phone calls from the lab to the nurse. The nurse then     pages the doctor and waits for a call back. We are conducting a study using an automated     paging system that immediately alerts the physician directly. We will test whether the     automated system affects the time for the physician to respond to the abnormality. If the     physician's patient has a serious laboratory result, we will automatically send this     laboratory result to the physician's PDA. We will also provide guidelines for treating the     patient. These guidelines will come from existing hospital policies where available, or from     local expert opinion. We will determine whether patients get better and faster care because     of the automated alerting system.   "
200128|NCT00469937|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as     lithium, may protect normal cells from the side effects of radiation therapy. Giving lithium     together with radiation therapy may allow a higher dose of radiation therapy to be given so     that more tumor cells are killed.      PURPOSE: This phase I trial is studying the side effects and best dose of lithium when given     together with whole-brain radiation therapy in treating patients with brain metastases from     primary cancer outside the brain.   "
200129|NCT00469950|"     The Efector study is an open, randomized and controlled trial assessing the effect of regular     exercise training on endothelial function, inflammatory markers, progression of disease,     heart rate variability and mental health in patients who have been successfully treated with     percutaneous coronary intervention and stent implantation for angina pectoris.   "
200130|NCT00469963|"     RATIONALE: Specialized internal radiation therapy that delivers a high dose of radiation     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This clinical trial is studying how well internal radiation therapy works in     treating patients with primary liver cancer that cannot be removed by surgery.   "
200131|NCT00469976|"     RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as bevacizumab, can block tumor growth in different ways. Some block the ability of     tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Giving enzastaurin together with carboplatin and     gemcitabine, with or without bevacizumab, may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving enzastaurin together with     carboplatin and gemcitabine, with or without bevacizumab, works in treating patients with     recurrent, stage IIIB, or stage IV non-small cell lung cancer.   "
200132|NCT00469989|"     There has been considerable debate over the last 30 years about the interaction between     asthma and parasitic infection. It has been suggested that at least part of the reason for     the increasing prevalence of asthma in the developed world is a decrease in parasite     infections resulting from improved living conditions with economic development. Our previous     studies in Ethiopia suggest that hookworm infection may be particularly important in this     process.      To establish definitively whether parasites can protect against allergic disease, and     specifically asthma, ultimately requires a randomised clinical trial of parasite infection in     patients with asthma. We, the researchers at the University of Nottingham, have completed a     study in normal volunteers to establish the dose of hookworms necessary to generate infection     at the level shown to be protective in population surveys, and shown that infection is well     tolerated. In addition, we have recently completed a randomized placebo-controlled clinical     trial of hookworm infection in allergic patients with rhinitis which showed that there was no     negative effect on bronchial responsiveness during the phase in the lifecycle where the     hookworm larvae migrate through the lungs. Consequently, are now proceeding with the     definitive randomized placebo-controlled trial of hookworm infection in people with asthma.     This study will also provide us with the opportunity to investigate the cellular mechanisms     of the effect of hookworm infection on the immune system.   "
200133|NCT00470002|"     The purpose of the study is to determine whether the treatment with growth hormone has an     influence on the nitric oxide pathway in healthy males.   "
200134|NCT00470015|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of     immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white     blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in     incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy     together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with     stage II, stage III, or stage IV melanoma.   "
200135|NCT00470028|"     This is a study to assess the effectiveness and safety of repetitive transcranial magnetic     stimulation (rTMS) as a treatment for depressed 13-18 year olds.      In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of     the brain depolarizing neurons. No anesthetic is required and the treatment in subconvulsive.     Recent studies suggest that rTMS can be an effective treatment for depressive illness in     adults (Loo and Mitchell, 2005) and appears to be quite safe.      Minimal data of TMS use in adolescents psychiatric disorders. Data only existed in seven     patients of the four that were depressed two showed improvement in their depression     (Quintana, 2005). No sham-controlled studies have been conducted.      The investigators wish to assess this in a sham-controlled study of 30 adolescents. The     investigators hypothesize that rTMS will have an antidepressant effect and produce no     neuropsychological impairment.   "
200136|NCT00470041|"     Description: To investigate bioavailability of two anti-viral drugs (lamivudine and     zidovudine) from a new oral formulation (trial formulation) especially designed for pediatric     use.      Interventions: 12 healthy volunteers will receive in a cross-over design two formulations     i.e. the commercially available tablet formulation and the trial formulation. Blood samples     (13 over 24 h) will be taken in order to determine the pharmacokinetic profile of the drugs     from both formulations and will be compared.      Duration of intervention: 2 days + 7 days of wash-out between both oral administrations.   "
200137|NCT00470054|"     This phase II trial is studying how well dasatinib works in treating patients with relapse     small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
200138|NCT00470067|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome     together with carboplatin works in treating patients with recurrent, stage III, or stage IV     primary endometrial cancer.   "
200139|NCT00470080|"     This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral     sucrose solution compared to oral sucrose solution alone before venepuncture in preterm     infants.   "
200140|NCT00470093|"     RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-6 may     stimulate the white blood cells to kill cancer cells. Giving interferon alfa together with     interleukin-6 may kill more cancer cells.      PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa     together with interleukin-6 works in treating patients with recurrent multiple myeloma.   "
200141|NCT00470106|"     Veterans with schizophrenia and schizoaffective disorder experience very high levels of     disability and poor community outcome. Further improvements in community outcome for patients     with these disorders will not occur simply through better control of clinical symptoms.     Instead, it will be necessary to find treatments that address the key determinants of poor     functional outcome. Evidence strongly suggests that basic (non-social) cognitive and social     cognitive deficits are among the key determinants of functional outcome for these illnesses.     The primary goal of this 2-year pilot study is to implement and validate a new remediation     program for social cognition that is appropriate for veterans with schizophrenia and     schizoaffective disorder.   "
200142|NCT00470119|"     RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese     postmenopausal woman's risk of developing breast cancer. It is not yet known whether a     low-calorie diet and/or exercise program are more effective than no diet or exercise program     in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer.      PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or     exercise program on risk factors for developing breast cancer compared with no diet or     exercise program in overweight or obese postmenopausal women.   "
200143|NCT00470132|"     The retrospective study will help determine whether or not placement of new devices prior to     the recommended time was associated with a high risk of relapse or treatment failure.   "
200144|NCT00470145|"     SB-568859 is a medication that is being developed for the treatment of atherosclerosis     (hardening of the arteries). The purpose of this study is to see if there is a difference in     how the human body takes up the study drug depending on how the study drug is made. This     study will compare SB-568859 tablets that are made in 2 different ways. This is not a     treatment study.   "
200145|NCT00470158|"     With the long-term public health goal of developing an effective micronutrient     supplementation program to improve child health by improving iron and zinc status and     decreasing morbidity due to diarrhea in areas with high rates of childhood malnutrition, we     seek to determine the most efficacious method of decreasing childhood morbidity and mortality     due to diarrhea in toddlers by re-examining the issue of iron and zinc interaction and     determining if this interaction can be minimized by separate administration of iron and zinc     supplementation.   "
200146|NCT00470171|"     This is a phase II study with direct individual benefit. It is a randomized, double blind     placebo controlled study whose aim is to evaluate the efficacy and tolerance of     ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis.      The hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment     associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in     transaminase elevations and non-invasive markers for hepatic fibrosis A positive response is     defined as a significantly larger decrease in average ALAT levels between the time of     inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as     compared to the placebo group.      The duration of the study will be 12 months. An end of treatment evaluation (EoT) will take     place at the end of the 12th month of treatment.   "
200147|NCT00470184|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     chemotherapy together with radiation therapy before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine     together with radiation therapy works in treating patients undergoing surgery for stage II,     stage III, or stage IV esophageal cancer.   "
200148|NCT00470197|"     Drugs used in chemotherapy, such as flavopiridol, cytarabine, and mitoxantrone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving a new schedule of more than one drug (combination chemotherapy)     may kill more cancer cells. This phase I trial is studying the side effects, best dose, and     best schedule for flavopiridol when given together with cytarabine and mitoxantrone in     treating patients with relapsed or refractory acute leukemia.   "
200149|NCT00470210|"     This trial will assess the sustained virologic response to treatment with peginterferon     alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected     patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase     elevations. These patients will have been nonresponders to previous regimens with     peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.   "
200150|NCT00470223|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Zoledronic acid may stop the     growth of tumor cells in bone. Giving chemotherapy with or without zoledronic acid before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed. Giving these treatments after surgery may kill any tumor cells that remain after     surgery. It is not yet known whether giving combination chemotherapy together with zoledronic     acid is more effective than combination chemotherapy alone in treating osteosarcoma.      PURPOSE: This randomized phase III trial is studying combination chemotherapy and zoledronic     acid to see how well they work compared with combination chemotherapy alone in treating     patients with osteosarcoma.   "
200151|NCT00470236|"     Hypotheses:        1. The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the          risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast).        2. The risk of local recurrence in the shorter fractionation arm is not worse than that for          the standard fractionation arm.        3. A molecular signature predictive of invasive recurrence of DCIS will be detectable and          the molecular signature may eventually have clinical utility for therapy          individualization.      Overall Objectives:        1. To improve the outcome of women with non-low risk DCIS treated with breast conserving          therapy.        2. To individualize treatment selection for women with DCIS to achieve long term disease          control with minimal toxicity.   "
200152|NCT00470249|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving carboplatin together with     gemcitabine works in treating patients with locally advanced or metastatic breast cancer.   "
200153|NCT00470262|"     The relationship between obesity and insulin resistance is known, however the mechanism(s)     associating obesity with insulin resistance is not well understood. Inflammation and     accumulation of fat in non fat tissue (like muscle) are conditions found on obesity which     could be the potential link between obesity and insulin resistance. This study is designed to     test the effects of two different drugs on numerous features of the obesity and insulin     resistance in subjects with impaired glucose tolerance. Impaired glucose tolerance is a     condition where blood sugar is too high after drinking a sugary drink containing 75 grams of     sugar. Impaired glucose tolerant subjects are insulin resistant and at risk of developing     diabetes. The drugs to be used are fenofibrate and pioglitazone. Fenofibrate is used to     reduce the amount of fat (triglycerides) in the blood while pioglitazone is routinely used to     make the body more sensitive to insulin in patients with diabetes. The purpose of this study     is to compare the effects of either of these two medications (pioglitazone and fenofibrate)     alone or the combination of both on fat accumulation in body (muscle) and inflammation. The     amount of fat accumulation in muscle is thought to affect insulin sensitivity. In addition,     the changes in the level of proteins produced by fat tissues will be studied in response to     the two medications in this study. These proteins are thought to be involved in diabetes and     insulin resistance.      These studies are designed to examine fundamental clinical mechanisms underlying the     metabolic syndrome and diabetes.   "
200154|NCT00470275|"     RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well cytarabine works in treating young patients     with recurrent or refractory Ewing's sarcoma.   "
200155|NCT00470288|"     Objective: To compare outcomes in cesarean section patients undergoing bladder flap versus     none. Hypotheses: Operative time will be reduced with the elimination of a bladder flap     during cesarean delivery and intra-operative and post-operative morbidity will not be     significantly different.      Patients >= 35 wks gestation undergoing cesarean delivery will be randomized to bladder flap     vs. none. Primary outcome is operative time (start to delivery); secondary outcomes include:     injuries, EBL, intra-operative and post-operative complications,pain medication, hospital     stay duration.   "
200156|NCT00470301|"     Tipifarnib may stop the growth of breast cancer by blocking some of the enzymes needed for     cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as     paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib     together with combination chemotherapy may kill more tumor cells. This phase I/II trial is     studying the side effects and best dose of tipifarnib when given together with combination     chemotherapy and to see how well they work in treating patients with stage II or stage III     breast cancer.   "
200157|NCT00470314|"     The purpose of the study is to determine whether L-Ornithine L-Aspartate infusion improves     the survival of patients with acute liver failure.   "
200193|NCT00470808|"     Diabetes is a highly atherogenic disease. Pomegranate juice has impressive antioxidant     properties. It has been proven to decrease oxidant stress and to cause the regression of     atherosclerotic plaques in hypercholestrolemic and diabetic patients.Furthermore it has been     proven to potentiate the biologic activity of the enzyme paraoxonase 1 which is very     important in preventing atherosclerosis. The study will try to prove that a polyphenolic     extract from pomegranate (POMx) has the same desired effects.   "
200158|NCT00470327|"     The purpose of this study is to obtain information on all patients being cared for by the ILD     program in an effort to better understand the natural course of these diseases. Hopefully     getting this information will lead to a better understanding of how these diseases behave     with time. This in turn, will let physicians' better treat patients in the future.      Another goal of the study is to be able to see if in the future a patients' genetics can be     linked to the type of disease they have and the way it behaves. We do not yet know what that     may be. Our goal is to study this in aggregate rather than in any individual patients. Which     genes to study are also unclear. But the only hope of having a clearly defined group to match     the genetics to in the future requires that we obtain samples now in conjunction with     collecting the data on the disease progression.   "
200159|NCT00470340|"     Besides liver transplantation, the curative treatment of primary hepatic cancer with     cirrhosis remains the surgical resection. Radiofrequency or cryotherapy currently allow local     ablation of small cancer, with very good results. However, all these treatments are followed     by high rates of recurrence (50 - 70% at 5 years). Then, it seems essential to associate to     the surgical resection or to the local ablation as adjuvant treatment, in order to prevent     or to decrease the rate of recurrence. However, no evidence supports this attitude.     Therefore, following curative treatment of primary hepatic cancer with cirrhosis, we propose     to compare treated to untreated patients. Postoperative treatment means either intra-arterial     chemotherapy or systemic chemotherapy. The main criterion of the study is time of survival     without recurrence. The main secondary objective is the safety.   "
200160|NCT00470353|"     RATIONALE: The use of cholecalciferol and calcium carbonate may keep colon cancer from coming     back in patients with colon cancer that has been removed by surgery.      PURPOSE: This randomized clinical trial is studying two different doses of cholecalciferol to     compare how well they work when given together with calcium carbonate in treating patients     with colon cancer that has been removed by surgery.   "
200161|NCT00470366|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune     cells found in bone marrow or peripheral blood and may help the immune system recover from     the side effects of chemotherapy.      PURPOSE: This phase II trial is studying the side effects and how well giving combination     chemotherapy together with pegfilgrastim works in treating patients with previously untreated     germ cell tumors.   "
200162|NCT00470379|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells. Giving vaccine therapy together with resiquimod may make a stronger     immune response and prevent or delay the recurrence of cancer.      PURPOSE: This clinical trial is studying the side effects, best dose, and best way to give     vaccine therapy together with resiquimod in treating patients with stage II, stage III, or     stage IV melanoma that has been completely removed by surgery.   "
200163|NCT00470392|"     The purpose of this study is 1) to determine whether Imiquimod or Steroid pretreatment     modifies UVB laser light response resulting in increased cell death compared to UVB laser     light alone; 2) to determine if pretreatment of psoriatic lesions with Imiquimod or Steroid     prior to UVB laser light exposure selectively effects various T cell functions; 3) to     determine clinical results from the Imiquimod/Steroid/UVB laser light and correlate those     changes with immuno-histochemical changes in the skin; and 4) to determine if single high     dose lesion limited UVB laser light intervention combined with Imiquimod or Steroid     influences T cell changes   "
200164|NCT00470405|"     RATIONALE: Pemetrexed may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving pemetrexed together with oxaliplatin may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed given     together with oxaliplatin in treating patients with metastatic solid tumors or lymphoma.   "
200165|NCT00470418|"     The purpose of this study is to evaluate the safety and efficacy of NIC5-15in the treatment     of Alzheimer's Disease.   "
200166|NCT00470444|"     A high proportion of patients having cardiac surgery receive red cell transfusions. Yet, the     investigators do not know whether transfusions are beneficial and they may be associated with     harm. It is thus important to determine when a transfusion is required. The investigators     will conduct a small pilot study at St. Michael's Hospital to address this issue. Patients     having cardiac surgery will be allocated to one of two transfusion strategies with endpoints     being compliance with the transfusion strategy and clinical outcome. The results of this     study will be used to design a large definitive multicentered trial of these two transfusion     strategies.   "
200167|NCT00470457|"     Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated     allergies. The disadvantages of SIT, however, are the requirement of numerous allergen     administrations over three to five years, and that the treatment itself causes frequent     allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting     the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety     and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract     injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54     injections over 3 years.        -  Trial with immunodulatory product / biological   "
200168|NCT00470470|"     This phase II trial is studying how well imatinib mesylate works in treating patients with     stage III or stage IV melanoma that cannot be removed by surgery. Imatinib mesylate may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
200169|NCT00470483|"     To compare by neuroimaging techniques the way Social Anxiety patients respond to public     speaking before and after a drug administration   "
200170|NCT00470496|"     This phase I trial studies the side effects and best dose of photodynamic therapy using HPPH     in treating patients who are undergoing surgery for primary or recurrent head and neck     cancer. Photodynamic therapy (PDT) uses a drug, such as HPPH, that becomes active when it is     exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving     photodynamic therapy after surgery may kill any tumor cells that remain after surgery.   "
200172|NCT00470522|"     The treatment of systemic lupus erythematosus (SLE) has been aimed at decreasing mortality     and morbidity because the etiology of the disease is unknown. The general aim of this     multicentre randomized placebo-controlled trial of low dose intermittent methotrexate with     folic acid is to establish whether methotrexate shows efficacy and safety in controlling     disease activity in SLE and preventing flares in disease activity or development of end-organ     damage. A second aim will be to document the steroid sparing effect of methotrexate in SLE. A     Third aim will be to measure toxicity and utility of methotrexate with folic acid and to     perform effectiveness and utility analyses.   "
200173|NCT00470535|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with     stage III or stage IV pancreatic cancer.   "
200174|NCT00470548|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Pemetrexed may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized     nanoparticle formulation together with pemetrexed may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel     albumin-stabilized nanoparticle formulation when given together with pemetrexed and to see     how well they work in treating patients with advanced non-small cell lung cancer, breast     cancer, or other solid tumors.   "
200175|NCT00470561|"     RATIONALE: Aspirin may be effective in reducing breast density in healthy postmenopausal     women with a moderate or high level of breast density.      PURPOSE: This randomized clinical trial is studying the effect of aspirin on mammogram     density compared with a placebo in healthy postmenopausal women with a moderate or high level     of breast density.   "
200176|NCT00470574|"     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.     Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more     tumor cells.      PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy     together with QS21 works in treating patients with metastatic breast cancer.   "
200177|NCT00470587|"     The triage of patients with suspected acute coronary syndrome in the emergency room is a     time-consuming diagnostic challenge. Therefore high sensitive early markers for myocardial     damage are needed for more rapidly rule out of acute myocardial infarction (AMI) - especially     for the first 3 to 4 hours after onset of chest pain in AMI (troponin-blind period).      Therefore we test the hypothesis that the use meticulous patient history and novel cardiac     markers can provide a faster detection or exclusion of AMI in patients presenting with acute     chest pain to the emergency department.      The prospective cohort study is designed to enrol patients presenting with acute chest pain     at rest within the last 12 hours to the emergency department. Several blood samples for     detection of the new markers will be drawn and compared with the gold standard for the     diagnosis of AMI (high-sensitivity cardiac troponin T). All patients will be contacted by     telephone at 3, 12, 24 and 60 months to determine functional status, major adverse cardiac     events (death, myocardial infarction, coronary artery bypass grafting, percutaneous coronary     intervention), and the results of cardiac examination (stress test, coronary angiography) if     performed.   "
200178|NCT00470600|"     The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative     hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine     the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of     post-operative pain by patients self-assessment of pain.   "
200179|NCT00470613|"     This is a Phase Ib study as a continuation of the original Phase I protocol. The purpose of     this Phase Ib study is to evaluate the safety of a single course of SGT-53 in combination     with docetaxel and determine the recommended Phase II doses of SGT-53 and docetaxel in     combination for evaluation in subsequent clinical studies for the treatment of solid tumors.   "
200180|NCT00470626|"     The clinical study will collect data to verify the safety and performance of the Cook Celect     Filter in the prevention of pulmonary embolism (PE) in patients with a temporary or permanent     high risk of thromboembolism.   "
200181|NCT00470639|"     This is a study to assess the effectiveness of repetitive transcranial magnetic stimulation     (rTMS) as a treatment for depressed adults with bipolar disorder.      In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of     the brain depolarising neurons. No anaesthetic is required and the treatment in     subconvulsive. Recent studies suggest that rTMS can be an effective treatment for depressive     illness in adults (Loo and Mitchell et al, 2005) and appears to be quite safe.      Most of the published studies to date have focused on unipolar depression. There is limited     data of TMS use in bipolar depression. Eg. Pilot study by Nahas Z, Kozel FA, Li X, Anderson     B, George MS.in 2003, which was negative.      The investigators wish to assess this in a sham-controlled study of adults. The investigators     hypothesise that both left and right sided rTMS will have an antidepressant effect superior     to sham in this population.   "
200182|NCT00470652|"     Oligoanalgesia1 has been widely recognized as an issue in emergency department.The purpose of     our study is to assess the impact of the implementation of a computer-assisted support     program to improve pain management in our ED.   "
200183|NCT00470665|"     The purpose of this study is to assess whether in high-risk kidney transplant patients     (patients whose previous kidney transplant failed, have a high PRA lab test result or are of     African-American descent) that a combination of Rapamune with Prograf and steroids will     prevent acute rejection as well as Rapamune and cyclosporine and steroids.   "
200184|NCT00470678|"     This study will evaluate efficacy and safety for monthly ranibizumab 0.5 mg intravitreal     injections in Asian patients with subfoveal choroidal neovascularization secondary to     age-related macular degeneration.   "
200194|NCT00470821|"     Sleep disruptions are extremely common in high-risk critically ill patients. The     investigators want to analyse oral melatonin potentialities as a sedative and a free-radicals     scavenger for critically ill patients, and secondarily for preventing Delirium during their     ICU stay and post-traumatic stress disorders after ICU discharge.   "
202452|NCT00499876|"     The purpose of this study is to find out whether malaria affects how HIV/AIDS disease     progresses in an infected patient, and to determine the effect of reducing malaria infection     on HIV disease progression in Kumasi   "
200185|NCT00470691|"     At our hospital, all Colles' fractures deemed suitable for conservative treatment are reduced     and immobilised with a plaster of Paris dorsal splint which is converted to a complete cast     after 10 days. According to individual factors such as age, general health and radiological     results after 10 days, some patients with severe redisplacement are readmitted to hospital     for surgery.      The main purpose of this study is to determine whether, during the first 10 days of     immobilisation, a complete plaster cast or a dorsal plaster splint best retains the alignment     of a reduced Colles' fracture. In addition, we aim to compare the complication rates of the     two methods.   "
200186|NCT00470704|"     In this research study we are studying the effects of the combination of lapatinib plus     Herceptin in subjects with breast cancer that has spread outside of the breast. We are also     studying whether positron emission tomography (PET/CT) scans can predict which participants     will benefit from the study treatment. Finally, we are studying genes and proteins in the     tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination     of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing.     Other research studies suggest that lapatinib in combination with Herceptin may help to     shrink or stabilize breast cancer.   "
200187|NCT00470717|"     1. The first aim of this proposal is to pilot the feasibility of weekly phone monitoring of          infant feeding and illness patterns in a socio-economically and racially diverse          population. Specifically, the investigators aim to estimate the rate of group loss to          follow up from birth to 13 weeks (3 months) of age with weekly phone interview of          mothers of late preterm (LPT, gestational age 34 0/7- 36 6/7 weeks gestation) infants.        2. The second aim is to describe breastfeeding and formula feeding practices, and rates of          illness and post-discharge hospital care utilization, through age 13 weeks (3 months)          among late preterm infants born at MacDonald Women's Hospital. The investigators          estimate that the rate of exclusive breastfeeding among LPT infants at 3 months of age          is less than the documented rate of 37% for all infants in Cuyahoga County.   "
200188|NCT00470743|"     The purpose of the study is to determine the safety and efficacy of ibuprofen, compared with     indomethacin, in the treatment for the closure of the patent ductus arteriosus in premature     babies born under 29 weeks gestation   "
200189|NCT00470756|"     Every week we encounter with 5-8 pairs of worried parents of infants with forefoot adduction.     Most of them usually need only reassurance and education how to manipulate the deformed foot.     During the examination we usually use provocative maneuver to trigger peroneal activity. This     manual stimulation usually reveals active eversion and dorsiflexion of the foot in most of     the children, but not in all of them. Small part of the children reacts in opposite direction     - instead of the typical eversion they demonstrate inversion and some plantar flexion of the     foot. We have the impression that this subgroup of children improves the deformity slower and     sometime less complete than most of the children. We did not find in the literature any     description of this phenomenon. We postulate, that atypically reacting patients probably have     different response due to abnormalities of neuromuscular balance between invertors-flexors     and evertors-extensors muscle groups. This small subgroup of children may need more close     follow-up and probably casting to speed up and secure the improvement of their deformity.      Study goals:        1. Evaluate ability of children with FFA to respond on mechanical triggering of peroneal          activity             1. The majority of the patients with standard reaction - foot dorsiflexion and               eversion (evertors)             2. The minority of the patients with nonstandard reaction - foot plantarflexion and               inversion (invertors)        2. Evaluate randomly selected children from each group for character of muscular response          on electrical stimulation (EMG) of calf muscles.   "
200190|NCT00470769|"     It is generally assumed that renal blood flow is symmetric in the absence of renal artery     stenosis. The importance of studying the function of both kidneys separately is because it     cannot be assumed that they are functionally equal.The aim of the present study is to     evaluate whether this is really in patients with essential hypertension and/or moderate     kidneys loss.   "
200191|NCT00470782|"     Recent studies have shown that survival after a colorectal cancer diagnosis may be affected     by a person's activity level and body size. This research says that for colorectal cancer     patients, the less active and more obese they are, the more likely they are to have a cancer     recurrence or die from their cancer. Chemotherapy has been shown to reduce activity levels,     fitness, and body size in some cancer patients. However, it is not known how chemotherapy     specific for colon cancer patients affects their activity levels, fitness, and body size. The     main goal of our study will be to look at how chemotherapy treatments affect the fitness,     activity levels, and body size in colon cancer patients. In order to do this, we will measure     these variables before chemotherapy treatments, and at 1 and 6 months following the end of     treatment. Our results will show how chemotherapy affects fitness, activity levels, and body     size in colon cancer patients and provide data to help in designing an exercise intervention     specifically for colon cancer survivors.   "
200192|NCT00470795|"     Gastroparesis is a common complication of prolonged diabetes mellitus, both with Type 1 and     Type 2 forms. Treatment of diabetic gastroparesis ranges from changing dietary habits to     medications and invasive procedures, all of which offer only partial and transient relief,     with some options having potentially harmful effects. Acupuncture is an ancient treatment     which has been found to be beneficial for many ailments, including those involving the     gastrointestinal tract. We propose to evaluate whether acupuncture is an effective and safe     treatment for diabetic gastroparesis using a randomized, double-blind,     placebo/sham-controlled crossover trial. Because symptoms of gastroparesis do not correlate     well with objective tests of gastric emptying (i.e., scintigraphy or 13C breath tests), our     primary outcome value will be the Gastroparesis Cardinal Symptom Index (GCSI), a reliable and     validated instrument for quantifying symptoms in these patients. As a secondary outcome we     will measure gastric emptying using a C13-acetate breath test, as well as the SF-12 Short     Form Health Survey. Blinding of the participants will be evaluated using a Validation of     Blinding Questionnaire at the end of the treatment period.      Diabetic patients suffering from moderate gastroparesis (total GCSI score > 2.50) who fulfill     the inclusion criteria (and none of the exclusion criteria) will be eligible to participate     in the study. On induction, participants will fill out the GCSI questionnaire and SF-36     survey, and will undergo a C13-acetate breath test. They will then be randomly assigned to     either true acupuncture treatment or placebo/sham acupuncture treatment. Each participant     will undergo 8 treatments twice-weekly, for a period of 4 weeks. At the end of the eighth     treatment session, each participant will again fill out a GCSI questionnaire and SF-12 form,     as well as repeating the C13-acetate breath. Following a 4-week washout period, patients will     be crossed over to either placebo/sham or true acupuncture treatment, again 8 twice-weekly     treatments, for a period of 4 weeks. At the end of the second treatment regimen all     participants will again fill out a GCSI questionnaire and SF-12 form, and undergo a     C13-acetate breath test. At the end of the second treatment regimen participants will again     fill out a Validation of Blinding Questionnaire.   "
200195|NCT00470834|"     Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male     hormone that leads to benign prostate growth. By blocking the conversion of testosterone to     DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus     prolonging bicalutamide's efficacy.   "
200196|NCT00470847|"     The purpose of this research study is to determine the safety of combining lapatinib plus     radiation in patients with breast cancer that has spread to the brain. Depending upon the     participants cancer, they may also have stereotactic radiosurgery (SRS). Lapatinib s a     compound that may stop cancer cells from growing abnormally. It is thought that lapatinib     might also make cancer cells more sensitive to radiation. This drug has been used in other     research studies in women with breast cancer, and information from those other research     studies suggests that lapatinib may help to shrink or stabilize breast tumors both inside the     brain and outside the brain.   "
200197|NCT00470860|"     This study mapped the time course of forgetting among resident physicians after they use an     online learning exercise covering principles of diabetes care. Participants took a pre-test     followed by an online tutorial covering aspects of diabetes care. They then completed a     post-test on the same topics after a randomly-assigned time delay from 0 to 55 days. We     hypothesized that post-test scores after these different time delays would decline following     a curvilinear relationship with increasing time. This understanding of forgetting will inform     our selection of a time for delivering reinforcement exercises in future educational studies     among physicians.   "
200198|NCT00470873|"     The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing     surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment     of erectile dysfunction. The secondary aim of this study is to assess the influence of the     treatment with Levitra on self-esteem (depressive symptomology) in men with ED.   "
200199|NCT00470886|"     The purpose of this study is to asses the efficacy and safety of Telmisartan depending on the     use of an electronic therapy monitoring device (HelpingHand) in a real life setting and to     asses patients compliance to the therapy with Telmisartan in relation to use of electronic     therapy monitoring device.   "
200200|NCT00470899|"     Study hypothesis: umbilical cord drainage of fetal blood after delivery of the infant would     reduce the incidence of feto-maternal transfusion. Patients were randomized to placental     drainage or no drainage at the time of cesarean section. The incidence of fetal to maternal     transfusion was noted postoperatively.   "
200201|NCT00470912|"     Lupus erythematosus (LE) is characterized by a large clinical spectrum, and sunligt is a well     established factor in the induction and exacerbation of this disease. In all subsets of LE,     skin lesions occur preferentially in sun-exposed areas.      Previous studies have demonstrated that the lesions in LE patients reproduced in controlled     experimental conditions. The initial reports suggested that the action spectrum for the LE     was in the UVB range (290 to 320 nm), but more recent studies have demonstrated that UVA (320     to 400 nm) can contribute to the induction of LE skin lesions.      Antimalarial agents and topical steroids are the main treatments of chronic LE. The second     line therapies include retinoids, sulfones, immunosuppressor agents, systemic corticosteroid     and thalidomide. Moreover, patients are advised to avoid sun, to wear sunprotective clothing     and to apply sunscreen.      The aim of this study was to assess the efficacy of a sunscreen milk with high protection     factor against UV-B and UV-A, used exclusively, in the photoinduced LE.   "
200202|NCT00470925|"     The overall purpose of this project is to evaluate the effect of sertraline administration on     the binding of 123-I mZINT in 10 healthy subjects. All study procedures will be conducted at     the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New     Haven, CT.   "
200203|NCT00470938|"     Falls are a major concern for the geriatric population and represent a significant public     health problem. Various interventions are being explored to improve balance and decrease     falls in the elderly. Success has been shown in some programs; various exercise interventions     place emphasis on strength, balance, or endurance exercises. Results reported in the     literature are still equivocal. Controversy exists as to optimal types of exercise, and the     optimum frequency, duration, and intensity of exercise. It is believed that the SpineForce     device, which places a unique combination of strength and balance demands upon the user, can     result in rapid increases in balance as compared to other rehabilitation programs. Gains in     balance have implications for geriatric populations as well as those seeking enhanced sports     performance and injury prevention. The Purpose of this study is to assess the SpineForce     device as a novel intervention in the treatment of balance disorders.   "
200204|NCT00470951|"     The investigators designed the randomized prospective trial of comparing open and     laparoscopic resection in locally advanced rectal cancer after preoperative chemoradiation in     order to determine the oncologic and functional efficacy of laparoscopic rectal resection.   "
200205|NCT00470964|"     Titanium Sapphire laser trabeculoplasty is effective in lowering intraocular pressure in     glaucoma patients, and is comparable to argon laser trabeculoplasty   "
200206|NCT00470977|"     The purpose of this study is to evaluate the safety and tolerability of intravitreal     injections of ranibizumab in the treatment of AMD variants and other choroidal     neovascularization (CNV) related conditions (Coats' disease, idiopathic perifoveal     telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma     elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis) using the incidence     and severity of adverse events.      Limited forms of treatment are available that limit the loss of visual acuity. However, the     patients may not have any substantial improvement in acuity or function. Therefore there     remains a significant unmet need for therapeutic options managing the neovascularization and     its consequences.      Lucentis (ranibizumab) injection will be considered as an attempt to control the growth of     the abnormal vessels because of evidence suggesting that angiogenic factors, such as vascular     endothelial growth factor (VEGF), play a role in the pathogenesis of neovascular non-AMD     conditions.      The rationale for the study design is as follows:      A 0.5 mg dose of Lucentis (ranibizumab), a commercially available preparation that is Food     and Drug Administration (FDA) approved and labeled for intravitreal injection use for     neovascular (wet) age-related macular degeneration will be used.      In AMD variants and other CNV related conditions, vascular endothelial growth factor (VEGF)     plays a role in the pathogenesis as in neovascular AMD.      Intravitreal injection of ranibizumab delivers maximal concentration of the antibody fragment     to the vitreous cavity with minimal systemic exposure. The dosing schedule, based on     considerations of the half-life and the clinical response in patients with neovascularization     suggests that a 1-month interval is optimal.   "
200207|NCT00470990|"     Type 2 diabetes is one of the most common metabolic disorders in the U.S, estimated to affect     16 million Americans. Established risk factors for this disease include obesity, increased     waist/hip ratio, high insulin levels in the blood, and insulin resistance. Testosterone may     play a role in developing or preventing diabetes, but we do not yet know for sure. The     purpose of this research study is to determine if changing testosterone levels in men will     result in changes in insulin sensitivity. Information learned form this research study may     have important public health implications and may point to new strategies for treating or     preventing diabetes.   "
200208|NCT00471003|"     The main purpose of this study is to asses the efficacy and safety of telmisartan, with the     special attention on the influence of telmisartan on selected metabolic parameters of     patients.   "
200209|NCT00471016|"     This project is a prospective, randomized controlled trial to improve the end of life     experience for homeless persons by facilitating the expression of their wishes and     enhancement of their dignity when facing serious illness, death, or the prospect of dying.     Our main hypothesis is that homeless persons will engage in this intervention and increase     rates of advance directive completion.   "
200210|NCT00471029|"     The purpose of this study is to compare the gastric acid suppression profile among different     regimen (Oral Vs Intravenous)of administration of proton pump inhibitor - Esomeprazole by     24hours intragastric pH monitoring.   "
200211|NCT00471042|"     The purpose of this treatment research study is to assess the effectiveness of buprenorphine     maintenance treatment for opioid dependence delivered in a primary care clinic setting. This     study will determine whether buprenorphine treatment in primary care is effective in reducing     cravings, reducing illicit opioid use, reducing addiction severity, and retaining patients in     primary care treatment for opioid dependence.   "
200212|NCT00471055|"     The purpose of this study is to determine whether capsaicin gel is effective in treating mild     to moderate degrees of osteoarthritis of the knee in the elderly patient compared with     placebo gel.   "
200213|NCT00471068|"     To compare the efficacy and safety in patients treated with travoprost versus     dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular     hypertension   "
200214|NCT00471081|"     The purpose of the study is to characterize the safety and immunogenicity of 1 dose of     GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9     and 12 months of age.   "
200215|NCT00471094|"     The purpose of this study is to assess the efficacy and safety of 8 weeks of daily treatment     with Ilaprazole (5, 20 and 40 mg), once daily (QD), compared to lansoprazole 30 mg in healing     subjects with endoscopically proven erosive esophagitis.   "
200216|NCT00471107|"     This study will test the effect of direct current (DC) brain polarization (the application of     a very weak electrical current to the brain) on learning and memory. Earlier studies have     shown that DC polarization can temporarily improve the ability of healthy people to think of     certain words. This study will explore whether it can also temporarily improve learning and     memory.      Healthy people 18 years of age and older may be eligible for this study. Subjects participate     in two experimental sessions at the NIH Clinical Center. The first session lasts about 1     hour; the second session, on the next day, takes about 10 minutes.      At the beginning of the first session, electrodes are placed on the subject's head and arm     for brain stimulation. The current may be turned on for 25 minutes, or only very briefly     (sham stimulation). Subjects are not told which type of stimulation they are receiving. No     stimulation is applied in the second session.      During the sessions subjects are asked to complete the following tasks that will help     elucidate the effects of polarization:        -  Read a list of words and remember them. Later they will try to repeat the words from          memory.        -  Look at a series of designs and remember them. Later they will try to draw the designs          from memory.        -  Push a button on a keyboard when they see a specific item (for example, when the number          7 appears).        -  Generate as many words as they can think of that begin with a particular letter of the          alphabet.      Subjects may be videotaped for some or all of the time during the sessions.   "
200217|NCT00471120|"     This study aims at developing an accurate, simple, and cost-effective method for screening     and early detection of uterine cancers   "
200218|NCT00471133|"     The purpose of this study is to evaluate the safety and immunogenicity of a DNA vaccine     encoding a melanosomal antigen in melanoma patients at risk for disease progression or     recurrence. In this study, the vaccine will be administered intramuscularly using a device     that applies brief electrical fields to the tissue at the site of injection (a technique     known as electroporation). It is expected that this device will improve the delivery of the     vaccine. This study is being performed to determine if this procedure can be administered     safely and if it is capable of inducing immune responses to the vaccine.   "
200219|NCT00471146|"     The purpose of this study is to determine whether investigational study drug, AG-013736, and     gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.   "
200220|NCT00471159|"     To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel     for the treatment of patients with advanced breast cancer.   "
200221|NCT00471172|"     The aim of the study was to compare 5 methods of delivering a weight loss lifestyle     modification program to obese patients on a background of sibutramine. The methods differed     in the type and frequency of counseling utilized to deliver dietary, physical activity and     behavioral recommendations for weight loss.   "
200222|NCT00471185|"     In this study, we propose oral dosing of GIPET enhanced oral acyline (MER-104) to determine     if this potentially useful compound is safe and effective at suppression of gonadotropins     after oral dosing in man.      Hypothesis: A single dose of Acyline will suppress gonadotropins, and testosterone, estradiol     and dihydrotestosterone (DHT) for 24 hours in man, and the magnitude and duration of the     suppression will increase with increasing doses of Acyline.   "
200223|NCT00471211|"     The purpose of the study is to determine the safety, tolerability and efficacy of 2 doses of     PBT2 administered for 12 weeks compared to placebo in patients with early Alzheimer's disease     treated with an acetylcholinesterase inhibitor.   "
200224|NCT00471224|"     This protocol intends to detail investigations necessary to evaluate the ocular safety of     subjects enrolled in study A4321001 and who have received formulated Drug Product (Lot     8716-098).   "
200226|NCT00471250|"     This study will collect fluid and tissue specimens from the lungs and nose of healthy people     and people with a history of lung infections. The specimens will be examined for differences     between the two groups that may be associated with susceptibility to certain infections.      Healthy normal volunteers and people with a history of lung infections between 18 and 75     years of age who are followed at NIH may be eligible for this study.      Participants undergo the following procedures:      Medical history and physical examination.      Blood and urine tests.      Electrocardiogram (ECG) and chest x-ray.      Treadmill exercise stress test (for people over 45 years old with a history of chest pain or     ECG abnormalities).      Bronchoscopy: The subject s nose and throat are numbed with lidocaine and a sedative is given     for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth     into the lung airways to examine the airways carefully.      Fluid collection during the bronchoscopy using one of the following methods:        -  Bronchoalveolar lavage: Salt water is injected through the bronchoscope into the lung          and immediately suctioned out, washing off cells lining the airways.        -  Bronchial brushings: A brush-tipped wire enclosed in a sheath is passed through the          bronchoscope and a small area of the airway tissue is gently brushed. The brush is          withdrawn with some tissue adhering to it.        -  Endobronchial biopsies: Small pinchers on a wire are passed through the bronchoscope and          about 1 to 2 millimeters of tissue is removed.        -  Nasal scrape: A small device is used to scrape along the inside of the nose to collect          some cells.   "
200227|NCT00471263|"     The primary purpose of the study is to demonstrate a blood pressure lowering effect of     CasiGold and CasiMax in subjects with high-normal blood pressure or mild hypertension. The     secondary purpose is to collect human safety data after treatment with CasiGold and CasiMax,     to gain insight into potential mechanisms by measurement of renin and angiotensin I and II,     and to evaluate the genetic determinants of the individual BP lowering response by     measurement of specific genetic polymorphisms.   "
200228|NCT00471276|"     Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease     progression.   "
200229|NCT00471289|"     The purpose of this study is to investigate the performance of paclitaxel-coated balloon     expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and     occlusions in patients with critical limb ischemia compared to percutaneous transluminal     balloon angioplasty (PTA).   "
200230|NCT00471302|"     This study will determine the immune response to malaria infection in healthy volunteers     compared with malaria patients. Malaria affects millions of people in Mali and Africa. It can     cause fever, headaches, body aches, and weakness. Without treatment, the disease can be very     serious in children. Developing an effective vaccine against the parasite that causes malaria     is a crucial step toward controlling the disease; however, vaccines tested so far have     provided very short-lived protection. A better understanding of the natural immunity to     malaria may provide insight that can be applied to developing a more effective vaccine.      People 18 years of age or older who live in Kambila, Tieneguebougou or Kalifabougou, Mali,     and are in good health may be eligible for this study.      Participants undergo a complete physical examination at the start of the study and then once     a year for the 4-year duration of the study. They have a maximum of nine clinic visits a year     to collect blood samples for research. The visits last about one hour, including a 30-minute     observation time after the blood draw.   "
200231|NCT00471315|"     Open-label single center study of duloxetine in patients with SOD who have failed to respond     to the standard treatments.      This protocol is designed to explore the tolerability and efficacy of Duloxetine in the     management of patients with known or suspected Sphincter of Oddi dysfunction (SOD).   "
200232|NCT00471328|"     The study evaluated the safety and efficacy of nilotinib versus current treatment in adults     with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant     to the first and second line treatments.   "
200233|NCT00471341|"     This study involves a drug called celecoxib, which is commonly prescribed for people with     arthritis. Arthritis is caused by inflammation of the joints or tissues. Inflammation also     occurs in the blood vessels that lead to your heart, and the purpose of this study is to see     if celecoxib can reduce the blood vessel inflammation associated with high cholesterol and     heart disease.   "
200234|NCT00471354|"     The purpose of the study is to investigate the relationship of changes in measures of     academic performance and problem behaviors, to changes in core     Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with     atomoxetine.   "
200235|NCT00461526|"     Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS)      The purpose of this study is to investigate the safety and effectiveness of a new     investigational drug in women for the treatment of diarrhea-predominant irritable bowel     syndrome. The investigational drug is a natural product taken from a plant that grows in     South America. The study medication will be administered orally twice a day. Subjects will be     not able to remain on certain standard IBS medications (anti-diarrheals) while participating     in the study. The total duration of the study is 18 weeks.      The study requires five study visits that include physical exams, ECG, blood draws,     laboratory studies, and a colon procedure (such as a colonoscopy or flexible sigmoidoscopy if     an appropriate procedure has not been performed in the last 5 years.) Participants will be     asked to make entries into a touch-tone telephone diary on a daily basis.      Participants must meet all of the following criteria:        -  Females at least 18 years of age        -  Diagnosis of diarrhea predominant Irritable Bowel Syndrome        -  Willingness to make daily calls on a touch-tone telephone        -  Willingness to have an endoscopic and/or radiologic bowel evaluation, if you have not          received one in the past 5 years.        -  Willingness to take an approved method of birth control (if required)      Participants CANNOT meet any of the following criteria:        -  Serious medical or surgical conditions        -  Colon Cancer, Crohns Disease or Ulcerative Colitis        -  Pregnant or breast feeding   "
200236|NCT00461539|"     This study will determine the effectiveness of a health education intervention in reducing     health risk behavior and improving health in adolescents with depression.   "
200293|NCT00473590|"     This is a randomized, blinded, placebo-controlled, multicenter, Phase II study designed to     provide a preliminary assessment of the safety and efficacy of combining bevacizumab with     bortezomib in patients with relapsed or refractory multiple myeloma.   "
200237|NCT00461552|"     To determine the efficacy and safety of 4 therapeutic interventions on HAART-Induced     lipodystrophy. The interventions are: 1) Dietary - the effect of a high carbohydrate vs.a     high cis-monounsaturated fatty acid diet. 2) The effect of aerobic exercise with dietary     advice. 3) The effect of Omega-3 Fish Oil Capsules. 4) The effect of leptin therapy. These     interventions are aimed at improving the metabolic complications of HAART therapy such as     elevated lipids, and insulin resistance or diabetes.   "
200238|NCT00461565|"     Vardenafil (Levitra) and Sildenafil (Viagra) are drugs that are marketed for use in patients     with erectile dysfunction. The purpose of this study is to find out if there are any changes     in the eye after taking at least 15 doses of Vardenafil and after two doses of Sildenafil.     This is a double-blind study, which means that neither you nor the study doctor will know     which treatment you are receiving. If you qualify for the study, you will receive:-     Vardenafil 20 mg twice per week (Monday and Thursday) for a maximum of 8 weeks. There will be     two times when this occurs during the study.- Sildenafil 200 mg/day for two days. There will     be two times when this occurs during the study. - Placebo (a pill that looks like vardenafil     or sildenafil but has no active ingredient).   "
200239|NCT00461578|"     In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of     the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with     uncomplicated P. falciparum malaria randomly allocated to AQ+SP or CD+A were followed up     until day 28 after treatment. Adverse events, clinical and parasitological outcomes were     recorded.   "
200240|NCT00461591|"     The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in     randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of     Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.   "
200241|NCT00461604|"     It has been reported that Baclofen is an appropriate tool in the therapeutic management of     Gastroesophageal Reflux Disease. To objectify gastroesophageal reflux combined     pH-metry/impedance monitoring was applied to patients with persistent reflux-associated     symptoms despite PPI-therapy (40mg esomeprazole for 2 weeks). After provement of pathological     findings in the test PPI-dosage was escalated to double standard-dosage for another for     weeks. In case of persistent symptoms another ph-metry/impedance monitoring was performed. In     case of pathological findings additional baclofen was administered to the therapeutic regime.     After 3 months another ph-metry/impedance monitoring was performed. At the time point of the     tests a questionnaire was completed.      Aim of the study was to evaluate the influence of high dosage PPI-therapy and additional     baclofen in patients with persistent symptoms and objectified gastroesophageal reflux.   "
200242|NCT00461617|"     The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to     Nateglinide for the treatment of type 2 diabetes.   "
200243|NCT00461630|"     The primary aim is to assess the effects of raising HDL cholesterol (the good type) with     extended release niacin/laropiprant 2g (previously known as MK−0524A) versus matching placebo     on the risk of heart attack or coronary death, stroke, or the need for arterial bypass     procedures (revascularisation) in people with a history of circulatory problems. The     secondary aim is to assess the effects of extended release niacin/laropiprant 2g daily on     heart attack, coronary death, stroke, and revascularisation separately and to assess the     effects on mortality both overall and in various categories of causes of death, and of the     effects on major cardiovascular events in people with a history of different diseases at the     beginning of the study.   "
200244|NCT00461643|"     Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Even if     several first-step treatments have been proposed for anovulatory infertile PCOS patients,     very few data are available in literature regarding the best integrated strategy. In fact, a     single compound could be effective as first-step approach but not or less useful when     integrated in a more complex strategy.      The goal of the current protocol will be to compare three different strategies for treating     anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy     rate.   "
200245|NCT00461656|"     The purpose of this study is to compare the efficacy of 5 % vs. 1.25 % povidone-iodine (PI)     as preoperative antiseptic prior to strabismus surgery in children as a prophylaxis of     endophthalmitis. Given the low rate of endophthalmitis the conjunctival bacterial flora rate     is used as surrogate marker to determine the effectiveness of topical PI in reducing or     eliminating bacteria from the ocular surface at the time of the surgery. Secondary objective     is a reduction of the incidence of postoperative endophthalmitis after strabismus surgery in     young children.   "
200246|NCT00461669|"     Hip fractures are usually classified according to their X-ray as subcapital, pertrochanteric.     We examine hip fractures with ultrasound in order to characterize the fractures with several     parameters.   "
200247|NCT00461682|"     SB-705498 has demonstrated efficacy in several preclinical and human experimental pain     models. This study will investigate the efficacy of SB-705498 in patients with rectal pain.     This will be a double-blind, placebo-controlled, two-way crossover study. 21 patients with     faecal urgency (Group 1), and 21 patients with IBS (Group 2) will complete this study.   "
200248|NCT00461695|"     Recent studies indicate that persistent viral infections particularly with Cytomegalovirus     (CMV) might have a negative impact on immune senescence (i.e. immunocompetence of elderly     individuals). We will test this hypothesis by performing a vaccination trial in healthy     elderly individuals subdivided in two groups of CMV-seropositive and CMV-seronegative     individuals. All individuals will be vaccinated with the currently licensed vaccine for the     prevention of TBE (FSME Immun CC) which is recommended for the general population in our     area. Vaccination efficacy will be monitored longitudinally concerning the TBEV-specific     antibody (TBEV-neutralization, TBEV-specific ELISA) and T cell response (ELISpot, cytokine     production).      Vaccination efficacy will be compared between CMV+ and CMV- individuals and correlated with     the CMV-specific immune response in CMV+ individuals.   "
200249|NCT00461708|"     This single arm study will evaluate the relationship between the skin toxicity of Tarceva in     combination with gemcitabine, and survival, in patients with advanced and/or metastatic     pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will     be administered 100mg po per day. The anticipated time on study treatment is until disease     progression, and the target sample size is 100-500 individuals.   "
200250|NCT00461721|"     To find a test to elaborate a parameter for specific immunotherapy in allergic patients   "
200251|NCT00461734|"     This study will be done in patients who require the implantation of a cardiac pacemaker (an     electronic device that controls the heartbeat) for complete heart block (a heart rhythm     abnormality resulting in a slow heart beat). Pacemakers regulate the heart beat by delivering     pulses of electricity through special wires (pacing leads) which are placed inside the heart.      This study will compare two groups of pacemaker patients. Each group will have their pacing     leads placed in a particular location in the heart. The purpose of the study is to show     whether the position used in one group is better for maintaining effective heart function     compared to the position used in the other group.      The leads in one group will be placed in a position called the Right Ventricular Apex. This     is the traditional and most frequently used position for pacemaker leads.      The leads in the other group will be placed in a position called the Right Ventricular High     Septum. This is a less commonly used position, but may result in health benefits for the     patients compared with the Right Ventricular Apex.   "
200252|NCT00461747|"     The primary objective is to compare safety and efficacy of three induction treatments:     VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide /     Dexamethasone. The second one is to evaluate the ability of stem cell mobilization after the     treatments in order to do an autologous transplant. Otherwise this study wants to compare the     safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide versus     Thalidomide/Velcade.   "
200253|NCT00461760|"     This is a randomised controlled trial of HPV testing with cytology triage for HPV positive     women compared to liquid-based cervical cytology (LBC). Although LBC is not widely used for     cervical cancer screening in Canada at present, the Pan-Canadian Cervical Cancer Forum has     recommended its use and as it is likely to be the standard of care by the time these data are     published, the trial has been designed to account for this. Further, LBC will improve the     cost-effectiveness of HPV testing because the LBC medium is suitable for both HPV testing as     well as cytology and thereby allows the triage testing to be undertaken from the same sample     without having to recall the women.   "
200254|NCT00461773|"     The purpose of this study is to evaluate the objective response rate of a combination of     letrozole (Femara) and bevacizumab (Avastin) given preoperatively to postmenopausal patients     with hormone sensitive breast cancer.   "
200255|NCT00461786|"     The primary purpose of this trial is to estimate the drug effect on tumors in patients with     ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until     disease progression or unacceptable toxicity. This medication will be given over 10 minutes     and may be administered intravenously (IV), through a vein in your arm. Vitamin     supplementation is a required part of this study.   "
200256|NCT00471367|"     This study has two parts (A and B). The primary purpose of Part A is to find the maximum     tolerated dose is for an experimental drug called AZD4877 based on the side effects     experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an     additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is     an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading     to tumor growth   "
200257|NCT00471380|"     Double blind, crossover randomized, multicentric study to compare efficacy and tolerability     of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed     combination in patients with glaucoma or ocular hypertension   "
200258|NCT00471393|"     The use of a topical medication was compared to placebo to be applied over the symptomatic     temporomandibular joint in women with the diagnosis of osteoarthritis of the     temporomandibular joint(s).      The hypothesis is to investigate whether the use of a topical anti-inflammatory medication     when compared to the placebo would decrease the pain of the affected joint and/or increased     mouth opening.   "
200259|NCT00471406|"     Purpose: To investigate the efficacy of photodynamic therapy with verteporfin for the     treatment of patients with corneal neovascularization.      Design: Prospective, non-comparative case series. Participants: Eighteen eyes of 18 patients     with stable corneal neovascularization who were refractory to conventional treatment.      Methods: The patients were treated with photodynamic therapy with verteporfin (6 mg/m2). Five     patients were treated following penetrating keratoplasty, and 2 patients were treated before     penetrating keratoplasty. Best corrected visual acuity and anterior segment photography were     performed before and after treatment. The length of cumulative blood vessels and area of     corneal neovascularization were measured.      Main outcome measures: Vascular occlusion, best corrected visual acuity, cumulative blood     vessel length, and corneal neovascularization area.   "
200260|NCT00471419|"     The purpose of this study is to see if Rimexolone (FID 109980) is a safe and effective     treatment of dry eye.   "
200261|NCT00471432|"     RATIONALE: OGX-011 may kill tumor cells by blocking some of the proteins that may cause tumor     cells to grow. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving OGX-011 together with docetaxel may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of OGX-011 when given     together with docetaxel in treating patients with metastatic or locally recurrent solid     tumors.   "
200262|NCT00471445|"     RATIONALE: Topical cream containing amitriptyline and ketamine may help relieve pain,     numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether     topical amitriptyline and ketamine cream is more effective than a placebo in treating     peripheral neuropathy caused by chemotherapy.      PURPOSE: This randomized phase III trial is studying the side effects and how well topical     amitriptyline and ketamine cream work compared with a placebo in treating peripheral     neuropathy caused by chemotherapy in patients with cancer.   "
200263|NCT00471458|"     Previous studies of hyperthyroid patients suggest that they remain at increased risk of     cardiovascular morbidity after restoring euthyroidism.      The study objective is to compare the rate and causes of hospitalization of hyperthyroid     patients treated with radioactive iodine (RAI) with those of an age- and gender-matched     reference population in a long-term follow-up study.   "
200290|NCT00473551|"     Primary Objective:      1. To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes,     defined as the dose which achieve engraftment without severe GVHD (graft-vs-host disease) at     90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells.      Secondary Objective:      1. Toxicity, response rate, time to progression and overall survival.   "
200264|NCT00471471|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells. Giving vaccine therapy together with GM-CSF, CpG 7909, and incomplete     Freund's adjuvant may make a stronger immune response and kill more tumor cells.      PURPOSE: This clinical trial is studying the side effects and how well vaccine therapy works     in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by     surgery.   "
200265|NCT00471484|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, doxorubicin, and fluorouracil,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells.     Giving combination chemotherapy together with interferon alfa may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with interferon alfa-2b works in treating patients with nonmetastatic liver cancer that     cannot be removed by surgery.   "
200266|NCT00471497|"     In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg     twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients     with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase     (CML-CP).   "
200267|NCT00471510|"     The purpose of this study is to evaluate the safety and efficacy of three doses of topical     NEOSH101 applied once-daily (qd) for 16 weeks in men with thinning hair in the top and center     of the scalp (Norwood/Hamilton grades III-IV androgenetic alopecia). Four equally sized     treatment groups (35 men each) will receive either NEOSH101 0.5%, NEOSH101 1.0%, NEOSH101     2.0% or placebo. A 12-week observation period will follow the treatment period.   "
200268|NCT00471523|"     Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in     patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound     between them should be initially administered. The aim of the study will be to compare in a     clinical setting the efficacy of CC and metformin as first-line approaches for treating     anovulation in infertile PCOS patients.   "
200269|NCT00471536|"     This phase II trial is studying the side effects and how well pazopanib works in treating     patients with metastatic urothelial cancer. Pazopanib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
200270|NCT00471549|"     Diabetes is associated with dyslipidaemia leading to generalized atherosclerosis,     cardiovascular disease (CVD) and nephropathy. Osteoprotegerin (OPG), a glycoprotein involved     in bone homeostasis, has been implicated in the pathogenesis leading up vessel calcification.     Furthermore, CVD in diabetics is associated with increased levels of OPG.      Aim: To investigate whether low dose simvastatin treatment (10-20 mg/day) reduces circulating     levels of OPG as well as adhesion molecules (VCAM-1; vascular cell adhesion molecule-1, ICAM;     intercellular cell adhesion molecule).   "
200271|NCT00471562|"     RATIONALE: Angiotensin-(1-7) may stop the growth of solid tumors by blocking blood flow to     the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of angiotensin-(1-7)     in treating patients with metastatic or unresectable solid tumors.   "
200272|NCT00471575|"     Non alcoholic fatty liver disease (NAFLD) is one of the main causes of development of chronic     liver disease and cirrhosis. There are no published studies which have investigated the     incidence of NAFLD in pregnant women or the correlation between the metabolic changes in     pregnancy and this phenomenon.      We aimed in our study to explore the incidence of NAFLD in pregnancy by ultrasonography (US)     during the end of the pregnancy or immediately after birth (after 36 weeks) and to look for a     correlation between fatty liver and demographic, clinical, nutritional and laboratory data     during pregnancy.   "
200273|NCT00471588|"     3 groups of subjects (healthy controls, OCD subjects and stimulant-dependent subjects) will     receive pramipexole (1.5 mg, single dose), amisulpride (400 mg, single dose) or placebo in a     cross-over, double-blind, placebo-controlled design.      Effects of compulsive behaviour will be assessed using fMRI and cognitive testing.      Assess biomarkers including cardiovascular responses and plasma levels. All groups studied on     3 separate occasions following screening, with at least a week intervening between     consecutive assessments. The procedures to be adopted for study assessment will be identical     on each occasion.   "
200274|NCT00471601|"     RATIONALE: A questionnaire that evaluates a patient's expectations about breast     reconstruction surgery may help doctors improve patient education before surgery and increase     patient satisfaction after surgery.      PURPOSE: This clinical trial is developing a questionnaire to evaluate patient expectations     for breast reconstruction in women with breast cancer or other conditions.   "
200275|NCT00471614|"     The purpose of this study is to determine whether uridine supplementation will improve     insulin sensitivity and overall carbohydrate metabolism in HIV-positive subjects who are     currently undergoing treatment with antiretroviral regimens containing stavudine or     zidovudine and who have evidence of impaired mitochondrial function and insulin resistance.   "
200276|NCT00471627|"     Previously we have demonstrated in animal experiments,that pancreas is extremely vulnerable     to handling, reacting with the development of pancreatitis. In human pancreatic surgery,     post-operative pancreatitis mediates many other post-operative complications. A new     anastomosis was developed to diminish the injury, as being without any stitches going through     the pancreas. The aims were to study up to 30 patients as phase one study, with an interim     analysis in this open uncontrolled trial after the first few patients.   "
200277|NCT00471640|"     The purpose of this study is to determine whether dexamethasone reduces the length of     hospital stay in patient with a community-acquired pneumonia.   "
200278|NCT00471653|"     RATIONALE: Studying samples of blood in the laboratory from patients receiving temozolomide     may help doctors learn how temozolomide works in the body. It may also help doctors learn     more about how a patient's genes may affect the risk of developing thrombocytopenia.      PURPOSE: This clinical trial is studying the pharmacokinetics in patients with newly     diagnosed high-grade glioma receiving temozolomide and radiation therapy.   "
200291|NCT00473564|"     To evaluate the use of the daVinci Robotic System for better visibility and access of head     and neck lesions and decreased amount of surgery time.   "
200294|NCT00473603|"     The purpose of this study is to determine whether free fatty acids modify the androgen levels     in healthy young women.   "
200279|NCT00471666|"     This study will examine the clinical, immunological and epidemiological effects of concurrent     infections with P. falciparum and W. bancrofti or M. perstans (the parasites that cause     malaria and filariasis) on the frequency and severity of malaria infection in children and     young adults in Mali, Africa.      Residents of Tien gu bougou and Bougoudiana, Mali, who are between 1 and 20 years of age may     be eligible for this study. Participants with and without filarial infection will be     enrolled.      Participants undergo the following tests and procedures:        -  Baseline evaluation with medical history and physical examination, blood tests and stool          culture        -  Brief physical examinations weekly        -  Blood tests monthly for malaria        -  Standard treatment offered for anyone with malaria        -  Blood tests for filarial infection at the beginning, midpoint and end of the          transmission season        -  Treatment for lymphatic filariasis is available through the National Program for the          Elimination of Lymphatic Filariasis. There is no effective standard therapy for M.          perstans.        -  Treatment for other parasitic worm infections, if needed.   "
200280|NCT00471679|"     RATIONALE: Ethanol-lock treatment may help prevent central venous catheter infections in     patients with high-risk neuroblastoma.      PURPOSE: This phase I trial is studying the side effects of ethanol-lock treatment in     preventing central venous catheter infections in patients with high-risk neuroblastoma.   "
200281|NCT00471692|"     Inguinal hernia repair is a common surgical procedure. The major current debates revolve     around laparoscopic hernia repair. The most recent Cochrane review concluded that     laparoscopic inguinal hernia repair was associated with less post operative and chronic pain,     shorter convalescence and earlier return to work when compared to open repair (McCormack K,     Scott NW, Go PM, Ross S, Grant AM. EU hernia trialist collaboration. Laparoscopic techniques     versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev 2003;     1(CD001785.). However, laparoscopic repair has not gained wide acceptance. It is more     expensive, technically difficult for the inexperienced surgeon, is associated with rare but     potentially more hazardous procedure related complications (Lo CH, Trotter D, Grossberg P.     Unusual complications of laparoscopic totally extraperitoneal inguinal hernia repair. ANZ     journal of Surgery 2005 Oct, 75(10): 917 - 919.) and unlike open repair, requires a general     anaesthetic. Critics state that laparoscopic repair is not suitable for all general surgeons     and should be restricted to experts. Two prospective studies have shown that a longer     laparoscopic learning curve exists when compared to open surgery. Up to 200 laparoscopic     procedures are required to achieve a recurrence rate comparable to open mesh repair. (Bittner     R, Schmedt CG, Schwarz J, Kraft K, Leigl BJ. Laparoscopic transperitoneal procedure for     routine repair of groin hernia British journal of Surgery 2002 89; 1062 - 1066.) A     meta-analysis and large multicentre randomised study have added to these concerns by     demonstrating a higher recurrence rate with laparoscopic repair. (Memon MA, Cooper NJ, Memon     B, Memon MI, Abrams KR. Meta-analysis of randomised controlled trials comparing open and     laparoscopic inguinal hernia repair. British journal of Surgery 2003; 90: 1479 - 1492.     Neumayer L, Giobbie-Hurder, Jonasson O, Fitzgibbons R, Dunlop D, Gibbs J et al. Open mesh     versus laparoscopic mesh repair of inguinal hernias. New England Journal of Medicine 2004;     350: 1819 - 1827.). Over the period 1998 to 2003, in Denmark, the frequency of laparoscopic     repair remained constant at 4.5 - 8.0%, the laparoscopic approach being used more frequently     for bilateral hernia repairs and recurrent hernia repairs. There was a higher re-operation     rate following laparoscopic repair of bilateral inguinal hernias compared to bilateral open     hernia repair. (Wara P, Bay-Nielsen M, Juul P, bendix J, Kehlet H. Prospective nationwide     analysis of laparoscopic versus Lichenstein repair of inguinal hernia. British Journal of     Surgery 2005 92(10); 1277 - 1281.)      Given these issues, a considerable number of adult inguinal hernia repairs will continue to     be performed using the open technique. There is the opportunity to improve the results of     open repair by potentially improving post operative pain and chronic pain. One method may be     to perform an ilio inguinal nerve block. However, this procedure can be complicated by     femoral nerve palsy, colonic or small bowel puncture and pelvic haematomas (Johr M, Sossai R.     Colonic puncture during ilioinguinal nerve block in a child. Anesth Analg 1999 88 1051 -     1052, Amory C, mariscal A, Guyot E et al. Is ilioinguinal/iliohypogastric nerve block always     totally safe in children? Paediatr Anaesth 2003; 13: 164 - 166. Vaisman J. Pelvic hematoma     after an ilioinguinal nerve block for orchialgia Anesth Analg 2001 92 1048 - 1049. Notaras     MJ. Transient femoral nerve palsy complicating preoperative ilioinguinal nerve blockade for     inguinal herniorrhaphy. British Journal of Surgery 1995 82: 854. Rosario DJ, Skinner PP,     Raftery AT. Transient femoral nerve palsy complicating preoperative ilioinguinal nerve     blockade for inguinal herniorrhaphy. British journal of Surgery 1994 81: 897. Ghani KR,     McMillan R, Paterson-Brown S. Transient femoral nerve palsy following ilio-inguinal nerve     blockade for day case inguinal hernia repair. J R Coll Surg Edinb 2002; 47: 626 - 629. Erez     I, Buchumensky V, Shenhman Z, et al. Quadriceps paresis in pediatric groin surgery. Pediatr     Surg Int 2002; 18: 157 - 158, Vironen J, Neiminen J, Eklund A, Paavolainen P. Randomised     clinical trial of Lichtenstein patch or prolene hernia system for inguinal hernia repair.     British Journal of Surgery 2006; 93: 33 - 39)), resulting in delayed discharge of patients.     It also has a failure rate of 20 - 30% (Lim SL, Ng SB, Tan GM. Ilioinguinal and     iliohypogastric nerve block revisited; single shot versus double shot technique for hernia     repair in children. Paediatr Anaesth 2002; 12; 255 - 260.) The aim of our study is therefore     to assess the role of ilio inguinal nerve block in adult patients undergoing primary inguinal     hernia repair.   "
200282|NCT00473447|"     The purpose of this study is to determine if a modified protocol of constraint-induced     movement therapy (CIT) is effective in rehabilitation treatment of arm paresis in children     with cerebral palsy. In these children one main problem the non-use of the affected arm. Many     studies showed that the non-use phenomenon can by reversed by the CIT, a rehabilitation     program consisting of 15 days of restraining the unaffected arm plus a daily intensive (6     hours/day) physiotherapy training of the paretic arm. The present study aims at evaluating if     a shortened CIT protocol (restraining device plus only 2 weekly hours of physiotherapy) is     effective in improving use and function of children paretic arm   "
200283|NCT00473460|"     Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine     if this drug, when taken periodically in addition to the patients normal treatment, is     effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately     1132 subjects will participate, and it is expected that the study will run for 2 years in     order to reach that goal. The patients individual involvement in the study will be 17 months.     Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication     (moxifloxacin or placebo) will be taken in addition to the patients normal medication for     chronic bronchitis. In addition to the first clinic visit, called a screening visit, the     patient will be required to come back to the clinic for ten more study visits, every 8 weeks.     At the first visit the study co-ordinator will provide him with the dates for all the visits.     Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will     receive the study medication which he will take for five days, in addition to his normal     treatment for chronic bronchitis. After this time the patient will enter a follow up period     for 24 weeks, where he will come to the clinic for assessments and continue to take his     normal medication but not receive the study drug. A complete medical history will be taken at     the first visit, including the patients past and current smoking habit. A breath test will be     performed to assess how well his lungs are functioning. In addition, he will also be asked to     provide a sputum sample for a microbiological examination to identify any bacteria present in     the sample. The patient must be able to provide a sputum sample at the screening visit. If     the patient meets all the inclusion / exclusion criteria for the study, he will be allocated     randomly to one of the following treatment groups at the second visit.- Treatment group 1:     Receives moxifloxacin orally once daily for five days.- Treatment group 2: Receives a     matching placebo once daily for five days.In between each visit (four weeks after your clinic     visit), the study site co-ordinator will contact the patient to check on his well being. If     the patient or the doctor decides to stop the patients participation in the trial for any     reason, the patient will be required to return to the clinic for a physical examination, take     a breath test, provide a sputum sample (if possible) and have a blood sample taken.   "
200284|NCT00473473|"     ICU-Protocol.Summary Profuse and tenacious tracheal secretions are a significant factor     impeding the weaning process in mechanically ventilated patients in the intensive care unit     (ICU). In homeopathy, high dilutions of plant extracts, minerals, and other biological     substances are used as remedies for the treatment of illness, which is based on the Law of     Similars (the higher the dilution, the stronger the effect). Kali Bichromicum (potassium     dichromate) is a drug that is commonly used in homeopathy, mostly for conditions involving     profuse, stringy, tenacious mucous and tracheal secretions. A recent randomized,     double-blind, placebo-controlled study found a statistically significant effect of this     remedy on improving the amount of tracheal secretion, timing to extubation and discharge from     the ICU among critically ill patients, with no side effects observed.      The proposed study will compare the efficacy of Kali bichromicum 10-60 (C30) versus placebo     in reducing the amount of tracheal secretions in patients intubated with a conventional     endotracheal tube or tracheostomy and receiving controlled mechanical ventilation in the ICU     setting. The quantity of the secretions will be studied, as well as sputum neutrophil count     (using direct microscopy). Time to extubation and the need for re-intubation will also be     evaluated. 56 patients over the age of 18 years treated with mechanical ventilation for at     least 3 days will be recruited from the ICU departments of 4 medical centers in Israel. The     preparations will be administered in the form of small pellet-like globules, which will be     placed on the mucosa of the mouth, to the side of the endotracheal tube. Patients will be     randomly allocated to either verum (n=28) or placebo (n=28) treatment, with the remedies     administered twice daily with an interval of 12 hours, for a period of up to 14 days or until     the patient is extubated. Any adverse event will be recorded.   "
200285|NCT00473486|"     The majority of patients with advanced NSCLC treated with standard platinum based     chemotherapy regimens ultimately develop disease progression. Active therapies with improved     toxicity profiles are clearly needed in this setting. The primary objective of this trial is     to assess the toxicity profile and to determine the effect on progression free survival and     time to progression in patients with advanced NSCLC treated with sorafenib in addition to     carboplatin and pemetrexed.   "
200286|NCT00473499|"     The aim of the PEPCAD III substudy is to assess the efficacy of the Paclitaxel-eluting DEBlue     stent system in the treatment of stenoses in native coronary arteries compared to the     Sirolimus-eluting Cypher stent by intravascular ultrasound (IVUS) and to study the influence     of both devices on endothelial function, coronary flow reserve, and stem cell mobilization.   "
200287|NCT00473512|"     The purpose of this study is to determine the maximum tolerated dose and evaluate the safety,     tolerability, and activity at the recommended dose (maximum tolerated dose [MTD]) of     abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate     (gland that makes fluid that aids movement of sperm) cancer (HRPC).   "
200288|NCT00473525|"     The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of     multiple parallel doses of PF-00734200 following oral administration to adult human subjects     with T2DM who currently are on a stable dose of metformin.   "
200289|NCT00473538|"     Lifestyle modifications are successfully employed in polycystic ovarian syndrome (PCOS)     improving menstrual cycles and fertility. Unfortunately, the compliance over the time is very     low. Recently, we have showed a high adherence to structured exercise training (SET) program     in women with PCOS. The current study will be aimed to compare the efficacy of the SET     program with a diet program on the reproductive function in obese anovulatory infertile PCOS     patients.   "
200923|NCT00465595|"     This research is being done to study the psychological effects of psilocybin in cancer     patients. Psilocybin is a naturally occurring substance found in some mushrooms that some     cultures have used for centuries in religious practices.   "
200295|NCT00473616|"     This is an open-label, multi-center, dose-escalation and safety expansion, Phase I study to     evaluate the safety, tolerability, and pharmacokinectics and to investigate biomarker changes     of AZD7762 administered as a single intravenous unit and in combination with irinotecan. The     study is sponsored by AstraZeneca.   "
200296|NCT00473642|"     In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced     fluence PDT combination therapy with ranibizumab. The researchers hope to gain information     regarding the use of reduced fluence PDT combination therapy. The information gained from     this pilot study may prompt further definitive studies comparing the safety and efficacy of     both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and     ranibizumab monotherapy.      The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to     ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All     patients will receive three consecutive monthly treatments with ranibizumab. Patients will be     randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab.     Patients randomized to group 2 will also receive one treatment with reduced fluence (50%     fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one     treatment with standard fluence verteporfin PDT. All patients will also be evaluated for     possible retreatment with ranibizumab and verteporfin PDT according to established criteria.     Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time     of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.   "
200297|NCT00473655|"     The primary purpose of this trial is to determine if the treatment with rosuvastatin 10 and     20mg/day during 8 weeks in hypertriglyceridemic patients will reduce their triglyceride     levels.   "
200298|NCT00473668|"     The purpose of this observer-blind study is to generate immunogenicity data with one     formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and     to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK     Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response.     Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib     vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act,     Sep 2007.   "
200299|NCT00473681|"     The primary objective of the proposed clinical trials is to compare the differential     reduction in blood pressure in underserved hypertensive adult Korean American. The study is     designed to test the effectiveness of a comprehensive self-help intervention program.   "
200300|NCT00473694|"     The purpose of the trial is to demonstrate a faster recovery from neuromuscular block with     rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by     70 μg/kg of neostigmine   "
200301|NCT00473707|"     The purpose of this study is to determine if giving oxytocin immediately after delivery     causes less bleeding, transfusion needs and hastens delivery of placenta.   "
200302|NCT00473720|"     This is a phase I dose escalating study of oral satraplatin in combination with Abraxane     administered weekly for three out of every four weeks in patients with advanced solid     cancers.   "
200303|NCT00473733|"     Glucagon like peptides receptors expression in the stomach of diabetes type 2 Glucagon like     peptides (GLP-1, GLP-2), are hormones secreted by L cells located along the gastrointestinal     tract. These hormones are secreted after meals and have some roles in regulating the     digestion process, absorption, and sending signals to the brain that regulate food     consumption. GLP peptides affect peripheral targets and have an important homeostatic role.     GLP-1 decreases the circulatory glucose level and GLP-2 has trophic effects which enable     adequate intestine growth.      We aimed in our study to investigate the GLP-1 and GLP-2 receptor expression in different     zones of the stomach in diabetes type 2 patients. If there are differences, it might explain     the pathological gastric emptying in these patients.      Understanding the function of these peptides may lead to new therapeutic options for diabetic     patients with delayed gastric emptying.      Methods: 20 diabetes type 2 patients with symptoms that need upper endoscopy will be included     in the study and 20 controls aged 18-70 years. Patients with neurological disease will be     excluded. During esophagogastroduodenoscopy 3 biopsies will be taken from the antrum, corpus     and cardia. The biopsies will be stored in -70. After RNA extraction the GLP receptors     expression will established by real time PCR method. Patients with different expression     compared to control will undergo isotopic scan for gastric emptying.   "
200304|NCT00473746|"     The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and     anti‑tumor activities of abiraterone acetate (also referred to as CB7630) in patients with     hormone refractory prostate cancer (HRPC).   "
200305|NCT00473772|"     The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent     Please S stent system (DEBlue) in the treatment of stenoses in native coronary arteries with     nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and < 24 mm in length for procedural     success and preservation of vessel patency in comparison to the Sirolimus-eluting CypherTM     stent.   "
200306|NCT00473785|"     The purpose of this study is to provide lifestyle counselling for protective health behavior     (exercise, diet, smoking cessation) to small groups (6-8 subjects) via teleconference. The     sample includes individuals at elevated risk for cardiovascular disease (CVD) as well as     individuals with established CVD. Our hypothesis is that telephone-based lifestyle     counselling will (1) significantly increase protective lifestyle behavior (diet, exercise,     smoke-free living) and (2) significantly reduce CVD risk factors at 6-month follow-up.   "
200319|NCT00473954|"     Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the     body's cells. When genes are damaged, the body may be unable to produce a group of proteins,     called cytokines, used by the immune system to fight cancer and some infections. The     investigational gene transfer agent EGEN-001 contains the human gene for the cytokine     interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the     body to produce cytokines. Therefore, the purpose of the EGEN-001 therapy is to attempt to     enhance the body's natural ability to recognize and fight cancer cells. Funding Source - FDA     OOPD   "
200395|NCT00474968|"     A clinical study to determine the adequacy and efficacy of the InPath e2TM Collector compared     to the FDA-approved spatula/cytobrush when used as the cell collection device in screening     for cervical cancer.      The InPath e2TM Collector name has been changed to the CytoCore SoftPAP(R) Collector   "
200307|NCT00473798|"     Primary Objectives:        1. To compare levels of patient anxiety, pain, and satisfaction associated with optical          spectroscopy procedures and MDC with the levels associated with colposcopically-directed          biopsy in the cervical cancer diagnostic setting and with Papanicolaou smear in the          screening setting. This aim will be addressed in Studies A and A' -- Procedure-Related          Distress and Patient Satisfaction.        2. To evaluate differences in psychological distress, satisfaction, and adherence to          treatment in the two arms of a randomized trial; one group will be diagnosed with usual          care procedures (Papanicolaou smear and colposcopically-directed biopsy) plus optical          spectroscopy and the second will receive usual care. Aim 2 will be accomplished in Study          B -- Psychological Distress, Satisfaction, and Adherence Outcomes in a Randomized Trial          of Optical Spectroscopy.        3. To assess the psychosocial and behavioral impact of a false positive screening result.          This will be done in Study C -- Impact of False Positive Screening Test on Psychological          Distress and Future Screening Intentions.        4. To assess provider receptivity to optical spectroscopy. Aim 4 will be accomplished in          Study D -- Survey of Health Care Providers.   "
200308|NCT00473811|"     By improving glycemic control, many of the devastating complications of diabetes are to a     large extent preventable. The use of a low GI (glycemic index) diet to improve glycemic     control is relatively new and untested. However, a low GI diet may be a cost-effective     approach to preventing diabetes-related complications. The aim of this proposed 2-year study     is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI     intervention, to reduce dietary GI in patients with type 2 diabetes, and to compare it with a     nutritionist-delivered standard American Diabetes Association (ADA) diet intervention. Our     outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood     lipids, blood pressure, and body mass index), dietary GI scores and acceptability of the     intervention.      Primary hypotheses:      1. Recruitment and retention rates for the low GI intervention will be satisfactory.      Secondary hypotheses:        1. Participants in the low GI intervention group will show more favorable changes in          physiological measures than participants in the ADA diet group.        2. Participants in the low GI group will be successful in lowering the GI of their diet.        3. Participants will find the intervention acceptable.   "
200309|NCT00473824|"     A Phase 2 study to evaluate safety, pharmacokinetics and efficacy of Hepatitis C Immune     Globulin Intravenous (human) [Civacir(TM)] for preventing or reducing the impact of recurrent     HCV infection following liver transplantation.   "
200310|NCT00473837|"     The pathogenesis of post-malaria anaemia is multifactorial. Iron supplementation remains the     mainstay of management of moderate and severe anaemia; however the management of mild anaemia     (Hb 80-110g/l) is problematic as population supplementation studies of children in malaria     endemic areas demonstrate adverse effects in children with mild anaemia. We hypothesize that     the anti-inflammatory, anti-malarial and anti-macrophageal iron loading effects of     chloroquine could make it a useful drug in the management of mild post malaria anaemia. To     test this hypothesis, we plan to randomize children (aged 12 months to 6 years) with post     malaria anaemia (Hb 70-110g/l) to receive a standard anti-malarial treatment, co-artemether .     All children with parasitologic cure after three days on treatment will be randomised to     receive either weekly chloroquine or weekly placebo starting from day 10 till day 90. By     comparing the curve of haemoglobin change between day 3 and day 30 in the placebo arms of the     two groups, we will test the effect of chloroquine vs. ACT treatment on macrophageal iron     loading and release in acute clinical malaria. By comparing the haemoglobin change between     day 3 and day 90 between the weekly chloroquine arms and the weekly placebo arms we will test     the longer-term anti-inflammatory and anti- malarial effects of weekly chloroquine     prophylaxis. In addition to the primary endpoint, we plan to assess potential mechanisms of     action by determining parasite clearance, peripheral cytokine production and iron flux   "
200311|NCT00473850|"     The purpose of this study is to establish the genetic profile of families in British Columbia     with HME.   "
200312|NCT00473863|"     The purpose of this study is to determine whether Coronary Computed Tomographic Angiography     (CCTA) will increase patient safety by decreasing the rate of missed ACS and adverse events     in patients who receive standard care plus CCTA versus standard care alone. Additional goals     of the study are to determine whether CCTA can safely reduce the duration of ED visits and     the number and duration of hospital admissions.   "
200313|NCT00473876|"     Will metformin improve exercise capacity in chronic heart failure patients who has insulin     resistance (pre-diabetic- means before they become diabetic)?   "
200314|NCT00473889|"     This Phase III clinical trial which incorporates an initial Phase II component will determine     the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and     paclitaxel plus carboplatin   "
200315|NCT00473902|"     We examined whether creatine monohydrate (CrM) and conjugated linoleic acid (CLA) could     enhance strength gains and improve body composition (i.e., increase fat-free mass (FFM);     decrease body fat) following resistance exercise training in older adults (> 65 y). Our study     hypothesized that administering CrM and CLA would yield greater strength and body composition     benefits than the placebo group over the six months of resistance exercise   "
200316|NCT00473915|"     Eye symptoms of tearing, redness and itch frequently occur in patients with allergic rhinitis     or hayfever. The purpose of this study is to learn whether placing allergen (the substance     that causes allergies) in the nose several days in a row will cause an increase in eye     symptoms and whether receiving a nasal steroid spray will prevent these eye symptoms.   "
200317|NCT00473928|"     The objective of this study is to provide initial safety and tolerability information of     intravitreal POT-4 for treatment of patients with AMD   "
200318|NCT00473941|"     The purpose of the study is to find new ways to improve the quality of life of people who     have been treated for colon or rectal cancer.   "
200320|NCT00473967|"     Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life     cycle. Vaccination with recombinant ASP-2 has protected dogs and hamsters from infection in     challenge studies. In a clinical study in hookworm-uninfected adults in the USA, Na-ASP-2     Hookworm Vaccine was safe and immunogenic. This study will evaluate its safety and     immunogenicity in individuals living in an area of endemic hookworm infection.   "
200321|NCT00473980|"     The study is designed to evaluate effects of NSAIDs on immune activity inside and close to     tumor tissue in patients with colorectal cancer.   "
200322|NCT00473993|"     Hepatitis C viral infection is common among opioid addicts in Zurich, Switzerland. The     majority undergoes a maintenance treatment with methadone, heroin or buprenorphine. While     stabilized by an opioid maintenance treatment (OMT)chronic hepatitis C can be treated with     pegylated interferon plus ribavirin. As not sufficiently known, the results are comparable to     the results of the treatment of nonaddicts.      Our crossectional study investigates how many patients undergoing OMT are adequately     investigated concerning hepatitis C. If not, why are they not adequately investigated and     treated? Representative data are collected in the local clinics and medical practices     involved in OMT in the Kanton of Zurich. The patients files are revised and the involved     doctors are asked through a structured interview.   "
200323|NCT00474006|"     Determine the effects of escalated dose of daunorubicin in induction treatment of adult     patients with acute myelogenous leukemia who are younger than 60 years of age.   "
200324|NCT00474019|"     The purpose of this research study is to evaluate how much of repeated once daily intravenous     (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized     children aged 0-17 years old that require acid suppression therapy.   "
200325|NCT00474032|"     The purpose of this study is to determine the effectiveness of treatment of idiopathic     clubfoot utilizing Botulinum Toxin Type A (Botox). This is not a hypothesis-generating study     as we are reporting on outcomes of patients who have been treated by this method of clubfoot     treatment.   "
200326|NCT00474045|"     This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of     this trial is to compare the effect and safety on blood glucose control in pregnant women     with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH     insulin) given as long-acting insulin in combination with a short-acting insulin (insulin     aspart).   "
200327|NCT00474058|"     The objective of this trial is to assess the effects of transdermal rotigotine on the control     of early morning motor function and sleep disorders compared to placebo in subjects with     idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and     non-motor symptoms of Parkinson´s disease will be evaluated.   "
200328|NCT00474071|"     The routine medications to relax the muscles of the throat are an anesthetic drug, propofol,     in combination with an ultra short acting pain medicine, remifentanil. Remifentanil is used     to reduce the amount of propofol required but also to decrease the natural cough reflex to     the breathing tube being inserted.The purpose of this study is to find the dose of     remifentanil when combined with propofol which provides the best conditions for intubation     without cough in infants and small children.Younger children may need higher doses of     Remifentanil to facilitate intubation as they are more tolerant to the respiratory depressant     effect of Remifentanil.   "
200329|NCT00474084|"     The purpose of this first feasibility study is to evaluate the performance of Vesta™ &     VestaCOR™ (Hydroxy-Apetite coated GenX) stent in de novo native coronary artery lesions. This     study will provide the longest follow-up experience available.      This is a randomized, double blind study conducted at three sites, two sites in India and one     in The Netherlands. To be eligible, a patient will be required to have a de novo stenotic     lesion of a length that could be covered by a single stent in a native coronary artery of     diameter 3.0mm and 3.5mm. A total of at least 60 patients and a maximum of 70 patients will     be treated with Vesta™ & VestaCOR™ stent. These patients will be randomized to either a     smooth surface nanofilm coated stent (= VestaCOR™) (approx. 35 patients) or to a porous     coated stent (= Vesta™) (approx. 35 patients).      All patients will be followed clinically at 30 days, 4 months, 9 months, 1, 2, 3, 4 and 5     years.   "
200330|NCT00474097|"     The purpose of this study is to assess if follow-up telephone calls after colorectal surgery     affects a patient's satisfaction, the outcome of their surgery, and their quality of life. In     addition, readmissions, complications and emergency room visits can be tracked via these     telephone calls, ensuring optimal communication between patients and the surgical office.   "
200331|NCT00474110|"     The treatment of cancer in children may result in an extremely painful condition called oral     mucositis when the cells lining the mouth are injured due to the cancer medication. Patients     with this condition are often unable to take anything by mouth or to swallow their own     saliva. This severe pain may last for as long as 2 weeks. A survey of our previous 22     patients showed high daily pain scores despite the use of intravenous (given through a small     tube in a vein) opioid medications (family of pain relieving drugs, e.g. morphine and     hydromorphone).      The purpose of this pilot study is to determine which of 3 concentrations of ketamine to     combine with hydromorphone to provide the best pain relief with minimum side effects. The     results from this study will allow us to do a larger study to compare the best concentration     found from this study to standard treatment. If successful, this combination of ketamine and     hydromorphone will also be used to treat other pain problems in children.   "
200332|NCT00474123|"     Among patients with stable coronary artery disease (CAD), it is not clear if the pleiotropic     effects of cholesterol reduction differ between high-dose simvastatin alone and combined     ezetimibe/simvastatin.      The investigators sought to compare the anti-inflammatory and anti-platelet effects of     ezetimibe 10 mg / simvastatin 20 mg (E10/S20) to simvastatin 80 mg (S80).   "
200333|NCT00474136|"     The purpose of this study is to assess the pharmacokinetic parameters of intravenous     diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose     administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved     reference product.   "
200347|NCT00474331|"     The investigator's goal for this project is to examine the causes of the wide variability of     the expression of Hereditary Multiple Exostoses (HME). Previous work completed by our group     shows that there exists a correlation between genotype and phenotype such that certain     mutations or affected genes cause certain patterns of presentation, symptoms, and signs. The     investigators intend to achieve this goal by increasing our study sample size to build upon     the results generated from the pilot project of this study, in order to obtain statistical     significance. This will be achieved by performing genotype-phenotype analysis on new families     presenting with HME in British Columbia.   "
200429|NCT00475410|"     Anal fistula is defined as an abnormal communication between the anal canal and the perianal     skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas. This     study will test the safety and efficacy of ASCs (adipose stem cells) in the treatment of     patients without Crohn´s disease.   "
200334|NCT00474162|"     Pregnant women are more likely to form clots than non-pregnant women as pregnancy increases     the clotting factors present in the blood. This helps to prevent excess bleeding (hemorrhage)     at the time of delivery. Hemorrhage occurs in 5-15% of pregnancies throughout the world, even     when delivery is by cesarean section. When hemorrhage occurs the anesthesiologist will     normally administer fluids into the woman's vein (intravenously) rapidly to replace the blood     that the woman has lost. Two types of fluids are commonly used. One is a salt water solution     (saline) and the other is a starch water solution (pentastarch). Use of either or both of     these solutions is common during hemorrhage.      These same solutions (salt water solution and starch solution) are used at BC Women's     Hospital during spinal anesthesia to prevent and treat low blood pressure (a common side     effect of spinal anesthesia). This is standard practice whether you are in this study or not.     You may also be given, depending on the anesthesiologist's preference, a drug (vasopressor)     that causes the blood vessels to become narrow (constrict) to prevent or treat the low blood     pressure. Whether you agree to be part of the study or not, your anesthesiologist will be     watching your blood pressure closely throughout your operation and if your blood pressure     becomes low he/she will treat it as is normally done.      Low blood pressure will also occur during hemorrhage. It is therefore important that we     determine whether the starch solution, which is more effective than the salt solution in     preventing low blood pressure during spinal anesthesia, does or does not affect clotting.      Research in non-pregnant adults (male and female) has found that laboratory tests of blood     clotting change with these solutions. For saline the evidence in some studies suggests that     the blood may clot better than normal while other studies suggest the opposite (does not clot     as well). In pregnant and non-pregnant adults the blood does not clot as well with certain     starch solutions. The starch solution used at BC Women's Hospital is called pentastarch and     no research has looked at its effect on clotting in pregnant women. In non-pregnant adults     pentastarch has less effect on clotting than other starch solutions.      The purpose of the study is to see how pentastarch (starch solution) and normal saline (water     with salt in it) given at the time of spinal anesthesia for elective cesarean section affect     the ability of pregnant woman's blood to clot.   "
200335|NCT00474175|"     To evaluate the efficacy and safety of benzocaine gel products for the relief of toothache     and to assess the subject's compliance with proposed label directions.   "
200336|NCT00474188|"     To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with     dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.   "
200337|NCT00474201|"     This study will determine whether the protease inhibitor lopinavir/ ritonavir (Kaletra     (Trademark)), which is used to treat HIV disease, lowers blood levels of the lipid-regulating     drug gemfibrozil (Lopid (Trademark)) in HIV-negative healthy volunteers. Many patients with     HIV infection who take protease inhibitors have abnormally high lipids (cholesterol and     triglycerides). Gemfibrozil, commonly used to treat high triglycerides, often is not     effective in HIV-infected patients taking protease inhibitors, possibly because of an     interaction between the two medicines that causes a lowering of gemfibrozil's levels in the     blood. Results from this study will give researchers information on whether lopinavir/     ritonavir affects the blood levels of gemfibrozil.      Healthy, normal volunteers between 18 and 65 years old who test negative for HIV may be     eligible for this study.      On study day 1, subjects have a blood sample drawn from a catheter inserted into a vein in     the arm to determine pre-dosing blood levels of gemfibrozil. They then take a gemfibrozil     tablet and are given breakfast 30 minutes after taking the drug. Blood samples are obtained     through the catheter at 0, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after dosing to determine     gemfibrozil levels at those intervals. At the end of 12 hours, the catheter is removed and     the subject is discharged from the clinic. The next morning subjects return to the clinic for     another blood sample, collected through a vein in the arm.      Subjects begin taking lopinavir/ ritonavir between 7 and 35 days after their first dose,     depending on their schedule and the clinic schedule. On the fourteenth day of dosing subjects     come to the clinic and are given a single dose of gemfibrozil, as on study day 1, and have     breakfast 30 minutes later. Blood samples are collected to determine gemfibrozil levels just     like on study days 1 and 2. An additional sample is collected for routine lab tests.   "
200338|NCT00474214|"     The purpose of this study is to determine if early hospital discharge (at 48-72 hours), is     feasible, safe, cost-effective, and/or improves compliance with medications, positive     lifestyle changes and quality-of-life, in low-risk patients with ST-elevation myocardial     infarction treated with primary percutaneous coronary intervention (primary PCI).   "
200339|NCT00474227|"     Based on previous findings that mentally ill inpatients are interested in losing treatment     associate weight gain and are capable of adhering to a weight reduction program, this study     will investigate the effects of participation in nutrition intervention, physical exercise     and will monitor measurement of metabolic profiles (cholesterol, triglycerides and glucose).     Hypothesis: participants will reduce weight, maintain weight loss and experience reduction in     metabolic values and will experience improved quality of life.   "
200340|NCT00474240|"     The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and     in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with     moderately high cholesterol.   "
200341|NCT00474253|"     The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced     by 1.2 mg/kg Zemuron® after reversal at 3 minutes by 16.0 mg/kg of Org 25969 compared with     recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.   "
200342|NCT00474266|"     The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority     of the meningococcal vaccine 134612 given with Priorix-Tetra™.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
200343|NCT00474279|"     The purpose of this study is to determine whether treatment of healthy older men and women     with oral MK-677 for 12 months will enhance pulsatile GH release and increase mean GH and     IGF-I concentrations into the range of young adults and will have favorable effects on body     composition and functional ability on older adults.   "
200344|NCT00474292|"     This study will examine how the brain rewires itself to make up for the lack of movement many     people with stroke experience. It will try to determine if the rewiring differs depending on     the location of the stroke and the amount of time since the stroke occurred. For some stoke     patients, weakness may persist, while others recover completely after time. It is not known     which parts of the brain are involved in the recovery of different types of stroke and if the     type of stroke affects recovery.      People 18 years of age and older who have had subacute thromboembolic or hemorrhagic stroke     more than 3 months before enrolling may participate in this study.      Participants come to the NIH Clinical Center three times every 2 years for up to 10 years. At     the first visit, patients have a neurological examination and perform tests of motor     abilities such as lifting small objects, turning cards, using a spoon, stacking checkers and     lifting cans during a short period of time as rapidly as possible.      At the second visit, subjects have structural magnetic resonance imaging (MRI) scans of the     brain. MRI uses a strong magnetic field and radio waves to obtain images of body organs and     tissues. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During     the scan, the subject lies on a table that can slide in and out of the cylinder, wearing     earplugs to muffle loud knocking noises associated with the scanning process. Total scan time     is about 30 minutes      At the third visit, subjects perform some simple movement tasks during functional MRI (fMRI)     scans. The procedure is the same as with structural MRI, except that subjects are asked to     perform simple movement tasks in the scanner. Before the fMRI scans, electrodes are attached     to the subject's arms and legs to monitor muscle activity (surface electromyography). Total     scan time is about 1.5 hours. Movement tasks might include pinching a force-measuring     instrument with the fingers, pressing different keys on a keyboard as fast as possible,     inserting pegs into small holes on a board, lifting weights, flipping cards or similar     activities.   "
200345|NCT00474305|"     This study will examine whether the use of a Virtual World will be effective in helping treat     Posttraumatic Stress Disorder (PTSD). This is a pilot study, with five victims of bus     bombings who have developed PTSD. The study will examine pre- and post-treatment levels of     PTSD, anxiety, depression and day-to-day functioning.   "
200346|NCT00474318|"     The five Teen-LABS clinical centers use standardized techniques to assess the short and     longer-term safety and efficacy of bariatric surgery in adolescents compared to adults.   "
200936|NCT00465764|"     To compare the tolerance and early bone status of healthy, term infants fed formulas during     the first three months of life.   "
200348|NCT00474344|"     The goal of this study is to identify and characterize the genetic loci causing idiopathic     talipes equinovarus (clubfoot).      The hypothesis is that a few genes account for a substantial fraction of ITEV and that these     genes can be identified in defined populations. Towards this goal, in preliminary studies,     Dr. Hecht's group has identified two genes, NAT2 and CASP10, which demonstrate evidence for     linkage and association to ITEV.   "
200349|NCT00474357|"     This study will examine:      1) The impact of psycho education group therapy sessions relating to beliefs/myths associated     with bipolar affective disorder (BAD) on the emotional wellbeing, clinical course and     cognition of individuals diagnosed with BAD 2) Will examine the existence of those same     beliefs among the various caregivers - psychiatrists, general practitioners, social workers,     and psychiatric nurses.      The investigators hypothesize that psychoeducation group therapy will be effective in     refuting the myths and will lead to better treatment adherence, longer remissions, fewer     hospitalizations, improved self esteem, increased optimism, and better control over the     disease process. The investigators also believe that they will identify some beliefs/myths or     preconceived notions that are common to both caregivers and individuals with BAD.   "
200350|NCT00474370|"     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells     that fight infection). Previous smaller studies in HIV treatment-experienced patients, have     shown that vicriviroc is safe and effective. The purpose of this study is to confirm the     previous findings in a larger phase 3 study over a 48-week period, and show that when taken     in combination with other appropriate HIV drugs, vicriviroc can decrease the level of HIV     (viral load) in the blood and that it is well tolerated.   "
200351|NCT00474383|"     The purpose of this study is to assess the anti-tumor activities and safety of abiraterone     acetate in participants with prostate cancer (a disease in which cells in the prostate gland     [a gland in the male reproductive system found below the bladder and in front of the rectum]     become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane     (docetaxel)-based chemotherapy.   "
200352|NCT00474396|"     The purpose of the study is to determine whether low fat dairy diet reduces serum uric acid     levels.   "
200353|NCT00474409|"     The purpose of this study is to determine the efficacy and safety of Betahistine Mesilate in     the treatment of patients with vertigo caused by Cerebral Infarction in posterior     circulation.   "
200354|NCT00474422|"     Hypothesis: We hypothesized that providing in-hospital, supervised paraprofessional     breastfeeding consultation during the hiatus between hospital discharge and the first     postpartum WIC or pediatric visit would increase the rate of exclusive breastfeeding among     low income Hispanic women at 1 month postpartum.   "
200355|NCT00474435|"     In this pilot study the pharmacokinetics and safety of the antiretroviral combination of     co-formulated emtricitabine/tenofovir/efavirenz will be studied in HIV-positive patients with     pulmonary tuberculosis (TB) who are concomitantly treated with a standard rifampin-containing     tuberculostatic regimen. It is expected that this antiretroviral combination causes minimal     drug interactions with the rifampin-containing anti-tuberculosis medication.   "
200356|NCT00474448|"     The purpose of this study is to assess the health-related quality of life of subjects who     have Hereditary Multiple Exostoses and to develop a disease specific quality of life survey.     The investigators hypothesize that there are a wide range of quality of life experiences for     patients with this syndrome.   "
200357|NCT00474461|"     The purpose of this study is to investigate the safety of intracoronary cardiac stem cells     (CSCs) therapy in humans. Currently, there is no effective intervention to regenerate     (regrow) dead heart muscle after a heart attack.      The central hypothesis is that CSCs infused into nonviable myocardial segments will     regenerate infarcted myocardium by differentiating into cardiomyocytes and other cell types.     According to our hypothesis, CSC infusion regenerates myocardium with consequent improvement     in contractile function of the heart and general clinical status.   "
200358|NCT00474474|"     There is a lack of evidence of the impact of the information provided in the introduction     screen on the students diagnostic and therapeutic decisions. The reasoning pattern may also     be altered if positive findings are provided to the student without an active request for it.      The results will be of importance when virtual patients are used for assessing students.   "
200359|NCT00474487|"     This study will evaluate the safety and immune response of Novartis Meningococcal ACWY     conjugate vaccine in healthy adolescents and adults.   "
200360|NCT00474500|"     The aim of this project is to measure the effect of Coca-Cola and Diet Coke, relative to     mineral water, on non-haem iron absorption. The results from this study will quantify any     enhancing effect of Coca-Cola or Diet Coke on non-haem iron absorption and will be of use to     the Coca-Cola Company and the scientific and nutrition community in evaluating the     nutritional value of these products.   "
200361|NCT00474513|"     GSK239512 is being developed for the treatment of symptoms of cognitive impairment in many     diseases. GSK239512 is a drug that binds to the Histamine 3 receptor (a protein) in the brain     (receptor occupancy). This study will use the technique of positron emission tomography (PET)     as an imaging tool to highlight areas of the brain that GSK239512 has penetrated, and     subsequently bound to receptors, after receiving an oral dose of the drug. It will also look     at the rate the drug dissociates from the receptors in the brain. Results from the study will     provide information on doses of the drug to be given in further studies.   "
200362|NCT00474526|"     This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY     conjugate vaccine when administered with routine infant vaccinations to healthy infants.   "
200363|NCT00474539|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of a     13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given     concomitantly with routine paediatric vaccinations in Spain.   "
200364|NCT00474552|"     Primary: To assess the safety and tolerability of ascending multiple oral doses of SAM-315,     an investigational drug, in healthy young adult and elderly subjects.      Secondary: To assess the Pharmacokinetic and Pharmacodynamic profiles of multiple oral doses     of SAM-315 in healthy young adult and elderly subjects.   "
200365|NCT00474565|"     The present study relates to a new approach to coronary artery and coronary artery by-pass     graft imaging, and more particularly to computed tomographic angiography following an aortic     root injection of a low amount of contrast (up to 30 cc) via a percutaneously placed catheter     (Vanguard DX, Medrad Inc.) positioned in the aortic root.      The objective of the study is to show the feasibility of Coronary artery CTA using aortic     root injection of contrast compared to the standard invasive cardiac catheterization.   "
200366|NCT00474591|"     (i) Main Research Question(s): What is the effect of fondaparinux on coronary graft patency,     heart attack, stroke, and death in patients who have undergone coronary artery bypass     grafting (CABG)? To reliably answer this question requires a large randomised trial. We     propose a pilot study to demonstrate the feasibility of recruiting patients into this study     and of performing CT angiograms to measure graft patency at 30 days.      (ii) Why is this research important? Coronary artery bypass surgery has made a very important     contribution to improving the health and survival of patients with advanced coronary artery     disease but still has many problems. One in 10 patients experiences a heart attack at the     time of surgery, 1 in 20 experiences a heart attack, stroke, or death during hospitalization,     and 1 in 4 patients has at least 1 blocked graft within 1 year of surgery. Fondaparinux, a     relatively new anticoagulant drug, has been shown to significantly reduce cardiovascular     events and death in patients who have suffered a recent heart attack. Compared to established     anticoagulant therapies for acute myocardial infarction, fondaparinux has been shown to be     more effective with similar or lower risks of bleeding.      Fondaparinux, unlike the most commonly used anticoagulants, does not cause Heparin Induced     Thrombocytopenia (HIT), a rare condition with extremely high morbidity and mortality.      This drug has never been studied in CABG patients. Our pilot study will provide key     information about feasibility that will help us to design and perform a large definitive     study in the future.      (iii) What is being studied? We will be looking at blood flow in bypass grafts, heart attack,     stroke, venous thromboembolism and death. For safety we will be looking at bleeding,     transfusion, and need for further surgery because of bleeding. We will also perform     laboratory tests for HIT antibodies as their levels are prognostic for the development of HIT     and are also related to morbidity and mortality. The incidence of actual HIT cases will also     be recorded.   "
200367|NCT00474604|"     RATIONALE: Diagnostic procedures, such as MRI, may help diagnose breast cancer. It may also     help doctors predict a patient's response to treatment.      PURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast     cancer and in healthy participants.   "
200368|NCT00474617|"     The purpose of the trial is to compare the effectiveness, safety and pharmacokinetics of Org     25969 in subjects 65 and over with subjects under 65.   "
200369|NCT00474630|"     The purpose of this study is determine whether the combination of naltrexone SR and bupropion     SR is safe and effective in treating obesity in subjects with type 2 diabetes.   "
200370|NCT00474643|"     Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset obesity     and endocrine dysfunction that leads to cardiovascular disability and early death within the     first 3 decades of life.To assess the significance of risk factors for future disabilities,     carotid artery intima-media thickness (IMT) was measured and correlated with known     atherosclerotic risk factors in 27 children with PWS and 24 age-, sex-, and body mass index     (BMI)-adjusted controls.   "
200371|NCT00474656|"     Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of     critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS     kills 40-70% of affected patients. Patients with ARDS require life support in the form of a     ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause     further damage to the lungs. We are conducting a study comparing 2 methods to protect the     lungs from further damage. One method uses standard mechanical ventilators and the other uses     a new type of ventilator, called a high frequency oscillator. We propose to test whether this     high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from     12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study     to test the feasibility of our study methods. If feasible, we plan to move on and conduct a     large multinational study to definitively answer this question.   "
200372|NCT00474669|"     The primary objective is to assess the maximum tolerated dose of docetaxel administered     intraperitoneally with heat at the time of second-look surgery in patients with stage II/III     ovarian carcinoma.   "
200373|NCT00474682|"     The aim of this study is to find out how well iron is absorbed when a newly developed form of     ferric pyrophosphate is added to a commercial apple juice drink.   "
200374|NCT00474695|"     The purpose of the study is to investigate whether the efficacy of Lucentis treatment for     exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA     polymorphisms   "
200375|NCT00474708|"     This study is an open-label, randomized, multi-center study conducted in a typical     psychiatric outpatient practice in China. This study is intended to collect data on the     efficacy and safety of venlafaxine XR (Efexor XR®) versus SSRIs and conventional     antidepressants in depressed patients that previously failed antidepressant treatment. This     data will be used to guide psychiatrists on recommendations for clinic use.   "
200376|NCT00474721|"     We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages     5-18 years who came to the Pediatric Emergency Department with injuries to their arms or     legs.   "
200377|NCT00474734|"     To diagnose hepatocellular carcinoma (HCC) and to determine the extent of the disease, a     triphasic CT scan or a magnetic resonance imaging are required. The characterization of     hepatic nodules is more difficult when the HCC lesions have a diameter of less than 2 cm.      Since accuracy in the assessment of the number and the size of HCC nodules, as well as of the     invasion of blood vessels is crucial to determine outcome after liver transplantation due to     tumour recurrence, there is a need for techniques with a higher definition potential.      As a consequence, to improve outcome and to optimize organ allocation, patients on the liver     transplantation waiting list might benefit from intravascular ultrasound as an additional     examination to complete the pre-transplant tumour staging process.   "
200378|NCT00474747|"     The goal of this clinical research study is to find out the best dose of cyclophosphamide     that can be given with fludarabine, antithymocyte globulin (ATG), and low-dose total body     irradiation (TBI) to patients before a bone marrow transplant to decrease the risks related     to the transplant while not decreasing the effectiveness of the transplant from an unrelated     donor.   "
200379|NCT00474760|"     This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently     enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET     and Askin's).   "
200937|NCT00465777|"     The study intend to evaluate whether the use of standardised malaria case management protocol     plus financial incentives added to the availability of free drugs reduce the case-fatality at     the paediatric ward.   "
200380|NCT00474773|"     This study will evaluate the benefits of continuing celecoxib through six weeks of total knee     arthroplasty recovery. This is a randomized, double blind study with a group of approximately     130 primary total knee patients. All patients will receive celecoxib throughout their     hospitalization as per current minimally invasive total knee arthroplasty protocol. At the     time of hospital discharge, participating patients will be randomly placed on either     celecoxib 200mg twice a day or a placebo twice a day.      This study will determine if the continued use of celecoxib for six weeks after total knee     arthroplasty hospitalization will further decrease narcotic consumption, improve knee range     of motion, improve ambulatory ability, and improve patient satisfaction over patients     receiving celecoxib only during the acute hospitalization.   "
200381|NCT00474786|"     This is an international, randomized, open-label, outpatient, multicenter study. Subjects     will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by     intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These     investigational drugs will be administered in 6-week cycles for the duration of the study, up     to 24 months. Subjects will be stratified by nephrectomy status, duration of response to     sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC     tumor histology.   "
200382|NCT00474799|"     The purpose of this study is to characterize the repeat dosing plasma profile, extent of     accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and     morphine-6-glucuronide during administration of MNS075 in two different, clinically-relevant     dosing schedules.   "
200383|NCT00474812|"     Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. This phase II trial is studying how well dasatinib works in treating patients with     metastatic pancreatic cancer.   "
200384|NCT00474825|"     This research is being done because we do not know the best treatment for advanced Squamous     Cell Carcinoma of the Head and Neck. These cancers have been treated with a combination of     surgery, radiation and chemotherapy in varying combination. When the tumor is inoperable,     radiation therapy is used with or without chemotherapy in the hope of curing the tumor.      Recently, it has become recognized as generalized knowledge that cancer cells are hypoxic     (low oxygen concentration). Because of the low oxygen concentrations, many cancer treatments     have not been successful. The theory behind this study is to give oxygen to patients prior to     chemotherapy and radiation in hopes of generating greater results in killing cancer cells.     The purpose of this study has two main objectives. The primary objective is to determine     patient tolerance to each arm of the trial.      The second objective is to determine the feasibility of treatment delivery and acute     toxicities associated with each regimen.      It is our intention to undertake a randomized and controlled trial should this Phase I trial     prove successful in terms of patient tolerance.   "
200385|NCT00474838|"     This randomized controlled prospective study aims to evaluate the efficacy of intensive     insulin therapy for long term glycemic control and improvement or preservation of beta cell     function in newly diagnosed type 2 diabetes patients.   "
200386|NCT00474851|"     The purpose of this study is to determine whether a regimen of norethindrone acetate +     placebo or norethindrone acetate + conjugated estrogens is superior in maintaining skeletal     health and quality of life in adolescents treated with a GnRH agonist for endometriosis.   "
200387|NCT00474864|"     The rationale for this study is to determine whether GW856553 (7.5mg BD for 28 days) has an     effect on endothelial function in dyslipidaemic subjects as assessed by venous occlusion     plethysmography using brachial artery acetylcholine infusion. This will establish consistency     with preclinical findings, as well as confirm a physiologic human response at the current     safe maximal dose. Safety (specifically serum liver function testing) and tolerability will     also be evaluated in this trial.   "
200388|NCT00474877|"     This study tested the hypothesis that there would be a difference in the 12 month progression     of structural hand impairment and hand function between a group of patients with early RA who     received static resting splints and those that did not.   "
200389|NCT00474890|"     A previous study has shown very clearly that the treatment with the combination of cetirizine     and pseudoephedrine is superior to the treatment with the single agents regarding the     reduction of symptoms in patients with allergic rhinitis. These data, obtained after     controlled pollen exposure out of the pollen season, showed highly reproducible individual     responses prior to dosing. It is not clear, however, whether the same results can be obtained     during the pollen season, when additional natural pollen exposure may influence the     variability of the individual reactions.   "
200390|NCT00474903|"     This randomized phase II trial is studying the effect of esomeprazole magnesium and aspirin     on tissue PGE2 levels compared with esomeprazole and placebo. This type of chemoprevention     treatment investigates the use of certain drugs to assess whether they assist in the     prevention of cancer. The use of esomeprazole magnesium with or without aspirin may help     prevent esophageal cancer in patients with Barrett esophagus.   "
200391|NCT00474916|"     The purpose of this study is to collect beginning information on whether intravenous (IV)     administration of KRN5500 is safe and effective for treatment of neuropathic pain in patients     with cancer.   "
200392|NCT00474929|"     RATIONALE: Sorafenib and everolimus may stop the growth of cancer cells by blocking blood     flow to the cancer and by blocking some of the enzymes needed for cell growth.      PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib and     everolimus and to see how well they work in treating patients with relapsed or refractory     non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.   "
200393|NCT00474942|"     Apparent mineralocorticoid excess (AME) is a rare inherited disease that can cause severe     high blood pressure and low blood potassium in children and adults. It is caused by abnormal     hormone metabolism and can be fatal. This study will focus on the genetic basis, natural     history, disease progression, and survival of people with AME.   "
200394|NCT00474955|"     This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic     hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will     receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular     filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following     48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
200396|NCT00474981|"     This study is a cluster-randomized trial being conducted in the state of Haryana in North     India. Eighteen geographical areas served by Primary Health Centres (PHCs) have been     randomized to intervention or comparison areas. In the intervention areas, all physicians,     health workers and ICDS workers are being trained in the IMNCI. Each of these clusters has an     approximate population of 30,000.      The IMNCI intervention includes three main components:        1. improvement in the case management skills of health staff        2. improvement in the overall health system to support its performance, and        3. improvement in family and community health care practices which include:             -  prevention and management of hypothermia             -  early initiation of breastfeeding and exclusive breastfeeding             -  community-based care of low birth weight infants             -  improved care-seeking for neonatal infections      The primary outcome measures of the study are neonatal and infant mortality. The study will     also collect information on cause-specific neonatal mortality, ascertained using a     standardized previously validated verbal autopsy instrument administered by trained, skilled     health workers. All the other outcomes (including initiation of breastfeeding within 1 hour     of birth; Exclusive breastfeeding at 4 weeks of age; Proportion of neonates identified to be     sick by caregivers who sought care) are secondary outcomes.      The effectiveness of this comprehensive intervention will be measured by comparing the     primary and secondary outcome measures in the intervention and comparison clusters,     controlling for any baseline differences such as the predefined outcomes and/or socioeconomic     status and demography.      The project will serve as a guide to the Government of India of how to best implement the     IMNCI strategy and measure its impact.   "
200397|NCT00474994|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with     metastatic, locally advanced, or locally recurrent sarcomas.   "
200398|NCT00475007|"     This trial is for men and women between the ages of 40 and 74 who have a confirmed diagnosis     of emphysema. The objective of the trial is to determine the safety and effectiveness of the     IBV Valve at redirecting airflow from diseased portions of the lung to healthier areas to     achieve improvement in disease-related health status.   "
200399|NCT00475020|"     The goal of this clinical research study is to learn if using a combination of fludarabine,     busulfan, and antithymocyte globulin (ATG) can help to control myelofibrosis or     myelodysplastic syndrome in patients receiving a bone marrow or blood stem cell transplant.     The safety of these drugs will also be studied.   "
200400|NCT00475033|"     The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of     13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric     vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and     Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with     13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune     responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and     immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.   "
200401|NCT00475046|"     Background: Pregnancy was found to be a significant triggering factor for smoking cessation     and the reduction of nicotine consumption, but 50 - 70 % of mothers who stopped smoking     during pregnancy resume tobacco smoking after delivery. One main reason for the high relapse     rates is that many women are solely motivated to quit smoking for the baby’s sake. After     birth, the external reason for having quit has vanished and no other internal or external     motives exist for many women to maintain being smoke-free. Therefore, under consideration of     the Transtheoretical Model approach, relapse prevention and smoking cessation interventions     have to focus on two aspects: (1) on a specific reformulation of the stages of change for     women who show a temporarily and externally motivated change in smoking behavior during     pregnancy, (2) on intervention strategies taking advantage of the behavioral change already     done and evoking the cognitive and behavioral processes necessary for maintenance. In Germany     pediatricians are in a unique position to address this issue because nearly every mother     attends a pediatric practice for preventive examination of the newborn. Objectives: To adapt     and implement motivational enhancement interventions in pediatric practices. The aim is to     examine the effectiveness of a modified stage-matched motivational enhancement intervention     added to the common pediatricians´ advice. A second aim is the reformulation and reassessment     of the stages of change for women who have recently given birth. Methods: The study design is     a randomized controlled trial. Mothers smoking at the beginning of the pregnancy and     attending pediatric practices in West Pomerania will be assigned to an intervention group (n     = 330) and referred to a liaisonal service providing a face-to-face motivational enhancement     intervention followed by telephone brush-up sessions. A control group (n = 330) receives     treatment from the pediatrician as usual at the preventive examination. The core outcome     measures comprise abstinence, and progress in the stages of change 6, 12, 18 and 24 months     after baseline. Expected impact: Data will evaluate the usefulness of intervening in     pediatric offices and will provide information about a tailored intervention program. The     processes of change favorable for intervention in this population will be identified. This is     of great relevance with regard to the prevention of health damage for mother and child.     Furthermore, results will serve as a basis for guidelines for pediatricians to deal with     women smoking postpartum. Relationship to the objective of the collaboration: As in the other     studies, this study provides empirical data of a new proactive approach to reach underserved     populations in the addiction field. This project will add knowledge on how to intervene     (motivational enhancement vs. usual advice), on setting-specific advantages of pediatric     offices and on the impact of the chosen intervention strategy.   "
200402|NCT00475059|"     Among the different creatinine-based GFR predicting equations, the MDRD equation gives the     best prediction in renal transplantation but does not provide the level of accuracy usually     seen in renal patients with native kidneys.      Blocking the tubular secretion of creatinine with an oral administration of cimetidine is     likely to make creatinine a more accurate marker of GFR.      We will test the hypothesis that the accuracy of the MDRD equation will be improved in renal     transplant patients by incorporating into the equation a cimetidine-corrected serum     creatinine value.   "
200403|NCT00475072|"     This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients     with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms     s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks.     Following treatment there will be a 24 week period of treatment-free follow-up. The     anticipated time on study treatment is 3-12 months, and the target sample size is <100     individuals.   "
200404|NCT00475085|"     RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine,     aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which     combination of antiemetic drugs is more effective in preventing nausea caused by     chemotherapy.      PURPOSE: This randomized phase III trial is comparing different combinations of granisetron,     dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in     preventing nausea in patients undergoing chemotherapy for breast cancer.   "
200405|NCT00475098|"     Experiments suggest that low molecular weight heparin (LMWH) inhibits tumor growth and     metastasis. Studies in humans suggest that LMWH is associated with a higher survival in     patients with cancer related thrombosis. Two recent studies suggest that LMWH may increase     the survival of patients with cancer who do not have an associated thrombosis. The purpose of     the study is to assess the effect of LMWH on the overall survival of patients with localized     non-small cell lung cancer after complete surgical resection.   "
200406|NCT00475111|"     Rheumatoid arthritis (RA) is an autoimmune disease that causes long-term inflammation of the     joints and occasionally, other body tissues. The purpose of this study is to evaluate two     different types of cognitive behavioral therapy (CBT) in reducing RA disease activity and     improving mental health of adults with RA.   "
200407|NCT00475124|"     Patients with implanted pacemakers are currently seen by their cardiologists every 6-12     months. Shorter follow-up intervals are generally seen as excessive workload for the     physician, with little benefit for the patient. Longer intervals are seen as too dangerous     concerning device integrity and safety. This scheme still results in a large number of     follow-up visits with little or no important changes in pacemaker therapy.      Our clinical trial investigates efficacy and safety of the Home Monitoring technology for     increasing the flexibility in pacemaker follow-up. Home Monitoring technology allows     automatic transmission via mobile phone links of relevant data from the implanted pacemaker     to a service center. The patient's physician can access the data via a password-protected     internet site. The regular Home Monitoring data analyses entirely replace clinical routine     visits (virtual clinic). Follow-up visits are scheduled according to the results of the     Home Monitoring data analyses.      The primary endpoint of the study is to compare the total workload for pacemaker patient care     in the virtual clinic with that of standard follow-up scheme with regularly scheduled     clinical visits.   "
200408|NCT00475137|"     Depression is a medical condition characterized by feeling sad even when good things happen,     having low energy and motivation, and sometimes even experiencing suicidal thoughts. Bipolar     II Disorder is an illness in which periods of depression alternate with periods of abnormally     elevated mood, energy and activity, referred to as hypomania. After Major Depressive     Disorder, Bipolar II Disorder is the most common cause of depression. Unfortunately,     antidepressant medications, used alone, do not work as well in treating Bipolar depression as     they do in treating other kinds of depression. Lamotrigine is a medication which studies show     is effective in treating Bipolar depression. The investigators will determine if lamotrigine     works best to treat Bipolar II depression if it is used alone, or if it is taken with an     antidepressant. In the first part of our investigation, people with Bipolar II depression who     have not responded to an antidepressant will either add lamotrigine to their antidepressant,     or will stop the antidepressant and take lamotrigine alone. They will see the study doctor     for 6 visits over 8 weeks, and will answer questions about their depressive symptoms and     their overall health. The purpose of this study phase is to determine which treatment works     best to treat active Bipolar depression. In the second part of the study, people who have     responded to their assigned treatment may continue to receive it for another 44 weeks. They     will see the study doctor monthly, and will answer similar questions about their health.     Participants will also receive a physical examination and get a blood test three times during     the study. The purpose of the second phase is to ascertain which treatment is best at     preventing relapses of depression. The investigators hypothesize that people who take     Lamotrigine plus an antidepressant will recover from their depression more completely, have a     longer period of wellness, and have better quality of life compared to those taking     Lamotrigine alone.   "
200409|NCT00475150|"     This phase II trial is studying how well cediranib maleate works in treating patients with     relapsed, refractory, or untreated acute myeloid leukemia or high-risk myelodysplastic     syndrome. Cediranib maleate may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the cancer.   "
200410|NCT00475163|"     Assesing the impact of mentoring on the lifestyle choices of adolescents who are overweight   "
200411|NCT00475176|"     This study will examine the effectiveness of S-adenosyl methionine (SAMe) in combination with     peginterferon and ribavirin for treating hepatitis C virus. One out of three patients with     hepatitis C develops cirrhosis of the liver, which can lead to liver failure or liver cancer.     SAMe is a nutritional supplement that is made naturally in all cells of the body and acts to     improve how the body handles stress. In laboratory experiments with liver cells, SAMe     decreases the injury caused by liver toxins and improves the ability of interferon to block     hepatitis C virus.      Patients 18 years of age and older with hepatitis C infection who did not respond     successfully to prior treatment with interferon and ribavirin or peginterferon and ribavirin     may be eligible for this study.      Participants receive the following treatment:        -  Peginterferon (given by injection) and ribavirin (taken by mouth) for 2 weeks        -  Washout period (no medications) for 4 weeks        -  SAMe (taken by mouth) for 2 weeks        -  Peginterferon, ribavirin and SAMe for 12-48 weeks, depending on patient response to          treatment.      Participants have a thorough physical evaluation before beginning treatment and again at the     study's end. After starting treatment, patients return for clinic visits and blood tests     weekly for the first several weeks, then less frequently (at 2-week, then 4-week and 8-week     intervals until up to 72 weeks) to monitor symptoms, drug side effects, hepatitis C virus     levels, liver enzyme levels and immune responses to hepatitis C.   "
200412|NCT00475189|"     The purpose of this research study is to assess hormone withdrawal symptoms in women while     taking an oral contraceptive in the novel 24/4 (24 days of real pills) manner in comparison     to taking pills in the standard 21/7 (21 real pills) manner.      It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms     compared to the standard 21/7 regimen.      It is further hypothesized that women using the 24/4 regimen will report greater satisfaction     scores.   "
200413|NCT00475202|"     Diabetic foot ulcers are a major cause of morbidity and mortality, accounting for     approximately two-thirds of all non-traumatic amputations performed in the United States. The     cost of foot ulcers in diabetic patients averages almost $28,000 for the two years after     diagnosis of the ulcer. Hyperbaric oxygen (HBO) serves as primary or adjunctive therapy for a     diverse range of medical conditions. HBO also has been used as an adjunct to antibiotics,     debridement, and revascularization in the therapy of chronic, nonhealing wounds associated     with diabetes or non-diabetic vascular insufficiency.      The aim of the study is to assess whether hyperoxia induced angiogenesis in diabetic patients     with foot ulcers.   "
200414|NCT00475215|"     The purpose of the trial is to research the safety and to show faster recovery after     administration of 2.0 mg/kg or 4.0 mg/kg Org 25969 (sugammadex) given as a reversal agent for     Zemuron® in subjects diagnosed with or having a history of pulmonary disease.   "
200415|NCT00475228|"     This study is a randomized controlled trial of insertion of the levonorgestrel-releasing     intrauterine device (LNG-IUD) immediately following dilation & evacuation (D&E) compared to     delayed insertion 3-6 weeks post-D&E. Eighty-eight women undergoing D&E between 15 0/7 and 23     6/7 weeks gestation will be enrolled at Magee-Womens Hospital, Pittsburgh, PA. The primary     outcome is LNG-IUD usage six months following enrollment. We hypothesize that more women     receiving immediate insertion will be using the LNG-IUD 6 months after the D&E procedure than     women receiving delayed insertion. Secondary outcomes include the proportion receiving an     IUD, continuation rate, complication rates, subject satisfaction, and quality of life. The     utility of ultrasonography in predicting expulsion will also be examined. Anticipated     problems include poor subject follow-up and coordinating the intra-operative study     procedures.   "
200430|NCT00475423|"     This single arm study will evaluate the efficacy and safety of MabThera monotherapy in     patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP).     Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated     time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
200416|NCT00475241|"     The goals of the proposed research are to produce preliminary evidence of PE with OEF/OIF     veterans with PTSD and to examine cognitive, psychophysiological, and neuroendocrine     mechanisms of change in PTSD treatment. In brief, 36 OEF/OIF veterans with chronic PTSD or     PTSS of at least 3 months duration will be randomly assigned to 15 sessions of either PE or     TAU (see below for descriptions of the interventions). All veterans will receive     psychobiological assessments at pre treatment, mid treatment, post treatment, 3 months, and 6     months follow-up. Each of these assessments will cover in 2 sessions on separate days and     will include interview and self-report of symptoms (i.e., PTSD, depression, and general     anxiety severity), self-report of PTSD-related cognitions, psychophysiological (i.e., heart     rate, skin conductance, respiration, and end-tidal CO2) assessment during neutral and trauma     scripts, and assessment of salivary cortisol during neutral and trauma scripts. Also, on the     morning prior to each laboratory assessment, patients will collect salivary cortisol at the     moment of waking and 30 and 45 minutes post-walking. In addition to these assessments,     patients assigned to PE will collect salivary cortisol during three imaginal exposure     sessions (sessions 3, 9, and 15).   "
200417|NCT00475254|"     Retinitis pigmentosa (RP) patients experience a slowly progressive, unpredictable loss of     vision which eventually leads to bare or no light perception, posing a continuous threat to     patients' independence. Negative psychological states such as distress, sleepiness, anxiety     and depression are common in RP patients due to the nature of this chronic, disabling     disease. Psychophysical vision measures are more variable in legally blind RP subjects than     in normally sighted individuals, and RP patients indicate that variations in vision are often     related to stress. The primary goal of this research is to examine the vision fluctuations     within and between days among RP patients using vision tests self-administered by patients     through their home computers, and determine associations with factors such as perceived     stress, mood states, sleepiness, or light exposure. The administration of questionnaires will     allow us to gain some insight into which underlying psychological factors impact certain     vision measures, allowing the design of future interventional research to attempt to reduce     such factors. The aims of many future treatment clinical trials for RP will be to improve     vision and/or reduce the rate of vision loss; thus the sources that lead to increased     variability of vision need to be identified and alleviated to enable precise evaluation of     interventions and improve patients' quality of life.   "
200418|NCT00475267|"     The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta     valve.   "
200420|NCT00475293|"     The purpose of this study is to assess the objective response rate (ORR) when panitumumab is     administered in combination with irinotecan as 2nd-line therapy in subjects with previously     treated metastatic colorectal cancer (mCRC).   "
200421|NCT00475306|"     Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea,     vomiting, and migraine headaches in Emergency Departments. However, little research has     focused on the optimal dose of metoclopramide for treatment of nausea in the emergency     department. We propose a randomized, double-blind, placebo controlled trial to investigate     the optimal dose of metoclopramide for treatment of nausea.   "
200422|NCT00475319|"     The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye     patients   "
200423|NCT00475332|"     The purpose of this study is to determine the feasibility of treating relapsed follicular     lymphoma with a combination of Bexxar and External Beam Radiotherapy (EBRT). Patients will     receive EBRT (20 Gy in 10 fractions) followed by Bexxar.   "
200424|NCT00475345|"     The purpose of this study is to determine whether or not bedtime snacks are necessary to     prevent overnight low blood glucose reactions (nocturnal hypoglycemia) in adults with type 1     diabetes who are using intensive insulin therapies, either multiple injections of insulin or     insulin pump.      We hypothesize that a bedtime snack is not necessary if the bedtime insulin is very well     adjusted and delivered, especially by use of insulin pump which is considered the gold     standard for overnight blood glucose control.   "
200425|NCT00475358|"     Study F1J-MC-SBBT will examine the effect of duloxetine treatment in women with SUI. The     inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a     clinical diagnosis of SUI.   "
200426|NCT00475371|"     26 subjects will be enrolled into 5 different dose groups. The trial will consist of a     screening, a dosing and a follow-up visit.      Dosing at visit 2, of MKC253 Inhalation Powder, Glucagon-Like Peptide-1 (GLP-1) will be given     at 5 dose levels.   "
200427|NCT00475384|"     Objectives:      Primary:        1. To establish the feasibility of delayed infusion of ex vivo anergized donor peripheral          blood mononuclear cells (PBMC) after CD34 selected megadose haploidentical hematopoietic          stem cell transplant (HSCT) Determine the feasibility of collecting parental allogeneic          stimulator cells to induce anergy to the non-shared donor:recipient haplotype Determine          the feasibility of collecting donor PBMC as a source of T cells for ex vivo anergization          Determine the number of transplanted individuals who meet the criteria for proceeding to          delayed infusion of ex vivo anergized donor PBMC        2. To establish the safety of delayed infusion of ex vivo anergized donor PBMC by          establishing the maximal number of donor T cells that can be infused without          unacceptable graft-versus-host disease (GVHD)      Secondary:        1. To evaluate in vitro the induction and specificity of alloantigen hyporesponsiveness in          donor PBMC after ex vivo anergization        2. To assess in vitro the function of immune cells engrafted in the recipient To assess in          vitro whether alloantigen hyporesponsive donor T cells are present in the recipient          after HSCT To develop preliminary in vitro data on the extent of pathogen-specific          immunity and its rate of recovery To describe the patterns of opportunistic infections          in patients so treated   "
200428|NCT00475397|"     Study F1J-MC-SBBU will examine the effect of duloxetine treatment in women with SUI. The     inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a     clinical diagnosis of SUI.   "
200431|NCT00475436|"     GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being     developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long     duration of action of GSK573719 when administered via inhalation in animal models supports     the potential for use as a once-daily bronchodilator for COPD   "
200432|NCT00475449|"     This study compared two different methods of restoring blood flow to the heart when there has     been a narrowing or blockage in the blood vessels that supply the heart. Currently there are     two different ways of restoring blood flow. One is heart surgery where a surgeon operates     directly on the heart, through an incision in the breast bone (sternum) and takes segments of     the patient’s (non-essential) veins or arteries and then uses these to bypass blocked or     narrowed segments in the coronary arteries. This way additional blood can be “piped” into the     heart muscle wall. The second method is coronary angioplasty with stent implantation.     Coronary angioplasty is a non-surgical method performed under a local anaesthetic. During     angioplasty a special balloon is advanced to the site of a coronary narrowing, then inflated     to make it expand and this action removes the narrowing. This is a more simple and less     invasive than surgery but its value has been limited by a tendency for narrowings to     reoccur(restenosis) in the six months following the treatment. When this happens a repeat     procedure is often performed. To reduce the incidence of restenosis coronary stents are     implanted. These are tubular metal scaffold devices that are placed inside a coronary artery     at the site of a previous narrowing to help keep the artery open. These devices are usually     delivered on an angioplasty balloon and expanded into place.      Both treatments are equally effective at preventing death and subsequent myocardial     infarction and most doctors are happy to recommend either option. Angioplasty offers a more     simple initial procedure but with a chance of needing a repeat performance. Bypass surgery     represents a more significant initial undertaking with a longer recovery and convalescent     period but in most cases, provides good relief of symptoms. Patient preference plays an     important part in the decision process.      Bypass grafting is currently the therapy most frequently performed world-wide. Angioplasty     has a number of important advantages but the need for repeat procedures currently limits its     appeal.      Since these trials were performed there have been important advances in angioplasty     techniques. Prominent amongst these has been the development and use of Coronary Stents which     has been shown (in clinical trials) to reduce the need for repeat procedures after an initial     angioplasty. Consequently stent implantation is now in routine use world wide.      If angioplasty is performed with coronary stent implantation then this may reduce the need     for repeat procedures and address the principal factor currently limiting the value of this     approach. If the results were found to be as good as with bypass grafting then patients could     benefit from a shorter hospital stay, a less traumatic operation and a shorter recovery     period. We therefore wish to compare the outcomes in patients treated with a) bypass grafting     or b) angioplasty with coronary stent implantation.   "
200433|NCT00475462|"     The purpose of this study to evaluate the effectiveness of metoprolol versus conventional     treatment in the prevention of syncope recurrence in children and adolescents.   "
200434|NCT00475475|"     The purpose of this study is to investigate whether beverages sweetened with fructose promote     overconsumption of calories as compared to beverages sweetened with glucose or a non-caloric     sweetener.   "
200435|NCT00475488|"     Coronary Artery Bypass Graft (CABG)Surgery is commonly used to treat patients with coronary     artery disease (atherosclerosis) for the relief of angina (chest pain) and improve heart     muscle function.      Healthy veins or arteries, referred to as 'conduits' from elsewhere in the patient's body,     are grafted (attached) from the aorta to the coronary arteries, bypassing (via new routes)     coronary artery narrowings caused by atherosclerosis (hardening of the arteries) and thereby     improving the blood supply to the myocardium (heart muscle).      Over the years, a range of different veins and arteries from around the body have been used     to bypass diseased coronary arteries. Typically, internal thoracic arteries from behind the     breastbone and the saphenous veins from the legs are used for bypass. More recently, radial     arteries from the forearm have also been used to bypass coronary arteries that are diseased     (atherosclerotic). There is strong evidence to indicate that the left internal thoracic     artery stays open the longest (i.e. has the highest patency) and achieves the best health     outcomes. As a result, most cardiac surgeons use the left internal thoracic artery as their     first choice of conduit (vessel used to bypass the blocked artery). However, many patients     require multiple grafts and there is little evidence as to which grafts are the best conduits     to use.      It has been suggested that the radial arteries might function better than saphenous veins as     conduits. The Radial Artery Patency and Clinical Outcomes Trial(RAPCO) aims to compare     patency of the radial arteries with the right internal thoracic artery and also with the     saphenous vein.   "
200436|NCT00475501|"     The purpose of this study is to determine whether a higher-than-replacement dose of     testosterone and finasteride can be combined to safely increase muscle strength in older men     who have a low blood concentration of testosterone.   "
200437|NCT00475514|"     Although the predictability of an MRM headache attack lends itself to preventative treatment,     there are currently no drugs specifically indicated for the prevention of MM. Such     preventative therapies might be administered either short term (during the time around the     period otherwise known as the peri-menstrual period or PMP) or continuously throughout the     menstrual cycle.      Frovatriptan has been developed for the management of migraine and is already licensed for     use as an acute treatment for this condition. Previous well controlled clinical trials have     highlighted the potential of frovatriptan as a short-term preventative medication for MM.     This clinical trial was meant to further explore this indication for frovatriptan in an     expanded population.   "
200438|NCT00475527|"     Iron deficiency anemia (IDA) is a major health problem in children, effecting up to 20% of     young children. Helicobacter pylori (HP) infection is also reported to be prevalent in     children. Several large epidemiologic studies support an association between HP infection and     lower iron stores. Other small studies suggest improvement in anemia following HP treatment.      We assume that the prevalence of HP infection in Israeli children diagnosed with IDA is high     and that that adding therapy for HP in those children will improve the response to iron     deficiency.   "
200439|NCT00475540|"     The primary aim of this double-blind, randomized clinical trial (RCT) is to test the     hypothesis that the addition of a standardized technique of interpositional synthetic     polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery     for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without     mesh.   "
200440|NCT00475553|"     The purpose of this research study is to evaluate the best way to manage breakthrough     spotting and bleeding during an extended use regimen of NuvaRing®. Ease of use and     acceptability of a flexible regimen of NuvaRing® will also be evaluated. A comparison of     cyclic mood symptoms, pelvic pain, and headaches will be made between a standard 21/7 regimen     and an extended regimen.   "
200478|NCT00464789|"     Bazedoxifene/Conjugated Estrogens (BZA/CE) is an investigational drug that is being developed     for treatment of menopause. The purpose of this trial is to compare a new manufacturing     process for making BZA/CE to the current process by assessing the way it is absorbed into the     blood.   "
200479|NCT00464802|"     The primary objective is to determine the safety and tolerability of the new IV formulation     versus the current formulation of MOA-728 focusing on the theoretical potential for     infusion-related and formulation-related complications.   "
200836|NCT00478244|"     RATIONALE: In animal models, stem cells have been shown to home to the skin and repair the     biochemical and structural abnormalities associated with recessive dystrophic epidermolysis     bullosa (RDEB) (collagen 7 deficiency).      PURPOSE: To determine the safety and effectiveness of stem cell infusion in the treatment of     RDEB.   "
200441|NCT00475566|"     The purpose of this first-in-man study is to evaluate the safety and performance of the     Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with     atherosclerotic de novo or restenotic native superficial femoral and proximal popliteal     lesions.      Abbott Vascular is ceasing data analysis of the STRIDES Clinical Trial after 2 years. The     decision to discontinue the study is not related to any safety concern. The rationale for     this proposal is based on the following considerations:      The performance of DYNALINK-E from STRIDES shows no device- or procedure-related deaths and     no stent fractures, and the rate of additional revascularizations has been stable since     approximately 14 months after the procedure.      Evaluations of the bare metal nitinol DYNALINK and ABSOLUTE stents in the clinical literature     show low rates of death, reintervention and stent fracture, which are consistent with STRIDES     and demonstrate the safety of the nitinol stent platform of the DYNALINK-E.      Long-term animal studies show no concerns with the drug or polymer coating of DYNALINK-E -     everolimus tissue concentration drops below the quantifiable limit by approximately 17 months     after implant, and vascular response to the coating is normal with widely patent lumens and     struts incorporated into vessel tissue.      The safety and performance of the DYNALINK-E has been substantiated by its clinical and     pre-clinical data, and by the clinical data of similar products. Given the demonstrated     mechanical integrity of the stent along with the evidence of a healthy long-term vascular     response, there is a reasonable expectation of continued low event rates.   "
200442|NCT00475579|"     Patients mechanically ventilated using an endotracheal tube with a subglottic secretion     drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than     using a conventional endotracheal tube   "
200443|NCT00475592|"     The purpose of this study is to develop a grading system for esophageal varices using capsule     endoscopy in patients with portal hypertension and cirrhosis.   "
200444|NCT00475605|"     This is an observational study to assess the long-term safety of Protopic® Ointment for the     treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first     tacrolimus ointment exposure are eligible to participate. No drug is distributed during this     observational trial.   "
200445|NCT00475618|"     The propouse of this study is to evaluate some combined preventive measures, of easy     application in children under 6 years old as education, brush teeth, fluoride free tooth     paste,fluoridated tooth paste, professional cleaning and fluoride varnish application, to     determine between three groups of differents combined preventive measures, wich one is better     in reduting dental caries appearance.      Hypothesis:        1. Ho: Dental caries reduction percentage is larger or equal in the group with only          prevention education and Professional cleaning, than in the groups intercepted with          fluoride varnish or fluoride toothpaste.        2. Ha: Dental caries reduction percentage is less in the group with only prevention          education and Professional cleaning, than in the groups intercepted with fluoride          varnish or fluoride toothpaste.   "
200446|NCT00475631|"     Purpose:      The purpose of the study is to complete a cost analysis of the different methods used for     clubfoot treatment.      Objectives:      Short-term objective: To explore the experience of British Columbia Children's Hospital     (BCCH) with costs and outcomes related to the various forms of clubfoot management since 1984     to present.      Long-term objective: To use the information gathered in this project and apply it to future     studies in the clubfoot research program and to do a complete cost-benefit analysis.      Hypothesis: The hypothesis of the study is that the BCCH clubfoot treatment program has     better outcomes in terms of reduced financial costs than the traditional surgical management.   "
200447|NCT00475644|"     To evaluate the antitumor activity, as measured by tumor response rate, of enzastaurin in     patients with Follicular Lymphoma (FL).   "
200448|NCT00475657|"     The purpose of this study is to determine if cisplatin and pemetrexed are effective in the     treatment of patients with Small Cell Lung Cancer, extended disease.   "
200449|NCT00475670|"     This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without     a taxane for the first line treatment of metastatic breast cancer in women who have relapsed     at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for     HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading     dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by     3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or     paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study     treatment is until disease progression, and the target sample size is <100 individuals.   "
200450|NCT00475683|"     Mucositis consists of inflammation of the mucosal membrane and is a prominent cause of     patient discomfort during cancer therapy. In children receiving chemotherapy, the incidence     of oral mucositis is reported to be between 40%-70%. Curcumin, a commonly-used spice in India     and Southeast Asia, was shown in animal models to prevent chemotherapy and radiotherapy     induced mucositis. We hypothesize that curcumin may prevent oral mucosal injury and reduce     the severity of oral mucositis in children receiving chemotherapy. Thus, the aim of this     study is to determine whether in children undergoing doxorubicin-containing chemotherapy,     does supplementation of curcumin, when compared to placebo, decrease oral mucositis both by     objective (mucositis scales) and subjective (pain scale) measurements. Effective prevention     and reduction of mucosal injury may significantly improve the care we provide to children     undergoing therapy for cancer.   "
200451|NCT00475696|"     Examine the efficacy and safety of duloxetine in subjects with symptoms of bladder     overactivity due to pure detrusor instability or sensory urgency. Subjects in study will be     permitted to escalate or de-escalate between 80 mg/day and 120 mg/day in consultation with     the investigator and based on their adverse events.   "
200452|NCT00475709|"     To confirm the clinical safety and effectiveness of the Trifecta valve.   "
200453|NCT00475722|"     The purpose of this study is to help develop diets for colon cancer prevention. This study     will compare the Mediterranean diet to the Healthy People 2010 diet in 120 subjects with     increased risk for colorectal cancer.   "
200454|NCT00475735|"     The purpose of this study is to investigate the safety and efficacy of an investigational     treatment for Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.   "
200455|NCT00475748|"     ABSTRACT/EXECUTIVE SUMMARY BACKGROUND, SIGNIFICANCE & RATIONALE: Between 10-20% of the more     than 6000 cases of spinal cord injury seen annually in the North America have the clinical     pattern of traumatic central cord syndrome (TCCS). These patients are usually older, most     likely have sustained a fall, and have incomplete spinal cord injury characterized by     dysesthetic and weak upper extremities. CT scan of the cervical spine in patients with TCCS     often shows disc/osteophytes complex superimposed on degenerative or congenital spinal     stenosis and MRI reveals signal changes at one or multiple skeletal segments. A minority of     these patients suffer from fracture/subluxations, however, this group of patients are younger     and have been involved in a more dynamic trauma. Since 1951, when Schneider et al reported     this syndrome, controversy has dominated its surgical management. The current Guidelines for     the Management of Acute Cervical Spine and Spinal Cord Injuries recommendations are only at     the level of options, since prospective outcome data are unavailable.      HYPOTHESIS: in acute traumatic central cord syndrome, surgical decompression of the spinal     cord within five days will result in more rapid motor recovery, than decompression 6 weeks     following injury. To test this hypothesis, we will pursue the following specific aims:      SPECIFIC AIM I: To compare American Spinal Injury Association (ASIA) Motor Scores after three     months post injury in patients with central cord syndrome operated on within five days of     injury to a similar group of patients operated on 6 weeks following injury.      SPECIFIC AIM II: To compare functional outcome, health related quality of life and     posttraumatic syrinx size in patients with traumatic central cord syndrome operated on within     five days to a similar group of patients operated on 6 weeks following injury.      DESIGN: Single center prospective randomized study. PROCEDURE: In a two-year period thirty     patients with traumatic central cord syndrome and cord compression (15 patients in each     group) will be randomized to undergo surgical decompression either within the first five days     or at 6 weeks following spinal cord injury. ASIA motor, functional recovery and health     related quality of life between the two groups will be compared at admission, discharge from     rehab facility 3 months and 12 months after surgery.   "
200456|NCT00475761|"     Background:      Women whose mammograms show a lot of dense areas are more likely to develop breast cancer and     to have cancers that are missed by mammograms.      It is unclear why some factors lead to having dense breasts and why having dense breasts     increases the risk of developing breast cancer.      Objectives:      To determine why some women s breasts look dense on mammograms.      To determine what types of cells and tissues make up dense areas of breasts and why these     tissues may be more likely to become cancerous.      Eligibility:      Women between 40 and 65 years of age who have not had breast cancer or received medicines or     radiation for any type of cancer and who are scheduled to undergo a breast biopsy.      Design:      This study is conducted at the University of Vermont, in collaboration with the NCI.      Participants undergo the following:        -  Review of their medical records collected over the last 2 years by the Vermont          Mammography Registry.        -  Participation in a short telephone interview.        -  Height and weight measurement.        -  Testing of biopsy tissue collected for diagnosis or treatment.        -  Future contacts regarding health status for up to 10 years, including review of          additional mammograms, removed tissues, questionnaires and medical records collected by          the Vermont Mammography Registry during the 10-year study.      Participants may also undergo the following optional procedures:        -  Provide a mouthwash sample for genetic testing.        -  Provide a blood sample to test for markers of dense mammograms or breast cancer.   "
200457|NCT00475774|"     The primary purpose of the study is to examine the effect of body fat distribution on the     physiological response to a dietary fat intervention. Physiological response will be     evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance).      Secondary objectives are targeted protein production (apoB and adiponectin). Examination of     the effect of chain length of the dietary fatty acids on fat tissue characteristics and the     effect of chain length on satiety, will be studied as well.   "
200458|NCT00475787|"     The purpose of this study is to determine the effectiveness of Chiropractic management for     treatment of chronic lower back pain in older adults.   "
200459|NCT00475800|"     This 39-week, open label study is designed to assess long-term efficacy, safety and     tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who     participated in the 13-week core CCOX189A2360 study.   "
200460|NCT00475813|"     Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild     to moderate persistent asthma in pediatric subjects.   "
200461|NCT00475826|"     Study Title: Evaluation of chylomicrons metabolism in sub-clinical atherosclerosis in     patients whit Heterozigous Familial Hypercholesterolemia (FH) treated with statin plus     ezetimibe.      Background:      Coronary artery calcification (CAC) is a marker of sub-clinical coronary atherosclerosis     which correlates with higher risk of clinical events. It was already demonstrated that CAC is     more prevalent in patients with FH compared with normal individuals. A number of studies     demonstrated that plasmatic removal of chylomicrons is defective in patients with     atherosclerosis. Despite the fact that is still controversial whether this impairment occurs     in patients with HF when compared to normal controls, the kinetics of chylomicrons has not     been studied in HF patients with and without atherosclerosis and more important, it is not     clear if those changes may be observed in the sub-clinical disease, as reported for CAC in     asymptomatic individuals.      Previous studies have demonstrated the inverse correlation among LDL-C levels and the removal     of remnants chylomicrons using artificial chylomicrons technique. It is also well known that     high doses of more potent statins are more effective to remove chylomicrons from the plasma     due to better expression of LDL-C receptors through plasma LDL-C reduction. It was not     evaluated yet if the association of ezetimibe and statin, enhancing LDL-C receptors     expression in the liver would enhance the efficacy of the monotherapy with statins to remove     artificial chylomicrons in patients with HF.      Study design:      Open, randomized, single-blinded study in which twenty six outpatients from the Lipids     Clinical Unit at the Heart Institute (INCOR), University of São Paulo, previously diagnosed     with FH according to US MED PED criteria, without history of CD and a CAC evaluation by MSCT     (Multiple Sensors Computed Tomography) in the previous year will be compared to 26 control     individuals matched by age and sex collected from the database of the Lipids Metabolism     Laboratory.      Patients will be randomized to receive simvastatin 40 mg as monotherapy or in combination     with ezetimibe 10 mg and will undergoing three kinetics studies to demonstrate the effects of     simvastatin 40 mg on the kinetics of the chylomicrons along with other laboratorial dosages (     lipid fractions, hepatic enzymes and CK).      The primary endpoint of this study is to evaluate if there is any correlation among the     reduction of the plasma clearance of chylomicrons by the artificial chylomicrons technique     and the presence of sub-clinical atherosclerosis; the secondary endpoint is to evaluate if     ezetimibe/simvastatin enhances the effects of simvastatin alone in the removal of     chylomicrons in patients with HF.   "
200462|NCT00475839|"     Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of     older women. Stress urinary incontinence, the most common form of this disease, is treated     primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of     surgery being performed for recurrences. Many different surgical procedures have been     described for the treatment of SUI and there is no general agreement as to the most     effective. This study compares the safety and efficacy of the tension-free vaginal tape     procedure to the Monarc subfascial hammock procedure in the treatment of stress urinary     incontinence.   "
200463|NCT00475852|"     The purpose of this study is to find out if nesiritide (a human B-type natriuretic     peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart     failure, helps to improve breathing difficulties, reduce heart failure readmissions to     hospitals, and helps patients live longer.   "
200480|NCT00464815|"     The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority     of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.   "
201384|NCT00486122|"     The purpose of this study is to test the hypothesis that atomoxetine administered orally,     once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is     superior to placebo in children with ADHD.   "
200464|NCT00475865|"     The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide     administered once daily for 24 weeks, compared to placebo, in patients with multiple     sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA].      The secondary objectives were:        -  to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in          combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters,          relapse rate and patient-reported fatigue;        -  to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with          a stable dose of GA.   "
200465|NCT00475878|"     This study is designed to test whether treatment of depressive symptoms using escitalopram     improves adherence to Buprenorphine and reduces symptoms of depression for individuals     receiving Buprenorphine through their medical provider.   "
200466|NCT00475891|"     The study will help in identifying the best empiric antibiotic option for Linezolid resistant     Vancomycin-resistant Enterococci (VRE) infections. This research is important because it     allows the determination of resistance rates to antibiotics that may not be frequently tested     to by the clinical microbiology laboratory at UPMC-Presbyterian. It also will provide     antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in     identifying the best empiric antibiotic option for Linezolid-resistant VRE infections.   "
200467|NCT00475904|"     The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4%     amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)   "
200468|NCT00475917|"     The purpose of this study is to determine a safe dose of XL844 in combination with     gemcitabine, how often it should be taken, and how well people with cancer tolerate the     combination of gemcitabine and XL844.   "
200469|NCT00475930|"     Outbreaks of skin and soft tissue infections (SSTI) related to community associated     Methicillin-resistant Staphylococcus aureus (MRSA) have become increasingly common in     military training units. Risk factors for MRSA related SSTI such as crowding, poor hygiene     and shared equipment are often hard to avoid in a military training environment, often     designed to simulate battlefield conditions.      It has recently been demonstrated that military recruits colonized with MRSA may be at     increased risk of developing SSTI. Studies in the hospital environment have shown that     decolonizing inpatients known to carry MRSA decreases the rates of MRSA related infections in     the treated individuals and also in their inpatient unit as a whole.      The investigators propose a randomized, double blind, placebo controlled trial to:        1. Evaluate the effectiveness, feasibility, and safety of chlorhexidine body cloths,          self-administered three times weekly, in preventing SSTI among recruits in military          training facilities; and        2. Evaluate the effectiveness of chlorhexidine body cloths in decreasing rates of          Staphylococcus aureus colonization among military recruits.   "
200470|NCT00475943|"     This study will examine how the airway closes during swallowing to prevent food or liquid     from entering the voice box or lungs while eating or drinking. It will also test whether     electrical stimulation of muscles in the neck can close the airway as it would close during     swallowing. The long-term goal of this research is to determine the feasibility of a new     approach for helping patients with a severe and life threatening swallowing disorder.      Healthy normal volunteers between 18 and 65 years of age who can swallow normally may be     eligible for this study. Candidates are screened with a medical history, physical     examination, electrocardiogram and nasolaryngoscopy. For the nasolaryngoscopy, the subject's     voice box and epiglottis (flap of tissue that covers the windpipe during swallowing) are     examined using a thin flexible tube with a camera attached that is passed through the nose to     the back of the throat. During the test, speech and other tasks such as singing and whistling     are observed. The camera records the movement of the vocal cords on videotape. This procedure     may be repeated another time during the study.      Participants undergo the following procedures:        -  Electrical stimulation of muscles in the neck: The muscles in the neck are stimulated          with brief low-level electrical currents to see if the stimulation can cause the          epiglottis to fold down over the windpipe. Stimulation may be increased to a level where          it feels like a small shock The subject is asked to try to do the muscle stimulation          while swallowing.        -  Videofluoroscopy (recording swallowing and muscle stimulation during x-ray imaging of          the head): The head and neck are x-rayed while the subject swallows. After the wires          have been inserted for EMG (see below), markers are glued to the tongue and a tube is          inserted through the nose into the esophagus. The movements during swallowing with and          without muscle stimulation are x-rayed and analyzed later to determine how the          stimulation affects the movement of the epiglottis.        -  Electromyography (EMG): Measurement of the electrical activity of muscles in the neck          using fine wires placed through the skin into muscles in the chin.        -  Manometry: During the videofluoroscopy, a manometer (tube that measures pressures) is          placed through the nose and into the back of the throat at the entry point to the          esophagus. This test shows whether muscle stimulation can fold down the epiglottis.        -  Surface electromyography (sEMG): The tube used during the videofluoroscopy has small          rings embedded in it that measure muscle activity on the surface of the inside of the          throat.   "
200471|NCT00475956|"     The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in     combination with AZD0530, in treating patients with advanced solid tumours are safe,     tolerable and efficacious.   "
200472|NCT00464711|"     This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to     treatment with escitalopram in people with major depressive disorder.   "
200473|NCT00464724|"     Objectives:      The objectives of this study are to: 1) evaluate the feasibility of 3T MRSI of prostate in     improving the spectral resolution, using a PFC-filled endorectal coil, 2) develop a     systematic metabolic grading system for tumor detection by identifying the abnormal peak     areas of Cho, Cr, Po, and Ci for the prostate carcinoma, specifically from PFC-filled     endorectal 3T MRSI, and 3) evaluate the efficacy of the metabolic grading system in tumor     detection.      The long-term goal of the study is to provide an early prognostic indicator and means of     monitoring the biologic status of the prostate cancer during the course of the disease.   "
200474|NCT00464737|"     This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in     reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain,     sleep, general activity, mood, and quality of life, and the use of rescue medication to treat     pain will be assessed.   "
200475|NCT00464750|"     This study tests the reliability of thermodilution cardiac output measurements with pulmonary     artery catheters in immediate connection with heart surgery. In accordance with our clinical     practice, thermal indicator injections are synchronized with respiration. The impact on     measurement repeatability of spontaneous vs artificial ventilation and the effect of the     injectate temperature is tested.      The study hypothesis is that when injections are synchronized with the respiration, only     three injections at room temperature are needed to be within 5 % of the true cardiac output     in mechanically ventilated patients.   "
200476|NCT00464763|"     The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the     prevention of postoperative delirium in subjects undergoing heart valve surgery with or     without coronary artery bypass surgery (CABG) using cardiopulmonary bypass (CPB).   "
200477|NCT00464776|"     This study will assess the optimal renoprotective dose of Aliskiren in hypertensive type 2     diabetes patients with incipient or overt nephropathy   "
200481|NCT00464828|"     There is no data regarding success rates and incidence of carotid punctures during central     venous cannulation (CVC) in the pregnant patients. We hypothesize that because of the     anatomical and physiological changes associated with pregnancy, these patients are at higher     risk of procedure failure and carotid puncture than the general population. The purpose of     our study is to determine the success rate and incidence of carotid punctures using an     ultrasound-simulated procedure in pregnant and non-pregnant patients.   "
200482|NCT00464841|"     Combined spinal epidural anesthesia (CSE) is a very effective technique to provide labor     analgesia. One of the disadvantages of this technique is the delay in recognizing an error in     the position of the epidural catheter because of the effects of the spinal component.     Eventually in case of a misplaced catheter, the patient will experience pain or discomfort     requiring a repeat procedure after the effect of drug given during the spinal wears off. Low     current electrical stimulation test, or the Tsui test, has been used successfully to confirm     catheter location in the epidural space. The investigators' objective in this study is to     test the usefulness of the Tsui test to confirm the correct placement of the epidural     catheter during CSE in laboring patients.   "
200483|NCT00464854|"     At least 20% of patients hospitalized in the general medical and surgical wards at any given     time suffer from diabetes. It has been demonstrated that poor clinical outcome correlates     with the degree of hyperglycemia in these patients. Strict glucose control in hospitalized     patients improves clinical outcomes in the setting of acute myocardial infarction, cardiac     surgical procedures, infection and critical illness in patients hospitalized in intensive     care units if insulin is applied intravenously. It is, however, complex to obtain strict     glucose control in the general surgical and medical wards. These wards are usually     understaffed as compared to intensive care units and therefore are incapable to perform the     necessary close monitoring essential in patients treated with intravenous insulin. We intend     to test the feasibility of glucose control by multiple daily subcutaneous injections with     long acting basal glargine insulin and pre-meal insulin analogues. If good glucose control     can be achieved, this would be a valid, more convenient and acceptable alternative to     intravenous insulin infusions to obtain good glucose control in diabetic patients     hospitalized in general internal medicine wards.   "
200484|NCT00464867|"     Cholera is a major health problem of many developing countries and marked increase in the     prevalence has been seen on all continents in the last decade (WHO 1998). There is a great     need for an appropriate vaccine to protect children the principal suffers in endemic     countries, from the live threatening consequences of cholera. The B subunit-whole cell killed     vaccine (Dukoral) developed in Sweden and used in field trials all over the world. It is     licensed in many counties of the world and recommended by WHO. Protective efficacy to the     killed vaccine has been demonstrated in adults in Bangladesh as well as in other countries,     but less so in children (Clemens et al. 1986). Thus there is an urgency for developing     strategies to improve the immunogenicity of vaccines especially for protection of children in     cholera endemic countries of the world. Different options for improved cholera vaccines are     being considered including new and improved formulations of killed or live oral candidate     vaccines (Qadri et al. 2004, Sack et al. 1997, Levine et al. 1993) as well as the use of     micronutrient supplementation during the course of immunization (Albert et al. 2003, Karlsen     et al. 2003, Qadri et al. 2004). Another option that appears promising is the use of     probiotics as adjunct to oral immunization based on the understanding that these agents could     improve the mucosal immune responses, both innate and adaptive and help reducing inflammation     (Blum and Schiffrin 2003, Fang et al. 2000). A therapeutic as well as preventive role of     probiotics has been suggested from results of different studies using different probiotics     that have been tested, usually lactic acid producing bacteria such as lactobacillus,     Bifidobacterium and Steptococcus species. The supplemention of probiotics to infants may also     have a prophylactic effect against acute diarrheal diseases. In pediatric populations, the     effect of probiotic agents appears to be most significant against rotavirus diarrhea,     suggesting that an immunological mechanism is responsible for the beneficial effects     (Saavedra, 2000). In the present proposal we would like to examine if supplementation with     the probiotic Bifidobacterium breve has a beneficial role in enhancing the immunogenicity of     Dukoral in children. A two cell study will be conducted in which one group of children will     be given B. breve every day for four weeks and another group will be given placebo. Two doses     of the oral cholera vaccine will be administered at two week interval following initiation of     the probiotic/placebo administration. Pre- and post- vaccination blood sample will be     collected and assayed for immune response to the vaccine. The frequency and magnitude of the     immune response to the vaccine will be compared among the two groups of children to assess     whether the probiotic treatment enhances the immune responses to the vaccine. If probiotic     supplemenation has a positive effect on the immune response it may be adopted as adjunct to     enhance the efficacy of the cholera vaccine in immunization programmes and perhaps also of     other enteric vaccines.   "
200485|NCT00464880|"     This study will assess the reno-protective effect of renin inhibition with aliskiren as an     alternative to irbesartan in type 2 diabetes patients with incipient/overt diabetic     nephropathy.   "
200486|NCT00464893|"     Primary evaluation of the safety, tolerability and feasibility regarding specific     postoperative complications of an adjuvant treatment with catumaxomab administered after     curative tumor resection subsequent to a neoadjuvant chemotherapy.   "
200487|NCT00464919|"     The prognosis for patients with metastatic or locally advanced hepatocellular carcinoma (HCC)     is poor. The role of conventional systemic chemotherapy has been very limited because most     chemotherapeutic agents are in-effective and relative toxic to HCC patients who tend to have     poor organ function reserves due to liver cirrhosis. The molecular-targeted therapy, which     aims at deranged signaling pathways of cancer cells or their microenvironment, holds promise     for HCC.      Sorafenib (BAY 43-9006), a novel bi-aryl urea, is a potent inhibitor of VEGFR2 and Raf     kinase. The clinical activity of sorafenib in HCC has been tested in a phase II study (Bayer     study 10874), which enrolled a total of 137 advanced HCC patients. There were 4% of     documented partial response, 5% of minor response, and 55% of stable disease. The 6- month     progression -free for the cohort was 40%. Currently, there are two on-going large-scale     randomized trials of sorafenib in advanced HCC patients worldwide.   "
200488|NCT00464932|"     This study, a new immunomodulatory therapy of COPD with vasoactive intestinal peptide (VIP)     was evaluated. Based on preliminary unpublished clinical and experimental results, the course     of disease under VIP treatment and the molecular mechanisms involved were assessed.      34 patients with severe COPD were treated either with VIP inhalation in addition to     conventional therapy or inhalation of placebo plus conventional therapy for a period of 3     months. The trial was conducted as a double blind, comparative study with two parallel     groups.   "
200489|NCT00464945|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of     manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale     13vPnC in healthy infants when given with routine pediatric vaccines.   "
200490|NCT00464958|"     Open label, one year extension study to evaluate the clinical efficacy and safety of 12 mg     sublingual tizanidine administered once nightly in MS patients who successfully completed     Phase I/II protocol C2/5/TZ:MS-05 at the Tel Aviv Sourasky Medical Center, Department of     Neurology, Dr. Arnon Karni, PI.   "
200491|NCT00464971|"     This trial was conducted in the United States of America (USA). This trial aimed to evaluate     safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.   "
200492|NCT00464984|"     The long term effects of organized lifestyle intervention on weight loss, physical fitness     and quality of life in morbidly obese patients have not been extensively studied. The     objective of this study is to investigate whether an intensive lifestyle intervention program     in a tertiary care clinic (Spesialsykehuset for Rehabilitating) is superior to lifestyle     intervention in a primary care setting with respect to long term (4-years) changes in weight     loss, physical fitness and quality of life   "
200493|NCT00464997|"     High dose aspirin have been shown to increase the level of Methotrexat in patients with     Rheumatoid Arthritis. However, most of RA patients are not currently treated with high dose     aspirin. On the other hand, they frequently receive treatment with low dose aspirin. The     effect of low dose aspirin on the levels of Methotrexate is not well known. Therefore,the     purpose of this study is to assess the effect of low dose aspirin on the levels of     methotrexate.   "
200494|NCT00465010|"     Many adolescents in the U.S., even very young adolescents, are engaging in sexual risk     behaviors that put them at risk for sexually transmitted diseases (STDs) and unintended     pregnancy. Studies show that parents can play a significant role in promoting healthy sexual     development and risk reduction among adolescents. The UCLA/RAND Center for Adolescent Health     Promotion has developed Talking Parents, Healthy Teens, a worksite-based parenting program     for parents of adolescents (grades 6-10) to improve parent-adolescent communication and     reduce adolescent sexual risk behaviors. We are evaluating the effectiveness of the program     primarily with confidential surveys of the participants before and after the program.   "
200495|NCT00465023|"     The main purpose of this study is to determine if high doses of radiation using proton beam     can be given safely with low and acceptable side effects. We will also gather information to     determine the ability of proton beam to destroy cancer cells in the liver. There are two     types of external radiation treatments (proton beam and photon beam). Proton beam radiation     is a very accurate kind of treatment that has been shown to affect less normal tissue than a     regular radiation beam. The accuracy allows us to more safely increase the amount of     radiation delivered to eliminate cancer and may potentially reduce the side effects normally     experienced with standard radiation therapy.   "
200496|NCT00465036|"     Randomized trial to test the effect of flaxseed fractions on appetite regulation and     intestinal lipid absorption.   "
200497|NCT00465049|"     The standard treatment for skin abscesses in drainage followed by packing to prevent     premature closure and reaccumulation of pus. Studies from the 1950s and later conducted     outside of the US suggest that when drained abscesses are drained and sutured closed they     actually heal faster without complications. The current study compares the time to healing     and scar formation when drained abscesses are packed or sutured.   "
200498|NCT00465062|"     Gaucher disease is a lysosomal storage disorder resulting from a deficiency in the key enzyme     b-glucocerebrosidase (GCase). This enzyme is responsible for breaking down a specialized type     of fat molecule, known as glucocerebroside, in the lysosome. The enzyme deficiency is caused     by genetic mutations which result in the production of misfolded GCase protein. The absent or     defective GCase enzyme activity leads to build-up of glucocerebroside inside certain cells.     Over time, these Gaucher cells can accumulate and may cause inflammation or damage to     specific areas within the body, including the liver, spleen, bone marrow, lung, and the     central nervous system.      AT2101 is designed to act as a pharmacological chaperone by selectively binding to the     misfolded GCase. After binding to the enzyme, it is thought that AT2101 promotes the proper     folding, processing, and trafficking of the enzyme from the endoplasmic reticulum to its     final destination, the lysosome, the area of the cell where the enzyme does its work. Once it     reaches the lysosome, the pharmacological chaperone is displaced and the enzyme can perform     its normal function, which is the breakdown of its natural substrate, glucocerebroside.      Several in vitro and in vivo preclinical studies have been conducted. In these studies AT2101     increased GCase enzyme level in cells derived from Gaucher disease patients with different     genetic mutations, including cells with a genetic mutation associated with the neurologic     form of Gaucher disease. In normal mice, oral administration of AT2101 resulted in a     dose-dependent increase in GCase level in the liver, spleen, brain, and lung.      This study is designed to evaluate the ex vivo response to pharmacological chaperone therapy     by testing blood samples from previously treated and untreated patients with Gaucher disease.     The study will include patients with non-neuropathic Gaucher disease (type I) and neuropathic     Gaucher disease (types II and/or III). Up to 50 patients will be enrolled at the NIH.      All subjects will participate in one study visit. Clinical information will be collected     retrospectively from medical records. Information collected will include Gaucher disease     diagnosis and history, medical history, family history, assessments of clinical severity, and     genotype. A blood sample will be collected and various cells will be isolated for laboratory     testing and research.   "
200499|NCT00465075|"     The primary objective is to determine the effect of a high-fat meal on the bioavailability     and PK of a single, oral dose of BZA/CE (PNP) 20mg/0.625 strength tablet, assessing both the     BZA and CE components.   "
200500|NCT00465088|"     To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin     (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating     effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are     currently off lipid-modifying therapy. This was a prospective, randomized, open-label,     blinded endpoint (PROBE) study.   "
200501|NCT00465101|"     To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and     coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary     tract symptoms.   "
200502|NCT00465114|"     Severe preeclampsia often presents with uncontrolled hypertension and therefore requires     close monitoring of blood pressure and cardiac performance.      The purpose of the study is to compare two methods of measuring the performance of the heart     in pregnant women: one by ultrasound of the heart, the other by assessing the pulse generated     in the blood vessel of the wrist. We hope that the method using pulse analysis will be as     effective as ultrasound, which is labour intensive and operator dependant.   "
200503|NCT00465140|"     Creatine (CR) supplementation is commonly used by athletes. However, its effects on renal     function remain controversial. The aim of this study was to evaluate the effects of creatine     supplementation on renal function and oxidative stress in healthy sedentary males (18-35     years old) submitted to exercise training. Our hipothesis is that creatine supplementation     does not affect renal function in this population.   "
200517|NCT00466375|"     The purpose of this study is to determine if there are genes that are common in children with     infantile hemangioma. This information will allow physicians to improve care for patients who     have been diagnosed with this disease and to provide their parents with more complete     information regarding the cause of this disease. This research is being done because many     unanswered questions remain regarding children with infantile hemangioma. There are very few     medications to treat infants with hemangiomas.   "
200518|NCT00466388|"     The purpose of this study is to determine the effectiveness of cevimeline (versus placebo) on     the oral health of patients who have dry mouth which was caused by radiation therapy that was     given for treatment of head and/or neck cancer.   "
200504|NCT00465153|"     Loss of muscle mass and functional ability is a major concern for older individuals. Aging is     associated with increased inflammation caused by release of hormone-like compounds termed     cytokines which are involved in muscle protein degradation. Diets rich in ω-3 fatty acids     decrease the production of pro-inflammatory cytokines, possibly by inhibiting production of     lipids involved in cytokine synthesis. Our purpose is to assess the effect of dietary     supplementation with an ω-3 fatty acid, α-linolenic acid (ALA) commonly found in flaxseed,     combined with resistance training on pro-inflammatory cytokines, strength, and muscle mass in     older adults. Progressive resistance training is considered to be the standard for increasing     strength and muscle mass in older adults. We hypothesize that combining the two interventions     will improve strength and muscle mass more than resistance training alone by modulating the     inflammatory process associated with aging. Our proposed research will compare older     individuals supplementing with ALA and placebo during a resistance training program.   "
200505|NCT00465166|"     Accidental dural puncture is a potential complication of epidural analgesia for labour and     delivery. When it happens, it may cause debilitating headaches and other symptoms that     prevent mothers from talking care of their newborns. Accidental dural puncture is related to     the operator performance and to individual anatomical variations of the spine. The purpose of     this study is to do a lumbar spine ultrasound on the patients who have had accidental dural     punctures and analyze if there is any abnormal anatomy seen. Then, we will compare the     position of any spinal abnormality to the position of the dural puncture reported in the     anaesthesia record.   "
200506|NCT00465179|"     The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib     malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The     safety of sunitinib malate will also be studied.   "
200507|NCT00465192|"     This trial was conducted in the United States of America (USA). This trial aimed for a     comparison between the effect of two different doses of estradiol on parameters related to     efficacy and safety.   "
200508|NCT00465205|"     Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical     and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The     evidence suggests that HSV is an important co-factor in HIV transmission.      The trial's purpose is to assess the reduction in HIV systemic and mucosal replication     associated with valacyclovir for suppression of HSV-2 reactivation.      This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected     women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.   "
200509|NCT00465218|"     The purpose of this study is to determine if there is any difference in the counts of     cerebral emboli and platelet function between two prophylactic treatments of thrombosis     currently used at University of Ottawa Heart Institute for the first three months after     surgery in low-risk patients undergoing aortic valve replacement with a bioprosthetic valve:     1) daily use of high-dose aspirin [325 mgs], and 2) the combination of oral Warfarin [target     INR 2.0 to 3.0] and low-dose aspirin [81 mg].   "
200510|NCT00465231|"     Our study is about providing a better birthing experience by placing and initiating epidural     for labour pain before the contractions start. This concept of prevention of pain before its     onset is known as preventive - or preemptive -pain management and is well known in surgical     and anaesthetic practice. We believe that the use of preventive epidural analgesia will     improve the quality of labour epidurals, increase maternal satisfaction and reduce the stress     response to labour and delivery.   "
200511|NCT00465244|"     The overarching aim of STILL is assessment of IV LEV in the management of seizures in the ED     setting. The main study endpoints are considered in the two patient groups of interest (SE     and non-SE):        -  For non-SE patients, STILL will compare IV LEV vs. the current standard-care of placebo,          with respect to the following questions:        -  Does IV LEV administration result in lower seizure duration and/or recurrence rate than          does administration of placebo? (Ho: No difference in seizure duration or recurrence          rates between the two groups.)        -  Is IV LEV associated with a different rate of significant side effects than placebo?          (Ho: No difference in significant side effect rates between the two groups.)        -  For SE patients, STILL will compare [IV LEV + lorazepam 2mg] vs. [lorazepam 3 mg], with          respect to the following questions:        -  Does addition of IV LEV to a BZD allow for a BZD-sparing effect (i.e. achievement of          seizure control with lower dose of BZD)? (Ho: No difference in seizure duration and/or          recurrence rates between the two groups.)        -  Is IV LEV + lower-dose BZD associated with a different rate of significant side effects          than the higher-dose BZD administered as monotherapy? (Ho: No difference in significant          side effect rates between the two groups.)   "
200512|NCT00465257|"     The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years     after its introduction as first line treatment for uncomplicated childhood malaria in     Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted     parasitological cure rate of at least 85% 42 days after treatment.   "
200513|NCT00465270|"     The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO)     closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical     treatment in the prevention of recurrent embolic stroke.   "
200514|NCT00466336|"     The purpose of our prospective study was to evaluate the value of Doppler parameters and     compare the diagnostic accuracy of Doppler parameters with various biochemical indices in     predicting significant hepatic fibrosis (≥ F2) and cirrhosis (F4) in chronic hepatitis C     (CHC) patients.   "
200515|NCT00466349|"     This is a registry of individuals affected by Spinal Muscular Atrophy (SMA) and/or family     members of individuals affected by SMA. The purpose of the registry is to allow researchers     studying the biological basis of SMA and potential therapies in SMA access to individuals     interested in participating in research and/or experimental therapies. The International SMA     Patient Registry is supported by CureSMA.   "
200516|NCT00466362|"     There are evidence from numerous studies on effect of lifestyle intervention in morbidly     obese patients with type 2 diabetes. This study examines the effect of the Evje-model on     type 2 diabetes.      The Evje-model is a combined 12 months model, consisting of repeated stays in a specialist     centre, telephone follow-up at home, home groups, self monitoring and close contact with the     patients’ local physician.   "
200519|NCT00466401|"     The aim of our study is to Estimate the reduction of LDL by ezetimibe in hypercholesterolemic     patients on simvastatin.Investigate the effect of LDL lowering by ezetimibe on platelet     activity and LDL tendency to peroxidation in hypercholesterolemic patients on simvastatin     therapy      The hypothesis is that:        1. LDL lowering by ezetimibe on-top of simvastatin in patients on fixed dose of simvastatin          can reduce platelet aggregation, due to the potential decreasing of cholesterol content          in the platelet membranes.        2. LDL lowering by ezetimibe can lower LDL tendency to peroxidation.   "
200520|NCT00466414|"     It has been shown through research that alveolar ridges (Part of jaw bone holding teeth) tend     to lose width and height after extraction of teeth. Lost in height and width of the ridge can     cause problems in the restoration of missing teeth with bridges and implants. Hence, this     study is proposed to assess the use of polycaprolactone (PCL) scaffolds for alveolar ridge     preservation following extraction of teeth in humans.      20 patients will be divided into 2 groups. In one group, patients will have a PCL scaffold     placed into the socket after extraction. In other group, no scaffold will be placed. After a     healing period of 6 months, changes in width and height from baseline is measured for both     groups. A bone biopsy is also taken at this time from both groups. Hardness of bone,     histologic (microscopic) features of cells, percentage of living bone, radiographic density     of alveolar ridge and mechanical properties of the bone biopsy are then assessed.      This study will attempt to show that a resorbable (can be removed by body) material like a     PCL scaffold can be used to maintain physical dimensions of the alveolar ridge after     extraction and will not interfere with osseointegration (fusion with bone). It will avoid the     necessity for additional corrective surgeries for patients when alveolar ridges presented     with inadequate width and height for placement of aesthetically pleasing and functionally     sound restorations. This would improve chances of success for the patient.      If the study successfully shows that the PCL scaffold can be accepted by the body with good     bone growth, uses for the PCL scaffold can be extended to other areas of clinical medicine     and dentistry.      The PCL scaffold to be used in this study is designed and developed by a local company     (Osteopore International Pte Ltd). With the success of this product, Singapore's standing as     a biomedical hub will be further enhanced.   "
200521|NCT00466440|"     The purpose of the study is to compare the response rates for prostate cancer patients taking     chemotherapy plus enzastaurin versus chemotherapy plus placebo.   "
200522|NCT00466453|"     The purpose of this study is to compare an adaptive Web-based learning system to a     non-adaptive system for teaching physicians-in-training about ambulatory medicine.   "
200523|NCT00466466|"     This study aims to establish a tolerable dose level and regimen of RAD001 in combination with     cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage     small-cell lung cancer (SCLC) who have not previously been treated with systemic     chemotherapy.   "
200524|NCT00466479|"     This study is evaluating possible non-intraocular pressure (IOP) related effects of the     alpha-1 agonist brimonidine in human subjects affected by a progressive glaucomatous optic     neuropathy. Brimonidine was proven as neuroprotective in several pre-clinical animal studies.   "
200525|NCT00466492|"     The purpose of the study is to determine whether sedation of the critical ill patient     prolongs the time receiving mechanical ventilation.   "
200526|NCT00466505|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth     of colorectal cancer by blocking blood flow to the tumor. Celecoxib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Giving cetuximab together     with celecoxib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with celecoxib     works in treating patients with metastatic colorectal cancer or colorectal cancer that cannot     be removed by surgery.   "
200527|NCT00466518|"     This study is designed to look at the effect sitagliptin has on tacrolimus and sirolimus drug     levels in kidney transplant patients. It is also designed to look at the side effects     experienced in the transplant population.   "
200528|NCT00466531|"     RATIONALE: Using T cells from the patient that have been treated in the laboratory may help     the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy,     such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either     by killing the cells or by stopping them from dividing. Giving laboratory-treated T cells     together with cyclophosphamide may kill more cancer cells.      PURPOSE: This is a two-stage protocol, consisting of a single-institution phase I safety     study and multi-institution phase IIa extension study.   "
200529|NCT00466544|"     Study objective is to provide prospective randomized controlled data on pediatric pain levels     found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.   "
200530|NCT00466557|"     The purpose of this study is to find new ways to control malaria by looking at mosquitoes     infected with the disease. Knowledge of the genetics that affect the spread of malaria by     mosquitoes will help in developing control strategies. A small amount of blood from infected     humans will be used to infect the mosquitoes. No contact will occur between the human subject     and the mosquito. Study participants will be divided into 2 groups of 20, for a total of 40     children, ages 5-10, in Burkina Faso, West Africa. Each subject will be screened by     finger-prick once per month, from June through October, until they reach a maximum age of 10.     Two positive subjects of the 40 screened will be asked to donate about 1 teaspoon of blood,     which will be used to feed and infect the mosquitoes. Study participants will be involved in     study related procedures for a maximum of 5 years.   "
200531|NCT00466570|"     Topical ophthalmic antibiotics are common prescribed just prior to eye surgery to lower the     risk of infection. Previous studies have suggested that antibiotics containing a preservative     (Zymar) kill bacteria much quicker than those without a preservative (Vigamox). The purpose     of this research is to compare how quickly to the two commonly prescribed antibiotics     eliminate bacteria from the eye surface.   "
200532|NCT00466583|"     This is a Phase 1, open-label, non-randomized, dose-escalation study to determine the maximum     tolerated dose (MTD), safety, tolerance, and pharmacologic profile of EZN-2968, a locked     nucleic acid antisense oligonucleotide against hypoxia-inducible factor 1α administered as a     2-hour intravenous (i.v.) infusion weekly for 3 weeks per 6-week cycle. In patients treated     at a recommended Phase 2 dose of EZN-2968, dose intensification will proceed by maintaining     the dose, but gradually increasing the number of doses per 6-week cycle. Up to 3     intensification cohorts will receive the recommended Phase 2 dose of EZN-2968.   "
200558|NCT00466921|"     RATIONALE: Lenalidomide may stop the growth of mycosis fungoides/Sezary syndrome by blocking     blood flow to the cancer.      PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients     with relapsed mycosis fungoides/Sezary syndrome.   "
200533|NCT00466596|"     Twenty, house dust mite (HDM)-allergic non-smoking subjects with or without mild asthma     between the ages 18-50 will be recruited. The primary endpoint will be nasal eosinophilia.     Each volunteer will be screened with skin testing, pulmonary function testing and induced     sputum. If eligible they will return for baseline nasal allergen challenge and lavage.     Approximately two weeks later they will return for gamma tocopherol (gT) dosing visit. After     completing 14 days of daily high dose (1200mg) gT, they will return for a second nasal     allergen challenge. This visit will also include pulmonary function testing and blood draw.     The purpose of this study is to determine if high dose gamma tocopherol therapy can reduce     allergen induced nasal inflammation.   "
200534|NCT00466609|"     This will be a controlled, randomized, double-blind and double-dummy study on the treatment     augmentation strategy for obsessive compulsive disorder patients non-respondent to first line     pharmacological treatment. The investigators will compare: fluoxetine maintenance at maximum     dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the     association of fluoxetine with clomipramine.   "
200535|NCT00466622|"     FlowMet study is a sub-study of the PregMet study (registered in 2005).      The aim of the FlowMet study is to register the possible effect of metformin on the blood     flow of the uterine artery in pregnant PCOS women. The participants will be examined with     ultrasound Doppler in gestational week 10-13:        1. before and 3h after the first tablet intake of metformin/placebo        2. and 10-14 days after inclusion in the trial        3. blood flow in the umbilical artery and fetal cerebral artery in gestational week 24.   "
200536|NCT00466635|"     Approximately 65 patients will be entered into this study taking place in North America. The     aim of this study is to evaluate the safety, efficacy and absorption of an investigational     drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is     provided including doctor visits, physical exams, laboratory tests and study medication.     Total length of participation is 6 weeks.   "
200537|NCT00466648|"     This study wishes to compare patient satisfaction and cosmesis of two different closure     methods of laparoscopic ports. One method uses tissue adhesive (Dermabond) with a deep     sub-cutaneous stitch and a Band-Aid dressing. The comparison method uses a 3.o undyed vicryl     transcutaneous stitch, with a Bacitracin and Tegaderm dressing.   "
200538|NCT00466661|"     To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of     acamprosate in individuals with alcohol dependence and bipolar disorder who are also     receiving mood stabilizing medication. The study will assess the safety and efficacy of     acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use     and mood symptoms relative to placebo.      The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and     alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement     in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary     hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with     acamprosate will have greater mood stability as compared to those treated with mood     stabilizers alone.   "
200539|NCT00466674|"     Donor mobilization :      Donor will be mobilized with G-CSF (Granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days.      Hematopoïetic Stem Cell Harvest:      By 1, 2, or 3 aphaeresis, a number of 4 x 106 cellules CD34+ /kg is required. If the CD34+ >=     2 and <= 4x106/kg: the center must decide on the strategy Decision. In case of insufficient     graft : a Bone Marrow Harvest is recommended Conditioning : Fludarabine - Busulfan - ATG        -  D-5 : Fludarabine (30 mg/m²)        -  D-4 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)        -  D-3 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)        -  D-2 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg)        -  D-1 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) GVHD Prophylaxis: CsA alone at          3 mg/ kg + Methotrexate D1, D3 and D6 only in case of minor ABO incompatibility and with          an anti A/B antibodies titer> 1/32.      Transplant : HSC at D0      • 3 months after Transplantation :      Disease Evaluation :        -  If CR : Supervision. Then if progression: 4 cycles of Bortezomib.        -  If no CR : Bortezomib (4 cycles)           • Evaluation after Bortezomib cycles        -  If CR : Supervision. Then, if progression and no GvHD : DLI If no RC and no GVHD : DLI   "
200540|NCT00466687|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with     bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab     works in treating patients with stage IV melanoma.   "
200541|NCT00466700|"     H. pylori infection causes the stomach to become inflamed. The problem usually begins in     childhood and leads to stomach problems in adult life. Study participants will be residents     of The Gambia, West Africa, and will be studied at the Medical Research Council of Great     Britain facility in Fajara, The Gambia. Up to 75 adults 18 years and older and 20     malnourished children 6 months to 2 years of age, who are undergoing endoscopy as part of     their medical care, will be studied. (Endoscopy is when a thin, lighted device is used to     look inside the body.) During this study procedure, tiny pieces of tissue, called biopsies,     will be taken from the stomach and checked for H. pylori infection. Participants found to be     infected will be given antibiotic treatment. Participation in the study will last     approximately 72 hours.   "
200542|NCT00466713|"     This study will investigate the effects of rosiglitazone, a medicine commonly used to treat     type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure     which is not due to heart attacks. The primary purpose of the study is to determine whether     treatment with an insulin-sensitizing medication will improve the heart's ability to     metabolize glucose (sugar).   "
200543|NCT00466726|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of     immune cells found in bone marrow or peripheral blood. Giving booster vaccinations may make a     stronger immune response and prevent or delay the recurrence of cancer.      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients     with Philadelphia chromosome-positive chronic myelogenous leukemia.   "
200544|NCT00466739|"     In both symptomatic and asymptomatic disease, only about half of medicines are taken as     prescribed1. Relatively little is known about how patients with Parkinson's disease take     their medication. One of the challenges in the management of Parkinson's disease is the     prevention and treatment of involuntary movements2,3 and wild fluctuations between being     mobile and able to function against being slow, stiff and unable to move which recurs as a     delayed (several years) effect of taking antiparkinson medication. One theory of why this     occurs is that it is due to pulsatile rather than continuous delivery of medication to the     brain4. If patients take their medicines erratically and irregularly, this causes more     fluctuations in blood and therefore brain drug levels may prime patients for complications in     the future. This project will define the extent of irregular medication taking in Parkinson's     disease, examine associated clinical and demographic characteristics and examine the ease of     adherence to different drug regimes. Knowledge of therapy adherence will help support     patients in using their medicines to best effect. In the present document the terms     compliance and adherence are used with equal meaning.   "
200545|NCT00466752|"     This phase II trial is studying sorafenib tosylate and gene expression in patients undergoing     surgery for high-risk localized prostate cancer. Sorafenib tosylate may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow     to the tumor. Studying samples of blood and tumor tissues in the laboratory from patients     with prostate cancer may help doctors learn more about changes that occur in DNA after     treatment with sorafenib tosylate   "
200546|NCT00466765|"     The primary objectives of this study is to determine whether use of a negative pressure     external soft-tissue expansion system pre-operatively and post-operatively improves and     secures graft survival in autologous fat micro grafting breast augmentation and     reconstruction procedures.   "
200547|NCT00466778|"     This is a case-controlled study using an innovative, non-invasive, FDA approved technology to     measure the autonomic nervous system. Detection of unsuspected DPN or ANS dysfunction may     allow physicians to re-assess current treatment and develop new dietary or pharmacological     strategies. This also is an immense public health concern since there are currently 18     million diabetics in the United States and 220 million worldwide.   "
200548|NCT00466791|"     Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD   "
200549|NCT00466804|"     Injury of transplant tissue by a transplant recipient's immune system continues to be the     leading cause of graft rejection and recipient death. The purpose of this study is to     identify a single test or a combination of noninvasive tests currently used for heart     transplant monitoring that correlate to long-term graft survival.   "
200550|NCT00466817|"     Cytomegalovirus (CMV) infection is known to cause hearing loss and mental retardation. The     purpose of this study is to compare a 6-week course to a 6-month course of the drug     valganciclovir in babies born with CMV to assess the safety and efficacy of this treatment.     Participants will include 104 infants (30 days old or younger) born with CMV disease. All     infants will take valganciclovir by mouth for 6 weeks. At the end of the 6 week period,     subjects will be assigned by chance to receive either valganciclovir or placebo (inactive     substance) to complete the 6 months of antiviral treatment. Patients will be followed for the     study related evaluations of safety, changes to hearing, and developmental milestones for up     to 2 years. Patients will be followed by telephone contact for an additional 3 years. Thus,     participants may be involved in study related procedures for approximately 5 years.   "
200551|NCT00466830|"     RATIONALE: Certain psychological and social factors may increase the risk of developing     chronic pain after surgery. Evaluating these factors over time in patients who have undergone     surgery for breast cancer may help doctors plan treatment and improve patients' quality of     life.      PURPOSE: This clinical trial is studying the psychological and social factors that may     increase the risk of developing chronic pain after surgery in women with breast cancer .   "
200552|NCT00466843|"     Myelodysplastic syndrome (MDS) is a rare, potentially serious bone marrow disease. Currently     available treatments for MDS have been only somewhat beneficial. The purpose of this study is     to determine the effects of the medication antithymocyte globulin (ATG) in adults with MDS     and to determine which individuals with MDS are most likely to benefit from treatment with     ATG.   "
200553|NCT00466856|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This phase II trial is studying how well internal radiation therapy works in     treating patients with liver metastases from neuroendocrine tumors.   "
200554|NCT00466869|"     This is a randomized, double-blind, placebo-controlled, two-to three center study. The study     will consist of 2 treatment groups (Betahistine 48 mg/day or matching placebo). Approximately     30 subjects (15 per treatment group) will be randomized into this 6-week study.      A single blinded placebo treated period of up to 14 days will be used to determine subjects     suitability for inclusion in the trial.      In order that a patient will be defined as valid for inclusion in the study, patients should     be able to present consistent LDL-C values, taken prior to randomization (at screening visit     1 and screening visit 2), without deviation of more than 12% of each value from their mean.      Within one week from the second screening visit, subjects who meet all inclusion criteria and     none of the exclusion criteria will be randomly assigned to 1 of the following treatment     groups:        -  Betahistine 24 mg BID (48 mg/day total), or        -  Matching placebo BID.      Double-blind treatment will continue for 4 weeks. Study medication (betahistine and/or     matching placebo) will be administered BID (before lunch and before dinner).      During the study, subjects will undergo dietary assessment.      The primary efficacy parameter is change in LDL-C from baseline (randomization) to Week 4 and     the percentage of patients that reduce their LDL-C by 10% or more.   "
200555|NCT00466882|"     The purpose of this study is to assess the use of this Lap-Band system for the purpose of     promoting weight loss in renal failure patients who do not qualify as transplant candidates     because of excessive BMI's   "
200556|NCT00466895|"     Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.   "
200557|NCT00466908|"     The purpose of this study is to determine the accuracy of the Pentacam and IOL Master to     calculate the effective corneal power (keratometry, corneal curvature) in patients who have     undergone both corneal refractive surgery and lens extraction with intraocular lens     implantation.   "
200559|NCT00466934|"     This study will test a method of measuring brain blood flow called near infrared spectroscopy     (NIRS). It will determine whether NIRS gives the same results as the more commonly used     technique, functional magnetic resonance imaging (fMRI).      Healthy normal volunteers between 18 and 60 years of age may be eligible for this study.     Participants come to the NIH up to six times for experiments using NIRS and fMRI. They do the     following tasks while they are undergoing NIRS or fMRI:        -  looking at a computer monitor while a checkerboard pattern changes        -  wiggling the toes and moving the fingers        -  Reading words on a computer screen and pushing one button if they are plants and another          if they are animals.      For NIRS, a frame is placed on the head and held it in place with a metal band. The frame     holds sensors that contact the scalp.      For fMRI, the subject lies on a table that can slide in and out of an MRI scanner, a metal     cylinder surrounded by a strong magnetic field. fMRI uses a strong magnetic field and radio     waves to obtain images of the brain while the subject performs tasks. During the procedure,     The subject wears earplugs to muffle the sound of loud knocking noises that occur during     scanning.   "
200560|NCT00466947|"     This is a study in a large number of healthy children less than 3 years old to measure the     efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate     vaccine (Synflorix vaccine, or GSK1024850A) to prevent cases of pneumonia (lung infection)     likely caused by bacteria (Streptococcus pneumoniae and Haemophilus influenzae) or cases of     otitis media (ear infection) in children under 3 years old.   "
200561|NCT00466960|"     RATIONALE: Colony stimulating factors, such as sargramostim (GM-CSF), may stimulate the     immune system in different ways and stop tumor cells from growing and may also increase the     number of immune cells found in bone marrow or peripheral blood and help the immune system     recover from the side effects of chemotherapy. Drugs used in chemotherapy, such as paclitaxel     albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving GM-CSF     together with paclitaxel albumin-stabilized nanoparticle formulation may be an effective     treatment for ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.      PURPOSE: This phase II trial is studying how well giving GM-CSF together with paclitaxel     albumin-stabilized nanoparticle formulation works in treating patients with advanced ovarian     cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to previous     chemotherapy   "
200562|NCT00466973|"     Atrial fibrillation is an irregular heart rhythm which requires long term anticoagulation to     prevent risk of stroke and long term poor outcomes. At the same time one have heart surgery,     a small additional procedure can be done to treat atrial fibrillation. Surgeons have a choice     of six different devices that he or she can use to treat your atrial fibrillation. It is not     known at this point which device is best at treating you, as each device seems to have the     same success rate at curing atrial fibrillation. One of the six devices will be selected     randomly by card pulled out at the time of enrollment. It is therefore the purpose of this     study to compare the devices to each other and to follow up after surgery to determine if any     one device is best. This information will be valuable to surgeons and to patients as the     treatment for atrial fibrillation develops in the future.   "
200563|NCT00466986|"     The purpose of this study is to determine if the combination of Abraxane and Carboplatin     together will improve the chances of controlling recurrent ovarian/fallopian tube/peritoneal     cancer.   "
200564|NCT00466999|"     In this study, we will compare the safety and efficacy of 400 mcg sublingually administered     misoprostol alone to standard surgical care for the treatment of incomplete abortion. This     study will provide important data on the role of misoprostol in health services offering an     array of treatments for incomplete abortion. Women could significantly benefit from a     non-invasive treatment option for incomplete abortion. While safe surgical services are     becoming more widespread, there is still a serious risk of complications from these     procedures. Especially in developing countries, infection, hemorrhage and uterine damage are     still too common. Medical treatment of incomplete abortion using misoprostol would be a     tremendous step to reducing morbidity and mortality due to abortion complications.   "
200565|NCT00467012|"     To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are     administered concomitantly to patients with metastatic breast cancer.   "
200566|NCT00467025|"     This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to     estimate the improvement in progression free survival (PFS) and evaluate the safety and     tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with     advanced clear cell carcinoma of the kidney.   "
200567|NCT00467038|"     This study examines the effects of 12 months of dialectical behavior therapy (DBT) for     subjects with borderline personality disorder on aggression, anger and emotional     dysregulation. Treatment effects will be measured by changes in interview, self-report,     psychophysiology testing and fMRI neuroimaging.   "
200568|NCT00467051|"     This phase II trial is studying how well giving combination chemotherapy works in treating     young patients with recurrent or resistant malignant germ cell tumors. Drugs used in     chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving more than one drug (combination chemotherapy) may kill more tumor cells.   "
200569|NCT00467064|"     We will develop brief versions of the classic 6-week Arthritis Self-Management Program and     evaluate their effectiveness.   "
200570|NCT00467077|"     RATIONALE: Gefitinib may stop the growth of kidney cancer by blocking blood flow to the tumor     and by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2b may     interfere with the growth of tumor cells and slow the growth of kidney cancer. Giving     gefitinib together with PEG-interferon alfa-2b may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gefitinib together with     PEG-interferon alfa-2b works in treating patients with unresectable or metastatic kidney     cancer.   "
200694|NCT00468715|"     RATIONALE: Androgens can cause the growth of breast cancer cells. Antihormone therapy, such     as bicalutamide, may stop the adrenal glands from making androgens.      PURPOSE: This phase II trial is studying how well bicalutamide works in treating patients     with metastatic breast cancer.   "
200695|NCT00468728|"     This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80     (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea     (CDAD).   "
200571|NCT00467090|"     This study will identify symptoms and other characteristics of Parkinson s disease that may     be associated with changes in a gene called leucine-rich repeat kinase 2 (LRRK2). Changes in     this gene have been found in patients with and without a family history of Parkinson s     disease. This study will examine people with Parkinson s disease to try to identify how     symptoms develop over time. First-degree relatives of patients will also be studied.      People 18 years of age or older with Parkinson s disease or people who have a first-degree     relative with Parkinson s disease may be eligible for this study.      Participants visit the NIH Clinical Center every other year for 10 years for some or all of     the procedures listed below. Each visit requires 3-4 days of testing, which may be done on an     inpatient or outpatient basis. Telephone interviews are conducted during the alternate years.        -  History and physical examination.        -  Smell testing: Subjects are asked to identify 40 different scents.        -  Sensory testing: Objects with grooves and ridges are touched to subjects fingertips.          With their eyes closed, the subjects are asked to say which way the grooves and ridges          run on the objects.        -  Neuropsychological evaluation: Subjects are asked about their memory and thinking and          may be asked to complete some pen and paper tests.        -  Psychiatric evaluation: Subjects are asked about psychiatric symptoms, including anxiety          and depression.        -  Blood drawing: Blood is drawn through a needle in the arm.        -  Magnetic imaging resonance (MRI) scans of the brain: MRI uses a strong magnetic field          and radio waves to obtain images of body organs and tissues. During the test, subjects          lie on a table that can slide in and out of the MRI scanner (a metal cylinder surrounded          by a strong magnetic field). The procedure lasts about 30 minutes, during which the          subjects may be asked to lie still for up to 5 minutes at a time.        -  Transcranial sonography (TCS): TCS uses sound waves to obtain images of the brain.          Subjects lie on their back and an ultrasound device is moved around the scalp.        -  Sleep study (1-2 night hospital admission): Subjects brain waves are recorded during          sleep using electroencephalography (EEG). Their breathing rate, pulse and oxygen level          are also monitored.        -  Questionnaire: Subjects complete several questionnaires designed to obtain information          on symptoms or traits that have been reported to be associated with Parkinson s disease.   "
200572|NCT00467103|"     The purpose of this research is to utilize functional magnetic resonance imaging (fMRI) to     investigate brain reorganization for language behavior in stroke patients with aphasia. A     primary focus of the study is on recovery of nonfluent propositional speech and naming in     chronic aphasia patients. The fMRI technique is used to examine activation in the left     hemisphere (LH) and right hemisphere (RH), during recovery of specific language behaviors in     chronic nonfluent aphasia patients.   "
200573|NCT00467116|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find     tumor cells and help kill them or carry tumor-killing substances to them. Others interfere     with the ability of tumor cells to grow and spread. Cetuximab may also stop the growth of     tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to     kill tumor cells. Gemcitabine and cetuximab may make tumor cells more sensitive to radiation     therapy. Giving gemcitabine together with cetuximab and radiation therapy may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when     given together with cetuximab and radiation therapy in treating patients with locally     advanced pancreatic cancer that cannot be removed by surgery.   "
200574|NCT00467129|"     RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with     cancer may help doctors learn more about changes that occur in DNA and help doctors     understand how patients respond to treatment.      PURPOSE: This clinical trial is examining genes that affect disease outcome in patients with     metastatic colorectal cancer.   "
200575|NCT00467142|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     bevacizumab together with combination chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with     combination chemotherapy works as first-line therapy in treating patients with metastatic     colorectal cancer that cannot be removed by surgery.   "
200576|NCT00467155|"     The purpose of this study is to examine Helicobacter pylori bacteria in the stomach fluids of     children who are hospitalized and receiving nutritional care via nasogastric feeding (tube     from the nose to the stomach) to treat malnutrition. The H. pylori strains from Gambian     children may differ genetically from the strains found in the stomachs of adults from the     same community. The fluid samples will be examined for H. pylori bacterial infections that     may make children sick and unable to absorb food. Ninety hospitalized Gambian children, less     than 2 years of age, requiring a nasogastric feeding tube will have stomach fluid samples     taken via the gastric tube. Thirty mothers of children who are positive for H. pylori     bacteria will provide a sample of stomach fluid. This study may help develop treatments to     heal the stomach and improve child growth. This study will be conducted at the Medical     Research Council of Great Britain Research Laboratories and Clinical Facility in Fajara.   "
200577|NCT00467168|"     Cardiovascular complications are the leading cause of death among type 2 diabetic patients.     Postprandial triglyceride-rich lipoproteins (ppTRLs) are atherogenic. Dietary fatty acid     quality, that is, dietary fatty acid composition is related to atherogenesis. However, to     date, the overall influence of dietary fatty acid compositions on lipids in different     subfractions of ppTRLs still remains unknown among Chinese diabetic patients. This paucity of     evidence may limit the establishment of optimal recommendation of dietary fatty acid     composition for type 2 diabetes. We have 2 hypotheses:        1. Different dietary fatty acid compositions lead to differential overall responses of          lipids in four subfractions of ppTRLs over postprandial 6 h.        2. One dietary fatty acid composition will be identified as anti-atherogenesis for future          study as it can improve atherogenic ppTRLs.   "
200578|NCT00467181|"     The Primary objective is to reduce the incidence of postoperative renal dysfunction in a     high-risk subset of patients undergoing cardiac surgery on cardiopulmonary bypass with     Fenolopam, a selective dopamine-1 receptor agonist. Perioperative renal function will be     observed in 3 randomly selected groups of patients-Fenoldopam infusion at 0.03 cg/kg/min,     Fenoldopam at 0.1 mcg/kg/min or placebo      Secondary objective: will be to correlate Fenoldopam usage with postoperative clinical     outcomes such as ICU stay, hospital stay, need for inotropes/vasopressors, need for     diuretics, requirements for ECF at discharge, and overall perioperative cost reduction     through decreased ICU and hospital length of stay.   "
200772|NCT00477373|"     To assess the efficacy of Di-valproate in Bipolar I patients suffering from a manic episode     according to DSM IV (APA 1994) over a 12 weeks period of treatment.      To evaluate the clinical safety of Di-valproate.   "
200579|NCT00467194|"     RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab and sirolimus     may also stop the growth of liver cancer by blocking blood flow to the tumor. Giving     sirolimus together with bevacizumab may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of sirolimus when     given together with bevacizumab in treating patients with liver cancer that cannot be removed     by surgery.   "
200580|NCT00467207|"     The objective of this study is to gain more knowledge about the association between muscle     weakness, spasticity and motor control in children with cerebral palsy, and its relationship     to hand function.   "
200581|NCT00467220|"     The purpose of this study is to examine and compare the effects of alternate-day reductions     in calorie intake or daily calorie restriction on the risk for cardiovascular disease and     cancer.   "
200582|NCT00467233|"     The objective of this study is to evaluate laser treatment and acid peel for the treatment of     melasma.   "
200583|NCT00467246|"     Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic     Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity     and mortality, prompt intervention and coma and close monitoring are essential. The study is     designed to investigate whether a simple intervention with a long acting insulin can improve     resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten     hospital stay.   "
200584|NCT00467259|"     This study is designed to evaluate the endometrial safety of a testosterone patch as     treatment for low libido in naturally postmenopausal women.   "
200585|NCT00467272|"     Primary Objective:      -Evaluate the clinical efficacy and safety of Daptomycin given for treatment of     catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the     context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or     without initial treatment with beta lactam antibiotics.   "
200586|NCT00467285|"     Subjects with diabetes and pre-diabetes are said to have increased bone loss when compared to     the general population. Pioglitazone a thiazolidinedione, is a Food and Drug Administration     (FDA) approved oral anti-diabetic agent for the treatment of type 2 diabetes. Though there     are many benefits for using thiazolidinediones in the treatment of type 2 diabetes, there is     data that indicates that rosiglitazone therapy results in a significant decrease in total     body bone mineral density in mice. Whether it is true in humans is not clear. If the animal     data can be extrapolated to humans, thiazolidinediones may pose a significant risk of adverse     effects on bone. This study hypothesizes that treatment with the thiazolidinedione     pioglitazone may result in significant reduction in bone mineral density. The aims of this     are: 1. to evaluate the effect of pioglitazone on skeletal health; 2. to measure the bone     mineral density (BMD) of the spine and hip, as well as bone turnover markers, at different     times of persons taking thiazolidinediones and others not taking them; 3. to determine the     change in BMD and bone turnover markers within different groups at different times; and 4. to     compare these changes.   "
200587|NCT00467298|"     The study is a randomized trial of a cardiopulmonary self-management intervention to improve     functional capacity, health-related quality of life, and to reduce health care utilization.     Two hundred (100 in each group) will be recruited from VA Puget Sound Health Care System over     four years. Outcomes will be measured at three points: at entry, at the end of the 6 month     intervention, and 12 months after entry. Change in functional capacity at the end of the     intervention program is the primary outcome.   "
200588|NCT00467311|"     Hypothesis:      Cystatin C compared with creatinine is a better and earlier marker of contrast-induced     nephropathy in high and intermedium risk cardiac catheterization patients.      Primary Objective:      Establish if Cystatin C is superior detecting contrast-induced nephropathy than creatinine in     high and intermedium risk cardiac catheterization patients.   "
200589|NCT00467324|"     The objective of the study is to assess the effectiveness of the Aspire Medical Advance     System in obstructive sleep apnea by demonstrating a statistically significant mean reduction     in the apnea-hypopnea index (AHI) from baseline to 6 months, measured by polysomnography     (PSG).   "
200590|NCT00467337|"     -  To assess the efficacy of medial-wedge insole in valgus knee osteoarthritis (OA).        -  We hypothesized that medial-wedged insoles are biomechanically effective and should          reduce lateral compartment loading in persons with valgus knee osteoarthritis with a          consequent symptomatic improvement.   "
200591|NCT00467350|"     The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better     for treatment of fecal impaction in children who are constipated.   "
200592|NCT00467363|"     The primary objective of the study is to help elucidate the effects of low-dose aspirin in     combination with folic acid on the incidence of live births and spontaneous abortions among a     group of women who become pregnant compared to a control group.   "
200593|NCT00467376|"     Primary:        -  To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects          with type 1 or type 2 diabetes mellitus.        -  To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.      Secondary:        -  To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks          12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with          type 1 or type 2 diabetes mellitus   "
200594|NCT00467389|"     The purpose of this study is to determine the safety of intravenous cocaine in subjects     receiving oral donepezil.   "
200595|NCT00467402|"     This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the     prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients     will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment.     Patients demonstrating stable response at the end of the open-label treatment phase will be     assigned to receive agomelatine or placebo for 52 weeks.   "
200788|NCT00477594|"     The purpose of this study is to evaluate the safety and efficacy of extended dosing of     mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have     completed either the 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) clinical drug     trials.   "
200596|NCT00467415|"     The investigators are studying the effects of a 12-week exercise program, consisting of     either:        1. Walking on a treadmill with partial body weight        2. Functional exercise program      The investigators would like to know the effects these two exercise programs have on the     quality of life, muscle strength and control, coordination, walking, and functional movement     of children with cerebral palsy who are marginal ambulators. This is a randomized control     trial with subjects randomly assigned to one of the 2 groups.Subjects in both groups will be     seen twice a day for two weeks at our hospital for intervention and parent training, and then     participate in a 10 week home-based program. During each subject's two-week clinic-based     training, a parent or caregiver is trained in all home program exercises and/or equipment     usage. This person must be able to safely perform the exercise program with the child. Each     subject will also need to participate in three separate 5-hour long data collection sessions     scheduled over the 4 month study period.   "
200597|NCT00467428|"     The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in     adult patients.   "
200598|NCT00467441|"     The purpose of this study is to determine the safety and efficacy of VSF-173 compared to     placebo in treatment of induced excessive sleepiness.   "
200599|NCT00467454|"     The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in     10 subjects with pyromania.   "
200600|NCT00467467|"     To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms     and quality of life.   "
200601|NCT00467493|"     Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent     breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary     for the production of estradiol. This class of drugs, aromatase inhibitors, are very     effective in reducing estradiol levels in postmenopausal women and in treating estrogen     receptor positive breast cancers. This study is examining the effect of a specific inhibitor,     anastrozole, on endometrial thickness in premenopausal women. The endometrium is sensitive to     estradiol and also has local aromatase which, if inhibited, may result in reduced endometrial     thickness. The main hypothesis is that anastrozole can be administered at any time during the     menstrual cycle and reduce endometrial thickness compared to placebo.   "
200602|NCT00467506|"     Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy     using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with     reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling     time lower than 5 years)   "
200603|NCT00467519|"     Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in     US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection,     booster response and safety of this formulation as a 5th dose.      Primary Objective:      - To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular     pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all     antigens) when each is administered as a 5th dose and given concurrently, to children aged 4     to 6 years.      Secondary/Observational Objectives:        -  To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine          (for pertussis antigens) when each is administered as a 5th dose and given concurrently,          to children aged 4 to 6 years.        -  To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after          each long-term follow-up.        -  To describe the safety profile following vaccine administration.   "
200604|NCT00467532|"     The purpose of this study is to evaluate the effect of burn injury on the human immune system     with a focus on cytomegalovirus (CMV) reactivation and the immunologic correlates of latent     viral reactivation.      Subjects will be patients admitted to the North Carolina Jaycee Burn Center with burn injury.      Blood samples will be collected over time and will be evaluated for CMV reactivation and     immune cell phenotype.   "
200605|NCT00467545|"     This study is to evaluate the safety of telbivudine for up to 21 months of open-label     treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial.     Patients treated with telbivudine during core phase will continue telbivudine and patients     treated with entecavir during core phase will be switched to telbivudine if the patient is     willing to enroll this study.   "
200606|NCT00467558|"     The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in     compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will     receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will     be effective in reducing the urges to act out sexually in patients with compulsive sexual     behavior. The proposed study will provide needed data on the treatment of a disabling     disorder that currently lacks a clearly effective treatment.   "
200607|NCT00467571|"     Previous studies suggest that chronic idiopathic thrombocytopenic purpura is associated with     Helicobacter pylori infection. The objective is to study the effect of Helicobacter pylori     eradication on platelet count.   "
200608|NCT00467584|"     The purpose of this study is to determine whether aspirin is effective for treatment of     fatigue caused by multiple sclerosis (MS).   "
200609|NCT00467597|"     The ultimate goal of this proposal is to reduce dyskinesia in Parkinson's Disease (PD)     patients. Dyskinesias are abnormal movements, often caused by the standard treatment for PD     symptoms, levodopa. In this study, we will test if biochemical devices are equal to the     clinical rating system in measuring dyskinesias.   "
200610|NCT00467610|"     This is a Phase II, open-label clinical trial examining the role of Panhematin® in patients     with MDS. The objective of this study is to evaluate the safety and efficacy of Panhematin®     (hematin for injection) in the treatment of adult patients (≥ 18 years of age) with low-risk     MDS.      The study will be conducted on an outpatient basis and will consist of the following:        -  A Screening Period (within 28 days of the Day 1)        -  Screening bone marrow aspiration and biopsy up to 60 days prior to receiving study          medication        -  An 8-week Treatment Period (Days 1 through 4 of Week 1, and weekly visits during Weeks 2          through 8); partial and complete responders in any of the three cell lines may continue          treatment for an additional 4 weeks        -  A 6-month Post treatment Follow-up Period (monthly clinic visits during Weeks 12 40)   "
201455|NCT00487682|"     To investigate the efficacy and safety of three different doses of ASP2151, as compared to     valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended     clinical dose.   "
200611|NCT00467623|"     Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully     elucidated how this is reflected in the total and cobalamin saturated transport proteins,     transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin     into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins     and cobalamin analogues.      Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd,     39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo)     was measured by in-house ELISA methods.   "
200612|NCT00467636|"     The purpose of this study is to determine the effect of preventing hyperglycaemia in patients     admitted to hospital with acute exacerbations of chronic pulmonary disease.   "
200613|NCT00467649|"     This will be a randomized, open label, parallel group, multicenter study. There will be two     phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of     regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients     with type 2 diabetes who have either been on a prior regimen of insulin for less than 6     months and were taking less than 50 U total of insulin per day OR are candidates for the     initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore     further intensification of diabetes regimens in patients failing to achieve HbA1c <=6.5% at     Week 24.   "
200614|NCT00467662|"     Recurrent cold sores - herpes simplex labialis (HSL) occurs in 20-40% of the US population     and patient seek treatment because of the discomfort and visibility of the lesion although it     is a self limiting disease. The purpose of this study is to check the safety, Efficacy and     convenience of Use of the Natural Agent Superlysin Gel as Treatment for Herpes Labialis in     Comparison to Acyclovir 5% and Docozanole 10%.   "
200615|NCT00467675|"     In a previous study we used the FreeStyle Navigator Continuous Glucose Monitoring (CGM)     System to obtain 30 days of glucose measurements from 30 people with diabetes treated with     insulin. The purpose of this study is to characterize glycemia (glucose) control in 30 people     without diabetes and to compare these data to the 30 people with diabetes from a previous     study. Through this approach it may be possible to develop a means of establishing a model of     normal glucose patterns and a basis of comparison with glucose patterns in people with     diabetes.   "
200616|NCT00467688|"     The objective of this cross over study is to access if continuous glucose monitoring (CGMS)     with a real time feed back and hypoglycemic as well as hyperglycemic glucose alerts vs. only     retrospective analysis of glucose values is able to improve course of glucose with special     regard to time spent in hypoglycemic glucose ranges in type 1 diabetic patients with impaired     hypoglycemia awareness or a history of severe hypoglycemia. The second objective is to access     satisfaction with CGMS during both conditions   "
200617|NCT00467701|"     The aim of the study is to investigate the bacterial causes in community acquired pneumonia     in adults admitted to hospital in two counties in Norway and to look at possible factors that     makes the patients susceptible to pneumonia.   "
200618|NCT00467714|"     The role of strut in rhinoplasty has been debated for many years and many research has been     made over this problem but there is no significant data for descision of surgeon, so this     study was designed to evaluate the effect of columellar strut in tip projection and rotation.   "
200619|NCT00467727|"     To determine if diagnostic phase contrast mammography (PCM) will provide improved image     detail in assessing lesion characteristics when compared to diagnostic x-ray mammography     (XM).   "
200620|NCT00467740|"     The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL     inhalation solution delivered by the Respimat® inhaler for four weeks in patients with     asthma. The selection of the optimum dose(s) will be based on bronchodilator efficacy (how     well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount     of the medication found in your blood).   "
200621|NCT00467753|"     The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine     vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty     subjects between the ages of five and seventeen with a diagnosis of autism.   "
200622|NCT00467766|"     A unique multinational study was conducted simultaneously in the USA, England and Australia.     The goals of the study were to answer two questions: Does psychosocial support for the family     enhance the effectiveness of drug treatment for Alzheimer's disease? Is the added value of     psychosocial support the same in all 3 countries?   "
200623|NCT00467779|"     This non-randomized, open-label, study will determine the highest safe dose of cobimetinib,     how often it should be taken, how well participants with cancer tolerate cobimetinib and will     assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.   "
200624|NCT00467792|"     The purpose of this study is to determine how long the skin lesions usually last and what     kind of symptoms and signs children with urticaria pigmentosa may develop over the years.     This information will allow physicians to better care for patients who have been diagnosed     with this disease and to provide their parents with more complete information regarding what     to expect for the future of their child. This research is being done because many unanswered     questions remain regarding children with urticaria pigmentosa and its course.   "
200625|NCT00467805|"     The study investigates an acute effect of white-appearing LED light (with a peak in blue     portion) vs. red LED light of similar irradiance on reproductive hormones in healthy women.   "
200626|NCT00467818|"     Published studies on omega 3 fatty acids in the treatment of bipolar disorder and     schizophrenia have shown reductions in time to recurrence, a decrease in the positive and     negative symptoms of schizophrenia, and improvements in CGI, YMRS, and HAM-D scores. The     following are the hypotheses:        -  Omega 3 fatty acids will be superior to placebo in the acute treatment of global autism.        -  Omega 3 fatty acids will be superior to placebo in improving aggression and irritability          associated with autism.        -  Omega 3 fatty acids will be superior to placebo in improving functional ability.   "
200789|NCT00477607|"     RATIONALE: Alpha-lipoic acid may prevent or lessen hearing loss caused by cisplatin.      PURPOSE: This randomized clinical trial is studying the effectiveness of alpha-lipoic acid in     preventing hearing loss in cancer patients undergoing treatment with cisplatin.   "
201456|NCT00487695|"     The purpose of this study is to determine if confocal laser endomicroscopy (CLE) can improve     detection of Barrett's esophagus, dysplasia, and early esophageal cancer.   "
200627|NCT00467831|"     This study will examine whether five drugs (pravastatin, Losartan, Zileuton, N-acetylcysteine     and erythromycin) used together can slow the course of pulmonary fibrosis (scarring of the     lung tissue) in patients with Hermansky-Pudlak Syndrome (HPS). Patients with this disease     have decreased skin color (albinism), bleeding problems, and sometimes colon problems. Two of     the known types of Hermansky Pudlak syndrome, type 1 and type 4, are at high risk of     pulmonary fibrosis between the ages of 30 and 50.      Patients 18 to 70 years of age who have Hermansky-Pudlak Syndrome with a serious loss of lung     function due to pulmonary fibrosis may be eligible for this study.      Participants begin taking pravastatin on study day 2 and start a new drug every 3 days.     Patients who experience no problems with the medicines return home and continue on the drugs     for the next 2 years. They return to the NIH Clinical Center every 3 months for a medical     history, physical examination, and blood, urine and lung function tests. CT and bone density     scans are done every year. The study may continue for up to 3 years.   "
200628|NCT00467844|"     The purpose of this study is to assess if Gtx-024 is effective in increasing lean body mass     in subjects with muscle wasting related to cancer.   "
200629|NCT00467857|"     The purpose of this study is to determine if there is a qualitative reduction in microbial     skin flora post-surgery compared to pre-surgery when a cyanoacrylate based microbial sealant     is used in combination with a surgical skin preparation solution.   "
200630|NCT00467870|"     To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of     serum total testosterone.   "
200631|NCT00467883|"     Evaluation after 4 weeks of treatment or at end of treatment if it occurs before. Efficacy     will be defined as objective responses; complete and partial response.   "
200632|NCT00467896|"     A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution     delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 Power 15 Study   "
200633|NCT00467909|"     Nutritional deficiencies are a major problem in school children in India and have a variety     of adverse effects on their cognitive development and growth, and increase susceptibility to     infections. There is strong evidence for beneficial effects of iodine, iron and     protein-energy on cognitive development in children, while evidence for vitamin B6, vitamin     B12, folate, zinc and, omega-3 fatty acids and in particular docosahexanoic acid (DHA) is     limited and inconclusive. A randomised, double-blind, placebo-controlled 2x2 factorial design     will be conducted to assess the effect of a micronutrient with or without omega-3 fatty acids     on cognitive development and performance and other selected outcome variables such as growth,     morbidity and immune response in children of 7-9 years of age in India.   "
200634|NCT00467922|"     The purpose of this study is to find out if guided fluid administration with the esophageal     monitor is superior to standard fluid administration and whether use of the hetastarch or     lactated ringers offers different benefits with respect to length of stay in the hospital     after hand-assisted colorectal surgery.   "
200635|NCT00467935|"     This is a trial aimed at patients with advanced wet macular degeneration and macular scarring     treated wiht intravitreal injections of Lucentis.   "
200636|NCT00467948|"     Patients who need major head & neck surgery are at risk of post operative wound infection. In     spite of role of antibiotics in prophylaxis of clean contaminated head and neck surgery has     been well documented, controversy exists in the optimal antibiotic regimen   "
200637|NCT00467961|"     This study will try to improve the safety and effectiveness of stem cell transplant     procedures in patients with cancers of the blood. It will use a special machine to separate     immune cells (T cells) from the blood of both the donor and the patient and will use     photodepletion, a laboratory procedure that selectively kills cancer cells exposed to light.     These special procedures may reduce the risk of graft-versus-host-disease (GVHD), a serious     complication of stem cell transplants in which the donor's immune cells destroy the patient's     healthy tissues, and at the same time may permit a greater graft-versus-leukemia effect, in     which the donated cells fight any residual tumor cells that might remain in the body.      Patients between 18 and 75 years of age with a life-threatening disease of the bone marrow     (acute or chronic leukemia, myelodysplastic syndrome, or myeloproliferative syndrome) may be     eligible for this study. Candidates must have a family member who is a suitable tissue match.   "
200638|NCT00467974|"     The current randomized controlled trial comparing LEM and TACE aims to evaluate the safety     and efficacy of LEM as compared to TACE for treating patients with unresectable HCC.   "
200639|NCT00467987|"     The purpose of this study is to examine the effects of testosterone deficiency in men with     diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity .   "
200640|NCT00468000|"     This study is designed to evaluate the safety and efficacy of autologous Vascular Repair     Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb     ischemia.      The double-blind study is expected to enroll 150 patients, randomized into two patient     groups. The treatment group will receive intramuscular (IM) injections of the VRCs into the     affected limb; the control group will receive intramuscular injections with an electrolyte     solution (without cells). Both groups will receive the standard of care appropriate for their     medical condition.   "
200641|NCT00468013|"     In this study 60 people with medically unexplained physical symptoms (MUPS) will receive     either a 6-session resilience skill building intervention provided fully online or a weekly     computerized journaling assignment. Both programs can be completed from home. Participants     will complete questionnaires both before and after the intervention and changes in symptoms,     mood and satisfaction with life will be assessed.   "
200642|NCT00468026|"     The purpose of this ex-vivo study is to evaluate the insertion procedure for the ProstaPlant     implant in human prostates and the support that it supplies to the prostate.   "
200643|NCT00468039|"     This study will evaluate the effects of treatment with vildagliptin and metformin as initial     combination in newly diagnosed patients with type 2 diabetes who have very high levels of     HbA1c and/or fasting plasma glucose.   "
200791|NCT00477633|"     This is a non-comparative study. the primary objective of the study is to assess the efficacy     of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are     to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of     the product.   "
200644|NCT00468052|"     Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery     carried out in children who very often also present with obstructive sleep apnea. To provide     pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl.     These narcotics are known to depress respiration and to increase the incidence of     post-operative nausea and vomiting. These side effects are worrisome in this patient cohort.     An alternative medication, dexmedetomidine, may have an opiate sparing effect and has a high     safety profile in adults as well as in sedation in children. The purpose of this study is to     determine if intravenous dexmedetomidine given as an infusion during general anesthesia for     tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence     agitation, improves analgesia and reduces nausea and vomiting in the 60 minutes following     surgery.   "
200645|NCT00468065|"     The objective of this study is to evaluate the effectiveness of the VeinViewer® near infrared     device to facilitate the placement of intravenous catheters in children who require     intravenous cannulation in the pediatric emergency department. This clinical protocol is     designed to determine whether using the VeinViewer increases the ease and efficiency of IV     cannulation (as perceived by the operator), decreases the time to effective cannulation,     decreases the number of sticks and extravasations, and decreases the child's and the parents     perception of the pain of IV cannulation.   "
200646|NCT00468078|"     The purpose of this study is to determine whether F-18 FPCIT is effective and safe     radiopharmaceutical for the objective diagnosis of Parkinson's disease.   "
200647|NCT00468091|"     The purpose of this study in humans is to define the effects of the endogenous hormone GLP-1     on gastroduodenal motility and on endocrine pancreatic secretion by using the specific GLP-1     receptor antagonist exendin(9-39). To elucidate possible cholinergic pathways, we combined     exendin(9-39) with the muscarinergic antagonist atropine.   "
200648|NCT00468104|"     The purpose of this study is to document the efficacy and safety of intrapleural instillation     of Activase vs Placebo in the management of complicated pleural effusions and empyemas   "
200649|NCT00468117|"     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells     are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess     the benefit of islet transplantation in type 1 diabetic (T1D) kidney transplant recipients.   "
200650|NCT00468130|"     Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and     irritability in autistic individuals as shown by reductions in the Aberrant Behavior     Checklist-irritability subscale.      (2) Aripiprazole treatment will be superior to placebo in the acute treatment of global     autism severity.      The purpose of this study is to examine the possible benefit of the medication Aripiprazole     in autistic individuals.   "
200651|NCT00468143|"     The purpose of this pilot study is to compare Adderall ® and Adderall XR ® in terms of their     effectiveness and side effects for the treatment of ADHD in adults.   "
200652|NCT00468156|"     The main aim of this study is to determine if persons can increase fruit and vegetable     intakes if they make a specific plan to do so.   "
200653|NCT00468169|"     The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®)     added to two concurrent chemoradiotherapy platforms of different intensity in locally     advanced head and neck cancer.   "
200654|NCT00468182|"     The purpose of this study is to determine whether interferon-beta impairs the ability of     plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple     sclerosis.   "
200655|NCT00468195|"     The purpose of this cardiovascular imaging research is to look at ways to improve the way we     can look at the pictures of the heart. Patients undergo CT scans of the heart for a variety     of reasons, including symptoms and/or tests suggestive of coronary artery disease (chest     pain, shortness of breath, abnormal stress test, follow up exam of known/existing coronary     disease, abnormal calcium score, etc.) This study involves finding ways to optimize quality     of the scan in persons of size. This is because in patients with a BMI (body mass index) of     greater than 40, it is usually difficult to see all the arteries around the heart     satisfactorily. Body mass index is a number that we can get by putting your height and weight     in a formula. The purpose of this study is to use a new computer software program to help us     interpret your heart study.   "
200656|NCT00468208|"     Wegener's granulomatosis (WG) is a rare disease that causes inflammation of blood vessels, or     vasculitis. It may involve many different parts of the body, but typically affects the upper     and lower respiratory tract and kidneys. The purpose of this study is to determine the safety     and effectiveness of the medication abatacept in treating adults with mild relapsing WG.   "
200657|NCT00468221|"     The purpose of this research study is to learn more about the effects of 0.12 ppm ozone     exposure on humans. We know from other studies that exposure to levels of ozone that are seen     on bad air pollution days, can cause an increased risk of illness and even death in some     people with certain health problems like asthma and heart disease. We also know from studies     we have done in our lab that even healthy people can have an inflammatory (an increase in the     amount of bacteria fighting cells) response to high levels of ozone. We suspect that exposure     to low levels of ozone makes the body more susceptible to things like allergens. For     instance, in persons allergic to pollen, exposure to ozone in the environment may cause them     to have more allergy symptoms when they are around pollen than they would have if they were     not exposed to ozone first. In this study we are looking to find the lowest level of ozone to     which healthy people can be exposed without seeing that increased immune response. We will     use 0.12 ppm ozone; this is roughly the amount of ozone you would be exposed to on a yellow     ozone day in the triangle area in the summer if you spent the entire day out of doors and     exercising moderately.   "
200675|NCT00468468|"     Mentor Integration Project      This study will investigate the benefits of CHESS, a Human Cancer Mentor and the potential     additional benefit of combining CHESS and a Cancer Mentor compared to Internet access for     women diagnosed with breast cancer. Our goal is to advance interactive cancer communication     systems, thus improving quality of life for patients and families facing cancer, especially     underserved populations.      Primary Aims:        -  Determine if the Internet, CHESS, a Cancer Mentor, or a combination of CHESS and the          Cancer Mentor improve quality of life for women with breast cancer        -  Determine which of the above conditions is most effective        -  Determine which of the above conditions is most cost efficient   "
200658|NCT00468234|"     The proposed study will evaluate biomarkers measured in exhaled breath condensate (EBC) for     the purpose of assessing clinical strategies of harm reduction. It will take advantage of a     recently developed device that permits collection of exhaled breath condensate reproducibly,     with minimal subject effort and with no oral contamination. The major goal of the trial is to     provide evidence to validate biomarkers in EBC.      This will be accomplished by collecting samples from asymptomatic smokers before and after     inducing a change in their smoking habit (cessation or reduction) with the aid of partial     nicotine replacement.      Measures to be made in EBC include H2O2, the most widely explored biomarker in this body     fluid. Methods that reliably can quantify levels in normal non-smokers and in asymptomatic     smokers will be used. Two fold increases in smokers have been reported by in several reports     and confirmed in preliminary data by the investigators. In addition, other biomarkers of     oxidant stress: TBARs, 8-isoprostane and nitrotyrosine will be quantified using standard     methods.      Biomarkers quantified in EBC will be assessed for reliability (i.e. reproducibility and for     sensitivity) to change and for validity (by comparison to clinically defined endpoints and     previously validated measures of exposure). Reproducibility will be assessed by making     repeated measurements in the same subjects on different occasions. Sensitivity to change will     be assessed by comparing values before and after changing smoking habit. Finally, the     validity of the biomarkers will be assessed by comparing them to previous measures of smoke     exposure (CO, NNAL and NNAL-glc) and to clinically defined endpoints: symptoms, the St.     George's Respiratory Questionnaire and post bronchodilator lung function. With regard to the     latter measures, preliminary data indicate that symptoms can be detected in asymptomatic     smokers and that these can change with a harm reduction strategy.   "
200659|NCT00468247|"     A multicentre, open, RCT to assess the safety and efficacy of the Navigator Guided     Circulatory Management System versus conventional care in post-operative cardiac surgery     patients. The purpose of the study is to demonstrate that the real time acquisition and     subsequent processing and display of data produced by the Navigator guided circulatory     management system provides the clinician with appropriate data and guidance to achieve and     maintain a prescribed target haemodynamic stability in the post operative patient when     compared to conventional care in an Intensive Care Unit setting.   "
200660|NCT00468260|"     To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with     advanced malignancies.   "
200661|NCT00468273|"     The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune     Globulin Intravenous (Human) [IGIV], 5% Solution Omr-IgG-am™ in patients with primary     immunodeficiency diseases.   "
200662|NCT00468286|"     The study will have two treatment groups, evaluating two Degarelix doses. First dose is the     initial dose followed by a maintenance dose given every three months. The initial dose given     to suppress the testosterone level and the three month maintenance dose to maintain the     suppressed testosterone level over one year of treatment.   "
200663|NCT00468299|"     The purpose of this study is to compare two combinations of drugs (mifepristone and     misoprostol versus placebo and misoprostol) used for medical treatment for early pregnancy     failure. We will compare the two combinations of medications to see which combination makes     miscarriage happen faster. We hypothesize that there will be no difference in time to     complete miscarriage between the two groups.   "
200664|NCT00468312|"     This study is designed to assess the effectiveness of mometasone furoate nasal spray (MFNS)     once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in     reducing the total symptom score.   "
200665|NCT00468325|"     This is a prospective, randomized multicenter trial comparing MSCT to standard of care (SOC)     diagnostic treatment in the triage of Emergency Department (ED) low to intermediate risk     chest pain patients. Our hypotheses are that compared to SOC treatment, MSCT is equally safe     and diagnostically effective, as well as more time and cost efficient.   "
200666|NCT00468338|"     The BIS monitor is a tool which assists anesthesiologists in monitoring the depth of     anesthesia or level of anesthesia. The study doctors would like to see if it is useful tool     for patients who are mentally challenged and require anesthesia.   "
200667|NCT00468351|"     Intravitreal triamcinolone has been effective for central macular thickness reduction and     concomitant visual acuity improvement in patients with diabetic macular edema (DME). VEGF is     a very effective inducer of permeability, being 50.000 times more potent than histamine, and     may exert its effect on retinal vascular permeability by altering tight-junctions proteins,     such as occluding and VE-cadherin. Based on these principles, there is a rationale for     anti-VEGF agents treatment of increased retinal capillary permeability conditions, such as     diabetic macular edema. Therefore, we conducted a randomized, prospective study to compare     the efficacy and safety of intravitreal triamcinolone acetonide and intravitreal bevacizumab     injection for refractory diffuse DME.   "
200668|NCT00468364|"     Long-acting insulin injected at bedtime may cause hypoglycemia (low blood sugar) in the night     in patients with diabetes. The aims of the study are 1) to compare the dynamic     characteristics of long-acting insulin analog glargine with those of NPH insulin and placebo     during the night and the early morning hours, 2) investigate differences on glucose     metabolism of bedtime glargine versus NPH insulin at induced hypoglycemia.   "
200669|NCT00468390|"     To evaluate the effect of capsaicin in patients with Complex Regional Pain Syndrome.   "
200670|NCT00468403|"     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells     are destroyed, resulting in poor blood sugar control. The purpose of this study is to     determine the safety and effectiveness of islet transplantation using a steroid-free,     calcineurin-inhibitor-free belatacept based immunosuppressive medication, for treating type 1     diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic     episodes.   "
200671|NCT00468416|"     The purpose of this study is to evaluate the safety and effectiveness of the NiTi CAR device     in the creation of colorectal anastomosis   "
200672|NCT00468429|"     This study analyzes the safety and efficacy of off-label Subconjunctival Injection of     bevacizumab (Avastin) versus 0.02% mitomycin C (MMC) for preventing bleb failure following     glaucoma filtration surgery.   "
200673|NCT00468442|"     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells     are destroyed, resulting in poor blood sugar control. The purpose of this study is to     determine the safety and effectiveness of islet transplantation, combined with the     immunosuppressive medications and medications to support islet survival for treating type 1     diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic     episodes.   "
200674|NCT00468455|"     The purpose of this study is to produce a user-friendly tool- in the form of a questionnaire     - to accurately assess early quality of life in patients after abdominal colorectal surgery     from the first day after surgery to 6 months after. The study will also compare this     questionnaire to the other currently available assessment tools. Patients are invited to     participate if they are undergoing abdominal colorectal surgery at University Hospitals of     Cleveland.   "
200678|NCT00468507|"     Patients undergoing major surgery, trauma and burns are prone to develop an exacerbated     inflammatory response, which is potentially lethal to the individual. Recently our group     demonstrated that administration of high fat feeding prior to hemorrhagic shock attenuates     severe inflammation, gut barrier loss and hepatic damage. High fat feeding releases     cholecystokinin in the gut, which stimulates the autonomous nervous system and subsequently     activates the efferent vagus nerve. The activated efferent fibers inhibit tissue macrophages     via binding of acetylcholine to the alpha7-nicotinergic receptor.      In this study the cholecystokinin release in healthy volunteers is monitored in response to     low fat and high fat food products.   "
200679|NCT00468520|"     The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening.     It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption     that the combination results in a more successful labor induction. Scientific validation of     this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves     induction success.   "
200680|NCT00468533|"     A short term post-market monitoring of serum prolactin level change among patients with     schizophrenia shifting from other antispychotics to different dosages of aripiprazole.   "
200681|NCT00468546|"     This study will assess the safety and efficacy of rituximab combined with MTX in participants     with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor     Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the     target sample size is 500 participants. Eligible participants may receive re-treatment with     rituximab under a separate protocol WA17531.   "
200682|NCT00468559|"     The purpose of this study is to look at the improvement of a once a day dose of esomeprazole     for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD).     This research study consists of a screening, open-label, and double-blind treatment     withdrawal phase. The screening phase ensures the patient eligibility. No study medication is     dispensed during the screening phase. During the open-label phase, patients are administered     esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase,     the patients are administered either his/her open-label dose or placebo. Double-blind means     neither the physician, parent, or patient will know if patient is taking esomeprazole or     placebo. The patient will have an equal chance of receiving esomeprazole or placebo.   "
200683|NCT00468572|"     This study will examine the effects of tending to significant social relationships on     managing and reducing stress.   "
200684|NCT00468585|"     The purpose of this study is to find out what effects (both good and bad) that capecitabine     has on you and your breast cancer when given in a novel schedule in combination with the     antibody therapy, bevacizumab. Capecitabine (Xeloda®) is an anticancer drug that was approved     by FDA in 1998 for treating metastatic breast cancer. Capecitabine is a pill that blocks the     way cancer cells multiply and grow. Usually, this medicine is taken twice a day for fourteen     days in a row.      Patients then get a break from the drug for seven days. With this schedule and usual dose,     some patients on capecitabine have experienced side effects that interfered with their daily     comfort.Different doses and schedules of capecitabine have been studied in animal studies and     in people with colon cancer. Mathematic modeling has been used to better understand these     results.Information from these experiments leads us to ask if 7 days of treatment with     capecitabine followed by a 7-day break is both safer and more active against breast cancer.     The study you are considering is a first step in this direction and is designed to     demonstrate both safety and activity.      Bevacizumab is a biologic therapy that targets the growth of blood vessels which tumors need     to grow. Women whose breast cancer spread to other parts of their bodies lived longer without     their cancers growing when they were treated with bevacizumab and chemotherapy. Bevacizumab     was tested with the 14-day/7-day schedule of capecitabine. These two medicines are safe when     given together and seem to work better against breast cancer than capecitabine alone.      This study is designed to answer the questions:        1. What are the side effects of bevacizumab and capecitabine when given in this different          schedule and how often do they occur?        2. When given in this schedule, does capecitabine with bevacizumab help treat breast cancer          that has spread or continues to grow despite being treated by other chemotherapy drugs          before?   "
200685|NCT00468598|"     This survey has two aims. First, we would like to be informed about the health condition of     our patients two years following heart surgery at University Hospital, Basel. Second, we are     interested in determining whether a patient's long-term outcome can be predicted by the     analysis of blood samples taken shortly after heart surgery.Troponin T, the blood parameter     that we are interested in, is routinely assessed in the Intensive Care Unit. The purpose of     this survey is to determine whether or not it is also possible to infer the long-term outcome     from this blood parameter.   "
200686|NCT00468611|"     This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects     with Secondary Progressive Multiple Sclerosis (SPMS)   "
200687|NCT00468624|"     Approximately 50% of middle-aged patients with severe AGHD have a normal age-related serum     IGF-I. It remains unclear if in these individuals serum IGF-I is GH dependent or independent.     This study compared the relationship between GH and serum IGF-I in two cohorts of male     patients with severe AGHD; one with normal and the other with subnormal age-related serum     IGF-I values. The GH receptor antagonist - pegvisomant was be used to specifically inhibit GH     action and the changes in markers of the GH axis, such as serum IGF-I, IGFBP-3, GH and GHBP     were measured.   "
200688|NCT00468637|"     The purpose of the study is to evaluate the influence of cardiovascular risk factors, heart     failure and cardiovascular drug therapy on erectile function in cardiovascular high-risk     patients.   "
200689|NCT00468650|"     A multicenter open label study to assess the efficacy of sildenafil rapid dose titration to     100 mg in men with erectile dysfunction, based on the Erectile Function (EF) domain score of     the International Index of Erectile Function (IIEF) questionnaire.   "
200690|NCT00468663|"     An epidemiologic study of pregnant women in western Washington to measure the relationships     between exposure to air pollutants and risks of preeclampsia and preterm delivery.   "
200691|NCT00468676|"     This study will evaluate the effectiveness of a nurse-led case management intervention in     improving disease control and depression symptoms in adults with diabetes and/or heart     disease who are also depressed.   "
200692|NCT00468689|"     This study will evaluate the safety, tolerability and exposure of SB-751689 when administered     alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a     PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable     the planning and conduct of a QTc study for SB-751689.   "
200693|NCT00468702|"     This study will measure the efficacy and safety of an early postoperative anticoagulation     self-management program, using the CoaguChek S device, in patients undergoing mechanical     valve replacements. Patients will be randomized into a study group (self-management) or a     control group (physician management).   "
200696|NCT00468741|"     Component and Couple Analysis of Cancer Communication      CHESS, the Comprehensive Health Enhancement Support System is an innovative technology that     provides information, social support and skills training to women with breast cancer.     Previous CHESS clinical trials found improved patient outcomes but little is known about what     services in CHESS produce those results. This study will examine whether breast cancer     patient outcomes change when conceptually distinct CHESS services (information, social     support, and skills training) are systematically added to a patients treatment resources.      Primary Aims:        -  Determine the relative efficacies of different types of cancer communication treatments          when they are presented alone or in combination        -  Determine routes or processes via which these elements work        -  Determine for whom the different treatment types work best.   "
200697|NCT00468754|"     This trial will compare the metabolic control in type 1 diabetes obtained by continuous     infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro     and glargine, a long-acting insulin analogue. Patients will be switched to the alternative     treatment after 4 months. Glucose variability in the last month of each treatment will be     analyzed.   "
200698|NCT00468767|"     This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion     of atrial fibrillation to sinus rhythm.   "
200699|NCT00468780|"     The objective of this study is to evaluate the reliability and validity of acuity estimates     by paramedics employing the Canadian Triage Acuity Scale (CTAS) in the out of hospital     setting. The study has the potential to help guide policy decisions pertaining to the safe     transfer of ambulance patients to alternative destinations reducing ED overcrowding and     ambulance off load time. Emergency Department triage nurses employ the same acuity scale and     if this study is successful the emergency departments and the EMS services could communicate     about capacity to handle patients based on acuity, volumes and waiting times.   "
200700|NCT00468793|"     Perioperative goal directed fluid therapy by means of an esophageal doppler has been shown to     reduce morbidity and length of stay. In this study patients undergoing elective bowel surgery     will be randomised to traditional fluid therapy with crystalloids versus fluid boluses guided     by central venous oxygen saturation. The primary outcome will be complications after surgery.   "
200701|NCT00468806|"     The purpose of this study is to look at how much of a new drug, GSK598809 binds to specific     proteins in the brain and how much stays in the blood over a range of different doses.   "
200702|NCT00468819|"     In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has     already been approved for application in adults, will be investigated in children and     adolescents. MRI is a modern and safe examination method without delivering radiation burden     using magnetic fields to produce cross-sectional images of the human body. A special computer     program then puts these images together and creates a two or three-dimensional image of the     inner organs thus facilitating the detection and evaluation of pathological changes. In     contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the     examination which results in a stronger contrast in the examined area. Therefore,     pathological changes can be more easily detected and evaluated compared to non-enhanced MRI.     The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called     Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine.     Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e.     in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney     disease. Gadavist was examined in more than 2,900 adults within the framework of clinical     studies during development and has been used after its marketing authorization in meanwhile     more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only     conducted with adults so far. Diseases requiring MRI examinations, however, often occur in     children, too. Therefore, many contrast agents are already used on a regular basis in MRI     examinations of children, some of these contrast agents being authorized already. Within the     framework of this study the pharmacokinetic characteristics of Gadavist in children or     adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in     the body. In addition, safety and tolerability will be evaluated in order to demonstrate that     Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents.     Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body     weight also for this population group.   "
200703|NCT00468832|"     The purpose of this study is to establish the largest long-term assessment of people with     Duchenne muscular dystrophy (DMD). In this study, the investigators associated with the     Cooperative International Neuromuscular Research Group CINRG) will take a detailed look (for     a minimum of eight years) at DMD participant's physical abilities, the medical problems they     experience, and how they use health care services. Physical abilities will be compared to a     group of healthy controls.      The second purpose of this study is to find out whether small, normal differences in the     genetic makeup of people with DMD (called single nucleotide polymorphisms or SNPs) affect     how their disease progresses and relates to muscle strength/size and steroid response.      The third purpose of this study is to study genetic variations associated with DMD.      The final purpose of this study is to determine whether certain biomarkers are present in     people with DMD and not in healthy controls.   "
200704|NCT00475969|"     To see if duloxetine 60 to 120 mg once daily (QD) is better than placebo in the treatment of     generalized anxiety disorder (GAD).   "
200705|NCT00475982|"     The purpose of this study is to determine if weight loss prior to radical prostatectomy     effects chemical substances in the blood stream and prostate tissue that may affect prostate     cancer development and progression.   "
200706|NCT00476008|"     The purpose of the study is to determine whether memantine delays the progression of driving     impairment in patients with mild Alzheimer's Disease (AD).   "
200707|NCT00476021|"     This study is a randomized controlled trial comparing 6 month usage rates of the     levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after     vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of     unintended pregnancy in the United States, particularly in postpartum women, there is a need     for reliable, effective, long-term contraception such as the IUD in postpartum women.     Postplacental insertion of intrauterine contraception would help to address this need. The     primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal     delivery will be higher in women who have immediate postplacental insertion as compared to     delayed insertion 6-8 weeks following delivery.   "
200708|NCT00476034|"     This 39-week, active controlled, study is designed to assess long-term efficacy, safety and     tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who     participated in the 13-week core CCOX189A2361 study.   "
200709|NCT00476047|"     This phase II trial studies how well tositumomab and iodine I 131 tositumomab works in     treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)     that have had their first decrease in or disappearance of signs and symptoms of cancer (first     remission). Monoclonal antibodies, such as tositumomab and iodine I 131 tositumomab, may     block cancer growth in different ways by targeting certain cells.   "
200710|NCT00476060|"     The standard treatment for decompensated cirrhosis is liver transplantation, however, it has     several limitations. Recent animal studies suggest that bone marrow stem cell transplantation     can lead to regression of liver fibrosis. The investigators have already completed the phase     1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with     cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results     (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find     efficacy of this new treatment strategy in the setting of a multicenter, randomized     placebo-controlled trial in 50 patients with decompensated cirrhosis.   "
200711|NCT00476073|"     Open, parallel group design. The study has a screening phase and a 12 week treatment phase.     Subjects will be randomised to treatment in a 1:1 ration.   "
200712|NCT00476086|"     The purpose of this research study is to determine the feasibility and safety of giving the     combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether     or not this drug combined with radiation therapy works in treating women with Mullerian     tumors of the uterus.   "
200713|NCT00476099|"     To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol     pMDI in a twice daily regimen in patients with stable severe COPD.   "
200714|NCT00476112|"     This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of     atrial flutter (AFL) to sinus rhythm.   "
200715|NCT00476125|"     This study will examine the potential changes in the blood levels of a recently discovered     metabolic regulator in response to changes in diet in healthy adults. Our hypothesis is that     in healthy adults key regulatory factors involved in lipid oxidation will respond to changes     in diet, particularly fasting and diet-induced ketosis.   "
200716|NCT00476138|"     The present study attempts to evaluate the potential beneficial effects of a flavonoid, the     epigallocatechingallate, on retinal ganglion cell function, evaluated by pattern     electroretinogram, in subjects with ocular hypertension or early glaucoma.   "
200717|NCT00476151|"     This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1     Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the     lower extremities due to diabetic nerve pain.   "
200718|NCT00476164|"     Purpose of clinical trial; Evaluate the effectiveness of rituximab in C4d+ CAN      Primary objective; To determine whether anti-CD20 therapy can stabilize or improve renal     function and/or proteinuria in patients with C4d+, chronic (humoral) rejection in whom     standard therapeutic approaches have failed.      Secondary objective (s);        -  To compare patient and graft survival between control and rituximab-treated groups        -  To evaluate the adverse effect profile of rituximab in this group        -  To correlate changes in circulating B cell numbers, anti-HLA and non-HLA Ab profiles and          titre with responses to standard therapy and / or rituximab        -  To correlate changes in T cell responsiveness to alloantigens with responses to standard          therapy and / or rituximab      Study Design; Prospective, randomised, two arm, open-labeled      Study Endpoints; Primary        -  Rate of deterioration in renal function, defined by slope of reciprocal creatinine plot,          on samples taken 3-5 months post-randomisation.        -  Change in degree of proteinuria, where present, at 3-5 months post-randomisation 2˚          endpoints, determined at 3-5 months post-randomisation and at 1, 2 and 3 years          post-recruitment are;        -  Rate of deterioration in renal function, defined by slope of reciprocal creatinine plot,          determined by analysis of samples taken since previous assessment.        -  Patient survival        -  Graft survival        -  Incidence of culture positive infection        -  Incidence of malignancy        -  Degree of proteinuria        -  Changes in circulating CD20+ cells in peripheral blood        -  Changes in anti-graft Ab titres, (measured every 3 months)        -  Changes in T cell responsiveness to alloantigens (measured every 3 months).      Sample Size; 15 patients to be randomised to each arm (i.e. 30 patients randomised). Up to     120 patients will need to be enrolled into the study. In addition, in those participants that     received a living donor kidney, these donors will be approached to provide up to 5 samples of     blood to help with the in vitro analyses.      Summary of eligibility criteria;        -  Male or female renal allograft recipients 18-70 years of age        -  more than 6/12 post-transplantation        -  Either deteriorating allograft function on reciprocal creatinine plot or significant          proteinuria or both.        -  C4d+/- CAN on renal allograft biopsy      Investigational medicinal product and dosage; Rituximab, 1g on day 0 and 1g on day 14      Active comparator product(s); None      Route(s) of administration; Intravenous infusion      Maximum duration of treatment of a subject; 14 days with rituximab. The treatment arms of the     study, including optimisation period, formal run-in and post-randomisation phase lasts for 10     months post-recruitment.      Procedures; Screening & enrollment. Potentially eligible patients will be identified by     screening renal allograft biopsies performed for 'creeping creatinine' and/or proteinuria.     Recruitment by informed consent prior to enrollment.      Procedures; Baseline. In addition to routine tests, blood for anti-HLA and non-HLA antibody     analysis and for peripheral blood mononuclear cell (PBMC) purification.      Procedures; Treatment period. 3 month run-in period on optimal conventional immunosuppressive     therapy, preceded by up to 2 months to allow tailored-optimization. Patients will be reviewed     at least six times in their normal transplant clinic appointments for routine blood     biochemistry, full blood count and urine analysis. At the end of the run-in period, further     blood will be taken for anti-graft antibody analysis and PBMC purification. Those patients in     whom allograft function stabilises and/or proteinuria improves will have normal transplant     clinic follow-up appointments and have blood taken for further anti-graft antibody and PBMC     purification up to every 3 months for 3 years. Those with continued deterioration in either     allograft function or persisting or worsening proteinuria will be randomised. These patients     will be reviewed during their normal transplant clinic appointments until the primary     end-point and will need to have at least 6 routine blood biochemistry, full blood count and     urine analysis during the final 3 months of this period, post-randomisation. At the primary     end-point, further blood will be taken for anti-graft antibody analysis and PBMC.      Procedures; End of Study. •Follow up will continue for 3 years, with blood taken for     anti-graft antibody analysis and PBMC purification every three months      Procedures for safety monitoring during trial; Regular patient interviews and examination,     routine haematological and biochemical analyses. Serious adverse events will be reported and     forwarded to the sponsor, MHRA, LREC and Roche as appropriate The WLRATC transplant research     committee will discuss the trial and any safety concerns at their regular three monthly     meetings. Data will be reviewed after 30 and also after 60 people have been enrolled.      Criteria for withdrawal of patients on safety grounds; Serious adverse effects related to     rituximab infusion   "
200719|NCT00476177|"     The purpose of this study is to test the safety of adding donor dendritic cells to donor     lymphocyte infusions, and to determine the type and severity of any side effects associated     with this addition. Previously patients with hematologic malignancies who relapsed after     transplant have been given infusions of donor white blood cells (donor lymphocyte infusion,     DLI) as a way to boost their immune function and fight disease. Although DLI has led to     cancer regression in some patients, the overall response rate using DLI alone is low, and     unfortunately, rarely lasting. Researchers have discovered a new subset of blood cells,     called dendritic cells (DC), which are crucial partners to lymphocytes in generating an     immune response. We believe that the infusion of DC together with DLI may improve the ability     of the donor lymphocytes to recognize and kill cancer cells.   "
200720|NCT00476190|"     The purpose of this study is to determine the safety and effectiveness of a multi-drug     chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a     regimen that is often used in pediatric patients and we will add drugs called     PEG-asparaginase and E. coli asparaginase. PEG-asparaginase has been given as an injection in     the past and has been used in treatment with both children and adults with ALL. Information     from those other research studies suggests that intravenous PEG-asparaginase has been     administered safely in both children and adults. We hope to gain more information about the     participants disease and how it responds to standard chemotherapy drugs used to treat ALL>   "
200721|NCT00476203|"     This purpose of this study is to test whether a 6-month yoga program improves quality of life     and reduces fatigue and weight gain in breast cancer survivors.   "
200722|NCT00476216|"     There is a direct association between cancer and thrombosis (blood clots). The purpose of     this study is to determine the best dose of an antithrombotic (prevents blood clots) agent     called fondaparinux in non-small cell lung cancer(NSCLC). Patients will also receive     chemotherapy.   "
200723|NCT00476229|"     Primary Objective:      1. To determine whether the primary endpoint: the composite success rate, defined as the     proportion of patients who are alive at day 100; and are without grade 3-4 Graft versus Host     Disease (GVHD); and are without grade 4 toxicity (unrelated to infection); and have     engrafted, is likely to be at least 40%.      Secondary Objectives:        1. To determine the cumulative incidence of chronic graft versus host disease.        2. To determine the overall and disease free survival.   "
200724|NCT00476242|"     Prospective participants will undergo a screening process at the clinic to determine     eligibility. After screening, eligible patients will complete an 8-day inpatient     detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to     one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid.     Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month     (the total of three injections) while memantine or placebo will be taken daily. In addition,     patients will receive twice weekly psychosocial intervention that will include motivational     interviewing and cognitive-behavioral relapse prevention. The outpatient treatment will also     consist of 3 weekly visits to the clinic in which patients will receive counseling to help     maintain abstinence and improve compliance with study medication.   "
200725|NCT00476255|"     This study examines the Pediatric Emergency Department as a location for increasing safe car     seat practices by parents who are not restraining their children appropriately in motor     vehicles. Three different intervention will be tested to determine their effectiveness in     increasing safe car seat practices: usual emergency department care; provision of printed     materials; and a brief motivational intervention in the emergency department.   "
200726|NCT00476268|"     Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with     moderate to severe persistent asthma.   "
200833|NCT00478205|"     The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the     currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with     moderate to severe Alzheimer's disease.   "
200727|NCT00476281|"     Diabetes is a important complication of cystic fibrosis (CF). The improved life expectancy of     patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an     increasing prevalence of cystic fibrosis-related diabetes (CFRD). CFRD is associated with     accelerated pulmonary decline and increased mortality. Pulmonary effects are seen some years     before the diagnosis of CFRD implying that impaired glucose tolerance may be very early     detrimental. Insulin treatment is clearly indicated in patients with CFRD to control symptoms     and reduce complications. However, at the state of impaired glucose tolerance or fasting     hyperglycaemia, current screening methods are not suitable for the early management of     hyperglycaemia.The recent introduction of the continuous glucose monitoring system (CGMS),     which provides a continuous glucose profile, has revealed to be clinically relevant in the     investigation of glucose excursions over a long period. This device, widely use in diabetic     non cystic fibrosis patients, has been validated in non diabetic cystic fibrosis subjects.     Previous studies of continuous glucose monitoring have been realized in CF patients with     normal glucose tolerance and diabetes and compared with non CF controlThe aim of our study is     to evaluate the glucose profile with continuous glucose monitoring the nutritional and     respiratory status in cystic fibrosis subjects, according to their glucose tolerance.   "
200728|NCT00476294|"     Objectives:      The objective of this long-term observational study is to assess progression-free survival     and overall survival for a period of five years following the first dose of study treatment     (placebo or plerixafor [AMD3100]) in protocol AMD3100-3102. Patients that received at least 1     dose of study treatment (placebo or plerixafor) in the multicenter, randomized, double-blind,     placebo-controlled AMD3100-3102 study, which was designed to evaluate plerixafor plus     granulocyte colony stimulating factor (G-CSF) versus placebo plus G-CSF to mobilize     hematopoietic stem cells for autologous transplantation of Multiple Myeloma (MM) patients are     eligible.   "
200729|NCT00476307|"     This study is designed to test the immunogenicity and reactogenicity of the     Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008     season.   "
200730|NCT00476814|"     Primary Sclerosing Cholangitis (PSC) is a chronic disorder of the liver causing jaundice and     liver damage. When Cystic Fibrosis affects the liver, the damaged liver looks like the liver     in PSC. This study is designed to answer the question whether isolated PSC may be a form of     CF only in the liver   "
200731|NCT00476827|"     Our hypothesis is that this study design, in which bevacizumab is added to one of six single     agent chemotherapies with proven activity in metastatic breast cancer, will result in     regression or stabilization of this disease in a safe and tolerable manner.   "
200732|NCT00476853|"     A 48 week, randomized, open-label, two arm study to compare the efficacy, safety and     tolerability of HAART containing nevirapine 400 mg/day versus nevirapine 600 mg/day in HIV-1     infected patients started at 2-6 weeks after initiating rifampicin containing     antituberculosis therapy.   "
200733|NCT00476866|"     Background: To determine whether intermittent positive-pressure breathing (IPPB) improved     lung compliance, work of breathing, and respiratory function in patients with recent high     spinal cord injury (SCI).      Methods: Two months of IPPB and two months of conventional treatment have to evaluated     prospectively in random order in 14 patients with SCI. Noninvasive lung function tests and     arterial blood gas measurements have to be obtained repeatedly. Repeated measurements of     dynamic compliance and work of breathing have to be performed in 7 of the 14 patients.   "
200734|NCT00476879|"     The purpose of this study is to examine the effects of growth hormone during fasting in     healthy lean men.   "
200735|NCT00476892|"     The aim of this study is to determine the effectiveness and cost-effectiveness of pelvic     floor muscle training in the management of pelvic organ prolapse in women.   "
200736|NCT00476905|"     The goal of this clinical research study is to evaluate the use of an imaging technology     called spectral diagnosis. Researchers want to find out if a special spectral-diagnosis probe     can be used to detect skin cancers.   "
200737|NCT00476918|"     Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular     edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage     versus a low dosage.   "
200738|NCT00476931|"     The purpose of the study is to study the clinical effects of the investigational drug, SB-509     versus placebo in patients with diabetic neuropathy.   "
200739|NCT00476944|"     The purpose of this study is to compare the rates of vascular related complications in     patients undergoing percutaneous coronary intervention assigned to one of two arms: 1)     bivalirudin + provisional Gp IIB/IIIA use versus 2) heparin + Gp IIB/IIIA (eptifibatide     (Integrilin®)) use.   "
200740|NCT00476957|"     The PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200     hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late     stent thrombosis resulting in less deaths and myocardial infarctions.      Study Stents:      Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System or next generation model Cordis     Cypher® Sirolimus-eluting Coronary Stent, Cordis Cypher Select® Sirolimus-eluting Coronary     Stent or next generation model      Primary Objective: To compare overall stent thrombosis rate of the Endeavor® Zotarolimus     Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a     patient population requiring stent implantation      Secondary Objective: To compare the composite endpoint of total death or cardiac death     combined with the number of patients with all non-fatal myocardial infarctions as well as the     number of patients with large non-fatal myocardial infarctions for Endeavor® Zotarolimus     Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a     patient population requiring stent implantation.      To assess the safety and efficacy in patient subgroups with specific demographics, clinical     indications and/or vessel- or lesion characteristics.   "
200741|NCT00476970|"     The goal of this study is to implement and in a controlled randomised trial test a program to     identify and overcome barriers to CRC screening and thus improve CRC screening rates at MGH     Chelsea HC.      Our hypothesis is that a bilingual navigator program, enhanced by using trained interpreting     staff will improve CRC screening rates at MGH Chelsea HC overall, and decrease disparities     between patients with limited English proficiency and English speakers   "
200742|NCT00476983|"     Pharmacokinetic and long term efficacy of TDF SQV film coated tablet 1500/100mg once daily     plus TDF/FTC300/200mg once daily.   "
200743|NCT00476996|"     This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in     patients with active rheumatoid arthritis who have an inadequate response to at least one     anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous     ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment     will be administered at weeks 24 and 26. All patients will receive stable doses of either     concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive     additional DMARDs. The anticipated time on study treatment is 1-2 years. Target sample size     is 1000.   "
200744|NCT00477009|"     The purpose of this study is to evaluate effects from a mandibular repositioning appliance on     obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and     cardiovascular health in patients with mild to moderate obstructive sleep apnea/hypopnea     syndrome and in patients with symptomatic snoring.   "
200745|NCT00477022|"     the objective of this study is to evaluate the impact of vacuum-compression effects of     Vasotrain on the diabetic foot ulcers using stereological method based on Cavalieri’s     principle in diabetic patients.   "
200746|NCT00477035|"     The purpose of the study is to conduct a phase I study of adoptive immunotherapy with     autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate     in autologous stem cell transplant patients with high-risk hematologic malignancies.   "
200747|NCT00477048|"     Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who     have chronic indinavir (IDV) associated nephrotoxicity.   "
200748|NCT00477061|"     The purpose of the study is to evaluate morphine effect on pain reduction and diagnostic     accuracy in patients admitted to emergency ward with the diagnosis of acute appendicitis.   "
200749|NCT00477074|"     The role of HGF and KGF in COPD is poorly known. Plantier et al found that cultured     fibroblasts harvested from patients with emphysema produced less HGF (but similar amounts of     KGF) than controls, and Bonay et al found a direct relationship between the severity of     airflow obstruction and HGF mRNA content in lung samples of smokers. These two studies     suggest, therefore, that the pulmonary regulation of HGF may be abnormal in patients with     COPD. However, both HGF and KGF can also be released by extra-pulmonary organs, thus having     the potential to act systemically. Given the current clinical relevance attributed to the     systemic effects of COPD, in this study we compared the levels of HGF and KGF in the     pulmonary (bronchoalveolar lavage (BAL) fluid) and systemic compartment (circulating blood)     of smokers with and without COPD and never smokers.   "
200750|NCT00477087|"     The purpose of this study is to evaluate the effect of the combination of mitoxantrone and     GM-CSF on time to progression in patients with hormone-refractory prostate cancer.   "
200751|NCT00477100|"     The goal of this research study is to collect blood and tissue samples and clinical data from     patients with inflammatory breast cancer (IBC) or highly suspicious for IBC. The blood and     tissue samples and clinical data will be stored in a research tissue bank and used to help     researchers try to better understand IBC.   "
200752|NCT00477113|"     The Primary objective of this study is to determine the incidence and pattern of serious     infections, malignancies, and other serious adverse events (SAE) in participants with     multiple sclerosis (MS) treated with Tysabri (natalizumab).   "
200753|NCT00477126|"     To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.   "
200754|NCT00477139|"     This is a pilot study to gather preliminary data on the baseline immunologic status of     patients with HER-2(+) breast cancer and to establish an immune monitoring laboratory for     future clinical trial.   "
200755|NCT00477152|"     The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous     (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the     rehydration of pediatric patients with mild to moderate dehydration.   "
200756|NCT00477165|"     Hypotheses:        1. Primary null hypothesis: The rate of clinical response, assessed as patient-reported          global symptom rating and adequate relief of IBS symptoms, does not differ between          non-depressed IBS patients treated with the SSRI citalopram and patients treated with          placebo.        2. Secondary null hypotheses:             1. Changes in disease-related quality of life, assessed with the IBS-QOL instrument,               do not differ between patients treated with the SSRI citalopram and patients               treated with placebo.             2. Changes in rectosigmoid visceral sensitivity, assessed by barostat balloon               distention, do not differ between patients treated with the SSRI citalopram and               patients treated with placebo.   "
200757|NCT00477178|"     20 chronic pain patients using codeine are compared with 20 chronic patients not using     opioids and 20 healthy volunteers with respect to driving ability measured by     neurophysiological tests and driving in a car simulator.   "
200758|NCT00477191|"     People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and     high blood pressure than the general public. The purpose of this study is to determine how     substances produced in the fat (inflammatory markers) relate to the risk of heart disease in     people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin     resistance, increased waist size, high blood pressure, or high cholesterol.   "
200759|NCT00477204|"     The purpose of the study is to establish the safety of ezetimibe/simvastatin and simvastatin     in adolescents with Type 1 Diabetes and to determine the amount of decrease in     LDL-cholesterol.The study hypothesizes that simvastatin and ezetimibe/simvastatin will be     safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months.   "
200760|NCT00477217|"     This study will assess the safety and efficacy of zoledronic acid in patients presenting with     spontaneous osteonecrosis of the knee.   "
200790|NCT00477620|"     Purpose:      To determine whether the use of reading glasses blocks the near work mediated increased     incidence of myopia in healthy school children.      Methods:      SMART enrolled 115 emmetropic children (ages 7-9 years). The children were recruited in the     Principality of Liechtenstein. They were randomly assigned to either the control group (n=52)     or to receive reading glasses with a lens power of +2.0 dioptres (n=63). The primary outcome     measure was progression towards myopia as determined by autorefraction after cycloplegia. The     secondary outcome measure was change in biometry measurements of corneal curvature, axial     length, anterior chamber depth, crystalline lens thickness, and vitreous chamber depth using     partial coherence interferometry.   "
200761|NCT00477230|"     The purpose of the study is to compare two types of treatment for atrial fibrillation (AF)     that are designed to treat the symptoms of atrial fibrillation. The treatments being compared     are:        -  A single catheter ablation procedure with the investigational EAS, a visually-guided,          light-energy catheter        -  Standard drug therapy (antiarrhythmic drugs)      To learn more about the CardioFocus ENABLE investigational clinical study, please contact the     study site closest to you.      Eligibility Criteria      Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study     eligibility criteria include:        -  18 to 80 years of age        -  Frequent episodes of AF        -  Failed at least 1 drug treatment for AF (beta-blockers or standard AADs)        -  Other criteria   "
200762|NCT00477243|"     Primary Objectives:        1. To determine whether the degree of spirituality/religiosity as determined by the Duke          University Religion Index and Functional Assessment of Chronic Illness Therapy-Spiritual          Well Being Scale (FACIT-Sp) correlates with internal locus of control as determined by          the Locus of Control Scale.        2. To determine the relationships among spiritual-well being, religiosity, hope,          depression, and culture, socioeconomic status, and gender in a palliative care setting.        3. To determine if hope and depression in palliative care patients are affected by the          degree of intrinsic and extrinsic spirituality/religiosity.        4. To determine if patients who believe in predestination correlate with decreased locus of          control, but improved quality of life and degree of religiosity.   "
200763|NCT00477256|"     Primary Objectives:        1. To examine illness-related factors (i.e., severity of illness, quality of life rating)          as predictors or correlates of child adjustment to pediatric cancer.        2. To examine illness-related factors (i.e., severity of illness, quality of life rating)          as predictors of school reintegration (i.e., school attendance) in children with          pediatric cancer.        3. To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of          child adjustment to pediatric cancer.        4. To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of          school reintegration (i.e., school attendance).      Secondary Objectives:        1. To examine a second within-parent factor (i.e., parental perception of child          vulnerability) as a predictor or correlate of child adjustment to pediatric cancer.        2. To examine a second within-parent factor (i.e., parental perception of child          vulnerability) as a predictor or correlate of school reintegration (i.e., school          attendance) in children with pediatric cancer.        3. To develop a statistical model by which relative contributions of each predictor          variable (i.e., severity of illness, quality of life, parental stress, parental          perception of child vulnerability), as well as their interrelatedness, can be understood          in relation to child adjustment. Exploration of each variable's contribution will affect          the schematic organization of the model.        4. To examine demographic variables as covariates in the primary analyses. The variables          include: child's age, gender, grade, ethnicity, diagnosis, time since diagnosis, type          and duration of treatment, and time since school reintegration.   "
200764|NCT00477269|"     This study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in     patients with pulmonary arterial hypertension   "
200765|NCT00477282|"     The objective of this study is to assess the safety and efficacy of karenitecin versus     topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer.     Additionally, this study will assess the ability of karenitecin to extend the time to disease     progression, extend the overall survival time, and reduce the incidence and severity of     treatment related hematological toxicities in patients with advanced epithelial ovarian     cancer.   "
200766|NCT00477295|"     This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing     regime to allow optimal zonisamide or carbamazepine therapy for individual subjects.     Assessment of eligibility will take place at the Screening Visit. The subjects will be     randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1     must occur as soon as possible (and at least within 14 days) of the Screening Visit in order     to optimize subject care.   "
200767|NCT00477308|"     In HIV-NAT 013 phase I study, genotyping was performed in 95 children on dual NRTI which     showed that almost all children had resistance to NRTi. The HIV-NAT 013 phase II is a follow     up study to evaluate treatment outcome after salvage therapy and the evolution of mutations.   "
200768|NCT00477321|"     This study will evaluate the safety of a new experimental drug, IL-7, in people with HIV     infection. Animal studies have shown that IL-7 can improve the function and number of     infection-fighting cells called T lymphocytes, or T cells. If this study shows that IL-7 is     safe, additional studies will be done to see if it can improve the function or numbers of     T-cells in HIV-infected persons.      HIV-infected persons who have been receiving HAART therapy for at least 12 months before     enrolling in the study and have been stable on this treatment for at least 3 months before     enrollment may be eligible for this study.      Participants have about 10 clinic visits over 3 months. They receive three injections of     IL-7, one injection a week for 3 consecutive weeks. The injections are given as a shot under     the skin in the arm or leg. On the day of each injection, the participant stays in the clinic     for up to 8 hours or longer for observation and collection of blood samples. Three additional     visits (one every 3 months) may be scheduled.      During the study visits the following may be done:        -  Medical history, physical examination, blood tests every visit.        -  Electrocardiogram (EKG) at study days 0 (day of first dose), 1, 7 (day of second dose),          14 (day of third dose) and 21.        -  Chest x-ray study on day 21.        -  Blood sample collections at frequent intervals during the first 96 hours after the first          dose administration. A catheter (thin plastic tube) may be put into a vein in the arm          and left in place to allow several blood samples to be drawn without repeated needle          sticks.        -  Urine tests several times during the study.   "
200769|NCT00477334|"     This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment     in Black patients with recurrent genital herpes   "
200770|NCT00477347|"     To compare closed-loop anesthesia to manual administration of propofol and remifentanil     during liver transplantation   "
200771|NCT00477360|"     The primary objective of this study is to examine quality of life outcomes in patients who     have undergone a humeral surface replacement hemiarthroplasty.   "
200773|NCT00477386|"     Based on these pre-clinical data, which were generated by our group, the investigators     propose to test in a phase I/II clinical trial the following hypothesis: demethylation     induced by decitabine results in re-sensitization to platinum in recurrent ovarian cancer.      To test this hypothesis, the investigators will treat patients with recurrent ovarian cancer     platinum resistant (recurrence within 6 months from platinum therapy) or platinum-refractory     (no response to platinum) with a combination consisting of decitabine and carboplatin.      This will be an institutional open label phase I/II trial to determine the safety and the     biologic activity of the Decitabine/Carboplatin combination.      The investigators will determine whether Carboplatin can be safely combined with Decitabine,     the optimal dose schedule and the investigators will define whether at this dosage, the     regimen is biologically active (i.e. induces demethylation of target genes).      In the second part of the trial, the investigators will determine the clinical activity of     the combination in a population of patients with platinum-resistant ovarian cancer.   "
200774|NCT00477399|"     The effect of non-surgical methods for obesity treatment are not fully documented. This study     focus on the long term effect of an intensiv follow up (the Evje Model) compared to a     regular follow up.      The Evje Model is a combined model, consisting of repeated stays at a specialist centre,     telephone follow up at home, home groups, self monitoring and close contact with the     patients' local physician.   "
200775|NCT00477412|"     The goal of this clinical research study is to learn if bortezomib (in combination with     rituximab plus 2 different intensive chemotherapy regimens) can help to control the disease     in patients with mantle cell lymphoma. The safety of these drug combinations will also be     studied.   "
200776|NCT00477425|"     This is a supplemental study designed to evaluate the effect of bevacizumab on QTc interval     in cancer patients. Patients who have consented to participate in selected randomized     controlled bevacizumab clinical trials will be invited to participate in this study.   "
200777|NCT00477451|"     We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with     panic disorder. This study will provide an initial assessment of efficacy, and to continue to     describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato     Alprazolam on a doxapram-induced panic attack in patients with panic disorder.   "
200778|NCT00477464|"     This study is to evaluate the safety and efficacy of lapatinib taken together with     capecitabine in Japanese patients. The study will proceed in two phases; the first     phase(Part1) will lead to an evaluation of the mainly tolerability as well as PK parameters.     If there are no major safety concerns in Part 1, the study will move into the second phase     (Part 2) to further evaluate the safety and clinical activity.   "
200779|NCT00477477|"     This study is designed to evaluate the efficacy of two diets, a low glycemic load diet and a     low saturated fat diet, in the treatment of adolescents with some heart disease risk factors     associated with being overweight, such as high blood pressure, pre-diabetes, and cholesterol     problems. The objective of the study is to determine which diet improves these risk factors     more. The design of the study is a modified feeding study, which requests that the     participants eat all and only the food provided by the study for 8 weeks, most days per week.     Dietary counseling by phone will continue between 2 and 6 months of the study and the effects     of this maintenance period will be assessed at 6 months time.   "
200780|NCT00477490|"     The purpose of this study is to investigate the efficacy and safety of several doses of the     melt formulation of desmopressin in a broad population of adult patients with nocturia.   "
200781|NCT00477503|"     -  Primary Objective will be to evaluate the use of Ga-67 citrate as an alternative          radiopharmaceutical for CSF imaging.        -  Secondary Objective will be to evaluate the biodistribution, pharmacokinetics and          radiation dosimetry of In 111 DTPA and gallium-67 after intrathecal injection during          remission of leptomeningeal metastasis (LM) and during LM occurrence, remission and          recurrence.   "
200782|NCT00477516|"     The purpose of this study is to determine how levels of this newly-discovered hormone, called     FGF-23, changes in the blood in response to a high calcium dialysis bath during a     hemodialysis (HD) treatment, and how this relates to changes in the calcium and PTH levels.     We are also studying the effects of dialysis and inflammation on the levels of Fetuin A.      We intend to prospectively study a cohort of end stage renal disease (ESRD) patients on     hemodialysis in order to determine whether FDF-23 levels independently affect     non-suppressible PTH levels. The relationship between Fetuin A and inflammatory markers will     also be determined. By dialyzing patients on 3.5 mEq/L calcium dialysate bath, we seek any     relationship between ionized calcium, FGF-23 and PTH.   "
200783|NCT00477529|"     To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of ABI-008     given every 3 weeks; to characterize the toxicities of ABI-008; and to determine the     pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule.   "
200784|NCT00477542|"     This is a phase trial to determine the maximum tolerated dose (MTD) of clofarabine in a     combination with a myeloablative dose of busulfan. This is an initial step in developing a     novel myeloablative preparative regimen for allogeneic hematopoietic stem cell     transplantation (HSCT). While this phase I trial will initially develop the regimen in     patients with refractory disease, it is expected that it will find its best application in     patients with less advanced disease   "
200785|NCT00477555|"     The special fixation methodology of the Mosaic Ultra stented procine bioprosthesis allows     valves to maintain their natural leaflet structure and root geometry which prevents leaflet     calcification and improves hemodynamic performance and a potential for increased durability.     This study will document the hemodynamic performance, as assessed by echocardiographic     recordings, at six months post implantation.   "
200786|NCT00477568|"     The primary purpose of this study is to determine the prevalence of back pain in permanent     wheelchair users (excludes transitory users) in different regions of Spain. Another study     objective is the identification of risk factors for back pain in this population. Data     collection will be by means of a structured questionnaire which will be validated in a     previous pilot study.   "
200787|NCT00477581|"     This purpose of this study is to compare the effect of exenatide to that of sitagliptin on     2-hour postprandial glucose in subjects with type 2 diabetes mellitus.   "
200792|NCT00477646|"     RATIONALE: Women may stay up-to-date with cancer screening if a health professional helps     them overcome barriers to screening, including helping them to schedule cancer screening     appointments.      PURPOSE: This randomized clinical trial is studying the use of health professional-tailored     telephone support compared with usual care from their personal doctor to help women overcome     barriers to screening for colorectal, cervical, and breast cancer.   "
200793|NCT00477659|"     The objective of this study is to identify neural correlates of cognitive improvement after     three months of donepezil HCl in subjects with mild Alzheimer's Disease (AD), measuring the     Functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion in     the Medial Temporal Lobe network. The hypothesis is that donepezil HCl will improve MTL     connectivity and CBF Perfusion in the MTL-projected target regions, which will significantly     correlate with cognitive improvement in mild AD subjects.   "
200794|NCT00477672|"     This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103)     compared to placebo in patients with Parkinson's disease psychosis.   "
200795|NCT00477685|"     1. . Study Objective: The objective of this study is to determine the safety and          effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in          phacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the          reduction of Intraocular Pressure, and the secondary endpoint is to prove the safety via          the incidence of complications and adverse events.        2. . Study Design: The study is designed as a historical controlled study. Patient who meet          the inclusion/exclusion criteria and sign the informed consent form will be included for          this study. The allocation of subjects is non-randomized, and there is a single group          for assignment.        3. . Follow-Up: This investigation is including 7 post-operative visits and follow-up          within 6 months from the date of surgery. Patients should be seen at postoperative days          1, 7, 14, 30, 60, 90 and 180. The visit window of ± 7 days is allowed for the 30, 60, 90          and 180 day visits. The further follow-up of subject after trial is continually tracked          by the investigator.   "
200796|NCT00477711|"     The purpose of this study is to investigate whether cetuximab (Erbitux®) with cisplatin and     capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective.   "
200797|NCT00477724|"     Severe CTEPH leads to an impaired physical capacity and a restricted quality of life and poor     prognosis.      Pulmonary endarterectomy represents the best choice as therapy, when the thrombi are located     in the central pulmonary vessels and therefore can be operated. By this operation the     pulmonary artery pressure can be normalised and the patients' survival improved. Up to now,     after successful endarterectomy patients only receive anticoagulation.      Despite operation many patients remain symptomatic and are restricted in their physical     capacity. Therefore a hypothesis of this project is that most of the patients, even after     successful operation, show peripheral vascular remodelling with a ventilation-perfusion     mismatch and elevated pulmonary pressure during exercise.      In this study we aim to analyse how many patients with CTEPH after endarterectomy show     elevated pulmonary artery pressures at rest or during exercise and are limited in their     physical capacity, hemodynamics, oxygen uptake and quality of life and need further therapy.      Another aim is to examine whether exercise and respiratory therapy may improve the patients     postoperatively.      Therefore 30 patients with CTEPH > six months after endarterectomy, with ongoing restricted     exercise capacity shall be included. After baseline examination in the University hospital     Heidelberg the patients receive exercise and respiratory therapy for three weeks. The     patients will receive further examinations at the end of rehabilitation after 3 weeks and     after 15 weeks. All examinations include medical history, family history, physical     examination, ECG and echocardiography at rest and during exercise, cardiopulmonary exercise     testing, assessment of the respiratory muscle strength, the SF-36 questionnaire for quality     of life, laboratory testing and MRI.      Rehabilitation will be conducted in the clinic for rehabilitation Koenigstuhl, Heidelberg.     Participants will be randomised into two groups, a control group receiving a conventional     therapy for three weeks, in which physical exertion is to be avoided and a training group     with additional exercise and respiratory therapy.   "
200798|NCT00477737|"     In vitro studies and in vivo animal experiments have shown that halogenated volatile     anesthetics have a protective effect on the ischemic myocardium. In clinical settings     however, anesthetic preconditioning may be of more interest. The aim of our study was to     evaluate the cardioprotective effect of sevoflurane in patients undergoing off-pump coronary     artery bypass surgery. We proposed that a cardioprotective effect of sevoflurane would save     myocardial function, which we measured acceleration by esophageal Doppler and cardiac index     with bolus thermodilution methods, both during brief ischemia and reperfusion.   "
200799|NCT00477750|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, prednisone, and lenalidomide, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan and     lenalidomide when given together with prednisone and to see how well they work in treating     patients with newly diagnosed multiple myeloma.   "
200800|NCT00477763|"     To compare the performance of Oasys to Extreme H20 xtra 59 in dry eye contact lens pts who     receive Restasis in 1 eye and vehicle (Endura) in the other eye.   "
200801|NCT00477776|"     Early use of oral maxalon can hasten and improve the establishment of breastfeeding in     diabetic mothers after preterm and term deliveries.      Maxolon promotes breastfeeding by working on the central nervous system which increases the     milk producing hormone, prolactin which in turn helps to increase the milk supply for     breastfeeding. Successful early breastfeeding establishment is important for continued     breastfeeding.   "
200802|NCT00477789|"     In patients with chronic heart failure (CHF)due to dilated cardiomyopathy diastolic     dysfunction occurs frequently and is related to a poor outcome. We have previously shown that     parameters of diastolic function significantly correlate with uric acid levels, a marker of     impaired oxidative metabolism. We aimed to determine whether inhibition of xanthine oxidase     with allopurinol might affect diastolic function in patients with CHF.   "
200803|NCT00477802|"     The primary objective of this study is to determine whether intramuscular injections of     botulinum toxin type A (Botox®) in selected cervical muscles at antidystonic dosages can     reduce levodopa-induced peak-dose dyskinesias (LID) in the cervical region in adult patients     with idiopathic Parkinson's disease. It is hypothesized that the intramuscular injection of     antidystonic doses of botulinum toxin into cervical muscles will decrease the duration and     severity of LID in the cervical region in patients with Parkinson's disease (PD).   "
200834|NCT00478218|"     RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the     cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may     kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving     lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with     newly diagnosed multiple myeloma.   "
200804|NCT00477815|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal     antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry     cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy,     such as melphalan, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. A peripheral stem cell transplant using     stem cells from the patient may be able to replace blood-forming cells that were destroyed by     chemotherapy. Giving monoclonal antibody therapy together with chemotherapy and autologous     peripheral stem cell transplant may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90     ibritumomab tiuxetan when given together with rituximab, melphalan, and autologous peripheral     stem cell transplant in treating patients with previously treated multiple myeloma.   "
200805|NCT00477828|"     The purpose of this study is to determine whether treating sleep apnea with continuous     positive airway pressure would result in improvements in cognition in patients with     Alzheimer's disease.   "
200806|NCT00477841|"     To determine the response to treatment with a novel esophageal stent loaded with 125I seeds     for intraluminal brachytherapy versus a conventional covered stent in patients with advanced     esophageal cancer.   "
200807|NCT00477854|"     The purpose of this study is to test the effects of chromium picolinate on food intake, food     cravings, eating attitudes, and appetite. If chromium picolinate is found to have a     beneficial impact on satiety and food intake, then this supplement may be an alternative or     adjunctive treatment for overweight people desiring to modify their food intake. The primary     hypothesis of this study is that among individuals who report being carbohydrate cravers,     chromium picolinate supplementation will reduce food intake during a test lunch meal and     produce greater satiety in comparison to a placebo.   "
200808|NCT00477867|"     RATIONALE: Gathering information about patients with ovarian cancer over time may help     doctors learn more about a patient's use of medical services and the cost of these services.      PURPOSE: This clinical trial is collecting information about the patient's health and use of     medical resources over time in patients with stage III ovarian cancer receiving paclitaxel     and cisplatin on clinical trial GOG-172.   "
200809|NCT00477880|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them.      PURPOSE: This clinical trial is studying how well cetuximab works in treating patients with     Ménétrier disease at high risk of developing stomach cancer.   "
200810|NCT00477893|"     Spondyloarthropathies (SpA) are often diagnosed with a considerable delay (often 8-10 years     from symptom onset), because the available clinical, biochemical and radiological methods are     not sufficiently sensitive. TNF-a antagonists have recently been introduced for treatment of     SpA, and current data indicate a higher efficacy than previously available therapies. The     improved treatment options have increased the need for improved methods for diagnosis,     monitoring and prognostication of these diseases, so that the efficient therapies can be     initiated at the optimal time point and monitored optimally. Magnetic resonance imaging (MRI)     and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.   "
200811|NCT00477906|"     Previous studies suggests that M-Vax, a melanoma vaccine prepared from patients own cancer     cells, can stimulated patients' immune system to react against their cancer. AVAX has     identified a dose and schedule of administration of M-Vax that work optimally. In this study,     AVAX will determine whether M-Vax is effective in shrinkage of melanomas that have spread     (stage IV). To increase it effectiveness, M-Vax administration will be followed by     administration of low doses of interleukin-2 (IL2), a marketed drug that is known to     stimulate immunity and cause some shrinkage of melanomas. Two-thirds of patients will receive     M-Vax + IL2, and one-third will receive a placebo vaccine + IL2. The study is blinded so that     neither the patients nor their physicians know which material they are receiving.      To be eligible for this study, patients must have at least one melanoma tumor that can be     surgically removed and made into a vaccine. In addition, they must have melanoma that has     spread to to the lungs or to soft tissue sites (under the skin, on the surface of the skin,     lymph nodes). Eligible patients may have previously received one treatment (for example,     chemotherapy) for their melanoma.      Side effects of M-Vax are expected to be mild; the most common is the development of sore     pimples at the site of vaccine injections. The low dose IL2 may cause some fatigue and other     mild symptoms.      It is expected that 387 patients will be treated in this study.   "
200812|NCT00477919|"     RATIONALE: A hand held electronic tool used to monitor symptoms and assess quality of life     may improve communication between patients and their doctors and improve the ability to plan     treatment for patients with advanced cancer receiving palliative care. It is not yet known     whether symptoms are better controlled with or without use of this electronic tool.      PURPOSE: This randomized phase III trial is studying an electronic tool to see how well it     records cancer symptoms in patients with advanced cancer receiving palliative care.   "
200813|NCT00477932|"     This study will collect blood, urine, and other tissue samples from 50 patients study-wide     with Pentalogy of Cantrell and other inherited diseases that involve mutations in non-muscle     genes. Mutations in non-muscle genes have been shown to result in human defects involving     blood platelets, kidney, hearing and sight. The major objective of this protocol is to study     a variety of blood, tissue and urine samples by looking at protein, DNA, and RNA in those     collected samples.   "
200814|NCT00477945|"     This is a phase I trial to determine the maximum tolerated dose (MTD) of clofarabine in a     combination with high-dose etoposide and cyclophosphamide. This is an initial step in     developing a novel myeloablative preparative regimen for autologous hematopoietic stem cell     transplantation (ASCT). While this phase I trial will initially develop the regimen in     patients with refractory disease, it is expected that it will find its best application in     patients with less advanced disease.   "
200815|NCT00477958|"     RATIONALE: A study that assesses the ability of older patients to think, learn, remember,     make judgments, and carry out daily activities may help doctors plan treatment for older     patients with cancer.      PURPOSE: This clinical trial is studying an assessment tool in older patients with cancer.   "
200816|NCT00477971|"     RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different     ways to stop the growth of plasma cells, either by killing the cells or by stopping them from     dividing. Having an autologous stem cell transplant to replace the blood-forming cells     destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more     plasma cells are killed. By reducing the number of plasma cells, the disease may progress     more slowly. It is not yet known whether combination chemotherapy is more effective than     chemotherapy followed by an autologous stem cell transplant in treating primary systemic     amyloidosis.      PURPOSE: This randomized phase III trial is studying the side effects and how well giving     low-dose melphalan together with dexamethasone works compared with high-dose melphalan     followed by an autologous stem cell transplant in treating patients with primary systemic     amyloidosis.   "
200817|NCT00477984|"     Previous studies have shown that alcohol significantly impairs driving performance. Acute     alcohol administration also has a detrimental effect on secondary task performance during     dual-tasks. The present study will investigate the effects of five different dosages of     ethanol (0,0.2, 0,5, 0,8 and 1,0 % BAC) on performance in a driving simulator. Steering     performance and brain activity will be recorded in both single- and dual-task conditions.   "
200818|NCT00477997|"     The purpose of this study is to examine the effects of a physiological bolus of growth     hormone on insulin signaling pathways in muscle tissue in healthy lean men.   "
200819|NCT00478010|"     RATIONALE: Determining how patients makes decisions about participating in a clinical trial     may help doctors plan clinical trials in which more patients are willing to participate and     are satisfied with their decision to participate.      PURPOSE: This clinical trial is studying how patients with stage II, stage III, or stage IV     pancreatic cancer or stage III or stage IV colon cancer or rectal cancer make decisions about     participating in a clinical trial.   "
200820|NCT00478023|"     The main objective of this study is to demonstrate the efficacy and safety of multiple-dose     application of three different oral doses of CG5503 IR (tapentadol immediate release)     compared to placebo in women undergoing abdominal hysterectomy.   "
200821|NCT00478036|"     The Investigators will compare, in a randomized, prospective, masked and controlled fashion     the effect of a non-steroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred     Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure     (IOP) lowering and degree of ocular inflammation following selective laser trabeculoplasty     treatment for open angle glaucoma.   "
200822|NCT00478049|"     This is a randomized, open-label, parallel group, phase III, multicenter, regional study. The     total number of patients expected to be exposed to study procedures is approximately 150     patients will be recruited by investigational sites throughout the Asia Pacific region that     have expertise in treating patients with NSCLC.   "
200823|NCT00478062|"     RATIONALE: Vaccines made from a tumor antigen may help the body build an effective immune     response to kill tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and how well vaccine therapy     works in treating patients who have received first-line therapy for Hodgkin's lymphoma.   "
200824|NCT00478075|"     RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry     radiation directly to cancer cells and not harm normal cells. Bortezomib may stop the growth     of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood     flow to the cancer. Bortezomib may also make cancer cells more sensitive to radiation     therapy. Giving samarium Sm 153 lexidronam pentasodium together with bortezomib may kill more     cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when     given together with samarium Sm 153 lexidronam pentasodium and to see how well they work in     treating patients with relapsed or refractory multiple myeloma.   "
200825|NCT00478088|"     The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared     to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical     disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up     period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2)     revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement     in neurologic status.   "
200826|NCT00478101|"     For cancer patients with inadequate pain relief, a switch to an alternative opioid is the     preferred option for symptomatic improvement. However, multiple opioids are often     simultaneously administered for anecdotal reasons.      The present study isdesigned to assess the analgesic profiles of two different strategies in     chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the     combination of oral oxycodone and transdermal fentanyl.   "
200827|NCT00478114|"     This is the early access programme (EAP) of sorafenib in the indication of advanced renal     cell carcinoma (RCC). The study is to evaluate the efficacy and safety of sorafenib in     patients with advanced RCC.   "
200828|NCT00478127|"     In this study, we tested the hypothesis that elevated HGF is associated with insulin     resistance and cardiovascular autonomic dysfunction in type 2 diabetic patients not receiving     insulin treatment.   "
200829|NCT00478140|"     This phase II trial is studying how well trastuzumab works in treating patients with locally     advanced or metastatic gallbladder cancer or bile duct cancer that cannot be removed by     surgery. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them   "
200830|NCT00478166|"     The purpose of this study is to use fMRI techniques to explore a certain part of the brain     associated with Alzheimer's disease known as the posterior cingulate. Determining the     functionality of this brain region may help us diagnose AD more accurately, thus allowing     earlier treatment.   "
200831|NCT00478179|"     Neuropathic pain is caused by a virus commonly associated with chicken pox. This virus may     become dormant in the nervous system and later reactivate causing herpes zoster, also known     as shingles. Post-herpetic neuralgia (PHN) is a persistent pain in the area of healed skin     lesions. This study will test the safety and efficacy of treating PHN patients with the     analgesic patch, Bupivacaine TTS (Eladur™).   "
200832|NCT00478192|"     The study is designed to assess the efficacy and safety of multiple infusions of conivaptan     in subjects with euvolemic or hypervolemic hyponatremia   "
200837|NCT00478257|"     Patients treated with chemotherapy complain of poor sleep, fatigue and depression. In     addition, chemotherapy disrupts the body's internal biological clock, which may make sleep,     fatigue and depression all worse. Women with breast cancer undergoing chemotherapy are not     exposed to much bright light and this may also contribute to the disruption of their body     clock, because bright light is necessary for a strong biological clock. One of the easiest     ways to strengthen the biological clock is by increasing bright light exposure. The correct     timing of the light exposure will help the women feel more alert during the day.   "
200838|NCT00478270|"     This single arm study will assess the efficacy of loading doses of intravenous Bondronat in     reducing pain in patients with breast cancer and metastatic bone disease experiencing     moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat     on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target     sample size is <100 individuals.   "
200839|NCT00478283|"     RATIONALE: A patient's age, health, and ability to perform daily activities may affect which     treatment options are offered by doctors to older and/or frail women with breast cancer.      PURPOSE: This clinical trial is studying the views and attitudes of oncologists and     geriatricians on the use of chemotherapy and hormone therapy in treating older and/or frail     women with breast cancer.   "
200840|NCT00478296|"     Evidence has shown poor outcome for adult patients with pre-operative pulmonary hypertension     following closure of an atrial septal defect. Life-threatening pulmonary hypertensive crises     may occur in these patients when they no longer have an atrial communication to decompress     high right heart pressures. This concern has led some to advocate fenestrated patch closure     of ASDs in patients with pulmonary hypertension with the prospect of a repeated procedure in     order to close the fenestrations at a later date.   "
200841|NCT00478309|"     RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than     usual care in increasing the number of healthy participants who regularly receive screening     for colorectal cancer.      PURPOSE: This randomized clinical trial is studying the Genetic Epidemiology and Risk     Assessment program to see how well it works compared with usual care to increase colorectal     cancer screening in healthy participants.   "
200842|NCT00478322|"     Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and     tolerability as well as the effects of treatment with an investigational drug.   "
200843|NCT00478335|"     The purpose of this research study is to determine if two investigational medications will be     more effective in decreasing urine output than the currently available and routinely used     medications in patients with congenital nephrogenic diabetes insipidus (NDI).   "
200844|NCT00478348|"     The purpose of this study is to determine whether drainage after prosthetic repair of     incisional abdominal hernias increases or decreases complications such as infection, seromas     and hematomas.   "
200845|NCT00478361|"     This phase II trial is studying how well giving gemcitabine, paclitaxel, and doxorubicin     together with pegfilgrastim works in treating patients with metastatic or unresectable     bladder cancer or urinary tract cancer and kidney dysfunction. Drugs used in chemotherapy,     such as gemcitabine, paclitaxel, and doxorubicin, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Colony     stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in     bone marrow or peripheral blood and may help the immune system recover from the side effects     of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more     tumor cells. Chemotherapy drugs may have different effects in patients who have changes in     their kidney function.   "
200846|NCT00478374|"     The purpose of this study is to determine the feasibility to combine sorafenib with     transarterial chemoembolisation in patients suffering from hepatocellular carcinoma.The     hypothesis is that sorafenib may prevent the development and growth of tumoral lesions not     treated by chemoembolisation.   "
200847|NCT00478387|"     The purpose of this study is to determine what the immune response is of ovarian cancer     patients in remission, when they are given the flu vaccine. After receiving the flu vaccine,     patients will have blood drawn 5 times in 12 months to study antibody response to the flu     vaccine.   "
200848|NCT00478400|"     This study will use MRI imaging, cognitive testing and outcome questionnaires to determine     how the brain recovers and reorganizes after an injury.   "
200849|NCT00478426|"     This phase II trial studies how well sunitinib malate works in treating patients with     endometrial cancer that has come back after a period of improvement (recurrent) or has spread     to other places in the body (metastatic). Sunitinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
200850|NCT00478439|"     The study will evaluate whether taking a nutritional supplement designed to increase macular     pigment in the eye can improve a person's ability to adjust to darkness. Patients will be     assigned to take either a placebo or nutritional supplement for 8 months. Vision will be     assessed at baseline, 4 months, and 8 months.   "
200851|NCT00478452|"     This is a randomized Phase I/II study designed to assess the induction of an anti-tumor     immune response; the effect of cyclophosphamide on the vaccine; and to assess safety in     subjects with advanced ovarian cancer or primary serous peritoneal cancer given a multivalent     DC vaccine, with or without a single dose of cyclophosphamide.      Potential benefit may range from no direct benefit to the study participants to stimulation     of the subject's own immune system to attack ovarian cancer to prevent relapse.   "
200852|NCT00478465|"     The purpose of this study determine whether the drug valganciclovir has a significant and     real benefit on the central core of symptoms experienced by patients who have high titers to     EBV and HHV-6 and are experiencing long-standing fatigue and cognitive impairment (CFS).      In addition, to characterize a quantifiable biological marker in these patients that will     facilitate the identification of those likely to respond to valganciclovir and will make it     possible to assess response to treatment.   "
200965|NCT00466141|"     This study will focus on maintenance of weight loss achieved in the 2007 Shape-Up Rhode     Island(SURI)program. We plan to recruit 180 individuals who participated in SURI and lost at     least 10 pounds to take part in a 4-month weight loss maintenance program when the SURI ends.     Participants will be randomly assigned to one of three groups: Education, Increased Exercise,     or Daily Self-Weighing.   "
200854|NCT00478491|"     The purpose of this study is to investigate the organization of memory and develop future     methods for early detection of AD. Using functional magnetic resonance imaging (fMRI), we     examine the responsiveness of the brain to memory tasks, specifically focusing on regions of     the brain (the mesial temporal lobe and posterior cingulate) that are known to be involved in     early stages of Alzheimer's disease (AD). Of interest are differences in brain activation     between people with and without a family history of AD and other risk factors.   "
200855|NCT00478504|"     The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction     agent and to test the hypothesis that letrozole will generate better pregnancy rates with     fewer multiple pregnancies and higher live birth rate than the current standard agent,     clomifene citrate in anovular infertile women with polycystic ovarian syndrome.   "
200856|NCT00478517|"     The social, psychological, economic burden of Spinal trauma with deficit is great, and there     is no curative treatment.      Erythropoetin (EPO) is promising, due to its neuroprotective effects demonstrated in vitro,     in vivo in animal models and in a preliminary study including patients with stroke.      The study primary end point is to find out the maximum tolerated dose of EPO. This is based     on the occurrence of pulmonary embolism during a 14 day delay following EPO injection.     Secondary end points include comparisons of EPO kinetics in blood and cerebrospinal fluid     (CSF), study of EPO effects on several inflammatory and apoptotic bio markers and blood cell     counts.      The experimental design is a dose scale study (600 to 2400 UI/Kg), using a single dose of     rHuEPO, (EPREX®). The EPO dose is defined using a Bayesian continuous reassessment Method     (CRM). The sample size is expected for less than 20 patients.      Eligible patients are patients aged 15 to 65 years, able to receive the EPO injection within     12 hours of a spinal trauma, without vital blood loss or associated diseases. The follow-up     lasts 6 months.   "
200857|NCT00478530|"     To evaluate the scotopic and photopic ERG responses before and after one month of     intravitreal avastin injection in patients with choroidal neovascularization.      A positive finding that will reveal a toxic effect of intravitreal avastin injection on any     component of the retina will have a significant important clinical impact regarding the     decision whether the benefit of avastin treatment for CNV will prevail over toxic effect.   "
200858|NCT00478543|"     The purpose of this study is to verify the efficacy of diuretic therapy on blood pressure     control and left ventricular mass in patients affected by chronic kidney disease   "
200859|NCT00478556|"     Patients who are scheduled by their health care provider for routine computed tomography (CT)     scan will be asked to participate in this study. The primary purpose is to determine if there     is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for     abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference     in bowel opacification for the two agents.   "
200860|NCT00478569|"     The primary objective is:      1) to describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment     when prescribed in a normal clinical setting.      The secondary objectives are:        1. to describe the demographics and clinical characteristics of the patients that in a          normal clinical setting are started on a treatment regimen with PTH(1-84)        2. to describe (using available data) the long term treatment effectiveness during the 24          months following initiation of PTH(1-84) treatment in a normal clinical setting        3. to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient          in a normal clinical setting.   "
200861|NCT00478582|"     The clinical evaluation of anemia is usually done by examination of the palpebral conjontivae     coloration. This appreciation remains crude and largely observer dependent, as no reference     scale was successfully proposed,. A Hb visual scale allowing the assessment of the degree of     clinical anemia has been developed. Its use has been validated so far in small patient groups     in the following settings: blood donation, cardiac surgery, oncology and consultation of     general practitioners.      The objective of the present investigation is to validate the use of a Hb visual scale for     the clinical evaluation of anemia in patients with kidney disease patients   "
200862|NCT00478595|"     The primary objective of this study is to assess the efficacy of Rimonabant (SR141716)     compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in     obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic     drug (sulfonylurea or α-glucosidase inhibitor).      The secondary objectives are:        -  To evaluate the effect of Rimonabant compared to placebo on other parameters related to          the glucose control, waist circumference, Body Mass Index and metabolic parameters;        -  To evaluate the safety and tolerability of Rimonabant compared to placebo;        -  To evaluate the pharmacokinetics of Rimonabant.   "
200863|NCT00478608|"     Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed     acute rejection episode at 6 months after transplantation in Korean renal transplantation     recipients.      Secondary :        1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal          transplantation recipients.        2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after          transplantation, and to investigate the incidence of biopsy-confirmed acute rejection          episode at 12 months after transplantation.   "
200864|NCT00478621|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the     uterus or womb). This infection may go away by itself, but if it does not go away (this is     called persistent infection), it can lead in women over a long period of time to cancer of     the cervix. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic     types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also     evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals'     HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control     vaccine. There will be different levels of blinding in the study.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
200865|NCT00478634|"     This study will assess the safety of RAD001 when given together with cetuximab and irinotecan   "
200991|NCT00471848|"     To assess the tolerability and effectiveness of rabbit antithymocyte globulin (ATG,     Thymoglobuline) with ciclosporin in the first line treatment of patients with acquired severe     aplastic anaemia, and patients with non-severe aplastic anaemia and who are transfusion     dependent.   "
200866|NCT00478647|"     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme     glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside     accumulates within macrophages leading to cellular engorgement, organomegaly, and organ     system dysfunction. The purpose of this study is to evaluate the safety and efficacy of every     other week dosing of GA-GCB (velaglucerase alfa) in participants with type 1 Gaucher disease     who were previously treated with imiglucerase.   "
200867|NCT00478660|"     Due to the rigor of the clinical development program of adalimumab for the indication of AS,     the population of subjects with active AS that could enroll in previous phase 3 studies was     limited. Therefore, it is necessary to further evaluate the use of adalimumab in a setting     that mimics day-to-day clinical practice to obtain further safety and efficacy data by     allowing subjects meeting the characteristics noted below to enter this study:        -  Subjects who failed another TNF inhibitor (etanercept, infliximab)        -  Subjects with advanced spinal ankylosis        -  Subjects with AS associated disorders (i.e., uveitis, IBD, and psoriasis)   "
200868|NCT00478673|"     The primary objective of the SONOMA Registry is to confirm the safety of the NexStent®     Carotid Stent System and FilterWire EZ™ Embolic Protection System in routine clinical     practice and to identify rare or unanticipated device-related events that might occur.   "
200869|NCT00478686|"     The goal of this laboratory research study is to identify possible differences in a gene     among patients with breast cancer that cannot be treated by surgery. Researchers want to find     out if differences in this gene may increase the risk of side effects from capecitabine.   "
200870|NCT00478699|"     Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely     Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.   "
200871|NCT00478712|"     Hirschsprung disease is a genetic condition caused by lack of nerve cells in varying lengths     of the intestines. This study will investigate the complex genetic basis of the disease,     which involves multiple interacting genetic factors.   "
200872|NCT00478725|"     To study the absorption, distribution, metabolism and excretion of GW786034, and the     absorption of a single IV dose of GW786034   "
200873|NCT00478738|"     GSK961081 has previously been administered to healthy subjects in a nebulised formulation and     the first part of this study which will be conducted in healthy subjects proposes to bridge     the change from nebulised to DPI formulation of GSK961081 before administration to patients.     The second part of the study will be conducted in COPD patients and aims to assess the safety     and bronchodilator profile of GSK961081 over 24 hours, during 14 days dosing.   "
200874|NCT00478751|"     -  Determine the impact and the threshold of long wavelength UVA and visible light on          immediate and delayed pigment production of melanocompetent individuals.        -  The study basically wants to understand what types of light make us tan.   "
200875|NCT00478764|"     The use of one dose of an antibiotic and steroid injected into the eye at the end of cataract     surgery is as safe and effective as the post operative use of eyedrops after cataract     surgery.   "
200876|NCT00478777|"     This was a multicenter, open-label, single-arm phase 3B study of the combination lenalidomide     plus pulse high-dose dexamethasone.      This study (CC-5013-MM-019) was set up and executed primarily as an expanded access program     in Germany.      Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 (baseline) with     the exception of hematology assessments that were to be performed within 14 days prior to     Cycle 1 Day 1. Randomization, blinding, and stratification were not applied in this     open-label single-arm study.      Eligible subjects given open-label treatment and received treatment with lenalidomide plus     high-dose dexamethasone in 28-day cycles.      Lenalidomide (hard capsules) was to be administered orally (PO) at a dose of 25 mg daily (QD)     for the first 21 days of each 28-day cycle. According to the protocol, accrual of subjects to     the study was to be terminated within 2 months of commercial availability of lenalidomide for     this indication in Germany.      Upon discontinuation from study, minimal information was collected in order to identify when     disease progressed.   "
200877|NCT00478790|"     The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix are     effective and safe to implant as an aid of glaucoma surgery and pterygium excision surgery.   "
200878|NCT00478803|"     The primary objective of the CAVIAAR study is to prove that aortic valve sparing for patients     with aortic root aneurysms and/or dystrophic aortic insufficiency is associated with a 45%     increase of 3 years-survival rate without increased mortality or serious increased morbidity     events when compared to mechanical valve replacement.      The main hypothesis of this study is that a standardized procedure of valve sparing based on     external aortic annuloplasty in patients with dystrophic aortic insufficiency and/or aortic     root aneurysm increases survival rate without increased mortality or serious increased     morbidity events when compared with patients undergoing mechanical aortic valve replacement.   "
200879|NCT00478816|"     Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population     (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects   "
200880|NCT00478829|"     Objectives: Primary: To estimate the prevalence of depression and/or anxiety disorder in     outpatients attending the general health care settings in China.      Secondary:        -  To estimate gender- and age-specific prevalence of depression and/or anxiety disorder in          outpatients attending the general health care settings in China.        -  To estimate the prevalence of depression and/or anxiety disorder in outpatients          attending the general health care settings such as departments of neurology,          gastroenterology, cardiology, and gynecology.        -  To describe the recognition and treatment rate by treating physicians as depression          and/or anxiety for outpatients in the general health care settings in China.   "
200881|NCT00478842|"     The aim of this study is to evaluate the efficacy and safety of bilateral pallidal     stimulation in patients with a severe form of Gilles de la Tourette syndrome.   "
200882|NCT00478855|"     1. To determine the value of using piperacillin/tazobactam in reducing the cases of          extended spectrum beta lactamases (ESBL) producing E. coli or K. pneumoniae colonization          and infection.        2. To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both          pre-and post-intervention in the selected medical centers.   "
200884|NCT00478881|"     The purpose of this study is to assess if the study drug, Vardenafil (approved by Health     Authorities is available on the market for treatment of erectile dysfunction) has an effect     on bladder function and micturition frequency. The study drug is to be taken in the form of     tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active     treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug     works better than no drug. The timing of visits for the study is as follows: the 1st visit     (screening visit) at beginning of run-in-assessment with qualifying tests for patients:     electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a     non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit     (randomization visit). During visit this should be performed: urodynamic measurements     (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit     (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final     visit)-following test should be done: urodynamic measurements (filling cystometry and     pressure flow investigations), ECG, safety laboratory and residual urine (by     ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.   "
200885|NCT00478894|"     In this study we will examine patients who have undergone unilateral ACL reconstruction     surgery to determine which structural and functional characteristics of the knee two and ten     years post reconstruction surgery, aspects of the original injury and repair, and patient     characteristics are risk factors for osteoarthritis after ACL reconstruction surgery.   "
200886|NCT00478907|"     This study was designed to investigate pre-operatively measured parameters of various     anaesthetic regimes, iris color, sex, age, surgical time, severity of Marcus-Gunn Pupil     (MGP), type of mechanical stimulation of eye, and number of extraocular muscle (EOM) under     tension as predictors of significant OCR in pediatric strabismus surgery.   "
200887|NCT00478933|"     To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify     patients at risk of ventricular tachycardia.      To evaluate the influence of ICD-based diagnostic information on the long term treatment and     management of primary prevention ICD-patients.   "
200888|NCT00478946|"     Colorectal cancer is a type of cancer that begins in the large intestine (colon) or the     rectum (end of the colon). Several drugs are often given in combination to treat colorectal     cancer. One of the most active treatment combinations is known as FOLFOX, which is a     combination of 5-fluorouracil (5-FU), leucovorin, and oxaliplatin. Oxaliplatin is a type of     platinum drug and was approved by the FDA in 2004. While generally well-tolerated,     oxaliplatin may cause toxicity to the nerves, such as sensory loss or cold sensitivity.      Picoplatin is a new type of platinum drug that has shown activity with 5-FU in pre-clinical     studies and has undergone extensive Phase 1 and Phase 2 testing in a variety of cancers. No     significant nerve toxicity has been seen in previous studies of picoplatin.      This study will review the safety and effectiveness of FOLPI, which is the combination of     5-FU and leucovorin with picoplatin in participants with colorectal cancer.   "
200889|NCT00478959|"     This is a single-arm, open-label Phase II study evaluating the activity of Lenalidomide in     patients with relapsed or refractory Hodgkin's lymphoma.   "
200890|NCT00478972|"     The primary objective of this study is to assess the efficacy of Rimonabant (SR141716)     compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in     obese type 2 diabetic patients inadequately controlled with diet and exercise alone.      The secondary objectives are:        -  To evaluate the effect of Rimonabant compared to placebo on other parameters related to          the glucose control, waist circumference, Body Mass Index and metabolic parameters;        -  To evaluate the safety and tolerability of Rimonabant compared to placebo;        -  To evaluate the pharmacokinetics of Rimonabant.   "
200891|NCT00478985|"     The first purpose of this study is to evaluate the persistence of the complete molecular     remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment     (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for     bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors     associated with the persistent complete molecular remission.   "
200892|NCT00478998|"     The purpose of this study is to see whether patients undergoing ESWL, for upper tract urinary     stones between 1.5-2.0cm, may be treated by expulsion therapy(Tamsulosin) instead of     inserting ureteral stents .   "
200893|NCT00479011|"     Hypovolaemia and tissue hypoperfusion can pass undetected during and after major surgery. The     resulting systemic inflammatory response and organ dysfunction, often not clinically apparent     for several days, may lead to increased morbidity and mortality and prolonged hospital stay.      In this regard, intraoperative optimization of circulatory status by volume loading has been     shown to improve the outcome of patients undergoing high-risk surgery.      Indeed, several reports (1-7) have shown that monitoring and maximizing stroke volume by     volume loading (until stroke volume reaches a plateau, actually the plateau of the     Frank-Starling curve) during high-risk surgery decreases the incidence of post-operative     complications and the length of hospital stay.      Unfortunately, this strategy has required so far the measurement of stroke volume by a     cardiac output monitor, as well as a specific training period for the operators (8), and     hence is not applicable in many institutions as well as in many countries.      The arterial pulse pressure variation (∆PP) induced by mechanical ventilation is known to be     a very accurate predictor of fluid responsiveness, i.e. of the position on the preload/stroke     volume relationship (Frank-Starling curve) (9).      By increasing cardiac preload, volume loading induces a rightward shift on the preload/stroke     volume relationship and hence a decrease in ∆PP. Patients who have reached the plateau of the     Frank-Starling relationship can be identified as patients in whom ∆PP is low (9).      Therefore, the clinical and intraoperative goal of “maximizing stroke volume by volume     loading” can be achieved simply by minimizing ∆PP.      We designed the present study to investigate whether monitoring and minimizing ∆PP by volume     loading during high-risk surgery may improve post-operative outcome and decrease the duration     of post-operative hospital stay.   "
200894|NCT00479024|"     To determine comparative 1-year outcomes in renally impaired patients who previously     underwent cardiac angiography with Isovue®-370 or Visipaque™ 320 as part of the IOP-104 trial     protocol and were evaluable for determination of post-contrast significant renal injury     (defined as >25% increase in SCr or >25% increase in cystatin C).   "
200895|NCT00479037|"     The primary objective of this trial is to show that PTH(1-84) is superior to strontium     ranelate in bone formation measured as changes in bone formation markers over a treatment     period of 24 weeks in postmenopausal women with primary osteoporosis.   "
200896|NCT00479050|"     Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma     greater than 3 cm,the ablation volume of coagulation necrosis can be significantly     increased,which may be enable effective treatment of patients with HCC greater than 3 cm.   "
200897|NCT00479063|"     In this case-control study, cases were chronic LBP patients aged 30-50 in whom a lumbar MRI     had been prescribed. Controls were subjects aged 30-50 in whom a cranial MRI had been     prescribed for headache, who did not suffer from LBP and had no history of clinically     relevant LBP. Two hundred and forty cases and 64 controls were recruited consecutively in     Radiology services across six cities in Spain. Imaging findings and subjects' characteristics     were gathered through previously validated instruments. Radiologists who interpreted MRIs     were blinded to subjects' characteristics. A multivariate logistic regression model was     developed to assess the association of Modic changes with LBP, adjusting for sex, age,     body-mass index, lifetime exposure to smoking, physical activity, and disk degeneration.   "
200898|NCT00479076|"     The primary objective of this study is to determine the recommended phase II dose of AVE0005     in combination with S-1 in Japanese cancer patients.      The secondary objectives of this study are to assess the safety profile of AVE0005, to     determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor     effects.   "
200899|NCT00479089|"     Primary Objective:      1. To compare the proportion of patients free from progression 9 months from the start of     consolidation therapy with the combination of docetaxel and ZD1839 (Iressa) versus docetaxel     alone. For the purposes of this protocol, consolidation therapy refers to treatment given     at the time of maximal benefit from conventional front-line multi-agent chemotherapy.      Secondary Objective:      1. To compare time to progression (TTP), overall survival (OS) and cause-specific survival     (CSS) in the two arms. For completeness, these will be reported both from the initiation of     consolidation chemotherapy, and from the completion of induction chemotherapy.   "
200900|NCT00479102|"     Healthy babies(age 8-18 months) following a routine blood count, with no anemia or iron     deficiency, will be randomly placed in two groups. Group 1 will receive a 3 months preventive     dose of an iron preparation (Ferripel 3 iron polysaccharide complex). Group 2 will be     followed up as a control group. Following a nutritional questionnair, parents of all babies     will receive instruction regarding appropriate nutrition in the 2nd year of life. A follow-up     blood count will be taken from all participating babies 3 months after recruitment. The study     aims to evaluate effectiveness of iron supplementation in the 2nd year of life. The     hypothesis is that babies who receive iron supplementation in the 2nd year of life are less     likely to develop iron deficiency or anemia.   "
200901|NCT00479115|"     The purpose of this research study is to determine whether an experimental drug called     AMD3100 used in combination with another medication called G-CSF is safe and can help to     increase the amount of blood stem cells (called CD34+ stem cells) found in the peripheral     blood of patients with Fanconi anemia. While AMD3100 has been used successfully in adult     volunteers and cancer patients, it has not been used in children or patients with Fanconi     anemia and in only a few children with cancer.      Fanconi anemia is a rare genetic disease. Most Fanconi anemia patients eventually develop     bone marrow failure, a condition in which the bone marrow no longer produces red blood cells     (to carry oxygen), white blood cells (to fight infection), and platelets (to help blood     clot). The only successful treatment for patients with Fanconi anemia with bone marrow     failure is bone marrow transplantation. However, this treatment has many risks and is not     available to all patients with Fanconi anemia.      CD34+ cells include stem cells found in the bone marrow or peripheral blood which are capable     of making the red blood cells, white blood cells, and platelets. CD34+ stem cells can be     collected from bone marrow or peripheral blood and purified using an experimental device     called the CliniMACS. However, most Fanconi anemia patients do not have enough CD34+ stem     cells in their bone marrow or peripheral blood to be collected using standard methods that     work well in children and adults who don't have Fanconi anemia.   "
200902|NCT00479128|"     The goal of this clinical research study is to find the highest tolerable dose of Gemzar®     (gemcitabine) and Adriamycin® (doxorubicin) that can be given together with Velcade®     (bortezomib) in patients with urothelial cancer or other solid tumors.   "
200903|NCT00479141|"     The HIV epidemic in China has reached a phase of exponential growth; the number of new     infections has been steadily increasing over the past decade. The purpose of this study is to     evaluate the effectiveness of a Combined Individual- and Community-Based Behavioral     Intervention to Improve Quality of Life for HIV-Positive Villagers and decrease HIV related     stigma in Rural China.   "
200904|NCT00479154|"     This study will test whether botulinum toxin (Botox) may relieve the uncomfortable sensations     patients with restless legs syndrome (RLS) experience. RLS is a common movement disorder that     causes sensory discomfort and restlessness, most often in the legs, which improves with     movement. Although medications are available to treat the disorder, many people experience     side effects that prevent them from continuing on the medication. The Food and Drug     Administration has approved Botox for other movement disorders and for some cosmetic uses.      People 18 years of age or older with moderate to severe RLS who have been taking RLS     medications for more than 6 weeks before entering the study may be eligible to participate.     Candidates are screened with a medical history, physical and neurological examinations, blood     tests and, for women who can become pregnant, a urine pregnancy test.      Participants are randomly assigned to receive injections of either Botox or placebo (salt     water) into up to nine areas of the legs. The correct location of the muscles to be injected     is determined by electromyography (EMG), a test that measures the electrical activity of     muscles. For surface EMG, electrodes (small metal disks) are filled with a conductive gel and     taped to the skin. Needle EMG involves inserting a needle into a muscle. Both methods are     used in this study.      At 2 and 4 weeks after the injections, subjects are interviewed by telephone and asked to     describe their symptoms, side effects and any improvement they may have noticed. After 12     weeks they return to NIH for injections with the alternate compound; that is, those who     received Botox previously are given placebo for the second set of injections, and vice-versa.     Subjects are again contacted by telephone 2 and 4 weeks after the injections to report their     symptoms, side effects and benefits.   "
200905|NCT00479167|"     The purpose of this study is to determine what dose of bortezomib in combination with     tositumomab I-131 is tolerable whether bortezomib and Tositumomab I-131 are effective in the     treatment of relapsed or refractory non-hodgkin's lymphoma (NHL). Both agents are effective     in treating relapsed and refractory NHL. Administer of the agents together may sensitize the     cells to the radiation from Tositumomab I-131.   "
200906|NCT00479180|"     Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation     of an AV graft or fistula for hemodialysis access.   "
200961|NCT00466089|"     A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and     erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung     cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile,     and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D     Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.   "
200907|NCT00479193|"     Patients will be screened at the initial visit to the burn center. If the patients are     eligible according to the inclusion/exclusion criteria, consent for the study will be     obtained. One of the investigators will identify two sites that appear to be the same depth     on each patient [1 site Polymen and 1 site bacitracin/xeroform )]. The depth of injury will     be verified as partial thickness using laser doppler. Each site will be at least 4cm x 4cm in     size. One site will be identified for bacitracin/xeroform and one site for Polymen. All burns     will be initially debrided and cleaned according to burn unit protocol. The dressing will     then be applied. All dressings will be covered with cotton gauze and ace wraps. Laser Doppler     will be utilized to determine burn depth at both the trial and control sites. On each     subsequent visit, patients will rate the pain of the dressing change on a 1-10 pain intensity     scale. It will be noted if the wound appears infected or if antibiotics are prescribed.      The study will end for each patient when the investigator determines that 95% of their burn     has re-epithelized.   "
200908|NCT00479206|"     The principal aim of this project is to investigate reports of developing artemisinin     resistance in Cambodia using an integrated in vivo - in vitro approach to examine recent     alarming reports of treatment failures with advanced combination therapies along the     Thai-Cambodian border, which could have major impact on the malaria situation in the affected     areas as well as the rest of the malaria-endemic world.   "
200909|NCT00479219|"     To assess the pharmacodynamics (PD) of biomarkers amyloid beta peptide 40 and 42 (Ab40 and     Ab42) in CSF, following single oral doses of GSI-953, an investigational drug, in healthy     young subjects and patients with Alzheimer Disease (AD).   "
200910|NCT00479232|"     This study is to evaluate the safety and tolerability of vorinostat in combination with     decitabine as well as the in vivo molecular and biological effects of vorinostat in patients     with refractory or relapsed Acute Myelogenous Leukemia (AML) and intermediate or high risk as     defined by International Prognostic Scoring System (IPSS) Myelodysplastic Syndrome (MDS).     Participants with Acute Myelogenous Leukemia or Myelodysplastic Syndrome are eligible.   "
200911|NCT00479245|"     The main purpose of this study is to determine the measurement characteristics of WHODAS-II     (World Health Organization Disability Assessment Schedule), as well as to analyze its     correlation with low back pain (Visual Analog Scale, VAS), disability (Spanish version of the     Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of     the FAB Questionnaire, FABQ) and quality of life (SF-12). Measurements will be taken at     baseline and 6 days later (day 7).   "
200912|NCT00479258|"     To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in     subjects ages 6-17 over a 1 year period.   "
200913|NCT00479271|"     The aim of this trial was to apply a home based, flexible, stepped-care intervention designed     to improve the awareness and knowledge of family caregivers regarding dementia, to maximise     their caregiving resources and to improve their caregiving skills. A Randomized Controlled     Trial (RCT) will be used to evaluate the same wherein the intervention group will get the     services immediately and the control arm would receive the same after a period of 6 months.   "
200914|NCT00479284|"     Patients with chronic hypercapnic respiratory failure can be successfully treated with home     nocturnal non-invasive ventilation. Bi-level pressure support ventilators are at present the     most frequently used ventilators for long term home ventilation. A recently commercialized     bi-level ventilator offers the feature of automatically adjusting pressure support on the     basis of a pre-determined ideal effective ventilation. Because this option may induce     important swings in pressure support, and thus patient discomfort, and maybe increase leaks,     we chose to analyse the impact of average volume assured pressure support (AVAPS) on patient     comfort, subjective and objective quality of sleep and efficacy of ventilatory support.   "
200915|NCT00479297|"     To assess the safety and tolerability of ascending single oral doses of SAM-531, an     investigational drug, in healthy Japanese male subjects. Secondary: To obtain preliminary     pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531 in healthy Japanese male     subjects.   "
200916|NCT00479310|"     A Multi-center, Randomized, Vehicle Controlled, Double Blind Clinical Trial to Evaluate the     Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the treatment of     Head Lice.   "
200917|NCT00479323|"     Serum 89 SF is a supply of serum that was collected from people who were vaccinated with the     pneumococcal vaccine in the late 1980s. The supply of this serum is running low. The purpose     of this study is to give the pneumococcal vaccine to healthy volunteers and take serum blood     samples in order to increase the reference serum supply. Study participants will include 250     healthy men and women, ages 18-45. Study procedures will include a physical exam, interviews,     blood samples and blood testing. All volunteers will receive the pneumococcal vaccine in the     deltoid muscle of the arm. Participants will be involved in the study for approximately 17     weeks.   "
200918|NCT00479336|"     To investigate the dose response for changes from baseline in body weight as a primary     endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb     edema, and pleural effusion as secondary endpoints in seven-day repeated oral administration     of OPC-41061 at 7.5, 15, and 30 mg/day or placebo in cirrhosis patients with ascites despite     taking conventional diuretics.   "
200919|NCT00479349|"     To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an     investigational drug, in healthy Japanese young male and elderly subjects.To provide the     pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in     healthy Japanese young male and elderly subjects.   "
200920|NCT00465556|"     DOVE Home Visit Program is a brochure based intervention delivery by public health nurses     which aims to prevent and reduce intimate partner violence against pregnant and postpartum     women and their infants.      The purpose of the study is to test the effect of home visits on reducing domestic violence     and improving the lives of pregnant women and their children.   "
200921|NCT00465569|"     The purpose of this study is to determine if small oral doses of milk protein are safe and     effective in decreasing sensitivity to cow's milk in allergic children.   "
200922|NCT00465582|"     Our main objectives are to evaluate the importance of meningococcal carriage and to determine     the predisposing factors   "
200962|NCT00466102|"     The purpose of this study is to determine wether RAD001 can inhibit growth of tumour cells     and/or stop the formation and activity of bone degrading osteoclasts.   "
200924|NCT00465608|"     Problem and Objectives: There is currently no pharmacological treatment for curing post     traumatic stress disorder (PTSD). The investigators will test whether propranolol when given     immediately after trauma evocation is able to decrease the strength of the traumatic memory,     and by extension, the severity of PTSD symptoms associated with that memory.      Hypotheses:        1. The subjects will show a significant pre/post decrease in PTSD symptoms.        2. Those gains will be maintained at follow-up.      Study Design: Open pharmacological trial.      Method: On the first visit (V1), the subjects will describe their traumatic experience in     writing and will receive the propranolol. A script describing this experience will be     constructed to be used in the subsequent encounters to elicit the trauma memory. A week later     (V2), before receiving the propranolol, subjects will be asked to read aloud their trauma     script while imagining it as vividly as possible for 10 minutes. This weekly treatment will     be repeated 6 times (from V1 to V6). A total of 6 doses of propranolol will be given. A     self-report measure will be used to monitor improvement in PTSD symptomatology on the     following visits: V1, V4, V6, V7 and V8 (3 month follow-up).      Statistical Analyses: A repeated measure ANOVA (pre-test, post-test, and 3-month follow-up)     using the PTSD symptom score will be conducted.. Three t-tests will be performed to examine     simple effects. The alpha level will be set at p = .05 (two-tailed). Fisher's exact test will     be used to examine whether Ss still meet the diagnostic criteria for PTSD at the end of the     study.      Clinical Implications: If this treatment is effective, a randomized controlled trial will be     launched. This treatment has the potential to become the first pharmacological treatment     designed to cure PTSD.   "
200925|NCT00465621|"     The purpose of thie study is to compare the safety and IOP-lowering efficacy of AL-37807     Ophthalmic Solution 0.05%, 0.1% and 0.2% dosed QD AM to Xalatan dosed QD PM and Vehicle in     patients with open-angle glaucoma or ocular hypertension   "
200926|NCT00465634|"     To assess the role of uterine artery and maternal serum leptin and lipids and their     combination in screening for pre-eclampsia and small-for-gestational-age (SGA) fetuses at     20-24 weeks of gestation   "
200927|NCT00465647|"     The primary objective of this study is to characterize the pharmacokinetics and     pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16     years inclusive. The secondary objectives are to characterize the safety and efficacy of     hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.   "
200928|NCT00465660|"     Female subjects over the age of 40 will be recruited and randomised into a progressive     resistance training (PRT) or sham-exercise group. The PRT group will train at 80% of their     peak strength, using Keiser pneumatic resistance machines, and progress approximately 3% per     session. Strength will be re-assessed fortnightly. Exercises will target muscles around the     hip and knee. The sham-exercise group will train on the same equipment as the PRT group     except hip adduction, but without added resistance or progression. Both groups will train 3     days per week for roughly 45 minutes for 6 months.      It is hypothesised that high intensity PRT will decelerate the tibial and femoral cartilage     degeneration in the knee affected most by OA.      Primary Outcome:      Articular cartilage morphology following 6 months high intensity progressive resistance     training      Secondary Outcomes:      Muscle and fat cross-sectional area (CSA) (pre and post) Muscle strength, power, endurance,     and contraction velocity (pre, 3 months, & post) Medications (pre, 3 months, & post) Body     composition (pre, 3 months, & post) Balance; Physical function (pre, 3 months, & post)     Questionnaires (pre, 3 months, & post)        -  Habitual exercise (PASE) -WOMAC index (pain, stiffness and functional ability)        -  Depressive symptoms (Depression Scale) -Quality of life (SF36)        -  Confidence performing physical activity (Ewart) -Demographics   "
200929|NCT00465673|"     Primary objective:      To determine the brain response rate of Lipo-Dox in breast cancer patients with brain     metastasis      Secondary objectives:        1. To determine the overall objective response rate (ORR)        2. To determine the progression free survival, and duration of objective response        3. To evaluate the overall survival (OS)        4. To assess the safety profiles   "
200930|NCT00465686|"     The purpose of this pilot study is to gather the data needed to do a larger research study to     determine whether children with cerebral palsy print better sitting at an     ergonomically-designed, custom-fitted school desk or at an oversized, standard school desk.   "
200931|NCT00465699|"     This study is being done to see in B12 applied to the skin will improve the symptoms of     eczema in children compared to a placebo creme   "
200932|NCT00465712|"     The aim of the study is to evaluate the effect of transabdominal amnioinfusion before second     external cephalic version after initial failure.Patient with a single foetus, at term, in     breech presentation and after a first cephalic version are included. The randomisation     determines whether the patient is included in the group with amnioinfusion before second     cephalic version or with usual second cephalic version only; The efficacy's evaluation is     based on rate of cephalic presentation at birth.Success rate of cephalic version with or     without transabdominal amnioinfusion, rates of cesarian section in the two groups,maternal     and fetal morbidity, time between second cephalic version and birth will be studied.      Prospective interventional randomized sequential comparative multicentric study. A maximum of     240 patients will be included (120 in each group). As the study is sequential it will be over     as soon as a significative difference is shown.   "
200933|NCT00465725|"     Picoplatin is a new platinum-based chemotherapy drug that has been studied in a variety of     cancers. Phase 1 and 2 studies have demonstrated that picoplatin may be effective in patients     whose cancer returns or does not improve after treatment with chemotherapy. In these studies,     picoplatin was administered intravenously. A capsule containing picoplatin has been     formulated. This study will investigate the activity of the oral capsule in humans.     Participants with advanced solid tumors will be enrolled.   "
200934|NCT00465738|"     This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the     treatment of arm tightness (upper limb spasticity) using two different dilutions of     incobotulinumtoxinA (Xeomin).   "
200935|NCT00465751|"     The purpose of this study is to determine whether chenodeoxycholic acid decreases de novo     hepatic lipogenesis, hepatic fat content, hepatic triglyceride production and plasma     triglyceride concentrations and improves hepatic glucose metabolism in patients with the     metabolic syndrome, Familial Hypertriglyceridemia and Familial Combined Hyperlipidemia.   "
200938|NCT00465790|"     The main goal of the GENEPARK consortium is to employ innovative haemogenomic approaches to     determine gene expression profiles specific for genetic and idiopathic Parkinson's disease     (PD) patients. These gene expression signatures will be utilised clinically as non-invasive     diagnostic tests for PD. The sensitivity of the newly developed diagnostic test will be     determined by extensive validations on an independent cohort of PD patients, whereas the     specificity will be assessed by testing patients with atypical parkinsonisms, including     multiple system atrophy, progressive supranuclear palsy and diffuse Lewy body disease. In     order to test the specificity of the diagnostic set in other disorders that affect basal     ganglia, Huntington's disease and dopa responsive dystonia patients will be analysed. The     second objective of the proposal is to determine correlations between gene expression     signatures and different stages of PD and thus provide the basis for early diagnosis and     monitoring of disease progression. These changes in blood gene expression will be correlated     with alterations detected by neuroimaging in the brain of PD patients. Such combinations of     molecular and morphological markers of disease may ultimately facilitate the selection and     monitoring of neuroprotective therapies for PD. Finally, GENEPARK aims to develop new     bioinformatic software tools for selection of genomic biomarkers using microarray data. A set     of established computational tools will be applied and novel methods, some of them based on     mechanistic modelling of the neurodegenerative diseases, will be developed in order to study     the advantages and limitations of the different methodologies.      With special emphasis on the careful clinical selection of patients and sufficient power     regarding patient numbers, as well as extensive quality control and validation of the data,     GENEPARK aims to develop a standardised approach to development and validation of     haemogenomic biomarkers of disease.   "
200939|NCT00465803|"     The purpose of this study is to assess patient compliance with DuoTrav versus concomitant     administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular     hypertension.   "
200940|NCT00465816|"     This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine     134612 when given in an experimental co-administration versus vaccine 134612 alone and versus     the experimental co-administration alone in healthy subjects aged 11 through 17 years. There     will be 3 groups in this study.   "
200941|NCT00465829|"     The primary objective of LABS-2 is to use standardized techniques and measures to assess the     longer-term safety and efficacy of bariatric surgery by:        1. comparing post-surgical outcomes to pre-operative status        2. examining risks and benefits of surgery.      LABS-2 will determine the associations between clinical/demographic patient characteristics,     components of the surgical procedure, and peri-operative and post-operative care with     post-operative risks and changes in patient status.      Funds are not available to pay for the surgery for patients, only to address research     questions.   "
200942|NCT00465842|"     Hepatocellular carcinoma (HCC) is the fifth commonest cancer in the world with poor     prognosis, as the annual mortality is almost equivalent to the incidence. This is mainly due     to late diagnosis and co-morbid liver dysfunction. HCC is prevalent in our region than in the     West due to prevalent Hepatitis B infection and carriers. At the time of diagnosis, only 10 -     20% of HCC patients are candidates for liver resection or transplantation. Almost 40-50% of     patients have such poor liver function and co-morbid conditions that only supportive cares     are offered. Thus the median survival time is 18-24 months for resectable disease, 6 months     for unresectabe disease and 3 months for metastatic disease.      Current screening methods for HCC in high risk patients depend on alpha-fetoprotein (AFP) and     ultrasound of the liver. Neither test is sensitive or specific enough for early detection.     Therefore, early diagnosis with novel protein biomarkers is needed urgently and may provides     hope to improve treatment outcome.      Our preliminary study in 49 HCC patients have identified several proteins such as truncated     complement C3a, albumin, B2 microglobulin, may be potentially helpful in early diagnosis. We     have started a large prospective and longitudinal study in July 2006, with nearly 100     patients accrued. This application is to extend and expand our current study. We aim to (i)     identify and validate novel protein biomarkers for early diagnosis of HCC (ii) conduct     longitudinal proteomics with most up-to-date methods to discover new biomarker for early     detection and prognostication of HCC (iii) set up gene and plasma depository and clinical     database for HCC in collaboration with Singapore Tissue Network.   "
200943|NCT00465855|"     This randomized trial will investigate important clinical outcomes of patients with acute     carbon monoxide poisoning randomized to receive either one or three hyperbaric oxygen     treatments.   "
200944|NCT00465868|"     KoMPiS is a contrast aided cardiac magnetic resonance study of microvascular obstruction and     left ventricular remodelling following acute revascularised anterior myocardial infarction.     The study will monitor the included patients for 12 months following the acute myocardial     infarct and collect data from MR scans and blood samples. The study is designed to     demonstrate that obstruction of blood flow in the peripheral (small) vessels of the cardiac     muscle is an important factor in the post-MI development of left ventricle dysfunction that     occurs in many patients, despite of a successful re-opening of the occluded coronary artery     that caused the MI.   "
200945|NCT00465881|"     The purpose of this study is to obtain sufficient continuous glucose monitoring (CGM) data in     a manner that provides clinical information that is not available using conventional     self-monitored blood glucose. Currently, a formal method does not exist for evaluating CGM     data except for looking at each glucose reading across the days a CGM system has been worn     and evaluating it based on clinical practice experience. The hope is that a mathematical     model can be developed that will enable health care providers to quickly and easily determine     what changes in diabetes treatment need to be made after CGM data is obtained.   "
200946|NCT00465894|"     The purpose of this study is to determine if long acting tolterodine confers more benefit     than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12     weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen     confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms.     Secondary outcomes were to assess if the addition of the other therapy to the treatment     regimen conferred benefit at 24 weeks and 52 weeks.   "
200947|NCT00465907|"     Evaluate the efficacy and toxicity of the weekly combination chemotherapy of Paclitaxel,     Carboplatin and Irinotecan in Stage IIIb and IV NSCLC with maligant pleural effusion   "
200963|NCT00466115|"     This research is being done to see if the combination of sargramostim and MS-275 will help to     improve the bone marrow function of people with myelodysplastic syndrome (MDS) or acute     myeloid leukemia(AML).      It will also determine the side effects of this combination.   "
200964|NCT00466128|"     The purpose of this study is to determine if the short term use of indomethacin will reduce     the number of women delivering within 48 hours when given to women with preterm premature     rupture of membranes (PPROM) between 24- 32 weeks of gestation. We hypothesize that     indomethacin's anti-inflammatory and tocolytic action will reduce the number of women     delivering within 48 hours when given to women with PPROM between 24-32 weeks of gestation.   "
200948|NCT00465920|"     In the last decade cognitive behavioural therapy (CBT) approaches for patients with     schizophrenia have been developed, which where especially designed to reduce severity of     positive symptoms, readmission rates, treatment non-compliance and disability. Although CBT     addresses the key problems of early onset psychoses (EOP)treatment and first evaluations of     CBT in adults with schizophrenia are promising, no experience with CBT in adolescents with     EOP are available. Therefore the present study is conducted to develop a modified CBT (mCBT)     for adolescents with EOP, to explore its acceptance and feasibility and to provide data for a     realistic estimation of achievable effect size. Patients are randomized to receive either     mCBT+TAU or TAU over a 9 month period. mCBT is an individual outpatient treatment of 20     session and 5 psychoeducational sessions with parents. Follow-ups for two years every 6     months are planned.   "
200949|NCT00465933|"     The purpose of this study is to evaluate the efficacy of all-trans retinoic acid (ATRA) and     idarubicin (AIDA) with a dose reduction in patients older than 70 years of age in the     remission induction of acute promyelocytic leukemia (APL).      With regard to the induction, the excellent results obtained by the combination of ATRA and     idarubicin (AIDA), especially in terms of antileukemic efficacy (1% of resistance), do not     support the introduction of substantial changes in this combination. However, given that most     of the induction failures were caused by complications, especially of a hemorrhagic nature,     and that these had a major impact in the hyperleukocytic forms and in patients older than 70     years of age, the induction was modified as follows:        1. Reduction of idarubicin dose in patients older than 70 years of age (three days instead          of four);        2. Early administration of corticosteroid therapy in all patients as ATRA syndrome          prophylaxis. A preliminary analysis of the Italian Group for Adult Hematologic Diseases          (Gruppo Italiano Malattie Ematologiche dell'Adulto, GIMEMA) has shown that low dose          prednisone use in a prophylactic manner appears to reduce the incidence and severity of          the ATRA syndrome, which could also have a favorable impact on the hemorrhagic mortality          (non-published data); and        3. Treatment of the hyperfibrinolysis with an antifibrinolytic agent (tranexamic acid). It          has been recently reported that APL cells present abnormally high levels of annexins          (especially annexin II), and that these levels may provide the fundamental mechanism for          the hemorrhagic complications in APL by increasing the production of t-PA dependent          plasmin. These findings provide new reasons for the introduction of tranexamic acid in          the hemorrhagic prophylaxis of APL.   "
200950|NCT00465946|"     Syncope is a syndrome consisting of a relatively short period of temporary and self-limited     loss of consciousness caused by transient diminution of blood flow to the brain (most often     the result of systemic hypotension). The objective of this study was to evaluate the effect     of salt supplementation in vasovagal syncope prophylaxis.   "
200951|NCT00465959|"     To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD   "
200952|NCT00465972|"     This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use     in patients who are HIV positive and suffer from insomnia.   "
200953|NCT00465985|"     This study is designed to provide efficacy and safety data for ACZ885 (a fully human     anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection     subcutaneously (s.c.) in patients with Muckle-Wells Syndrome.      Part I is an 8-week open-label, active treatment period to identify ACZ885 responders.      Part II is a double-blind, placebo-controlled period to assess primarily the efficacy of     ACZ885 compared to placebo.      Part III is an open-label, active treatment period where patients will receive ACZ885 every 8     weeks after withdrawal or completion of Part II.   "
200954|NCT00465998|"     The aim of the study was to evaluate any possible associations between engagement and     position of the fetal head and the outcome of labor in women with induced labor, and to     compare the value of ultrasound measurements in predicting the time from induction to     delivery and operative deliveries.   "
200955|NCT00466011|"     Introduction: The full night polysomnography (PSG) in sleep lab is the gold standard to     Obstructive Sleep Apnea (OSA) diagnosis. However, there is a need to evaluate simple and     accurate home diagnostic equipment that can reliably detect or exclude OSA. The aim of our     study was to evaluate if an ambulatory portable monitor (SD) is accurate to measure     apnea-hypopnea index (AHI) in OSA patients referred to a Sleep Lab. Methods: Patients with     clinical suspicion of OSA were selected. Three-order randomized evaluations had been     performed within a period of two weeks: the 1) SD (Stardust®, Respironics, Inc, USA) was used     at patients home (SD home), 2) SD was used simultaneously with PSG in the sleep lab (SD+PSG     lab) and 3) PSG was performed without the use of SD (PSG lab). Four AHI were generated and     analyzed: AHI from SD home, AHI from SD of SD+PSG lab, AHI from PSG of PSG+SD lab and AHI     from PSG lab. The analyses of SDs and PSGs recordings were performed by two blinded     technicians.   "
200956|NCT00466024|"     The purpose of this study is to conduct a randomized controlled trial of the efficacy of a     combination of HEPA room air cleaners plus an ETS reduction behavior training as compared to     either HEPA air cleaners plus standard asthma education or delayed HEPA air cleaners and     standard asthma education (control group).   "
200957|NCT00466037|"     Rituximab is a genetically engineered chimeric anti-CD20 monoclonal antibody that selectively     targets CD20+ B cells and induces a transient depletion of the CD20+ mature B cell     subpopulation.The objective of our study was to assess the effect of rituximab on the     efficacy and safety of influenza virus vaccine in patients with rheumatoid arthritis (RA).   "
200958|NCT00466050|"     Thirty patients scheduled to coronary angiography and IVUS in according to their treating     physician decision will be enrolled in the study. The coronary angiography and IVUS will be     done on according to regular clinical standards.      As the study protocol, 40 cc of blood will be drawn from the patients after written informed     consent.      The laboratory tests will be processed for the above mentioned serum markers of unstable     plaque.      A multivariate correlation test will be done between the different serum markers and the     plaque morphology by angiography and composition (virtual histology) by IVUS.   "
200959|NCT00466063|"     This registry will evaluate long-term safety and efficacy of deferasirox in children with     transfusional iron overload.   "
200960|NCT00466076|"     The purpose of the project is to investigate in eyes with dry AMD, the efficacy and safety as     preventive therapy of the immunomodulatory substance named copaxone which had been proven as     safe and effective agent for a neurodegenerative disease, in arresting the progression as     well as the conversion of dry AMD to wet AMD. The hypothesis that the immunomodulatory agent     copaxone proven for a neurodegenerative disease may work in the eye is revolutionary and may     open a new avenue of preventive treatment for the disease which is the major cause of legal     blindness in the industrial world   "
201731|NCT00481520|"     The primary purpose of the study is to assess whether SAM-531, an investigational drug, is     safe and well tolerated, compared with placebo (a medically inactive substance), in subjects     with mild to moderate Alzheimer's disease.   "
200966|NCT00466154|"     Aspirin resistance is the persistent platelet activation, demonstrated by platelet function     tests (1).      The hypothesis is that:LDL lowering by statin in patients with aspirin resistance can improve     the effect of aspirin due to the potential decreasing of cholesterol content in the platelet     membranes.      Patients and methods:Forty hypercholesterolemic patients with aspirin resistance after 5 days     of treatment with aspirin and high LDL and triglycerides<300 mg/dL, will be enrolled.      Ten healthy volunteers will be the control group.   "
200967|NCT00466167|"     The general aim of this trial is to determine the efficacy (as measured by the change from     baseline to the end of the maintenance phase in the total score for Unified Parkinsons     Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER,     in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in     Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with     advanced Parkinsons Disease and motor fluctuations.      In addition, a numerical comparison of the efficacy of pramipexole extended release versus     pramipexole immediate release will be done.      The efficacy of pramipexole immediate release will also be compared to placebo, for assay     sensitivity.   "
200968|NCT00466180|"     Taking antiretrovirals once-a-day is considered the simpler way to improve adherence.     However, it is not know if this assertion apply to patients taking their medication     twice-a-day who change to once-a-day.      We hypothesized that once-daily dosing improves adherence.   "
200969|NCT00466193|"     The purpose of the study is to evaluate sleep onset following administration of zolpidem     tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.   "
200970|NCT00466206|"     This is a medical research study.      The study investigators have developed a method to gradually repair pectus excavatum (sunken     chest) deformity by placing a magnet on the sternum (breastbone) and then applying an     external magnetic force that will pull the sternum outward gradually.      Potential candidates for this study are children and adolescents with a previously diagnosed     congenital pectus excavatum (sunken chest) deformity who are otherwise healthy and are     seeking corrective surgery for their condition. They will be residents of the U.S. and     between the ages of 8 and 14 years of age. Potential candidates and their families will have     already been counseled about this condition and about the standard way to repair this     deformity.      The purpose of this study is to test what effects, good and/or bad, placing an     external/internal magnetic device has on correcting pectus excavatum deformity in children,     and the safety of using such a device for treatment.   "
200971|NCT00466219|"     The aim of the study is to assess whether patients with recurrent hepatitis C after liver     transplantation will benefit from a treatment with ribavirin/PEG-IFN-alpha combined treatment     for 48 weeks.   "
200972|NCT00466232|"     The primary objective of this study is to determine the maximum tolerated dose of sorafenib     up to the full active dose when combined with standard weekly dosing of topotecan in patients     with recurrent small cell lung cancer and to characterize the toxicities associated with the     combination of topotecan and sorafenib in this patient population   "
200973|NCT00466245|"     A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine-     naive subjects at three dose levels.   "
200974|NCT00466258|"     Main objective:        -  To evaluate the applicability of the treatment:             1. To evaluate the treatment toxicity according to the Common Terminology Criteria               (CTC) version 3.0 of the National Cancer Institute (NCI).             2. To evaluate opportunistic and non-opportunistic infections after 6 cycles of               treatment with rituximab plus cyclophosphamide, doxorubicin, vincristine, and               prednisone (R-CHOP) administered every 14 days and highly active antiretroviral               therapy (HAART) in patients with diffuse large B cell lymphoma (DLBCL) and HIV               infection.             3. To evaluate the adherence to the treatment with 6 cycles of R-CHOP considering the               delays in the administration of the cycles and the reductions in the doses of               chemotherapy (planned dose administered in predicted term).      Secondary objectives:        -  To evaluate the efficacy of the treatment in patients with DLBCL and HIV infection after          6 cycles of treatment with R-CHOP administered every 14 days (R-CHOP/14):             1. To determine the global response and complete remission tax.             2. To evaluate the duration of the response.             3. To evaluate the probability of event-free survival in 5 years.             4. To evaluate the probability of global survival in 5 years.        -  To identify predictive factors of response after 6 cycles of treatment with R-CHOP          administered every 14 days in patients with DLBCL and HIV infection.        -  To evaluate the impact of the therapeutic combination of R-CHOP and HAART in the          parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count).   "
200975|NCT00466271|"     The purpose of the study is to validate the diagnostic accuracy and reproducibility of SAPI     to predict significant hepatic fibrosis in HCV patients with PNALT who are scheduled to     receive combination therapy with pegylated interferon plus ribavirin and percutaneous liver     biopsies.   "
200976|NCT00466284|"     A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients     will be treated.      STUDY OBJECTIVES      Primary: Objective response rate      Secondary: Progression free survival, Overall survival and Safety of Tarceva   "
200977|NCT00466297|"     Collaborative practice may improve patient outcomes in specific disease conditions and health     care settings. The SCRIPT Programme is an intervention to implement informal, but structured,     communication etiquette between members of interprofessional ward-based clinical teaching     units (CTUs) in General Internal Medicine (GIM) hospital divisions.   "
200990|NCT00471835|"     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the     tumor and cause less damage to normal tissue.      PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic     body radiation therapy and to see how well it works in treating patients with stage I or     stage II non-small cell lung cancer.   "
200992|NCT00471861|"     The purpose of this study is to determine whether C-Reactive Protein (CRP) is elevated in     patients with active migraine headaches. Secondary goal is to determine whether other     inflammatory markers, such as Calcitonin Gene Peptide (CGRP), Vasoactive Intestinal     Polypeptide (VIP) or Substance P (SP) are elevated in patients having a migraine headache.   "
200978|NCT00466310|"     We plan to use a metabolomics lipid platform to map biochemical signatures in unmedicated     schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug     aripiprazole and compare that to lipid perturbations induced by risperidone. These drugs have     inherently different risk for metabolic adverse effects and patients respond to them     differently. Metabolic signatures for the drugs capture significant biochemical information     that could explain part of the basis for varied drug response within individuals and will     highlight pathways implicated in drug action and in disease pathogenesis possibly enabling     new drug design strategies. In addition, we will compare patients to healthy controls at     baseline in regard lipid profiles.   "
200979|NCT00466323|"     The purpose of this study is to learn how to help veterans play a stronger role in shaping     their mental health care. Specifically we want to see if we can help veterans improve their     mental health treatment by helping them decide if they want to involve family in their mental     health treatment, and if so, how. The study will compare a family member provider program     to an enhanced treatment as usual approach in achieving these goals.   "
200980|NCT00471705|"     Cutaneous leishmaniasis (CL) is a worldwide disease, endemic in 88 countries, that has shown     an increasing incidence the last two decades. It is estimated that in 2005, about of 20,000     new cases of CL were diagnosed in Colombia.      So far, pentavalent antimony compounds have been considered the treatment of choice with a     percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by     their adverse events and disadvantages. Previous studies have shown that miltefosine could be     a potential alternative of treatment for CL.      The main objective of this study is to evaluate the efficacy and safety of miltefosine or     thermotherapy for the treatment for CL. In this study the efficacy of oral treatment of     miltefosine 150 mg/day for 28 days or a thermotherapy device used for one session at 50     celsius degrees during 30 seconds will be compared with the standard treatment of     intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (GlucantimeÒ) for 20 days     in CL parasitologically proven patients.      This trial will be conducted according to the International approved GCP (Good Clinical     Practice) guidelines.   "
200981|NCT00471718|"     RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-751 and to     see how well it works in treating patients with metastatic prostate cancer that did not     respond to hormone therapy.   "
200982|NCT00471731|"     Premature ovarian failure (POF) is known to be associated with an increased risk of ocular     surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen     in this condition. From preliminary data, we suspect that women with Turners syndrome (45,     XO), a genetic abnormality that affects sex hormone levels, are also at increased risk of     ocular surface disease. Comparing POF and TS women may allow us to distinguish different     mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen     and androgen) alterations posed by POF and TS....   "
200983|NCT00471744|"     The investigators hypothesize that Levetiracetam is as effective as Sulthiame in the     treatment of children with BECTS. Patients entering the HEAD-Studie are either treated with     Leveitracetam or Sulthiame over a 6 months period. Patients are equally randomised to one of     the two treatment regimens. Administration of medication as blinded capsules.   "
200984|NCT00471757|"     The proposed study aims to provide current information, etiology and outcome of     community-acquired pneumonia (CAP), risk factors for for CAP in isolates of Streptococcus     pneumoniae and Haemophilus influencae, Mycoplasma pneumoniae, chlamydia pneumoniae and     Legionella. Risk factors, including patient demographics, comorbid illnesses, setting of     presentation, causative organisms, antibiotic history, and resistance profiles will be     assessed and outcome will be recorded.   "
200985|NCT00471770|"     To determine the proportion of hospitalized pneumonia cases in children aged 60 months or     less associated with vaccine-preventable Streptococcus pneumoniae serotypes (4, 6B, 9V, 14,     18C, 19F, 23F).   "
200986|NCT00471783|"     To determine if flossing with a dental floss presoaked in chlorhexidine, an anti-microbial     mouth wash, would improve the clinical signs of gingivitis, an inflammation of the gums     characterized by red, swollen, bleeding gums. And to determine if applying chlorhexidine via     dental floss would result in tooth staining, which is common with chlorhexidine mouthwashes.   "
200987|NCT00471796|"     There is supposed that patients with functional esophageal disorders such as functional     heartburns and functional chest pain have common underlying mechanisms of symptom generation.     These include esophageal dysmotility, non-acidic gastro-esophageal reflux,     duodeno-gastro-esophageal reflux, esophageal hypersensitivity, and psychological comorbidity.      The treatment of these patients is the growing challenge in the primary care medicine and in     the gastroenterological practice. It was postulated that functional disorders of the     esophagus are the main reason for PPI failure in patients with heartburn.      The aim of the study is to evaluate the role of biofeedback in the treatment of patients with     functional chest pain and functional heartburns.   "
200988|NCT00471809|"     The MARS trial is a randomized, double-blind, parallel group study that compares the capacity     of azithromycin or montelukast to placebo as effective adjunctive therapy that allows     reduction of inhaled corticosteroids in children ages 6 to 17 years with moderate to severe     persistent asthma. The primary null hypothesis is that in children with moderate-to-severe     persistent asthma, a macrolide antibiotic (azithromycin) or a leukotriene receptor antagonist     (montelukast) will provide a steroid-sparing effect when compared to placebo as the dose of     inhaled corticosteroid is reduced. This will be tested following achievement of control of     symptoms with moderate to high-dose inhaled corticosteroid in combination with a long-acting     bronchodilator agonist. Use of these doses for the inhaled corticosteroid will be based on     NHLBI step-up guidelines to achieve asthma control.   "
200989|NCT00471822|"     Primary Objective: Evaluation of the      - Carriage rate of Streptococcus pneumoniae in the nasopharynx of children      Secondary Objective:        -  Carriage rate and distribution of Streptococcus pneumoniae serotypes        -  Estimation of prevalence rate of antibiotic-resistant Streptococcus pneumoniae strains        -  Distribution of Staphylococcus aureus strain        -  The influence of risk factors in the Streptococcus pneumoniae carriage rate in children   "
200994|NCT00471887|"     RATIONALE: Monoclonal antibodies, such as ticilimumab (CP-675,206), can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them.      PURPOSE: This phase II trial is studying how well ticilimumab (CP-675,206) works in treating     patients with stage IIIC or stage IV melanoma.   "
200995|NCT00471900|"     DHEA is an adrenal deriven androgen precourser. The impact of DHEA substitution therapy in     adrenal failure is unknown as well as the physiologically effects of DHEA is unknown. Effects     of physiologically DHEA substitution is investigated in the model of female adrenal failure.   "
200996|NCT00471913|"     Study focus is femoral shaft (thigh bone) fractures (break) that require surgical treatment     under anaesthetic to stabilize the femur fracture. This is usually done by placing a metal     nail and screws inside the femur (thigh) bone.      This study has been designed to allow us to learn more about the effect of using a different     starting point to insert the nail into the body in order to access the fracture and fix it.     This question is important because to date, all entry points currently used do result in some     muscle damage. In order to minimize this damage a lateral (side) entry nail has been     developed and is currently in use at many centres. This nail is new but, the lateral entry     technique for these types of fractures has been used extensively in the past, and this nail     has been developed in order to better accommodate the technique.      It is believed that entering laterally instead of going deeper into the tissue to access the     bone to fix it is going to result in less muscle damage which in turn will improve functional     outcome.   "
200997|NCT00471926|"     In order to assess more completely the levels of diabetes care delivered in Taiwan, we now     have nationally standardized performance measures that can evaluate quality of diabetes care     accurately and reliably. These performance measures were seriously reviewed and discussed in     the aspects of their practicability, feasibility and compliancy, through a series of     nation-wide consensus meetings by a number of multidisciplinary professionals of Taiwan     Diabetes Care Teams ( TDCTs ), before delivering into the clinical settings ( 10 ).      Conceptually, these measures will enhance uptake of research into practice and may ultimately     improve diabetes care and clinical outcomes. Along with the serial developments mentioned     above, the BNHI ( the sole healthcare insurance organization in Taiwan ) has been fully     involved, from the very beginning, in the formation and development of these performance     measures which have totally been included in the development of the Diabetes Case Management     Program ( DCMP ) 2001 later on. The DCMP 2001 is a unique program that has been delivered     into the nation-wide clinical practices since Dec. 2001 in Taiwan. It has linked the quality     of diabetes care to the monthly income ( reimbursed from BNHI ) of the registered clinical     diabetes educators ( i.e., physicians, nurses and dietitians ) for enhancing and assuring the     complete implementation of these performance measures in diabetes care. It has been     recognized that a consensus on measures at national level could provide a method for     assessing care within and across healthcare settings while providing a meaningful mechanism     for quality improvement. In this proposal, we are going to develop the Diabetes Quality     Improvement Program ( DQIP ) based on the DCMP 2001 in Taiwan.      Initially, we are going to establish the continuous diabetes quality monitoring system and     then to evaluate the (1) the lifestyles and eating habits and dietary compositions in type 2     diabetes mellitus (2)The relationships between lifestyles and eating habits and dietary     compositions in diabesity.   "
200998|NCT00471939|"     This is a phase II, multi-centre, controlled study comparing the safety and tolerability on     wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB     versus staples applied in the same patient to burn areas requiring autologous meshed skin     grafting.   "
200999|NCT00471952|"     The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with     caffeine for treating acute attacks of migraine.      Each subject will have 3 months to treat 3 acute migraine headache attacks. Each subject will     be dispensed one box containing 3 packets of study medication labeled for Headache #1,     Headache #2, or Headache #3. Each packet wil contain either Maxalt 10mg MLT or a Maxalt     placebo (sugar pill), and a capsule containing either caffeine 75mg or a capsule containing     placebo (sugar).      One headache will be treated with a combination of Maxalt 10mg MLT and caffeine.      Another headache will be treated with a combination of Maxalt 10mg MLT and a capsule     containing placebo.      A third headache will be treated with just placebo.      Neither the subject, the study coordinator, or your study doctor will know in which order you     will receive the three different treatments. This information is available in case of     emergency.   "
201000|NCT00471965|"     Primary:        -  Overall Survival (OS)      Secondary:        -  Time to Tumor Progression (TTP)        -  Response Rate (RR)        -  Improvement of Quality of Life (QoL)        -  Safety        -  Secondary resection rate   "
201002|NCT00471991|"     The aim of this monocenter, open-label, randomized study is to determine the ovulation     inhibitory effect of the combined oral contraceptive (COC) SH T04769G and to collect     supplementary data regarding the ovulation inhibitory effect of the COC Valette® SH D00659AF     (0.03 mg EE and 2.0 mg DNG), each applied for two treatment cycles in 60 healthy female     volunteers, aged 18-35 years.Combined oral contraceptives consist of two components: an     estrogen and a progestin. The estrogen is required for a regular cycle; the progestin ensures     the protection against unwanted pregnancy. In a sufficient dosage, progestins prevent     ovulation. The investigational product is an oral contraceptive that contains the estrogen     ethinylestradiol and the progestin dienogest as active ingredients. 21 tablets are taken each     cycle followed by a 7-day tablet-free interval. Thus, the whole cycle lasts for 28 days.The     marketed oral contraceptive Valette® contains both ingredients (ethinylestradiol and     dienogest) in a higher dose. One half of the volunteers (30 volunteers) will receive this     product. Efficacy and safety were already confirmed by numerous clinical studies.Another 30     volunteers will receive the investigational product. The dose reduction is not assumed to     have a negative impact on tolerance.The study is aimed to show whether the reduced dosage is     sufficient for contraception.Course of the study:The study consists of 4 cycles (one cycle     before treatment, followed by two treatment cycles and one post-treatment cycle) resulting in     approx. 16 weeks of study participation. The post-treatment cycle is aimed to observe the     return to the normal function of the ovaries. Volunteers will have to come for a visit every     2 to 4 days over the whole study period.Visit 1The investigator will explain the study in     detail and the volunteer will be given ample time and opportunity to ask questions. If all     questions were answered the volunteer will decide on participation in the study. If she     decides to take part, she will give her written consent on the Informed Consent     Form.Afterwards, a pregnancy test will be performed, a complete medical, surgical and     medication history will be recorded and physical and gynaecological examinations will be     performed. Transvaginal ultrasonography will be done and smear from the mouth of the uterus     is taken for precaution of cancer.Blood (10 ml) will be drawn to determine routine safety     lab, heart rate and blood pressure will be measured and height and weight will be     recorded.Volunteers will be provided with a diary that has to be filled in on a daily basis     during the whole study period (bleeding records, intake of study medication, performance of     pregnancy tests).During the whole study non-hormonal methods of contraception have to be used     (condom plus spermicide; diaphragm with spermicide). During the cycle before study treatment,     the function of the ovaries is studied by transvaginal ultrasonography and determination of     hormonal parameters from blood samples. The mouth of the uterus is inspected during each     visit and the cervical smear will be investigated. Visits will be performed every 4 days.If     ovulation can be confirmed, volunteers will be randomized to one of the treatment     groups.Volunteers who will receive the investigational product will undergo a blood sampling     on a given day of this cycle to determine the baseline hormonal status (fasting condition).A     home pregnancy test has to be done by the volunteer before intake of the study medication.     Only in case a pregnancy is excluded, intake of study medication will start.Treatment     cycles:During these cycles, visits are performed every 3 days to determine ovarian activity     (transvaginal ultrasonography, blood sampling, inspection of the mouth of the uterus and     cervical smear investigation). Adverse events will be recorded and diary entries will be     controlled by the investigator.Volunteers who receive the investigational product have to     undergo a series of blood sampling during the 2nd treatment cycle to evaluate the     pharmacokinetic (liberation, absorption, distribution, metabolization and excretion) of the     new oral contraceptive.Post-treatment cycle:Non-hormonal contraceptive methods have also to     be used during the post-treatment cycle. It starts immediately after the 2nd treatment cycle,     i.e., on the 8th day after the last tablet intake and ends with the start of the next     menstrual bleeding. Visits will be performed every 4 days to determine the return of ovarian     activity by transvaginal ultrasound measures and blood sampling for hormone determination.     After end of the next menstrual bleeding, a final Visit including physical and gynaecological     examinations will be performed. Options for further contraceptive methods will be discussed     with the investigator.   "
201003|NCT00472004|"     This is a Phase IV prospective, randomized, open label, comparative, multicenter study in     generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and     Livial (Tibolone).   "
201004|NCT00472017|"     This phase I trial is studying the side effects and best dose of vandetanib when given     together with radiation therapy in treating young patients with newly diagnosed diffuse brain     stem glioma.   "
201005|NCT00472030|"     The primary objective is to test the safety and efficacy of Xolair in the treatment of the     autoimmune blistering disease, bullous pemphigoid (BP).      This is a pilot, open label case-control study. Patients treated with Xolair will be compared     to patients receiving standard treatment with prednisone.      The enrollment period for the study is 24 weeks: 16 weeks active treatment and 8 additional     weeks of observation.   "
201017|NCT00472186|"     This study was designed to determine whether post-operative pain following a tonsillectomy     can be reduced by adding an antacid-like medication to the medications taken after surgery.     It is hypothesized that even a small amount of stomach acid backing up and entering the mouth     can increase post-tonsillectomy pain. Therefore, the use of an antacid-like medication should     help to decrease pain and reduce the amount of narcotic medication required for pain control.   "
201018|NCT00472199|"     The primary objective of the current study will be the evaluation of long-term efficacy of a     26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless     Legs Syndrome (RLS) in comparison to placebo.      The key secondary objectives are to assess the effects on clinical global impressions -     global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS     responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary     objectives are to investigate the incidence and severity of augmentation and rebound and to     assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS     symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the     IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS     (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on     safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.   "
201006|NCT00472043|"     Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light     activation of a photosensitiser in the presence of oxygen. These cells accumulate more     photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon     illumination.      For skin diseases, there has been an increasing interest in using precursors of the     endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors have     been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®,     contains the methyl ester of ALA, which penetrates the lesions well and shows high lesion     selectivity .      In vitro studies of animal and human tissues have shown significant intracellular formation     of photoactive porphyrins after addition of Metvix®. The increased levels of photoactive     porphyrins induced cytotoxic effects in tumour cells after photoactivation.      The primary objective is to compare PDT with Metvix® cream to PDT with placebo cream in terms     of patient complete response rates based on histologically verified disappearance of the     lesions at 6 months after last treatment cycle.      Secondary objectives are to compare the two treatments in terms of histological and clinical     mean patient response weighted by the number of lesions within a patient, lesion response     rates across patients, clinical complete patient response, cosmetic outcome and adverse     events.   "
201007|NCT00472056|"     Cohort 1: Patients who are less than or equal to 65 years of age.      1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose     rituximab)      Cohort 2: Patients who are older than 65 years of age        1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high          dose rituximab)        2. To determine the treatment related mortality (TRM)   "
201008|NCT00472069|"     Stress urinary incontinence is a frequent condition that can be caused by urethral sphincter     insufficiency and results in a dramatic deterioration of the quality of life. We developed a     new therapeutic strategy for stress urinary incontinence based on the implantation myofibers     with their satellite cells in the urethra. The aim of this procedure is to generate     functional tissue acting like a new sphincter in the urethra   "
201009|NCT00472082|"     The toxicity of calcineurin inhibitors(CNI)is a major factor limiting the success of renal     transplantation. This protocol aims to replace the calcineurin inhibitor, tacrolimus, with     efalizumab early after transplantation in patients with mild impairment of renal function in     order to minimize the toxicities of CNI.   "
201010|NCT00472095|"     Diabetes with poor sugar control can lead to blindness, heart attacks, and amputations.     Latinos are more at risk for diabetes. A fotonovela is a type of comic book commonly read by     Latinos that might be a way to teach them about the risk of high sugars. The researchers will     give patients either a fotonovela about diabetes or one with nothing to do with diabetes.     Then they will compare how well sugars were controlled afterward in each group. This way they     can see if these fotonovelas were useful.   "
201011|NCT00472108|"     Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light     activation of a photosensitiser in the presence of oxygen. These cells accumulate more     photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon     illumination.      For skin diseases, there has been an increasing interest in using precursors of the     endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors have     been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix, contains     the methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity.      In vitro studies of animal and human tissues have shown significant intracellular formation     of photoactive porphyrins after addition of Metvix. The increased photoactive porphyrins     levels induced cytotoxic effects in tumour cells after photoactivation.      The primary objective is to compare PDT with Metvix cream to PDT with placebo cream in terms     of patient complete response rates based on histologically verified disappearance of the     lesions at 6 months after last treatment cycle. Secondary objectives are to compare the two     treatments in terms of histological and clinical mean patient response weighted by the number     of lesions within a patient, lesion response rates across patients, clinical complete patient     response, cosmetic outcome and adverse events.   "
201012|NCT00472121|"     The purpose of the study is the examine the precision of acceleromyography and     mechanomyography during recovery from a neuromuscular blocking agent and to examine whether     there is any difference in monitoring block at the dominant or non-dominant arm. Our     hypothesis is that there is no significant difference in neither the precision nor the level     of block in the contralateral arms.   "
201013|NCT00472134|"     The purpose of this study is to determine the effects of a local anesthetic dispensed via a     tiny catheter device, called the ON-Q PainBuster pump, placed during surgery on top of the     mesh used in the laparoscopic repair of ventral hernias. The goals are:        -  reducing postoperative pain from this procedure        -  decreasing length of hospital stay        -  reducing or eliminating amount of post-operative narcotics used   "
201014|NCT00472147|"     Sudden cardiac death is the most frequent cause of death in industrialized countries. The     most efficient interventiont in ventricular fibrillation is defibrillation in an appropriate     timely manner. But since the intervention of defibrillation the optimal shock energy is     unknown. As a too low energy is not able to terminate ventricular fibrillation a too high     energy may cause asystole wich jeopardizes survival itself. We study the efficacy of     different shock energies on the termination of ventricular fibrillatiion and survival.   "
201015|NCT00472160|"     Critically ill patients are predisposed to oxyhaemoglobin desaturation during intubation. For     the intubation of hypoxemic patients, preoxygenation using non invasive ventilation (NIV) is     more effective at reducing arterial oxyhaemoglobin desaturation than standard method.      Objectives: To find out whether NIV, as a preoxygenation method, is more effective at     reducing the degree of organ dysfunction/failure than standard preoxygenation during the week     following endotracheal intubation.   "
201016|NCT00472173|"     Pulp necrosis is one of the main complication of dental trauma. When it happens on an     immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy     called apexification is required to induce the formation of a calcified apical barrier     allowing a permanent and hermetic root filling.The aim of this study is to compare the     efficacy of a new apexification method using Mineral Trioxide Aggregate (MTA®) with the     reference treatment based on calcium hydroxide repeated stimulations.   "
201019|NCT00472212|"     Hyperopia (farsightedness) has been reported to be associated with reduced visual perceptual     and reading abilities. However, there is controversy regarding whether or not to prescribe     for low to moderate amounts of hyperopia. The Correction of Hyperopia In Children Study     (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle     correction for moderate amounts of hyperopia on visual function, symptoms, attention, and     reading skills in children.   "
201020|NCT00472225|"     Chronic GVHD is the most common late complication following allogeneic stem cell     transplantation. It has features resembling autoimmune disorders such as scleroderma, primary     biliary cirrhosis, bronchiolitis obliterans, chronic immunodeficiency etc. Thus, chronic GVHD     can lead to debilitating complications such as joint contractures, blindness, end-stage lung     disease, etc so that chronic GVHD has a major impact both on survival as well as quality of     life. Although its pathogenesis is still poorly unclear, it has been reported since 2000 that     B cell-mediated immunity may also contribute to development of chronic GVHD other than T     cells. Thus, targeting against B cell may be a useful treatment strategy in the treatment of     chronic GVHD.      The purpose of this study is to determine whether rituximab, an anti-CD20 monoclonal kimeric     antibody is effective in the treatment of chronic graft-versus-host disease (chronic GVHD)     refractory to steroid.   "
201021|NCT00472238|"     A severely reduced left ventricular ejection fraction is associated with increased mortality     due to pump failure as well as to malignant ventricular arrhythmia. We hypothesize that     targeted training may lead to improved survival and to increased parameters of risk     stratification for malignant arrhythmia. Additionally, the training may lead to an improved     psychological and mental condition of the patients   "
201022|NCT00472251|"     It is widely-accepted that serum testosterone level and BMI (body mass index) representative     of the degree of obesity has negative correlation. Considering the fact that obesity is being     mentioned as a risk factor for development of prostate cancer as well as other various     life-threatening diseases (example: cardiovascular problems), the effect of BPH treatment     agents on BMI is a subject that should certainly be elucidated. Meanwhile, to our knowledge,     no prospective study has so far been performed on such issue in Asian population. Prior to     generating hypothesis of the effect of 5 alpha reductase inhibitor on BMI, the real effect of     5 alpha reductase inhibitor on BMI change in Korean BPH patients has to be observed in real     clinical practice. This study will test the effects of one-year medication of 5 alpha     reductase inhibitor on BMI among Korean men with BPH.   "
201023|NCT00472264|"     It is hypothesised that there is a difference between the uptake of a radioactive substance     ([18F]fluorodeoxyglucose (FDG)) in the lungs of patients with Chronic Obstructive Pulmonary     Disease (COPD) and healthy volunteers.   "
201024|NCT00472290|"     This is an open label extension study of romiplostim for treatment of thrombocytopenia     (platelet count ≤ 50 x 10^9/L) in MDS subjects. The study is designed to assess the long-term     safety of treatment with romiplostim, as measured by incidence of overall adverse events, the     incidence of bleeding events, the utilization of platelet transfusions, and the duration of     platelet response. The study will further describe the time to disease progression to acute     myeloid leukemia (AML) and survival.   "
201025|NCT00472303|"     The purpose of this study will be to determine whether tapentadol (CG5503) is effective and     safe in the treatment of chronic tumor related pain compared to placebo. In addition     tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as     slow release (SR).      *Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to     as extended release (ER) in the United States.   "
201026|NCT00472316|"     This study is designed as a cluster-randomized trial. The cluster unit is at the community     level. Communities will be randomized to 1 of 2 study arms: DOTS+ACF or DOTS. Communities in     the DOTS+ACF arm will receive door-to-door symptom screening of the entire population by     health care workers between 2 and 4 times over a 9-month period. Those communities in the     DOTS-arm will receive the current standard of care in those communities (PCF). All study     communities will be receiving between 4 and 6 visits by community health workers annually as     part of a program to assess and follow-up illnesses in each household. Households with ill     residents will be visited more often. The intervention for this study is simply adding 3 to 5     simple questions to the current protocol. For subjects responding positively to these     questions, results will be returned to the subject at their home and routine, standard of     care follow-up diagnostic and treatment algorithms will be followed.   "
201027|NCT00472329|"     Major Objectives A. To determine whether stable allogeneic hematopoietic engraftment can be     safely established in patients who have rejected (<5% T Cell Chimerism) a previous allogeneic     hematopoietic stem cell graft by using an allogeneic SCT from an HLA-Identical or     non-identical family donor or unrelated donors, with fludarabine (150mg/m2) and TBI (400cGy),     with post-transplantation immunosuppression utilizing tacrolimus and MMF.      B. To evaluate the incidence of transplant related mortality.      Minor Objectives A. To evaluate the incidence of acute and chronic GVHD after second     allogeneic HCT utilizing Tac/MMF with peripheral blood stem cells from matched or mis-matched     allogeneic donors.      B. To evaluate disease responses and survival after second allogeneic SCT. C. To evaluate the     need for DLI after second transplant for either disease control or persistent mixed     chimerism.   "
201042|NCT00472524|"     The goal of this study is to compare the effectiveness of the administration of sequential     drops, a combination drop and a combination spray for producing mydriasis and cycloplegia.   "
201028|NCT00472342|"     Many adipokines are thought that related with metabolic disturbance such as glucose     intolerance, dyslipidemia, and insulin resistance. It is reported that regular physical     training could prevent the progression of diabetes from prediabetes and improve the insulin     resistance. After physical training, many adipokine levels were changed due to improving     insulin resistance.      In this study, we will examine the various adipokine levels such as adiponectin, RBP-4, and     adrenomedullin after exercise training through exercise prescription in IFG and IGT patients.   "
201029|NCT00472355|"     The purpose of this study is to determine if low doses of apomorphine worsen the motor     symptoms of Parkinson's disease.   "
201030|NCT00472368|"     This single center study will help determine the absorption, metabolism, and excretion of     LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom     no standard therapy exists.   "
201031|NCT00472381|"     Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor     outcome. But the modalities of glucose lowering are still debated. This study will test the     efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous     insulin in acute ischemic stroke.   "
201032|NCT00472394|"     New medical abortion regimens are being tested with increasing frequency. However women's     preferences for certain attributes of the regimes are not being investigated to any great     degree. Consideration of women's preferences in designing new regimens may help to optimize     the medical abortion process. The proposed prospective survey research will attempt to     determine women's preferences for individual aspects of medical abortion treatment and     various regimens, and to determine what attributes of medical abortion treatment may be     driving these preferences. The information collected in this study may be used in developing     future treatment regimens or as the groundwork for future research into preferences,     acceptability, and satisfaction with treatment.   "
201033|NCT00472407|"     Measurement of near point of convergence (NPC) is often critical to the diagnosis of CI. This     study will evaluate NPC measurements with commonly used target types.   "
201034|NCT00472420|"     This single arm study will evaluate the benefit of adding MabThera to standard induction     chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and     tolerability of a MabThera-containing first line regimen will also be assessed. All patients     will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard     chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample     size is <100 individuals.   "
201035|NCT00472433|"     The majority of cases of autoimmune cytopenias, which includes immune thrombocytopenia (ITP),     autoimmune hemolytic anemia, autoimmune neutropenia (AIN) and pure red cell aplasia, will     respond to conventional immunosuppressive therapy with or without splenectomy. There is,     however, a group of patients with refractory or chronically relapsing autoimmune cytopenias     causing life-threatening hemorrhages, infections or anemia. Further problems include the     short- and long-term side-effects of corticosteroids, and the potential toxicity of     immunosuppressive and cytotoxic agents. An alternative and less toxic approach in these     patients may be the treatment with Campath-1H, a humanized IgG monoclonal antibody specific     for the CD52 antigen and present on human lymphocytes and monocytes. The main effect of     Campath-1H is on T cell and it results in a prolonged and profound depletion of the CD4 and     CD8 subpopulations, particularly the CD4 population, and this might reset the immune system     without the need for total immune ablation.Therefore, this study is designed to investigate     safety and efficacy of repeated Campath treatment cycles in autoimmune cytopenia.In order to     minimize possible side effects of accumulating Campath, the 3 treatment cycles will be     administered in consecutively reduced doses.   "
201036|NCT00472446|"     The study investigates the impact on post-operative pain of the superficial cervical block     with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid     surgery under general anesthesia. In addition, cost savings using the cervical block are     evaluated (due to reduced length of hospital stay).      The study is prospective, randomized, double blind, and placebo-controlled. The study is     performed at the Department of Surgery, Cantonal Hospital of St. Gallen.   "
201037|NCT00472459|"     Patients on immunosuppressive therapy, e.g. organ recipients, have a higher occurrence of AK     than the untreated population. Keratotic lesions (i.e. AK lesions and warts) in this     population is highly associated with development of SCC also with 10 times higher mortality     rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and     BCC, increases with graft survival time and the length of immunosuppressive treatment period.      The higher risk of developing skin malignancy and more aggressive skin malignancies in this     population, indicate the need for early removal of these pre-malignant lesions.      In this study, two contralateral areas (5x10 cm2) with skin lesions within the patient will     be compared. One area will receive Metvix PDT at defined intervals and the other will receive     lesion specific treatment at the discretion of the investigator. The primary end-point will     be the accumulated number of new lesions during the study and number of AK lesions that show     complete response 3 months after baseline. Secondary endpoints will be number of BCC lesions     that show complete response, number of recurrent lesions, assessment of cosmetic outcome and     safety.   "
201038|NCT00472472|"     The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the     efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis     after femoropopliteal angioplasty.   "
201039|NCT00472485|"     The purpose of this study is to determine the ability of several eye movement monitors, used     in clinical practice, to identify children with poor reading eye movements. A second purpose     of the study is to evaluate the effectiveness of eye movement therapy.   "
201040|NCT00472498|"     The central purpose of this study is to compare the clinical outcomes of patients who     suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic     defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac     arrest before 2001.   "
201041|NCT00472511|"     Attention-Deficit Hyperactivity Disorder (ADHD) is considered to be one of the most prevalent     chronic health conditions in children. It affects between 4% and 12% of young children. A     relationship between convergence insufficiency (eye teaming) and ADHD has been shown.     However, the effect of ADHD medications on focusing and eye teaming has not been previously     investigated. Therefore, the purpose of this study is to determine the effect of ADHD     medication on focusing and eye teaming skills.   "
201043|NCT00472537|"     This purpose of this study is to compare the recovery after an operation of an incisional     hernia within the limits of the rectus muscles of the abdominal wall. The use of a mesh in     the repair of a postoperative hernia is considered obligatory. Placement of a retromuscular     mesh is done by open or laparoscopic surgery. Focus is on the recovery phase assuming a less     painful recovery after a laparoscopic procedure.   "
201052|NCT00472654|"     The purpose of this study is to learn how the amount of vitamin D supplementation influences     intestinal fractional calcium absorption (a measure of the amount of calcium absorbed).   "
201053|NCT00472667|"     The study is a prospective, randomized, controlled intervention trial conducted in 9 centers,     comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue     antibiotics, in patients with suspected community or hospital- acquired infection.   "
201044|NCT00472550|"     To investigate the effect of 20 mg esomeprazole daily for one week on gastric emptying of 500     ml beer, the consecutive blood alcohol levels, the gastroesophageal reflux and plasma levels     of gastrin and CCK in a randomized, placebo-controlled, double-blinded manner in 16 healthy     male volunteers.      Hypothesis:      The combined taking of esomeprazole and beer will inhibit gastric emptying as compared to the     intake of beer alone. This will induce a delay of the ethanol absorption and of the     consecutive blood ethanol concentrations. Gastric acid secretion after beer will be reduced     after esomeprazole treatment. Therefore, gastroesophageal acid reflux will be reduced after     the combined taking. We speculate that gastrin, but not CCK plasma levels, will be increased     after the combined taking as compared to beer alone. Both, beer and PPIs, have stimulatory     effects on gastrin release. However, the secretion of CCK from duodenal CCK-cells is     inhibited when gastric emptying is prolonged.   "
201045|NCT00472563|"     Deterioration of kidney renal function occurs in a minority of people due to     contrast-required procedures. The purpose of this study is to compare two different     interventions to reduce the risk of kidney injury after contrast medium exposition.      We will perform a randomized clinical trial following a modification of a previously     published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly     assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline     infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will     receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip     rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.   "
201046|NCT00472576|"     Purpose : This study will determine whether MK-0657, a selective NR2B Antagonist, can quickly     improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced     enjoyment of things in patients with major depression.      MK-0657 decreases the activity of a brain receptor called NMDA, which the chemical glutamate     binds to, possibly inducing a rapid antidepressant response. People between 18 and 55 years     of age who have major depression of at least 4 weeks' duration and have not been helped by     two antidepressants approved for major depression may be eligible for this study. Women who     are able to have children are excluded. Participants are admitted to the NIH Clinical Center     for two study phases, as follows. Phase I (1 to 2 weeks): Patients are tapered off their     current medications. Phase II (7 weeks): Patients are randomly assigned to take either     MK-0657 or placebo (look-alike capsules with no active ingredient) by mouth for 12 days. At     some point during the second part this phase, patients who had been taking MK-0657 are     switched over to placebo and those who had been taking placebo are switched to MK-0657.     Participants undergo the following procedures during the study:Physical examination twice (at     the beginning and at the end of the study) Electrocardiogram (ECG) four times Blood tests     about six times Rating scales up to 28 times to assess the effects of MK-0657 on mood and     thinking Blood pressure measurements three times a day.      Study examines the effectiveness of a new medication, targeting a system called glutamate,     will improve depression when compared with placebo.   "
201047|NCT00472589|"     The purpose of this trial is to collect plasma, serum, whole blood and tissue samples from     women with breast cancer and plasma, serum, whole blood from healthy women, which will be     made available to researchers for biomarker analysis.   "
201048|NCT00472602|"     Opisthorchis viverrini (OV) is a parasite that individuals get from eating raw fish.     Infections with this parasite have been associated with liver abnormalities that sometimes     lead to bile duct cancer. The purpose of this study is to find out how many people in several     areas of the Khon Kaen province are infected with OV, what affect this parasite has on the     liver, how the immune system reacts to infection with this parasite, and how the liver is 12     months after being treated for this parasite. Study participants will include 6,000     volunteers, ages 20-60, living in villages surrounding Khon Kaen that have large numbers of     people infected with OV. Study procedures will include a stool sample, an ultrasound (sound     waves bounced off internal organs to create a picture), and a blood sample. Individuals found     to test positive for the parasite will be treated at their local primary health care unit.     Participants will be involved in study procedures for up to 12 months.   "
201049|NCT00472615|"     Background and Rationale for Study: Estrogen and progesterone are female hormones that     regulate the menstrual cycle and likely serve an important role in the regulation of mood.     Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild     dysphoria and physical discomfort that begin 1-2weeks pre-menses, and resolve by 2-3 days     post-onset of menses. Up to 66% of women with bipolar disorder (BD) describe premenstrual     mood changes that range from mild symptoms to severe worsening that require hospitalization.     Therefore, the hormonal shifts of the menstrual cycle likely influence bipolar symptoms, but     confirmatory research is lacking.      Study questions: The primary aims and hypotheses are to characterize bipolar mood symptoms     throughout the menstrual cycle and to determine if women with BD have: 1) a) increased     severity and persistence of depression and mania symptoms in the late luteal (premenstrual)     vs early follicular phase, b) larger change in mood symptoms from the late luteal     (premenstrual) to the early follicular phase, compared to healthy women, 2) more relapses, in     the late luteal compared to the early follicular phase. The secondary aims are to determine:     1) frequency and severity of premenstrual dysphoric disorder (PMDD) type symptoms in bipolar     women; 2) association between bipolar mood variability and a) menstrual phase, b) ovulatory     vs anovulatory cycles, c) antimanic drug treatment.   "
201050|NCT00472628|"     The purpose of the study is to procure blood samples from patients ≥18 years of age who     present to the Emergency Department (ED) with at least two of the diagnostic criteria for     sepsis. Samples obtained upon enrollment will be used for future testing of the Triage Sepsis     Panel and other biomarkers.   "
201069|NCT00472875|"     To see if using medication called sulphonylureas can help improve symptoms which patients     rely on to recognise low blood glucose levels ( hypoglycaemia) and also to see if they can     reduce the slowing down in brain function which occurs at hypoglycaemia.   "
201051|NCT00472641|"     This research study is designed to determine if replacing your current antipsychotic and/or     mood stabilizer with ziprasidone (Geodon) will impact weight. This research is being     conducted because Geodon has a documented effect on mood. Additionally, we believe Geodon to     be an effective medication for overweight or obese patients with bipolar disorder. There will     be approximately 25 patients enrolled in this study.   "
201057|NCT00472719|"     The purpose of this study is to determine the safety of and immune response to an     experimental DNA HIV vaccine followed by boosting with either an experimental adenoviral     vector HIV vaccine of serotype 5 or 35 in HIV uninfected adults. This study will also     determine the safety of and immune response to an adenoviral vector HIV vaccine of serotype 5     followed by a booster of an adenoviral vector of serotype 35, or vice versa, in HIV     uninfected adults.   "
201058|NCT00472732|"     Urea cycle disorders (UCDs) are a group of rare inherited metabolism disorders. The purpose     of this study is to evaluate how UCD-related neurologic injuries affect adults with one of     the most common types of UCD.   "
201059|NCT00472745|"     The purpose of this study is to determine the effect of weight loss on bone health in men.   "
201060|NCT00472758|"     -To evaluate the safety and tolerability of a multiple doses of this drug in adult patients.   "
201061|NCT00472771|"     The purpose of this study is to determine whether INNO-206 is effective in the treatment of     small cell lung cancer.   "
201062|NCT00472784|"     OBJECTIVE: 1. To study tissues from spinal cord injured patients with noncompliant bladders     as well as neurologically intact patients with normal bladder compliance, analyzing both     quantitative and qualitative neural efferent receptors, collagen, and smooth muscle contents,     using RT-PCR and electron microscopy. 2. To explore the possible shift in bladder neural     architecture after SCI from beta to alpha-adrenergic receptors.      RESEARCH DESIGN: 25 spinal cord injury patients who underwent cystoscopic procedures will be     included in this study. 25 control patients without spinal cord injury and already scheduled     for urologic procedures will also be included in this study.      METHODOLOGY: Study patients will undergo flexible or rigid cystoscopy as well as selective     cold cup biopsies of the posterior and lateral walls, and trigonal area of the bladder.     Control patents will undergo cystoscopy and selected bladder biopsies preceding their     scheduled urologic procedures. Tissue samples will be frozen for later EM and RT-PCR analysis     of collagen, smooth muscle, and efferent adrenergic receptor content and subtype. Hemostasis     will be achieved with a cautery electrode. Criteria of exclusion include active urinary tract     infection identified by preoperative urinalysis, or the presence of suspicious lesions seen     during cystoscopy. Suspicious areas will be biopsied and the patient will be excluded from     the study.      Subjects will be given a preoperative dose of Rocephin 1g IM as well as a postoperative 3-day     course of Cipro 500 mg BID. Control patients will be given standard perioperative     prophylactic/empiric therapy as indicated for their urologic procedure. Patients will be     followed in 1-2 weeks to evaluate their postoperative course.      FINDINGS: Total number of subjects enrolled: 43. 12-03: To date we have not encountered any     problems with the study and health wise the subjects have done fine. No adverse events have     been reported. Preliminary Results: The tissue is currently being analyzed - mRNA by     microchip analysis and the data is still being worked on to look for correlations in genes up     or down regulation versus the morphological EM findings previously reported.   "
201063|NCT00472797|"     To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and     injection site redness Rebif treated subjects with relapsing forms of MS who transition to a     new formulation of Rebif (RNF).   "
201064|NCT00472810|"     The purpose of this study is to compare the safety and effectiveness of the ologen     (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.   "
201065|NCT00472823|"     The purpose of this study is to examine the effects of several doses of vitamin D on hormones     related to bone, calcium absorption, bone density and muscle strength.   "
201066|NCT00472836|"     CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal     (kidney) function can affect their elimination from the body via metabolism. This study will     therefore compare the pharmacokinetics (time course of drug concentrations in the body),     safety and tolerability of CP-945,598 in patients with severe renal impairment and healthy     control subjects.   "
201067|NCT00472849|"     The goal of this clinical research study is to find the highest tolerable dose of fludarabine     and cytarabine that can be given in combination with oxaliplatin and rituximab in the     treatment of chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, or Richter's     transformation. Once the highest tolerable dose for this drug combination is found, the next     goal of the study will be to find out if this combination therapy is effective in shrinking     or slowing the growth of these diseases.   "
201068|NCT00472862|"     The study examines the effect of cognitive training on cognitive functioning and everyday     competencies of patients with schizophrenia.      120 patients are expected to be included in this randomized controlled trial running at two     sites in Denmark starting January 2007 The effect of a 16-week, manualized program of     cognitive training integrated in a comprehensive psychosocial treatment (OPUS) for     first-episode schizophrenia patients is compared with the effect of standard treatment     (OPUS). A six month follow-up assessment is conducted to investigate a possible long-term     learning effect of cognitive training.      Blinded assessments include the MATRICS Consensus Cognitive Battery and a co-primary outcome     measure of cognitive improvement: A translated version of the UCSD Performance-based Skills     Assessment (UPSA) adjusted to a Danish context.      The cognitive training consists of four modules focusing on the domain of attention,     executive functioning, learning and memory. Module 1 and 2 are based on computer-assisted     training tasks, and the following modules focus on more practical everyday tasks and calendar     training. Cognitive training takes place twice a week and every other week the patient and     trainer engage in a dialogue on the patient's cognitive difficulties, motivational goals and     his/her progress in competence level.      The use of errorless learning principles, scaffolding and attentional externalisation aims at     improving the patients' performance on cognitive and everyday tasks by learning to apply     compensation techniques as well as limiting dysfunctional uses of available cognitive     ressources (i.e. excessive self-focus, rumination).      The study will provide MATRICS Consensus Cognitive Battery results from a relatively large     Danish sample of first-episode schizophrenia and contribute with valuable normative data on     the UPSA.      It is hypothesized that cognitive training integrated in OPUS treatment enhances both     cognitive and everyday competence of patients more than OPUS treatment alone. Expectations     are that cognitive training will demonstrate a small to moderate effect on cognitive     functioning and a moderate effect on everyday functioning as measured with the UPSA.     Moreover, patients allocated to cognitive training are expected to show an improvement in     self-esteem.   "
201071|NCT00472901|"     The purpose of this study is to determine whether the afamelanotide (CUV1647) formulation is     effective in preventing PLE episodes or reducing the severity of PLE symptoms in patients     with a well documented history of the disease. The study also aims to determine whether     treatment with afamelanotide (CUV1647) can reduce the use of rescue medication in this group.   "
201072|NCT00472914|"     A handheld surface electromyography device will be tested by clinicians on children with limb     hypertonia, and inter-rater reliability will be assessed with and without the device.   "
201073|NCT00472927|"     To evaluate three new investigational tablet formulations of the Food and Drug Administration     (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).   "
201074|NCT00472940|"     Cancer and its complications are common problems. In most cases, this condition has a     profound impact on survival and quality of life (QoL). Fatigue, sexual dysfunction, decreased     sexual drive, depression and poor appetite are commonly seen in these patients. However,     these symptoms also are seen in men with other conditions including those with low     testosterone levels.      The objective of this study is to determine the number of male patients with cancer that have     low testosterone levels and to establish the relationship between testosterone levels and the     symptoms that these patients experience.   "
201075|NCT00472953|"     This trial is conducted in Europe, Asia and South America. A one-year clinical trial to     compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with     type 1 or type 2 diabetes and chronic obstructive pulmonary disease (COPD).   "
201076|NCT00472966|"     To determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a     series of Glycolic Acid peels in treatment of moderate to severe melasma.   "
201077|NCT00472992|"     The primary objective of the Registry was to evaluate the outcomes of pregnancy in women with     Multiple Sclerosis (MS) or Crohn's Disease (CD) who were exposed to TYSABRI® at any time     within 90 days prior to first day of Last Menstrual Period (LMP) or during pregnancy.   "
201078|NCT00473005|"     In order to improve the survival of metastatic breast patients, it is important to     investigate the use of novel therapeutic agents combined with known active agents in the     treatment of breast cancer. This is a phase I study evaluating the maximum tolerated doses     and toxicities of RAD001 in combination with capecitabine for the treatment of metastatic     breast cancer. RAD001 (INN: everolimus) is a novel macrolide, which is being developed as an     antiproliferative drug with applications as an immunosuppressant and anticancer agent. Phase     I trials in patients with solid tumors have shown that treatment with RAD001 is     well-tolerated with a minimal side effect profile. Capecitabine (Xeloda, Roche) is an oral     fluoropyrimidine that was approved in 1998 for the treatment of patients with metastatic     breast cancer. The all-oral regimen of RAD001 with capecitabine is an attractive approach as     the treatment of metastatic breast cancer has not yet proven to be curative. We also want to     find out what possible benefit this combination of drugs might have on treating your cancer.   "
201079|NCT00473018|"     This is a randomized trial to compare the effect of standard versus enhanced risk reduction     counseling on risk behavior incidence in individuals receiving PEP medications. The study     seeks to 1) determine if there are equivalent changes in the incidence of self-reported risk     behaviors, STD incidence, and adherence to medications in individuals who receive enhanced     risk reduction and adherence counseling and those who received standard risk reduction and     adherence counseling; 2) evaluate viral and host biological factors involved in sexual     transmission that may either influence PEP efficacy, or themselves be negatively or     positively affected by the administration of PEP medications; and 3) contribute to the CDC     registry in an attempt to provide crucial data for a case control analysis to establish the     efficacy of PEP for sexual and injection drug use exposures. The principal outcome will be     the change in participants' number of unprotected sexual acts following administration of     PEP. This is defined as the number of prior 3-month acts of high risk unprotected sex,     assessed at 12 months following a course of PEP, minus the number of unprotected acts the     participant reported in the 3 and 6 months prior to beginning PEP (assessed at baseline).     Methods to be used consist of interview data collection, questionnaires, risk reduction and     adherence counseling and source recruitment counseling (index subject).   "
201080|NCT00473031|"     The purpose of this study is to learn how the amount of protein during moderate weight loss     influences bone health.   "
201081|NCT00473044|"     The purpose of this study is to investigate whether a faith-based curriculum delivered in     small groups, and emphasizing goal setting along with mutual responsibility, increases     physical activity.   "
201082|NCT00473057|"     This is a open label study to assess the safety of autologous bone marrow transplantation in     patients with a ischemic stroke in the middle cerebral artery territory within 90 days from     symptoms onset.   "
201083|NCT00473070|"     The purpose of this study is to determine the amount of study medication that moves from the     front of the eye into the fluid at the front of the inside of the eye.   "
201084|NCT00473083|"     The purpose of this trial is to determine if rash caused by erlotinib can be successfully     treated and if so to determine the optimal treatment approach.      Hypothesis:      Hypothesis 1: If the incidence of rash is 50% while on erlotinib, prophylactic monotherapy     with minocycline can prevent occurrence in 50% of these patients.      Hypothesis 2: Treatment of rash is successful in improving rash by at least one Grade in 80%     of patients.      Hypothesis 3: In patients with untreated rash, the rash will be self-limiting in 25% of     patients, and 65% will be grade 1, 2A, and 2b. Ten percent will be grade 3 requiring     treatment with monotherapy intervention.   "
201085|NCT00473096|"     The purpose of this study is to develop and test an informative computer-based program to     help women in making good choices among options for treating early stage breast cancer. Women     who are exposed to the computerized program will, when compared to women who receive standard     of care offered at the hospital: (a) be more knowledgeable about treatment options,(b) be     more satisfied with their treatment decision, and (c) be more assured about their treatment     choice.   "
201139|NCT00483665|"     After endovascular treatment of an abdominal aortic aneurysm, lifelong imaging follow-up is     needed to monitor the effectiveness of the treatment. One parameter in this follow-up is     endoleak, which is leakage of blood into the aneurysm sac. The aim of this study is to     investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for     the detection of endoleaks.   "
201086|NCT00473109|"     Conventional hemodialysis requires transient systemic anticoagulation to prevent blot     clotting after contact with the extracorporeal circuit. However, low molecular weight heparin     (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for     hemorrhagic complications. In this setting, several procedures theoretically allow dialysis     without systemic heparinization, but randomized studies to compare them are lacking. The gold     standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (     rises ). Two emerging procedures are increasingly used : continuous pre-dilution of the     arterial line ( pre-dilution ) and the use of a specific dialysis membrane (NEPHRAL 400 ST)     coated with heparin immediately before use ( heparin adsorption ).   "
201087|NCT00473122|"     The goal of this clinical research study is to evaluate a new two-stage approach     (delayed-immediate reconstruction) to breast reconstruction in women who may require     post-mastectomy radiation therapy. Researchers will compare the cosmetic outcomes and any     complications that occur in women who receive delayed-immediate reconstruction to those who     receive the standard approaches (either immediate reconstruction or delayed breast     reconstruction).   "
201088|NCT00473135|"     Dengue fever, caused by dengue viruses, is a major health problem in tropical and subtropical     regions of the world. The purpose of this study is to evaluate the safety of and immune     response to a 2-dose regimen of a new monovalent dengue virus vaccine. This study will test     the dengue virus vaccine DEN1delta30 in healthy adults.   "
201089|NCT00473148|"     Several clinical findings and clinical trials have suggested that the prognosis of intensive     care unit (ICU) patients may be improved by minimizing the positive fluid balance. In     particular, a global vascular overload could lead to weaning failure. The purpose of this     international, multicenter, controlled, randomized trial is to test if the incorporation of a     B-type natriuretic peptide (BNP) assay in a mechanical ventilation weaning protocol helps     optimize the weaning process and reduce the duration of the ventilatory weaning period.   "
201090|NCT00473161|"     A newly-developed device for biofeedback of surface EMG will be used to either increase or     decrease activity in the muscles of children with poor reaching due to cerebral palsy.   "
201091|NCT00473174|"     This prospective chronotherapy trial will investigate the potential differing efficacy of     ramipril in doses from 5 to 10 mg/day when administered, as a monotherapy either upon     awakening from nighttime sleep or at bedtime, to diurnally active patients with grade 1 or 2     essential hypertension, who will be evaluated by 48-hour ABPM before and after pharmacologic     intervention. The benefits from this trial may be extremely important, taking into account        1. the high prevalence of non-dipping among patients with essential hypertension        2. the need for a proper 24-hour BP control with particular emphasis on the regulation of          nighttime resting BP mean        3. the lacking information on the administration-time dependent effects on BP of ramipril,          a widely used ACEI in doses of 5-10 mg/day.   "
201092|NCT00473187|"     X-linked hypophosphatemic rickets (XLH) is characterized by rickets, disproportionate short     stature, impaired renal phosphate reabsorption and vitamin D metabolism. Despite oral     phosphate and vitamin D treatment, most children with XLH demonstrate reduced adult height.     The main objective of the study is to determine the beneficial effects of recombinant human     growth hormone (rhGH) therapy on body proportions after 36 month in these patients. Secondary     objective is to monitor side effects of the therapy.   "
201093|NCT00473200|"     The purpose of this study is to investigate whether S-adenosylmethionine (SAMe), a natural     substance available as a nutritional supplement, can influence blood levels of homocysteine     (Hcy). More specifically, we will determine if chronic oral SAMe administration affects     homocysteine metabolism in patients with vascular disease who have mild to moderate     hyperhomocysteinemia.   "
201094|NCT00473213|"     BetaferonR is effective in reducing relapse rate and MRI T2-weighted lesion frequency in MS     patients at the dose of 8 MIU on alternate days (THE IFNB MS Study Group, 1993). Relapse rate     is reduced by 30-35% (The IFNB MS Study Group, 1993), MRI activity is decreased up to 100% in     most cases (Stone et al 1995). In some patients, however, MRI activity still occurs or     reappears during treatment (Stone et al 1995). MRI activity has been demonstrated to     correlate with relapse occurrence (McFarland et al, 1992; Miller et al, 1996), and in some     patients relapses still occur during IFN beta treatment. In other patients relapses may occur     in association with the appearance, after 9-18 months of treatment, of anti-IFN beta NAB (The     IFNB M S Study Group, 1995).      This protocol hypothesizes that the dose of 12 MIU BetaferonR on alternate days has more     pronounced MRI and clinical effects in MS patients than that of 8 MIU. MS patients who do not     respond to 8 MIU may take advantage of a higher dose. We, therefore decided to assess MRI     effects after increasing the Betaferon dose (12 MIU) in RRMS patients showing a residual MRI     activity (at least one new Gd enhancing lesion) during six months of standard Betaferon dose     treatment (8 MIU).   "
201095|NCT00473239|"     When people eat a meal, some, but not all of the calcium in that meal is absorbed, that is,     moved into the bloodstream. When the skin is exposed to sunlight during summer months,     Vitamin D is made there and then modified into more active forms by the liver and kidneys.     These more active forms of Vitamin D improve calcium absorption. Many adults living in the     U.S. have little or no sun exposure and are low in Vitamin D. A single dose of 100,000 IU of     Vitamin D3 has been used both as empiric treatment for Vitamin D deficiency as well as in     controlled trials without risk of raising blood calcium to dangerous levels.This study is to     determine the serum levels of Vitamin D and 25-hydroxyvitamin D (vitamin D after it has been     modified by the liver) that can be expected when Vitamin D3 is given as a single oral dose of     100,000 IU.   "
201096|NCT00473252|"     Fungal infections in immunocompromised patients occuring during construction activities in     hospitals have repeatedly been reported.      However, the question of a causal relation between construction activities and infections has     never been addressed systematically and prospectively.      To answer this question, we will monitor our immunosuppressed patients' health status, as     well as fine dust and aspergillus spore contents in the air during a three year construction     activity period in our hospital.   "
201140|NCT00483678|"     RATIONALE: A couples therapy program may enhance intimacy and reduce psychological distress     in patients with prostate cancer and in their partners.      PURPOSE: This randomized clinical trial is studying how well couples therapy enhances     intimacy and reduces psychological distress in patients with advanced or recurrent prostate     cancer and in their partners.   "
201120|NCT00479518|"     Patients with stroke or transient ischemic attack (TIA) are at high risk of poor outcome,     recurrence of cardiovascular events or vascular death.Until now, no reliable predictive     biological marker could be identified in the acute phase of stroke.We hypothese that, in the     acute phase of ischemic stroke or TIA, the increase of cardiac ( brain natriuretic peptide,     BNP) or renal markers (albuminuria, cystatin C)might predict recurrence of cardiovascular     events or vascular death. We want to assess which one of these markers has the best prognosis     value , in a prospective study of 300 stroke patients followed during 3 years.   "
201121|NCT00479531|"     The purpose of this study is to determine if sequential compression devices (SCD) when worn     for an hour per day by patients suffering from Restless Legs Syndrome (RLS) are helpful for     the improvement of the RLS symptoms and sleep.   "
201122|NCT00479557|"     To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active     immunization, in patients with mild to moderate Alzheimer's disease.   "
201097|NCT00473265|"     Whereas much information is known about the properties of bone in primary     hyperparathyroidism, a disorder of parathyroid hormone (PTH) excess, virtually nothing is     known about the skeleton in hypoparathyroidism, a disorder in which PTH is absent. The     purpose of this research project is to test the hypothesis that the skeleton in     hypoparathyroidism is abnormal in its metabolic, densitometric, geometric, biomechanical and     microarchitectural features. We will also test the hypothesis that the skeleton is dependent     upon PTH for normal structure and function. Using non-invasive approaches as well as direct     analysis of bone itself, the human hypoparathyroid skeleton will be thoroughly characterized.     With each patient serving as his/her own control, we will determine how, to what extent, and     in what ways the administration of PTH restores skeletal dynamics and structure to the     hypoparathyroid skeleton. In this way, we will identify those structural and dynamic elements     of the skeleton that are influenced by or dependent upon PTH. Methods to be utilized include     dual energy X-ray absorptiometry, quantitative central and peripheral computed tomography,     geometry and size quantification, histomorphometry by standard and microCT methods, finite     element analysis, biochemical bone markers, quantitative back scattered electron imaging, and     Fourier Transform Infrared Spectroscopy. This research project will extend our knowledge of     the skeletal effects of PTH to its deficient range and thus complete our understanding of PTH     action on bone gained by our many years of studying PTH overexpression in primary     hyperparathyroidism. This investigation may also provide insight into the means by which PTH     helps to restore the skeleton when it is used to treat osteoporosis.   "
201098|NCT00473278|"     The significance of our study is in the importance of understanding the quality and quantity     of proteins in the human tear film, and any unique aspects of tears in children. This pilot     study will provide data to plan prospective research to better delineate the utility of tear     proteins in diagnosing and following disease status in a non-invasive fashion.   "
201099|NCT00473291|"     The primary purpose of this study is evaluate the VRI device's accuracy in diagnosis of     pleural effusion (in comparison to chest x-ray and ultrasonography), and to assess the     pleural effusion location and size. The VRI system uses pressure sensors (electronic     stethoscopes) to record the energy created by the airflow in the lungs during breathing.   "
201100|NCT00473304|"     To evaluate the safety, efficacy and physiological performance of daily disposable spherical     and toric soft contact lenses in a vision-corrected population of children ages 8-11 years of     age. To evaluate the ability of the practitioner to fit these lenses and for the children to     wear and manage these lenses.   "
201101|NCT00473317|"     When people eat a meal, some, but not all of the calcium in that meal is absorbed, that is,     moved into the bloodstream. When the skin is exposed to sunlight during summer months,     Vitamin D is made there and then modified into more active forms by the liver and kidneys.     These more active forms of Vitamin D improve calcium absorption. Many adults living in the     U.S. have little or no sun exposure and are low in Vitamin D. We know that specific     wavelengths of sunlight called Ultraviolet-B cause Vitamin D to be made in the skin.   "
201102|NCT00473330|"     This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled     study of the efficacy and safety of ranibizumab injection in patients with clinically     significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus     (Type 1 or 2). This study is identical in design to study NCT00473382 (Protocol ID FVF4168g).      The open-label extension phase of the study was stopped after receiving FDA approval of the     study drug (ranibizumab) for diabetic macular edema.   "
201103|NCT00473343|"     Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light     activation of a photosensitiser in the presence of oxygen. These cells accumulate more     photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon     illumination.      For skin diseases, there has been an increasing interest in using precursors of the     endogenous photoactive porphyrins. The most commonly used precursors have been     5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contains the     methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity .      BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all     non-melanoma skin cancers . It is the most common cancer in humans . Several     non-pharmacological treatment modalities are used for BCC, including excision surgery,     curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation     therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on     the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good     response rates in the majority of patients but are inadequate in a small group of patients     defined as high-risk BCC.      In this particular patient group, even a moderate complete response rate with good cosmetic     results may be considered beneficial, since the number of patients who have to receive more     advanced therapy with the possibility of high morbidity and poor cosmetic outcome will be     reduced. Even a partial response is of clinical interest since the remaining tumour will     require less extensive surgery. In the case of treatment failure, Metvix PDT does not     interfere with the use of other treatment modalities.      The variable complete response after one or two Metvix treatment cycles will be used as the     basis for the justification of sample size. The following hypothesis will be tested:      H0: Complete response rate of Metvix is less or equal to 65 % versus the alternative     hypothesis HA: Complete response rate of Metvix is greater than 65 %   "
201104|NCT00473356|"     The Focus of this study is to look at the role of nutrition in maintaining lean body mass     post-gastric bypass surgery. The purpose of this study is to test whether LBM is increased in     those patients receiving a nutritional supplement of amino acids is enhanced when compared to     control patients not receiving the supplement.   "
201105|NCT00473369|"     Context: Pituitary adenoma is generally indolent, but an aggressive subtype called atypical     adenoma has uncertain prognosis, and an unclear relationship between prognosis and     morphology.      Objective: This study investigated the prognostic factors of this tumor. Design:     Retrospective analysis. Setting: University and associated hospitals.   "
201106|NCT00473382|"     This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled     study of the efficacy and safety of ranibizumab injection in patients with clinically     significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus     (Type 1 or 2). This study is identical in design to study NCT00473330 (Protocol ID FVF4170g).      The open-label extension phase of the study was stopped after receiving FDA approval of the     study drug (ranibizumab) for diabetic macular edema.   "
201107|NCT00473408|"     The purpose of the current trial is to explore whether the standard treatment with     radiotherapy and temozolomide affect the tumor vasculature in patients with high-grade     astrocytomas. If vascular effects are identified, future clinical trials can be proposed     wherein anti-angiogenic agents are added to increase patient survival.   "
201860|NCT00483249|"     This is a study to assess the safety and effectiveness of endovascular treatment of     thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The     investigational operation involves placing a stent-graft over the aortic aneurysm.   "
201108|NCT00473421|"     Joint replacement is a well-documented and cost effective treatment of degenerative diseases     in the hip (1,2). There are two different principles of fixation of prosthesis components;     cemented and uncemented. The most common mode of fixation in Scandinavia has historically     been with bone cement. In the recent years a reverse hybrid combination (uncemented stem and     cemented cup) is gaining popularity, especially in Norway.      Beside luxation, infection and venous thromboembolism, the problem with aseptic loosening is     a known complication. A marker for aseptic loosening is local bone loss around the     components. This is measured with a densiometer and the method is Dual Energy X-ray     Absorbtiometry (DXA). Periprosthetic bone loss is evaluated by series of DXA scans around the     components over time. This enables us to follow changes in bone mineral density (BMD) close     to the prosthesis.      We want to compare cemented and uncemented prostheses with this technique. This is a problem     since we don’t know how much different contrast medias in bone cement affect DXA scans. This     area is poorly investigated. Attempts have been made to exclude the cement-mantle from the     measurements both digitally and manually, but these have showed poor precision. A kind of     consensus of assuming that contrast medias in bone cement give an increase in measured BMD of     20% (4). This is used when comparing cemented and uncemented components.      We have preformed laboratory tests of different cements. Zirconium oxide (ZrO2) and Barium     sulphate (BaSO4) are used as radiopacifiers. These contrast medias have different properties.     Our test showed that Zirconium give 63% higher BMD when we scanned cement alone.      This is supported by a cadaver study showing significant differences between contrast free     cement and ZrO2 /BaSO4 containing cements.      It is our opinion that it is necessary to perform a prospective study to investigate this     more thoroughly.      The hypothesis of this study is that it is not accurate enough to add 20% in BMD for cemented     implants when comparing them with uncemented implants. It is probably necessary to take into     account the amount of cement used and kind of contrast medium.   "
201109|NCT00473434|"     The purpose of this trial is to evaluate the dose distribution, effectiveness and safety in     patients with schizophrenia who are switched from an oral atypical antipsychotic to     Paliperidone ER. In this study patients and physicians know the name and the dose of the     study drug. Newly diagnosed patients will also be included in the study. In general, the     recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a     higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can     be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was     chosen to best mimic actual clinical practice.The safety assessments to be conducted     throughout this study including the regular monitoring and recording of all Adverse Events     and Serious Adverse Events.   "
201110|NCT00479362|"     There are no established guidelines regarding interruption of warfarin anticoagulant therapy     prior to surgical implantation of cardiac pacemakers. Continuing the anticoagulant could     potentially result in increased bleeding complications from the implantation surgery, whereas     discontinuing the anticoagulant could predispose the patient to blood clots and strokes. In     this study we intend to randomly assign warfarin-treated patients either into interrupted or     continued warfarin therapy prior to pacemaker implantation with the purpose of establishing     the rate of complication in these groups. Our hypothesis is that a cardiac pacing device can     be safely implanted without discontinuation of the anticoagulant therapy.   "
201111|NCT00479375|"     Human papillomavirus (HPV)-based cervical screening is known to increase sensitivity for     detection of high-grade cervical intraepithelial neoplasia (CIN). Randomized trials of     longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a     protective effect.      Methods: A total of 12527 women, aged 32-38, attending population-based invitational     screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or     cytology only (control arm). HPV-positive women were invited for a second HPV test at least     one year later and women with type-specific persistent infections were then invited to     colposcopy. A similar number of random double-blinded procedures are performed in the control     arm. Women are followed with comprehensive registry-based follow-up. Primary outcome is the     relative rates of CIN grade 2 or worse (CIN2/CIN3+) found in subsequent screening. Secondary     outcomes are the relative rates of CIN2/CIN3+ found in the aseline screening and outcomes     stratified by grade of CIN (CIN 2 or CIN3+).   "
201112|NCT00479388|"     This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed     dyslipidemia to study the effects of ER niacin/laropiprant on lipids.   "
201113|NCT00479401|"     The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to     determine the efficacy (as measured by the change from baseline to the end of the maintenance     phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II     and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily     doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority     between the two formulations (ER and IR) of pramipexole.      In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo,     for assay sensitivity   "
201114|NCT00479427|"     This is a double-blind, two-period, placebo controlled cross-over Phase IIa study. This study     is to use CB2 compound of GW842166 in patients with osteoarthritis. The pain assessments and     WOMAC questionnaires will be used in the study after the repeated dose to evaluate the     efficacy of CB2 compound of GW842166.   "
201115|NCT00479440|"     To assess the safety and tolerability of ascending single oral doses of SAM-315, an     investigational drug, in healthy adult subjects. To obtain a preliminary pharmacokinetic (PK)     and pharmacodynamic (PD) profiles of SAM-315 in healthy subjects and to evaluate the effect     of a high-fat meal on the PK of SAM-315, an investigation drug, administered to healthy adult     subjects.   "
201116|NCT00479466|"     A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes     Mellitus).   "
201117|NCT00479479|"     Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in     infants. We have earlier investigated cobalamin status in healthy children and we observed     metabolic evidence of impaired cobalamin status during the first 6 months, but not later in     life.      The purpose of this study is to determine if cobalamin supplementation may influence the     metabolic profile related to cobalamin status in infants.   "
201118|NCT00479492|"     The purpose of this study is to determine whether CP-866,087 is effective in the weight loss     of overweight patients.   "
201119|NCT00479505|"     This is a 12 week study in which different doses of UK-369,003 will be administered to     patients with a diagnosis of overactive bladder. Patients will complete a series of     questionnaires before treatment, during treatment and after treatment, to assess whether     UK-369,003 has improved their symptoms of overactive bladder and erectile function.   "
201141|NCT00483691|"     1. Children in the home intervention group will have better growth (increase in weight and          height) than children in the control group.        2. Children in the home intervention group will have better behavior than children in the          control group.        3. Children in the home intervention group will have better academic performance than          children in the control group.   "
201125|NCT00479596|"     The current study will investigate the comparative efficacy, safety and patient satisfaction     of intradetrusor injections BOTOX® injections (200U) versus placebo (saline) injections in     the treatment of OAB secondary to benign prostatic obstruction (BPO).   "
201126|NCT00479609|"     Men with metabolic syndrome often have lower than normal testosterone levels and low     testosterone levels have been suggested to predispose for development of type2 diabetes. The     aim of the study is to evaluate if normalisation of serum testosterone levels in men with     metabolic syndrome (Abdominal obesity, hypertension, dyslipidemia, insulin resistance and     pre-diabetes or overt type diabetes)improves sensitivity to insulin and improves the signs of     the metabolic syndrome   "
201127|NCT00479622|"     The purpose of this study is to determine how the body absorbs and chemically changes a     single infusion of TRU-015 in subjects with kidney disease caused by lupus.   "
201128|NCT00479635|"     The primary objective of the study is to determine the response rate to TPI 287 in patients     with metastatic, hormone-refractory prostate cancer who have had one prior taxane regimen.   "
201129|NCT00479648|"     Current influenza vaccines have a reduced efficacy in the elderly. This study will     investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in     elderly participants.   "
201130|NCT00479661|"     Patients in the ICU who need help with their breathing are put onto a machine called a     ventilator and are also given a medicine, called a sedative, which helps them to sleep and     makes them more comfortable. Propofol is a sedative that is routinely used for these     purposes.      For most patients the aim of sedation is to make them sleepy but still able to respond to     nursing staff (light sedation).      Dexmedetomidine is a new sedative for use in intensive care and in this clinical     study,dexmedetomidine is compared to propofol. It is thought that dexmedetomidine might be     slightly better at allowing patients to be sleepy but still respond to people around them. It     also does not appear to affect patient's breathing. The purpose of this study is to test     whether dexmedetomidine really does have these advantages compared to propofol.      In this study, we hope to show that: dexmedetomidine is at least as good as propofol in     helping patients to sleep better and making them more comfortable, and that they are able to     communicate and cooperate better with the staff treating them, and that patients treated with     dexmedetomidine require a shorter time on the ventilator than those treated with propofol.   "
201131|NCT00479674|"     Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane®     (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and     tolerability. When combined with a taxane, platinum agents improve response in metastatic     breast cancer, with carboplatin conferring less toxicity than cisplatin. Monoclonal     antibodies including bevacizumab target vascular endothelial growth factor (VEGF) to reduce     angiogenesis. We hypothesize that the previously-untested combination of weekly Abraxane® and     carboplatin plus biweekly bevacizumab will lengthen time to progression without producing     intolerable toxicity.   "
201132|NCT00479687|"     This clinical trial is to determine the safety and effectiveness of three injections of     SUPARTZ (sodium hyaluronate) compared with saline (placebo) for the treatment of glenohumeral     osteoarthritis of the shoulder. The trial contains two phases. In the first phase subjects     are randomized to either SUPARTZ or placebo treatment. The second phase of the trial is     open-label so all subjects will receive SUPARTZ injections only.   "
201133|NCT00479700|"     To assess the safety and tolerability of ascending single oral doses of SAM-531 in healthy     subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of     SAM-531, an investigational drug, in healthy subjects and to evaluate the effect of a     high-fat meal on the PK of SAM-531 administered to healthy subjects.   "
201134|NCT00479713|"     This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin     versus rosuvastatin in participants with high cholesterol.   "
201135|NCT00479726|"     To assess the effectiveness of duloxetine administered once daily in patients with Major     Depressive Disorder in a practice based setting   "
201136|NCT00483626|"     The purpose of this study is to determine the clinical, functional and hemodynamic response     after six months of sildenafil 50 mg TID in patients with pulmonary arterial hypertension.   "
201137|NCT00483639|"     RATIONALE: Patients who undergo treatment for head and neck cancer may become anxious and     avoid contact with other people. Learning how cancer treatment may cause anxiety in patients     with head and neck cancer may help improve the quality of life in these patients.      PURPOSE: This clinical trial is studying anxiety and avoidance of others in patients     previously treated for head and neck cancer.   "
201138|NCT00483652|"     The purpose of the study is to show that individuals treated with Fampridine-SR tablets are     significantly more likely to have consistent improvements in their walking than those treated     with placebo tablets.   "
201142|NCT00483704|"     The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in     acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this     study are that telcagepant is superior to placebo, as measured by the proportion of     participants who have pain freedom, pain relief, pain freedom consistency, pain relief     consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.   "
201143|NCT00483717|"     The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute     treatment of migraine.   "
201144|NCT00483730|"     To assess clinical efficacy and safety of Actovegin in type 2 diabetic patients with     symptomatic diabetic peripheral polyneuropathy after 250 ml i.v. infusions once daily for 20     days followed by oral treatment 600 mg × 3 daily for 140 days.   "
201145|NCT00483743|"     This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated     nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x     6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood     cells and cytokines will also be studied.   "
201257|NCT00485199|"     To undertake a prospective randomized clinical study for treating retinal detachment due to     myopic macular holes, utilizing pneumatic retinopexy versus pars plana vitrectomy with gas     tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of     retinal detachment due to myopic macular hole.   "
201146|NCT00483756|"     A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune     system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this     research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant     patients for 12 months. Patients will be assigned to one of three treatment groups after     receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing     regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be     a standard-of-care control arm. Patients will continue to take the assigned study medication     for 12 months as well as other standard transplant medications such as prednisone.   "
201147|NCT00483769|"     Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by     glucose derangements   "
201148|NCT00483782|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving     carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and     paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer,     or primary peritoneal cavity cancer.      PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab     to see how well they work compared with carboplatin and paclitaxel alone in treating patients     with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal     cavity cancer.   "
201149|NCT00483795|"     To evaluate corneal staining after contact lens instillation with two different multi purpose     solutions.   "
201150|NCT00483808|"     To investigate the clinical utility of renal denervation in the treatment of refractory     hypertension.   "
201151|NCT00483821|"     RATIONALE: Gathering disease-related information from medical charts of patients with primary     head and neck cancer who have undergone neck dissection after complete response to     chemotherapy and radiation therapy may help doctors learn more about the disease and find     better methods of treatment.      PURPOSE: This clinical trial is evaluating the medical charts of patients with primary head     and neck cancer who have undergone neck dissection after complete response to chemotherapy     and radiation therapy.   "
201152|NCT00483834|"     Bevacizumab has recently been shown to improve survival when combined with chemotherapy in     patients with previously untreated metastatic colorectal cancer. Bevacizumab is usually given     together with infusional 5-FU, which requires a central line. A central line is inconvenient     for patients, and may increase risk of infection, and thrombosis. Furthermore, a central line     increases resource demands for interventional radiology, chemo daycare. Capecitabine is     administered orally, and converted to 5-FU intracellularly. Chronic administration of     capecitabine mimics infusional 5-FU. This study is designed to evaluate whether the     combination of irinotecan, capecitabine and bevacizumab is effective as a first-line therapy     for patients with metastatic colorectal cancer.   "
201153|NCT00483847|"     The primary objective of this study is to determine the incidence and pattern of serious     infections, malignancies, and other serious adverse events (SAEs) in participants with     multiple sclerosis (MS) treated with TYSABRI (natalizumab).   "
201154|NCT00483860|"     To determine the effect of renal impairment and prior platinum-based chemotherapy on the     safety and blood levels of topotecan administered orally   "
201155|NCT00483873|"     The purpose of the study is to collect EEG's as close to the cardiac arrest as possible using     a standard hospital EEG machine and an investigational EEG device to help determine the     neurological status of the cardiac arrest patient and to help decide on possible treatment     and chance of recovery. The investigational EEG machine will be simple to operate as well as     easy to interpret for the clinician and the nurses. It is not to replace the     electrophysiologist interpretation but to determine ealy on if further evaluation and     treatment can help the patient.   "
201156|NCT00483886|"     The purpose of this study is to determine whether prucalopride is safe and effective in the     treatment of chronic constipation.      Hypothesis:      Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the     treatment of patients with chronic constipation and is well tolerated in those patients.   "
201157|NCT00483899|"     This study was designed to look at safety aspects and effects of repeat inhaled doses of     GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic     obstructive pulmonary disease (COPD)   "
201170|NCT00484068|"     Diabetic nephropathy (DN) is a chronic diabetic complication and affects up to 40% of     patients. The first line treatment for DN is angiotensin blockers drugs that are used to     reduce the protein concentration in urine.Previous data showed that this protein, namely     albuminuria, could also be reduced in a short term-period by the replacement of red meat in     the diet with chicken. The aim of this study is to compare the effects of this chicken diet     with enalapril on albuminuria in a long-term period( 12 months)in type 2 diabetic patients.   "
201158|NCT00483912|"     The incidence of acute pancreatitis has been doubled during last three decades in Finland.     Alcohol is the main cause of acute pancreatitis in Finland accounting for 70 % of cases.     Although the mortality of acute pancreatitis has been decreased it still appears and     especially early multiple organ failure is the main cause of all deaths. Multiple organ     failure in the early course of the disease is thought to be caused by the release of     cytokines. Molecular adsorbent recirculating system (MARS) has shown to decrease mortality in     acute alcohol hepatitis and paracetamol intoxication. Also it has been shown to improve     kidney function due to hypoperfusion and tubulus necrosis and overrule decrease mortality in     patients with multiple organ failure due to different reasons. A part of patients with acute     alcoholic pancreatitis may have so-called fat liver already on admission. It has been shown     that the highest mortality is especially associated those with early liver and kidney     failure. MARS treatment has never earlier been used in the patients with acute alcoholic     pancreatitis and early organ failure. In this study we randomize patients with acute     alcoholic pancreatitis and early multiple organ failure (Sofa score>2) to two groups: 1)     Standard pancreatitis treatment in intensive care unit and 2) Standard pancreatitis treatment     in intensive care unit with 5 MARS sessions.   "
201159|NCT00483925|"     Langerhans-cell histiocytosis (LCH) is a rare disease with features of chronic inflammation     and hypopituitarism, conditions associated with increased risk of cardiovascular diseases.      Objective: To investigate glucose and lipid metabolism, insulin resistance, structural     arterial and functional endothelial properties in patients with multisystem LCH in a     prospective, observational study.      Interventions:Cardiovascular risk factors: arterial blood pressure, lipid profile,     mathematical indices of insulin resistance (IR), intima media thickness, brachial artery flow     mediated dilatation, dynamic indices of IR, pituitary function and C-reactive protein will be     estimated in patients with LCH and in a control group matched for gender, age, BMI and     smoking habits.   "
201160|NCT00483938|"     This study will compare the efficacy and safety of treatment with pegylated-interferon     alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study     treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than     or equal to (>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive     pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400     milligram [mg]) orally daily for the specified duration, followed by 24 weeks of     treatment-free follow-up. Participants with detectable HCV-RNA and less than (<) 2 log10 drop     in HCV-RNA at week 12 will discontinue therapy.   "
201161|NCT00483951|"     This study will evaluate volunteers 18 years of age and older to see if they qualify for one     of NHLBI s research studies. Tests include the following:        -  General medical evaluation, which may include blood tests, chest x-ray,          electrocardiogram (ECG) and echocardiogram (heart ultrasound).        -  Other tests as appropriate, such as magnetic resonance imaging (MRI), cardiac computed          tomography (CT scan of the heart), nuclear stress test and echocardiography stress test.        -  X-ray contrast studies of the heart and blood vessels. (These may be excluded in          patients with kidney risk factors.)   "
201162|NCT00483964|"     The purpose of this study is to determine whether a herbal combination of water based     extracts of Bacopa monnieri(BM) and Nardostachys jatamansi(NJ) is effective in the treatment     of Schizophrenia.      The working hypothesis for this study is that a herbal combination of BM and NJ will be as     effective as modern anti-psychotic drugs, in the treatment of Schizophrenia, and will be safe     for long term use.   "
201163|NCT00483977|"     The primary aim is to assess if PF-00592379 is able to reduce pain in patients with     osteoarthritis of the knee.   "
201164|NCT00483990|"     The main objective of the study is to determine the safety and tolerability of repeated     application of PSD502 to the glans penis in healthy male volunteers   "
201165|NCT00484003|"     The study will evaluate the safety and effect of pimecrolimus cream 1% on quality of life of     caregivers of South African children with mild to moderate atopic dermatitis (AD).   "
201166|NCT00484016|"     There are limited numbers of retrospective studies showing the effectiveness of adjuvant     chemotherapy over observation in resected lung cancers.   "
201167|NCT00484029|"     This purpose of this study is to evaluate the safety and efficacy of treatment with nasal CO2     in the treatment of pain and other symptoms related to temporomandibular disorder (TMD).   "
201168|NCT00484042|"     Background: Polyamines are essential compounds in all mammalian tissues. If tissue     spermidine/spermine levels, however, dramatically decrease, the cellular survival is severely     endangered. Transgenic animals, where the homeostasis of cellular polyamines can be disturbed     and tissue spermidine/spermine levels are decreased, acute pancreatitis evolves, indicating     pancreas to be one of the most vulnerable organs for tissue polyamine catabolism. On the     other hand, our own data suggests that also in other models of acute experimental     pancreatitis pancreatic polyamines are changed depending on the severity of pancreatitis in     such a way that the more severe pancreatitis the lower are the pancreatic polyamine levels.     Minor changes were observed also in rats undergoing sham operation only. In addition of     pancreatic enzymes, inflammatory mediators are also involved in the pathophysiology of the     disease. CRP, IL-6, IL-8, IL-10 and Procalcitonin are useful in predicting the severity of     the disease, combination of IL-6 and IL-10 at admission can predict organ failure with     sensitivity of 95 %, specificity of 88 %.      Hypothesis: Similar to experimental pancreatitis, blood polyamine changes are associated with     acute pancreatitis also in the man. These changes are dependent on the severity of     pancreatitis, but not on the etiology of pancreatitis. The changes are specific to acute     pancreatitis compared with other intra-abdominal emergencies. The changes observed return to     baseline during recovery. Furthermore, we assume that blood polyamine negatively correlates     with IL-6, IL-8, and procalcitonin, and positively with IL-10.   "
201169|NCT00484055|"     The aim of the present study is to evaluate a new technique for prevention of sternal wound     infection consisting of local application of collagen-gentamicin in addition to routine i.v.     antibiotic prophylaxis.      The technique has been evaluated in a previous randomised study. The aim of the present study     is to evaluate the technique after it has been introduced in clinical practise to monitor the     bacterial antibiotic susceptibility and to verify that the suggested reduction in sternal     wound infection still exits.   "
201171|NCT00484081|"     We evaluated the application of surgical testicular exploration with the aid of a microscope     (MictoTESE) to increase the chances of obtaining sperm in men with impaired sperm production,     a condition known as non-obstructive azoospermia.      We also evaluated the outcomes of these couples when the sperm obtained were used in ICSI     (Intracytoplasmic Sperm Injection) during assisted reproductive technology treatment.      We believe that excellent results may be obtained with the use of the following techniques in     the treatment of couples where non-obstructive azoospermia is a significant cause.   "
201172|NCT00484094|"     To provide safety and effectiveness information for Rapamune during the post-marketing period     as required by Korea Food and Drug Administration (KFDA) regulations in order to identify any     potential drug related treatment factors in the Korean population, such as:        1. Unknown adverse reactions, especially serious adverse reactions        2. To assess the incidence of adverse reactions under the routine drug uses        3. Factors that may affect the safety of the drug (e.g., proteinuria)        4. Factors that may affect the effectiveness of the drug   "
201173|NCT00484107|"     This post-marketing study will provide local safety and tolerance data on the use of     Premarin® vaginal cream.   "
201174|NCT00484120|"     This study valuates the safety and efficacy of treatment with 3% Diclofenac Nano-Emulsion     Cream versus Placebo in subjects with osteoarthritis of the knee.   "
201177|NCT00484159|"     Lumbar zygapophysial (facet) joint pain is a common cause of low back pain. Radiofrequency     (RF) denervation is an effective and low risk treatment of chronic low back pain of suspected     facet joint etiology. Blocks of the medial branches innervating the joints are commonly used     to localize the pain and make the diagnosis of facet joint pain.      There is currently no standard number of diagnostic blocks: zero, one, and two blocks have     all been utilized. Considering the high false positive and false negative rates of these     blocks, the cost: benefit ratio has been questioned. No study to date has examined the     practice of diagnostic medial branch blocks before RF denervation.      The purpose of this study is to determine the optimal number of blocks before radiofrequency     denervation. Three groups of patients will be studied. In group I, patients will undergo RF     denervation based on history and physical exam alone. In group II, patients will undergo RF     denervation based on a positive response to a single diagnostic block with local anesthetic.     In group III, patients will undergo RF treatment only after a positive screening block and a     positive confirmatory block.   "
201178|NCT00484172|"     The purpose of this study is to screen a pediatric population (ages 2-8) for genes associated     with childhood obesity.   "
201179|NCT00484185|"     To provide safety and effectiveness information of BeneFIX during the post-marketing period     as required by Korea FDA regulations, to identify any potential drug related treatment     factors in Korean population including:      1) Unknown adverse reactions, especially serious adverse reactions; 2) Changes in the     incidences of adverse reactions under the routine drug uses.      3) Factors that may affect the safety of the drug 4) Factors that may affect the     effectiveness of the drug   "
201180|NCT00484198|"     This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator     (Pioglitazone)-controlled, parallel-group study in subjects with type 2 diabetes currently     sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic     monotherapy. The total duration of a subject's participation will be approximately 30 weeks,     including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a     2-week post-treatment follow-up period.   "
201181|NCT00484211|"     The main objective of the trial is to document the progression free survival (PFS) in     advanced or metastatic hepatocellular carcinoma patients treated with NGR-hTNF as single     agent.      Safety will be established by clinical and laboratory assessment according to NCI-CTC     criteria   "
201182|NCT00484224|"     The purpose of this study is to determine wether vitiligo patients have more audiological     abmnormalities, than the healthy population.   "
201183|NCT00484237|"     This study will compare the safety and efficacy for two regimens of etanercept in patients     with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly     regimen and a 50mg once weekly regimen.   "
201184|NCT00484250|"     Oral lichen planus (OLP) is a chronic inflammatory disorder which causes local     irritation,discomfort and subsequent poor dentition and discomfort in eating . Various     treatments have been suggested for OLP but their results are unsatisfactory .Despite the fact     that steroids have been the main therapeutic choice for many years,some researches have been     done regarding the efficacy of other medication such as metronidazole and doxycycline.The     purpose of this study is to determine whether metronidazole and doxycycline are effective in     the treatment of oral lichen planus and to compare their efficacy with each other.   "
201185|NCT00484263|"     The purpose of this study is to determine whether the daily inhalation of nebulised     hypertonic saline (6%) will decrease the incidence of pulmonary exacerbations and increase     the quality of life for people with non cystic fibrosis bronchiectasis.   "
201186|NCT00484276|"     The main objective of the trial is to document the progression free survival (PFS) in     advanced or metastatic malignant pleural mesothelioma patients treated with NGR-hTNF as     single agent.      Safety will be established by clinical and laboratory assessment according to NCI-CTC     criteria.   "
201187|NCT00484289|"     The purpose of this study is to demonstrate the safety of chronic use of abatacept in     Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071,     IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX     intolerance.   "
201188|NCT00484302|"     The purpose of the trial is to investigate the effect of specialized treatment of cannabis     abuse among young people with psychosis. The specialized treatment consists of manualized     individual treatment and group therapy. It will be compared with the standard treatment,     which consists of non-specialized, non-manualized treatment. 140 patients will be randomised     to one of the two treatments, and the investigator(s) will be blinded to the treatment     received.   "
201189|NCT00484315|"     The purpose of the TAXUS PERSEUS Workhorse trial is to evaluate the safety and efficacy of     the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS®     ElementTM) for the treatment of de novo atherosclerotic lesions of up to 28 mm in length in     native coronary arteries of 2.75 mm to 4.0 mm diameter.   "
201190|NCT00484328|"     The purpose of this study is to determine if the medicines for chronic hepatitis C can be     taken once daily, instead of twice daily.   "
201191|NCT00484341|"     The main objective of the trial is to document the preliminary antitumor activity of two     doses of NGR-hTNF administered either alone or in combination with doxorubicin in locally     advanced or metastatic soft-tissue sarcoma (STS) patients untreated or previously treated     with one or more prior systemic regimen.   "
201192|NCT00484354|"     The purpose of this study is to determine if the incidence of acute renal failure (ARF) in     high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating     patients in the perioperative period with intravenous (IV) sodium bicarbonate. Patients will     be randomized in a 50:50 allocation to receive either IV sodium bicarbonate or IV normal     saline. The volume of fluid given in each arm of the study is equal. All other interventions     in those patients will be according to standard cardiothoracic anesthesia protocol at our     institution.   "
201258|NCT00485212|"     purpose: to determine wether a compression bandage prolongs analgesia of local infiltration     analgesia after total knee arthroplasty   "
201259|NCT00485225|"     Two stage study looking at different titration schedules in patients with moderate to severe     non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be     enrolled. Study participation is approximately 3 months.   "
201193|NCT00484367|"     The purpose of this study is to compare the effectiveness of two psychosocially-based,     manual-driven, behavioral modalities. One of these is a standardized version of the     established modality of Adolescent Group Therapy (AGT), which includes both psychoeducational     and therapeutic components. The other is a state-of-the-art family therapy approach,     Transitional Family Therapy (TFT), which integrates management of the current problem with     exploration of multigenerational issues. Both approaches have been developed to expressly     target adolescent alcohol problems.   "
201194|NCT00484380|"     Conventional coronary angiography is the recommended procedure in detection of coronary     stenosis in patients with heart valve disease referred for surgery.The aim of this     prospective study is to assess diagnostic accuracy of multislice spiral computed tomography     coronary angiography in patients with heart valve disease referred for surgery.   "
201195|NCT00484393|"     This is a small study known as a pilot study. This pilot study is being done to see if a     difference in pain from intramuscular palivizumab injection can be detected if tetracaine a     topical numbing gel is used compared to no medication (placebo). If a difference is found in     this pilot study, then a larger study may be done to confirm that there is a difference in     pain experience.   "
201196|NCT00484406|"     Some Matrix Metalloproteases, proteases degrading the extracellular matrix, play a relevant     role in structure and stability of atherosclerotic plaques. Atherosclerotic plaques     triggering acute coronary syndromes show increased expression of MMP-1, MMP-3 and MMP-9.     Regulation of these MMPs is plaid by genetic polymorphisms, G+/G- at –1563 for MMP-1, 4A/5A-     at –1612 for MMP-3, and a microsatellite (13-27 CA repeats around –90) for MMP-9.      It is conceivable that these polymorphisms correlate with the clinical outcome of acute     coronary syndromes, particularly with those without ST segment Elevation (NSTEACS).   "
201197|NCT00484419|"     A 16 week open-label study with subjects receiving background metformin monotherapy. 150     subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open     label rosiglitazone, or open-label sitagliptin.   "
201198|NCT00484432|"     The main objective of the trial is to document the response rate in patients affected by     metastatic ovarian cancer, treated with NGR-hTNF plus doxorubicin. Safety will be established     by clinical and laboratory assessment according to NCI-CTC criteria.   "
201199|NCT00484445|"     The purpose of this study is to identify acute and chronic medical conditions that are     identifiable early in the course of critical illness that are associated with transfer to     another health care facility (versus to home) upon hospital discharge.   "
201200|NCT00484458|"     The purpose of this study is to demonstrate that the Wallis System (interspinous process     implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate     degenerative disc disease (DDD) of the lumbar spine at the L4-L5 level.      This study will assess the safety and efficacy of the Wallis® System compared to commercially     available lumbar TDR with respect to individual subject success rates at 24 months     postoperative follow-up.      Study participants will receive all study related test articles and surgical procedures at no     charge. Please scroll down to the Locations section to find a doctor in your area that is     participating in this study. If you are interested in participating in this study and do not     see a doctor in your area, please contact Jose Naveira at jose.naveira@abbottspine.com   "
201201|NCT00484471|"     To compare combination treatment of aripiprazole plus valproate versus valproate alone in the     prevention of relapse in bipolar I disorder patients with symptomatic remission after 5-6     weeks open-label acute treatment with aripiprazole plus valproate for manic or mixed episode,     with or without psychotic features.   "
201202|NCT00484484|"     Long-term opioid therapy is commonly administered for the management of severe cancer pain.     Increasing doses of opioids are titrated against effects until analgesia is achieved or     intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor     antagonist, has been reported to improve analgesia in patients with uncontrolled pain     receiving high doses of opioids. This study aims at determining the effectiveness of ketamine     as an adjuvant to opioids in relieving cancer pain.   "
201203|NCT00484497|"     The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.   "
201204|NCT00484510|"     This study will look at the impact of ascorbic acid (Vitamin C) on the progression of disease     in people with CMT1A as compared to volunteers receiving a placebo. This study will assess     whether is it futile to proceed with a larger, longer-term, placebo-controlled study.   "
201229|NCT00484835|"     The Hypothesis of this study is that performing total abdominal hysterectomy using the newer     electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to     the traditional clamp & suture technique will result in reduction of operating time,     intra-operative blood loss, post-operative pain.   "
201254|NCT00485160|"     The purpose of this study is to determine whether closure of the PDA in premature neonates     using IV ibuprofen vs continuous IV indomethacin has different side effects, eg. effects on     renal function, on blood flow velocity in the superior mesenteric artery, the anterior     cerebral artery, and the renal artery.   "
201205|NCT00484523|"     MRI is a powerful imaging tool used for the precise study of brain morphology (morphometric     study, tissue study, study of connectivity).      Isotopic examinations by Single Photon Emission Tomography (SPET) and Positron Emission     Tomography (PET) are used to explore cerebral perfusion metabolism (99mTc- ECD SPET and 18FDG     PET), as well as dopaminergic neurotransmission (123I FP-CIT SPET, DATSCAN®).      These examinations routinely contribute to the clinical diagnosis and surveillance of many     neurological pathologies (dementias, Parkinson syndromes, epilepsies, concussions, vascular     pathology, brain tumors, etc.).      As a result of the original morphological and functional information they provide, these     examinations are being increasingly included in clinical research protocols involving the     brain.      The absolute or relative quantification of anomalies observed, however, can be obtained only     after comparison to a database of normal subjects.      The creation of these databases is currently limited by their cost and strictly single center     nature (physical characteristics of each center's MRI, gamma cameras and PET scanner).      The aim of this multidisciplinary study is to constitute a standardized database of multimode     neural imaging (SPET, PET and MRI) to be able to objectively quantify anomalies observed in     patients, at the scale of a group or an individual, for the diagnosis and surveillance of     neurological diseases.      Participants will be paid €350. 60 healthy subjects between 20 and 80 years of age (30 men     and 30 women) will be recruited over 3 years. 4 examinations will be programmed over 2 days     (one cerebral MRI, on 18FDG PET, one 99mTc-ECD SPET and one DATSCAN®).      The strictly single center character of this study is explained by the variability of the     physical characteristics of the imaging equipment used (MRI, SPET and PET scan) inherent to     each center.   "
201206|NCT00484536|"     The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in     patients with relapsing forms of multiple sclerosis   "
201207|NCT00484549|"     Fabry disease is a genetic disease due to an enzymatic deficit. A screening of this disease     allows patients to benefit from an enzyme replacement therapy and prevent the occurrence of     life threatening manifestations such as an ischemic stroke.      The purpose of the study is to determinate the prevalence of Fabry disease in a population of     male patients hospitalized for an ischemic stroke.      This study, with a screening of Fabry disease, allows the patients to make a precise     diagnosis of their ischemic stroke and to facilitate the screening of the other members at     the facility.   "
201208|NCT00484562|"     Objectives:      The objective of this study is to determine if any differences exist between the varying     modes of portable oxygen delivery systems including liquid oxygen, a portable concentrator,     portable devices filled at home from a concentrator, and medical grade compressed oxygen     (either an M6 size or D size cylinder).      Hypothesis:      Patients who are prescribed LTOT will show similar physiologic responses to exercise when     using differing modalities of portable oxygen delivery systems.   "
201209|NCT00484575|"     Inhaled sevoflurane during coronary artery bypass grafting (CABG) reduces postoperative     Troponin levels and may be associated with improved outcome. A dose-response effect has been     demonstrated by de Hert et al, with greatest reductions of Troponin when Sevoflurane was used     during the entire operation, as compared to Sevoflurane during parts of the operation.      Sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. Postoperative     sedation after CABG is currently achieved with intravenous propofol.      A new simplified method of administration of isoflurane or sevoflurane has been developed and     tested by members of the research group. The Anesthetic Conserving Device is a modified     heat-moisture exchanger (HME) that permits direct infusion of sevoflurane to the airway,     where it is vaporized in an evaporator rod in the device.      The primary aim (and primary hypothesis)of the current trial is to examine if postoperative     sedation with sevoflurane after CABG is associated with improved cardiac outcome, measured as     reduced levels of Troponin, BNP and reduced incidence of cardiac events, such as atrial     fibrillation, need for inotropic drugs and myocardial infarction, compared with conventional     propofol sedation.      Other end-points of the trial are potential renal (protective) effects measured with cystatin     C levels, need for dialysis but also measurements of inorganic fluorides in serum, as well as     environmental aspects of sevoflurane sedation in a Cardiothoracic Intensive Care Unit.     Furthermore, potential differences in ICU memories and well-being during stay in the     intensive Care Unit will be investigated via patient questionnaires.      Besides routine blood sampling, plasma will be saved for later analysis of inflammatory     mediators (biobank).   "
201210|NCT00484588|"     Detect the clinical causitive pathogen of Ventilator Associated Pneumonia (VAP) patients by     the bronchoalveolar lavage (BAL) method.   "
201211|NCT00484601|"     This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin.     It also aims to explore the relationship between EBV DNA and clinical response in patients     with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy.   "
201212|NCT00484614|"     Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled     into the study and will undergo both high-resolution positron emission mammographic (PEM)     imaging and contrast-enhanced magnetic resonance imaging (MRI) of the breast(s). The purpose     of this study is to determine changes in surgical management resulting from PEM or MRI     imaging as compared to conventional imaging and to determine if the changes were appropriate     with histopathology as gold standard.   "
201213|NCT00484627|"     This study was designed determine whether use of creatine monohydrate, a dietary supplement,     can increase skeletal muscle mass and strength and improve the response to progressive     resistance exercise training in people with HIV infection.   "
201214|NCT00484640|"     The study goal is to conduct a randomized controlled trial to compare safety and accuracy of     dosing based on clinical information including the clinical reason for your taking coumadin,     your age, gender, your body surface area, and other medical conditions you may have with     dosing estimated by a dosing calculator which adjusts for factors affecting coumadin dosing     variability including genotypes for genes important in Coumadin metabolism and response. The     hypothesis to be tested by this trial states that:when compared to patients managed with a     best practices standard-of-care coumadin dosing regimen, patients randomized to coumadin     dosing based on genetically programmed metabolic capacity and other known clinical and     environmental factors affecting dose will: 1)show reduced risk of adverse events (using     surrogate measures of such events); and 2)more rapidly achieve Coumadin dosing.   "
201252|NCT00485134|"     The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal     vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea,     dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.   "
201255|NCT00485173|"     The purpose of this study is to evaluate the safety and effectiveness of the investigational     implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of     facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical     degenerative disc disease.   "
201215|NCT00484653|"     This is a prospective multicentric study including six clinical units of Gynecology and     Obstetrics (5 public health hospital and one private team), one research team in clinical     microbiology and one Center of Clinical investigation (CIC).      There is a correlation between premature delivery and bacterial vaginosis. So, the anomalies     of vaginal flora are a potential target for the campaign against prematurity.      The main objective of this study is to achieve an objective and reproducible technique of     identification and quantification by molecular biology of lactobacilla and all the other     micro-organisms involved in vaginal flora anomalies.      The secondary objectives are the exhaustive culture of bacteria, the characterisation of     intermediate vaginal flora and bacterial vaginosis among pregnant woman by PCR targeting the     ribosomic ADN 16S coupled with clonage techniques.      The number of patient to include is 1000 (time of inclusions: 24 months). The vaginal smears     will be realized until 32 weeks of gestation (Max: 3 taking of vaginal smears by patient).   "
201288|NCT00485615|"     The primary objective is to evaluate the efficacy of an enteric-coated, eicosapentaenoic     acid-concentrated fish oil in the treatment of social phobia. A secondary objective is to     determine if treatment outcome is related to plasma phospholipid essential fatty acid status,     niacin skin flush and measures of lipid/protein peroxidation.   "
201216|NCT00484666|"     Primary objective:      To estimate the overall clinical response rate (CR, PR, SD) of weekly docetaxel and weekly     topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer.      Secondary objectives:      To access the safety and tolerability of this novel combination chemotherapy regimen of     weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or     primary peritoneal cancer      To estimate the progression free survival (PFS) and overall survival (OS) for women with     recurrent platinum resistant ovarian or primary peritoneal cancer treated with this weekly     docetaxel and weekly topotecan.   "
201217|NCT00484679|"     The purpose of the study is to see whether treating alopecia areata with injections of the     corticosteroid, Triamcinolone acetonide 10mg/cc (Kenalog-10), has an impact on the adrenal     glands.   "
201218|NCT00484692|"     Background      Smokers often reject drugs as smoking cessation aids. Nonpharmacological interventions are     notoriously under-evaluated.      Methods      We conducted a randomized clinical trial in which we compared a medication, i.e.,     sustained-release bupropion (Zyban®; 413 subjects), at the time of the trial the most     efficacious pharmacological smoking cessation aid, with an ultrashort psychotherapeutic     intervention, Psychodynamic Model Training® (366 subjects), a manual-based psychodynamically     oriented 1 ½ day autosuggestion training. Outcome criterion was 12-month self-reported     continuous abstinence confirmed by urine cotinine levels below the level of detection (13     ng/ml) or, in an independent analysis, by exhaled carbon monoxide of 10 ppm or less at all     interviews conducted at 3, 6, and 12 months.   "
201219|NCT00484705|"     Hypothesis:      The overall hypothesis is that women with PCOS, both obese and non-obese, have larger     adipocytes, altered metabolism and signs of inflammation in adipose tissue and that these     changes are associated with high sympathetic nerve activity, hyperandrogenism     hyperinsulinaemia, insulin resistance with progression to type II diabetes and cardiovascular     disease (CVD) as well as psychological distress and reduced quality of life. Physical     exercise and electro-acupuncture decrease high concentrations of androgens, induce regulare     menstrual pattern, inhibits high sympathetic activity and restore the PCOS induced     disturbances.   "
201220|NCT00484718|"     The Purpose of this trial is to evaluate the use of a cross-over trial design in an     osteoarthritis population. We will determine the inter- and intra-subject variability in     osteoarthritis (OA) endpoints and evaluate if efficacy can be detected by measuring OA     endpoints following treatment with 2 different types of analgesics in a crossover study of     this design.   "
201221|NCT00484731|"     The effect of intraoperative infiltration of the operation site with bupivacain on the     development of chronic pain is the object of our trial. We hypothesize that the occurrence of     chronic pain in the goup of patients receiving the infiltration will be 50% less than in the     placebo group receiving normal saline. The study is a randomized controlled triple blinded     trial with a sequential study design.   "
201222|NCT00484744|"     The purpose of this research study is to compare pain control effectiveness of two medicines     and a placebo (a dummy pill that does not contain any pain relieving medication) to see which     one works better at preventing pain when taken both 1 hour before and 6 hours after     orthodontic separators are placed. The research hypothesis is that there will be a     significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that     this effect will differ for acetaminophen versus ibuprofen.   "
201223|NCT00484757|"     15 patients with narcolepsy and 15 healthy controls will be included in the study. According     to a randomized, double-blind protocol they will receive intranasally at night first Orexine     A and approximately two weeks later placebo or vice versa. Thereafter sleep will be recorded,     the cytokine-system and neurocognition characterized.   "
201224|NCT00484770|"     The primary hypothesis is that, in patients with advanced heart failure, an outpatient fluid     management strategy guided by BNP levels and clinical targets will lead to fewer days     hospitalized or dead over a 3-month period compared to an outpatient fluid management     strategy using clinical targets alone.   "
201225|NCT00484783|"     NOTES access is safe and feasible in the controlled human setting and comparable to     standard-of-care surgical techniques. NOTES exploration of the abdomen provides adequate     visualization comparable to laparoscopy.   "
201226|NCT00484796|"     Hypothesis: Trigeminus-evoked somatosensory potentials (TRI-SEP) may be used as an     alternative technique to medianus-evoked somatosensory potentials (MED-SEP) in patients     undergoing elective carotid surgery.   "
201227|NCT00484809|"     This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept)     in an Indian population. It will provide surveillance on a currently approved indication for     Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients     with moderately to severely active rheumatoid arthritis.   "
201228|NCT00484822|"     Often it is necessary to temporarily discontinue OAT when surgical or other invasive     procedures are required. However, there is no consensus on the optimal management in these     situations, and heparin bridging therapy is the current usual practice in these situations.     No large randomized, controlled clinical trials have been yet performed to evaluate the     efficacy and safety of a low molecular weight heparins (LMWH) as bridging therapy.   "
201457|NCT00487708|"     This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and     pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients     with NALP3 mutations whose clinical symptoms are either untreated or insufficiently treated     and require medical intervention.   "
201256|NCT00485186|"     The extend of steroid biosynthesis and action is mainly dependent on underlying genetic     polymorphisms and gene mutations. These sequence variations in multiple genes involved in     steroid biosynthesis and action cause different diseases (for example congenital adrenal     hyperplasia or disorders of sex development). In addition, sequence variations in several     other genes may influence the severity of a genetically caused disease of steroid     biosynthesis or action. By this, the differences in an observed phenotype may be explained.     Within the study all genes necessary for adrenal and gonadal steroid biosynthesis and several     genes which are known to influence the action of steroid hormones will be analysed in     patients with congenital disorders of adrenal and gonadal steroid biosynthesis, disorders of     steroid action and disorders of sex development. The primary aim is to set up a correlation     of the disease phenotype with the different genotypes detected.   "
201230|NCT00484848|"     Totally implanted venous access ports allow a safe delivery of medication, mainly     chemotherapy, but are also used for blood sampling. This last procedure is not always     successful, as it appeared from a nurse's survey in different hospitals in Flanders,     including the University Hospitals in Leuven, Belgium. In 3 to 29 percent of the attempts,     blood withdrawal is impaired or not possible, as an intermittent or permanent fact. This is     in line with international literature data where difficulty in blood draw was noted in 6 to     26% of port accessions. Partial or total occlusion leads to discomfort for the patient, delay     in therapy, higher costs and extra nursing time.      A new port system with a tangential outlet (Vortex port) was designed and according to the     manufacturer, this shape will allow to cleanse the entire reservoir of the port more     efficiently and avoid the formation of precipitates of medication or blood that could lead to     an obstruction of the device. These precipitates are also regarded as a potential risk factor     for infection.      However, only one previously published small randomised study addressed the value of the     Vortex port when compared to conventional access devices: Stevens et al. were able to show a     reduction in obstruction incidence from 26% to 7% with the use of the Vortex port. The     incidence of blood withdrawal problems in our experience with conventional ports in     University hospitals Leuven was 8% thus lower than that reported by Stevens, but this remains     the most frequent problem faced by care providers and patients.      With this study, the investigators aim to compare the performance of the tangential outlet     ports and that of a conventional port in order to assess an eventual functional difference.   "
201231|NCT00484861|"     African Americans have a higher prevalence of vascular disease than Caucasians. Vascular     disease can lead to heart attacks, strokes and even amputations. Insulin, a hormone which is     secreted by the pancreas, affects not only glucose and fat metabolism but also vascular     disease. Impairment of insulin s ability to remove glucose from the circulation is known as     insulin resistance. To overcome insulin resistance the pancreas secretes extra insulin. These     high levels of insulin affect circulating triglyceride levels by both promoting production of     triglyceride by the liver and interfering with clearance of triglyceride from the     circulation. Triglyceride in turn contributes to the development of vascular disease by     causing both inflammation and hypercoagulability.      Surprisingly African Americans are more insulin resistant and have a higher rate of vascular     disease than Caucasians but have lower triglyceride levels. Because of the high rate of     vascular diseases in African Americans, our aim is to determine if the adverse effects of     triglyceride occur at a lower level in African Americans than Caucasians. To achieve this     goal we will determine if there are differences in the effect of a meal on triglyceride     levels and vascular function in a representative cohort of African American and Caucasian     women.      For this study we will enroll 96 women (48 African American and 48 Caucasian women). We are     recruiting women because ethnic differences in triglyceride are even greater in women than     men. We are enrolling women between the ages of 18 and 65 years. The study will involve     several outpatient visits to the NIH Clinical Center. The first visit will be a screening to     determine eligibility. At the second visit a test to measure insulin resistance will be     performed. This test is called a frequently sampled intravenous glucose tolerance test. The     third visit will be for the test meal. Before and at 2, 4 and 6 hours after the meal, blood     will be drawn and vascular function measured. Vascular function is determined by taking blood     pressure and then measuring blood flow in the arm with ultrasound. It is possible that     individual differences in diet could affect the results of the vascular study on the day of     the test meal. Therefore for 7 days prior to the test meal, the NIH Clinical Center will     provide to each participant all their meals in the form of either trays or meals in a box.     These meals will be consistent with the typical American diet and be 33% fat, 15% protein and     52% carbohydrate. In designing these meals, the dietician will take into account individual     food preferences.      This study is being performed in collaboration with the Harvard School of Public Health, the     University of Texas Southwestern Medical Center and Indiana University. Therefore some blood     drawn during Visits 2 and 3 will be sent coded, without personal identifiers, to each     institution for analyses.   "
201232|NCT00484874|"     The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab     (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what     side effects these patients get when they take Bexxar® and if Bexxar® is effective in     treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of     radiation to cancer cells.   "
201233|NCT00484887|"     This study will collect a large amount of hernia mesh explants and study the changes that     occur in the materials in vivo to use the information to help design new mesh made from novel     materials. We will have evidence that our current options are not only inadequate but can     lead to complications. One of our main goals is to convince our colleagues to change their     surgical practice by publishing and educating them with this data.   "
201234|NCT00484900|"     The purpose of this open randomised multi-centre clinical trial is to test the hypothesis     that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine,     administered over 24 hours is not inferior in efficacy to the same drug administered over 48     hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine     As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy     to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60     hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum     malaria.   "
201235|NCT00484913|"     We investigated, whether abdominal hot compresses effect hepatic blood flow. Our hypothesis     was, that the hot compresses might either by local vasomotor-reflex or by decreasing the tone     of the sympathetic nerve system increase hepatic blood flow.   "
201236|NCT00484926|"     The purpose of REAL-LATE (Correlation of Clopidogrel Therapy Discontinuation in REAL-world     Patients Treated with Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic     Events) trial is to assess the relationship between clopidogrel use and long-term rates of     cardiac death or MI after DES implantation in real-world practice and to estimate the     duration of dual antiplatelet therapy for preventing the late thrombotic events.   "
201237|NCT00484939|"     This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination     with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with     metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5     mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000     mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m^2     orally twice a day on Days 1-14 of each 3-week cycle) alone.      No notable trends or interactions in laboratory values, electrocardiogram, or vital signs     suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or     capecitabine monotherapy were observed during the study.   "
201253|NCT00485147|"     The maximal walking distance (MWD) performed on treadmill (TT) remains the gold standard in     estimating the walking capacity of patients suffering from peripheral arterial disease (PAD)     with intermittent claudication, although treadmills are not accessible to most physicians. We     hypothesized that global positioning system (GPS) recordings could monitor community-based     outdoor walking and provide valid information on walking capacity in PAD patients.   "
201496|NCT00488228|"     The purpose of this pilot study is to determine whether incorporating self-regulation     training using daily weighing is efficacious within a behavioral weight loss program     specifically targeting young adults.   "
201238|NCT00484952|"     Objectives        1. To determine the burden and characteristics of rotavirus-associated hospitalizations          among children under five years of age of northern Israel        2. To identify potential risk factors of rotavirus infections associated with          hospitalizations among Jewish and Arab children younger than five years of age.      Methods:      Study design: A two-year prospective study and a nested case control study will be carried     out Collection of data: Questionnaires will be filled in with demographic characteristics of     patients and data on the clinical manifestation of the diarrheal episode leading to     hospitalization. Stool specimens will be systematically collected from all children     hospitalized because of diarrheal diseases and examined for rotavirus and for bacterial and     protozoan enteropathogens. Positive samples for rotavirus will be tested for G and P     genotypes.      For the nested case control study additional data will be obtained from parents' interviews     on variables such as: parents' education, parents' age, parents' occupation, no. of siblings,     age of siblings, breastfeeding etc. to identify potential risk factors for rotavirus diarrhea     necessitating hospitalization.      Data analysis: Methods of descriptive statistics / epidemiology will be applied to determine     the characteristics of the burden of rotavirus-associated hospitalizations (the distribution     of diarrhea associated hospitalizations by etiology, rates of rotavirus diarrheal diseases in     Jewish and Arab children, age specific rates of rotavirus infections, the percentage of     hospitalizations due to rotavirus diarrhea by month, etc.      For the nested case control study, univariate analysis will be first performed using Student     t test for continuous variables and chi square test for categorical variables to study the     statistical significance of predictive factors of rotavirus diarrheal diseases necessitating     hospitalization. Multivariate analysis using logistic regression models will be performed to     study the independent effect of each variable. Odds ratios (OR) and 95% CI will be computed     for each variable. Two tailed p < 0.05 will be considered significant.   "
201239|NCT00484965|"     The purpose of this study is to determine whether erythrocyte mediated dexamethasone delivery     reduces circulating inflammatory markers after coronary stent implantation and improves     clinical and angiographic outcomes.   "
201240|NCT00484978|"     Brain metastases (BM) are the most common intracranial tumors in adults and source of the     most common neurological complications of systemic cancer. Surgery and radiation therapy are     the most important components in the management of BM with the goal to prolong survival and     improve the quality of life. Whole brain radiotherapy (WBRT) has shown to increase local and     distant control both with and without surgical resection. However, patients who develop a new     or recurrent BM after WBRT and undergo resection are left without adjuvant therapy options.     Local recurrence particular in patients with single metastasis does effect both survival and     quality of life. In individual cases the option of additional radiotherapy has been suggested     and applied. We seek to evaluate the addition of a stereotactic radiosurgery (SRS) boost to     the resection cavity both as adjuvant and salvage procedure among patients, who undergo     resection of a BM and previously received WBRT or decline WBRT. Goal is to show superior     local brain control.   "
201241|NCT00484991|"     The Purpose of this study is to provide patients with hyperphenylalaninemia (HPA) due to     Phenylketonuria (PKU) access to sapropterin dihydrochloride and to collect more information     about the safety of the drug in an expanded access program (EAP) until commercial product is     available.   "
201242|NCT00485004|"     To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent     implantation with sirolimus-eluting implantation versus cutting balloon angioplasty   "
201243|NCT00485017|"     The purpose of this study is to evaluate the safety and effect of THR-4109 on weight loss in     obese subjects over a 24-week treatment period.   "
201244|NCT00485030|"     To evaluate the best therapeutic option for the treatment of diffuse type post-drug-eluting     stent restenosis.   "
201245|NCT00485043|"     The purpose of this study was to evaluate the effects of TC for Arthritis on physical     function, pain, and stiffness in older adults with knee/hip OA. Two hypotheses were tested:        1. Individuals in the TC group will demonstrate greater improvements in physical function          compared to control group participants.        2. Individuals in the TC group will demonstrate greater decreases in pain and stiffness          compared to control group participants.   "
201246|NCT00485056|"     This study aims to use a novel, sensitive, non-invasive scanning technique to investigate the     effects of insulin-sensitizing agent pioglitazone, on heart and artery function.   "
201247|NCT00485069|"     Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease     (PD) on 20 October 2006.      ROP is expected to be used for a long term in clinical practice. However, no long-term     clinical data with ROP administered three times daily are currently available from Japanese     patients, and the clinical experience with ROP at >10mg/day is limited.      For this reason, this study was designed as a multicenter open-label uncontrolled study.      This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating     Scale (UPDRS), Awake time spent Off/On, Modified Hoehn & Yahr stage, Schwab-England     scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI))     and the long-term safety of ROP administered three times daily for in PD patients.   "
201248|NCT00485082|"     This study will examine the experience of disclosing a cystic fibrosis (CF) diagnosis to a     dating partner. CF has implications for potential life partners (issues of fertility,     decreased life span and an increasing need for medical management with age) that may make     disclosure particularly sensitive. An understanding of the disclosure process may provide     insight into ways health care practitioners can support their patients during this process.      People between 21 and 35 years of age with CF who have been in at least one dating     relationship may be eligible for this study.      Participants are interviewed by telephone about their experiences living with cystic fibrosis     and telling dating partners about their diagnosis. The interview includes questions about:        -  Past experiences disclosing their CF diagnosis to a dating partner        -  What information was disclosed versus what was not disclosed        -  Why certain information was disclosed or not disclosed        -  Positive and negative implications of the disclosure or non-disclosure      The interview lasts about 60 minutes and is tape-recorded for later review and analysis.   "
201249|NCT00485095|"     The purpose of this study is to determine whether supplement of plant sterol could lower     blood cholesterol.   "
201250|NCT00485108|"     The type of anti-inflammatory medication used post selective laser trabeculoplasty (SLT) may     have an impact on the intra-ocular pressure (IOP) lowering effect of SLT. This study will     evaluate the IOP lowering effect of SLT following the topical administration of one of the     following: prednisolone 1%, ketorolac 0.5% or artificial tears.   "
201251|NCT00485121|"     The purpose of this study is to investigate the effects of adding ezetimibe to statin therapy     on levels of inflammatory markers and adipokines in patients with atherosclerosis disease and     features of the metabolic syndrome,whose LDL-c remains above target (> 2.0 mmol/L) despite     statin monotherapy.      We hypothesize that the addition of Ezetimibe (10mg per day for 12 weeks) to ongoing statin     therapy in patients with atherosclerosis and features of the metabolic syndrome will     favourably modify levels of inflammatory biomarkers and adipokines.   "
201260|NCT00485238|"     The aim is to determine which approach, immediate argon laser peripheral iridoplasty or     conventional systemic medical treatment efficiently breaks acute angle closure attack without     consequent visual morbidities. The specific objectives are to see whether sudden intraocular     pressure(IOP) lowering brought about by laser iridoplasty or medical treatment affects optic     nerve head structure and function and identify if immediate decompression is associated with     greater incidence of ocular problems like corneal endothelial compromise, optic disc edema,     macular edema, decompression retinopathy, cataract formation, progression to chronic angle     closure.   "
201261|NCT00485251|"     The operation used for treating cancer in this location of the colon is called right     hemicolectomy. Currently the investigators have two methods of minimal access approach to the     abdominal cavity in order to complete this operation:        1. Total Laparoscopic right hemicolectomy The operation is completed by laparoscopic          instruments using video laparoscopy. At the end of the procedure, a small wound was          created for the delivery of bowel and extracorporeal anastomosis.        2. Hand-assisted laparoscopic right Hemicolectomy A 6.5cm incision is used to allow          insertion of one of the surgeon's hands into the abdomen. The operation is completed by          the surgeon's hand and laparoscopic instruments, using video laparoscopy.      These two operations are essentially identical except for the surgical access. Both total     laparoscopic and Hand-assisted laparoscopic surgery has been practiced in the United States     and Europe for over 10 years. Studies from the United State and Europe have demonstrated the     safety and the benefits of both techniques in terms of pain and recovery. In order to find     out which one is a better procedure, the investigators are carrying out a clinical trial to     compare the two surgical options in their short-term and long term outcomes.      The results of this study may have an impact on the care of similar patients in the future.   "
201262|NCT00485264|"     Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral     replication. Raltegravir is a drug that prevents integrase from working properly. This drug     has been tested for safety and efficacy in adults, but this is the first study to examine     raltegravir in children and adolescents. The purpose of this study was to determine the     appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of     age, by acquiring short and long term safety data, intensive and population pharmacokinetic     (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.   "
201263|NCT00485277|"     The current trial, BNIT-BR-002, will evaluate the safety and biological activity of a fixed     dose of MVA-BN®-HER2, with and without Herceptin, following 1st- or 2nd-line chemotherapy in     patients with Her-2-positive metastatic breast cancer.      The intent of vaccination is to induce anti-Her-2 immune responses, both antibody and T cell,     that will then attack the Her-2 expressing tumors, and may induce tumor regression or slow     progression of disease.   "
201264|NCT00485290|"     The reason why esophagus varices suddenly rupture and start to bleed is unclear. Food intake     increase the hepatic blood flow and the portal pressure, but it is yet unknown if there is     also an increase in variceal pressure. The aim of this study is to evaluate the efficacy of a     meal on variceal pressure with a non invasive endoscopic measurement device, and compare it     with portal pressure.   "
201265|NCT00485303|"     The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in     participants with advanced prostate cancer (a disease in which cells in the prostate gland     become abnormal and start to grow uncontrollably, forming tumors).   "
201266|NCT00485316|"     The aim of the investigators' randomized trial is to compare the short-term clinical outcome     and survival between laparoscopic-assisted and open resection of colorectal carcinoma.   "
201267|NCT00485329|"     The study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability     and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous     ulcers patients.   "
201268|NCT00485342|"     The aim of this study is to compare two therapeutical strategies concerning the combination     therapy (peginterferon alfa-2a and ribavirin) in naïve patients with chronic hepatitis C of     genotype 1. Reference strategy corresponding to standards of care recommended by the French     consensus conference versus Test strategy corresponding to adaptation strategy of ribavirin     dose during the first week according to AUC (area under the curve) of ribavirin plasmatic     concentration after the first intake (Day 0) of 600 mg   "
201269|NCT00485355|"     The purpose of this study is to compare two ways of performing laparoscopic hysterectomy -     robotic-assisted vs. conventional laparoscopy.   "
201333|NCT00465374|"     30% of ARDS patients ventilated according to NIH protocol presents CT scan evidence of     hyperinflation. Functional analysis of pressure-time curve (Stress Index=SI) has been shown     to identify this condition in experimental settings. We tested the hypothesis that the SI is     an accurate predictor of mechanical stress due to overdistention in ARDS patients.   "
201270|NCT00485368|"     The purpose of this research is to assess the effects of a drug called perindopril on the     aorta in people known to have Marfan Syndrome. The aorta is the major artery of the body that     comes out of the heart and supplies blood to the body. We know that in people with Marfan     Syndrome, the aorta is stiff and this stiffness results in its enlargement over many years.     This enlargement of the aorta can be very serious. We know from treatment of other heart     conditions that drugs of the same type as perindopril reduce stiffness of the arteries. This     type of drug has never been tried in people with Marfan Syndrome.   "
201271|NCT00485394|"     The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic     solution and drug-free solution to safely and effectively treat geographic atrophy associated     with age-related macular degeneration.   "
201272|NCT00485407|"     The purpose of this trial is to test the value of dose increases in patients with residual     ADHD symptoms after treatment with the usual target dose of atomoxetine   "
201273|NCT00485420|"     The study aim is to explore the effect of a comprehensive Internet-based disease management     program for bipolar disorder and recurrent or chronic major depression on clinical outcomes     and satisfaction with care.   "
201274|NCT00485433|"     The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of     bupivacaine HCl.   "
201289|NCT00485628|"     Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients with ADHD.   "
201275|NCT00485446|"     This study was designed to evaluate the incidence of both, inherited and adquired     thrombophilia, and thyroid autoinmunity in unknown infertility (UI), implantation failure     (IF) and recurrent miscarriage (RM). To focus on these particular disorders and to rule out     another potential confounding variables, 4 particular groups of women were created. Only     young women (< 38 years old), patients whose previous preimplantation genetic screening (PGS)     cycles displayed an acceptable rate of aneploidies, and women without organic uterine     abnormality, autoimmune disease or endocrine disorder were included in the study.   "
201276|NCT00485459|"     The purpose of this protocol is to investigate the acute treatment efficacy, safety, and     tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and     adolescents with ADHD.   "
201277|NCT00485472|"     The purpose of this trial is to evaluate the effectiveness, safety and tolerability of     lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.   "
201278|NCT00485485|"     Primary Objective:        -  To determine the efficacy of the combination of imatinib mesylate and docetaxel in          recurrent or metastatic head and neck squamous cell cancer by serial measurements of          tumor response (extent, frequency, duration).      Secondary Objectives:        -  To assess the safety and tolerability of imatinib mesylate and docetaxel in patients          with recurrent or metastatic head and neck squamous cell cancer.        -  To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by          immunohistochemical analysis of microvessel density and phosphorylation of          Platelet-derived growth factor receptors (PDGF-R).        -  To explore the effects of imatinib mesylate and docetaxel on surrogate markers in serum.        -  To assess the rate of survival.   "
201279|NCT00485498|"     The purpose of this study is to examine whether olanzapine, compared to risperidone, can     provide more adequate and timely control of behavioral agitation in acutely ill subjects with     schizophrenia.   "
201280|NCT00485511|"     Spinal muscular atrophy (SMA) is an autosomal recessive disorder in humans which results in     the loss of motor neurons. It is caused by reduced levels of the survival motor neuron (SMN)     protein as a result of loss or mutation of the SMN1 gene. SMN protein is encoded by two     genes, SMN1 and SMN2, which essentially differ by an single nucleotide in exon 7. As a     result, the majority of the transcript from SMN2 lacks exon 7. According to clinical     severity, SMA was classified to three types, including type I, type II, and type III.      Drugs capable of modifying the transcription pattern of SMN2 to increase the full-length of     SMN mRNA expression and the amount of SMN protein may have therapeutic effects for SMA     patients. In order to test this hypothesis, we used EBV-transformed lymphoblastoid cell lines     derived from the different types of SMA patients to screen the effect of various drugs on     SMN2 gene expression. Hydroxyurea (HU) was found to be effective among the drugs we tested.     HU is an effective therapeutic agent for patients with thalassemia and sickle cell disease     which the toxicity is minimal and is well-tolerated and safely used in children. We had     undergone a small-scaled 33 SMA patients randomized pilot trial (HU treatment for 8 weeks and     then follow up drug-free 8 weeks) to evaluate the effect of HU in SMA patients and we got a     promising preliminary data. We found that HU could significantly increase in the manual     muscle testing scores at 4 weeks, and full-length SMN mRNA level in the 30mg/kg/day subgroup     at 8 weeks relative to baseline, and it is safe under the dose 30mg/kg/day.      In this study, we plan to enroll 60 type II and III SMA patients and conduct a single-center,     randomized, double-blind, placebo-controlled, prospective trial of two-year duration to     evaluate the efficacy and safety of HU.The primary end points are the changes in full-length     SMN expression, SMN protein, motor function and lung function in SMA patients. We also design     a safety monitoring system to investigate the adverse effects and to assure the patients'     safety. We hope we can find and prove the efficacy and safety of HU in SMA patients and set     up a evaluating model for multi-center trials in the future.   "
201281|NCT00485524|"     Mortality after neonatal cardiac repair remains significant, and neonates who have undergone     operative repair of congenital heart disease may experience sudden and unexpected demise.     Most of these deaths occur within the first 72 hours and have been attributed to poor     systemic cardiac output. The literature currently does not define an early and reliable     predictor of poor post-operative outcome in children with congenital heart disease who have     recently undergone surgery.      The investigator wishes to perform a retrospective chart review to independently define the     predictive values of both NIRS score and serial serum lactate levels in the setting of early     post-operative morbidity.   "
201282|NCT00485537|"     Cycles with GnRH agonist and GnRH antagonist were compared and main outcome measures were the     number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical     pregnancy and miscarriage rates, were analized.   "
201283|NCT00485550|"     The purpose of this study is to evaluate the safety and tolerability of atomoxetine alone     versus atomoxetine plus low-dose, sustained-release MPH in children with treatment-resistant     ADHD.   "
201284|NCT00485563|"     This is a Phase 2 clinical trial to collect data on tumor responses produced by folate-hapten     conjugate therapy (vaccination with EC90 [KLH-FITC] and GPI-0100 adjuvant followed by     treatment with EC17 (folate-FITC) in combination with low-dose cytokines in patients with     progressive metastatic renal cell carcinoma. All patients will undergo imaging with the     investigational imaging agent 99mTc-EC20 (FolateScan) during the screening period to confirm     eligibility for the treatment portion of the clinical trial.   "
201285|NCT00485576|"     This study is to designed to test the role of complement in the late asthmatic response to     allergen challenge in mild asthma, as an indicator of the possible role of complement in the     broader asthmatic population.   "
201286|NCT00485589|"     This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in     combination with methotrexate in patients with active rheumatoid arthritis who are naive to     methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or     ocrelizumab 500mg i.v. on Days 1 and 15. Repeat courses of i.v. treatment will be     administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5     mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and     the target sample size is 500+ individuals.   "
201287|NCT00485602|"     The trial is aimed to investigate an orthodontic treatment with a new     removable-part-time-wearing appliance, based on High-Tech technology.      The appliance should be wear only 12-14 hours a day, and is made of a single silicone     aligner, made specifically for the patient, using 3-D screening technology of the patient's     malocclusion. The aligner has a designed pathway built-in for the tooth to move, from the     original position of the malocclusion to the end point - the correct position.      The force system, that is needed in order to generate tooth movement, is produced by tiny     air-balloons which are incorporated in the aligner.      The study hypothesis is, that an orthodontic treatment can be done successfully with this     part-time wearing appliance.   "
201290|NCT00485641|"     The purpose of this study is to determine what the potential utility of the Functional Tone     Management (F.T.M) Arm Training Program using the SaeboFlex in an inpatient stroke     rehabiliation hospital   "
201291|NCT00485654|"     Heterotaxy syndrome is a heterogeneous disease that is the result of a failure of normal     right-left lateralization of the abdominal and thoracic organs during development. The major     clinical manifestations include intestinal malrotation, functional asplenia and complex     cyanotic heart disease.      Hypothesis: There exists a yet, un-recognized, racial distribution in heterotaxy syndrome.   "
201292|NCT00485667|"     A reduction in the postoperative need for opioids to enhance the recovery process and     increase patient postoperative satisfaction.   "
201293|NCT00485680|"     The purpose of this trial is compare the efficacy of olanzapine and Lithium Carbonate in the     treatment of bipolar disorder, manic or mixed episodes, in Chinese patients.   "
201294|NCT00485693|"     Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee     arthroplasty   "
201295|NCT00485706|"     Renal patients have an increased risk for cardiovascular complications. There is also     increased vascular calcification and bone metabolism is similarly abnormal in patients with     chronic kidney disease.      In dialysis patients frequent episodes of hypercalcaemia occur. In a healthy bone structure     those episodes of hypercalcemia are buffered by the bone. The absence of bone buffering     capacity in dialysis patients can be a mechanism for vascular calcifications.   "
201296|NCT00485719|"     The purpose of this study is to determine the safety and tolerability of XL765. XL765 is a     new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies,     inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell     death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of     tumor cells.   "
201297|NCT00485732|"     Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.     The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to     cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK     Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
201298|NCT00485745|"     Given the relative lack of information regarding the risks associated with repeat sternotomy     in the pediatric patient population, a preliminary screen of the Children's Cardiothoracic     Surgery Database was performed to determine how many repeat sternotomies have been performed     at this institution within the last 4 years. A total of 1281 repeat sternotomies were     identified during this time period.      We propose a retrospective review of the indications, potential risk factors, and short-term     outcomes for these procedures. These data would allow a multivariable regression analysis to     identify risk factors associated with adverse events during repeat sternotomy.   "
201299|NCT00485758|"     A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant     versus placebo in Type 2 Diabetes Mellitus patients.   "
201300|NCT00485771|"     The purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine     comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar     depression.   "
201301|NCT00485784|"     This is a prospective multicentric study including four clinical units of Gynecology and     Obstetrics (3 public health hospitals and one private team), one research team in Hematology     and one Center of Clinical investigation (CIC).      The objective is to identify, beside the pregnancy, in a population of patients with a     preeclampsia (PE), with fetus presenting with growth restriction (IUGR) and a fetal demise     (FD) a modification of circulating endothelial biomarkers compared with normal pregnancy.      We want to understand better the physiopathology of preeclampsia and propose to patients with     an endothelial dysfunction a early prevention of preeclampsia.      Patients will be tested 3 times : At the pregnancy events; then 8 weeks and 12 months after     the birth.      Four groups will be constituted among patients: PE, IUGR, FD and normal pregnancy.      Normal pregnancy will be tested as controls. The next pregnancy presenting in the unit to     medical pregnancy follow up will be invited to participate.      The main judgment criteria will be the levels of endothelial microparticles 8 weeks after the     event.      The study will last 3 years. The number of patient to include is 280.   "
201383|NCT00486109|"     This study investigated wearability and usability of the I-PORT™ Injection Port (I-PORT™), a     new disposable injection port through which prescribed medication is injected subcutaneously     from a standard syringe or pen. Additional investigation compared subject opinion towards     using the I-PORT™ device compared to standard injection therapy.   "
201497|NCT00488241|"     To show efficacy of Zarzenda in the treatment of hand eczema   "
201302|NCT00485797|"     Experimental design overview The proposed project is a prospective experimental study design.     Children (age <15) suffer from attention deficit hyperactivity disorder (ADHD) that their     Parents willing to participate in the study will be tested with well-established measuring     techniques of Balance control before and 1 hour after taking of Methylphenidate (Ritalin) in     the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to     extract standardized stabilogram-diffusion parameters from each of the COP data sets     collected during quiet standing. These parameters include diffusion coefficients, critical     displacement, critical time and scaling exponents for both lateral and anterior-posterior     sway directions (Collins & De Luca, 1993). For each of the conditions (before and 1 hour     after the use of Ritalin) in three task conditions single task; dual task (concentrating and     identifying specific music); and just Listening to a relaxing music. Participants will be     required to stand on the platform 10 times for 30 s. For each trial, they will be instructed     to sway as little as possible.   "
201303|NCT00485810|"     The purpose of this study is to examine the clinical therapeutic dose in Japanese agitated     patients with schizophrenia.   "
201304|NCT00485823|"     The purpose of this study is to develop the weight management program, which is combined with     healthy diet, proper physical exercise, and behavior modification, related to patient's     quality of life. The patients groups are in routine practice with 5-20 mg olanzapine. The     study results may be utilized for patients who have gained weight on olanzapine and also     other antipsychotic drugs.   "
201305|NCT00485836|"     This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study     of the efficacy and safety of intravitreal ranibizumab compared with sham injections in     patients with macular edema secondary to central retinal vein occlusion (CRVO); 392 patients     with CRVO were enrolled at 95 investigational sites in the United States. The study included     a treatment period (6 months) and an observation period (6 months).   "
201306|NCT00485849|"     The primary purpose of this study is to evaluate the tolerability and effectiveness of     atomoxetine in the treatment of attention problems, hyperactivity, and impulsivity in     children with ASD, and secondarily, to evaluate the possible response to atomoxetine on the     core symptoms of ASD   "
201307|NCT00485862|"     The purpose of the study is to compare sertraline and atomoxetine/sertraline combination     therapy in patients with persistent depressive symptoms.   "
201308|NCT00485875|"     The purpose of this study is to assess changes in ADHD symptoms and tolerability of     medication in children and adolescents switching from a stimulant to atomoxetine.   "
201309|NCT00485888|"     To add to our understanding of the relationship between blushing, symptom severity and     potential mechanisms that underlie blushing in patients with SP, we propose comparing SP     patients' vascular responses to topical m-N pre and post treatment with S-citalopram or     placebo.      S-citalopram (an SSRI) has been widely used in the treatment of mood and anxiety disorders as     it has shown efficacy in these patients (Lepola et al., 2003; Stahl et al., 2003; Burke et     al., 2002; Davidson et al., 2002; Wade et al., 2002). In comparison to placebo, S-citalopram     has been shown to be effective and well tolerated in those with short and long term SP (Lader     et al 2004; Montgomery et al., 2003; Kasper et al., 2002). As indicated, responses to the     blushing exposure will be assessed prior to and following treatment with S-citalopram or     placebo and at one month following the intervention.      Levels of prostaglandin will be compared between groups and will also be correlated with     symptom severity in the clinical groups. Effective psychological interventions that reduced     the fear of blushing in individuals with social phobia did not lead to a reduction in actual     blushing during a social test (Mulkens et al., 2001). As such, it is expected that the     patients' perception of amount of blushing will change following treatment. In addition, we     are undertaking an investigation as to whether nican topical administration will change     following treatment to match the pattern seen in healthy controls.      The objectives are to evaluate the efficacy of S-citalopram 10 to 20 mg once daily (QD) in     the treatment of social phobia and to determine if treatment outcome is related changes in     intensity of the vasodilatory response to 10 mM topical m-N. This is a randomized,     double-blind flexible-dose study evaluating the efficacy, safety and tolerability of     S-citalopram 10 to 20 mg and placebo in outpatient subjects diagnosed with SP. At the     screening visit those who are eligible will enter a randomized trial with S-citalopram 10 to     20 mg and placebo. The study will begin with a single week of S-citalopram 10 mg.     Subsequently, capsules will be administered in a flexible dose fashion and patients will be     followed up weekly (biweekly after week 6) and at the clinician's discretion. After the first     week the patients' dosage will be increased up to a maximum of 20 mg daily. This dose will     remain fixed after 8 weeks of treatment until week 16.   "
201310|NCT00485901|"     The purpose of this study is to compare intramuscular Olanzapine and intramuscular     Haloperidol in changing of agitation in patients with schizophrenia   "
201311|NCT00485914|"     To determine if worksite based functional evaluation/intervention provided by occupational     therapists improves employment outcomes for persons with arthritis.   "
201312|NCT00485927|"     Medical practice & training are inherently stressful situations. However, the effects of     stress on educational & clinical performance are not well defined. The purpose of the current     study is to examine the effects of stress on performance of residents in simulated trauma     scenarios. The hypothesis is: 1) acutely stressful scenarios will be appraised as threat by     residents and result in elevations of heart rate and salivary cortisol; 2) increased     subjective & physiological stress will result in impairments in performance; and 3) greater     stress responses will result in greater clinical impairments.   "
201313|NCT00485940|"     The purpose of this study is to determine whether prucalopride is safe and effective in the     treatment of chronic constipation      Hypothesis:      Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the     treatment of patients with chronic constipation and is well tolerated in those patients   "
201314|NCT00485953|"     Elderly, postmenopausal women with breast cancer on aromatase inhibitors are at increased     risk of developing bone loss and osteoporosis. We postulate that in elderly, osteopenic     postmenopausal women who are on aromatase inhibitor therapy, bisphosphonate therapy will (1)     prevent bone loss at clinically relevant sites, such as the spine and hip and (2) decrease     bone turnover.   "
201315|NCT00485966|"     This is a Phase 2, open-label, multicenter, efficacy, safety, and pharmacodynamic study of     CX-3543 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL).   "
201316|NCT00485979|"     The primary objective of this study is to assess the pathological Complete Response (pCR)     rate by treatment arm (according to Chevallier criteria).      The secondary objectives are:        -  to assess in each treatment arm the clinical Response Rate (RR), the rate of breast          conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety          and tolerability profile, the pathological Complete Response rate (pCR) according to          NSABP and Sataloff criteria,        -  to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab          in Her2 +ve patients, according to the pCR rate.   "
201317|NCT00485992|"     Children's Healthcare of Atlanta (Children's) is collaborating with Child Health Corporation     of America (CHCA) in the nationwide effort to reduce catheter related blood stream infections     (BSIs). As well as the human cost, central venous catheter related bloodstream infections     significantly inflate hospital costs, mainly through increased length of stay in hospital,     particularly in intensive care (Jones, 2006).      The Cardiac Intensive Care Unit (CICU) is participating in this initiative by implementing     the BSI Bundles per the CHCA guidelines. BSI bundles are a group of patient care     practices designed to reduce BSI infection rates with implementation in patient care areas.     The bundles include recommendations for central line maintenance including line insertion,     dressing changes, line accesses, and monitoring for medical necessity. These bundles were     implemented on January 16, 2006, when the BSI rate in the CICU had peaked at 18.2 (rate of     infections per 1000 catheter days). The BSI rates historically for the past two years have     been highly variable (see attached graph for data from Jan. 04 through Oct. 06). The target     goal is to maintain a rate below 3.7 which has only been realized twice since the January BSI     bundle implementation.      Current practice for the care of central lines outlined in the BSI Bundles is based on the     Centers for Disease Control and Prevention (CDC) guidelines published in 2002. These     guidelines included important changes to practice involving the use of chlorhexidine (CHG)     containing products for improved infection prevention. CHG solutions are currently available     as either 2% or 3.15% chlorhexidine gluconate in a 70% isopropyl alcohol solution.      The Primary Aim is to determine if CHG is effective as an antiseptic wipe for accessing lines     to draw blood and administer medications. Compare the effectiveness of CHG containing alcohol     wipes (3.15% CHG/70% isopropyl alcohol) to plain alcohol in order to determine best practice     for the CICU.   "
201318|NCT00486005|"     Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with     schizophrenia who have been under treatment with olanzapine for at least two months and     evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent     adverse events, changes in vital signs, laboratory results and extrapyramidal effects.   "
201319|NCT00486018|"     This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study     of the efficacy and safety of intravitreal ranibizumab compared with sham injections in     patients with macular edema secondary to branch retinal vein occlusion (BRVO); 397 patients     with BRVO were enrolled at 93 investigational sites in the United States. The study included     a treatment period (6 months) and an observation period (6 months).   "
201320|NCT00486031|"     The objective of the study is to evaluate the long-term safety and tolerability of treatment     with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or     who have mildly to moderately active UC.   "
201321|NCT00486044|"     The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects     processes related to the development of Alzheimer's disease, including: 1) levels of a     substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood     flow in the brain, 3) inflammation in the brain, and 4) cognitive function.   "
201322|NCT00486057|"     The purpose of this study is to examine the outcomes of those who have received Daclizumab as     part of their immuno-suppression protocol following heart transplantation. Literature     suggests that the time to first rejection episode can be avoided or delayed by using     induction therapy.   "
201323|NCT00486070|"     This is a retrospective review of charts and echocardiograms of our patients with Total     Anomalous Pulmonary Venous Connection (TAPVC). The Children's Surgical and non-invasive Echo     databases will be used to determine all TAPVC patients. Children's Healthcare of Atlanta and     Sibley Heart Center Cardiology charts and echocardiograms of the TAPVC patients between     January 1, 2002 and November 26, 2006 will be reviewed. We anticipate approximately 40     patients.      We hypothesize that the presence of descending aortic flow reversal correlates with a higher     morbidity and mortality in TAPVC.   "
201324|NCT00486083|"     The purpose of the study is to compare atomoxetine hydrochloride and methylphenidate     hydrochloride in pediatric patients with ADHD.   "
201325|NCT00486096|"     Many children undergoing surgery for congenital heart disease have had prior operations.     Re-operative sternotomy carries with it the risk of cardiac injury and the need for emergent     peripheral cannulation.      Our first aim is to demonstrate that peripheral arterial cannulation may be lifesaving in     cases of complicated sternal re-entry in children and that angio-catheters can be utilized     when vessels are too small for standard cannulas.      Our secondary aim is to present a case report of successful femoral cannulation in a 5 kg     child.   "
201326|NCT00465283|"     This is a double blind randomized investigation of donepezil for patients suffering from     schizophrenia, undergoing ECT.      Patients will be randomized to receive either donezepil or plasebo, in order to gauge whether     donezepil has a protective effect on memory disfunction, while patients are treated with ECT.     Several parameters will be invistigated at baseline: general psychopathological measures,     memory function scales, side effects scales. The same measurements will be taken throughout     the trial and one month after ending the ECT.   "
201327|NCT00465296|"     The primary objective of this clinical trial is to assess the efficacy of rosiglitazone on     bare metal stent (BMS) in-stent restenosis measured as late lumen loss in patients with     metabolic syndrome.      The secondary parameter for evaluation of efficacy is binary restenosis.      The tertiary objective will be to assess the effect of rosiglitazone on major cardiac events     (MACE; death, MI, CABG, and target vessel revascularization). The occurrence of in-stent     restenosis for patients with metabolic syndrome who receive a DES in a non-target lesion will     be assessed angiographically at 9 months.   "
201328|NCT00465309|"     30% of ARDS patients ventilated according to NIH protocol presents morphological (CT) and     functional (Stress Index>1) conditions of hyperinflation even with Plateau pressure (Pplat) <     30 cmH2O; values of Pplat lower than 26 cmH2O were associated with more a condition of more     protective ventilation.      In patients at risk of hyperinflation, use of alternative techniques such as CO2-removal my     allow the reduction of Tidal Volume (Vt) and Pplat.   "
201329|NCT00465322|"     The purpose of the study was to determine the influence of fluvastatin and atorvastatin on     platelet aggregation in patients treated with aspirin and plavix after coronary stenting. We     hypothezied a positive effect of fluvastatin on platelet aggregation levels.   "
201330|NCT00465335|"     The purpose of this study is to evaluate the usefulness of performing a cat scan of the     heart arteries in patients (without a known history of heart disease) seen by their physician     for chest pain. We plan to evaluate this test in patients who have already undergone stress     testing. On occasion, stress test results are equivocal or suspected to be inaccurate. In     these cases, depending on the overall clinical suspicion of coronary artery disease,     physicians may recommend cardiac catheterization to determine whether or not patients have     blockages in their heart's arteries. We plan to evaluate whether a Cat Scan of the heart     arteries will provide your physician with important information to assist in this decision.     If the results of this test are normal, the patient may not require a heart catheterization;     alternatively, if the test is abnormal, a physician may proceed with catheterization after     review of the data. There will 200 patients enrolled into the study. All patients will be     followed by their usual cardiologist, and all decisions will be made by their cardiologist.      Computed tomography (CT; cat scan) is an x-ray test routinely used for diagnostic purposes.     Cardiac computed tomography using the newer generation multislice CT (MSCT) scanners is an     improved way of using CT scanning techniques to look at the heart and blood vessels of the     body. The images of the coronary arteries obtained by MSCT scanners (during a 5-10 minute     procedure) are highly accurate, when compared to the conventional invasive cardiac     catheterization procedure. This procedure will provide a calculation of a coronary artery     calcium score as well as an accurate depiction of the coronary anatomy. The accuracy of this     test is similar to that achieved with traditional stress test imaging, but has some inherent     advantages over this traditional stress testing. Therefore, we believe that in patients with     intermediate, inconclusive, or suspected inaccurate stress tests, MSCT of the coronary     arteries may provide helpful information to your physician to help guide their decision     regarding the need (or lack of) for possible invasive cardiac catheterization. This procedure     is considered an ideal screening test to exclude the presence of coronary artery disease in     patients with suspected coronary artery disease.      On the day of your procedure, the patient will be given intravenous (IV dye) contrast     during their Cat Scan. We will also draw a blood sample to assess your kidney function and/or     pregnancy status (if necessary). The contrast is what creates the pictures of one's arteries.     The intravenous contrast used is the same dye as that used for routine cat scans of other     parts of the body, as well as for cardiac catheterization. Prior to the Scan patients may be     prescribed a medicine called a beta blocker The beta blocker typically used is called     Atenolol. This medication slows your heart rate and is one that is commonly used to treat     high blood pressure. Dosing will be based upon your current medications and vital signs. If a     patient's heart rate is greater than 60 beats per minute an intravenous beta-blocker may be     given to optimize their heart images. Patient's will have to hold your breath twice, for up     to 30 seconds each time. The imaging part of the test takes about 10 minutes. Patient's will     be observed after the test for about 20 minutes, followed by discharge home. Physicians will     called with the patient's results of the study, and they will contact their patient's     regarding the results, as well as the next step. If a patient is a diabetic (taking     metformin/glucophage), we will request a follow up (the next day) kidney test. Patient's will     also will be called at 3 months to asked a few brief questions regarding your health (any     recent hospitalizations, any new medical illnesses, any follow up heart testing, etc.)   "
201331|NCT00465348|"     To quantify oxidative stress in circulating leukocytes of normal tension glaucoma patients,     prior to and one month after routine vascular therapy.   "
201332|NCT00465361|"     The purpose of this study is to evaluate the efficacy of individualized performance feedback     coupled with an educational module in improving resident performance of the physical and     developmental examination component of developmental surveillance of infants at the two month     preventive care visit.   "
201334|NCT00465387|"     Falls and osteoporosis-related fractures cause substantial morbidity and mortality in the     elderly, and are an increasingly important public health concern. A comprehensive     multidisciplinary and integrated community-based approach is needed to identify and manage     the population at highest risk of these complications. Unfortunately, current gaps in     continuity of care and health intervention result in a sub-optimal state of health service     for these individuals. The Falls, Fracture and Osteoporosis Risk Control and Evaluation     (FORCE) Study is a two-year randomized controlled trial evaluated on the effect of     coordinated community-based, multidisciplinary approach for fall and fracture prevention in     Sault Ste. Marie.   "
201335|NCT00465400|"     First, to quantify, by means of comet assay analysis, systemic oxidative stress in patients     with non-exudative and exudative age-related macular degeneration (AMD) and compare results     to healthy controls.      Second, to quantify systemic oxidative stress in patients with exudative AMD prior to and     after photodynamic (PDT) therapy.   "
201336|NCT00465413|"     The purpose of the present study is to determine whether use of a small volume spacer is     associated with better bronchodilatation in an unselected population of patients with     documented reversible airflow limitations.   "
201337|NCT00465426|"     HIV-infected patients treated with combination antiretroviral therapy demonstrate metabolic     abnormalities that may predispose them to cardiovascular disease. In HIV-infected patients we     will investigate progression rates of cardiovascular disease and assess whether these     progression rates are predicted by increased inflammatory indices.   "
201338|NCT00465439|"     This randomized controlled trial will examine the impact of local anesthetic on the frequency     of vasovagal reactions and the patients perception of pain during femoral arterial sheath     removal after percutaneous coronary intervention.   "
201339|NCT00465452|"     The purpose of this proposal is to determine if switching PD patients treated with     pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by     these patients. Side effects that we will monitor in particular include somnolence,     peripheral edema, cognitive decline with and without hallucinations. PD patients followed in     the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least     one of the following symptoms: somnolence, cognitive impairment with or without     hallucinations, or peripheral edema will be offered the opportunity to participate in this     study.   "
201340|NCT00465465|"     The dose of recombinant MVA used in the TB trials to date is relatively low compared with     other trials using recombinant MVAs which have used up to 2.5 x 108pfu (A Hill, personal     communication). Having demonstrated safety and immunogenicity of 5 x 107pfu of MVA85A, we now     need to perform a dose optimization study, prior to commencing larger scale Phase II and III     studies in South Africa. We will vaccinate 12 volunteers with a dose half a log lower than     the dose we are currently using, i.e. 107pfu MVA85A, and 12 volunteers with a dose half a log     higher, i.e. 108pfu.   "
201341|NCT00465478|"     The study evaluates the safety and efficiency of autologous bone marrow mononuclear cell     transplantation in treating patients with type 1 or 2 Diabetes Mellitus. We hypothesize that     autologous bone marrow stem cell transplantation will promote β-cells regeneration by     directly differentiated from the transplanted BMMCs or stimulated local stem cells     regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells     function.   "
201342|NCT00465491|"     Picoplatin is a new type of platinum drug that has been investigated in several clinical     trials, and may provide an improved safety profile over current treatment options. This study     is designed to compare the efficacy and safety of picoplatin plus Best Supportive Care (BSC)     with BSC alone. Best Supportive Care includes care and treatment to optimize the comfort of     patients and their ability to function, as well as to minimize the side-effects of     anti-cancer treatments.   "
201343|NCT00465504|"     Chronic arthritis (inflammation of joints) in children is known as Juvenile Idiopathic     Arthritis (JIA). Often, to control the swelling and to help reduce the pain in the joint,     medications (steroids) are injected into the joint. These injections are sometimes painful,     even if we use local anesthetics (lidocaine) to numb the skin; in fact, lidocaine injection     is often the most painful part of the procedure. There is an alternate method called     iontophoresis that uses an electric current to push lidocaine into the skin and deeper     tissues avoiding the anesthetic injection. Very little work has been done to see if this is     actually an effective way of numbing the skin in children having painful procedures such as     joint injections. In this study, we will compare two groups of children with JIA having     steroid injections into their joints: one group will get lidocaine by iontophoresis and the     other will get it by the usual injection method. We will assess the child's pain during the     steroid injection and compare the two groups to see if children who are given local     anesthetic by iontophoresis experience less pain. The results of this study will provide new     information about the effectiveness of the iontophoresis method, and whether or not this     would be a better way to give local anesthetic for children undergoing other kinds of painful     procedures.   "
201344|NCT00465517|"     The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone -     on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic     medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females     with catamenial epilepsy.      Catamenial epilepsy refers to a relationship between seizure frequency and a woman's     menstrual cycle, where the number of seizures increases around the time of a woman's     menstrual cycle.   "
201345|NCT00465530|"     Healthy children may develop symptoms of chronic sinusitis such as chronic cough, chronic     runny nose, nasal congestion, even headaches. Such symptoms may persist long after the child     gets over other symptoms of a cold and commonly result in the prescription of oral     antibiotics. The purpose of this study is to evaluate whether using saline alone or saline     plus an antibiotic (gentamycin) to irrigate the nose directly once a day for 6 weeks is     effective and safe for the treatment of the above named symptoms. Computerized axial     tomography (CAT) scans and quality of life surveys will be used to compare the health of the     sinuses before and after treatment, and scored to determine which of the two treatments,     saline alone or saline with gentamycin, is more effective in the treatment of this condition.     The study hypothesis is that intranasal saline irrigation will work as well as saline plus     gentamycin, and that majority of the patients will experience significant improvement after a     6 week treatment period.   "
201346|NCT00465543|"     The purpose of this study is to evaluate the safety and efficacy of a new treatment for nasal     polyps as compared to placebo (an inactive substance). The treatment involved is mint tea     high in rosmarinic acid. Rosmarinic acid is a polyphenol, or a chemical substance found in     certain plants such as oregano, rosemary, and the mints. It is the active ingredient in     spearmint. The placebo used in this study will be mint tea low in rosmarininc acid. In this     trial the amount of rosmarinic acid in the high rosmarinic acid tea, or study tea, will be     150mg. The placebo, or low rosmarinic acid tea, will contain 10mg of rosmarinic acid.   "
201347|NCT00476320|"     Myocardial deformation imaging allows analysis of myocardial viability in ischemic left     ventricular dysfunction. This study will evaluate the predictive value of myocardial     deformation imaging for improvement in cardiac function after revascularization therapy in     comparison to contrast-enhanced cardiac magnetic resonance imaging (ceMRI).      In 55 patients with ischemic left ventricular dysfunction, myocardial viability was assessed     using pixel-tracking-derived myocardial deformation imaging and ceMRI to predict recovery of     function at 9±2 months follow-up. For each left ventricular segment in a 16-segment model     peak systolic radial strain will be determined from parasternal 2D echocardiographic views     and the amount of late hyperenhancement (LE) and maximal thickness of myocardial tissue     without LE using ceMRI. The hypothesis is that compared with segments showing functional     improvement, those that failed to recover had lower radial strain and lower thickness without     LE and higher LE.   "
201348|NCT00476333|"     Introduction: Kinetic, kinematic and electromyographic activity of the lower limb have been     shown to be influenced by various footwear-generated biomechanical manipulations (e.g. soles.     Insoles, orthoses). A novel biomechanical device comprising four modular elements attached     onto foot-worn platforms was recently developed. Each element can be individually calibrated     (Position, convexity, height and resilience) to induce a specific biomechanical challenge.      Objectives: The aim of this study is to evaluate the influence of specific biomechanical     challenges on Kinetics, kinematics and electromyographic activity of the lower limb.      Design: Prospective, case control Setting: Motion analyses will be conducted during level     walking with (1) a three-dimensional motion analysis system and (2) ground reaction force     analysis using force platforms (3) Electro-Myography system. Each subject will be examined in     16 different settings of the biomechanical system   "
201349|NCT00476346|"     We conducted a double-blind, placebo-controlled randomized clinical trial of calcium and     vitamin D supplementation in 5201 female Naval recruits. During 8 weeks of basic training,     supplementation with 2000 mg calcium and 800 IU vitamin D/day decreased incidence of stress     fracture by 25%. The hypothesis was:      Supplementation with calcium 2000 mg/d and vitamin D 800 IU/d will significantly reduce the     incidence of stress fractures in female Navy recruits during 8 weeks of basic training.   "
201350|NCT00476359|"     To evaluate the pharmacokinetics (PK) of LPV/r with saquinavir in HIV-1 infected children. To     evaluate treatment response (clinical, immunological and virological) to LPV/r, SQV in Thai     children.   "
201351|NCT00476372|"     Background: Approximately 40% of patients with Parkinson's disease (PD) have cognitive     impairments. There is a lack of consensus as to the extent to which psychiatric symptoms,     depression, age at disease onset, disease duration, and medication is related to the type and     severity of cognitive impairment. This discrepancy can in part be caused by the lack of     distinction between patients with different motor symptoms and disease severity.      Objective: To identify the extent to which psychiatric symptoms, depression, age at disease     onset, disease duration, and medication is related to the severity and type of cognitive     dysfunction in patients with idiopathic PD categorized according to motor symptoms and     disease severity.      Methods: the population of patients with PD in the old county of Aarhus is described on the     background of medical records, and stratified in accordance to age, sex and cardinal     symptoms. Through proportional allocation a sample of a minimum of 50 patients with PD is     drawn from the population. The patients and 30 healthy matched controls will undergo     comprehensive neuropsychological assessment including tests of language, memory, executive     function, and visuospatial function. Furthermore, all participants will be screened for     depression (Geriatric Depression Scale) and psychiatric symptoms (Neuropsychiatric Inventory     and Symptom Checklist). The patients will be categorized in accordance with their motor     symptoms via cluster analysis for the purpose of analyzing the effect of psychiatric     symptoms, depression, and age of disease onset, disease duration, and medication on     cognition.   "
201352|NCT00476385|"     Primary objective:      to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for     MAXOMAT®, in children, for 1 year.   "
201353|NCT00476398|"     The purpose of this study is to find out how common diseases of the esophagus can cause chest     pain. Gastroesophageal reflux disease (GERD), commonly known as heartburn, is a common cause     of chest pain in patients that do not have heart problems. The study test is called PillCam     Eso, it is a small, pill sized capsule that has a small camera inside it. The camera will     take pictures of the esophagus and the stomach as it goes down. Findings of the PillCam Eso     will be compared to findings during conventional upper endoscopy.   "
201354|NCT00476411|"     The prevalence of Hepatitis B core antigen in the Thai population is about 70 %, no data of     isolated Hepatitis B core antigen is reported. Hepatitis B core antigen is observed in     10%-20% of individuals from low endemic areas of HBV infection. However, this prevalence of     isolated antiHBc would be higher in endemic area of HBV infection. There is conflicting data     of occult HBV infection in HIV infected patients. In Thailand, perinatal transmission is the     main route of transmission which is different from developed countries. Therefore, isolated     antiHBc in Thai people has longer duration than low prevalence regions. Moreover, HBV     genotype C and B is common in this region. If the HBV vaccination could eliminate an occult     HBV infection in these individuals, the liver related mortality might be reduced. The     prevalence and clinical importance of isolated antiHBc in Thai have not been investigated     yet. There is also limited data of HBV vaccine response in this setting.   "
201355|NCT00476424|"     A Pharmacokinetic study of once daily Efavirenz 400 mg versus 600 mg in Thai HIV-1 infected     subjects.   "
201356|NCT00476437|"     This trial is conducted in Japan. The purpose of this trial is to investigate the safety and     the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients     with type 2 diabetes mellitus.   "
201357|NCT00476450|"     This study will examine bacteria in patients mouths at different times during stem cell     transplantation and recovery. Drugs patients receive as part of the conditioning process for     a stem cell transplant increase their risk of infection. There might be a link between the     bacteria in the mouth and the bacteria that can cause infections. Knowing the changes in     bacteria might help researchers determine the best method to prevent infections.      Patients 18 years of age and older who are scheduled to receive a stem cell transplant may be     eligible for this study.      Participants undergo the following procedures:      Review of medical records      Interview about their oral care      Oral examination      Collection of oral specimens just before the stem cell transplant, immediately after the     transplant, and 3 weeks after the transplant. The specimens are obtained as follows:        -  <TAB>-About one-fourth teaspoon of saliva is collected with a suction device similar to          that used in a dental office.        -  <TAB>-Plaque from the surface of a tooth is collected with a plastic toothpick.        -  <TAB>-Skin cells from the inside of the cheek and the surface of the tongue are          collected with a small soft brush.        -  <TAB>-If a tube is inserted into the patient s lungs to assist breathing and the patient          is admitted to the intensive care unit, a specimen from the lungs is collected.      Patients are followed for 100 days after their transplant. Additional oral specimens are     obtained from those who develop signs and symptoms of respiratory infection.   "
202169|NCT00493285|"     The overall objective of the MEDI-534 clinical development program is to evaluate the safety,     efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in     young infants.   "
201358|NCT00476463|"     Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce     emergence of resistant strains. Several new therapeutic agents are currently in development,     however combination therapy trials in the HBV-infected population have only recently     commenced. No such trials have been undertaken in the HIV/HBV co-infected population.   "
201359|NCT00476476|"     In this research study we are looking to see how vulvar cancer responds to erlotinib therapy.     Two distinct patient populations are targeted: women with locally advanced measurable     squamous cell carcinoma of the vulva, primary or recurrent, who are candidates for definitive     treatment with surgery or chemoradiation (Cohort 1) and women with radiographically     measurable distant metastatic cancer either at time of presentation or with recurrence     (Cohort 2). Another goal of this study is to learn more about the proteins and genes present     in vulvar cancer and how they may affect response to erlotinib. Erlotinib treats cancer by     preventing cancer cells from growing and multiplying. It does this by blocking certain     proteins that are on the surface of some types of cancer cells. Laboratory tests show that     vulvar cancer cells have high levels of these proteins.   "
201360|NCT00476489|"     The purpose of this study is to determine if topical steroids treatment for different skin     diseases suppress the adrenal cortisol production.   "
201361|NCT00476502|"     Study of genetic polymorphisms of CYP #A and MDR-1 genes in Thai HIV-1 infected patients on     saquinavir/ritonavir.   "
201362|NCT00476515|"     Primary Objectives:        -  Conversion of a positive donor specific cross-match to a living donor to a negative          cross-match thereby allowing successful renal transplantation.        -  Transplant success or failure following the desensitization protocol.        -  Determination of the effect of rituximab on the kinetics of donor specific antibodies          (DSA).        -  Determination of the effect of rituximab on the kinetics of B-cell subpopulations in          peripheral blood and/or secondary lymphoid organs (lymph node biopsies at time of          transplant, if available) in both responders and non-responders using flow cytometry          and/or immunohistochemistry.      Secondary Objectives:      -Decrease in incidence of humoral rejection to less than 50 % at 1 year.   "
201363|NCT00476528|"     The purpose of this study is to investigate if a systematic intervention with early     identifying of patients with posttraumatic amnesia using a reality orientation therapy can     reduce the period with posttraumatic amnesia in order to get a better outcome for patients     with traumatic brain injury   "
201364|NCT00476541|"     The overall objective is to improve the cure rate of children with newly diagnosed acute     myeloid leukemia (AML) who undergo risk-adapted therapy.      Stem cell transplantation (SCT) is reserved to high-risk patients defined by cytogenetics and     response to chemotherapy. The efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg)     will be evaluated.   "
201365|NCT00476554|"     This is an open label, randomized phase II study designed to evaluate the tolerability and     response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell     lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2     systemic therapies.   "
201366|NCT00476567|"     There is a great lack of results from randomized clinical trials with high methodological     quality, assessing the effects of exercise during pregnancy. The main aims of this trial is     to study the effects of exercise during pregnancy in the prevention and treatment of disease     and complications which may arise during pregnancy:        -  Does regular exercise during pregnancy aid in preventing gestational diabetes?        -  Does regular exercise during pregnancy prevent low back and/or pelvic girdle pain?        -  Does regular exercise during pregnancy prevent urine and/or fecal incontinence?        -  Does regular exercise during pregnancy have an effect on labour and delivery?        -  Does regular exercise during pregnancy prevent maternal excessive weight gain and fetal          macrosomatia?   "
201367|NCT00476580|"     Objectives:      General objective:      To determine how acculturation to United States has influenced the health and cancer risk     among a US migrant Sri Lankan population.      Specific objectives:        1. To determine the prevalence of cancer and cancer related non-communicable diseases among          Sri Lankan Sinhalese living in the greater Houston area.        2. To study the distribution of risk factors for cancer in this population.        3. To study the pattern of utilization of methods available for early detection of cancer          in this population.        4. To study and compare the findings of this survey with that of the siblings of this          population living in Sri Lanka.   "
201382|NCT00476801|"     The purpose of this investigation is to evaluate the effectiveness of an investigational     device which is similar in appearance to a tanning bed but which emits ultraviolet     irradiation of a specific wavelength known as UVA1. This device has not been approved by the     FDA for general use in this country, as yet, but it has been used quite successfully in     Europe for several years in treating such conditions as scleroderma, keloids, and other     fibrosing conditions of the skin. Your participation in this study may yield important     information regarding the safety and effectiveness of this form of light therapy for the     treatment of these skin conditions which, at present, are difficult to treat.   "
201368|NCT00476593|"     Retinal optical coherence tomography (OCT) is an established technology which enables a     detailed cross-sectional visualization of the retinal micro-anatomy, and an objective     measurement of its thickness in-vivo. Multifocal electroretinogram (MfERG) measures function     of the central retina. Both technologies are relatively new and they provide complimentary to     each other information on retinal anatomy and function.      The aims of this study is to establish normal ranges for OCT and mfERG measurements related     to age, gender and reproductive factors such as parity and the use of contraception in     Norwegians; to assess the presumably healthy central retina with the use of anti-inflammatory     medication with relation to age and sex ; to study the frequency and extent of retinal     thickening and change in retinal function in patients with anterior uveitis not complicated     with macular edema; to assess whether the presence of the HLA-B27 haplotype or uveitis     recidive affects macular thickening/function in uveitis.   "
201369|NCT00476606|"     To evaluate clinical and immunological outcome of children treated with HAART.   "
201767|NCT00482001|"     The goal of the study is to assess the role of cholinesterase inhibitors in affecting the     driving ability of cognitively intact seniors using driving simulators. We hypothesize that     the use of a cholinesterase inhibitor for two weeks will be associated with improvement in     safe driving behavior on a simulated driving task.   "
201370|NCT00476619|"     Full Title: A Randomized Controlled Trial of Procrit for the Prevention of Acute Renal     Failure in Patients Receiving Intravenous Contrast      Primary Objective: To evaluate the efficacy of a one-time dose of intravenous erythropoietin     administration in the prevention or attenuation of contrast-induced acute renal failure.      Secondary Objectives: To evaluate serum and urinary markers of renal injury, including KIM-1,     BMP-7, and TGF-b, along with other biomarkers, in subjects receiving intravenous contrast and     correlate their expression with clinical outcomes      Study Design: Prospective, multi-centered, randomized, double blind, placebo controlled trial     of a one-time dose of EPO. Subjects will be followed for seven days or until hospital     discharge, whichever is longer. Total estimated study duration 3 years.   "
201371|NCT00476632|"     The goal of this research study is to identify biologic and lifestyle factors that may     increase a person's risk of developing certain types of cancer.   "
201372|NCT00476645|"     The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of     tumor progression in patients who have developed androgen-independent (AIPC) or     hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific     antigen (PSA).   "
201373|NCT00476658|"     Quantification of macrophage infiltration and characterization of macrophage phenotype in     adipose tissue of 60 obese subjects and 20 non obese subjects   "
201374|NCT00476671|"     To assess the prevalence and risk factors of neurocognitive impairment and psychiatric     comorbidities in HIV infected patients who have undetectable viral load, have been on HAART     for at least 1 year and have no history of CNS infection.   "
201375|NCT00476684|"     There is conflicting evidence on whether radio-frequency neurotomy of the medial branch has a     significant effect on pain in patients with chronic unilateral facet joint neck and back     pain.      We will evaluate radiofrequency treatment on medial-branch of the ramus dorsalis as an     effective pain treatment for patients with chronic pain originated from facet-joints in     cervical and lumbar columna.   "
201376|NCT00476697|"     The purpose of this investigation is to evaluate the effectiveness of high-dose UVA1     irradiation in the treatment of fibrosing conditions of the skin, e.g., keloid (a thick scar     from growth of fibrous tissue), scleroderma (deposits of fibrous tissue in the skin) and acne     keloidalis nuchae (keloids on the back of the neck or hairline) old burn scars, granuloma     annulare or other similar skin conditions. This UVA1 dosing schedule has been used     successfully in Germany for various skin diseases, such as the above mentioned scleroderma.   "
201377|NCT00476710|"     This project will compare the amount of bile acids and their kinetics in overweight and obese     people with normal glucose metabolism, impaired glucose tolerance and frank type 2 diabetes.     We hypothesize that bile acids will behave differently in these groups. We will also explore     the effects of Colesevelam HCl, a medicine that lowers LDL cholesterol by binding bile acids,     on bile acids in those groups. We hypothesize the drug may have different actions on bile     acids in subjects with different degrees of abnormal glucose metabolism.   "
201378|NCT00476723|"     The trial will randomise HIV/HBV co-infected individuals to different HBV-active     antiretroviral therapy treatment regimens.   "
201379|NCT00476736|"     Treatment of COPD patients depends on the stage of the disease. First of all it is strongly     recommended quit smoking, then bronchodilators drugs are added. In more advanced stages     inhaled corticosteroids and pulmonary rehabilitation are added. In hypoxemic patients a long     term supplemental oxygen is advised.      The addition of sputum modifiers drugs is equivocal, since no objective improvement was     documented.      N-Acetylcystein (NAC) is a drug known for its anti-oxidant and mucolytic activity. In animal     models of disease it showed its beneficial activity , whereas in human such changes weren’t     demonstrated. In all the studies FEV1 was used to demonstrate the beneficial effect of the     drug, although the disease changes are at the level of small airways which is almost not     expressed by the measurement FEV1.      Purpose of the study        1. To estimate the damage severity at the small airways.        2. To estimate the change in quality of life.        3. To assess the pulmonary function changes at rest and following exercise, including          parameters of air trapping (hyperinflation)      Methods & Materials Patients – Inclusion - 30 Moderate COPD (GOLD classification) , AGE     45-70, both sexes. Treated with inhaled steroids and long acting beta agonists.      Exclusion – Active ischemic heart disease, heart failure, orthopedic problems that preclude     ergometric bicycle activity.      Questionnaire – The St. George questionnaire for quality of life will be used . Pulmonary     function testing- Lung volumes and spirometry un including inspiratory capacity will be     measured before and after exercise.      Study protocol – 2 weeks run in, for observation disease stability and drug adherence.      Patient will randomly separated in 2 groups . Group A – will receive 600-1200 mg N-acetyl     cystein twice daily. Group B – will receive as control placebo . Following 4 weeks of     treatment patient will clinically re-examined and PFT's performed as described. After 2 weeks     of washout group A. will serve as control and group B. will be treated with NAC as described.   "
201380|NCT00476775|"     A randomized controlled trial to test the efficacy of an after school ethnic dance program     plus a culturally-tailored, home-based screen time reduction intervention to reduce weight     gain (body mass index) among lower socioeconomic status, pre-adolescent Latina girls.   "
201381|NCT00476788|"     This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII)     therapy in young children using a novel delivery method in the form of a self-contained,     lightweight, and disposable insulin pump unit controlled with a wireless handheld device. The     outcomes of interest are the feasibility and potential metabolic benefits of this approach.     We anticipate that the initiation of this CSII device in the immediate post-diagnosis period     in this population will result in good glycemic control and greater parental satisfaction     when compared to intensive insulin injection therapy.   "
201385|NCT00486135|"     The purpose of this study is to evaluate the safety and tolerability of XL147 in subjects     with solid tumors or lymphoma. Both a capsule and a tablet formulation will be evaluated.     XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown     to inhibit growth and induce apoptosis (programmed cell death) in tumor cells.   "
201386|NCT00486148|"     The purpose of this study is to determine the safety and efficacy of an infant formula     supplemented with a prebiotic component (GOS) in improving the gut microflora balance,     mimicking that of breast-fed infants.   "
201414|NCT00487149|"     Respiratory muscle strength is used as an outcome measure in intervention studies. There are     reference values for respiratory muscle strength in 'healthy' people but not in those with     bronchiectasis disease. The aim of this study is to investigate the reliability of     respiratory muscle strength measurements and identify reference values for those with stable     moderate to severe bronchiectasis disease.   "
201768|NCT00482014|"     The primary purpose of this study is to determine the 2-year survival rate of both of the     chemotherapy regimens in patients with inoperable non-small-cell lung cancer.   "
201387|NCT00486161|"     Ghrelin is a GH-secretagogue gastrointestinal hormone that regulates feeding behavior by     interacting directly with hypothalamic centers in concert with other negative and permissive     neuromodulators. Ghrelin is involved in controlling energy balance in the short-term and     long-term, and its levels are inversely related to the degree of obesity, insulin-resistance     and energy accumulation. Consequently, obesity bears decreased ghrelin levels which increase     upon weight loss, energy depletion and long-term exercise programs. Nevertheless, the role of     acute exercise on the secretion of the bioactive component of ghrelin is yet unknown in     conditions of normal and excessive body weight.      Our study examines acylated and total ghrelin secretion following a cycloergometric exercise     test in obese and age- and sex-matched lean subjects to document if ghrelin components change     as a function of fat accumulation, insulin homeostasis, growth hormone secretion,     non-esterified fatty acid availability and exercise performance. Our study aims at testing     the hypothesis that ghrelin components may be regulated by acute exercise, with     concentrations at the exercise peak being related to acute metabolic homeostasis. Targetting     this purpose may help to clarify ghrelin involvement in acute conditions unrelated to     gastrointestinal activities.   "
201388|NCT00486174|"     The purpose of this study is to investigate whether the addition of Methylene Blue to the     standard treatment of septic shock will reduce vasopressor requirements   "
201389|NCT00486187|"     The purpose of the ROSITEL study is to assess the effects of rosiglitazone, as compared to     standard oral therapies for diabetes (metformin/sulfonylurea), on inflammatory markers and     adipokine levels in diabetic patients using an angiotensin receptor blocker (ARB).      We hypothesize that ARB-treated diabetic patients receiving rosiglitazone will experience     greater reductions in vascular inflammation and levels of leptin and resistin, associated     with increased adiponectin levels, compared to a metformin/sulfonylurea regimen, and that     these benefits will result in part, from greater improvements in insulin sensitivity in the     rosiglitazone group.   "
201390|NCT00486200|"     A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.   "
201391|NCT00486213|"     RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients     with cancer. It is not yet known whether pyridoxine is more effective than a placebo in     preventing hand-foot syndrome in patients with cancer.      PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works     compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients     with cancer.   "
201392|NCT00486226|"     The objective of the registry is to evaluate the real world safety and performance of the     CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate     endovascular coil embolization of intracranial aneurysms.   "
201393|NCT00486239|"     The purpose of the study is to assess the effects of temporal lobe epilepsy (TLE) on memory     and emotional functioning. The study will evaluate the known lateralized neurological     dysfunction(Right TLE versus Left TLE) on emotional verbal and visual memory function. Study     data will assess the ability of participants with known lateralized neurological dysfunction     (Right TLE versus Left TLE) to differentially perceive emotional stimuli. Another component     of the study will evaluate possible changes in memory function for emotionally charged     material following right or left temporal lobectomy for the treatment of medically     intractable epilepsy. It is expected participants with known lateralized dysfunction will     exhibit differential ability to discriminate emotional charged visual and verbal material.   "
201394|NCT00486252|"     The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over     3 months. The secondary objective is to study the other efficacy parameters during treatment     for 3 months   "
201395|NCT00486265|"     The primary purpose of this study is to find out what the maximum tolerated dose is for an     experimental drug called AZD4877 based on the side effects experienced by patients that     receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML).      For enrollment information see the Central Contact information below   "
201396|NCT00486278|"     This trial is conducted in Africa, Asia, Europe, Japan, and North and South America.      The aim of this trial is to evaluate the safety and efficacy of activated recombinant human     factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.   "
201397|NCT00486291|"     The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to     placebo in the glycemic management of obese diabetic adults.   "
201398|NCT00486304|"     RATIONALE: Eating a diet that is low in antioxidants may control cachexia in patients with     oropharyngeal cancer.      PURPOSE: This randomized phase I trial is studying the side effects of a low antioxidant diet     in controlling cachexia in patients with oropharyngeal cancer receiving chemotherapy and     radiation therapy.   "
201399|NCT00486317|"     The purpose of this study is to expose patients with OA to calcitonin and to determine plasma     calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin and 200 IU nasal     calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin     (0.6 mg and 0.8 mg oral) and 200 IU nasal calcitonin compared to placebo on serum CTX-I and     CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral     calcitonin compared to placebo.   "
201400|NCT00486330|"     The main purpose of this study is to examine the effect of tipranavir combined with     ritonavir, medications for the treatment of HIV-infection, on buprenorphine/naloxone (BUP) in     people who have been receiving the same dose of buprenorphine/naloxone for at least 3 weeks     before study entry.   "
201639|NCT00480272|"     Hypothesis: Early intensive treatment with anti-TNF agent plus methotrexate plus high dose     prednisone may increase remission rate and may induce stable remission in Rheumatoid     Arthritis Objective: to evaluate induction of remission using adalimumab, prednisone and     methotrexate and maintenance of remission after discontinuation of adalimumab and prednisone   "
201436|NCT00487435|"     The purpose of the study is to assess the long-term safety profile of Tapentadol (CG5503)     extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients     with moderate to severe chronic pain over a period of 1 year. The study will also assess     dosage requirements over the long term; characterize adverse events and tolerability, sleep     quality, and potential symptoms of withdrawal; characterize pain intensity scores and overall     impression of change; and characterize patient-related health outcomes.   "
201401|NCT00486343|"     Asthma is a chronic inflammatory disorder of the airways with a variety of inflammatory     processes contributing to the pathogenesis. The inflammation leads to a state of increased     airway responsiveness and reversible airway obstruction that causes the recurrent symptoms of     asthma. Despite the variety of treatments available for asthma, none are curative, and the     disease continues to place a burden on society in terms of morbidity, reduced quality of life     (QOL), and ever increasing healthcare costs. The prevalence of asthma continues to increase     with current data suggesting that since 1980, adult asthma cases have increased by 75% and in     children under 5 years of age the prevalence has increased by 160%.1 Additionally, studies     have suggested that the disease severity has been underestimated and that more patients may     be classified as having moderate to severe persistent disease.2 Inhaled corticosteroids (ICS)     have been the cornerstone of anti-inflammatory treatment for decades and have been shown to     improve lung function, decrease symptoms, and reduce asthma exacerbations.3 However, many     patients are still inadequately controlled despite treatment according to current asthma     management guidelines and have a significant unmet medical need. Such patients are at high     risk of serious exacerbations and asthma-related mortality.4 Combining long-acting     β2-agonists (LABAs) with low dose ICS has been shown to improve asthma control over using     higher doses of ICS alone. However, LABAs act mainly at the bottom of the inflammatory     cascade and there are concerns that they may mask underlying inflammation.5 Recently,     leukotriene receptor antagonists have been added to ICS as second-line therapy in the     management of asthma. Zileuton has been extensively studied in inflammatory diseases such as     asthma, in which leukotrienes mediate inflammation.      The aim of this study is to assess the effect of zileuton controlled-release (CR; 1200 mg     2-times daily [BID]) on pulmonary function, asthma control, and symptomatic response in adult     patients with asthma poorly controlled on moderate dose ICS.   "
201402|NCT00486356|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, epirubicin, and carboplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when     given together with epirubicin and carboplatin in treating patients with progressive,     unresectable, or metastatic cancer.   "
201403|NCT00486369|"     The purpose of this study is to expose patients with OA to calcitonin and to determine plasma     calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin. Also the purpose     is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral)     compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of     different doses/formulations of oral calcitonin compared to placebo.   "
201404|NCT00486382|"     The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe     and whether it can or cannot produce a protective response against visceral leishmaniasis     when injected to healthy subjects.   "
201405|NCT00486395|"     In Canada each year, there are approximately 800 infants born between 28 and 32 weeks     gestation. Up to 60% of these infants will require breathing tube placement for Respiratory     Distress Syndrome or RDS. RDS is a lung disease of prematurity due to a lack of a compound     called surfactant. The breathing tube is placed as a conduit for placing surfactant into the     babies' lungs to improve the lung disease. Most babies are then placed on a breathing machine     or ventilator. Ventilation is not without harm and can be associated with lung damage, delays     in feeding, increased hospital stay and interruption of bonding. An alternative that does not     require the presence of a breathing tube is Continuous Positive Airway Pressure (CPAP). We     will randomize babies to either ventilation or CPAP to try to minimize the length of time the     baby is kept on respiratory support.   "
201406|NCT00486408|"     The purpose of this study is to intensively characterize the immune response, particularly     the T-cell response, to a three-dose regimen of an adenovirus-based HIV-1 vaccine in     HIV-uninfected adults.   "
201407|NCT00486421|"     RATIONALE: Rituximab and prednisone may increase the number of platelets in patients with     immune thrombocytopenic purpura.      PURPOSE: This phase II trial is studying the side effects and how well giving rituximab     together with prednisone works as first-line therapy in treating patients with immune     thrombocytopenic purpura.   "
201408|NCT00486434|"     The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon     calcitonin in the treatment of patients with osteoarthritis of the knee.   "
201409|NCT00487084|"     Epidural chloroprocaine is often used in obstetrical anesthesia because of its fast onset and     short duration. These properties make it an ideal drug to use for epidural anesthesia in     patients undergoing postpartum tubal ligation. When epidural morphine is given after     chloroprocaine, there is a decreased efficacy of analgesia as compared to lidocaine (1).     Several studies have hypothesized a specific opioid receptor mediated antagonism of     chloroprocaine (2,3). Karambelkar raised the question whether this decreased efficacy is due     to a disparity between the time the chloroprocaine anesthesia resolves and the onset of     epidural morphine analgesia, resulting in a time window of pain (2). The duration of action     of epidural 2-CP anesthesia is 30-45 minutes and the onset of epidural morphine analgesia is     60-70 minutes, therefore the regression of sensory blockade before the onset of the morphine     analgesia could result in a window of pain (2). Hess and colleagues studied epidural morphine     analgesia and women who had a Cesarean delivery under spinal bupivacaine anesthesia (3).     Subjects were randomized to receive epidural 2-CP and morphine or epidural saline and     morphine. There was no difference in postoperative analgesia between the two groups (3 and     personal communication, Dr. Philip Hess). A literature search cross referencing epidural     chloroprocaine, using Pub Med, did not produce any articles comparing epidural morphine given     before the procedure (in an attempt to time the onset of analgesia with the resolution of     chloroprocaine anesthesia) to the standard administration time after the procedure.   "
201410|NCT00487097|"     The purpose of this study is to investigate whether the addition of omega-3 and antioxidants     to nutritional support in critically ill patients in the intensive care unit influences the     immune and anti-inflammatory systems and so improves wound healing.   "
201411|NCT00487110|"     A previous study has shown that tropisetron inhibits the analgesic effect of paracetamol in     healthy volunteers. This study aims at confirming this pharmacodynamic interaction in     patients with post-surgery pain.   "
201412|NCT00487123|"     This study will evaluate the efficacy of the reminder device Remind Cap® in improving     patients' compliance in the consumption of Valsartan +/- Hydrochlorothiazide (HCTZ) in the     treatment of hypertension   "
201413|NCT00487136|"     This is a multiple-dose, double-blind, randomized, single-center, parallel-group study in     adult male subjects in general good health.   "
201640|NCT00480285|"     The aim of this study is to compare the effectiveness of laparoscopic Nissen against anterior     partial fundoplication in the control of gastroesophageal reflux disease among Chinese     patients      Study hypothesis Laparoscopic Nissen is comparable to anterior partial fundoplication in the     control of gastroesophageal reflux disease   "
201415|NCT00487162|"     Surgery induces a stress effect on the body partially through a catabolic energy state. In     turn, glucose levels may rise to levels which have been associated with major morbidity     (Golden, 1999) and mortality (Ouattara, 2005). An increasing body of evidence suggests that     intensive insulin therapy for tight control of blood glucose levels in certain surgical and     critical care patient populations may improve mortality and selected morbidity outcomes when     compared to those patients receiving conventional insulin therapy and blood glucose     management. More specifically, poor intra-operative blood glucose control is associated with     worse outcome after cardiac surgery. Intensive insulin therapy with tight blood glucose     control in surgical patients while in the ICU may reduce morbidity and mortality. Such     outcome improvements would clearly provide benefits to patients, providers and payers. To     date, there is scant research examining whether intensive insulin therapy for tight control     of blood glucose in the perioperative period can alter outcomes for the non cardiac surgery     population. The purpose of this study is to determine whether intensive insulin therapy for     tight control of blood glucose in the perioperative period in non cardiac major surgery     patients is associated with altered morbidity and mortality rates.   "
201416|NCT00487175|"     Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for     example in neuropathic pain is not very well known. This protocol aims therefore at studying     the effect of tramadol in a human pain model with sensitization induced by a cold stimulus,     using evoked potentials to elucidate how pain is modified when tramadol is administered.   "
201417|NCT00487188|"     To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with     HAART alone in achieving and maintaining viral load suppression.   "
201418|NCT00487201|"     Background and Study Aims: Biliary strictures are a major cause of morbidity following liver     transplantation with an overall incidence between 10 and 30 %. Up to now biliary strictures     were dilated subsequently one to three plastic stents with a diameter of eight to ten F were     inserted. In general, stents were exchanged in two to three months intervals over one year.     In the present prospective controlled study, efficacy and complication rates of balloon     dilation have been compared with dilation plus stenting.      Patients and Methods: XY patients with high-grade biliary strictures (anastomotic and     non-anastomotic) were enrolled in this prospective study in random order. X patients were     treated by endoscopic balloon dilatation and Y by balloon dilatation plus plastic stent     placement in six to eight weeks intervals. The primary end point was permanent opening of the     biliary obstruction of 12 months. Number of endoscopic interventions and complications of the     procedures were monitored.   "
201419|NCT00487214|"     The purpose of this study is to evaluate the range of target IOPs set for glaucoma patients     starting monotherapy with bimatoprost and to evaluate patient and physician satisfaction with     bimatoprost in real-world settings   "
201420|NCT00487227|"     It is often assumed that levels of caffeine found in 'decaffeinated' beverages are below any     psychopharmacological threshold. However, recent findings indicate that caffeine doses as low     as 9 mg may be psychoactive. The effects of caffeine have also been shown up to 6 hours     post-administration. The study aimed to establish the lowest active dose of caffeine, and to     ascertain the duration of any effects.   "
201421|NCT00487240|"     The purpose of this study is to examine the efficacy and safety of insulin lispro protamine     suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime     insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for     sequentially testing the secondary objectives.   "
201422|NCT00487253|"     The purpose of this randomized, open label clinical trial is to determine if oral miltefosine     is a safe and effective alternative, compared with parenteral meglumine antimoniate for the     treatment of pediatric Cutaneous caused by L. Viannia species in Colombia.   "
201423|NCT00487266|"     The goal of this proposal is to test the overall hypothesis that subjects with chronic or     recurrent low back pain have an abnormal soft tissue response to acupuncture needling, and     that this altered response is associated with abnormal perimuscular connective tissue     structure and biomechanics. We will also test whether or not altered needling responses in     low back pain are generalized, or localized to specific locations as predicted by traditional     acupuncture theory. This proposal is part of a series of projects investigating the role of     connective tissue in the mechanism of acupuncture and, in addition, constitutes a first step     in examining the role of connective tissue in low back pain. Acupuncturists describe     qualitatively different needling responses at locations believed to be involved in the     patient's disease process. Although assessing abnormalities in the needling response is a     fundamental aspect of acupuncture therapy, what constitutes a normal vs. abnormal needling     response has never been studied quantitatively. Thus the nature of tissue changes underlying     these phenomena remains unknown. We have recently developed a new in vivo technique based on     ultrasound elastography that allows visualization and quantification of tissue displacement     and strain patterns developed in tissues during needle manipulation in humans [1] (Appendix     A). In this proposal, we will use ultrasound elastography, ultrasound image analysis and     biomechanical modeling to perform 1) quantitative measurement of soft tissue behavior during     needling and 2) detailed analysis of perimuscular connective tissue structure and     biomechanics in human subjects with and without low back pain.   "
201424|NCT00487279|"     This trial is a prospective, multi-center, randomized study of patients with coronary artery     disease (CAD) and mild to moderate left ventricular (LV) dysfunction. The primary objective     of this study is to test the hypothesis that Implantable Cardioverter Defibrillator (ICD)     therapy in combination with medical therapy in patients with an infarct size greater than or     equal to 10% of the left ventricular mass improves long term survival compared to medical     therapy alone. In addition to the 2-arm randomized trial, the study will also include a     non-investigational registry of non-randomized patients.   "
202114|NCT00486551|"     This is a clinical study of a cognitive-behavioral therapy known as anger control training in     adolescents with Tourette Syndrome and explosive, disruptive behavior. ACT is compared to     treatment as usual (TAU) in a randomized clinical trial.   "
201769|NCT00482027|"     The purpose of this study is to determine safety and immunogenicity (ability to induce an     immune response) of a novel HIV vaccine based on adeno-associated virus (AAV)   "
201425|NCT00487292|"     Design: paired trials without and with naps and bright light. Setting: Real driving on a     private road circuit. Environmental controlled car. Participants: 9 shift workers on tree     shifts (morning-afternoon-night) Measurements: Sleepiness at the wheel was measured by     ambulatory polysomnography and assessed using 30 seconds segments of recordings when the     percentage of theta EEG was at least 50% (15 seconds) of the period recorded. Subjects were     also called to rate their sleepiness on the 7-point Stanford Sleepiness Scale (SSS).      Intervention: Participants drove the same car on two similar 24 hours periods of work, with     three pilots in each shift (morning, afternoon, night), separated by three weeks. During the     baseline period, the subjects were told to manage their rest as they usually do in the real     life. During the second experimental period, they had to rest lied in a dark room during two     naps of 20 minutes and then exposed to bright light pulse (5000 lux) during 10 minutes.   "
201426|NCT00487305|"     The purpose of this study is to compare the safety and immune activity of three doses of     tumor vaccine. In recent years, researchers at the Dana-Farber Cancer Institute have     discovered that vaccines made from patient's own cancer cell, that have been engineered in     the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful     immune response specific to that cancer. GM-CSF is a naturally occuring hormone in the body     that helps our immune system fight infections and diseases. One of the goals of this study is     to determine whether these vaccinations will improve the immune system's ability to recognize     and destroy the participant's lymphoma cells.   "
201427|NCT00487318|"     Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy.     Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans     Administration. It is a randomized control format including genotypes 1 and 3. There will     also be pilot arms for HCV carriers who present for screening already on a statin, who will     be allowed to stay on their current statin or switched to another statin. In all ways,     standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package     insert.   "
201428|NCT00487331|"     The goal of this clinical research study is to learn if using acupuncture with or without     electrical stimulation in cancer patients with high levels of pain can help to relieve the     pain.   "
201429|NCT00487344|"     The purpose of this study is to compare the use of personalized low-fat meal plans vs.     non-personalized low-fat meal plans and the results in body fat reduction in overweight and     obese subjects 25 to 45 years of age.      Compensation to Eligible Participants:        1. FREE Nutritional Services will be provided to eligible participants, which normally have          a business value of between $165.00 and $195.00.        2. Each eligible participant will receive compensation for mileage directly related to this          study up to 35 miles at the 2007 IRS Business Mileage Reimbursement Rate for medical          purposes of $0.20 per mile. This compensation will be provided to each eligible          participant in the form of a complimentary Wal-mart Gift Card in the amount of $7.00,          contingent upon his or her completion in the study.   "
201430|NCT00487357|"     Primary Objectives:        1. To collect data on health behaviors in the parents of MATCh study participants        2. To collect and/or update risk factor data from the parents of the MATCh study          participants.   "
201431|NCT00487370|"     The purpose of this study is to determine whether implanting gold beads extraarticularly in     five acupuncture-points around a knee improves pain, stiffness and function in patients with     knee osteoarthritis.   "
201432|NCT00487383|"     This study will examine the role of certain areas of the brain in blepharospasm, a type of     dystonia (abnormality of movement and muscle tone) that causes unwanted or uncontrollable     blinking or closing of the eyelids. The study will compare brain activity in healthy     volunteers and in people with blepharospasm to find differences in the brain that may lead to     better treatments for dystonia.      Healthy volunteers and people with blepharospasm who are 18 years of age and older may be     eligible for this study. All candidates are screened with a medical history. People with     blepharospasm also have a physical examination and blepharospasm rating.      Participants undergo transcranial magnetic stimulation (TMS) and electromyography (EMG) in     two 4-hour sessions, separated by 1 to 7 days.      TMS      A wire coil is held on the subject s scalp. A brief electrical current is passed through the     coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may     feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the     face, arm or leg. During the stimulation, subjects may be asked to tense certain muscles     slightly or perform other simple actions. Repetitive TMS involves repeated magnetic pulses     delivered in short bursts of impulses. Subjects receive 60 pulses per minute over 15 minutes.      EMG      Surface EMG is done during TMS to measure the electrical activity of muscles. For this test,     electrodes (small metal disks) are filled with a conductive gel and taped to the skin of the     face.   "
201433|NCT00487396|"     The aim of this study is to validate the ability of Capsule Endoscopy (CE) to accurately     diagnose small bowel (SB) Crohns disease in patients with symptoms of abdominal pain and     diarrhea.      The primary objective of the study is to evaluate whether Capsule Endoscopy prior to     colonoscopy will improve diagnosis in patients with suspected Crohns disease when compared to     standard diagnostic testing.   "
201434|NCT00487409|"     The purpose of this research is to compare two different standard of care surgical methods     for the following large bowel (colon) procedures: laparoscopic right colectomy, total     colectomy, and left colectomy. The study will compare electrocautery, used with surgical     clips and/or surgical staplers, and the Ligasure vessel sealer. The investigators will be     looking at which procedure is faster and more cost efficient and the investigators will     calculate hospital expenses for the two groups to make comparisons.   "
201435|NCT00487422|"     The purpose of this study is to determine whether prucalopride is safe and effective in the     treatment of chronic constipation in elderly patients.      Hypothesis:      Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the     treatment of patients with chronic constipation and is well tolerated in those patients   "
201610|NCT00479895|"     The test compound and subject of this clinical trial is the haemoglobin-based oxygen carrier,     HBOC-201 (Hemopure). HBOC-201, initially developed as an alternative to red blood cells for     surgical patients, has the ability to restore tissue oxygenation in persistently ischemic     tissue. The development of this new class of compounds, referred to as oxygen therapeutics,     provides an opportunity to test the safety and efficacy of a new approach to management of     myocardial ischemia.   "
201437|NCT00487448|"     Association group of therapeutic specialities authorized in a remission induction     treatment(FLAG-IDA: fludarabine, cytarabine, G-CSF (lenograstim) and idarubicin) and an     intensive postremission treatment with authorized therapeutic association specialities and     with/without Autologous Hemopoietic Stem Cell Transplantation or Bone Marrow Transplantation     in Patients With High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic     Leukemia.   "
201438|NCT00487461|"     The purpose of this study is to test whether treatment with a drug called Simvastatin     prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is     currently approved for the treatment of high cholesterol levels.   "
201439|NCT00487474|"     -  Measure the mid-facial volumetric correction from SCULPTRA treatment, using          three-dimensional digital surface imaging        -  Determine the mean change from baseline in facial contour deficiency as measured by the          Dermik Nasolabial Photo-numeric Scale        -  Correlate volumetric correction with clinical improvement as measured by the Dermik          Nasolabial Photo-numeric Scale        -  Correlate the mean volumetric change in mid-facial treatment area with the amount of          product used        -  Evaluate subject and investigator global assessment of improvement and subject treatment          satisfaction at the end of treatment        -  Obtain photographs pre- and post-treatment for the purpose of providing a subject visual          aid during the course of treatment        -  Collect safety data   "
201440|NCT00487487|"     Post-Poliomyelitis Syndrome (PPS) is the term describing the new problems affecting polio     survivors many years after recovery from paralytic polio. Among the symptoms, fatigue is one     of the most frequent and debilitating. In addition to physical incapacitation, the fatigue of     PPS also affects mental function. The term “brain fatigue” is usually used by patients to     express problems on the areas of attention, concentration, memory and clear thinking.     Unfortunately, little is known about cognitive fatigue of PPS patients. This study is meant     to examine if mental impairment is present in PPS patients and, if so, how it interferes on     the self-function of patients. Patients will undergo an interview, clinical and neurological     evaluation, and a battery of screening laboratory tests to make sure they are eligible for     the study. Patients who qualify will undergo neuropsychometric tests in order to assay     performance in the main areas of cognitive functioning. Through this organized approach we     expect to be able to determine if mental fatigue is a significant problem affecting polio     survivors, what areas are most affected, and how it may interfere with daily living.   "
201441|NCT00487500|"     This study will compare four types of electroconvulsive therapy to determine if they differ     in their effects on mood, thinking, brain activity, and biochemistry in people with major     depressive disorder.   "
201442|NCT00487513|"     In order to learn more about follicular lymphoma and anti-cancer vaccines, we are collecting     samples from people with this diagnosis. We then hope to make a vaccine from this tissue to     help the immune system destroy cancer cells. We plan on keeping samples in the tissue bank     indefinitely.   "
201443|NCT00487526|"     Study the effect of Duodenal jejunal bypass on human adults with type 2 diabetes.   "
201444|NCT00487539|"     The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148)     therapy in participants with ulcerative colitis (UC).   "
201445|NCT00487552|"     The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used     to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring     treatment of gastric outlet obstruction caused by malignancy.   "
201446|NCT00487565|"     Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior     stabilized design of the LCS® Complete Mobile-bearing Total Knee System   "
201447|NCT00487578|"     The purpose of this study is to determine whether naratriptan, a medication approved for     treatment of migraine, is effective in the treatment of post traumatic headache associated     with cognitive dysfunction.   "
201448|NCT00487591|"     The primary objective of this study is to compare the effect of simvastatin plus Omacor to     simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects     with mixed dyslipidemia.   "
201449|NCT00487604|"     The purpose of this study is to determine whether the use of drug eluting stents is     associated with higher rates of death, myocardial infarction, and major bleeding. In     addition, the overall economic costs of implanting drug eluting stents compared to bare metal     stents will be assessed.   "
201450|NCT00487617|"     To determine whether fruit juice might reverse endothelial dysfunction and whether this     reversibility has a prognosis value   "
201451|NCT00487630|"     Fabry disease (OMIM 301500) is an X-linked inborn error of sphingolipid metabolism resulting     from the deficiency of the lysosomal enzyme alpha-galactosidase A. Heterozygous females for     Fabry disease may be symptomatic with cardiac, renal or cerebrovascular involvement.     Clearance of Gb3 and stabilization of renal function has been demonstrated in male patients     treated with agalsidase beta (FABRAZYME). In contrast, no randomized, controlled study of the     efficacy of recombinant alpha-galactosidase A has been reported in heterozygotes for Fabry     disease.   "
201452|NCT00487643|"     Purpose: to build a library of normal tear lacritin values by collecting tears from normal     adult human subjects and to develop a non-invasive clinical assay for lacritin. Such an assay     will provide more sensitive indicators of eye disease for clinicians and determine if a     particular therapy, such as recombinant lacritin drops, is of benefit.   "
201453|NCT00487656|"     The purpose of this study is to see if ART-123 (recombinant human soluble thrombomodulin)     decreases the number of people who die as a result of Disseminated Intravascular Coagulation     (DIC) complication of sepsis.   "
201454|NCT00487669|"     This is a non-randomized, single-arm, single-institution, open label, two-stage phase II and     dose-ranging study designed to evaluate the efficacy and safety of paclitaxel poliglumex in     combination with pemetrexed in patients with advanced stage IIIB or stage IV NSCLC.   "
201742|NCT00481663|"     A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There     have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week     106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In     participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of     treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering     hemoglobin A1C (HbA1c).   "
201458|NCT00487721|"     Silibinin has demonstrated anti-cancer activity in the laboratory for several different     cancer types, including prostate cancer. Silibinin was originally obtained from milk thistle.     Silybin-Phytosome, an oral form of silibinin, has been tested previously in prostate cancer     patients to determine the safety of high-dose treatment. This study is for men with prostate     cancer who are planning to have their prostate surgically removed. Participants will be given     Silybin-Phytosome three times a day from enrollment in the study until the time of their     surgery. Participation in this study will not affect the timing of surgery. We obtain blood     and urine samples at the start and completion of the trial in addition to prostate tissue     from the surgery. These samples will be analyzed for the effect of Silybin-Phytosome at the     end of the study.   "
201459|NCT00487734|"     This study aims to determine whether testosterone replacement improves insulin sensitivity in     non-obese men with low testosterone and the metabolic syndrome. The metabolic syndrome     includes three of the following five conditions, 1) an elevated blood pressure (greater than     130/85), 2) a triglyceride level greater than 150 mg/dl, 3) an HDL-cholesterol less than 40     mg/dl, 4) glucose levels greater than 100 mg/dl, and 5) a waist measurement greater than 40     inches.   "
201460|NCT00487747|"     This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic     hepatitis B who are either treatment-naive, or who have failed lamivudine- or     interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c.     weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time     on study treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
201461|NCT00487760|"     This study will learn more about the beliefs of family members of African American patients     with lung cancer and whether these beliefs are associated with their interest in genetic     testing for disease risk and willingness to participate in genetics research. Lung cancer is     the second most common form of cancer and the leading cause of cancer deaths for men and     women in the United States. Like most cancers, there are racial and ethnic disparities (gaps)     in lung cancer cases and deaths. The age-adjusted rates for blacks and whites (years 2000 to     2003) was 76.9 per 100,000 and 66.0 per 100,000, respectively. Mortality rates were 62.5 per     100,000 for blacks and 55.3 per 100,000 for whites. Cigarette smoking is the most preventable     cause of lung cancer. Findings are that African Americans begin smoking at older ages and     smoke fewer cigarettes per day than Caucasian Americans do. Yet the severity of lung cancer     is greater for African Americans. Behavioral, social, environmental, and genetic factors may     explain the differences.      Participants (subjects) ages 18 to 55 who are family of patients with lung cancer who     self-identify as African Americans may be eligible for this study. Washington, D.C.,     researchers plan to recruit 115 lung cancer patients and 200 family members-100 current     smokers and 100 who never smoked. Lung cancer patients, who must have been born in the United     States, will be recruited from those who are receiving care at the Washington Cancer     Institute at the Washington Hospital Center. They will be asked to list relatives and friends     they consider to be as close as family. Patients will be asked permission for researchers to     contact those people. Family members will receive a letter telling them that unless they     decline to participate, they will be contacted by a telephone interviewer.      The survey will feature questions to evaluate family members' explanations for the causes of     lung cancer, as well as their reactions to possible reasons for the disparity in lung cancer     between African Americans and Caucasian Americans. Subjects will be asked about perceived     personal risk, worry about developing lung cancer, smoking history, motivation to quit     smoking, feelings about the lung cancer patient's diagnosis, racial identify, experience with     racial discrimination, pros and cons of genetic testing, and interest in genetic testing. The     survey will take up to 20 minutes to complete.      This study may or may not have a direct benefit for those who participate. However, lung     cancer patients and their families will be offered a free self-help guide to stop smoking.     They will be referred to local smoking cessation programs. Knowledge gained from the study     may be used to design smoking cessation methods and research studies related to genetics for     minority populations.   "
201462|NCT00487773|"     The purpose of the trial is to check if inhaled glucocorticosteroids (iGCS) have influence on     bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with     asthma.   "
201463|NCT00487786|"     This study is for patients with cancer who have failed potentially curative treatments or for     whose disease a curative treatment does not exist.      OGX-427 is an antisense product that inhibits expression of one of the heat shock proteins.     Decreasing this heat shock protein (Hsp27) should result in down regulation of pathways     implicated in cancer progression and development of resistance to treatment.   "
201464|NCT00487799|"     To determine the maximum tolerated dose (MTD) of ularitide in the treatment of subjects     hospitalized with symptomatic acute decompensated heart failure (ADHF).   "
201465|NCT00487812|"     Left myocardial infarction (MI), has a negative impact of long term morbidity and mortality.     Even in patients treated successfully by angioplasty in the acute phase of infarct, the     remodelling is observed in approximately 30% of cases. It is important to predict the     occurrence of this phenomenon in the early phase after MI for the selection of patients who     could eventually benefit from new therapeutic approach as for example cell replacement     therapy. It has been advocated that stem cells coronary injections should be performed     between the 5th and 10th day after an acute event. We hypothesise that a low dose dobutamine     gated Tc-99m-mibi SPECT performed on 5th-6th day after reperfused acute MI can predict left     ventricular remodelling and serve as a method to screen patients who could benefit from cell     replacement therapy.   "
201466|NCT00487825|"     This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and     oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)   "
201467|NCT00487838|"     This study will test a new method for preventing worsening of age-related macular     degeneration (AMD) and for developing imaging methods to follow the very earliest microscopic     changes in the disease. The macula is the part of the retina in the back of the eye that     determines central vision. AMD can impair central vision, affecting a person's ability to     read, drive, and carry out daily activities. Some studies suggest that cumulative exposure to     sunlight increases the risk for progression of AMD to the late stage that is often     characterized by poor central vision. This study will determine if wearing glasses with a     yellow filter over one eye and a red-violet filter over the other eye when outdoors will     decrease the rate of change of early-stage AMD in one or both eyes.      Patients early-stage AMD who have had cataract surgery in both eyes with implanted lenses may     be eligible for this study.      Participants undergo the following procedures:        -  Wear the filter glasses when outdoors between 10:00 a.m. and 4:00 p.m.        -  Record the time of day and light environment when they use the glasses.        -  Have an eye examination, pictures of the retina, and a medical history taken at the          beginning of the study and at set intervals during the study.      The study lasts at least 12 months and may be extended for a longer period of time....   "
201468|NCT00487851|"     Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery     in non-resectable periampullary cancer   "
201611|NCT00479908|"     The purpose of the study is to determine for how long sildenafil potentiates the blood     pressure reduction that occurs with glyceryl trinitrate in men with angina.   "
201469|NCT00487864|"     In vivo confocal laser scanning microscopy (CLSM) offers the possibility to non-invasively     investigate skin lesions at nearly histologic resolution. A recent study showed a high     sensitivity (97.6%) and specificity (88.15%) for the discrimination of clinical clear cut     melanocytic lesions. CSLM provides horizontal images and can be seen as missing link between     dermoscopy and histopathology. For a more accurate diagnosis of dermoscopically difficult to     diagnose melanocytic skin lesions in the grey zone between nevus and melanoma, the knowledge     of CLSM features of benign nevi seems to be essential. We investigated 30 flat benign nevi     with different dermoscopic patterns (10 reticular, 10 globular, 10 homogeneous) nevi. CLSM     images were assessed in terms of cytomorphologic and architectural criteria. Different     dermoscopic patterns of benign nevi are reflected in different architectural features in     CLSM.   "
201470|NCT00487877|"     To investigate the relationship between hungry-satiation situation including meal time and     metabolism, skin temerature changing, simpathetic & para-simpathetic response To investigate     the relashionship between hungry-satiation situation including meal time and heart rate   "
201471|NCT00487890|"     The purpose is to identify modifiable factors in older adults associated with functional     decline following major non-emergent surgery. The hypothesis of this proposal is that poor     preoperative exercise tolerance and physical performance, potentially modifiable factors, are     crucial in predicting functional decline and disability following surgery. When completed,     this study will reveal detailed information on the incidence and risk factors for functional     decline in older adults following surgery. It will direct future research targeting     interventions in older adults at highest risk for functional decline following surgery,     thereby decreasing the incidence of premature disability.   "
201472|NCT00487903|"     The purpose of this clinical trial is to evaluate various commercially available ultrasound     systems and to identify imaging parameters to be used with these systems (along with the     contrast agent PB127) as well as to further evaluate the safety of PB127.   "
201473|NCT00487916|"     This study will evaluate the safety and effectiveness of a vaccine called AMA1-C1/ISA.     Malaria is a serious infection of red blood cells caused by a parasite. There are 300 to 500     million malaria cases worldwide each year. About 2 to 3 million deaths annually are from     malaria alone or along with other diseases. Researchers hope to find a vaccine to fight     malaria.      Patients ages 18 to 45 who are in good health, are not pregnant or breast feeding, have no     history of malaria, and have not lived for more than 1 month in an area where malaria is     prevalent may be eligible for this study. There will be 28 participants, each assigned to one     of three dose groups: 12 get 5 microg, 12 get 20 microg, and 4 get 80 microg of AMA 1-C1     formulated in ISA 720. The vaccine might block the parasite from entering red blood cells and     causing disease. This study is the first time the vaccine will be given to human beings for     testing.      Patients will have a medical history, physical exam, laboratory tests, and pregnancy tests.     The study will last 48 weeks. One or two vaccinations are given by injection, at least 12     weeks apart. After each vaccination, patients will be asked to stay in the clinic for at     least 30 minutes for observation. They will return to the clinic on Days 1, 3, 7, 14, 28, and     56 after each vaccination. There will be a check of vital signs, brief physical exam, history     of symptoms and medications taken since the last visit, and blood tests to check for vaccine     safety and effectiveness. Photographs of the injection site on the arm may be taken. Patients     will receive a thermometer, diary card, and plastic measuring device. Each day they will     record their temperatures and any symptoms, and measure the size of any reactions at the     vaccination site. They will be asked to do this for 27 days after vaccinations.      After injections, there may be pain, swelling, and redness at the vaccination site, and     limitation of arm movement. General side effects from the vaccine may be fever, chills,     headache, fatigue, and muscle and joint pain. Patients will be asked if they agree to have     researchers keep any unused serum samples, for use only in research into malaria and other     diseases. Genetic testing would not be done on those samples. Stored samples will be labeled     with a code, and information is kept private.   "
201474|NCT00487929|"     The purpose of this study is to compare the levels of 8-isoprostane and other oxidative     stress biomarkers in plasma and condensed exhaled air between patients with SAHS and     cardiovascular complications, patients with SAHS without cardiovascular complications and     control subjects. To evaluate the effect of three months of treatment with CPAP on the     oxidative stress biomarkers.   "
201475|NCT00487942|"     The primary objective of this study is to evaluate if adjunctive armodafinil treatment can     improve the cognitive deficits in patients with schizophrenia   "
201476|NCT00487955|"     The purpose of our study is to evaluate the metabolic contribution of the human microbiota to     resting energy expenditure   "
201477|NCT00487968|"     Based on a need for a pediatric formulation of eltrombopag for the treatment of pediatric     thrombocytopenia, this study will help determine the best tasting pediatric formulation of     eltrombopag. Healthy adult volunteers who are able to taste bitterness and who do not have a     high sensitivity to bitterness will be enrolled. The subjects will evaluate different     formulations and rate them based on the bitterness and effectiveness of sweetners. The     outcome of this study will help support a decision for a new pediatric formulation of     eltrombopag.   "
201478|NCT00487981|"     The purpose of this study is to evaluate Spinal Cord Stimulation (SCS) therapy in individuals     who suffer from painful diabetic peripheral neuropathy. Patients invited to participate in     this study will be eligible for SCS therapy, and will have already selected therapy with the     Advanced Bionics Precision system independent of possible inclusion in this study. The     device, accessories, and procedures associated with device placement and the indications for     use are all consistent with the current and approved product labeling.   "
201479|NCT00487994|"     The purpose of this study is to evaluate the overall safety of Lapaquistat Acetate, once     daily (QD), by itself or in combination with atorvastatin in subjects with primary     dyslipidemia.   "
201480|NCT00488007|"     This is a 12-months' randomized clinical trial that aims at studying the benefit of bilateral     hearing aids in hearing impaired patients suffering from a slight to moderate stage Alzheimer     disease.      The benefit of this intervention will be studied in the cognitive, behavioural, quality of     life and economic fields.      2groups are involved in this trial: Intervention group: 12 months' treatment with active     hearing aids, fitted hearing impairment Control group: 6 months' treatment with placebo     hearing aids, followed with 6 months' active hearing aids, fitted hearing impairment   "
201481|NCT00488020|"     Collection of bone marrow blood Selection of mononuclear cells dilution with albumin     injection into the calf muscles through 40 shots   "
201620|NCT00480025|"     The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic     product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of     their tumor. A course of 13 injections will be administered over 27 months. The Protocol     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
201743|NCT00481676|"     This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to     severe chronic urticaria who exhibit IgE against thyroperoxidase.   "
201482|NCT00488033|"     Patients with a known history of diabetes mellitus and no prior documented evidence of     cardiovascular disease will be evaluated for inclusion in the study. Once qualified, patients     will be enrolled and be randomized to either the Control Arm or to the Asymptomatic Screening     Arm. Patients in the Control Arm will be followed by their primary care physicians with the     recommendation that they follow standard guidelines for management of diabetic patients.      Patients in the Asymptomatic Screening Arm will undergo CT screening for either coronary     calcium scoring or multi-slice CT angiography as well as be placed on one of two medical     regimens. Patients will be followed by telephone at six-month intervals for a minimum of one     year for both primary and secondary outcomes.   "
201483|NCT00488046|"     Over the past decade, avian influenza (AI) has become a major health concern. The development     of a safe and effective vaccine against H5N1 infection is important. The purpose of this     study is to determine the safety of a new AI vaccine in healthy adults.   "
201484|NCT00488059|"     This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in     an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1     infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of     the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily     until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator     phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day     or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were     terminated from the study. The anticipated time on study treatment was 3-9 months, and the     target sample size was 210 individuals.   "
201485|NCT00488072|"     Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to     placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An     improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on     the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days).      Secondary objective-A: To determine if Mirtazapine in comparison to placebo will improve     insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29     ( +/- 3 days)      Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve     other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and     anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as     measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients     with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days)      Other Objectives:      To provide exploratory data on the effects of Mirtazapine on weight gain, and     preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance),     on days 15 (+/-3 days), and 29 (+/-3 days).      To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on     decreased side effects of drug and increased appetite on day 29 (+/-3 days).   "
201486|NCT00488085|"     The aim of our study is to suggest possible underlying mechanisms for the observed clinical     differences in disease severity and behavior of overweight and obese patients with crohn's     disease(BMI > 25 kg/m²)as compare to non-obese crohn's patients with a normal or low weight (     BMI ≤ 25) by measuring metabolic\nutritional variables and cytokine levels.   "
201487|NCT00488098|"     The study is to show the new salt formulation of GSK372475 is equivalent to the old salt     formulation of GSK372475.   "
201488|NCT00488111|"     Cesarean section-associated hypotension is one of the pivotal factors to influence the Apgar     Score of children and related with the stable hemostasis during the whole process of labor.     How to keep circulation in a consistent stability is yet to be known. The investigators     hypothesized that different fluids, crystalloids or colloids, can produced varying effects in     keeping the physiological environment of labor from significant fluctuating.   "
201489|NCT00488124|"     Growth hormone therapy will improve the height of short statured children with pathological     conditions that lead to growth retardation. Growth hormone therapy will show an increase in     height velocity >1 SD compared to pretreatment height velocity. and the therapy will be safe.   "
201490|NCT00488137|"     The purpose of this study is to determine whether prucalopride is safe and effective in the     treatment of chronic constipation.      Hypothesis:      Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the     treatment of patients with chronic constipation and is well tolerated in those patients   "
201491|NCT00488163|"     Relationships between altered prefrontal cortical dopamine, norepinephrine and some cognitive     impairments of schizophrenia supports and approach for pharmacological remediation of     cognitive symptoms through manipulations of prefrontal cortical dopamine and norepinephrine.     Atomoxetine, a selective norepinephrine re-uptake inhibitor, produces a widespread increase     in brain norepinephrine and a secondary and selective increase in prefrontal dopamine. Given     this, we are evaluating atomoxetine’s cognitive effects in a pilot placebo controlled trial     in patients with schizophrenia. Moreover, an fMRI investigation was undertaken to assess the     neural mechanisms underlying the cognitive effects of atomoxetine.   "
201492|NCT00488176|"     The aim of this study is to compare the effect of montelukast and cetirizine on allergic     inflammation measured by exhaled nitric oxide concentration in children with seasonal     allergic rhinitis.   "
201493|NCT00488189|"     This is an antibiotic intervention study to determine the value of using     piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae     colonization and infection.   "
201494|NCT00488202|"     Women with Advanced Ovarian Cancer (AOC) suffer from severe sexual side effects from     treatment. The prevalence of the sexual issues is not known.      The degree to which these sexual side effects is affected by treatment is also not known, as     the literature in this area focuses on post-treatment analysis.      Specific Aim #1 (Quantitative Phase): To determine the prevalence and types of sexual     difficulties using self-report questionnaires in women about to receive treatment for Stage     III or IV Ovarian Cancer at the BCCA and over time, and to correlate these symptoms with     degree of cancer symptoms, well-being, depressive symptoms, and relationship satisfaction   "
201495|NCT00488215|"     An escalating dose of prucalopride up to a maximum of 20 mg was given once daily to 32     healthy volunteers to determine safety at the maximum tolerable dose or at 20 mg.   "
201498|NCT00488254|"     Long QT Syndrome (LQTS) is a disease of young adults and can affect women of child bearing     age. Suffers of LQTS are at risk of ventricular dysrhythmias including torsades de pointes     and ventricular fibrillation.      Pregnancy increases the chance that any mother may have an abnormal heart rhythm or     arrhythmia. This chance is higher with the LQTS. There are only a few reported cases of women     with the LQTS having a baby in the medical literature. This can make it difficult for the     doctor caring for a pregnant woman with the long QT syndrome - especially should they need an     anesthetic.      We would like to study as many women who have had a baby who have the long QT syndrome to     give us a better idea of whether there are any arrhythmias occurring at the time of delivery.   "
201499|NCT00488267|"     ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD     (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated     with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to     moderate pain associated with osteoarthritis of the knee in adults.   "
201500|NCT00488280|"     The Kids STEP Study aims to        1. Determine if walking can be restored in children with incomplete SCI and little to no          leg movement        2. Identify the neural pathways that permit recovery of walking   "
201501|NCT00488293|"     This study compares store and forward teledermatology with the conventional clinic-based     consult process. Our primary objective is to determine whether the mean change in quality of     life, as rated by the subscale scores and composite score on the Skindex-16 differs between     the store and forward and conventional care modalities.   "
201502|NCT00488306|"     In light of tigecycline's activity against these resistant bacteria, tigecycline may     represent a viable new therapy for complicated intra-abdominal infections.   "
201503|NCT00488319|"     The purpose of this open-label study is to evaluate the long-term (6-month) safety and     tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible     dosages to adolescents with schizophrenia.   "
201504|NCT00488332|"     Objectives:        1. To assess the tolerability of performing optical coherence tomography and/or optical          spectroscopy in patients with acute oral mucositis.        2. To determine the feasibility of obtaining optical coherence tomography images and/or          fluorescence excitation emission matrices from normal and affected sites in patients          with acute oral mucositis.        3. To compare optical data obtained with optical coherence tomography and/or spectroscopy          with the clinical appearance and scoring of oral mucositis lesions.   "
201505|NCT00488345|"     To determine the pharmacokinetic profile and to evaluate the safety and tolerability of     ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious     infections; complicated intra-abdominal infections (cIAI), complicated skin and skin     structure infections (cSSSI), or community-acquired pneumonia (CAP).   "
201506|NCT00488358|"     To compare the aortic pulse profile before and after stent-graft implantation to prove that     endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile.   "
201507|NCT00488371|"     Primary Objective:      To evaluate the impact of PCV7 vaccination on NP carriage rate of vaccine serotypes and     serotype distribution      Secondary Objective:      To evaluate the impact of PCV7 vaccination on NP carriage of antibiotic resistant pneumococci     and serotype distribution.   "
201508|NCT00488384|"     Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous     cell carcinoma of the skin in increasing doses up to 25 mg daily for one year.   "
201509|NCT00488397|"     In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.   "
201510|NCT00488410|"     Patients showing a normal value of SDI (< or + 8%) will randomly be assigned to CRT in ON     or OFFmode at one month after implantation. In any case of emergency, an automated rescue     mode is included in the device for the patients in OFF mode.   "
201511|NCT00488423|"     MIDAS involves an assessment of glucose levels obtained before and after bariatric surgery.     There are two different procedural tests involved; an oral glucose tolerance test (mixed     meal) and a hyperglycemic clamp test. Two tests are performed preoperatively and five more     are performed postoperatively for a one year period. The associated labwork drawn with the     mixed meal and clamp tests are demonstrating changes in glucose, insulin and gut hormone     levels.   "
201512|NCT00488436|"     The different mechanisms of action between Antithymocyte globulin and cyclosporine can     improve the effectivity when both are used in combination in patients with myelodysplastic     syndrome.   "
201513|NCT00488449|"     The purpose of this study is to compare the effects of single and repeat doses of GSK256073     with placebo in HVT subjects.   "
201514|NCT00488462|"     This trial will address the question of whether early application of the Non-pneumatic     Anti-Shock Garment (NASG) at the Satellite Health Facility (SHF) level before transport to a     Referral Hospital (RH) will decrease maternal mortality and morbidity. The available evidence     indicates that the NASG substantially decreases blood loss, but there is no evidence that its     application will reduce extreme adverse outcomes. It is also not known if possible side     effects associated with NASG use might outweigh potential benefits. This study would     rigorously test the effectiveness of the NASG using an experimental design with adequate     power to detect statistically significant decreases in morbidity and mortality.   "
201535|NCT00488735|"     BACKGROUND      Non-specific back and neck pain (BNP) dominates sick-listing. A program of     cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month     follow-up, with traditional primary care concerning sick-listing and health-care visits.      METHODS      After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (=     full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were     randomized to a rehabilitation center or continued health-center care. Outcome measures were     Return-to-work (=the proportion who regained work ability for at least 30 consecutive days),     the proportion with Work ability at different time points, Total sick-listing (expressed in     whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months     and corresponding six-month periods. For the analyses were used t-test, z-test, generalized     estimating equations and a mixed, linear model.   "
202126|NCT00486707|"     The objective of this study is to evaluate the willingness of patients with ovarian cancer to     undergo genetic testing, given the cost, their understanding and acceptance of genetic     testing and the possibility of targeted therapy.   "
201515|NCT00488475|"     The diagnosis, evaluation and treatment of rheumatoid arthritis (RA) continue to undergo     rapid change. Randomized controlled trials such as the TEMPO study have demonstrated the     efficacy and safety of the combination of etanercept and methotrexate. Importantly, the TEMPO     study showed that patients treated with etanercept and methotrexate could reach the newer     therapeutic goals of low disease activity and remission, and that the physicians, patients,     and payers are no longer prepared to accept the goal of Reduction of symptoms. RCT are     important and powerful tools in assessing efficacy and safety but have their limitations in     terms of generalisability. In order to assess health economics, clinical effectiveness and     safety of etanercept, they need to be measured by performing observational studies of     unselected patients. This study aims to provide a holistic assessment of patients receiving     etanercept in a real world setting. This will include centers that would not normally take     part in RCT. The study will assess treatment with etanercept with descriptive statistics of     the following parameters: Health economic, Safety, Effectiveness. In addition, there was a     previous study of similar design, but of only 3 months duration (101354), which will allow     comparison with historical data. Since previous study, there have been a number of     significant changes: Introduction of a new formulation for etanercept (Enbrel® 50mg · once     weekly), Definition of early RA has been modified to short disease duration (from 3 months to     1 year).   "
201516|NCT00488488|"     To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main     goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to     assess the main side effects observed in daily medical practice (Safety of Tygacil); to     determine whether patients are optimally dosed with Tygacil (according to the label) and the     proportion of patients receiving a monotherapy versus combination therapy; to observe the     potential resistance development against Tygacil in Germany; to determine which antibiotic     agents are chosen for a combination therapy with Tygacil; to determine to which antibiotic     substance non-responders to Tygacil are switched; to assess the duration of the intravenous     therapy with Tygacil and to determine whether and which patients receive an oral antibiotic     substance after the therapy with Tygacil; to collect information on profile, comorbidities     and characteristics of patients treated with Tygacil.   "
201517|NCT00488501|"     In this study we investigate the clinical value and efficacy of OptiVol (TM) impedance     measurements by Medtronic (R) ICD's. We aim to determine sensitivity and positive predictive     value for detecting heart failure. We also investigate if left ventricular filling pattern     measured by echocardiography and/or brain natriuretic peptide (BNP) level can be used to     improve the positive predictive value of the Optivol alert   "
201518|NCT00488514|"     This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen     sodium) in adolescents for the acute treatment of migraine.   "
201519|NCT00488527|"     To evaluate the efficiency of Lantus plus combined oral hypoglycaemic agents in terms of     respondents percentage. The respondent is defined as the person achieving a value in the     final determination of HbA1c < 7% as its absolute value and/or a decreasing in the final     value of HbA1c of more than 12% compared with the initial value (final HbA1c vs. initial     HbA1c).      Describe the glycemia levels and body weight change in the two response groups, (respondents     and non-respondents).      Describe the adverse events Evaluate the safety of using the medication according to the     incidence and relevance of the hypoglycemia events, (symptomatic, diurnal, nocturnal,     severe).      Estimate the intra-patient variability of the fasting glycemia   "
201520|NCT00488540|"     There are many reasons for using a vacuum apparatus or forceps to assist in delivering a     baby. The traction and pressure on the baby`s head due to the vacuum apparatus or forceps may     cause pain and discomfort for some time after the delivery. To date, the pain experienced by     the newborn and the potential beneficial effects of pain medications after vacuum or forceps     deliveries have not been systematically studied. It is possible that administration of     paracetamol suppositories to the newborn may be helpful in these situations, since this     medication is known to ameliorate pain in older children and adults.   "
201521|NCT00488553|"     Primary Objectives:        1. To enroll and obtain, through questionnaires, risk factor information on all study          participants to develop detailed demographic, epidemiologic and behavioral profiles.        2. To assess the influence of relevant epidemiologic covariates such as age, gender,          smoking and family history of cancer on the panel of susceptibility biomarkers.        3. To evaluate the role of genomic instability in development of lymphomas.   "
201522|NCT00488566|"     This is a First Time in Human Study to assess the safety, tolerability, pharmacokinetics and     resting motor threshold (rMT) of single doses of GSK drug in healthy volunteers.This will be     a 2 part and 2 centre study.Part 1 will be a double-blind, randomized, placebo-controlled,     single oral dose, dose-rising, cross-over study in healthy male and female (of non-child     bearing potential) volunteers.Subjects will be randomized into cohorts of 10 subjects and     cohorts will be recruited until the pre-defined safety or PK stopping limits are reached.Each     subject will receive placebo and no more than 4 ascending doses of GSK drug in a randomized     sequence on 5 separate study occasions.Each dosing session will take place over 2 days and     there will be at least one subject on placebo on each day. There will be only one subject on     any new active dose during the first day.Part 2 will be a randomised, double-blind,     double-dummy, placebo-controlled, cross-over study to investigate the effect of single doses     of GSK drug and lamotrigine on resting motor threshold in healthy male subjects. Subjects     will attend the unit a maximum of 4 separate occasions.During each session subjects will     receive up to 4 TMS measurements and single doses of either GSK drug, lamotrigine or placebo,     in a randomised manner.Up to two doses of GSK drug will be investigated.   "
201523|NCT00488579|"     Comparison of two policies of iron administration during pregnancy in regard to health and     program feasibility in an area with endemic malaria and high prevalence of HIV infection. The     policies are: 1) routine iron prophylaxis, 2) screening and therapy with iron.   "
201621|NCT00480038|"     The main purpose of this study is to determine the measurement characteristics of WHODAS II     (World Health Organization Disability Assessment Schedule), as well as to analyze its     correlation with symptomatic lumbar disc herniation (Visual Analog Scale, VAS), disability     (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and     attitudes (Spanish version of the FAB Questionnaire, FABQ) and quality of life (SF-12).     Measurements will be taken at baseline and 6 days later (day 7).   "
201524|NCT00488592|"     This study will test the safety and effectiveness of two vaccines on slowing disease     progression, improving blood counts, reducing the need for transfusions of blood and     platelets, or achieving remission in patients with myelodysplastic syndrome (MDS, also known     as myelodysplasia), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). The     vaccines consist of peptides (parts of proteins) found in MDS, AML and CML stem cells,     combined with a substance called MontanideTM. They are administered with granulocyte-     macrophage colony- stimulating factor (GM-CSF). The Montanide and the GM-CSF help the immune     system respond to the vaccines.      People 18 years of age or older with MDS, AML or CML may be eligible for this study.      Participants receive six injections of the vaccines, one dose every other week for a total of     10 weeks. The injections are given in the upper arm, upper leg, or abdomen. A separate     injection of GM-CSF is given in the same area as the vaccine injections. Subjects are     observed for 2 hours after the first vaccination and at least 30 minutes after each     subsequent vaccination for allergic reactions. In addition to the vaccination, subjects     undergo the following:        -  History and physical exam, chest x-ray, blood tests and bone marrow aspirate and biopsy          before starting the vaccinations.        -  Safety monitoring during vaccine administration (every other week for 10 weeks) with          blood tests and check of vital signs.        -  Follow-up safety monitoring (weeks 12 and 16) with blood tests every visit, chest x-ray          at week 12 and bone marrow biopsy visit 16.   "
201525|NCT00488605|"     LCH III is an international, multicentric, prospective clinical study comprised of:        -  a randomized clinical trial for multisystem RISK patients and        -  a randomized clinical trial for multisystem LOW RISK patients and        -  a pilot study for patients with single system MFB and localized SPECIAL SITES   "
201526|NCT00488618|"     This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188     monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks     double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility     criteria will be randomized to one of two treatment groups: RGH-188 or placebo   "
201527|NCT00488631|"     The purpose of this study is to assess the safety and efficacy of golimumab administered     subcutaneously (under the skin) injections in maintenance therapy.   "
201528|NCT00488644|"     Primary Objectives:        1. Assess whether combined treatment with Levothyroxine and Liothyronine improves learning          and memory.        2. Explore the relationship between T3 treatment and other domains of cognitive function,          quality of life, and mood.   "
201529|NCT00488657|"     This project will systematically examine the therapeutic effect of altered auditory feedback     provided by the in-the-ear device on the speech impairments in patients with Parkinson's     disease.      Many patients with PD have difficulty starting their speech even though they know the words     they want to say. They experience 'freezing' of the jaw, tongue and lips. When they     eventually get their speech started, they have a hard time moving it forward. They keep on     saying the same words or phrases over and over again while their voice gets softer and     softer. Many words also run together. These symptoms make patients' speech very hard to     understand and directly affect their care and quality of life. Currently, there is no     effective medical or surgical treatment for these speech symptoms.      We have tested an in-the-ear therapeutic device that provides altered auditory feedback in     eight patients with PD and moderate to severe speech impairment and the results are     encouraging. We will recruit 100 patients with PD and moderate to severe speech impairment     for Phase A and 20 for Phase B of the study. They will use the device routinely to provide     the altered auditory feedback as they speak to improve their speech intelligibility.   "
201530|NCT00488670|"     To investigate the effect of Escitalopram in a large and diverse of dementia patients     suffering from depression.   "
201531|NCT00488683|"     This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135     and Y specific memory B Cells, measured 1 month after a primary vaccination series of     Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human     complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age   "
201532|NCT00488696|"     This is a study to assess the safety and effectiveness of endovascular treatment of aortic     aneurysms involving the proximal aortic arch. The investigational operation involves placing     a stent-graft over the aortic aneurysm.   "
201533|NCT00488709|"     The study is designed with drugs used frequently in the treatment of AML, but with a new     combination less toxic,and effective in AML multidrug resistant.      Justification:        -  The AML patients with primary resistance or relapsed in the first 12 months after CR,          have second line chemotherapy low response rate .        -  These patients with AML with primary resistance or relapse, that reach remission after a          rescue treatment, have an interval free survival and a global survival very short        -  Probably the resistance to the treatments is in relation to different forms expression          of the MDR.        -  Complete remission is considered valid evaluation, because every patient who should          obtain a CR can be considered to be eligible for a possible curative treatment: Ara-C          administration to high doses or the TPH treatment   "
201534|NCT00488722|"     It has been found that many breast cancers are hormone dependent and that hormonal therapy by     estrogen suppression such as ovarian ablation, tamoxifen and aromatase inhibitor has proven     beneficial in both adjuvant and neoadjuvant settings. Zoladex, a kind of luitinizing hormone     releasing hormone analogue, can offer efficient estrogen suppression as well. It can induce     reversible amenorrhea and the clinical effect is similar to ovarian ablation. Some studies     have demonstrated the efficacy of zoladex in treating pre and perimenopausal hormone     dependent breast cancer in both adjuvant and metastatic settings. Few data is available on     Zoladex in neoadjuvant treatment for breast cancer In our departments, neoadjuvant CEF     regimen is of general practice, and a preliminary study is designed to investigate whether     adding Zoladex into neoadjuvant CEF could further improve results in hormone responsive     breast cancer.   "
201638|NCT00480259|"     This study is designed to determine if the following are true. When protein requirements     exceed metabolic requirements, blood urea nitrogen(BUN) levels will rise. Elevated BUN levels     in the absence of renal failure, hepatic failure, or GI bleeding, will be correlated with     improved nitrogen balance and inversely correlated with infection rates, days of mechanical     ventilation, ICU days, and total hospital days.   "
201536|NCT00488748|"     This study will compare the clinical efficacy and side effects of Magnetic Seizure Therapy     (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major     depressive episode in the context of either unipolar or bipolar depression. The investigators     will conduct a number of clinical and neuropsychological tests to assess clinical and     cognitive response to treatment. The investigators hypothesize that:        1. MST and ECT will have similar antidepressant efficacy.        2. MST will have less post-treatment amnesia than ECT as reflected in primary measures of          anterograde and retrograde amnesia following the acute treatment phase.        3. At follow up, MST will show a lesser degree of persisting deficit in measures of          retrograde amnesia than ECT.   "
201537|NCT00488761|"     Tigecycline's activity against resistant organisms, as well as significant coverage of both     gram-positive and gram-negative bacteria, may provide a valuable therapeutic alternative in     treating patients with complicated skin and/or skin structure infections.   "
201538|NCT00488774|"     The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148)     therapy in participants with active ulcerative colitis (UC) (sores in the colon).   "
201539|NCT00488787|"     Once patients' postoperative pain intensity reaches a moderate-to-severe level, they are     randomized to receive intranasal ketamine or placebo. Patients remain in the study unit for 3     hours post administration and assess pain intensity and pain relief throughout the 3 hour     postoperative period.   "
201540|NCT00488800|"     This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian     children.      Prevenar is indicated for active immunization of infants and children from 6 weeks of age     through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia,     bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and     23F.      Prevenar has been marketed in India since June 2006. The Board of Health in India has given     restricted permission to import and market Prevenar. The present study is a post-approval     regulatory commitment to the Board of Health in India.      This is an observational study and the protocol for the study has been approved by the Board     of Health.   "
201541|NCT00488813|"     A single-center, prospective, comparative, antibiotic intervention study for patients     admitted to MICU1 and MICU2   "
201542|NCT00488826|"     This study is a combination of a Phase I and Phase III study design. The Phase I portion is     an open-label, controlled study to evaluate the safety of 7vPnC in healthy Chinese infants.     The Phase III portion is an open-label, controlled, randomized study to evaluate the safety     and immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)in healthy Chinese     infants. Both phases include a Primary Series which includes the primary 3 doses of 7vPnC and     /or Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP) at about 3, 4, and 5     months of age; and a Booster Dose which includes the 4th dose of 7vPnC at 12-15 months of     age.   "
201543|NCT00488839|"     The purpose of this study is to determine the effects, both good and bad, of IPX056 on     subjects and their spasticity. This study will also determine the relationship between the     amount of IPX056 in blood and the effects on spasticity. Lastly, this study will determine     how long IPX056 affects spasticity.   "
201544|NCT00488865|"     This study is designed to evaluate the safety and efficacy of the RexMedical Option* Vena     Cava Filter in the treatment of patients who are at increased risk for Pulmonary Embolism and     require caval interruption.   "
201545|NCT00488878|"     The goal of this psychosocial research study is to collect information on patients with one     of the above-mentioned low-grade tumors. Researchers want to maintain these patients'     information in a research database to help learn and better understand these tumor types and     to help develop better treatments for them.      This is an investigational study. There will be no cost for participating in this research     study. Up to 2000 patients from MD Anderson will take part in this study.   "
201546|NCT00488891|"     The purpose of this study is to examine the long-term economic, functional and clinical     outcomes in schizophrenia patients who require a change in antipsychotic treatment, and are     changed to either paliperidone extended release (ER) or another oral atypical antipsychotic     agent (AAP) including aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone.   "
201547|NCT00488904|"     To discover whether an Omega-3 fatty acid (eicosapentaenoic acid/EPA and     docosahexaensyre/DHA) enriched nutritional supplement given 7 days preoperatively and 7 days     postoperatively may reduce the frequency of postoperative infectious complications defined     as: pneumonia, wound infection, urinary tract infection, peritonitis (including anastomotic     leakage) and septic conditions of any cause in patients who undergo elective operations for     colorectal cancer compared with a nutritional preparation that is identical apart from the     EPA content.   "
201548|NCT00488917|"     The purpose of the study is to determine the role of new biomarkers in the diagnosis of     sepsis in critically-ill patients with liver failure and to correlate the prognosis of these     patients with parameters of endothelial function and lipid metabolism.   "
201549|NCT00488930|"     A research study to find out more about a specific white blood cell called a dendritic cell.     These cells are found in a layer of fat in the body called the omentum. The omentum is a     layer of fat that covers the bowels (intestines) and protects them.      The purpose of this study is to allow us to compare dendritic cells in normal weight     individuals to the dendritic cells of people who are extremely overweight. These cells will     be collected from the omentum, the layer of fat that covers and protects the bowels     (intestines), from the mesentery, which is another layer of fat that surrounds the intestines     directly, and from the subcutaneous tissue, which is the layer of fat just under the skin.   "
201550|NCT00488943|"     To collect and analyze clinical follow-up data which can be used to assess the safety,     efficacy, and durability of endovascular AAA repair with Zenith and Chuter-Gianturco     stent-grafts.   "
201591|NCT00489489|"     The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide     administered once daily for 24 weeks, compared with placebo, in patients with multiple     sclerosis [MS] with relapses who were on a stable dose of interferon-β [IFN-β].      Secondary objectives were:        -  to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in          combination with a stable dose of IFN-β on Magnetic Resonance Imaging [MRI] parameters,          relapse rate and patient-reported fatigue;        -  to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with          a stable dose of IFN-β.   "
201551|NCT00488956|"     Some women develop swollen feet and ankles after a cesarean delivery. These women will often     complain that their shoes are too tight and their feet may become numb or they may have some     tingling in their feet.      Currently we do not know for sure that foot swelling occurs after a cesarean delivery and if     it does what the cause is.      If we find that feet do swell after a cesarean delivery we may be able to suggest a cause.     This may in the future prevent women developing excessive foot swelling.      We aim to investigate whether the size and shape of women's ankles do change following an     elective cesarean delivery. We plan to investigate, if possible, the cause of any foot     swelling after a cesarean whether it be the volume of intra venous fluids or oxytocin use.   "
201552|NCT00488969|"     We would like to learn if a medicine called modified-release morphine sulfate (Avinza)     helps reduce Spinal Cord Injury (SCI)-related pain that has lasted a long time.     Modified-release means that the medicine in the capsules is slowly released to the body,     instead of being released all at once. Avinza is approved by the Food and Drug Administration     for the treatment of pain, but we do not know how effective Avinza is in reducing SCI-related     pain.   "
201553|NCT00488982|"     This is a two-arm, randomized Phase II study of intermittent chemotherapy with and without     GM-CSF. All patients will receive six 21-day cycles of docetaxel 75 mg/m2 on Day 2 of each     cycle and 5 mg prednisone twice a day on Days 1-21. Following six cycles of chemotherapy,     eligible subjects will be randomized to no maintenance therapy or to maintenance GM-CSF     therapy. The GM-CSF group dose schedule will be 250 mcg/m2 SQ daily Days 15-28 every 28 days.     Patients in both groups will continue until disease progression at which time GM-CSF will be     discontinued and chemotherapy will again be administered.   "
201554|NCT00488995|"     The purpose of this study is to determine if CP-675,206, a monoclonal antibody to CTLA4, is     safe and well-tolerated, reduces viral load, and improves immune function in patients     infected with HIV.   "
201555|NCT00489008|"     The goal of this clinical research study is to learn if stereotactic body radiotherapy (SBRT)     can help to control NSCLC. The safety of SBRT will also be studied.      Objectives:      To assess therapeutic efficacy and toxicities of stereotactic body radiotherapy (SBRT) for     patients with medically inoperable stage I (T1-2, N0,M0), selective stage II (chest wall T3,     N0M0) or isolated peripheral lung recurrent non-small cell lung cancer (NSCLC).      Primary goal: Improve 2 years progression free survival at the treated primary tumor site.      Secondary goals:        1. Improve disease free survival, disease specific survival and overall survival at 2          years.        2. Decrease grade 3 and above acute and/or chronic toxicities.        3. Collect blood for future biomarkers study   "
201556|NCT00489021|"     Hospitalization is a traumatic event for the patient and his family at any age nevertheless     in the older age. One of its consequences is the difficulty to resume previous activity of     daily living especially in older (over 75 years) patients. Sub acute completes the acute     phase of the hospitalization and its main purpose is to improve the patient's functional     status and quality of life. There are not enough clinical trails to proof this assumption.     The purpose of our study is to compare the outcome of acute and sub-acute hospitalization     programs by a randomized controlled prospective intervention study. Outcome measures will     comprise activity of daily living, functional status, re-hospitalization and utilization of     medical services following the hospitalization.Study hypothesis is that sub-acute     hospitalization will improve outcomes and will cost less.   "
201557|NCT00489034|"     The proposed multi-site, longitudinal study will examine the correlation of substance use,     mental health disorders, and social networks to engagement in care for HIV-infected     adolescent females, aged 13 years, 0 months - 23 years, 11 months, and suggest ways to     promote adherence and retention in treatment, care, and prevention programs. Qualitative and     quantitative data collection methods will be used with index participants and network     members.   "
201558|NCT00489060|"     A trial to determine if cryoablation is as effective as radiation in the treatment of men     with localized prostate cancer.   "
201559|NCT00489073|"     The primary purpose of this study is to determine if duloxetine reduces pain severity in     patients with fibromyalgia.   "
201560|NCT00489086|"     RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying topical tazarotene to see how well it works in     treating patients with basal cell skin cancer and basal cell nevus syndrome on the face.   "
201561|NCT00489099|"     A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B     vaccine manufactured using an upgrade to the production process. The primary hypotheses     tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the     process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen     (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection     to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to     HBsAg that are non-inferior or superior to those induced by the current process vaccine.   "
201562|NCT00489112|"     We will performe a prospective randomized study to evaluate the effects of the addition of     alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. A     total of 60 patients with distal ureteral calculi will randomly divide into two treatment     groups: group A (n=30) who will receive only analgetic therapy(Dipyrone)and diclofenac i.m.     75mg and group B (n=30) who will receive the same therapy plus alfuzocin xl (10 mg/daily) for     a maximum of 2 weeks.No significant differences will be between the groups for age, gender     distribution and mean stone size measured in the single largest dimension at     presentation.Randomization will be done only with the patients permission after they had read     a summary describing the goals of conservative management and a description of the drugs they     would be taking. Potential side effects and complications of the drugs were discussed. The     expulsion rate will the primary end-point of this study.   "
201563|NCT00489125|"     RATIONALE: Gathering information about strength and range of motion over time from women     undergoing surgery for breast cancer may help doctors learn more about recovery from surgery     and on-going care.      PURPOSE: This clinical trial is collecting information about strength and range of motion     over time from women undergoing surgery for breast cancer.   "
201606|NCT00479830|"     The goal of this research study is to learn about the health practices, health knowledge, and     attitudes of South Asian Americans who live in Houston or the surrounding area.   "
201564|NCT00489138|"     Goal of study:      To assess the tissular and plasma kinetics of ertapenem;      To determine the optimal dosages in the patients according to norepinephrine administration:        -  to assess muscular diffusion of free form of ertapenem after administration to          mechanically ventilated patients requiring such a treatment. The patients are included          in the groups with norepinephrine or without norepinephrine according to their          hemodynamic status.        -  to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients          treated or not by norepinephrine.      Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700     beds).   "
201565|NCT00489151|"     Liver diseases due to hepatitis B reactivation are serious causes of morbidity and mortality     in hepatitis B infected patients treated with chemotherapy. We have previously shown that     with pre-emptive use of lamivudine, one can drastically reduce liver-related morbidity and     mortality in such patients. However, due to the development of hepatitis B virus resistance     to lamivudine, some of these hepatitis B infected patients still develop hepatitis. This is a     research study aiming to compare the use of adefovir dipivoxil to lamivudine in hepatitis B     infected patients treated with chemotherapy. Both of these drugs have been approved for the     treatment of the hepatitis B infection in the United States, European Union and Hong Kong.      All patients who were recruited in this study will receive study medication, either     lamivudine 100 mg daily or adefovir dipivoxil 10 mg daily to cover the entire period of     chemotherapy for 72 weeks. All patients will be follow-up for an additional 24 weeks     thereafter. Altogether, 70 subjects will be recruited from Queen Mary Hospital, Hong Kong     SAR.      This is an open-label study, which means that the patients and the study doctor will know     which treatment the subjects are assigned into. If a subject decides to take part in the     study and is found eligible, he/she will be randomly (like flipping of coin) assigned to one     of the following dose groups:      Lamivudine (100 mg) tablet Adefovir dipivoxil (10 mg) tablet   "
201566|NCT00489164|"     The main objective of this study is to assess in-stent late lumen loss in diabetic patients     with de novo native coronary lesions using the sirolimus-eluting Bx VELOCITYä stent as     compared to the Bx VELOCITY balloon-expandable stent.   "
201567|NCT00489177|"     This international study is assessing if repeat adjustment of the timing between the three     leads in a cardiac resynchronization therapy (CRT) defibrillator will increase the likelihood     of benefit (symptoms and heart function) compared to usual device programming. The hypothesis     is that QuickOpt facilitated serial optimization of sensed atrioventricular (sAV), paced     atrioventricular (pAV), and inter-ventricular (VV) timing in the initial 9 months following     successful CRT will increase the rate of clinical response and structural remodeling at 12     months compared to usual care.   "
201568|NCT00489190|"     To collect effectiveness and safety data during the treatment with Apidra glulisine (HMR1964)     by means of subcutaneous injections to patients with Diabetes Mellitus 1st type during 12     weeks-active phase.   "
201569|NCT00489203|"     RATIONALE: Beclomethasone dipropionate may be effective in preventing acute graft-versus-host     disease in patients undergoing a stem cell transplant for hematologic cancer.      PURPOSE: This randomized phase II trial is studying how well beclomethasone dipropionate     works in preventing acute graft-versus-host disease in patients undergoing a donor stem cell     transplant for hematologic cancer.   "
201570|NCT00489216|"     RATIONALE: Efalizumab may be an effective treatment for graft-versus-host disease of the skin     caused by a donor stem cell transplant.      PURPOSE: This clinical trial is studying the side effects and how well efalizumab works in     treating patients with graft-versus-host disease of the skin that did not respond to previous     steroids.   "
201571|NCT00489229|"     The aim is to examine whether pharmacological interventions with thiazolidinedione and     angiotensin converting enzyme (ACE) inhibitors can reverse pre-clinical vasculopathy in newly     diagnosed diabetic and IGT individuals.   "
201572|NCT00489242|"     Aims of this study will be to assess the difference in CFV/CFR (Coronary flow     velocity/reserve) in diabetic vs. non-diabetic patients and to correlate CK-MB, TnI and HsCRP     release after otherwise successful coronary stenting.   "
201573|NCT00489255|"     The purposes of the study are to determine:      i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting     when initiating therapy with Apokyn® (apomorphine)      ii. To determine the optimal duration for continuation of Tigan® following initiation of     Apokyn® therapy      iii. To assess the safety of Tigan® in combination with Apokyn®      iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated     concomitantly with and without Tigan®   "
201574|NCT00489268|"     This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to     evaluate a balloon-based ablation device (HALO360) that delivers a pre-set amount of energy     density (J/cm2) to barrett's tissue. The dosimetry phase evaluated the dose-response and the     safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 delivered twice for     all patients, followed by Esophagogastroduodenoscopy (EGD) with biopsies at 1, 3, 6, and 12     months. A second ablation procedure was performed if Barretts esophagus (BE) was present at 1     or 3 months. A complete response (CR) was defined as all biopsy specimens negative for     Barrett's Esophagus at 12 months. The effectiveness phase of the present study was extended     to a 2.5-year follow-up. This trial incorporated an opportunity for persistent BE to be     treated with a focal ablation device (HALO90), achieving a CR in 98.4% of patients by the     2.5-year follow-up,the results of which were published . There is ample evidence that     RadioFrequency Ablation (RFA) for Barrett's esophagus is effective and safe. Having     additional follow-up (5 years) would add valuable information to the literature, thus aiding     the physician in making patient management decisions about the appropriate follow-up interval     after RFA.   "
201607|NCT00479843|"     The main objective of this study is the improvement of the quality of life and state of     health of elderly people with cognitive deterioration and their families through a weight     loss prevention programme.      The secondary objectives are the improvement of the state of nutrition, a reduction in the     use of resources and a reduction in the burden on the main carer.   "
201608|NCT00479856|"     This study will evaluate the safety and efficacy of lapatinib in combination with     chemotherapy (capecitabine, docetaxel, nab-paclitaxel) in subjects with ErbB2-overexpressing     breast cancer whose disease has progressed during or within 12 months after completion of     trastuzumab-containing therapy in the neoadjuvant or adjuvant setting.   "
201575|NCT00489281|"     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and     total-body irradiation before a donor bone marrow transplant helps stop the growth of     abnormal cells. It also helps stop the patient's immune system from rejecting the donor's     stem cells. When the healthy stem cells from a donor are infused into the patient they may     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and     platelets. Sometimes the transplanted cells from a donor can make an immune response against     the body's normal cells. Giving sirolimus and mycophenolate mofetil after transplant may stop     this from happening.      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide     together with total-body irradiation followed by a donor bone marrow transplant works in     treating patients with sickle cell anemia and other blood disorders.   "
201576|NCT00489294|"     The purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth     hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.   "
201577|NCT00489307|"     The goal of this clinical research study is to learn if dexamethasone can help to control     symptoms such as fatigue, pain, nausea, weight loss, loss of appetite, sleep problems, and/or     depression in patients with advanced cancer.   "
201578|NCT00489320|"     The DEScover Registry is designed to observe the results of using Drug Eluting Stents (DES)     in patients in a real-world setting. The stents being observed are not investigational, that     is, they have been approved for use in the general population.   "
201579|NCT00489333|"     The purpose of this study is to compare the effects of supplementation with ProAlgaZyme (a     novel fermentation product of a freshwater algae ecosystem) vs. placebo on Metabolic Syndrome     and indicators of cardiovascular health including: body weight and fat, blood lipids,     inflammatory markers such as hsCRP, blood pressure and fasting blood glucose.   "
201580|NCT00489346|"     A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent     asthma.   "
201581|NCT00489359|"     The purpose of this study is to determine efficacy of the combination therapy of pemetrexed     and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study     also includes patients with primary peritoneal cancer.   "
201582|NCT00489372|"     This randomized phase I trial is studying the side effects and best dose of     Se-methyl-seleno-L-cysteine in healthy adult men. Studying samples of blood, urine, and     toenail clippings in the laboratory from healthy men receiving Se-methyl-seleno-L-cysteine     may help doctors learn more about how Se-methyl-seleno-L-cysteine works in the body.   "
201583|NCT00489385|"     This study will determine if Albumin-linked interferon (Albinterferon alfa-2b) every 2 weeks     is safe and tolerated by patients infected by both hepatitis C virus (HCV) and human     immunodeficiency virus (HIV). This is a new medication developed for HCV. It may help the     immune system fight infections, especially those caused by viruses. Albinterferon alfa-2b     appears quite similar to other interferons, in side effects and action in controlling HCV.      Patients ages 18 and older who are infected with HCV genotype 1, are HIV positive, are     infected with HCV, and have evidence of HCV-induced liver disease; and who are not pregnant     or breast feeding may be eligible for this study. Many visits to NIH over a 76-week period     are required. There will be collection of blood and urine, pregnancy test, and tests of HCV     in the blood. A liver biopsy is required before start of the study if patients have not had     one within 1 year. Another is done at the end of 72 weeks. An eye exam is done before start     of the study and repeated later. An optional procedure called automated pheresis is done at     the study beginning. Researchers can study patients' immunity to control HCV. Blood is drawn     through a needle in an arm vein and spun in a machine to separate the desired blood     component. Remaining blood is returned to the patient.      Patients will receive Albinterferon alfa-2b at a dose of 900 mcg every 2 weeks for 48 weeks,     by injection under the skin. Ribavirin is given at 1,000 mg or 1,200 mg by mouth twice daily,     depending on a patient's weight. Side effects of Albinterferon alfa-2b are fatigue, headache,     joint and muscle pain, and sleeplessness. The major side effect of ribavirin is anemia.     Visits ranging from week 3 to 44 will determine the safety of Albinterferon alfa-2b and     ribavirin and to see effects on reducing the HCV viral load. For weeks 48, 52, 56, 64, 72,     and 76, patients will return for a clinic visit and blood tests. At week 72, an abdominal     ultrasound and liver biopsy are done. Week 76 includes discussion of biopsy results.   "
201584|NCT00489398|"     Comparison of two allergy drops for enhancing comfort and performance of contact lens wear   "
201585|NCT00489411|"     RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet     known whether duloxetine is more effective than a placebo in treating peripheral neuropathy     caused by chemotherapy.      PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works     compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients     with cancer.   "
201586|NCT00489424|"     This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of     occurrence and the severity of post dose symptoms that may occur during the 3 day period     following a zoledronic acid infusion in post menopausal women with low bone mass.   "
201587|NCT00489437|"     Main Research Question:      Can two new types of test, one called the 4T's score and the other called a rapid assay, help     doctors correctly identify which patients are unlikely to have heparin-induced     thrombocytopenia (HIT)?      HIT is a severe allergic reaction to the blood thinner heparin. This allergic reaction can     lead to heart attacks, strokes, limb amputations, and death. Because heparin is one of the     most commonly used drugs in the hospital setting, it is very important that the investigators     are able to correctly identify who can safely continue to take heparin and who cannot.      It can be very difficult to diagnose HIT because it can look like many other medical     conditions and the best laboratory tests for HIT are difficult to run and only available at     specialized centres.      It would be very helpful if doctors had tests they could use that would tell them quickly and     accurately which patients with symptoms that look like HIT really do have HIT (and require     urgent treatment with another type of blood thinner) and which patients are very unlikely to     have HIT (and could continue to take heparin safely). In this study, the investigators will     compare the 4T's score (a scoring system that assigns points to the presence or absence of     specific clinical features) and a rapid laboratory test with the old laboratory test to find     out if one or both of these types of tests are useful for telling doctors which patients have     HIT and which patients don't have HIT.   "
201588|NCT00489450|"     This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics     (PKs) and safety.   "
201589|NCT00489463|"     The aim of this study was to evaluate the effect of the LNG-IUS and TCU 380A users on the     sub-endometrial vascularization and the uterine artery blood flow using power Doppler     analysis and ultrasonography pulsed color Doppler during the precise mid-luteal phase.   "
201590|NCT00489476|"     The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in     patients with migraine headache with or without aura in a clinical setting.   "
201592|NCT00489502|"     Due to common CVD diseases associated from obesity, medical providers are in a position to     provide assistance. However, less than 10% of all patients receive any weight loss advice     from physicians. Perceived barriers to weight loss counseling include lack of self-control of     their patients and belief that recommendation is futile, lack of medical training in     nutrition, exercise, and obesity management, and lack of insurance reimbursement. Though many     barriers are prevalent, research has demonstrated a positive effect with medical advice on     the number of obese individuals attempting to lose weight. Analyzing data from the 1996     Behavioral Risk Factor Surveillance System, researchers found, when advised to lose weight by     a physician, 78% of overweight patients reported attempting to lose weight. However, if their     physician did not discuss weight loss, only 33% of patients within the same BMI category     attempted to do so 7. From this information, physicians or allied health staff that provide     brief counseling (5-10 minute) along with medical technology that provides basic nutrition     assessment might have a positive impact on the number CVD patients that are obese attempting     to lose weight.      HYPOTHESIS: Will a medical specialty clinic focused on cardiovascular medicine successfully     be able to implement the MedGem device for assessment of basic nutritional needs along with     providing “brief” patient education into the medical practice without a house dietitian.      PRIMARY AIMS        1. Can medical staff and/or support staff provide REE assessments (15-minutes) and brief          patient education (5-15 minutes) as part of the clinic’s operations?        2. Will a third-party payer compensate the Medical Specialty Clinic for the diagnostic          procedure CPT Code 94690 for obese patients diagnosed with hypertension (401.1-9,          402.10-11, & 402.90-91), hypercholesterolemia (272.1), and/or hyperlipdemia (272.2)?      SECONDARY AIMS        1. Does self-efficacy increase from REE assessments?        2. Do patients adopt healthy eating (Calorie Reduction and Fat Reduction)following REE          assessments?   "
201593|NCT00489515|"     RATIONALE: Diagnostic procedures, such as visceral lymphatic mapping using isosulfan blue,     may help find cancer of the pancreas, colon, stomach, small intestine, or gallbladder and     find out how far the disease has spread.      PURPOSE: This clinical trial is studying the side effects and how well visceral lymphatic     mapping using isosulfan blue works in patients with cancer of the pancreas, colon, stomach,     small intestine, or gallbladder.   "
201594|NCT00489528|"     The purpose of this study is to compare physical function and lean body mass in patients     getting different doses of somatropin compared to patients not getting the drug.   "
201595|NCT00489541|"     The purpose of the TAXUS PERSEUS Small Vessel trial is to evaluate the safety and efficacy of     the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS®     ElementTM) for the treatment of de novo atherosclerotic lesions of up to 20 mm in length in     native coronary arteries of ≥ 2.25 mm to < 2.75 mm diameter.   "
201596|NCT00489554|"     The purpose of this study is to assess the immunogenicity in terms of antibody response and     the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse     events following primary vaccination of Mexican infants with pneumococcal conjugate vaccine     GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined     vaccine (Infanrix hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months     of age.   "
201597|NCT00489567|"     This study aims to estimate the burden of RV GE. The study will focus on children     hospitalized for severe RV GE, Children acquiring RV GE in the hospital and the household     contacts of children hospitalized with RV GE. It is expected to enrol 500-600 subjects in the     study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act,     Sep 2007.   "
201598|NCT00489580|"     Study Objectives:        1. To document the safe and effective application of the F.T.M. Arm Training Program using          the SaeboFlex to an inpatient post stroke rehabilitation population.        2. To compare functional improvements in hand and UE use achieved with the F.T.M. program          as compared to generally applied therapeutic treatment approaches.        3. To develop recommendations for an inpatient retraining protocol that could then be          evaluated in a multi-center trial.        4. To document the retention of UE and hand improvements after SaeboFlex training is          discontinued as well as the carry over of these gains into daily function after therapy          has been discontinued.   "
201599|NCT00479739|"     To compare a stable dose of salmeterol/fluticasone propionate with a variable dose of     formoterol/budesonide where the dose is adjusted according to a physician-guided     self-management plan   "
201600|NCT00479752|"     To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in     combination with cetuximab, biweekly.   "
201601|NCT00479765|"     OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release     of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long     period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.      The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed     into the tumor resection cavity in the brain following surgical removal of the tumor. Dose     escalation is conducted by gradually increasing the amount of OncoGel placed in the resection     cavity in small groups of patients, and watching the patients closely for side effects before     moving to the next dose level. The study will also test whether OncoGel helps to prevent or     delay the tumor from regrowing.   "
201602|NCT00479778|"     The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is     given in combination with 2 different formulations of conjugated estrogens. It is an open     label study with no placebo control or comparator drugs. Subjects will take one dose of the     investigation formulation daily for 14 days.   "
201603|NCT00479791|"     A meal rich in very-long chain omega-3 fatty acids or oleic acid may lower postprandial     insulin levels in comparison to a meal rich in linoleic acid or palmitic acid. A meal rich in     very long-chain omega-3 fatty acids may lower postprandial triglyceride levels compared to     other fatty acids.   "
201604|NCT00479804|"     The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac     diseases. The current standard methods for the determination of the CO, however, are either     invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic     resonance tomography, MRT). The traditional non-invasive methods of determining the CO by     rebreathing of carbon dioxide are easily carried out but suffer from methodical inaccuracies.     Therefore the aim of the study at hand was to evaluate a new method for determining the CO by     means of the inert gas rebreathing method.   "
201605|NCT00479817|"     This study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to     estimate the improvement in PFS (compared to control subjects) and evaluate the safety and     tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with     advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.      Primary Outcome Measure:      • Progression free survival (PFS)      Secondary Outcome Measures:        -  Object Response Rate (ORR), duration of response (DOR). CA-125 response rate        -  Safety and Tolerability        -  Change and duration of change on blood levels of CA-125   "
201612|NCT00479921|"     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of     these vaccines are required to be involved in ongoing clinical trials and to present the     results to the competent authorities each year. The current study is a phase IIIa clinical     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It     is part of the ongoing clinical trial program for Influvac® and will be done to assess the     immunogenicity and safety and tolerability of next season's trivalent influenza subunit     vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects     >= 61 years of age (elderly).   "
201613|NCT00479934|"     In vitro studies have shown that imatinib 1mM inhibits strongly the growth of cutaneous     fibroblasts. The hypothesis is that imatinib inhibits PDGFR which is known to be a potential     target for the molecule, as recently also proposed after the discovery of autoantibodies     activating the PDGF receptors. Recent data indicate that TGFb is also a potential target of     imatinib. Cutaneous scleroderma is characterized by progressive cutaneous fibrosis caused by     hyperactive dermal fibroblasts. Since no established treatment for skin sclerosis in     scleroderma is currently available. This study will test the safety and efficacy of imatinib     in the treatment of patients with scleroderma and severe cutaneous involvement.   "
201614|NCT00479947|"     Yeast vaginitis is a very common ailment affecting premenopausal women in Nigeria. This     condition is more prevalent in the age group between 21-30 years. More than 75% of     premenopausal women and university students are diagnosed with yeast infections annually. In     most of these women, recurrent rate of vaginal candidiasis with empiric therapy, stands     between 70 and 80%. In addition, resistance to anti-fungal agents is increasing at an     alarming speed, particularly with species other than Candida albicans such as C tropicalis     and C glabrata. The healthy vaginal environment is composed mainly of lactobacilli and when     these organisms are suppressed overgrowth of a large number of pathogens occur including     yeasts. In this pilot study,we hypothesize that oral administration of two well documented     strains of lactobacilli (L.rhamnosis GR-1 and L.reuteri RC-14 ) given to women with recurrent     yeast vaginitis, following standard therapy with fluconazole will result in a significant     reduction in recurrence rate of the disease.   "
201615|NCT00479960|"     The phospholipids of mammalian spermatozoa possess a distinctive fatty acid composition with     high proportion of long chain polyunsaturated fatty acids. The lipid composition is a major     determinant of the membrane flexibility and sperm motility required for proper fertilization.     It also influences the sperm plasma membrane's fluidity, chilling sensitivity and     thermotropic lipid phase transition (LPT) and these parameters determine our ability to     cryopreserve these cells. Our hypotheses is that by providing dietary supplementation of     omega-3 polyunsaturated fatty acids an improvement of sperm parameters (number, motility,     viability) can be achieved. We also expect alteration spermatozoal plasma membrane fatty acid     composition, making it more chilling resistant.      Experimental methodology: 1) Characterize fatty acid composition of the spermatozoa of normal     and abnormal spermatozoa by gas chromatography. 2) Characterize sperm plasma membrane LPT by     FTIR spectrometer. 3) Run a randomized double-blind, placebo controlled, crossed-over dietary     fatty acid supplementation pilot trial in human sub-fertile patients. Large scale trial will     follow, if justified. In both trials sperm characterization of each participant will be     conducted before, during and following the trial.      Subfertile males will benefit greatly if their sperm parameters can be improved and     cryopreserved while ensuring enhanced post-thawing survival. We believe that changing the     fatty acid composition of sperm plasma membrane by simple dietary means will open the way to     improve the fertility of those that needs it the most.   "
201616|NCT00479973|"     Introduction: According to the World Health Organization (WHO), approximately 150 million     people worldwide have type 2 diabetes. Common and cassia cinnamon have been reported to have     anti-diabetic and lipid-lowering effects.      Objective: To determine if the combination common and cassia cinnamon product Cinnamonforce™     (Cinnamomum verum and C. aromaticum) reduces fasting blood glucose, insulin, glycosylated     hemoglobin (HA1C), triglyceride, total cholesterol, HDL cholesterol and LDL cholesterol     levels in people with type 2 diabetes.      Methodology: Seventy (70) type 2 diabetic participants will be randomized to receive either     140 mg of Cinnamonforce twice daily or placebo over 12 weeks. Physical and laboratory     measurements will be taken at baseline, 2 weeks, 4 weeks, 8 weeks and at the end of the     trial, 13 weeks.      Results: The differences in the measurements obtained from the group receiving Cinnamonforce     and the placebo group will be analyzed and discussed.   "
201617|NCT00479986|"     The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone     (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well     as the degree of activation of the immune system, when given on top of an anti-diabetic     treatment (metformin and/or sulfonylurea drugs) that has already resulted in good glycemic     control.   "
201618|NCT00479999|"     This study will test whether two experimental HIV vaccines are safe and whether they cause     any side effects in healthy adults. It will examine the body s immune response to the     vaccines and monitor the social impact, if any, of being in an HIV vaccine study. The     experimental vaccines in this study are the VRC-HIVADV027-00-VP (also called the rAd35-EnvA     vaccine) and VRC-HIVADV038-00-VP (also called the rAd5-EnvA vaccine). The vaccines are made     using an adenovirus (virus that normally causes respiratory infections and colds) that has     been modified to contain DNA that codes for HIV proteins. The vaccines cannot cause HIV or     adenoviral infections.      Healthy normal volunteers between 18 and 50 years of age may be eligible for this 2-part     study. Part 1 includes 15 people. Part 2 includes 20 people.      Part 1 participants receive only the rAd35-EnvA vaccine. The first five people enrolled     receive the lowest study dose of the vaccine. If this dose is safe, then the next five people     enrolled receive a higher dose. If this dose is safe, then the last 5 people enrolled receive     the highest study dose. Subjects in Part I have about five clinic visits over 24 weeks.      Part II of the study starts after all injections in Part 1 are given. Subjects in Part 2 are     randomly assigned to one of two vaccination schedules. One group receives the rAd35-EnvA     vaccine first, followed 12 weeks later with the rAd5-EnvA vaccine. The other group receives     the vaccines in reverse order; that is, first the rAd5-EnvA vaccine, followed 12 weeks later     with the rAd35-EnvA vaccine. In this schedule, the first vaccination primes the immune system     and then the immune response is boosted 12 weeks later with a different vaccine. Everyone in     study Part 2 receives the rAd35-EnvA vaccine at the middle dose tested in Part 1. Subjects in     Part 2 have about eight clinic visits over 36 weeks.      All vaccinations are given as injections in the upper arm. At each clinic visit, participants     are checked for health changes or problems. They are asked how they are feeling and if they     have taken any medications. Urine samples are collected and blood is drawn at some visits.     They are tested for HIV several times and asked questions about their sexual behavior and     drug use. Throughout the study, participants are counseled on HIV risk reduction. Subjects     are asked about any social effects they may have experienced from their participation in this     study.   "
201619|NCT00480012|"     Rapid Transcranial Magnetic Stimulation will be used in order to examine whether the human     primary visual cortex is essential to visual memory consolidation.   "
202127|NCT00486720|"     This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients     with lower risk Myelodysplastic Syndrome (MDS).   "
201622|NCT00480051|"     Patients who have heart failure and have electrical evidence of delay in the contraction of     the left ventricle on an ECG tracing of the heart are eligible for biventricular pacing.     Recent work has suggested that patients with heart failure who do not have electrical     evidence of conduction delay (normal QRS) may benefit from biventricular pacing. The reliance     on ECGs to determine the presence of dyssynchrony is widespread, although the ECG alone is     not 100% sensitive and specific. ECG criteria for de-synchrony in heart failure patients are     estimated to pick up only 30% of patients with dyssynchrony, and results in patients missing     out on a potentially important treatment advance.      We would like to study patients with heart failure who have normal ventricular activation on     their ECGs to see whether we can predict those patients who will respond to biventricular     pacing.   "
201623|NCT00480064|"     A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and     Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\m2 orally at day 1).     Patients in complete remission (CR) were then randomized to receive either maintenance     therapy or intensification with intermediate-dose cytarabine and idarubicin followed by     maintenance therapy.   "
201624|NCT00480077|"     The DOT-HF trial is an international, prospective, multi-center, randomized, controlled     trial.   "
201625|NCT00480090|"     This is a single-arm, open label phase II trial of the investigational agent, Ara-C     (cytarabine), in patients diagnosed with hormone refractory prostate cancer whose disease has     progressed on or deemed not suitable for standard chemotherapy with docetaxel. Ara-C appears     to inhibit DNA synthesis and is cytotoxic to a wide variety of mammalian cells. Recent     discoveries have suggested the role of gene fusions in the ETS family of transcription     factors as important for the development of prostate cancer. Ara-C appears to block ETS     genes, suggesting that it is worthwhile to explore Ara-C as a potential new treatment for     patients with hormone refractory prostate cancer given that there is no standard of care for     the proposed patient population. In this study, Ara-C will be administered intravenously for     2 days every 3 weeks (1 cycle). Treatment will be for 6 cycles if tolerated and may be     continued in patients who are responding and do not have severe toxicity.   "
201626|NCT00480103|"     We aim to compare the morphological and chromosomal features of human embryos cultured In     Vitro versus those developed in a new In Vivo culture system with encapsulation in utero as     well as implantation and pregnancy rate.   "
201627|NCT00480116|"     The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and     immuno-compromised individuals who could have or had a sub-optimal response following     vaccination for hepatitis B with currently available commercial vaccines (target population).     This study will aim to confirm in a clinical setting the consistency of production of three     lots of the vaccine.   "
201628|NCT00480129|"     We hypothesize that specifically selected probiotics can alleviate symptoms of allergy in     lactose tolerant individuals. Two strains of probiotics, Lactobacillus rhamnosus GR-1, and     Bifidobacterium adolescentis 7007-05 will be used to create a yogurt product. Additionally a     non-probiotic yogurt product will also be made as a placebo. Allergy sufferers will be asked     to consume one of the two types of yogurts (blinded) for two months. During the two months     there will be 3 sampling days, for blood samples and nasal lavage samples. Additionally Mini     Rhinoconjunctivitis Quality of Life Questionnaires will be filled out weekly over the two     months. After the two months of perceived responses as well sample analysis we should have a     better idea of how these specific probiotic effect the immune system and allergies.   "
201629|NCT00480142|"     A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule     Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia     Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH).      CRO is indicated for the management of moderate to severe pain when a continuous,around the     clock analgesic is needed for an extended period of time.Its safety and efficacy in the first     12-24 hours post operative has not been established.   "
201630|NCT00480155|"     To assess the safety of a vaccine in healthy adults prior to the release of the vaccine     (FluMist®) containing it.   "
201631|NCT00480168|"     The purpose of this study is to observe patients aged 6-18 with various psychiatric diagnosis     being treated with drugs called atypical antipsychotics to determine the effects of the drugs     on growth, weight gain, and laboratory tests.   "
201632|NCT00480181|"     The purpose of this study is to determine whether nabilone (Cesamet) when used as an     adjunctive agent with gabapentin (Neurontin) provides significantly improved pain relief over     gabapentin alone for the management of neuropathic pain in MS.   "
201633|NCT00480194|"     The objectives of the study are to obtain knowledge about the safety in use, the patients'     general impression of the treatment and the pattern of use of ZyComb® in an over-the-counter     (OTC) setting.   "
201634|NCT00480207|"     Our specific aim is to determine the impact of folic acid and omega-3 supplementation on the     severity of depressive symptoms among depressed adults aged 65 and above.   "
201635|NCT00480220|"     The main objective of this work is to assess the feasibility and efficacy of a specific Care     and Assistance Plan for Alzheimer's disease (PLASA). The main outcome measure selected is     incapacity in carrying out the basic activities of daily living, evaluated by the ADCS-ADL     scale .      The PLASA was developed by a working group appointed by the Direction Générale de la Santé as     part of the government programme of action on Alzheimer's disease (October 2001, Ministère de     l'Emploi et de la Solidarité).   "
201636|NCT00480233|"     Depression is common in primary care and general medical settings, but is often unrecognized     and untreated by physicians working in those settings.      The Patient Health Questionnaire for depression (PHQ-9) is well validated and widely used     screening instrument.   "
201637|NCT00480246|"     This is a single dose, open-label, 2-panel (Parts A and B) PET study investigating the degree     of occupancy of dopamine 2 receptors (D2_RO) in the human brain after single oral doses of     BL-1020 or Perphenazine (Trilafon®, hereafter called Perphenazine) in healthy male subjects.     In Part A the D2_RO is investigated for the study compound BL-1020 and in Part B the D2_RO of     BL-1020 is compared to the D2_RO of Perphenazine, a reference compound.   "
202128|NCT00486733|"     The purpose of this study is to determine if adding shock wave therapy to standard-of-care     wound treatment for traumatic extremity wounds helps them heal faster.   "
201641|NCT00480298|"     This study is a double-blinded, randomized, placebo controlled, multi-center trial in which     120 subjects with nasal polyposis (NP) will be treated during 20 days with oral     corticosteroids (OCS) in decreasing doses or oral doxycyclin (ODOX) or placebo. At each visit     the clinical and the biological activity will be assessed by nasal peak inspiratory flow     (nPIF), symptoms, olfactory test, endoscopic evaluation of nasal polyps, peripheral     eosinophil levels and markers of inflammation IL-5, IL-5 receptor alpha, ECP, TGFβ1, IgE and     specific IgE in serum and nasal secretion.   "
201642|NCT00480311|"     The main purpose of this study is to determine the measurement characteristics of WHODAS-II     (World Health Organization Disability Assessment Schedule II), as well as to analyze its     correlation with symptomatic lumbar spinal stenosis (Visual Analog Scale, VAS), disability     (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and     attitudes (Spanish version of the FAB Questionnaire, FABQ), and quality of life (SF-12).     Measurements will be taken at baseline and 6 days later (day 7).   "
201643|NCT00480324|"     This study is undertaken to provide the regulatory authorities in Japan with immunogenicity,     efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine,     given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2     months at the time of the first dose and previously uninfected with HRV. The Protocol Posting     has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
201644|NCT00480337|"     The aim of this study is to aspirate immature oocytes from antral follicles and mature the     oocytes in vitro. These mature oocytes will serve for fertilization and the creation of     embryos which will be replace in the uterus as performed during normal IVF.We will record the     efficacy and safety of this procedure.   "
201645|NCT00480350|"     HIV infection is a growing problem in Israel with over 4000 known patients who are either     infected with the virus or have developed AIDS. Patients are usually followed for years until     they develop an increase in their viral load (HIV-1 RNA) or their CD4 + cells decline. At     this point, patients are usually treated with Highly Active, Anti-Retroviral Therapy (HAART).     The mainstay of response to such treatment is the lowering of viral load and increase in CD4+     cells. Food supplements for HIV patients have been given in several studies, with     controversial results. A meta-analysis published recently [1] assessed whether micronutrient     supplements are effective in reducing morbidity and mortality in adults and children with HIV     infection. They recommended supporting the current WHO recommendations to promote and support     adequate dietary intake of micronutrients wherever possible. We expect to enroll 140 subjects     in this randomized, double blind, placebo controlled study. Seventy subjects will be enrolled     in the rice-supplement arm and 70 subjects in the control group, which will receive     supplemental, flavored dextrose to their current medical treatment. The treatment duration is     24 weeks with follow-up at 36 weeks from enrollment. The target population is HIV-1 infected     individuals who may be either on anti-retroviral therapy or not on therapy. Subjects must be     with either CD4+ cells are <500 cells/mm3, or HIV plasma RNA level is > 5000 copies/ml. The     primary objective is to demonstrate the efficacy of food supplementation versus a     flavored-dextrose supplement with respect to increment of patient CD4+ cell count from     baseline at 24 weeks, or virological response defined as lowering of plasma HIV-1 RNA and     immunologic response.   "
201646|NCT00480363|"     The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the     time to progression to symptomatic MM in patients with smoldering MM. The second one is to     evaluate the efficacy of the treatment in response rate terms. Otherwise this study wants to     evaluate the safety and tolerability of the treatment   "
201647|NCT00480376|"     Prostate biopsy is usually conducted transrectal, ultrasonography guided. Since the area is     not sterile, infection can be induced during the procedure.      Prophylaxis antibiotic against gram-negative bacteria decreased significantly the amount of     infections. Quinolones are considered preferred treatment but there is already an increase in     resistance rates. TMP-SMX can not be used empirically due to a high percent of resistant     uropathogens. One of the options is aminoglycosides, especially gentamicin. Advantages: very     low resistance rate in the community, high concentration is urinary tract, slow clearance, no     resistance developed under treatment, chip and with very few side effects.   "
201648|NCT00480389|"     The purpose of this study is to see if preoperative administration of Sorafenib reduces the     size of the primary kidney tumour in patients with metastatic disease undergoing     cytoreductive surgery.      The study will also assess the safety of preoperative Sorafenib.      The study drug, Sorafenib, will be given to patients preoperatively for 12 weeks. After a 1     week washout period the patient will then have their nephrectomy (kidney removed).     Approximately 6 weeks following their nephrectomy, patients will resume on study drug until     disease progression.   "
201649|NCT00480402|"     To assess the effectiveness of natural progesterone supplementation in preventing preterm     births in twins.   "
201650|NCT00480428|"     Residents of certain villages in Kazakhstan were exposed during childhood to radioactive     fallout from nuclear tests conducted at the Semipalatinsk Nuclear Test Site (SNTS) between     1949 and 1962.      Radiation doses to the thyroid from external and internal (i.e., ingested) radiation sources     deposited as fallout are of interest because they may be jointly and differentially     associated with increased risk of thyroid disease in this population.      Objectives:      To collect information about factors influencing radiation dose to the thyroid gland in     children of two ethnic groups who were exposed to radioactive fallout from nuclear tests at     the SNTS between 1949 and 1962. The two groups are Kazakhs (historically nomadic herders) and     Europeans (typically descendants of Russian and German farmers).      Eligibility:      Women 70 years of age and older who had children or provided care to children during the     1950s.      Men age 70 and older who were engaged in farming and care of dairy animals at the time of the     nuclear tests.      Design:      In focus group format, participants are interviewed to collect information on the following     at the time of nuclear tests:        -  Dairy consumption;        -  Source, storage and availability of milk and milk products;        -  Time that children of different ages and ethnic groups spent indoors;        -  Building material of houses and schools;        -  Herding, grazing and supplemental feed of dairy animals.   "
201909|NCT00489866|"     The proposed investigation will determine the therapeutic potential of aripiprazole     augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder     (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans     with PTSD.   "
201651|NCT00480441|"     This treatment study is targeted specifically for those who want to stop using marijuana. We     want to find out if patients who are dependent on marijuana and want to stop using are helped     by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA).     Dronabinol is a pill form of the active ingredient in marijuana (THC). Currently, dronabinol     is approved for the treatment of nausea in people receiving cancer chemotherapy and as an     appetite stimulant in people with AIDS.      In some studies, dronabinol reduced the amount of psychological and physical discomfort     experienced when people stopped using marijuana. One purpose of our study is to see if people     who are on dronabinol have fewer problems with psychological and physical discomfort than     those who are on a placebo.      In addition to treatment, this research trial will also be measuring the reactions of     subjects to drug-related cues, and also to computer-presented tasks unrelated to drug use. We     may examine whether the response to these cues/tasks either predicts treatment outcome, or is     affected by your treatment. This information may also help us to understand the ways in which     chronic drug use causes changes in our subjects' mental functioning and how those changes     respond to treatment.      In addition to participation in the treatment research trial, some subjects may be asked to     undergo a brain scan in an MRI. The purpose of the brain scan research project is to measure     brain reactions with a non-invasive, non-radioactive imaging technique known as fMRI     (functional magnetic resonance imaging) in marijuana subjects before and after treatment with     the medication dronabinol or with an inactive substance (placebo).   "
201652|NCT00480454|"     This study is preliminary to proving that this vaccine could protect against tuberculosis in     humans. Although there is no proven data to show that infants will benefit directly from     participation in this study by being protected against TB, MVA85A protection of mice, guinea     pigs and monkeys against tuberculosis is encouraging. It is hoped that the information gained     from this study will contribute to the development of a safe and effective TB vaccine for HIV     negative and positive individuals. Participants in this study will benefit by having     information about their general health status, and the rigorous follow up visit that could     enhance early detection and management of medical conditions that might arise in the course     of the study.   "
201653|NCT00480467|"     To assess the safety and tolerability of ascending single oral doses of SAM-315, an     investigational drug, in healthy Japanese male subjects.To obtain preliminary pharmacokinetic     (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy Japanese male subjects.   "
201654|NCT00480480|"     Context: This is the first multi-site randomized controlled study of the effectiveness of a     group treatment for war-exposed adolescents delivered in-country within a public school     system.      Objective: To evaluate the effectiveness of a trauma/grief-focused group treatment program in     reducing symptoms of posttraumatic stress disorder (PTSD), depression, and traumatic grief in     war-exposed Bosnian youths attending 10 secondary schools located in Central Bosnia.   "
201655|NCT00480493|"     This RCT intervention provides parental social support (informational, affirmational, and     emotional) using parent mentors (experienced in the management of the chronic illness) for     mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent     mentors provide both home visits and phone call support over the course of the first year     after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention     will perceive less parental concern and worry, less negative impact on the family, more     perceived confidence and social support compared to those mothers and fathers not receiving     the intervention.   "
201656|NCT00480506|"     The purpose of this study is to collect peripheral blood and bone marrow aspirate samples     from thalassemia patients in Tehran, in a collaborative effort to develop an erythroid     lineage specific chimerism assay applicable to patients with thalassemia. Development of such     an assay would be useful both for identification of the exact mutation causing the disease,     as well as for providing a direct method to measure and monitor the kinetics of donor     erythropoiesis in this patient population following transplant.   "
201657|NCT00480519|"     The aim of the study is to prospectively investigate the feasibility, pain control, and     outcome of meatotomy performed under sedation and local anaesthesia compared with general     anaesthesia with and without patient block   "
201658|NCT00480532|"     The purpose of this study is to learn if the study drug, doxycycline, can decrease the amount     of unplanned vaginal bleeding that women commonly experience when taking combined oral     contraception (COC)- pills with estrogen and progestin - in a continuous fashion - no     hormone-free week. The study drug, doxycycline, is an antibiotic used commonly for many     conditions (i.e. acne, Chlamydia infections, pneumonia) and can be safely used on a daily     basis. Doxycycline has been shown to decrease unplanned vaginal bleeding in progestin-only     contraception but has not been studied in combined hormonal contraception.   "
201659|NCT00480545|"     Indirect evidence suggests that hormonal fluctuations during the menstrual cycle also affect     the bleeding and clotting system. This study looks at two sensitive laboratory tests at four     time points during the menstrual cycle to determine if there is a natural variation in     coagulation and platelet function. Laboratory tests in healthy subjects will be compared to     women with von Willebrand's disorder type 1, a bleeding disorder. In the future, these     laboratory tests may help in the diagnosis of bleeding and clotting disorders and to design     treatments for women with abnormal menstrual bleeding.   "
201660|NCT00480558|"     This study is designed to evaluate the safety of MVA85A in asymptomatic volunteers in South     Africa who are infected with M.tb, HIV or both. A single vaccination with MVA85A, when     administered at a dose of 5 x 107pfu intradermally, is safe and highly immunogenic in     mycobacterially naïve individuals, BCG vaccinated individuals and M.tb latently infected     individuals. We will use the same vaccination regime in this study. Participants will be     defined as being infected with M.tb.if they have a positive Elispot response to ESAT6 or     CFP10. Participants will be defined as being infected with HIV.if they have a positive HIV     rapid test (Determine®, Abbott Laboratories) followed by a positive HIV ELISA result.     Participants will be identified from the general population living in Worcester, Western     Cape, South Africa   "
201661|NCT00480571|"     An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety     and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic     schizophrenia or schizo-affective disorder   "
201910|NCT00489879|"     The purpose of this study is to determine whether cellular phone based health care system is     effective in the treatment of diabetes and hypertension.   "
201662|NCT00480584|"     This is a phase I clinical trial examining the safety, feasibility, and toxicity of     gemcitabine and erlotinib when given in combination with capecitabine in adult patients with     locally advanced unresectable or metastatic pancreatic adenocarcinoma.      Treatment will be administered at Moffitt on an outpatient basis and consists gemcitabine     once per week for 3 weeks, followed by a week off treatment. Erlotinib (tablet) taken by     mouth continuously starting with day one of cycle 1 with capecitabine taken twice per day on     days 1-14 of each cycle followed by a 2 week off treatment rest period. An accelerated     dose-escalation scheme will be employed with 4 planned dose levels. Whenever patients have     been enrolled at a given dose with at most 1 DLT, the protocol will be stopped and the dose     will be called the maximum tolerated dose (MTD). Patients will be treated at the recommended     phase II dose (RPTD) to confirm tolerability at that dose.      In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles     or until disease progression and patients may continue on the study regimen unless they     experience an adverse event that meets the criteria for a dose limiting toxicity.   "
201663|NCT00480597|"     Development of an active second-line treatment option for metastatic breast cancer patients     previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative     settings.      For each randomisation arm, 47 patients will be included. The trial was performed as a     2-stage phase II study according to the optimal design by Simon with overall response rate as     the primary objective.      Study Design:      Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks      Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks      Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks   "
201664|NCT00480610|"     Long-term tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice     daily treatment and subsequent twice weekly prophylactic application can effectively treat     active lesions of atopic dermatitis and prevent delay & reduce flares   "
201665|NCT00480623|"     This study is designed to measure the impact of Satraplatin plus radiation therapy to the bed     of the prostate in patients who have developed biochemical failure of their prostate cancer.     The main objective of this study is to determine the maximum tolerated dose and dose limiting     toxicity for the combination of satraplatin and radiation therapy and to determine the     recommended dose for subsequent Phase II trials.   "
201666|NCT00480636|"     To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein     thrombosis with or without pulmonary embolism in cancer patients.   "
201667|NCT00480649|"     The primary study objective is to demonstrate the clinical effectiveness of SERETIDE therapy     compared to the current care in management of moderate to severe persistent asthma patients     in Korea.   "
201668|NCT00480662|"     To test the safety, effectiveness of MK0217 when taken once a week for six months in treating     patients with Paget's bone disease.   "
201669|NCT00480675|"     The goals of our research project are to study the relationship, if any, between the success     of a TB injection (measured by pain relief and general patient satisfaction) and the method     in which it was placed. Because fluoroscopy places patients requires a slight risk from     radiation exposure and increased cost versus blind injection, it is important to know if     there is an advantage to using this technique. The investigators will randomize 64 patients     to receive either trochanteric bursa injections with corticosteroid and local anesthetic     guided by fluoroscopy, or trochanteric bursa patients to receive trochanteric bursa     injections based on landmarks on palpation. The investigators will then determine which     method is superior, and whether injecting steroid and local anesthetic into the bursa itself     is superior or inferior to injecting it into a tender area outside the bursa.   "
201670|NCT00480688|"     To assess the immunogenicity of M. bovis BCG, given intrademally in the standard dose used in     clinical practice and to measure the development of the immune response in the first six     months after administration. M. bovis BCG is a fully licensed vaccine that has been in     routine clinical use for the last 50 years. It is the most widely administered vaccine in the     world today and has an excellent safety record.   "
201671|NCT00480701|"     The underlying goal of this study is to assess 123-I IBVM SPECT imaging as a tool to assess     cholinergic transporter binding in the brain of AD and PD research participants and age- and     gender-matched healthy subjects.   "
201672|NCT00480714|"     To assess the immunogenicity of M. bovis BCG (SSI strain), given intrademally in the standard     dose used in clinical practice and to measure the development of the immune response in the     first six months after administration. M. bovis BCG is a fully licensed vaccine that has been     in routine clinical use for the last 50 years. It is the most widely administered vaccine in     the world today and has an excellent safety record.   "
201673|NCT00480727|"     The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain,     pin loosening and pin replacement.   "
201674|NCT00480740|"     The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and     pharmacogenomics of dexmedetomidine in the following three pediatric patient populations:     patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who     have had a cardiac transplant, and patients with otherwise normal physiology who are     undergoing closure of a patent ductus arteriosis or atrial septal defect.   "
201675|NCT00480753|"     The purpose of this clinical study is to determine the response to two different dosage     strengths of a topical nitroglycerin gel in patients with Raynaud's Phenomenon. Patient     fingers will be monitored for changes in blood flow and skin temperature. Symptoms of pain,     tingling and numbness will also be monitored.   "
201676|NCT00480766|"     A research study to see how safe and effective MK0217 is when taken weekly for the prevention     and treatment of steroid induced bone loss.   "
201700|NCT00481117|"     This study intends to evaluate how safe and well tolerated the LY2405319 compound is when     given to people for 7 days (in Part 1) and 28 days (in Part 2). This study intends to also     determine if there is a positive effect on lowering the level of glucose in people with type     2 diabetes.   "
201740|NCT00481637|"     The purpose of this study is to study whether immune cells capable of killing tumors that     express proteins associated with paraneoplastic neurologic syndrome (PNS) can be found in     small cell lung cancer and ovarian cancer patients. The presence of these cells may play a     role in tumor immunity in these patients. The protocol involves neurological examinations and     collection of blood.   "
201677|NCT00480779|"     The purpose of this study is to examine different methods of delivering the Group Lifestyle     Balance (GLB) intervention (1). The GLB is a 12-week lifestyle change program based on the     highly successful lifestyle program that was used in the Diabetes Prevention Program     (DPP)(2). A DVD of the Group Lifestyle Program has been developed. Conditions called     metabolic syndrome and pre-diabetes increase the risk of diabetes and heart disease. Recent     research has shown that type 2 diabetes and metabolic syndrome may be prevented or delayed by     making lifestyle changes. A primary care practice will enroll participants who will choose     either the GLB-DVD intervention or face-to-face group delivery. Approximately 25 patients     will be recruited in each group. It is not known if the GLB intervention delivered via DVD is     similarly effective to face-to-face group delivery for people with metabolic syndrome or     pre-diabetes. It is hoped that this research study will provide information to help answer     that question.   "
201678|NCT00480792|"     In HIV infected patients, individuals exposed to the virus of Hepatitis B are more     susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and     liver cancer.      However, the existing protocol of vaccination against Hepatitis B is less efficient in     HIV-infected patients than in non HIV-infected-patients, and, in case of response, its     longevity has to be followed up carefully. This study compares the efficacy of the standard     protocol vaccination with GenHevac-B and 2 other protocols, a double-dose of GenHevac-B and a     set of intradermal injections of Genhevac-B, in HIV-infected patients with lymphocytes T CD4     level above 200 permm3.   "
201679|NCT00480805|"     A study to test the safety and efficacy of HYZAAR as compared to Ramipril in patients with     type 2 diabetes mellitus (high blood sugar) and hypertension (high blood pressure).   "
201680|NCT00480818|"     To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an     investigational drug, in healthy young adult and elderly subjects.To assess the     pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in     healthy young adult and elderly subjects.   "
201681|NCT00480831|"     This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a     background of effective treatment designed to evaluate the efficacy, safety, and     pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in     patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung     cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.   "
201682|NCT00480844|"     In this study we intend to compare the effect of Sertindole to that of Risperidone on     cognitive impairment in schizophrenia.      Hypothesis: Sertindole will be as effective as Risperidone for treating cognitive impairment     in schizophrenia and with fewer side effects.   "
201683|NCT00480857|"     The main purpose of this study is to try to find out whether adding chemotherapy to the     standard treatment for your stage of prostate cancer is more effective than the standard     treatment by itself. The kind of treatment that most physicians would consider standard for     this stage of prostate cancer is radiation therapy alone, possibly in combination with     hormonal therapy. In this study, all patients will receive chemotherapy and radiation     therapy. It is hoped that chemotherapy will be found to provide additional benefit, but     chemotherapy has significant side effects. The use of chemotherapy is experimental in     prostate cancer; it needs to be tested to determine if it is beneficial and to find out more     about the side effects of the two different treatments. This study is to determine the     effects, good and/or bad, of adding chemotherapy to radiation therapy as salvage treatment     for recurrent prostate cancer after surgery.   "
201684|NCT00480870|"     The purpose of this study is to determine the effects of the anticholinesterase drug     donepezil on sleep in Alzheimer disease patients. Sleep structure and respiratory parameters     will be analyzed by polysomnography.   "
201685|NCT00480883|"     Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries,     that has shown an increasing incidence over the last many decades. For the last 60 years     antimony compounds are considered the treatment of choice. Though their use is expensive,     cumbersome, has many adverse effects and not effective in all patients, the search for a     better alternative is still going on. Low dose antimony compounds in combination with several     agents have shown promise of reducing adverse effects of antimony compounds without     compromising efficacy. Allopurinol is one such agent which though promising lacks randomized,     controlled trials to prove efficacy. The main objective of this study is to evaluate low dose     sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium     stibogluconate in terms of efficacy and adverse effects.      Methods and design: A multi-center randomized, controlled trial including 620 patients from     endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research     question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study.     After evaluating the inclusion/exclusion criteria patients will be randomized to receive     either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a     maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and     allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During     treatment patients will be admitted to hospital and monitored daily for the presence of     adverse effects. Follow up period will last six months during which patients will visits the     research centers for assessment of healing process at monthly intervals.   "
201686|NCT00480896|"     A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial     twice daily treatment and subsequent twice weekly prophylactic application can effectively     treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.   "
201727|NCT00481468|"     We are evaluating a new computer software package to help us acquire and interpret heart CT     studies, which is the purpose of this research project. We plan to compare the acquiring and     analysis of heart artery calcium scores and CT angiograms (scans of the heart arteries) with     the new SYNGO Somaris/7 Cardiac software to our previous experience with the the existing     Siemens software and the TeraRecon software (current software used in the Cardiovascular     MR/CT lab). The main objective of this study is to provide information to Siemens regarding     the ease of use and capability of the scanner's software. The goal of this study is to     determine whether the acquisition and interpretation information with the new software     functionally meets the guidelines specified by Siemens, and also to determine whether the     software is equivalent or superior to previous versions we used from April 2004 to April     2006.   "
201687|NCT00480922|"     There has been a recent increase in incidence of obesity and its associated morbidities,     including T2 DM, hypertension and hepatic steatosis. Hepatic steatosis is a precursor to     non-alcoholic steatohepatitis, cirrhosis and end-stage liver disease. The 1st reported case     of pediatric hepatic steatosis was in 1980 and it is now affects 30-77% of overweight     children. In addition to its association with obesity, hepatic steatosis has been associated     with the metabolic syndrome, insulin resistance, and post-prandial hyperglycemia. Current     treatment of hepatic steatosis includes weight loss with a hypocaloric low fat diet. Given     the association with insulin resistance and post-prandial hyperglycemia, adult patients with     hepatic steatosis that does not respond to weight loss are placed on insulin sensitizing     drugs. We hypothesize that weight loss with a diet designed to decrease insulin resistance     and post-prandial hyperglycemia, a low glycemic load diet, will provide a safe and effective     way to decrease hepatic fat content in the pediatric population. This hypothesis will be     tested with a randomized control trial comparing the effect of a low fat diet with a low     glycemic load diet.   "
201688|NCT00480935|"     Study Hypothesis: Patients with local renal cell carcinoma who are treated neoadjuvantly with     Sutent may show a radiologic response to the study drug (Sutent).      The study is looking at the neoadjuvant (pre-surgery) administration of Sutent in patients     with localized kidney cancer. The purpose of this research is also to evaluate both the     safety and effectiveness of Sutent in this patient population.   "
201689|NCT00480948|"     The purpose of this study is to demonstrate the efficacy of infant formula having proportion     of palmitate in the sn-2 position comparable to human milk in Chinese term infants.   "
201690|NCT00480961|"     This research study was designed to test the safety and effectiveness of autologous stem cell     graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with     ischemic etiology. Cellular implantation will take place during off-pump revascularization     surgery or during an ad hoc procedure using a mini-thoracotomy access.   "
201691|NCT00480974|"     Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with     significant decrease in the frequency of vaso-occlusive crises and other crises related to     SCA. Several studies were published with relative short term follow up in pediatric and young     adult age. The purpose of this study is to assess the long term follow up in a group of     patients that initiated Hydroxyurea treatment in childhood.   "
201692|NCT00480987|"     The goal of this clinical research study is to find the highest tolerable dose of oxaliplatin     combined with fludarabine plus cytarabine that can be given to patients with Acute Myeloid     Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS). Once the highest tolerable dose     of oxaliplatin in this drug combination is found, the next goal of the study will be to learn     the safety and the ability of the drug combination to control the disease.   "
201693|NCT00481000|"     The purpose of this study is to determine whether Dialectical Cognitive Traumatherapy is     effective in the treatment of severe and chronic Posttraumatic Stress Disorder (PTSD)     following childhood sexual abuse.   "
201694|NCT00481013|"     The primary objective of this proposal is to determine whether oral VPA is effective in     treating SMA in adult patients.   "
201695|NCT00481026|"     The project will investigate the use of a novel technique, transcranial direct current     stimulation (tDCS) in the treatment of patients with schizophrenia and patients with     depression. tDCS involves the application of an extremely weak continuous electrical current     to the brain through the placement of anode and a cathode on the scalp. The electrical     current is generally completely imperceptible after initial period of tingling which takes     about 30 seconds. Stimulation under the anode appears to increase brain activity where as     stimulation under the cathode has the opposite effect. This research plan involves two     clinical trials:        1. A study using tDCS to treat both the positive and negative symptoms of schizophrenia.          The negative symptoms of schizophrenia such as lack of motivation and energy appear to          arise due to a lack of activity in frontal brain areas. Positive symptoms such as          hallucinations and confused thoughts may arise through over activity of brain areas more          on the side and towards the back of the brain called the temporal cortex. We plan to          apply tDCS such that it can simultaneously increased activity in these frontal brain          areas and reduce activity over temporal cortex. We will compare active stimulation to a          placebo condition which involves turning the stimulator off after 30 seconds. The          capacity to target multiple symptom clusters is unique with this type of brain          stimulation.        2. The study using tDCS in treatment resistant depression builds on a work with          transcranial magnetic stimulation (TMS). TMS techniques in depression seem to work which          increased left frontal brain activity or decrease right frontal brain activity. tDCS          will be used to do the same thing with the anode used to increase left-sided brain          activity and the cathode used to simultaneously decreased right-sided brain activity.      tDCS is potentially a better tolerated procedure than TMS and does not appear to have the     same risk of seizure induction. Importantly, the equipment is quite inexpensive and this may     prove to be an extremely safe and effective low-cost treatment for psychiatric disorders in     Third World countries.   "
201696|NCT00481039|"     Sickle cell anemia and sickle cell thalassemia are frequent diseases among the israeli arab     population. The purpose of this study is to assess the clinical characteristics of the     patients in one arab village and the laboratory characteristics in the carriers of this gene     based in the screening for pregnant women that is carried out in the population of northern     Israel.      The results can be useful in order to institute universal screening for sickle cell anemia in     northern Israel.   "
201697|NCT00481052|"     Treating Ph pos CML with Imatinib is very effective since the majority of the patients     achieve a complete cytogenetic response and a major molecular response and are alive and     progression-free after 5 years. However, the great majority of responding patients are not     leukemia-free and may be at risk of progression, molecular, cytogenetic and clinical, at any     time. In case of disease progression due to Imatinib failure, nilotinib has been found to be     very effective, as expected from the preclinical profile of the drug, that is much more     potent against BCR-ABL and inhibits nearly all the imatinib-resistant BCR-ABL mutants. For     these reasons, nilotinib is going to be registered for the treatment of imatinib-resistant     CMl patients. For the same reasons, nilotinib is expected to be more efficient than imatinib     also front-line, based on the principle that we should aim at preventing the emergence of     resistance better that at treating resistance once it has emerged. This expectation can be     tested safely, because the toxicity profile of Nilotinib may be even more convenient than     that of Imatinib, due to the lower frequency of edema and fluid retention.   "
201698|NCT00481091|"     The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of     ABT-263 under two different dosing schedules with the objective of defining the dose limiting     toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263     at the defined recommended Phase 2 dose to obtain additional safety information and a     preliminary assessment of efficacy. The Extension Study portion will allow active subjects to     continue to receive ABT-263 for up to 7 years after the last subject transitions with less     frequent study evaluations.   "
201699|NCT00481104|"     Purpose of the study is to evaluate the long term safety of tesofensine in obese patients   "
201701|NCT00481130|"     Over the past 30 years much has been learned about the molecular genetics and natural history     of familial forms of hematuria. However, the enhanced understanding of these conditions has     yet to generate effective therapies for Alport syndrome, the form of familial hematuria     associated with end-stage renal disease. Males with Alport syndrome inevitably develop     end-stage kidney failure, with a 50% likelihood of dialysis or kidney transplantation by age     25 years. There is no proven treatment for Alport syndrome, although studies in animals have     suggested several promising potential therapies. Potential drug treatments that might delay     or prevent the development of kidney failure exist, but need to be evaluated through clinical     trails. Conducting clinical trails for proposed treatments for Alport syndrome present many     challenges. Because Alport syndrome is not a common disease, informative clinical trials will     require the collaboration of investigators at multiple centers.      The University of Minnesota, Department of Pediatrics, proposes to create the Alport Syndrome     Treatments and Outcomes Registry (ASTOR) in order to facilitate clinical trials for the     treatment of Alport Syndrome. This registry will be the first of its kind in North America.     Because Alport syndrome is a rare disorder, recruitment of sufficient participants for     meaningful therapeutic trials will require a multicenter effort. The primary objective of     establishing and sustaining this registry is to enable clinical natural history studies and     therapeutic trials to be conducted in children and adolescents with Alport syndrome.   "
201702|NCT00481143|"     The purpose of this study is to investigate the effects of iron chelation using deferasirox     in low and INT-1 risk (referring to the international prognostic scoring system, IPSS) MDS     patients who show signs of iron overload due to repeated blood transfusions.      This trial is not recruiting patients in the United States.   "
201703|NCT00481156|"     The purpose of this study is to examine behavioral and functional brain changes occuring as a     result of cognitive remediation training in patients with schizophrenia. Extension and     specificity of related changes will also be examined.   "
201704|NCT00481169|"     The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an     investigational drug, is safe and effective in the prevention of osteoporosis in     postmenopausal women.   "
201705|NCT00481182|"     To assess the combined effects of fosamprenavir 700mg BID + ritonavir 100mg BID +     standardized dose of methadone, on plasma total and unbound methadone enantiomer     pharmacokinetics (PK), opiate pharmacodynamic (PD) measures, and safety. The effect of     methadone on plasma amprenavir PK will also be assessed by comparison to historical control     data.   "
201706|NCT00481195|"     The primary objective of the study is to determine if armodafinil treatment, at a dosage of     150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are     experiencing a major depressive episode associated with Bipolar I Disorder and who are     inadequately responsive to their current treatment for a current major depressive episode.   "
201707|NCT00481208|"     Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow may     have distinctive patterns in medically well-controlled open-angle glaucoma patients. In the     results, we found a unique pattern, 'Latent asymmetric IOP', defined as the IOP which differs     between the eyes only when placed in the supine position. Unique effects of this latent     asymmetric IOP on Visual field and diurnal IOP fluctuations were studied.   "
201708|NCT00481221|"     β thalassemia is an autosomal recessive hemoglobinopathy and considered as the most     widespread genetic mutation. According to the World Health Organization (WHO) between 1.5-7%     of the world population are carriers for this disease, and every year 60,000-400,000 birth of     new patients are reported. In Israel, the incidence of carriers for β thalassemia is around     20% among the Jewish from Kurdish origin and around 5-10% among the Arab population.      β thalassemia is a severe disease which requires many resources, both medical and financial.     The disease is expressed by chronic hemolytic anemia which requires regular blood     transfusions every 3 weeks. As a result of the blood transfusions and the iron absorption by     the digestive tract, those patients suffer from severe hemosiderosis which is the main     mortality cause in the disease, mainly in the second decade for life. Daily treatment with     iron chelator is required. Moreover, despite the actual treatment, the quality of life of     those patients is still low.      Therefore the implementation of a prevention program which includes finding an effective and     inexpensive way for identifying the β thalassemia carriers is a humanitary and publicly     important goal.      In β thalassemia carriers, laboratory tests will show hypochromic microcytic anemia. Those     findings are similar in iron deficiency anemia, but the RBC number and the RDW are normal in     thalassemia carriers.      Few researchers tried in the past to determine cutoff point for diagnosis of β thalassemia     carriers by different formulas.      We used the algorithm SVM (support vector machine) to find a reliable formula that can     separate patients with Iron deficiency anemia/ healthy from patients with β thalassemia minor     (carriers). This formula can be inserted to any automatic blood counter and search for     suspected carriers without deliberately intention and without any further blood test.   "
201709|NCT00481234|"     Patients with underlying cardiovascular disease are at high risk of perioperative     cardiovascular events and death. Hemodynamic variables are controlled by the autonomic     nervous system reflected by Heart Rate Variability. To investigate whether differences of HRV     parameters predict perioperative cardiovascular events.   "
201710|NCT00481247|"     The purpose of this clinical research study is to compare the confirmed complete cytogenetic     response of dasatinib with that of imatinib within 12 months after randomization in patients     with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety     of this treatment will also be studied.   "
201711|NCT00481260|"     Hgb C is an hemoglobinopathy quite rare in Israel. The clinical status of patients that are     diagnosed as homozygous to this disease is quite benign but not study in large groups.      Also the characteristics of carriers and the incidence in northern Israel were a large arab     population lives, was not study. The results of this study can be useful for screening     purpose in a area were another hemoglobinopathies are frequent.   "
201712|NCT00481273|"     This registry is a prospective, multi-center, observational study compiling data on the     natural history and management of patients receiving Vidaza, and will provide unique insights     into the management of myelodysplastic syndromes (MDS) and other hematological disorders and     the impact of these disorders on patients.   "
201713|NCT00481286|"     The purpose of this study is to determine if group clinics help older veterans change     behaviors with the goal of improving diabetes outcomes.   "
201714|NCT00481299|"     Prolactin is suggested to influence insulin resistance, but scarce data is available on the     metabolic profile of patients with prolactinoma.      The purpose of the protocol was to evaluate cardiovascular disease risk factors in women with     prolactinoma treated with dopamine agonists and to study the influence of disease control and     anthropometry on their metabolic profile.   "
201715|NCT00481312|"     Patients in ICU who need help with their breathing are put onto a machine called a ventilator     and are also given a medicine, called a sedative, which helps them to sleep and makes them     more comfortable. Midazolam is a sedative that is routinely used for these purposes.      For most patients the aim of sedation is to make them sleepy but still able to respond to     nursing staff (light sedation)      Dexmedetomidine is a new sedative for use in intensive care and in this clinical study,     dexmedetomidine is compared to midazolam. It is thought that dexmedetomidine might be     slightly better at allowing patients to be sleepy but still respond to people around them. It     also does not appear to affect patient's breathing. the purpose of this study is to test     whether dexmedetomidine really does have these advantages compared to midazolam.      in this study we hope to show that: dexmedetomidine is at least as good as midazolam in     helping patients to sleep better and making them more comfortable, and that they are able to     co-operate better with the staff treating them, and that patients treated with     dexmedetomidine require a shorter time on the ventilator than those treated with midazolam.   "
201716|NCT00481325|"     The purpose of this study is to learn about the safety and efficacy of pexacerfont in     outpatients diagnosed with Generalized Anxiety Disorder   "
201717|NCT00481338|"     The aim of the project is to assemble and to follow on a 10-year period a nationwide     representative sample of lower limb OA patients.      General objectives: To document the natural history and to identify predictive factors of the     evolution and consequences of hip and knee OA in terms of pain, functional disability,     structural damage, quality of life, autonomy, medical and health care use and cost of     disease.   "
201718|NCT00481351|"     Effects of statin and ezetimibe association on kinetics of artificial chylomicrons in men     with stable coronary heart disease (CHD).      Background:      The rate (kinetics) of chylomicrons removal from circulation have been correlated with the     incidence and severity of atherosclerotic lesions; a number of studies demonstrated lower     plasmatic clearance of chylomicrons in patients with CHD compared to patients without this     condition. It was also demonstrated a correlation among LDL-C levels and removal of     chylomicrons remnants by a technique employing artificial chylomicrons.      The investigators also know that higher doses of more potent statins are more effective in     chylomicrons removal than lower doses or less potent statins; nevertheless, the effect of the     isolated use of statin has not been completely studied up to now.      Study design:      The investigators propose to study 26 outpatients volunteers with chronic CHD, followed at     the Heart Institute - INCOR - of the School of Medicine, University of São Paulo.      Following a period of six weeks of washout from any cholesterol reducer, the kinetics of     chylomicrons removal by a technique of emulsion of radiolabeled artificial chylomicrons will     be evaluated. Lipid fractions, hepatic enzymes and CK will be measured. Initially patients     will be randomly allocated to receive simvastatin 20 mg /day (n= 13) or ezetimibe 10 mg/day     (n=13) for six weeks. At the end of this period, kinetics of chylomicrons removal and     laboratorial measurements will be repeated (Period 1).      In the next period (Period 2) patients will receive simvastatin 20 mg/ ezetimibe 10 mg (n=13)     or simvastatin 80 mg (n=13) for additional six weeks; at the end of this period, the     evaluations will be repeated (third and last evaluation).      The aim of this study is to further understand chylomicrons metabolism in patients with     chronic coronary disease receiving cholesterol reducers at different dosage regimes.   "
201719|NCT00481364|"     This prospective, randomized, controlled study aims to investigate the effects of     atorvastatin treatment in hemodialysis patients concerning progression of coronary artery     calcification, progression of carotid artery intima-media thickness, endothelial function,     and inflammation.   "
201720|NCT00481377|"     The aim of this study is to assess the role of ablation in appropriate ICD interventions     reduction in patients with coronary artery disease. The group will consist of 200 patients     with implanted ICD and appropriate intervention in the 3 months prior to enrollment. The     patients will be randomized into ablation arm and conventional treatment. Number of     appropriate ICD interventions is the primary endpoint of this study. All patients will have     control follow-up visits every 3 months. The follow-up will be based on ICD memory.   "
201721|NCT00481390|"     This study is a cross-sectional observational study to evaluate the prevalence of HLA-B*5701     in the European area and in major European ethnotypes.      Any HIV-1 infected patient will be eligible for this study including treatment naïve and     experienced patients, as well as patients previously tested for HLA-B*5701. Patients will be     approached during a standard clinic visit, and will be consented prior to any study specific     procedure. They will be asked to provide a tissue sample (cheek cells and blood sample) which     will be used to assess HLA-B*5701 status by local and central laboratories.      In selected sites patients may be asked to provide an additional blood sample. This sample     will be used to develop and validate different methodologies for assessing HLA-B*5701 status.   "
201722|NCT00481403|"     Sperm analysis following World Health Organization guidelines is unable to explain the     molecular causes of male infertility when basic sperm parameters are within a normal range     and women do not present gynaecological pathology.      Subsequently, there is a need for accurate diagnostic tools in this sense and microarray     technology applied to sperm analysis emerges as a promising field   "
201723|NCT00481416|"     The purpose of the study is to access the accuracy of the PillCam Eso capsule in identifying     the presence of suspected esophageal disease in patients undergoing surveillance or screening     for esophageal disease by standard endoscopy   "
201724|NCT00481429|"     Hypothesis:      A cluster of biochemical measurements (biomarkers) predict which diabetic patients will     respond to treatment with a therapeutic dose of rosiglitazone over a 12 week treatment     period.      Brief Summary:      The purpose of this study is to assess the predictive value of the biomarkers in diabetic     patients treated with a full dose of a thiazolidinedione (eg 4mg bid rosiglitazone) for 12     weeks.      Specifically - the questions asked are:        1. Do baseline measurements of a selected panel of biomarkers predict the patients'          response to rosiglitazone over 12 weeks?        2. How does the panel of biomarkers change over that 12 week treatment period?   "
201725|NCT00481442|"     Clinical studies evaluating the clinical use of phenylephrine in septic shock are lacking.     The present study was designed to compare the effects of norepinephrine and phenylephrine on     systemic and regional hemodynamics in patients with catecholamine-dependent septic shock.   "
201726|NCT00481455|"     The purpose of this study is to evaluate the anti-tumor activity and safety of Panzem NCD     given in combination with daily oral fixed-dose temozolomide in patients with recurrent     glioblastoma multiforme.   "
201728|NCT00481481|"     Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based     immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin     based immunosuppressive regimen.   "
201729|NCT00481494|"     Personality traits may influence to the drug compliance in glaucoma patients.   "
201730|NCT00481507|"     The purpose of this study is to determine the effectiveness of commercially available kefir     on preventing antibiotic-associated diarrhea compared to placebo in children ages 1-5.   "
201732|NCT00481533|"     Despite of marked improvements in clinical management, early postpartum     hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in     developing countries and in hospitals equipped with all that modern medicine has to offer.     This complication is amongst the most challenging that a clinician will face in the obstetric     patient. Prevention, early recognition and prompt appropriate intervention are the keys to     minimizing the impact of PPH on women’s health.      Patients undergoing Cesarean sections following failure to progress in labor are at great     risk for PPH and should theoretically benefit from an additional uterotonic agent. This study     will be conducted to define whether the addition of ergonovine maleate to oxytocin,     administered in a prophylactic way, reduces blood loss during Cesarean section for failure to     progress in labor.   "
201733|NCT00481546|"     A recombinant adeno-associated virus serotype 2 (rAAV2) vector has been altered to carry the     human RPE65 (hRPE65) gene. This vector has been shown to restore vision in animal models that     resemble human RPE65-associated Leber congenital amaurosis (LCA), an incurable retinal     degeneration that causes severe vision loss. The proposed study is an open label, Phase I     clinical trial of subretinal rAAV2-CBSB-hRPE65 administration to individuals with     RPE65-associated retinal disease. Five cohorts will be included in this trial. Cohorts 1, 2     and 4 will consist of individuals 18 years of age and older. Cohorts 3 and 5 will consist of     individuals between the ages of 8 and 17, inclusive. Enrollment in Cohorts 3 and 5 will begin     only after confirming the safety of rAAV2-CBSB-hRPE65 administration in the older groups of     participants. This trial will lead to a greater understanding of the safety and thereby     potential value of gene transfer in RPE65-associated retinal disease and will have     implications for other forms of retinal degenerative disease amenable to this type of     intervention.      The goal of this clinical trial is to determine the safety of uniocular subretinal     administration of rAAV2-CBSB-hRPE65 in individuals with RPE65-associated retinal disease.     Ocular and systemic toxicity will be assessed prior to and following vector administration to     determine if there are adverse changes that may be associated with vector administration.   "
201734|NCT00481559|"     This protocol is for the treatment of toxic plasma methotrexate concentrations (>1 micromole     per liter) in patients with delayed methotrexate clearance due to impaired renal function   "
201735|NCT00481572|"     The purpose of this study is to determine whether: A)the continuous infusion ultra-low dose     of terlipressin (1.3 micrograms/kg/h) is able to stabilize hemodynamic in patients with     septic shock, reducing the risk of adverse effects related to the bolus dose.B)the continuous     infusion ultra-low dose of terlipressin may be use in lieu of vasopressin.   "
201736|NCT00481585|"     The objective of the present study is to determine whether or not primary human mammary     epithelial cells are competent for use in molecular studies of transepithelial     electrophysiology focusing on the function of the tight junction protein claudin 3.      Human breast Tissue will be removed from mastectomy specimens and used as a source to     generate epithelial cells for study.   "
201737|NCT00481598|"     Patients with Type 1 diabetes (T1DM) suffer from impaired postprandial hepatic glycogen     storage and breakdown, if they are under poor glycaemic control. Poor glycogen storage in the     liver puts these patients at risk of fasting hypoglycaemia. Amelioration of glycaemic control     could improve these abnormalities and thereby reduce the risk of hypoglycaemia in these     patients. The gold standard technique for the assessment of hepatic glycogen metabolism in     humans, 13 C magnetic resonance spectroscopy (13C-MRS), is expensive and limited to a few     centers worldwide. Furthermore, treated type 1 diabetic patients exhibit skeletal muscle     insulin resistance when treated insufficiently. This condition can also be reversed by     improvement of glycaemic control. Recent studies link skeletal muscle insulin resistance to     impaired mitochondrial function. Up to date, the impact of glycaemic control on skeletal     muscle mitochondrial function has not yet been assessed.      Aim 1 of our project is to establish a new assessment method for glycogen metabolism. This     new method is based on oral administration of 2H2O and acetaminophen.      Our second aim is to examine the impact of improvements of glycaemic control on skeletal     muscle mitochondrial function in type 1 diabetic patients.      Our third aim is to assess the ATP-synthesis in T1DM.      We will conduct a prospective study on 14 patients with type 1 diabetes and 14 healthy     controls.      On the respective study day, participants will be served three standardized meals, blood     sugar will be controlled hourly and blood samples will be drawn at timed intervals to     determine glucoregulatory hormones, metabolites and enrichments of [6,6-2H2]glucose.      During the night, four 13C-MRS-measurements will be performed in combination with     [6,6-2H2]glucose infusion to assess glucose production, glycogen breakdown and     gluconeogenesis.      In addition, patients will drink 3g/kg bodyweight 2H2O and acetaminophen will be     administered. Thus the new 2H2O-acetaminophen method will be applied simultaneously with the     gold standard method.      The following morning, mitochondrial function will be assessed in skeletal muscle from     unidirectional flux through ATP synthase by 31P MRS.      TIDM patients will be studied twice. First, under conditions of insufficient glycaemic     control and the second time after three months of intensified insulin treatment using CSII     pumps aiming at optimized metabolic control. Healthy controls will be studied only once.      To assess muscular mitochondrial function in T1DM we will measure ATP synthesis in a calf     muscle with magnetic resonance spectroscopy. First, we will conduct a basal measurement.     Thereafter, we will start a hyperinsulinaemic euglycemic calmp to stimulate the ATP synthesis     and measure again.      This study will provide information on rates of post absorptive glycogen breakdown,     gluconeogenesis, and postprandial glycogen storage in the liver and on the skeletal muscle     mitochondrial function under conditions of optimized glycaemic control for 3 months.      Finally, this study will demonstrate whether or not poorly controlled type 1 diabetic     patients exhibit abnormalities in muscle mitochondrial function and to what extent those     alterations can be reversed by optimized glycaemic control. We expect to validate the     2H2O-acetaminophen method, which will provide justification for a broad scale in clinical     studies.   "
201738|NCT00481611|"     Background:        -  Trichloroethylene (TCE) is a solvent used in many medical and industrial processes.        -  TCE is a carcinogen (causes cancer) in rats, but its carcinogenicity in humans is          unclear. There is some evidence of increased liver and kidney cancers and of an          association with non-Hodgkin lymphoma in studies of workers exposed to TCE.        -  The carcinogenicity and regulation of TCE is a matter of continuing debate.      Objectives:        -  To determine if TCE exposure is associated with higher levels of genetic aberrations in          certain white blood cells called lymphocytes.        -  To determine if TCE exposure affects lymphocyte subsets and levels of certain hormones          called cytokines.      Eligibility: Workers exposed to two different levels of exposure to TCE and unexposed workers     in Guangdong Province, China.      Design:        -  45 workers exposed to more than 25 parts per million (ppm) TCE, 30 workers exposed to          from 10 to less than 25 ppm TCE and 45 unexposed workers will be enrolled.        -  Subjects wear small instruments at work that measure chemicals in the air for 1 or 2          days during the 2-week study period. Exposed workers also wear several small skin          patches on one of the two days.        -  Subjects provide blood and urine samples.        -  Subjects answer a questionnaire about work, smoking and drinking, use of medicines,          medical history, general health, hobbies, and exposure to radiation and exposure to          various substances at home.   "
201739|NCT00481624|"     The purpose of this study is to find a better, more convenient way to improve anemia results     by increasing the amount of medication given at 3 week intervals. Researchers want to know if     giving a higher dose of Procrit® and intravenous (IV) iron once every 3 weeks would give     better results in treating anemia without the need for more office visits.   "
201741|NCT00481650|"     A prospective, observational study (Anwendungsbeobachtung [AWB]) of the prescribing and     administration practices of German gynecologists with Leios® Dragées.   "
201744|NCT00481689|"     Researchers want to find out if a drug called Cipro® XR (ciprofloxacin extended-release) can     help people with a complicated urinary tract infection caused by a kind of bacteria called     Pseudomonas aeruginosa. The study doctor will give Cipro XR to some people to see if it is     safe and works to treat complicated urinary tract infections caused by Pseudomonas     aeruginosa. The study doctor will also gather information about using Cipro XR to treat     complicated urinary tract infections caused by other bacteria. About 500 people with     complicated urinary tract infections who are 18 years old and older will join this study.     Cipro XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of     complicated urinary tract infections and acute uncomplicated pyelonephritis (inflammation of     the kidney). The dose of Cipro XR used in this study (1000 mg a day for 7 to 14 days), has     been shown to be safe and effective. This study is being done to gather more information on     using this dose of Cipro XR for complicated urinary tract infections caused by Pseudomonas     aeruginosa, as well as by other bacteria.   "
201745|NCT00481702|"     A multicenter study to evaluate the effectiveness of ertapenem compared to     ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in     adult patients.   "
201746|NCT00481715|"     Obesity has reached epidemic proportions in the United States with nearly 64% of American     adults considered overweight or obese. Weight loss programs that take place at work have     proven to be effective at promoting healthy lifestyles. The purpose of this study is to     compare the effectiveness of a Web-based weight loss program versus a cash incentive weight     loss program among employees at North Carolina universities and colleges.   "
201747|NCT00481728|"     Measuring sympathetic skin response or heart rate variability can provide an objective     biomarker of bladder sensation and its modulation by drug with potential to treat overactive     bladder.   "
201748|NCT00481741|"     We seek to determine if the use of the SafeSeal(TM) topical hemostasis patch is associated     with reductions in time to hemostasis and time to ambulation compared to standard manual     compression after arterial sheath removal following percutaneous coronary and peripheral     intervention. We further seek to assess the safety of the SafeSeal patch compared to manual     compression.   "
201749|NCT00481754|"     Background:        -  Endometrial cancer (cancer of the lining of the uterus) is the most common gynecologic          cancer in the United States.        -  Currently, there are no markers (components of blood and tissue that determine who might          be at risk for developing cancer) for endometrial cancer.      Objectives:      -To see if women who are undergoing hysterectomy are willing to provide blood and tissue     samples to help doctors identify markers that would indicate increased risk for developing     endometrial cancer.      Eligibility:      -Women between 35 and 54 years of age who will undergo hysterectomy for a non-cancerous     condition, such as uterine fibroids, uterine prolapse, abnormal uterine bleeding, and others     at Magee-Women's Hospital in Pittsburgh, Penn.      Design:        -  Patients' medical records are reviewed and patients complete a questionnaire including          information on race and ethnic background, education, marital status, family history,          height, weight, pregnancy history, smoking history, medication history, history about          menstrual periods and menopausal symptoms.        -  Patients provide blood and urine samples before surgery.        -  A sample of fat tissue is removed during surgery in patients undergoing abdominal          surgery.        -  Tissue samples from the removed uterus (and ovaries if the ovaries are also removed) are          collected and analyzed for markers for endometrial cancer.   "
201750|NCT00481767|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. The current study is designed to assess the immunogenicity and safety of     GlaxoSmithKline Biologicals' HPV vaccine 580299 in female subjects aged 10-25 years enrolled     in Africa.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
201751|NCT00481780|"     Percutaneous transluminal angioplasty (PTA) is a minimally invasive technique for treatment     of superficial femoropopliteal artery (SFA) obstructions or occlusions in patients with     intermittent claudication as well as critical limb ischemia. Initial technical success rates     of above 95% can be achieved and acceptably low rates of complications are consistently     reported in the literature. There is a direct relation between treated vessel length and     patency rates. One year patency of lesions longer than 10cm has only been 22% at one-year     follow up. This major drawback limits a widespread applicability of PTA, and the indication     of PTA particularly in patients with intermittent claudication is discussed     controversially.With the introduction of endovascular stents, the problems of elastic recoil     and residual stenoses due to arterial dissection could be resolved and initial reports of     stenting for the treatment of occlusive atherosclerotic disease of the SFA showed promising     results with primary and secondary patency rates of 87% to 90% after 18 months. However,     subsequent studies demonstrated that exaggerated neo-intimal hyperplasia in the stented     segment frequently leads to instent restenosis. This condition will be of greater importance     with increasing number of stent implantation procedures during the last years. The concept of     cutting balloon seems appealing for this indication, as the balloon-mounted microtomes     guarantee smooth lumen gain within the stent, without the risk of vessel wall perforation.     Initial reports of the use of the cutting balloon for the treatment of occlusive     atherosclerotic disease of the SFA show promising results, indicating that the problems of     elastic recoil and residual stenoses due to arterial dissection might be resolved. The     cutting balloon has four tiny microtomes (< 0.1mm height) on the outside, which cut the     fibrous plaque during expansion of the balloon. Consequently the problem of elastic recoil is     ideally addressed, additionally less trauma is exercised on the vessel wall during dilatation     of the balloon. This might be achieved by a reduction of vessel wall trauma, vessel wall     inflammation and consequently reduced neointimal formation. Although the indications for     CB-PTA in the SFA includes significant residual stenosis or in-stent restenosis, there are     currently no published randomized controlled trials (RCT) comparing PTA vs. cutting balloon     angioplasty (CB-PTA) for any specific condition. This lack of data led us to initiate a RCT     comparing primary PTA vs. CB-PTA for treatment of in-stent restenoses in patients with     intermittent claudication or critical limb ischemia with TASC category A-B in the     femoropopliteal artery .   "
201764|NCT00481962|"     The main goals of the study are: Assessment of Tygacil's cost-effectiveness; Process cost     analysis from a hospital perspective (including length of stay, treatment costs, side effect     management costs, costs of monitoring, costs of diagnostic procedures, cost of care (TISS 10     score etc.); Efficacy of Tygacil under usual care conditions (cure rate).   "
201921|NCT00490659|"     The purpose of this study is to test feasibility, toxicity and efficacy of two different     adjuvant treatment schedules in Stage II-IIIa Non-small cell lung cancer patients with     positive lymph nodes.   "
201765|NCT00481975|"     The primary objective is to assess the effect of rimonabant compared to placebo on weight     loss over a period of 6 months when prescribed with a mild hypocaloric diet in obese patients     with binge eating disorder.      The secondary objectives are:        -  to assess the effect of rimonabant on the number of binge episodes per week, to assess          the effect of rimonabant on eating behavior using the Binge Eating Scale (BES) and Three          Factor Eating Questionnaire (TFEQ),        -  to evaluate the safety and tolerability of rimonabant over a period of 6 months.   "
201752|NCT00481793|"     This is a collaborative study by the National Cancer Institute, Columbia University, and the     Southern Urals Biophysics Institute in Russia. It will examine the relationship of     differences in certain genes to the development of chromosomal abnormalities in workers at     the Mayak nuclear production plant in Ozyorsk, Russia. This population was exposed to higher     radiation doses from external and internal sources than those received by their counterparts     in other countries or considered permissible today. If a risk relationship is found between     genetic differences and chromosome abnormalities, the information might be useful in studies     designed to examine how high radiation exposures cause cancer.      Radiation-exposed Mayak workers employed from 1948 to 1972 in the three Ozyorsk plants     directly related to nuclear weapons production may be eligible for this study. They must have     remained local residents in the area and estimates of their external and internal radiation     exposures must be available.      Participants provide a blood sample for genetic studies and answer a questionnaire that     includes demographic information and information about their family health history, history     of benign tumors, if any, and history of smoking and alcohol consumption. Additional     information is collected from patients' medical records.   "
201753|NCT00481806|"     Heart bypass surgery, also known as coronary artery bypass graft (CABG) surgery, creates a     detour around the blocked part of a heart artery to restore blood supply to the heart muscle.     The saphenous vein, located along the inside of the leg, is commonly used to create the     bypass in a CABG surgery. An abnormal increase in the blood clotting protein thrombin may     cause the saphenous vein graft to close up and eventually fail. This study will evaluate the     relationship between thrombin levels and saphenous vein graft failures in people undergoing a     CABG procedure.   "
201754|NCT00481819|"     The patients about to undergo kidney transplantation will be randomized to one of the     following two group:      Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment     period is 3 months( 12 weeks)   "
201755|NCT00481832|"     The purpose of this trial is to develop an alternative treatment for patients with poor risk     non-Hodgkin's lymphoma. This trial uses a combination of high dose chemotherapy with stem     cell transplant using the patient's own cells. This is followed with non-myeloablative     transplant using stem cells from a related or unrelated donor to try and generate an     anti-lymphoma response from the new immune system.   "
201756|NCT00481845|"     In this study we plan to study the combination of ZD6474, a dual inhibitor of EGFR and     VEGFR-2 with anastrozole in the neoadjuvant setting for patients with Stage I-III breast     cancer. The aim is to overcome mechanisms of resistance and simultaneously block multiple     critical signaling pathways known to stimulate breast cancer.   "
201757|NCT00481858|"     This project will attempt to validate the utilization of a stable isotope kinetic biomarker     (KineMarkerTM) as a predictive test for disease progression in early stage chronic     lymphocytic leukemia (CLL).   "
201758|NCT00481871|"     This study is for patients with lymphoproliferative malignancies that have progressed after     receiving a previous treatment (relapsed) or are no longer responding to treatment     (refractory). To be in this study, patients must have certain types of Hodgkin's lymphoma     (HL), peripheral T-cell lymphoma (PTCL), or B-cell lymphoma, including Waldenstrom's     macroglobulinemia.      This study is being done to find doses of the combination of pralatrexate and gemcitabine     with vitamin B12 and folic acid that can be safely given to patients with these types of     lymphoma and explore the effectiveness of the treatment.   "
201759|NCT00481884|"     Primary Objective:      To determine if RadiaPlexRx Hydrogel can reduce the development of grade 2 or higher     radiation dermatitis in breast cancer from adjuvant radiation when compared to a     petroleum-based gel (Aquaphor) commonly used as best supportive care.   "
201760|NCT00481897|"     The Worksite Nutrition Study is 22-week translational study aimed at determining how well a     worksite-based nutrition program, as compared to a control group, is able to 1) produce     clinically significant weight-loss, 2) improve cardiovascular factors, 3) decrease work     absenteeism, 4) improve overall quality of life, 5) improve diabetes control in participants     with diabetes, and 6) promote dietary adherence and acceptability. The nutrition program for     the intervention group consists of once-weekly group meetings where participants will receive     group support and nutrition education on a low-fat, vegan diet.   "
201761|NCT00481923|"     The primary objective of this study is to assess the effect of rimonabant on the energy     intake (kcal/day/meal) from ad-libitum high-fat dinner (primary endpoint), pre- and     post-ingestive responses, and the hedonic evaluation of food, and its effect on food choice,     cravings and feelings of control.      The secondary objectives are to determine the effect of rimonabant on body weight with or     without hypocaloric diet and its clinical and laboratory safety.   "
201762|NCT00481936|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of VB6-845 and to     evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV     infusion to patients with advanced solid tumour of epithelial origin.   "
201763|NCT00481949|"     Monitoring oesophageal pH provides a definitive diagnosis of patients with gastro-oesophageal     reflux disease (GORD), especially those in whom the association between reflux and symptoms     is uncertain and those under consideration for anti-reflux surgery. Standard ambulatory     investigation is normally performed by naso-oesophageal catheter however this is associated     with considerable discomfort and in turn altered behaviour which reduces reflux provoking     activities. Furthermore results of catheter based ambulatory pH studies are compromised by     the high variability of acid exposure in patients with suspected GORD.      Prolonging pH measurements by the catheter-free Bravo™ system from 24 to 48 and 96hrs     significantly improves the consistency (reliability) and reproducibility of diagnoses based     on oesophageal acid exposure, as well as the ability to associate acid reflux to symptom     episodes. This improves diagnosis especially in those with intermittent symptoms.      However pH monitoring does not provide a direct assessment of the underlying pathophysiology.     Incompetence of the oesophago-gastric junction (OGJ) related to disruption of its structure     and function is considered to be the most important cause of GORD. A more relevant assessment     of the reflux barrier may be its distensibility (i.e. the ease with which the OGJ is opened     to allow retrograde passage of gastric contents); however this is not assessed by current     clinical investigations.      Endo-FLIP (Crospon Medical Devices) is a new tool which assesses OGJ structure and function,     and appears to provide relevant information regarding its distensibility and competence.      This study applies to using Endo-Flip to record OGJ distensibility and Bravo to record acid     exposure and symptom association in patients with reflux symptoms. The variability of pH     measurements and symptoms and diagnostic accuracy will be assessed over 96hrs. Endo-FLIP     results will then be compared against Bravo. The outcome of post investigation therapy will     then be compared with Endo-Flip and Bravo results to assess if baseline testing can predict     the outcome of acid suppression therapy.      Study Hypothesis        1. There is a positive, continuous association between OGJ distensibility measured by          Endo-FLIP on % acid exposure assessed by prolonged Bravo pH monitoring        2. The results of Endo-FLIP and prolonged Bravo predict treatment outcome of a trial of          proton pump inhibitor therapy   "
201840|NCT00482989|"     To evaluate the safety and tolerability of multiple IV doses of the MEDIMUNNE antibody in     adult patients with SLE.   "
201770|NCT00482040|"     The purpose of this study is to evaluate four different nasal continuous pressure systems,     which are usually applied on our neonatal intensive care unit, with regard of their effect on     bradycardia and desaturations in preterm infants.   "
201771|NCT00482053|"     The purpose of this study is to develop an alternative treatment for patients with relapsed     diffuse large B cell lymphoma who are not likely to be cured by the conventional     transplantation regimen.   "
201772|NCT00482066|"     The purpose of this study is to investigate whether abatacept can prevent relapse in patients     with ANCA associated vasculitis(AAV). This is a randomised double blinded placebo controlled     trial.   "
201773|NCT00482079|"     A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control     of their blood sugar.   "
201774|NCT00482092|"     Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant     to, or have previously failed therapy with, at least one steroid and at least one     immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The     protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to     induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks,     for approximately an hour each time.   "
201775|NCT00482105|"     This study is divided into distinct sample collection and analysis phases. In the sample     collection phase investigators will tape strip lesions that are designated for biopsy because     they are suspected for melanoma. No biopsies will be taken solely in support of this study;     rather patients that present lesions that are to be biopsied—in the context of the standard     of care—will be enrolled in the study and will have that lesion(s) tape stripped before the     biopsy procedure.      In the second phase of the study, tape strip samples will be extracted and RNA purified and     expression profiled by DNA microarray. The gene expression data will be correlated with     histopathology with the expectation that an expression classifier that distinguishes suspect     lesions from melanoma can be defined. That classifier will be validated in future studies.   "
201776|NCT00482118|"     Background:        -  Women in Xuan Wei County, China, are almost all non-smokers, yet they have the highest          lung cancer rate in that country.        -  Non-smoking women in Xuan Wei who use smoky coal for cooking and heating homes can          inhale 10 times higher levels of polycyclic aromatic hydrocarbons (PAH, compounds formed          in many burning organic substances, including smoky coal) than someone who smokes 20          cigarettes a day.      Objectives:        -  Determine the health effects of smoky coal in Xuan Wei and Fu Yuan counties in China's          Yun Nan Province        -  Determine how different levels of exposure to smoky coal and other types of fuel affect          the amount of smoky coal emissions that are absorbed into the body        -  Determine genetic risk factors for lung cancer in the study population and determine how          they interact with smoky coal and PAH exposure.      Eligibility:        -  Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who have lung          cancer and do or do not use smoky coal        -  Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who do not have          lung cancer and do or do not use smoky coal      Design:      -Exposure assessment study for users of smoky coal - 150 households      Use of air badges, monitors, and dermal badges to determine subjects' exposure to smoky coal      Collection of blood, urine, cheek cell and sputum samples to measure the amount of smoky coal     emissions absorbed into the body and evaluate the types of biologic changes they cause      Interview subjects about their health and family history, occupational exposures, lifestyle     factors (e.g., tobacco smoking and diet), and inherited differences in genes      -Case-control study - 1,000 women      Collection of blood, urine, cheek cell and sputum samples to measure how amount of smoky coal     emissions absorbed into the body and evaluate types of biologic changes they cause      Interview subjects about their health and family history, occupational exposures, lifestyle     factors (e.g., tobacco smoking and diet), and inherited differences in genes      Gene analysis to determine if a genetic variation is associated with an increased or     decreased risk of health effects from smoky coal exposure   "
201777|NCT00482144|"     The purpose of this study is to compare the effects of the pulsed-dye laser (PDL) at two     different wavelengths, 585nm and 595nm, in the treatment of post-surgical scars starting on     suture-removal day.   "
201778|NCT00482157|"     After the diagnosis of prostate cancer, many men alter their lifestyle or diet or use various     supplements in an attempt to retard the growth of their cancer. While there is limited data     on the use of diet and supplements to alter the risk of prostate cancer, even less is known     regarding the ability of diet or supplements to alter progression. For men who have elected     active surveillance, the investigators propose to investigate the ability of vitamin D to     retard the growth of prostate cancer.   "
201779|NCT00482170|"     Primary objective of this study is to compare patient satisfaction with the prefilled syringe     (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12     weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary     evaluation focus on the identification of patient and device attributes associated with     patient satisfaction.   "
201780|NCT00482183|"     Drug-eluting stents have been shown to decrease restenosis, but were associated with an     increased rate of death, as compared with bare-metal stents. Recently, thiazolidinediones     effectively reduced restenosis and the risk of repeat target vessel revascularization. We     conducted a study to compare the performance of a drug-eluting stent with that of a     bare-metal stent with pioglitazone in patients with type 2 diabetic mellitus.   "
201781|NCT00482196|"     To study different doses of MK0493 for safety, efficacy and tolerability in obese patients.   "
201782|NCT00482209|"     This double-blind, randomized study will compare the efficacy and acceptability of     mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e.,     in the cheeks) for termination of pregnancy in women up to 63 days LMP.   "
201841|NCT00483002|"     To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg     medication for 12 weeks in smokers   "
201783|NCT00482222|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and     capecitabine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving     combination chemotherapy together with monoclonal antibodies before surgery may make the     tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these     treatments after surgery may kill any tumor cells that remain after surgery. It is not yet     known whether combination chemotherapy is more effective with or without cetuximab in     treating liver metastases caused by colorectal cancer.      PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how     well it works when given with or without cetuximab before and after surgery in treating     patients with resectable liver metastases caused by colorectal cancer.   "
201784|NCT00482235|"     A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to     salmeterol and placebo.   "
201785|NCT00482248|"     This study will assess further the safety and tolerability of long-term treatment with     omalizumab by extending omalizumab treatment by 1 year for those patients with allergic     asthma who successfully completed study CIGE25011E2.   "
201786|NCT00482261|"     The purpose of this study is to see whether combination of low dose lenalidomide(10mg)+     dexamethasone is equally effective in treating relapsed/refractory myeloma in the group of     elderly patients and other patients at risk of myelosuppression, whilst producing less side     effects, especially myelosuppression compared to the higher dose of lenalidomide of 25mg used     in the MM-009 and MM-010 trials.   "
201787|NCT00482274|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with     relapsed prostate cancer.   "
201788|NCT00482287|"     The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic     effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population     of cardiac surgery patients.   "
201789|NCT00482300|"     The purpose of this trial is to determine whether the addition of systematic pelvic     lymphadenectomy to hysterectomy with bilateral adnexectomy improves disease-free survival     (DFS) and overall survival (OS) in patients with preoperatively supposed Stage I-II     endometrial cancer   "
201790|NCT00482313|"     The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in     treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.   "
201791|NCT00482339|"     Using methods of molecular biology bacteria can be detected in blood. In comparison to     conventional blood cultures bacterial DNA is isolated using a new sample preparation system     in platelet apheresis concentrates and in the predonation whole blood of donors.   "
201792|NCT00482352|"     This clinical trial is studying risk-group classification of patients with newly diagnosed     acute lymphoblastic leukemia. Developing a risk-group classification guide may help doctors     assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical     trials.   "
201793|NCT00482365|"     RATIONALE: Gathering health information about patients with liver cancer over time may help     doctors learn more about the disease and may help the study of cancer in the future.      PURPOSE: This clinical trial is developing a national registry and blood bank of patients     with liver cancer.   "
201794|NCT00482378|"     RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry     radiation directly to cancer cells and not harm normal cells. Zoledronic acid and pamidronate     may help relieve bone pain caused by multiple myeloma. Giving samarium Sm 153 lexidronam     pentasodium together with zoledronic acid or pamidronate may be an effective treatment for     multiple myeloma.      PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153     lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how     well it works in treating patients with relapsed or refractory multiple myeloma and bone     pain.   "
201795|NCT00482391|"     The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer.   "
201796|NCT00482404|"     This trial tests the hypothesis that increasing nonverbal affection in romantic relationships     will improve blood lipid parameters (total cholesterol, high and low density lipoproteins,     triglycerides), blood glucose, and immune parameters (C-reactive protein and antibodies to     latent Epstein-Barr virus). 52 healthy cohabiting romantic couples took part. In half of the     couples, one partner increased the frequency of romantic kissing with the other partner     during the six-week trial. The other couples received no such instruction. Blood tests     performed before and after the trial were used to assess the health outcomes.   "
201797|NCT00482417|"     Efficacy and Safety Study of MK0359 in Patients with Arthritis   "
201798|NCT00482430|"     The purpose of this study is to determine the safety and effectiveness of an investigational     drug for the treatment of cognitive impairment in patients with schizophrenia.   "
201799|NCT00482443|"     For people with Type 1 Diabetes, blood glucose control is achieved by matching insulin doses     directly to the amount of carbohydrate consumed. We are looking at new ways to help our     patients with type 1 diabetes manage their diabetes control more effectively. We are testing     if Diabetes Interactive Diary (DID), a novel programme designed to be used on a mobile     phone, can represent an important tool in carbohydrate counting while avoiding the use of     complex calculations and in depth knowledge about the carbohydrate content of their food.   "
201800|NCT00482456|"     Our study looks at the interaction of a common mutation in the MTHFR gene and the risk of     developing higher homocysteine levels after nitrous oxide (N2O) anesthesia.      Specifically, we want to test the hypothesis that healthy patients carrying the MTHFR 677C>T     haplotype develop abnormal homocysteine levels after nitrous oxide anesthesia.   "
201801|NCT00482469|"     It is our goal to study the mechanism of ischemia-reperfusion injury. Our DIEP-operation is     actually a clinical model of ischemia-reperfusion. Ischemia-reperfusion injury has never been     directly studied in a human, clinical model of autologous transplant.   "
201802|NCT00482482|"     Major depression, chronic depression and bipolar depression are complex and difficult     disorders to treat. They are often associated with residual symptoms with significant     functional impairment. Yoga has been shown to be beneficial in treating depressive symptoms     but without the added risks associated with medication use and has the advantage of high     consumer appeal (with likelihood of good compliance). However, it has only been tested in     unipolar depression, thus far. Yoga if shown to be effective (as an adjunctive to     pharmacotherapy) in improving residual symptoms and decreasing risk of relapse, would be of     significant long-term benefit to patients not only with major and chronic depression, but     also for those with bipolar disorder.      The aim of the study is to determine the safety and effectiveness of Yoga as an augmentation     treatment to pharmacotherapy and in comparison to psychoeducation, in improving residual     symptoms of depression over 16 weeks and in prevention of relapse/recurrence of mood episodes     over 1 year, in subjects with unipolar and bipolar disorders.   "
201803|NCT00482495|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the     growth of multiple myeloma by blocking blood flow to the cancer.      PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with     relapsed or refractory multiple myeloma.   "
201804|NCT00482508|"     This study will assess the safety and tolerability of long-term treatment with omalizumab     plus current asthma therapy in patients who participated in and successfully completed the     treatment period of study CIGE025IA04E1. Patients who participated in CIGE025IA04E1 were     perceived by both the patient and the investigator to have benefited from receiving treatment     with omalizumab plus current asthma therapy according to best medical practice   "
201805|NCT00482521|"     RATIONALE: CC-4047 may stop the growth of tumor cells by blocking blood flow to the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of CC-4047 in treating     patients with advanced solid tumors that did not respond to treatment.   "
201806|NCT00482547|"     Urinary catheters are often needed in hospital patients, but their use can increase the     chance that a catheter associated urinary tract infection (called a CAUTI) may occur. This     study will try to determine if patients who get a new silver coated catheter will have slower     to time to development of a CAUTI compared to patients who get an uncoated catheter.   "
201807|NCT00482560|"     The purpose of this study is to compare the antinociceptive effect of 1 ml of 30% sucrose     solution vs breastfeeding on neonatal screening heel lance   "
201808|NCT00482573|"     The hemodynamic parameters of 31 pregnant women with rheumatic valve disease, undergoing     restorative dentistry under local anesthesia with 2% solution of lidocaine, divided in two     groups, with (Group LE) and without 1:100,000 epinephrine solution (Group LNE), were studied     by 24-hour ambulatory electrocardiographic monitoring, intermittent blood pressure monitoring     and continuous cardiotocography, during three standard time periods. A significant decrease     in the values of maternal heart rate was seen during the procedure, in comparison with the     other two time periods in the two groups, as well as, the occurrence of cardiac arrhythmia in     9 (29.1%) patients, being 7 (41.8%) of them in the group receiving epinephrine anesthesia. We     conclude the use of 2% lidocaine in association with epinephrine proved safe during dental     procedure in pregnant women with rheumatic valve disease.   "
201809|NCT00482586|"     RATIONALE: Gathering information about quality of life over time from patients with liver     cancer treated with image-guided therapy may help the study of cancer in the future.      PURPOSE: This clinical trial is gathering information about quality of life over time from     patients with liver cancer treated with image-guided therapy.   "
201810|NCT00482599|"     The purpose of this study is to compare the efficacy and pharmacokinetics of Org 25969 in     subjects with normal or impaired renal function and to evaluate the safety of Org 25969 in     subjects with impaired renal function.   "
201811|NCT00482612|"     The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and     effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean     Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.   "
201812|NCT00482625|"     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed. This phase II trial     is studying how well erlotinib hydrochloride works in treating patients with pancreatic     cancer that can be removed by surgery   "
201813|NCT00482638|"     To assess the effect of MK0493 on body weight, blood pressure, mood, and appetite.   "
201814|NCT00482651|"     Atherosclerosis is a chronic and multifocal immunoinflammatory, fibroproliferative disease of     medium-sized and large arteries driven by lipid. Atherosclerosis is rarely fatal unless     thrombosis supervene, causing an acute coronary syndrome. Therefore, for event-free survival,     the vital question is not why atherosclerosis develops but rather why atherosclerosis, after     years after indolent growth, suddenly becomes complicated with luminal thrombosis.      The great majority of coronary plaques will remain quiescent, at least from a clinical point     of view.      Acute coronary syndrome is primarily precipitated by a ruptured plaque. The precipitating     factor or condition may be found outside rather than inside the plaque.      The challenge is to find the plaque(s) destined for the next thrombus-mediated heart     attack(s), treat, and thus avoid the heart attack(s). Identification of vulnerable plaques     has become a key issue. The natural history of individual plaques (risk of thrombosis) is     unknown and needs to be established.      Multidetector computed tomography (MDCT) can provide angiography and imaging of the vessel     wall (detection, quantification and characterization of plaques).      The intention of this project is to evaluate the accuracy of coronary MDCT in identifying and     differentiating the morphology of coronary atherosclerotic plaques.   "
201815|NCT00482664|"     CP-866,087 is a non-hormonal compound, acting on the central nervous system, which has been     shown in animal models to restore sexual function.   "
201842|NCT00483015|"     We wish to discover if there is a difference in the presentation, response to treatment and     survival of never- smokers with lung cancer as compared to ever- smokers.      We also plan to obtain tumor specimens to compare the genetic and proteomic expression     between smokers and never smokers   "
201816|NCT00482677|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving radiation therapy     together with temozolomide may kill more tumor cells. It is not yet known whether radiation     therapy and temozolomide are more effective than radiation therapy alone in treating     glioblastoma multiforme.      PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to     see how well they work compared with radiation therapy alone in treating patients with newly     diagnosed glioblastoma multiforme.   "
201817|NCT00482690|"     Analysis of aldeyde biomarkers of exposure and host response The purpose of this prospective,     open-label, clinical trial is to establish the feasibility and validity of exhaled breath     condensate (EBC) biomarkers for use in studies designed to evaluate harm reduction strategies     of smoking. This will be accomplished by measuring selected markers in EBC believed related     to the pathogenesis of lung disease before and after a smoking cessation intervention.   "
201818|NCT00482703|"     The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered     for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid     leukemia (CML) once daily (QD) or twice daily. (BID)   "
201819|NCT00482716|"     RATIONALE: Epoetin alfa and epoetin beta may cause the body to make more red blood cells. Red     blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known     whether epoetin alfa or epoetin beta are more effective when given with or without iron     infusion in treating anemia in patients with cancer.      PURPOSE: This randomized phase III trial is studying epoetin alfa or epoetin beta to compare     how well they work with or without iron infusion in treating anemia in patients with cancer.   "
201820|NCT00482729|"     The purpose of this study is to investigate the efficacy and safety of an investigational     treatment for type 2 diabetes mellitus.   "
201821|NCT00482742|"     The main objectives of the study are:      To evaluate the performance and safety of the CiTop guidewire, while attempting to cross thru     total occlusions of various dimensions and morphology.      To compare the safety and efficacy of the CiTop guidewire with standard guidewires in terms     of impact on the treated artery. Following operation of the CiTop device, angiography     demonstrated successful crossing of the occlusion with no visible evidence of arterial wall     injury, dissection, or distal embolization.      To assess ease of operation and the level of integration of the CiTop with standard     interventional angiography procedure: Balloon angioplasty, placement of stent.   "
201822|NCT00482755|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed.      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with     newly diagnosed stage II or stage IIIA breast cancer that can be removed by surgery.   "
201823|NCT00482768|"     The purpose of this study is to test an intervention in primary care clinics to improve three     risk factors for diabetes complications: glucose control, blood pressure and cholesterol.     Subjects in the study will be clinic staff and clinicians, not patients. The intervention is     Practice Facilitation. Practice facilitation occurs when a trained facilitator meets with a     team of staff and clinicians in each practice over a period of several months. Facilitation     meetings create time for learning and reflection by members of the team and improves their     communication so that they can adopt and implement a strategy to improve patient care   "
201824|NCT00482781|"     The purpose of this study is to examine the relationship between receipt of DTaP and the     occurrence of prolonged episodes of apnea and bradycardia in preterm infants, while employing     a random control study design and an objective assessment of cardiorespiratory events.   "
201825|NCT00482794|"     Antiphospholipid antibody syndrome (APS) is characterized by the presence of antiphospholipid     antibodies, which are proteins in the blood that interfere with the body's ability to perform     normal blood clotting. Clinical problems associated with antiphospholipid antibodies include     an increased risk for the formation of blood clots in the lungs or deep veins of the legs,     stroke, heart attack, and recurrent miscarriages. It is possible that some people with APS     have a genetic predisposition for developing the syndrome. This study will use a genetic     strategy to identify potential inherited risk factors for the development of APS by     recruiting people with APS who have family members also affected by the syndrome or by     another autoimmune disorder, such as lupus or rheumatoid arthritis.   "
201826|NCT00482807|"     RATIONALE: Specialized radiation therapy that delivers a high- dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Androgens can cause the growth     of prostate cancer cells. Antihormone therapy, such as goserelin and bicalutamide, may lessen     the amount of androgens made by the body. Giving radiation therapy together with chemotherapy     and hormone therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when     given together with intensity-modulated radiation therapy and hormone therapy in treating     patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.   "
201843|NCT00483028|"     To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing     (NPT) and brain Proton Magnetic Resonance Spectroscopy.   "
201844|NCT00483041|"     To evaluate the effect of MEDI-528 in adults with atopic asthma.   "
201861|NCT00483262|"     The purpose of this research study is to determine the safety of CCI-779 (Temsirolimus) and     bortezomib (Velcade), and the highest dose of this drug that can be given to people safely.     We will also be looking at how the combination of the two drugs may work against multiple     myeloma. CCI-779 (Temsirolimus) is a drug that appears to stop myeloma cells from growing.   "
201862|NCT00483275|"     Objective of the study is to evaluate the effect of a multimodal therapy on the basis of     current guidelines on fall prevention consisting of a 12-months intervention with     Alfacalcidol and calcium, patient education and a mobility program in a group of patients 65     years of age or older with an impaired renal function in comparison to a group receiving     usual care.   "
201845|NCT00483054|"     The randomized controlled trial is conducted among antiretroviral naive co-infected HIV and     tuberculosis patients who receiving rifampicin-based antituberculous regimen fro at least 4     weeks butt not exceed 16 weeks before enrolment. All patients receive the same backbone     regimen of stavudine (30 mg/40 mg twice daily)+ lamivudie 150 mg twice daily. They are     randomized to receive nevirapine 400 mg/day twice daily vs efavirenz 600 mg/day at bed time.     All patients are followed through 144 weeks after initiation of antiviral therapy. The     primary objective are to compare the proportion of patient who achieve undetectable plasma     HIV-1RNA<50 copies/ml at week 48. The previous reports demonstrated that the standard doses     of both nevirapine and efavirenz coulde be used among co-infected HIV and tuberculosis     patients who receiving rifampicin even though plasma levels are somewhat reduced by     rifampicin. However, there have been not been a randomized control trial to compare these two     regimens. Thus, this trial will provide the efficacy data between these two regimens.   "
201846|NCT00483067|"     Primary Objectives:        1. To determine the response rate, progression-free survival (PFS) and overall survival of          patients who receive 2-CdA + Ara-C.        2. To examine if there is any clonality in the cytokine expression of helper T cells or          cytokine receptor expression of eosinophils.        3. To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.   "
201827|NCT00482820|"     Studies show that children with high levels of anxiety tend to pay more attention to     threatening stimulus in the environment. They tend to attend to these stimuli and have     difficulty to disengage from them. These attention biases enhance and maintain the level of     anxiety. The aim of this study is to test a method of therapeutically intervention which     focuses on shifting these attentional biases, with the use of a computer game which was     designed to train the child to focus his/her attention away from the threatening stimuli and     to focus on natural or positive stimuli. We will recruit 160 children with ongoing anxiety     disorders who seek treatment. We will first assess threat-related attention bias and anxiety     symptoms using structured psychiatric interviews and questionnaires. We will then randomly     assign these children to one of four conditions: training to avoid threatening stimuli and     attend to neutral stimuli; control placebo-training for threat-neutral stimuli; training to     attend to positive stimuli and avoid neutral stimuli; and, control placebo-training for     positive-neutral stimuli. Upon completion of training we will again assess attention bias and     anxiety.      Two sets of predictions will be tested, one set concerns the effects of training on     attention, and the other concerns the effects of training on anxiety. In terms of training     effects on attention, we hypothesize that children with anxiety disorders can be trained to     either avoid threat or attend to positive stimuli. In terms of training effects on anxiety     symptoms, we hypothesize that the experimental training sessions will produce greater     reduction in symptoms of anxiety than the placebo-control training sessions.   "
201828|NCT00482833|"     Open label, randomised, phase III multicenter trial.   "
201829|NCT00482846|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Keratinocyte growth factors, such as palifermin, may help prevent symptoms of mucositis, or     mouth sores, in patients receiving melphalan before a peripheral stem cell transplant for     multiple myeloma.      PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when     given together with palifermin in treating patients undergoing an autologous peripheral stem     cell transplant for stage II or stage III multiple myeloma.   "
201830|NCT00482859|"     The purpose of this week long study is to describe sleep and problems with sleep in women     diagnosed with Fibromyalgia syndrome.   "
201831|NCT00482872|"     RATIONALE: Studying gene mutations in samples of DNA from patients with head and neck cancer     and a family history of cancer may help doctors learn more about the development of cancer in     families.      PURPOSE: This clinical trial is studying germline mutations in patients with head and neck     cancer and a family history of cancer.   "
201832|NCT00482885|"     High Resolution Manometry (HRM) is a new advance in oesophageal measurement that permits the     acquisition of pressure data through the entire length of the oesophagus over time via     closely spaced sensors that continuously record the motor activity of the oesophagus. This     allows not only contractile pressure to be measured, but also the coordination     (proximal-distal) of contractions and the development of effective intra-bolus pressure (the     force that drives bolus movement).      The study hypothesis is that (1) there will be a progressive increase in peristaltic pressure     and decrease in velocity as the subjects move from the upright, through the supine to the     upside down position and (2) the increase in pressure will be most evident in the     mid-oesophagus at the transition zone between the striated and the smooth muscle     contractions.   "
201833|NCT00482898|"     A study to test the effect of MK0359 in lessening the symptoms of asthma as compared to     placebo.   "
201834|NCT00482911|"     RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the     tumor. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving lenalidomide together with sunitinib and low doses of cyclophosphamide once     a day may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving lenalidomide together with sunitinib     and cyclophosphamide works in treating patients with stage IV eye melanoma.   "
201835|NCT00482924|"     To work against the increasing burden of obesity, the STYJOBS / EDECTA (STYrian Juvenile     OBesity Study / Early DetECtion of Atherosclerosis) project was started at the Medical     University of Graz in 2003. STYJOBS / EDECTA is a prospective, observational study to improve     the understanding of atherosclerosis, cardiovascular risk, immune mediated low grade     inflammation, and metabolic changes in obesity by investigation of the non-biased early     phase.      The main focus is the early identification of obesity and worse lifestyle related     individual high risk profiles for cardiovascular/metabolic/immune-inflammatory disease in     juvenile, young, and adult persons up to the age of 65 years. Based on this information, new     and effective strategies are developed for preclinical diagnostics and early intervention.     Concerning mechanisms of obesity and bad lifestyle associated pathologic conditions, risk     biomarker patterns, chronic immune-mediated inflammation, disturbed adipokine balance,     individual adipose tissue topography, brown and white adipose tissue (BAT/WAT) function,     addiction like behaviour, genetics/epigenetics, early vascular pathology, and fatty liver     disease are in focus of research. Interventional branches of study tested a holistic strategy     comprehending sports, and lifestyle modification for efficiency. A better understanding of     the role of a disturbed energy expenditure in the etiology of obesity should give the basis     for new paradigms in therapy of obesity.      The investigative spectrum of STYJOBS / EDECTA was recently extended also to non-obese body     weight extremes i.e. underweight/anorectic people.   "
201836|NCT00482937|"     The primary objective of this study is to establish the safety of CD-NP in normal human     volunteers.   "
201837|NCT00482950|"     This study is to test the efficacy and safety of PHX1149T in combination with metformin, a     glitazone, or metformin and a glitazone in subjects with Type 2 diabetes for 12 weeks. After     completing the 12 week double blind part of the study, subjects can enter an open label     extension study   "
201838|NCT00482963|"     The purpose of this study is to determine if blood levels of the hormonal emergency     contraceptive agent, Plan B, are altered by concomitant use with the HIV medication,     efavirenz.   "
201839|NCT00482976|"     To determine if protein kinase C beta plays a significant role in vascular endothelial     dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes     mellitus.   "
201847|NCT00483080|"     The main objective of the trial is to document the progression free survival (PFS) in     advanced or metastatic colorectal cancer patients treated with NGR-hTNF as single agent.     Safety will be established by clinical and laboratory assessment according to NCI-CTC     criteria.   "
201848|NCT00483093|"     The main objective of the trial is to document the safety of the combination (escalation     doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80     mg/sqm). Safety will be established by clinical and laboratory assessment according to     National Cancer Institute Common Toxicity Criteria (NCI-CTC ).   "
201850|NCT00483119|"     The purpose of this study is to compare two standard treatments for pemphigus to determine     which more effectively improves the clinical manifestations of the disease and decreases     serum level of the autoantibodies which cause the disease.   "
201851|NCT00483132|"     Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy.      High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma     (LBL).   "
201852|NCT00483145|"     To evaluate efficacy and adverse effect from long-pulsed dye laser versus long-pulsed dye     laser-mediated photodynamic therapy for acne vulgaris and rosacea.   "
201853|NCT00483158|"     The purpose of this study is to study the safety of single doses and multiple doses of     Finafloxacin hydrochloride in healthy volunteers. The level of Finafloxacin hydrochloride     will be measured in the subjects blood and urine. One part of the study will assess if     Finafloxacin hydrochloride eradicates Helicobacter pylori, a stomach bacteria. Another part     of the study will assess the activity of the drug in urine.   "
201854|NCT00483171|"     The purpose of this study is to determine if CP-945,598 is effective in the prevention of     weight regain in obese subjects.   "
201855|NCT00483184|"     The purpose of this study is to determine the safety and efficacy of natural human interferon     alpha (IFN alpha) on size, number, incidence and pain of oral ulcers associated with Behçet's     Disease (BD).   "
201856|NCT00483197|"     The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD     in individuals who are awaiting heart transplants.   "
201857|NCT00483210|"     Resistance to the hypoglycemic action of insulin develops within 7 days of bedrest in young,     healthy volunteers. We propose that the same event occurs in elderly individuals confined to     bed, that alterations in lipid metabolism are, at least in part, responsible for the insulin     resistance associated with bedrest, and that the accumulation of intracellular triglyceride     (TG) in liver and muscle will play a role in impairing insulin action. Further, we propose     that the PPARα (Peroxisome Proliferator-Activated Receptor Alpha) agonist fenofibrate will     increase tissue fatty acid disposal by activating mitochondrial oxidative capacity, thereby     improving insulin sensitivity.      We will investigate a series of specific hypotheses designed to examine the role of altered     lipid metabolism in the development of insulin-resistance associated with bedrest. Further,     since inactivity is likely a principal factor in the development of insulin resistance in the     elderly, the response to the inactivity imposed by bedrest represents an acceleration of the     normal development of insulin resistance in elderly individuals. Therefore, the results of     this study will also be pertinent to the understanding of the mechanisms responsible for the     natural development of insulin resistance in free-living elderly.   "
201858|NCT00483223|"     The purpose of this research study is to :        -  Determine how effective cisplatin or carboplatin is in slowing the time it takes for ER          negative (estrogen-receptor-negative), PR negative (progesterone receptor-negative),          HER2 negative (human epidermal growth factor receptor 2) breast cancer to progress.          Cisplatin and carboplatin are anti-cancer chemotherapy drugs that stop cancer cells from          growing abnormally and is used to treat other cancers.        -  Evaluate a new biomarker to help determine which breast cancers are most likely to          respond to cisplatin chemotherapy      The hypothesis is that Triple Negative metastatic breast cancer may be particularly sensitive     to platinum, and that a subgroup of those patients may have a marker in their tumors that     predicts response.   "
201859|NCT00483236|"     -  Chronic severe mitral regurgitation can lead to symptoms and left ventricular          dysfunction.        -  The purpose of this study is to prospectively follow patients with non-ischaemic          cardiomyopathy who are eligible for mitral valve repair surgery and primarily measure          the quality of life through the Minnesota Living with Heart Failure Questionnaire & the          Kansas City Cardiomyopathy Questionnaire.   "
201863|NCT00483288|"     RATIONALE: Written educational materials and counseling by phone may help promote follow-up     care in women with abnormal Pap smears.      PURPOSE: This clinical trial is studying how well written educational information and phone     calls work in increasing follow-up care in Hispanic women with abnormal Pap smears.   "
201864|NCT00483301|"     The purpose of this study is to compare the effects, good and/or bad, of Carboplatin and     ABI-007 (Abraxane) in combination with Sorafenib (BAY 43-9006) on Melanoma.   "
201865|NCT00483314|"     The purpose of this study is determine if oral N-acetylcysteine is effective in lowering     homocysteine in individuals with homocystinuria.   "
201866|NCT00483327|"     The purpose of this trial is to study the efficacy, toxicity, and tolerability of a standard     hormonal regimen of Megestrol Acetate (Megace) in the treatment of Atypical Endometrial     Hyperplasia or well to moderately differentiated endometrial carcinoma.   "
201867|NCT00483353|"     The current study will investigate nasal inflammatory markers obtained by filter paper     collection techniques, in subjects with allergic rhinitis, determining the most appropriate     time points and handling conditions, prior to running a larger study with subjects with     allergic rhinitis.   "
201868|NCT00483366|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and     capecitabine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving imatinib mesylate together with gemcitabine     and capecitabine may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine and     capecitabine when given together with imatinib mesylate in treating patients with advanced     solid tumors.   "
201925|NCT00490711|"     The purpose of this study is to evaluate the efficacy of paclitaxel and carboplatin followed     by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.   "
201869|NCT00483379|"     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the     body's cells to break down glycogen (a stored form of sugar) within specialized structures     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates     and is stored in various tissues, especially heart and skeletal muscle, which prevents their     normal function. The objective of this exploratory study is to evaluate the safety and     efficacy of alternative dosing regimens of alglucosidase alfa in patients with Pompe disease     who have not demonstrated an optimal response to the standard dosing regimen of 20 mg/kg     every other week after a minimum of 6 months treatment immediately prior to study entry.   "
201870|NCT00483392|"     The purpose of this study is to evaluate and compare the effects of treatment with     rosiglitazone and metformin on insulin resistance in patients infected with Human     Immunodeficiency Virus on stable Highly Active Antiretroviral Therapy including a Protease     Inhibitor after the period of 48 weeks.   "
201871|NCT00483405|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy     together with a monoclonal antibody may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine     together with cetuximab works in treating patients with advanced liver cancer.   "
201872|NCT00483418|"     The purpose of this study is to survey the total serum testosterone levels in male patients     with hormone-independent malignancies. The prevalence of hypogonadism is not known, but is     thought to be significant. Results will be adjusted for age and stratified for type of     cancer, stage, study site,and presence of opiate use for pain management, which is known to     reduce testosterone levels.   "
201873|NCT00483431|"     Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular     health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins,     menaquinone-7 (MK-7) has been identified as the most effective cofactor for the carboxylation     reaction of Gla-proteins such as osteocalcin and matrix-gla protein. The question remains     which dosage of MK-7 leads to optimal carboxylation levels of these proteins.      The primary objective of this double-blind randomized intervention study is to establish the     optimal dose of MK-7 for carboxylation of the vitamin K-dependent proteins osteocalcin in     bone and matrix-gla protein in the vessel wall. The optimal dose will be the concentration at     which osteocalcin and matrix-gla protein are > 90% in the active (=carboxylated) form.   "
201874|NCT00483444|"     The purpose of this study is to see whether providing education and counseling after a mild     traumatic brain injury will help in preventing symptoms from becoming chronic over the first     six months after injury.   "
201875|NCT00483457|"     RATIONALE: Studying samples of tissue and blood in the laboratory from patients with cancer     receiving epidermal growth factor receptor (EGFR) inhibitors may help doctors understand the     effects of EGFR inhibitor therapy in the skin.      PURPOSE: This laboratory study is looking at the effects of EGFR inhibitors in the skin of     cancer patients.   "
201876|NCT00483470|"     As per request by the Heath Authorities, the present clinical study will assess the     immunogenicity and safety   "
201877|NCT00483483|"     The objective of this study is to test in a randomized controlled trial the effectiveness of     a US secondary HIV prevention program to reduce HIV risk behaviors, STD acquisition, and     alcohol consumption among HIV-infected Russians with risky drinking.   "
201878|NCT00483496|"     Commercially available external photoprotectors (EP) do not provide adequate protection     against ultraviolet A (UVA) and visible wavelengths. The proposed medicinal product V0096 CR     (formula RV3131A-MV1166) is a broad spectrum EP (bsEP). The rationale for the use of V0096 CR     (formula RV3131A-MV1166) in the proposed condition is based on its ability to broadly block     the UVA radiations and visible light that are known to trigger solar urticaria (SU).   "
201879|NCT00483509|"     The main objective of the trial is to document the progression free survival (PFS) in     advanced or metastatic SCLC patients affected by advanced or metastatic small cell lung     carcinoma (SCLC) previously treated with at least one therapeutic regimen   "
201880|NCT00483522|"     This study seeks to determine if telephone counseling improves the outcome for persons with     moderate to severe traumatic brain injury (TBI).   "
201881|NCT00483535|"     GW273225 is in development for epilepsy and bipolar disorder and can affect women of child     bearing potential. A clear understanding of the potential interaction between oral     contraceptives and GW273225 is therefore important for clinical investigation of GW273225 in     a large number of patients. This study will investigate whether there is any effect of     GW273225 upon the components of combined oral contraceptive, and also whether taking oral     contraceptives affects the pharmacokinetics (PK) of GW273225.      26 healthy female subjects, aged 18-45 years will take an oral contraceptive (150ug     levonorgestrel and 30ug ethinylestrdiol; The study will include a screening period, two     cycles on oral contraceptive with GW273225 at 25 mg once per day administered from the start     of the second COC cycle for 47 days. There will be a follow-up visit 14-21 days later.   "
201882|NCT00483548|"     The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood     stabilizer is safe and effective in the short term treatment of Bipolar I Depression.     Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on     a therapeutic dose of one of these mood stabilizers for at least 4 weeks.   "
201883|NCT00483561|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as etoposide, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving gefitinib together with etoposide     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gefitinib together with etoposide     works in treating patients with advanced prostate cancer that did not respond to hormone     therapy.   "
201943|NCT00490945|"     The purpose of this study is to assess the safety and efficacy of VEC-162 compared to     matching placebo on circadian phase shift and sleep parameters.   "
201884|NCT00483574|"     This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in     subjects at 9 months and at 12 months of age when the second dose is given concomitantly with     other pediatric vaccines routinely administered in the US.      Safety Objective:      To describe the safety profile of two doses of Menactra® Vaccine.   "
201885|NCT00483587|"     Rationale: A safety and dose defining study in which the investigators hypothesize that in     patients with acute coronary syndrome without ST-elevation (NSTEMI) treatment with heme     arginate results in better clinical outcome by inducing the heme oxygenase-1 (HO-1) pathway.      Objective: 1) Is induction of HO-1 and its degradation products, especially bilirubin, safe     in patients with an acute coronary syndrome without ST-elevation; 2) What is the optimal     effective dose to administer in patients with NSTEMI; 3) Are HO-1 and its degradation     products endogenously activated in patients with acute coronary syndrome; 4) Does treatment     with heme arginate result in a less cardiac damage; 5) Which other cardioprotecting pathways     are activated by administration of heme arginate?      Study population: Male and female patients with confirmed acute coronary syndrome without     ST-elevation, between 18 - 80 yr old.      Intervention: 10 patients receive a single administration of heme arginate (3 mg/kg),     administered intravenously in 15 minutes directly after admission; 10 patients receive two     administrations of heme arginate (3 mg/kg) on day 0 and 1; 10 patients receive three     administrations of heme arginate (3 mg/kg) on day 0, 1 and 2 after admission, administered     intravenously in 15 minutes. To determine endogenous levels of HO-1 and time course of HO-1     activation after NSTEMI, blood is drawn and the same assays are performed in 15 patients with     NSTEMI. As controls for the blood tests, blood is drawn and the same assays are performed in     15 patients with non-typical angina pectoris in whom no cardiac disease could be detected     from the investigators out-patient clinic.      Main study parameters/endpoints: The primary endpoint is the incidence rate of adverse events     between the three treated groups. This includes hemodynamic monitoring, rhythm monitoring and     biochemical and hematological difference between the three treated groups. Secondary     endpoints are the differences from baseline between heme arginate treated groups in activity     of the HO-1 pathway, including, but not limited to, HO-1 activity, free heme, bilirubin     (direct and indirect) levels, serum ferritin, and carbon monoxide (CO). Furthermore,     differences between heme arginate treated groups on NTproBNP, CK-MB and Troponin T and     difference between heme arginate treated subjects in LVEF measured by echocardiography, 3 and     7 days and 6 months after NSTEMI.   "
201886|NCT00483600|"     To determine the appropriate dose and safety of a preventative dose of fondaparinux, an     anticoagulant medication (blood thinner) in patients with kidney disease.   "
201887|NCT00483613|"     -  Daily stress can worsens the clinical course of lupus.        -  Objective: to determine the efficacy of the stress management therapy in a group of          patients with lupus.        -  45 patients with lupus and high daily stress participated in this clinical trial.        -  Two groups resulted: a control group (CG) that received the usual care and a therapy          group (TG) that received a cognitive behavioral therapy.        -  The therapy consisted of ten consecutive weekly sessions.        -  The measured variables were psychological, clinical, immunological and quality of life.          At the basal moment and after 3, 9 and 15 months.        -  Statistical analysis showed a significant reduction in the levels of depression, anxiety          and daily stress in the therapy group, compared to the usual care group, a significant          improvement in quality of life, improvements in the reported symptoms (cardiovascular,          respiratory, cutaneous and musculoskeletal.   "
201888|NCT00489593|"     The goal of this clinical research study is to find the highest tolerable dose of the drug     Olanzapine that can be given to patients with advanced cancer who are experiencing weight     loss. Researchers want to find out if Olanzapine can help decrease weight loss in patients     who are experiencing it because of cancer. How this drug affects performance status,     cancer-related symptoms, and nutritional status in patients with advanced cancer will also be     studied.   "
201889|NCT00489606|"     To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and     tamsulosin, phase I study in healthy volunteers was designed.   "
201890|NCT00489619|"     Malaria and sexually transmitted infections (STIs) are common in pregnant women in Africa and     are important preventable causes of poor birth outcomes and maternal and infant mortality.     This study investigated baseline characteristics of the population including: rates of STIs     including HIV, prevalence of malaria and tuberculosis (TB) and resistance to common     antimalarial drugs.   "
201891|NCT00489632|"     Overall Objective:      The overall objective of this cross-sectional psychosocial study is to examine     illness-related factors, family context factors, and child resiliency as predictors or     correlates of child adjustment to leukemia treatment.      Primary Objective 1:      1(a): To examine illness-related factors (i.e., child's health and physical functioning and     severity of the child's illness) as predictors of child psychological adjustment to leukemia.      1(b): To examine relapse status as a grouping variable affecting child psychological     adjustment to leukemia.      1(c): To examine stage of treatment as a grouping variable affecting child psychological     adjustment to leukemia.      Primary Objective 2:      -To examine family context factors (i.e., family psychosocial risk and parental emotional     distress) as correlates of child psychosocial adjustment to leukemia treatment.      Primary Objective 3:      -To examine child resiliency as a predictor of child psychological adjustment to leukemia     treatment.      Secondary Objectives:        -  One secondary objective of the study is to examine parental distress as a moderator          affecting parental report of child adjustment to leukemia as compared to the child's          self-report of adjustment.        -  Another secondary objective of the study is to develop a model by which the relative          contribution of each predictor variable (as determined by analyses of primary          objectives) as well as their interrelatedness can be understood in relation to child          psychosocial adjustment.        -  A third secondary objective of the study is to examine demographic variables as          covariates in the main analyses. These variables include: age, grade, site, gender,          ethnicity, type of leukemia, staging, time spent in treatment, age at diagnosis, and          whether the child is undergoing standard or experimental treatment.   "
201892|NCT00489645|"     • To examine the influence of acute glycaemia (normoglycaemia and hyperglycaemia) on gastric     emptying kinetics in patients with type 1 diabetes and non diabetic subjects when treated     with subcutaneous (SC) injections of pramlintide.   "
201906|NCT00489827|"     The main purpose of this study is to determine whether intravenous glutamate infusion given     in association with surgery for unstable coronary artery disease can protect the heart from     myocardial injury, postoperative heart failure and death.   "
201893|NCT00489658|"     This case series study follows on a terminated randomised clinical trial in a nearby location     of Uganda, in which the combination of eflornithine + nifurtimox showed very promising     efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this     combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness)     patients.   "
201894|NCT00489671|"     RATIONALE: Measuring cadmium levels in urine samples from patients with chronic pancreatitis     may help doctors predict which patients may develop pancreatic cancer. It may also help the     study of cancer in the future.      PURPOSE: This clinical trial is studying urine cadmium levels in predicting pancreatic cancer     risk in patients with chronic pancreatitis.   "
201895|NCT00489684|"     The study is a multi-modal multi-tissue human experimental pain study in 24 healthy     volunteers. The study is a randomized cross-over study. The effect of 2 opioids will be     compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin     and oesophagus, to sensitize these tissues. The pain thresholds before and after opioid     administration will be compared. The hypothesis is that the difference in effect of the     opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common     phenomenon the clinic, the findings in this study may lead to a better understanding of the     treatment of pain. The study will include an explorative study of the effect of Morphine of     pain processing in the brain, this will provide us with new insight in the effect of the     opioids of pain processing in the brain.   "
201896|NCT00489697|"     Bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a     new standard for the treatment of metastatic colorectal cancer. Contrast-enhanced ultrasound     with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly     hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies.     The aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness     of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy     in patient with metastatic colorectal cancer. The primary objective of this study is to     compare the functional vascular changes related to bevacizumab based chemotherapy and     evaluated by hepatic contrast-enhanced ultrasound with classic RECIST criteria. The secondary     objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the     pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases     evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships     between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the     bevacizumab.   "
201897|NCT00489710|"     RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well talabostat works in treating patients with     metastatic kidney cancer.   "
201898|NCT00489723|"     The purpose of this study is to determine if there is a role of prophylactic therapy with     tamsulosin prior extracorporeal shock wave lithotripsy to avoid development of steinstrasse.     150 persons that will go to Extracorporeal shock wave lithotripsy will randomize to 2 groups.      Group 1 -of 75 persons will recieve tamsulosin 0.4 mg x 1/d 2 days before the lithotripsy .      Group 2 - of 75 persons will not recieve tamsulosin. 48 hour after the ESWL all 2 group will     take abdominal radiograph to evaluate the presence of steinstrasse.   "
201899|NCT00489736|"     The objective of this study is to compare the efficacy and safety of dronedarone to that of     amiodarone for the treatment of patients with atrial fibrillation.   "
201900|NCT00489749|"     The purpose of this study was to determine the effect of protected early weightbearing (PEWB)     compared to non-weightbearing (NWB) after surgery for an Achilles tendon rupture (ATR) on     health related quality of life (HRQL) in the initial six week period after surgery,     functional recovery over time, return to work and activity and complications. We hypothesized     that PEWB following ATR repair would result in: i) improved HRQL in the initial postoperative     period, ii), a quicker recovery of HRQL, strength and endurance, iii) earlier return to work     and sport, and iv) no increase in complications, such as re-rupture compared to NWB.   "
201901|NCT00489762|"     The Housing, Heating and Health Study has enrolled 409 households with ineffective heaters,     who have a child with asthma between 6 and 12 years.      In the winter of 2005, houses were insulated and baseline measures taken of indoor     temperatures, nitrogen dioxide, with more intensive indoor air quality monitoring in a     sub-sample of 33 homes.      Objective data are being collected on the household’s health and energy usage. The households     randomly assigned to the intervention group will have new heaters installed over the summer.      Results will be available after the follow-up data collection in 2006.   "
201902|NCT00489775|"     To determine if duloxetine works just as well as paroxetine in the treatment of major     depressive disorder.   "
201903|NCT00489788|"     Magnetic Resonance Imaging (MRI) is a non-invasive test that can look at the heart without     using radiation. An MRI will allow the doctors to look at the heart in order to assess how     well the ventricle is pumping, the amount of blood that it is pumping in addition to how much     it is stretching. An engineer at Georgia Tech has developed a new way of looking at an MRI.     It is believed that this new way of looking at an MRI may be better able to tell us when to     replace the valve in these children. If this new process works, not only can we apply it now     but we will be able to look at previously performed MRIs and gather more information about     these children and their heart function in order to help these and other children in the     future.      We are planning on enrolling 30 subjects in this study. Some of the subjects will be enrolled     and have their MRI strictly for the purpose of this study. Some of the subjects will be     already scheduled for a routine MRI of their heart and we will ask them if we can do extra     images for the study while they are already here.   "
201904|NCT00489801|"     Hypothesis: Home-based cardiac rehabilitation is as effective as comprehensive centre-based     cardiac rehabilitation in patients older than 65 years.   "
201905|NCT00489814|"     The goal of this research study is to collect information on the side effects of proton     radiation therapy given for the treatment of prostate cancer as well as the effect of proton     therapy on quality of life. Information on your treatment and how you react to the treatment     will be collected. Researchers will use this information to try to understand how people     tolerate proton radiation therapy for prostate cancer.   "
201907|NCT00489840|"     Investigation to evaluate Anecortave Acetate in the treatment of chronic central serous     chorioretinopathy   "
201911|NCT00489892|"     This study is designed to examine the effects of a wake-promoting agent (Modafinil) on     working memory (WM) in persons with moderate to severe TBI utilizing a double blinded placebo     controlled methodology. Our approach is to evaluate participants with BOLD fMRI and a limited     neuropsychological battery to examine WM performance before and after pharmacological     intervention.      Hypotheses        1. Because increased cognitive effort (as a function of decreased efficiency after TBI) is          presumed to underlie fMRI activation dispersion that is seen during central executive WM          tasks, we anticipate an attenuation of cerebral activation in prefrontal cortex during          pharmacological intervention with Modafinil when compared to placebo administration on          the mPASAT and vigilance testing.        2. There will be a correlation between the decreased dispersion of the fMRI signal on scans          and improvement in neuropsychological measures when individuals are on Modafinil that is          not seen when they are taking placebo.   "
201912|NCT00489905|"     The purpose of this study is to assess the effect of zoledronic acid on bone mineral density     in prostatic cancer patients currently receiving androgen deprivation therapy.   "
201913|NCT00489918|"     A Multi-center study to determine effects of various doses of Macroflux PTH in women with     osteoporosis   "
201957|NCT00491127|"     The purpose of this study it to evaluate efficacy of gemcitabine with cisplatin and     dexamethasone in patients with aggressive non-Hodgkin's lymphoma who have previously     progressed on first line of chemotherapy with anthracyclines.   "
201914|NCT00490568|"     This is a Phase III, multicenter, open-label extension, single-group study in male and female     outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either     AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg     once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to     their existing dose of acetylcholinesterase inhibitor. Subject participation will last until     one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend     a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this     study is to evaluate the long-term safety and tolerability of RSG XR in subjects with     mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective     of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive     function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele     status.   "
201915|NCT00490581|"     The study hypothesizes that early housing after hospitalization with case management     integrated into the health and housing systems, will results in decreased use of costly     health services (i.e., hospitalizations and Emergency Room visits) with no negative affect on     health. To address this hypothesis the investigators implemented a Randomized controlled     trial of 407 homeless adults with chronic medical illness in Chicago. Eligible homeless     adults were enrolled during a hospitalization to intervention - Early housing with case     management - or usual care - usual case management and housing options. The investigators     followed the sample for 18 months with assessments at baseline, 1,3,6,9,12 and 18 months are     enrollment. Study measures include Quality of Life, Health service use, Alcohol and Substance     Use, housing and social and demographic characteristics.   "
201916|NCT00490594|"     The SeriACL device was developed as an alternative to an autograft (i.e., tissue that is     taken from a patient's own body) or an allograft (i.e., tissue that is taken from a cadaver)     for ACL reconstruction. The SeriACL device is made of silk yarns, knit and processed with     SeriCoat™ surface treatment which makes it easier to wet the material. The SeriACL device is     designed to be a temporary support structure to replace the torn ACL and to stabilize the     knee joint following surgical repair. It is designed to use the body's own healing process to     regenerate the patient's own new ligament tissue. As the new tissue grows and the support     structure is needed less over time, the SeriACL device is bioresorbed (i.e., broken down) by     the patient's body. The SeriACL device is designed to be installed with standard surgical     techniques for ACL repair.      This study is designed to test the safety of the SeriACL device in primary total ACL repair     in patients with a torn ACL. The study will evaluate whether repair of the ACL with the     SeriACL device will return the knee to normal function and what, if any, side effects will     occur.   "
201917|NCT00490607|"     The purpose of this study is to investigate the pathogenesis of hemangiomas of infancy as     they relate to normal pregnancies and those pregnancies complicated by placenta     abnormalities. Women of all gestational ages will be enrolled in the study. Maternal serum,     placental, and cord blood samples will be obtained for each subject. A medical history will     be obtained for each subject. Post-delivery a member of the study team will perform a     cutaneous exam of the infant to establish what birthmarks are present at birth. Mother will     receive four phone call follow ups to determine if the infant has had any skin changes. If     yes, mother will be asked to bring the child in for evaluation. If a hemangioma is diagnosed,     a blood draw will be performed.   "
201918|NCT00490620|"     This is a proof of principal study to determine whether combination anti-viral therapy with     Combivir impacts on hepatic biochemistry in patients with primary biliary cirrhosis   "
201919|NCT00490633|"     Pharmaceutical interventions, particularly vaccination, have been the principal public health     method of preventing and controlling seasonal influenza. Other less invasive     non-pharmaceutical interventions include the use of face masks and hand hygiene. In Asia,     masks are used extensively, especially in Japan, but with only circumstantial evidence of     efficacy. Although there are numerous studies that support hand hygiene as an effective     measure for decreasing transmission of enteric infections, there are fewer data assessing the     effect of hand hygiene on respiratory illnesses. Therefore it is proposed that a study be     conducted on the use of face masks with and without the use of hand hygiene in comparison to     no intervention in residence housing units of the University of Michigan. The interventions     will be carried out during a period of influenza transmission that is defined by surveillance     conducted at the University Health Service. Data will be collected on use of the     interventions and the occurrence of influenza and other illnesses. When illness occurs     meeting a case definition, specimens for viral isolation will be collected in all     intervention settings. Face masks could theoretically lead to a large reduction in     transmission frequency of influenza, especially if most transmission occurs by the airborne     (large or small droplet) route. Even a modest reduction could have a major effect during an     influenza pandemic.   "
201920|NCT00490646|"     The purpose of this randomized, Phase 2 open-label study was to assess the response rate of     participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or     metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to     treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.   "
201922|NCT00490672|"     Randomized controlled trial of CORFIS Programme.      The study objectives are as follows:        1. To determine the efficacy of a community based multiple risk factors interventional          strategy (CORFIS) for a treatment period of 6 months in patients on treatment for HT, DM          or HL.        2. The intervention shall consist of a purpose design and systematically organized disease          management program that employ multi-faceted interventions incorporating various          specific measures to maximize both clinician (as investigator) adherence with treatment          guideline and patient adherence with treatment.   "
201923|NCT00490685|"     The aim of the study is to evaluate, after radiological progression, efficacy in patients     treated with Sorafenib at a dose of 600 mg bid compared to that in patients treated with best     supportive care.      Primary efficacy objective is progression free survival from randomization.   "
201924|NCT00490698|"     Objectives:      Primary:      Evaluate clinical outcome based on the time to skeletal events after bone-targeted therapy      Secondary:        1. Evaluate clinical outcome based on the presence of calcification at the site of          osteolytic metastases        2. Measure bone-formation and resorption markers at baseline and during bone-targeted          therapy.        3. Assess effect of the bone-targeted regimen on serum cholesterol levels   "
201926|NCT00490724|"     The purpose of this exploratory study is to assess the efficacy and safety of nesiritide in     participants with acute (a quick and severe form of illness in its early stage) heart failure     (when the heart inadequately pumps blood through the body) including acute exacerbation of     chronic (lasting a long time) heart failure, administered intravenous (into a vein) bolus (a     large amount) followed by intravenous infusion (a fluid or a medicine delivered into a vein     by way of a needle).   "
201927|NCT00490737|"     This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.   "
201928|NCT00490750|"     The primary aim of this study is to test the hypothesis that Heller myotomy and Toupet     fundoplication result in a lower rate of reflux symptoms and positive 24-hour pH testing when     compared to Heller myotomy and Dor fundoplication.   "
201929|NCT00490763|"     The goal of this clinical research study is to find out if men who have a type of prostate     cancer that has been classified as low risk can safely not be treated for the disease.     Doctors want to know if patients with low risk cancer can avoid or postpone therapy and the     related side effects and still live as long as patients who immediately receive therapy.   "
201930|NCT00490776|"     This study will evaluate the safety and efficacy of LBH589B in adult patients with     refractory/resistant Cutaneous T-Cell Lymphoma and prior HDAC inhibitor therapy.   "
201931|NCT00490789|"     The purpose of this study is to determine the safety and efficacy of the mTOR inhibitor     sirolimus as a treatment for renal angiomyolipomas in patients with tyberous sclerosis     complex or sporadic lymphangioleiomyomatosis.   "
201932|NCT00490802|"     The purpose of this study is to learn whether or not the drug called oxytocin is helpful in     improving mood and social functioning in adults with autism.   "
201933|NCT00490815|"     This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert     of fluocinolone acetonide for the treatment of diabetic macular edema   "
201934|NCT00490828|"     Hydrocortisone has been shown to improve the early outcome of high risk patients after     cardiac surgery. A potential mechanism resulting in this effect may be its immunomodulatory     action. In this prospective interventional study this hypothesis is to be proven.   "
201935|NCT00490841|"     The purpose of this study is to determine whether the Herculink Elite Renal Stent System is     safe and effective in the treatment of renal artery stenosis in patients with less than     optimal angioplasty results and uncontrolled hypertension.      CAUTION: The Herculink Elite Renal Stent System Is An Investigational Device. Limited by     Federal (U.S.) Law to Investigational Use Only.   "
201936|NCT00490854|"     The purpose of the study is to compare the human insulin inhalation powder plus oral     anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus     oral anti-hyperglycemic medication on lowering the blood sugar level.   "
201937|NCT00490867|"     In the present study, endothelium dependent vasodilation will be induced by administration of     acetylcholine (ACh). To ascertain whether the vascular effects, if any, of α-lipoic acid are     limited to the endothelium, endothelium independent vasodilation will also be assessed by     administration of glyceroltrinitrate (GTN).      Study objectives To investigate the effect of α-lipoic acid therapy on endothelium dependent     and independent vasodilation, assessed by forearm blood flow (FBF), in patients with type 2     diabetes mellitus      Study design      Randomized, double-blinded, parallel group study for 23 days:      Day 1: FBF responses to acetylcholine and glyceroltrinitrate Day 2-22: intravenous infusion     of 600 mg α-lipoic acid or placebo Day 23: FBF responses to acetylcholine and     glyceroltrinitrate      Study population 30 subjects with type 2 diabetes      Study medication Acetylcholine (ACh) - intraarterial infusion, 25, 50, 100 nmol/min, infusion     period 3 minutes/dose level Glyceroltrinitrate (GTN) - intraarterial infusion, 4, 8, 16     nmol/min, infusion period 3 minutes/dose level α-lipoic acid – intravenous infusion of 600 mg     in 250 ml saline solution over 30 minutes      Main outcome variables Forearm blood flow (Ratio between intervention and control arm)     Additional outcome variables Arterial blood pressure, pulse rate, markers of inflammation and     oxidative stress, Insulin plasma levels, Glucose plasma levels      Risk/benefit assessment The insertion of intravenous cannula may cause mild and transient     pain. A minor hematoma may occur at the site of cannula insertion. The insertion of the     intraarterial cannula is performed under local anaesthesia and causes mild pain. The     meassurement of forearm bloodflow, espacialy the wrist cuff (>200 mmHG) may be uncomfortably.     Local administration of drugs through a needle in the brachial artery allows the study of     direct vascular effects of the drugs. Drug doses are 100 to 1000 times lower than a systemic     effective dose, therefore no systemic adverse events are expected. There is experience in     brachial artery infusions at our institution, and it is considered a safe technique. α-lipoic     acid was well tolerated in healthy volunteers and subjects with diabetes at doses up to 600     mg intravenously and 1800 mg orally with side effects comparable with placebo. Altogether 50     ml blood will be collected throughout the study.   "
201938|NCT00490880|"     The purpose of this study is to evaluate efficacy of gemcitabine and cisplatin combined with     either radical cystectomy or radiotherapy in the treatment of bladder cancer.   "
201939|NCT00490893|"     Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in     patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and     physicochemical properties which differ from human insulin. The aim of the present study is     to test whether this leads to altered hormone and symptom response during hypoglycemia.   "
201940|NCT00490906|"     The purpose of this study is to determine if certain drugs commonly used to treat multiple     sclerosis have an effect on bone health.   "
201941|NCT00490919|"     The objective of this study is to determine the analgesic efficacy and safety of     Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve     subjects with moderate to severe chronic low back pain. The double-blind treatment     intervention duration is 12 weeks, during which time supplemental analgesic medication     (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or     ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in     addition to study drug.   "
201942|NCT00490932|"     For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based     Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of     the cause or age group affected. This product has proven effective and contributed     substantially to the dramatic global reduction in mortality from diarrhoeal disease during     the period.      Based on more than two decades of research and recommendations by an expert group, WHO and     UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose     and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF     recommended that countries use and manufacture this new formulation in place of the old one.     While recommending this new ORS the experts also recommended that further monitoring is     desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of     sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the     new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including     cholera. If the new ORS is found safe, it will provide added confidence in its global use.   "
201944|NCT00490958|"     Background: In haemodialysis patients, chronic heart failure (CHF) is responsible for a high     mortality rate but, presently, very little data is available regarding this population.      Aim of the study: Aim of this study was to determine whether telmisartan decreases all-cause     and cardiovascular mortality and morbidity in haemodialysis patients with CHF and impaired     left ventricular ejection fraction (LVEF) when added to standard therapies with ACE     inhibitors.      Methods: A 3-year randomized, double-blind, placebo-controlled, multicentre trial was     performed involving 30 Italian clinics. Haemodialysis patients with CHF (NYHA class II and     III; LVEF 40%) were randomized to telmisartan or placebo in addition to ACE inhibitor     therapy. 332 patients were enrolled (165 telmisartan, 167 placebo), and drug dosage was     titrated to a target dose of telmisartan of 80 mg or placebo. Mean follow-up period was 35±5     months. Primary outcomes were all-cause mortality, cardiovascular mortality and CHF     hospitalization.   "
201945|NCT00490971|"     The purpose of this study is to evaluate the effectiveness and safety of oral     extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence     of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an     acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active     control arm, although the study is not designed to allow for a direct comparison of     olanzapine with paliperidone.   "
201946|NCT00490984|"     The objective of this study is to assess the feasibility, safety and effectiveness of tongue     stabilization using Aspire Medical Advance™ System for the treatment of obstructive sleep     apnea (OSA). Success is defined as a statistically significant reduction in AHI measured by     polysomnography (PSG) from baseline to 6 months.   "
201947|NCT00490997|"     The objective of this study is to compare Ketamine-Propofol with Ketamine-only in a     double-blind, randomised, controlled trial in a paediatric emergency department. We believe     that the combination of these two agents will provide a new and more effective option for     procedural sedation in paediatric emergency department patients. The hypothesis of the study     is that paediatric emergency department patients requiring procedural sedation for an     isolated orthopaedic injury with Ketamine-Propofol will have reduced total sedation time,     time to recovery, complications and improved satisfaction scores compared to patients     receiving Ketamine alone.   "
201948|NCT00491010|"     Patients undergoing atrial flutter ablation will be randomized to either the standard     ablation approach or voltage targeted approach. Patients will be followed for one year to     assess outcome of the ablation technique   "
201949|NCT00491023|"     Our aim in this study is to find out if we can locate the similar reduction in the     recruitment of macrophages, remodeling of vasculature and do they correlate in the number and     area of the islets in pancreas as in the mouse model.   "
201950|NCT00491036|"     Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to     a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related     artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion     criteria computerized randomization is performed to either PCI plus intraaortic balloon pump     (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care     treatment is performed according to standard care including hemodynamic monitoring using a     pulmonary artery catheter for optimal volume status adaptation and inotropic drug     administration.      The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be     30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and     clinical parameters will serve as surrogate for prognosis of the patients.   "
201951|NCT00491049|"     The purpose of this study is to determine whether additional topical application of 0.5%     levofloxacin is more effective in reducing the load of the conjunctival bacterial flora in     patients scheduled for intraocular surgery than preoperative irrigation of the conjunctiva     with povidone iodine alone.   "
201952|NCT00491062|"     The core of the neuronal lesions in Parkinson's disease (PD) is the progressive     degeneration of dopamine neurons in the substantia nigra. A significant loss of dopamine     neurons and the presence of Lewy bodies (a pathological hallmark in PD) in enteric neurons     have also been reported in that disease. These lesions may explain the frequent     gastro-intestinal dysfunction observed in PD patients. Alterations of other neuronal     populations within the enteric nervous system (ENS) as well as the mechanisms responsible for     these lesions (type of cell death, alteration of neuromediators gene expression) remain to be     identified. The aim of the study is to demonstrate that alterations of the human ENS in PD     can be evidenced by bowel biopsies and to determine whether they are correlated to the     severity of motor disability and to gastrointestinal dysfunction.   "
201953|NCT00491075|"     Primary Objective:        -  To determine the clinical activity of Pemetrexed + Gemcitabine in non-clear cell renal          cell cancer (RCC). Clinical activity will take into account response rate and          progression free survival (PFS).      Secondary Objectives:        -  To determine the toxicity of Pemetrexed + Gemcitabine in non-clear cell RCC.        -  To estimate the survival rate of patients with non-clear cell RCC treated with this          combination.   "
201954|NCT00491088|"     Specific Aim:        1. To prove our hypothesis that in severe OSA patients without daytime sleepiness, CPAP          worked as effectively as in severe OSA patients with daytime sleepiness.           Using sham CPAP as the optimal placebo, we conduct a randomized double-blind placebo          controlled trial to assess the CPAP effect in severe OSA patients without daytime          sleepiness.        2. To establish a model to predict the CPAP effect We use the parameters of five aspects,          including changes of polysomnographic parameters, improvement of sleepiness, fatigue and          QOL, sympathetic activity, inflammatory mediators and metabolism, to establish a model          to predict CPAP effect.   "
201955|NCT00491101|"     The aim of the study is valuation of quality of life (QL) in children with asthma and     analysis of the factors that can have influence on it. The clinical problems included into     the aim are to evaluate:        -  the correlation between the QL and asthma control        -  the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding          of each question and it's answers The results of this study can be very helpful in the          future in developing a questionnaires to use in Polish Primary Care, according to which          the investigators would be able to see whether the asthma in our patients is being well          controlled.   "
201956|NCT00491114|"     This is a phase II study where chemotherapy (gemcitabine) is given into the urinary bladder.   "
201959|NCT00491153|"     The purpose of this study is to estimate the sensitivity, specificity and positive and     negative predictive values of a positive Aridol challenge with respect to a specialist     pulmonologist diagnosis of asthma in corticosteroid naive subjects with asthma-like symptoms     and no previous diagnosis of asthma. The comparator is methacholine provocation   "
201960|NCT00491166|"     This is an investigator-sponsored trial (IST), an open-label pilot study, assessing the     safety and biologic activity of bromfenac in subjects with diffuse DME refractory to laser.   "
201961|NCT00491179|"     Chronic hepatitis C virus (HCV) infection is common in dialysis patients. Interferon     (IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in     immunocompetent patients. Two meta-analyses evaluating the efficacy and safety of     conventional IFN alfa monotherapy showed that the sustained virologic response (SVR) rates     were 37% and 33%, respectively; and the corresponding dropout rates were 17% and 29.6%,     respectively. The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis     patients showed conflicting results, with a more favorable outcome of patients treated with     pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated) than those treated with     pegylated IFN alfa-2b (0.5-1.0 μg/week: SVR 12.5%, poorly tolerated), Currently, IFN-based     therapy to treatment HCV infection should be initiated in dialysis stages, because the use of     IFN in RT patients harbors high risks of acute graft rejection,and have low response rates     under the concomitant use of immunosuppressive agents.      Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the     general patients and achieve a higher SVR rate than IFN monotherapy, is considered     contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe     hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus     low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of     treatment.In addition, a recent study including 6 patients with combination of pegylated IFN     alfa plus low dose ribavirin also showed a SVR rate of 50%.      Although dialysis patients have a higher SVR rate to conventional IFN or pegylated IFN     monotherapy than patients with normal renal function for HCV therapy. More than half of these     patients are relapsers or non-responders to IFN monotherapy. Retreatment of HCV-patients with     normal renal function by combined pegylated IFN alfa plus ribavirin who fail to response to     IFN monotherapy has achieved a SVR rate of 28%. Based on the long-term favorable outcome in     dialysis patients who eradicate HCV, the aim of the study is to evaluate the efficacy and     safety of retreatment by pegylated IFN alfa-2a plus low dose ribavirin in dialysis patients     who fail to achieve HCV eradication by conventional or pegylated IFN alfa.   "
201962|NCT00491192|"     The purpose of our study is to verify wherever normothermia (achieved with diclofenac     administration) may improve intracranial pressure control and may limit secondary cerebral     damage thus positively influencing outcome in patients with acute cerebral damage admitted to     ICU.   "
201963|NCT00491218|"     The current outpatient evaluation for angina in low and intermediate risk patients typically     starts with a functional assessment for coronary ischemia. Exercise treadmill testing is     often selected as the initial diagnostic modality for coronary artery function. However,     exercise treadmill testing is limited by its moderate sensitivity and specificity, often     resulting in further cardiac resource utilization for patient risk stratification and     reassurance. With the advent of coronary multislice computed tomography (MSCT) angiography,     coronary artery anatomy can now be evaluated noninvasively. Despite its impressive     performance characteristics, the role of coronary MSCT angiography in the outpatient     evaluation of angina remains undefined.      CT-EXTRA compares the impact on patient safety and downstream resource utilization of a novel     initial diagnostic strategy employing the addition of coronary MSCT angiography to exercise     treadmill testing with a standard diagnostic strategy of exercise treadmill testing for the     ambulatory evaluation of low-intermediate risk patients with possible angina. The study is a     single center, prospective, non-blinded, randomized clinical trial. Men and women, age 18-70,     with a low to intermediate pretest probability of coronary artery disease who are referred     for an exercise treadmill test for angina are eligible. Subjects are randomized either to an     initial diagnostic strategy of exercise treadmill testing or exercise treadmill testing with     coronary MSCT angiography. Subsequent diagnostic testing and treatment are the discretion of     the referring physician. Subjects will be clinically followed for 24 months.      The clinical impact on patient safety and downstream clinical resource utilization of this     novel diagnostic strategy in which both coronary artery anatomy and function are initially     evaluated will be determined. The primary outcome is a composite endpoint consisting of     freedom from adverse cardiac events, further cardiac diagnostic testing, and future cardiac     clinical encounters. Secondary outcomes include the impact on the indiscriminate use of     coronary angiography, subject anxiety, depression, motivation for healthy behavioral change,     and satisfaction with diagnostic evaluation and use of antiplatelet and antilipid therapy.     Lastly, the cost effectiveness of the routine addition of coronary MSCT angiography in the     outpatient evaluation of possible angina will be determined.   "
201964|NCT00491231|"     The aim of the study is to evaluate whether orthostatic hypotension is associated with     nondipping hypertension.      Methods and patients: 400 subjects who are referred for 24hABPM will be filled questioner     regarding their medical background and medications. All patients will be subjected to     orthostatic test before connection to the 24 ABPM. The orthostatic changes in blood pressure     and heart rate will be correlated to the changes in blood pressure and heart rate from day to     night as recorded by the 24H ABPM.   "
201975|NCT00491374|"     This study will hope to show that the treatment of the patient's perennial allergic rhinitis     (PAR) using Nasonex® (mometasone furoate nasal spray) will result in improvement of the nasal     symptoms of PAR and of nighttime sleep-disordered breathing, thereby resulting in improved     sleep quality, less daytime sleepiness, improved daytime functioning, and improved quality of     life.   "
202010|NCT00491829|"     To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month     treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.      To evaluate safety and tolerability of flibanserin in such patients.   "
201965|NCT00491244|"     Chronic hepatitis C virus (HCV) infection is common in dialysis patients. Interferon     (IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in     immunocompetent patients. In dialysis patients, treatment with conventional or pegylated     interferon has also received much attention recently. Two meta-analyses evaluating the     efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic     response (SVR) rates were 37% and 33%, respectively; and the corresponding dropout rates were     17% and 29.6%, respectively.The efficacy and safety of pegylated IFN alfa-2a and 2b in     treating dialysis patients showed conflicting results, with a more favorable outcome of     patients treated with pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated)     than those treated with pegylated IFN alfa-2b (0.5-1.0 μg/week: SVR 12.5%, poorly tolerated.     Currently, IFN-based therapy to treatment HCV infection should be initiated in dialysis     stages, because the use of IFN in RT patients harbors high risks of acute graft rejection,and     have low response rates under the concomitant use of immunosuppressive agents.      Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the     general patients and achieve a higher SVR rate than IFN monotherapy, is considered     contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe     hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus     low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of     treatment. In addition, a recent study including 6 patients with combination of pegylated IFN     alfa plus low dose ribavirin also showed a SVR rate of 50%. In this study, treatment with     pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with     pegylated IFN alfa-2b plus low dose ribavirin (100% vs. 25%).      Based on the long-term favorable outcome in dialysis patients who eradicate HCV, and the     superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b     plus low dose ribavirin in treating dialysis patients with chronic hepatitis C, the aim of     the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose     ribavirin versus pegylated interferon alfa-2a alone in treatment naïve dialysis patients with     chronic hepatitis C.   "
201966|NCT00491257|"     This study is designed to generate clinical data as outlined in the Note for Guidance on     harmonization requirements for influenza vaccine marketing authorization by the European     Medicines Agency.      The objectives of the trial are:        -  To determine immunogenicity, of the inactivated, split-virion influenza vaccine Northern          Hemisphere (NH) 2007-2008 formulation in terms of the requirements of the Committee for          Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.        -  To describe the safety of the inactivated, split-virion influenza vaccine, NH 2007-2008          formulation.   "
201967|NCT00491270|"     To determine whether screening of pregnant women with history of previous preterm delivery or     with premature contractions for bacterial vaginosis using VS-SENSE, and treatment of positive     women will reduce the risk of spontaneous preterm birth.   "
201968|NCT00491283|"     A comparative study of different swab types used for collection of specimens for rapid     inluenza testing   "
201969|NCT00491296|"     PURPOSE: We determined whether Synergo therapy- intravesical chemotherapy instillation     combined with hyperthermia instillation is associated with elevated prostate specific antigen     (PSA). MATERIALS AND METHODS: We will treat 25 consecutive patients with bladder cancer with     a 6-week course of Synergo therapy, followed by cystoscopy at 6 weeks. Blood samples for PSA     determination will obtain before each synergo therapy application and at cystoscopy with each     patient also serving as a control.      Evaluating changes in PSA level in patients undergoing treatment with Synergo delivered local     hyperthermia combined with intravesical instillation of Mitomycin C for adjuvant treatment or     pt. with recurrent tu of bladder post TURT with BCGtreatment.   "
201970|NCT00491309|"     In Patients with rheumatic disease exercise training is a well established element of     therapy. In contrast patients with severe pulmonary hypertension are advised to avoid     physical exertion and must not perform exercise training. This study aims to evaluate the     effectivity and safety of a low-dose training program in patients with pulmonary hypertension     and rheumatic disease.   "
201971|NCT00491322|"     The purpose of this project is to determine if treating vitamin D deficiency decreases     insulin resistance and improves insulin secretion in healthy volunteers. Additionally, this     project will investigate if treating vitamin D deficiency affects a new phosphate-regulating     hormone called FGF-23.   "
201972|NCT00491335|"     Background:      The incidence of lung cancer is quite high among people with the human immunodeficiency (HIV)     virus. Frequent smoking may explain that cancer increase, given that 50% to 70% of     HIV-infected people are current smokers.      Recent research suggests that other factors may be involved as well. Smoking habits, such as     smoking earlier in life or smoking more cigarettes a day than others do, may have a role.     Also, HIV-infected smokers seem to have a greater risk of chronic obstructive pulmonary     disease (COPD). The association of HIV and COPD is important, because COPD itself is linked     to an increased risk of lung cancer.      About 1,600 subjects from the study known as ALIVE (AIDS Linked to the Intra-Venous     Experience), which began in 1988 in Baltimore, Maryland, will be given a detailed     questionnaire on smoking behaviors and lung cancer risk factors. They will also have     spirometry testing, to evaluate lung function.      Objectives:      To better characterize smoking habits and compare tobacco use among HIV-infected and     uninfected drug users.      To compare serum cotinine levels and spirometry results, as a marker of tobacco use and a     marker of damage to lung function, respectively.      Eligibility:      Patients 18 years of age and older who are in the ALIVE cohort.      Design:      Patients undergo the following procedures:        -  Completing a questionnaire on smoking history. Questions include age when smoking began,          periods of quitting smoking, average number of cigarettes per day for specific periods,          amount of each cigarette smoked, depth of inhalation, type of cigarette, nicotine          dependence, use of other smoked [Note: I would not mention that these drugs are illegal]          drugs, exposure to environmental tobacco smoke, past medical history, and recent          respiratory symptoms.        -  Spirometry testing. Patients are asked to breathe as deeply as possible and then rapidly          exhale into a tube. The forced expiration volume in 1 second reflects the average flow          rate during the first second, and it can be used to determine the degree of pulmonary          obstruction.        -  Blood samples. Tests measure levels of cotinine, a chemical made by the body from          nicotine. African American males, who constitute the majority of the ALIVE cohort,          participate in this test. Results would show how much tobacco smoke has recently entered          the body. For this test, researchers plan to evaluate 240 current tobacco smokers and          100 participants who report no recent cigarette use.   "
201973|NCT00491348|"     (1) to compare the differences of neural activation of pathological worry between     pre-treatment GAD patients and normal subjects; (2) to measure the differences of brain     activation on worry in GAD patients before and after duloxetine treatment   "
201974|NCT00491361|"     Background: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common childhood-onset     neuropsychiatric disorder (7.5% in Taiwan) with great impact on individual, family, and     society. The diagnosis of ADHD is mainly based on clinical interview of parents and children     with assistance of teachers' reports. Self-administered rating scales are useful for     screening, assistance of diagnosis, and measurement of symptom changes over time or due to     treatment effect. The goals of this study are to establish the norms and psychometric     properties of the Chinese version of teacher and parent forms of the Swanson, Nolan, and     Pelham, version IV (SNAP-IV) and the teacher, parent, and student forms of the Strengths and     Difficulties Questionnaire (SDQ) for future studies on ADHD in Taiwanese populations.      Subjects and Methods: This is a cross-sectional, school-based survey with a multi-stage     sampling method. The participants include a school-based sample of 3534 first to eighth     graders was recruited from four areas: Taipei City, Taoyuan County, Tainan City and Chiayi     County. Among them, 200students will be reassessed at 2-week interval for the test-retest     reliability study. The instruments comprise the Chinese version of Child Behavioral Checklist     (CBCL), SDQ, SNAP-IV, and Adult ADHD Rating Scale. The informants include student     participants older than 10 years old, their parents, and teachers. The main statistical     methods include Pearson correlation, intraclass correlation, Chronbach's α for internal     consistency, and mixed model to address lack of independence within the same classes and     schools.      Anticipated Goals: We expect that this study will reach the following objectives:        1. to obtain the primitive information about the prevalence of ADHD symptoms and          emotional/behavioral problems among children and adolescents in Taipei and Yun-Ling;        2. to enhance the awareness of school teachers and counselors about ADHD and other          behavioral/emotional problems among students;        3. to establish psychometric properties of the Chinese versions of SNAP-IV and SDQ for          future use in clinical, school, and research settings.   "
201976|NCT00491387|"     This is a study of patients with high blood pressure who are already treated with an     angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair     blood pressure control. The hypothesis is that addition of the beta-adrenergic receptor     blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic     nervous system, thereby further improving left ventricular filling and blood pressure     control.   "
201977|NCT00491400|"     The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial     function in patients with diabetes mellitus or the metabolic syndrome.   "
201978|NCT00491413|"     Erythropoietin (Epo) is a hormone normally found in the body that may protect brain cells     from damage due to lack of oxygen. This study will evaluate the safety of high-dose Epo in     infants who did not get enough oxygen during birth.   "
201979|NCT00491426|"     The purpose of this protocol is to provide a mechanism for the ongoing collection of blood     and urine samples in newborns that will be used to measure levels of antimicrobial products     used in the newborn population where there are limited pharmacokinetic data in either     premature or term infants.   "
201990|NCT00491569|"     Both GlyT-1 inhibitors and NMDA-glycine site agonists have been demonstrated to be beneficial     for chronic schizophrenia patients.      The purpose of this study is to compare efficacy and safety of add-on treatment of sarcosine,     a GlyT-1 inhibitor, and D-serine, an NMDA-glycine site agonist, in chronically stable     schizophrenia patients who have been stabilized with antipsychotics.   "
202038|NCT00492219|"     The purpose of this study is to determine if patients with a fixed-bearing or mobile-bearing     partial knee replacement perform functional activities differently than patients that have     had total knee replacement or healthy volunteers that have not had knee surgery. The     activities we are interested in include getting up out of a chair, stepping up and over a     small wooden box, and standing still with the knees straight and also bent to 45 degrees.   "
202039|NCT00492232|"     The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the     discontinuation of zolpidem in subjects with chronic insomnia.   "
201980|NCT00491439|"     Although epi-keratome laser-assisted in situ keratomileusis (Epi-LASIK), penetrating     keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic     retinopathy are surgeries commonly performed, the time-sequential, in vivo microscopic wound     healing process is not fully understood. The purpose of this study is to study the healing of     corneal wounds after Epi-LASIK, penetrating keratoplasty and pars plana vitrectomy with     corneal epithelial debridement for diabetic retinopathy by in vivo confocal microscopy, an     easily performed and non-invasive procedure. We plan to enroll 40 eyes of 40 patients in each     of these three surgeries. In Epi-LASIK, slit-lamp biomicroscopy, in vivo confocal microscopy,     and visual acuity are recorded before and 1, 3, and 7 days after surgery. The eyes are     examined weekly in the first month and at 3 and 6 months. For penetrating keratoplasty and     pars plana vitrectomy with corneal epithelial debridement, slit-lamp biomicroscopy, in vivo     confocal microscopy, and visual acuity are recorded before and weekly in the first month     after surgeries and at 3 and 6 months. Selected images of the corneal basal/apical surface     epithelia, stromal reactions and corneal endothelial conditions by in vivo confocal     microscopy are evaluated qualitatively for the cellular morphology and density.   "
201981|NCT00491452|"     Mitral valve repair for ischemic mitral regurgitation is performed primarily by annuloplasty.     There is some degree of late failure, which may be due in part to the type of ring employed.     We want to compare late results with mitral valve annuloplasty using flexible vs rigid     annuloplasty rings.   "
201982|NCT00491465|"     Randomized, controlled, open, comparative intervention study in two groups, each consisting     of 25 children with type 1 diabetes that will undergo twelve weeks of exercise program     (intensive arm) and twelve weeks of regular activity (non intensive arm) separated by four     week of washout period. The study will be conducted in a crossover manner: one group starting     with the intensive arm followed by the non intensive arm and vice versa. Blood glucose,     HbA1C, Fructosamine, 3 days continuous glucose monitoring system (CGMS), total daily insulin     dose, fasting lipid profile, body impedance and BMR will be measured. Self esteem and quality     of life questionnaires will be filled.   "
201983|NCT00491478|"     Repetitive behavior disorders are prevalent among people with severe mental retardation.     These disorders can interfere significantly with an individual’s daily functions. This trial     is part of a long-term project that has studied the biologic basis of and possible treatments     for repetitive behavior disorders. The trial will evaluate the effectiveness of two     medications, a selective serotonin reuptake inhibitor (SSRI) and an atypical antipsychotic,     in treating repetitive behavior disorders in people with mental retardation.   "
201984|NCT00491491|"     The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning     regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation     in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall     and disease-free survival.   "
201985|NCT00491504|"     The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works     to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting.     Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will     evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how     long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses,     3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's     opinion of the study drugs by asking different questions. This study is could last up to 53     days for some subjects.   "
201986|NCT00491517|"     Autosomal-Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal     disease, characterized by the progressive development of fluid-filled cysts in the kidney     leading to progressive loss of renal function and eventually to renal failure. It is     responsible for 8% to 10% of the cases of end stage renal disease (ESRD) in Western     countries. ADPKD progression is largely dependent on the development and growth of the cysts     and secondary disruption of the normal tissue. Renoprotective interventions in ADPKD - in     addition to achieve maximal reduction of arterial blood pressure and proteinuria and to limit     the effects of additional potential promoters of disease progression such as dyslipidemia,     chronic hyperglycemia or smoking - should also be specifically aimed to correct the     dysregulation of epithelial cell growth, secretion, and matrix interactions characteristic of     the disease. Genetically in the ADPKD three different genes are implicated (PKD1 85% of the     cases, PKD2 15% and probably PDK3 not yet identified). PKD1 gene encodes a protein named     polycystin-1 (PC1). Defect in PC1 lead to aberrant activation of the enzyme mTOR in the     epithelial cells of the renal tubules which eventually leads to abnormal proliferation of     these cells and cysts generation.      Sirolimus (Rapamycin) is an immunosuppressant mostly used for the management of kidney     transplant recipients. This drug by very specifically and effectively inhibiting mTOR, exerts     antiproliferative and growth inhibiting effects and could be extremely important for the     inhibition of cyst progression in ADPKD. Animal models of ADPKD have shown that short-term     treatment with sirolimus resulted in dramatic reduction of kidney size, prevented the loss of     kidney function, and lowered cyst volume density. Similarly, retrospective observations from     kidney transplant recipients have documented that sirolimus treatment reduced kidney volumes     by 25%, whereas there was no effect in patients not given the drug.      Overall, these findings provide the basis for designing a prospective study in ADPKD patients     aimed to document the efficacy of sirolimus treatment in preventing further increase or even     reducing the total kidney volume and the renal volume taken up by small cysts, eventually     halting kidney disease progression. It is a 6 month treatment with sirolimus compared to     conventional therapy in adult patients with ADPKD and normal renal function or mild to     moderate renal insufficiency.   "
201987|NCT00491530|"     The objective of the study is to assess the continued safety of the daily coadministration of     ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.   "
202009|NCT00491816|"     Primary Study Objective:      To assess the pathological complete response rate (pCR) with 4-6 cycles of neoadjuvant     chemotherapy plus erlotinib in patients with triple negative breast cancer.   "
201988|NCT00491543|"     ALT-2074 (BXT-51072) belongs to a class of drugs called glutathione peroxidase mimics.     ALT-2074 works by imitating a substance produced in various tissues in the body, which     prevents damage of the heart and blood vessels. Diabetic patients with a haptoglobin 2-2     genotype have poor cardiovascular clinical outcomes.      The purpose of this study is to assess the safety, the pharmacokinetic profile and     characterize the effect on biomarkers of inflammation and oxidative stress of repeat doses of     ALT 2074. Subjects must be diabetic, with evidence of coronary artery disease and a     haptoglobin 2-2 genotype   "
201989|NCT00491556|"     This study proposes to evaluate a pre-DHHS guideline of HAART initiation and then     de-intensification management strategy in adolescents with mild immunosuppression and compare     changes in CD4% from baseline to week 48 and then during de-intensification.   "
202040|NCT00492245|"     The present study was designed to evaluate the treatment of adenoviral corneal opacities with     PTK and mitomycin C.   "
201991|NCT00491582|"     This study aims at investigating the effect of growth hormone on lipid-content of muscle and     liver as well as visceral fat mass in relation to insulin sensitivity.      In addition, hormonal regulation and free fatty availability is assessed during a physical     exercise at 50-60% VO2max.      Finally, the value of physical exercise in diagnosing growth hormone deficiency is     investigated.      Hypothesis: 1) Lipid content of muscle and liver change with physical exercise and exercise     capacity and free fatty availability will influence these changes. 2)Growth hormone     replacement therapy will predominantly reduce visceral fat mass and increase free fatty     availability.      3)Free fatty availability during exercise will be reduced in growth hormone deficient     patients 4)Physical exercise may be an alternative way to diagnose growth hormone deficiency   "
201992|NCT00491595|"     The purpose of this research study is to examine the safety of specific soy components, known     as isoflavones, and to find out what effects (good and bad) these components have on tissues     that are sensitive to the hormone estrogen in healthy, post-menopausal women. Isoflavones are     compounds that occur naturally in soybeans and can be extracted to put in to capsule form or     add to foods. The capsule formulation being used in this study is considered an     investigational drug. This research is being done because many scientists believe that     isoflavones may play a role in the prevention of some kinds of cancer. While isoflavones have     been safely consumed in foods for centuries, we need to know if these soy components are safe     to take in higher doses when they are extracted from foods and provided in a supplement form.     We plan to test the safety and effects of the soy isoflavones known as genistein, daidzein     and glycitein.   "
201993|NCT00491608|"     The purpose of this study is to evaluate the safety and immune system response to recombinant     thrombin when used to control bleeding in spinal and vascular surgery.   "
201994|NCT00491621|"     Renal cancer is frequent and its diagnosis mainly dependant on imaging. More than 50% of     renal tumors are currently diagnosed without symptoms. However, 20% of small solid tumors are     benign and this percentage is much higher in atypical cystic tumors Bosniak II and III, where     76% and 59% are benign respectively. Determining the malignancy by imaging in these cases is     difficult and sometimes impossible. The fine needle aspiration (FNA) cytology or biopsy is     necessary. The diagnostic sensitivity and specificity with biopsy are high, but the potential     tumor contamination is a major risk. The FNA cytology is simple and safe, but its sensitivity     is about 50%. We are conducting a multicentric prospective study to add the molecular markers     in FNA cytology as a new diagnostic method in imaging-indeterminate renal tumors.      Four molecular markers including MN/CA9, vimentin, KIT, and S100A1 will be studied. These     four markers have been reported to have a differential diagnostic value in renal tumors.     MN/CA9 and vimentin are often found in conventional renal cancers. KIT is frequently     expressed in renal oncocytomas and chromophobe renal cancers. S100A1 may further distinguish     renal oncocytoma from chromophobe renal cancer. These markers will be analyzed by real time     polymerase chain reaction (RT-PCR).      The aim of this study is to evaluate the diagnostic performance of the association     cytology-molecular markers in imaging-indeterminate renal tumors (small solid tumors and     cystic tumors ≥ Bosniak III). About 156 patients will be included in five French clinical     centers including Saint-Etienne, Marseille, Grenoble, Toulouse, and Nancy.      The expected results will improve the preoperative diagnostic accuracy in renal tumors.   "
201995|NCT00491634|"     The study hypotheses is that the introduction of dose escalated treosulfan, in substitution     to busulfan, will reduce toxicity after allogeneic transplantation while improving     myeloablation and and disease control in patients with AML and MDS not eligible for standard     transplantation.   "
201996|NCT00491647|"     Background: Literature has documented that children with attention-deficit/ hyperactivity     disorder (ADHD) have difficulties in time management by manifesting with difficulties making     plans, organizing tasks and activities, and awaiting their turns. However, the studies     regarding time perception have been few as compared to those of neuropsychological measures     and there is no information about this topic in Chinese population. In view of this, we will     conduct a study to investigate the clinical and treatment aspects of time perception among     children and adolescent with ADHD.      Specific Aims:        1. to examine the developmental and gender effect on the performance in time perception;        2. to explore the deficit in time estimation, time discrimination, and time reproduction in          children and adolescents with ADHD as compared to normal controls;        3. to identify the association between ADHD symptoms and performance in time perception          tasks; and        4. to investigate the efficacy of MPH on the time perception measures among children and          adolescents with ADHD; Subjects and Methods: This protocol consists of two studies.          First, we will recruit 100 patients with DSM-IV ADHD, aged 9 to 16 years, and 100 school          controls. They and their parents will receive K-SADS-E interviews. All of them will have          complete assessments of time estimation, time discrimination, and time reproduction.          Their parents also report on SNAP-IV and CPRS-R:S. The 2nd assessments will be performed          3 months later after the subjects received treatment at outpatients.      Anticipated Results: We anticipated that the ADHD group will have poorer time perception,     particularly in difficult tasks, and the impairment will be reduced after treatment with     medication   "
201997|NCT00491660|"     Ventilator-associated pneumonia (VAP) is the leading cause of death among all nosocomial     infections in ventilated patients. Once intubated, the risk of pneumonia in hospitalized     patients is increased 3-10 fold; almost 90% of hospital-acquired pneumonia occurs in     intubated patients. Each episode of VAP is associated with 7-9 days of additional hospital     stay with an estimated increase in cost of care that exceeds $40,000. In an effort to control     VAP, several studies were conducted including oral and gastric decontamination with     antibiotics, rotation of the bed, and local instillation of antibiotics via endotracheal     tube. Despite such efforts, VAP is still a major complication for intubated patients.      The effect of gravity on bacterial colonization of the endotracheal tube was recently     explored in an animal study that was conducted at the United States National Institutes of     Health. The study demonstrated a significantly lower tracheal colonization and decreased     alveolar contamination in ventilated sheep when positioned on their side allowing for     tracheal drainage by gravity. Such findings have not been validated in clinical practice and     the need for clinical trials studying the effect of lateral positioning have been demanded.     Therefore, we aimed our randomized controlled trial to test the hypothesis that intubated     infants who are positioned on their side are at lower risk for contracting microbes in their     trachea when compared to those in a supine position.   "
201998|NCT00491673|"     There is increasing evidence that primary hemiarthroplasty is the treatment of choice for     displaced femoral neck fractures in the elderly      No definite conclusions have been made in regards to what kind of arthroplasty is favourable      Cemented implants are associated with increased risk of perioperative cardiovascular     incidents and increased mortality.      Cementless implants are associated with increased postoperative pain and decreased walking     ability.      This study investigates the differences between one well-documented cemented femoral stem and     one well-documented uncemented femoral stem. Previous studies have mostly used uncemented     stems with different designs.      Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year and 5     years   "
201999|NCT00491686|"     The purpose of this study is to determine whether treatment with AZD6765 will have an     antidepressant effect with patients who have treatment resistant depression.   "
202000|NCT00491699|"     The purpose of this study is to determine the safest dose of XL999 and how well subjects with     Non-Small-Cell Lung Cancer tolerate XL999. XL999 is a small molecule inhibitor of multiple     kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell     growth, formation of new blood vessels (angiogenesis), and metastasis.   "
202001|NCT00491712|"     The management of neovascular glaucoma (NVG) is a challenge for the ophthalmologist and     surgery is frequently needed to control IOP. The success rates of a drainage device is     usually lower in NVG than in other forms of glaucoma. Triamcinolone intra-vitreous injections     acetate has been used to treat macular edema secondary to diabetic retinopathy and central     retinal vein occlusion and also to control inflammation in ophthalmologic surgeries.      In the present study we will compare the outcome and complications of Silicone Ahmed Valve in     GNV eyes with and without intra-vitreous triamcinolone injection.   "
202002|NCT00491725|"     This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety     of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes     inadequately controlled with OAD (oral anti-diabetic drugs).   "
202003|NCT00491738|"     This is a Phase II, multicenter, randomized, blinded, placebo-controlled study designed to     evaluate the safety and efficacy of combining bevacizumab with sunitinib relative to placebo     with sunitinib in patients with metastatic RCC who have not received prior systemic therapy     for metastatic disease. The study will enroll approximately 100 patients at approximately 20     centers in the United States.   "
202004|NCT00491751|"     This study will seek to determine whether non-invasive measures of endothelial function have     utility as surrogate markers of cardiovascular risk in patients with peripheral arterial     disease undergoing vascular surgery. Measurements of endothelial function will be made before     and after initiation of atorvastatin, ascorbic acid, or placebo therapy during the     pre-operative period. We will then examine cardiovascular events following surgery. We     hypothesize that patients who have no improvement in endothelial function will have increased     cardiovascular risk compared to patients with improvement in endothelial function.   "
202005|NCT00491764|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of oral     administration of four dosing regimens of posaconazole relative to placebo and terbinafine,     in the treatment of toenail onychomycosis.   "
202006|NCT00491777|"     The new NcIQ thoracic impedance monitor is based on the predicate device, the IQ101. The new     model uses the same 3-dimensional signal averaging as the original device, but also include     second radio frequency signal to permit the device to work “wirelessly”, i.e., without     electrode lead attachments to the patient. This study seeks to 1) validate the use of the new     device and confirm the correlation of the IQ101 and NcIQ. 2) Evaluate the ease of the new     device.      The new IQ2 thoracic impedance monitor is based on the predicate device, the IQ101. The new     model uses the same 3-dimensional signal averaging as the original device, but with smaller     housing and updated operating software. This study seeks to 1) Validate the use of the new     device and confirm the correlation of the IQ101 and IQ2. 2) Compare the ease of the devices.   "
202007|NCT00491790|"     The purpose of this study is to determine if montelukast, in addition to standard treatment     is helpful in treating patients ages 2-5 who are in the hospital because of status     asthmaticus.   "
202008|NCT00491803|"     Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of     pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric     oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries     of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary     disease (COPD), we hypothesized that sildenafil might improve pulmonary hemodynamics and     increase exercise tolerance in this condition. However, in COPD sildenafil may also impair     gas exchange due to the inhibition of pulmonary hypoxic vasoconstriction. The research     project is aimed to evaluate these effects.      It is a prospective, randomized, double-blind study to evaluate the acute effects of a single     dose of 20 or 40 mg of sildenafil on gas exchange and pulmonary hemodynamics. Subjects: 20     patients (10 in each group). Measurements: pulmonary hemodynamics, arterial blood gasses and     ventilation-perfusion distributions; at rest and during sub-maximal exercise.   "
202035|NCT00492167|"     RATIONALE: Beta-glucan may stimulate the immune system and stop tumor cells from growing.     Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Giving beta-glucan together with monoclonal antibody     3F8 may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when     given together with monoclonal antibody 3F8 in treating patients with metastatic     neuroblastoma.   "
202036|NCT00492193|"     The purpose of this trial is to gather information on the postoperative recovery time and     hospital length of stay experienced by patients having laparoscopic surgeries. This trial     will also collect data on daily surgical pain and pain medication and how it relates to     recovery after surgery. In addition, the investigators will collect data on the use of pain     medication and laxatives in patients following laparoscopic large bowel resection.   "
202037|NCT00492206|"     This is an open label, phase II study in which cetuximab with concurrent thoracic     radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab     will be administered to subjects with locally advanced NSCLC.   "
202011|NCT00491842|"     This study will examine the ways in which people reveal their status as a carrier of     Huntington s disease (HD) or of being at risk for the disease. It will explore factors that     influence decisions about disclosure and how disclosure is made to family members, partners,     and close friends.      HD is an inherited, progressive disease. It causes nerve degeneration, motor disturbance,     loss of awareness, and psychiatric symptoms. Currently, no effective treatment is available     to prevent or delay HD progression. The mean age of onset is 35 to 44 years, and the median     survival rate after onset is 15 to 18 years. HD affects about 1 in 10,000 people in the     United States, so about 30,000 have HD and more than 200,000 are at risk. Predictive testing     for HD has been available since 1993. It can be a life-changing event to learn of being at     risk for HD. Disclosure has been studied among people with HD and other diseases, but     knowledge about the extent of nondisclosure and disclosure is limited. There is evidence that     a person s psychological adaptation to AD may be a factor. Adaptation involves processes that     help a person search for meaning in what has happened, attempt to gain control of his or her     life, and improve self-esteem in light of the threatening situation.      Participants ages 18 and older who have had a positive genetic test result more than 6 months     earlier regarding HD or who have a family history of HD but no predictive testing and who do     not have symptoms of HD may be eligible for this study. Recruitment is done through HD     clinics, support groups, and online websites and mailing listservs. About 260 people will be     in the study. Participants will complete a survey taking 30 to 40 minutes to do. Two survey     versions are available: for those who are gene carriers and for those at risk. Participants     are asked to complete the version applying to them. The survey can be done online or through     a hard copy to complete at home and send to NIH. This survey is anonymous.      Participants will list the adults with whom they have a relationship and up to 10 people they     interact with. They will indicate those who know about the HD gene or risk status. They will     also list those to whom they have personally made disclosure. The goal is to distinguish if     knowing the status or the act of disclosure is more important. Questions also involve     discussing the inheritance and features of HD, and participants feelings or concerns about HD     gene or risk status. Participants will be asked about their first disclosure experience, most     recent experience of it, and timing of disclosure the time between learning of HD status and     telling another person about it. There are also questions on decisions of nondisclosure,     negative and positive aspects of disclosure for participants, and what health care     professionals can do to help participants disclosure decisions.   "
202012|NCT00491855|"     The goal of this clinical research is to learn acceptable dosages of paclitaxel, oxaliplatin,     and Avastin (bevacizumab) that can be given in combination to patients with advanced     peritoneal carcinomatosis. The safety of this drug combination will also be studied.   "
202013|NCT00491868|"     This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of     intravenous injections of R744 in renal anemia patients on Hemodialysis patients.   "
202014|NCT00491881|"     There is much evidence that a reduction in dietary salt intake lowers blood pressure in     hypertensive individuals, however few have looked at effect of 'no added salt diet' and     modest salt intake on total restriction of sodium intake with especial attention to very     exact surrogate of urinary sodium excretion. Our study demonstrates that a modest reduction     in salt intake from regular level of 10 - 12 g per day to the recommended level of 5 - 6 g     per day lowers blood pressure by 12.1/ 6.8 mmHg at day time and 11.1/5.9 mmhg at night     time.However only 35% of patients reach to the goal of sodium restriction of diet(below 100     meq/dl in 24 hours urine.It means even modest salt restriction can dramatically decrease     blood pressure with no added salt diet.   "
202015|NCT00491894|"     This is an open-label clinical research study of an oral glycopyrrolate liquid for the     treatment of chronic moderate to severe drooling in patients with cerebral palsy or other     neurological conditions. Patients participating in the study will receive oral glycopyrrolate     liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout,     screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration     period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration     Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02     mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal     individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is     reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is     lesser. Optimal dose for each patient is the dose at which he/she is receiving the maximum     benefit from the study drug (greatest improvement in drooling) while experiencing minimum     side effects. All patients will receive close attention by study staff throughout the study.   "
202016|NCT00491907|"     The randomized, double-blind, placebo-controlled study aim to evaluate the effect of 1-month     therapy with folic acid (5 mg/day) on endothelial function and baroreceptor function in     patients with heart failure.      Endothelial function will be studied non-invasively with flow-mediated dilation while for     eveluating baroreceptor function sympathetic nervous system activity will be measured     directly with microneurography in baseline condition and during infusion of     sodium-nitroprusside.   "
202017|NCT00491920|"     Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What     dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis     that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a     randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women     with T-score <= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and     vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week,     while the other half will have placebo. The study period is one year.   "
202018|NCT00491933|"     The purpose of this study is to evaluate the value of Quantiferon-TB Gold (QFT-G) assay in     the screening for latent tuberculosis infection (LTBI) in rheumatologic patients due to start     or on treatment with TNFα antagonists. The results of QFT-G will be compared to tuberculin     skin testing (TST) and correlated to clinical and demographic data. The study hypothesis is     that the inclusion of QTF-G in the screening strategy will allow a more accurate assessment     of LTBI infection.   "
202019|NCT00491946|"     To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in     children with cancer.   "
202034|NCT00492154|"     The fractures of distal forearm are the most common trauma in children. Sometimes one of the     bones becomes shortened as a result of fracture fragments overlap. When some amount of     shortening exists, concern regarding relationship of distal radio-ulnar joint (DRUJ) arises.     The common opinion is expressed in one of the textbooks and is represented by one sentence,     which usually one bone shortening is well tolerated, probably does not cause a problem, and     does not have clinical significance. However, pathology of ulna plus or minus variants is     well described and may cause ulno-carpal abutting syndrome or radiocarpal pain. This concern     may lead to more aggressive approach in treatment of a fracture, with attempts to make an     equal bone length. We did not find in the literature study that investigates this problem. We     postulate that obvious shortening of one bone may cause an inequality of DRUJ and can be     clinically significant.   "
202129|NCT00486746|"     The main objective of the study is to determine whether a supervised lifestyle intervention     including individualized dietary counseling could be a curative treatment for patients with     mild OSA.   "
202020|NCT00491959|"     Since cultivated autologous oral mucosal epithelial sheets on amniotic membrane have been     reported to have good clinical results in treating patients with ocular surface disorders in     both human or animal studies, and such technique has not been used in our hospital, the main     purpose of this study is to use these cell sheets to treat patients with severe surface     disorders, which include limbal insufficiency induced corneal surface problem, and     symblepharon caused by severe conjunctival epithelial insufficiency. We will first choose     patients who meet the surgical criteria, and these patients need to receive dental     examination three months before surgery. Two weeks before transplantation, the oral mucosa     tissue will be obtained by a dentist and the oral mucosal epithelial cell sheets will be     cultivated on amniotic membrane until reaching confluency and stratification. During the     transplantation surgery, the abnormal fibrovascular tissues on the ocular surface will be     removed. The areas of symblepharon will also be released. The cultivated oral mucosal cell     sheets will be transplanted on the denuded corneal surface or the scleral surface of the     symblepharon area. Therapeutic contact lenses will be applied after surgery. After operation,     the patients will be admitted for about two weeks. After discharge, the patients need to     receive regular follow up weekly during the first two months, followed by biweekly follow up     until postoperative 6 months. Afterward, the patients need to receive monthly follow up until     postoperative 2 years. During the follow up, the data of the patients' visual acuity,     intraocular pressure, slit lamp biomicroscopic findings, and in vivo confocal microscopic     data will be obtained. The project plans to start from July 1st 2007 until June 30th 2010. We     plan to enroll totally 20 patients.   "
202021|NCT00491985|"     This is an open, randomized, multicenter clinical trial.      Objectives:        -  To describe the safety profiles during the 21 days following each primary and booster          injection.        -  To describe the immune response 21 days after each primary and booster injection of each          formulation.        -  To describe the antibody persistence after the first vaccination   "
202022|NCT00491998|"     The purpose of the study is to determine if the pharmacokinetic profile of V1512 is similar     or better than existing medications for the treatment of Parkinson's Disease   "
202023|NCT00492011|"     The purpose of this study to determine the degree to which ramelteon, once daily (QD), can     reduce the insomnia symptoms associated with rapid, eastward travel across 5 time zones.   "
202024|NCT00492024|"     The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day     treatment of adult patients with acute bacterial sinusitis and to measure the amount of time     it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of     acute bacterial sinusitis, therefore in this study Avelox is considered an investigational     drug. In this study Avelox will be compared to placebo.   "
202025|NCT00492037|"     Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic     hyponatremia   "
202026|NCT00492050|"     The main goal of this clinical research study is to learn if Velcade ® (bortezomib) given     with rituximab can help to control WM. This drug combination will allow researchers to     collect your stem cells in case it is possible to transplant the stem cells as treatment if     your WM gets worse. Researchers will also look at the safety and tolerability of this drug     combination followed by treatment with other drug combinations.   "
202027|NCT00492063|"     The present study aims to evaluate the safety and immunogenicity of the new influenza subunit     vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly     subjects.   "
202028|NCT00492076|"     The purpose of this study is to determine whether a short course of subcutaneous     immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in     control medication.   "
202029|NCT00492089|"     Bevacizumab may reduce CNS side effects caused by radiation therapy. This randomized phase II     trial is studying how well bevacizumab works in reducing CNS side effects in patients who     have undergone radiation therapy to the brain for primary brain tumor, meningioma, or head     and neck cancer.   "
202030|NCT00492102|"     The purpose of this study is to determine the pharmacokinetics (PK) of montelukast     (Singulair) in very low birth weight (VLBW) infants at risk for developing bronchopulmonary     dysplasia (the need for supplemental oxygen). The investigators' long-term hypothesis is that     inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation,     remodeling and the incidence of bronchopulmonary dysplasia (BPD).   "
202031|NCT00492115|"     Patients with sleep disordered breathing (SDB), also called sleep apnea, experience nighttime     disrupted sleep and, because they stop breathing for short periods during the night, do not     get sufficient oxygen to their brains. This can frequently result in daytime impairments     including difficulties with memory. The state-of-the-art treatment for SDB is Continuous     Positive Airway Pressure (CPAP). Many non-demented SDB patients who are successfully treated     with CPAP show improvement in memory and other cognitive functions. Data have shown that     patients with Parkinson's disease have a high rate of SDB. Patients with Parkinson's disease     also often have problems with memory. This study will test the effects of treating SDB among     patients with Parkinson's disease and SDB. Specifically, the study will test the effect of     CPAP treatment on SDB and sleep; the effect of CPAP treatment on daytime sleepiness,     cognition, overall quality of life and mood; the effect of CPAP treatment on the frequency of     symptoms of REM behavior disorder and restless legs syndrome; the effect of continued CPAP     use (beyond the six weeks of the study) on SDB, sleep, cognition, mood and quality of life;     whether the study-partner feels that CPAP improves the patient's sleep, mood and overall     functioning; whether study-partners feel that their own sleep, mood and overall functioning     improve as the patient's sleep improves both during the 6-week protocol and at follow-up for     those opting to continue using CPAP.   "
202032|NCT00492128|"     The purpose of this study is to compare the effect and safety of the antihypertensive     combination therapies between losartan/amlodipine and fixed dose drug of     losartan/hydrochlorothiazide.   "
202033|NCT00492141|"     Primary Objectives:        1. To determine the feasibility and toxicity profile of administering liposomal          9-Nitro-20-(S)-Camptothecin (L9-NC) by aerosol alone and in combination with          temozolomide.        2. To determine the effectiveness of L9-NC given by aerosol in combination with          temozolomide in patients with solid tumors involving the lungs.   "
202041|NCT00492258|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib after     surgery may kill any tumor cells that remain after surgery. It is not yet known whether     sorafenib is more effective than a placebo in treating kidney cancer.      PURPOSE: This randomized phase III trial is studying sorafenib to see how well it works     compared with a placebo in treating patients at risk of relapse after undergoing surgery to     remove kidney cancer.   "
202042|NCT00492271|"     The purpose of this study is to study the safety of single doses and multiple doses of     Friulimicin B in healthy volunteers. The level of Friulimicin B will be measured in the     subjects blood and urine. One part of the study will assess if Friulimicin B in the plasma of     subjects has activity against bacteria.   "
202043|NCT00492284|"     The objective of this study is to determine if combination therapy (reduced-fluence Visudyne     followed by Lucentis [within 2 hours] or either of two regimens of reduced-fluence Visudyne     followed by Lucentis-Dexamethasone triple therapy [within 2 hours]) reduces retreatment rates     compared with Lucentis monotherapy while maintaining similar vision outcomes and an     acceptable safety profile.   "
202044|NCT00492297|"     The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY     43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC).     DTIC is the current standard chemotherapy drug given for melanoma that has spread through the     body. Although this drug can be effective on its own and is generally well tolerated, not all     patients will benefit, so there is a need to test new drugs and drug combinations for     treating melanoma.   "
202045|NCT00492310|"     The purpose of this study is to examine the feasibility, acceptability and initial     effectiveness of adding yoga to a traditional, group-based treatment for smoking cessation     for women smokers.   "
202046|NCT00492323|"     The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200     mg of RWJ-333369 given twice daily compared with placebo in the treatment of postherpetic     neuralgia.   "
202047|NCT00492336|"     This is a study of a new medication for the treatment of cognitive impairments (thinking     difficulties) and negative symptoms in people with schizophrenia. The new medication is     rasagiline. Rasagiline is a drug which has been approved by the Food and Drug Administration     for the treatment of Parkinson's disease. It is used to treat cognitive problems.   "
202048|NCT00492349|"     The principal aim of the project is to conduct an off-label adjunctive clinical trial     evaluating varenicline as a treatment for core neurobiological and clinical deficits in     schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.   "
202049|NCT00492362|"     Randomized controlled trial comparing effects of ergometer exercise during hemodialysis to     effects of pedometer use outside of hemodialysis on exercise capacity, functional status,     quality of life and adequacy of hemodialysis.   "
202050|NCT00492388|"     To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the     treatment of breakthrough pain in cancer patients.   "
202051|NCT00492401|"     This phase II trial is studying how well decitabine works in treating patients with     previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing   "
202052|NCT00492414|"     Panic disorder(PD)is a disabling psychiatric condition associated with significant impairment     in psychosocial, occupational functioning and quality of life, as mentioned by mogotsi et al.     So, most patients with panic disorder suffers from the consequences of the impairment in     occupational function. This impairment is not only individual problem, but also social one.     Since productivity is very important item required to employees, lost productive time among     workers with psychiatric illness should be reduced by the proper management. But few data     were reported in this field by now.   "
202053|NCT00492427|"     This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of     subcutaneous R744 in renal anemia patients on Predialysis.   "
202054|NCT00492440|"     RATIONALE: Interleukin-7 may stimulate the white blood cells to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in     treating patients with metastatic melanoma or locally advanced or metastatic kidney cancer.   "
202059|NCT00492505|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as tamoxifen and cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving sorafenib together with     tamoxifen and cisplatin after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib     together with tamoxifen and cisplatin works in treating patients with high-risk stage III     melanoma.   "
202060|NCT00492518|"     Several studies demonstrated a significant reduction of contrast-induced nephropathy (CIN;     definition: increase in serum creatinine of >=0.5mg/dl and/or >=25% increase within 48h after     contrast-medium) by acetylcysteine (A) or theophylline (T). However, the results are     contradictory. Therefore, it was the aim of our double-blind study to compare the effects of     A, T, a combination of A and T (A+T), and placebo (P).   "
202095|NCT00492973|"     Prior to surgery, a pharmacist will randomly assign participating patients to one of two     groups. One group will get an injection in the knee during surgery that contains medications     to limit pain and an antibiotic. A second group will get an injection in the knee during     surgery that contains the same pain medications and antibiotic along with a corticosteroid to     control inflammation. Corticosteroids are anti-inflammatory medications, not to be confused     with muscle-building anabolic steroids you may have heard about in the news. Each patient     will have an equal chance of being in either of the two groups. This study will test the     safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation     following total knee replacement.   "
202152|NCT00487045|"     This study is being conducted to evaluate an investigational instrument called the HEM-AVERT     Perianal Stabilizer and its efficacy in reducing the occurrence or severity of hemorrhoids     and thrombosed external hemorrhoids (TEH) which commonly occur during vaginal delivery.   "
202061|NCT00492531|"     This study will examine whether the drug sildenafil can lower blood pressure in the pulmonary     artery (the blood vessel that leads from the heart to the lungs) in patients with sickle cell     disease and pulmonary hypertension (high blood pressure in the lungs). It will see if this     treatment can reduce disease complications, such as shortness of breath, pain crisis,     pneumonia, and increase survival.      Patients 12 years of age and older with sickle cell disease and pulmonary hypertension may be     eligible for this study. Participants are randomly assigned to receive sildenafil or placebo     (sugar pill) for 16 weeks. Before starting treatment, patients have baseline studies,     including a pregnancy test for females of childbearing age; a chest x-ray; pulmonary function     tests to measure how much air the patient can breathe in and out; an echocardiogram (heart     ultrasound); a 6-minute walk test to measure exercise capacity; a quality-of-life assessment     and a pain inventory. Patients with moderate to severe pulmonary hypertension undergo heart     catheterization to evaluate the severity of hypertension before beginning sildenafil therapy.      During treatment, patients are monitored with the following:        -  Blood tests: weeks 6, 10 and 16.        -  Echocardiogram: weeks 6 and 16.        -  6-minute walk test: weeks 6, 10 and 16.        -  Measurements of weight, blood pressure and heart rate: weeks 6, 10 and 16.        -  Pregnancy test for women of childbearing age: weeks 6, 10 and 16.        -  Pain questionnaire once a day for a week: weeks 6 and 1.0        -  Quality-of-life questionnaire: week 16.        -  Heart catheterization: week 16 for patients with moderate to severe hypertension.      At the end of the 16-week period, patients may opt to continue to receive sildenafil and     monitoring in an open-label phase of the study for up to 1 year.   "
202062|NCT00492544|"     Human papillomavirus (HPV) infection has been established as a necessary cause of cervical     cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common     oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers.     In previous trials, the vaccine has been found to be efficacious in the prevention of     incident and persistent HPV-16/18 infections and associated cytological abnormalities. HPV     vaccination should ideally be performed before onset of sexual activity. Previous studies     showed that GSK Biologicals' HPV vaccine 580299 is safe and immunogenic when administered to     European, Asian, Latin American and Australian pre-adolescents and adolescents. Here, we aim     to assess the immunogenicity and safety of the GSK Biologicals' HPV vaccine 580299 in healthy     Japanese pre-adolescent and adolescent female subjects aged 10-15 years. The Protocol Posting     has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
202063|NCT00492557|"     The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to     prevent pneumococcal diseases such as meningitis (inflammation of the brain lining),     septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent     influenza vaccine (TIV) is frequently given to adults, it is important to show that both     vaccines can safely be given together without affecting the immune response (body's ability     to protect against disease).   "
202064|NCT00492570|"     This study is being done to increase awareness for early therapy with Avonex for Multiple     Sclerosis (MS) and the cognitive dysfunction that accompanies MS, and to record safety data     for Avonex.   "
202065|NCT00492583|"     The purpose of this study is to determine if the consumption of a yogurt drink containing a     high dose of probiotics decreases absences, due to illnesses, in daycare centers for children     between the ages of 1 and 3.   "
202066|NCT00492596|"     Over 11 million women in the United States suffer from stress urinary incontinence (SUI), the     involuntary leakage of urine during routine physical activities such as laughing, coughing,     exercising, or sneezing. SUI affects women of all ages and can result in significant     emotional distress. The purpose of this study is to evaluate a non-surgical, investigational     treatment intended to reduce or eliminate urine leakage due to stress urinary incontinence.   "
202067|NCT00492609|"     A poor outcome in anterior cruciate ligament (ACL) reconstruction is often related to tunnel     position. The researchers believe that improving the accuracy of tunnel position will lead to     an improved outcome in ACL surgery. The researchers' purpose is to perform a controlled study     on a series of 500 patients in two groups: group I (250 cases) using conventional     instrumentation and group II (250 cases) using navigation (Surgetics ACL Julliard protocol).   "
202068|NCT00492622|"     The purpose of this study is to compare the blood drug levels of two prescribed medications,     immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to     determine which drug is better absorbed in patients with a slow stomach emptying     (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug     omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium     bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a     protective coating. Immediate-release omeprazole suspension may have a more rapid     pharmacokinetic profile and greater overall drug absorption in gastroparesis.   "
202069|NCT00492635|"     A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed'     (immediately before intended sexual activity) compared to placebo, to evaluate its     tolerability and if it can help in recovery of erections after a nerve sparing radical     prostatectomy.   "
202224|NCT00495105|"     To prevent excess increases in blood pressure in children by providing two servings of dairy     foods as snacks daily at school. We hypothesize that children who receive the two dairy     snacks will exhibit significantly less of an increase in blood pressure over six months as     compared to control children.   "
202070|NCT00492648|"     The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12     post-vaccination in the primary study. In the extension studies presented here, the     persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months     after the first vaccination in young and elderly adults who received the GSK324332A vaccine.     This protocol posting deals only with objectives & outcome measures of the extension phase at     Months 30 and 42. No new recruitment will be done in these extension phases of the primary     study. No vaccines are administered in this phase of the study.   "
202071|NCT00492661|"     The purpose of this trial is to investigate whether a combined dietary and exercise     intervention, added to standard care, reduces the expected frequency of insulin resistance in     renal (kidney) transplant recipients on tacrolimus.   "
202072|NCT00492674|"     Introduction: Total knee arthroplasty (TKA) is a consensus treatment for end-stage knee     osteoarthritis. The peri-operative rehabilitation is an important part of the outcome of such     procedure. Previous studies have shown that there is correlation between both pre-operative     functional status and the intensiveness of the post-operative rehabilitation to the post     operative function of the patient.      An important part of the peri-operative rehabilitation in TKA is the neuromuscular control     re-education.      A novel biomechanical device comprising of four individually calibrated elements attached     onto foot-worn platforms was recently developed. This device is capable of bringing the     patient to a functional bio-mechanical alignment during standing and walking, while     simultaneously strengthening dynamic stabilizers and training neuromuscular control by means     of controlled biomechanical perturbations.      Objectives: The aim of this study is to evaluate the influence of pre and post operative     training with the biomechanical device mentioned above on the functional outcome and quality     of life of patients undergoing TKA.      Design and Setting: Randomized, controlled and double blind prospective trial      Patients: 120 patients who are candidates to TKA      Interventions: Patients will randomly assigned into five groups (active, sham and control)     and will followed for fourteen months (two moths pre-operative and twelve months     post-operative). All groups will undergo post-operative physical therapy (PT) according to     the standard guidelines. In addition, the active groups will be treated with the device and     its four biomechanical elements that had been individually calibrated for each patient. The     sham group will be treated with the same device; however, the biomechanical elements will     have zero perturbation and will be positioned along the central longitudinal line of the     shoe-platform. The control group will be treated only according to the standard     post-operative protocol.      The five groups:        1. Pre- operative BD training and post-operative PT and BD training        2. Pre- operative sham training and post-operative PT and BD training        3. Pre- operative sham training and post-operative PT and sham training        4. No pre-operative training (according to the guidelines in Israel) and post-operative PT          and BD training.        5. No pre-operative training (according to the guidelines in Israel) and post-operative PT          and sham training.      Primary Outcome Measures: Spatio-temporal measures (recorded by Gait-Rite™) and the     Aggregated Locomotor Function (ALF) assessment.      Secondary Outcome Measures: Pain and function questionnaire measured by the Western Ontario     and McMaster Osteoarthritis Index (WOMAC) and Quality of life will be evaluated by the SF-36     quality of life questionnaire.      Measurements will be taken at day-1 (two months before the TKA) and at four more stations: 1     Week prior to the TKA, Three months post the TKA, six months post the TKA and twelve months     post the TKA   "
202073|NCT00492687|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Tamoxifen may     make tumor cells more sensitive to radiation therapy and chemotherapy. Giving radiation     therapy together with temozolomide, tamoxifen, and carboplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving radiation     therapy together with temozolomide, tamoxifen, and carboplatin works in treating patients     with malignant gliomas.   "
202074|NCT00492700|"     This study is intended to find out whether treatment with rosiglitazone improves the state of     the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).   "
202075|NCT00492713|"     Dark chocolate is one of the richest sources of polyphenols though it has been hypothesised     that the bioavailability of epicatechin from milk chocolate was reduced compared to dark. The     primary outcome measure is to compare plasma polyphenol levels after consumption of 3     chocolates (2 milk, 1 dark) while the secondary outcome measures are to characterise the time     course of polyphenols in the blood and to investigate individual variation in Tmax and Cmax     for use in future studies.   "
202076|NCT00492726|"     A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with     intra-abdominal infections.   "
202077|NCT00492739|"     Varicella is a vaccine-preventable disease, which can be severe in immunosuppressed children.     Currently, the (live) vaccine is not recommended in pediatric orthotopic liver transplant     recipients. Furthermore, protection due to naturally acquired immunity to VZV or     post-immunization isn't well described in this population.The questions asked are:        -  What is the influence of the immunosuppression required after orthotopic liver          transplantation (OLT) on the maintenance of VZV-specific immunity elicited by wild-type          varicella infection before OLT transplantation?        -  What is the influence of the immunosuppression required after OLT on VZV-specific          immunity elicited by varicella immunization before OLT transplantation?        -  What is the influence of the residual immunosuppression at ≥ 12 months after OLT          transplantation on the induction of VZV-specific B and T cell responses elicited by VZV          vaccination after OLT transplantation?        -  What is the influence of the residual immunosuppression at ≥ 12 months after OLT          transplantation on the persistence / waning of B and T cell responses elicited by VZV          vaccination?   "
202078|NCT00492752|"     The purpose of the study is        -  Find out if patients receiving Sorafenib will live longer        -  Find out if Sorafenib has any effect on patient reported outcomes        -  Find out if Sorafenib prevents the growth or shrinks liver tumors and / or their          metastases        -  Determine the pharmacokinetics (PK) in patients with liver cancer   "
202079|NCT00492765|"     This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a     in patients with Multiple Sclerosis.   "
202080|NCT00492778|"     This randomized phase II trial studies radiation therapy and cisplatin to see how well they     work compared with radiation therapy alone in treating patients with endometrial cancer that     has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill     tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. It is not yet known whether giving radiation therapy together     with cisplatin is more effective than radiation therapy alone in treating patients with     endometrial cancer.   "
202110|NCT00486499|"     hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor     eradication.      A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7     to 9 and/or PSA 10–20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus     Pd-103 (124 Gy).   "
202111|NCT00486512|"     The purpose of the study is to investigate if long-term treatment with three known drugs     (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents     recurrence of colorectal adenomas.   "
202096|NCT00492986|"     Purpose of the study:      The purpose of this study is to make sorafenib available for patients with advanced Renal     Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring     second line treatment), and who do not have access to or are not eligible for other clinical     trials with sorafenib and who may benefit from treatment with sorafenib.      Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a     single agent. Patients may continue treatment until Disease Progression, intolerable     toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any     further from treatment.      Overall, participation in the study will help determine the following:        -  Find out if patients receiving Sorafenib will live longer        -  Find out if Sorafenib helps to slow the worsening of kidney cancer        -  Find out if Sorafenib has an effect on the tumours   "
202081|NCT00492791|"     The endoscopic capsule is a new tool for exploration of the small intestine. The superiority     of this technique on the radiological conventional examinations was shown in Crohn's disease.     However no standardization of the lesions exists and no score of severity was proposed. The     objective of this exploratory and multicentric study is to develop and validate an endoscopic     score of severity especially dedicated to the examination by endoscopic capsule of the small     intestine. Hundred twenty patients reached of disease of Crohn corresponding to various     groups of severity will be included and will have an examination by video-capsule. The     recorded examinations will be the standardized collection of all the lesions observed by     independent readers, which will make it possible to evaluate the level of reproducibility of     the detection of each lesion. Moreover, each reader will provide his total, qualitative and     quantitative evaluations, of the severity of the attack of the small intestine. By using the     data of only one reader, a score of severity will be built by simple linear function of the     reproducible lesions observed. This score will be validated from the data corresponding to     other readers of the same examinations, and those corresponding to another sample. Lastly,     the aptitude of this score to detect the changes of the severity of the attack of the small     intestine and to define the endoscopic cicatrization will be evaluated from data obtained     among patients before and after treatment by infliximab or corticoids   "
202082|NCT00492804|"     Chronic inguinal neuralgia is one of the most important complications following inguinal     hernia repair.      It may even outweigh the benefit of the operation. Intraoperative neurectomy has been     investigated to reduce the incidence of chronic pain.      This study evaluates the effects of elective division of the ilioinguinal, iliohypogastric     and genital branch of the genitofemoral nerves on pain and postoperative sensory symptoms     after Lichtenstein hernia repair.   "
202083|NCT00492817|"     The goal of this clinical research study is to find out if stereotactic body radiotherapy to     the spine using computerized tomography (CT)-on-Rails is safe and effective in the treatment     of metastatic spine tumors.      Objectives:        -  Establish the safety and efficacy of using stereotactic body radiotherapy (SBRT) to          treat spine and para-spinal tumors in a single session.        -  Document frequency and severity of pain, symptoms and symptom interference, as well as          quality of life before and after treatment.        -  Document changes in neurological function at defined intervals compared to pre-treatment          neurological function.   "
202084|NCT00492830|"     This study is being performed to evaluate the safety and tolerability of the TRC093 antibody.   "
202085|NCT00492843|"     The objective of this trial is to assess the efficacy and safety of loading doses versus     standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone     metastatic disease.   "
202086|NCT00492856|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as gemtuzumab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Sometimes the cancer may not need more treatment until it     progresses. In this case, observation may be sufficient. It is not yet known whether     combination chemotherapy is more effective than observation when given as maintenance therapy     in treating acute promyelocytic leukemia.      PURPOSE: This randomized phase III trial is studying tretinoin, mercaptopurine, and     methotrexate to see how well they work when given as maintenance therapy compared with     observation after combination chemotherapy in treating patients with acute promyelocytic     leukemia. (Randomization and observation group closed as of 8/15/10)   "
202087|NCT00492869|"     Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and     steroids in preventing acute rejection after kidney transplantation.   "
202088|NCT00492882|"     We previously hypothesized that the excess of Anti-Mullerian Hormone (AMH) at the level of     ovarian selectable follicles could be involved in the follicular arrest of Polycystic Ovary     Syndrome (PCOS), mainly through inhibition of FSH effect on aromatase expression.In this     study, we plan to investigate whether a drop in the serum AMH level would be concomitant to     the appearance of a dominant follicle induced by administration of mild amounts of exogenous     FSH in women with PCOS.   "
202089|NCT00492895|"     Photosensitivity of the skin to UVA and UVB will be determined   "
202090|NCT00492908|"     A Randomized Comparison of a Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath)     With a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) for Percutaneous Coronary     Intervention   "
202091|NCT00492921|"     RATIONALE: High-dose cyclophosphamide may be an effective treatment for acute     graft-versus-host disease that did not respond to steroid therapy.      PURPOSE: This phase II trial is studying the side effects, best dose, and how well high-dose     cyclophosphamide works in treating patients with acute graft-versus-host disease that did not     respond to steroid therapy.   "
202092|NCT00492934|"     The study investigates if, among women with a regular cycle (between 25 and 45 days), the     endometrium is better prepared for the transfer of an embryo that was cryopreserved and if     the subsequent embryo implantation rate is higher when the cycle is started with daily,     small-dose hormonal injections than in cycles without these daily injections.   "
202093|NCT00492947|"     This research study is testing a new treatment of cancer of the head and neck.      Purpose      This research study is being done to:        1. Test the safety of the experimental cancer vaccine made of dendritic cells. An          experimental vaccine is one that is not approved by the Food and Drug Administration          (FDA).        2. To learn what effects (good and bad) the vaccine will have on you and your head and neck          cancer.        3. To learn if the vaccine will stimulate your body's white blood cells, which are part of          your immune system (your body's natural defense system).   "
202094|NCT00492960|"     This study will look at 3 doses of AT1001 for efficacy and safety for the treatment of celiac     disease.      The primary efficacy outcome is to evaluate the efficacy of multiple dose levels of AT-1001     in preventing intestinal permeability changes induced by a 6- week gluten challenge.   "
202112|NCT00486525|"     RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer     survivors.      PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving     physical activity, inflammation, fatigue, and distress in female breast cancer survivors.   "
202097|NCT00492999|"     RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances     directly into the liver. Drugs used in chemotherapy work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     floxuridine and dexamethasone directly into the arteries around the tumor together with     combination chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine     and dexamethasone works when given together with combination chemotherapy in treating     patients with colorectal cancer that has spread to the liver.   "
202098|NCT00493012|"     The purpose of the study is to investigate in overweight patients who are on a telemedically     guided weight loss program the influence of a daily vitamin D supplement on        -  weight loss and body composition,        -  selected inflammation markers and biochemical parameters of lipid and glucose metabolism          .        -  selected clinical parameters such as blood pressure, heart rate   "
202099|NCT00493025|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these     treatments before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed. Giving gefitinib after surgery may kill any tumor cells that remain     after surgery.      PURPOSE: This phase II trial is studying how well giving paclitaxel, cisplatin, gefitinib,     and radiation therapy followed by surgery and gefitinib works in treating patients with     locally advanced cancer of the esophagus or gastroesophageal junction that can be removed by     surgery.   "
202100|NCT00493038|"     This is a clinical study organized to collect clinical data to better define the activity of     some antimicrobials already marketed in Italy and in the rest of the world for the treatment     of acute bacterial rhinosinusitis   "
202101|NCT00493051|"     This is a Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the safety     and efficacy of one or two applications of topically applied GAM501 (Ad5PDGF-B/Bovine Type I     Collagen Gel) in subjects ≥ 18 years old with non-healing diabetic foot ulcers. Approximately     210 adult subjects with Type I or Type II diabetes mellitus will be enrolled at approximately     30 investigational sites in the United States.   "
202102|NCT00493064|"     The purpose of this study is to determine whether Niacin, a B vitamin, may act as a     vasodilator to encourage earlier formation of collateral blood vessels that may serve to     bypass the obstructed vein in the eye. The topical steroid eye drops are aimed at reducing     swelling in the retina, until the collateral vessels have a chance to develop.   "
202103|NCT00493077|"     This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy     in patients who have developed neutralizing antibodies during previous interferon-beta     treatment   "
202104|NCT00481065|"     This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a     seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007     influenza season in the Southern Hemisphere.   "
202105|NCT00481078|"     This randomized phase II trial is studying carboplatin, paclitaxel, and vorinostat to see how     well they work compared with carboplatin, paclitaxel, and a placebo in treating patients with     stage III or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as     carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known     whether giving carboplatin and paclitaxel together with vorinostat is more effective than     giving carboplatin and paclitaxel together with a placebo in treating non-small cell lung     cancer   "
202106|NCT00486447|"     To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and     Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of     CAD.   "
202107|NCT00486460|"     Pancreatic cancer is an aggressive disease with an extremely poor prognosis. It is the forth     leading cause of cancer-related fatalities, with an estimated one-year and five-year survival     rate of 21% and 5%, respectively. Despite recent progress, the median survival time is 6-10     months for patients with locally advanced disease and 3-6 months for metastatic disease (1).     The anti-metabolite gemcitabine has become the standard chemotherapy for locally advanced and     metastatic pancreatic cancer, after demonstrating an improved rate of clinical benefit     response and an overall survival advantage over 5-FU (2). In addition to its clinical     effectiveness gemcitabine has a manageable toxicity profile, making it an attractive agent to     investigate in combination with newer agents. Series of phase III trials were conducted     examining the efficacy of the combination of gemcitabine and a second cytotoxic agent,     including 5-FU, cisplatin, oxaliplatin and irinotecan. These gemcitabine doublets     demonstrated no survival advantage over single-agent gemcitabine (3-6). However, the     rationale for continuing to study gemcitabine-based combinations remains compelling.      Curcumin (diferuloylmethane) is a natural compound derived from the rhizome of Curcuma Longa,     an East Indian plant, commonly called turmeric. It has been shown to possess potent     anti-inflammatory and anti-oxidative properties, for which it has a long history of dietary     use as a food additive. Curcumin has also a potent anti-proliferative effects against a     variety of cancer cell lines in vitro, which stem from its ability to modulate many     intracellular signal transduction pathways (7). Human phase I-II studies found curcumin to be     safe, and indicated no dose-limiting toxicity when taken by mouth at doses up to 10 g/day (8,     9). This data, together with the dismal therapeutic options available for pancreatic cancer     patients, suggest that curcumin warrants investigation in this setting. Investigators from MD     Anderson Cancer Center and Rambam Medical Center in Haifa, have recently initiated,     separately, a phase II study of single agent Curcumin in patients with pancreatic cancer     (10).      One of the lessons learned from cancer research in recent decades is that combination     strategies can provide dramatic improvement in a therapy’s safety and efficacy over     mono-therapeutic regiments, especially if the combined drugs differ in their mode of action.     In a recent paper that was accepted for publication we demonstrated, in vitro, the mechanism,     clinical importance and implications of a novel combinatorial therapy, of celecoxib and     curcumin, that was discovered in our lab, in inhibiting the growth of several pancreatic cell     lines. P-34 (expressing high levels of COX -2), MiaPaca (Expressing low levels of COX-2) and     Panc-1 (no expression of COX -2) cell lines were exposed to different concentrations of     celecoxib (0-40µM), curcumin (0-20µM) and their combination. In P-34 cells, curcumin     synergistically potentiated the inhibitory effect of celecoxib on cell growth. The growth     inhibition was associated with inhibition of proliferation and induction of apoptosis.      These experiments further demonstrate, for the first time, that the combination effect is     correlated with synergistic augmentation of apoptosis and involves down-regulation of COX-2     protein.      The present study evaluates gemcitabine in combination with curcumin and celecoxib for     patients with pancreatic cancer.   "
202108|NCT00486473|"     To show if one MRI contrast agent is better than another one in the diagnosis of malignant     breast lesions compared to histopathology   "
202109|NCT00486486|"     The objective of this crossover, randomized, placebo controlled, double-masked study is to     compare the short-term (12 weeks) mean 24-hour IOP control and safety of the new fixed     combination (bimatoprost/timolol, BTFC) given PM with placebo once in the morning, versus     BTFC given AM with placebo once in the evening versus bimatoprost given in the evening in     patients with exfoliative glaucoma (XFG).   "
202113|NCT00486538|"     This study is designed to determine the clinical efficacy and toxicity of ABT 869 in the     treatment of subjects with advanced renal cell carcinoma who have previously received     treatment with sunitinib.   "
202115|NCT00486564|"     There is currently no curative treatment for children with relapsed/refractory neuroblastoma,     and for these children the 5 year survival rate is <10%. As such, new therapeutic approaches     are needed to treat these children. This Phase 1 clinical trial is specifically designed to     test the safety and toxicity of nifurtimox when given in combination with cyclophosphamide     and topotecan for the treatment of relapsed and/or refractory neuroblastoma . Prior to study     opening, 3 pediatric patients with neuroblastoma have received nifurtimox in combination with     this chemotherapy regimen, and all have had significant measurable responses without undue     toxicity. These case reports, as well as our in vitro and in vivo investigations into the     biologic effect of nifurtimox on neuroblastoma cells has prompted the development of this     Phase I study. This Phase I study will involve a dose escalation trial of daily oral     nifurtimox alone for one 21 day cycle of therapy, followed by continuation of nifurtimox with     the addition of standard doses of cyclophosphamide (5 days) and topotecan (5 days) for 3     additional 21 day cycles. Our primary aim is to evaluate the safety of nifurtimox alone and     in combination with these chemotherapy agents in multiply relapsed/refractory patients. Our     secondary aim will be to evaluate the pharmacokinetics of nifurtimox as well as treatment     response.   "
202116|NCT00486577|"     The purpose of this study is to determine whether chronic electrical stimulation of the     primary auditory cortex is effective in the treatment of chronic, severe and intractable     tinnitus   "
202117|NCT00486590|"     Prolacta Bioscience has developed the first purely human fortifier, Prolact-Plus, that can     provide a source of many of the required nutrients for premature, newborn infants,     particularly protein and calories. This product is made from donor human milk from which the     skim (non-lipid portion) has been separated and then concentrated. A certain amount of the     lipid content has been added back to achieve higher caloric content within a small delivery     volume. The product is then pasteurized and filled in small quantities in order to allow for     the addition of mother's own milk (or, possibly, milk from another donor). The goal of the     preparation is to achieve an increase of approximately 4 cal/oz of mother's milk and to     provide a protein level (when mixed with average pre-term milk) of about 3.5-3.8 g/100 Kcal     of feed.      The data on Prolact-Plus will be obtained prospectively from infants who will receive human     milk fortified in this fashion. The data on standard,bovine (cow)-fortified milk will be     obtained retrospectively from medical records at the participating institutions. While this     design is not necessarily optimal in this setting, it is an efficient and quick approach to     evaluating the acute clinical effect of Prolact-Plus. It is anticipated that further studies     will be conducted that will examine longer-term accounts and possibly do this in a     controlled, randomized environment.      The goal of this study is to evaluate the short-term effect of Prolact-Plus fortified human     milk when compared with bovine-based fortification of human milk on parameters such as growth     and short-term development, infectious complications and incidence of feeding intolerance in     a cohort design. Statistically, the study will attempt to evaluate a null hypothesis of     equivalent results with respect to these parameters between the two types of fortifiers as     compared with a two-sided alternative (difference between the groups).      In addition, data will be collected on overall survival and length of stay in the NICU. These     data will be collected for descriptive purposes, although an attempt will be made to compare     the findings with those obtained from the bovine-based fortifier.   "
202118|NCT00486603|"     RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine and temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     hydroxychloroquine together with temozolomide and radiation therapy may kill more tumor     cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of     hydroxychloroquine when given together with radiation therapy and temozolomide and to see how     well they work in treating patients with newly diagnosed glioblastoma multiforme.   "
202119|NCT00486616|"     The purpose of this study is to determine whether functional electrical impedance tomography     is suitable for examination of double-lumen tube placement compared with fibreoptic     evaluation.   "
202120|NCT00486629|"     The general goal of the present study is to assess the impact of a community-based exercise     and dietary intervention in pregnant women living in urban areas during and after their     pregnancy on the reduction of the risks of both diabetes and obesity in mothers and their     offspring.      We hypothesize that a community-based lifestyle intervention program during and after     gestation may improve pregnancy outcomes in terms of reducing the risk of developing obesity     or type 2 DM in mothers and their children.   "
202121|NCT00486642|"     This randomized phase II trial is studying how well giving pazopanib with or without     bicalutamide works in treating patients with prostate cancer that did not respond to hormone     therapy. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor. Androgens can cause the growth of     prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of     androgens made by the body. Giving pazopanib hydrochloride together with bicalutamide may be     an effective treatment for prostate cancer.   "
202122|NCT00486655|"     This study proposes to evaluate the ability to reduce the size and number of laparoscopic     incisions required to perform gall bladder removal by using flexible endoscopic instruments     introduced through the mouth, into the stomach and through the stomach wall.   "
202123|NCT00486668|"     The primary purpose of this study is to determine whether breast cancer tumors respond (as     measured by pathologic complete response: the absence of microscopic evidence of invasive     tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide)     followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients     with HER2-positive breast cancer. Trastuzumab will also be given to all patients after     surgery. The study will also evaluate the toxic effects of the chemotherapy combination,     including effects on the heart, and will determine survival and progression-free survival 5     years after treatment. Also, the study will look at whether there are gene expression     profiles in the tumor tissue that can predict pathologic complete response.   "
202124|NCT00486681|"     The principal objective of this single-center 2-period study is to evaluate the glycemic     control of in-patients in 3 hospital departments (Diabetology, Cardiology and Pulmonary Care)     as the rate of capillary blood glucose measurements within a pre-define target range, and to     compare results during the period I (warning of the Accu-Check Inform glucose meter on     glucose levels not activated) and period II (warning activated).   "
202125|NCT00486694|"     The purpose of this study was to determine whether the proposed first line treatment for     falciparum malaria in this region (sulfadoxine-pyrimethamine + artesunate) would be no worse     a treatment for vivax malaria that the standard vivax treatment of chloroquine. In areas     where vivax and falciparum malaria co-exist misdiagnosis of vivax malaria as falciparum is     not unlikely; it is important to know whether adequate treatment will be received in these     cases.   "
202130|NCT00486759|"     This 2-arm study was designed to compare the efficacy and safety of bevacizumab (Avastin) in     combination with rituximab (MabThera) and CHOP (cyclophosphamide, hydroxydaunorubicin     [doxorubicin], Oncovin [vincristine], prednisone) chemotherapy (R-CHOP) versus rituximab plus     CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large     B-cell lymphoma (DLBCL). Patients were randomized to receive 8 cycles of treatment with     R-CHOP plus bevacizumab or R-CHOP plus placebo. Treatment with bevacizumab/placebo and R-CHOP     was given either on a 2-week or 3-week schedule and bevacizumab was given at a weekly average     dose of 5 mg/kg (10 mg/kg for 2-week cycles and 15 mg/kg for 3-week cycles).   "
202131|NCT00486772|"     Vascular calcification and endothelial dysfunction (ED) contribute to the development of     cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a     non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification     in CKD patients while the exact mechanism has not been clarified.      This study was designed to investigate the effect of short-term sevelamer treatment on both     serum fetuin-A concentrations and ED seen in CKD patients.   "
202153|NCT00487058|"     This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in     Japanese patients. Gimatecan is administered orally twice per week, every 28 days, to adult     patients with advanced solid tumors who have progressed despite standard therapy or for whom     standard systemic therapy dose not exist.   "
202132|NCT00486785|"     Primary Objective:        -  To assess the sexual function improvement from baseline to the end of treatment (Week 24          or premature withdrawal (PW)) with XATRAL 10mg OD.      Secondary Objective:        -  To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and          sexual disorders,        -  To compare the improvement in sexual function, urinary symptoms and Quality of Life          among the different regions,        -  To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-Item version of          the International Index of Erectile Function),        -  To assess the onset of action of XATRAL 10mg OD,        -  To assess the peak flow rate improvement (Qmax),        -  To assess the safety and the tolerability of XATRAL 10mg OD.   "
202133|NCT00486798|"     The purpose of this study is to compare the efficacy of quetiapine IR, following rapid     titration versus conventional titration in patients with acute psychosis   "
202134|NCT00486811|"     The purpose of this study is to evaluate whether tapentadol (CG5503) prolonged-release (PR)     tablets at doses of 100-250 mg twice daily provide a better pain relief in patients with     moderate to severe chronic pain due to osteoarthritis of the knee than a placebo (a     medication without active substance). In addition the tolerability of CG5503 PR will be     assessed. One third of the patients will receive CG5503 and one third will receive placebo.     For further comparison one third of the patients will receive oxycodone controlled release     (CR) at doses of 20-50 mg twice daily which is an active approved pain medication. Please     note that tapentadol ER (Extended Release) and tapentadol PR (Prolonged Release) are     identical and used interchangeably. This is due to United States of America and European     naming conventions.   "
202135|NCT00486824|"     Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor.     This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral     indomethacin for preterm labor tocolysis in an effort to identify which drug is most     effective.      Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to     receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider     will be blinded to the identity of the study drug. An abdominal ultrasound will be performed     in the labor and delivery unit prior to the administration of the tocolytic in order to     assess fetal position and fluid level, and to document fetal cardiac activity and movement,     and will be repeated at 48 hours post-randomization. Following randomization, the patient     will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each     containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either     25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6     hours for 48 hours. Tocolysis beyond 48 hours will not be used.   "
202136|NCT00486837|"     The objective of this trial is to determine the optimal region of the lung for depositing     Prolastin (alpha-1 antitrypsin; AAT) by inhalation in order to treat cystic fibrosis (CF).     The AKITA® nebulizer has settings which can be varied to target the inhaled drug to either     the deep lung or to the upper airways in a one to one randomization. The study will measure     how much of the activity of the enzyme elastase is inhibited by AAT.   "
202137|NCT00486850|"     Title of Study: A Prospective, Randomized, Multicenter Trial Comparing Synchronized     Intermittent Mandatory Ventilation (SIMV) vs. Early Extubation to Nasal Intermittent Positive     Pressure Ventilation (NIPPV) after Surfactant Treatment in Preterm Infants with Respiratory     Distress Treatment Period (Planned): 7 days Objectives: To compare the impact of early     extubation [within 120 minutes of birth to Nasal Intermittent Positive Pressure Ventilation     (NIPPV group) vs. Synchronized Intermittent Mandatory Ventilation (SIMV group) on the     incidence of mechanical ventilation via endotracheal tube at 7 days of age in 26 to 29 + 6     weeks gestation premature infants with respiratory distress treated with intratracheal     Curosurf (poractant alpha) within 60 minutes of birth.      Secondary objectives include evaluation of overall clinical outcomes at 7 days, 28 days, and     36 weeks postmenstrual age (PMA) and/or at discharge, complications, safety, and adverse     events.      Number of Subjects: 110   "
202138|NCT00486863|"     The purpose of the study is to understand whether the drug praziquantel (PZQ) is safe for the     mother and developing baby when the mother has schistosomiasis (a type of worm) infection,     and whether the drug may improve the mother's and baby's health. The usual practice is to     wait until after a mother has finished breast feeding before giving the medicine.     Approximately 375 infected pregnant women, ages 18 and over, in endemic villages in Leyte,     The Philippines will participate. Study volunteers 12-16 weeks pregnant will be given PZQ or     an inactive pill (placebo) and stay in the hospital overnight. Small blood samples will be     collected before and after the medication is taken. Three stool and urine samples will be     taken during a total of 7 study visits. An ultrasound image (picture or outline of the unborn     baby) will be performed. When the baby is born, a small blood sample will be taken. Mother     and baby will be followed for up to 8 months before the baby is born and 1 month after.   "
202139|NCT00486876|"     The primary objectives of this study are to evaluate the clinical safety and tolerability and     to assess the efficacy of 100 mg, 200 mg, and 300 mg BID dextofisopam compared with placebo     in female outpatients with diarrhea-predominant or alternating irritable bowel syndrome     (IBS).   "
202140|NCT00486889|"     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the     body's cells to break down glycogen (a stored form of sugar) within specialized structures     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates     and is stored in various tissues, especially heart and skeletal muscle, which prevents their     normal function. The overall objective of this study is to evaluate the long-term growth and     development of patients with infantile-onset Pompe disease with alglucosidase alfa before 1     year of age. Patients will be followed for 10-year period.   "
202151|NCT00487032|"     The investigators wish to evaluate the onset of tolerance to nasal decongestants like     oxymetazoline (available over the counter) and the mechanism of tolerance particularly with     differential effects on alpha 1 and alpha 2 adrenoreceptors on the nose. The investigators     will 'tease' out by using an alpha 1 blocker called Prazosin. The investigators hypothesize     that alpha 1 receptors mediate arterial constriction and this will be captured by measuring     nasal blood flow. The investigators also hypothesize that alpha 2 receptors mediate venous     sinusoid constriction and this the investigators will capture by airflow parameters like Peak     Nasal Inspiratory Flow, Rhinomanometry, Oscillometric indices etc.   "
202141|NCT00486902|"     Pain control after cesarean delivery is associated with improved breastfeeding and infant     rooming-in times. In addition, inadequate analgesia leads to elevated plasma catecholamine     concentrations, which negatively affect every organ system. There is growing evidence that     ketamine, N-methyl-D-aspartate receptor antagonist, is efficacious when used as an adjuvant     in postoperative pain control. A 2006 Cochrane Collaboration systemic review and     meta-analysis concluded, Ketamine in subanesthetic doses….is effective in reducing morphine     requirements in the first 24 hours after surgery.      Ketamine's prolonged analgesic effect, despite its short half-life and its use in low doses,     is theorized to be due to blockade of spinal cord central sensitization. Central     sensitization is a phenomenon whereby repeated painful stimulus leads to more severe pain     perception over time despite no change in the intensity of the painful stimulus.Ketamine may     also prevent the development of acute opioid tolerance. Ketamine's analgesic effects have     also demonstrated in the obstetric population. Post-cesarean delivery morphine requirements     in women who received ketamine as part of a general anesthesia technique were decreased.     Similary, low-dose ketamine in conjunction with bupivacaine-only spinal anesthesia reduced     postoperative analgesic requirements compared to bupivacaine-only spinal anesthesia and     bupivacaine-fentanyl spinal anesthesia.      In the United States, healthy women scheduled for elective cesarean delivery commonly receive     spinal anesthesia with bupivacaine-fentanyl-morphine. To our knowledge, IV ketamine has not     been studied as an adjuvant to this regimen in the analgesic management in post-cesarean     delivery patients. Multimodal therapy for postoperative pain control is widely practiced due     to the advantage it provides in blocking multiple pain pathways while minimizing side effects     of each individual pain medication. We hypothesize that low dose intravenous ketamine will     improve multi-modal post-cesarean analgesia compared to placebo. The purpose of this study is     to evaluate this hypothesis and study the possible side effects of this regimen in     combination with bupivacaine-fentanyl-morphine spinal anesthesia.   "
202142|NCT00486915|"     Stroke is a major cause of morbidity in western society, and an infrequent complication of     cardiac surgery. The majority of thromboembolic strokes arise from the left atrium, in     particular the left atrial appendage. This study aims to assess the short-term effects of     left atrial appendage ligation in terms of postoperative clinical and biochemical parameters;     and the long-term effects of left atrial appendage ligation in terms of stroke incidence.   "
202143|NCT00486928|"     Background-:. The Medtronic-Hall (MH) valve was developed and for the first time implanted in     Oslo in 1977. A total of 1,104 patients received this valve at     Rikshospitalet-Radiumhospitalet HF in the period 1977-87. In the present study we followed     all 816 patients undergoing aortic valve replacement (AVR) over a 25-year period.   "
202144|NCT00486941|"     The purpose of this study is to determine whether a short group intervention programe aiming     at lifestyle changes at a local health centre can improve risk factors for cardiovascular     disease   "
202145|NCT00486954|"     EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the     optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is     designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel     compared to patients receiving only paclitaxel.   "
202146|NCT00486967|"     Whether insulin resistance common among Chronic Heart Failure (CHF) patients in Tayside and     identify factors associated with insulin resistance in CHF.      We also want to identify mechanism for the impaired exercise capacity and reduced peak VO2 in     CHF   "
202147|NCT00486980|"     This is a multinational, randomized, double-blind study comparing the efficacy and safety of     two single dose regimens of peramivir administered intramuscularly versus placebo in adults     with uncomplicated acute influenza.   "
202148|NCT00486993|"     According to WHO estimations, cardiovascular diseases (CVDs) are the number one cause of     death globally. More people die annually from CVDs than from any other cause. An estimated     17.5 million people died from CVDs in 2005, representing 30% of all global deaths. Of these     deaths, an estimated 7.6 million were due to coronary heart disease and 5.7 million were due     to stroke.      Over 80% of CVD deaths take place in low- and middle-income countries and occur almost     equally in men and women. In Paraguay, prevalence of classic risk factors, as well as new     ones, like the metabolic syndrome are not completely known.      Government health policies in industrialized countries are focusing on programs to modify     cardiovascular risk factors. In developing countries, prevention of coronary heart disease     and stroke through modification of cardiovascular risk factors are not playing a large role     at the moment.      The aim of this study is to define the effects of changes in lifestyle on cardiovascular risk     factors, when added to optimized standard pharmacological therapy for arterial hypertension,     diabetes mellitus and hyperlipidemia, in an ambulatory urban patient population.   "
202149|NCT00487006|"     BACKGROUND AND PURPOSE      Critical illness hyperglycemia (CIH) - elevated blood glucose in the critically ill patient     population - has gained much interest among health care providers over the past several     years. Clinical studies in adults have documented a high rate of hyperglycemia in some     post-surgical and medical intensive care units (ICUs). However, the primary reasons for     interest in this topic are not due just to its high rate, but also to the fact that by     returning the high glucose levels found in this population to normal with insulin therapy can     dramatically improve clinical outcomes by decreasing both morbidity and long-term mortality.     Because of this, aggressive glucose control has become common practice in adult ICU critical     care management.      Although there is substantial data describing the high incidence of CIH in adult patients,     there is little information regarding this condition in children. A single retrospective     study recently published also suggested a high incidence of CIH in children with critical     illness secondary to both medical and surgical causes. It is yet to be determined if, like in     adults, normalizing blood glucose levels with insulin improves outcomes in this pediatric     population. Because evidence appears compelling that hyperglycemia is both common and     detrimental in adults, many pediatric ICUs have likewise begun to focus on aggressively     treating hyperglycemia in critically ill children.      The proposed study is a prospective observational pilot study to occur in the Pediatric     Intensive Care Unit (PICU) at Children's Healthcare of Atlanta at Egleston. This prospective     pilot study is being done to evaluate the endocrine factors associated with, if not     responsible for, CIH, and the changes that take place with the restoration of normal blood     glucose levels by insulin therapy.      To address these profound issues this study will pursue two interrelated Aims:      Aim #1: To determine if critical illness hyperglycemia is associated with absolute insulin     deficiency, peripheral insulin resistance, or both.      Aim #2: To characterize the requirement of insulin required to initially restore and maintain     normal blood glucose levels, and compare the changes in insulin that take place with this     normalization in patients with CIH.      We hypothesize that the hyperglycemic response to critical illness will be associated with     abnormally low levels of insulin as compared to patients without critical illness     hyperglycemia.   "
202225|NCT00495118|"     The purpose of this study is to document the long-term safety of 25, 37.5, or 50 mg     long-acting injectable risperidone given via injection to the gluteal muscle every 2 weeks to     subjects with schizophrenia or schizoaffective disorder.   "
202150|NCT00487019|"     A prospective two-center antibiotic regimen switch study will be conducted to compare the     clinical efficacy of two antibiotic regimens - penicillin/gentamicin versus     ampicillin/gentamicin - in the empirical treatment of early onset neonatal sepsis. The     influence of either regimen on bowel colonization pattern and on the development of     antibiotic resistance of gut microflora will also be assessed. The primary endpoint is the     need for a change in antibacterial treatment within 72 hours of therapy, based on pre-defined     criteria. Secondary endpoints will be the incidence rate and etiology of early and late onset     neonatal sepsis and susceptibility pattern of causative microorganisms; mortality rate within     60 days; duration of hospitalization in NICU; duration of artificial ventilation;     colonization pattern and susceptibility of colonizing bacteria (including resistance to     empiric antibiotic regimen).   "
202155|NCT00493090|"     This study will address the key question of developing shared understanding and negotiating     mutually acceptable outcomes between people with asthma and healthcare professionals by     applying theoretical knowledge of self regulation and communication skills learning and     practice to asthma consultations. This study will facilitate integration of best practice     into normal care using the BTS/SIGN asthma guidelines as the basis for structured care. This     intervention has been show to be effective in the US. We aim to show that it can be effective     in the UK setting in a cluster randomised control trial. We aim to modify and evaluate the     intervention in such a way that it can be easily offered across UK primary care settings,     with the possibility of significant benefits for patients. The intervention is based on the     principle of empowering patients to manage their condition themselves, is consistent with the     aims of Asthma UK, and, for this reason, we believe that Asthma UK may wish to be associated     with this project.   "
202156|NCT00493103|"     The aim of this study was to identify mutations in the thyroglobulin gene that might be     present in patients with fetal goiter and congenital goiter hypothyroidism.   "
202157|NCT00493116|"     This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a     washout period in patients with Multiple Sclerosis who have previously developed neutralizing     antibodies to Interferon-Beta   "
202158|NCT00493129|"     Primary Objective:      1. To assess the response rate of ONTAK in Systemic Mastocytosis (SM) patients.      Secondary Objectives:        1. To assess the safety of ONTAK in SM patients.        2. To evaluate the time to progression and duration of response following treatment with          ONTAK.   "
202159|NCT00493142|"     The purpose of this study is to determine whether a pre-operative home rehabilitation     exercise program designed for knee replacements is more effective than pre-operative usual     care.   "
202160|NCT00493155|"     This study will determine the maximum tolerated dose, and assess the safety, tolerability and     pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid     tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be     escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and     tolerability of the previous dose, until the maximum tolerated dose is reached. The     anticipated time on study treatment is until disease progression, and the target sample size     is <100 individuals.   "
202161|NCT00493168|"     The first aim of this study is to determine how often unrecognized myocardial infarction     occur in patients using a magnetic resonance imaging (MRI) technique (known as delayed     enhancement MRI), as compared to the electrocardiogram. The second aim of this study is to     determine the severity of coronary heart disease of the patients with unrecognized myocardial     infarction. The final aim is to determine how the presence of unrecognized myocardial     infarction detected by the MRI affects lifespan.   "
202162|NCT00493181|"     The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the     platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet     counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine     kinase inhibitors such as AMN107, dasatinib, or SK1606.      Primary Objective:      1. To determine efficacy of low-dose interleukin-11, (IL-11, oprelvekin, NeumegaTM) in     improving the thrombocytopenia associate with imatinib or other tyrosine kinase inhibitor     therapy in patients with CML.      Secondary Objective:      1. To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia     associated with imatinib or other tyrosine kinase inhibitors   "
202163|NCT00493194|"     This prospective, randomized study, comparing sirolimus to cyclosporine in renal transplant     recipients, has two major objectives:        1. -To determine the incidence and the degree of interstitialfibrosis and arteriosclerosis,          as wel as the glomerular volume in protocol biopsies at 6 months in sirolimus-and in          cyclosporine-treated renal allograft recipients, by means of quantitative computerized          image analysis.             -  To determine the prognostic implication of these morphologic changes.        2. To study the expression of genes, involved in inflammation and fibrosis, in protocol          biopsies at 6 months in sirolimus-and cyclosporine-treated renal allograft recipients.   "
202164|NCT00493220|"     The objectives of this study are:        -  to establish the safety of subcutaneous administration of ceftriaxone at different          concentrations, with and without HYLENEX recombinant, and to determine the maximum          tolerated concentration;        -  and to establish the pharmacokinetic comparability of subcutaneous administration of          ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX          recombinant and to IV administration.   "
202165|NCT00493233|"     The literature suggests that when a patient is prescribed more than one antipsychotic for at     least 30 days, he or she is likely to continue on that combination. In this 12 week study 100     adult patients being treated on more than one antipsychotic medication for at least 30 days     will be recruited. In order to control for the natural course of the illness, patients will     be randomly assigned to one of two groups: the first group will continue the second     medication hidden in a capsule at the same dose, while the second group will be given an     inactive capsule (placebo) - the capsules in both group will be identical such that neither     the patient nor the treating doctor will be able to identify the group assignment.   "
202166|NCT00493246|"     We are doing this study to find out what happens to acetaminophen in the body after it is     given to children through the vein. Children's bodies may handle drugs differently than     adults. Understanding how long the drug stays in the body and how the drug is changed or     metabolized by the body (called pharmacokinetics) is an important step in learning what the     best dose of acetaminophen for children should be. We are also interested in learning about     the safety of this medication when given to children.   "
202167|NCT00493259|"     The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for     quality of life and altered health related issues.   "
202168|NCT00493272|"     The purpose of the present study is to perform a comprehensive description of haemostasis     parameters before and after haemodilution with Hydroxyethyl starch (HES) following acute     bleeding during elective surgery. Moreover the study aims to test the in vivo haemostatic     potential of fibrinogen concentrate in dilutional coagulopathy caused by HES in a clinical,     prospective, placebo-controlled randomised setup.      We hypothesise; a) A coagulopathy is induced following in vivo haemodilution; b) the     coagulopathy is improved or partially improved by fibrinogen.   "
202170|NCT00493298|"     The primary objective of this study is to assess the long-term safety and impact on disease     activity and progression of natalizumab in participants with relapsing remitting multiple     sclerosis (RRMS) in a clinical practice setting.   "
202171|NCT00493311|"     A research study to determine if acetaminophen (APAP) given intravenously (IV-a liquid given     through a needle into a vein in your arm) is safe and effective in controlling fever when     compared to placebo. Acetaminophen given this way is the investigational part of this study.   "
202172|NCT00493324|"     A vaccine causes the immune system to produce antibodies (immune response) to specific germs     to protect the patient. This study evaluates the immune response to the pneumococcal vaccine     in adults with Alefacept-treated chronic plaque psoriasis.   "
202173|NCT00493337|"     The objective of the study is to test the effectiveness of a community pharmacist-led     intervention to increase adherence to lipid lowering treatment.   "
202174|NCT00493350|"     Primary Objectives:        1. To validate the prognostic significance of circulating tumor cells (CTCs) in patients          with newly diagnosed metastatic breast cancer (MBC).        2. To prospectively determine if assessment of CTCs can be used to stratify patients with          MBC into two prognostic groups independent of existing methods i.e. hormone-receptor          status, site of metastasis (e.g. visceral vs. non visceral) and treatment administered          (e.g. chemotherapy vs. hormonal therapy).        3. To incorporate this information into the current TNM staging system by sub-classifying          stage IV disease into two prognostic groups, Stage IVA and Stage IVB.      Secondary Objective:      1. To perform global gene profiling on selected specimens and correlate the profiles with     clinical outcomes.   "
202175|NCT00493363|"     There are worrying signs that parasitological responses to the artemisinin drugs for     uncomplicated falciparum malaria are slower than elsewhere in the world.If responses to     artesunate are poor it is essential to have characterised the blood concentration profile as     well as the parasitological response to differentiate resistance from abnormal     pharmacokinetics.      The primary objective of the study is to assess the level of resistance to artemisinin     derivatives in Western Cambodia.      A detailed evaluation of 2 different artesunate containing regimens in patients with     uncomplicated malaria will be performed. Patients will be randomised to receive either a)     Artesunate 2mg/kg/day for 7 days or b) Artesunate 4mg/kg/day for 3 days plus mefloquine     15mg/kg on day 3 and 10mg/kg on day 4 The effect on parasite clearance and cure will be     assessed in relation to blood concentrations of the antimalarial drugs ('PK-PD').   "
202176|NCT00493376|"     The purpose of this study is as follows:        -  to determine whether tirapazamine damages cervical tumour DNA immediately after its          administration        -  to determine the blood flow and oxygen level of cervical tumour before and after          treatment with tirapazamine   "
202177|NCT00493389|"     Cortisol deficiency is diagnosed by the adrenocorticotrophin (ACTH) stimulation test. This     test measures cortisol levels in the blood before and after giving an injection of ACTH.     Currently, the results of this test can only be reliably interpreted when it is carried out     on people in non-stressful situations. Frequently the test is carried out in hospitalized     patients in stressful situations, giving results that are hard to interpret.      Our study is to first do this test in a non-stressful situation, followed by a repeat test in     a stressful situation, to compare the results and create a set of guidelines for interpreting     the test when it is carried out in stressful situations.   "
202178|NCT00493402|"     The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes     (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with     hepatocellular carcinoma (HCC).   "
202296|NCT00496093|"     To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy     adults in India.   "
202179|NCT00493415|"     The purpose of this study is to evaluate the effect of nitro-glycerine on the     microcirculation (smallest vessel type) in patients with severe sepsis and septic shock.      Nitro-glycerine is a well known medicine in cardiology and is used to improve circulation. In     this ICU the investigators use nitro-glycerine to improve the organ perfusion; but it's no     common therapy in the rest of the world. The investigators now compare nitro-glycerine and     placebo by looking to the sublingual microcirculation by a small camera (SDF imaging).   "
202180|NCT00493428|"     Recent studies indicate that liver cancer cells possess a receptor called the GABA-B receptor     that when activated, inhibits the spread of cancer cells in test tubes. One of the drugs that     activate these receptors is Baclofen, an agent that was originally developed to treat     patients with various neurologic disorders. In this study, patients with recently identified     liver cancer will be treated with Baclofen in an attempt to prevent or delay spread of the     cancer beyond the liver. The time it takes for liver cancer to spread in the patients will be     compared to the results obtained from patients enrolled in previous studies where Baclofen     was not used.   "
202181|NCT00494533|"     Multi-center, double-blind, placebo-controlled, randomized, parallel study comparing     continuous intravenous (IV) Remodulin® to placebo in patients with pulmonary arterial     hypertension either primary (PPH) or associated with human immunodeficiency virus (HIV)     infection or collagen vascular disease).   "
202182|NCT00494546|"     Objective: The objective of this study is test the hypothesis that delivering a higher     percentage of the radiation dose as external radiation versus implant will lead to higher     tumor control rates.      Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma     (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy     versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy,     respectively).   "
202189|NCT00494637|"     Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the     risk of contrast induced nephropathy with coronary angiography. The investigators plan to     randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary     angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate     beginning one hour before the procedure and for four hours after. The primary endpoint is the     development of contrast nephropathy within 48-72 hours after the procedure. Patients with an     ejection fraction <30%, overt CHF, hypokalemia and alkalemia will be excluded.   "
202190|NCT00494650|"     This study will evaluate the effectiveness of tailored cognitive behavioral therapy in     treating post-traumatic stress disorder in people with additional mental illnesses.   "
202183|NCT00494559|"     People with diabetes mellitus are more prone to coronary heart disease, stroke, and     peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk     factor for the progression of coronary artery disease. Several studies have been reported     that diabetes increased the risk of cardiovascular mortality in both men and women. With the     introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later     months have reduced dramatically in several studies. However, even with DESs, diabetic     patients showed increased rates of restenosis and late loss index compared with nondiabetic     patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous     coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes     after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been     demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era     of DESs, no study has demonstrated the clinical and angiographic outcomes in diabetic     patients after zotarolimus-eluting stent implantation by using intravascular ultrasound     (IVUS).      Pioglitazone is used in the treatment of diabetic patients. Thiazolidinediones increase     insulin sensitivity and show favorable effect on blood glucose levels and lipid profiles. The     effect of pioglitazone on neointima volume and inflammatory markers has not been compared in     prospective manner after zotarolimus-eluting stent implantation. The purpose of this     prospective, randomized, single blinded trial is to compare the effect of pioglitazone on     inflammatory markers and neointima volume by using IVUS in diabetic patients.   "
202184|NCT00494572|"     The purpose of this study is to determine if montelukast, in addition to standard treatment     is helpful in treating patients ages 6-18 who are in the hospital because of status     asthmaticus.   "
202185|NCT00494585|"     The goal of this clinical research study is to find out if CEP-701 can help control     myelofibrosis (MF). The safety of CEP-701 will also be studied.   "
202186|NCT00494598|"     There is a need to understand how long anesthetic drugs last in the brain during surgery on     the ascending aorta or aortic arch. Drugs can have a prolonged effect when blood temperature     is made cold therefore the influence of temperature needs to be studied. This type of surgery     allows us to answer questions about how anesthetic drugs behave when they are given during a     routine portion of surgery. Patients will be provided with anesthetic drugs during surgery     while on a heart lung machine. After the drug is injected into the heart lung machine it will     be delivered to the brain to provide more sleep and pain relief. Immediately after the     injection of anesthetic drugs, blood samples will be taken from an existing intravenous line     in the neck and plasma drug concentrations measured. This will help us to understand how long     drugs last in the brain during this type of surgery.   "
202187|NCT00494611|"     There are more than 140,000 new cases of colon cancer diagnosed each year, and over 60,000     Americans die from colon cancer annually. To date, surgical resection remains the mainstay of     treatment for colon cancer. However, between 35% and 45% of patients, despite colon surgery,     retain unseen tumor cells in the bloodstream or in small clumps in the liver or other     tissues. It is for this reason that postoperative chemotherapy (anti-tumor drugs) is     recommended and given to some patients after surgery. Conventional chemotherapy is usually     started no earlier than 4 to 6 weeks after the colon cancer has been resected.      Despite surgery and conventional chemotherapy, a significant number of patients develop     cancer recurrences and many go on to die from the cancer. For this reason, investigators     continue to look for new cancer treatments and approaches. The study under consideration     proposes to give colon cancer patients an anti-cancer therapy for 3 weeks before and for 3     weeks after undergoing operation to remove the colon cancer. This time period is referred to     as the perioperative period. Presently, around the world, doctors do not administer any     type of anti-cancer therapy during the perioperative period. It is the belief of the     investigators carrying out this study that this period may be an ideal time to fight the     tumor and that treatment given during this time may improve survival and reduce cancer     recurrence rates. Patients who choose to receive this biologic anti-cancer treatment     immediately before and after surgery can also receive conventional chemotherapy at the usual     time (4-6 weeks after surgery). Thus, this perioperative anti-cancer treatment would not     interfere with the standard chemotherapy regimens used today.      The drug that is to be given in this study is called Cetuximab (also known as Erbitux).     This is an anti-cancer drug which has already been approved by the FDA for use in patients     who have colon cancer. This drug, like all of the other anti-cancer drugs used for treating     colon cancer, has been given either well after surgery or to patients with very advanced     disease who have not undergo surgery. What is unique about the St. Luke's Roosevelt study is     that the drug will be given during the 3 weeks before surgery and for the first 3 weeks after     the colon resection surgery.      To summarize, Cetuximab is a humanized antibody to EGFR which has been shown to be effective     in killing tumor cells in patients with colon cancer.      In this study the Cetuximab is to be given 1) after the surgery, 2) immediately before the     operation, or 3) both before and after surgery. Entry into the study means that the operation     may be delayed for at least 3 weeks in order for the drug to be given. Since many patients     who do not participate in any research studies wait at least that long for surgery this does     not constitute a delay. The drug has a safety profile and has been well tolerated, in     general. However, since thus far it has not been given in the weeks immediately prior to or     immediately after major surgery there is no safety profile for this drug during the     perioperative period. The primary goals of this preliminary study are to establish the safety     of Cetuximab in the perioperative period and to demonstrate that the preoperative doses have     an actual impact on the tumor cells themselves.   "
202315|NCT00496340|"     The objective of this trial is to determine whether a regimen of pentostatin and busulfan     (IV) can facilitate engraftment of human leukocyte antigen (HLA) partially compatible     siblings and unrelated donor transplants by using CD4+ laboratory-guided immunosuppression     among 41 transplant patients meeting the inclusion criteria.   "
202188|NCT00494624|"     We can not predict which wheezing child younger than 3 years of age benefits from systemic     glucocorticoid and which one does not. It is not known whether the differences in the     efficacy are related to the differences in viral etiology, atopy, immunogical maturity or age     of the patient. The study aims to answer the following questions: 1. What is the viral     etiology of acute childhood expiratory wheezing? 2. What is the efficacy of prednisolone in     relation to age, atopy and viral etiology in acute childhood wheezing? 3. Does prednisolone     treatment increase risk for secundary bacterial infection in acute childhood expiratory     wheezing? 4. What is the significance of inflammatory markers in predicting the efficacy of     systemic steroid or patient outcome in acute childhood expiratory wheezing? Study will follow     randomized, double blind, placebo-controlled parallel design. Study will start in Septemper     2000 and will be performed at the Department of Pediatrics, Turku University Hospital, Turku     Finland. The study population will be 300 hospitalized wheezing children aged 3 months – 15     years. Investigational drug will be prednisolone, first dose 2 mg/kg, then 2 mg/kg/d/3 (max.     60 mg/vrk) p.o. for 3 d and comparative drug will be placebo tablet similar to     investigational drug with the equal dosage. The primary outcome will be the time until ready     for discharge. The study will provide new and important information for the diagnostics,     treatment, disease outcome and prevention of acute childhood expiratory wheezing.   "
202201|NCT00494793|"     The purpose of this multicenter trial is to prospectively evaluate a novel combination of     vacuum assisted wound closure (VAWC) and mesh mediated fascial traction for closure of open     abdomens.   "
202217|NCT00495014|"     This study represents the second Phase 1 study with GSK376501 and the goal is to further     evaluate its safety and tolerability. The way the human body processes GSK376501 will also be     determined.   "
202191|NCT00494663|"     DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the     ketoconazole molecule for the treatment of elevated blood glucose associated with type 2     diabetes mellitus. Ketoconazole (Nizoral®) is a drug available by prescription for the     treatment of fungal infections however DIO-902 is an investigational drug. DIO-902 may lower     blood glucose by lowering levels of a naturally occurring hormone called cortisol. Elevated     cortisol may contribute to the development of type 2 diabetes.      The purpose of this research study is to test the safety of DIO-902 when taken by mouth with     metformin and the cholesterol-lowering drug atorvastatin to determine the type and severity     of any side effects from this treatment.      Other purposes of the study are to see how the treatment affects your blood glucose levels,     cholesterol levels, blood pressure, and waist circumference.   "
202192|NCT00494676|"     The purpose of this study is to evaluate the functional utility for general mobility     (walking) of new high power permanent peripheral prism glasses, which provide visual field     expansion device for patients with homonymous hemianopia (the complete loss of half the field     of vision on the same side in both eyes). The efficacy of real peripheral prism glasses will     be assessed relative to sham peripheral prism glasses.   "
202193|NCT00494689|"     The investigator(neurologist) has published a study in International Congress Series, in the     15th International Conference of Biomagnetism Vancouver Proceedings 2006,and Science Direct     website, of 15 patients with brain ischemia and dilated ventricles who improve when treated     with transcranial monitoring or low ultrasound wave intensity (milliwatts) and with rapid     magnetic stimulation which is also a diagnostic tool routinely used by many     neurophysiologists. Before, these patients will progress and may need a brain shunt called     Ventriculo-peritoneal shunt. He and collaborators now would like to do a double study as this     appears to be a cheap and effective alternative treatment and help patients to walk again.   "
202194|NCT00494702|"     The investigators hypothesize that using low oxygen concentrations during resuscitation of     extremely premature infants will avoid oxidative stress derived damage and improve outcome.   "
202195|NCT00494715|"     Nephropathy of type 2 diabetes is the leading cause of end stage renal disease (ESRD)     world-wide and is associated with a dramatic excess cardiovascular morbidity and mortality.     Two randomized trials found that angiotensin II receptor blockers (ARBs) reduce the incidence     of ESRD by about 30%, but have no appreciable effects on cardiovascular mortality. Available     data suggest that ACE inhibitors might be similarly renoprotective and even more     cardioprotective, but large scale trials on ACE inhibitors, alone or combined with ARBs, in     overt nephropathy of type 2 diabetes are missing.      This study will compare the effects, at comparable blood pressure control (systolic/diastolic     <130/80 mmHg), of dual renin-angiotensin-system (RAS) blockade by half dose of benazepril and     valsartan combination therapy as compared to single RAS blockade by benazepril or valsartan     alone at full dose, 20 mg and 160 mg respectively, on ESRD and cardiovascular events in     high-risk patients with type 2 diabetes and overt nephropathy, defined as serum creatinine     >1.8 mg/dl and < 3.2 mg/dl and spot morning urine albumin to creatinine ratio >1000mg/g for     the patients without previous ACE inhibitor and ARB therapy and >500mg/g for the patients     with previous ACE inhibitor or ARB therapy and no specific contraindications to the study     drugs. The relationships between renal and cardiovascular outcomes will also be evaluated.      102 patients will be treated for at least 3 years. At comparable blood pressure control, the     study is expected to show a more effective reduction in ESRD and cardiovascular events with     combined than with single drug ACE inhibitor or ARB therapy. As compared to ARB, ACE     inhibitor therapy is expected to have a similar effect on ESRD, but a superior     cardioprotective effect. Applied to clinical practice, the findings should help reducing     renal and cardiovascular complications, and related treatment costs, of type 2 diabetes.   "
202196|NCT00494728|"     Objectives:      Primary Aim:      To conduct a preliminary randomized trial in smokers with current recurrent major depressive     disorder (MDD), current MDD with a single episode of 2 years or more, and current dysthymia     comparing combined cognitive behavioral analysis system of psychotherapy (CBASP) and standard     smoking cessation treatment (ST) (CBASP/ST) to combined Health Education and ST treatment     (HE/ST) to:      1. Examine the effects of CBASP/ST on both short and long-term point prevalence abstinence      Secondary Aims:        1. To test the hypothesis that depressed smokers in the CBASP/ST treatment will experience          greater decreases in depressive symptoms from baseline to each of our follow-up          assessment points, compared to depressed smokers in the HE/ST treatment, and;        2. That depressed smokers in the CBASP/ST treatment will experience greater improvements in          psychosocial functioning from baseline to follow-up assessment points, compared to          depressed smokers in the ST treatment.        3. To evaluate between subject neurophysiological predictors of abstinence at 3 and 6          months, and:        4. To evaluate within-subject changes in neurophysiological responses to emotional and          smoking-related stimuli across treatment sessions, and the relation of these changes to          abstinence and depressive symptoms at end of treatment, and 3- and 6-months.   "
202197|NCT00494741|"     The Mycophenolate Steroid Sparing (MYSS) study demonstrated that, in the setting of a     maintenance immunosuppressive regimen without steroids, mycophenolate mofetil (MMF) and     azathioprine (AZA) provided the same efficacy in preventing acute rejection episodes and     allograft dysfunction in kidney transplant recipients. Induction therapy with basiliximab     combined with low-dose thymoglobulin (RATG), through a transient depletion/inhibition of T     lymphocytes, allows further reducing the need for maintenance immunosuppression.      Aim of the present study is to assess whether under this induction strategy MMF and AZA are     equally effective in preventing acute rejection and chronic allograft nephropathy (CAN), even     after cyclosporine (CsA) withdrawal.      Two-hundred-twenty-four kidney transplant recipients from deceased donors given induction     therapy with two 20 mg basiliximab injections 4 days apart and a seven-day course of RATG     (0.5 mg/kg/day), will be randomly allocated on a 1:1 basis to 3-year treatment with low-dose     MMF or AZA, added-on CsA maintenance therapy. At 1 year, rejection-free patients with no     evidence of tubulitis at kidney biopsy will withdraw CsA and will have a kidney biopsy 3 year     post-transplant for evaluating the presence and severity of CAN. Should the cumulative     incidence of acute rejection exceed 15% during CsA withdrawal the study will be stopped.     Should the incidence differ by >30% between the two treatment arms, all patients will be     given the most effective treatment and the follow up will be continued. A final biopsy will     be repeated 4 years post-transplant.      Most patients are expected to be effectively maintained on single drug immunosuppression,     which implies less steroid- and CsA- related complications and treatment costs. MMF is     expected to prevent CAN more effectively than AZA. However, should AZA be more or as     effective compared to MMF, at study end all patients could be shifted to AZA, that is 15-fold     less expensive than MMF. Extended to clinical practice, these findings should translate in     improved patient care and major cost-savings for the Health Care System.   "
202198|NCT00494754|"     The purpose of this study is to prepare instruments for Autism Spectrum Disorder (ASD), to     collect clinical, neuropsychological, and genetic data of ASD probands and their family, and     to identify the genetic variants close to etiological genes of ASD in a Taiwanese sample   "
202199|NCT00494767|"     The drugs GSK189075 and GW869682 result in increased caloric losses. This study is     investigating how if taken over 8 weeks that affects weight loss, food intake and the     composition of the body. The body composition (fat,water, lean mass) is determined using a     new investigational MR technology.   "
202200|NCT00494780|"     To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP     (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients     with Follicular Lymphoma (FL)   "
202202|NCT00494806|"     Primary Objective:      1. Compare the duration of postoperative ileus (POI) duration (time to first flatus),     subjective reports of surgical and gas pain, postoperative pain medication (total milligrams     per 24 hours) and postoperative recovery time(length of stay) between two groups of abdominal     surgery cancer patients receiving either standard postoperative care or standard care plus     the rocking intervention.   "
202203|NCT00494819|"     Background: Attention-Deficit/Hyperactivity Disorder (ADHD), characterized by inattention,     hyperactivity, and impulsivity, is among the most common neuropsychiatric disorders worldwide     (5-10% at school age) and in Taiwan (7.5%). The DSM-IV ADHD consists of three subtypes:     predominantly Inattentive (ADHD-I), predominantly Hyperactivity/Impulsivity (ADHD-H), and     Combined subtypes (ADHD-C). Although the DSM-IV field trials indicate that the current     subtypes differ significantly on variables such as age of onset, gender ratio, and level of     social and academic impairment, little has been addressed whether the DSM-IV subtypes differ     neuropsychologically. Numerous researches have proved that stimulants (methylphenidate is the     only stimulant in Taiwan) are the most effective medication in treating ADHD. Although the     efficacy of methylphenidate on behavioral measures has been established in Taiwan, there is     no information about neuropsychological measures.      Specific Aims:        1. to validate ADHD subtype by neuropsychological measures; and        2. to investigate the efficacy of methylphenidate on the improvement of executive          functioning among children with ADHD.      Subjects and Methods: Participants will consist of 20 children with ADHD-C, 20 with ADHD-I,     10 with ADHD-H and 50 controls without ADHD in the age range of 7 to 10. The measures include     the psychiatric interviews (Chinese K-SADS-E), neuropsychological tests (WISC-III,     Cancellation Test, Digit Span, Trail Making Test, CPT, Circle Tracing Test),     self-administered rating scale (SNAP-IV), and investigator administered assessment (CGI and     Behavior Observation Ratings).      Anticipated Results: We anticipated that children in the ADHD and non-ADHD group will perform     differently on the neuropsychological tests with more deficits in neuropsychological     functions in the ADHD group. Also, we expected that methylphenidate will improve the     performance on the neuropsychological tests and reduce the behavioral symptoms of ADHD     children. Subtypes difference in the neuropsychological functions is also expected.   "
202204|NCT00494832|"     The purposes of this study are:        1. To evaluate the safety and efficacy of Dexmedetomidine as an adjunct for anesthesia          during spine surgery and        2. To investigate the influence of Dexmedetomidine on the evoked potentials.   "
202205|NCT00494845|"     Among mind-body therapies, there is evidence for an association between pain reduction and     mindfulness meditation. Mindfulness meditation provides a potentially safe, effective,     nonpharmacologic, noninvasive, simple method for pain relief and increased function that     could be used for the frailest older adult. Additionally, mindfulness meditation addresses     the multiple dimensions that are affected by chronic pain. The primary objective of this     study is to determine the impact of an 8-week mindfulness-based stress reduction program on     physical function and pain severity in community dwelling older adults with chronic low back     pain. Using a randomized controlled experimental design, 80 community dwelling older adults ≥     age 65 with chronic low back pain will receive either (1) the MBSR program, or (2) an 8-week     education program. Prior to initiating the program, immediately after the last program     session, and 6 months later, the following parameters will be assessed: (1) pain severity,     (2) disability/physical function, (3) objectively measured physical performance, (4)     psychosocial function (including mood, self-efficacy, self-rated health, coping, stress,     quality of life (QOL), mindfulness and pain-related fear), (5) sleep, (6) pain-related     appetite reduction and, (7) time and frequency of meditation. All measures are self-report     except for the physical performance measure.   "
202206|NCT00494858|"     This study will compare the effectiveness of two types of cognitive behavioral therapy in     treating adult women with the dysregulated subtype of bulimia nervosa.   "
202207|NCT00494871|"     This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke     prevention in patients with atrial fibrillation (originally described in Japanese).   "
202208|NCT00494884|"     This study will investigate efficacy and safety of vildagliptin in patients with low baseline     levels starting at an HbA1C level of 6.5% to support convenient early intervention with     combination therapies. In parallel, morning and evening dosing will be evaluated in this     patient population for the first time.   "
202209|NCT00494897|"     The objective of current protocol is try improve the results of chemotherapy treatment in     patients with ALL wich is not indicated the peripheral stem cell transplant in first     remission, with an intensive consolidation follow by re-inductions.   "
202316|NCT00496353|"     The purposes of this phase I portion are; 1) to evaluate the safety and tolerability of     MK2461 and 2) to determine the recommended phase 2 dose or doses of MK2461.      The purpose of the phase II portion is to evaluate the anti-tumor efficacy of MK2461.   "
202210|NCT00494910|"     The purpose of this study is to compare two types of group counseling for cancer patients:     Meaning-Centered counseling and Supportive counseling. Many cancer patients seek counseling     to help with the emotional burden of their illnesses. Counseling often helps them cope with     cancer by giving them a place to express their feelings. Meaning-Centered group counseling     is intended to teach cancer patients how to maintain or even increase a sense of meaning and     purpose in their lives, despite cancer. Supportive group counseling is intended to help you     cope with cancer by giving you a place to express your feelings and get support from other     cancer patients. The purpose of this study is to compare the benefits of these two types of     counseling approaches for cancer patients.   "
202211|NCT00494923|"     The Erlangen Glaucoma Registry is a clinical registry for cross sectional and longitudinal     observation of patients with open angle glaucoma (OAG) or glaucoma suspect, founded in 1991.     The primary aim is the evaluation of diagnostic and prognostic validity of morphometrical,     sensory and hemodynamical diagnostic procedures. No therapeutic studies are performed.   "
202212|NCT00494936|"     This study will determine the effects that HIV and hepatitis C virus have on thinking     abilities and whether the viruses affect brain chemistry.   "
202213|NCT00494949|"     The purpose of this study is to evaluate the safety and possible effectiveness of Hemospan     solution in patients undergoing elective orthopedic surgery who receive spinal anesthesia.   "
202214|NCT00494962|"     To determine the bioequivalence between two 5-mg tablets of lecozotan and the new 10-mg     tablet of lecozotan.   "
202215|NCT00494975|"     The purpose of this study was to confirm the efficacy of NB UVB phototherapy in alleviating     uremic pruritus and investigate the association between improvement of pruritus and change of     serum parameters, including routine biochemical data, immune profile and dialysis adequacy.   "
202216|NCT00494988|"     This trial is conducted in Asia. The aim of this trial is evaluate the remission rate in     newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with     insulin aspart and insulin NPH.   "
202218|NCT00495027|"     The objective of this randomized control trial is to compare the effectiveness of Stress     Inoculation Training (SIT), a well researched psychological treatment for Post Traumatic     Stress Disorder (PTSD), to that of the non-specific standard care provided in primary care     settings, called Supportive Counseling (SC), on individuals who were exposed to the September     11, 2001 terrorist attack on the Pentagon, or the immediate aftermath of this attack. Both     SIT and SC interventions will each be provided in one 2-hour session with eight weeks of     daily systematic web-based follow up to promote self-help. The primary hypothesis of this     study is that SIT will reduce the level of PTSD in participants relative to SCand to the     pre-treatment levels.   "
202219|NCT00495040|"     The goal of this clinical research study is to learn if escalated/accelerated proton     radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side     effects. The safety of this treatment will also be studied.      Objectives:      To assess the therapeutic efficacy and toxicities of proton radiotherapy with     escalated/accelerated dose for patients with medically inoperable stage I (T1-2, N0,M0)     NSCLC.      Primary goals:        1. Improve 2 years progression free survival at the primary site, and        2. reduce acute and chronic toxicity      Secondary goals:        1. Improve disease specific survival at 2 years.        2. Study the potential of pre- and post treatment PET/CT in predicting clinical outcome.        3. Study the role of biomarkers in predicting therapeutic response and toxicities.   "
202220|NCT00495053|"     The purpose of this study is to evaluate the safety of a new product that uses human gene     transfer (called hMaxi-K) when it is given to patients with overactive bladder. Human gene     transfer is a new type of therapy that is the process of placing genetic material (DNA or     RNA) into a person. The primary objective of this study is to evaluate safety parameters     occurring subsequent to administration of a single intravesical instillation of study drug.      Three different dose groups of hMaxi-K will be tested in this study consisting of 5000,     10,000 and 15,000 micrograms. hMaxi-K will be given as a single administration into the     bladder through a catheter. Each women's participation in the study will last for up to 24     weeks (followed by an additional 18 month follow-up period).   "
202221|NCT00495066|"     The primary objective of the study is to provide treatment with Ipilimumab to subjects who     have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who     have no alternative treatment options, and whose physicians believe, based upon available     data on benefit and risk, that it is appropriate to administer Ipilimumab at a dose of 3     mg/kg induction (with re-induction, if eligible), or for eligible subjects previously     enrolled in Ipilimumab studies CA184-042, CA184-078, CA184-087, MDX010-16, or MDX010-20.   "
202222|NCT00495079|"     This was a Phase 2, international, multicenter, open-label, single-arm trial evaluating     Marqibo (VSLI) in adult subjects with: 1) Ph- ALL or lymphoblastic lymphoma in second or     greater relapse; or 2) Ph- ALL or lymphoblastic lymphoma who failed 2 or greater treatment     lines of anti-leukemia chemotherapy. The original enrollment target for this study was     approximately 56 subjects. Per a protocol amendment, enrollment was increased from 56 to 65.      The primary objective of this study was to evaluate:      - The efficacy of the study treatment as determined by the rate of CR plus CR with incomplete     blood count recovery (CRi) in adult subjects with Philadelphia chromosome-negative (Ph-) ALL     in second relapse or adult subjects with (Ph-) ALL who failed 2 treatment lines of     anti-leukemia chemotherapy. Subjects must have achieved a CR to at least 1 prior     anti-leukemia therapy as defined by a leukemia-free interval of ≥ 90 days.   "
202223|NCT00495092|"     The aim of this study is to assess the efficacy of caffeine compared to placebo in     detoxifying cocaine dependent patients. Caffeine potentiation with biperiden will be also     studied.      108 with cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.)     plus biperidene (8 mg b.i.d.) or caffeine (300 - 1200 mg t.i.d.) with placebo or placebo     during 6 months.      Primary efficacy outcomes will be 1) patient comfort assessed with abstinence symptomatology,     craving for cocaine and mental status during detoxifying period, 2) study retention and 3)     cocaine use.      Brain dopamine system will be assessed thru IBZM-SPECT and the apomorphine test.   "
202226|NCT00495131|"     Chronic hepatitis C virus (HCV) infection is prevalent in the world, affecting 3% of the     world's population. The current standard of therapy is pegylated interferon and ribavirin,     reaching 54-63% of successful rates. In patients with HCV genotype 1 infection, a 48 week     course of combination therapy has achieved a higher successful rate that a 24 weeks course of     therapy. However, several studies in Taiwan have shown that a 24 week course of therapy has     comparable or even better response to a 48 week course of therapy in Western countries.     Therefore, whether a 48 week course of therapy can achieve a higher response to a 24 week     course of therapy in Taiwanese patients with genotype 1 HCV infection remains unclear.   "
202227|NCT00495144|"     This is a phase I, multi-center, open-label, dose-escalation study of TH-302 in patients with     advanced solid tumors. TH-302 is a hypoxia activated product designed to exploit the hypoxic     nature of tumors. The study is designed to establish the safety including the maximum     tolerated dose, the pharmacokinetics, and the anti-tumor activity of TH-302.   "
202228|NCT00495157|"     Asthma can be effectively controlled using inhaled corticosteroid medication. Treatment with     inhaled corticosteroids often requires periodic adjustments to medication dosing and     frequency levels. This study examines whether it is more beneficial to adjust corticosteroid     treatment based on asthma symptoms and/or biomarkers of lung function versus standard medical     guidelines.   "
202229|NCT00495170|"     The goal of this clinical research study is to learn if proton radiotherapy given with     standard chemotherapy (such as paclitaxel and carboplatin) can help to control locally     advanced NSCLC. The safety of this treatment will also be studied.   "
202230|NCT00495183|"     The aim of this study is to assess the efficacy of caffeine compared to placebo as a     maintenance treatment for cocaine dependence. Caffeine potentiation with biperiden will be     also studied.      Ninety patients with snorted/sniffed cocaine dependence will be randomized to receive     caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) caffeine (300 - 1200 mg t.i.d.)     with placebo or placebo during 10 days in an in-hospital setting.   "
202231|NCT00495196|"     The purpose of the trial is to investigate the cardiovascular response to peripheral     chemoreceptor stimulation in Congestive Heart Failure with Cheyne- Stokes Respiration   "
202232|NCT00495209|"     The use of complementary and alternative medicine (CAM) in the United States has increased     dramatically in the past 10 years. Nowhere is this trend more apparent than when one examines     CAM use by patients diagnosed with cancer. As with the general population, patients with     cancer typically use CAM-based modalities alongside their conventional cancer treatments.     Patients are often seeking a holistic approach to managing and preventing disease. Although     most patients will combine alternative approaches with conventional medicine, some patients     do in fact decline curative conventional treatments in favor of more non-toxic alternative     approaches. One such approach that patients combine with conventional medicine or use in     place of conventional medicine is qigong.      Qigong is a bioenergy therapy with a long history of therapeutic use for many diseases,     including cancer. Preliminary experiments and a review of the literature show that qigong     might improve the outcome for cancer patients. However, none of this research has been     confirmed in the peer-reviewed Western scientific literature. Although it is unlikely that     EQT will result in significant decreases in tumor size, patients are using qigong either as a     complementary approach, and sometimes even in place of conventional medicine, it is,     therefore, important for us to determine whether there is any merit to this treatment     modality. The goal of this pilot trial is to examine one form of medical qigong (external qi     therapy (EQT)) to determine feasibility. In an exploratory nature we will also examine any     changes in tumor size in women with breast cancer who are awaiting surgery.   "
202233|NCT00495222|"     The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic     Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ     anastomosis in subjects who are regaining weight after successful weight loss following     gastric bypass. Post-procedure weight will be followed to assess whether weight loss is     resumed.      The ESS is an FDA-cleared (510(k)) sterile, single-use, disposable suturing system indicated     for endoscopic placement of suture(s) and approximation of soft tissues. It is designed to     facilitate endoscopic gastrointestinal procedures.   "
202234|NCT00495235|"     The goal of this clinical research study is to find out if there is a link between insulin     resistance (or pre-diabetes) and endometrial cancer.      Primary Objective:      1. To determine the association between insulin resistance and endometrial cancer in women in     Harris County, Texas. 2. To assess the effect of body mass index (BMI) on the association     between insulin resistance and endometrial cancer.      Secondary Objectives:        1. To explore the association between polycystic ovarian syndrome (PCOS) and endometrial          cancer.        2. To assess the relationship between known reproductive risk factors, menstrual risk          factors, family history and endometrial cancer.        3. To explore the molecular changes associated with insulin resistance and PCOS on normal          endometrium and tumor tissue.   "
202235|NCT00495248|"     The aim of the study is to evaluate the effect of a group intervention programme for     community dwelling elders with stroke or TIA.The intervention is inspired by a Lifestyle     Redesign method developed in the USA. The study is conducted as a multi centre randomized     controlled trial. Participants are recruited from five hospitals and the intervention is     implemented at six to seven senior centres. The control group is offered physical activity at     the senior centre once a week. The intervention group is offered the same with addition of     the programme inspired by Lifestyle Redesign. The study will contribute to knowledge whether     the intervention will promote social participation and thriving in daily life and prevent     social isolation and depressive symptoms among community dwelling elders with stroke or TIA.   "
202297|NCT00496106|"     The purpose of the study is to:        1. Test the efficacy of psychosocial telephone counseling (PTC) for cervical cancer          survivors, compared to usual care.        2. Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer          patients who have received PTC, compared to usual care.        3. Examine the longitudinal relationship between PTC associated modulations of quality of          life (QOL) measures and biologic parameters (immune and neuroendocrine).   "
202298|NCT00496119|"     The goal of this clinical research study is to learn if proton beam therapy, with or without     photon beam radiation therapy, is effective in the treatment of skull base chordoma. The     safety of this treatment will also be studied.   "
202236|NCT00495261|"     In recent years, mindfulness meditation has been shown to be a promising approach for     alleviating emotional distress associated with chronic medical and psychiatric conditions and     in reducing relapse following treatment for depression. The applicability of mindfulness     meditation to problem gambling has not yet been explored. Mindfulness meditation may be     particularly suitable for this clinical disorder as it stresses a process-oriented,     metacognitive, approach to cognitive pathology in contrast to a content-focused approach,     characteristic of traditional approaches to treating cognitive psychopathology.     Gambling-related cognitive psychopathology is a well-known characteristic of problem gambling     and frequently the target of therapy. Although there is growing evidence that     cognitive-behavioral treatments are effective for gambling, outcomes may be improved by     teaching gamblers additional ways to cope with cognitive distortions that emphasize     metacognitive processes.   "
202237|NCT00495274|"     The purpose of this study is to select the formulation with the optimal pharmacokinetic     profile for an hypnotic drug to further develop in the market.   "
202238|NCT00495287|"     The study was set up to assess:        1. Standard-dose versus high-dose remission induction therapy. A standard ICE chemotherapy          vs sequential high-dose cytarabine, with appropriate supportive/prophylactic measures,          followed by morphological, cytogenetic and molecular monitoring of remission.        2. A risk-oriented postremission therapy: HR patients will be electively submitted to          allogeneic stem cell transplantation (allo-SCT), whenever possible (related/unrelated          donor/cord blood; ablative/non-ablative conditioning according to national and local          protocols and guidelines). Provided sufficient blood stem cells were previously          collected (>2x10e6/kg Cluster of Differentiation 34 cells), SR patients and HR patients          excluded from allo-SCT and aged 65 years or less will be randomized to: myeloablative          autologous blood stem cell transplantation vs non-myeloablative, multicycle, autologous          blood stem cell-supported high-dose cytarabine-based therapy.             -  HR/SR patients unable to be randomized because of inadequate blood stem cell yield               will receive intermediate-dose consolidation; patients aged >65 years will be               treated with age-adapted therapy.   "
202239|NCT00495300|"     This protocol will collect blood samples and medical information from patients who have had a     bone marrow transplant using cells from an unrelated donor identified through the National     Marrow Donor Program (NMDP). The NMDP has two programs in which patients can participate: the     Research Database Program and the Research Sample Repository.      Patients who have received a bone marrow transplant at the NIH or other institution from an     unrelated donor affiliated with the NMDP may be eligible for this study.      Participants in the NMDP Research Database program will have medical information about their     disease and their transplant sent to the NMDP before and after the transplant and once a year     for the rest of their life. The information will be used to help determine how well     transplant recipients recover from their transplant, how recovery after a transplant can be     improved, how access to transplant for different groups of patients can be improved and how     well donors recover from collection procedures.      Participants in the NMDP Research Sample Repository program will have a small blood sample     drawn from a vein in the arm just before they start taking medicines for the conditioning     regimen to prepare them for the transplant. The blood samples will be used to look at ways to     improve how patients are matched with their donors, to determine and evaluate the factors     that affect transplant outcome, and to help develop methods to improve tissue matching     between donors and recipients.   "
202240|NCT00495313|"     To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole     gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%   "
202241|NCT00495326|"     The purpose of this study is to determine whether the use of Nevirapine in HIV patients     already treated against tuberculosis by Rifampicin is as efficient and as well tolerated as     Efavirenz.   "
202242|NCT00495339|"     Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine     therapy of MDR TB.      Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.   "
202243|NCT00495352|"     Cigarette smoking represents a major health problem for patients suffering from     schizophrenia. Compared to the general population, schizophrenic patients are significantly     more likely to be addicted to nicotine. They also are more likely to be heavy smokers, and     tend to be exposed disproportionately to nicotine and other harmful ingredients in the     cigarette because of the observed tendency to smoke down to the very end. Further, smoking in     these patients may be associated with a higher risk for developing tardive dyskinesia All of     these factors render schizophrenic patients a particularly vulnerable group for the     detrimental effects of tobacco-related medical problems. Currently, there is little     information available regarding the efficacy and utility of smoking cessation treatment     methods, as well as factors that may predict patients' response to such treatments.      An important related issue is the influence of smoking, and its cessation, on the effects of     the medications most of these patients rely upon for the control of their psychiatric     symptoms. Although smoking has long been known to significantly alter the metabolism, and     thus the effects, of most antipsychotics, the extent and clinical significance of these     influences have rarely been assessed. It is unclear to what extent smoke cessation (as well     as initiation) changes the side effect profiles of these medications, and whether such     changes contribute towards the difficulties in patients' ability and/or willingness to stop     smoking.      In addition, except pharmacological intervention, readiness to change may be an important     factor affecting the outcomes of smoking reduction. Prochaska et al proposed the concept of     stages of change to predict the response of quitting behavior for substance use. A lot of     evidence support the stronger of readiness of change, the higher successful rate of quitting     can be reached. Yet these results are largely found in many non-pharmacological intervention     and smoking cessation programs for general population. Till now, no available study solely     focus readiness of change quitting smoking behavior in NRT treatment for chronic     schizophrenic patients. Thus, we have an a great interest in examining the association     between the stages of change and the outcomes of smoking-cessation along with reduction among     schizophrenic patients receiving transdermal nicotine patches.      In order to begin addressing these important issues, this application proposes to utilize     state-of-the-art methodologies derived from the field of pharmacogenetics, molecular biology     and clinical trials, to (1) examine short-term and long-term efficacy of standard treatment     methods, such as the use of nicotine patches, in this population; (2) identify factors that     might predict treatment responses; and, (3) examine the interactions between smoking and the     effect of antipsychotics, as well as how such interactions might affect smoking cessation.     (4) to examine the predictive value of the stages of change on smoking cessation and     reduction outcomes in schizophrenic patients receiving different doses of nicotine     replacement therapy (NRT) and bupropion as implemented in a randomized trial.   "
202244|NCT00495365|"     The purpose of this study was to evaluate hemoglobin stability in subjects who had received     darbepoetin alfa for a minimum of 3 months prior to study entry who were then converted to     epoetin alfa at the same dosing frequency to maintain a hemoglobin level of 12 plus or minus     1 g/dL (range 11-13- g/dL).   "
202245|NCT00495378|"     The purpose of this study was to determine if alternate dosing of Epoetin alfa was effective     in maintaining hemoglobin levels in patients with chemotherapy related anemia.   "
202246|NCT00495391|"     The purpose of this study is to determine if nitazoxanide in combination with peginterferon     alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in patients that     have previously failed to respond to treatment with peginterferon and ribavirin.   "
202247|NCT00495404|"     Although the use of opioid medications has gained increasing acceptance as a treatment option     for chronic pain, there is little empirical research concerning long-term outcomes with this     patient population. Several important questions concerning the use of opioids have yet to be     examined in controlled studies. These include: determination of the most effective dosing     regime, specification of the risk factors for medication abuse, and identification of     patients most likely to achieve long-term benefits. Despite the lack of empirical data, the     clinical literature to date yields two general approaches to the use of opioid treatment with     chronic, nonmalignant pain. The first approach dictates that due to risk of addiction,     tolerance, and insensitivity to large doses, opioid medications should be carefully     controlled, with minimal and stable dosing as the eventual goal of treatment. The second     approach, fostered by the beneficial use of opioids in the treatment of cancer pain,     maintains that risk of addiction and abuse has been exaggerated. Proponents of this approach     suggest that under-medication is a significant cause of treatment failure and non-compliance     in chronic pain patients, and that prescription guidelines should emphasize patients� reports     of adequate relief, regardless of dosage.   "
202248|NCT00495417|"     The purpose of this study is to assess the tolerability and safety of repeated subcutaneous     injection of a single dose of Affitope AD01 in patients with mild to moderate Alzheimer's     Disease.   "
202249|NCT00495430|"     The primary purpose is to test intersubject variability and establish the qualitative     features of normal VRI images and the range of normality of the VRI quantitative lung data     values that may be used to differentiate normal from abnormal breath sound distribution. Our     hypothesis was that VRI breath sound images of healthy subjects are similar in a qualitative     and quantitative manner.   "
202250|NCT00495443|"     The purpose of this study is to determine whether a new laser system provides better safety     and efficacy than existing lasers in popular cosmetic procedures such as hair removal,     treatment of cosmetically disturbing vascular lesions and rhytides.   "
202251|NCT00495456|"     The burden of cardiovascular disease (CVD) is considerable, despite many advances in     diagnosis, clinical management and drug therapy. The World Health Organization estimates 30%     of global deaths are attributable to CVD and whilst mortality rates in developed countries     are falling, it remains the largest single cause of death (WHO, 2007). Nineteen out of every     100 deaths in Australia are attributed to CVD, with an annual cost of $1.47 billion (AIHW,     2006).      Assessing the risk of future cardiovascular events is traditionally based on a number of     'risk-factors' determined by observational clinical studies such as the Framingham cohort.     Recent evidence however invalidates their use in both the highest and lowest risk groups and     raises questions about applying such methods in changing risk-behaviour. A considerable     number of new risk markers have surfaced in recent years (including various biomarkers, pulse     wave velocity and measures of arterial function). Unfortunately their long-term predictive     capacity is largely unknown, particularly when compared with existing risk factors.      The aims of this study are to provide objective longitudinal data for a wide variety of risk     markers both in current use and in development. Participants of current on-going clinical     studies at will be approached to lengthen their observation period for the purposes of     determining long-term clinical outcomes.      Standard clinical observations and data obtained within the participant's enrolled studies     will be collated into an electronic database. All existing and future studies must have     individual approval from an appropriate ethics committee with signed consent. The baseline     studies and follow-up assessments of this cohort will be correlated with cardiovascular     events, hospitalizations and mortality. In addition, volunteers can be directed to     appropriate clinical studies in CVD, thereby enhancing recruitment, encouraging good quality     clinical studies and advancing knowledge of cardiovascular disease prevention.   "
202252|NCT00495469|"     This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of     doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in     treatment-naive subjects with type 2 diabetes mellitus   "
202253|NCT00495482|"     Euthanasia and assisted dying are of growing interest for patients with incurable diseases.     The possible methods are widely discussed by patient-societies, physicians, lawyers,     theologians and philosophers. During the last years several opinion-polls were conducted with     healthy people or medical stuff, but no surveys were conducted to get the attitude of     incurable ill patients.      The hypothesis of the investigators' study is: Palliative Care Medicine is a better option     for incurable ill patients than an assisted suicide.   "
202254|NCT00495495|"     Caries means demineralization with the formation of cavities and pulp symptoms and necrosis     as an end result. The acids in the mouth are mainly produced by oral bacteria like     Streptococcus mutans from bacterial biofilms adhering to the tooth. Ozone has been shown to     have a very strong bactericidal effect on bacteria causing dental caries. Baysan et al     reported that there was a statistically significant reduction of streptococci in root caries     lesions and saliva samples after ozone application. The positive clinical effect of ozone     with respect to arresting caries progression and the remineralization of caries has been     shown in vitro and in vivo. In an in vivo study, Baysan and Lynch found that the application     of ozone resulted in a significant reduction of bacterial contamination as well as a     reduction in size and severity of root caries lesions. In a subsequent study, Baysan and     Lynch reported that the severity of root caries lesions was significantly reduced after ozone     application as measured by electrical conductance and laser fluorescence. In several studies,     the caries reducing effect of ozone was measured with biochemical methods in root surface     caries lesions, the biofilm and saliva after ozone application. See Citation section for     references.      The objectives of this multi-center clinical study were to determine: (1) the effectiveness     of the HealOzone in stopping the progression of fissure caries; and (2) the oral soft tissue     safety of the ozone system.   "
202255|NCT00495508|"     A) for the treatment of uncomplicated malaria during second and third trimester pregnancy to     oral Quinine hydrochloride. The PCR-corrected adequate clinical and parasitological response     (ACPR) on day 42 is considered as the primary efficacy criterion. Newborns will be followed     for growth and development indicators.   "
202256|NCT00495521|"     The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release     oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times     daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will     resolve an acute flare of ileocecal Crohn's disease.   "
202257|NCT00495547|"     The primary objective is to evaluate the efficacy of the treatment in response rate terms.     Otherwise this study wants to evaluate the safety of the treatment.   "
202380|NCT00490048|"     Ulcerative colitis is a systemic disease we assume that extra intestinal involvement as we     describein our study( Fireman Z, Osipov A, Kivity S, Kopelman Y, Sternberg A Fireman E:     Assessment of pulmonary involvement in Crohn’s disease by induced sputum. Am J Gastroenterol     2000;95(30):730-734. )   "
202258|NCT00495560|"     Induction termination of pregnancy (second trimester abortion) has a median time of 14 hours     from the start of medication (misoprostol) to expulsion of the fetus. The objective of this     study is to evaluate a method of 'priming' on the length of induction termination of     pregnancy. Priming refers to the use of medication to ready the cervix and uterus so that     the uterus is more sensitive to medication and contracts more effectively, and also refers to     softening of the cervix so that there is less resistance to dilation. Priming is used     extensively before induction of labor for term pregnancy and is also used extensively before     surgical abortion in second trimester. We would like to add priming the evening before     induction to the usual treatment and evaluate whether the length of the induction process is     shortened. Women are admitted to the hospital in the morning to start misoprostol medication,     and unless expulsion occurs within 8-10 hours, need to stay overnight.      The study design is to give the priming dose 12 hours before admission. The outcome of     interest is the induction time from the first dose on misoprostol in the hospital to     expulsion of the fetus.      This study aims to assess whether the use of misoprostol as a priming agent would be     beneficial with women who undergo induction termination of pregnancy.   "
202259|NCT00495573|"     The purpose of the study is to evaluate the pattern of viral shedding after beginning     treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with     the pattern of viral shedding during an untreated clinical recurrence of genital herpes.   "
202260|NCT00495586|"     The purpose of this study is to determine the effectiveness of antibiotic therapy for     patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease.   "
202261|NCT00495599|"     The central hypothesis of our study is that metabolic and hemodynamic improvements following     gastric bypass surgery are mediated by downregulation of inflammation-related adipokines     produced by the intra-abdominal adipose tissue such as Visfatin.   "
202262|NCT00495612|"     This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with     a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with     placebo, reduces the degree of bronchoconstriction induced by environmental cat dander     exposure in patients 18-65 years old with stable, moderate asthma and a history of cat     dander-induced asthma symptoms.   "
202263|NCT00495625|"     An open label multi-site phase II clinical trial of dose escalated sunitinib malate given     orally once daily on days 1-28 of each 42-day cycle. Treatment will be continued until there     is either disease progression or cumulative or acute toxicity which in the opinion of the     treating physician compromises the ability of the patient to receive treatment or patient     desire to stop treatment.   "
202264|NCT00495638|"     The study will look at the risk factors for pulmonary hypertension (high blood pressure in     the lungs) in children and adolescents with sickle cell anemia (SCA) and examine the role of     hypoxia (oxygen shortage) in the disease. In patients with SCA, red blood cells become     sickle-shaped and tend to form clumps that get stuck in blood vessels, blocking blood flow to     the limbs and organs. Blocked blood vessels can cause pain, serious infections, and organ     damage. Many patients with SCA also develop pulmonary hypertension.      Children and adolescents with SCA or Chuvash polycythemia (another blood disorder that     carries an increased risk for pulmonary hypertension) may be eligible for this study.      Participants undergo the following procedures at the beginning (baseline) and end of the     study:        -  History, physical examination and blood tests .        -  Echocardiography (ultrasound study of heart function).        -  Transcranial doppler (brain ultrasound study to measure brain blood flow).        -  Lung function tests.        -  6-minute walk (measure of the distance covered in 6 minutes of walking).      In addition, patients are followed by telephone or by clinic visits every 6 months for a     review of their medical history and medications. A physical examination is also done at 12     months.   "
202265|NCT00495651|"     The Temprano trial is based on the following assumptions:        -  ART initiation at CD4 counts <800/mm3 could significantly reduce the probability of          severe HIV-related morbidity or death in the medium term.        -  Tuberculosis and tuberculosis-related deaths are likely to represent a considerable          proportion of morbidity and mortality among HIV-infected patients with high CD4 counts          in sub-Saharan Africa. Therefore, 6-month Isoniazide Prophylaxis for Tuberculosis (IPT)          and early ART could enhance each others efficacy.   "
202266|NCT00495664|"     Coronary-stent implantation is commonly performed for treatment of acute myocardial     infarction (MI). Drug eluting stents (DES) among selected patients have been shown to reduce     target lesion revascularization (TLR) after percutaneous coronary intervention (PCI).     However, there is no studies comparing titanium-nitride-oxide (TITANOX) coated stent with     paclitaxel-eluting stent (PES) in acute MI.   "
202267|NCT00495677|"     To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral     doses of PF 00232798 in HIV-positive patient volunteers.   "
202268|NCT00495690|"     Title: Impact of daily zinc supplementation to infants born with low birth weight on     mortality and severe disease requiring hospitalization Background: Zinc supplementation was     shown to prevent diarrhea and pneumonia in 6 month to 3 year old children. Little is known     about the impact of zinc supplementation of low birth weight (LBW) babies during first 6     months of life.      Objective: The objectives were to determine the impact of daily zinc administration at 1RDA     (5 mg) of elemental zinc to LBW infants on severe morbidity requiring hospitalization and on     all cause mortality.      Design: In a double blind randomized placebo controlled trial 2012 hospital-born infants with     a birth weight <2500 g were randomly assigned to receive zinc or placebo for 6 months. Zinc     group received 5 mg elemental zinc as acetate daily from 4 weeks age. Cause specific     hospitalization deaths, episodes of diarrhea, acute respiratory infections, other illness,     visits to health care providers and hospital OPDs were ascertained by in-depth interview and     from documents like prescriptions, hospital tickets, medicine cartons at 3 and 6 months of     age.      Results: Number of infants with one or more diarrhea episodes was less by 17% (95% CI: 1% to     35%) in the zinc group but the numbers for ARI were similar in the two groups. The     hospitalization rates due to all causes or diarrhea or ARI were similar in the two groups.     Twelve in the zinc group and 9 in the placebo group died during 4 weeks to 6 months (p=0.36).     We observed no significant difference for gain in weight and length at 3 months and 6 months     between the groups. In a subgroup of infants the mean serum zinc concentration in the zinc     group was 27% higher (p=0.004) than the placebo group.      Conclusion: Hospital born, low birth weight infants do not seem to derive worthwhile benefit     from daily zinc supplementation of recommended dietary allowance for zinc in terms of     morbidity and growth during first six months of life.   "
202299|NCT00496132|"     This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of     single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed     after or were refractory to treatment with a purine nucleoside analogue-containing regimen.     The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II     expanded treatment cohort, with enrollment of additional patients in order to expand safety     experience and collect preliminary anti-leukemia activity data.   "
202269|NCT00495703|"     Cognitive dysfunction following chemotherapy is an adverse treatment effect that impacts the     quality of life for many cancer survivors receiving this adjuvant therapy. A strong body of     evidence now indicates that that the initiation of a regular exercise program, at levels that     are readily achievable by most adults (3-5 d/wk, 30-45 min/session), can improve cognitive     function. Importantly, the domains of cognitive function that are enhanced by exercise     participation are the same domains that are negatively affected by chemotherapy. Accordingly,     we propose a 2 year research program that seeks to develop and test a safe, simple, and     effective exercise intervention to optimize cognitive function following chemotherapy. To     begin this research, we will: 1) conduct a randomized exercise intervention trial among     cancer survivors that report persistent cognitive problems following chemotherapy (n=60), 2)     explore possible mediators and moderators of the intervention on cognition in order to begin     to understand how the intervention may work and for whom it may be most effective, and 3),     conduct a cross-sectional study comparing cancer survivors enrolled in the trial (n=60) and     matched controls (n=40) to evaluate the cognitive status among survivors in the intervention.     We hypothesize that six-months of regular exercise will enhance cognitive function among     cancer survivors, and that cancer survivors reporting cognitive dysfunction will have lower     objectively measured cognitive performance than adults who have not received chemotherapy. To     our knowledge this study would be the first to examine the influence of regular exercise     participation on cognitive function among cancer survivors that experienced cognitive     difficulties following chemotherapy.   "
202270|NCT00495716|"     The purpose of this study is to determine what effect suppressive therapy has on sexual     behavior and quality of life among persons with genital herpes (HSV) who have multiple sex     partners.   "
202271|NCT00495729|"     Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7     days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and     cognition function tests.   "
202272|NCT00495755|"     The CD52 antigen, which is targeted by alemtuzumab, is highly expressed on mature T     lymphocytes, monocytes and monocyte-derived dendritic cells as well as on mature B cells. Due     to its more promiscuous effect on immune cells, alemtuzumab not only targets antibody     producing B lymphocytes as does rituximab, but also targets alloreactive T lymphocytes and     dendritic cells that also contribute to the complex pathogenesis of chronic GVHD.      Our hypothesis is that alemtuzumab will be effective in the treatment of chronic GVHD through     its promiscuous depletion of alloreactive T lymphocytes, dendritic cells as well as antibody     producing mature B-lymphocytes.   "
202273|NCT00495768|"     The purpose of this study is to conduct a randomized controlled trial of an 8-visit     non-pharmacologic group intervention in reducing the severity of depressive symptoms in     veterans who receive IFN and ribavirin for the treatment of Hepatitis C. We hypothesize that     over the first 6 months of treatment with IFN and ribavirin for the 45 patients who receive     the 8-visit intervention early in the course of treatment in addition to usual care     (experimental group) will have lower scores on the CES-D, a standard depression rating scale,     than the 45 patients who receive only usual care (control group).   "
202274|NCT00495781|"     The purpose of the study is to define laboratory parameters which are best suited to diagnose     functional iron deficiency. Functional iron deficiency is a condition where - due to the lack     of iron bioavailability - the patient suffers from symptoms such as fatigue and weakness, or     his/her capacity to produce red blood cells is reduced.   "
202275|NCT00495794|"     Background: Good blood pressure (BP) control among patients with diabetes is essential in     preventing diabetes complications and has been found to be not only cost-effective but     cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP     control. Among these poorly controlled patients, over 65% have problems with medication     adherence or inadequate intensification of medications. We therefore propose a partnership     with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored     clinical pharmacist-based intervention to improve medication management, adherence and BP     control.      Objectives: The specific objectives of this implementation study are: 1) To evaluate the     effects of the intervention on blood pressure (primary outcome) and glycemic and lipid     control (secondary outcomes); 2) To assess the impact of the intervention on patients'     adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity     of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to     usual care; 4) To evaluate the level of attainment of intervention implementation, examine     the process of intervention implementation, and determine the potential for sustainability.   "
202276|NCT00495807|"     Psychological implications expressed pivotal effects on daily activities. Postoperative pain     management is always encountered varying influence from the ambience of surgical wards,     especially the nurses. We hypothesized that nurses' negative or positive words would produce     unexpected role in pain management, which might be a strong factor resulting in the failure     of postoperative analgesia.   "
202277|NCT00495820|"     The purpose of the study is to determine the efficacy of methylphenidate over placebo in     treating apathy in patients with Alzheimer's dementia. Apathy is one of the earliest and most     profound disturbances that occur in Alzheimer's dementia (AD).      Hypotheses: 1. Methylphenidate (MPH) will improve apathy significantly more than placebo in     AD.      2. Successful treatment of apathy will improve Instrumental Activities of Daily Living     (IADLs), and caregiver burden.   "
202278|NCT00495833|"     Overview: This study uses communications strategies delivered through the traditional     emergency medical response system to increase the proportion of low-income adults who obtain     blood pressure screening and follow-up information for hypertension treatment options. The     project will test the effectiveness of source personalization and tailored messaging in     motivating potentially high-risk people, identified by 911 responders, to come to a local     fire station for hypertension screening.      Specific Aims: The specific aims are:        1. Test the effectiveness of three health marketing approaches to motivate high-risk          people, identified via 911 responders, to come to a local fire station for hypertension          screening. The mailed marketing approaches vary personalized risk information and          personalization of source.        2. Test the effectiveness of two mailing interventions (blood pressure kits with and          without promotional gifts) to increase blood pressure monitoring among patients who have          come to a fire station for a second blood pressure check.   "
202279|NCT00495846|"     The hepatocellular carcinoma (HCC) represents more than 5% of all human malignancies, with     more than 500,000 deaths per year (1). In Campania region, mortality for HCC is 2 times     higher than in the rest of Italy because of a higher locally prevalence of hepatitis-C virus     infection.      Development of HCC in liver cirrhosis is associated with increased DNA synthesis and     regeneration of hepatocytes (2). Hepatocyte growth factor, the transforming growth factor-α,     the fibroblast growth factor are well studied (3,4) while the insulin-like growth factor     system (IGF-I, IGF-II and their binding proteins) has been less investigated. IGF-I and     IGF-II modulate growth, metabolism and cell differentiation and have specific receptors in     the liver (5). IGF-I levels in the upper normal range have been associated with an increased     risk to develop prostate cancer (6), breast cancer (7) and colon cancer (8). Some data report     increased expression of IGF-II in HCC (9,10) and others suggest a role of increased IGF-I     bioavailability in HCC (11). We reported increased IGF-I/IGFBP-3 ratio in patients with HCC     compared with those with cirrhosis with a similar liver function, so suggesting increased     IGF-I bioavailability in HCC (12).      There is no currently medical treatment for patients with advanced HCC which has a very poor     prognosis (survival <6 months). Because of limited liver function, classical chemotherapy     cannot be applied (13). In patients with HCC without cirrhosis, surgery is possible only in     5% while in those with cirrhosis first-line treatment is still questioned as survival is <50%     three years after operation. Patients suitable for local resection of HCC are only those with     Child-Pugh's hyper A liver function class, who are a minority (14-16). Percutaneous     resection treatments may treat approximately 70%-90% of tumors with maximal diameters of <3     cm (15,17-19).      Somatostatin analogues are indicated in patients with neuroendocrine tumors expressing     somatostatin receptors type 2 and 5 and has excellent safety profile. In advanced HCC, some     studies demonstrated beneficial effects (20,21) while some others did not (22,23).      Only a few data are available on somatostatin receptor expression in HCC (24,25).     Somatostatin analogues have also a clear-cut inhibitory effect on circulating IGF-I levels     with a potential additional effect in delaying HCC progression.   "
202280|NCT00495859|"     Patients with endstage liver disease characteristically are malnourished which is associated     with poor outcome. Formulas enriched with arginine,ω3 fatty acids, and nucleotides     potentially improve their nutritional status. This randomized placebo-controlled double blind     multicenter clinical trial with longterm preoperative supplementation with such an enriched     formula will evaluate evaluate effects of such formulas on patients' quality of life,     survival, and posttransplant morbidities.   "
202281|NCT00495872|"     The goal of this clinical research study is to find the highest tolerable dose of valproic     acid in combination with either dasatinib, erlotinib hydrochloride, lapatinib, lenalidomide,     sorafenib, or SU011248 (sunitinib malate) that can be given to patients with advanced cancer.     The safety of each combination of the study drugs will be studied as well.   "
202282|NCT00495885|"     The purpose of this study is to assess efficacy and safety of volinanserin in the population     of patients complaining of sleep maintenance insomnia. The objective of the substudy is to     assess glycemic control in the subgroup of patients with type II diabetes mellitus.   "
202283|NCT00495898|"     The main objective of this study is to assess the safety and effectiveness of the CYPHER     sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary     artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients     with manifest diabetes mellitus. Both stents are mounted on the Raptorâ Rapid Exchange Stent     Delivery System.   "
202284|NCT00495924|"     The purpose of this study is to determine whether early recurrence after curative resection     of ductal pancreatic adenocarcinoma can be explained by either dissemination of cancer cells     during intraoperative tumour manipulation, post-operative systemic immune suppression,     alteration of biological properties of circulating cancer cells or a combination of these.   "
202285|NCT00495950|"     The goal of this study is to measure the amount of limb swelling (lymphedema) that sometimes     occurs after melanoma treatment, and to find out how people feel and react to the diagnosis     and treatment of melanoma.   "
202286|NCT00495963|"     Background and Objectives: There is a need to validate and suggest easy and less costly     diagnostic method for diagnosis of ventilator-associated pneumonia in developing country. The     study was performed to compare available methods for the diagnosis and to characterize the     organisms causing VAP.      Design and Methods: All patients on mechanical ventilation for more than 48 hours and     simplified CPIS ≥ 6 were enrolled prospectively. Four diagnostic procedures, endotracheal     aspiration (ETA), blind bronchial sampling (BBS), blind bronchoalveolar lavage (blind BAL)     and bronchoscopic BAL (BAL) were performed in same sequence within 12 hours. The bacterial     density ≥ 104 cfu/ mL BAL samples were taken as reference standard.   "
202287|NCT00495976|"     Common cold medicines are often formulated as a hot drink yet there is no evidence in the     public domain that presenting the medicine as a hot drink has any impact on symptom severity.   "
202288|NCT00495989|"     This is an evaluation of potential differences in saliva composition and dental calculus     composition between orally fed and tube fed individuals in an institutional environment.   "
202289|NCT00496002|"     The objectives of this study are to compare in nucleoside treatment-naïve subjects, the     efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as     monotherapy, for 48 weeks and 96 weeks.   "
202290|NCT00496015|"     The purpose of this trial is to assess if the rate of febrile reactions following the     co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant     vaccines is lowered when paracetamol is given prophylactically and to assess the impact of     pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage     compared to control group receiving meningococcal conjugate vaccine (GSK134612).      This protocol posting deals with objectives & outcome measures of the booster phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT00370318).   "
202291|NCT00496028|"     This study will comprise 2 parts, a dose escalation phase and a dose expansion phase. The 2     phases are part of a single study and described by this single protocol. Patients entered     into the dose escalation phase will not be entered into the expansion phase. All subjects     must be suitable for treatment with either carboplatin and/or paclitaxel.   "
202292|NCT00496041|"     This is a Belgian prospective multicentre registry on the performance of the Smart stent in     the superficial femoral artery according to the new tasc II-classification.   "
202293|NCT00496054|"     To observe the safety, tolerability and immunogenicity of the administration of 3 doses of     rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.   "
202294|NCT00496067|"     The primary objective of this study is to evaluate the safety and effectiveness of Doppler     guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated     symptoms.   "
202295|NCT00496080|"     The objective of this study is to evaluate the safety and effectiveness of Doppler guided     uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.   "
202300|NCT00496145|"     Type II diabetes is a growing health concern for Latinos who not only have a higher incidence     of the disease but also suffer great morbidity. At the same time due to poverty, language,     low literacy and lack of continuity of care, this population is largely excluded from current     diabetes education programs. To assist with this problem we propose to evaluate 1) a     community-based, peer-led Spanish Diabetes Self-Management Program that is culturally     appropriate and acceptable based on self-efficacy theory, and 2) the effects of long-term,     self-tailored educational reinforcement offered by means of automated telephone disease     management messages. Should this research be successful it will provide an evidenced based     public health diabetes education model for use with Latino populations throughout the United     States.   "
202301|NCT00496158|"     The objectives of this study are to compare in nucleoside treatment-naïve subjects, the     efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as     monotherapy, for 48 weeks, 72 weeks, and 96 weeks.   "
202302|NCT00496171|"     The purpose of the study is to determine the most effective formulation of HAL for release of     hexaminolevulinate to the cervical epithelium at different doses.   "
202303|NCT00496184|"     To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked     localized Vulvodynia (vestibulitis, vestibulodynia).   "
202333|NCT00496587|"     The goal of this clinical research study is to learn if the combination of 3 drugs     (gemcitabine, capecitabine, and bevacizumab) can help to control metastatic or unresectable     renal cell carcinoma. The safety of this drug combination will also be tested.   "
202652|NCT00493649|"     The purpose of this research study is to find out what effects (good and bad)     docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand     name: Herceptin, or H) has HER2+ breast cancer.   "
202304|NCT00496197|"     The purpose of this study is to further evaluate the safety and effectiveness of intravenous     anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis,     which is a fungus infection of the blood or tissue. Currently the drug is approved for     treatment using a daily dose of IV medication until 14 days after the fungus disappears from     the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is     administered for 5-28 days followed by oral antifungal medication. Study patients will be     assessed for response to treatment throughout the study drug treatment period.   "
202305|NCT00496210|"     This study will explore predictors of how caregivers might adapt to children diagnosed with a     pervasive developmental disorder (PDD), including autism, Asperger s syndrome, childhood     disintegrative disorder, Rett s disorder or other not specified PDD. PDD presents particular     challenges for caregivers because of the communication and socialization challenges of     affected children and because of the uncertainty surrounding the cause, prognosis and     recurrence risks.      People 18 years of age or older who are the primary caregiver for a child diagnosed with a     PDD may be eligible for this study. Participants fill out a survey, either online or in hard     copy, that includes information in the following categories:        -  How being a caregiver for a child with a PDD has impacted the caregiver.        -  How much control the caregiver feels that he or she or others have over certain aspects          of their child s PDD.        -  What the caregiver thinks caused the child s PDD.        -  What coping techniques the caregiver uses in caring for a child with a PDD.        -  How uncertain the caregiver feels about his or her child s PDD.        -  What the caregiver feels about him- or herself as a caregiver of a child with a PDD.        -  General questions about the caregiver, his or her family and the child with a PDD.   "
202306|NCT00496223|"     This is a combination Phase I/II design that explores the toxicity and activity of Sunitinib     and Dacarbazine (DTIC) for metastatic melanoma. The initial Phase I part of this trial will     consist of a dose escalation of sunitinib while keeping the DTIC dose constant. If no DLT is     seen, this dose will be the suggested Phase II trial dose. If less than 2 disease responses     are seen, patients will not be enrolled any further, and the study will be considered     negative for activity. If a clinical response is seen, patients will continue to be enrolled.   "
202307|NCT00496236|"     This study is looking at the safety and tolerability of TNFeradeä Biologic combined with     conventional once daily radiation therapy in elderly or frail patients with new onset locally     advanced head and neck tumors.   "
202308|NCT00496249|"     Many younger men are diagnosed with prostate cancer. These patients are often choosing     radiation therapy as their primary treatment. The effect of this therapy on fertility will     have a direct impact on their decision about therapeutic options and fertility preservation.     The researchers hypothesize that when patients are treated with radiation for localized     prostate cancer, infertility can occur due to direct damage to seminiferous tubules affecting     sperm quality.   "
202309|NCT00496262|"     This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and     clot strength (maximum clot firmness [MCF]) in subjects with congenital fibrinogen     deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen     when a fixed dose of human fibrinogen concentrate was administered.   "
202310|NCT00496275|"     To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or     Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced     or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.   "
202311|NCT00496288|"     Women with BRCA germline mutations face a very high risk of developing breast cancer during     their lives. It was shown that for carrier patients, breast conservation, comprising of     lumpectomy followed by whole breast radiation, was not associated with increased risk of     ipsilateral breast cancer recurrence as compared with non carriers (10-15% over 10 years),     especially if they also underwent prophylactic oophorectomy. Yet their risk of subsequent     contralateral breast cancer was significantly increased, reported as high as 25-30% over 10     years and 40% over 15 years, as compared to 3% and 7% respectively in non carriers. The     reduction in ipsilateral disease was attributed to radiation of the affected breast. We     propose that for breast cancer patients with BRCA germline mutation that choose to have     breast-conserving therapy and refuse prophylactic contralateral mastectomy, prophylactic     radiation to the contralateral breast may reduce the rate of subsequent contralateral breast     cancer and offer an option for risk reduction.   "
202312|NCT00496301|"     Main Objective:      To evaluate progression-free survival in patients with unresectable renal cell carcinoma     (RCC) treated with a combination of gemcitabine, capecitabine, and sorafenib.   "
202313|NCT00496314|"     A study which assesses the physician's comfort level and satisfaction when using the e2TM     Collector compared to the Spatula/SytoBrush technique.   "
202314|NCT00496327|"     To observe the safety and tolerability of the administration of VARIVAX in varicella history     negative Indian children 12 months to 12 years of age.   "
202317|NCT00496366|"     Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that     is HER2/neu-positive will take part in this study. This type of breast cancer has a high     amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer     and normal cells. This family of receptors is important for cell growth and is found in many     tumor types. The purpose of this research study is to compare an approved treatment for     breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an     experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic     breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used     to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering     with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered     investigational, which means the drug has not been approved by the US Food and Drug     Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may     slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However,     this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine     may help stop cancer cells as well as or better than capecitabine alone. Other studies have     demonstrated activity and tolerability of lapatinib either alone or in combination with     capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and     lapatinib. A treatment period will be 21 days long. This period is known as a cycle. All     medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day     1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken     daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take     lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue     to receive these medications unless they experience severe, serious and/or excessive side     effects, the cancer becomes worse, the subjects wishes to no longer participate or the study     doctor feels it is not in the best interest to continue treatment.Tests and procedures such     as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at     one or more of the following time points: before the study starts, before each cycle, every 6     and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.   "
202653|NCT00493662|"     To evaluate the efficacy of two lubricating eye drops for the treatment of dry eye signs and     symptoms.   "
202318|NCT00496379|"     The purpose of this research study is to determine the effects (good and bad) of     ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that     is thought to work by interfering with the ability of cancer cells to grow and divide. It is     a part of a group of drugs called epothilones which appear to cause shrinkage of cancer in     some patients with breast cancer. It is generally difficult for chemotherapy to enter the     brain. However, it is believed that ZK219477 crosses into the brain. We are also studying     whether an investigational MRI scan procedure may eventually help to predict which patients     will benefit from ZK219477.   "
202319|NCT00496392|"     Primary:      • To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®)     (hereafter Actiq) in the management of breakthrough pain in cancer patients.      Secondary:        -  To compare patients' general impression and preference of NF and Actiq        -  To explore the relationship between NF doses and dose of current opioid for breakthrough          pain (BTP) and the relationship between dose of NF and of background opioid        -  To assess safety and tolerability of NF   "
202320|NCT00496405|"     The endothelial growth factor (VEGF), has been implied in the genesis of diverse Neovascular     disease. In the industrialized and developing countries, the main cause of blindness is the     diabetic retinopathy. Bevacizumab (Avastin, genentech, Inc., San Francisco, California, the     USA) is a drug.In the last years its use off-label, in ophthalmology field, has become     popular. This is due to its proven safeness and effectiveness for the treatment of diverse     ocular diseases. A lot has been speculated about the systemic absorption of Bevacizumab. It     is for that reason that the objective of this study is the systematic and random revision of     the fellows eyes, of the patients programmed for the intravitreal administration of     Bevacizumab, with bilateral macular edema. In such a way that the therapeutic value in the     fellow eye of bevacizumab can be determined   "
202321|NCT00496418|"     The study aims to prove differences or equalities in outcome for patients operated with or     without a peristomal mesh in the sublay position when establishing a permanent colostomy.   "
202322|NCT00496431|"     This is a multi-center, open label, phase II study testing ITF2357 in a population of very     high-risk relapsed/refractory Hodgkin's lymphoma patients.      The patients will receive 50 mg ITF2357 four times a day at 6-hour intervals in fed     conditions for 28 consecutive days unless evidence of progressive disease, presence of     unacceptable adverse events or patient's request to discontinue treatment occurs.      Decision regarding the continuation of ITF2357 will be made on:        -  the basis of tumor reassessment upon completion of cycle defined as above and not later          than 7 days and        -  the occurred toxicity (if any). If complete response or partial response or          stabilization of disease after first cycle, without concomitant relevant toxicities is          observed, the treatment may continue as long as there is no evidence of progressive          disease or appearance of unacceptable adverse events. In any case the treatment shall          not exceed 84 days of drug intake overall (i.e. 12 weeks).      Treatment will be administered on an outpatient basis and patients will be followed regularly     with physical and laboratory tests, as specified in the protocol; in case of hospitalization,     the treatment will be continued or interrupted according to the Investigators' decision.      The study will accrue 23 patients evaluable for efficacy and the anticipated duration of the     study is about 18 months.   "
202323|NCT00496444|"     Primary Objective:      1. To evaluate side effects and maximum tolerated dose of azacitidine and valproic acid in     patients with advanced cancer.      Secondary Objectives:        1. To perform a preliminary assessment of the histone acetylation and DNA methylation          effects of this combination on peripheral blood mononuclear cells (PBMC).        2. To assess the clinical anti-tumor activity (objective response including complete and          partial responses) of this combination in patients with advanced cancer, in a          descriptive fashion.   "
202324|NCT00496457|"     The purpose of this study is to assess the efficacy and safety of TRO19622 administered PO     daily for 6 weeks compared to placebo administered PO daily in patients with painful     peripheral diabetic neuropathy.   "
202325|NCT00496470|"     The purpose of this study is to investigate the effect of combined treatment with Symbicort     and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in     patients with severe COPD.   "
202326|NCT00496483|"     A three sequence, open-label, multi-center, prospective, study in stable kidney transplant     patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of     LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.   "
202327|NCT00496509|"     A Phase I, Open-Label Study To Assess The Effect of ZD6474 (ZACTIMA) On Vascular Permeability     In Patients with Advanced Colorectal Cancer and Liver Metastases.   "
202328|NCT00496522|"     The goal of this clinical research study is to learn if proton beam therapy, with or without     photon beam radiation therapy, is effective in the treatment of skull base chondrosarcoma.     The safety of this treatment will also be studied.   "
202329|NCT00496535|"     The primary objective of the first phase is to determine the safety, the maximum tolerated     dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied     combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in     patients with recurrent head and neck cancer (RHNC). All chemoradiotherapy is administered on     a week-on/week-off schedule. The primary objective of the second phase II is to determine     the locoregional control rate at 24 months.   "
202330|NCT00496548|"     The purpose of this study is to determine whether urinary PGE-M levels correlate with Crohn's     disease activity and to compare how well urinary PGE-M correlates with other non-invasive     biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin.   "
202331|NCT00496561|"     The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on     clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life,     lung function, chosen markers of inflammation, induction of regulatory lymphocytes, bronchial     hyperreactivity with methacholine, and presence and type of allergy after two years of SIT in     children with asthma.   "
202332|NCT00496574|"     The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on     clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life,     lung function, bronchial hyperreactivity with methacholine, and presence and type of allergy     after three years of SIT in children with asthma.   "
202334|NCT00496600|"     This is an unblinded, dose escalation study of patupilone in combination with RAD001 in     subjects with advanced cancer to find the maximum tolerated dose of each drug. The purpose of     this study is to see what doses of RAD001 and patupilone are safe to use when the two drugs     are used at the same time. Other goals in this study are to learn about the effect of RAD 001     and patupilone on tumor growth; to find out what amount of RAD001 is present in the blood     when it is combined with patupilone; to learn about proteins in the blood that may predict or     show an effect of RAD001 or patupilone and to learn if any changes are seen in the tumor with     the type of test called a PET scan.Subjects will be assigned to a dosing group. The dose of     patupilone and RAD001 a subject gets depends on when they enter onto this study. The initial     subjects in the study will take the lowest doses of RAD001 and patupilone. At least 3     subjects will be treated in each dosing group starting with the smallest dose. If there are     few or easy to handle side effects, the next group of at least 3 people to enter in the study     will get the next higher dose. This continues until the highest dose of the study drug is     found that does not cause serious or hard to treat side effects. Both the subjects and the     study doctor will know which dose is assigned. In this study, RAD001 will be given as tablets     to take with water. RAD001 will be taken for either 7, 14, or 21 days of each 21 day cycle     depending on which dosing group is assigned. If taking RAD 001 and patupilone on the same     day, then RAD 001 will be taken with water however prior to receiving patupilone.Patupilone     will be given by an intravenous injection (through a vein) for 20 minutes on Days 1 or day 6     of the 21-day cycle. The patupilone dose will be based on height and weight. Blood tests     (approximately 1-3 teaspoons) will be done every week. Every six weeks a CT scan or MRI will     be done to assess the tumor size. Subjects will continue to receive RAD001 and patupilone as     long as the tumor is stable or shrinking, and not having too many side effects from     treatment.   "
202335|NCT00496613|"     The purpose of this study is to learn more about how chemotherapy affects an individual's     thinking abilities (cognition). Some research has shown that chemotherapy can cause changes     in cognition in breast cancer survivors. However, it is not clear why this change occurs. In     this study, the investigators will look to see if damage to DNA is related to these changes     in cognition. Specifically, the investigators want to see 1) if women who have been treated     with chemotherapy have more DNA damage than healthy women; and 2) if DNA damage is related to     cognitive problems in breast cancer survivors and healthy women.   "
202336|NCT00496626|"     This is a China registration study. A randomized, double-blind, placebo-controlled     immunogenicity and safety study in Chinese female participants aged 9 to 45 years and male     participants aged 9 to 15 years. Approximately 600 participants will be randomized in a 1:1     ratio to receive either vaccine or aluminum-containing placebo. Each participant received one     injection at each visit at Day 1, Month 2, and Month 6. Vaccine or placebo was given as a     0.5-mL intramuscular injection. Serum will be collected from all participants to evaluate     immune response against anti-Human Papillomavirus (HPV) 6/11/16/18 with Luminex Assay. At     Month 2, Month 6, Month 7, subjects will be evaluated for any new medical condition or health     concerns and Serious Adverse Experiences throughout the study. The primary objective is to     evaluate the vaccine-induced serum anti-HPV 6, 11, 16 and 18 antibody titers following 3-dose     regimen of Gardasil® compared with placebo.   "
202337|NCT00496639|"     Arteriovenous grafts are used as the vascular access in 40-50% of hemodialysis patients.     Grafts are prone to recurrent stenosis (narrowing) and thrombosis (clotting). Graft clotting     is usually due to a narrowing at the site where the graft joins the vein. The standard     treatment is to remove the clot and angioplasty the narrowed area. The long-term outcome is     not good, lasting only about 1 month. Placing a stent (a small metallic, PTFE covered,     spring) at the narrowed site may keep the graft open longer. Principal investigator's     preliminary research data suggest that placing a stent at the stenotic site prolongs graft     patency following thrombectomy, as compared to conventional angioplasty.      This is a single-center, randomized clinical trial, in which patients with a clotted graft     with underlying stenosis at the venous anastomosis of the graft will be allocated to     thrombectomy + angioplasty (control group) or to thrombectomy + stent placement (study     group). The primary endpoint will be primary (unassisted) graft patency. The secondary     endpoints will be secondary (assisted) graft patency and overall access-related costs.   "
202338|NCT00496652|"     The purpose of this study is to determine whether the addition of the fully human EGFr     antibody zalutumumab to primary curative radiotherapy increases locoregional control in     Squamous Cell Carcinomas of the Head and Neck.   "
202339|NCT00496665|"     The purpose of this research study is to determine the safety and tolerability of the     combination of Zactima with metronomic chemotherapy. Zactima is an oral anti-angiogenesis     drug, which means it fights cancer by cutting off a tumor's blood supply. Thus, the drug     starves the tumor by preventing the delivery of nutrients and oxygen. Metronomic chemotherapy     is low dose oral chemotherapy pills which are taken daily. Unlike traditional chemotherapy,     metronomic chemotherapy is thought to fight cancer like Zactima, by cutting off the blood     supply to tumors. Because the dose is very low, the side effects are generally mild and very     different from those with higher dose chemotherapy given by vein.   "
202412|NCT00490464|"     The purpose of this research is to explore ways to improve and simplify control of blood     pressure in patients with SAH or ICH. This research will be done by comparing tow different     medications that are routinely used to help control blood pressure. None of the medications     used in this study nor any procedures performed are experimental.   "
202340|NCT00496678|"     The University of Rochester, Department of Family Medicine, funded by the National Cancer     Institute will train community health workers to guide patients through the cancer care     system. The project will help to teach patients how to communicate more effectively with     their health care team in order to understand the treatment options available to them.     Although not widely available, it is believed patient navigation programs are beneficial.      This research study will evaluate how well this tool works, especially among those who     experience disparities in health care. The goal is to determine if having a trained navigator     shortens the time between an abnormal test result and a definitive diagnosis and between a     definitive diagnosis and completion of treatment for breast and colorectal cancer patients.     The project also will evaluate whether navigation improves the ability to communicate with     the doctor, patient satisfaction with care and quality of life.   "
202356|NCT00496886|"     Fibromyalgia (FM) is a disabling chronic disorder characterized by widespread muscle pain,     fatigue, and multiple tender points, specific places on the body that become painful with     only slight pressure. Pain associated with FM cannot be explained medically, often leading to     a delayed diagnosis and delayed treatment. The purpose of this study is to evaluate how the     nervous system, specifically the brain, processes pain in women with FM.   "
202357|NCT00496899|"     The study is an open label feasibility study. The purpose of the study is to evaluate the     ease of use of the Cervical ITR in terms of duration of attachment and number of detachments.   "
202802|NCT00504153|"     This phase II trial is studying dasatinib to see how well it works in treating patients with     previously treated metastatic colorectal cancer. Dasatinib may stop the growth of tumor cells     by blocking some of the enzymes needed for their growth.   "
202341|NCT00496691|"     This 4-year competing continuation will extend the follow-up for 750 subjects enrolled in a     randomized interventions trial, Project STYLE: HIV Prevention for Youth with Severe Mental     Illness (R01, MH 63008). Extending the follow-up from one year to 36 months will 1) discern     the long-term impact of the Project STYLE interventions and 2) permit complex modeling of the     predictors and trajectories of sexual health (delay of sex) and risk (incident STIs).     Adolescents, particularly those in mental health treatment, are at risk for HIV because of     sexual and substance behaviors. Parent-child communication about sexual topics and parental     supervision are associated with delays in the onset of sexual activity and more responsible     sexual behavior; thus, the parent project, Project STYLE, is a randomized trial that is     evaluating the comparative efficacy of three interventions: a) family-based HIV prevention     intervention, b) adolescent-only HIV prevention intervention, and c) general health promotion     intervention. This multi-site project (Rhode Island Hospital, Emory University, and the     University of Illinois at Chicago) is enrolling an ethnically/racially/geographically diverse     group of 750 adolescents in outpatient mental health treatment and their parents. Subjects     receive a full day group intervention on the day of randomization, return in two weeks for an     individual session, participate in a half day booster session three months later, and are     assessed six and 12 months after the intervention. This application offers a unique     opportunity to assess this already ascertained sample at three additional points (24,30, and     36 months). This is important because few studies have examined the longer-term predictors of     the delay of sex and incident STIs over 36 months using a comprehensive array of family     functioning, family monitoring/communication, and trauma history. Additionally, this     continuation will provide important data concerning the long-term impact of Project STYLE's     theoretically based HIV prevention programs which are designed to maintain safe sexual     behaviors. The Family-Based program has increased parent/adolescent sexual communication and     reduced adolescent unprotected sex after six months and extended assessment will determine     whether these benefits are maintained over time.   "
202342|NCT00496704|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, capecitabine, and oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when     given together with capecitabine and oxaliplatin as second-line therapy and to see how well     it works in treating patients with advanced colorectal cancer previously treated with     irinotecan.   "
202343|NCT00496717|"     Calcium scoring of the coronary arteries is use as a predictor of coronary stenosis. The aim     of this study is to measure the calcium scoring of the abdominal aorta using an helicoidal     fast scan and to correlate this measurement with classical cardiovascular risk factors and     newer parameters reflecting vascular rigidity, like pulse velocity measurement.   "
202344|NCT00496730|"     Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting     on such increasing populations like metabolic syndrome patients with Vytorin® in korea.     Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian     population with metabolic syndrome.   "
202345|NCT00496743|"     The purpise of this study was to determine the effect of low-dose (4 Gy) total skin electron     beam therapy as a second-line treatment of stage IB-II mycosis fungoides.   "
202346|NCT00496756|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in     treating patients with metastatic or unresectable kidney cancer.   "
202347|NCT00496769|"     The purpose of this clinical research study is to determine whether apixaban is more     effective than acetylsalicylic acid in the prevention of strokes associated with patients     with atrial fibrillation. The safety of this treatment will also be studied.   "
202348|NCT00496782|"     The purpose of this pilot study is to determine whether there is a correlation between viral     load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a     failing regimen, and the R5 result of the TrofileTM assay at screening.   "
202349|NCT00496795|"     Molecular markers predicting response to dose dense chemotherapy with epirubicin and     docetaxel in sequence for locally advanced breast cancer      Protocol summary.      Principal Investigator Per E Lonning, Professor, Section of Oncology, Department of Medicine      Collaborators. Dept of Surgery - Responsible: Turid Aas, Consultant Surgeon Dept of Molecular     Biology - Responsible: Professor Johan Lillehaug Dept of Anatomy and Cellular Biology -     Responsible: Professor Rolf Bjerkvig      Participants. Dept of Oncology Gun Anker, Consultant Oncologist Stephanie Geisler, Consultant     Oncologist Jurgen Geisler, Consultant Oncologist      Type of Study Phase II, Translational research      Scientific aims: Addressing factors predicting response to dose intensive epirubicin followed     by docetaxel sequential therapy      Treatment regimen: epirubicin 60 mg/m2 on a 2 weekly basis x 4 followed by docetaxel 100     mg/m2 2-weekly x 4.      Patients: Breast cancer patients below 65 years of age suffering from large (>4 cm largest     diameter, non-inflammatory and / or N2-N3) primary breast cancer.      Clinical aim: Assessing responsiveness to this dose intensive regimen.      Number of patients to be enrolled: 60 - 100   "
202350|NCT00496808|"     Primary Objectives:        -  To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation          rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS)        -  To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu          over-expressing DCIS   "
202351|NCT00496821|"     The purpose of this study is to determine the safety, tolerability and efficacy of intranasal     ALN-RSV01 versus placebo, administered once daily for 5 days to a healthy male volunteers     experimentally inoculated with RSV   "
202352|NCT00496834|"     The primary objective of this study is to evaluate efficacy, arterial stiffness measured by     Pulse Wave Velocity (PWV) of Losartan potassium group compared to Carvedilol group after 24     weeks of treatment in patients with the essential hypertension.   "
202353|NCT00496847|"     PERIOGEN, containing rhPDGF and -beta-TCP, promotes gingival healing and corrects periodontal     defects. This study will test the safety and efficacy of PERIOGEN in the treatment of     periodontal disease   "
202354|NCT00496860|"     This is a Phase 1, open-labeled, non-randomized, multi-center, competitive enrollment and     dose-escalation study of ALT-801, the study drug. The purpose of this study is to evaluate     the safety, determine the maximum-tolerated dose (MTD) and characterize the pharmacokinetic     profile of ALT-801 in previously treated patients with progressive metastatic malignancies.     ALT-801, a recombinant fusion protein with a interleukin-2 (IL-2) component, has a targeting     mechanism that recognizes tumor cells with a specific tumor marker.   "
202355|NCT00496873|"     The goal of the clinical research study is to learn if treatment with a combination of three     drugs, Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin), will help to     control the disease in patients with previously untreated non-Hodgkin's lymphoma, CLL, or     bulky lymphoma. The safety of this treatment will also be studied.   "
202358|NCT00496925|"     We examine the usage of Dopamine blockers in OCD patients. We want to examine their frequency     of usage, compare the course of the disease between those who receive and those who do not     receive Dopamine blockers, and efficacy of the treatment.      The study will be done in two stages: 1. Collecting information the usage of Dopamine     blockers from 150 OCD patients' files. 2. interviewing 60-70 patients to see the difference     those who receive and those who do not receive Dopamine blockers in their current severity of     disease.   "
202359|NCT00496938|"     The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus     Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on     clinical outcomes in the treatment of female patients with de novo coronary artery lesions,     and the characterization of the female population undergoing stent implantation with a XIENCE     stent.   "
202360|NCT00496951|"     Symptoms of Neonatal Abstinence Syndrome (NAS) can be attributed largely to dysfunction of     the autonomic nervous system in opiate exposed neonates. Vagal tone is a readily available     measure of autonomic nervous system functioning. NAS is a widely variable disorder with     poorly understood pathophysiology; while all opiate exposed infants will exhibit some signs     and symptoms of NAS, only approximately ½ have severe enough symptoms to require     pharmacologic therapy. This research seeks to determine the relationship between infant vagal     tone and NAS severity. The determination of a link between newborn vagal tone and NAS     severity could result in the prediction of infants at risk for severe NAS and provide these     infants and mothers with intensified services and early treatment, thereby shortening the     course of NAS in the infant.   "
202361|NCT00496964|"     The purpose of this study is to determine whether the use of botulinum toxin A injected into     the lateral thigh muscle improves knee function and reduces knee pain secondary to     patellofemoral syndrome. The study hypothesis is that botulinum toxin + specific exercises     will be superior to specific exercises alone in improving knee function and reducing knee     pain in individuals with patellofemoral syndrome.   "
202362|NCT00496977|"     The trial is a randomised trial comparing annual CT screening for lung cancer with no     screening in 4104 smokers and former smokers between the age of 50 and 70 years. The goals     are: 1) to evaluate if annual CT screening can reduce lung cancer mortality by more than 20 %     (in collaboration with the NELSON trial in the Netherlands, 2) to evaluate psychological     effects of screening including the effects of false positive diagnoses, and 3) to evaluate     possible effects on smoking behaviour. The trial is funded in full by the Danish Ministry of     Interior and Health.   "
202363|NCT00496990|"     This is a two group randomized design that will compare a novel therapy package (i.e.,     Research supported treatment intervention, Contingency-based voucher incentives for the male     partner's drug abstinence, Specialized MI couples counseling) to standard care for helping     drug using partners of drug dependent pregnant women obtain and maintain drug abstinence.     Participants will be followed for 22 weeks and have scheduled twice weekly urine sample     collection and all participants will have follow-up interviews post-study entry.   "
202364|NCT00497003|"     The aim of this study is to evaluate the effect of the two different beta blockers metoprolol     and carvedilol on endothelial function in patients with either type two diabetes or chronic     heart failure.      Hypothesis: 1* Carvedilol compared to metoprolol has a favourable effect on endothelial     function.      2* Carvedilol compared to metoprolol has a favourable effect on insulin stimulated     endothelial function.      The study is conducted as an open parallel group study. Endothelial function and insulin     stimulated endothelial function was evaluated before and after a two months treatment period     with either of the two beta blockers.   "
202365|NCT00497016|"     A number of patients with hypertension have increased central sympathetic activity. Statins     seem to inhibit central sympathetic output. This study assesses the effect of statins on     central sympathetic activity in hypertension patients.   "
202366|NCT00497029|"     This purpose of this study was to evaluate effectiveness of a risk-based dental caries     prevention program conducted by dental personnel at an urban pediatric primary care clinic     serving largely low-income residents of Baltimore, Maryland, and to appraise this program as     a model for similar urban pediatric settings.   "
202367|NCT00497042|"     The study’s primary goal is to assess the safety of the SAF (Self Adjusting File) device for     root canal treatments.      The study’s secondary goal is to evaluate the effectiveness of the SAF device for root canal     treatments   "
202368|NCT00497055|"     Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual     behavior among men who have sex with men (MSM), putting meth-using MSM at extraordinarily     high risk for transmitting or acquiring HIV. This study is a randomized, double-blind,     placebo-controlled trial of the medication aripiprazole for methamphetamine-using     individuals, including MSM, and will assess efficacy, acceptability, tolerability, safety,     and adherence to study medication.   "
202369|NCT00497068|"     The primary objective of the proposed study is to evaluate the efficacy of tobacco     abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives     for reducing or eliminating tobacco use during pregnancy in methadone treated women. In     addition, the impact that this intervention has in reducing the incidence and severity of     methadone associated neonatal abstinence syndrome will also be examined.   "
202370|NCT00497081|"     Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual     behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or     acquiring HIV. This study of intermediate size (60 participants) and length (3 months of     follow-up) will assess the efficacy of mirtazapine in reducing methamphetamine use among     high-risk MSM.   "
202382|NCT00490074|"     The purpose of the trial is to evaluate the effect upon immune system of two regimens of     preventive HIV vaccination in healthy adult volunteers. Volunteers will be vaccinated by     DNA-C and NYVAC-C vaccines, and the immune changes will be assessed, as well as safety of the     vaccines. Volunteers will be followed during 72 weeks.   "
202383|NCT00490087|"     The study aims to evaluate the long-term efficacy and prognosis of hysteroscopic resection     and coagulation of the base of endometrial polyps with focal atypia in fertile women.   "
202803|NCT00504166|"     The purpose of this study is to evaluate the changes in bone structure as determined by     magnetic resonance imaging measurements among early postmenopausal women after 24 months of     treatment with alendronate, 70 mg once a week as compared to placebo   "
202371|NCT00489931|"     This study will evaluate the safety and effectiveness of a vaccine to prevent avian influenza     (bird flu). About 25 to 50 million cases of influenza occur a year in the U.S., leading to     150,000 hospitalizations and 30,000 to 40,000 deaths. Globally, a pandemic influenza may be 1     billion flu cases, with 3 to 5 million cases of severe illness and up to half a million     deaths annually. There is potential threat of a pandemic from emerging virus strains for     which the population has little or no preexisting immunity. Avian influenza A (H5N1) viruses     causing serious disease have emerged recently, affecting domestic and wild bird populations.      Patients ages 18 to 60 who are in good health and not pregnant or breast feeding may be     eligible for this study. The study will be done at the NIH Clinical Center by staff of the     Vaccine Research Center. It will last about 32 weeks for each person. A traditional needle or     a needle-free device called Biojector 2000 will be used. Intramuscular (in the muscle) and     subcutaneous (in fat below the skin) delivery of vaccine via Biojector is cleared for use by     the Food and Drug Administration and is not considered investigational. Intradermal (in the     skin) delivery of vaccine by Biojector in this study is deemed investigational but has been     evaluated in humans before, and found safe and well tolerated in other trials.      There will be about 10 clinic visits in this study, and it is important to stay on schedule.     Visits are about 2 hours, though on injection days, visits are about 4 hours. Injections are     given on day 0 and at weeks 4 and 8. The vaccine is given by injections in the skin on the     upper arms. Clinic staff will observe patients for 30 minutes after each vaccination. One to     2 days after the first injection, there will be a clinic visit. One to 3 days after the     second and third injections, patients need to telephone clinic staff to report on how they     are doing. Patients will complete a diary card at home, recording temperature and symptoms,     and looking at the injection site daily for 5 days. Patients should report any side effects     to one of the study physicians or nurses as soon as possible. They will return to the clinic     2 weeks after each injection. A needle-free system uses the pressure of carbon dioxide,     instead of a needle, to inject the vaccine into the skin. Discomfort can result from either     the needle-free device or the needle. There may be stinging, pain, soreness, swelling,     bruising, or a small cut in the skin.   "
202372|NCT00489944|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking blood flow to the tumor     and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such     as tamoxifen and cisplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving sunitinib together with     tamoxifen and cisplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving sunitinib     together with tamoxifen and cisplatin works in treating patients with high-risk ocular     melanoma.   "
202373|NCT00489957|"     An echocardiogram, also called a cardiac ultrasound or echo, is a medical test that takes     pictures of the heart using sound waves. It shows images of the structures of the heart     without using radiation. During the last year, the FDA has approved a new technology called     Speckle Tracking that can look at the heart wall motion and contraction (pumping or     squeezing) abnormalities. The study will also employ tissue Doppler and 3-Dimensional echo     and uses the same echocardiographic machines which are used right now. The machines are     upgraded with the new software application. This new technology is currently being used in     adults, but unfortunately, there is almost no published data about normal heart function in     infants and children using this technology. It is known from other technologies that the     developing child's heart is not the same as an adult.      The investigators wish to study this new technology and compare it to other technologies     currently being used.   "
202374|NCT00489970|"     The purpose of this study is to evaluate the persistence of antibodies against all the     vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to     assess immunogenicity and safety of another dose of Boostrix, administered in this study.      This protocol posting deals with objectives and outcome measures of the extension phase. The     objectives and outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT00346073).   "
202375|NCT00489983|"     This study is for elderly patients who haven't been given prior chemotherapy or for patients     who cannot be treated with platinum based chemotherapy. The patients who are eligible for     this study will have been diagnosed with advanced or metastatic non-small cell lung cancer.     The patients will be randomly assigned to one of two treatment options: single agent     pemetrexed or single agent pemetrexed with single agent gemcitabine following right after the     pemetrexed treatment.   "
202376|NCT00489996|"     The purpose of this study is to evaluate response rate of the 3 week versus 4 week treatment     of gemcitabine with cisplatin as the first line treatment for non-small cell lung cancer     patients in China.   "
202377|NCT00490009|"     The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with     relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).   "
202378|NCT00490022|"     The purpose of this research study is to understand the effects of a male hormone normally     made in the body called Dihydrotestosterone (DHT) on the prostate gland that is located under     the bladder. The knowledge gained from this study may be used to help in the future to     develop a safe male hormonal contraceptive to prevent pregnancy, in the safe treatment of low     male hormone levels in men, and in the treatment and prevention of diseases of the prostate.      The investigators will be giving DHT in a gel form, to be applied to the skin, or a placebo     gel (with no active drug in it). The investigators want to see the effects of DHT on levels     of hormones in the blood and in the prostate gland itself. In addition, the investigators     will be studying the effects of DHT on the cells and genes expressed within the prostate.      The effect of DHT on the prostate is not known. Some studies suggest blocking production of     DHT in the prostate helps growth of the gland with aging (a condition known as benign     prostatic hyperplasia, or BPH for short) and may prevent prostate cancer. On the other hand,     DHT administration may shrink the prostate, suggesting it may be beneficial for some men.     Therefore, further studies looking at the effect of DHT on the prostate are needed.   "
202379|NCT00490035|"     This study will evaluate the efficacy and safety of Brivaracetam to support the submission     file in the indication of adjunctive treatment in adolescents and adults with partial onset     seizures.   "
202413|NCT00490477|"     Aim of the study is to verify whether Polymyxin-B hemoperfusion protects from renal     dysfunction in patients with severe sepsis from gram negative infection.   "
202381|NCT00490061|"     We propose to combine lapatinib with RT alone in patients with locally advanced head and neck     cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the     efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression     (TTP) in this group of patients. In addition, we will determine the 2-year locoregional     control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these     patients. We will also evaluate the profile and frequency of late toxicity, specifically     mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with     locally advanced head and neck squamous cell carcinoma (HNSCC).   "
202890|NCT00505349|"     The overall goal of this study is to evaluate the impact of cognitive training on blood     levels of neurotrophic factors in adults.   "
202384|NCT00490100|"     This study will evaluate the safety and effectiveness of insulin-like growth factor-1 (IGF-1)     to treat patients with X-linked severe combined immunodeficiency (XSCID). Those who have     XSCID lack white blood cells that protect their bodies from invasion by all types of germs.     IGF-1 is the main hormone responsible for the body's growth and metabolism. As a medication,     IGF-1 is Increlex[(Trademark)] (mecasermin),      Patients ages 2 to 20 who have not yet begun puberty, have a diagnosis of XSCID, and are     shorter than the 3rd percentile for their age may be eligible for this study. This study will     last about 3 years, and patients' visits will be scheduled at 3-month intervals. Patients     will have a physical history and exam, X-rays, electrocardiogram, blood tests, and body     measurements.      Patients will take estradiol orally for 2 days, to help avoid false results of growth hormone     (GH) levels in blood samples. Then provocation testing is done, with two tests back to back.     It determines blood levels of GH and the body's response to testing with drugs called     arginine and clonidine. Patients are admitted to the pediatric inpatient unit and will have     an intravenous (IV) line placed in the arm. Arginine is given by IV over 30 minutes, and     blood samples are taken. Right after arginine testing, the clonidine tablet is given. The     IGF-1 generation test is then done to see if the body makes IGF-1 as a product in response to     injections of GH for 5 consecutive days. This test does not require that patients are     inpatients, but after Day 8, patients must be admitted to the pediatric unit to have blood     sampling, start Increlex injections, and start close monitoring of blood sugar levels. They     will learn how to do a self-injection and follow other advice. They will complete records     about the injection site, symptoms, and side effects-keeping records for at least the first 2     days after going home, with each dose change, and as needed. Patients stick their fingertip     and place a small drop of blood on a blood sugar monitoring strip. The strip is put into a     glucometer-a small hand-held device to measure the blood sugar level. Patients will be     instructed to always have a source of sugar available in case blood sugar is too low.   "
202385|NCT00490113|"     To determine whether pyridoxamine can decrease oxalate excretion in subjects who have normal     oxalate excretion (but who have had kidney stones), and in subjects who have primary     hyperoxaluria.   "
202386|NCT00490126|"     The goal of this clinical research study is to collect information on patients who had or are     going to have laparoscopy performed at M. D. Anderson. Researchers want to use this     information to learn the effects of laparoscopic surgery on patients over time.   "
202387|NCT00490139|"     This is a randomised, open label multi-centre phase III study comparing the activity of     lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus     lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2     overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of     two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will     be randomised to one of four treatment regimens within each design schema.      The primary objective of this study is to compare disease-free survival (DFS) in patients     with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one     year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned     design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks,     according to assigned design) versus trastuzumab in combination with lapatinib for one year     (52 weeks). Secondary objectives include treatment comparisons with respect to overall     survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence     of brain metastasis, and analyses conducted separately for cohorts of patients defined by     presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or     absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring     Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the     comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary,     indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to     demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS).     The IDMC also stated that the other three arms (trastuzumab alone, sequential     trastuzumab/lapatinib arm and the combination arm) should continue as planned with no     changes.   "
202388|NCT00490152|"     ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability,     and attitudes among sexually active young women   "
202389|NCT00490165|"     This is a retrospective chart review of patient records at the University of Mississippi     Medical Center. We are not actively recruiting patients for this study. Recent animal studies     we conducted showed that periapical abscesses during pregnancy cause a systemic inflammatory     response in the mother. Also due to the increase in TNF-alpha (an inflammatory cytokine) the     mother also become insulin resistant and thus developed gestational diabetes. Periodontal     inflammation has been shown in the research to lead to low-birth weight and pre-term birth.     We are looking retrospectively to see if an association exists in charted data between     periapical and periodontal inflammation and adverse pregnancy outcomes.   "
202390|NCT00490178|"     The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose     combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia   "
202391|NCT00490191|"     This study tested whether a dose regimen of growth hormone based on body weight is equivalent     or better than starting with a low dose and gradually increasing the dose according to     individual patient needs. Efficacy of the two regimens were assessed from changes in body fat     measured by dual-energy x-ray absorptiometry (DXA) scanning, performed at the beginning of     the study and at the completion of the study eight months later.   "
202392|NCT00490204|"     Study objective is to verify the superiority of CTZ DS to the placebo groups in the change of     total nasal symptom score (TNSS) over the total treatment period from the score of the     baseline assessment period.   "
202393|NCT00490217|"     Spontaneous bacterial peritonitis (SBP) is a severe complication of ascites in cirrhotic     patients. Under clinical experience, this condition seems to be more uncommon in Finland. The     aim of this study was to measure the incidence of SBP in consecutive patients with ascites     requiring hospitalization in a Finnish University Hospital.   "
202394|NCT00490230|"     Primary Objectives:      Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the     cosmetic outcome compared with no treatment (natural healing)   "
202414|NCT00490490|"     The purpose of the study is to assess the response rate of patients with relapsed or     refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma     to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy     (XRT).   "
202395|NCT00490243|"     The present study was conducted to determine the effects of four week treatment with     budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in     children with atopic asthma on lung function: forced expiratory volume in one second,     mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique,     plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and     clinical symptoms.   "
202417|NCT00490529|"     Mantle Cell Lymphoma is a sub-type of Non-Hodgkin's Lymphoma which is generally considered     incurable with current therapy. Our goal is to accrue 59 patients who receive an autologous     vaccine against their individual lymphoma after undergoing stem cell transplantation. Our     hope is that vaccination will prolong the time which patients will stay in remission from     their disease.   "
202607|NCT00501917|"     Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in     patients with acute myocardial infarction who receive intracoronary infusion of mobilized     peripheral blood stem cell in comparison with patient who treated with conventional measures     and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF     alone.   "
202396|NCT00490256|"     Even though the lower part of the body does receive some blood supply during Cardiopulmonary     Bypass(CPB) surgery, it may not be enough. As a result of this lowered blood supply, there     are complications associated with CPB and clamping of the aorta. These include complications     with the stomach, intestines and kidneys.      The hypotheses of this study are that increased lower body perfusion during aortic arch     reconstruction will decrease intestinal ischemia and the incidence of necrotizing     enterocolitis, improve renal function in the postoperative period, and shorten both intensive     care unit and hospital length of stay.      The purpose of this research study is to provide the lower part of the body and its organs     with possibly more blood supply with a modified form of cardiopulmonary bypass and see if     this additional blood supply helps to decrease complications of the kidney, stomach and     intestines.   "
202397|NCT00490269|"     This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on     withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety,     pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and     smoked marijuana to determine if there are potential significant drug interactions before     conducting outpatient studies.   "
202398|NCT00490282|"     The goal of this clinical research study is to use computed tomography (CT) scans to measure     and guide your radiation therapy. Researchers want to learn if the CT scans can be used to     adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor     that may occur as a reaction to radiation therapy. Researchers also want to see if magnetic     resonance imaging (MRI) scanning can detect certain changes in the tumor any earlier than     with standard tests.   "
202399|NCT00490295|"     Brain injury occurs in one-quarter to one-half of congenital heart defect infants during the     perioperative period. A blood test using a biomarker to diagnose brain injury would be     important.      Postoperative cerebral ischemia may be decreased by inotropic support, ventilation, medical     management aimed at increasing oxygen delivery to the brain. Currently there are no FDA     approved blood tests to assess brain ischemia in infants undergoing cardiac surgery.      Specific Aim 1: We will prospectively study 10 neonates (< 30 days of age) undergoing cardiac     surgery utilizing cardiopulmonary bypass for arterial switch operation or Norwood operation     to determine the specificity and sensitivity of a blood test for brain injury. This aim will     be accomplished by analyzing blood samples for S-100 and NSE drawn prior to surgery, once     each day following cardiac surgery as long as the patient remains in the intensive care unit     (maximum 5 days)and at the time of postoperative brain magnetic resonance imaging. The S-100B     and NSE values will then be correlated with brain magnetic resonance imaging studies before     cardiac surgery and at following cardiac surgery.      Hypothesis: We expect the concentration of S-100B and NSE will be significantly higher in the     blood of neonates with congenital heart disease who have documented brain injury on brain     magnetic resonance imaging (MRI). Furthermore, we predict that the blood levels of S-100B and     NSE may correlate to clinical outcome (time to extubation, hospital discharge,     neurodevelopmental outcome at 6 months of age).      Specific Aim 2: We will prospectively study these neonates at 6 months following cardiac     surgery to determine a correlation between neurodevelopment and concentration of S-100B and     NSE. To achieve this specific aim, a blood sample for S-100B and NSE and neurodevelopmental     testing will be done at 6 months following cardiac surgery.      Hypothesis: We expect neonates with elevated S-100B and NSE and abnormal brain magnetic     resonance imaging documented in specific aim 1 to have a significant decline in     neurodevelopment at 6 months after cardiac surgery.      Long-term: The long-term goal of this research is to diagnose brain ischemia in infants using     a biomarker blood test.   "
202400|NCT00490308|"     To evaluate whether treatment with Estradiol supplementation during the luteal phase improves     IVF outcomes      Patients undergoing IVF treatment with controlled ovarian hyperstimulation using a GnRH     analog will receive 4 mg estradiol valerate in the luteal phase.Patient's followup will     include E2 progesterone and BHCG 14 days after embryo transfer and vaginal ultrasound on day     21 and 28 after embryo transfer   "
202401|NCT00490321|"     The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing     long-term circulatory support for patients who have chronic stage D heart failure and are     ineligible for a heart transplant.      This is a multi-center, prospective, randomized, controlled clinical trial, which is     comprised of two independent modules.   "
202402|NCT00490334|"     This research involves assessment of cognitive outcome in childhood cancer as well as     evaluation of a cognitive rehabilitation program for improving learning and problem solving     difficulties in children with cancer.   "
202403|NCT00490347|"     The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD     in providing circulatory support for patients who require an LVAD as a bridge to cardiac     transplantation.   "
202404|NCT00490360|"     Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable     cancer of pancreatic head.   "
202405|NCT00490373|"     This study with pemetrexed is for patients with metastatic or unresectable pancreatic cancer     who progressed after first line chemotherapy with gemcitabine.   "
202406|NCT00490386|"     This study is performed to measure wether Helicobacter Pylori has an effect on the incidence     and course of acute alcohol induced pancreatitis   "
202407|NCT00490399|"     The purpose of this study is to evaluate the efficacy of gemcitabine and cisplatin in Korean     patients with biliary tract (bile tracts of the gallbladder or liver) cancer.   "
202408|NCT00490412|"     The purpose of this study is to test the effects of Vitamin D on renal phosphate and bone     loss, which are common in HIV infected adolescents and young adults being treated with     tenofovir.   "
202409|NCT00490425|"     Given that asthma results from a complex interaction between genetic susceptibility and     environmental factors and rates of childhood asthma are increasing, primary prevention has to     focus on modifiable aspects such as nutrition. There a implications from epidemiology that     food supplementation with probiotics given to atopic mothers in pregnancy and during     lactation can prevent the development allergies in the offspring. Children with atopic     dermatitis are at increased risk (up to 80%) of developing persistent respiratory tract     disease. Our trial examined whether probiotics are able to prevent allergic sensitization and     allergic asthma when given to 6-24 month old infants at an increased risk of allergies.   "
202410|NCT00490438|"     The patients will be submited to a vaginal squeeze pressure measurements before and after     surgeries for urinary incontinence.   "
202411|NCT00490451|"     The primary purpose of the study is to estimate the time from the first dose of LY573636 to     the date your physician determines that your disease has progressed or worsened.   "
202415|NCT00490503|"     The goal of this clinical research study is to learn if magnetic resonance imaging (MRI) with     magnetic resonance spectroscopy (MRS) can show the effects of pre-surgical chemotherapy in     breast cancer patients who are eligible to receive preoperative chemotherapy.   "
202416|NCT00490516|"     This is a randomized, double-blind, placebo-controlled parallel-group, 6-week study,     evaluating two dose levels of ACP-104 or Placebo twice a day in patients with schizophrenia     who are experiencing an acute psychotic episode.   "
202418|NCT00490542|"     Mixed states in bipolar disorder have long been recognized. Over a century ago, it was argued     that mixed states were the most common episodes in manic-depressive illness. A mixed state is     defined as a person who is experiencing symptoms of both depression and mania.      Currently, a person must have depression plus 3 or more manic symptoms for the episode to be     diagnosed mixed. Using this narrow view, less than 10% of episodes in patients with bipolar     disorder would meet criteria for a mixed episode. A broader view requires that the person     have at least 2 manic symptoms. Using this broader view, data suggest that about 50% of     episodes in bipolar disorder would be diagnosable as mixed states.      Studies suggest that the majority of persons with a depressive mixed state have bipolar     disorder type II. Many people who have a mixed state will also have major depression. Even     with such high potential rates of mixed episodes in both bipolar disorder and major     depression, there have been few studies addressing the issue.      The purpose of this study is to look at how effective Geodon is in treating the depressive     mixed state in people with bipolar or major depression. This will be the first clinical trial     that is both double-blind and randomized.   "
202419|NCT00490555|"     The investigators propose to examine the in vivo responses to hormonal manipulation at the     molecular level directly in the tissue of interest (prostate). As in the investigators'     previous, pilot study, the investigators will use the novel approach of procuring tissue     specimens from normal, healthy men who might be chose to use a male hormonal contraceptive     regimen were it available. The investigators will employ state of the art techniques such as     laser capture microdissection (LCM) and cDNA microarrays to determine the tissue-specific     consequences of male hormonal contraceptive regimens on the prostate. The results will help     guide the design, safety monitoring, and selection of male hormonal contraceptive agents and     provide valuable insights into prostate human prostate biology.      The investigators will test the hypothesis that exogenous T administration that results in     increased circulating T and dihydrotestosterone (DHT) levels will increase intraprostatic     concentrations of T and its metabolite DHT.      The investigators will test the hypothesis that the addition of a potent 5α-reductase     inhibitor, dutasteride, or the progestin, Depomedoxyprogesterone (IM DMPA), to T     administration in young and middle aged men will decrease intraprostatic DHT and increase     intraprostatic T concentrations compared to T alone.      The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor     dutasteride or the progestin IM DMPA to exogenous T, by reducing intraprostatic DHT, will     decrease prostate epithelial proliferation, assessed by Ki-67 labeling index (Ki-67LI), and     increase apoptosis, assessed by caspase-3 expression, and decrease androgen-regulated protein     expression such as prostate specific antigen (PSA).      The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor or     the progestin IM DMPA to exogenous T, by modifying the intraprostatic hormonal milieu, will     alter prostate epithelial gene expression. Specifically, the investigators expect that the     addition of the 5α-reductase inhibitor dutasteride or the progestin IM DMPA to exogenous T,     will result in decreased expression of androgen-regulated genes such as PSA.   "
202420|NCT00497094|"     Background. Carotid artery stenting (CAS) recently has become an accepted method for     treatment of patients with high-grade carotid artery stenosis, who are at an increased risk     for surgical carotid endarterectomy (CEA). The reported rates of neurological complications     of CAS substantially decreased during the past years, and the routine use of cerebral     protection devices and low profile catheter systems have further increased the procedure´s     safety. In the early 90's large surgical trials in North America and Europe (NASCET, ECST and     ACAS) demonstrated superiority of CEA compared to best medical treatment for symptomatic and     asymptomatic patients. Provided that the ongoing randomized controlled trials comparing CAS     and CEA confirm equivalence between the these methods, CAS similar to CEA is applicable to     symptomatic and asymptomatic patients with high grade carotid stenosis. However, particularly     in asymptomatic patients, the indication for revascularisation remains debatable. Protected     CAS is associated with a very low rate of neurological complications, which are below the AHA     recommendation for treating asymptomatic patients (3%). However, the introduction of new     vascular protective medications like statins and clopidogrel during the recent years     substantially improved the spectrum of best medical treatment, and the findings of NASCET,     ECST and ACAS with respect to best medical treatment may therefore not be applicable any     more.      Study hypothesis and aims. Given the low frequency of spontaneous neurological complications,     the preferable therapeutic approach to patients with asymptomatic high grade ( > 80%) carotid     artery stenoses is currently unknown. Modern best medical treatment may manage to stabilize     the atherosclerotic plaque, while CAS has the potential of resolving the carotid stenosis.     Comparative data, however, are not available as yet. We hypothesized that protected CAS has a     beneficial effect on occurrence of ipsilateral neurological complications and major adverse     cardiac events in high-risk patients with asymptomatic > 80% internal carotid artery     stenosis. Therefore, the aim of the present randomized controlled trial was to analyze     neurological and cardiovascular outcome of patients treated with elective CAS plus best     medical treatment compared to best medical treatment only.   "
202421|NCT00497107|"     The purpose of this study is to conduct a randomised controlled trial (RCT) comparing UFT/LV     and UFT/LV + PSK in patients with histological stage IIIa/IIIb colorectal cancer who have     undergone curative surgery without residual cancer using 3-year disease free survival (DFS)     as the primary endpoint, and also to analyze the 3-year overall survival (OS), compliance,     adverse events, quality of life (QOL) and relationship with tumor factors.   "
202422|NCT00497120|"     The aim of the study is to investigate wether the adjuvant (postoperative) administration of     acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients     with mild sleep apnea.   "
202423|NCT00497133|"     Glucagon-like peptide 1 is known to improve sensitivity of the pancreatic beta-cell. Further     it inhibit secretion from the pancreatic alpha-cell by mechanisms not fully understand. With     this study we wish to elucidate the potential of GLP-1 to increase the sensitivity of the     alpha-cell.      Type 2 diabetic patients and control subjects receive infusions of GLP-1 in increasing doses     or saline, alpha- and beta-cell responses are measured in blood-samples. During the study     plasma-glucose levels are clamped at fasting levels.      With this study we hope to elucidate the pathophysiology behind defect glucose tolerance in     type 2 diabetes mellitus and further more the potential of GLP-1 in treatment of type 2     diabetes mellitus.   "
202424|NCT00497146|"     To evaluate the effects of paricalcitol capsules on cardiac structure and function over 48     weeks in patients with Stage 3/4 chronic kidney disease (CKD) who had left ventricular     hypertrophy (LVH).   "
202425|NCT00497159|"     This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon     in improving cognitive, motor, and overall function in subjects with Huntington's Disease.   "
202426|NCT00497172|"     The main objective of this study is to assess the safety and effectiveness of the     Sirolimus-eluting stent CYPHERTM and/or updated version in reducing angiographic in-stent     late loss in de novo native coronary lesions of diabetic patients as compared to the bare     metal Bx SONIC balloon-expandable stent.      The secondary objective is to assess cost-effectiveness expressed in incremental cost/life     year gained or cost/quality adjusted life year gained at different time points (8 months, 1     year).   "
202427|NCT00497185|"     The aim of the study is to examine the efficacy of Mindfulness-Based Cognitive Therapy (MBCT)     in patients with functional disorders defined as severe Bodily Distress Disorder.      Hypothesis: MBCT can ameliorate the symptoms of FD defined as severe Bodily Distress Disorder     and decrease health care utilization beyond the effect of shared care. Patients treated with     MBCT will function better physically and socially than patients treated with shared care at     12 months' follow-up.   "
202428|NCT00497198|"     The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2     Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks     administration in double-blind, placebo-controlled manner. And in addition, the changes in     lipid-related parameters are examined.   "
202429|NCT00497211|"     Large acute myocardial infarctions are the most frequent cause of subsequent systolic heart     failure. Some evidence exists on the improvement after intracoronary administration of bone     marrow cells in patients with a recente acute myocardial infarction. Although subgroup     analyses suggest that patients with the largest myocardial infarctions have the largest     increase in ejection fraction after intracoronary bone marrow administration, there is no     published trial including only large myocardial infarctions. Therefor we sought to confirm     the subgroup analyses by conducting a trial in only large first acute myocardial infarction     patients.   "
202430|NCT00497224|"     This is an open-label, multi-center phase II study of erlotinib in patients with metastatic     or locally advanced, unresectable pancreatic cancer who have received up to one line of     gemcitabine based chemotherapy.   "
202431|NCT00497237|"     Asthma is a serious global health problem. People of all ages in countries throughout the     world are affected by this chronic airway disorder that can be severe and sometimes fatal.     The prevalence of asthma is increasing everywhere, especially among children.According to     international guidelines, once control of asthma is achieved and maintained for at least 3     months, a gradual reduction of the maintenance therapy should be tried in order to identify     the minimum therapy required to maintain control. This will help reduce the risk of side     effects and enhance patient adherence to the treatment plan.      Reduction of therapy in patients on combination therapy should begin with a reduction in the     dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients     with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped     down. Stepping-down will be attempted with two medications: a new combination of extrafine     beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and,     alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference     medication) without losing asthma control.If this hypothesis will be confirmed, the present     study will demonstrate that asthma control can be maintained with less than half the dose of     inhaled corticosteroid and with less medical costs.      Given the aims of this study, the population to be monitored includes adult patients with     moderate persistent asthma, which can be defined controlled according to the current     guidelines under standard stabilised treatment. The intended treatment duration is therefore     designed to ensure that good control of asthma is firmly achieved before stepping down the     treatment (8 weeks run-in period), but also that the condition of the patients are followed     long enough (24 weeks comparative treatment period) to ensure that a new stable condition is     also obtained and properly monitored.   "
202432|NCT00497250|"     The primary objective of this study is to evaluate the tolerability and the maximum tolerated     dose of Conformal or Intensity-Modulated Radiotherapy when given in combination with     gefitinib 250mg in Chinese patients with IIIB or IV NSCLC after failure of platinum-based     chemotherapy.      Secondary objectives of the study are to obtain the preliminary information on efficacy after     concomitant treatment of gefitinib 250mg and radiotherapy in Chinese patients with IIIB or IV     NSCLC after failure of platinum-based chemotherapy, as measured by RECIST criteria.      To determine the pattern of failure (e.g., local, regional, or distant metastasis) in     patients treated with this regimen.   "
202433|NCT00497263|"     the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device     in the creation of colorectal anastomosis   "
202434|NCT00497276|"     The most useful method to manage pain after major foot and ankle surgery is infusion of local     anesthetic with a catheter close to the sciatic nerve in the popliteal space above the knee     joint.      Inaccurate catheter placement and spread of local anesthetic account for most failures.      The most prevalent method to place the catheter is the traditional nerve stimulation     technique relying on surface anatomic landmarks and electrical stimulation to localize the     sciatic nerve. In recent years ultrasound technique has been applied to provide real-time,     visual guidance of catheter placement.      The purpose of this randomized, controlled trial is to compare the success rate, patient     acceptance and cost-effectiveness of the ultrasound and nerve stimulation techniques.   "
202435|NCT00497289|"     The study shall provide evidence for the save and efficient use of a fish oil containing     lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by     monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed     by monitoring of inflammatory parameters.   "
202436|NCT00497302|"     For the past several years our research program has developed and tested an intensive     outpatient intervention that is based in social learning theory and employs abstinence     contingent access to recovery housing as a routine aspect of an intensive day treatment     counseling program. The present project proposes to extend this treatment intervention to the     special population of pregnant drug using women enrolled at the Center for Addiction and     Pregnancy (CAP). We will compare an enhanced treatment that includes abstinence contingent     recovery house living plus intensive individual therapy, to standard care at the CAP program.     Specific aims of the project are derived from testing a two-group design are described below:        1. To determine whether financially supported abstinence-contingent recovery house          placement plus individual counseling in pregnant drug-dependent women improves prenatal          outpatient treatment retention.        2. To determine whether financially supported abstinence-contingent recovery house          placement plus individual counseling in pregnant drug-dependent women reduces prenatal          drug use.        3. To determine whether financially supported abstinence-contingent recovery house          placement plus individual counseling results in better maternal and infant clinical          birth outcomes (e.g., birth weight, estimated gestational age (EGA) at delivery, medical          complications).   "
202437|NCT00497315|"     The aim of this study is to evaluate if the multi modality treatment pemetrexed combined with     cisplatin and radiotherapy can lead to a better tumor control and/or a better side-effect     profile in patients with locally advanced NSCLC. Patients will be randomized between 3 cycles     of induction chemotherapy followed by concurrent chemoradiotherapy or concurrent     chemoradiotherapy followed by 3 cycles of adjuvant combination chemotherapy.   "
202450|NCT00499850|"     A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination     with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy     in patients with advanced colorectal adenocarcinoma.   "
202438|NCT00497328|"     This is a randomised controlled trial to investigate the efficacy of preventive regimen of     hydration with high dose oral N-acetylcysteine and intravenous sodium bicarbonate     pretreatment in patients with stable advanced renal insufficiency (CKD stage 3 and 4:GFR     15-60ml/min/1.73m2 calculated by Modification of Diet in Renal Disease Study equation (MDRD     formula)) undergoing elective percutaneous coronary intervention (PCI).   "
202469|NCT00500097|"     The purpose is to assess accuracy of digital retinal image interpretation by technicians and     direct ophthalmoscopy by nurses for the determination of diabetic retinopathy severity and     the presence of diabetic macular edema for the identification of referrals to     ophthalmologists. The results of both screening methods were compared with comprehensive eye     examination by ophthalmologists.   "
202439|NCT00497341|"     Knee prosthesis infection is a severe complication. The use of a tourniquet during surgery     impairs the efficacy of the antibiotic prophylaxis. We hypothesize that the antibiotic     administration before tourniquet release decrease the infection rate. Methods: patients who     undergo a total knee arthroplasty will be randomized to receive one of the following regimens     of antibiotic prophylaxis:Standard: cefuroxime 1.5 g i.v. 10 min before tourniquet + placebo     10 min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical     wound.Experimental: cefuroxime 1.5 g i.v. 10 min before tourniquet + cefuroxime 1.5 g i.v. 10     min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.   "
202440|NCT00497354|"     Peripheral nerve blocks provide many advantages for patients (excellent pain control and     reduction in nausea) undergoing upper and lower limb surgery however several commonly     occurring complications can produce annoying but sometimes serious adverse effects. The     interscalene brachial plexus block (ISBPB) is one such technique, commonly performed for     shoulder surgery, but also produces paralysis of the diaphragm, Horner's syndrome and     sometimes vocal cord paralysis with standard volumes of local anesthetic. This threat of     these side effects limits the use of ISBPB in many patients who would particularly benefit     e.g. patients with lung disease. Recently the use of ultrasound guidance is allowing     practitioners to place smaller volumes of local anesthetic with much greater accuracy. This     can potentially avoid anesthetizing important adjacent nerves to the target structure. If     ultrasound-guided techniques with smaller volumes of local anesthetic could be demonstrated     to reduce the incidence of complications without reducing effectiveness this would be very     beneficial for patients.This will be the first randomized, double blind study to evaluate if     an ultrasound-guided ISBPB with low volumes of local anesthetic can reduce complications for     patients whilst maintaining quality of anesthesia and pain relief in the intra-operative and     postoperative period.   "
202441|NCT00497367|"     The purpose of this study is to determine the safety and feasibility of use in humans of the     TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System in the treatment of de novo     lesions in native coronary arteries involving a major side branch. The TAXUS® Petal™ is an     investigational device with an indication of improving coronary artery luminal diameter while     maintaining side branch access in subjects with symptomatic ischemic disease due to discrete     atherosclerotic bifurcation lesions   "
202442|NCT00497380|"     Muscle catabolism is a major problem in cancer patients undergoing surgery as it negatively     affects post-operative recovery. Recent evidence exists that protein metabolic changes are     already apparent in cancer before muscle wasting is being present. In line, patients with     breast cancer, generally characterized by a normal nutritional status, were recently found to     be arginine deficient. Arginine deficiency in cancer can be explained by: 1) Reduced arginine     availability, due to exhaustion of endogenous (muscle) sources of arginine 2) Enhanced     arginine catabolism, due to conversion of arginine by arginase, which is abundant in tumors.     Protein is the most important endogenous source of arginine. Arginine deficiency will lead to     a negative feedback loop in cachexia by promoting protein breakdown in an attempt to restore     plasma arginine levels. We hypothesize that pre-operative arginine supplementation in breast     cancer patients diminishes the occurrence of muscle wasting after surgery by 1) normalizing     arginine availability pre-operatively, resulting in conservation of protein, 2) diminishing     the catabolic effects of surgery by supplying exogenous arginine for the post-operative     response, 3) enhancing the anabolic capacity to feeding through supplying substrate for     protein synthesis.   "
202443|NCT00497393|"     This randomized controlled trial will introduce a Clinical Decision Unit (CDU) into the     University of Alberta Hospital Emergency Department(ED)and assess the influence on ED length     of stay, patients who leave without being seen, and other ED Overcrowding outcomes.   "
202444|NCT00497406|"     A study for head and neck cancer patients to evaluate the feasibility of combining salivary     gland transfer surgical procedure and IMRT helical tomotherapy to reduce dryness of mouth.   "
202445|NCT00497419|"     Reperfusion delay in STEMI has been shown to be excessive in our community. In order to     improve delay a fast track (direct transfer in catheterization laboratory) has been     implemented. The present study aims at evaluating the benefits of this procedure.   "
202446|NCT00499798|"     RATIONALE: Learning whether temozolomide changes semen or sperm in patients with brain tumors     may help doctors learn about the long-term effects of treatment and plan the best treatment.      PURPOSE: This clinical trial is studying changes in semen or sperm caused by temozolomide in     patients with newly diagnosed, progressive, or recurrent primary malignant brain tumors.   "
202447|NCT00499811|"     This phase I trial is studying the side effects and best dose of vorinostat in treating     patients with metastatic or unresectable solid tumors or lymphoma and liver dysfunction.     (closed for accrual as of 04/05/2010) Vorinostat may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Vorinostat may have different effects in     patients who have changes in their liver function.   "
202448|NCT00499824|"     To test whether the International Diabetes Federation - Western Pacific Region (IDF-WPR)     Guidelines are more effective than standard practices in primary care (general practitioner)     clinics for the management of type 2 diabetes mellitus (T2DM) in Asia. A 12-month     multinational multicentre prospective cluster randomisation clinical trial within a primary     care setting, with 2 parallel treatment arms: diabetes management using IDF-WPR guidelines     versus standard clinic practices. 400 subjects will be recruited from 100 sites (4 subjects     per site) in ten Asian countries (China, Hong Kong, Indonesia, Korea, Malaysia, Philippines,     Singapore, Taiwan, Thailand and Vietnam).   "
202449|NCT00499837|"     Cystic Fibrosis (CF) is an inherited disorder in which mucus-secreting glands in the lungs     produce considerable quantity of thick, sticky secretions that clog the airways, promote     bacterial growth and lead to chronic obstruction, inflammation and destruction of the     airways.      The purpose of this study is to collect data about the resolution of the chronic inflammatory     state in addition to assure the safety of the therapy in CF patients.   "
202555|NCT00501228|"     Primary Objective:      1. To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells     contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue     caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell     transplantation.      Secondary Objective:      1. To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to     epithelial/endothelial or solid organ-specific tissue.   "
202453|NCT00499889|"     Primary Objective:      To estimate the probability of molecular complete remission at one year for the described     sequential treatment approach, with nonablative hematopoietic transplantation, post     transplant imatinib mesylate and donor lymphocyte infusion, in patients with Ph-positive     Chronic Myelogenous Leukemia (CML) not in blastic transformation.      Secondary Objective:      Response to post transplant Imatinib mesylate therapy for 12 weeks as treatment of residual     disease, response to donor lymphocyte infusion (DLI) for residual disease following imatinib     mesylate therapy, as well as engraftment, toxicity, disease free survival and survival,     effect of busulfan pharmacokinetics on study outcome.   "
202454|NCT00499902|"     The purpose of this study is to identify a safe and effective bolus dose of     intra-arterial/intra-thrombus alfimeprase in acute ischemic stroke (AIS) 3 to 9 hours from     symptom onset.   "
202455|NCT00499915|"     Premature infants have a significantly increased risk for developing respiratory illnesses     and asthma. Secondhand smoke (SHS) also is clearly associated with increased breathing     problems in children, thus exposure to smoke makes it substantially more likely for a     premature infant to develop wheezing. The overall goal of this study is to test whether     comprehensive asthma education combined with a home-based secondhand smoke reduction program     can reduce exposure to smoke and prevent respiratory illness among premature infants. Our     hypotheses are:        -  More premature infants whose families receive asthma education combined with a SHS          reduction intervention will live in smoke-free environments compared to infants          receiving only asthma education (control group).        -  Caregivers receiving the SHS reduction program will have higher rates of quit attempts          and less relapse into smoking compared to caregivers in the control group.        -  Infants whose families receive the combined intervention will experience less          respiratory illness compared to infants in the control group.   "
202456|NCT00499928|"     This study will examine the biological fate of radioactive SB-751689 administered to healthy     males and healthy postmenopausal women. Subjects will receive a single oral dose of     radioactive SB-751689. Excreta and blood samples will be taken over the course of 7 days.     This study will help determine the major route of elimination of SB-751689 in humans. It will     also provide samples (blood, plasma, urine, and stools) for analysis of metabolites, if any.   "
202457|NCT00499941|"     The Alpha-1 Foundation Research Registry is a confidential database made up of individuals     diagnosed with severe alpha-1 antitrypsin deficiency (Alpha-1) or the carrier state.   "
202458|NCT00499954|"     This is a mono-centre trial performed at the Center for Clinical Research at the Medical     University Graz. There will be a screening information and a study visit.In the study visit     arterialized venous blood glucose values will be monitored and subcutaneous sampling of     interstitial fluid (ISF) with microdialysis for glucose determination will be performed.     Additionally to the laboratory analysis of the subcutaneous glucose samples, the glucose will     be measured with extracorporeal on-line sensors and two marketed devices (Guardian RT and     Glucoday S).The study visit will last 30 hours starting with the insertion of microdialysis     catheters in the abdominal subcutaneous tissue and the insertion of the catheters for the     Glucoday S system and Guardian RT system. The primary hypothesis of the study is:     Interstitial fluid glucose concentration profiles correlate to the arterialized venous blood     glucose concentration profile in type 1 diabetic subjects.   "
202459|NCT00499967|"     The purpose of this study is to assess the safety, tolerability and activity of GS-9191     ointment in the treatment of genital warts. GS-9191 ointment is intended for topical     application directly to genital warts on the skin.   "
202460|NCT00499980|"     The purpose of this study is to evaluate a dynamic near infrared imaging device for     characterizing suspicious breast lesions   "
202461|NCT00499993|"     The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the     control of Growth Hormone (GH) secretion in patients with active acromegaly.   "
202462|NCT00500006|"     This study will evaluate MK0457 in combination with Dasatinib in patients with Chronic     Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.     Efficacy and Safety will be evaluated.   "
202463|NCT00500019|"     Hypothesis: The bacterial flora of the uterus during elective Cesarean sections differs from     the uterine flora during non-elective Cesarean sections. We want to study whether the uterine     flora can predict post-cesarean febrile morbidity and endometritis.   "
202464|NCT00500032|"     Subjects who have completed study 6108A1-500, in which our experimental meningoccal B vaccine     or placebo was administered, will be approached for inclusion into this study which is purely     for blood draw. The sera will be used for assay development.   "
202465|NCT00500045|"     The aim of this study is to develop a less risky, yet effective and more sustainable     treatment for retinal vein occlusions than the current commonly used approach of repeated     intravitreal triamcinolone acetonide (Kenalog) injections. The types of retinal vien     occlusion that are being studied include central (CVRO), hemi-retinal (HRVO),and branch     (BRVO) retinal vein occlusion. Niacin, (Nicotinic Acid, not Nicotinamide) a B-vitamin, has     lipid lowering and vasodilating properties. The combination of Niacin and Prednisolone     Acetate steroid eye drops as a non-invasive treatment approach was developed by the Principal     Investigator. The Niacin dilates the retinal vessels, hopefully encouraging earlier     collateral vessel formation aimed at bypassing the venous obstruction, thus restoring venous     outflow. The Prednisolone Acetate steroid eye drops are aimed at reducing vascular leakage     and therefore the macular edema in the eye while the Niacin is taking effect.   "
202466|NCT00500058|"     The purpose is to identify a dose of SB-485232 which is safe, tolerable and effective when     used in combination with Rituximab in patients with non-Hodgkin's lymphoma (NHL). This study     will use a standard treatment regimen of Rituximab in combination with rising doses of     SB-485232. The dose selected from this study will be used in a future studies.   "
202467|NCT00500071|"     Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with     ADHD are dosed to optimal effect.   "
202468|NCT00500084|"     This is an open-label, single-arm clinical study investigating the long-term safety of     ALTU-135 treatment in Chronic Pancreatitis (CP) patients with exocrine Pancreatic     Insufficiency (PI).   "
202584|NCT00501618|"     The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo     (orally disintegrating tablet). Generic clozapine is the most frequently used clozapine and     such data is important for clinicians to have.   "
202470|NCT00500110|"     Primary Objective:      1. To evaluate the pathological complete response rate to neoadjuvant hormonal ablation,     Imatinib and Docetaxel (HID) in high-risk localized prostate cancer.      Secondary Objectives:        1. To describe the time to prostate specific antigen (PSA)-progression after neoadjuvant          HID and radical prostatectomy in high-risk localized prostate cancer.        2. To correlate pathological response with modulation of the Platelet-Derived Growth Factor          Receptor (PDGFR) pathway.   "
202471|NCT00500123|"     The Alpha-1 Coded Testing (ACT) Study was established to study genetic testing and outcomes     of individuals at risk for alpha-1 antitrypsin deficiency.   "
202472|NCT00500136|"     This study was designed to examine if provoking thoughts of mortality among medical students     can influence cardiac risk assessments depending on the religion of the target patient.   "
202473|NCT00500149|"     The primary objective of this study is to assess the time of onset of Vyvanse compared to     placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and     Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with     Attention-Deficit/Hyperactivity Disorder (ADHD).   "
202474|NCT00500162|"     Melasma is an acquired, symmetric, irregular hypermelanosis on sun-exposed areas of the face,     commonly seen in Latin American women. It is a very frequent disease, although its true     incidence is unknown.      Melasma has historically been difficult to treat and therapy remains a challenge for this     chronic condition.      Melasma being a relapsing disease, there is a real need to address how to maintain efficacy     achieved after acute treatment. A previous 12-month trial has shown that Tri-Luma® applied     once daily over a long-term period is safe and tolerable. However, there are no robust data     available either on the efficacy of Tri-Luma® in long-term treatment or guidance for a     maintenance dosage regimen with this product.      Investigations have been made through a feasibility work among Dermatologists from USA and     Latin America to assess their current practice in terms of Maintenance Therapy. Two regimens     appear to be prescribed frequently and will be compared in this study.      The expectation is that Tri-Luma® will be effective, in one of the two regimens explored, in     maintaining the Melasma improvement achieved with a previous treatment of Tri-Luma®.   "
202475|NCT00500175|"     More than half of all lower extremity amputations are in persons with diabetes. These     patients suffer from severe, diabetes-induced, peripheral, sensory neuropathy and, thus they     frequently do not protect their feet from repetitive shear stress or traumatic episodes and     ulceration often ensues. We have previously shown that the temperature profile of the plantar     aspects of the foot provides a reliable warning of tissue injury and can be effectively used     as a preventive modality. In this study we propose to further develop and clinically test a     novel infrared-based temperature instrument (TempTouchRM®) that is intended for home use by     high-risk diabetic patients. This step-on remote monitoring device will serve as an early     warning system for impending ulcers and Charcot fractures. The study’s central hypothesis is     that the TempTouchRM device will reduce the incidence of ulcers by providing an accurate,     simple, and effective approach to monitor changes in foot temperatures.   "
202476|NCT00500188|"     Primary objectives        1. To determine whether induction of apoptosis or inhibition of angiogenesis are involved          in the antitumor activity of (Gleevec, Formerly STI-571) in patients with          gastrointestinal stromal tumors (GIST) as assessed by Positron Emission Tomography (PET)          scanning.        2. To determine whether dynamic computed tomography (CT), PET scan, molecular and          histopathologic responses in GIST tumors from patients treated with Gleevec predict          Disease-Free Survival (DFS) time.      Secondary objectives        1. To determine the disease free survival of patients with resectable or partially          resectable gastrointestinal stromal tumors treated with Gleevec preoperatively and          continued for 2 years after resection of disease.        2. To assess the safety and tolerability of Gleevec given to patients with GI stromal          tumors 3, 5, or 7 days preoperatively and continued postoperatively.   "
202477|NCT00500201|"     Study to compare PK of a new 120mg tablet with two 60mg tablets. This is required because we     plan to have only single tablets administered in the later phase clinical trials but we have     not had a 120mg strength before. As this is a new previously untested strength we need to     ensure that the PK is similar to that achieved using 2x60mg before we start a large     manufacturing campaign and before we administer to a large number of patients. The study is     planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of     18 subjects. There will be 20 days washout between each dose. Initially 4 subjects will be     given a single oral dose of 120 mg SB-773812 and 2 will be given placebo. If 120mg SB-773812     is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed. If     the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be     stopped. Subjects will return to the centre for follow-up 14 to 21 days after the final     dose.It is expected that the total duration of the study should be approximately 11 weeks.   "
202478|NCT00500214|"     this study was designed to evaluate the effect of routine excision of the ilioinguinal nerve     in an attempt to decrease the incidence of chronic inguinodynia in patients who undergo open     anterior hernia mesh repair.   "
202479|NCT00500227|"     The objective of this study is to evaluate, in acromegalic patients with disease persistence     after surgery who are treated with somatostatin analogues, the histopathological, clinical,     morphological and biochemical factors which are predictive of hormonal control.   "
202480|NCT00500240|"     The goal of this clinical research study is to learn if intense management and control of     blood sugar levels during treatment for acute lymphocytic leukemia, Burkitts lymphoma, or     lymphoblastic lymphoma will result in decreased risk of relapse, fewer complications, and/or     longer survival.   "
202585|NCT00501631|"     VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to     abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.     This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus     placebo. Injections were administered to patients in whom abstinence was enforced by a period     of inpatient hospitalization of 7 to 21 days.   "
202556|NCT00501241|"     The purpose of this study is to determine whether ATI-7505 is effective in the treatment of     chronic idiopathic constipation.   "
202557|NCT00501254|"     Evaluation of the pharmacodynamic profile (antiaggregant profile, balance of prostanoids and     nitric oxid) of a ASA-SR (slow-release)formulation in comparison with a ASA NR (normal     release), 150 mg, during 12 months of treatment.   "
202481|NCT00500253|"     The aim of this study is to assess the utility of exhaled nitric oxide measurement (FeNO) in     treatment monitoring in children with asthma.      According to the aim of the study following assumptions are formulated:        1. Comparison of annual cumulative steroid dose, number of bronchodilator doses taken,          number of asthma exacerbation, number of hospitalisation due to asthma, between group of          children with asthma with FeNO monitored treatment (study group), and group of children          with treatment monitored by GINA's grade of disease clinical control (control group)        2. Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function          (FEV1)        3. Comparison of values of non-specific bronchial hyperresponsiveness with methacholine          (PC20M)between both study groups after 12. months of treatment.   "
202482|NCT00500266|"     To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly     subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide     vaccine (23vPS) at least 3 years before study enrollment.   "
202483|NCT00500279|"     To evaluate the effect of celecoxib use for 3 month after drug-eluting stent implantation        -  on restenosis        -  on clinical outcome such as target lesion revascularization, thrombotic event,          myocardial infarction, death        -  on inflammatory biomarkers   "
202484|NCT00500292|"     The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in     combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients     who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.   "
202485|NCT00500305|"     A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants.     Standard indomethacin treatment is associated with intestinal and renal morbidity. B-type     natriuretic peptide is elevated in significant PDAs. This study will determine whether BNP     guided therapy could reduce doses of indomethacin.   "
202486|NCT00500318|"     This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in     reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It     was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind     treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria     were randomized to one of two treatment groups: aclidinium bromide or placebo.   "
202487|NCT00500331|"     This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a     range of doses of investigational product and pioglitazone, compared to placebo, administered     as monotherapy over 12 weeks in treatment naive patients with T2DM   "
202488|NCT00500344|"     CNV from AMD is the leading cause of blindness in people over 50 in North America. The     hypothesis is to determine if there is an improvement in retinal function determined by ERG     following treatment with ranibizumab for AMD   "
202489|NCT00500357|"     This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further     evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate     vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC,     and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This     study will determine if a subsequent dose of 13vPnC one year later results in similar or     greater immune response (body's ability to protect against disease) than that measured after     the initial dose of 13vPnC.   "
202490|NCT00500370|"     This is a multicenter study designed to compare the effect of exenatide plus a lifestyle     modification plan versus placebo plus a lifestyle modification plan on weight loss in     non-diabetic, obese subjects.   "
202491|NCT00500383|"     This study aims to evaluate if a light based technique, called Optical Breast Spectroscopy     (OBS) formerly known as Transillumination Breast Spectroscopy (TiBS), can be used to detect     differences in breast tissue between high- and low-risk populations and within the high-risk     population between BrCa1 or 2 carriers and non-carriers. These differences may include     differences in breast tissue composition and metabolism at time of enrollment into the study     (possibly reflecting changes occurring in adolescence) and in the rate of breast tissue     change over time (possibly reflecting rate of tissue transformation from normal to ultimately     malignant state).   "
202492|NCT00500396|"     Vascular Endothelial Growth Factor (VEGF) is a dimeric glycoprotein, naturally expressed in     epithelial and tumor cells (1). Normal Retinal vascularization has two phases: In the first     fase, cells of mesenquimatous origin form the first superficial plexus (14-21 weeks of     gestation). In the second phase, denominated angiogenesis phase, the superficial and deep     capillary plexus are formed (15,20). The Retinopathy of Prematurity (ROP) was described for     the first time in 1942 (4), at the present moment it is a public health problem in the     developing countries. The International Classification of ROP classifies it in 5 stages,     dividing it in 3 anatomical zones. It is a public health problem that continuous without     having an effective prophylaxis. The early diagnosis and treatment in thresholds stages have     changed the prognosis of this disease (11,12).   "
202493|NCT00500409|"     OSTEOFORM, containing recombinant (rhPTH [1-34]), enhances bone mineral density and reduces     risk for vertebral fracture. This study evaluates the safety and efficacy of OSTEOFORM in the     treatment of osteoporosis in post-menopausal women.   "
202494|NCT00500422|"     The goal of this clinical research study is to find the highest safe dose of the drug Velcade     (bortezomib) that can be given together with gemcitabine and pegylated liposomal doxorubicin     (Doxil) in the treatment of advanced cancer. The effect of this combination treatment on     tumor growth will also be studied.   "
202495|NCT00500435|"     Primary Objectives:        -  To determine the feasibility of performing an extraperitoneal laparoscopic          lymphadenectomy in patients with stage IB2-IVA cervical carcinoma who are dispositioned          to undergo radiotherapy and concurrent chemotherapy.        -  To document intraoperative and postoperative complications in patients undergoing          extraperitoneal laparoscopic lymphadenectomy.        -  To determine the rate of lymph node metastases in the para-aortic region in patients          with stage IB2-IVA cervical cancer.        -  To correlate histopathological findings in the para-aortic lymph nodes with preoperative          imaging studies (Positron emission tomography (PET) and magnetic resonance imaging (MRI)          and computed tomography (CT)).   "
202722|NCT00502359|"     Present practice: Measurement of fasting glucose values in 2nd trimester of pregnancy, if     above 4.8 mmol/l, a Glucose Tolerance Test is performed. (Two-step procedure: 1. Appointment     for the fasting glucose measurement, 2. Appointment for the Glucose Tolerance Test)   "
202496|NCT00500448|"     Patients with knee osteoarthritis (OA) often have decreased thigh muscle strength. This     muscle weakness is thought to originate from centers in the brain and spinal cord that     restrict recruitment of fibers responsible for muscle contraction. An inability to fully     contract muscles surrounding the knee joint impairs patients' abilities to perform activities     of daily living (i.e. walking, climbing stairs) and may even contribute to further joint     degeneration.      Establishing therapies aimed at increasing muscle strength, restoring normal function, and     possibly slowing the processes involved in the development of knee OA is essential in order     to enhance the quality of life in the adult population plagued with this degenerative joint     condition.      Electrical muscle stimulation applied to the thigh is a promising therapy that has been shown     to successfully restore muscle strength, however how long the treatment lasts and its     influence on functional outcomes remains unknown. In order for electrical muscle stimulation     to be of value it must result in sustained improvements in muscle strength and functional     outcomes. Therefore, the purpose of the proposed investigation is to determine if electrical     muscle stimulation can restore thigh muscle strength and improve functional outcomes in     patients with knee osteoarthritis.   "
202497|NCT00500461|"     GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This     will be an open-label, dose-ascending study in 7 healthy male subjects to establish well     tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is     to confirm an IV and oral dose for a definitive human radiolabel metabolic study.   "
202498|NCT00500474|"     Meniere's disease is a common inner ear disease with an incidence of 15-50 per 100,000     population. Since Meniere’s disease is thought to be triggered by an immune insult to inner     ear, we examined intra-endolymphatic sac application of large doses of steroids as de novo     treatment for intractable Meniere’s disease.   "
202499|NCT00500487|"     Adolescents are at risk for HIV because of sexual and drug behavior intiated during this     developmental period. Those with psychological distress are less likely than their peers to     benefit from frequently used skills-based interventions. It appears that emotional lability     during sexual situations disrupts skills learned. This project will implement and evaluate     interventions for adolescents with psychiatric disorders who are in therapeutic school     settings. Affect management and skills-based interventions will be compared to a didactic     standard of care condition to determine which intervention best reduces risk behavior among     adolescents with psychiatric disorders in therapeutic school settings.   "
202500|NCT00500500|"     The aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the     isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate     Alzheimer's disease.   "
202501|NCT00500513|"     Objectives:        -  To determine the safety of fiducial implantation.        -  To determine the extent/rate of migration of radio-opaque fiducials placed in lung          tumors and adjacent normal tissue.        -  To compare real-time portal imaging-based fiducial tracking with measurement of          three-dimensional motion by four-dimensional CT scanning to determine how many fiducials          are needed to track a tumor.        -  To determine if intra-fractional lung tumor motion changes during a course of treatment,          and when during the treatment this occurs.        -  To correlate the position of internal fiducials with the position of the external          patient surface during respiration.        -  To quantify the residual motion of the clinical target volume during radiotherapy gated          using external fiducials.        -  To verify the adequacy of the treatment portal margins in encompassing the residual          motion of the clinical target volume.        -  To determine if radio-opaque fiducial placement adjacent to the trachea (which does not          move) can reduce daily setup inaccuracies, and so spare normal tissue.        -  To determine the motion of hilar adenopathy (if any), and whether it correlates with          motion of the primary tumor.   "
202502|NCT00500526|"     The purpose of this study is to investigate the effects of the practice of singing for a long     period of time on pulmonary function data, quality of life, and dyspnea sensation of patients     with COPD in stable clinical conditions. As singing is a type of respiratory training, the     study hypothesis is that singing would improve maximal respiratory pressures, dyspnea     sensation, and overall quality of life of these patients.   "
202503|NCT00500539|"     The primary objective of this study is to assess the immunogenic potential of the liquid     formulation of omalizumab administered over a period of 6 months in moderate to severe     persistent allergic asthma patients 12 years of age or older, with no previous exposure to     the drug (omalizumab naïve patients). The secondary objective of this study is to assess the     safety of the liquid formulation of omalizumab in the same patients.   "
202504|NCT00500552|"     Hypertrophic Cardiomyopathy (HCM) is a relatively common inherited heart muscle disease. Many     patients experience symptoms of breathlessness, fatigue and chest pain. These symptoms are     not always controlled with current therapies.      Recently the investigators showed that a drug called Perhexiline markedly improved exercise     capacity and symptoms in patients with heart failure. In this proposal the investigators wish     to test whether Perhexiline improves exercise capacity and relieves symptoms in patients with     HCM   "
202505|NCT00500565|"     The objective of this pilot study is to examine the efficacy of the ON~Q Pain Relief System     plus Intravenous Patient Controlled Analgesia (IVPCA) with Morphine vs IV PCA alone in     patients undergoing free transverse rectus abdominis musculocutaneous (TRAM) flap surgery.     The primary outcome measure will be postoperative opioid analgesia requirements. Other     outcomes will also be assessed, including pain scores, quality of recovery, and resource     utilization.   "
202506|NCT00500578|"     Primary Objectives:        1. To determine whether aerosolized ribavirin is effective when given at an intermittent          dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection          (URI) and whether it can prevent progression to pneumonia.        2. To determine the effect of this regimen on persistence of viral shedding.   "
202540|NCT00501033|"     Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging     obstetrical process, and may be influenced or complicated by the cervical ripening method     used. We will conduct a comparative study of the foley catheter vs the cervical ripening     double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean     section rate, infections and postpartum complications, especially endometritis.   "
202558|NCT00501267|"     The purpose of this study is to determine the effect of repeat doses of solabegron and     oxybutynin when taken alone or together   "
202507|NCT00500591|"     It is known that women who are obese are at higher risk of endometrial cancer (cancer of the     lining of the uterus or womb). The goal of this clinical research study is to find out how     common abnormalities of the endometrium are in women who are considered obese and to find out     if those same abnormalities are less common in women who are considered to be thin.     Researchers would like to learn if obese patients have symptoms (like irregular menstrual     cycles) that may mean there could be an abnormality present. Researchers would also like to     know if obese women have access to regular female exams and whether they routinely go to     their primary care doctors.   "
202508|NCT00500604|"     The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg     against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP)     as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.      The secondary objectives are:        -  To compare the percentage of patients with normal blood pressure as measured by HBPM and          at the doctor's office at weeks 16 and 24        -  To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and          evening SBP and DBP evaluated by HBPM at weeks 16 and 24        -  To compare the difference in mean SBP evaluated by HBPM at week 16        -  To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks          16 and 24        -  To determine the incidence and severity of adverse events   "
202509|NCT00500617|"     Atherosclerotic coronary artery disease (CAD) is the most common cause of morbidity and     mortality worldwide. CAD is precipitated by a complex interaction of genetic and     environmental factors. Establishing the diagnosis of CAD before a myocardial infarction or     death is critically important. However, the diagnosis of CAD can be a significant challenge,     and current non-invasive modalities often yield indeterminate results.      There are several biologically based theories of atherogenesis related to plaque development     in arterial walls. The aim of this study is to identify genetic and biological markers that     distinguish patients with CAD.   "
202510|NCT00500630|"     The goal of this study was to clinically validate a new device for the objective outcome     evaluation of adult patients undergoing shoulder surgery for glenohumeral osteoarthritis and     rotator cuff disease, using the activities of daily living described in the Simple Shoulder     Test (SST) as a reference.      The study was set up as a clinical trial including patients over an observation period of one     year and a control group of subjects. Clinical evaluations will be made at baseline, 3     months, 6 months and 1 year after surgery by two independent observers. Miniature sensors     each containing three 3D gyroscopes and three 3D accelerometers will allow computing new     kinematic scores. They will be compared to the regular SST, DASH, ASES and Constant scores.   "
202511|NCT00500656|"     Primary Outcome Measures:      The primary endpoint was the time to onset of symptom relief of the first attack in the     double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic     acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid     refers to the hazard rate under tranexamic acid.      Secondary Outcome Measures:        -  Additional efficacy assessments (Time to Almost Complete Symptom Relief)        -  Safety and tolerability        -  Pharmacoeconomics   "
202512|NCT00500669|"     To investigate whether Betadine can reduce infection rates and recurrence rates following     varicose veins surgery in a randomized double blind placebo controlled study.   "
202513|NCT00500682|"     1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to     standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first     occurrence of any event of the triple composite outcome of initiation of dialysis, kidney     transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate     the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate     the effects of AST-120 versus placebo, on other measures of renal function.   "
202514|NCT00500695|"     This project will assess the utility of a brief motivational intervention to engage smokers     with schizophrenia in treatment for tobacco dependence treatment. It is hypothesized that a     brief motivational intervention will be more effective in engaging smokers with schizophrenia     to tobacco dependence treatment than an educational intervention. The educational     intervention will increase the likelihood to reducing cigarette intake and/or attending     tobacco dependence treatment by teaching subjects about the negative effects of smoking and     the success of tobacco dependence treatment. The motivational intervention will increase the     likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by     increasing subjects' motivation to change by presenting objective and personalized     information regarding their smoking behaviors in a non-judgmental and supportive manner.   "
202515|NCT00500708|"     Heart failure (HF) affects 5 million Americans, with 500,000 new cases diagnosed and 250,000     deaths each year. The two major causes of morbidity and mortality in HF are pump failure and     sudden, lethal ventricular arrhythmias, the latter of which accounts for 40-50% of HF deaths.     Arrhythmias may be precipitated by a complex interaction of genetic and environmental     factors. Establishing increased risk for arrhythmias before a severe life-threatening event     is critically important. However, this remains a significant medical challenge.      Several genetic mutations associated with rare, inherited arrhythmia disorders have been     identified. The aim of this study is to identify novel genetic and other biological markers     that distinguish patients at increased risk for lethal ventricular arrhythmias in a broader     population.   "
202516|NCT00500721|"     To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of HCV-796     and a single dose of desipramine when coadministered to healthy subjects.   "
202517|NCT00500734|"     The goal of this laboratory research study is to collect and store blood and tissue from     patients who have a diagnosis of heart disease and may be at a high risk for the development     of heart failure. This blood may be used in the future to identify genes that may play a role     in developing congestive heart failure (CHF) from chemotherapy or other sources.   "
202541|NCT00501046|"     1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to     standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first     occurrence of any event of the triple composite outcome of initiation of dialysis, kidney     transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate     the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate     the effects of AST-120 versus placebo, on other measures of renal function and quality of     life.   "
202518|NCT00500747|"     The purposes of this study are to evaluate the safety, tolerability, and effectiveness of a     vaccine (the HCV E1/E2/MF59 vaccine) against hepatitis C (HCV). The vaccine will be given to     60 healthy adult volunteers (aged 18-45 years) and the study will compare the immune system     (the body's protective response) response to the HCV E1/E2 vaccine given at different dosage     levels: 4 micrograms, 20 micrograms, or 100 micrograms in MF59 adjuvant (substance that can     improve vaccine effectiveness). The volunteers will be assigned randomly (by chance) to 1 of     4 different groups. Volunteers in each group will receive a shot of the vaccine or a placebo     (shot with no medication). Participants will be involved in study related procedures for up     to 71 weeks, which includes blood samples, recording symptoms on a diary card, and 4 vaccine     or placebo injections.   "
202519|NCT00500760|"     The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for     patients with locally advanced squamous cell carcinoma of the head and neck but additional     improvements to treatment regimens are needed. The study is investigating if the addition of     a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding     unmanageable toxicity.   "
202520|NCT00500773|"     The purpose of this study is to determine the cardiovascular risk involved in the exertional     exercise of marathon running. The researchers aim to investigate the beneficial effects of     regular well-dosed exercise on health and compare these findings with the effects of the     extreme strains of marathon running. Subclinical injuries to heart and arteries are being     investigated in different groups of runners, including obese participants.   "
202521|NCT00500786|"     This is a multi-center, randomized, placebo-controlled, time-lagged, parallel-group study in     healthy and hypertensive subjects to evaluate safety and tolerability of the vaccine     CYT006-AngQb. The trial is double-blind for active vs. placebo within each treatment arm, but     open with respect to AngQb dose escalation.      In the first arm, 16 healthy normotensive volunteers are treated with a one dose regimen     consisting of a single s.c. injection of 100µg of AngQb or placebo. Upon satisfying safety     and tolerability profile, as judged by the independent safety monitoring board, arm two is     enrolled.      In arm two 36 patients with mild to moderate hypertension receive three s.c. injections of     100µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections     are given 4 and 12 weeks after the first injection, respectively. Upon satisfying safety and     tolerability profile, as judged by the independent safety monitoring board, arm three is     enrolled.      In arm three 36 patients with mild to moderate hypertension receive three s.c. injections of     300µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections     are given 4 and 12 weeks after the first injection, respectively.      The primary objective of the trial is to evaluate safety / tolerability of 3 dose regimens of     CYT006-AngQb in healthy volunteers and patients with mild to moderate essential hypertension.     Secondary objectives include the assessment of pharmacodynamic effects and their     dose-response (immunogenicity and biomarkers of the renin-angiotensin system), and the     exploration of clinical efficacy (effects on systolic and diastolic blood pressure)   "
202522|NCT00500799|"     This study will examine the role of certain areas of the brain in blepharospasm, a type of     dystonia (abnormality of movement and muscle tone) that causes unwanted or uncontrollable     blinking or closing of the eyelids. The study will compare brain activity in healthy     volunteers and in people with blepharospasm to find differences in the brain that may lead to     better treatments for dystonia.      Healthy volunteers and people with blepharospasm who are 18 years of age and older may be     eligible for this study. All candidates are screened with a medical history. People with     blepharospasm also have a physical examination and blepharospasm rating.      Participants undergo transcranial magnetic stimulation (TMS) and electromyography (EMG) in     two 4-hour sessions, separated by 1 to 7 days.      TMS      A wire coil is held on the subject's scalp. A brief electrical current is passed through the     coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may     feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the     face, arm or leg. During the stimulation, subjects may be asked to tense certain muscles     slightly or perform other simple actions. Repetitive TMS involves repeated magnetic pulses     delivered in short bursts of impulses. Subjects receive 60 pulses per minute over 15 minutes.      EMG      Surface EMG is done during TMS to measure the electrical activity of muscles. For this test,     electrodes (small metal disks) are filled with a conductive gel and taped to the skin of the     face....   "
202523|NCT00500812|"     This trial is a multi-center, open-label, dose-escalation study designed to evaluate the     safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury     patients: those with a complete cervical injury or a complete thoracic injury. Dose levels     from 0.3 mg - 9 mg of Cethrin will be administered.   "
202524|NCT00500825|"     The purpose of this study is the evaluation of the influence of therapeutic hypothermia on     resting energy expenditure (REE) in patients after cardiopulmonary resuscitation (CPR). We     hypothesized that hypothermia would reduce resting energy expenditure in these patients.   "
202525|NCT00500838|"     The intent of this feasibility study is to collect and analyze intra-thoracic impedance     measurements from a CRT-D device in a heart failure population.   "
202526|NCT00500851|"     The purpose of this study is the evaluation of the success rate of jejunal tube placement     comparing the endoscopic versus the electromagnetic method in a comparative ICU patient     population. The investigators hypothesized that success rate of the electromagnetic jejunal     tube placement will be lower than the success rate of the endoscopic method.   "
202527|NCT00500864|"     Dietary magnesium (Mg) intake has been shown to be independently related to lung function,     airway reactivity, and respiratory symptoms in the general population. Inhaled Mg and IV Mg     administration have been shown to promote bronchodilation and to improve lung function in     asthmatic patients. Some studies have suggested that COPD patients exhibit decreased body     levels of Mg. The purpose of the present study was to investigate the effects of acute IV Mg     loading on parameters of respiratory function and maximal exercise capacity of stable COPD     patients.The study hypothesis is that Mg administration will be associated to improvements on     airflow and vasodilation leading to improvements of pulmonary function and exercise     performance.   "
202528|NCT00500877|"     Information obtained from this study will help us to have a better idea of how phone     counseling may facilitate the process of quitting smoking for individuals with a history of     recurrent depression.   "
202529|NCT00500890|"     The goal of this clinical research study is to compare carboplatin to cyclophosphamide when     given with etoposide, vincristine, and radiation therapy in the treatment of choroid plexus     tumors. The safety of these 2 combination therapies will also be compared.      Objectives:      OVERALL AIM:      To improve choroid plexus tumor treatment through better understanding of the tumor biology     and through increased knowledge about the benefit of specific treatment elements.      Specific Objectives:      The study will have a prephase to evaluate the feasibility of the following randomized study     (main phase).      Pre-Phase (completed 2005) Primary Specific Objective:      To determine the number of patients accountable per year for randomization in a worldwide     study.      Secondary Specific Objective:      To measure the number of drop outs and to describe the toxicity of the chemotherapy.      Main Phase (started in 2006) Primary Specific Objective:      To compare the survival times after cyclophosphamide based treatment with the survival times     after carboplatin based treatment in choroid plexus tumor patients.      Main Phase Secondary Specific Objectives:        1. To compare the resectability of choroid plexus tumors after two blocks of          cyclophosphamide based treatment with the resectability after two blocks of carboplatin          based treatment.        2. To compare response rates of incompletely resected choroid plexus tumors to two blocks          of cyclophosphamide based treatment with the response rates after two blocks of          carboplatin based treatment.        3. To determine the prognostic relevance of histological atypia and SV40 in choroid plexus          tumors.   "
202530|NCT00500903|"     To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of MLN8237     when given by mouth (PO) for a minimum of 7 and a maximum of 21 consecutive days, followed by     a 14-day recovery period.   "
202531|NCT00500916|"     The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff     to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The     manufacturer recommends inserting the PLMA using digital manipulation, like the Classic LMA,     or with an introducer tool (IT), like the Intubating LMA. The mean (range) frequency of     insertion success at the first attempt for these techniques is 84% (81-100) and 95% (90-100)     respectively, with the main causes of insertion difficulty being impaction at the back of the     mouth and failure of the distal cuff to reach the hypopharynx. Howarth et al described an     insertion technique which overcomes these difficulties by using a gum elastic bougie (GEB)     placed in the esophagus to guide the PLMA around the back of the mouth and into its correct     position in the hypopharynx. Howarth et al reported no failed uses from 100 consecutive     insertions. In the following study, we test the hypothesis that GEB-guided insertion is more     frequently successful than the digital and IT techniques in patients with difficult airway.   "
202532|NCT00500929|"     To provide information on parameters needed to design a subsequent Phase III confirmatory     trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk     geriatric patients undergoing open-heart surgical procedures (OHSP) requiring     cardio-pulmonary bypass.   "
202533|NCT00500942|"     Primary Objectives:        -  To measure and record patients' pain levels before, during, and after standard          procedures performed in IR.        -  To compare different procedures to respective pain levels and patient satisfaction (as          determined by questionnaire).   "
202534|NCT00500955|"     Following a 4-week single-blind placebo run-in period, eligible subjects were randomized in a     1:1 ratio to receive 32 weeks of double-blind study medication: Rosiglitazone (starting dose     4mg od) or Glyburide (starting dose 5mg od), both in combination with open-label Metformin >     or = (1g/day). Subjects were stratified for use of ACEI, nondihydropyridine calcium channel     blockers (NDP CCB), or angiotensin II receptor blockers (ARB) to provide equal representation     of these subjects in each treatment group.   "
202535|NCT00500968|"     Randomized study assessing the effect of transpapillary pancreas duct stent in resection of     the pancreatic tail.   "
202536|NCT00500981|"     The goal of this study is to evaluate whether measures of the size of the internal jugular     vein have clinical utility in predicting whether patients may benefit from treatment with     intravenous fluid.   "
202537|NCT00500994|"     This study is part of a series of studies that will explore how the mind and the brain work     to cause episodes of uncontrollable shaking in people who have no known underlying brain or     medical disorder. The study is conducted at NIH and at the Brown University Rhode Island     Hospital.      Healthy volunteers and people with psychogenic movement disorders (PMD) or non-epileptic     seizures (NES) who are 18 years of age or older may be eligible for this study.      Patients with NES have 3 teaspoons of blood drawn. The blood is tested for two genes that are     normally found in healthy individuals to see if they are found more frequently in patients     with uncontrolled shaking.      Patients with PMD have blood drawn for testing and also undergo functional magnetic resonance     imaging (fMRI) to look at how the brain functions while the subject performs a specific task.     MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues.     During the scan, the subject lies on a table that can slide in and out of the scanner, a     metal cylinder. The scan lasts about 60 to 90 minutes, during which the subject may be asked     to lie still for up to 10 minutes at a time and to perform tasks, such as identifying the     gender of faces shown on a screen.      Healthy volunteers may have blood drawn for genetic testing or fMRI or both.   "
202538|NCT00501007|"     The primary purpose of this investigation is to determine the predictive value of task     persistence as measured by a mirror tracing task. A secondary purpose is to evaluate     differences in task persistence in smokers with or without schizophrenia. It is hypothesized     that task persistence in smokers in both diagnostic categories (schizophrenia and no     schizophrenia) will predict tobacco dependence treatment outcome at one and six months. It is     also hypothesized that smokers with schizophrenia will show lower levels of task persistence     after controlling for other motor skills than smokers without schizophrenia.   "
202539|NCT00501020|"     This was a randomized, double-blind, double dummy, multicenter study to assess the safety,     efficacy and tolerability of the addition of RSG (rosiglitazone) to sub-maximal MET     (metformin) combination relative to maximal MET monotherapy in subjects with type 2 DM     (diabetes mellitus). The total duration of the study was approximately 20 months. The study     consisted of a two-week washout period, a four to seven-week MET titration period, and a     24-week randomized treatment phase in which subjects, stratified by prior therapy, received     either RSG + MET combination therapy or MET monotherapy.   "
202542|NCT00501059|"     The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been     extensively studied. However, the overall risk level of the study populations was low (< 10%     10-year CHD risk). The current study is designed to prove the efficacy and tolerability of     100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease     (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal     stroke and CV death, in a population with no history of known CVD who are at moderate risk of     major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient     population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard     care setting and may receive treatment for the underlying risk factors as defined by the     treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee     and the study will be monitored by an independent Data Safety Monitoring Board.   "
202543|NCT00501072|"     To investigate the effectiveness and safety of a Real Time Continuous Glucose Monitoring     System (RT-CGMS in a population of patients with type 1 diabetes mellitus treated with     insulin through an implanted pump.   "
202544|NCT00501085|"     The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.   "
202545|NCT00501098|"     -  To assess the overall clinical yield - in terms of efficacy and safety endpoints of          adding caspofungin as prophylaxis of Invasive Pulmonary Aspergillosis in patients          undergoing induction treatment for newly diagnosed acute leukemia        -  To investigate the prognostic significance of Ptx3 at diagnosis and during the first          chemotherapy cycle with respect to the development of IPA   "
202546|NCT00501111|"     The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with     mild or moderate Alzheimer's disease, to assess the safety and tolerability of ZAD3480 and to     define the optimal dose(s) to be used in future trials.   "
202547|NCT00501124|"     A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period.     Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks     followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this     study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine     alone in patients with chronic hepatitis B infection.   "
202548|NCT00501137|"     Primary objective is to determine if antibody responses to HPV types 16 & 18 are non-inferior     after a 2-dose paediatric regimen as compared to a 3-dose adult regimen of Q-HPV vaccination,     with responses measured at Month 7.   "
202549|NCT00501150|"     The main purpose of this study is to find out whether changing the hospital policy to allow     switch from glycopeptide antibiotics (given by intravenous drip), to an equally effective     oral antibiotic (linezolid) will enable patients who are otherwise well enough to be     discharged from hospital sooner.      The secondary objectives are        1. To identify those patients who could potentially be discharged on an oral agent from          those being treated with a glycopeptide, thus helping target this approach most          effectively        2. To evaluate the cost involved and compare this with the costs that would have taken          place if use of an oral agent and discharge had not occurred.   "
202550|NCT00501163|"     Participants will be asked to do the following:        1. A screening session in which you will take part in a diagnostic interview that will take          about 2-3 hours to complete and will address your medical history. If you've recently          participated in one of Dr. Haupt's or Dr. Newcomer's studies (HRPO #03-1281, 01-0134, or          04-0191) you may not have to complete this screening interview.        2. An ultrasound test of your heart and blood vessels where an ultrasound machine will use          sound waves to create images that allow the main blood vessels in your neck to be          examined. You will be lying down for the procedure, and a colorless gel will be applied          to the side of your neck where the handheld probe (called a transducer) will be placed.          The transducer will then be gently moved over each side of your neck. This procedure          will take approximately 30 minutes.        3. A magnetic resonance image (MRI) study where the amount of fat in your liver will be          measured. The MRI involves having your body painlessly scanned inside a tubular machine,          while lying on a table for about 45 minutes.        4. Some routine blood tests to assess glucose (sugar) and lipid (fat) control and liver          function, as well as an additional hepatitis screen if you have a history of hepatitis.          You will go to the Intensive Research Unit (IRU) or Clinical Trials Unit (CTU) after an          8 to 10-hour overnight fast (except water). Approximately 42 ml (3 tablespoons) of blood          will be obtained from you, and you will also have your height, weight, blood pressure,          and waist and hip measurements taken. This will take approximately one hour.        5. A dual energy x-ray absorptiometry (DEXA) scan to measure your body fat and body muscle          content. The DEXA scan involves lying on a table in a private room wearing a hospital          gown for about 15 minutes while a machine silently measures the amount of fat in your          body. The DEXA scan is part of the research study and gives the researcher a picture of          how much fat is in your body.   "
202551|NCT00501176|"     Randomized study comparing the effect of plastic stents to that of expandable metal stents as     pre-operative drainage of the bile ducts prior to Whipple operation.   "
202552|NCT00501189|"     This project will compare the rate of regression of minimally abnormal Pap smears to normal     in women who receive Gardasil to a historical control group.      Research hypothesis: Women with low grade cervical dysplasia on Papanicolaou (Pap) smear that     receive Gardasil vaccination will revert to a normal within one year at a rate 33% higher     than historical controls that did not receive Gardasil vaccination.   "
202553|NCT00501202|"     The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200     mg of RWJ-333369 given twice daily by mouth compared with placebo in the treatment of     Diabetic Peripheral Neuropathy (DPN).   "
202554|NCT00501215|"     Primary hyperparathyroidism (PHPT) is an endocrine disorder that disrupts calcium metabolism     and has a broad range of clinical manifestations. With respect to the nonclassic, subjective     symptoms that have been reported to be associated with PHPT, such as sleep disturbance,     neurocognitive dysfunction, mood disturbance, fatigue, and decreased quality of life, there     is a lack of objective data on the extent to which these symptoms are affected by     parathyroidectomy.      There have been reports of improvements in sleep in patients following parathyroidectomy, but     these have been based solely on subjective sleep surveys. To date, there are no published     studies on objective sleep evaluations of patients with PHPT. The overall goals of this     protocol are to ascertain the feasibility of performing sleep studies on patients with PHPT,     and to obtain pilot data on the effects of parathyroidectomy on those sleep studies.      It is hypothesized that it will be feasible to evaluate sleep parameters in patients with     PHPT in the M. D. Anderson Sleep Center. Towards testing this hypothesis, the specific aims     are:      Specific Aim 1: To assess the feasibility of using nocturnal polysomnography (PSG) to     evaluate the primary outcome measure of total sleep time.      Specific Aim 2: To assess the feasibility of using nocturnal polysomnography (PSG) to     evaluate the secondary outcome measures of sleep architecture, arousal index, sleep     efficiency, wake after sleep onset, and sleep onset latency in patients with PHPT.      Specific Aim 3: To assess the feasibility of evaluating the secondary outcome measures of     subjective sleepiness as tested with the Epworth Sleepiness Scale (ESS), and of sleep quality     as tested with the Brief Sleep Disturbance Scale (BSDS) in patients with PHPT.      Specific Aim 4: To assess the feasibility using a randomized wait-list-control design to     assess the effects of parathyroidectomy on sleep measures obtained with nocturnal PSG.   "
202617|NCT00502047|"     The hypothesis of this study is that soluble fibre may contribute to a reduction of the low     density lipoprotein cholesterol (LDL-c), and the combined effect with a statin may achieve an     optimisation of the cholesterol-lowering effects in adults with several cardiovascular risk     factors.   "
202559|NCT00501280|"     Primary Objectives:        1. To test the hypothesis that children whose mothers are Migrant/Seasonal Farmworkers          (MSFs) (occupationally-exposed to pesticides) may be at a higher risk for exhibiting          mutagen-induced DNA damage than children whose mothers and fathers are not MSFs.        2. To test the hypothesis that MSF mothers (occupationally-exposed to pesticides) may be at          a higher risk for exhibiting mutagen-induced DNA damage than mothers who are not MSFs.      Secondary Objectives:        1. To test the hypothesis that both the extent of pesticide exposure and the type of          polymorphisms in chemical detoxification genes and DNA repair genes contribute to the          extent of cytogenetic damage found in children of MSF women.        2. To test the hypothesis that both the extent of pesticide exposure and the type of          polymorphisms in chemical detoxification genes and DNA repair genes contribute to the          extent of cytogenetic damage found in MSF mothers.        3. To test the hypothesis that the total concentration levels of organochlorine (OCP) and          organophosphate (OP) pesticides will correlate with the mutagenic potency of the serum          and urine of the children.        4. To test the hypothesis that the total concentration levels of OCP and OP pesticides will          correlate with the mutagenic potency of the serum and urine of the mothers.        5. To test the hypothesis that inherited polymorphisms in the PON1 gene and its expression          modulate the risk for OP genotoxicity measured by the inhibition of the          acetylcholinesterase enzyme in MSF children.        6. To test the hypothesis that inherited polymorphisms in the PON1 gene and its expression          modulate the risk for OP genotoxicity measured by the inhibition of the          acetylcholinesterase enzyme in MSF mothers.   "
202560|NCT00501293|"     To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17     years diagnosed withADHD   "
202561|NCT00501306|"     This study is designed to identify barriers that prevent men who have sex with men from     receiving doctor-recommended annual follow-up screenings for anal cancer. Men who are at the     highest risk for developing anal cancer will be asked to complete a brief questionnaire     (either via telephone or in writing). The questionnaire is designed to identify potential     barriers to care-seeking behavior including, relationship status, financial constraints,     highest level of education and knowledge about anal cancer and its precursors. The men who     agree to participate in the study will then be organized into groups based on their history     of coming in for follow-up screening visits after learning that they are at higher risk for     developing anal cancer. These groups include 1) men that have come in for regular screening     visits (at least once per year), 2) men who came in once and were then lost to follow-up, 3)     men who came in for more than one screening visit and were then lost to follow-up, and 4) men     who were previously lost to follow-up and then began coming in for screening again. By     comparing the men's responses across the different groups, we hope to uncover key barriers     and drivers to follow-up screenings for anal cancer.      The goal of this study is to evaluate the differences in questionnaire responses across     cohorts that may impact care-seeking behavior.      We hypothesize that:        -  Patients who regularly comply with annual follow-up screening visits score higher on          questions assessing knowledge of HPV and anal cancer.        -  Men in stable relationships are more likely to comply with annual screening visit          recommendations.        -  Men who are educated by their primary care physicians about the importance of anal          cancer screenings have higher screening rates.   "
202562|NCT00501319|"     Primary Objectives:        -  To longitudinally assess the natural history of symptoms (prevalence, severity, patterns          of symptoms, and the relationship of physical and psychological distress) among          post-thoracic surgery for non-small cell lung cancer patients with early stage (stage          I-IIIA) disease.        -  To determine crisis events (when symptoms are most severe), their relationship with          cancer therapy, surgical techniques and disease, and their relationship with function          and quality of life; and to determine current practice patterns of symptom control          throughout the six months of the post-surgical phase.        -  To determine the utility of a weekly, telephone-administered interactive voice response          symptom assessment (IVR-MDASI) for identifying emergent clinically significant symptoms          in this population.        -  To develop symptom severity critical values and critical treatment algorithms for          post-operative symptom control for NSCLC patients.   "
202563|NCT00501332|"     This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients     treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle     of chemotherapy, for a planned total of six chemotherapy cycles.   "
202564|NCT00501345|"     Primary Objective:      To determine the risk of bleeding from ASA therapy in thrombocytopenic patients who develop     Acute Coronary Syndrome (ACS), and assess its effect on the overall morbidity and mortality     in these patients as well as platelet functions.   "
202582|NCT00501592|"     The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus     (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:        -  The safety and tolerability of multiple doses of INT 747;        -  The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and          glucose homeostasis;        -  Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes          and biochemical markers of hepatic and metabolic function and inflammation, and;        -  Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic          acid (6-EDCA) and tauro 6-ECDCA.   "
202565|NCT00501358|"     There is some evidence for a hypercoagulable state in sleep apnea-hipopnea syndrome (SAHS),     which could play a role in the increased cardiovascular morbility and mortality. Respiratory     alterations (hypoxia, hypoxia- reoxygenation) and sleep fragmentation that these patients     suffer during the sleep may induce modifications in clotting-fibrinolisis factors that may be     a risk factor for venous thromboembolism (VTE).      OBJECTIVES:To calculate and compare the prevalence of sleep apnea-hipopnea syndrome in     patients with venous thromboembolism with a gender, aged and BMI matched control group.     Assessment of the association between SAHS and other risk factors for VTE. To compare     clotting- fibrinolisis patterns, sleep parameters, blood pressure and pulmonary arterial     obstruction index in patients with SAHS and VTE and those ones without SAHS.   "
202566|NCT00501371|"     Phase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS     (30mg/day) vs. placebo.      Subproject MCS-2: alpha-blocker naïve subjects      Subproject MCS-3: subjects responding poorly to alpha-blocker   "
202567|NCT00501384|"     The primary objective is to determine the optimal dose or range of doses of SR121463B for the     reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of     spironolactone.      The secondary objective was to determine the tolerability of different fixed doses of     SR121463B in cirrhotic ascites, over a 12-week treatment period.      This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety     extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).   "
202568|NCT00501397|"     The purpose of this research study is to evaluate the effect of several daily doses of     ketoconazole (a medication used to treat fungal infections like athlete's foot) on a single     dose of GSK189075 (an experimental diabetes drug), and also to evaluate the safety and     tolerability of GSK189075 in healthy volunteers. The study will see whether ketoconazole     causes GSK189075 to stay in your bloodstream for a longer period of time. It will also     examine whether GSK189075 causes any changes in the amount of glucose you have in your urine.   "
202569|NCT00501410|"     The goal of the Phase I part of this clinical research study is to find the highest tolerable     dose of a combination of dasatinib, cetuximab, and FOLFOX (5-fluorouracil [5-FU], leucovorin     [LV], and Eloxatin [oxaliplatin]) that can be given to patients with metastatic colorectal     cancer. The safety of these drugs in combination will also be studied.      The goal of the Phase II part of this clinical research study is to learn if dasatinib given     in combination with FOLFOX with or without cetuximab can help to control metastatic     colorectal cancer.   "
202570|NCT00501423|"     The ADRIE study is an observational study on the clinical relevance of platelet reactivity in     aspirin and clopidogrel treated cardiovascular patients.   "
202571|NCT00501449|"     The specific aims of the study include:        1. Profile the demographic, health-related, psychosocial and behavioral characteristics of          adults with MEN1 or MEN2.        2. Evaluate MEN-specific distress as well as adherence to surveillance regimens among          adults with MEN1 or MEN2, and identify associated with those outcomes.   "
202572|NCT00501462|"     This is an open-label study that will measure blood levels of different parts of a drug     called GKS189075. People participating in this study will receive a single dose of 250mg     GSK189075 by mouth. About 20 people with mild to moderate decrease in renal (kidney) function     will be asked to participate in this study. They will be compared to about 20 healthy     participants who are close to the same age and body size. People participating in this study     will stay at a clinical research unit beginning 2 days before they receive their single dose     of GSK189075 and will remain there until approximately one day after receiving the study     drug. During this study urine will be collected beginning the day before receiving study drug     until the day after, just prior to leaving the clinical research unit. Blood samples will     also be collected at various times beginning immediately before until 24 hours after     receiving the study drug.   "
202573|NCT00501475|"     The purpose of this study is to evaluate the effect of NAC or sodium bicarbonate in     preventing the aggravation of renal function in chronic renal failure when enhanced computed     tomography scan is checked in emergency room.   "
202574|NCT00501488|"     The aims of the present study were to investigate the association between adiponectin gene     polymorphisms and the response to rosiglitazone monotherapy in T2D patients.      A total of 255 T2D patients and 120 health volunteers were enrolled in this study. 42 T2D     patients with -11377(C/G) or +45(T/G) genotypes were selected to administrate orally 4mg     rosiglitazone daily for 12 consecutive weeks.   "
202575|NCT00501501|"     Hypothesis: The rates of rehospitalization after cesarean section are significantly higher     than those following spontaneous vaginal delivery and are due mainly to late bleeding and     less to infection.   "
202576|NCT00501514|"     The purpose of this study was to assess whether Growth Hormone(GH)improves exercise capacity     and cardiopulmonary performance in patients with chronic heart failure.   "
202577|NCT00501527|"     The objective of this trial is to evaluate the clinical effectiveness of the administration     of a depigmented and polymerized allergen extract of Phleum pratense in the     rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass     pollen.   "
202578|NCT00501540|"     The purpose of this study is to learn more about the effectiveness and side effects of     lithium treatment for subjects with low-grade neuroendocrine tumors.   "
202579|NCT00501553|"     To investigate the prevalence of vitamin D deficiency in patients with Heart Failure.      To investigate if vitamin D levels are correlated to the degree of Heart Failure.   "
202580|NCT00501566|"     The primary objective is to determine the optimal dose or range of doses of SR121463B for the     treatment of ascites when used concomitantly with a standard dose regimen of spironolactone     and furosemide.      The secondary objective is to determine the tolerability of different fixed doses of     SR121463B over a 14 day treatment period in cirrhotic ascites.   "
202581|NCT00501579|"     The purpose of this study is to determine the safety and efficacy of difluprednate compared     with prednisolone acetate in the treatment of endogenous anterior uveitis.   "
202583|NCT00501605|"     Single centre recruiting approximately 80 patients who are given a rising single, followed by     multiple, ascending oral dose of AZD2171, assessing the safety and tolerability of AZD2171 in     patients with solid tumors and metastatic liver disease.   "
202618|NCT00502060|"     Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer   "
202586|NCT00501644|"     Primary Objectives:        1. Determine response rate, time to progression, and toxicity of a schedule of carboplatin          by IV (intravenous) infusion, GM-CSF and rIFN-g by SC (subcutaneous injection) in          patients with potentially platinum-sensitive recurrent Müllerian carcinomas.        2. Determine whether this treatment schedule is associated with:             1. increased levels of monocytes (>2-fold and absolute numbers 1000 cells/ml,) and of               LN-DR+ DC (CD11c+ and CD123+ subsets)             2. induction of priming and activation of MO/MA (monocytes/ macrophages), and               maturation of DC (dendritic cells).        3. Determine the toxicity profile of consolidation treatment with IP (intraperitoneal)          injections of rIFN-g added to carboplatin (IV) and GM-CSF (SC) for 4 doses/course.        4. Determine the effects of carboplatin plus GM-CSF and rIFN-g on quality of life in          patients with platinum-sensitive Müllerian carcinomas.        5. To begin an exploration of cell surface proteins on purified activated peripheral blood          and ascites monocyte/macrophages both before and after treatment with GM-CSFand rIFN-g.   "
202587|NCT00501657|"     The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate     at which the stomach empties, and the release of gut hormones and blood glucose     concentrations, after a mashed potato meal in healthy subjects. Sitagliptin has been shown to     reduce the blood glucose (sugar) response to a meal and this may potentially be due to     slowing of stomach emptying. This is particularly relevant to people who have diabetes, in     whom normalization of elevated blood glucose levels is important to maintain health.   "
202588|NCT00501670|"     This study will evaluate and compare various methods for collecting lesion samples from     subjects with clinically diagnosed herpes zoster for the laboratory confirmation of herpes     zoster. The samples will be tested by polymerase chain reaction (PCR) to detect VZV DNA.     Multiple samples from each type of herpes zoster lesion will be collected in order to     determine whether the analysis of duplicate samples enhances the sensitivity of VZV DNA     detection for the diagnosis of herpes zoster. In addition, blood will be collected for the     evaluation of VZV immunity at the time of the initial herpes zoster sample collection (after     herpes zoster has been clinically diagnosed) and one month later in order to establish the     range of cellular and humoral immune responses during natural herpes zoster in adults ≥50     years old.   "
202589|NCT00501683|"     This study will look at the relative amounts of GSK189075 that are found in samples of blood,     urine, and feces of healthy male volunteers. Results of the study will be used to understand     how the drug is converted in the body and how it is eliminated.   "
202590|NCT00501696|"     This is a randomized placebo-controlled, parallel-group study, crossover-design of the     effects of low dose naltrexone on the multiple sclerosis quality of life inventory (MSQLI54)      This study will assess the impact of LDN compared to placebo on quality of life as measured     by the composite score of the MSQOL54 in adult subjects with MS.      Also we plan:        1. To compare the 10 scales of the MSQOL54 during the active treatment and placebo cycles          between active treatment and placebo groups        2. To compare each individual's composite response to LDN versus placebo during the active          treatment and placebo cycles        3. To compare each individual on the 10 scales of the MSQOL54 during the active treatment          and placebo cycles   "
202591|NCT00501709|"     Pancreatic islets are the part of the pancreas that produce insulin and help control the     blood sugar. This study aims to improve islet transplantation as a treatment for Type 1     Diabetes by using a new combination of immunosuppressive drugs that have been successful in     treating other autoimmune diseases and in preventing kidney transplant rejection.   "
202592|NCT00501722|"     The primary objective is to determine the optimal dose or range of doses of SR121463B for the     treatment of ascites and the correction of hyponatraemia when used concomitantly with a     standard dose regimen of spironolactone.      The secondary objective is to determine the tolerability of different fixed doses of     SR121463B over a 14 day treatment period in cirrhotic ascites.      This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term     safety extension (Expo~CAT). The first extension is followed by another long-term study     (PASCCAL-1).   "
202593|NCT00501735|"     This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up     to 50 sites in North America, Europe and Australia. This study is designed to assess     objective response (OR) [complete response (CR) or partial response (PR)] in subjects with     cutaneous manifestations of CTCL with a requirement for maintenance of such objective     response for at least 28 days in subjects with stage IIB, III, and IVA CTCL. Additionally,     this study will evaluate the safety and tolerability of CTCL subjects Stages IB, IIA, IIB,     III, or IVA treated with oral forodesine.   "
202594|NCT00501748|"     The goal of this research study is to investigate whether Rituximab is safe to use in     patients suffering from NMO, or who are at high risk for developing NMO. It is thought that     NMO is caused by the immune system reacting against the optic nerves and spinal cord. B cells     are a part of the immune system that may contribute to the illness. Rituximab is an antibody     that depletes B cells. Depletion of these B cells with Rituximab may induce remission of the     disease. Because pathological and serological studies suggest that NMO appears to be, at     least in part, a B-cell mediated disease Rituximab, is an attractive treatment candidate for     this disease.   "
202605|NCT00501891|"     This is a phase II study of the combination of Avastin and metronomic temozolomide in     recurrent malignant glioma patients. The primary objective will be to determine the efficacy     of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The     secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in     combination with metronomic temozolomide in terms of progression-free survival.   "
202615|NCT00502021|"     Preliminary studies have shown that flaxseed powder, rich in the omega-3 alpha-linolenic     acid,is beneficial for the general inflammation present in morbidly obese subjects by     decreasing elevated serum markers.As omega-3 fatty acids display additional properties     including possible amelioration of atherosclerosis,a 3-month supplementation protocol was     devised.Arterial stiffness and intima thickness will be measured in severely obese subjects,     in order to document possible reduction of these variables as well.   "
202616|NCT00502034|"     The aim of this study is to compare the efficacy (in terms of event-free survival and overall     survival) of an adjuvant therapy with IFN-alpha plus low-dose of IL2 vs a wait-and-see     program in patient with radically operated renal cell carcinoma.   "
202606|NCT00501904|"     Metformin, an oral biguanide administrated for treating type-2 diabetes mellitus, is a safe     and effective drug recently experimented also in patients with polycystic ovary syndrome     (PCOS). The administration of metformin induces ovulatory cycles in CC-resistant or     -nonresistant patients with PCOS, and improves the ovulation rate as an additional treatment     in women who received CC.      To date, it is unknown the best protocol for metformin administration. In particular, it is     not known how long patients who ovulate under metformin should continue treatment before     switching to second-line ovulation induction therapy. In this regard, in a recent study by     the Kaplan-Meier survival analysis we demonstrated that the first pregnancy occurred late     after metformin with an estimated median of seven months.      Based on these considerations, the aim of the present study will be to evaluate the clinical     efficacy of metformin according to its duration of administration in infertile PCOS patients     ovulating under treatment.   "
202595|NCT00501761|"     Researchers propose to apply Social Cognitive Theory to improve understanding of the     mechanisms of physical activity adherence for endometrial cancer survivors participating in a     physical activity intervention.      The specific aims of the study are:        1. To test a Social Cognitive Theory-based model of physical activity adoption among          sedentary endometrial cancer survivors receiving an intervention to increase physical          activity. The model includes hypotheses about the effect of self-efficacy and outcome          expectations on physical activity adherence, the effects of four sources of efficacy          information (mastery experience, verbal persuasion, modeling, and physiological          feedback) on self-efficacy and subsequent exercise adherence, and the influence of          physical activity outcomes on subsequent self-efficacy, outcome expectations, and          physical activity.        2. To elucidate the influence on self-efficacy of cardiorespiratory fitness and somatic          sensations while engaging in physical activity.        3. To determine whether the received dose of an intervention based on Social Cognitive          Theory is related to physical activity adherence.        4. To test the effects of adherence to physical activity on endometrial cancer survivors'          quality of life and stress as assessed by self-report and salivary cortisol.        5. To test the feasibility of a web-based maintenance intervention for women who have          completed the phone counseling portion of the study.   "
202596|NCT00501774|"     Hypothesis: to examine a possible association between localized vulvodynia and H. pylori     infection.   "
202597|NCT00501787|"     In a recent prospective study evaluating the efficacy of 1700 mg/day metformin as first-line     approach for infertile anovulatory patients with PCOS, we identified predictors for metformin     efficacy. Our analysis demonstrated that body mass index (BMI) and insulin resistance were     the strongest predictors for both ovulation and pregnancy. In particular, adjusting the data     for insulin resistance, a trend in reduced effectiveness was observed with increasing BMI. On     the other hand, adjusting the data for BMI, a trend in improved efficacy was detected for     higher insulin resistance degrees.      To date, no dose-finding study is currently available in literature evaluating the best dose     of metformin to administer. In addition, very few data regarding the best protocol for     metformin treatment also are available. However, in order to reduce drug-related side effects     incidence due to start-up syndrome, metformin is generally administrated with meals at     incremental weekly doses until the maximum dosage ranging from 500 to 2550 mg daily; the     doses are reduced if side effects appear. This commonly accepted protocol has not been     supported by scientific evidences.      The aim of the present study will be to evaluate in a clinical setting the compliance, the     safety and the effectiveness of two schedules for metformin administration in infertile     anovulatory PCOS patients.   "
202598|NCT00501800|"     The purpose of this study is to identify clinical and genetic markers of ovarian aging. In     this process, we will evaluate environmental factors that may affect fertility and the age at     which fertility declines, and may influence the age at which women enter menopause. Wide     variability exists between women both in the age at which menopause occurs and the rate of     decline in oocyte number and reproductive capability. As the loss of ovarian function has     profound impact on women's hormonal milieu and their subsequent risk for the development of     disease, improving our understanding of the factors that determine the timing and rate of     reproductive aging is critical to improving quality of life for all women. In addition,     improving our understanding of reproductive aging has profound economic, and social,     implications given the complex choices women face regarding the timing of childbearing and     the growing burden of infertility. While the inter-individual variability in age at menopause     has a large genetic component and possible environmental influences, to date no studies have     addressed the relationship between oocyte number as reflected by antral follicle count (AFC)     and genetic inheritance.      We hypothesize that ovarian aging, as reflected by antral follicle count, is largely     determined by common genetic polymorphisms that impact the initial oocyte endowment and/or     the rate of oocyte loss over time thus lowering antral follicle count for any given age. We     further hypothesize that antral follicle count will be an improved marker of ovarian aging.     Thus, we propose a study of the genetic and environmental factors that influence age-specific     variability in antral follicle count.   "
202599|NCT00501813|"     The purpose of this study is to compare the effects of different multimodality therapy     strategies (initial hepatectomy followed by transcatheter hepatic arterial chemoembolization     and/or local regional treatments compare with transcatheter hepatic arterial     chemoembolization combined local regional treatments without hepatectomy)in the treatment of     palliative resectable hepatocellular carcinoma with intrahepatic vessels invasion.   "
202600|NCT00501826|"     The goal of this clinical research study is to learn the effectiveness of intensive     chemotherapy given in combination with nelarabine (followed by maintenance therapy) in the     treatment of patients with T cel ALL and T cell lymphoblastic lymphoma. The safety of this     treatment will also be studied.   "
202601|NCT00501839|"     Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS).     Clomiphene citrate (CC) represents the first therapeutic option for treating the anovulatory     infertility in PCOS patients because it is characterized by low costs, limited dose-dependent     side effects, and simplicity of administration and management due to no need for ongoing     monitoring.      Excellent results in terms of ovulations have been obtained using CC. However, only 50% of     patients who ovulates under CC will conceive. The exact explanation for the discrepancy     between the ovulation and pregnancy rates is unknown, but several hypotheses on the     anti-estrogenic effects that CC exerts on the ovary and uterus have been suggested.      To date, few data are available on the optimal schedule for CC administration, and it is     unknown how long patients who ovulate under CC should continue treatment before switching to     second-line ovulation induction therapy. The aim of the study was to define the clinical     benefits of CC administration according to its duration of administration.   "
202602|NCT00501852|"     This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients     with stable COPD, in comparison to an active comparator.   "
202603|NCT00501865|"     The rationale of this study is to assess whether or not food affects the absorption of     GW273225 into the blood of healthy male and female volunteers in order to evaluate whether or     not this drug should be given at a certain time relative to the consumption of food.   "
202604|NCT00501878|"     To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine     for mydriasis in diabetic patient with darkly pigmented irides.   "
202608|NCT00501930|"     This study will assess safety and tolerability when taking GSK189075 at doses that are likely     to be higher than the expected prescribed doses. The study will also measure the level of     GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests     performed on volunteer urine and blood. Each volunteer will take part in 3 dosing periods and     will be given a different dose level at each period (either 2000mg, 4000mg, or a placebo).     Volunteers will not know which of the three doses they are receiving. In each period,     volunteers will dose every morning for three straight days. Before and after dosing, blood     pressure, heart rate, laboratory tests on blood and urine, physical examinations and ECGs     will be taken to assess safety. Volunteers will also be asked to provide information should     they feel they are having a possible effect from the GSK189075. The levels of GSK189075 in     the blood will be assessed by multiple blood draws, most of these will follow the third dose     in each period. Depending on the results from the preceding periods, a fourth period may be     added to the study to assess another dose level. The fourth period, if this is to occur, will     be the same design as the other three periods, and the dose received will be less than     4000mg.   "
202609|NCT00501943|"     This is a double blind, randomized, parallel group design placebo-controlled mono-center     study. Patients will be evaluated within twelve months of CIS onset. Patients with at least 2     silent ovoid T2 bright areas in the deep white matter on their clinic brain MRI scan will be     offered participation in the study. Patients will be randomized to oral riluzole or placebo     (1:1). Patient will take 50 mg of riluzole or placebo once a day for one month. If 50 mg once     a day is well tolerated, patients will then go on 50 mg twice daily for the rest of the     study. They will start Avonex (Interferon beta 1a) therapy 30 mcg IM once weekly 3 months     after study drug (riluzole or placebo) is initiated if their liver function has remained     normal.      Forty patients within twelve months of onset CIS onset will be enrolled at UCSF MS Center.     Patients will be evaluated every month for the first 12 months and every three months     thereafter for a total study duration of 24-month. Enrollment period will last six months.   "
202610|NCT00501956|"     Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of     malnutrition in these patients is dietetic counseling, additional enteral nutrition and     occasionally drug therapy.      In cases where primary treatment of malnutrition is not effective, intradialytic parenteral     nutrition (IDPN)during dialysis therapy may be administered. Using IDPN aminoacids,     carbohydrates and fatty acids as well as vitamins and trace elements can be given to the     patients.      Effectiveness of IDPN has to be verified.   "
202611|NCT00501969|"     The objective of this open-label extension is to assess the safety and tolerability of     long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic     Parkinson's disease   "
202612|NCT00501982|"     The primary objective of this study is to compare two methods of post-delivery stabilization     and subsequent early respiratory care for reducing the need for MV and related secondary     complications, such as BPD, in premature babies at high risk of RDS:        1. Early stabilization on nCPAP        2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery,          and rapid extubation to nCPAP.      The data obtained from this comparison will be applied to test the hypothesis that preterm     neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need     for MV when compared to infants who receive nCPAP alone.   "
202613|NCT00501995|"     Systemic Sclerosis (Scleroderma) varies greatly in clinical manifestations, mode of     presentation, and course. The natural history of this chronic autoimmune disease ranges from     benign to fatal. Patients are classified into limited and diffuse scleroderma defined by the     degree of skin involvement. Patients with limited disease (e.g. the C.R.E.S.T. syndrome)     generally have mild disease and normal survival. However, patients with diffuse cutaneous     scleroderma often have severe multi-system disease that is not only devastating emotionally     and physically but is associated with a 60-70% five year survival and a 40-50% 10 year     survival. No therapies have proven effective in the treatment of scleroderma. Strategy to     treat scleroderma have included attempts to prevent fibrosis with drugs that interfere with     collagen metabolism, attempts to modify the disease process by immunosuppression and attempts     to alter the disease by vasoactive drugs. High dose of corticosteroids and other     immunosuppressive drugs (e.g. chlorambucil, 5-fluorouracil, methotrexate, cyclophosphamide,     cyclosporine) used at conventional doses have not proven curative, but have shown some     benefit for inflammatory features of the disease (e.g. arthritis, myositis, fibrosing     alveolitis).      Both allogeneic and autologous bone marrow transplantation (BMT) have shown to modify and in     some instances reverse a variety of animal models of autoimmune disease. This has prompted     many investigators to propose the use of peripheral blood stem cell transplantation (PBSCT)     for the treatment of autoimmune disease including scleroderma. Unfortunately, this approach     risks infusing untreated autoreactive lymphocyte clones after the immunoablative preparative     regimen. We have previously demonstrated that high-dose cyclophosphamide without BMT can     induce durable and complete remissions in another autoimmune disease, severe aplastic anemia.     Recent data with high dose cyclophosphamide show that it can induce complete remissions in     other autoimmune hematologic disorders. The objective of this study is to determine whether     high dose cyclophosphamide can induce a durable remission in scleroderma patients with     life-threatening disease, and to determine toxicity of high dose cyclophosphamide in high     risk scleroderma patients.   "
202614|NCT00502008|"     The purpose of the study was to evaluate the effectiveness of Coccinia Cordifolia (synonym     Coccinia indica) on the blood glucose levels of newly detected type 2 diabetic patients     requiring only behavioral or lifestyle intervention. The hypothesis of the study is that     there will be significant decrease in the blood glucose levels after a period of 90 days in     the diabetic patients who consumed the coccinia extract.   "
202620|NCT00502086|"     The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the     mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal     syndrome, hepatic encephalopathy, gastrointestinal bleeding, sepsis and hepatocellular     carcinoma) of patients with cirrhosis of the liver secondary to HCV infection in comparison     with placebo, during 96 weeks of treatment.   "
202649|NCT00493610|"     The study will examine the effects of treatment with N-acetylcysteine ( Mucomyst ) 1 gm twice     a day for 30 dyas in 15 patients with hepatitis C. The primary outcome of interest wil be the     changes in oxidant stress as measured by different oxidant stress markers level in sera.     Secondary outcomes of interest will be changes in viral load of hep C and changes in liver     function   "
202650|NCT00493623|"     This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with     osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be     randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated     time on study treatment is <3 months, and the target sample size is 100-500 individuals.   "
203204|NCT00507481|"     The aim of this study was to investigate the relationship between sleep disturbances and     delirium in surgical ICU patients. The study set up to test the hypothesis that the     occurrence of delirium is associated to the alteration of sleep quality and quantity observed     in the critically ill patients.   "
202621|NCT00502099|"     Genotype 4 hepatitis C virus is the cause of approximately 20% of the 170 million cases of     chronic hepatitis C in the world. Although rare in western nations, genotype 4 is the most     common variant of the hepatitis C virus in Egypt and is also found throughout Africa and the     Middle East. Early reports on the treatment of patients with genotype 4 chronic hepatitis C     with interferon-alfa (IFN)-alfa monotherapy indicate poor rates of sustained viral response     (SVR). With the introduction of ribavirin combination therapy and with pegylation of the IFN     alfa molecule, however, response rates have improved dramatically, and current clinical trial     data indicate that SVR rates between 43 and 79% are attainable in genotype 4 patients who are     receiving pegylated IFN alfa plus ribavirin for 48 weeks. Clinical advances to optimize     treatment for each patient have also been made, and tailored treatment options are now being     developed that are comparable to the treatment approaches for genotype 1, 2, and 3 patients.     A treatment duration of between 36 and 48 weeks appears to be optimal for most patients with     chronic hepatitis C genotype 4.The aim of this study is to assess the efficacy and safety of     pegylated interferon alpha 2a in patients with chronic hepatitis C genotype 4 in comparison     to a historical cohort of patients treated with pegylated interferon alpha 2b   "
202622|NCT00502112|"     This study is a phase I, open-label, single-arm, dose escalation trial to determine the     safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small     groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and     lintuzumab and will receive 3-week cycles of combination therapy.   "
202623|NCT00502125|"     The objective of this study is to evaluate the feasibility of using reflectance confocal     imaging to noninvasively detect and diagnose oral dysplasia and early carcinoma.   "
202624|NCT00502138|"     This research project will investigate the effects of pramlintide (Symlin) given by     continuous subcutaneous (under the skin) infusion throughout the day and night, along with     meal doses similar to those injected during conventional pramlintide (Symlin) treatment,     delivered using a second insulin pump, in subjects with inadequately controlled type I     diabetes mellitus who are already using insulin pump therapy. Study participants will wear     two pumps for a four month period, taking insulin in their usual manner and pramlintide     (Symlin) in a similar basal/bolus fashion. Continuous glucose monitors will be worn on three     occasions during the study to assess blood glucose responses to continuous pramlintide     (Symlin) treatment.   "
202625|NCT00502164|"     A study to assess safety and tolerability of AZD2171 after multiple doses in patients with     advanced prostate cancer.   "
202626|NCT00502177|"     Objectives:      The overall objective of this prospective study is to provide a descriptive analysis of the     quality of life of cancer patients enrolled on M. D. Anderson Cancer Center Protocol     2009-0528, A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and     Young Adults with Desmoplastic Small Round Cell Tumor (DSRCT) and Other Non-carcinomas.      Specific Aim 1: To examine the quality of life of patients who undergo HIPEC longitudinally.     It is hypothesized that physical health and functioning concerns, as reported by parent/child     dyads on the Pediatric Quality of Life Cancer Module Version 3.0 (PedsQL) and the PedsQL 4.0     Generic Core Scales, will will remain stable or improve, following the surgical procedures     and peritoneal perfusion described in Protocol 2009-0528.      Specific Aim 2: To assess parent and patient perception of the relative benefit of HIPEC     longitudinally. It is hypothesized that parents and patients will perceive HIPEC to be     beneficial across time, despite the temporary postoperative pain and discomfort that is     associated with the procedure. This will be done by means of a non-validated question that is     specific to the surgery.      Exploratory Aim: To determine whether quality of life following HIPEC varies by demographic     factors (e.g., age, culture), intraoperative cisplatin dose level, or subsequent treatment     modalities. Some patients who undergo HIPEC might subsequently be treated with other Phase II     chemotherapy agents and/or palliative radiation, and comparing quality of life in these     subgroups will be of value. Also the quality of life for groups of patients enrolled in     Protocol 2009-0528 at each intraoperative cisplatin dose level will be compared.   "
202627|NCT00502190|"     Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients     with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea   "
202628|NCT00502203|"     The goal of this clinical research study is to find out if the combination of paclitaxel and     carboplatin chemotherapy can shrink or slow the growth of mixed mullerian tumors (MMMT) of     the uterus.   "
202629|NCT00502216|"     The purpose of this study is to determine whether the combination of naltrexone (Depade) and     varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the     combination is tolerated.   "
202630|NCT00502229|"     Several data demonstrated that both clomiphene citrate (CC) and metformin are two safe and     valid first-step options to induce ovulation in infertile anovulatory PCOS patients.     Notwithstanding a high percentage of patients ovulate under treatment, only ~40% and 60% of     subjects obtain a pregnancy after CC and metformin, respectively.      For these patients, controlled ovarian stimulation (COS) followed by intrauterine     insemination (IUI) could be the next therapeutic step before assisted reproductive techniques     since IUI improves significantly the fertility in couples with unexplained infertility.     Furthermore, to date it is not defined if COS should be obtained using the same ovulatory     agent (CC or metformin) or switching the treatment to gonadotropins.      In this view, the aim of the present study will be to evaluate the best management of     infertile PCOS patients ovulating after CC or metformin.   "
202631|NCT00502242|"     The primary objective of the study is to determine the efficacy of ramipril in preventing a     urinary protein to creatinine ratio (U p/c) greater than 0.5 following conversion to     sirolimus from a calcineurin inhibitor (CNI) in maintenance kidney transplant patients.   "
202632|NCT00502255|"     The purpose of this study is to investigate if telemonitoring results in a decrease in     hospital admissions, with equal quality of care defined as mortality, quality of life and     unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than     usual care in patients with heart failure.   "
202651|NCT00493636|"     The study is being conducted to compare progression-free survival in patients treated with     sorafenib and gemcitabine/capecitabine versus patients treated with placebo and     gemcitabine/capecitabine for locally advanced or metastatic breast cancer that has progressed     during or following treatment with a bevacizumab-containing regimen.   "
202633|NCT00502268|"     Arterial calcification within the coronaries and other vessels is greatly accelerated among     patients with chronic or end-stage kidney disease. The mechanisms leading to increased     calcification are unknown, but include hyperphosphatemia, hyperparathyroidism and altered     vitamin D metabolism. Moreover, recent data demonstrates that circulating carboxy fragments     of PTH (7-84) are physiologic antagonists of intact PTH (1-84) and may directly contribute to     vascular calcification. Current PTH assays no not distinguish between intact and carboxy PTH     fragments leading to an overestimation of intact PTH levels. Because second generation PTH     assays detect both 1-84 and 7-84 PTH fragments, the use of vitamin D analogues to treat     secondary hyperparathyroidism could lead to excessive suppression of 1-84 and a preponderance     of carboxy PTH fragments. Moreover, increased administration of vitamin D analogues amy     contribute to vascular calcifications. To investigate these questions, we plan to investigate     the effect of managing new ESRD patients using conventional and third generation PTH assays     on vitamin D administration and the development of coronary calcification. Hypothesis #1:     Clinical management of secondary hyperparathyroidism in new hemodialysis patients using the     Scantibodies 1-84/7-84 PTH ratio for one year will reduce the amount of Vitamin D     administration resulting in reduced coronary calcification compared to patients in which PTH     management is accomplished by conventional, second generation PTH assay.   "
202634|NCT00502281|"     At the present the first options to induce ovulation in polycystic ovary syndrome with     anovulatory infertility are clomiphene citrate (CC) and metformin. Notwithstanding the     effectiveness of CC and metformin alone or in a sequential or combined regimen, a percentage     of patients ranging from 5% to 30% remain anovulatory. For these patients, the use of     gonadotropins for controlled ovarian stimulation (COS) is indicated.      Moreover, to date it isn't clear if COS should be followed by timed intercourse (TI) or     intrauterine insemination (IUI).      The aim of the present study will be to compare TI and IUI in infertile PCOS patients     undergoing COS in terms of cost-benefit.   "
202635|NCT00502294|"     To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on     Days 1 and 2 to placebo in subjects with IVSR-UC.   "
202636|NCT00493441|"     The study was designed to find the optimum AVN944 dose to use in combination with gemcitabine     in patients with pancreatic cancer and see if the combination of the 2 drugs was more     effective for treating pancreatic cancer than using gemcitabine alone.   "
202637|NCT00493454|"     Primary Objective:        -  Overall Response Rate (ORR).      Secondary Objectives:        -  The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients          and in the responders.        -  Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses          (PR).        -  Time to next anticancer therapy (TTNT).   "
202638|NCT00493467|"     The goal of this clinical research study is to find out if giving (Rituxan) rituximab with     90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma.     The safety of this combination treatment will also be studied.   "
202639|NCT00493480|"     Patients with large esophageal varices who have not yet experienced bleeding, are normally     treated with propranolol, a beta blocking agent that reduces the portal pressure and thereby     diminish the risk of bleeding. 20-40% of the patients do not respond to this treatment or     have to discontinue the treatment because of side effects. The aim of this study is to     evaluate if carvedilol (a combined alfa -beta blocker) has better efficacy and safety than     propranolol in lowering the portal pressure in patients with cirrhosis.   "
202640|NCT00493493|"     Chronic pilonidal disease is a common problem with no ideal treatment. This is a prospective     study that will evaluate the results of surgical pore excision, curettage, and injection of a     regenerative tissue matrix, Cymetra, on patients with chronic pilonidal disease.   "
202641|NCT00493506|"     The purpose of this study is to determine the safety and effects in HIV patients of     supplementation (4-20 fl. oz. daily) with ProAlgaZyme, a novel fermentation product of a     freshwater algae ecosystem, on markers of immune status, dyslipidemia, inflammation and     oxidative stress alone or in combination with HAART (highly-active antiretroviral therapy).   "
202642|NCT00493519|"     The objective of this trial is to examine the cephalic phase insulin response (CPIR) and     pancreatic polypeptide (PP) release as indicators of the cephalic phase occurrence and     magnitude to palatable food stimulus in anorectic and bulimic subgroups as compared to     healthy controls   "
202643|NCT00493532|"     This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in     women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3     months. The anticipated time on study treatment is 3-12 months, and the target sample size is     100 individuals.   "
202644|NCT00493545|"     The purpose of this study is to determine the safety and tolerability of HspE7 and Poly-ICLC     when given together   "
202645|NCT00493558|"     The purpose of this study is to gather information on the effectiveness of a new spine     implant for patients who require spinal fusion surgery. Based on this information, we hope to     create a standard of good performance, or benchmark, against which future studies on this     spine implant can be compared. By creating this benchmark we hope to improve care for     patients who require spinal fusion surgery.   "
202646|NCT00493571|"     The goal of this clinical research study is to find the highest tolerable dose of gimatecan     that can be given to treat myelodysplastic syndrome (MDS).   "
202647|NCT00493584|"     The purpose of this study is:      A) To determine whether patients with a certain type of heart attack (NSTEMI) can be reliably     diagnosed in an ambulance using telemedicine. This is mandatory if NSTEMI patients in the     future are to be treated with acute balloon angioplasty (primary PCI).      B) To evaluate whether primary PCI compared with the current regimen of initial medical     stabilization and sub-acute PCI results in reduction of infarct-size in NSTEMI-patients.   "
202648|NCT00493597|"     clinically relevant in stent restenosis occurs in 5-10% of the non-diabetic patients treated     with a coronary bare metal stent. Recent research has identified endothelial progenitor cells     as well as dendritic cells as components of neointima. Numerical and functional evaluation of     endothelial progenitor and dendritic cells at the time of coronary stent implantation is     assessed and the relation with clinical and/or angiographic restenosis at 6 months post-stent     implantation is evaluated.   "
202654|NCT00493675|"     Endoscopic sphincterotomy and temporary stenting is a routine treatment for post     cholecystectomy cystic duct leakage. The draw back is that the plastic stent need to be     removed later in a second intervention. Our studies with animal models have demonstrated that     biodegradable biliary stent is at least as good as conventional plastic stent to heal that     kind of leakage. In this pilot study the biodegradable biliary stent is inserted     endoscopically to patients with confirmed cystic duct leakage to demonstrate the efficacy in     human setting.   "
202655|NCT00493688|"     To validate a new method for assessing perioperative risk in the cancer patient undergoing     major cancer surgery.      In this proposed study researchers will:        1. Measure preoperative energy reserve capacity (fitness)        2. Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas          exchange metabolism   "
202656|NCT00493701|"     This study is designed to predict weight gain overtime after a high fat diet.   "
202657|NCT00493714|"     Primary Objectives:        1. To determine the proportion of patients who experience partial or complete recollection          of symptoms of delirium and the level of distress associated with this recall.        2. To determine caregiver's level of distress associated with the patient's episode of          delirium.   "
202658|NCT00493727|"     The study will look at the effect of 30 days of treatment of 15 diabetics with proteinuria     with N-acetylcysteine ( Mucomyst ) at a dose of 1 gm twice a day by mouth. The primary     outcome that will be measured is change in the oxidant stress as measurable by changes in the     serum level of isoprostane, Glutathione peroxidase, aconitase and Total oxidant stress.     Secondary outcomes measured will be changes in proteinuria and kidney function as measured by     spot urine pr/cr and estimated GFR by MDRD formula.   "
202659|NCT00493740|"     The objective of this trial is to examine the cephalic phase insulin response (CPIR) and     pancreatic polypeptide (PP) release as indicators of the cephalic phase occurrence and     magnitude to palatable food stimulus (chocolate cake) in oncology patients before and after     chemotherapy treatment as compared to healthy controls . This may enlighten our understanding     of the etiology of taste dysfunction and anorexia during chemotherapy treatments.   "
202660|NCT00493753|"     The aim of this pilot study was to evaluate whether acupuncture is safe and acceptable to     people with systemic lupus erythematosus (SLE). Twenty-four SLE patients were assigned     randomly to receive either 10 sessions of acupuncture, 10 sessions of a minimal-needling     control intervention, or their usual medical care alone. It was hypothesized that acupuncture     would be safe for people with SLE, and that participants would be able to complete their     assigned treatment within 5 to 6 weeks.   "
202661|NCT00493766|"     This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral     formulation) alone and in combination with docetaxel in patients with progressing hormone     refractory prostate cancer. This study is designed to determine the maximum tolerated dose of     LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a     day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic     profile   "
202662|NCT00493779|"     The purpose of the study is to look at the biomarkers of inflammation and platelet activation     in patients with drug eluting stents implanted approximately 12 months ago on aspirin and     statin, for a 4-week period after the routine discontinuation of clopidogrel   "
202663|NCT00493792|"     A prospective, randomized, blinded clinical trial is proposed to compare Stryker Orthopaedics     N2Vac Polyethylene to their X3 Polyethylene when used with the Triathlon Posterior Stabilized     (PS) total knee system.   "
202664|NCT00493805|"     This is a Phase 3b/4, prospective, open-label, randomized, multicenter study of peginterferon     alfa-2b plus ribavirin in participants with chronic hepatitis C, genotype 1. The study     consists of two parts: (1) a noninterventional arm (HOMA IR <= 2) and (2) an interventional     arm (HOMA IR > 2), where HOMA IR is the insulin resistance index for the participants     calculated by fasting insulin (uU/mL) x [fasting glucose (mmol/L)/22.5]. Participants in the     noninterventional arm are treated according to the European labeling and response rates are     evaluated at Month 1 (optional), 3, 6, 12, and follow up. Participants in the interventional     arm are treated with PEG-Intron 1.5 ug/kg (subcutaneous) once weekly plus weight-based     REBETOL 800-1400 mg (oral capsules) daily for a variable period depending on their response     at Week 12: (1) HCV-RNA positive with < 2-log drop in viral load, treatment will be     discontinued; (2) HCV-RNA positive with >= 2-log drop in viral load; participants will be     randomized (1:1) to Group A (stop treatment at Week 48) or Group B (stop treatment at Week     72); and (3) HCV-RNA negative, treatment will be changed to be according to the European     labeling and response rates will be evaluated at Month 6, 12, and follow up. All participants     will go on with their treatment after Week 12 until the results of the HCV polymerase chain     reaction (PCR) are available (maximum of 4 weeks).   "
202665|NCT00493818|"     This study is a first time in human, Phase I, open-label study to determine recommended doses     and schedules, based on maximum tolerated doses and biologically active doses, for the AKT     inhibitor GSK690693.   "
202666|NCT00493831|"     The purpose of this prospective, open-label, clinical trial is to establish the feasibility     and validity of exhaled breath condensate (EBC) biomarkers for use in studies designed to     evaluate harm reduction strategies of smoking. This will be accomplished by measuring     selected markers in EBC believed related to the pathogenesis of lung disease before and after     a smoking cessation intervention.   "
202667|NCT00493844|"     The investigators' objective is to compare a new strategy combining clinical history and     NT-proBNP levels versus the usual care, consisting of early exercise testing, for decision     making in patients presenting to the emergency department with acute chest pain,     non-diagnostic electrocardiogram and normal troponin. The investigators hypothesised that the     new strategy combining clinical risk score and NT-proBNP will reduce the number of     hospitalisations without increasing the number of events during the follow-up.   "
202681|NCT00494039|"     Objective: To test the hypothesis that the shorter half-life of Pd-103 versus I-125, will     increase the rate of tumor eradication.      Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma     (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160     Gy) versus Pd-103 (115 Gy).   "
203205|NCT00507494|"     The purpose of this study is to test whether pioglitazone is able to prevent the progression     of diabetic nephropathy in kidney transplant recipients with diabetes mellitus.   "
202668|NCT00493857|"     This study will determine if nimotuzumab provides a benefit in this type of cancer when given     in combination with irinotecan.      The study will test:        -  How long any good effects last.        -  How bad any side effects are.      Objectives:      Primary:      The primary goal is to assess the Objective Response Rate (ORR) that the combination of     irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic     colorectal cancer      Secondary:        -  To assess the incidence of Grade 2 or greater acneiform rash or infusion reaction,          allergic reaction or anaphylactoid reaction AEs in patients with irinotecan-refractory          metastatic colorectal cancer following weekly or 2-weekly nimotuzumab schedules;        -  To assess Progression-Free Survival (PFS), defined as time from date of randomization          until date of disease progression (clinical or radiological) or death due to any cause,          for the two nimotuzumab schedules;        -  To assess the rates and durations of Stable Disease (SD) following weekly or 2-weekly          nimotuzumab schedules;        -  To assess the Time to Disease Progression (TTP) following weekly or 2-weekly nimotuzumab          schedules;        -  To evaluate ORR in patients who are identified as having primary irinotecan resistance          following weekly or 2-weekly nimotuzumab schedules;        -  To evaluate Overall Survival (OS) following weekly or 2-weekly nimotuzumab schedules;        -  To compare the two dosing schedules of nimotuzumab with respect to objective response          rates and safety;        -  To evaluate the overall safety and toxicity profiles of these two dose regimens of          nimotuzumab;        -  To evaluate trough levels and accumulation of nimotuzumab in serum of patients receiving          the drug on weekly or 2-weekly regimens.   "
202669|NCT00493870|"     The purpose of this research study is to find out what effects (good and bad) TC or TAC has     on early stage HER2- breast cancer.   "
202670|NCT00493883|"     The purpose of this study is to provide supervised access to treatment with TheraSphere® to     eligible patients with primary and metastatic cancer and evaluate response to treatment,     survival and toxicity.      The study has the following objectives:        -  Provide supervised access to treatment with TheraSphere to eligible patients with          primary and metastatic cancer to the liver.        -  Evaluate patient experience and toxicities associated with TheraSphere treatment        -  Evaluate predisposing factors that may influence results and toxicity   "
202671|NCT00493896|"     This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding     and development of thrombocytopenia in the medical ICU population.   "
202672|NCT00493909|"     The purpose of this study is to compare whether epidural analgesia would provide equal     analgesia than combining intrathecal opioids with thoracic paravertebral local anesthetics.   "
202673|NCT00493922|"     1) To compare in a setting where microscopy for malaria is available whether introducing     rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT     v microscopy). 2) To compare whether, in a setting where microscopy for malaria is not     available, introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial     drugs and antibiotics (RDT v clinical diagnosis).   "
202674|NCT00493935|"     Low blood sugar at night (called nocturnal hypoglycemia), can often happen without symptoms     and can last for a long time. Doctors often suggest that patients take a bedtime snack to try     to prevent low blood sugar at night from happening, but it is not known what type of snack is     best to take. We are conducting a study to evaluate how two different types of snacks affect     how often the blood sugar is too low overnight. One snack will be a primarily carbohydrate     snack and the other will be a carbohydrate snack with fat. The snacks will be provided by the     study.      As part of the study, a continuous glucose sensor (the Freestyle Navigator) will be worn     overnight. The Freestyle Navigator was developed by Abbott Diabetes Care. This sensor uses a     glucose oxidase based electrochemical sensor, and is designed to measure blood glucose levels     in a range of 20-500 mg/dl. The sensor is inserted subcutaneously and measures interstitial     glucose. In human studies the interstitial glucose levels generally lag behind the blood     glucose by 3 to13 minutes.(27, 28)      The Freestyle Navigator, provides a glucose reading every 60 seconds (or 1440 readings a     day). Each sensor is designed to provide readings for up to 120 hours. It has alarms for     hypoglycemia and hyperglycemia and for projected high and low glucose values. The alarm set     points can be adjusted by the user. The Navigator also has a trend arrow indicating the     glucose rate of change (>-2 mg/dL/min, -2 to -1 mg/dL/min, -1 to 1 mg/dL/min, 1 to 2     mg/dl/min, and >2 mg/dl/min). Subjects can enter events, such as when they took insulin, ate,     or exercised. The sensor requires calibration values to be entered 3 times during the first     day of wear, and then 2 additional times during the 5-day wear period. The values are entered     directly into the Navigator which has a Freestyle home glucose meter built into the unit. The     Navigator has not yet been approved by the FDA. The Navigator currently under review by the     FDA will limit sensor wear to 3 days.      This study is being done to see if there is a difference in low blood sugar overnight after     having a bedtime snack made up of carbohydrate compared to a carbohydrate snack with more     fat.   "
202675|NCT00493948|"     The purpose of this study is to evaluate an approved, portable device for assessing Sleep     Disordered Breathing in Congestive Heart Failure.   "
202677|NCT00493974|"     Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is caused by     cigarette smoking or by breathing in other lung irritants, including pollution, dust, or     chemicals. The purpose of this study is to evaluate the effectiveness of zileuton, a     medication that is used to control asthma symptoms, at reducing the length of a hospital stay     for adults who are hospitalized for a COPD exacerbation, or worsening of COPD symptoms.   "
202738|NCT00502567|"     A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of     AZD2171 when administered with various anticancer regimens (part A) and to confirm the     tolerability of its combination with FOLFOX (part B).   "
202678|NCT00493987|"     In normal men, the male hormone testosterone affects a number of things in the body including     muscle function and sexual function. An enzyme in the body called 5-alpha reductase converts     testosterone into another form called dihydrotestosterone (DHT) which has slightly different     effects. The purpose of this study is to find out how different amounts of the two different     forms of testosterone affect muscle function and sexual function in healthy young men like     you. This will be done by giving the men participating in the study different combinations of     hormone-related medication for 20 weeks and making measurements before, during and after the     medications to look for changes in lean body tissue, muscle size, muscle strength and leg     power, as well as sexual function and sexual activity in all participants.   "
202679|NCT00494013|"     The purpose of this study is to examine the effectiveness and safety of insulin lispro     protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults     with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the     secondary objectives.   "
202680|NCT00494026|"     This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed +     carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell     lung cancer   "
202682|NCT00494052|"     Coronary heart disease (CHD) is the leading cause of death in the United States, but fewer     than half of all individuals at risk for CHD take advantage of proven strategies to lower     their chances of developing this disease. This study will assess the effectiveness of Heart     to Heart, a Web-based program, at educating people on ways to incorporate CHD risk-reduction     strategies into their lives.   "
202683|NCT00494065|"     The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal     Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192     patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term     (after 12 weeks) and long-term (after 52 weeks). The primary outcome variable is leg pain and     secondary outcome variables include low back pain, disability, bothersomeness and frequency     of symptoms, general health status, and fear avoidance behavior.      Secondary aims are to describe and estimate between group differences in patient     satisfaction, improvement, medication use, straight leg raise, torso endurance, and three     biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response     to sudden load. Patient perceptions of treatment will also be assessed.   "
202684|NCT00494078|"     The purpose of this study is to determine whether, real-time continuous glucose monitoring in     critically ill patients with intensive insulin therapy would increase the percentage of time     of normoglycemia, defined as glucose levels below 110 mg/dl.   "
202685|NCT00494091|"     This is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in     Asian patients with advanced renal cell carcinoma. The trial is only being conducted in     Japan, Korea, and China.   "
202686|NCT00494104|"     Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D     deficiency during winter. This trial is designed to determine how much supplemental vitamin D     breastfed infants need to receive in order to remain free of vitamin D deficiency   "
202687|NCT00494117|"     The purpose of the study is to investigate respiratory indicators for clinically important     changes in Heart Failure status over time.   "
202688|NCT00494143|"     To determine if below-knee amputees will walk with better efficiency wearing a CESR foot     which stores energy at heel strike and releases energy releases energy during push-off.   "
202689|NCT00494156|"     Originally thought to be a rare occurrence, BCVI are now diagnosed in approximately 1% of     blunt trauma patients. Initially BCVI were thought to have unavoidable devastating neurologic     outcomes. But early reports suggested anticoagulation might decrease these events. If     untreated, carotid artery injuries (CAI) have a stoke rate up to 50% depending on injury     grade, with increasing stroke rates correlating with increasing grades of injury. Current     studies report early treatment with antithrombotics - either heparin or anti-platelet agents     - in patients with BCVI markedly reduces stroke rates and resultant neurologic morbidity. As     reports of bleeding complications have altered heparin protocols in these patients, the use     of antiplatelet agents is attractive. Although heparin has been has been proposed as the gold     standard treatment due to its initial empiric use, no comparative studies of antithrombotic     agents has been performed.      In sum, Grade I-III blunt carotid and vertebral arterial injuries (BCVI) have the potential     for stroke, and should be treated. Heparin has not been shown to clearly improve healing     rates compared with antiplatelet therapy. The purpose of this study is to determine whether     systemic anticoagulation alters the course of Grade I-III BCVI compared with antiplatelet     therapy. The investigators study hypothesis is that Grade I-III BCVI will heal or progress to     pseudoaneurysm formation, independent of systemic antithrombotic regimen, and that the     combination of aspirin and clopidogrel is equally efficacious in preventing neurologic     symptoms compared to systemic heparin associated with Grade I-III BCVI.   "
202691|NCT00494182|"     The goal of this clinical research study is to learn if the combination of carboplatin,     paclitaxel, and sorafenib can help to control the disease in patients with head and neck     cancer. The safety of this drug will also be studied.   "
202692|NCT00494195|"     Limb girdle muscular dystrophy type 2D (LGMD2D) is a genetic disease that affects skeletal     muscle. Insufficient levels of the protein alpha-sarcoglycan result in muscle weakness that     worsens over time. The purpose of this study is to evaluate the safety and effectiveness of     gene therapy in treating children and adults with LGMD2D.   "
202693|NCT00494208|"     TDSM will study the physiology of testosterone in women ages 21-60 who have had surgical     menopause (uterus and both ovaries removed). Testosterone is commonly thought of as a male     hormone thus being that it is the male's primary hormone. Women produce testosterone in much     smaller amounts and despite this, testosterone still plays a significant role. Fifty percent     of a women's testosterone is made in her adrenal glands (glands that sit on top of the     kidneys) and fifty percent is made in her ovaries. When a woman has her ovaries removed it is     thought that her testosterone levels decrease rapidly and significantly. This study will be     examining testosterone's role in sexual function, general well being, muscle performance,     cognitive function, carbohydrate metabolism and muscle and fat distribution.      The study is 14 months long with weekly to monthly visits. The subjects will be placed on the     estrogen patch for the duration of the study. They will also be given weekly injections of     testosterone or placebo for 6 months. During the testosterone treatment phase the women will     be separated into 5 groups. The groups include a dose of testosterone that is very low, low,     medium, high and placebo. A placebo looks and feels similar to testosterone; however it does     not have testosterone in it. We use this to test if the subject is having a response to the     testosterone itself or the thought of receiving testosterone. Neither the subject nor the     investigators will know the dose until the end of the study.   "
202708|NCT00494403|"     The purpose of this investigation is to determine the effects of chronic ankle instability on     cervical spine and knee proprioception as measured using joint position sense to investigate     whether correlation can be drawn between the two.   "
202741|NCT00502606|"     The effect of Antibacterial Nanoparticles, Incorporated in cement, on S.mutans in the margins     of provisional restorations is going to be examined clinically by using two kinds of     provisional cement 1. cement with out antibacterial nanoparticles.      2.cement with small addition of IABN. after one week in the mouth the crowns are to be     removed and examined for the presence and quantity of s. mutans. in vitro tests of the same     has shown significant reduction in bacterial population around the provisional cement as     compared to the regular cement.   "
202694|NCT00494221|"     This Study is in two parts, the first part is to make sure that combining a potential new     treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal     cancer is safe. Once this part is complete and it is decided that it is safe to continue the     Study will the go on to look at the efficacy of the two drugs together. This will be done by     studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy     cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real     cediranib (AZD2171) tablets. Using dummy tablets means the study is 'blinded' and that     non-one can tell the difference between the two treatment groups. This kind of study design     is done to try to avoid the chance that the results might be biased in some way. The overall     aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard     treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results.     That is, it's better than giving standard treatment alone in helping to prevent progression     of mCRC.   "
202695|NCT00494234|"     The purpose of the study is to see if the drug KU 0059436 (olaparib) is effective and well     tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced breast     cancer and for whom no curative therapeutic option exists.   "
202696|NCT00494247|"     Randomized prospective study to compare the efficiency and safety of EPC-capture stents     (Genous, OrbusNeich) and bare metal stents with concommitant high dose atorvastatin in     reduction of neointimal formation assessed by quantitative coronary angiography and IVUS.     Also the association between the function (transcriptional activity, migration) and number of     circulating EPCs and angiographic outcomes will be investigated.   "
202697|NCT00494260|"     The purpose of this study is to evaluate the efficacy of a social learning and cognitive     behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP).   "
202698|NCT00494273|"     There has not been a great deal of research involving Haitian American adolescents and HIV     risk reduction. The purpose of the study is to learn better ways to teach teenagers about     living healthy by educating these children about how to make good choices about things like     eating healthy, exercise, and sexual behavior. The primary focus of the proposed study is to     understand the mechanisms of adopting safer sex practices among Haitian American (H-A)     adolescents. We will enroll 160 male and 160 female participants to achieve the target sample     of 272 participants at the 12-month follow-up time point.   "
202699|NCT00494286|"     This study will determine the effectiveness of abuse-focused cognitive behavioral therapy     that is provided by a community health clinic in addressing the behavioral and emotional     health needs of children and adolescents whose parents have used physical disciplinary     action.   "
202700|NCT00494299|"     Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.   "
202701|NCT00494312|"     The purpose of this study is to determine the liver safety of pioglitazone, once daily (QD),     versus glyburide taken with metformin and insulin.   "
202702|NCT00494325|"     In the industrialised world age-related macular degeneration (ARMD) is the leading cause for     legal blindness beyond the age of 50 years. Recent studies indicate that the amount and     status of the macular pigment (MP) may play a central role in the development and progression     of the disease. It has been demonstrated that the MP density can be increased by dietary     supplementation. First results of MP density measurements with a modified confocal laser     scanning ophthalmoscope show that this method allows to quantify the MP in a clinical     setting. The aim of this study is to assess the peak MP density as well as the MP     distribution in relation to the risk for ARMD. We will establish reference values for MP     density distribution in a normal population and compare these to values obtained from     patients with age related maculopathy in a cross-sectional study. For all MP density     measurements we will use a modified scanning laser ophthalmoscope and dietary intake of     macular pigment will be assessed using a Food Frequency Questionnaire. Clinical examinations     will include ETDRS visual acuity, binocular ophthalmoscopy, colour fundus photography and     autofluorescence imaging. The results of our study will help assess the relationship of     macular pigment density and distribution with ARMD. Additionally, we will be able to identify     patients with low MP density, and probably improve the early diagnosis of patients at high     risk for developing ARMD. This will be the basis for dietary supplementation of lutein and/or     zeaxanthin in patients with high risk for ARMD due to low macular pigment values.   "
202703|NCT00494338|"     A multi-center controlled, non-comparative open Phase II trial of docetaxel and celecoxib in     patients with metastatic androgen independent prostate cancer where efficacy is measured by     PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at     least 4 weeks apart.   "
202723|NCT00502372|"     The focus of this study is to look at the role of nutrition in the healing of pressure     ulcers. The purpose of this study is to test whether the rate of healing of pressure ulcers     is increased in those patients receiving a nutritional supplement of amino acids and the     leucine metabolite, B-hydroxy-B-methylbutyrate is enhanced when compared to control patients     receiving a supplement containing only one of the proteins in the experimental supplement   "
202704|NCT00494351|"     -  Determination of the short and long term efficacy of NdYag laser for treatment of          Hidradenitis suppurativa, which is an inflamed, deeper follicular disorders.        -  Determination of patient tolerance of discomfort associated with NdYag laser treatment          for Hidradenitis suppurativa.        -  Determination of the impact of this condition on quality of life and if there is any          impact of therapy in the dermatology quality of life index.        -  Evaluate the histopathologic changes of YAG therapy on affected skin      Second phase of study:        -  Prospective, controlled clinical and histologic study of patients with Hurley Stage II          HS disease.        -  19 patients of skin types II to VI with Hurley Stage II hidradenitis suppurativa lesions          of the axilla and groin. This is a different set of patients than those treated in the          first phase of the study above. This study primarily focuses on and further          characterizes the histologic changes after laser treatment.   "
202705|NCT00494364|"     The middle ear is an airspace located behind the eardrum that consists of two connecting     compartments. The compartment directly behind the eardrum is called the tympanum and contains     the three small bones of the middle ear, the hammer, anvil and stapes, that function to     transfer eardrum movements to the inner ear so that you can hear. Behind the tympanum is the     mastoid cavity which is a larger airspace subdivided into small air cells of unknown     function. For normal hearing, it is important that the air pressure in the middle ear is     similar to that of the environment so that the eardrum can move freely in response to sounds.     The air pressure of the environment is not constant and is affected by changes in weather     conditions (high and low pressure systems that move through the area) and by changes in     elevation above sea level (the fullness in your ears that can be noticed when you ride in an     elevator or in an airplane). The air pressure in the middle ear also changes because middle     ear gas is constantly leaking from that airspace to the blood that flows through the walls of     the middle ear. These effects (changing environmental air pressures and changing middle ear     air pressure) are independent and cause the middle ear and environmental pressures to be     different from each other. Periodically and during swallowing or yawning, any existing     difference between middle ear and environmental air pressure is reset to zero by the opening     of a biological tube (the Eustachian tube) that connects the middle ear to the back of the     nose. This allows gas flow between the middle ear and the environment which increases or     decreases middle ear pressure to the level in the environment at that time. Most people     cannot open their Eustachian tubes at will and the number of automatic openings varies from     infrequent to often in a population. Whether or not a person's usual frequency of Eustachian     openings is good enough to keep the middle ear pressure the same as environmental levels     depends on how fast gas is lost from the middle ear by gas leakage (diffusion) to blood. For     example, in ears with very slow rates of gas loss, the Eustachian tube does not need to open     very frequently to keep the middle ear at environmental pressure. Some researchers believe     that the mastoid compartment functions to control the rate of gas loss to blood, with larger     mastoid volumes associated with lesser rates of middle ear gas loss. In this experiment, the     investigators plan to test this by measuring mastoid and tympanum volumes using Computer     tomography (CT) and the rate of blood to middle ear gas transfer using a technique that     involves breathing air that contains laughing gas (Nitrous Oxide=N2O) and measuring middle     ear pressure change using tympanometry (a technique that involves putting an ear plug into     the ear canal and measuring the pressure). From past studies in patients undergoing short     surgical or dental procedures, the investigators know that breathing gas mixtures that     contain N2O will increase the blood levels of that gas, cause gas to go from blood to the     middle ear and increase middle ear pressure. The investigators predict that the rate of     change in middle ear pressure while breathing a gas mixture containing 25% N2O and the normal     oxygen level (20%) of air will be less for those ears with larger mastoid volumes. If the     investigators prediction is correct, they will be able to explain why ears with larger     mastoid volumes are better able to keep their pressure like that of the environment even if     the Eustachian tube does not open often.   "
202706|NCT00494377|"     The primary purpose of this study is to determine if duloxetine plus non-drug intervention is     more effective than duloxetine alone in patients with depression.   "
202707|NCT00494390|"     The purpose of this study is to determine whether a new non-contact biometer, is as accurate     as the the available gold-standard.   "
202709|NCT00494416|"     IPT/SP was adopted in 2005 by The Ministry of Health (MoH) of Burkina Faso to replace     chemoprophylaxis with CQ in pregnancy. The new strategy is being implemented but no delivery     approach was defined and presumably IPT/SP will only be delivered to pregnant women     presenting at ANC visits. It would be of extreme importance to ensure a better coverage and     higher compliance to make the new strategy effective. In order to obtain a more efficient     IPT/SP programme with a good level of compliance and coverage, several delivery approaches     beside ANC should be explored.      The study site will be in Pissy health district covering both peri-urban Ouagadougou city and     rural areas. Participants include pregnant women irrespective of gravidity residing in the     study area.      The study is a prospective comparative study of 3 different approaches of delivering IPT/SP     in the catchment areas of rural health facilities. The approaches will be the following:        1. Passive health centre based delivery approach (PHC). IPT/SP will be delivered to          pregnant women presenting to the health centre for ANC visits.        2. Joint, with an advanced strategies delivery approach (JAS). In addition to passive          delivery at health centres, the pregnant women will be reached during preventive          activities the health staff carry out regularly in villages, such as immunization,          health promotion, and even ANC visits.        3. Community based distribution delivery approach (CBD). In addition to passive delivery at          health centres, the pregnant women will be reached by traditional birth attendants          (TBAs) or representatives of village women's associations (RWAs). Each approach will be          implemented in a zone constituted by the catchment area of a number of health centres to          achieve the required sample size. The zones will be randomly assigned to a delivery          approach. The main outcomes to be measured are: a) the coverage of IPT, b) compliance,          c) infection prevalence, d) Hb level, e) difficulties and constraints of each approach,          f) the acceptability to population and health staff and g) the performance of each          approach to deliver IPT /SP. to be able to identify a significant increase in coverage          of 10%, each group should be composed of n = 3841 pregnant women.      Cross sectional surveys will be carried out at the beginning, during and at the end of the     study period. The study will be carried out over 24 months from June 2007.   "
202710|NCT00494429|"     The purpose of this study is to improve the dosing of morphine in critically ill premature     neonates.   "
202711|NCT00494442|"     The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in     treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for     whom no curative therapeutic option exists.   "
202712|NCT00494455|"     The purpose of this study is to determine whether subcutaneous continuous glucose monitoring     in critically ill patients is clinically feasible accurate and reliable.   "
202713|NCT00494468|"     This is a multicenter trial to evaluate the single-dose safety, tolerability and     pharmacokinetics-pharmacodynamics of Zolpidem in a group of children with sleep disturbances     stratified by age and dose.   "
202714|NCT00494481|"     To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using     the progression event count methodology   "
202715|NCT00494494|"     Purpose: Study the effect of nepafenac ophthalmic suspension 0.1% to prevent post-operative     cystoid macular edema following uncomplicated cataract surgery      Participants: Patients having cataract surgery at UNC who meet eligibility criteria      Procedures (methods): Patients will have pre and post-operative vision measured and optical     coherence tomography (OCT) testing, also cataract density and intraoperative     phacoemulsification parameters including ultrasound power and ultrasound time will be     measured. Patients will be randomized into two groups. Group 1 will be treated with standard     post-operative cataract management. Group 2 will be treated with standard post-operative     cataract management plus topical nepafenac for one month. Post-operative macular thickness     will be studied by analyzing the visual acuity and OCT measurements at two months post     surgery.   "
202716|NCT00494507|"     The purpose of this study is to compare Dichlorphenamide with placebo (an inactive substance)     for prevention of episodes and for improvement of strength in hyperkalemic (HYP) and     hypokalemic (HOP) periodic paralysis. This study will also look at the long-term effects of     Dichlorphenamide in periodic paralysis.   "
202717|NCT00494520|"     Adults who sustain brain damage due to stroke, traumatic injury or surgery may develop     difficulty finding words. This study compares the effectiveness of two behavior-based     programs to improve picture naming ability in these individuals.   "
202718|NCT00502307|"     This phase 2 trial is evaluating the antineoplastic activity of tivozanib (AV-951) in     treating patients with recurrent or metastatic renal cell cancer. Tivozanib (AV-951) is a     VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking     blood flow to the tumor.   "
202719|NCT00502320|"     The purpose of this study is to determine whether treating sleep difficulties in patients     with seasonal affective disorder also improves their depressive symptoms.   "
202720|NCT00502333|"     The purpose of this study is to evaluate the influence of coping strategies and     catastrophizing thoughts on disability and the prognosis of back and neck pain in patients     treated within the Spanish National Health Service. Patients will be given a visual analog     scale (VAS) to rate intensity of pain, the Roland Morris Questionnaire (RMQ) or the Neck     Disability Index (NDI) to rate the degree of disability, and the Coping Strategies     Questionnaire (CSQ) to rate coping strategies and catastrophizing. Questionnaires will be     given at baseline and three months later.   "
202721|NCT00502346|"     The primary objective of the study is to compare the effect of PM101 I.V. administered as an     immediate intravenous bolus versus placebo on systolic blood pressure. Secondary objectives     include evaluation of change from baseline in heart rate and change from baseline to the     lowest value in mean arterial pressure and diastolic pressure.   "
202725|NCT00502398|"     Patients with hemolytic disorders (e.g. sickle cell anemia or thalassemia) are known to     develop pulmonary hypertension. Hemolysis is where red blood cells are destroyed and their     contents released into the circulation. It is thought that these red-cell contents cause     constriction and thrombosis of the blood vessels in the lungs. Conversely, it is possible     that patients with pulmonary hypertension have hemolysis.      In this study we will be drawing blood from a range of patients and normal controls for a     panel of blood tests related to hemolysis.   "
202726|NCT00502411|"     The goal of this clinical research study is to learn if the combination of radiation therapy     plus low dose doxorubicin chemotherapy given after surgery is effective in the treatment of     sarcoma. The safety of this treatment will also be studied.   "
202727|NCT00502424|"     The purpose of the present study was to evaluate the effectiveness of a nighttime positioning     hand splint in patients with RA in terms of pain, grip and pinch strength, upper limb     function, quality of life, and patient satisfaction. The hypothesis is that the stabilization     of hand during nighttime could decrease pain and consequently improve quality of life.   "
202740|NCT00502593|"     The present study is designed to evaluate in children (aged between 3 and 9 years) the     immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A)     administered following a two-administration schedule (21 days apart). Subjects in the control     group will receive Fluarix. The Protocol Posting has been updated in order to comply with the     FDA Amendment Act, Sep 2007.   "
202728|NCT00502437|"     Antigagging effect of kytril (granisetron) an antiemetic drug in dental situations      Gagging in dental situations can be a problem to the patient and the operating dentist. There     are not proven methods of eliminating this reflex which sometimes will not allow routine     quality dental care.      Pharmacological and behavioral approaches to eliminate this reflex have been tried with     limited success.      This suggested study will test a potent antiemetic drug used in other clinical situations     such as antineoplastic treatment. Granisetron is a potential antagonist for the     5-hydroxytryptamine3-receptor - 5HT(3), The drug binds to the receptor and blocks the effect     of nausea and vomiting. Kytril mechanism of action was successfully proven for various     medical situations as a potential antiemetic agent. Our Center for dental sedation and     anesthesia in the oral medicine department have received approval to use Granisetron as an     antigagging drug in dental situations based on several pilot studies conducted in other     medical centers in different clinical situations such as strabismus corrections, post     hysterectomy and others. Our preliminary clinical impression is that pre-emptive IV     administration of this drug to patients with increased gag reflex is beneficial.      In our research we try to investigate the possibility of using kytril in dental situations.      In the first stage of this research we will study the INTRAVENOUS use of this drug and its     effects On normal subjects compare them to themselves with placebo. According to the results     of this study we will go on to the second stage of the research and try the same drug under     oral administration.      The purpose of this study is to test the antigagging effect of this drug in a controlled     manner in dental situations.      Our working hypothesis is that administration of this drug in dental situations with success,     will allow many patients to receive good dental care   "
202729|NCT00502450|"     Following acute mastoiditis there is a possible risk to develop hearing loss. The cause could     be either possible involvement of the inner ear, or in cases that underwent surgery,     secondary to the effect of the drill's noise. Extended hearing test will be performed for 25     children that suffered acute mastoiditis that resolved with conservative treatment and     compared with 25 children that needed surgical intervention.   "
202730|NCT00502463|"     The purpose of the trial is to determine the feasibility of an induction chemotherapy with     radio-immunotherapy in patients with head and neck cancer stage III/IV   "
202731|NCT00502476|"     To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the     incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting.   "
202732|NCT00502489|"     After an episode of acute respiratory failure requiring mechanical ventilation, weaning the     patient from the ventilator may be difficult. Discontinuation of ventilation is estimated to     take up to 40% of the total duration of ventilatory support. Approximately two- thirds of     patients can be disconnected from the ventilator after a spontaneous breathing trial.     Prolongation of mechanical ventilation may increase the risk of adverse events such as     infections and can increase morbidity and mortality.      Identifying weaning readiness early and reliably is therefore crucial. Weaning protocols     developed to assist in identifying weaning readiness have been shown to shorten duration of     mechanical ventilation, most notably the weaning period.      Closed loop knowledge-based systems serve as a continuously applied weaning process that     automatically reduce ventilatory assistance according to patient ability and indicate when     the patient is ready for disconnection. No data on the use of such a computer driven system     (CDS) in elderly patients requiring prolonged ventilation in weaning centers (non ICU) have     been reported.      The Objective of the present study is to evaluate the ability of a computer driven system to     predict weaning readiness and to compare this to a physician-directed protocol. The CDS     continuously adapts pressure support, gradually decreasing ventilator assistance according to     patient ability, and thus indicates weaning readiness. Patients who maintain spontaneous     breathing for 7 days following weaning will be considered to be successfully weaned from     mechanical ventilation.   "
202733|NCT00502502|"     Primary Objectives:        -  To determine the feasibility of a study that would describe changes of certain          circulating inflammatory cytokines (interleukin-1, 6, 8, 10, 12, and tumor necrosis          factor-alpha [TNF] and symptoms related to chemoradiation therapy (pre-therapy, during          therapy and up to 3 months post-therapy) among patients with lung, esophageal, gastric,          colorectal and anal cancer.        -  To determine the feasibility of studying neurocognitive function in patients with          non-small cell lung cancer (NSCLC) at presentation and during chemoradiation therapy to          determine the prevalence, severity, and pattern of cognitive symptoms.   "
202734|NCT00502515|"     The primary objective of this sudy is to assess the effect of two doses of SSR180575 on the     rate of regeneration of epidermal nerve fibers following denervation of the epidermal layer     with capsaicin in patients with diabetes mellitus and mild peripheral neuropathy. Secondary     objectives are to explore the efficacy of SSR180575 on clinical assessment, nerve function     measures and to assess the tolerability and safety of SSR180575. The treatment period is 6     months.   "
202735|NCT00502528|"     Background and Objective: Acute coronary syndrome is characterized by compromised blood flow     at the epicardial and microvascular levels. The aim of the present study is to investigate     the effect of ET-receptor blockade by BQ-123 on myocardial perfusion and infarct size as an     adjunct to PCI-reperfusion therapy in patients with STEMI.      Patients are randomized to receive periinterventional intravenous BQ-123 or placebo.   "
202736|NCT00502541|"     This was a multi-center, randomized, masked, parallel-group, controlled study in patients     with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of     care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the     safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of     patients with diabetic macular edema.   "
202737|NCT00502554|"     Investigation of photopheresis as new therapy regimen in patients with bronchiolitis     obliterans syndrome after lung transplantation in a controlled, randomized study   "
202739|NCT00502580|"     To obtain data to evaluate whether multispectral digital imaging can assist clinicians to     screen for premalignant lesions in the oral cavity. Our system will illuminate tissue with     monochromatic light to excite fluorescence, and polarized white light to generate     reflectance, exposing abnormalities for real time, clinical diagnosis.      Primary Objectives:        1. To compare fluorescence images of oral mucosa lesions, obtained at 350 nm, 380 nm, 400          nm, and 450 nm excitation, to standard white light images and pathologic analysis of          biopsied tissue.        2. To compare reflectance images of oral mucosa lesion, obtained using broadband polarized          light, to standard white light images and pathologic analysis of biopsied tissue.        3. To develop algorithms to discriminate between normal and abnormal tissue        4. To analyze images to determine which type of optical information (or combination          thereof) yields the most diagnostically useful data   "
203039|NCT00498797|"     The purpose of this study is to determine whether treatment with Zactima (vandetanib) in     combination with Docetaxel and Prednisolone is more effective than the standard Docetaxel and     Prednisolone alone for prostate cancer, in patients with Hormone refractory prostate cancer     who have not previously received chemotherapy.   "
202742|NCT00502619|"     The purpose of this research proposal is to conduct a feasibility study to determine the     viability a larger efficacy study of combined acupuncture treatments plus treadmill exercise     to decrease pain, facilitate exercise, and improve function in Veterans with chronic low back     pain (CLBP). To test this novel approach, subjects enrolled from a Veteran population at the     Veteran Affairs Maryland Health Care System (VAMHCS) will undergo acupuncture plus low     intensity treadmill walking exercise. Preliminary data regarding subject compliance,     self-report of function, pain control, ambulatory activity, and exercise capacity will be     collected to assess the response to this combined acupuncture/treadmill exercise protocol.     Additionally, this study will determine the viability of this combined treatment paradigm for     a larger study that will examine efficacy.   "
202743|NCT00502632|"     The purpose of this study is to determine whether intrapleural treatment with Dornase alfa     plus Urokinase improves clinical outcome compared to Urokinase alone in children with     complicated parapneumonic effusions   "
202744|NCT00503399|"     The objective of this study is to test the hypothesis that teriparatide is superior to the     active comparator in the change from baseline to 18 months of lumbar spine volumetric     trabecular bone mineral density (BMD) in males with glucocorticoid-induced osteoporosis.   "
202745|NCT00503412|"     Open, non-randomised, radiolabelled, single centre study with a total of six patients with     solid metastatic tumors to determine the rates and routes of elimination of 14C-AZD2171 and     its metabolites.   "
202746|NCT00503425|"     This single arm study will evaluate the safety and efficacy of MabThera in participants with     active rheumatoid arthritis who have had an inadequate response to prior treatment with     DMARDs and/or anti-TNF alpha agent. Participants will be treated with MabThera 1000     milligrams (mg) intravenously (IV) on days 1 and 15. Participants were followed every 8 weeks     to complete 24 weeks of follow-up. After completion of the Week 24 visit, the participants     were followed every 3 months for up to 18 months for an overall study duration of 24 months     (104 weeks). After week 36, eligible participants who achieve moderate or good response     according to the European League Against Rheumatism (EULAR) response criteria will receive     re-treatment with MabThera. Participants will receive concomitant treatment with DMARDs,     corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics throughout the     study period. The anticipated time on study treatment is 2 years, and the target sample size     is 200 participants.   "
202747|NCT00503438|"     This post market outcome study will look at the therapeutic results of the Salto Talaris     Anatomic ankle prosthesis. The study population will consist of patients who will undergo an     ankle arthroplasty procedure with a Salto Talaris ankle implant. An analysis will be     conducted of the results, complications and revisions of this prosthesis based on the     etiology for which the ankle arthroplasty was performed.   "
202748|NCT00503451|"     The primary purpose of this open-label study is to investigate the interaction of     ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid     tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in     patients with advanced solid tumors.   "
202749|NCT00503464|"     This project involves a comprehensive assessment of barriers to diabetes guidelines adherence     across 25 practices in the Crozer-Keystone primary care PBRN. A Barrier Assessment Tool (BAT)     will be validated to correlate with provider and practice adherence to diabetes care     guidelines. The network is part of the Crozer-Keystone Health System located in Delaware     County, Pennsylvania, in the southeast quadrant of the Philadelphia metropolitan region.   "
202750|NCT00503477|"     A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171     following single and multiple oral doses in patients in Japan with advanced solid     malignancies. In addition there will be an expanded cohort multi-centre study phase with     NSCLC patient and CRC patients   "
202751|NCT00503490|"     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which     has been particularly problematic to eradicate and been implicated as the major cause of     morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung     increases the local concentrations of antibiotic at the site of infection resulting in     improved antimicrobial effects compared to systemic administration. Bacterial resistance to     current aerosol antibiotic treatments indicate a need for improved therapies to treat CF     patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and     other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to     have antimicrobial effects on even the most resistant organisms and reduce the emergence of     resistant bacteria.   "
202752|NCT00503503|"     The objective of this surveillance is to determine the following items in all patients     receiving Enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset     (frequency, severity and other details) of adverse events, 3) factors considered to affect     the safety, and 4) the efficacy of Enbrel. Moreover, the onset (frequency, severity and other     details) of the followings will be key issues of this surveillance:Infection (tuberculosis,     opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor,     interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and     application site reactions.   "
202753|NCT00503516|"     The purpose of this study is to demonstrate the efficacy of megestrol acetate in the gain of     body weight in patients with primary or mixed Dementia with a weight loss.   "
202754|NCT00503529|"     The purpose of this study is to assess:        -  TBE antibody persistence 24, 34, 46 and 58 months (as applicable) after the first          booster TBE vaccination with FSME-IMMUN 0.5ml given in Study 223, by means of ELISA          (IMMUNOZYM FSME IgG) and Neutralization test (NT),        -  TBE antibody response to a second booster vaccination with FSME-IMMUN 0.5ml in the          present study, by means of ELISA and NT,        -  Safety of FSME-IMMUN 0.5ml after the second booster vaccination.   "
202755|NCT00503542|"     Many women present in primary care with vaginal complaints. The best way of managing these     complaints is unclear. This trial will test two different methods of managing patients with     vaginal complaints. This is a pilot trial.   "
202756|NCT00503555|"     The purpose of this study is the creation of a PBRN that will comprise primary care     providers, community health organizations, community advocates and a research core of two     academic institutions in order to study the healthcare needs of a rapidly growing immigrant     population.   "
202757|NCT00503568|"     RATIONALE: Vaccines made from a person's tumor cells may help the body build an effective     immune response to kill non-small cell lung cancer cells.      PURPOSE: This phase I trial is studying the effects of gp96-Ig vaccine therapy in treating     patients with stage III, stage IV, or relapsed non-small cell lung cancer treated with     first-line chemotherapy.   "
202758|NCT00503581|"     This randomized phase II trial is studying how well megestrol works in treating patients with     endometrial neoplasia or endometrial hyperplasia. Estrogen can cause the growth of     endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by     blocking the use of estrogen by the abnormal cells.   "
202759|NCT00503594|"     The purpose of this study is to evaluate two types of chemotherapy for primary central     nervous system lymphoma in the elderly (age older than 60) :        -  Methotrexate, procarbazine, vincristine and cytarabine        -  Methotrexate and temozolomide   "
202760|NCT00503607|"     This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA     approved bowel preparation in adult subjects undergoing colonoscopy.   "
202761|NCT00503620|"     Botulinum toxin injections are a common form of treatment for children with cerebral palsy to     help reduce muscle tightness and help them walk without resorting to surgery. While the     treatment is beneficial, it requires that the therapy be repeated every six months, which can     be costly and may eventually result in the therapy not being effective over time. The study     being conducted at Shriners Hospitals for Children, Philadelphia, will examine the effects of     botulinum toxin injections, not only on walking, but on the changes it causes in the muscle,     brain and spinal cord. The changes in the muscle, brain and spinal cord, called neuromuscular     plasticity, have not been extensively examined in response to botulinum toxin, and could     provide insight into how botulinum toxin works and how to make it more effective. This study     will focus on children with cerebral palsy between the ages of 4 and 12 years, with only one     leg involved and who would normally be receiving botulinum toxin injections of the lower leg     to help improve walking. The children will be asked to come into the hospital for a full day     before they receive the injection, and then again after four and twelve weeks to look at the     changes in the muscle, brain and spinal cord. This will involve recording them while they     walk, measurements of the muscle reflexes, and recording their brain activity while the move     their ankle (also known as functional magnetic resonance imaging or fMRI). A group of     children with typical development will also be asked to participate in the study to act as a     comparison group. The researchers believe that examining the changes in the muscles, brain     and spinal cord in response to the injection will aid in the understanding how better to use     botulinum toxin to achieve better or longer lasting changes.   "
202762|NCT00503633|"     The purpose of this study is to identify biological markers, including genes, associated with     sleep disturbance and other symptoms among people with HIV.   "
202763|NCT00503646|"     RATIONALE: Participating in a therapy program may enhance communication and intimacy between     men with prostate cancer and their partners.      PURPOSE: This randomized clinical trial is studying how well therapy enhances communication     and intimacy for men with early stage prostate cancer and for their partners.   "
202764|NCT00503659|"     This study is meant to compare two routine diagnostic approaches in patients with bronchial     asthma. Patients are challenged with methacholine in order to measure their bronchial     response. We compare the evaluation of the effects of incremental concentrations versus     incremental dosages.   "
202765|NCT00503672|"     We would like to quantify the amount and type of activity a typical pregnant woman engages in     and then compare the pregnancy outcomes of women with varying activity levels. To do this, we     will have women wear a device known as an accelerometer (that records activity by measuring     changes in voltage levels) at certain times in their pregnancies.   "
202766|NCT00503685|"     Patients with mCRC who have progressed on a prior Anti-EGFr regimen randomized to receive     IMC-A12 monotherapy or combination therapy with cetuximab to assess response, survival,     durations of response, safety and tolerability as well as pharmacodynamics of IMC-A12 and     cetuximab   "
202767|NCT00503698|"     This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.      The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on     survival (primary end-point; time to death and health related quality of life in adult     patients on chronic haemodialysis.   "
202768|NCT00503711|"     An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in     Chinese patients with advanced solid malignant tumors.   "
202769|NCT00503724|"     RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin in     treating young patients with refractory primary brain tumors.   "
202770|NCT00503737|"     The American Cancer Society and The Centers for Disease Control and Prevention in     collaboration with The National Colorectal Cancer Roundtable published How to Increase     Colorectal Cancer Screening rates in Practice: A Primary Care Clinician's Evidence-Based     Toolbox and Guide in 2005. This toolbox outlines evidence-based interventions aimed at     increasing colorectal cancer screening by primary care providers and their office staff. The     Toolbox contains the tools to design a multifaceted intervention to increase primary care     physician rates of colorectal cancer screening (CRCS). This is a pilot study to look at     implementing the toolbox and its affects.   "
202771|NCT00503750|"     This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor     2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with     trastuzumab before having breast surgery.   "
202772|NCT00503763|"     The aim of the study is to evaluate the effect of statin administration on the course of     progressive Smoldering Multiple Myeloma.   "
202798|NCT00504101|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as arsenic trioxide and melphalan,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving high-dose combination chemotherapy together with     bortezomib may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     given together with arsenic trioxide and melphalan in treating patients undergoing an     autologous stem cell transplant for multiple myeloma.   "
202773|NCT00503776|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by     chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation     therapy are more effective with or without amifostine in treating head and neck cancer.      PURPOSE: This randomized phase II trial is studying amifostine to see how well it works     compared with standard care in reducing side effects in patients undergoing chemotherapy and     radiation therapy for stage III or stage IV head and neck cancer.   "
202774|NCT00503789|"     Infants will be fed infant formula and stool characteristics assessed.   "
202775|NCT00503802|"     Obstructive sleep apnea occurs in 2-4% of middle age adults and results in significant     morbidity and mortality. The first line therapy is provision of continuous positive airway     pressure (CPAP) via a nasal mask chronically. Nasal resistance related to nasal turbinate     enlargement may compromise CPAP treatment. This randomized double-blind     sham-placebo-controlled trial tests the hypothesis that nasal turbinate reduction improves     the nasal passage, CPAP use, and sleep apnea quality of life in newly diagnosed sleep apnea     patients who are recommended CPAP therapy.   "
202776|NCT00503815|"     This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA     approved bowel preparation in adult subjects undergoing colonoscopy.   "
202777|NCT00503828|"     Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast     Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional     medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the     anti-inflammatory activity. Although NSAIDs are efficaciously in the treatment of     osteoarthritis,but the GI side effect is still concerned. In this study we aim to investigate     the efficacy and safety of D. Scandens Benth extract compared with Naproxen for therapy of     patients with knee osteoarthritis.   "
202778|NCT00503841|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This clinical trial is studying how well erlotinib works in treating women     undergoing surgery for stage I, stage II, or stage III breast cancer.   "
202779|NCT00503854|"     Primary Objectives:        -  To determine whether fatigue improves as patients are treated for febrile neutropenia          (Day #1, Day #2 and Day #6).      Secondary Objectives:        -  To identify clinical factors associated in cancer patients with low risk for outpatient          treatment of febrile neutropenia on either outpatient febrile neutropenia treatment          pathway presenting with moderate to severe fatigue. Moderate fatigue is defined as a          score of 4 through 6 on the Brief Fatigue Inventory and severe fatigue is defined as a          score of 7 through 10 on the Brief Fatigue Inventory.        -  To describe demographic information in cancer patients with low risk for outpatient          treatment of febrile neutropenia and fatigue while enrolled in either of two outpatient          febrile neutropenia treatment pathways.   "
202780|NCT00503867|"     The main purpose of this study is to determine the safety and toxicity of treatment with     SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma     (HCC). Other purposes of this study include assessment of the effect of treatment on overall     survival, the length of time it takes for the disease to worsen, if and how the treatment     affects the patient's quality of life, and if and how the cancer responds to the treatment.   "
202781|NCT00503880|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells     found in bone marrow or in peripheral blood and may help the immune system recover from the     side effects of chemotherapy. Giving clofarabine and cytarabine together with G-CSF may kill     more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and     to see how well it works when given together with cytarabine and G-CSF in treating patients     with myelodysplastic syndromes.   "
202782|NCT00503893|"     The goal of this clinical research study is to collect information and blood samples to try     to learn why some people develop cancers and tumors, why some families have more cancers than     others, and whether certain genes or regions of DNA (the genetic material of cells) affect a     person's risk of getting cancer.      This is an investigational study.      Up to 1500 patients and family members will take part in this study. All will be enrolled at     MD Anderson.   "
202783|NCT00503906|"     The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will     increase the progression-free survival (PFS) in patients with first line metastatic breast     cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with     definable metastatic disease, 6 or more months after primary treatment.   "
202829|NCT00504504|"     Primary Objective:      - To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD     combination chemotherapy.      ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.   "
202784|NCT00503919|"     The overall objective of this study is to identify potential improvements for a noninvasive     method of diagnosing dysplasia and neoplasia in the cervix using Multi-spectral Digital     Colposcopy (MDC), a device that uses fluorescence and reflectance spectroscopy to compare     images to histopathologic mapping of the cervical epithelium.      Primary Objective:      -To measure Multi-spectral Digital Colposcopy images in vivo of the cervix both before and     after acetic acid in a screening population.This is a second generation research device with     low significant risk for which we are studying MDC.      Secondary Objectives:        1. To evaluate the effect of the fading of acetic acid in the image contrast obtained over          time to see if this fading can predict the presence of any neoplasia.        2. To evaluate mapping the cervix so that software can reconstruct the cervical epithelial          map as evaluated by a Papanicolaou Smear to compare to routine colposcopic images as          well as those from the Multi-spectral Digital Colposcopy (MDC).   "
202799|NCT00504114|"     The purpose of this study is to use better magnetic resonance imaging (MRI) techniques to     examine the knee and the bony and soft tissue changes so as to better predict the progression     of osteoarthritis and acute knee injuries.   "
202800|NCT00504127|"     To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of     signs and symptoms of osteoarthritis   "
202785|NCT00503932|"     The primary objective of the Phase I portion of this study is to evaluate the safety of a     combination of capecitabine and proton therapy for patients with locally advanced or     recurrent rectal cancer. The maximum tolerated dose (MTD) will be determined in the Phase I     portion of this trial.      The primary objective of the Phase II portion of this study is to evaluate the local control     rate in patients treated with the above regimen at the MTD.      Secondary Objectives:        1. To evaluate local tumor response in patients treated with the above regimen.        2. To evaluate the relapse-free and overall survival in patients treated with the above          regimen.        3. To evaluate proton dosimetry in patients receiving this treatment.        4. To evaluate quality of life in patients receiving this therapy.   "
202786|NCT00503945|"     The aim of this study is to clarify the influence of obstructive sleep apnea syndrome on left     ventricular function using echocardiographic parameters including the myocardial performance     index (Tei-index), and to determine the short-term effects of nCPAP on them.   "
202787|NCT00503958|"     RATIONALE: Environmental exposure and genetic predisposition may affect the risk of     developing cancer later in life. Learning about genetic markers and the long-term effects of     environmental exposure may help the study of lung cancer in the future.      PURPOSE: This research study is looking at risk factors and genetic markers in healthy     participants and in patients with lung cancer.   "
202788|NCT00503971|"     This is an open label, non-randomized, sequential, phase I/II trial in patients with stage     IIIB or IV non-small cell lung cancer (NSCLC) with EGFR mutations after progression to     Erlotinib. The study will have two parts. The first part (phase I) will be a dose finding     (MTD) study to be implemented at three hospitals. The second part of the study (phase II)     will asses the safety and efficacy of the combination. In this second part (phase II)     patients will be treated with oral Erlotinib 150 mg P.O daily plus oral Vorinostat     administered according to the results of the phase I. The study endpoints to be evaluated     will include safety and response rate (RR) as primary endpoints and clinical benefit rate     (CBR), time to progression, time to response, response duration and progression free survival     as secondary endpoints. All the patients (phase I and II) will be treated until progression     disease, unacceptable toxicity or withdrawal of the consent, and will be treated at the     discretion of the principal investigator.   "
202789|NCT00503984|"     Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth     Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes.   "
202790|NCT00503997|"     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving pemetrexed together with oxaliplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving pemetrexed together with oxaliplatin     works in treating patients with locally advanced head and neck cancer.   "
202791|NCT00504010|"     Arnica in a topical gel formulation will be compared to a placebo to determine whether it     decreases muscle soreness following leg exercise when applied to the legs.   "
202792|NCT00504023|"     RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in     different ways and stop tumor cells from growing. Applying topical imiquimod to the vulva may     be an effective treatment for recurrent Paget's disease.      PURPOSE: This clinical trial is studying how well topical imiquimod works in treating     patients with recurrent Paget's disease of the vulva.   "
202793|NCT00504036|"     To demonstrate, during a prospective randomized medico-economic study, in morbidly obese     patients (BMI > 45 kg/m²) selected for a laparoscopic gastric by-pass that, in comparison to     usual care, a temporary intra-gastric balloon (6 months) decreases medical costs and     peri-operative morbidity.   "
202794|NCT00504049|"     Several methods exist to evaluate motor function in the child with cerebral palsy and are     used to assess the outcome of a clinical intervention. However, these scales are not directed     towards measuring the changes in muscle activity patterns that can result from the     intervention. For example, there are classification scales aimed at measuring motor function     and functional abilities, and indices of gait function. These scores, while providing a way     to quantify function and mechanics, do not directly measure muscle activation     characteristics. Therefore, these tests may be insensitive to how the intervention has     directly affected muscle function, which is usually the focus of the intervention (i.e.     botulinum toxin, functional electrical stimulation, dorsal rhizotomy). Muscle biopsies and     motor evoked potentials can provide information about the muscle activation characteristics,     however, they are invasive and there are concerns about using these techniques on the     pediatric population and/or the practicality of clinical implementation, especially since     they do not provide insight into how the muscle behaves during a functional task. One method     that can be used to provide insight into muscle activity in a non-invasive and clinically     meaningful manner is the use of surface electromyography (sEMG). Surface EMG is typically a     routine part of clinical assessment and the evaluation of motor impairment in CP. However,     the analysis of the data has been limited in most cases to examination of signal amplitude or     differences in muscle onset and offset timing.      The long-term goal of this research is to develop an analysis method for sEMG that can be     used during functional tasks for treatment planning, diagnostic, assessment purposes in CP.     This is to be accomplished through the use of the continuous wavelet transform (CWT). By     developing an assessment method based on muscle activity, it is believed that a clinically     viable measurement tool can be devised that will provide a level of insight into the effects     of an intervention on muscle pathophysiology that is not currently available. The first step     in progressing towards this long-term goal is to determine the variability and range of     expected time-frequency patterns that can be expressed in a given population (i.e., cerebral     palsy) during the execution of a meaningful task (gait), and relate the time-frequency     information back to more standard assessments   "
202795|NCT00504062|"     To investigate the effect and safety of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose     twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years     old in need for inhaled glucocorticosteroid treatment. To compare the efficacy of budesonide     Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks to that of fluticasone     Diskus® 50 μg/dose and 100 μg/dose twice daily for 6 week.   "
202796|NCT00504075|"     To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a     threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the     safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects     with chronic ITP for.   "
202797|NCT00504088|"     To compare the outcome of bypass surgery and plaque excision for treatment of critical limb     ischemia in the lower limbs   "
202801|NCT00504140|"     Primary Objectives:        1. To determine the efficacy of combining Interferon Alpha (IFN) with etoposide for the          treatment of relapsed osteosarcoma.        2. To determine if IFN alters the plasma pharmacokinetics of etoposide.        3. To determine the toxicities of IFN and etoposide when administered together.        4. To determine IFN blood levels following combination therapy.   "
202804|NCT00504179|"     The purpose of the study was to determine the effect on recovery after surgery of patients     who received a standardized daily protocol of osteopathic manipulative treatment.Patients     undergoing elective coronary artery bypass surgery were voluntarily enrolled in the study and     assigned to one of three groups.One group received a standardized daily treatment protocol     along with conventional care, another received daily similar placebo treatment with     conventional care, and a final group received only conventional post surgical care.The     research hypothesis was that daily treatment with osteopathic manipulative treatment would     reduce hospital stay and hasten recovery from surgery.Persons in the treatment group had     earlier discharge, and faster recovery of bowel function and basic mobility.   "
202805|NCT00504192|"     The role of systemic chemotherapy in advanced biliary tract cancer (BTC) is known to be very     limited although various single-agent or combination therapies had been tested. However,     there is a possibility that palliative chemotherapy induce prolong survival and improve     quality of life in advanced BTC based on several studies. A GERCOR study showed the promising     result of gemcitabine in combination with oxaliplatin as first line chemotherapy in advanced     BTC. Therefore, this phase II trial was planned to investigate efficacy and toxicity of     combination chemotherapy with gemcitabine and dose adjusted oxaliplatin in patients with     inoperable BTC in Korea.   "
202806|NCT00504205|"     RATIONALE: MP470 may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This clinical trial is studying the side effects and best dose of MP470 in treating     patients with unresectable or metastatic refractory solid tumor, Hodgkin's lymphoma, or     non-Hodgkin's lymphoma.   "
202807|NCT00504218|"     This study will determine the prevalence of endocrine-related side effects in children who     have been treated for cancer and establish a database and registry organized according to     cancer diagnosis, treatments and endocrine side effects. In children, the endocrine system,     which includes glands and hormones that help to control metabolism, growth, development and     reproduction, is particularly vulnerable to long-term side effects associated with cancer and     its treatments. The study will also serve to help train medical fellows, residents and     students in identifying and managing endocrine abnormalities in children who have been     diagnosed with and treated for cancer.      Children between 2 and 24 years of age who have been treated for a childhood cancer and have     been disease-free for at least 1 year may be eligible for this study.      All participants undergo the following procedures:        -  Review of cancer treatment record        -  Review of medical and family history        -  Blood draw for DNA studies        -  Physical examination and body measurements (height, weight, waist, body proportions)        -  Completion of child health questionnaires        -  Individualized screening and counseling program        -  Review of the following endocrine systems: growth, pituitary and hypothalamic function,          thyroid function, ovary and testicular function, bone health, risk of obesity and          diabetes      The following additional studies may be done, as clinically indicated:        -  Magnetic resonance imaging (MRI) of the brain        -  Thyroid, testicular or ovarian ultrasound        -  DEXA scan to measure bone density        -  Wrist x-ray to measure bone age        -  Blood tests        -  Urine pregnancy test for girls who are old enough to have menstrual periods        -  Stimulation testing (tests that involve giving medicine by mouth or in the vein and then          measuring blood levels of substances afterwards, such as oral glucose tolerance test,          arginine-clonidine growth hormone stimulation test, ACTH stimulation test, and          gonadotropin-releasing hormone stimulation test)      Children with endocrine abnormalities are offered standard treatments.   "
202808|NCT00504231|"     This randomized trial compared the immunogenicity of 60% dose intradermal (ID) influenza     vaccination to standard intramuscular (IM) vaccination of full-dose or 60% dose vaccine. Pre-     and postvaccination measurements in the hemagglutination inhibition antibody (HAI) titer were     compared. Participants who received reduced-dose vaccine were revaccinated with full-dose IM     vaccine.   "
202809|NCT00504244|"     This study is designed to explore the use of myfortic ® in patients with active lupus     erythematosus. Similar drugs in this class are increasingly used in organ transplantation and     in autoimmune diseases. With the established safety profile of myfortic ® in     allo-transplantation and the already existing data of mycophenolate mofetil in autoimmune     diseases, this study should help to demonstrate the beneficial effect of myfortic ® on lupus     activity. The aim of the study will be to show a decreased disease activity with myfortic ®     compared to standard maintenance therapy with azathioprine.   "
202810|NCT00504257|"     The purpose of this study is to evaluate the effectiveness of the combination of Avastin and     Docetaxel in the treatment of women with platinum sensitive recurrent epithelial ovarian     cancer within 12 months of platinum chemotherapy.   "
202811|NCT00504270|"     This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients     with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3     treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or     c)placebo. The anticipated time on study treatment is <3 months, and the target sample size     is <100 individuals.   "
202812|NCT00504283|"     An analgesia protocol for acute renal colic will lead to faster significant reductions in     pain than prior practice.   "
202813|NCT00504296|"     RATIONALE: SB939 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of SB939 in treating     patients with locally advanced or metastatic solid tumors.   "
202814|NCT00504309|"     The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of     an omega-3 fatty acid concentrate in a group of people who normally are not treated for high     lipids.   "
202815|NCT00504322|"     This study is a randomized, double-blinded assessment of biologic efficacy of AdcuCD40L. The     individuals enrolled in this study will be individuals with biopsy proven resectable     esophageal carcinoma. The dose of the AdcuCD40L vector (administered endoscopically directly     to the tumor) will be the highest tolerable dose (most likely 10^11 particle units)     determined from Weill-IRB protocol #0011004683 dose escalation study.   "
202816|NCT00504335|"     This trial is designed to evaluate the safety and pharmacokinetics of BIO 300 capsules when     administered orally to healthy male and female volunteers. BIO 300 is expected to be safe for     use starting at 500 mg.   "
202817|NCT00504348|"     The purpose of the study is to evaluate the efficacy and safety of the combination treatment     of tacrolimus and corticosteroid in polymyositis/dermatomyositis patients with interstitial     pneumonitis with comparison against corticosteroid-treated historical controls.   "
202818|NCT00504361|"     This is a research study where researchers are collecting blood to evaluate the genetic     characteristics of individuals with chronic lung diseases, including asthma, COPD (chronic     obstructive pulmonary disease), interstitial lung disease, cystic fibrosis, and lung cancer.     The investigators hope to be able to identify an association between a genetic make-up in the     blood samples and the risks of developing a particular lung disease, or severity of a lung     disease. The findings of this study might be important to develop future preventative methods     and potential treatments for the management of lung disease.   "
202819|NCT00504374|"     Primary Objectives:        -  Construct a prospective cohort of patients diagnosed with lung cancer and dispositioned          for treatment and collect information on symptoms and symptom treatments at baseline and          on follow-up.        -  Develop preliminary statistical models incorporating genetic data (which will be          obtained from an existing protocol, CPN 91-001, Margaret Spitz), disease-related          variables (e.g., stage of disease, location of tumor), clinical health status (e.g.,          performance status, comorbid conditions), and sociodemographic characteristics (e.g.,          age, sex, race) for predicting the risk of severe and persistent symptoms.      Analytical aim: To determine if symptoms (e.g., fatigue, depression, lack of appetite) will     differ in severity by IL-6 gene polymorphisms (-174G/C, -597G/A, -572G/C, -373An/Tn).      This study (NIH-CA109043, Reyes-Gibby, 2004-2009) builds upon an NIH-funded (NIH-CA55769,     Spitz, 2003-2008) study of the molecular epidemiology of lung cancer.   "
202820|NCT00504387|"     Oral burning can have a multitude of reasons. Recent neurophysiologic study results suggest     that a primary burning mouth disorder (BMD) may be a peripheral and/or a central neuropathic     disorder. The aim of this study is to first identify patients with a primary burning mouth     disorder by excluding other possible causes for oral burning. By means of qualitative and     quantitative sensory testing and a gustatory examination in the individual patient the     investigators want to find out whether neurosensory differences exist between patients with a     primary BMD and controls and whether gustatory and neurosensory deficits always coexist in     BMD-patients.   "
202821|NCT00504400|"     The purpose of this study is to investigate if a new drug called ranibizumab is effective to     treat a rare bilateral disease of the macula: type 2 idiopathic macular telangiectasia (type     2 IMT). 10 patients will receive monthly injections of the drug into one eye over a period of     one year.   "
202822|NCT00504413|"     The purpose of this study is to determine to what extent CYP2B6, CYP3A4, and MDR1     polymorphisms affect the metabolism of methadone.   "
202823|NCT00504426|"     The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily     inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to     osteoporosis.   "
202824|NCT00504439|"     To assess safety of SB-656933 following repeat dosing for 14 days.   "
202825|NCT00504452|"     The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given     every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral     regimens.   "
202826|NCT00504465|"     To compare sequential dinoprostone and oxytocin for induction of labor at term with intact     membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings     from smaller trials and add to data on fetal safety.   "
202827|NCT00504478|"     The purpose of this study is to examine the anti inflammatory effect of high complex     carbohydrate diet, supplemented by omega-3 fatty acids.   "
202828|NCT00504491|"     Since there is no standard rescue therapy for refractory CLL or relapsed to the purine     analogous, our target is to carry out a rescue therapy combining several chemotherapy agents     (CHOP) adding the synergistic effect of Rituximab in order to act against tumour-like CLL     forms, with assessable size lymph nodes. Afterwards, based in other studies, we shall study     the role of Alemtuzumab as drug for consolidation or improvement of responses obtained with     the initial therapy (CHOP-R), acting by cleaning from peripheral blood and bone marrow the     CLL lymphocytes that may have had remain as residual after chemotherapy induction therapy.     More precisely, the addition of Alemtuzumab as maintenance treatment would increase the     complete responses with negative residual disease number and may prolong the duration of the     response. For this, it is necessary to have not only an adequate and rigorous clinical     follow-up but also biological, i.e. being able to analyze minimal residual disease by     molecular biology techniques. This is the reason of writing this phase II clinical trial     protocol.   "
202830|NCT00504517|"     We would like to better understand how different educational strategies may influence the     practice of family medicine. More specifically, we are interested in participant satisfaction     with the educational program, participant retainment in this career, and to see if the     curricular change better prepares participants for contemporary clinical practice.   "
202831|NCT00504530|"     This study was designed to obtain pilot clinical evidence of the efficacy, safety and     acceptability of r-hLIF administered during the luteal phase after IVF/intra-cytoplasmic     sperm injection (ICSI) and ET for improving embryo implantation in infertile women with a     history of at least three implantation failures following ART. Based on LIF expression     patterns and experimental data from animal research a role of LIF in embryo implantation is     anticipated.   "
202832|NCT00504543|"     This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free     (calcineurin inhibitor) regimen in renal transplant recipients.   "
202833|NCT00504556|"     This study is to assess the safety of a potential new drug DU-176b for the prevention of     stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation     (AF). The duration is 3 months of treatment and a 30 day follow-up visit.   "
202834|NCT00504582|"     Primary Objective:        -  To determine whether the use of a fibrin sealant applied to axillary soft tissues          following node dissection can result in earlier drain removal.      Secondary Objectives:        -  To determine the postoperative morbidity rate using fibrin sealant following axillary          node dissection.        -  To assess patient-valuation of outcome by performing a cost-benefit analysis using a          willingness-to-pay model.        -  To determine if serum levels, lymphatic fluids level, or cutaneous expression of          vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C          (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3)          correlates with nodal tumor burden or development of lymphedema in patients with          melanoma.   "
202835|NCT00504595|"     This study was intended to assess the safety, efficacy, and response to treatment using the     American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) and to     investigate a potential biomarker profile in adult patients with established rheumatoid     arthritis   "
203040|NCT00498810|"     To compare the complete repair of the abdominal wall at the level of the former incision with     only a partial repair at the level of the hernia in patients with an incisional hernia after     median laparotomy in a prospective randomized trial.   "
202836|NCT00504608|"     The primary objective of the study was to provide further clinical and statistical evidence     of the efficacy of r-hLIF, in comparison with placebo, administered during the luteal phase     after IVF and ET for improving embryo implantation in infertile women with a history of at     least 2 implantation failures following transfer of fresh embryos. The secondary objective of     the study was to assess the safety profile of r-hLIF in the proposed indication.   "
202837|NCT00504621|"     A number of studies have shown that the quality of life of two common interstitial lung     diseases (ild), sarcoidosis and pulmonary fibrosis patients, is impaired and that fatigue is     a substantial problem for those patients. Furthermore, breathlessness is an additional major     problem in pulmonary fibrosis. In the field of cardiovascular disease and breast cancer,     personality factors have shown to play a role in patient's morbidity, mortality, quality of     life, fatigue, depressive symptoms, and one study showed a predictive role of personality     factors in health care consumption. No studies examining personality factors have been     performed in sarcoidosis or pulmonary fibrosis. Therefore, the aim of the present study is to     examine the role of personality factors as predictors of fatigue, quality of life, prognosis,     and health care consumption in sarcoidosis and pulmonary fibrosis. In this study a number of     possible moderators, such as social support, will also be examined, aiming to get a full     picture of the relationship between the various factors examined. Known and new sarcoidosis     and pulmonary fibrosis patients (inclusion period 1 year) of ild care team of the outpatient     clinic of the department of Respiratory Medicine of the University Hospital Maastricht will     be asked to participate through completing questionnaires at baseline and every six months     for 18 months, and allowing the researchers access to their medical records for the purpose     of this study.   "
202838|NCT00504634|"     Primary Objective:      1. To determine the antimyeloma effect of bortezomib after allogeneic transplantation for     patients with multiple myeloma.      Secondary Objective      1. To determine the toxicity profile of bortezomib in patients with multiple myeloma     undergoing allogeneic progenitor cell transplantation.   "
202839|NCT00504647|"     Hypertrophic Cardiomyopathy is an inherited condition characterized by thickening     (hypertrophy) of the heart muscle. Many patients who have this condition have a reduced     ability to exercise because of breatlessness, which can in some cases be severe. This appears     in most cases to be due to an impairment of the filling of the heart, especially on exercise     this limits the amount of blood the heart is able to pump. Several factors may contribute to     this slow filling of the heart, including (1) The heart contracts and relaxes in an     incoordinate way (called 'dyssynchrony') which is inefficient, and (2) The filling of the     main pumping chamber (the left ventricle) may be impeded by high pressure in the other     ventricle(the right ventricle)- in other words the left ventricle is 'squashed' by the right     ventricle. This is known as diastolic ventricular interaction.      Although drugs can improve the filling of the heart and relieve symptoms, some patients     remain very symptomatic despite these drugs.      The mechanisms responsible for the filling abnormality in patients with Hypertrophic     Cardiomyopathy are similar to those seen in the much more common condition known as Heart     Failure. A special type of pacemaker technique called 'Biventricular Pacing' has been shown     to markedly improve symtoms in patients with heart failure. This form of pacing has been     shown to improve both 'dyssynchrony' ( incoordination) and 'ventricular interaction'     (squashed left heart) in patients with Heart Failure.      We propose that Biventricular pacing may similarly improve these abnormalities in patients     with Hypertrophic Cardiomyopathy, resulting in an improvement of symptoms. The study will     focus on patients with the condition who have severe symtoms despite being on optimal     currently available drug therapy.   "
202849|NCT00504777|"     This single arm study will assess the safety and efficacy of MabThera in combination with     methotrexate in patients with rheumatoid arthritis who have had an inadequate response or     intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on     days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with     methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study     treatment is 3-12 months, and the target sample size is <100 individuals.   "
202840|NCT00504660|"     The goal of this clinical research study is to learn if the combination of 6-Thioguanine,     Xeloda (capecitabine), and Celebrex (celecoxib) with Temodar (temozolomide) or Lomustine     (CCNU) is effective in the treatment of recurrent or progressive anaplastic glioma or     glioblastoma multiforme in patients who have failed previous treatments. The safety of these     combination treatment will also be studied.      Objectives:      1.1 To determine the efficacy, as measured by 12 month progression-free survival, of     TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed by CAPECITABINE and CELECOXIB in the     treatment of patients with recurrent and/or progressive anaplastic gliomas or glioblastoma     multiforme.      1.2 To determine the long-term toxicity of TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed     by CAPECITABINE and CELECOXIB in recurrent anaplastic glioma or glioblastoma multiforme     patients treated in this manner.      1.3 To determine the clinical relevance of genetic subtyping tumors as a predictor of     response to this chemotherapy and long term survival   "
202841|NCT00504673|"     This trial is conducted in Europe. The purpose of the trial is to investigate the effect of     insulin detemir on weight change in overweight and obese patients with type 2 diabetes.   "
202842|NCT00504686|"     Recently a clinical prediction rule (CPR) has been developed that identifies patients with     neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust     manipulation and an active range of motion exercise. Although the initial predictor variables     identified during the development of a thoracic spine manipulation CPR seem to have adequate     face validity, there is no guarantee that these factors will persist in a different group of     patients, even ones with similar characteristics as those used in the initial exploratory     study. The purpose of this follow-up study in which patients will be randomly assigned to     receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic     exercise alone will be to investigate the validity of the previously developed CPR. If the     CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine     thrust manipulation should experience improved outcomes compared to patients who are negative     on the CPR and receive thoracic spine manipulation, and compared to patients who are positive     on the CPR but receive the intervention believed to be effective for another subgroup of     patients with neck pain.   "
202843|NCT00504699|"     Breast cancer patients are commonly treated with drugs that eggs present in the ovary and may     reduce their chance for getting pregnant. Their fertility can be preserved by stimulating     their ovaries, collecting multiple eggs, fertilize them in the lab and freeze them. Ovarian     stimulation increase their estrogen levels in blood.this may stimulate their cancer and     increase chance for recurrence. If a medicine that prevent estrogen rise is used (letrozole),     this may increase the safety of stimulation. In this study we compared ovarian stimulation in     breast cancer patients using letrozole with those who did not undergo stimulation and showed     that there is no increase risk for recurrence after a median follow up of 2 years   "
202844|NCT00504712|"     There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels     in men. Testosterone treatment has shown beneficial effects on blood sugar control and     obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen     on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels).     Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that     testosterone will have beneficial effects on peripheral vascualr disease in men with low     serum testosterone and type 2 diabetes.   "
202845|NCT00504725|"     The primary aim of the study is to demonstrate a reduction in circulating interleukin 6     levels at 4 and 24 hours after completion of lobectomy (either VATS or open). The null     hypothesis (H0) is thus that there is no difference in circulating interleukin 6 levels when     patients are given either ketamine or placebo (0.9% saline in equivalent volume). The     alternative (two tailed) hypothesis (HA) if the null is disproved is that ketamine leads to     significantly different levels of interleukin 6 at 4 and 24 hours after completion of     surgery. We plan to randomize 40 patients to receive either ketamine or placebo, in a block     of 4 randomization design stratified by whether surgery is performed by VATS or open     lobectomy.   "
202846|NCT00504738|"     The purpose of this protocol is to obtain biologic samples from the blood and lungs from     patients with lung diseases in order to study the causes and indications of these disorders,     learn how these lung disease manifest and progress, and how the lung disease can be treated.   "
202847|NCT00504751|"     Objectives      The primary objective of this study is to:      • determine the complete and partial response rates and the toxicity profile of bortezomib     (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus     rituximab (i.e. VIPER) to patients with relapsed or refractory diffuse large B-cell     non-Hodgkin's lymphoma      The secondary objectives of this study are to:        -  assess event free survival and overall survival        -  assess conversion of chemo-resistant to chemo-sensitive disease        -  assess the ability to collect stem cells from patients treated with salvage VIPER who          then undergo autologous stem cell transplantation        -  perform correlative studies on pre-treatment tumor biopsy specimens; analyses will          include the assessment of immunohistochemical expression patterns (germinal center B          cell vs. activated B cell) and NF-κB activity   "
202848|NCT00504764|"     Summary Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB     M3/M3v), by the specific translocation t(15;17) and its molecular correlates (PML/RARa and     RARa/PML). Thereby it can be separated from all other forms of acute leukemia.      By all-trans retinoic acid in combination with chemotherapy cure rates of 70 to 80% can be     reached. On average, about 10% of patients still die in the early phase of the treatment and     about 20 to 30% relapse. Molecular monitoring of the minimal residual disease (MRD) by     qualitative nested RT-PCR and quantitative REAL-time PCR of PML/RARa allows to follow the     individual kinetics of MRD and to identify patients with an imminent hematological relapse.      A standardized treatment for patients with relapsed APL has not yet been established. With     arsenic trioxide (ATO) monotherapy remission rates over 80% were achieved and long-lasting     molecular remissions are described. The drug was mostly well tolerated. ATO exerts a dose     dependent dual effect on APL blasts, apoptosis in higher and partial differentiation in lower     concentrations. ATO was also successfully administered before allogeneic and autologous     transplantation. ATO is approved for the treatment of relapsed and refractory APL in Europe     and in the USA.      After remission induction, there are several options for postremission therapy Previous     studies shows that risk of relapse is higher in patients treated with ATO postremission in     monotherapy , than in other that receive ATO plus chemotherapy or transplantation (TPH).     Also, compared with chemotherapy, ATO induction and consolidation has a favorable impact in     posterior response to transplantation. It is due to a low toxicity or a best quality of     remission to TPH. It seems better, for these reasons, the intensification with TPH     (autologous or allogenic) in patients with relapsed APL treated with ATO. For another hand,     patients no candidates to TPH can be treated with ATO combined with other active agents in     APL, as ATRA, anthracyclines o Mylotarg   "
202850|NCT00504790|"     This is a Phase I, open-label, first time in human study of GSK923295, in adult subjects with     cancers that do not respond to standard therapy. This study will be conducted in two stages;     a dose-escalation stage (Stage 1) and an expansion cohort stage (Stage 2).   "
202851|NCT00504803|"     Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host     Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative     Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study   "
202852|NCT00504816|"     The purpose of this research study is to demonstrate a lack of effect of multiple doses of     GSK189075 on the PK of an oral contraceptive pill in healthy female subjects. To estimate the     effects of GSK189075 on hormonal levels and on birth control.   "
202853|NCT00504829|"     The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a     combination of atorvastatin and fenofibrate.   "
202854|NCT00504842|"     This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate     the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and     ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in     subjects with acute ischemic stroke.   "
202855|NCT00504855|"     The purpose of this study is to compare waterproof cast padding material to standard     cotton/poly-cotton cast padding material to the presence or absence of cast sores of the     heel.   "
202856|NCT00504881|"     This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo     in subjects suffering from Epilepsy.   "
202891|NCT00505362|"     Suture reapproximation of the rectus muscles at primary cesarean delivery is a common     practice about which there are no data. Some Obstetricians believe that suture     reapproximation of the rectus muscles increases post-operative pain, and it may decrease     adhesions, yet there are no published data to support or refute these claims. The purpose of     this study is to assess the effect of rectus muscle reapproximation at cesarean delivery and     post-operative pain. We also plan to assess the impact of rectus muscle closure on adhesions     as seen at repeat cesarean delivery.   "
202857|NCT00504894|"     This study involves 90 healthy volunteers aged between 18 and 50 recruited from the general     community. It involves doing a set of simple memory tests while inside a fMRI machine. The     subject is given a very low dose of an anesthetic drug intravenously while in the scanner.     The subject then sees a sequence of pictures on a screen, and presses a button if they     remember seeing the picture before. While this is happening, the scanner will be capturing     images that tell us what parts of the brain are active. Hypothesis: patterns of hippocampal     and amygdala activation during the encoding and retrieval of memory,as measured by fMRI, will     be altered by intravenous anesthetics such that suppression of hippocampal and amygdala     activities will be dissociable. This dissociation pattern will be different between the drugs     propofol and thiopental.   "
202858|NCT00504907|"     This is a placebo-controlled, double-blind, randomised, single dose escalation Phase I     clinical trial to determine the safety and tolerability of BTA9881 administered orally to     healthy subjects   "
202859|NCT00504920|"     Primary Objective:      1. To assess the self-reported symptoms and the plasma cytokine levels of AML/MDS patients     pretransplantation and posttransplantation with allogeneic blood and marrow in order to     identify changes in symptoms (or symptom clusters) and changes in cytokines that may be     related to the conditioning regimen and/or to the development of GVHD during the 100 days     posttransplant.      Based on the current literature, both animal and human research, in this study we hypothesize     that increases in TNF alpha to be associated with poor appetite, sleep disturbance and     fatigue, but not with increases in pain, depression and numbness.   "
202860|NCT00504933|"     The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg,     compared to Cetirizine and placebo for the treatment of seasonal allergic rhinitis.   "
202861|NCT00504946|"     There is mounting evidence that successful allergen immunotherapy (SIT) functions through the     induction of different subset of Treg including Foxp3 positive cells, therefore additional     strategies to enhance this property are highly attractive. Based on previous findings we     assumed that combine allergen immunotherapy with non-specific treatments such as     glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced     allergen tolerance induction and improved clinical effectiveness of allergen-specific     immunotherapy   "
202862|NCT00504959|"     This extension study will investigate the long-term safety and tolerability of multiple     intravitreal injections of ranibizumab administered to patients with subfoveal choroidal     neovascularization secondary to age-related macular degeneration who have been previously     treated in either of the two ongoing ranibizumab studies CRFB002A2302 (EXCITE) or     CRFB002A2303 (SUSTAIN   "
202863|NCT00504972|"     Previous experience with antibody therapy in both NHL and CLL warrants further exploration of     new antibody treatments for these diseases.      Immunomedics has developed hLL1 (previously designated EPB-1), which is a CDR-grafted, fully     humanized monoclonal antibody specifically targeting CD74.38 The human IgG1 backbone for hLL1     is the same as hLL2 (epratuzumab), a monoclonal antibody whose safety has been demonstrated     in clinical trials of patients with B-cell malignancies and autoimmune disorders.      This is a Phase I, open-label, study conducted in patients with recurrent non-Hodgkin's     lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who have progressed after at least one     prior standard treatment. All patients will receive hLL1 administered intravenously once     daily Monday through Friday of each of 2 consecutive weeks (10 total doses.) Patients will be     assigned to a cohort for hLL1 treatment dose assignment (escalating doses of hLL1 per     statistical plan) in order to determine the maximum tolerated dose (MTD) for this     administration schedule.   "
202864|NCT00504985|"     1. To describe fatigue severity and its related symptom clusters in cancer patients who are          seeking emergency care for fever, pain, shortness of breath, or cancer therapy-related          gastrointestinal toxicities.        2. To describe inflammatory cytokine profiles in cancer patients who are seeking emergency          care for fever, pain, shortness of breath, or cancer therapy-related gastrointestinal          toxicities.        3. To determine the type of cytokines that are associated with fatigue severity in cancer          patients, with or without cancer treatment, in the early phase of infection, as well as          in patients with pain, shortness of breath, or cancer therapy-related gastrointestinal          toxicities.   "
202865|NCT00504998|"     The goal of the adaptive trial design is to determine the over-all safety of escalating doses     of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the     significant clinical benefits required to support a Phase II registration protocol.   "
202902|NCT00505505|"     Strict glycemic control improves mortality and morbidity of patients admitted to the     postoperative intensive care unit (ICU). The investigators would like to know if this therapy     could improve the long term neurologic and cognitive outcomes of patients treated for acute     subarachnoid hemorrhage with either a surgical or intravascular approach.   "
202866|NCT00505011|"     Cigarette smoking is a well-recognized risk factor of Graves’ disease and, particularly,     Graves’ ophthalmopathy. Hence, germline polymorphisms of detoxification genes and genes     belonging to the major DNA repair/apoptosis pathways might have an important role in disease     susceptibility. In addition, as some of these genes are regulated by thyroid hormones, they     could affect the outcome of these patients. Our objective was to assess the influence of the     GST, CYP and TP53 gene polymorphisms in the risk of Graves' disease and its outcome.   "
202867|NCT00505024|"     To test the effectiveness of the interactive voice response telephone system with a     triage/feedback component that incorporates timely symptom assessment, feedback to     physicians, critical treatment guidelines for managing selected symptoms (distress, sleep     disturbance, shortness of breath, constipation, and pain) in a cohort of cancer patients     during the first month post-thoracic surgery.      This interactive voice response system (IVR) will be evaluated in a randomized clinical trial     with an intervention group (IVR symptom assessment with triage) and a control group (IVR     symptom assessment only).      We hypotheses that:        1. Patients in the MDASI-IVR plus triage group will have less symptom burden (less symptom          severity, less symptom related interference, and better satisfaction of symptom control,          better physical and emotional well-being) over the month of the trial compared to the          control group.        2. Patients in the MDASI-IVR plus triage group will have more frequent documentation of          symptom management in line with treatment guidelines compared to the control group.   "
202868|NCT00505037|"     To evaluate the superiority to placebo, dose-responsibility and safety.   "
202869|NCT00505050|"     Recent meta-analysis reported reduction in mortality and hospitalization of HF     patients.However, important issues in DMP for HF remain to be resolved. DMP are not     homogeneous concerning methodology and in general included only elderly patients; most were     tested in high-risk HF patients discharged from hospital; quality of life results are     controversial; few reports included long-term results; some protocols had limited enrollment     of screened patients, and it was suggested that could be less effective when patients are     already followed by HF specialist.Improved survival was associated with cardiologist care as     well with multidisciplinary teams providing specialized follow-up.Whether both together could     benefits HF is not well defined. Also, no studies reported the long-term effects of a cyclic     repetitive reeducation program.We tested whether a DMP that consisted of a long-term     repetitive education program associated with a telephone monitoring could benefit HF     outpatients in usual ambulatory care already under care of cardiologist with experience in HF   "
202870|NCT00505063|"     This study will look at your body's response to the new immunizations. We want to see how     well they will protect you. Immunization is the same as vaccination. Our goal is to protect     you as much as we can. We do not want you to have the measles, mumps, or whooping cough. We     are doing the study because there is no standard way to re-immunize people after cancer     treatments.   "
202871|NCT00505076|"     Patients with schizophrenia are characterized by a broad range of neurocognitive     abnormalities. These include impairments in attention, including abnormalities in sensory     gating; executive function; visual and verbal learning and memory; working memory; processing     speed; and social cognition (Nuechterlein et al, 2004). These impairments are major     determinants of poor functional outcome in patients with schizophrenia (Green, 1996; Green et     al, 2004). Conventional antipsychotics have limited effects on these impairments. Second     generation antipsychotics may have modest benefits for cognitive function, but whether this     represents a direct cognitive enhancing effect has not been established. Regardless, patients     continue to exhibit pronounced cognitive impairments despite adequate second generation     antipsychotic treatment. Adjunctive pharmacotherapy may offer a viable approach for the     treatment of cognitive impairments. Adjunctive agents can be used to modulate specific     neurotransmitter systems that are hypothesized to be involved in the pharmacology of     cognitive functions.      The standard of care for schizophrenia is antipsychotic medications to treat psychotic     symptoms. However, cognitive impairments remain and these impairments have been found to be     significantly associated with the poor psychosocial function observed in patients with     schizophrenia. There is a considerable preclinical rationale for the use of drugs that act at     the Gamma-amino-buyric acid (GABA) α2 subunit as adjunctive treatments to target cognitive     impairments. MK-0777 GEM (Merck-0777 Gel Extrusion Module) formulation provides an     opportunity to directly test this mechanism.      The purpose of the proposed study is to examine the efficacy and safety of two doses of MK     (Merck) -0777 GEM, 3 mg BID (twice daily) and 8 mg BID (twice daily), in the treatment of     cognitive impairments in patients with schizophrenia. Secondary goals are to determine     whether MK-0777 has beneficial effects on measures of functional capacity and patient     self-report of cognitive function.   "
202872|NCT00505089|"     This study will investigate the pharmacokinetic (PK) / total IL-1beta pharmacodynamic (PD)     relationship in joint fluids of patients with rheumatoid arthritis (RA) treated with     different doses of ACZ885 and to evaluate the impact of the subcutaneous (s.c.) versus     intravenous (i.v.) route of administration.   "
202873|NCT00505102|"     The purpose of this study is to verify whether the reduction of cyclosporine dosages     associated with Everolimus administration may improve renal function as compared to patients     maintained on standard immunosuppressive therapy   "
202874|NCT00505115|"     The aim of this study is to identify the protein secretion and consumption profile of the     human blastocyst (secretome) and the implanted blastocyst (implantome) using the protein     array technology.   "
202875|NCT00505128|"     Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis:     a prospective multicenter randomized controlled study.   "
202876|NCT00505141|"     The Environmental Protection Agency has recognized that organophosphorus pesticides require     close regulation and continued monitoring for human health effects and some (e.g     chlorpyrifos) have been phased-out from the consumer market due to the special risk that it     posed for children. There is growing evidence in support of the association between pesticide     exposure and childhood leukemia. Studies of pesticides and their association with childhood     cancer have been limited by study designs, self-reporting and lack of biological     measurements. While several large studies in California found little evidence of an     association between agricultural pesticide use and childhood leukemia, these results are in     contrast with the associations observed with household exposures to pesticides. The real     association may depend on timing of exposure, type of pesticide, dose and pathway of     exposure. Furthermore, some persons may be more susceptible to the effects of specific     pesticides due to inherited mutations in their detoxification pathways.      We are conducting a pilot study to test the hypothesis that environmental exposure to     pesticides in pregnancy or during the neonatal period, together with genetic susceptibility     may lead to childhood ALL or brain cancer. The study is a multicenter, case-control study,     based on collaboration between clinical researchers and basic science research to evaluate     the risk for childhood cancer in relation to measured levels of pesticides (and their     metabolites) and genetic polymorphisms. Biomarkers will be used to examine the risks of     chronic low-dose exposures, and to characterize relationships between specific pesticides,     childhood cancer and genetic susceptibility.      Hypothesis: Interaction between environmental factors (pesticides) and maternal or child     genetic polymorphisms may lead to childhood cancer.   "
202877|NCT00505154|"     The purpose of this study is to examine the the effect of the HMG-CoA reductase inhibitor     Rosuvastatin on left ventricular remodeling in patients with dilated cardiomyopathy.   "
202878|NCT00505167|"     It is well known that in the brain of the patients with Alzheimer's disease there is a     glutamatergic hyperstimulation leading to neuronal death. Memantine is a low affinity     antagonist of NMDA glutamate receptors. The use of this drug in the early phases of the     disease could provide neuroprotective effects and delay of progression. The effects of     memantine should be compared to those of donepezil, which is the most prescribed     anticholinesterase drug.   "
202879|NCT00505180|"     The purpose of this study is to prospectively identify blood markers that identify chronic     hemodialysis patients at risk for early (<90 days) and late (>= 1 year) mortality   "
202880|NCT00505219|"     The purpose of this study is to determine if Ixmyelocel-T grafting with demineralized bone     matrix bound in autologous plasma after core decompression surgery is superior to core     decompression with demineralized bone matrix bound in autologous plasma in preventing     progression of osteonecrosis to a more severe disease stage (Stage II to III or higher) from     the time of surgery until 24 months later, in patients with University of Pennsylvania     (UPenn) Stage IIB or C disease at diagnosis.   "
202892|NCT00505375|"     The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in     individuals with new onset T1DM will improve insulin secretion (C-peptide production)     compared to placebo.   "
202893|NCT00505388|"     This patient follow-up programme was designed to describe the extent of Symbicort use in     patients prescribed Symbicort as maintenance and reliever therapy in routine clinical     practice in comparison with the already documented use of Symbicort as maintenance and     reliever therapy in clinical therapies   "
202881|NCT00505232|"     Mantle Cell Lymphoma (MCL) is a malignancy with a poor response to treatment and with a     median survival of 2- 4 years since diagnosis. Although histology is similar to that of an     indolent lymphoma, MCL is currently considered an aggressive tumour. Few prospective     therapeutic trials have been reported in MCL, and results are difficult to interpret due to     treatment heterogeneity. It is known that standard chemotherapy for other clinically     aggressive lymphomas yields poor results. Recently, better results have been communicated     with intense induction chemotherapy treatments or consolidating the response with high dose     chemotherapy with stem cell support. Keeping in mind these considerations, we will use and     intensive induction treatment with Hyper-CVAD/MTX-AraC associated with anti-CD20 in order to     increase the overall response rate followed by consolidation treatment with Ibritumomab     -tiuxetan (Zevalin) with the aim of eradicate the minimal residual disease, responsible of     relapse.   "
202882|NCT00505245|"     The purpose of this study is to try to learn more about common symptoms that may occur in     patients due to cancer and its treatment. We also want to learn more about the impact of     symptoms on your quality of life. Another goal is to learn how to better measure symptoms     systematically when caring for patients.   "
202883|NCT00505258|"     The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a     comparator in hospitalized patients with bacteremia.   "
202884|NCT00505271|"     The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to     determine the optimal dosing regimen for Rexin-G that would document the significant clinical     benefits required to support a Phase II registration protocol for recurrent or metastatic     breast cancer.   "
202885|NCT00505284|"     The purpose of this study is to determine the efficacy and safety of Perampanel in patients     with painful diabetic neuropathy.   "
202886|NCT00505297|"     In order to design future disease modifying osteoarthritis drug (DMOAD) proof of concept     studies, this study is being conducted to assess magnetic resonance imaging (MRI)     measurements of cartilage morphology and glycosaminoglycan (GAG) content as it relates to the     progression of disease in subjects with potentially rapidly progressing OA. The subject     population is selected to have higher likelihood of having rapidly progressing OA (i.e., a     more rapid joint space narrowing (JSN) compared to general knee OA population and thus, may     be more likely to have changes in GAG content and/or cartilage volume. The results of this     study may provide a reasonable means to assess DMOAD activity of drugs in development. The     non-OA controls are included to determine the rate of change for subjects of similar age.     Ideally, results of this study will identify reliable methods for delayed Gadolinium Enhanced     MRI of cartilage (dGEMRIC) and MRI cartilage assessment that correlate with OA disease     progression as compared to x-ray changes.   "
202887|NCT00505310|"     The proposed study will assess the psychological and physiological benefits of an emotional     expression intervention in patients with renal cancer. Patients will be randomly assigned to     an emotional expression writing group or to a neutral writing group. This study will also     evaluate the extent to which psychosocial factors mediate the intervention program and     predict patients' recovery and adjustment to treatment. Potential mediators include level of     cognitive processing, social networks/interactions, and sense of coherence and ability to     find meaning in the illness experience.      Specific objectives of the proposed research are:        -  To evaluate an emotional expression intervention in patients with renal cancer.          Researchers will determine the extent to which an emotional expression writing-based          intervention enhances adjustment during the first 12 months following diagnosis and          treatment. Dimensions of adjustment will be assessed by examining indices of QOL, mental          health, and stress (subjective symptoms of distress, perceived stress, and mood).        -  To determine the effects of an emotional expression writing-based intervention on immune          function. The immune measures assessed in this study will include both general and          autologous tumor-specific immune responses including cytotoxicity to K562 target cells;          cytotoxicity to autologous tumor target cells; and functional assessment of type-1 and          type-2 cytokines using autologous tumor and polyclonal stimulants.        -  To identify the psychosocial processes underlying the efficacy of the intervention.   "
202888|NCT00505323|"     Dystonia is a neurological movement disorder in which sustained muscle contractions cause     twisting and repetitive movements or abnormal postures. This disease is very heterogeneous     and can have many causes. Current treatments (drugs, pallidal stimulation) improve primary     generalized dystonias; however they are ineffective for focal dystonias following brain     damage.      Cortex stimulation is a present and effective technique used in the treatment of chronic pain     and could represent an interesting strategy to treat focal dystonias. This is the aim of the     present study.   "
202903|NCT00505518|"     The current use of telepsychiatry, or psychiatric care using videoconferencing, is very     limited. The present study investigates the use of this method with a depressed Chinese     American population in a nursing home. It is believed that this population can benefit from     telepsychiatric treatment when used in collaboration with the primary care they receive in     the nursing home.   "
202904|NCT00505531|"     The Massachusetts General Hospital Center for Translational Pain Research is conducting a     research study to see if Ultram ER, an FDA-approved pain medication, would be helpful in     providing pain relief in subjects whose chronic pain is not well controlled on narcotic pain     medicine.   "
202889|NCT00505336|"     To investigate whether the medicines eplerenone or atorvastatin have a favourable effect on     diastolic heart failure.      Eplerenone is a drug that has been shown to be beneficial in Chronic Heart Failure due to     pump failure. It can increase life expectancy and improve symptoms in these patients. It is     not known whether or not eplerenone might be beneficial in heart failure with normal pump     function (diastolic heart failure).      Atorvastatin is one of a group of cholesterol lowering medicines called statins, which have     been shown to reduce cardiovascular disease in patients irrespective of whether cholesterol     levels are high or normal. It is not known whether atorvastatin also reduces fibrosis of the     heart which is one of the causes of diastolic heart failure.      Study hypothesis        1. To investigate the impact of aldosterone antagonism or statin therapy on markers of          collagen turnover in patients with diastolic heart failure.        2. To assess the impact of aldosterone antagonism or statin therapy on markers of diastolic          dysfunction and indices of clinical well being in patients with diastolic heart failure.   "
202894|NCT00505401|"     The development of a vaccine against HIV/AIDS has been primary focused on the structural     proteins (Env, Gag) of HIV-1 with the aim of inducing sterilizing immunity by blocking virus     entry. Alternative approaches are focused on new vaccine strategies aimed at modifying the     virus-host dynamic favouring the establishment of a long-term non-progressing disease status.     Such strategies target regulatory proteins that are the first to be expressed after infection     and are essential for viral replication, infectivity and pathogenesis. Thus, this approach     may be effective for both preventive and therapeutic vaccination strategies.   "
202895|NCT00505414|"     The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe     in the treatment of chronic tumor related pain compared to placebo.   "
202896|NCT00505427|"     The study will recruit 40 subjects with Polycystic Ovary Syndrome (PCOS) as defined by the     NIH criteria. The subjects will be pre-screened for insulin sensitivity using fasting insulin     and glucose levels and oral glucose tolerance test. The 20 most insulin resistant subjects     will undergo measurements of in vivo insulin action by hyperinsulinemic, euglycemic clamp.     Body composition will be measured by dual-energy X-ray absorptiometry (DEXA). Plasma lipids     and markers of oxidative stress will be measured. They will then receive open label     controlled release alpha lipoic acid (CRLA) at 800 mg twice daily for 16 weeks. After     treatment hyperinsulinemic euglycemic clamps, DEXA, plasma lipids and markers of oxidative     stress will be repeated.      Hypotheses: LA will improve insulin sensitivity in PCOS subjects; LA will reduce oxidative     stress, testosterone levels and improve cardiovascular risk factors.   "
202897|NCT00505440|"     This is a study to find out which type of computer screening and nursing support can improve     screening for high risk behaviors in doctor's offices. Recommendations call for doctors to     screen young people for many different behaviors and feelings such as depression, not wearing     seat belts, alcohol and drug use. Doctors rarely have time to complete these screenings. New     computers can help ask some of these questions and protect patient information. In addition,     nurse telephone calls can often help young persons with some of the behaviors receive     treatment. This study will examine which type of computer screening and follow-up will help     patients the most.   "
202898|NCT00505453|"     Vaccination is currently the most effective means of controlling influenza and preventing its     complications and mortality in persons at risk.      Once a year, a meeting of WHO experts takes place, leading to a recommendation on the     influenza A and B strains that should be used for the production of vaccine for the coming     influenza season.      This study is designed to test the safety/reactogenicity and the immunogenicity of the     Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains     recommended for the 2007-2008 season.   "
202899|NCT00505466|"     The goal of this study is to design a means of providing research families, from diverse     geographical locations, the chance to receive genetic testing after having been educated by     video, and meetings or telephone conversations with a genetic counselor/study professional.      This is an investigational study. About 800 people will be offered genetic testing. This     study is being performed only at MD Anderson.   "
202900|NCT00505479|"     Iodine is an essential component of thyroid hormone, which is necessary for many metabolic     processes as well as the maturation of the CNS. Deficiencies of iodine have deleterious     effects on both pregnant women and infants. The iodine status of the population after     implementation of the universal salt iodization program in Zhejiang province has not been     known. This study was to determine whether pregnant women show evidence of iodine deficiency,     and to examine the correlation between maternal urine iodine concentration and newborn     thyroid function.   "
202901|NCT00505492|"     Primary Objectives:        1. To test whether the addition of chemotherapy to radiotherapy improves the          progression-free survival for patients with stage I, II and IIIa malignant mixed          mesodermal tumor (MMMT) of the uterus.        2. To determine the acute and late toxicity profiles associated with this treatment          regimen.        3. To describe the effect of this treatment regimen on the patient's quality of life.   "
202962|NCT00497796|"     The purpose of this research study is to investigate whether or not oral maribavir is safe     and effective compared to oral ganciclovir for preventing CMV disease when administered for     up to 14 weeks in patients who have had a liver transplant.   "
202905|NCT00505544|"     Objectives:      Primary Objectives:        1. To establish concurrent criterion-related validity of the Brief Sleep Disturbance Scale          (BSDS) by correlating the scale with the Pittsburgh Sleep Quality Index.        2. To evaluate the construct validity of the BSDS through exploratory factor analysis.        3. To examine possible predictors of sleep disturbance.        4. To evaluate the reliability of the BSDS using Cronbach's coefficient alpha and          test-retest reliability.        5. To evaluate the sensitivity of the BSDS by administering it to the same group of          patients (n = 60) prior to treatment with a regimen associated with sleep disturbance,          during 4 weeks of treatment, and upon completion of treatment.        6. To evaluate the psychometric properties of the BSDS in a sample of community dwelling          adults.      Secondary Objective:      1. To obtain pilot data from a small sample of patients who will wear an actigraph for one     week.   "
202906|NCT00505557|"     The purpose of this study is to evaluate the feasibility and outcome of performing dual plane     breast augmentation with assistant of endoscope by axillary approach.   "
202907|NCT00505570|"     The purpose of this study is to evaluate migraine headache frequency in subjects who have     migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and     left upper chambers (atria) of the heart which normally closes at or soon after birth) who     are randomized to either undergo closure of the patent foramen ovale or continue with     standard medical management.   "
202908|NCT00505583|"     To evaluate the effects of single oral doses of MOA-728 compared to a positive control in     subjects on methadone therapy.   "
202930|NCT00505882|"     In this pilot study we are evaluating the efficacy of pramlintide on preventing weight gain     among early onset type 1 diabetes. We are also evaluating the safety and the effects of     treatment with pramlintide on early diagnosed type 1 diabetic subjects, especially among     pediatric subjects.   "
203041|NCT00498836|"     Patients with metastatic malignant melanoma will receive CP-4055 200 mg/m2/day intravenously     (IV) on Day 1-5 every four weeks and sorafenib 400 mg b.i.d. (twice daily) every day until     complete response or disease worsening/progressing.   "
202909|NCT00505596|"     The proposed study will determine the impact of providing complete information about all     prenatal tests for chromosomal disorders to racially/ethnically and sociodemographically     diverse women of all ages and allowing them to make informed choices regarding which tests -     if any - to undergo. Specifically, we propose to update a validated prenatal testing     decision-assisting tool (PT Tool) to incorporate new screening options and make it more     accessible to lower literacy and culturally diverse populations. We then will conduct a     randomized controlled trial comparing the effect of an informed free choice approach     consisting of providing complete information regarding and access to all prenatal testing     options to that of usual care among a diverse population of pregnant women.   "
202910|NCT00505609|"     The Standard Days Method® is a fertility awareness-based method of family planning in which     users avoid unprotected intercourse during cycle day 8 through 19. The method is most     appropriate for women with cycles that usually range 26-32 days. The clinical trial tested     the contraceptive efficacy of the Standard Days Method. A total of 478 women, age 18-39     years, in Bolivia, Peru, and the Philippines, with self-reported cycles of 26-32 days,     desiring to delay pregnancy at least one year were admitted to the study and followed for up     to 13 cycles of method use.   "
202911|NCT00505622|"     This is a multicentre, open-label extension study to evaluate the long-term safety,     tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated     PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or     E2007-G000-309 will be candidates for entering this extension trial, provided that they meet     the inclusion/exclusion criteria and have completed the core study, up to and including the     final efficacy visit.   "
202912|NCT00505635|"     The goal of this clinical research study is to learn if treatment with Temodar     (temozolomide), Velban (vinblastine), Cisplatin, Proleukin (interleukin-2), Intron-A     (interferon alpha), and thalidomide can help to control melanoma that has spread to other     parts of the body. The safety of this treatment will also be studied.   "
202913|NCT00505648|"     Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological     study of the T cell index phenotype and functionality in hypersensitivity syndrome.   "
202914|NCT00505661|"     Primary Objectives:        -  To determine the objective response rate of Letrozole when administered to patients with          advanced or recurrent borderline tumors or low-grade epithelial cancers from the ovary ,          fallopian tube or peritoneum.        -  To determine the time to tumor progression of patients with advanced or recurrent          borderline tumors or low-grade epithelial cancers from the ovary, fallopian tube or          peritoneum.        -  To identify the biological markers to predict response to Letrozole and study the          aspects of the hormones in these types of tumors.   "
202915|NCT00505687|"     The objective of this open-label extension is to assess the safety and tolerability of     long-term treatment of rotigotine in subjects with idiopathic PD.   "
202916|NCT00505700|"     The primary objective of this study is to establish the maximally tolerated dose of VELCADE     that can be administered with idarubicin and cytarabine in patients with AML. The secondary     objectives of this study are assessment of efficacy, safety, and pharmacokinetics of Velcade     when combined with Cytarabine and idarubicin. Various molecular markers associated with     response to Velcade, cytarabine, and idarubicin will be explored by utilizing microarray     analyses. The study endpoints are maximum tolerated dose and response to treatment.   "
202917|NCT00505713|"     Rexin-G is a tumor-targeted (pathotropic or disease-seeking) nanoparticle that when injected     intravenously, seeks out and accumulates in cancerous lesions, thus enhancing local drug     concentration within tumors. The goal of the adaptive trial design is to confirm the over-all     safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document     the significant clinical benefits required to support a Phase II registration protocol.   "
202918|NCT00505726|"     The goal of this clinical research study is to see if reflectance confocal microscopy works     as well as standard methods to detect cancer of the cervix or precancerous lesions.      Primary Objectives:        1. To identify potential clinical advantages for a noninvasive method of diagnosing          dysplasia and neoplasia in the cervix using reflectance confocal microscopy.        2. To obtain real time reflected light images in vivo of sites in the human cervix.        3. To access the effects of acetic acid as a contrast agent for in vivo reflectance          confocal imaging.        4. Evaluate the depth of penetration for the fiber optic confocal device and analyze the          diagnostic value of images taken from different depths.        5. Determine the sensitivity and specificity of this device for the diagnosis of CIN.   "
202963|NCT00497809|"     The overall purpose of this study is to assess the dose response, efficacy, and safety of     three different dose levels of AVI 014 (granulocyte colony-stimulating factor [G-CSF]) in     breast cancer patients at high (>20%) risk for chemotherapy-induced severe neutropenia.   "
202919|NCT00505739|"     Primary Objectives:        1. To determine the antitumor activity of Mifepristone (RU-486) in patients with advanced          or recurrent endometrioid adenocarcinoma or low grade endometrial stromal sarcoma          (LGESS).        2. To evaluate the quantitative and qualitative toxicities of Mifepristone in this patient          population.        3. To evaluate at a tissue level the effect of Mifepristone on estrogen and progesterone          receptors post treatment and to evaluate other markers that may reflect effects of          Mifepristone on cancer cell growth.        4. To evaluate the effect of the agent and dosing schedule on the patient's quality of          life.   "
202920|NCT00505752|"     This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind,     active-comparator, dose-finding study to evaluate a new investigational long-acting follicle     stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive     technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection     [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently     marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to     the number of fertilized oocytes.   "
202947|NCT00497601|"     The purpose of this study is:        1. To evaluate the Safety and Efficacy of four different short-course regimens of          Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who          are either treatment naive or treatment resistant to other antileishmanial drugs except          amphotericin B containing preparations.        2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in          treatment of Kala-azar.   "
202921|NCT00505765|"     The TURNS is a NIMH-funded contract for the evaluation of new compounds for the treatment of     cognitive impairments in schizophrenia (HHSN 27820044 1003C; P.I.: Steve Marder, M.D.).     Despite advances in the safety, tolerability, and effectiveness of antipsychotic medications     for the treatment of schizophrenia, many patients continue to be plagued by impairments in     social and work functioning. Persons with schizophrenia commonly show deficits in a number of     areas of cognition that include impairments in attention, memory, and executive functioning     (the ability and organize one's behavior). Importantly, a large body of literature now shows     a link between cognition and community functioning in schizophrenia. It is believed that     treatments that improve cognitive deficits may lead to improvements in work and social     functioning.      One approach to improve the community functioning of patients with schizophrenia is to     develop new agents that treat the cognitive deficits of the illness. A promising agent is     called AL-108. This drug is administered as a nasal spray. Studies in animals suggest that     this drug may protect neurons and may improve cognition in schizophrenia. The current study     is a twelve-week multicenter, double-blind, randomized clinical trial of two doses of AL-108     (5 and 30 mg/day intranasally) versus placebo in the treatment of persistent cognitive     dysfunction in schizophrenia. The study medication will be added to patients' current     atypical antipsychotic medication or to their current injectable first-generation     antipsychotic medication. The primary outcome measure will consist of the composite score of     the MATRICS neuropsychological battery. Secondary outcome measures will include scores on     symptoms, functional outcome, and safety measures. Sixty clinically stable patients with     schizophrenia, drawn from eight sites, will participate in the study. Twenty-five patients     will be enrolled at UCLA.   "
202922|NCT00505778|"     The purpose of this study is to compare the efficacy in maintaining remission of ulcerative     colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol     dosing regimen.   "
202923|NCT00505791|"     Heart failure (HF) is a disease that is caused by a reduced heart muscle function. Reduced     heart muscle function can occur as a consequence of reduced pumping activity from a weak     heart muscle or because of a stiff heart muscle. This study is looking at the effectiveness     of Natrecor (nesiritide) in patients that require hospitalization due to worsening heart     failure as a result of a stiff or thickened heart muscle. Natrecor is a man-made version of a     protein that my body makes on its own and has been approved for the treatment of patients     requiring hospital admission for heart failure and have shortness of breath at rest or with     minimal activity.      Natrecor has shown to lower the pressures in the heart and decreases the congestion in the     lungs. This study is being done to see if the addition of a Natrecor to standard medical     therapy for HF will improve symptoms faster or more completely than giving only the standard     treatment for CHF.   "
202924|NCT00505804|"     The purpose of the study is to determine whether dexmedetomidine is a more effective     medication than haloperidol in the treatment of agitation and delirium in patients receiving     mechanical ventilation in an intensive care unit. Haloperidol is a medication conventionally     used for this purpose.      The investigators will study only patients who have recovered from their illness to the point     that, were it not for agitation and delirium, they would no longer require mechanical     ventilation.      The investigators hypothesize that patients receiving dexmedetomidine will be able to     discontinue mechanical ventilation earlier than those receiving haloperidol.   "
202925|NCT00505817|"     The primary purpose of this study is to evaluate the effect of the two different protocols     (long protocol vs antagonist protocol) on oocyte / embryo quality.   "
202926|NCT00505830|"     Autism is considered as an invading disorder of the development. Asperger Syndrome (AS) is a     particular form of autism and is difficult to diagnose. The Autism Spectrum Quotient (AQ) has     been developed in order to measure the degree of autistic traits in autistic adolescent with     normal intelligence (Baron-Cohen et al. 2001, 2006). AQ comprises 50 questions, with 5 groups     of 10 questions assessing imagination, social skills, attention switching, attention to     detail and communication skills. Each of these items scores 1 point if the respondent records     abnormal or autistic like behaviour. The minimum score on the AQ is 0 and the maximum 50.      The principal objective of this study is to evaluate the accuracy of the French version of     Autism Spectrum Quotient questionnaire.      Secondary objectives are to:      Evaluate if EQ and SQ can distinguish adolescents without psychiatric syndromes from those     with classical autism or AS.      Evaluate if AQ, EQ and SQ can distinguish adolescents with psychiatric disorders from     autistic adolescents.      Define the threshold of positivity for the 3 questionnaires.   "
202927|NCT00505843|"     In this clinical trial, the safety of MK0657 when given with levodopa will be assessed in     patients with Parkinson's Disease. This study will also measure the effectiveness of MK0657,     when given in combination with levodopa, to improve motor symptoms and ameliorate dyskinesias     (uncontrolled movements of a part of the body) as compared to placebo.   "
202928|NCT00505856|"     The use of dermabond skin adhesive vs. skin staples for the closure of repeat c-section     incisions.   "
202943|NCT00497549|"     Carcinoma esophagus is a common cause of dysphagia. Once dysphagia occurs, a majority of the     tumours are advanced. Most of them would require some form of treatments for control of     dysphagia and to improve the quality of life. Surgery is the only hope for cure. It requires     complete removal of the esophagus. After removal of the esophagus, the stomach can be used as     a substitute for the esophagus. Anastomosis can be done in the neck either by a hand-sewn or     by a stapled anastomosis. The anastomotic leak rates reported in studies comparing hand-sewn     with stapled anastomosis are variable. Many non-randomized studies have reported leak rate as     low as 5% with stapled technique. However, the stricture rate is higher in the stapled group.     There is no randomized study comparing hand-sewn anastomosis with side-to-side stapled     anastomosis. Hence, the investigators planned a randomized trial comparing the anastomotic     sequelae after hand-sewn anastomosis with stapled anastomosis in the neck.   "
202929|NCT00505869|"     This proposal is aimed at testing the following hypotheses:        1. Cessation rates will be significantly greater for smokers in a mood management condition          versus a health & wellness condition during pregnancy and at 3 and 6 months postpartum.        2. Pregnant smokers who have a higher level of depressive symptomatology will quit          significantly less often in the health & wellness condition vs. mood management          condition; those with a lower level of depressive symptomatology will not demonstrate          this treatment difference.        3. Pregnant smokers who show higher levels of current depression at the start of the          intervention will quit significantly less often than those smokers with lower levels.      The mood management intervention will result in higher levels of adaptive coping behavior,     self-efficacy, social support, and perceived support from the counselor, and lower levels of     negative affect, rumination, and perceived stress, than the health & wellness intervention     and these variables will be related to abstinence. Thus, we will evaluate the effects of the     intervention (health & wellness and mood management) on hypothesized treatment mechanisms,     and assess the impact of those mechanisms on abstinence.   "
202931|NCT00505895|"     The goal of this clinical research study is to learn if there is a difference in transplant     outcomes between two different doses of melphalan given in combination with fludarabine     followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone     marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma.     This study will also look at whether treatment with a antibody called rituximab against a     specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host     disease after transplant. The safety of these treatments will also be compared.   "
202932|NCT00505908|"     Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain     injury, with approximately one quarter dying. Despite advances in aggressive neurosurgical     interventions, intensive care monitoring and overall supportive management, many of those who     do survive do not fully recover and are left with a varying degree of permanent disability.     It is therefore imperative that new methods of early interventions be explored.      One possible road to effective therapy is to examine the timing of secondary injury via a     biological marker, to help guide the timing of treatment directed specifically at early     oxidant injury. A more thorough understanding of how quickly oxidant injury occurs will allow     us to direct appropriate therapies targeted directly at oxidant injury within what is     currently thought to be a very narrow window of opportunity for intervention, possibly     peaking within the first two hours after the initial injury.      Potential participants include patients between the ages of 18 and 50 years who are admitted     to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury. Blood,     urine, and CSF (if patient requires a clinically indicated ventriculostomy) will be collected     over the first 5 days post-injury. Clinically-relevant patient progress, clinically required     interventions, neuro-imaging results, and demographics will be tracked while the patient is     hospitalized, with final neurological outcome measured at 3 months.   "
202933|NCT00505921|"     Primary Objectives:        1. To evaluate the role of autologous and allogenic stem cell transplantation with          Campath-1H for patients with peripheral T-cell lymphoma (PTCL).        2. To examine the impact of in-vivo purging with Campath -1H pre-autologous stem          transplantation for patients with PTCL.        3. To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H.        4. To evaluate the role of Campath -1H in the treatment minimal residual disease after          autologous transplantation for PTCL.   "
202934|NCT00497432|"     The primary purpose of this study is to assess whether hyperbaric oxygen treatment improves     neurological function in patients who exhibit white matter hyperintensities on MRI     examination.      The secondary goal of this study is to determine if it is possible using MRI to discern a     difference in perfusion of central nervous system tissue in regions of white matter     hyperintensities after hyperbaric oxygen administration as compared to hyperbaric air.   "
202935|NCT00497445|"     The objective of this study is to investigate what the value is of SET after a radiological     or surgical intervention for peripheral arterial disease in the aorto-iliacal,     femoro-popliteal and crural segments in comparison with a control group.   "
202936|NCT00497458|"     The purpose of this study is to evaluate whether increasing blood levels of androgen can     reduce some of the side-effects of anti-estrogen therapy (Arimidex)   "
202937|NCT00497471|"     The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the     efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area     of intense and perennial malaria transmission   "
202938|NCT00497484|"     We have recently demonstrated resistance to GHRH leading to GH deficiency in patients with     Pseudohypoparathyroidism type Ia (Mantovani et al., J Clin Endocrinol Metab, 2003. 88:     4070-4074). The purpose of this study is to evaluate the effect of at least 1-year GH     replacement in these patients. In particular, we will focus our attention on growth velocity     in children affected with this disease.   "
202939|NCT00497497|"     This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if     PRO95780 in combination with two different irinotecan-containing regimens is safe and     tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following,     or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and     bevacizumab-containing regimens. This study will also make a preliminary assessment of the     anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI     regimen plus bevacizumab.   "
202940|NCT00497510|"     To study the effect of chiropractic care and a specific exercise program on balance in older     adults.   "
202941|NCT00497523|"     To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation,     compared to placebo plus rescue salbutamol, in the relief of symptoms of asthma in young     children with persistent symptoms of asthma.   "
202942|NCT00497536|"     The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per     hour compared with multiple boluses per hour.      The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion     (CSII) versus continuous intravenous insulin infusion (CIII).   "
202944|NCT00497562|"     There are evidences of functional growth hormone (GH) deficiency, expressed by means of low     serum levels of insulin-like growth factor 1 (IGF-1), in a subset of fibromyalgia patients.     The efficacy of low GH doses versus placebo has been demonstrated in this population. We     assessed the efficacy and safety of GH added to standard therapy compared to standard therapy     alone in the treatment of severe, prolonged and well-treated fibromialgya patients with low     IGF-1 levels.   "
202945|NCT00497575|"     Long term follow-up of the patients with delayed TSH elevation or subclinical hypothyroidism     has been seldom reported. The purpose of this study was to explore the diagnostic criteria     for subclinical hypothyroidism and the initial dosage of L-thyroxine through long-term follow     up for infants with subclinical hypothyroidism ，and evaluate the curative effect.   "
202946|NCT00497588|"     early laryngeal cancer is a well known field with great controversy in treatment. two options     are available in treatment of patients the first one is partial laryngectomy and the second     one is radiotherapy.one of major concern of patients have been the quality of voice ,so we     design this trial to answer the priority of each options.   "
203089|NCT00499473|"     This phase II trial is studying how well sunitinib works in treating patients with recurrent     malignant gliomas. Sunitinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.   "
202948|NCT00497614|"     Biologics are routinely used for the treatment of rheumatoid arthritis (RA). Adalimumab is a     human monoclonal antibody that inhibit the Tumor Necrosis Factor alpha (TNF-alpha).     Identification of RA patients who respond to biologics is a challenging goal to avoid     unnecessarily, costly and potentially harmful treatment.      The aim of the study is to address if 18 F FDG is a valuable biomarker for the assessment of     the clinical response in RA with TNF-alpha blocking agent. Eight patients fulfilling the ACR     (American College of Rheumatology) criteria will by enrolled. Patient will receive adalimumab     according to the current guidelines i.e. 40mg /14 days sub cutaneously. The decision will     stand on a high activity of the disease defined by the DAS 28 (Disease Activity Score) above     5.1. Positron emission tomography will be performed before, 2 and 12 weeks after the begin of     the treatment. The response to adalimumab will by assessed by the SUV (standard Unit value)     measured on the inflammatory joints of hands, wrist, ankle, feet and knees and compared to     measurement of clinical (total swollen and tender joints count) echographic (synovium     thickness and power doppler) and chemical biomarkers (erythrocyte sedimentation rate, C     reactive protein).   "
202949|NCT00497627|"     Follow up of debanding patients   "
202950|NCT00497640|"     The purpose of the study is to determine the validity of the prediction model in reducing the     rate of CPAP titration failure and in achieving a shorter time to optimal pressure   "
202951|NCT00497653|"     To determine if oral DCI administration to women with PCOS increases the total DCI content in     urine and blood, and, if so, if that change is accompanied by i) an increase in DCI-IPG     release in blood (as determined by bioactivity) during an oral glucose challenge and ii) an     increase in whole-body insulin sensitivity.   "
202952|NCT00497666|"     Recent data show that Rosiglitazone treatment can reduce proteinuria in diabetic patients.     However, currently there are no trials that examine the effects of Rosiglitazone on kidney     disease progression, that is, doubling of serum creatinine or time to onset of end-stage     renal disease, in patients with diabetic nephropathy.      We decided to study retrospectively the possible association between rosiglitazone use and     clinical course of diabetic nephropathy, including rate of deterioration of renal function,     appearance and progression of microalbuminuria/proteinuria, survival and acceptance to renal     replacement therapy.   "
202953|NCT00497679|"     The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152     when given as a continuous 7-day infusion every week and every 2 weeks in patients with     advanced solid malignancies.   "
202954|NCT00497692|"     The purpose of this study is to demonstrate the absence of irritation potential (primary     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the     product Dermacyd Femina Delicata.   "
202955|NCT00497705|"     This study will investigate Ebstein's anomaly, a congenital abnormality of the tricuspid     valve of the heart and try to identify the genetic origins of the disease.      Adults and children 2 years of age and older with Ebstein's anomaly and healthy volunteers     may be eligible for this study. Participants undergo the following procedures:        -  Blood tests: Three tube of blood will be collected, with the total amount limited to          about half a teaspon for each two pounds of body weight.        -  Saliva sample collection: A small amount of saliva is collected by spitting into a          sterile container.        -  Oral (cheek) swab: Cells are collected from the mouth using a soft brush to swab the          inside lining of the cheek.        -  Electrocardiogram: The electrical activity of the heart is recorded using electrodes          placed on the chest.        -  Echocardiogram: Heart function is assessed using ultrasound.   "
202956|NCT00497718|"     The effect of chiropractic manipulation on spine-related pain and balance in older adults.   "
202957|NCT00497731|"     The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152     when given as a continuous 2-hour infusion every week and every 2 weeks in patients with     advanced solid malignancies.   "
202958|NCT00497744|"     Cefepime is a broad-spectrum antibiotic used in treating CAPD peritonitis. However, medical     knowledge has been lacking with regard to its pharmacokinetic profile after it has been     administered intraperitoneally. The current study aims at determining the drug level at     different time after the drug has been added into the peritoneal fluid in patients with CAPD     peritonitis. The results of this study will finally leads to rational prescription of this     drug at correct dosages.   "
202959|NCT00497757|"     The goal of this research study is to establish chimerism and avoid graft-versus-host disease     in patients who need a heart transplant.   "
202960|NCT00497770|"     This large, non-randomized observational study is being conducted to provide data about the     impact of ethnic origin on outcomes and resource utilization during the 2nd line treatment of     non-small cell lung cancer (NSCLC) in a routine medical care setting.   "
202964|NCT00497822|"     Studies have shown conflicting results of the effect of exercise on dementia patients.      The aim of this study is to examine the role of physical activity on the risk of cognitive     impairment and dementia in older persons.      To promote the benefits of aerobic exercise on dementia patients and encourage exercise     prescription in the management of dementia subjects.   "
202965|NCT00497835|"     An accelerometer with transmitting ability is worn on the wrist. Data of movements during     seizures will be analyzed to upgrade algorithm that will identify seizures.   "
202966|NCT00497848|"     The purpose of this study is to determine whether individual and/ or system orientated     interventions can help the problem of people with schizophrenia dropping out of their drug     treatment   "
202967|NCT00497861|"     This study compared the treatment effect of Activator Methods Chiropractic Technique (AMCT)     and manual Diversified type spinal manipulative therapy in a sample of patients with acute     and sub-acute low back pain.   "
202968|NCT00497874|"     The purpose of this study is to determine whether a home-based intervention matched to stage     of change (readiness) for using effective methods to prevent or reduce depression can improve     depression outcomes in primary care.   "
203013|NCT00498459|"     Physical activity is thought to be a key element in preventing the obesity epidemic and the     associated cardiovascular and metabolic diseases. However population-based studies directed     at promoting physical activity in youth have shown limited success in obesity prevention. The     aim of this study is to assess whether an intervention integrating socioecological changes,     which has the potential to induce sustained changes in physical activity, prevents overweight     and cardiovascular risk in adolescents.   "
202969|NCT00497887|"     Atherosclerotic cardiovascular disease is the major cause of morbidity and mortality in     Western societies. It is a complex genetic disorder with many genes involved and significant     gene-environment interactions. The aim of the study is to identify novel genetic- and     biological-markers of atherosclerosis. Atherosclerosis is assessed in the coronary arteries     using coronary angiography as well as in the carotid artery (intima-media-thickness) and     peripheral vessels (ankle brachial index). Association analysis of genetic and metabolic     markers with atherosclerotic burden will be performed to identify novel factors of     disposition to atherosclerotic vascular disease.   "
202970|NCT00497900|"     Previous studies have shown high proportions of vitamin D deficiency among elderly in     Denmark. Vitamin D is important for muscular function. The investigators intend to examine if     it is possible to improve cardiovascular function in patients with heart failure and vitamin     D deficiency by supplementation with vitamin D.   "
202971|NCT00497913|"     The purpose of this study is to determine whether a single injection of Dysport with a new     protocol at forearm is effective in the management of chronic lateral epicondylitis.   "
202972|NCT00497926|"     Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell     Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood     elements, help fight infection and assist in clotting) and kidney transplantation from the     same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired     result of this study is to allow your body to develop tolerance to the transplanted kidney.     Tolerance means that your body would see the transplanted kidney as part of you and not try     to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must     be taken on a daily basis. The purpose of this study is to determine if this procedure is     safe and to try to substantially reduce or even eliminate the need for anti-rejection     medications.   "
202973|NCT00497939|"     The purpose of this study is to assess the effect of saw palmetto and sanmiaoshan, on top of     alpha blocker, on urinary flow rate and BPH symptoms in patients with BPH.   "
202974|NCT00497952|"     The goal of this research study is to establish chimerism in hopes to halt disease     progression in patients with Multiple Sclerosis.   "
202975|NCT00497965|"     The purpose is to study the effect of chiropractic care on balance in older adults.   "
202976|NCT00497978|"     The purpose of this study is to reduce the postoperative morbidity and mortality in the     elderly hip fracture patient, by giving them taurine peri-operatively.   "
202977|NCT00497991|"     The purpose of this study is to assess safety and tolerability of multiple ascending doses of     AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with     relapsed acute myeloid leukaemia.   "
202978|NCT00498004|"     The primary objective of this study is to demonstrate clinical and statistical superiority of     quetiapine compared to risperidone in Korean version of Heinrich's Quality of Life Scale     after 8 weeks trial of drugs.   "
202979|NCT00498017|"     Infections are the most feared complications developing in patient who had had kidney     transplantation. The aim of this study is to document the local disease pattern among this     group of patients.   "
202980|NCT00498030|"     The purpose of this study is to identify risks that may contribute to increased insulin     resistance which may help explain some of the increased incidence of type 2 diabetes in     American Indian Youth, at the Rosebud reservation ages 5 to 18 years old. If specific     positive indicators of insulin resistance are present, individuals are recruited back in one     year for repeat of all measures.   "
202981|NCT00498043|"     This Phase II study randomized R-ACVBP and R-CHOP as induction treatment in patients from 18     to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted     IPI. The consolidation treatment is allocated according to the response to induction     treatment assessed by PET after the 2nd and 4th induction cycles.   "
202982|NCT00498056|"     The development of a safe and effective vaccine is the best strategy for preventing the     spread of HIV-1. The purpose of this study is to determine the safety and effectiveness of     and immune responses to an HIV vaccine regimen in healthy adults at risk for HIV infection.   "
202983|NCT00498069|"     Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in     vasculogenesis   "
202984|NCT00498082|"     EsophyX is a promising endoscopic treatment for gastro-esophageal reflux disease. It is not     known whether there are some pre- or per-operative anatomic or pathophysiological findings     which may influence outcome.      The aim of this trial is to study a series of parameters acquired during the pre-therapeutic     work-up or during the procedure and their influence on the outcome of the procedure.   "
202985|NCT00498095|"     Patients who had received kidney transplantation may suffer from rejection. Recently,     positive staining for C4d in kidney biopsies of malfunctioning transplant kidney is     increasingly recognized as an important prognostic indicator of poorer long-term kidney     outcome. Data is, however, lacking in Hong Kong.   "
203171|NCT00507052|"     In our opinion, it is worth to check an ability of antioxidant therapy to produce a favorable     effect on Residual Renal Function.      The aim of our study is to investigate the effect of N-acetylsysteine on RRF in prevalent HD     patients.   "
202986|NCT00498108|"     This is a multicenter, open-label trial to assess safety and tolerability of rotigotine in     subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up     to 1 year in subjects who previously participated in SP790 (6-month pivotal trial) or SP794     (sleep lab trial). Subjects who successfully completed the Maintenance Period and the Taper     Period of SP790 or SP794 are allowed to enroll in this trial.   "
202987|NCT00498121|"     Our aim in this study is to investigate the potential role of serum ProCT as an early     diagnostic marker and later prognostic indicator for VAP.   "
203011|NCT00498433|"     Part 1 determined: aliskiren, amlodipine and angiotensin II concentrations in interstitial     fluid of fat and skeletal muscle; aliskiren and angiotensin II concentrations, and renin     activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren,     amlodipine and angiotensin II concentrations, and renin activity and concentration in plasma.      Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone     system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle     tissue in obese patients with hypertension in comparison to amlodipine.   "
202988|NCT00498134|"     Gastric cancer is the second leading cause of cancer deaths in the World. In China, gastric     cancer exceeds all other cancer mortality except lung cancer. Helicobacter pylori infection     is an important cause of gastric cancer. We have previously started a randomized     placebo-controlled chemoprevention trial in Changle in 1994 to address the issue of whether     eradication of H. pylori alone is able to prevent or reduce the risk of gastric cancer. The     project involved 1600 subjects and is still ongoing. On the other hand, our laboratory     research indicated that an abnormally high expression of an enzyme cyclooxygenase-2 was found     in gastric cancer and inhibition of this enzyme by a new drug (specific cyclooxygenase-2     inhibitor) could kill the cancer cells. The same drug is approved now for use in treatment of     hereditary colon cancer syndrome (Familial Adenomatous Polyposis, FAP), in the same rationale     of tumour suppressive property of this drug. We are now initiating a second chemoprevention     study to assess the addition of this specific cyclooxygenase-2 inhibitor together with     eradication of H. pylori on prevention or reduction of the risk of gastric cancer and to     assess whether the combination can reverse pre-cancerous lesions in the stomach in the     high-risk population. The proposed site is Shangdong, China with very high prevalence of     pre-cancerous lesions in asymptomatic H. pylori carriers. We plan to recruit 1500 H. pylori     positive subjects for this randomized placebo-controlled study. H. pylori carriers will be     randomized to receive treatment for the infection or placebo, followed by specific COX-2     inhibitor or placebo for 3 years. The results will have significant impact on prevention of     gastric cancer on a national scale and worldwide.   "
202989|NCT00498147|"     The primary objective of this study is to identify whether cardiovascular complication rates     are lower in patients who participate in managed diabetes care, in comparison to provincial     and national rates. This study will involve an electronic medical record (EMR) chart audit,     augmented by a manual review of hospital and other pertinent medical records, as necessary.   "
202990|NCT00498160|"     The goal of this research study is to establish chimerism and avoid graft-versus-host disease     in patients with kidney failure allowing a reduction or cessation of immune-suppressive     therapy.   "
202991|NCT00498173|"     This study will evaluate the effectiveness of atomoxetine in treating children with attention     deficit hyperactivity disorder symptoms associated with autistic disorder, Asperger's     syndrome, and pervasive developmental disorder, not otherwise specified.   "
202992|NCT00498186|"     This is a multi-center, open-label extension trial conducted at the same European sites that     participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety     and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic     Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will     be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses     and patch sizes).   "
202993|NCT00498199|"     This study consists of two parts. The first part is a survey to examine vision-specific     health-related quality of life in a cohort of patients with multiple sclerosis. We test     visual impairment like visual acuity, visual field, colour discrimination, contrast     sensitivity, eye movement. The aim of this part is to examine the association between     responses to the quality of life scale and objective measures of visual impairment.      The second part is an open controlled study, in which we measure motion detection threshold     in MS patients with oscillopsia due to pendular nystagmus and in a group of control subjects.     The objective of this part is to determine whether patients with pendular nystagmus develop     adaptation to oscillopsia using increased threshold of motion detection. We plan to test the     effect of visuo-motor rehabilitation on this threshold in patients with oscillopsia due to     pendular nystagmus.   "
202994|NCT00498212|"     The purpose of this study is to find out if a new investigational hepatitis B virus (HBV)     vaccine, HEPLISAV™, is safe and effective for end-stage renal disease (ESRD) patients. Two     dose levels will be studied: a single dose and a double dose. We expect both dose levels to     safely immunize patients against HBV. The study will determine which dose does this best.   "
202995|NCT00498225|"     In patients with unresectable advanced pancreatic cancer, non-inferiority of TS-1 monotherapy     and superiority of GEM + TS-1 combination therapy to gemcitabine (GEM) will be verified using     survival time.   "
202996|NCT00498238|"     We evaluated the effect of levothyroxine in subclinical hypothyroidism (SCH) on arterial     stiffness, lipid profile and inflammation. Thirty-four patients with SCH were included.     Patients were treated with levothyroxine for 7 months. Arterial stiffness was evaluated by     Augmentation index (AIx). After accomplishing euthyroidism, the AIx decreased from 8.3±17.2     to 6.5±14.3(P<0.01) and AIx percentage decreased from36.2 11.5 ± to 9.1±33.2 (P =0.03).     Systolic blood pressure decreased from 20±134.7 to mmHg 13.7±127.6 (P<0.01). No significant     improvement was found in other parameters. In patients whose AIx's decreased, LDL-cholesterol     levels decreased by 37.1±-15.5 mg/dl compared to the patients whose AIx's didn't decrease and     LDL-cholesterol increased by 57.4±24.1 mg/dl (P=0.057). We concluded that in patients     suffering from SCH, treatment with levothyroxine had a significant beneficial effect on     arterial stiffness and systolic blood pressure and no effect on lipid profile or     inflammation.   "
203009|NCT00498407|"     Patients with histologically or cytologically confirmed metastatic colorectal cancer (CRC)     who have failed a first-line chemotherapeutic regimen containing oxaliplatin and     5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational     Medicinal Products (IMPs), will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5     every four weeks until complete response or disease worsening/progressing.   "
203010|NCT00498420|"     The natural history study of the rare lysosomal disease alpha-mannosidosis will answer the     question; why the rare disease develops as it does?   "
203012|NCT00498446|"     An atrial septal defect (ASD) is a hole in the heart that can lead to heart failure.     Depending on the size and severity of the ASD, They can be treated during a heart     catheterization with a special device that can permanently seal the ASD, but knowing the     exact size and severity of the ASD is crucial. Newer MRI techniques may provide a better way     at diagnosing the size and severity of an ASD. We compared MRI to other standard clinical     ways for evaluating an ASD.   "
203014|NCT00498472|"     Hospitalizations for acute heart failure syndromes (AHFS) are associated with a high     rehospitalisation and mortality rate. The aim of this study is to assess if the measurement     of NT-proBNP levels before discharge may improve the prognosis of the patients recently     admitted to hospital for AHFS   "
202997|NCT00498251|"     Background :      Acute lung injury (ALI) occasionally occurs after pulmonary resection and carries a bad     prognosis with a high mortality rate ranging from 20 to 100%.      Objectives :        1. to evaluate pre-, intra- and postoperative changes in hemodynamics, oxygenation indices          as well as intra- and extravascular lung water using simple thermodilution technique and          continuous arterial pressure analysis        2. to test the efficacy of inhaled beta2 -adrenergic agonist versus anticholinergic agents          to reduce lung edema in patients undergoing thoracic surgery and in pigs subjected to          lipolysacharide-induced ALI.      Design of the research protocol:        -  Prospective controlled trial including surgical patients with high risk factors for ALI          (n=60) allocated to receive inhaled drugs (randomised, double-blind, cross-over mode).        -  Main measurements:      Intra-thoracic blood volume, intra- and extra-vascular lung water, hemodynamic parameters     (CO, systolic arterial pressure/flow variations, dPmax, MAP, CVP), oxygenation indices     (PaO2/FIO2), ventilatory parameters, clinical outcome data, histochemical and pathological     data.      Glossary CO = cardiac output; dPmax = maximal arterial pressure slope; SAP-V = systolic     arterial pressure variations; Flow–V = Flow variations; MAP = mean arterial pressure; CVP =     central venous pressure; PaO2=arterial oxygen pressure; FIO2= oxygen inspiratory fraction   "
202998|NCT00498264|"     Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to     reduced physical function and frequent use of health care services. Exercise training is     commonly recommended as a treatment.      The purpose of this study is to determine whether a supervised resistance muscular exercise     (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain.      The practical of the RME reduces the pain of participants with FMS.   "
202999|NCT00498277|"     Primary Objective:      The purpose of this study is to determine whether or not combined quantitative diffusion and     fat MR imaging techniques can differentiate between benign and malignant vertebral fractures.   "
203000|NCT00498290|"     The purpose of this study is to determine whether ERAS is safe and can decrease surgical     stress, increase functional recovery and reduce complication rate in colorectal surgery.   "
203001|NCT00498303|"     Annual trial for registration of trivalent split influenza vaccine with the strain     composition of the season 2007/2008 in healthy adult and elderly subjects   "
203002|NCT00498316|"     The goal of this clinical research study is to learn if combining cord blood units will be     safe and result in the cells taking faster in recipients. The cord blood units will have     their cell number increased in the lab using cells from a family member or they will be     collected from an unrelated healthy donor.   "
203003|NCT00498329|"     This study will examine how the areas in the brain are connected when they are controlling     two finger movements at the same time. It will look at how people use what they see to help     guide two different movements. This ability, which is important in everyday life, can be a     problem for patients with neurological problems.      Healthy right-handed volunteers 18 years of age and older may be eligible for this study.     Candidates are screened with a medical history, physical examination and magnetic resonance     imaging (MRI) of the brain. MRI uses a strong magnetic field and radio waves to obtain images     of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong     magnetic field. The subject lies on a table that can slide in and out of the scanner, wearing     earplugs to muffle loud noises that occur during the scanning.      Participants undergo functional MRI (fMRI). This is a standard MRI that is done while the     subject performs skilled finger tasks in response to instructions they see on a screen.     Researchers localize brain areas which show activity changes while the tasks are performed.     Before the test session begins, subjects complete a questionnaire and have an opportunity to     practice the task.      Subjects control the position of one or two cursors on a screen using one or two fingers.     They perform tracking or pointing tasks according to what they see on the screen. During the     single-task experiment only one task is presented on the screen. During the dual-task     experiment, two tasks are presented on the screen. Subjects perform either the single-task or     dual-task experiment, but not both. The fMRI lasts about 90 minutes, with subjects asked to     lie still during the scan for up to 9 minutes at a time.      After completing the fMRI, subjects are scheduled for a research electroencephalogram (EEG)     and magnetoencephalogram (MEG). The test is done while the subject performs tasks so that     researchers can learn about the timing of changes in activity in certain brain regions during     performance of the same tasks done for the fMRI.   "
203004|NCT00498342|"     Primary outcome: Serum creatinine change at 4 hours and 48 hours following 4 doses of     N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine.      Secondary outcome: Serum Cystatin C change at 4 hours and 48 hours post 4 doses of     N-acetylcysteine compared to baseline serum Cystatin C.   "
203005|NCT00498355|"     Uveitis is an inflammation (swelling and irritation) inside the eye, affecting the uvea. The     uvea is the layer of the eye between the sclera and the retina and provides most of the blood     supply to the retina.      Uveitis is an important cause of visual loss. There are 30,000 new cases of legal blindness     each year due to uveitis in the U.S. Sight-threatening complications associated with uveitis     include macular edema, which may persist even when inflammation is controlled. The only     current treatment for cystoid macular edema (CME) in uveitis patients is oral or regional     steroid injections. For patients who don't respond to steroids or who are unable to tolerate     steroid therapy, there are no other medical treatments.      The aim of this study is to determine if ranibizumab, an FDA-approved treatment for     neovascular age-related macular degeneration, is an effective treatment for those patients     with uveitis-induced CME who are unable to be treated with or non-responsive to steroids.   "
203006|NCT00498368|"     This study was about IgA nephropathy, a form of kidney disease characterized by the presence     of blood and protein in the urine. This study was done to determine if the medication     rituximab could reduce protein in the patient's urine.      Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg     of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in     reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.   "
203007|NCT00498381|"     Aim of study:        1. To compare the level of IL-6 mRNA expression in peripheral blood monocytes between          normal subjects and patients with OSAS        2. To compare the activation of NF-B in peripheral blood monocytes between control          subjects and patients with OSAS; Check the correlation between level of L-6 mRNA          expression and activation of NF-kB        3. To determine the effect of CPAP on the activation of NF-kB and IL-6 in peripheral blood          monocytes in patients with moderate –severe OSAS   "
203008|NCT00498394|"     This pilot study is a randomized, controlled clinical trial to compare anthropometric and     metabolic changes associated with six months of weight management by means of a very low     carbohydrate diet or a calorically-restricted low fat diet. We hypothesized that the low fat     diet would be associated with more weight loss and improvement of cardiovascular risk factors     than the low carbohydrate diet.   "
203015|NCT00498485|"     Chronic fatigue syndrome is a disabling illness for which there is no specific treatment. As     a group, CFS patients have disturbed sleep with frequent arousals and the sense of not having     slept upon awakening. Xyrem (Sodium oxybate) is known to improve deep sleep and so may reduce     the sleep disturbances of CFS leading to better sleep with less fatigue. Its ability to     produce the rapid onset of deep sleep is a reason it became a street drug, but its     availability is currently limited via distribution through a single centralized pharmacy.     Xyrem has been successfully used based on results from a study on patients with fibromyalgia     (FM), an ailment closely resembling CFS. However, in that study, the researchers provided no     information as to whether patients had FM alone or FM plus CFS. Thus, it is not clear from     this study just which patient may be helped. I have prescribed Xyrem for patients who have     both FM and CFS with good results. In this study, funded by the company that makes Xyrem, I     propose testing the drug's efficacy on patients with CFS alone - that is, they do not have     fibromyalgia.      Volunteers for this study will complete paper and pencil questionnaires about their symptoms     as well as a computerized test to assess their degree of brain fog. They will then be     randomly assigned to one of two groups, placebo or drug. Volunteers will not know what group     they are in until the end of the study. Only the drug group will receive the medication. The     placebo group will receive a substance that looks identical to the real medicine but with no     active ingredients. The medication comes as a liquid and patients will start taking an     initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5     hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will be told     to skip taking the second dose. We will call patients weekly to see how they are doing on the     drug. If they have tolerable side effects or report significant improvement, we will     maintain the dose. But if patients report no effect of treatment, the dosage will be     incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is     reached.   "
203016|NCT00498498|"     The goal of this study is to answer the following questions:        -  What is the time course of the expected changes in endothelin levels during the first          two weeks after injury and how does this relate to outcome?        -  What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and          cerebrospinal fluid and type of injury, from CT scans and GCS?        -  What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and          cerebrospinal fluid and outcome measurements like GOSE, ICP and CT scans?        -  What is the relation between neurohormones related to the neutral endopeptidase (NEP)          (ANP, BNP and cGMP) in plasma and cerebrospinal fluid and type of injury, from CT scans          and GCS?        -  What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and          cerebrospinal fluid and markers for apoptosis?   "
203017|NCT00498511|"     Both upper gastrointestinal endoscopy and colonoscopy are recommended in men and     post-menopausal women with iron deficiency anemia. Due to lack of data on the yield of these     endoscopies in young men, they are currently investigated as older men. The aim of this study     is to evaluate prospectively the prevalence of various gastrointestinal lesions in young men     with iron deficiency anemia. Our hypothesis is that the diagnostic yield of colonoscopy in     young anemic men without gastrointestinal symptoms is very low, especially if a potential     lesion is detected during upper gastrointestinal endoscopy. Therefore, this study will try to     identify predicting factors regarding the yield of both endoscopies. Another purpose is to     evaluate the outcome of patients with negative endoscopic results, during a follow-up of two     years.   "
203018|NCT00498524|"     The purpose of this study is to determine if heredity influences the risk of life-threatening     heart rhythms (ventricular tachycardia and ventricular fibrillation) after heart attack     (myocardial infarction).   "
203019|NCT00498537|"     Introduction: Aldosterone seems to have deleterious effects on the kidneys. Many animal     studies and few clinical trials now have shown that suppression of aldosterone by aldosterone     receptor blockers ameliorated these effects.      Method: In a double-blind, cross over study, 24 patients with diabetic nephropathy who were     already receiving either ACE inhibitor(lisinopril 20-40 mg/day ) or ARB( losartan 25-100     mg/day )were given spironolactone( 25 mg during the first month and 50 mg during the second     and third month if serum K remained ok) or matching placebo with 1 month of washout in     between. All patients were from a single center and exclusively male veterans. Blood     pressure, serum creatinine, serum K and spot urine protein/creatinine were measured at the     beginning and end of each study period. The study was started in May of 2003 and completed in     May 2006.   "
203020|NCT00498550|"     Many individuals with schizophrenia also suffer from marijuana addiction. Clozapine, an     atypical antipsychotic medication, may prove useful at preventing drug relapse in     schizophrenic individuals who are seeking treatment for marijuana addiction. The purpose of     this study is to compare the effectiveness of clozapine, vs. treatment-as-usual with other     oral antipsychotics at reducing marijuana use in schizophrenic individuals.   "
203082|NCT00499382|"     Primary Objective:        -  Evaluate the agreement between radionuclide ventriculography (RNV) and gated F-18          fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) in          calculating left ventricular ejection fraction (LVEF), end diastolic volume (EDV) and          end systolic volume (ESV).   "
203021|NCT00498563|"     Hypobaric hypoxia (decreased oxygen supply to body tissues due to low atmospheric pressure)     caused by exposure to high altitude disrupts sleep. Sleep deprivation is associated with     degraded post-sleep performance of neurobehavioral tasks. The lowest altitude at which sleep     and/or post-sleep performance are affected is not known. The study hypothesis is that sleep     and/or post-sleep performance of neurobehavioral tasks will occur due to hypobaric hypoxia at     altitudes of 8,000 or less.   "
203022|NCT00498576|"     Recently we have shown that melatonin secretion is impaired in rats with metabolic syndrome.     We have also demonstrated that exogenic melatonin supplementation can improve blood pressure     profile in nondipper patients.      The aim of this study is to find whether there is a difference between melatonin secretion in     hypertensive kidney recipients versus normal hypertensive patients. Secondly, to ask if     there is any correlation between melatonin secretion and adiponectin levels.   "
203023|NCT00498589|"     -  PHASE: II        -  TYPE OF STUDY : With direct benefit        -  DESCRIPTIVE: Multicenter, randomized, double-blind study        -  INCLUSION CRITERIA: Steroid-dependent ulcerative colitis        -  OBJECTIVES: To show superiority of methotrexate vs placebo in inducing steroid-free          remission in steroid-dependent ulcerative colitis        -  STUDY TREATMENTS: Methotrexate 1 intramuscular injection (25 mg) per week Placebo 1          intramuscular injection per week        -  NUMBERS OF PATIENTS: 55 patients in each group, i.e. a total of 110 patients        -  INCLUSION PERIOD: 24 months        -  STUDY DURATION: 36 months        -  EVALUATION CRITERIA: Remission without steroids, immunosuppressives and without          colectomy at 16 weeks of treatment.   "
203024|NCT00498602|"     To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active     immunization, in subjects with mild to moderate Alzheimer's disease.   "
203025|NCT00498615|"     Raynaud's phenomenon is thought to occur when, in response to cold or emotional stress, there     is closure of the digital arteries and cutaneous arterioles leading to the clinical finding     of sharp demarcated digital pallor and cyanosis of the distal skin of the fingers and/or     toes. Patients often continue to experience problems despite current available treatment. The     investigators' study will investigate the use of a new vasodilator called Fasudil, a     Rho-kinase inhibitor. The investigators' hypothesis is that Fasudil will prevent     vasoconstriction of digital and cutaneous arteries during a standard laboratory based cold     exposure and will therefore improve digital blood flow and skin temperature recovery time     following cold challenge. These data will provide the rationale for a more elaborate clinical     trials in real life situations.   "
203026|NCT00498628|"     The purpose of this study is to determine whether quetiapine fumarate extended release is     effective in the treatment of alcohol dependence in very heavy drinkers.   "
203027|NCT00498641|"     To compare the effects of perceptual learning with patching on improving visual acuity and     contrast sensitivity in payient with anisometropic amblyopia.   "
203028|NCT00498654|"     The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine     in healthy adult subjects.   "
203029|NCT00498667|"     A retrospective analysis will be performed regarding the usefulness of PET/CT performed     following 2 cycle of chemotherapy in evaluation of progression, free survival and overall     survival of patients with aggressive non Hodgkin Lymphoma.   "
203030|NCT00498680|"     A prospective, randomized, 3-arm parallel trial on 45 males with ED that were never exposed     to PDE5i therapy (naïve patients) will be enrolled.In each group, every patient will receive     three treatment regimes (Viagra®50mg & Levitra®10mg, Viagra®100mg, Levitra®20mg), in     different sequences of administration in such a manner that eventually each patient will     receive all regimes in a double- blinded fasion.Safety will be evaluated at pre- screening by     measuring hourly vital signs (blood pressure, heart rate)for 4 consecutive hours after taking     half-dose combination. Any decrease in blood pressure of 20 mmhg below baseline will exclude     the subject from the study. Effcacy will be evaluated by questionnaires (IIEF, Quality of     erection questionnaire, grade of erection scale, Sear, QVS and Sexual Encounter Profiles for     each sexual event). Non-parametric statistical analysis of the collected data Comparing the 3     groups will be performed.   "
203031|NCT00498693|"     Specific Aim        1. To identify specific SNPs of HIF-1 gene related to cardiovascular disease in OSA          patients (CVD-OSA)        2. To assay the functional activity of high risk SNPs of HIF-1 on the transcription of VEGF          gene        3. To confirm that the serum level of VEGF in CVD-OSA patients with high risk SNPs of HIF-1          are higher than CVD-OSA patients without   "
203032|NCT00498706|"     This study will compare the effectiveness of telephone versus face-to-face administration of     cognitive behavioral therapy in treating people with depression.   "
203033|NCT00498719|"     Primary Objectives:        1. To evaluate the feasibility of enrolling children and adolescents with newly diagnosed          brain tumors, leukemia, or lymphoma in a program designed to prevent the academic and          cognitive declines that commonly result following central nervous system (CNS) disease          and treatment.           Hypothesis 1: Despite the rigors of disease and treatment, children and adolescents will          be able to participate in the CTP while they are receiving treatment for cancer. The          high participation of our patients in routine school activities during treatment          suggests that they will have the energy and interest required to participate in          cognitive training.        2. To evaluate whether a Cognitive Training Program (CTP) might be helpful to patients in          preventing attention deficits that commonly result following CNS disease and therapy.           Hypothesis 2: Patients in the CTP arm of the study will show fewer declines in          neurocognitive performance at the end of training and again six months later, as          compared with the control group who will receive the usual services provided by the          Education Program in Pediatrics.        3. To explore the relationship between CTP treatment compliance and stability/decline in          cognitive and academic performance in children and adolescents who are being treated for          brain tumors, leukemia, and lymphoma.      Hypothesis 3: Level of compliance with CTP treatment will be predictive of a patient's     performance on neurocognitive measures.   "
203111|NCT00499785|"     RATIONALE: Learning about physical ability and mental function over time in older patients     with acute myeloid leukemia may help doctors learn about the long-term effects of treatment     and plan the best treatment.      PURPOSE: This clinical trial is assessing physical and mental status in older patients with     newly diagnosed acute myeloid leukemia.   "
203034|NCT00498732|"     Specific Aim        1. To verify the differentially expressed genes and pathways between normal and OSA          patients, and OSA patients before and after CPAP treatment.           Genes with changes in expression of more than two-fold between normal and OSA patients          as well as OSA patients before and after CPAP treatment were thought as confirmed and          were selected for further validation study.        2. To correlate the confirmed genes with the clinical presentations and CPAP effects in          another 50 OSAS subjects to validate the altered gene expressions and pathways involved.           To investigate the correlation of genes confirmed from RT-PCR (identified gene), another          50 OSAS subjects are included in the study. We analyze the correlation between          identified gene and the clinical manifestations and CPAP effect in these 50 OSAS          patients.        3. To establish a cell model to investigate the differentially expressed genes and the          putative biological pathways involved in OSA syndrome.      To investigate the functions of genes identified in the first and second year (gene of     interest), we establish a cell model with human monocyte cell line U937. We investigate the     function of gene of interest through overexpress or knockdown.      Objectives The objectives of this project are to confirm the gene profiled from comparing     normal and OSA patients as well as OSA patients before and after CPAP treatment, to     investigate the correlation between altered gene expression and clinical presentations and     CPAP effects of the OSAS and to identify and confirm corresponding pathway. This study will     enhance our understanding of the individual constitution on widely different clinical     characteristics and therapeutic variations. All these efforts will also help us to interpret     its molecular mechanisms and develop prediction and diagnosis strategies of OSAS. The     long-term objectives are to develop therapeutic strategy other than CPAP of OSAS.   "
203035|NCT00498745|"     To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a     reference capsule and an oral solution in healthy subjects.   "
203036|NCT00498758|"     The purpose of this study is to evaluate the benefits of a biomechanical wedge system - The     APOS system, for improving the stability of gait, mobility and quality of life in Parkinson's     disease patients.   "
203037|NCT00498771|"     The purpose of this study is to determine what effects aquatic exercise has on participants     with Lymphedema.   "
203038|NCT00498784|"     The purpose of this study is to evaluate the changes in the quality of life, as well as in     the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine     system, over the first 12 months of use. Patients switching from oral contraception to an     intrauterine contraceptive device (here: MIRENA) will be observed in the first year post     MIRENA insertion.   "
203042|NCT00498849|"     The aim of this study are (1) To genome-wide profile the gene expression patterns of     peripheral blood mononuclear cell (PBMC) in patients with obstructive sleep apnea (OSA) (2)     To profile the gene expression patterns change before and after treatment with continuous     positive airway pressure (CPAP) (3) To correlate the altered gene expression with the     severity of the disease and outcome of OSA patients   "
203043|NCT00498862|"     Specific aim To examine the effect of catecholamines on the modulation of intermittent     hypoxia induced TNF- in human monocytes from both healthy subjects and OSA patients (2). To     map the signaling pathway of catecholamines regulating the intermittent hypoxia induced TNF-     expression.      (3). To explore the potential therapeutic effects of  or  agonists/antagonists on     intermittent hypoxia induced TNF- expression   "
203044|NCT00498875|"     Primary Objectives:        -  Develop and pilot test an innovative intervention to determine its feasibility and          acceptability to patients. Recruitment rate, patient satisfaction, attendance,          questionnaire completion rates and the reliability and validity of the questionnaires          will be assessed.        -  Conduct preliminary analyses on the efficacy of the intervention in improving patients'          depression. Evaluate whether depression levels in patients receiving the intervention          decreases, and whether the decrease is greater among those who complete more sessions.        -  Test the relationship between patients' depression levels and adherence to swallowing          rehabilitation and to dental preventive maintenance regimens.   "
203045|NCT00498888|"     -  Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong          sensation to void.        -  UUI usually associated with reduced bladder capacity.        -  The pathophysiology is unclear.        -  Pelvic floor muscle dysfunction and detrusor instability have been suggested as possible          mechanisms.        -  Standard treatment includes anticholinergic medication and behavior modification.        -  The study aims to compare the long term effectiveness of 4 different approaches to the          treatment of women with Urge Urinary Incontinence (UUI):             1. Pelvic Floor Rehabilitation (includes muscle training+behavioral               intervention+bladder training)             2. Pelvic Floor muscle training alone             3. Bladder Training alone             4. Drug treatment with Tolterodine.        -  Study variables will include: impairment ratings, quality of life, and          cost-effectiveness.        -  This study addresses three issues:             1. The long term efficacy and cost-effectiveness of the various treatment options.             2. To identify the factors involved in determining the effectiveness of drug or               behavioral therapy.             3. The pathophysiology of UUI. By subdividing the rehabilitation group into 3 arms, we               hope to shed light on the mechanism of dysfunction. A better response in one group               will help localize the problem to pelvic floor muscles or to detrusor instability.   "
203046|NCT00498901|"     RATIONALE: Aromatase inhibitors, such as letrozole, prevent the formation of estradiol, a     female hormone. Giving letrozole together with goserelin, leuprolide, or surgery may be an     effective treatment in women with hormone-dependent breast cancer.      PURPOSE: This phase II trial is studying how well giving letrozole together with goserelin or     leuprolide works in treating premenopausal estrogen receptor-positive patients with stage IV     breast cancer.   "
203047|NCT00498914|"     A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate,     efficacy, safety and tolerability of YM155   "
203048|NCT00498927|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients     with recurrent glioblastoma multiforme or other malignant glioma.   "
203049|NCT00498940|"     The purpose of this study is to investigate the efficacy of optimized temporary biventricular     pacing (BiVP) in patients undergoing open-heart surgery with preoperative LV dysfunction and     an intraventricular conduction delay. This study will compare extended temporary     biventricular pacing versus standard of care by assessing patients randomized to the two     groups, from the conclusion of cardiopulmonary bypass, until the conclusion of pharmacologic     circulatory support in the intensive care unit. In addition, effects of biventricular pacing     will be tested in all patients, at three time points, using different measures of blood flow.     Results from this research will demonstrate whether temporary BiVP improves cardiac output     after open-heart surgery and whether ventricular pacing optimization increases cardiac output     in this setting. Success would lead to the development of recommendations for use of BiVP     postoperatively and would stimulate the development of pacemakers with appropriate features.     Our primary hypothesis is that the optimum pacing protocol (POPT) will increase cardiac index     (CI) by 15% (from approximately 2.30 to 2.64 L/min/m2) compared to standard of care as     measured by thermodilution 12-24 hours postoperatively. Secondary objectives include defining     POPT at three time points within 24 hours of surgery. We will examine which forms of cardiac     dysfunction benefit from temporary pacing using direct and indirect measures of perfusion and     cardiac function. We will also analyze survival, length of stay, incidence of arrhythmias,     and cost of postoperative care.   "
203050|NCT00498953|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     tumor cells. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving combination chemotherapy together with radiation therapy, with     or without lapatinib, before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed or eliminate the need for surgery.      PURPOSE: This phase I/II trial is studying the side effects and best dose of combination     chemotherapy given together with radiation therapy with or without lapatinib and to see how     well it works in treating patients with locally advanced cancer of the larynx or hypopharynx.   "
203051|NCT00498966|"     This is a Phase II study. Patients with kidney carcinoma will be considered in two groups.     The goals of this study are:        -  To measure clinical benefit defined as tumor response or progression-free survival for          more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed          or have progressed on a VEGF receptor inhibitor        -  To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney          who have failed or have progressed on a VEGF receptor inhibitor   "
203052|NCT00498979|"     RATIONALE: Sodium stibogluconate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor     cells and slow the growth of melanoma and other cancers. Drugs used in chemotherapy, such as     cisplatin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving sodium     stibogluconate and interferon alfa-2b together with combination chemotherapy may kill more     tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of sodium     stibogluconate when given together with interferon alfa-2b, cisplatin, vinblastine, and     dacarbazine in treating patients with advanced melanoma or other cancer.   "
203053|NCT00498992|"     RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop an     acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor     receptor inhibitor for cancer.      PURPOSE: This clinical trial is studying how well Regenecare® wound gel works in treating     rash in patients receiving cetuximab or another epidermal growth factor receptor inhibitor     therapy for cancer.   "
203054|NCT00499005|"     Intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of     postpartum haemorrhage   "
203055|NCT00499018|"     The purpose of this study is to define an improvement in patients randomized in four     different arms:      Arm 1: R-MegaCHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 1BIS: R-CHOP14x4 + R-MAD + MAD + BEAM     + ASCT; Arm 2: R-MegaCHOP14x4 + R-MegaCHOP14x2; Arm 2BIS: R-CHOP14x4 + R-CHOP14x4; Which are     different in dose dense chemotherapy + Rituximab with or without intensified high dose     chemoimmunotherapy and support of peripheral autologous stem cells.   "
203056|NCT00499031|"     This phase II trial is studying cetuximab to see how well it works in treating patients with     persistent or recurrent cervical cancer. Monoclonal antibodies, such as cetuximab, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them.   "
203057|NCT00499044|"     The investigators will compare the test-retest reliabilities of two cognitive batteries in     people with schizophrenia: Cognitive Drug Research Computerized Cognitive Assessment System     (CDR) and MATRICS Consensus Cognitive Battery (MCCB). The investigators hypothesize that     there will be a statistically significant difference in the test-retest reliabilities between     MCCB and CDR. In addition, the investigators hypothesize that each of the two batteries will     better measure certain areas of cognition. The investigators also hypothesize that scores     from both batteries will correlate with quality of life scores, and that there will be a     significant difference between the correlations of MCCB and CDR. The investigators     hypothesize there will be a significant difference in patients' self-reported tolerability     and satisfaction of the MATRICS versus CDR assessments. Lastly, the investigators hypothesize     that there will be a significant difference in the MATRICS versus CDR batteries with respect     to an administrator-rated score of practicality.      Approximately 32 subjects will enroll in the study. Following consent and eligibility     screening (visit 1) and baseline clinical assessment and training in the use of the CDR     battery (visit 2), subjects will be randomized into one of two groups for visits 3 and 4. One     group will complete the CDR and then MCCB in visit 3, as well as the Tolerability Scale for     each battery. The other group will complete the batteries in reverse order during visit 3.     Each group will complete both batteries again in reverse order for visit 4. Randomization     will be done in blocks of 2. After completion of every 4 subjects, study administrators will     complete the Practicality Scale for each battery.   "
203058|NCT00499057|"     Partial breast irradiation (PBI) is becoming more widespread in the treatment of early breast     cancer in patients at low risk of relapse as pathological and clinical findings have     demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed. In     our phase II prospective study PBI is administered with high-dose-rate brachytherapy in     patients with low-risk early-stage breast cancer. Patients receive 4 Gy twice a day for 4     days (total dose 32 Gy).   "
203059|NCT00499070|"     RATIONALE: Studying biopsy, bone marrow, and blood samples from patients with cytopenia that     did not respond to treatment may help doctors learn more about the disease and plan the best     treatment.      PURPOSE: This laboratory study is assessing immune function in young patients with cytopenia     that did not respond to treatment.   "
203060|NCT00499083|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, cyclophosphamide, and doxorubicin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Injecting the patient's dendritic cells directly into the tumor     may stimulate the immune system and stop tumor cells from growing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Estrogen can cause the growth of breast cancer cells.     Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by     the tumor cells. Giving combination chemotherapy together with autologous dendritic cells     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs     to be removed. Giving radiation therapy and hormone therapy after surgery may kill any tumor     cells that remain after surgery.      PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel     together with cyclophosphamide and doxorubicin followed by autologous dendritic cells and     surgery with or without radiation therapy and/or hormone therapy works in treating women with     stage II or stage III breast cancer.   "
203061|NCT00499096|"     The purpose of this research study is to learn whether or not people with bipolar disorder     can reduce their risk of heart disease and related conditions by having a Care Manager     provide self management and care management.   "
203062|NCT00499109|"     This is a clinical research study to evaluate if chemotherapy in the experimental arm (E)     results in a better outcome compared to patients in the standard of care arm (C).      2:1 randomization to experimental arm (E) or standard arm (C). In arm E, treatment of     dual-agent chemotherapy will be selected based on RRM1 and ERCC1 expression at the protein     level. In arm C, treatment of dual-agent chemotherapy will be gemcitabine/carboplatin, i.e.,     standard of care.   "
203090|NCT00499486|"     RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well sirolimus works in treating patients with     advanced pancreatic cancer.   "
203063|NCT00499122|"     RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways     and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin,     cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) may kill more tumor cells. Giving NOV-002 together with     chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed.      PURPOSE: This phase II trial is studying how well giving oxidized glutathione (NOV-002)     together with doxorubicin and cyclophosphamide followed by docetaxel works in treating women     with newly diagnosed stage II or stage III breast cancer.   "
203064|NCT00499135|"     This phase I trial is studying the side effects and best way to give sunitinib malate in     treating patients with unresectable or metastatic kidney cancer or other advanced solid     tumors. Sunitinib malate may stop the growth of tumor cells by blocking blood flow to the     tumor and by blocking some of the enzymes needed for cell growth.   "
203065|NCT00499148|"     The purpose of the study was to evaluate the effect of an herbal extract on postprandial     glycemia following a meal.   "
203066|NCT00499161|"     The purpose of this randomized clinical trial is to examine the effect of Patient-Centered     Care (PCC) on a patient's level of satisfaction on discharge from an acute healthcare     setting. Findings from this study will assist in determining if PCC, administered by nurses,     should be instituted hospital wide.      SPECIFIC AIMS:        1. To examine the effect of Patient-Centered Care on patient satisfaction.        2. To examine the effect of Patient-Centered Care on the quality of patient care.        3. To examine the effect of patient's perception of nursing care on patient satisfaction.   "
203067|NCT00499174|"     RATIONALE: Sometimes prostate tumours may not need treatment until they progress. In this     case, observation may be sufficient. Radical treatments, such as radical prostatectomy or     radiation therapy, may be effective in treating prostate cancer when it is first diagnosed.     It is not yet known whether active surveillance is more effective than radical treatment as     an initial intervention in favorable prognosis prostate cancer.      PURPOSE: This randomized phase III trial is studying active surveillance to see how well it     works compared with radical treatment as an initial intervention in patients with favorable     prognosis prostate cancer.   "
203068|NCT00499187|"     Cross-sectional cohort study of participants with HIV with or without protocol-defined     Fanconi syndrome (confirmed creatinine clearance [CLcr] decline and evidence of proximal     tubulopathy).   "
203069|NCT00499200|"     The study will include a preliminary pharmacokinetics (PK) / safety / tolerability evaluation     in healthy elderly subjects followed by the Receptor Occupancy (RO) evaluations in healthy     elderly subjects and in Alzheimer's Disease (AD) subjects.   "
203070|NCT00499213|"     We have developed and implemented a program that offers home care assistance to patients     wishing to perform home peritoneal dialysis, but are unable to do it for themselves. This     study is being conducted to ensure the safety of this dialysis program and specifically, to     see if the risk of being hospitalized is increased when this therapy is provided to patients.   "
203071|NCT00499239|"     Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult     patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the study     in sequential dose cohorts.      Patients will be administered a single IV infusion of GS 9219 on Day 1 of a 21 day cycle and     may receive a total of six treatment cycles based on toxicities and response. Patients who     demonstrate disease progression will be discontinued from the study. Patients who, at the     completion of six treatment cycles, tolerate treatment and show evidence of disease control     (response or stabilization) will be eligible to continue receiving treatment at the same     dose.   "
203072|NCT00499252|"     This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized     nanoparticle formulation works in treating patients with recurrent or persistent ovarian     epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in     chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing.   "
203073|NCT00499265|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     WX-671 may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving gemcitabine together with WX-671 may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well gemcitabine works when given     together with WX-671 or when given alone in treating patients with locally advanced     pancreatic cancer that cannot be removed by surgery.   "
203074|NCT00499278|"     1. What are the characteristics of joint replacement patients (DRGs 209 & 210) served in          IRFs and SNFs? How are they similar or different?        2. How are the interventions and processes of care for joint replacement patients different          in IRFs and SNFs?        3. What specific interventions or combinations of interventions in IRFs and SNFs make the          biggest difference in outcomes for joint replacement patients taking into account          patient differences?        4. Which joint replacement patients do better in an IRF and which do better in a SNF?        5. What is the relative cost-effectiveness of IRF and SNF care for joint replacement          patients?        6. Are comorbidities among joint replacement patients an adequate indicator of additional          medical need during the rehabilitation process? Can a severity-of-illness measure serve          as a better indicator of medical need? Are patients with greater medical needs served          better in an IRF or a SNF?        7. Can we design a more efficient course of rehabilitation interventions for joint          replacement patients in IRFs and SNFs to reduce the length of stay and costs?   "
203075|NCT00499291|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.      PURPOSE: This clinical trial is studying how well paclitaxel albumin-stabilized nanoparticle     formulation works in treating patients with advanced or refractory solid tumors.   "
203076|NCT00499304|"     The aim of this study is to distinguish COPD patients with expiratory flow limitation in body     plethysmography (open loop) from the patients without expiratory flow limitation in body     plethysmography (closed loop) with the obtained FOT parameters.   "
203077|NCT00499317|"     Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a condition with several causes     of which some remain unknown. It is believed that some types of CP may be genetic or passed     down (inherited) from one generation to the next.      In this study, we are collecting genetic material and medical information to try to determine     if there are genetic factors may play a role in CP/CPPS. We will be collecting DNA (from     Saliva) and urine from each participant. Individuals and families with CP/CPPS will be     enrolled. Family members of an individual with CP/CPPS are eligible whether or not they also     experience CP/CPPS symptoms.   "
203078|NCT00499330|"     RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than     lobectomy for non-small cell lung cancer and may have fewer side effects and improve     recovery. It is not yet known whether wedge resection or segmentectomy are more effective     than lobectomy in treating stage IA non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying different types of surgery to compare     how well they work in treating patients with stage IA non-small cell lung cancer.   "
203079|NCT00499343|"     Primary Objectives:        1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups.        2. To determine the number of apheresis procedures, total stem cell yield/kg patient body          weight and the toxicity profile in the two groups.      Secondary Objectives:        1. To determine the degree of expression of various adhesion molecules in the 2 groups and          correlate with time to engraftment of neutrophils, platelets, and red blood cells,          efficacy of stem cell mobilization and purging.        2. To determine the incidence of disease progression/relapse at 12 months in the two          groups.   "
203080|NCT00499356|"     We evaluated the feasibility of the GlideSoft™ novel insole to reduce pressure and shear     forces on the foot. No commercially available insoles are designed to reduce shear. Although     insurance providers spend millions on diabetics’ therapeutic insoles, there is no scientific     data about shear or pressure reduction. We will evaluate the optimal bonded materials from     Phase I compared to the Glidesoft™ design using the same combination of viscoelastic     materials. We evaluate 2 patient groups of 150 patients per arm (300 total) in an 18 month     trial. The control group patient arm wore a traditional bonded insole whereas another the     second arm receive the GlideSoft™. At baseline, and at the end of the 18 month trial, in-shoe     gait lab and in vitro biomechanical parameters measured pressure, shear, and material     properties as these changed with wear. This Phase II eighteen (18) month clinical trial     evaluated the effectiveness of ShearSole™ reducing the incidence of diabetic ulcers. The     overall study hypothesis was that GlideSoft™ provides significant shear reduction as compared     to traditional insoles without sacrificing pressure reduction characteristics or durability.   "
203081|NCT00499369|"     This randomized phase III trial is studying giving irinotecan and cetuximab together with     bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in     treating patients with metastatic colorectal cancer that progressed during first-line     therapy. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether     irinotecan and cetuximab are more effective with or without bevacizumab in treating     metastatic colorectal cancer.   "
203112|NCT00505934|"     Keppra injection is approved in the US as adjunctive therapy in the treatment of partial     onset seizures in adults with epilepsy. The objective of the current study is to assess the     safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4     years.   "
203083|NCT00499395|"     RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET imaging, may be effective     in detecting residual disease after radiofrequency ablation of liver metastases in patients     with colorectal cancer.      PURPOSE: This clinical trial is studying fludeoxyglucose F 18-PET imaging to see how well it     works for early detection of residual disease in patients undergoing radiofrequency ablation     of liver metastases from colorectal cancer.   "
203084|NCT00499408|"     RATIONALE: Vitamin D and soy extract may be effective in lowering prostate-specific antigen     (PSA) levels in patients with recurrent prostate cancer that has not responded to previous     treatment.      PURPOSE: This phase II trial is studying how well giving vitamin D together with soy     supplements works in treating patients with recurrent prostate cancer.   "
203085|NCT00499421|"     The goal of this clinical research study is to evaluate a system for localizing (targeting     for treatment) the prostate for external beam radiation therapy. The system will be used to     locate the prostate before treatment and to measure movement of the prostate during     treatment. The data collected with the system will be compared to CT images taken during the     course of your radiation therapy treatment. Researchers will try to use this information to     verify the performance of the system, which could lead to improved positioning and tracking     of the prostate during treatment.   "
203086|NCT00499434|"     This study aims at correlating TNF-α, INF-γ, IL-2, IL-4, IL-10 and TGF-β values as dosed by     ELISA and mRNA expression by real-time PCR with histopathological hepatic biopsy findings in     individuals with HIV/HCV coinfection. This population will be divided into three groups (G1:     with no HAART; G2: with detected HIV viral load (HIV VL); G3: with undetected HIV VL), which     will be then compared to two control groups with monoinfection by HIV or by HCV, in addition     to a third control group comprising normal blood donors.   "
203087|NCT00499447|"     RATIONALE: Radiofrequency ablation uses a high-frequency electric current to kill tumor     cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Giving     radiofrequency ablation together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving radiofrequency ablation together     with external-beam radiation therapy works in treating patients with stage I non-small cell     lung cancer that cannot be removed by surgery.   "
203088|NCT00499460|"     RATIONALE: Garlic supplements may alter the pharmacokinetics of oxycodone, thereby affecting     its effectiveness as an opioid analgesic for the relief of moderate or severe pain.      PURPOSE: This randomized phase 4 trial is studying how garlic supplements may change the     pharmacokinetics of oxycodone and its analgesic and side effects in healthy volunteers.   "
203091|NCT00499499|"     The purpose of this study is to investigate E7107 in patients with solid tumors. This is an     open label, dose-escalation study of E7107. The maximum tolerated dose (MTD) of the single     agent will be established by determining the occurrence of dose limiting toxicities during     the first three weeks of therapy (Cycle 1). Patients in this study will be treated at     multiple dose levels, starting at 0.6 mg/m^2. Patients will receive E7107 as a 30-minute     intravenous infusion on Days 1 and 8 every 21 Days.   "
203092|NCT00499512|"     The goal of this psychosocial research study is to examine and explain the influence of     spirituality on patients with ovarian, primary peritoneal or fallopian tube cancer.   "
203093|NCT00499525|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. Giving paclitaxel together with sorafenib may     kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well paclitaxel works when given     together with or without sorafenib in treating patients with locally recurrent or metastatic     breast cancer.   "
203094|NCT00499538|"     To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a     reference capsule and an oral solution in healthy subjects.   "
203095|NCT00499551|"     The multiple properties of the corticosteroids over the inflammatory response, make them     first line drugs for the treatment of several ocular inflammatory disorders of different     etiologies. In order to diminish the corticosteroids severe systemic adverse effects, the     local administration is preferred. Iontophoresis already has been used in a successful way     for the administration of corticosteroids. Clinical or histopathological injuries due to the     use of transcleral CCI have not been observed. being successful the administration of     methylprednisolone by means of this system in previous studies. The objective is to evaluate     the tolerance, security and effectiveness of this treatment, using a new generation device.   "
203096|NCT00499577|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells. Drugs used in chemotherapy use different ways to stop cancer cells from     dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by     stopping blood flow to the cancer. A stem cell transplant using stem cells from the patient     may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer     cells. Giving an infusion of the donor's T cells after the transplant may help destroy any     remaining cancer cells.      PURPOSE: This phase I/II trial is studying the side effects of stem cell transplant given     together with chemotherapy and biological therapy and to see how well it works in treating     patients with high-risk or refractory multiple myeloma.   "
203097|NCT00499590|"     The purpose of this study is to compare the safety and effectiveness of bevasiranib given     either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of     Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with     wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three     treatments options for 104 weeks.   "
203098|NCT00499603|"     The goal of this clinical research is to learn if RAD001 given in combination with     chemotherapy will turn off the signaling pathway (a chain of information that tells cancer     cells to grow quickly) and make the chemotherapies given on this study more effective.      Primary Objective      · To determine if the addition of an mTOR inhibitor to standard neoadjuvant chemotherapy in     patients with triple receptor-negative breast cancer causes molecular changes     (inhibition/activation) of the PI3K/PTEN/AKT pathway.      Secondary Objectives        -  To evaluate pathologic complete response (pCR) rates for each treatment group.        -  To evaluate the relationship between pCR and the molecular changes          (inhibition/activation) of the PI13K/PTEN/AKT pathway in each treatment group.        -  To evaluate overall response rates (ORR) for each treatment group.        -  To assess the toxicity of both regimens and to evaluate the relationship of toxicities          with PI3K/PTEN/AKT pathway status.   "
203099|NCT00499616|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and     doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma     cells become more like normal cells, and grow and spread more slowly. Giving combination     chemotherapy before surgery may make the tumor smaller and make it more likely that the tumor     can be surgically removed. It is not yet known what is the minimal amount of chemotherapy     needed to achieve sufficient tumor shrinkage to control intermediate risk neuroblastoma and     prevent tumor recurrence or metastases.      PURPOSE: This phase III trial is designed to reduce therapy for patients with favorable     biology intermediate risk neuroblastoma by decreasing the number of chemotherapy cycles     administered and by allowing for up to 50% residual tumor volume for patients with localized     disease.   "
203100|NCT00499629|"     The primary purpose of the study is to evaluate the safety of FXR-450 in healthy subjects.     This study will also evaluate pharmacokinetics (PK) of FXR-450 in healthy subjects.   "
203101|NCT00499642|"     This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled,     4-period crossover study.   "
203102|NCT00499655|"     RATIONALE: Erlotinib hydrochloride and celecoxib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of     lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with     celecoxib may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well giving erlotinib hydrochloride     together with celecoxib works compared with erlotinib hydrochloride alone in treating     patients with stage IIIB-IV non-small cell lung cancer.   "
203103|NCT00499668|"     RATIONALE: Antiemetic drugs, such as aprepitant and ondansetron, may help lessen nausea and     vomiting caused by opioids. It is not yet known whether aprepitant is more effective than     ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.      PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works     compared to ondansetron in treating nausea and vomiting caused by opioids in patients with     cancer.   "
203132|NCT00506194|"     We designed this prospective, randomized control study to compare the benefits between the     insulin therapy and OADs after correction of the glucose toxicity with a short period of     intensive insulin therapy.   "
203104|NCT00499681|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by lowering the amount of estrogen the body makes.     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving letrozole together with lapatinib before surgery may make the tumor smaller     and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This randomized phase II trial is studying how well giving letrozole together with     lapatinib works in treating postmenopausal women with stage I, stage II, or stage III breast     cancer that can be removed by surgery.   "
203105|NCT00499694|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such     as satraplatin, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving satraplatin together with bevacizumab may     kill more tumor cells.      PURPOSE: This clinical trial is studying how well giving satraplatin together with     bevacizumab works in treating patients with metastatic prostate cancer previously treated     with docetaxel.   "
203106|NCT00499707|"     The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment     with rosiglitazone/metformin will safely and effectively control glycemia as first line oral     therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate     superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.   "
203107|NCT00499720|"     The primary objective of this program is to provide expanded access to aztreonam lysine for     inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis     (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at     risk for disease progression.   "
203108|NCT00499733|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with     cryoablation may kill more cancer cells.      PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with     cryoablation works in treating patients with advanced or metastatic epithelial cancer.   "
203109|NCT00499746|"     This research is part of a set of studies whose purpose is to test whether tramadol can be     used for the treatment of opioid addiction. Tramadol is already available in the United     States as a pain medicine marketed as Ultram. It has effects similar to morphine, and it may     also have effects similar to other drugs like stimulants. The doses of tramadol used in this     study are higher than those generally used for the treatment of pain. To be in this study a     participant must be a user of opioids (drugs like heroin) and stimulants (drugs like     cocaine), but cannot be addicted to either. The person must be between 21-55 years old, and     generally healthy. Up to 12 people will take part in this study.   "
203110|NCT00499759|"     RATIONALE: An individualized exercise program may be effective in lessening fatigue and     depression and improving quality of life in patients undergoing chemotherapy for leukemia.      PURPOSE: This clinical trial is studying how well individualized exercise programs work in     patients receiving chemotherapy for newly diagnosed acute or relapsed myeloid leukemia or     lymphoblastic leukemia.   "
203114|NCT00505960|"     The purpose of this study is to assess the feasibility and efficacy of a culturally-tailored,     comprehensive behavioral intervention program specially designed for linguistically     challenged ethnic minority immigrant populations (Korean Americans) with type 2 DM.   "
203115|NCT00505973|"     This study is being conducted to assess the safety and tolerability of ascending multiple     oral doses of SCA-136 administered to healthy Japanese male subjects.   "
203116|NCT00505986|"     Determine if different genomic endometrial expression exists during embryo implantation in     obese women in comparison with non obese women.   "
203117|NCT00505999|"     Objectives:      The overall objective of this project is to identify risk factors associated with the     development of multiple myeloma (MM) by integrating epidemiologic, clinical and molecular     information. We plan to invite MDACC patients with MM, as well as controls, to participate in     this investigative case-control study. Controls will be selected from friends and spouses who     accompany patients to the various MDACC clinics and will be matched to the cases on age (±5     years), gender, and ethnicity. We will obtain demographic, risk factor and clinical     information along with a blood and buccal sample from all cases and controls. This study     could have implications for prevention and subsequent reduction in the incidence of multiple     myeloma. Collecting blood and buccal samples will allow us to study the role genetic     susceptibility plays in MM risk. The specific aims are:        1. To enroll and obtain, through self-administered questionnaires, risk factor information          on all study participants to develop detailed demographic, epidemiologic, and behavioral          profiles. This study will accrue 250 MM patients from MDACC and 250 healthy controls          selected from friends and spouses who accompany patients to the MDACC clinics. Blood (25          ml) and buccal samples will be collected from all participants.        2. To identify risk factors associated with MM by integrating epidemiological, clinical and          molecular information using a case-control approach.        3. To evaluate constitutional markers of genetic susceptibility as predictors of MM risk.          Gene-environment interactions will be explored.   "
203118|NCT00506012|"     This pilot study will evaluate the safety and efficacy of once daily T2000 when used to treat     patients with Myoclonus Dystonia over a 12 week period.   "
203119|NCT00506025|"     This study is to help determine if drinking cranberry juice can decrease risk for     asymptomatic bacteriuria (ASB). ASB occurs when there are bacteria in the urine without any     symptoms. It will also see if there is a difference in this effect between pregnant and     non-pregnant women.This research project is also designed to see what happens to bacterial     binding to the lining of the bladder after drinking cranberry juice when special problems     occur with pregnancy such as diabetes (a sugar metabolism problem) or ASB is already     occurring.   "
203133|NCT00506207|"     This study is an open-label, single center, and a dose-escalating phase I study to determine     the maximal tolerated dose and the recommended dose of S-1 combined with     irinotecan/oxaliplatin in patients with unresectable or metastatic colorectal or gastric     carcinoma.   "
203120|NCT00506038|"     Background: Calcific tendinitis of the rotator cuff may cause chronic pain at the shoulder.     Sometimes the pain can lead to a serious impairment in the daily life.      One of the most efficient treatments is percutaneous needle aspiration using ultrasound     guidance.      This treatment includes identification the tendonitis with US or screening , local anesthesia     and then puncturing the calcium in the rotator cuff many times. The treatment is short 5-10     minutes, relatively cheap ,safe and usually with good outcomes. However in the literature     there is a lack of controlled prospective trials.      Our goal is to set a study that will evaluate this treatment between two groups:        1. Puncturing the calcium in the rotator cuff 15 times (the experiment group)        2. Puncturing the calcium in the rotator cuff twice (the controlled group)   "
203121|NCT00506051|"     The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets)     to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help     control their symptoms and disease better than the chemotherapy alone.   "
203122|NCT00506064|"     Primary Objective:      To evaluate the impact of postoperative exogenous nocturnal melatonin supplementation on the     early regulation of the sleep-wake cycle and its clinical impact (subjective improvement of     the quality of sleep and reduction of cardiopulmonary events) during the first postoperative     week following anesthesia and surgery in older breast cancer patients receiving a unilateral     segmental mastectomy with or without intraoperative lymph node mapping, sentinel node biopsy     and axillary node dissection.      Secondary Objective:      To collect data and validate the Postoperative Srejic Sleep SAT Survey Questionnaire (SAT     implies relative subjective satisfaction of the patient's sleep in a scaled score out of 100     with 100 being the highest degree of satisfaction).   "
203123|NCT00506077|"     The purpose of this study is to determine the safety and effectiveness of an investigational     drug MK0249 for the treatment of the cognitive impairment in patients with schizophrenia.   "
203124|NCT00506090|"     The appearance of skin after surgery plays an important role in patient's self confidence and     life style. In fact, Keloids and hypertrophic scars are abnormal wound responses appearing in     predisposed individuals after surgery. Among different kind of lasers, used to improve the     appearance of hypertrophic scars and keloids, pulsed dye laser is now being used successfully     in treatment of scars. Pulsed dye laser is effective in improving the color, height, texture,     and elasticity of scars. Also, treatment with this technique is noninvasive, minimally     uncomfortable, and requires no anesthesia. This study will assess the efficacy and safety of     different intervals of pulsed dye laser sessions on improvement of surgical scars.   "
203125|NCT00506103|"     To investigate the safety and efficacy of the no-tie technique using the harmonic scalpel     (HS) in terms of the operating time and complications in total thyroidectomy with central     neck dissection (CND). Recently, the HS has been used as an alternative to conventional     hand-tied ligation for hemostasis in thyroid surgery, which is a time-consuming procedure.     Very limited data have been published on evidence of its safety in total thyroidectomy     accompanied by CND without supplementary hand-tied ligation.   "
203126|NCT00506116|"     The purpose of this study is to determine whether pushing during labor that is controlled by     the woman results in less birth-related injury and less postpartum urinary incontinence (UI).   "
203127|NCT00506129|"     The goal of this clinical research study is to see if receiving a transplant of blood stem     cells (cells that can produce blood) or bone marrow from either a related donor (brother,     sister or other relative) or an unrelated voluntary donor will help patients with advanced     cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain     free of disease will also be studied.   "
203128|NCT00506142|"     Marqibo (liposomal vincristine) is a form of vincristine preparation. Vincristine is designed     to interfere with the multiplication of cancer cells, which may slow or stop their growing     and spreading throughout the body. This may cause the cancer cells to die. Liposomal     vincristine is formed when vincristine is placed inside of oil droplets called liposomes,     which may help to improve the delivery of drug to the tumor site. The liposomal formulation     results in a slow, steady release of vincristine in the tumor metastasis, exposing the cancer     cells to vincristine continuously.      The goal of this clinical research study is to learn if Marqibo (liposomal vincristine) can     help to control metastatic uveal melanoma. The safety of liposomal vincristine will also be     studied.      Approximately 50 patients will take part in this study.   "
203129|NCT00506155|"     The goal of this clinical research study is to learn how well bladder cancer responds to a     combination treatment with Avastin and M-VAC (methotrexate, doxorubicin, vinblastine, and     cisplatin) before surgery to remove the tumor.      Primary Objective:      To estimate the response of patients with locally advanced urothelial cancer treated with     neoadjuvant chemotherapy with a combination of Dose Dense Methotrexate, Vinblastine,     Adriamycin, and Cisplatin (DD-M-VAC) plus Avastin followed by radical surgery with curative     intent. In this context, response will be defined as the absence of residual muscle invasive     cancer in the resected specimen (<= pT1, N0.)      Secondary Objective:      To estimate the 4-year disease-free survival of patients with locally advanced urothelial     cancer treated with neoadjuvant chemotherapy with DD-M-VAC plus Avastin followed by radical     surgery with curative intent.      Document perioperative morbidity and mortality in this cohort, with reference to     well-established historical standards.      Determine the effects of VEGF inhibition on angiogenesis and angiogenesis-related gene     expression utilizing fluorescent tissue staining techniques that we have developed in the     laboratory (such as two-color TUNEL, phospho-receptor, and microvessel density).      Interrogate downstream receptor signaling pathways to provide insight into the development of     chemotherapy resistance, and hence hypothesis for its prevention.   "
203130|NCT00506168|"     This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan     and capecitabine in previously untreated metastatic colorectal cancer.   "
203131|NCT00506181|"     Medical literature has dealt with various perspectives of probiotic therapy - prevention of     antibiotic associated diarrhoea, Clostridium difficile, etc.      However, there have been no published results which can provide a basis for a generalized     recommendation or discouragement of probiotic use among various groups of hospitalized     patients.      The hypothesis is that the benefit in probiotic therapy in the admitted patient is by far     larger than the actual cost of therapy. This assumption is probably true for all admitted     patients and for patients on antibiotic therapy in particular.   "
203136|NCT00506259|"     This study will examine the effect of bright light or melatonin treatment on sleep in     children with Smith-Magenis syndrome (SMS), a genetic disorder characterized by certain     physical, behavioral and developmental features. Patients have a disrupted sleep cycle     involving early waking, frequent daytime napping and frequent nighttime awakenings. Melatonin     is a hormone normally produced at night in healthy people. People with SMS produce high     levels of melatonin during the daytime and very low levels at night. This may affect their     behavior, mood, attention span and sleep patterns.      Healthy volunteers between 18 and 45 years of age and children with SMS who are between 3 and     16 years of age may be eligible for this study.      Healthy subjects are admitted to the NIH Clinical Center overnight. In the morning they take     one dose of time-release melatonin and have blood and saliva samples collected hourly from     7:00 AM to 6:00 PM.      Children with SMS participate in a 2-part study, as follows:      Part 1 Inpatient Trial      Pre-trial at-home phase: During the month before NIH inpatient admission, participants do the     following:        -  Wear an actiwatch device or keep a daily sleep diary to monitor daytime alertness, mood          shifts and sleep patterns.        -  Complete a behavior assessment survey related to the child s behaviors and sleep          patterns.        -  Obtain frequent body temperature measurements.        -  Collect several saliva samples over a 24-hour period.      NIH admission phase:        -  Children are admitted to the NIH Clinical Center for 2-3 nights for bright light          treatment. They remain in their rooms for alternating periods of exposure to standard          dim room light and bright light, using a light box placed within 3 to 5 feet of the          child. An electroencephalogram (EEG) with additional electrodes to track eye movements          is used to monitor the child s attention. Between 8AM and 6PM serial blood samples are          collected to measure melatonin levels. A parent rates the child s mood and behavior          during the 2-day test period.        -  Children are admitted to the NIH Clinical Center for 2-3 nights for melatonin treatment.          They take a single dose of melatonin or placebo tablet at bedtime. During the daytime,          EEG electrodes are placed to track eye movements. Between 7 PM and 7 AM serial blood          samples are collected to measure melatonin levels. A parent rates the child s behavior          and mood as described for the bright light study.        -  Children may receive either or both of the bright light and melatonin treatments.      Part 2 Outpatient Trial      Children participate in a combined bright light with melatonin trial at home. They undergo     the same procedures outlined in the pre-trial at-home phase of Part 1 (actiwatch, behavior     assessments, body temperature measurements, saliva samples) over an 11-week period. If saliva     samples cannot be collected for melatonin testing, 24-hour urine samples may be collected     instead.   "
203137|NCT00506610|"     The purpose of this study is to determine whether T-62 is effective in providing relief of     pain that can occur after an individual experiences a shingles outbreak, which is an     infection in adults caused by the same virus that causes chicken pox.   "
203138|NCT00506623|"     This study is to evaluate the pathologic complete response rate to pre-operative concurrent     chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer   "
203139|NCT00506636|"     This study is to try to maintain cultured dermal papilla cells in spherical structure in     vitro before transplanting into dermis in vivo. Also, this study is aimed in clarifying     actual mechanism of inducing hair follicle by dermal papilla cells.   "
203140|NCT00506649|"     To assess pain, agitation, and delirium experienced by critically ill patients daily and     evaluate the impact of a protocol; to compare the incidence of coma and delirium, length of     stay, mortality and costs of care between pre- and post-protocol groups.   "
203141|NCT00506662|"     This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once     daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with     type 2 diabetes naive to previous insulin therapy.   "
203172|NCT00507065|"     Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of     adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on     weight (<= 75 kg or > 75 kg).   "
203142|NCT00506675|"     This study is designed to evaluate the effectiveness of treatment of residual amblyopia in     children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The     study is a randomized clinical trial comparing intensive treatment (42 hours per week of     patching plus daily atropine) with a control group that will have rapid weaning of existing     treatment followed by spectacle correction only (if needed). The primary objective is to     determine if this intensive treatment will improve visual acuity in patients with residual     amblyopia.      The primary outcome assessment is amblyopic eye visual acuity at 10 weeks.      The primary analytic approach for the amblyopic eye acuity will be a treatment group     comparison of the proportion of patients with at least two lines of visual acuity     improvement.   "
203143|NCT00506688|"     The majority of cystic fibrosis (CF) patients die from a progressive pulmonary disease.Airway     inflammation plays a major role for the pathogenesis of CF lung disease, and ultimately leads     to lung destruction. The release of oxidants during the inflammation process leads to a     chronic imbalance of oxidants and antioxidants and may be a central component leading to     irreversible lung damage in CF patients. The antioxidant glutathione, which is a naturally     occurring tripeptide, is depleted in the extracellular epithelial lining fluid of the CF     lung. The elevation of reduced level to normal and also the augmentation of glutathione     concentrations above the normal level, as observed in smokers and during defence of     Pseudomonas infection, may be desirable to avoid lung damage. Data from pilot studies in     humans and animals have indicated that the glutathione concentrations in epithelial lining     fluid can be elevated by aerosol application.      The main objective of this trial is to evaluate the effect of a 24-week treatment with     inhaled glutathione compared with control inhalations (normal saline) on pulmonary function     in adult and pediatric CF patients. Secondary objectives are to determine the effects of     inhaled glutathione on inflammatory variables, glutathione levels and free elastase in     induced sputum and to evaluate the safety and tolerability of the 24-week treatment with     inhaled GSH.      There is considerable hope within the CF community that the addition of anti-oxidative     therapy to an already comprehensive program for treating the lungs will decrease morbidity     and improve the quality of life for patients with CF.   "
203144|NCT00506701|"     Tadalafil may lower the pulmonary artery pressure in patients with Chronic Obstructive Lung     Disease and secondary pulmonary hypertension and thereby improve patients quality of life.   "
203145|NCT00506714|"     The purpose of this study is to determine whether or not the use of a nonpharmacologic     intervention (single point cane) is effective in the treatment of knee osteoarthritis.   "
203146|NCT00506727|"     Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions     utilizing the SKAMP deportment scale.   "
203147|NCT00506740|"     the objective of this study is to determine if the use of The Harmonic™ (an ultrasonic     surgical instrument) in abdominolipectomy (tummy tuck)reduces volume and duration of wound     drainage after surgery when compared to electrocautery.   "
203148|NCT00506753|"     This study will focus on treating substance abusing incarcerated teens using individually     administered Motivational Interviewing (MI) followed by group Cognitive Behavior Therapy     (CBT). The control group receives individualized Relaxation Training (RT) followed by group     Treatment as Usual (TU). Currently, there is little research regarding effective group     treatments for incarcerated teens and this study will address this gap in our knowledge base.     We seek to reduce substance use and associated risky behaviors post-release (including     driving under the influence, risky sexual behaviors, etc.)   "
203150|NCT00506779|"     Objectives:        -  To determine the maximum tolerated dose (MTD) of imatinib mesylate in combination with          fixed dose paclitaxel in patients with stage IIIC, IV or recurrent uterine papillary          serous carcinoma.        -  To determine the nature and degree of toxicity of imatinib mesylate and paclitaxel in          this cohort of patients.        -  To determine the efficacy of imatinib mesylate and paclitaxel in patients with stage          IIIC, IV or recurrent uterine papillary serous carcinoma whose tumor expresses either          c-Kit, PDGFR or abl.   "
203151|NCT00506792|"     This study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic     response of patients with cystic fibrosis to administration of QAU145 via intranasal spray.   "
203152|NCT00506805|"     Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an     experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in     patients with cancer.   "
203153|NCT00506818|"     Cognitive and emotional symptoms are often seen in the acute phase of a stroke. The     prevalence of such symptoms later and the mechanisms explaining the symptoms are not fully     known. The causes of poststroke dementia are likely to be multifactorial (Cerebrovascular     Diseases 2006). The investigators want to include all patients with first ever stroke without     significant cognitive decline prior to the stroke (IQCODE cut-off 3,7) and follow them up for     one year. At baseline we will make stroke classifications, measure neurological deficits     according to NIHSS, evaluate cognitive and emotional function and make registrations of     vascular risk factors, including precerebral color duplex scan with measurement of IMT in     CCA. The investigators will then randomize the patients into multifactorial     vascular-risk-factor-intervention in the hospital or care as usual in the primary health     care. 8-12 months after stroke onset, survivors will undergo new examinations to evaluate     neurological, cognitive and emotional functions, as well as MRI and SPECT.   "
203168|NCT00507013|"     The QuickClose study is a prospective, non-randomized study, to evaluate the safety and     efficacy of the QuickClose device using two different dose types of heat exposure.      Patients undergoing a diagnostic angiogram procedure will be treated with the QuickClose     device. Two groups of 20 patients each, will be enrolled consecutively, Group A will complete     enrollment before enrollment into Group B begins. Patients will be monitored until 30 days     after the procedure   "
203169|NCT00507026|"     This study will compare repeated intermittent IV dosing of diclofenac in patient with     moderate to severe post-surgical pain from elective orthopedic surgery.   "
203170|NCT00507039|"     The study is meant to establish a one-step challenge with grass-pollen in patients sensitized     for grass-pollen. Therefore the investigators compare a multi-step challenge with     grass-pollen with an one-step challenge in order to survey the repeatability and safety.   "
203154|NCT00506831|"     Systemic sclerosis (SSc) is an autoimmune disease characterized by fibrosis of the skin and     internal organs and widespread vasculopathy. Patients with SSc are classified according to     the extent of cutaneous sclerosis: patients with limited SSc have skin thickening of the     face, neck, and distal extremities, while those with diffuse SSc have involvement of the     trunk, abdomen, and proximal extremities as well. The disease course varies depending on the     subtype of SSc. However, common features that result in significant morbidity and mortality,     in addition to cutaneous fibrosis, include Raynaud's phenomenon and digital ulcerations,     interstitial lung disease (ILD), and pulmonary arterial hypertension (PAH). Current     therapeutic options for patients with SSc and these clinical manifestations have shown     limited efficacy.      Imatinib antagonizes specific tyrosine kinases that mediate fibrotic pathways involved in the     pathogenesis of SSc, including c-Abl, a downstream mediator of transforming growth factor     (TGF)-beta, and platelet derived growth factor (PDGF) receptors. The efficacy of imatinib has     also been reported in the treatment of patients with refractory idiopathic PAH through its     effects on vascular remodeling. Based on the mechanism of action and preliminary patient     data, we hypothesize that imatinib may be effective in the treatment of the fibrotic and     vasculopathic features of patients with SSc. This is an open label pilot study to evaluate     the safety and efficacy of imatinib in patients with progressive SSc refractory to other     treatment(s). Validated measures of skin thickness and disease activity will be determined     over 6-months of therapy and compared with baseline measures.   "
203155|NCT00506844|"     This study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and     capecitabine concurrent with radiotherapy given preoperatively in patients with resectable     rectal cancer.   "
203156|NCT00506857|"     Objectives:        1. To determine the relative toxicities, engraftment potential, kinetics of engraftment,          degree of chimerism and disease control achieved with the combination of fludarabine and          busulfan at different dose levels and different dose schedules in patients undergoing          allogeneic stem cell transplant (SCT).        2. Determine pharmacokinetics, and toxicity of intravenous busulfan given at equal total          dose levels given four times daily, or once daily.        3. In vivo determination of fludarabine inhibitory effects on DNA repair.   "
203157|NCT00506870|"     To evaluate the benefit economic and medical of self-monitoring of coagulation compared with     conventional follow-up of anticoagulation in a population recently fitted with mechanical     heart valves.   "
203158|NCT00506883|"     This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group,     dose-comparison to determine the efficacy and safety of a standard-dose of colchicine (4.8     mg) versus low-dose colchicine (1.8 mg) or placebo for acute gout flares.   "
203159|NCT00506896|"     The purpose of this study is to compare the efficacy and safety of intra-articular     glucocorticoid injection to its systemic use for treatment of knee synovitis in patients with     Rheumatoid Arthritis   "
203160|NCT00506909|"     The objective of the study is to compare the efficacy of intranasal oxytocin versus     intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms     despite being on adequate treatment with antipsychotic medication.   "
203183|NCT00507208|"     The purpose of this study is to compare the use of the Dynasplint Trismus System to routine     trismus treatment in improving the ability of opening the mouth in a randomized trial. This     study will also determine what effects, good and/or bad, this procedure has on the     participant. Participants will be randomly assigned to the Dynasplint Trismus System or to     routine treatment with tongue depressors.   "
203161|NCT00506922|"     Primary Objective:      1. To determine efficacy of escalating doses of pentostatin in combination with tacrolimus     and methotrexate for the prevention of acute graft-versus-host disease (GVHD) in the context     of unrelated donor and one antigen mismatched related donor transplantation.      Secondary Objectives:        1. To determine safety of escalating doses of pentostatin in combination with tacrolimus          and methotrexate.        2. To reduce the incidence of acute GVHD following transplants with unrelated donor to 40%.        3. To document blood levels of tacrolimus when combined with pentostatin.   "
203162|NCT00506935|"     The purpose of this study is to find out if GVG can reduce drug use and determine safety and     effects of GVG when used together with methamphetamine. This study involves staying in the     hospital for 21 days. Participants will receive either placebo or GVG, and a limited amount     if methamphetamine will be injected on some study days. This study will enroll people that     use methamphetamine. Participants will be compensated.   "
203163|NCT00506948|"     The goal of this clinical research study is to learn if the combination of rabbit     anti-thymocyte globulin (Thymoglobulin®), sirolimus (Rapamune®), and mycophenolate mofetil     (Cellcept®) can help to prevent graft versus host disease (GVHD). The safety of this drug     combination will also be studied.      Primary Objective: To determine efficacy and toxicity of a regimen of thymoglobulin,     sirolimus and mycophenolate mofetil for prevention of acute GVHD after allogeneic stem cell     transplantation from human leukocyte antigen (HLA) identical related or unrelated donors.      Secondary Objective: To assess engraftment, chronic GVHD, relapse and survival.   "
203164|NCT00506961|"     This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration     study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with     type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with     simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is     superior to simvastatin 40 mg in achieving the combined goal of LDL-C (<100 mg/dL) and     non-HDL-C (<130 mg/dL).   "
203165|NCT00506974|"     The purpose of this study is to determine if there the impact of sleep deprivation upon     sleepiness, attention, memory, and mood is reduced by pharmacologically enhancing slow wave     sleep (SWS) with sodium oxybate.   "
203166|NCT00506987|"     This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH     486757 in subjects with chronic cough. Subjects will be randomized to receive SCH 486757 or     placebo for 14 days. After a 2-week washout period, subjects will be crossed over to the     other treatment. The primary objective is to evaluate the effectiveness of SCH 486757 in     reducing cough reflex sensitivity as determined by a challenge with capsaicin, an agent that     induces cough.   "
203167|NCT00507000|"     Tuberculosis and vitamin D deficiency are important public health problems in India. Before     the advent of effective antitubercular therapy, patients with tuberculosis were advised     treatment and rest at sanatorium where sunshine was available in plenty. There have been     reports associating vitamin D deficiency with tuberculosis in terms of incidence and     beneficial response following addition of vitamin D to antitubercular therapy. Sputum AFB     conversion rate is higher in patients with tuberculosis supplemented with vitamin D. The     present study would systematically assess role of adjunct vitamin D therapy (cholecalciferol)     in patients with pulmonary tuberculosis.   "
203173|NCT00507078|"     Recent years have witnessed major advances in the understanding of the hormonal, metabolic,     and biochemical changes that occur in obstructive sleep apnea (OSA). This project evaluates     the biomarkers that measure the most significant health impacts of this disorder and creates     a specimen bank that will facilitate evaluations of additional biomarkers in the future.   "
203174|NCT00507091|"     A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with     Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in     patients with metastatic colorectal adenocarcinoma.   "
203175|NCT00507104|"     This study performs assessments of pituitary functions by basal hormone levels in the acute     phase after TBI and/or SAH followed by detailed endocrine tests (insulin-induced hypoglycemia     or growth hormone releasing hormone-arginine-corticotropin releasing hormone-leuteinizing     hormone releasing hormone [GHRH-arginine-CRH-LHRH] test) after 4 and 12 months.   "
203176|NCT00507117|"     Patients often have difficulty sleeping during overnight sleep testing in a lab environment.     The purpose of this study is to determine if taking a sleep aid will improve sleep and     therefore the quality of the sleep study.   "
203177|NCT00507130|"     The primary objective of this study is to evaluate the safety and tolerability of escalating     multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.   "
203178|NCT00507143|"     From 100 colorectal cancer patients being treated with FOLFIRI regimen or any kind of     irinotecan containing regimen, blood samples for irinotecan and its metabolites levels and     genotypes related with its metabolism will be collected. The association of their levels and     genotypes and treatment effects will be evaluated.   "
203179|NCT00507156|"     Standard treatment of patients with acute ST-segment elevation myocardial infarction consist     of acute re-opening of the occluded coronary artery (primary PCI). Despite successful     treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final     infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies     have indicated that graded re-opening of the artery may limit tissue damage. Generally this     is referred to as mechanical postconditioning.      The study investigates the effect on final infarct size evaluated by magnetic resonance scan     of postconditioning of ST-segment elevation myocardial infarctions. Mechanical     postconditioning is performed by means of several balloon inflations in the injured vessel     following its acute re-opening.   "
203180|NCT00507169|"     The study will examine which dose of SVT-40776 is best in terms of efficacy, safety and     tolerability compared to placebo and tolterodine   "
203181|NCT00507182|"     The goal of this clinical research study is to test a new way to look for cancer and     pre-cancerous tissue changes inside the mouth.   "
203182|NCT00507195|"     The study proposes to analyze the difference in the rapidity of the recovery of post     operative cognition immediately after extubation and 20, 40 and 60 minutes post extubation     and neuropsychological complications (delirium) after 48 hours following general anesthesia     using a prospective, randomized approach. Patients undergoing any type of surgery with the     exception of cranial, cardiac or thoracic surgery can be enrolled in the study.   "
203184|NCT00507221|"     Abstract:      Over 25 million HIV-1 infected individuals are currently living in Africa and as many as     50-90% may be co-infected with soil transmitted helminths such as roundworms, hookworms or     whipworms. Helminth infection in HIV-1-infected individuals may increase HIV-1 RNA levels and     increase the rate of progression of HIV-1 to AIDS. Studies have also shown that successful     treatment of helminth co-infection (as documented by clearance of helminth eggs in stool) led     to a significant decrease in HIV-1 plasma viral load (-0.36 log10). This change in viral load     was significantly greater than that seen in those individuals without documented clearance of     their helminth co-infection (+0.67 log10) (p=0.04). Studies conducted in Africa have shown an     estimated 2.5-fold increased risk for sexual transmission of the HIV-1 for each log increase     in plasma HIV-1 viral load. In addition to direct effects on plasma viral load, the rate of     CD4 cell decline in helminth infected individuals may be directly impacted by the significant     immune activation seen with such co-infection.      The investigators propose a randomized controlled trial examining the potential benefits of     routine empiric helminth eradication in HIV-1 infected adults who do not yet qualify for     antiretroviral (ARV) therapy in Kenya. The current standard of care of symptomatic diagnosis     and treatment will be compared to a systematic empiric scheduled de-worming program for HIV     infected adults. The investigators will compare markers of disease progression including rate     of CD4 decline and changes in HIV-1 RNA levels between the two treatment arms.   "
203185|NCT00507234|"     This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled,     parallel-group, comparative study.      The objectives of this study are:        1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate          Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.        2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice          daily compared to tiotropium 18 mcg once daily.   "
203186|NCT00507247|"     Primary Objective:      Evaluate the efficacy and safety of daptomycin given for treatment of catheter-related     bloodstream infections due to S. aureus bacteria with or without exchange of the central     venous catheter (CVC) over guide wire in comparison with a historical control group of     catheter-related S. aureus bacteremia treated with standard therapy (Vancomycin) or other     active agents against staph aureus (such as beta-lactam antibiotics).   "
203187|NCT00507260|"     Primary Objective:      1. To use the results from this pilot study to estimate the effect size of the nutritional     intervention on fatigue and caloric intake.      Secondary Objectives:        1. To apply nutritional assessment tools for early detection of patients at risk for          malnutrition.        2. To examine the feasibility of conducting this intervention study.        3. To describe cancer-related fatigue patterns among BMT patients at multiple time points          during ambulatory visits.        4. To evaluate the effects of a nutritional intervention for post-allogeneic BMT recipients          on adequacy of caloric intake in order to improve cancer-related fatigue scores.   "
203188|NCT00507273|"     The goal of this observational research study is to establish a registry of information     regarding how different physicians treat and manage patients with gastrointestinal stromal     tumors (GISTs).      Objectives:        1. To describe variation in management of patients with GIST, overall and by patient and          provider characteristics.        2. To provide participating physicians with information regarding management of their          patients with GIST compared to the aggregate experience of all physicians participating          in the Registry.   "
203189|NCT00507286|"     Erectile dysfunction (ED or impotence) is a common medical condition affecting many men world     wide. The most commonly used treatment for ED are oral medications like Viagra (sildenafil),     Levitra (vardenafil) and Cialis (tadalafil). If these are not effective the use of an     injection into the penis (intracavernosal injection or ICI) is necessary. However in some men     neither of these therapies is successful.      Hypothesis: An adequate erection may be achieved in men with difficult-to-treat erectile     dysfunction, when they are treated with a therapy of combination of tablet and penile     injection, when a single treatment therapy has failed for these men.      Aim of the study is to test the safety and efficacy of a combination of Viagra and Caverjet     Impulse in a group of men who had failed to achieve an adequate response to the maximum     recommended dose of either Viagra, Cialis or Levitra and Caverjet Impulse, when these     treatments were used alone.      20 men with difficult to treat ED will be given oral medication, intracavernosal therapy or     the combination in a single-blind randomised study.      Informed consent will be signed prior to any study procedures being carried out. All     participants are 'blinded' to their study treatments. Participants who have satisfactory     response to any of the tablets or penile injections, will be excluded from the study.   "
203190|NCT00507299|"     This study aims to enhance pediatric primary care to make it more responsive to psychosocial     needs facing many families. We hypothesized that by identifying and addressing certain     problems, such as depressed mothers, parental drug use, and domestic violence, we would help     decrease child abuse and neglect.   "
203191|NCT00507312|"     This study will be testing two devices which are designed to detect cardiovascular disease in     patients as early as possible. As there are now many therapies to prevent and treat this     condition it is believed that detecting it early will help reduce the burden of the disease     and permit more effective treatment.      The two devices the investigators are testing are the ViScope developed by HD Medical and a     device developed by CSIRO. Both of these devices are simple, non-invasive and may provide     useful information on how well the heart contracts and relaxes as well as valve function of     the heart.      The investigators are planning to enroll 100 healthy subjects, 100 participants with risk     factors for heart failure and 300 patients with varying types of heart failure.      The data collected from the experimental devices will be compared to the results from     standard tests.      Patients will not have any of their therapies altered as part of this study.   "
203192|NCT00507325|"     The goal of this laboratory research study is to collect blood and tumor samples from     patients with malignant melanoma. Researchers want to store these samples in a secure and     confidential laboratory at M. D. Anderson. Researchers will use the information that is     learned in this study to help find ways to improve treatment for melanoma and other cancers.   "
203193|NCT00507338|"     ARC1779 is a novel drug being tested in patients undergoing angioplasty and stenting as their     primary treatment for heart attack.   "
203194|NCT00507351|"     The primary purpose of this study is to examine the feasibility of collecting pain and other     symptom data in outpatient treatment centers across multiple institutions in the Texas     Medical Center (TMC). We will also examine the prevalence and severity of cancer-related pain     and begin to identify other commonly reported symptoms in outpatient settings. Factors that     interfere with management of pain will also be examined. Additionally, the study will explore     patient satisfaction with pain management and pain education in outpatient settings. The     specific aims of this study include:      Primary Objective:      -Explore the feasibility of a collaborative effort by oncology nurses to collect pain and     symptom data across multiple institutions that care for ambulatory cancer patients in the     TMC.      Secondary Objectives:        -  Describe the prevalence and severity of pain and other symptoms in persons with breast,          colorectal, lung, or prostate cancer who are receiving chemotherapy in the outpatient          setting.        -  Describe factors that interfere with adequate pain management in these patients.        -  Examine patient satisfaction with pain management and patient education about pain          management.   "
203195|NCT00507364|"     Chronic anal fissure is a linear tear in the distal anal canal. Most chronic fissures require     intervention to heal. Surgical sphincterotomy is currently performed. However, the procedure     permanently weakens the internal sphincter and may be associated with permanent complications     such as incontinence. Current topical treatment or  chemical sphincterotomy is effective in     the short term for about 70% of the patient more than 50% of them will suffer from     recurrence. Number of studies support the hypothesis that local ischemia is the reason for     failure to heal in anal fissure. Treatment of refractory wounds by macrophage suspension is     an innovative method since 1995, macrophage suspensions have been used successfully in more     than 1400 patients in several hospitals in Israel without any side effect.Macrophages have     key function in almost every stage of wound healing. They help in the digestion of bacteria,     in a later stage, they secret IL-6, which influences endothelial cell proliferation and the     initiation of angiogenesis.      The study hypothesis is that local injection of activated human macrophages into chronic anal     fissure may induce fissure healing.   "
203209|NCT00507546|"     The purpose of this study is to determine if replacing melatonin function with a melatonin     agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia)     helps to alleviate self-reported sleep disruption.   "
203210|NCT00507559|"     A prospective, non-randomized, multi-center clinical study to evaluate the safety and     effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair     historical control group in the treatment of abdominal aortic aneurysms (AAA).   "
203211|NCT00507572|"     The goal of this research study is to collect information on patients who are or were     pregnant while diagnosed with cancer and to store this information in a research database.   "
203196|NCT00507377|"     Background The existence, diagnosis and treatment of short esophagus is one of the     controversies of the past which has recently re-emerged The missed diagnosis of short     esophagus and the consequent inadequacy of treatment is one of the major causes of failure of     antireflux surgery.      The daily clinical practice of surgeons dedicated to therapy of esophageal diseases could     take advantage of the definition of frequency, preoperative predictors, intraoperative     management and post operative outcomes of cases of foreshortened esophagus, in order to offer     the patient affected by GERD the elements necessary for a conscious choice of therapy and to     plan the best performance of the surgical procedure.      Aims of the Study To define the percentage of cases among the total of antireflux procedures     performed, in which, after standard isolation of the ge junction and eventual dissection of     the mediastinal esophagus at least two centimetres of esophagus can not be replaced without     any applied tension below the apex of the diaphragmatic hiatus.      To define the percentage of surgical procedures aimed to treat electively a condition of non     reducible G-E junction and foreshortened esophagus, among a multicentric formed case series     of patients submitted to antireflux surgery.      To define the preoperative clinical and instrumental predictors for a surgical procedure     aimed to treat foreshortened esophagus.      To record the intra-operative, postoperative, 6 month and 12 month outcome of procedures     adopted for the surgical treatment of GERD.      Materials and Methods The study will comprise patients in which surgical therapy for GERD is     indicated according to the international guidelines and the Centres policy .      Patients will be submitted to the antireflux procedure chosen by the surgeon according to the     internationally recognized scientific surgical principles and the personal judgement.      The preoperative study and the postoperative follow up adopted in the present study are     accepted by the Centres as they correspond to the international guidelines and the Centres'     current practice criteria for the surgical treatment of GERD.   "
203197|NCT00507390|"     This is a hypothesis testing study, the hypothesis being that dietary supplements of n-PUFAs     concentrates are anti-arrhythmic in ventricular arrhythmic substrates.      Study Aims: To investigate whether dietary supplements of n-3 polyunsaturated fatty acid     concentrates (2g PUFAs/day, Omacor) reduces MTWA (a surrogate endpoint for ventricular     arrhythmia substrate) in patients with ICDs for malignant ventricular arrhythmias.   "
203198|NCT00507403|"     There is a great individual variability of pharmacokinetic of infliximab in patients treated     for ankylosing spondylitis (AS). Moreover, some patients have a treatment with methotrexate     (MTX), others have not.      Thus, the aim of this study is to assess the effect of MTX on the pharmacokinetic properties     of infliximab in 30 patients treated for AS, 15 with MTX, 15 without.   "
203199|NCT00507416|"     This is a randomized, open label, multicenter clinical trial to compare the efficacy and     safety of Velcade (bortezomib) and dexamethasone versus Velcade, thalidomide, and     dexamethasone versus Velcade, melphalan, and prednisone in patients with previously untreated     multiple myeloma not considered candidates for high-dose chemotherapy and autologous stem     cell transplantation.   "
203200|NCT00507429|"     The purpose of the study is to determine the safety and efficacy of combretastatin combined     with paclitaxel and carboplatin in the treatment of anaplastic thyroid cancer (ATC).   "
203201|NCT00507442|"     The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with     VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone,     cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no     prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and     Dexamethasone will increase the complete response (CR)/ very good partial response (VGPR)     rate.   "
203202|NCT00507455|"     A study to evaluate the safety of the co-administration of solifenacin succinate with     tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet     obstruction (BOO).   "
203203|NCT00507468|"     The object of this open-labeled, uncontrolled pilot study was to investigate the safety and     feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the     myocardium using the helical needle transendocardial (TE) delivery system in stable coronary     patients with ventricular dysfunction due to chronic myocardial infarction (MI).      A secondary goal was to assess the possibility that such cell injections could improve     ejection fraction (EF).   "
203206|NCT00507507|"     The main objective of the study was to evaluate the antiviral activity of tenofovir     disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF     combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the     immune tolerant phase of HBV infection.      The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was     evaluated for suppression of the virus (decrease in HBV DNA), serological response     (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and     the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF     monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events     and changes in laboratory parameters.      Participants were randomized in a 1:1 ratio to receive tenofovir DF monotherapy or FTC plus     tenofovir DF. All subjects were to continue on blinded study medication until the last     subject reached Week 192. Participants who permanently discontinued study drug (on or before     Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of     alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or     after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to     antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their     regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject     reached Week 192.   "
203207|NCT00507520|"     To assess the effects of almonds on coronary heart disease (CHD) risk factors (serum lipids,     measurements of oxidative stress and nitric oxide production) when added to the diets of     subjects with high cholesterol. Also, to assess whether the amount of almonds consumed (i.e.     almond dose) decreases CHD risk factors in a dose dependent manner. We hypothesize that since     almonds have been shown to reduce serum lipids, we believe they will also increase nitric     oxide levels related to their high levels of arginine and reduce markers of oxidative stress     related to their content of bioactive phenolics. We anticipate that a dose-dependent     relationship will be observed resulting in greater reductions in risk factors for coronary     heart disease when greater doses of almonds are consumed.   "
203208|NCT00507533|"     The purpose of this study is to evaluate the use of CPAP in the prevention of acute     respiratory failure in neutropenic ( or hematologic malignancy ) patients .CPAP applied     preventively in hematological patients with high risk of ARF may reduce:need for intubations     and mechanical ventilation, incidence of pneumonia and sepsis,mortality,length of ICU and     hospital stay   "
203212|NCT00507585|"     PRIMARY:        -  To determine the toxicity and tolerability of intra-arterial hepatic oxaliplatin every          three weeks administered in combination with systemic intravenous Fluorouracil,          Leucovorin and bevacizumab to patients with advanced solid tumors metastatic to the          liver.      SECONDARY:        -  To document in a descriptive fashion the antitumor efficacy of this combination regimen.        -  To evaluate the feasibility and accuracy of an alternate radiographic assessment tool          and compare with available tumor markers and RECIST guidelines.        -  To estimate in a descriptive fashion the development of extrahepatic tumor recurrences.   "
203213|NCT00507598|"     The purpose of this study is to collect specimens to perform metabolic profiling of serum and     urine from patients with colorectal cancer, colon polyps and healthy patients.   "
203214|NCT00507611|"     The purpose of the present proposed clinical trial will be to assess the utility of SLN     mapping and biopsy for predicting the final axillary status after completion of preoperative     neoadjuvant systemic chemotherapy in patients who had biopsy-proven positive axillary lymph     nodes at initial presentation   "
203215|NCT00507637|"     The objective of this Phase II study is to show that pre-treated patients with BEB with the     need of shortened injection intervals achieve an improved and stable quality of life level if     they receive repeated NT 201 injections at short injection intervals. In addition, the     tolerability of repeated shortened NT 201 administrations in patients with BEB including the     development of neutralizing antibodies will be investigated.   "
203216|NCT00507650|"     The purpose of this study is to determine whether providing extra fluid to nursing home     residents will help prevent or heal pressure ulcers. We hypothesize that providing extra     fluid to nursing home residents will increase their skin blood flow and oxygen to support     healing and maintaining healthy skin. Participants are enrolled who have a pressure ulcer or     who are at-risk for an ulcer (determined by looking at risk factors). The study is divided     into two 10 day phases. In Phase 1, we examine participant's usual status, including fluid     intake and baseline healing potential. In Phase 2, participants are randomly placed in groups     to receive either their usually prescribed fluid intake or additional fluid. A study nurse     provides the fluid to the residents. We measure their actual intake, their body water, how     well their kidneys are working, their potential to heal, and also monitor them for the     development of fluid overload. This study is important because it helps us understand the     role of a basic nursing intervention in the prevention and treatment of pressure ulcers.   "
203217|NCT00507663|"     This study proposes a prospective randomized study of elders undergoing elective major     abdominal surgery to assess recovery following a unique anesthetic regimen incorporating a     adrenergic receptor antagonist. The purposes of this study are to:        1. to determine if using atenolol, a beta-blocker drug commonly used to treat high blood          pressure and heart disease, as part of your anesthetic regimen will decrease          complications that sometimes occur in elderly patients who are undergoing surgery and          being given anesthesia.        2. to see if it improves or quickens your recovery from anesthesia and surgery.        3. to help investigators design better ways to administer anesthesia during surgery,          especially in elderly patients, so that the complications and the time to recover from          surgery and anesthesia can be decreased.   "
203255|NCT00508157|"     258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or     quetiapine in the treatment of schizophrenia and currently presenting with metabolic     syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a     range of 10 to 30 mg once daily (QD); or ii) continue for 16 weeks on the same atypical     antipsychotic treatment prior to the study enrollment.   "
203256|NCT00508170|"     Primary Objectives:        1. To determine whether high-risk sexual behaviors are more common in patients with          oropharyngeal cancer than in patients with head and neck cancers of other sub-sites.        2. To determine if high-risk sexual behaviors are more common in patients with HPV (human          papillomavirus) associated head and neck cancer than those without evidence of HPV-16          infection.   "
203218|NCT00507676|"     Infants will be enrolled into this study in one of three groups. First, there will be a group     of full term infants with no history of wheezing. Second, there will be a group of infants     receiving a ct scan that is non-respiratory related. Third, there will be a group of infants     that are born full term but have a history of wheezing of at least 3 episodes. The three     groups will be compared to see if there is a difference in lung function, lung structure and     lung size. Besides comparing the testing results we will be evaluating environmental and     inherited characteristics. There are 2 purposes of this study. The first purpose is: To     determine whether asymptomatic groups of infants at high risk for wheezing (Environmental     tobacco smoke (ETS) exposure, Fm Asthma, male Gender) have fixed or reversible airway     narrowing. The second purpose of this study is: To determine the relative contributions of     fixed and reversible airway narrowing in infants with recurrent symptomatic wheezing, and to     determine whether fixed and reversible airway narrowing is related to ETS exposure, Fm     Asthma, and male Gender.   "
203219|NCT00507689|"     The objective of this 96-week study was to evaluate the safety and antiviral efficacy of     emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without     hepatitis B immunoglobulin (HBIg) in preventing the recurrence of chronic hepatitis B     following liver transplantation, in participants who were chronically infected with hepatitis     B prior to transplantation.      Prior to enrollment, participants were required to have received at least 12 weeks of HBIg     therapy following liver transplantation. Enrolled participants then received FTC/TDF plus     HBIg for an initial 24-week pre-randomization treatment period. Participants who completed     the pre-randomization period and who achieved sustained viral suppression were randomized to     continue treatment with FTC/TDF with or without HBIg for an additional 72 weeks (randomized     period). The antiviral efficacy of treatment was assessed by measuring hepatitis B virus     levels in the blood (HBV DNA). Safety and tolerability was monitored by assessing adverse     events and various laboratory parameters.   "
203220|NCT00507702|"     To identify unique blood markers in cancer patients so that we can identify patients with     evidence of pre-existing immunity who may be a responder to immunotherapy.   "
203221|NCT00507715|"     The purpose of this trial is to study the effect of the association levodopa/carbidopa with     plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being     treated with levodopa/carbidopa.   "
203222|NCT00507728|"     The goal of this behavioral research study is to learn more about how the drugs Bupropion and     Varenicline affect mood and physiological responses in different groups of people as they     attempt to quit smoking. Researchers want to learn how these drugs affect responses related     to changes in emotion and whether or not a person's genetic make-up makes a difference in how     they respond to the medication.   "
203223|NCT00507741|"     This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in     participants with advanced ovarian and endometrial cancers.   "
203235|NCT00507897|"     The purpose of this study is to determine the relationship of hemodynamic parameters with the     level of thyroid hormones and the histological structure of thyroid nodules in euthyroid     patients.   "
203224|NCT00507754|"     Primary Objective:      1. To evaluate the performance of the new T-SPOT.TB test and the conventional TST for     screening of Latent Tuberculosis infections in patients with cancer and those undergoing     Hematopoietic Stem Cell Transplant.      Secondary Objectives:        1. To examine the factors associated with positive response to T-SPOT.TB and the TST          (tuberculin skin test) in patients with anergy.        2. To determine the impact of immunosuppressive and antineoplastic therapy on the screening          performance of T-SPOT.TB and the TST in cancer patients.   "
203225|NCT00507767|"     This phase II trial studies how well dasatinib works in treating patients with head and neck     cancer that has come back or spread to other areas of the body. Dasatinib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth.   "
203226|NCT00507780|"     This study will examine whether the drug cetrorelex acetate (Cetrotide[Registed Trademark])     can protect ovarian function in women undergoing chemotherapy. Some cancer treatments are     known to cause a change in women's periods or to cause menstruation to stop completely, so     that they cannot become pregnant. Cetrorelex acetate has been used for many years to lower     hormone levels and stop periods in patients undergoing in vitro fertilization treatments.     This study will see if making the ovaries inactive may protect them from being affected by     certain cancer drugs, and thus preserve fertility.      Women up to age 21who have begun menstruating, who have their uterus and at least one     functioning ovary, and who are undergoing chemotherapy with cyclophosphamide, busulfan,     nitrogen mustard or L-phenalanin mustard may be eligible for this study.      Participants undergo the following procedures during this 24-month study:      Baseline evaluation        -  Medical history, physical examination and blood and urine tests        -  Questionnaire about quality of life, menstrual periods, vaginal bleeding and desire for          future fertility        -  3D ultrasound of abdomen        -  DEXA scan to evaluate bone density      Assignment to treatment with:        -  Lo ovral (contraceptive pill to prevent pregnancy and control menstrual periods) alone,          or        -  Lo ovral and the study drug cetrorelex acetate, given as an injection under the skin          once a day for six menstrual cycles      Evaluations        -  Transvaginal 3D ultrasound to monitor changes in the ovary - after 6 months of          cetrorelex acetate injections        -  DEXA scan - after 6 months of cetrorelex acetate injections        -  Blood tests for safety monitoring, pregnancy testing, endocrine tests and research uses          - every 3 months during first year, every 6 months during second year        -  Questionnaire to monitor changes and quality of life - every 3 months during first year,          every 6 months during second year.   "
203227|NCT00507793|"     To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly     with a fixed dose of sirolimus in kidney transplant recipients.   "
203228|NCT00507806|"     The study is designed to examine the safety, tolerability, and activity of a combination of     microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz     transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen     activator (tPA) treatment in subjects with acute ischemic stroke.   "
203229|NCT00507819|"     In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance     in patients with a single cardiac ventricle who have undergone the Fontan operation. The     investigators will also evaluate echocardiographic measures of ventricular function and     measure quality of life changes using two validated quality of life measures. The hypothesis     is that sildenafil will result in increased exercise tolerance in patients who have had the     Fontan operation as compared to placebo.   "
203257|NCT00508183|"     The study will identify if there is a difference of quality of life after surgery between two     techniques used in surgery. The two different techniques are either the Single Row Fixation     or the Double Row Fixation.   "
203323|NCT00509041|"     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with     previously treated malignant mesothelioma.   "
203230|NCT00507832|"     The development of the topical calcineurin inhibitor pimecrolimus resulted in a significant     improvement in the treatment of atopic dermatitis. In addition, an excellent amelioration of     pruritus could be regularly observed. Up to now, several itchy dermatoses such as chronic     irritative hand dermatitis, rosacea, graft-versus-host-disease, lichen sclerosus, prurigo     simplex, scrotal eczema, and inverse psoriasis were reported as single cases also to respond     to a pimecrolimus treatment.      In prurigo nodularis, pruritus is the main symptom and it is of immediate importance to find     an effective antipruritic therapy. Pruritus is regularly severe and therapy refractory to     topical steroids or systemic antihistamines. Capsaicin cream is one effective possibility to     reduce the itch in these diseases. However, it has to be applied 3 to 6 times daily, rubs off     on the clothing and induces burning in erosions. In addition, since no commercial preparation     is available, it has to be prescribed in several concentrations. The application of     pimecrolimus seems to be promising since it has to be applied twice daily only. Especially in     prurigo nodularis we expect a good response as we could demonstrate in single patients.     Furthermore it has been published recently that Tacrolimus, another calcineurin inhibitor has     been successfully used in the treatment of six patients with prurigo nodularis.      This study is designed to compare the efficacy and safety of pimecrolimus 1% cream and     hydrocortisone 1% cream in prurigo nodularis and to investigate the mode of action of the     antipruritic effect of the drugs.   "
203231|NCT00507845|"     Primary:        -  To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients      Secondary:        -  To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.   "
203232|NCT00507858|"     Primary Objective:        -  To determine the maximum tolerated doses (MTDs) of pemetrexed when given with          dexamethasone. (Please note: One of the three treatment groups will not receive          dexamethasone)      Secondary Objectives:        -  To assess dose limiting toxicity (DLT), which is defined as grade 4 neutropenia > 7 days          duration, neutropenic fever, grade 4 thrombocytopenia, or any grade 3 or 4          non-hematologic toxicity excluding nausea/vomiting and excluding grade 3 transaminase          toxicity.        -  To determine objective response rate, as defined as complete response (CR) or partial          response (PR), confirmed by 2 CT scans at least 6 weeks apart in patients treated with          pemetrexed as a single agent with advanced squamous cell carcinoma of the head and neck.   "
203233|NCT00507871|"     Cryptosporidium is an intestinal parasite that causes diarrhea in children and adults. In     addition to infection of the stomach, this parasite can infect the respiratory system causing     a cough and/or problems breathing. This study will enroll 480 children between the ages of 9     and 36 months who come to Mulago Hospital for treatment of diarrhea. Researchers believe a     large number of children with diarrhea and cough will have the parasite present in their     sputum (mucus coughed up). Researchers also believe that children who have respiratory tract     cryptosporidiosis may have a cough, increased number of breaths per minute, and/or a lower     oxygen level. Blood, stool, saliva, and sputum samples will be collected from all children in     the study and tested for Cryptosporidium. Children too young to provide a sputum sample will     have a tube placed to collect a mucus sample from the lungs. Study participation may be as     short as 4 hours or as long as 2 days depending on each child's health.   "
203234|NCT00507884|"     The goal of this clinical research study is to find out if 3 Tesla MRI is as good as CT     scan in the evaluation of kidney tumor(s).      Objectives:      To provide preliminary data to enable subsequent development of an MRI protocol at 3 Tesla     for evaluation of renal tumors and their vascular supply, which can be adopted in patients     who are unable to undergo CT evaluation.   "
203236|NCT00507910|"     In this study we are trying to determine the incidence of flat foot (also called pes planus)     among patients who have had an ankle fracture. As compared to the general population, it is     predicted that the incidence of pes planus will be higher among people who have fractured     their ankle.   "
203237|NCT00507923|"     The goal of this behavioral research study is to learn if participating in a Tibetan yoga     program helps to improve quality of life for women during treatment for or recovery from     breast cancer. Researchers are also interested in whether the yoga program helps to improve     sleep, lung function, and physical therapy, based on outcomes.   "
203238|NCT00507936|"     This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules)     administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine     60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study     at approximately 50 sites in both the United States and Europe. The study will be divided     into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an     8-week Treatment Period and a 1-week Follow-up Visit.   "
203239|NCT00507949|"     The purpose of this trial is to study the effect of megestrol acetate in the gain of body     weight in patients with severe Chronic obstructive pulmonary disease in order to improve the     survival of the patients.   "
203240|NCT00507962|"     The goal of this clinical research study is find the highest safe dose of cisplatin that can     be given with liposomal doxorubicin in the treatment of advanced cancer involving the liver.      PRIMARY Objectives:      To determine the toxicity and safety of a monthly cytotoxic regimen combining intraarterial     hepatic (HAI) cisplatin with systemic intravenous liposomal doxorubicin in patients with     cancer metastatic to the liver.      SECONDARY Objectives:      To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial     cisplatin in combination with systemic liposomal doxorubicin.   "
203241|NCT00507975|"     There are no established evidences as to the effectiveness in smoking pregnant women of     nicotine patches in increasing birth weight, smoking abstinence during pregnancy and     concerning the safety their for the fetus/newborn. Moreover, recent studies have shown that     the metabolism of nicotine is speeded up in pregnant women suggesting that dose adaptation     may be necessary in this population. The main aim of this study is to assess the     effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth     weight and maternal smoking abstinence. The main secondary objective is the assessment of     safety of these treatments for the fetus/newborn and for the mother.   "
203242|NCT00507988|"     The primary purpose of the study is to assess whether a planning and problem-solving training     is more effective in improving work therapy performance in patients with schizophrenia than     traditional training programs addressing basic cognitive functions.   "
203243|NCT00508001|"     This is a multi-centre, phase II study to assess the efficacy and safety of ZD6474 in     patients with Child-Pugh class A, inoperable HCC. This study comprises 2 phases, the primary     treatment phase and the secondary treatment phase. The primary treatment phase is a     randomised, double-blind, parallel-group phase II study to assess the efficacy and safety of     ZD6474 300 mg plus best support care (BSC), ZD6474 100 mg plus BSC, and placebo plus BSC. The     secondary treatment phase is an open-label expanded access program of ZD6474. In the primary     treatment phase, patients will be randomised in a 1:1:1 ratio to receive ZD6474 300 mg plus     BSC, ZD6474 100 mg plus BSC, or placebo plus BSC, respectively. Randomisation will be     stratified on the basis of Cancer of the Liver Italian Programme (CLIP) tumour staging (CLIP     score 0-2 versus 3-4). The primary treatment will continue until objective disease     progression, according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria, or     until patients meet any other withdrawal or discontinuation criteria.The primary endpoint is     tumour stabilisation rate, and the secondary endpoints are objective response rate,     progression-free survival, and overall survival. The purpose of the secondary treatment phase     is to expand the access of ZD6474 so that every patient who is enrolled into this study can     have the chance to receive the active medicine.Once an individual patient has progressive     disease in the primary treatment phase, the blind will be broken for this patient. If this     patient is in the ZD6474 100 mg arm or placebo arm, the patient will be offered the secondary     treatment with ZD6474 300 mg per day. If this patient is randomised to the ZD6474 300 mg arm,     the study medication will be discontinued unless the patient wishes to remain the treatment,     and the patient is to be followed up for survival.   "
203244|NCT00508014|"     We will assess the impact of concurrent peer review vists on blood pressure, cholesterol and     diabetes control. Concurrent peer review (CPR) visits refer to special offic visits by     patients to a clinician (physician, nurse practitioner, or physician assistant) other than     than their primary care provider that are specifically designed to improve care for diabetes     and cardiovascular disease.   "
203245|NCT00508027|"     Recent clinical and experimental data indicate that statins have effects beyond cholesterol     lowering that may be beneficial in sickle cell disease by protecting the vascular     endothelium. Statins have been shown to attenuate endothelial dysfunction through their     anti-inflammatory, anti-oxidant and anti-thrombotic properties. This phase I/II     dose-escalating trial is designed to assess the safety and potential clinical efficacy of     oral simvastatin (Zocor)in adolescents and adults with sickle cell disease (SCD).   "
203246|NCT00508040|"     Birdshot Retine choroidopathy (BRC) is a sight threatening posterior uveitis. The long term     visual outcome has recently be studied showing a legal blindness to 14% at 5 years. Visual     acuity is threatened by macular edema (80%), macular atrophy, and choroidal     neovascularization.   "
203247|NCT00508053|"     The purpose of this study is to determine whether a technique using very small stitches when     closing a midline incision can reduce the risk for wound complications such as incisional     hernia, infection or dehiscence.   "
203248|NCT00508066|"     The purpose of this study is to evaluate the effects of continuous local anesthetic delivery     on the immediate post-op recovery of patients undergoing spinal fusion surgery for congenital     or idiopathic scoliosis.   "
203249|NCT00508079|"     Peripheral venous disease occurs when a vein becomes damaged or blocked. It can occur almost     anywhere in the body, but is most common in the arms and legs. This study will examine people     who participated in a previous venous disease study to evaluate changes in leg veins and     venous disease status over a period of 11 years.   "
203250|NCT00508092|"     The purpose of this study is to assess whether the use of local anesthetic to numb the nerves     that run deeper in the abdominal wall gives better post operative pain control than just     infiltrating local anesthetic to the wound edges.   "
203251|NCT00508105|"     This pilot study is being conducted to compare 2 methods of access to the shoulder for     arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.   "
203277|NCT00508443|"     The goal of this clinical research study is to find out if stereotactic spine radiotherapy is     safe and effective in the treatment of metastatic spine tumors. The feasibility of this type     of treatment will be studied as will any side effects related to the treatment. The precision     and accuracy of the CT-on-rails will also be studied.   "
203252|NCT00508118|"     Objective      The objective of this study is to discover whether an infusion of nicardipine is able to     reduce the time taken to achieve electrocerebral silence (ECS) during cardiopulmonary bypass     (CPB) for aortic surgery.      Hypothesis      By inhibiting cold-induced cerebral vasoconstriction, nicardipine will maintain cerebral     blood flow and allow more rapid cooling of the brain during CPB. This will manifest as a     reduction in the time taken to achieve ECS and also as a reduction in overall CPB time.   "
203253|NCT00508131|"     Iron deficiency and anemia in infants and young children impair neurodevelopment. Efficacious     interventions for reducing the prevalences of iron deficiency and anemia, under controlled     conditions, are available. However, little information is published about the effectiveness     of large-scale programs.      Objective. Assess the effectiveness on iron deficiency and anemia in young children of a     large-scale program that provides iron fortified milk at a subsidized price to low income     households. Design, Setting, and Sampling. A randomized effectiveness study in 12 milk     distribution clusters randomly selected from 542 clusters in 4 States in Mexico. Selected     clusters were randomly assigned to receive iron-fortified milk FM, N=7) or non-fortified milk     (NFM, N=5). Over 95% program beneficiaries with children 12-30 mo of age in the 12 clusters     (490 in FM and 275 in NFM) were enrolled in the FM and NFM interventions and participated in     a baseline survey. 635 children (405 in FM and 230 in NFM) and 584 children (371 in FM and     213 in NFM) completed the 6 and 12-mo follow-up surveys, respectively. Intervention: A daily     portion of FM contained 5.28 mg of iron, 48 mg of sodium ascorbate and other added     micronutrients. The FM and NFM were distributed to beneficiaries at a subsidized price in     Milk Distribution Centers in the 12 clusters.      Main outcome measures: Mild-to-moderate anemia (Hb: 90-109 g/L), mild anemia (Hb: 100-109     g/L), moderate anemia (Hb: 90-99 g/L),iron deficiency: Serum Ferritin (SF) <12 ug/L and     soluble transferring receptors (sTfR) >6 mg/L.Serum Zinc deficiency (< 65ug/dL), and stunting     (<2SD Height/Age.      Intervention effects at 6 and 12 moths were assessed using General Linear Mixed Models with     three repeated measures.   "
203254|NCT00508144|"     The goal of this clinical research study is to learn how effective the drug pemetrexed     (ALIMTA®) is in treating advanced NSCLC in patients with poor performance status (PS)     (inability to perform every day activities without difficulty).      Objectives:      Primary Objectives:        -  PS = 2 cohort: Response        -  PS = 3 cohort: Descriptive      Secondary Objectives:        -  Tolerability of single agent pemetrexed (Alimta®) in PS = 3 NSCLC patients        -  Improved symptoms (both cohorts)        -  Molecular Correlative studies (both cohorts)        -  Overall survival        -  Time to progression   "
203324|NCT00509054|"     Parastomal hernias are randomised to either a conventional stoma formed through the rectus     anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay     position.   "
203258|NCT00508196|"     Pacing from the right ventricle (as is current practice in patients implanted with permanent     pacemakers for bradycardia), has been associated with worse outcomes particularly in heart     failure patients. Recent clinical trials suggest that chronic right ventricular pacing (VP)     is associated with worsening heart failure, increased strokes and atrial fibrillation.     Hemodynamically, right VP results in delayed activation and contraction of the LV which can     give rise to functional mitral regurgitation, shortened diastolic filling time and thus     reduced coronary filling, as well as abnormal arterial pulsatile flow. The mechanisms for the     deleterious effects of right VP in heart failure patients have not been previously     investigated. Our aim of this study is therefore to investigate the hemodynamic effects of     right VP in stable heart failure patients in terms of exercise cardiac output (CO, an     important measure of myocardial function and prognosis), as well as endothelial function     which may be deranged as a result of abnormal arterial pulsatile flow.   "
203259|NCT00508209|"     The prognosis after retreating with high-dose melphalan with stem cell support after first     relapse after high-dose treatment is dependent on the time to first relapse. Bortezomib can     increase chemosensitivity of e.g. melphalan. The trial aims at determining the toxicity of     adding bortezomib to high-dose melphalan with stem cell support and evaluating whether the     time to a second relapse can be prolonged.   "
203260|NCT00508222|"     The study has been designed to test the hypothesis that in patients co-infected with HIV and     HCV who exhibit maximal virologic suppression on a double class antiretroviral (ARV) regimen,     including two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and a Non-nucleoside     Reverse Transcriptase Inhibitors (NNRTI) or a Protease Inhibitor (PI) (boosted or not with     ritonavir), simplification of highly active antiretroviral therapy (HAART) to Kaletra®     monotherapy will represent a viable strategy without any negative impact on the virologic     control of HIV infection.   "
203261|NCT00508235|"     The aim of this study is to determine if children with a higher disease severity have lower     quality friendships than children who are less severely affected and children who are     unaffected. Researchers will test the hypothesis that the quality of friendships is inversely     related to their disease severity.      Specific Aims:        1. To use the FQQ to determine if the quality of friendships in children with NF1 is lower          than the quality of friendships in unaffected children.        2. To use a disease severity scale and the FQQ to determine if children who are less          severely affected have higher friendship qualities than children who are more severely          affected.   "
203314|NCT00508924|"     This is a phase II multi-centre study in 140 patients undergoing elective PCI to obtain the     information on dose-response of argatroban in pharmacodynamic markers and to assess the     anticoagulation, safety and efficacy of argatroban in reference to unfractionated heparin, in     combination with dual antiplatelet therapy.   "
203262|NCT00508248|"     Unlike for ventricular arrhythmias, the role of n-3 PUFAs in atrial arrhythmias has not been     fully investigated. A recently published epidemiological study reported that in elderly     patients, consumption of fish was associated with a lower incidence of atrial fibrillation     over the 12 years of follow-up. This observation may be an indirect effect due to the overall     beneficial effort of fish consumption on reducing ischaemic heart disease, however this     association persisted after adjustment for confounding characteristics. Clinical data     regarding the direct impact of n-3 PUFAs on atrial arrhythmias such as atrial     fibrillation/flutter (AF) is lacking. However, as both INa and ICa-L are also in atrial     myocytes, similar anti-fibrillatory actions by n-3PUFAs would be expected in atrial     fibrillation and we would like to investigate this further. The primary aim of this study is     to investigate whether dietary supplements of n-3 PUFA concentrates (1g fish oil/day     comprising eicosapentaenoic acid, EPA 46% and docosahexaenoic, DHA 38%)) helps maintain sinus     rhythm after cardioversion to normal sinus rhythm in patients with persistent atrial     fibrillation.   "
203263|NCT00508261|"     The purpose of this study is to demonstrate, in 12-23 months old subjects, the     non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™,     compared to each vaccine administered individually and to licensed meningococcal vaccine     Meningitec™.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
203264|NCT00508274|"     Local study in China and Hong Kong to evaluate safety and efficacy in lapatinib +     capecitabine in women with HER positive advanced or metastatic breast cancer. Primary     objective is response rate.   "
203265|NCT00508287|"     The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of     single doses of BMS-686117   "
203266|NCT00508300|"     The purpose of this study is to determine whether a epidural analgesia versus patient     controlled analgesia reduces the medical recovery in patients undergoing elective     laparoscopic colon surgery.   "
203267|NCT00508313|"     The goal of this clinical research study is to evaluate whether thermal imaging (recording     body temperature) can be used to check the body's response to cancer therapy.      Primary Objective:        -  The primary objective of this study is to establish techniques and methodologies of          quantifying thermal signatures and their changes for cancer patients undergoing          chemoradiation therapy.      Secondary Objective:        -  The secondary objective is to evaluate correspondence between changes of thermal          signature of a normal organ, e.g. lung or esophagus, versus the toxicity of that organ          from chemoradiation therapy.   "
203268|NCT00508326|"     The goal of this clinical research study is find the highest tolerated dose of paclitaxel     that can be given directly into the liver of patients with advanced cancer involving the     liver. Researchers also want to collect descriptive information on any effects the drug may     have on tumor tissue.   "
203269|NCT00508339|"     Primary Objectives:        1. To classify the types of wound healing complications that occur after pre-operative          radiation therapy and limb sparing resection for the treatment of soft tissue sarcomas          of the extremity.        2. To evaluate the impact of each complication type on patient function and quality of life          using the Toronto Extremity Salvage Score (TESS).   "
203287|NCT00508573|"     The goal of this study is to create a registry of information about women who have or are at     risk for Lynch syndrome, in order to study gynecologic cancer risks.      Objectives:        1. To create a registry of women who have or are at risk for Lynch syndrome, and to monitor          and document their follow-up prospectively.        2. To have a repository of clinical data and tissue specimens that will serve as a secure          archive for future research.   "
203270|NCT00508352|"     Research has shown that treatment with conventional radiation techniques and chemotherapy     following mastectomy or breast conserving surgery has resulted in better rates of     locoregional control and overall survival in stage IIB-III breast cancer. The current     feasibility trial using the most recent advance in radiation therapy, namely helical     tomotherapy intensity modulated radiation therapy (HT-IMRT), hopes to improve on the results     of conventional radiation by decreasing the amount of radiation-induced toxicity in patients     with stage IIb-III breast cancer.   "
203271|NCT00508365|"     This is a multi-center, double-blind, randomized, placebo-controlled, 2-session crossover     study to evaluate the incidence of orthostatic hypotension in elderly hypertensive subjects     following co-administration of carvedilol CR and lisinopril.   "
203272|NCT00508378|"     Primary Objectives:        1. To assess the preferences of women with ovarian cancer, their clinical caregivers,          familial caregivers, and a control group for toxicities associated with chemotherapy.             -  To compare preferences of women with ovarian cancer to preferences of their               clinical caregivers.             -  To compare preferences of women with ovarian cancer to preferences of their               familial caregivers.             -  To compare preferences of women with ovarian cancer to preferences of a women in               the control group.        2. To prospectively collect quality of life data from women with ovarian cancer.        3. To prospectively collect symptom assessment data from women with ovarian cancer.   "
203273|NCT00508391|"     The purpose of this study is to demonstrate that the safety and efficacy of the Lumax HF-T     with optimized interventricular delay biventricular pacing (OPT) is non-inferior to the Lumax     HF-T with simultaneous biventricular pacing (SIM) in patients with heart failure requiring     cardiac resynchronization therapy.   "
203274|NCT00508404|"     To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective     response rate and other measures of efficacy for patients treated with panitumumab in     combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin     (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).   "
203275|NCT00508417|"     This study, conducted by the Malaria Research and Training Center at the Faculty of Medicine     in Bamako and the NIAID will measure the frequency of occurrence of malaria in infants in     Bancoumana, Mali. Information from the study will help in planning trials of malaria     vaccines.      Healthy children from 6 weeks to 6 months of age who live in the Bancoumana health area may     be eligible for this study. Candidates are screened with a physical examination and blood     tests.      Participating children are visited at home for a total of about 17 visits to see if they are     well. They come to the clinic every month during the 7-month study for a clinical evaluation,     including a blood sample obtained by finger prick to test for malaria. Some of the blood     collected may be stored and used for research. Children who become sick with malaria are     treated for the disease.   "
203276|NCT00508430|"     To demonstrate the superiority of ASP8825 over placebo and dose response in patients with     painful diabetic polyneuropathy.   "
203278|NCT00508456|"     Objectives:        1. To determine the safety, tolerability and efficacy of dietary methionine restriction for          7 days alternating with Temodar® (Temozolomide) given once a day for seven days and this          repeated for up to one year in the treatment of patients with recurrent and/or          progressive glioblastoma.        2. To determine the short- and long-term toxicity of dietary methionine restriction          combined with Temodar® in glioblastoma patients.        3. To measure and correlate patients' tumor responses and progression-free survival with:          serum methionine and peripheral blood lymphocyte methylation levels. In any patient          undergoing surgery, to measure tumor alkylguanyl transferase (AGT) and methionine levels          and compare to control specimens.   "
203279|NCT00508469|"     The purpose of the study is to compare adherence in patients on a fixed combination of     travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004%     and timolol 0.5% using the Travalert® device.   "
203280|NCT00508482|"     The purpose of this study is to re-evaluate the therapeutic superiority and safety of     acupuncture treatment using high quality and large sampled clinical research. The     investigators want to provide a preferred treatment protocol, which is effective, safe, and     easy to use in clinical practice. This research also clarifies that the insertion depth is a     key factor in the therapeutic effect of acupuncture. The results of the study will help     promote the development of the standardization of acupuncture.   "
203281|NCT00508495|"     The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability     of two different paracetamol-containing solutions in postoperative total hip replacement.     They will be compared to placebo (a dummy treatment which contains no active ingredient).   "
203282|NCT00508508|"     Heart failure (HF) patients living in low-income or isolated areas may have limited access to     necessary clinic services and more difficulty in self-managing their illness. This study will     evaluate a program that combines group health care visits and a peer-to-peer telephone buddy     system at improving health outcomes among low-income and racial minority HF patients.   "
203283|NCT00508521|"     Many stroke survivors exhibit persistent upper limb motor deficits and a non-functional upper     limb. There is some promising information that suggests motor learning (ML) in conjunction     with functional electrical stimulation (FES; surface FES; nothing implanted; use of a     commercially available system) of wrist/finger muscles can significantly enhance the     functional level of the upper limb. There have been promising studies showing that some     subjects in the chronic phase (greater than 6 months after stroke) responded favorably to     combination FES and ML (FES ML). In our pilot studies, FES ML for those in the chronic phase     (>12 months) produced statistically significant functional recovery. FES was applied using a     commercially available, two-channel FES system, with electrodes applied to the surface of the     skin (non-invasive). But if upper limb dysfunction is not immediately treated, that is within     the sub-acute phase (less than 6 months) following stroke, the following problems can     develop: contractures and other soft tissue changes; chronic pain; and ingrained, abnormal,     non-functional movement patterns. The more long-standing these symptoms are, the more     resistant to treatment they become. Therefore, it is important to provide promising     interventions prior to the onset of chronic symptoms and dysfunction. Those in the sub-acute     phase after stroke should be provided with FES ML, in order to more completely restore     function for a greater number of stroke survivors.      Specific Aims and Hypotheses The goal of this pilot study is to test the feasibility of the     proposed treatment in the sub acute phase following stroke.      HYPOTHESIS. FES ML for 3hrs/day, five days/week, for 12 weeks will be feasible to implement     in the sub-acute phase following stroke (2 -24 weeks).      Study Design      a. Specific Procedures This is a pilot study to test the feasibility of using FES ML for     upper extremity rehabilitation in a sub-acute stroke population. It is a randomized,     controlled, single-blind design. Subjects will be 2 - 24 weeks after a single stroke. The     control group will receive standard care for upper limb rehabilitation consisting of passive     and active exercise, stretching, bracing, and use of adaptive devices. The experimental group     will receive the experimental intervention in addition to their standard care.      CONTROL GROUP INTERVENTION. The control group will receive the standard medical care     prescribed by the primary physician and covered by the subject's health care policy. Standard     care will include: soft tissue mobilization; assisted motion exercise; active motion     exercise; resistive exercise; task practice; use of assistive devices; and modality     applications conventionally prescribed.      FES ML INTERVENTION. The research treatment duration will be 3hrs/day, five days per week.     The subjects will be present for a fourth hour each day, which will be used for breaks and     rest periods that will be interspersed throughout the intervention time. The treatment     duration is derived from prior work. We will stimulate muscles in a number of configurations     including: wrist extension and finger extension; wrist extension and finger flexion; and     wrist extension, finger flexion, and thumb abduction and opposition. Motor learning will     include the performance of functional task components and full task practice during the use     of FES. FES will be triggered by the patient, the treating therapist, or it will be     automatically sequenced by the device according to alternate channel activations, with     timings pre-set by the treating therapist.      MEASURES. Data will be collected at weeks 1, 6, 12 (end of treatment), and 6 months after the     end of treatment.      Population The subjects will be sub-acute stroke survivors (2-24 weeks after stroke).   "
203284|NCT00508534|"     This study will examine the effects of altering gastric pH in healthy volunteers on the     pharmacokinetics of SB-751689 with or without food.   "
203285|NCT00508547|"     The purpose of this study is to further evaluate the safety of infliximab and ustekinumab in     patients with plaque psoriasis, and other all forms of psoriasis (such as plaque psoriasis     and psoriatic arthritis occurring together). The registry study will track the behavior of     the disease in response to other therapies, such as other biologic drugs. The registry will     also evaluate clinical outcomes; disease characteristics, including physician reported     assessment of psoriatic arthritis (PsA); quality of life, and potential risks for patients     who may receive standard therapies for psoriasis.   "
203286|NCT00508560|"     This study examines the use of contingent incentives to increase attendance at smoking     cessation treatment sessions by smokers with schizophrenia and other psychoses who want to     quit smoking. We hypothesize that participants randomized to receive contingent rewards for     group attendance will attend more treatment sessions than those in the control group.   "
203325|NCT00509067|"     This study will evaluate the effectiveness of galantamine and CDP-choline in improving     symptoms associated with schizophrenia.   "
203288|NCT00508586|"     Formation of new blood vessels (angiogenesis) is important for tumor growth in metastatic     breast cancer. It is known that tumors make a protein called vascular endothelial growth     factor (VEGF) and there are higher levels of VEGF in the tumors and blood of many women with     metastatic breast cancer. VEGF stimulates the formation of blood vessels that supply the     tumor with nutrients and oxygen. PTC299 is an oral drug that has been shown to decrease     production of VEGF in animal models of human cancer. In these animal models, oral PTC299     administration decreases VEGF levels in the tumor and in the bloodstream, decreases blood     vessel numbers in the tumor, and significantly slows or halts tumor growth. Safety studies in     research animals indicate good tolerability at doses and drug levels that are higher than     those planned for the clinical studies. Results from Phase 1a studies in healthy volunteers     indicate that PTC299 achieves levels of PTC299 in the bloodstream that are known to be active     in animal models of human cancer. This Phase 1b study is designed to test the hypothesis that     PTC299 will be tolerable and will show evidence of VEGF reduction and antitumor activity when     administered orally in combination with anastrozole (Arimidex®), letrozole (Femara®), or     exemestane (Aromasin®) to women with metastatic breast cancer.   "
203289|NCT00508599|"     The hypothesis of this study is that bed rest in diabetic patients will result in a     deterioration of metabolic control (primarily glucose).      Specific aims:        1. To determine the change in metabolic control in type 2 diabetic individuals when three          days of bed rest is compared to three days of activity;        2. To determine the rate of progression of the deterioration in metabolic control and the          magnitude of the decrease;        3. To assess whether the anticipated deterioration of metabolic control has effects on          several parameters of glucose metabolism, including hyperglycemia and hypoglycemia;        4. To determine the effects of bed rest on surrogate markers of atherosclerosis, such as          plasminogen activator inhibitor 1 (PAI1), C-reactive protein (CRP), and homocysteine.        5. To compare the effects of 48 hours of bed rest on orthostatic responses in type 2          diabetic patients, and healthy non-diabetics.        6. To make recommendations to the diabetic community to prevent metabolic deterioration          during a 3 day hospitalization.   "
203290|NCT00508612|"     High blood pressure can often be caused by stress or anxiety. This study will evaluate a     school-based stress and anger management program that aims to lower blood pressure and anger     levels among high school students.   "
203315|NCT00508937|"     The overall objective of the Dietary Protein and Insulin Sensitivity Study is to test the     hypothesis that increased protein in a diet with reduced carbohydrate (35% energy) can     ameliorate insulin resistance in the absence of weight loss, and that this effect is     independent of saturated fat content. Moreover, we will test whether such diets result in     beneficial changes in total LDL cholesterol, small, dense LDL, and HDL cholesterol that are     also independent of saturated fat intake.   "
203291|NCT00508625|"     This is a phase 2 multicenter, open label, randomized study of AMG 951 (rhApo2L/TRAIL) in     subjects with previously untreated stage IIIb/IV NSCLC treated with chemotherapy with or     without bevacizumab.      Subjects will be assigned to a set of treatment groups depending on their eligibility to     receive bevacizumab. Subjects with squamous NSCLC and/or CNS metastases will not be eligible     to receive bevacizumab and will be assigned to either cohort A or B (provided all other     eligibility criteria are met). Subjects who are eligible to receive bevacizumab will be     assigned to cohort C, D or E. Cohorts are defined as follows:      Subjects with squamous NSCLC or CNS mets:      Cohort A: Chemotherapy alone Cohort B: Chemotherapy plus 8 mg/kg AMG 951 for 5 days      Subjects without squamous NSCLC and without CNS mets:      Cohort C: Chemotherapy and bevacizumab Cohort D: Chemotherapy, bevacizumab plus 8 mg/kg AMG     951 for 5 days Cohort E: Chemotherapy, bevacizumab plus up to 20 mg/kg AMG 951 for 2 days     Approximately forty subjects will be recruited to each cohort.   "
203292|NCT00508638|"     People with heart failure (HF) symptoms who are seen in the emergency department (ED) are     often admitted to the hospital even though it may not be necessary. This study will gather     information from HF patients seen in the ED to develop a decision-making tool that will help     doctors predict the risk of HF-related death or serious complications. Improving the ability     of ED doctors to effectively and safely manage low-risk HF patients should lead to fewer     unnecessary hospitalizations.   "
203293|NCT00508651|"     The primary objective of this study is to describe the safety and tolerability of 3 doses of     MEDI-560 at 10^5 TCID50 when administered to children 6 to < 12 months of age who are HPIV3     (human parainfluenza virus type 3) seronegative at baseline and to infants 1 to < 3 months of     age regardless of baseline serostatus.   "
203294|NCT00508664|"     The DeLOS II trial is a multicenter randomised phase II trial investigating a     TP/5-Fluorouracil (TPF)-chemotherapy with or without cetuximab for Patients with only by     laryngectomy operable carcinoma of the larynx/hypopharynx. Patients were divided in responder     or non-responder after 4 weeks. Since August 2009 Responder receive TP with or without     Cetuximab + radiation. (Until february 2009 Responder received TPF with or without Cetuximab     + radiation.) Planned accrual is 85 patients per treatment arm. The primary study endpoint is     a confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2     years after randomisation.   "
203295|NCT00508677|"     This prospective pilot trial will evaluate the efficacy, safety, tolerability and     pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.   "
203296|NCT00508690|"     The purpose of this study is to determine optimal prophylactic antibiotics administration     method in elective laparoscopic colorectal surgery.   "
203297|NCT00508703|"     The goal of this clinical research study is to use CT scans to find any changes in position     of the vagina and pelvic lymph node areas during the course of IMRT radiation therapy.     Treatment can then be adjusted in order to spare as much normal tissue as possible during     radiation therapy. Another goal is to study the side effects of IMRT radiation therapy.   "
203308|NCT00508846|"     Among women with HNPCC, this study will assess:        1. Knowledge of screening recommendations for endometrial and ovarian cancers.        2. Perceived risk and cancer worries regarding endometrial, ovarian and colorectal cancers.        3. Adherence to screening recommendations for endometrial, ovarian and colon cancers.        4. Perceived benefits,supports and barriers to endometrial and ovarian cancer screening.        5. Patterns of communication about endometrial and ovarian cancer risk within families with          HNPCC and with health care providers.        6. Patient preferences for potential cancer screening and cancer prevention strategies          related to HNPCC-associated cancers.   "
203298|NCT00508716|"     The primary aim of this project is to test the efficacy of an inpatient congestive heart     failure (CHF) educational intervention compared with usual care among inpatients at Griffin     Hospital, who are largely drawn from the population of the Naugatuck Valley in Connecticut.      The educational intervention will utilize:        -  written educational materials suitable for patients with low health literacy -          alternatives to written materials (e.g., video- and audiotapes) that may more          effectively communicate health information to elderly patients and those with low health          literacy        -  a one-on-one educational session with a nurse patient educator. The educational session          will use as its framework guidelines provided by the America Medical Association (AMA)          to improve communication between healthcare providers and low health literacy patients.          The investigators hypothesize that CHF patients who receive this educational          intervention will have fewer hospital readmissions or deaths than the usual care group.          The investigators further hypothesize that patients with low health literacy will derive          more benefit from the intervention than patients with higher literacy.      The secondary aims of the project are to:        -  assess whether patients in the education and usual care groups differ on post-discharge          CHF knowledge and on satisfaction with hospital care. Compared with usual care, the          investigators hypothesize that CHF patients who receive the educational intervention          will have better knowledge of CHF and will be more satisfied with the care they received          in the hospital.      The potential impact of the proposed project may be to increase disease knowledge and health     literacy, and improve adherence to CHF treatments. This, in turn, may contribute to improved     medical outcomes and reduced hospital readmissions for CHF patients. In addition, if this     preliminary study provides evidence of a promising educational intervention suitable for     patients with low health literacy, th investigators will endeavor to test the intervention in     ethnically diverse populations throughout Connecticut.   "
203299|NCT00508729|"     With multicenter randomized control clinical evaluation investigations, the effect of     traditional Chinese medicine on gastrointestinal function recovery and nutrition support in     early stage of severe acute pancreatitis (SAP) was evaluated, and the therapeutic effects,     safety and indications assured. Drawing in latest research fruits at home and abroad, a     clinical practical guideline would be formed, to be popularized all over China.   "
203300|NCT00508742|"     This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine     (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.   "
203301|NCT00508755|"     Conventional therapies do not restore normal gait for many stroke survivors. The long-term     goal of this work is to restore volitional lower limb motor control and gait following     stroke. In our prior work, we demonstrated that it was feasible to provide a clinically     operated, combined treatment of body weight supported treadmill training alone (BWSTT) +     functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM).      Specific Aims and Hypothesis The purpose or Specific Aim of the study is to test the     feasibility and gait training potential of combining the Lokomat and FNS-IM for stroke     survivors. Given the feasibility of our clinically operated combination of BWSTT + FNS-IM, we     propose to test the feasibility of the combination of Lokomat + FNS-IM.      Hypothesis I. It is feasible to utilize a clinically operated combination of Lokomat +     functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM).      Treatment Procedures. The subjects will be treated for three months, four sessions/week (for     a total of 48 treatment visits). A given session will be 1 hrs, with the time divided into     thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) hr     Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the     subject is capable of volitionally executing a given movement or gait component. Population.     The subjects will be chronic stroke survivors (>6 months after the stroke).   "
203302|NCT00508768|"     The purpose of this study is to assess the pharmacokinetics of two oral dosing regimens of     SCIO-469, with and without methotrexate, in patients with active rheumatoid arthritis.   "
203303|NCT00508781|"     We use multiphoton laser scanning microscopy to observe cutaneous anatomy and pathology. The     study aims to compare surgical specimen by conventional pathology slice with the image by     non-invasive multiphoton laser scanning microscopy.   "
203304|NCT00508794|"     In this study researchers will examine the initial efficacy of implementing a yoga program     for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast     cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG),     or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and     ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule.     The sessions will be coordinated with the treatment schedule and conducted adjacent to the     treatment facility. Measures will be obtained prior to randomization, a brief assessment     during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3     and 6 months after the last radiation session. With the inclusion of two control groups in     this randomized trial researchers will attempt to validate the benefits of yoga as an     adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for     specific components of the yoga program and also examine some of the mechanisms that are     necessary for the program to be effective.      Our specific aims in the proposed study are to:        -  Conduct an initial evaluation of whether participation in the yoga program improves          patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with          self-report measures and the use of actigraphy for a more objective measure of sleep          quality.        -  Secondary end points will include examining QOL, mental health and objective          physiological outcomes (blood samples for immune measures, saliva samples for cortisol          levels, and heart rate variability).        -  Exploratory analyses will examine some plausible mediators of the yoga program including          cognitive processing, spirituality, and finding meaning in the cancer experience.   "
203305|NCT00508807|"     Primary:        -  To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase          II dose of RTA 402 capsules in patients with advanced solid tumors or lymphoid          malignancies who have failed standard-of-care curative or survival-prolonging therapy,          or for whom no such therapies exist.        -  To characterize the pharmacokinetics of RTA 402 capsules administered orally for 21 days          in this patient population.      Secondary:        -  To document any preliminary antitumor activity of RTA 402 in this patient population.        -  To determine the in vivo molecular and biological effects of RTA 402 by measuring          changes in markers of differentiation, apoptosis, and anti-inflammatory effects in WBCs,          blood plasma, and, in consenting patients, tumor biopsies.        -  To correlate the biological activity of RTA 402 with drug concentration in plasma and          blood cellular elements        -  To evaluate the series of inflammation related symptoms over the course of the study,          and to determine the correlation of symptom intensity with plasma cytokines.   "
203306|NCT00508820|"     This protocol will provide open label romiplostim to adult thrombocytopenic subjects.     Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment     will be based on platelet counts, and will be allowed throughout the duration of the study.     Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP     therapies may occur at any time when platelet counts are > 50,000.   "
203307|NCT00508833|"     This study was done to evaluate the effect of various adjuvants in combination with HBsAg as     a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in     healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the     various adjuvanted vaccines.   "
203309|NCT00508859|"     This study examined the benefit of continued treatment with an antidepressant medication,     sertraline, in adolescents with depression who improved on sertraline acutely. We hypothesize     that adolescents who remained on sertraline long term were less likely to have a recurrence     of depression compared to those on placebo.   "
203310|NCT00508872|"     Objective:        -  To evaluate the efficacy of the use of the combination of oxaliplatin, 5-fluorouracil,          leucovorin and bevacizumab (FOLFOX-B) in patients with unresectable colorectal liver          metastases, with the objective to downstage hepatic disease and enable complete          resection of residual disease.      Primary Objective:        -  To evaluate the resection rate in patients with initially unresectable hepatic          colorectal metastases downstaged with FOLFOX-B. Complete resection of all liver lesions          is the goal.      Secondary Objectives:        -  To evaluate the probability of complete response, partial response or stable disease.        -  To evaluate the proportion of patients who are resected, and the proportion of patients          achieving an R0 resection (among those receiving surgery).        -  To correlate survival with downstaging and resection based on metastatic colorectal          prognostic score.        -  To evaluate the disease-free survival and overall survival.        -  To evaluate the positron emission tomography response rate.        -  To explore correlations of clinical response with telomerase and hTERT expression.   "
203311|NCT00508885|"     Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are     insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of     vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the     use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma     phosphorus levels in peritoneal dialysis patients versus placebo.   "
203312|NCT00508898|"     Glomerulonephritis and renal failure represent one of the most life-threatening     manifestations of systemic lupus erythematosus (SLE). Although immunosuppressive therapy is     often effective for the treatment of acute lupus nephritis, a significant proportion of     patients show persistent proteinuria after resolution of the acute nephritic process, and     develop progressive renal failure. There is preliminary evidence that calcitriol and other     vitamin D analogs can reduce proteinuria in patients with chronic kidney diseases. The     investigators plan to conduct a randomized control study to evaluate the safety and efficacy     of calcitriol in the treatment of SLE patients with persistent proteinuria. Sixty patients     with clinically quiescent SLE and persistent proteinuria despite conventional therapy will be     recruited. They will be treated with calcitriol for 48 weeks. Proteinuria, renal function,     lupus disease activity, serum and urinary inflammatory markers will be monitored. This study     will explore the potential anti-proteinuric and immunomodulating effects of calcitriol in the     treatment of SLE, which is a common and life threatening disease in young adults.   "
203313|NCT00508911|"     This study will be conducted in healthy female volunteers to investigate the effect of     GW876008 on the pharmacokinetics of oral contraceptive pills.   "
203318|NCT00508976|"     The purpose of this study is to determine if pre-incisional lidocaine injection, instilled     liquid bupivacaine, intra-abdominal aerosolized bupivacaine, or post-operative bupivacaine     injection is superior in post-operative pain control in laparoscopic bariatric surgical     patients.   "
203319|NCT00508989|"     This study will determine whether niacin can improve blood flow in people with sickle cell     disease, in which abnormal red blood cells interfere with blood flow to cause the disease     symptoms. Niacin, a drug that has been used to increase HDL (good cholesterol) levels,     improves blood flow in people without sickle cell disease. This study will see if it can do     the same in people with the disease.      Patients with sickle cell disease between 18 and 65 years of age may be eligible for this     study.      Candidates are screened with a medical history, physical examination, blood tests,     echocardiogram and 6-minute walk test of exercise capacity.      Participants have the following baseline blood flow studies:        -  Flow-mediated dilation (FMD): An ultrasound picture of the artery in the forearm is          obtained. A blood pressure cuff is then placed on the upper arm and inflated for 5          minutes. After the pressure cuff is released, the ultrasound is repeated.        -  Peripheral artery tonometry (PAT): A sensor is placed on the subject s finger. The          sensor puts pressure on the finger and measures blood flow.        -  Standard forearm blood flow test: Small tubes are placed in the artery of the forearm at          the inside of the elbow. Saline is infused into one tube. Pressure cuffs are applied to          the wrist and upper arm. A strain gauge (rubber band device) is placed around the          forearm. When the cuffs are inflated, blood flows into the arm, stretching the strain          gauge, and the flow measurement is recorded. Blood samples are collected from the tube          in the artery to measure blood counts, proteins and other chemicals. At various times,          small doses of the following drugs are administered through the tube in the vein:             -  Sodium nitroprusside causes blood vessels to dilate and increases blood flow to the               heart.             -  Acetylcholine causes blood vessels to dilate and slows heart rate.             -  LNMMA decreases blood flow by blocking the production of nitric oxide.      Blood flow is measured after each dose of the different drugs. There are rest periods between     injections of the different drugs. Pictures of the forearm are taken during the studies using     an infrared camera and computer.      -Drug Treatment. Participants are assigned to take three 4-week courses of niacin or placebo.     They return to the Clinical Center at the following intervals from the time they start the     test drug for followup:        -  Weeks 2, 6 and 10: Brief medical history, review of medication side effects and blood          tests.        -  Weeks 4 and 8: Physical examination, brief medical history, review of medication side          effects and blood tests, repeat FMD and PAT blood flow studies and 6-minute walk test.        -  Week 12: Same as weeks 4 and 8 plus standard blood flow studies and echocardiogram....   "
203320|NCT00509002|"     The goal of this clinical research study is to learn if ZD1839 (Iressa®, gefitinib can help     to shrink or slow the growth of advanced, recurrent, or metastatic salivary gland cancer. The     safety of this drug will also be studied.   "
203321|NCT00509015|"     In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a     tool for malaria control in 'exceptional conditions when conventional control strategies have     failed'. Subsequently, MDA has received little attention until the introduction of     artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria     transmission by clearing the population of sexual stage parasites, gametocytes, prior to the     transmission season. Gametocytes are essential for propagation of the disease and elimination     of gametocytes will result in a reduction in malaria transmission. As a consequence, a     successful MDA will reduce the burden of disease in a population and is expected to have     little influence on the development of protective immunity in areas of low transmission     intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That     study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of     artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible     reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on     malaria transmission, the incomplete coverage, the relatively high transmission intensity in     the area and the migration of individuals between villages. Here, we propose to conduct an     MDA study in an area of very low malaria transmission intensity in Tanzania. We use the     highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..   "
203322|NCT00509028|"     This study will include the patients who are Japanese children with bronchial asthma aged 5     years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at     about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of     100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks Phase III study (Study     D5254C00769, NCT00504062) as compared with conventional therapy in Japanese children with     bronchial asthma in need of inhaled glucocorticosteroid treatment.   "
203326|NCT00509080|"     The purpose of this study is to determine if the use of BNP/NT-proBNP levels in the detection     of early left ventricular dysfunction and damage may improve the timing of cardiac surgery     and therefore the long-term management of asymptomatic patients with severe mitral     regurgitation.   "
203327|NCT00502645|"     This is a single-center, open, non-controlled clinical investigation in 10 patients at the     Medical University Graz including a treatment visit (V1)and a follow up visit(V2). In the     treatment visit (V1) after admittance to the ICU arterial blood glucose values will be     monitored and either the software-algorithm eMPC will be used to adjust the infusion rate of     intravenously administered human soluble insulin to normalise arterial blood glucose. The     purpose of the present study is to investigate the performance of the already developed and     tested algorithm in combination with a newly developed bed-side, touch screen user interface     (CS-1 decision support system) in patients at the medical ICU for a period of 72 hours.     Follow up information(V2) will be acquired at hospital discharge or at the latest one week     after visit 1.   "
203338|NCT00502788|"     Hepatitis C is one of the most common causes of long-term liver disease in the United States.     Ribavirin and peginterferon alfa-2a are two medications that are used to treat hepatitis C     infection. The purpose of this study is to evaluate the safety of these two medications in     adults with hepatitis C and thalassemia, a type of blood disorder.   "
203339|NCT00502801|"     The purpose of this study is to evaluate the effectiveness and safety of doripenem     monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.   "
203340|NCT00502814|"     The goal of this clinical research study is to characterize the 3-dimensional form and     mechanical properties of the breast. Researchers want to do this in order to develop new high     technology tools for improving the diagnosis and treatment of breast cancer in women.   "
203341|NCT00502827|"     The goal of this research study is to look at treatments that may help individuals who have     HIV/AIDS to stop smoking.   "
203328|NCT00502658|"     Excessive body weight is becoming a concern around the world, for example over half of the     American adult population is overweight or obese. The purpose of this study is to determine     whether dietary supplements and shakes containing a combination of nutrients/ingredients     individually shown in research studies to reduce hunger, enhance metabolism, reduce the     body's ability to 'store' fat, and enhance energy, promote healthy body weight and     composition over 12 weeks. A further study objective is to determine whether the inclusion of     a personal, easy to use, energy tracking device for the measurement of daily energy intake     and expenditure also helps with the promotion of healthy body weight and body composition.      In this prospective, blinded study 120 volunteers who meet the entrance criteria including a     BMI 25-35 kg/m2 and sign the informed consent form to participate in a 12 week long study     will be recruited. All subjects will consume a multi-vitamin, mineral and fish oil     supplement. Subjects will be randomly assigned to a control or experimental group and     stratified by BMI 25-30 and >30-35 kg/m2, age, and gender with an equal number of subjects in     each strata across groups. A subset of subjects will also wear a personal energy tracking     device. Subjects will be instructed how to incorporate the shakes and supplements into their     current diet and encouraged to incorporate fruits, vegetables, whole grains, and other     healthy foods into their current meals and to exercise at least 30 minutes five days per     week.   "
203329|NCT00502671|"     This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant     treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as     intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week     without treatment). The anticipated time on study treatment is 3-12 months, and the target     sample size is 500+ individuals.   "
203330|NCT00502684|"     Surgery for breast cancer has a major role in enhancing long term survival and cure, but     several physiological aspects associated with surgery are implicated as enhancing tumor     spread and formation of distant metastases. These include: an increase in pro-angiogenic     factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and     direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these     pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely     by administration of beta-adrenergic blockers and COX2 inhibitors around the time of surgery.      Studies have shown that surgery increases levels of catecholamines and prostaglandins, which     in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance     vascularization of micro metastases.      Opiates given for pain relief during and after surgery have been reported to enhance tumor     cell division and cause immune suppression.      The immune system is significantly suppressed during surgery. This suppression has been shown     to affect the systemic resistance to infection as well as neoplastic metastatic processes.      Several studies have shown that increased levels of catecholamines and prostaglandins add to     the immune suppression.      Studies in rats found that peri-operative administration of the beta beta-blocker propranolol     together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell     activity as well as the risk for distant metastases.      A recent retrospective clinical study found that among breast cancer patients treated with a     combination of regional anesthesia and a COX inhibitor the recurrence rated were     significantly less than among patients undergoing surgery without these two interventions.      The purpose of the proposed prospective trial is to examine if peri-operative administration     of the combination of a beta-blocker together with a COX2 inhibitor will prevent suppression     of cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates.      In the proposed study breast cancer patients will be treated with a combination of a     beta-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control     group of healthy women will serve as untreated controls). The variables which will be     examined are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress     hormones and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2     cytokines as a result of in vitro stimulation.      In addition to these immediate parameters, long term follow up will be conducted in order to     determine the effect of the intervention on long term cancer recurrence over five years.      Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with     regard to the known risk factors for recurrence such as tumor grade, lymph node involvement     etc. Sample size for immunological parameters will be 40 patients in each group and 20     healthy women. Sample size for estimates of cancer recurrence at five years of follow up wiil     be 460 women (230 in each group). This sample size provides a power of 80% to detect a 50%     reduction in cancer recurrence at an α of 0.05.   "
203331|NCT00502697|"     Women with a history of a prior preterm birth (PTB) have a high probability of a recurrent     preterm birth. Some risk factors and health behaviors that contribute to PTB may be amenable     to intervention. Home visitation is a promising method to deliver evidence based     interventions. We evaluated a system of care designed to reduce preterm births and hospital     length of stay in a sample of pregnant women with a history of a PTB. All participants (N =     211) received standard prenatal care. Intervention participants (N = 109) also received home     visits by certified nurse-midwives guided by protocols for specific risk factors (e.g.,     depressive symptoms, abuse, smoking). Data was collected via multiple methods and sources     including intervention fidelity assessments. Average age was 27.6 years. Racial breakdown     mirrored local demographics. Most women had a partner, a high school education, and Medicaid.     Enhanced prenatal care by nurse-midwife home visits may limit some risk factors and shorten     intrapartum length of stay for women with a prior PTB. This study contributes to knowledge     about evidence-based home visit interventions directed at risk factors associated with PTB.   "
203332|NCT00502710|"     This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a     DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be     randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o.     Patients receiving metformin before the study will continue on the same dose of metformin.     The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
203333|NCT00502723|"     National multicentric prospective open study, comparing two current surgical methods:     laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy     for a localised prostate cancer.   "
203334|NCT00502736|"     This single arm study will assess the efficacy and safety of loading doses of intravenous     Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to     severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2     and 3. The anticipated time on study treatment is 3 months, and the target sample size is     <100 individuals.   "
203335|NCT00502749|"     This pilot study will examine the safety, feasibility, and effect on quality of life of     moderate physical activity on adolescent and young adult patients who are admitted to the     hospital periodically for routine chemotherapy. Patients will be asked to participate in     daily physical exercise during hospital admissions over a three-month period. Exercise     sessions will be monitored and guided by M.D. Anderson physical therapists, a personal     trainer, and Dr. Michael Rytting, pediatric oncologist. The personal trainer will meet with     each participant for reinforcement and to provide an opportunity for exercise between     hospitalizations. If results are positive, the study will be extended to a larger cohort of     patients.   "
203336|NCT00502762|"     Although the efficacy of topotecan as second-line chemotherapy for SCLC has been consistently     demonstrated in phase II/III clinical trials, the choice of irinotecan as first-line therapy     prevented use of the evidence-based option.      This pilot study will be conducted to determine the activity and safety of topotecan in SCLC     patients refractory to first-line therapy with irinotecan and platinum.   "
203342|NCT00502840|"     This single arm study will evaluate the efficacy and safety of repeated courses of MabThera     in patients with active rheumatoid arthritis who have participated in ML19070, and have     completed the week 24 visit. Eligible patients (DAS28 >2.6 after week 24), will receive 2     infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to     3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2     years, and the target sample size is 100-500 individuals.   "
203343|NCT00502853|"     This single arm study will measure the effect of MabThera in combination with methotrexate on     the progression of synovitis, the extent of bone marrow edema, and the number of erosions in     the wrist and hand of patients with rheumatoid arthritis, using a new MRI technique. Patients     will receive MabThera 1000mg i.v. on days 1 and 15, in combination with a stable dosage of     10-25mg/week methotrexate throughout the duration of the study. Further courses of MabThera     will be provided to eligible patients. MRI will be performed 1-2 weeks before treatment     initiation, and repeated 1 and 6 months after the first MabThera infusion. The anticipated     time on study treatment is 1-2 years, and the target sample size is <100 individuals.   "
203344|NCT00502866|"     Some experts recommend that all breastfed babies receive supplemental vitamin D. The purpose     of this study is to determine the rate of vitamin D use in breastfed babies, the     recommendations of pediatricians regarding vitamin D, and the impact on these recommendations     on parental choice of vitamin D. In addition, in preparation for a large study to see how     many breastfed children who don't receive supplemental vitamin D have rickets, in this study     we will determine if a simple blood test, an alkaline phosphatase level, could be used to     screen for rickets. Parents of children 6-23 months old are eligible to complete feeding     surveys and children 6-15 months old who were breastfed for at least the first six months of     life and didn't routinely receive vitamin D are eligible for alkaline phosphatase levels. We     postulate that most breastfed babies don't receive supplemental vitamin D, and that alkaline     phosphatase levels will only be abnormal in a few babies who will have evidence on x-ray of     rickets.   "
203345|NCT00502879|"     The primary purpose of this study is to assess the pharmacokinetics of etanercept in healthy     Chinese male subjects. Safety and tolerability data will also be obtained.   "
203346|NCT00502892|"     Primary Objectives:        -  To determine the maximum tolerated dose (MTD) of Topotecan when added to a fixed dose          regimen of Ifosfamide and Carboplatin in children and young adults with solid tumors.        -  To evaluate the toxicity associated with the administration of Topotecan with Ifosfamide          and Carboplatin (TIC) in children and young adults with solid tumors.      Secondary Objectives:        -  To evaluate the duration of neutropenia (ANC<500/micro L) and thrombocytopenia (PLT          50,000/ micro L and 20,000/ micro L) and the number of days of platelet transfusion          during each course of TIC chemotherapy when used in conjunction with G-CSF and NEUMEGA          in children and young adults with solid tumors.        -  To determine the median number of apheresis collections as well as the CD34/kg, CD41/kg,          CD61/kg and CD34:41/kg and CD34:61/kg per collection in patients electively undergoing          concurrent apheresis for peripheral blood stem cell collection in courses 2 or 3.        -  To determine the median number of peripheral blood mononuclear cells (PBMC) and ex-vivo          expanded myeloid dendritic cells (DC) in patients electively undergoing concurrent          apheresis for PBMC collection in courses 2 or 3.   "
203347|NCT00502905|"     Primary Objectives:        1. To administer multiple doses of an intravenous formulation of busulfan (Bu) at a dose          adjusted to yield a blood drug level with a median daily area under the plasma          concentration curve (AUC) of approximately 6,500 µMol-min. This dose will be given          intravenously over three hours once daily for four (4) days, in combination with          Fludarabine at a dose of 40 mg/m2 as preparation for bone marrow or peripheral stern          cell transplantation in patients with acute myeloid leukemia or myelodysplastic          syndromes.        2. To determine the outcome of Acute Myeloid Leukemia (AML)/myelodysplastic syndromes (MDS)          patients undergoing treatment with this regimen. Data regarding engraftment, toxicity,          relapse rate, long-term (disease-free) outcome, and overall survival will be collected.        3. To determine the safety profile of this regimen when utilized as preparation for          allogeneic transplantation.        4. To describe the plasma pharmacokinetics of busulfan when administered intravenously in          this regimen.   "
203349|NCT00502931|"     With the number of individuals becoming overweight or obese, healthcare professionals are in     need of accurate, reliable, and convenient tools to help personalize weight loss programs.     Recently, a new indirect calorimeter (i.e. MedGem / BodyGem; aka “Gem”) was introduced as a     convenient solution to determine resting metabolic rate (RMR) for assessment of daily energy     needs. Several validation and comparison studies were conducted to determine if the Gem     device is accurate and reliable. The purpose of this study was to conduct a systematic review     of previous studies that evaluated the accuracy and reliability of the Gem devices.   "
203350|NCT00502944|"     This study will compare the effectiveness of two different approaches to providing routine     HIV counseling, testing, and referral services in an urban hospital emergency department     setting.   "
203351|NCT00502957|"     The purpose of this randomized, controlled trial is to examine how well biofeedback treatment     works to improve constipation. The study is comparing two kinds of biofeedback treatment: 1)     anorectal-specific biofeedback therapy and 2) generalized biofeedback therapy using     relaxation techniques.      The study will also examine which medical and psychological factors determine biofeedback     success for treating constipation, such as bowel habits, emotional reactions to constipation,     and levels of stress and psychological distress.   "
203352|NCT00502970|"     To determine if a shorter course of interferon and ribavirin therapy will be sufficient in     carefully selected patients with chronic hepatitis C virus genotype 3 infection, as compared     to the standard length of treatment of 6 months.   "
203365|NCT00503139|"     The special use-results surveillance is conducted in patients who have never been treated     with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use     after marketing with the following objectives: 1. To examine the safety of long-term use of     Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in     the long-term use.   "
203353|NCT00502983|"     Little is known about the epidemiologic risk factors associated with the development of acute     myelogenous leukemia (AML), and less is known about the role that genetic susceptibility     plays in the development of AML. We propose to conduct a population-based study to     investigate genetic susceptibility in adult AML patients, both de novo and treatment-related     in a well-defined geographical area. Using a case-control design, we will prospectively     enroll 400 patients from Texas and 800 healthy controls. Controls will be recruited using     random digit dialing, and will be matched to the cases by age, gender, and ethnicity.     Epidemiological and demographic information will be obtained through personal interviews, and     will be integrated with clinical information, cytogenetic data, and genotypic markers. Blood     specimens will be collected on all participants, who will be genotyped for markers associated     with activation and detoxification of chemical carcinogens, including chemotherapy drugs.     Polymorphisms in genes such as cytochrome p450 (CYP2E1), glutathione S-transferases (GSTT1,     GSTM1, GSTP1), epoxide hydrolase (HYL1), NADPH-quinone oxidoreductase (NQO1), and     myeloperoxidase (MPO) will be analyzed.      This study will provide insight into the role that these susceptibility markers, along with     clinical epidemiological, and cytogenetic factors, play in the identification of people at     risk of developing AML. Understanding how genetic predisposition and exogenous exposures     interact to determine AML susceptibility will allow the development of prevention strategies     in the future.   "
203354|NCT00502996|"     This single arm study will assess the safety of MabThera plus methotrexate in patients with     rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents.     Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate     >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target     sample size is 100-500 individuals.   "
203355|NCT00503009|"     This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain     clinic visits will include a physical examination, lung function tests, inflammatory cell     analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA     approved virus through their nose which is known to cause the common cold. All study related     medications and medical examinations will be provided at no cost to the subject. The drugs     used in this study are approved for the age group under study.   "
203356|NCT00503022|"     This study evaluates the tolerability and safety of a single intravenous infusion of ACZ885.     It also explores the efficacy of the compound in central macular edema and visual acuity in     patients with wet age-related macular edema.   "
203357|NCT00503035|"     Primary Objective:        -  To determine whether celecoxib downregulates GATA-6 expression to upregulate 15-LOX-1          expression and induce apoptosis in human rectal tumors, researchers will measure GATA-6          and 15-LOX-1 expression, 13-S-HODE levels, and apoptosis rates in normal and colorectal          polyp epithelial tissues before and after 6 months of celecoxib treatment of patients          with familial adenomatous polyposis (FAP).   "
203358|NCT00503048|"     There are many studies regarding possible causes of increasing trend in frequency of allergic     diseases in the last three decades. Main causes of this trend are: decrease of infectious     diseases frequency, improvement in life level, changes in diet and lactic acid bacterias     elimination from digestive tract. Primary Purpose of this study is to compare the prevalence     of atopy and atopic diseases in two child populations: foster care and reference children and     - to define risk and protective factors for the development of atopy.   "
203359|NCT00503061|"     To investigate how common it is that patients using Symibort SMART take high average daily     doses that are not considered appropriate by their physician (overuse) or are hospitalised     due to their asthma at least partly due to underuse.   "
203360|NCT00503074|"     The purpose of this study is to determine whether a reduction in toddlers' and preschoolers'     exposure to television advertising leads to a change in their diet.   "
203369|NCT00503191|"     The purpose of this study is to determine whether NeuroModulation Technique (NMT) is     effective in reducing maladaptive behaviors and increasing adaptive behaviors in children     diagnosed with autism.      Hypothesis: Children in the Experimental group will show significant improvement over the     Wait-List control group as measured by the Pervasive Developmental Disorder Behavioral     Inventory (PDDBI), the Aberrant Behavior Checklist, Community Version (ABC-C), and the Autism     Treatment Evaluation Checklist (ATEC). Children in the Wait-List control group will show     significant improvement over their baseline measures after receiving NMT treatment.   "
203361|NCT00503087|"     Each participant will be administered 2 injections of saline - the first in the right gluteal     area and the second in the left gluteal area. Both injections will be administered     intra-muscularly by the same clinician. One injection will be given with vacuum (Pneumatic     Skin Flattening or PSF Machine) and the other without vacuum. The order of the injections     will be randomly assigned. Each subject will serve as a control for himself. Between     injections a 30 min pause will be given to minimize pain sensation bias of the previous     injection. Immediately after each injection the pain level will be assessed by the VAS scale.     The researcher assessing the pain will be blinded for the type of injection given. The     evaluation of the pain reduction will be made by comparison of the pain level with and     without the application of the PSF.      Hypothesis: PSF Technique will reduce the pain associated with saline injections.   "
203362|NCT00503100|"     Background: Several studies have indicated that infants who had undergone postnatal painful     procedures appear to be hypersensitive to pain, with a lower threshold to tactile     stimulations later on life.      Objective: To study the effect of early exposure to pain on cerebral somatosensory evoked     potential (SEP) response to thermal stimulation (550C), in preterm and full term born     adolescents (15-18 years old), who have undergone painful procedures during their neonatal     period. As well as to study the effect of early exposure to thermal and tactile sensory     thresholds and pain thresholds to thermal and tactile stimuli, by using the TSA and von Frey     hairs.      Design: Case-control study.      Participants: Four groups of 20 adolescents (aged 15-18 years), two of which are full term     and preterm-born who were exposed to painful procedures during the neonatal period. The other     two groups are term and preterm-born adolescents who were not exposed to such procedures.      Main Outcome Measures: Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal     stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation     threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer     (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by     using Von-Frey hairs.   "
203363|NCT00503113|"     This 3 arm study will evaluate renal safety after administration of an intravenous (iv)     injection or infusion of Bonviva, compared to oral alendronate, in patients with     postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized     to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months,     or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12     months, and the target sample size is 500+ individuals.   "
203364|NCT00503126|"     Pharmacokinetics and safety of weight based bivalirudin in children   "
203366|NCT00503152|"     In people with type 2 diabetes, microalbuminuria is a strong, independent risk factor for     diabetic nephropathy and cardiovascular morbidity and mortality. ACE inhibitor therapy     decreased the risk of microalbuminuria in hypertensive subjects with type 2 diabetes and     normoalbuminuria by about 40%. Available data suggest that angiotensin II receptor blockers     (ARBs) might have a similar renoprotective effect and that this effect might be increased by     combined ACE inhibitor therapy.      The study will evaluate the effects, at similar blood pressure control (systolic/diastolic     <130/80 mmHg), for a period of three years, of dual renin-angiotensin-system (RAS) blockade     by benazepril and valsartan combination therapy as compared to single RAS blockade by     benazepril or valsartan alone on microalbuminuria and cardiovascular events in high-risk     patients with type 2 diabetes, creatinine <1.5 mg/dl, no evidence of microalbuminuria but at     high risk of renal disease, with hypertension and a urinary albumin excretion between 7 and     19 microgram/min. The relationship between albuminuria and cardiovascular outcomes will also     be evaluated.      The study is expected to show a more effective prevention of microalbuminuria and     cardiovascular events with combined than with single drug ACE inhibitor or ARB therapy. As     compared to ACE inhibitor, ARB therapy is expected to have a similar effect on     microalbuminuria, but an inferior cardioprotective effect. Applied to clinical practice, the     findings should help preventing renal and cardiovascular complications, and related treatment     costs, of type 2 diabetes.   "
203367|NCT00503165|"     Menitorix is a combined Hib conjugate and meningococcal C conjugate vaccine made by     GlaxoSmithKline. It is currently licensed and recommended as a booster vaccination for UK     children in the second year of life.      It is important that staff who have a potential occupational exposure to infectious disease     are afforded protection where possible. The licensure and availability of Menitorix provides     the opportunity to vaccinate such staff.      Immune responses that are indicative of protection have been established for both Hib and     meningococcal C disease. It is therefore proposed that the immune responses of those     laboratory staff taking part be measured as data currently available following Menitorix     vaccination is in naïve children and adults. This study will also allow us to provide     occupational healthcare to laboratory workers.      Participation in the study would be offered to all those staff considered to be at     occupational health risk of Hib or meningococcal C disease at the Manchester HPA site. This     will be a single group study in that everyone enrolled will receive a single dose of     Menitorix and will have blood collected prior to and 4-6 weeks following vaccination.      Assessment of whether protective levels of antibody have been achieved will be made using the     blood sample taken 4-6 weeks after vaccination. Extra dose(s) will be offered to any subjects     whose levels are not considered to confer protection as described later in this protocol.     Subjects receiving and extra vaccination will be offered and a further blood test 4-6 weeks     later to allow antibody levels to be checked again.   "
203368|NCT00503178|"     Highly selective irradiation requires accurate target definition by high-resolution     three-dimensional imaging. Co-registration of FDG-PET and high-resolution CT might be the     imaging modality of choice. This choice might target radiation therapy precisely to the     intra-osseous volume that is responsible for pain and to spare selectively healthy bone in     the vicinity of the metastasis. This strategy could result in equal anti-pain efficacy as     conventional large volume radiotherapy, but could allow bone remodeling and preservation of     bone structural strength in the vicinity and could lead to reduced toxicity to neighboring     organs.   "
203370|NCT00503204|"     This is a Phase I, open-label, multi-centre study designed to assess the safety and     tolerability of Cediranib in combination with lomustine in patients with primary recurrent     malignant brain tumour.   "
203371|NCT00503217|"     The aim of this study is to assess whether GnRH agonist administration in the luteal phase     improves pregnancy outcome in intrauterine insemination (IUI) cycles.   "
203372|NCT00503230|"     The purpose of this study is to develop and evaluate a brief clinic-based culturally tailored     smoking cessation treatment for a largely low-income, Latino, HIV+ population. We will     compare this Culturally-Tailored Intervention (CTI) that incorporates a strong social support     component and is targeted to the special needs and concerns of a Latino population to a     Standard Care Intervention (SCI) control condition, in a randomized controlled trial. We     hypothesize that those Latinos receiving the CTI will demonstrate greater biochemically     verified smoking abstinence rates at 12-months post-baseline than those receiving the SCI     control treatment. All study participants and their participating social supports will be     offered use of the nicotine patch.   "
203373|NCT00503243|"     The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given     twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in     subjects with acute, mild to moderate ulcerative colitis.   "
203389|NCT00509158|"     Malaria is responsible for over 2 million deaths each year. The development of an efficient     vaccine would present by far the best solution for solving this disastrous situation.     Liver-Stage-Antigen-3 (LSA-3) is an antigen that is mainly exhibited by Plasmodium falciparum     sporozoites and liver-stage parasites. It is characterized by its remarkable antigenicity in     humans with a wide range and a variety of B and T-lymphocyte epitopes, by its extremely high     immunogenicity and by an excellent protective efficacy against sporozoite challenge in animal     models. Therefore, PfLSA-3-rec is a promising candidate vaccine against P. falciparum in     humans The aim is to screen two different formulations of the recombinant malaria vaccine     PfLSA-3-rec, one adjuvated with aluminium hydroxide and one with Montanide Isa 720, by     assessing the safety and immunogenicity (phase I) profile of each formulation in humans, as     well as its protective efficacy following a sporozoite challenge (phase IIa).   "
203390|NCT00509171|"     The purpose of this study is to determine the effect on the incidence of fat emboli when     using a Reamer-Irrigator Aspirator during reamed IM nail fixation of femoral shaft fractures   "
203374|NCT00503256|"     The goal of this research is to identify genes that may be related to the risk of developing     CLL.      Objectives:      The objective of this study to investigate possible candidate susceptibility genes for     familial chronic lymphocytic leukemia (CLL) by identifying and recruiting high-risk families.     Through our ongoing study of familial aggregation in CLL kindreds (protocol 2003-0498     'Genetic Study of Chronic Lymphocytic Leukemia'), we have identified CLL patients who have     one or more living or dead relative(s) affected with CLL or other leukemias or lymphomas. We     will also identify patients in high-risk families from referrals from leukemia clinicians and     from self-referrals from patients who learn about our study from the ClinicalTrials.gov     website. We plan to invite probands (patients diagnosed with CLL) and their family members     with other leukemias and lymphomas and a sample of unaffected relatives to participate in a     genetic/linkage study. We will obtain demographic and clinical information along with     specimens (blood or buccal samples) from all participants. These families will be part of the     Genetic Epidemiology of CLL Consortium, a multicenter, multidisciplinary consortium, based at     the Mayo Clinic Cancer Center under the direction of Susan Slager, PhD. This is funded from     NCI through a subcontract with Mayo Clinic.      Genotypic data will be analyzed at Mayo Clinic, and coded, de-identified data will be shared     with the NIH Genome-Wide Association Studies (GWAS) data repository.   "
203375|NCT00503269|"     Background: Local anaesthetic day-care open haemorrhoidectomy (LH) is feasible, cheap and may     be the cost-effective surgical approach to third degree haemorrhoids. This prospective     randomised controlled trial compares patient's evaluation of LH with general anaesthetic     day-care Park's modified Milligan-Morgan haemorrhoidectomy (GH).      Methods: 41 patients with third degree haemorrhoids were randomised to LH (19 cases) and GH     (22 cases). Demographics were comparable. Independent assessment (by a research nurse) and     clinical evaluation ran parallel for 6 months. Outcome measures were average and expected     pain scores for 10 days; satisfaction scores at 10 days, 6 weeks and 6 months. Secondary     outcomes were journey time and cost in day surgery.   "
203376|NCT00503282|"     In the era of emerging antibiotics resistant microbiology, we look for better outcome in the     treatment of infections in the elderly.      We look for guidelines to manage an elderly who has a permanent urinary catheter, admitting     to E.R. with Fever/Sepsis.      We assume that exchanging the permanent urinary catheter prior to the Urine Culture sample as     well as for initiating antibiotic treatment will improve the outcome of the patients.It could     help the day-to-day fight for the proper antibiotics treatment to avoid resistance.   "
203377|NCT00503295|"     The purpose of this Phase 2 study is to investigate whether intravenous administration of     REOLYSIN® therapeutic reovirus is safe and effective in the treatment of patients with bone     and soft tissue sarcomas metastatic to the lung.   "
203378|NCT00503308|"     The purpose of the study is to determine whether an abbreviated pretest/post-test CDC     recommended counseling is as equally acceptable to prenatal patients as the standard strategy     using prenatal care nurses and medical providers at San Francisco General Hospital [SFGH]).   "
203379|NCT00503321|"     A randomized controlled study is conducted on unresectable advanced gastric carcinoma and     recurrent gastric carcinoma to compare TS-1 therapy with TS-1 + PSK therapy. The primary     endpoint of this study is progression-free survival (PFS), with secondary endpoints of     anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug     reactions and immunological factors.   "
203380|NCT00503334|"     The purpose of this pilot study is to investigate the effect of an oral nutritional     supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing     elective pancreaticoduodenectomy.   "
203381|NCT00503347|"     This trial is designed to assess the safety, tolerability, pharmacokinetics and viral     kinetics after multiple infusions of bavituximab in patients co-infected with HCV and HIV.   "
203382|NCT00503360|"     This study will evaluate the tolerability and safety of SAD448 and explore the compound's     effect on intraocular pressure in subjects with ocular hypertension.   "
203383|NCT00503386|"     The purpose of this study is to determine whether palonosetron is tolerate and effective in     preventing chemotherapy-induced nausea and vomiting in oriental population. The study is     comparing the safety and efficacy of palonosetron with granisetron, a frequently used     antiemetic in China.   "
203384|NCT00509093|"     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating     patients with newly diagnosed acute myeloid leukemia who have received chemotherapy.   "
203385|NCT00509106|"     The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective     in the treatment of community-acquired pneumonia in adults.   "
203386|NCT00509119|"     This is a study on how acute clinical state and final clinical outcome in patients with     stroke (exclusive subarachnoid hemorrhage) relate to ICP/ABP-derived pressure waveform     parameters recorded during intensive care management.   "
203387|NCT00509132|"     The purpose of this study is to evaluate the safety and tolerance of single intravenous     (through a vein) doses of trodusquemine. Different amounts of trodusquemine will be given to     each volunteer group throughout the study. Another purpose is to evaluate the     pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues     over time) of trodusquemine. Finally, this study will also determine whether trodusquemine     has any effect on appetite, mood or behavior, and selective biomarkers (substances in your     blood that may change in response to the study drug).   "
203388|NCT00509145|"     Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as     compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).   "
203391|NCT00509184|"     Combination of involved field radiotherapy for the control of macroscopic disease and CD20     antibody Rituximab for the control of microscopic remainders in other regions in patients     with early stage nodal follicular lymphoma /grade I or II). Evaluation of DFSl and toxicity.   "
203463|NCT00510822|"     This multicenter study aims to investigate the safety and efficacy of cimicoxib, a selective     COX-2 inhibitor, in combination with sertraline compared to sertraline combined with placebo     in patients with major depression. This clinical study is based on the assumption that     adjunctive treatment of major depression with a COX-2 inhibitor may be beneficial.   "
203392|NCT00509197|"     The efficacy of inhaled corticosteroids (ICS) in asthmatic subjects showing no sputum     eosinophils is controversial. The broad aim of this study is to assess whether ICS alone or     in combination with long-acting beta-2 agonists are an effective treatment in     non-eosinophilic asthmatic subjects. Methods: The investigators will perform a randomized     double-blind, placebo-controlled, multicenter study comparing the efficacy of ICS and placebo     for 4 weeks followed by a 4-week open treatment period with ICS/salmeterol in steroid-naïve     asthmatic subjects without sputum eosinophilia. The primary outcome will be the the Asthma     Control Questionnaire (ACQ) score after four weeks of treatment by ICS or placebo.      This study will determine whether or not non-eosinophilic asthmatic subjects respond to ICS     and if they further benefit from the addition of a long-acting beta-2 agonists. This study     will also determine whether or not the assessment of airway inflammation should be performed     in every asthmatic patient in order to give the most appropriate treatment.   "
203393|NCT00509210|"     The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir     following administration of multiple oral doses to subjects with moderate and severe hepatic     impairment.   "
203394|NCT00509223|"     Obstructive Sleep Apnea (OSA) and type 2 diabetes mellitus are two prevalent medical     conditions with significant associated cardiovascular and cerebrovascular morbidity and     mortality. Research indicates that the prevalence of OSA is increased in diabetic patients     when compared with normoglycemic patients and that OSA is independently associated with type     2 diabetes. Further research suggests that effective treatment of the OSA with continuous     positive airway pressure (CPAP) improves insulin responsiveness in both non-diabetic OSA     patients and diabetic-OSA patients. We are proposing a clinical trial to evaluate the impact     of 6 months of CPAP therapy on glycemic control in type 2 diabetic patients with OSA.      The primary objective of this study is to assess the effectiveness of CPAP in improving     glycemic control (HbA1c) in type 2 diabetic patients with newly diagnosed OSA. Secondary     objectives of this study include: assessment of fasting and post prandial glucose,     determination as to whether there are any biochemical markers for OSA in the type 2 diabetic     population; assessment of any improvements in cardiovascular outcomes; evaluation of any     improvement in quality of life. Patients with OSA will be randomized into one of two groups:     either a CPAP treatment group or a non-treatment group. Patients will be followed at 3 months     and 6 months with collection of various lab tests to assess glycemic control.   "
203395|NCT00509236|"     The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in     participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who     do not have adequate glycemic control.   "
203396|NCT00509249|"     This phase II trial is studying how well aflibercept works in treating patients with     myelodysplastic syndromes. Aflibercept may be able to carry cancer-killing substances     directly to myelodysplastic syndrome cells. It may also stop the growth of cancer cells by     blocking blood flow to the cancer   "
203397|NCT00509262|"     The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose     levels in participants with moderate or severe renal insufficiency.   "
203398|NCT00509275|"     In this phase Ib, multi-centre, randomized, double-blind, placebo-controlled parallel group     study, 120 subjects with moccasin type tinea pedis (MTTP) will be enrolled at approximately     11 centres in the USA, Canada and Australia.      The primary objective of the study is to assess the patient response to three W0027 regimens     in subjects with MTTP. Secondary objectives include assessment of the safety, tolerability     and skin and nail pharmacokinetics to the three Albaconazole regimens.   "
203415|NCT00510198|"     The purpose of the PRECEDE-HF study is to collect data to compare patients whose heart     failure is managed using Cardiac Compass with OptiVol (which is a tool in the device that     records information about the heart that doctors can use to help treat their heart disease)     combined with standard treatment methods (Access Group) to patients whose heart failure is     managed by standard treatment methods only (Control Group). This comparison will show if the     additional monitoring provided by Cardiac Compass with OptiVol delays the time patients are     first admitted to hospital for heart failure or delays the time to death.   "
203416|NCT00510211|"     The primary objective of this study is to assess the proportion of schizophrenic patients and     the proportion of bipolar patients who discontinue olanzapine within 12 months of treatment     in outpatient, ambulatory or community settings   "
203399|NCT00509288|"     Background:        -  Human peripheral blood lymphocytes have been engineered to express a T-cell receptor          (TCR) that recognizes a blood type,HLA-A 0201 (human leukocyte antigen) derived from the          gp100 protein. A retroviral vector was constructed that can deliver the T-cell receptor          (TCR) to cells.        -  Patients' cells will be converted into cells able to recognize and fight melanoma          tumors.      Objectives:        -  To determine whether TCR-engineered lymphocytes can be put in cells removed from          patients' tumors or blood and then reinfused, with the purpose of shrinking tumors.        -  To evaluate safety and effectiveness of the treatment.      Eligibility:        -  Patients 18 years of age or older with metastatic cancer melanoma (cancer that has          spread beyond the original site).        -  Patient's leukocyte antigen type is HLA-A 0201.      Design:      -Patients undergo the following procedures:        -  Leukapheresis (on two occasions). This is a method of collecting large numbers of white          blood cells. The cells obtained in the first leukapheresis procedure are grown in the          laboratory, and the anti-MART-1 protein is inserted into the cells using an inactivated          (harmless) virus in a process called retroviral transduction. Cells collected in the          second leukapheresis procedure are used to evaluate the effectiveness of the study          treatment.        -  Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1          hour for 2 days to suppress the immune system so that the patient's immune cells do not          interfere with the treatment.        -  Treatment with anti-melanoma antigen recognized by T-cells (MART)-1. Patients receive an          intravenous (IV) infusion of the treated cells containing anti-MART-1 protein, followed          by infusions of a drug called IL-2 (aldesleukin), which helps boost the effectiveness of          the treated white cells.        -  Patients are given support medications to prevent complications such as infections.        -  Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue).        -  Patients are evaluated with laboratory tests and imaging tests, such as CT (computed          tomography) scans, 4 to 6 weeks after treatment and then once a month for 3 to 4 months          to determine the response to treatment.        -  Patients have blood tests at 3, 6, and 12 months and then annually for 5 years.   "
203400|NCT00509301|"     RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine     131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor     cells and deliver radiation directly to the center of the tumor mass while minimizing effects     on normal tissues. Cotara® thus literally destroys the tumor from the inside out. This may     be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.      PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients     with recurrent glioblastoma multiforme.   "
203401|NCT00509314|"     The aim of this study is to survey melanocytes in the ability of self-assembly on     biomaterials and functional analysis in vitro. Also, this study may provide a better way for     treatment of vitiligo after understanding the functional aspects of melanocytes.   "
203402|NCT00509327|"     Postoperative bowel dysmotility is a frequent condition after colorectal surgery. The     influence of colon stimulating laxatives have not been studied. This prospective, randomized,     double blind, placebo controlled study assesses the influence of bisacodyl on postoperative     bowel motility in patients undergoing elective colorectal surgery. The hypothesis of this     trial was that bisacodyl has a beneficial effect on the duration of postoperative ileus.   "
203403|NCT00509340|"     This study will compare the effectiveness of a cognitive behavioral intervention versus usual     clinic care in helping HIV infected adults with depression to take their HIV medications on     schedule.   "
203404|NCT00509353|"     RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIGB), may carry     radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such     as irinotecan and vincristine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving iodine I 131 MIGB     together with irinotecan and vincristine may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 MIGB     when given together with irinotecan and vincristine in treating young patients with resistant     or relapsed high-risk neuroblastoma.   "
203405|NCT00509366|"     In this trial, subjects with chemo-naive advanced non-small cell lung cancer (NSCLC) were     assigned to chemotherapy using a genomic-based predictor for platinum sensitivity. After an     amendment dated 1/25/2010, subjects with squamous cell NSCLC sensitive to cisplatin received     cisplatin/gemcitabine and if resistant to cisplatin received docetaxel/gemcitabine. Subjects     with non-squamous cell NSCLC sensitive to cisplatin received cisplatin/pemetrexed and if     resistant to cisplatin received pemetrexed/gemcitabine. The primary objective of this trial     was to prospectively validate the genomic-based prediction model through separate evaluation     of the one-year progression-free survival (PFS) of the cisplatin-sensitive and     cisplatin-resistant cohorts. Secondary objectives included: assessment of overall time to     progressive disease, quality of life and evaluation of drug sensitivity patterns of cisplatin     and pemetrexed.   "
203406|NCT00509379|"     The promising activity of Bortezomib as single agent in low grade lymphoma patients in small     studies has led to a number of larger multicenter trials with Bortezomib in combination with     Rituximab in mantle-cell lymphoma, follicular lymphoma and marginal zone lymphoma.   "
203407|NCT00509392|"     The objective of this post-market study is to compare the post-procedure recovery between two     types of minimally invasive catheter treatments for venous disease in the Great Saphenous     Vein.   "
203408|NCT00509405|"     Hypothesis: Neutralization of acid production induced by the Western diet with oral     administration of potassium citrate increases bone mineral density and bone mass as well as     skeletal muscle mass and strength in elderly people (> 65y).   "
203409|NCT00509418|"     The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in     combination with diet and exercise improve the histological results (steatosis,     necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24     weeks of treatment.   "
203410|NCT00510133|"     This is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy     with GRNVAC1 in patients with AML.   "
203411|NCT00510146|"     The purpose of this study is to assess whether olanzapine is superior to placebo in patients     with bipolar depression.   "
203412|NCT00510159|"     The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP     (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian     children. The nul-hypothesis in this study is that the combination of As+SMP is more     effective than praziquantel in the treatment of S. haematobium infected children.   "
203413|NCT00510172|"     We hypothesised that intravenous infusion of PGI2 induced headache or migraine and cranial     vasodilatation in migraineurs.   "
203414|NCT00510185|"     A randomized study comparing an early aggressive with an initially conservative strategy in     patients >74 y.o. with non-ST-elevation acute coronary syndrome.      This study had generated a secondary one:      Causes of death in elderly patients with Non-ST-Elevation Acute Coronary Syndrome;     predictors of in-hospital and follow-up death   "
203417|NCT00510224|"     This is an open label, single center Phase II trial of Sandostatin LAR in patients with     hormone refractory prostate cancer. Patients will receive Sandostatin LAR 30 mg     intramuscularly every 28 days. Patients will be treated until the time of disease     progression, unacceptable toxicity or withdrawal of consent. The study will require 27     evaluable patients.   "
203418|NCT00510237|"     This study will pilot test an HIV intervention for newly diagnosed youth (diagnosed for less     than 15 months) to assess its acceptability and feasibility preliminary to and leading up to     a full-scale, randomized trial. The general focus of the intervention is to aid in the     psychosocial adjustment of adolescents who have recently been diagnosed with HIV.   "
203419|NCT00510250|"     This will be a multi-institution, single-arm, open-label, phase I/II trial. Eligible patients     will have pathologically-proven T1b-3b, N0/1, M0 epithelial carcinoma of the cervix. We     hypothesize that sorafenib in combination with chemotherapy and radiotherapy may have     anti-tumor activity in patients with cervical cancer. Sorafenib has not previously been     combined with conventional RT-CT to treat cervix cancer.   "
203420|NCT00510263|"     The main objective of this study is to study the effects of prednisolone and valaciclovir,     with equal importance, compared to placebo for the treatment of Bell´s palsy. The combination     of prednisolone and valaciclovir will also be studied.   "
203421|NCT00510276|"     This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity     disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults.      A gatekeeper strategy will be employed for sequentially testing the secondary objectives.      This study also has an observational community sample arm in which patients will complete all     the efficacy measurements via web-based self reporting.   "
203464|NCT00510835|"     The ProCESS study is large, 5-year, multicenter study of alternative resuscitation strategies     for septic shock. The study hypothesizes that there are golden hours in the initial     management of septic shock where prompt, rigorous, standardized care can improve clinical     outcomes.   "
203422|NCT00510289|"     The purpose of this study is to evaluate the efficacy of sorafenib in patients with     Myelodysplastic Syndrome (MDS). Eligible subjects will receive Sorafenib administered at     400mg orally twice a day, given on days 1-28 of a 28-day cycle. Patients will be evaluated     for hematological response after 2 cycles and then every 3 cycles thereafter for a maximum of     5 years from study entry. If a patient achieves a complete response they may receive an     additional 6 cycles of therapy beyond documentation of complete response unless unacceptable     toxicity occurs. For patients with partial response, hematological improvement or stable     disease they will continue treatment until relapse, progression of disease, or unacceptable     toxicity occurs.   "
203423|NCT00510302|"     Primary Objectives:        -  To conduct semi-structured interviews with melanoma patients and family members to          collect descriptive information on their UVR exposure, UVR exposure-reduction practices,          melanoma early detection practices, knowledge, psychosocial variables related to          melanoma risk-reduction (e.g., self-efficacy, norms, and expectations), and experiences          surrounding the diagnosis of melanoma in the family. Melanoma patients and family          members with children will be asked about the UVR exposure and UVR exposure-reduction          practices of their children, and parental practices to reduce UVR exposure among          children.        -  To develop behavioral and attitudinal questionnaires based on data collected during          semi-structured interviews, and evaluate the appropriateness of these questionnaires          using cognitive interviewing techniques.        -  To develop tailored messages aimed at promoting strategies to reduce UVR exposure (e.g.,          wearing protective clothing, minimizing midday UVR exposure, minimizing duration of UVR          exposure, using shade and sunscreen, avoiding sun lamps, and avoiding intentional          tanning) and improving adherence to surveillance and screening guidelines. Messages will          be developed to correspond to responses to questionnaire items.        -  To assess tailored messages for their relevance, appropriateness, attractiveness and          appeal, credibility, and perceived behavioral impact among melanoma patients and their          family members.   "
203424|NCT00510315|"     The purpose of this study is to better understand why some women who survived cancer or a     related illness later develop diabetes, problems with their cholesterol, or other problems     that may lead to heart disease. Because these problems may be related to treatment with total     body irradiation and a stem cell transplant, the investigators will compare the rates of     obesity, cholesterol problems, and diabetes between women who were treated with total body     irradiation and a stem cell transplant and women who were not.      The amount and location of fat stores in the abdomen is more important than overall weight or     total body fat in the development of diabetes and cholesterol problems. In general, fat can     be stored in several areas in the abdomen: around the organs (visceral fat), under the skin     (subcutaneous fat), and in the liver (liver fat). People with higher amounts of fat around     the organs (visceral fat), even those with a normal weight, are more likely to become     diabetic or have high cholesterol. The amount of fat in each of these areas can be measured     with an abdominal magnetic resonance imaging (MRI).      In this study, the investigators will use blood tests, height, weight, waist circumference,     blood pressure measurements, and an abdominal MRI to evaluate for several risk factors of     heart disease, including cholesterol problems, diabetes and pre-diabetes, elevated blood     pressure, and increased abdominal fat.   "
203425|NCT00510328|"     The purpose of this study is to determine the effects of whole body vibration therapy on     muscle firing patterns as measured by EMG analysis.   "
203426|NCT00510341|"     Self-care behaviors are decisions and actions that people can take to improve their health or     cope with a health problem. It is important for people with long-term illnesses to develop     and maintain effective self-care behaviors. This study will evaluate the usefulness and     practicality of the Collaborative Management in Pediatrics (CMP) program, which is a training     program developed to encourage pediatric resident doctors to promote self-management of     illness and behavior change among children with asthma or obesity and their families.   "
203427|NCT00510354|"     The purpose of this multicenter, single-arm, Simon two-stage, phase II trial is to determine     the efficacy and safety of everolimus in combination with Imatinib mesylate in patients with     previously treated, histologically proven GIST whose disease has recurred or progressed while     receiving 400 mg/day of Imatinib mesylate at any time during at least a 2 months' treatment     period.   "
203428|NCT00510367|"     The goal of this clinical research study is to learn the results of multimodality     (chemotherapy, surgery and radiation therapy) treatment of primary breast cancer that occurs     at the same time as pregnancy. Researchers want to evaluate the outcome of labor and delivery     as well as evaluate the long-term health outcomes of children exposed to chemotherapy while     in their mother's womb.   "
203429|NCT00510380|"     This study is carried out to discover if a baby with restricted growth in the womb is subject     to specific fetal programming which predisposes to the metabolic     syndrome(diabetes,hypertension,heart disease) in adulthood.We have elected to first study     this condition in Chinese population in Singapore with the eventual plan of studying all     ethnic groups. This is important for understanding the molecular basis of adult-onset disease     such as diabetes, identifying children at risk of developing this disease in future and     targeting specific strategies for intervention and disease prevention.      Intrauterine fetal programming is effected through epigenetic changes similar to those     previously identified in animal studies. The epigenetic markers can be found in growth     restricted Chinese pregnancies in the local population.   "
203430|NCT00510393|"     The Destiny trial compares the use of bare metal stent systems with drug eluting stent     systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia.     It will be investigated whether there is a difference in 12 month angiographic patency of the     stented area using the 2 different stent systems.   "
203431|NCT00510406|"     The study will examine the efficacy,safety and tolerability of combination therapy of     tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin     in the treatment of males with LUTS associated with BPH.   "
203432|NCT00510419|"     The purpose of this research study is to evaluate an investigational auto-injector system for     delivering sumatriptan under the skin for a single migraine attack.      The study could take approximately 5 weeks and will include about 3 office visits to the     study doctor, the patient will be contacted every 2 weeks until the patient experiences a     migraine and uses the auto-injector. The last visit will be done by a telephone follow-up     call.   "
203433|NCT00510432|"     An increased number of patients with heparin-induced skin lesions is reported in the     literature. Heparin-induced skin lesions may result from either occlusion of cutaneous     vessels in patients suffering from autoimmune HIT or from a type IV allergic reaction     (delayed type hypersensitivity (DTH) response). However, the incidence and nature of     heparin-induced skin lesions has not been determined in a prospective investigation.      To address this open issue is the goal of this ongoing, so far monocenter, clinical     investigation.   "
203434|NCT00510445|"     The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of     GRN163L when administered in combination with a standard paclitaxel/carboplatin regimen to     patients with advanced or metastatic non-small cell lung cancer.   "
203435|NCT00510458|"     Total hip replacement surgery is considered to be a very successful surgical procedure for     the treatment of degenerative joint disease. The purpose of the study is to evaluate a large     size (36mm, 40mm or 44mm) femoral (hip) head called the LFIT™ Anatomic CoCr Femoral Head (Low     Friction Ion Treatment). The large size femoral heads will be used with the Trident® X3®     polyethylene (plastic) inserts and will be compared with a historical control. Study     Hypothesis: The linear wear rate for hips implanted with the LFIT™ Anatomic CoCr Femoral Head     is no worse than 0.08 mm wear per year at 5 years post-surgery.   "
203436|NCT00510471|"     The treatment being investigated is a patient- and tumor-specific therapy known as a     personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a     person's own immune system to combat disease. Sargramostim (a.k.a. GM-CSF) is given together     with the personalized active immunotherapy because it may increase the immune system's     response and, therefore, aid in the effect of the personalized active immunotherapy.      This approach has previously been studied in patients with follicular Non-Hodgkin's lymphoma     and other B-cell malignancies. Encouraging efficacy results and a favorable safety profile     have been seen to date in these studies.   "
203437|NCT00510484|"     This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat     and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.   "
203438|NCT00510497|"     This study aims to look at the safety and tolerability of immunization with dendritic cell     vaccine prepared using the patient's own cells and virus. It also aims to explore the     virologic efficacy of the vaccine as determined by a decrease in the viral load 12 weeks     after analytic treatment interruption.   "
203439|NCT00510510|"     This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and     200 µg once a day, compared to placebo in patients with moderate or severe Chronic     Obstructive Pulmonary Disease (COPD).   "
203440|NCT00510523|"     The purpose of this investigation is to determine the effect of Whole Body Vibration Therapy     (WBV) on balance in participants with multiple sclerosis (MS) related balance deficits as     measured by the NeuroCom Balance Master, the Sapphire IIME EMG Device and the Kurtzke     Expanded Disability Status Scale (EDSS) and the Berg Balance Score.   "
203441|NCT00510536|"     The purpose of this study is to evaluate tolerability and effectiveness of conventional     treatment for mild to moderate arthritic or arthralgic symptoms while subjects are being     treated with efalizumab for psoriasis.   "
203442|NCT00510549|"     As the influence of type of dialysis on survival of end stage renal disease (ESRD) patients     remains unanswered, the present study is designed (randomized, prospective, multicenter,     interventional) to assess clinical outcomes, and compare mortality, morbidity, Quality of     Life (QOL) and cost effectiveness between maintenance In-center Hemodialysis (ICHD) and     Continuous Ambulatory Peritoneal dialysis (CAPD). These data will ultimately bring clarity on     whether or not any difference in patient survival exists between the two modalities.      In order to test the feasibility of patients' willingness to be randomized to two different     modality groups and retained in the randomized group, a pilot study is planned before the     conduct of a main study.      This pilot study comprises of a 6 months study, plus a 6 months observation if there is     possibility to switch the patients into the main study.      All ESRD patients requiring dialysis treatment within 8 weeks after a pre-study visit will be     recorded in each site. Patients who provide written inform consent for collecting relevant     information will be screened using certain inclusion/exclusion criteria. Eligible patients     will undergo a standardized education regarding ESRD and treatment options. Thereafter the     patient will be required to provide a second inform consent allowing for randomization and     entrance into the study. Eligible patient will be randomized to either PD or HD treatment.      The patients will be followed for a period of 6 months, during which patients will be treated     with PD or HD as prescribed at each site, while meeting the dialysis adequacy and other     indicators. For the first 3 months monthly visits are required, after which an every 3 months     visit is planned.      In this pilot study, the main objective is to assess the willingness of ESRD patients to be     randomized to either PD or HD treatment; thereby determining if an adequate number of     eligible patients can be recruited for a future large-scale study.   "
203443|NCT00510562|"     It is the purpose of this study to attempt to determine if there is an immediate, measurable     change in visual function as a direct result following a session of cranial osteopathic     manipulation.   "
203444|NCT00510575|"     There are two rod sizes routinely used for the correction of juvenile and adolescent     idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. Currently there is no     scientific evidence supporting the superiority of one size rod relative to the other. This     study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the     6.35mm spinal instrumentation rods.   "
203445|NCT00510588|"     Chronic inflammatory activation in fat tissue can be the link between adiposity and an     increased risk for atherosclerosis. Aim of the study is to investigate how molecular     alterations in fat tissue can be influenced by regular physical exercise training alone or in     combination with a medical therapy (Glitazon or Metformin) in obese patients with stable CAD     and impaired glucose tolerance.   "
203446|NCT00510601|"     A pilot study to examine the effects of LDL-Apheresis on patients with Stage III Congestive     Heart Failure.      Study hypothesis: Decreased blood viscosity from receiving LDL-apheresis will decrease     workload on the heart and improve symptoms associated with the progression of Congestive     Heart Failure   "
203460|NCT00510783|"     This study is looking at three seizure medicines. Patients with seizures are usually treated     with phenytoin (Dilantin) or Fosphenytoin. These medicines can be given intravenously (IV)or     by mouth. Another seizure medicine, levetiracetam (Keppra) can now be given this way also.     This study will compare IV phenytoin (Dilantin) and IV fosphenytoin to levetiracetam (Keppra)     in patients who have had a recent seizure. Only patients with a history of seizures can be     involved. The patient must present to the emergency department within 4 hours of a seizure.     The purpose of this study is to compare these three drugs, phenytoin (Dilantin),     fosphenytoin, and levetiracetam (Keppra). The investigators are looking to see if these drugs     can prevent another seizure in the next 24 hours. We are also looking for any possible side     effects.   "
203447|NCT00510614|"     This research study is being done to evaluate the use of an oral (by mouth) medication called     tinidazole to initially treat BV and then to see if additional treatment with tinidazole     keeps women from getting this infection back within 3 months. Tinidazole is currently     approved by the United States Food and Drug Administration (FDA) to treat bacterial vaginosis     (BV).      This study will evaluate the use of tinidazole to treat a woman's current BV infection and     then will look at using tinidazole as a suppressive treatment (taking medication regularly to     attempt to decrease the bad bacteria from growing back). The suppressive treatment phase     will include using tinidazole twice a week compared to using placebo twice a week and then     following women for recurrence of BV. The purpose of this study is to determine if tinidazole     suppression will prevent BV from coming back within 3 months of treatment.      The investigators hypothesize that women with a history of recurrent bacterial vaginosis who     are randomized to a suppressive regimen (a dose of medication given on a regular basis to     attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have     lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared     to those women randomized to placebo.   "
203448|NCT00510627|"     The purpose of this study is to determine whether patients treated with Radiofrequency     Ablation (RFA) in conjunction with chemotherapy have a better overall survival rate than     patients treated with chemotherapy alone.   "
203449|NCT00510640|"     Due to arguments showing that angiogenesis could be involved in progression of metastatic     thyroid carcinoma and to objective response during previous studies with sunitinib (an     angiogenic oncology drug also known as Sutent), this study, THYSU, is justified to evaluate     the efficacy of sunitinib in metastatic thyroid carcinoma. Furthermore, the standard     treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is     limited to radioiodine. When radioiodine becomes ineffective, there is no standard treatment     despite some use of chemotherapy.      The objective of the trial is to determine the objective tumor response rate (efficacy) in     patients with locally advanced or metastatic anaplastic, differentiated or medullary thyroid     carcinoma treated with sunitinib; a secondary objective is to evaluate the safety of     sunitinib in these patients.      The THYSU trial is a phase II, French multi-center study. This trial's plan is to enroll 75     patients with locally advanced or metastatic anaplastic, differentiated or medullar thyroid     carcinoma.   "
203450|NCT00510653|"     Primary Objectives:        1. To determine the efficacy of Gleevec in patients with recurrent platinum-resistant,          taxane-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube          cancer whose tumor expresses either c-KIT, platelet-derived growth factor receptor          (PDGRF), or ABL.        2. To determine the nature and degree of toxicity of Gleevec in this cohort of patients.   "
203451|NCT00510666|"     Intravenous patient-controlled analgesia (PCA) is a popular technique for postoperative pain     management. Although several drugs are recognized as effective therapeutic options, optimal     selection of drugs in hysterectomy patients underwent different anesthesia treatments remains     unknown explicitly. The investigators hypothesized that butorphanol and tramadol can produce     different analgesic effects with intravenous PCA after abdominal hysterectomy.   "
203452|NCT00510679|"     The objective of this study was to determine the effectiveness and cost-effectiveness of a     package of interventions to support health workers in Benin (in West Africa) who had been     trained to use Integrated Management of Childhood Illness guidelines (i.e., guidelines     intended to improve the treatment of childhood illnesses).   "
203453|NCT00510692|"     This purpose of this study is to investigate whether the number and size of rectal polyps can     be reduced in patients with Familial Adenomatous Polyposis (FAP) by using a highly-purified     form of a naturally occurring substance, the omega-3 fatty acid, eicosapentaenoic acid (EPA).   "
203454|NCT00510705|"     Chronic inflammatory activation in fat tissue can be the link between adiposity and an     increased risk for atherosclerosis. The aim of this study is to investigate how molecular     alterations in fat tissue can be influenced by regular physical exercise training alone or in     combination with a medical therapy (glitazone or metformin) in obese patients with severe     coronary artery disease (CAD) and impaired glucose tolerance.   "
203473|NCT00510952|"     The purpose of this study is to examine the effectiveness and safety of insulin lispro     protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in     adults with type 2 diabetes.   "
203455|NCT00510718|"     This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to     treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional     patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients     who tolerate the drug and do not progress will be allowed to continue to look for PSA     response.   "
203456|NCT00510731|"     This is a prospective study to evaluating the ability of the PD2i Cardiac Analyzer to predict     the risk of serious heart rhythm abnormalities in high-risk patients that do not already have     an Implantable Cardioverter Defibrillator.   "
203457|NCT00510744|"     Hypothesis: Bypass of the upper GI tract with bariatric surgery results in suppression of     pancreatic function resulting in maldigestion and further malabsorption. In this study we     will measure pancreatic secretion in previously obese gastric bypass patients with excessive     weight loss. If malabsorption is associated with diminished pancreatic secretion, we will     test over a 3 month period whether supplementation with enzyme supplements prevent further     weight loss.   "
203458|NCT00510757|"     This study is designed to collect normative data on cervical isometric strength and range of     motion to supplement an existing normative data base.   "
203459|NCT00510770|"     The purpose of this study is to determine the effectiveness of continuous positive airway     pressure compared to standard treatment in preventing the need for intubation and mechanical     ventilation in patients who develop acute hypoxemia after liver transplant.      Hypoxemia complicates the recovery of 30-50 % of patients after abdominal surgery;     endotracheal intubation and mechanical ventilation may be required in 8-10 % of cases     increasing morbidity and mortality and prolonging intensive care unit and hospital stay.   "
203461|NCT00510796|"     Primary Objectives:      To test the feasibility of combined colon and endometrial cancer screening in women with     increased risk for colon and endometrial cancer.      To measure patient satisfaction for the combined procedure.   "
203462|NCT00510809|"     To determine the effects of policosanol on the cholesterol profile.   "
203513|NCT00511472|"     A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type     2 diabetics being treated with basal insulin.   "
203465|NCT00510848|"     Patients suffering from a rupture of the anterior cruciate ligament (ACL) with instability of     the knee joint are treated with an operative ACL-reconstruction: one group of patients with a     reconstruction with an autograft tendon (hamstrings), the other group with a reconstruction     with an allograft tendon (tibialis posterior). The same surgical technique, the same fixation     technique and the same rehabilitation protocol will be used in both groups. Follow-up will be     done during 2 years.   "
203466|NCT00510861|"     In the recent years, there is an increasing tendency to the parenthood delay in developed     countries, and there is not enough information available regarding the influence of the     male's age on fertility. If any, the negative impact should be acting at advanced ages.      Our aim with this work was to determine the role of paternal age on IUI results embryo     quality and IVF outcome. Evenmore, in order to standardize the female factor, good quality     oocytes (from fertile oocyte donors) and only first IVF cycles in young women were     considered.   "
203467|NCT00510874|"     The purpose of this study is to evaluate the safety and immune response of two-doses of GSK     Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
203468|NCT00510887|"     The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib     (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients     with follicular cell lymphoma.   "
203469|NCT00510900|"     The proposed work seeks to further understand the effects of LAA occlusion on cardiac     structure and function, and in homeostasis.      Numerous studies have implicated the left atrial appendage (LAA) as the source of the vast     majority of left atrial thrombi in the setting of AF3.      The University of Pittsburgh Medical Center will be implanting a Left Atrial Appendage filter     system (the WATCHMAN® Left Atrial Appendage Filter System, manufactured by Atritech, Inc.).     We aim to follow these patients for six months post implant in order to assess their heart     rhythm, function, and to do blood tests to evaluate for neurohormonal changes.   "
203470|NCT00510913|"     A study to compare the conversion to Prograf® (tacrolimus) to the continuation of     cyclosporine in patients at risk for chronic renal allograft failure   "
203471|NCT00510926|"     Results in CP are better in patients treated early after the onset of the disease with     respect to late CP . To date, the early McR rate to imatinib is clearly higher in low and     intermediate risk versus high risk (88 and 84% versus 65%). High dose of imatinib, as shown     in phase I-III trials may offer the possibility to increase the response rate of patients     belonging to this risk category.   "
203472|NCT00510939|"     This is one of the first studies of combination of Zarnestra plus Velcade in man. A primary     objective of the study is therefore to assess the safety and tolerability of multiple doses     of Zarnestra plus Velcade in patients with AML.      New treatments for patients that are untreatable with intensive chemotherapy aged de novo AML     patients or post-relapse AML are urgently required since, at present, many of the drugs used     for second line therapy are the same as those used for first induction and response rates are     much lower.        -  The following evidence suggests that Velcade plus Zarnestra can be an attractive          therapeutic combination for: AML patients.        -  Affymetrix gene profiling data showed expression of NFkB1 in all of 5 myeloid cell lines          cell lines tested and 35% of over 250 patient samples ( data generated in collaboration          with Sergio Ferrari and Pier Paolo Piccaluga unpublished results, our Institute and          University of Modena,Italy)        -  Preclinical evidence showed that AML cells in suspension culture were prevented to          develop de novo drug resistance and mediated drug resistance.      In Part B additional patients with AML will be treated to further characterize the     tolerability,biological effects, and clinical efficacy of the combination Velcade plus     Zarnestra. Patients on treatment for AML will undergo regular bone marrow aspirates and     biopsies to assess responses to treatment. This will facilitate frequent assessment of     biological endpoints (reduction in expression and phosphorylation of IKKb kinase, and     downstream markers of signalling along with apoptosis, survival, proliferation and cellular     size and ploidy) will be made in an attempt to confirm that the desired biological activity     has been achieved at the maximum tolerated dose.   "
203474|NCT00510965|"     The purpose of the study is to investigate the efficacy of a new drug called ranibizumab in     the treatment of choroidal neovascularization in underlying angioid streaks due to     Pseudoxanthoma elasticum. 10 patients will receive monthly injections of the drug in one eye     over a period of one year.   "
203475|NCT00510978|"     All of us have millions of bacteria living in our gut. These bacteria are very important to     our health providing us with protection against infections of the gut, allowing us to gain     extra nutritional value from food we eat and helping our immune system. Changes in the     balance of these many bacteria can make us vulnerable to infections both from within and from     outside the gut. Certain bacteria may also be directly associated with some diseases of the     gut. Research by doctors and scientists into relationships between the bacteria normally     found in our gut and certain diseases of the gut is helping to develop food supplements and     other therapies to treat these diseases.      This study involves research into the usefulness and safety of two probiotic products in     maintaining remission in Crohn's disease and ulcerative colitis. Approximately 360 patients     with Crohn's disease and ulcerative colitis from Ireland, Finland and Spain will be involved     in the study. The yoghurts used in this study contain either Lactobacillus salivarius subsp.     salivarius or Bifidobacterium infantis.   "
203476|NCT00510991|"     The aim of this study is to compare the efficacy of noninvasive positive pressure ventilation     versus best medical therapy in patients with acute severe asthma   "
203514|NCT00511485|"     This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in     participants with progressive adenocarcinoma of the lung.   "
203517|NCT00511524|"     GW842166X is being developed for the treatment and management of inflammatory pain. GW842166X     is a CB2 receptor agonist and the mechanism is not fully understood, although it is thought     that for the anti-inflammatory action the drug is required to cross inot the brain from the     blood. This study aims to look at if the drug crosses into the brain once given orally using     an imaging technique called positron emission tomography.   "
203477|NCT00511004|"     This study is conducted in Kerala, India. It will determine whether a new treatment regimen     of albendazole and diethylcarbamazine (DEC) for lymphatic filariasis can eliminate the     disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection     with very small parasitic worms that are spread by mosquitoes. The disease can cause swelling     of the arms, legs, breast and scrotum and can progress to permanent swelling of the legs or     arms called elephantiasis. The study will see if a higher and more frequent dose of     albendazole is better at clearing filarial worms from the blood than the current treatment.      Healthy people between 18 and 55 years of age who are in good health and who are infected     with filarial worms may be eligible for this study.      Participants undergo the following procedures:      3-day hospital stay at the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital     in Kerala, India        -  Random assignment to receive either: 400 mg albendazole and DEC 300 mg given once a year          for 2 years (standard treatment); or 800 mg albendazole and DEC 300 mg given once a year          for 2 years; or 800 mg albendazole and DEC 300 mg given twice a year for 2 years.        -  Urine pregnancy test for women of childbearing age .        -  Ultrasound test to look for filarial worms.        -  Treatment dose.        -  Monitoring for symptoms           6-month 3-day hospital stay        -  Medical history, physical examination and blood test.        -  Repeat ultrasound in subjects whose first ultrasound detected adult worms.        -  Treatment dose for subjects receiving medicine every 6 months.        -  Urine pregnancy test for women of childbearing age.           1-year 3-day hospital stay        -  Medical history, physical examination and blood test.        -  Treatment dose.        -  Repeat ultrasound in subjects whose first ultrasound detected adult worms.        -  Urine pregnancy test for women of childbearing age.           18-month 3-day hospital stay        -  Medical history, physical examination and blood test.        -  Treatment dose for subjects receiving medicine every 6 months.        -  Urine pregnancy test for women of childbearing age.           24-month 3-day hospital stay        -  Medical history, physical examination and blood test.        -  Treatment dose.        -  Repeat ultrasound in subjects whose first ultrasound detected adult worms.        -  Urine pregnancy test for women of childbearing age.   "
203478|NCT00511017|"     The goal of this clinical research study is to find the highest tolerable dose of     doxercalciferol that can be given to pediatric patients with relapsed solid tumors. The     safety of this drug will also be studied. Another goal is to measure the effect of the study     drug on the blood levels of calcium and vitamin D.   "
203479|NCT00511030|"     The purpose of this study is to determine the stability of capillary HBA1c blood samples     collected by the participant with this kit and mailed to the laboratory at Children's Mercy     Hospital.   "
203480|NCT00511043|"     This is a phase II open label study to assess the efficacy and safety of PTK787/ZK222584 in     adults with relapsed or refractory diffuse large cell lymphoma (DLCL). All subjects will     receive PTK787/ZK222584. Subjects who tolerate the study target dose of 1250mg will remain on     that dose until study completion at 12 months or until disease progression, unacceptable     toxicity, withdrawal of consent or non-compliance with the protocol requirement.   "
203481|NCT00511056|"     Study Hypothesis: Do certain risk behaviours impact/predict levels of HIV antiretroviral     adherence?      Objectives:        -  To assess risk behavior in HIV-positive individuals receiving highly active          antiretroviral therapy.(HAART)        -  To assess levels of adherence in the same subjects at the same time point        -  To determine if there is a correlation between HAART adherence and risk behaviour   "
203482|NCT00511069|"     Ph+ leukemias (i.e.Chronic Myelogenous Leukemia (CML) and (Ph+) Acute Lymphoblastic Leukemia     are malignant clonal disorder of the hemopoietic stem cell due to reciprocal translocation of     genetic material between chromosome 9 and 22 giving rise to the translocation t(9;22) (q2.2;     q2.1). The translocation causes the formation of a new hybrid gene (bcr-abl) that codes for a     185 kb or 210 kb cytoplasmic protein (P185 and P210 respectively) that by autophosphorylation     activates a number of signaling pathways involved in cell proliferation, maturation,     apoptosis and adhesion, leading to the malignant cell transformation1-3. The course of the     disease goes on through a chronic phase (CP), usually lasting some years, that is     characterized by a massive myeloid hyperplasia with hyperleukocytosis and splenomegaly. The     CP is almost always followed by an accelerated or blastic phase (ABP) where the leukemic     process acquires the characteristics of acute leukemia. The ABP usually lasts some months and     terminates with the death of the patient3.      The frequency of CML in western countries ranges between 10 and 15 per million persons (age -     standardized). It is rare in children. The median age is 55 years.      Current treatment of CML includes conventional chemotherapy, allogeneic bone marrow     transplantation (allo BMT), alpha-interferon (alpha-IFN)and imatinib.   "
203483|NCT00511082|"     -  To investigate the safety and tolerability of OPB-31121 following repeated oral          administration of OPB-31121 in patients Non-Hodgkin's Lymphoma(NHL) or Multiple          Myeloma(MM)        -  To determine the potential dose-limiting toxicities and maximum-tolerated dose in          patients treated with OPB-31121        -  To determine the pharmacokinetics and anti-tumor efficacy of OPB-31121 in patients   "
203484|NCT00511095|"     The purpose of this study is to further evaluate the safety and seroprotective immune     response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects     11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.   "
203485|NCT00511108|"     A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin     alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who     have inadequate glycemic (blood sugar) control.   "
203486|NCT00511121|"     This is a phase II multicenter, open-label study designed to investigate the feasibility     (tolerance, compliance and safety) of a combination of the tyrosine kinase inhibitor STI 571     (GLIVEC, Novartis Pharma) with a pegylated *-Interferon 2b (PEG INTRON). The rationale for     testing this combination is that 1) aIFN is curently the first line agent for the treatment     of CML, 2) the pegylated formulation of aIFN is more convenient and is better tolerated than     the conventional formulation, 3) STI571 is currently the most promising investigational agent     for the treatment of CML because it is targeted to the molecular bases of the disease, is     effective also in the advanced phases of the disease, and is effective also in the cases who     are resistant to aIFN, 4) the mechanisms of action of the two agents are different. Therefore     the combination of STI571 and PEGINTRON is likely to provide the best treatment of CML and to     be tested very soon in randomized phase III studies of efficacy. So far STI571 and PEGINTRON     have been investigated separately. The present study is an exploratory study that has been     planned with the aim of evaluating the adverse events and the safety of the combination, so     as to identify a safe and tolerable regime that can be tested prospectively for efficacy in a     subsequent, randomized phase III study. Based on available knowledge and data, STI571 is more     specific and can be more effective than PEGINTRON. Therefore in this exploratory study STI571     is given a priority over PEGINTRON as to dose and dose adaptation. Sixty subjects with     chronic phase CML, previously untreated with any one of study drugs, will be enrolled over a     3 months period and will be treated and studied for 12 months. The patients can be pretreated     with hydroxyurea , whenever required, hence are treated with STI 571 at a fixed dose (400mg)     and with PEG-Intron at doses ranging from 50 to 150 *g weekly (the first cohort of 20     patients at 50 *g/w, the second cohort of 20 patients at 100 *g/w and the third cohort of 20     patients at 150 *g/w). The response (hematologic, cytogenetic and molecular) to the     combination treatment will be evaluated every 3 months, and the pharmacokinetics of study     drugs will be studied in a sample of study patients. The duration of the study is 12 months,     for a total trial time of 15 months.   "
203515|NCT00511498|"     The ability of sildenafil to aid in the return of erections after nerve-sparing radical     prostatectomy has been established. Patients who had either one or both neurovascular bundles     spared demonstrated dramatically better responses to as needed sildenafil than those that     did not, and a positive erectile response to sildenafil was only seen in patients in whom at     least one NVB was spared. This study has been designed to determine if sildenafil taken     nightly works better than sildenafil on as as needed basis for the return of erectile     function. The investigators hypothesis is that sildenafil taken nightly promotes a more rapid     return of erectile function after nerve-sparing laparoscopic radical prostatectomy.   "
203487|NCT00511134|"     Objectives:      The primary objective of this study is to determine the efficacy of eszopiclone at treating     sleep problems related to withdrawal from nicotine in healthy smokers attempting smoking     cessation.      Sleep disturbances are a significant problem for smokers who are trying to quit smoking.     Smokers may be more likely to have sleep problems and both nicotine withdrawal and agents     used to aid smoking cessation (e.g., pharmacotherapies) may disrupt sleep. Lunesta     (eszopiclone) is a medication that has been approved by the FDA to treat insomnia.     Eszopiclone's efficacy for treating insomnia makes it a promising agent for treating nicotine     withdrawal-related symptoms of sleep disturbance.      This study will be 7 weeks duration. All participants will begin taking Zyban at the     beginning of week 1 and will be asked to try to quit smoking at the beginning of week 2.     Participants will also begin to take Lunesta or matched placebo (3 mg qd x 6 weeks) on the     target quit date at the beginning of week 2. All subjects will receive eight (8) weekly     sessions of brief individual supportive smoking cessation counseling.      Hypothesis:      It is hypothesized that significantly fewer sleep problems will be reported by participants     taking Lunesta as compared to placebo. Specifically, it is expected that participants taking     Lunesta will report less difficulty falling and staying asleep, higher sleep quality, and     less insomnia-related fatigue and distress than participants taking placebo.   "
203488|NCT00511147|"     Idiopathic (immune) thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by     platelet destruction and thrombocytopenia (peripheral blood platelet count < 150 x 10^9/L).     IVIG therapy is useful in patients in whom the platelet count has to be raised either due to     bleeding signs, or where bleeding is predicted (e.g., surgery or parturition). The primary     goal of treatment is to maintain the platelet count at a hemostatic level. This study will     test the safety and efficacy of IGIV3I Grifols 10% in the treatment of patients with chronic     ITP.   "
203489|NCT00511160|"     Myocarditis is mainly caused by cardiotropic viruses. In recent time viruses found in     endomyocardial biopsies mainly consist of parvovirus B19 (PVB19) and human herpesvirus 6     (HHV6). A definite causal link between virus-genome detection of PVB19 and/or HHV6 (via pcr     techniques)and cardiac inflammation and dysfunction is however still missing.      Primary objective:      To determine the prevalence of PVB19 and HHV6 virus genome in heart muscle biopsies of     cardiac surgery patients without clinical evidence of myocarditis or myocarditic sequelae      Secondary objectives:        1. Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance,          ecg, history, inflammatory markers) with biopsy results        2. Prognostic value of virus prevalence for the postoperative course      Primary hypothesis:      Patients without clinical evidence of myocarditis or myocarditic sequelae demonstrate to a     significant lesser extent inflammatory activity and virus genome in their myocardium as     compared to patients being clinical suspicious for myocarditis.   "
203490|NCT00511173|"     This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in     diagnosed patients requiring warfarin therapy.   "
203491|NCT00511186|"     The purpose of this study is to investigate the safety and tolerability of AP in sepsis     patients with renal failure and to investigate the effect of AP on inflammatory and clinical     parameters in sepsis patients with renal failure.   "
203492|NCT00511199|"     The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding     patterns (cycle control), general safety and acceptability of the nomegestrol     acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged     18-50 years.   "
203493|NCT00511212|"     The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy     with antibacterial agents for severe peritonitis after lower digestive tract surgery.   "
203494|NCT00511225|"     Will oral vitamin improve strength, bone quality, pain and quality of life. This is a double     blind, randomized placebo controlled study using 10,000 IU of cholecalciferol vs placebo.   "
203495|NCT00511238|"     To evaluate the overall response rate and safety and tolerability of carfilzomib in subjects     with relapsed and refractory multiple myeloma.      Patients must have received prior treatment with bortezomib and either thalidomide or     lenalidomide and be refractory to their last treatment.   "
203496|NCT00511251|"     Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung     samples first in induced sputum in correlation to disease second by comparing hazardous     particles in induced sputum to the analysis in lung tissue and finally by assessing if the     particles present in transplanted patients correlated with occupational history.   "
203497|NCT00511264|"     Laparoscopic Ultrasound (LUS) is an important part of the pre-treatment evaluation of     patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver     cancer). When a suspect lesion is visualized during LUS a biopsy should be provided in order     to differentiate between benign and malignant lesions. A new system for LUS guided biopsy has     been developed, but how often these biopsies are clinically relevant (i.e. changing patient     management)and how reliable are these biopsies are unknown.      The study hypothesis is that LUS guided biopsies are accurate and clinically relevant in the     pre-treatment evaluation of patients with upper gastrointestinal tract cancer.   "
203498|NCT00511277|"     The purpose of this study is:      To investigate whether a treatment with quetiapine for six months in patients with     first-episode psychosis may be effective in treating depressive symptoms.      To investigate whether a treatment with quetiapine for six months in patients with     first-episode psychosis may be effective in mania-like symptoms and to evaluate the general     efficacy in psychopathology as well as the safety and tolerability of quetiapine.   "
203499|NCT00511290|"     In the present study inflammatory mediators will be isolated in induced sputum and exhaled     breath condensate and will be correlated with particulate matter measured in these     samples.Particulate matter will be assessed by partcle size distribution method and shape     analysis.      The aim of the study is to perform biological monitoring in environmental and occupational     diseases in a non invassive fashion.   "
203516|NCT00511511|"     The aim of the study is to find simple clinical and laboratory parameters to predict the     development of hypertension and to elucidate the mechanism of hypertension during treatment     with the tyrosine kinase inhibitor Sunitinib.   "
203500|NCT00511303|"     This is a Phase II, open-label, multi-center trial designed primarily to evaluate the rate of     complete or major cytogenetic response of STI571 as demonstrated by a decrease in the     percentage of Ph chromosome positive cells in the bone marrow, in patients with CML who are     refractory to or intolerant of interferon-alpha.      During the core phase of the study, patients will receive once daily oral administration of     STI571 at a dose of 400 mg, for up to 12 months. After completing 12 months of therapy     patients may be eligible to receive additional therapy provided that, in the opinion of the     investigator, the patient has benefited from treatment with STI571 and in the absence of     safety concerns. Patients will receive STI571 on an outpatient basis.      During the extended phase (which is of indefinite duration), patients may continue STI571     until either progression to accelerated phase, blast phase, death, the development of     intolerable toxicity, or the investigator feels it is no longer in the patient's best     interest to continue therapy, whichever comes first. The number of visits will be at a     reduced frequency. Patients who discontinue study drug will be followed for survival for up     to 5 years.      STI571 will be considered active if the interferon-refractory patient population satisfies     the target of achieving a complete or major response at a rate of at least 30%, within the     preset error limits. Cytogenetic responses will be evaluated every three months and     categorized as either complete (0% Ph+ chromosome cells), or major (1 to 35% Ph+ chromosome     cells) responses. STI571 will be discontinued for any patient whose disease progresses to     either the accelerated phase or blast crisis.      A minimum of 100 patients who are interferon refractory will receive STI571 administered at a     dose of 400 mg once a day. In addition, the protocol is also open for patients who are     intolerant to interferon-alpha in order to get a preliminary evaluation of their response to     STI571 therapy. Up to 100 intolerant patients will be enrolled. Enrollment of intolerant     patients will cease at 100, or whenever the 100 refractory patients are accrued, whichever     comes first.   "
203501|NCT00511316|"     Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of     dysphagia and food impaction in patients with EE.      Also evaluate tolerance and safety of oral montelukast in treatment of EE.   "
203502|NCT00511329|"     The investigators hypothesize that the anabolic effects of Genotropin (somatropin) will     improve the height and weight of children with inflammatory based chronic illness who have     failed to grow despite receiving adequate nutrition. The investigators will test the     hypothesis by treating 32 chronically ill children (16 JRA and 16 Crohn's) with growth     hormone (GH) for 12 months and comparing them to baseline.   "
203503|NCT00511342|"     The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral     contraceptive (COC) on bone mineral density (BMD).   "
203504|NCT00511355|"     The primary purpose of this study is to evaluate the effects of the combined oral     contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal     function, and thyroid function.   "
203505|NCT00511368|"     The purpose of this study is to evaluate antiretroviral activity of up to five different oral     doses administered for two weeks of bevirimat versus placebo in HIV treatment experienced     patients, who have documented genotypic resistance to at least one major mutation from the     IAS-USA list (2007)of resistance mutations for NRTIs, NNRTIs, or PIs. Patients will also be     monitored for side effects, and the pharmacokinetics of bevirimat will be determined.   "
203506|NCT00511381|"     Two major limitations of existing audiometric newborn hearing screening programs are their     inability to detect forms of deafness that are not expressed at birth and the low compliance     with obtaining recommended audiologic confirmation and/or follow-up. Molecular genetic tests     on blood spots from all newborns will identify those at risk for the most frequent causes of     late-onset hearing loss and to add these infants to the group who should receive continued     audiologic monitoring.   "
203507|NCT00511394|"     Cirrhosis is frequently complicated by derangement of body fluid homeostasis resulting in     accumulation of large amounts of extracellular fluid in the peritoneal cavity (ascites) and     interstitial tissue (edema). Studies showed that patients with cirrhosis and ascites have     marked circulatory dysfunction. Albumin infusions have been used for many years in the     management of patients with cirrhosis and ascites in an attempt to reduce the formation of     ascites and/or improve circulatory and renal function. While some of these indications for     albumin infusions are supported by the results of randomised studies, others are based on     clinical experience and have not been proved in prospective investigations. Therefore, the     use of albumin infusions in patients with cirrhosis is controversial. Recently, this debate     has been fostered by the high cost and limited availability of albumin and the results of a     meta-analysis showing that albumin administration may increase mortality in critically ill     patients. In cirrhotics, there is a significant improvement in the low effective arterial     blood volume, which may be important in the prevention of circulatory dysfunction and in     preventing renal impairment. However, in an already fluid overload state such as that of     cirrhosis, albumin infusion predisposes the individual to develop pulmonary edema. There is     no study demonstrating acute effect of albumin infusion on hemodynamic parameters, in     cirrhotic patients. Neither is there is data concerning comparison between albumin and normal     saline. It is postulated that it may increase portal pressure thereby increasing the risk of     variceal bleed. This study hypothesizes that albumin infusion might lead to alteration in     portal and pulmonary hemodynamics in decompensated cirrhotic patients. Included patients of     cirrhosis with ascites (based on inclusion and exclusion criteria) will undergo baseline     investigations (systemic hemodynamics, pulmonary hemodynamics, portal hemodynamics). They     will be randomized into two groups, each of 8. One group will receive infusion of 100 ml 20%     albumin over 3 hours, and the other will receive infusion of 100 ml normal saline over 3     hours. Repeat hemodynamic studies will be performed after the infusion finishes. All results     will be expressed as mean ± SD or frequency (%). Comparisons will be performed by the     Student's t test or with the Wilcoxon's test   "
203526|NCT00511641|"     The goal of this research study is to learn more about how women feel about an ovarian cancer     screening program that involves getting a blood test to measure CA 125 levels. This includes     finding out about women's quality of life and whether they are concerned or worried about     their risk of developing cancer. This study also seeks to find out whether elevated CA 125     levels affect participants in terms of cancer worries or concerns.   "
203508|NCT00511407|"     Although conventional hemodialysis removes waste products and corrects fluid imbalance, it     does not replace critical absorptive, metabolic, endocrine, and immunologic functions     performed by healthy renal tubule cells. This trial involving patients with acute renal     failure evaluates the efficacy and safety of an extracorporeal renal assist device (RAD)     containing human renal tubule cells connected to a conventional hemodialysis circuit. It is     hypothesized that short-term (72-h) use of this cell therapeutic device will improve survival     of ARF patients compared to patients receiving only conventional continuous renal replacement     therapy.   "
203509|NCT00511420|"     The purpose of this study is to evaluate the effects of optimized composition chocolates that     include natural ingredients with demonstrated biological activity are observed     cardioprotectores effects in the human.   "
203510|NCT00511433|"     The primary purpose of this study is to evaluate the effects of the nomegestrol     acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.   "
203511|NCT00511446|"     Combination regimens of 3 active drugs have shown promising activity in treatment of     metastatic gastric cancer. Docetaxel combined with cisplatin and 5-fluorouracil (FU) yielded     superior overall survival and response rates when compared to standard cisplatin and 5-FU.     However, a toxicity profile showed the need for development of less toxic modifications. In a     prior phase I trial, the maximum tolerated dose was defined. In this phase II trial, a first     evaluation of activity will be performed.   "
203512|NCT00511459|"     This is a phase 2, randomized, placebo controlled, multi-center study to estimate the     treatment effect and evaluate the safety and tolerability of AMG 386 in combination with     paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative     metastatic or locally recurrent breast cancer.      AMG 386 is a man-made medication that is designed to stop the development of blood vessels in     cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called     angiogenesis, to obtain a supply of oxygen and nutrients to grow.   "
203518|NCT00511537|"     This study performs HLA matched stem cell transplantation from unrelated donors in adults who     require stem cell transplantation but do not have a matched related donor available. The     incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded.     This study also monitors the activity and toxicity of total body irradiation and     cyclosphosphamide followed by stem cell transplantation from matched unrelated donors.   "
203519|NCT00511550|"     Peripheral blood stem cells (PBSCs) collected following stimulation with filgrastim are     commonly used for autologous hematopoietic transplants. PBSCs are also now being used for     some syngeneic and allogeneic hematopoietic transplants involving HLA-matched sibling donors.     However, many issues remain unanswered about the use of PBSCs for allogeneic transplants and     the effects of filgrastim on healthy individuals. The purpose of this study is to determine     the effectiveness of filgrastim stimulated PBSCs in hematopoietic cell transplants involving     unrelated donors and to determine the effects of this donation process on unrelated stem cell     donors.   "
203520|NCT00511563|"     To better understand the way that GW876008 and GSK561679 work on hormone responses in     patients with Irritable Bowel Syndrome.   "
203521|NCT00511576|"     The purpose of this study is to test the combination of an experimental drug known as     MGCD0103 given along with an FDA-approved drug called docetaxel. This is a Phase 1 study that     will look at different doses of MGCD0103 given along with docetaxel in order to better     understand the effects (positive and negative) of this combination on the subject's body and     disease.      The study would like to find the following information:        -  How long MGCD0103 and docetaxel stay in the subject's body;        -  What effects, good and/or bad, MGCD0103 and docetaxel have on the subject and on his/her          cancer; and        -  If the genetic and chemical make-up of the subject's blood cells and tumor cells play a          role in how you respond or do not respond to MGCD0103 and docetaxel.   "
203522|NCT00511589|"     T. cruzi infection affects approximately five million people in Brazil. The diagnosis of the     chronic phase of infection is performed by indirect serological methods which, nevertheless,     leave inconclusive results. One of the direct methods used for T. cruzi identification, blood     culture in LIT (liver infusion tryptose) medium, presents low sensitivity in that phase of     the disease. A negative result does not eliminate the possibility of infection, but a     positive test has high absolute diagnostic value, which enables the indication of     antiparasitic treatment. Molecular diagnosis (PCR) in this phase is promising and can be used     as a confirmatory test, particularly when individuals present inconclusive results in     conventional serological tests, such as ELISA, HAI and IFI. This study aimed at improving     blood culture sensitivity in LIT medium by performing PCR in individuals with positive and     inconclusive serology for chagasic infection.   "
203523|NCT00511602|"     Primary objective to evaluate the effect of a 12-week treatment period with prandial     administration of Technosphere Insulin on glucose control in subjects with T2 DM. Secondary     objective is to Evaluate the safety and tolerability of a 12-week treatment period of     Technosphere Insulin and Technosphere Placebo.   "
203524|NCT00511615|"     The hypothesis of this research project is that topical application of the anti-EGFR or     anti-E6/E7 contrast agents followed by optical imaging will yield images that reflect spatial     variations in expression that correlate with the presence of cervical precancer. To gather     feasibility data the investigators will:        1. Obtain cervical specimens from women with high grade squamous intraepithelial lesions          (HGSILs) being treated with the loop electrosurgical excision procedure (LEEP).        2. After Loop Electrosurgical Excision Procedure (LEEP) is performed, obtain low and high          resolution optical images before and after applying contrast agents topically to the          epithelial surface of the tissue for 30 minutes before rinsing.        3. Submit the specimen for histology, and have it sectioned and stained using both H&E and          immunohistochemical staining for EGFR or E6/E7. The images will be reconstructed into a          two dimensional map delineating areas of Cervical Intraepithelial Neoplasia (CIN) and of          EGFR or E6/E7 overexpression. Maps of the pathology will be compared to those obtained          from the intact cervix exposed to the contrast agent.   "
203525|NCT00511628|"     The purpose of this study is to evaluate the safety of risperidone treatment in patients who     are overweight and/or obese.   "
203646|NCT00512863|"     To evaluate the efficacy of SC injections of 3 regimens of adalimumab vs. placebo in the     change in post-bronchodilator FEV1 from Baseline to Week 16 when used in the treatment of     refractory asthma.   "
203527|NCT00511654|"     This study is being conducted to obtain information on the safety and tolerability of     repeated doses of GW823296 for 28 days in healthy male and female subjects. In addition, the     pharmacokinetics of GW823296 will be evaluated to confirm the doses to be used in Phase II     efficacy studies. The effect of repeat dose (RD) of GW823296 on CYP3A4 enzyme activity will     be investigated evaluating the pharmacokinetics of midazolam and urine     6-?-hydroxycortisol/cortisol ratio.   "
203528|NCT00511667|"     A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in     patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily     MK-0941 in subjects with T2DM with or without adequate control on metformin will be     sufficiently safe and well tolerated to permit continued clinical investigation.   "
203543|NCT00511862|"     This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere     treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with     metastatic disease to the liver that cannot be treated or is progressing following treatment     with systemic or other liver-directed therapies.   "
203544|NCT00511875|"     This 24 month randomized research study will evaluate whether doxycycline can 1) slow the     deterioration or improve retinal function and/or 2) induce regression, or slow progression,     of diabetic retinopathy in participants over 18 years of age with type 1 or type 2 diabetes     with severe non-proliferative or early proliferative diabetic retinopathy.   "
203573|NCT00512252|"     This study is a phase I/II study to determine the safety and efficacy of AMD3100 when     combined with mitoxantrone, etoposide, and cytarabine in patients with relapsed or refractory     AML.      We hypothesize that disrupting the interaction between AML blasts and the marrow     microenvironment with AMD3100 may enhance the cytotoxic effect of chemotherapy.   "
203529|NCT00511680|"     The specific primary aims of the study are to:        1. Test the immediate effect of the intervention at 4-months on depression in urban African          American older adults (primary trial outcome; between group comparison). Hypothesis:          Participants in the intervention group will report fewer depressive symptoms in          comparison to control group participants receiving usual care.        2. Test the maintenance effect of the intervention at 8-months on depression (within group          comparison). Hypothesis: Participants in the intervention group will maintain reduced          symptom presentation from 4 to 8 months.        3. Evaluate acceptability (social validity) of the intervention and extent of engagement in          activities by study participants (both intervention and wait-list control subjects).      A secondary aim of this study is to assess the feasibility of conducting a clinical trial     embedded in a community service setting and its dissemination using a community-academic     partnership. We also propose three exploratory aims. First, we seek to evaluate the     mechanisms of action, or pathways, by which treatment gains are obtained (Gitlin et al.,     2000). Given that behavioral activation represents conceptually the key active ingredient of     the proposed intervention, we plan to evaluate its mediational effect. Second, we seek to     evaluate whether the intervention has a differential treatment effect based on a study     participant's gender, age, and living arrangement (alone or with others). Given that previous     research suggests that participant characteristics may moderate depressive symptoms and     treatment outcomes, these exploratory analyses will provide insight as to whether this     particular treatment benefits some groups more than others. Third, we seek to evaluate     whether the intervention has short and long-term effects on quality of life, functional     difficulty, and self-efficacy to manage day-to-day tasks. Previous research has shown that     depressive symptoms exacerbate functional decline such that minimizing distress may have the     added value of enhancing function and perceived efficacy for this group over time.   "
203530|NCT00511693|"     A Regional Osteoporosis Coordinator located at Women's College Hospital will follow-up with     low trauma fracture patients from 30 smaller community hospitals across Ontario. To evaluate     whether this quality improvement program can increase post-fracture osteoporosis care in     these individuals, hospitals will be randomized to receive osteoporosis specific     recommendations or falls prevention advice. Patients will be asked to complete two short     telephone surveys about their recent fracture, risk factors, osteoporosis knowledge and     diagnostic and treatment history. All patients in the falls prevention advice group will     receive the osteoporosis specific recommendations 6 months after their fracture.   "
203531|NCT00511706|"     The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone     with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients     with subfoveal choroidal neovascularization secondary to age-related macular degeneration.   "
203532|NCT00511719|"     The purpose of this study is to compare the kinetics and biodynamics of inhaled Technosphere     Insulin with those of subcutaneous (SC) regular human insulin.   "
203533|NCT00511732|"     Designed to evaluate dose response of force-titrated prandial administration of TI as     compared to placebo (TP) in subjects with Type 2 diabetes who were suboptimally controlled   "
203534|NCT00511745|"     The purpose of this study is to evaluate the safety of rabeprazole 20mg/day in polymedicated     patients and to examine the necessity of adjusted dosage in both therapies (rabeprazole and     concomitant drug). Proton pump inhibitors (PPI) act in the final step of the gastric     secretion. PPI's block ATP-ase H+/K+ in gastric parietals cells. It has been described that     inhibition of acid secretion has produced the recovery of the gastroesophageal pathology in a     high percentage of the patients resistant to conventional drugs. In this context, the     objective of the study is to evaluate the safety of rabeprazole as a concomitant treatment     and examine the clinical practice the interaction with drugs whose absorption has gastric pH     dependence.   "
203535|NCT00511758|"     The overall objective of this study is to evaluate whether polarized or green filtered     digital imaging can assist clinicians to screen for premalignant lesions in the cervix.      The specific aims of the study are:        -  To compare polarized and green filtered digital images of the cervix, to standard white          light images, colposcopic evaluation and to pathologic analysis of biopsied tissue.        -  To develop algorithms to discriminate between normal and abnormal tissue based on          digital images of the cervix.        -  To analyze digital images to determine which types of optical information yield the most          diagnostically useful data.   "
203536|NCT00511771|"     To provide tegaserod to eligible women adult patients who did not have satisfactory     improvement of their irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic     constipation (CIC) symptoms with other available treatment(s) and / or patients who had     satisfactory improvement of their symptoms with prior tegaserod treatment for IBS-C or CIC.   "
203537|NCT00511784|"     This study uses the PharMetrics and MarketScan US health care insurance claims database to     estimate relative risks for non-fatal venous thromboembolism (including cerebral venous sinus     thrombosis), ischemic stroke, and acute myocardial infarction (heart attack), in current     users of ORTHO EVRA (norelgestromin and ethinyl estradiol contraceptive patch) compared to     current users of oral levonorgestrel-containing oral contraceptives with 30 micrograms     ethinyl estradiol, with special attention to duration of use.   "
203538|NCT00511797|"     The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.   "
203539|NCT00511810|"     The primary objective of the study was to determine the effects of 10-week adjunctive     supplementation with 2 doses of LCn-3 fatty acids (fish oil) on cortical functional activity     and biochemistry in adolescents with MDD.      The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently     increase prefrontal cortical functional activation during sustained attention and increase     regional biochemical indices of cortical metabolism and integrity concentrations in     association with reductions in depressive symptoms.   "
203540|NCT00511823|"     This A Three-Part Drug-Drug Interaction Study To Evaluate Effects of Casopitant On     Dolasetron, Granisetron or Rosiglitazone When Co-Administered in Healthy Adults   "
203541|NCT00511836|"     This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the     associated brain activation patterns in alcohol-dependent adults who had recently completed     alcohol detoxification and were seeking further treatment for their alcohol dependence. The     study was powered to to detect whether VIVITROL attenuates or blocks the BOLD signal     increases in response to alcohol-related cues.      In the double-blind portion, subjects received a single administration of study drug     (VIVITROL 380 mg or placebo). Subjects who completed the double-blind portion could opt to     continue to the open-label portion and receive 2 additional months of treatment with VIVITROL     380 mg.   "
203542|NCT00511849|"     The purpose of this study is to test SU011248 (sunitinib) in combination with     paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor     activity.   "
203561|NCT00512096|"     Primary Objective:      -To evaluate the feasibility and efficacy of multimodality treatment (neoadjuvant     chemotherapy prior to extirpative surgery) for clinical stage TXN2-3M0 squamous cell     carcinoma of the penis.   "
203545|NCT00511888|"     BACKGROUND Beta-blockers improve left ventricular (LV) systolic function and prognosis in     patients with chronic heart failure. Both carvedilol and nebivolol have hemodynamic and     clinical benefits in chronic heart failure (CHF), but it is unknown whether their pleiotropic     properties may play a role in different subgroups of patients with CHF.      OBJECTIVE: To compare the effects of nebivolol and carvedilol on LV function and clinical     outcome in patients with chronic heart failure and reduced LV systolic function.      METHODS: 160 hypertensive CHF patients, LV ejection fraction (EF) 40% and in New York Heart     Association (NYHA) functional class II or III were randomly assigned to receive carvedilol or     nebivolol therapy for 24 months. At baseline and after 24 months of treatment, all patients     underwent clinical evaluation: echocardiogram and 6-minute walking test.   "
203546|NCT00511901|"     Patients who are admitted to subacute rehabilitation facilities following hospitalization are     frequently anemic. The purpose of this study is to see if anemic patients treated with     epoetin alfa will have higher hemoglobin levels and better functional recovery at 3, 8, and     12 weeks after study entry compared to patients who do not receive epoetin alfa.   "
203547|NCT00511914|"     Annual trial for registration of sub-unit influenza vaccine produced in mammalian cell     culture, using the strain composition 2007/2008, when administered to adult and elderly     subjects   "
203548|NCT00511927|"     Aim of this study is to define the possible detrimental effect of a lack of growth hormone,     on the well-being and life expectation of patients affected by heart failure.   "
203549|NCT00511940|"     The purpose of this research study is to determine the efficacy (how well it works),     tolerability and safety of acomprosate compared with placebo in patients with binge eating     disorder.   "
203550|NCT00511953|"     Depomed's Gabapentin Extended Release is an investigational, extended release formulation of     gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.   "
203551|NCT00511966|"     The objective of this Observational study is to evaluate hygiene-dietetic habits as     co-adjuvant treatment of the pharmacologic therapy use to treat Gastroesophageal Reflux.   "
203552|NCT00511979|"     A prospective, single center, open randomized, six way crossover study comparing the dose     response effect of four different doses of Technosphere Insulin after pulmonary function     delivery in comparison to s.c. injection of two different doses of regular human insulin.   "
203553|NCT00511992|"     The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with     intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete     6 cycles of treatment.   "
203554|NCT00512005|"     The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate     safety and feasibility of the iCoapsys System in patients with functional mitral valve     insufficiency caused by annular dilation and/or papillary muscle displacement.   "
203555|NCT00512018|"     The purpose of this study was to assess the effects of Neuromuscular Electrical Stimulation     (NMES) associated to an isokinetic training program in both young healthy men and women.     Twenty subjects (10 men, 10 women; 21±1.5 years) submitted both quadriceps femoris muscles to     a strengthening program (3 sets of 10 isokinetic concentric repetitions at 30°/s) two days     per week for 4 weeks. One limb was submitted only to the strength training (EX) while the     other underwent the same training program but with NMES added to each contraction (Ex+NMES).     The current used for NMES was Russian Current (frequency of 2500 Hz, 50 bursts/s and pulse     duration of 200 µs). The evaluation protocol included isometric and isokinetic concentric     extensor torques at 30°/s. Men increased their torque in both tested modalities in both     limbs, with no difference between them. The angle of peak torque increased for the EX limb,     showing an altered tension-length relationship, which did not occur for the Ex+NMES limb or     for women. Women increased their torque for EX limb in both modalities, which only occured     for isometric mode in the Ex+NMES limb. However, they showed a decrease in their acceleration     time in Ex+NMES limbs, showing they could produce a muscular contraction more readily than     they did before training. The results of this study found that the association between NMES     and isokinetic concentric voluntary strength training does not improve strength gains of     voluntary training itself for young healthy subjects of both genders. However, it could     improve neuromuscular readiness to produce torque in women.   "
203556|NCT00512031|"     To determine how altering the expression of a gene known as PAI-1 may affect the adhesive     capacity of cells that play a critical role in the developement of human atherosclerosis.   "
203557|NCT00512044|"     The purpose of this study is to determine whether local or general anaesthesia in stapled     hemorrhoidectomy leads to a shorter operation time with a better patient comfort.   "
203558|NCT00512057|"     Morbidity of patients with cardiac syndrome X (typical anginal-like chest pain and normal     coronary arteriograms) is high with continuing episodes of chest pain and frequent hospital     readmissions. Management of this syndrome represents a major challenge to the treating     physician. Evidence for the important role of endothelial dysfunction and oxidative stress in     the pathogenesis of cardiac syndrome X has been recently strengthened by the finding that     basal superoxide production predicts future cardiovascular events in this patient group. The     investigators have recently shown that high-dose allopurinol abolishes vascular oxidative     stress and improves endothelial function in patients with chronic heart failure, which makes     allopurinol a prime candidate to reduce oxidative stress in syndrome X. The hypothesis to be     tested in this study is whether allopurinol offers dual benefits of improving vascular     function and reducing myocardial ischaemia in patients with cardiac syndrome X. This study     may discover a novel way to improve endothelial function and anginal symptoms which are often     debilitating in these patients.   "
203559|NCT00512070|"     Atypical antipsychotic medications, such as olanzapine, cause metabolic side effects,     including weight gain, extra fat around the middle of the body, high blood sugar, and high     cholesterol. One of the mechanisms by which these medications may cause these effects is by     reducing plasma melatonin. This study is a pilot project to evaluate 1) the effect of     olanzapine on melatonin secretion levels and 2) the effect of melatonin on olanzapine-induced     changes in melatonin secretion in patients with schizophrenia, schizoaffective, or bipolar     disorder.   "
203560|NCT00512083|"     The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of     doses, when combined with cytarabine, in the treatment of patients with primary refractory or     relapsed acute myeloid leukemia (AML).   "
203562|NCT00512109|"     The investigators' study has 4 primary objectives. Among patients undergoing noncardiac     surgery the investigators will determine: (1) the incidence of major perioperative vascular     events; (2) the optimal clinical model to predict major perioperative vascular events; (3)     the proportion of patients with perioperative myocardial infarctions that may go undetected     without perioperative troponin monitoring; and (4) the relationship between postoperative     troponin measurements and the 1 year risk of vascular death.   "
203563|NCT00512122|"     In critically ill patients, a strategy aimed at an early delivery of full caloric support,     with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions     preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less     morbidity as compared to a strategy using only EN.   "
203564|NCT00512135|"     The study objective was to investigate the safety and efficacy of incobotulinumtoxinA     (Xeomin) during repeat dose treatment of glabellar frown lines. 801 subjects with moderate to     severe glabellar frown lines at maximum frown who completed participation in one of the     studies in this program, i.e., MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or MRZ     60201-0741/1 were eligible to participate in this repeat-dose study.   "
203565|NCT00512148|"     Subjects with neurogenic bladder secondary to spinal cord injury that is refractory to     medical treatment and requires augmentation cystoplasty will be enrolled. The hypothesis is     that augmentation cystoplasty using an autologous neo-bladder construct will reduce maximum     detrusor pressure.   "
203566|NCT00512161|"     The purpose of this study is to determine the predictors for placement of permanent     pacemakers soon after cardiac surgery. We will measure the following to see what influence,     if any, they have on predicting the need for permanent pacemaker implantation.        1. Type of cardiac surgery        2. Gender of patient        3. Patient's age        4. Preoperative heart rhythm and rate        5. Duration on cardiopulmonary bypass        6. Immediate post cardiopulmonary bypass heart rhythm and rate.        7. All heart rhythms and rates identified in the postoperative period prior to permanent          pacemaker implantation.        8. Underlying heart rhythm and rates when permanent pacemaker is placed.        9. Ejection fraction before surgery       10. Ejection fraction immediately post-cardiopulmonary bypass   "
203567|NCT00512174|"     Thirty patients who underwent radical cystectomy and bladder substitution and thirty people     with native bladders will be enrolled in the study. After meticulous explanations each person     will undergo sterile catheterization of the bladder/neobladder with a 14 Fr Foley catheter.     After catheterization the bladder will be fully emptied. Randomly assigned volume of sterile     saline will be injected to the bladder via the catheter by one sub investigator and the     bladder capacity will be measured via a portable ultrasound scanner for non-invasive bladder     volume measurement (BladderScan BVI3000) by another sub investigator. The volume injected and     the measured results will remain in a closed envelope till the completion of the trial. After     each measurement the first sub investigator will completely empty the bladder/neobladder and     the process will repeat itself for a total of six measurements for each patient or first     mention of discomfort (whichever comes first), after which the bladder will be drained once     more and the catheter removed.   "
203568|NCT00512187|"     The study hypothesis is to investigate whether a moderate weight loss (i.e. a weight     reduction of at least 5%) could improve the response rate to a suboptimal dose of     cyclosporine in patients with severe psoriasis.   "
203569|NCT00512200|"     Geriatric patients have a high risk of developing postoperative cognitive deficits.     Hypothetical causes are insufficient intraoperative cerebral perfusion or drugs that are     administered in the perioperative setting. This study will investigate the role of these two     factors in patients aged 65 or older undergoing elective surgical procedures under general     aesthesia. Non-invasive techniques will be used to monitor intraoperative cerebral perfusion     and anticholinergic activity in the patient's blood is determined. Data will be compared to     those of a young (20-40 year old) group of patients undergoing elective surgical procedures     using an identical anesthetic technique. A second control group of healthy volunteers older     than 65 will be investigated to quantify practice effects with repeated testing of cognitive     functions.   "
203570|NCT00512213|"     The aim of this trial is to compare preoperative Imunnonutrition with standard enteral     nutrition regarding morbidity after major abdominal surgery in patients with NRS greater 3.      The primary end point is the complication rate until 30 days after surgery.   "
203647|NCT00512876|"     Purpose: To determine the efficacy and safety of one commonly used VEGF inhibitor,     bevacizumab (Avastin, Genentech), as a topical agent for the treatment of corneal     neovascularization.   "
203571|NCT00512226|"     Iron overload is well study in Thalassemia patients and it's not only related to blood     transfusions, since intestinal iron absorption is also increased in those patients. Sickle     cell patients didn't develope significant clinical symptoms and signs of iron overload in     spite frequent transfusions. The purpouse of this study is to assess the iron overload in     Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and cardiac     T2*MRI in order to determine the cardiac and liver iron.   "
203572|NCT00512239|"     Inflammatory joint diseases are major causes of invalidity and morbidity. Rheumatoid     arthritis (RA), the most frequent of chronic arthritides, affects close to 1% of the Canadian     population. Direct and indirect costs of RA represent close to 1% of the gross national     product. Recent evidence suggest that initiation of early (e.g., during the first 3-12 months     of disease) aggressive treatment decreases both mortality and long term invalidity in RA and     other chronic arthritides. However, a significant proportion of patients with early     polyarthritis (EPA) have a benign evolution, even if they fulfill criteria for RA. On the     contrary, most patients whose arthritis persist for more than 12 months have a progressive     and destructive disease. Currently available clinical, serological and genetic markers of     severity in arthritic patients perform poorly in EPA patients to identify those patients     whose arthritis is likely to persist and thus who deserve an aggressive treatment.      The Investigators propose a prospective and longitudinal study to define the contribution of     detection of rheumatoid arthritis-specific autoantibodies (RASA), either alone or in     combination with other markers of severity, in the prognostic evaluation of patients     presenting with EPA. Availability of such an effective serological tool to establish     prognosis in individual patients would improve therapeutic decisions in clinical practice.     The same prognostic tools would represent very powerful instruments to subset patients into     more homogeneous groups in clinical trials, increasing their power.   "
203616|NCT00506480|"     The purpose of this study is to determine whether endometrial receptivity markers obtained by     endometrial sampling are effective in prediction of in vivo human embryo implantation.   "
203574|NCT00512265|"     The purpose of this study is to evaluate the effect of high-dose n-acetylcysteine on     inflammatory reaction, pulmonary morbidity, oxygenation and quality of life in patients     undergoing transthoracic, partial or total resection of the esophagus for cancer.   "
203575|NCT00512278|"     The aim of the study is to investigate in subjects receiving their first course of     peg-interferon α-2b plus ribavirin therapy for chronic HCV infection (genotype 1) whether the     addition of infliximab to a standard regimen of pegylated interferon α-2b in combination with     ribavirin:        -  increases the proportion of subjects attaining a sustained virological response SVR          (undetectable blood Hepatitis C viral load 6 months after treatment)        -  improves the safety profile compared to the same regimen without infliximab   "
203576|NCT00512291|"     The objective of this study is to determine the tolerability and safety of olanzapine     administered as a subcutaneous injection to hospitalized patients with hyperactive or mixed     delirium.   "
203577|NCT00512304|"     Post-operative radio-chemotherapy decrease the recurrence risk of gastric cancer(N Engl J Med     2001). However the chemotherapy regimen (5 fluorouracil IV bolus) used was toxic and     suboptimal. We propose to evaluate in adjuvant situation an active and well tolerate     chemotherapy regimen (FOLFIRI)in patients with metastatic gastric cancer. During the     radiotherapy we will use 5 FU continue infusion as previously reported. The global design of     adjuvant treatment will be four FOLFIRI courses, radiotherapy (45 Gy)with 5FU IV continue     then four FOLFIRI.   "
203578|NCT00512317|"     To allow open-label extension to patients who have completed Protocol 1042-0600.   "
203579|NCT00512330|"     In children, it remains quite difficult even in developed countries, to prove a diagnosis of     Tuberculosis (TB). New means for diagnosis of this disease are currently being researched.     One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity of     up to 80% in adults.      Our study aims to evaluate this test in the diagnosis of children with TB.   "
203580|NCT00512343|"     The objectives of this group project is to collect synovial fluid (SF) and paired sera and     carry out preclinical studies to evaluate, alone or by combination testings, the potential of     novel biomarkers for their prevalence and diagnostic/prognostic values in patients with     arthritis, and to determine how therapeutic intervention regulate their levels.   "
203581|NCT00512356|"     The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP)     in preventing or reducing post-operative adhesion formation and re-formation in a subject     population having abdominal surgery and being left with a rectal stump and a temporary stoma     from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in     the normal treatment of the subjects' disease. In both study groups, surgical measures to     prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using     powder-free gloves. In the investigational product group, AAP was applied to the rectal stump     and the incision line while no specific additional treatment was applied in the control     group. The surgeon assessed preexisting adhesions during the first surgery. Newly developed     and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant     who did not know the result of randomization. The safety of the study drug was also     monitored.   "
203582|NCT00512369|"     Researching genetic differences in people with no prior medical conditions for better     understanding of cardiac diseases through genetic research.   "
203583|NCT00512382|"     GER and respiratory symptoms are both common phenomenon in children. Both can coexist in the     same patient by chance alone. Research reveals increased incidence for both to coexist     leading to suspect a temporal association and possible causality. Therefore we conducted an     observational study To determine the primary cause (RS or GER)using for the first time both     PH-Impedance as measurements of GER and Wheezy monitoring (WEEM) that records simultaneously     wheeze and cough noises. Both modalities will be recorded for 12-24 hours. If GER precedes     cough/wheeze recordings it points to GER being the possible precipitating factor and vice     versa.   "
203584|NCT00512395|"     Epidural anaesthesia in open surgery is a effective method for analgesia and has a positive     effect on postoperative resolution of ileus. In laparoscopic surgery, the role of epidural     surgery is not established. This prospective observational trial evaluates the effect of     epidural analgesia in patients undergoing elective, laparoscopic colorectal surgery.   "
203585|NCT00512408|"     Background: Patients with congestive heart failure (CHF) show muscle mass wasting and     decreased testosterone levels. Long-term testosterone supplementation improves walking     distance and glucose metabolism of patients CHF. No studies have investigated the integrated     effects of testosterone on exercise oxygen uptake muscle strength and glucose metabolism in     patients with CHF regardless of the presence of hypogonadism.      Aim: To assess the effect of a 12 week testosterone administration on maximal exercise     capacity, muscle strength and insulin resistance in elderly CHF patients.      Methods: Seventy elderly patients with stable CHF, mean age 71 ± 8 years, ejection fraction     34 ± 1%, NYHA class II/III 38/32, were enrolled. Of these, 35 were randomized to receive     testosterone therapy (through intramuscular injection every 6 week) and 35 to receive placebo     both on top of maximal medical therapy. At baseline and after 12 weeks all patients underwent     echocardiogram, cardiopulmonary test, 6-minute walking test (6MWT), quadriceps maximal     isometric and isokinetic strength.   "
203586|NCT00512421|"     The use of computer-assisted surgery by orthopedic surgeons experienced in the performance of     total knee arthroplasty may result in better overall limb and implant alignment and fewer     outliers as compared with the findings after manual total knee arthroplasty.      The alignment results in previous studies were based on radiographic measurements. The     sensitivity of radiographic assessment of limb and implant alignment may not be significant     enough to distinguish small differences between computer-assisted surgery and manual     techniques.      It is possible that alignment differences that were too minor to be exposed on standard     radiographs might result in long-term differences in the durability of arthroplasties     performed with use of computer-assisted surgery or manual techniques.      Moreover it is possible to measure additional implant positioning parameters with computed     tomography (CT) technology.      In this study, the investigators would like to add new method, for accurate measurement of     implant alignment and to correlate its results with clinical data.   "
203587|NCT00512434|"     The treatment of open tibial shaft fracture is often complicated by delayed union or     non-union. The objective of this study is to evaluate the efficacy of autologous concentrated     bone-marrow to accelerate healing of open tibial shaft fractures and to reduce the need for     secondary intervention.      In a prospective, randomized, controlled, single-blind study, 186 patients with an open     tibial will be randomized to receive either the standard of care (fixation by nail or     external fixator and routine soft-tissue management), or the standard of care with     percutaneous injection, one month after fracture, of autologous concentrated bone-marrow.     Randomization will be stratified by severity of the open wound. The primary outcome measure     will be the proportion of patients requiring secondary intervention because of delayed union     or nonunion within twelve months post-fracture.   "
203588|NCT00512447|"     New technology allows non-invasive monitoring of brain oxygenation     (Near-Infrared-Spectroscopy). However, there are no large series of normal values in various     adult age groups. We hypothesised that baseline values in patients breathing room air are     lower in old patients than in younger subjects and that younger patients respond increase     their brain oxygenation more in response to supplemental oxygen.   "
203589|NCT00512460|"     1. The primary objectives of this study are:             1. To determine the tolerability of RTA 744 Injection in patients with leptomeningeal               disease (LMD) secondary to any type of primary tumor.             2. In a selected group of 6-10 patients who will receive RTA 744 at or near the               maximum tolerated dose (MTD), to characterize the multiple-dose pharmacokinetics of               RTA 744 in plasma and CSF.        2. The secondary objectives of this study are:             1. To document any potential antitumor activity of RTA 744 in this patient population.             2. To correlate pharmacokinetic information with clinical (efficacy and safety)               responses, as a possible help in selecting appropriate doses for later studies.   "
203590|NCT00512473|"     Objective: GH induces insulin resistance in muscle and fat and in vitro data indicate that     this may involve crosstalk between the signaling pathways of the two hormones.      Aim: To investigate GH and insulin signaling in vivo in human muscle and fat tissue in     response to GH, GH receptor blockade and insulin stimulation..   "
203591|NCT00512486|"     The primary objective of this study is to investigate the safety of administration of this     drug by increasing doses to male and female adult subjects with mild asthma.   "
203592|NCT00512499|"     Osteoporosis is a very frequent and easily treatable disease. Rates of treatment of affected     patients is very low, as few high risk patients initiate treatment and only a minority of     those pursue treatment for long enough time to prevent fractures. Patients presenting a     fragility fracture after 50 years of age are at high risk of osteoporosis and may represent     the ideal group of patients in which intervention aimed at improving initiation and     persistence on treatment will be most effective.      Our first hypothesis is that the availability of a dedicated nurse practitioner to identify     patients with fragility fractures among patients presenting at fracture clinics of orthopedic     surgeons will increase markedly the rate of identification of osteoporosis.      Our second hypothesis is that giving to both the patient and its primary health practitioner     (PHP) the patient's clinical, biological and radiological data along with individualized care     suggestions will yield significantly better results than giving to the patient and its PHP     generic information on osteoporosis risk, investigation and treatment.   "
203593|NCT00512512|"     This research is being done to evaluate the ability to obtain a liver sample using upper     endoscopy rather than through a laparoscopic procedure. The investigators hypothesize that     the endoscopic transoral route is as effective as the laparoscopic route.   "
203594|NCT00512525|"     Ghrelin administration increases appetite and, in rodents, induces weight gain. The aim of     this study is to investigate the effect of short term ghrelin administration to humans on     metabolism.   "
203595|NCT00512538|"     The purpose of this study is to determine the ability of Apligraf to improve the time to and     incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot     ulcers treated with standard therapy.   "
203596|NCT00512551|"     The goal of this clinical research study is to find out if the expression of certain genes is     linked with the response of cervical cancer to radiation. Researchers will study a large     number of genes located in tumor material to learn this information.   "
203728|NCT00514787|"     Screen for moderate to severe asthma patients with suboptimal asthma control (as defined by     GINA-Guidelines). Document current asthma control status. Re-evaluate asthma therapy and     document new therapy if applicable.   "
203597|NCT00512564|"     Iron overload is well study in Thalassemia patients and it's not only related to blood     transfusions, since intestinal iron absorption is also increased in those patients. Sickle     cell patients didn't developed significant clinical symptoms and signs of iron overload in     spite frequent transfusions. The purpose of this study is to assess the iron overload in     Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and     laboratory studies including Non Transferrin Binding Iron, Labile Iron and Hepcidin, in order     to determine the cardiac and liver iron.   "
203598|NCT00512577|"     TAPS is a sequential trial which aims to investigate whether the administration of a blood     transfusion pre-operatively to patients with sickle cell disease (HB SS or Hb SB0 thal)having     low or medium risk elective surgery increases or decreases the overall rate of peri-operative     complications. The proportion of patients with peri-operative complications in two randomised     groups of transfused and untransfused patients will be compared.   "
203599|NCT00512590|"     The purpose of this pilot study was to test the effects of a 10-week relaxation and guided     imagery intervention on pain perception, functional status, self-efficacy and levels of     distress in Hispanic adults diagnosed with fibromyalgia.   "
203600|NCT00506272|"     ISMAS is designed to test the hypothesis that self management of insulin dependent diabetes     mellitus by selected patients admitted for elective surgery is more efficacious than standard     care with respect to overall glycemic control, attaining finger-stick blood sugars, and     administering insulin.   "
203601|NCT00506285|"     This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in     treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first     trial for adult ADHD. Subjects will experience two screening visits and one baseline visit.     Those who meet admission criteria will enter the double-blind phase. This will involve two     4-week treatment periods one of which will involve the use of MTS and the other a placebo     patch. Subjects who complete the double-blind phase will be allowed to enter a 180-day,     open-label MTS phase designed to assess long-term effects.   "
203602|NCT00506298|"     This trial will assess the efficacy of CRx-401 in lowering FPG levels in patients taking     metformin to treat their diabetes. In addition, this initial trial will evaluate insulin     resistance (HOMA-IR index), HgbA1c levels, glycated protein, LDL, HDL, triglycerides, and     total cholesterol, as well as the safety of CRx-401.   "
203603|NCT00506311|"     Primary Objective:      1. To determine whether the use of a fibrin sealant applied to superficial groin soft tissues     following node dissection can result in decreased cumulative postoperative drainage, earlier     drain removal, and lower incidence of seroma.      Secondary Objectives:        1. To determine the postoperative morbidity rate using fibrin sealant following superficial          groin dissection.        2. To assess patient-valuation of outcome by performing a cost-benefit analysis using a          willingness-to-pay model.        3. To determine if serum levels, lymphatic fluids level, or cutaneous expression of          vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C          (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3)          correlates with nodal tumor burden or development of lymphedema in patients with          melanoma.   "
203604|NCT00506324|"     This project defines the effect on swallowing of intensity modulation during radiotherapy in     an organ preservation treatment involving chemoradiation for 125 oral, laryngeal, and     pharyngeal cancer patients with previously untreated Stage III or IV disease and to identify     optimum treatment strategies. The specific aims are: 1) define the physiologic effects of     chemoradiotherapy with IMRT to various sites in the upper aerodigestive/vocal tract including     the cervical esophagus and the rate at which patients return to oral intake; 2) document the     acute toxicities, late complications, locoregional failure and survival, and the relationship     between fibrosis rating and the measure of laryngeal elevation; 3) determine whether the     patient's swallowing mechanism can compensate for physiologic deficits in swallowing by     introduction of interventions (postural changes, voluntary swallow maneuvers, several bolus     volumes); 4) determine whether time to return to oral intake, effects of swallow maneuvers     and/or volume, presence of an esophageal stricture and the duration of success of dilatation     depends on radiation dose volume to specific structures in the head and neck; 5) define the     relationship of tongue base pressure to development of esophageal stricture. Patients will be     accrued from Northwestern University and University of Chicago. Effects are defined in terms     of swallowing function, morbidity, toxicity and survival. Other outcome measures are the     maintenance of voluntary control (flexibility) of the oropharyngeal region as indicated by     the ability to correctly produce swallow maneuvers; and positive changes in cricopharyngeal     opening duration with normal bolus volume shifts. Patients will be studied pretreatment, and     at 1 month, 3 months, 6 months, 12 months, and 24 months post completion of chemoradiation.     At each assessment, patients will receive a videofluoroscopic assessment of swallowing     utilizing a standard protocol, assessment of xerostomia, mucositis, and fibrosis as well as     assessment of disease status and quality of life scales. Head and neck cancer is a severe     problem that affects public health. Most current treatments are a combination of radiotherapy     with chemotherapy, which can result in severe swallowing problems which may make patients     unwilling to accept this type of treatment. This project attempts to quantify the swallow     problems associated with this specific treatment and the effects of interventions for these     swallow problems.   "
203605|NCT00506337|"     With multicenter randomized control clinical evaluation investigations, the scheme of     integrated medicine treatment of severe acute pancreatitis (SAP) was further improved, and     the therapeutic effects, safety and indications assured. Drawing in latest research fruits at     home and abroad, a clinical practical guideline for integrated medicine of diagnosis and     treatment of SAP would be formed, to be popularized all over China.   "
203606|NCT00506350|"     The present study is designed to evaluate the reactogenicity and immunogenicity of one or two     booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults     aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate     vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634)     will be recruited. This protocol posting deals with objectives & outcome measures of the     booster phase. The objectives & outcome measures of the primary phase are presented in a     separate protocol posting (NCT00309634)   "
203607|NCT00506363|"     The appearance of skin after surgery plays an important role in patient's self confidence and     life style. In fact, Keloids and hypertrophic scars are abnormal wound responses appearing in     predisposed individuals after surgery. Among different kind of lasers, used to improve the     appearance of hypertrophic scars and keloids, pulsed dye laser is now being used successfully     in treatment of scars. Pulsed dye laser is effective in improving the color, height, texture,     and elasticity of scars. Also, treatment with this technique is noninvasive, minimally     uncomfortable, and requires no anesthesia. This study will assess the efficacy and safety of     different onset times of treatment with pulsed dye laser on improvement of surgical scars.   "
203645|NCT00512850|"     RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming. The     use of folic acid may prevent colorectal cancer.      PURPOSE: This randomized clinical trial is studying how well folic acid works compared with a     placebo in preventing colorectal polyps in patients who have had previous colorectal polyps.   "
203608|NCT00506376|"     The primary objective of this study is to assess the preferences (values and utilities) of     women for complications and recurrences associated with the surgical treatment of cervical     cancer. A secondary objective of this study is to compare the preferences of women at     high-risk for developing cervix cancer with the preferences of women who have already been     diagnosed with cervix cancer.   "
203609|NCT00506389|"     The purpose of this trial is to investigate the efficacy, safety and tolerability of     esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.   "
203610|NCT00506402|"     The main objectives of this study are to evaluate the side effects of MKC-1 and to determine     a safe dose of MKC-1 for future studies in patients with hematological malignancies   "
203611|NCT00506415|"     The purpose of this study was to support the optimal use of rivastigmine patch in long-term     treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline     at the target maintenance dose of rivastigmine patch 10 cm^2.   "
203612|NCT00506428|"     The purpose of this study is to examine the consequences of chronic sleep restriction on     nighttime sleep, daytime alertness, performance and memory functions, and metabolic and     cardiovascular function, and to determine if the consequences of chronic sleep restriction     differ between healthy young and older adults.   "
203613|NCT00506441|"     This is a phase III multi-centre study in three periods: the first period is a phosphate     binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the     third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.   "
203614|NCT00506454|"     The purpose of this study is to determine whether a phospholipid emulsion is effective in the     treatment of chronic endotoxemia in hemodialysis patients.   "
203615|NCT00506467|"     Primary Objective:        -  To estimate the accuracy of the pre-operative VRI QRF (Quantitative Regional Function)          results versus the gold standard QRRVP (Quantitative Radionuclide Study of Regional Lung          Ventilation and Perfusion) pre-operative scan.      Secondary Objective:        -  To assess the correlation of the predicted post-operative lung function with the          observed post-operative lung function (FEV1 and DLCO) in patients who underwent surgical          resection. (FEV1 = Forced expiratory volume in 1-second. DLCO = Diffusion capacity for          carbon monoxide. ppo = predicted postoperative.)   "
203617|NCT00506493|"     This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the     outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery     plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The     trial population includes patients requiring valve replacements or repairs, atrial septal     defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft     (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate     Surgical Ablation System can safely and effectively treat persistent AF patients.   "
203618|NCT00506506|"     N-acetylcysteine is used to reduce the risk of injury to the kidney after the administration     of contrast dye. The mechanism and effectiveness of this intervention is not substantiated in     the literature. The investigators hypothesize that serum creatinine will be lower in patients     who receive NAC compared to those who receive the placebo but serum cystatin C will not     change in patients who receive NAC compared to those who receive the placebo. Also urine     creatinine will increase after the administration of NAC compared to before the     administration of NAC.   "
203619|NCT00506519|"     The primary objective of the study is to explore the efficacy and safety of ATryn®     (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC)     associated with severe sepsis, when administered by continuous intravenous (IV) infusion over     five days.   "
203620|NCT00506532|"     1. Working Hypothesis:           The purpose of the trial is to study the effect of exogenous calf surfactant          (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung          injury in lung transplant patients.        2. Aims of the Study:      The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on     the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung     transplant patients.   "
203621|NCT00506545|"     This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH     619734 in subjects with chronic cough from an unknown cause. Subjects will be randomized to     receive SCH 619734 or placebo for 7 days with 7 days' follow-up. After a 6 week washout     period, subjects will be crossed over to the other treatment. The primary objective is to     evaluate the effectiveness of SCH 619734 in reducing cough reflex sensitivity as determined     by a challenge with capsaicin, an agent that induces cough.   "
203622|NCT00506558|"     The purpose of the study is to determine the optimal surgical approach (ventral versus     dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no     established guidelines for the management of patients with CSM, which slowly causes spinal     cord injury in afflicted patients.      This study aims to test the hypothesis that ventral surgery (decompressing the spinal cord     from the front of the neck) and dorsal surgery (decompressing the spinal cord from the back     of the neck) might differ in their overall outcome or major complication rate.   "
203623|NCT00506571|"     Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on     day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a     planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed     every 2 cycles of chemotherapy.   "
203624|NCT00506584|"     The purpose of this study is to determine whether very low birth weight infants (less than or     equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and     human milk-derived nutrition have better health outcomes than babies fed at least some     formula (made from cow's milk)or formula-derived nutrition.   "
203625|NCT00506597|"     The goal of this clinical research study is to allow doctors to use Erwinia L-Asparaginase     (Erwinase®) as a replacement for patients who are allergic to E.coli L-asparaginase or     Pegylated E.coli L-asparaginase as part of the treatment for acute lymphoblastic leukemia     (ALL) or T or B cell lymphoma.      This trial was part of a multi institutional effort by the drug company to make Erwinase     available for use.   "
203626|NCT00512603|"     The association between the levels of d-dimer, fibrinogen and PAI-1 in plasma of elderly     patients admitted to internal medicine departments because of infection and the occurrence of     cardio- and cerebro-vascular disease after discharge   "
203627|NCT00512616|"     This study examines if Ceftriaxone, an antibiotic, will improve symptoms of depression in     Bipolar Disorder.      Purpose: This study will examine whether the drug ceftriaxone can help patients with bipolar     depression during short-term treatment of symptoms such as depressed mood, psychomotor     retardation (slowed down thinking and movements), and problems with sleep. Recent studies     suggest that abnormalities in the brain levels of the chemical glutamate may be involved in     causing depression. Ceftriaxone increases a protein in the brain called GLT1, which is     responsible for regulating brain levels of glutamate.      People between 18 and 65 years of age with bipolar disorder who are currently in a depressive     episode of at least 4 weeks but no longer than 12 months duration may be eligible for this     study.      Participants are admitted to the NIH Clinical Center for about 10 weeks. During the first 1     to 2 weeks, they are evaluated and tapered off any antidepressant or mood stabilizers they     have been taking. They remain free of all medication for 2 weeks and are then randomly     assigned to take either ceftriaxone or placebo for 6 weeks. The study drugs are given     intravenously (through a vein) every day. To minimize discomfort, patients are given a PICC     line - a tube that is inserted in a vein in the arm and remains there for the duration of     drug treatment. This prevents the need for repeated intravenous injections.      Patients have a physical examination at the beginning and at the end of the study and two     electrocardiograms (ECG) during the study. They are evaluated periodically with a series of     psychiatric rating scales to determine the effects of the study drug on mood and thinking and     they have periodic blood tests to assess their health status.      In addition, patients are asked to undergo a lumbar puncture (spinal tap) twice during the     study to collect a sample of cerebrospinal fluid (CSF, the fluid that bathes the brain and     spinal cord). The CSF is examined to try to understand how brain chemicals are related to     depression and to the effects of ceftriaxone. A local anesthetic is given and a needle is     inserted in the space between the bones in the lower back where the CSF circulates below the     spinal cord. A small amount of fluid is collected through the needle. This test is optional.      At the end of the study patients are offered free treatment for up to 3 months with standard     medications for bipolar depression and a referral to a community physician for long-term     treatment will be made.   "
203649|NCT00512902|"     The purpose of this study is to assess the safety and tolerability of imatinib (gleevec) in     subjects who have systemic sclerosis. Imatinib has been approved by the FDA for the treatment     of newly diagnosed adult patients with CML (newly diagnosed adult patients and for the     treatment of patients with an accelerated phase. Imatinib is also approved for the treatment     of patients with a certain type of gastrointestinal cancer (called stromal tumors) but it has     not been approved to treat systemic sclerosis. Imatinib works by interfering with an enzyme     called tyrosine phosphatase resulting in suppression of the immune system. It als interferes     with a protein called platelet derived growth factor receptor (PDGFr) that has been linked to     increased fibrosis.   "
203628|NCT00512629|"     Parenteral nutrition (PN) solutions are life saving in patients with surgical     gastrointestinal diseases. However, the use of PN in pediatric populations, especially     premature infants, is frequently associated with liver injury that may ultimately result in     hepatic failure. In studies conducted in a murine model, we observed that intravenous fat     emulsions (IFE) comprised of omega-3 fatty acids were able to prevent the development of     cholestasis, a common precursor of PN-associated liver disease, as well as reverse     preexisting PNALD through a combination of factors, including improved triglyceride clearance     coupled with anti-inflammatory properties. In a case series treating patients with hepatic     cholestasis, serum bilirubin levels decreased markedly after the parenteral administration of     an omega-3 fatty acid based fat emulsion (Omegaven®). Patients tolerated this therapy and no     adverse reactions attributed to its use were observed. Based on results of these previous     studies, we propose to conduct a randomized trial aiming to gain preliminary evidence of     efficacy of an omega-3 fatty acid based IFE in preventing PNALD in children with intestinal     failure   "
203629|NCT00512642|"     Despite intensive research efforts, there are still no simple and effective screening tools     to detect early lung cancer. The majority of newly diagnosed patients have higher stage,     often disseminated, non-resectable disease. A better understanding of the natural biology and     molecular abnormalities in early lung lesions may aid in the development of more effective     screening tools. This study will investigate the effectiveness of bronchoscopy by white light     (WL) alone and in combination with Lung Imaging Fluorescence Endoscopy (LIFE) for the     detection of early lung lesions in patients with a high risk for developing lung cancer. LIFE     is a FDA approved adjunct to WL bronchoscopy for the screening of lung cancer and this study     will provide a standardized setting in which a direct comparison between a combination of WL     and LIFE versus traditional WL bronchoscopy can be made.      In addition, the study will set the stage for the collection of a unique set of biopsy     specimens that will be used to learn more about the natural biology and the molecular changes     in early lung lesions. We will study abnormalities in p53 by immunohistochemistry and by     molecular analyses. The p53 results will be compared with histological grade and with genomic     instability. Measures for genomic instability will be the loss of chromosomal information and     cellular aneuploidy. Recent advances in molecular pathology, such as the development of Laser     Capture Microdissection (LCM), have made the molecular profiling of these extremely small     lesions feasible. The information obtained by these techniques will be used for comparison     with clinical and exposure information. Future plans include the culturing of bronchial     epithelial cells to study genomic instability in the multistep process of cancer progression.     It is our hope that the application of these new technologies will improve the early     detection of human lung cancer and provide insight into the natural biology and molecular     changes of early lung lesions which may progress towards overt cancers.   "
203630|NCT00512655|"     Background: Approximately 750,000 elderly Dutch people fall at least once a year, which often     results in physical injuries and a fear of falling, with high costs and far-reaching     consequences on functionality, physical activity, quality of life and mental well-being.     Falling is not only a burden for patients, it is also a burden for their caregivers.     Recurrent falling is a complex problem. However, the pathophysiological background of falls,     gait problems and dementia is largely unknown. The general pathophysiological hallmark of     aging is a liability in homeostatic mechanisms of organs. This liability results in an     impaired ability to adapt to stress and in increased biological variation in outcome measures     within individuals. In this study the investigators aim at developing an intervention to     reduce recurrent falling in frail elderly fallers.      Hypotheses: The investigators hypothesize that the intervention program will decrease the     number of falls and fear of falling and increase mental well-being, physical activity and     functional performance in frail elderly people with a history of recurrent falling. In     addition, the burden on the caregivers will be reduced due to the intervention and will be     cost-effective. Furthermore, the investigators hypothesize that patients with a high     short-term intra-individual biological variability in gait and cognition variables have a     higher risk of falling, worse gait performance and cognitive decline after long term     follow-up.      Study Design: Randomized, controlled, single-blind trial.      Study Population: 160 patients referred to a geriatric outpatient clinic, who fell at least     once in the last 6 months and their primary caregivers (N=160).      Intervention: A multifaceted fall prevention program for frail elders to reduce falls     incidence rate, consisting of physical and cognitive components. Moreover, it includes a     training program for caregivers in which they learn to support and give advice to the     patients, aiming to decrease the burden on the caregivers.      Primary Outcome Measures: The fall incidence rate is the primary outcome measure. Total     observation time of falls will be 6 months after the start of the intervention.      Secondary Outcome Measures: In the patients, the secondary outcome measures are fear of     falling (FES), quality of life (MOS-20), depression and general anxiety, functional     performance in activities of daily living, physical activity, mobility, gait parameters, body     sway and biomarkers of endothelial function and frailty. For the caregiver, the secondary     outcome measures are caregiver's burden, mood and quality of life. In addition,     intraindividual variability of cognition, balance and gait in both patients and caregivers,     will be assessed and cost-effectiveness of the intervention will also be determined.   "
203631|NCT00512668|"     This phase I trial is studying the side effects and best dose of temsirolimus when given     together with hormone therapy in treating patients with relapsed prostate cancer. Androgens     can cause the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by     lowering the amount of androgens the body makes. Temsirolimus may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving hormone therapy together     with temsirolimus may kill more tumor cells   "
203632|NCT00512681|"     Patients will be treated with irinotecan (150mg/m2) followed by oxaliplatin (85mg/m2)on day 1     and S-1(80mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned     treatment of maximum 12 cycles of chemotherapy. Response assessement will be performed every     2 cycles of chemotherapy.   "
203633|NCT00512694|"     Lupus is a systemic autoimmune disease that can present with many varied symptoms, including     joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most     common in younger women.      The Duke Lupus Registry will collect information and blood samples from patients with lupus     (systemic lupus erythematosus or cutaneous lupus) seen in the Duke Rheumatology clinics. The     goal of this Registry is to understand how lupus changes over time so that we can improve the     treatment of patients with lupus.   "
203634|NCT00512707|"     The purpose of this placebo-controlled study is to determine if testosterone replacement     therapy, administered by transdermal gel, can improve the response to sildenafil (Viagra R)     treatment in men who have erectile dysfunction (ED) and low testosterone levels.   "
203635|NCT00512720|"     To determine the effect of three different percutaneous revascularization strategies (Balloon     Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower     extremity claudication   "
203650|NCT00512915|"     The purpose of this study is to evaluate the possibility to program the shortest possible     Post Ventricular Atrial Blanking Period (PVAB) and high sensitivity without getting     inappropriate Mode Switch due to Far Field R-Wave sensing when using the new Tendril 1699T     lead. Comparison with Tendril 1688T or 1388T with optimized Post Ventricular Atrial Blanking     (PVAB).   "
203651|NCT00512928|"     Oral anticoagulants that are widely used for the treatment of thrombo-embolic disease exert     their effect by blocking the recycling of vitamin K. Vitamin K acts as a co-factor in the     posttranslational carboxylation of vitamin K-dependent proteins such as osteocalcin and     matrix-gla protein. It is important to quantify the dose-response relationship of the     interaction between vitamin K and oral anticoagulants and to investigate at what dosage     vitamin K will interfere with oral anticoagulants in a clinically relevant way.   "
203652|NCT00513721|"     This is a review of prostate biopsy specimens which show capsular penetration or positive     surgical margins. Patients had surgery performed at William Beaumont Hospital-Royal Oak,     Michigan.   "
203636|NCT00512733|"     Dairy products continue to be an important source of calcium, providing over half the calcium     intake for most individuals. Educational interventions promoting adequate calcium intake with     tools estimating dietary calcium that can be easily utilized by consumers would be a valuable     asset to promoting skeletal health. Validation of these tools against standard dietary     assessment methods enhances their utility. The Dairy Council of California has developed two     dietary calcium questionnaires, one electronic and one in print, using known dietary sources     of calcium including frequency of consumption and portion size. For these questionnaires to     be effective in clinical and research settings they must be a valid measurement of dietary     calcium intake. To measure the validity of the dietary calcium questionnaires one hundred     seventy three women will complete the two dietary calcium questionnaires and one 3-day food     record. The dietary calcium questionnaires will be validated against this established method     of dietary intake measurement. The objective of this study is to validate two dietary calcium     questionnaires that can be used in clinical and research settings against an established     method of dietary intake measurement. It is hypothesized that both dietary calcium     questionnaires will be a valid measurement of dietary calcium intake in women.   "
203637|NCT00512746|"     RATIONALE: Screening tests or exams may help doctors find lung cancer sooner, when it may be     easier to treat.      PURPOSE: This randomized clinical trial is studying screening tests or exams to see how well     they work compared to usual care in finding early stage lung cancer in current or past     smokers with chronic obstructive pulmonary disease.   "
203638|NCT00512759|"     The purpose of this study is to determine whether an early goal-directed decrement of preload     and afterload with a target systolic blood pressure of 90-110 mmHg by aggressive     vasodilatation in patients with acute HF in the non-ICU setting is safe, and leads to a     better clinical and economical outcome   "
203639|NCT00512772|"     The purpose of this study is to determine if the use of antibiotic guidelines and thus     antibiotics can be improved through a description of possible barriers leading to tailored     interventions.   "
203640|NCT00512785|"     The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin.   "
203641|NCT00512798|"     RATIONALE: Drugs used in chemotherapy, temozolomide, work in different ways to stop the     growth of tumor cells, either by killing the cells or stopping them from dividing. Bortezomib     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Giving temozolomide together with bortezomib may kill more tumor cells.      PURPOSE: To determine the best dose of bortezomib and temozolomide and to see how well they     work in treating patients with advanced refractory solid tumors or melanoma.   "
203642|NCT00512811|"     to assess the efficacy of inhaled furosemide in mustard gas exposed patients with acute     respiratory failure   "
203643|NCT00512824|"     This is a long term study on the efficacy of dietary calcium with or without probiotic     strains in reducing the mean number of episodes and duration of diarrheal disease.   "
203644|NCT00512837|"     Although asthma outcomes can be improved with structured care, less than half of people with     asthma achieve good control. Part of the problem is poor adherence with self-monitoring and     preventive drug regimes. This trial will test whether using mobile phone-based monitoring, as     part of a structured care plan, improves clinical outcomes and confidence in people with     poorly controlled asthma.      Adults and teenagers with poorly controlled asthma will be recruited and randomly assigned to     one of two groups. Those in the mobile phone group will monitor their asthma daily using     their mobile phone to record symptoms, medication and lung function. Instantaneous feedback     to their phone will provide a visual indication of asthma control and prompts about therapy.     The patient and their clinician will have web-based access to all readings. People in the     control group will use traditional paper-based monitoring. Under the care of their asthma     nurse, both groups will be treated according to the step-wise approach of the BTS/SIGN asthma     guideline in order to gain control.      We will use the validated Asthma Control Questionnaire to measure control at baseline, three     and six months, and compare improvement in the two groups. We will also assess how confident     people feel in controlling their asthma, using a validated measure of self-efficacy,     attitudes and knowledge.      Technological solutions to long-term healthcare problems are increasingly being sought by     patients, clinicians and policy makers. If successful, our trial could provide timely     evidence for the use of information technology to address the long-recognised problem of poor     asthma control.   "
203648|NCT00512889|"     RATIONALE: Cytotoxic T lymphocytes (CTL) are cells of the immune system that can fight     infections and cancer. These CTL can be manipulated in the laboratory so that they can target     an individual's cancer.      PURPOSE: This early phase trial is studying the feasibility and side effects of intravenous     infusions of CTL generated in the laboratory. To produce the CTL, the study participant's own     immune cells are collected by a procedure called a leukapheresis. The cells then undergo     laboratory processing for three weeks. Part of this processing includes mixing the patients     immune cells with a new kind of cell that has some extra genes added to it. These extra genes     are to teach the participant's own immune cells to become anti-tumor CTL that can attack     the melanoma.   "
203653|NCT00513734|"     Corneal damage in critically ill patients is common. There are currently two popular methods     of treatment in the UK; hydrogel dressings and lubricating ointment. We propose to randomise     patients to have a different treatment for each eye and see which one is more effective.   "
203654|NCT00513747|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Giving fludarabine together with rituximab     may kill more cancer cells. Sometimes the cancer may not need treatment until it progresses.     In this case, observation may be sufficient. It is not yet known whether giving fludarabine     together with rituximab early is more effective than giving fludarabine and rituximab after     observation in treating chronic lymphocytic leukemia.      PURPOSE: This randomized phase III trial is studying fludarabine and rituximab to compare how     well they work when given early or after observation in treating patients with previously     untreated chronic lymphocytic leukemia.   "
203655|NCT00513760|"     Leukotriene receptor antagonists (LTRAs) are frequently prescribed to reduce the symptoms     associated with asthma. Singulair, manufactured by Merck, is a popular LTRA, however its     effectiveness varies greatly between individuals. We are interested in understanding why the     effectiveness of Singulair varies so greatly.      For an oral drug such as Singulair to be effective, the body must efficiently absorb it. We     have found that blood levels of Singulair vary greatly between individuals, and we think that     this variability is responsible for variability in response.      Drug absorption occurs primarily in the intestine. Due to differences in the chemical     properties of drugs, some drugs can be absorbed easily while other drugs require help from     special proteins produced by the cells that line the intestine. These proteins, or     transporters act like turnstiles to allow drugs to move from the intestine to the bloodstream     and are known to be inhibited by components of citrus juice. The activity of a transporter     can be influenced by individual genetic variability.      We think that Singulair requires help from a transport protein to be absorbed and that     genetic variability in this transporter leads to variability in the blood level of Singulair.     In this proposal we will use citrus juice (grapefruit and orange) to inhibit intestinal     membrane transport proteins and show that Singulair requires these transporters to be     efficiently absorbed. Eventually, what we learn from this work will allow doctors to quickly     test individuals with asthma to determine how well they will absorb Singulair and possibly     other LTRAs. Knowing this will allow the doctor to adjust the drug treatment on an individual     basis to maximize benefit in the treatment of asthma.   "
203656|NCT00513773|"     The purpose of this study is to better understand the role of inflammation in the     pathophysiology of abdominal aortic aneurysm. In this study we hope to show better ways of     predicting risk in this condition by using a combination of FDG-PET with CT.   "
203657|NCT00513786|"     Purpose of this study is to determine the effectiveness of the drug combination carboplatin,     paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.   "
203658|NCT00513799|"     The purpose of this study is to determine the natural history of community-associated     Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate     of recurrent infections in those colonized with S. aureus.      In addition, this study will evaluate the efficiency of commonly prescribed decolonization     measures in patients presenting with S. aureus skin and soft tissue infections.   "
203659|NCT00513825|"     Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients     undergoing diagnostic or interventional procedures requiring radiographic contrast agents.     Recent studies have shown benefit in administering Sodium Bicarbonate over normal saline( the     uniformly accepted prophylaxy) in preventing RCIN.But most studies have excluded patients     with history of pulmonary edema, severe heart failure(NYHA 3-4), uncontrolled hypertension or     ejection fraction less than 30%. Therefore the aim of this study is to evaluate the efficacy     of sodium bicarbonate solved in half saline compared with infusion of half saline in     prevention of RCIN in these groups of patients.   "
203660|NCT00513851|"     Open label, phase 1, dose escalation   "
203661|NCT00513864|"     To develop and validate a non-invasive, in vivo, phenotyping method for CYP2D6 using the     non-injurious neuroselective electrical stimulation technique: pain perception threshold/pain     tolerance threshold (PPT/PTT) in children and adolescents with sickle cell disease.   "
203662|NCT00513877|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works     in treating patients with malignant pleural mesothelioma.   "
203663|NCT00513890|"     The purpose of the study is to evaluate, in a prospective way, the clinical, the manometric     an gazometric benefit of non-invasive ventilation (VNI), (INFANTFLOW [EME, Brighton,     England]) during bronchiolitis of the infant compared to a conventional managment.   "
203664|NCT00513903|"     This study will test whether enhanced continuity of pharmacy care that includes increased     communication between inpatient and outpatient settings will improve the appropriateness of     medication therapy and reduce the number of serious adverse drug events, hospitalizations and     unscheduled office visits in vulnerable patients with cardiovascular disease, pulmonary     disease or diabetes.   "
203678|NCT00514085|"     RATIONALE: Interleukin-21 may stimulate white blood cells, including natural killer cells, to     kill melanoma cells.      PURPOSE: This phase II trial is studying the side effects and how well interleukin-21 works     in treating patients with metastatic or recurrent malignant melanoma.   "
203665|NCT00513916|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Eating a     diet high in isoflavones, compounds found in soy foods, may keep cancer from forming.      PURPOSE: This randomized phase III trial is studying the effects of dietary soy on estrogens     in breast fluid, blood, and urine samples from healthy women.   "
203666|NCT00513929|"     The propose of this study is to evaluate if zinc given as an adjunct to standard treatment of     severe pneumonia in young children shortens the duration and reduces treatment failure, and     if these effects are pathogen-dependant.   "
203667|NCT00513942|"     The aim is to test effects of using formal kick counting chart in the third trimester of     pregnancy in an unselected population. The research questions are:      Does Fetal Movement Counting (FMC):        1. Improve the identification of risk pregnancies/pathology?        2. Affect the women's well-being?        3. Stimulate maternal-fetal attachment antepartum?   "
203698|NCT00514384|"     Evaluation of serial measurement of novel biomarker for diagnosis, prognosis or therapy     monitoring in patients presenting with acute decompensated heart failure.   "
203668|NCT00513955|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine,     and prednisolone, work in different ways to stop the growth of cancer cells, either by     killing the cells or stopping them from dividing. Bortezomib may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy     together with bortezomib may kill more cancer cells. It is not yet known whether combination     chemotherapy is more effective with or without bortezomib in treating mantle cell lymphoma.      PURPOSE: This randomized phase II trial is studying combination chemotherapy and bortezomib     to see how well they work compared with combination chemotherapy alone in treating patients     with relapsed or refractory mantle cell lymphoma. Combination chemotherapy alone (Arm I) has     been discontinued April 2012 on recommendation of the DMC.   "
203669|NCT00513968|"     This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110)     combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B     infection.   "
203670|NCT00513981|"     RATIONALE: Drugs used in chemotherapy, such as high-dose methotrexate work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Chemoprotective drugs, such as leucovorin calcium, may protect normal cells from     the side effects of chemotherapy.      PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of     high-dose methotrexate in treating patients with solid tumors.   "
203671|NCT00513994|"     The purpose of the study is to measure how much nitroglycerin or its metabolites may be found     in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied     to the skin of healthy subjects.   "
203672|NCT00514007|"     Multicenter, open-label, phase 1, cohort dose escalation study to determine the Maximum     Tolerated Dose (MTD) on both Once Daily (QD) and Twice Daily (BID) schedules.   "
203673|NCT00514020|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving fluorouracil together with     oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or     gastroesophageal junction cancer.   "
203674|NCT00514033|"     Following licensing of PoliorixTM in Korea, this study will collect safety data about the     routine use of this vaccine in 600 children according to the regulations of Korean Food and     Drugs Administration (KFDA).   "
203675|NCT00514046|"     Background:        -  Medullary thyroid carcinoma (MTC) is common in people with a genetic disorder called          multiple endocrine neoplasia (MEN).        -  Vandetanib is an experimental drug that blocks a defective protein receptor (RET          receptor) found on the surface of cancer cells in people with MEN. It is thought that          this protein is a primary cause of MTC in people with MEN.      Objectives:        -  To study the activity of Vandetanib in children and adolescents with MEN-related MTC by          measuring the change in tumor size, in blood levels of proteins produced the tumor          (calcitonin and CEA) and in tumor-related diarrhea.        -  To determine the safety and tolerability of Vandetanib in children and adolescents.        -  To study how the body handles Vandetanib in children and adolescents.        -  To determine the effect of Vandetanib on the survival of children and adolescents with          MTC.      Eligibility:      -Children and adolescents 5 to 18 years of age with MTC whose tumor cannot be surgically     removed or has grown back after treatment or has metastasized (spread beyond the thyroid     gland).      Design:        -  Patients take Vandetanib once a day in 28-day cycles. The first patients enrolled in the          study are started on a low dose of Vandetanib to determine tolerability.        -  Patients have periodic blood tests, electrocardiograms, and blood pressure measurements          to look for side effects of Vandetanib.        -  Blood tests and imaging scans (MRI, CT, bone and octreoscan) are done every 8 weeks for          the first 32 weeks of treatment and then every 16 weeks for the duration of the          treatment period.        -  Patients who have tumor-related diarrhea keep a daily record of the number and          consistency of bowel movements.   "
203676|NCT00514059|"     An open clinical trial to study the immune response and safety after giving a booster dose     (5th Dose) of a combination vaccine against Diphteria-Tetanus-Pertussis-Polio to healthy     adolescents 15-16 Years of age. The first three doses were given during the first year of     life, according to the Norwegian child immunization program. The fourth dose was given in a     previous clinical trial performed in 1998 when the children were 6-7 years old.      In 2006 there was a change in the child immunization program in Norway: a fourth dose of a     Combination Vaccine Against Diphteria-Tetanus-Pertussis-Polio is given to children 6-7 years     old.      This study will give us information if there is need for an additional dose (5th dose) of a     combination vaccine, containing the pertussis components, before the adolescents are leaving     secondary school.   "
203677|NCT00514072|"     RATIONALE: Vaccines made from tumor cells may help the body build an effective immune     response to kill tumor cells.      PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works     compared with a placebo in treating patients with stage D0 prostate cancer.   "
203679|NCT00514098|"     A new approach to HIV prevention currently being studied includes the use of topical     microbicides and orally administered anti-HIV drugs. The purpose of this study is to better     understand the impact of microbicides in women who are diagnosed with HIV-1 during     participation in previous microbicide trials.   "
203680|NCT00514111|"     The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients     treated with pegylated-interferon or conventional-interferon and ribavirin, and to     investigate the associated factors with RVS, by means of retrospective analysis.   "
203681|NCT00514137|"     This phase II trial is studying how well sunitinib works in treating patients with relapsed     multiple myeloma. Sunitinib may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the cancer   "
203682|NCT00514150|"     Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients     undergoing diagnostic or interventional procedures requiring radiographic contrast agents.     Recent studies have shown benefit in administering Sodium Bicarbonate over normal saline( the     uniformly accepted prophylaxy) in preventing RCIN.Therefore the aim of the study is to     evaluate the efficacy of sodium bicarbonate solved in normal saline compared with infusion of     normal saline in prevention of RCIN.   "
203683|NCT00514163|"     The primary objective of this study is to compare tumor response rate of the test     arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable     pancreatic cancer   "
203684|NCT00514189|"     Primary Objectives:        1. To determine the feasibility of delivering autologous dendritic cells (DCs) loaded with          acute myelogenous leukemia (AML) lysate plus messenger RNA (mRNA) to AML patients          following consolidation therapy.        2. To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA.        3. To quantitate immune responses in patients who receive autologous DCs loaded with AML          lysate plus mRNA.      Secondary Objectives:        1. To evaluate minimal residual disease following DC therapy using the polymerase chain          reaction assay for the Wilm's Tumor-1 gene.        2. To asses the disease-free and overall survival of AML patients who receive the          autologous DCs loaded with AML lysate plus mRNA.   "
203685|NCT00514202|"     Dextroamphetamine is commonly used to treat ADHD, and recent evidence suggests that this     medication may decrease drug use in individuals dependent on cocaine. Thus, the present pilot     study will determine the ability of dextroamphetamine to treat individuals with both cocaine     dependence and ADHD.   "
203686|NCT00514215|"     RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving an injection of GM-CSF     before cryotherapy and inhaling GM-CSF after cryotherapy may interfere with the growth of     tumor cells and shrink the tumor. Giving cryotherapy together with GM-CSF may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving cryotherapy together with GM-CSF     works in treating patients with lung metastases or primary lung cancer.   "
203687|NCT00514228|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with     liver cancer that cannot be removed by surgery.   "
203688|NCT00514241|"     The aim of platelet rich plasma (PRP) application is to accelerate the healing cascade via     application of elevated cytokine concentrations released during platelet degranulation.      This is a prospective randomized study of the effect of autologous platelet concentrate     application during surgical closure following a vein harvest during coronary bypass surgery.     This prophylactic measure will be compared to standard surgical closure techniques with the     primary outcome being the incidence of leg wound infection.   "
203689|NCT00514254|"     RATIONALE: Learning about the risk factors for endometrial cancer in black women may help the     study of endometrial cancer in the future.      PURPOSE: This clinical trial is studying risk factors for endometrial cancer in black women.   "
203690|NCT00514267|"     To determine the feasibility and safety of administering YM155 in combination with docetaxel   "
203691|NCT00514280|"     This study will test whether a short interview session about lead and secondhand tobacco     smoke can help pregnant women reduce their exposure to lead and secondhand smoke. Both lead     and secondhand tobacco smoke can cause problems with a pregnancy. The best way to prevent     exposure to lead and secondhand tobacco smoke is to recognize the sources and avoid them.      Non-smoking African-American and Hispanic pregnant women between 18 and 49 years of age who     live in Washington, D.C. may be eligible for this study.      Participants are randomly assigned to one of two study groups. Both groups have a 30-minute     one-on-one session with a member of the study staff. The content of the session differs     between groups. In addition, all women undergo the following tests and procedures:        -  Answer questions about themselves, their pregnancies, diet, home and smokers in the          home.        -  Requested to provide permission to obtain medical records of children older than 12          months of age who have ever been seen at Children's National Medical Center.        -  Blood draws at least four times during the study: at the time of enrollment, during the          second trimester of the pregnancy, during the third trimester, and at the time of          delivery. Up to three optional blood samples may also be requested, one during each          trimester of the pregnancy. Blood samples are used to measure lead, cotinine (a chemical          the body makes out of nicotine) and hematocrit (a test for anemia).        -  Collection of umbilical cord blood at the time of delivery.        -  Answer questions after the delivery about the patient's health, the delivery and the          baby.   "
203692|NCT00514293|"     RATIONALE: Bexarotene and tretinoin may cause tumor cells to look more like normal cells, and     to grow and spread more slowly. Drugs used in chemotherapy, such as cisplatin, carboplatin,     docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving bexarotene and tretinoin     together with combination chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving bexarotene     together with tretinoin and combination chemotherapy works in treating patients with stage     III or stage IV non-small cell lung cancer.   "
203693|NCT00514306|"     Multicenter, open-label, phase 1, cohort dose escalation study to determine the maximum     tolerated dose (MTD) of 3 intermittent OSI-906 dosing schedules.   "
203694|NCT00514332|"     To evaluate wether colorectal stenting carry a significant clinical advantage   "
203695|NCT00514345|"     RATIONALE: Studying the genes expressed in samples of blood from young patients with cancer     treated with ifosfamide may help doctors identify risk factors for kidney damage.      PURPOSE: This clinical trial is looking at the CYP3A5 gene to see if having the gene may be a     risk factor for kidney damage in young patients with cancer treated with ifosfamide.   "
203696|NCT00514358|"     The purpose of this study is to determine the pharmacokinetics of fluconazole in infants and     evaluate the dose exposure relationship of current fluconazole dosing in infants who are     receiving fluconazole for the prevention or treatment of systemic fungal infections.   "
203697|NCT00514371|"     This is a phase 2/3, open label trial for patients with relapsed-refractory multiple myeloma.     Study agent is tanespimycin (KOS-953), at three different dose levels in combination with a     fixed dose of bortezomib.   "
203699|NCT00514397|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together     with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation     therapy works in treating young patients with pontine glioma.   "
203700|NCT00514410|"     To determine whether giving folic acid to people with depression will help their     antidepressants work better. If folate does help antidepressants to work better, then it will     provide a safe, simple and cheap way of improving the treatment of depression.   "
203701|NCT00514423|"     Participation in one of the three interventions psychoeducation by professionals,     psychoeducation by peer-moderators, or video-education can reduce the rehospitalisation rate     of patients with schizophrenia compared to a control group.   "
203702|NCT00514436|"     Asthma among low-income, minority children remains a prime example of health disparities that     are resistant to change. Controlled demonstrations of reductions in disproportionate hospital     or emergency care are limited. We performed a controlled clinical trial of an Asthma Coach     to reduce hospitalizations among low-income, African American children.   "
203703|NCT00514449|"     The purpose of this study is to examine whether antiviral medication will help improve     psychotic symptoms and cognition in individuals early in the course of schizophrenia or     schizoaffective disorder who are exposed to herpes simplex virus, type 1 (HSV 1), a virus     that causes commonly occurring and recurrent cold sores.   "
203704|NCT00514462|"     The purpose of this study is to determine that 830nm diode laser directly above the     transverse carpal ligament (between the pisiform and navicular bone) on subjects' wrists, and     test this therapeutic effect.   "
203705|NCT00514475|"     The purpose of the study is to determine if outcome for patients with mantle cell lymphoma is     improved by adding radioimmunotherapy to high-dose regimen before auto-transplant in patients     who are not in CR after induction therapy.   "
203706|NCT00514488|"     This is a phase III multicenter, open-label study designed to investigate the efficacy     (hematological response, cytogenetic response and molecular response) and feasibility     (tolerance, compliance and safety) of the tyrosine kinase inhibitor imatinib mesylate     (formerly STI 571, GLIVEC, Novartis Pharma) at conventional dose (400 mg/daily) if compared     with high dose (800 mg/daily) (serial number protocol ICSG/CML/022) in patients with Ph+     chronic myeloid leukemia (CML) in chronic phase (CP) previously untreated, at high Sokal     risk.   "
203707|NCT00514501|"     This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS     patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123     for the detection of myocardial ischemia. Readers independent of the clinical study centers     will review results of imaging studies in a blinded fashion at an imaging core lab. The     resulting independent reading of the images will be compared against the truth standard for     ACS.   "
203708|NCT00514514|"     The purpose of this study is to compare renal function of immunosuppressive regimens with     different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low     dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.   "
203709|NCT00514527|"     Two Phase III trials to demonstrate the efficacy and safety of oritavancin in the treatment     of complicated skin and skin structure infections (cSSSI) have been completed.      The pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the     potential to be used safely and effectively when given either as a single dose or as an     infrequent dose for cSSSI. Data from animals support this theory.      SIMPLIFI has been designed to evaluate the efficacy and safety of either a single dose of     oritavancin or an infrequent dose of oritavancin (First dose on Day one with an option for a     second dose on Day five) compared to the previously studied dosing regimen of 200mg     oritavancin given once daily for 3 to 7 days.   "
203710|NCT00514540|"     The goal of this clinical research study is to learn about how effective 2 different     schedules of chemotherapy drugs (Paraplatin [carboplatin] plus Taxotere [docetaxel] and     VePesid [etoposide] plus Platinol-AQ [cisplatin]) are in the treatment of patients with     anaplastic prostate cancer. The safety of both therapy combinations will also be studied.   "
203711|NCT00514553|"     This study will compare the effectiveness of two interventions to help women make informed     choices about whether or not to undergo an invasive procedure (amniocentesis or chorionic     villus sampling) for prenatal testing. The interventions are: 1) conscious deliberation     (getting women to focus on and engage in the decision) and 2) unconscious deliberation     (getting women not to focus on the decision). Studies suggest that some women are ambivalent     about their decisions regarding invasive prenatal testing and those with the most ambivalence     experience greater conflict about the decision. Techniques to reduce ambivalence through     conscious or unconscious deliberation might lead to better informed choices. The two methods     will also be compared with standard counseling for prenatal testing decisions.      Women 18 years of age or older who are referred for prenatal genetic counseling to consider     invasive prenatal testing and who have not previously undergone prenatal testing may be     eligible for this study.      Participants complete a questionnaire before and after receiving standard genetic counseling.     They are then randomly assigned to one of three study groups:        -  Standard genetic counseling (control group): Receives no further intervention beyond          standard counseling.        -  Conscious deliberation: Participants complete a form that focuses their attention on the          pros and cons of invasive prenatal testing. This is followed by a brief questionnaire to          evaluate time spent thinking about the session and the ease of completing the session.        -  Unconscious deliberation: Participants are provided a distraction task to complete          during the session, such as a word or number puzzle and are told they will be asked          about their decision regarding invasive prenatal testing at the end of the session. This          is followed by a brief questionnaire to evaluate time spent thinking about the session          and the ease of completing the session.      Participants are contacted by telephone 1 month after the counseling session to find out what     they decided regarding invasive prenatal testing and to assess any conflict they experienced     about the decision.   "
203727|NCT00514774|"     The purpose of this study is to evaluate the safety of the drug ursodiol (ursodeoxycholic     acid, UDCA) in people with Huntington's disease (HD) and to explore how the compound is     processed by the body.   "
203712|NCT00514566|"     Within the last decade the customary trend of using non absorbable sutures has changed, with     numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming     comparable wound strength with significantly lower incidence of wound complications. It was     the objective of this randomized clinical trial to compare two universally accepted suture     materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline     abdominal closure in the Indian context.   "
203713|NCT00514579|"     The hypothesis of the study is double unit umbilical cord blood transplantation in adults     will be associated with a one year survival rate of at least 40%.   "
203714|NCT00514592|"     A single center observational study. Observing the time between cerebrovascular symptoms and     Carotid Endarterectomy (CEA) and patient outcome. An intervention at 17 of the 29 study     months aimed at reducing the delay and increasing the patient safety. Main outcome is to     measure the reduction in recurrent stroke with decreased delay to CEA.   "
203715|NCT00514605|"     Each year up to 22 million persons in the US are tested for HIV. Currently available rapid     tests do not provide test results for at least 30 minutes from the collection of serum and     plasma from the subject. Providing accurate test results in less than a minute would make it     easier to make timely decisions about treatment and counselling.      This study will compare results of an experimental rapid test to existing standards to     determine if the test can reliably and accurately diagnose HIV in less than one minute.   "
203716|NCT00514618|"     A. Null Hypothesis:      In term pregnancies complicated by diabetes, there is no difference in the time interval from     start of induction to delivery when outpatient cervical ripening and labor induction is     initiated with orally administered misoprostol, a prostaglandin El analogue, compared to     placebo.      B. Specific aims:        1. Demonstrate that oral misoprostol is effective for cervical ripening compared to placebo          when given in an outpatient basis to women with pregnancies complicated by diabetes          mellitus.        2. Demonstrate that oral misoprostol can be administered safely in an outpatient setting.          The patients will be observed for a period of four hours in an outpatient antepartum          testing unit after the medication is administered to demonstrate fetal well being and          verify that there is no evidence of uterine hyperstimulation. (We acknowledge that          markers of serious adverse maternal and neonatal outcomes are rare, and can only be          adequately addressed in large multicenter trials.)        3. Assess the cost differential in inpatient and outpatient utilization of misoprostol for          cervical ripening and labor induction. In order to estimate the impact that outpatient          cervical ripening may have on total hospitalization costs, we will use daily hospital          charges and published data regarding pharmaceutical costs.   "
203717|NCT00514644|"     The odontological radiology method Panorama is known to be able to spot calcifications in the     area of the carotid arteries. The calcifications could be carotid stenoses which is     affiliated with an increased risk of stroke. The study aims to investigate if panorama     examinations can be used as a starting point for further investigation of the carotid     arteries.   "
203718|NCT00514657|"     The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce     regeneration of periodontal tissue lost by progression of periodontitis and evaluated the     safety of such induction.   "
203719|NCT00514670|"     The objective of the trial is to assess the impact of a disinfection and hand hygiene program     on absenteeism in elementary school classrooms. Students in intervention classrooms will use     alcohol-based hand sanitizers at school, and their classrooms will be disinfected using     quaternary ammonium wipes. We hypothesize that the use of disinfectants and hand hygiene     products in elementary school classrooms will reduce absenteeism.   "
203720|NCT00514683|"     The general purpose of this trial is to investigate the efficacy and safety of 4 dose     strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with     idiopathic pulmonary fibrosis.      The primary objective of this study is to demonstrate whether at least one dose strategy is     superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital     Capacity (FVC).      As a secondary objective, additional parameters will be assessed in order to differentiate     between dose strategies on the basis of safety and efficacy   "
203721|NCT00514696|"     The purpose of this study is to evaluate the safety of GCS-100 and the biologic activity of     GCS-100 in subjects with chronic lymphocytic leukemia.   "
203722|NCT00514709|"     DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs     for immunization in infancy, while offering the benefit of a reduced number of injections,     and potentially of an increased acceptance.      Primary Objectives:        -  To describe the antibody persistence at 12 to 18 months following a three-dose primary          series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14          weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.        -  To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18          months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or          Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine          given at birth.      Secondary Objective:        -  To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when          administered concomitantly with Oral Polio Vaccine (OPV).   "
203723|NCT00514722|"     This is a pilot study designed to evaluate the safety and feasibility of performing umbilical     cord blood transplants in adults with high-risk hematopoietic malignancies. A novel     myeloablative preparative regimen will be used. One, up to a maximum of three cord blood     units will be administered to facilitate engraftment.   "
203724|NCT00514735|"     The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac     Ablation System compared to medical therapy in the persistent and long-standing persistent     atrial fibrillation population.   "
203725|NCT00514748|"     Bilateral DIEP flap needs two groups of vessel pedicles. We suppose that the bilateral DIEP     flap may survive on one vessel pedicle by means of interconnection of bilateral DIEA. This     study is aimed to build a interconnected vessel system of bilateral DIEP flap based on one     vessel pedicle and observe its survival in breast reconstruction.   "
203726|NCT00514761|"     The purpose of the study is to assess if there is benefit when using AZD6244 in the treatment     if metastatic colorectal cancer in comparison with another treatment called capecitabine.     This study will also assess how safe and well tolerated AZD6244 is.   "
203729|NCT00514800|"     Design: Community based randomised trial with follow up after 12 months Participants: 360     patients admitted with stroke or TIA within the past 9 months will be recruited from the     wards or outpatients and randomly allocated into two groups. All patients will be visited by     the specialist nurse at home at baseline when she will measure their BP and administer a     questionnaire. The questionnaire and BP will be repeated at 12 months follow-up by another     researcher blind as to whether the patient is in intervention or control group.      Intervention: Intervention patients will be given a validated home BP monitor and support     from the specialist nurse. Control patients will continue with usual care (BP monitoring by     their practice).      Main outcome measures in both groups after 12months: 1.Change in systolic BP 2.Cost     effectiveness: Incremental cost of the intervention to the NHS and incremental cost per     quality adjusted life year gained.      Study hypothesis. Home blood pressure monitoring with nurse support wil lead to lower blood     pressure after 12 months compared with usual GP care   "
203730|NCT00514813|"     To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in     patients treated with Dynepo.   "
203731|NCT00514826|"     The purpose of the study is to investigate the effect of an altitude sojourn on patients with     the obstructive sleep apnea syndrome   "
203732|NCT00514839|"     In a randomized controlled trial, patients recruited in a general hospital and fulfilling     criteria for regular consumption (more than 60 days within the last three months), dependence     or abuse of prescription drugs will be randomly allocated to two conditions:(1) Intervention     group consisting of two counselling sessions based on Motivational Interviewing plus a     personalized feedback, (2) Control group receiving a booklet on health behavior.      Outcome assessment will be conducted after 12 months. The hypothesis is that counseling leads     to greater reduction in consumption of prescription drugs (including discontinuation) and     elevated readiness to change at follow-up.   "
203733|NCT00514852|"     The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will     be compared to a currently-available artificial tear   "
203734|NCT00514865|"     The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients     with Recurrent Major Depressive Disorder   "
203735|NCT00514878|"     The primary purpose of this prospective cohort study is to develop a simplified risk model     for post-discharge nausea and vomiting (PDNV) in adult same-day surgery patients in the US     that will allow clinicians to identify those patients who would benefit from prophylactic     antiemetic strategies.   "
203736|NCT00514891|"     High-dose vitamin A to children above 6 months of age reduces all-cause mortality by 23-30%.     The WHO recommends vitamin A supplementation (VAS) with the first vaccine after 6 months of     age. However, the effect of providing VAS with vaccines has never been investigated. We have     hypothesised that the effect of VAS depends on the immune stimulus at the time of     supplementation. Hence, the effect might vary depending on which type of vaccine it is given     with. In particular, we hypothesised that VAS might be beneficial when given with measles     vaccine but not when given with DTP vaccine. Normally the first vaccine after 6 months of age     would be a measles vaccine, but many children come late for their DTP vaccinations and     receive DTP alone or together with measles vaccine. Hence, it is important to study whether     the effect of VAS is the same irrespective of the vaccine(s) administered at the same time.      Guinea-Bissau has not yet implemented the WHO vitamin A policy of providing VAS with     vaccines, but plans to do so within the next years. Together with the Ministry of Health in     Guinea-Bissau, the Bandim Health Project (BHP) in Guinea-Bissau will investigate the effect     on mortality and morbidity of implementing the WHO vitamin A policy in Guinea-Bissau. This     will be done in a large randomised trial.      BHP has a demographic surveillance system (DSS) which has followed a population of now more     than 150,000 individuals for almost 30 years. Children will be randomised to receive VAS or     placebo with their first vaccine after 6 months of age, and will be followed through the DSS     to assess mortality and morbidity. Based on previous observations, the effects of VAS might     differ according to sex and season. The interaction between VAS, sex, and season will also be     studied in the present trial. By identifying situations where VAS may be beneficial,     ineffective, or even harmful the study may contribute importantly to optimising the VAS     policy for low-income countries.   "
203737|NCT00514904|"     The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority     of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
203738|NCT00514917|"     The primary objective was to evaluate and compare the efficacy of androgen deprivation with     or without docetaxel as determined by the median progression free survival (PFS) over the     period of 18-month therapy and at least 18-month follow-up.      The secondary objectives were:        -  To assess cancer specific survival;        -  To compare overall survival between the 2 treatment groups;        -  To evaluate patient-reported outcomes including quality of life, fatigue, and sexual          functioning as measured by 3 different assessments.   "
203739|NCT00514930|"     The primary aim for this trial is to assess whether the RFA aspirator device is safe and of     clinical benefit in patients with primary or secondary malignant liver tumours   "
203740|NCT00514943|"     The primary objective of this study is to explore the efficacy of BIBW 2992 compared with     cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after     failure of platinum-containing therapy. In addition, the trial aims to clarify the influence     of EGFR genotype on tumor response to the treatment regimens.   "
203741|NCT00514956|"     A great many soldiers are returning from Iraq and Afghanistan with symptoms of Post Traumatic     Stress Disorder (PTSD). Clinical experience with many people has shown the effectiveness of     the techniques of Energy Psychology for rapidly alleviating PTSD symptoms. The study proposes     to determine whether a very brief course of treatment (3 sessions) with a common form of     Energy Psychology called Emotional Freedom Techniques (EFT) has an effect on the stress     biochemistry of subjects, by measuring their levels of stress hormones (cortisol, DHEA)     before and after treatment.   "
203742|NCT00514969|"     This is a phase II, multi-center, open-label, non-randomized trial. During Part 1 of the     trial, patients will receive once daily oral administration of STI571 at a dose of 600 mg for     24 weeks. After completing 24 weeks of therapy, patients may be eligible to receive     additional therapy during Part 2 of the trial provided that, in the opinion of the     investigator, the patient has benefited from treatment with STI571 and in the absence of     safety concerns. During Part 2 (which is of indefinite duration), patients will continue to     receive STI571 on a daily basis until either death, the development of intolerable toxicity     or the investigator feels it is no longer in the patient's best interest to continue therapy,     whichever comes first.   "
203783|NCT00515502|"     GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being     developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long     duration of action of GSK573719 when administered via inhalation in animal models supports     the potential for use as a once-daily bronchodilator for COPD.   "
203743|NCT00514982|"     This study will determine if medical treatment of colitis (inflammation of the colon     resulting in loose bowel movements, rectal bleeding, and belly pain) that is used for other     colitis conditions, such as Crohn's disease and ulcerative colitis, is safe and effective for     treating colitis in patients with Hermansky-Pudlak syndrome (HPS). HPS is a hereditary     disorder that causes albinism, visual impairment, and abnormal bleeding. Some patients also     develop colitis, pulmonary fibrosis, and kidney disease.      Patients with HPS and colitis who are 18 years of age or older may be eligible for this     study. Participants receive treatment for their colitis symptoms with one or more of several     study drugs, which include mesalamine (5-ASA), corticosteroids, infliximab and     6-mercaptopurine, adalimumab and tacrolimus. The drugs are added to the treatment plan one at     a time to find the combination that works best for the individual patient. Patients who     respond to one or more of the medications may continue treatment with that same combination     for up to 6 months.      Regular clinic visits are scheduled for blood tests, symptoms ratings questionnaires and     periodic physical examinations and colonoscopies to measure the response to treatment and     evaluate any side effects.   "
203744|NCT00514995|"     The purpose of this research study is to study the effectiveness, tolerability and safety of     sodium oxybate in outpatients with binge eating disorder.   "
203745|NCT00515008|"     The purpose of this study is to obtain preliminary data on the effects of Tai Chi on     musculoskeletal pain, fatigue, sleep quality, psychological distress, physical     performance,and health status in 60 patients with fibromyalgia.   "
203746|NCT00515021|"     To determine if nighttime administration of an aldosterone antagonist would effectively lower     peak plasma PAI-1 levels more effectively than morning administration.   "
203747|NCT00515034|"     The purpose of this study is to assess the safety and tolerability of doripenem compared to     imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The     study population will include hospitalized patients (or patients resident in a chronic health     care facility) who have a diagnosis of either Ventilator associated pneumonia or complicated     Intra-abdominal Infection.   "
203748|NCT00515047|"     People with atopic dermatitis (AD), or eczema, are susceptible to skin infections and     inflammations. Some individuals with AD develop a condition known as eczema herpeticum (EH)     following exposure to the herpes simplex virus (HSV). The purpose of this study is to     identify the genetic determinants that lead people with AD to develop EH and similar     conditions caused by other viruses.   "
203749|NCT00515060|"     The goal of this clinical research study is to improve understanding of the sensory qualities     of patients who have pain caused by cancer therapy. This information will add to the     understanding of what causes this pain and may lead to better management of the pain. The     specific goal is to define the sensory capacity of patients in their area of pain as a     consequence of cancer therapy compared to another body area without pain.   "
203750|NCT00515073|"     Primary Objectives:        -  To evaluate the results of Paclitaxel and pelvic radiation in pelvic confined papillary          serous carcinoma of the endometrium for both local control and overall survival.        -  To evaluate the toxicity of Paclitaxel and pelvic radiation.        -  To collect and evaluate patients' quality of life/symptom assessment data.   "
203751|NCT00515086|"     This study will define the safety and efficacy of Everolimus (RAD001) administered daily in     patients with glioblastoma multiforme (GBM)   "
203752|NCT00515099|"     Antithymocyte globulin (e.g., Thymoglobulin®) is an antibody preparation that is commonly     used to treat and prevent organ transplant rejection. The START trial aims to determine     whether antithymocyte globulin (ATG) treatment can halt the progression of newly diagnosed     type 1 diabetes when given within 12 weeks of disease diagnosis.   "
203753|NCT00515112|"     The purpose of this study is to determine whether prostate cancer growth can be slowed in     patients who receive Androgel® 1% at 10 gram dose.   "
203754|NCT00515125|"     The purpose of this study is to determine the best form of dietary intervention to     undernourished elderly individuals in care homes.      The research aims to test the null hypothesis that there is no difference between oral     nutritional supplements and dietary advice as the first line treatment for malnutrition.   "
203755|NCT00515138|"     This study seeks to determine the maximum tolerated dose of bortezomib in combination with     rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary     refractory aggressive B-Cell Non-Hodgkin's lymphoma (diffuse large B-cell, mantle cell,     follicular grade III, transformed lymphoma). Subjects will be enrolled in cohorts of 3 at     each bortezomib dose level, starting at 1 mg/m(2), and escalating to 1.3, 1.5, and 1.7     mg/m(2). Bortezomib will be given on days 1 (prior to rituximab) and 4, rituximab 375     mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days     6-13 or pegfilgrastim on day 6.   "
203756|NCT00515151|"     Health-care-acquired infections are of tremendous importance for patients, especially     catheter-associated infections. More than 40% of all bloodstream infections are associated     with central venous catheters (CVC; catheters which are inserted into a large vein near the     heart). Of all patients that acquire such an infection 1% to 5% die as a result from it. The     insertion site is the main source of contamination and infection. In general, bacteria of the     skin are the cause of infection, especially in short-term CVCs (10-14 days). Therefore it is     necessary to efficiently disinfect the skin for the preparation and care of CVC insertion     sites. Several substances are used for disinfection. Alcohol-based disinfectants are mainly     used in Central Europe, other preparations contain povidine-iodine or chlorhexidine.     Alcoholic disinfectants have a rapid initial effect, chlorhexidine shows an additional     remanent (longer lasting) effect. A further substance, octenidine dihydrochloride, also     demonstrated a remanent effect in a pilot study with neurosurgical patients. The purpose of     our study is to compare an alcohol-based disinfectant containing octenidine dihydrochloride     with a pure alcoholic disinfectant regarding efficacy and tolerability in patients receiving     a CVC for a minimum of 5 days.   "
203757|NCT00515164|"     The purpose of this study it to evaluate the efficacy and safety of the 20 mL BLVR System in     patients with advanced upper lobe predominant emphysema.   "
203784|NCT00515528|"     The purpose of this study is to determine if an experimental melanoma vaccine can produce an     immune response in patients with metastatic melanoma, and if combining this vaccine with the     drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor     shrinkage.   "
203758|NCT00515177|"     Chronic insomnia is a major public health problem that affects about 10% of adults and is     associated with serious and distressful health consequences such as depression, anxiety and     reduced quality of life. Sleep medications are effective, but side effects, costs and     uncertain long term efficacy call for non-pharmacologic alternatives. Mindfulness-Based     Stress Reduction (MBSR), a standardized program of training in mindfulness meditation and     yoga, is a promising new approach for treating chronic insomnia. MBSR was developed to     facilitate adaptation to the stressors of medical illness. It is hypothesized that     mindfulness training reduces arousal and unhelpful cognitions that promote and sustain     chronic insomnia. The Mindfulness Versus Pharmacotherapy trial (MVP#1) is a pilot study     designed to establish the feasibility and determine the optimal design for a full-scale trial     comparing MBSR to prescribed sleep medication for treatment of chronic insomnia. For this     pilot, we will randomize persons with primary chronic insomnia (actual sample of 30 persons)     to 2 groups : 1) MBSR (8-weeks of group instruction followed by 3-months of home practice);     and 2) PCT (3 mg of LUNESTA(eszopiclone) nightly for 8-weeks followed by 3-months of as     needed use). Both groups will have telephone monitoring for side effects, adherence     tracking, and objective sleep assessment by actigraphy. The primary outcomes are sleep     quality, sleep quantity and insomnia severity assessed by well-validated self-report scales,     objective sleep parameters measured by wrist actigraphy, depression and anxiety symptoms,     health-related quality of life and workplace productivity. We hypothesize that those in the     MBSR group will have improved sleep outcomes. Outcomes will be assessed at 8-weeks (the end     of the active intervention phase) and 5 months follow-up. Outcomes will be compared to     baseline values and measures reflecting proposed mechanisms of action to determine if     clinically important impacts are likely to be obtainable in a full-scale trial. After     follow-up data have been collected, participants will be invited to participate in focus     groups to share their impressions of the study interventions to identify issues that could be     addressed in a full-scale trial. Our long-range goal is to provide evidence-based     recommendations for safe, practical and cost-effective non-pharmacologic treatment options     for chronic insomnia.   "
203759|NCT00515190|"     Randomized phase II study designed to evaluate the efficacy and safety of continuous S-1 plus     oxaliplatin versus intermittent S-1 plus oxaliplatin as first-line therapy in patients with     recurrent and/or metastastic gastric carcinoma. Within 2 weeks of the end of induction     chemotherapy of 6 cycles with S-1 plus oxalipatin, patients who don't experience progression     will be randomized to the continuous S-1 plus oxaliplatin arm or the intermittent S-1 plus     oxaliplatin arm in a 1:1 ratio.   "
203760|NCT00515203|"     The purpose of this study is to evaluate the safety and tolerability of romiplostim (AMG 531)     in the treatment of thrombocytopenia in pediatric subjects with chronic ITP. We will also     evaluate the efficacy of romiplostim (AMG 531) and characterize the pharmacokinetics of     romiplostim (AMG 531). It is anticipated that romiplostim (AMG 531), when given at an     effective dose and schedule, will be well tolerated treatment for thrombocytopenia among     pediatric subjects with chronic ITP.   "
203761|NCT00515216|"     This study is for patients who have stomach cancer or cancer of the lower part of the     esophagus that has spread to other organs. There are many different chemotherapy treatments     for this type of cancer. At the present time, there is no general agreement on the way to     choose the most beneficial therapy for an individual patient. Patients with different genetic     backgrounds may respond differently to the same chemotherapy treatments. In this study the     investigators will use a certain genetic difference in an important gene (thymidylate     synthase or TS gene) to see whether treating patients who have a particular type of that gene     will respond better to a standard chemotherapy regimen. The investigators are hoping that by     treating patients according to their genes, that they may respond to treatment of their     cancer better and it will help the investigators choose cancer treatments better in the     future.   "
203762|NCT00515229|"     Our data indicate that the CFTR-molecule functions as a transporter for     sphingosine-1-phosphate and sphingosine or regulates the uptake of these sphingolipids by     epithelial cells. The disturbed uptake of sphingosine and sphingosine-1-phosphate over the     cell membrane results in an accumulation of ceramide in the cell membrane, which finally     triggers a pro-inflammatory and pro-apoptotic status in the respiratory tract of cystic     fibrosis patients. Amitriptyline reduces the cera-mide levels in the lung tissue, normalises     the activity of cytokines and prevents constitutive cell death of epithelial cells observed     in CFTR-deficient mice. Most important, amitriptyline prevents pulmonary infections of     CFTR-deficient mice with P. aeruginosa. These effects of amitriptyline may result in an     improved lung function of cystic fibrosis patients.   "
203763|NCT00515242|"     The purpose of this study is to compare the relative effectiveness of three relaxation     treatments (therapeutic massage, thermotherapy, and time in a relaxing environment) in     reducing anxiety in persons with Generalized Anxiety Disorder.   "
203764|NCT00515255|"     The purpose of this study is to investigate the effect of NPL-2003 on the symptoms of     Obsessive Compulsive Disorder (OCD) in an adolescent population.   "
203765|NCT00515268|"     The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a     lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin     (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support     GSK256066 dose selection for future studies in COPD patients.   "
203766|NCT00515281|"     The purpose of this study is to determine whether inhaled nitric oxide improves the     neurological outcome for premature infants.   "
203767|NCT00515294|"     The aim of this study is to develop information about the acute and residual effects of a new     product being targeted to young adults. Using a double placebo-controlled 2 X 2 factorial     model study design, we will compare the acute and residual effects on driving impairment of     caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated     placebo. Under the alcohol conditions, participants will receive sufficient alcoholic     beverage to attain a blood alcohol concentration (BAC) of .12 g%. Participants will be 144     undergraduate and graduate students, and recent college graduates.   "
203785|NCT00515541|"     This study is to determine the effects of Lovaza in platelet function studies   "
203786|NCT00515554|"     This study is designed to test:        1. in patients with negative positron-emission tomography (PET) after 2 cycles of          BEACOPPesc chemotherapy: whether the number of cycles can be reduced without          compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles)        2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc          chemotherapy by adding Rituximab improves PFS.   "
203787|NCT00515567|"     The goal of this study is to use the tissues from the explanted lungs in order to better     study the cause of pulmonary fibrosis at a cellular level.   "
203788|NCT00515580|"     This is a pilot study to determine the usefulness of a newly developed, minimally invasive     tongue suture procedure for people with obstructive sleep apnea.   "
203866|NCT00509756|"     The primary purpose of this study is to evaluate the safety, tolerability and     pharmacokinetics of a single dose of FXR-450 in healthy Japanese men.   "
203768|NCT00515307|"     Patients with homozygous familial hypercholesterolemia has very high serum cholesterol levels     despite receiving lipid lowering drugs (e.g. statins, etc). Most of such patients die before     the age of 20 due to myocardial infarction, etc. Orthotopic liver transplantation (OLT) is an     effective treatment for that. Hepatocyte transplantation is an alternative to OLT that may     help to overcome the shortage of donor organs. There have been reports of successful     treatment of different kinds of metabolic liver disorders by hepatocyte transplantation. The     major problem with hepatocyte transplantation is that the source of hepatocytes is very     limited. Bone marrow stem cells are the potential source of hepatocytes. In the in-vitro     culture system successful and efficient transdifferentiation of mesenchymal stem cells into     hepatocytes has been documented. We have already shown that infusion of mesenchymal stem     cells is safe and feasible in cirrhosis (Mohamadnejad M, et al. Arch Iran Med 2007; In     Press). In this study, 2 patients with homozygous familial hypercholesterolemia will be     included. The bone marrow of healthy volunteers with a normal lipid profile will be taken,     then bone marrow mesenchymal stem cells (MSCs) will be cultured, and then MSCs will be     trans-differentiate into hepatocytes, and the cells will be infused through the portal vein     into the patients. The duration of follow up will be 6 months post-transplantation.   "
203769|NCT00515320|"     The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets     (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic     Disorder. The study will also investigate the effect of fluoxetine on the improvement of     symptoms and the effects on daily living of the patient's family.   "
203770|NCT00515333|"     The primary objective of the study is to investigate the effects of oral TRx0014 at three     doses (30, 60 and 100 mg tid) compared with placebo on cognitive ability in patients with     mild or moderate dementia of the Alzheimer type. Cognitive ability will be measured by the     Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog). The primary evaluation     will be made at 24 weeks.   "
203771|NCT00515346|"     The purpose of this study is to evaluate the safety and performance of the Xpert(TM)     self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in     patients undergoing percutaneous intervention for the treatment of documented chronic     critical limb ischemia (CLI).   "
203772|NCT00515359|"     RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI     Studies   "
203773|NCT00515372|"     The goal of this behavioral research study is to find a quick and effective way to identify     depression in patients with ovarian, peritoneal, or fallopian tube cancer. Another goal of     this study is to compare an intervention program with enhanced standard care to see which     may be more effective in improving quality of life for these patients.   "
203774|NCT00515385|"     The primary purpose of this phase 1, double-blind, cohort study is to evaluate the safety,     tolerability, and pharmacokinetics of escalating doses of MGAWN1 administered as a single     intravenous (IV) infusion to healthy adults. Subjects will be enrolled sequentially into one     of 5 dose-level cohorts, with 8 subjects in each cohort. Six subjects in each cohort will     receive MGAWN1 (a Neutralizing, Humanized, Monoclonal Antibody (IgG1k) to West Nile Virus)     and 2 will receive a saline control.   "
203775|NCT00515398|"     The purpose of this study is to see how molecules called pharmacological chaperones affect     the cells of patients with Pompe disease. The study will last 1 or 2 visits which will     include a blood collection, urine collection, and two skin biopsies. Information will also be     collected from the medical records about disease history and diagnosis. Patients will not     receive any study medication.   "
203776|NCT00515411|"     Chemotherapy given together is a standard way to treat your cancer. One standard treatment     includes a combination of docetaxel, cisplatin, and fluorouracil. However, the original     combination of these three drugs can cause many side effects. This study is being done to     find out if these three drugs can be given at lower doses more often, with fewer side effects     and still maintain the same benefit as the standard way of giving this three drug     combination. If your tumor overexpresses a protein called Her2, you are also eligible to     receive trastuzumab with chemotherapy. Trastuzumab is a medicine that has been approved by     the US Food and Drug Administration for the treatment of Her2 positive breast cancer.     Trastuzumab is now also a standard treatment in combination with chemotherapy for the     treatment of Her2 positive stomach cancer. If your tumor is Her2 positive, you would receive     the modified administration schedule of docetaxel, cisplatin, and fluorouracil with     trastuzumab.   "
203777|NCT00515424|"     This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and     explore the effect of the compound on intraocular pressure in subjects with ocular     hypertension.   "
203778|NCT00515437|"     To determine safety, tolerability and preliminary efficacy of intraglandular injections of     MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients   "
203779|NCT00515450|"     This randomized controlled, multi-center study will carry out to assess the efficacy of     GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis     based on the changes in Quantitative Myasthenia Gravis score (QMG score) as primary endpoint,     and in addition, to assess the safety of GB-0998   "
203780|NCT00515463|"     The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled     syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density     (BMD).   "
203781|NCT00515476|"     The purpose of the present study is to characterize the quality of HDL-Cholesterol in     patients with metabolic syndrome and reduced blood HDL-Cholesterol levels and to examine the     effect of exercise training on the vasculoprotective effects of HDL-Cholesterol in these     patients. Additionally the investigators aim to investigate the endothelial function,     oxidative stress and the regenerative capacity of the endothelial progenitor cells in     patients with metabolic syndrome and the changes dependent on physical activity of patients.   "
203782|NCT00515489|"     The purpose of this study was to evaluate the safety of risperidone treatment in acute     psychotic patients that require an admission into emergency department. The effectiveness of     risperidone in controlling acute psychotic symptomatology and incidence, severity and risk of     psychomotor agitation in acute psychotic patients was also studied.   "
203867|NCT00509769|"     This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab     emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal     growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).   "
203789|NCT00515593|"     The objectives of the study are        -  to describe the quality of life at the beginning of the Preotact® treatment and at the          end of the observational period (Qualeffo-41 questionnaire)        -  pain assessment at the beginning of the Preotact® treatment and at the end of the          observational period (VAS score)        -  to describe bone mineral density at the beginning of the Preotact® treatment and at the          end of the observational period (T-Score)        -  to describe incidence of bone fractures caused by osteoporosis as well as of other          pathological findings of the skeleton after the beginning of the Preotact® treatment        -  to describe serum level of calcium and the bone resorption marker desoxypyridinoline          (DPD) and N- respectively C-terminal crosslink-telopeptide (CTX and NTX) at the          beginning of the Preotact® treatment and at the end of the observational period (only in          subgroup of patients, where the physician sees a need to measure these parameters)        -  to document all adverse drug reactions after the beginning of the Preotact® treatment        -  the analysis of subgroups with different risk for bone fractures caused by osteoporosis          at the beginning of the Preotact® treatment        -  to assess the manageability and functioning of the Pen system for injection of Preotact®          (self administered questionnaire)   "
203790|NCT00515606|"     to assess the effectiveness of helium:oxygen mixture adjunct with non-invasive ventilation in     sulfur mustard exposed patients with acute decompensation   "
203791|NCT00515619|"     The main purpose of this trial is to determine safety and efficacy of Lacosamide under long     term therapy.   "
203792|NCT00515632|"     Type 2 diabetes mellitus is a metabolic disorder that is primarily characterized by insulin     resistance, relative insulin deficiency, and hyperglycemia. People with type 2 diabetes are     at high risk of many serious diabetic complications, including cardiovascular disease,     blindness, nerve damage and kidney damage. Balaglitazone is a thiazolidinedione derivative     that is being developed as an oral anti-diabetic drug to improve blood glucose control in     patients with type 2 diabetes. The purpose of this study is to assess if additional treatment     with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve     blood glucose control and decrease the daily insulin dose compared to placebo, but with less     impact on weight gain and oedema than pioglitazone (Actos®) 45 mg.   "
203793|NCT00515645|"     Head down tilt (HDT) was widely used to simulate microgravity effects on cardiovascular     system. HDT could be a suitable model of water immersion (WI) which is also used to simulate     the cardiovascular effects of microgravity and which is not easy to study in laboratory. To     define the possibility to simulate immersion by HDT, a comparison between these models is     required. A comparison between WI and few angles during HDT seems necessary to understand     which angle is more adapt.      The immersion induces an increase of the central blood volume. This increase is caused by a     redistribution of blood from peripheral portions of the body to the intrathoracic     circulation. It seems to load cardiopulmonary and arterial baroreceptors. These baroreceptors     bring into play autonomic nervous system (ANS) activation and induce a bradycardia.      HDT induces an increase in central blood volume as supported by the central venous pressure     and cardiac volume increase and in return, MSNA and heart rate decrease. These cardiovascular     effects seem to be the same as the thermoneutral immersion and suggest that the ANS     activation is the same during HDT and WI.      Nevertheless, a few previous studies about ANS in HDT indicate some discordant results: a     sympathetic decrease was reported but several results show an increase of parasympathetic     activity linked with a trend of increase of arterial baroreflex. The aim of this study is to     assess ANS activity in HDT on different angles (-6° and -15°) and WI. The investigators     suppose an increase of parasympathetic activity during WI corresponding to parasympathetic     activation during HDT especially at -6°.   "
203794|NCT00515658|"     The aim of this study is to evaluate the safety and efficacy of theta-burst rTMS in patients     with major depression. Patients will be randomized to receive ether left-sided intermittent     theta-burst rTMS or rigt-sided continuous theta-burst rTMS or sham theta-burst rTMS over two     weeks period with an option for an additional two weeks period, depending on treatment     response. Clinical assessments will be performed weekly by the Hamilton depression rating     scale. In addition, standard neurophysiological assessment of cortical excitability will be     done.   "
203795|NCT00515671|"     The President's New Freedom Commission on Mental Health has called for a transformation of     the mental health system to partner with consumers of those services in delivering effective     interventions focused on recovery, and the Department of Veterans Affairs (VA) has developed     a Mental Health Strategic Plan to address these recommendations. One promising approach is to     implement Illness Management and Recovery (IMR), a structured curriculum to help mental     health consumers manage their illnesses and pursue goals related to recovery from mental     illness.      IMR was developed from a review of effective approaches for illness self-management training     in persons with severe mental illness. The 9-month curriculum is taught using motivational,     educational, and cognitive-behavioral techniques, and incorporates five evidence-based     practices: education about mental illness, strategies for increasing medication adherence,     skills training to enhance social support, relapse prevention planning, and coping skills     training. The program was developed for widespread dissemination and includes a manual,     worksheets, an introductory video, a clinical training video, a fidelity scale, and     informational brochures for consumers, family members, clinicians, and administrators.   "
203796|NCT00515684|"     The purpose of this study is to determine whether topical bevacizumab is safe or not when     used in corneal neovascularization for long term period.   "
203797|NCT00515697|"     The purpose of this study is to determine whether ramucirumab is effective treatment in     participants with metastatic renal cell carcinoma who have developed progressive disease or     become intolerant to tyrosine kinase inhibitor therapy.   "
203798|NCT00515710|"     Several subjects enrolled in a multi-site, gene transfer clinical study to evaluate the     intrahepatic administration of AAV2-hFIX16 vector for the treatment of severe hemophilia B     between 2001 and 2009. As the US FDA has established guidelines for the long-term follow-up     (LTFU) of subjects receiving investigational gene therapy products, this protocol seeks to     characterize the clinical outcome and the type and seriousness of adverse events following     the AAV gene transfer. The primary study tools will consist of annual history/physical     examination and blood tests, as well as periodic liver ultrasound, to characterize clinical     outcomes. Where possible, data will be obtained for up to 15 years following hepatic     AAV2-hFIX16 gene transfer.   "
203799|NCT00515723|"     Hyperglycemia and type 2 diabetes mellitus are more common in schizophrenia than in the     general population. Type 2 diabetes mellitus is characterized by disturbances in insulin     action on skeletal muscle, liver and adipose tissue. Diabetes causes increased morbidity and     mortality due to acute (e.g., diabetic ketoacidosis) and long-term (e.g., cardiovascular     disease) complications. The combination of hyperglycemia, dyslipidemia and abdominal     adiposity is even more strongly associated with increased cardiovascular morbidity and     mortality. The association of type 2 diabetes and hyperglycemia with schizophrenia was first     noted prior to the introduction of antipsychotic medications, suggesting that these patients     may be at increased risk. Since then, however, additional glucoregulatory abnormalities     (e.g., new onset diabetes), dyslipidemia, and increased weight and adiposity have all been     associated with antipsychotic medications. Concern about antipsychotic effects on glucose,     lipids and adiposity has increased recently, focusing on the widely-used newer medications,     clozapine and olanzapine. Increased abdominal adiposity can secondarily decrease insulin     sensitivity and antipsychotics can increase adiposity. However, medication effects on glucose     control and insulin action may also occur independent of differences in adiposity. This     project aims to a) evaluate the effects of selected antipsychotic medications on insulin     action in skeletal muscle (glucose disposal), liver (glucose production) and adipose tissue     (whole-body lipolysis), b) evaluate the effects of selected antipsychotic medications on     abdominal adipose tissue mass, total body fat and total fat-free mass, and c) explore the     longitudinal effects of treatment with selected antipsychotics on glucose tolerance, lipid     profiles, abdominal adipose tissue mass, total body fat and total fat-free mass. These     hypotheses will be evaluated by measuring 1) whole-body glucose and lipid kinetics with the     use of gold-standard stable isotope tracer methodology, 2) body composition using dual     energy x-ray absorptiometry and magnetic resonance imaging, and 3) longitudinal changes in     glucose tolerance and lipid profiles. The aims will be addressed in non-diabetic     schizophrenia patients chronically treated with risperidone, olanzapine, clozapine,     quetiapine, ziprasidone, or haloperidol, and untreated healthy controls. Re-evaluations will     also be performed in patients who are randomized to switch from their current antipsychotic     (from the above groups) to risperidone, olanzapine, quetiapine, or ziprasidone for 6 months.     Relevant data is critically needed to target basic research, identify long-term     cardiovascular consequences, and plan therapeutic interventions.   "
203800|NCT00515736|"     Critically ill patients are generally exposed to an increased oxidative stress, which is     proportional to the severity of their condition. Endogenous antioxidant (AOX) defenses are     depleted particularly in those patients with intense inflammatory response. The hypothesis     tested is that early I:V: administration of a combination of AOX micronutrient supplements     (Se, Zn, Vit C, Vit E, Vit B1) would improve clinical outcome in selected critically ill     patients, by reinforcing the endogenous AOX defenses and reducing organ failure.   "
203801|NCT00515762|"     Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has     been recently described. This pilot trial explores the capacity of a cooling cap (Elasto-gel)     to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel     regimens.   "
203802|NCT00515775|"     The purpose of the study is to investigate, whether the FeNO concentration of asthmatic     children is influenced differently by inhaled corticosteroid compared to inhaled     corticosteroid + long acting beta agonist. The study hypothesis is that the FeNO     concentration is more decreased in patients with a combination therapy compared to those with     a corticosteroid mono therapy.   "
203803|NCT00515788|"     Objectives:      - To determine the safety, tolerability and maximum tolerated dose (MTD) of oral temozolomide     using a 7 days on and 7 days off regimen combined with intrathecal liposomal cytarabine     (DepoCyt) in patients with neoplastic meningitis from solid tumors and systemic lymphoma.   "
203804|NCT00515801|"     We aim to demonstrate that oral administration of glibenclamide stimulates pancreatic     glucagon secretion during hypoglycemia in insulin-deficient (C-peptide negative) patients     with type 1 diabetes when compared to type 1 diabetic patients with residual insulin     secretion (C-peptide positive).   "
203805|NCT00515814|"     The outcome of this trial will reveal the possibilities of the retinal implant to improve the     situation of patients with hereditary retinal blindness caused by degenerations of the outer     retina. This pilot study will give important information on safety and efficacy of     sub-retinal implants.   "
203806|NCT00515827|"     Raltegravir (MK-0518) is an HIV-1 integrase inhibitor with potent in vitro activity against     HIV-1 strains including those resistant to currently available antiretroviral drugs. The     purpose of this study is to assess the effectiveness of raltegravir in further reducing viral     load in HIV infected patients that have already achieved viral suppression below the level of     detection of standard viral load assays when added to antiretroviral therapy (ART).   "
203807|NCT00515840|"     Breathing retraining supervised by a physiotherapist will result in improvements in the     quality of life and asthma control of patients treated for asthma in the community with     symptoms suggestive of dysfunctional breathing.      To investigate the effects of breathing retraining on clinical and physiological parameters     of asthma control, to identify the characteristics of patients who benefit, to perform a     health economic evaluation.   "
203808|NCT00515853|"     The purpose of this study is to determine whether biofeedback exercises improve anal     continence after anterior resection for rectal cancer.   "
203809|NCT00515866|"     The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436     that can be given in combination with gemcitabine chemotherapy for the treatment of     pancreatic cancer.   "
203810|NCT00515879|"     This study will assess the effectiveness of D-cycloserine combined with cognitive-behavior     therapy in treating people with social anxiety disorder.   "
203811|NCT00515892|"     RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal     cells. This may be effective treatment for Non-Hodgkin's lymphoma (NHL) that has not     responded to chemotherapy, surgery or radiation therapy.      PURPOSE: Phase 1 dose escalation study to determine the maximum tolerated dose of CAT-8015     immunotoxin in treating patients who have Non-Hodgkin's lymphoma and do not respond to     treatment.   "
203812|NCT00515905|"     One-lung ventilation; organ protection; volatile anesthetics      One-lung ventilation has become a common procedure for thoracoscopic surgery. Two hypothesis     will be tested in this study:        1. Are inflammatory mediators increased in the re-ventilated lung after short-period          pulmonary collapse?        2. Does Sevoflurane influence the production of inflammatory mediators in the re-inflated          lung? Therefore, this study will elucidate the potential protective effect of a volatile          anaesthetic (sevoflurane) on the production of inflammatory mediators by the respiratory          compartment of the lung, i.e. the alveolar epithelium.             -  Trial with immunomodulatory product / biological   "
203813|NCT00515918|"     The purpose of this project to examine brain functions and behavior related to ID including     sensory ,motor, cognitive and social /emotional functioning, and address unanswered questions     about brain and behavior impacts of different timing of ID(pre- and /or postnatal ID) in     infants.   "
203838|NCT00516243|"     This randomized phase I trial studies the side effects and best dose of defined green tea     catechin extract in treating women with hormone receptor-negative stage I-III breast cancer.     Green tea extract contains ingredients that may prevent or slow the growth of breast cancer.   "
203814|NCT00515931|"     Gastrointestinal stromal tumors (GISTs) are generally considered resistant to radiation, but     no prospective trials addressing efficacy and tolerability of radiation therapy have been     carried out. Limited clinical experience suggests that selected GIST patients may benefit     from palliative radiation therapy. The purpose of this prospective, non-randomized,     multicenter study is to evaluate efficacy and safety of palliative radiation therapy in GIST     patients who have progressive GIST during or after tyrosine kinase inhibitor therapy.   "
203815|NCT00515944|"     Xeomin® is a Botulinum neurotoxin type A preparation free of complexing proteins, i.e. free     of bacterial proteins other than the active toxin. Injected into the muscle, Xeomin® causes     local weakening. Botulinum toxin type A is used for certain neurological and aesthetic     treatments. This study will investigate the migration potential of Xeomin®.   "
203816|NCT00515957|"     In this study NPC patient will receive 4 days of treatment with CD45 antibody followed by one     dose of LMP1- and LMP2-CTL. From this, we can learn if treating the patient first with the     CD45 antibody will also let LMP1- and LMP2-CTL we give grow better. In addition, we will find     out, if LMP1- and LMP2-CTL are safe and have enhanced anti-tumor activity in comparison to     standard EBV-CTL.      This study aims to determine the safety of autologous LMP1- and LMP2- specific cytotoxic     T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (MAb) in patients with     EBV-positive nasopharyngeal carcinoma (NPC).      And to obtain information on the expansion, persistence and anti-tumor effects of autologous     LMP1- and LMP-2 specific CTL given after lymphodepletion with CD45 MAb in patients with     EBV-positive NPC.   "
203817|NCT00515970|"     Basal cell carcinoma (BCC) is the most frequent skin cancer. Uncontrolled growth destroys     local anatomic structures. There are various treatment alternatives with different recurrence     rates and expenses. After surgical excision, the recurrence rate is in between 3 and 4% and     the procedure is relatively expensive. Photodynamic therapy as well as imiquimod 5% are     expensive therapies with high recurrence rates, that lack histologic evidence of BCC.     Cryosurgery and curettage are inexpensive, although the recurrence rates are higher than     after surgical excision.      This prospective, randomized trial compares recurrence rates, cosmetic outcome, and     surgery-related complications after curettage versus surgical excision in nodular and     superficial BCC. About 600 tumors will be included. One half is treated by curettage, the     other half by surgical excision. The follow-up period is four years. If the difference     between recurrence rates is ≤7% and the cosmetic outcome as well as the surgery-related     complications are not worse after curettage, surgical excision must be considered an     overtreatment.   "
203818|NCT00515983|"     Background: Sixteen melanoma patients (1 stage IIC, 8 stage III, and 7 stage IV) were treated     in a Phase I study to evaluate safety and immune responses, with a vaccine (DC/Apo-Nec)     composed of autologous dendritic cells (DCs) loaded with a mixture of apoptotic/necrotic     melanoma cell lines (Apo-Nec).      Methods: PBMC were obtained from leukapheresis and DCs were generated from monocytes cultured     in the presence of GM-CSF and IL-4 in serum-free medium. Immature DCs (iDCs) were loaded with     gamma-irradiated Apo-Nec cells and injected id without adjuvant. Cohorts of four patients     were given four vaccines with 5, 10, 15, or 20 x106 DC/Apo-Nec per vaccine, two weeks apart.      Results: The vaccine was well tolerated in all patients. Toxicity to vaccine was mild, and     the toxicity-limiting dose has not been reached. We found that 42.3 ±13.7 % melanoma     patients´ iDCs were able to phagocyte Apo-Nec cells wich induced DCs maturation, as evidenced     by increased expression of CD83, CD80, CD86, HLA class I and II compared to iDCs. Also, after     phagocytosis, a 75.2 ±16 % reduction in Dextran-FITC endocytosis was observed compared to     iDCs. CCR7 was upregulated upon Apo-Nec phagocytosis in DCs from all patients and accordingly     in vitro DC/Apo-Nec cells were able to migrate towards MIP-3 beta. The DTH score increased     significatively in the patients after the first vaccination and slightly decreased by the     fourth vaccine (Mann-Whitney Test, p<0.05). For patient #1 a positive DTH reaction was     detected to her own tumor irradiated cells. The presence of CD8+ T lymphocytes specific to     gp100 and Melan A/MART-1 Ags were studied by tetramers binding in HLA-A*0201 patients (7 /15     patients) before and after vaccination. Two patients who remain NED increased Ags their     specific T lymphocytes after vaccination. No humoral responses to Apo-Nec cells were     detected. With a mean follow-up of 44.5 months post-surgery, the stage IIC pt is NED, 7/8     stage III pts are NED and 7/7 stage IV patients have progressed.      Conclussions: We conclude that DC/Apo-Nec vaccine is well tolerated, it induces specific     immunity against melanoma Ags and in stage III patients it may prolong disease-free survival,     affording protection from relapse in an adjuvant setting.   "
203819|NCT00515996|"     We plan to examine genetic polymorphism of catechol-O-methyltransferase in panic disorder and     neurobiological changes of panic disorder patients after 12 weeks of pharmacotherapy with     paroxetine. We plan to include 40 panic disorder patients and 40 normal control subjects in     this study for 3 years.   "
203820|NCT00516009|"     Acute low back pain is one of the most common reasons for all physician visits(1).     Phospholipase A2 (PLA2), a potent inflammatory mediator, has demonstrated to be released by     discs following injury(4). Clinical practice and animal research suggest that lumbar     radicular pain is the result of inflammation of the nerve root in the epidural space(5). The     study will evaluate the efficacy of intravenous Dexamethasone for acute disc     herniation-induced sciatica. 40 patients aged 18 years or older, who will be transferred to     the emergency room due to sciatic pain will be blindly randomized to receive Dexamethasone 30     mg IV for 3 days an tapering off, 10 mg daily, or normal saline. 20 patients will be in each     group. The patients will continue their standard care during the study period. Follow up will     last for 3 months. Mann-Whitney test will be used for parametric correlation, Wilcoxon for     numeral and x² for categorial variables. Dexamethasone IV can help physicians in treating     patients with acute sciatic pain.   "
203821|NCT00516022|"     Mistletoe extract is one of the most common complementary treatments used in Europe. Recent     basic studies reported tumor response and survival prolongation in number of treatments with     Mistletoe preparations. There are evidence based data for using this drug as side effect     reducer when use in combination with chemotherapy regimen treatment. Other clinical data,     although not well based is that complementary treatment when used in combination with the     common oncology treatment has tumor response effect. Combinations with platinum compound and     a third generation cytotoxic agent have been accepted as 'standard of care' for patients with     advanced NSCLC. The combination of platinum compound and one of the new agents are associated     with response rates of 30-40% and a median survival of 8-11 months for advanced NSCLC     patients with good performance status.      Study objective: Improvement in QOL, Improvement in the toxicity profile of the chemotherapy     treatment.   "
203822|NCT00516035|"     Over the past decade, avian influenza (AI) has become a major health concern. The development     of safe and effective vaccines against avian strains infecting people is important. The     purpose of this study is to determine the safety of and immune response to a new AI vaccine     in healthy adults against the H7N3 strain of avian influenza.   "
203907|NCT00516464|"     Evaluation of ranibizumab on the ease and procedure and complication in proliferative     diabetic retinopathy (PDR) requiring vitrectomy.   "
203823|NCT00516048|"     The primary purpose of this study is to assess the anti-exenatide-antibody response to     exenatide re-exposure as measured by anti-exenatide antibodies and incidence of     treatment-emergent allergy and hypersensitivity reactions following a period of treatment     interruption, in patients previously exposed to exenatide.   "
203824|NCT00516061|"     Vascular endothelial growth factor(VEGF) appears to play a central role in the process     leading to peritoneal angiogenesis and increased level of VEGF may contribute to high     peritoneal small-solute transport rate (PSTR) in continuous ambulatory peritoneal dialysis     (CAPD) patients in adult. In children, lymphatic absorption of solute is greater than adult.     VEGF-C is related to lymphogenesis, but its role in peritoneal solute transport rate is not     known. In this study, we evaluated possible relationship between dialysate VEGF and VEGF-C     levels and PSTR in children.   "
203825|NCT00516074|"     This study will explore the effect of exenatide (given twice a day) versus placebo (given     twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug     exposure in patients with type 2 diabetes.   "
203826|NCT00516087|"     Patients have a type of cancer called nasopharyngeal carcinoma (NPC) which has either come     back, not gone away or is at high risk for coming back after the best treatment we know for     this disease. We are inviting patients to participate in a research study using a new     experimental therapy consisting of special immune system cells called LMP1- and LMP2-specific     cytotoxic T lymphocytes (LMP1- and LMP2-CTLs).      Some patients with nasopharyngeal carcinoma show evidence of infection with the virus that     causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their     diagnosis. EBV is found in the cancer cells of almost all patients with advanced stage NPC,     suggesting that it may play a role in causing the disease. The cancer cells infected by EBV     are able to hide from the body's immune system and escape destruction. We want to see if     special white blood cells, called T cells, that have been trained to recognize and kill     special parts of EBV infected cells can survive in blood and affect the tumor.      We have used this sort of therapy to treat a different type of cancer that occurs after bone     marrow and solid organ transplant called post-transplant lymphoma. In this type of cancer the     tumor cells have 9 proteins made by EBV on their surface. We grew T cells in the laboratory     that recognized all 9 proteins and were able to prevent and treat post-transplant lymphoma.     However nasopharyngeal carcinoma tumor cells only express 2 EBV proteins (LMP1 and LMP2) on     their surfaces. In a previous study we made T cells that recognized all 9 proteins and gave     them to patients with NPC. While some patients had a response, only a few patients had their     cancer completely go away. We are now trying to find out if we can improve this treatment by     growing and giving T cells where more of the cells will recognize two of the proteins     expressed on NPC cells called LMP1 and LMP2. These special T cells are called LMP1- and     LMP2-CTLs. These LMP1- and LMP2-CTLs are an investigational product not approved by the Food     and Drug Administration.   "
203827|NCT00516100|"     Pemetrexed is an FDA-approved treatment for advanced lung cancer but the response rate is     still very low. Bortezomib is currently approved to treat myeloma in patients who have     already been treated. Currently, multiple studies are actively investigating how well     bortezomib works with other drugs. This study is testing how much bortezomib can be given to     advanced lung cancer patients who have already received one treatment. This study will also     see how well bortezomib and pemetrexed work together to treat lung cancer patients.   "
203828|NCT00516113|"     The objective of this study is to explore the onset of action when serotonin reuptake     inhibitors are used to treat premenstrual dysphoric disorder   "
203829|NCT00516126|"     Aim of this study is to investigate whether patients preoperatively treated with     acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts     of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE     (thrombocyte function analyzer).   "
203830|NCT00516139|"     This study is being conducted to determine the safety and tolerability of lamotrigine (LTG)     in elderly patients with epilepsy. This study will be carried out using an extended-release     formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.   "
203831|NCT00516152|"     The primary objective of this study is to assess the safety and efficacy of performing     unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative     therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to     demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40%     at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to     demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.   "
203832|NCT00516165|"     Laboratory studies have shown that RAD001 can prevent cells from multiplying. Consequently,     the study drug is being tested in medical conditions in which excessive cell multiplication     (as in cancer) needs to be stopped. The main purpose of this research study is to find the     highest dose of RAD001 that can be given safely (without causing severe side effects) and to     learn the effects (good or bad) RAD001 has on participants with liver cancer.   "
203833|NCT00516178|"     A large body of evidence has accumulated showing that n-3 PUFAs exert extensive cardiac     effects. The development of commercial solutions of FO opens perspectives for therapeutic     applications in patients with acute cardiac conditions.the 3 following hypotheses will be     addressed in patients requiring cardiac surgery under cardiopulmonary bypass or after     myocardial infarction:perioperative /post-PTCA intravenous fish oil modifies the composition     of membrane phospholipids in platelets and cardiac cells, blunts the physiological response     to cardiac surgery/myocardial infarction, and reduces the incidence of arrhythmias, and     reduces the occurrence of systolic dysfunction.   "
203834|NCT00516191|"     The primary objective of this study is to evaluate the safety and tolerability of four dose     levels of liposomal doxorubicin, melphalan, and bortezomib in patients with     relapsed/refractory MM and to identify a maximum tolerated dose (MTD) of this combination.   "
203835|NCT00516204|"     A screening project of diabetics with a very high cardiovascular risk (e.g. diabetes plus     coronary heart disease) who already receive cholesterol-lowering therapy. Lipid profile and     rate of patients who are treated to target (which is <70mg/dl for such patients with very     high risk) are screened. The doctors therapy decisions after the screening will be documented     and 8-10 weeks later the lipid profile of each patient will be evaluated again. Our aim is to     evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and     to underline the importance of treating patients to their cholesterol targets.   "
203836|NCT00516217|"     RATIONALE: Monoclonal antibodies, such as galiximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them.      PURPOSE: This phase II trial is studying how well galiximab works in treating patients with     relapsed or refractory Hodgkin's lymphoma.   "
203837|NCT00516230|"     Correct identification of Lynch syndrome at the time of colorectal cancer presentation is     important. We aim to find best ways to screen patients with colorectal cancer in Korea.   "
203839|NCT00516256|"     The aims include:        1. To measure the effect of the three study conditions on Quality of Life (QOL).             -  CHESS and Cancer Information Mentor will not differ initially (6 weeks) or late in               treatment (6 months) in QOL             -  CHESS +Cancer Information Mentor will have the largest impact on QOL (initially and               late in treatment) and will be significantly better than either CHESS or Cancer               Information Mentor alone.        2. To measure potential intervening or mediating processes, so that we can determine how          CHESS and the Cancer Information Mentor produce associated QOL benefits.        3. To conduct exploratory use analyses examining which types of CHESS content, sequential          patterns of content use, or other characteristics of use behavior are associated with          greater pretest-posttest improvements in QOL.        4. To conduct a secondary analysis exploring whether men whose partners have actively used          CHESS do better than those whose partners did not use CHESS.   "
203840|NCT00516269|"     The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl     (Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma,     myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have     completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug     will also be studied. Another goal of the study is to see how certain cytokines change while     patients undergo chemotherapy or hormonal treatment.   "
203841|NCT00516282|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide and VNP40101M, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Temozolomide may also stop the growth of tumor cells by blocking blood flow to the     tumor.      PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M when     given together with temozolomide and to see how well it works in treating patients with     progressive or relapsed malignant glioma.   "
203842|NCT00509431|"     RATIONALE: Erlotinib and sirolimus may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when     given together with sirolimus and to see how well they work in treating patients with     recurrent malignant glioma.   "
203843|NCT00509444|"     The Centers for Medicare and Medicaid Services (CMS) has awarded cooperative agreements to 6     sites from across the country (Salt Lake City, UT, Molokai, HI, Houston, TX, Newark, NJ,     Detroit, MI, and Baltimore City) to participate in a national 4-year demonstration (September     15, 2006 to September 30, 2010). One goal of the demonstration is to reduce disparities in     cancer treatment among seniors from U.S. racial and ethnic minority populations. Each site     will focus on a specific racial/ethnic minority group, and collaborate with CMS in project     implementation. A Core questionnaire, the Cancer Screening Assessment (CSA) will be     administered at baseline to all participants in the demonstration. Participant     identification, randomization, and intervention implementation will be standardized across     sites.      Goal: The proposal developed by the Johns Hopkins Bloomberg School of Public Health in     collaboration with the Baltimore City Community Health Coalition is designed to address     persistent disparities in breast, cervix, colon/rectum, prostate and lung cancer treatment.      Primary Objective: Conduct A CONTROL RANDOMIZED TRIAL within a randomized control     demonstration project (N = 200) to compare the efficacy of 2 interventions that differ in     intensity to improve continuity and outcomes of care among African Americans seniors. Among     African American seniors, compared to a less intensive intervention (general information and     educational materials), does the addition of facilitation services delivered by a health     coordinator result in a greater improvement in adherence to recommended treatment among those     diagnosed with breast, cervix, colon/rectum, prostate, or lung cancer?      Study Population: We will recruit African Americans, age 65 years or older, and currently     enrolled in Medicare Parts A and B. (Baltimore City's 82,202 seniors represent 13% of its     population, and account for 68% of the City's cancer deaths. Among these seniors, 96% have     Medicare Parts A and B, 54.5% have income levels at less than 250% of the federal poverty     guideline, and 55.6% are African American.)      The trial consists of individuals diagnosed with breast, cervical, colorectal, prostate, or     lung cancer. Eligible participants will respond to a baseline questionnaire, the Cancer     Screening Assessment (CSA). They will then be randomized to receive a less intensive or more     intensive intervention. The less intensive group will receive general information about     cancer and Medicare covered services and instructions to discuss the information with their     primary care doctor. The more intensive group will receive the same information as the less     intensive group receives, plus tailored facilitation services delivered by a nurse-supervised     community health worker. The primary outcome variable for the trial will be the difference     between randomized groups in adherence to treatment for breast, cervix, colon/rectum,     prostate and lung cancer.      A community advisory committee will guide all aspects of the study and will include important     stake holders (both public and private sectors), representatives from the Baltimore City     Community Health Coalition, the Baltimore City Department of Health, the Maryland Department     of Health and Mental Hygiene, community leaders, consumers, health care providers     (physicians, oncologists, nurse practitioners, physician assistants, nurses, social workers,     pathologists) and academicians.   "
203844|NCT00509457|"     To examine the safety and efficacy of telomerase peptide vaccination ( stimulation of the     immune system) in patients with NSCLC after having been treated with conventional therapy     with radiotherapy and docetaxel as a radiosensitizer.   "
203845|NCT00509470|"     The purpose of this study is to compare depressor effect and safety between combination     therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive     patients.   "
203846|NCT00509483|"     Background: Preadministration of recombinant human thyrotropin (rhTSH) increases the amount     and homogeneity of thyroid radioiodine uptake, and when used as an adjuvant can augment the     efficiency of 131I therapy by allowing multinodular goitre (MNG) volume reduction.      Objective: The investigators aimed to assess low-dose rhTSH-aided fixed-activity radioiodine     therapy outcome in MNG patients.      Design: This was a long-term (36 months) observational study. Methods: The investigators     measured 24 h thyroid radioiodine uptake (RAIU) of 1.4 µCi (0.5 MBq) of 131-iodine at     baseline and 24 h after intramuscular injection of 0.1 mg rhTSH in 42 patients (aged 42-80     years) who subsequently received 30 mCi 131-iodine 24 h after an identical rhTSH injection.     Urinary iodine was measured at baseline and at 3 months after following a low iodine diet.     TSH, free thyroxine (FT4), T3 (T3) and thyroglobulin (TG) were measured at baseline, 24 h, 48     h, 72 h, 168 h, one month, 3, 6, 9, 12, 18, 24 and 36 months after therapy. Thyroid volume     was assessed by computer tomography at baseline and every 6 months thereafter.   "
203847|NCT00509496|"     Background:        -  Human peripheral blood lymphocytes have been engineered to express a T-cell receptor          (TCR) that recognizes a blood type, human leukocyte antigen (HLA-A*0201) derived from          the gp100 protein. A retroviral vector was constructed that can deliver the TCR to          cells.        -  This gene-engineered cell is over 10 times more reactive with melanoma cells than is the          melanoma antigen recognized by T-cells (MART-1) TCR that resulted in tumor shrinkage for          two patients with metastatic melanoma.      Objectives:        -  To determine whether an anti-melanoma protein receptor can be put in cells removed from          patients' tumors or blood and then reinfused, with the purpose of shrinking tumors.        -  To evaluate safety and effectiveness of the treatment.      Eligibility:        -  Patients 18 years of age or older with metastatic cancer melanoma (cancer that has          spread beyond the original site).        -  Patient's leukocyte antigen type is HLA-A*0201.      Design:      -Patients undergo the following procedures:        -  Leukapheresis (on two occasions). This is a method of collecting large numbers of white          blood cells. The cells obtained in the first leukapheresis procedure are grown in the          laboratory, and the anti-gp100 protein is inserted into the cells using an inactivated          (harmless) virus in a process called retroviral transduction. Cells collected in the          second leukapheresis procedure are used to evaluate the effectiveness of the study          treatment.        -  Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1          hour for 2 days to suppress the immune system so that the patient's immune cells do not          interfere with the treatment.        -  Treatment with anti-gp100. Patients receive an IV infusion of the treated cells          containing anti-gp100 protein, followed by infusions of a drug called IL-2          (aldesleukin), which helps boost the effectiveness of the treated white cells.        -  Patients are given support medications to prevent complications such as infections.        -  Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue).        -  Patients are evaluated with laboratory tests and imaging tests, such as CT scans, 4 to 6          weeks after treatment and then once a month for 3 to 4 months to determine the response          to treatment.        -  Patients have blood tests at 3, 6, and 12 months and then annually for 5 years.   "
203848|NCT00509509|"     Objectives:        -  To screen population with high risk for breast cancer        -  To promote the concept and importance of surveillance mammography        -  To find out the incidence of breast cancer in population who are in high risk for breast          cancer        -  To collect blood samples for molecular analysis   "
203849|NCT00509535|"     Atopic dermatitis (AD), a chronic and relapsing inflammatory skin disease, is associated with     elevated IgE levels and Th2 responses. It is currently believed that non-pathogenic bacteria     modulate intestinal immune responses avoiding the development of allergic diseases. However,     effects of oral probiotics on AD could not be reproduced in all studies and direct     immuno-modulation of the skin associated immune response by non-pathogenic bacteria has not     been investigated so far. We therefore performed a double blind placebo controlled clinical     study on the effects of an ointment containing 5% extracts of the non-pathogenic bacteria     Vitreoscilla filiformis on AD. Seventy-five AD patients (6-70 years of age) were randomized     to receive either Vitreoscilla filiformis ointment 5% or vehicle ointment daily for 30 days.     Efficacy evaluations, including the Score of Atopic Dermatitis (SCORAD), transepidermal     water loss, assessement of microflora, and the patient assessment of itch and loss of sleep     occurred at baseline, day 15, and day 29.   "
203865|NCT00509743|"     The purpose of this study is to assess the effects of age, weight, and body composition on     the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium     (DIC075V) in adult volunteers.   "
203850|NCT00509548|"     Wet age-related macular degeneration (AMD) is caused by the formation and growth of abnormal     blood vessels (angiogenesis) in the retina. The new blood vessels have fragile walls and can     leak fluid into the retina. The build-up of fluid (edema) under the macula can distort vision     or cause vision loss. TG100801 is a topical (eye drop) therapy that has been shown to inhibit     ocular angiogenesis, vascular leak, and inflammation in laboratory studies. The primary     purpose of this pilot study is to evaluate the ability of topical administration of TG100801     to reduce the amount of fluid in the retina in patients with AMD following 30 days of     treatment. An additional objective is to evaluate the safety of TG100801 in patients with     AMD.   "
203851|NCT00509561|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and capecitabine, work in different     ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays     to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not     yet known whether giving cisplatin together with capecitabine and radiation therapy is more     effective with or without cetuximab in treating esophageal cancer.      PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving     cisplatin together with capecitabine, radiation therapy, and cetuximab works compared with     giving cisplatin, capecitabine, and radiation therapy without cetuximab in treating patients     with esophageal cancer.   "
203852|NCT00509574|"     The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, also known as statins, played     an important role in lipid-lowering therapy and reduction of cardiovascular risks. However,     it has been observed that the response to statin therapy varies from patient to patient, and     gene polymorphism could have contributed to the variation.   "
203853|NCT00509587|"     This phase II trial is studying how well giving pazopanib works in treating patients with     recurrent or metastatic invasive breast cancer. Pazopanib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth and by blocking blood flow to the     tumor.   "
203854|NCT00509600|"     Primary Objectives:      1.1 Estimate rate of response and define acute toxicity to etanercept used in an up-front     phase II window in newly diagnosed or relapsed JMML.      1.2 Determine if response to Tumor Necrosis Factor (TNF) blockade correlates with genetic     basis of Juvenile Myelomonocytic Leukemia (JMML) [mutations in NF1, Ras, SHP2] or levels of     TNFa.      1.3 Determine if TNF blockade by etanercept results in inhibition of free levels of TNFa and     other cytokines by ELISA and bioassay and improves blood counts.      1.4 Estimate the two year event free survival and overall survival in JMML patients following     etanercept and allogeneic hematopoietic stem cell transplantation.   "
203855|NCT00509613|"     The purpose of the trial is to identify the recommended dose of sorafenib and sirolimus for     combination therapy in subsequent phase 2 trials.   "
203856|NCT00509626|"     RATIONALE: Physical activity may prevent or reduce weight gain in women receiving     chemotherapy for early stage breast cancer.      PURPOSE: This randomized phase I/II trial is studying physical activity to see how well it     works compared with usual care to prevent or reduce weight gain in women with stage I or     stage II breast cancer undergoing chemotherapy.   "
203857|NCT00509639|"     The purpose of this study is to compare changes in Perianal Crohn's Disease following use of     locally applied 10% metronidazole ointment and a placebo.   "
203858|NCT00509652|"     Primary hemochromatosis is the most frequent hereditary condition in Scandinavia. The     condition may result in serious organ damage which can be prevented by therapy, but only few     patients develop such organ damage. The optimal treatment, therefore, is still a matter of     discussion Prevention of organ damage has traditionally been accomplished by drawing of full     blood (phlebotomy), which has to be frequently repeated during the initial phase and then     continued indefinitely as a maintenance treatment. The removed amount of iron may be     increased two- or threefold for each procedure by using modern equipment for selective     removal of red blood cells (red cell apheresis). Possible drawbacks of this technique may be     higher costs, prolonged time for each therapeutic procedure, and certain requirements to the     patients. The possible advantages are the reduced number of therapeutic procedures and less     strain for the patient. No larger, randomized study has been published in order to determine     which method should be preferred.      This study is a controlled trial in which participating patients are asked to be randomized     to red cell apheresis or traditional phlebotomy. Each group will be followed by means of     well-defined assessments in order to explore possible advantages and disadvantages of each     method in order to establish what type of treatment should be recommended.   "
203859|NCT00509665|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with     doxorubicin works in treating patients with recurrent or progressive head and neck cancer.   "
203860|NCT00509678|"     The purpose of this study is to help determine the effectiveness of rituxan (with or without     methotrexate) in the treatment of psoriatic arthritis.   "
203861|NCT00509691|"     RATIONALE: Vaccines may help the body build an effective immune response to kill     cytomegalovirus infections.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients who have undergone a donor stem cell transplant and have cytomegalovirus     infection that has not responded to therapy.   "
203862|NCT00509704|"     The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and     necrosis in patients with metastatic renal cell cancer.   "
203863|NCT00509717|"     The purpose of this study is to determine the effectiveness of maximal support of community     pharmacies to implement a pharmaceutical care model for improving underprescription and     treatment persistence regarding lipid-lowering medication in patients with cardiovascular     disease.   "
203864|NCT00509730|"     To test the value of preoperatively performed urodynamics with regard to outcome of surgery     for stress urinary incontinence (SUI) and to examine whether not performing urodynamics     preoperatively is more cost effective than performing urodynamics preoperatively using the     non-inferiority assumption.   "
203868|NCT00509782|"     Primary Objectives:        1. To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when          administered intravenously once a day for 5 consecutive days every 4 weeks in subjects          with advanced solid tumors.        2. To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once          a day for 5 consecutive days every 4 weeks.      Secondary Objective:      1. To determine the anti-tumor effects of ZIO-101.   "
203869|NCT00509795|"     This study is a phase 3, double-masked, randomized, study of the efficacy and safety of VEGF     Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200     patients will be randomized in the US and Canada.   "
203870|NCT00509808|"     This is a multinational trial, aimed at testing the safety and performance of a     electrostimulating device (GenNarino) to treat dry mouth, over one year. The design is as     follows:        -  Multi-center, double blind, sham (placebo) controlled, about 10 xerostomia patients per          center        -  Patients receive a GenNarino (and its remote control) that is programmed for one month          sham and one month active mode (the order of which is randomly assigned), and thereafter          9 months at the active mode (divided in period of 3 months, the order of each is          randomly assigned at wearing GenNarino for 1, 5 or 10 minutes at a time).      Study hypothesis: Gennarino will lead to significant symptomatic improvement      - At the clinic: monthly examinations at the first 2 months, and then every 3 months,     including whole saliva collection and questionnaire; at the first visit impression taking for     GenNarino preparation   "
203871|NCT00509821|"     The purpose of the protocol is to induce a novel radiochemotherapy with enzastaurin as     first-line treatment regimen in glioblastoma: Patients with active, unmethylated MGMT     promoter will be treated with enzastaurin before, concomitant, and after radiotherapy to     determine safety and PFS at 6 months (PFS-6) in phase II.   "
203872|NCT00509834|"     This is a phase-I, double-blind, randomized study with hLF1-11 to study the tolerability and     early efficacy of hLF1-11 compared to standard fluconazole therapy in hospitalized patients     with invasive Candida infection.   "
203873|NCT00509847|"     The purpose of this study is to establish the tolerability of treatment with human     lactoferrin 1-11 peptide (hLF1-11) administered intravenously as a single dose given for 10     consecutive days, to patients with bacteremia due to staphylococcus epidermidis.   "
203874|NCT00509860|"     Primary Objectives:        1. To determine the efficacy of the topoisomerase I (topo I) inhibitor irinotecan,          delivered via a low-dose protracted schedule to patients with advanced sarcoma.        2. To determine the toxicity profile of irinotecan, using a protracted schedule, in this          pretreated patient population.   "
203875|NCT00509873|"     The study will determine the safety and efficacy of gatifloxacin eye drops in patients with     bacterial conjunctivitis   "
203876|NCT00509886|"     The purpose of this study is to assess the effectiveness of the prescription treatment     compared to the non-prescription treatment. It is hypothesized that the prescription     treatment will have a significantly greater effect than the non-prescription treatment on     decreasing excess sweating.   "
203877|NCT00509899|"     To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424),     administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera     Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).   "
203878|NCT00509925|"     This trial is conducted in Europe. The purpose of this trial is to investigate if there is     any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in     patients with type 1 diabetes, whilst taking two different, commercially available insulins     for the treatment of their diabetes.   "
203879|NCT00509938|"     The safety and tolerability of hLF 1-11 has to be established first in HSCT recipients who     are at risk of developing, but have not yet developed, infectious complications due to     invasive fungal disease. These patients are different from healthy volunteers because they     have received myeloablative treatment which not only arrests haematopoiesis resulting in     neutropenia but also induces mucosal barrier injury both of which predispose to infections     which typically occur during the week after transplant. It is therefore essential to know     that hLF 1-11 is when given during neutropenia and mucosal barrier injury before infections     ensue   "
203880|NCT00509951|"     This study will compare the effectiveness of two types of cognitive behavioral therapy,     one-session exposure treatment and family-enhanced one-session exposure treatment, in     treating children with specific phobias.   "
203881|NCT00509964|"     Patients with recurrent or metastatic gastric cancer can benefit from palliative     chemotherapy. However, over half of patients with metastatic gastric cancer who received     chemotherapy failed to achieve response and even in these responders, the duration of     responses was as short as a few months. Patients with metastatic gastric cancer who fail to     respond or have relapse after first line chemotherapy have a grim prognosis and a standard     salvage treatment is not available.      We designed this phase II trial to determine the efficacy and safety of irinotecan     monotherapy or combination (ILF) as second-line therapy for advanced gastric cancer.   "
203882|NCT00509977|"     The purpose of this study is to determine the efficacy of light treatment and laser treatment     for melasma. These treatment options have not been thoroughly explored in the treatment of     melasma. By studying the effect of different treatments, a better treatment plan may be     developed for people with melasma.   "
203883|NCT00509990|"     An open-label, multicenter study, of long term management to evaluate effectiveness,     tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate     atopic dermatitis in a daily practice   "
203884|NCT00510003|"     The purpose of this study is to assess the efficacy and safety of pimecrolimus cream 1% in     relation to the improvement of pruritus in pediatric patients (2- to 11- year-old) with mild     to moderate atopic dermatitis.   "
203885|NCT00510016|"     To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will     be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal)     than tincture of opium (DTO) alone.   "
203886|NCT00510029|"     The study will assess the safety, tolerability and pharmacokinetics of single intravenous     (IV) doses of GAP-134 in healthy subjects. GAP-134 will be administered as a 24-hour     infusion.   "
203908|NCT00516477|"     The purpose of this study is to determine whether gene transfer will be safe and effective in     the treatment of Leber Congenital Amaurosis (LCA).   "
203887|NCT00510042|"     The objective of this study is to assess the clinical presentation, the treatment and the     complications of the disease and treatment in moderate and severe von Willebrand disease.     Another goal is to investigate the influence of von Willebrand disease on quality of life.   "
203888|NCT00510055|"     The primary objective of this study is to look at the efficacy of subdermal manipulation and     filler injection in the improvement of acne scar appearance.   "
203889|NCT00510068|"     The purpose of this study was to evaluate progression free survival in those participants     assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus     Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.   "
203890|NCT00510081|"     The objective of this study is to determine the effectiveness of a filler in improving     wrinkles.   "
203891|NCT00510094|"     This study will evaluate the effectiveness of a school-based social cognitive group treatment     in reducing aggression (bullying) among relationally aggressive urban African American girls.   "
203892|NCT00510107|"     To evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin     and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. The     primary endpoint will be the response rate.   "
203893|NCT00510120|"     This study will evaluate the effectiveness of two different psychosocial therapies, parent     management training and collaborative problem solving, in treating children with     oppositional-defiant disorder.   "
203894|NCT00516295|"     This phase II trial study has a 6-patient feasibility portion studying the tolerability of     chemotherapy with vincristine sulfate together with topotecan hydrochloride,     cyclophosphamide, and bevacizumab in treating young patients with refractory or first     recurrent extracranial Ewing's sarcoma. If the therapy is considered tolerable, this     feasibility run-in will be followed by a randomized phase II portion studying giving     vincristine sulfate together with topotecan hydrochloride, and cyclophosphamide to see how     well it works compared with giving vincristine sulfate together with topotecan hydrochloride,     cyclophosphamide, and bevacizumab in treating young patients with refractory or first     recurrent extracranial Ewing's sarcoma. Drugs used in chemotherapy, such as vincristine     sulfate, topotecan hydrochloride, and cyclophosphamide, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Bevacizumab may also stop tumor growth by     blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab     may kill more tumor cells.   "
203895|NCT00516308|"     To assess the proximity of the catheter to the vessel wall and to correlate excised tissue     with images collected by the integrated Optical coherence Tomography (OCT) imaging system.     The primary endpoints are correlation between OCT images and histological characterization of     excised tissue.   "
203896|NCT00516321|"     The purpose of this study is to assess the ability of eltrombopag to maintain a platelet     count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy     dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical     benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve     a Sustained Virological Response (SVR).   "
203897|NCT00516334|"     This study is evaluating whether a bedside brainwave monitor can be used to detect early     brain injury in premature infants.   "
203898|NCT00516347|"     RATIONALE: Learning about how often heartburn and other risk factors occur in brothers and     sisters and other family members of patients with Barrett's esophagus may help identify other     individuals at risk and identify genes for Barrett's esophagus.      PURPOSE: This clinical trial is studying genes for Barrett's esophagus in brothers and     sisters.   "
203899|NCT00516360|"     The purpose of this study is to prevent catheter-related infections in newborn infants     admitted to the Neonatal Intensive Care Unit (NICU). This study will compare the     effectiveness of daily chlorhexidine versus isopropyl alcohol in preventing the growth of     microbes in catheters.   "
203900|NCT00516373|"     To determine the safety, tolerability, dose-limiting toxicity (DLT),     pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when     administered orally to patients with advanced solid tumours. To further evaluate the safety     and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily     ovarian cancer patients.   "
203901|NCT00516386|"     The purpose of this study was to determine whether giving insulin like growth factor-I     (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone     formation markers.   "
203902|NCT00516399|"     The purpose of this study is to determine the effectiveness of 1.25% povidone-iodine     ophthalmic solution for the treatment of small to medium sized fungal corneal ulcers compared     with an antifungal antibiotic.   "
203903|NCT00516412|"     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with     relapsed or refractory mantle cell lymphoma.   "
203904|NCT00516425|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, epirubicin, and cyclophosphamide,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor     cells that remain after surgery. Sometimes, after surgery, the tumor may not need more     treatment until it progresses. In this case, observation may be sufficient. It is not yet     known whether giving doxorubicin or epirubicin together with cyclophosphamide is more     effective than observation in treating older women with invasive breast cancer.      PURPOSE: This randomized phase III trial is studying doxorubicin or epirubicin and     cyclophosphamide to see how well they work compared with observation in treating older women     with invasive breast cancer.   "
203905|NCT00516438|"     The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436     that can be given in combination with topotecan chemotherapy in patients with advanced solid     tumours   "
203906|NCT00516451|"     The purpose of this clinical study is to identify the maximum tolerated dose (MTD) of     BMS-690514 once daily orally in Japanese subjects with advanced or metastatic solid tumors.   "
203909|NCT00516490|"     A single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles     was reported to increase pregnancy and birth rates. This study was done to evaluate the     reproducibility of previous findings.   "
203910|NCT00516503|"     RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused     by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in     treating peripheral neuropathy caused by chemotherapy .      PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works     compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients     with cancer.   "
203911|NCT00516516|"     Muscle cramps occur frequently among pregnant women, and few therapeutic options exist. This     is a study of oral L-carnitine, a dietary supplement, for the treatment of muscle cramps in     pregnancy. Our hypothesis is that carnitine will alleviate or eliminate muscle cramps     experienced by pregnant women.   "
203912|NCT00516542|"     RATIONALE: Androgens can cause the growth of breast cancer cells. Hormone therapy using     dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the     tumor cells. Letrozole may stop the adrenal glands from making androgens. Giving DHEA     together with letrozole may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of DHEA when given     together with letrozole in treating patients with metastatic breast cancer.   "
203913|NCT00516555|"     The purpose of this study is to evaluate whether successful external cephalic version is     associated with maternal thyroid function and mood state in pregnant women with breech     presentation at term.      The relationship between successful external cephalic version and neonatal thyroid function     will also be investigated.      A possible beneficial effect of successful external cephalic version on the development of     congenital hip dysplasia will be evaluated.   "
203914|NCT00516581|"     From the beginning of the AIDS epidemic, pulmonary pneumocystosis (PCP) has been     distinguished as one of the most frequent opportunistic diseases with high morbid-mortality.     As from 1996, the advent of the highly active antiretroviral therapy (HAART) has changed the     characteristics of such epidemic by reducing its related diseases and, as a result,     AIDS-related mortality. With the purpose to estimate PCP occurrence and HAART interference,     376 HIV-infected or AIDS patients were studied from January 1992 to December 2002.   "
203915|NCT00516594|"     Our antibiotic studies indicated that cholesterol lowering was seen when fecal     bifidobacterial counts were increased. Due to the dangers associated with prolonged     antibiotic use we have been funded by the Heart and Stroke Foundation to see if gut bacteria     can be modified by non-antibiotic means. Inulin a dietary fiber found in artichokes, chicory,     leaks, onion, etc., (which also produces flatulence) has been shown to increase     bifidobacteria and also appears to lower serum cholesterol. We will therefore test the fiber     to determine its effectiveness in lowering serum cholesterol and whether it can be used to     maximize the cholesterol-lowering effects of soy protein foods and viscous fiber foods (e.g.     oats and psyllium).   "
203916|NCT00516607|"     RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as temozolomide, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving enzastaurin together with     temozolomide may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin when     given together with temozolomide in treating patients with primary gliomas.   "
203917|NCT00516620|"     The aim of this study is to see if the investigators can encourage people to eat more fruits,     vegetables and whole grains and drink less pop by giving them advice about their diet, or by     providing them with samples of different kinds of foods. The investigators are interested in     the effect this has on reducing the risk of chronic disease. The investigators will also be     investigating how certain genes affect the choices people make about the foods they eat.   "
203918|NCT00516633|"     We wanted to investigate if it was possible to improve adherence to prescriptions and advice     in pre-school children with newly diagnosed asthma. The intervention was intense information     and support in the form of four group discussions with the parents of four children in close     connection to diagnosing the child. The control children received the usual care with     individual polyclinic visits to the physi-cian/nurse. We evaluated the effect with the help     of questionnaires, physical examinations, blood tests, lung function tests and control of     treatment adherence after 18 months and 6 years.   "
203919|NCT00516646|"     Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a     role in the development and progression of heart failure. The AGE-crosslink breaker     Alagebrium (ALT-711) improved cardiac function and symptoms in experimental and small human     heart failure studies. These results have not yet been confirmed in a randomized controlled     clinical trial.   "
203920|NCT00517699|"     This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus     high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible     patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus     methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week     11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample     size is <100 individuals.   "
203934|NCT00517881|"     This single arm study will assess the efficacy, safety and tolerability of subcutaneous     methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in     pre-dialysis participants with chronic renal anemia. Participants currently receiving     maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous     injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived     from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.   "
203935|NCT00517894|"     To investigate if a dose-dense chemotherapy with weekly chemotherapy compared to standard     treatment every 3 weeks results in better survival in aggressive non-Hodgkin's lymphoma.   "
204028|NCT00519116|"     The study evaluated renal graft function (based on the calculated creatinine clearance) 6     months after kidney transplantation in patients receiving either a regimen of 'reduced-dose'     tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus +     sirolimus + corticosteroids.   "
207173|NCT00561990|"     CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER   "
203921|NCT00517712|"     There is very limited data on the use of arsenic trioxide in newly diagnosed patients with     acute promyelocytic leukemia. The use of arsenic trioxide was limited to relapsed patients     mainly because of the superior efficacy of ATRA as primary therapy for newly diagnosed APML.     Though the early study by Niu et al showed 72% remission rates in 11 newly diagnosed     patients, the role of arsenic trioxide as primary therapy was limited by the hepatic toxicity     seen in this study. Studies from our centre have shown remission rates of 70-75% in newly     diagnosed patients with acute promyelocytic leukemia. There was no major toxicity seen     related to the administration of arsenic trioxide. Follow up data on these patients continue     to show long term remission rates above 70%. These remission rates are similar to the data     available in patients with acute promyelocytic leukemia treated with ATRA. Lu et al studied     19 patients treated with oral arsenic (Tetra-arsenic tetra-sulfide) wherein 84% achieved     hematological remission with disease free survival of 76% at 3 years. Studies from other     groups using arsenic trioxide alone or in combination with ATRA have shown similar remission     rates. Arsenic trioxide as primary therapy for patients with newly diagnosed acute     promyelocytic leukemia is a very attractive treatment option for developing countries mainly     because of the low cost involved along with the favorable toxicity profile. However long term     remission data is still not available and the ideal course and duration of treatment still     needs to be defined. This multi-center study aims to further clarify the efficacy of this     agent in the treatment of newly diagnosed cases of acute promyelocytic leukemia and to study     the optimal maintenance regimen.   "
203922|NCT00517725|"     The investigators test the hypothesis that different beta-blockers had a different influence     on chemoreceptor response and lung diffusion capacity.      Both could influence exercise capacity in normoxic as well as hypoxic conditions.   "
203923|NCT00517738|"     Physical training improves quality of life (QOL) in non-hepatic diseases. It is possible that     the same effect happens in patients with cirrhosis and portal hypertension. Hepatic     encephalopathy may also benefit from physical activity by increasing ammonia metabolism. The     intention of this study is to assess if patients can improve their QOL and hepatic     encephalopathy during a physical training program, and to address its safety.   "
203924|NCT00517751|"     This prospective, multicenter longitudinal five-year study of X-STOP PEEK usage in LSS     patients is designed to supplement pre-market safety and effectiveness data with information     on longer-term device performance in a population of patients with moderately impaired     physical function at preoperative baseline (i.e., an indicated population) who elect to     undergo X STOP PEEK surgery.   "
203925|NCT00517764|"     The Blue Sky Project, a 5-year study funded by the Canadian Institutes of Health Research,     seeks to examine how genetics and early life experiences work together to cause a person's     very first onset of depression by increasing sensitivity to stress.   "
203926|NCT00517777|"     To assess in moderate to severe Obstructive Sleep Apnea the effects of one year therapy with     nighttime continuous positive airway pressure ventilation on the prevalence of metabolic     syndrome and cardiovascular damage.   "
203927|NCT00517790|"     The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.   "
203928|NCT00517803|"     We hypothesize that micronutrient fortified probiotic yogurt can improve nutritional status     and enhance immunity parameters in subjects HIV/AIDS and other immunodeficiencies.      We have developed a micronutrient-fortified probiotic yogurt that has safe and beneficial     levels of micronutrients for human consumption. This has been undertaken with the guidance of     Edward Farnworth, a senior research scientist at Agri-Food Canada-Food Research and     Development Centre, St. Hyacinthe, Quebec      We will now measure nutritional parameters (height, weight, serum albumin, serum nutrient     levels, blood urea, liver function tests (AST, ALT)) to determine if there is a statistically     significant difference between the various levels of fortified probiotic yogurt and the     placebo on the nutritional parameters of the subjects consuming the yogurt.      We will measure immunological parameters (CD4 lymphocyte count, CBC, levels of TNFα, IL-12,     IL-10, and G-CSF [Kim, et.al. 2006]) in order to determine if there is a statistically     significant difference using fortified probiotic yogurt compared to a placebo.      In addition, we will determine if the micronutrient-fortified probiotic yogurt has a     significant impact on the overall quality of life for the subjects using the linear analogue     self assessment tool [Kaiser, et.al 2006].   "
203929|NCT00517816|"     This 8 arm study will evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of single ascending doses of R1671 or placebo in patients with mild,     intermittent, asymptomatic asthma. Patients will be randomized to receive placebo or R1671,     at a starting dose of 0.0015mg, by intravenous infusion; this dose will be escalated in     subsequent groups of patients after a satisfactory assessment of the data from the previous     dose. The anticipated time on study treatment is <3 months, and the target sample size is     <100 individuals.   "
203930|NCT00517829|"     The purpose of this research study is to find out what effects (good and bad) docetaxel,     oxaliplatin, and cetuximab have on gastric or GEJ cancer.   "
203931|NCT00517842|"     The investigational product is a specially formulated TCM and administered in the form of a     capsule.      Basic pre-clinical studies have suggested that it may have good immunomodulating functions,     increases the activities of T-cells, B-cells and NK cells, enhances mitochondrial antioxidant     status on various tissues including brain tissues. Therefore, this formulation may have     special values in improving symptoms in Parkinson's disease patients.      The purpose of the study is to determine the efficacy and safety of ViNeuro in patients with     Parkinson's disease.   "
203932|NCT00517855|"     This study is the second human clinical study with PRTX-100. It is designed to assess the     safety of a single intravenous (IV) dose of PRTX-100, as well as, how the drug is eliminated     from the blood after dosing. Additionally, this study provides an opportunity to monitor     immune system response to PRTX-100.   "
203933|NCT00517868|"     A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary     frequency following administration of URG101 compared to placebo.   "
204008|NCT00518856|"     We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training     traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP)     and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.   "
204715|NCT00521040|"     Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen     Season in Subjects With SAR   "
203936|NCT00517907|"     The primary goal of this study is to determine the safety and tolerability of a novel peptide     - preimplantation factor (PIF-1) - in patients who develop acute steroid-resistant     graft-versus-host disease (GVHD) after matched bone marrow transplant (BMT).      Following matched BMT, patients will be placed on standard GVHD preventive therapy     (cyclosporine); those who do not respond to cyclosporine are placed on a high-dose steroid     regimen for 3 days. Patients that do not respond to this standard treatment will be given     PIF-1 subcutaneously for 14 days.      Clinical data and samples will be collected, during PIF-1 administration and for an     additional three months thereafter, to examine the long-term effect of PIF-1 treatment on the     patients' GVHD status.   "
203937|NCT00517920|"     Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)   "
203938|NCT00517933|"     Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's     ability to breathe. This study will evaluate the effectiveness of sildenafil, a medication     that increases blood flow to the lungs, at improving breathing function, exercise capacity,     and quality of life in people with advanced IPF.   "
203939|NCT00517946|"     The purpose of this study is to establish whether MRI scanning is a sensitive measure of the     effects of existing drug treatments on nasal dimensions following challenge with intranasal     allergen in subjects with hayfever. If successful this technique could be applied to increase     confidence for internal decision making and ultimately may be used to assess how effective a     new drug treatment is.   "
203940|NCT00517959|"     Brain tumours are the commonest solid tumours in children and the second most common     neoplasms overall in this patient population. Radiotherapy plays an important part in the     management in a majority of these tumours. While the cure rates of these tumours, especially     the benign and low grade ones are quite encouraging, the treatment itself may lead to some     late sequelae, which could have significant implications in the quality of life in these     long-term survivors.      Stereotactic conformal radiotherapy (SCRT) is a modern high-precision radiotherapy technique,     which reduces the volume of normal brain irradiated and has the capability to minimise the     doses to critical structures. The present study is designed to prospectively estimate the     incidence and severity of neuropsychological, cognitive and neuroendocrine dysfunction     following radiotherapy delivered with conventional and stereotactic techniques and would be     one of the most comprehensive studies providing very important longitudinal and reliable data     regarding these sequelae. The study involving 200 patients would be to the best of our     knowledge not only the largest ever study conducted so far but also the only randomised trial     assessing these sequelae in patients receiving focal brain irradiation.      The study also examines whether the physical advantages of modern technological progress     translate in clinical benefit. This could have significant implications in the     radiotherapeutic management of children and young adults with brain tumours. The study is     unique in design in terms of evaluating the efficacy of SCRT with respect to conventional     radiotherapy in terms of long term tumour control and treatment related complications.   "
203941|NCT00517972|"     Recently, antidepressants and other similar acting agents have been explored as a class of     medications to treat major depressive disorder (MDD) in the context of perimenopause, as well     as the somatic symptoms of perimenopause (such as hot flashes). Omega-3 fatty acids, which     include eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are nutritional compounds     with widely established health benefits and which occur naturally in fish and marine sources.     Results of previous mood disorder studies have indicated that omega-3 fatty acids may be of     help in the treatment of depression. Therefore, the current study is designed to examine the     effectiveness and tolerability of the study drug, Omacor, (omega-3 fatty acid ethyl esters),     in the treatment of major depressive disorder in perimenopausal women.   "
203942|NCT00517985|"     Recently, antidepressants have been explored as a class of medications to treat major     depression in the context of perimenopause, as well as the somatic symptoms of perimenopause     (such as hot flashes). Duloxetine (Cymbalta) is one of the newer antidepressants approved for     the treatment of Major Depressive Disorder (MDD). Therefore, the current study is designed to     assess the efficacy of duloxetine in a sample of women who are perimenopausal and meet     criteria for MDD. We will assess impact on MDD and perimenopausal symptoms.   "
203943|NCT00517998|"     The purpose of this study is to evaluate the safety and efficacy of the Biologic Lung Volume     Reduction System (BLVR) for patients with advanced emphysema refractory to medical therapy.   "
203944|NCT00518011|"     This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared     with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced     non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po     daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine     monotherapy. The anticipated time on study treatment is until disease progression, and the     target sample size is 100-500 individuals.   "
203945|NCT00518024|"     Tinnitus, i.e., the perception of sounds or noise in the absence of auditory stimuli, is a     frequent and often severely disabling symptom of different disorders of the auditory system.     There are currently no causal treatments. Using repetitive transcranial magnetic stimulation     (rTMS), we have previously demonstrated that the temporoparietal cortex is critically     involved in tinnitus perception and that tinnitus can be reduced by rTMS applied to these     cortical regions. Therefore, it is reasonable to test rTMS as a potential new treatment     strategy against tinnitus. At this stage, small pilot studies indicate some effect on     tinnitus impairment but the reduction is predominantly reported to be transient, with high     interindividual variability, and questionable clinical relevance. Moreover, the optimal     stimulation area is unclear.      Here, we use theta burst stimulation (TBS), a new rTMS paradigm for the prolonged modulation     of cortical activity. The aim of this study is to test safety and effectivity of 4 weeks of     daily bilateral TBS to two cortical areas on chronic tinnitus compared to sham-stimulation.   "
203946|NCT00518037|"     The goal of this study is to learn more about the physical discomfort, sensory impairment,     depression, anxiety, and interference with relationships, family, and work associated with     NMSC via survey questions.   "
203947|NCT00518050|"     The purpose of this study is to examine the health behaviors of melanoma survivors. We want     to know about their thoughts and concerns. Melanoma is a type of skin cancer. The number of     people being diagnosed with melanoma is growing. Many people who are diagnosed with melanoma     are young. Little research has been done to find out how melanoma survivors feel years after     they have been treated.   "
203948|NCT00518076|"     The Staphylococcus aureus is an important pathogen bacteria actuating as an agent of a wide     variety of infections, such as the superficials to the disseminates ones, its commonly find     into hospitals ambient, assailing mainly immunosupress patients. Around 30% to 50% of people     carries this agent in their nasal bone as part of their normal flora, occuring larger in     hospitals workers. The S. aureus is also known for its high capacity of developing resistance     to various antibiotic. Facing these considerations, the importance of nursing precaution and     the infections control inside hospitals ambient, the purpose of this present study aimed to     verify the rates of carriers of S. aureus in nursing students and the connection with the     hospitals time involvement during graduation in the Faculty de Medicine de Botucatu - UNESP,     embracing the 4 years of graduation college.   "
203949|NCT00518089|"     The study will determine the safety and efficacy of gatifloxacin eye drops in patients with     bacterial conjunctivitis   "
203950|NCT00518102|"     The purpose of this study is to compare the risk of cancers in patients who have used     REGRANEX (becaplermin) to that of patients with similar characteristics and health issues who     have not used REGRANEX (becaplermin). REGRANEX (becaplermin) is topical medication used to     treat non-healing neuropathic foot ulcers in patients with diabetes.   "
203951|NCT00518115|"     This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are     either taking no diabetes medication or who are taking metformin only. This study will     investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will     measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16     weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide     (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up     visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring     of any side effects.   "
203952|NCT00518128|"     The goal of this research is to improve our understanding of the effectiveness of surgical     OSA treatment by evaluating its impact on these health-related and functional outcomes and     comparing these effects to the changes in respiratory physiology achieved after surgery. To     achieve this goal, we will examine key health-related (C-reactive protein, homocysteine,     leptin, the homeostasis model of insulin resistance, and heart rate variability) and     functional (sleep-related quality of life and vigilance) measures among a surgical group of     OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a     comparison group of matched OSA patients who tolerate PAP.   "
203953|NCT00518141|"     This study aims to determine the possible effects of Acetyl Salicylic Acid (ASA) and     Terbutalin on ART treatment.   "
203954|NCT00518154|"     The purpose of this study is to determine whether the addition of Pyridostigmine to Highly     Active Antiretroviral Therapy (HAART) increases the number of CD4+ T-cells in discordant     patients in which viral load diminishes, but T-cell levels remain low after the initiation of     treatment.   "
203955|NCT00518167|"     The aim of this study is to clarify whether lifestyle intervention provided to people with     high type 2 diabetes risk will lower the cumulative incidence of diabetes. Furthermore, the     aim is to study the effect of lifestyle intervention on cardiovascular risk.   "
203956|NCT00518180|"     This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY     conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents   "
203957|NCT00518193|"     The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association     cisplatine - topotecan .      News thérapeutics are needed in the goal of increase the survival and quality of life in     patients with cervix cancer.      Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.      Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate.     Many clinical trials shown the faisability of the association of cetuximab and cisplatine in     cancer.      Many clinical trials have shown the faisability of association of cetuximab and irinotecan in     colorectals metastatiques cancers .   "
203958|NCT00518206|"     This was a Phase 2, open-label study of the NY-ESO-1 ISCOMATRIX® (ISCOM) vaccine administered     as an intramuscular injection given every 4 weeks to subjects with measurable advanced     malignant melanoma. Study objectives included determination of the anticancer activity,     cellular and humoral immunogenicity, and safety and tolerability of the NY-ESO-1 ISCOM     vaccine administered alone or preceded by a single administration of low-dose     cyclophosphamide.   "
203959|NCT00518219|"     The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment     of heavy proteinuria of membranous nephropathy.   "
203960|NCT00518232|"     The purpose of the study is to investigate the clinical benefit of switching children with     ADHD from immediate-release methylphenidate (IR-MPH) to OROS-methylphenidate under the     correct dosage conversion scheme.   "
203961|NCT00518245|"     The purpose of this study is to determine whether enoxaparin (an anticoagulant) is effective     in the treatment of patients presenting to the emergency room with chest pain and no     electrocardiogram or bloodwork evidence of a heart attack, but with other high risk clinical     features   "
203962|NCT00518258|"     The purpose of this study is to investigate similarities and differences in the neural     pathways of depressed Parkinson's patients, non-depressed Parkinson's patients, and healthy     controls using magnetic resonance imaging (MRI) of the brain and neuropsychological     assessment.   "
203963|NCT00518271|"     This study evaluated renal graft function based on calculated creatinine clearance at 6     months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose     tacrolimus plus sirolimus and corticosteroids.   "
203964|NCT00518284|"     The purpose of this study is to investigate the prevention of Restenosis following     Revascularization of the superficial Femoral Artery (SFA)   "
203965|NCT00518297|"     The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of     raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300     mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without     raltegravir 400 mg BID.   "
204027|NCT00519103|"     The aim of this study was to investigate the effects of physical exercise on gene expression     in muscle biopsies from patients with chronic polymyositis or dermatomyositis   "
204163|NCT00513656|"     The purpose of this study is to test the oxycodone/naloxone combination compared to oxycodone     alone in patient's specific type of chronic cancer pain.   "
203966|NCT00518310|"     Idiopathic pulmonary fibrosis (IPF) is a diffuse lung disease, associated with the     histological appearance of usual interstitial pneumonia (UIP), with an inexorably     deteriorating clinical course. Prognosis is poor, reported median survival is less than 3     years. The prevalence is estimated as being 3 to 10 per 100.000 in different Western     populations. To date, no pharmacological therapy has been proven to alter or reverse the     pathogenic process of IPF. Most treatments trials have been observational case series of     small patient populations and very few have been randomized, prospective and     placebo-controlled.      Two recent Cochrane reviews investigated the role of corticosteroids and other     immunomodulatory agents and concluded that there is no evidence for their use in IPF. Most     current therapies are targeted to suppress the inflammatory component of the disease, based     on the theory that it would be chronic alveolar inflammation which leads to parenchymal     remodeling and fibrosis. Recently, a hypothesis that has gained acceptance suggests that     fibrosis may result directly from alveolar injury, promoting an abnormal fibrogenic repair     mediated by fibroblasts and myofibroblasts.      One of the cytotoxic agents most widely used and better tolerated in the management of IPF is     azathioprine. Based upon limited data available and from a single small high quality     randomized controlled trial (RCT), this drug appears to confer, given in conjunction with     prednisone, a marginal long term survival advantage. Since this combination therapy is     associated serious adverse effect, we planned to design a trial of low dose corticosteroid     and azathioprine versus placebo in management of IPF, evaluating progression-free survival.      Our study hypothesis is: Combined therapy with azathioprine and corticosteroids improves     progression-free survival in patients with the diagnosis of IPF.   "
203967|NCT00518323|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of 3     weight-based, fixed-dose groups of paliperidone extended release (ER) compared with placebo     in adolescent patients between 12 to 17 years of age, who are diagnosed with schizophrenia.     Paliperidone ER is an atypical antipsychotic agent approved by the U.S. Food and Drug     Administration for the treatment of schizophrenia in adults. Patients may be voluntary     inpatients or outpatients at the time of the screening visit, but should have returned to     their usual living situation by Day 21 of the double-blind treatment phase. The study     duration is approximately 10 weeks. Patients who have completed this study or who were     discontinued from this study due to lack of efficacy but have completed at least 21 days of     double-blind treatment and are expected to benefit from paliperidone treatment, may enter an     optional open-label safety study.   "
203968|NCT00518336|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy,     safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of     women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having     participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in     the primary & follow-up study will be enrolled in this long-term follow-up study. Subjects     were aged 15-25 years at the time of entry into the primary study.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
203969|NCT00518349|"     A prototype colonoscope with an extra passively bending distal section has been developed by     Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of     this function.   "
203970|NCT00518362|"     The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus     Valsartan (ARB) in the Diabetic Nephropathy (DN).   "
203971|NCT00518375|"     This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months     after transplantation in patients receiving either a regimen of reduced dose or standard dose     cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft     rejection at 6 and 12 months following transplantation and patient and graft survival at 12     months were evaluated also.   "
203972|NCT00518388|"     The goal of this research study is to learn about the beliefs, practices, and knowledge about     cervical cancer among Asian American young adults. Researchers want to develop materials that     will educate Asian Americans about cervical cancer and encourage them to get screened for     this disease.   "
203973|NCT00518401|"     The purpose of this research study is to determine if the transplant of a combination of stem     cells obtained from the bone marrow of the same patient will contribute to the formation of     new blood vessels in the severely diseased ischemic limb (leg). In this study the safe use of     this combination of stem cells and its effects on making new blood vessels will be evaluated.      Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decreases blood     flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain     and even skin ulcers or sores.      LI needs comprehensive treatment since the condition will not improve on its own. The overall     goal of treatment is to reduce the pain and increase blood flow to improve symptoms or save     the leg or feet. In many cases, current options for treatment including medications, surgery     or endovascular procedures have not been successful.      In the last few years, investigators have explored therapies aimed to increase blood flow to     the ischemic vessels by transplanting cells that will promote the development of new vessels     in the diseased leg.      The study hypothesis is based on the concept that the process of formation of new blood     vessels is complex and requires the participation of several types of stem cells and growth     factors. The lack of any of these components will produce vessels which are immature and     unable to provide appropriate blood supply to the leg.      Patients eligible to participate in this study are those suffering from poor circulation or     severe leg blockages, which are not candidates for surgical procedures.      Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will     be transplanted into the calf muscle of the diseased leg. Clinical studies to evaluate if the     transplant works and is safe will be performed up to 1 year after cell transplant.   "
203974|NCT00518414|"     Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.   "
203975|NCT00518427|"     Primary objective:      To assess quality of Life (QoL) changes and treatment satisfaction in a real life situation     in patients with Type 2 diabetes inadequately controlled on a combination of oral     antidiabetic drugs (OAD) plus Neutral Protamine Hagedrone (NHP) insulin treatment that are     switched to insulin glargine.      Secondary objective:      To determine:      change in HbA1c, comparision of the incidence of symptomatic hypoglycemia and severe     hypoglycemia before and after introduction of insulin glargine, change in weight, change in     insulin dose.   "
203976|NCT00518440|"     The purpose of this study is to collect clinical and epidemiological data as well as serum,     plasma, urine, tissue and DNA samples on individuals who have acute liver failure and on     individuals who have acute liver injury, a less severe group of patients who have     coagulopathy but do not reach the threshold of encephalopathy.   "
203977|NCT00518453|"     Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines     are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and     tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical     trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).   "
203978|NCT00518466|"     The primary objective of this study is to describe the single- and multiple-dose     pharmacokinetic profiles of two novel formulations of topiramate and commercially available     immediate release topiramate, all dosed with immediate release phentermine.   "
203979|NCT00518479|"     Uncontrolled high blood pressure can cause heart muscle 'thickening', and this increases the     likelihood of complications and death. The high blood pressure explains some but not all of     this increase in heart size. This study will investigate the other causes, and will measure     the heart muscle 'thickness' very accurately using the latest and most accurate technique     called cardiac magnetic resonance imaging (MRI). The best way to treat this heart thickening     remains to be determined. We hope to be able to show that by specifically targeting the cause     of heart muscle thickening we can reduce its occurrence more effectively than by other     standard means of blood pressure treatment   "
203980|NCT00518492|"     Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent     for this duration of immunity study to provide up to two additional blood samples. SBA & IgG     testing will be done on these samples taken at 6 & 12 months. The sites participating in this     duration of immunity study are the same sites participating in the 6108A1-500 study.   "
203981|NCT00518505|"     The purpose of this study is to review pre-operative studies and patient evaluation reports     and compare those with the results of the post-operative studies, patient evaluation reports     and subjective patients' outcomes following laparoscopic surgery for gastroesophageal reflux     disorder. This will allow us to evaluate how patients have benefited from the procedure.   "
203982|NCT00518518|"     The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied     preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to     grass pollen. The investigators will assess clinical symptoms, reliever drugs usage, lung     function, chosen markers of allergic inflammation, bronchial hyperreactivity with     methacholine, and presence and type of allergy after two years of sublingual immunotherapy     (SLIT) in children with asthma.   "
203983|NCT00518531|"     The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg     denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW)     treatment at the end of treatment period 1 (12 months).   "
203984|NCT00518544|"     Background: Individuals with type O blood have reduced factor VIII and von Willebrand factor     levels compared to the non-O counterpart. Infusion of hydroxyethyl starch (HES) impairs     coagulation and, in O blood type, apparent coagulopathy can develop after HES infusion. A     newly market-released balanced HES (670/0.75) has physiologic pH and balanced electrolytes     including calcium, which are beneficial to coagulation. Studies comparing balanced HES     (670/0.75) with saline-based HES (130/0.4), previously known the least coagulopathic are     rare. Therefore, we try to reveal the difference of coagulation, pH/electrolyte balance, and     bleeding amount between the non-O and O blood types after infusion of these two newest HES.      Methods: Each 20 of non-O and type O ASA 1 or 2 patients scheduled for spinal surgery     involving 2 or 3 spinal levels were enrolled. 20 ml/kg of saline-based HES (130/0.4) or     balanced HES (670/0.75) was administered during operation. Blood loss, coagulation and     metabolic profiles were checked at pre-infusion (T0), 5 min after infusion (T1), 4 hrs after     infusion (T2) and 24 hrs after infusion (T4).   "
203985|NCT00518557|"     The purpose of this study is to investigate safety and potential therapeutic benefits for     patients with hepatocellular carcinoma by transcatheter chemoembolization with the     recombinant endostatin (commercially available in China)which is also administrated via the     hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment     may inhibit the proangiogenic effects induced by the hypoxia of TACE.   "
203986|NCT00518570|"     The purpose of this study is to investigate the clinical efficacy of Levetiracetam in the     treatment of symptoms of premenstrual dysphoric disorder (PMDD) in an open label study.   "
203987|NCT00518583|"     The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and     trastuzumab in patients with operable breast cancer. Patients will be treated with the     combination for 18 weeks, followed by surgery.   "
203988|NCT00518596|"     India, with one of the world's largest populations, continues to struggle with extremely high     infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent     of deaths among community-born (and 20 percent of mortality among hospital-born) infants.     This study is the first phase of a multi-phase project investigating interventions to prevent     neonatal infection in India.   "
203989|NCT00518609|"     India, with one of the world's largest populations, continues to struggle with extremely high     infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent     of deaths among community-born (and 20 percent of mortality among hospital-born) infants.     This study is the first phase of a multi-phase project investigating interventions to prevent     neonatal infection in India.   "
203990|NCT00518622|"     The purpose of this study is to investigate the effectiveness, safety, and tolerability of     MK7009 in patients infected with Hepatitis C   "
203991|NCT00518635|"     Study hypothesis:      Growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor     (IGF)-I, can improve insulin sensitivity and the metabolic profile of women with polycystic     ovary syndrome.      Study aims:      To determine the mechanism of how low dose GH treatment affects the body's sensitivity to     insulin actions and whether this low GH dose can affect the body's handling of steroid     hormone levels (cortisol clearance) and testosterone (male hormones) in obese women with     polycystic ovary syndrome.      Study design:      Obese women with polycystic ovary syndrome, but not recently been on GH treatment, and     presently attending Outpatients Clinic will be invited to participate in this study. The     subjects will be assessed at the initial visit to ascertain their suitability before further     participating in the study. If suitable, an equal number of women will be randomized to     receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging     over for another 12 weeks of treatment after a 4-week washout period. Before, during and     after treatment, the subjects will be assessed at frequently with blood tests, scans and fat     biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and     Translational Research Institute (OCTRI). At the first, second and final visit, testing will     include scans to measure the amount of whole body fat and fat in the stomach area, muscle,     and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy)     analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by     growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in     the body (insulin sensitivity) will be collected at all visits of the study.   "
203992|NCT00518648|"     The REFINE-PD study is a controlled trial embedded within a larger cluster controlled study     (the IMPACT study). The study aims to investigate the efficacy of a multifactorial falls     prevention program for patients with Parkinson's Disease (PD). This program contains     PD-specific elements (e.g., optimizing dopaminergic therapy), plus a generic falls prevention     program. The intervention will be tailored to each individual's specific risk profile for     falls, as identified during detailed baseline examination.   "
203993|NCT00518661|"     This is a retrospective chart review. This proposed study aims to document the risk factors     for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the     adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be     assessed.   "
203994|NCT00518674|"     The aim of this randomized, double-blind and placebo-controlled study is to evaluate the     specific role of injection of local anesthetic into the intra- vs. extraarticular tissues     after toal knee arthroplasty.   "
203995|NCT00518687|"     This study will assess the efficacy of a single dose of V710 vaccine to prevent serious     Staphylococcus aureus infections following elective cardiothoracic surgery. The study will     also evaluate the immune response and general safety of the V710 vaccine.   "
203996|NCT00518700|"     To compare corneal staining after contact lens instillation with a new MPS vs. RepleniSH   "
203997|NCT00518713|"     The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive     therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2     to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at     approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly     assigned to either a low, medium or high dose, or placebo. The study will include a baseline     period, a titration period and a maintenance period. After the maintenance period, patients     will either continue into an open-label extension study or enter the taper period with a     final visit 1 week after the last dose.   "
203998|NCT00518726|"     To evaluate the antibody response to each influenza vaccine antigen when administering a     single dose to subjects aged > 18 years   "
203999|NCT00518739|"     This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II     Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.   "
204000|NCT00518752|"     The purpose of this study is to compare how effective different ways of mouth cleaning are     for patients in a neuroscience intensive care unit with a breathing tube in their mouth.   "
204001|NCT00518765|"     This study will measure the effects of different doses of aliskiren on kidney blood flow and     function in healthy adults and determine how salt intake affects the response to aliskiren.   "
204002|NCT00518778|"     This exempt chart review study will try to determine the clinical presentation, prognostic     factors, response to different treatment modalities and mortality among patients diagnosed     with fusariosis after solid-organ transplantation.   "
204003|NCT00518791|"     The aim of the present study is to evaluate the (cost) effectiveness of a new health care     system in which an individualised multidisciplinary assessment is given to patients with     Parkinson's Disease(PD)in combination with treatment by a dedicated team of specifically     trained health professionals, compared to usual care. Overall, we anticipate to gain more     insight in the clinical effectiveness and health care costs of multidisciplinary treatment in     PD.   "
204004|NCT00518804|"     LAY SUMMARY:      IBI is costly and there are currently long waitlists of children who are in need of     treatment. The investigators have clinical and ethical obligations to determine more     appropriate alternatives to IBI for children making few gains because all children with     autism deserve treatment based on their needs. This study is designed to determine the     effectiveness of a functional skills group intervention, based on the principles of applied     behaviour analysis, for children responding slowly to IBI. Specifically, it will investigate     the effectiveness of functional behavioural skills training in addition to IBI at increasing     a child's independence in day to day communication and self-help skills and reducing     behaviour problems, as well as increasing parental competence and decreasing caregiver strain     compared with IBI alone. Having an effective alternative to IBI for children making few gains     is relevant from the standpoint of i) preventing exposure to potentially intrusive     interventions for those children making few gains in IBI, ii) allowing children making few     gains in IBI to access effective treatment, iii) opening limited IBI spots for children who     would benefit from IBI, and iv) making better use of limited health resources. Overall, the     results will be of interest to parent, clinicians, researchers and funding bodies.      HYPOTHESES      Four main hypotheses are presented to examine the effectiveness of involvement in the ABA     functional skills group in improving parent training and functional skills and behaviour in     young children with ASD who do not master the ELM. We focus our hypotheses on child measures     of functional self help skills, behaviour and cognition as well as parental measures of     caregiver strain and sense of competence.      Participants (i.e. children predicted to have poor response to IBI alone) who attend the     functional skills group for 8 months will have:        1. greater decreases in interfering behaviour as measured on the Developmental Behaviour          Checklist and ratings of behaviour during observations compared to children receiving          IBI alone.        2. greater increases in self-help as measured on the Vineland Adaptive Behaviour Scales II,          and greater independence in eating, toileting, requesting, hand washing, and responding          to name as measured by independent ratings of these skills compared with those children          receiving IBI alone.        3. parents of these children will have greater improvements in their sense of competence as          a parent and greater reductions in caregiver strain, compared with parents of children          receiving IBI alone.        4. a similar pattern of little or no change in cognitive function compared with children          who receive only IBI based on the Stanford Binet. In other words, there will be no          difference between the experimental and control group on the measure of cognitive          functioning   "
204005|NCT00518817|"     This study will have significant impact on muscular dystrophy patients as it promotes early     screening for heart disease. With early identification, beneficial medical therapy can be     started sooner, resulting in restoring and maintaining normal heart function. This is     critical to the survival of these patients. We have reported previously that heart failure in     all patients may have common mechanisms, the final common pathway. Heart failure is a     significant health problem with 5 million people in the US carrying the diagnosis and     accounting for 12-15 million office visits and 6.5 million hospital days per year. The number     of deaths from heart failure continues to increase. The data from this study could impact     patients worldwide with heart failure by offering new insight into an ever-growing disease     population and lead to significant changes in how they are currently treated.   "
204006|NCT00518830|"     A randomized clinical trial was carried out at primary care level in Santiago, Chile to     investigate a combined treatment for women suffering post-natal depression and preventing the     adverse consequences of this illness on infant's growth and development.   "
204007|NCT00518843|"     The primary hypotheses are:        -  A procedurally distinct family therapy is an effective and essential way to reduce          bingeing and purging in adolescents with BN, and leads to the long-term amelioration of          bulimic symptoms.        -  Family therapy is an effective way to bring about meaningful improvements in family          interaction.        -  Family therapy will produce significantly larger reductions in bulimic symptoms and          improved family interaction in adolescents with BN compared to a control supportive          psychotherapy.   "
204740|NCT00521378|"     A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.   "
204009|NCT00518869|"     The objective of this study is to evaluate the efficacy and safety of PG2 as a complementary     treatment to conventional chemotherapy among NSCLC patients. In reference to previous     studies, Clinical Benefit Response and Incidence of Grade III plus VI Neutropenia will be     used as the primary endpoints in this study. Clinical Benefit Response is a metric     measurement including change in cancer or cancer treatment related fatigue which is related     to chronic fatigue syndrome (CFS), change in karnofsky performance status and change in     weight. The secondary endpoints include patient's global quality of life, and the blood     c-reactive protein level which is related to weight change, tumor response, survival time,     incidences of myelosuppression (including neutropenia, anemia and thrombocytopenia) and the     related G-CSF and antibiotics consumption.   "
204010|NCT00518882|"     This trial is conducted in Europe and the United States of America (USA). The aim of this     trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to     subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea     or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week     randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received     liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both     combined with OAD treatment.   "
204011|NCT00518895|"     This study is being performed to prospectively determine whether dacarbazine plus Genasense     is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with     advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit     of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial     of dacarbazine plus Genasense.   "
204012|NCT00518908|"     Organ protection, volatile anesthetics, postconditioning, hepatic surgery   "
204013|NCT00518921|"     This is a multi-center and multi-national,randomized, double blind, placebo-controlled,     28-day treatment study with BAY 68-4986 taken orally or a matching placebo.   "
204014|NCT00518934|"     The purpose of this study is to analyze the safety and efficiency of therapeutic angiogenesis     for patients with limb ischemia by transplantation of human cord blood mononuclear cells.   "
204015|NCT00518947|"     Verapamil has been found in some but not all studies to have antimanic activity. Therefore,     we investigated the use of verapamil, alone or as an adjunctive treatment, in manic patients     who did not respond to an initial adequate trial of lithium. Each study phase lasted three     weeks. Subjects were treated openly with lithium in Phase 1 (n=45). Those who failed to     respond were randomly assigned to double-blind treatment in Phase 2 with either verapamil     (n=10) or continued lithium (n=8). Phase 2 responders were continued on the same medication     in Phase 3. Phase 2 nonresponders (n=10) were assigned to combined verapamil/lithium in Phase     3.   "
204016|NCT00518960|"     The purpose of this study is to determine the effectiveness of ProAlgaZyme in increasing     levels of HDL 'good' cholesterol and decreasing total cholesterol and C-reactive protein in     patients with Metabolic Syndrome.   "
204017|NCT00518973|"     This research study is being held at UCSD to determine whether the medication Quetiapine     helps people suffering from anorexia nervosa by reducing core eating disorders symptoms. This     study will see if the medication Quetiapine helps symptoms of anxiety, depression, and     obsessionality, in addition to increasing BMI. Men and women between the ages of 18-65 and     are currently suffering from anorexia nervosa are needed.   "
204018|NCT00518986|"     The primary objective of the study is to evaluate whether armodafinil at a target dosage of     200 mg/day is more effective than placebo treatment in improving excessive sleepiness in     patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major     depressive disorder or dysthymic disorder.   "
204019|NCT00518999|"     Longitudinal investigation of cognitive, emotional and illness awareness of schizophrenia     outpatients (Shalvata Mental Health Center). The study uses computerized assessment of     cognitive functioning and questionnaire to assess performance of patients assessed in the     past as part of a routine clinical assessment.   "
204020|NCT00519012|"     Introduction and Purpose:      Most of the guidelines for the treatment of major depression recommend the use of     antidepressants for 4 to 8 weeks. On the other hand, it has been recently reported that they     start to show their antidepressant efficacy within a couple of weeks (1,2), contrary to the     conventional theory. In addition, a good response (i.e. a 20% reduction in the     Montgomery-Åsberg Depression Rating Scale [MADRS]) at week 2 is proposed to be a predictor of     subsequent remission at week 6 (3,4), while nonresponse at week 2 could predict unfavourable     outcome at week 8 (5). Furthermore, early worsening is suggested to be related to a low rate     of remission at weeks 8 and 12(6).   "
204021|NCT00519025|"     This is a retrospective chart review study. The proposed study aims to document the risk     factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally,     the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be     assessed.   "
204022|NCT00519038|"     The purpose of this study is to determine whether the use of clinical pathways improves the     quality of the hospital care of decompensated heart failure patients.   "
204023|NCT00519051|"     A randomized clinical trial was carried out at primary care level in Santiago, Chile to     compare a pharmacological intervention for depressed mothers controlled by phone from a     central level (TM) and the usual treatment (TH) and its impact on children's mental health.      Hypothesis: pharmacological intervention for depression controlled by phone from a central     level will be more effective than usual care in depressed mothers.   "
204024|NCT00519064|"     This phase III is designed to confirm the previous trial results evaluating the safety,     clinical tolerability and immunogenicity of the 2006-2007 formulation of Novartis Vaccines'     adjuvanted influenza vaccine and subunit influenza vaccine in adults with underlying chronic     diseases.   "
204025|NCT00519077|"     The purpose of this study is to demonstrate the activity (response rate and rate of stable     disease) of Iressa administered as a single agent escalated to a dose that produces grade 2     skin toxicity in patients with recurrent and/or metastatic squamous cell carcinoma of the     head and neck (SCCHN).   "
204026|NCT00519090|"     In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with     imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their     Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase     (CML-CP).   "
204029|NCT00519129|"     Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the     coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope     while a traditional fluoroscopy device will only show instant pictures. We want to     investigate whether the 3D-imager causes the patient less pain and is more time consuming     than ordinary fluoroscopy   "
204030|NCT00519142|"     The primary objective of this study is to demonstrate whether mitiglinide administered in     combination with metformin is more effective than metformin alone in patients with Type 2     diabetes mellitus (T2DM) whose blood sugar is not well controlled taking metformin alone.     This is a 24 week study which measures improvement in blood sugar after of treatment.   "
204031|NCT00519155|"     The purpose of the study is to gain experience of safety and efficacy with MD05 in man in     alveolar bone regeneration.   "
204032|NCT00519168|"     Recent research provides evidence that disrupted circadian rhythms, including hormonal     patterns and sleep, are associated with increased risk of breast cancer incidence and faster     progression to mortality. We have observed that a loss of normal diurnal cortisol rhythm     associated with more awakenings during the night predicts early mortality with metastatic     breast cancer. Other recent studies have shown that nighttime shift work is associated with     higher breast cancer incidence, and in a murine model disrupting circadian cortisol cycles     produced a doubling of implanted tumor growth. There is also recent evidence that abnormal     clock genes are associated with cancer. However, it is not clear whether sleep disruption per     se affects breast cancer progression, or whether such an effect is mediated by hormonal and     immune dysregulation of this prevalent and hormone-mediated cancer. We propose to study sleep     disruption as a prognostic factor in the progression of metastatic breast cancer. We will     also examine sleep patterns in association with disrupted circadian rhythms of cortisol,     ACTH, and melatonin as well as measures of immune function known to be salient to breast     cancer progression. These are natural killer cell cytoxicity and specific cytokine, IL-6. We     plan to recruit 105 women 45 years through 75 years with metastatic or recurrent breast     cancer and 20 age and SES-matched controls for a two-week at home sleep study with Actiwatch     and two nights of in-home EEG monitoring, followed by 28 hours of continuous blood sampling     and one night of EEG sleep monitoring in our lab at Stanford. This will provide a full     examination of circadian hormones associated with sleep patterns. We will relate these     assessments to the subsequent course of breast cancer progression. Results of this study will     provide specific evidence regarding how improved sleep management may affect the course of     breast cancer. Aim 1: To study 24-hr diurnal rhythms of HPA axis hormones and melatonin in     women with metastatic or recurrent breast cancer. Hypothesis 1: Women with metastatic or     recurrent breast cancer will have reduced amplitude and disrupted phase of 24-hr diurnal     rhythms of cortisol, ACTH, and melatonin. Aim 2: To describe sleep disruption in women with     metastatic breast cancer and examine psychosocial, endocrine, and immune factors that may be     associated with sleep disruption. Hypothesis 2: Women with metastatic or recurrent breast     cancer will have a higher incidence of both at home and laboratory-examined sleep disruption     than control women without breast cancer. Hypothesis 3: Poorer sleep quality will be     associated with more pain, more emotional suppression in response to stressors, less     emotional support, greater depression and anxiety, and greater perceived and traumatic     stress. Hypothesis 4: Poorer sleep quality and quantity of sleep and daytime sleepiness and     fatigue will be associated with abnormal circadian neuroendocrine (i.e., cortisol, ACTH, and     melatonin) and immune patterns (i.e., suppressed day and night time NK activity and loss of     NK rhythms; increased day time IL-6 levels and /or loss of IL-6 rhythm). Aim 3: To study the     relationship between sleep disruption and survival time among metastatic and recurrent breast     cancer patients. Hypothesis 5: Poorer sleep quality and quantity of sleep will predict     shorter survival. Hypothesis 6: Reduced diurnal amplitude and an abnormal phase of cortisol     will predict shorter survival. Explanatory Aim 4: To investigate whether sleep disruption     mediates the relation of psychosocial factors to health outcomes.   "
204033|NCT00519181|"     Reversible acetylation of the histone tails plays an important role in the control of     specific gene expression. Mounting evidence has established that histone deacetylase     inhibitors such as Valproic Acid (VPA)selectively induce cellular differentiation and     apoptosis in variety of cancer cells. In a single-center, one year open-label trial, 19     HAM/TSP patients were treated with oral doses of VPA (20mg/Kg/day). Primary end-points were     the therapeutic safety and the effect on HTLV-1 proviral load (a significant and sustained     decrease was expected). Secondary end-point was the neurological status before and after     one-year treatment.   "
204034|NCT00519194|"     The purpose of this study is to test the safety and efficacy of the Epicor LP Cardiac     Ablation System for treating permanent atrial fibrillation during concomitant open chest     and/or open heart surgery for one of more of the following procedures: mitral valve repair or     replacement, aortic valve repair or replacement, tricuspid valve repair or replacement,     coronary artery bypass surgery or patent foramen ovale (PFO closure).   "
204035|NCT00519207|"     The objective of this study is to determine the relative efficacy of sucrose, liposomal     lidocaine, and sucrose plus liposomal lidocaine, on reducing pain during venipuncture in     newborn infants.   "
204036|NCT00519220|"     The objective of this study is to review studies and patient symptoms before and after     laparoscopic Heller myotomy to assess outcomes following laparoscopic surgery for achalasia.   "
204037|NCT00519233|"     The present study will investigate the safety, tolerability and spectrum of side effects of     AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and     potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC.   "
204038|NCT00519246|"     With the incremental trend of benign breast tumor, the surgical process of mastectomy was     proceeded too much every day, especially in the Maternal Health Care Hospital, but whether     the investigators can find another way to relieve the postoperative pain after such an     operation is still unknown. The investigators hypothesized that the pain from the relatively     small surgery may not be significant compared to different treatments, even if no drug was     delivered to them. The investigators are enrolling patients who underwent mastectomy from     benign breast tumor, and are observing the analgesic effects of different drugs.   "
204039|NCT00519259|"     The purpose of this study is to assess safety and pharmacokinetics of sublingual lobeline in     healthy normal volunteers.   "
204040|NCT00519272|"     The goal of this behavioral research study is to look at the reasons that may prevent women     from getting early treatment for their cervical cancer.   "
204041|NCT00519285|"     Primary objective was to demonstrate overall survival improvement with aflibercept compared     to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent     prostate cancer (MAIPC).      The secondary objectives were:        -  To assess the efficacy of aflibercept compared to placebo on other parameters such          prostate-specific antigen (PSA) level, cancer related pain, progression free survival          (PFS), tumor-based and skeletal events and health-related quality of life (HRQL);        -  To assess the overall safety in both treatment arms;        -  To determine the pharmacokinetics of intravenous (IV) aflibercept in this population;        -  to determine immunogenicity of IV aflibercept.   "
204042|NCT00519298|"     Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in     healthy subjects.   "
204054|NCT00519454|"     This study involves research to investigate how estrogen affects women of childbearing age     and its correlation to Systemic Lupus Erythematosus. The findings from this study might help     determine how body cells, called T Cells, react to estrogen. The study will seek to determine     if cells from women with Lupus, react differently from cells in persons without Lupus. We     will attempt to identify genetic factors that determine the effects of estrogen on Lupus     cells.   "
205444|NCT00540501|"     This study is a 4 period study to see if there is any interaction between Orally-Administered     Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects   "
204043|NCT00519311|"     People with intellectual disability die five to twenty years earlier than the general     population. They also experience high levels of unrecognised disease and receive inadequate     levels of health promotion or screening. Although they comprise 2.7% of our population (502     000 Australians) they receive scant, if any, attention in the health literature.      The barriers to good health for this population include: communication difficulties, impaired     recall of significant health information, and inadequate training of health service     providers. This project attempts to minimise some of these barriers through the use of a     Health Intervention Package. Use of this package has been evaluated in adults, but not in     adolescents, with intellectual disability.      The Health Intervention Package includes a comprehensive health review, called the     Comprehensive Health Assessment Program (CHAP), which is performed by the adolescent's     general practitioner, and a diary, the Ask diary, used to collect and store health     information and to enhance health advocacy skills. We specifically aim to test if adolescents     with intellectual disability using this package will receive better health screening and     prevention (our primary outcomes). We also aim to test if using the package results in     improved health advocacy by adolescents with intellectual disability and their parents (our     secondary outcomes). The tool should also be acceptable to those involved (another secondary     outcome). To investigate these aims we propose a clustered randomised controlled trial, a     methodology we have used successfully in two previous trials. We will recruit 1000     adolescents (and their carers and teachers) in Special Education Schools and Special     Education Units in Queensland.      The CHAP health review aims to produce shorter-term benefits of improved health     screening/promotion and disease detection, such as increased sensory testing, identification     of vision or hearing impairment, and improved immunisation rates. The Ask diary is intended     to produce longer-term benefits such as improved communication about health matters, improved     health advocacy skills, improved health record keeping, and increased health maintenance.   "
204044|NCT00519324|"     The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in     patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer)     whose cancer has progressed despite prior treatment.   "
204045|NCT00519337|"     The purpose of this study is to see if ascorbic acid (Vitamin-C) therapy will reduce     inflammation following heart surgery.   "
204046|NCT00519350|"     Patients undergoing major surgery, trauma or burns are prone to develop an exacerbated     inflammatory response, which is potentially lethal to the individual. Recently, the     researchers' group showed in a rodent model of hemorrhagic shock that high-fat feeding     administered before shock attenuates inflammation and reduces intestinal and hepatic damage.     In the mechanism that underlies this protective effect, the release of cholecystokinin in gut     wall and activation of efferent vagus bundles are crucial events. Before investigating the     effect of high-fat nutrition in clinical setting, suitable markers of inflammation and organ     damage need to be selected. In this study, blood will be collected in patients undergoing     different types of operations. Consequently several markers for inflammation and organ damage     will be determined. Hence, suitable parameters for a future high-fat intervention study will     be selected.   "
204047|NCT00519363|"     This is an open label pilot clinical trial on a cohort of 15 Lupus patients from the Center     for Rheumatic Disease. Clinical evaluations and laboratory tests will be done and then if     eligible, the patients will receive oral atorvastatin, at a fixed dose of 40mg/day. Statins     have been shown to induce clinical improvement in rheumatoid arthritis patients, as well as     lupus patients. The effectiveness has been noted within 8 to 14 days, we will do our study     for 3 months. Clinical and laboratory tests will be checked at the 1 and 3 month interval. We     hypothesize that statin drugs (atorvastatin) slow the progression of SLE(Systemic Lupus     Erythematosus) disease activity and down regulates TLR(Toll-like receptors) 2,4,and 9     pathways in addition to lowering lipid levels.   "
204048|NCT00519376|"     This study will involve the use of a new compound, GW642444 that is being developed for the     treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on     cells in the lungs, causing some of the muscles around the lungs to relax and open up better     (bronchodilation), making breathing easier. When a medicine is made into a form ready to be     given to patients, the active ingredient is often prepared in the form of a salt, and     inactive ingredients (excipients) are often added. Inactive ingredients might be used to help     a medicine work better, to make it easier to produce the medicine, or to make it easier to     get an accurate dose of medicine. In previous studies the study drug has been given as a dry     powder in the form of either the 'H' salt (with the excipient lactose), or in the form of the     'M' salt (with the excipients lactose and cellobiose octaacetate). In this study the 'M' salt     form of the study drug has been prepared with lactose and a new excipient called magnesium     stearate (instead of cellobiose octaacetate). Participants in this study will receive both     the 'H' salt (GW642444H) and the new 'M' salt (GW642444M) containing magnesium stearate. This     study will be the first time the new 'M' salt form of the study drug will be given to COPD     patients.   "
204049|NCT00519389|"     This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the     safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or     placebo in healthy adults 18 to 40 years of age.   "
204050|NCT00519402|"     Introduction: There is currently no long-term study, which compares the outcomes of partial     tonsillectomy to conventional tonsillectomy. We hypothesize that there will be little     significant tonsillar regrowth with partial tonsillectomy.      Background and Significance: Tonsillectomy is the most common major surgical procedure     performed on children in the United States with nearly 300,000 procedures performed each     year, primarily for the indication of obstructive sleep disordered breathing (OSDB).     Conventional (total) tonsillectomy removes the tonsillar capsule, and partial tonsillectomy     preserves the capsule by shaving away the tonsils using an endoscopic microdebrider. Partial     tonsillectomy results in less pain, fewer days to normal activity and diet, and fewer days of     analgesics than total tonsillectomy. There are no significant differences between the     techniques in blood loss or postoperative life improved Historical evidence suggests that     eventually there will be tonsillar regrowth with partial tonsillectomy. However, in a 2003     follow-up report of 243 children undergoing partial tonsillectomy and 107 undergoing complete     tonsillectomy from 1998 through 2002 for OSDB there was no evidence of significant tonsillar     regrowth. (1) We will follow-up children undergoing partial or complete tonsillectomies at     the Cleveland Clinic from 1998 through 2002. There will be standardized tonsillar     examinations by two observers, with a third observer in cases of significant disagreement,     and questionnaires evaluating sleep apnea and daytime sleepiness, and number of tonsillar     infections.      If there are a large number of children with recurrent tonsillar symptoms post partial     tonsillectomy, the procedure should be abandoned. However, if follow-up reveals comparable     tonsillar symptoms for partial and the total tonsillectomy, perhaps the partial procedure     should replace the total tonsillectomy as the standard operation to relieve tonsillar OSDB.     This could eventually result in millions of less lost days of work and school in the United     States.   "
204051|NCT00519415|"     A new appliance will be used to transfer the tongue force during its physiological activity     to advance the nasomaxillary complex; this method will be compared with the traditional     method which uses a Facemask appliance.   "
204052|NCT00519428|"     This study will utilize a randomized double-blind design to evaluate whether initial     treatment with two anti-depressant medications (escitalopram and bupropion) results in more     rapid remission and greater over-all remission rates than either monotherapy in 240 depressed     subjects.   "
204053|NCT00519441|"     Patients who have had laparoscopic surgery for the treatment of achalasia will be asked to     have pH studies done in order to determine is these patients suffer from reflux after     surgery.   "
207638|NCT00566462|"     This is a two-arm, double-blind, placebo-controlled study.   "
204055|NCT00519467|"     Drug resistance to a range of antimalarial treatments has become widespread in Africa, South     East Asia and South America. Because the rapid spread of drug resistance threatens a public     health disaster in these areas of the world and to comply with the WHO-Roll Back Malaria     policy of using Artemisinin-based combination therapies (ACT), there is a need to develop     new, safe, effective and affordable ACT.      Chlorproguanil-dapsone-artesunate (CDA)is a new ACT that is being developed for the treatment     of uncomplicated falciparum malaria in Africa.   "
204056|NCT00519480|"     This study will assess safety and tolerability of metformin plus GSK189075 in people with     Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if     they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a     run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a     13-day treatment period, and a follow-up visit about 1 week after the treatment period.     Volunteers will remain in the research clinic beginning 2 days before they receive the first     dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of     the 12th day of dosing until the morning after the last dose. They will have clinic visits on     dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring     their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart     rate, laboratory tests on blood and urine, physical examinations, reports of drug side     effects and ECGs will be obtained during the clinic visits to assess safety.   "
204057|NCT00519493|"     This investigator initiated study, single-blinded, parallel, randomized study will be     conducted in subjects with 2 or more keloids similar in size and duration on a similar area     of the body. The response of the closure techniques will be evaluated by clinical and     instrumental assessments. Each qualified subject will be assessed and the keloids will be     randomly assigned to the Clozex or suture closure. One keloid will be surgically excised and     the surgical wound generated will be randomized to be closed with Clozex. A second keloid     will be surgically excised and the surgical wound generated will be randomized to be closed     with sutures. The inflammation index and the keloid recurrence rate at each surgical wound     closure site will be compared.   "
204058|NCT00519506|"     The aim of the study is to determine the diagnostic accuracy of 99mTc ThromboView® SPECT     imaging for the detection of acute pulmonary embolism (PE) in patients for whom there is a     moderate to high clinical suspicion for PE.   "
204059|NCT00519519|"     Bleeding peptic ulcers are one of the major causes of morbidity and mortality for hospital     emergency admissions.The initial treatment is endoscopic therapy followed by intravenous     omeprazole. However the optimal dosage of omeprazole is not known. We conducted this study to     find out the optimal dosage in such clinical scenario.   "
204060|NCT00519532|"     The objective of this open-label extension is to assess the long-term effect of the 24-hour     transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and     non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the     rotigotine transdermal patch will also be evaluated.   "
204061|NCT00519545|"     The goal of this study is to help determine the biochemical mechanisms underlying previously     demonstrated health benefits of prayer, and to track humoral changes in various prayer     activities.   "
204062|NCT00519558|"     This trial is conducted in Japan. The aim of this trial is to demonstrate superiority of the     effect of NN-220 compared with that of placebo as assessed by the change in percent in     truncal fat (kg) from baseline to 24 weeks' treatment (end of treatment) in patients with     Growth Hormone Deficiency in Adults (GHDA).   "
204063|NCT00519571|"     To investigate the safety and effectiveness of the ImplantLock device and its contribution to     8.0 mm long root-form endosseous implants stability under immediately applied continuous     functional loading.   "
204064|NCT00519584|"     This study will test the hypothesis that ropivacaine in combination with either systemic or     local steroid provides comparably longer-lasting analgesia tha ropivacaine alone.   "
204065|NCT00519597|"     Obstructive sleep apnea (OSA) worsens the prognosis in patients with coronary artery disease     (CAD). Many of these subjects do not report daytime sleepiness, and therefore, are not     considered for OSA treatment with continuous positive airway pressure (CPAP). There is lack     of evidence regarding the impact of CPAP on the long-term prognosis of CAD patients with OSA.     The Randomized Intervention with CPAP in CAD and OSA (RICCADSA) trial is designed to address     if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction,     stroke and cardiovascular mortality over mean follow-up period of 3-years in CAD patients     with OSA without daytime sleepiness.Secondary outcomes include cardiovascular biomarkers,     cardiac function, maximal exercise capacity and quality of life at baseline, 3-month- and     1-year follow-up as well as polysomnographic findings and adherence to CPAP therapy.   "
204066|NCT00519610|"     The objective of this study is to evaluate the pre-operative symptoms and medical history of     patients with portal hypertension who have undergone placement of H-graft portacaval shunts     and correlate this with patient outcomes.   "
204067|NCT00519623|"     This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an     investigational basal insulin patch in type 1 diabetes patients.   "
204068|NCT00519636|"     The purpose of this replicate study to FFU105924 is to provide data on subject preference of     FFNS as compared with FPNS.   "
204069|NCT00519649|"     The purpose of this study is to assess the persistence of immunity to hepatitis B in children     who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol     Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
204070|NCT00519662|"     This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in     humans.   "
204071|NCT00519675|"     The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic     hand eczema that is refractory to topical corticosteroids.   "
204085|NCT00519857|"     Tibolone 1.25 mg is an effective treatment for the prevention of osteoporosis and is expected     to be effective in preventing fractures in osteoporotic women. Tibolone could be more     acceptable for long-term use, in particular since it does not induce a regular withdrawal     bleed.      The objective of this trial is to compare placebo and tibolone, a steroid with tissue     specific activity, in the prevention of spinal fractures in women meeting the WHO criteria     for osteoporosis or who have asymptomatic vertebral fractures.   "
204072|NCT00519688|"     We hypothesize that combination of tegafur/uracil(UFUR) and thalidomide, both of which have     been shown to be active in some HCC patients,may be a highly useful regimen for the treatment     of advanced HCC. There are several rationales underlying this combination. First,     anti-angiogenesis therapy may improve the efficacy of chemotherapy by normalizing the     abnormal vasculature in tumors, and thus improving the delivery of chemotherapeutic agents to     the tumor cells. Second, chemotherapeutic drugs given in a low-dose, un interrupted, and     protracted way can induce anti-tumor effect through the anti-angiogenesis activity     (so-calledmetronomic chemotherapy). The efficacy of metronomic chemotherapy can be     suppressed by VEGF/VEGFR signaling pathways and thus can bo further potentiated by agents     blocking those survival signals of endothelial cell. In this regard, tegafur/uracil appears     to be a good candidate for metronomic chemotherapy because tegafur/uracil and its metabolites     bave already been shown to inhibit angiogenesis in several pre-clinical models.   "
204073|NCT00519701|"     The purpose of this study is to asses prospectively the safety and efficacy of hydroxyurea     therapy in children with Sickle cell Anemia between ages 18 months and 5 years, with special     emphasis on the ability of hydroxyurea to prevent or reverse chronic organ damage.   "
204074|NCT00519714|"     A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study. Following a     6-8 week placebo and dietary-controlled baseline period, approximately 195 men and women with     either hypertriglyceridemia or mixed hyperlipidemia with serum triglycerides (TG) > 200 mg/dl     (2.26 mmol/l) will be randomized to receive either placebo, 30 mg 1-MNA or 90 mg 1-MNA three     times daily for twelve weeks. Lipid and ancillary exploratory parameters will be evaluated at     screening, during the baseline period, upon randomisation and throughout the 12-week active     treatment period. Additionally, blood samples will be drawn at randomisation and at clinic     visits during the active treatment period for sparse sampling population pharmacokinetic     assessments. All blood samples for lipid assessments and glucose measurements will be     collected following a 12-hour fast. Safety and tolerability will be assessed throughout the     trial through the evaluation of physical exams, ECGs, routine hematology and blood chemistry     testing, and adverse events.   "
204075|NCT00519727|"     The primary purpose of this trial is to assess the safety of ISIS 325568 when given at     increasing single doses and to assess the safety of the same doses when given multiple times.   "
204076|NCT00519740|"     The study is meant to observe the influence of nutrition on nasal and bronchial discomfort in     patients with allergy on grass pollen after specific bronchial provocation. Therefore, the     investigators will record the patients' nutrition habits and measure the blood level of long     chained polyunsaturated fatty-acids.   "
204077|NCT00519753|"     The purpose of this study is to assess the safety and efficacy of transitioning uncontrolled     glaucoma patients to DuoTrav from other mono or adjunctive therapies.   "
204078|NCT00519766|"     Smoking during pregnancy is the single most preventable cause of illness and death among     mothers and infants. Because of the stigma associated with tobacco use during pregnancy,     pregnant women are less likely to disclose their smoking status to doctors or study     researchers. This study will evaluate the use of a new biomarker of nicotine metabolism to     estimate tobacco use in a group of pregnant women who participated in the New England Smoking     Cessation and Reduction in Pregnancy Trial (SCRIPT).   "
204079|NCT00519779|"     This study is designed to examine the effects of fish oil on immune function and mood in     medical students.   "
204080|NCT00519792|"     Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon     subcutaneously at a constant rate for 90 days.      This study is being performed to evaluate the safety and antiviral effects of omega     interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects     with chronic Hepatitis C genotype 1.   "
204081|NCT00519805|"     RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in     patients with lung cancer. It is not yet known whether dalteparin is effective in preventing     blood clots in patients with lung cancer.      PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing     blood clots in patients with lung cancer.   "
204082|NCT00519818|"     This study will test a new, extended release form of hydrocortisone called Chronocort in     patients with congenital adrenal hyperplasia (CAH). People with CAH do not make enough of the     adrenal hormones cortisol and aldosterone, and their adrenal glands make too much of the sex     hormone androgen. Medicines called glucocorticoids (hydrocortisone, dexamethasone and     prednisone) are currently used to treat CAH, but finding the best dose of these drugs that     effectively lowers androgens without causing undesirable side effects, such as weight gain     and slow growth rate in children, is often difficult to achieve.      Adolescents and adults with CAH due to 21-hydroxylase deficiency may be eligible for this     study. Children 16 years of age and older are eligible with confirmation by bone age that     they are no longer growing.      Participants undergo the following tests and procedures during two inpatient visits one month     apart at the NIH Clinical Center:        -  Medical history and physical examination.        -  Medications: Following 7 days of Cortef (standard drug treatment for CAH), patients          begin taking Chronocort on day 3 of hospitalization and continue the tablets once a day          for 1 month.        -  Blood tests: A catheter (plastic tube) is inserted in a vein and left in place for          frequent blood draws in order to avoid repeated needlesticks. Blood is drawn for          chemistries, blood count, pregnancy test in women, and for serial tests (up to 26          samples in a 24-hour period) to measure hormone levels.        -  24-hour urine test.        -  Height and weight measurements.      Between the two hospitalizations, patients are contacted by NIH weekly to check for possible     side effects from Chronocort. Two weeks after the first visit, patients also will have blood     drawn by their regular doctor or a local clinic. A few days before the second     hospitalization, patients undergo a 20-minute telephone questionnaire about energy level and     well being.      About 30 days after discharge from the second hospitalization, patients are followed up with     a telephone call to see how they are doing.   "
204083|NCT00519831|"     RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find     tumor cells and help kill them or carry tumor-killing substances to them. Others interfere     with the ability of tumor cells to grow and spread. Giving vinflunine together with cetuximab     may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving vinflunine together with cetuximab     works as second-line therapy in treating patients with stage IIIB or stage IV non-small cell     lung cancer.   "
204084|NCT00519844|"     This trial is conducted in Europe. The aim of this trial is to assess satisfaction with     growth hormone treatment in children of both sexes born small for gestational age and who are     receiving growth hormone treatment.   "
204132|NCT00513253|"     This study is designed to estimate the relative bioavailability of alternative lapatinib oral     formulations compared to the current tablet formulation.   "
204086|NCT00519870|"     In addition to being effective vasodilators, angiotensin-converting enzyme inhibitors (ACEIs)     and angiotensin receptor blockers (ARBs) exert neurohumoral inhibitory actions, such as the     inhibition of vascular remodeling and smooth muscle cell proliferation and the amelioration     of endothelial dysfunction. These beneficial effects, render those agents appropriate for use     in the treatment of pulmonary hypertension. However, data regarding the use of ACEIs or ARBs     in the treatment of PHT are limited. In this study, efficacy of an ARB, losartan was compared     with those of the calcium channel blocker, nifedipine in the treatment of pulmonary     hypertension using echocardiographic, 6-minute walk test (6MWT), cardiopulmonary exercise     test, and endothelin-1 levels.Losartan is as effective as nifedipine for reducing Doppler     echocardiographically measured PAP and improving exercise capacity on 6MWT and CPET. However     the short-term use of losartan or nifedipine had no statistically significant effect on     endothelin-1 levels in patients with PHT.   "
204087|NCT00519883|"     This is a randomized, phase III trial of a 12 week exercise program, followed by a 36 week     voluntary, self-directed exercise program (total 48 weeks) compared to standard supportive     care. The purpose of the trial is to determine whether the exercise program is better than     standard supportive care to decrease the muscle and joint aches (musculoskeletal symptoms)     that result from aromatase inhibitors.      Hypothesis An exercise program that includes stretching, strengthening and aerobic components     may improve physical quality of life among women with musculoskeletal symptoms who are taking     aromatase inhibitors.   "
204088|NCT00519896|"     This phase II trial studies how well giving sunitinib malate works in treating patients with     iodine-refractory recurrent or metastatic thyroid cancer. Sunitinib malate may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking     blood flow to the tumor   "
204089|NCT00519909|"     The overall purpose of this study is to examine the effect of calcium on fecal fat and energy     excretion.   "
204090|NCT00519922|"     This pilot study will test the testing and exercise training protocols for a larger study     that is in the desing phase and may be modified based on the findings of this study. Two     exercise groups will be compared; one is a stadard treatment group using leg strength     exercises that are commonly employed in therapy clinics. The other group will do balance and     agility type exercises, but no specific strength exercises. These KBA exercises are     increasingly common in therapy clinics, but very little research has been conducted on their     effectiveness in treating knee osteoarthritis symptoms. Participants in this study will     complete three short paper and pencil tests at the beginning and end of the study (8 weeks of     exercise) as well as a leg strength test, a leg endurance test, two short walking tests, and     a stair climb/descend test. One of the paper and pencil tests will be taken every two weeks     in an effort to see how quickly changes to symptoms might occur. The exercise programs will     be conducted 3 afternoons per week (Mon-Wed-Fri) and will be lead by an ACSM certified     instructor.   "
204091|NCT00519935|"     The protocol is a randomized clinical trial providing Multisystemic Therapy (MST), an     intensive home-based family psychotherapy intervention, to a group of urban adolescents with     poorly controlled Type 1 diabetes and their families.   "
204092|NCT00519948|"     To compare patient comfort and overall lens cleanliness with consecutive use of two     multipurpose lens solutions.   "
204093|NCT00519961|"     The purpose of this study is to validate the screening potential of NT-proBNP for the     identification of patients scheduled for vascular surgery who would benefit from additional     pre-operative cardiac testing. All patients will have NT-proBNP concentrations measured     pre-operatively. For low-intermediate risk patients only those with abnormal values will     receive further cardiac testing; all high risk patients will be referred for additional     testing.   "
204094|NCT00519974|"     RATIONALE: Learning about the reasons for choosing to have, or not to have, breast     reconstruction after mastectomy for breast cancer may help doctors understand why black or     Latina women may or may not undergo breast reconstruction.      PURPOSE: This clinical trial is studying factors affecting decisions about breast     reconstruction after mastectomy in black and Latina women.   "
204095|NCT00519987|"     This is an open label, single-center study of the pharmacokinetic and safety profile of     repeat doses of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.   "
204096|NCT00520000|"     RATIONALE: Drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle     formulation and carboplatin work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized     nanoparticle formulation together with carboplatin may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects, the best way to give, and the best     dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with     carboplatin in treating patients with advanced or metastatic solid tumors.   "
204097|NCT00520013|"     The purpose of this research study is to evaluate how patients with newly diagnosed advanced     ovarian, fallopian tube, primary peritoneal cancer and papillary serous or clear cell     mullerian tumors respond to consolidation therapy with Avastin and erlotinib or Avastin alone     over 1 year. These drugs have been used in the treatment of other types of cancers and     information from those studies suggests that these agents may help to treat the cancers     studied here.   "
204098|NCT00520026|"     The purpose of this study is to examine the proposed suicide preventive effects of lithium in     a randomized controlled trial within a group of individuals with depressive disorders. The     hypothesis being tested is that lithium treatment will significantly reduce the risk for     another suicide attempt.   "
204099|NCT00520039|"     The purpose of this study is to determine if the application of osteopathic manipulative     medicine speeds the rate of resolution of middle ear effusion (fluid) in children following     an episode of acute otitis media.   "
204100|NCT00520052|"     The aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over     one year, improves the bone mineral density in osteoporotic patients undergoing androgen     deprivation therapy for prostate cancer   "
204101|NCT00520065|"     Part A: To compare the glucose and insulin responses of a standard tube feeding product to     that of a diabetes-specific tube feeding product in individuals with type 2 diabetes.      Part B: To compare the glucose response of a standard tube feeding product to that of a     diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a     sole source of nutrition.   "
204102|NCT00520078|"     Acrochordon, or soft fibroma, is a common benign skin tumor which is generally regarded as a     sign of cutaneous aging or as a reaction to friction since it occurs in the intertriginous     areas. Recent studies have shown the presence of human papillomaviruses, especially the     mucosal types, on some of the intertriginous lesions. This study is to analyze the different     clinical presentations of acrochordon and correlate them with pathologic and molecular human     papillomavirus findings. Further goal is to improve the ability to differentiate acrochordon     and its possible prevention and treatment. Also, it may have an implication on the     transmission and prevention of cervical carcinoma.   "
204103|NCT00520091|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Celecoxib may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     chemotherapy and radiation therapy together with celecoxib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving irinotecan and cisplatin together     with radiation therapy with or without celecoxib works in treating patients with stage II,     stage III, or stage IV esophageal cancer.   "
204104|NCT00520104|"     This is an open label, single-center study to determine whether certain nasal medication     interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients     with allergic rhinitis.   "
204105|NCT00520117|"     The primary purpose of this study is to assess the psychosocial burden in women who have     experienced an abnormal pap results after screening interventions.   "
204106|NCT00520130|"     Background:      Major problems with stem cell transplantation (SCT) for cancer treatment are a lack of     suitable donors for patients without a human leukocyte-antigen (HLA) tissue-matched sibling     and graft-versus-host disease (GVHD), a serious side effects of immune-suppressing     chemotherapy that is given to bring the cancer under control before SCT. In GVHD, the     patients immune system attacks the transplanted donor cells.      This study will try to improve the results of SCT from unrelated HLA-matched donors using     targeted immune-depleting chemotherapy to bring the cancer under control before     transplantation and to lower the chance of graft rejection, followed by reduced-intensity     transplant chemotherapy to make the procedure less toxic.      Objectives:      To evaluate the safety and effectiveness of targeted immune-depleting chemotherapy followed     by reduced-intensity transplant chemotherapy in patients with advanced cancers of the blood     and immune system.      To evaluate the safety and effectiveness of two different drug combinations to prevent GVHD.     Both regimens have been successful in preventing GVHD, but they work by different mechanisms     and affect the rebuilding of the immune system after the transplant.      Eligibility:      People 18 to 74 years of age with advanced or high-risk cancers of the blood and immune     system who do not have a suitable HLA-matched sibling.      Design:      All patients receive chemotherapy before transplant to treat the cancer and suppress immune     function.      All patients receive a conditioning regimen of cyclophosphamide for 4 days and fludarabine     for 4 days before SCT to prepare for the transplant.      Patients are randomly assigned to one of two combination drug treatments to prevent GHVD as     follows:        -  Group 1: Tacrolimus starting 3 days before SCT and continuing for 6 months, plus          methotrexate on days 1, 3, 6, and 11 post-SCT, plus sirolimus starting 3 days before the          SCT and continues for 6 months following SCT.        -  Group 2: Alemtuzumab for 4 days starting 8 days before SCT, plus cyclosporine starting 1          day before SCT and continuing for 6 months.      Patients receive the donors stem cells and immune cells 2 days after completing the     conditioning regimen.      Patients are followed at the clinic regularly for the first 6 months after SCT, and then less     often for at least 5 years. Some visits may include bone marrow aspirates and biopsies, blood     draws, and other tests to monitor disease status.      A skin biopsy, oral mucosa biopsy, and saliva collection are done to study chronic GVHD.   "
204107|NCT00520143|"     Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a     critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the     body's cells to break down glycogen (a stored form of sugar) within specialized structures     called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates     and is stored in various tissues, especially heart and skeletal muscle, which prevents their     normal function. The objective of this expanded access study is to provide patients with     Pompe disease in the United States (US), access to alglucosidase alfa produced from a scaled     up manufacturing process for a limited time until production at this scale is approved for     commercial use by the Food and Drug Administration.   "
204108|NCT00520156|"     There is a well-documented but poorly understood relationship between headache disorders     (e.g. migraine, cluster headaches, awakening headaches, etc.) and sleep disorders. One     hypothesis includes an underlying disorder known as obstructive sleep apnea (OSA) with low     overnight oxygen saturations and possibly elevated carbon dioxide levels which result in     awakening headache. Bruxism, or grinding of the teeth, has also been anecdotally associated     with headache. The converse of these arguments is that the patient may have a primary     headache disorder, for example migraine, leading to disordered sleep patterns or insomnia.     The true relationship between the two, as alluded above, is unknown. The actual prevalence of     the two disorders occurring simultaneously is not known.      There have been several small, retrospective studies which have attempted to evaluate this     relationship. One of these studies evaluated those patients diagnosed with OSA who were given     the standard of care therapy - continuous positive airway pressure (CPAP) - and found that     headaches among these patients were improved after using CPAP. Again, this was a small,     retrospective study.      We propose a study whereby patients who are referred for polysomnography (PSG, or sleep     study) are consented, then surveyed on the presence or absence of headache. A brief     questionnaire is followed up with a more detailed questionnaire to characterize whether this     headache that the patient has is truly a headache disorder. Following the survey and PSG, the     patient's sleep study parameters are evaluated to see whether there are certain correlations     between what has been recorded and the particular headache disorder present.      Lastly, if the patient was diagnosed with OSA and fitted with a CPAP device, the patient will     be queried several weeks later to evaluate whether there was improvement or cessation of the     headache disorder.   "
204109|NCT00520169|"     This is an open label, single-center study to determine the absolute bioavailability and     nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.   "
204110|NCT00512941|"     Chronic hepatitis by the B virus (HBV) and/or by the C virus (HCV) is a major public-health     problem since it presents a long phase of clinical latency which makes its early diagnosis     difficult and results in the development of a large number of cases to complications such as     cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated that the     number of HBV is two million, of which 72 thousand have been reported. As regards HCV, the     ratio is one of three million estimated cases to 52 thousand reports. Learning about the     serological profile of the users of a viral hepatitis reference service is fundamental for     the planning of diagnostic and caregiving actions; therefore, it is the objective of this     study.   "
204133|NCT00513266|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, fluorouracil and     leucovorin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances     to them. Giving combination chemotherapy together with monoclonal antibody therapy may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with monoclonal antibody therapy works in treating patients with advanced colorectal cancer     with liver metastases or lung metastases that are potentially removable by surgery.   "
226484|NCT00817505|"     To evaluate the bioavailability of a tablet of AZD1656.   "
204111|NCT00512954|"     Diseases of the airways (bronchi) of the lungs include asthma and chronic obstructive     pulmonary disease (COPD), which are leading causes of reduced quality of life, loss of work,     hospital admissions and deaths and result in a major economic burden to the patient and     society. Worsening (exacerbation) of these conditions is common and is frequently due to     viral or bacterial infection, which causes inflammation in the bronchi, i.e. bronchitis. Ways     to objectively measure the inflammation are needed to improve diagnosis, cause and severity     and to guide treatment. The investigators also need to understand changes in the body's     defense (immune) mechanisms that make some patients have more frequent infective bronchitis.      At present, sputum cell counts are able to identify different types of bronchitis, their     severity and may be able to differentiate viral from bacterial infection. Other measurements     in sputum, exhaled breath, blood and urine are also available to measure this inflammation.     Measurement of immune cells in the blood gives us an idea about the working capacity of the     immune system of the body.      The investigators plan to study patients with asthma or COPD at the time of worsening of     their condition to identify,        1. To what extent viral or bacterial bronchitis can be diagnosed from tests of          inflammation?        2. How clearing of infection relates to clearing of inflammation?        3. What are the changes in the body's defense mechanisms that make a patient more prone to          frequent infective bronchitis?        4. How do the measurements in sputum, exhaled breath, blood and urine relate to viral and          bacterial bronchitis?        5. What are the differences in the measurements in sputum, exhaled breath, blood and urine          in asthma and COPD?   "
204112|NCT00512967|"     Reactive oxygen species (ROS) are suggested to play a pivotal role in ILD. Little is known,     however, about the endogenous antioxidant levels in ILD that can offer protection against     ROS. It is expected that the high amount of ROS present in ILD will reduce the antioxidant     levels. Therefore, antioxidant therapy to strengthen this reduced antioxidant defense might     be efficacious in ILD treatment. Since ROS are capable of initiating and mediating     inflammation, antioxidant therapy might also mitigate elevated inflammation. A candidate for     antioxidant therapy is the flavonoid quercetin that is known for its anti-oxidative and     anti-inflammatory capacities.      The aim of the present study is to determine the antioxidant and inflammatory status in ILD,     i.e. sarcoidosis and idiopathic pulmonary fibrosis (IPF). Furthermore, to evaluate the     possible anti-inflammatory effects of antioxidants, the effect of quercetin will be examined     on the ex vivo LPS-induced cytokine production in ILD   "
204113|NCT00512980|"     A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in     patients with intermediate stage Hodgkin's lymphoma   "
204114|NCT00512993|"     The purpose of this study is to determine the event-free survival (EFS) after zoledronic acid     for 5 years versus no postoperative treatment in patients with chemo-insensitive breast     cancer (ypT1-4 and/or ypN1-3) after preoperative anthracycline/taxane containing chemotherapy   "
204115|NCT00513019|"     The goal of the proposed study is to evaluate the comparative efficacy of Lamictal     (lamotrigine) to placebo in neurotic excoriation. Thirty subjects with neurotic excoriation     will receive 12 weeks of double-blind treatment with Lamictal (lamotrigine) or matching     placebo. The hypothesis to be tested is that Lamictal (lamotrigine) will be more effective     than placebo in patients with neurotic excoriation. The proposed study will provide needed     data on the treatment of a disabling disorder that currently lacks a clearly effective     treatment.   "
204116|NCT00513032|"     We hypothesized that pre-treatment with methylene blue could potentiate the effects of     general anaesthetic agents in patients undergoing parathyroidectomy   "
204117|NCT00513045|"     The objective of this study is to validate a newly designed self-help treatment for     nightmares. This self-help treatment is based on Imagery Rehearsal Therapy. This treatment     will be validated in comparison to an exposure treatment a diary condition and a waiting list     condition.   "
204118|NCT00513058|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving lapatinib together with vinorelbine may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and     vinorelbine in treating women with HER2-overexpressing locally advanced or metastatic breast     cancer.   "
204119|NCT00513071|"     This phase II trial is studying how well AZD0530 works in treating patients with prostate     cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth   "
204120|NCT00513084|"     The primary objectives of this randomized clinical trial are a) to implement and test the     impact of a 1-year lifestyle obesity treatment program based on Self-Determination Theory on     3-year change in physical activity and motivation for exercise/physical activity, body weight     and fat, and selected eating variables, b) to identify behavioral and psychosocial     theory-based moderators or mediators of primary outcomes, especially physical activity and     body weight.   "
204121|NCT00513097|"     Primary, secondary, and tertiary specific aims are to answer the following questions about     interactive, Internet-based tobacco control intervention directed towards 10th-graders:        1. Smoking Prevention (primary): Does the intervention result in a lower incidence of          smoking initiation compared to standard care?        2. Smoking Cessation (primary): Does the intervention result in higher rates of smoking          cessation compared to standard care?        3. Reduction of Spit Tobacco Use (secondary): Does the intervention have an impact on spit          tobacco use compared to standard care?        4. Stages of Change (tertiary): Does the intervention have an impact on progression through          the stages of smoking and spit tobacco acquisition and cessation compared to standard          care?        5. Mediating Variables (tertiary): How are mediating variables associated with tobacco-use          onset and cessation?        6. Testing Predictors: Investigate established and recently elucidated predictors of          susceptibility to smoking at baseline and 12-month follow-up.        7. Develop/Validate Spit Tobacco Measures: Investigate predictors of susceptibility of spit          tobacco use at baseline and 12-month follow-up        8. Testing Measures Across Race/Ethnicity: Explore predictors of susceptibility to smoking          at baseline and 12-month follow-up to determine whether predictors differ among White,          African-American, and Hispanic students.   "
235096|NCT00930826|"     Childhood Asthma and Schooling: The Truth Unveiled.   "
204122|NCT00513110|"     The adenosine receptor is known for its anti-inflammatory actions and could therefore be a     potential target in the treatment of sepsis and septic shock. Stimulation of the adenosine     receptor could potentially lead to a decrease in inflammation and tissue damage.      Under normal conditions adenosine is formed either by an intracellular 5`nucleotidase, which     dephosphorylates AMP, or by the hydrolysis of S-adenosylhomcysteine by hydrolase. An     alternative pathway of AMP degradations is provided by the cytosolic enzyme AMP deaminase     (AMPD), which catalyses the irreversible deamination of AMP to inosine monophosphate and     ammonia.      In humans four AMPD isoforms have been described, named after the source from which they were     initially purified; M (muscle), L (liver), E1 and E2 (erythrocyte), encoded by AMPD1, AMPD2     and AMPD3. Approximately 15-20% of Caucasian and African American individuals are     heterozygous or homozygous for the 34C>T variant of AMPD1.      We hypothesize that healthy volunteers who have the polymorphism for AMPD1 have a less severe     inflammatory response to LPS and show less (severe) organ failure. This hypothesis is based     on the expected higher levels of adenosine in patients with the AMPD1 polymorphism. This     hypothesis is strengthened by the fact that patients with coronary artery disease and the     AMPD1 polymorphism show improved cardiovascular survival (Anderson JL et al. J Am Coll     Cardiol 2000; 36: 1248-52) possibly based on higher adenosine levels by reduced AMPD     activity. Furthermore the polymorphism predicts improved clinical outcome in patients with     heart failure (Loh E et al. Circulation 1999) also based on a hypothetical elevation of     adenosine.      We hypothesize that:      The C34T-polymorphism of the enzyme AMP-deaminase leads to a decreased inflammatory respons     and thereby a decrease of LPS-induced tissue damage.      A second hypothesis is based on the antagonism of the adenosine receptor, by caffeine;      Antagonism of the adenosine receptor by caffeine leads to an increased LPS-induced     inflammatory reaction and an increase in (subclinical) tissue damage?   "
204123|NCT00513123|"     The overall objective of this study is to identify potential improvements for a noninvasive     method of diagnosing dysplasia and neoplasia in the cervix using digital colposcopy for     colposcopy for fluorescence spectroscopy.      Other Objectives:        -  To measure digital fluorescence and reflectance images in vivo of sites in the human          cervix.        -  To evaluate the effect of acetic acid in the image contrast obtained.        -  Compare the device performance to colposcopy and pathologic analysis of tissue removed          at colposcopy.   "
204124|NCT00513136|"     Thirty to forty percent of breast cancer survivors suffer from persistent fatigue lingering     months to years after adjuvant therapy is completed. Although researchers have developed some     effective interventions (exercise or group-based holistic program) to treat fatigue, none     have addressed the role of the family in the patient's long-term recovery.      The investigators hypothesize that a family-focused intervention in combination with a     mind-body group intervention will be more effective in reducing fatigue, improving quality of     life, and enhancing family relationships for breast cancer survivors than a group     intervention with an individual focus.   "
204125|NCT00513149|"     Background—Despite the pivotal pathogenic role of platelets in atherothrombosis has been     widely recognized, there is a striking lack of consensus regarding how to measure platelet     function and how to monitor the effects of various antiplatelet drugs. In view of the fact     that recurrent ischemic events occurred in 8.5% to 8.8% of patients treated with dual     antiplatelet drugs and there is significant inter-individual variability in platelet     reactivity, we believe that the importance of platelet function assessment and its clinical     implication should not be overlooked.   "
204126|NCT00513162|"     Primary Objective:        -  Determine the interindividual range and median of individual maximum tolerated doses of          valproic acid administered as one time evening dose in conjunction with a dose oral          etoposide (50 mg/m2/day for children, but only 25mg/m2/day for adults to start) for four          different age groups.      Secondary Objectives:        -  Determine the qualitative and quantitative toxicity and reversibility of toxicity of          valproic acid in conjunction with oral etoposide,        -  To investigate the clinical pharmacokinetics of valproic acid when given in conjunction          with oral etoposide,        -  To describe quality of life of patients with relapsed, or progressive central and          peripheral nervous system tumors when treated with oral valproic acid and etoposide,        -  To observe and describe the response pattern of progressive central nervous system          tumors treated with oral valproic acid and etoposide,        -  To observe and describe event free survival time and overall survival time of patients          with relapsed, or progressive central nervous system tumors when treated with oral          valproic acid and etoposide,        -  To determine if histone deacetylase activity and topoisomerase expression in lymphocytes          of patients is related to valproic acid levels, and        -  To determine, if the individual maximal tolerated dose (iMTD) depends on the initial          performance status of the patient in the beginning of the treatment.   "
204127|NCT00513175|"     The primary objective of this study is to examine transplant related mortality (TRM) at 100     days <30%. A TRM of >50% is considered unacceptable. This study also seeks a TRM at 12 months     that is <50%, engraftment >90% (defined as donor cells >80% at 6 months), and 1 year overall     survival >50%.   "
204128|NCT00513188|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Combinations of     biological substances in denileukin diftitox may be able to carry cancer-killing substances     directly to non-Hodgkin lymphoma cells. Giving combination chemotherapy together with     denileukin diftitox may kill more cancer cells.      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together     with denileukin diftitox works in treating patients with newly diagnosed T-cell non-Hodgkin     lymphoma.   "
204129|NCT00513201|"     OBJECTIVE: To compare lispro insulin and regular insulin in the glycemic control of patients     with liver cirrhosis and type 2 diabetes subjects. METHODS: 108 patients with liver cirrhosis     and type 2 diabetes were randomly treated with regular insulin or lispro. After 122 weeks a     cross-over was carried out and patients followed-up for 122 weeks. Then, all patients     received a standard breakfast of 145 kcal following 12 U.I. of regular insulin or lispro, and     C-peptide and insulin serum levels were determined over 300 minutes.   "
204130|NCT00513214|"     The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of XOMA 052 in     subjects with stable Type 2 Diabetes Mellitus (T2D).      The study is a dose-escalation study designed to evaluate route of administration     (intravenous or subcutaneous), doses, and dosing regimens for future studies.   "
204131|NCT00513240|"     Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on     neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long     term development problems such as learning disorders and hyperactivity syndromes. This study     aims to determine if erythropoetin, a natural hormone made in the body, protects the brain     from damage when given in high doses before and during neonatal open heart surgery. We will     use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental     outcome testing to see if erythropoetin is better than salt water injection (placebo) in     protecting the brain.   "
204134|NCT00513279|"     GSK618334 is being developed as an innovative treatment for substance dependence and     potentially other compulsive behavioral disorders. This study will evaluate the safety,     tolerability and pharmacokinetics of single doses of GSK618334 in healthy volunteers.   "
204135|NCT00513292|"     This randomized phase III trial is studying giving fluorouracil together with epirubicin and     cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared     with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin,     cyclophosphamide, and trastuzumab in treating women with palpable breast cancer that can be     removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. It is not yet known whether it is more effective to     give combination chemotherapy before or after treatment with paclitaxel plus trastuzumab.   "
204136|NCT00513305|"     The primary objective of this study is to determine whether low-dose cytarabine in     combination with arsenic trioxide is more effective than low-dose cytarabine alone in     achieving complete remission in elderly patients (≥60 years of age) with acute myeloid     leukemia.   "
204137|NCT00513318|"     This is a pilot study designed to evaluate the safety and feasibility of performing umbilical     cord blood transplants in older adults or younger infirm patients with high-risk     hematopoeitic malignancies. A novel reduced-intensity preparative regimen for umbilical cord     blood transplantation will be used. One to a maximum of three cord blood units, depending on     cell count, will be administered to facilitate engraftment. Ten patients will be enrolled     with an expected accrual rate of 3-4 patients per year and with a goal of completing accrual     within 2-3 years.   "
204138|NCT00513331|"     This is a study of Barrett's Esophagus (BE) and Gastroesophageal Reflux Disease (GERD). It     aims to look at the long term efficacy of evidence-based cutting edge diagnostic and     therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal     resection and surveillance endoscopy with biopsy. Additionally, biological analyses will be     performed in hopes of identifying biomarkers associated with the progression of BE to     esophageal cancer.   "
204139|NCT00513344|"     Dark chocolate is one of the richest sources of polyphenols though it has been hypothesised     that the bioavailability and therefore probably the bioefficacy of epicatechin from milk     chocolate was reduced compared to dark. This study is designed to compare milk and dark     chocolate as a source of polyphenols with a control chocolate for improving a risk     biomarker for vascular disease.   "
204140|NCT00513357|"     The goal of this clinical research study is to evaluate the effectiveness of melatonin for     the management of poor appetite and weight loss in advanced cancer patients. The     effectiveness of melatonin on weight gain, keeping/gaining of lean muscle mass, improved     appetite, and side effects will also be evaluated.   "
204141|NCT00513370|"     To evaluate the safety profile, the effectiveness and the economic impact of adalimumab when     used for the treatment of subjects with active plaque psoriasis who have not adequately     responded to prior psoriasis therapy.   "
204142|NCT00513383|"     This study is being done to test whether panitumumab, in combination with chemotherapy and     radiation is safe in people with head and neck cancer. Another goal of this study is to find     the highest dose of the study drugs that can be given safely without causing serious sife     effects. Panitumumab is a type of drug called a monoclonal antibody that has been studied in     other types of cancers, such as kidney and colon. This monoclonal antibody is directed     against the epidermal growth factor receptor (EGFR). EGFR has been found on the majority of     head and neck cancer cells. By blocking EGFR, this monoclonal antibody may inhibit the growth     of head and neck cancer cells.   "
204143|NCT00513396|"     The need for a standardized treatment protocol for multidrug resistant tuberculosis (MDR-TB)     in resource-limited countries is being increasingly recognized. This single center, double     blind, randomized controlled trial was designed to compare the time required for sputum     culture conversion and extent of radiological improvement in cases of MDR pulmonary     tuberculosis when isoniazid was included (both at a regular dose and at a high dose) as an     adjuvant to the standardized second line of treatment. The study was designed to test the     hypothesis that inclusion of high-dose isoniazid will enhance the effectiveness of the second     line of treatment in cases of MDR-TB without significantly increasing the toxicity.   "
204144|NCT00513409|"     This is a booster study in 2 groups of healthy children less than 3 years old to measure the     reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine,     when given as a booster or as a two-dose catch-up vaccination.      This protocol posting deals with objectives and outcome measures of the booster phase. The     objectives and outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT00338351).   "
204145|NCT00513422|"     The primary aim of this study is to determine if the dietary supplements, glucosamine     sulphate and/or chondroitin can limit or reduce structural disease progression whilst     providing symptomatic benefit in people with osteoarthritis (OA) of the knee.      The specific hypotheses to be tested in the proposed double blind, placebo-controlled,     randomised clinical trial are that, compared to participants allocated to placebo,     participants allocated to either or both of these dietary supplements will demonstrate:        -  reduced medial tibio-femoral joint space narrowing at 2 years AND;        -  reduced knee pain over 1 year      These benefits will be achieved by participants allocated to glucosamine sulphate and/or     chondroitin (the study treatments) without concomitant:        -  increased use of analgesics        -  reduced health-related quality of life        -  reduced participation in leisure-time physical activity   "
204146|NCT00513435|"     This phase II trial is studying the how well saracatinib works in treating patients with     metastatic or recurrent head and neck cancer. Saracatinib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth   "
204147|NCT00513448|"     The purpose of this study was to determine whether a group wellness intervention or     individualized physical rehabilitation was more effective in improving health and physical     activity in persons with multiple sclerosis.   "
204162|NCT00513643|"     The metabolic effect of three different doses of insulin aspart and human insulin are     investigated with the euglycaemic glucose clamp technique.   "
204148|NCT00513461|"     This randomized phase II trial studies how well S-Adenosyl-L-Methionine Disulphate     P-Toluene-Sulfonate (SAMe) works compared to a placebo in preventing liver cancer in patients     with chronic hepatitis C infection. Chemoprevention is the use of certain drugs to keep     cancer from forming. The use of SAMe may keep cancer from forming in patients with advanced     liver disease   "
204149|NCT00513474|"     RATIONALE: Rasburicase may be an effective treatment for graft-versus-host disease caused by     a donor stem cell transplant.      PURPOSE: This clinical trial is studying how well rasburicase works in preventing     graft-versus-host disease in patients with hematologic cancer or other disease undergoing     donor stem cell transplant.   "
204150|NCT00513487|"     This study will evaluate whether multiple nasal antigen challenges with dust mite allergen     produces increases in nasal symptoms and local allergic inflammatory cells in the nose and     the blood.   "
204151|NCT00513500|"     The purpose of the study is to demonstrate the effectiveness and feasibility of     community-based management of pneumonia and malaria by community health workers (CHWs) in a     rural district of Zambia.   "
204152|NCT00513513|"     This is an open label study (no placebos are used; all patients will receive the true     medication) to evaluate the effectiveness of TMC114/rtv in treatment naÃ-ve (never previously     received anti-HIV drugs), HIV 1 infected patients.   "
204153|NCT00513526|"     RATIONALE: Vaccines made from human papillomavirus may help the body build an effective     immune response to kill HIV cells.      PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus     vaccine therapy works in treating men with HIV-1 infection.   "
204154|NCT00513539|"     RATIONALE: Biliary stenting is the placement of a tube in the bile ducts to keep a blocked     area open. Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by     tumor cells. The drug becomes active when it is exposed to light. When the drug is active,     tumor cells are killed. It is not yet known whether biliary stenting is more effective with     or without photodynamic therapy in treating patients with biliary tract tumors.      PURPOSE: This randomized phase III trial is studying biliary stenting to see how well it     works compared with biliary stenting and photodynamic therapy using porfimer sodium in     treating patients with locally advanced, recurrent, or metastatic cholangiocarcinoma or other     biliary tract tumors that cannot be removed by surgery.   "
204155|NCT00513552|"     Crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract. The origin     of Crohn's disease remains unknown and there is no curative therapy, either medical or     surgical, for this gut disorder.      It is believed that an infectious agent is important in the development of Crohn's disease.     The similarity of Crohn's disease to the animal form of ileitis, termed Johne's disease,     supports the possibility that both disorders are caused by exposure to Mycobacterium avium     paratuberculosis or MAP. Multiple investigators have demonstrated good clinical responses of     patients with Crohn's disease to treatment with triple antibiotic therapy directed against     mycobacterial infection.      The hypothesis of this protocol is that triple antibiotic therapy is useful as a medical     therapy for patients with Crohn's disease. The aim of this study is to examine the response     of patients with Crohn's disease who are not receiving therapy with biological agents to     triple antibiotic therapy.   "
204156|NCT00513565|"     This study will be conducted in healthy volunteers to investigate the effect of single dose     GSK561679 on the changes of brain activation, as it compares to an active comparator,     lorazepam.   "
204157|NCT00513578|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of     white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine     therapy together with GM-CSF may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF     works in treating patients with low-risk or intermediate-risk myelodysplastic syndrome.   "
204158|NCT00513591|"     It is difficult to predict how a women with an autoimmune disease will do during pregnancy.     Some women will improve, others will worsen. Some pregnancies progress normally and others     become very complicated.      The Duke Autoimmunity in Pregnancy (DAP) Registry will enroll women with autoimmune diseases,     such as lupus, rheumatoid arthritis, scleroderma, and Sjogren's syndrome who wish to become,     or already are, pregnant. We will follow these women throughout pregnancy to better     understand how their autoimmune disease affects their pregnancy, and vice versa.   "
204159|NCT00513604|"     Background:        -  Most therapeutic therapies for metastatic melanoma have focused on the ability of T-cell          lymphocytes to kill cells of tumors.        -  An adaptive cell transfer therapy has been pioneered, in which cells are grown for a          short time in the laboratory. The way they are grown may have a better effect in a          patient's body than do other cells that are cultured for a longer time.      Objectives:        -  To determine whether tumor-infiltrating lymphocytes (TIL) can be put in cells removed          from patients' tumors or blood and then reinfused, with the purpose of shrinking tumors.        -  To evaluate safety and effectiveness of the treatment.      Eligibility:        -  Patients 18 years of age or older with metastatic cancer melanoma (cancer that has          spread beyond the original site).        -  Patient's leukocyte antigen type is human leukocyte antigens (HLA-A) 0201.      Design:      -Patients undergo the following procedures:        -  Leukapheresis (on two occasions). This is a method of collecting large numbers of white          blood cells. The cells obtained in the first leukapheresis procedure are grown in the          laboratory, and the TIL cells (called young TIL cells) are inserted into the cells using          an inactivated (harmless) virus in a process called retroviral transduction. Cells          collected in the second leukapheresis procedure are used to evaluate the effectiveness          of the study treatment.        -  Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1          hour for 2 days to suppress the immune system so that the patient's immune cells do not          interfere with the treatment.        -  Treatment with young TIL cells. Patients receive an IV infusion of the treated cells,          followed by infusions the drug aldesleukin-2 (IL-2), which helps boost the effectiveness          of the treated white cells.        -  Patients are given support medications to prevent complications such as infections.        -  Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue).        -  Patients are evaluated with laboratory tests and imaging tests, such as computed          tomography (CT) scans, 4 to 6 weeks after treatment and then once a month for 3 to 4          months to determine the response to treatment.        -  Patients have blood tests at 3, 6, and 12 months and then annually for 5 years.   "
204160|NCT00513617|"     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited genetic disease     that can cause intense pain episodes. This study will evaluate the effectiveness of the     nutritional supplement arginine at improving blood cell function and disease symptoms in     people with SCD.   "
204161|NCT00513630|"     The purpose of this study is to explore the recurrence risk of cardiovascular events in     patients with type 2 diabetes mellitus and coronary heart disease after different     antidiabetic drug therapy (glipizide or metformin) by using an double-blind, randomized,     parallel control and prospective study      The end point of this study is:        1. follow up 3yr        2. recurrence of cardiovascular event        3. death caused by other reasons such as stroke, uremia, blindness and amputation   "
204164|NCT00513669|"     This is a phase Ib double-blind randomized placebo controlled age-deescalating trial to     assess sagety and immunogenicity of two virosome formulated anti-malaria vaccine components     (PEV 301 and PEV 302) administered in combination to healthy semi-immune Tanzanian adult and     children.   "
204165|NCT00513682|"     This is a Phase III, multicenter, open-label study, that will evaluate the improvement of     nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by     Aptalis (formerly Axcan). This study is performed in children from 7 to 11 years old.   "
204166|NCT00513695|"     This phase II trial studies how well giving sunitinib malate together with paclitaxel,     doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients     with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.     Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving sunitinib malate together with     combination chemotherapy before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed   "
204167|NCT00513708|"     The purpose of this study is to determine whether peer visits (known as 12th Step Calls)     and professional counselors (using Motivational Enhancement Therapy) are effective helping     alcoholics link to substance abuse treatment programs after being in the hospital for detox.   "
204168|NCT00520182|"     Obese patients with type 2 diabetes often fail to loose weight and thus do not succeed in     improving their sugar and lipid profiles and remain at high risk for diabetes complications      The study enrolled 259 obese diabetic patients attending HMO clinics in central Israel. Over     a 6 month period the participants met with a dietitian every fortnight and attended group     lectures every 2 months.      The objective of this intervention was to compare three dietary intervention along with close     monitoring of the patients by dietitians, regarding blood lipid and sugar balance as well as     weight loss. The three diets are the American Diabetes Association (ADA) diet from 2003; a     diet containing low glycemic index carbohydrate otherwise similar to the ADA diet; and a low     glycemic index diet with more fat than the other 2 diets with high proportion of     mono-unsaturated fatty acids.      Patients were individually randomized to receive one of the three diets. Among the measures     obtained every 3 months for the first year and every 6 months thereafter are weight, fasting     insulin and glucose, glycosylated hemoglobin, blood and urine chemistry profiles and lipid     profile.   "
204169|NCT00520195|"     This is an intervention study which evaluates the cardiovascular primary preventive effects     of using stairs instead of elevators at the worksite during a 12-weeks period. We hypothesize     that stair-climbing during working hours can meet the daily amount of physical activity     recommended by current public health guidelines.   "
204170|NCT00520208|"     This is a Phase II, open-label, non-randomized study to evaluate the safety, efficacy, and     pharmacokinetics of tamibarotene in adult patients with relapsed or refractory acute     promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and     arsenic trioxide (ATO). Patients must have received and failed therapy with ATRA and ATO.     Treatment may have been administered either as combination therapy or sequentially as single     agents. Patients who are intolerant to either drug are eligible for this study.   "
204171|NCT00520221|"     The optimal initial management of primary spontaneous pneumothorax (PSP) remains     controversial. This study was conducted to evaluate the safety and efficacy of additional     minocycline pleurodesis after successful aspiration of the first episode of PSP.   "
204172|NCT00520234|"     Adults admitted to intensive care units are at risk for a variety of complications.     Infections due to the fungus called candida are of particular concern. The study will test     the possibility that caspofungin, a new therapy for fungal infections, can successfully     reduce the rate of candida infections in subjects at risk. It will also test if caspofungin     is useful in treating subjects for this disease when diagnosed using a new blood test that is     performed twice weekly, permitting earlier diagnosis than current practice standards.   "
204173|NCT00520247|"     Combinded therapy with folic acid and enalapril may significantly decrease plasma total     homocysteine level and had beneficial effect on blood pressure reduction and glycometabolism.   "
204174|NCT00520260|"     To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine     ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of     treatment for chronic dry eye disease   "
204175|NCT00520273|"     This study will evaluate the specificity of the cobas TaqScreen MPX Test for the simultaneous     detection of HBV DNA, HCV RNA and HIV-1 Group M in a minimum of 100,000 individual donor     samples in 96-unit pools.   "
204176|NCT00520286|"     The purpose of this study will be to examine the safety and efficacy of modafinil in     increasing number of methamphetamine non-use weeks in subjects with methamphetamine     dependence.   "
204177|NCT00520299|"     This was a phase 1/2, open-label, dose-escalation study of arginine deiminase linked via     succinimidyl succinate to polyethylene glycol of 20,000 molecular weight (ADI-PEG 20) in     subjects with advanced melanoma. ADI-PEG 20 was administered intramuscularly (IM) at     escalating doses weekly for 9 weeks (cycle 1) or 8 weeks (subsequent cycles). The primary     objectives were to the establish the safety, tolerability, and clinical efficacy of ADI-PEG     20. Secondary objectives included evaluation of the metabolic activity by     [18F]-fluorodeoxyglucose positron emission tomography (FDG PET), pharmacodynamics,     correlation of immunogenicity with clinical response, and correlation of argininosuccinate     synthetase (ASS) tumor expression with clinical response.   "
204178|NCT00520312|"     Peripheral arterial disease (PAD) is a disease in which fatty build-up, or plaque,     accumulates in the peripheral arteries. People with PAD often experience leg pain while     walking due to reduced blood flow to the legs. This study will use magnetic resonance imaging     (MRI) techniques to examine how specific features of plaque build-up in the leg arteries     affect walking ability, leg strength, and balance in people with PAD.   "
204179|NCT00520325|"     The goal of this clinical research study is to find the dose of EZN-2232 that can be given to     MBL deficient pediatric cancer patients undergoing chemotherapy. The pharmacokinetics,     pharmacodynamics, and safety of the study drug will also be studied.   "
234815|NCT00921141|"     This is a prospective, descriptive and observational study of the anticancer center practice   "
204180|NCT00520338|"     The purpose of this study is to determine whether celecoxib is effective in the treatment     postoperative pain after thyroidectomy.      The research hypothesis:      There is a difference in postoperative morphine consumption in the first 24 hours after     thyroidectomy between patients who received celecoxib or placebo.   "
204181|NCT00520351|"     The purpose of the study is to evaluate and compare, on a daily wear basis, the performance     of two contact lens care solutions when used with silicone hydrogel soft contact lenses with     regards to comfort and dryness symptoms.   "
204182|NCT00520364|"     Objective: Chemotherapy regimens containing alkylating agents result in primordial follicle     death and premature ovarian failure. Depending on the age and the type/dose of chemotherapy,     some women may continue to menstruate. Our aim was to ascertain the impact of chemotherapy on     ovarian reserve in patients who previously received chemotherapy by response to controlled     ovarian hyper stimulation (COH) and anti-mullerian hormone (AMH) levels. Design: Prospective     study with retrospective controls Materials and Methods: 45 cancer patients underwent     controlled ovarian stimulation for IVF before (30 patients, 30 IVF cycles) or after (15     patients, 30 IVF cycles) chemotherapy. Patients with basal serum FSH >13mIU/mL or E2>70pg/ml     were excluded. AMH was measured on previously stored serum samples from the day of initiation     of the ovarian stimulation. Results: Mean ages and baseline FSH levels of pre- and     postchemotherapy IVF patients were similar (36.8±0.91 vs. 36.3±1). The mean interval from     completion of chemotherapy to IVF was 8.03±1.32 years (range 1-23). Of the 30 IVF cycles in     post-chemotherapy patients, 22 received alkylating agents and 8 did not.      There were no significant differences between the study and control cycles regarding day-2     estradiol (E2), length of stimulation, total gonadotropin dose, and E2 on hCG day (table 2).     Cycle cancellation rate was 20% and 26.67% for pre and post-chemotherapy patients,     respectively. The number of oocytes retrieved and fertilized were significantly higher in     pre-chemotherapy group (p<0.0001). Two clinical pregnancies were achieved in the     postchemotherapy group, one ending in spontaneous abortion and the other in the delivery of a     healthy baby (6.67% clinical pregnancy rate and 3.33% delivery rate per attempted cycle). All     fertilized oocytes in the control group were cryopreserved at 2-pronuclei stage.      Baseline AMH levels were significantly lower in post chemotherapy IVF patients compared to     those who underwent IVF prior to chemotherapy (0.270 ±0.077 vs. 0.84±0.27 ng/ml, p=0.03). In     the pre-chemotherapy group there was a positive correlation between the AMH levels and the     number of oocytes retrieved (r=0.663, p=0.004 ). This correlation was not detected in the     post chemotherapy group (r=0.205).   "
204183|NCT00520377|"     The primary objective is the area of newly formed bone (%) as assessed by histomorphometry     with either MD05 or beta-TCP.   "
204184|NCT00520390|"     The goal of this clinical research study is to find the highest tolerable dose of EZN-2208     that can be given to patients with advanced cancer or lymphoma. The safety of the study drug     and its effect on the disease will also be studied.      Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the     amount of a drug in the body at different time points.   "
204185|NCT00520403|"     This single arm study will assess the efficacy and safety of Avastin in combination with     interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal     cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3     times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3     weeks. The anticipated time on study treatment is until tumor progression, and the target     sample size is 100-500 individuals.   "
204186|NCT00520416|"     Endovascular repair of infrarenal abdominal aortic aneurysms (AAA) requires a contrast agent     to identify the vascular anatomy and placement of the stent graft. Iodine contrast has     traditionally been used, but has the potential to harm the kidneys. Another contrast agent is     carbon dioxide gas. It has been proven safe to use, but the quality of the images it creates     needs to be compared to iodine contrast. Patients in this study undergo the endovascular AAA     repair as they normally, with the iodine contrast. At the end of surgery carbon dioxide gas     contrast is given as an extra step. The images will be later evaluated.   "
204187|NCT00520429|"     The primary objective of this research is to pilot test a brief mental heath treatment     specifically tailored to meet the needs of chronically ill patients with anxiety and/or     depression. Using an open-trial format, the proposed study will examine the feasibility of a     brief psychosocial intervention. Primary outcomes will assess intervention effects on patient     and clinician rated symptoms of anxiety and depression. If proven feasible and effective     among this group of participants, the intervention (due to its brief format and focus on     medically ill patient needs) will possess unique characteristics that will increase the     ability of medical care settings to implement mental health treatments, and will provide     valuable pilot data for the development of a larger research project to determine the     efficacy of this intervention among a larger group of chronically ill patients relative to     usual care.   "
204188|NCT00520442|"     A clinical trial comparing ibuprofen and acetaminophen with codeine for children after     discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more     effective analgesia compared to acetaminophen with codeine in children with uncomplicated     forearm fractures.   "
204189|NCT00520455|"     The purpose of this trial is to determine whether providing non-contracepting women with     gonorrhea or chlamydial infection with advanced provision emergency contraception (APEC) and     condoms decreases their risk of becoming pregnant.   "
204190|NCT00520468|"     Objectives:      Primary: To evaluate the response rate of total cytokine-immunotherapy for low-risk     myelodysplastic syndromes (MDS).      Secondary: To evaluate response duration, survival and side effects of the treatment.   "
204191|NCT00520481|"     This single arm, multicenter, open-label, phase II study will enroll chemotherapy-naive     patients with metastatic, histologically-confirmed adenocarcinoma of the prostate (stage M1     D2). Treatment will continue until there evidence of disease progression, intolerable     toxicity, or other withdrawal criteria are met. Non-surgically castrated patients must     continue the use of LHRH agonists during protocol treatment.   "
204192|NCT00520494|"     The objective of this study is to assess the efficacy and safety of Vivaglobin in previously     untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation     period. The purpose is to investigate whether PUPs will respond to subcutaneous     immunoglobulin (SCIG) treatment with adequate trough levels without first receiving     immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg     body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of     500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG     therapy.   "
204233|NCT00522977|"     The purpose of this echocardiographic study is to restudy the longitudinal changes in cardiac     size and function during and after pregnancy in healthy women using relatively new parameters     of systolic and diastolic function as well as classical measures of left ventricle (LV)     function using contemporary echocardiographic machines.      We, the researchers at Hillel Yaffe Medical Center, will assess diastolic function and its     possible relation to shortness of breath.   "
204193|NCT00520507|"     OBJECTIVES:      Primary Objective:      To assess the objective (polysomnographic) changes in sleep quality before and after     introduction of olanzapine in treatment of patients with depression.      Secondary Objectives:      To assess the subjective changes in sleep quality parameters before and at different stages     after introduction of olanzapine in treatment, longitudinally, and to correlate these changes     with measures of illness severity and changes in cognition.      STUDY DESIGN:      Prospective, double blind, randomized polysomnographic (PSG) study of patients before and     after treatment with olanzapine.      PSG recordings will be done three times throughout the study: before starting olanzapine     augmentation (baseline), at day 3 to 5 (acute) and day 28 to 31 (chronic). PSG will be     completed at patients' homes with a portable PSG. Psychiatric scales, subjective sleep     quality scales, and cognition measurements will be completed at each visit.   "
204194|NCT00522457|"     This study has the purpose to demonstrate clinical efficacy of the investigational new drug     ertumaxomab in patients with human epidermal growth factor receptor-2 (HER-2/neu)     overexpressing (3+ or 2+ with a positive Fluorescence In Situ Hybridization (FISH) test     result) metastatic breast cancer progressing after trastuzumab treatment.      Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu on tumor cells and CD3     on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy.     This new antibody class has the capability to redirect T cells and accessory immune effector     cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor     site. According to preclinical data, trifunctional antibodies activate these immune cells,     which can trigger a complex anti-tumor immune response.   "
204195|NCT00522470|"     We aimed to evaluate the effects of rosiglitazone on serum ghrelin and peptide yy levels in     diabetic women.   "
204196|NCT00522496|"     The purpose of this study is to:        1. Determine the temporal course of matrix metalloproteinase (MMP) expression in patients          wiht severe traumatic brain injury        2. Determine the temporal course of the expression of MMP-related inflammatory mediators of          secondary injury in patients with severe traumatic brain injury        3. Describe the association of physiological changes and standard microdialysis analyte          measures (lactate, pyruvate, lactate/pyruvate ratio, and glucose) to MMP and          neuroinflammatory marker concentrations.   "
204197|NCT00522509|"     To assess the feasibility and results of liver resection after preoperative hepatic artery     infusion (HAI) chemotherapy with FUDR.   "
204198|NCT00522522|"     Naturalistic, multicentre, epidemiological study to evaluate the care services used during     the process of diagnosis of any kind of epilepsy. Data about services since first seizure     until confirmed diagnosis will be examined.   "
204199|NCT00522535|"     Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness     of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of     abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled     aorta, angled aneurysmal body, or both, between 0° and 90°.      Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free     from endoleak, migration, and fracture at 12 months.      Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to     the 12 month, all cause mortality rate in the Open Control group.      Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the     Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30     days post-operative in the Open Control group.   "
204200|NCT00522548|"     Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness     to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients.     However, Myfortic has been thought to possibly be associated with fewer gastrointestinal side     effects. CellCept and Myfortic pharmacokinetics (how the drug is absorbed and broken down)     have not been well-studied in African American kidney transplant recipients. The     investigators are interested in studying Myfortic and CellCept pharmacokinetics and     gastrointestinal side effects in African American kidney transplant recipients.   "
204201|NCT00522561|"     Inter-individual variability in energetic cost of running may be partly explained by lower     limbs mechanical characteristics. The transposition of muscle mechanical model with two     components (contractile and elastic) to the whole lower limb mechanical behavior analysis     during running. The main aim of present investigation is to study the effects of lower limb     mechanical characteristic (force, velocity, stiffness) on the energetic cost of running using     a lower limb mechanical approach including both contractile and elastic components.Twenty     healthy men will run on a treadmill at 12km.h-1 in 8 different 5 min-conditions. Through     conditions, stride frequency, sole stiffness and subject's body weight will be changed to     allow artificial variations in lower limb mechanical characteristics. Energetic and     non-invasive mechanical measurements analysis will be performed to obtain energetic cost of     running and to compute force, velocity and stiffness of lower limbs for each condition.   "
204202|NCT00522574|"     The purpose of this study is to evaluate the safety and tolerability of XL019 in adults with     myelofibrosis. XL019 is a selective inhibitor of the cytoplasmic tyrosine kinase JAK2. JAK2     is activated by cytokine and growth factor receptors and phosphorylates members of the STAT     family of inducible transcription factors. Activation of the JAK/STAT pathway promotes cell     growth and survival, and is a common feature of human tumors. JAK2 is activated by mutation     in the majority of patients with myelofibrosis, polycythemia vera and essential     thrombocytosis and appears to drive the inappropriate growth of blood cells in these     conditions.   "
204203|NCT00522587|"     During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will     be studied.   "
204204|NCT00522600|"     This study will be used to evaluate how patients put eye drops in their eyes and any problems     that may arise from this activity. The information gathered will help identify common     problems patients are having with putting in their eye medications. Then doctors can be     better informed about the issues and provide better advice to their patients to overcome     these problems.   "
204205|NCT00522613|"     The purpose of this study is to develop and evaluate a low-cost, joint     consumer/counselor-led, health education and support intervention that will foster self-care     and recovery among adults with serious mental illness. Results from the study will indicate     how well the workbook and the overall program were received by individuals with serious     mental illness, and whether participating in the program appeared to improve recovery and     functioning.   "
204206|NCT00522626|"     This study seeks to elucidate fetal neurobehavioral development in fetuses of opioid     dependent women who have either undergone and completed methadone detoxification,or who never     received methadone maintenance, and are not methadone maintained at 36 weeks gestation. This     research will determine how fetal neurobehavioral functioning in fetuses of opioid dependent,     non-methadone maintained women differs from that of fetuses whose opioid dependent mothers     are methadone maintained. The project will utilize a state-of-the-art computerized fetal     actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart     rate, the interaction between the two and maternal physiologic parameters.   "
204207|NCT00522639|"     The objective of the study is to investigate the evolution ofn 18F-deoxyglucose (FDG) uptake     and the tumour characteristics determined in the plasma of patients with lung cancer of     during and after concurrent radiotherapy and chemotherapy   "
204208|NCT00522652|"     This study is being conducted to determine the safety and biologic activity of PX-478, and to     allow for observation of any preliminary evidence of antitumor activity in patients with     advanced metastatic cancer.   "
204209|NCT00522665|"     The addition of RAD001, an mTOR inhibitor, to irinotecan and anti-EGFR antibody cetuximab may     increase efficacy for patients with metastatic colorectal cancer who progressed on prior     chemotherapy. This approach is biologically directed to overall target the cancer cell at     multiple levels, and potentially preventing chemotherapy and EGFR-therapy resistance.   "
204210|NCT00522678|"     GW685698X is a novel glucocorticoid receptor agonist that is being developed as an orally     inhaled treatment for asthma. In previous studies inhaled GW685698X was administered as a dry     powder containing either lactose alone or lactose and cellobiose octaacetate. However, future     dry powder GW685698X formulations will contain lactose and magnesium stearate. This study     will be the first administration of this new GW685698X dry powder formulation in man and will     provide safety and tolerability data to support the further development of this formulation.   "
204211|NCT00522691|"     Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe fecal     incontinence. The test stimulation is minimally invasive, associated to low morbidity and     relatively cheap. On the contrary, implantation of the definite stimulator is related to     higher morbidity and considerable costs. A careful patent selection for definite implantation     is therefore crucial. However, indication for implantation is actually based only on the     subjective criteria reported in the patients´ diary only. Patients and care providers are     likely to overestimate the real effect of SNS leading to an unjustified overuse of this     expensive device. It is therefore necessary to evaluate real efficacy of SNS during the     testing phase in a unbiased setting in order to avoid unnecessary morbidity and costs.   "
204212|NCT00522704|"     The purpose of this study is to determine if Effective Extracorporeal Blood Flow(eEBF) has     correlation with Access Blood Flow (Qa), when eEBF adjusts with Dynamic Arterial Line     Pressure (DALP) in patients with Arteriovenous fistulae in hemodialysis treatment.   "
204213|NCT00522717|"     Patients recovering from coronary artery bypass graft (CABG) surgery have high rates of     depression, and depression is associated with higher risk of complications and death. Recent     discoveries show that depression involves changes in certain molecules in the blood, which     are also involved in progressive coronary artery disease (CAD) and its complications. This     study will evaluate the effects of cognitive behavioral therapy (CBT) as a treatment for     depression on these biological markers among CABG patients.   "
204214|NCT00522730|"     The purpose of the study is to determine the tolerance on lipid metabolism and the safety of     short-term parenteral nutrition as compared to enteral nutrition in critically ill patients     with liver failure.   "
204215|NCT00522743|"     A 2-arms randomized open prospective intervention study to determine the Growth and metabolic     response to growth hormone and gonadotropin-releasing hormone agonist treatment versus growth     hormone alone in boys born SGA.      All subjects will be treated with NorditropinSimplex at a dosage of 100mcg/kg/d.      At onset of puberty, subjects will be randomized into either combined treatment with GH and     GnRHa or GH alone.   "
204216|NCT00522756|"     The purpose of this study is to determine whether sodium bicarbonate is effective in reducing     kidney injury that may occur during cardiac surgery.   "
204217|NCT00522769|"     The claire project is a research study testing the use of Cognitive Behavioral Therapy (CBT)     to help teenage girls develop healthier eating habits and better ways to manage weight and     shape concerns. The study is enrolling girls who are members of the Kaiser Permanente Health     plan in the Northwest region. They must be between the ages of 12 and 18 and report binge     eating and/or purging (vomiting, laxative or diuretic use) at a research established     threshold to be eligible for the study. Girls enrolled in the study will either receive the     6-20 session CBT intervention at the time of enrollment or 6 months after they enroll.     Assessments including questions about eating behaviors, mood, and general functioning are     given on enrollment in the study, and 3- and 6-months following enrollment (also at 9- and     12-months for those in the delayed treatment condition).   "
204218|NCT00522782|"     To study the improvement in airway inflammation in children with asthma non-invasively with     exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg     daily.   "
204219|NCT00522795|"     Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal     Cancer: A Phase II Trial. (CTI#X64001   "
204220|NCT00522808|"     The purposes of this study are:        -  to determine the safety and tolerability of multiple doses of A-831 at various doses        -  to determine how multiple doses of A-831 are distributed through the bloodstream        -  to determine if A-831 reduces the amount of Hepatitis C virus in the blood   "
204221|NCT00522821|"     There is no consensus on the treatment of patients with recurrent infections and isolated     immunoglobulin G (IgG)-subclass deficiency and/or selective antipolysaccharide antibody     deficiency. Therefore, the Dutch Inter University Working Party will start a study in which     the treatment with antibiotics is compared with intravenous immunoglobulin therapy with     respect to clinical outcome measures in both children and adults with this disorder.   "
204244|NCT00523120|"     Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single     drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption     of oral analgesia.   "
243099|NCT01038843|"     To investigate the effect of VA106483 on nocturia related clinical outcomes compared to     placebo.   "
204222|NCT00522834|"     Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical     entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This     response is characterized by increased production of gene families that protect against     different cellular stresses, including excessive heat, the presence of reactive oxygen     species such as oxygen radicals, or the presence of heavy metals.      Subjects will participate in up to 2 weeks of screening during which time they will complete     all screening procedures. Eligible subjects who have not received any prior cytotoxic     chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either     STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone.      One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest     period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments     will be performed every 8 weeks from the date of randomization or sooner if the Investigator     suspects progression has occurred based on clinical signs and symptoms.    "
204223|NCT00522847|"     The purpose of this study is to compare various symptoms and signs of dry-eye as well as     stratify characteristics of the tear film in a group of dry-eyed individuals in comparison to     a group of non-dry-eyed people. Dry-eye is a condition that significantly impacts the quality     of life of the sufferer. These are people who are predominantly female and in the older age     groups. Determining what characterises a person with dry-eyes is of importance to     understanding the disease process.   "
204224|NCT00522860|"     Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by     Chlamydia trachomatis causes in-turning of the eyelids / lashes (trichiasis), leading to     corneal damage and blindness. The WHO recommends corrective eyelid surgery for trichiasis.     Unfortunately, trichiasis frequently returns following surgery. The purpose of this study is     to compare the outcome of surgery (at one and two years) for trichiasis using two currently     used alternative suture types: non-absorbable (silk) and absorbable (vicryl). We, the     researchers, hypothesise that the supportive presence of the absorbable suture for a longer     period produces more stable wound healing, leading to a better outcome.   "
204225|NCT00522873|"     The study is designed to investigate the safety of the investigational product for the lining     of the uterus (endometrium).   "
204226|NCT00522886|"     To determine the MTD toxicity of standard dose cetuximab together with concurrent     individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine   "
204227|NCT00522899|"     The primary objective of this study is to conduct a randomized, controlled trial to determine     whether engaging in mental activity or exercise, either alone or in combination, improves     cognitive function in non-demented, inactive older adults who self-report a recent decline in     memory or thinking. In addition, we, the researchers at the University of California, San     Francisco, plan to seek funding to follow subjects over time to determine whether these     interventions are associated with changes in rate of cognitive decline or risk of dementia     after the intervention period has ended.   "
204228|NCT00522912|"     Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by     Chlamydia trachomatis causes a gradual scarring process of the inner surface of the eyelid     (conjunctiva) leading to in-turning of the eyelids (entropion) and lashes touching the eye     (trichiasis). The rate of progression and the severity of disease are variable. Some people     develop severe disease with extensive entropion and trichiasis, whilst others have a mild     problem with only a few lashes touching the eye, which does not progress.      In more advanced cases there is a broad consensus that the entropion / trichiasis should be     corrected by surgery. In mild cases (minor trichiasis: 1-5 lashes touching the eye) the     optimal treatment is uncertain. Some advocate early surgery to turn the eyelid out for any     individual with one or more lashes touching any part of the eye. Others consider this to be     too early for surgical intervention, as surgery can have a high recurrence rate and     complications can arise. Instead, they recommend that minor trichiasis can be managed by     epilation (pulling out lashes with forceps). In many endemic regions the uptake of surgery is     low, with many patients preferring to epilate for mild disease.      The primary purpose of this study is to compare the outcome of immediate surgery to regular     epilation for the management of minor trichiasis. The epilation would be done by a person     with good eyesight using proper epilation forceps.   "
204229|NCT00522925|"     The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and     to see how safe PS433540 is compared to placebo.   "
204230|NCT00522938|"     This is an open-label, multicenter, multiple-dose, Phase I-II study of CHR-2797     co-administered with erlotinib in patients with histologically or pathologically confirmed     Stage IIIB (with pleural effusion), Stage IV, or recurrent metastatic NSCLC. Throughout this     protocol, study medication includes both CHR-2797 and erlotinib.      This study will involve 2 distinct study phases. Study Phase A will assess safety and     determine the MTD of the combination of CHR-2797 and erlotinib. In addition, PK profiles for     the combination of CHR-2797 and erlotinib will be evaluated. In Study Phase B, the dose     chosen based on the maximum tolerated dose established in Study Phase A will be administered     in a single-arm treatment design in order to evaluate the efficacy of co-administration of     CHR-2797 and erlotinib.   "
204231|NCT00522951|"     This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance,     which has already been approved as a pharmaceutical product of similar indication.   "
204232|NCT00522964|"     A randomized study is proposed to determine effects of 8 weeks of an interactive multimedia     educational program compared to waiting list control group on improving health and weight     status in Chinese-American children, ages 8 and 10, over a 6 months period. A total of 60     Chinese-American children and their families will be randomized to either the intervention     group or waiting list control group. The intervention is based on Social Cognitive Theory and     principles of Chinese culture and practices. The intervention program includes a one-hour     small-group session for eight weeks for children and two 2-hour small-group sessions for     parents. Baseline data will be collected before assigning the children to the intervention or     control group. Follow-up data will be collected immediately after the intervention and 3     months and 6-months post intervention. A repeated measures (longitudinal) design employing a     linear mixed models approach will be used for analysis.   "
204534|NCT00530608|"     The pulmonary veins are the predominant sources of AF induction and maintenance. This study     aims to assess the electrophysiological properties of the pulmonary veins and their relation     to AF in humans.   "
204234|NCT00522990|"     The goal of this clinical research study is to find the highest tolerable dose of AT9283 that     can be given to patients who have ALL, AML, CML, high-risk myelodysplastic syndromes, or     myelofibrosis with myeloid metaplasia. Researchers want to perform pharmacokinetic (PK)     testing on blood to find out how quickly the study drug leaves the body and how the body     breaks down the drug. The safety and effectiveness of this drug will also be studied.   "
204235|NCT00523003|"     Study hypothesis: High protein diets have been shown to make people full and and help to     retent of muscle mass. This study was designed to determine effects of a protein- enriched     meal replacement (MR) on weight loss and muscle mass retention by comparison to an equal     calorie carbohydrate-enriched MR.      Methods: Single blind, placebo-controlled, randomized outpatient weight loss trial in 100     obese men and women comparing two equal calorie meal plans.,1) 2.2 g protein/kg of LBM per     day [high protein diet (HP)] or 2) 1.1 g protein/kg LBM/day standard protein diet (SP). Body     weight, body composition, and lipid profiles were measured at baseline and 12 weeks.   "
204236|NCT00523016|"     Acupuncture has been used with good results for many years at Toronto Rehabilitation     Institute Lyndhurst Centre (Toronto, ON, Canada), Parkwood Hospital (London, ON, Canada) and     GF Strong Rehabilitation Institute (Vancouver, BC, Canada) to reduce burning pain in     individuals with spinal cord injuries (SCI). This multi-centre RCT will test an acupuncture     protocol for treatment of burning pain in 40 people with burning pain in SCI, using a sham     acupuncture protocol as the control.      Objectives of Study:        1. To determine the feasibility of conducting a real acupuncture vs. sham acupuncture trial          in a multi-centre study using the Lyndhurst Central Neuropathic Pain Acupuncture          Protocol (LCCNPAP). This will inform a larger study which will directly evaluate the          effect of the LCCNPAP on pain and Quality of Life (QOL) in individuals with SCI.        2. To determine which outcome measures are most responsive and the amount of change that          could be expected, with respect to pain and QOL, for the larger study.        3. To obtain preliminary data to determine subject numbers for future studies evaluating          the effect of the acupuncture protocol.   "
204237|NCT00523029|"     This study seeks to adapt an existing chronic disease self-management program for people with     both chronic medical illness and depression.   "
204238|NCT00523042|"     This trial is conducted in Europe, Asia, Oceania and the United States of America (USA).      This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin     to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.   "
204239|NCT00523055|"     Pain Clinic patients undergoing physiotherapy for rehabilitation often have arm freezing     performed. The quality of physiotherapy is felt to be superior with good pain control. The     quality of the freezing is felt to be better when it is done with ultrasound guidance. We are     able to use less drug to achieve the same result. For this reason, we are doing a study to     look at the level of freezing drug that accumulates in the body. We feel that the drug levels     will be significantly different. We also feel that the time-to-peak drug level will be     different than with traditional arm freezing procedures.   "
204240|NCT00523068|"     In patients with symptoms of mixed incontinence (loss of urine associated with     coughing/sneezing/laughing, and loss of urine associated with the strong urge to void), is     surgical treatment with tension free vaginal tape or pharmacological treatment with     tolterodine more effective? What are the parameters predictive of success or failure with     either forms of treatment? What are the parameters predictive of the necessity for further     treatment after primary treatment?      Patients will be randomised to having surgical or pharmacological treatment for their mixed     incontinence symptoms. They will be assessed subjectively and objectively pre-treatment and     after treatment at intervals up to 3 months.   "
204241|NCT00523081|"     STAND is a research study testing a way to help teens between 12-18 years of age who have     symptoms of sadness or depression. The study hopes to learn if teens do better if they get     five to nine counseling sessions of cognitive behavioral therapy coordinated with the support     of their doctor. All teens who join the study will keep seeing their doctor as usual.      Teens and a parent are interviewed briefly over the phone to see if they are appropriate for     the study. If they qualify for the study, there is an hour-long interview with teen over the     telephone and a 30 minute interview with the parent. The interview will include questions     about the teen's mood, feelings, behavior, and how they get along with friends and family     members. The parent is also asked about his or her own feelings and mood. If the teen and     parent join the study, they will be interviewed six more times in the next two years.      Half the teens in the study will also meet with a research counselor for five to nine     individual, weekly sessions that last about 50 minutes each. Whether a teen attends the     weekly counseling sessions is decided by chance, like flipping a coin. If teens are assigned     to these sessions, they will learn ways to deal with stress and feel better. If teens take     part in the counseling sessions, the study counselor will also talk to the teen's doctor from     time to time to help plan for the best possible care.   "
204242|NCT00523094|"     The primary objective of this study is to estimate the accuracy of the pre-operative VRI     quantitative results versus the gold standard pre-operative perfusion scan.      The secondary objective is to assess the correlation of the predicted post-operative lung     function with the observed post-operative lung function (forced expiratory volume in 1 second     [FEV1] and diffusing capacity of the lung for carbon monoxide [DLCO]) in patients who     underwent surgical resection.   "
204243|NCT00523107|"     The objective of this study is to conduct a trial in the spirit of providing as much as     possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and     safety of PG2 for relieving fatigue among advanced cancer patients who are under standard     palliative care (SPC) at hospice setting and have no further curative options available.     Patient's fatigue status, to be measured by the Brief Fatigue Inventory-Taiwanese Form     (BFI-T), will be the primary endpoint. The fatigue improvement response rate among patients     between two study arms will then be compared as the basis for efficacy evaluation at the end     of the first treatment cycle, and will be the primary endpoint. Other endpoints, the fatigue     improvement response rate and the mean fatigue scores change from baseline among patients     within and between cycles will be included in the secondary efficacy endpoints, and will be     compared between two study arms. Patients' quality of sleep, appetite, pain, fatigue, nausea,     vomiting and global quality of life (QoL) will be also measured by 11 questions (SS11) from     EORTC QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints include     Karnofsky performance scores, and weight change and its related c-reactive protein level of     the patients.      * BFI-T (Brief Fatigue Inventory - Taiwan) : The BFI is a 9-item self-administered     questionnaire which was developed by MD Anderson Cancer Center offers assessing levels of     fatigue. Subjects rate each item based on how they felt for the preceding week using a 1-10     numeric rating scale (10 being the most unfavorable response). The single construct of the     BFI allows for the mean of the nine items to be the overall score. The score is categorized     as mild (1-3), moderate (4-6), and severe (7-10). The scale is a reliable instrument that     correlates highly with similar fatigue and performance status measures.   "
204245|NCT00523133|"     The purpose of this study was to compare the effects of two psychosocial treatments that     differed in scope and intensity (Broad Spectrum Treatment and Motivational Enhancement     Treatment) combined with 3 or 6 months of treatment with naltrexone on alcohol drinking     behaviors in alcohol dependent patients.   "
204246|NCT00523146|"     The objectives of this clinical trial are:        -  To further study the safety of Kanion Capsule (GF) in primary dysmenorrhea subjects;        -  To further evaluate the efficacy of GF in treatment of primary dysmenorrhea.   "
204247|NCT00523159|"     This study was conducted in order to evaluate the efficacy and safety of the cancer vaccine     IMA901 and GM-CSF as adjuvant in the treatment of advanced renal cell carcinoma.      Patients received vaccination with GM-CSF followed by IMA901 during the study period of 9     months. Patients received pre-treatment with a single i.v. infusion of cyclophosphamide prior     to the first vaccination.   "
204248|NCT00523172|"     Purpose of this study is to examine the effect of chiropractic adjusting (manipulative     therapy) and rehabilitation on hip osteoarthritis (hip OA) in older adults.   "
204249|NCT00523185|"     The purpose of this study is to compare the efficacy of two commonly used medications in the     treatment of alcohol withdrawal, diazepam and lorazepam.   "
204250|NCT00523198|"     The purpose of the study is:        -  to correlate salivary cortisol to free serum cortisol (as salivary cortisol is          considered to be almost complete free cortisol) and,        -  to correlate free serum cortisol to total serum cortisol levels      Both in patients with septic shock (severe sepsis requiring vasopressors).      We believe that:        -  total serum cortisol does not correlate with free serum cortisol in patient with septic          shock and,        -  that salivary cortisol correlates with free serum cortisol and can be used to determine          the level of free serum cortisol.   "
204251|NCT00523211|"     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells     that fight infection). Previous smaller studies in HIV treatment-experienced patients, have     shown that vicriviroc is safe and effective. The purpose of this study is to confirm the     previous findings in a larger phase 3 study over a 48-week period, and show that when taken     in combination with other appropriate HIV drugs, vicriviroc can decrease the level of HIV     (viral load) in the blood and that it is well tolerated.   "
204252|NCT00523224|"     Study title: A Study of Combined Coronary Artery Bypass Grafting (CABG) and Blood-Borne     Autologous Angiogenic Cell Precursors Therapy in Patients with Congestive Heart Failure due     to Ischemic Heart Disease (ACPs-CHF) Principle Investigator: Kit V. Arom ,M.D.,Ph.D. Deputy     Director, Chief Cardio-Thoracic Surgeon, Bangkok Heart Hospital Study objective : To     determine the safety and efficacy of injection of blood-borne autologous ACPs into the     non-graftable area of the heart of patients with congestive heart failure due to ischemic     heart disease Its main goal is evaluation of feasibility and safety of the combined     technique. The efficacy of the treatment will be tested in the following trial.      Study Design : Phase I , a single center, a non-randomized, open-label trial to test the     safety, of intramyocardium transepicardium administration of ex vivo expanded autologous ACPs     administered in combination with CABG operation in patients with congestive heart failure due     to ischemic heart disease.      The study is a preliminary training study, under the supervision of the experienced Dr. Patel     the U.S. principal investigator.      Study population :      Total expected no. of patients : 5 main selection criteria :        1. Patients with or without signs of congestive heart failure due to ischemic heart disease          who had maximal medical treatments. Not suitable to percutaneous intervention        2. All patients must have a recent coronary angiogram. Patients must be able to have OPCAB          and then have Angiogenic Cell Precursors(ACPs) in non-graftable and/or infraction          regions        3. Age 18 to 80 years        4. MRI demonstrating areas of viable and non-viable myocardium Investigational Product :          The patients will be blood drawn 250 ml at D-8 for producting autologous ACPs          (VescellTM), On D0 ,at least 1.5 million ACPs with viability >75 % supended in 15 ml          sterile cell culture medium will be injected 1 cm apart using a 23 gauge angled needle          in 30 spots (0.5 ml /point) to the same patients by direct intramuscular approach at LV          during CABG.      The study consists of 4 periods: Screening ( D-14 to-9& D-8,Treatment(D0),Acute Safety     follow-up (D1-2& D5-discharge),Chronic follow-up (D30 & D90)period ,total follow-up of each     case is 3 months.      Evaluation criteria :      Safety : no.& duration of adverse event & serious adverse event Efficacy :NYHA, 6-minute     walking test ,% LVEF by Echocardiography & C-MRI, % infracted scar area on C-MRI , Pro-BNP &     3 months of QoL(SF-36)   "
204253|NCT00523237|"     The purpose of this study is to:        -  Provide raltegravir to subjects with HIV and an undetectable viral load who are          experiencing injection site reactions (ISR) to Enfuvirtide,        -  Monitor the safety and efficacy of raltegravir, and        -  Assess the change in quality of life in patients who have switched from Enfuvirtide to          raltegravir   "
204254|NCT00523250|"     A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and     ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The     Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic     Solution will not be different from that of its vehicle.   "
204255|NCT00523263|"     Clinical trial for the comparison of long-term patency of heparin-bonded Dacron and human     umbilical vein vascular prostheses in above-knee femoro-popliteal bypass surgery.   "
204256|NCT00523276|"     The purpose of this study is to understand how severe acute respiratory syndrome (SARS)     spreads within families, if significant disease resulted, and how the body responds to SARS.     The study will also explore the affects of SARS on genetics and the immune system (the body     system that fights disease). Up to 1000 people residing in Beijing, China may be involved in     this study. Adult survivors of SARS (numbering 200) and their family members including     children age 4 and up will be asked to participate in the study. The study will recruit an     additional 200 persons, who will be matched with SARs survivors of similar age, gender,     health status, and housing/work location, and recruited as comparators. Blood will be taken     from all volunteers and tested for the presence of SARS antibodies (proteins made by the     body's immune system in response to something that can cause infection). Health and     clinic/hospital visit records may be reviewed.   "
204257|NCT00523289|"     The purpose of this study is to determine if bupivacaine (75% levobupivacaine plus 25%     racemic bupivacaine) with vasoconstrictor is effective and safety as ropivacaine in brachial     plexus block for orthopedic surgery.   "
204274|NCT00523510|"     This study will investigate the feasibility of HIV positive mothers in Tanzania to correctly     use the Flash-heat method to pasteurize their breast milk and for how long they are able to     do so. The patients will be followed in this study for up to 3 months of Flash-heating their     milk. Flash-heated breast milk could be a potential method to reduce mother-to-child     transmission of HIV. The investigators will also collect infant health data to pilot a future     efficacy trial. The investigators hypothesize that with enhanced home-based infant feeding     counseling, mothers will be capable of Flash-heating their breast milk.   "
204258|NCT00523302|"     In this pilot study, the PI proposes to include 20 African American participants with     Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms. The focus on     African Americans is due to the mandate from the funding source (internal), as well as     possible higher prevalence of FM in AA women. If recruitment is slow, the PI proposes to open     up the study to other groups. Twenty subjects will be randomized to either sham or active TMS     condition. Inclusion/exclusion criteria are well thought out and seem appropriate.     mTreatments will be administered at IOP 5 times/wk with each session lasting 20 minutes. Pain     intensity and unpleasantness will be measured pre and post each TMS session using three     different pain evaluation paradigms. GCRC resource is mainly requested for two blood draws     pre and post first TMS session. The blood samples will be used to measure inflammatory     cytokines IL-1, IL-6, AND IL-8. The main aim is to ascertain feasibility of the study and     secondary aim is to gather information on variability in response for power analysis for     future larger study. The introduction and rationale (including pain evaluation, and methods     relating to TMS) are clearly presented. Use of GCRC resources seem appropriate.   "
204259|NCT00523315|"     To describe patients' compliance of taking Aromatase Inhibitor as an adjuvant treatment in     the postmenopausal, early breast cancer as seen under current practice   "
204260|NCT00523328|"     This study is to observe the long-term treatment of BG9924   "
204261|NCT00523341|"     The primary objective was to describe the safety and tolerability of up to 10 years or 7     years denosumab administration as measured by adverse event monitoring, immunogenicity and     safety laboratory parameters in participants who previously received denosumab or placebo,     respectively.   "
204262|NCT00523354|"     Eosinophilic Esophagitis (EE) is a chronic inflammatory disorder of the esophagus with a     constantly increasing prevalence. It has been demonstrated that the expression of the     cytokine TNF-α is up regulated in EE and that this pro-inflammatory cytokine is highly     expressed by the keratinocytes of the esophageal epithelium in patients with active EE.     Furthermore, it has been shown that TNF-α is capable to induce eotaxin-3 production in     keratinocytes. These results suggest that TNF-α plays a crucial role in the pathogenesis of     EE. Based on these findings, the investigators plan a prospective T1 translational study with     the purpose to evaluate the efficacy of an Infliximab monotherapy in adult patients with     severe, corticosteroid-dependent EE.   "
204263|NCT00523367|"     The purpose of this study is to determine which COPD patients have GERD and if COPD patients     with GERD treated with high dose lansoprazole for 1 year decreases the frequency of COPD     exacerbations compared to the previous year without treatment.   "
204264|NCT00523380|"     This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of     rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease     after, first line therapy. Patients will be treated for 6 months.   "
204265|NCT00523393|"     In this trial, it will be studied whether early addition of the long acting insulin analogue     Glargine is capable of increasing the number and differentiation of endothelial progenitor     cells (EPC) in patients with type 2 diabetes, which can be seen as a marker of vascular     regenerative potential and cardiovascular risk. In addition, the effect of Glargine on     microvascular function will be studied. This will be done using laser Doppler measurements of     the skin; in addition, MRI of the heart will be performed which is capable of quantifying the     perfusion reserve of the myocardium and additional functional aspects of ventricular     function. A beneficial effect of early addition of bedtime Glargine on EPC and vascular as     well as myocardial function in this study might argue for a change in the therapeutic     approach in type 2 diabetes and possibly improve the cardiovascular outcome in patients     affected.   "
204266|NCT00523406|"     To assess the CNV treatment effect of PDT with verteporfin in combination with IVTA using     reduced fluence compared to the standard fluence.   "
204267|NCT00523419|"     The primary purpose of your participation in this study is to help answer the following     research questions, and not to provide you treatment for your condition.        -  To assess how well treatment with pemetrexed works for patients with your type of cancer        -  To assess for any side effects that might be associated with pemetrexed.        -  To look at the characteristics and levels of certain of your genes and proteins to learn          more about osteosarcoma and how pemetrexed works in your body.   "
204268|NCT00523432|"     The aim of the trial is to determine the recommended phase II dose of weekly intravenous     topotecan in combination with a fixed dose (25 mg or 15 mg) of weekly intravenous     temsirolimus in patients with and without prior pelvic radiation.   "
204269|NCT00523445|"     The primary objective of this project is to examine the effects of varenicline treatment used     concomitantly with antipsychotic medications, on cognitive dysfunction in people with     schizophrenia. The secondary objective is to evaluate the effect of this combination therapy     on smoking in people with schizophrenia. This study will be a randomized, double blind,     parallel group, placebo controlled 8 weeks trial.   "
204270|NCT00523458|"     Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the     sites where the virus is located, this study is designed to see whether it is necessary to     use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with     rifampin, one of the drugs commonly used to treat TB. Participants will be assigned to one of     4 arms (see below) and will be followed during the time when they are receiving both     treatments.   "
204271|NCT00523471|"     To check the radiosensitivity level in individual patients based on their DNA damage level.   "
204272|NCT00523484|"     This study is an observational study to see whether anxiety level can be correlated with PSA     level under the current practice in the patients of prostate cancer taking hormonal therapy.     For assessment of anxiety level BAI(Beck Anxiety Inventory) will be used. The target     population for this study is the patients of prostate cancer diagnosed previously and who are     taking hormonal therapy with regular follow-up and PSA test. The follow-up duration will be     total 6 months with interim visit at 3 month and final visit at 6 month.   "
204273|NCT00523497|"     The purpose of this study is to determine whether the noninvasive ventilation is more     effective in the treatment of severe comunity acquired pneumonia in comparison with the     conventional mechanical ventilation with orotracheal intubation.   "
204287|NCT00523679|"     The purpose of this study is to investigate the extent of Symbicort use in patients     prescribed Symbicort as maintenance and reliever therapy.   "
204275|NCT00523523|"     The purpose of this study is to determine whether or not having people with stroke practice     performing tasks to auditory rhythm cues with their weaker arm and hand is any better at     promoting improved motor control than practicing the tasks in a typical way without the     rhythm cues   "
204276|NCT00523536|"     The purpose of this trial is to study the effect of a patient navigator-nurse team in     improving the management of hypertension and other cardiovascular disease risk factors in a     health care system taking care of a vulnerable, mostly Latino population.   "
204277|NCT00523549|"     The purpose of this study is to determine the effects of treatment with valsartan +     amlodipine to a target systolic blood pressure (SBP)<130 mmHg compared to the Joint National     Commission on the Treatment of Hypertension 7 recommended target SBP of <140 mmHg on the     intrinsic diastolic properties of the myocardium in patients with hypertension and     echocardiographic evidence of diastolic dysfunction.   "
204278|NCT00523562|"     The purpose of this study is to assess how the macronutrient composition of the diet effects        -  lipid and glucose metabolism        -  intrahepatic lipids        -  insulin sensitivity      in healthy lean subjects and in subjects with a high metabolic risk (ie overweight and     offsprings of patients with type 2 diabetes mellitus).   "
204279|NCT00523575|"     Hip fractures are highly prevalent and are expected to increase due to the ageing population.     Malnutrition is often present in these patients and is associated with prolonged     convalescence, lower mobility, lower mental function, lower quality of life and higher     complication rate. Nutritional intervention starting soon after hospital admission might     reduce complication rate and total length-of-stay by improving nutritional and functional     status. Research questions are:        1. Does nutritional intervention reduce total length-of-stay?        2. Is nutritional intervention cost-effective?        3. Can nutritional screening contribute to targeting of nutritional intervention, and          thereby reduce costs without loss of effectiveness?      Patients randomized to the intervention group will receive oral nutritional supplements     (protein and energy enriched) and regular dietetic counselling during hospitalisation and     after discharge at patients' homes for 3 months. Patients in the control group will receive     usual nurse and dietetic care. Outcome measurements will be taken at baseline, 3 months and 6     months after inclusion.   "
204280|NCT00523588|"     The purpose of using the 595 nm Vbeam Perfecta™ flashlamp-excited, pulsed dye laser in this     study is to help improve study patients' skin disease. Cutaneous lupus erythematosus (CLE)     often presents with disfiguring vascular lesions which are frequently difficult to treat with     the available therapeutic measures, such as photoprotection, topical steroids, and     antimalarials. Laser therapy provides an alternative treatment option for CLE patients.     Although there has been documented experience with laser treatment in CLE patients, no study     comparing treated lesions to the natural course of the disease has been conducted.   "
204281|NCT00523601|"     To reassure the clinical study data on Seroquel antidepressant efficacy in patients who are     diagnosed as bipolar depression   "
204282|NCT00523614|"     The objective of this study is to compare the risk of venous thromboembolism (VTE) of oral     contraceptives with non-use, focusing specifically on Valette® compared to other users of low     estrogen dose combined oral contraceptives.   "
204283|NCT00523627|"     This study, conducted at the NIH Clinical Research Unit at the Phoenix Indian Medical Center,     will examine how the body s metabolism (energy expenditure) changes when people overeat and     when they fast and how different diets (e.g., high-protein or high-fat) affect metabolism.     The results may provide information about whether there are mechanisms that make some people     more resistant than others to gaining weight when they eat more.      Non-smoking healthy subjects between 18 and 55 years of age who weigh no more than 350 pounds     may be eligible for this study. Participants undergo the following procedures:        -  Pregnancy test for women of childbearing age.        -  Oral glucose tolerance test. For this test, an I.V. line (needle attached to a plastic          tube) is inserted into a vein to allow several blood draws without repeated needle          sticks. After the first blood sample is drawn, the subject drinks a cola-flavored sugar          solution. Five additional blood samples are then drawn over 3 hours.        -  Blood test for DNA (genetic) studies related to obesity, diabetes and related medical          problems.        -  DEXA scan. This test measures body fat. The subject lies on a table while a very small          dose of X-rays is passed through the body.        -  Respiratory chamber. This test measures how many calories the body burns a day and          assesses energy balance between intake and expenditure. Subjects stay in a room with two          windows, equipped with a sink, toilet, television and DVD player, desk, chair, telephone          and bed for 24 hours. The test is repeated five times during the first 18-day admission          and 3 times during the second 13-day admission. For the first two sessions, subjects are          fed a diet equal to the amount of energy their body uses. For the next 6 stays they are          fed double the amount of calories their body usually uses for 5 of the stays and fast          (consume nothing but water and soda without caffeine or calories) during 1 stay. The          overfeeding diets may be high or low in protein, normal in protein, or high in fat.          Blood tests are done on the day of each respiratory chamber session and a 24-hour urine          sample is collected for one day while in the chamber.        -  Eating behavior questionnaires.        -  Psychological performance tests.      Some participants are asked to volunteer to repeat two of the chamber studies to validate the     measurements. The repeat session includes only the fasting and the overfeeding with normal     protein content.      All participants are followed at 6 months with blood tests, a DEXA scan, and urine tests     (including pregnancy test for women). At annual visits for years 1 through 7, participants     have the 6-month tests plus an oral glucose tolerance test.   "
204284|NCT00523640|"     The purpose of this study is to find out what effects (good and bad) the combination of the     chemotherapy drugs gemcitabine, capecitabine, and bevacizumab has on a patient and kidney     cancer.   "
204285|NCT00523653|"     Dilated cardiomyopathy (DCM) affects about 200,000 Canadians. Eighty percent of these cases     are of unclear cause, often occuring in families. We believe that mutations in specific     already-identified genes contribute to DCM in Quebec and that certain mutations may account     for a significant proportion of cases due to the well-documented founder effect. Two     hundred patients with DCM followed in our Heart Function Clinic will be approached for one     blood sample at their routine clinic visit to test this hypothesis. The samples will be     tested in the Laboratory of Cardiovascular Genetics at the Royal Victoria Hospital.   "
204286|NCT00523666|"     Alzheimer's disease (AD) is characterized by progressive subcortical and cortical neuronal     degeneration. AD patients differ in the time course of neuronal degeneration and accompanying     cognitive decline.      With recent advances in MR imaging, including optimized data acquisition and processing     techniques, tools that are especially well suited for tracking long-term pathological changes     as well as drug treatment effects have become available. In addition to structural imaging,     new acquisition and analysis techniques have been developed to determine integrity of     subcortical fiber tracts in vivo.      In the present project we propose to determine predictors of disease progression and     treatment response and investigate potential treatment effects on structural disease     progression, covering the continuum from axonal degeneration to cortical neuronal loss taking     advantage of recent advances in MRI acquisition and analysis techniques.   "
204288|NCT00523692|"     Rheumatoid arthritis (RA) is a debilitating chronic immune mediated inflammatory disease     which affects 1% of the European population. RA is associated with significant joint damage,     disability and an enhanced mortality. Current treatment strategies target patients once     synovitis has been present for several months and it is clear that the patient has developed     persistent disease. After the first 3 months of symptoms, we and others have shown that the     persistence of chronic inflammation in the rheumatoid synovium is driven by hyperplastic     stromal tissue which inhibits leukocyte apoptosis leading to the accumulation of inflammatory     cells in the joint. Therapies at this stage of disease, with conventional disease modifying     anti-rheumatic drugs (DMARDs) as well as drugs targeting TNF-alpha reduce disease activity     but are unable to cure RA. We have now identified that the very early phase of synovitis in     patients destined to develop RA (within the first 12 weeks of symptoms) represents a     pathologically distinct phase of disease. This suggests that late disease is not just more of     early disease and gives, for the first time, a clear rationale for very early intervention.     Building on these recent observations, we propose to test the hypothesis that the disease     processes in the very early stages of RA are fundamentally different to those in established     chronic disease. This will be done by assessing whether treatment during this phase with the     well-established gold standard modality of anti-TNF-alpha therapy and methotrexate can     permanently switch off inflammation, preventing the development of RA and thereby effecting a     cure of the disease.   "
204289|NCT00523705|"     The purpose of this pilot study is to determine the efficacy and safety of escitalopram     administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in     young women ages 15-19 years.   "
204290|NCT00523718|"     Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal     of suffering. Many patients benefit from established treatments, the mainstay of which are     cognitive behavioral therapy and a group of antidepressant medications known as serotonin     reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established     therapeutic strategies. New avenues of treatment are urgently needed.      Existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin     or dopamine; but increasing evidence suggests that functional disruptions of a different     neurotransmitter, glutamate, may contribute to some cases of OCD. The investigators are     therefore interested in using medications that target glutamate as novel treatment options     for those OCD patients who do not benefit from established treatments.      One such medication is the drug riluzole, which is FDA approved for amyotrophic lateral     sclerosis (ALS), or Lou Gehrig's disease, but may be of benefit to patients with psychiatric     disorders due to its ability to moderate excessive glutamate. In preliminary studies, in     which the investigators treated patients with riluzole (in addition to their established     pharmacological regimen) in an open-label fashion (that is, without a placebo-treated control     group), the investigators have found about 40-50% of patients to substantially improve over     2-3 months.      While immensely promising, these preliminary studies do not prove riluzole is truly a new     beneficial medication for the treatment of OCD; a more rigorous placebo-controlled trial is     needed for that purpose. The investigators are therefore now recruiting patients to     participate in a double-blind, placebo-controlled trial of riluzole, added to whatever other     OCD medications they are taking.   "
204291|NCT00523731|"     Study title: A Study of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients     with Critical Limb Ischemia ( ACPs-CLI )      Principle Investigator: Assoc.Prof. Pramook Mutirangura,M.D. Head of Division of Vascular     Surgery , Department of Surgery, Faculty of Medicine Siriraj Hospital , Mahidol University,     BKK,Thailand      Study objective : To determine the safety and efficacy of intramuscular injection of     blood-borne autologous ACPs in relieving symptoms of critical limb ischemia of patients     treated with maximal medical therapy and don't have intravascular or operative     revascularization option.      Study Design : A pilot study , a single center, a non-randomized, open-label trial.      Total expected no. of patients : 6 main selection criteria : A. Subjects will have one or     more clinical indications diagnostic of CLI such as: distal extremity pain at rest that     requires the subject to use analgesics for >2 weeks; or peripheral ischemic ulcer(s); or     areas of gangrene ; or non-healing ischemic ulcers AND      B. Subjects will have one or more of the following hemodynamic indicators of severe     peripheral arterial occlusive disease:      I. Ankle brachial index < 0.45 II. Toe brachial index < 0.35 III. TcPO2 / TcO2 of < 40 mmHg.     C. The subject is a poor candidate for standard revascularization treatment for peripheral     arterial disease, based on inadequate bypass conduit, or unfavorable anatomy D. Age 18 to 80     years      Investigational Product : At D-8 250 ml of blood drawn from the patients for production of     autologous EPCs or ACPs (VescellTM). On D0 ,at least 1.5 million ACPs with viability >75 %     suspended in 30 ml sterile cell culture medium will be injected 1.5 cm deep and 1.5 apart by     a 23 -gauge needle into the gastrocnemius muscle of the leg chosen (ischemic leg) for     treatment. For injection planning a grid of 10X10 cm will be prepared and in each point 1 ml     of ACPs suspension will be injected.      The study consists of 4 periods: Screening ( D-14 to-9& D-8,Treatment(D0),Acute Safety     follow-up (D1&D2),Chronic follow-up (D30 & D90)period ,total follow-up of each case is 3     months.      Evaluation criteria :      Safety : no.& duration of adverse event & serious adverse event Efficacy :Attenuate CLI     patients symptoms (Rest pain,Pain-free walking distance,Ulcer size &Gangrene dimension and     intensity)   "
204292|NCT00523744|"     This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose     combination in adults with moderate, inadequately controlled hypertension. There was an     optional study extension for eligible patients who wanted to participate that contains the     triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).   "
204293|NCT00523757|"     Heart failure causes significant morbidity and mortality and is the most rapidly increasing     cardiovascular diagnosis in North America overall prevalence is estimated at 0.4% to 2.4%.     Recently, heart failure with a preserved ejection fraction (HFNEF) was found in up to 50% of     patients with symptomatic heart failure. Many studies have demonstrated that HFNEF has a poor     prognosis with a mortality rate of up to 8% per year and a 50% chance of needing to be     admitted to hospital in the next year. There are no proven therapies for this type of heart     failure.      Aldosterone blockers (these drugs block a hormone that is elevated in patients with heart     failure) are used in other types of heart failure. Our goal is to see if this type of drug     improves the function of the heart by looking at the thickness of the heart muscle using MRI.     Also we will measure the amount of tissue formation and breakdown in the heart. The trial     will be done using both the drug and a placebo so that we can see what effects are due to the     drug.   "
204333|NCT00524290|"     The objectives of this multinational study are to assess the clinical outcomes of patients     with Acinetobacter bloodstream infection and to further assess the predictors of mortality in     this patient population. We also aim to characterize the molecular epidemiology of this     remarkable organism in an attempt to further understand its transmission dynamics on a global     level and to determine whether increased pathogenicity is geographically dependent.   "
204294|NCT00523770|"     GSK Biologicals is working on the development of a vaccine to protect elderly people from     pneumococcal infection. For the future studies in that project, it would be useful to have     some easy non invasive tests to detect infection by the bacteria. Some tests on urine are     already on the market but need to be improved in the laboratory. For that purpose, some urine     samples from healthy subjects aged 65 years or above and who have not suffered from pneumonia     nor have been administered pneumococcal vaccination in the past 3 months are needed.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007   "
204295|NCT00523783|"     To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or     schizoaffective disorder   "
204296|NCT00523796|"     This is a multi-centre survey of patients who are currently on lipid-lowering pharmacological     treatment. Data collection for each patient will take place at one visit.   "
204297|NCT00523809|"     The goal of this clinical research study is to learn if giving Avastin (bevacizumab) with     standard chemotherapy and a blood stem cell transplant, in patients with an advanced solid     tumor, can help to shrink the tumor or slow its growth. The safety of this treatment will     also be studied.   "
204298|NCT00523822|"     This study seeks to determine if the correction of a sacroiliac lesion can produce a     functional change in cervical spine. Reduction of a sacroiliac joint lesion may alter     cervical spine function.   "
204299|NCT00523835|"     Klinefelter syndrome (KS) is the most common sex-chromosome disorder with a prevalence of one     in 660 men and is a frequent cause of hypogonadism and infertility. It is caused by the     presence of extra X-chromosomes, the most common karyotype being 47,XXY. The phenotype is     variable, but the most constant finding is small hyalinized testes, hypergonadotrophic     hypogonadism, infertility, eunuchoid body proportion, increased height and learning     disabilities. Klinefelter syndrome has been associated with increased prevalence of diabetes,     osteoporosis and cardiovascular diseases but the pathogenesis is unknown. Accordingly the aim     of the study was to investigate measures of body composition, insulin sensitivity, bone     mineral density, echocardiography, as well as biochemical markers of endocrine, metabolic and     bone function in KS and an age-matched control group.   "
204300|NCT00523848|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride     liposome, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma     by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin     hydrochloride liposome and thalidomide may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin     hydrochloride liposome and thalidomide works as first-line therapy in treating patients with     previously untreated multiple myeloma.   "
204301|NCT00523861|"     Moderate alcohol consumption is associated with a decreased risk of type II diabetes     mellitus. In a recent study of Greenfield et al. it was observed that moderate alcohol     consumption significantly improved postprandial glucose concentrations. Similar observations     were made in our previous study. One of the mechanisms by which this may occur is delayed     gastric emptying after alcohol consumption.   "
204302|NCT00523874|"     Previously our retrospective study showed that almost half of the patients with acute     alcoholic pancreatitis had a recurrent attack in the long-term, mild pancreatitis and young     age being risk factors for recurrence. The aim of this prospective follow-up study was aimed     to find out the risk factors in detail.   "
204303|NCT00523887|"     The purpose of this study is to assess the clinical utility and safety of Fentanyl for pain     treatment caused by radiotherapy. Fentanyl is a synthetic pure opioid agonist with a     selective activity on µ receptors.   "
204304|NCT00523900|"     Intervention study in malnourished adults to assess whether a nutritional supplement given     for 8 weeks in addition to the subject's usual diet improves body weight, body composition,     biochemical and immune parameters.   "
204305|NCT00523913|"     This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks   "
204306|NCT00523926|"     The purpose of this study is to assess the effects of 3 different oral doses of TMC207     administered over a 7 day period on the organism that causes tuberculosis   "
204307|NCT00523939|"     The purpose of this study is to determine the response rate of lymphomatous meningitis or     leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well     to the study drug, and the response of symptoms to the study drug will also be determined.   "
204308|NCT00523952|"     Objective: Assess efficacy and safety of tacrolimus ointment when used in adults with     moderate or severe atopic dermatitis. The ointment was applied on the affected skin twice     daily for 3 weeks and then once daily until all lesions were cleared   "
204309|NCT00523965|"     Rationale      The overall objective of this trial is to identify a safe and effective combination,     (co-administration) short course treatment for the treatment of VL which could be easily     deployed in a control programme. The hypothesis is that the combination treatment is as     effective or better than the 5 mg/kg single dose of AmBisome and will reduce the risk of     parasite resistance occurring. Safety and tolerability should be such that the combination     can be easily deployed.      Objective      The specific primary and secondary objectives are as follows:      Primary objective:      To identify a short course combination treatment regimen which is at least as effective as a     single dose of AmBisome 5mg/kg      Secondary objective:      To compare safety and tolerability of the various treatments measured by vital signs, blood     biochemistry, (renal and liver function tests) haematology, spontaneous and elicited adverse     event reporting      Primary Endpoint:      The primary efficacy endpoint variable is parasitological clearance 2 weeks after start of     treatment with no relapse during follow up and no clinical signs or symptoms of VL at 6     months post treatment.      Parasitology is only carried out at any time during follow-up or at six months post treatment     if there are signs or symptoms of VL infection.   "
204334|NCT00524303|"     This study will examine safety and efficacy of Lapatinib in combination with a standard     neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor     tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to     treatment.   "
208206|NCT00574262|"     The purpose of the study is to evaluate the quality of care on a 16 bed stroke unit by using     a new developed clinical pathway.   "
204310|NCT00523978|"     This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical     investigation conducted at 26 investigational sites in the United States and Canada. Subjects     with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy     failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or     sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a     Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and     symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic     electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated     trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90     days after study therapy was initiated was considered a blanked period for all subjects.   "
204311|NCT00523991|"     A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the     efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler     once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol     (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.   "
204312|NCT00524004|"     This is a Phase II, randomized, double-blind, placebo-controlled study designed to     investigate whether hyperimmune bovine milk IgG products specific for CsbD and CS17, protect     subjects against diarrhea upon challenge with a CS-17-ETEC strain LSN03-016011/A. The study     will also evaluate safety and tolerability of these bovine milk IgG products and describe the     immune responses following challenge.      The primary study objectives are: 1) Assess safety of the anti-CsbD and anti-CS17 bovine milk     IgG among healthy adult volunteers when orally administered three times a day over 7 days. 2)     Determine efficacy of the anti-CsbD bovine milk IgG preparation against ETEC diarrhea upon     challenge with CS17-ETEC, and 3)Determine efficacy of the anti-CS17 bovine milk IgG     preparation against ETEC diarrhea upon challenge with CS17-ETEC. A secondary objective is to     determine efficacy of the anti-CsbD and anti-CS17 bovine milk IgG preparations against     moderate to severe ETEC diarrhea upon challenge with CS17-ETEC.   "
204313|NCT00524017|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block abnormal cell growth in     different ways. Some block the ability of abnormal cells to grow and spread. Others find     abnormal cells and help kill them or carry cell-killing substances to them.      PURPOSE: This randomized phase II trial is studying how well cetuximab works in treating     patients with precancerous lesions of the upper aerodigestive tract.   "
204314|NCT00524030|"     This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by     itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment     of partial seizures. The duration of the trial is about 6 months.   "
204315|NCT00524043|"     The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of     paliperidone Extended Release (ER) as compared with placebo when used to treat patients with     schizophrenia.   "
204316|NCT00524056|"     The purpose of this study is to evaluate the effectiveness, safety and tolerability of     carisbamate treatment for the signs, symptoms, and impairment associated with Essential     Tremor (ET) compared to placebo treatment. The secondary objective is to evaluate the effect     of carisbamate treatment on indicators of affect and mood in patients who have ET compared to     placebo treatment.   "
204317|NCT00524069|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of tumor cells by blocking blood flow to the tumor. Giving gemcitabine and     capecitabine together with bevacizumab may kill more tumor cells.      PURPOSE: This clinical trial is studying the side effects and how well giving gemcitabine and     capecitabine together with bevacizumab works in treating patients with pancreatic cancer that     can be removed by surgery.   "
204318|NCT00524095|"     Bronchiectasis is a chronic pulmonary disease characterized by an irreversible dilatation of     the bronchi. The current view of the pathogenesis of bronchiectasis considers initial     colonization of the lower respiratory tract by different microorganisms as the first step     leading to an inflammatory response characterized by neutrophil migration within the airways     and secondary secretion of a variety of tissue-damaging oxidants and enzymes such as     neutrophil elastase and myeloperoxidase. Persistence of microorganisms in the airways because     of impairment in mucus clearance may lead to a vicious circle of events characterized by     chronic bacterial colonization, persistent inflammatory reaction, and progressive tissue     damage. The exact prevalence of bronchiectasis in COPD patients is not known. It would be     important to assess the prevalence, the kind of bronchiectasis and the bacterial     colonisation. These are all important features that can be related to the natural history of     COPD and to the therapeutic management of patient with COPD and bronchiectasis. Recent data     indicate that macrolide long-term treatment and inhaled steroids therapy are both associated     with a reduced rate of exacerbation, bronchial colonization and inflammation The present     study will address, on a relatively large number of patients, the prevalence of     bronchiectasis in COPD subjects using a multislice CT scan technique applied in all the units     and centrally analysed by Unit 2 and 4. This analysis will determine the presence and the     morphology of bronchiectasis. Bacterial colonization and inflammatory parameters will be     evaluated on blood and exhalate bronchial condensate. Concerning bacterial colonization     molecular biology techniques (Qualitative PCR and quantitative real time PCR) will be     applied. ELISPOT technique for the evaluation of specific immune response will be     used.Electron and optical microscopy techniques will be applied on bronchial biopsy samples     obtained in a subgroup of patients enrolled. During the second study year, a randomized trial     on patients with bronchiectasis will be performed. Patients will be randomized to receive a     macrolide or inhaled steroids or standard of care for 6 months with a follow-up of 6 months.     All the inflammatory, microbiologic and functional parameters described above will be     recorded. A clinical and functional evaluation will be applied looking to number of     exacerbations, quality of life, respiratory function parameters.   "
204319|NCT00524108|"     The objectives of this study are:        -  To describe the incidence of clinical features in adults with internal          ventriculoperitoneal (VP) shunt infections,        -  To determine the validity of laboratory parameters in adults with internal          ventriculoperitoneal shunt infections and        -  To evaluate the relationship between the timing of shunt re-implantation with the rates          of relapse and secondary infection.   "
204320|NCT00524121|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     erlotinib together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving erlotinib together with radiation     therapy works in treating older patients with stage I, stage II, stage III, or stage IV     esophageal cancer.   "
204535|NCT00530621|"     The purpose of this study is to determine if the combination of enzastaurin and pemetrexed     can extend survival time without progression of disease for patients who have advanced or     metastatic non-small cell lung cancer.   "
204321|NCT00524134|"     In up to 1 out of 3 patients with epilepsy, seizures continue to occur despite the use of one     or more antiepileptic medications. Patients also have significant problems with side-effects     of these medications as doses are increased.      Our body naturally generates miniature pumps located on the surfaces of many organs to get     rid of toxic substances, and antiepileptic medications can be considered by the cells of the     body to be a toxin. Research with epileptic brain regions have shown an increase in the     amount of drug pumps, therefore getting rid of antiepileptic drugs. One of these pumps is     called p-glycoprotein (P-gp for short). Medications may be unable to penetrate and stay     within the parts of the brain that need them them most. This may mean that the amount of drug     is actually lower in the parts of the brain that cause seizures, and higher in the rest of     the brain, which may be why patients may still feel side-effects when seizures are still     occurring.      Research in animals has shown that blocking the P-gp pumps can improve how bad, and how many     seizures occur as well as the length of seizures. Blockage of the pumps can be done using a     different type of medication. Some medications that are used for common problems have been     discovered to also block P-gp pumps. One of these, carvedilol, is used to treat heart failure     and high blood pressure. It has been found to be very safe in these patients, and does not     have a lot of side-effects. We plan to add this medication in addition to patient's     anti-seizure medications to see if it will improve epileptic seizures.      The reason why some patients have high amounts of P-gp pumps and others do not may be related     to their genetics. A simple blood test can be used to determine a person's potential to     produce high quantities of the pumps. This study will also attempt to show that the genetics     will affect how well the P-gp blocking will work.   "
204322|NCT00524147|"     Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant     residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in     addition to anti-TB drugs have been tried to rapidly relieve dyspnea caused by effusion and     to decrease the occurrence of RPT. However, contradictory results are reported without clear     reasons. The researchers' hypothesis is that, in addition to anti-TB medications, early     effective evacuation of inflammatory exudates with or without fibrinolytic agents may hasten     resolution of pleural effusion, reduce the occurrence of RPT and finally improve long-term     functional outcome in patients with TB pleurisy.   "
204323|NCT00524160|"     The purpose of this study is to assess the degree of pain control achieved by treatment with     fentanyl, administered via adhesive patches applied to the skin ('transdermal system) in     patients with rheumatoid arthritis or osteoarthritis of the knee or hip. Treatment will be     administered fo r4 weeks, added on to existing therapy with other medications.   "
204324|NCT00524173|"     This study will test whether the combination of two medications, tenofovir and emtricitabine,     are safer and more effective for treating chronic hepatitis B than tenofovir alone. Chronic     hepatitis B is a liver disease caused by infection with the hepatitis B virus. Several     medications, including standard and pegylated interferon and the anti-viral drugs lamivudine,     adefovir, entecavir and telbivudine, are currently used to treat the disease. Problems are     associated with all of these agents, however, including development of viral resistance with     long-term therapy of the anti-virals. Since many patients require long-term therapy to     prevent their disease from worsening, a major goal of new approaches to treatment is to     prevent the development of viral resistance. Combination treatment has been shown to be an     effective strategy in preventing this resistance.      Tenofovir is an anti-viral drug approved for use in patients with HIV infection. In small     studies in patients infected with both HIV and hepatitis B, tenofovir lowered the level of     hepatitis B virus in the blood, with no viral resistance reported when used for up to 5     years. Emtricitabine is an anti-viral drug similar to lamivudine and is effective at lowering     viral load and improving liver damage.      Patients 18 years of age and older with chronic hepatitis B may be eligible for this study.     Participants are admitted to the NIH Clinical Center for a complete medical history and     examination, including blood and urine tests, chest X-ray, electrocardiogram, abdominal     ultrasound, Fibroscan (ultrasound exam of the liver that measures the amount of scarring),     bone mineral density scan and liver biopsy. They are then randomly assigned to take     combination treatment with tenofovir plus emtricitabine or tenofovir alone for at least 48     weeks. During the treatment period, patients visit the Clinical Center for blood tests and a     physical examination every 2 weeks for the first month and then every 4 to 12 weeks. After 48     weeks, patients are readmitted to the Clinical Center for a complete evaluation that includes     all the tests done at the start of therapy, including a liver biopsy. Patients who seem to     have improved with treatment may continue therapy for up to 192 weeks, when they are again     admitted to the Clinical Center for a complete medical evaluation and liver biopsy. Patients     whose condition has not improved after 48 weeks of treatment have their treatment changed or     stopped and continue to have regular outpatient clinic visits for 24 more weeks.   "
204325|NCT00524186|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     sunitinib together with combination chemotherapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of sunitinib when     given together with irinotecan, fluorouracil, and leucovorin in treating patients with     advanced stomach cancer or gastroesophageal cancer.   "
204326|NCT00524199|"     The purpose of this research study is to examine the effect of a drug called mesna on the     removal of homocysteine from blood during dialysis. Homocysteine is an amino acid (protein     building block) found in the blood of all people, however it is considerably elevated in     dialysis patients. People with increased levels of homocysteine in their blood are at     increased risk of developing plaque buildup in their arteries and other related problems such     as heart attack and stroke. This study will determine if mesna can improve the rate of     homocysteine removal from blood during dialysis.   "
204327|NCT00524212|"     The purpose is to exam prospective if simple clinical information in combination with a     normal s-procalcitonin are sufficient for exclusion of infective endocarditis (IE).   "
204328|NCT00524225|"     The purpose of this study is to determine the efficacy and safety of rhIL-11 when given     subcutaneously in adults with type 1 von Willebrand disease undergoing elective surgery or     major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and     severity of bleeding and transfusion requirement during and after surgery. Safety will be     measured by the frequency of adverse events, including fever, headache, fatigue, myalgias,     arthralgias, fluid retention, or edema.   "
204329|NCT00524238|"     Hypothyroidism is a frequent condition in danish women, but often overlooked. Along with     fatigue one of the main symptoms is weight gain as a result to significantly decreased energy     expenditure.      This study was undertaken to elucidate changes in glucose, lipid and amino acid turnover in     these patients.   "
204330|NCT00524251|"     The purpose of this study is to determine whether the improvement in the quality of life     after an initial treatment with esomeprazole 40mg for reflux disease is the same in patients     who have already made lifestyle-adjustments as in patients who have not implemented     lifestyle-adjustments prior to the start of treatment (baseline)   "
204331|NCT00524264|"     This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the     treatment of inflammation and pain associated with cataract surgery.   "
204332|NCT00524277|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may     stimulate the immune system in different ways and stop tumor cells from growing. It is not     yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer.      PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works     compared with GM-CSF in treating patients with breast cancer.   "
204335|NCT00524316|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Chemoembolization kills tumor     cells by blocking the blood flow to the tumor and keeping chemotherapy drugs, such as     doxorubicin, near the tumor. Giving sunitinib together with chemoembolization may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving sunitinib together with     chemoembolization works in treating patients with liver cancer that cannot be removed by     surgery.   "
204336|NCT00524329|"     The purpose of this study is to compare the treatment effect in patients with upper     gastro-intestinal complaints with an elevated risk for NSAID-associated GI-damage to those     without an elevated risk for NSAID-associated damage (as determined by the treating     physician).   "
204337|NCT00524342|"     The purpose of this study is to determine the efficacy and safety of rhIL-11, when given     subcutaneously for six consecutive months, in reducing menstrual blood loss in women with     type 1 von Willebrand disease and refractory menorrhagia. Efficacy will be measured by     subjective bleeding severity scale and pictorial bleeding chart. Safety will be measured by     the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias,     fluid retention, or edema.   "
204338|NCT00524355|"     To describe the frequency, type and severity of the symptoms in patients visiting the GI or     internal physicians, with symptoms consistent with gastroesophageal reflux disease (GERD)   "
204339|NCT00524368|"     The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv)     800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in     early antiretroviral (ARV)-experienced patients when given along with selected optimized     background regimen (OBR).   "
204340|NCT00524381|"     The purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF)     antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR).      PMR is a common inflammatory disease with an unknown etiology that is characterized by     aching, tender, and stiff proximal muscle. Some evidence suggests that TNF plays a central     role in the pathophysiology of PMR.      The preferred treatment with glucocorticoids (GCs) is adequate for most patients, but a     subset of patients have a more prolonged, relapsing disease course. These patients require     treatment with GCs for 1 to 2 years. GC related adverse events are frequent during treatment.   "
204341|NCT00524394|"     Infants in the NICU are at high risk for morbidity and mortality from infections of any     onset. Diagnosis of these infections is imperfect at best. Patterns of inflammatory and     regulatory proteins (cytokines & chemokines, in addition to antigen detection on antibody     secreting cells (ASC's)may provide a more accurate and rapid approach to diagnosis of     infections in these high-risk patients.   "
204342|NCT00524407|"     The purpose of this study was to compare the effectiveness of epoetin alfa treatment on     hemoglobin (Hb) response, quality of life (QoL), health care resource utilization and patient     productivity when epoetin alfa was administered during chemotherapy to patients with mild     anemia or after waiting until patients became moderately anemic. Patients with lymphoma,     chronic lymphocytic leukemia (CLL) or Multiple Myeloma (MM) were studied.   "
204343|NCT00524420|"     While acute pain after surgery or trauma comes on suddenly and lasts for a limited amount of     time, chronic pain persists and can continue for months and even years. Repetitive     transcranial magnetic stimulation (rTMS) uses a magnetic field to deliver a current to the     brain and can affect brain activity. The purpose of this study is to determine the     effectiveness of rTMS treatment in reducing chronic widespread pain in women.   "
204344|NCT00524433|"     The randomized patients with acute heart failure will be stratified based on the presence or     absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the     first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of     the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days     after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up     period of 5 months for vital status.   "
204345|NCT00524446|"     This study tests the hypothesis that infants receiving milk-powder containing fortified     spread (lipid-based nutrient supplement) as a complementary food for one year have lower     incidence of severe stunting (poor length gain) than infants who are provided with no extra     food supplements or maize-soy flour for complementary porridge.   "
204346|NCT00524459|"     RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and docetaxel, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) and giving them     before surgery may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving liposomal doxorubicin     together with docetaxel before surgery and to see how well it works in treating women with     locally advanced breast cancer that can be removed by surgery.   "
204347|NCT00524472|"     Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will     be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood     glucose levels intra-operatively. Group B will be administered insulin at the standard of     care levels established by the participating institution. Patients will be followed at 10     days, 15 days and one year post-operatively.   "
204348|NCT00524485|"     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a     certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic     therapy using topical aminolevulinic acid may be effective against actinic keratosis.      PURPOSE: This randomized clinical trial is studying how well different photodynamic therapy     regimens using topical aminolevulinic acid work in treating patients with actinic keratosis.   "
204349|NCT00524498|"     The purpose of this study is to evaluate the safety and efficacy of a continuous hepatic     arterial infusion combination therapy with OPC-18 and 5-FU versus BST in patients with highly     advanced hepatocellular carcinoma for which resection therapy or local therapy is     inapplicable due to advanced vascular invasion.   "
204363|NCT00524693|"     There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased     cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast     (Singulair©) approved for use in infants as granule sachets, have become available. We     evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute     phase of RSV bronchiolitis.   "
204350|NCT00524511|"     Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The     usual way to close this opening is with metal surgical staples. In many other types of     surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at     the University of Massachusetts believe Dermabond may be a safe alternative to using staples     at the time of a cesarean delivery, but this has not been studied. Women who choose to     participate will be randomly assigned to have the cesarean delivery skin incision closed with     staples or Dermabond. The researchers will survey the patients to see how they felt about the     experience and the appearance of their scar. The researchers will survey physicians     performing the surgery to see how easy Dermabond was to use. The researchers will ask     physicians to evaluate the appearance of the incision after a 6-week recovery period and will     analyze complications (such as bruising, infection, or separation of the wound) in the two     groups.   "
204351|NCT00524524|"     This study is designed to evaluate the response of several biomarkers in patients treated     with ARQ 501. The results of the study may help the sponsor understand the effect of the     study drug on these biomarkers and their respective role in cancer growth control.   "
204352|NCT00524537|"     The purpose of this Registry study is to evaluate the long-term safety and effectiveness of     adalimumab in CD subjects who are treated as recommended in the product label.   "
204353|NCT00524550|"     A body of epidemiologic studies show that moderate alcohol consumption is associated with a     protective effect against type 2 diabetes. The importance of both insulin sensitivity and     insulin secretion in the pathogenesis of glucose intolerance and diabetes type 2 is widely     recognized. Clinical studies show improved insulin sensitivity after a period of alcohol     consumption compared to abstention. However, postprandial insulin secretion and beta-cell     function after a period of moderate alcohol consumption have scarcely been addressed in     published literature.      When consumed as an aperitif or with a meal, alcohol is generally expected to stimulate     appetite and food intake and thus might be a risk factor for over consumption and obesity.     However the physiological mechanisms for this observed effect are not well understood.     Furthermore, previous studies lacked a link between physiological parameters and subjective     parameters of satiety.   "
204354|NCT00524563|"     The primary objective is to assess for independent predictors of in-hospital mortality (up to     28 days) in patients with Acinetobacter bloodstream infection. Secondary Objectives include     the following: To determine the impact of inactive empiric antimicrobial therapy, defined as     receipt of empiric antimicrobial therapy with no in vitro activity against the offending     isolate for at least 24hrs, on the outcome (end points defined below) of patients with     Acinetobacter bloodstream infection. To determine the impact of carbapenem resistance and     pan-drug resistance (defined as resistance to all antimicrobials except colistin and/or     tigecycline if these agents were tested) on the outcome of patients with Acinetobacter     bloodstream infection. To assess the efficacy of varying definitive therapies on the outcome     of patients with Acinetobacter bloodstream infection. To characterize the molecular     epidemiology of Acinetobacter on a global level, as determined by pulsed-field gel     electrophoresis (PFGE) and other techniques, and to assess whether patient outcomes are     clonally related and to characterize the mechanisms of resistance in Acinetobacter on a     global scale.   "
204355|NCT00524576|"     To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when     given to subjects who had received primary vaccination of Engerix™-B vaccine approximately     72-78 months ago.      This protocol posting deals with objectives & outcome measures of the challenge phase. The     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
204356|NCT00524589|"     RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to     grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor     cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an     effective treatment for prostate cancer that did not respond to hormone therapy .      PURPOSE: This phase II trial is studying how well giving calcitriol together with     dexamethasone works in treating patients with prostate cancer that did not respond to hormone     therapy.   "
204357|NCT00524602|"     Patients with several heart arrythmia can potentially be cured by catheterablation. For some     arrythmias 95% of the patients are cured. Also patients with atrial fibrillation are cured by     catherablation even though the effect is not as impressive as for other cardiac arrythmias.     About 70% of patients with paroxystic and persistant atrial fibrillation are cured. Most of     the remaining obtain a reduction of their symptoms.      At conventional ablation of atrial fibrillation the catheters are manually navigated to the     ideal anatomic position where to isolate the pulmonary veins from the left atrium.      Lately it has been possible to navigate the ablationcatheters using 'remote magnetic     navigation' using a magnetic based navigation equipment, Stereotaxis.      The Heartcentre of Rigshospitalet had this Stereotaxis equipment installed in the autumn of     2006.      We will investigate the utility and safety of using this remote magnetic     navigation/Stereotaxis.   "
204358|NCT00524615|"     The purpose of this study is to evaluate the efficacy of spironolactone on lowering blood     pressure when added to therapy in patients with resistant arterial hypertension.   "
204359|NCT00524641|"     To investigate the change in patient's asthma symptom control using ACQ scores after 4 to 6     weeks of Symbicort Turbuhaler (budesonide/ formoterol) in SMART approach.   "
204360|NCT00524654|"     The purpose of this study is to test the effect of high velocity low amplitude (HVLA)     chiropractic cervical manipulation on the patient's postural control as measured by a force     plate.   "
204361|NCT00524667|"     OBJECTIVES      To investigate:        -  the mechanism of Valproic Acid (VPA)-induced apoptosis in B-CLL        -  the ability of VPA in combination with standard chemotherapy or new antitumor agents to          induce a synergistic antitumor effect in chronic lymphocytic leukemia (CLL) cells        -  the clinical efficacy of VPA in previously treated CLL patients.      This will be an example of a translational research study where the results of our laboratory     studies will be applied to a clinical trial in the CLL clinic at CancerCare Manitoba.   "
204362|NCT00524680|"     RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.      PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D     works in treating patients with prostate cancer.   "
210910|NCT00613431|"     The main purposes of this study are to assess the safety and measure the pharmacokinetics of     CS-8080 in healthy volunteers.   "
204364|NCT00524706|"     Introduction:      S-1 is promising drug which could replace 5-fluorouracil plus l-leucovorin (5-FU/l-LV) in     treatment of advanced colorectal cancer.      Phase I/II study of S-1 plus Oxaliplatin (SOX) demonstrated its promising activity with     acceptable toxicity as first-line chemotherapy in patients with untreated metastatic     colorectal cancer and S-1 showed equivalent possibility to 5-FU/l-LV. On the other hand,     phase I/II study of S-1 plus oral Leucovorin (S-1/LV) demonstrated that this regimen had     enhanced efficacy in comparison with S-1 alone. From these results, it was expected that     S-1/LV plus Oxaliplatin (SOL) would be more effective than SOX.      Therefore, phase I/II study of SOL combination therapy was planned.      Purpose A dose-finding study of S-1/LV plus Oxaliplatin (SOL) was planned to determine the     recommended dose (RD), and to assess the response rate (RR) in patients with untreated     metastatic colorectal cancer. The primary endpoints of the phase I portion are determination     of the RD of SOL, and safety.      The phase II portion of this study was aimed to assess the RR of SOL.   "
204365|NCT00524719|"     Distal radius fractures are the most common fracture to occur in the adult population, and     those which are displaced but maintain joint congruity are the most common subtype.     Locking-plate technology represents a true advance in the fixation of these fractures,     especially in view of the ever increasing incidence of these injuries in an ageing and     osteoporotic population throughout Europe and North America. These plates permit rigid     fixation, even in osteopenic bone, while avoiding any tethering of soft tissues, as seen with     external fixation and percutaneous pinning. For these reasons, this mode of fracture fixation     has rapidly gained popularity. Unfortunately, there is presently little evidence to support     their use over the more traditional methods of fixation (percutaneous pinning, external     fixation). In addition, the technique for their application is more invasive and their cost     is considerably greater than these latter two techniques. As such, it is pertinent to     evaluate, in a scientifically sound fashion, the outcome of fixation with the three types of     implant included in this study. The results of this clinical trial will allow the orthopaedic     community to confidently recommend the fixation method which provides the optimal functional,     clinical, and radiographic outcome for a patient suffering a displaced distal radius with     preserved joint congruity.      Null hypothesis: There is no difference in the functional, clinical, and radiographic     outcomes of the three treatment methods.      Hypothesis: Given the locking nature of modern screw-plate constructs, which produce     excellent fixation even in osteopenic bone and permit early range of motion exercises; and     given that plate fixation, in contrast to external fixation and percutaneous pinning, does     not tether muscle, tendon, or capsule; plate fixation with a volar fixed-angle device should     permit earlier and more aggressive rehabilitation and more rapid and complete regain of hand     and wrist function when compared to stabilization with external fixation or percutaneous     pinning.   "
204366|NCT00524732|"     To compare the reactogenicity of ADACEL® vaccine given at intervals of 2 to 9 years with the     reactogenicity of ADACEL® vaccine given at an interval of 10 or more years following the last     previous administration of vaccine containing Diphtheria and Tetanus Toxoids (referred to as     TD/Td).   "
204367|NCT00524745|"     To demonstrate that Gardasil® vaccine, when given to girls 11-13 years of age according to 1     of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months),     results in anti-HPV type 16 and anti-HPV type 18 responses 28 days post-dose 3 that are     similar to those obtained when the vaccine is given on the standard 3-dose schedule of 0, 2,     6 months.   "
204368|NCT00524758|"     To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC)     in glaucoma surgery.      The ologen collagen matrix implantation procedure is same as traditional trabeculectomy     except implant the ologen collagen matrix on the top of sclera flap after one loose stich the     sclera flap. The MMC application is as the standard.   "
204369|NCT00524771|"     The objective of this study is to characterize and compare the risks of short- and long-term     use of NuvaRing® with marketed combined oral contraceptives.   "
204370|NCT00524784|"     Bone marrow transplantation (BMT) has revolutionized the treatment of hematopoietic     malignancies.Unfortunately, graft versus host disease (GvHD) remains a major toxicity that     greatly limits the application and efficacy of BMT.Current standard prophylaxis and therapy     for acute GvHD include mainly the use of immunosuppressive drugs that help less than 50% of     the patients and are associated with increased infection risk. ApoCell treatment is     anticipated to be a prophylactic measure for acute GvHD by inducing tolerance in the donor     effector cells, leading to a potentially significant decrease in GVHD.   "
204371|NCT00524797|"     Myelosuppression (bone marrow suppression) is the most important toxic side effect of the     majority of chemotherapeutic agents and typically is the dose limiting factor. Death     occurring after chemotherapy usually results either from infection related to drug induced     leucopenia or from bleeding related to thrombocytopenia. Colony stimulating factors (CSFs)     are widely used in the treatment of chemotherapy induced neutropenia. The same     Erythropoetines are used in the treatment of chemotherapy induced anemia. Both treatments are     expensive and have several side effects.      In our previous stud (1) we found a special kind of honey: Life-Mel Honey to reduce the     incidence of chemotherapy induced pancytopenia and improving quality of life.      The aim of the recent planed study is to provide prophylactic and protective treatment     against neutropenia reducing the need for secondary CSF administration in patients receiving     chemotherapy along with a natural and non expensive honey: Profonycia.      This honey which is expressed in Kibutz Shamir in Upper Galliee seems promising and easy for     administration: given 5 gr/day per os for 7 days from the administration of chemotherapy.   "
204372|NCT00524810|"     Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin     + Docetaxel in patients with metastatic breast cancer   "
204373|NCT00524823|"     Early detection of prostrate cancer and development of metastases. The research will attempt     to match the SCM test (structuredness of the cytoplasmic matrix) in lymphocytes as an early     cancer detection test using Florescent Activated Cell Sorting (FACS) as a replacement for the     CellScan instrument. The test is based on measurement of cellular changes in response to the     specific prostate antigen, PSA.   "
204374|NCT00524836|"     Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial     Allergic Rhinitis.   "
204375|NCT00524849|"     The primary objective of this study is to evaluate the effects of Zometa (zoledronic acid, 1     mg per week versus 4 mg every four weeks) on the circulating vascular endothelial growth     factor (VEGF) levels in breast cancer patients with bone metastases. Sixty patients will be     randomized into two groups.   "
204413|NCT00517088|"     Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had     already been treated at the Ambulatory of Botucatu School of Medicine were selected. The     measuring tool used for the level of physical activities was the International Physical     Activities Questionnaire (IPAQ-short version), validated by the World Health Organization -     Physical Activities and Health International Committee (1998).   "
211167|NCT00607191|"     To build a DNA repository to enable participation in ongoing and future Clubfoot genetic     linkage studies.   "
204376|NCT00524862|"     Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with     coronary heart disease and LVEF < 40%. Current Canadian guidelines recommend ICDs for primary     prophylaxis in CAD patients with LVEF < 30% (Class I recommendation). There are very sparse     data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will     randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy.     The primary outcome is mortality and the study is powered as a non-inferiority trial to test     the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute     yearly increase) than patients receiving an ICD.   "
204377|NCT00524875|"     The purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is     effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic     patients.   "
204378|NCT00524888|"     To assess the difference in clinical outcome between lacerations in the hand treated by     sutures versus treated by tissue adhesive.   "
204379|NCT00524901|"     This is a phase 2 study that evaluates the effect of intravenous administration of a bolus     EPO on the activation of EPOR-signal transduction cascades and myocardial apoptosis during     cardiopulmonary bypass surgery. Human atrial and ventricular tissue will be collected during     CABG surgery for 3-vessel disease for the assay of EPOR signaling and apoptosis. Two atrial     specimens will be collected before and at the end of cardiopulmonary bypass (CPB).     Concomitantly, two transmural ventricular biopsies will be obtained, at the start and at the     end of CPB. Immediately after obtaining the first atrial biopsy, one bolus of EPO will be     administered intravenously. The atrial tissue will be split and appropriate sections will be     frozen for determination of baseline expression or activity of a number of molecules     including Erk1/2, STAT5, Akt and caspase-3 or embedded in paraffin for immunohistochemistry.     Ventricular tissue will only be processed for immunohistochemistry. Additionally, plasma will     be collected before the procedure and for up to 30 days post-procedure to examine release of     markers of both myocardial ischemia and stress (CK-MB, Troponin T and NT-proBNP) and renal     dysfunction (cystatin C, creatinine for eGFR). Before initializing the randomised study, a     pilot study will be performed with 5 subjects that will not be treated to evaluate the     feasibility of myocardial sample collection. Initiation of the randomised study will only     commence if baseline activity of EPOR-STC can be determined in the atrial tissue and     caspase-3 positive cells can be identified in the second ventricular biopsy.   "
204380|NCT00524914|"     Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations.     We suppose that painful symptoms could be related to the neurotransmitter deficit of PD. So,     we would like to evaluate the involvement of dopaminergic system in nociceptive processing in     PD patients. The objectives of this study is to assess and to compare the effect of a     dopamine agonist administration on the nociceptive threshold and on the cerebral activity     using positrons emission tomography (PET scan) in two groups of PD patients (in 16 painful PD     patients and in 16 pain free PD patients). We hypothesise that dopamine agonist could     normalise nociceptive threshold and cerebral activity which were both abnormal in PD     patients. Moreover, we think that painful PD patients could be more improved by dopamine     agonist than pain free PD patients.   "
204381|NCT00524927|"     This study aims to provide further supportive evidence that Methoxyflurane, a potent     analgesic, administered using the Penthrox Inhaler is safe and efficacious in adult     participants, specifically those who experience incident pain associated with a planned bone     marrow biopsy.   "
204382|NCT00524940|"     Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine,     Northern Hemisphere (NH) 2007-2008 formulation.      Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza     vaccine NH 2007-2008 formulation.      Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics     Evaluation and research (CBER) for further analysis by the Food and Drug Administration     (FDA), the Center for Disease Control and Prevention (CDC), and the World Health Organization     (WHO) to support selection and recommendation of antigen strains for subsequent influenza     vaccines.   "
204383|NCT00524953|"     The primary goal of thos study is to assess safety of Ultraviolet (UV) Phototherapy for the     Prevention of Graft versus Host Disease after allogeneic stem cell transplantation (Phase I -     Clinical trial). Following allogeneic BMT, patients will be placed on standard GVHD     preventive therapy (cyclosporine).      Secondary goals -        -  monitoring immune system recovery        -  the influence of stem cells origin on therapy and/orGVHD prevention        -  the influence of UV-c treatment on survival      clinical data and samples will be collected, during UV-c therapy, 100 days after discharge &     6 months after discharge - to examine the long-term effect of UV-c treatment on the patient's     GVHD status.   "
204384|NCT00516659|"     This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate     the epidemiology of natural infection with ETEC occurring after transcutaneous immunization     in a field setting.   "
204385|NCT00516672|"     This is a two part phase I study in Japanese patients that will determine the safety,     tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination     with lapatinib.   "
204386|NCT00516685|"     The purpose of this study is to determine whether the recombinant human EGF-rP64K/Montanide     ISA 51 vaccine is safe, immunogenic and effective in the treatment of stage IIIb/IV     non-small-cell lung cancer (NSCLC).   "
204387|NCT00516698|"     RATIONALE: Studying changes in breast density and blood hormone levels in women receiving     anastrozole or exemestane for breast cancer may help doctors learn more about the long-term     effects of treatment and may help the study of breast cancer in the future.      PURPOSE: This clinical trial is studying changes in breast density and blood hormone levels     in postmenopausal women receiving anastrozole or exemestane for breast cancer.   "
204388|NCT00516711|"     This study aims to evaluate the attenuation of ischemic-reperfusion injury in the liver after     sevoflurane preconditioning. In the presence of sevoflurane, an attenuation of liver injury     is hypothesized (diminished increase of liver enzymes, reduced production of inflammatory     mediators).   "
204389|NCT00516724|"     The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436     that can be given in combination with carboplatin and/or Paclitaxel chemotherapy   "
204390|NCT00516737|"     The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early     treatment of an acute migraine attack.   "
204391|NCT00516750|"     RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinblastine, doxorubicin, and     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells. Evaluating blood or tissue samples from patients with cancer may     help doctors learn more about changes that occur in DNA, identify biomarkers related to     cancer, and predict how well patients will respond to combination chemotherapy.      PURPOSE: This phase II trial is studying gene expression profiling to see how well it works     in predicting response to treatment in patients with invasive bladder cancer receiving     methotrexate, vinblastine, doxorubicin, and cisplatin.   "
204392|NCT00516776|"     The study includes individuals with ulcerative colitis, Crohn's disease and healthy controls.     The purpose of this study is to examine the innate immune system (IIS) by exposing peripheral     blood monocytes to various ligands relevant for stimulation of the IIS and study the immune     response. Colonic mucosal samples are examined to find gene expression patterns which may     distinguish the two forms of disease from each other and from healthy controls.      The hypothesis is that the innate immune system has responses unique for the disease states,     and that the diseases may be differentiated by examination of gene expression patterns in     mucosal biopsies.   "
204393|NCT00516802|"     This is a Phase I, open-label, dose-escalating, study of the safety and tolerability of     KU-0059436 in combination with DTIC in the treatment of patients with advanced melanoma who     have not previously received systemic cytotoxic chemotherapy.   "
204394|NCT00516828|"     RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth or by blocking blood flow to the cancer. Drugs used in chemotherapy,     such as cytarabine, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving sorafenib together with     cytarabine may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib     together with cytarabine and to see how well it works in treating older patients with acute     myeloid leukemia or high-risk myelodysplastic syndrome.   "
204395|NCT00516841|"     To evaluate the efficacy of voloxicimab when administered at 15 mg/kg qwk in subjects with     platinum-resistant, advanced epithelial ovarian cancer or primary peritoneal cancer.   "
204396|NCT00516854|"     Non-cardiac chest pain is a common clinical problem encountered in our practice but at     present, the results of treatments are unsatisfactory. The pathogenesis remains unknown but     altered motility of the esophagus and psychological factors including anxiety have been     implicated as important factors. Reports of the single use of anticholinergic drugs and     anxiolytics have yielded conflicting results, has been demonstrated to yield marginal or of     no value. However the use of the combination therapy, especially with a double blind fashion     have not been reported. On that basis, we propose to use a combination of anti-cholinergic     and tranquilliser for the symptomatic treatment of non-cardiac chest pain. The aim of this     study is to evaluate the efficacy of combination therapy of anti-cholinergic and anxiolytic     drugs in the treatment of non-cardiac chest pain.   "
204397|NCT00516867|"     We would investigate in a controlled, randomized open study in the winter season: 1) If serum     levels of vitamin D (25(OH)D) increase in subjects treated with sunbed with sunlamps emitting     mainly UVA and only 0·5% or 1·4% UVB compared to non-sunbed treated controls 2) If yes, are     the 25(OH)D serum levels then dependent on the UVB dose?   "
204398|NCT00516880|"     Peritoneal dialysis patients are at increased risk of cardiovascular morbidity and mortality     and are related to the presence of accelerated atherosclerosis. Our recent data showed that     inflammation predicts mortality and cardiovascular death, independent of other cardiovascular     risk factors in peritoneal dialysis patients. As a considerable proportion of peritoneal     dialysis patients showed evidence of inflammation, it raises an important question as to     whether anti-inflammatory treatment has any cardiovascular and survival benefit in these     patients. The peroxisome proliferator-activated receptor-gamma (PPAR-g) agonist is a class of     drug with insulin sensitizing property. Recent experimental and clinical studies demonstrated     that this class of drug has anti-inflammatory and anti-atherosclerotic properties other than     insulin sensitizing effect in type 2 diabetics. We therefore hypothesize that modulation of     the PPAR-g activity may be a novel therapeutic strategy for reducing inflammation and     retarding the progression of atherosclerosis and possibly lowering mortality in our     peritoneal dialysis patients.   "
204399|NCT00516893|"     The primary objective of the study was to evaluate the immunogenicity of natalizumab     (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E)     administered intravenously (IV) to participants with relapsing forms of multiple sclerosis     (MS). The secondary objective of this study was to evaluate the safety of natalizumab high     titer.   "
204400|NCT00516906|"     Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV     Dressing   "
204401|NCT00516919|"     This is a research study designed to examine the effectiveness of an obesity medication     (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese     monolingual (Spanish-speaking only) men and women.   "
204402|NCT00516932|"     This study will identify variations in genes that may be involved in the development of     suicidal events or certain behaviors in youth who are exposed to antidepressant medications.   "
204403|NCT00516945|"     Patients with non-lymphoma and non-leukaemia cancer who are also hepatitis B carriers will     have a risk of hepatitis B reactivation during chemotherapy. Lamivudine can be used     effectively to control hepatitis upon reactivation during chemotherapy and the chemotherapy     may not need to be interrupted. The study aims to investigate whether adding the anti-viral     drug Lamivudine at the start of chemotherapy for all patients, rather than at the time of     hepatitis reactivation for those with reactivation, will help to improve the delivery of     chemotherapy in these patients.   "
204404|NCT00516958|"     To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs.     Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.   "
204444|NCT00517491|"     The purpose of the protocol is to evaluate the correlation between plasma lanreotide levels     and Growth Hormone (GH)/Insulin Like Growth Factor 1 (IGF-1) dynamics and clinical     improvement in patients with acromegaly treated with lanreotide Autogel (Somatuline ATG)   "
204405|NCT00516971|"     The purpose of this study is to evaluate the efficacy of proton pump inhibitor for the     treatment of non-erosive reflux disease (NERD) in Chinese population. Studies from the     western population have estimated a worldwide prevalence of gastro-oesophageal reflux disease     from 10 to 20 %. Monthly symptoms of heartburn or acid regurgitation were found in 9.3% of     subjects according to a population survey in Hong Kong. Most of these patients did not show     evidence of erosive change during upper endoscopy. However, patients with NERD suffer from     similar impairment of quality of life as patients with erosive oesophagitis and their     symptoms are as severe as patients with erosive disease. Data on the use of proton pump     inhibitor for the treatment of NERD in Chinese patients are scanty. Thus we want to perform a     double-blind randomised placebo-controlled study to evaluate the efficacy of proton pump     inhibitor for the treatment of NERD in Chinese population.   "
204406|NCT00516984|"     The relationship between Osteopathic Manipulative Therapy (OMT) and the autonomic nervous     system is poorly understood. This study quantifies that relationship and demonstrates a cause     and effect. It is hypothesized that cervical myofascial release increases vagal tone.   "
204407|NCT00517010|"     Because a possible synergism of radiation and inhibitors of vascular endothelial growth     factor has been shown in cancer patients and patients with wet macular degeneration, this     pilot study is being conducted to determine whether treating wet macular degeneration with a     combination of Lucentis and proton beam irradiation is safe. Lucentis is an inhibitor of     vascular endothelial growth factor which was recently FDA approved for treatment of wet     macular degeneration. It appears to be the most effective therapy thus far for wet macular     degeneration among all drugs FDA approved for this condition. If no major safety issues are     associated with this combination therapy, a larger study will be conducted to determine     whether this combination therapy is more effective than Lucentis monotherapy.   "
204408|NCT00517023|"     Syncope (commonly called collapses or blackouts) is defined as loss of consciousness which is     transient, self limiting and usually leads to falling.      While the causes of syncope encompass a wide variety of factors, those due to heart rhythm     abnormalities are acknowledged to be significantly more serious compared with other causes.      The main aim of the study is to see if it is possible to find the cause of a patient's     syncope faster using a device called an implantable loop recorder (ILR), which is implanted     under the skin, versus conventional management. The device is slightly larger than a 50 pence     coin and records the rhythm of the heart continuously.      Although ILRs are being used widely today, we want to use a new model that is able to relay     information to the doctor via wireless technology and internet.      We also want to use ILRs earlier in diagnosing syncope, thereby avoiding unnecessary and     lengthy hospital admissions and lowering cost.      Primary aim: To see how soon the ILR detects abnormal heart rhythms or normal ones (in study     subjects who faint/ suffer syncope).      Secondary aims are:        1. To see how soon treatment is started once the abnormal rhythm is detected by the ILR.        2. To see which group (patients with ILRs or those receiving conventional tests) receives          treatment sooner.        3. To see which group has less subsequent collapses i.e has benefited from appropriate          treatment sooner.        4. To assess the cost effectiveness of using the implantable loop recorder more as a          diagnostic tool for syncope versus conventional management (it should save many hospital          admissions).   "
204409|NCT00517036|"     This study will test the effectiveness of two different kinds of omega-3 fatty acid dietary     supplements in treating the symptoms of major depression.   "
204410|NCT00517049|"     This Phase II, single-arm, open-label, multicenter trial is designed to evaluate the safety,     efficacy, and pharmacokinetics of PRO95780 when combined with rituximab in patients with     follicular, CD20-positive B-cell NHL that has progressed following previous rituximab     therapy.   "
204411|NCT00517062|"     Study hypothesis:      Growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor     (IGF)-I, can improve insulin sensitivity in adults with GH deficiency.      Study aims:      The purpose of this study is to determine the mechanism of how low dose GH treatment affects     the body's sensitivity to insulin actions and whether this low GH dose can affect the body's     handling of steroid hormone levels (cortisol clearance) in adults with GH deficiency.      Study design:      Men and women with confirmed GH deficiency, but not recently been on GH treatment will be     invited to participate in this study. The subjects will be assessed at the initial visit to     ascertain their suitability before further participating in the study. If suitable, an equal     number of men and women will be randomized to receive either low dose GH or placebo injection     for 3 months. Before, during and after treatment, the subjects will be assessed at regularly     with blood tests, scans and fat biopsies. At the first and final visit, testing will include     scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver;     blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to     measure the density of IGF-I in the muscle; whereas blood tests to examine insulin     sensitivity will also be collected. This study will use Genotropin and Genotropin pen     devices, and the the data will be analyzed using a computer statistical program where the     identity of the subjects will be coded to maintain confidentiality.   "
204412|NCT00517075|"     This study will test whether repetitive transcranial magnetic stimulation (rTMS) is helpful     in treating negative symptoms and social deficits of schizophrenia. This will be the first     rTMS study to assess social function and social cognition.        1. Hypoactivity in the dorsolateral prefrontal cortex (DLPFC) has been implicated in          generating the negative symptoms of schizophrenia. Abnormalities in the left inferior          parietal lobe (IPL) have also been associated with negative symptoms. We hypothesize          that high frequency rTMS applied to the hypoactive left DLPFC or to the left IPL in          individuals with schizophrenia will reduce negative symptom severity more than sham          (placebo) rTMS as assessed by the Positive and Negative Syndrome Scale (PANSS) negative          symptoms subscale.        2. We hypothesize that high frequency rTMS applied to the left DLPFC or to the left IPL in          schizophrenia patients will improve social dysfunction more than sham (placebo) rTMS as          assessed by the Social Adjustment Scale, the Social Adaptation Self-Evaluation Scale and          the Social Functioning Scale.   "
204445|NCT00517504|"     The purpose of this study is to determine if methylphenidate (a common brand name is     Ritalin), a medicine used for treating older children with Attention Deficit and     Hyperactivity Disorder (ADHD), is also safe and helpful for problems related to symptoms of     ADHD in young children with Developmental Disorders (DD)   "
204414|NCT00517101|"     A relationship between IBD and spondyloarthropathy is well recognized. ASCA ( anti     saccharomyces cerevisiae antibodies)are considered to be a serological marker for Crohn's     disease and have been studied in patients with spondyloarthropathy with conflicting results.     More recently, new serological markers for IBD have been described. These markers are     antibodies to certain defined glycans , and their use may permit an improved diagnosis of     IBD.      The aim of our study is to investigate wether these new serological markers are present in     the sera of patients with spondyloarthropathy.   "
204415|NCT00517114|"     The purpose of this study is to evaluate the efficacy of rabeprazole (pariet) versus placebo     in treating reflux laryngitis in Chinese patients. Patients who attend the voice clinic of     Department of ENT, Queen Mary hospital with suspected reflux laryngitis will be recruited. A     questionnaire will be administered by the research assistant of the Department of Medicine     and ENT, Queen Mary hospital. A 12-week course of PPI versus placebo trial will be commenced     and patients' symptoms and signs will be documented at 6-week and 12-week time. The study     will finish after a 12-week course of rabeprazole.   "
204416|NCT00517127|"     The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid     management leads to less perioperative morbidity compared to crystalloid-based goal-directed     intraoperative fluid management. Goal-directed therapy is based on measurements by an     Esophageal Doppler Device.   "
204417|NCT00517140|"     The incidence of caesarean section has reached 15-20% in most developed countries.     Encouraging vaginal birth after caesareans section (VBAC) has been considered a key component     of a strategy to reduce the caesarean section rate. Most medical literature has focused on     the efficacy of VBAC in reducing the caesarean section rate and the physical safety of     successful VBAC. However, 30%-40% of these women fail to achieve a vaginal delivery. Little     is known about how the uncertainty of labour outcome and a failed VBAC impact on the     psychosocial function of these women. We propose to study a cohort of women with a prior     caesarean section and presenting with a subsequent pregnancy for care. After consent and     recruitment, these subjects will be randomly assigned to have a repeat caesarean section or     VBAC. The medical outcomes, overall satisfaction of the subjects with the care they received,     and the short-term psychosocial function of these subjects will be studied. The result of     this study will provide important information that would be useful in assisting women to     decide the mode of delivery after a prior caesarean section.   "
204418|NCT00517153|"     This is a phase II randomized controlled study of miglustat in adult and juvenile patients     with Niemann-Pick Type C disease. Up to 42 patients will be randomised in a 2:1 ratio to     either treatment with miglustat or to a non-treatment group. Both groups will follow an     identical visit schedule.   "
204419|NCT00517166|"     Data will be collected on the type of tourniquet and circumstances of its use. Patients with     penetrating extremity injury will have clinical and pre-clinical hospital data collected.   "
204420|NCT00517179|"     The purpose of this study is to investigate the interaction between doxazosin GITS and     vardenafil on blood pressure (Both systolic and diastolic blood pressure) in patients with     both ED and BPH.   "
204421|NCT00517192|"     The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir     (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600     mg /100 mg twice daily) in combination with investigator selected optimised background     regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI),     Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI))     treatment-experienced (a minimum of 3-months duration for each class) with resistance to more     than one PI on the screening virtual phenotype resistance testing.   "
204422|NCT00517205|"     The purpose of this research is to assess the role of non-contrast helical computerized     tomogram in predicting the treatment outcome of upper ureteric stone by extracorporeal shock     wave lithotripsy (ESWL).   "
204423|NCT00517218|"     To compare the efficacy and safety of combination treatment with Genasense, fludarabine, and     rituximab versus combination treatment with fludarabine and rituximab in previously untreated     subjects with CLL.   "
204424|NCT00517231|"     Tuberculosis is a highly prevalent chronic infectious disease caused by Mycobacterium     tuberculosis. Cytokines are important biological mediators that regulate immune and     inflammatory responses against the bacilli, witch include the acute phase response. Besides     this, it becomes essential to determine markers of healing lesions, once this is currently     carried out based on the clinical, radiological, and negative bacterioscopy.   "
204425|NCT00517244|"     This study will look at similarities and differences in family processes and child     temperament among children with and without symptoms of anxiety disorders.   "
204426|NCT00517257|"     The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision,     when compared to placebo   "
204427|NCT00517270|"     Non-cardiac chest pain accounts for 2-5% of all emergency presentations. In the United     States, it has been estimated approximately that US$8 billion was spent annually for the     initial care of patients suspected to have an acute coronary syndrome, but who were     subsequently found not to have coronary artery disease (1). The most common cause of     non-cardiac chest pain is gastro-oesophageal reflux disease (2). Two randomized,     double-blind, placebo-controlled trials on the use of omeprazole versus placebo for the     treatment of NCCP have been published in the western population and reported an efficacy of     62% to 80% (3,4). High-dose omeprazole was used in the previous trials (3,4). Recently, it     has been shown that rabeprazole, which is a newly developed benzimidazole proton pump     inhibitor, is a more potent and rapid inhibitor of H+,K+-ATPase and acid secretion than     omeprazole, lansoprazole and pantoprazole (5,6). Whether the above findings applied to     Chinese population is unknown. Thus we would like to propose a randomized double-blind     placebo-controlled trial to study the effects of high-dose proton pump inhibitor for the     treatment of non-cardiac chest pain in Chinese population. The aim of this study is to     evaluate the efficacy of high-dose proton pump inhibitor for the treatment of     gastro-oesophageal reflux related non-cardiac chest pain.   "
204515|NCT00530348|"     The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™)     as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with     subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had     not previously received MS disease-modifying therapies. Participants had monthly laboratory     tests and comprehensive testing every 3 months.   "
204428|NCT00517283|"     As exenatide slows the rate at which materials leave the stomach, it is likely to alter the     rate of intestinal absorption of oral drugs when administered within a certain timeframe     relative to exenatide. In addition, the residence time within the stomach of other medication     may be prolonged and data from this study will help assess the change in residence time in     the presence of therapeutic doses of exenatide. This study will also evaluate the     relationship between blood levels of exenatide and parameters measuring rate of stomach     emptying.   "
204429|NCT00517296|"     This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can     improve durable fistula healing in patients with Crohn's perianal fistulas and to get     preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal     fistulas.   "
204430|NCT00517309|"     The primary purpose of the study is to test the safety of HPV Vaccine in Women   "
204431|NCT00517322|"     Aim of the study is to compare in hypertensive patients the effect of one year therapy with     ACE-inhibitor (RAMIPRIL) or angiotensin II receptor blocker (IRBESARTAN) on left atrial     remodelling and diastolic function.   "
204432|NCT00517335|"     This study will compare the brain's ability to distinguish between natural and artificial     sweeteners in women with and without a history of eating disorders.   "
204433|NCT00517348|"     To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMA-026     administered subcutaneously (SC) or intravenously (IV) in healthy adults.   "
204434|NCT00517361|"     The purpose of this study is to determine the progression free survival (PFS) of metastatic     ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab     (Avastin®) therapy.   "
204435|NCT00517374|"     To establish a solid foundation, e.g. a network and a coordinating centre for testing new SCI     therapies in forthcoming randomised controlled multi-centre clinical trials following     international standards and guidelines.   "
204436|NCT00517387|"     Recently published work has examined the effects of atypical antipsychotics in     SSRI-treatment resistant patients. In these studies, patients with unipolar depression who     were treated with SSRI's, but not responsive to treatment after 4 or more weeks, were     supplemented with an atypical. The atypical antipsychotics were found to diminish depression     symptoms, as well as benefit sleep quality.      We propose a similar study with Quetiapine XR, focusing on thinking processes, mood and     anxiety. Patients with depression who are SSRI treatment resistant will be treated with     Quetiapine. Cognition will be evaluated in the UBC Mood Disorders Clinic two times: first     before Quetiapine addition, then after 8 weeks. Depression symptoms and other measurements     will be done at the 9 time points: before Quetiapine, and each week after treatment has     begun.      The primary purpose of this study is to evaluate the superiority of Quetiapine XR compared to     placebo as augmentation therapy in treatment of anxiety and depressive symptoms in     SSRI-nonresponsive unipolar patients. Secondarily, we would like to evaluate the safety and     tolerability of quetiapine as augmentation therapy in SSRI-nonresponsive unipolar patients.   "
204437|NCT00517400|"     Evaluation of the novel deep TMS H-Coil designs as a treatment measure in post traumatic     stress disorder (PTSD).      Comparing real to sham treatment.   "
204438|NCT00517413|"     This single arm study will assess the efficacy and safety of Mircera when administered once     monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in     dialysis patients with chronic renal anemia. Patients currently receiving maintenance     treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose     (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the     week preceding study start. The anticipated time on study treatment is 3-12 months, and the     target sample size is 100-500 individuals.   "
204439|NCT00517426|"     To evaluate the effects of CO2 inhalation and acetazolamide treatment on exercise-induced     periodic breathing in patients with chronic stable heart failure.      Patients will be given CO2 (2%) during a constant workload exercise. Patients will be also     evaluated by maximal cardiopulmonary exercise test without and with acetazolamide acute and     chronic treatment.   "
204440|NCT00517439|"     This 7 arm study will determine the optimal treatment combination, based on efficacy and     safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7     treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV     polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or     180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24     weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus     1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus     PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks,     those achieving a rapid virological response (RVR) will stop all medication, and non-RVR     patients will remain on triple combination for an additional 24 weeks. Group 7 will receive     standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free     follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months,     and the target sample size is 100-500 individuals.   "
204441|NCT00517452|"     The use of platelet rich plasma will decrease wound infection postop.   "
204442|NCT00517465|"     This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and     tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2     diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose     will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid     for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability,     pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study     treatment is <3 months, and the target sample size is <100 individuals.   "
204443|NCT00517478|"     Determine usefulness of thromboelastography (TEG) as a valuable tool in ex-vivo assessing     platelet response to aspirin and clopidogrel (dual) treatment and on-treatment platelet     reactivity during acute ST segment elevation myocardial infarction (STEMI) in an acute phase     during primary PCI (PPCI) and also during recovery been on maintenance medical therapy and to     determine the correlation between platelet response to clopidogrel treatment and the outcome     of patients.   "
204598|NCT00531479|"     This study compares the effectiveness and safety of the combination of anidulafungin and     voriconazole compared to that of voriconazole alone (which is generally considered the     standard of care) for the treatment of Invasive Aspergillosis.   "
204446|NCT00517517|"     The objectives of this Phase I/II study are to assess the safety and immunogenicity of two     different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult     population. Subjects will be randomized 1:1 to receive two intramuscular injections (21 days     apart) of the vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in     a non-adjuvanted formulation. Subjects will be monitored for safety and for antibody response     to the vaccine. A data safety monitoring board will review the safety data after the first     and second vaccination.   "
204447|NCT00517530|"     The primary objective for the phase I part of the study is to investigate the safety and     tolerability of escalating intravenous (IV) doses of obinutuzumab given as monotherapy in     participants with CD20+ (tumor-infiltrating lymphocytic) Malignant Disease, including B-cell     chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL). The primary objective     for the phase II part of the study is to investigate the efficacy and safety of one dose of     obinutuzumab in participants with relapsed/refractory CLL and NHL that is, in turn, either     indolent (iNHL) or aggressive (aNHL).      It is an open label dose escalating study in phase I and open label in phase II, but the two     doses in iNHL & aNHL are randomized (to high or low dose of the same open label treatment).     CLL was not randomized as only one dose level was used.      Participants with a response who might gain additional benefit from being treated again in     the opinion of the investigator may be enrolled in a Retreatment Period.   "
204448|NCT00517543|"     This study is being conducted to measure the amount of study drug that is in your blood after     you receive a different type of tablet in each of four study visits.   "
204449|NCT00517556|"     The primary hypothesis is that continuous administration of an OCP (CCOCP regimen) will     result in more pain relief than a traditional 21/7 administration in primary dysmenorrhea     (PD) patients.   "
204450|NCT00517569|"     The purpose of this study is to assess the safety of GX-12 gene therapy combined with HAART     in the HIV-1 infected patients and to investigate the efficacy with the value of plasma viral     load and with CD4 counts and HIV-1 specific IFN-gamma expressed T-lymphocytes   "
204451|NCT00517582|"     Individuals with heart disease or high blood pressure are often prescribed angiotensin     converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors     can be associated with angioedema, a rare but life-threatening condition that causes swelling     of the face and other body parts. This study will evaluate the effectiveness of the drug     HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who develop the     condition.   "
204452|NCT00517595|"     The primary objective is to determine the progression free survival with pemetrexed, and     gemcitabine plus bevacizumab as first-line chemotherapy in elderly patients with Stage     IIIB/IV non-small cell lung cancer (NSCLC).      The secondary objectives are to determine the overall response rate; overall survival;     chemotherapy induced toxicity profile of this combination; time to progression; and patient     reported symptom burden.   "
204453|NCT00517608|"     Monopolar electro surgery scissors (MES), electro thermal bipolar vessel sealer (BVS) and     ultrasonically coagulating shears (UCS) are all applied in laparoscopic colorectal surgery.     We aimed to compare the different devices with regard to dissection time, blood loss,     technical aspects and costs.        -  Trial with surgical intervention   "
204454|NCT00517621|"     validation of a french version of FACT-GOG/NTX and using this questionnaire to evaluate the     incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with     paclitaxel associated or not with EPO.   "
204455|NCT00517634|"     The aim of the present study is to investigate whether the effects of salmeterol in     combination with fluticasone propionate on blood markers of airway inflammation are     maintained after chronic dosing and whether the effect is influenced by the time of allergen     challenge relative to the time of dosing.   "
204456|NCT00517647|"     The purpose of this study is to determine if atomoxetine (a common brand name is Strattera),     a medicine that is used for treating older children with Attention Deficit and Hyperactivity     Disorder (ADHD), is also safe and helpful for ADHD problems in young children. While     atomoxetine is not approved by the FDA for use in children younger than 6 years, the FDA has     given permission to study this drug in this age group.   "
204457|NCT00517660|"     To characterise the physical parameters (number concentration, size distribution and their     trajectories) of aerosols (droplets) generated in high risk procedures.   "
204458|NCT00517673|"     GSK945237 is the first molecule of a new chemical class that is being developed for treatment     of respiratory tract and other infections such as skin and soft tissue. This study drug has     been tested in animals but has never been given to humans. This is a two part study. The     purpose of the first part is to study the side effects of this drug in humans, and to study     how much of the drug gets absorbed in the blood stream The second part of this study will     compare absorption of the study drug in the blood stream when given with food and when given     under fasting conditions   "
204459|NCT00517686|"     The primary research question of this study is to determine whether measuring, reporting and     feeding back information to primary care teams on the need for treatment intensification in     patients at high risk for cardiovascular disease (CVD) can improve rates of treatment     intensification and reduce levels of poorly controlled systolic blood pressure, LDL-c, and     A1c.   "
204460|NCT00524966|"     RATIONALE: The use of bipolar energy sealing system or ultrasonic coagulation for hemostasis     during thyroidectomy may reduce blood loss and hypocalcemia and may be more cost-effective.   "
204461|NCT00524979|"     There is a differences in voice frequency of schizophrenic patients compared to patients with     other mental diseases and compared to mentally healthy people.   "
204473|NCT00525148|"     The primary objective of this open-label, single arm Phase II trial is to explore the     efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by RECIST     criteria in patients with advanced NSCLC Stage IIIB or IV whose tumors harbor activating     mutations within exon 18 to exon 21 of the EGFR receptor. Patients progressing or relapsing     after one prior cytotoxic chemotherapy regimen as well as chemotherapy naïve patients (only     in stage 2) will be allowed to enter into the trial.   "
204474|NCT00525161|"     The purpose of this study is to determine the clinical response rate to sorafenib when added     to existing endocrine therapy in patients with advanced breast cancer.   "
204462|NCT00524992|"     This study will examine the following: 1) how common albuminuria and proteinuria are among     HIV-positive patients, 2) what causes albuminuria or proteinuria in these patients and 3)     whether the condition becomes more severe over time. HIV-infected people are more likely than     others to develop kidney disease. The earliest indicator of the possible presence of kidney     disease is albuminuria (increased amounts of the protein albumin in the urine). A later     indicator is the appearance of other proteins, a condition called proteinuria.      HIV-infected patients 8 years of age and older who do not have diabetes, chronic kidney     disease or cancer may be eligible for this study.      Participants provide a urine sample during three visits as follows: the first upon enrollment     in the study, a second 3 months later, and a third about 6 months after that. Blood samples     are drawn at the first and last visits. At the first visit a medical history is taken and     blood pressure, height, weight, waist circumference, hip circumference and upper arm skin     thickness are measured.      Participants who are found to have albuminuria or proteinuria are asked to undergo a kidney     biopsy for research purposes. The procedure is optional. Participants who develop heavy     proteinuria may be recommended to undergo a kidney biopsy in order to determine the nature of     the kidney disease and begin treatment. The biopsy requires a 2-day hospital stay. For the     procedure, an anesthetic is given to numb the skin and a needle is inserted and guided into     the kidney to withdraw a small tissue sample. The needle is passed twice, and possibly three     times. Following the procedure, the subject remains in bed rest for at least 10 hours to     minimize the risk of excessive bleeding....   "
204463|NCT00525005|"     The purpose of this study is to determine the efficacy of combination of docetaxel,     oxaliplatin, and S-1 (DOS) in the treatment of advanced gastric cancer.   "
204464|NCT00525018|"     Patients with peripheral neuropathy frequently exhibit treatment-refractory neuropathic pain.     Although both peripheral and central determinants are recognized for the pathophysiological     basis of neuropathic pain following peripheral injury, the modulating effect on pain     processing in brain by peripheral mechanisms remains elusive. Here, we will systematically     compare the sensory symptoms and brain activation to painful heat stimulation applied to the     foot dorsum between patients with peripheral neuropathy and healthy controls. Functional     magnetic resonance imaging will be used to define brain activation to thermal stimulation     with noxious heat and innocuous warm thermal stimuli applied by contact heat stimulator.     Brain activation during thermal stimulation in patients with neuropathic pain will be     clarified, and we will also analyze the potential relationships between the topography,     quality and intensity of the different painful symptoms and the magnitude and pattern of     brain activation during thermal stimulation. This will add in our understanding in the     pathophysiology of brain modulation in pain and provide clinically useful message toward the     potential therapeutics in the management of neuropathic pain.   "
204465|NCT00525031|"     The goal of this clinical research study is to learn if temozolomide alone or given with     pegylated interferon alpha-2b can help to control metastatic melanoma. Researchers also want     to study the safety of these 2 treatments.      Objectives:        1. To determine the anti-tumor activity (pathological response CR+PR) and toxicity of          temozolomide (TMZ) alone or in combination with pegylated interferon alpha-2b (PGI) in          patients with resectable stage IIIC or stage IV (M1a) metastatic melanoma prior to          definitive surgical resection.        2. To determine the relapse-free survival, overall survival and the impact of tumor          response to chemotherapy in these patients.        3. To differentiate the in vivo treatment effects of TMZ alone vs.TMZ plus PGI and          correlate with clinical outcome by analysis the pre- and post-treatment tumors and          peripheral blood mononuclear cells with respect to:      1) Known cellular and molecular markers of apoptosis and cell proliferation, 2) Promotor     methylation status of the DNA repair enzyme O6-methylguanine-DNA methyltransferase (MGMT), 3)     DNA sequence variability of tumor suppressor genes and DNA repair enzymes, 4) Tumor genomic     expression profiles analysis by complementary DNA (cDNA) microarray and protein array   "
204466|NCT00525044|"     The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg     in the treatment of sore throat in patients with acute viral pharyngitis.   "
204467|NCT00525057|"     The primary endpoint of the study would be to determine the safety of dalteparin as     prophylaxis against deep venous thrombosis (DVT) in orthopaedic oncology patients.     Specifically, the goal of the study is to determine whether there are significantly increased     bleeding complications at the surgical site after major oncologic operations in the lower     extremity. The study would help establish specific parameters for use of dalteparin in     complex orthopaedic oncology patients. Not all patients would be appropriate for this     medication, particularly those with massive hemorrhage during surgery and those with     underlying coagulopathies. It is likely that patients requiring limited tumor excision,     particularly those with metastatic carcinoma, would be ideal candidates for dalteparin     therapy. Patients who require radical resections of tumor may need stricter guidelines for     the safe use of the medication, since the potential for post-operative bleeding may be     greater.   "
204468|NCT00525083|"     Coronary heart disease (CHD) is the single leading cause of death in the United States .     Serum Cholesterol is known to have a direct impact on a number of human diseases through a     variety of mechanisms. This is particularly true of cardiovascular disease. Measurement and     manipulation of serum cholesterol has become a primary focus of primary care physicians and     cardiologists when attempting to reduce risk of heart disease.   "
204469|NCT00525096|"     To discover if the adding of a coxib increases the efficacy of the Aromasine.   "
204470|NCT00525109|"     The purpose of this study is to determine the genetic basis of one family's hereditary     hyper-HDL-emia using multiple modalities such as linkage analysis and gene array.   "
204471|NCT00525122|"     Hypothesis: What is the natural course after treatment with radioactive iodine in patients     with hyperthyroidism?      What are the determinants for the development of acute hypo- or hyperthyroidism after     treatment with radioactive iodine without antithyroid drugs?   "
204472|NCT00525135|"     RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive,     which will allow for detection of tumor and make further ablation treatment effective.   "
204517|NCT00530374|"     The purpose of this study is to determine the safety profile of oral iron supplementation     (OIS) with Sprinkles in a pediatric population with high prevalence of Iron deficiency (ID)     and moderate or severe malnutrition (MSM); the efficacy profile will also be investigated.   "
204475|NCT00525174|"     This study is a randomized clinical trial designed to evaluate the non-inferiority of     Bangerter filters compared to 2 hours of daily patching as a primary treatment for moderate     amblyopia (20/40 to 20/80) in children ages 3 to < 10 years.      Secondary objectives of this study are (1) to determine the time course of visual improvement     with Bangerter filter treatment, (2) to compare patient quality of life, measured by a     modified Amblyopia Treatment Index, between patients treated with patching vs. Bangerter     filters, (3) to determine whether blurring the sound eye to a visual acuity worse than the     amblyopic eye predicts improvement in acuity, and (4) to determine whether a change in     fixation to the amblyopic eye is predictive of improvement in visual acuity.      The primary outcome assessment is visual acuity at 24 weeks for both the amblyopic and sound     eyes.      The primary analytic approach for the amblyopic eye acuity will involve construction of a     one-sided 95% confidence interval to assess non-inferiority based on a treatment group     comparison of logMAR visual acuity scores adjusted for baseline visual acuity scores in an     analysis of covariance (ANCOVA) model.      Sound eye acuity data will be reported for each treatment regimen at the 24-week visit as     mean change (logMAR lines) from baseline and as the distribution of the number of lines of     change from baseline.   "
204476|NCT00525187|"     The prevalence of onychomycosis among diabetic patients is still a debated question as well     as the best way to diagnose the disease. We conducted a prospective study to assess the     prevalence of onychomycosis in diabetic neuropathic (DN) patients clinically suspected of     this disease and to assess the reliability of the diagnosis of onychomycosis.   "
204477|NCT00525200|"     Study Hypothesis:      PANCHO is a prospective randomized, predictive marker study, evaluating the interaction     between the potential predictive marker 'p53 genotype' and response to induction chemotherapy     in patients with esophageal cancer considered resectable.      170 patients with measurable disease will be enrolled in this study. After testing the marker     genotype (two genotypes: p53 normal or p53 mutant) patients will be stratified according to     histological subtype only (adeno- or squamous cell carcinoma) and will be randomly assigned     to receive 3 cycles of either 5-fluorouracil (5FU)/cisplatin or docetaxel monotherapy as     neoadjuvant therapy. All patients will be rendered to subsequent surgery in order to assess     both clinical and pathohistological response.   "
204478|NCT00525213|"     The primary objective of this study is to evaluate the efficacy (ACR20) of Rob 803     administered orally once daily for 12 weeks in combination with a stable dose of methotrexate     in subjects with moderate or severe active RA.   "
204479|NCT00525226|"     This study will evaluate pregnant women with a past or current diagnosis of depression or     anxiety to gain a better understanding of how these disorders can affect an infant's     development, both during and after pregnancy.   "
204480|NCT00525239|"     Hypothesis 1: Ritonavir-based regimens increase triglycerides and VLDL by both increasing     VLDL production and decreasing VLDL clearance.      Specific Aim 1A: To quantify the effect of ritonavir on VLDL production and clearance using     stable isotope turnover and other clearance methods.      Specific Aim 1B: To determine the composition of the triglyceride rich particles.      Protocol 1: The effects of ritonavir-based regimens on VLDL production, VLDL clearance and     triglyceride-rich lipoprotein composition in healthy normal volunteers. HIV-seronegative     volunteers will be studied before and at the end of four weeks of taking ritonavir,     lopinavir/ritonavir or atazanavir/ritonavir.      Hypothesis 2: NNRTI drugs do not increase HDL by increasing apo AI production, but rather by     decreasing apo AI clearance, prolonging time in circulation.      Specific Aim 2A: To determine the composition of HDL before and after NNRTI and assess its     function.      Specific Aim 2B: To quantify the effect of NNRTI on apo AI production and clearance using     stable isotopes.      Specific Aim 2C: To determine if the NNRTI induced increase in HDL is accompanied by     improvement in flow mediated vasodilation and circulating markers of endothelial function     Protocol 2A: The effects of efavirenz on HDL composition, HDL function, apo AI production,     apo AI clearance, flow mediated vasodilation and circulating markers of endothelial     dysfunction in healthy normal volunteers. HIV-seronegative volunteers will be studied before     and at the end of six weeks of taking efavirenz.      Protocol 2B: The effects of starting an efavirenz-based regimen on HDL composition, HDL     function, apo AI production, apo AI clearance, flow mediated vasodilation and circulating     markers of endothelial dysfunction in patients with HIV infection. HIV-infected patients     whose care providers have prescribed an efavirenz-based regimen will be studied before and     after six weeks of starting efavirenz.      Hypothesis 3: Ritonavir-based PI regimens impair insulin secretion. Specific Aim 3: To     determine which ritonavir-based PI regimens alter insulin secretion.      Protocol 3: The effects of ritonavir-based regimens on insulin secretion in healthy normal     volunteers. HIV-seronegative volunteers will be studied before and at the end of four weeks     of taking ritonavir, lopinavir/ritonavir or atazanavir/ritonavir.   "
204481|NCT00525252|"     Intervention to achieve alcohol abstinence represents the most effective treatment for     alcoholic patients with liver cirrhosis. However no trials have evaluated the efficacy of     anti-craving drugs in these patients because of the concern that these medications might     worsen liver disease. Baclofen is effective to reduce alcohol craving improving abstinence in     alcohol-dependent patients. It is mainly eliminated by kidney. No hepatic side-effects have     been reported in treated patients. The present study investigates the efficacy and safety of     baclofen in achieving and maintaining abstinence in alcoholic cirrhotic patients.   "
204482|NCT00525265|"     To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake),     efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic     ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in     congestive heart failure (cardiac edema) patients with extracellular volume expansion despite     the use of a diuretic.   "
204483|NCT00525278|"     To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of     Seasonal Allergic Rhinitis   "
204484|NCT00525291|"     The efficacy of biofeedback and/or low frequency electrical stimulation for the treatment of     anal incontinence has not been proven. First, large well-designed clinical trials are     missing. Second, only few patients reach therapeutically relevant intensities with low     frequency stimulation. In this study, a novel therapeutic concept, termed triple target     treatment (3T) was evaluated. 3T combines stimulation with amplitude modulated middle     frequency (AM-MF), electromyography (EMG)-triggered stimulation and EMG-biofeedback. 3T was     compared with EMG-biofeedback alone after a nine month treatment period.      Methods In this parallel-group randomised multicenter study with blinded observer we enrolled     158 patients with anal incontinence. Primary endpoints were changes from baseline to nine     months in the Cleveland Clinic Score (CCS) and the St. Mark's score (Vaizey score).   "
204485|NCT00525304|"     This study will develop and evaluate the effectiveness of a self-management program for     adults living with both schizophrenia and a co-occurring medical condition.   "
204497|NCT00530114|"     The primary objectives of this study are the following:        1. To demonstrate that AMG 223 will produce a statistically significant reduction in serum          phosphorus compared with placebo over a 3 week treatment period in subjects with CKD          receiving dialysis        2. To describe a dose response for AMG 223        3. To evaluate the safety and tolerability of AMG 223   "
204516|NCT00530361|"     The purpose of this study is to assess whether nesiritide compared to placebo when given with     standard of care therapies, helps preserve kidney function in heart failure (HF) patients     undergoing heart bypass graft surgery that requires the use of a cardiopulmonary bypass     machine (CPB pump or heart-lung machine).   "
215623|NCT00672074|"     The purpose of this study is to determine if ipamorelin is safe and effective in the     management of post-operative ileus.   "
204486|NCT00529971|"     This study will examine the effectiveness of Mindfulness-Based Stress Reduction (MBSR) in     helping men living with HIV cope with negative emotions and stresses in their life. MBSR is     an approach to reducing stress for patients with chronic medical conditions. It involves     systematic training in mindfulness meditation practices to increase quality of life and to     reduce general stress, anxiety, depression or pain. The effectiveness of MBSR will be     evaluated by looking at changes in participants' experience of stress, anxiety associated     with pain management and psychosocial functioning before and after they receive the MBSR     compared with participants who do not receive the MBSR treatment.      In order to participate, individuals must be: male, living with HIV, age 18-70 years, live     within one hour of participating centre, and have a good understanding of the English     language. Questionnaires will be completed before individuals begin the program, at the end     of the intensive phase (8 weeks) and at 6 months after the start of the group program. The     primary program evaluation outcome will be a reduction in stress; secondary evaluation     outcomes will include the improvements in the physical and emotional experience of pain as     well as general psychosocial functioning and self-esteem.   "
204487|NCT00529984|"     STUDY OBJECTIVES        1. The primary objective of this protocol is to determine the safety of immunization with          CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies.        2. The secondary objectives are to evaluate CEA-specific immune response to the          immunizations and obtain preliminary data on response rate.   "
204488|NCT00529997|"     The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and     effective as the control therapy of fusion in patients receiving decompression surgery for     the treatment of clinically symptomatic spinal stenosis at one contiguous vertebral levels     from L1-S1. Safety and effectiveness will be assessed by means of primary study endpoints     which address improvements in pain and function in the absence of major device related     complications.      The study hypothesis criteria for demonstrating safety and efficacy requires scientific     evidence that patients classified as satisfying the primary study endpoint post device     implantation is at least as good for Stabilimax NZ® recipients as that for patients     undergoing fusion with posterior pedicle screw instrumentation at the 24 month followup     assessment.   "
204489|NCT00530010|"     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near     a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be     effective treatment for liver cancer that cannot be removed by surgery.      PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating     patients with liver cancer that cannot be removed by surgery.   "
204490|NCT00530023|"     Feasibility study to compare the effectiveness of the Paradigm Sensor Augmented System versus     subjects continuing to administer insulin in multiple dose injections. Evaluate the     educational materials and time required for training subjects naïve to continuous     subcutaneous insulin infusion (CSII) to use the Paradigm 722 REAL Time System in preparation     for a large multi-center clinical trial   "
204491|NCT00530036|"     Urinary incontinence (UI) is a frequent problem in community-dwelling older adults and has a     huge burden on health complications and healthcare costs. Although effective treatments     exist, UI is frequently neglected resulting in unmet needs for continence treatment and     potential negative health outcomes. The impact of UI in older patients receiving home care     services has not been extensively explored. In a recent study we observed that UI was     identified in 46% of 699 patients followed by the Fondation des Services d'Aide et de Soins     à Domicile in Geneva but the impact of UI on outcome such as institutionalization,     hospitalization or death is unknown.   "
204492|NCT00530049|"     RATIONALE: Developing a questionnaire that patients can use to assess their quality of life     related to the appearance of their face after surgery may help doctors plan the best     treatment for patients undergoing surgery and reconstruction for head and neck cancer in the     future.      PURPOSE: This clinical trial is developing a questionnaire for assessing quality of life     related to facial appearance in patients who have undergone or are planning to undergo     surgery and reconstruction for head and neck cancer; and after dermatologic surgery for     patients with cutaneous skin cancers.   "
204493|NCT00530062|"     This is a research study designed to compare the single-dose effectiveness of     albuterol-HFA-BAI (breath activated inhaler) and albuterol-HFA-MDI (metered dose inhaler) in     asthmatics with poor inhaler coordinating abilities. Patients must be 7 to 70 years of age to     participate in this study.   "
204494|NCT00530075|"     Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and     necrotizing inflammation predominantly affecting the respiratory tract and the kidneys.     Conventional therapy of Wegener's granulomatosis with cyclophosphamide and corticosteroids is     limited by incomplete remissions and a high relapse rate. Patients accumulate irreversible     damage due to the disease and the consequences of prolonged drug exposure. The efficacy and     safety of an alternative immunosuppressive drug, gusperimus, was evaluated in patients with     refractory disease. A prospective, international, nulti-centre, single limb, open label     study. Entry required active Wegener's granulomatosis with a Birmingham Vasculitis Activity     Score (BVAS) >=4 and previous therapy with cyclophosphamide or methotrexate.     Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to     clinical status. Gusperimus, 0.5mg/kg/day, was self-administered by subcutaneous injection in     six treatment cycles of 21 days with a seven day washout between cycles. Cycles were stopped     early for white blood count < 4,000/mm3. The primary endpoint was complete remission (BVAS=0     for at least 2 months) or partial remission (BVAS<50% of entry score). After the sixth cycle     azathioprine was commenced and follow-up continued for a further six months.   "
204495|NCT00530088|"     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a     certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy     using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the     mouth and throat.      PURPOSE: This phase I trial is studying how well photodynamic therapy using porfimer sodium     works in treating patients with recurrent mouth or throat dysplasia, recurrent in situ cancer     of the mouth or throat, or stage I cancer of the mouth or throat.   "
204496|NCT00530101|"     The purpose of this research study is to evaluate MR imaging in subjects receiving     doxorubicin chemotherapy to see if MR can detect heart damage as well as or better than MUGA     scans.      This research study is expected to enroll approximately 10 subjects over 12 months at the     University of Miami / Miller School of Medicine.   "
204498|NCT00530127|"     The primary objective of this study is to demonstrate the safety and tolerability of     deferiprone in subjects with Friedreich's ataxia (FRDA).      The secondary objective is to evaluate the efficacy of deferiprone for the treatment of FRDA,     as assessed by a 9-Hole Peg Test (9HPT), Timed 25-Foot Walk (T25FW), Low-Contrast Letter     Acuity test (LCLA), International Cooperative Ataxia Rating Scale (ICARS), and Friedreich's     Ataxia Rating Scale (FARS).      The tertiary objectives are to evaluate the effect of deferiprone on:        1. cardiac function as measured by changes in Left Ventricular Shortening Fraction (LVSF),          Left Ventricular Ejection Fraction (LVEF) and Left Ventricular (LV) mass using          echocardiogram (ECHO),        2. quality of life using quality-of-life surveys, and        3. functional status using Activities of Daily Living (ADL).   "
204499|NCT00530140|"     Poor prognosis follicular lymphoma patients have an estimated median overall survival of 5-6     years. The proposed trial offers life-time idiotypic vaccination to all such patients in     first relapse/progression who will achieve second (first, in the case of patients who have     never achieved complete response following standard first-line treatment) complete response     through autologous stem cell transplant prior to vaccination start. The ultimate goal is a     cure, defined as a vaccine-maintained complete response lasting both at least 10 years and at     least twice as long as each patient's first complete response.   "
204500|NCT00530153|"     The purpose of this study is to evaluate the effects of an intervention programme on dietary     intake and dental health of 8th grade students.   "
204501|NCT00530166|"     The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the     percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks     of therapy in patients with persistent asthma.   "
204502|NCT00530179|"     The purpose of this study is to evaluate:        1. whether an imaging test called a PET (Positron emission tomography) scan performed after          two cycles of standard chemotherapy is able to identify patients who have a high cure          rate after completing standard chemotherapy alone; and        2. whether high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT)          when used in combination with an antibody called Rituximab results in high cure rates          for those patients predicted to do poorly with standard chemotherapy by the PET scan.   "
204503|NCT00530192|"     This is an open-label, multicenter pilot study in patients with advanced solid tumors.      The primary objective of this study is to compare progression-free survival using a treatment     regimen selected by molecular profiling with progression-free survival for the most recent     regimen the patient has progressed on.      To be eligible, patients must have received at least two lines of prior chemotherapeutic,     hormonal or biological regimens for advanced disease, have measurable or evaluable,     refractory disease and have clear documentation of the time between treatment start and     documented progression on the last treatment prior to study entry. Eligible patients must     undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH     and/or DNA microarray analysis.   "
204504|NCT00530205|"     RATIONALE: Learning about the effects of radiation therapy on the body's muscles, organs, and     bones in patients with stage III non-small cell lung cancer may help doctors plan the best     treatment.      PURPOSE: This clinical trial is studying the effects of radiation therapy on the body in     patients with stage III non-small cell lung cancer.   "
204505|NCT00530218|"     RATIONALE: Antiviral drugs, such as ganciclovir, act against viruses. Giving ganciclovir by     infusion and then by mouth may be effective treatment for cytomegalovirus that has become     active after donor bone marrow transplant.      PURPOSE: This phase II trial is studying how well giving ganciclovir by infusion and by mouth     works in treating patients with cytomegalovirus after donor bone marrow transplant.   "
204506|NCT00530231|"     The purpose of this study is to determine the missing rate of capsule endoscopy using     back-to-back capsule endoscopy.   "
204507|NCT00530244|"     The hypothesis of this study is that feeding infants diagnosed with CF via newborn screening     a formula enhanced with a specific fish-oil fatty acid known as DHA will improve growth and     decrease pancreatic dysfunction (as measured by human fecal elastase-1 in stool) over the     first year of life.      Briefly, infants diagnosed with CF in the first month of life whose parents chose not to     breast feed their babies will be invited to enroll in a study comparing a standard commercial     infant formula (Enfamil) with a formula enriched with arachidonic acid (AA) and     docosahexaenoic acid (DHA). The study formula has 3 times the amount of DHA available in     commercially available formulas. Infants will have monthly tests of stool elastase and blood     work at entry, 3, 6, 9 and 12 months of age.   "
204508|NCT00530257|"     This study investigates whether OROS-methylphenidate improves performance on different     aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder     (ADHD).   "
204509|NCT00530270|"     People with sickle cell disease (SCD) may develop acute chest syndrome (ACS), which is a     common and serious lung condition that usually requires hospitalization. Dexamethasone is a     medication that may decrease hospitalization time for people with ACS, but it may also bring     about new sickle cell pain. This study will evaluate the effectiveness of a dexamethasone     regimen that includes a gradual dose reduction at decreasing hospitalization and recovery     time in people with SCD and ACS.   "
204510|NCT00530283|"     Patients with squamous cell cancer of neck nodes but unknown primary will have a PET-CT scan     prior to biopsies. The utility of PET-CT will be determined in this subset of patients.   "
204511|NCT00530296|"     The purpose of this study is to determine whether Cognitive Behavioral Therapy is effective     in the treatment of depression in patients with end-stage renal disease in hemodialysis     therapy   "
204512|NCT00530309|"     A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of     GSK716155 in Japanese subjects with type 2 diabetes mellitus   "
204513|NCT00530322|"     To ascertain whether there are fewer adhesions (internal scars) formed following laparoscopic     (key-hole) surgery for colorectal diseases than traditional open surgery.   "
204514|NCT00530335|"     The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120     mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental     Disorders, Fourth Edition (DSM-IV) criteria for ADHD   "
205108|NCT00526227|"     The purpose of the Secura clinical study is to evaluate the overall system safety and     clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)   "
204518|NCT00530387|"     It is known that people can develop an allergic skin reaction to a substance which is placed     on the skin and then subjected to sunlight. This process is called Photocontact allergic     dermatitis. It is known that people can develop Photocontact allergic dermatitis to sunscreen     chemicals (filters) and also cream forms of pain-killing drugs called nonsteroidal     anti-inflammatory drugs (NSAIDs).      The purpose of this study is to determine the frequency of Photocontact allergic dermatitis     to 19 sunscreen filters and 5 topical NSAIDs in 1,000 European patients who present to a     dermatologist with a sun-exposed site dermatitis.      Each participant will have the 24 test agents plus one control of petrolatum applied to the     skin of the back for 24 or 48 hours. After removal of the substances, the area of skin will     be exposed to a precise amount of ultraviolet-A light. The area is then assessed 24, 48 and     72 hours later to see if a photocontact allergic reaction has occured. This method is known     as photopatch testing.      The study will run for one year, during which time it is planned to recruit 1,000 patients.   "
204519|NCT00530400|"     The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime     is effective in preventing surgical site infection in patients undergoing surgery for     herniated disk   "
204520|NCT00530413|"     The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the     treatment of catamenial epilepsy.      We propose that since the catamenial seizures are associated with the reduction in levels of     GABA-enhancing allopregnanolone, short-term replacement with the GABAR-enhancing agent     Phenobarbital will reduce the incidence of catamenial seizures.   "
204521|NCT00530426|"     The purpose of this registry is to compile a large clinical database on the medical     management of patients hospitalized with acute heart failure, using information collected     from acute care hospitals across the United States.   "
204522|NCT00530439|"     Obesity is a serious and increasing health problem in the Western World with about one third     of all pregnant women in Denmark being overweight. Among these are more than 11% severe     obese.      Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and     mortality. Observational studies indicate that the rate of pregnancy complications among     obese pregnant women can be limited if weight gain during pregnancy is restricted.      Aims of the trial is to study the effects of diet and physical training during pregnancy     among Danish obese women. Also to describe the metabolic effects of lifestyle intervention     during pregnancy.      360 obese pregnant women with Body Mass Index (BMI) > 30 are randomized to lifestyle     intervention group or control group. The intervention is composed of individual dietician     counselling and physical training. The physical training includes weekly aerobic exercises in     a fitness center and lifestyle coaching in small groups.      Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus,     blood pressure, and metabolic markers. All women receive vitamin supplementation to assure     sufficient intake.   "
204523|NCT00530452|"     The primary objective of this study is to evaluate the safety and efficacy of 3 loading and     maintenance dose levels of CG100649 administered for 21 days in the treatment of     osteoarthritis pain.   "
204524|NCT00530478|"     The purpose of this study is to demonstrate the efficacy and safety of donepezil on the     recovery of cognitive function in patients with stroke and to delineate the neurophysiologic     mechanisms of the therapeutic effect of donepezil on the recovery of cognitive network using     functional neuroimaging technique.   "
204525|NCT00530491|"     A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative,     early removal of chest tubes) is evaluated compared to conventional perioperative treatment     (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 <     70% of expected value or < 1.5L who undergo resections of the lung.   "
204526|NCT00530504|"     The purposes of this study are:        1. To provide additional safety and effectiveness information on the commercial use of          Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection          Device.        2. To evaluate rare and unanticipated adverse events.        3. To evaluate the physician level of experience with carotid artery stenting procedures          with adverse event rates.   "
204527|NCT00530517|"     Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled     with 6mg Sumatriptan to be used by patients to treat acute migraine treatment. Study     participation will last one month and include 2 doctor visits and 2-4 phone calls.   "
204528|NCT00530530|"     To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with     restless legs syndrome   "
204529|NCT00530543|"     The purpose of this study is to investigate the effects of robot-assisted gait training on     active walking in the patients with stroke.   "
204530|NCT00530556|"     To assess the efficacy and safety of zolpidem at doses up to 10 mg compared to placebo in     patients with insomnia associated with osteoarthritis   "
204531|NCT00530569|"     About 30% of breast cancers have higher than normal levels of a cellular marker called HER2.     The amount of HER2 is often measured in breast tissue. A higher level of this marker usually     indicates a more aggressive type of breast cancer. Cytokeratin is a second cellular marker     found in breast cancer cells. Detection of Circulating cytokeratin in the blood could     indicate the presence of cancer. The Pathology Department of the Tom Baker Cancer Center is     doing this study to see if measuring the levels of circulating HER2 and cytokeratin, through     blood testing has clinical significance for patients with breast cancer.   "
204532|NCT00530582|"     Sleep is impaired in postmenopausal women (difficulty falling asleep, frequent awakenings).     Progesterone prompted benzodiazepine-like effects on sleep EEG in young normal male subjects.      Aim of this study was to test if replacement therapy with progesterone improves sleep after     menopause.      Design, Setting, and Participants: A double blind cross-over design study with 2 treatment     intervals of 21 days duration separated by a 2 weeks washout was performed. A oral dose of     300mg micronized progesterone was given each for 21 days. At the beginning and the end of the     two intervals a sleep EEG was recorded and cognitive performance was assessed in 10 healthy     postmenopausal women (age: 54-70 yrs).   "
204533|NCT00530595|"     Cardiovascular disease is a leading cause of mortality in patients on hemodialysis therapy     (HD), accounting for 30 to 50% of all death. Although angiotensin receptor blockers (ARBs)     are effective for patients with diabetes and chronic kidney disease in reducing or preventing     cardiovascular diseases, there has been no decisive study that demonstrated treatment with     ARBs is effective in patients on HD.   "
204536|NCT00530634|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) together with radiation     therapy after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well surgery followed by gemcitabine, cisplatin,     and radiation therapy works in treating patients with stage II or stage III non-small cell     lung cancer.   "
204537|NCT00530647|"     The purposes of this study are to investigate the functional connectivity of motor network in     patients of stroke and investigate the mechanism of brain plasticity for recovery after     stroke.   "
204538|NCT00530660|"     The purpose of this Phase II follow-up study (to study 810501) is to assess the     immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza     vaccine administered 12 to 17 months after a two-dose regimen of different doses of an     adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A     data safety monitoring board will review the safety data after the booster vaccination. The     H5N1 influenza antibody persistence 180 days after the booster vaccination will also be     assessed.   "
204539|NCT00530686|"     The purpose of this study is to assess a novel approach to immunosuppression in allogenic     pancreatic islet cell transplant recipients. In addition, the study aims to assess remote     site islet processing with culture for pancreatic islet cell transplantation in human     subjects.   "
204540|NCT00530699|"     The purpose of this study is to assess safety and tolerability of multiple ascending doses of     AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with     relapsed acute myeloid leukaemia who are not considered to be suitable for standard     chemotherapy.   "
204541|NCT00530712|"     This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting     using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of     atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.   "
204542|NCT00530725|"     Collapsed lungs are common injuries after traumatic injury that regularly cause needless     deaths despite being treatable with chest tubes. Properly used these tubes can be     life-saving. Unfortunately, improperly used they can cause pain, bleeding, and other fatal     complications themselves. Over the last few decades with increased use of CT scanning it is     apparent that many small collapsed lungs are not seen on chest X-rays, and there is little     guidance for the treating Doctors as to how to treat these patients. There is almost no good     data that tells us whether these smaller pneumothoraces require treatment with chest tubes or     whether they can simply be closely watched. This proposal is to carry out a simple trial of     randomly assigning patients who do not appear to have any symptoms or problems from their     occult pneumothorax to either having a standard chest tube or to being watched. Our careful     review of the medical literature indicates that the investigators cannot honestly tell     patients and their families which treatment is best or required. Our audit of current     practice also indicates that Doctors in Calgary and across Canada, regularly prescribe both     treatments regularly but in a hap-hazard. The patients in this study will be very closely     watched in the intensive care unit and if they develop any breathing problems and do not have     a chest tube in, then one will be inserted. The main results that the investigators are     trying to determine with this pilot study, though, is whether the investigators are able to     detect appropriate patients, to recruit them into such a study, and whether the guidelines     the investigators have created to manage these patients in this study will be acceptable to     all the patient's care givers. This data will help us to design a future large multi-centre     trial that will hopefully provide information as how best to manage this type of injured     patient.   "
204543|NCT00530738|"     It is the purpose of this trial to provide evidence for safety and efficacy of long term home     parenteral nutrition with either Lipofundin MCT or Lipoplus in patients with proven     insufficient enteral resorption.   "
204544|NCT00530751|"     RATIONALE: Learning about the concerns that individuals may have about providing family     medical history online for genetic risk assessment or research may help doctors plan future     research.      PURPOSE: This clinical trial is studying views on sharing family medical history in healthy     women undergoing mammograms or breast evaluation.   "
204545|NCT00530764|"     The purpose of this study is to determine the effective dose range and to demonstrate a     non-effective dose range of Sativex in patients with advanced cancer, who experience     inadequate pain relief even though they are on optimized chronic opioid therapy.   "
204546|NCT00530777|"     In this study, we will determine whether treating pregnant and breastfeeding women     co-infected with human immunodeficiency virus type 1 (HIV-1) and herpes simplex virus type 2     (HSV-2) with daily valacyclovir will reduce HIV-1 levels in plasma, genital, and breast milk     and will decrease the risk of mother-to-child HIV-1 transmission.   "
204547|NCT00530790|"     This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in     Restless Legs Syndrome patients.   "
204548|NCT00530803|"     The objective of this study is to compare the efficacy of the Synera patch applied for 20     minutes with the efficacy of EMLA Cream applied for 60 minutes in reducing pain associated     with venipunctures in children.   "
204549|NCT00530816|"     To evaluate the best overall response rate, safety and tolerability of carfilzomib in     patients with relapsed or refractory multiple myeloma.   "
204550|NCT00530829|"     Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as     treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent     future episodes. The use of zinc at home to treat diarrhea in an African setting, where     malaria, HIV and malnutrition are common, has not been well-studied.      Objective. To evaluate if zinc treatment for diarrhea given at home in Kenyan children will     decrease the community prevalence of diarrhea more than zinc given only in the clinic Work     planned. We propose to do a community-randomized intervention study of 10 days of dispersible     zinc tablets given in the home, in addition to ORS, to treat diarrhea in children under-5     years of age living in a rural part of Bondo District. The comparison group will be children     who receive zinc and ORS in the clinic only. The primary outcome will be a comparison of the     prevalence of diarrhea in home zinc versus nonhome zinc villages. Secondary outcomes will be     the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the     prevalence of acute respiratory infection, and the effect of malaria infection on treatment     with zinc. Thirty-three villages (approximately 1300 children) will be enrolled and children     will be followed for 1 year.      Significance of results. If this study shows zinc given at home to be effective, this might     be considered by the Kenyan MOH as an essential component of the treatment of diarrhea in     children at the community level.   "
204778|NCT00521872|"     This study compares pre- and postoperative (at 6 month) quality of life and pathomorphology     of the pelvis (by MRI defecation) after a STARR procedure for outlet obstruction.        -  Trial with surgical intervention   "
204551|NCT00530842|"     The primary objective of this study is to demonstrate that treatment with a free combination     of tiotropium and salmeterol provides superior improvement in static lung volumes and     exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients     with COPD.      The secondary objective includes assessment of safety.   "
204552|NCT00530855|"     This open-label extension trial will assess the long-term use of Lacosamide monotherapy and     safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset     seizures who were previously enrolled in the conversion to monotherapy trial (SP902).   "
204553|NCT00530868|"     This purpose of this trial is to show that the combination of Avastin and hormone therapy     should be more effective than hormone therapy alone for the treatment of breast cancer.   "
204554|NCT00530881|"     This will be a 4-week, multicenter, randomized, double-blind, parallel group,     placebo-controlled, safety, tolerability, and efficacy study. Patients will be screened and     be on one of three doses of PHX1149 (a new drug candidate for the treatment of Type 2     diabetes ) or placebo. The drug is a DPP4 inhibitor   "
204555|NCT00530894|"     The purpose of this study is to determine the safety and effectiveness of the device and     delivery systems (transfemoral and transapical) in high risk, symptomatic patients with     severe aortic stenosis.   "
204556|NCT00530907|"     The goal of this clinical research study is to find the highest tolerable dose of bevacizumab     in combination with valproic acid that can be given to patients with advanced cancer that has     not responded to standard treatment or where there is no standard treatment for the disease.     The safety of this drug combination will also be studied.   "
204557|NCT00530920|"     The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV)     and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be     used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy     and safety   "
204558|NCT00530933|"     The purpose of this study is to determine whether tibial nerve stimulation is an effective     treatment for faecal incontinence.   "
204559|NCT00530946|"     To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in     Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period   "
204560|NCT00530972|"     To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in     patients who have relapsed or not responded to a previous suboptimal therapy based in     Interferon.   "
204561|NCT00530985|"     To test the hypothesis that veterans counseled around managing their benefits will work more     and have a better quality of life than those receiving non-specific counseling.   "
204562|NCT00530998|"     This is an observational study of pain and outcomes from females undergoing transvaginal     NOTES removal of their appendix or gallbladder. Female subjects who elect to have a     transvaginal NOTES removal of their appendix or gallbladder and agree to be in this study     (through signature on the informed consent form) will be followed per standard of care, with     additional follow-up for data collection including the following:        -  Subjects will complete a 7 day pain/temperature log after surgery        -  Subjects will complete a standardized sexual function questionnaire (Female Sexual          Function Index) prior to surgery and 6 months after surgery        -  Subjects will receive a phone call at 6 months and at 1 year after surgery to capture          data related to safety, adverse events, hospitalizations and patient satisfaction      Additional data related to pain and outcomes will be collected at baseline/screening and at     follow-up as necessary.   "
204563|NCT00531011|"     The purpose of this two part study is the assessment of the performance of the XIENCE V®     Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific     setting of patients with Multi-Vessel Coronary Artery Disease (MVD).   "
204564|NCT00531024|"     Choroidal neovascularisation (CNV) in age-related macular degeneration is one of the major     causes of blindness in the western world. It is already known that the vascular endothelial     growth factor (VEGF) plays a major role in the development of CNV. Photodynamic therapy     (PDT), subretinal surgery, and intravitreal injection of VEGF- inhibitors are the common     treatments. These methods are either very invasive or need to be repeated several times over     long periods of time in order show some effect. Furthermore PDT can only be performed in eyes     with pigment epithelium detachments (PED) of maximum 50% of the avascular zone, while     intravitreal injections can lead to endophthalmitis and acute glaucoma. A systemic treatment,     which would only need to be administered 3 times within 6 weeks would be a major effort in     macular degeneration therapy.   "
204565|NCT00531037|"     Recent studies have shown the importance of preserving spontaneous atrio-ventricular     conduction in patients implanted with an implantable cardiac pacemaker.      The SafeR/AAISafeR pacing mode, developed by Sorin Group/ELA Medical and available on Reply     and SymphonyTM dual-chamber pacemakers, provides physiological atrial pacing while ensuring     ventricular backup pacing in case of AV block in patients implanted for Sinus Dysfunction,     Brady Tachy Syndrome or paroxysmal Atrio Ventricular block3 (AV block).      Memory functions (EGM episodes and Marker chains) available with the SafeR/AAISafeR pacing     mode have been used until now to verify the safety of the algorithm. However, these stored     EGM episodes and Marker chains may also provide precious information related to the nature of     the AV block and the evolution of conduction disorders through time.      So far no studies have been carried out on this subject using the latest generation of     pacemakers. This results from the unavailability of any diagnostic tool in currently marketed     devices. Studies reporting the incidence of AV block in patients implanted for Sinus     Dysfunction are based only on the occurrence of symptomatic AV block and/or the observation     of conduction disorders on surface ECG during follow-up4,5.      The diagnostic functions available with the SafeR/AAISafeR mode enable to diagnose and record     in device memory all AV blocks, regardless of the degree of the AV block and the symptom(s)     of the patient. Therefore, this unique diagnostic tool could enable to determine the nature     and to analyze through time the evolution of conduction disorders in patients implanted for     Sinus Dysfunction, Brady Tachy Syndrome or paroxysmal Atrio Ventricular block, in order to     better identify the indications for implant and to provide further appropriate pacing mode.      The observational study will enable to compile all these device memory data in order to     directly assess statistical analysis of AV block incidence and evolution according to the     nature of the AV block, the incidence of paroxysmal atrial arrhythmias, the anti arrhythmic     drugs medication and other.   "
204566|NCT00531050|"     This study investigated the effect of exercise and high-dose salbutamol on the maximum heart     rate in patients with chronic obstructive pulmonary disease (COPD) receiving therapeutic     doses of indacaterol, salmeterol and placebo.   "
204567|NCT00531063|"     This extension study is designed to provide long-term safety and efficacy data beyond 12     months up to Month 36.   "
204599|NCT00531492|"     The purpose of this study is to examine the efficacy of Technique Kangourou (TK) between low     birth weight (LBW) infants and their mothers started as soon as possible within 24 hours     after birth in developing country.      For the purpose of this study, TK is defined as skin-to-skin direct and continuous (24 hours)     contact between LBW infants and their mothers or any other people who substitute mothers.   "
204568|NCT00531076|"     In spite of the use of radiation combined with conventional chemotherapy, the long-term     survival prognosis for most patients with locally advanced non-small cell lung cancer is     disappointing. Much effort is currently focussed on exploring new molecular targeted agents     that may improve upon survival. The addition of an agent that targets blood vessel formation     in tumors, bevacizumab or Avastin, to conventional chemotherapy has been shown to improve     survival in metastatic non-small cell lung cancer. Data from animal studies have shown that     bevacizumab and related agents also increase tumor cure rates when administered both during     and after radiotherapy. This suggests that combined bevacizumab and chemo-radiation may     improve survival in local-advanced disease as well. Before such clinical studies can     commence, the safety and normal tissue toxicity profile of bevacizumab with thoracic     radiotherapy must first be established. In this study, escalating doses of bevacizumab will     be administered during radiotherapy, followed by maintenance bevacizumab.   "
204569|NCT00531089|"     The general objective of this study is to assess the efficacy and safety of Rituximab in the     management of patients with refractory or relapsed thrombotic thrombocytopenic     purpura-hemolytic uremic syndrome (TTP-HUS). There have been several case reports and case     series describing the use of Rituximab in patients with TTP-HUS; however its use has not been     studied in a large trial. It is hypothesized that Rituximab may ameliorate the severity of     certain cases of TTP-HUS by decreasing the number of activity of B-cells which may result in     decreased production of the ADAMTS13 protease inhibitor. Patients with TTP-HUS not responding     to standard therapy or patients with relapsed disease may have particular benefit. Treatments     that decrease the frequency of relapse or shorten the time to remission of TTP-HUS will be of     benefit by decreasing the need for blood product support.   "
204570|NCT00531102|"     Currently, newborns receive 100% supplemental oxygen by free flow when they remain cyanotic     despite demonstrating regular respiratory effort. Resuscitating infants with continuous     positive airway pressure (CPAP) in room air may improve oxygen saturations more quickly than     providing FFO2 because of its ability to establish functional residual capacity in the lungs.     Our primary hypothesis is that in this blinded, randomized control trial, more infants (≥35     weeks gestation) resuscitated with CPAP in room air will have an oxygen saturation ≥80% at     five minutes of age compared to infants resuscitated with the 50% FFO2.   "
204571|NCT00531115|"     The purpose of this study is to determine confirmed objective response rate to combination     therapy with cetuximab plus XELOX for 4 cycles followed by maintenance treatment with     cetuximab plus capecitabine as first line treatment in elderly patients with metastatic     colorectal cancer   "
204572|NCT00531128|"     This study will determine if dietary supplements of sitosterol (a plant cholesterol commonly     found in vegetables) can modify blood sugar and cholesterol levels and reduce the stiffness     of the blood vessels in people with an abnormal copy of a gene that causes sitosterolemia.     People who carry only one copy of the abnormal gene are healthy but have increased blood     levels of sitosterol. People with two abnormal copies of the gene have increased levels of     sitosterol and have an increased risk of heart attack. This condition is called     sitosterolemia. Although extremely rare in the general population, up to 4% of the Amish     carry an abnormal copy of this gene.      People of Amish background who are 18 years of age or older and in whom one person carries     one copy of the abnormal gene that causes sitosterolemia and the other does not have an     abnormal gene may be eligible for this study. Subjects must be of the same sex and within 5     years of age of each other.      During two periods of one month each participants receive pills containing sitosterol and     then a special diet and meal supplements to change the levels of sitosterol in the diet.     During only one of the two study periods, subjects receive sitosterol supplements in the     pills for one month and then for 10 days in the diet. At the end of each study period,     subjects come to the NIH Clinical Center for one day for the following tests:        -  Measurements of height, weight, blood pressure and heart rate.        -  Adipose (fat) tissue biopsy. A small piece of fat from under the skin of the abdomen is          removed to examine how sitosterol affects fat tissue and its ability to process sugar          and fat.        -  Indirect calorimetry. A plastic transparent hood is placed over the subject s head to          collect the air that is breathed for about one-half hour to study how the body uses          sugar to generate energy.        -  Endothelial vascular function. An ultrasound picture of a blood vessel in the forearm is          taken and a blood pressure cuff is inflated around the arm to measure the vessel s          ability to stretch.        -  Intravenous glucose tolerance test: A small plastic tube is placed in a vein in each          arm. Then over one minute the subject receives glucose through one of the tubes. Twenty          minutes later the subject is given a small amount of insulin through the same tube.          Blood samples are drawn through the tube in the other arm at frequent intervals for 3          hours. This test measures how sitosterol affects how the body processes sugar.        -  DEXA scan. The subject lies on an x-ray table for 20 minutes during the scan, which          measures total body fat.   "
204573|NCT00531141|"     The Optical Coherence Tomography (OCT) is a non-contact, non invasive method to examine the     retina by providing cross-sectional scans through the retina. Measurements of the retinal     thickness based on automatically set border lines created by threshold algorithm provide     information concerning the amount of intraretinal fluid and activity of the lesion. In this     study the reproducibility of retinal thickness measurements in patients suffering from     age-related macular degeneration performed by two independent examiners of two examinations     of the same day but performed in a time interval of at least two hours should be evaluated.     Using the macular thickness program of stratus OCT, 6 radial lines through the center of the     foveal avascular zone are performed, Differences between the first and second measurement     will be investigated by a 95% confidence interval, a Bland-Altman plot (with corresponding     regression analysis) and a random effect model with time, examiner and diagnosis as fixed     factors. Although threshold algorithm failures and fixation problems are common in     age-related macular degeneration evidence of reproducibility and repeatability of maximum     retinal thickness is expected.   "
204574|NCT00531154|"     The aim of this study is to investigate whether there was an association between obesity and     periodontitis, tendency to caries and periapical lesions.      People who have a higher body mass index produce cytokines (hormone-like proteins), that lead     to systemic/chronic inflammation (like periodontitis and periapical lesions), and obesity     related dietary habits could result in an increment of dental caries because both the amount     and the frequency of sucrose ingestion are important factors associated with the aetiology of     the oral disease.   "
204575|NCT00531167|"     Antiviral resistance mutations limit the efficacy of therapy for chronic hepatitis B. At year     2, resistance to adefovir may occur as high as 25% in patients with history of lamivudine     resistance. Resistance to entecavir is reported to be 10% in lamivudine refractory patients     during the same period. However, combination of lamivudine and adefovir decreased the     adefovir resistance rate as low as 0% in the recent studies. By overcoming the antiviral     resistance, the efficacy of therapy will be maximized. This study is intended to compare the     efficacy of two strategies, combination of lamivudine and adefovir vs. entecavir monotherapy     in patients with lamivudine resistance.   "
204677|NCT00520533|"     This clinical trial explores the safety, efficacy, and effects on functional imaging of the     combination of cG250 monoclonal antibody administered intravenously weekly in combination     with daily oral sunitinib, in patients with advanced renal cell carcinoma.   "
204576|NCT00531180|"     Objectives:      Primary Objective:      1. To determine the correlation between 4-dimensional computed tomography (4D CT) derived     ventilation and single photon emission tomography (SPECT) aerosol Tc-99m determined     ventilation.      Secondary Objective:        1. To evaluate the reproducibility of the 4D CT derived ventilation and to obtain an          estimate of the variance in a single setting.        2. To assess the correlation between hypoperfused and hypoventilated pulmonary regions in          patients with thoracic malignancies.        3. To investigate the effect of continuous positive airway pressure (CPAP) on ventilation          and tumor motion.   "
204577|NCT00531193|"     To establish the extent to which BIIB014, following 8 to 12 consecutive days of dosing at     selected dose levels, occupies the brain's A2A receptors. Receptor occupancy will be assessed     by PET scanning using a radiolabelled tracer.   "
204578|NCT00531206|"     This observational study is supposed to assess (under conditions of clinical practice in     daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose     Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load     below the limit of detection.   "
204579|NCT00531219|"     This is an observational study of pain and outcomes from patients undergoing transgastric     NOTES removal of their appendix or gallbladder. Subjects who elect to have a transgastric     NOTES removal of their appendix or gallbladder and agree to be in this study (through     signature on the informed consent form) will be followed per standard of care, with     additional follow-up for data collection including the following:        -  Subjects will complete a 7 day pain/temperature log after surgery        -  Subjects will receive a phone call at 6 months and at 1 year after surgery to capture          data related to safety, adverse events, hospitalizations and patient satisfaction      Additional data related to pain and outcomes will be collected at baseline/screening and at     follow-up as necessary.   "
204580|NCT00531232|"     There is no well accepted standard care for patients who fail or are intolerant to any of the     currently approved therapies for Myelodysplastic Syndromes (MDS). In this study, patients     will be assigned to receive 25mg of oral clofarabine daily for 5 days. Patients may receive     up to 8 cycles of treatment with clofarabine as long as the patient continues to benefit and     in the absence of progressive disease.   "
204581|NCT00531245|"     Capecitabine and oxaliplatin(XELOX) is active first-line therapy for patients with metastatic     colorectal cancer. Phase II study of TS-1, a novel oral fluoropyrimidine derivative, showed     activity in patients with metastatic colorectal carcinoma. Preclinical data of TS-1 with     oxaliplatin showed synergistic activity in vivo human colorectal cancer xenograft. There is     no data about the optimal dose of TS-1 with 2 weeks schedule combined with oxaliplatin.     Therefore in a phase I study, we would like to determine the maximum tolerated dose(MTD) of     TS-1 and oxaliplatin and define the recommended dose for subsequent phase II study. And then,     in a phase II study we would like to evaluate the efficacy(response rates) and toxicities of     the new combination regimen in advanced colorectal cancer.   "
204582|NCT00531258|"     Depression is very common in people who have experienced a traumatic brain injury. Few     treatments have been found to be effective in treating depression in this situation. We     intend to investigate the effectiveness of a form of brain stimulation, transcranial magnetic     stimulation, which has been found to be effective in treating depression in people who have     not undergone a brain injury. By evaluating new methods of treating depression in this     population, we hope to increase the options available for treating people in this difficult     situation. Furthermore, problems with aspects of thinking are also commonly present post     brain injury, as in some individuals with depression. Various brain stimulation techniques,     including transcranial magnetic stimulation (TMS) have been shown to have a positive effect     on cognition. We also intend to investigate whether a therapeutic effect on cognitive     deficits is present following TMS, in addition to any effects on depression. New treatment     protocols will be developed, and understanding of the pathology and treatment of post     traumatic brain injury depression will be enhanced.   "
204583|NCT00531271|"     To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-008     giver every 3 weeks; to characterize the toxicities of ABI-008; and to determine the     pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule to patients     with metastatic breast cancer.   "
204584|NCT00531284|"     The primary objectives of this Phase 1b/2 study were as follows:        -  Phase 1b (Bolus and Infusion): To evaluate the safety and tolerability of carfilzomib in          patients with relapsed solid tumors and in patients with relapsed and/or refractory          multiple myeloma and in patients with refractory lymphoma.        -  Phase 2 (Bolus): To evaluate the overall response rate (ORR) after 4 cycles of          carfilzomib in patients with relapsed solid tumors.   "
204585|NCT00531297|"     Any efforts to spare patients with T1 carcinomas of the rectum from low anterior resection or     even abdominoperineal resection are linked to the risk of locoregional recurrence of about     10% (range, 0-24). This is tolerated in the view of the morbidity and mortality risk related     to transabdominal resection, which is as high as 7-68% and 0-6.5%, respectively. Accordingly,     in addition to transanal local excision various adjuvant therapy schemes with chemo- and/or     radiotherapy were developed, given the uncertainty about the lymph node stage. Another     approach was to identify histological risk criteria in the primary tumor in terms of defining     the limits of rectum-sparing therapy.      In earlier experimental and clinical studies the investigators researched and applied     dorsoposterior extraperitoneal pelviscopy, i.e. perineal access to the soft-tissue areas of     the minor pelvis using minimally invasive surgery. in T1 carcinoma of the rectum this     technique becomes all the more significant, as the perineal approach makes it possible to     perform an endoscopic posterior mesorectal resection (EPMR) in combination with     rectum-sparing surgery Thereby the relevant lymphatic field of the lower rectum can be     removed and histologically examined. As a consequence EPMR should lower the loco-regional     recurrence rate, since the most common causes of such are pre-existent but so far not     detectable lymph node metastases besides the incomplete resection of the primary tumor.   "
204597|NCT00531466|"     A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following     a spinal cord injury. This study has three purposes:        1. To determine whether AV650 is safe for patients with spinal cord injury;        2. To assess what the body does with AV650 once it is ingested; and,        3. To gather some early evidence as to whether AV650 is effective in treating spasticity in          patients with spinal cord injury.   "
204586|NCT00531310|"     CML, a malignant disorder of stem cells, is characterized by increases in both immature and     mature myeloid, erythroid, and lymphoid cells, as well as platelets in the peripheral blood.     The cytogenetic hallmark of CML is the Philadelphia(Ph)chromosome found in the malignant     cells of 95% of patients. CML comprises 7-20% of all leukemias with an overall incidence in     the general population estimated at 1 to 2 per 100,000. The peak incidence occurs in the     fifth decade, however, all age groups, including children, are affected. The only reported     environmental risk factor is exposure to excessive ionizing radiation that is documented in     only a very small percentage of patients. Clinically, CML is characterized by an initial     chronic phase in which patients may report mild constitutional symptoms; however, 40-50% are     asymptomatic and are diagnosed based upon abnormal blood counts discovered during a routine     examination. The chronic phase typically lasts three to five years, and is followed by an     accelerated phase distinguished by progressive systemic symptoms, an increasing resistance to     conventional chemotherapy, and a rise in the peripheral blood and bone marrow blast count.     This evolves rapidly into a blastic crisis characterized by immature cells resembling the     blasts characteristic of acute leukemia. The presence of 30% or more blastic cells in the     blood or marrow is diagnostic of this final blastic phase which is typically fatal within 3     to 6 months.      The primary treatment options for CML have traditionally been monotherapy with either     busulfan or hydroxyurea. Both agents are able to control the clinical symptoms associated     with CML, as well as induce hematological remissions in 80% of chronic phase patients.     However, complete cytogenetic remissions with either agent are rare, and neither is able to     prevent eventual progression to the terminal blastic phase; therefore, these therapies can     only be considered palliative.      The primary purpose of this clinical research trial is to study the feasibility of a reduced     intensity allogenic transplant for CML. This study will also determine the side effects as     well as the response rate.   "
204587|NCT00531323|"     The purpose of the study is to look at whether changing directly from one medication for HIV     (efavirenz) to a new medication for HIV (TMC125) has any effect on the levels of TMC125 in     the blood, compared to when TMC125 is taken without efavirenz having been taken immediately     beforehand.      The study aims to help the investigators understand whether it is safe to change directly     from efavirenz to TMC125 (with no gap between the treatments) in patients who need these     treatments.      The study will investigate the blood levels of TMC125 when it is taken both once and twice a     day.   "
204588|NCT00531336|"     The first results of Anti-Vascular Endothelial Growth Factor (VEGF) therapy were very     promising and superior to established therapies. Three different substances (all of them     applied intravitreally) are available, but comparative studies have not yet been conducted.     In this pilot study, the safety (number of adverse events) and efficacy (distance acuity     testing retinal thickness measurement) of Avastin and Macugen applied as monotherapy will be     compared to a combined treatment of Avastin followed by Macugen used for retreatment.      At least equal results of the combined therapy are expected.   "
204589|NCT00531349|"     The purpose of this study is to determine whether recurrence of local and metastatic cancer     after open hysterectomy for stage 1 or 2 endometrial cancer is reduced when patients receive     epidural anesthesia/analgesia combined with propofol sedation rather than sevoflurane     anesthesia and opioid analgesia.   "
204590|NCT00531362|"     Aspirin is an essential drug for the treatment of cardiovascular disease. The standard dose     is 75mg per day (much lower than that for inflammation or fever). One of the side-effects of     aspirin is a gastric ulcer which can be fatal. To prevent this it is common to use     enteric-coated aspirin. This passes through the stomach intact and dissolves in the     intestines. This prevents high levels of drug forming in the stomach reducing ulcer     formation. Recently there is evidence of high levels of aspirin resistance, ie, patients who     appear not to achieve the maximum benefit from aspirin. Clinical studies have shown a     significant increase in mortality among these patients.      A recent study that we performed showed that enteric-coated aspirin is not as effective as     plain aspirin. This was especially noticeable in heavier volunteers. In fact it appeared that     enteric-coated aspirin only delivers 50mg aspirin instead of the full 75 mg. For volunteers     resistant to enteric-coated aspirin simply switching them to plain aspirin solved the     problem.      We propose to recruit patients on 75 mg enteric aspirin and test them for evidence of poor     response to aspirin. Poor responders will then be given 75mg plain aspirin and tested for     their response. Those that fail to respond will then receive 150 mg aspirin. If the results     of the healthy volunteer study are replicated this would provide a very cheap and effective     solution to a serious problem.   "
204591|NCT00531375|"     The primary purpose of this study is to investigate the effect of silicone hydrogel contact     lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to     compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.   "
204592|NCT00531401|"     The purpose of this study is to determine whether Salirasib is effective to shrink or prevent     the growth of the tumors associated with non-small cell lung cancer in both patients who are     newly diagnosed or have recurrent disease.   "
204593|NCT00531414|"     The OsmohalerTM is a registered device in Australia. It is used to deliver a dry powder a     commercial preparation of mannitol registered as AridolTM to test if a person has irritable     airways such as active asthma.      The overseas regulatory authorities need to know that people of all ages can achieve an     adequate inspiratory flow through this device during a controlled deep inspiration. Adequate     flow is generally regarded as greater than 30 litres per minute in children and 60 litres per     minute in adults. The OsmohalerTM is a device with low resistance and is already in use in     Australia to deliver mannitol. However there is a need to document inspiratory flows through     the device during a controlled deep inspiration. The protocol requires subjects to perform a     controlled deep inspiration from the device on three or five occasions. No substance will be     inhaled.   "
204594|NCT00531427|"     The objective of this study is to determine the analgesic efficacy and safety of     Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve     subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The     double-blind treatment intervention duration is 12 weeks, during which time supplemental     analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and     acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to     all subjects in addition to study drug.   "
204595|NCT00531440|"     This extension study is designed to provide long-term safety and efficacy data beyond 12     months up to Month 36.   "
204596|NCT00531453|"     The purpose of this Phase 2 randomized study is to evaluate the efficacy and safety of     treatment with a regimen of VELCADE, dexamethasone, and thalidomide (VDT) or VELCADE,     dexamethasone, thalidomide, and cyclophosphamide (VDTC) in subjects with newly diagnosed     symptomatic multiple myeloma who have received no prior treatment and are candidates to     receive high-dose therapy and autologous bone marrow/stem cell transplantation.   "
204600|NCT00531505|"     1. Briefly describe the purpose of this protocol. First purpose of the study is to          understand the inheritance of morbid obesity.        2. Briefly summarize how participants are recruited. Volunteers will first learn of LABS-2a          research opportunity at the Bariatric Surgery Informational meetings.        3. Briefly describe the procedures subjects will undergo.           Participants will be asked to complete a set of memory tests. Fat and Liver samples will          be removed during their weight loss surgery, specifically for this research study.        4. If applicable, briefly describe survey/interview instruments used. Memory tests will be          performed to assess cognition.        5. Briefly describe how the data will be analyzed to address the purpose of the protocol.      The memory test data collected and compared against well established norms. Tissue samples     will stored in a repository to be genetically studied for an indefinite amount of time.     Genetic studies will be related to the disease of obesity and associated comorbidities     brought on by the disease.   "
204601|NCT00531518|"     EDIPP is a multisite trial of early identification and intervention to prevent the onset of     psychosis in adolescents and young adults, carried out at six sites across the United States.     The hypothesis is that very early identification and intervention will be effective in     delaying or preventing onset of psychosis and improving social and occupational functioning.   "
204602|NCT00531531|"     It is well known that an association exists between the acquisition of some respiratory     pathogens and prognosis of CF people. About 57 % of patients has a lung infection due to     P.aeruginosa (PA). Transmission of PA between CF patients is possible and several prevention     measures are recommended. Among these measures, all international guidelines recommend that     CF people maintain a minimum distance of 1 meter between them. However, this recommendation     is not supported by specific studies and scientific evidence. In other words, the     investigators don't know if this measure is sufficient or excessive, as it is based only on a     theoretical rationale.      This study aims at measuring experimentally the distance that can be reached by PA emitted     from airways of colonized CF patients during cough and during conversation.      To this purpose, the investigators will evacuate the presence of PA on surfaces placed at 4     different distances from patients, through the collection of 8 swabs, 4 of which following     cough and 4 following conversation. Swabs will be collected on sterile surfaces comprised     between tra 0 - 0,5 mt; 0,5 -1,00 mt.; 1,00 - 1,5 mt and 1.5-2 mt.      All the PA-positive CF patients of the CF Centre of Tuscany aged 14 or more will be     recruited.   "
204603|NCT00531544|"     A SU011248 expanded access protocol for systemic therapy of patients with metastatic Renal     Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may     derive benefit from treatment with SU011248   "
204604|NCT00531557|"     The purpose of the study is to study the effects of switching from an antiretroviral     combination that includes two ritonavir boosted protease inhibitors to replacement of these     two protease inhibitors with a new protease inhibitor called Darunavir (also boosted with     ritonavir).      The study will investigate the effect of the switch on viral load (the levels of the HIV     virus in the blood), on immunological parameters (CD4 count) and on other safety parameters     and also on quality of life.      In a subgroup of patients the impact of the switch on the body's response to the hormone     insulin will also be measured (Euglycaemic clamp sub group)   "
204605|NCT00531570|"     In the United States, ovarian cancer is the fifth most common cancer to develop in women and     causes more deaths than all other gynecologic malignancies combined. Because of the     difficulties in detecting early stage ovarian cancer, 75% of women continue to be diagnosed     with advanced stage disease (stage III or IV).      The National Ovarian Cancer Early Detection Program (NOCEDP) as part of the National Cancer     Institute's Early Detection Research Network (EDRN) is committed to the development of     effective means for the accurate detection of early stage ovarian cancer.      The last decade has seen rapid technological advances in diagnostic ultrasonography with the     recent development of three-dimensional imaging.      Initial studies suggest that these new technologies improve upon the diagnostic accuracy of     two-dimensional transvaginal imaging in the differentiation between benign and malignant     pathology.      This improved diagnostic accuracy may promote improved patient care by separating complex     benign masses from ovarian cancer therefore facilitating appropriate treatment.   "
204606|NCT00531583|"     Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem     cell transplantation program for pts w/AML in 1st & 2nd complete remission w/no HLA matched     related donor   "
204607|NCT00531596|"     Examine adhesive and dermal tolerability of EMSAm 6mg/24hr and 12mg/24hr in healthy elderly     and non-elderly subjects.   "
204608|NCT00531622|"     The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in     combination with escitalopram 10mg once daily compared to saredutant placebo in combination     with escitalopram 10mg once daily in patients with major depressive disorder. This study also     includes a double-placebo group (saredutant placebo in combination with escitalopram     placebo).   "
204609|NCT00531635|"     Induction of mixed hemopoietic chimerism in patients using Fludarabine, Low Dose TBI, PBSC     Infusion and post transplant in immunosuppression w/CSA & Mycophenolate Mofetil   "
204610|NCT00531648|"     The researched attends to observe the relationships between toddlers that were diagnosed as     SPD and as having feeding disorder (by DSM-R-IV)and their parents.   "
204611|NCT00531661|"     This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the     United States (US). The objective of the study is to evaluate the safety and efficacy of the     HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a     subset of subjects suffering from HF.   "
204623|NCT00531817|"     This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in     combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in     signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an     inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either     tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also     received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on     study treatment was 3-12 months and the target sample size was 500+ individuals.   "
204800|NCT00522158|"     We aimed to compare the effect of achieving an LDL-cholesterol <70 vs an LDL-cholesterol <100     mg/dL with simvastatin or atorvastatin on adrenal and testicular steroidogenesis, and     cognition in diabetic patients.   "
204612|NCT00531674|"     The Mexican poverty alleviation program, Oportunidades provides a fortified food supplement     to all beneficiary children under 2 years of age, and all pregnant and lactating women.     Consumption of the supplements is well below recommended levels and the impact of the program     on child growth and anemia is less than anticipated. This is likely due to a high degree of     dilution by sharing of the supplements with other family members. We have also found evidence     of a very high prevalence of overweight and obesity among beneficiaries of Oportunidades in     both women and children.      Given the micronutrient content of the fortified food, it is likely that the impact of the     program on child growth and the micronutrient status of women and children would improve     considerable if the supplements were consumed daily in the recommended dose. This may be     difficult, given the wide-spread sharing within households - something that has been     identified by many beneficiary families as a desirable behavior. At the same time, we do not     know whether daily consumption of the food, which contains approximately 20% of daily energy     requirements, may contribute to undesirable weight gain in this population.      In this context, we have designed a cluster randomized controlled efficacy trail to compare     the nutritional impact, acceptability and use of three nutritional supplements. Supplements     were randomly assigned at the community level (n=54), and pregnant women (n=750) and children     6 to 12 mo of age (n=900) invited to participate. The principal objective of the study is to     compare the impact of Sprinkles and Nutrisano/Nutrivida using syrup/pills as a positive     control group, on child growth, weight gain and retention in pregnant women, and     micronutrient status of women and children. We hypothesize that weight gain will be greater     in the food group compared to the other two supplementation groups, but impacts on     micronutrient status and length growth in children will be similar.   "
204613|NCT00531687|"     Study Objectives:      Primary objective        -  The primary objective of this study is to investigate the combination of          cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with          germ cell tumours previously treated with BEP.      Secondary Objectives        -  Overall survival        -  Progression free survival        -  Response rates (RECIST)        -  Duration of response        -  To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients          previously treated with BEP   "
204614|NCT00531700|"     The purpose of this project is to evaluate the effects on influenza related knowledge,     attitudes and behaviors of exposure to tailored/targeted health messages and contextualized     information about influenza like illness delivered to subjects through a personally     controlled health record system. The main study hypothesis is that exposure to more intensive     levels of personalized and contextualized information about risk will result in increased     knowledge about influenza, greater attributions of immunization safety and efficacy, improved     health protecting behaviors including higher levels of appropriate immunization.   "
204615|NCT00531713|"     To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with     autoimmune hypothyroidism, on stable T4-substitution therapy   "
204616|NCT00531726|"     In this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20     patients with treatment resistant major depression will be investigated. In addition, the     stress axis, the cortical GABAergic system, neurotrophins and event-related potentials will     be assessed.   "
204617|NCT00531739|"     The purpose of this study is to determine if the use of SurgiWrapTM: (1) prevents/lowers the     incidence of Grade 2 or higher soft tissue attachments under the incision made during     abdominal surgery, (2) reduces post-operative bowel obstruction.   "
204618|NCT00531752|"     The purpose of this study is to determine whether PF-03654746 is effective in the treatment     of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized,     double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment     with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg),     and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants     will be required to washout of prior ADHD medication before entering the study. Participants     will be required to come to the site for 10 visits over approximately a 10-week period.   "
204619|NCT00531765|"     We plan to conduct an open-label, randomized, stratified, parallel-group study to compare     normal saline infusion to sodium bicarbonate infusion.   "
204620|NCT00531778|"     Improving current strategies for detection of early stage disease can impact favorably on     long-term survival of women with ovarian cancer. To reduce the morbidity and mortality of     ovarian cancer, screening for this disease must detect early stage disease rather than     advanced stage disease. Thus the challenge for the future is to identify and develop highly     sensitive and specific tumor markers that can be applied to population-based screening for     the early detection of ovarian cancer.   "
204621|NCT00531791|"     Short course of steroids in COPD exacerbation improves FEV1 and decreases the relapse rate.     However, some concerns remain about using systemic steroids for all patients with acute     exacerbation. Their short-term advantages may be outweighed by the occurrence of adverse side     effects such as hyperglycemia, which is difficult to manage on an outpatient basis. In this     context, the possibility of treating patients with COPD exacerbation with inhaled steroids     having less systemic adverse effects is interesting. The objectives are to compare relapse     rate, lung function, the severity of dyspnea and, systemic and sputum inflammatory markers in     outpatients with acute COPD exacerbations treated with fluticasone/salmeterol (Advair®) or     oral prednisone for 10 days. The hypothesis is that Advair® is as effective as prednisone in     treatment of outpatients with COPD exacerbation. The primary endpoint is to determine if the     relapse rate at one month is equivalent for both treatments. The secondary endpoints are to     compare lung function and dyspnea score and, systemic and sputum inflammatory markers     modulation after 10 days of both treatments. We will recruit 30 outpatients in each group     from our COPD clinic. Patients will receive prednisone (40mg/day) with placebo diskus or     Advair® 50/500ug 2 inhalations bid (twice the regular dose) with placebo pills for 10 days.     All patients will receive antibiotics and short-acting bronchodilators as needed. We expect     to demonstrate that the improvement of lung function, dyspnea, inflammatory markers and     relapse rate are equivalent in both treatments suggesting that Advair® could be a good     alternative to prednisone for patients with steroid-induced hyperglycemia.   "
204622|NCT00531804|"     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of     R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to     receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting     dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a     satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose.     The anticipated time on study treatment is 3-12 months, and the target sample size is <100     individuals.   "
204660|NCT00532298|"     This observer blind study is designed to compare the immune response of GSK Biologicals'     influenza vaccine GSK576389A when administered using various presentations in adults aged 65     years and older. The Protocol Posting has been updated in order to comply with the FDA     Amendment Act, Sep 2007.   "
204624|NCT00531830|"     The aim of the current research is to assess the efficiency of the Integrative Therapy among     children with PDD after a year of treatment in kindergartens in Ashdod, Israel.      An additional aim is to pinpoint specific changes in communication quality and functioning in     different areas and recognize the prognostic factors, such as social interaction, affect and     level of play. This analysis will contribute to developing more efficient treatment program,     adapted to the needs of the treated children.   "
204625|NCT00531843|"     Trauma patients are at high risk of developing deep vein thrombosis (DVT) and pulmonary     embolism (PE). The incidence of DVT varies greatly from 5-63% among studies depending on     patient's individual risk factors, modality of prophylaxis, and methods of detection. The     incidence of PE may be as low (0.3-4.3%) but carries a mortality of 20-50% which makes     prevention of DVT of the utmost importance. The current standard of care for DVT prophylaxis     in the trauma patient with high risk of DVT is enoxaparin, a low molecular weight heparin,     administered twice a day as long as anticoagulation in not contraindicated. Many studies have     demonstrated its efficacy when compared to mechanical compression and to unfractionated     heparin, however one of the most robust of these studies still reported an DVT incidence of     35% in patients treated with enoxaparin. Another drug, fondaparinux, is a selective factor Xa     inhibitor that could offer added benefits over enoxaparin such as once daily dosing and a     drastically reduced risk of heparin induced thrombocytopenia (HIT). Fondaparinux has been     already be widely used in post-operative hip surgery and major knee surgery patients with     good results. It has also been shown to be effective in DVT prophylaxis in patients who have     had major abdominal surgery and also in acute medical patients. Fondaparinux has yet to be     used in trauma patients. Trauma patients are a diverse and distinct population given the     acuity of their injuries and their increased risk of bleeding who at this time still do not     have a perfect method for DVT prophylaxis. We hypothesize that fondaparinux will be effective     in decreasing the risk of DVT when used in the trauma patient population. This is a non     randomized prospective cohort study designed to test the efficacy of fondaparinux in the     prophylaxis of DVT and PE in trauma patients.   "
204626|NCT00531856|"     The purpose of this study is to evaluate the safety and tolerability of two carbon monoxide     doses when administered as an inhaled gas for 1 hour in patients receiving kidney     transplants.   "
204627|NCT00531869|"     Consumer preferences for POU technologies vary across consumers and products, and largely     determine their adoption and subsequent usage. This is a marketing study that asks which     products consumers prefer and why, and what is their willingness to pay, as understanding     this is crucial to attain their widespread adoption and usage.   "
204628|NCT00531882|"     Inflammation clearly contributes to the progression of the cystic fibrosis (CF) lung disease,     and administration of the anti-inflammatory agent high-dose ibuprofen retards the rate of     decline of pulmonary function. However, utilization of this valuable drug has been suboptimal     because of its rare, but dramatic, adverse effects. Therefore, alternative anti-inflammatory     agents are urgently needed. One strategy for identifying new anti-inflammatory agents is to     determine the mechanism by which the only proven anti-inflammatory agent for the CF lung     disease, high-dose ibuprofen, exerts its effect. If this were known, then other drugs that     act by a similar mechanism become candidates for treating the CF inflammatory disease. The     investigators have shown, in our preliminary studies, that high dose ibuprofen limits the     delivery of neutrophils to an inflamed mucosal surface, the gingival crevices. The     investigators plan to test pioglitazone and simvastatin, (ibuprofen (positive control)) to     determine their anti inflammatory affects on neutrophil migration to the oral mucosa.      The hypothesis to be tested is that pioglitazone, and/or simvastatin will reduce neutrophils     in the oral mucosa after 10 days of therapy in mouthwashes of healthy volunteers. Ibuprofen     will be used as a positive control.      This study will provide pilot data from healthy volunteers to support an FDA Grant to be     submitted at a future date.   "
204629|NCT00531895|"     Background: Although major depression and chronic headache are strongly associated, there is     insufficient evidence on the use of antidepressants for this specific comorbidity. This trial     aimed to investigate the efficiency and tolerability of duloxetine for this indication.      Methods: Thirty outpatients of our clinic, with DSM-IV major depression and concurrent     primary chronic headache (chronic migraine, chronic tension-type headache or both), 18-55     years, were recruited from April 2006 to March 2007, if they scored >21 on the     Montgomery-Äsberg Depression Scale (MADRS) and had no other significant clinical condition.     Subjects received duloxetine 60 mg/day for 8 weeks. MADRS scores and a visual analog pain     scale (VAS) were the co-primary outcome measures. WHO quality of life scale (WHOQoL BREF)     scores and headache days/week were secondary outcome measures.Conclusion: In this preliminary     open trial, duloxetine 60 mg/day was effective, fast acting and well tolerated for the     treatment of comorbid major depression and chronic headache.   "
204630|NCT00531908|"     Acromegaly is a disease due to an excess of growth hormone that abnormally occurs in     adulthood. It is due to a benign (non cancerous) tumor located in a particular part of the     brain that secretes several hormones, the hypophysis. The excess of growth hormones in adults     induces an increase in bone (resulting in large enlargement of extremities), and organs. The     disease is complicated by the apparition of cardiovascular events including retention of     water, salt in the tissues and increase in blood pressure, that altogether might major the     mortality of the patients. The investigators recently got experimental data suggesting that     the retention of water and salt is mainly due to the activation by the growth hormone of a     renal transporter of sodium. Because this transporter is highly sensitive to amiloride, a     well know diuretic, the investigators hypothesize that this drug will be very efficient in     treating the hypertension in patients, as compared to another diuretic, furosemide.   "
204631|NCT00531921|"     Activity of genes in donor tissues that are involved in inflammation are thought to be     involved with early organ dysfunction, increased immune responses in transplant recipients,     and organ rejection. The purpose of this study is to determine the relationship between     genetic expression in donor and recipient tissue with transplant survival. Participants in     this study will have received heart, lung, liver, or kidney transplants.   "
204632|NCT00531934|"     This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with     non-small cell lung cancer who have failed first-line chemotherapy for advanced disease.     Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no     preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated     time on study treatment is until disease progression or intolerable toxicity, and the target     sample size is 100-500 individuals.   "
204633|NCT00531947|"     The primary purpose of your participation in this study is to help answer the following     research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is     safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major     Depressive Disorder (MDD).   "
204634|NCT00531960|"     This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and     chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small     cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus     Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus     Avastin. The anticipated time on study treatment is until disease progression, and the target     sample size is 100-500 individuals.   "
204635|NCT00531973|"     The randomized LITE study will compare liposomal doxorubin versus standard epirubicin in the     treatment of female breast cancer. In order to detect as early as possible post-chemotherapy     cardiotoxicity, tissue Doppler imaging parameters elicited at transthoracic echocardiography     will be used and will constitute the primary and co-primary end-points.   "
204636|NCT00531986|"     The investigators plan to conduct a two arm study, to compare failure rates in the central     nervous system (CNS) and genital compartment in virologically fully suppressed patients     continuing a highly active antiretroviral therapy (HAART) versus patients switching to     ritonavir boosted lopinavir (Kaletra®) HIV-monotherapy. The study is composed of two phases     of 48 weeks duration.      In addition, neuropsychological tests (Color trial test A 1 and 2; Grooved pegboard; EWIA     Digit Symbol form) and evaluation of side effects will be performed.   "
204637|NCT00531999|"     The purpose of the study is to look at the effects of two different HIV medications on the     body's response to insulin (a hormone that regulates blood sugar levels). This will be done     using a method called the 'euglycaemic clamp'      The study will also investigate the effects of these drugs on blood fats and on circulating     markers in the blood stream related to blood vessels (vascular inflammation markers).   "
204638|NCT00532012|"     The drug that is under investigation during this study is RhuDex® and is expected to be used     as an oral treatment for rheumatoid arthritis. Normal stomach juices contain acid and     previous studies have shown that this acidity reduces the solubility and therefore the     absorption of RhuDex®. Administering the alkaline buffer meglumine with RhuDex® has shown to     increase the solubility of RhuDex® by decreasing the stomach acidity.      The purposes of this study are to determine:        -  the optimum level of meglumine which is required to achieve the best uptake of RhuDex®          from the stomach into the blood        -  to determine the concentration of RhuDex® in the blood in the presence of the optimum          level of meglumine        -  to investigate further the safety and tolerability of RhuDex®. The study will be          conducted in healthy male volunteers.   "
204639|NCT00532025|"     This is an open-label, single-armed, multicentric, phase II study of Sorafenib treatment     following surgery for NSCLC.      The primary hypothesis is to increase the progression-free survival (PFS) of the experimental     group in comparison to a historical control group. For sample size calculation a 2 year PFS     of 50% was calculated for the historical control group, and a 2 year PFS of 67% was estimated     for the intervention group. These estimates are based on the actual PFS and overall survival     (OS) of a defined population of 120 NSCLC patients treated at a single institution with     surgery alone or surgery followed by adjuvant radiotherapy, which compares favorably to     published international results, and the improvement of PFS achieved by 4 cycles of     cisplatin/vinorelbine-based cytotoxic chemotherapy in published randomized trials.   "
204640|NCT00532038|"     ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD     (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated     with osteoarthritis. This study will evaluate the safety of long-term administration of     ThermoProfen™ for the pain associated with osteoarthritis of the knee in adults. The study     will be conducted in patients with pain associated with osteoarthritis and who have completed     a previous efficacy study of ThermoProfen.   "
204641|NCT00532051|"     The long-term goal of this project is to utilize newly available very high-speed optical     coherence tomography (OCT) technology to guide surgical treatments of corneal diseases. OCT     is well known for its exquisite resolution, but until recently it has not had sufficient     speed to capture the shape of the cornea because of eye motion during OCT scanning. The     development of Fourier-domain (FD) OCT technology has made the requisite speed possible.      The objective of this project is to develop methods for imaging the cornea with an FD-OCT     system that will precisely measure corneal shape and use this information to guide surgery.     Cataract surgery in patients with previous laser vision correction often leads to significant     near- or far-sightedness, a problem that could be resolved by using a more accurate     intraocular lens power selection formula based on the measurement of corneal refractive power     with OCT.   "
204642|NCT00532064|"     Primary Objective:      -To determine if specific biomarkers (Troponin I and B-type natriuretic peptide [BNP]) detect     cardiotoxicity earlier than standard clinical means in patients receiving Sunitinib Malate     (SU11248) or Sorafenib chemotherapy.      Secondary Objective:      -To prospectively evaluate the incidence and severity of cardiac toxicity related to     sunitinib or sorafenib during chemotherapy.   "
204643|NCT00532077|"     SB-751689 may alter calcium and phosphate handling at the kidney level. This study will     examine what happens to calcium and phosphate, and other electrolytes, at the kidney after     treatment with SB-751689 for 1 month. Another group of subjects will get another drug called     Forteo for 1 month to compare the response of the kidney for calcium and phosphate.   "
204644|NCT00532090|"     This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of     R4733 (RO4929097), administered orally to patients with refractory metastatic or locally     advanced solid tumors. The study will assess three different dosing schedules; in one     schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21     day cycle, and in a third schedule continuously daily. The starting dose for each dosing     regimen will be escalated in subsequent groups of patients after a satisfactory assessment of     the safety and tolerability of the previous dose. The anticipated time on study treatment is     until disease progression or dose-limiting toxicity, and the target sample size is 100-200     individuals.   "
204645|NCT00532103|"     This study will develop a new methodology to evaluate any treatment-emergent suicidal     ideation that might occur when an antidepressant treatment has been started and/or during     times when doses are increased in patients with major depressive disorder.   "
204646|NCT00532116|"     Evaluate the effect of age on the PK of two different doses of EMSAM.   "
216430|NCT00683423|"     The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in     diabetic patients.   "
204647|NCT00532129|"     This single arm study will assess the safety and effect on response rate of a combination of     rituximab and chlorambucil in previously untreated participants with B-cell chronic     lymphocytic leukemia. Participants will receive 6 monthly cycles of combination treatment,     followed by up to 6 cycles of chlorambucil alone. Rituximab will be administered on Day 1 of     each cycle, at a dose of 375 milligrams per square meter (mg/m^2) intravenously (IV) in Cycle     1, and 500 mg/m^2 in subsequent cycles, and chlorambucil will be administered on Days 1-7 of     each cycle at a dose of 10 mg/m^2/day per oral (PO).   "
204648|NCT00532142|"     The ROVO study is a prospective, placebocontrolled and randomised study designed to evaluate     the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone     acetonide. 240 patients with a visual acuity < 0.5 Snellen will be randomised. Patients are     treated with either RON, or a single intravitreal injection of 4 mg triamcinolone acetonide,     or a placebo treatment - a sham injection of intravitreal triamcinolone. Patients will be     examined regularly over a period of one year.      Best corrected visual acuity for far and near, as well as clinical examinations, fluorescein-     and indocyanine green angiograms, optical coherence tomography, and perimetry, are performed     pre- and postoperatively.   "
204649|NCT00532155|"     The primary objective of the study was to demonstrate overall survival improvement for     aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for     participants with locally advanced or metastatic non-small cell lung cancer (NSCLC).      The secondary objectives were to compare other efficacy parameters, to assess the overall     safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV)     aflibercept in this participant population and to determine immunogenicity of IV aflibercept     in all participants.   "
204650|NCT00532168|"     There are few randomized clinical trials in advanced HIV patients. This is a multicenter,     randomized, open clinical trial, comparing three parallel groups, to compare the     immunological reconstitution and the virological efficacy and safety of three different     combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine     plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in     advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3.     Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting     HAART.   "
204651|NCT00532181|"     People who buy insurance are sicker and/or more risk averse than those who don't. Also,     Micro-health insurance increases utilization of public health care facilities and protects     against asset sales.   "
204652|NCT00532194|"     The purpose of this study is to assess the safety and efficacy of cediranib in combination     with standard chemotherapy, in patients who have relapsed with ovarian, fallopian tube or     epithelial cancer, after first line platinum based treatment.   "
204653|NCT00532207|"     To see if using teriparatide for 12 months will increase Bone Mineral Density at the lumbar     spine in postmenopausal women with osteoporosis   "
204654|NCT00532220|"     BACKGROUND: Bone marrow edema (BME) in the knee occurs as a localized inflammatory disease in     relation to spontaneous or non-traumatic osteonecrosis (ON). Prognosis of BME/ON in the     course after knee arthroscopy appears to be poor and in most cases results in knee     arthroplasty. Treatment options of ON depend in general on the size of the lesion. Smaller     lesions are managed by mechanical unloading and use of non-steroidal anti-inflammatory drugs,     larger lesion in general requires osteotomy or arthroplasty. In animal studies it has been     shown that bisphosphonates prevent resorption of necrotic bone during ischemic necrosis and     revascularization. In humans, bisphosphonate treatment has been used successfully in bone     marrow oedema and avascular necrosis of the femoral head.      In an observational study using bisphosphonates (ibandronate, pamidronate) in patients with     either spontaneous or (believed to be) arthroscopy-induced BME of the knee a significant     rapid and sustained pain relief was observed with a mean decrease on the pain scale on the     visual analogue scale of over 60% after 3 months and of 80% after 6 months. Our experience     suggests an apparent beneficial effect of amino-bisphosphonates in the treatment of BME of     the knee.      AIM: This randomized, double-blind, placebo-controlled study aims to provide data on     clinical, biochemical and radiological outcome of patients with bone marrow edema in relation     to spontaneous or arthroscopy-induced ON of the knee treated with ibandronate or placebo.      ENDPOINTS: The primary objective is to demonstrate the superiority of treatment with     ibandronate compared to placebo regarding clinical outcome (pain [VAS score]) in spontaneous     or arthroscopy-induced BME/ON of the knee after 12 weeks. Secondary objectives include a)     clinical outcome (pain [VAS score]) after 24 weeks, b) the evaluation of the radiological     outcome (MRI scan) at 12 and 48 weeks, c) the changes in biochemical markers of bone     turnover, and d) the number of salvage therapies needed in case persistence is observed     during placebo therapy.      METHODS: The study is designed as a single-center, randomized double-blind,     placebo-controlled trial. A total number of 30 patients with BME/ON will be recruited. Each     patient will be randomized in a 1:1 ratio to receive ibandronate IV or placebo IV.     Additionally, all patients will receive 500 mg calcium and 400 IU vitamin D per day     throughout the study, and diclofenac/esomeprazole for initial 3 months (blinded treatment     duration 24 weeks). Baseline and follow-up data collection will contain all variables needed     for evaluation of clinical, biochemical and radiological evaluation of treatment efficacy.      EXPECTED RESULTS: We hypothesize that treating patients with BME/ON of the knee, therapy with     ibandronate will be superior in reducing pain, and radiological findings as compared to     placebo.   "
204655|NCT00532233|"     The purpose of this study is to investigate how QAX576 affects levels of interleukin 13     (IL-13) in patients with idiopathic pulmonary fibrosis (IPF).   "
204656|NCT00532246|"     The purpose of this study is to measure carotid artery IMT at a single visit in a subset of     women previously enrolled in the CORE (H3S-MC-GGJY) trial   "
204657|NCT00532259|"     Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is     the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL)     following relapse of the disease. Although many people are cured of their lymphoma with this     therapy, the disease comes back in a certain proportion of patients. The purpose of this     study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients     with DLBCL who have received autologous peripheral blood stem cell transplantation. All final     eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post     autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with     treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be     conducted throughout the study till 18 months post autologous PBSCT. Approximately 70     patients will participate in this study.   "
204658|NCT00532272|"     Primary objective is to evaluate the response rates and clinical benefits of letrozole +     goserelin in premenopausal patients versus letrozole alone in postmenopausal patients with     metastatic breast cancer as first line hormonal therapy   "
204659|NCT00532285|"     This is an open labeled phase II single arm trial. The patients with clinical stage II and     III will undergo core-needle biopsy of breast tumor for histologic diagnosis,     immunohistochemical studies for estrogen receptor (ER), progesterone receptor(PR), HER-2/neu     and others. PET or ultrasound results will determine the positivity of lymph node metastasis.   "
204661|NCT00532311|"     The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily     (QD), taken with statins on cholesterol levels in subjects with hypercholesterolemia   "
204662|NCT00532324|"     Background:      Community acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) is an emerging     pathogen of the 21st century whose incidence as a cause of local and invasive infections has     significantly increased, especially in previously healthy term and near term newborns. The     etiology of the increasing incidence of infection in previously healthy term and near-term     newborns remains unclear.      Hypothesis:        1. The incidence of previously healthy newborns infected with CA-MRSA skin & soft tissue          (SSTI) and invasive infections is higher in those born to mothers colonized with          CA-MRSA.        2. Pregnant women colonized with CA-MRSA are at higher risk for post-partum infection with          this organism.      Specific Aims:        1. To determine the incidence of nasal and vaginal colonization with CA-MRSA in pregnant          women and determine the genetic similarities of these strains.        2. To study CA-MRSA transmission dynamics and evaluate the incidence of SSTI and invasive          infections in newborns born to S. aureus colonized mothers.        3. To study the efficacy of attempted decolonization in CA-MRSA colonized mothers in          decreasing the incidence of transmission and development of SSTI and invasive infections          in their infants during the first month of life.      Potential Impact:      Understanding the epidemiology of the transmission dynamics of CA-MRSA in previously healthy     newborns will provide important information to support the development of strategies aimed at     the interruption of transmission and prevention of infection caused by CA-MRSA in newborns,     as well as in pregnant women. This will also allow for the development of infection control     strategies to prevent the spread of this organism among post-partum units and nurseries.   "
204663|NCT00532337|"     The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in     postmenopausal women with osteopenia or osteoporosis.   "
204664|NCT00532350|"     This study will assess the safety and tolerability of QAT370 compared to tiotropium in     patients with COPD.   "
204665|NCT00532363|"     Clinicians frequently observed that obese women referred for severe asthma do not respond to     treatment. These patients, despite the presence of wheezing, often have normal expiratory     flows and normal or borderline airway responsiveness.      It is therefore possible that this mode of presentation reflect a pseudo-asthmatic state for     which clinical definition and characteristics and optimal management remain to be determined.      The aim of this study was to study the pulmonary physiological and airway inflammatory     characteristics and response to treatment of obese women considered to have clinically severe     asthma in order to demonstrate that some of these patients have a phenotype that is not that     of asthma.   "
204666|NCT00532376|"     Depression is very common in epilepsy. Depression is the strongest predictor of poor quality     of life in patients with epilepsy. The biological basis for depression in epilepsy remains     poorly understood. This study uses functional MRI (fMRI) to examine brain response to     emotional and non-emotional stimuli in healthy control subjects and in patients with epilepsy     who are either depressed or not depressed. Results from this study will contribute to a     better understanding of depression in epilepsy, which may eventually inform development of     better treatment modalities..   "
204667|NCT00532389|"     This study comprises of a dose-escalation and dose expansion phase and will determine the     maximum tolerated dose of oral Panobinostat on a continuous schedule in adult in combination     with bortezomib. Safety, tolerability, PK and PD profile of the combined treatments will be     assessed as secondary objectives. Dose expansion phase will explore in a non continuous     Panobinostat schedule with bortezomib and dexamethasone, safety and tolerability and PK     profile of Panobinostat and Bortezomib with and without Dexamethasone   "
204668|NCT00532402|"     This study should compare the propofol concentration in breathing gas and in plasma (before     and) after lung passage. Propofol concentrations in breathing gas are continuously measured     by a sensor. For comparison a discontinuous method is used. Neurophysiologic parameters for     determination of depth of anesthesia are compared to the continuous measured propofol     concentration in breathing gas.      Study hypothesis: continuous measured propofol concentration in breathing gas correlates to     propofol concentration in plasma and depth of anaesthesia.   "
204669|NCT00532415|"     The purpose of this study is to evaluate the safety and efficacy of triamcinolone acetonide     suspension when used for visualization of structures in the back of the eye during eye     surgery.   "
204670|NCT00532428|"     This is a cross-sectional study to determine, via iliac crest bone biopsies, the effect of     long-term treatment with raloxifene on histomorphometry and bone quality in patients who     participated in the Continuing Outcomes Relevant to Evista Study.   "
204671|NCT00532441|"     An unmet medical need exists for the successful therapy of patients with advanced     hepatocellular and biliary tract malignances, with few and short lived disease responses to     chemotherapy for both advanced stage hepatic and biliary carcinomas. Pre-clinical data shows     cooperative antitumor activity between an epidermal growth factor receptor (EGFR) tyrosine     kinase inhibitor and taxanes. The efficacy of erlotinib in combination with docetaxel will be     assessed in this trial.   "
204672|NCT00532454|"     Primary objectives of this study is to evaluate the effects of CYP2D6 genotypes on time to     progression after tamoxifen treatment in pre- or postmenopausal women with metastatic breast     cancer. Furthermore, we will evaluate the effects of CYP2D6 genotypes on clinical benefit and     response duration to tamoxifen administration in pre- or postmenopausal women with metastatic     breast cancer and also evaluate the effects of CYP2D6 genotypes on the steady state plasma     concentration of tamoxifen and its metabolites   "
204673|NCT00532467|"     This study is the second study to evaluate SRX251 in healthy volunteers and it represents the     first multiple dose study. The primary objective of this study is to evaluate the safety and     tolerability of escalating multiple oral doses of SRX251 capsules for 5 days in healthy adult     volunteers. Levels of the drug in blood plasma will also be determined.   "
204674|NCT00532480|"     The purpose of this study is to find out what parts of the brain have increased or decreased     activity when people are depressed and how antidepressant medicine changes this activity in     depressed patients. The genetic samples collected are to look at variation in a gene     (serotonin transporter gene), which affects the functioning of the chemical serotonin in the     brain   "
204675|NCT00532493|"     Background: Posttraumatic stress disorder (PTSD) is a debilitating and disabling mental     disorder that afflicts at least 25% of Veterans who have suffered life-threatening war zone     trauma. Trauma-related nightmares and sleep disturbance are among the most     treatment-resistant PTSD symptoms in Veterans. Increased responsiveness to central nervous     system (CNS) norepinephrine (NE) contributes to the pathophysiology of overall PTSD and     treatment-resistant nighttime symptoms. Placebo-controlled pilot studies demonstrate that the     generically available CNS-active alpha-1 adrenoreceptor antagonist prazosin substantially     reduces PTSD trauma nightmares and sleep disturbance and improves global clinical status     (sense of well being and ability to function) in Veterans.      Objective: The primary objective is to demonstrate in a large multi-site placebo-controlled     trial in Veterans with war zone trauma-induced PTSD that prazosin is efficacious for PTSD     trauma nightmares, sleep disturbance, and global clinical status. A secondary objective is to     demonstrate prazosin effectiveness for these outcome measures during clinically meaningful     long-term (26 week) maintenance treatment of PTSD. The investigators will also address     prazosin efficacy and long-term effectiveness for improving total PTSD symptoms, comorbid     depression, quality of life, and physical functioning.      Methods: This 26 week randomized double-blind placebo-controlled study is designed to     demonstrate both short term efficacy and long term effectiveness of prazosin for PTSD. The     research design encompasses a shorter-term, more tightly controlled efficacy component and a     longer-term, more .real world. effectiveness component. Three hundred twenty-six Veterans     with war zone -related PTSD and persistent trauma nightmares will be randomized 1:1 to     prazosin or placebo. Study drug will be increased using a flexible dose titration schedule     based on clinical response and adverse effects to an optimum maintenance dose (1-20 mg/day).     During the first 10 weeks of the study, participants will be randomized to prazosin or     placebo. Previous psychotropic medications and/or psychotherapy will be maintained constant.     Short term efficacy will be determined during the first 10 weeks. During the remaining 16     weeks of the 26 week trial, subjects will continue to receive stable-dose double-blind     prazosin or placebo, but will have the option to receive additional psychotropic medications     and/or psychotherapeutic interventions, as needed, per the judgment of the study Clinician     Prescriber. It is hypothesized that prazosin will remain more clinically effective than     placebo at the end of the 26-week trial, demonstrating that prazosin adds benefit     over-and-above other treatments that are naturalistically administered by providers in a     .real world. clinical setting.      Prazosin will be judged efficacious at 10 weeks if superior to placebo on all three primary     outcome measures assessing trauma nightmares, sleep disturbance, and global clinical status:     the Recurrent Distressing Dreams item of the Clinician Administered PTSD Scale (CAPS), the     Pittsburgh Sleep Quality Index (PSQI), and the Clinical Global Impression of Change (CGIC).     Secondary outcome measures will assess prazosin effects on total PTSD symptoms, depression,     physical functioning, and quality of life. Adverse effects and cardiovascular measures,     including supine and standing blood pressure (BP) and heart rate (HR) will be assessed.   "
204676|NCT00520520|"     Mild therapeutic hypothermia is indicated in patients surviving out-of-hospital cardiac     arrest due to ventricular fibrillation. Potential immunologic responses are unknown.   "
204678|NCT00520546|"     To investigate the sensitivity of the [18F]fluoroethylcholine (FEC)     Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) method in tumour detection     and location (side assignment, encapsulation, invasion of the seminal vesicle) and detection     of affected lymph nodes, and to compare these with presently used detection procedures     (needle biopsy, digital rectal examination, transrectal ultrasound, and pre-therapeutic     assessment), with a view to finding out whether the [18F]fluoroethylcholine PET/MRI method is     comparable to, or superior to, the established method. Postoperative histology served as the     standard of reference.   "
204679|NCT00520559|"     The purpose of this study is to provide accurate prognostic data linking cardiac     complications to myocardial T2* values (A measure of iron levels in the heart using MRI)in     patients predisposed to heart iron overload.   "
204680|NCT00520572|"     The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid     arthritis with regard to signs and symptoms and to determine what dose is favourable over a     6-month treatment period. Patients will receive background treatment with either Methotrexate     or Sulphasalazine   "
204681|NCT00520585|"     The aim of this study is to evaluate influence of atorvastin on the repolarisation phase of     cardiomyocytes. If there is any, it could be a part of positive non-lipid effect of statins     in therapy of ischaemic heart disease.      Study hypothesis: atorvastin will decrease heterogeneity of repolarisation of cardiomyocytes     in comparison with placebo   "
204682|NCT00520598|"     The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison     to GARDASIL (TM)   "
204683|NCT00520611|"     Obesity is a major cause of premature aging and the second leading cause of preventable     mortality in the United States, accounting for approximately 110,000 deaths per year.     Financial incentives have been effective in modifying a number of health behaviors but they     have rarely been applied to weight loss, and to the best of our knowledge never to weight     loss by low-SES obese veterans.      We propose testing two different approaches to using financial incentives to encourage weight     loss. In the first, we build on previous work showing the effectiveness of 'deposit     contracts', in which subjects are given the opportunity to put their own money at risk if     they do not lose weight. In this incentive condition, subjects receive a direct payment     conditional on daily weight loss, and an optional additional payment based on their own     contributions to the deposit contract. We will match their contribution 1:1 to make the     option of depositing their own money attractive to this predominantly low SES population. In     the second approach we build on our own prior work using lotteries to promote drug adherence.     In this incentive condition, participants are entered into a daily lottery, and receive any     payoffs they earn from the lottery only if they stay on track with their weight-loss goal.     Given their popularity in the general population, lotteries hold the promise of providing a     cost-effective means of motivating weight loss and making efforts to lose weight more salient     to obese patients.   "
204684|NCT00520624|"     Treatment of exercise-induced laryngomalacia (an obstruction of larynx during physical     activity) in elite athletes using two different treatments. The study is randomized with     control groups.   "
204685|NCT00520637|"     The goal of this clinical research study is to find the highest tolerable dose of EZN-2208     that can be given to patients with advanced cancer or lymphoma. The safety of the study drug     and its effect on the disease will also be studied.      Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the     amount of a drug in the body at different time points.   "
204686|NCT00520650|"     This is a post-market surveillance, and the treatment to patients will be depended upon the     decision based on physician's clinical judgment. The health profiles during the switching     period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will     be recorded and evaluated.   "
204687|NCT00520663|"     The purpose of this study is to define the absorption, breakdown and excretion of a single     dose of radiolabelled SB-649868 and its breakdown products by measuring their concentration     in blood, urine and faeces over a 7-10 day period. Radiolabelled means that the test drug     has a radioactive component to help us track the drug. The safety and tolerability of the     test drug will also be assessed.   "
204688|NCT00520676|"     The purpose of this study is to compare the combination of pemetrexed and carboplatin with     the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4     toxicity in previously untreated patients with locally advanced or metastatic non-small cell     lung cancer (NSCLC).   "
204689|NCT00520689|"     The purpose of this study is to verify the compatibility of a silicone hydrogel lens when     used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®,     Solo-Care Aqua™ and MeniCareTM Soft).   "
204690|NCT00520702|"     Primary Objective:        -  Developing Common Toxicity Criteria (CTC) 3.0 grade > 3 treatment related pneumonitis          (TRP) or        -  Developing local-regional recurrence among patients treated with 3D conformal radiation          therapy (CRT) (Arm 1) or intensity modulated radiation therapy (IMRT) (Arm 2).      Secondary Objectives:        -  To assess and compare the time to develop CTC 3.0 grade > 3 radiation esophagitis in          patients with non-small cell lung cancer (NSCLC) treated in arm 1 and arm 2.        -  To investigate the association of inflammatory cytokines with the time to the          development of radiation pneumonitis and outcomes to concurrent chemoradiation between          arm 1 and arm 2.        -  To investigate the association of relevant pharmacogenetics, biomarkers, and gene          polymorphisms with the time to the development of radiation pneumonitis and treatment          outcomes to concurrent chemoradiation between arm 1 and arm 2.        -  To evaluate image guided adaptive radiation therapy (IGART) using weekly computed          tomography (CT) on rail or cone beam CT in the assessment of tumor response and impact          on treatment planning and delivery.        -  To compare overall survival, progression-free survival, median survival time, in arm 1          and arm 2.        -  To evaluate the role of functional image of fluorodeoxyglucose-positron emission          tomography (FDG-PET) in assessing and predicting the time to the development of TRP and          tumor response.        -  To measure and compare symptom burden over time of the treatment using MD Anderson          Symptom Inventory (MDASI)-Lung in the 2 arms.        -  To determine the impact of comorbid conditions on survival.   "
204801|NCT00522171|"     The objective of this study is to determine if the use of The Harmonic™ (an ultrasonic     surgical instrument) in Lower Body Lift procedures reduces volume and duration of wound     drainage after surgery when compared to Electro Surgery.   "
204691|NCT00520715|"     Emergence of bacterial resistance to antibiotics, which is a major public health issue,     appears to involve predominantly commensal flora. No data exists concerning risk factors for     the carriage of fluoroquinolone resistant bacteria in the flora of hospitalised patients. We     will conduct a prospective open study including all unselected patients hospitalised in     medical wards of one hospital. Nasal, pharyngeal and rectal swabs will be performed upon     admission as well as a review of potential risk factors, after patient's information and     acceptance. Resistance testing aiming 3 pathogens (Staphylococcus, Streptococcus and E. coli)     will be performed on all specimens, and a case control study will compare risk factors from     the resistant and non-resistant groups, for each pathogen. A thousand patients should be     included in a year's time. This work could help understand risk factors involved in the     carriage of fluoroquinolone resistant pathogens, potentially responsible for invasive     infections and inter-patient transmission of resistance. Limiting bacterial resistance and     transmission is a goal that can be successfully undertaken only if resistance mechanisms, but     also risk factors of acquiring resistant bacteria are better understood.   "
204692|NCT00520728|"     The purpose of this study is to test the efficacy of a new Occupational Time Use Intervention     designed to increase activity participation and improve meaning in the lives of people with     serious mental illness living in the community.   "
204693|NCT00520741|"     The objective of this historical-controlled trial is to demonstrate the efficacy and safety     of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are     withdrawn from 1 to 2 marketed antiepileptic drugs.   "
204694|NCT00520754|"     Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other     Allergic Symptoms in Children   "
204695|NCT00520767|"     RATIONALE: Giving bortezomib together with melphalan and dexamethasone may be an effective     treatment for primary amyloidosis and light chain deposition disease.      PURPOSE: This phase II trial is studying how well giving bortezomib together with melphalan     and dexamethasone works in treating patients with primary amyloidosis or light chain     deposition disease.   "
204696|NCT00520780|"     This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in     patients with iron deficiency. Analyses will focus both on subjective and objective measures.     Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.   "
204697|NCT00520806|"     Different doses of relaxin will be compared to placebo to determine efficacy and safety for     the treatment of patients hospitalized with acute heart failure   "
204698|NCT00520819|"     The primary objective of this study is to test whether increasing the total intake of     antioxidants to middle-aged smoking men increases the antioxidant defence, reduces oxidative     damage, and improves biomarkers for oxidative stress.      The secondary objectives is to test whether this strategy improves other cardiovascular risk     markers including platelet function, lipid levels, inflammation, and markers of endothelial     damage.   "
204699|NCT00520832|"     Participants identified as having primary insomnia will be randomly assigned to groups     receiving microcurrent stimulation or sham in a double-blind randomized controlled trial. The     microcurrent device used is FDA approved for the treatment of insomnia.      The hypothesis is that the experimental group will have significantly improved scores on     three sleep surveys after treatment while the sham group will not.   "
204700|NCT00520845|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes need     for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving celecoxib together with docetaxel or pemetrexed may kill more tumor cells.      PURPOSE: This phase II trial is studying how well celecoxib given together with docetaxel or     pemetrexed works in treating patients with advanced or recurrent non-small cell lung cancer.   "
204701|NCT00520858|"     The prevalence of abdominal obesity in the elderly is increasing at alarming rates and thus,     requires immediate attention. By comparison to younger adults, obesity reduction in the     elderly presents a unique challenge and requires an innovative approach. We propose a novel     approach to investigate the effects of different exercise types as independent treatment     strategies for the reduction of obesity and related health risk factors in older men and     women. We propose that exercise without caloric restriction will be associated with modest     weight loss (3-5%), that in turn will be associated with significant reduction in abdominal     obesity, insulin resistance, and a corresponding increase in skeletal muscle mass and     function. We will determine the separate effects of resistance and aerobic exercise on these     primary outcome variables, and, whether a treatment strategy that combines the two is     optimal.   "
204702|NCT00520871|"     We will study the effect of supplementation of 1 L blueberry juice to participants with at     least one elevated cardiovasculat risk factor.   "
204703|NCT00520884|"     The purpose of this research study is to see if giving women a hormone called ghrelin will     increase levels of growth hormone in the blood and increase appetite. Ghrelin is a naturally     occurring hormone that is produced mostly by the stomach and causes secretion of another     hormone called growth hormone. It also increases short-term appetite and may lower the amount     of inflammation in the body.      Some people lose their appetite as they age and have unintentional weight loss. This may be     caused by a break in the communication between the stomach and the brain. We are particularly     interested in seeing if there is a difference in the effects of ghrelin in older women who     have lost weight recently without wanting to and those who have not.   "
204704|NCT00520897|"     The eradication of HIV by antiretroviral therapy has thus far been elusive. It has been     consistently demonstrated that a pool of latently infected, resting CD4+ T cells persists in     the majority of HIV-infected individuals receiving antiretroviral therapy in whom plasma     viremia has been successfully suppressed for prolonged periods of time; this pool has emerged     as the major obstacle in achieving the eradication of HIV. We believe that MK-0518 can     further the decay and suppression of HIV-1 in patients who have been virologically suppressed     for a prolonged period of time on effective cART (≥ 4 years).   "
204714|NCT00521027|"     The purpose of this study is to compare the VERSAJET™ device with conventional surgical     procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of     lower limb ulcers.      It is hypothesised that the time taken to debride lower limb ulcers will be quicker with the     VERSAJET™ device than with conventional surgical procedures.   "
204705|NCT00520910|"     With this study we will like to determine if taking a dose of the study medication, called     Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse     effects of UVA, a type of ultraviolet light. Ultraviolet light is a form of radiation which     is not visible to the human eye. The sun produces different types of ultraviolet radiation,     and UVA is one of them. More than 95% of the solar UV energy that reaches our skin is from     the UVA type. UVA penetrates cloud cover and glass windows.      PL extract comes from a tropical fern plant grown in Central and South America, and it is a     dietary supplement available in the US. No side effects have been reported with Polypodium     leucotomos extract since becoming commercially available in 1982. Also, PL extract was     approved for oral use by the Institutional Review Board of The Massachusetts General     Hospital, Boston, for studies by Harvard Medical School faculty in human volunteers that were     carried out for a period of two years, using artificial light and sunlight as ultraviolet     sources.      This is an investigator-blinded study, which means that the doctor evaluating you will not     know if you are receiving the study medication or not. Another doctor will be supplying you     with the medication and discussing any problems that you may have with the medication.      You will be assigned to one of the two treatment groups. The group will be assigned by chance     and you will have a one in two chances of receiving either the study medication or no     treatment.   "
204706|NCT00520923|"     The purpose of this study is to test the hypothesis that 1 or more dose levels of LY2140023     given orally to patients with schizophrenia twice daily for 4 weeks will have significantly     greater effect than placebo.   "
204707|NCT00520936|"     To determine the response rate of pemetrexed given every 21 days for the treatment of     children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive     neuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma,     medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.   "
204708|NCT00520949|"     Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold     standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and     either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an     increasing evidence of H. pylori resistance to classical triple therapy. Another reason for     this failure being low patient compliance with treatment. A regimen useful in one     geographical area may not be effective or practical in another area. The aim of this study     was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and     safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed     with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14     days.   "
204709|NCT00520962|"     The study aims to evaluate IFG, IGT or unknown type 2 diabetes mellitus in new classes at     high risk to develop alterations of glucose metabolism and definition of new pathogenic     mechanisms of insulin resistance and atherosclerosis.      The following classes of subjects at high risk will be considered:First degree relatives of     patients with type 2 diabetes mellitus, patients with cardiovascular disease and stroke,     patients with heart valve disease. age will be > 30 years, both gender.   "
204710|NCT00520975|"     This randomized phase III trial studies first-line chemotherapy and trastuzumab to compare     how well they work when given with or without bevacizumab in treating patients with breast     cancer that overexpresses human epidermal growth factor receptor 2 (HER-2/NEU) and has spread     to other areas of the body. Drugs used in chemotherapy, such as paclitaxel and carboplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such     as trastuzumab and bevacizumab, may interfere with the ability of tumor cells to grow and     spread. Bevacizumab may also stop the growth of breast cancer by blocking the growth of new     blood vessels necessary for tumor growth. It is not yet known whether giving first-line     chemotherapy together with trastuzumab is more effective with or without bevacizumab in     treating patients with metastatic breast cancer that overexpresses HER-2/NEU.   "
204711|NCT00520988|"     We will improve hypertension control in Colorado by implementing a population-based     intervention using interactive voice response (IVR) technology that will be delivered to     patients in three healthcare systems across Colorado (Denver Health and Hospitals [DH], VA     Colorado Healthcare System [VA], and Kaiser Permanente of Colorado [KPCO]). Together, these     organizations serve over 1 million Coloradans. The IVR-based hypertension program will: 1)     reach out to more patients using fewer resources than a traditional patient visit approach,     2) implement evidence based guidelines for therapy, 3) facilitate patients' acquisition of     medications by allowing them to order and receive medications at home, and 4) enhance     medication adherence using tailored educational and motivational messages.      HYPOTHESES:        1. A sizable population of patients is at high risk for further cardiovascular morbidity          and mortality, based on uncontrolled hypertension.        2. An IVR-centered intervention among patients with diagnosed but uncontrolled hypertension          is feasible.        3. An IVR-centered intervention plus usual care for these patients improves BP control,          compared to usual care alone.   "
204712|NCT00521001|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by     blocking some of the enzymes needed for cell growth. Giving everolimus together with     temozolomide may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving everolimus together with     temozolomide works in treating patients with stage IV melanoma that cannot be removed by     surgery   "
204713|NCT00521014|"     RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant helps stop     the growth of cancer cells by stopping them from dividing or by killing them. An autologous     stem cell transplant may be able to replace the blood-forming cells that were destroyed by     chemotherapy. GM-CSF may increase the number of immune cells found in bone marrow or     peripheral blood. Giving a monoclonal antibody, such as rituximab, after the transplant may     find any remaining cancer cells and either kill them or deliver cancer-killing substances to     them without harming normal cells. Giving GM-CSF together with rituximab after autologous     stem cell transplant may be an effective treatment for follicular non-Hodgkin lymphoma.      PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab after     autologous stem cell transplant works in treating patients with relapsed or primary     refractory follicular non-Hodgkin lymphoma.   "
204716|NCT00521053|"     The primary objective of this study is to investigate the effectiveness of intralesional (IL)     PV-10 for locoregional treatment of metastatic melanoma. This study will also include     assessment of response in untreated bystander lesions following intralesional injection of     PV-10 into targeted lesions. Additional objectives are to determine the safety profile of     PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in     the bloodstream following intralesional injection.   "
204717|NCT00521066|"     The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA* system in     women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.      (*TRADEMARK)   "
204718|NCT00521079|"     This is a randomized multi-center study being done to measure the ability of a new medical     device, Maestro System, to safely reduce body weight over five years in people who are     considered obese.   "
204719|NCT00521092|"     Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor. This phase II trial is studying the     side effects and how well sunitinib malate works in treating patients with Kaposi sarcoma.   "
204720|NCT00521105|"     The purpose of the study is to look at the effect of replacing the physician only visit by a     transmission of information on the participant's current diabetes management and blood     glucose monitoring results followed by a phone contact by the diabetes nurse educator. The     study will also measure the effect on diabetes control (HbA1c), satisfaction with care,     resource utilisation, and costs to the health care system and to the participant.      We hypothesize that replacement of the physician-only visit by a virtual visit will not     result in worsening of the medical outcomes and that it will result in a reduction in medical     resources utilization and costs for families while increasing the satisfaction with care.   "
204721|NCT00521118|"     This phase II trial studies how well a second curettage (removal of the abnormal cancer cells     in the uterus using a method of surgically removing the lining of the uterus) works in     treating patients with gestational trophoblastic tumors that did not go away after a first     curettage (persistent) and has not yet spread to other places in the body (non-metastatic). A     second curettage may be effective in treating persistent gestational trophoblastic tumors and     may decrease the likelihood that patients will need chemotherapy in the near future.   "
204722|NCT00521131|"     Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic     Rhinitis to House Dust Mites   "
204723|NCT00521144|"     This phase I/II trial is studying the side effects and best dose of obatoclax mesylate when     given together with topotecan hydrochloride and to see how well they work in treating     patients with relapsed or refractory small cell lung cancer or advanced solid tumors.     Obatoclax mesylate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving obatoclax mesylate together with topotecan hydrochloride may help     kill more tumor cells   "
204724|NCT00521157|"     The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants     as relapse prevention for patients that are completing treatment for opiate addiction in     inpatient (or similarly controlled) settings. Participants volunteer for the study before     being released from inpatient treatment, and are randomized to a naltrexone implant group or     a waiting-list control for the duration of the first six months following completion of     inpatient treatment. Both groups are free to receive treatment as usual (TAU) from the     Norwegian healthcare system. After six months, both groups will be offered to have naltrexone     implanted for the remaining six months of the study.      The hypotheses are that quality of life, depression, opioid use, will be significantly better     in the naltrexone group compared to the non at 6-month follow-up. For the last six months of     the trial, the investigators hypothesise that choice of naltrexone implant will mainly     strengthen positive tendencies or reverse negative trends on the aforementioned variables.      The investigators also hypothesize that the implants can prevent death from opioid overdose     up to 6 months after commenced treatment.   "
204725|NCT00521170|"     Compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal     and flare reaction.   "
204726|NCT00521183|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as     cytochlor and tetrahydrouridine, may make tumor cells more sensitive to radiation therapy.      PURPOSE: This phase I trial is studying the side effects and best dose of cytochlor when     given together with tetrahydrouridine and external-beam radiation therapy in treating     patients with cancer that has spread to the brain.   "
204727|NCT00521196|"     The purpose of this study is to determine whether a painless and noninvasive procedure called     Transcranial Direct Current Stimulation (tDCS) can be an effective therapy for the treatment     of migraine and migraine-associated pain.      Stimulation of the motor cortex with tDCS has already been shown to relieve pain in patients     with other chronic pain syndromes, including traumatic spinal cord injury and fibromyalgia.     Patients with migraine are usually extremely sensitive to pain. A treatment that targets the     areas of the brain that are related to the experience of pain may also help decrease pain in     patients with migraine. Pain control with this localized approach may help avoid the problems     due to pain medications that affect all organs in the body.      We hypothesize that 10 sessions of Transcranial Direct Current Stimulation (tDCS) applied     over the area of the brain that controls pain and motor function will decrease pain and     headache frequency in patients with migraine.   "
204728|NCT00521209|"     RATIONALE: Clinic-based health programs may be effective in improving the diets and physical     activity levels of low-income, uninsured participants in Los Angeles County, California.      PURPOSE: This randomized clinical trial is studying a patient-directed lifestyle change and     health promotion program to see how well it works compared with usual care in low-income,     uninsured participants in Los Angeles County, California.   "
204741|NCT00521391|"     Including a tailored moderate-intensity physical activity intervention in a standard smoking     cessation treatment program (pharmaceutical treatment and counseling) increases the chances     of quitting and reduces nicotine withdrawal symptoms, negative moods, stress, and weight     gain.   "
204884|NCT00536653|"     The aim of this study is to determine the long term effects of two types of hormonal     treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on     the bone mineral density of patients.   "
204729|NCT00521222|"     The investigators are conducting a study of asthma patients who use fluticasone with     salmeterol (Advair) or any other combination of an inhaled corticosteroid (ICS) and a long     acting beta agonist (LABA) to manage their asthma symptoms.      Participants begin the study by continuing to use fluticasone with salmeterol or substituting     fluticasone with salmeterol for their current ICS/LABA medication at their regular dose or     the comparable dose(all study medications are provided) for a six-week period. Patients are     then separated into 2 groups: one group is asked to use fluticasone (Flovent), the other to     use fluticasone with salmeterol , twice daily over a 16-week period (patients will need to be     seen monthly during this time). Neither study personnel nor patients will know which drug is     being used.      Patients are also asked to use a peak flow meter and record their daily results on a form,     along with the number of puffs they use of their rescue inhaler each day. They also record     any changes in asthma medications and information on any asthma episodes.      The investigators hypothesize that there are certain patients with asthma who will do better     when a long acting beta agonist is removed from their maintenance asthma medications.   "
204730|NCT00521235|"     The aim of the study is to validate the sanitary consequences of dental studies respectively     the longtime executed profession. In comparison to this cohort we will also check a     collective of subjects with an optimum of physical activity.   "
204731|NCT00521248|"     Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid     drugs prior to birth. Commonly used treatments at present include morphine or tincture of     opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been     used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual     (under the tongue) buprenorphine is able to be used safely and easily in newborns with the     neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine     is associated shorter stays in the hospital and fewer days of treatment than the use of     standard therapy. Another secondary goal will be to understand buprenorphine concentration in     the blood of babies treated with the drug (this is called pharmacokinetics).   "
204732|NCT00521261|"     RATIONALE: Giving high doses of chemotherapy before a donor stem cell transplant helps stop     the growth of cancer cells. It also stops the patient's immune system from rejecting the     donor's stem cells. Colony stimulating factors, such as aldesleukin and GM-CSF, may increase     the number of immune cells found in bone marrow or peripheral blood and may help the immune     system recover from the side effects of chemotherapy. The donated stem cells may replace the     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor     effect). Giving an infusion of the donor's T cells that have been treated with antibodies     after the transplant may help increase this effect. Sometimes the transplanted cells from a     donor can also make an immune response against the body's normal cells. Giving tacrolimus and     mycophenolate mofetil after transplant may stop this from happening.      PURPOSE: This phase I trial is studying the side effects and best dose of donor T cells given     together with low-dose aldesleukin and low-dose GM-CSF after donor stem cell transplant in     treating patients with relapsed or refractory non-Hodgkin's lymphoma.   "
204733|NCT00521274|"     The purpose of this study is to evaluate the role of combination therapy with Trovax plus     Docetaxel or Docetaxel alone in patients with prostate cancer with a rising prostate specific     antigen (PSA).   "
204734|NCT00521287|"     According to a survey from Department of Health in 2004, cancer has been the leading cause of     death in the Taiwan area. In 2004, people died of cancer, accounting for 27.2 percent of all     deaths. The major reason of the superior grade is that cancer has the ability to escape the     surveillance of immune system. It is also a main issue to address in medical research.      Dendritic cells (DCs), the most potent APC, are located at sites of pathogen entry, acquire     antigens from pathogens or pathogen-infected cells, and process these antigens for both class     I and class II presentation. Upon antigen encounter, they termed immature DCs, undergo a     maturation process, they are capable to present captured antigens to T cells. This maturation     step allows DC migration to trigger adaptive immune responses. These features make DCs very     good candidates for therapy against various pathological conditions including malignancies.      Therefore, two concepts in this project will be concerned: one is enhancement of T cell     immunity and the other is improvement of the efficiency of DC-tumor fusion. The strategy of     enhance T cell is using well-known cytokines, such as IL2, and IL7 to expand the     tumor-specific CD4 and CD8 T cells before DC-vaccine treatment. In the past, scientists     utilized polyethyleneglycol to fuse cancer cells and dendritic cells. However, the results     were devastating. Two new approaches of the DC vaccine will be applied to this study:     DC-tumor fusion and DC phagocytosed apoptosed tumor cells. Whole tumor cells will be fused     with DCs by combining hypotonic buffer and electrical-based fusion protocols. The safety of     hybrid cell vaccination has been shown in clinical trials with some encouraging anti-tumour     effects. However, data are as yet insufficient to assess a clear therapeutic benefit.     Hopefully, the combination of two strategies will improve the efficiency of DC vaccine and     boost survival of cancer patients.      As we have gained a clearer understanding of the cellular and molecular events that modulate     antigen presentation and T cell activation in vivo, new strategies have emerged, allowing the     development of more potent second generation DC vaccines.   "
204735|NCT00521300|"     The purpose of this study is to investigate whether 6 months preoperative treatment with the     somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.   "
204736|NCT00521326|"     The purpose of this study is to evaluate the feasibility of acquisition of coronary blood     flow velocity signals over the whole length of the LAD with transthoracic pulsed Doppler, and     to evaluate the diagnostic power of the transthoracic Doppler analysis package for detecting     and estimating the degree of coronary artery stenosis. Finally we hope to optimize the     currently available analysis package on the basis of the comparison of the Doppler with the     angiographic stenosis results and evaluation.   "
204737|NCT00521339|"     The study will test the safety and tolerability of Apremilast twice a day in participants     with recalcitrant plaque type psoriasis.   "
204738|NCT00521352|"     This study will evaluate the efficacy of 1-Hz rTMS applied to the right Dorsolateral     Prefrontal Cortex (DLPFC) in patients with Panic Disorder (PD) and comorbid Major Depressive     Disorder (MDD) who have not fully responded to conventional therapies.      The investigators hypothesize that:        1. compared to sham (placebo), active rTMS will improve symptoms of PD and MDD as assessed          with the Panic Disorder Severity Scale (PDSS), Hamilton Depression Rating Scale (HDRS),          and Clinical Global Impression (CGI);        2. active (but not sham) rTMS will normalize levels of motor cortex excitability relative          to pre-treatment baseline.   "
204739|NCT00521365|"     The primary purpose of the study is to assess the efficacy of Quetiapine extended release     600mg per day either as monotherapy or combined therapy in the treatment of patients with     mania associated to Bipolar disorder. This trial will also assess the life quality and     productivity loss improvement for patients from baseline to day 21.   "
204742|NCT00521404|"     Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to     subjects with previously untreated and unresectable (unable to be surgically removed) or     metastatic (spread to other areas beyond the pancreas) pancreatic cancer.   "
204743|NCT00521417|"     A primary goal of this study is to investigate the significance of treatment duration, by     comparing change after group psychotherapy of varying lengths. A secondary goal is to     investigate the predictive value of selected patient variables on outcome: personality     pathology, quality of object relations, presence of personality disorder, degree of initial     disturbance, and education. One hundred and twenty patients from 5-6 different study sites     (consisting of one coordinator and 3 therapists) will be included. Exclusion criteria are     psychosis, substance abuse, and organically based symptoms. Patients are interviewed before     treatment and one year after termination, and self-rated outcome measures are filled in at     3-month intervals during treatment and at termination. After an initial evaluation, patients     are randomized to one of two manualized psychodynamic group psychotherapies with different     treatment lengths (20 and 80 sessions). Each therapist will conduct both a short- and a     long-term group, and sessions are taped in order to check treatment integrity.   "
204744|NCT00521430|"     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of     cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the     donor's stem cells. When the healthy stem cells from a donor are infused into the patient     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,     and platelets. Sometimes the transplanted cells from a donor can make an immune response     against the body's normal cells. Giving cyclosporine and methotrexate before and after     transplant may stop this from happening.      PURPOSE: This clinical trial is studying the side effects and how well donor stem cell     transplant works when given after conditioning therapy in treating patients with hematologic     cancer, recurrent or metastatic solid tumor, or other disease.   "
204745|NCT00521443|"     Various morphological abnormalities of human oocytes were reported to detrimentally affect     embryo development. We observed development of frozen thawed embryos derived from oocytes     with normal or abnormal morphological features to the blastocyst stage. Cytoplasmic     abnormalities of the oocytes were found to negatively affect cryosurvival potential of the     embryos.   "
204746|NCT00521456|"     This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the     treatment of inflammation and pain associated with cataract surgery   "
204747|NCT00521469|"     To determine the effects of instrument-applied chiropractic manipulative therapy (CMT) on     postural control.   "
204748|NCT00521482|"     The aim of this study is to evaluate the efficacy and safety of intensive dose temozolomide     treatment alone in parallel to a combination with thalidomide in patients with recurrent     glioblastoma after standard therapy.      In the treatment arm A of the study it will be investigated whether or not continuous dosing     of temozolomide may overcome alkylator resistance in patients with glioblastoma who progress     on the 5/28 day dosing regimen.      For treatment arm B it is postulated that the combination of thalidomide and temozolomide is     effective with respect to time to progression and progression-free survival due to the fact     that temozolomide and thalidomide have different mechanisms of action.   "
204749|NCT00521495|"     The purpose of this Phase II study is to assess the feasibility of conducting a large scale     trial which will evaluate the effectiveness of static magnetic field therapy as a treatment     for Carpal Tunnel Syndrome. This preliminary study will determine which of three strength     magnets to use in the future.      Participants will be recruited from three primary sources. 1) Patients with a possible     diagnosis of Carpal Tunnel Syndrome who have been referred to the Orthopaedic and     Rehabilitation Clinics of OHSU for Nerve conduction studies. If after conducting these     studies a potential participant shows evidence of mild to moderate Carpal Tunnel Syndrome     s/he will be informed about the study and invited to participate in additional screening. B)     Patients seen at the National College of Natural Medicine (NCNM) Clinics who have a clinical     diagnosis of Carpal Tunnel Syndrome will be informed about the study and invited to enter the     screening process for further eligibility. C) Participants will also be recruited from the     general public including staff and students at OHSU and NCNM).      Eligibility will be determined through a stepwise process including telephone screening for     general eligibility, Nerve Conduction screening for electrodiagnostic eligibility, and Boston     Carpal Tunnel Questionnaire screening for symptom severity eligibility. Those potential     participants who meet all eligibility requirements will be randomized to one of three     magnetic field dosages. They will be provided with a ¾ diameter x 1/8 thick magnet which     they will be required to apply for six weeks during the hours of sleep. Over the course of     the study participants will have four visits to the General Clinical Research Center of OHSU     and three visits to the Orthopaedic and Rehabilitation Clinics of OHSU for Nerve Conduction     studies to be performed by either Dr. Nels Carlson or Dr. Hans Carlson.      Questionnaires to be completed during the course of the study include a general health     information and demographics questionnaire, the Boston Carpal Tunnel Questionnaire, which     will be completed on six occasions, a general symptoms checklist and a Post Treatment     Participant satisfaction questionnaire.      Recruitment, retention, compliance and safety will be analyzed using descriptive statistics.     Effectiveness of the three different strength magnets will be assessed by comparing     participants' baseline scores on the Boston Carpal Tunnel Questionnaire with their scores     after six weeks of magnet use.   "
204750|NCT00521508|"     Along structural IgA abnormalities, hyperproduction of IgA is thought to play a role in the     pathogenesis of primary IgA nephropathy. CD4+CD25+Fox3P regulatory T cells are instrumental     in suppressing adaptative immune responses, including B cells production of immunoglobulins.     We, the researchers at Centre Hospitalier Universitaire de Saine Etienne, will test the     hypothesis that IgA production in patients with IgA nephropathy is dysregulated because of a     quantitative and/or qualitative defect of CD4+CD25+FoxP3+ regulatory T cells.   "
204751|NCT00521521|"     To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or     without cisplatin in terms of objective response rates (WHO criteria).   "
204752|NCT00521534|"     Background and Introduction:      SDB is increasingly recognized as a co-morbidity with significant impact on overall health.     The disorder has been implicated in the development of hypertension, atherosclerotic     cardiovascular disease as well as arrhythmia, stroke and the progression of congestive heart     failure. The disorder is prevalent among males, estimated to affect upto 24% of the general     population. Its prevalence increases with age, and it is particularly prevalent among     patients with congestive heart failure with the prevalence rising to 51% in that group.     Interestingly, recent evidence points to a potential impact for treating sleep disordered     breathing, on heart failure patients. At the same time, recent reports of a beneficial impact     of atrial overdrive pacing on SDB, have stirred interest in a potentially effective and well     tolerated non-pharmacologic means of therapy for this disorder. Particularly at a time when     cardiac resynchronization therapy utilizing biventricular pacing has demonstrated significant     impact on heart failure, the interplay between CHF and SDB pacemaker based therapy begs     further exploration. The interdependence of potential positive impact on each entity needs to     be elucidated for further research and refinement of therapeutic tools. Furthermore, this     study aims to explore potential neurohormonal influence on and affection by each of these     disorders.      Specific Aims and Hypotheses:      Specific Aim #1: To assess the effect of cardiac resynchronization therapy (CRT) with or     without atrial pacing on SDB in patients with advanced CHF at 8 and 16 weeks after     implementation of therapy.      Hypothesis #1: Resynchronization therapy improves SDB, the effect may anticipate or lag     improvement in heart failure. Atrial pacing has a beneficial effect in addition to CRT.      Specific Aim #2: To explore the effect of CRT on cardiac neuro-hormonal activity in relation     to its effects on CHF and SDB.      Hypothesis #2: CRT neuro-hormonal modulation is a common path in its effects on SDB and CHF.      Specific Aim #3: To assess prevalence of sleep disordered breathing (SDB) in patients with     advanced congestive heart failure (CHF).      Hypothesis #3: SDB is prevalent yet under recognized in this patient population.      Research Design:      This is an observational study with a built in double blinded prospective randomized     interventional substudy of a potential confounder i.e. atrial pacing. All patients will     receive CRT with defibrillator for clinical indications (CRT-D). Investigators other than the     EP physicians as well as patients will be blinded to the pacing mode. After screening and a     run in period of back up pacing a baseline polysomnogram (PSG) will be performed. Patients     will be randomized between atrial overdrive or atrial tracking pacing modes for six months,     all patients receiving CRT. Sleep studies will be performed at baseline and at three month     intervals. Subjects: Patients referred for implantation of CRT -D will be recruited for this     trial. Patients are included only if they are indicated for such a device on clinical     grounds. Outcome Measures: 1.Sleep quality related Parameters:The following will be collected     at times of each PSG: MAP-PSQI, PSG parameters of sleep quality and architecture, apnea     hypopnea index, and oxygen saturation as well as biochemical markers of sleep efficiency.     2.Heart Failure Parameters: The following will be obtained at times of each PSG: Minnesota     Living with Heart Failure Questionnaire, Clinical and echocardiographic measures of heart     failure progression and biochemical markers of heart failure severity.      Power Analysis: An improvement in SDB in both initial randomization arms is assumed, however     we further assume the atrial overdrive arm will offer improvement over the atrial tracking     arm of equal magnitude. An arbitrary estimate would be twenty percent improvement in atrial     overdrive arm. The corresponding estimate is 40% improvement due to CRT. To achieve 0.80     power thirty four data sets need to be collected.   "
204753|NCT00521547|"     Acupuncture may affect nerve functions. This study assesses the effect of acupuncture on both     the peripheral and the central nerve systems   "
204754|NCT00521560|"     Phase II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy with simultaneous     application of Zevalin and BEAM followed by autologous peripheral stem cell transplantation     in relapsed and refractory CD 20+ Non-Hodgkin's lymphoma   "
204755|NCT00521573|"     The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark     chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in     heart transplanted patients.   "
204756|NCT00521586|"     This study is to evaluate the safety, tolerability and immune response when 13-valent     pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are     given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal     polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also     evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of     13vPnC given 5 years after the first dose.   "
217948|NCT00704353|"     The objective of this study is to evaluate the safety of FCM in patients with anemia who are     not dialysis dependent   "
204757|NCT00521599|"     This study is a placebo-controlled study with 8-weeks of double-blind treatment of mometasone     furoate dry powder inhaler (MF DPI) 200 mcg twice daily (BID) using two different inhalers,     preceded by the Screening Period and by 2 weeks of open-label treatment with one inhalation     of MF DPI 200 mcg twice daily in corticosteroid-dependent asthmatic subjects. The objective     of this study is to evaluate the therapeutic equivalency of the 100 mcg and 200 mcg MF DPIs     when providing the same total daily dose (400 mcg/day).   "
204758|NCT00521612|"     Two groups of patients are going to have abdominal surgery with low-flow general anaesthesia.     Group A (sevoflurane group, experimental group) will use volatile anaesthetic sevoflurane.     Group B (isoflurane group, control group) will use volatile anaesthetic isoflurane. It will     be observed differences between volatile anaesthetic sevoflurane and volatile anaesthetic     isoflurane for providing low-flow general anaesthesia for abdominal surgery. Duration of this     randomised controled trial will be approximately 2 months. Estimated sample size will be 82     persons (41 in sevoflurane group and 41 in isoflurane group).   "
204759|NCT00521625|"     PALIVE 1 is an observational multicenter study on mechanical ventilation strategies used in     children with an acute lung injury (ALI). The objective of the study is to describe     mechanical ventilation strategies in children with an ALI. Our hypothesis is that daily     clinical practice is heterogenous among pediatric intensivists as few pediatric data exists     on optimal mechanical ventilation strategies in this group of patients. Furthermore,     different strategies may affect patient outcome.   "
204760|NCT00521638|"     This is a study to evaluate the safety and efficacy of TRU-015 in treatment of B-cell     Non-Hodgkin's Lymphoma (NHL).      TRU-015 is also currently being evaluated in multiple clinical studies for the treatment of     autoimmune disorders. Over 300 patients have received TRU-015 in these studies, and the data     observed to date support its safety in patients with autoimmune disorders.      Safety of an escalating dose of 4 weekly infusions of TRU-015 will be evaluated in subjects     with relapsed NHL (see inclusion criteria for subtypes).      Once a maximum tolerated dose (MTD) is confirmed or maximum dose to be studied is determined     to be safe and well tolerated, an expanded cohort of subjects with relapsed follicular NHL     will be evaluated for efficacy.   "
204761|NCT00521651|"     This protocol is a sub-study of the ongoing Protect Health and Reduce Cancer Risk study     conducted in Shanghai, China, and sponsored by the Shanghai Cancer Institute, Vanderbilt     University, and the National Cancer Institute. The parent study is designed to examine the     relationship of diet, lifestyle, occupational, and environmental risk factors, as well as     genetic variation, to cancer incidence in a large cohort of men in women between 40 and 70     years of age. The current sub-study will assess the validity and reliability of a new     physical activity questionnaire for use in the parent study and to evaluate whether different     types of activity and the frequency, intensity, and duration of activity are associated with     markers that have been linked to cancer risk, such as C-reactive protein, interleukin 6 and     soluble tumor necrosis factor alpha.      Participants in the current 12-month study are selected from among men and women     participating in the Protect Health and Reduce Cancer Risk study. Participants keep a diary     of their physical activity and complete two 30-minute interviews about their physical     activity, one at the beginning and one at the end of the study period. Every 3 months for 7     consecutive days, they wear a pager-sized activity monitor on their waist that records their     physical activity patterns during that period of time. They provide blood and urine samples     four times during the study and, at the end of the study, undergo a health examination that     includes an electrocardiogram, body composition measurement, and physical fitness test. The     fitness test is a step-test consisting of 3-minute stages in which the subject successively     increases the stepping speed until reaching 85 percent of his or her predicted maximal heart     rate.      Blood and urine samples are analyzed for levels of nutrients and certain proteins, and are     stored for future studies related to nutrition and physical activity and possibly for genetic     studies related to health, nutrition, exercise, or disease.   "
204762|NCT00521664|"     The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e.     platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions     compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without     any sign of bleeding when the platelet count is below 10.000/µL). With the experimental     transfusion strategy transfusions could be safely reduced when the study hypothesis can be     proven. This is the first prospective randomized study on this topic.   "
204763|NCT00521677|"     Patients on ventilator are in high risk to develop ventilator associated pneumonia (VAP).     This acquired infection significantly increases morbidity and mortality of these patients.      Studies that investigated the factors influencing the incidence of VAP proved that infectious     agents located in the throat and oral cavity are important factors.      The assimilation of oral cavity treatment, including teeth brushing, cleaning and removal of     secretions may significantly decrease the incidence of VAP. Choosing the method of oral     cavity cleaning is based on few studies that demonstrated the optimal influence of combining     mechanical cleansing, the use of a non alcoholic antiseptic material and lubrication of the     lips and the oral cavity. Most of these studies are retrospective. The study will compare the     traditional method of oral cavity treatment with the use of protocol that use special suction     connected toothbrush to clean the teeth and the oral cavity, use of non alcoholic antiseptic     solution and lubrication of the lips and the oral cavity.      The current study is a prospective, open label, statistically balanced study that will     investigate the connection between the method of oral cavity treatment and the incidence of     VAP. 100 patients will be included.      All ventilated patients in the ICU will be eligible and will be included after an informed     consent will be signed by the patient, or by his legal guardian. Exclusion criteria include     age less than 18 y/o, pregnancy, expected survival of less than 48 hours, immunosupression     (excluding patients on steroids), severe burns, existing pneumonia and patient already     included in another study.      The main outcome will be 30 days all cause mortality. Secondary outcomes include the     development of VAP, days on ventilator, LOS in the ICU and LOS in the hospital.   "
204764|NCT00521690|"     The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin     detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD     with/without once-daily NPH Insulin treatment.   "
204776|NCT00521846|"     The purpose of this prospective clinical data collection is to document the performance and     clinical outcomes of the ExploR Modular Radial Head.   "
204777|NCT00521859|"     Primary:      Define the maximal tolerated dose (MTD) of VNP40401M when given with hematopoietic cell     transplantation (HCT)      Secondary:        -  Describe the change in pharmacokinetic (PK) parameters with increasing doses of drug.        -  Describe and estimate the frequency of > Grade 3 non-hematologic/non-infectious          toxicities at the MTD.        -  Report the efficacy of the regimen.        -  Evaluate the rate of engraftment for the regimen.   "
217949|NCT00704366|"     This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients     with advanced solid malignancies.   "
204765|NCT00521703|"     There is some controversy in the medical literature regarding the effectiveness of topical     lidocaine in children as an adjuvant drug to upper gastrointestinal endoscopy. In children,     deep sedation and general anesthesia are often used to sedate children submitting to this     procedure. Propofol is an anesthetic drug increasingly popular in this situation, but this     drug can only be used with an anesthesiologist in Brazil. Its main side effects include     hypotension, respiratory depression and local pain. Lidocaine is frequently used as     premedication, and the rationale is that lowering patient discomfort could lower the required     dose to achieve the endoscopy and reduce potential side effects. Nevertheless, some patients     perceive this medication as uncomfortable. This study aims to compare sedative drug doses     between patients who were given either placebo or topical lidocaine.   "
204766|NCT00521716|"     The purpose of this study is to determine the safety and efficacy of using WaisFix100i device     for Intracapsular Femoral Fracture Fixation.   "
204767|NCT00521729|"     This study will examine how body metabolism adjusts to small changes in environmental     temperature and how it may be related to weight loss.      Healthy, non-obese individuals between 18 and 60 years of age may be eligible for this study.     The study consists of one screening visit and one 5-day admission to the NIH Clinical Center     for the following procedures:      Diet: Participants follow a proscribed diet consisting of 50% carbohydrates, 20% protein and     30% fat.      DEXA scan to measure body fat. Subjects lie on a table above a source of X-rays while a very     small dose of X-rays is passed through the body.      Air displacement plethysmography (Bod-Pod) to study fat composition: Subjects sit in a small     booth for 10 minutes wearing a swim suit and breathing normally through a tube. This test     measures the person s weight and volume precisely.      Metabolic room: Subjects stay 12 hours in a specialized room designed to measure the amount     of oxygen breathed in and the amount of carbon dioxide breathed out. The room contains a     private toilet and sink, treadmill, bed, desk, window, telephone and computer with television     and internet access. While in this room, subjects undergo the following:        -  Continuous heart rate monitor: Subjects wear an EKG monitor to analyze heart rate          variability.        -  Spontaneous movements: Subjects wear portable accelerometers at the hip and wrist to          measure spontaneous physical movements.        -  Continuous temperature monitor: Subjects swallow a small capsule that transmits internal          body temperature via miniature, wireless sensors. Adhesive patches placed on the skin          monitor external body temperature.        -  Blood and urine collections: Subjects collect all of their urine during the 12 hours          they are in the metabolic room. Blood samples are taken at specified intervals through a          catheter that has been placed in a vein.        -  Microdialysis: A small needle is placed into fat tissue just under the skin on the          abdomen. A solution containing a minimal amount of ethanol is infused and samples of          fluid are collected every 20 minutes as it leaves the fat pad. This helps determine the          metabolism level. This procedure starts 30 minutes before entering the metabolic room          and continues until the subject leaves the room.      Fat tissue biopsy: A small piece of fat tissue is withdrawn through a needle from under the     skin on the abdomen. The sample is used to study fat tissue size and ability to store sugar.   "
204768|NCT00521742|"     The purpose of this study is to evaluate the cardiovascular effects of pioglitazone, once     daily (QD), versus glyburide when administered to patients with type 2 diabetes mellitus and     mild cardiac disease.   "
204769|NCT00521755|"     The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB     system for soft tissue bonding.   "
204770|NCT00521768|"     Introduction: Efforts to bridge the gap between research based treatment modalities     advancements and clinical practice have received the highest priority in the research     community. In the child psychiatry field there is an urging need to promote bridging this     gap.      Parents and child health providers hesitate to refer children to child psychiatrist due to     stigma but also due to lack of awareness of available and efficient treatment options. In the     field of trauma treatment another reason for lack of treatment is lack of recognition of     trauma related symptoms in children.      After the second Lebanon war scarce referrals to psychiatric clinics have been registered and     access to treatment is low as indicated by 20 referrals in the past year to Emek Hospital.      We propose to explore the effectiveness of well-established adult treatment for PTSD, the     Prolonged Exposure (PE), in community-based general pediatric clinics, serving an     underprivileged diverse population.      Methods:      Twenty children age 6 to 18 attending general pediatric clinic and in Afula region will     included.      children will be diagnosed using the Hebrew translation of the Childhood version of the     Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989 Children will receive     the Children's Depression Inventory (CDI) and the. CPSS All subjects will be treated with a     manualized 12-week Prolonged Exposure protocol Ratings will be made at baseline, 6weeks, and     12 weeks using CDI and CPSS      Hypothesis:      1. PE adapted for pediatric population will be effective in treating single-event traumas in     a community setting.   "
204771|NCT00521781|"     The purpose of the clinical trial is to assess the clinical benefit as measured by time to     tumor progression of Abraxane plus hormonal therapy when applied to previously untreated     patients with unresectable or metastatic adenocarcinoma of the prostate, as well as to assess     safety and tolerability of the study drug regimen and to evaluate secondary efficacy     endpoints such as overall survival and duration of response.   "
204772|NCT00521794|"     Andersen-Tawil Syndrome (ATS) is a rare, genetic disorder that causes episodes of muscle     weakness, potentially life-threatening changes in heart rhythm, and developmental     abnormalities. Disease symptoms can vary, the cause of some ATS cases remains unknown, and no     specific treatment has been identified. The purpose of this multi-site study is to better     characterize ATS, establish whether symptoms change over time, and determine if symptoms are     related to a mutation in the KCNJ2 gene.   "
204773|NCT00521807|"     Objective: The study was performed to evaluate the effect of a standardized hypnosis     treatment used in general practice for patients with chronic widespread pain (CWP).      Design: A randomized control group-controlled study. Setting and subjects: 16 patients were     randomized into a treatment group or a control group, each constituting eight patients. Seven     patients in the treatment group completed the schedule. After the control period, five of the     patients in the control group also received treatment, making a total of 12 patients having     completed the treatment sessions.      Intervention: The intervention group went through a standardized hypnosis treatment with ten     consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on     ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy.      Main outcome measures: A questionnaire was developed in order to calibrate the symptoms     before and after the 10 weeks period, and the results were interpolated into a scale from 0     to 100, increasing numbers representing increasing suffering.   "
204774|NCT00521820|"     The purpose of this study is to compare the safety of Pioglitazone, once daily (QD), to     Glyburide in Type 2 Diabetes Subjects with Mild to Moderate Congestive Heart Failure   "
204775|NCT00521833|"     To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and     intraocular lens implantation using temporal versus nasal clear corneal incisions.   "
204779|NCT00521885|"     A total of 50 patients >40 yrs of age with an expected hospital stay in the Medical Intensive     Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The     patient and study team will be blinded to which drug they are receiving (either Arixtra or     Lovenox). Subjects will be examined for any bleeding complications. Subjects will receive     drug for a total of 6-14 days while in the hospital. A follow up phone call will be performed     by the study team approximately 30 days after discharge from the hospital.   "
204780|NCT00521898|"     To evaluate isolated Descemet membrane transplantation as a refinement of previous advanced     techniques for corneal transplantation, like Descemet Stripping Endothelial Keratoplasty     (DSEK)   "
204781|NCT00521911|"     Depression is a common disorder among patients with a somatic illness admitted to the general     hospital. Patients with depression do worse in terms of their somatic symptoms or functioning     that those without depression. They also stay in the hospital for longer.      That is the reason that we are interested to know whether patients with depression do better     if their depression is recognised earlier and treated appropriately. We would like to find     out which questionnaires are most suitable in clinical practice to help pick up patients with     a depression. In addition, we would like to know whether a short-term psychological treatment     of depression would be of any help. We hope to be able to show that this treatment would not     only result in a reduction of depressive symptoms, but also in a better and quicker recovery     of the somatic illness.      The treatment will consist of 6 to 9 weekly sessions of one hour, conducted by a cognitive     behavioural assistant. Initially, the treatment will take place in the hospital. When     patients are discharged, treatment sessions will continue at home. The treatment will focus     on things like recognising and challenging unhelpful thoughts, planning of activities, and     testing out of predictions by setting up behavioural experiments. Three monthly booster     sessions will be offered to help patients to maintain their gains and prevent relapse. We     will reassess the symptoms of the patients at three and six months after the end of     treatment.   "
204782|NCT00521924|"     This Phase 3, randomized, open-label, multicenter study in rheumatoid arthritis (RA) patients     with low disease activity (Disease Activity Score 28 [DAS28] >2.8 and <3.5) is being     conducted to evaluate induction of remission by adding infliximab to pre-existing treatment     versus no additional treatment. All subjects eligible for this study, aged >35 to <=65 years,     will have a diagnosis of RA according to American College of Rheumatology (ACR) criteria, and     will be offered additional treatment with infliximab. Prior to the start of treatment,     subjects must be on a stable regimen of disease modifying antirheumatic drugs (DMARDs) for at     least 3 months. Subjects will be randomized (1:1) to basic therapy with or without infliximab     for a total duration of 38 weeks followed by a follow-up period of up to 6 months. Subjects     randomized to basic therapy + infliximab will receive infliximab 3 mg/kg at Weeks 0, 2, 6,     14, 22, 30, and 38. The primary objective of the study is to assess the rate of remission     according to DAS 28 (<2.6) at the end of treatment (after 38 weeks). Safety assessments     include the incidence of adverse events, serious adverse events, and clinically notable     abnormal vital signs and laboratory values.   "
204783|NCT00521937|"     It is estimated that 300 million people worldwide will have diabetes by the year 2025. About     12 percent of those with diabetes will have had a foot ulcer, which is a major source of     morbidity, concern, and cost.      The foot ulcers are the leading cause of hospitalization among people with diabetes and often     lead to amputation. The costs of treatment and the high morbidity and mortality associated     with diabetic foot problems necessitate the need for a systemic approach to a foot ulcer     management.      Current local treatments of this type of ulcer are: dressings (hydrocolloids, alginate…), and     growth factors. However modern dressings may not avoid infection and the results of the     clinical studies are not significant in terms of complete healing rate or in terms of time to     healing. Concerning growth factors, the only one whose therapeutic application made proof is     the rhPDGF (Regranex®) with an increase in the number of ulcers completely healed at the     twentieth week compared to placebo (50% and 35%, respectively).      The advancement of tissue-engineering has made possible dermal replacement on human wounds to     facilitate healing.      A new sponge composed of collagen and glycosaminoglycans (chondroitins 4 and 6 sulphate),     reticulated by ionic bonds with chitosan before freeze-drying, was developed in France. This     sponge is a non-toxic product due to its non-chemical reticulation (ionic bonds),     biocompatible and biodegradable processes, handling and storable easily.      The objective of this study is to demonstrate that such a substitute, cellularized by     functional allogenic fibroblasts, and complying with all safety conditions, enables to lead     to healing of diabetic foot ulcers.   "
204784|NCT00521950|"     The purpose of this study is to determine whether thiopurine S-methyltransferase (TPMT)     genotyping prior to thiopurine use is cost-effective in patients with inflammatory bowel     disease (IBD) in need of immune suppression.      The study is designed to test the hypothesis that optimization of initial thiopurine dose     based on pre-treatment TPMT genotyping will maximize treatment efficacy and minimize adverse     drug reactions (ADRs) resulting in reduced costs.   "
204796|NCT00522106|"     We performed a randomized controlled trial to study the effectiveness of Behavioral graded     activity (BGA) in patients with OA of the hip or knee. It was hypothesised that in the long     term BGA results in less pain, less limitations in activities, and better patient global     assessment (i.e. the effect of treatment perceived by patients themselves), compared to usual     care of physiotherapists (UC). UC was operationalized as physiotherapeutic care according to     the Dutch physiotherapy guideline for patients with hip and/or knee OA. It was also     investigated whether specific subgroups of patients benefited more from BGA and which factors     influenced the success of BGA-treatment. Also, it will be investigated whether differences     exist in exercise adherence and whether there is a relationship between exercise adherence     and long-term effectiveness.   "
204797|NCT00522119|"     High blood pressure affects nearly one third of all individuals in the United States. It is     believed that genetic factors may predispose some people to develop this disease. This study     will identify and characterize variations in three genes known to play a part in the     development of high blood pressure.   "
204799|NCT00522145|"     The purpose of this study is to determine the best confirmed response rate of daily     administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and     VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with     either erlotinib or gefitinib.   "
204785|NCT00521963|"     Intra-articular (IA) injection of medication is a common procedure in the management of joint     disorders. In particular, the procedure is effective in the treatment of inflammatory     conditions, with long acting corticosteroids most commonly used. These agents have been shown     to reduce the signs and symptoms of inflammation, expressed primarily in the synovium of the     joint, and are probably capable of slowing the progression of damage to joint cartilage and     bone in some of these inflammatory conditions. Arthritis that is refractory to IA     corticosteroid injections may respond to surgical, chemical, or, radioisotope synovectomy,     procedures in which the inflamed synovial tissue is eradicated. It has been noted that     infliximab, a monoclonal antibody directed to Tumor Necrosis Factor (TNF) - α, has high     affinity for the TNF-α rich inflamed synovium. Recently, clinical benefit from IA injections     of infliximab has been reported in some cases that were refractory to IA injections of     corticosteroids. Similarly, the effectiveness of IA infliximab in suppression of joint     inflammation has also been demonstrated in patients who could not receive systemic therapy     with infliximab. These reports examined the effect of a single injection of infliximab100 mg     injected into a large inflamed joint or 2 IA injections 24 hours apart.      We propose to further evaluate the use of IA infliximab in patients with intractable knee     monoarthritis, explore the optimal mode of its employment, and assess the degree of     infliximab systemic absorption from the IA injection. In a pilot study 40 knees will be     evaluated, 20 injected with infliximab and 20 injected with a corticosteroid comparator     reflecting the current standard of care.   "
204786|NCT00521976|"     The main aim of this trial is to assess the long-term prognostic value of different types of     Factor XIIa in an unselected, single center series of 871 chest pain patients admitted to the     emergency unit, employing blood samples collected at admission.      The second purpose of this study is to assess the incremental prognostic value of B-type     natriuretic peptide (BNP) and high-sensitive C-reactive protein (hsCRP).      A third purpose of this study is to evaluate the prognostic impact of the Omega-3 Index which     is a measure of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to other     fatty acids in the erythrocyte membrane.   "
204787|NCT00521989|"     CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug     dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to     work through a novel mechanism of action in which dipyridamole selectively amplifies the     anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating     the dose-dependent adverse effects.      CRx-102 has been associated with clinical benefit in proof of concept studies in subjects     with hand OA and RA. This is the first study to explore the efficacy of CRx-102 in knee OA.     It is considered a dose-finding study and will also compare the potential benefits of CRx-102     treatment to both prednisolone administered alone and to placebo in this indication.   "
204788|NCT00522002|"     To explore the hypothesis that leg ulcers are associated with hypercoagulable states, the     CLUE study will evaluate patients with connective tissue disease associated leg ulcers, to     identify risk factors (especially hypercoagulability and immunologic characteristics),     characterize pathogenesis, predict response to therapy, and assess the impact of lower     extremity ulcers on quality of life.   "
204789|NCT00522015|"     to show that        1. patients improve and stabilize after 12 -24 week treatment with rivastigmine in memory          function        2. use of rivastigmine has a positive effect on apathy in PSP patients        3. therapy with rivastigmine has a no positive benefit on speech and overall results of the          MMST        4. changes in motor activity are associated with changes in language and overall results of          the in MMST   "
204790|NCT00522028|"     The present study is a randomized, controlled trial that investigates the effects of     parathyroidectomy or medical observation in mild asymptomatic pHPT on morbidity and quality     of life (QoL).   "
204791|NCT00522041|"     Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal     pain especially during defecation and for 1 or 2 hours afterwards. There are no approved     drugs in the United States (US) for this condition and surgery is often the treatment choice.     Strakan is conducting this confirmatory study so the product can be submitted for regulatory     approval in the US. Strakan currently markets this product throughout Europe.      The objective of this study is to determine the effect of nitroglycerin ointment 0.4%     (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21     days of treatment in 250 patients.   "
204792|NCT00522054|"     The purpose of this study was to study the impact of Tai Chi group exercise on physical     function, health and disease activity of patients with RA, and to examine the patients'     experience and perception of Tai Chi.   "
204793|NCT00522067|"     This phase II, open label, is designed as a seasonal study to support annual strain update     evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation     of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic     diseases   "
204794|NCT00522080|"     Objective: To study the feasibility and validity of a two-step telephone screening procedure     for symptomatic knee and hip osteoarthritis (OA) in the general population.      Method: The screening questionnaire was based on signs and symptoms, previous diagnosis of     OA, and validated OA criteria. A random sample of telephone numbers was obtained and, at each     number, one individual aged 40 to 75 years was included. A physical examination and knee or     hip radiographs were offered when the screen was positive. A sample of individuals with     negative screens was also examined. The diagnosis of hip/knee OA was based on either American     College of Rheumatology criteria for signs and symptoms and Kellgren-Lawrence radiographic     stage 2 or greater. Prevalence rates were estimated with correction for the performance of     the screening procedure.   "
204795|NCT00522093|"     TJ-100, a Japanese herbal medicine, is clinically effective in postoperative ileus. So it may     activate bowel movement. This study will test the efficacy and safety of TJ-100 in the     treatment of patients with chronic constipation.   "
204798|NCT00522132|"     The primary objective of the study is to evaluate the effectiveness of 2 intravenous     artesunate dosing regimens (2.4 mg/kg initially and at 12, 24, 48, and 72 hours or 4.0 mg/kg     initially and at 24 and 48 hours) in clearing P. falciparum parasites in children with severe     malaria.      Secondary objectives include:        -  To compare the tolerability and safety of the 2 intravenous artesunate dosing regimens.        -  To evaluate differences in the pharmacokinetic profile of intravenous artesunate by          patient age and clinical presentation.   "
204802|NCT00522184|"     Intra-articular injection of etanercept in patient suffering from rheumatoid arthritis: a     double-blind randomized study for evaluation of efficacy and safety of etanercept versus     intra-articular steroid injection in acute synovitis (knee,wrist,ankle,elbow)   "
204803|NCT00522197|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of ACAPHA, a combination of six herbs, may prevent lung cancer from forming in former smokers     with bronchial intraepithelial neoplasia.      PURPOSE: This randomized phase II trial is studying the side effects and how well ACAPHA     works in preventing lung cancer in former smokers with bronchial intraepithelial neoplasia.   "
204804|NCT00522210|"     The purpose of this study is to determine whether there is a difference in blood sugar     control (as measured by hemoglobin A1c (HA1c)), in children given twice daily insulin     injections incorporating a new long acting insulin analogue (detemir) compared to children     using their current three times a day insulin injections (with intermediate and rapid acting     insulin).   "
204805|NCT00522223|"     Primary Objectives:        1. To assess the entire range of sexual functioning (desire, arousal, orgasmic capacity,          dyspareunia, and sexual satisfaction) over the course of treatment and early follow-up          in patients with local and locally advanced cervical cancer;        2. To assess general cancer-related QOL over the course of treatment and early follow-up in          patients with local and locally advanced cervical cancer;        3. To characterize the relationship between sexual dysfunction and overall cancer-related          QOL over time; and        4. To identify factors that may predict better sexual function outcomes in patients treated          for cervical cancer.      Secondary Objectives:        1. Describe vaginal changes objectively via measurement of vaginal length.        2. Demonstrate reliability of the vaginal length instrument and its applicability to future          studies.   "
204806|NCT00522236|"     To evaluate the antibody response to each influenza vaccine antigen when administering a     single dose to subjects aged 65 years and over   "
204807|NCT00522249|"     The purpose of this study is to evaluate the combination of Pegylated Alfa Interferon     (PEG-Intron), Sunitinib and Tarceva to see if this drug combination delays the disease     progression of patients with metastatic Renal Cell Carcinoma. The first phase of this study     will determine the best dose of Peg-Intron, Sunitinib and Tarceva when given in combination.     The safety of giving these drugs in combination and response to treatment will also be     examined.   "
204808|NCT00522262|"     The purpose of the ALPHA Trial is to examine the physiologic changes that occur in a woman's     body when she begins exercising that may be related to a change in her risk of getting breast     cancer.   "
204809|NCT00522275|"     The purpose of this trial is to determine whether lacosamide is safe and effective for     long-term use in patients with partial-seizures from epilepsy   "
204810|NCT00522288|"     The purpose of the study is to determine whether contact lens wear will improve children's     self-perceptions more than spectacle wear.   "
204811|NCT00522301|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with     ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer in at least the second     remission.   "
204812|NCT00522314|"     This clinical trial is investigating the efficacy of Non Invasive Ventilation (NIV) as a     method of airway clearance in patients with an acute exacerbation and moderate to severe     bronchiectasis disease. Current treatment focuses on the use of Active Cycle of Breathing     Techniques (ACBT) but this modality alone may not be sufficient when patients have more     severe disease and an acute infection. The use of NIV may result in better patient care and     more appropriate physiotherapy treatment in the more unwell population.The aim of this study     is to compare the efficacy of two physiotherapy airways clearance interventions in     bronchiectasis.   "
204813|NCT00522327|"     All new patients to the general medicine clinic who were not primarily English speaking were     randomized, after consenting, to receieve either remote simultaneous medical interpreting or     usual and customary interpreting services. Patient charts were followed for one year after     enrollment to assess medical outcomes, including patient satisfaction, diabetes management,     lipid management, depression screening and management, vaccine administration.      All Spanish-speaking ER patients were similarly enrolled. They were followed for one ER visit     and their knowledge of exit instructions was assessed, as well as their satisfaction with     care.   "
204814|NCT00522340|"     An implantable cardioverter-defibrillator (ICD) is a small device that is surgically     implanted in the chest or abdomen and uses electrical pulses or shocks to help control     life-threatening, irregular heartbeats. Increasing aerobic exercise may provide health     benefits to people with ICDs. This study will examine the effects of an exercise program on     heart and lung function in people who have an ICD.   "
204815|NCT00522353|"     The purpose of this study is to determine if oligofructose supplementation promotes weight     loss in overweight and obese adults.   "
204816|NCT00522379|"     The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine     used with L-dopa in treating advanced stage Parkinson's disease.   "
204817|NCT00522392|"     This randomized phase III trial compares bortezomib, dexamethasone, and lenalidomide with     bortezomib and dexamethasone to see how well they work in treating patients with multiple     myeloma previously treated with dexamethasone. Bortezomib may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in     different ways and stop cancer cells from growing. It is not yet known whether giving     bortezomib and dexamethasone is more effective with or without lenalidomide in treating     multiple myeloma.   "
204839|NCT00532740|"     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near     a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be     effective treatment for liver cancer that cannot be removed by surgery.      PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating     patients with metastatic liver cancer that cannot be removed by surgery.   "
204840|NCT00532753|"     The Hunger Project/Epicenter strategy is a community based development strategy that will     positively affect health, education, empowerment, and consumption.   "
204818|NCT00522405|"     Background Hepatocellular carcinoma, a malignant tumor of liver is one of the most common     cancers worldwide. All India Institute Of Medical Sciences (AIIMS) being a tertiary care     hospital receives about two to three cases of Hepatocellular carcinoma (HCC) each day in our     Gastroenterology out patient department. Most of these patients present late when the disease     is already advanced and no curative therapies can be offered. At this stage, palliative     therapy forms the mainstay of treatment. This includes TACE or Oral chemotherapy. Whether     oral chemotherapy administered along with TACE potentiates the effect and further prolongs     survival, needs to be ascertained. No studies of this kind are available.      This prospective study is therefore designed to address this issue.   "
204819|NCT00522418|"     This is a post-market medical device study. This study will compare best medical practice     with or without adjunctive VNS Therapy in patients who are 16 years and older with     pharmacoresistant partial epilepsy.   "
204820|NCT00522431|"     Low testosterone is a condition that occurs when the body is unable to produce sufficient     quantities of testosterone. The medical name for low testosterone is hypogonadism.     Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of     energy and mood swings. The goal of testosterone replacement therapy is to return     testosterone levels to the normal range and relieve symptoms.      The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to     maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18     to 75 years. This will be determined by blood sampling at specified times during the study.     The study is also intended to evaluate the tolerability of Fortigel, which will be applied to     the skin each day throughout the study period.   "
204821|NCT00522444|"     Nebulized Magnesium Sulfate has been shown to be of benefit in adults with acute asthma     exacerbations, though limited work has been done in the pediatric population. Current     therapeutic questions include the effect of more than one dose of nebulized magnesium, the     possibility of a sustained effect (greater than 20 minutes) after a treatment, the potential     benefit in children younger than 5 years of age, and the use of an asthma score to re-assess     patients after treatment with this medication. The purpose of this double-blind randomized     placebo-controlled clinical trial is the evaluate the effect of multiple doses of nebulized     magnesium sulfate versus saline in addition to standard asthma therapy on clinical asthma     score and FEV1 in children 7 to 18 years of age with a moderate to severe acute asthma     exacerbation. Our hypothesis is that nebulized magnesium sulfate, when added to traditional     bronchodilator therapy, will improve acute asthma exacerbations more rapidly than standard     therapy alone. The primary outcomes are asthma score and FEV1 values obtained after two     nebulized magnesium sulfate compared to placebo treatments. This therapy will be supplemental     to standard therapy of albuterol and ipratropium nebulized treatments and systemic     corticosteroids. The secondary outcome is patient disposition (discharge home or     hospitalization). Patients with known asthma will be approached for enrollment and informed     consent obtained if the asthma score after the first albuterol treatment is 2 or greater.     One hundred-seventy patients will be enrolled and randomized to either the treatment group or     the placebo group. The change from baseline in asthma scores and FEV1 values will be compared     among the control and treatment groups to assess for any benefit of the addition of nebulized     magnesium sulfate to the treatment regimen.   "
204822|NCT00532506|"     The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in     patients with Type2 Diabetes Mellitus   "
204823|NCT00532519|"     Prurigo nodularis (PN) is a common dermatological disorder, manifested as scaly nodules which     appear mainly on the extensor surfaces of the limbs. PN may appear secondarily to skin     scratching in chronic hepatitis, liver cirrhosis, uremia, hypothyroidism etc. Nevertheless,     in many cases no underlying physical disease is present. According to the literature, in     fifty percent of the patients there is co-morbidity with depression, anxiety or somatoform     disorders.      We hypothesize that a group of these patients may benefit from antidepressant therapy.   "
204824|NCT00532532|"     A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity     associated with multiple sclerosis. This study has three purposes:        1. To determine whether AV650 is safe for patients with multiple sclerosis;        2. To gather some early evidence as to whether AV650 is effective in treating spasticity in          patients with multiple sclerosis; and,        3. To assess what the body does with AV650 once it is ingested (Germany and Czech Republic          sites only).   "
204825|NCT00532545|"     To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously,     for one month, are able to produce reliable changes in the bone marker in a severe     osteoporotic population   "
204826|NCT00532558|"     The purpose of the study is to determine the reduction of LDL-cholesterol level after     treatment with 50 mg per day of lapaquistat acetate once daily (QD).   "
204827|NCT00532571|"     To compare the efficacy, safety and tolerability of Coenzyme Q 10 versus placebo in patients     with atypical parkinsonian syndromes corticobasal degeneration (CBD) and progressive     supranuclear palsy (PSP) ).   "
204841|NCT00532766|"     To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)     after subcutaneous administration, and to compare this profile with Humulin insulin.   "
204842|NCT00532779|"     The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR     and bupropion SR are safe and effective in the treatment of obesity.   "
204843|NCT00532792|"     This is a Phase 1/2, randomized, observer-blind, placebo-controlled clinical trial. A maximum     of 500 eligible subjects in 10 groups will be enrolled, randomized and vaccinated in this     study. Subjects will receive an intramuscular injection of either the influenza A/H5N1 (low,     medium or high dose) or placebo on Day 0 and Day 21 with or without a patch. This study will     be performed in two parts.      In Part 1, an initial safety evaluation will be performed in 100 randomized subjects. A     Safety Review Committee (SRC)will review all safety data, including laboratory values,     through the Day 7 visit, and compare those data against Stopping Criteria. If the treatments     are considered safe, Part 2 of the study will be initiated and a second vaccination will be     administered to subjects in Part 1 on Day 21.      In Part 2, the remaining 400 subjects will be randomized, treated, and will follow the same     visit structure and protocol-defined requirements as subjects in Part 1, without the     additional laboratory safety measurements. An SRC review will also be performed of all safety     data through the Day 28 visit for subjects participating in Part 1.   "
204828|NCT00532584|"     Cigarette smoking is the main risk factor for chronic obstructive pulmonary disease (COPD).     The cells lining the lung airways (epithelium) and the cells on the surface of the epithelium     (alveolar macrophages) of healthy smokers develop characteristic gene expression changes that     are different from that of nonsmokers. These gene expression changes include up- and     down-regulation of genes in functional categories known to be relevant to the development of     COPD. Administration of anti-inflammatory medications (inhaled steroids) in combination with     long acting medications that open the airways (bronchodilators), are known to decrease the     rate of acute exacerbations and improve the quality of life of individuals with COPD;     however, the mechanisms underlying these beneficial effects of are poorly understood. This     study will assess the effect of traditional therapy for COPD (inhaled corticosteroids, an     anti-inflammatory medication, plus a bronchodilator, a medication that helps open the     airways) on smoking-induced gene changes in airway epithelium and alveolar macrophages.     Volunteer subjects will be evaluated by bronchoscopy to sample lung cells at 0, 7 and 14     days, with the therapy given at day 1 through day 7. The bronchoscopy aspects of this study     will be covered by approved Weill-Cornell IRB protocol # 0005004439 (see below.)      To participate in this protocol, the research subject will first be enrolled in Weill-IRB     protocol #0005004439 entitled Evaluation of the Lungs of Normal (Smokers, Ex-smokers,     Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and     Bronchial Wall Biopsy, fulfilling the inclusion/exclusion criteria of that protocol. They     will be invited to participate in this protocol only if they meet the additional     inclusion/exclusion criteria of this protocol.   "
204829|NCT00532597|"     The purpose of this study is to determine whether on-line hemodiafiltration ameliorate the     endothelial dysfunction compared with the low flux hemodialysis in end stage renal disease     patients on maintenance hemodialysis.   "
204830|NCT00532610|"     This study assesses for change in heart rhythm of healthy volunteers taking GSK189075 for 3     days at a normal dose and a higher than normal dose compared to placebo or to a single dose     of moxifloxacin. Treatments are GSK189075 500mg daily for three days plus moxifloxacin     placebo on Day 3; GSK189075 4000mg daily for three days plus moxifloxacin placebo on Day 3;     placebo tablets daily for three days plus moxifloxacin placebo on Day 3; placebo tablets     daily for three days plus Moxifloxacin 400mg on Day 3. Volunteers are blindfolded during     dosing. Each volunteer participates in all four treatment periods and will have received each     dose combination at study end. Volunteers will stay at the research unit from the day before     the first dose of study drug until the day after the last dose of study drug of each period.     Safety measures include vital signs, laboratory tests on blood and urine, physical exams and     ECGs. Volunteers wear a Holter monitor (a device that records heart rate and rhythm     continuously) on days 1 and 3. Study drug levels are assessed by multiple blood draws, most     of which occur on day 3.   "
204831|NCT00532623|"     To evaluate the overall response rate of gemcitabine and vinorelbine combination (GV) and     gemcitabine followed by vinorelbine (G⇒V) when used as palliative therapy in patients with     stage IV and recurrent breast cancer.   "
204832|NCT00532636|"     Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and     maintaining an upper airway patent. Designing a ventilating device that could indicate how to     open an upper airway correctly may be beneficial. The head of children is randomly placed in     different head positions by one investigator. A ventilating mask is then pressed gently on     the child's face followed by measurement of the head position angles and pulmonary function.     This information could be utilised to optimise assisted ventilation of an unprotected upper     airway in children.   "
204833|NCT00532662|"     Preemptive analgesia can improve postoperative pain management. Ketamine may prevent central     sensitization during surgery and result in preemptive analgesia. The purpose of this study is     to examine the effectiveness of ketamine as a preemptive analgesic as previous studies have     shown the involvement of N-methyl-D-Aspartate (NMDA) receptor in neuroplasticity.   "
204834|NCT00532675|"     This study will evaluate the safety of LBH589 given in combination with lenalidomide and     dexamethasone in adult patients with multiple myeloma   "
204835|NCT00532688|"     Treatment with n-acetylcysteine in patients with heart failure and chronic renal failure     leads to improvements in vascular function and in renal function.   "
204836|NCT00532701|"     Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400     mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in     patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study     has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who     received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or     standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for     these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high     response rates, several studies have shown that when these patients had rapid virologic     response (RVR), defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA)     levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment     could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin     for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% versus 79%) in     these patients who achieved RVR. While studies showed concordant results in SVR rates for     patients with genotype 3 CHC who received peginterferon plus low dose or weight-based     ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in     patients with genotype 2 CHC who received such treatment. Currently, there are no studies on     the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of     treatment stratified by RVR for patients with genotype 2 CHC. The investigators aimed to     conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of     peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.   "
204837|NCT00532714|"     To evaluate the response rate of capecitabine and irinotecan combination therapy in patients     with metastatic breast cancer   "
204838|NCT00532727|"     The purpose of this study is to determine whether there is greater activity for carboplatin     than a taxane standard of care (docetaxel) in women with ER-, PR- and HER2- breast cancer.     The trial aims to recruit between 370 and 450 patients.   "
204885|NCT00536666|"     The purpose of this study is to determine the safety profile of iron oligosaccharide in     patients with chronic kidney disease with a need for parenteral iron.   "
204844|NCT00532805|"     Individuals with a deficiency of alpha-1 antitrypsin (AAT) often develop emphysema.     Traditional lung function tests may not be the most accurate way to measure the progression     of emphysema. This study will compare high resolution computed tomography (CT) scans to     spirometry to measure the progression of emphysema.   "
204845|NCT00532818|"     The current standard for recurrent, persistent or metastatic cervical cancer is palliative     chemotherapy with cisplatin topotecan, however, the results need to be improved. Epigenetic     aberrations play an important role in cancer progression by silencing growth regulatory genes     and there is now evidence that inhibitors of DNA methylation and HDAC inhibition synergize     the cytotoxicity of chemotherapy.      Objective. To determine the superiority of epigenetic therapy with hydralazine and valproate     plus standard cisplatin topotecan against placebo plus cisplatin topotecan upon     progression-free survival.      Hypothesis. Hydralazine and magnesium valproate associated to cisplatin topotecan will     increase progression-free survival from 4.6 to 7.6 months as compared with the same regimen     of chemotherapy plus placebo.   "
204846|NCT00532831|"     Our hypothesis:      Obese subjects with a physician's made diagnosis of asthma have a poorer asthma control than     asthmatics with normal weight, less variability of peak expiratory flows (PEF) and     bronchodilator response,increased induced sputum and systemic markers of inflammation and an     increased prevalence of atopy.      Obese subjects have an increased incidence of co-morbidities such as rhinosinusitis,     gastroesophageal reflux and sleep apnea syndrome.      This study aims to determine if, in comparison with asthmatics with a normal weight, paired     for age and sex, obese subjects with asthma (all not using anti-inflammatory agents) show:        -  A more uncontrolled asthma, increased health care use and poorer quality of life        -  A reduced response to bronchodilators and diurnal variability of expiratory flows        -  More marked airway inflammation and evidences of a systemic inflammatory response        -  An increased prevalence of co-morbidities which can influence the report of respiratory          symptoms or the severity of the disease, such as esophageal reflux symptoms, upper          airway disease (rhinitis) and sleep apnea syndrome or other sleep disorder.   "
204847|NCT00532844|"     This Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover,     pharmacokinetic (PK) study will compare plasma concentrations of BH4 in subjects with     endothelial dysfunction following 14 days of treatment by each of 2 regimens: 6R-BH4 with     vitamin C and 6R-BH4 alone.   "
204848|NCT00536185|"     We hope to learn more about why certain people have higher levels of the 5-LO protein and     whether taking fish oil supplements gives such individuals greater protection than others     against cardiovascular disease. The 5-LO protein is important in the development of heart     disease because it converts a type of oil from meat into a compound that can cause     inflammation in blood vessels. This inflammation is a major cause of heart disease.      Researchers think that people with higher levels of a protein called 5-LO in their white     blood cells may have a healthier response to using fish oil supplements than do people with     lower levels of this protein.   "
204849|NCT00536198|"     This study will evaluate the effectiveness of sertraline in reducing symptoms in women     diagnosed with premenstrual dysphoric disorder.   "
204850|NCT00536211|"     The purpose of this study is to determine how a decline in physical activity acutely leads to     a decrease in insulin sensitivity in skeletal muscle. The hypothesis is that the loss of     insulin sensitivity following physical inactivity is caused by a rapid reduction in skeletal     muscle mitochondrial oxidative capacity.   "
204851|NCT00536224|"     The purpose of this study is to determine whether a brief counseling intervention initiated     in the chest pain observation unit has a significant impact upon the health attitudes     (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking)     of emergency department patients.   "
204852|NCT00536237|"     Part A: This study will determine that MK0524 is well tolerated and does not effect lipids     and blood glucose when given alone.      Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids     and blood glucose.   "
204853|NCT00536250|"     The purpose of the study is to determine the role of beta-cell function and insulin     resistance in the development of impaired glucose tolerance (IGT) and type 2 diabetes in     children and adolescents who have an increased risk of developing type 2 diabetes due to     overweight/obesity or a family history of overweight/obesity, diabetes and/or impaired     fasting glucose. It is hypothesized that: 1)Obese adolescents with IGT will be more insulin     resistant than obese adolescents with NGT. Insulin resistance will be the best predictor of     changes in glucose tolerance status., 2)Beta cell function will be impaired in obese     adolescents with IGT compared to obese adolescents with NGT., 3)Obese adolescents with IGT     will present with greater intramyocellular, intrahepatic and visceral fat than obese     adolescents with NGT. Furthermore, obese adolescents with IGT will have larger adipocytes,     while having significantly fewer adipocytes compared to obese adolescents with NGT. Obese     adolescents with IGT will also have altered expression of key genes related to insulin     resistance., and 4)Abnormalities in endothelial function as manifested by low FMD and PAT are     already present in obese adolescents with IGT and are linked to insulin resistance.   "
204854|NCT00536263|"     The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron     for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the     approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks.     This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg     once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks     after their treatment ends.   "
204855|NCT00536276|"     To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.   "
204856|NCT00536289|"     The hypothesis for this study is that use of blunt tipped needles used during the repair of     an episiotomy (tear in the vagina after childbirth) will result in fewer needlestick injuries     to the surgeon.   "
204857|NCT00536302|"     This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects.     Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the     other half of the subjects will take a placebo dose, that looks like and tastes like the     collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and     48.   "
204858|NCT00536315|"     The main purpose of this study is use a new type of measurement to help decide what kind of     therapy would help people with a collapsing windpipe or tracheomalacia.   "
204859|NCT00536328|"     Gastric distress is a common phenomenon in our society. Heartburn and regurgitation occur     daily in about 7% of the adult population,weekly 14-20% pf the adults and monthly in 34-44%     of adults. The yearly prevalence of recurrent stomach complaints are frequent reason for     consulting a primary care physician and are an important reason for using OTC medication. A     good diagnosis is important as functional GERD with possible complications such as strictures     and Barrett's esophagus or ulcer disease with life threatening complications such as bleeding     & perforations. The clinical diagnosis of reflux disease is mainly based on symptom     evaluation. This, however, is hindered by the variety of complaints with different etiology.     Treatment with a proton pump inhibitor can be used to confirm the diagnosis reflux disease. A     major part of the patients with acid related stomach complaints indeed will experience     symptom relief after starting PPI therapy. In this view, it is important to identify these     patients who will react on treatment with PPI in quick, accurate, non-invasive and cheap     manner. The Reflux Impact Scale (RIS) is validated, short, self explanatory questionnaire     which asks for the presence & impact of reflux symptoms. The RIS is developed for PCP to aid     in the evaluation & selection of these patient who will profit from treatment with PPI. The     aim of this present study is to determine which questions of the RIS can be predictive for     reaching treatment success with PPI. Treatment success is determined by asking for patients'     satisfaction & completion of the McMaster Overall Treatment Evaluation Heartburn     questionnaire.   "
204860|NCT00536341|"     This phase I/II trial will combine fludarabine, rituximab, and lenalidomide in untreated or     minimally treated (Phase I only) CLL patients, employing fixed doses of fludarabine and     rituximab, using a schedule similar to that examined by investigators at MD Anderson (J Clin     Oncol 23(18):4079-88, 2005). Given that the optimal dose and schedule is not currently known,     this trial will perform a phase I component followed by a phase II examination to further     explore this regimen's activity.   "
204861|NCT00536354|"     This study will examine the effects of postural orientation in the use of school backpacks     among elementary school students.   "
204862|NCT00536367|"     The purpose of this protocol is to determine if the 3 variable mortality prediction model     established using data from a retrospective, multi-center patient registry (The ADHERE Acute     Decompensated HEart FailuRE National Registry) will hold for a prospective, observational     outcome study of OSU patients diagnosed in the Emergency Department (ED)with Acute     Decompensated Heart Failure (ADHF). In the retrospective registry, three parameters were     found to be highly predictive of inpatient mortality for patients admitted with ADHF - on     admission, BUN > 43 mg/dL, systolic BP < 115 mmHg, and Cr > 2.75 mg/dL. However, the very     nature of the ADHERE database limited the analytic potential of this model, as the data     captured by ADHERE is retrospective and limited to the inpatient stay, and the only outcome     evaluated was inpatient mortality. Due to its inherent limitations, the model did not and     could not address longer term outcomes, such as repeat visits to the emergency department     after discharge, or need for readmission to an acute care setting, which frequently occurs     soon after discharge in patients who survive to discharge after being admitted with ADHF.      This observational study will create a registry of patient information obtained from an     interview with the patient and a review of the patient's medical record. Follow up     information at 30 days post discharge will be obtained by phone interview with the patient     and a review of the patient's OSUMC visit history.      Most ED patients diagnosed with ADHF are admitted, as emergency physicians are aware that     heart failure in general carries a very high mortality rate. However, as risk stratification     for ADHF is a severely under researched area, it is not at all clear which patients with     acutely decompensated heart failure will have a poor outcome in the short and intermediate     term. With an improved understanding of the risk profile of our ADHF patients, more     appropriate decision making and disposition assignment can be made.   "
204863|NCT00536380|"     This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20     mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria.     Subjects with chronic urticaria who are currently taking a second generation antihistamine     will be treated with desloratadine (5, 10, or 20 mg) for 28 days.   "
204864|NCT00536393|"     Interest of the use of pegylated liposomal doxorubicin (caélyx)   "
204865|NCT00536406|"     This study will evaluate whether a behavioral activities treatment program improves symptoms     of depression in nursing home residents.   "
204866|NCT00536419|"     The purpose of this study is to determine whether motorcycle drivers with ADHD are at a     greater risk for motorcycle accidents, and whether this risk can be mitigated by treatment     with methylphenidate. We will evaluate the effectiveness of Methylphenidate on driving     performance, among motorcycle drivers, and investigate the correlation between improvement of     ADHD symptoms (inattention and impulsivity) and driving performance.   "
204867|NCT00536432|"     Tetralogy of Fallot is one of the most frequent congenital heart malformations. In many cases     re-interventions, surgical or catheter-based, are necessary after the repair of tetralogy of     Fallot in infancy. At present, informations in the literature about the myocardial benefit     and the timing of re-interventions are missing in this age group. On the other hand, Fallot     patients are dependent on solid criteria for re-interventions, because further interventions     like replacement of the pulmonary valve or balloon dilatations of peripheral pulmonary     stenoses are common.      The objective of this study is to assess the benefit of such interventions for the right     ventricular function. By performing extensive standardised examinations (including MRI,     echocardiography, tissue Doppler,,3D-echocardiography, holter monitoring and quality of life     assessments) before and 6 to 9 months after the re-intervention data of the right ventricular     function are collected. Based on these quantitative data predictive parameters concerning the     right ventricular recovery and information about the time of re-intervention should be     determined.   "
204868|NCT00536445|"     The present protocol will demonstrate the feasibility and efficacy of a newly developed mode     of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA.     During NAVA, the timing and magnitude of pressure delivered are controlled by the infants'     diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive.     Recent clinical trials in adults and term infants have shown that NAVA is more synchronous     than conventional pressure support ventilation, and that NAVA delivers lower mean airway     pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently     been approved for use in neonates by Health Canada and the FDA in the United States, and is     commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The     present protocol is designed as a case study where the researchers responsible would like     to evaluate the feasibility and efficacy of ventilating a premature baby on NAVA with the     Servoi for 12 hours.   "
204869|NCT00536458|"     To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of     chemotherapy in the treatment of localiezd low grade lymphoma   "
205568|NCT00526981|"     The study will test the hypothesis that the prone position can be used to reduce the need for     intubation and mechanical ventilation in patients with acute respiratory failure.   "
204870|NCT00536471|"     Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized,     placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to     compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on     depression in patients aged 18-65. Data from the two trials will be reported in both     individual and pooled analyses. Pooling the two studies will allow for increased power to     detect differences between duloxetine and placebo on secondary and exploratory objectives.     Only one data lock is planned for this study, when all patients have completed all study     procedures.   "
204871|NCT00536484|"     This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more     effective than placebo in reducing micturition frequency and other overactive bladder (OAB)     symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder     and if the fesoterodine regimen is safe and well tolerated.   "
204872|NCT00536497|"     GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical     development as a novel oral treatment for inflammatory pain. The purpose of the study is to     compare the effects of formulation, food and particle size on the pharmacokinetic profiles of     a single 175mg dose of GW842166X in healthy male and female volunteers.   "
204873|NCT00536510|"     The primary objective of the study is to assess the effects of MK0524A in reducing     cholesterol levels in an Asian population.   "
204874|NCT00536523|"     RATIONALE: Gathering information about changes in serotonin levels in patients undergoing     chemotherapy for ovarian cancer, fallopian tube cancer, or primary peritoneal cancer may help     doctors learn more about constipation caused by chemotherapy.      PURPOSE: This clinical trial is studying how blood levels of serotonin effect constipation     caused by chemotherapy in patients with newly diagnosed ovarian cancer, fallopian tube     cancer, or primary peritoneal cancer.   "
204875|NCT00536536|"     Obesity affects one in five children in the UK and undoubtedly causes increased ill health     with rising levels of childhood and adolescent diabetes, obesity induced liver disease and     increased risk of early heart disease. There are few clinics offering effective treatment for     childhood obesity. However, the clinic for childhood obesity at Bristol Royal Hospital for     Children (BCH) has been successful in around 83% of cases. This pilot study aims to examine     the feasibility of transferring the success of the hospital clinic to primary care in     preparation for a full RCT. The study will entail training a practice nurse, community     dietician and exercise specialist to deliver the same clinical service in primary care as     that offered in BCH. Initial work will gather the views of staff delivering the hospital     service and those of patients and parents to identify the crucial components of the     intervention that are likely to be needed in primary care and to then to refine the     intervention.A pilot trial will examine how feasible it is to recruit patients into the     service and get some initial idea as to whether weight management is equally good, patient     satisfaction and retention improves and what data needs to be collected for a full economic     assessment. If found to be effective, the next step will be to use knowledge gained in this     study to design and undertake a more extensive, formal study across Bristol in various     primary care settings.This larger study will address how such a service can be delivered     across a complete spectrum of primary care populations, so that similar services could be     developed across the country.   "
204876|NCT00536549|"     The purpose of this study is to determine whether the Guardian Continuous Glucose Monitoring     System in the home setting is more useful than frequent self blood glucose monitoring with a     view to modifying patient's diet and exercise habits or improvement self disease control     efforts and at last glycemic control in patients with type 2 diabetes   "
204877|NCT00536562|"     The purpose of this study is to determine, in patients following a TIA, whether a 6-month     case-managed exercise based multi-factorial cardiac rehabilitation program (CR), similar to     those used in patients following a heart attack, can significantly improve exercise capacity,     reduce cholesterol, reduce depression, and improve thinking ability.   "
204878|NCT00536575|"     This is a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in     initial patients. The initial patients on the dose-finding portion of this study will be     enrolled through a single institution. Following establishment of the Phase II dose the study     will open enrollment throughout the Sarah Cannon Research Institute (SCRI) Oncology Research     Consortium.      The purpose of this study is to develop the combination of bortezomib (which is proven to be     clinically active in patients with multiple myeloma) with sorafenib (a potent inhibitor of     angiogenesis). This regimen will be developed in a schedule that is convenient for patients,     and that is as minimally toxic to patients as possible.   "
204879|NCT00536588|"     The purpose of this first-in-human study is to determine the safety and tolerability of SCH     721015 in subjects with transitional cell carcinoma of the bladder.   "
204880|NCT00536601|"     This pilot trial studies different high-dose chemotherapy regimens with or without total-body     irradiation (TBI) to compare how well they work when given before autologous stem cell     transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving     high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by     stopping them from dividing or killing them. After treatment, stem cells are collected from     the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for     the stem cell transplant. The stem cells are then returned to the patient to replace the     blood forming cells that were destroyed by the chemotherapy.   "
204881|NCT00536614|"     This is multicenter, open-label, randomized, phase II trial in patients with locally advanced     or metastatic pancreatic cancer. Primary objective: objective response rate. Secondary     objectives: safety, time to disease progression, median duration of response, time to     treatment failure, overall survival time, correlation between bio-pathological     characterization (EGFR, akt, MAPks) objective response and survival   "
204882|NCT00536627|"     The purpose of this study is to determine if DNA vaccination of chronic HBV patients under     treatment with NRTI can restore T-cell responsiveness and delay virologic reactivation after     treatment discontinuation.   "
204883|NCT00536640|"     This study wants to determine the activity of a non chemotherapy first line biological     treatment with Erlotinib/Bevacizumab or Gemcitabine-Cisplatin/Bevacizumab in patients with     the diagnosis of non-squamous advanced Non Small Lung Cancer.   "
219013|NCT00711074|"     The purpose of this study is to determine how the body breaks down and excretes the     investigational drug, AZD5672.   "
204886|NCT00536679|"     The study will consist of a screening period, 3 treatment periods and a post-treatment     follow-up. In each of the 3 treatment periods, subjects will receive a single oral dose of     GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose   "
204887|NCT00536692|"     This is an open-label study evaluating the safety and tolerability of topical ocular     mecamylamine given twice a day in patients with diabetic macular edema (DME). Patients will     be treated for 12 weeks.   "
204888|NCT00536705|"     The Objective of our research is to observe the effect of cysteinyl leukotriene receptor     antagonist on the expression and variation of TGF-β1 levels and mRNA expression in children     with mild persistent asthma in their plasma and T lymphocyte, to discuss the role of TGF-β1     in the pathogenesis of bronchial asthma in children and to evaluate the function of     regulation of leukotriene receptor antagonist on asthma in children.   "
204889|NCT00536718|"     RATIONALE: Gathering information about genetic changes in patients with lobular carcinoma in     situ of the breast may help doctors learn more about the disease and find better methods of     treatment.      PURPOSE: This clinical trial is studying the genetics of women with lobular carcinoma in situ     of the breast.   "
204890|NCT00536731|"     The purpose of the this study is to evaluate the efficacy and safety of 2 actuations     Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5     μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.   "
204891|NCT00536744|"     The purpose of this study is to compare the safety and effectiveness of the dermaPACE Device     to sham application, when administered in conjunction with standard treatments used in the     treatment of DFUs.   "
204892|NCT00536770|"     The purpose of this study is to determine the safety and efficacy of an investigational study     drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the     treatment of pancreatic cancer.   "
204893|NCT00536783|"     The purpose of this study is the use of magnetoencephalography or MEG (a machine that     measures magnetic activity in your brain) and electroencephalography or EEG (a technique that     measures electrical activity in your brain) to study how sounds are processed in individuals     with schizophrenia after three months of taking the antipsychotic medication quetiapine.   "
204894|NCT00536796|"     A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia     (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and     rate of patients who are treated to target (which is <100mg/dl for patients with high risk     and <70mg/dl for patients at very high risk) are screened (hospital-based specialists). The     doctors therapy decisions after the screening and possible reasons for these decisions will     be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are     treated to their LDL-C target and to underline the importance of treating patients to their     cholesterol targets.   "
204895|NCT00536809|"     The purpose of this study is to determine the highest, tolerated dose level and safety of     lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the     clinical activity of the combination of drugs in subjects with previously untreated advanced     or metastatic colorectal cancer.   "
204896|NCT00536822|"     It is believed that children with a prior history of significant burn injury continue to     manifest low levels of antioxidants well into their convalescence.The purpose of this study     is to examine malondialdehyde (an oxidative lipid marker) and vitamins E, C and beta carotene     status in reconstructive burn patients.   "
204897|NCT00536835|"     This is a first time in human study that is being done to determine the maximum tolerated     dose and initial pharmacokinetic parameters of GSK461364, given by IV, in adult subjects with     solid tumors and Non-Hodgkins lymphoma.   "
204898|NCT00536848|"     The purpose of this study is to asses whether probiotics Lactobacillus rhamnosus (GR-1) and     reuteri (RC-14) are able to prevent diarrhea, delay the decline of the immune system and     prevent and/or cure bacterial vaginosis among HIV patients.   "
204899|NCT00536861|"     Lung cancer is a leading cause of death worldwide. Brain metastases manifest as the first     site of disease failure in between 15-30% of patients with non-small cell lung cancer     (NSCLC). The standard treatment for patients with multiple brain metastases is whole brain     radiotherapy but this results in only a modest survival of 3-6 months. Drugs that can enhance     the effect of cranial irradiation (radiosensitizers) may improve the the response rates.     Erlotinib (Tarceva) is an oral agent that has been registered for treatment in patients with     metastatic NSCLC. Erlotinib has shown tumor activity in patients presenting with brain     metastases, and preclinical studies show that it may be a radiosensitizer. As a prelude to     studies investigating the combination of Erlotinib and cranial radiotherapy, the present     study will be performed to evaluate the safety of combining both these treatments.   "
204900|NCT00536874|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount     of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any     tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with     oxaliplatin works in treating patients with pancreatic cancer that can be removed by surgery.   "
204901|NCT00536887|"     Many data indicate that statins increase mobilization of bone marrow-derived stem cells, and     circulating bone marrow-derived stem cells are capable of homing to sites of myocardial     infarction and endothelial disruption, thereby restoring myocardial function and     microvascular integrity after acute myocardial infarction. Atorvastatin is widely used in the     treatment of hyperlipidemia, especially after acute myocardial infarction. High-dose     atorvastatin has been known to stop the progression of atherosclerosis and to decrease the     levels of inflammatory markers.      The purpose of this prospective, randomized, single-blinded trial is to compare the effect of     atorvastatin 10 mg versus 40 mg in restoring coronary flow reserve (CFR) and in serial bone     marrow stem cell mobilization during the 8 months follow-up in patients with acute myocardial     infarction.   "
204902|NCT00536900|"     This is a randomized controlled trial to test whether a money-management based intervention     reduces substance abuse.   "
205569|NCT00526994|"     This is a randomized controlled trial with three arms to establish the impact of screening     and referral to services for women disclosing exposure to IPV.   "
204903|NCT00536913|"     The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of     steroid potency, improvement of lung function and asthma symptoms in children with asthma     (6-11 years).   "
204904|NCT00536926|"     In an investigation should be evaluated in contrast to a control group with standard     post-treatment therapy (using home spirometry) after lung transplantation if transfer of home     spirometry recordings to the transplant center via cell phones will lead to less     complications, cost savings and bigger constancy of therapy.   "
204905|NCT00536939|"     The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and     enzastaurin versus paclitaxel, bevacizumab, and placebo in patients who are diagnosed with     locally recurrent or metastatic breast cancer.   "
204906|NCT00536952|"     RATIONALE: Nebulized dornase alfa inhalation solution may decrease the thickness of saliva in     the mouth and improve quality of life in patients undergoing radiation therapy and     chemotherapy for head and neck cancer. It is not yet known whether dornase alfa inhalation     solution is more effective than a placebo in lessening the discomfort of treatment in these     patients.      PURPOSE: This randomized clinical trial is studying how well dornase alfa inhalation solution     works compared with a placebo in treating patients with stage III or stage IV head and neck     cancer undergoing radiation therapy and chemotherapy.   "
204907|NCT00536965|"     A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia     (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and     rate of patients who are treated to target (which is <100mg/dl for patients with high risk     and <70mg/dl for patients at very high risk) are screened (office-based specialists). The     doctors therapy decisions after the screening and possible reasons for these decisions will     be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are     treated to their LDL-C target and to underline the importance of treating patients to their     cholesterol targets.   "
204908|NCT00536978|"     Primary objective:        -  To determine the safety of adback T- or Natural Killer (NK) cells in patients with          lymphoid malignancies receiving allogeneic stem cell transplantation with Campath-IH          containing conditioning regimen.      Secondary objective:        -  To determine the efficacy (disease-free-survival) of this strategy.   "
204909|NCT00536991|"     This phase I/II trial studies the side effects and best dose of calcitriol when given in     combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in     treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more     like normal cells and grow and spread more slowly. Ketoconazole and therapeutic     hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the     drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a     better treatment for prostate cancer.   "
204910|NCT00537004|"     The purpose of this study is to further define the neurological and linguistic deterioration     in primary progressive aphasia.   "
204911|NCT00537017|"     The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in     participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa     decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in     the main study (P04501; NCT00406029) entitled A Phase 2, 12 Week, Double Blind, Dose     Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814     Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations     and Dyskinesias.   "
204912|NCT00537030|"     This clinical trial is studying the side effects of Erwinia asparaginase and what happens to     the drug in the body in treating young patients with acute lymphoblastic leukemia who are     allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing.   "
204913|NCT00537043|"     Carvedilol controlled release is a marketed drug to treat high blood pressure. This study is     to compare carvedilol controlled release to carvedilol controlled release plus lisinopril     (fixed-dose combination) after repeat dosing in patients with high blood pressure. This is to     make sure that when carvedilol controlled release is given with lisinopril it acts the same     in the body as when given alone. The study will also assess the safety and tolerability of     the fixed-dose combination.   "
204914|NCT00537056|"     To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed     tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE     MRI) are better predictors of response to therapy than the current standard of care (CT or     MRI).   "
204915|NCT00537082|"     To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese     patients with relapsing multiple sclerosis (MS)   "
204916|NCT00537095|"     This is a parallel group, randomized, double blind, placebo controlled, multicentre study     designed to assess whether vandetanib (ZD6474) confers an improvement in PFS as compared to     placebo in subject with locally advanced or metastatic papillary or follicular thyroid     carcinoma failing or unsuitable for radioiodine therapy. The trial should be of a sufficient     size so that if vandetanib (ZD6474) is truly active there is a high probability that it will     demonstrate an effect sufficiently promising to warrant a follow-up assessment.        -  Subjects will be seen weekly for the first 2 weeks, then again at Week 4, Week 8, and          Week 12 after randomization, and every 12 weeks thereafter. Upon disease progression,          all subjects (both active and placebo) will be unblinded and given the option to          discontinue blinded study treatment and enter follow up and survival, or begin open          label vandetanib (ZD6474) 300 mg treatment. All subjects will be followed to collect          survival data until ≥50% of subjects have died. Subjects who are taking vandetanib          (ZD6474) at the time of study closure and wish to remain on therapy will be allowed to          continue for as long as the Investigator feels that they are obtaining clinical benefit,          or until they are given another anti-cancer therapy. The safety data from all subjects          will be assessed on an ongoing basis, including discontinuation and follow up.        -  Radiologic evaluation using RECIST criteria will be performed every 12 weeks (± 2          weeks). All medical images will be centralized assessed at the site and centrally          reviewed. Subjects will be evaluated until progression, and will then be followed up for          survival, regardless of whether they continue randomized treatment, unless they withdraw          consent. Post progression open-label vandetanib (ZD6474) will be offered at the          investigators discretion.        -  All subjects must submit a suitable archived tumor sample prior to randomization. In the          event that a suitable archived sample is not available within 2 weeks prior to          randomization, a fresh tumor sample must be obtained in its place prior to          randomization. If a subject undergoes the fresh tumor biopsy procedure, this specimen          will satisfy the first optional tumor biopsy submission should they consent to the          exploratory part of the study.   "
204931|NCT00537290|"     RITuximab AntiphosPholipid Syndrome (RITAPS) Study is designed to evaluate whether a     medication called rituximab would reduce the signs and symptoms of antiphospholipid antibody     (aPL) -related certain clinical problems.   "
205704|NCT00534846|"     The purpose of this study is to determine the effect of toremifene treatment to the MRI     findings of the breast in women suffering from premenstrual mastalgia.   "
204917|NCT00537108|"     Teenagers who become parents often struggle with new challenges as they try to take care of     their children and themselves. Programs that provide teens with support, education, and     counseling may help teens to become the best parents they can be and reach their own goals.     Health care providers who take care of pregnant and parenting teenagers are trying to find     out what types of programs are most helpful for the physical, emotional, and social health of     pregnant and parenting teenagers. The purpose of this study is to find out what kinds of     activities help teens be successful as parents and achieve success in their lives.   "
204918|NCT00537121|"     RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and     leucovorin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving vorinostat together with combination     chemotherapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when     given together with irinotecan, fluorouracil, and leucovorin in treating patients with     advanced upper gastrointestinal cancer.   "
204919|NCT00537134|"     The management of patients with unruptured aneurysms is controversial. Patients with     unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is     still debated. Endovascular treatment can prevent rupture, but involves immediate risks;     furthermore, successful treatment does not eliminate all risks. A randomized trial may be the     best way to demonstrate the potential benefits of endovascular over conservative management     of unruptured aneurysms.   "
204920|NCT00537147|"     West Nile (WN) virus infection is an emerging disease. Infection with WN virus may lead to     paralysis, coma, and death. The purpose of this study is to determine the safety of and     immune response to a two-dose regimen of a WN vaccine in healthy adults. The vaccine is based     on a live attenuated vaccine developed against dengue virus.   "
204921|NCT00537160|"     Examine clinical results of an interdisciplinary weight management program that includes     medical evaluation, nutrition counseling, exercise, and behavioral interventions.   "
204922|NCT00537173|"     This trial provides a unique opportunity in that it combines genomic, proteomic and     pharmacogenomic assessments in patients receiving chemotherapy for advanced breast cancer. To     date no other trials have analyzed gene and protein expression at the same time points in the     same patient, combined with clinical outcome. Similar to previous attempts to predict     response based on expression of a single gene or protein, we expect that neither genomic or     proteomic profiling alone will be sufficient to optimize therapy. Rather, we expect an     iterative process that combines information gleaned from both platforms, modified to avoid     toxicity based on pharmacogenomics.   "
204923|NCT00537186|"     The purpose of this study is to determine the safety profile of iron oligosaccharide in     patients with congestive heart failure with a need for parenteral iron.   "
204924|NCT00537199|"     Primary Objectives:        1. To assess the ratio in sensitivities of OraTest® in combination with visual examination          versus visual examination alone in the detection of serious pathology defined as severe          dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for          squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the          oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors.        2. To estimate the adjusted specificity of OraTest® in combination with visual examination          in the detection of severe dysplasia, CIS, or cancer of the O/OP cavity.      Secondary Objectives:        1. To assess the ratio of sensitivity of OraTest® in combination with visual examination          versus visual examination alone in the detection of certain chromosomal abnormalities          (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia,          CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell          carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP)          cavity due to their age and lifestyle risk factors.        2. To obtain the adjusted specificity of OraTest® in combination with visual examination in          the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both          3p and 9p chromosomal deletions), severe dysplasia, CIS or cancer of the O/OP cavity.        3. To evaluate the chromosomal status of the positively staining lesions with respect to          3p, 9p, or 17p deletions.        4. To carry out gene expression studies on biopsies and map these onto an analysis of the          widespread chromosomal imbalances in stain-positive and stain-negative lesions.        5. To evaluate the quantitative and qualitative toxicities, as well as other safety          parameters, of tolonium chloride 5 mg/mL (OraTest®).   "
204925|NCT00537212|"     The association between psoriasis and obesity has been questioned by physicians for many     years. Studies have shown that the risk of having psoriasis is increased in people with a     high body mass index, which is a measurement of obesity. There have been case reports of     remission of psoriasis after gastric bypass surgery. Furthermore, other studies have shown     that certain inflammatory diseases (such as rheumatoid arthritis) can be improved by dietary     changes. The purpose of this study is to assess whether a low carbohydrate or low fat diet     can be helpful in the treatment of psoriasis.   "
204926|NCT00537225|"     Patients with peripheral arterial disease (PAD) experience significant functional limitations     due to ischemic symptoms (claudication) and are at high risk for CVD morbidity and mortality     resulting from untreated cardiovascular disease (CVD) risk factors and aggressive     atherosclerosis. The overall Goal of this randomized controlled clinical trial is to examine     the synergistic effect of a multifactor risk reduction on walking distance, blood flow and     quality of life in 300 patients with PAD.      Specifically, we will compare the effects of 24 months of a novel, yet well-tested multiple     risk factor reduction program, the Health Education and Risk Reduction Training (HEAR2T)     Program for PAD versus enhanced standard care on: 1) symptom limited walking distance as     assessed by treadmill exercise testing and walking impairment questionnaire; 2) endothelial     function as measured by flow mediated vasodilation (FMVD) via brachial artery ultrasound. We     will also explore the association between FMVD and decreased oxidative stress (as measured by     oxygen radical absorbance capacity and urinary isoprostanes) and reduced degradation of     nitric oxide (NO) and/or increased NO biosynthesis (as measured by urine nitrogen oxide,     plasma nitrogen oxide, plasma asymmetric dimethylarginine, plasma, urine and platelet cyclic     GMP).      Secondary hypotheses examine the association between reducing CVD risk factors, improved     endothelial function, increased walking distance, improved quality of life and number of     metabolic syndrome abnormalities in PAD patients.      Significance. This study will contribute to evidence on the efficacy of multiple risk factor     reduction on improving physical function and quality of life in the understudied, elderly PAD     patient. This study will also provide preliminary evidence for the biological basis for the     efficacy of multifactor risk reduction in restoring vascular homeostasis, critical because of     its role in antiatherogenesis and maintaining vasoreactivity, both necessary for slowing the     progression of atherosclerosis.   "
204927|NCT00537238|"     This study will compare pregabalin and levetiracetam in patients with partial seizures. It     will also evaluate the safety and tolerability of pregabalin and levetiracetam in these     patients.   "
204928|NCT00537251|"     To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of     treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as     mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as     mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety     of both treatments, evaluated through hypoglycemic rates.   "
204929|NCT00537264|"     The aim of this study is to compare a multimedia, computerised approach vs. interviewer     administration of health-related quality of life (HRQoL) instruments.   "
204930|NCT00537277|"     This trial is conducted in Europe.      This is a clinical trial investigating the effectiveness and the safety of using biphasic     insulin aspart 30 both for initiation and intensification of insulin treatment in type 2     diabetes.   "
204932|NCT00537303|"     This trial is conducted in Europe, Africa and the United States of America (USA).      The aim of this trial is to compare the safety and efficacy of two different insulin     treatments, the basic and the advanced treatment in type 2 diabetes.   "
204933|NCT00537316|"     Part 1 of this study is a 3-arm, randomized, active-controlled, parallel-group, multicenter,     double-blind, double-dummy, 16-week study to compare the efficacy and safety of infliximab     (IFX), as monotherapy or in combination with azathioprine (AZA) versus AZA monotherapy in     adults with moderate to severe active ulcerative colitis (UC). Participants who qualify at     the Baseline Visit will be eligible to be randomized to one of the three active treatment     groups.      Participants in the IFX/AZA combination therapy and IFX monotherapy cohorts will receive IFX     infusions at Weeks 0, 2, and 6 and daily oral AZA/placebo, respectively; participants in the     AZA cohort will receive daily oral AZA and placebo infusions at Weeks 0, 2, and 6. At Week 8,     all participants will be evaluated for response.      Participants responding to IFX treatment at Week 8, either as monotherapy or in combination     with AZA, will receive one more IFX infusion at Week 14; non-responders to IFX therapy will     receive placebo infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14.      Participants responding to AZA monotherapy at Week 8 will continue on AZA therapy and receive     one placebo infusion at Week 14; nonresponders to AZA will be eligible to receive IFX at     Weeks 8, 10, and 14.      Part 2: Participants in remission on IFX monotherapy or IFX/AZA treatment at Week 16 will be     randomized to either maintenance or intermittent open-label IFX treatment; randomization will     be stratified based on oral AZA/placebo treatment in Part 1. Oral AZA/placebo treatment will     continue to be double-blinded. All participants will continue to receive oral AZA/ placebo     for the duration of the study.      Participants randomized to maintenance IFX treatment will receive scheduled IFX infusions     every 8 weeks beginning at Week 22 (Week 6 for direct entry). If participants lose response,     or if treatment has to be discontinued because of an adverse event, these participants are     considered treatment failures, and should be followed up for safety at the scheduled 6-month     visits (Weeks 38, 62, and 94 [Weeks 22, 46, and 78 for direct entry]). These participants     will receive standard of care per their personal physician.      Participants randomized to intermittent IFX treatment will be evaluated every 8 weeks.     Participants will receive IFX only upon relapse of disease. Treatment with IFX will be     initiated at Weeks 0, 2, and 6 of the individual treatment cycle and will continue every 8     weeks until remission is regained. Throughout the study, individual treatment cycles will be     repeated whenever a subject relapses.      In addition, to facilitate enrollment into Part 2, participants who received treatment     outside of Part 1 and who are in remission on IFX with or without AZA/6-mercaptopurine (6-MP)     will be allowed to enter directly into Part 2. In the Czech Republic, direct entry into Part     2 of the study is not allowed.      A higher than expected incidence of serious infusion reactions observed in the intermittent     treatment arm of another study (Protocol P04563, NCT0358670) conducted in participants with     moderate to severe psoriasis resulted in the termination of that study. Based on the     similarities in study design between the intermittent treatment arm of P04563 and the     intermittent treatment arm of Part 2 of this study, enrollment to Part 2 of this study was     put on hold, for precautionary reasons. At the same time, all participants already enrolled     in the intermittent treatment arm of Part 2 were asked to discontinue from the trial. In     October 2009, a decision was made by the sponsor to terminate the whole study (Part 1 and 2).     At that time, participants enrolled in Part 1 of the study were allowed to complete their     treatment up to Week 16.   "
204934|NCT00537329|"     The purpose of this study is to determine whether or not the Investigational Study Drug     anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in     Asian subjects.   "
204935|NCT00537342|"     The objective of this trial is to evaluate the clinical effectiveness of the administration     of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or     allergic rhinoconjunctivitis   "
204936|NCT00537355|"     This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter     study. After passing the initial Screening Visit, subjects will be in the environmental     exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each     day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total     Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo     treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the     study drug. About three weeks after the last injection, subjects will be asked to be in the     EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after     Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits     13-16, Days 82-85).      During all EEC visits, the subjects will be exposed to ragweed pollen at an average     concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours.     During each EEC visit, patients will be asked to record symptom scores for nasal and     non-nasal symptoms at scheduled time points.      The total duration of a subject's participation in this study is expected to be a minimum of     85 days.   "
204937|NCT00537368|"     The purpose of this study is to determine if CNTO 888 is safe and to determine how long CNTO     888 stays in the body and what effects it might have on cancer tumors.   "
204938|NCT00537381|"     The purpose of this study is to assess the effects of intetumumab when given in combination     with docetaxel and prednisone to participants with metastatic (spread of cancer cells from     one part of the body to another) hormone-refractory (not responding to treatment) prostate     cancer (abnormal tissue that grows and spreads in the body until it kills).   "
204939|NCT00537394|"     The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV     requires at least two anti-HIV drugs that are active against the virus. Drug resistance is a     problem for many treatment-experienced, HIV-infected people. The purpose of this study was to     determine the benefit of adding a nucleoside reverse transcriptase inhibitor (NRTI) to a new     anti-HIV drug regimen for the suppression of HIV.   "
204940|NCT00537407|"     Debio 025 (alisporivir) is an oral cyclophilin inhibitor with a new mechanism of action     demonstrating potent anti-hepatitis C virus (HCV) activity in pre-clinical models and     patients.      The current standard of care (SOC) in HCV patients consists of a combination of peg-IFN alpha     and ribavirin. Treatment duration and ribavirin dose depend on the genotype treated. Only     40-50% of patients with genotype 1 achieve a sustained viral response (SVR). This study     assesses whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin     can improve the outcome of treatment in this group of patients.   "
204941|NCT00537420|"     The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24     weeks of treatment.   "
204942|NCT00537433|"     Liquid medication administration errors are common, and place children at risk for adverse     events. Caregivers with low socioeconomic status (SES), low education and poor health     literacy skills are at increased risk for errors. In this study, we seek to assess whether     at-risk parents who received a plain language, pictogram-based intervention would have     reduced medication dosing errors and improved medication adherence.   "
204943|NCT00537446|"     Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig's Disease, is a fatal disorder that     causes progressive degeneration and weakening of the muscles of breathing, leading to     breathing insufficiency and eventually breathing failure. This breathing insufficiency is     commonly treated with a breathing assistance device, known as noninvasive positive pressure     ventilation (NIPPV). While generally well tolerated and accepted, it is not clear whether or     to what extent NIPPV in fact helps breathing function: some data suggest that NIPPV preserves     breathing function over time, whereas other data suggest that it actually causes breathing     function to decline more quickly. No studies have shown what the acute effect of NIPPV is on     breathing muscle function in ALS patients.      This study will test the hypothesis that the acute use of NIPPV, at pressure levels that are     in common clinical use, will cause measurable changes in tests of breathing function,     compared to baseline and to lower levels of NIPPV. We expect that the results of this study     will help to clarify whether and to what extent NIPPV assists respiratory muscle function in     patients with ALS.   "
204944|NCT00537459|"     16448 is being investigated for the treatment of primary premature ejaculation (PE) using a     novel mode of action. There are no approved therapies for premature ejaculation, and novel     therapies are needed for this syndrome.      16448 has been shown to increase ejaculatory latency in the PCA rat model of premature     ejaculation.      A novel instrument, the Sexual Assessment Monitor (SAM), will be used to measure ejaculatory     latency time in this study. This device, which measures ELT under standard conditions, has     been shown to provide a more reliable measure of ejaculatory latency compared to the use of a     stopwatch during sexual intercourse   "
204945|NCT00537472|"     This study plans to investigate whether a reduced dose of bupivacaine (a local anesthetic     numbing drug) injected into the spinal space for a total knee replacement will result in a     shorter time to discharge from the recovery room while maintaining adequate surgical     anesthesia.   "
204946|NCT00537485|"     To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a     multi-center, placebo-controlled, double-blind study following once-daily multiple     transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose     titration/maintenance period)   "
204947|NCT00537498|"     The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000     000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in     patients with diabetic foot syndrome.   "
204948|NCT00537511|"     The purpose of this study is to determine the maximum tolerated dose and safety of CC-4047     (pomalidomide) given in combination with cisplatin and etoposide in patients with extensive     disease small cell lung cancer.   "
204949|NCT00537524|"     Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months     to 17 years compared to seasonal flu vaccination   "
204950|NCT00537537|"     This study is to evaluate the antiviral efficacy of add-on adefovir to telbivudine in     non-responders to telbivudine monotherapy after 24 and 36 initial weeks. Antiviral efficacy     is assessed by hepatitis B virus (HBV) DNA non-detectability (PCR <300 copies/ml) by week 104     with CHB.   "
204951|NCT00537550|"     The present study has been designed to give participating centers the possibility of better     understanding the diagnostic and prognostic factors of ALL patients.   "
204952|NCT00537563|"     Clinical efficacy between telithromycin and moxifloxacin at the post-therapy/test of cure     visit, and to assess the safety of telithromycin given once daily for 5 days vs moxifloxacin     given once daily for 10 days in the treatment of subjects with AMS.   "
204953|NCT00537576|"     The purpose of this study is to evaluate the safety, tolerability and acceptability of a new     formulation of Lactobacillus crispatus, strain CTV-05 (LACTIN-V) in healthy pre-menopausal     women. Osel, Inc. proposes that this new formulation will be safe and well-tolerated in     healthy pre-menopausal women.   "
204954|NCT00537589|"     Does ultrasound guidance improve success rate and decrease aspiration attempts for peripheral     arthrocentesis?   "
204955|NCT00537602|"     Cystic fibrosis is a genetic disease caused by mutation of the cystic fibrosis transmembrane     conductance regulator (CFTR). The purpose of the study is to investigate the effects of     miglustat on CFTR function in cystic fibrosis patients.   "
204956|NCT00537615|"     The purpose of this study is to investigate the absorption, metabolism and excretion of [14C]     PD 0332334 to characterize plasma, fecal and urinary radioactivity and identify any     metabolites of [14C] PD 0332334.   "
204957|NCT00537628|"     Primary Objectives        1. Mid Region pro Adrenomedullin (MR-proADM) is superior to BNP for the prognosis of heart          failure (HF) patients and adds incremental value in predicting outcomes for patients          presenting to the Emergency Department (ED) with shortness of breath.        2. Mid Region pro A-Type Natriuretic Peptide (MR-proANP) is non-inferior to BNP for the          diagnosis of HF in patients presenting to the ED with shortness of breath.   "
204958|NCT00537641|"     This study will test the hypothesis that noninvasive ventilation (NIV) as prescribed in     current medical practice for use in amyotrophic Lateral Sclerosis (ALS) patients fails to     deliver adequate breathing support over a night of use in the patient's home. ALS patients     who come to the ALS Center for their routine 3 month follow up exam and are currently using     NIV will be asked to complete questionnaires regarding their quality of sleep, quality of     life and general level of function, and to undergo a home sleep study, using a safe,     comfortable and reliable breathing monitoring system during a night of sleep. If the     questionnaires or the sleep study show failure of the breathing device, the investigators     will work with the patient to fix the problem and then offer a second study to make sure that     the changes were helpful. The results of this study may help to develop subsequent studies     and to improve the guidelines used for care of ALS patients.   "
204959|NCT00537654|"     This study will be an open-label, randomized, single dose, three way partial crossover study     in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose     combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram     [mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin     hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy     adult male subjects will be enrolled into the study. Subjects will receive single oral doses     in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC,     ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available     tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose     combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4     mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin     hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination     formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg     tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a     minimum 28 day washout period. The total duration of a subject's involvement in this study is     approximately 15-18 weeks.   "
204960|NCT00537667|"     The purpose of this study is to compare IL-1ra and the combination of IL-1ra and PEGsTNF-RI     with respect to their ability to reduce inflammation and bone and cartilage destruction in     the synovium of subjects with rheumatoid arthritis.   "
204961|NCT00537680|"     This study is meant to assess the effectiveness of idebenone on neurological outcome measures     in patients with Friedreich's Ataxia over a 6 months period.   "
204962|NCT00537693|"     This pilot study will compare the effect of diffusive versus convective Continuous Renal     Replacement Therapy (CRRT) in children with sepsis who require CRRT.      The hypothesis for the study is that convective forms of CRRT provide enhanced clearance of     cytokines and improved clinical responses as compared to a diffusive CRRT modality.   "
204963|NCT00537706|"     This study will identify what programs, along with traditional healthcare, low-income urban     residents would choose to improve their health. The information is intended as a step toward     designing public policies aimed at improving the health of low-income populations in the     United States.      Residents of Washington, D.C., who are between 18 and 64 years of age and are in a specified     income bracket may be eligible for this study.      Participants take part in audio-taped group discussions led by a trained facilitator. During     a 3 hour session, participants engage in 4 cycles of choosing benefits. Participants select     benefits as follows:        -  For themselves individually.        -  For their neighborhood.        -  For an entire city.        -  Once again individually.   "
204964|NCT00537719|"     This study will use scintigraphy techniques to measure gastric emptying rate of liquid and     solid food at baseline and after administration of GSK716155 or placebo.   "
204965|NCT00537732|"     Patients with gastroesophageal reflux disease (GERD) are either treated for 4 weeks with a     standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing     (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. The     individual elimination capacity is genetically controlled and therefore all patients will be     genotyped prior to therapy.   "
204966|NCT00537745|"     The purpose of this study is to determine whether Vivitrol is effective at reducing attempts     to drive after drinking among repeat driving while intoxicated (DWI) offenders with Ignition     Interlock devices.   "
204967|NCT00537758|"     This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL)     treatments for obese patients with binge eating disorder (BED). The study involves a     comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part)     treatment consisting of CBT followed by BWL.   "
204968|NCT00537771|"     The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20     mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.      The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20     mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test,     and time to treatment failure.   "
204969|NCT00537784|"     People operated for a rupture of the Achilles tendon receive a concentrate of their own     platelets injected into the operated area. The study is randomized and single-blinded, with     20 treated patients and 20 controls, who get no injection. The primary endpoint is a     mechanical property of the tendon after 12 weeks (modulus of elasticity), as measured by a     special type of radiography. This radiography uses 0.8 mm metal markers, which are injected     into the tendon. The tendon is mechanically loaded during radiography and its strain can be     measured as increased distance between the markers. Other mechanical variables at 6, 12 and     52 weeks are secondary variables, as well as a validated patient-administrated questionaire     at 1 year.   "
204970|NCT00537797|"     The main purpose of this study is to see how well FDG-PET scans can determine the malignancy     of thyroid nodules that have already been tested (and come back positive) by fine needle     aspiration.   "
204971|NCT00537810|"     This study will test the effectiveness of two empirically-supported but distinct treatments     for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure     self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy     for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered     alone and in combination in a primary care setting.   "
204972|NCT00537823|"     The purpose of this study is to determine the effect of short-duration pre-operative FOLFOX     based therapy on postoperative problems after liver surgery for patients with metastatic     colorectal cancer.   "
204973|NCT00537836|"     The primary goal of the planned study is to investigate the efficacy and safety of ZK 283197     in the dosage of 2 and 3 mg ingested once daily during a period of 8 weeks for the treatment     of hot flushes. In order to be able to assess the efficacy of the test substance, this is     compared with the efficacy of 1 mg Estradiol and placebo. The comparator Estradiol is a     certified hormone preparation, which is already used for the treatment of hot flushes as     standard treatment. After passing the screening, volunteers will start with a run-in phase     followed by a 8 weeks treatment and a follow-up phase. 112 postmenopausal women with hot     flushes and without relevant prior diseases will participate in three European countries (2     study sites in Germany, 1 study site in Great Britain and 1 study site in The Netherlands) in     this study.   "
204974|NCT00537849|"     An investigational study on the use of HIFU in the management of localized prostate cancer as     a primary non-comparative study      High intensity focused ultrasound (HIFU) is a non-invasive acoustic ablation technique that     uses intersecting, precision focused ultrasound waves to raise the temperature of the target     to )80-90 degrees C in 2-3 seconds, destroying the targeted tissues (prostate cancer). The     tissue targeting is highly precise, minimizing collateral damage.      The overall hypothesis is that HIFU with Sonablate can safely, effectively and selectively     ablate prostate cancer tissue, resulting in complete tissue necrosis, in patients diagnosed     with localized T1c/T2a prostate cancer, with minimal morbidity.      The specific hypothesis is that the Sonablate has the ability to:        -  COmpletely destroy prostate cancer tissue, without causing damage to the intervening          tissue, with a drop in PSA levels to <0.5ng/ml.        -  Result in negative biopsies for evidence of viable malignant cells after the          treatment(12 months if Nadir is not reached or PSA rises from Nadir)        -  Safely treat localized prostate cancer pts., with minimal and acceptable adverse          effects.   "
204975|NCT00537862|"     This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium     (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney     transplant recipients   "
204976|NCT00537875|"     The purpose of this study is to determine whether powdered ginger root (encapsulated ginger)     is effective for reducing the frequency, duration and severity of both acute and delayed     nausea and vomiting.   "
205719|NCT00535041|"     Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite     surgery in patients with localized rectal CA   "
204977|NCT00537888|"     The definition of pulmonary candidiasis is still unclear.In China, isolation of candida spp.     form sputum twice or three times a week has been regarded as the microbiological evidence of     pulmonary candidiasis. The investigators hypothesize that patients who present respiratory     symptoms and lung infiltrates together with smear of culture positive for candida spp. from     sputum three times a week can not be diagnosed as pulmonary candidiasis.   "
204978|NCT00537901|"     First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum   "
204979|NCT00537914|"     This study is performed to investigate the long-term safety, in particular the diabetogenic     potential and immunogenicity of rhGH therapy in short children born small for gestational age     (SGA).   "
204980|NCT00537927|"     Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might     influence the degree of postoperative pain.      The study hypothesis is that there is no difference in postoperative pain between different     methods to fix the mesh in laparoscopic incisional / ventral hernia repair.   "
204981|NCT00537940|"     To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with     partial seizures.   "
204982|NCT00537953|"     The combination of a half-course of miltefosine and a half-course of antimony will be     evaluated for efficacy and tolerance. The combination of miltefosine and antimony is chosen     because these are now the two standard agents in Bolivia, and in vitro the combination was     additive to mildly synergistic against a standard leishmania strain.   "
204983|NCT00537966|"     Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of     early antiretroviral treatment and investigate early events of virus-host interactions in     patients with documented acute or recent HIV-1 infection in Zurich.      Study design: This is an open label, non-randomized, observational, single center study at     the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We     aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill     the inclusion criteria of a documented acute or recent HIV infection can participate in the     study. Patients are offered early combination antiretroviral treatment (cART), if treatment     start falls within 90 days after diagnosis of acute HIV-infection. After one year of     suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who     have not chosen to undergo early-cART, respectively will stop cART after one year will be     followed for a total of 5 years. Viral setpoints reached after treatment interruptions will     be compared to historic controls and to the control group not having received cART during     acute infection. A battery of virological and immunological assays will be performed on blood     samples obtained to better understand early virus-host interactions, which are thought to     play a key role in HIV-pathogenesis research.      Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection     with regard to epidemiology, impact of early-cART on the course of disease and forms the base     for a variety of translational research projects addressing early key pathogenesis events     between virus and host, relevant for the course of disease, for transmission, for development     of vaccines and new treatment strategies.        -  Trial with medicinal product   "
204984|NCT00537979|"     Prospective, non-randomized, multi-center study to assess the efficacy and safety of     paricalcitol injection or oral administered over 6 months to patients with secondary     hyperparathyroidism on dialysis.   "
204985|NCT00537992|"     Although commonly used in cataract surgery, the use of the blue light-filter IOLs in     vitrectomy combined with cataract surgery has not been reported yet. A prospective controlled     clinical trial was designed to evaluate the effect of the blue light-filter IOL on the     surgeon's ability to perform specific vitreoretinal procedures and on the patients' outcome.   "
204986|NCT00538005|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of malignant melanoma by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving sorafenib together with     bevacizumab and oxaliplatin may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side-effects and best dose of sorafenib when     given together with bevacizumab and oxaliplatin and to see how well it works in treating     patients with metastatic malignant melanoma.   "
204987|NCT00538018|"     Demonstrate efficacy of telithromycin over single-agent oral antibiotics usually prescribed     by local guidelines (usual care) for treating adult outpatients with mild to moderate     community-acquired pneumonia (CAP) in high bacterial resistance areas.   "
204988|NCT00538031|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Giving cyclophosphamide together with celecoxib may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide together     with celecoxib works compared to cyclophosphamide alone in treating patients with recurrent     or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer.   "
204989|NCT00538044|"     we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to     congenital heart disease or chronic pulmonary embolism before and after the operation.   "
204990|NCT00538057|"     A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is     being developed for once daily administration for the maintenance treatment of asthma and     COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and     compared with GW642444M and GW685698X administered separately in order to determine whether     co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics     of either compound.   "
205003|NCT00538226|"     This is an open label pilot study to evaluate the efficacy and the safety of the Flowaid     device in increasing local circulation in the legs.      15 patients with a diagnosis of Peripheral Vascular Disease will be enrolled in this study.     They will recieve tratment with the Flowaid device and monitored continuously by means of     Laser Doppler Flowmetry as well as by tcPO2 and Digital Thermography. Subjective data will     also be collected.   "
204991|NCT00538070|"     The NMDA receptor has been identified as having a role in substance use disorders as well as     in schizophrenia. One example of the former is nicotine's effect on dopaminergic activity not     only by increasing the release of dopamine in the Midbrain reward centers, but also through     less direct mechanisms affecting alpha-7 nicotinic receptors, NMDA receptors, and Glycine, a     co-agonist for the NMDA receptors. In terms of schizophrenia, it has been hypothesized that     NMDA receptor hypofunction plays a role in the mechanism for negative symptoms and cognitive     dysfunction in these patients. The NMDA hypofunction may be reversed with increased synaptic     glycine availability.      Sarcosine, or n-methyl-glycine, is a GlyT-1 and System A transport inhibitor actions which     could be expected to increase the availability of glycine, in the synaptic space. Sarcosine     is a dietary supplement which could be found in several food items such as egg yolks and     turkey.      Our collaborative team has developed a novel, non-invasive magnetic resonance spectroscopy     (MRS) technique for measuring brain glycine changes that allows us to study glycine     homeostasis. The purpose of this study is to explore the effect of sarcosine     (n-methyl-glycine) on brain glycine concentrations. It is our hypothesis that oral sarcosine,     at a dose of 2 grams per day, will be well tolerated and associated with increased brain     glycine concentrations. It is our secondary exploratory hypothesis that increases in brain     glycine will be associated with behavioral signs of increased NMDA and dopamine activity.     This modulation could have future therapeutic potential for disorders of hedonic and     cognitive function.   "
204992|NCT00538083|"     Cardiovascular disease is the leading cause of death in the United States. Studies have shown     that obesity is an important risk factor for development of cardiovascular disease.     Endothelial dysfunction, a pathologic feature of obesity, predicts the occurrence of     cardiovascular disease. Recent research findings indicate that consumption of cocoa exerts     cardioprotective effects, which include increasing HDL levels, reduction in systolic BP,     inhibition of platelet aggregation/activity and activation of endothelial nitric oxide     synthase.      Proposed is a randomized controlled trial consisting of 4 phases designed to examine the     dose-response, and the acute and sustained effects of cocoa consumption on endothelial     function as a marker of cardiovascular disease risk in 45 otherwise healthy adults with a BMI     25-35kg/m2.   "
204993|NCT00538096|"     -  Evaluate the safety and tolerability of multiple doses of MEDI-538 by continuous IV          infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative          therapy.        -  Determine the maximum tolerated dose of MEDI-538 administered by continuous IV infusion.   "
204994|NCT00538109|"     An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients with     Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast     Crisis, Accelerated Phase or Chronic Phase   "
204995|NCT00538122|"     This study is being done to look at the electrical activity of the heart. This study will     help decide whether taking recordings for a 24-hour period gives more useful information than     recording it for a few seconds in a doctor's office. The study will compare 24 hour     electrocardiogram (ECG) results of patients taking thioridazine (Mellaril) to those of other     patients taking different medications that took part in another study.   "
204996|NCT00538135|"     The aim of the study was to investigate if the addition of cognitive behavioural therapy to     treatment as usual (CBT plus TAU) in participants with borderline personality disorder would     decrease the number of participants with emergency (i.e. unplanned) psychiatric or accident     and emergency room contact or episode of deliberate self-harm over twelve months treatment     and twelve months follow-up, compared with treatment as usual (TAU). The study also examined     whether CBT plus TAU would lead to superior improvement in quality of life, social, cognitive     and mental health functioning than TAU alone.   "
204997|NCT00538148|"     Non-inferiority efficacy of telithromycin versus azithromycin   "
204998|NCT00538161|"     We propose that as low tidal volume ventilation has proven to be beneficial in patients with     established ARDS it may have a role in preventing the onset of acute lung injury in the     cardiac surgical population. Institution of low tidal volume ventilation in the operating     room may reduce the release of the cytokines and interleukins that have been known to     contribute to the development of acute lung injury. In this study, we propose that the     institution of low tidal volume ventilation in the operating room will reduce the incidence     of acute lung injury. Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours     post operatively will help determine if there is a difference in oxygenation between the two     groups. Chest X-ray findings, time to extubation and length of ICU stay will also determine     if there is a role for low tidal volume ventilation in the operating room. We will also     attempt to establish a causative mechanism by measuring plasma levels of cytokines known to     be associated with the development of ARDS.   "
204999|NCT00538174|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and     pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin     in diabetic Japanese subjects administered for 14 days   "
205000|NCT00538187|"     Obatoclax may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer.     Bortezomib and obatoclax may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Giving obatoclax together with bortezomib may kill more cancer cells.     This phase I/II trial is studying the side effects and best dose of obatoclax when given     together with bortezomib and to see how well they work in treating patients with aggressive     relapsed or recurrent non-Hodgkin lymphoma.   "
205001|NCT00538200|"     The purpose of this study is to determine the best form of dietary intervention to     undernourished individuals with COPD.      The research aims to test the null hypothesis that there is no difference between oral     nutritional supplements and dietary advice.   "
205002|NCT00538213|"     Since influenza vaccines are administered every year because of the frequent change in their     antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza     vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study,     the subjects previously enrolled in study 104887 will receive a dose with the 2007-2008     season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in     study 104887 are eligible for participation in this study.   "
205053|NCT00525512|"     The objective of this study is to evaluate the effects on exercise duration of 96 weeks     treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in     patients with COPD.   "
205004|NCT00538239|"     The purpose of this study is to determine whether maintenance therapy with oral AP23573     (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in     patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result     in clinically significant improvement in progression-free survival as compared to oral     placebo.   "
205005|NCT00538252|"     Parental involvement has been shown to be a robust predictor of child conduct problems (CP)     and drug use risk in childhood and adolescence, but relatively little attention has been paid     to the role of parental involvement in relation to child problem behavior during the     transition to school-age, when children are spending more time in school, after-care     settings, and in the neighborhood. Concomitantly, as children transition from preschool to     school-age, there is evidence to suggest that the quality and organization of schools,     after-school care, and neighborhoods play an increasingly important role in the emergence of     children's CP and drug use risk. Specifically, we will address: 1) the extent to which the     quality of school environments, after-school care, and neighborhoods are associated with the     emergence of CP during the early school-age period; 2) how parental involvement in the     toddler and preschool period may be associated with parental involvement and monitoring in     extra-familial contexts in the early school-age years; 3) how parental involvement in     schools, after-care, and the neighborhood, may moderate relationships between extra-familial     factors and children's CP; and 4) whether a parenting intervention can increase parental     involvement in school, after-care, and neighborhood contexts and decrease risk of children's     subsequent CP. These issues will be tested with an existing sample of 731 ethnically-diverse     children from urban, suburban, and rural sites. As all families in the study were recruited     based on the presence of sociodemographic, family, and child risk factors, the cohort of     children are at high risk for displaying a persistent trajectory of clinically-meaningful CP     and drug use risk. Thus, the study has the potential to fill a much-needed void on     associations between extra-familial contexts and risk for early-starting CP and later problem     behavior during the early school-age years. Equally critical, the study can provide data on     the potential moderating influence of involved parenting, its malleability for families     facing multiple adversities, and whether family-based interventions can make a difference for     children facing multiple adversities.   "
205006|NCT00538265|"     An open-label randomized multicenter clinical study comparing three regimes of     immunosuppression : (A) tacrolimus and steroids, (B) antithymocyte induction therapy and full     dose of tacrolimus, (C) antithymocyte induction therapy with mycophenolate mofetil and a     reduced dose of tacrolimus.   "
205007|NCT00538278|"     Prospective Database for Acute Myeloblastic Leukemia   "
205008|NCT00538291|"     RATIONALE: Monoclonal antibodies such as cetuximab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of     colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as     capecitabine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving cetuximab together with capecitabine may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with capecitabine     work in treating patients with metastatic colorectal cancer.   "
205009|NCT00538304|"     A one month study which will determine the safety and efficacy of bimatoprost eye drops in     patients with glaucoma or ocular hypertension   "
205010|NCT00538317|"     In patients with acute myocardial infarction who are managed in the prehospital setting, and     who will treated with primary angioplasty, we evaluate the benefit of an early administration     of tirofiban, a powerful GPIIbIIIa inhibitors. Patients are randomised to early     administration in the ambulance or administration in the cathlab. The primary endpoint is     TIMI 2-3 flow in the first coronary opacification of the culprit artery.   "
205011|NCT00538330|"     Post operative adjuvant chemotherapy followed by adjuvant Tamoxifen vs nil for patients with     operable breast cancer   "
205012|NCT00538343|"     The purpose of this study is to determine whether RTA 744 is effective in the treatment of     breast cancer that has metastasized to the brain.   "
205013|NCT00538356|"     Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct     trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate     variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK     active implants has the potential to detect some of these trends early and thus to offer the     possibility to intervene in time for prevention of fatal worsening of heart failure.      To investigate the predictive value of Home Monitoring parameters, patients with symptomatic     heart failure and reduced ejection fraction receiving an implantable     cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization     therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring     analysis or standard care. The influence of Home Monitoring on the clinical status of heart     failure patients will be assessed.   "
205014|NCT00538369|"     When a physiologic tool to measure the patient's hypnotic state is added to current practice     tools is there a decrease in the amount of drug the patient receives.   "
205015|NCT00538382|"     The objective of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD)     of a standard dose of orally administered artesunate, in order to determine if the current     adult dose (200 mg) is appropriate in parasitemic pregnant women when compared to the same     women at three months postpartum and to parasitemic non-pregnant women. Preliminary evidence     on safety, tolerability and efficacy will be gathered.   "
205016|NCT00538395|"     Intensive sequential chemotherapy with Adriamycin Taxol and Cytoxan in the treatment of     locally advanced breast cancer   "
205017|NCT00538408|"     To investigate the diagnostic performance of whole body magnetic resonance angiography     (WB-MRA) using two different magnetic resonance contrast agents.   "
205018|NCT00538421|"     Comparing 2 different anaesthetic methods during abdominal aortic aneurysm surgery. The     patients will be followed up 30 days postoperative. Number of patients included will be 200.     Perioperative details will be analyzed.   "
205019|NCT00538434|"     This trial will study three doses of reslizumab versus placebo in children with eosinophilic     esophagitis (EE). The objectives of the trial will be to study the effectiveness of     reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils     as well as assessing the safety profile compared to placebo.   "
205020|NCT00538447|"     Prospective Database for Chronic Myelogenous Leukemia   "
205021|NCT00538460|"     This study is designed to evaluate the effectiveness and measurable cost impact of stress     cardiac MRI for non-invasive evaluation of intermediate lesions discovered on CCTA in     low-to-intermediate risk patients admitted to the ED with suspected ACS. Our primary     objective is to determine if the strategy of CTA + stress CMR will reduce the length of time     in the ED required to establish a definitive diagnosis, compared to CTA + stress MPI.   "
205109|NCT00526253|"     This study injects a person's own stem cells into heart muscle tissue after a person has one     or more heart attacks. The purpose of the study is whether the stem cells will improve a     patient's heart performance.   "
205022|NCT00538473|"     Since influenza vaccines are administered every year because of the frequent change in their     antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza     vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study,     the subjects previously enrolled in study 107973 will receive a dose with the 2007-2008     season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in     study 107973 (NCT00386113) are eligible for participation in this study.   "
205023|NCT00538486|"     The epidemic of obesity is associated with a considerable rise in the incidence of the     metabolic syndrome, type 2 diabetes mellitus, and hypertension. Insulin resistance plays an     important role in the pathogenesis of obesity related hypertension. These patients are at     high risk to suffer from cardiovascular events. However, current guidelines for treatment of     hypertension do not provide specific recommendation for the pharmacotherapy of obese     hypertensive patients due to lack of prospective randomized intervention studies in     non-diabetic obese hypertensive patients.      Aside from their antihypertensive effects, angiotensin II receptor blockers (ARB) were shown     to improve insulin sensitivity. Furthermore, metformin is commonly used to treat the obese     type 2 diabetes mellitus. Metformin can also lower body weight and increase insulin     sensitivity. In a prospective, double-blind, double-dummy, randomized, parallel-group study,     we will evaluate the effects of ARB (telmisartan and candesartan) or amlodipine combination     with metformin on weight gain, visceral fat, and metabolic parameters in obese hypertensive     patients without diabetes mellitus compared with obese hypertensives on ARB or amlodipine     treatment alone. This study will help to develop future comprehensive treatment strategies     and guidelines for obesity related hypertension.   "
205024|NCT00538499|"     RATIONALE: Patient-controlled analgesia using fentanyl and bupivacaine may lessen pain caused     by video-assisted chest surgery. Giving bupivacaine in different ways may give better pain     relief.      PURPOSE: Thisrandomized clinical trial is comparing three different ways to give bupivacaine     together with fentanyl to see how well they work in reducing pain after video-assisted chest     surgery.   "
205025|NCT00538512|"     The purpose of this study is to evaluate the absolute (versus placebo) and relative (one     vaccine compared to the other) efficacies of the live attenuated and inactivated influenza     vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating     strains whether similar or dissimilar to strains included in the vaccines.   "
205026|NCT00538525|"     Phase II study of neoadjuvant chemotherapy with Doxorubicin followed by Docetaxel-Cisplatin     in locally advanced breast cancer   "
205027|NCT00538538|"     Visual outcomes of the eye with large subretinal hemorrhages (bleeding under the retina) due     to Age-Related Macular Degeneration (AMD) are poor. The Submacular Surgery Trial (SST) showed     that no statistically significant improvement in vision resulted from surgical removal of the     layer of abnormal blood vessels causing the bleeding. However, placement of a gas bubble into     the gel of the eye along with removal of the blood has shown some success. However, this does     not treat the underlying condition of the AMD.      Intravitreal injections (into the gel of the eye) of a drug called Lucentis has been shown to     be highly effective in the treatment of AMD, yet its penetration through areas of thick blood     caused by subretinal hemorrhage is not known.      This study is proposing to treat the AMD causing the subretinal hemorrhage with a vitrectomy     (surgery involving removing the gel inside the eye, and membrane layers of the eye) followed     by Lucentis placed between the layers of the retina and then with or without a gas bubble.      In order to determine if the the subretinal Lucentis alone is beneficial, 5 of the 10     patients enrolled will get a gas bubble and the other 5 will not.   "
205028|NCT00538551|"     Prospective Data Collection of Newly Diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma     Cases   "
205029|NCT00538564|"     This research is being done to compare the effect of tadalafil with placebo (an inactive     substance that looks like the study drug, but should have no effect) on the frequency of     recurrent priapism (prolonged erection, unassociated with sexual interest or desire) and the     nature of sexual experiences in male patients with sickle cell disease.   "
205030|NCT00538577|"     Soft tissue necrotizing fasciitis of limbs are lethal infections and associated with high     morbidity and mortality rates. The purpose of this study is to determine the clinical     manifestations and factors affected the treatment outcome to predict the prognosis and make     timely decision for appropriate management and prevent limb loss.   "
205031|NCT00538590|"     To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation     and Mitomycin-C(MMC) in glaucoma surgery.   "
205032|NCT00538603|"     Multi-national, randomized, phase III, GCIG Intergroup study comparing pegylated liposomal     Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in patients with     epithelial ovarian cancer in late relapse. (CALYPSO)   "
205033|NCT00538616|"     The purpose of this study is to evaluate brain injury when two different drugs (propofol and     precedex) are used to sedate patients who need a neurologic exam.   "
205034|NCT00538629|"     Investigation of the impact of Zeldox on metabolic parameters in patients with bipolar     disorder or with schizophrenia and the impact of the treatment with quality of life.   "
205035|NCT00538642|"     Having a diagnosis of schizophrenia or bipolar disorder and being treated with certain of the     newer antipsychotics are risk factors for development of diabetes. Subjects with these risk     factors plus obesity and/or family history of diabetes who agree to study participation will     undergo an oral glucose tolerance test. If the oral glucose tolerance test demonstrates that     the subject is pre-diabetic (elevated glucose levels, but below the diabetic range), he/she     will have his/her insulin resistance level measured, prior to random assignment to either     stay on current antipsychotic medication or switch to ziprasidone. Insulin resistance will be     measured again after four months. The primary hypothesis is that insulin resistance will     decrease in those switched to ziprasidone relative to those continuing on their same     antipsychotic medication.   "
205051|NCT00525486|"     To evaluate the treatment efficacy and safety usig extended release nifedipine, as     maintenance therapy to pregnant women who were hospitalized and treated for preterm labor     until 34 weeks' gestation. After the PTL will stop, we will randomize these women for the     treatment group and the control (no treatment) group.      The main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome     will be the side effects of the medication and the newborn/mother health variables.   "
205036|NCT00538655|"     Patients treated for methamphetamine dependence have high rates of relapse, and no     pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d,     l-2-[(diphenylmethyl) sulfinyl] acetamide) is a novel wake- and vigilance- promoting agent     that is chemically and pharmacologically dissimilar to CNS stimulants such as the     amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability     compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may     relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to     reduce cocaine use in dependent users, and is safe when co-administered with intravenous     methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish     its safety and efficacy as a pharmacotherapy for methamphetamine dependence.      Specific Aims:        1. Determine the safety of modafinil in the treatment of methamphetamine dependence.        2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence.        3. Assess the effect of modafinil on cognitive function in methamphetamine users.        4. Assess the effect of modafinil on methamphetamine withdrawal symptoms.        5. Compare the validity of a cellular telephone-based reporting system for assessing          medication regimen adherence to conventional electronic medication monitoring.      Hypotheses:        1. Modafinil will be as safe and well tolerated as placebo in a comparison group from          another study.        2. Subjects given modafinil will use less methamphetamine than subjects given placebo.        3. Subjects given modafinil with demonstrate improvements in cognitive function when          compared to subjects given placebo.        4. Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects          given placebo.        5. Adherence will be recorded more accurately by cellular telephone than by conventional          electronic medication monitoring.   "
205037|NCT00538668|"     The purpose of this study is to test the safety of the experimental drug, 177Lu-J591 and see     what effects (good and bad) it has on your prostate cancer. Another purpose is to find the     highest dose of the drug that can be given without causing severe side effects.   "
205038|NCT00525317|"     This is a trial of treatment with tablets containing magnesium for leg cramps in pregnancy.   "
205039|NCT00525330|"     To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor,     in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how     much of the HbA1c response is attributable to nocturnal coverage will be explored.   "
205040|NCT00525343|"     The Avonex Fifteen-year Long-term Follow-up of Patients with Relapsing Multiple Sclerosis:     ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs (ASSURANCE), was a     single-time-point evaluation of patients conducted 15 years after the pivotal MSCRG study,     evaluated the impact of IM IFNβ-1a treatment on long-term disability and Quality of Life     outcomes in patients who completed 2 years in a previous Multiple Sclerosis Collaborative     Research Group (MSCRG) study.   "
205041|NCT00525356|"     The objective of this study is to compare treatment with an endograft prothesis versus     antihypertensive treatment in patients with a dissection of the thoracic aorta.   "
205042|NCT00525369|"     In a equivalence analysis, we determined whether IL-6 can be assessed using a new     densitometric point-of-care (POC) assay (turn-around -time: 20 minutes).IL-6 measurements     were compared to test results obtained with conventional ELISA analysis   "
205043|NCT00525382|"     Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic     Idiopathic Urticaria.   "
205044|NCT00525395|"     Background      Phototherapy UVB TL01 currently represents the first choice in treatment to induce the     repigmentation of vitiligo spots. The problem though is that there are no systems or scales     which enable an objective evaluation of the therapy, commonly known as percentage of     repigmentation.      Recently, a European Task Force (VETF, Vitiligo European Task Force) of experts on vitiligo,     within the European Society of Pigmentation, has proposed a gravity classification on the     basis of three parameters/standards - extension, progression and the level of depigmentation     - and used to classify patients in ten European centres. The aim of the trial is to validate     the VETF scoring system set up in relation with the therapeutic answer to the standard     treatment for vitiligo and phototherapy.      Leaving aside short term side effects, such as sunrush/erythema and sunburn, which are     reversible and infrequent, the main problem with phototherapy is represented by the     cumulative long term effects of ultraviolet rays. These can cause premature ageing of the     skin (photoaging) and the appearance of skin cancer/neoplasia. Therefore the aim is to get     the best results from phototherapy whilst limiting its length.      Aims of the trial:        1. To validate the VETF scoring system. As phototherapy is currently the only universally          accepted treatment for vitiligo, it seems logical to test the VETF scoring system first          to evaluate the effectiveness of phototherapy.        2. Secondly, the target of this multicentric trial is to compare the effectiveness of two          different phototherapy protocols; a first protocol foresees non-stop treatment for 6          months; a second protocol foresees periods of interruption during the treatment. This          will help to verify whether interrupting a cycle of phototherapy is useful or not.      This interruption might make the ultraviolet rays more effective 'stimulus on the     melanocytes', and may also reduce long term damage caused by phototherapy.   "
205045|NCT00525408|"     This study proposed the comparison the overall survival, hematological toxicity, pain     reduction score,PSA levels, tumor response, quality of life in two arms of HRPC patients from     different parts of India.   "
205046|NCT00525421|"     A phase 2 randomized, placebo-controlled, double-blind trial of a two week course of     curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with     OLP presenting to the oral medicine clinic at the University of California, San Francisco,     will be enrolled. Study subjects will be randomized to receive either placebo or curcuminoids     6000mg/day for 2 weeks in three divided doses of 2000mg three times/day. Measurement of     signs, symptoms, periodontal status and blood tests including complete blood count, liver     enzymes, serum c reactive protein and serum interleukin-6 levels will be done at baseline and     at the end of 2 weeks. A side-effects questionnaire will be administered at the 2-week     follow-up.      The Numeric Rating Scale (NRS) will be used to measure symptoms and the Modified Oral     Mucositis Index (MOMI) to measure clinical signs of OLP. Primary outcome is change in     symptoms from baseline. Secondary outcomes are change in clinical signs, occurrence of     side-effects, change in serum C-reactive protein and serum interleukin-6 levels.   "
205047|NCT00525434|"     The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB     system for excisional biopsy wounds closure   "
205048|NCT00525447|"     This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a     regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with     relapsed multiple myeloma.   "
205049|NCT00525460|"     The purpose of this study is to ask youn women diagnosed with ovarian cancer who have     undergone surgery that will allow them to have children in the future, on issues such as:     education about their options to keep their ability to have children, after-chemotherapy     treatment decision making, and reproductive history. The second purpose is to determine the     effect of an early diagnosis of ovarian cancer on the sexual functioning of women.   "
205050|NCT00525473|"     Azathioprine (AZA) has long been used in dermatology in treating autoimmune bullous     dermatoses and generalized eczematous disorders as well as some photodermatoses. Its     metabolic process inside human body and its side effects relies on genetic polymorphism of     some enzymes such as thiopurine s-methyltransferase (TPMT) and inosine triphosphate     pyrophosphatase gene (ITPA). This study aims to analyze the relative contribution of TMPT and     ITPA mutations to the development of toxicity induced by AZA treatment and to detect the     correlation of the genetic polymorphism.   "
205052|NCT00525499|"     The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating     acne.   "
205054|NCT00525525|"     This is a phase II study of Bevacizumab plus Temodar and Tarceva in patients with     non-progressive glioblastoma or gliosarcoma. Patients must have stable disease immediately     following a standard course of up-front radiotherapy and Temodar. All patients will receive     Bevacizumab, Temodar and Tarceva. A total of 60 patients will be enrolled. Our hypothesis is     that the combination of Bevacizumab plus Temodar and Tarceva will increase survival over that     seen in historical controls who have newly diagnosed, non-progressive glioblastoma or     gliosarcoma following radiotherapy plus Temodar and use Temodar alone.   "
205055|NCT00525538|"     The purpose of this study is comparision conformal radiotherapy for gynecologic cancer   "
205056|NCT00525551|"     In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds     cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is     usually treated by an operation where the bone is replaced by a prosthesis. This restores     hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller     effect at high frequencies is probably caused by surgically induced inner ear damage.      Animal studies have shown that the drug acetylcysteine can protect the inner ear against     damage. It is not known whether the drug has similar effects in humans. This study will     assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.   "
205057|NCT00525564|"     This study was designed to test the following hypothesis:      The acute changes in exercise tolerance during the endurance shuttle walk will be greater     with salmeterol compared to placebo in patients with chronic obstructive pulmonary disease.   "
205058|NCT00525577|"     This double-blind, placebo-controlled, dose-finding study is designed to identify the lowest     AGI-1067 dose that improves glycemic control as measured by HbA1c and fasting glucose in     subjects with Type 2 diabetes mellitus. Glycemic control will be measured during a 6-month     treatment period in subjects who are on 1 or no antidiabetic drugs   "
205059|NCT00525590|"     The purpose of this study is to determine the effect of the surgical intervention and     insertion of GLIADEL wafers on the neurocognitive functioning in patients with metastatic     brain cancer.   "
205060|NCT00525603|"     Primary Objective:      1. Evaluate the ability of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR)     to increase the proportion of patients with <5% CD5/CD19+ cells in bone marrow to 66%     following 3 courses of treatment without significantly increasing the incidence of pneumonia     or sepsis compared to a historic group of patients treated with the combination fludarabine,     cyclophosphamide, and rituximab (FCR).      Second Objectives:        1. Assess complete remission (CR), nodular partial remission (nPR), and partial remission          (PR) rates (overall response) in high-risk, previously untreated patients with CLL          treated with CFAR.        2. Evaluate molecular remission in bone marrow by polymerase chain reaction (PCR) for the          clonal immunoglobulin heavy chain variable gene in responders treated with CFAR.        3. Assess immune parameters including blood T cell counts and subset distribution and serum          immunoglobulin levels pretreatment, during treatment, and post-treatment in patients          treated with CFAR.   "
205061|NCT00525616|"     The aim of the study is to assess that it will be possible to control with a single cycle of     rituximab patient with bullous pemphigoid.   "
205062|NCT00525629|"     Walnuts include many potentially beneficial micronutrients and phytochemicals, in this study     we propose to examine the effects of walnuts independent of macronutrient content. The     purpose of this proposal is to study in depth the short-term effects of walnut consumption in     men and women with the metabolic syndrome.      Study Aim 1: To investigate the effects of walnuts (48gms per day over 3 days) on insulin     resistance in subjects with the metabolic syndrome.      Study Aim 2: To investigate the effects of 48gms per day of walnuts over 3 days on lipids and     inflammatory markers.      Study Aim 3: To assess the possible mechanisms of the biological effects of short-term walnut     consumption through assessment of adipokines, resting metabolic rate, gene expression in     white blood cells and the effect of walnuts when consumed as part of a mixed meal, on glucose     excursions, insulin secretion and the excretion of gut peptides and free fatty acids.   "
205063|NCT00525642|"     Anthracycline based regimens followed by a taxane (CALGB-9344 trial and NSABP-B28) or     reversed (MD Anderson Adjuvant Trial) has already accepted as adjuvant therapy for node     positive breast cancer. Also in this group of patients, data from BCIRG-001 trial had shown     that six cycles of adjuvant TAC (docetaxel, doxorubicin and cyclophosphamide) is superior to     standard FAC (5-FU, doxorubicin and cyclophosphamide ) combination in terms of both disease     free and overall survival, while associated with a higher rate of febrile neutropenia. Then     question arose whether it is better to use docetaxel and anthracycline in combination or     sequence.   "
205064|NCT00525655|"     The goal of this research study is to test the first version of a website that will offer     information and support for adolescents and young adults with FAP. Researchers want to see if     the website will be helpful, easy to understand, and easy to use for young patients with FAP.   "
205065|NCT00525668|"     Hypothesis:      Sunphenon, a green tea extract containing 95% egcg, given daily as oral medication over a     period of 18 months has anti-inflammatory and neuroprotective properties in patients with     relapsing-remitting multiple sclerosis as assessed by magnetic resonance imaging and clinical     examination (EDSS and MSFC).   "
205066|NCT00525681|"     The major cause of premature death in renal transplant recipients is cardio-vascular disease.     In addition, obesity is becoming a major problem in this patient population. Rimonabant does     not only seem to have weight reducing properties but also weight reduction independent     effects on insulin sensitivity and endothelial function, two important cardio-vascular risk     factors. Rimonabant therefore is an interesting drug for the treatment of transplanted     patients. Present data also indicate that rimonabant does not interact with essential     immunosuppressive drugs (CsA and Tac) indicating that it most probably is safe to administer     to this patient population. However this needs to be investigated in a proper manner.   "
205092|NCT00526019|"     This study aims at determining the patterns of asthma remission, the prevalence of these     different patterns, the various factors associated with such remissions and possible     recurrences of asthma, in order to determine the mechanisms involved in these processes.      The investigators therefore want to document these specificities in subjects in complete     remission of their asthma, and those in only symptomatic remission of their asthma, in     comparison with mildly symptomatic asthmatic subjects and healthy controls.   "
205067|NCT00525694|"     This will be a clinical test to determine if any carbohydrate or a gluconeogenic precursor     added to a zero calorie product might be important to consider in the management of obesity,     metabolic syndrome and diabetes mellitus. This research trial will evaluate the effect of     three different solutions on blood glucose level. One solution is plain water, the second a     standard high glucose (sugar) solution used typically in diabetes testing, and the third a     low calorie drink (Zero Coke). Based on a prior study evaluating a diet for effective weight     loss, we observed that patients who drank large volumes of diet soda did not lose weight as     readily as those who did not drink diet soda. Therefore, we propose to examine the actual     effect of one diet soda (Zero Coke) on the body's glucose level and compare it to water and a     high glucose solution. All participants in this study must have 3 Glucose tolerance     evaluations - one with each solution: water, high glucose, and Zero Coke.   "
205068|NCT00525707|"     The randomized patients with acute heart failure will be stratified based on the presence or     absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the     first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of     the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days     after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up     period of 5 months for vital status.   "
205069|NCT00525720|"     The goal of this clinical research study is to learn if a prostate implant (brachytherapy)     can help to control intermediate risk prostate cancer. The safety of this procedure will also     be studied.      Prostate brachytherapy is performed by inserting permanent seeds (which are radioactive     pellets) into your prostate in order to treat the prostate cancer with radiation therapy.   "
205070|NCT00525733|"     The researchers are involved in a phase II, randomized, two-arm study, comparing the     efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with     Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and     raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women.     Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the     investigator and patient that continued therapy is in the patient's best interest.      Hypotheses:        -  Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination          with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral          replication.        -  Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect          to immune reconstitution in peripheral blood and in the gastrointestinal mucosa.        -  Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with          respect to tolerability.   "
205071|NCT00525746|"     The goal of this research study is to identify biologic and lifestyle factors that may     increase a person's risk of developing acute myeloid leukemia or myelodysplastic syndrome     after treatment for a previous cancer (treatment-related AML/MDS).   "
205072|NCT00525759|"     There is clear preclinical in vitro and in vivo evidence of sequence dependent synergy     between chemotherapy agents and zoledronic acid. The aim of the study is to investigate if     the synergistic increase in tumour cell apoptosis observed in preclinical studies occurs in     patients. The hypothesis for this study is that there may be anti-tumour benefits of the     sequential application of chemotherapy agents followed by zoledronic acid in patients with     invasive breast cancer.   "
205073|NCT00525772|"     The purpose of this study is to study the effects of once daily inhaled ciclesonide at     varying doses on exercise provoked asthma symptoms, fall in lung function after exercise and     sputum characteristics.   "
205074|NCT00525785|"     The goal of this clinical research study is to learn if a combination of 5-FU, Folinic Acid     and Oxaliplatin, given with radiation therapy, is effective in the treatment of gastric or     gastroesophageal cancers that will be removed by surgery if possible. The safety of this     combination therapy will also be studied.   "
205075|NCT00525798|"     The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon     calcitonin in the treatment of patients with osteoporosis   "
205076|NCT00525811|"     Shared decision making (SDM) has been advocated as an appropriate approach for physician     patient communication. Positive effects of SDM are e.g higher patient satisfaction, greater     treatment adherence, lower decisional conflict and better clinical outcomes. The Section of     Clinical Epidemiology and Health Services Research at the University Medical Center in     Freiburg (Germany) is developing and evaluating a web-based interactive decision aid     (patient dialogue) to support shared decision making in cooperation with the Techniker     Krankenkasse, a large German health insurance company. Both development and evaluation are     conducted along the International Patient Decision Aid Standards (IPDAS).      The decision aid contains information on acute low back pain and depression and addresses     insurance members who are facing a treatment decision in one of the indications. It aims at     the development of patient competencies for participating in decision making, the support of     constructive health behavior and patients' acceptance of evidence based treatment options.      In an RCT the decision aid will be compared to a regular patient information on a sample of     N=500 patients in each group. Data collection will take place at three points of time: before     and after use of the decision aid as well as 3 months later.   "
205077|NCT00525824|"     The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or     Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low     Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary     Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of >20%   "
205078|NCT00525837|"     This study will assess whether varenicline (chantix) has antidepressant properties when used     in addition to other psychiatric medication. It will also assess whether varenicline improves     the inability to feel pleasure (i.e. anhedonia), and if it is well-tolerated when used with     psychiatric medications.      Enrolled patients will be assessed for improved mood, improved anhedonia, overall sense of     health, side effects as well as tobacco use for 6-8 weeks.      Medication will be provided free of charge.   "
205079|NCT00525850|"     To evaluate two different diets and their effects on weight loss and measurements of several     risk factors for cardiovascular disease. One diet will be a high saturated fat diet (HSFD)     and the other is a low saturated fat diet (LSFD) that limits fat but especially saturated fat     as red meat. All participants in this study must eat both diets as this is a randomized     cross-over design.   "
205080|NCT00525863|"     Due to intense ATP-consuming processes in the brain, a high level of brain energy supply is     required. A popular hypothesis regarding the pathogenesis and pathophysiology of     schizophrenia postulates hypofunction of neuronal circuits in the prefrontal and     limbic-temporal areas. An emerging body of data suggests that impaired energy metabolism due     to mitochondrial dysfunction plays a role in the pathophysiology of schizophrenia.      Under normal conditions cellular metabolic rate, i.e. oxygen and glucose consumption,     increases proportionally with any increase in neuronal activity. The impaired energy     metabolism due to mitochondrial dysfunction and frontal lobe hypofunction might be improved     by increasing O2 supply to the brain. Oxygen-enriched air inhalation has been shown to     increase brain oxygen supply. Hyperoxia therapy is a useful tool in the treatment of     neurological and neurotrauma deficits.      We therefore suggest a randomized double blind cross-over study of enriched inspired O2     partial pressure in schizophrenia.      It is surprising given the numerous findings on reduced energy metabolism in schizophrenia     that simple treatment with inspired enriched oxygen has not been studied.   "
205081|NCT00525876|"     1. To determine the safety and efficacy of non-myeloablative allogeneic stem cell          transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen          for patients with advanced or recurrent mantle cell lymphoma.        2. To determine factors associated with response and durable remission in patients          receiving rituximab, cyclophosphamide, and fludarabine in preparation for allogeneic          stem cell transplantation.   "
205082|NCT00525889|"     This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within     the previous 3-48 months. The study is testing whether two immune system modifying drugs are     safe when used in combination and if they have immune altering effects that indicate they can     halt the progression of type 1 diabetes progression.   "
205083|NCT00525902|"     The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.   "
205084|NCT00525915|"     The goal of this clinical research study is to learn if a combination of the investigational     drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is     as effective as a combination of these two drugs given before and during radiation therapy in     the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of     therapy will also be compared.      Objectives:      Primary objective:      Compare the Pathologic Complete Response rate and % of patients with <50% residual cancer in     the resected surgical specimen between Arms A and B.      Secondary objectives:        1. Compare 1-year and 3-year survival rates, median survival time, R0 resection rates,          safety, and local plus systemic relapse rates between Arms A and B        2. Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to          assess predictive markers of response and outcome.        3. Evaluate the joint effects, including possible interactive effects, of          proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates,          safety, and local plus systemic relapse rates.   "
205085|NCT00525928|"     This study of psychiatric inpatients will assess mood effects of varenicline, as well as     assess if varenicline decreased nicotine cravings acutely.      This study will also measure side effects of varenicline when given in addition to other     psychiatric and non-psychiatric medications.   "
205086|NCT00525941|"     NBI-34060 is an investigational (research) medication being studied in people with insomnia.     The current study is designed to evaluate how people, who experience a nighttime awakening     with difficulty returning to sleep, feel during the next day after dosing with NBI-34060. The     study will also examine the pattern and extent of nighttime awakenings as reported by the     patients, as well as and the patient's sleep experience during treatment.   "
205087|NCT00525954|"     The study will be conducted at up to 25 U.S. centers and will be a double-blind randomized     parallel group placebo controlled study among subjects with stable coronary artery disease     (CAD). Subjects will be randomized to receive either placebo tablets or one of 2 orally     active doses of A-002. The duration of study drug therapy will be 8 weeks.   "
205088|NCT00525967|"     The purpose of this study is to determine whether oral methadone plus acetaminophen can     substitute morphine in the treatment of cancer pain.   "
205089|NCT00525980|"     This project will build upon prior, successful research on the effectiveness of an     interactive computer disk with readable only memory (CD-ROM) for educating women about breast     cancer and genetic risk. Prior studies found that an interactive CD-ROM for educating women     about breast cancer risk and genetic testing was effective. The program was well received by     lay persons and professionals. In a randomized controlled trial conducted at multiple sites,     the CD-ROM intervention was highly effective in increasing knowledge, especially among women     at low risk of carrying a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation.      Researchers now propose to expand the use of the interactive CD-ROM in two innovative ways.     The overall goal of this proposal is to evaluate the program as a first-line educational     approach for Hispanic women on the Texas-Mexico border, where educational resources about     cancer genetics are limited. First, researchers will modify and adapt the program for a     primarily Hispanic population, in order to make it culturally and linguistically appropriate     to the needs of that audience.      Second, researchers will evaluate the program as a first-line educational method among women     with a personal or family history of breast cancer. Researchers will compare the     effectiveness of the CD-ROM when implemented with and without the guidance of a trained     promotora, and in comparison with standard educational materials (usual care condition).      The specific aims of this study include:      Aim 1: To modify the interactive CD-ROM to: a) make it culturally and linguistically     appropriate for Hispanic women residing along the Texas-Mexico border; b) reflect current     knowledge about breast cancer genetics; c) add a module to help women prepare to discuss     their family history and cancer risk with a health care provider (n=50 participants).      Aim 2: To conduct a randomized, controlled evaluation that compares the efficacy of the     modified CD-ROM when used alone vs. when used with a promotora-assisted approach vs. standard     written materials (n=414 participants).   "
205090|NCT00525993|"     The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be     non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in     sports. The investigators objective is to discuss the point that the investigators will     follow the minimal dose that is effective for the treatment of this acute condition in     orthopedic.   "
205091|NCT00526006|"     The acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of     treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is     of clinical significance. In a doubleblinded and placebocontrolled study healthy volunteers     are randomized to treatment with placebo or PPI + placebo. Gastrointestinal symptoms are     scored once a week and.   "
205107|NCT00526214|"     Primary:      Change of volume of perihematomal edema as assessed by brain CT.      Secondary:      The change of ICH volume between the initial and the follow-up CT scans The neurological     status at 90 day using E-GOS and mRS. The cumulative incidence of major and minor adverse     events that occurred during and after hospitalization until the end of the study   "
205093|NCT00526032|"     Primary Objectives:        -  To establish a statistically significant database: With Spectroscopic Oblique-Incidence          Reflectometry (OIR) experimental system, we will obtain OIR spatio-spectral images of          1,000 human skin non-melanocytic and melanocytic lesions that, based on clinical          diagnosis, are routinely biopsied and submitted for histopathologic diagnosis and of the          adjacent normal skin for self-referencing. The experimental database will contain          demographic information, clinical diagnoses, clinical images, OIR images,          histopathologic diagnoses, and morphometric data on the lesions.        -  To develop and validate a diagnostic algorithm:             1. Classification: A subset (~50%) of OIR images collected will be used to complete               the development of state-of-the-art image processing algorithms to extract robustly               effective diagnostic features.             2. Blind Testing and Evaluation: The algorithms established will be evaluated and               validated in a prospective blind-test fashion using the complementary subset of the               database that was not involved in designing the classifier. The sensitivity and               specificity of the classification system will be evaluated based on the               receiver-operating-characteristic (ROC) curve.        -  To identify the pathophysiologic parameters responsible for the diagnostic optical          features: The anatomic and physiologic sources of the diagnostic optical signatures will          be identified by comparative analyses using the OIR images, microscopic          histomorphometric techniques and theoretical modeling to test the following hypotheses:             1. The calculated differences in hemoglobin oxygen saturation.             2. Comparisons of the calculated size distributions of skin scattering centers with               histologic and morphometric analyses of various cellular and tissue components of               the skin lesions.             3. The relative densities and distributions of the different anatomic and physiologic               diagnostic features within the interrogation volumes are important diagnostic               factors in OIR.   "
205094|NCT00526045|"     This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in     patients with advanced solid malignancies to determine the maximum tolerated dose. Phase II     expansion arms will investigate efficacy in patients with either HER2 positive or ER positive     locally advanced or metastatic breast cancer. Additional patients with advanced solid     malignancies will also be investigated in a separate expansion arm. Safety, pharmacokinetics     and pharmacodynamics will be assessed.   "
205095|NCT00526058|"     The primary objective of the study is to demonstrate that the performance of the modified     Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved     Plasmat® Secura H.E.L.P Apheresis System for use under the approved indication of the acute     reduction of LDL-cholesterol from the plasma in populations for whom diet has been     ineffective and maximum drug therapy has either been ineffective or not tolerated.   "
205096|NCT00526071|"     This is a long term open label study of AT1001 in patients with Fabry disease previously     enrolled in a Phase 2 AT1001 trial.   "
205097|NCT00526084|"     Emerging results suggest that a cure rate of nearly 90 percent will be attained in the near     future. The advance was attributed to stringent application of prognostic factors for risk     factor-directed therapy. Early response to treatment has greater prognostic strength than     does any other biologic or clinical feature tested to dates. The measurement of minimal     residual disease(MRD) affords a level of sensitivity and specificity that cannot be attained     through traditional microscopic morphologic assessments. In Taiwan, detection for the most     recurrent fusion genes and the MRD were not commonly available, the TPOG(Taiwan Pediatric     Oncology Group) used clinical features, immunophenotypes, and cytogenetics to do risk group     classifications and protocol assignment. A successful rate of 60-70% has been reached. In     order to improve the cure rate of ALL in Taiwan, this project aims at establishing the     methods for better risk classifications and establishing MRD detection for risk-directed     therapy for childhood ALL in Taiwan.Intrinsic and acquired resistances to multiple anticancer     agents represent major obstacles and accounts for 10-20% of treatment failure in the     developed countries nowadays. Recent progress using DNA microarray identified differential     expression level of the genes known to implicate in cell cycle control, DNA repair and     apoptosis in different subsets of ALL patients, which were found to be related to drug     response. Genetic polymorphisms in the genes of drug-metabolizing enzymes, drug transporters     or drug targets, can influence the efficacy or toxicity of antileukemic agents. Specific     genotype might be important in determining the pharmacokinetic effects of one population or     disease subtype from that in others. Recently, the expression profiles of relatively few     microRNAs (miRNAs) (~200 genes), was noted to accurately classify human cancers. These     informations hinted that expression of the genes in the leukemic cells might serve as     additional risk factors for treatment stratification.      Specific aims and goals:        1. to establish better risk factors classification and use MRD to monitor early response to          treatment.        2. to establish the expression profiles of 12 genes associated with drug resistance        3. to unravel the pharmacogenetic background of pediatric ALL in Taiwan, so that will help          refine the therapy dose, achieve a better drug effect and avoid acute or chronic          toxicity.        4. microRNA expression profiles in childhood ALL in Taiwan   "
205098|NCT00526097|"     The objective of the study was to compare the efficacy and safety of 4 weeks treatment with     bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In     addition, the effect of treatment on quality of life and general health status was evaluated.   "
205099|NCT00526110|"     Phase I Objectives      Primary:      1. The primary objective of this study is to determine the maximum tolerated dose (MTD) of     Docetaxel combined with 5-Fluorouracil and Oxaliplatin (D-FOX) in patients with untreated,     locally unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction     (GEJ).      Secondary:      1. To determine the qualitative and quantitative toxicity and reversibility of toxicity of     this combination.      Phase II Objectives      Primary:      1. To assess time to cancer progression to D-FOX treatment regimen.      Secondary:        1. To assess response rate to D-FOX treatment regimen.        2. To determine the qualitative and quantitative toxicity and reversibility of toxicity of          this combination treatment regimen.        3. Determine overall survival.        4. Perform an exploratory investigation into the effect of D-FOX on phenotypic          abnormalities in blood.   "
205100|NCT00526123|"     The purpose of this clinical trial is to compare the longevity of two dialysis catheters.   "
205101|NCT00526136|"     To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg,     300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained     symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).   "
205102|NCT00526149|"     RATIONALE: BI 2536 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase II trial is studying the side effects and how well BI 2536 works in     treating patients with recurrent or metastatic solid tumors.   "
205103|NCT00526162|"     The purpose of the Consulta clinical study is to evaluate the overall system safety and     clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac     Resynchronization Therapy (CRT-D).   "
205104|NCT00526175|"     The purpose of this study is increase the efficacy of consolidation (C1) after an     intensification phase with high dose of methotrexate, applying analysis of minimal residual     disease   "
205105|NCT00526188|"     Participants who had been diagnosed or suspected by doctors to have focal liver lesions that     need further evaluation in order to make an accurate diagnosis. Participants would need to     have an enhanced magnetic resonance imaging (MRI) scan so that doctors could have further     information about the number and characteristics of the focal liver lesions.      Participants were invited to take part in this clinical study. The purpose of this study was     to evaluate Primovist, which is a liver-specific MRI contrast medium, on the efficacy of     lesion detection and characterization, and tolerability in Chinese patients with known or     suspected focal liver lesions.      Primovist, the investigational drug in this study, is a liver-specific MRI contrast medium     developed by Bayer Schering Pharma AG. Its active substance is Gd-EOB-DTPA. Primovist was     first approved in 2004 in Sweden followed by an approval in the European community, in     Switzerland and Australia in the same year.      Procedures:      Before entry into the study and after entry of the study a physical examination was     conducted, blood pressure and heart rate were measured, blood and urine samples were taken.     Current medications and medical conditions (including suspected pregnancy) and medical and     surgical history were elicited by doctors.      After entry into the study, participants were scheduled to have an MRI examination, which     lasted about 25-35 minutes.      During the MRI examination, an initial MRI scan without contrast was acquired which followed     by another MRI series after the intravenous administration of Primovist.      The following day participants were asked to return to the hospital for a follow-up safety     evaluation.      Possible Benefit Participants were scheduled to receive an enhanced magnetic resonance     imaging scan. Clinical studies indicated that Primovist increased the efficacy of detection     and characterization of focal liver lesions by providing better contrast between the focal     liver lesions and surrounding normal tissue. Primovist were shown to provide additional     information regarding existence, number and characterization (lesion or non-lesion, malignant     or benign) of these abnormalities.      Based on the experience with patients given Primovist, some adverse reactions were observed.      Most of undesirable effects were transient and of mild to moderate intensity. The most     commonly noted adverse events (AEs) in subjects receiving Primovist for MRI were nausea and     headache with an incidence of 1.1%. Other AEs that occurred in 0.5% of the subject population     were feeling hot (0.8%), back pain (0.6%) and dizziness (0.5%).      All other AEs occurred in less than 0.5% of the patients, e.g. anxiety; coughing; eye     disorder; fever; flatulence; generalized spasm; hypertension; injection site symptoms     including edema, inflammation, and reaction; lightheadedness; parosmia; postural hypotension;     taste perversion, motoric unrest; acute respiratory distress; fatigue; malaise; vomiting;     palpitations, erythema, chest pain and back pain.      Coldness, warmth or pain at the injection site, injection site reaction, and injection site     accumulation of fluid were rare. In very rare cases strong allergy-like reactions ranging to     shock may occur.      Post-marketing tachycardia and restlessness have been reported. As in the case of other     investigational drugs, there may also be unforeseen side effects.      Additional information concerning all Gadolinium- based contrast agents Primovist contains     the rare earth metal gadolinium as active ingredient. There have been reports of nephrogenic     systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents     (especially Omniscan) in patients with severe renal impairment. NSF is a systemic disease     characterised by formation of connective tissue in the skin, which becomes thickened and     hard, sometimes leading to contractures and joint immobility. The clinical course is usually     progressive and currently no treatment is available. To date NSF has only been reported in     association with some Gd-containing contrast agents, but the role of these contrast agents in     the overall pathogenesis of the disease is still not completely understood.      No reports of patients with NSF after administration of Primovist® are known. The risk to     trigger NSF in risk patients with severe renal impairment is considered to be low for     Primovist® due to the low dose given and the additional excretion via feces. Furthermore the     participation of patients with severe renal impairment are excluded from this study.      In case the participants were suffering from renal insufficiency, they were told to tell     their doctors prior to application of the contrast agent. In case the participants     experienced any new alterations of the skin following the administration of the contrast     agent, they were told to contact their doctors as soon as possible after they had recognized     these symptoms.   "
205106|NCT00526201|"     The purpose of this project is to determine if an evidence-based, community-delivered     physical activity program, EnhanceFitness, yields benefits for participants with arthritis.     The 3-year project will: 1) conduct a meta-analysis of community-based exercise programs for     adults, 2) implement and evaluate the EnhanceFitness program in West Virginia using a     randomized, controlled (wait list) design, and 3) disseminate the results to community and     public health partners. It is anticipated that participation in the EnhanceFitness program     will result in reduced pain, improved physical function and physical activity levels for     adults with arthritis.   "
205110|NCT00526266|"     The purpose of the study is to determine if a physiological marker, joint rotation of the     upper body, can be affected by the release of emotional trauma during a brief     psychotherapeutic encounter, and whether acupressure is an active ingredient in EFT.   "
205111|NCT00526279|"     To evaluate compliance and patients' satisfaction in mono and combination treatment of     Candesartan cilexetil (Atacand)/ Candesartan cilexetil 16mg, hydrochlorothiazide 12.5mg     (Atacand plus) in hypertension.   "
205112|NCT00526292|"     The goal of this study is to see if there is a benefit to giving chemotherapy and then     natural killer (NK) cells. The NK cells must come from a family member who shares half of the     patients HLA proteins. NK cells are a type of white blood cell. They can recognize and kill     abnormal cells in the body.      Patients whose blood cancer is not cured with a stem cell transplant do not have standard     treatment options. Studies have shown that NK cells from a donor can be given safely and can     be helpful in treating some blood diseases. These NK cells are collected from the patients     donor and purified using a separation system called CliniMACS that has been used safely in     previous studies and is used in this study with the approval of the Federal Food and Drug     Administration. The researchers want to find out what effects the NK cells will have on blood     cancer and bone marrow function and how to maximize its benefits in treating blood cancers.     The researchers hope that giving chemotherapy and then NK cells will be a better treatment     for the disease than the current available treatment options.      Funding Source - Food and Drug Administration/Office of Orphan Products Development   "
205113|NCT00526305|"     Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical     protocol with: intensification treatment of induction to increment the CR rate, allogenic     transplantation in first CR, autologous transplantation follow by alfa interferon in patients     cannot done allogenic transplantation.   "
205114|NCT00526318|"     RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of     tumor cells by stopping them from dividing or by killing them. It also prepares the patient's     bone marrow for the stem cell transplant. The stem cells are given to the patient to replace     the blood-forming cells that were destroyed by the chemotherapy. Giving isotretinoin after     transplant may kill any remaining tumor cells. It is not yet known which combination     chemotherapy regimen is more effective when given before a stem cell transplant and     isotretinoin in treating neuroblastoma.      PURPOSE: This randomized clinical trial is studying two different combination chemotherapy     regimens to compare how well they work when given before a stem cell transplant and     isotretinoin in treating young patients with high-risk neuroblastoma.   "
205115|NCT00526331|"     The purpose of this study is to determine whether the early identification and more precise     intervention of operating room (OR) patient fluid administration optimization using arterial     pressure-based cardiac output (APCO) yields comparable patient outcome as fluid     administration optimization using a global standard care method.   "
205116|NCT00526344|"     This study aims at determining the patterns of asthma remission, the prevalence of these     different patterns and the various factors associated with such remissions and possible     recurrences of asthma, in order to determine the mechanisms involved in these processes.      We therefore want to document these specificities in studying biopsies of subjects in     complete remission of their asthma and those in only symptomatic remission of their asthma,     in comparison with mildly symptomatic asthmatic subjects and healthy controls.   "
205117|NCT00526357|"     We wish to investigate the effects of 3 weeks of orally administered fish oil supplements on     the airway sensitivity (provoking dose to cause a 15% fall in FEV1, PD15) to inhaled mannitol     (AridolTM). Mannitol, an osmotic stimulus has been demonstrated as a useful model for     exercise-induced asthma. We also wish to investigate if there is any associated improvement     associated with selected markers of airway inflammation that can be measured in the sputum,     blood, urine and exhaled breath condensate. Oral fish oil supplements have recently been     demonstrated to be effective inhibitors of exercise-induced asthma, in association with an     inhibition of markers of inflammation, over a 3 week treatment period. This finding has     important implications in the treatment of asthma as this is a faster and more effective     improvement than what is seen with inhaled corticosteroids on exercise-induced asthma. This     observation requires validation and further investigation. We wish to study this in two     patient groups; (a) steroid naïve asthmatics taking beta2 agonist when required and (b)     asthmatics taking regular inhaled corticosteroids < 1000 mcg/day.   "
205118|NCT00526370|"     The purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare     with the cytological and histological diagnoses.      Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable     alternative to the routine cervical smear.   "
205119|NCT00526383|"     Since antidepressants and antipsychotics have common receptorial mechanisms of action (H1     antagonism, 5HT2 antagonism), the impact of antidepressants in terms of metabolic syndromes     is a matter of concern.      The main objective of this study is to assess the differential impact of antidepressants in     terms of weight gain and metabolic syndromes.   "
205120|NCT00526396|"     The purpose of this study is to compare the activity of fixed doses of cisplatin and     etoposide with toxicity adjusted dosing of the same drugs in the first-line treatment of     small cell lung cancer.   "
205121|NCT00526409|"     The study objective is to improve the global results obtained with LAL-AR-93 study, reaching     an event free survival between 60-70%.      Identify patients with bad prognosis, with minimal residual disease,who can benefit of     allogenic bone marrow transplantation   "
205122|NCT00526422|"     The purpose of this study was to determine what methods Dental PBRN dentists use for     diagnosis, prevention, and treatment of dental decay.   "
205123|NCT00526435|"     The overall goal of this study is to determine the whether the Walk with Ease (WWE) program     in its 2 version (group-assisted and self-directed) can increase physical activity and     fitness levels among individuals (18 years and older) with arthritis over the long-term.     Participants will be approximately 657 subjects from 20-24 rural and urban communities across     North Carolina. It is expected that participants in the WWE program will have reduced pain,     improved function and increased activity levels after participation in this 6-week program.   "
205152|NCT00527566|"     The purpose of this study is to determine whether Mepolizumab (a monoclonal antibody against     interleukin-5) is a safe and well-tolerated therapy that will allow for steroid tapering in     patients with steroid-dependent Churg-Strauss Syndrome (CSS).   "
205124|NCT00526448|"     To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C     virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C patients     genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD) 180 µg/week     and Ribavirin (2000 mg/day during 4 weeks, follow of 1000-1200 mg/day, according to body     weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200 mg/day,     according to body weight).      To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to     week 72, in SVR of these patients with genotypes 1-4 without rapid virological response (RVR     = RNA - HCV undetectable at 4 week).   "
205125|NCT00526461|"     RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells.     The drug becomes active when it is exposed to a certain kind of light. When the drug is     active, tumor cells are killed.      PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic     therapy using HPPH in treating patients with stage 0 non-small cell lung cancer.   "
205126|NCT00526474|"     The study is designed to determine whether vorapaxar, when added to the existing standard of     care (SOC) for preventing heart attack and stroke (eg, aspirin, clopidogrel) in participants     with a known history of atherosclerosis, will yield additional benefit over the existing     standard of care without vorapaxar in preventing heart attack and stroke.      The study is also designed to assess risk of bleeding with vorapaxar added to the standard of     care versus the standard of care alone.   "
205127|NCT00526487|"     The purpose of this study is to evaluate the safety and effectiveness performance of the     Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the     descending thoracic aorta.   "
205128|NCT00526500|"     The aim of this study is to determine effect of proprioceptive stimulation with passive gait     training on the cortical activity in patients with severe brain injury, demonstrated as     changes in EEG (electroencephalogram)and ERP (Event Related Potentials).      Hypotheses: 1) Proprioceptive stimulation increases EEG-frequency in patients with impaired     consciousness due to severe brain injury.      2) Proprioceptive stimulation increases conductivity speed of the cognitive P300-component of     ERP in patients with impaired consciousness due to severe brain injury.   "
205129|NCT00526513|"     Primary Objectives:      To determine the effect of insulin glulisine on glycemic control (HbA1c, FBG & PPBG) from     baseline to the end of the study.      Secondary Objectives:      To evaluate the safety of insulin glulisine in basal/bolus regimen by monitoring the     incidence of hypoglycemia and other adverse events.   "
205130|NCT00526539|"     Total hip replacement is a very cost effective procedure to enhance life quality in a group     of patients. In the period 2000-2004 7-8000 procedures were preformed, 13% were revisions     (1). Historically, many different principles have been used from the first resurfacings to     cemented and uncemented total hip replacements as we know them today. In 2000, 28 different     femoral stems and 26 different acetabular components were in regular use in Norway. There are     several well-documented cemented acetabular components, but no such uncemented cup. On the     femoral side there are several well-documented stems both cemented and uncemented. (2).      From the late 1990`s a reverse hybrid (uncemented stem and cemented cup) is being more     frequently used. In 2004 a total of 276 reverse hybrid hips were done and the trend is     increasing. (1). This technique is solely based on experience and the fact that one combines     the better of two principles (cemented and uncemented). There is no scientific evidence that     this technique is as good or better than a cemented THR.      One of the potential problems with hydroxyapatite coated components is that it is suspected     that it may increase wear due to the particle theory. (3,4). There are no prospective     randomised controlled RSA and DXA studies that conclude on this matter. This is such a study     and our hypothesis is that there is no difference in wear or osteolysis between the methods.   "
205131|NCT00526552|"     To evaluate the efficacy of rosuvastatin in Korean dyslipidemia patients with diabetes   "
205132|NCT00526565|"     This randomized clinical trial evaluates the efficacy of TAT(Tapas Acupressure Technique)     compared to a Social Support (SS) group for the primary outcome of weight loss maintenance.     We recruit obese adults from the Kaiser Permanente Northwest managed care setting. Those who     meet eligibility criteria are entered into an intensive six-month weekly group-based     behavioral weight loss program. Those who meet threshold weight loss criteria (n=~288) are     randomly assigned to either TAT instruction or social support group. Participants in both     groups attend the same schedule of group meetings with parallel contact hours. Participants     in the TAT group are advised to practice the technique at home. Participants are weighed and     questionnaires administered at entry, randomization, and at 12 and 18 months post entry. The     main outcome measure is weight at 18 months.   "
205133|NCT00526578|"     The goal of this research study is to investigate the role of genes that may point to a     higher risk of developing pancreatic cancer.   "
205134|NCT00526591|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving everolimus before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed.      PURPOSE: This randomized phase II trial is studying the side effects and how well everolimus     works in treating patients with newly diagnosed localized prostate cancer.   "
205135|NCT00526604|"     Low back pain is a usual conditions in the western countries and several treatments available     for patients with non-specific low back pain. According to the European guidelines are     exercise and cognitive intervention effective on pain and function(www.backpaineurope.org),     but it have no documented effect on return to work. In addition, there is no documentation     that treatments which focus on a single treatment, is effective with regard to return to work     for sick-listed patients.      The challenges for health personnel is not cure of the patients back pain, but to build up     rehabilitation programs which focus on disability and work incapacity, in patients which are     at risk of loosing their work. Dr. P. Loisel, Montreal, Canada, has since 1995 treated     patients with back pain according to the The PREVICAP model - (PREVention of work     handICAP), where the main purpose with work-related program is to prevent prolonged     disability and to help patients back to work. Loisel demonstrated that the PREVICAP models     accelerated the return to work factor by a factor 2.4 (p=0.01). The PREVICAP model have     also been evaluated in Amsterdam, by Dr. Anema with the same results.      At the Back Clinic, Ullevål University Hospital we have evaluated several exercise programs     with good effect on pain and function, but not on the return to work rate. We are planning to     do a randomized controlled trial after the PREVICAP model. All included patients in both     groups, will have an clinical examination by specialist in Physical Medicine and     Rehabilitation and an exercise program. Patients will be randomized to a work-related     rehabilitations program or to usual care by the general practitioner.      Hypothesis Main hypothesis: Sick-listed patients with back pain, who will be randomized to     the work-related rehabilitation programs, will return to work faster than patients randomized     to usual care by the general practitioner.      Second hypothesis: A cost-benefit analysis will favor the exercise program and work place     intervention   "
205720|NCT00535054|"     The purpose of this study is to determine safety and patients' satisfaction when using Tears     Again to treat Dry Eye Symptoms.   "
205136|NCT00526617|"     This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given     together with Temozolomide (chemotherapy) in treating patients with solid tumors, including     metastatic melanoma (MM), BRCA deficient breast, ovarian, primary peritoneal, or fallopian     tube cancer, and hepatocellular carcinoma (HCC).   "
205137|NCT00526630|"     The purpose of this research study is to examine whether Methylphenidate (MPD) can result in     improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main     disability is freezing of gait. MPD (Ritalin®) is a drug which can excite or stimulate     certain systems of the body that control motor function. This drug is FDA approved for the     treatment of attention hyperactivity disorder, a condition unrelated to PD.      The researchers hypothesize that daily treatment with a tolerable daily oral dose of MPD will     improve gait velocity, stride length, cadence, and decrease freezing of gait, 3 months from     treatment initiation in patients with moderately advanced PD, whose gait impairment is an     important source of disability despite optimized antiparkinsonian treatment.   "
205138|NCT00526643|"     The primary objective of this study is to evaluate the impact on overall survival (OS) of the     addition of cisplatin to gemcitabine vs gemcitabine alone in patients with advanced NSCLC in     poor clinical condition (PS 2), not previously treated.   "
205139|NCT00526656|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed.      PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in     treating patients with locally advanced bladder cancer.   "
205140|NCT00526669|"     The study will determine if changes in expression of markers involved in the 5-FU pathways     are associated with response to treatment with the combination of lapatinib and capecitabine     independent of tumor erbB2 status.   "
205141|NCT00526682|"     Hypothesis: Cissus quadrangularis as well as Irvingia gabonensis are used in weight     management and related conditions. This study set out to investigate if a combination of the     two could have additional benefits to overweight and obese people.   "
205142|NCT00526695|"     Sevoflurane preconditioning and cardiovascular protection against ischemia/reperfusion     injury.      Study hypothesis: The volatile anesthetic sevoflurane at subanesthetic concentrations     achieves endothelial protection against ischemia/reperfusion injury and reduces inflammatory     markers in the circulation   "
205143|NCT00526708|"     To evaluate the efficacy of rosuvastatin in Korean dyslipidemia patients with hypertension.   "
205144|NCT00526721|"     To evaluate achievement ratio of treatment target goal in hypercholesterolemia patients with     high risk after high dose rosuvastatin(20mg/day) titration   "
205145|NCT00526734|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, use different ways to stop cancer     cells from dividing so they stop growing or die. Stem cell transplant using stem cells from     the patient may be able to replace immune cells that were destroyed by chemotherapy used to     kill cancer cells. Giving colony-stimulating factors, such as G-CSF or pegfilgrastim, helps     stem cells move from the bone marrow to the blood so they can be collected. It is not yet     known which regimen is more effective in treating multiple myeloma.      PURPOSE: This randomized phase II trial is studying how well high-dose chemotherapy followed     by stem cell transplant works in treating patients with newly diagnosed stage I, stage II, or     stage III multiple myeloma.   "
205146|NCT00526747|"     Our goal of this pilot project is to identify inflammatory biomarkers that correlate with     epo-resistance among CKD patients.   "
205147|NCT00527501|"     The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed     combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN     dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension.   "
205148|NCT00527514|"     This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan     treatment regimen in stage 1 and stage 2 hypertensive subjects.   "
205149|NCT00527527|"     This randomized clinical trial pilot study will investigate the efficacy of different amounts     of total treatment dosage over six weeks in 60 volunteer subjects with lumbar spinal     stenosis. Subjects will be evenly randomized into four groups of either flexion distraction     (FD) care or a control: Group 1 with 8 total FD treatment visits, Group 2 with 12 total FD     treatment visits, Group 3 with 18 total FD treatment visits, or Group 4 with 8 total placebo     control visits. The study is designed: (1) To determine the feasibility of a larger scale     study in terms of logistics, recruitment efforts, and sample size estimations and (2) To     determine among the three treatment groups the change in perceived pain levels and general     functional health status at the end of six weeks of treatment and at three months post care     as follow-up.   "
205150|NCT00527540|"     Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated     Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current     this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a     (Pegaferon®) in the patients with chronic hepatitis C.   "
205151|NCT00527553|"     Age-related macula degeneration (AMD, encompassing both dry and wet form), the late stage of     Age-related maculopathy (ARM), is the leading cause of blindness in many developed countries     in older persons (usually over 60 years of age). Visual compromise rises exponentially after     the age of 70 with a 5-year incidence of around 1%. Studies have shown a possible protective     effect of lutein on progression of AMD, where visual acuity improves after increased lutein     intake. The incidence of bilateral AMD in persons with unilateral late ARM observed over a     period of 10 years is over 50% with a 2.1-2.8% overall incidence in the study population.      Blue light hazard (excitation peak 440 nm) was shown to have a major impact on photoreceptor     and RPE function inducing photochemical damage and cellular apoptosis, leading to retinal     degeneration in an animal study. The current belief is that lutein accumulated in the macular     region helps in the prevention of blindness by absorbing blue light and protecting the retina     from oxidative stress. With the lipid matrix of the egg yolk being a proven vehicle for the     efficient absorption of dietary lutein, it might be possible to increase plasma levels of     lutein to therapeutic levels and control or prevent AMD. This, the investigators hope, will     be accomplished by means of filtering out harmful blue light and the scavenging of free     radicals by lutein and zeaxanthin.   "
205153|NCT00527579|"     The purpose of this protocol is to measure peripheral benzodiazepine receptors in the brain     using positron emission tomography (PET) and compare the imaging results between patients and     healthy people.   "
205154|NCT00527592|"     The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in     the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.   "
205155|NCT00527605|"     This randomized, double-blind, placebo-controlled, six-month parallel-group study assess     efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic     Hyperplasia (BPH) , followed by a 12-month open-label treatment phase   "
205156|NCT00527618|"     To compare the effect of high-dose valacyclovir (1 gram orally twice daily) versus     standard-dose acyclovir (400 mg orally twice daily) on the frequency of genital HSV     reactivation and on plasma HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The     investigators hypothesize that high-dose valacyclovir will result in greater reduction in     plasma HIV-1 and genital HSV reactivation.   "
205157|NCT00527631|"     The prognosis for patients with advanced epithelial ovarian cancer remains poor despite     aggressive surgical resection and platinum-based chemotherapy. More than 60% of patients will     develop recurrent disease, principally intraperitoneal, and die within 5 years. The use of     whole abdominal irradiation (WAI) as consolidation therapy would appear to be a logical     strategy, but despite whole abdominal irradiation has clinically proven efficacy the use of     radiotherapy in ovarian cancer has profoundly decreased mainly due to high treatment-related     toxicity. Modern intensity-modulated radiation therapy (IMRT) could allow to spare kidneys,     liver, and bone marrow while still adequately covering the peritoneal cavity with a     homogenous dose.      This study will evaluate feasibility and toxicity of adjuvant consolidation whole abdominal     intensity modulated radiotherapy (IMRT) for high risk stage FIGO III patients with ovarian     cancer.   "
205158|NCT00527644|"     The Visu-Loc spring clip is being used to occlude the cystic duct at the time of laparoscopic     cholecystectomy. A HIDA scan will be completed on post operative day one to check for biliary     leaks.   "
205159|NCT00527657|"     The goal of this clinical research study is to find the highest safe dose of lomustine (CCNU,     CeeNUTM) that can be given with temozolomide (TemodarTM) and thalidomide (ThalomidTM) in the     treatment of metastatic melanoma that has spread to the brain. The safety and effectiveness     of this combination therapy will also be studied.   "
205160|NCT00527670|"     The aim of this study is to compare collagen composition in the skin and fascia of patients     with recurrent or incisional hernias versus normal controls. We will identify potential genes     responsible for genetic alterations in collagen deposition by using gene chip analysis of the     tissue obtained and comparing the hernia group versus controls. The ultimate goal of this     study is to identify target genes which may help us eventually predict which patients are at     risk for developing post-operative hernias.   "
205161|NCT00527683|"     The primary objective of this study is to assess the efficacy of vigabatrin for the treatment     of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine.     Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject     double- blind, randomized study is designed to show if with vigabatrin treatment but not     placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine     will become cocaine abstinent if they are self motivated to stop their cocaine habit. To     accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or     vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that     as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase     in the number of subjects who are abstinent for the final 3 weeks of the study.   "
205162|NCT00527696|"     To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal     obturator tape (TVT-O) procedures for the surgical management of female stress urinary     incontinence.   "
205163|NCT00527709|"     This pilot study is being pursued to observe whether certain medications are given to     patients within a timeframe where their being given could play a part in a critical event in     the management of the patient.      There are general rules about when it would be appropriate for these types of medications not     to be given. However, it is not current standard practice for the criteria to be put in place     without the expressed wishes of the ordering physician or their agent.      Research Question:      Can the administration of cardio-depressant medications be documented as a significant risk     factor for hypotensive or bradycardic events?   "
205164|NCT00527722|"     The purpose of this study is to demonstrate safety and effectiveness of the Bio-Seal Biopsy     Track Plug in a clinical setting for use in lung biopsy procedures to reduce the rate of air     leaks, commonly associated with the procedure. The Bio-Seal System is cleared in the U.S.     with an indication for use as a lung biopsy site marker.   "
205165|NCT00527735|"     The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin     has clinical benefit when compared with paclitaxel/carboplatin alone in patients with     previously untreated lung cancer.   "
205166|NCT00527748|"     Range of motion at ankle joint and subtalar joint will be assessed before and after     utilization of ARM device. The changes in range of motion will be recorded and compared to     literature.   "
205167|NCT00527761|"     Primary Objective:      1. To determine the maximum tolerated dose of chemotherapy using Taxotere, Temodar, Cisplatin     (TTC) in patients with metastatic melanoma.      Secondary Objectives:        1. To determine the toxicity of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in          patients with metastatic melanoma        2. To determine the response rate of induction chemotherapy using Taxotere, Temodar,          Cisplatin (TTC) in patients with metastatic melanoma.   "
205168|NCT00527774|"     The purpose of this study is to study whether hepatitis C virus (HCV)infected maintenance     hemodialysis (MHD)patients have distinct metabolic, inflammatory and adipokine     characteristics that can be linked to poor clinical outcome and to examine the hypothesis     that HCV infected MHD patients with metabolic syndrome have higher risks for hospitalization,     cardiovascular and all-cause mortality.   "
205169|NCT00527787|"     This study uses a randomized, double-blind, controlled design to demonstrate that PN400     (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal     ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric     ulcers compared to naproxen alone.   "
205170|NCT00527800|"     This is a prospective cohort study where HIV-infected and uninfected children will be     enrolled between 6 weeks and 9 months of age and followed to the age of 21 months. All     HIV-infected children will be given trimethoprim-sulfamethoxazole (TMP-SMX) prophylaxis as of     6 weeks of age. HIV-uninfected children born to HIV-infected mothers will be given TMP/SMX     prophylaxis for the duration of breastfeeding and then randomized to the continuation of     TMP/SMX or discontinuation of TMP/SMX prophylaxis. HIV-uninfected children born to     HIV-uninfected mothers will not be given TMP/SMX prophylaxis. Study participants will be     followed for all of their health care needs in a designated study clinic. All mother-child     pairs will receive a basic care package including insecticide-treated bednets (ITNs) at     enrollment. All HIV-infected mothers and children will receive antiretroviral therapy if     eligible according to standardized World Health Organization (WHO) criteria. Study     participants 4 months of age or older and at least 5 kg will be randomized to treatment with     artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DP) at the time of their     first diagnosis of uncomplicated malaria. Study participants will receive the same     antimalarial treatment regimen for all future episodes of uncomplicated malaria. Study     participants less than 4 months of age or less than 5 kg diagnosed with malaria and all     episodes of complicated malaria will be treated with quinine in accordance with local     guidelines.      The investigators will test the hypotheses that:        1. TMP/SMX prophylaxis is highly effective in preventing malaria in both HIV-infected and          HIV-uninfected children        2. The use of TMP/SMX prophylaxis is associated with an increased risk of infection with          malaria parasites containing antifolate resistance-conferring mutations.        3. The use of antiretroviral (ARV) drugs is associated with a decreased incidence of          malaria.        4. The efficacy, safety, and tolerability of AL and DP for the treatment of uncomplicated          malaria differ.           In 2008, we received approval and funding to extend the trial until 2012. We are now          following all children through 5 years of age. First randomization to continue or          discontinue TMP/SMX prophylaxis in our HIV-exposed population occurs 6-8 weeks after          cessation of breastfeeding when HIV status can be confirmed as negative by DNA PCR. A          second randomization occurs at 2 years of age in our HIV-exposed participants. At that          point all HIV-exposed children who were originally randomized to continue TMP/SMX          prophylaxis are again randomized to either immediately discontinue TMP/SMX prophylaxis          or continue prophylaxis until age 4 years. All children will be off TMP/SMX between 4          and 5 years of age.           We have also added an additional hypothesis to test during the study extension:        5. Prolonged TMP/SMX prophylaxis will result in an increased incidence of malaria in          children in the year immediately following cessation of prophylaxis compared to children          who have not used prophylaxis for over a year and those who have never been on          prophylaxis.   "
205171|NCT00527813|"     We project to test the effect of prone position on mortality in severe ARDS patients     (PaO2/FiO2<150 with FiO2 > or = 0.6 and positive end-expiratory pressure > or = 5 cmH2O).     Ventilator will be set in accordance with current standards aiming at protecting the lungs     from VALI. Patients will be randomized into two arms: prone group in which proning will be     realized for at least 16 hours a day and supine group in which patients will stay in a     semi-recumbent position. Primary end-point is 28-day mortality of all causes. Secondary     end-points are 90-day mortality of all causes and incidence of ventilator-acquired pneumonia.     Study sample was calculated to detect ability of proning to reduce mortality from 60 to 45%     percent, at one-tailed alpha error of 5% and power of 90% and 230 patients are needed in each     arm.   "
205172|NCT00527826|"     This is a 12 month randomized, open-label, parallel-group study to obtain data on the     frequency and variability of exacerbations in severe and very severe Chronic Obstructive     Pulmonary Disease (COPD) patients (Global Initiative for Chronic Obstructive Lung Disease     (GOLD) Stage III and IV) receiving salmeterol xinafoate and fluticasone propionate either in     fixed combination (SFC) or from separate inhalers (Sal/FP) with standard therapy. 200     subjects will be enrolled in approximately 30 study centres in Germany. Data on health care     utilisation will be collected to compare direct costs associated with COPD in these two     groups.      Baseline data will be collected for all subjects at Visit 1 and eligible subjects will be     randomized to receive either SFC 50/500 µg bid (twice daily) as fixed combination or Sal 50     µg bid (twice daily) and FP 500 µg bid (twice daily) concurrently over 52 weeks. Subjects     will return for study visits every two to three months until week 52. Additional telephone     calls will be made between scheduled visits every 4 weeks. Assessments will include     monitoring of frequency of exacerbations, health care utilisation (including emergency visits     and hospitalizations) and rescue medication, lung function, drug compliance, health-related     quality of life (SGRQ = St George's Respiratory Questionnaire) and safety.   "
205173|NCT00527839|"     Total joint replacements are some of the most successful medical devices developed over the     last fifty years. They enable millions of people to remain ambulatory and pain free, with     minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements,     and 25,000 total or partial shoulder replacements were performed in the United States (HCUP     data). Future use will likely be even higher: it is estimated that by the year 2020, the     population 65 and over in developed countries will increase by 71%. Existing studies do not     provide adequate prospective data to evaluate long-term outcomes.      HSS is a world leader in total joint replacement including total shoulder arthroplasty.     However, there is no systematic follow-up or evaluation of patients who have their shoulders     replaced here.      The purpose of this study is to establish a prospective cohort of HSS total shoulder     arthroplasty to evaluate predictors of outcome, causes of failure and to allow ongoing     evaluation of the results of our patients over time.   "
205174|NCT00527852|"     This is a study to to compare traditional fibre wound swabs to more recently developed     flocked swabs for the identification of Group A streptococcal pharyngitis in children     presenting to a children's emergency department.   "
205175|NCT00527865|"     This study will evaluate the safety, tolerability, and systemic exposure of an experimental     influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is     administered via oral inhalation using a special device. Study participants will include up     to 60 healthy, non-smoking males and females, ages 18-65. They will be given either DAS181 or     placebo. Participants will remain in the clinic overnight to be watched for health changes     for 24 hours after receiving the medication. Study procedures include: physical exams, chest     x-rays, ECGs, lung function tests, collection of blood and urine samples, and throat swabs.     Follow-up visits will occur on study days 2, 7, 14 +/- 1 day, and 30 +/- 2 days. Participants     will be involved in the study for up to 61 days, which includes the screening period.   "
205191|NCT00528073|"     This study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is     most effective in treating active moderate Crohn's disease. Rifaximin tablets are already     marketed in some European countries and the USA to treat traveller's diarrhoea. A new     gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will be     used in this study. These tablets dissolve in the stomach,releasing gastro-resistant granules     which pass into the intestines and deliver Rifaximin directly to the site of the disease.     Rifaximin is not absorbed, making it more effective and greatly reducing the frequency of     side effects.   "
205192|NCT00528086|"     To determine patient satisfaction with group visits versus standard of care delivery for     patients with Parkinson's disease.   "
205193|NCT00528099|"     To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending,     single subcutaneous or intravenous doses of IMA-026 in healthy Japanese male subjects   "
205211|NCT00528333|"     The purpose of this study is to assess whether there is a survival benefit with lintuzumab     given in combination with low dose cytarabine versus low dose cytarabine and placebo in     patients with AML.   "
205176|NCT00527878|"     This study will examine the safety and effectiveness of ranitidine (Zantac) in patients with     Hyper-IgE recurrent infection syndrome, a disease characterized by recurrent infections of     the ears, sinuses, lungs and skin, and abnormal levels of the antibody immunoglobulin E     (IgE).      Patients age 2 and older who have Hyper-IgE recurrent infection syndrome and who have had     chronic or frequent infections in the last 12 months may be eligible for this study.      Participants are randomly assigned to take ranitidine or placebo in pill or liquid form twice     a day for 12 months. In addition to treatment, patients undergo the following procedures     during visits scheduled on day 0 of the study (baseline) and at 3, 12, 15 and 24 months.     Evaluations at 6, 9, 18 and 21 months are by telephone.        -  Medical history and physical examination - baseline and 3 and 24 months.        -  Clinical severity score - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months.        -  Dermatology exam - baseline and 3, 12, 15 and 24 months.        -  Pulmonary function test - baseline and 12 and 24 months.        -  Chest CT - baseline and 12 and 24 months.        -  Quality of life assessment - baseline and 3, 12, 15 and 24 months.        -  Pregnancy testing - baseline and 3, 12, 15 and 24 months.        -  HIV test - baseline and 12 and 24 months.        -  Contraception evaluation - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months.        -  Missed school/work days assessment - baseline and 3, 12, 15 and 24 months.        -  Medication adherence - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months.      In addition to the above procedures, participants who are not enrolled in study 00-I-0159     have a baseline scoliosis series and genetic consult.   "
205177|NCT00527891|"     Primary Objective:      1. To compare the efficacy of 1.5T vs. 3T T1 and T2-weighted MR images sequences for the     detection and evaluation of liver lesions.   "
205178|NCT00527904|"     This study uses an open-label design and will be conducted in approximately 60 sites aiming     to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12     months exposure to PN400 (VIMOVO).   "
205179|NCT00527917|"     This is a pilot clinical investigation. Patients who meet the eligibility criteria and     provide signed informed consent will be randomized to receive either an active product     (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6     weeks of follow-up period.   "
205180|NCT00527930|"     Phase II trial of oxaliplatin in combination with S-1(SOX) in patients with recurrent or     metastatic breast cancer (MBC) previously treated with or resistant to an anthracycline and     taxane   "
205181|NCT00527943|"     The study is designed to determine whether vorapaxar, when added to the existing standard of     care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute     coronary syndrome, will yield additional benefit over the existing standard of care in     preventing heart attack and stroke.      The study is also designed to assess risk of bleeding with vorapaxar added to the standard of     care versus the standard of care alone.   "
205182|NCT00527956|"     To date, there is a paucity of research focusing on maternal breastfeeding goals, how these     goals may change after an unexpected event such as a preterm birth, and how mothers of ill     and preterm infants define breastfeeding success. No studies were identified that focused     exclusively on the breastfeeding goals of mothers of hospitalized preterm infants      The purpose of this study is to answer the following research questions: 1) What are the     breastfeeding goals of mothers with preterm infants in the NICU? and 2) What are mothers'     perceptions of facilitators and barriers to meeting their breastfeeding goals in the NICU?   "
205183|NCT00527969|"     The purpose of this study is to determine the efficacy and safety of REMEMBER-fX (HT1001, an     extract of Panax quinquefolius) in a human sample using standard clinical neuropsychological     instruments and side effects rating scales.   "
205184|NCT00527982|"     Primary Objectives:        1. To examine the effect of celecoxib treatment on histological response, markers of          proliferation (Ki-67), and apoptosis. Secondary endpoints include time to second primary          or recurrence and survival.        2. To examine the toxicity associated with celecoxib administration in patients with          previously treated Head and Neck Head and neck squamous cell carcinomas (HNSCC)or          Non-small-cell lung carcinoma (NSCLC).   "
205185|NCT00527995|"     This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg     sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects     on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular     autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.   "
205186|NCT00528008|"     The purpose of this study is to find out if chlorhexidine gluconate solution is better at     reducing the rate of wound infection after cesarean section compared to povidone-iodine.   "
205187|NCT00528021|"     The main purpose of this study is to investigate the safety and efficacy of an     investigational treatment for head lice infestation against a placebo.   "
205188|NCT00528034|"     Primary Objectives:        1. Determine the feasibility of using pretreatment lymphoscintigraphy to identify the          sentinel lymph node(s) in patients with vaginal cancer dispositioned to receive          radiation therapy.        2. Determine the feasibility of using preoperative lymphoscintigraphy and intraoperative          lymphatic mapping to identify the sentinel lymph node(s) in patients with vaginal cancer          dispositioned to undergo surgery and bilateral lymph node dissection.   "
205189|NCT00528047|"     The purpose of this study is to test the safety of PRLX 93936 and see what kind of effect it     has on patients and their cancer. This study will also determine the highest dose of PRLX     93936 that can be given without causing adverse side effects and the dose of PRLX 93936 that     should be used in future studies.   "
205190|NCT00528060|"     the trial assessed the pharmacokinetics and long term plasma exposure of the following     antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine     fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor     dosing history.   "
205194|NCT00528112|"     This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS).     The purpose of the study is to investigate which of the 2 administered doses is the lowest     effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for     contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5     years   "
205212|NCT00528346|"     The purpose of this study is to test a new investigational method for treatment of chronic     pain using cognitive training guided by functional magnetic resonance imaging (fMRI).   "
205195|NCT00528125|"     Pain prevention and/or therapy in neonates is still a challenge. It is widely accepted that     early pain experience can have a tremendous impact on the pain memory. We want to investigate     if a simple, fast method, that is nearly devoid of side effects can lead to a significant     alleviation of pain sensation in neonates. Acupuncture has been shown to be effective in     various painful conditions. Trials on acupuncture in children are rare. Trials on acupuncture     in neonates are lacking so far. Our hypothesis is that neonates in the active laser group     experience less pain than those in the placebo group.   "
205196|NCT00528138|"     It has recently been published that hyperbilirubinemia is a reliable marker for the     preoperative diagnosis of perforated acute appendicitis.      The investigators believe, based on their own previous publications, that C-reactive protein     (CRP) with or without a white blood cell count and some other clinical parameters, are more     specific markers for the preoperative diagnosis of perforated acute appendicitis.      The purpose of this study is to prospectively compare the specificity and sensitivity of     hyperbilirubinemia CRP, white blood cell count and other clinical parameters for the     preoperative diagnosis of acute appendicitis.   "
205197|NCT00528151|"     Background Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited ocular     disorder associated with a mutation in mtDNA . The common manifestation is visual loss which     caused by the respiratory chain enzymes complex dysfunction resulting in increased oxidative     stress enzymes production.      Purpose To determine whether curcumin which is an antioxidant agent is beneficial to the     patients with 11778 LHON mutation.      Material and Method Seventy patients with 11778 LHON mutation were randomly treated with oral     curcumin (500 mg/day) and placebo for 1 year. The visual acuity, computerized visual field,     electrophysiologic parameters and oxidative stress enzymes in plasma were compared before and     after treatment at 3, 6, and 12 months interval.   "
205198|NCT00528164|"     The purpose of this study is to determine whether an intense family-centered program to help     children, 4 to 7 years old, control their weight is more effective than the advise and     referrals their health provider gives in the primary care office.   "
205199|NCT00528177|"     The purpose of this study is to determine whether oxycodone provides better analgesia     compared to morphine after laparoscopic hysterectomy or myomectomy.   "
205200|NCT00528190|"     This clinical trial will attempt to determine whether we can improve clinical outcomes for     patients with cystic fibrosis who are infected with a fungus called Aspergillus fumigatus.   "
205201|NCT00528203|"     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease     that can cause intense pain episodes. The purpose of this study is to collect, test, and     archive blood and DNA samples from children and adults with SCD to study the role that genes     play in SCD. Blood and DNA samples will be stored for use in future SCD studies.   "
205202|NCT00528216|"     The purpose of this study is to evaluate potential changes in epidermal nerve fiber     immunostaining (ENFI) and sensory nerve function in healthy normal volunteers following     single applications of three different investigational topical Capsaicin Dermal Liquids (10%     w/v trans capsaicin), and a comparable control (propylene glycol). In addition, the pain and     tolerability of the application of each formulation will also be assessed. Data from this     clinical study may be used to select a formulation for further clinical evaluation.   "
205203|NCT00528229|"     The purpose of the study is to compare Multi-Slice Computer Tomography findings with     histological and physiological changes observed in transplanted lungs with Progressive Graft     Disfunction.   "
205204|NCT00528242|"     To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days     2101 dosing period.   "
205205|NCT00528255|"     This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal     insert when administered to nulliparous women at term gestation requiring cervical ripening     and induction of labor.   "
205206|NCT00528268|"     In this single-center trial, we will evaluate the effects of NaPB on presymptomatic Spinal     Muscular Atrophy (SMA) type I (cohort 1)and presymptomatic SMA type II (cohort 2) infants. A     variety of outcome measures will be performed at each study visit to follow the course of the     disease. Total duration of the study for type I infants will be 18 months, for type II     infants, 24 months.   "
205207|NCT00528281|"     This phase II study is a single-arm, two-stage, multicentre study to determine the clinical     activity of lapatinib in combination with pemetrexed in patients with Non-Small Cell Lung     Cancer (NSCLC) who have received one prior cytotoxic chemotherapy regimen. There will be a     short safety run in portion of the study to determine the optimal treatment regimen (OTR) for     the combination, since these two drugs have not previously been used together.      Approximately 27 patients will be enrolled into the first stage of the study and if     sufficient responses are seen an additional 27 patients will be enrolled into the second     stage giving an overall evaluable patient number of 54. Patients will be treated with     pemetrexed plus lapatinib at the determined OTR to disease progression, death or withdrawal     from the study treatment for any reason.      Safety and efficacy assessments will be performed on all patients at 6-week intervals, as     well as at the end of treatment. Patients withdrawn from study treatment with stable disease     will be assessed every 6 weeks until progression. Thereafter, patients will be followed for     survival at approximately 12-week intervals until death or to a maximum of 5 years after last     patient is enrolled, whichever comes first.   "
205208|NCT00528294|"     This trials examines the feasibility of GRID-therapy combined with biologically imaging based     IMRT (BG-IMRT). Within this trial, the strict toxicity parameters of primary treatment of     head and neck tumors are used. The GRID and BG-IMRT technique might be possible to reduce the     total radiation dose 2 to 3 times.   "
205209|NCT00528307|"     To determine whether Biventricular pacing in patients undergoing HIS bundle ablation for     atrial fibrilation has beneficial effects on myocardial perfusion and left ventricularr     ejection fraction.   "
205210|NCT00528320|"     This study provides a continued access registry for cardiac resynchronization therapy with     defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by     helping the left ventricle contract (pump blood) more uniformly, in patients with severe     heart failure (New York Heart Association [NYHA] Class III or IV).      Quality of life, adverse events and device success will be analyzed and reported.   "
206272|NCT00547989|"     Aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable     technique for extended, one sided, breast surgery.   "
205213|NCT00528359|"     The purpose of this study is to determine whether atypical antipsychotic drugs (commonly     prescribed for treating schizophrenia) induce changes in anthropometry and metabolism,     including alteration in insulin sensitivity and/or insulin secretion by the pancreas, when     given to lean, non-diabetic, individuals who are antipsychotic drug(s)-naïve, and free of     metabolic syndrome at enrollment.   "
205214|NCT00528372|"     The purpose of this clinical research study is to determine whether dapagliflozin can improve     (decrease) blood glucose values in patients with Type 2 diabetes who have never been treated     with medication or have been taking medication for less than 24 weeks since their original     diabetes diagnosis. The safety of this treatment will also be studied.   "
205215|NCT00528385|"     The main purpose of the study is find whether the addition of aldosterone antagonist,     spironolactone to dual renin-angiotensin-aldosterone system blockade involving angiotensin     converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction     of proteinuria, main prognostic marker of chronic kidney disease progression.   "
205216|NCT00528398|"     RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose     cytarabine works in treating patients with acute myeloid leukemia.   "
205217|NCT00528411|"     The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet     medication, affects platelets. Anti-platelet agents are medications that block the formation     of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding,     but when they form inside the arteries their formation is linked to a risk of medical     problems such as heart attack and stroke. This study investigated how long it takes for     Ticagrelor to begin working and how long it takes for it to stop working after the last dose     of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment     for preventing blood clots, and placebo plus Aspirin.   "
205218|NCT00528424|"     Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857     (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study     AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further     treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or     proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less,     the cord affecting that joint received less than three injections of AA4500, or they had     other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option     to receive up to five injections of AA4500 in this extension study. Subjects requiring     further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each     injection, with injections separated by four weeks. Follow-up visits for the determination of     efficacy and safety were conducted on Day 90, Month 6, and Month 9.      This study was designed to be part of the larger clinical program, for adult patients with     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal     Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7     non-pivotal studies were evaluated.   "
205219|NCT00528437|"     The purpose of this study is to:      Find out how safe and effective (by monitoring the good and/or bad effects) treatment with     high dose temozolomide, thiotepa and carboplatin with stem cell rescue followed by     13-cis-retinoic acid has on children and adolescents with recurrent/refractory brain tumors      Find out how the body uses 13-cis-retinoic acid by studying the your blood levels and     proteins in the blood that break down the 13-cis-retinoic acid      Determine how well 13-cis-retinoic acid penetrates into the spinal fluid.   "
205220|NCT00528450|"     RATIONALE: Tretinoin may help cancer cells become more like normal cells, and to grow and     spread more slowly. Drugs used in chemotherapy, such as arsenic trioxide and idarubicin, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving tretinoin together with arsenic trioxide with or without     idarubicin may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving tretinoin together with arsenic     trioxide with or without idarubicin works in treating patients with acute promyelocytic     leukemia.   "
205221|NCT00528463|"     Phantom limb pain is a complication of amputation. Although pre-empitve epidural analgesia     was once thought to prevent such a com plication, recent studies did not demonstrate this.     Peripheral blocks are more powerful then epidurals, and can even influence somatotropic     representation in the brain. This a prospective case series in which the investigators hope     to show a decrease, against historical control, of the incidence of post-operative amputation     lower limb phantom pain. The investigators established the block at least 24 hours     pre-operative and continue it for at least 2 days. Patient are followed daily for the 1st 3     days and then up to 3 month for the incidence of phantom limb pain. The investigators hope to     recruit 30 patients.   "
205222|NCT00528476|"     The purpose of this study is to determine clinical and urodynamic risk factors for recurrent     urinary tract infection in 5-18 years old children.   "
205223|NCT00528489|"     The purpose of this study is to determine the safety, tolerability, and immune response to     the DNA HIV vaccine, PENNVAX-B alone, in combination with IL-12, or with 2 different doses of     IL-15.   "
205224|NCT00528502|"     Primary Objective:      1. To determine if the application of lidocaine to the airway will obtund or abolish the     laryngeal reflexes. This in turn will lead to a quiescent controlled surgical field.   "
205225|NCT00528515|"     The purpose of this study is to prove if anesthesia maintained with the inhaled volatile     anesthetic desflurane is superior to the intravenously applied propofol anesthesia in     off-pump coronary artery bypass grafting (OP-CABG) surgery as measured by following     parameters:        1. hemodynamic parameters during and after the operation,        2. pulmonary gas exchange, need for mechanical ventilation and for ICU and intrahospital          stay,        3. release of heart muscle injury markers in response to surgery and intraoperative          ischaemia,        4. inflammatory response to the operation.      We suspect that insufflation anesthesia with desflurane may be superior to intravenous     anesthesia with propofol.   "
205414|NCT00540111|"     The purpose of this study was to assess the effect of soluble fiber® (partially hydrolyzed     guar gum) supplementation on hypertriglyceridemia and immune profile in HIV-positive     individuals on HAART.   "
205226|NCT00528528|"     The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics     (the study of the way a drug enters and leaves the blood and tissues over time), and     pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different     doses in combination with two standard therapies commercially available for chronic (lasting     a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.   "
205227|NCT00528541|"     The purpose of this study is to compare two types of botulinum toxin type A to treat the     involuntary muscle contractions in the neck   "
205228|NCT00528554|"     To investigate whether nonthermal low level laser acupuncture has beneficial effects on     nausea and vomiting in children receiving highly emetogenic chemotherapy for a malignant     solid tumor. In a previous crossover study comparing needle acupuncture to no intervention in     an otherwise similar setting we found beneficial effects, but this trial was not even     single-blinded and therefore the results are questionable. The hypothesis is that active     laser acupuncture is more effective than placebo laser acupuncture concerning episodes of     retching/vomiting (primary outcome measure) and rescue antiemetic medication (secondary     outcome measure) with a fix standard antiemetic medication   "
205229|NCT00528567|"     The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of     patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy     with 1 year of bevacizumab.      The secondary objectives of this trial are to:        -  compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free          Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to          treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination          with 1 year of bevacizumab        -  evaluate the safety and tolerability of bevacizumab      An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or     serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab     to standard adjuvant systemic treatment.   "
205230|NCT00528580|"     We propose a Phase II, randomized, placebo-controlled clinical trial to test the hypothesis     that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and     clinical outcomes in adults hospitalized with sepsis. As our animal models suggest     pretreatment with statins are required for their beneficial effects, we propose a study     design intended to identify patients and initiate treatment early in their hospital stay.     This Phase II study is intended to assess the feasibility of conducting a large-scale     investigator-initiated translational research protocol that involves multiple clinical     services within the Department of Medicine.   "
205231|NCT00528593|"     The purpose of this study is to evaluate the effect of epoetin alfa on HIV-associated     neuropathy by measuring changes in nerve fiber density and pain ratings.   "
205232|NCT00528606|"     This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the     United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal     (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at     least one finger, other than the thumb, that was at least 20° as measured by finger     goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or     placebo.      This study was designed to be part of the larger clinical program, for adult patients with     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal     Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7     non-pivotal studies were evaluated.   "
205233|NCT00528619|"     This study will assess the maximum tolerated dose, overall safety and antitumor activity of     SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and     carboplatin in patients with advanced solid tumors.   "
205234|NCT00528632|"     Cholesterolosis is a common finding in biopsy specimens of gallbladders surgically removed     for cholelithiasis.      To the best of the investigators knowledge no study has analyzed the relationships of Body     Mass Index, serum Cholesterol and Triglycerides and gallbladder cholesterolosis.      The purpose of this study is to analyze and find relations between gallbladder     cholesterolosis, Body Mass Index, serum cholesterol and triglycerides.   "
205235|NCT00528645|"     AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. This phase II study is studying how well giving AZD0530 works in treating patients     with extensive-stage small cell lung cancer.   "
205236|NCT00528658|"     Background: Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen     are commonly used oral analgesics in emergency departments (ED) not only in Hong Kong but     throughout the world. There are no large-scale (n>100), prospective, randomised studies     comparing paracetamol with ibuprofen in the management of acute soft tissue injury.      As paracetamol is cheaper than most NSAIDs, may be as effective in the management of acute     pain and possibly with fewer adverse effects, a large-scale, randomised, controlled trial is     needed to answer questions of relative analgesic efficacy, safety and cost-effectiveness.     Previous comparative studies on NSAIDS have been done in this unit and have suggested     equivalence between two NSAIDs and paracetamol, but numbers were small and drug doses were     modest.      Objective: To compare the efficacy, safety and cost between oral ibuprofen and paracetamol in     pain control for acute soft tissue injuries in an ED setting      Design: Prospective, double-blind, randomised controlled trial with three arms: oral     paracetamol with placebo; oral ibuprofen with placebo; paracetamol and ibuprofen in     combination      Participants: 783 subjects having sustained isolated soft tissue limb injury without     significant fracture presenting to the ED of Prince of Wales Hospital      Main outcome measures: Pain relief profiles of paracetamol, ibuprofen and the combination of     both; adverse effect profiles of paracetamol, ibuprofen and the combination of both; overall     cost effectiveness of paracetamol, ibuprofen and the combination of both from the perspective     of the healthcare provider   "
205237|NCT00528671|"     We aim to investiagte whether very low dose self management of oral anticoagulation is     superior to low dose oral anticoagulation in order to prevent bleeding events in patients     undergoing mechanuical heart valve replacement.   "
205282|NCT00529256|"     The Department of Family Practice at Michigan State University partnered with BCBSM with a     grant from the Robert Wood Johnson Foundation to recruit primary care practices for a 3 year     study designed to assess smoking cessation referral rates by primary care physicians in     Michigan.   "
207131|NCT00553085|"     The main objective of the study is to examine the relationship between anxiety disorders and     neurodevelopmental disorder/delay in children aged 7- 13 years.   "
205238|NCT00528684|"     RATIONALE: Oncolytic viruses such as reovirus (REOLYSIN®) can specifically kill tumor cells     while leaving healthy cells unharmed.      PURPOSE: This phase I/II study investigates the maximum tolerated dose (MTD), dose limiting     toxicity (DLT) and anti-tumor effect of intralesional administration of REOLYSIN® therapeutic     reovirus in patients with malignant glioma with evaluable disease which is     progressive/recurrent despite surgery and/or radiotherapy with or without chemotherapy. (The     phase I portion of the study is currently enrolling patients.)   "
205239|NCT00528697|"     The purpose of this study is to test if the investigational medication ABT-089 is a safe and     effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD.   "
205240|NCT00528710|"     Fundamentally, the trial aims to conduct a gold-standard test of the clinical impact of SAM-e     in the treatment of depressed mood and general symptoms of fibromyalgia (FMS).      As such, salient clinical and pathological parameters will be assessed over an 8-week period     in 60 patients who will be provided with either SAM-e or a placebo preparation . On the basis     of previous literature, it is hypothesised that patients in the active treatment group will     experience moderate but significant improvements across the clinical measures, and that these     gains will be significantly greater than any reported in the placebo group. All patients will     provide informed consent. All procedures will be conducted under medical supervision and the     preparation itself is very safe when used in the manner proposed for the trial   "
205241|NCT00528723|"     The purpose of this trial is to verify if the test treatment BDP 250 mcg/salbutamol 100 mcg     HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol 100 mcg pMDI fixed     combination given with the conventional CFC propellant (Clenil® Compositum 250, Chiesi     Farmaceutici) in terms of Pulmonary Function (morning PEF).   "
205242|NCT00528736|"     The aim of the study was to evaluate BNP in preterm infants < 28 weeks on the second day of     life, when it is still unknown, if a patent ductus arteriosus is hemodynamic significant or     not. We hypothesized that high plasma BNP concentrations on day 2 are associated with the     need of PDA intervention in the further course.   "
205243|NCT00528749|"     This study is intended to compare intrathoracic pressure and respiratory effort data obtained     by forehead venous pressure and respiratory movement (FVP/RM) with data obtained by the     current gold standard, esophageal manometry. If this feasibility study validates the ability     of FVP/RM data to quantitatively measure respiratory effort non-invasively, further studies     will be performed to validate the utility of the ARES device in diagnosis of the UARS.   "
205244|NCT00528762|"     Primary Objective:      For focus groups of Mexican American and African-American girls and focus groups of their     parents to explore factors that could enhance the conduct of a future study of puberty and     body mass.      Specifically these focus groups will address:        -  Whether clinical assessment of pubertal staging is acceptable.        -  How to enhance cooperation by parents and their daughters of different socioeconomic          groups, among families with different levels of acculturation, and girls of different          body mass indices.        -  Explore whether established questionnaire items about puberty, that have been used in          traditional surveys, require culture-specific changes to improve exposure assessment.        -  Explore the acceptability of self-reported pictograms for body image and for          developmental assessment by girls.   "
205245|NCT00528775|"     RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is     exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may     be an effective treatment for advanced non-small cell lung cancer that blocks the air     passages.      PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in     treating patients with advanced non-small cell lung cancer that blocks the air passages.   "
205246|NCT00528788|"     Patients with chronic kidney disease and end stage renal disease have greater cardiovascular     risk than the general population. Vitamin D analogues have been shown in observational     studies to have mortality benefit for these patients. This study is designed to investigate     doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible     mechanism to explain the mortality benefit.   "
205247|NCT00528801|"     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease     that can cause intense pain episodes and may lead to organ failure. Preliminary studies have     shown that adults with SCD may have brain abnormalities that contribute to problems with     cognitive functioning, including attention and memory difficulties. This study will use brain     magnetic resonance imaging (MRI) and neuropsychological testing to examine the differences in     cognitive functioning in adults with SCD and adults without SCD.      212 subjects participated in this cross-sectional study consisting of screening     questionnaires, a neuropsychological testing battery, and MRI testing. Enrollment into this     study ended in May 2008.   "
205248|NCT00528814|"     Asthma is a common, serious illness among children in the United States. Improving hand     cleanliness and hygiene may prevent the spread of viruses that can cause asthma     exacerbations. This study will evaluate the effectiveness of a school-based hand sanitizer     program at reducing the frequency of exacerbations in children with asthma.   "
205249|NCT00528827|"     To define the relationship between Cardene I.V. dose, serum concentrations, and blood     pressure reduction in pediatric subjects with hypertension.   "
205250|NCT00528840|"     This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a     diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal     interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one     finger, other than the thumb, that was at least 20° as measured by finger goniometry and was     suitable for evaluation and injection were enrolled.      This study was designed to be part of the larger clinical program, for adult patients with     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal     Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7     non-pivotal studies were evaluated.   "
205283|NCT00529269|"     This study will evaluate the impact that GI complaints have on patient-reported outcomes and     to determine if there is improvement in patient-reported outcomes when converted from     mycophenolate mofetil (MMF) to Enteric-coated mycophenolate sodium (EC-MPS)   "
205284|NCT00529282|"     The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a     comparator in patients with fever and neutropenia   "
205251|NCT00528853|"     A major source of graft failure and dysfunction in lung transplantation is known to be     bronchiolitis obliterans (BO)and its clinical correlate called bronchiolitis obliterans     syndrome(BOS). In fact, BOS is the leading cause of death in lung recipients beyond one year     post transplant. Currently, our ability to assess lung injury after transplant is less than     ideal.      The purpose of this study is to use new computerized tomography(CT) technology, specifically     , 64 bit acquisition, to detect and predict the onset of lung injuries, with the hope of     finding better therapies that currently exist.   "
205252|NCT00528866|"     RATIONALE: Specialized radiation therapy that delivers a high-dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can     cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide,     goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body.     Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation     therapy together with androgen suppression and docetaxel after surgery may kill any tumor     cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving radiation therapy together with     androgen suppression and docetaxel works in treating patients with high risk prostate cancer     who have undergone radical prostatectomy.   "
205253|NCT00528879|"     The purpose of this clinical research study is to learn whether dapagliflozin can help reduce     blood sugar levels in participants with Type 2 diabetes that is not well controlled on     metformin alone. The safety of this treatment will also be studied.   "
205254|NCT00528892|"     The investigators hypothesis is that switching from a ritonavir-boosted PI to raltegravir may     be associated with an at least non-inferior effectiveness, virological response and safety,     and even a better tolerability profile with regard to lipid metabolism, insulin resistance,     body fat distribution as compared with continuation of the baseline regimen in HIV-1     seropositive males or females at least 18 years of age and older on ritonavir-boosted PI plus     at least 2 other drugs and plasma viral RNA below 50 copies/mL.   "
205255|NCT00528905|"     The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with     stable schizophrenia who are being treated with an atypical antipsychotic and who are active     cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal     dose(s) to be used in future trials.   "
205256|NCT00528918|"     The purpose of this study is to compare Apidra (a rapid acting insulin analogue) with Regular     insulin (fast acting) in addition to the use of long acting insulin Glargine in hospitalized     patients in terms of efficacy and safety in blood glucose control and frequency of low blood     glucose. Blood glucose control along with incidence and rate of low blood glucose during the     hospitalization shall be of primary interest; length of hospital stay comparing the short     acting insulin used shall be the secondary interest.   "
205257|NCT00528931|"     A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's     contracture conducted at one site in the United States. All subjects received a single dose     of AA4500 0.58 mg, which was injected directly into the cord affecting either the     metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood     samples were collected before dosing, at predetermined time points through the 24 hours after     dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after     the AA4500 0.58 injection.      This study was designed to be part of the larger clinical program, for adult patients with     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal     Placebo-Controlled studies (AUX-CC-857 [NCT00528606]and AUX-CC-859 [NCT00533273]) and 7     non-pivotal studies were evaluated.   "
205258|NCT00528944|"     Although single breath helium (He) dilution measurement (VASB) is currently used in pulmonary     function laboratories to assess functional alveolar volume and diffusing capacity for carbon     monoxide, the extent to which VASB reflects ventilatory and thoracic volume has not been     prospectively determined in emphysema. We hypothesized that VASB underestimates rebreathe     helium dilution volume (VARB), and plethysmographic volume (VApleth) as clinical and     physiologic severity of emphysema increases.   "
205259|NCT00528957|"     The purpose of this study is to assess the safety and efficacy of switching to tenofovir     disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining     virologic suppression in HIV-1 infected children.   "
205260|NCT00528970|"     To assess, in subjects who have ventral wall hernia repair, the time between the end of     surgery and first bowel movement with the investigational MOA-728 regimen as compared with a     placebo regimen.   "
205261|NCT00528983|"     The purpose of this study is to determine whether a tablet form of azacitidine that taken by     mouth is safe. This Phase I study will also look at different doses and different treatment     schedules in order to better understand the effects (positive and negative) of oral     azacitidine on the body and on the disease MDS, AML and CMML.   "
205262|NCT00528996|"     The primary objective of this study is to compare the bronchodilator efficacy of three doses     (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and     tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives     include comparing the effects on dyspnea and health status.   "
205263|NCT00529009|"     To assess the bile acid composition of cystic bile and serum pharmaco¬kinetics after a 3-week     treatment with UDCA and to correlate pharmacokinetic parameters of UDCA in bile and serum     during steady state.   "
205264|NCT00529022|"     The goal of this clinical research study is to find out if giving azacitidine with valproic     acid plus carboplatin can help control advanced cancer. The safety of this treatment will be     studied as well. Researchers will also collect some extra blood samples for molecular marker     studies (studies that may help researchers predict how participants respond to the combined     therapy).      There were to be two phases of this study: a Phase 1 portion to find acceptable doses of the     study drug combination, and a Phase 2 portion to study the response rates to the treatment     schedule. The study did not proceed to the Phase 2 portion.   "
205285|NCT00529295|"     The purpose of this study was to estimate the safety and efficacy of titrated oral     misoprostol compared with vaginal route for labor induction at term.   "
205821|NCT00542113|"     The purpose of this study was to evaluate the effectiveness of a school-to-home education     program for it's ability to increase knowledge about, and ability to prevent type two     diabetes in children and parents.   "
205265|NCT00529035|"     The purpose of this research study is to determine the safety of IL-2 and the highest dose of     this drug that can be given safely to people with chronic graft versus host disease (GVHD).     Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem     cell or cord blood transplant. The donor's immune system may recognize their body (the host)     as foreign and attempt to reject it. Traditional standard therapy to treat chronic GVHD is     prednisone (steroids). Treatment options are limited, and it is thought that IL-2 may help to     control chronic GVHD.   "
205266|NCT00529048|"     Patients with T2DM lac a sufficient incretin response after oral glucose intake. It has only     been tested using 50g of glucose. We don't know if patients with T2DM are capable of     regulating the incretin effect like healthy people in responds to different amounts of     glucose intake.      The aim of the present study is to quantify the incretin effect in healthy subjects and in     patients with T2DM during increasing amounts of oral glucose challenges. The proposed studies     will answer important questions on the mechanisms underlying T2DM and be of importance in     relation to future preventive- and treatment strategies.   "
205267|NCT00529061|"     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease     that can cause intense pain episodes. The purpose of this study is to gather medical     information from children and adults with SCD and establish a database so that researchers     can contact people to participate in future SCD research studies.   "
205268|NCT00529074|"     We plan to demonstrate the superiority of epidural anaesthesia/analgesia in repairs of large     ventral hernias as compared with a conventional narcotic analgesia regimen.      We hypothesize that:        1. Primary outcome measures will improve. Patients will have a shorter length of stay (1          day less) with pre and post-operative epidural analgesia.        2. Secondary outcome measures will also improve. Among them will be VAS pain scores, time          to first flatus and bowel movement as well as major and minor complications.   "
205269|NCT00529087|"     The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of     subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have     Opioid-Induced Constipation (OIC).   "
205270|NCT00529100|"     Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being     treated with pemetrexed in combination with cisplatin and radiation.   "
205271|NCT00529113|"     This study assesses the safety and efficacy of RTA 402 in combination with gemcitabine in     patients with unresectable pancreatic cancer.   "
205272|NCT00529126|"     Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine     HCl.   "
205273|NCT00529139|"     Mortality rates of patients with acute kidney injury in the intensive care unit have changed     little over the past few decades despite significant advances in supportive care. Few     interventions have been shown to result in an improvement of in-hospital mortality of these     patients, with dose of renal replacement therapy (RRT) being one of the most important.     Patients undergoing continuous veno-venous hemofiltration had better outcomes with     ultrafiltration rates of 35 mL/kg/h or 45 mL/kg/h than those treated at a rate of 20 mL/kg/h.     In a different trial, intermittent hemodialysis on a daily basis resulted in better control     of uremia, fewer hypotensive episodes during dialysis, and more rapid resolution of acute     renal failure than thrice weekly hemodialysis. In the present study we examine survival and     renal recovery in critically ill patients with acute kidney injury that are treated with a     currently recommended (standard) dose of RRT, and patients that receive intensified RRT.   "
205274|NCT00529152|"     -  The primary objective is to assess the safety of Ferriprox oral solution for the          treatment of iron overload in pediatric patients with transfusion-dependent anemia.        -  The secondary objective is to assess the efficacy of Ferriprox oral solution in reducing          iron overload in pediatric patients with transfusion-dependent anemia.   "
205275|NCT00529165|"     The purpose of the study is to demonstrate, that there is no difference in metabolic control     in patients with type 2 diabetes mellitus and therapy with human insulin with or without     injection-meal-interval.   "
205276|NCT00529178|"     To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease,     the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to     placebo.   "
205277|NCT00529191|"     The goal of this application is to evaluate the safety and efficacy of atorvastatin as a     potential treatment to preserve beta cell function in children and young adults with newly     diagnosed type 1 diabetes (T1DM).   "
205278|NCT00529204|"     Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are common     complications of type 2 diabetes and leading causes of liver disease in the US and Europe.     The prevalence of NAFLD and NASH are expected to become a major cause of liver disease     related deaths and liver transplantation. Currently, there are no specific therapies that     alter the natural history of NAFLD.Preliminary evidence suggests that exenatide (Byetta®) may     have several beneficial direct and indirect effects on NAFLD and liver lipid metabolism.   "
205279|NCT00529217|"     The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic     stimulation in the treatment of Depersonalization Disorder (DPD).   "
205280|NCT00529230|"     Primary Objective:      1. To determine the prevalence of secondary hypogonadism in male patients on chronic opioid     therapy for cancer-related pain syndromes.      Secondary Objective:      1. To determine the degree of sexual dysfunction, fatigue, and depression prevalent in male     patients on chronic opioid therapy for cancer-related pain syndromes.   "
205281|NCT00529243|"     The primary objective of this study is:      To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human     immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of     serum human immunodeficiency virus(HIV) (< 75 copies/ml by branch deoxyribonucleic acid     (bDNA) assay, < 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their     current HIV medication regimen.      Hypothesis:      HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA     levels below limits of quantification can safely have the investigational integrase     inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.   "
205445|NCT00540514|"     The purpose of this study is to compare disease response of Albumin-bound paclitaxel     (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients     with advanced non-small cell lung cancer (NSCLC).   "
205286|NCT00529308|"     This study will evaluate the clinical efficacy of 1 Hz repetitive transcranial magnetic     stimulation (rTMS) applied to the supplementary motor area (SMA) in Tourette's Syndrome (TS)     patients who have not fully responded to conventional therapies. The investigators will     collect TMS measures of motor cortex excitability to test whether rTMS restores normal levels     of intracortical inhibition found to be deficient in TS. The investigators will administer     neuropsychological tests to demonstrate that SMA targeted rTMS can be administered safely     without significant impairments of cognitive or motor functioning. The investigators     hypothesize that:        1. Compared to sham (placebo), active rTMS will improve symptoms of TS as assessed with the          Yale Global Tic Severity Scale (Y-GTSS) and Clinical Global Impression (CGI).        2. Active (but not sham) rTMS will normalize levels of motor cortex excitability, as          reflected by increased intracortical inhibition, motor threshold, and cortical silent          period, and by decreased intracortical facilitation, relative to pre-treatment baseline.   "
205287|NCT00529321|"     The primary objective is to determine the safety of sub-cutaneous (SC) injections of TG4040     in non-cirrhotic, treatment-naïve patients chronically infected with HCV (genotype 1).      Patients will be sequentially treated at an escalting dose of TG4040. All patients will be     followed up to at least 6 months after his/her first injection. In addition, all patients     treated at the highest dose will receive a TG4040 boost injection 6 months after the first     injection, and will be followed up during an additional 6-month period.   "
205288|NCT00529334|"     This pilot study will evaluate the technical feasibility and acute toxicity of Partial Breast     Irradiation (PBI) with the CyberKnife in anticipation of a larger multi-institutional Phase     II study. It will evaluate quality of life (QOL) issues as they relate to treatment related     side effects, cosmetic result, and patient convenience.      Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or     less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this     protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and     sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK).     Subjects will receive CK before chemotherapy, if applicable.   "
205289|NCT00529347|"     Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA     delivers assist to spontaneous breathing based on the detection of the electrical activity of     the diaphragm. We study the effect of changing ventilatory parameters on the patient's     breathing pattern during NAVA.   "
205290|NCT00529360|"     Hypothesis: Myeloablative conditioning using a dose escalation of clofarabine in combination     with cytarabine (ARA-C) and total body irradiation (TBI) will lead to improved survival for     previously untransplanted children and adolescents with acute lymphoblastic leukemia (ALL)     and acute non-lymphoblastic leukemia (ANLL)followed by allogeneic stem cell transplantation     (AlloSCT).   "
205291|NCT00529373|"     The purpose of the event-driven base study is to determine the safety and efficacy,     especially fracture-risk reduction, of odanacatib in postmenopausal women diagnosed with     osteoporosis. In a placebo-controlled extension of the base study, participants continue to     receive the same blinded study medication for a total of up to 5 years of blinded study     medication combined between the base study and the extension. After all participants receive     at least 5 years of blinded study medication, they will be invited to enroll into a second     extension study in which they will receive open-label odanacatib for an additional 5 years.   "
205292|NCT00529386|"     The objective of this study is to evaluate the safety and efficacy of intraprostatic     injection of Botox for the treatment of men diagnosed with chronic nonbacterial     prostatitis/chronic pelvic pain syndrome (CP/CPPS).   "
205293|NCT00529399|"     The purpose of this study is to determine whether treatment with multiple injections of     GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have     been recently diagnosed with type 1 diabetes mellitus (T1DM).   "
205294|NCT00529412|"     To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in     patients who underwent surgery for gastric cancer.   "
205295|NCT00529425|"     Reducing pain is an essential factor for early mobilization after osteosynthesis of femoral     neck fractures. Systemic opioids have side effects that might obstruct mobilization and     induce delirium and nausea. The investigators hypothesized that wound infiltration results in     reduction in systemic opioid usage and pain relief without side effects.   "
205296|NCT00529438|"     This study assesses the tolerability, safety, efficacy and pharmacokinetics of Bardoxolone     methyl (RTA 402) in advanced solid tumors and lymphoid malignancies.   "
205297|NCT00529451|"     This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300     mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.   "
205298|NCT00529464|"     Primary objectives        1. To conduct a randomized clinical trial of the emerging technology fluorescence and          reflectance spectroscopy, comparing colposcopy to colposcopy + spectroscopy in the          diagnostic setting, stratifying patients by outside Papanicolaou (Pap) smear of low          grade and high grade squamous intraepithelial lesions, and to use multispectral digital          colposcopy retrospectively.           The number of clinically read referral Paps, clinically read UT MD Anderson Cancer          Center (MDACC) Paps, quantitatively read Paps, quantitatively read biopsies, point probe          fluorescence/reflectance spectroscopy, and the multi-spectral digital colposcopy image,          that shows a possible cancer, High-grade Squamous Intraepithelial Lesion (HGSIL),          Low-grade Squamous Intraepithelial Lesion (LGSIL), or changes less than LGSIL to          colposcopically directed biopsies at the first visit, Loop Electrical Excision Procedure          (LEEP) at the second visit if needed, repeat evaluations at 6, 12, and 18 months that          have Paps, or Paps + Endocervical Curettage or sample of the cervical canal + possible          biopsy, and at the 24 month visit when all patients will at minimum have a Pap and an          Endocervical Curettage for certain, and a cervical biopsy if any colposcopic abnormality          is present.        2. To see if optical spectroscopy using both the point probe and the multi-spectral device          improves diagnosis by improving specificity over colposcopy alone.             1. To study the number of colposcopically directed biopsies that show High-grade               Squamous Intraepithelial or cancer.             2. To study the number of LEEP specimens that show HGSIL or cancer.   "
207851|NCT00562770|"     To determine if the rate of cytomegalovirus reactivation during treatment with alemtuzumab     (Campath) is reduced by the use of valganciclovir prophylaxis.   "
205299|NCT00529477|"     The objective of this study is to examine the functional effects of methacholine challenge on     small airways using three different nebulizers to generate particles with HMAD suitable for     distribution in small, intermediate and large airways.Pulmonary function will be assessed     using plethysmography and impulse oscillation techniques. Eight asthmatic subjects (>18     years, both sexes) who are stable clinically and require only intermittent ß2-agonist     treatment will be recruited to undergo methacholine challenges for an in vivo, dose-finding     observational study. Three separate methacholine challenges will be carried out using each of     the three different nebulizers. After each challenge, pulmonary function tests will be     performed on subjects to assess functional changes in large and small airways. Results of the     tests will be compared between the three nebulizers. These experiments will demonstrate     whether or not functional changes occur in small airways in response to methacholine, as     measured by pulmonary function tests after selectively targeting small airways using the     nebulizer which generates small particles. The results from these experiments will give us a     better understanding of the role of small airways in methacholine-induced bronchoconstriction     in asthmatics, and will compare sensitivity of plethysmography compared to forced oscillation     for detecting changes in small airways.   "
205300|NCT00529490|"     Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic     lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic     stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible     received either hypertonic lactate solution or Ringer's Lactate post-CABG in the ICU when     fluid resuscitation was needed.   "
205301|NCT00529503|"     This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus     placebo in patients with DLBCL. The study will assess safety and tolerability and will     measure any additional clinical benefit observed in patients receiving SGN-40.   "
205302|NCT00529516|"     Since influenza vaccines are administered every year because of the frequent change in their     antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza     vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this     observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will     receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only     subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for     participation in this study.   "
205303|NCT00529529|"     This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg     capsules) once daily [od]), compared with salmeterol (50 μg twice a day [b.i.d.]), over 26     weeks, in patients with moderate to severe persistent asthma.   "
205304|NCT00529542|"     The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the     treatment of PCOS with elevated LDL cholesterol.   "
205305|NCT00529555|"     Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of     the root surfaces of the teeth. This is also called scaling and root planing. Placing a     topical antibiotic into the periodontal pocket at the time of scaling and root planing may     help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl)     2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now     being tested in the US.   "
205306|NCT00529568|"     The purpose of this study is to assess the ability of eltrombopag to maintain a platelet     count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy     dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical     benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve     a Sustained Virological Response (SVR).   "
205307|NCT00529581|"     The purpose of this study is to determine the safety and efficacy of C105 in treating the     cognitive deficits that can occur due to multiple sclerosis.   "
205308|NCT00529594|"     The study wants to show if the medication etoricoxib 120 mg have reduces the patients pain     during the laser photocoagulation, for diabetic retinopathy.   "
205309|NCT00529607|"     The primary purpose of this study is to correlate new cardiac imaging modalities (2D, 3D     echocardiography, contrast echocardiography, strain analysis and cardiac MRI) to biochemical     parameters as the L-arginine-nitric oxide pathway and inflammatory cascades to characterize     the reperfusion injury following myocardial infarction and thus providing a basis for further     diagnostic and therapeutic approaches.   "
205310|NCT00529620|"     The purpose of this trial is to compare the acceptability, efficacy and safety of three     alternative drug regimens for use for seasonal Intermittent Preventive Treatment to prevent     malaria in children. Children aged 2 months to 5 years will be randomized to receive IPT with     one of three regimens during the transmission season: sulfadoxine-pyrimethamine (SP) plus     amodiaquine, show to be highly effective for IPT in a recent trial; SP plus piperaquine, used     for malaria prophylaxis in China for many years; or Duocotexcin (a combination of piperaquine     with an artemisinin).   "
205311|NCT00529633|"     Both malnutrition and inflammation are associated with death in dialysis patients and also     with cardiovascular disease. The researchers are testing the idea that inflammation causes     malnutrition by using a drug to suppress inflammation in hemodialysis patients to find out     whether that will increase blood tests that are associated with malnutrition. The researchers     will give hemodialysis patients who have both inflammation and malnutrition either     thalidomide or a placebo and compare the effects of treatment on the levels of two proteins     in the blood, albumin and prealbumin, that are normally reduced in malnourished patients.     Patients who have a serum albumin concentration < 3.8 g/dl will be asked to sign consent to     have blood drawn prior to dialysis for measurement of CRP (C-reactive protein). Those with     CRP values ≥ 0.8 mg/dl will have a second measurement of CRP performed within 2 weeks. Those     with two consecutive values of CRP ≥ 0.8 mg/dl will be eligible for enrollment   "
205312|NCT00529646|"     The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791     when administered as a single oral dose to healthy adult subjects.   "
205313|NCT00529659|"     A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with     sarcopenia (loss of muscle mass).   "
205415|NCT00540124|"     The primary purpose of this clinical trial is to evaluate the change in the International     Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the     study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day     dosing for 12 weeks of treatment.   "
205314|NCT00529672|"     For more than 100 years, surgery has been the standard of care of varicose veins of the legs.     The down side of surgery is that it requires anesthesia, leaves scars, and has a relatively     high recurrence rate in the long term (up to 40%). In the last decade, several new techniques     have become available but they have not yet been compared to surgery. This trail will     evaluate the effectiveness, patients` perspective and cost effectiveness of surgery and     non-invasive techniques such as ultrasound guided sclerotherapy with foam and endovenous     laser therapy.   "
205315|NCT00529698|"     This Phase I study is directed at evaluating the safety profile (as a primary end-point) and     the immunogenicity (as a secondary end-point) of the recombinant HIV-1 Tat vaccine in     healthy, immunologically competent adult subjects without identifiable risk of HIV-1     infection.   "
205316|NCT00529711|"     Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG     subjects have shown an increase in several cardiac performance parameters, with lesser volume     of resuscitation fluid required to reach circulation volume, as compared to Sodium     Chloride.It also does not cause hyperchloremic acidosis, which is of value in treating shock     patients.      The primary objectives of this prospective, randomized, open-label trial are to evaluate the     clinical efficacy of hypertonic lactate in comparison to Ringer's lactate to maintain     hemodynamic stability in intra- and post-CABG subjects in relation to hemodynamic status and     body fluid balance, as well as to assess its safety in terms of lab parameters and occurrence     of adverse events.The secondary objectives are to evaluate comparative clinical efficacy of     the two fluids in relation to reduction in concomitant drug utilization, duration of     ventilator usage, length of stay in ICU as well as total duration of hospitalization and     neurocognitive status upto a period of 1 year post-CABG.   "
205317|NCT00529724|"     Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in     patients with motor complications. However, the post-operative body weight gain involved may     limit the benefits of surgery and induce critical metabolic disorder. The aim of this study     to determine the energy expenditure in usual conditions of life.   "
205318|NCT00529737|"     Primary Objective:      - To perform a prospective study to determine if there is a different in the marker clip     migration if the first post-biopsy mammogram was performed in the same projection as the core     biopsy versus in the orthogonal projection.   "
205319|NCT00529750|"     Primary:        -  To evaluate the impact of irbesartan on endothelial function in hypertensive patients          with metabolic syndrome.      Secondary:        -  To evaluate the oxidative stress status in patients with hypertension with metabolic          syndrome.        -  To correlate the oxidative stress status with endothelial function in these patients.        -  To evaluate the effect of irbesartan on the oxidative stress stage in patients with          metabolic syndrome and to correlate it with the effect on endothelial function .        -  To correlate the change in endothelial function and oxidative stress stage with the          change of arterial pressure levels.   "
205320|NCT00529763|"     The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate     to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR)     rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib,     or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP     CML and Ph+ALL).   "
205321|NCT00529776|"     Hypothesis: Ventilator associated pneumonia (VAP) in critically ill patients may be prevented     by continuous lateral rotation therapy (CLRT) using specially designed, motor driven beds.      Patients are randomized to CLRT or supine position if mechanically ventilated and not     suffering from pneumonia or ARDS within 48 hours after intubation. Prophylaxis of VAP is     standardized in both groups. Primary endpoint is incidence of VAP, secondary endpoints are     length of ventilation, length of stay and mortality.   "
205322|NCT00529789|"     The primary purpose of your participation in this study is to help answer the following     research question, and not to provide you treatment for your condition. Whether duloxetine     once daily orally is tolerated and safe, in children (aged 7 through 11 years) and     adolescents (aged 12 through 17 years) with Major Depressive Disorder.   "
205323|NCT00529802|"     The purpose of this study is to learn if PET scanning can predict the degree of tumor     shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.   "
205324|NCT00529815|"     The purpose of this pilot study is to determine if a Real-Time Continuous Glucose Monitoring     System (CGMS) is a more effective method of improving glycemic control in patients with type     2 diabetes than is episodic self blood glucose monitoring(SBGM) in the both the short- and     long-term. CGMS, which includes a sensor that can be self- inserted under the skin and a     discrete monitor that records and displays blood sugar levels nearly continuously, allows for     real time blood glucose monitoring. This will be a prospective, randomized control trial     comparing participants with type II diabetes use of CGMS versus SBGM. The primary endpoint     will be improvement of glycemic control as measured by glycosylated hemoglobin (A1C). The     secondary endpoints will compare mean daily glucose levels, the number of both hypoglycemic     and hyperglycemic events, the amount of time spent in target blood glucose, and the perceived     level of diabetes-related stress between the two groups. Participants will be randomized to     either the control (SBGM) or intervention (CGMS) group. Subjects in the intervention group     will alternate the use of the CGMS with episodic self blood glucose monitoring for four     cycles of two weeks during the 12 week study. The control group will perform episodic SBGM     throughout the study. The intensified monitoring schedules for both groups will end at the     end of week 12, but glycemic control measurement by A1C will continue through 52 weeks. A1C     levels will be drawn at 0, 12, 24, 38, and 52 weeks. Mean daily blood glucose levels, number     of hypo and hyperglycemic events, and duration of time spent in target blood glucose range     will be downloaded from patients' meters periodically throughout the study. The SF-8, a     general quality of life questionnaire for people with chronic disease, and Problem Areas in     Diabetes (PAID), a diabetes-related quality of life questionnaire, will be completed at the     beginning and end of the study. The results of this study may help highlight which blood     glucose monitoring methods are most likely to improve patients' ability to achieve and     maintain target levels of glycemic control.   "
205325|NCT00529828|"     The knowledge of the health effects of CLA on the human body is limited. However, CLA     supplements are sold over the counter in several countries and various techniques are used to     increase the content of CLA in food.      The CLARINeT study will be performed to investigate the effect of CLA on blood lipoproteins,     inflammatory markers, blood pressure and insulin status in human volunteers relative to     industrial trans fatty acids and to oleic acid.   "
205326|NCT00529841|"     The purpose of this study is to develop a more physiological approach to the management of     children and adolescents with salt wasting Congenital Adrenal Hyperplasia.      We will administer the glucocorticosteroid via insulin infusion pump to see whether this     treatment will improve the serum hormone concentrations.   "
205443|NCT00540488|"     To measure and compare the glycemic and insulinemic responses of subjects consuming a     standard and two diabetes-specific products.   "
207852|NCT00562783|"     Cirrhosis is a diffuse lesion characterized by architectural distortion of the liver because     of collagen deposition and development of nodules of regenerating hepatocytes. It is an     irreversible change that results from diseases characterized by chronic liver injury     (Fujimoto, 2000). Cirrhosis alters the pattern of blood flow through the liver and results in     impaired perfusion of hepatic lobules with intrahepatic and extrahepatic shunting of blood.     This deprives hepatocytes of uniform perfusion by arterial and portal venous blood resulting     in both portal hypertension and other consequences of cirrhosis including impaired protein     synthesis and altered drug metabolism. The histologic diagnosis of cirrhosis requires the     presence of regenerative nodules or pseudolobules completely encircled by fibrosis such as     congenital hepatic fibrosis can result in portal hypertension in the absence of cirrhosis     (Anthony et al., 1977).      The events leading to the development of cirrhosis are generally those of chronic injury with     hepatocyte destruction. Acute severe liver injury as in fulminant viral hepatitis does not     result in cirrhosis and the liver generally returns to normal after recovery. Cirrhosis can     be classified by macroscopic appearance, by cause, and by histologic appearance and location     of liver damage. Micronodular cirrhosis is composed of uniform nodules less than 3 mm in     diameter, whereas macronodular cirrhosis has varying size nodules greater than 3 mm diameter.     Mixed nodular cirrhosis has nodules of both sizes. Some liver diseases such as alcoholic     liver disease may present as micronodular cirrhosis and develop larger nodules with     subsequent regeneration of hepatocytes. For this reason, many prefer etiologic classification     (e.g., alcoholic cirrhosis). The designation of cirrhosis as post necrotic, biliary and     portal are still commonly used and imply predominant histologic location of fibrosis.      Cirrhosis is an irreversible disease, and attempts should be made to stabilize the patient     and to control the cause. Factors that indicate a poor outcome include an elevated     prothrombin time that does not correct itself with parenteral vitamin K, upper     gastrointestinal bleeding caused by varices, ascites refractory to therapy, increased age of     the patient, sever malnutrition, spontaneous bacterial peritonitis, a pronounced increase of     serum bilirubin in the absence of haemolysis, and heptocellular carcinoma (Yeh et al., 2003).     In general, all causes of upper GI bleeding are associated with an increased mortality in     patients with cirrhosis. For those with alcoholic cirrhosis who lack portal hypertension,     survival is similar to an age-matched cohort if alcohol intake is stopped (Nakamura et al.,     1991). If ethanol consumption continues, mortality is higher. Cirrhosis can be present     without clinically significant complications and be identified only at autopsy or during     evaluation of abnormal liver tests (Mendez et al., 2003). However, for many patients the     disease is slowly progressive resulting in one or more complications. The clinical     manifestations of cirrhosis are a result of altered hepatic blood flow through the liver with     intrahepatic shunting causing impaired perfusion of hepatocytes or portal hypertension with     shunting of blood around the liver though portosystemic communications. The major     complications of portal hypertension include oesophageal or gastric varices, ascites,     portosystemic encephalopathy, and hepatorenal-syndrome (Menon & Kamath, 2000). With     impairment of hepatocyte perfusion or reduction of hepatocyte number, altered synthetic     function can result in hypoalbuminemia, hypoprothrombinemia, and changes in drug metabolism.      Vitalliver is a Chinese medicine which is administered in the form of a suppository, which is     uncommon for most Chinese medicines. Medications released from the suppositories are absorbed     directly from the circulation around the rectum and then reach the liver via the portal vein.      Basic pharmacological studies have shown that Vitalliver has good immunomodulating functions,     increases the activities of T-cells, B-cells and NK cells, therefore this formulation may     have special values in treating liver diseases.   "
205327|NCT00529854|"     Accurate documentation in the patient medical record is critical to ensure proper diagnosis     coding and subsequent hospital reimbursement. Multiple studies have demonstrated that     clinicians often omit diagnoses which may result in insurance company denials and significant     delays in payment. In addition, omitting diagnoses decreases the severity of patient illness     which is often used as a risk adjustment tool to compare institution and physician outcomes.     Medical informatics has been used to help improve accurate diagnosis documentation as well as     improve billing efficiency. We plan to utilize a medical informatics program called SIC-IR     (Surgical Intensive Care - Infection Registry) to improve documentation and attending billing     efficiency within the surgical and trauma intensive care unit (STICU). We propose a six month     study: a three month observational evaluation of current billing procedures followed by a     three month prospective evaluation using a newly created SIC-IR billing module. The outcome     measures will include the number of ICD-9 and CPT codes at discharge per patient, severity of     patient illness based on documentation, STICU charges, number of insurance company denials,     DRG relative weights, as well as a qualitative assessment of attending physician use of the     electronic billing module. The observational and prospective patient populations will be     compared for total patient-days in the STICU, ventilator-days, antibiotic-days, infectious     complications per patient, and injury severity score (trauma patients only) to ensure the     populations are similar and only the documentation and billing changes can account for our     measured outcomes. We hypothesize that the SIC-IR billing module will increase the number of     patient ICD-9 and CPT codes at discharge, increase severity of STICU patient illness via     accurate documentation, increase total STICU charges, decrease insurance company denials, and     be an efficient and well accepted electronic medical application.   "
205328|NCT00529867|"     The purpose of this study is to compare the safety and efficacy in children aged 6 - 59     months with uncomplicated malaria, treated with either conventional artemether/lumefantrine     tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya   "
205329|NCT00529880|"     -  To determine the feasibility of fludarabine and cytarabine as continuous infusion plus          granulocyte-colony stimulating factor priming for elderly patients with resistant acute          myeloid leukemia other than acute promyelocytic leukemia        -  The feasibility will be evaluated in terms of toxicities, complete remission rate,          duration of complete remission, disease-free survival, and overall survival.   "
205330|NCT00529893|"     The purpose of this study is examine the efficacy of atomoxetine on executive functioning     measures including the Continuous Performance Test (CPT) and the executive function measures     of the Cambridge Automated Neuropsychological Test Automated Battery (CANTAB).   "
205331|NCT00529906|"     The ultimate goals of this study are to identify patterns of familial aggregation with     regards to categorical and dimensional approaches of ADHD and neuropsychological measures, to     validate the phenotypes and endophenotypes that are close to biological expression of genders     underlying ADHD, and to identify the genetic variants close to the etiological genes of ADHD     in Taiwanese sample. We propose to replicate the analysis of the candidate genes identified     by previous genetic studies on ADHD using the candidate gene association study design     (family-based case control study using parental controls) to validate the findings from other     research groups. With the accomplishment of these goals, this study will resolve     controversies over inconsistent findings in previous genetic studies and contribute to the     literature on the validity of ASD using clinical and genetic data.   "
205332|NCT00529919|"     The primary aim of this research project is to determine whether the incorporation of food     products containing medium chain triglyceride (MCT) oil in a weight-loss program results in a     different degree of weight-loss and total and regional fat mass loss than the incorporation     of extra light olive oil. The secondary goals are to test whether there are differences in in     metabolic risk profile changes between the 2 diets. We hypothesize that men and women who     consumed MCT oil as part of their weight loss program will lose more weight and body fat than     those who consume olive oil in their weight loss diet.   "
205333|NCT00529932|"     An international, multi-centre, double-blind, randomised, placebo-controlled clinical trial     with central core lab analyses to determine the safety of intra-coronary infusion of enriched     CD133+, bone marrow-derived, autologous progenitor cells in patients 5-10 days after acute     percutaneous coronary revascularization (primary PCI) for ST-segment elevation myocardial     infarction (STEMI).   "
205334|NCT00529945|"     The primary object of this study is to demonstrate the continued safety and performance of     the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic     stroke, transient ischemic attack, migraine or decompression illness.   "
205335|NCT00529958|"     The purpose of this randomized clinical trial is to determine the difference in quality of     life outcome at two years, in patients undergoing an Anterior Cruciate Ligament (ACL)     reconstruction procedure with either a patellar tendon, quadruple hamstring tendon or a     double-bundle hamstring tendon autograft.   "
205336|NCT00538681|"     This study is intended for patients with advanced, not amenable to surgery, or metastatic     lung cancer who have not received any prior chemotherapy. The study will be conducted in 2     parts:        -  Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin          combination chemotherapy        -  Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin +          enzastaurin versus pemetrexed + cisplatin + placebo. Patients to be included in Part 2          are those with Nonsquamous NSCLC.   "
205337|NCT00538694|"     To evaluate the safety and efficacy of daptomycin in adults who have pneumonia due to     Streptococcus pneumoniae.   "
205338|NCT00538707|"     The aim of the project is to study the acute and chronic effect of mental stress on platelet     adhesion and aggregation in two population composed of normal subjects at different ages   "
205339|NCT00538720|"     The goal of this clinical research study is to learn how the standard practice of giving     Vitamin D supplements to patients with a Vitamin D deficiency may affect the size of the     parathyroid glands in patients with PHPT and a Vitamin D deficiency.   "
205340|NCT00538733|"     Study Objectives        1. Evaluate the efficacy of the combination of thalidomide (Thalomid®), clarithromycin          (Biaxin®), lenalidomide (Revlimid®), and dexamethasone (Decadron®) as an induction          therapy for patients with newly diagnosed multiple myeloma (MM).        2. Evaluate the efficacy of the addition of thalidomide (Thalomid®) to BiRD combination          therapy as a therapy to increase the complete response rate for patients with newly          diagnosed multiple myeloma.        3. Evaluate the safety of the combination of clarithromycin, lenalidomide, dexamethasone,          and thalidomide as a therapy for patients with newly diagnosed MM   "
205384|NCT00539721|"     This is a multicenter, randomized, controlled study in women who are having elective open     abdominal surgery with general anesthesia and who are expected to need patient-controlled     analgesia (PCA) after surgery. The primary objective is to assess the effect of rolapitant in     the prevention of postoperative nausea and vomiting as measured by the prevention of vomiting     in the first 24 hours after surgery. Participation in the study may last up to 3 months. The     total duration of the study will be approximately 36 weeks.   "
205341|NCT00538746|"     Most patients admitted to intensive care units require mechanical ventilation. Weaning from     assisted/controlled ventilation begins when we recognize that the patient has recovered     adeguately from acute respiratory failure.      If weaning is delayed, costs are increased, as are the risks of nosocomial pneumonia,     cardiac-associated morbility, and death. On the other hand, weaning too soon often results in     reintubation, which is associated with complications similar to those of prolonged     ventilation.      The aim of this trial is to establish an evidence-based approach to weaning and to determine     when a patient is ready to be weaned from mechanical ventilation, and what is the best     weaning technique.   "
205342|NCT00538759|"     The objective of the RADAR trial is to determine the impact of External Beam Radiation     Therapy (EBRT) on aortic valve restenosis following successful percutaneous balloon aortic     valvuloplasty (BAV) in elderly patients with severe calcific aortic stenosis.   "
205343|NCT00538772|"     Purpose:      The purpose of the correlative studies is to evaluate levels of serum factors of circulating     VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at     baseline and over the course of initial treatment in order to explore relationships with     baseline patient factors, measurable disease response and clinical progression.      Hypothesis soluble markers of angiogenic growth factors and receptors, and circulating     endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or     sorafenib.   "
205344|NCT00538785|"     The primary goal was to describe the safety of the investigational product when given monthly     to prevent serious respiratory infection among children with significant heart disease.   "
205345|NCT00538798|"     The metabotropic glutamate subtype five (mGluR5) receptor is a protein found in the brain and     is the target for the excitatory chemical messenger glutimate. The purpose of this protocol     is to measure mGluR5 receptors in the brain using positron emission tomography (PET) and a     research drug called [18F]SP203.   "
205346|NCT00538811|"     When administered simultaneously, interferon-alpha 2b + interferon-gamma result in dramatic     antiviral synergy.Ribavirin has shown to enhance interferon-gamma levels in patients with     chronic hepatitis C treated with interferon-alpha. Enhancement of immune responses,     especially those related to type-1 T helper cell activity, may contribute to better efficacy     in combining ribavirin with IFN-alpha for treatment of chronic hepatitis C. The aim of the     present study is to evaluate the efficacy and safety of a triple regimen, a combination     treatment with Interferon gamma, Interferon alfa-2b plus Ribavirin in patients who have not     previously responded to interferon alpha in combination of ribavirin.   "
205347|NCT00538824|"     Study Objectives        1. To evaluate the efficacy of the combination of dexamethasone (Decadron®), thalidomide          (Thalomid®), and lenalidomide (Revlimid®) as therapy for patients with relapsed or          refractory multiple myeloma (MM) who have failed prior treatment with both lenalidomide          and thalidomide when used as monotherapies.        2. To evaluate the safety of the combination of lenalidomide, dexamethasone, and          thalidomide as a therapy for patients with relapsed or refractory multiple myeloma.   "
205348|NCT00538850|"     This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the     clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.     The study medication is administered under the tongue as a simple spray and can be     self-administered by patients or assisted by their caregivers. Patients are titrated to an     effective-dose of fentanyl sublingual spray in the open-label titration period and then     proceed to the double-blind randomized period where they randomly receive 7 treatments with     fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a     total of 6-7 weeks (including both the open-label titration and the double-blind randomized     periods).   "
205349|NCT00538863|"     The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for     the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their     persistent cancer pain.   "
205350|NCT00538876|"     This is an open label phase I study designed to explore the feasibility, safety and biologic     activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin     induction chemotherapy in younger patients with less-than-favorable risk AML.      Primary Objective: To find an appropriate dose level for decitabine when used as priming for     cytarabine and daunorubicin 7+3 induction chemotherapy in AML.      Secondary Objectives:        1. To establish the safety and expected toxicities of decitabine when used as priming for          cytarabine and daunorubicin 7+3 induction chemotherapy in AML.        2. To establish the optimal dose schedule of decitabine required to broadly demethylate          cytosine residues in genomic regulatory regions.        3. To investigate, in selected cases, the molecular and cellular consequences of          decitabine-induced hypomethylation by a) establishing the extent and degree of          hypomethylation at specific genomic loci required to reactivate the expression of          repressed genes and by b) determining the effect of hypomethylation on the          differentiation and/or apoptosis of leukemic blasts.   "
205351|NCT00538889|"     To assess the safety and tolerability of lecozotan SR and citalopram when coadministred to     healthy subjects.   "
205352|NCT00538902|"     A study to assess the safety and efficacy of adalimumab administered as a subcutaneous     injection in adult Chinese subjects with rheumatoid arthritis and treated with methotrexate   "
205353|NCT00538915|"     The purpose of this study is to determine if NABI-IGIV (10%) [Immune Globulin Intravenous     (Human), 10%] is safe and effective in preventing serious bacterial infections (SBIs) in the     treatment of patients with primary immune deficiency disorders (PIDD) when compared to     historical control data.   "
205354|NCT00538928|"     A prospective, randomized study will be performed investigating the effects of a pumpless     extracorporeal interventional lung assist [iLA] on the implementation of a lung-protective     ventilatory strategy in patients with acute respiratory distress syndrome [ARDS] with a     PaO2/FiO2 ratio < 200. The duration of ventilation, intensive care and hospital stay and     in-hospital mortality will be investigated.   "
205385|NCT00539734|"     Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal     growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits     the growth of new vessels and has recently been approved by FDA for treating this condition.     This study is carried out to evaluate the changes in retinal function after an injection of     ranibizumab.   "
205355|NCT00538941|"     The aim of the present study is to investigate whether in patients with chronic heart failure     endothelial dysfunction and baroreceptor function is altered by ingestion of a flavonoid-rich     dark chocolate in comparison to placebo chocolate (Nestlé Placebo Chocolate) on top of     standard medication.      Moreover, we will evaluate the effect of chocolate on oxidative stress, platelet adhesion as     well as systemic inflammatory response such as C-reactive protein and pro-inflammatory     cytokines in patients with chronic heart failure.   "
205356|NCT00538954|"     Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled     pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS)     programmes are perioperative care pathways that address systematically these issues (i.e.     improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to     promote a faster recovery and a shorter stay. The key treatments that improve outcome within     an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to     assess key outcome variables such as return of GI function. This randomised trial will assess     the potential synergy between early recovery of GI function (laxation) and early     postoperative oral nutritional support(with associated preoperative preconditioning using     carbohydrate/fluid loading). The main overall outcome targets being improved recovery of     gastrointestinal function, postoperative nutritional status and physical function. It will     validate the use of a novel, objective technique to measure gastric motility (surrogate for     GI function). Such refinement of ERAS should result in shorter hospital stay and better use     of limited health care resource.   "
205357|NCT00538967|"     The matrix metalloproteinase-9 (MMP-9) is considered to play a central role in abdominal     aortic aneurysm (AAA) initiation. Doxycycline has direct MMP-9 inhibiting properties in     vitro, and it effectively suppresses AAA development in rodents. Observed inhibition of AAA     progression, and contradictory findings in human studies evaluating the effect of doxycycline     therapy on aortic wall MMP-9 suggest that the effects of doxycycline extend beyond MMP-9     inhibition, and that the effect may be dose dependent.   "
205358|NCT00538980|"     The purpose for conducting this research study is to determine the feasibility of using     dasatinib as a treatment for polycythemia vera and to determine the optimum treatment     regimen.   "
205359|NCT00538993|"     Hypothesis: HIV clinicians trained to deliver brief counseling messages and receiving cues     from a brief computer survey on risk behaviors of their patients can counsel have an impact     on patient's risk behaviors.   "
205360|NCT00539006|"     The purpose of this replicate study to FFU105927 is to provide data on subject preference of     FFNS as compared with FPNS.   "
205361|NCT00539019|"     The investigators are collecting information on the calorie needs of patients in the first     year postburn. The investigators hypothesize that increased energy needs continue for up to a     year following wound closure from burn injury.   "
205362|NCT00539409|"     The purpose of this study is to determine if restoring normal metabolic function in patients     with either type I or type II diabetes can improve the impact of the consequences of diabetic     complications on the overall quality of life of diabetic patients. Patients are treated once     a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A     diabetic quality of life questionnaire is completed prior to the start of the treatment and     quarterly thereafter with detailed analysis performed to measure progress and outcomes   "
205363|NCT00539422|"     The aim of our study is to investigate the potential role of the CYP2D6*4 polymorphism in     breast cancer and furthermore to assess the role of oxidative stress, antioxidant capacity     and ferretin in pathogenesis of breast cancer in different CYP2D6*4 genotypes   "
205364|NCT00539435|"     The purpose of this study is to determine if restoring normal metabolic function in patients     with either type I or type II diabetes can improve the impact of the consequences of diabetic     complications on heart disease in diabetic patients. Patients are treated once a week with     pulsatile intravenous insulin therapy mimicking normal insulin secretion. A diabetic cardiac     disease quality of life questionnaire is completed prior to the start of the treatment and     monthly thereafter with detailed analysis performed to measure progress and outcomes. A     carotid ultrasound and echocardiogram are performed at baseline and every six months to     monitor progress.   "
205365|NCT00539448|"     Primary objective :      To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then     after 13 weeks & at the end of the study which will be after 26 weeks) in subjects with type     I diabetes mellitus.      Secondary objective :        -  Recording the average daily dose of both insulin Glulisine & insulin Glargine in type I          DM.        -  Recording adverse events.   "
205366|NCT00539461|"     In this German non-interventional observational study 1980 patients diagnosed with Restless     Legs Syndrome (RLS) will be investigated by 990 General Practitioners across all federal     states in Germany. Both moderate to severe RLS patients, with or without previous RLS     treatment, suffering from RLS symptoms like a desire to move the extremities usually     associated with some discomfort, motor restlessness and worsening of symptoms at rest with at     least temporary relief by activity, worsening of symptoms later in the day or at night, are     eligible for this study, if it is planned to initiate therapy with pramipexole or to add     pramipexole to a previously given, insufficient therapy. Three visits are planned to be     documented in this PMS study, one baseline visit, visit two after the end of pramipexole     titration and visit three after 12 weeks of treatment. Evaluations and visits are to be     carried out and documented only if part of routine medical practice. The main goal of     observational studies is to determine how pramipexole treatment works when applied in actual     practice and thus maximise external validity. In actual practice patients who have been     excluded in the clinical registration trials of PPX in moderate to severe primary RLS (i.e.     those with certain disease histories, co-morbidities and/or demographic characteristics) will     be treated with PPX. Thus in addition during this observational study information on the     efficacy and safety of PPX in those patients will be obtained. The objectives of this PMS     study are:        -  To evaluate the treatment effect of pramipexole on RLS severity and general improvement          as measured by IRLS and CGI-I.        -  To evaluate quality of life of RLS patients as measured by the Restless Legs Syndrome          Quality of Life questionnaire (RLS-QoL).        -  To evaluate the safety profile of PPX in a natural study population.   "
205367|NCT00539474|"     Rationale:      Approximately 25% of breast cancers detected are non palpable. Accordingly, a localization     technique is required to help the surgeon to find and remove the cancer. The current     technique (wire guided localization [WGL]) is difficult to perform and has a high rate of     tumour positive margins in the resected specimen, requiring a second operation. A new     approach in the localization and resection of non-palpable malignant breast lesions is 'radio     guided occult lesion localization' (ROLL). ROLL was introduced as a possible replacement for     WGL at the `European Institute of Oncology' in Milan in 1996. This technique utilizes the     intratumourally injected radiotracer, that is generally used for the lymphatic mapping and     SNB, to localize the primary tumour guided by the gamma probe. Five studies so far have     proven the applicability of this method.      Objective:      To evaluate the efficacy of Radio Occult Lesion Localisation (ROLL) versus Wire guided     Localisation (WGL) in breast conserving surgery for non-palpable breast cancer      Study design:      A multicenter, prospective randomized clinical trial. Patients with proven non-palpable     breast cancer will be randomized for either ROLL or WGL.      Study population:      316 women with a core biopsy proven non palpable cT1 breast carcinoma that are eligible for a     breast conserving treatment and sentinel node biopsy (SNB).      Intervention (if applicable):      Patients in the WGL group will undergo intra tumoural injection of a nuclear radiotracer     under stereotactic or ultrasonographic guidance. After scintigraphic imaging, to monitor the     migration of the radiotracer, a guide wire will be inserted under stereotactic or     ultrasonographic guidance. The excision of the primary tumour is guided by the inserted wire     and the sentinel node procedure is performed using a gamma probe and intratumoural injection     of patent blue.      Patients in the ROLL group will undergo the same procedure except for the guide wire     insertion. The excision of the primary tumour is guided by the gamma probe.      Main study parameters/endpoints:      Primary study endpoints; ROLL vs WGL:        1. The percentage of tumour-free margins (invasive and in situ)        2. The volume and maximum diameter of the lumpectomy      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      There is no pre-, per- or post operative extra burden. The radiofarmacon is already used in     the standard care of breast cancer patients for the sentinel node biopsy. The used     radio-active substance does not damage the patient.      A specific burden questionnaire, aimed at evaluating the burden of the cosmetic result, will     be administered. To further assess the net impact in terms of Health Related Quality of Life     (HRQoL) also the EQ5D will be obtained at T = 0, 6, 12 and 26 weeks after the initial     diagnostic work-up.      Should the results indicate that overall the WGL procedure lead to better clinical outcome a     cost-effectiveness analysis is foreseen using bootstrapping to assess the uncertainty with     regard to the balance between costs and effects. All analyses will be limited to a half year     time horizon. Accordingly, discounting of costs or effects is not applicable.   "
205368|NCT00539487|"     This observational non-interventional study will assess (under conditions of clinical     practice in daily routine) the antihypertensive efficacy of telmisartan treatment with or     without active promotion of lifestyle changes in hypertensive patients at high cardiovascular     risk   "
205369|NCT00539500|"     The goal of this clinical research study is to learn how long it takes for certain types of     transplanted stem cells to produce new blood cells. The safety of this treatment will also be     studied. Finally, researchers want to learn if collecting the cells with the CliniMACS device     can decrease the possibility of tumor cells contaminating (appearing in) the stem cells that     are reinfused into participants.   "
205370|NCT00539513|"     Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal     of suffering. Many patients benefit from established treatments, the mainstay of which are     cognitive behavioral therapy and a group of antidepressant medications known as serotonin     reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established     therapeutic strategies. New avenues of treatment are urgently needed.      Existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin     or dopamine; but increasing evidence suggests that functional disruptions of a different     neurotransmitter, glutamate, may contribute to some cases of OCD. The researchers are     therefore interested in using medications that target glutamate as novel treatment options     for those OCD patients who do not benefit from established treatments.      One such medication is the drug N-Acetylcysteine, whose glutamatergic antagonistic properties     may be effective in reducing the glutamatergic hyperactivity that is thought to contribute to     the pathophysiology of OCD and major depressive disorder (MDD).      Riluzole, which is FDA approved for amyotrophic lateral sclerosis (ALS, or Lou Gehrig's     disease) is also a glutamatergic agent. There is evidence that riluzole possesses     anti-depressant, anti-obsessional, and anti-anxiety properties.      The modulation of glutamatergic activity is a promising new approach to the treatment of mood     disorders. The researchers are therefore now recruiting patients to participate in a     double-blind, placebo-controlled trial of N-Acetylcysteine, added to whatever other OCD     medications they are taking.   "
205371|NCT00539526|"     This study will evaluate hyperemia and ocular surface tolerability in patients on     prostaglandin analogues   "
205372|NCT00539539|"     The purpose of this study is to evaluate whether or not real-time feedback on CPR process     variables will increase rates of restoration of spontaneous circulation during prehospital     resuscitation and upon arrival at the receiving emergency room as well as increase rates of     survival to hospital discharge.   "
205373|NCT00539565|"     Biliary atresia is a congenital disorder of bile duct development or destruction of     established but immature bile ducts. The study tests the hypothesis that post-operative     steroids improve outcome following the Kasai procedure - the commonest surgical treatment.   "
205374|NCT00539578|"     The purpose of the study is to examine the safety and efficacy of MK0777 during treatment for     Generalized Anxiety Disorder.   "
205375|NCT00539591|"     The main goal of this study is to estimate the tumor response rate of temozolomide     administered in combination with peginterferon alfa-2b to pediatric patients with     unresectable Stage III, metastatic, or recurrent cutaneous melanoma.   "
205376|NCT00539604|"     To determine if 16-64 slice multidetector CT (MDCT) can replace the invasive procedure in     patients scheduled for coronary angiography in order to exclude the presence of CAD   "
205377|NCT00539617|"     The purpose of this study is to test the safety and effectiveness of erlotinib and FOLFOX in     patients with esophageal or gastro-esophageal cancer that cannot be removed by surgery.   "
205378|NCT00539630|"     To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU,     versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.   "
205379|NCT00539643|"     The purpose of this study is to evaluate the effect of blocking the blood vessels to the     tumor in your liver with small beads alone (Bead Block) versus blocking them with the same     bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study     is to see if adding doxorubicin kills more tumor than would be killed by just blocking the     blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to     treat patients with cancer. This procedure to block the blood vessels is called embolization.     Embolization is a common treatment for patients with liver cancer who cannot have surgery.     The investigators are comparing the standard treatment (using the small beads alone) with     another that should be at least as good, but possibly better (with the addition of the drug,     doxorubicin). There is no guarantee that the new treatment is better and it is possible that     there might be more side effects (related to the doxorubicin) than what is seen with the     standard treatment.   "
205380|NCT00539656|"     This study is to evaluate the safety of transplantation of two cord blood products, including     toxicities in patients following high-dose, myeloablative chemotherapy for blood     malignancies. It is also to determine if the use of two cord products results in an     improvement in neutrophil engraftment.   "
205381|NCT00539669|"     Evaluate response rate of Docetaxel in combination with Carboplatin or Cisplatin as first     line chemotherapy in epithelial ovarian cancer. Assess the progression free survival,     tolerance, duration of response and survival in the same patient population.   "
205382|NCT00539695|"     Patients are being asked to participate in this study because treatment for their disease     requires a stem cell transplant (SCT). Stem cells are the source of normal blood cells found     in the bone marrow and lead to recovery of blood counts after bone marrow transplantation.     With stem cell transplants, regardless of whether the donor is a full match to the patient or     not, there is a risk of developing graft-versus-host disease (GVHD).      GVHD is a serious and sometimes fatal side effect of SCT. GVHD occurs when the new donor stem     cells (graft) recognizes that the body tissues of the patient (host) are different from those     of the donor. When this happens, cells in the graft may attack the host organs. How much this     happens and how severe the GVHD is depends on many things, including how different the donors     cells are, the strength of the drugs given in preparation for the transplant, the quality of     transplanted cells and the age of the person receiving the transplant.      Typically, acute GVHD occurs in the first 100 days following transplant, while chronic GVHD     occurs after day 100. Acute GVHD most often involves the skin, where it can cause anywhere     from a mild rash to complete removal of skin; liver, where it can anywhere from a rise in     liver function tests to liver failure; and the gut, where it can cause anywhere from mild     diarrhea to profuse, life-threatening diarrhea. Most patients who develop GVHD experience a     mild to moderate form, but some patients develop the severe, life-threatening form.      Previous studies have shown that patients who receive SCT's can have a lower number of     special T cells in their blood, called regulatory T cells, than people who have not received     stem cell transplants. When regulatory T cells are low, there appears to be an increased rate     of severe, acute GVHD. A drug known as IL-2 (Proleukin) has been shown to increase the number     of regulatory T cells in patients following stem cell transplant, and in this study     investigators plan to give low dose IL-2 after transplant.      This study is called a phase II study because its major purpose is to find out whether using     a low-dose of IL-2 will be effective in preventing acute GVHD. Other important purposes are     to find out if this treatment helps the patient's immune system recover regulatory T cells     faster after the transplant. This study will assess the safety and toxicity of low-dose IL-2     given to patients after transplantation and determine whether this drug is helpful in     preventing GVHD.   "
205383|NCT00539708|"     The purpose of this study is to assess the efficacy of noninvasive ventilation in the     prevention of extubation failure and mortality in patients with chronic respiratory disorders     and hypercapnic respiratory failure during spontaneous breathing.   "
205413|NCT00540098|"     Efficacy and safety of a 10-weeks treatment protocol of paroxetine vs. placebo in combination     with regular aerobic exercise (running) or regular relaxation training in the treatment of     panic disorder.   "
205386|NCT00539747|"     This exploratory study will examine ways in which individuals approach a positive genetic     test for Huntington Disease (HD). HD is a neurodegenerative disorder that causes emotional,     cognitive, and movement problems, and currently there is no way to prevent, stop or reverse     the progression of the disease. It is passed down through a mutation in a normal gene, and     each child of an HD parent has a 50-50 chance of inheriting the HD gene. The study is     designed to explore how individuals adjust to their new genetic status and evaluate any     perceived mental or emotional barriers to that adjustment. Currently, little is known about     how individuals come to terms with a positive genetic test result for a condition that has no     known cure or effective treatment. The results of this study may give health care providers     and counselors more information about how to help patients who are at risk for developing HD     make sense of their new genetic status.      Candidates will be prescreened and referred to the study by clinics that specialize in     genetic testing and counseling. Candidates must be 18 years old or older and must have     received a positive genetic test result for HD at least one month prior to the study. They     must also perceive themselves to be asymptomatic-that is, without existing HD symptoms.      During the study, participants will be interviewed and asked a series of questions about     their decision to pursue testing, their life since the testing, and the things that they have     found helpful or unhelpful since receiving the test results. The interviews will be recorded     and will last approximately 60 minutes. Participants also will receive a follow-up phone call     within two to three days to ensure their general psychological well-being after the     interview.   "
205387|NCT00539760|"     GSK182771 is a domain antibody targeting the interleukin (IL)-1 receptor which is being     developed for the treatment of rheumatoid arthritis. This study is being done in healthy     volunteers to verify the safety and tolerability of GSK182771   "
205388|NCT00539773|"     Phase II Trial of concurrent administration of intravesical BCG & Interferon in the treatment     and prevention of recurrence of superficial transitional carcinoma of the urinary bladder.   "
205389|NCT00539786|"     PPI test;empirical trial with high-dose proton-pump inhibitors (PPIs) has been shown to be a     sensitive tool for diagnosing patients with GERD. However, this diagnostic strategy has not     been well established in patients with extraesophageal manifestation of GERD. In this study,     we aim to see the relevance of PPI test in diagnosing GERD in patients with extraesophageal     symptoms.   "
205390|NCT00539799|"     There is debate as to whether long-term low-dose steroids such as prednisolone help to     suppress relapses of systemic lupus erythematosus (SLE) in patients who are in remission from     their lupus nephritis. If low-dose prednisolone reduces relapses, these beneficial effects     may be counter-balanced by the long-term side-effects associated with prednisolone. This     pilot study will determine the feasibility of conducting a larger randomized control trial     that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5     mg/day) reduces the flares of SLE in patients with previous lupus nephritis.   "
205391|NCT00539812|"     The purpose of this study is to examine whether adding a brief alcohol treatment to standard     violence intervention programs for women will result in reduced drinking, reduced partner     violence perpetration, and reduced partner violence victimization. We hypothesize that,     relative to standard care, women receiving the additional brief alcohol intervention will     have better alcohol use and partner violence outcomes.   "
205392|NCT00539825|"     GSK704838C is a potent, pan-active mAChR antagonist, which is being developed for once-daily     treatment of chronic obstructive pulmonary disease (COPD).   "
205393|NCT00539838|"     This is a Phase III, randomized, double blind, placebo-controlled, multicenter,     parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo     when combined with a single stable background immunosuppressive medication and a     corticosteroid regimen in patients with moderately to severely active systemic lupus     erythematosus, who do not have moderate to severe glomerulonephritis.   "
205394|NCT00539851|"     This study is proposed to investigate the incidence of Post Transplant Diabetes Mellitus     (PTDM) as well as associated risk factors for the development of PTDM in patients undergoing     allogenic stem cell transplantation.   "
205395|NCT00539864|"     The purpose of this study was to evaluate and compare the safety, reactogenicity,     immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent     influenza vaccine (TIV)in healthy adults age 50-64 years.   "
205396|NCT00539877|"     Stomach cancer is the most common cancer, and is still leading cause of death in Korea.     Peritoneal seeding is the most common metastases of gastric cancer, and is the most frequent     cause of death from this disease. In addition, there is no standard treatment for peritoneal     dissemination. Even though systemic intravenous chemotherapy is the standard treatment for     metastatic stomach cancer at present, it does not improve the survival of patients with     peritoneal dissemination. Because intraperitoneal(IP) administration results in high     concentration locally with low systemic toxicity, clinical investigators have confirmed the     safety and pharmacokinetic advantage associated with IP delivery of a number of     antineoplastic agents with known activity in cancer. In ovarian cancer, a large randomized     trial demonstrated a small but statistically and clinically significant survival advantage     for women receiving a portion of their therapy intraperitoneally. Drugs such as     5-fluorouracil, cisplatin, mitomycin-C, paclitaxel and docetaxel are used for IP chemotherapy     in patients with gastric cancer. Even the small number of phase III trials reported, some     studies showed improvement in survival for patients randomized to IP therapy compared to     those receiving no postoperative treatment.     Irinotecan(7-ethyl-10-[4-(1-pipperidino)-1-piperidino] carbonyloxy camptothecin; CPT-11),     clinically effective in the treatment of colorectal, lung and gastric cancer, is a carbamate     prodrug metabolized to its active metabolite, 7-ethyl-10-hydroxycamptothecin (SN-38). In     mouse model, IP administration of CPT-11 was significantly more effective than intravenous     administration for control of both peritoneal seeding and liver metastasis. However,     phamacokinetics of CPT-11 with peritoneal administration in human beings is not well studied.     Although Japanese investigators reported pharmacokinetic data of CPT-11 with few patients,     there is no data about maximum tolerated dose of CPT-11 intraperitoneally.   "
205397|NCT00539890|"     To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting,     subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c     >7.0% and <11.5%.   "
205398|NCT00539903|"     There is today a growing need for culturally adapted initiatives among immigrants to prevent     and treat T2D. Others have failed to increase the level of physical activity in this sedate     group. The investigators believe this is due to missing assistance and lack of influence from     the Pakistani milieu. To improve this, a culturally adapted physical activity will be     established in this project in close cooperation with the Pakistanis themselves.      Through this program it is the investigators' goal to increase their physical activity level     and prevent lifestyle diseases among Pakistanis in Oslo with a high risk of developing these     diseases.   "
224128|NCT00779025|"     The purpose of this study is to study in couples and to evaluate the safety of personal     lubricant products.   "
205399|NCT00539916|"     Epidemiological studies definitively show that fruit and vegetable consumption is positive     for health and more specifically for cardiovascular diseases (CVD) prevention. In France,     among fruits, those which are the most frequently consumed are citrus fruits essentially as     juices and more specifically as orange juices. However, their health effects have been poorly     studied so far. Citrus fruits contain vitamin C associated with various phytomicronutrients     i.e. carotenoids (essentially -cryptoxanthin) and polyphenols. Each fruit contains specific     compounds: hesperetin in orange, naringenin in grapefruit, eriodyctiol in lemon. Some     scientific studies performed either in vitro or in animal models demonstrated properties of     these micronutrients which could contribute to a positive health effect of citrus fruits on     vascular protection. However data are still missing.      The main goal of this project is to characterize the effect of orange juice consumption on     vascular disease risk factors and to evaluate the specific role of their micronutrient     compounds (polyphenols and carotenoids) in this protection. To reach this goal, a randomized     cross-over clinical study will be performed on volunteers presenting a mild     hypercholesterolemia. They will consume for 4 weeks an orange juice or a reconstituted drink     similar to the orange juice for its composition in carbohydrates, minerals, vitamin C and     folates but without phytomicronutrients. The effect of the juice consumption on the vascular     function will be monitored exploring lipid abnormalities in plasma, measuring endothelial     vasoreactivity (FMD) (Flow Mediated Dilatation), as well as endothelial dysfunction,     thrombosis, inflammation and oxidative stress biomarkers in plasma. Comparison of urinary     metabolomes after orange juice consumption or that of the reconstituted drink will lead to     the identification of the metabolic pathways modulated by the orange juice micronutrients.      Moreover ELISA tests for the two major flavanones from citrus fruits (hesperetin and     naringenin) will be developed. They will be used to determine the plasma levels of these     molecules in order to analyze the relation ingested quantity - bioavailable quantity -     physiological effect.      The results obtained in this project will allow clarifying citrus fruit effects, and     particularly orange juice, in vascular protection.   "
205400|NCT00539929|"     This is a double-blind, multicenter study to assess the efficacy and safety of E6201 topical     administration to pre-identified marker lesions in adult subjects with chronic plaque type     psoriasis. Treatment duration is 8 weeks, followed by a 4-week period without treatment.     Pharmacokinetic samples will be obtained pre-and post treatment.   "
205401|NCT00539942|"     This is a randomized trial to compare intermittent compression devices with or without     post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for     known or presumed gynecologic malignancies. This trial seeks to determine if there is a     difference in the rate of deep venous thrombosis between these two groups.   "
205402|NCT00539955|"     The goal of this project is to examine whether, relative to standard care, violence and     alcohol use outcomes can be improved by a brief, motivationally based adjunct alcohol     treatment for men enrolled in batterer intervention programs. We hypothesize that men     randomized to also receive the brief alcohol intervention will have better partner violence     and alcohol use outcomes than men who are randomized to the batterer intervention program     alone.   "
205403|NCT00539968|"     This study will determine the best doses of docetaxel and lonafarnib when the two anti-cancer     agents are used in combination. Patients with tumors for which treatment with docetaxel would     be appropriate are eligible. A second part of the study will further examine the     effectiveness of the combination treatment in men with prostate cancer.   "
205404|NCT00539981|"     The purpose of this study was to evaluate a single dose of FluBlok in terms of safety,     efficacy and effectiveness in prevention of influenza and influenza-like illness and assess     clinical lot-to-lot consistency in manufacturing by evaluating and comparing the     immunogenicity of three different lots of FluBlok in a subset of subjects.   "
205405|NCT00539994|"     This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the     safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3     or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S.     aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be     enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19     intermittent carriers complete the study. Each eligible subject will participate in three     screening visits, a treatment period, and two follow-up visits. Each subject's participation     in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit.     Subjects will participate in up to three screening visits to determine S. aureus culture     positivity and colonization status.   "
205406|NCT00540007|"     The purpose of this study is to determine the efficacy of lenalidomide in the treatment of     relapsed or refractory classic Hodgkin lymphoma(cHL).   "
205407|NCT00540020|"     Context: Traumatic brain injury (TBI) is a common condition associated with significant     long-term cognitive, behavioral, and functional morbidities. There are minimal controlled     efficacy data of various acute rehabilitation intervention approaches.      Objective: To determine the relative efficacy of two different acute TBI rehabilitation     approaches - cognitive-didactic versus functional-experiential. Secondarily to determine     relative efficacy for different patient subpopulations based on baseline cognitive     functioning.   "
205408|NCT00540033|"     We investigate the efficacy of probiotics in reducing the incidence and severity of     necrotizing enterocolitis (NEC) for very low birth weight (VLBW) infants.A prospective,     masked, multi-center randomized control trial will be conducted level III neonatal center to     evaluate the beneficial effects of probiotics for NEC among VLBW (<1500 g) infants. VLBW     infants who start to feed enterally are eligible and are randomized into 2 groups after     parental informed consents were obtained. Infants in the study group are fed with Infloran     (Lactobacillus acidophilus and Bifidobacterium bifidus) with breast or formula milk twice     daily for 6 weeks. Infants in the control group are fed with breast or formula milk alone.     The clinicians caring for the infants are blinded to the group assignment. The primary     outcome measurement is death or NEC (≧stage 2).   "
205409|NCT00540046|"     The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380     IUD after termination of pregnancy after 12 weeks.   "
205410|NCT00540059|"     Purpose of this study is the evaluation of QoL, tolerability and use of Zoladex 10,8     SafeSystem for advanced PCa under naturalistic conditions   "
205411|NCT00540072|"     A COMPARASON OF CIDECIN™ (DAPTOMYCIN) TO ROCEPHIN® (CEFTRIAXONE) IN THE TREATMENT OF MODERATE     TO SEVERE COMMUNITY-ACQUIRED ACUTE BACTERIAL PNEUMONIA DUE TO S. PNEUMONIAE   "
205412|NCT00540085|"     Aim: To optimize the use of rocuronium (a neuromuscular blocking agent) in obese patients     undergoing gastric bypass or gastric banding.      Background: During general anaesthesia, a neuromuscular blocking agent is needed to allow     surgery and airway management. Optimal dosing is important in order to avoid inadequately     muscle relaxation, but also to avoid overdosage, which can result in prolonged anaesthesia     and respiratory complications.      Main hypothesis: Rocuronium dosed according to ideal body weight results in shorter duration     of action compared to rocuronium dosed according to corrected body weight without prolonged     onset time or compromised airway management or surgical demands for muscle relaxation.   "
205416|NCT00540137|"     The purpose of this study is to investigate the possibility of an association between changes     in neurocognitive function, as measured by a computerised test battery, and the use of two     different highly active antiretroviral therapy (HAART) regimens in treatment naïve HIV-1     infected subjects commencing antiretroviral therapy.   "
205417|NCT00540150|"     We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in     contrast to the standard specific immunotherapy.      Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22     patients for 6 weeks with the shortened scheme.   "
205418|NCT00540163|"     This observational non-interventional study is designed to demonstrate the improvement of     physical function in COPD patients with exercise-induced dyspnoea on treatment with Spiriva     (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.   "
205419|NCT00540176|"     Malignant gliomas, which include Glioblastoma multiforme (GBM), are the most common and most     aggressive types of brain cancer, accounting for approximately 60% of primary brain tumors.     These tumors are characterized by diverse molecular abnormalities (within the same tumor),     which, along with the difficulties of many standard chemotherapies crossing the blood     barrier, contribute to the very poor response to therapy and poor survival.      We recently showed that Dichloroacetate (DCA, an inhibitor of the mitochondrial pyruvate     dehydrogenase kinase) was able to depolarize cancer (but not normal) mitochondria and induce     apoptosis in cancer but not normal tissues. We believe that altering the metabolism of     cancers like glioblastoma (DCA switches metabolism from the cytoplasmic glycolysis to the     mitochondrial glucose oxidation) we inhibit the resistance to apoptosis that characterizes     cancer. Because metabolism (i.e. glycolysis) is the end result of many and diverse molecular     pathways, the effects of DCA might be positive in cancers with diverse molecular backgrounds.     DCA is also a very small molecule that readily crosses the blood brain barrier. Therefore we     hypothesize that DCA will be an effective and relative non-toxic potential therapy for     malignant gliomas.      We are conducting a phase II trial with 2 parallel arms: a) patients with newly diagnosed     malignant gliomas and b) patients with recurrent gliomas or gliomas that have failed standard     therapy (which includes surgery, radiotherapy and chemotherapy). All patients need to have a     histological diagnosis. DCA will be given orally and patients will be followed for a minimum     of 6 months. The tumor size will be followed by standard MRI or CT criteria and glucose     uptake (a direct effect of DCA on the tumor) will be measured by FDG-PET imaging. Several     clinical parameters and quality of life will be followed. Potential toxicity (particularly     peripheral neuropathy) will be closely followed and dose-de-escalation protocols are in place     in case of toxicity. In addition, escape protocols for the application of standard therapy     (when appropriate) are in place in patients with no evidence of response to DCA. In vitro     studies will be performed in the tissues obtained at the time of surgery (where appropriate)     and correlated prospectively with clinical data.      There is limited ability to accept patients outside of Alberta; this is in part because the     visit and testing schedule is intense, requiring residence in Edmonton for at least 6 months.   "
205420|NCT00540189|"     To determine the most cost effective way to treat children with perforated appendicitis we     will randomize all children presenting with perforated appendicitis to initial operation,     with in 24 hours of admission, or to initial antibiotics, with or without percutaneous     drainage, and subsequent interval appendectomy after 8 weeks. Our outcomes will include cost,     complications, length of stay, and quality of life measures.   "
205421|NCT00540202|"     We will test the hypothesis that there is a difference in effectiveness of oral quinine in     comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.   "
205422|NCT00540215|"     It is the study aim to investigate the effect of glp-2 on blood flow in humans. we wish to     study eventual changes in renal blood flow, carotic blood flow and cardiac out put.      GLP-2 will be administered subcutaneously, and the effect monitored by doppler ultra sound     scannings and cotinuesly measuring of cardiac out put and blood pressure.      The study will include 15 healhty volunteers, 10 wil receive 450 nmol GLP-2 and 5 will     receive 1 ml of isotonic saline (as baseline reference).   "
205423|NCT00540228|"     In order to find the formulation leading to a maximal increase of the immune response while     maintaining an acceptable safety profile, this study is designed to evaluate the     immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals'     influenza vaccine administered in adults aged 18-64 years.   "
205424|NCT00540241|"     The primary research objective of this observational study in pretreated patients with NSCLC     of Stage IIIa/b or Stage IV is to evaluate patients' Karnofsky Index (KI) after the second     cycle of second-line treatment with single agent pemetrexed in a real life setting, and to     evaluate factors potentially influencing performance status in terms of KI, i.e. frequency of     use of concomitant medications, in particular analgesics, folic acid, Vitamin B12,     antiemetics, and medications against diarrhea; as documented in patient diary (days of use     per week) and by the physicians.   "
205425|NCT00540254|"     The purpose of this study is to determine how best to manage the sleep problems of people     with Chronic Fatigue Syndrome. This study is being conducted to determine how improvements in     sleep affect other Chronic Fatigue symptoms including pain, fatigue, and mood as well as a     person's sense of general well-being.   "
205426|NCT00540267|"     People with chronic mental disorder such as schizophrenia and alcohol abuse are high risk     groups for developing osteoporosis.      To evaluate the prevalence of bone mineral density in men patients with schizophrenia with     alcohol abuse, the investigators will compare bone mineral density between patient with     schizophrenia with and without alcohol abuse.   "
205427|NCT00540280|"     Randomized Phase III trial of surgery alone or surgery plus preoperative     Gemcitabine-Cisplatin in clinical early stages of non-small cell lung cancer   "
205428|NCT00540293|"     To evaluate the percentage of Korean dyslipidemic subjects in the total group and each     cardiovascular risk group achieving LDL-C target as defined by NCEP ATP Ⅲ criteria at     starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.   "
205429|NCT00540306|"     The purpose of this study is to do determine the changes in physiological and optical     properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse     Optical Spectroscopy. The Researcher can determine 1) how large variations in breast tissue     components are 2) how predictable and repeatable these variations are 3) the effects of     endogenous hormones on breast tissue physiology.   "
205430|NCT00540319|"     Pregnancy is a critical time to address preventable behavioral risks that pose serious     threats to the health of both the mother and the developing fetus. We propose to conduct a     randomized, controlled trial to determine the extent to which the Health in Pregnancy (HIP)     program, a brief motivational intervention featuring a Video Doctor, provider cueing     sheets, and patient educational worksheets, can reduce pregnant women's cigarette smoking,     alcohol drinking, illicit drug use, and domestic violence risks compared with usual care.   "
205431|NCT00540332|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin     on the incidence of oral mucositis in subjects with locally advanced head and neck cancer     receiving postoperative radiotherapy.   "
205432|NCT00540345|"     The purposes of this study are:        1. To evaluate the efficacy and safety of low-dose versus standard-dose of ribavirin in          combination with peginterferon alfa-2a given for 16 weeks in hepatitis C virus (HCV)          genotype 2 infected, treatment-naïve chronic hepatitis C patients after achieving a          rapid virologic response (RVR,defined as seronegativity of HCV RNA at week 4 of          treatment).        2. To evaluate the efficacy and safety of 24-week versus 48-week regimen of peginterferon          alfa-2a plus standard-dose of ribavirin in HCV genotype 2 infected, treatment-naïve          chronic hepatitis C patients who have no RVR.   "
205433|NCT00540358|"     The purpose of this clinical trial was to determine whether combining iniparib (BSI-201) with     standard chemotherapy in estrogen receptor (ER)-negative, progesterone receptor     (PR)-negative, and human epidermal growth factor receptor 2 (HER2) negative metastatic breast     cancer patients improve clinical benefit compared to treatment with standard chemotherapy     alone.      Based on data generated by BiPar/Sanofi, it was concluded that iniparib does not possess     characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact     mechanism has not yet been fully elucidated, however based on experiments on tumor cells     performed in the laboratory, iniparib is a novel investigational anti-cancer agent that     induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in     the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging     modalities in tumor cell lines. Investigations into potential targets of iniparib and its     metabolites are ongoing.   "
205434|NCT00540371|"     The purpose of the study is to improve the efficacy of pulsed dye laser treatment of port     wine stain birthmarks. Involvement in the protocol will involve formal documentation of the     level of treatment pain, duration of post-treatment purpura and incidence of side effects. In     addition, measurements will be taken of blood substances that promote blood vessel     formation/regrowth and non-invasive reflectance measurements and photographs will be taken     before and after treatment.      The objective of this study is to document the degree of port wine stain lightening, the     incidence of side effects and the presence of angiogenic factors induced during treatment     with the pulsed dye laser in association with cooling agent. This information ultimately lead     to improved treatment.   "
205435|NCT00540384|"     The purpose of this study is to assess the safety of NESP administered by SC injection in     subjects with solid tumours and anaemia receiving multicycle chemotherapy.      Subjects in this study enter one of two schedules: Schedule 1 or Schedule 2. Schedule 1 is a     sequential dose escalation study which consists of Parts A and B. Part A is the initial     treatment phase, where the clinically effective dose (CED) of NESP administered every 3 weeks     will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label,     dose-maintenance phase that follows Part A.      Schedule 2 is a parallel dose-finding study and also consists of Parts A and B. Part A is the     initial treatment phase, where the CED of NESP administered every 4 weeks will be determined     after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance     phase that follows Part A.   "
205436|NCT00540397|"     To Elucidate and Confirm the Theory of XuSunShengJi in the Traditional Chinese Medicine     Etiological Pathogenesis of Liver Cirrhosis.   "
205437|NCT00540410|"     Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and     parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine,     based on the first malaria attack of each subject.      Secondary objectives:      For the first attack: To compare the two groups of treatment in terms of:        -  D14 efficacy        -  Parasitological and fever clearance        -  Clinical and biological tolerability        -  Evolution of gametocyte carriage        -  Cardiac tolerability (QTc)      For the repeated attacks: To compare the two groups of treatment in terms of:        -  D14 and D28 clinical and parasitological effectiveness (PCR adjusted)        -  Clinical and biological tolerability        -  Proportion of patients without fever at D3        -  Proportion of patients without parasite at D3        -  Compliance        -  Impact on anaemia      During the total follow-up of the cohort: To compare the two groups of treatment in term of:        -  Treatment incidence density        -  Impact of repeated treatment on clinical and biological safety        -  Impact of repeated treatment on hearing capacity   "
205438|NCT00540423|"     This is a Phase II/III multicenter study comprising of the double-blind, followed by     open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag     (SB-497115-GR) in chronic ITP patients   "
205439|NCT00540436|"     The primary objective of this study is to evaluate the effect of GSK1325760A on improvement     in exercise capacity in subjects with pulmonary arterial hypertension (PAH).      The secondary objectives of this study are to evaluate administration of GSK1325760A on:        -  The safety and tolerability        -  Improvement of PAH        -  The steady-state plasma pharmacokinetics of GSK1325760A   "
205440|NCT00540449|"     The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278     given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily,     when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir     disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV     drugs. The following evaluations will be done: antiviral activity, immunologic changes, and     viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and     PK/Pharmacodynamics, medical resource utilization and treatment adherence.   "
205441|NCT00540462|"     Although intensive medical treatment of diabetes has clearly been demonstrated to be     worthwhile, it has not been a total success in diabetes treatment for a variety of reasons     including lack of response to medication. Diabetes has been well demonstrated as a     co-morbidity illness of obesity patients. In observation, with exclusion stomach and duodenum     of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes     had a significant improved of sugar control. Base of this observation, we will try to find     out the role surgical intervention (gastric bypass & sleeve gastrectomy) in obese-related     diabetes.   "
205442|NCT00540475|"     The Pennsylvania Idiopathic Pulmonary Fibrosis State-wide Research Registry (PA-IPF) is a     cooperative project between five medical centers to coordinate a team of investigators. The     aim of this registry will be: 1) To assess the extent of lung fibrosis in the commonwealth of     Pennsylvania 2) To provide better access of patients with pulmonary fibrosis in all regions     of Pennsylvania to standard of care and diagnosis 3) To facilitate the translation of new     therapeutic interventions from the bench to the bedside.   "
205446|NCT00540527|"     The purpose of this study is to determine whether intra-arterial rt-PA within 6 hours from an     ischemic stroke onset, compared with intravenous infusion of the same drug within 3 hours,     increases the proportion of independent survivors at 3 months.   "
205447|NCT00540540|"     Approximately twelve percent of the women in the United States will develop breast cancer,     the most common form of cancer affecting women, with 183,000 new cases projected for 1995.     Despite the increasing incidence, the age-adjusted death rate from carcinoma has remained     relatively stable. Although the reason for this has not yet been demonstrated, this stability     may be a direct consequence of early detection and improved therapy. Screening mammography as     an early detection technique has been shown to reduce mortality by 23%. Mammographic     abnormalities that go on to biopsy show 24% being positive for malignancy with great     variability (6-75%). Breast biopsy is an expensive procedure with the risks of anesthesia and     surgery which may be obviated by more specific non-invasive testing.   "
205448|NCT00540553|"     This research study is the first administration of GSK971086 in humans. The purpose of this     study is to assess the safety and tolerability of GSK971086, as well as, how much GSK971086     is in your blood after different doses   "
205449|NCT00540566|"     This study is to compare the ability of optical biopsy. Research can use light enters the     skin, collected, analyzed by the computer, and a picture created for the pathologist to     conventional histologic examination compare with the pathologist looking at the piece of     tissue through a microscope makes the diagnosis.   "
205450|NCT00540579|"     Because the activity of CC-4047 addresses numerous mechanisms of carcinoma growth inhibition     - including, but not limited to anti-angiogenesis - CC-4047 has been selected for development     as part of induction chemotherapy regimens for solid tumors. This study in pancreatic cancer     is designed to determine the appropriate CC-4047 dose and regimen in combination with     gemcitabine.   "
205451|NCT00540592|"     In order to find the formulation leading to a maximal increase of the immune response while     maintaining an acceptable safety profile, this study is designed to evaluate the     immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals'     influenza vaccine administered in adults aged 65 years and older compared to Fluarix.   "
205452|NCT00540605|"     A new approach to HIV prevention currently being studied includes the use of topical     microbicides, substances that kill microbes. The purpose of this study is to determine the     levels of tenofovir, a microbicide in gel form, in HIV uninfected pregnant women who are     expecting to deliver by cesarean.   "
205453|NCT00540618|"     To compare disease activity, as measured by PASI score, of three MEDI-507 dosing     (injection)regimens vs. placebo.   "
205454|NCT00540631|"     Multicenter Immunotherapy House Dust Mite Allergoid   "
205455|NCT00540644|"     The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and     prednisone (RCP) in patients with newly diagnosed multiple myeloma.   "
205456|NCT00540657|"     The purpose of this study is to determine whether CCX282-B is effective in mitigating the     effects of gluten ingestion in patients with celiac disease   "
205457|NCT00540670|"     The purpose of this study is to assess the safety and tolerability of E5555 in Japanese     subjects with coronary artery disease.   "
205458|NCT00540683|"     The researcher can use Diffuse Optical spectroscopy technique that uses harmless levels of     near-infrared light to probe the concentrations and states of important physiological     molecules such as hemoglobin water and lipids in human muscle,.   "
205459|NCT00540696|"     The purpose of this study is to develop a functional capacity screening tool (FCST) that     estimates at baseline the functional capacity of anemic subjects with nonmyeloid malignancies     receiving multicycle chemotherapy.      Sites will be randomly assigned in 1:1 ratio to 1 of 2 different subject-reported functional     capacity questionnaires. The questionnaires will be used to develop the FCST. Subjects will     participate in the Modified Harvard Step Test (MHST) at required timepoints and receive     darbepoetin alfa once every 2 weeks for 15 weeks. All subjects will return for a follow-up     visit 2 weeks after the last dose of darbepoetin alfa.   "
205460|NCT00540709|"     Whether a once-daily basal injection of insulin glargine with mealtime injections of insulin     lispro achieves equivalent glycaemic control (HbA1c) to administration of insulin lispro by     continuous subcutaneous insulin infusion in Type 1 diabetic patients.   "
205461|NCT00540722|"     This phase II trial is studying how well gossypol works in treating patients with progressive     or recurrent glioblastoma multiforme. Gossypol may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
205462|NCT00540735|"     Unresectable type III or IV cholangiocarcinoma has a very bad prognosis; survival median     ranges between 6 and 9 months.      Survival depends on biliary drainage quality, obtained by plastic or metallic prothesis     setting up in one or several hepatic segments.      Radiotherapy and/or chemotherapy didn't prove yet their efficiency on survival. In France,     gemcitabin is recommended by the French Digestive Oncology Federation in metastatic tumours,     in monotherapy or associated with cisplatin or oxaliplatin (Gemox) for patients in good     general condition.      Photodynamic therapy has shown in 3 prospective studies - one randomized - with small patient     series, a significative efficiency on survival and quality of life of treated patients, in     comparison with historical series, or patients' groups whose biliary drainage was in most     cases unefficient.      A new randomized study, including patients whose biliary drainage is efficient and comparing     their becoming when they are treated by PDT in addition to current practice, or only by     current practice, seems to be justified.      The principal objective of this study is to evaluate the efficiency of PDT with Photofrin® on     patients with unresectable type III or IV cholangiocarcinoma.   "
205463|NCT00540748|"     This is a randomized, single-blind study using oxytocin 5U i.v. during surgical abortion in     one arm of the study, and no medication in the other arm of the study. Comparison is done     between the two groups measuring the following outcomes: pain, nausea and blood loss. The     investigators' hypothesis is that there will be no significant differences between the two     groups.   "
205570|NCT00527007|"     The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock     patients' outcome. The aim of this multicenter randomized controlled trial is to determine     whether external cooling might accelerate improvement in cardiovascular function.   "
205464|NCT00540761|"     Atherosclerosis, a condition in which fatty deposits of plaque build up along the inner walls     of arteries, is a condition that may increase the risk of having a heart attack. Previous     studies have shown that the presence of a specific kind of plaque, known as vulnerable     plaque, is often found in people who have had a heart attack. This study will use a new     imaging technique called optical frequency domain imaging (OFDI) to examine the presence of     vulnerable plaques in people with coronary artery disease.   "
205465|NCT00540774|"     Overall objective of this work is to identify optical properties of healthy, diseased,     dysplastic and malignant oral tissues, to compare these with conventional diagnostic     approaches such as standard of care clinical techniques as well as semi-quantitative     histo-pathological assessment and potential biomarkers in oral tissues and fluids to (1) gain     a better understanding of processes involved in oral pathology and (2) develop a combined     patient specific, non-invasive method for the detection, diagnosis and screening of oral     pathology. Thus our goal is to identify and evaluate microstructural, metabolic, vascular,     protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict     and map oral pathology, especially neoplasia.      We are recruiting patients with a wide range of oral conditions including plaque, dry mouth,     toothache, root canal treatments, gum disease, oral sores, dysplasia and cancer, autoimmune     conditions and others as well as healthy control subjects. We will use a range of     non-invasive imaging modalities to obtain information on the ways in which the oral health     status affects optical properties, and determine means of detecting and quantifying these     factors.. Imaging modalities to be utilized include:        1. Coherence and Doppler Tomography        2. Laser Speckle Imaging        3. Various forms of Spectroscopy        4. Fluorescence   "
205466|NCT00540787|"     The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic     drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation     patients.   "
205467|NCT00540800|"     Some chemotherapies, including docetaxel, are better tolerated and just as effective when     giving the dose weekly rather than on an every three week basis. The purpose of this study is     to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality     of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for     metastatic or locally advanced breast cancer.   "
205468|NCT00540813|"     The aim of the study is to investigate the feasibility of Paclitaxel-eluting PTCA-balloon     dilation (SeQuent Please) followed by bare metal stent (Coroflex ) deployment in the main     branch (reference diameter: ≥ 2.5 mm and ≤ 3.8 mm, reference diameter of side branch: ≥ 2.0     mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 20 mm) in the treatment of significant     (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native left     coronary artery as reflected by procedural success and to evaluate the preservation of vessel     patency.   "
205469|NCT00540826|"     The primary research objective of this observational study is to evaluate treatment     compliance over one year in children and adolescents who are newly initiated on medication     approved for the treatment of ADHD in a routine clinical setting. Compliance will be assessed     using the Pediatric Compliance Self-Rating (PCSR) Instrument. A patient will be considered as     compliant at a given visit, if the PCSR score is at least 5, corresponding to taking the     medication at least often.   "
205470|NCT00540839|"     A study to determine the effects of montelukast (MK-0476) on pediatric participants with     chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of     treatment, montelukast will provide at least the same level of asthma control as inhaled     fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of     treatment, daily administration of montelukast will be safe and well tolerated in children     aged 6 months to 5 years with chronic asthma.      This trial was stopped at a time before any participants had actually entered the trial.     Based on input from regulatory agencies, it is not necessary to conduct this study; a     separate ongoing study was sufficient for regulatory purposes.   "
205471|NCT00540852|"     Optimal management of patients with locally advanced breast cancer remains a complex     therapeutic problem. Newly diagnosed breast cancers in the United States with a higher     incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant     chemotherapy still remains controversial due to the difficulty of evaluating response to     therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant     chemotherapy.   "
205472|NCT00540865|"     This study will compare the effectiveness of case management combined with problem-solving     therapy (CM-PST) versus case management (CM) alone for assisting elderly people with     depression.   "
205473|NCT00540878|"     This study will examine the effects of formulation on the relative bioavailability of     SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a     single oral dose of each formulation, with five formulations of SB-751689 tested in total.     Blood samples will be taken up to 24 hours postdose after each dose administration. This     study will provide information for future possible formulation development of SB-751689 for     Phase III.   "
205474|NCT00540891|"     Primary: Evaluate the safety and onset of symptom relief using an acute I-PSS form (7 day     form).      Determine onset of urinary peak flow improvement after 7 days Secondary: Determine     improvement in Bother Score after 7 & 28 days; improvement in sexual function after 28 days;     assess one-month efficacy and safety   "
205475|NCT00540904|"     Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A     study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in     comparison with the same volume hydratation with sodium bicarbonate. The investigators will     try following the original protocol making 2 randomized groups of patients, with cancer     diagnosis, >18 years old, with a GFR <60 and >30 ml/min/1,73m2 by MDRD formula and/or     diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a     sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during     and 6 hours before the injection. The primary end point will be the rise of 25% or more in     creatinine or dialysis needed.   "
205587|NCT00527228|"     The present study is designed to assess the natural history in a one year pre-phase of the     trial and evaluate therapeutic efficacy and side effects of deflazacort in LGMD2B/MM patients     in a placebo-controlled trial. Furthermore, long-term development of the disease under     naturalistic conditions will be documented in a 2-year follow-up after the end of the     double-blind treatment phase.   "
205476|NCT00540917|"     Lasers are the treatment modality of choice for Port Wine Stain birthmarks.The epidermis is     not totally spared due to partial absorption of energy therein by melanin that presents an     optical barrier through which the light must pass to reach the underlying blood vessels.     Absorption of laser energy by melanin causes localized heating in the epidermis, which may,     if not controlled, produce permanent complications such as hypertrophic scarring or     dyspigmentation.   "
205477|NCT00540930|"     Uveal Melanoma is the most common primary intraocular malignancy in adulthood. Eye preserving     treatments can deliver equivalent life prognosis in the management of small and medium sized     uveal melanomas, as compared to enucleation. Plaque radiotherapy has emerged as the most     common eye-preserving treatment in the current management of uveal melanoma, but is     complicated by visual loss in approximately 70% of patients at 10 years follow-up. Strategies     for the prevention and early treatment of radiation retinopathy/maculopathy need to be     developed to improve visual outcomes following plaque treatment. Ranibizumab (Lucentis) is     the antigen binding fragment of a recombinant, humanized monoclonal antibody, which inhibits     the activity of vascular endothelial growth factor A, a mediator in the development of     choroidal neovascularization. Lucentis is commonly used in the eye for eye conditions such as     age related macular degeneration. This study will investigate the possible benefit of     Anti-VEGF therapy (Lucentis) in reducing the incidence of radiation complications following     plaque radiation for uveal melanoma.   "
205478|NCT00540943|"     Subjects will be entered into cohorts of 3 for the dose escalation phase so that the maximum     tolerated dose can be determined. 18 additional patients will be recruited once the maximum     tolerated dose (MTD) is determined for disease assessment.   "
205479|NCT00540956|"     RATIONALE: Studying natural killer cells in samples of blood from patients with cancer may     help doctors find out how these cells are effected by chemotherapy.      PURPOSE: This clinical trial is studying natural killer cells in older patients with acute     myeloid leukemia.   "
205480|NCT00540969|"     RATIONALE: Cryoablation kills cancer cells by freezing them. Radiation therapy uses     high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known     whether cryoablation is more effective than external-beam radiation therapy in treating     painful bone metastases.      PURPOSE: This randomized phase III clinical trial is studying cryoablation to see how well it     works compared with external-beam radiation therapy in treating patients with painful bone     metastases.   "
205481|NCT00540982|"     RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This pilot trial is studying the side effects and best dose of vinorelbine in     treating patients with advanced solid tumors that have not responded to treatment and liver     dysfunction.   "
205482|NCT00540995|"     RATIONALE: Giving chemotherapy drugs, such as busulfan and etoposide, and intensity-modulated     radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells.     It also helps stop the patient's immune system from rejecting the donor's stem cells. When     the healthy stem cells from a donor are infused into the patient they may help the patient's     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving intensity-modulated radiation therapy together with busulfan and etoposide before a     transplant may stop this from happening.      PURPOSE: This phase I/II trial is studying the side effects and best dose of     intensity-modulated radiation therapy when given together with busulfan and etoposide     followed by a donor stem cell transplant and to see how well it works in treating patients     with advanced myeloid cancer.   "
205483|NCT00541008|"     RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib works as first-line therapy in     treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.   "
205484|NCT00541021|"     RATIONALE: Drugs used in chemotherapy such as gemcitabine, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. It is not yet known whether giving     gemcitabine together with sorafenib is more effective than giving gemcitabine alone in     treating pancreatic cancer.      PURPOSE: This randomized phase III trial is studying giving gemcitabine together with     sorafenib to see how well it works compared with giving gemcitabine alone in treating     patients with locally advanced or metastatic pancreatic cancer.   "
205485|NCT00541034|"     RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Giving pentostatin     together with cyclophosphamide and rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects and how well giving pentostatin     together with cyclophosphamide and rituximab works in treating patients with previously     untreated chronic lymphocytic leukemia.   "
205486|NCT00541047|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause     the growth of prostate cancer cells. Androgen deprivation therapy, such as goserelin,     leuprolide, or bicalutamide, may lessen the amount of androgens made by the body. Giving     radiation therapy together with androgen deprivation therapy may kill more prostate cancer     cells.      PURPOSE: This randomized phase III trial is studying how well giving radiation therapy     together with androgen deprivation therapy works in treating patients who have undergone     surgery for prostate cancer.   "
205487|NCT00541060|"     Alteration of the post- eruptive enamel microstructure due to a mutation of a gene coding for     a matrix protein could increase the susceptibility of the enamel to caries after tooth     eruption. To identify in young patients with severe caries incidence, the occurrence of     mutations in several candidate genes which result in an alteration of the enamel     microstructure that could explain the high caries susceptibility of the patient.   "
205488|NCT00541073|"     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving pemetrexed together with cisplatin and vitamin B12 may kill more tumor     cells.      PURPOSE: This phase II clinical trial is studying how well giving pemetrexed together with     cisplatin and vitamin B12 works in treating patients with mesothelioma of the chest that     cannot be removed by surgery.   "
205489|NCT00541086|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by blocking use of estrogen by the tumor cells.     Anastrozole, letrozole, and exemestane may fight breast cancer by lowering the amount of     estrogen the body makes. It is not yet known whether giving tamoxifen followed by     anastrozole, letrozole, or exemestane is more effective than giving anastrozole, letrozole,     or exemestane alone in treating breast cancer.      PURPOSE: This randomized phase III trial is studying giving tamoxifen followed by either     anastrozole, letrozole, or exemestane to see how well it works compared to anastrozole,     letrozole, or exemestane alone in treating postmenopausal women with hormone-responsive     invasive breast cancer that has been completely removed by surgery.   "
205490|NCT00541099|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such     as docetaxel, also work in different ways to kill tumor cells or stop them from growing.     Giving bevacizumab together with docetaxel may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel     works in treating older patients with stage III or stage IV non-small cell lung cancer.   "
205491|NCT00541112|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy     together with combination chemotherapy and cetuximab before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy     and cetuximab after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II clinical trial is studying how well giving radiation therapy together     with chemotherapy and cetuximab followed by surgery, chemotherapy, and cetuximab works in     treating patients with locally advanced or metastatic rectal cancer that can be removed by     surgery.   "
205492|NCT00541125|"     RATIONALE: G-CSF may prevent or control neutropenia caused by first-line therapy in patients     with metastatic colorectal cancer.      PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia     during first-line treatment with chemotherapy and bevacizumab in patients with metastatic     colorectal cancer.   "
205493|NCT00541138|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Tamoxifen may help carboplatin work better by making tumor cells more sensitive to     the drug.      PURPOSE: This phase II trial is studying the side effects of giving carboplatin and topotecan     together with tamoxifen and to see how well it works in treating patients with central     nervous system metastases or recurrent brain or spinal cord tumors.   "
205494|NCT00541151|"     Multi-center, prospective, single arm study. Qualify patients will receive treatment for     stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term     evaluation of effectiveness and safety associated with AMS sling systems.   "
205495|NCT00541164|"     The object of this research is to test the effectiveness of Coenzyme Q10 (CoQ10) on symptoms     of weakness, fatigue, and pain in persons with Charcot-Marie-Tooth disease (CMT).In this     study we also intend to examine the impact of daily supplementation on overall quality of     life.We are also interested in identifying any differences in serum ratios of CoQ10 in the     oxidized and reduced forms.   "
205496|NCT00541177|"     The purpose of this study is to test the hypothesis that myopia can be prevented by using a     low concentration of atropine eyedrops once a week.   "
205497|NCT00541190|"     The objective of this overall project is to develop a new aerosol-based technique for     quantifying liquid absorption in the airways of subjects with cystic fibrosis(CF) that can be     used to help develop new therapies. In CF, mutations in the CF gene result in dysfunction of     the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) ion channel on the cells that     line the airway epithelium, causing improper fluxes of ions such as sodium, chloride, and     bicarbonate. The so called low volume hypothesis of CF pathogenesis contends that abnormal     absorption of ions from the airways causes excessive absorption of liquid, resulting in an     airway surface liquid layer that is dehydrated and difficult to clear. Here we are measuring     the absorption rate of a radiolabeled small molecule (DTPA) from the lungs of cystic fibrosis     patients and healthy controls. We hypothesize that the molecule will absorb more quickly in     cystic fibrosis patients. Further studies will be performed to determine if DTPA absorption     is related to liquid absorption in the airways.   "
205498|NCT00541203|"     Coronary CT angiography (CCTA) offers great promise as a risk stratification tool in patients     with suspected CAD. It has been demonstrated in a multitude of accuracy studies to have a     negative predictive value averaging over 95%. This leads to the hypothesis that a negative     CCTA may preclude the need for invasive testing. The purpose of this randomized controlled     study is to prospectively evaluate the role of CCTA on the management of patients with     inconclusive or indeterminate stress test results.CCTA is able to provide not only     information on presence and extent of coronary artery calcification, but detailed coronary     anatomy as well.      SPECIFIC AIM # 1: To evaluate the diagnostic and prognostic performance of CCTA in patients     with equivocal / intermediate stress test results as compared to conventional invasive     coronary angiography.      SPECIFIC AIM # 2: To evaluate the utility of CCTA in prediction of major adverse cardiac     events (MACE) compared to invasive coronary angiography at 30 days, 1 year, 3 years and 5     years.   "
205499|NCT00541216|"     Previous research has demonstrated possible efficacy of Ephedrine in the treatment of     congenital myasthenia caused by end-plate acetylcholinesterase deficiency.      The aim of the current study is to test the hypothesis that Ephedrine may be beneficial to     these patients.      To test this hypothesis we will perform a double blind, placebo-controlled, crossover study     clinical efficacy and safety study.      Drug naïve patients who agree to participate will be randomized to two groups. Each group     will be treated in a blinded manner for 5 weeks with either placebo or Ephedrine HCl in an     escalating dose up to 100 mg per day divided in two doses. After five weeks the groups will     cross over and continue treatment or placebo for a further five weeks.      Evaluations of strength and fatiguability will be done at baseline, at the end of each five     week period and after a further two weeks.      Safety will be assessed weekly by the investigators using interview and physical examination.      Outcome measures will include Barthel index, Quality of life questionnaire, Timed up and go,     spirometry, timed elevation of limbs, and force measurements.      All patients will report to the clinic as per study schedule (See Appendix A). Specifically,     the 12 clinic visits will include: baseline (1), safety and efficacy assessments(10) and     closeout (1).   "
205500|NCT00541229|"     A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg     in patients with type 2 diabetes.   "
205501|NCT00541242|"     The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients     with glaucoma or ocular hypertension   "
205502|NCT00541255|"     Asthma is a common disease that is often diagnosed in childhood. In some teenagers, asthma     symptoms disappear and treatment can be stopped; however, for some of these people, asthma     symptoms return in adulthood. This study will examine data collected over the lifetime of     18-year olds to identify factors that may increase a person's chance of having recurrent     asthma as an adult.   "
205503|NCT00541268|"     Primary objective: The primary objective of this study is to determine the efficacy of ICD     therapy compared with control on the endpoint of death from any cause.      Secondary objective: The secondary objectives of the study are to determine if ICD therapy     reduces sudden death.      Study design: Randomized, unblinded, controlled, parallel two group trial.      Primary endpoint: Time to death from any cause.      Sample size: In total, 1000 patients with 500 receiving ICD and 500 patients constituting the     control group.      Summary of Subject Eligibility Criteria: Patients with clinical heart failure, left     ventricular ejection fraction (LVEF) ≤ 35%, non-ischemic etiology and NT-proBNP above 200     pg/ml. Patients in NYHA class IV will only be randomised if also fulfilling criteria for a     biventricular pacemaker.      Control group: Patients receiving standard therapy for heart failure including     ACE-inhibitor/Angiotensin-Receptor-Blocker and Betablocker unless not tolerated. Aldosterone     antagonism is optional.      Study Duration: The study comprises a screening period of up to 2 years, followed by a     treatment phase of a minimum of 36 months.      Randomisation: After fulfilling all eligibility criteria, subjects will be randomized 1:1 to     receive ICD implantation or continue usual control. Randomisation will be stratified     according to treatment with a biventricular pacemaker.      Treatment: After randomisation patients allocated to ICD treatment should receive this as     fast as possible and preferably within 2 weeks (latest 4 weeks). The ICD will be programmed     with anti-tachycardia pacing and shock therapy.      Assessments: Deaths and hospitalisations for heart failure, stroke or arrhythmias will be     recorded throughout the study duration.      Statistical Considerations: Median lifetime in the control group is expected to be 5 years. A     p-value of 5% (2-sided) is required for significance together with a power of at least 80%.     With a relative risk reduction of 25% a sample size of 812 patients in total is required. In     order to allow for cross-over a sample size of 1000 is planned.      Primary Endpoint Analysis: The principal analysis for the primary endpoint (time to death     from any cause) will employ the intent-to-treat principle and use a survival analysis.      Secondary Endpoint Analysis: All time-to-event secondary endpoints will be analyzed similarly     to the primary endpoint.   "
205504|NCT00541281|"     we propose to randomize patients with hormone resistant prostate cancer between     docetaxel/estramustine/prednisone and docetaxel/prednisone in a phase II study. The principal     endpoint will be the efficacy in term of PSA response.   "
205505|NCT00541294|"     Background: The TB and HIV epidemics are closely linked in developing countries, where     450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children     and is reversing gains made in child survival.      The traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting TB     infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker,     more accurate way to diagnose TB infection. Such diagnostic testing may directly guide     clinical management and preventive strategies in immune-suppressed HIV-infected children, who     are at high risk of becoming TB diseased following infection. Data regarding the usefulness     of these tests in children is currently limited.      Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB diagnostic     testing can accurately identify children with TB infection. In a community with high rates of     TB and HIV infection, the following specific aims will be investigated in HIV-infected and     uninfected children:        1. assess the agreement between the TST and blood-based diagnostic testing,        2. compare the performance of the TST and blood-based diagnostic testing to a standardized          history of TB exposure,        3. measure the impact of age, nutritional and immune status on children's response to          blood-based testing,        4. describe factors that might modify children's response to testing over time, and 5)          examine the effect of environmental exposures and previous vaccination on the TST,          blood-based testing and other measures of immune responses to TB.      Potential Impact: The benefits of an accurate, rapid diagnostic test of TB infection in     children include 1) timely institution of treatment for TB infection to prevent severe     disease and mortality, and 2) preclusion of over diagnosis and treatment. Treatment of     childhood TB infection also prevents future contagious adult disease, thus decreasing     community transmission. Blood-based diagnostic testing may also be able to identify children     that are more likely to become ill following TB infection. Therefore, blood-based diagnostic     testing has great potential to improve TB control and the health of HIV-infected and     uninfected children, their households and communities.   "
205506|NCT00541307|"     The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin     Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device     patency at 12 months is the primary endpoint.   "
205507|NCT00541320|"     This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of     VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s)     and dose regimen of GW813893 for future investigation.   "
205508|NCT00541333|"     The purpose of the project is to investigate in eyes with dry AMD, the efficacy and safety as     preventive therapy of the immunomodulatory substance named copaxone which had been proven as     safe and effective agent for a neurodegenerative disease, in arresting the progression as     well as the conversion of dry AMD to wet AMD. The hypothesis that the immunomodulatory agent     copaxone proven for a neurodegenerative disease may work in the eye is revolutionary and may     open a new avenue of preventive treatment for the disease which is the major cause of legal     blindness in the industrial world   "
205509|NCT00541346|"     This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system)     for the treatment of attention and behavioral symptoms in children with Autism Spectrum     Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total     of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism     spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal     route of administration in this population will also be assessed.      The researchers hypothesize that Daytrana is a safe and effective medication for children     with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and     impulsivity.   "
224211|NCT00780130|"     The purpose of this investigation is to determine the relationship of core stability to core     proprioception   "
205510|NCT00541359|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving bortezomib together     with topotecan hydrochloride may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan     hydrochloride when given together with bortezomib in treating patients with advanced solid     tumors.   "
205511|NCT00541372|"     For the administration of insulin, different needles are available with a length from 5 to     12.7mm. Insulin injections with a needle of 8 mm is injected in a lifted skinfold, a 5 mm     needle can by used without lifting a skinfold (1). In the Netherlands obese people (BMI ≥ 30)     are usually advised to use an 8mm or even longer needle (1). Increased BMI and the thickness     of the subcutaneous tissue slow insulin absorption (2, 3, 4), possibly related to reduced     subcutaneous blood flow. Furthermore, the capillaries are located just under the skin and     between the fat and muscle layer. This could possibly determine the absorbing speed (2). It     is not know if the administration of insulin with a 5mm needle by obese people has a     different influence on the HbA1c compared to longer needles. The hypothesis of this study is     that for the purpose of insulin injections, a 5 mm needle can be used without negative     effects on metabolic parameters in patients with Diabetes Mellitus (DM) and a Body Mass Index     (BMI) ≥ 30.   "
205512|NCT00541385|"     -  The primary objective of this clinical study is to demonstrate the efficacy of the fixed          combination of pyronaridine artesunate granule formulation (60:20 mg; paediatric          PYRAMAX®) by showing a PCR-corrected adequate clinical and parasitological cure rate of          more than 90%.        -  Treatment success or failures will be classified according to WHO Guidelines 2005   "
205513|NCT00541398|"     The primary purpose of the study is to investigate whether an intensive educational     intervention can reduce the use of antipsychotic polypharmacy. It is hypothesised that the     use of antipsychotic polypharmacy is, in some degree, dependent on non-patient related     factors.   "
205514|NCT00541411|"     Phase II Pilot Study of Vincristine, Adriamycin, Actinomycin D, Ifosfamide combination     chemotherapy in Ewing's Sarcoma   "
205515|NCT00541424|"     The goal of this clinical research study is to learn if positron emission tomography     (PET)/computed tomography (CT) scanning can be used to detect mantle cell lymphoma in the     colon. Researchers want to learn if PET/CT scanning can produce good-quality images and/or     find the exact locations of lymphoma in the body.      Primary Objective is to determine if combined CT colonography and full body PET scan is     technically feasible and can produce diagnostic scans as well as accurate anatomic     coordination for detection of mantle cell lymphoma involvement of the colon.   "
205516|NCT00541437|"     To evaluate the efficacy and safety of type 2 diabetes patients switched from sulfonylurea     co-administered with metformin to glyburide/metformin combination tablet. It is expected that     safety and efficacy of GlucoMet® is not inferior to co-administration of sulfonylurea and     metformin.   "
205517|NCT00541450|"     The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A     in comparison to a commonly used medication in patients with type 2 diabetes.   "
205518|NCT00541463|"     A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two     nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients     who have not responded to or are intolerant to a non-nucleoside reverse transcriptase     inhibitor (NNRTI) containing treatment.   "
205519|NCT00541476|"     The purpose of this study is to obtain more data about efficacy and safety of the study drug     Lyrica.   "
205520|NCT00541489|"     To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of     signs and symptoms of Osteoarthritis.   "
205521|NCT00541502|"     This is a 24-week, observational, prospective study to evaluate the effectiveness of     improving cognitive function of aripiprazole in treating adolescents and young adults with     psychotic disorder in Taiwan. Approximately 120 qualified patients who have clinical     diagnosis of DSM-IV of psychotic symptom (e.g. schizophrenia or other psychotic disorders     such as schizophreniform disorder, schizoaffective disorder, delusional disorder, shared     psychotic disorder, bipolar disorder with psychotic feature or psychotic disorder not     otherwise specified.) will be recruited to achieve at least 100 evaluable subjects. After     signing the informed consent form, the demographics, medical history and concomitant     medication will be recorded. Besides, physical examination, vital sign, BMI, DSM-IV     multiaxial examination, CGI-S and menstrual history will be conducted. Laboratory tests and     pregnancy test will be optionally conducted. After evaluating all variables obtained, the     eligible patients will be enrolled into study. Patients who fulfill the inclusion / exclusion     criteria will be performed the CPT, WCST, BPRS and WHOQOL. Afterwards, patients will be given     their first medication at this visit (5 mg ~ 30 mg daily by subject). Besides, the switching     period is maximum 8 weeks and is depended upon the clinical judgment of investigator.     Efficacy will be evaluated by the change from baseline in Continuous Performance Test (CPT),     Wisconsin Card Sorting Test (WCST), Clinical Global Impression Scale (CGI), Brief Psychiatric     Rating Scale (BPRS) and The World Health Organization Quality of Life questionnaire (WHOQOL).     Safety will be evaluated by the frequency of adverse events, abnormal laboratory results,     physical examination, vital sign, BMI and menstrual history for female subgroup analysis.   "
205533|NCT00541671|"     We are doing this study to find out if extra medicine is needed to avoid the chance of nausea     sometimes linked to narcotic pain medicine (for example, morphine, dilaudid, fentanyl). Some     doctors always give medicine to prevent the possible side effect of nausea, while others do     not. We are looking to see if this extra medicine is helpful in preventing nausea. The goal     is to screen all patients with pain and enroll enough subjects to reach our goal of 164     evaluable study participants.   "
205534|NCT00541684|"     The study will look at the effects of losartan or atenolol on frequency of sexual intercourse     in subjects with newly diagnosed mild to moderate hypertension.   "
205535|NCT00541697|"     A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus     Atorvastatin in lowering LDL-C levels.   "
205588|NCT00527241|"     This trial will test the impact of a culturally tailored and theory driven primary intimate     partner violence prevention intervention with Spanish speaking Latino men.   "
205522|NCT00541515|"     An open interventional data collection study in order to build a database to close the loop     between glucose sensor and insulin pump.      background: The ultimate goal in diabetes treatment is to develop an autonomous insulin     delivery system (artificial pancreas) capable of continuous glucose sensing, thereby     mimicking the physiologic function of the islet beta cells and freeing the patient from the     need for constant calculations of daily insulin and carbohydrates. Several prototypes of     closed-loop system have been developed in recent years, based on different types of control     algorithms, to establish the connection between the sensor and the insulin pump. Current     research in the formulation of this type of subcutaneous closed-loop system still faces major     challenges, therefore, there is a need for further study and evaluation.      Objectives:        1. To evaluate the lag time of the effect of subcutaneous insulin infusion on blood glucose          levels by using continuous glucose sensor        2. To measure the insulin sensitivity as expressed by changes in blood glucose levels after          s.c insulin infusion .        3. To evaluate real time sensor calibration algorithms based on the measured lag times        4. Collecting clinical data in order to develop and evaluate mathematical models which will          serve a base to simulators.        5. Developing and accessing advanced learning and control algorithms as a step towards          developing an artificial pancreas   "
205523|NCT00541541|"     In this study, the investigators sought to determine whether a stimulation of the phrenic     nerve affects heart function. Heart function is assessed by acoustic cardiography.   "
205524|NCT00541554|"     This is a prospective, open-label study to evaluate the efficacy and safety in reducing     antipsychotic-induced hyperprolactinemia, weight gain, and dyslipidemia by aripiprazole.     Approximate 60 patients will be recruited to achieve at least 40 evaluable patients.   "
205525|NCT00541567|"     This is a placebo-controlled, randomized, double-blind, parallel arm, multicenter,     dose-ranging phase IIb trial to assess glycemic and weight loss efficacy and safety of     BMS-646256 in overweight and obese patients with type 2 diabetes who have been treated with     diet and exercise only or with half-maximal or greater metformin (≥1500mg/day) or     sulfonylurea monotherapy (stable dose for at least three months), but who remained     inadequately controlled (HbA1c >7% and HbA1c<10%).   "
205526|NCT00541580|"     Triplane and Juvenile Tillaux fractures of the ankle are well known in adolescent pediatric     population. It is widely accepted, that optimal treatment for displaced fractures is close or     open reduction and fixation with screws under general anesthesia and under intraoperative     fluoroscopy control. Usually a small degree of displacement (up to 2mm) is expected to be     healed without any sequences. Until now, no evidence of ankle function and pain after     skeletal maturity or long follow-up was published. More than that, no comparative study     between operative and no operative treatment of mild and borderline displaced fractures were     published.      The purpose of this study is to evaluate functional and radiographic results of operatively     and conservatively treated patients after they reach skeletal maturity.   "
205527|NCT00541593|"     Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of     investigational surgery which uses the endoscope as the primary operative tool. The insertion     sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra.     Multidisciplinary teams consist of surgeons and gastroenterologists who are collaborating to     develop safe and effective surgical techniques via the natural orifice route in order to     avoid surgical incisions. Pancreatic pseudocysts are cavities that form typically in the     lesser sac following an episode of acute pancreatitis, that may be able to be drained by a     variety of techniques, including endoscopically. Chronic pseudocysts often require surgical     drainage into the stomach. The medical device company known as Power Medical Interventions     has a computer-powered surgical stapler which rests on a flexible shaft. Following the     insertion of the endoscope, the powered stapler will be passed alongside the endoscope to     help the surgeon and gastroenterologist (working as a team) to see where to properly place     the stapler. Once the stapler is in position, one jaw of the stapler will be placed into the     pseudocyst, and the other jaw will be left in the stomach. The stapler will then be closed     and fired, creating a permanent connection between the two hollow spaces and allow the     contents of the pseudocyst to drain naturally out into the stomach and intestines. Utilizing     this technique, a surgical incision is avoided.      Hypothesis: Patients who undergo the Natural Orifice Translumenal Endoscopic Surgery for     treatment of their pancreatic pseudocyst will experience effective treatment with less     discomfort and with quicker recovery than standard surgical techniques.   "
205528|NCT00541606|"     The purpose of this study is to demonstrate that pharmacists working collaboratively with     physicians and other providers in an ambulatory care setting can improve glucose, blood     pressure, and lipid control, as well as improve quality of life, adherence to screening and     general preventative measures.   "
205529|NCT00541619|"     The primary objective of the study is whether subjects with hypertension and proteinuria     display increased sympathetic nerve activity compared to hypertensive subjects without     proteinuria and normotensive controls.   "
205530|NCT00541632|"     The purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA     test system to traditional culture methods in detecting the presence of Methicillin Resistant     Staphylococcus aureus (MRSA) directly from nasal samples.   "
205531|NCT00541645|"     Transient osteoporosis of pregnancy (TOoP) is uncommonly encountered in orthopedic and     obstetric practice, with most reports consisting of single cases.      This rare condition consists of significant osteoporosis affecting the hips and spine,     causing significant morbidity, and putting young female patients at risk for vertebral and     femoral neck fractures.      The pathogenesis of transient osteoporosis of pregnancy is unknown, with various theories as     to its etiology.      Recently, a number of reports have described elevated levels of PTHrP in patients with     transient osteoporosis in pregnancy and of the postpartum period Our goal in this study is to     assess the role of PTHrP in transient osteoporosis of pregnancy   "
205532|NCT00541658|"     The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing     regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.   "
205565|NCT00526942|"     The primary objective of this study is to evaluate the learnability of a 3 week, 40 minutes     per day, 5 day per week, computer-based visual training exercise by healthy mature     individuals undergoing normal aging.   "
205536|NCT00541710|"     The purpose of this study is to determine whether the phytoestrogen genistein is effective in     improving bone condition in pre-menopausal and post-menopausal women suffering for     osteopenia. Since, during the study the investigators realized that at least 70% of     post-menopausal recruited women suffered for metabolic syndrome (MS), we have added only in     these women, as secondary outcome measures, the evaluation of markers of cardiovascular risk.   "
205537|NCT00541723|"     To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to     placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile     and to compare two different application schemes of Xeomin. Each subject will be treated on     the right and left eye area, using the same dose but different application schemes (i.e. 3 or     4 injection sites).   "
205538|NCT00541736|"     The aim of the present study is to explore the importance of migraine genes on the     headache/migraine responses after GTN in FHM-patients and healthy volunteers.   "
205539|NCT00541749|"     This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of     single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in     adults with Systemic Lupus Erythematosus.   "
205540|NCT00541762|"     Context: Cholecystokinin (CCK) and neurotensin are stimulated during meal intake by the     presence of fat in the small intestine. The sequence of events suggests that fat hydrolysis     is crucial for triggering the release.      Objectives: The aim of this study was therefore to investigate whether CCK mediated the     effect of intraduodenal (ID) fat on neurotensin secretion via CCK-1 receptors.   "
205541|NCT00541775|"     The purpose of this study is to test the safety and effectiveness of sitagliptin in patients     with type 2 diabetes.   "
205542|NCT00541788|"     The purpose of this clinical phase I study is to measure the efficacy and side effects of     Common Sage in the treatment of hot flashes in 10 patients with prostate cancer who receive     androgen deprivation (AD) (exclusively or as part of a multimodality treatment) for a period     of minimum 6 months. Concomitant use of a non-steroidal anti-androgen during the first month     of the AD is permitted to prevent the flair-up phenomenon. However, the inclusion of patients     in the study will only start at least 2 weeks after the cessation of the anti-androgen. This     is done to exclude a possible influence of the anti-androgen on the severity and frequency of     hot flashes.      Once the informed consent is signed, the patient receives the study diary to note the daily     frequency and severity of hot flashes and their effect on daily quality of life. The severity     of the hot flashes is measured by the Moyad scoring scale. The effect on daily quality of     life is measured using the Hot Flash Related Daily Interference Scale (HFRDIS). The patient     will be instructed in detail how to use the diary.      After week 1, the patient returns the diary to the responsible physician. In return the     patient receives the study medication (Common Sage, product) and a diary for the next week     (=week 2). This procedure will be repeated until the end of the observation period (2 months     after enrollment in the study). The common Sage will be provided in tablets. The suggested     dose of Common Sage is 3 tablets a day (morning - noon - evening).      To be sure that the effect of Common Sage is NOT due to an inhibition of the effect of the     LHRH analogue, the related hormones (testosterone, FSH, LH, free testosterone and SHBG) will     be tested at three fixed moments: day of study enrollment, 1 month after study enrollment and     at the end of the study. In order to check the level of hemoglobin and cholesterol, every 2     weeks a blood count will be performed. It has been shown that LHRH analogues can induce     anemia and hypercholesterolemia. The investigators want to measure a possible effect of     Common Sage on both.      There are no known side-effects of the use of Common Sage. All symptoms that could be related     to the use of Common Sage will be recorded in detail. Therefore, a clinical examination     including blood pressure registration will be performed by the responsible physician on a     weekly base.   "
205543|NCT00541801|"     In this study, the investigators sought to determine whether an acoustic cardiographic     assessment of heart function is equivalent to Doppler-echocardiography in patients who are     treated with cardio-toxic cytostatic agents.   "
205544|NCT00541814|"     The purpose of this trial is to ascertain whether the withdrawal of calcineurin inhibitors     (CNI) will lead to less kidney transplant damage when compared with minimisation. The     investigators will assess this by comparing the degree of damage on kidney biopsies taken     before and after minimisation/withdrawal of CNI.   "
205545|NCT00541827|"     The primary aim of the study is to demonstrate that mitochondrial dysfunction occurs in both     skeletal muscle and circulating platelets of severely septic and septic shock ICU-admitted     patients. Secondary aims are to clarify the pathogenesis and the clinical relevance of     mitochondrial damage during sepsis.   "
205546|NCT00541840|"     Soft tissue sarcomas (STS) are an uncommon group of malignant tumors of mesenchymal origin.     For most advanced STS types, chemotherapy is currently the only available treatment.     Unfortunately, a very limited number of useful drugs are active against this disease.     Doxorubicin is widely considered the standard first-line treatment. Ifosfamide has also a     well-established activity (1,2) and is often administered either associated with Doxorubicin     or alone as a second-line chemotherapy treatment. Other drugs such as DTIC, Gemcitabine and     Temozolomide showed modest activity as a second-line agents (3,4). Thus, there is a necessity     to identify new agents with activity to improve therapy for patients with advanced STS. In     some studies, most STS showed VEGF expression, and elevated serum VEGF levels were found to     correlate with higher histologic tumor grade (5,6). Additionally, inhibition of VEGFR was     associated with tumor activity in preclinical models of sarcoma (7,8). For these reasons,     inhibition of VEGFR seems to be a reasonable approach to explore in the treatment of STS.     Sorafenib (BAY 43-9006) is an orally available, small molecule multi-kinase inhibitor of     VEGFR, PDGFR and RAF with demonstrated activity in the treatment of renal cell cancer (9).     Preclinical studies suggest that the combination of Sorafenib with cytotoxic agents results     in additive anti-tumor activity (10), initiating justification for combination studies. A     recent trial, however, reported an unexpected incidence of cardiac toxicity in patients with     STS treated with Bevacizumab, a monoclonal antibody that binds VEGF, in combination with     Doxorubicin (11). This finding suggest that the possibility of potentiation of the     cardiotoxicity of Doxorubicin when inhibiting the VEGF pathway cannot be ruled out. The     association of Sorafenib with Ifosfamide, the other established active agent against STS,     could improve the efficacy of single-agent Ifosfamide minimizing the risk of cardiac toxicity     .   "
205547|NCT00541853|"     This study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment     of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin     receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal     diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood     pressure is not normalized by ARB alone, CCB is selected additionally. Recent research     suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is     not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This     study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is     not controlled under 130/85 mmHg by Candesartan (ARB) alone.   "
205548|NCT00541866|"     This study will evaluate the safety and tolerability of voreloxin injection in combination     with cytarabine in patients with relapsed or refractory acute myeloid leukemia.   "
205566|NCT00526955|"     To investigate the effect of duration of Applied Kinesiology manual muscle testing on     strong versus weak result of the test.   "
205567|NCT00526968|"     The purpose of this study is to investigate the neurophysiological changes following single     doses of EVT 101 using fMRI during rest and during cognitive tasks in young healthy male     subjects.   "
224898|NCT00789360|"     The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato     Loxapine within a day.   "
205549|NCT00541879|"     Type 2 diabetes and obesity in children continue to increase at alarming rates with     devastating results. However, both these metabolic diseases are largely preventable through     adoption of a healthy lifestyle, an understanding of what happens to food in the body, energy     balance and some simple aspects of glucose regulation. Can elementary school children be     taught the knowledge and skills necessary to prevent type 2 diabetes and obesity? Children     need to learn this essential knowledge and practice these important health behavior skills.     Elementary school may be an ideal place to master this subject that is a direct and logical     extension of current health curricula including nutrition and physical activity blended with     science and math.   "
205550|NCT00541892|"     The purpose of this study is to determine if a new medium with no human serum albumine added     is as good as the media conventionally used for IVF/ICSI.   "
205551|NCT00541905|"     The aim of this study is to confirm efficacy and safety of NT 201 (Xeomin®, also known as     IncobotulinumtoxinA) after one injection session and to determine the efficacy and safety     profile and the duration of treatment effect of NT 201 in long-term treatment with repeated     injection sessions.   "
205552|NCT00526760|"     Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who     require more than 24 hours sedation.   "
205553|NCT00526773|"     To test the effectiveness of a motivational intervention compared with standard patient     education in improving economic and clinical outcomes in patients enrolled in an existing     heart failure (HF) disease management program.   "
205554|NCT00526786|"     The purpose of this study is to evaluate the safety and effectiveness of the CryoSpray     Ablation System to treat esophageal low grade dysplasia (LGD) or high grade dysplasia (HGD)     within Barrett's Esophagus (BE).   "
205555|NCT00526799|"     This multi-institutional phase I/II clinical trial will test the tolerability and efficacy of     the combination sorafenib and topotecan in patients with recurrent ovarian cancer, which is     platinum-resistant (recurrence within 6 months from completing platinum based therapy) or     refractory (progressive disease during platinum based therapy).   "
205556|NCT00526812|"     This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in     recurrent high-grade gliomas.   "
205557|NCT00526838|"     The purpose of this study is to assess the safety and tolerability of the multi-targeted     protein kinase inhibitor XL228 (active against IGF1R, Src, FGFR, and BCR-Abl) administered as     a once- or twice-weekly 1-hour intravenous infusion in subjects with advanced malignancies.   "
205558|NCT00526851|"     RATIONALE: Learning about oral cancer screening practices, knowledge, and opinions of Ohio     nursing home dentists may help the study of oral cancer in the future.      PURPOSE: This clinical trial is studying oral cancer screening among nursing home dentists in     Ohio.   "
205559|NCT00526864|"     Total 7 institutions will be recruited i.e. Clinical Infectious Disease Research Unit     Department of Clinical Tropical Medicine, Faculty of Tropical Medicine Mahidol     University,Bamrasnaradura Infectious Disease Institute      ,Pramonkutklao Hospital,Rajavithi Hospital,NationalCancerInstitute,Institute of     Dermatology,Raj Pracha Samasai Institute      OBJECTIVES        -  Measure the burden of illness due to herpes zoster (Zoster) and post-herpetic neuralgia          (PHN) (severity and duration);        -  Assess the quality of life (QoL) and quality adjusted life years (QALY) lost due to          Zoster and PHN;        -  Describe health care resource utilization associated with Zoster and PHN;        -  Describe the direct and indirect costs per case of Zoster and PHN   "
205560|NCT00526877|"     The purpose of this study is to evaluate the efficacy and safety of long-acting risperidone     microspheres (small uniformly-sized spherical particles, of micrometer dimensions, frequently     labeled with radioisotopes or various reagents acting as tags or markers) in participants     with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment     from reality, often with delusions and hallucinations, and withdrawal into the self) and     schizoaffective disorders (a mixed psychiatric disorder relating to a complex psychotic state     that has features of both schizophrenia and a mood disorder such as bipolar disorder), who     are receiving psychiatric home-care treatment .   "
205561|NCT00526890|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with     selenomethionine and radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well selenomethionine works     when given together with carboplatin, paclitaxel, and radiation therapy in treating patients     with stage III non-small cell lung cancer that cannot be removed by surgery.   "
205562|NCT00526903|"     The purpose of this study is to:        1. To determine if fiber versus placebo improves symptoms in children with recurrent          abdominal pain/irritable bowel syndrome.        2. To determine possible ways fiber or placebo improve(s) symptoms in children with          recurrent abdominal pain/irritable bowel syndrome by carrying out gastrointestinal tests          and questionnaires.      Understanding how diet and fiber affect GI function potentially will benefit the large     numbers of children with irritable bowel syndrome (IBS) and provide insight into prevention     of IBS in at risk children. We expect that the results from these studies can be used to     lessen significantly the huge financial burden to society caused by these chronic conditions.      Consent will be obtained from the parent/guardian and assent from the child.   "
205563|NCT00526916|"     The purpose of this protocol is to measure peripheral benzodiazepine receptors in the brain     using positron emission tomography (PET) and compare the imaging results between patients and     healthy people.   "
205564|NCT00526929|"     Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with     Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time     blood will be drawn and vital signs will be taken. Upon enrollment, subjects will receive SC     darbepoetin alfa administered once every other week for 24 weeks. Darbepoetin alfa will be     titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. During the study,     laboratory assessments will be completed and vital signs will be taken. Subjects will enter a     1-week post-treatment observation and evaluation period after the last dose of study drug.   "
225836|NCT00808756|"     The purpose of this project is to study the effect of fermentable carbohydrates in the     nutrition of healthy infants.   "
205571|NCT00527020|"     GSK1018921 is a new drug under development for the treatment of schizophrenia. GSK1018921     differs from other available drugs in its mode of action and it is assumed that it may have     an effect in the treatment of so-called positive symptoms such as hallucinations and negative     symptoms such as lack of drive. No clinical studies have been conducted with GSK1018921 in     humans until now. This is the first study where this compound is administered to humans; the     study has 2 parts: Part A is a dose escalation study, Part B is a pharmacodynamic portion in     a separate group of healthy smoker volunteers.   "
205572|NCT00527033|"     Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability     compared to placebo   "
205573|NCT00527046|"     A 24-month, placebo controlled, double dummy, parallel-design outpatient trial in generally     healthy elderly men and women who are at risk of becoming frail.   "
205574|NCT00527059|"     The purpose of this study is to evaluate the effect of levosimendan infusion, in addition to     standard therapy,on renal function in patients with Acute Heart Failure,compared with     standard therapy alone.   "
205575|NCT00527072|"     The purpose of this study is to test the safety and effectiveness of infliximab in patients     with plaque psoriasis who have been receiving the drug etanercept for treatment of their     plaque psoriasis for at least four months, without enough improvement in their psoriasis     symptoms.   "
205576|NCT00527085|"     4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the     study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In     addition, a bone biopsy will be performed at screening and at the end of study.   "
205577|NCT00527098|"     The purpose of this study is to determine if the overall fluid requirements for the first 24     hours after admission will be reduced with Hextend versus a standard of care crystalloid     resuscitation fluid.   "
205578|NCT00527111|"     The purpose of this research study is to find out what effects (good and bad) cetuximab has     on rectal cancer.   "
205579|NCT00527124|"     This randomized phase II trial is studying how well giving docetaxel and prednisone together     with or without cediranib works in treating patients with metastatic prostate cancer that did     not respond to hormone therapy. Drugs used in chemotherapy, such as docetaxel and prednisone,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Cediranib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel     together with prednisone, with or without cediranib, may kill more tumor cells.   "
205580|NCT00527137|"     Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger.     Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and     baseline period. During the study, procedures include bloodwork for laboratory assessments     and vital signs. Dose titration determined by hemoglobin values taken weekly during the     study. Antibody samples taken at baseline and during the end of study assessments. A physical     examination and laboratory tests will conclude the study.   "
205581|NCT00527150|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     escalating multiple oral doses of varenicline AMT 8 controlled release formulation for 14     days in adult smokers.   "
205582|NCT00527163|"     This study, conducted by NIH, the University of Bamako in Mali, Africa, and Tulane University     will examine the relationships between hemolysis (breakdown of red blood cells), nitric oxide     (a gas important in regulating blood vessel dilation and blood flow) and pulmonary     hypertension in patients with malaria. Malaria is among the leading causes of death in many     of the world s poorest countries. It is caused by a parasite that is transmitted to humans by     mosquitoes.      Malian children ages 1-5 years are eligible for participation in this study. They include     children with asymptomatic infection, uncomplicated disease, and severe disease. Uninfected     controls are also included.      Upon enrollment, participants have a medical history and physical examination, echocardiogram     (ultrasound test of heart function) and blood tests. In addition, all participants (infected     children and controls) have repeat evaluations when healthy, approximately 7 to10 days     following successful therapy.   "
205583|NCT00527176|"     In daily clinical use, pulse high dosis corticosteroids are used to treat cerebral edema in     different pathological situations ( surgery, trauma, tumors...). Dehydration can theorically     concern extra-cellular or intracellular water, or both.      The relative proportion of those two components are not known, as well their kinetics.      Diffusion Weighted Imaging ( DWI) is a none invasive and none toxic technique to study those     phenomena.We can also study the diffusivity anisotropy not using a Gaussian distribution but     rather a non- gaussian one, more close to the reality ( q Space Imaging ).      Finally, we can study the compartment redistribution between slow and rapid water molecules     diffusion by bi-exponential decomposition of the diffusion signal, corresponding,     theorically, respectively to the intra- and extra-cellular component.      Hypothesis : The high dosis steroid pulse therapy modifies or not the water free diffusion in     DWI and qSI ? Is there a modification in the diffusivity of both rapid and slow component ?   "
205584|NCT00527189|"     Arthritis has been reported as a risk factor for falls. Few studies have investigated the     effect of balance training on balance performance in women with lower limb arthritis. The aim     of this study was to evaluate the effectiveness of a four-month individualised home exercise     programme in improving gait stability and balance for women with arthritis.   "
205585|NCT00527202|"     Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A     injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve     trauma)   "
205586|NCT00527215|"     Multicenter, open label single arm study in which 140 subjects with CRI who are currently     receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every     4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa     once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total     dose in the month preceding enrollment. Doses may be titrated to maintain the Hb     concentration in the target range.   "
205589|NCT00527254|"     The purpose of this study is to evaluate the impact of a a real time teleassistance system in     the clinical evolution of type 2 diabetic patients on self monitoring blood glucose in the     Public National Primary Care System.   "
205590|NCT00527267|"     Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a     maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed     throughout the study along with PRO assessments.   "
205591|NCT00527280|"     To show the feasibility of face transplantation in patients   "
205592|NCT00527293|"     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill     tumor cells. Giving radiation therapy in different ways may kill more tumor cells.      PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in     treating women undergoing breast-conserving therapy for early stage breast cancer.   "
205593|NCT00527306|"     The purpose of this research study is to find out if taking a multivitamin daily can affect     the number of canker sores that people get and how long they last. Previous studies have     shown that people who get canker sores are more likely to be deficient in one or more     vitamins. It has also been found that correction of such vitamin deficiencies reduces the     number and duration of canker sores. However, it is not known if taking a multivitamin daily     will reduce the number and duration of canker sores.   "
205594|NCT00527319|"     Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a     hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are     not functioning and increased nutrition is not utilized.      To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy     must block multi-factorial stress signaling a threshold of activation. Consistent with the     synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with     advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of     VT-122 in subjects with NSCLC who have hypercatabolic cachexia.   "
205595|NCT00527332|"     The purpose of this study is to determine whether spinal anesthesia combined with intrathecal     morphine in abdominal hysterectomy on benign gynecological indications gives better outcome     concerning duration of hospital stay and postoperative patient comfort than general     anesthesia.   "
205596|NCT00527345|"     The contribution of diesel exhaust (DE) to health, especially children's health, is of     tremendous public health interest. DE has been associated with worsening asthma and     allergies, among other important health effects. Reducing DE exposures has become a major     regulatory initiative, and federal, state, and local jurisdictions are investing hundreds of     millions of dollars in retrofitting diesel engines in school buses and other changes to reach     this goal.      The U.S. Environmental Protection Agency's recent regulations require all on-road diesel     vehicles to change to low emission engines and ultra-low-sulfur fuels by 2007 (US EPA '00).     In spring 2003, the U.S. EPA announced a nationwide voluntary school bus retrofit initiative.     In July 2003, the Washington Legislature enacted a statewide Diesel Solutions program that     provides 25 million dollars by 2008 to retrofit school diesel buses with cleaner burning     engines and fuels, making it one of the largest and most active voluntary school bus retrofit     program in the country. If risk assessment estimates are accurate, these changes will have a     large public health impact, especially on children who ride school buses daily. However, no     studies to-date have rigorously examined school children's exposure to diesel exhaust (DE)     and its health effects, nor such a significant change in vehicular pollution control. We     propose to seize this opportunity of a large natural experiment taking place in the Puget     Sound area and conduct a study to assess health effects from diesel bus exhaust before and     after the retrofit of diesel bus fleets between 2005 and 2007. The specific aims of the study     are to:        1. Determine whether asthmatic children changing to retrofitted buses with cleaner fuels          and engines have a reduction in sub-clinical and clinical asthma severity.        2. Determine if increased levels of DE exposure lead to an increase in acute clinical and          sub-clinical features of asthma in children.        3. Quantify the levels and changes in particle and toxic gas exposures to DE in 3 groups of          children commuting to school by retrofitted buses or private cars, old diesel buses to          be retrofitted later, and old diesel buses through the study.      Sub-aim 3: Use the time-activity information, personal exposure measurements, and on-bus     monitoring data to construct an exposure model to predict individual exposures to DE for all     subjects.   "
205597|NCT00527358|"     This is an evaluation of a primary prevention program to prevent youth violence by improving     family cohesion, networking among families, school bonding, and access to services for     Latinos in Langley Park, MD.   "
205598|NCT00527371|"     In patients with an enlarged prostate (benign prostatic hyperplasia), is treatment using     photoselective vaporization of the prostate (PVP 120 Watt) as effective and cost-effective as     the standard treatment of transurethral resection of the prostate (TURP)? A higher-power     (120W) laser system has recently been approved by Health Canada for the treatment of an     enlarged prostate. This system, which uses laser energy to vaporize the prostate tissue, will     be compared with the current standard treatment of transurethral resection of the prostate.     This newer generation laser may offer more efficient removal of prostate tissue with fewer     complications and may result in clinical and economic benefits compared to the standard     treatment. However, there have been no studies comparing the 120W laser with the standard     transurethral resection of the prostate. This study will provide currently unavailable     information for clinicians and decision makers.   "
205599|NCT00527384|"     Physiological changes can occur from different types of stress as induced by an infection, an     environmental toxicant exposure, or an emotional disturbance. The stress-induced effects can     modify health by lessening defense mechanisms as maintained by the immune system. The ability     of different forms of stress to alter physiological processes (body functions) will be     assessed by monitoring the blood profile of cell numbers and functions as well as the plasma     protein content. It is anticipated that the pattern of blood changes will reflect the types     of stress and the degree to which body functions could be altered by the stress.   "
205600|NCT00527397|"     Assess the safety and toleration of CP-464,005 and Inhaler following 1-year (52 week)     administration to Type 1 and Type 2 diabetes patients (non-smokers)   "
205601|NCT00527410|"     This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in     recurrent neoplastic meningitis.   "
205602|NCT00527423|"     Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective     is to assess long-term safety and tolerability of continuing intravitreal treatment in     subjects with wet age-related macular degeneration.   "
205616|NCT00533689|"     THis study aims to determine whether frequent dosing of intravitreal injections of     Ranibizumab (Lucentis) or Bevacizumab (Avastin), which act as VEGF inhibitors, has a     deleterious effect on the retina, studied by electrophysiologic testing.      This prospective, non-randomized clinical study will include patients assigned to     intravitreal injection of Ranibizumab or Bevacizumab due to neovascular AMD. The patients     will undergo repeat ophthalmic evaluation and intravitreal injections every 4-6 weeks, as     long as will be deemed necessary. Periodic electrophysiologic evaluation including     Electroretinogram (ERG), electro-oculogram (EOG) and Visual Evoked Potentials (VEP) tests     will be performed every 3 months.   "
207922|NCT00569504|"     The purpose of this study is to assess the cross-sectional prevalence of the metabolic     syndrome in patients with schizophrenia taking antipsychotics.   "
205603|NCT00527436|"     Rationale Experimental data indicate an inverse relation between intake of omega-3 fatty     acids ('fish oil'), primarily in the form of eicosapentanoic acid (EPA) and docosahexanoic     acid (DHA), and risk of developing cardiovascular disease in healthy adults. Mechanisms     underlying this cardioprotective effect are unknown but may involve favorable influences on     various biomarkers of cardiovascular risk. In this project we will determine if these     favorable effects of omega-3's occur in older healthy adults, as aging is a primary risk     factor for cardiovascular disease development.      Key Objectives To determine the effect of chronic (12 week) oral omega-3 fatty acid     supplementation on biomarkers of cardiovascular risk in young and older adults. We     hypothesize that omega-3 fatty acid supplementation will exert positive effects on biomarkers     of cardiovascular risk.      Study Population Healthy young (18-40 years of age) and older (50-79) men and women.      Major Inclusion & Exclusion Criteria Subjects must be healthy (as assessed by history and     physical examination: non obese BMI<30: normotensive BP <140/90 mmHg) men and women not     currently taking medications that could influence the results. Women must be non-pregnant.     Normal liver enzymes (ALT and AST). Individuals with allergies to corn will be excluded.      Allocation to Groups Randomized, double-blinded, and placebo-controlled.      Summary of Procedures Measurements will be made at baseline and repeated ~12 weeks after     beginning daily oral ingestion of either low dose or high dose fish oil capsules or placebo   "
205604|NCT00527449|"     The purpose of this study is to optimize results in neoadjuvant chemotherapy of local     advanced primary breast cancer. Therefore patients become first 3 cycles of     Epirubicin/Docetaxel followed by 3x Carboplatin/Docetaxel.   "
205605|NCT00527462|"     The aim of the study is to test the hypothesis that the allergic airway inflammation in     asthmatic patients will be enhanced after exposure to ultrafine particles (UFP). In order to     test this in a controlled study, the researchers combine controlled exposure to carbon black     model UFP with the well-established model of a segmental allergen challenge, which allows the     researchers to safely induce circumscript allergic inflammation in the lung in mild     asthmatics. The effect of the UFP on allergic inflammation will be controlled by an     inhalation of clean air in a randomized, double-blind, crossover design.   "
205606|NCT00527475|"     Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set     the standard for visual outcomes in treating wet macular degeneration. However, they need to     be administered frequently by intraocular injections with the attendant risk of     endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of     this trial is to see if using photodynamic therapy in combination with ranibizumab will     decrease the number of treatments with ranibizumab.   "
205607|NCT00527488|"     This exploratory study will be conducted open label in a single investigational clinical     unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned     to receive 4 different treatments with degarelix.   "
205608|NCT00532857|"     To evaluate the pathologic complete response rate to preoperative administration of     Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH)   "
205609|NCT00532870|"     The laparoscopic repair of ventral hernias is still a controversial therapeutic option. To     evaluate the efficacy and safety of laparoscopic repair we compare the results of the open     and laparoscopic repair of ventral hernia,. 53 patients were undergo laparoscopic or open     repair of ventral hernia . All defects were estimated to be larger than 5 cm in diameter.     Twenty six patients underwent attempted laparoscopic ventral hernia repair (LVHR) with mesh     and twenty seven patients underwent open ventral hernia repair (OVHR) with mesh   "
205610|NCT00532883|"     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease     that can cause intense pain episodes. Hemoglobin SCD (HbSC) is a form of SCD that is     characterized by dense red blood cells. The purpose of this study is to evaluate the safety     and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red     blood cell density and the frequency of pain episodes in people with HbSC.   "
205611|NCT00532896|"     Increase in body mass index (BMI)is associated with a decrease in expiratory flows.Obesity is     also associated with an increased prevalence of asthma.Consequences of obesity on respiratory     function and on bronchial responsiveness are still to be documented.      This study aims to evaluate, before and after surgery, the impact of a bariatric surgery     (biliopancreatic diversion with duodenal switch)on respiratory function in patients with     morbid obesity .      Our hypothesis is that weight loss following bariatric surgery will induce significant     improvements in pulmonary function and airway responsiveness, and, as a consequence, a     reduction in respiratory symptoms,these changes being correlated with a reduction in systemic     markers of inflammation. Maintenance of weight loss after one year will permit the     persistence of these improvements   "
205612|NCT00532909|"     To determine the maximum tolerated dose of Vandetanib with a current standard first-line     chemotherapy regimen, capecitabine and oxaliplatin without and then with bevacizumab for the     first line treatment of metastatic colorectal cancer (CRC) and to define the dose limiting     toxicities associated with the combination.   "
205613|NCT00532922|"     The purpose of this study is to investigate real practices of treatment with Symbicort     Turbuhaler for 3 months in asthma and patient compliance.   "
205614|NCT00532935|"     A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used     medication in patients with type 2 diabetes   "
205615|NCT00532948|"     This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities,     of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed     diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered     twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of     radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard     dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week     break. The anticipated time on study treatment is 3-12 months, and the target sample size     will not exceed 30 evaluable patients.   "
205617|NCT00533702|"     The primary objective of this study is to determine the progression-free survival (PFS) of     participants with previously untreated metastatic malignant melanoma when treated with     IMC-1121B (ramucirumab) alone or in combination with dacarbazine.   "
206177|NCT00546689|"     Correlation between intestinal parasites and serum level of eosinophils and IgE in     individuals with HIV or aids attended at clinical hospital of the Botucatu Medical     School-UNESP   "
205618|NCT00533715|"     Spirometry testing should include both expiratory and inspiratory measurements as it may     influence the expiratory flow volume curve indices. The ability to inhale medication may by     judged by inspiratory flows. However, the inspiratory portion of the forced flow/volume     maneuver in young healthy children has not yet been described.Objectives: To document and     analyze the forced inspiratory flow volume curve indices in healthy young children.      Settings: Community kindergartens around Israel. participants; Healthy preschool children     (age 2.5-6.5 years).      Methods: The teaching method included multi-target, interactive spirometry games (SpiroGame®)     and accessory games for inspiration (e.g. inspiratory whistle).      Results: One hundred and fourteen of 157 children performed duplicate full adequate     inspiratory maneuvers. Repeatability between two maneuvers was 5.6%, 4.0%, 5.1%, 7.3% for     inspiratory capacity (IVC), forced inspiratory capacity (FIVC), peak inspiratory capacity     (PIF), and mid inspiratory flow (MIF50), respectively. Inspiratory flow indices were     significantly lower than the parallel expiratory flow indices and the time to reach PIF was     significantly slower than the time to reach peak expiratory flow (meanSD; 22921ms vs. 92     8ms; p<0.0001). The shape of the inspiratory curve was parabolic and did not change with     age. Predicted equations that were formed were in agreement with the extrapolated prediction     equation values of older children.      We found that the majority of healthy young children can produce reliable inspiratory curves.     Our results provide a framework for reference equations for inspiratory flow volume curve in     the young ages. The clinical applications of these equations are yet to be explored.   "
205619|NCT00533728|"     The purpose of this study is to assess the safety of soluble beta-glucan (SBG) in combination     with antibody and chemotherapy treatment in patients with non-Hodgkin-s lymphoma.   "
205620|NCT00533741|"     Severe acute respiratory syndrome (SARS) is a viral illness that affects the respiratory     (breathing) system. The purpose of this study is to evaluate the safety and protective     (immune) responses to different doses of a SARS vaccine given with or without an adjuvant. An     adjuvant is a substance that may be added to a vaccine to improve the immune response so that     less of the vaccine may need to be given. Study participants will include 72 volunteers, ages     18-40, living in the Houston, Texas area. The study will take place at Baylor College of     Medicine. Participants will receive 2 injections of vaccine or placebo (substance made to     look like the study vaccine but contains no medication) given 1 month apart. Participants     will fill out a memory aid (diary) to document daily temperature and illness signs and     symptoms for 7-9 days after each injection. During the 9 study visits, several blood samples     will be collected. Participants will be in the study for up to 211 days, including screening.   "
205621|NCT00533754|"     The aim of the study is to show a higher expression of the Y402H polymorphism in the     complement factor H in patients with AMD compared to healthy individuals.      Additionaly a correlation between a subsided infection with chlamydia and patients with AMD     and a factor H polymorphism will be investigated. An interrelationship with the VEGF-plasma     level shall give more hints into the pathomechanism of AMD.   "
205622|NCT00533767|"     This study is designed to evaluate the transmission of hantavirus in Chile. It is an     observational study that will look at close household contacts of people who have been     diagnosed with hantavirus infections that result in a serious illness to see how frequently     they become infected. Subjects who enroll in the study will donate samples of body fluids     (e.g., blood, saliva, stool, urine, respiratory and vaginal secretions) to allow the     researchers to see if hantavirus is present in those fluids and if so, how much. Subjects     will also be interviewed to identify household conditions that may be associated with     transmission. Up to 76 index cases (people who are first diagnosed with hantavirus     cadiopulmonary illness) and up to 140 of their close contacts will be enrolled. Subjects will     be followed for about 6 weeks.   "
205623|NCT00533780|"     To learn what effect, if any, Healing Touch (a gentle, non-invasive form of energy work that     promotes relaxation and can help manage the side effects of chemotherapy and radiation), has     on physical symptoms, mood, and qualify of life for women undergoing treatment for breast     cancer.   "
205624|NCT00533793|"     A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group,     international multi-center study. The study will consist of four treatment groups - one     control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or     1.0 mg/mL I-040202.   "
205625|NCT00533806|"     This study will compare the effectiveness of family-based cognitive behavioral therapy to     family-based relaxation therapy in treating young children with obsessive-compulsive     disorder.   "
205626|NCT00533819|"     Healthy physical activity decreases blood pressure in young female school children. It also     has effects on BMI and maths scores.   "
205627|NCT00533832|"     To confirm the safety and efficacy of the NCP System in treating patients in a nmajor     depressive episode.   "
205628|NCT00533845|"     After Laparoscopic surgery most patients experience some form of mild to moderate pain. The     current standard of care is to treat this pain with local anesthetics (numbing medication,     that deadens the nerve endings) to the small surgical incisions (cuts) and narcotic systemic     analgesics (medication injected into your vein to control pain such as morphine).      Although this treatment improves pain symptoms it is not perfect. Firstly, complete pain     control is rarely achieved and secondly, narcotics (such as morphine) often have many side     effects including nausea, vomiting, sedation (sleepiness), constipation and abdominal upset.     All of these issues make recovery less comfortable and delays return to full function (work,     school and other activities of daily life).      A new FDA approved device is now available that offers the benefits of long term anesthesia     without the side effects of narcotics. It consists of a pump that continuously infuses local     anesthesia into and around the surgical site. This pump is placed during your operation. You     then carry a tennis ball sized container made of soft plastic in a pouch which drips numbing     medicine around your wounds for 2 days continuously.      The purpose of this study is to see if this pump improves postoperative pain, decreases the     need for narcotic pain medicine and allows people to return to their activities earlier.   "
205629|NCT00533858|"     The aim of this study is to evaluate the effect of lacidipine and losartan in elderly     hypertensive patients on reducing the 24 hour systolic BP variability, which is one of the     potential parameter to consider in treating elderly hypertensive patients.   "
225837|NCT00808769|"     The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on     gastric acid suppression.   "
205630|NCT00533871|"     Preeclampsia is a common disease state occurring in the third trimester of pregnancy, with an     incidence of approximately 5-10% in the US. Hypertension (high blood pressure), a primary     symptom of pre-eclampsia, may be present in women who were hypertensive prior to becoming     pregnant.B-type (also known as brain) natriuretic peptide (BNP) is known to be made and     released from the heart ventricles when the heart is strained. There is also evidence that     BNP is secreted in the placenta, and may increase in preeclampsia and chronic hypertension in     pregnancy.The purpose of the study is to determine if a maternal blood sample analyzed for     the quantity of BNP is helpful in differentiating between pre-eclampsia and chronic high     blood pressure.   "
205631|NCT00533884|"     RATIONALE: Gathering information about how often problems with neurocognitive functioning     occur in patients with newly diagnosed upper aerodigestive tract cancers may help doctors     learn more about the disease.      PURPOSE: This clinical trial is studying neurocognitive functioning in patients with newly     diagnosed upper aerodigestive tract cancers receiving treatment at Henry-Joyce Cancer Clinic.   "
205632|NCT00533897|"     The purpose of the study is to determine whether subcutaneous abatacept administered to     patients with rheumatoid arthritis is associated with increased immunogenicity or increased     safety events upon withdrawal and reintroduction.   "
205633|NCT00533910|"     The purpose of this study is to determine whether alteration of gut flora with rifaximin can     lead to improvement in driving performance, psychometric test performance, and quality of     life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized,     blinded, placebo-controlled trial.   "
205634|NCT00533923|"     Allogeneic stem cell transplantation may provide long-term remissions for some patients with     hematological malignancies. However, allogeneic transplantation is associated with a     significant risk of potentially life threatening complications due to the effects of     chemotherapy and radiation on the body and the risks of serious infection. In addition,     patients may develop a condition called Graft versus host disease that arises from an     inflammatory reaction of the donor cells against the recipient's normal tissues. The risk of     graft versus host disease is somewhat increased in patients who are receiving a transplant     from an unrelated donor.      One approach to reduce the toxicity of allogeneic transplantation is a strategy call     nonmyeloablative or mini transplants. In this approach, patients receive a lower dose of     chemotherapy in an effort to limit treatment related side effects. Patients undergoing this     kind of transplant remain at risk for graft versus host disease particularly if they receive     a transplant from an unrelated donor. The purpose of this research study is to examine the     ability of a drug called CAMPATH-1H to reduce the risk of graft versus host disease and make     transplantation safer. CAMPATH-1H binds to and eliminates cells in the system such as T cells     that can cause graft versus host disease (GvHD). As a result, earlier studies have shown that     patients who receive CAMPATH-1H with an allogeneic transplant have a lower risk of GvHD. In     the present study, we will examine the impact of treatment with CAMPATH-1H as part of an     allogeneic transplant on the development of GvHD and infection. In addition, we will study     the effects of CAMPATH-1H on the immune system by testing blood samples in the laboratory.   "
205635|NCT00533936|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as trastuzumab, can block tumor growth in different ways. Some block the ability of     tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Giving combination chemotherapy together with trastuzumab     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs     to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after     surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses.     In this case, observation may be sufficient. It is not yet known whether trastuzumab is more     effective than observation when given after combination chemotherapy and trastuzumab in     treating patients with breast cancer.      PURPOSE: This randomized phase II trial is studying trastuzumab to see how well it works     compared with observation when given after combination chemotherapy and trastuzumab in     treating patients undergoing surgery for stage II or stage III breast cancer.   "
205636|NCT00533949|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as cetuximab can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. It is not yet known whether high-dose radiation     therapy is more effective than standard-dose radiation therapy when given together with     combination chemotherapy with or without cetuximab in treating patients with non-small cell     lung cancer.      PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation     therapy given together with chemotherapy with or without cetuximab to see how well they work     in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be     removed by surgery.   "
205637|NCT00533962|"     Introduction: Ocular administration of glucocorticoids is a common and effective treatment     for several ocular diseases. However it is often complicated with the elevation of     intraocular pressure (IOP). Anecortave acetate (AA) is an analog of cortisol acetate and     lacks the typical anti-inflammatory and immunosuppressive properties of glucocorticoids. The     effect of its anterior juxtascleral depot (AJD) injection has been evaluated in cases of     glaucoma caused by intravitreal triamcinolone acetonide, presenting impressive results. The     purpose of this study is to evaluate the efficacy and safety of the AA injection as a     possible antiglaucoma treatment alternative. Methods: A prospective clinical study will be     carried out including 30 glaucoma patients (30 eyes). After inclusion each patient will     receive a single AJD injection of 30 mg of AA in the selected eye. Main outcome measure     include: intraocular pressure at 1st day, 7th day, 1st, 2nd and 3rd months.   "
205638|NCT00533975|"     The purpose of our study is to evaluate the diagnostic validity of a new immunofecal occult     blood test (IFOBT) (Teco Diagnostics) in U.S. veterans and to compare it with the guaiac     based FOBT.   "
205705|NCT00534859|"     The objective of this feasibility study is to demonstrate that the device is safe and     potentially efficacious for use in patients undergoing high risk Percutaneous Coronary     Interventions(PCI).Patients will be enrolled if they meet inclusion & exclusion criteria.   "
205639|NCT00533988|"     Intravascular devices are an integral component of modern-day medical practice. Infection is     one of the leading complications of intravascular catheters and is associated with an     increased mortality, prolonged hospitalization and increased medical costs. Central venous     catheters (CVCs) account for an estimated 90% of all catheter-related bloodstream infections     (CRBSI). A host of risk factors for CVC-related infections have been documented. This     includes most importantly, duration of catheterization. The duration of use of CVCs remains     controversial and the length of time such devices can safely be left in situ has not been     fully and objectively addressed in the critically ill patient. As a consequence, scheduled     replacement remains widely practiced in many Intensive Care Units(ICUs). Over the past few     years, antimicrobial impregnated catheters have been introduced in an attempt to limit     catheter-related infection (CRI) and increase the time that CVCs can safely be left in place.     Recent meta-analyses concluded that antimicrobial impregnated CVCs appear to be effective in     reducing CRI. The topic however, remains extremely controversial with different viewpoints     appearing in the literature recently.      This was a prospective randomized double-blind study performed in the multidisciplinary ICU     at Johannesburg Hospital over a four year period.The study entailed a comparison of standard     triple-lumen versus antimicrobial impregnated CVCs on the rate of CRI. The aim was to     determine whether the researchers could safely increase the duration of catheter insertion     time from the standard practice of seven days to 14 days, to assess the influence of the     antimicrobial impregnated catheter on the incidence of CRI, evaluate risk factors and     elucidate the epidemiology of CRI.   "
205640|NCT00534001|"     RATIONALE: Bupropion may help people stop smoking by decreasing the symptoms of nicotine     withdrawal. Giving bupropion over a longer period of time may be effective in helping people     stop smoking.      PURPOSE: This randomized phase II trial is studying how well bupropion works in helping     adults stop smoking.   "
205641|NCT00534014|"     Study Goal #1: Determine the optimal oral dose of vitamin C to reduce surrogate markers of     atherosclerosis (blockages in blood vessels) following the consumption of an atherogenic high     fat lunch in type 2 diabetic individuals.      Study Goal #2: After conducting the original study, we found that vitamin E was not effective     in reducing the markers of oxidative stress, hypercoagulation, inflammation, and metabolic     parameters in patients with type 2 diabetes.      To date, data from randomized trials have largely demonstrated no significant benefit of     vitamin E supplementation on the prevention of primary and/or secondary cardiovascular     disease as once thought. Therefore, we decided to amend our current protocol to add a Part B     to study only the effects of vitamin C at the following doses: 500 mg, 1000 mg, and 2000 mg     daily (and include a placebo arm, as well.   "
205642|NCT00534027|"     Part 1 is complete. Part 2 is a multi-center, randomized, double-blind, placebo-controlled,     phase 2 segment that will commence upon identification of the maximum tolerated dose in part     1. The Primary objective of Part 2 of the study is to estimate efficacy in combination with     carboplatin and paclitaxel. Subjects will be randomized at a 1:1:1 ratio to 1 of 3 treatment     arms. Subjects in each of the 3 arms will receive up to 6 cycles of paclitaxel/carboplatin     (at the same dose and schedule in part 1) in combination with either AMG 655 at the maximum     tolerated dose (Arm 1), AMG 655 at a lower dose (Arm 2), or AMG 655 placebo (Arm 3) IV Q3W.     Randomization will be stratified by ECOG (0 or 1) and disease stage (IIIb or IV/recurrent).   "
205643|NCT00534053|"     The purpose of our randomized controlled trial is to determine whether mailed educational     reminders would increase fecal occult blood test (FOBT) card return rates and, therefore,     improve patient compliance with colonrectal cancer (CRC) screening.      We will conduct a randomized, controlled trial to evaluate the hypothesis that compliance to     FOBT referrals is at least 10% greater among patients who receive mailed educational     reminders on the importance of CRC screening. The study will be conducted in Veteran Affairs     Medical Center and surrounding VA clinics in San Diego.   "
205644|NCT00534066|"     The purpose of the study is to determine if a series of BNP blood tests performed on patients     who present to the Emergency Department with congestive heart failure (CHF) can predict which     patients may have adverse outcomes. If the BNP is shown to be predictive of bad outcomes in     certain patients, those patients might receive more intensive therapy early to prevent such     outcomes. This was a prospective trial enrolling patients who presented to the ED and were     diagnosed with heart failure. Subjects had a blood test for BNP, which is elevated in the     presence of heart failure, collected twelve hours after their initial clinical BNP was     obtained in the ED. Demographics, history, length of hospital stay, and other approved data     were collected. At 30 days and 6 months after discharge, a follow up call was made to     determine if the subject had required additional emergency care, had been admitted to a     hospital, or had died during that period of time.   "
205645|NCT00534079|"     Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality     of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a     dysfunction of chloride channels in exocrine glands, leading to retention of secretions and     consecutive chronic inflammation with bacterial superinfections.      The prospective placebo controlled cross-over study aims at the evaluation of a nasally     inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.   "
205646|NCT00534092|"     The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all     patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol     (CAP), or Cross-over Study (COS). It is designed to supplement postmarket safety and     effectiveness data to be gathered in a Condition of Approval (CoA) study of a population of     patients with moderately impaired physical function who elect to undergo X-STOP surgery.   "
205656|NCT00534222|"     With this observational study we want to examine if the intensity of agitation, the intensity     of psychotic symptoms and the presence of sleeping disorder predict the success of the     treatment with a atypical antipsychotic after 12 weeks of treatment with patients with a     psychotic and/or manic episode. In this study it will be examined what the percentage of     patients with a 2-point improvement at the CGI-scale is. Of these group, the responders,     retrospective the profile of the responders will be analysed (key-factors and confounders).      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
205657|NCT00534235|"     Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs.     Fusion to Treat Lumbar Spinal Stenosis   "
205647|NCT00534105|"     The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an     exaggerated lipid response compared to non-gestational diabetics. If a difference is noted,     further studies will explore the possibility of screening gestational diabetics during their     pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk     for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction     and placental disease will be explored.      This will be a prospective cohort study. As part of routine prenatal care, women receive a     one hour glucose challenge test to screen for gestational diabetes. Those women with elevated     values then require a three hour glucose tolerance test, which is a diagnostic test for     gestational diabetes. All women that are scheduled to receive a three hour GTT will be     identified and ask to enroll in this study. 46 women whose three hour GTT is normal and thus     do not have GDM, will be compared to 46 women with an abnormal three hour GTT and thus would     have the diagnosis of GDM. Enrolled women will have a lipid panel consisting of; total     cholesterol, triglycerides, HDL and LDL cholesterol at the time of their fasting glucose     blood sample. In addition, a repeat lipid panel will be sent at the time of the third hour     sample, to assess changes, if any due to the glucose challenge. Umbilical cord blood samples     will be sent in order to obtain newborn lipid profiles. Women in both the GDM and normal     groups will be asked to return 6-8 weeks   "
205648|NCT00534118|"     RATIONALE: Giving an infusion of donor lymphocytes may be able to kill cancer cells in     patients with hematologic cancer that has come back after a donor stem cell transplant.      PURPOSE: This clinical trial is studying how well donor lymphocyte infusion works in treating     patients with recurrent or persistent hematologic cancer after donor stem cell transplant.   "
205649|NCT00534131|"     Anal sphincter preserving operations are now commonplace for both cancer and non-cancerous     rectal diseases. However, this has not always been the case and this development has been     facilitated by the invention of circular stapling instruments, which allow the bowel to be     reconnected to the anal sphincters, where it would almost be impossible to do so manually.     Nevertheless, some patients still require a permanent ostomy, as even with stapling devices     ultra low joins of the bowel and sphincter muscles cannot always be performed by a     conventional surgery. Therefore, a variety of alternative techniques have been proposed to     avoid a permanent ostomy, but these have not become widespread due to the technical     difficulty in performing them, their failure to completely eradicate rectal disease, and the     damage they inflict upon the anal sphincters resulting in poor bowel function after surgery.      The ideal ultra low sphincter preserving operation should remove the rectal disease entirely,     allow the small or large bowel to be safely joined to the anal sphincters under direct     vision, and retain the sphincter mechanism in its entirety. We propose such a technique that     we term the APPEAR procedure, which approaches the lower third of the rectum via an incision     between the scrotum or vagina, and the anal sphincters. This procedure preserves sphincter     integrity, and allows either a stapled or manual join of the bowel to the sphincter     mechanism, under direct vision. This trial is being conducted as a pilot study, with the     procedure only offered to patients for whom a conventional sphincter saving procedure was     technically impossible, or contraindicated.   "
205650|NCT00534144|"     This study will compare the effects of sodium ferric gluconate complex and iron sucrose on     urine concentrations of various chemicals including protein   "
205651|NCT00534157|"     The purpose of this study is to determine if the pressure in the eye of a severely     head-injured person correlates with the pressure in the person's skull. This is a prospective     study of patients aged 18 and older who have experienced a traumatic closed head injury and     are intubated either before or during the time they are in the Emergency Department (ED).     Identified patients have an eye pressure measurement performed in the trauma bay by an OSU ED     physician not involved in their care. Information about their hospital stay, including the     first brain pressure measurement if a such a measuring device is used, will be collected. In     addition, the outcome of their hospital stay will be recorded.   "
205652|NCT00534170|"     A therapeutic as well as preventive role of probiotics has been suggested from results of     different studies using different probiotics that have been tested, usually lactic acid     producing bacteria such as lactobacillus, bifidobacterium and streptococcus species. The     supplementation of probiotics to infants may also have a prophylactic effect against acute     diarrhoeal diseases.      In the present proposal, we plan to examine if daily intake of a probiotic beverage, which     includes 15 billion probiotic Lactobacilli, has a beneficial role in protecting children from     infectious diarrhea in Kolkata.      OBJECTIVES      Primary objectives:        1. To assess the impact of probiotics in the prevention of acute diarrhoeal diseases in          children        2. To assess the impact of probiotics on nutrition and growth of the children      Secondary Objectives:        1. Reduction in duration, frequency of diarrhoea        2. Identification of pathogens causing diarrhoea        3. Examination of faecal microflora      STUDY DESIGN      It will be a double blind randomized controlled field trial involving 4000 children aged     between 1 and 5 years in an urban slum of Kolkata, India. The 4000 children will be     identified through demographic survey. The study will be double blinded where the study arm     will receive Probiotic drink, which includes 15 billion probiotic Lactobacilli, one bottle     (65ml) daily (under supervision of a Health Worker) for 12 weeks and the control arm will     receive a similar drink without the lactobacilli (Nutrient drink) daily for 12 weeks.     Randomization will be done in a ratio of 1:1, i.e., the study arm and control arm will     include 2000 children each. All the children under the study will be visited daily by a     health worker who will supervise intake of Probiotic drink or Nutrient drink by the children.     All the children will be followed up daily for 24weeks for identification of acute diarrhoea     cases.   "
205653|NCT00534183|"     No clinical differences will be found between the three antipsychotics under study -     olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight.    "
205654|NCT00534196|"     RATIONALE: Implant radiation therapy delivers a high dose of radiation directly to the tumor     may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This clinical trial is studying the side effects and how well implant radiation     therapy using radioactive iodine works in treating patients with localized prostate cancer.   "
205655|NCT00534209|"     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune     response to kill tumor cells.      PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and     to see how well it works in treating patients with stage IIIB or stage IV non-small cell lung     cancer who have finished first-line chemotherapy.   "
205658|NCT00534248|"     This study will look at how well Zostavax™ works in preventing shingles in participants ages     50-59 years old.   "
205659|NCT00534261|"     This study was to find out if patients with Relapsing Remitting Multiple Sclerosis treated     with Interferon beta-1a had an improved quality of life after treatment with Interferon     beta-1a   "
205706|NCT00534872|"     The purpose of this study is to determine the blood levels and the tolerability of SB-649868     in Elderly and Female population   "
205660|NCT00534274|"     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using     3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy     before surgery in treating locally advanced breast cancer.      PURPOSE: This clinical trial is studying how well positron emission tomography using     3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one     breast who are receiving chemotherapy.   "
205661|NCT00534287|"     Severe sepsis and septic shock are diseases of infectious origin with a high risk of death.     Antibiotic therapy is mandatory but it is unknown whether one antibiotic alone is sufficient     for initial therapy. The purpose of this study is to compare a therapy with meropenem alone     or the combination of meropenem plus moxifloxacin in the treatment of severe sepsis/ septic     shock. Patients randomly receive one of the two treatments for at least 7 days but not longer     than 14 days.   "
205662|NCT00534300|"     The long-chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA) and     docosahexaenoic acid (DHA), appear to offer protection against sudden cardiac death and     ventricular arrhythmias. EPA and DHA are essential fatty acids which are incorporated into     cellular membranes after regular ingestion of fatty fish or fish oil.      This study investigates a possible acute effect of intravenous infusion of n-3 PUFA on     inducibility of ventricular tachycardia (VT) in patients with an ICD-pacemaker.      The hypothesis is that an acute rise in the concentration of n-3 PUFA in plasma will increase     the electric stability of the myocardial cells, so that VT is more difficult to induce.      In a randomized, placebo-controlled, double-blind, crossover study, a lipid emulsion with a     high content of n-3 PUFA (or placebo: isotonic saline) will be administered intravenously     before a non-invasive electrophysiologic examination performed via the ICD and following a     predefined protocol.      The main outcome is inducibility of VT. If sustained VT is induced in a patient after both     n-3 PUFA and placebo, the strength of the required stimulus after n-3 PUFA and after placebo     is compared.   "
205663|NCT00534313|"     The purpose of this study is to determine an optimal abatacept dosing regimen for the     treatment of active arthritis due to psoriatic arthritis in patients who have had a prior     inadequate response to disease-modifying antirheumatic drugs, including methotrexate and     tumor necrosis factor alpha-blockade compounds.   "
205664|NCT00534326|"     Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of     intramedullary nails for the fixation of long bone fractures. This study is designed to     compare the union rates between fractures reamed by standard reaming versus reaming with a     Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based     outcomes on these patients. Little information exists on the patient based outcomes following     femur fractures. We hope that the patient based outcomes of this study will also be able to     aid physicians in advising patients with femur fractures of their possible outcomes.   "
205665|NCT00534339|"     Safety, effectiveness, and performance of Allergan's EasyBand telemetrically adjustable     gastric banding device for the treatment of morbidly obese patients.   "
205666|NCT00534352|"     The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with     tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with     and without darunavir/ritonavir 800/100 mg once daily in HIV-1 infected, antiretroviral (ARV)     naÃ-ve patients (patients who have never received ARV treatment).   "
205667|NCT00534365|"     The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal     tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary     incontinence.   "
205668|NCT00534378|"     Purpose of the study is to determine midazolam's safety and dose-linearity when delivered     intramuscularly via an autoinjector. The proposed initial treatment dosage for seizures     induced by exposure to nerve agents.   "
205669|NCT00534391|"     To compare the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate,     polymyxin B sulfate and gramicidin) with placebo (artificial tear) in the treatment of     hordeolum after incision and curettage   "
205670|NCT00534404|"     People who smoke cigarettes have an increased risk of developing emphysema, heart disease,     and certain types of cancer. This study will evaluate the effectiveness of providing free     nicotine patches from an online smoking cessation program, with and without telephone     counseling, at improving quit rates in cigarette smokers.   "
205671|NCT00534417|"     The purpose of this study is to determine if the combination of continuous daily capecitabine     with fulvestrant on a loading dose schedule will delay disease progression in metastatic     breast cancer (MBC) patients.   "
205672|NCT00534430|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant     or a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and     helps stop the patient's immune system from rejecting the donor's stem cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving mycophenolate mofetil and cyclosporine before and after transplant may stop this from     happening.      PURPOSE: This phase II trial is studying the side effects and best way to give busulfan     together with etoposide and total-body irradiation and to see how well they work in treating     patients who are undergoing a donor stem cell or bone marrow transplant for advanced     hematologic cancer.   "
205673|NCT00534443|"     Although all PPIs are effective, there are some differences in their clinical performance,     particularly in terms of the degree and speed of gastric acid suppression. Few data are also     available about their effect of the pathophysiological mechanisms of gastritis and peptic     ulcer disease. Aim of the present study is to investigate the effect of therapy with     esomeprazole or rabeprazole on the mechanism of pathogenesis of gastritis and particularly on     the pattern of release of pro- and anti- inflammatory cytokines associated to peptic     ulcerative process by the gastric mucosa.   "
205674|NCT00534456|"     The purpose of Study 20060172 was to measure echocardiographic parameters and biomarkers in a     subgroup of study subjects enrolled in Study 20050222 (the RED-HF Trial). This substudy     20060172 was terminated early due to feasibility constraints. All subjects enrolled in     20060172 were also enrolled in Study 20050222, which is ongoing. Study data will be analyzed     when Study 20050222 ends, since unblinding before then would adversely affect Study 20050222.   "
205675|NCT00534469|"     RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of     cancer cells by stopping them from dividing or killing them. After treatment, stem cells are     collected from the patient's blood and/or bone marrow and stored. More chemotherapy and     radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem     cells are then returned to the patient to replace the blood-forming cells that were destroyed     by the chemotherapy and radiation therapy. Giving aldesleukin after transplant may help keep     cancer cells from coming back after transplant.      PURPOSE: This phase II trial is studying the side effects and how well giving busulfan and     etoposide together with total-body irradiation followed by autologous stem cell transplant     and aldesleukin works in treating patients with acute myeloid leukemia in first remission.   "
205676|NCT00534482|"     This research project brings together the American Academy of Family Physicians (AAFP)     National Research Network (AAFP-NRN) and the AAFP's public health initiative, Americans In     Motion (AIM). This project will develop and evaluate a practice improvement program to     improve family physicians' delivery of effective patient-centered behavior change     interventions for fitness (physical activity, nutrition and emotional well-being). The     investigators seek to develop a unique program that positions fitness in a central role as     the treatment of choice when dealing with issues of prevention and treatment of chronic     conditions. In addition, this newly developed program is intended to help shift the paradigm     of family physicians' use of common advice-giving methods to more effective patient-centered     lifestyle counseling. Ultimately, this program will seek to improve care for all patients     through fitness-related physician interventions.      Outcomes: This study design will allow the investigators to evaluate whether (and how)     dissemination of educational materials impacts patient intervention by first engaging     clinicians and staff in their personal use of these materials. This project will also     evaluate the effects of the behavioral change tools, as well as, the added impact of new     physiologic feedback measures (HOMA-IR and NMR Lipoprotein profiles) on physical activity and     diet in study participants.      Conclusion: Primary care offices can become more effective settings to help patients improve     physical activity, diet and emotional well-being. Demonstrating the value and impact of     creating healthy offices that endorse and support clinicians, office staff and patients in     the use of effective educational materials fits well with the new model of care as part of     the AAFP's Future of Family Medicine initiatives, which emphasize the importance of     lifestyle decisions and supporting successful changes in behaviors within primary care. This     project will help define how to accomplish this.   "
205677|NCT00534495|"     Systemic juvenile idiopathic arthritis (SJIA) is a type of arthritis that typically occurs     before 16 years of age. SJIA usually involves heat, pain, swelling, and stiffness in the     body's joints. It can also involve fever, rash, anemia, and inflammation in various parts of     the body. Rilonacept is a drug that can reduce inflammation. The purpose of this study is to     determine whether a rilonacept drug regimen initiated early is more effective than a similar     rilonacept drug regimen initiated 4 weeks later when treating children and young adults with     SJIA.   "
205678|NCT00534508|"     This study was designed to further increase the understanding of the pharmacokinetics of     tacrolimus in the affected skin of atopic dermatitis patients following repeated topical     application of tacrolimus ointment 0.1%.   "
205679|NCT00534521|"     The overall goal of this research is to determine the efficacy of a sham for posterior tibial     nerve stimulation (PTNS). This novel design is needed in order to have a sham treatment that     is similar to the actual treatment. The PTNS is used to treat urgency and frequency in people     with overactive bladder (OAB). Until research is done using a sham component, we are unable     to ascertain if the current use of PTNS is due to a placebo effect.   "
205680|NCT00534534|"     Retrospective studies have shown, that about half of the patients will have a recurrent     episode after the first acute alcoholic pancreatitis. Of the patients in hospital, more than     half annually are treated for recurrent acute pancreatitis. Because alcohol has been shown an     important factor in the development of recurrent pancreatitis, it was hypothesized, that by     attempting intensively to diminish the individual alcohol consumption the number of recurrent     pancreatitis could be decreased. Two protocols will be compared: A) initial intervention     against alcohol abuse and B) repeated interventions at 6 month intervals.   "
205681|NCT00534547|"     The purpose of this study is to investigate the role of an experimental surgery that may     offer better short and long-term control of T2DM in select patients who have not achieved     adequate blood sugar control with regular means.   "
205682|NCT00534560|"     Primary objective:      To investigate the efficacy and tolerability of two doses of tonabersat compared to placebo     in the prophylaxis of migraine headache and to evaluate the longer term tolerability of     tonabersat in an open label extension.      Secondary objective(s):      To obtain further data on the efficacy and dose response of tonabersat; To extend the safety     and tolerability database of tonabersat; To obtain data on the pharmacokinetics of     tonabersat.   "
205683|NCT00534573|"     Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable     adverse effect of clozapine therapy, and until now there is not enough effective treatment     for this side effect leading to noncompliance.      In previous studies it was found that substitute benzamide derivatives with higher selective     binding to the D2/D3 dopamine receptor - amisulpride and sulpiride may be effective in     treatment of clozapine-induced hypersalivation (CIH). Today, in psychiatric practice in     Israel, there are four medications which belong to substitute benzamide derivatives group:     amisulpride, sulpiride, tiapride and moclobemide. We hypothesized that antisalivation effect     is universal for the whole group of benzamide.      The aim of our study was to compare efficacy of amisulpride, moclobemide (reversible     monoamine oxidase inhibitor-A (RIMAS)), and tiapride (dopamine D2 antagonist) as an     additional possibility for management of CIH.   "
205684|NCT00534586|"     The aim of the present study is to investigate and quantify the influence of commonly used     anesthetics on auditory and pain evoked potentials.   "
205685|NCT00534599|"     This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL)     when added to standard selective serotonin reuptake inhibitor (SSRI) /     serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the     treatment of Generalized Anxiety Disorder in patients with partial or no response to     SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with     placebo   "
205686|NCT00534612|"     Liberal use of fine needle aspiration biopsy of parotid gland masses is controversial. All     information regarding this procedure has been retrospective. Our objective is to evaluate     prospectively the diagnostic accuracy of the test, alone and when associated to clinical     and/or radiologic data.   "
205687|NCT00534625|"     A single intravenous injection of zileuton (150 or 300 mg) will be administered to patients     with stable asthma. The goals will be to determine if zileuton i.v. can produce a rapid     increase in FEV1/PEFR and when this effect can be seen. The safety of this route of     administration of zileuton will also be studied. PK will be obtained in a population based     method.   "
205688|NCT00534638|"     Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and     women. The most important disease associated with oncogenic HPV infection is cervical cancer,     currently the second leading cause of cancer-related death among women globally. The current     study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15     years of age.      This protocol posting has been updated following protocol amendment 09, 24 March 2014. The     sections impacted are secondary objectives, endpoints, final analyses.   "
205689|NCT00534651|"     The purpose of this study is to determine the effect of orally given paracetamol on the     vascular function and on 24-hour blood pressure in patients with coronary artery disease   "
205690|NCT00534664|"     The goal of this study is to investigate the safety and feasibility of treating patients with     advanced hepatocellular carcinoma with a noninvasive device administering low level of     amplitude-modulated electromagnetic fields.   "
205691|NCT00534677|"     Terlipressin and Octreotide are two common agents used as adjuvants in the management of     variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in     randomized studies. There are no head to head clinical trials of these two agents available     in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide     in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with     Esophageal Variceal Bleed (EVB).   "
205692|NCT00534690|"     During general anesthesia, airway closure and the formation of atelectasis impair     oxygenation. During one-lung ventilation, large tidal volumes are used to resume atelectasis     with a risk of regional over distension and Ventilator-Induced Lung Injury (VILI). The     reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar     derecruitment. This harmful effect may be counteracted by PEP. We, therefore, study the     impact on oxygenation, of increasing PEP during OLV, in order to maintain alveolar     recruitment when TV is reduced.   "
205693|NCT00534703|"     The aim of the study is to determine the safety and feasibility of giving an adeno-associated     viral vector expressing the sarcoplasmic reticulum calcium ATPase (SERCA2a), driven by the     CMV promoter (AAV1-CMV-SERCA2a), to heart failure patients that have received a left     ventricular assist device (LVAD) for an accepted clinical indication. It is a randomised,     double-blind study of 24 patients that will be randomised to receive either the study drug     (AAV1.SERCA2a) or placebo.      The purpose of gene transfer of SERCA2a is to improve systolic and diastolic function of the     failing ventricle. Studies show that reduction of SERCA2a in failing ventricle is a key     factor in depression of contraction, and that restoration of SERCA2a levels can improve     function to near normal levels. The vector will be delivered during a cardiac catheterisation     procedure by a 10-minute infusion into the coronary arteries.      Myocardial tissue is obtained at the time of LVAD placement, as a routine part of device     implantation. Further samples will be obtained when the heart is transplanted or the LVAD     removed. Measures of tissue inflammation as well as efficacy of gene transfer will be made by     comparing these two samples. Recovery of contractile function of the heart will be assessed     during attempts to wean patients from the LVAD using standard protocols.      The results will be assessed in conjunction with two companion studies which will start     earlier in the US, one performing SERCA2a gene transfer with the same vector, but delivered     by direct injection into the myocardium during LVAD insertion, and one using AAV1-CMV-SERCA2a     delivered percutaneously in heart failure patients. The latter has both a dose-ranging and     placebo-controlled arm.   "
205694|NCT00534716|"     The purpose of this study on volunteers is whether THC and short-living metabolites are     suited to detect recent Cannabis smoking within urine doping control.   "
205695|NCT00534729|"     Organ Preservation: Weekly Carboplatin & Taxol w/concurrent RT for locally advanced laryngeal     & Hypopharyngeal CA   "
205696|NCT00534742|"     The exact etiology of ischemic stroke remains unclear, because multiple genetic     predispositions and environmental risk factors may be involved, and their interactions     dictate the complexity. Family-based studies provide unique features in design because of     their robustness to population admixture and stratification. The Fangshan / Family-based     Ischemic Stroke Study In China (FISSIC) program aims to conduct a genetic pedigree study of     ischemic stroke in rural communities of China.   "
205697|NCT00534755|"     Prospective & Retrospective data collection of breast cancer cases from 2000 to present   "
205698|NCT00534768|"     Objective: Even though postoperative debridement is commonly considered as an essential part     of endoscopic sinus surgery (ESS), the scientific data on the efficacy or the optimal timing     of debridement is limited. In the present study, the effect of repeated debridement during     the first week after ESS on the endoscopic and subjective outcome was evaluated.      Study Design: Open, prospective, randomized, controlled clinical trial with two parallel     groups.      Methods: A total of 90 patients suffering from either recurrent or chronic maxillary     sinusitis were randomized into two groups after ESS. In the active group, the nasal cavities     were debrided three times on the first postoperative week, while in the control group the     patients were debrided only once on the 7th postoperative day. The primary outcome measure     was the presence of scarring in the middle meatus at four weeks after ESS.   "
205699|NCT00534781|"     This is a research study to evaluate the outcomes after the study procedure for pain and     discomfort in the heel caused from an injury in the Achilles tendon which is located on the     back of the foot (commonly called Achilles tendinitis-Achilles tendinosis) that has not     gotten better with medicine and/or other therapy.      Researchers want to see if using the study device changes outcomes for 1 year after the study     procedure.   "
205700|NCT00534794|"     The purpose of this study is to compare the effects of two marked ocular anti-allergy     medications in cat sensitive subjects with allergic conjunctivitis.   "
205701|NCT00534807|"     The purpose of this study is to test how vinflunine interacts with rifampin in the human body   "
205702|NCT00534820|"     Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous     Stem Cell Transplantation in Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease   "
205703|NCT00534833|"     The present trial is a follow-up of AL203 study (NCT00343889).      Primary Objectives:      To describe the antibody persistence at 15 to 18 months of age and the booster effect of a     dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine     [OPV]).      Secondary Objective:      To describe the safety profile of a booster dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ when     administered concomitantly with OPV in each vaccine group.   "
205707|NCT00534885|"     A double-blind, randomized and controlled clinical trial was conducted in healthy children     aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of     a preservative-free inactivated hepatitis A vaccine (Healive®).      Participants who completed their primary vaccination were invited to participate in the     follow-up phase. Written informed consents were obtained from them. The follow-up study was     open-label. These subjects were visited annually in the next 5 years for blood sampling and     assessment of immune persistence induced by vaccination.   "
205708|NCT00534898|"     Background: In this proposed study, we aim to investigate safety and efficacy of two     synthetic retinoids - bexarotene (Targretin; LGD1069;     4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) and     fenretinide (Dihydroceramide N-(4-Hydroxyphenyl retinamide) on severity of psychopathology     and cognitive impairment in schizophrenia patients in an double-blind, placebo-controlled     study. The rationale behind add-on these medications to ongoing antipsychotic treatment in     schizophrenia patients is based on both the retinoid dysregulation hypothesis: the growth     factors deficiency and synaptic destabilization hypothesis of schizophrenia. Furthermore, in     our preliminary open clinical trial, we found that a low dose of bexarotene (Targretin, 75     mg/day) was safe and led to significant improvement on total PANSS scores, general     psychopathology, on the positive and the dysphoric mood factor scores. The aim of the present     study was to provide further insight into the safety and efficacy of bexarotene in comparison     to fenretinide (a medication with smaller potential of adverse effects) and placebo in     patients suffered from schizophrenia.   "
205709|NCT00534911|"     Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive     symptoms and more trouble with daily functioning than those without physical illness. The     proposed study will investigate if cognitive behavioral therapy (CBT) is better than     supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth     ages 9-17 with Crohn's disease or Ulcerative Colitis and depression. This study will also     assess the effect of CBT on IBD-related factors such as disease severity, medication     adherence, and physical-health related quality of life.      Hypothesis      - Individuals who receive CBT will show more improvement than individuals who receive SNDT.   "
205710|NCT00534924|"     Ischemic injury to muscular tissue is common in cardiovascular medicine. The most effective     treatment to avoid ischemic damage is the rapid re-establishment of reperfusion. However,     reperfusion itself can result in additional damage to ischemic tissue. This phenomenon is     called ischemia - reperfusion (IR) injury and is caused by different pathologic mechanisms.      Therapies are required which can be administered after the onset of an ischemic event to     protect the tissue against IR injury. Therefore, a promising strategy to reduce IR injury is     post-conditioning.      Likewise, pharmacological therapies administered after the onset of reperfusion might prevent     tissue injury. We have recently shown that high concentrations of exogenous vitamin C     abrogate experimental IR injury of the forearm vasculature in patients with peripheral artery     disease and in healthy subjects.      Study hypothesis      We hypothesize that the administration of mechanical post-conditioning or of high-dose     vitamin C may protect skeletal muscle against IR injury. This shall be studied employing MR     spectroscopy of the leg, which is an established model to assess muscle aerobic energy     metabolism.      Design      Three periods, three way cross over study in 10 volunteers. One screening visit, three     one-day study days with two washout periods of >3 days in between are scheduled for each     participant. The order of experimental days will be randomized. After the last treatment a     final follow-up examination will be performed within one week.   "
205711|NCT00534937|"     The researchers hypothesize that utilization of the Flexitouch system will improve the     healing rates of (venous stasis ulcers) VSU compared to traditional compression wrapping     therapy alone.      Primary Objective: The primary study objective is to determine whether the complete healing     rate of venous stasis ulcers at 12 weeks is improved by the addition of Flexitouch® System     compression therapy to a standard regimen of compression wrapping.      Secondary Objectives:        -  To determine whether the addition of Flexitouch System compression therapy to a standard          regimen of compression wrapping increases the percentage reduction in wound surface          area.        -  To determine whether the addition of Flexitouch compression therapy to a standard          regimen of compression wrapping increases the percentage reduction in volume of the          affected limb.        -  To determine whether the addition of Flexitouch compression therapy to a standard          regimen of compression wrapping decreases the time to healing of the venous stasis          ulcer.   "
205712|NCT00534950|"     Randomized multicenter study of 5 vs 6 weekly fraction of RT in the treatment of SCC of the     head and neck   "
205713|NCT00534963|"     The primary objective of this investigation was to evaluate if the location of placement of     the SIS balloon into either the uterine cavity or the cervical canal affected discomfort     perceived during the examination.   "
205714|NCT00534976|"     This study will see if there is a change in breathing after exercising when the child     receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer     before exercising and measured again several times after exercising.   "
205715|NCT00534989|"     Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous     Stem Cell Transplantation in Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease   "
205716|NCT00535002|"     Stress and cues reminiscent of cocaine use promote craving and relapse in cocaine dependent     individuals. In addition, there appears to be gender differences in determinants of relapse     to drug use following abstinence in cocaine-dependent individuals. Therefore the purpose of     the present study is to study the role of hormonal status on the response to cocaine-related     cues with or without stress in cocaine-dependent women and men.   "
205717|NCT00535015|"     The purpose of this study is to determine whether Betamarc is effective in improving the     appetite and reversing weight loss in patients with advanced Non-Small Cell Lung Cancer.   "
205718|NCT00535028|"     This is a single center, double-blind, randomised parallel group design study to investigate     the effects of AER 001 on the late phase asthmatic resonse in asthmatic subjects. AER 001 is     to be administered subcutaneously (25 mg, once daily) for 28 days. The asthmatic subjects     will be challenged with allergen both before and after AER 001 treatment (at screen and at     Day 28). The primary outcome will be late phase sthmatic response (the max drop in FEV1 from     4-10 hours after an allergen challenge).   "
205721|NCT00535067|"     The objectives of this study are to: 1) describe the prevalence of neuropathic pain (NP) in     breast cancer survivors and 2) to develop preliminary statistical risk models for predicting     the risk for NP incorporating disease-related variables (e.g., stage of disease, location of     tumor), treatment variables (chemotherapy, dose, duration; and other cancer therapy),     clinical health status (e.g., comorbid conditions), and sociodemographic characteristics     (e.g., age, sex, race).      Researchers will also gather data to answer the following secondary aims:        1. To assess the impact of NP on quality of life.        2. To assess the current management of NP in cancer (current medication, duration of such          treatment, reasons for discontinuation) and the outcomes of this management.   "
205722|NCT00535080|"     The aim of this study is to provide this investigational drug to patients who cannot be     optimally treated with conventional therapies and to collect efficacy and safety data on the     use of Metvix PDT in subjects with field actinic keratoses, large/multiple superficial basal     cell carcinomas (BCCs) or Bowen's disease.   "
205723|NCT00535093|"     There is a large over-use of antibiotics in family medicine, especially in upper respiratory     tract infections.      This study is designed to determine if the use of rapid Streptococcal tests in primary care     clinics can lower the rate of antibiotic use while not missing bacterial infections.   "
205724|NCT00535106|"     This study is designed to examine the impact of an available technology within an automated     external defibrillator (AEDs) to improve survival following out-of-hospital cardiac arrest     for patients presenting in ventricular fibrillation.   "
205725|NCT00535119|"     This phase I trial is studying the side effects and best dose of veliparib when given     together with carboplatin and paclitaxel in treating patients with advanced solid cancer.     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving veliparib together with carboplatin and paclitaxel may help kill more tumor     cells.   "
205726|NCT00535132|"     The purpose of this study is to evaluate medication satisfaction after at least 4 weeks of     paliperidone ER (extended-release), an antipsychotic, treatment in patients with     schizophrenia who were previously taking either 4 or 6 mg of risperidone daily by mouth, but     who are not satisfied with their treatment.   "
205727|NCT00535145|"     The purpose of this study is to evaluate the tolerability and safety of paliperidone ER     (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the     treatment of patients with schizophrenia or schizoaffective disorder and liver disease.   "
205728|NCT00535158|"     Vitamin D is necessary for healthy bones. Vitamin D is made in our skin when we are exposed     to sunlight, but it is also found in foods that we eat and in vitamin pills. Low levels of     vitamin D are common in many groups of people, because we do not get enough sun during the     winter and because we eat few foods that have vitamin D in them. Some foods with vitamin D     are salmon, mackerel, tuna, and fortified milk, which has had vitamin D added to it.      We know that nearly all kidney disease patients on dialysis do not have enough vitamin D in     their bodies. We believe this condition can cause muscle weakness, leading to falls and     broken bones. These are common problems for patients who are receiving dialysis. For example,     dialysis patients have a much higher risk of hip fractures (broken hips). However, no formal     research has been done on patients with low vitamin D levels receiving dialysis, to see if     they actually have muscle weakness and related problems.      There are two goals of this study. First, we want to see if patients on dialysis who have low     vitamin D levels are actually at risk for muscle weakness, muscle pain, and broken bones. We     also want to find out if giving vitamin D pills to these patients will result in better     muscle strength, less muscle pain, and fewer falls.      In this study, we will compare vitamin D to placebo. Placebo capsules look exactly like     vitamin D capsules but contain no active ingredients. We use placebos in research studies to     be sure that the study results are due to the study drug and not to other reasons.   "
205729|NCT00535171|"     To determine the effect of an interventional campaign run by a dedicated VTE Nurse Educator     over a 6-month period and the effect on prophylaxis rates.      To determine the proportion of medically admitted patients with risk factors for VTE.      To assess and compare the use of venous thromboembolism (VTE) prophylaxis in hospitalized     medical patients versus recommendations and current guidelines.      To determine the patient characteristics of those deemed to be at risk of VTE. To determine     the proportion of patients receiving appropriate thromboprophylaxis for their risk.      To determine the type and duration (where possible) of prophylaxis used.   "
205730|NCT00535184|"     Comparison of the ability of DBT and FFDM to detect breast cancer.   "
205731|NCT00535197|"     The aim of the study is to determine the safety and tolerability of an autologous CD34+     subset bone marrow stem cell infusion into the middle cerebral artery in patients who have     suffered acute total or partial anterior circulation syndrome (TACS/PACS).   "
205732|NCT00535210|"     This study would focus on adding a group exercise program to the usual therapy delivered in     the hospital. We propose to design an exercise program that would be 30 minutes in length, 3     times per week. A medical doctor and physiotherapist would oversee the design and monitoring     of the program.      We believe that this program will: 1) Increase the potential for better health, thus     improving independence and quality of life; 2) Help people make the move from therapist run     exercise to self management of exercise; 3) Engage the patient in the therapy process and     place an expectation of active participation on the client; and 4) Promote physical activity     as part of a healthy lifestyle.   "
205733|NCT00535223|"     The purpose of this randomized controlled trial is to determine if Group Based Exposure     Therapy (GBET) is more effective than treatment as usual in reducing the symptoms of     war-related Posttraumatic Stress Disorder (PTSD).   "
205734|NCT00535236|"     The proposed indication for the investigational heat-treated varicella-zoster virus (VZV)     vaccine is the prevention of herpes zoster (HZ) and HZ-related complications in     immunocompromised individuals.   "
205735|NCT00535262|"     This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a     selegiline transdermal system (STS), in bipolar depression.   "
205736|NCT00535275|"     Relapses after perioperative chemotherapy and surgery   "
205737|NCT00535288|"     To investigate efficacy and safety of 4 doses of esmirtazapine, compared to placebo, in the     treatment of moderate to severe hot flushes (vasomotor symptoms) associated with the     menopause. Co-primary efficacy endpoints are the frequency and severity of hot flushes after     4 and 12 weeks as compared to Baseline.   "
205738|NCT00535301|"     The purpose of this study is determine whether grafted anterior vaginal prolapse repair is     more effective and associated with less complications than prolapse repair with suture.   "
205739|NCT00535314|"     The primary purpose of the study is to determine the proportion of patients without     progression at 6-months in patients with unresectable Stage III or Stage IV melanoma who are     taking RTA 402.   "
205740|NCT00535327|"     Comparison of the ability of DBT and FFDM to detect breast cancer.   "
205741|NCT00535340|"     The primary objective of this study is to demonstrate the efficacy of SR58611A 350 mg twice a     day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as     assessed by the 14-item Hamilton Anxiety rating Scale (HAM-A).      Secondary objectives are to evaluate the tolerability and safety of SR58611A in elderly     patients with GAD, to evaluate the efficacy of SR58611A compared to placebo on disablility     and quality of life in elderly patients with GAD and to evaluate the tolerability and safety     of 24 weeks of additional treatment with SR58611A in elderly patients with GAD.   "
205742|NCT00535353|"     RATIONALE: AZD2281 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as irinotecan, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving AZD2281 together with irinotecan may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of AZD2281 and     irinotecan in treating patients with locally advanced or metastatic colorectal cancer.   "
205743|NCT00535366|"     This efficacy and safety study compares four different combinations of blinded inhaled     steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic     obstructive pulmonary disease (COPD). The primary objective is the effect on lung function     parameters.   "
205744|NCT00535379|"     Clinical Part:      The objective of this study is to determine the efficacy and safety of SUTENT in patients     with recurrent or progressive glioblastoma multiforme.Patients with tissue based diagnosis of     intracranial glioblastoma multiforme, above 18 years of age and of both genders, who have a     first tumor recurrence or progress after surgery, radiation- and chemotherapy will be     included. The hypothesis is that SUTENT will significantly increase the progression free     survival rate at 6 months in the study population.   "
205745|NCT00535392|"     Keppra injection is approved in the US as adjunctive therapy in the treatment of partial     onset seizures in adults with epilepsy. The objective of the current study is to assess the     safety, tolerability, and pharmacokinetics, of this formulation in children aged 4 to 16     years.   "
205746|NCT00535405|"     A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus     atorvastatin in elderly patients with high cholesterol at high or moderately high risk for     coronary heart disease.   "
205747|NCT00535418|"     This study will assess optimal duration of pre-operative treatment with letrozole and to     correlate clinical efficacy with appropriate surrogate markers.   "
205748|NCT00535431|"     This is a single centre, double-blind, randomised, parallel group, repeated dose asthmatic     subjects. Subjects will receive AER 001 (60 mgs) or placebo twice daily for 28 days. Before     and after treatment subjects will be experimentally challenged with inhaled allergen to     induce decreases in lung function. The primary outcome is late phase response to allergen as     measured by the average percent change in FEV1 from 4-10 hours following allergen. Because     AER 001 is a Th2 anti-inflammatory, it is hypothesized that AER 001 treatment will inhibit     the late phase response to allergen challenge.   "
205749|NCT00535444|"     Faith community nursing programs have grown out of churches as a response to the inequity of     healthcare delivery to uninsured and underinsured communities. These programs provide     outreach to community members and extend their services beyond just the parishioners of the     churches, reaching more uninsured people than traditional medical services. Although faith     community nursing programs have been established throughout the United States, no evaluation     of these programs has been done. QueensCare is taking the lead in measuring the effect of     parish nurses on health outcomes. In this project we have one specific aim: to measure the     effect of parish nurse visits on blood pressure control on community-dwelling hypertensive     patients. Our study will involve recruiting hypertensive patients from parish nurse led     health fairs and interviewing subjects at the time of recruitment. Patients will either be     randomized to parish nurse visits or primary care physician appointments. We will have a     4-month follow-up period with a re-check of blood pressures and an exit interview of the     patient. From this study, we hope to better understand if parish nurse visits improve blood     pressure and medication compliance among hypertensive patients.   "
205750|NCT00535457|"     It is not uncommon for children to undergo surgery. Surgery is a threatening event that is     composed of various stress-provoking stimuli. Pre-operative anxiety is a common emotional     response among operated children and their parents. In the current study we are going to     examine if tricks done by the anesthesiologist before anesthetic induction are equally as     effective as oral midazolam premedication in the reduction of pre-operative anxiety in     children before and after surgery. A successful anxiety reduction may be advantageous over     pharmacological premedication by cost reduction, a possibly shorter post anesthesia care stay     and by reducing postoperative maladaptive behavior rate.      Study hypothesis: 1. similar anxiety scores will be observed in children that will watch     their anesthesiologist performing tricks and in those who will receive oral midazolam     premedication but no tricks.      2. Similar rates of postoperative maladaptive behavior will be found in children that that     will see tricks and in those that will receive midazolam premedication.   "
205751|NCT00535470|"     To evaluate the efficacy and safety of topical application of MCH 0.04% in a propylene glycol     ointment (PG)in patients with stage I or IIA MF previously treated with MCH 0.02% in a PG or     AP ointment who did not achieve a complete response.   "
205879|NCT00543777|"     The goal of this clinical research study is to test the accuracy of magnetic resonance     elastogram (MRE) and 2-point dixon magnetic resonance imaging (2PD MRI) using new computer     software (called phase correction algorithm) in patients who might have liver disease.   "
205752|NCT00535483|"     The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients)     aims to develop a low-risk monitoring and control device which allows maintaining metabolic     control in intensive care units. A system will be developed comprising three subsystems: a     body interface for the delivery of biofluids, biosensors for the determination of glucose     concentration in these biofluids and an adaptive control algorithm that generates advice and     thus represents a decision support system with respect to insulin infusion rate to establish     glycaemic control in critically ill patients. Within a closed loop system, intensified     insulin treatment will make use of the calculations leading to external regulation of     glucose.      It is the aim of this study to evaluate the feasibility to establish glycaemic control in     type 1 diabetic subjects over a period of 30 hours by manually combining these three -     previously tested - subsystems (ABS System, extracorporeal online glucose sensor and a     laptop-based computer algorithm).   "
205753|NCT00535496|"     The objective of the trial is to determine the relationship within a participant between the     time to manual detection of the reappearance of the fourth twitch (T4) measured using a     peripheral nerve stimulator (PNS) and the time to recovery of the fourth twitch/first twitch     (T4/T1) ratio to 0.9 measured using a Train Of Four (TOF)-Watch® SX, of 4.0 mg/kg sugammadex     administered at 15 minutes after either a bolus dose of 0.6 mg/kg rocuronium or the last     maintenance dose of 0.15 mg/kg rocuronium.   "
205754|NCT00535509|"     Phase II trial of Neoadjuvant [FEC100]/Cisplatin-Docetaxel ± Trastuzumab in women with over     expressed or amplified Her2/Neu with Locally advanced Breast Cancer   "
205755|NCT00535522|"     The purpose of this study is to determine the safety and pharmacokinetics of TAK-285 in     patients with advanced cancer.   "
205756|NCT00535535|"     Dietary fructose potently exacerbates the dyslipidemia associated with obesity, insulin     resistance and accelerated atherosclerosis. In a randomized crossover outpatient study of 15     overweight adults, we will measure the increase over 4 hours in serum VLDL triglyceride     palmitate made by the liver from each single oral dose of fructose (0.5 g/kg),     fructose:glucose 1:1 (1 g/kg) or fructose:glucose 1:1 (2 g/kg). Our hypotheses are that the     synthesis of palmitate from dietary fructose will be 1) greater when consumed with glucose     and 2) show a dose-response. The lipogenic responses will be compared and correlated with     markers of carbohydrate and lipid flux measured after fasting and post-fructose. The results     will serve as a guide to the development of a new outpatient probe of the de novo lipogenic     pathway in subjects who vary in their lipogenic response to oral fructose. These studies     should ultimately yield valuable new information about the mechanisms linking dietary     carbohydrate to elevated triglycerides, diabetes and cardiovascular disease.   "
205757|NCT00535548|"     Aim of the study:      Evaluation of feasibility, safety and potential effects of stem cells on chronic wounds using     a pressure sore model.      Clinical relevance:        -  Accelerated healing of uncomplicated wounds        -  Enhanced healing of complicated (chronic, non-healing) wounds      Study design:        -  Prospective controlled phase I/II study        -  Cohort of 5 patients in pilot study, then reevaluation      Patients:      - Para- and tetraplegic patients with sacral pressure sores grade III-IVA according to the     classification of Daniel and Seiler      Methods:      1. First surgical intervention:        -  Radical debridement of pressure sore        -  Bone marrow harvest from the iliac crest        -  Isolation of hematopoietic stem cells, aiming to gain > 1 mio. CD 34+ cells per patient          under GMP conditions           3. Stem cell therapy (after 2 days)        -  Injection of stem cells in suspension (50'000 CD 34+ cells in 100 microliter saline per          cm2 of wound surface) on one half of the total wound surface and cell-free saline on the          other half as a control           4. Second surgical intervention (after 3-4 weeks):        -  Complete excision of the wound        -  Closure of the defect by fasciocutaneous flap           5. Evaluation of wound healing:        -  Clinical        -  3D laser imaging        -  Histology        -  Growth factor assay   "
205758|NCT00535561|"     To determine whether iron deficiency anemia can be an indication for the treatment of     subclinical hypothyroidism.   "
205759|NCT00535574|"     Background: Bexarotene (Targretin) is a synthetic retinoid mainly used for treatment of     patients suffer from oncological or dermatological diseases. The present study is based on:     evidence that retinoids are involved in neurodevelopment (the retinoid dysregulation     hypothesis); an assumption that the combined effect of antipsychotic agents and bexarotene     will have a beneficial effect on schizophrenia patients; and the positive findings from our     pilot open-label clinical trial (ClinicalTrials.gov Identifier: NCT00141947). However,     clinical efficacy of bexarotene should be investigated in a placebo-controlled trial.      Methods: In a 6-week, randomized, double-blind placebo-controlled trial Targretin (75 mg/day)     or placebo capsules will be added to the stable ongoing antipsychotic treatment of 90     schizophrenia patients. Participants will be assessed at baseline and after 2, 4 and 6 weeks     of treatment. A battery of research instruments will be used for assessment of     psychopathology, side effects, general functioning and quality of life. In addition,     cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count     will be monitored at baseline and during the study   "
205760|NCT00535587|"     The purpose of this trial was to test the combined and independent effects of 6 months of     exercise and Mestinon in people with fibromyalgia. Specifically, we wanted to determine if     Mestinon helped people with fibromyalgia have an easier time exercising and if their symptoms     improved by the end of the trial.   "
205777|NCT00535808|"     In a prospective and randomized study protocol, three different blood pressure regulating     agents (nitroprusside, nitroglycerine, sevoflurane) will be compared concerning their effect     on the cerebral oxygen balance between both hemispheres during aortic coarctation repair.     Cerebral and somatic saturation will be monitored non-invasively and continuously via optical     sensors applied to the right and left forehead and the somatic regions. Arterial blood     pressure, central venous pressure, heart rate and systemic saturation will be recorded     continuously. Intermittently, arterial and venous blood gas analysis will be performed at 6     definite time intervals. The study ends at the end of the operation.   "
205779|NCT00535834|"     RATIONALE: Studying samples of blood in the laboratory from patients before and after     treatment may help doctors learn more about the effects of the treatment on cells.      PURPOSE: This clinical trial is studying samples collected from patients with localized     prostate cancer who received treatment on clinical trial NCI-00-C-0154.   "
205761|NCT00535600|"     This study, conducted at the NIH Clinical Research Unit (CRU) at the Phoenix Indian Medical     Center, will compare the effects of two methods of bariatric surgery, the adjustable BAND and     Roux-en-Y gastric bypass, on insulin. Bariatric surgery is a treatment for achieving and     maintaining weight loss. The study will look at how this surgery might improve how insulin (a     hormone important for regulating blood sugar levels) is made and works in the body and the     possible role of changes in other hormones produced by the gut (stomach and intestines).      People between 18 and 50 years of age who are scheduled to have either laparoscopic     adjustable BAND or Roux-en-Y gastric bypass surgery may be eligible for this study.     Candidates are screened about 4 to 6 weeks before their surgery with a medical history, blood     tests and an oral glucose tolerance test for diabetes.      Participants spend 4 days at the CRU or 2 days overnight and an out-patient visit     approximately 4 to 6 weeks before their surgery and again 3 to 6 weeks after their surgery.     They return for a 4-6 hour visit at the CRU at 6 months, 1 and 2 years after surgery and for     half-day outpatient visits at 3, 4 and 5 years after surgery for the following procedures:        -  Blood and urine tests, including a pregnancy test for women. (4-day and 2-day admissions          and years, 3, 4 and 5)        -  DEXA, an x-ray scan to determine body fat content. (4-day and 2-day admissions and          years, 3, 4 and 5)        -  MRI scan to measure fat tissue in the abdomen. (4-day and 2-day admissions and years, 3,          4 and 5)        -  Intravenous (I.V.) glucose tolerance test for risk of obesity and diabetes. A sugar          solution is given through a needle in a vein of one arm and blood samples are drawn          through another needle in a vein in the other arm. (4-day admissions)        -  Meal test to measure blood sugar and insulin and gut hormone levels after a meal. After          an I.V. line is placed in an arm vein, the subject eats breakfast over 20 minutes. Blood          samples are collected halfway through the meal, at the end of the meal, and at 15, 30,          60, 90, 120 and 180 minutes after completing the meal. Subjects fill out questionnaires          on feelings of hunger and fullness before, during and after the meal test. (4-day and          2-day admissions)        -  Glucose clamp test to measure the effect on the body of insulin given through a vein. An          I.V line is placed in a vein in the arm and in a vein of the hand on the other side of          the body. While insulin is infused through one I.V., blood sugar levels are checked          every 5 minutes and a sugar solution is given into a vein as needed. A radioactive sugar          is also infused very slowly over 4 hours to determine how much sugar the body produces          by itself. (4-day admissions)   "
205762|NCT00535613|"     The purpose of the study is to see if a small dose of propofol given intravenously (through a     needle into a vein) at the end of anesthesia can make it less likely that children will be     agitated as the come out of the anesthetic.   "
205763|NCT00535626|"     The purpose of this study is to evaluate a hip implant system used when a previous hip     replacement surgery has failed.   "
205764|NCT00535639|"     This trial is performed to assess the tolerability of the ALK Tree Tablet in patients with     birch pollen induced allergy   "
205765|NCT00535652|"     The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue     from three hours up to six hours (25% of dosing interval) after administration of ertapenem.   "
205766|NCT00535665|"     A single center, randomized and double-blind phase II clinical trial is to be conducted in     adults to evaluate the safety and immunogenicity of an inactivated pandemic influenza vaccine     (whole-virion, aluminium-adjuvanted).   "
205767|NCT00535678|"     To compare DBT and FFDM for screening effectiveness in women who present for screening     mammography with respect to screening recall rate.   "
205768|NCT00535691|"     The purpose of this study is to estimate the systemic exposure to tacrolimus in infants with     atopic dermatitis after repeated application of tacrolimus ointment. Efficacy of tacrolimus     ointment, evaluated by examination of treated areas, will also be measured.   "
205769|NCT00535704|"     The Rural African American Families Health (RAAFH) Project is a federally funded research     study designed to evaluate the effectiveness two prevention programs designed for rural     African American families. One program, FUEL, helps teens develop lifestyles that prevent     health problems such as heart disease, diabetes, and being overweight. This program deals     with diet and exercise, the influence of TV and magazines on eating habits, and handling     stress. The second program, the Strong African American Families Teen Program (SAAF-T), helps     teens learn how to develop plans for the future and to avoid drug use and unsafe sex. The     sessions deal with goal setting, peer pressure, and staying in school.   "
205770|NCT00535717|"     Uttarbasti is per urethral administration of medicated oil which has been recommended by     Sushrut for urinary track disorders.      As far as conventional surgery is concerned urethral stricture still remains a challenge due     to post procedural high recurrences and complications      Uttarbasti being almost non invasive, with minimum recurrences and most economical, easy to     practice OPD procedure, can be the treatment of choice in the management of urethral     stricture.   "
205771|NCT00535730|"     The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal     Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given     together (in different body sites), as when they are given alone, in adults 60 years of age     and older.   "
205772|NCT00535743|"     The objective of the trial was to explore the dose-response relation of Org 25969 given as a     reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron®     (rocuronium) in subjects of ASA 1 to 3, and to evaluate the safety of single doses of Org     25969 administered to subjects of ASA 1 to 3.   "
205773|NCT00535756|"     This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term     safety data. During the long-term treatment with Creon 25000 nutritional parameters will be     assessed and correlated with CFA   "
205774|NCT00535769|"     The purpose of this study is to determine if using an electronic reminder improves adherence     to sunscreen use. The specific study aims are as follows:        1. To determine whether the use of electronic reminder system increases adherence to          topical agents.        2. To assess technological feasibility of measuring adherence to topical agents using          electronic monitors specially designed for tubes.        3. To assess technological feasibility of providing electronic reminders using cellular          phone text-messaging system.        4. To obtain subjects' feedback on the adherence monitoring and reminder system.   "
205775|NCT00535782|"     This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness,     and markers of atherogenic risk in patients with moderate to severe active rheumatoid     arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab     8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg     weekly. In Part 2, all patients will receive open-label treatment with tocilizumab plus     methotrexate.   "
205776|NCT00535795|"     Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment     of nasopharyngeal CA   "
205778|NCT00535821|"     Early intervention in the treatment of septic shock, including early goal-directed therapy     (EGDT) in the first 6 hours of disease presentation, has been shown to significantly decrease     mortality. However, this approach requires invasive hemodynamic monitoring, thus limiting its     widespread application in the emergency department setting. A minimally invasive protocol     utilizing esophageal Doppler monitoring (EDM) may be of benefit and practical if it is shown     to result in similar outcome as EGDT.   "
210951|NCT00604305|"     a comparison of two intraocular lenses in regard of accommodative power.   "
205780|NCT00535847|"     To provide access to a telaprevir-based treatment to subjects of the Control Group of Study     VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who     stopped treatment due to inadequate response to treatment. Safety, tolerability, and     Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.   "
205781|NCT00535860|"     The purpose of this study is to assess the clinical efficacy, safety, and tolerability of     ViaDerm-shPTH [1-34] transdermal delivery in comparison to subcutaneous injection of     rhPTH[1-34] following 3-month treatment in postmenopausal women with Osteoporosis   "
205782|NCT00535873|"     Primary Objective:        -  To assess the activity of lenalidomide in patients with previously untreated chronic          lymphocytic leukemia (CLL) age 65 and older.      Secondary Objective:        -  To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and          older   "
205783|NCT00535886|"     The purpose of this study is to test the effects of natural vs. man-made trans fatty acids     (trans fats) on blood cholesterol.   "
205784|NCT00535899|"     In patients with aortic stenosis and low ejection fraction, how can we predict who will     recover their ejection fraction after aortic valve replacement? We plan to observe 50     patients with Low EF aortic stenosis and perform serial echocardiograms pre and post-aortic     valve replacement and analyze regional wall motion contractility with a new software     application called speckle tracking imaging.   "
205785|NCT00535912|"     GOELAMS LLC98 is a prospective randomized trial comparing in previously untreated B and C     Binet stages B-CLL and on an intent to treat basis two strategies. Conventional chemotherapy     consisted of six monthly courses of CHOP, followed by 6 CHOP courses every other 3 months in     case of response. Experimental arm consisted of high dose therapy with autologous CD34+     purified progenitor cell support, used as consolidation of Complete Remission or Very Good     Partial Response obtained after 3 monthly courses of CHOP, followed by 3 to 6 monthly-courses     of fludarabine in case of insufficient response.   "
205786|NCT00535925|"     The NID-2 study, a multicentric study (21 centres enrolled), was planned in two phases:      Phase 1(observational study, completed at 2007): after the identification of a type-2     diabetic population with typical DN, to study of the rate of renal and cardiovascular events     during a middle term follow-up.      Phase 2(interventional study, started at 2007): after randomization in two groups, a group     (intervention group) is treated with an intensive multifactorial intervention whose aim is to     reduce morbidity and mortality due to diabetic complications. The other group (control group)     continues the conventional therapy . To avoid bias in the treatment in each center, the     randomization was performed for centre.   "
205787|NCT00535938|"     The MOBILITY Project is a prospective, non-randomized, observational, multi-centre evaluation     of Health Utility via the SF-12® Health Survey Scores and the SF-6D in patients receiving     BOTOX® for therapeutic use.   "
205788|NCT00535951|"     This study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6     substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication     in advanced stage NSCLC or malignant pleural mesothelioma patients   "
205789|NCT00535964|"     This study will determine whether there is a relationship between tobacco use and a     heightened response to panic-producing events among adolescents. This study is fundamental     research. It was not a Clinical Trial.   "
205790|NCT00535977|"     This is a parallel human intervention trial to determine to what extent a dietary     intervention of broccoli or peas can change the expression (switching on or off) of genes in     prostate tissue in men diagnosed with high-grade Prostate Intraepithelial Neoplasia (PIN).   "
205791|NCT00535990|"     The Minimally Invasive Surgery Team (MIST) are establishing a separate research database to     find out more about patient's undergoing minimally invasive surgery (laparoscopic , open and     robot assisted) procedures at UCSD. The hope is that collection of this information will give     physicians a better knowledge and understanding of the benefits of minimally invasive surgery     and possibly assist physicians to better manage future patients.   "
205792|NCT00536003|"     The administration of vaginal progesterone, in addition to standard tocolysis, will decrease     the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that     the reduction in preterm delivery will be associated with a decrease in infant mortality and     morbidity.   "
205793|NCT00536016|"     The purpose of this study is to determine the way and rate that the study medication, JSM6427     a potent, highly specific integrin α5β1-antagonist is absorbed, broken-down and eliminated     from the body when it is given as a single dosage strength by injection into the eye.     Repeated dosages will also be given to determine the highest safe dose.   "
205794|NCT00536029|"     Spectrophotometric intracutaneous analysis (SIAscopy) is a new technique for imaging     pigmented skin lesions and for diagnosing melanoma and non-melanoma skin cancer. The SIAscope     is a portable system comprising of a laptop computer connected to a small handheld skin probe     equipped with a light source. The skin lesion is interrogated with light of different     wavelengths and the reflection spectra analysed by proprietary algorithms showing     distribution, position and quantity of melanin, blood and collagen within the papillary     dermis (the SIAgraphs). Earlier studies generated promising results and documented >80%     specificity and sensitivity of SIAscopy for melanoma diagnosis. It has been suggested that     this technique could be used for the initial screening and selection of pigmented lesion for     excision. In this work we addressed the usefulness of SIAscopy for the clinical diagnosis of     pigmented malignant melanoma in a prospective, blinded design.   "
205795|NCT00536042|"     The tetracycline minocycline has, in addition to its anti-infective properties,     anti-inflammatory properties which may be of use in the treatment of asthma. This study     evaluates the benefit of minocycline as add-on therapy for adults with asthma.   "
205816|NCT00542048|"     The primary objective of study CT 4003 is to assess the behavior of EndoTAG®-1 in the body     (making a so-called pharmacokinetic profile). Therefore, the course of the drug in the body     is examined, i.e. the amount and speed of the drug uptake as well as the distribution and the     elimination of the drug is being investigated. Further objectives of the study are to assess     the effect of EndoTAG®-1 on liver metastases concerning size and blood supply measured by     imaging techniques (contrast-enhanced ultrasound and magnetic resonance imaging as well as     duplex sonography) and to assess the effect on blood markers which are indicators for the     destruction and neoplasm of blood vessels (so-called markers of angiogenesis).   "
205796|NCT00536055|"     The purpose of this study is to focus on dyadic coping as one of the main factors that     enhance resilience in adjustment to cancer, while also assessing other protective factors for     coping with traumatic events.      Specifically, the study aims are:        1. To assess the level of post traumatic distress, functional impairment and depression          among breast and prostate cancer patients and their spouses.        2. To assess resiliency factors such as flexibility, self efficacy and ego resilience among          breast and prostate cancer patients and their spouses.        3. To examine the pattern of dyadic coping at 3 time points: at the beginning and end of          radiation therapy, and at six-week follow-up.        4. To examine the relationships between dyadic coping and level of posttraumatic distress          and the resilience factors over time (in 3 repeated measures) Different aspects of          coping with the trauma of cancer and its treatment may be assessed. Measures of strength          and distress amongst patients and their spouses may enable a fuller picture of what          types of responses exist, which interventions may be most beneficial, and what other          factors may relate to positive coping, increased resilience and quality of life, such as          flexibility, and the nature of the couples' dyadic coping.   "
205797|NCT00536068|"     Nonsteroidal antiinflammatory drugs such as diclofenac or naproxen may interfere with the     inhibition of platelet aggregation by aspirin, because they all interact with the platelet     cyclooxygenase.This may be of great clinical importance because of an increased     cardiovascular event rate (myocardial infarction, stroke). The present randomized, controlled     study analyses in vitro platelet aggregation under a combined treatment of healthy volunteers     with aspirin and either acetaminophen, diclofenac, naproxen, or placebo.   "
205798|NCT00536081|"     The purpose of this study is to prevent chemotherapy-related febrile neutropenia, prophylaxis     with antibiotics and granulocyte colony-stimulating factor (G-CSF) have proven efficacious     [1-3]. G-CSF has only few side effects, but is expensive. In 2006, updated G-CSF guidelines     conclude that primary G-CSF prophylaxis has clinical benefits for and should be offered to     patients at a more than 20% risk of febrile neutropenia.      Based on many positive and few negative trials, one can consider the use of taxanes as     standard of care in the adjuvant setting in node-positive breast cancer. Taxanes (with or     without anthracyclines) have an increased risk for febrile neutropenia.      The updated guidelines and changes in daily clinical practice will have a significant impact     on the investigators health care resources. There is a higher risk of febrile neutropenia for     the first chemotherapy cycle compared to subsequent cycles in small cell lung cancer     patients. Also in advanced breast cancer the majority of first observed episodes of febrile     neutropenia occur in the initial chemotherapy cycles Irrespective of tumour type or     chemotherapy regimen, the risk of febrile neutropenia is highest during the first two cycles     of chemotherapy. Thereafter, the risk rapidly declines, and the benefit of G-CSF largely     seems to disappear.      So, in order to improve the cost-effective administration of primary G-CSF prophylaxis, it is     justified to assess whether G-CSF prophylaxis can be limited to the first two chemotherapy     cycles as compared to the current practice of continuous G-CSF prophylaxis.   "
205799|NCT00536094|"     This study will determine the effectiveness of a school-based cognitive behavior therapy in     urban, predominantly low-income, African-American children diagnosed with an anxiety     disorder.   "
205800|NCT00536107|"     This is a randomized, open- label, parallel group, phase IV, multicentre study. The total     number of patients expected to be recruited is 40. These randomized patients will have a     histologically or cytologically confirmed adenocarcinoma histology of locally advanced or     metastatic NSCLC. Patients will be recruited by investigational sites that have expertise in     treating patients with non-small cell lung cancer. The study will compare gefitinib     monotherapy 250 mg/day orally with docetaxel 60 mg/m2 intravenously over 1 hour every 3 weeks     with a primary endpoint of safety and tolerability. The target population will be patients     who have received one prior platinum-based chemotherapy and are now considered suitable     candidates for further chemotherapy with docetaxel. At study entry, patients will be     randomized on a 1:1 basis stratified with respect to performance status (0-1 vs. 2). Patients     may continue to receive treatment with either gefitinib or docetaxel until disease     progression, unacceptable toxicity or the occurrence of any of the other specific criteria.     An independent committee will be appointed to perform a blinded review of all patient scans.     Any assessments/visits after screening should be performed within a window of plus or minus 3     working days of the scheduled visit date. If selected screening evaluations are done within 7     days of Day 1, Cycle 1 of treatment, and are acceptable for study entry, they do not have to     be repeated on Day 1 unless the investigator believes that they are likely to have     significantly changed. Any patient who discontinues from study treatment without radiological     evidence of disease progression (except for withdrawal of consent by patient) should continue     to have objective tumor assessments every 6 weeks in order to collect information on     progression of disease   "
205801|NCT00536120|"     The primary objectives of this study were: to evaluate the effect of Tysabri® (natalizumab)     on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin [KLH])     and a recall antigen (tetanus toxoid [Td]), and to evaluate the effect of Tysabri on     circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) over time in participants     with relapsing forms of multiple sclerosis (MS). The secondary objective was to assess     alpha4-integrin saturation and alpha4-integrin expression levels over time.   "
205817|NCT00542061|"     The purpose of this study is to determine the clinical effectiveness and cost-effectiveness     of a written expert advice for GPs on additional diagnostic, treatment, and referral of     patients based on half-yearly monitoring routines for patients with COPD or ashtma with a     persistent obstruction in primary care based on a multicentre randomised nested clinical     trial   "
205818|NCT00542074|"     Randomized controlled trial (RCT) to evaluate the effectiveness of applying Purell® (62%     ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with BV for     preventing BV recurrence after treatment.   "
205819|NCT00542087|"     To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment     of osteoarthritis of the knee or hip during a six week period.   "
205820|NCT00542100|"     The aim of the clinical study is to evaluate the convenience and efficacy of the PCMRI in the     assessment of the prostate in humans.      The study cohort will include 50 patients and is designed to be non-comparative to other     diagnostic methods.   "
217432|NCT00699803|"     Study of T-PRED(TM) compared to Pred Forte(R)   "
205802|NCT00536133|"     Acute respiratory infections (ARIs) are the most frequent illnesses globally. Despite     advances in the recognition and management ARIs, these account for over 20% of all child     deaths globally.Trace mineral deficiencies have long been implicated in causation and     consequences of many diseases. The importance of adequate zinc intake in human health is well     documented and zinc deficiency is a large public health problem, especially among children in     developing countries.Various studies suggest that zinc-deficient populations are at increased     risk of developing diarrhoeal diseases, respiratory tract infections and growth     retardation.Among the individual interventions zinc supplementation with universal coverage     ranks 5th in preventing under five mortality in India, preceded only in order by breast     feeding; complementary feeding; clean delivery; Hib vaccination; and clean water, sanitation     and hygiene.Numerous studies have examined the association between child mortality and zinc     deficiency. A number of randomized controlled trials evaluating effect of zinc     supplementation have found the intervention to be beneficial in reducing ARI and diarrhoeal     mortality and morbidity but few studies have found beneficial effect in diarrhea and no or     even contrasting effects on morbidity pattern of acute respiratory infections. Whereas role     of zinc in diarrhea is now a well established and specific guidelines and recommendations     have been given for zinc supplementation in diarrhea, role of zinc in acute respiratory     infections is controversial. The contrasting effect of zinc on diarrhoea and acute lower     respiratory infection as reported in several studies is a public health concern, because zinc     supplementation is carried out in many nutrition rehabilitation units. Further in many of     randomized control trials supplement syrups also contained other vitamins, including vitamin     A, known to have effect on respiratory morbidity. Most of the trials evaluating effect of     zinc on respiratory morbidity and mortality are community based and children with well known     causes of recurrent acute lower respiratory infections have not been excluded from the study     pool.      Hence the current study was planned to bridge this gap of information and attempts to detect     the role of zinc using zinc only preparations in reducing respiratory morbidity in children     aged 6 to 59 months with recurrent acute lower respiratory infections.   "
205803|NCT00536146|"     This study, conducted at the University of Texas Southwestern Medical Center and the Parkland     Hospital in Dallas, will examine the stress hormone system of alcohol-dependent people. This     system is weakened in alcohol-addicted people. This study will determine how long it is     weakened, whether other hormone systems are also weakened and whether changes in the hormone     system are associated with previous trauma or stress.      Healthy normal men and men who are alcohol-dependent may be eligible for this study.     Candidates must be between 21 and 60 years of age and have at least a 5-year history of     active alcohol dependence. They are screened with a medical history, blood and urine tests     and questions about alcohol and drug use, psychiatric problems, history of trauma and recent     stress.      Participants undergo the following procedures:      Day 1 - Public Speaking Task      At 6:00 PM subjects have an I.V. line (needle attached to a small plastic tube) inserted into     a vein in each arm to draw blood samples and give medication. They are then given a light     dinner and then lie down and rest. They rinse their mouth out with water and a drop of lemon     juice is placed on their tongue. In 30 to 40 seconds they spit into a funnel attached to a     collecting tube. A blood sample is collected to measure levels of cortisol (a stress hormone)     ACTH (a hormone responsible for the release of cortisol) and neurosteroids (hormones that     affect the brain). Subjects then give a 5-minute speech (telling an ending to a story) and     solve a math problem in front of a small group of people. They are then asked how they are     feeling. Saliva and blood samples are then collected every 10 minutes for the next 60     minutes.      Day 2 - Cosyntropin Study      At 6:30 p.m. subjects have an I.V. line inserted into a vein in each arm. At 7:45 PM and 8:30     PM saliva is collected as described above. Starting at 7:30 PM, blood samples are collected     every 10 minutes until 9:00 PM and then every 20 minutes until 10:00 PM. At 8:00 PM     cosyntropin (a medicine that stimulates production of cortisol) is given through the I.V.     over 1 minute.      Day 3 - oCRH Study      At 6:30 p.m. subjects have an I.V. line inserted into a vein in each arm. At 7:45 PM and 8:30     PM saliva is collected as described above. Starting at 7:30 PM, blood samples are collected     every 10 minutes until 9:00 PM and then every 20 minutes until 10:00 PM. At 8:00 PM ovine CRH     (a medicine that stimulates production of cortisol) is given through the I.V. over 1 minute.      Participants may be asked to repeat these studies 3 months later.   "
205804|NCT00536159|"     Our objective was to test whether there were advantages to Nurse-CHW team home visiting     designed to combine the strengths of both visitors, with a focus on maternal stress and     mental health, when compared with standard of Community Care (CC) that included professional     home visitors in a state-sponsored Medicaid program. We conducted the study under usual     community conditions in a population of women eligible for state-sponsored Medicaid programs.     We predicted that during pregnancy and infancy, women in the Nurse-CHW team intervention     would report 1) less perceived stress; 2) fewer depressive symptoms; and 3) increased levels     of psychosocial resources (self-esteem, mastery, and social support) than women in CC.     Benefits were expected to be most pronounced for women with low psychosocial resources and     high stress at enrollment.   "
205805|NCT00536172|"     This study will evaluate the effectiveness of escitalopram to prevent depression in head and     neck cancer patients receiving treatment.   "
205806|NCT00541918|"     The aim of the study is to prove whether general anesthesia with inhaled sevoflurane reduces     the frequency of neurological and cognitive impairment after open-heart operations with use     of cardiopulmonary by-pass (CPB) in comparison with intravenous anesthesia with propofol.   "
205807|NCT00541931|"     We are seeking healthy female volunteers to determine if multinutrient supplementation     affects visible signs of skin aging as well as blood measurements of aging. We are seeking     smokers and non-smokers.   "
205808|NCT00541944|"     The prospective clinical diagnosis of hyponatremia is often very difficult- but requirement     for an appropriate and riskless treatment of hyponatremia. This study try to establish an     algorithm handling a prospective clinical categorization of hyponatremia and approving     together the start of an appropriate symptomatic therapy.   "
205809|NCT00541957|"     This is a pilot study. The purpose of this study is to determine whether adding 4 months of     behavioral therapy to primary care physician medication treatment(relative to medication     treatment alone) improves outcomes for persistently depressed primary care patients.   "
205810|NCT00541970|"     Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical     cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets     the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all     cervical cancers. In previous trials this vaccine has been found to be efficacious in the     prevention of incident and persistent HPV-16/18 infections and associated cytological     abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will     evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and     an alternative dosing when administered in healthy young females aged 9 to 25 years, as     compared to the standard HPV vaccine. The Protocol Posting has been updated in order to     comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following     a protocol amendment.   "
205811|NCT00541983|"     The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary     efficacy of XOMA 052 in subjects with active Type 2 Diabetes Mellitus (T2D).      IV administration of XOMA 052 is likely to improve glycemic control in subjects with T2D by     blocking certain receptors.   "
205812|NCT00541996|"     The purpose of this study is to determine the absorption rate of four oral formulations of     vabicaserin.   "
205813|NCT00542009|"     Study of whether the investigational drug CE-326,597 improves glucose control and results in     body weight loss in patients with type 2 diabetes   "
205814|NCT00542022|"     To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.   "
205815|NCT00542035|"     This is a Phase 2 study designed to test the ability of investigational study drug     ARRY-371797 to reduce pain either perioperatively or postoperatively in a third molar     extraction pain model, and to further evaluate the drug's safety. Approximately 150 subjects     from the US will be enrolled in this study.   "
205822|NCT00542126|"     Supraphysiological hormonal stimulation enables collecting many oocytes in an In-Vitro     Fertilization treatment, but may have a negative effect on uterine function and contribute     the fact that the majority of preembryos placed in the uterus fail to implant.      Several medical agents were shown to be beneficial when given in the luteal phase of an IVF     cycle, but the optimal regimen has not been yet determined. In 2006, a European group     reported that addition of GnRH analog (Decapeptyl) as luteal support in IVF cycle     significantly improved pregnancy and delivery rates. It is not known whether this positive     effect influences the corpus luteum, embryo or the uterus. The researchers sought to evaluate     the effect of GnRH administration as luteal support in frozen-thaws IVF cycle.   "
205823|NCT00542139|"     This study is performed to assess the influence of intraarticular injection of 2ml Diprospan     (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate) into     osteoarthritic knee in patients who undergo a total knee replacement of their contralateral     knee.      The study population will include 50 patients with bilateral knee osteoarthritis, admitted     for their first knee replacement surgery. Only patients with older than 50 years with primary     osteoarthritis will be included. The patients will be randomized into 2 groups. Intervention     group will receive an injection of 2ml Diprospan diluted in 10 ml Bupivocaine. The control     group will receive an injection of 10ml of Bupivocaine. All patients will be followed after 6     weeks and three functional rehabilitation and pain scores will be assessed (VAS pain score,     Timed Up and Go Score and Functional Ambulatory Category Scale).   "
205824|NCT00542152|"     PHASE: IV      TYPE OF STUDY: With direct benefit.      DESCRIPTIVE: Multicenter, randomized, open label study.      INCLUSION CRITERIA: Steroid-refractory ulcerative colitis.      OBJECTIVES: To compare the efficacy of cyclosporine with infliximab in steroid- refractory     attacks of ulcerative colitis.      STUDY TREATMENTS:Cyclosporine 2mg/kg/day intravenous(IV)for 7days then Neoral 4mg/kg/day     orally for 3 months. Infliximab 5mg/kg at Weeks 0, 2 and 6.      NUMBER OF PATIENTS: 50 patients in each group i.e. a total of 100 patients.      INCLUSION PERIOD: 24 months.      STUDY DURATION: 27 months.      MAIN EVALUATION CRITERIA:      Clinical response at D7 according to the Lichtiger Index score AND Clinical Remission at D98     according to the Mayo Disease Activity Index score      SECONDARY EVALUATION CRITERIA:      Clinical remission at D98 (according to the Mayo Disease Activity Index score) Endoscopic     response Colectomy rate Tolerance   "
205825|NCT00542165|"     To collect under daily practice conditions, clinical data on the changes of sexual function     when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with     lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy   "
205826|NCT00542178|"     Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can     cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes     (ACCORD) study is examining the effect of various treatments on cardiovascular disease in     people with diabetes. This current study will examine the effects of the ACCORD treatments on     the progression of DR in people participating in the ACCORD study.   "
205827|NCT00542191|"     This neoadjuvant chemotherapy protocol focusing on triple-negative breast cancers alone     will gather a foundation of primary tumor and axillary lymph nodal response to primary     chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome     data. This comparative data can then be used in building subsequent trials.   "
205828|NCT00542204|"     Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of     recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable     proportion of Americans with diabetes. To further reduce the treatment and adherence gaps in     diabetes care, the researchers propose to evaluate a Customized, Continuous Care Management     (CCCM) program that actively supports a partnership between the patient and his/her     multidisciplinary care management (CM) team using an online disease management (ODM) system,     which is integrated with a comprehensive electronic health record (EHR) system that includes     a personal health record and secure patient-clinician messaging capabilities. The CCCM     program builds upon CM strategies proven effective in past studies and creates an ODM system     that is built upon and fully integrated with a leading, commercially available EHR product -     providing a blueprint for instituting customized, continuous care management for many     different chronic conditions in a range of ambulatory care settings.   "
205829|NCT00542217|"     The purpose of this trial is to the assess the safety, pharmacodynamics, and pharmacokinetics     of escalating doses of Imprime PGG™ Injection in healthy volunteers.   "
205830|NCT00542230|"     This study will collect representative blood samples from healthy children and adults and     from children and adults who have unique red blood cell features that are related to sickle     cell disease. Sickle cell disease is a blood disease that limits the ability of red blood     cells to carry oxygen throughout the body. The purpose of the study is to collect a variety     of blood samples that may then be used to investigate advances and potential new drug     treatments for sickle cell disease.      Volunteers must be at least 8 years of old. Samples will be taken both from healthy     volunteers and from volunteers who have unique red blood cell features that are related to     sickle cell disease. Candidates will be screened with a medical history.      During the study, participants will undergo a one- to two-hour outpatient procedure at the     National Institutes of Health Clinical Center. Once researchers have explained the study and     obtained the participant s consent, participants will donate 8 cc (approximately 2 teaspoons)     of blood.      Because repeat testing helps researchers validate study findings, participants who have the     unique red blood cell features mentioned above may also be asked if they are willing to     return and donate another 2 cc to 8 cc of blood for additional studies. The amount of blood     drawn will not exceed 50 ml with any eight-week period for adults or 7 cc within any six-week     period for children.   "
205831|NCT00542243|"     The purpose of this study is to assess whether six months of daily finasteride (PROSCAR),     following an initial negative prostate biopsy, will improve the detection of prostate cancer     on repeat biopsy.      144 subjects with an initial negative prostate biopsy will be randomized to receive either     finasteride or placebo for 6 months. The subjects will undergo a second prostate biopsy     following drug intervention. PSA (prostate specific antigen) measurements, testosterone     levels, and quality of life questionnaires will also be assessed during the study. The two     groups will then be compared.   "
225875|NCT00809276|"     The purpose of this research is to find the most effective and least toxic way to prevent     GVHD after BMT.   "
205832|NCT00543140|"     The purpose of the study is to evaluate the long term safety of the Swedish Adjustable     Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed to     determine the re-operation rate (band revision, band replacement and explants resulting from     serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post implant.   "
205833|NCT00543153|"     The objectives of this study is to conduct a multicenter, dual country (United States and     Israel), study examining the experience of patients with cancer that were considered by their     physicians as having exceptional course of survival related to their specific disease state.      The primary aim of the study is to develop a detailed description of patients' experience of     an exceptional disease course. The secondary aim is to define the content domain for     assessment and measurement of exceptional disease course in patients with cancer and identify     lessons learned from these exceptional patients that can be a base for future studies to     benefit others.   "
205834|NCT00543166|"     Our research contributes to the understanding of some of the basic biology of the salivary     glands. The etiology and many of the pathomechanisms of Sjögren's syndrome are unknown. In     particular, reasons for the female dominance, late age of onset, fatigue and the prominent     involvement of exocrine glands are unknown. We hypothesize, due to the disease     characteristics, that the primary target hit by the disease process is the secretory acinar     cell and that this cell is particularly damaged in women due to insufficient support,     normally provided by dehydroepiandrosterone and its intracrine processing.   "
205835|NCT00543179|"     Background Somatostatin and octreotide LAR (long-acting analogue) exert a number of     inhibitory effects: on gut hormones, but also on gastro-intestinal secretion and motility.      Somatostatin analogues are effective in preventing symptoms and signs of both early and late     dumping as demonstrated previously. However, octreotide LAR causes gastrointestinal side     effects and the injection solution is difficult to prepare. Recently, a new somatostatin     analogue with a prolonged release formulation, Lanreotide autogel (L-autogel), has become     available. It is a viscous aqueous gel, composed solely of water and lanreotide. Deep     subcutaneous administration may lead to increased treatment acceptance compared with     intramuscular depot preparations. It is more easy to prepare and is though to cause less     local side effects and technical problems than octreotide LAR. Recent studies have been done     to measure the efficacy and safety of L-autogel in acromegalic treated previously with     octreotide LAR. These studies showed that L-autogel is effective and well-tolerated in these     patients, with equivalent or better disease control and less gastrointestinal adverse events.     Until now, there is no data available on the effectivety of L-autogel in patients with a     dumping syndrome. Therefore, this study aims to establish the effectiveness and tolerability     of L-autogel in patients with a dumping syndrome, previously treated with octreotide LAR.   "
205836|NCT00543192|"     The purpose of this study is estimate how sexual function in endometrial cancer survivors     varies with severity of disease.   "
205837|NCT00543205|"     This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects     will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic     function; n+8 and Cohort II (subjects with moderate hepatic impairment, Child-Pugh     classification Grade B; n=8). If, for any reason, the Genasense infusion is interrupted or     discontinued prior to completion or the rate of administration of the Genasense infusion is     changed, the subject will be replaced.   "
205838|NCT00543218|"     Compare in postmenopausal women with established osteoporosis the effect of treatment with     teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day     subcutaneous on change in lumbar spine BMD.   "
205839|NCT00543231|"     Genasense® is currently administered to subjects in clinical studies as a multiple-day     continuous intravenous infusion. Subjects are treated on an outpatient basis and carry a pump     that delivers the drug through a peripheral or central intravenous line. The route of     administration limits the convenience of treatment, and catheter-related complications have     been reported. This study is designed to evaluate the pharmacokinetics and safety of G3139     administered by subcutaneuous injection.   "
205840|NCT00543244|"     Hepatitis C virus (HCV) infection is a global health problem, which may lead to chronic     hepatitis, cirrhosis, hepatic decompensation and hepatocellular carcinoma (HCC). Recently,     treatment with peginterferon alfa plus ribavirin has become the standard of care for patients     with chronic hepatitis C. While genotype 2 patients can have higher sustained virologic     response (SVR) rates to 80-90%, genotype 1 patients generally have low SVR rates of only     40-50%. In contrast, genotype 1 Taiwanese patients have superior SVR rates than those in     Western countries. Despite the overall improved response to this combination therapy, more     than 75% of patients suffer from treatment-related adverse events and the costs remain high,     which make individualized therapy of paramount importance to maximize treatment response and     minimize adverse events.      HCV viral kinetics with interferon-based therapies have been studied recently to evaluate     patient responses. Early viral kinetics shown to have favorable SVR rates, which make shorter     treatment duration possible. However, different viral kinetics were found through ethnicity.     Recently, a pilot study to evaluate the viral kinetics of 6 Taiwanese patients with HCV     infection who received peginterferon alfa plus ribavirin therapy has shown superior early     viral kinetics to those in Caucasian patients. Based on the favorable SVR rates in treating     Taiwanese patients with chronic hepatitis C, the investigators aimed to conduct a large     confirmatory study to evaluate the viral kinetics and try to define the optimal treatment for     these patients.   "
205856|NCT00543465|"     This study will look at the incidence of gastric and/or duodenal ulcers in patients with     osteoarthritis or rheumatoid arthritis in four different treatment groups (a) MK0782 21 mg     plus enteric-coated aspirin, (b) MK0782 42 mg plus enteric-coated aspirin, (c) celecoxib 200     mg plus enteric-coated aspirin, and enteric-coated aspiring alone.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
205857|NCT00543478|"     Probiotics are friendly bacteria normally present in food products like yogurt whereas     irritable bowel syndrome is a longstanding functional disorder characterized by abdominal     pain and altered bowel habits either diarrhea or constipation dominant without a definitive     etiology.      Study Hypothesis:Does probiotics(Saccharomyces boulardii improves daily bowel symptoms and     quality of life in patients with diarrhea dominant irritable bowel syndrome?   "
205841|NCT00543257|"     Health literacy is an integral part of the pathway for the successful transfer of information     between patients and providers. Parents of children with Attention Deficit/ Hyperactivity     Disorder (ADHD) play an essential role in chronic care as they offer critical information to     providers that drives appropriate education and disease management. We propose the     development and evaluation of an electronic data entry tool that enables parents to     communicate data essential to treatment of their children, regardless of their own literacy     skills. The research plan addresses a question central to patient-centered information     management: how does health literacy influence parents' report of data on ADHD and the     process-level events that result from parent-provider communication? The following specific     aims organize the clinical study: proposal: 1) To assess the effect of health literacy on     successful completion of parent-reported ADHD health information in both paper-based and PCHR     formats, and, 2): To determine the association between health literacy and process-level     outcomes for ADHD that stem from parent-provider exchange of information. The formal     evaluation will study a diverse cohort of parents in a randomized trial of data entry (paper     versus PCHR) for ADHD-specific information. Primary care records for children of this cohort     will be analyzed for the prior 12 month period. Both a retrospective examination of     documented ADHD processes of care and a prospective evaluation of the utility of data from     the PCHR will occur. Literacy level is a primary variable of interest throughout the     evaluation.   "
205842|NCT00543270|"     Powerlink Bifurcated Infrarenal long-term follow-up study   "
205843|NCT00543296|"     The purpose of this study is to collect data on patients with severe uveitis that have     required re-implantation of the sustained-release fluocinolone drug delivery device due to     depletion of study drug in their previous implanted device.   "
205844|NCT00543309|"     The staged surgical pathway to treat children with single ventricle heart defects culminates     with the Fontan operation. In this procedure, systemic venous return is rerouted directly to     the pulmonary arteries, which serves to separate the systemic and pulmonary circulations.     Although mortality following the Fontan operation is now uncommon, early postoperative     morbidity including prolonged postoperative chest tube drainage and hospitalization remains     significant. The efficacy of empiric inotropic, vasodilator and neurohumoral-inhibitory     therapies in the perioperative period is unknown and practice varies widely between centers.      The investigators will propose a single-center, randomized, double-blind, phase II clinical     trial in children undergoing Fontan surgery. The investigators plan to compare the effects of     perioperative nesiritide, milrinone and placebo infusions on the early postoperative clinical     course and neurohumoral profile. The investigators hypothesize that, when compared to the     milrinone and placebo groups, the nesiritide group will have more days alive and out of the     hospital within the first 30 days after surgery.   "
205845|NCT00543322|"     The purpose of this study is to quantify the brain distribution of the nicotinic receptors in     human volunteers and their alterations in patients suffering from neurological diseases such     as Parkinson and Alzheimer diseases and familial epilepsy. This will be done using Postron     Emission Tomography (PET) and a new radiotracer of the nicotinic receptors.   "
205846|NCT00543335|"     The goal of this clinical research study is to find the highest safe dose of sorafenib that     can be given in combination with radiation therapy to people with lung cancer. The ability of     both the study drug and radiation to control the disease will also be studied.   "
205847|NCT00543348|"     The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC)     compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas.      2. SPECIFIC AIMS      Study endpoints will be:      Primary Endpoint      1. Primary and assisted patency at 6 months      Secondary Endpoints:        1. Procedure effectiveness/residual stenosis        2. Procedure-related complications        3. Primary patency and primary assisted patency 12 months        4. Secondary patency at 6 and 12 months        5. Number/type of secondary interventions.   "
205848|NCT00543361|"     The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering     blood glucose levels in patients whose Type II diabetes is not controlled by diet and     exercise.   "
205849|NCT00543374|"     Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in     CDAI of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of     initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these     cells to successfully re-induce clinical benefit.   "
205850|NCT00543387|"     This study will investigate the safety, side effects and how well the body tolerates MK-5108     as well as determine different doses of MK-5108 in participants with advanced and/or     refractory solid tumors.   "
205851|NCT00543400|"     The primary objective is to evaluate the safety and feasibility of using M118 as an     anticoagulant in the target population of subjects with stable coronary artery disease (CAD)     undergoing percutaneous coronary intervention (PCI).      The secondary objectives are to evaluate the effect of M118 on procedural indices including     procedure success, abrupt closure, post-procedure TIMI flow, and catheter thrombus.      Substudy Primary Objective The primary objective of the substudy is to characterize the     pharmacokinetic and pharmacodynamic profile of M118 among subjects with stable coronary     artery disease undergoing elective PCI.   "
205852|NCT00543413|"     This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood     pressure in patients who have hypertension (high blood pressure).   "
205853|NCT00543426|"     The primary purpose of the trial is adopted Fuzheng Huayu tablets against posthepatitic     cirrhosis, and to build a standard evaluation system for efficacy of traditional Chinese     medicine (TCM).      The second purpose is according to the international clinical guideline and the specialty of     TCM to build a standard clinical trial regulation for traditional Chinese medicine.   "
205854|NCT00543439|"     The purpose of this research study is to determine the effectiveness, safety, and     pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are     younger than 6 years of age, with severe or moderately severe hemophilia A.   "
205855|NCT00543452|"     Study of the effect of oxygen on the frequency of central apnea, sleep and body temperature     in patients with a cardiac disease   "
205878|NCT00543764|"     Efficiency in the operating room can be difficult in long cases with multiple surgeons. We     used a team based approach to develop an intraoperative pathway for microsurgical breast     reconstruction with a deep inferior epigastric perforator flap.   "
205858|NCT00543491|"     This study will assess MK0767's ability vs. placebo to control blood glucose in patients with     type 2 diabetes and to gauge whether fasting blood glucose is lowered, blood fats are     improved, and insulin levels are impacted.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
205859|NCT00543504|"     The goal of this clinical research study is to find the highest tolerable dose of Avastin™     that can be given in combination with 4 other study drug/drug combinations. It will be given     with sunitinib, with sorafenib, with a combination of erlotinib and cetuximab, and with a     combination of trastuzumab and lapatinib. The safety and effectiveness of these drug     combinations will also be studied.   "
205860|NCT00543517|"     The purpose of this study is to test if MK0767 lowers blood glucose after 20 weeks compared     to placebo.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
205861|NCT00543530|"     Monitor the safety and tolerability of efavirenz oral solution in combination with     Antiretroviral Therapy for the treatment of patients age 3 to 16 years who have failed     therapy or who are intolerant to their current therapy.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
205862|NCT00543543|"     The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in     comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered     to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503     reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease     compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type     6/11/16/18 antibodies compared with GARDASIL.   "
205863|NCT00543556|"     This is a clinical trial in patients with Type 2 Diabetes to test the safety of MK0767. This     study will also see how effective MK0767 is in lowering markers of glucose metabolism and     improving the lipid profile and non-HDL cholesterol when compared with placebo and     pioglitazone.   "
205864|NCT00543569|"     A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.   "
205865|NCT00543582|"     The first part of the study is to evaluate and determine if three different forms of MGCD0103     (free base FB-MGCD0103, tartaric acid free base [TA-FB-MGCD0103], and dihydrobromide [2HBr]     salt formulation MGCD0103) have the same properties when given to patients with cancer. The     second part of the study is to determine whether MGCD0103 administered in combination with     azacitidine is effective and safe in treating subjects with relapsed or refractory Hodgkin's     lymphoma or non-Hodgkin's lymphoma (NHL) (follicular or diffuse large B-cell [DLBCL]).   "
205866|NCT00543595|"     This study will test the safety and effectiveness of MK0916 in patients with Type 2 Diabetes     Mellitus and Metabolic Syndrome.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
205867|NCT00543608|"     The purpose of this study is to compare the clinical cure rates of two dosing regimens of     iclaprim with vancomycin (every 12 hours [q12h]) in the treatment of patients with     hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or     health-care-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive     pathogens.   "
205868|NCT00543621|"     Study to evaluate the effectiveness of a structured intervention to improve diabetes control.   "
205869|NCT00543634|"     The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of     Premarin®/medroxyprogesterone (MPA).   "
205870|NCT00543647|"     The purpose of this study was to test the effect of fenofibrate treatment on glomerular     filtration rate (GFR), kidney hemodynamics and tubular function in middle-aged subjects with     normal kidney function to further investigate the increase in creatinine levels observed in     fenofibrate-treated subjects.   "
205871|NCT00543660|"     To evaluate the transplantation of a posterior corneal disc for the management of corneal     endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet     Stripping Automated Endothelial Keratoplasty (DSAEK).   "
205872|NCT00543673|"     To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental     formula or a control formula   "
205873|NCT00543686|"     Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate     responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in     correlation to presence of allergy, bronchial hyperreactivity (PD20), exhaled NO, excretion     of leukotrienes, response to RABA and laboratory parameters in patients with pre-school     asthma i.e. asthma phenotypes.   "
205874|NCT00543712|"     This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and     safety of PRO95780 when given as a single agent in patients with advanced chondrosarcoma. Up     to 90 patients with confirmed chondrosarcoma will be enrolled.   "
205875|NCT00543725|"     The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278     given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily,     when combined with a background regimen containing 2 nucleoside/nucleotide reverse     transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1     infected patients who have not yet taken any anti-HIV drugs. The following evaluations will     be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution,     relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource     utilization and treatment adherence.   "
205876|NCT00543738|"     A study to test the effects of MK0767 when added to Metformin in patients with inadequately     controlled Type 2 Diabetes Mellitus.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
205877|NCT00543751|"     The purpose of this study is to compare how MK0767 and metformin and sulfonylurea therapy     lower blood glucose in patients with inadequate glycemic control This is an early phase trial     and some specific protocol information is in progress and not publicly available at this     time. (Full information is available to trial participants).   "
221402|NCT00751049|"     Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure   "
205880|NCT00543790|"     This is the first multiple-dose study in humans with PRA-027. This study will provide an     assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed,     metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is     active in the body) of PRA-027 after administration of 28 days of oral doses in women of     childbearing potential (cycling) or postmenopausal women.   "
205881|NCT00543803|"     This observational study is supposed to assess (under conditions of clinical practice in     daily routine) whether treatment with Viramune (nevirapine) in combination with Truvada     (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection     or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved     under previous anti-retroviral combination therapy after switch to combination treatment of     Viramune (nevirapine) and Truvada (tenofovir and emtricitabine).   "
205882|NCT00543816|"     This study will look to see if MK0767 works better than placebo in controlling blood sugar in     patients with Type 2 Diabetes who are taking insulin but do not have adequate control of     their blood sugar.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
205883|NCT00543829|"     The primary objective of this trial is to determine the rate of pathologically complete     remissions following a preoperative dose-intensified therapy with doxorubicin and docetaxel     with or without tamoxifen in patients with operable carcinoma of the breast. Secondary aims     are to assess the rate of clinical complete and partial responses, of breast-conserving     operations, and the toxicity of chemotherapy with and without tamoxifen.      Women meeting the following criteria will be eligible for the study: operable breast cancer     (T³3cm N0-2 M0), histologically confirmed diagnosis by core-cut needle or incisional biopsy,     and measurable disease by mammography or sonography or breast MRI (best appropriate method     has to chosen by investigator). After the patients have given written informed consent, they     will be randomised to the study treatments. All patients are scheduled to receive 4 cycles of     combination chemotherapy consisting of doxorubicin 50 mg/m² (15-min i.v. infusion) and     docetaxel 75 mg/m² (1-h i.v. infusion). The patients allocated to group I additionally     receive oral doses of tamoxifen 30 mg once daily, starting on the first day of chemotherapy,     while chemotherapy alone is administered to patients of group II. Cycles should be repeated     every 14 days, followed by surgery 8 weeks after initiation of the trial. Surgery consists of     removal of the remaining tumour (breastconserving resection or mastectomy) and axillary     dissection. Patients with no response or even progression of the primary tumour can be     treated to the discretion of the investigator but should be followed up according to     protocol. If a partial or complete tumour response has been achieved, radiotherapy is given     to the remaining breast in patients undergoing breast conserving therapy, and tamoxifen     treatment is continued for a further 5 years.      Response will be assessed between the 4th cycle and surgery, using the best appropriate     method. Clinical evaluation should be performed after each cycle. It is planned to recruite     200 patients during a period of 1 year.   "
205884|NCT00543842|"     The goal of this clinical research study is to find the highest tolerable dose of bevacizumab     (Avastin) and erlotinib hydrochloride (Tarceva) that can be given in combination with     standard radiation therapy and capecitabine before surgery to patients with rectal cancer.     The safety and effectiveness of this combination of therapies will also be studied.      The goal of this Phase I trial was to determine the maximal tolerated dose (MTD) of     concurrent capecitabine, bevacizumab and erlotinib with preoperative radiation therapy (RT)     for rectal cancer. The trial completed as Phase I without progressing to the Phase II     portion.   "
205885|NCT00543855|"     The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with     Dementia with Lewy Bodies (DLB).   "
205886|NCT00543868|"     This study will determine how if MK0782 is safe and tolerable and to determine how often and     the severity of stomach and small intestine ulcers develop following administration of MK0782     plus enteric coated aspirin, rofecoxib 25mg plus enteric coated aspirin, naproxen 500 mg puls     enteric coated asprin vs placebo.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
205887|NCT00543881|"     Superiority of additional Remote Patient Monitoring in patients with CHF In comparison to     usual care in terms of:        -  reduction of mortality rate        -  reduction of hospitalizations        -  increasement of patients' quality of life   "
205888|NCT00543894|"     Antibiotic Therapy for Hospital-Acquired Infections in ICU Patients. A prospective,     observational, multicenter study (ANTHICUS).   "
205889|NCT00543907|"     The purpose of this study is to analyze an institution's experience with starting a     subspecialized DIEP flap program.   "
205890|NCT00543920|"     The study will look at the effect of MK0777on reducing anxiety in subjects with general     anxiety disorder.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
205891|NCT00543933|"     Inhaled nitric oxide in patients with pulmonic valve insufficiency.   "
205892|NCT00543946|"     This is a study of GAP-134, an antiarrhythmic di-peptide. This study will provide an initial     assessment of the safety, tolerability, and pharmacokinetics (PK) of GAP-134 after     administration of ascending single intravenous (IV) doses to healthy Japanese male subjects.   "
205893|NCT00543959|"     A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients     with type 2 diabetes mellitus.   "
205894|NCT00543972|"     The primary objective is to determine the maximum tolerated dose of AVE9633 and to     characterize the dose limiting toxicity(ies). Secondary objectives are to determine the     anti-leukemia activity, the global safety and the PK profile.   "
205895|NCT00543985|"     We plan to test the hypothesis that patients with metabolic syndrome will have impaired left     ventricular diastolic parameters. These parameters will be measured before and after a stress     test at the end of a 3 month period of exercise training and a 10% weight loss.   "
205896|NCT00543998|"     This research project designed to diagnose sinusitis using a simple and low-cost optical     tool. Healthy sinuses are typically filled with air, and show up as bright spots on the     camera. Infected sinuses are filled with fluid and show up dark spots on the camera. Images     of infected sinuses could be used to diagnose sinusitis, or to check if surgical treatments     on the sinuses have been successful.   "
205911|NCT00544193|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together     with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when     given together with radiation therapy in treating patients with locally advanced upper     gastrointestinal cancer.   "
205897|NCT00544011|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     irinotecan, fluorouracil, and capecitabine, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving     bevacizumab together with combination chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well bevacizumab given together with combination     chemotherapy works in treating patients with metastatic colorectal cancer.   "
205898|NCT00544024|"     The objective of this study was to determine the bioequivalence among three commercial tablet     formulations of MQ, i.e. Lariam, Mephaquin, and Mefloquine-(AC Farma) when given in     combination with artesunate.   "
205899|NCT00544037|"     To assess the long-term effects of early therapeutic intervention, i.e. within two years     following a first clinical demyelinating event suggestive of MS.   "
205900|NCT00544050|"     The primary purpose of this study was to document the pharmacokinetic parameters of both     levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg of levetiracetam     in epileptic pediatric subjects, aged 1 month to less than 4 years.   "
205901|NCT00544063|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when     given together with irinotecan and oxaliplatin in treating patients with metastatic cancer.   "
205902|NCT00544076|"     RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone     prostatectomy for prostate cancer to recover from erectile dysfunction.      PURPOSE: This randomized clinical trial is studying giving sildenafil together with     alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical     prostatectomy for nonmetastatic prostate cancer.   "
205903|NCT00544089|"     To develop a biotechnological assay which will be able to recognize germ cells of the     spermatogenic lineand and to identify the chromosomal and morphological structure of mature     and immature male germ cells, in cases of of sperm production disorders(azoospermic     patients).      To recognize IL-18 in testicular tissue of azoospermic men compared to control group as it     has been suggested that this cytokine may serve as a paracrine defense factor in the male     gonad associated to spermatogenesis.   "
205904|NCT00544102|"     This study will test the effects of insulin resistance on atherosclerosis (hardening of the     arteries) in women who have systemic lupus erythematosus, more commonly known as lupus. Women     with lupus have a higher chance of developing atherosclerosis than the general population,     and as a result are more susceptible to heart attack and stroke. Insulin resistance is a     particular risk factor for atherosclerosis, and recent small studies have shown that insulin     resistance is more common in lupus patients than in those without lupus. The study will     consist of a series of tests designed to assess whether there is an association between     insulin resistance and atherosclerosis in women with lupus. This research may lead to further     studies on possible treatments to reduce the risk of heart disease in lupus patients.      Volunteers must be women between 30 and 55 years of age who were diagnosed with lupus within     five or more years prior to the study. Volunteers who have kidney failure, diabetes, or     existing atherosclerosis will be excluded from the study, as will volunteers who have had     pulse steroid therapy within four weeks of the testing or who have been pregnant within one     year of the testing.      Participants will undergo the following procedures on an outpatient basis:        -  Blood and urine tests for research purposes.        -  Electrocardiogram (EKG) to test the general health of the heart.        -  Oral glucose tolerance test to measure blood glucose and insulin levels. This test is          commonly used to diagnose diabetes and pre-diabetic insulin resistance.        -  Cardiac multidetector computed tomography (MDCT) to determine the amount of calcium          present in coronary arteries. This test is used to diagnose atherosclerosis.        -  Carotid artery ultrasound to show the speed of blood flow through the carotid arteries.          This test will show abnormalities and/or blockages in the carotid arteries.        -  Abdominal ultrasound to determine if the participant has hepatic steatosis ( fatty liver          ), which is often found in individuals with insulin resistance and diabetes.        -  Carotid artery magnetic resonance imaging/angiogram (MRI/MRA) to measure the thickness          of blood vessels. This test is used to diagnose atherosclerosis.        -  Abdominal MRI to estimate abdominal fat.      Volunteers may be asked to participate in an MRI/MRA study to evaluate the arteries of the     heart. This test is optional and not required by the insulin resistance/atherosclerosis     study. The entire series of procedures will require one to three visits to complete.   "
205905|NCT00544115|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell     transplant helps stop the growth of cancer or abnormal cells. It also helps stop the     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells     from a donor are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells     from a donor can make an immune response against the body's normal cells. Giving tacrolimus,     methotrexate, cyclosporine, mycophenolate mofetil, and sirolimus before and after transplant     may stop this from happening.      PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works     in treating patients with advanced hematologic cancer or other disorders.   "
205906|NCT00544128|"     A non-inferiority randomized control trial in treatment naïve HIV patients to compare     virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada     (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir     boosted atazanavir as key drugs.   "
205907|NCT00544141|"     The purpose of this clinical study is to evaluate the performance of the COL thermometer by     comparing its measurement to equilibrium measurement and to make a final tuning of the     thermometer algorithm.   "
205908|NCT00544154|"     The main purpose of the study was to determine the efficacy of CDP870 in treating RA     signs/symptoms in patients who were partial responders to MTX. Other purposes were to show     additional efficacy without increased toxicity and the immunogenic response to CDP870 during     combined CDP870 and MTX therapy.   "
205909|NCT00544167|"     Sorafenib is being looked at in a number of solid tumor settings including breast cancer.     This trial is designed as a pilot study to assess the safety and tolerability of a novel oral     agent in combination with standard chemotherapy in the treatment of early stage node positive     or otherwise high-risk breast cancer. If this should prove to be a tolerable regimen for     patients, this would provide rationale for further studies in a larger randomized fashion.   "
205910|NCT00544180|"     To determine the satisfaction of subject with Actonel 35 mg Once a Week in the treatment of     post-menopausal osteoporosis. Open, non-controlled, multi-center study.   "
205912|NCT00544206|"     To compare the glucose response in tube fed subjects with type 2 diabetes of a standard     enteral product to that of a diabetes-specific enteral product   "
206273|NCT00548002|"     To study whether fluoroquinolone (trovafloxacin or levofloxacin), added to standard     treatment, could reduce the high mortality and complication rates in Staphylococcus aureus     bacteremia.   "
205913|NCT00544219|"     RATIONALE: Studying PET scans given to patients with cancer who are undergoing treatment may     help doctors predict how patients will respond to treatment.      PURPOSE: This clinical trial is studying PET scans in patients with diffuse large B-cell     lymphoma who are receiving rituximab together with cyclophosphamide, doxorubicin,     vincristine, and prednisone.   "
205914|NCT00544232|"     The present clinical trial will investigate the efficacy of a sequential interval-shortened     and dose-intensified preoperative use of epirubicin, paclitaxel and CMF with preoperative     sequential administration of epirubicin and cyclophosphamide followed by paclitaxel in breast     cancer. In addition, the influence of darbepoetin alfa on the response rate and quality of     life is to be investigated in both treatment arms.   "
205915|NCT00544245|"     This study is comparing the effectiveness of two techniques for monitoring physical activity     and energy balance on long-term weight management (two years). The focus is on weight loss,     prevention of weight gain, and the maintenance of a healthy weight over time. It is expected     that both techniques will benefit long-term weight management.   "
205916|NCT00544258|"     The purpose of this study is to determine the extent of systemic absorption of PEP005 when     applied topically for the treatment of actinic keratoses.   "
205917|NCT00544271|"     To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK     Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months     old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for     the two DTP vaccines and single blinded for the control arm.   "
205918|NCT00544284|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as temozolomide, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving bortezomib together with     temozolomide may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     given together with temozolomide in treating patients with brain tumors or other solid tumors     that have not responded to treatment.   "
205919|NCT00544297|"     The purpose of this study is to examine the safety and toleration of PEP005 Topical Gel,     administered on an actinic keratosis (AK) treatment area on the top of a hand.   "
205920|NCT00544310|"     The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA)     kit, Adhexil™ in preventing and/or reducing post-operative adhesions in patients undergoing     surgery involving the ovaries.   "
205921|NCT00544323|"     comparison of alveolar bone resorbtion/ changes for a period of 12 month post loading of     different designs and brands of oral implants. in this study, a comparison between straumann     SLA-active implants to MIS Mistral and Mistral -X implants.   "
205922|NCT00544336|"     RATIONALE: Developing a questionnaire that can be used to assess the quality of life among     people who have a family member with cancer may help the study of cancer in the future.      PURPOSE: This clinical trial is studying quality of life among families with a member who is     a cancer patient.   "
205923|NCT00544349|"     RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Giving more than     one drug (combination chemotherapy) and giving them together with cetuximab may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving leucovorin together with     fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal     cancer and liver metastases that cannot be removed by surgery.   "
205924|NCT00544362|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving fluorouracil and cisplatin together with cetuximab and     radiation therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and     cisplatin when given together with cetuximab and radiation therapy in treating patients with     esophageal cancer that can be removed by surgery.   "
205925|NCT00544375|"     The study quantified functional measures of red blood cell mass and oxygen in neonatal     tissues using a non-invasive optical technique: near infrared optical spectroscopy . The     study will determine the absolute concentrations of deoxygenated and oxygenated hemoglobin     and calculate the tissue hemoglobin saturation and total hemoglobin concentration in viv.     Near infrared optical spectroscopy technique use to assessing and defining tissue status in     the anemic state and the tissue's response to transfusions, as well as in monitoring     hemoglobin and hematocrit without pain or loss of blood.   "
205926|NCT00544388|"     Controlled conditions of the EEU allow a reliable assessment of the efficacy and a     determination of the action onset, action intensity and duration of effect of levocetirizine     and cetirizine in order to establish the relative efficacy of these two drugs available for     the treatment of SAR.   "
205949|NCT00544700|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving     bevacizumab as maintenance therapy is more effective than observation in treating patients     with colorectal cancer.      PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works in     treating patients who have undergone first-line therapy for metastatic colorectal cancer.   "
205950|NCT00544713|"     This study will evaluate the safety and efficacy of a new artificial tear for the treatment     of dry eye that may occur after LASIK surgery   "
206288|NCT00548210|"     The purpose of this research is to demonstrate effectivity of Dermatix in promoting     maturation of the scar, versus a control region that will be treated with an indifferent     cream.   "
205927|NCT00544401|"     Infertility is a common and distressful problem for many couples, with assisted reproductive     techniques (ART) such as IVF and ICSI, with slightly more than 34% pregnancies per cycle.     Acupuncture is an ancient Chinese treatment in which thin needles are inserted into various     points along the skin, harmonizing the body's energy. Acupuncture has been found to     increase pregnancy rates following IVF/ICSI treatments, and is believed to affect ovulation     and fertility through elevation of beta-endorphin release and GnRH secretion, as well as     reduced sympathetic response with increased blood flow to the uterus. The sympatho-inhibitory     properties and impact on beta-endorphin levels of acupuncture, as well as its efficacy in     treating depression, may be helpful in reducing stress among women undergoing fertility     treatments as well. Hypnosis is a mind-body technique which uses suggestions during a relaxed     state to promote healing. Hypnosis can also significantly reduce the sympathetic response,     and is believed to produce uterine relaxation and quiescence during embryo transfer (ET),     which may lead to a reduction in embryo displacement from the uterine cavity. No research has     been published on the use of hypnosis with acupuncture (hypnopuncture) in ART.      This is a pilot study to evaluate the effect of a combined regimen of hypnopuncture on     clinical pregnancy rates in women undergoing IVF/ICSI following two failed cycles. During the     initial pre-treatment meeting, participants who fulfill all inclusion criteria and none of     the exclusion criteria will undergo hypnotic induction, followed by suggestions for increased     uterine blood flow. On the day of embryo transfer, participants will be randomly divided into     either treatment or no-treatment groups. Treatment will consist of the insertion of     acupuncture needles into pre-determined points, to be followed by a hypnosis pre-recorded     hypnosis session, as described above. Patients in the control group will receive standard     care without hypnopuncture and those participants in this group who do not conceive following     the 3rd cycle will be treated with hypnopuncture during the 4th cycle, following ET. A total     of 100 women will be enrolled, 50 in each arm of the study.   "
205928|NCT00544414|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving combination     chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells.     Drugs such as gemcitabine and cisplatin may make tumor cells more sensitive to radiation     therapy. Giving combination chemotherapy before surgery or radiation therapy may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving chemotherapy followed by surgery,     chemotherapy, and radiation therapy works in treating patients with locally advanced head and     neck cancer.   "
205929|NCT00544427|"     The Optical Coherence Tomography is a minimally-invasive diagnostic tool in both the office     and operating room settings can identify sources of airway obstruction and effective surgical     interventions. The researcher can use Optical Coherence Tomography to image tissues of the     aero-digestive tract during surgical endoscopy in to the nose, oral cavity, larynx and ear in     an outpatient clinic setting.   "
205930|NCT00544440|"     The purpose of this study is to investigate the effect of abiraterone acetate on levels of     androgens and steroid metabolites in bone marrow plasma of patients with metastatic     castration-resistant prostate cancer (CRPC).   "
205931|NCT00544453|"     The main objectives of this proposal are as follows:      To assess the dynamic uptake and washout of 123-I MNI-308, a potential imaging biomarker for     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in     similarly aged Alzheimer's (AD) subjects and healthy controls      To perform blood metabolite characterization of 123-I MNI-308 in healthy and AD subjects to     determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-308 as a     single photon computed tomography (SPECT) brain imaging agent      Evaluate the test/retest reproducibility of 123-I MNI-308 and SPECT in AD subjects and     healthy control   "
205932|NCT00544466|"     RATIONALE: Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and HT     before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop     the patient's immune system from rejecting the donor's stem cells. When the healthy stem     cells from a donor are infused into the patient they may help the patient's bone marrow make     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted     cells from a donor can make an immune response against the body's normal cells. Giving HT     together with fludarabine phosphate and melphalan before a transplant may stop this from     happening.      PURPOSE: This clinical trial studies helical tomotherapy (HT), fludarabine phosphate, and     melphalan followed by donor stem cell transplant in treating patients with hematologic     malignancies.   "
205933|NCT00544479|"     Most pulmonologist request a routine chest-x-ray after bronchoscopy with transbronchial     biopasie to exclude pneumothorax. We published a study in CHEST showing that routine     chest-ray might not be necessary. We would like to conduct a propsective study to validate     the results of the CHEST-study. Before and after the procedure follwing information will be     collected: Age, Sex, Indication for procedure, number of biopsies and segment of biopsie,     Saturation, Physical examination, Symptoms suggestive of pneumothorax. If there is no     aggravation of the symptoms and/or physical examination after the procedure, as compared to     before, routine chest-x-ray will NOT be done. A phone will be made 24 to 48 hours following     the procedure to the patient.   "
205934|NCT00544492|"     A. Pain and other disadvantages of AV fistula cannulation can be limited by using the     so-called buttonhole technique.      B. Till present in our center catheters with cylindrical points are used for cannulation of     AV fistulas with the rope ladder technique. One can hypothesize that a catheter with a bevel     point might have some advantages such as a larger entrance area and less traumatic     cannulation. The latter may influence pain sensation of the patients.      The above background information gives rise to the following investigational questions:      A. Buttonhole vs rope ladder technique        1. Is pain sensation different when using buttonhole cannulation as compared to rope ladder          cannulation technique?           Hypothesis:           AV fistula cannulation by buttonhole technique causes less pain than cannulation by rope          ladder technique.        2. Is the level of anxiety different when using buttonhole cannulation as compared to rope          ladder cannulation technique?           Hypothesis:           AV fistula cannulation by buttonhole technique causes less anxiety than cannulation by          rope ladder technique.        3. Is bleeding time different when using buttonhole cannulation as compared to rope ladder          cannulation technique?           Hypothesis:           Bleeding time is shorter when using buttonhole technique versus rope ladder technique.        4. Is the number and severity of complications related to AV fistula cannulation different          between buttonhole and rope ladder technique?           Hypothesis:           When using the buttonhole technique for AV fistula cannulation the number and severity          of complications is less than when using the rope ladder technique.           B. Rope ladder technique using catheters with cylindrical vs. bevel point        5. Is pain sensation different when using rope ladder cannulation catheters with          cylindrical as compared to bevel point?      Hypothesis:      AV fistula cannulation using bevel point catheters causes less pain than cannulation using     cylindrical point catheters.   "
205935|NCT00544505|"     Pre-operative chemotherapy in operable breast cancer, phase III study comparing a short     intensive pre-operative chemotherapy with the same therapy initiated shortly after surgery     (peri-operatively) (POCOB) (EORTC 10902)   "
205951|NCT00544726|"     Patients suffering from pulmonary arterial hypertension (PAH) frequently remain symptomatic     despite medical therapy. Symptoms include breathlessness, poor exercise capacity and reduced     quality of life.      In many other serious heart or lung diseases it has been shown that physical rehabilitation     improves patient's fitness and quality of life. In PAH there are no clear guidelines and in     general physical activity has traditionally been discouraged, although evidence for this     advice is lacking. Interesting research project in Germany showed significant benefit for     in-patient rehabilitation in PAH patients.      In this study we will perform a controlled clinical study of out-patient rehabilitation of     patients with PAH. We hypothesize that physical training of patients will result in increased     exercise capacity and improved quality of life.   "
221403|NCT00751062|"     PhXA41 is not inferior to timolol in reducing intra-ocular pressure   "
205936|NCT00544518|"     Objective--- Benfluorex may have effects on the glucose control in type 2 diabetes while it     improves hyperlipidemia. We sought to compare the impacts of benfluorex versus metformin on     glucose control and insulin secretion in Chinese type 2 diabetic patients.      Research design and methods—--a 16-week, double-blind, multiple centers, random parallel     controlled study is designed to compare the impact of benfluorex (150-450mg/day, provided by     Shandong Xinhua Pharmaceutical Company Limited in China) on glucose control, insulin     secretion and its safety with metformin in type 2 diabetic patients. 240 type 2 diabetic     patients are to be recruited to receive benfluorex or metformin(1:1). HbA1c, plasma lipid     level, insulin and glucose at 0', 30', 120' after a standard meal will be measured before and     after treatment, while fasting and postprandial glucose measured 4 times regularly. The     change of HbA1c from baseline to the end of treatment will taken as main efficacy criterion,     as the changes of fasting and after standard meal glucose and insulin level and plasma lipid     level will be taken as secondary criteria. All patient will be given safety monitor at prior     and post treatment. Data management and statistical analysis will adopt DAS for Clinical     Trial 2.0.   "
205937|NCT00544531|"     To examine the chromosomal number content in the blastomeres of embryos achieved from     fertilization of immature oocytes at MI stage recruited following COH for IVF.      comparison of the genetic number content of embryos and their quality in terms of cleavage     rate and morphological score reached after fertilization of immature oocytes at MI stage     whether arrested at the MI stage or extruded the polar body, after in vitro maturation for a     variable length of time.   "
205938|NCT00544544|"     Bipolar disorder is a common and often chronic and debilitating mental illness. The     depressive phase of bipolar disorder contributes the largest portion of the disorder, and     treatment resistant bipolar depression represents a significant public health problem. Recent     research has suggested that bipolar depression is associated with elevated brain glutamate     activity. We hypothesize that riluzole, a drug approved for ALS which inhibits glutamate     activity, will lead to clinical improvement in patients with bipolar depression.   "
205939|NCT00544557|"     This study aims to provide a holistic assessment of patients receiving etanercept in a     real-world setting.   "
205940|NCT00544570|"     RATIONALE: Giving high-dose chemotherapy before a peripheral blood stem cell transplant stops     the growth of cancer cells by stopping them from dividing or by killing them. Giving     colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the     blood so they can be collected and stored. The stem cells are then returned to the patient to     replace the blood-forming cells that were destroyed by high-dose chemotherapy and radiation     therapy.      PURPOSE: This clinical trial is studying the side effects and how well high-dose chemotherapy     works in treating patients undergoing stem cell transplant for recurrent or refractory     Hodgkin's lymphoma.   "
205941|NCT00544583|"     Patients undergoing primary midline laparotomy for an emergency surgical intervention with a     suspected septic focus in the abdominal cavity.   "
205942|NCT00544596|"     This phase I trial is studying the side effects and best dose of R-(-)-gossypol acetic acid     when given together with cisplatin and etoposide in treating patients with advanced solid     tumors or extensive stage small cell lung cancer. R-(-)-gossypol acetic acid may stop the     growth of cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as     cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving R-(-)-gossypol acetic acid     together with combination chemotherapy may help kill more tumor cells.   "
205943|NCT00544609|"     Safety profile and to determine maximum tolerated dose of Sorafenib in combination with     Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent   "
205944|NCT00544622|"     Background/Aim of the study: To further reduce the 6 months stroke morbidity and mortality in     a high volume stroke hospital and to compare the results with national and international     data.      Methods: 204 consecutive stroke patients are analyzed in a prospective study in a single     center teaching institution. The intervention consists of a structured therapeutic chain of     290 collaborating GPs, a standardised acute hospital proceeding overlapping with an early     integrated neurovascular rehabilitation within the same institution. Primary endpoints     include death and dependence at 6 months, secondary endpoints are the length of hospital stay     (LOS) and the quantitative analysis of physical and psychosocial impairments. The data are     directly compared with the same endpoints of the Swiss subgroup of the international stroke     trial (IST).   "
205945|NCT00544635|"     The goal of this project is to examine the ability of light exposure to improve the     appearance of cutaneous scars.   "
205946|NCT00544648|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Nab-paclitaxel (paclitaxel     albumin-stabilized nanoparticle formulation) may make tumor cells more sensitive to radiation     therapy. Giving nab-paclitaxel together with radiation therapy and carboplatin may kill more     tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving     nab-paclitaxel together with carboplatin and radiation therapy and to see how well it works     in treating patients with stage III non-small-cell lung cancer that cannot be removed by     surgery.   "
205947|NCT00544674|"     RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well PR-104 works in treating patients with     previously untreated or relapsed small cell lung cancer (SCLC).   "
205948|NCT00544687|"     CRx-191 is a proprietary synergistic combination drug candidate being evaluated by     CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening     assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor-     alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of     psoriasis.   "
205961|NCT00544869|"     To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral     administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated     administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient     (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume     expansion despite conventional diuretic therapy.   "
205952|NCT00544739|"     Cardiovascular risk in women is systematically underestimated by both - society and     physicians. Women younger than 50 years of age with acute coronary syndrome have 2x higher     mortality compared with age-matched men. A number of common vascular-disease-related     conditions are more frequent in women than in men. Women develop a more severe or different     form of vascular disease then men. Variability of onset, relative risk, and the synergy of     traditional and novel risk factors creates a challenge to physicians possibly resulting in     suboptimal management and disregard in women presenting with angina symptoms.      During last 10 years the rise in coronary artery disease (CAD) prevalence in younger women is     observed. Emerging data suggest a unique risk profile in women (hypoestrogenemia with adverse     effects of a protracted dysmetabolic state). The risk factors assessment and the risk factors     profiles in women that are associated with CAD may be different than in men and thus merit     reassessment.      Purpose The primary objective of this study is to determine characteristics and prognosis of     women with premature coronary artery disease and to evaluate the extent of atherosclerosis   "
205953|NCT00544752|"     The purpose of this study is to test whether different indoor temperature affect the     frequency of sleep apnea.   "
205954|NCT00544765|"     Primary objective of the study in patients without a sufficient sonographic response (i.e.     iNC) to 2 cycles of TAC as preoperative treatment of operable (T>/= 2cm, N0-2,M0) primary     breast cancer: To determine the response rate determined by sonography (iRR = iCR+iPR) of     further 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of     vinorelbine and capecitabine (NX) (TAC vs. NX)      Primary objective of the study in patients with a sufficient sonographic response (i.e. iRR =     iPR or iCR) to the first 2 cycles of TAC as preoperative treatment of operable (T>/=2cm,     N0-2,M0) primary breast cancer: To determine the pCR rate of 6 cycles vs. 8 cycles of     docetaxel, doxorubicin and cyclophosphamide (TAC x 6 vs. TAC x 8)   "
205955|NCT00544778|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and irinotecan, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Chemoprotective drugs, such as dexrazoxane, may protect normal     cells from the side effects of chemotherapy. Giving combination chemotherapy together with     dexrazoxane before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells     that remain after surgery.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with dexrazoxane followed by surgery and radiation therapy works in treating patients with     advanced soft tissue sarcoma or recurrent bone sarcoma.   "
205956|NCT00544791|"     Recent studies have described the role of melatonin as a sleep regulator and as an anti-     oxidative neuroprotective agent in improving sleep quality and delaying cognitive decline in     Alzheimer's disease (AD).      In accordance with this data, our hypothesis is that melatonin will delay the cognitive     decline in Mild Cognitive Impairment (MCI) patients and reduce the conversion rate from MCI     to AD.   "
205957|NCT00544804|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib in     treating patients with advanced or metastatic breast cancer that overexpresses HER2.   "
205958|NCT00544817|"     The mechanism of action of sorafenib makes it an interesting drug to investigate in the     treatment of patients with glioblastoma multiforme. Efficacy of agents with anti-angiogenic     activity has already been demonstrated and the PDGF receptor target may also be pertinent in     glioblastoma. The combination of temozolomide plus sorafenib has been investigated previously     in the treatment of patients with advanced melanoma. The combination was generally well     tolerated; in previously untreated patients, a standard dose of sorafenib (400mg PO bid) was     administered with temozolomide 150mg/m2 PO daily for 5 days, repeated every 28 days (23).      In this multicenter phase II study, patients with newly diagnosed glioblastoma will receive     standard treatment, including initial debulking surgical resection (if feasible) followed by     high-dose radiation therapy with concurrent temozolomide. After completion of radiation     therapy, patients will continue treatment with temozolomide (150mg/m2 days 1-5) and sorafenib     (400mg PO bid daily), repeated at 28-day intervals for 6 cycles.   "
205959|NCT00544830|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more     tumor cells and cause less damage to normal tissue. Androgens can cause the growth of     prostate cancer cells. Androgen deprivation therapy, such as goserelin, leuprolide, or     bicalutamide, may lessen the amount of androgens made by the body. Giving intensity-modulated     radiation therapy together with androgen deprivation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy works     in treating patients undergoing androgen deprivation therapy for metastatic prostate cancer.   "
205960|NCT00544856|"     A recent meta-analysis that included over 29.000 individuals found that the odds ratio (OR)     of individuals with high brain reserve compared to low was 0.54 (p < 0.0001), a risk decrease     of 46%. Among the factors that influence cognitive reserve, mentally stimulating activities     was the most robust factor after controlling for education, age, occupation and other     potential confounds. The brain reserve effect was sustained over a median longitudinal     follow-up of 7 years. It would be interesting to detect whether a complex cognitive training     could show similar effects on the cognitive abilities of patients with mild Alzheimer's     disease (AD) and mild cognitive impairment (MCI) as it has been reported in previous studies     based on mentally stimulating activities analysis.      The hypothesis is that a complex cognitive training alters the neural networks in both     subject groups and this alteration is associated with improvement or stabilization of     cognitive and non-cognitive function.      The investigator will perform a complex cognitive training program. Twenty patients with mild     AD and twenty four patients with MCI will be recruited in this study. The patients will be     randomised in control- and treatment groups.Additionally indirect effects on non-cognitive     functions will be evaluated in caregivers of the patients.      The investigators expect that the cognitive and non-cognitive abilities will be changed     during the cognitive training. The investigators also expect differences between treatment     and control groups.   "
205962|NCT00544882|"     This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen     DR-1021.   "
205963|NCT00544895|"     NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic     groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal     brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage     mainly observed in preterm newborns. (Copy from www.neobrain.eu)   "
205964|NCT00544908|"     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with     stage IV pancreatic cancer.   "
205965|NCT00544921|"     To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by     mouth.   "
205966|NCT00544934|"     A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple     dose levels of GLY-230 in healthy and diabetic subjects   "
205967|NCT00544947|"     Spinal Administration of opioids offers segmental analgesia, but has side effects including     pruritus, nausea and vomiting, urinary retention, hypotension, and respiratory depression,     both early and delayed. Many Centres in the UK now routinely use supplementation of spinal     anaesthesia from bupivacaine with intrathecal fentanyl or diamorphine. If Fentanyl is used,     this is usually accompanied by connection to a i.v. Morphine patient-controlled analgesia     (PCA)-device in the postoperative period, whereas the use of intrathecal diamorphine seems to     result in a reduction in post-operative morphine requirements, which has obviated the need     for PCA devices in many centres. There has been recent controversy over which opioid is safer     to use with regards to the risk of respiratory depression.1,2 The investigators want to     investigate, whether intrathecal diamorphine causes less or more post-operative respiratory     depression in healthy mothers undergoing elective caesarean section than intrathecal fentanyl     plus post-operative morphine PCA.   "
205968|NCT00544960|"     This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and     safety of AT-101 in combination with docetaxel in relapsed/refractory non-small cell lung     cancer   "
205969|NCT00544986|"     The overall objective of the clinical study is to assess the tolerability and clinical     efficacy of anastrozole in post-menopausal women with hormone sensitive advanced breast     cancer in India.   "
205970|NCT00544999|"     RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Everolimus may help cytarabine and daunorubicin work better by making cancer cells     more sensitive to chemotherapy. Giving everolimus together with cytarabine and daunorubicin     may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when     given together with cytarabine and daunorubicin in treating patients with relapsed acute     myeloid leukemia.   "
205971|NCT00545012|"     This long-term open label follow-up trial gave pediatric subjects suffering from typical     absences in CAE or JAE the opportunity to continue levetiracetam treatment after     participation in the pilot study (study N162) or the double-blind study (study N163). Safety     and efficacy data were obtained.   "
205972|NCT00545025|"     The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after     revaccination.   "
205973|NCT00545051|"     This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in     the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will     be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and     calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target     sample size is 100-500 individuals.   "
205974|NCT00545064|"     To evaluate if preservative free cosopt is well tolerated in patients with Open angle     glaucoma (OAG) or Ocular hypertension (OH) with dry eyes.   "
205975|NCT00545077|"     Locally advanced or metastatic breast cancer in postmenopausal women with negative HER2, who     are candidates for hormone treatment and who have not received previous chemotherapy or     hormonotherapy for the metastatic disease.      The main endpoint of the study is PFS. It has been calculated that 378 patients will need to     be included, according to the following assumptions:        -  Recruitment period of 21 months.        -  Minimum follow-up period of 9 months.        -  PFS of 9 months in the control arm (letrozole in monotherapy). Using a two-sided          log-rank test, for a 5% α level, 344 patients (172 in each treatment arm) will be          required for 270 events to occur, which will provide an 80% power for detecting a hazard          ratio of 0.69 (corresponding to a PFS median of 13 months in the bevacizumab arm). This          sample size has been adjusted for an intermediate analysis when 2/3 of the total of          required events have occurred. This intermediate analysis can be avoided if, at the time          in which it must be carried out, it is estimated that the final analysis will be carried          out in 4 months.      Taking into account a 10% percentage of losses, 378 patients are expected to be included in     the study.      An intermediate safety evaluation will be carried out when 63 patients have finished their     treatment in each treatment arm.   "
205976|NCT00545090|"     This single arm study will continue drug safety surveillance, and assessment of adherence, in     patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930,     the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive     Bonviva (150mg po, monthly) for an additional 6 months. The anticipated time on study     treatment is 3-12 months, and the target sample size is 500+ individuals.   "
205977|NCT00545103|"     The purpose of this study is to determine whether SPD476 is effective in reducing recurrence     of diverticulitis.   "
205978|NCT00545116|"     The primary objective of this clinical trial is to determine the effects of hesperidin on     biochemical markers of bone in post-menopausal women.      The secondary objectives are:        -  To investigate changes in bone formation and bone resorption markers in response to          hesperidin intake        -  To compare the efficacy of hesperidin in a milk versus biscuit        -  To collect safety information of hesperidin consumption in a human trial   "
205979|NCT00545129|"     The purpose of this study is to investigate the safety and efficacy of tanezumab in     combination with opioids in treating pain due to cancer that has spread to bone.   "
205980|NCT00545142|"     To demonstrate the efficacy and safety of co-administration of Abilify(aripiprazole) with     Depakote(divalproate) in the acute phase of 6-week treatment of acute mania in patients with     bipolar disorder.   "
205981|NCT00545155|"     The purpose of this study is to: 1) evaluate the reliability and validity of EMS screening     for depression and cognitive impairment and 2) to develop a pilot ED intervention program to     address the needs of older adults found to be at risk for depression and cognitive     impairment.   "
205982|NCT00545168|"     A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse,     under actual use conditions in subjects 6 months of age or greater who are infested with     Pediculosis capitis (Head lice).   "
205983|NCT00545181|"     Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations     in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of     adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal,     nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and     transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the     membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and     postpartum endometritis. Several studies have documented increased postpartum complications     in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite     common despite treatment. Documented recurrence rate of up to 30% within three months are     reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic     regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic     therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an     acidifying gel will decrease the chance of recurrence of BV within 3 months.   "
205984|NCT00545194|"     The aim of this study is to compare two different preparation   "
205985|NCT00545207|"     This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on     parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral     density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly,     and measurements will be taken at baseline, and at intervals over 2 years. The anticipated     time on study treatment is 2+ years, and the target sample size is 100-500 individuals.   "
205986|NCT00545220|"     Vision loss can result in feelings of frustration, helplessness, anxiety, depression, and     anger, which compromise a person's activities of everyday living. While emotional distress     may resolve in some persons without intervention, unmanaged and persistent distress places     the person at risk for continued decrements in health status and the potential development of     more severe conditions (i.e., depression, poor health outcomes). Persons with low vision will     be recruited and randomly assigned to either an innovative, problem-solving training (PST)     intervention group designed specifically for persons with low vision or a sham     intervention/control group. Primary and secondary outcomes will be assessed at baseline prior     to intervention and at 3 month follow-up, 7 month follow-up, 12 month follow-up, and 24 month     follow-up by a research interviewer masked to participants' randomization. This project will:     (1) demonstrate how specified physical and emotional outcomes of persons with low vision     change across time, (2) evaluate the effectiveness of a PST intervention that will be     delivered to persons with low vision; and (3) identify persons with low vision who are at     risk for adverse emotional and health outcomes.   "
205987|NCT00545233|"     This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without     concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with     genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to     receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body     weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily     for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day +     pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years,     and the target sample size is 100-500 individuals.   "
205988|NCT00545246|"     The primary objective of this study is to determine the dose of aflibercept to be further     studied in combination with docetaxel in Japanese cancer patients.      The secondary objectives of this study are to assess the safety profile of aflibercept, to     determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor     effects.   "
205989|NCT00545259|"     The study will evaluate the pharmacokinetic profile of AEB071 in the immediate     post-transplant period in patients who have undergone their first liver transplant.   "
205990|NCT00545272|"     This study will evaluate the dose response relationship among four doses of indacaterol as     well as placebo delivered via the TWISTHALER® device.   "
205991|NCT00545285|"     There are two distinct aims of this study:        1. This prospective study is designed to document the long-term (10-year) radiographic and          clinical outcomes of a new type of highly cross-linked polyethylene liner which contains          vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty          subjects. The clinical outcome of E-Poly will be compared to a group of subjects          receiving Arcom XL polyethylene.        2. This study is also designed to document the long-term (10-year) radiographic and          clinical outcomes of a new cementless acetabular component having a titanium porous          surface (Regenerex). The clinical outcome of this new FDA cleared device will be          compared a group of subjects receiving an acetabular component having a plasma sprayed          surface.   "
205992|NCT00545298|"     This study will test the safety and efficacy of nitric oxide gas in the treatment of venous     leg ulcers   "
205993|NCT00545311|"     This study will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses     of the NVA237 in mild and moderate COPD patients .   "
205994|NCT00545324|"     In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective     as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction     over a 6 week comparison period.   "
205995|NCT00545337|"     To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in     terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR     1964) in subjects with type I diabetes mellitus   "
206025|NCT00533000|"     The primary aim of this study is to evaluate the effect of preoperative smoking cessation on     postoperative complications among patients undergoing surgery. Secondary aims are to evaluate     effect on wound complications, short and long term effects including abstinence rate, pain,     quality of life and effects on the immune system.   "
227943|NCT00836017|"     This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in     treating Cervical Dystonia.   "
205996|NCT00545350|"     1. Primary objective: to evaluate the effectiveness of a fall prevention exercise program          in preventing falls resulting in fractures and other physical traumas.        2. Secondary objectives:             -  to better understand the mechanisms by which physical exercise prevents falls and               ensuing injuries (improvement in physical functional abilities, global physical               activity level, general physical and psychological wellbeing and self-confidence).             -  to determine the individual factors associated with long-term adherence to the               exercise program.   "
205997|NCT00545363|"     This 2 arm study will assess the impact of bone marker feedback (BMF), using serum     carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on     adherence to once monthly ibandronate (150 milligrams [mg] per oral [po]) in women with     post-menopausal osteoporosis supported by patient-relationship program (PRP). Participants     will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The     anticipated time on study treatment is 3-12 months.   "
205998|NCT00545376|"     There is a high prevalence of asthma in southwest Virginia and there are multiple osteopathic     manipulative techniques (OMT) which are thought to improve lung function. However, there are     inadequate studies regarding the effectiveness of using osteopathic manipulative treatment     (OMT) as an office treatment or a home treatment to address obstructive lung disease. In     addition, there is little information on the level of acceptance, use, and cost effectiveness     of using OMT in rural southwest Virginia. The purpose of this study is to determine the     viability of OMT treatment with asthma, the level of acceptance in selected clinics in     southwest Virginia, and the effectiveness of home OMT education in order to implement a     program to improve asthma control. The study hypotheses are: 1. Osteopathic manipulation     delivered to the asthmatic patient will significantly improve spirometry values, thoracic     excursion, and subjective asthma symptoms. (.05 alpha) 2.Patients who are taught and use a     home treatment regime for asthma will significantly improve spirometry values, thoracic     excursion, and subjective asthma symptoms after two weeks, compare with those who do not have     home treatment.      3.Physicians educated on the use of OMT for asthma will increase their perceived future use     of OMT as an adjunct to treat this disorder.   "
205999|NCT00545389|"     Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for     three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).   "
206000|NCT00545402|"     This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment     regimens in de novo liver transplant patients. Patients will be randomized into one of two     groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to     exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed     dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day     0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
206001|NCT00545415|"     The aim of the study is to compare the effect of consumption of a fruit beverage on plasma     antioxidant capacity with that of the consumption of fruit.   "
206002|NCT00545428|"     The purpose of this study is to evaluate the safety and efficacy of mastoid bone autograft     for dorsal nasal augmentation in rhinoplasty.   "
206003|NCT00545441|"     The purpose of this study is to determine whether the Surgisis anal fistula plug is just as     effective in healing anal fistulas as compared to the advancement flap procedure.   "
206004|NCT00545454|"     The primary objective of this study is to assess the reduction of systemic inflammation as     measured by serum levels of C-reactive protein (CRP).      The secondary objectives are:        -  to assess the reduction of systemic inflammation as measured changes in acute phase          protein, serum amyloid A (SAA) and cytokine interleukin-6 (IL-6), and clinical American          College of Rheumatology response rate, and morning stiffness duration;        -  to assess the effect on pain relief within first 14 days;        -  to obtain evidence of the safety and tolerability of SSR150106;        -  to document trough plasma levels of SSR150106 and its first metabolite.   "
206005|NCT00545467|"     The purpose of this study is to determine whether moderately ill Asian schizophrenic patients     can be switched from their previous antipsychotic medication to aripiprazole with minimal     adverse clinical consequences, and elucidate both pharmacokinetic and pharmacodynamic factors     associated with clinical efficacy of aripiprazole.   "
206006|NCT00545480|"     This 2 arm study will assess the impact of bone marker feedback, using blood sampling and     communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women     with post-menopausal osteoporosis. The study will also assess safety, quality of life and     patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be     randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study     treatment is 3-12 months, and the target sample size is 500+ individuals.   "
206007|NCT00545493|"     Rasmussen encephalitis (RE) is a rare but severe chronic inflammatory brain disease of     unknown origin affecting one brain hemisphere. It is usually accompanied by intractable     epilepsy. In addition, it often leads to severe disability due to functional deficits caused     by atrophy of one brain hemisphere. Hemispherectomy is an effective means of surgical     treatment of the epilepsy. It renders the patient, however, hemiplegic, hemianopic and (if     the language dominant hemisphere is affected) aphasic. To slow down or even stop the     progressive inflammatory damage to the affected brain hemisphere, immunotherapies may be     beneficial. According to a literature survey, tacrolimus (twice daily intake of capsules) and     intravenous immunoglobulins (monthly infusions) are the most promising compounds for this. In     the investigators' study, these two types of treatment are randomly assigned to patients with     disease onset within the last year and not too far advanced disability or hemispheric brain     injury. The patients are followed to assess prospectively the functional and brain MRI course     of the disease.   "
206008|NCT00545506|"     Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound     infections   "
206026|NCT00533013|"     The purpose of this study is to determine whether a nurse-led, comprehensive disease     management program is effective in reducing recurrent hospital admissions and deaths in     community dwelling patients with moderate to severe heart failure.   "
231658|NCT00885781|"     Comparison of efficacy and safety of two lipid emulsion products will be performed on     gastrectomy patients postsurgically.   "
206009|NCT00545519|"     To determine the maximum tolerated dose and dose limiting toxicity of thymoglobulin in     multiple myeloma patients.      To determine the overall response rate (CR+PR) of patients with relapsed or refractory     multiple myeloma treated with Thymoglobulin.      To determine the time to response, duration of response, and time to progression and overall     survival of patients treated with Thymoglobulin.      To determine the safety and tolerability of Thymoglobulin in these patients.      To assess the changes in lymphocyte apoptosis and apoptotic signaling in treated patients.   "
206010|NCT00545532|"     This 2-arm study will investigate the safety and tolerability of oseltamivir for the     treatment of influenza in immunocompromised participants and characterize the effects of     oseltamivir in immunocompromised participants on the development of resistant influenza     virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be     randomized to receive either conventional dose (30 milligrams [mg]-75mg twice daily orally     [po], depending on age and weight) or double dose (60mg-150mg twice daily po depending on age     and weight) Tamiflu for 10 days. Nasal and throat swabs will be taken, and safety evaluations     made, at intervals during the study. The anticipated time on study medication is 10 days and     the anticipated time on study is 40 days.   "
206011|NCT00545545|"     Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of     Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan     therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive     colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.   "
206012|NCT00545558|"     The purpose of this study is to measure the effects of anti-HIV drugs on hepatitis C virus     (HCV) viral load in people infected with both HCV and HIV.   "
206013|NCT00545571|"     This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and     tolerability of once-monthly intravenous administration of Mircera in hemodialysis     participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin     alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting     dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating     agent [ESA] dose administered on Week -1). Subsequent doses will be adjusted to maintain     hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter     [g/dL] for Switzerland and 10 to 12 g/dL for Austria).   "
206014|NCT00545584|"     To compare the efficacy of three strategies of lifestyle changes associated with Januvia     (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately     controlled by metformin (hemoglobin A1c [HbA1c] 6.5-9%). A difference between the three     strategies of lifestyle changes was expected.   "
206015|NCT00545597|"     Study of the use of Lorenzo's oil in adults with adrenomyeloneuropathy, the adult form of     Lorenzo's oil.   "
206016|NCT00545610|"     The purpose of this 12-month, observational, follow-up study is to collect additional data     (by telephone contact) with which to assess the efficacy, safety, and effects of     intramyocardial injections of adult autologous CD34+ cells on quality of life (QoL) in     subjects with chronic refractory myocardial ischemia. No treatments will be administered     during this study. However, the investigators and other study site personnel and the subjects     will remain blinded to the treatment assignments from the core therapeutic study (# 24779) so     as to provide a total of 24 months of blinded data.   "
206017|NCT00545623|"     The aims of the study are to investigate individual, combined and added effects of     acupuncture and the relaxation response in reducing gastrointestinal symptoms, improving     medication adherence and quality of life among people living with HIV/AIDS. The study will     also explore the mechanism of these therapeutic effects of acupuncture and the relaxation     response.   "
206018|NCT00545636|"     The purpose of the study is to examine if an education program of the medical teams can help     implementation of of NPO (nothing-per-os)orders in children before anesthesia for ambulatory     medical interventions under anesthesia and decrease unnecessary long fasting. We shall ask     parents of such children to fill in a questionnaire regarding pre-anesthesia fasting and     regular eating and drinking habits. Thereafter, all medical teams involved with the     administration of NPO orders will receive an educational program to explain and implement the     NPO orders as are recommended by the American Society of Anesthesiologists. We will examine     if the educational program was successful in reducing unnecessary long period of fasting, and     if such a program is not associated with increased rate of delay of cases.   "
206019|NCT00545649|"     The study aims to evaluate the effects of adding supervised exercise in supplement to an     educational self-management program, and to determine which subgroups would gain effects of     the treatment.   "
206020|NCT00545662|"     The Citicoline Brain Injury Treatment (COBRIT) is a randomized, double-blind, placebo     controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome     in patients with complicated mild, moderate and severe traumatic brain injury.   "
206021|NCT00545675|"     To demonstrate the difference between Abilify with Depakote vs. Placebo with Depakote in     24-week treatment in patients with remission status after Abilify with Depakote in the 6-week     study of acute mania in patients with bipolar disorder   "
206022|NCT00532961|"     Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular     tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of     TobraDex in healthy volunteers, when either product was administered QID (at approximately     4-hour intervals) for 28 days.   "
206023|NCT00532974|"     The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization     schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL     epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination     antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.   "
206024|NCT00532987|"     Treatment of rectal cancer often consists of surgical resection of the tumor. Chemotherapy     and/or radiotherapy are frequently given before or after surgery. In this study, we wish to     learn if there are differences in the treatment effectiveness or in the quality of life of     patients based on their type of treatment (e.g. Radiotherapy and chemotherapy before or after     surgery). Information from this questionnaire collected from you and other patients may help     improve the quality of life of rectal cancer patients in the future. Medical information on     your tumor, treatment received, and side effects will be compiled and maintained in a     database to learn more about outcomes of treatment for rectal cancer.   "
206027|NCT00533026|"     To evaluate the blood clotting effects of multiple doses of warfarin at steady state when     taken at the same time as multiple doses of duloxetine as measured by changes in the     International Normalised Ratio. All subjects will begin dosing with warfarin, then after     approximately 12 days, duloxetine 60 mg is added and subjects with stabilized INR will either     continue dosing at 60 mg or have a dose increase to 120 mg.   "
206028|NCT00533039|"     As evidence accumulates that atherogenesis or Coronary Artery Disease (CAD) may not be simply     a disorder of lipid metabolism, but an inflammatory disease, the focus of treatment has     shifted. A-002 or Varespladib is an anti-inflammatory drug for treatment of chronic and acute     diseases. It acts by inhibiting secretory phospholipase A2 (sPLA2 ) - one of a family of     enzymes leading to inflammation - which may be important in: 1) the development of     atherosclerosis and 2) the increase in occurence of cardiovascular events after angioplasty.     Previous studies have demonstrated that sPLA2: 1) facilitates the pro-atherogenic effects of     low-density (LDL or bad cholesterol) and 2) increased levels post-angioplasty correlate with     an increased risk of events at followup contact. Therefore this study proposes to investigate     the ability of A-002 to prevent or reduce myocardial damage after angioplasty by inhibiting     the cascade of inflammatory mediators.      Substudy - Subjects who agree will also have a vascular ultrasound 24h post-PCI to assess     endothelial function.   "
206029|NCT00533052|"     Behavioral weight loss, the current treatment of choice for moderate obesity, achieves     impressive short term results, however, weight regain following treatment is a major problem.     Over 50% of participants in behavioral weight loss programs report difficulty with internal     antecedents to unhealthy weight control behaviors and this difficulty is associated with     weight regain following treatment. Current treatment approaches do not adequately address     these antecedents. The aim of this series of studies is to develop, implement, and evaluate a     behavioral weight loss program modified to provide participants with skills to deal     effectively with affective and cognitive difficulties. The study targets men and women with     BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to     unhealthy weight control behaviors. The study is an uncontrolled pilot study in 20     participants to initially assess acceptability and efficacy of the innovative treatment. The     long-term goal of this research is to improve the weight loss maintenance outcomes of     behavioral weight loss programs by addressing affective and cognitive antecedents to     unhealthy weight control behaviors.   "
206030|NCT00533065|"     The planned study has two purposes:        1. It is to provide evidence that the administration of a cholinesterase inhibitor will          result in an increase of IGF-I (primary variable) and in an increase of the secretion          growth hormone (secondary variable) that can be maintained throughout the          treatment-period of one year.        2. The study also tests the hypothesis that maintenance of increased blood levels of growth          hormone and IGF-I can stop or delay the age-related changes of body composition          (secondary variables) .   "
206031|NCT00533078|"     In patients with acute myelogenous leukemia (AML), a high proportion will suffer from     inflammation of the large bowel (colitis) during their intensive treatment. As there is no     standard treatment available for this potentially lifethreatening condition, the     investigators focus on the role of parenteral nutrition which these patients inevitably     require. Preclinical and clinical data have shown strong anti-inflammatory properties of fish     oil preparations containing poly-unsaturated omega3 fatty acids (PUFA) as opposed to other     lipid fractions. There may be a therapeutic benefit of adding omega3 PUFA to standard     nutrition in patients with chemotherapy-induced colitis. In this small phase II study, the     investigators address the effectiveness of this approach to reduce the incidence and severity     of colitis in AML patients.   "
206032|NCT00533091|"     The primary objective of the study is to evaluate the safety and tolerability of multiple IV     doses of MEDI-545 in adult patients with myositis.   "
206033|NCT00533104|"     The primary focus of the trial is safety and efficacy of the intra-muscular implantation of     either bone-marrow, or peripheral blood mononuclear cells, in critical limb ischemia, as     judged by the proportion of patients which are alive without major amputation 6 months after     inclusion.   "
206034|NCT00533117|"     This study will determine whether dialectical behavior therapy and fluoxetine are more     effective combined or alone in treating people with borderline personality disorder.   "
206035|NCT00533130|"     1. Is the AO Pediatric classification for long bones fractures reproductible?        2. Is the AO Pediatric Classification for long bones fractures a treatment guide?        3. The AO pediatric Classification for long bones fractures could be a prognosis factor?   "
206036|NCT00533143|"     The occurrence of acute respiratory failure (ARF) is often seen by oncologists as a terminal     phase of the disease, this view being based on studies reporting limited survival at     considerable costs in such patients. A large proportion of cancer patients with severe     respiratory failure are denied admission to an ICU because intensive care specialists are     aware that intubation and mechanical ventilation are both strong predictors of mortality in     critically ill cancer patients. This holds particularly true in the subset of patients who     are not receiving chemotherapy or radiotherapy because of the advanced stage of their     disease, and who are also not affected by an episode of ARF, related to a reversible cause.      These patients often receive oxygen therapy and morphine in an attempt to improve oxygenation     and/or relieve the ensuing dyspnea.      Non-invasive mechanical ventilation (NIV) is now the first line treatment of ARF in selected     populations (e.g., those with COPD) and has been used sporadically as a potential treatment     of acute respiratory failure in patients with a do-not-intubate order. The International     Consensus Conference on Intensive Care Medicine stated that the use of NIV may be justified     in selected patients who are not to be intubated and may provide patient comfort and     facilitate physician-patient interaction. Early NIV has been successfully used so far in     cancer patients only to prevent intubation among those with hematologic malignancies, while a     pilot study has assessed the feasibility of NIV also as a palliative treatment of end-stage     solid cancer patients. So far we are lacking data about the pure palliative effects of     NIV,in patients with end-stage solid cancer.      The aim of this multicenter randomised study will be to evaluate on a large scale the     feasibility, clinical efficacy and impact on quality of life and dyspnea of NIV versus     standard medical in patients with respiratory failure, not related to a reversible cause, and     solid cancer needing palliative care treatment.   "
206037|NCT00533156|"     The purpose of this study is to assess the safety and feasibility of the 7F Ensure Medical     Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or     interventional coronary procedures using a standard 7F introducer sheath.   "
206083|NCT00539123|"     A randomized clinical trial evaluating whether Behavioral Drug and HIV Risk Reduction     Counseling (BDRC), abstinence-contingent take-home buprenorphine (ACB), or the combination of     the two improve efficacy and cost-effectiveness of standard buprenorphine treatment for     opiate-dependent individuals in Malaysia.   "
236545|NCT00954408|"     The purpose of this study is to determine how common fatigue and sleepiness are in patients     with dystonia.   "
206038|NCT00533169|"     The goal of this clinical research study is to find the highest safe dose of the drug     ZactimaTM (ZD6474) in patients with neuroblastoma or medulloblastoma that has gotten worse,     has come back, or has not responded to the treatment.      Primary Objective:      -To determine the pharmacokinetics, safety, dose-limiting toxicities, and maximum tolerated     dose of ZD6474, alone in children with medulloblastoma, and alone in combination with     retinoic acid, in patients with relapsed or refractory neuroblastoma.      Secondary Objective:      -To assess progression-free survival (PFS) and objective tumor response rates in children     with relapsed and refractory neuroblastoma and medulloblastoma treated with ZD6474 +/-     retinoic acid in the context of a Phase I trial.   "
206039|NCT00533182|"     This study will evaluate how the immune system responds to influenza infection and compare     how the infection differs in patients with a weakened immune system versus those with a     healthy immune system.      Patients at the NIH Clinical Center who are older than 2 years of age and who are diagnosed     with influenza A or B may be eligible for this study. Patients with healthy immune systems     and weakened immune systems are included.      Participants answer questions about how they are feeling and have a physical examination to     evaluate their symptoms. Blood and nasal fluid are collected on the first day and then every     other day for a total of 8 days. Nasal fluid is collected by either inserting a small tube in     the nose and washing the nose with salt water and collecting the fluid obtained, or by     rubbing the inside of the nose with a swab. Physical examinations are repeated on the days     that blood and nasal fluid are collected.   "
206040|NCT00533195|"     The purpose of this study is to compare the efficacy, tolerability and remission duration of     UVA 1 therapy versus 5-MOP UVA photochemotherapy for patients with severe generalized atopic     dermatitis.   "
206041|NCT00533208|"     To assess the efficacy of MK0524 on seasonal allergies.   "
206042|NCT00533221|"     The purpose of this study is to determine whether Growth hormon can increase strength in     spinal muscular atrophy type II and III.   "
206043|NCT00533234|"     The purpose of this prospective clinical data collection is to document the performance and     clinical outcomes of the ExploR® Modular Radial Head. This data collection effort will     document the clinical outcomes of the radial head.   "
206044|NCT00533247|"     This double blinded, placebo controlled, study seeks to determine the efficacy of     preoperative anti-inflammatory therapy on the reduction of postoperative pain in knee     arthroplasty surgery. Pre-emptive use of NSAIDS has demonstrated only modest reduction in     post-operative pain in previous studies. However, the short duration of dosing in those     studies did not capitalized on the anti-inflammatory properties of NSAIDS. Short-term use of     NSAIDS only provides pain relief and does not address inflammation. Traditional NSAIDS cannot     be used preoperatively due to platelet effects. Celecoxib, however, is both an analgesic and     anti-inflammatory, but does not interfere with bleeding. It can therefore be safely used     before surgery. This study hypothesizes that the use of celecoxib for seven days     preoperatively reduces postoperative inflammation and consequently pain. A detailed Medline     search has not identified any studies into the preoperative use of an NSAID at a dosing level     that achieves anti-inflammatory effects.If effective in reducing postoperative pain, this     research could lead to a new understanding of the role inflammation plays in orthopedic     procedures and other elective procedures and thus improve patient outcomes in the future.   "
206045|NCT00533260|"     The basic hypothesis of this trial is that forgetfulness and failure to establish a routine     that facilitates medication adherence are prominent reasons for non-adherence. Daily use of     the SMS text messages is designed to enhance patient adherence with medication by promoting     daily routine and demonstrate the feasibility of using SMS technology within normal clinical     practice in The Netherlands.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
206046|NCT00533273|"     This 12-month study had two phases: a 90-day double-blind, randomized, placebo-controlled     phase and a nine-month open-label extension phase. Before treatment, eligible subjects were     stratified by the primary joint type (30 metacarpophalangeal [MP] joints and 30 proximal     interphalangeal [PIP] joints) and by severity of the primary joint contracture (ie, up to 50°     or >50° for MP joints and up to 40° or >40° for PIP joints) and then randomized in a 2:1     ratio to either AA4500 0.58 mg or placebo. Upon completion of the double-blind phase (ie,     90-day evaluation after the first injection), all subjects were eligible to enter the     open-label extension phase of the study in which they were followed for an additional nine     months. Subjects who required further treatment because they either did not achieve reduction     in contracture to 5° or less, the cord affecting the primary joint received placebo, another     cord received less than three injections of AA4500, or they had untreated cords that were     affecting other joints had the option to receive up to five additional injections of AA4500     0.58 mg in the open-label extension phase, with individual cords receiving up to three     injections of AA4500.      This study was designed to be part of the larger clinical program, for adult patients with     Dupuytren's contracture with a palpable cord, where the data from 2 pivotal     Placebo-Controlled studies (AUX-CC-857 [NCT00528606] and AUX-CC-859 [NCT00533273]) and 7     non-pivotal studies were evaluated.   "
206047|NCT00533286|"     Sixty patients were randomized to receive either placebo or diazepam in addition to     mechanical physiotherapy and analgesics for the first 7 days of conservative treatment of     clinically and radiologically confirmed lumbar disk prolapse   "
206048|NCT00533299|"     The current standard for recurrent, persistent or metastatic cisplatin-resistant ovarian     cancer is palliative chemotherapy with either topotecan, liposomal doxorubicin or     gemcitabine, however, the results need to be improved. Epigenetic aberrations play an     important role in cancer progression by silencing growth regulatory genes and there is now     evidence that inhibitors of DNA methylation and HDAC inhibition synergize the cytotoxicity of     chemotherapy.      Objective. To determine the superiority of epigenetic therapy with hydralazine and valproate     plus topotecan over placebo plus topotecan upon progression-free survival.      Hypothesis. Hydralazine and magnesium valproate associated to topotecan will increase     progression-free survival from 6 to 9 months as compared with the same regimen of     chemotherapy plus placebo.   "
206049|NCT00533312|"     A study to determine lipid changing effects of MK0524A when compared to niacin extended     release (NIASPAN) and placebo.   "
239688|NCT00985764|"     Effects of placenta previa on incidence and severity of venous air embolism in patients     during cesarean delivery   "
206050|NCT00533338|"     The specific aims of this study are:        1. To test the feasibility of a randomized controlled trial of a weight gain prevention          program for breast cancer survivors that combines exercise and dietary changes during          treatment. Feasibility will be evaluated by examining data on recruitment rate,          attendance at intervention sessions, drop-out rates in both study conditions, assessment          completion rates, and participant feedback.        2. To test the effect of a weight gain prevention program, compared to usual care, on          weight, body composition, and biomarkers related to breast cancer prognosis.        3. To explore whether changes in physical activity, energy intake, and resting energy          expenditure predict weight gain among breast cancer survivors.        4. To test the effect of a weight gain prevention program on quality of life variables.   "
206051|NCT00533351|"     This study will explore the safety and efficacy of AGN201781 in patients with postherpetic     neuralgia or post-traumatic peripheral neuralgia   "
206052|NCT00533364|"     This study is set up to determine whether soluble beta-glucan (SBG) has        -  unfavourable side effects        -  beneficial treatment effects when given in combination with standard antibody and          chemotherapy to patients with breast cancer.   "
206053|NCT00533377|"     The purpose of this study is to find out the good and bad effects of an investigational drug     called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal     fixation using reamed inter-locked IM nailing procedure   "
206054|NCT00533390|"     Rifampicin is a potent inducer of the CYP450 and decrease the plasmatic concentration of     NNRTI and Protease Inhibitors. In our study we are going to compare the 600 an 800mg doses of     efavirenz concomitant of rifampicin use to treat tuberculosis. The hypothesis is that the 800     mg dose would be more adequate than the 600mg   "
206055|NCT00533403|"     To compare the pain relieving effect of MK0686 to placebo or ibuprofen after dental surgery.   "
206056|NCT00533416|"     This study will determine the highest dose of the experimental drug ON 01910.Na that can     safely be given to patients with the bone marrow disorder myelodysplasia (MDS) and patients     with refractory AML with trisomy 8. In this disease, the bone marrow can make some blood     cells, but very few of these cells are released into the blood for use in the body. ON     01910.Na is an experimental drug that inhibits a protein called cyclinD1that is important for     keeping MDS cells alive. In laboratory experiments, ON 01910.Na has acted against cyclinD1,     causing MDS cells to die. The study will also evaluate how the body handles ON 01910.Na, the     effect of the drug on MDS and AML and its side effects.      Patients 18 to 85 years old with MDS or AML who do not have a suitable sibling donor for a     marrow transplant or who are not willing to have a transplant may be eligible for this study.      Participants receive ON 01910.Na in 2-week treatment cycles, with 3 to 5 days of drug     infusion through a vein followed by 9 to 11 days of observation. To find the highest safe     dose of ON 01910.Na, the first person enrolled in the study is given the smallest study dose     of the drug for 3 days, followed 2 weeks later with a second dose for 3 days. If these doses     are found safe, the next two people receive the same dose. If these subjects do well, the     next group of patients receives the next higher dose level. The dose continues to be     increased in groups of 3 to 6 subjects until the fourth and highest dose level is reached.     Patients who do well on the treatment may receive an additional six cycles of ON 01910.Na (3     to 5 days of infusion once every other week for 12 weeks).      Before, during and after the treatment period, patients are periodically evaluated and     monitored with the following tests and procedures:        -  Physical examination and review of medical and medication history.        -  Blood and urine tests.        -  Pregnancy test for women of childbearing age.        -  Electrocardiogram (EKG) and chest X-ray.        -  Bone marrow biopsy.   "
206057|NCT00533429|"     The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab     plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival     time without disease progression in the first-line treatment of patients with advanced stage     non-small cell lung cancer.   "
206058|NCT00533442|"     This study was designed to determine which maintenance immunosuppressive agent, rapamycin or     mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal     failure, who presented for a kidney-pancreas transplant.   "
206059|NCT00533455|"     We will attempt to establish whether gabapentin as compared with placebo will reduce the     severity of tremors caused by the use of antipsychotic medications. Baseline severity of     tremor will be measured using both clinical ratings and ratings obtained with an instrument     designed to measure tremor, giving more objective evidence of tremor frequency and severity.   "
206060|NCT00533468|"     The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of     infants undergoing Lumbar Puncture (spinal tap).   "
206061|NCT00533481|"     Study medicine will be given alone, or in combination with either sibutramine or orlistat, to     obese subjects to compare the effect on body weight over a six month period.   "
206062|NCT00533494|"     Despite the advent of efficacious medicines, there is a gap between ideal and actual care in     the achievement of recommended outcomes among diabetic patients. The study enrolled 429     diabetic patients attending four HMO clinics in Israel, two in the northern region and two in     the southern region. All clinics were randomly selected from all clinics affiliated with the     Faculty of Health Sciences of the Ben Gurion University. The objective of the study was to     compare the effects of a multi-component physician-patient intervention to physician feedback     alone on a combined outcome of diabetes, blood pressure and serum lipids control. We     hypothesized that in medical practices where physicians have received feedback on quality of     care indicators, patients who received a letter encouraging them to discuss a list of     important diabetes-related issues with their doctors, would experience better outcomes     compared to patients who did no received such a letter.   "
206063|NCT00533507|"     The purpose of this study is to assess the immunogenicity in terms of antibody response and     the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse     events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine     GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined     vaccine and rotavirus vaccine in children during the first 6 months of life.   "
206064|NCT00533520|"     Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet     age-related macular degeneration (AMD).   "
206084|NCT00539136|"     This study will be conducted in healthy volunteers to investigate the absorption of GSK561679     using Gamma Scintigraphy, PillCam™ SB capsule and the acoustic vest.   "
206096|NCT00539292|"     This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS)     to treat infants with gastroschisis will result in improved outcomes, faster recovery times     and fewer post-surgical complications than the standard selective use of the silo.   "
206378|NCT00543010|"     A study to evaluate the cardiac and metabolic effects of MK0767 in patients with Type 2     Diabetes.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
206065|NCT00533533|"     Gastric cancer is the most common malignancy in Korea. The prognosis of unresectable gastric     cancer has been improved by cytotoxic chemotherapy, but median survival rarely exceeds 1     year. New agents such as taxane, irinotecan and oxaliplatin combined with old agents such as     5-FU with or without leucovorin, doxorubicin, cisplatin showed higher response rates in phase     II studies. Docetaxel as a single agents showed response rates of 17-24%, and the combination     of docetaxel and cisplatin has shown a response rate of 37-56% and overall survival of 9-10.4     months. Oxaliplatin in combination with 5-FU and leucovorin(FOLFOX-6) showed an objective     response rate of 50%, which included a 4% complete response. The preclinical studies,     oxaliplatin has shown additive or synergistic cytotoxic properties with fluoropyrimidines,     thymidylate synthase inhibitors, topoisomerase I inhibitors, microtubule inhibitors and DNA     modifying/alkylating agents. The combination of docetaxel and oxaliplatin has been studied     previously in the phase I setting in patients with metastatic breast and non-small cell lung     cancer. The combination of docetaxel and oxaliplatin is a feasible and well tolerated     regimen. Recommended doses were 75mg/m2 for docetaxel on day 1 and 70mg/m2 for oxaliplatin on     day 2 without G-CSF support. The aim of this trial is to determine the dose limiting     toxicities, maximum tolerated dose(MTD) and efficacy of oxaliplatin and docetaxel as     combination chemotherapy in patients with advanced gastric cancer.   "
206066|NCT00533546|"     The purpose of this research study is to determine the safety and learn more about the dose     of Activated Protein C (APC) in reducing the damage from stroke.   "
206067|NCT00533559|"     An increase of plasma free fatty acids impairs insulin secretion and insulin sensitivity,     thereby playing an important role in causing type 2 diabetes. Lipotoxicity plays an important     role in the progression from normal glucose tolerance to fasting hyperglycemia and coversion     to frank type 2 diabetes. A recent publication in the journal Science showed that buphenyl,     when given to obese diabetic mice, resulted in normalization of hyperglycemia, restoration of     systemic insulin sensitivity, resolution of fatty liver disease and inhancement of insulin     action in liver, muscle and adipose tissue. the mechanism of action is believed to be due to     reduction of endoplasmic reticulum (ER) stress. Buphenyl is currently approved for the     treatment of rare inherited disorders of the urea cycle. We plan to administer Buphenyl     orally to humans at a dose far lower than that used for the treatment of urea cycle disorders     for 2 weeks prior to the testing of pancreatic function. One potential mechanism whereby     chromically elevated plasma FFAs and glucose impairment beta cell function and insuln     sensitivity is by ER stress and this can be prevented by administeration of buphenyl.   "
206068|NCT00533572|"     Recessive Dystrophic Epidermolysis Bullosa (RDEB) is a severe inherited blistering skin     disease caused by absence of type VII collagen. Patients with RDEB develop large, severly     painful blisters and open wounds from minor trauma to their skin. In the future, we hope to     start a gene transfer study on a specific group of RDEB subjects and we are screening     subjects for that potential trial now.   "
206069|NCT00533585|"     The goal of this study is to find the highest tolerable dose of BAY 43-9006 (sorafenib) and     bevacizumab that can be given with paclitaxel and carboplatin in patients with non-small cell     lung cancer (NSCLC). The safety and effectiveness of this drug combination will also be     studied.   "
206070|NCT00533598|"     The purpose of this study is to assess the effects of MK0557 on body weight in obese     subjects.   "
206071|NCT00533611|"     The primary objective of the study is to assess the effects of MK0524A in reducing flushing     associated with niacin.   "
206072|NCT00533624|"     The comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150     sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first     and second living or deceased donor renal transplant recipients.   "
206073|NCT00533637|"     Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance   "
206074|NCT00533650|"     A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis.   "
206075|NCT00533663|"     To study the effectiveness of Healing Touch provided during chemotherapy infusions on the     experience of women undergoing treatment for breast cancer. Healing Touch (HT) is a gentle,     non-invasive form of energy-balancing work that promotes relaxation and can help manage the     side effects of chemotherapy.   "
206076|NCT00533676|"     To determine the most effective daily dose of MK0524A when compared with placebo after the     8-week treatment period for Niacin Induce Flushing (NIF).   "
206077|NCT00539032|"     This study will be conducted among children in Saudi Arabia who previously received two doses     of A, C, Y, W-135 polysaccharide vaccine before the age of 2 years, and in meningococcal     vaccine-naïve children (Control Group). This study will evaluate the administration of     Menactra® in terms of the serum bactericidal antibody it induces in the two study groups.     Safety of Menactra® vaccine will be described.   "
206078|NCT00539045|"     This is a cross-sectional study of post myocardial infarction patients which is designed to     determine the prevalence of left ventricular thrombi (blood clots) using non-contrast     echocardiography and to compare this with the prevalence of left ventricular thrombi using     contrast echocardiography. Secondary aims of this study are (1) to identify clinical and     imaging correlates of left ventricular thrombi, and (2) to compare quantitative measurements     of left ventricular chamber size, function, and myocardial mass using contrast and     non-contrast echocardiography.   "
206079|NCT00539071|"     The purpose of this study is to look at two doses of long-acting injectable risperidone     (Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every     two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better     at improving symptoms of schizophrenia or schizoaffective disorder.   "
206080|NCT00539084|"     The purpose of this study is to determine whether the MicronJet microneedle device is     effective for inducing rapid and painless local anesthesia prior to insertions of intravenous     catheters.   "
206081|NCT00539097|"     The investigators hope to learn if taking a nutrition drink for a short time after surgery     for an elective reconstructive burn injury improves donor site healing, muscle mass and scar     maturation time (the point at which the redness, height and firmness of the wound has faded,     flattened and softened, and no longer changes in appearance).   "
206082|NCT00539110|"     To examine sleep changes following therapeutic drug interventions designed to promote sleep.   "
206085|NCT00539149|"     This clinical trial was conducted in a population where tympanic membrane perforation occurs     in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination)     with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear     infection throughout childhood. The trial aimed to assess whether twice daily antibiotics     commencing at first detection of middle ear effusion would cure the infection and/or prevent     disease progression, compared to placebo.      The study was conducted in three remote Aboriginal communities in the Northern Territory of     Australia. The annual birth cohort was 45.      Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until     middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following consent,     infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent for up to     24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled     examinations. At monthly examinations the infant also had a general health check, parents     were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were     collected.   "
206086|NCT00539162|"     The goal of this clinical research study is to evaluate a method involving a blood test,     called CA-125, that may be helpful in the early detection of ovarian cancer in women who are     at low risk.   "
206087|NCT00539175|"     1. Objectives:        1. To assess the efficacy of Photon Stimulation compared with placebo, in treating the pain          of diabetic neuropathy.        2. To show that Photonic Stimulation for the treatment of painful diabetic neuropathy is          cost effective compared to traditional medical interventions. The latter will be          explored by an extensive search of the literature and from an equal number of patients          being treated in traditional medical practices using traditional medical interventions.          At the conclusion of the study the data will be analyzed for cost-benefits and the          possibility of crafting a best-practices approach to treat these syndromes that cost          billions of dollars a year in health care expenses and lost productivity.      2. Research Design      This is a double blinded, randomized, placebo-controlled study of 120 patients with painful     diabetic neuropathy. These 120 will be randomly assigned treatments utilizing Photon Therapy,     using a defined treatment protocol. We expect that some patients will drop out, and our goal     is 100 treated patients, for statistical purposes. The Photon Therapy group will be split     into two groups, one group that receives Active Photon Therapy and one group that will be     treated with the same type of equipment that has been modified to emit no infrared photons     (Non Active Photon Therapy Group (Placebo)). The patients in the Non Active Photon Therapy     Group will be offered an Active Photon Treatment Session after completion of the study. The     patients in the Photon Therapy Groups will be randomized. There will also be an Historical     Control Group of patients, fifty, will have received traditional medical interventions (e.g.,     narcotics, seizure medications) in traditional medical practices. Data from these individuals     will be used to calculate potential cost savings.      3. Methodology:      Subjects who meet the inclusion and exclusion criteria and have signed a valid informed     consent will be eligible to participate in the study. After screening, subjects in the Photon     Therapy groups (both active and nonactive) will undergo four treatment sessions. The first     treatment session will vary from the second, third and fourth. During all treatment session,     each patient will be imaged with the TIP Infrared Camera before, and after treatment.     Infrared imaging can visualize skin temperature changes in a noninvasive manner (2). The     first treatment will utilize slightly different protocol than subsequent visits, reduced     Photon dosage, 120 instead of 240 joules. Proprioception and protective sensation,     characterized by the Semmes-Weinstein monofilament test, and visual and analog pain scoring     will also be evaluated before and after each Photon Therapy treatment.      4. Finding:      To date, we have just completed 120 patients, using a block randomization scheme not     previously reported in this field. We have collected data on nerve function, pain, quality of     life, and skin circulation. The data will remain stored until the study is complete to     preserve the blinded nature of the project. Data analysis is still incomplete.      4. Clinical Significance      Diabetic neuropathy is a chronic and progressive condition that potentially leads to     disabling pain, and worse, amputation, for many individuals in the United States each year.     Present treatments utilize antiseizure medications, opiate analgesics, and antidepressants,     and are inconsistently effective. Development of a new treatment strategy potentially could     have significant benefit for a great many patients.   "
206088|NCT00539188|"     Self-Injurious Behavior (SIB) is a dangerous and common symptom in Borderline Personality     Disorder (BPD) patients. Approximately 70% of patients with BPD engage in SIB at some point,     compared to 17.5% of patients with other personality disorders. While SIB may prompt     unnecessary psychiatric hospitalizations, it may also cause potential underestimation of the     lethality of suicidal behavior, thus creating a major and confusing challenge in the practice     of clinical psychiatry.      Dialectical Behavioral Therapy (DBT) is a collection of therapeutic techniques focused on     emotional regulation, impulse control, and improving safety in patients with BPD and others     with marked self-destructive behavioral tendencies. Though DBT has marked ability to reduce     BPD symptomatology, including SIB, improvement in SIB is limited and dependent on extensive     therapy and time.      Furthermore, the literature on the pharmacological treatment of SIB associated with BPD is     scarce. Animal studies suggest that SIB may be associated with an imbalance between dopamine     and glutamate in the brain. Anti-seizure medications that modulate glutamate transmission,     such as lamotrigine and topiramate, have been suggested to be effective in the treatment of     SIB in humans.      Preliminary evidence suggests that antiglutamatergic medications may decrease SIB in patients     with BPD. Early studies have focused on the antiglutamatergic drug riluzole. More recently,     we have become interested in the amino acid N-acetylcysteine (NAC), which is used clinically     for its antioxidant properties and is widely available as a nutritional supplement. Recent     animal studies have suggested that NAC can modulate glutamate in the central nervous system     in a way very similar to that proposed for riluzole, and indeed we have observed NAC to have     an effect similar to riluzole in a case of treatment-refractory obsessive-compulsive     disorder.      This study will be a double-blind, randomized, and placebo-controlled evaluation of     N-Acetylcysteine as an adjunct to DBT in the treatment of SIB associated with BPD. Subjects     participating in this study will be recruited exclusively from the Dialectical Behavioral     Therapy program of the Yale-New Haven Hospital, in order to maximize homogeneity of the     psychotherapeutic care received during their participation.   "
206089|NCT00539201|"     To determine safety, tolerability and pharmacokinetics of GSK706769   "
206090|NCT00539214|"     -  To compare the effect of pramipexole on depressive symptoms in early and advanced PD          patients        -  To evaluate the course of depressive symptoms measured with UPDRS Part I (mentation,          behavior and mood) and with HADS-D under pramipexole treatment        -  To investigate whether improvement of depressive symptoms is linked to improvement in          motor function (UPDRS Part III)   "
206091|NCT00539227|"     The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an     alternative procedure to the standard skin-sparing mastectomy for women who have breast     cancer or are at high-risk for developing breast cancer. You have been asked to take part in     this study because your treating surgeon feels you are a candidate for skin-sparing     mastectomy and because you want breast reconstruction after surgery. Outcomes that will be     measured include how much nipple sensation can be kept after surgery; how satisfied you are     with how the breast looks after surgery; complication rates; and your quality-of-life.   "
206092|NCT00539240|"     The purpose of this project is to compare the efficacy (how successful) 1) standard-dose     proton pump inhibitor (PPI) (rabeprazole 20 mg once daily) (a medication that completely     blocks the stomach from producing acid) plus low dose tricyclic antidepressant (nortriptyline     50mg) (TCA); 2) double-dose PPI (rabeprazole 20 mg twice a day); to 3) standard-dose PPI     (rabeprazole 20mg once daily) and placebo (an inactive substance, like a sugar pill) to     determine the relative symptom resolution and health-related quality of life in     gastroesophageal reflux disease (a disease characterized by a burning sensation (heartburn)     behind the breast bone caused by a backflow of stomach contents into the esophagus) (GERD)     patients who fail standard-dose PPI and you will be randomly assigned (similar to flipping a     coin) to one of the three groups.   "
206093|NCT00539253|"     This research is being done to find out if using the contrast agent MultiHance can be used to     show how a liver tumor responds to the chemotherapy given during Transcatheter Arterial     Chemoembolization (TACE).      MultiHance is approved by the Food and Drug Administration (FDA) for use as a contrast     material for Magnetic Resonance Imaging (MRI) scans of the central nervous system. It is     believed that using MultiHance may be able to help doctors tell normal liver cells apart from     active tumor and from tumor affected by the chemotherapy. In this way, MultiHance may improve     the way patients with hepatocellular carcinoma are managed clinically.      We hypothesize that the Multi-Hance contrast material will provide better image definition of     treated liver tumor(s) on MRI imaging in comparison to other commercially available contrast     agents.   "
206094|NCT00539266|"     The investigators propose confirm and extend the findings of open studies on the apparent     efficacy of bone-marrow derived mononuclear cells for the induction of arteriogenesis in     patients with severe claudication or critical leg ischemia and pay special attention to the     influence of diabetic disease on the outcome of the study and to the possible     pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.   "
206095|NCT00539279|"     This project represents the first randomized clinical trial of psychotherapy for older     veterans with posttraumatic stress disorder (PTSD). It will compare relaxation training (RT)     to prolonged exposure therapy (PE). The project will also examine whether cognitive     impairment influences psychotherapy outcome.      Primary hypotheses: (1) Subjects in the PE condition will have significantly less severe PTSD     symptoms, depressive symptoms, and functional impairment than subjects in the RT condition at     posttest; (2) Executive functioning will modify the response to both treatments, such that     those with impaired executive functioning will demonstrate a smaller reduction in PTSD     symptoms (representing less clinically significant change).   "
230505|NCT00863733|"     This is a phase I study aimed at identifying safe doses of DMXAA in patients with solid     tumors.   "
206097|NCT00539305|"     The purpose of this study is to examine the effects of testosterone (T) replacement on     changes in thinking and memory, as well as mood in older men with mild cognitive impairment     (MCI) and low T levels. The study will also examine whether taking testosterone has effects     on biological markers related to Alzheimer's disease.   "
206098|NCT00539318|"     The proposal seeks to establish:        -  A comprehensive compilation (database) of clinical information comprising clinical,          histopathological, treatment and follow-up characteristics of past and future          gastrointestinal cancer (GIC) cases in Singapore that can be shared by investigators.          The characteristics will include clinical (eg age, sex, stage), histopathological (eg.          grade, type), treatment (eg. treatment status, regimens) and outcome data (eg. survival,          toxicity) from medical records.        -  A collection (bank) of corresponding frozen and fixed tissue, blood and processed          samples (enriched blood mononuclear cells, protein, RNA, DNA, tissue arrays) in          Singapore that can be shared by the investigators.        -  A gastrointestinal cancer co-operative group (GCCG) of clinicians and scientists          researching prognostic and predictive markers in GIC, which will benefit from the          multidisciplinary knowledge, information and samples of its members.   "
206099|NCT00539331|"     The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed     AstraZeneca that the BR24 Phase II/III study of cediranib at 30mg in first line non-small     cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase     II efficacy and tolerability analysis by the study's Data Safety Monitoring Committee.     Although evidence of clinical activity was seen, there appeared to be an imbalance in     toxicity and therefore the study was considered not to have met the pre-defined criteria for     automatic continuation into Phase III. As the design of Study 040 is similar to that of Study     BR24, AstraZeneca has suspended recruitment into Study 040.   "
206100|NCT00539344|"     This is a phase 1, multi-centre, sequential cohort, open-label, dose-escalation study of the     safety, tolerability, and PK of ANG1005 in patients with recurrent or progressive malignant     glioma. ANG1005 will be given by IV infusion once every 21 days (1 treatment cycle). Each     patient will participate in only 1 dose group and will receive up to 6 cycles of treatment     provided there is no evidence of tumor progression, there is recovery to ≤Grade 1 or baseline     nonhematologic, ANG1005-related toxicity (except alopecia), the absolute neutrophil count is     ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L.   "
206101|NCT00539357|"     Cranial electrotherapy stimulation(CES) is a noninvasive procedure that has been used for     decades in the United States to treat anxiety, depression, and insomnia in the general     population. Whether CES is an effective treatment for patients with a DSM-IV diagnosis of     generalized anxiety disorder (GAD) has not previously been explored. The goal of this study     was is to evaluate the efficacy of CES in alleviating anxiety in patients with     DSMIV-diagnosed GAD. Specifically our hypothesis was that CES would demonstrate possible     efficacy in reducing symptoms associated with GAD from baseline to end of trial, as     determined by: (1) change from baseline in the Hamilton Anxiety Scale (HAM-A) total score.     a.) the proportion of responders (much or very much improved) as assessed by the CGI     Improvement ratings by visit b.) the proportion of responders (50% reduction from total HAM A     baseline score) according to the HAM A scores by visit c.) the proportion of patients in     remission (HAM A score ≤7) by visit   "
206102|NCT00539370|"     This protocol will enable IRB (institutional review board) review of proposed research using     human samples and data collected under the terminated NIH studies 04-EI-0065 and 96-EI-0096.     Data and samples may include demographic and personal health information, psychological or     psychiatric testing, blood, urine, CSF or other body fluids or tissues and results of medical     and physiological evaluation and medical imaging.      Data and sample analyses are limited to those approved under the original protocols unless     additional specific institutional review board approval is obtained.   "
206103|NCT00539383|"     This is a phase 1, multi-centre, sequential cohort, open-label, dose-escalation study of the     safety, tolerability, and PK of ANG1005 in patients with solid tumors (with or without brain     metastases). ANG1005 will be given by IV infusion once every 21 days (1 treatment cycle).     Each patient will participate in only 1 dose group and will receive up to 6 cycles of     treatment provided there is no evidence of tumor progression, there is recovery to ≤Grade 1     or baseline nonhematologic, ANG1005-related toxicity (except alopecia), the absolute     neutrophil count is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L.   "
206104|NCT00539396|"     A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to     insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine   "
206105|NCT00545688|"     This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in     female patients with locally advanced, inflammatory or early stage HER2 positive breast     cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4     cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin +     pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of     840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg     3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the     entire pre- and post-surgery period all patients will receive adequate chemotherapy as per     standard of care, as well as any surgery and/or radiotherapy as required. The anticipated     time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
206106|NCT00545701|"     The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support     the immunogenicity data from previous clinical studies.      Objectives:        -  To describe the immune response 21 days after each vaccination.        -  To describe the safety profiles following each vaccination.   "
206107|NCT00545714|"     This single arm study will assess the efficacy and safety of rituximab in combination with     fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line     treatment of participants with CLL.   "
206155|NCT00546390|"     The purpose of this study is to compare a treatment called remote ischemic preconditioning     (rIP) to no treatment. rIP is a simple treatment that is believed to help patients recover     better after heart surgery. This treatment involves applying a large blood pressure cuff to     one leg. The blood pressure cuffs will be inflated for 5 minutes and then deflated for 5     minutes. This will be done 4 times in a row.   "
206108|NCT00545727|"     Research to date suggests that the selection of lower glycemic index foods, that is, foods     provoking a slower, more sustained blood sugar response, may result in improved glycemic     control in youth with diabetes. However, there is currently insufficient data to support     practice recommendations. The purpose of this pilot study is to test the blood glucose     response to low and high glycemic index meals in youth with diabetes using continuous blood     glucose monitoring, and to determine whether the effect of glycemic index differs by regimen     or diagnosis. In this pilot study up to 42 youth with type 1 diabetes or impaired glucose     metabolism (elevated fasting glucose, insulin resistance, or type 2 diabetes) will     participate in 5 days of continuous blood glucose monitoring during which they will receive     both low and high glycemic index meals. Children will be provided with 1 full day of low     glycemic index meals and 1 full day of high glycemic index meals in a supervised setting in     randomized order. Each of these test days will be preceded by a standard evening meal and     snack. Continuous blood glucose monitoring will also be conducted during regular food intake     ad libidum away from the clinic, as well as during one day of instructed low glycemic meals     at home. All food intake, insulin, and blood glucose self-monitoring will be recorded. While     in the clinic, measures of satiety and acceptability of the food will also be obtained. Data     analysis will include indices of blood glucose levels and variability.   "
206109|NCT00545740|"     The purpose of this study is to determine whether SPD476 is effective in reducing recurrence     of diverticulitis.   "
206110|NCT00545753|"     A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse,     under actual use conditions in subjects 6 months of age or greater who are infested with     Pediculosis capitis (human head lice).   "
206111|NCT00545766|"     Currently, there are no established 2nd-line or salvage chemotherapy regimens for patients     with HRPC, many of whom retain an excellent performance status. The antitumor characteristics     and toxicity profile of vinflunine make it an ideal agent to be investigated in this setting.     In this Phase II trial, we plan to evaluate the efficacy, toxicity, and feasibility of     administering IV vinflunine at a dose of 320 mg/m2 q3w as salvage chemotherapy in patients     with HRPC. The patients will be evaluated for response, survival, and toxicity. If     significant antitumor activity is demonstrated, further evaluation of this agent either alone     or combination regimens and at earlier stages of disease will be indicated.   "
206112|NCT00545779|"     This single arm study will assess participant preference for monthly Bonviva, versus daily or     weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis.     Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or     risedronate) will answer a questionnaire to identify participants who may benefit from a     monthly Bonviva regimen. Eligible participants will then discontinue their present     bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning     and end of Bonviva treatment, all participants will complete an Osteoporosis Patient     Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the     target sample size is 500+ individuals.   "
206113|NCT00545792|"     This research study is evaluating a drug called avastin in combination with standard     radiation as a possible treatment for treatment for recurrent pelvic-confined gynecological     cancer (i.e. endometrial, cervical, vulvar, ovarian or vaginal cancers).   "
206114|NCT00545805|"     The intraabdominal fat is associated with insulin resistance, a condition that is in the     basis of diabetes, metabolic syndrome and some cardiovascular diseases. It is not clear     whether it is the origin of it or a surrogate marker only. We intend to compare the effects     of bariatric surgery with versus without omentectomy in morbidly obese people intended to go     through bariatric surgery, accessing insulin sensitivity by metabolic tests.      If the visceral fat is causative of insulin resistance, its surgical removal (omentectomy)     might lead to improvement of insulin action, as seen in animal studies and in one study with     morbidly obese human volunteers.   "
206115|NCT00545818|"     The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for     rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long.     The primary hypothesis is that the alteration in bone level is equal in patients randomized     to 6 mm as to patients randomized to 11 mm implants.   "
206116|NCT00545831|"     Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal     disease leading to chronic malabsorption or obstruction, whatever the aetiology.     Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent     complication of patients with HPN and an important cause of morbidity and mortality in these     patients. Moreover, CRBSI often recur after a first treatment of the catheter with a     combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. In     more than 50 % of the cases, another CRBSI will occur in a median delay of 5 months.      The aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis     on CRBSI recurrence in HPN patients.      Study population is separated in 2 groups, the first one receiving the Taurolock and the     second one receiving a placebo. This is a randomized double-blind six-month study.   "
206117|NCT00545844|"     Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both     uncontrolled asthma and allergic rhinitis.   "
206118|NCT00545857|"     A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes     mellitus.   "
206119|NCT00545870|"     Treatment of diabetic macular edema with perifoveal focal/grid laser coagulation was found to     be effective saving the visual acuity only in 50% of patients and only 3-14% of treated     patients had an improved visual acuity postoperatively. The decent results of     lasercoagulation are associated with potential side effects, as focal scotomas, change of     color discrimination and development of epiretinal gliosis. The frequency of perifoveal laser     treatments is anatomically limited in case of diabetic macular edema: after application of     about 350 coagulates there is no possibility to repeat the laser treatment perifoveolar     without creating confluent lasercoagulates and causing significant scotomas. In case of     persistence of edema in spite of complete perifoveal grid coagulation, no standard therapy     exists. Some previous studies investigated the effect of steroids in patients with diabetic     macular edema unresponsive to grid laser photocoagulation, but the benefit on the visual     acuity was only temporary and the intravitreal application was associated with significant     side effects as cataract progression (up to 50%) and ocular hypertension (up to 20%).      In the Diabetic Retinopathy Study the 4-years rate for severe vision loss in patients with     high-risk retinopathy was 20.4 %. In cases of proliferative retinopathy, panretinal (scatter)     photocoagulation can reduce the risk for development of high-risk retinopathy by 50% over 6     years. When panretinal lasercoagulation is initiated, about 2000 laser spots are equally     distributed in all four quadrants. Since panretinal photocoagulation bares risks like loss of     field of vision, central vision reduction and loss of colour vision, this treatment can not     be continued unlimited.      In cases of persisting neovascularisations in spite of panretinal photocoagulation, no     evidence based therapy exists. There is a high risk for intravitreal bleeding, rubeosis,     secondary glaucoma with severe vision loss. When fibrovascular proliferation leads to retinal     detachment, vitreo-retinal surgery might be indicated.      Now we know that vascular endothelial growth factor (VEGF) is the major angiogenic stimulus     responsible for increase of vasopermeability, cellproliferation and angiogenesis in diabetic     retinopathy (DRP). Several studies, evaluating VEGF levels in vitreous, have indicated a role     for VEGF in diabetic macular edema: vitreous samples of patients with diabetic macular edema     contain elevated VEGF concentration and VEGF injected in experimental studies results in     breakdown of the blood-retina barrier.      There is increasing evidence for a therapeutic role of anti-VEGF drugs not only in     age-related macular degeneration but also in other diseases as in diabetic macular edema.     Intravitreal injections have become the most favored treatment procedure for administering     anti-VEGF drugs.      The side effects and the decent results of laser treatment on the visual acuity in diabetic     macular edema led to studies using anti-VEGF therapy. Unpublished study results on the     aptamer pegaptanib (Macugen™) are promising. A study using the antibody fragment Ranibizumab     (Lucentis™) in patiens with diabetic macula edema is in progress. Ranibizumab is now approved     to be used as an intravitreal injection.      Currently there is one additional anti-VEGF drug already on the market: Bevacizumab     (Avastin™), which has approved as intravenous infusion for the treatment of metastatic     colo-rectal cancer. Previous studies have shown that systemic use of Bevacizumab (Avastin™)     can obtain very promising results on patients with choroidal neovascularisation (CNV) by     age-related macular degenetration. This drug, a monoclonal full-length antibody, designed to     bind all isoforms of VEGF is a large molecule. But case reports in patients with CNV caused     by age-related macular degeneration and with macular edema from central retinal vein     occlusion indicate that intravitreally given Bevacizumab (Avastin™) is effective in diseases     originating from the choroids and the retina, too. These findings imply a sufficient     penetration of the retina by Bevacizumab (Avastin™).      Based on these new findings and the important role of VEGF in diabetic retinopathy, we     propose a pilot study for treatment of persistent diabetic macular edema or persisting active     neovascularistaions following lasercoagulation with intravitreally administered Bevacizumab     (Avastin™) or Ranibizumab (Lucentis™).   "
206120|NCT00545883|"     The aim of this study is to gather epidemiological data in a population of GERD patients in     primary care with a history of erosive esophagitis (less than or equal to 3 years).   "
206156|NCT00546403|"     The purpose of this study is to test the effect of modafinil on the negative symptoms, such     as blunted affect and social withdrawal, of schizophrenic patients and to determine     modafinil's effect on excessive daytime sleepiness. A secondary purpose of the study is to     examine the effect of modafinil on cognitive functioning of schizophrenic patients.   "
206157|NCT00546429|"     The purpose of this study is to monitor trochanteric fracture healing and review the     performance of the ATN system.   "
206158|NCT00546442|"     To evaluate the effect of treatment of insulin resistance in the response of chronic     hepatitis C treatment, mesure as HCV-RNA negative at week 72.      4.3.2 Objetivos secundarios To evaluate the efficacy and safety of treatment with metformine     to erradicate the insulin resistance of patients with chornic hepatitis C genotype 1 measure     as HOMA-IR < 2.   "
206121|NCT00545896|"     Chronic soft tissue wounds represent a difficult problem for patients and doctors as well.     Chronic wounds can be caused by internal and dermatological diseases like venous ulcers as a     consequence of venous insufficiency, arterial ulcers as a consequence of peripheral occlusive     vascular disease, the diabetic foot stemming from diabetes and other pathologies. A different     reason for chronic wounds could be prior traumatic injuries (war wounds, traffic     accidents)not showing a tendency to heal after surgical repair.      The primary goal in the treatment of chronic soft tissue wounds is to obtain wound closure.     Usually necrotic tissue is debrided, i.e. surgically removed, to assess the full extent of     the damage, to detect underlying abscesses or other pathologies causing the non-healing of     the wound. Wet - to - wet dressings are primarily applied to induce a healing process. As     second line attempts to obtain closure special dressings like semipermeable films, gels,     hydrocolloids and calcium alginates are applied. These expensive dressings are associated     with extended time periods of conservative treatment until closure can be observed.      A third line after failure of nonoperative treatment is the application of skin graft. This     involves the operative and anesthesiological risk for an already health wise compromised     patient with little to no physiological reserve. One should not forget that the majority of     patients presenting at outpatient clinics with chronic soft tissue wounds are the elderly     with/without disabling comorbidities.      The use of extracorporeal shockwaves (ESW) for clinical applications was introduced in     central Europe more than two decades ago. Extracorporeal shockwave therapy (ESWT)is used in     the fields of urology, orthopedic surgery, trauma surgery. ESW are associated with the     induction of neovascularisation and with mechanical stimuli causing proliferation of a large     number of cells including osteoblasts (Martini L., J Trauma 2006). The exact effects of ESW     on human cells are currently studied in several centers worldwide. The application of ESWT in     the above mentioned fields of medicine proved safe, reliable and almost complication-free.      Our center's experience with ESWT in trauma surgery (Schaden W., Clin. Orthop 2001)and the     observation that not only the traumatic condition (fracture non-union, etc.), but also the     surrounding tissue showed favorable tissue healing after ESWT, leads to our hypothesis that     ESWT might be beneficial for the much larger number of chronic soft tissue wounds. The     investigators anticipate to induce complete wound healing in a number of defined     clinical/pathological conditions by ESWT. At the same time efficacy and safety of ESWT will     be investigated.   "
206122|NCT00545909|"     This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling     and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in     women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group     which receives bone marker feedback or 2)a group which does not receive feedback on the     results. The study will also assess patient satisfaction with treatment with once monthly     Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size     is 500+ individuals.   "
206123|NCT00545922|"     The purpose of this study was to examine the efficacy of manualized, short-term group     cognitive behavioral therapy for COPD patients suffering from clinically significant symptoms     of anxiety and/or depression.   "
206124|NCT00545935|"     The purpose of the study is to investigate the safety and efficacy profile of a new     paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African     children with uncomplicated falciparum malaria.   "
206125|NCT00545948|"     This study assigned subjects to either cisplatin/vinorelbine or cisplatin/pemetrexed     chemotherapy using a genomic based expression profile to determine chemotherapy sensitivity     in completely resected early stage non-squamous non-small-cell lung cancer (NSCLC). The     vinorelbine-sensitive tumors group received Vinorelbine followed by cisplatin, while the     pemetrexed-sensitive tumors group received pemetrexed followed by cisplatin. The primary     objective of this trial was to determine whether genomic-based adjuvant chemotherapy     treatment increased the 2-year progression-free survival rate in completely resected patients     with NSCLC compared to historic controls. Secondary objectives included: 1) estimation of the     percentage of completely resected NSCLC tumors that can be adequately analyzed and used to     direct specific adjuvant chemotherapy; 2) estimation of the proportion of patients who are     assigned to treatment with vinorelbine and pemetrexed; 3) evaluation of drug sensitivity     patterns of cisplatin and pemetrexed in both treatment arms; 4) description of the overall     median survival experience of treated patients; and 5) assessment of patient understanding     and perceptions of participating in a clinical trial evaluating cancer genomics for adjuvant     treatment of early stage lung cancer.   "
206126|NCT00545961|"     The purpose of this study is to find out whether the children with respiratory infection and     the presence of pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the     nasal middle meatus benefit from antimicrobial treatment.   "
206127|NCT00545974|"     The primary objective of the study is to determine whether memantine is effective in slowing     the rate of behavioral decline in frontotemporal dementia.      The secondary objective of the study is to assess the safety and tolerability of long-term     treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia     (SD). To determine whether memantine is effective in slowing the rate of cognitive decline in     frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of     parkinsonism in frontotemporal dementia.      The tertiary objective of the study is to determine whether treatment with memantine affects     changes in weight   "
206128|NCT00545987|"     This study will test the safety of a HIV DNA vaccine after it is injected into your muscle     using an electroporation device (TriGrid™ Delivery System made by Ichor Medical Systems), and     will test the ability of the vaccine to help your body make antibodies and T-Cells.      In this study, we would like to learn about the effects that electroporation of the HIV DNA     has on you and your immune system.   "
206129|NCT00546000|"     A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate,     0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic     dermatitis.   "
206130|NCT00546013|"     Conflicting results have been reported concerning the association of pseudoexfoliation     syndrome (PXF) and abdominal aortic aneurysms (AAA). Schumacher et al. reported an     association between AAA and PXF, with no consideration of grade. However, a later study did     not confirm the association between AAA and PXF. The present study aimed at comparing the     relative prevalence of PXF in patients suffering from AAA and in age-matched hypertensive     patients.   "
206159|NCT00546455|"     Many metabolic complications of obesity are a consequence of abnormal responses of the liver,     muscle, and fat to insulin actions. Fenretinide may improve the effects of insulin,     preventing metabolic complications.   "
206178|NCT00546702|"     To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in     terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR     1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26,     blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes     mellitus receiving HMR 1964 and insulin glargine.   "
206179|NCT00546715|"     The primary purpose of this study is to evaluate the safety profile and tolerability of     single oral doses of daclatasvir in subjects with chronic hepatitis C infection   "
206131|NCT00546065|"     This is a prospective, randomized, controlled, double-blinded, multi-center trial in a     parallel-group design. Aim of the study is the evaluation of tumor-free survival after     ablation (by APC, argon plasma coagulation) of Barrett's mucosa plus esomeprazole versus     surveillance without ablation in patients cured from Barrett's cancer combined with     randomization of esomeprazole vs placebo for symptomatic reflux control after successful     ablation of Barrett's mucosa .      There are two hypotheses: (1) Consecutive thermal ablation of metaplastic, non-neoplastic     long segments of Barrett's esophagus (>2cm)plus esomeprazole after successful endoscopic     therapy of mucosal cancer by means of ER will decrease the incidence of secondary cancer     (local recurrence and metachronous cancer) by a minimum of 50% compared to acid suppression     alone without ablation within a 5-years follow-up (primary endpoint). (2) After successful     ablation of Barrett's esophagus patients need ongoing acid suppression therapy for medical     control of their underlying reflux disease (secondary aim of the study).      Duration of the study:      Patient recruitment period: 3 years. Follow-up period: 5 years. Total duration: 8 years. The     study is already in the recruitment period.   "
206132|NCT00546078|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. This study will further evaluate induction of immune memory and     anamnestic responses in women who previously took part in the primary study (580299/001) and     follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the     primary study and participation in the follow-up study lasted approximately 6 years. In the     primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints     and had sustained antibody responses to both vaccine types over at least 5.5 years of     follow-up. All subjects from North American study sites that completed the follow-up study     will be invited to take part in the current study. The study will evaluate the safety and     immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been     immunologically primed in the primary study.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
206133|NCT00546091|"     This study will explore the uses of three noninvasive imaging techniques-thermography, laser     Doppler imaging, and multispectral imaging-to test the blood flow of healthy volunteers. By     comparing these three techniques, researchers will be able to train these imaging systems to     better evaluate skin types and blood flow. The study will also test computer programs that     have been developed to correct for the effects of curvature and body hair on the images.      Healthy volunteers must be older than 18 years of age and may not have had a history of     malignant tumors, skin disease, or vascular disease.      Participants will undergo the following procedures on an outpatient basis:      Three different types of images taken of the participant s forearm        -  Thermography infrared thermal imaging to map skin temperature        -  Laser Doppler imaging low-powered laser imaging to map blood flow in the skin        -  Multispectral imaging near-infrared light imaging to measure total blood flow and oxygen          levels in the skin      A reactive hyperemia experiment, in which multispectral images will be taken of the     participant s forearm during and after the use of a blood pressure cuff      A hair removal experiment, in which images will be collected of the participant s forearm in     separate scans done before and after the hair is removed with a topical hair removal solution      The entire series of exams will take approximately one hour to perform.   "
206134|NCT00546104|"     The purpose of this study is to find out if dasatinib will safely reduce the size or spread     of your tumor.   "
206135|NCT00546117|"     This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid     in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole)     will increase the rate of resolution of chronic middle ear fluid in children.   "
206136|NCT00546130|"     The purpose of this study is to examine whether setting test groups of cisplatin + irinotecan     + Krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy +     chemotherapy also allowed) combined with Krestin as second-line treatment after exacerbation     and comparing with historical control or community control is appropriate as the protocol and     regimen for the phase III clinical trial on extensive-stage disease (ED) small cell lung     cancer.   "
206137|NCT00546143|"     This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild     to moderate allergic asthma   "
206138|NCT00546156|"     Dose dense chemotherapy, which is the term for Adriamycin and Cyclophosphamide (AC) followed     by Taxol chemotherapy given every two weeks, is the standard chemotherapy for the treatment     of ER+ or PR+ breast cancer. In this trial, the standard chemotherapy is being combined with     bevacizumab. Bevacizumab is an antibody which works differently from the way other     chemotherapy drugs work. Bevacizumab slows or stops cell growth in cancerous tumors by     decreasing the blood supply to the tumors by binding to a substance found on cancer cells     called VEGF (vascular endothelial growth factor). Bevacizumab is approved by the FDA for the     treatment of colorectal cancer and lung cancer. However, it is not approved for the treatment     of breast cancer. Another goal of this research is to determine whether we can develop a way     to identify tumors that will respond well to this study treatment.   "
206139|NCT00546169|"     -  Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute)        -  Evaluation of TachoSil in laparoscopic cholecystectomy        -  Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy        -  Pharmaco-economic evaluation        -  Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany          (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it          seems urgent to record data about usage of TachoSil in such procedures. For the time          being TachoSil is applied in about 2% of the gall bladder procedures.      Aim is to evaluate a possible patient and procedure profile where TachoSil is most     beneficial.   "
206140|NCT00546182|"     We hypothesized simvastatin may reduce adiponectin levels and insulin sensitivity in     overweight hypercholesterolemic patients.   "
206175|NCT00546663|"     This is an open-label pilot study of the safety and tolerability of 7% hypertonic saline     inhaled twice daily for 14 days in infants with CF, 12 to 30 months of age.   "
206176|NCT00546676|"     To determine the clinical effectiveness of telithromycin in the treatment of either CAP or     AECB in a large population of ambulatory adult patients in a community-based setting.   "
206379|NCT00543023|"     To compare the effect of treatment with teriparatide with that of salmon calcitonin in     postmenopausal women with osteoporosis.   "
206141|NCT00546195|"     This study will examine the response of white blood cells to bacterial infection in blood     taken from the umbilical cords of newly delivered infants. The blood samples will be taken     from both male infants who were carried to term and male infants who were born prematurely,     and genetic studies will compare these blood samples to samples drawn from healthy adult male     volunteers. The study is designed to look at the ways in which the immune systems of newborn     infants respond to bacterial infection.      Participants in this study will be pregnant Chinese women admitted to the labor ward of the     Prince of Wales Hospital (Sha Tin district of New Territories, Hong Kong SAR) for normal     spontaneous delivery. Those with known blood-borne infectious diseases such as HIV and     hepatitis B will be excluded from this study.      Cord blood and placenta samples will be collected after the completion of delivery. The     samples collected for this study will be restricted to male newborns. A comparison group of     blood samples will be drawn from healthy male adults between 25 and 35 years of age....   "
206142|NCT00546208|"     This observational study is aimed at exploring bladder function following temporary     unilateral low loop cutaneous ureterostomy carried out in newborns suffering from severe     congenital hydro-ureteronephrosis   "
206143|NCT00546221|"     The investigators want to find out if their specially designed exercise programme will be     more successful at helping women with depression to feel better than a basic programme will,     by measuring the effect the programme has on mood, physical health, and social wellbeing.     Their specially designed exercise programme will involve physical exertion at the     participants' chosen level of intensity (how hard the body has to work during exercise), and     will include motivational support. By contrast, the basic exercise programme will be at an     intensity recommended by national guidelines, of the type that may be prescribed by a general     practitioner (GP), and will include no extra motivational support.   "
206144|NCT00546234|"     The study's research questions concern the appropriateness of use of tiotropium for patients     with asthma who are current smokers. It is suggested that patients with asthma who smoke, may     in fact share similarities with patients with chronic obstructive pulmonary disease (COPD).     Because of this, the study will determine whether this sub-group of patients would in fact     benefit from therapy currently approved and marketed for COPD patients.   "
206145|NCT00546247|"     The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493)     in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate     (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian,     renal or breast cancer (in Phase 2 portion).   "
206146|NCT00546260|"     Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous     intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)   "
206147|NCT00546273|"     The aim of this study is to evaluate the safety of a new vaccine against Tuberculosis (RUTI)     when administered to healthy adult volunteers, compared to placebo; and determine its safe     dosage range. An initial evaluation of immune responses to the vaccine compared to placebo     will also be undertaken.      In the present Phase I clinical trial, four increasing doses of RUTI will be tested, the     groups composed by 6 volunteers each. (Total of 24 volunteers). The escalation to a new dose     to test will be done after the safety of the previous dose has been ensured.      For each dose of FCMtb to test, each volunteer will be inoculated twice (at day 0 and day 28)     with RUTI (4 volunteers) or placebo (2 volunteers) and will be followed-up up to 25 weeks     from the first inoculation. The global length of the study will be approximately 15 months.   "
206148|NCT00546286|"     Evaluate the effectiveness of dorzolamide-timolol (Cosopt®) as first line therapy in reducing     intraocular pressure in patients with untreated Open angle glaucoma (OAG) or Ocular     hypertension (OH).   "
206149|NCT00546299|"     Several studies have described the use of supplemental oxygen during exertion or activities     of daily living (ambulatory oxygen) in study populations that have different characteristics.     This report, based on specialized randomized controlled trials, characterizes ambulatory gas     usage among patients with COPD who experience low oxygen levels during activities.   "
206150|NCT00546312|"     The purpose of this study is to evaluate the safety and efficacy of endovascular repair,     using the Thoracic EXCLUDER Endoprosthesis, when used in the treatment of descending thoracic     aortic disease as indicated by radiological testing at time of discharge, and 1, 6, 12 months     and annually following implantation, and to determine the proportion of patients who     experience adverse events during and after the implantation procedure, including     disease-specific and overall mortality rates.   "
206151|NCT00546325|"     Primary:      To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are     overweight or obese (Body Mass Index (BMI) > 27 kg/m² and BMI < 40 kg/m²), have uncontrolled     HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti     Diabetic medications - Metformin (Met) and Sulfonylurea (SU).      Secondary:      To assess the effects of rimonabant on Anthropometric measures, Glucose measures, Lipid     measures, Other measures and changes in quality of life   "
206152|NCT00546351|"     SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial     is to assess safety and tolerability of long-term exposure of lacosamide (previously referred     to as SPM 927) in subjects with painful distal diabetic neuropathy.   "
206153|NCT00546364|"     The purpose of this study is to assess the effect of ixabepilone plus capecitabine or     docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in     women. The safety of this combination therapy will also be evaluated.   "
206154|NCT00546377|"     RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and     mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can     block cancer growth in different ways. Some block the ability of cancer cells to grow and     spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. Giving pentostatin together with combination chemotherapy and rituximab may kill more     cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of mitoxantrone     when given together with pentostatin, cyclophosphamide, and rituximab and to see how well it     works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell     cancer.   "
206160|NCT00546468|"     Rationale: For the treatment of early gastric cancer (EGC) in the distal portion of the     stomach, subtotal gastrectomy and lymph node dissection has been a standard operation. With     the increasing tendency toward minimally invasive surgery, there has been an effort to apply     minimally invasive techniques to the treatment of EGC. Laparoendoluminal mucosectomy and     lesion-lifting gastric wedge resection have been developed for this purpose. However, these     methods have the disadvantage of limited indications according to the size, shape and depth     of invasion. Kitano et al. performed the first laparoscopy-assisted subtotal gastrectomy with     lymph node dissection and manual anastomosis with anterior wall lifting method for a patient     with EGC. In 1995, Uyama et al. and Nagai et al. performed laparoscopy-assisted subtotal     gastrectomy with lymph node dissections using an automatic stapler instead of manual     anastomosis for the gastroduodenal anastomosis. It has been possible to maintain an adequate     distance from the lesion to the proximal and distal margins of resection, to perform radical     lymph node dissection, and to achieve excellent postoperative recovery. However, there is a     very limited evidence of superiority of laparoscopic gastrectomy over open surgery. There is     only one interim report of randomized clinical trial of comparing laparoscopic gastrectomy     and open gastrectomy. A well-designed clinical study to prove the benefit and safety is     definitely needed Objective: to compare Laparoscopy - assisted Distal Gastrectomy (LADG) with     Open Distal Gastrectomy (ODG) in terms of survival, recovery, pain, complications, and     quality of life (QOL) Hypothesis: LADG is beneficial in QOL, pain, recovery, complications     while maintaining equivalent survival with ODG   "
206161|NCT00546481|"     This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the     correction of anemia in patients with chronic kidney disease who are on dialysis. Patients     will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin     3 times per week i.v. according to approved treatment recommendations. The anticipated time     on study treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
206162|NCT00546494|"     This is a study to determine the utility of Effexor® (venlafaxine) in achieving response,     including time to response, maintaining remission, and time to remission as measured by the     17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor®     (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D.   "
206163|NCT00546507|"     The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical     diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of     the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than     celecoxib.   "
206164|NCT00546520|"     Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma. In this study the     effect of ciclesonide on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and     induced sputum inflammatory biomarkers will be evaluated.   "
206165|NCT00546533|"     To assess the efficacy of etanercept 25 mg administered subcutaneously twice-weekly for 12     weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or     inappropriate.   "
206166|NCT00546546|"     Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's     disease: early immunosuppressants (prescription within the six first months following     diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid     failure, in a selected group of patients being at high risk of disabling course. The     hypothesis is that immunosuppressants given early may improve the disease course during the 3     following years in this subset of patients.   "
206167|NCT00546559|"     The investigators hypothesized simvastatin and pravastatin may have differential metabolic     effects in hypercholesterolemic patients.   "
206168|NCT00546572|"     This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC     and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5     years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of     13vPnC 1 year after the initial dose of study vaccine.   "
206169|NCT00546585|"     The purpose of this study is to evaluate the safety, any adverse events or side effects, and     the body's immune response to an experimental flu vaccine [Inactivated Influenza A/H7N7     Vaccine] being given in increasing doses. Researchers will try to find the smallest dose of     flu vaccine needed to cause antibody responses against the flu virus in both single and     repeat doses. The study will enroll 125 healthy adults ranging in age from 18 to 40 years     old. Subjects will be given 2 doses of the vaccine 28 days apart. Study procedures will     include obtaining a medical history, physical exam, blood sample collections, and use of     patient memory aids. The volunteers will be in the study for about 7 months.   "
206170|NCT00546598|"     This study is being conducted to gather medium and long-term information regarding the     performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip     Prosthesis System.   "
206171|NCT00546611|"     Verruca vulgaris, otherwise known as the common wart, is caused by the human papillomavirus     (HPV). Common warts are generally located on the hands and feet, but can also occur elsewhere     (e.g., any areas of frequent contact). Common warts have a characteristic cauliflower-like     surface, are typically slightly raised above the surrounding skin and are generally diagnosed     by visual inspection.The treatment of warts poses a therapeutic challenge for physicians. No     single therapy has been proven effective at achieving complete remission in every     patient.This study will aim to evaluate an up-to a three-day course of therapy with 0.05%     PEP005 Topical Gel.   "
206172|NCT00546624|"     This study will determine the effectiveness of MK0777 GEM versus Lorazepam in the treatment     of patients with generalized anxiety disorder.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
206173|NCT00546637|"     To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement     when added to ongoing alpha blocker treatment.   "
206174|NCT00546650|"     The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently     approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and     to assess the bioavailability relative to the 6 mg subcutaneous injection.      The secondary objective is to evaluate the safety of NP101 in healthy volunteers.   "
240271|NCT00999960|"     To evaluate the clinical impact of an online video simulator during the learning period of     laparoscopic radical prostatectomy.   "
206180|NCT00546728|"     The purpose of this study is to compare the effects of exenatide versus metformin on vascular     health with chronic (3-month) therapy and during a 2-hour period following a meal in patients     with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater     degree compared to metformin.   "
206181|NCT00546741|"     The purpose of the study is to determine the effect of metformin on dapagliflozin exposure     and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally,     the safety and tolerability of dapagliflozin will be assessed in the presence and absence of     metformin in healthy volunteers   "
206182|NCT00546754|"     To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage     during a 3 months treatment.   "
206183|NCT00546767|"     The purpose of this study is to evaluate three methods of performing home-based assessments     in Alzheimer's Disease (AD) prevention trials. The initial in-person assessment will be done     in the clinic or at home.   "
206184|NCT00546780|"     This is a phase 3, open label trial for patients with multiple myeloma in first relapse.     Trial will compare tanespimycin (KOS-953), in combination with a fixed dose of bortezomib     versus bortezomib alone.   "
206185|NCT00546793|"     The purpose of this study is to determine if a subcutaneous (SC) dosing schedule of     veltuzumab can be established in NHL or CLL patients and to confirm the safety and efficacy     of veltuzumab that was previously established when administered intravenously.   "
206186|NCT00546806|"     Whiplash is the most common traffic injury, affecting 83% of people involved in motor vehicle     collisions. People with whiplash injuries often experience pain and disability that can last     for a long period. This may subsequently lead to an increased use of the health care system.     Preventing chronic symptoms is a priority for clinicians, insurers, and policy makers.     However, there are very few factors that can be changed by treatment to prevent prolonged     symptoms. Providing effective care at the appropriate time is one aspect that can be changed     and needs to be studied. To date, no randomized clinical trials have investigated the     effectiveness of multidisciplinary rehabilitation programs for the management of patients     with whiplash-associated disorders. Additionally, there is no evidence to suggest whether     rehabilitation programs are superior to physician-based care at improving whiplash-associated     symptoms. Thus, there is a need for a randomized trial to determine what program results in     the best outcomes for patients.      The purpose of this study is to compare three programs of care that are currently available     in Ontario for the management of patients with Whiplash-associated disorders.      The results of this study will demonstrate which of three programs of care is superior in     improving the physical and mental health of patients with whiplash-associated disorders. The     results will help guide the development and implementation of effective and cost-effective     programs of care by informing clinicians, insurers and government on the best rehabilitation     options for patients with whiplash injuries.   "
206187|NCT00546819|"     The purpose of the study was to assess the safety, tolerability, and immunogenicity of     ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.   "
206188|NCT00546832|"     The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical     diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of     the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than     celecoxib.   "
206189|NCT00546845|"     This study is an investigator-initiated study. The study will be performed as a prospective,     randomized, controlled multi-center trial to evaluate the safety and efficiency of Xpert     stents compared to PTA in patients with chronic distal artery occlusions or stenosis     undergoing catheter revascularization. Patients will be eligible for randomization if they     are over 18 years old, if they undergo percutaneous catheter revascularization of an artery     below the knee stenosis/occlusion that is less than 15 centimeters in length. Up to two     vessels may be treated in this study. All lesions greater than 50% in the below the knee     artery region have to be treated either with PTA or stenting according to the randomization.   "
206190|NCT00546858|"     This study is important in urologic nursing since many patients have interstitial cystitis     (IC), a condition of frequency, urgency and pain affecting more than 1 million women in the     United States. The vulva may actually be the site of some of the reported pain in women with     IC, not the urethra or bladder. IC and vulvodynia can impact one's sexual functioning and     diminish one's quality of life.      The purpose of this two-part study is to identify and clinically confirm the presence of     vulvodynia in women diagnosed with Interstitial Cystitis (IC).   "
206191|NCT00546871|"     The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously     and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with     IGIV, 10% in subjects with primary immunodeficiency (PID) disorders.   "
206192|NCT00546884|"     The purpose of this study is to determine whether homeless individuals will complete a living     will and whether guidance enhances rates of completion and to see whether filling out a     living will has any impact on the care given at the end of life.   "
206193|NCT00546897|"     This study is designed to test the safety and efficacy of lenalidomide in older patients (age     > 60 years) with untreated acute myeloid leukemia without chromosomal abnormalities involving     5q.   "
206194|NCT00546910|"     This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter     trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6     through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an     inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured     during once or bi-weekly visits, three times per visit-day, by a computer based Continuous     Performance Test. Following an initial 3-28-day screening and washout phase, patients will be     assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week     atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7     week period at the target dose of 1.2 mg/kg per day.   "
206195|NCT00546923|"     To examine the efficacy and safety of venlafaxine XR in the treatment of physical and     emotional symptoms in patients with an operationally-defined diagnosis of multisomatoform     disorder (MSD).   "
206196|NCT00546936|"     The purpose of this study is to evaluate the change in visual activity of ranibizumab to     Photodynamic Therapy (PDT)in patients with choroidal neovascularization (CNV) secondary to     presumed ocular histoplasmosis   "
206197|NCT00546949|"     The purpose of this study is to compare two surgery methods on lumbar spinal stenosis:     minimal invasive decompression and X-stop. It is a prospective randomized multicenter study     including patients with lumbar spinal stenosis on one or two levels, and neurogenic     intermittent claudication. Effect assessment will include measures of pain and self-evaluated     health condition, a full economical evaluation, and areal measurements (MR imaging and     roentgen analyses)   "
206198|NCT00546962|"     The aim of this research study is to collect and store the specimens that are left over after     patients undergo tests ordered by their physicians. These specimens will be used at a later     time by researchers in the Pulmonary Division to develop a better understanding of pulmonary     diseases or for the development of new treatments. Typical research studies that will be     conducted on the stored tissue, fluid, or bacteria from the patient sample involve obtaining     bacterial cultures, measurement of inflammatory markers, and examination of the     characteristics of the tissue. Other similar tests may be done in the future; however, these     tests have not all been determined at this time. It is important to note that no genetic     testing will be performed on any samples that are obtained as part of this protocol.   "
206199|NCT00546975|"     Nutritional supplementation in postoperative recovery is still debated. Functional impairment     is known to develop both secondary to inflammatory processes or secondary to reduced     nutritional intake (e.g. disease induced anorexia). Since major surgery represents a     traumatic event, surgical patients are at increased risk of malnutrition due to starvation,     activation of neuroendocrine stress axis, inflammation and the subsequent increase in     metabolic rate. Gastrointestinal surgery in particular can create additional problems as it     often directly affects and limits dietary intake postoperatively and these effects frequently     continue after discharge. Whereas manifest malnutrition occurs in about 15% of general     surgical patients and in about 40% of oncology patients, postoperative weight loss of 5 to 9%     occur in all surgical patients during the first two months. Moreover studies have shown that     the nutritional status generally declines in hospital and both functional and nutritional     status deteriorate for two months after discharge in malnourished surgical patients.      Most studies that have investigated nutritional support in the surgical setting have     concentrated on perioperative or short term postoperative supplementation and focussed on     in-hospital infection and complication rate.      Hypothesis I:      Nutritional intake is decreased after surgery which results in an impaired nutritional status     which in turn is associated with a decreased functional status. Protein rich nutritional     supplementation is able to reverse nutritional depletion and restore functionality.      Hypothesis II:      Surgical stress leads to inflammation; inflammation - in addition to reduced nutritional     intake - impairs functional status and increases morbidity. Anti-inflammatory, protein rich     nutritional supplementation aims to prevent inflammatory complications and therefore improves     functional status and reduces morbidity. In patients with high risk for inflammation, a     higher effect of anti-inflammatory oral nutrition on recovery of functional status is     expected.      This study aims to determine whether 4 week oral nutritional supplementation and/ or     specialized nutrients is effective in restoring functional status and reducing morbidity in     surgical patients.   "
206200|NCT00546988|"     The study is evaluating whether risk-stratification by the means of a chromosomal aberration     provides a tool to discriminate between standard and high risk. Risk-adapted therapy is based     on allogeneic stem-cell transplantation for high-risk subjects instead of a second autograft     in patients with deletion of chromosome 13 who have an HLA-identical stem cell donor     available.   "
206201|NCT00547001|"     This study will evaluate whether there is a difference in the proportion of women who report     a worsening severity of their hot flashes between three tapering schedules for one accepted     HT/ET regimen. Secondarily, we hope to evaluate whether there is a difference in the     frequency (number of occurrences per week), severity (defined as a subjective scale mild,     moderate, or severe), and Severity Index (SI, equaling the product of both) of hot flashes     between three tapering schedules for one accepted HT/ET regimen.   "
206202|NCT00547014|"     Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or     capsule. Another purpose is to determine how the drug enters and leaves the blood stream and     body tissues over time.   "
206203|NCT00547027|"     The purpose of this study is to determine the effects of a tailored, print-based physical     activity intervention for patients diagnosed with type 2 diabetes.   "
206204|NCT00547040|"     The purpose of this study is to determine the:        -  Natural history of calcification posttransplantation        -  Natural history of BMC following renal transplantation        -  Reverse correlation between calcification score and aortic calcifications following          renal transplantation        -  Correlation of IMT, BMC, PWV and biochemical variables        -  Correlation of IMT, BMC, PWV, biochemical variables and outcome        -  Predictors of CV disease after transplantation        -  Predictors of IMT progression, BMC loss and PWV progression after renal transplantation   "
206205|NCT00547053|"     The purpose of this research study is to determine if multiple doses of two inhaled drugs     will help Cystic Fibrosis patients whose lungs are infected with a bacteria called     Burkholderia dolosa. The names of these drugs are tobramycin solution for inhalation and     amiloride solution for inhalation. Currently, treating patients with Burkholderia dolosa     infections is challenging because the bacteria is resistant to antibiotics. Therefore,     researchers are looking for drugs which, when taken with an antibiotic, will help the     antibiotic to work more effectively.   "
206206|NCT00547066|"     This trial will study different dose levels of hA20 (IMMU-106) to see if they are safe and     effective for treating ITP.   "
206207|NCT00547092|"     To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after     treatment with both drugs.   "
206208|NCT00547105|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Stereotactic body radiation therapy may be able to send x-rays     directly to the tumor and cause less damage to normal tissue. Giving erlotinib together with     stereotactic body radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving erlotinib together with stereotactic     body radiation therapy works in treating patients with locally advanced or metastatic     non-small cell lung cancer.   "
206223|NCT00547326|"     Children with otitis media with effusion will be treated with osteopatic cranial techniques     or with a placebo treatment. Before and after the treatment audiometric and tympanometric     measures will take place. This procedure will be repeated 3 times, once a week and every     session will last for 30-45 minutes. The fourth week, only audiometry and tympanomtry will be     done.   "
206224|NCT00547339|"     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the     tumor and cause less damage to normal tissue.      PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic     body radiation therapy and to see how well it works in treating patients with prostate     cancer.   "
206225|NCT00547352|"     To determine if men with problems getting and keeping an erection prefer treatment with     tadalafil or sildenafil.   "
206380|NCT00543036|"     Evaluation of efficacy and safety of H-coil deep transcranial magnetic stimulation 9 week     treatment trial for cannabis addiction as assessed by measures of drug intake and craving.   "
206209|NCT00547118|"     1) To examine the efficacy of rimonabant in decreasing weight and metabolic     parameters/cardiovascular disease risk in people with schizophrenia receiving second     generation antipsychotics 2) To examine the safety and tolerability of rimonabant as an     adjunctive agent for decreasing weight and metabolic risk in people with schizophrenia 3) To     examine the efficacy of rimonabant for neurocognitive impairments in people with     schizophrenia treated with second-generation antipsychotics (secondary outcome) 4) To examine     the efficacy of rimonabant for patient perceived health outcomes and quality of life     (secondary outcome) 5) To test the effect of rimonabant on cigarette smoking, nicotine     dependence and nicotine craving in people with schizophrenia 6) To examine the effects of     rimonabant on food satiety in people with schizophrenia      There is an increasing awareness of the problem of metabolic issues in people with     schizophrenia and renewed focus on physical health care for this population. There is     under-treatment, in general, of medical conditions in people with schizophrenia, and     increased mortality from natural causes. People with schizophrenia are at risk for developing     obesity due to many factors including inactive lifestyle, poor dietary choices, and side     effects of the commonly used atypical antipsychotics. Metabolic syndrome has been discussed     in the cardiology and endocrinology for over two decades, but its prevalence in the mentally     ill is only now being fully realized. Diabetes mellitus may be twice as prevalent among     patients with schizophrenia as in the general population and metabolic syndrome is probably     even more prevalent than diabetes among people with schizophrenia. There is now an     opportunity to address this serious problem. A new drug, rimonabant, has recently been     approved in several European and Latin American countries. This drug represents the first of     a new class of psychoactive drugs witch may improve metabolic problems through decreasing     appetite drive. This may also help decrease the drive for cigarette use, which is also a     great problem for people with schizophrenia. Is this a safe and effective treatment in this     population? This study proposes to test this question in a rapid study, which will develop     the basis for future work in this important area.   "
206210|NCT00547131|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Collecting fluid samples through a catheter may help doctors find out how well temozolomide     spreads throughout the brain.      PURPOSE: This clinical trial is studying temozolomide in treating patients with primary brain     tumors or metastatic brain tumors.   "
206211|NCT00547144|"     To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate     patients with pancreas cancer   "
206212|NCT00547157|"     The purpose of this study is to estimate, with pre-specified precision, the difference in     local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or     panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous     cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this     trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.   "
206213|NCT00547170|"     This study is a randomized, double-blinded, controlled trial comparing two regimens of     doxycycline for the prevention of infection after surgical abortion. One thousand women     undergoing surgical abortion in the first trimester will be enrolled from the clinic at Tu Du     Hospital, Ho Chi Minh City, Vietnam. The standard regimen has been 100 mg twice daily for 5     days after the abortion. Subjects will be randomized to the standard regimen or to take 200     mg doxycycline pre-operatively. Subjects found to have a positive Chlamydia EIA test will     receive a 7-day course of doxycycline regardless of study group. Subjects will complete     questionnaires of symptoms, including nausea and emesis in the recovery room after the     procedure and at a single follow-up visit two weeks later. The primary outcome will be     infection after abortion, defined below. Analyses will be performed including and excluding     Chlamydia-positive subjects. Secondary outcomes will be the proportion with nausea, emesis,     and other side-effects.   "
206214|NCT00547183|"     Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men     with diabetes mellitus who have problems getting and maintaining an erection.   "
206215|NCT00547196|"     RATIONALE: Giving chemotherapy with or without total-body irradiation before a donor     umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It also     helps stop the patient's immune system from rejecting the donor's stem cells. When the stem     cells from a donor are infused into the patient they may help the patient's bone marrow make     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted     cells from a donor can make an immune response against the body's normal cells. Giving     cyclosporine and mycophenolate mofetil before and after transplant may stop this from     happening.      PURPOSE: This clinical trial is studying how well four different chemotherapy regimens given     with or without total-body irradiation before umbilical cord blood transplant work in     treating patients with relapsed or refractory hematologic cancer.   "
206216|NCT00547209|"     The main objective of the study is to analyze the influence of nitrous oxide on propofol and     remifentanil requirements.   "
206217|NCT00547235|"     RATIONALE: Collecting the T cells from a donor and transplanting them into a patient may be     effective treatment for immunodeficiency syndrome and CMV infection.      PURPOSE: This clinical trial is studying the emergency use of adoptive immunotherapy with     CMV-specific T cells after donor bone marrow transplant of an infant with immunodeficiency     syndrome and CMV infection.   "
206218|NCT00547248|"     The purpose of this observer blind study is to assess the safety in terms of fever >39°C     (rectal temperature) and the immunogenicity in terms of antibody response following a booster     vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children     previously primed with the same vaccines including a pneumococcal conjugate vaccine     co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and     OPV or IPV vaccines. Subjects participating in this study should have received three doses of     pneumococcal conjugate vaccine in the primary study.      This protocol posting deals with objectives & outcome measures of the booster phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT00344318)   "
206219|NCT00547261|"     The purpose of this study is to determine the maximally tolerated dose and the dose limiting     toxicity of this antimitotic, tubulin binding investigational drug for those patients who     have failed standard anticancer treatments.   "
206220|NCT00547274|"     The purpose of the study is to compare the lipid-altering effects of MK0767, glipizide, and     pioglitazone after 12 weeks of treatment.      This is an early phase trial and some specific protocol information is in progress and not     publicly available at this time. (Full information is available to trial participants).   "
206221|NCT00547287|"     Study to determine if men from around the world prefer sildenafil to tadalafil.   "
206222|NCT00547300|"     The purpose of this study is to compare the tolerability of nebivolol to metoprolol ER in a     populatoin of patients with mild to moderate hypertension also receiving hydrochlorothiazide     (HCTZ)   "
206434|NCT00549393|"     The investigators propose to conduct a large clinical study to determine if daily bathing     with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated     infections in the Pediatric Intensive Care Unit (PICU).   "
206226|NCT00547365|"     RATIONALE: Antibodies, such as human immune globulin, can block the growth of abnormal cells     in different ways. Some block the ability of abnormal cells to grow and spread. Others find     abnormal cells and help kill them or carry cell-killing substances to them. Giving human     immune globulin may be effective in treating patients with primary amyloidosis that is     causing heart dysfunction.      PURPOSE: This phase I/II trial is studying the side effects and best dose of human immune     globulin and to see how well it works in treating patients with primary amyloidosis that is     causing heart dysfunction.   "
206227|NCT00547378|"     The purposes of this study are:        1. To provide evidence from a randomized controlled trial that InterStim Therapy provides          better relief of symptoms of OAB than standard medical treatments in current use.        2. To fulfill the requirements of the FDA-mandated post-approval study of the safety of the          tined lead using a minimally invasive approach.   "
206228|NCT00547391|"     The purpose of this study is to find out if tonsillectomy reduces the short-term risk of     having an objectively confirmed (sequential changes in serum crp and procalcitonin levels)     delayed pharyngitis episode among patients suffering from recurrent pharyngitis episodes.     Other aims are to find out the effect of tonsillectomy to reduce the number of pharyngitis     episodes or symptoms. Still, the possible disadvantages of tonsillectomy and changes in the     quality of life after tonsillectomy among these patients are examined.   "
206229|NCT00547404|"     This research study is a Phase I/II clinical trial. It is done to determine the best doses     that the investigational drug (P276-00) can be used safely. Investigational means that the     drug is still being studied and that research doctors are trying to find out more information     about it such as; the safest dose to use, the side effects it may cause and if it is     effective for treating relapsed/refractory multiple myeloma.      A majority of multiple myeloma patients overexpress a protein that plays a role in regulating     the body's cell cycle called Cyclin D1. The study drug P276-00 is a Cyclin D1 inhibitor under     investigation in the treatment of solid tumors. The researchers therefore believe that Cyclin     D1 should be studied as a therapeutic target in myeloma. In this research study, we are     looking for the highest dose of P276-00 that can be given safely and to see how well it works   "
206230|NCT00547417|"     To compare men of different races and those with diabetes or depression to white men that do     not have diabetes or depression but also suffer from the inability to get or keep an     erection.   "
206231|NCT00547443|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving sorafenib together with high-dose chemotherapy     and external-beam radiation therapy may kill more tumor cells.      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of     sorafenib when given together with high-dose carboplatin, paclitaxel, and external-beam     radiation therapy in treating patients with stage III non-small cell lung cancer.   "
206232|NCT00547456|"     We will determine whether oxygen therapy lowers the level of substances in the blood which     cause inflammation, which is one of the adverse effects of COPD and whether oxygen improves     overall well being and quality of life as well as sleep quality.   "
206233|NCT00547469|"     This study will evaluate the safety and effectiveness of the investigational drug DDP733 in     treating female patients with IBS-c. A placebo control will be utilized.   "
206234|NCT00547482|"     The main purpose of this research study is to investigate whether the TANTALUS II System is     effective in improving glycemic (blood sugar) control in subjects who have type 2 diabetes     (high blood sugar) and are overweight. The research will also evaluate the impact on weight     loss and will study other health conditions related to obesity.      This research study involves an experimental system. The experimental system is the TANTALUS     System, which consists of the implantable portion that includes the implantable pulse     generator (IPG) and three pairs of implantable leads. There are also three external parts     (items that are used outside your body): the programmer, the charger, and the Patient Wand.   "
206235|NCT00547495|"     Study to determine how safe and effective tadalafil is for Japanese men taking it when they     need to get and keep an erection.   "
206236|NCT00547508|"     Study to see how effective different doses of tadalafil are for getting and keeping an     erection when sex is attempted after a certain number of hours.   "
206237|NCT00547521|"     To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in     the absence of an IV loading dose of abatacept   "
206238|NCT00547534|"     The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded     to, or that has returned after standard treatment, responds to bortezomib, rituximab and     bendamustine, and also to see what effects this drug combination have on this cancer.   "
206239|NCT00547547|"     RATIONALE: Brassica juncea that contains high amounts of selenium may slow the growth of     cancer cells. Drugs used in chemotherapy, such as irinotecan and capecitabine, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving high-selenium Brassica juncea together with combination     chemotherapy may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of high-selenium     Brassica juncea and capecitabine when given together with irinotecan in treating patients     with advanced cancer.   "
206240|NCT00547560|"     To assess the safety and tolerability of ascending, multiple, oral doses of GSI-953 in     healthy elderly subjects.   "
206241|NCT00547573|"     Study to determine if tadalafil works better than placebo for Asian men having trouble     getting or keeping an erection.   "
206242|NCT00547586|"     The primary purpose of this study is to evaluate the safety and dose-response relationship of     N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects     with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel     dysfunction (OIBD).   "
206243|NCT00547599|"     To determine if patients who are distressed over having problems getting or maintaining an     erection react differently to the medication than those who are not stressed over the issue.   "
209180|NCT00588627|"     This study is being done to find out why some people with mucus dripping down the back of     their throat have a nagging cough while others do not cough.   "
206244|NCT00547612|"     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using     [18F]-labeled substance P antagonist receptor quantifier, may be effective in finding disease     in patients with pancreatic cancer.      PURPOSE: This phase I trial is studying how well a PET scan using [18F]-labeled substance P     antagonist receptor quantifier works in finding disease in patients with pancreatic cancer.   "
206245|NCT00547625|"     Study to look at safety and effectiveness of different doses of tadalafil on prostate related     genital/urinary tract problems.   "
206246|NCT00547638|"     This is a multicenter, prospective, randomized controlled study for the purpose of comparing     DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. The     objective of this study is to demonstrate whether the incidence of wound closure for     DERMABOND PROTAPE is equivalent to that measured for DERMABOND HVD.   "
206247|NCT00547651|"     This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from     growing. The purpose of this study is to evaluate the effect of amrubicin compared to     topotecan in the treatment of small cell lung cancer.   "
206248|NCT00547664|"     The overall aim of this study is to find out whether Hylenex recombinant (for short, Hylenex)     in subcutaneous (SC) injection improves the speed and effectiveness of SC opioids in hospice     patients. Specifically, this study proposes to compare the level of self-reported pain in     hospice patients started on SC infusions of morphine and hydromorphone (Dilaudid) over the     initial 8 hours of opioid infusion with and without the preceded co-injection of Hylenex.     Hospice patients include both home-bound patients as well as those under intensive care in     hospice houses.   "
206249|NCT00547677|"     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and     cause less damage to normal tissue.      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic     radiosurgery in treating patients with liver metastases.   "
206250|NCT00547690|"     The primary purpose of the study is to examine the effect of acupuncture treatment when     combined with strength training on the motor functional recovery of stroke survivors   "
206251|NCT00547703|"     The purpose of this study is to determine if use of Nortriptyline will improve symptoms and     quality of life in patients who have nonulcer dyspepsia.   "
206252|NCT00547716|"     Hepatitis C virus infection is the most common blood-borne infection in the United States and     is a leading cause of chronic liver disease affecting 130 million people around the world. It     is estimated that 1.6% of the US population may be affected by Hepatitis C infection. The     only recommended treatment that has been approved for your condition is the use of interferon     and ribavirin. In patients with chronic Hepatitis C, there tends to be an accumulation of fat     in the liver. Fatty liver has been associated with failure of treatment.      The accumulation of fat in the liver has been blamed on a particular type of fat called     triglycerides. Fish oil, by reducing a type of fat called VLDL, can lower the triglyceride     concentration by as much as 50 percent or more. This study seeks to determine if the     administration of fish oil along with standard treatment to patients with Hepatitis C will     increase the treatment response rates.   "
206253|NCT00547729|"     Most people with heart failure take a number of medications that work in different ways.     Patients and their families need to keep track of prescribed medications and follow     instructions on how much to take and when to take them. Currently, doctors are guided     primarily by symptoms. The device being studied in this trial (called the HeartPOD™ System)     monitors heart function from inside your body and alerts the patient and physician of     necessary changes to your medication.   "
206254|NCT00547742|"     To correlate serum proteomics patterns with PET/CT findings to improve cancer diagnosis,     staging, prognosis, and therapy monitoring.   "
206255|NCT00547768|"     Compare the effect of a single dose of fexofenadine HCl 180 mg plus orange juice versus     placebo plus orange juice on the change from baseline (pre-dose) in histamine skin flares.   "
206256|NCT00547781|"     The aim of this study is to performed a randomized controlled trial to evaluate the     usefulness of preimplantation genetic diagnosis (PGD) in patients with repetitive     implantation failure. Patients will be prospectively randomized in two groups: standard IVF     with blastocyst transfer on day-5 and transfer day-5 after PGD for aneuploidy screening for     chromosomes 13, 15, 16, 18, 21, 22, X and Y. The end points of the study are: Cancellation     rate; implantation rate and ongoing implantation rate. Inclusion criteria are: patients with     ≥2 previous IVF failure without clinical or biochemical pregnancy with transfer of at least 2     good quality embryos per transfer. Exclusion criteria will be uterine abnormalities ,     abnormal karyotypes, abnormal result in thrombophilia screening and low responder patients     (less than 4 expected oocytes).   "
206257|NCT00547794|"     The purpose of the study is to determine if the combination of AVJ ablation followed by BiV     pacing significantly improves functional status and exercise capacity compared to     pharmacologic rate control in patients with chronic AF and depressed ejection fraction,     regardless of rate or QRS duration.   "
206258|NCT00547807|"     Non pharmacological approaches are important in pain control in neonates, specially in term     healthy neonates. Non-nutritive sucking and swaddling are considered effective strategies for     pain control in these population, but the effect in their association are not clear until     now. The hypothesis of the study is that association between non-nutritive sucking and     swaddling reduces pain scores resulting from venepuncture compared to non-nutritive sucking     alone.   "
206259|NCT00547820|"     Evaluation of urinary sensor that will be activated by the urine during voiding     cystourethrography in pediatric patients   "
206269|NCT00547950|"     In order to observe the influence of the Dengzhan Shengmai Capsule on the endpoint of     patients with ischemic stroke, we hold the multi-centered prospective cohort study. From     November 2007 to December 2009, 12000 subjects are included in 200 clinical research centers     all over China. The subjects naturally formed two cohorts based on taking Dengzhan Shengmai     capsule or not. The basic therapy included antiplatelet aggregation , stroke health     education, management of blood pressure, blood lipid and blood glucose, etc. Then all of the     subjects are visited on the 360th day after inclusion. The recurrence of stroke,     cardiovascular events, and peripheral arterial events are observed.   "
206490|NCT00550121|"     In CHF central sympathetic activity is increased. ROS formation seems to play a role in this     process. This study analyzes the effect of vitamin C as an antioxidant on central sympathetic     activity in CHF   "
206260|NCT00547833|"     Children with language-learning disabilities (LLD) have language and reading skills that are     weaker than those of typically developing children. In the school-age years, reading is a     primary means of exposure to new vocabulary for typically developing children. Although these     children would not be expected to master a new word through a single exposure to it in text,     children show evidence of partial word knowledge growth (e.g., Wagovich & Newhoff, 2004). The     purpose of this project is to characterize the partial word knowledge growth of children with     LLD, in comparison to children with typical language skills. Five forms of partial word     knowledge (e.g., orthographic, word discrimination, syntactic, emotional content, and general     semantic domain knowledge) are being measured. The study's hypotheses are that children with     LLD, like typically developing peers, will demonstrate partial word knowledge growth from     exposure to unfamiliar words in text, but that they will show a different pattern of growth     across the five forms of partial word knowledge being assessed.   "
206261|NCT00547846|"     The pharmacological effects of PDC-748 were tested in numerous in vitro and in vivo studies.     The existing pharmacologic findings suggest that PDC-748 possesses certain inhibitory     activity to the citric acid- and capsaicin-induced cough reflex in guinea pigs with a     dose-dependent manner. Furthermore, a previous Phase I/II uncontrolled, dose-escalating study     has shown PDC-748 to be well tolerated and may help to alleviate daytime cough with a     dose-responding manner.Hence, PhytoHealth Corporation intends to carry out a Phase II     investigation to confirm the preliminary findings using placebo in the comparator group, and     to further investigate PDC-748 with a dose escalating manner to establish the dose-response     range for its antitussive effect, and if possible, to determine the maximal tolerable dose of     PDC-748.      This is a randomized, double-blind, placebo-controlled, dose escalating study to evaluate the     safety and efficacy of the escalating dose levels of PDC-748 in patients with acute cough.   "
206262|NCT00547859|"     The purpose of this study is to correlate microcirculatory flow and rectal anaerobe cellular     CO2 production in patients after cardiac surgery. The hypothesis is that such a correlation     exists.   "
206263|NCT00547872|"     In the present study a cohort of diabetic patients without any symptoms and without known     coronary artery disease (CAD) will be screened at the investigators' diabetes outpatients     services. Those with intermediate or high risk will be asked to participate and enrolled.     They will be seen and followed by the cardiologists in order to provide the best adherence to     medical therapy. By mean of a randomization process, a group of patients will undergo an     exercise electrocardiography (ECG) testing while the other group will continue to be     regularly seen at the investigators' cardiology service. Those patients with a positive     exercise ECG test will be study by coronary angiography and treated according to the severity     of coronary lesions by percutaneous stenting or surgery. Both groups of patients will be seen     every six-eight months for the next three years.   "
206264|NCT00547885|"     We wish to compare the effect of long acting vs short acting opioids in chronic non-malignant     pain. The study opioid is Dihydrocodeine Continus and Dihydrocodeine 30 mg tablets. We     measure pain relief, health related quality of life, sleep, breakthrough pain and depression     with validated questionnaires to compare the two treatment arms.      Hypothesis: The pain relief will be better and more stable with long acting opioids. Quality     of sleep, breakthrough pain and quality of life will also be improved with long acting     dihydrocodeine.   "
206265|NCT00547898|"     This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study.     This study will compare an investigational new drug (crofelemer) to placebo for the control     of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of     study drug based on safety and response to therapy and the second stage will evaluate further     the effectiveness of the optimal dose.   "
206266|NCT00547911|"     An experimental drug called L-DOPS increases production in the body of a messenger chemical     called norepinephrine. Cells in the brain that make norepinephrine are often gone in     Parkinson disease. The exact consequences of this loss are unknown, but they may be related     to symptoms such as fatigue, depression, or decreased attention that occur commonly in     Parkinson disease. This study will explore effects of L-DOPS in conjunction with carbidopa     and entacapone, which are drugs used to treat Parkinson disease. We wish to find out what the     effects are of increasing norepinephrine production in the brain and whether carbidopa and     entacapone augment those effects.      Volunteers for this study must be at least 18 years of age and able to give consent to     participate in the study. To participate in the study, volunteers must discontinue use of     alcohol, tobacco, and certain herbal medicines or dietary supplements, and must also taper or     discontinue certain kinds of medications that might interfere with the results of the study.     Candidates will be screened with a medical history and physical exam.      Participants will be admitted to the National Institutes of Health Clinical Center for two     weeks of testing. The study will have three testing phases in a randomly chosen order for     each participant:        -  Single dose of L-DOPS        -  Single dose of L-DOPS in conjunction with carbidopa        -  Single dose of L-DOPS in conjunction with entacapone      Each phase will last two days, with a washout day between each phase in which no drugs will     be given and no testing will be performed. In each phase, participants will undergo a series     of tests and measurements, including blood pressure and electrocardiogram tests. Participants     who are healthy volunteers will also have blood drawn and will undergo a lumbar puncture     (also known as a spinal tap) to obtain spinal fluid for chemical tests.   "
206267|NCT00547924|"     Severe hypotension during reperfusion in liver transplantation is a frequent adverse event.     Rare data exist so far about pathophysiology of this phenomenon. The exact role of left     ventricular function, which might be impaired causing hypotension, has not been elucidated     during the period of reperfusion.      Goal of this study is to:        -  perform transesophageal echocardiography in order to assess systolic and diastolic left          ventricular function during reperfusion        -  determine inflammatory mediators in the plasma which could cause left ventricular          dysfunction   "
206268|NCT00547937|"     Background: Previous studies present contradictory data concerning obstructive sleep apnea     syndrome (OSAS), lipid oxidation and nitric oxide (NO) bioavailability. This study was aimed:     (1) to compare the concentration of 8-isoprostane and total nitrate and nitrite (NOx) in     plasma of middle aged males with OSAS and no other known comorbidity and carefully matched     healthy controls of the same age and gender; and (2) to test the hypothesis that nasal     continuous positive airway pressure (CPAP) therapy, might attenuate oxidative stress and     nitrate deficiency.   "
206270|NCT00547963|"     The purpose of this study is to determine the effectiveness of two brief counseling sessions     delivered to emergency department (ED) patients who report conjoint alcohol and marijuana     use, in reducing injuries and other negative consequences, in comparison to an assessment     only group.   "
206271|NCT00547976|"     Inflammation in the vascular wall is important in atherosclerosis and the blockage of the     artery. The peripheral benzodiazepine receptor is involved in inflammation and in this     protocol we will attempt to take pictures, using PET camera, of inflammation in patients with     atherosclerosis and compare those of healthy people.   "
206274|NCT00548015|"     Hand hygiene prescriptions are the most important measure in the prevention of hospital     acquired infections. Yet compliance rates are generally below 50% of all opportunities for     hand hygiene adherence. This study will test the short- and long term effects of two     strategies for promoting hand hygiene in hospital nurses   "
206275|NCT00548041|"     The purpose of the study is to evaluate the feasibility of a rapid HIV testing program in the     Temple University Hospital(TUH)Emergency Department. We hypothesize that a rapid HIV testing     program in the TUH Emergency Department is feasible. Patients presenting to the Adult TUH     Emergency Department with certain conditions will be offered rapid HIV testing. Testing will     be performed by oral swab using the OraQuick Advance test. Patients will receive post-test     counseling.   "
206276|NCT00548054|"     In order to assess whether the bivalent killed oral cholera vaccine may be used safely among     infants who are most at risk for cholera, the investigators need to determine the safety and     immunogenicity of the killed oral cholera vaccine among infants less than 1 year of age when     given with the expanded program on immunization (EPI) vaccines including diptheria, pertussis     and tetanus (DPT), oral polio vaccine (OPV), Hepatitis B vaccines and measles vaccine.     Furthermore, the investigators also need to make sure that immune interference does not occur     among all the other vaccine antigens given at the same time. Findings from this study will     pave the way for the possible use of the killed whole cell oral cholera vaccine (OCV).   "
206277|NCT00548067|"     The purpose of this study is to determine potential pharmacokinetic drug-drug interaction     when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.   "
206278|NCT00548080|"     Registration study   "
206279|NCT00548093|"     To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804     taken daily, as single agent in patients with advanced NSCLC who failed at least one     chemotherapy + erlotinib.   "
206280|NCT00548106|"     The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment     age 0-14 days) will be assigned randomly to receive one of two products, provided in     identical packages except for the lid color. Neither the investigators nor the parents will     know which product the infant is receiving.      The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.      There will be two study groups, each receiving one of the following formulas:        1. The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula          containing partially hydrolyzed whey protein, produced and packaged by Materna          Laboratories, Maabarot.        2. The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by          Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging          identical to the Materna product, except for the lid color   "
206281|NCT00548119|"     The objective of this study is to gather additional information regarding the performance of     NeoCart to fill articular cartilage defects in the knee.   "
206282|NCT00548132|"     We proposed to perform a prospective randomized controlled trial to study the effect of the     use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of     central venous catheter care on catheter-related bloodstream infections among patients in two     Barnes-Jewish Hospital ICUs.   "
206283|NCT00548145|"     Some studies suggest that statin medications may be effective against Alzheimer's disease.     However, this has not been proven. The purpose of this study is to evaluate the efficacy of     pitavastatin in patients with mild to moderate Alzheimer's disease and hypercholesterolemia.   "
206284|NCT00548158|"     We are studying patients with diabetes who under proper medical care and administer an     approved drug. Our interest is if this drug has any sideeffect on vision and if this drug may     cause swelling of the retina.   "
206285|NCT00548171|"     The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in     adults 10 years after previous booster vaccination with dTpa in a previous clinical study.     Only subjects who received the booster vaccination in a previous clinical study are eligible     for participation in this study. The Protocol Posting has been updated in order to comply     with the FDA Amendment Act, Sep 2007.      No new recruitment will be performed in this booster phase (see inclusion criteria)   "
206286|NCT00548184|"     We think that lapatinib will help to shrink your tumor when given prior to the main or     primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is     given before the main or primary therapy, it is called neoadjuvant therapy. We will compare     lapatinib with lapatinib plus trastuzumab (herceptin) for 12 weeks. If your tumor is estrogen     receptor positive (ER positive), estrogen deprivation will also be given to you. Tumors that     are ER positive have a lot of estrogen receptors found in them. This is also called over     expression or amplification of estrogen receptors.      The most important information we will get from this study is to see the response to     neoadjuvant (treatment given before the main treatment), lapatinib with trastuzumab     (herceptin) in your tumor tissue sample.   "
206287|NCT00548197|"     Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated     with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from     fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and     techniques are used.      Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular     neovascularization. Its intraocular injection has been increasingly used for treatment of     choroidal neovascularization (CNV) associated with age related macular degeneration (AMD)     with fairly good success.Also it has been shown to be effective for treatment of PDR     complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if     anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before     vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting     in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and     shorter and lessen the need for intraocular cautery..      In this study diabetic patients who are candidated for vitrectomy with similar complexity     scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In     the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial,     Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before     operation.      During each operation, the number of endodiathermy applications, backflush needle     applications and the duration of surgery will be recorded by an independent observer. Also,     type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual     acuities wil be recorded. all these parameters will be compared in two groups.   "
206289|NCT00548223|"     In order to observe the secondary preventive effect of the Dengzhanshengmai capsule on     ischemic stroke, the investigators hold the large randomized control trial (RCT). 3143     subjects are included in 83 clinical research centers all over China. The subjects are     randomly grouped into two groups. The basic therapy included antiplatelet aggregation, stroke     health education, management of blood pressure, blood lipid and blood glucose, etc. The     treating group will take the compound Chinese Medicine Deng Zhan Sheng Mai capsule and the     contrast group will take the placebo for twelve months. Then all of the subjects are visited     on the 30th, 90th, 180th, 360th day after inclusion. The recurrence of stroke, cardiovascular     events, and peripheral arterial events are observed.   "
206290|NCT00548236|"     This study is being done to determine whether a telephone-based counseling intervention can     help survivors of breast and colorectal cancer increase their weekly physical activity.     Observational evidence suggests that physical activity after breast and colorectal cancer     diagnosis decreases recurrence rates. Unfortunately, many people become less active during     cancer therapy, and a substantial proportion never return to pre-diagnosis levels of physical     activity. This study looks to see if people who have recently finished chemotherapy for     breast, colon or rectal cancer can be motivated to increase their exercise by talking to an     exercise specialist over the phone. The study also looks at changes in mood, fatigue,     fitness, fat distribution and weight.   "
206291|NCT00548249|"     The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble     Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during     chronic hemodialysis.   "
206292|NCT00548262|"     The primary objective is to estimate global response rate. Clinical, microbiological and     global response rates and its 95% confidence intervals will be computed. No hypotheses will     be tested.   "
206293|NCT00548275|"     The major goal is to determine in patients entering buprenorphine treatment, the prevalence     of specific sex-related HIV risk behaviors, their physician's screening of these behaviors     and to evaluate the impact of risk reduction counseling.   "
206294|NCT00548288|"     The aims of the study are to determine whether pamidronate applied locally causes diminished     periprosthetic bone loss and decreased rate of bone turnover compared to patients receiving     placebo after cemented total hip arthroplasty (THA). The study design will be prospective,     randomized, and blind. Periprosthetic bone mineral density (BMD) will be measured with dual     energy X-ray absorptiometry (DXA) at the total periprosthetic area as well as at seven Gruen     zones or regions of interest. DXA scans will be performed at one week (baseline), three     months, and six months postoperatively. Mean values of biochemical markers of bone turnover,     BMD, and baseline-normalized BMD values will be compared between the bisphosphonate and     placebo groups at each time point. For all temporal measurements including bone markers, BMD     and normalized BMD, mean values will be compared across each time point within a given group.   "
206295|NCT00548301|"     The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in     the treatment of dry eye syndrome.   "
206296|NCT00548314|"     The purpose of this study is to determine whether a treatment of full thickness wounds by the     dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality,     demonstrated by a significant increase of skin elasticity parameters after 3 months.      Additionally, an increase of the take of graft and improvement of scar assessment scale, scar     colour/pigmentation and time to complete wound closure, is expected.   "
206297|NCT00548327|"     This study will evaluate whether Atomoxetine improves cognition in healthy volunteers as well     as patients with schizophrenia. Atomoxetine is a drug that has been Food and Drug     Administration (FDA) approved for Attention Deficit Disorder and allegedly increase the     amount of the neurotransmitter dopamine in the frontal cortex of the brain.   "
206298|NCT00548340|"     The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind     treatment period of VEC-162 as compared to placebo in male and female patients with primary     insomnia.   "
206299|NCT00548353|"     A study to assess safety and PK of an investigational drug in migraine patients during and     between migraine attacks.   "
206300|NCT00548366|"     To determine the relationship between degree of sodium restriction and dietary compliance     with clinical outcome of diuresis of portal hypertensive ascites in cirrhotic patients from a     county hospital population.      Primary objective: Demonstrate that, when accompanied by the appropriate diuretic regimen, a     No Added Salt diet (4 grams sodium per day) is as effective as a Low Sodium diet (2 grams     sodium per day) in the management of cirrhotic ascites.   "
206301|NCT00548379|"     Background: Pneumonia is the leading cause of childhood mortality, accounting for 19% of the     10.6 million deaths that occur each year1. Case-control studies from Ethiopia2 and India3     suggest that sub-clinical vitamin D deficiency may increase ten times the risk of pneumonia     in children. We postulate that controlling childhood vitamin D deficiency has the potential     to dramatically reduce the incidence of pneumonia and save >700,000 lives each year since     vitamin D deficiency is widespread in developing countries.      Aim: To investigate whether 3-monthly oral supplementation of 100,000iu vitamin D reduces     pneumonia and its consequences among children aged 1-12 months (followed for 18 months),     living in a deprived area of Kabul, Afghanistan, where >70% of young children are vitamin D     deficient (<8ng/dl). The effect of vitamin D on the incidence of other diseases, in     particular diarrhea and rickets will also be investigated.      Methods: Randomised double-blind placebo-controlled trial: 3000 children will be randomised     to receive either 6 doses of vitamin D or placebo. The first dose will be given at the start     of autumn and the second and subsequent doses every 3 months thereafter; children will be     followed for 18 months. Incidence of pneumonia will be ascertained though weekly home visits     (active surveillance) and from attendances and admissions at the trial clinic and wards in     the hospital serving the study area (passive surveillance).   "
206302|NCT00548392|"     The purpose of this study is to determine how long collagen based marker clips remain visible     by ultrasound after placement in suspicious breast lesions and if collagen based marker clips     can be reliably identified in the operating room and serve as effective guidance for surgical     removal of high risk or malignant breast lesions.   "
206508|NCT00550368|"     The study proposes to test whether chronic infection with Helicobacter pylori protects     individuals from symptomatic infection with enteropathogenic E. coli. The study will also     evaluate the effect of gastric acidity in this relationship.   "
206303|NCT00548405|"     The purpose of this study was to establish the efficacy and safety of two different doses of     alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in     comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who     had received an adequate trial of disease-modifying therapies but experienced at least 1     relapse during prior treatment, and who met a minimum severity of disease as measured by     magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive     testing every 3 months.   "
206304|NCT00548418|"     The purpose of this study is to determine whether the combination of topotecan, cisplatin and     bevacizumab is effective in the treatment of recurrent or persistent cervical cancer   "
206305|NCT00548431|"     The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and     antileukemic response during the initial 3 months of individualised therapy of children and     young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual     toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used     in the two-months post-remission treatment phase of lower risk childhood ALL. This will be     performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m^2)     every 3rd week. Thus, the trial will also test the feasibility of this particular drug     combination.   "
206306|NCT00548444|"     This study examines the early immune response to a new vaccine (MVA85A) being developed to     combat tuberculosis (TB).   "
206307|NCT00548457|"     The aim of this study is to show the frequency of endothelial dysfunction in patients     suffering from ectatic coronary arteries as compared to those who have normal coronary     arteries. Should this frequency be significant we would recommend initiating conventional     treatment in those patients with ectatic coronary arteries as is the practice in patients     with endothelial dysfunction without ectatic arteries   "
206308|NCT00548470|"     This is an open label pre-post study of the effects of clinical treatment with varenicline on     1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in     schizophrenic patients, and 3) effects nicotinic binding to leukocytes and DNMT1 mRNA in     lymphocytes. Patients are assessed on subjective and objective measures of smoking , selected     cognitive measures, and special chemical measures, during baseline testing and during 8 weeks     of treatment with varenicline ( 1-3 mg/day).   "
206309|NCT00548483|"     The specific objectives were to determine whether high dose dexamethasone are more effective     than low dose dexamethasone in the reduction or prevention of post-extubation airway     obstruction among patients with a cuff leak volume (CLV) < 110 mL.   "
206310|NCT00548496|"     This is a study designed to test the safety and effectiveness of SB-751689 in the treatment     of a distal radius fracture in post-menopausal women and men in comparison to placebo to     determine if healing time of the fracture can be decreased.   "
206311|NCT00548509|"     To investigate the effect of menatetrenone on bone turnover in postmenopausal patients with     osteoporosis. One month of menatetrenone therapy enhanced the secretion and     gamma-carboxylation of osteocalcin. Moderate increases of bone resorption and formation     markers were observed after 6 months. These changes may contribute to fracture prevention in     patients with osteoporosis.   "
206312|NCT00548522|"     Type 1 diabetic women have a decrease in insulin requirements during early pregnancy.     Preliminary evidence suggests this decrease may be secondary to the regeneration of     pancreatic B-cells during pregnancy During the second and third trimesters, insulin     requirements in Type 1 diabetic women progressively increase until approximately 36 weeks     gestation at which time there is a plateau, and frequently, a drop in insulin requirements.     We hypothesize that there is regeneration of pancreatic islet cell mass in Type 1 diabetic     women during pregnancy. In a cross-sectional study, we will use the acute insulin c-peptide     response to arginine to determine if pancreatic islet mass increases at 12 and 36 weeks     gestation. Type 1 diabetic women who are not pregnant, who are at 12 and 36 weeks gestation,     and who are 6 weeks post-partum will undergo an intravenous arginine tolerance test following     an overnight fast. If we find that there is regeneration of beta cells it opens the     possibility that therapy may be directed to the same end for people with Type 1 diabetes.   "
206313|NCT00548535|"     Aim of the study is to evaluate the reliability of self-reported surgical outcome by     residents        -  prospective assessment of postoperative complications done by residents using a          validated five-scale complication classification        -  simultanously, complications will be prospectively assessed in the same manner by an          external clinical nurse        -  Trial with surgical intervention   "
206314|NCT00548548|"     This study will compare treatment with bevacizumab in combination with capecitabine and     cisplatin versus placebo in combination with capecitabine and cisplatin, as first-line     therapy in patients with locally advanced or metastatic gastric cancer who had not received     prior chemotherapy for advanced or metastatic disease.   "
206315|NCT00548561|"     The purpose of this study is to avoid surgical intervention following extravasation of     anthracycline chemotherapy out of a vessel into the surrounding tissues.   "
206316|NCT00548574|"     The primary objective of the study was to compare the percentage of subjects in remission     after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day     once daily versus placebo   "
206317|NCT00548587|"     This is a multi-center, randomized, double-blind, placebo-controlled study to determine the     safety and tolerability of E5555 in subjects with Acute coronary syndrome (ACS).   "
206318|NCT00548600|"     The specific objective of this study is to compare the relative efficacy of the combination     of a temporary iridium implant plus external beam irradiation versus standard external beam     irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be     assessed in terms of local recurrence, survival, and toxicity.   "
206330|NCT00542373|"     The goal of this clinical research study is to evaluate fluorescence imaging, widefield     fluorescence imaging, point spectroscopy imaging methods, and or/ oral brush cytology that     may help doctors monitor patients at an increased risk of developing an oral cancer,     including those with pre-cancerous lesions in the mouth.   "
206331|NCT00542386|"     This is a phase III multi-centre study in two periods: the first period is a phosphate binder     and lipid lowering drugs washout for 8 weeks, the second period is a double-blind,     randomised, parallel group, fixed dose, for 12 weeks.   "
206319|NCT00548613|"     The purpose of this research study is to determine if the transplant of a combination of stem     cells, obtained from the bone marrow of the same patient, is effective for utilization and     rescue of infarcted myocardium. End points will be the assessment of development of mature     and stable new blood vessels as well as improvement in cardiac function.      This, Phase I, single center, prospective, non-randomized, open-label study will evaluate the     safety and feasibility of use of the proposed combination of autologous stem cells. Potential     subjects who fulfill clinical and laboratory entry criteria at screening will undergo a     process of bone marrow aspiration for preparation of the two types of bone marrow-derived     stem /progenitor cells to use. The two bone marrow-derived cell types will be mixed and     implanted to patients approximately 2 weeks after bone marrow aspiration. After transplant,     patients will be have a 3 month follow-up to evaluate safety as well as functional heart     improvement by analysis of symptoms, myocardial perfusion SPECT, and echocardiography.      Study population will include adult male and female subjects, ages 18-70, presenting with     acute myocardial infarction and subjects who have had a recent (within 12 months) myocardial     infarction and will undergo coronary artery bypass grafting.      Patients will be divided in two groups:        -  the first group will enroll patients with acute myocardial infarction whom percutaneous          coronary intervention restored myocardial flow after 4 hours or greater of the          initiation of symptoms,        -  the second group will enroll patients who are candidates for coronary artery bypass          surgery and had a myocardial infarction in the past 12 months.      Patients will receive the cell mixture by intracoronary or intramyocardial infusion,     respectively.      The rationale of this clinical study is based on the observation that most attempts using     adult stem cells for myocardial regeneration have utilized a source of bone marrow derived     progenitor cells with the potential to generate new blood vessel and thus contribute to the     revascularization of the ischemic tissue. This therapy seems to be adequate but not     sufficient, since it lacks a source of stem cells capable of differentiating and maturing     into cardiac muscle cells, thus contributing to the recovery of local contractility. The     proposed combination stem/progenitor cell therapy to be used in this protocol is aimed at     contributing cell types capable of regenerating both blood vessels and muscle tissues damaged     after MI.   "
206320|NCT00548626|"     The aim of this study is to evaluate if the early change of needle during EUS-FNA for     suspected pancreatic cancer allows an earlier preliminary cytological diagnosis of neoplasia.   "
206321|NCT00542256|"     The purpose of this study is to determine whether a painless and noninvasive procedure called     transcranial direct current stimulation (tDCS) combined with a method of physical therapy     called constraint-induced movement therapy improves motor function in patients with chronic     stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning     tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS     procedure sessions will be compared to sham (fake) procedure sessions, which is also called     placebo stimulation. This study is double blind, which means neither the subjects nor     researchers analyzing motor function will know if participants are receiving real tDCS     stimulation or placebo. Only the person performing the procedure will know which one     participants are receiving. Only by comparing the tDCS procedure to a sham (placebo)     procedure can we understand if the tDCS actually improves motor function.      We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on     motor recovery in chronic stroke patients.   "
206322|NCT00542269|"     This proof of concept study is designed to evaluate the efficacy and safety of the     combination therapy of aliskiren and ramipril as add-on to amlodipine in the treatment of     patients with essential hypertension and metabolic syndrome who do not respond adequately to     amlodipine monotherapy.   "
206323|NCT00542282|"     Obstructive lung disease is usually a differential diagnostic consideration when a patient     presents with breathlessness or cough. Spirometry is the key diagnostic test used to confirm     airflow obstruction particularly in the primary care setting. Airflow obstruction that     completely resolves after administration of a bronchodilator, by definition, excludes a     diagnosis of COPD. Evaluation of obstructive lung disease must include pulmonary function     testing; bronchoreversibility testing is an adjunct in differentiating between asthma and     COPD. Bronchoreversibility cannot serve as an absolute diagnostic criterion for separating     asthma from COPD.      Vibration response imaging (VRI) technology provides a simple, radiation-free method to image     the lungs, by visualizing vibration energy (lung sounds) emitted during respiration cycle. In     this study, regional quantitative and qualitative information on vibration response is     compared with spirometry in assessing lungs function of COPD and Asthma patients.   "
206324|NCT00542295|"     To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to     the latest recommended design   "
206325|NCT00542308|"     Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.   "
206326|NCT00542321|"     Intensive care unit (ICU) patients on respirators are at high risk for preventable pulmonary     complications (PPC). Turning these patients from side to side may reduce PPC, but carries the     burden of decreases in blood pressure and oxygenation. The investigators hypothesize that     there will be no difference in PPC or adverse events when ICU patients on respirators are     turned by nurses or by an automated turning bed.   "
206327|NCT00542334|"     This study will help determine the frequency and magnitude of nocturnal hypoglycemia (low     blood sugar at night during sleep), in children with type 1 diabetes who are on a standard     insulin regimen, by using a Continuous Glucose Monitoring System (CGMS). Secondary objectives     include the establishment of a definition of nocturnal hypoglycemia for the CGMS and for the     calculation of sample size needed for future studies using CGMS. Nocturnal hypoglycemia (NH)     can be associated with significant morbidity including seizure and coma. The investigators     intend to use the CGMS in a future study investigating the use of a new insulin combination     aimed to decrease the frequency of NH in the pediatric population.      Thirty pediatric subjects with established type 1 diabetes mellitus will be asked to wear a     CGMS for 3 days. During this time the participants will be required to test and record     self-monitored blood glucose readings at designated time periods and if they have symptoms of     hypoglycemia. The comparison of these values with each other and with different previously     defined values of NH will allow for a clear definition of NH to be made. A survey has also     been designed to assess participant satisfaction with the CGMS.   "
206328|NCT00542347|"     Proton pump inhibitors (PPI) are used to decrease stomach acid secretion. A generic form of     omeprazole, one of the PPIs, is on the market. With cheaper than brand name PPIs, it is     unclear whether generic omeprazole is as effective clinically. This study compares generic     omeprazole with half-dose esomeprazole, the strongest brand name PPI. The half-dose     esomeprazole is in fact cheaper than generic omeprazole. Healthy volunteers will take each     medication in turn for 7 days and their stomach acid will be measured while taking each     medication. We hypothesize that half-dose esomeprazole is better at suppressing stomach acid     than generic omeprazole.   "
206329|NCT00542360|"     This cluster randomized trial will test whether a social marketing program implemented in     churches can motivate older adults to join exercise classes, in order to improve their     strength and balance and thus prevent falls.   "
206509|NCT00550381|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of     single doses of HKI-357 administered to healthy subjects.   "
206332|NCT00542399|"     An open-label, treat to target, intervention study in order to compare the metabolic control     of once to twice-daily insulin Detemir injections in children and adolescence with type 1     diabetes mellitus.      All eligible patients will be assigned to receive insulin Detemir once daily before     breakfast. Short acting insulin analog, Novorapid, will be used for mealtime insulin. The     starting dose of insulin Detemir will be individually determined.Based on self-measured     fasting blood glucose levels, insulin doses will be titrated throughout the trial, aiming at     pre-breakfast and premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and     80-130 mg/dl for subjects aged 13-18 years.Patients that after 4 weeks titration phase will     not achieve the target blood glucose and up titration of insulin Detemir cannot be done, due     to hypoglycemic episodes would be switched to treatment consist of twice daily insulin     Detemir. If the target blood glucose are not achieved at the end of the 4 weeks titration     phase, but further up titration is possible and patient does not suffer from hypoglycemic     episodes, the titration period would be extended and patient would not be switched to     treatment with 2 injections of insulin Detemir.When achieving blood glucose targets patient     will continue until study end on the maintenance phase.   "
206333|NCT00542412|"     Evaluate the efficacy of riluzole 50-mg bid defined by comparing the percentage of     riluzole-treated subjects who experienced death, permanently assisted ventilation (PAV) or     tracheostomy, to a group of recent historical controls for the treatment of amyotrophic     lateral sclerosis (ALS).   "
206334|NCT00542425|"     The purpose of this study is to determine whether BA058 is effective in building bone in     postmenopausal women with osteoporosis.   "
206335|NCT00542438|"     The specific aim of this study is to collect preliminary data on the feasibility and validity     of home-based data collection methods to measure four constructs:        -  Physical Activity: Real-time assessment using Ecological Momentary Assessment (EMA) and          pedometers        -  Cardiorespiratory Fitness: Step test        -  Anthropometry: Waist and hip circumference measurements        -  Environmental Variables: Examples include density of neighborhood physical activity          facilities (including gyms, parks, walking trails), crime, land use mix, and          transportation variables, collected by participants using EMA.   "
206336|NCT00542451|"     The purpose of this study is to find out what effect the postoperative combination of     therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer     recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node     positive and high risk node negative disease. This tests utilizes a well tolerated regimen of     weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2     positive. We would like to determine how effective this drug combination is when used in     women with early stage breast cancer, as well as to better define the side effects of this     treatment.   "
206337|NCT00542464|"     The study is a Phase Ib, randomized, double-blind, placebo-controlled, multiple-dose (7 day),     dose-escalation study assessing the safety, pharmacodynamics, and pharmacokinetics of     intravenous Imprime PGG™ Injection in healthy adult subjects.   "
206338|NCT00542490|"     The purpose of this study is to determine the progression-free survival of patients with     surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with     high-intermediate risk factors treated by vaginal cuff brachytherapy followed by     chemotherapy.   "
206339|NCT00542503|"     Flash pulmonary edema is a sudden, abnormal build-up of fluid in the lungs. It is usually     caused by heart failure and can be life threatening. The purpose of this study is to     determine if a new form of magnetic resonance imaging (MRI) can identify abnormal blood flow     to the lungs and predict increased risk of developing flash pulmonary edema among older     adults.   "
206340|NCT00542516|"     Currently the most use solution to volemic reposition in hip replacement arthroplasty is the     crystalloid solution. This trial intends to compare two different volemic replacements: HES     and Ringer's lactate. This research has been analyzing hemodynamic parameters and the     coagulation status before and after the pre-expansion with the solutions above mentioned.   "
206341|NCT00542529|"     This study is a randomized, placebo-controlled, dose-escalation, single-center study     evaluating two different doses of Imprime PGG, each in 7 different dosing regimes. A total of     66 subjects will be enrolled into 2 cohorts and, within each cohort, randomized to 1 of 7     treatment groups receiving Imprime PGG or placebo in varied dosing regimens with     granulocyte-colony stimulating factor (G-CSF).   "
206342|NCT00542542|"     Primary Objective:      To determine whether the use of a paravertebral block in patients undergoing reconstructive     surgery for breast cancer results in decreased immediate post-operative pain compared with     patients having only general anesthesia.      Secondary Objectives:        1. To determine whether the use of a paravertebral block in patients undergoing          reconstructive surgery for breast cancer results in decreased post-operative pain in the          first 24 hours after surgery compared with patients having only general anesthesia.        2. To determine whether the use of a paravertebral block in patients undergoing          reconstructive surgery for breast cancer results in decreased post-operative nausea and          vomiting in the first 24 hours as compared with patients having only general anesthesia.        3. To determine whether the use of a paravertebral block in patients undergoing          reconstructive surgery for breast cancer results in a decreased length of hospital stay          compared with patients having only general anesthesia.   "
206343|NCT00542555|"     To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of     signs and symptoms of Osteoarthritis.   "
206344|NCT00542568|"     The purposes of this study are to assess safety, efficacy, and subject satisfaction of     EPODURE Biopump (an autologous dermal biopump capable of sustained secretion of therapeutic     EPO in the body, using a small tissue explant from the patient's own skin) treatment in     Chronic Kidney Disease (CKD) patients over a period of up to six (6) months.   "
206360|NCT00542776|"     The purpose of this study is to compare the efficacy and safety of influenza vaccine in     patients with inflammatory bowel disease (IBD) on immunosuppressive therapy with IBD patients     on aminosalicylates and healthy historical controls.   "
206410|NCT00548938|"     The purpose of this study is to determine the safety and efficacy of the combination of     Gliadel wafers plus surgery and limited field radiation therapy with concomitant temozolomide     followed by temozolomide given at an extended dose schedule (metronomic schedule) in patients     undergoing initial surgery for newly-diagnosed high grade glioma.   "
206345|NCT00542581|"     The purpose of this study is to evaluate the visual outcomes and patient satisfaction after     implantation of a toric IOL in patients with predicted residual corneal astigmatism between     0.75 and 1.00 D.      Cataract is prevalent throughout the world and IOLs are routinely implanted after the     extraction of the cataractous lens. It is the most frequently performed surgery in the United     States with an estimated 2-3 million procedures performed annually. With the aging population     on the rise, as well as the increasing popularity of refractive intraocular lenses, the     number of intraocular surgeries continues to rise. Over the years, the surgical technique has     evolved from intracapsular extraction to modern phacoemulsification. This development has     helped with the evolution of IOLs as well. The IOLs have advanced extensively: different     materials and designs are available, permitting implantation through smaller, sutureless     incisions. Traditional IOLs are of monofocal design providing vision at one distance,     typically far; and correct mainly the spherical component of the refractive error. However,     there are patients with corneal astigmatism that require additional surgical treatment such     as laser correction (laser in situ leratomileusis, LASIK; photorefractive keratectomy, PRK)     or limbal relaxing incisions, RLI). Another alternative is the use of a toric IOL, which has     been especially designed to correct both the sphere and the astigmatism. The ACRYSOF Toric     IOL is intended for primary implantation in the capsular bag of the eye for visual correction     of aphakia and preexisting comeal astigmatism in adult patients with or without presbyopia,     who desire improved uncorrected distance vision, reduction of residual refractive cylinder     and increased spectacle independence for distance vision.      The treatment selection of the corneal astigmatism depends on the amount of cylinder as     follows, between 0.25 and 0.75 D creating the surgical incision on the steep axis; between     0.75 and 1.75 D, RLI; between 1 and 2.25 D, toric IOLs; and between 1 and 3.00 D, LASIK/PRK.   "
206346|NCT00542594|"     The purpose of this survey is to describe long-term tolerance as seen under current     conditions of use for anastrozole.   "
206347|NCT00542607|"     No information was yet available over the effect of levocetirizine in children under 12     years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and     safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis     due to house dust mites.   "
206348|NCT00542620|"     This trial is conducted in Europe. The aim of the trial is to compare two methods of     injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin     detemir associated with insulin aspart given twice daily in either separate or mixed     injections and to investigate if there is any clinical impact in choosing one regimen over     another.   "
206349|NCT00542633|"     The purpose of this study is to demonstrate equivalent blood glucose control in patients with     type 2 diabetes mellitus with insulin VIAject™ and regular human insulin as prandial insulin     and to demonstrate an equivalent safety profile for VIAject™ in comparison to regular human     insulin.   "
206350|NCT00542646|"     The occurrence of Peripheral Vascular Disease has been increasing which includes the large     artery in the upper leg called Superficial Femoral Artery (SFA). The Peritoneal Lined Stent     has been developed as a new method for treating narrowed area in the SFA. This research study     will determine the safety and effectiveness of the Peritoneal Lined Stent in keeping th     Superficial Femoral Artery open and allowing blood to flow in the leg.   "
206351|NCT00542659|"     The role of plasma NT-proBNP, hsCRP, TIMP-1(Tissue inhibitors of MetalloProteinase-1),TGF-b,     MMP-3(Matrix MetalloProteinase-3), and pro-MMP-1 in predicting the recurrence of AF after     surgical Maze procedure.      The association of expression of CTGF, TGF-b, BNP, ANP, collagen-1, and collagen-3 in LA with     the recurrence of AF after surgical Maze procedure.   "
206352|NCT00542672|"     Latino children in the United States have an increased risk of becoming overweight or obese.     Previous studies have suggested that parental behaviors are an important influence on     children's weight, but more research is needed on the types of behaviors that may contribute     to obesity specifically among Latino children. The purpose of this study is to examine the     connection between family eating habits and behaviors and obesity among Mexican-American     children.   "
206353|NCT00542685|"     This study will evaluate the efficacy and safety of PD 0332334 for the treatment of     generalized anxiety disorder.   "
206354|NCT00542698|"     The purpose of this study was to develop a nurse counseling intervention to increase physical     activity behavior in people with type 2 diabetes and to improve their health   "
206355|NCT00542711|"     Curcumin is a commonly-used spice and food coloring. Evidence suggests that curcumin can     suppress tumor initiation, promotion and metastasis in a variety of tumor cell lines. The     current available curcumin has low bioavailability restricting the effect of curcumin in     non-colon cancer. In this study we plan to test a new liquid tumeric/curcumin extract,     Curcumol (patent pending, Israel Patent Application No. 181,121). We predict the     bioavailability of the liquid tumeric/curcumin extract will be better compared to the     currently used curcumin powder.   "
206356|NCT00542724|"     The purpose of this study is to demonstrate equivalent blood glucose control in patients with     type 1 diabetes mellitus with insulin VIAject™ and regular human insulin as prandial insulin     and to demonstrate an equivalent safety profile for VIAject™ in comparison to regular human     insulin.   "
206357|NCT00542737|"     Acute lung injury/acute respiratory distress syndrome (ALI/ARDS) is a severe lung condition     that causes respiratory failure. Individuals with ALI/ARDS often require the use of a     respirator or artificial breathing machine, known as a mechanical ventilator, while in an     intensive care unit (ICU). Research has shown that lung protective ventilation (LPV), a type     of mechanical ventilation technique, is an effective way to reduce the number of deaths due     to ALI/ARDS. This study will evaluate the effectiveness of a Web-based educational program     that aims to educate ICU clinicians about the use of LPV in patients with ALI/ARDS.   "
206358|NCT00542750|"     The purpose of this pilot study is to determine the feasibility of conducting a trial of     N-Acetylcysteine in cannabis dependent adolescents.   "
206359|NCT00542763|"     Primary Sjogren's syndrome (pSS) is an autoimmune disorder characterized by     keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations     may develop. Several immunomodulating agents have been attempted in the treatment of pSS     without achieving satisfactory results. Currently, there is no approved systemic treatment     for pSS.      Mycophenolic acid (MPA) is a selective inhibitor of inosine-monophosphate-dehydrogenase which     leads to inhibition of the de novo pathway of nucleotide synthesis. The antiproliferative     effect of MPA mainly affects activated T- and B-lymphocytes because the proliferation of     these cells is critically dependent on the de novo purine synthesis compared to other     eukaryotic cells. Since these lymphocytes have been suggested to play a pivotal role in the     inflammation and immunopathogenesis of pSS, mycophenolate-sodium might be a promising agent     in the treatment of pSS.      We perform a single-centre, open-label pilot trial with Mycophenolate sodium in pSS.   "
210157|NCT00602186|"     The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the     treatment of female voiding dysfunction(BOO)   "
206361|NCT00542789|"     The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus     placebo once daily for up to 24 weeks of treatment involving patients with a history of     gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID)     therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the     treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal     ulcers   "
206362|NCT00542802|"     The principal purpose of the study is to determine the efficacy and safety of Levetiracetam     versus Carbamazepine, intended as the number of patients free from crisis during the whole     period of treatment, in patients affected by post stroke late onset crisis.   "
206363|NCT00542815|"     This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in     conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will     allow exposure to MCI-196 for up to 52 weeks   "
206364|NCT00542828|"     This is a Phase II, single-arm, open-label, multinational, multicenter study of rATG in     patients with low or intermediate-1 risk MDS who have either failed 1 prior treatment with     growth factor(s), hypomethylating agents (5-azacitidine or decitabine), or the antiangiogenic     agents lenalidomide or thalidomide, or who have never been treated for MDS (i.e.,     treatment-naïve patients).   "
206365|NCT00542841|"     Congenital adrenal hyperplasia (CAH) is a genetic disorder that affects the amount of     steroids that the body forms. The most common form of CAH is 21-hydroxylase deficiency     (21OHD), which leads to cortisol deficiency. This, in turn, causes the development of mature     masculine characteristics in newborn, prepubescent, and grown females and in prepubescent     males. 21OHD is known to be caused by the mutation of a specific gene. However, symptom     severity among people with 21OHD varies, and adults seem to be less affected than children.     This study will examine participants' DNA to determine what other genes may affect the     severity of 21OHD and may make the disease milder in adults than in children.   "
206366|NCT00542854|"     Unlike phones, which are commonly held to the ear, music is now available via portable MP3     players and they can be held almost anywhere. Thaker et al state that Apple iPods cause     pacemaker interference in 50% of their patients, with over-sensing in 20% of patients,     telemetry interference in 29% of patients and pacemaker inhibition in 1.2% of patients. The     mean age for their sample was 76.1 years +/- 8.6 years. We anticipate that a higher     proportion of teenagers and children who have pacemakers use portable MP3 players than in the     elderly adult population.We will include the first 100 patients with pacemakers and ICDs who     consent for the prospective observational study a single tertiary care center. We intend to     conduct a descriptive study, tabulating the number of times that a pacemaker or ICD has     changes in the sensing thresholds, pacing thresholds, telemetry interference or pacemaker     inhibition when exposed to a series of portable MP3 players at various distances. In     addition, we will describe the nature and quantitative differences of those changes.   "
206367|NCT00542867|"     The survey try to establish the proportion of patients on lipid-lowering pharmacological     treatment reaching the LDL-C goals according to the Third Joint European Task Force     guidelines, overall and by country.·   "
206368|NCT00542880|"     This study is to assess the effects with two different inhaled respiratory medications with     regards to improvement of lung function, symptoms and morning activities.   "
206369|NCT00542893|"     This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics     of dacarbazine(DTIC) when administered in combination with Genasense   "
206370|NCT00542906|"     The implication of the second somatosensory area (SII) and the insular cortex in the     processing of somatosensory inputs is now well established. However the functional anatomy of     these areas hidden in the depth of the sylvian scissure remain mostly unknown.      The aim of this fMRI study is to determine the functional cartography of SII and insula. The     localization of responses to different somatosensory stimuli (slight touch, warm, cold, heat     pain and arthrokinesia) applied on the left hand of 25 healthy volunteers, will be compared.   "
206371|NCT00542919|"     In this study, all patients will get investigational drug. There will be no comparator drug.     This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and     Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes:        -  T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL)        -  Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2)          and marginal zone lymphoma        -  Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and          aggressive lymphoma with prior clinical history of indolent lymphoma.   "
206372|NCT00542932|"     Patients with COPD, suffer symptoms of breathlessness and leg weakness. Exercise programmes     in the form of pulmonary rehabilitation (PR) have been shown to improve both of these     symptoms significantly. PR involves patients attending a hospital or community centre. For     some patients, leaving the house is an ordeal. This study investigated the effectiveness of     an exercise video programme delivered in the patients home.   "
206373|NCT00542945|"     The primary objective of this study is to determine the efficacy of ICD therapy compared with     control on the endpoint of death from any cause in patients with heart failure of     non-ischemic oetiology.   "
206374|NCT00542958|"     The purpose of this study is to determine whether NK012 is safe and effective in the     treatment of refractory solid tumors   "
206375|NCT00542971|"     A primary goal of this clinical research study is to find the highest safe dose of sorafenib     that can be given in combination with idarubicin and Ara-C for the treatment of acute     myelogenous leukemia (AML) and high-risk, myelodysplastic syndrome (MDS).      Once the highest safe dose is found, researchers will then try to learn if this combination     treatment can help control AML and high-risk MDS in newly diagnosed patients. The safety of     this treatment combination will also be studied.   "
206376|NCT00542984|"     To compare in postmenopausal women with established osteoporosis the effect of treatment with     teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day     subcutaneous on change in lumbar spine BMD.   "
206377|NCT00542997|"     The objective of this study is to assess the efficacy, tolerability, safety and     pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).   "
206411|NCT00548951|"     To determine the connection between Social Withdrawal and Sensory Deprivation in elderly     clients with Alzheimer's Type Dementia (i.e. how providing sensory stimulation might reduce     social withdrawal).   "
206381|NCT00543049|"     Ovarian cancer is most often recognized in advanced clinical state, the initial therapeutic     strategies consist of a platinum containing chemotherapy subsequent to primary surgery.     Although initially responsive to platinum-paclitaxel containing chemotherapy, a significant     number of patients will show tumor progression during first line chemotherapy or relapse     within six months after completion of first line chemotherapy, therefore being characterized     as chemotherapy resistant. Any second line chemotherapy will result in approximately 10% of     overall response, underlining the poor prognosis for these patients with an estimated median     overall survival of 20 weeks.      In addition to conventional chemotherapeutics, so called small molecules are of high interest     to establish new strategies in chemotherapy-refractory ovarian cancer (and in the long run     first line chemotherapy). SU11248 is a polytargeting tyrosine kinase inhibitor.      SU11248 has demonstrated clinical efficacy in kidney cancer and GIST, further clinical trials     have been initiated in other tumor entities. Growth pattern and biological targets present in     ovarian cancer indicate that SU11248 might be a promising compound for the treatment of     ovarian cancer. Especially, VEGFR, PDGFR and c-kit are specific targets for SU11248, which     are expressed in ovarian cancer. The different targets of SU11248 provide a potential     advantage of this compound compared to single-target molecules in chemotherapy-refractory     ovarian cancer.   "
206382|NCT00543062|"     To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval     duration) at 2 dose levels compared to placebo in healthy volunteers.   "
206383|NCT00543075|"     To characterize the pharmacokinetics of G3139 in subjects with normal, mildly impaired, and     moderately impaired renal function who receive Genasense 3 mg/kg/day by continuous     intravenous infusion for 2 days (48 hours).   "
206384|NCT00543088|"     Evaluating the effectiveness of atypical antipsychotics in the community - a prospective,     multicentre, observational study to evaluate the impact on Quality of Life of GP-based     management of antipsychotic treatment in Belgium   "
206385|NCT00543101|"     This study will evaluate patients who have achieved virologic suppression (< 400 copies/mL)     on any dual protease inhibitor (PI) combination, to determine whether patients can substitute     both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID)     and maintain comparable virologic suppression (% < 50 c/mL) for 24 weeks.   "
206386|NCT00543114|"     The purpose of this study is to determine the safety of lenalidomide (revlimid) in     combination with fludarabine and rituximab and to determine the highest dose of lenalidomide     that can safely be given in that combination. Lenalidomide is a drug that alters the immune     system and may also interfere with the the development of tiny blood vessels that help     support tumor growth. Lenalidomide is approved by the FDA for the treatment of two different     blood cancers called myelodysplastic syndrome and multiple myeloma. Lenalidomide has also     been studied in subjects with relapsed CLL. In this research study we are adding lenalidomide     to a well-established initial therapy for CLL/SLL.   "
206387|NCT00543127|"     Postmenopausal women with hormone receptor positive and negative Her2 tumours.      Estimation of the 5-year disease-free survival in the control arm is 80%. The experimental     arm is expected to increase the 5-year disease-free survival by 4% (up to 84%). With an alpha     error of 0.05 and 80% power, 1445 patients per arm are needed. Assuming a 10%     post-randomization drop-out, 3180 patients in total are needed.      Before randomization, the patients will be stratified according to the center, positive     nodes(0 vs. 1-3 vs. ≥4), previous chemotherapy (yes vs no) and hormonal receptors status.   "
206388|NCT00548639|"     Diabetes is a growing epidemic within the United States that disproportionately affects     economically disadvantaged communities like East Harlem. As diabetic patients are at very     high risk for heart disease, experts recommend an aggressive approach towards using statins     in people with diabetes. However, statins and other helpful drugs are only effective if     patients decide to take them. Adherence to this medication is notoriously poor and is     aggravated by its required life-long use. This study is designed to test the effectiveness of     a new decision aid in helping diverse, inner-city patients with diabetes understand the risks     and benefits in taking statins and whether this enhanced decision making process improves     their adherence to the medication.   "
206389|NCT00548652|"     The purpose of this study is to determine whether treating apathy with methylphenidate or     medical Crisis counselling will increase adherence to weight loss programs thereby increasing     their effectiveness   "
206390|NCT00548665|"     The purpose of this study is to determine the impact of carotid plaque screening on smoking     cessation and control of other cardiovascular risk factors.   "
206391|NCT00548678|"     This study will assess platelet function and safety in healthy male volunteers following     doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac     and oral aspirin.   "
206392|NCT00548691|"     The Objective of this study is to study the safety of FCM in patients with anemia caused by     chronic kidney failure   "
206393|NCT00548704|"     The purpose of this study is        -  To prevent progression of a lesion caused by anthracycline extravasation into necrosis,          which would require surgical intervention        -  To prevent development of deep tissue necrosis and destruction leading to impaired limb          function and neurological deficit        -  To prevent postponement of the scheduled cancer treatment due to the treatment of the          extravasation   "
206394|NCT00548717|"     This trial will test the hypothesis that the combination of sirolimus, mycophenolate mofetil,     and bortezomib will be effective in preventing both acute and chronic GVHD after reduced     intensity allogeneic stem cell transplantation.   "
206395|NCT00548730|"     The purpose of the study is to compare the three methods of bronchoscopic imaging to     determine what combination is optimum to identify neoplastic mucosal abnormalities. The     ability to decrease the rate of false-positive and false negative findings of bronchoscopy     also will be studied for each spectroscopic technique separately and for their combination.   "
206412|NCT00548964|"     As of May 21st, 2012, the purpose of this study is to test the antidepressant effect of     ketamine when given repeatedly over a period of 1 week, as well as the use of Lithium as a     relapse-prevention strategy for patients with treatment-resistant depression (TRD) who     respond to an initial series of ketamine infusions. Ketamine is a Food and Drug     Administration approved anesthetic (a drug used to produce loss of consciousness before and     during surgery). Ketamine is not approved for the treatment of major depressive disorder and     is considered experimental in this study.   "
206396|NCT00548743|"     This is a study to assess the impact of introducing screening and planned follow up for     postpartum depression. All women ages 18 to 45 who speak English or Spanish who come to the     enrolled community family medicine offices will either be given usual care or screened using     the Edinburgh Postnatal Depression Screening tool. If the EDPS score is high the women will     be given the PHQ-9 to more clearly identify the specific likelihood of being depressed. Women     who are determined to be depressed will be treated with medication or counseling based on the     preference of the women and their physicians. Women will be followed through nurse initiated     phone calls and visits to the physicians office.      Outcomes include the level of depression symptoms, measure of comfort with parenting, and     satisfaction with partner relationships comparing baseline levels with those at 6 and 12     months from the usual care and intervention sites. These data will be collected by     questionnaire. In addition, with the women's permission, medical records will be reviewed.   "
206397|NCT00548756|"     The goal of this clinical research study is to learn if your thinking ability (cognitive     function) will be better preserved by delivering whole brain radiation therapy immediately     after radiosurgical treatment of 1-3 brain metastases or to carefully observe patients after     radiosurgery and hold back whole brain radiation therapy until the disease comes back.   "
206398|NCT00548769|"     Sufficient subjects with a confirmed diagnosis of MS (EDSS score of 6.5 or below), will be     recruited to ensure that 30 subjects (approx. equal numbers of each gender) complete the     study. Subjects will undergo a screening visit, then four study days, each separated by a     washout period of at least 7 days, when the different firategrast batches of drug substance     will be administered, and a follow-up visit.   "
206399|NCT00548782|"     This study proposes to evaluate the physiological effects of eating Paleolithic type diet     (hunter-gatherer's diet) on Type 2 diabetic patients. The diet essentially consists of     fruits, vegetables, nuts, lean meats, excludes dairy products and grains.Subjects will be     randomized into taking either ADA (American Diabetic Association) recommended diet or     Paleolithic diet for 21 days. The research kitchen will provide all food items and total     calories in both groups will be adjusted to maintain baseline weight. Blood and urine test     will be done in the first 3 days, last 3 days and 1 month after the study period to study and     compare the effects of the two diets on subjects glucose control, lipid profile and other     parameters of cardiovascular physiology.      We hypothesize that a palaeolithic diet in subjects with Type 2 diabetes mellitis, will     result in improvement in above parameters and lead to improvement in glucose control with     less need for diabetes medicines (either lower doses or fewer medications) to a greater     extent than in subjects fed with ADA diet, without any change in weight. We also expect a     beneficial effect on blood vessel function, lipid profiles and blood pressure.   "
206400|NCT00548795|"     Acute respiratory distress syndrome (ARDS) is a severe lung condition that can result from a     bacterial infection in the lungs. Viral infections may impair the body's immune system     response to bacteria, which may lead to more serious lung injury. This study will evaluate     the association between the immune response and ARDS severity in people who have ARDS plus a     viral infection.   "
206401|NCT00548808|"     The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily     injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections)     on lowering the blood sugar level   "
206402|NCT00548821|"     The primary aim of this research protocol is to compare if there is a difference in     progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy     regimen in women with locally advanced cervical cancer. The secondary aims are to compare     quality of life assessment of patients and their carers as well as toxicity profiles both     acute and late.   "
206403|NCT00548834|"     The purpose of this study was to confirm and extend the data from previous studies and to     demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with     CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had     failed at least one DMARD.   "
206404|NCT00548847|"     The relapse of acute leukemia, MDS and blast phase CML after allogeneic transplantation     affects approximately 1/3 to 1/2 of all transplant recipients and is the main cause of     treatment failure. There is currently no effective standard treatment for this condition.      This study will test the activity and feasibility of using a regimen to boost the immune     system in order to treat AML, ALL, blast phase CML, and MDS relapse after allogeneic     transplantation.   "
206405|NCT00548860|"     The Objective of this study is to study the safety of FCM in patients with anemia caused by     Heavy Uterine Bleeding and the Post Partum state.   "
206406|NCT00548886|"     Long QT syndrome (LQTS)is a cardiac disorder that may lead to ventricular arrythmias and     culminate in syncope and/or possible death.      Recently, researchers have developed a way of discovering patients with LQTS by using low     doses of epinephrine by a continuous, intravenous infusion in adults. Epinephrine, or     adrenaline, is produced by our bodies in times of stress. By producing adrenaline, your body     allows itself to adapt to its stressful environment and take appropriate actions (i.e. fight     or flight response). By simulating this response with very small amounts of epinephrine,     researchers have shown prolongation of the QT interval does not occur in normal healthy     adults. However, adults with confirmed LQTS Type 1 (LQTS-1) will prolong their QT interval     when given low dose epinephrine. Therefore, this test can act as a safe means of identifying     adults with LQTS-1 who do not have prolonged QT intervals on their resting EKGs.      However, LQTS is not just a disease of adults, it affects children as well. Currently the     standard of care is to obtain resting EKGs on our pediatric patients which can miss those     patients with concealed LQTS. Those patients, who are old enough, can undergo exercise     testing. Yet this leaves young children unable to run on a treadmill without a diagnostic     test.      Hypothesis: The low-dose epinephrine infusion stress test does not cause prolongation of the     QT interval in an electrophysiologically normal healthy pediatric population.   "
206407|NCT00548899|"     The purpose of this study is to determine the efficacy and safety of sorafenib in the     neoadjuvant setting in patients with primary breast cancer   "
206408|NCT00548912|"     The hypothesis of this trial is to assess the effect of spironolactone on heart size and mass   "
206409|NCT00548925|"     The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose     of an investigational product in subjects with diabetic neuropathy   "
206413|NCT00548977|"     The proposed study is designed to test the following hypotheses:        1. Mouse autosomal or X-linked genes which are exclusively expressed in mouse spermatogonia          are also spermatogonia-specific in human.        2. Severe spermatogenic defect, especially hypospermatogenesis or SCOS, is caused by an          intrinsic defect in germ line stem cell or speramtogenia.        3. Spermatogonia-specific genes are caudate genes for human spermatogenic defect,          especially for hypospermatogenesis or SCOS.        4. For a significant fraction of cases with severe spermatogenic defect, the sterile genes          are transmitted via multifactorial inheritance mode.        5. For some cases with severe spermatogenic defect, mutations of spermatogonia- specific          genes may be transmitted in the X-linked recessive, autosomal recessive, or autosomal          dominant mode.   "
206414|NCT00549120|"     Optimising the propranolol block model   "
206415|NCT00549133|"     To show that Irbesartan improves endothelial dysfunction and the procoagulant state which are     thought to be the possible mechanisms, inducing a generalized vasculopathy associated with     microalbuminuria and vascular events in type II diabetic hypertensive patients   "
206416|NCT00549146|"     Relatively little information is available about the effects of salmeterol/fluticasone     combination and fluticasone alone in COPD patients with a partial reversible pulmonary     obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone     combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with     COPD on lung function over a 1 year period.   "
206417|NCT00549159|"     The purpose of study is to compare the treatment success in the study groups.   "
206418|NCT00549172|"     Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of     function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat     meniscal tears. Improvements have been reported both after arthroscopy and with conservative     treatment, however no direct comparison exist. Accordingly, the aim of this study is to     assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative     tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised     trial.   "
206419|NCT00549185|"     The primary objective is to determine the maximum tolerated dose of SAR3419 and to     characterize the dose limiting toxicity(ies). Secondary objectives are to determine the     anti-lymphoma activity, the global safety and the PK profile.   "
206420|NCT00549198|"     Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA     (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily     regimens. However data from head-to-head randomized trials comparing these two FDCs as part     of an initial regimen are not available at present. The long-term toxicity profiles of these     regimens are of particular importance, as treatment of HIV is currently life-long and     therefore, minimizing long-term toxicity and maximizing adherence and duration of regimen     maintenance are critical therapy objectives.      The primary endpoint is estimated glomerular filtration rate (GFR), as measured by the     modified diet in renal disease (MDRD) equation, a validated estimate of renal function.   "
206421|NCT00549211|"     A study conducted on healthy volunteers to determine the safety, tolerability and affect on     the human body by experimental drug GSK557296.   "
206422|NCT00549237|"     The aim of this study is to demonstrate the influence of peri-operative nutrition on the     preservation of lean body mass after gastric bypass, as well as it's influence on     postoperative complications.   "
206423|NCT00549250|"     Vertical transmission of human papillomavirus (HPV) 6/11 leads to infection in the lower     airway of neonates. The presence of HPV 6/11 may later cause juvenile onset recurrent     respiratory papillomatosis (JORRP).   "
206424|NCT00549263|"     This study will test whether the Drug levels in plasma after combination formulation tablet     dosing (SB797620) and separate formulation tablets dosing (rosiglitazone and glimepiride) to     Japanese Healthy volunteer would be the same or not.   "
206425|NCT00549276|"     This study aims to compare the safty and technical accessibility of linear stapler and curved     cutter stapler during mid to low rectal cancer surgery.   "
206426|NCT00549289|"     The purpose of this phase III, open-label study is to determine the safety and tolerability     of cyclosporine in the treatment of dry eye syndrome.   "
206427|NCT00549302|"     Study to determine the long term safety of tadalafil in patients with increased blood     pressure in the blood vessel that carries blood from the right heart to the lungs and to see     if it will keep the disease from getting worse.   "
206428|NCT00549315|"     The Valiant stent-graft system is a flexible, implantable vascular stent-graft endoluminal     device preloaded in a delivery system that is used to exclude thoracic aortic lesions     (thoracic aneurysms, thoracic dissections, penetrating ulcers, traumatic transections and     both traumatic and degenerative pseudoaneurysms.   "
206429|NCT00549328|"     This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small     molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects     with advanced (Stage IIIB or IV) non-small cell lung cancer.   "
206430|NCT00549341|"     The safety and efficacy of Mentor Purified Toxin, Botulinum Toxin Type A, Purified     Neurotoxin, injected intramuscularly into the neck, is being evaluated as a treatment for     painful and non-painful spasmodic torticollis/cervical dystonia. It is hypothesized that     treatment will decrease symptom severity and will not have any significant side effects.   "
206431|NCT00549354|"     The Bifurcated PowerLink System is intended to provide a permanent alternative conduit for     blood flow within a patient's abdominal vascular system, which excludes the aneurysmal sac     from blood flow and pressure.   "
206432|NCT00549367|"     To evaluate the effectiveness of nutrition education and dietary counselling to improve the     nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA)     attending an HIV treatment facility in Bangkok Thailand.   "
206433|NCT00549380|"     The ultimate purpose is to explore potential techniques to exclude aneurysms and provide     alternative conduit for arterial flow. The single center sponsorship is intended to provide     the investigators the potential to incorporate improvements in existing technology during the     course of the study thereby ultimately enhancing the potential for superior medical care of     patients suffering from these disease states.   "
211518|NCT00620906|"     The purpose of this study is to examine the effects of manipulation on sacroiliac joint     motion using a Polhemus motion capture system.   "
206435|NCT00549406|"     The ability to maintain balance and avoid falling is highly dependent on the ability to     locate objects and architectural features in the environment. This need to continually     monitor the environment as one moves about in daily life suggests a critical role for visual     attention, gaze control, and spatial memory, all of which are known to decline with aging. In     this study, the investigators will test the efficacy of a computer-based visual-training     program designed to improve the ability to rapidly extract information from the peripheral     visual field. It is expected that older adults involved in the visual training intervention     will improve the speed, accuracy, and effectiveness of reach-to-grasp balance-recovery     reactions evoked by sudden unpredictable balance perturbation.   "
206436|NCT00549419|"     The purpose of this study is to determine whether the early identification and more precise     intervention of goal-directed intraoperative plasma volume expansion and catecholamine     therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal     vital signs will improve postoperative organ function, in particular renal function, in     patients undergoing major abdominal surgery.   "
206437|NCT00549432|"     The purpose of the study is to evaluate the TALENT endoluminal stent-graft system in patients     with abdominal aortic aneurysms. The TALENT endoluminal stent-graft system is a flexible,     implantable endoluminal vascular device preloaded in a placement system that is used to     exclude abdominal aortic aneurysms.   "
206438|NCT00549445|"     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease. Azithromycin, an     antibiotic, may be beneficial at reducing the symptoms and severity of the disease. This     study will analyze previously collected study data to evaluate the anti-inflammatory     properties of azithromycin and determine how azithromycin affects the frequency and severity     of COPD exacerbations.   "
206439|NCT00549458|"     The objective of this randomized controlled trial is to determine whether a standardized     Pilates exercise program can effectively strengthen pelvic floor muscles when compared with     conventional pelvic muscle rehabilitation.      Urinary incontinence is a widespread problem that affects 10-40% of all ambulatory women and     pelvic floor muscle training is an effective treatment for this problem. However, its     efficacy is proportionate to the effort expended. Even among women who are diligent with     pelvic muscle rehabilitation, long term follow-up reveals that benefits are lost in the     absence of maintenance exercises.      While this intervention is effective, recent studies demonstrate that long term adherence to     treatment is low. As compliance appears to be a prerequisite to achieving sustained benefit,     finding a method of pelvic muscle strengthening that better lends itself to long term     commitment could prove beneficial.      The currently popular exercise program, known as Pilates (named after founder, Joseph     Pilates) consists of a series of low impact, flexibility and muscle toning exercises. The     philosophy centers around developing core strength which includes strengthening the pelvic     floor. Its use has been described in the US since the 1920s.4 Five million Americans     currently participate, as opposed to five thousand ten years ago.5 Given its mainstream     popularity, Pilates would be an appealing as a therapeutic modality for women experiencing     pelvic muscle weakness. Currently, there are no studies that assess the efficacy of Pilates     in increasing pelvic muscle strength.   "
206440|NCT00549471|"     Hypothesis: (1) Treating upper limb hypertonia/spasticity with Botox®, in addition to     reducing hypertonia/spasticity, will (a) improve global development, (b) improve function     (passive & active), (c) reduce carer burden and (d) improve quality of life. (2) Early     treatment with Botox® will have a greater impact on the rate of global development when     compared to late treatment.   "
206441|NCT00549484|"     Infants who have low platelets and who require a platelet transfusion are included in this     study. Platelet transfusions are routinely given to infants when their platelet count falls     below a certain level. The study will look at the amount of platelets transfused. The purpose     of the study is to evaluate the effect of platelet transfusions on the level of a protein     (thrombopoietin) which is known to help control platelet production.   "
206442|NCT00549497|"     GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids     but is also less potent. This study will look at higher doses to confirm the improved safety     profile.   "
206443|NCT00549510|"     This will be an open-label, single-dose, non-randomized, five-period crossover study in     healthy volunteers. The duration of the study will last up to eleven weeks from screening to     follow-up. PK samples will be taken.   "
206444|NCT00549523|"     The study is a 2-stage, double-blind, randomized, placebo-controlled study in which fifty-six     HIV-positive subjects will be randomized into the first stage. Interim analysis to determine     continuation to stage 2 will be performed to determine continuation after 8 subjects per arm     have completed a 24-week dosing regimen.      Primary objectives are to determine the safety of Lessertia frutescens when used by HIV-1     infected adults with early disease, and to document the impact of Lessertia frutescens on     markers of HIV disease progression. Secondary objective is to determine the effect of     Lessertia frutescens on quality of life in HIV-infected adults and length of infection.   "
206445|NCT00549536|"     Increased levels of intracellular calcium are thought to diminish maximal cellular response     to insulin and induce insulin resistance. Also, both hypertension and diabetes are thought to     be conditions of altered intracellular ionic state. The aim of the present study is to     investigate the possible effect of oral calcium supplementation on intracellular ions,     insulin sensitivity, 24-h blood pressure and sodium/hydrogen exchanger activity in patients     with type 2 diabetes and essential hypertension.   "
206446|NCT00549549|"     This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that     will include an 8-day treatment period followed by a 1-week follow-up period in patients     experiencing symptoms of an acute exacerbation of gouty arthritis.   "
206447|NCT00549562|"     This 8-week, prospective open-label study will investigate the effectiveness and tolerability     of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er     will be well tolerated and efficacious for reducing aggression, self-injury, and irritability     in adolescents and young adults.   "
206510|NCT00550394|"     The purpose of this research study is to study the effects (both good and bad) of combining     quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of     elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor     judgment, reckless behavior) and to study the effects (both good and bad) of combining     quetiapine and topiramate for reducing use of alcohol.   "
206448|NCT00549575|"     Although there is a strong rationale to supplement gravid patients suffering intrauterine     growth restriction (IUGR) or preeclampsia with Arginine or other nitric oxide donors,     evidence in the literature has been inconclusive. The current study was designed to determine     whether oral treatment with L-Arginine, a nitric oxide (NO) donor, would enhance birth weight     and/or decrease neonatal morbidity in pregnancies with severe vascular intrauterine growth     restriction (IUGR).   "
206449|NCT00549588|"     Polymorphic light eruption (PLE) is a common photodermatosis characterized by the appearance     of itching, erythema, papules or vesicles on sun-exposed skin. Though etiology is unclear it     is hypothesized that it is an abnormal immune response to autologous antigens generated by     ultraviolet radiation (UVR). This randomized, double blinded left-right body side     experimental comparison study was designed to assess the preventive effect of a sunscreen and     topical DNA repair enzyme-containing after-sun lotion in PLE.   "
206450|NCT00549601|"     This study used two doses of rivastigmine transdermal patch (5 cm^2, 10 cm^2) to establish     the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or     without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5     mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability,     convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.   "
206451|NCT00549614|"     The primary objective of this study is to evaluate whether metabolic modulation improves left     ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in     chronic heart failure   "
206452|NCT00549627|"     The aim of the study is to determine the relative effectiveness of the PediGuardTM , a device     manufactured by SpineVision, Inc, for placement of a pedicle screw pilot (drill) hole and for     reducing pedicle screw breaches during thoracic and lumbar pedicle screw fixation of the     spine.      Hypothesis #1 The PediGuardTM will be more accurate for pedicle screw placement as compared     to other standard manual techniques of similar size of pedicle screw insertion. At least 90%     of screws placed with the PediGuardTM will be positioned correctly in the pedicle (defined as     less than 2 mm breach by CT scan). In contrast, only 80% of screws using manual placement     will be positioned correctly in the pedicle.      Hypothesis #2 The PediGuardTM will not be inferior to fluoroscopic techniques for pedicle     screw insertion. Both techniques will achieve at least 90% accuracy in the placement of     pedicle screws.   "
206453|NCT00549640|"     Cigarette smoking continues to be a major public health problem. Tobacco dependence     interventions, as recommended by the USPHS Clinical Practice Guideline are not effective for     all smokers. A need exists for new medications to treat various aspects of tobacco     dependence, such as the reinforcing effects of nicotine, relief of nicotine withdrawal     symptoms and prevention of early relapse. The neurobiology of the effect of methylphenidate     is similar to that of the reinforcing effects of nicotine. In a small previous study,     methylphenidate was reported to improve nicotine withdrawal symptoms and short term quit     rates. Methylphenidate is well tolerated, has low abuse potential, and is less expensive     compared to other tobacco dependence interventions. ConcertaTM, a long acting preparation of     methylphenidate, is administered once a day, has similar bioavailability as the generic drug     administered 3 times a day and has an overall similar or improved efficacy compared to     generic methylphenidate. We plan to obtain preliminary efficacy data in a randomized,     placebo-controlled phase II study assessing the effect of methylphenidate in cigarette     smokers for increasing 7-day point prevalence smoking abstinence at end of treatment and     7-day point prevalence and prolonged smoking abstinence at 6-months. Critical and systematic     evaluations of newer, innovative, and well-tolerated treatments to help treat tobacco use and     dependence will provide a wider choice of therapeutic agents to smokers wishing to become     abstinent from tobacco use.   "
206454|NCT00549653|"     This study is being conducted to provide initial safety and tolerability data as well as to     provide PK data on potential interactions when GW856553 and rosuvastatin are co-administered     in healthy male adults   "
206455|NCT00549666|"     A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen   "
206456|NCT00549679|"     This study will evaluate the safety and tolerability of the cfor the first time in mild to     moderate COPD patients.   "
206457|NCT00549692|"     The purpose of this study is to compare omega-3 fatty acids with placebo for efficacy in     retardation of increase of serum creatinine(SCr) in IgA Nephropathy   "
206458|NCT00549705|"     Registry of Hospitalized patients at Brigham and Women's Hospital treated with Fondaparinux   "
206459|NCT00549718|"     Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This     clinical study is designed to test the hypothesis that lurasidone is more efficacious than     placebo. The study will also evaluate the safety and tolerability of lurasidone as compared     to placebo.   "
206460|NCT00549731|"     The purpose of this study is to create a subject database to recruit for current and future     studies in research on autism and other neurodevelopmental disabilities.   "
206461|NCT00549744|"     Subjects will attend the unit for out-patient visits on Day 1, Day 7, Day 14 and Day 15 of     each treatment period. The washout period between each treatment period will be a minimum of     10 days and maximum of 28 days. Subjects will participate in 3 treatment periods.   "
206462|NCT00549757|"     The purpose of this study was to determine whether, in patients with type 2 diabetes and     pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at     a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment,     reduces death and disease caused by the heart, the circulatory system and the kidney.      AMENDMENT 4 RATIONALE (MARCH 2012) :      Protocol amendment 4 served to address the data monitoring committee recommendation dated 14     Dec 2011 to discontinue study treatment in all participating patients. It also addressed the     subsequent Health Authorities request to implement a 12 month safety follow-up period (actual     duration was 9 months in average) post study drug discontinuation.   "
206463|NCT00549770|"     This study was a dose-ranging efficiacy study in patients with essential hypertension to     assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and     placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to     placebo.   "
206853|NCT00556426|"     This study was designed to assess the safety of retrieval of the Bard Recovery® G2® Filter     System. The G2 filter is an FDA-cleared device for inferior vena caval interruption in     patients with pulmonary thromboembolism.   "
206464|NCT00549783|"     This is a study to investigate if patients who have had a stroke and suffer from spasticity     might benefit from being given BOTOX® in addition to the normal Standard Care. Spasticity is     characterized by stiffness or frequent cramps accompanied by pain and abnormal movements and     can prevent the carrying out of everyday tasks such as walking and getting dressed. BOTOX® is     a neurotoxin, which is used to prevent the contraction of muscle fibre and has been shown to     reduce spasticity significantly. Patients will be enrolled in this study at about 33     locations in Europe and Canada. Study participation will last for about 1 year.   "
206465|NCT00549796|"     Angioplasty is a procedure which opens blocked heart arteries using balloons and/or stents.     Most U.S. states and all national heart organizations require that angioplasty be done only     at hospitals that can also perform open heart surgery. The reason for this is that there is a     risk that angioplasty can cause injury to the heart artery that might require open heart     surgery to fix. Open heart surgery is a backup in case it is needed. The risk that open heart     surgery will be needed is very small. Nevertheless, without more research, many state     Departments of Health and all national heart organizations do not want to change the     requirement for having on-site open heart surgery wherever angioplasty is performed. Some     States already allow this; and European heart organizations already allow it, as well.      This study is designed to determine whether the safety and benefits of angioplasty are the     same at hospitals that perform angioplasty either with or without open heart surgery backup.      Patient who enter the study have a heart catheterization at a hospital without a heart     surgery program. If they need angioplasty, then they are randomized to either stay at the     hospital without heart surgery for their angioplasty or to be transferred for the procedure     to a hospital with heart surgery. For every four patients, three stay at the hospital without     heart surgery and one is transferred.      The study is designed to show that there is no detectable difference between the safety and     benefits of the procedure at the two types of hospital (with and without heart surgery). The     cost of the procedure at the two hospital types is also compared.   "
206466|NCT00549809|"     Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent     mandatory ventilation associated with pressure support (SIMV/PS) related to duration of     mechanical ventilation/weaning and length of stay in PICU (LS). Design: randomized clinical     trial. Setting: Pediatric intensive care unit at a university-affiliated hospital.   "
206467|NCT00549822|"     The purpose of this research study is to study the effects of using aromatase inhibitor (AI)     therapy intermittently on participants with breast cancer. AIs are a class of drugs used to     treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen,     which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses     despite therapy with an AI is thought to have become resistant to AI therapy. There is     scientific evidence to suggest that resistant breast cancer cells learn to grow at the very     low levels of estrogen present on AI therapy, and that increasing estrogen levels even     slightly by stopping AI therapy may inhibit the breast cancer cells.   "
206468|NCT00549835|"     This research is being done to see if acupuncture helps relieve mucositis pain in patients     with leukemia who are undergoing chemotherapy. Many patients receiving chemotherapy develop     mucositis (painful sores or blisters in the mouth or throat). Mucositis is not only a     frequent complication in cancer care and extremely painful, but also increases the risks of     infection and malnutrition and often leads to discontinuing or delaying the chemotherapy     treatments.   "
206469|NCT00549848|"     The primary objective of this study (TOTXVI) is to compare the clinical benefit, the     pharmacokinetics, and the pharmacodynamics of polyethylene glycol-conjugated (PEG)     asparaginase given in higher dose (HD PEG) versus those of PEG-asparaginase given in     conventional dose (CD PEG) during the continuation phase.      This study has several secondary objectives:      Therapeutic Objectives:      To estimate the event-free survival and overall survival of children with ALL who are treated     with risk-directed therapy.      To study whether intensifying induction, including fractionated cyclophosphamide and     thioguanine, in patients with day 15 MRD > 5%, will result in improved leukemia cytoreduction     in this subgroup compared to TOTXV.      To assess whether intensification of central nervous system (CNS)-directed intrathecal and     systemic chemotherapy will improve outcome in patients at high risk of CNS relapse.      Exploratory Pharmacologic Objectives:      To identify pharmacogenetic, pharmacokinetic and pharmacodynamic predictors for     treatment-related outcomes in the context of the systemic therapy used in the protocol.      To compare the pharmacokinetics and pharmacodynamics of PEG-asparaginase given in higher dose     (3,500 or 3,000 units/m2) versus those of PEG-asparaginase given in conventional dose (2,500     units/m2) in the continuation phase.      Exploratory Biologic Objectives:      To determine the prognostic value of levels of minimal residual disease in peripheral blood     at day 8 of remission induction.      To validate new markers and methods for MRD detection. To genotype natural killer (NK) cell     receptors and measure their expressions at diagnosis and before reinduction, and to associate     these features with treatment outcome.      To identify new prognostic factors by applying new technologies to study patient material     (e.g., stored plasma, serum, cerebrospinal fluid, and normal and leukemic cells).      Exploratory Neuroimaging Objectives:      To use quantitative MR measures (Diffusion Tensor Imaging and high resolution volumetric     imaging) to assess differences in myelin and cortical thickness development in patients     treated for ALL relative to healthy controls matched for age and gender.      To assess the impact of folate pathway genetic polymorphisms on myelin and cortical thickness     development and neurocognitive performance.      To assess the impact of frontal-parietal lobe myelin and cortical thickness development on     neurocognitive performance in attention, working memory, fluency, visual-spatial reasoning     and processing speed.   "
206470|NCT00549861|"     Different studies have shown that fibrosis of the heart increases the risk for a sudden death     from e.g. arrhythmias. Magnetic Resonance Imaging (CMR) can easily identify even small areas     of fibrosis in the heart muscle after contrast agent application (Gadolinium). With the     development of faster scanners and new contrast agents, the detection of small fibrotic areas     may even be improved.      In this study, we will apply dedicated T1- and T2-weighted CMR sequences before and after     administration of Gadolinium-based contrast (Gadobutrol, Gadovist(r)), the study parameters     will be full cardiac function, areas of edema, areas of inflammation and areas of fibrosis.      We hypothesize, that we can detect fibrotic areas in the myocardium using Gadobutrol     (Gadovist (r)) better than with the commonly used Gadolinium-DTPA contrast agents. We also     hypothesize, that fibrosis of the myocardium is correlated to prognosis of the patients.   "
206471|NCT00549874|"     The overall hypothesis to be tested is that increased insulin resistance contributes to     abnormal cardiac blood flow regulation in type 2 diabetic patients, which can be reversed by     6 months treatment with rosiglitazone. The planned experimental approach will be to utilize     nuclear medicine techniques to evaluate whether the administration of rosiglitazone for 6     months can reverse regional deficits in myocardial blood flow and glucose utilization in type     2 diabetes in a randomized double blind controlled study. These studies will help elucidate     the potential of rosiglitazone to correct deficits of myocardial blood flow complicating     diabetes with the overall aim being the eventual prevention of sudden cardiac death.   "
211583|NCT00621764|"     Safety:      To describe the safety profiles following vaccination.      Immunogenicity:      To describe the immune response after a single dose of vaccine.   "
206472|NCT00549887|"     The purpose of this study is to estimate the direct costs associated with switching, in     either direction, between a rapid-acting analog therapy and short-acting human insulin     therapy within the first year following the switch. The additional goals are: 1)to assess the     impact of a switch from or to a rapid-acting analog insulin therapy on patient treatment     satisfaction, 2) to assess the impact of a switch from or to a rapid-acting analog insulin     therapy on patient quality of life, 3) to assess the impact of switch from or to the     rapid-acting analog insulin therapy on the quality of metabolic control and, 4) to estimate     the total costs (direct and indirect) associated with switching, in either direction between     rapid-acting analog and short-acting human insulin within the first year following the     switch.   "
206473|NCT00549900|"     A phase I, open label, single-centre study to evaluate the safety and immunogenicity of     GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM),     administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female     subjects aged 15 - 45 years.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
206474|NCT00549913|"     This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety,     and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated,     allogeneic MPCs (NeoFuse) when combined with MasterGraft Resorbable Ceramic Granules     (Medtronic Sofamor Danek USA, Inc.) compared to autograft in patients requiring posterior     lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage (to be used with     autologous bone graft material) and 1 or 2 level posterolateral lumbar fusion surgery with     instrumentation. The instrumentation used for this study will be the Monarch® 5.50 mm Spine     System (DePuy).   "
206475|NCT00549926|"     The purpose of this study is to compare the effects of fluvastatin, pravastatin,     pitavastatin, and atorvastatin on coronary plaque volume in patients with acute coronary     syndrome, and to clarify the impact of moderate and intensive lipid lowering therapy on     coronary plaque volume, serum lipids, and inflammation markers in patients with acute     coronary syndrome in Japanese.   "
206476|NCT00549939|"     The primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to     Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of     age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O.      Secondary objectives were:        -  To investigate the safety and tolerability of two doses of Alfuzosin in comparison to          Placebo in children and adolescents,        -  To evaluate the effects of the two doses of Alfuzosin in comparison to Placebo on:             -  Detrusor compliance,             -  Urinary tract infection,        -  To investigate the pharmacokinetics of Alfuzosin (population kinetics),        -  To evaluate the 12-month long-term safety of Alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day.      The study consisted of 2 periods:        -  a 12-week double blind treatment period where patients were to receive either Alfuzosin          0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day or placebo then,        -  a 40-week open label extension treatment period where patients were to receive either          Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day.   "
206477|NCT00549952|"     to survey oral mucositis after chemotherapy and Concurrent chemoradiotherapy in Korean cancer     patients   "
206478|NCT00549965|"     Compare subject satisfaction of once a week dosing of 35 mg Risedronate to once daily dosing     of 5 mg Risedronate in postmenopausal osteoporotic women. Secondary objectives are to measure     compliance (50 % drug taken), and persistence.   "
206479|NCT00549978|"     to investigate the safety and pharmacokinetics, in healthy adult male subjects   "
206480|NCT00549991|"     High blood pressure is one of the most common health problems in the United States. Genetic     variations may cause some people to be more susceptible to developing high blood pressure.     This study will identify variations in genes known to play a part in the development of high     blood pressure.   "
206481|NCT00550004|"     This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of     six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic     pancreatic cancer. The study will be conducted at approximately 55 sites in the North     American, Europe, and South America. Approximately 153 subjects will be enrolled in a     randomization (ratio 2:1).   "
206482|NCT00550017|"     The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493)     in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate     (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian,     renal or breast cancer (in Phase 2 portion)   "
206483|NCT00550030|"     Etanercept, a biological antipsoriatic drug with anti-tumor-necrosis factor (TNF) activity     has been approved for the treatment of moderate to severe psoriasis. However, in a     substantial portion of cases etanercept does not induce reduction in psoriasis area and     severity index (PASI) of 75% or greater, now being considered as gold standard for treatment     efficacy. In this study the researchers aim to determine in a randomized half-side     comparison, whether additional narrowband UVB-311nm phototherapy accelerates and improves the     therapeutic efficacy of etanercept.   "
206484|NCT00550043|"     The purpose of this study is to understand the safety and tolerability of INCB018424 in     patients with rheumatoid arthritis   "
206485|NCT00550056|"     The study is a pragmatic trial to study the efficacy of two active methods of psychotherapy     for the treatment of posttraumatic stress disorder in a refugee camp in Africa. Treatment was     administered by lay counsellors.   "
206486|NCT00550069|"     Late preterm infants are at an increased risk for short and long term morbidity (during the     1st year of life, their neurodevelopmental status may also be delayed as compared to infants     born at term). The term near term infants is probably a deceiving one.   "
206487|NCT00550082|"     Evaluation of physician responses to BICS-Clinical Information 3-screen alerts that informs     the clinician that his/her patient may be eligible for thromboprophylaxis.   "
206488|NCT00550095|"     This study is designed to assess the efficacy of the different dosage forms of Valsartan[80,     160, and 320 mg] in reducing microalbuminuria/proteinuria in hypertensive patients with type     2 diabetes.   "
206489|NCT00550108|"     The purpose of this study is to determine the natural history of pancreatic cysts and to     determine if these cysts can be effectively treated with a less invasive therapy (ethanol     injection vs periodic imaging) rather than surgical resection   "
206491|NCT00550134|"     Patients with cancer often complain that their mind does not seem to be clear. This can be     due to stress, depression, anxiety, or physical problems caused by cancer or the treatments     used to control symptoms. There are many purposes for this study; one of them is to learn     about the effects of cancer treatments on the brain, and another is to identify useful tools     to detect these effects. The results of this study may stimulate new research comparing     different treatments to the current treatment so the researchers may learn how to treat     symptoms more effectively and improve patient quality of life. We would also like to learn     more about the effects chemotherapy may have on DNA.   "
206492|NCT00550147|"     The primary purpose of this thirteen-week, open-label study is to test the hypothesis that     quetiapine in combination with Oros methylphenidate will reduce aggressive symptoms in     children and adolescents who have shown inadequate response to OROS methylphenidate alone.   "
206493|NCT00550160|"     This cluster randomised trial is proposed to assess the clinical impact of adding a seasonal     intermittent preventive treatment (IPTc) schedule for children aged 3 -59 months to a home     management of malaria (HMM) programme using AQ+AS in Ghana. The study will be conducted in     the Kwaso sub district of the Ejisu-Juaben district of Ghana in which 6 communities will be     randomised to implement an IPTc schedule alongside the HMM programme or HMM programme alone.      The study will run in three phases; a preparatory phase to set up and obtain baseline     morbidity data from a cross-sectional survey; an intervention phase and a post intervention     phase of cross-sectional survey and data evaluation and dissemination. A cohort of 546 study     children randomly selected will receive three full treatment courses of AS+AQ intermittently     during the April - Nov 2007 transmission season. Community-based drug distributors (CDDs)     will administer all courses of IPTc. The first dose of each course will be directly observed     by the CDDs who will educate mothers or caregivers to administer subsequent doses     appropriately at home. Follow up visits to homes will be done by CDDs and field supervisors     to ascertain adherence and to monitor adverse drug events. The incidence of clinical malaria     and other secondary outcomes will be compared with those of another cohort of 546 study     children who will not receive IPTc but may be treated under the HMM strategy alone with AS+AQ     when necessary during the observation period.   "
206494|NCT00550173|"     The purpose of this study is to compare the combination of erlotinib and pemetrexed versus     either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time     until the objective worsening of the disease) in patients who have never smoked and have     locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a     first-line chemotherapy treatment.   "
206495|NCT00550186|"     The purpose of this study is to assess the influence of different fluid infusions on the     quantity of bladder retention after spinal anesthesia. This study should determine if this     increase in bladder retention is significant and relevant.   "
206496|NCT00550199|"     This will be a single center phase I dose escalation trial. LBH589 will be administered     orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days     1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will     be enrolled at each dose level. If 1/3 patients experiences dose-limiting toxicity, the dose     level will be expanded to 6 patients. If 2/6 patients experience dose-limiting toxicity at a     specific dose level, then the previous dose level will be considered the recommended phase II     dose. Dose escalation will continue until the maximum tolerated dose is determined or until     all dose levels outlined in the protocol have been completed. A total of 10 patients will be     treated at the dose that is recommended for further phase II evaluation to further assess the     safety of the combination regimen. Toxicity assessments will be ongoing and disease     assessments will be repeated every 2 treatment cycles. Patients will be allowed to continue     on study until disease progression unless toxicity warrants drug discontinuation.   "
206497|NCT00550212|"     The purpose of this study is to evaluate the mass balance and metabolic distribution of     C14-labeled HKI-272 in healthy male subjects.   "
206498|NCT00550225|"     Salt Bridging study for GSK961081   "
206499|NCT00550238|"     To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's     disease psychosis.   "
206500|NCT00550251|"     Pilot study completed - power calculation performed. Now formal double blind randomized study     comparing active with placebo wristbands for nausea in palliative care patients to be carried     out.   "
206501|NCT00550264|"     Patients admitted to inpatient medicine services often require early hospital readmission,     and often they are readmitted to different physician or team, potentially without the     knowledge of the prior physician or team. Thus, physicians may lose the opportunity to share     valuable information about readmitted patients, which may be detrimental to continuity of     care and patient safety. The purpose of this study is to determine baseline awareness and     communication rates among physicians regarding readmissions, and then measure the effect of     automatic notification on these rates.   "
206502|NCT00550277|"     Inhibition of histone deacetylase (HDAC) provides a novel approach for cancer treatment.     LBH589, an oral HDAC inhibitor, has been well tolerated in phase I trials and has shown     activity against several types of cancer. In this nonrandomized phase II trial, we are     investigating the activity of LBH589 in the treatment of patients with refractory clear cell     renal carcinoma.   "
206503|NCT00550290|"     This randomized prospective study will specifically investigate the efficacy of a 24 hour     post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in     preventing wound infection and wound breakdown following vulvectomy.   "
206504|NCT00550303|"     The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen     formulations for future testing purposes.   "
206505|NCT00550329|"     The objective of this study is to determine the bioequivalence of Glipizide GITS (Glucotrol     XL) 2.5 mg tablets manufactured at the Brooklyn, New York facility versus tablets     manufactured at the facility in Barceloneta, Puerto Rico.   "
206506|NCT00550342|"     The purpose of this study is to determine whether the approved drug, rituximab, is effective     in the treatment of focal segmental glomerulosclerosis (FSGS)   "
206507|NCT00550355|"     This study is designed to evaluate the safety and tolerability of multiple intravenously     administered doses of PD 0360324 in patients with rheumatoid arthritis receiving     methotrexate.   "
243377|NCT01041378|"     The purpose of this study is to evaluate postoperative pain control for pediatric patients.   "
206511|NCT00550407|"     This study is planned to objectively assess the efficacy and safety of lamotrigine     maintenance therapy after symptoms of mood episode had been stabilised by open-label     treatment with lamotrigine alone or in combination with other psychotropic medication in     patients with bipolar I disorder.   "
206512|NCT00550420|"     This is a Phase III, multicenter, open-label extension, single-group study in male and female     outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed AVA105640. All     subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4     weeks of the study followed by 8mg RSG XR. Subject participation will last until one of 5     conditions applies. After a 52-week open-label treatment phase, subjects will attend a final     Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to     evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD     who have completed AVA105640. The secondary objective of this study is to explore further the     long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as     a function of apolipoprotein E (APOE) e4 allele status   "
206513|NCT00550433|"     The purpose of this clinical trial is to study the blood levels of a drug (conjugated     estrogens) in the body from one dosage form compared to another. The four formulations of the     study drug that eligible participants will receive will contain the same amounts of the same     medications. In addition, information will also be obtained regarding the safety and     tolerability of the formulations given to healthy postmenopausal women.   "
206514|NCT00550446|"     The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5     doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of     seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®)     and one out of seven will only receive inactive substances (placebo.)   "
206515|NCT00550459|"     Demonstrate an improvement in the composite scores of validated neurocognitive tests in     elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.   "
206516|NCT00550472|"     The study was performed to investigate the effects of a probiotic supplementation containing     Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 and Bifidobacterium animalis     subsp. lactis DGCC 420 (B. lactis 420) on clinical, immunological and faecal parameters in     healthy volunteers and in patients with atopic dermatitis (AD).   "
206517|NCT00550485|"     The ABCB1-gene product P-glycoprotein is an integral membrane protein that actively     transports substrates out of the intracellular compartment. One of the major sites of its     action is the blood-brain-barrier. It is highly expressed in brain capillary endothelial     cells and involved in limiting the access of substrates such as antidepressants to the CNS. A     single nucleotide polymorphism (SNP) of the ABCB1-gene was recently identified showing a     different treatment response to antidepressant drugs depending on the genotype. Therefore, it     is assumed that healthy subjects with different genotypes of that SNP will be associated with     significantly different brain levels of the antidepressant escitalopram after 6 days of     intake. For determining intracerebral escitalopram levels, a 19-F magnetic resonance     spectroscopy will be used. Sleep recordings are a useful bio-marker for effects of     antidepressants on the CNS. Selective 5-HT1-reuptake inhibitors (e.g. escitalopram) cause a     suppression of REM sleep and a stronger fragmentation of sleep compared to untreated     subjects. Higher plasma levels of antidepressants affected the sleep to a greater extent than     lower levels. In line with this finding, we suppose that sleep EEG recordings of healthy     subjects with different genotypes of the above mentioned SNP will be differently affected     after taking 6 days escitalopram. In addition, there is good evidence that sleep is involved     in various forms of memory processing. For example, it has been repeatedly shown that the     performance in motor tasks (procedural learning) is correlated with the amount of stage 2     NonREM and REM sleep, respectively. Hence we hypothesize, that a drug-induced impairment of     sleep (e. g. reduction of REM sleep) is associated with an impairment of procedural learning.     In addition, effects of drug intake on the gene expression in lymphocytes and metabolic     changes will be assessed. Functional magnetic resonance imaging will be applied to detect     potential drug-induced changes of corticolimbic circuitries.   "
206518|NCT00550498|"     The purpose of this study is to find if autologous stem cell transplantation can stop the     progression of intractable eye lesions of Behcet's Disease or even to improve it.   "
206519|NCT00550511|"     The purpose of this study is to evaluate whether surgeon-performed ultrasound as a supplement     to clinical investigation when a patient presents with abdominal pain in the emergency     department can improve the management of the patient.   "
206520|NCT00550524|"     The purpose of this study is to find if autologous stem cell transplantation can improve     clinical manifestations of knee osteoarthritis.   "
206521|NCT00550537|"     RATIONALE: Studying samples of tumor tissue, blood, and urine in the laboratory from patients     receiving erlotinib may help doctors predict how patients will respond to treatment.      PURPOSE: The phase II trial is studying proteomic profiling to see how well it predicts     response in patients receiving erlotinib for stage IIIB, stage IV, or recurrent non-small     cell lung cancer.   "
206522|NCT00550550|"     The purpose of the study is to investigate the efficacy and safety of a grass sublingual     tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis     with or without asthma.   "
206523|NCT00550563|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This clinical trial is studying changes in DNA that affect vitamin D metabolism in     patients with colorectal cancer receiving vitamin D supplements.   "
206524|NCT00550576|"     Subjects suffering from bipolar disorders treated with specific medications will give their     informed concent and will receive intravenously only one dose of Digoxin antibodies (Fab).     Their response to this therapy will be measured accordingly.Previous medications will be not     changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured     using a specific laboratory technique and these compounds will be measured at 6 and 24 hours     after Fab therapy.      Patients also will be followed using clinical and psychological tests   "
206525|NCT00550589|"     RATIONALE: High-grade squamous intraepithelial lesions of the skin near the anus are caused     by the human papillomavirus (HPV). Antiviral drugs,, such as cidofovir, act against viruses     and may stop these lesions from becoming cancer.      PURPOSE: This phase II trial is studying the side effects and how well topical cidofovir     works in treating HIV-infected patients with high-grade squamous intraepithelial lesions of     the skin near the anus.   "
206526|NCT00550602|"     The purpose of this study is to evaluate respiratory symptoms and their impact in the quality     of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM).   "
206806|NCT00555932|"     Our overall aim is to examine if ultrasound is as accurate as MRI and/or CT in the evaluation     of dural venous sinuses. We hypothesize that sonography will be accurate (accuracy >80%) for     diagnosing specific anatomic findings of dural venous sinuses.   "
206527|NCT00550615|"     Primary Objective:        -  To determine the maximum tolerated dose (MTD) of Dasatinib in relapsed or refractory          non-hodgkin's lymphoma (NHL) patients and to determine the safety of Dasatinib in NHL.      Secondary Objectives:        -  To assess the complete and overall response rates for all Phase I and Phase II patients          and to determine overall survival and event free survival for all Phase I and Phase II          patients.        -  To assay the levels of kinase activity in NHL specimens and correlate this activity to          patient outcomes.   "
206528|NCT00550628|"     RATIONALE: Diagnostic imaging procedures, such as fludeoxyglucose F 18 PET, may be effective     in detecting cancer or recurrence of cancer, or premalignant polyps.      PURPOSE: This clinical trial is studying fludeoxyglucose F 18-PET imaging to see how well it     works in determining protein and gene expression signatures in patients with premalignant     polyps or colon cancer.   "
206529|NCT00550641|"     Pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management,     but different non-pharmacologic measures, especially physical therapies and     psychologically-based interventions, have also shown to be effective in the treatment of this     disease. The objective of the present randomized controlled trial is to compare the efficacy     and tolerability of two different modalities of active low-impact exercise in warm water:     stretching and Ai Chi. Each group of patients will receive 18 physiotherapy sessions lasting     60 minutes and will be evaluated at baseline, at treatment termination, and after 4 and 12     weeks of follow up. Main outcome measures are the Fibromyalgia Impact Questionnaire (FIQ) and     the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures include the Beck     Depression Inventory (BDI), the State and Trait Anxiety Inventory (STAI), and the SF-12     Health Survey (SF-12. Data analysis will be done using repeated measures ANOVA, unpaired     Student's t test, and effect sizes' estimation (ES).   "
206530|NCT00550654|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This phase II trial is studying how well conformal radiation therapy works in     treating patients with metastatic cancer outside the brain.   "
206531|NCT00550667|"     This study aims to establish the psychometric properties of the Adult ADHD Quality of Life     Scale (AAQoL) and to validate the diagnosis of adult ADHD by ADHD symptoms, other clinical     psychiatric symptoms, neuropsychological functioning, social/family/occupational functioning,     and intervention effect.   "
206532|NCT00550680|"     This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when     administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal     anemia. Individuals currently receiving maintenance treatment with epoetin alfa or     darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120,     200, or 360 micrograms [mcg] IV injection) derived from the dose of epoetin alfa or     darbepoetin alfa they were receiving in the week preceding study start.   "
206533|NCT00550693|"     There are currently no published data on the efficacy of the chlorhexidine-impregnated foam     dressing to reduce catheter-related bloodstream infections (BSI) in hemodialysis patients.      The researchers perfomed a cross-over intervention trial on patients who were dialyzed     through central venous catheters at two outpatient dialysis centers were enrolled. The use of     a chlorhexidine-impregnated foam dressing was incorporated into the catheter care protocol     during the intervention period. A nested cohort study of all patients who received the foam     dressing was also conducted to determine independent risk factors for development of BSI.      The primary outcomes were the catheter-related bloodstream infection rates in the     intervention and control groups. Secondary outcomes include the clinical sepsis rates between     the two groups and risk factors for development of bloodstream infection despite the use of     the foam dressing.   "
206534|NCT00550706|"     One year prospective analysis of drug utilization and prescription point prevalence of     medications in a pediatric tertiary care university medical center. Off-label use of     medications in the study population will be also registered.   "
206535|NCT00550732|"     The purpose of this study is to evaluate the efficacy and safety of posaconazole in the early     treatment of fungal infections in participants who are refractory to, intolerant to, or     medically precluded from first-line monotherapy or first-line combination antifungal therapy.   "
206536|NCT00550745|"     The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years     of age or older as required by the FDA.   "
206537|NCT00550758|"     Rational: The possible contribution of methacholine challenge test via spirometry to the     clinical diagnosis of young children with various respiratory symptoms, the most appropriate     spirometry index, and the proper cutoff point concentration that will define airway     sensitivity have not yet been explored. Objectives: To assess airway reactivity by spirometry     in a large group of children aged 3-6years with various respiratory symptoms.   "
206538|NCT00550771|"     The purpose of this study is to compare the incidence of cardiac dysfunction in subjects with     human epidermal growth factor receptor 2 (HER2) positive breast cancer treated with either     doxorubicin or pegylated liposomal doxorubicin (PLD), both in combination with trastuzumab.   "
206539|NCT00550784|"     RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of     tumor cells by stopping them from dividing or killing them. Giving colony-stimulating     factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone     marrow to the blood so they can be collected and stored. More chemotherapy is then given to     prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the     patient to replace the blood-forming cells that were destroyed by the chemotherapy.      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when     given together with cyclophosphamide, paclitaxel, melphalan, and cisplatin, followed by an     autologous peripheral stem cell transplant in treating patients with stage III, stage IV, or     recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.   "
206540|NCT00550797|"     The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and     examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness     and airway inflammation.   "
206573|NCT00551226|"     We have previoulsy shown that patients with active Tuberculosis develop a wide array of     autoantibodies including rheumatoid factor, anti-CCP, Antinuclear facyor and anti Sm     antibodies. The purpose of this study is to evaluate whether the level of autoantibodies     decrease after treatment aganist tuberculosis.   "
206541|NCT00550810|"     The major goal is to determine whether the experimental agent has clinically promising     activity that would merit progression to a formal phase III trial.      Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited     treatment options and no systemic treatment has been proven to be effective. Because of its     action, safety and simple administration SU011248 has potential for effectiveness in this     disease setting. Promising activity in this study would provide the necessary     proof-of-principle for a larger confirmatory study in this population, and potentially in     earlier stages of this common disease.   "
206542|NCT00550823|"     The diagnosis of infective endocarditis is based on the results of blood culture and findings     on transeosophageal echocardiography. Cardiac computarized tomography is a new modality,     mainly used for the imaging of coronary arteries. Its use in the diagnosis of infective     endocarditis is not well known.The purpose of this study is to establish the use of cardiac     CT in infective endocarditis.   "
206543|NCT00550836|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of     pancreatic cancer by blocking blood flow to the tumor.      PURPOSE: This randomized phase II trial is studying how well giving panitumumab together with     gemcitabine and erlotinib works compared to giving gemcitabine and erlotinib alone in     treating patients with metastatic pancreatic cancer.   "
206544|NCT00550849|"     This study assesses the safety and tolerability of RTA 402 in patients with liver disease.   "
206545|NCT00550862|"     The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels     in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to     placebo.   "
206546|NCT00550875|"     As the principal objective of this study is to evaluate the efficacy and safety of the     treatment measuring the changes in a symptom score, the patient will be asked to fill in a     patient diary. This diary will evaluate the week before the patient comes back to receive the     treatment. Nose (sneeze, blockage and running), eye (itching, redness and swelling) and chest     (breathlessness, wheeze, chest tightness), are scored on a scale from The patient will be     instructed to daily assess each one of the symptoms, recording them on an individual symptoms     follow-up diary.   "
206547|NCT00550888|"     There is no difference between extra-abdominal or in situ suture of the uterus in cesarean     section.   "
206548|NCT00550901|"     RATIONALE: Drugs used in chemotherapy, such as dexrazoxane and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may help kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of dexrazoxane when     given together with cisplatin in treating patients with advanced solid tumors.   "
206549|NCT00550914|"     The purpose of this study is to determine whether the 585-nm pulse dye laser can decrease the     time interval between surgeries and improve voice outcomes in children with severe RRP.   "
206550|NCT00550927|"     RATIONALE: Enzastaurin may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or carry cancer-killing substances to them. Enzastaurin and     bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer.     Giving enzastaurin together with bevacizumab may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin and     bevacizumab in treating patients with locally advanced or metastatic cancer.   "
206551|NCT00550940|"     This study aims to Investigate characteristics and prevalence of emotion/behavior problems in     child and adolescents with epilepsy; to identify the associated factors and their effects on     these children/adolescents; and to examine their attention by using Conners' Continuous     Performance Test (CPT).   "
206552|NCT00550953|"     The primary purpose of this study is to:      Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is     superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately     controlled with telmisartan 40 mg monotherapy.   "
206553|NCT00550966|"     This research project pretends to demonstrate that a psychoeducative program implemented in     the context of PC can produce a significant increase in the quality of life of patients with     FM, as well as a decrease in the use of sanitary and social services, compared to usual care.   "
206554|NCT00550979|"     The purpose of this research study is to look at whether there are differences in blood     vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels,     and levels of other blood markers in women who have had a pregnancy complicated by diabetes     as compared with women who have had a normal pregnancy.   "
206555|NCT00550992|"     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem     cells. When the healthy stem cells from a donor are infused into the patient they may help     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Sometimes the transplanted cells from a donor can make an immune response against the body's     normal cells. Giving cyclosporine, methotrexate, leucovorin, and antithymocyte globulin     before and after transplant may stop this from happening. It is not yet known which treatment     regimen is most effective in treating acute leukemia.      PURPOSE: This randomized clinical trial is studying how well different therapies work in     treating infants with newly diagnosed acute leukemia.   "
206556|NCT00551005|"     RATIONALE: Etoposide and celecoxib may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Giving more than 1 drug may be an effective treatment for     advanced cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when     given together with etoposide in treating patients with advanced cancer.   "
211595|NCT00621920|"     The purpose of this study is to determine the efficacious dose range when used as a bowel     preparation before colonoscopy.   "
206557|NCT00551018|"     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells     that fight infection). Previous smaller studies in HIV treatment-experienced patients, have     shown that vicriviroc is safe and effective. The purpose of this study is to evaluate the     virologic efficacy of vicriviroc combined with ritonavir-boosted Reyataz® in HIV-infected     treatment-naïve subjects.   "
206558|NCT00551031|"     The present formulations are being developed for further study in the elderly population in     order to generate additional supporting data.      Primary Objective:      To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received     either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV)     compared to that of the standard Fluzone® in elderly subjects.      Secondary Objectives:      Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone     and standard Fluzone®.      Safety:      To evaluate and describe the safety profile of investigational Fluzone in terms of solicited-     and unsolicited adverse events and serious adverse events post-vaccination.   "
206559|NCT00551044|"     The aim of this study is to comprehensively monitor the effects of a nonsteroidal     antiandrogen in patients requiring hormone manipulation for prostate cancer   "
206560|NCT00551057|"     The purpose of this trial is to investigate the expression of different inflammatory proteins     in cancer and normal pancreatic tissue.   "
206561|NCT00551070|"     This phase II trial is studying the side effects and how well selumetinib works in treating     patients with recurrent low-grade ovarian cancer. Selumetinib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
206562|NCT00551083|"     The purpose of this study was designed to test the feasibility and effectiveness of     implementing a Computerized Decision Support System for depression (CDSS-D) during acute care     in a primary care setting.   "
206563|NCT00551096|"     Zactima will be used in this study to determine the highest dose that can be given safely as     well as the side effects of Zactima when in combination with two FDA approved drugs;     gemcitabine and capecitabine. This combination will be given to patients with advanced solid     tumors. Once the highest dose of the combination has been determined, additional patients     with biliary cancers (cholangiocarcinomas and gallbladder cancer) and locally advanced or     metastatic pancreatic cancer will be treated at the highest determined dose for further     studies.   "
206564|NCT00551109|"     The purpose of this study is to determine the efficacy of SA4503 compared to placebo in the     treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety     of SA4503 compared to placebo in subjects with MDD.   "
206565|NCT00551122|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, ifosfamide, and     cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or     die. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when     given together with paclitaxel, ifosfamide, and cisplatin, and to see how well they work in     treating patients with progressive or relapsed metastatic germ cell tumors.   "
206566|NCT00551135|"     The purpose of this study is to test whether pregabalin added to the standard of care with     dosing starting preoperatively and continuing for 1 week post surgery will decrease the     intensity of acute post-operative pain following inguinal hernia repair.   "
206567|NCT00551148|"     The purpose of this study is to further explore an effective dose range of PD0200390 for the     treatment of patients with insomnia.   "
206568|NCT00551161|"     We are studying subjects with mild to moderate Alzheimer's disease who have been on a stable     dose of any cholinesterase inhibitor [donepezil (Aricept), rivastigmine (Exelon), or     galantamine (Razadyne)] for at least 3 months, and have not previously taken memantine     (Namenda). This is an open-label study, with magnetic resonance spectroscopy (MRS) as the     primary outcome measure, along with neuropsychological testing, and optional lumbar puncture,     evaluating patients on their stable dose of a cholinesterase inhibitor over 24 weeks,     followed by another 24 weeks on memantine in combination with stable dose of cholinesterase     inhibitor. The purpose of this study is to characterize the progression of disease using MRS,     cerebrospinal fluid (CSF) biomarkers, and cognitive outcome measures, and to determine     whether changes in cognitive function on neuropsychological testing are correlated to changes     in MR spectroscopic and/or CSF biomarkers.   "
206569|NCT00551174|"     This 2-arm study was designed to assess the long-term safety and tolerability of intravenous     (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had     previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received     Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received     daily supplementation with vitamin D and calcium. The anticipated time on study treatment was     2+ years, and the target sample size was 500+ individuals.   "
206570|NCT00551187|"     The purpose of this study is to evaluate vaccine immunogenicity and how well the body     tolerates V504 when given with Gardasil.   "
206571|NCT00551200|"     The purpose of this study is to determine whether HPN-100 is safe and tolerable in subjects     with Urea Cycle Disorders.   "
206572|NCT00551213|"     The purpose of this study was to determine the activity of two doses of robatumumab (SCH     717454, MK-7454) in participants with relapsed or recurrent colorectal cancer.      The primary study hypothesis was that decreases in Positron Emission Tomography     (PET)-assessed tumor glucose metabolism (i.e., fluorodeoxyglucose [FDG] standardized uptake     value [SUV]) following administration of 10 mg/kg robatumumab will exceed those following     administration of 0.3 mg/kg robatumumab in participants with relapsed or recurrent colorectal     cancer who had progressed after first-line chemotherapy.      Investigator choices of standard chemotherapy: irinotecan as a single agent +/- cetuximab OR     capecitabine as a single agent, OR FOLFOX (leucovorin calcium [folinic acid][FOL] +     fluorouracil [F] + oxaliplatin [OX]) OR CAPEO(capecitabine [CAPE] or Xeloda® [XEL] +     oxaliplatin [OX]) OR FOLFIRI (leucovorin calcium [folinic acid][FOL] + fluorouracil [F] +     irinotecan [IRI]) +/- cetuximab OR cetuximab as a single agent.   "
206639|NCT00553696|"     To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered     in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer.   "
206574|NCT00551239|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and pixantrone, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. It is not yet known whether giving     fludarabine together with rituximab is more effective with or without pixantrone in treating     indolent non-Hodgkin lymphoma.      PURPOSE: This randomized phase III trial is studying fludarabine and rituximab to compare how     well they work with or without pixantrone in treating patients with relapsed or refractory     indolent non-Hodgkin lymphoma.   "
206575|NCT00551252|"     The purpose of this study is to evaluate the antitumor activity of a combination of Imatinib     mesylate and Gemcitabine in patients with unresectable malignant mesothelioma expressing     either PDGFR-beta or C-kit   "
206576|NCT00551265|"     This randomized clinical trial is studying the side effects of oregovomab and to see how well     it works with or without cyclophosphamide in treating patients with stage III or stage IV     ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that responded     to second-line chemotherapy. Monoclonal antibodies, such as oregovomab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. It is not yet known     whether oregovomab is more effective when given together with or without cyclophosphamide in     treating patients with stage III or stage IV ovarian epithelial cancer, fallopian tube     cancer, or primary peritoneal cancer.   "
206577|NCT00551278|"     The purpose of this trial is to show adequate assay performance on clinical samples tested in     real time at the clinical site.   "
206578|NCT00551291|"     This single arm study will evaluate the efficacy and safety of a combination of NeoRecormon,     CellCept and prednisone in patients with low or moderate risk myelodysplastic syndromes     (MDS). In the first phase of the study, patients will receive CellCept (1g p.o. twice daily)     plus prednisone. After 3 months, if patients have not responded to treatment, NeoRecormon     (30000 IU/week, s.c.) will be added to the treatment regimen. If there is no response to     NeoRecormon after 6 weeks, the dose will be increased to 60000 IU/week. The anticipated time     on study treatment is 3-12 months, and the target sample size is <100 individuals.   "
206579|NCT00551304|"     To investigate the utility of renal denervation in the treatment of patients with End Stage     Renal Disease (ESRD).   "
206580|NCT00551317|"     This study is being conducted to provide initial safety, tolerability, PK and PD data that     will allow further studies with darapladib in Japanese patients   "
206581|NCT00551330|"     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells     that fight infection). Previous smaller studies in HIV treatment-experienced patients, have     shown that vicriviroc is safe and effective. The purpose of this study is to investigate in     subjects with detectable dual/mixed CCR5/CXCR4-tropic HIV whether vicriviroc when added to     other appropriate HIV drugs can decrease the level of HIV (viral load) in the blood and that     it is well tolerated.      This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study of     vicriviroc maleate in HIV subjects infected with dual/mixed CCR5/CXCR4-tropic virus and who     have documented resistance to at least 2 of the 3 antiretroviral drug classes (NRTI, NNRTI or     PI) or at least 6 months experience with at least 2 of the following: one NRTI, one NNRTI, or     one PI (excluding low-dose ritonavir) and failure on their current stable regimen. The study     will compare the virologic benefit of adding vicriviroc to an optimized background regimen to     a control group receiving placebo plus the new optimized background therapy. The optimized     background regimen will be chosen by the investigator based on results of drug susceptibility     tests performed at Screening, history of prior antiretroviral drug use by the patient, and     drug toxicity. Primary efficacy analysis will be conducted when all subjects have completed     48 weeks of treatment. An interim analysis will be performed when all subjects have completed     24 weeks of treatment. Subjects who complete 48 weeks of treatment, or who discontinue early     but are deemed eligible upon rescreening, will be offered participation in the open-label     segment of the study, and will receive vicriviroc 30 mg once daily, if appropriate, until     commercially available or until the sponsor terminates the clinical development of     vicriviroc.   "
206582|NCT00551343|"     The purpose of this study is to investigate the effects of a GLP-1 agonist on satiety     hormones in patients with Prader-Willi Syndrome (genetic defect causing obesity).   "
206583|NCT00551356|"     In patients with type 2 diabetes who have not been on insulin therapy before the study will     achieve better glycemic control by the treatment regiment consisting of two times daily     insulin lispro mix 25 than by the treatment regiment with consisting of one time daily     injection of insulin glargine. Improved glycemic control will be compared by the fasting     plasma glucose and blood glucose excursions 2 hours after breakfast.   "
206584|NCT00551369|"     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the     tumor and cause less damage to normal tissue near the tumor.      PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works     in treating patients with stage I or stage II non-small cell lung cancer that can be removed     by surgery.   "
206585|NCT00551382|"     Viral upper respiratory tract infection (URI) is one of the most common diseases among     toddlers and pre-school children.Complete and effective prevention measures for URI are     currently unavailable.      Montelukast (Singulair ) is a selective leukotriene-receptor antagonist that inhibits the     cysteinyl leukotriene 1 receptor. It is well tolerated and safe even in young children.     Montelukast is an effective treatment for asthma (and allergic rhinitis from 1 year of age.     Infections with viruses causing URI such as Influenza A, Rhinovirus and respiratory syncitial     virus increases leukotriens levels in nasal secretions. Therefore, one may postulate that     leukotriens inhibitors may reduce symptoms during URI. However the effect of montelukast as a     treatment for non-specific cough was not properly studied and there are no studies on the     effect of montelukast as prevention for URI.      Hypothesis: Prophylactic treatment with Montelukast will reduce the incidence and severity of     upper respiratory infection in children.   "
206586|NCT00551395|"     This study will evaluate the effect of the timing of treatment completion in two-staged     selective laser trabeculoplasty therapy on intraocular pressure lowering effect.   "
206640|NCT00553709|"     The purpose of this study is to determine whether nicotine is effective in the prevention of     nausea and vomiting in non-smokers undergoing surgery   "
206982|NCT00561106|"     Since steroids carry a moderate beneficial effect in Bell's palsy, and to address this     question, valacyclovir was added to prednisone for the treatment of this condition.   "
206587|NCT00551408|"     Endothelial dysfunction ultimately represents an imbalance between the magnitude of injury     and the capacity for repair.      Current evidence established that endothelial progenitor cells (EPC) participate in several     models of vascular disease as acute coronary syndromes, stroke, diabetes, peripheral artery     disease, etc. However EPC in the setting of PAH is less well established. The target of this     study is to demonstrate if the number of EPC is increased in a mexican population of patients     with PAH.   "
206588|NCT00551421|"     Monoclonal antibodies, such as pertuzumab and cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Giving pertuzumab together with     cetuximab may kill more tumor cells. This phase I/II trial is studying the side effects and     best dose of pertuzumab when given together with cetuximab and to see how well they work in     treating patients with previously treated locally advanced or metastatic colorectal cancer   "
206589|NCT00551434|"     The study is a double blind 2x2 factorial study. Patients with coronary disease will be     randomly be assigned to L-arginine (9 g/day), creatine 21 g/d, both, or neither dietary     supplement. The function of the endothelium will be tested using ultrasound before and after     each treatment. These studies will help us understand why the endothelium is abnormal in     patients with coronary artery disease and how L-arginine is acting on endothelial function.   "
206590|NCT00551447|"     This purpose of this study is to determine if the administration of ezetimibe and simvastatin     together is more effective than simvastatin alone in lowering LDL-C levels to a goal of <100     mg/dL in patients at risk for Heart Disease.   "
206591|NCT00551460|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and     help kill them or carry cancer-killing substances to them. Others interfere with the ability     of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic     leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination     chemotherapy may be more effective in treating promyelocytic leukemia.      PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination     chemotherapy works in treating patients with previously untreated promyelocytic leukemia.   "
206592|NCT00551473|"     Current treatment for gastroesophageal reflux disease(GERD)confirms an unmet need in     patients, based on slow onset of action and an inability to provide 24-hour gastric acid     suppression. Clinical data on lavoltidine demonstrates a rapid onset of action, high potency,     and prolonged duration of effect after single dose. Since tolerance to the class of compounds     to which lavoltidine belongs may be dose dependent, the current study is designed to     determine if 40mg lavoltdine given for 7days develops tolerance.   "
206593|NCT00551486|"     To investigate the diagnostic efficiency of pyrosequencing for the mutant BRAF allele in     ultrasound (US)-guided fine needle aspiration biopsies (FNAB) of thyroid incidentalomas.   "
206594|NCT00551499|"     The primary objective of this study is to compare the Apnea- Hypopnea Index in HF patients     with concomitant CSA, after 12 weeks of CRT alone to CRT in combination with one night of     overdrive pacing. Secondary objectives are to evaluate the effects of a single night of     overdrive pacing applied after 12 weeks of CRT vs. CRT alone on breathing events, sleeping     events, and neurohormonal markers. An additional secondary objective of the study is to     compare the efficacy of CRT in HF patients with concomitant CSA to HF patients without     concomitant CSA.   "
206595|NCT00551512|"     The purpose of this research study is to find the answers to the following questions:        1. What are the highest doses of CBP501 and cisplatin that can be safely administered as          consecutive 2-hours and 1-hour infusions every 21 days?        2. What are the side effects of the combination of CBP501 and cisplatin when given as an          infusion every 21 days?        3. What amount of CBP501 and cisplatin are found in the blood at certain times after it is          given?        4. Are there any substances in your blood or tumor that can tell us about tumor sensitivity          to CBP501 and cisplatin?        5. Will CBP501 given with cisplatin help to treat your cancer?   "
206596|NCT00551525|"     RATIONALE: Giving samarium Sm 153 lexidronam pentasodium and 3-dimensional (3-D) conformal     radiation therapy or intensity-modulated radiation therapy may keep prostate cancer from     growing in patients with rising prostate-specific antigen (PSA) levels after radical     prostatectomy for prostate cancer.      PURPOSE: This phase II trial is studying how well samarium Sm 153 lexidronam pentasodium and     3-D conformal radiation therapy or intensity-modulated radiation therapy work in treating     patients with rising PSA levels after radical prostatectomy for prostate cancer.   "
206597|NCT00551538|"     The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will     result in lower post prandial blood glucose readings versus once-daily glargine plus oral     diabetic medications.   "
206598|NCT00551551|"     Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital     prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of     women with prenatal pelvic floor exercises and a control group.      Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.   "
206599|NCT00551564|"     Insulin resistance (IR) is common in many metabolic disorders and predisposes an individual     to Type 2 Diabetes Mellitus (T2DM), the Metabolic Syndrome and coronary atherosclerosis.     Non-diabetics with IR are at risk, but can be difficult to diagnose.      A major problem with the use of IR as a predictor or marker of disease is the lack of a     simple, robust test that can be used to quantify this parameter in a wide variety of clinical     situations. The current 'gold standard' methods for measuring insulin sensitivity, such as     the hyperinsulinemic-euglycemic (H-E) clamp, are complex, time consuming and costly.     Alternative, simpler methods, such as the Homeostasis Model Assessment (HOMA-IR) score, may     be less accurate and are not widely accepted.   "
206600|NCT00551577|"     The purpose of this study is to evaluate response to neoadjuvant chemotherapy by imaging and     observation of anatomical and biological indicators (i.e. ascites or continuous measurement     of tumor marker CA 125). Furthermore the optimal number of preoperative administered cycles     of combination chemotherapy with carboplatin and docetaxel should be determined.   "
206601|NCT00551590|"     The purpose of this study is to assess the effect of the DPP-4 inhibitor sitagliptin on the     incretin effect in patients with type 2 diabetes mellitus.   "
206602|NCT00551603|"     Several recent reports support the efficacy of once every-other-week epoetinum administration     in the maintenance phase of the anaemia treatment in predialysis, haemodialysis and in     peritoneal dialysis CKD patients.      However, there are studies suggesting that in HD patients receiving SC short-acting ESA     therapy, ESA efficacy decreases when the dosing is extended from thrice-weekly to once-weekly     administration. When every-2-week administration of long-acting ESAs is extended to every 4     weeks, efficacy either remains stable or decreases incrementally. The GAIN trial (Gain     effectiveness in Anemia treatment with NeoRecormon®) was designed to compare anemia     management with epoetin beta, epoetin alpha or darbepoetin alpha in HD patients. An interim     analysis of data from 1005 stable HD patients suggested that switching to epoetin beta from     either epoetin alpha or darbepoetin alpha resulted in improved efficacy and a 20% dose     reduction in SC epoetin beta.      The aim of the study is to compare two schedules of anaemia treatment in HD patients using     two different erythropoietic stimulating agents (epoetinum beta vs darbepoetinum) with     respect to the efficacy in anaemia correction and to the haemoglobin (Hb) level stability.      This is a multicenter (2 centers), prospective, open-label, parallel, controlled trial of     therapy equivalence   "
206603|NCT00551616|"     The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to     levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.   "
206604|NCT00546026|"     Women whose pregnancies are at judged to be at risk of a poor outcome from an early delivery     due to medical problems such as diabetes or high blood pressure, are often very anxious     during pregnancy, at least until they know they have passed the risk period of premature     birth (after 8 months). Anxiety itself can have a significant effect on the developing baby,     on the newborn child and the mother-infant bonding process. We will use a combination of     pregnancy blood tests and an ultrasound assessment to check on placental function, since     placental damage is the greatest cause of poor outcome. Most women tested this way will have     normal results, and so may feel reassured and do better in pregnancy than untested women. The     benefits may extend after birth to mother-infant bonding, breastfeeding success and a reduced     risk of postnatal depression. We will randomly select an equal number of women for testing     and no testing (like tossing a coin, known as a randomized control trial) to be confident     that any benefits observed are genuine. The potential benefits of our research would be     substantial for the mental health of many pregnant women, for their newborn and for their     children as they grow up. The tests are easy to do and would add very little in terms of a     woman's and in terms of the total costs of prenatal care.   "
206605|NCT00546039|"     The purpose of this study is to evaluate safety and mechanisms of possible chemopreventive     effects of synthetic genistein (BONISTEIN™) in patients with localized prostate cancer     undergoing laparoscopic radical prostatectomy.   "
206606|NCT00546052|"     To determine if a one year treatment Losartan with or without HCTZ at different dosages have     an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.   "
206607|NCT00551629|"     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 4     different formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate,     recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular     pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at     least 1 of the 4 formulations of HR5I administered as a primary series at 2, 3, and 4 months     of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody     responses to all antigens.   "
206608|NCT00551642|"     The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to     reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to     assess the long-term effects of the therapy on the development of these children over 7 years     of clinical follow-up.   "
206609|NCT00551655|"     Tenofovir (TDF)-containing regimens may be associated with decreasing renal function in     HIV-infected patients concurrently treated with boosted PI's and/or have co-morbid conditions     including diabetes mellitus, hypertension, anemia, hepatitis B, and hepatitis C.   "
206610|NCT00551668|"     The objective of this prospective, randomized cohort study was to evaluate the clinical     results between operative and nonoperative treatment of primary patellar dislocation.   "
206611|NCT00551681|"     To compare a surgical approach of LV lead placement for BIV pacing with the conventional     transvenous approach by assessment of differences on the effects on cardiac perfusion and     relate this to the clinical cardiac function.   "
206612|NCT00551694|"     The purpose of this study is to compare the effects of single and repeat doses of GSK256073     with placebo in HVT subjects that have been administrated GSK256073 in the HMA107787 study   "
206613|NCT00551707|"     CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug     dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to     work through a novel mechanism of action in which dipyridamole selectively amplifies the     anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating     the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in     proof of concept studies in subjects with hand Osteoarthritis (OA) and Rheumatoid Arthritis     (RA).      In this trial, CRx-102 will be given to subjects with active RA as an add-on therapy to     existing stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs) including     methotrexate (MTX), sulfasalazine, hydroxychloroquine, leflunomide or azathioprine. MTX in     combination with other DMARDs (e.g., sulfasalazine or hydroxychloroquine) will be permitted     to reflect the current standard of care practices within rheumatology.   "
206614|NCT00551720|"     The purpose of this study is to develop and evaluate a brief, clinic-based smoking cessation     treatment for an HIV+ population. We compared two treatments, a brief advice and follow-up     plus nicotine patch treatment(Standard Care; SC) and brief advice and follow-up, nicotine     patch, with the addition of a tailored motivational intervention and behavioral skills     counseling for smoking cessation (Motivationally-Enhanced; ME), in a randomized controlled     trial. We hypothesized that those HIV+ participants receiving the ME will demonstrate greater     biochemically verified smoking abstinence rates at 6-month follow-up than those receiving the     SC control treatment. All study participants were offered use of the nicotine patch.   "
207037|NCT00561834|"     The purpose of this study is to explore the safety and efficacy of ranibizumab to treat     non-arteritic ischemic optic neuropathy based on clinical and anatomical findings.   "
206615|NCT00551733|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, and paclitaxel     poliglumex, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. It is not yet known whether giving carboplatin     together with paclitaxel poliglumex is more effective than giving carboplatin together with     paclitaxel in treating non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel poliglumex to     see how well they work compared with carboplatin and paclitaxel in treating women with stage     III, stage IV, or recurrent non-small cell lung cancer.   "
206616|NCT00551746|"     Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the     Western world and is associated with high-calorie diet, high body mass, and a variety of     other factors. CHD can lead to myocardial infarction (MI) and other embolic events. In some     areas such as France, though, a paradox of high-cholesterol diets but low CHD and MI     incidence have been found. This paradox has been traced to the consumption of red wine.     Further research suggests that components of the grapes used in red wine may be the source of     the cardio-protective factors that have resulted in the French paradox. These components are     also present in purple grape juice (PGJ). PGJ has been shown to have a variety of potential     cardio-protective effects, including inhibition of platelet aggregation. Since PGJ does not     contain alcohol it may provide an additional benefit by avoiding the physical and social     implications of alcohol abuse. Since most of the research of PGJ has been in vitro, though,     and the few studies in vivo have been in cross-over studies and over very short durations of     7 to 14 days, additional research is required to determine whether the long-term consumption     of PGJ is of additional and sustained benefit, similar to long-term use of red wine in     France. The proposed study is a 2 arm randomized, controlled (double-blind) study of PGJ and     a calorically-matching placebo drink in 100 healthy individuals.   "
206617|NCT00551759|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and docetaxel, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Giving these treatments before surgery may     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.     Giving docetaxel and cetuximab after surgery may kill any tumor cells that remain after     surgery.      PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy     together with cetuximab followed by surgery, docetaxel and cetuximab works in treating     patients with esophageal cancer or gastroesophageal junction cancer.   "
206618|NCT00551772|"     SB-742457 is a 5HT6 receptor antagonist that is in development for the symptomatic treatment     of mild to moderate Alzheimer's disease . To date, all clinical trials have been conducted     using a capsule formulation of SB-742457. However, it is intended to conduct all futures     studies with a tablet formulation. The aim of this study is to assess the pharmacokinetic     profile of SB-742457 and its major metabolites following single doses of both the capsule and     tablet formulations.   "
206619|NCT00551785|"     The primary objective of the study is to assess the risks of testosterone transdermal patch     use in a representative study population. The primary clinical outcome of interest is breast     cancer.   "
206620|NCT00551798|"     Predicting response to chemotherapy in patients with Hodgkin's disease or lymphoma high-grade     malignant de novo or recurrence.      The non-Hodgkin's lymphoma and high-grade Hodgkin's disease may show resistance to     chemotherapy, regardless of their initial extension. The failure of treatment is most often     correlated with an incomplete answer or lack of response to chemotherapy as a result     chemoresistance. This drug, which may involve the gene MDR1 (multidrug resistance) encoding     the protein PGP, can be studied in vivo by MIBI scan. The MIBI is behind a tracer     perfusionnel used routinely to explore myocardial perfusion, but it has other characteristics     of fixing, which can be used in oncological imaging (fixation by glial tumors of high     grade).Prospective Study, which includes conducting a tomoscintigraphie 30 minutes after     injection of 20 mCi of 99mTc-MIBI in initial stock or relapse of high-grade lymphoma and     Hodgkin's disease any stage (I-IV). Fixing the MIBI is compared with morphological     abnormalities detected by CT and the setting of lesions by 18FDG. Patients will be treated in     a traditional way, without changes in treatment protocols used in routine. Patients with a     negative MIBI scan, will be watched with particular attention in order to detect insufficient     response to chemotherapy. The only change, the care of patients, only for the achievement of     an initial consideration of non-invasive imaging, further, which is the tomoscintigraphie the     MIBI. Of the tumor samples, will be evaluated by immunohistochemistry, the expression of PGP     and the MRP1 (two proteins associated with the drug). On blood, may be carried out genotyping     of MDR1, MRP1 and MRP2 to the patient.   "
206621|NCT00551811|"     A study to evaluate the effect of SB-656933-AAA on the body after a single dose in subjects     who have been challenged with ozone.   "
206622|NCT00551824|"     This study aims to evaluate mitomycin C as an adjunct to endoscopic treatment of esophageal     strictures.      This is a crossover, controlled, clinical trial in which children with esophageal stricture     will be randomized in two groups to receive either topical mitomycin or no additional     treatment during standard esophageal dilation session.   "
206623|NCT00551837|"     The purpose of this study is to evaluate the immune response to a routine influenza     vaccination. Influenza vaccination is given as part of routine standard of care in these     individuals and is not part of the study protocol. The study will evaluate for a change in     response to common antigens over time after influenza vaccination to determine if changes are     related to the development of chronic rejection after solid-organ transplantation. We     hypothesize that the influenza vaccine contributes to the alloreactivity of T cells verses     common HLA types in the donor pool.   "
206653|NCT00553891|"     This is a randomized, double-blind, placebo-controlled study to document the long-term effect     of treatment with mometasone furoate nasal spray in moderate to severe adenoids hypertrophy     as reflected by the need for removal of the adenoids within one year of the treatment     regimen. Subjects will be assigned treated with either mometasone furoate nasal spray or     placebo for 3 months. Subjects will be followed for an addition 12 months. Serious AEs will     be followed starting first dose-till 30 days after study treatment period completion.      This study was terminated - Please see P04367 - Lebanon   "
206624|NCT00551850|"     The Epidermal Growth Factor Receptor (EGFR) is a validated target for the treatment of     cancer, and agents targeting EGFR such as erlotinib (Tarceva®) are approved by the FDA for     treatment of various solid tumors. AV-412 is a novel inhibitor of the EGFR-tyrosine kinase,     with added activity against Her2 and other oncogenic kinases. Based on evidence of     preclinical activity in various solid tumors, AV-412 is being developed as a possible novel     treatment for cancer in humans.      PURPOSE: The purpose of this study is to test the safety and tolerability of AV-412, and     determine the maximum tolerated dose of AV-412 when administered orally three times weekly.   "
206625|NCT00551863|"     The purpose of this project is to develop and pilot test a violence prevention intervention     for men and women in treatment for substance use problems.   "
206626|NCT00551876|"     The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing     20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the     dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).   "
206627|NCT00551889|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Celecoxib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Giving cyclophosphamide together with celecoxib may help kill more     cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when     given together with cyclophosphamide in treating patients with advanced cancer.   "
206628|NCT00551902|"     In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye     and allows for the lowering of the pressure inside the eye. The flow through the surgically     created fistula determines the intraocular pressure. Titrating suture tightness is important     to achieving the desired post-operative intraocular pressure. This process is not     straightforward and intraocular pressures are often too high or too low post-operatively.   "
206629|NCT00551915|"     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3     formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant     hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and     inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 3     formulations of HR5I administered as a primary series at 2, 4, and 6 months of age will be     acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all     antigens.   "
206630|NCT00551928|"     To compare the efficacy of the combination of lenalidomide with low-dose melphalan versus     high-dose melphalan in newly diagnosed, symptomatic MM patients.   "
206631|NCT00551941|"     The researchers propose a prospective, randomised partially-blinded study to investigate the     clinical and radiological outcome, effect on quality of life and socio-economic impact of     non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen     allograft, in comparison to treatment with allograft together with DBM (demineralised bone     matrix).   "
206632|NCT00551954|"     Endothelial dysfunction (ED) has been suggested as a possible causal link between     postprandial hyperglycemia and cardiovascular events in patients with type 2 diabetes. Recent     trials demonstrated a reduction of cardiovascular events by treatment with the alpha     glucosidase inhibitor acarbose - a drug which mainly reduces postprandial glucose excursions.     We were interested whether patients with newly diagnosed type 2 diabetes showed postprandial     ED and if so whether acarbose was able to improve this condition.   "
206633|NCT00553618|"     The purpose of this study is to see if the combination of the two cancer drugs, Dacarbazine     (DTIC) and a low-dose of Proleukin (IL2), would provide a less toxic and more effective     treatment for melanoma than currently available treatments for people with high-risk     melanoma. Dacarbazine (DTIC) and Proleukin (IL2) are both FDA-approved drugs for the     treatment of melanoma.   "
206634|NCT00553631|"     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme     glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside     accumulates within macrophages leading to cellular engorgement, organomegaly, and organ     system dysfunction. The purpose of this non-inferiority study is to evaluate the efficacy and     safety of GA-GCB (velaglucerase alfa) administered every other week in comparison to     imiglucerase in treatment naive patients with type 1 Gaucher disease.   "
206635|NCT00553644|"     This phase II trial studies how well bortezomib and lenalidomide work in treating patients     with mantle cell lymphoma that has come back after a period of improvement (refractory) or is     not responding to treatment (refractory). Bortezomib may also stop the growth of cancer cells     by blocking some proteins needed for cell growth. Lenalidomide may stimulate the immune     system to kill cancer cells and may also block the growth of new blood vessels necessary for     cell growth. Giving bortezomib with lenalidomide may be an effective treatment for relapsed     or refractory mantle cell lymphoma.   "
206636|NCT00553657|"     The purpose of this study is to determine if standardizing fluid intake in a clinic setting     will reduce variability of individual voiding parameters and potentially serve as a way to     limit patient exposure in the initial assessment of efficacy of compounds being developed for     Overactive Bladder.   "
206637|NCT00553670|"     Coronary artery bifurcation lesion is still one of the most challenging lesion subsets in the     field of non-surgical treatment for a stenotic coronary artery. When one stent is placed in     the main brach, it increases the side branch's stenosis degree. However, its mechanism and     incidence are not known. This study will be performed to search for the mechanism and     incidence of that phenomenon.   "
206638|NCT00553683|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill     tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Poly ICLC may     stop the growth of liver cancer by blocking blood flow to the tumor. Giving the drug directly     into the arteries around the tumor may kill more tumor cells. Giving cyclophosphamide and     radiation therapy together with poly ICLC may be an effective treatment for liver cancer.      PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide,     radiation therapy, and poly ICLC together and to see how well they work in treating patients     with unresectable, recurrent, primary, or metastatic liver cancer.   "
206641|NCT00553722|"     It is well known that Aldosterone (aldo) can cause hypertension (HBP). Since aldo is known to     cause the kidney to retain sodium (Na) and Na retention is known to cause HBP, it has been     thought that the mechanism by which aldo causes HBP is by Na retention. Recent studies have     suggested that aldo has many effects in addition to its ability to cause the kidney to retain     Na. To test the hypothesis that aldo can cause HBP in a manner which does not involve Na     retention, we plan, in this protocol, to give Eplerenone, a specific aldo antagonist, to     patients on dialysis who have HBP. A positive effect of Eplerenone to lower HBP in these     patients would support this hypothesis.   "
206642|NCT00553735|"     The purpose of this study is to determine whether Restasis is an effective treatment for     preventing the occurrence and progression of dry eye syndrome in patients who have recently     received a bone marrow transplant and are at risk to graft-versus-host disease.   "
206643|NCT00553748|"     This is a ten subject, phase 1 study. The purpose of the Phase 1 study is to demonstrate drug     safety in a target group of subjects with high grade brain cancer. This population represents     a potential clinical population that may benefit from this PET imaging tracer. The study will     also begin collection of baseline imaging data and allow us to gain information to improve     design and conduct of future trials.   "
206644|NCT00553761|"     The study is designed to evaluate the ability of pattern electroretinogram (PERG) and     multifocal pattern electroretinogram (mfPERG) to measure and identify the pattern of band     atrophy of the optic nerve in patients with long standing chiasmal lesions. The hypothesis is     that these electrophysiological tests were able to identify this such pattern. The idea is to     investigate the ability of the these electrophysiological technics in detecting the neural     loss from chiasmal compression and to evaluate the ability of PERG and mfPERG parameters to     differentiate between eyes with band atrophy of the optic nerve and healthy eyes.   "
206645|NCT00553774|"     Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular     events in patients with coronary artery disease (CAD). CAD patients also show impaired     function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate     in adult blood and contribute to endothelial repair. Clinical studies suggest that     endothelial function can be improved in CAD patients by consumption of flavanol-rich cocoa.     Yet, the mechanism is not known. It is also not known whether flavanol-rich cocoa provides an     additive, positive effect in patients who are already receiving the maximal recommended     therapies for risk factor modification. Therefore, the researchers propose to perform an     investigator-initiated, randomized controlled cross-over study administering flavanol-rich     cocoa or a placebo for two months in CAD patients on optimal medical therapy. An improvement     of endothelial function as measured by flow-mediated dilation (FMD) will be the primary     endpoint of this study. The researchers propose to also measure determinants of FMD such as     microvascular response, inflammatory markers, metabolites of nitric oxide, as well as the     number and function of EPCs in the blood. Importantly, detailed food questionnaires and     plasma flavanols/metabolites will help to further support a causal link between     flavanol-intake and improved vascular function.   "
206646|NCT00553787|"     The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to     placebo in treatment of obesity in an adult population with obesity related co-morbid     conditions.   "
206647|NCT00553800|"     This study will evaluate the combination of bevacizumab and erlotinib in elderly patients     with advanced non-small cell lung cancer.   "
206648|NCT00553813|"     The primary objective of the study is to assess the activity of TPI 287 as single agent     therapy for patients with advanced, unresectable pancreatic cancer after failure of     gemcitabine-containing therapy. Activity of TPI 287 will be determined by the 6-month     survival rate.   "
206649|NCT00553839|"     Dosing of medications is based on the plasma level achieved with a given dose and how long     the medicine remains in the body. This study is called pharmacokinetics-that is, what the     body does to the medication. Ketamine is an intravenous medication used for anesthesia and     sedation in children. However the pharmacokinetics of Ketamine has not been systematically     studied. We propose to study the pharmacokinetics of ketamine in different age groups of     children ranging from infants to teenagers.   "
206650|NCT00553852|"     Obesity and obesity-related diseases have reached epidemic proportions in Western countries     (1-3). Laparoscopic-adjustable silicone gastric banding (LASGB) is a purely restrictive     operation that determine effective weight loss without inducing malabsorption (4-6). However,     also after LASGB body weight loss is almost invariably associated with Free Fat Mass (FFM)     loss, and the relevance of the FFM contribution to total energy expenditure is well-known     (7-8). Different endocrine axes are reported to affect FFM. We previously reported that low     levels of DHEA-S, an adrenal steroid with controversial anti-adipogenic and anti-atherogenic     effects, are increased after the massive and sustainable weight loss induced by LASGB in     severely obese premenopausal women and correlated with the higher post-operative FFM (9-10).     It is also well known that GH/IGF-I axis exerts relevant effects on FFM and that reduced GH     levels might increase Fat Mass (FM) and reduce FFM (11,12). Morbidly obese patients have a     reduced GH secretion, generally reversible after weight loss (13-14). In a recent study     currently in press, we reported that a persistent deficiency in the GH/IGF-I axis in very     obese females is associated to lower decrease in FM after LASGB. Low IGF-I plasma levels have     also been reported to be independent prognostic factors of liver steatosis and non-alcoholic     steatohepatitis in morbidly obese patients (15) and ultrasound- measured hepatic left lobe     volume might represent a reliable tool for the evaluation of liver involvement in obesity     (16). GH deficiency (GHD) in adult patients is associated with an increase in FM and a     parallel decrease in FFM (17). The severity of GDH is correlated to cardiovascular risk, body     composition abnormalities and bone loss, and decreased left ventricular ejection fraction     (18-20). GH therapy has been demonstrated to be effective in normalizing body composition,     with beneficial effects up to a 2-years follow-up period (21-24). GH therapy has also been     reported to be effective in sparing FFM during weight loss in obese patients and metabolic     syndrome (25,26). However, these studies have some limitations due to the duration of the     treatment and the lack of a preliminary evaluation of the GH/IGF-I axis secretory status in     obese patients before the GH therapy. At present there are no data on the evaluation of the     GH/IGF-I status before and after bariatric surgery and the effectiveness of recombinant GH     treatment in very severe obese patients.   "
206651|NCT00553865|"     The purpose of this study is to determine the optimal dosage of the clinical trial which is     evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with     the uncomplicated essential hypertension.   "
206652|NCT00553878|"     Patient on an intermittent androgen deprivation protocol for biochemical recurrence after     radical local therapy for prostate cancer,the addition of continuous dutasteride treatment,     significantly prolongs the duration of the off treatment interval and time to androgen     independence.   "
206691|NCT00554398|"     An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART     regimen with persistent HIV-1 viral suppression could increase the slope of decay of the     HIV-1 latent reservoir.   "
241897|NCT01010321|"     The investigators speculate that this tool may be used as an alternative and convenient     non-invasive diagnostic of skin cancer.   "
206654|NCT00553904|"     A pilot study of 15 subjects will be completed to determine whether acute consumption of     cranberry juice has an effect on endothelial function. We will then complete a randomized,     double blind, placebo controlled crossover study designed to investigate the effects of     cranberry juice consumption on endothelial function. Participants (n=40) will drink 480 ml of     double strength cranberry juice or a similar appearing and tasting placebo per day for four     weeks. After a two week rest period, they will cross over to the other beverage. We will     examine endothelial function before and after each of the two treatment periods. The study     will provide information about the chronic vascular effects of cranberry juice.   "
206655|NCT00553917|"     The purpose of this study is to evaluate if during pregnancy, a common group of     antidepressant medications (SSRI's) adequately treats the symptoms of depression and to     evaluate if there are any effects of these medications on the newborn infant.   "
206656|NCT00553930|"     Hypothesis: A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective     as currently recommended regimen for chronic hepatitis C in HIV-coinfected patients.      Objective: To evaluate the efficacy of lower dose of pegylated interferon-α 2a (135 µg     weekly) plus ribavirin and a shorter duration of treatment (20 weeks after achieving an     undetectable plasmatic HCV-RNA)than the current recommended in patients with chronic     hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, in HIV-coinfected     patients in real use conditions.      Method: Phase IV, postautorization, open labelled multicenter trial with a planned duration     of 118 weeks in which 71 patients from several hospitals of the Servicio Andaluz de Salud     will be enrolled. The usual clinical and analytical follow up will be performed but     additional blood samples will be obtained for determination of interferon and ribavirin     plasma levels. The primary end point wall be a sustained virologic response (defined as an     undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid     virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and     end of treatment response rates will be evaluated as well as their relationships with the     plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The     safety and tolerability of the studied medications will be evaluated by means of clinical     adverse events, physical examination and laboratory results.   "
206657|NCT00553943|"     The purpose of this study is to measure the rate of complete response (CR and UCR) at the end     of a course of immuno-chemotherapy:        -  before cerebral radiotherapy for PCL        -  after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal          involvement Toxicity of the protocol Overall survival Survival without relapse Long-term          incidence of neurocognitive toxicity   "
206658|NCT00553956|"     In the framework of the epidemiological study, local psychologists are trained in Butare in     carrying out diagnostic interviews with orphans and widows who experienced the Rwandan     genocide. With the aid of standardized questionnaires they will assess trauma related     symptoms as well as Prolonged Grief Disorder. Under the supervision of clinical experts from     the University of Konstanz the local psychologists will carry out a randomized house to house     survey (Phase 1).      As a second step, a controlled randomized clinical trial will be carried out. Local     psychologists will be trained in applying Narrative Exposure Therapy and Interpersonal     Psychotherapy. Genocide survivors that will be identified with a PTSD diagnosis will randomly     be assigned to either the treatment condition or a waiting list. The treatment group will     receive 5 individual sessions of NET in addition to 3 individual IPT sessions. Subsequent     3-months and 6-months post-tests will serve to evaluate the efficacy of this treatment module     in alleviating trauma related symptoms and symptoms of prolonged grief. We expect a     significant symptom reduction in the experimental group and no significant symptom reduction     in the waiting list. After the 6-months post-test, the trained psychologists will train other     psychologists in applying this treatment module under the supervision of clinical experts     from the University of Konstanz. Afterwards, they will apply therapy to the victims from the     waiting list.      A 12-months follow-up will serve to evaluate the long-term effect of the NET/IPT combination.   "
206659|NCT00553969|"     This study will examine the individual and combined effects of Coreg CR and lisinopril, on     cardiovascular health as measured by Rasmussen Disease Score (RDS) in a blinded, placebo     controlled comparison over a 9-month study period. Patients to be randomized will have     pre-hypertensive blood pressures that do not require anti-hypertensive therapy and at least     one additional cardiovascular risk factor.   "
206660|NCT00553982|"     Background:      The best treatment of the patella during total knee arthroplasty (TKA) is controversial. The     implantation of a patellar component adds to the operation time and the costs of the     operation.There is a huge variation as to whether the patella is resurfaced or not during     TKA. Meta-analysis of prospective, randomised trials might indicate that patellar resurfacing     reduces the risk of reoperation and anterior knee pain, but drawing firm conclusions is not     possible and additional, high quality randomised trials are required.      Purpose:      The aim of this study is to determine whether ther is a difference between the two groups in     knee pain, functions, patient satisfaction and quality of life after TKA.   "
206661|NCT00553995|"     Physical inactivity induces vascular dysfunction and glucose intolerance during five days of     bed rest. This study will investigate the effects of salsalate on these responses. Subjects     will be randomized to treatment with salsalate or placebo for four days prior to initiation     of bed rest. Vascular function in the brachial artery will be determined by ultrasound prior     to treatment and before and after the 5-day bed rest protocol. We hypothesize that treatment     with salsalate will be associated with protection again the development of glucose     intolerance and vascular dysfunction in this setting.   "
206662|NCT00554008|"     The study intends to compare the results of two surgical methods to remove the appendix in     children with appendicitis. Specifically, up to 500 children over 3 years will be placed in     two groups where the only difference in treatment is open or laparoscopic (scope) operation.     Each group will be tracked for their baseline characteristics, events during operation and     recovery, pain medication requirements, duration of hospital stay, and patient/family     satisfaction.      The investigators hypothesize that their will be no difference in the parameters measured     between the techniques of appendix removal.   "
206663|NCT00554021|"     The purpose of this study is to clarify the relationship between SIRS (Systemic inflammatory     response syndrome) and the infection associated with the use of central venous catheters at     Critical Care center in National Defense Medical College, Japan.   "
206664|NCT00554034|"     The purpose of this study is to determine the minimal number of patches needed to get an     effective response. Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a     cycle by the order they enter the study. After the first 20 patients [5 cycles], the effect     of the number of patches will be tested. If there is no distinct reduction of beta     glucuronidase in the GCF or of gingival index at the tested sites, more patients will be     enrolled. Patients will be added one cycle at a time with results being tested and analyzed.     The enrollemnts of patients will stop when a dose response will be noticed or 15 cycles have     been reached.   "
206665|NCT00554047|"     In the Netherlands a rapidly increasing number of multidisciplinary memory clinics (MMC)     currently diagnose 25% of the patients with dementia. Following the diagnostic work-up, MMCs     are increasingly involved in post-diagnosis treatment and coordination of care, which     probably is very important for patients and caregivers, but also very time consuming and     expensive. This study will focus on the important question whether this complex     post-diagnosis treatment and care coordination, evaluated both on effectiveness and costs,     should be carried out by MMCs (intervention) or by General Practitioners (GPs) (control) as     pivot of delivery of health care for these patients.      Objectives: To determine MMCs' effectiveness and cost-effectiveness in post-diagnosis     treatment and care-coordination for dementia-patients and their caregivers compared to the     post-diagnosis treatment and care coordination by GPs.      Time schedule: 12 months for including patients and their caregivers and 12 months of     follow-up.      Annex Study: Specifically for the Health Technology Assessment (HTA) methodology study the     main study will be extended with some experimental proxy measurements and alternative     measurement approaches.      The objective of this Annex-study is to explore the feasibility and validity of Health     Related Quality of Life (HRQL) value measurement in dementia patients. And to study the     characteristics of proxy rating in HRQL research in dementia and the suitability and validity     of yielding HRQL measurements by proxy assessment. Furthermore to explore the validity,     reliability, and feasibility of the EQ5D and EQ6D in dementia research (in patients and in/by     proxies); response shift, and alternative (more simple) methods of HRQL measurement and     validate the Dutch versions of the QOL-AD and the use of the CarerQol-7D in dementia     research.   "
206666|NCT00554073|"     To investigate the diagnostic performance of whole body magnetic resonance angiography     (WB-MRA) using two different magnetic resonance scanners at a field strength of 1.5 and 3T.     The hypothesis is that use of the 3T system gives superior signals from the investigated     arteries, when compared with 1.5T.   "
206667|NCT00554086|"     Multi-centre one year trial for patients who have rising PSA while on Casodex 50mg daily     dose. Casodex dosage escalated to 150 mg tablet daily. Treatment will be continued until     patient demonstrates clinical benefit at one year, PSA progression, toxicity, or withdrawal.     Treatment will be continued after one year if patient demonstrates continued clinical     benefit.   "
206668|NCT00554099|"     The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is     safe and effective in the treatment of diverticulitis.   "
206669|NCT00554112|"     This VA CDA-2 proposal will test in detail if lifestyle intervention with aerobic exercise     training improves the body's production of insulin in older people at risk to develop     diabetes.   "
206670|NCT00554125|"     The purpose of this study is to evaluate the influence of sirolimus on outcome after OLT for     HCC exceeding Milan criteria.   "
206671|NCT00554138|"     The aim of this study is to show whether rosuvastatin influences adenosine metabolism.     Therefore we will determine whether rosuvasatin increases dipyridamole-induced vasodilation     by increased adenosine receptor stimulation.   "
206672|NCT00554151|"     Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty     Ring.   "
206673|NCT00554164|"     The main purpose of the PETAL trial is to determine whether patients with aggressive     non-Hodgkin's lymphomas with a persistently positive PET scan after two cycles of     chemotherapy benefit from a change of the treatment protocol.   "
206674|NCT00554177|"     he purpose of this study is to test whether a medication, called mifepristone (commonly known     as the ³Morning-After-Pill²), can help to prevent emotional problems after someone has     survived a traumatic experience. We are studying this medication for the treatment of     Post-traumatic Stress disorder (PTSD.   "
206675|NCT00554190|"     The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat® sinus gel,     a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery.     Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus     tissues and Merogel applied to the middle meatus tissues on the opposite side.   "
206676|NCT00554203|"     Experimental studies suggest that systemic inflammation leads to endothelial dysfunction and     atherosclerosis. This study will examine the effects of the anti-inflammatory drug     sulfasalazine on endothelial function in patients with coronary artery disease. Subjects will     be treated with sulfasalazine or to placebo for six weeks. After a two-week rest period,     subjects will cross over to the alternative treatment. Endothelium-dependent flow-mediated     dilation of the brachial artery will be studied before and after each drug. We hypothesize     that anti-inflammatory therapy will reverse endothelial dysfunction in patients with coronary     artery disease.   "
206677|NCT00554216|"     The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521     compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.   "
206678|NCT00554229|"     Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054     (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.        -  This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054          (Zibotentan) can improve survival compared with placebo.        -  ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and          spread by blocking Endothelin A receptor activity. This trial will look at the effects          of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone          metastases.        -  All patients participating in this clinical trial will receive existing standard          prostate cancer treatments in addition to trial therapy.        -  Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive          placebo in addition to standard prostate cancer therapy. By participating in this trial          there is a 50% chance that patients will receive an agent that may slow the progression          of the tumour.        -  No patients will be deprived of standard prostate cancer therapy.   "
206692|NCT00554411|"     Hypothesis: Changing to Travatan Z therapy increases the tear film break up time of subjects     on Xalatan therapy presenting with ocular surface disease.   "
206693|NCT00554424|"     The purpose of this study is to see whether injecting local anaesthetic into the vaginal     tissues,just prior to transvaginal egg collection,will decrease the amount of pain     experienced by women having their eggs collected on an IVF cycle. All women will also receive     intravenous sedation as required as well as a sleeping tablet thirty minutes prior to the     procedure which is our routine procedure for egg collection.   "
206679|NCT00554242|"     A pilot study of 15 subjects will be conducted to confirm an acute effect of grape seed     extract on endothelial function. We then will perform a a randomized, double blind, placebo     controlled crossover study designed to investigate the benefit of grape seed extract/vitamin     C treatment on endothelial function. Participants (n=40) will take a food supplement     containing 450 mg of grape seed extract and 1500 mg of vitamin C or matching placebo for four     weeks and then cross over to the alternative treatment (active supplement or placebo) for     four weeks. We will examine endothelial function before and after each of the two treatment     periods. The study will provide information about the vascular effects of these compounds.   "
206680|NCT00554255|"     To investigate the safety and tolerability, PK and PD of SB751689 following single and 5-day     multiple oral doses of 100, 200, and 400 mg in Japanese postmenopausal subjects.   "
206681|NCT00554268|"     The goal of this clinical research study is to find the highest safe dose of PBI-05204 that     can be given to patients with advanced solid tumors. The study will also look at how     PBI-05204 is processed by the body, how it leaves the body, how it affects the body, and if     it is affecting certain proteins in the cancer cells.   "
206682|NCT00554281|"     Hypoglycemia is the most common complication of Type 1 diabetes particularly in those who     strive for good glycemic control. In some patients there is a loss of awareness of     hypoglycaemia so that the first manifestation of hypoglycaemia may be confusion or coma. Such     a situation may carry risks that the patient may harm him or her self. Medtronic has recently     developed a continuous glucose sensor that determines the glucose level every 3 minutes using     a subcutaneous sensor and transmits the information to a remote device (Paradigm RT) that may     be worn or left close by eg on a bedside table. The device may be programmed to alarm for a     rapidly falling glucose or for low glucose levels.      We propose to use this in 16 patients with severe hypoglycemia as evidenced by a high HYPO     score and see if we can decrease the number of hypoglycemic reactions and document this     improvement with a better HYPO score.   "
206683|NCT00554294|"     A major goal in public health is to find effective, feasible and simple programs for     overweight prevention among children. This controlled intervention study evaluates a simple     environmental and behavioral modification for its efficacy in preventing overweight of     children in the school setting. The intervention strategy focuses solely on the promotion of     drinking tap water. The study was conducted in 32 elementary schools including about 3000     children in two German cities over 1 school year.   "
206684|NCT00554307|"     The purpose of this study is to determine how the medications which are used to close the     patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow     when compared to infants that are not treated with these medications. The medications being     used for PDA closure are indomethacin and neoprofen.   "
206685|NCT00554320|"     We will rigorously test whether modulation of the motor cortex by transcranial direct current     stimulation (tDCS) is an effective treatment for patients with chronic pelvic pain through     the following specific aims:      A) The primary aim of this study is to determine whether transcranial direct current     stimulation applied to the motor cortex in patients with chronic pelvic pain induces a     significant decrease in the pain or symptoms as compared with sham tDCS. We will also measure     changes in the clinical symptom scores of multiple pelvic organs, drug intake (narcotic),     anxiety, depression, traumatic stress, as well as overall improvement in the quality of life     to assess the effects of this treatment.      B) Determine the duration of the clinical effects of tDCS. We will therefore compare the     amelioration of pain and related symptoms between active and sham tDCS for one year following     treatment.      C) Determine whether tDCS changes the threshold for pain detection as compared with sham     tDCS. Patients with chronic pelvic pain have a lower threshold for pain as compared to     healthy subjects and we hypothesized that this threshold will increase after stimulation with     tDCS.      D) Finally, we will examine whether 5 days of tDCS treatment is safe for use in chronic     pelvic pain patients. Safety will be assessed through neuropsychological tests and adverse     event reporting.   "
206686|NCT00554333|"     Primary objective:      * Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route     at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular     route at the same dosage in term of HA antibody titres      Secondary objectives        -  Immunogenicity             -  To describe the immune response 21 days after vaccination with the influenza               vaccine administered by ID route versus the adjuvanted influenza vaccine               administered by IM route..             -  To describe the compliance of both vaccines administered with the European Medicine               Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly               subjects        -  Safety           - To describe the safety profile after vaccination in each group        -  Acceptability             -  To describe the pain at the injection site             -  To describe the comfort of the injection   "
206687|NCT00554346|"     Post surgical pain associated with ligament reconstruction may persist for few days after the     surgical procedure. Arcoxia is a new anti-inflammatory and analgesic drug that alleviate pain     through oral administration. This study will test the safety and efficacy of Arcoxia in the     management of post-operational pain in patients receive the ligament reconstruction surgery.   "
206688|NCT00554359|"     This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic     study. The study will be conducted in approximately 8-10 centers in the United States and     Switzerland. Up to 32 patients who have undergone major cardiovascular surgery will     participate. Patients will receive a single IV injection of I5NP or placebo following     cardiovascular surgery. I5NP will be administered 4 hours (+/- 30 minutes) following removal     of the cardiopulmonary bypass machine (CBM).      The duration of the study is approximately 44 days, inclusive of a 14 day screening period.     Patients will be contacted by phone at 6 and 12 months for follow-up questions. Patient     visits are screening, day of surgery, hospital in-patient Days 1, 2, 3 and Day 7 or hospital     discharge. Safety follow-up will continue until 30 days post-surgery. 2 phone calls will be     made at 6 and 12 months after date of surgery.   "
206689|NCT00554372|"     The purpose of this research study is to determine whether JX-594 (Pexa-Vec) has significant     anti-tumoral activity and tolerability in primary hepatocellular carcinoma and to determine     the dose to be used in further testing.   "
206690|NCT00554385|"     The objective of this study is to evaluate the long-term safety and tolerability of ABT-089     in children with ADHD.   "
206694|NCT00554437|"     Intensive falls prevention programs have been shown to be effective in reducing falls;     however, a number of practical programs, based in community setting have not been successful     at reducing rate of falls. The purpose of this study was to test, in a randomized, controlled     trial, the efficacy of this intermediate-intensity, individual, multifactorial model to     reduce falls. It was hypothesized that more contacts would lead to greater adherence and     efficacy in reducing falls.   "
206695|NCT00554450|"     The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance     in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type     2 diabetic and healthy subjects with normal renal function   "
206696|NCT00554463|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Colony-stimulating     factors, such as G-CSF or pegfilgrastim, may increase the number of immune cells found in     bone marrow or peripheral blood and may help the immune system recover from the side effects     of chemotherapy and radiation therapy.      PURPOSE: This phase II trial is studying G-CSF and pegfilgrastim to see how well they work in     treating neutropenia in patients undergoing combination chemotherapy and radiation therapy     for limited stage small cell lung cancer.   "
206697|NCT00554476|"     To compare the effectiveness of two combined therapeutic methods including corticosteroid     injections with elbow cast versus ice massage and non-steroidal anti inflammatory drugs     (NSAIDs).   "
206698|NCT00554489|"     RATIONALE: Physical activity sessions may help improve physical function, quality of life,     and symptoms caused by chemotherapy in older patients with acute myelogenous leukemia.      PURPOSE: This clinical trial is studying how well physical activity works in improving     quality of life in older patients with acute myelogenous leukemia undergoing chemotherapy.   "
206699|NCT00554502|"     -  Evaluation of the efficacy of an immunosuppressive therapy added to a comprehensive          supportive therapy to induce a clinical remission in patients at risk for progressive          IgAN        -  Investigation of differences between the treatments regarding the number of patients          loosing more than 15 ml/min of GFR.   "
206700|NCT00554515|"     High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug     Administration (FDA) for the treatment of metastatic kidney cancer and is a standard     treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer     that can produce a remission of disease that lasts after treatment is completed. However,     most patients who receive IL-2 do not benefit and all patients experience potentially     dangerous side effects.      Recent research has suggested that certain patients may respond better to IL-2 than others.     The Cytokine Working Group is currently conducting a clinical trial that aims to identify and     confirm this research and narrow the application of IL-2 to those patients most likely to     benefit.   "
206701|NCT00554528|"     The aim of the study is to evaluate the impact of the cervical disk surgery on the     deterioration of the adjacent levels. The investigators compare the radiological     deterioration of adjacent levels, at 3 years, in both situation of fusion and arthroplasty.     220 patients are enrolled and randomized to receive fusion or prosthesis. Radiological and     clinical follow-up is organized for a period of 3 years.   "
206702|NCT00554541|"     This research project is investigating the relationship between body weight and function of     the leg veins using a special non-invasive technique known as venous plethysmography.   "
206703|NCT00554567|"     This community-based clinical trial based in two districts of rural Maharashtra, India     compares utilization of an intervention model of fully-decentralized, or rural primary     clinic-based, HIV testing and care services, with a control model of the Indian government's     partially-decentralized HIV services, offering rural referral clinic testing and urban-based     HIV care.   "
206704|NCT00554580|"     The investigators hypothesise that CPAP + pharmaceutical treatment, compared to     pharmaceutical treatment alone, improves the respiratory and hemodynamic status of the     patients before H2 after the inclusion time and decreases the rate of death and tracheal     intubation during the first 48 hours.   "
206705|NCT00554606|"     This study will assess the long-term safety and tolerability of ACZ885 in patients with     rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or     improvement of joint structure and bone mineral density, and long term maintenance of     health-related quality of life.   "
206706|NCT00554619|"     The primary objective of this study is to evaluate the safety of long-term administration of     GSK1325760A in patients with PAH.      The secondary objectives of this study are to evaluate long-term administration of     GSK1325760A on:        -  Improvement in exercise capacity (six-minutes walk distance: 6MWD), change in WHO          Functional Classification and time to clinical worsening of PAH        -  Change in the Borg Dyspnea Index (assessed immediately following the six-minute walk          test [6MWT])        -  Change in plasma brain natriuretic peptide (BNP) levels        -  Cardiopulmonary hemodynamics parameters (as measured by echocardiography)   "
206707|NCT00554632|"     This study was a randomized, investigator-blinded, cross-over, clinic trial using twenty-four     healthy women aged 18-35. All women received two months of the birth control patch or birth     control pill, two months without any drug, then two months of the alternative drug. The birth     control patch contained 0.75 milligrams ethinyl estradiol and 6 milligrams norelgestromin.     The birth control pill contained 35 micrograms ethinyl estradiol and 250 micrograms     norgestimate. Blood samples were taken before and after each treatment and were analyzed for     the following lab values: D-dimer, von Willebrand factor, factor VIII, total and free protein     S, antithrombin, fibrinogen, C-reactive protein and normalized activated protein C     sensitivity ratio (nAPCsr). Two thrombin generation-based assays were used: the     α2macroglobulin-thrombin endpoint method (α2M-IIa) and calibrated automated thrombinography     (CAT).   "
206708|NCT00554645|"     The difficulties in loosing weight may not stem from lack og knowledge about nutrition, as     implied by the standard treatment but from difficulties in following the advice. The     hypothesis is, that revealing and addressing these difficulties psychotherapeutically may be     more efficient in obtaining weight reduction. The effect of psychological group treatment of     severely overweight children and their parents is compared with traditional nutritional     information. In other words: Which is better: back-up or enlightenment?   "
206709|NCT00554658|"     Aim of the study is to assess the effect of quetiapine treatment in neuroleptic naive,     first-episode schizophrenic patients on aspects of functional and structural neuroplasticity     assessed by means of transcranial magnetic stimulation and voxel-based morphometry. Main     outcome measure is a change in gray matter density under quetiapine treatment from baseline     to steady-state-treatment after 3 weeks.   "
206710|NCT00554671|"     This is a multi-site open label randomized controlled study of patients with type 2 diabetes     undergoing pharmacist-led group medical visits that include education by a multi-disciplinary     personnel, behavioral modification and pharmacotherapy case management vs. usual care   "
206711|NCT00554684|"     1. Patients greater than 90 years of age will have poorer outcomes in terms of mortality          than younger patients controlling for disease and acuity        2. Patients greater than 90 years old will consume more resources than younger patients          controlling for disease and acuity        3. Patients greater than 90 years old will show lower levels of function than younger          patients controlling for disease and acuity        4. Patients greater than 90 years old will show lower levels of HRQOL at 90-120 days post          ICU discharge than younger patients controlling for disease and acuity   "
206712|NCT00554697|"     The purpose of this study is to determine whether diabetics have decreased amounts of oxygen     in the skin compared to non-diabetic individuals, and if the amount of oxygen in the skin     changes when given more oxygen to breathe around the time of surgery. To do this, the     investigators will be measuring the amount of oxygen in the skin of diabetic and non-diabetic     individuals who will be undergoing abdominal surgery lasting 2-4 hours. These measurements     will be taken at three different times.   "
206713|NCT00554710|"     The study prospectively compares two treatment algorithms for newly diagnosed Crohn's     disease: one 'aggressive' treatment with early introduction of immunomodulators and     biologicals and one 'standard treatment' with corticosteroids and only later introduction of     immunosuppressives and biologicals if disease activity requires that.   "
206714|NCT00554723|"     CHIMES is a double blind, placebo controlled, randomized, multicenter study to test the     hypothesis that NeuroAid is superior to placebo in reducing neurological deficit and     improving functional outcome in patients with cerebral infarction of an intermediate range of     severity.   "
206715|NCT00554736|"     This is a placebo controlled double-blind single center study initiated and sponsored by     CALPIS, Inc., Japan, and CALPIS U.S.A., Inc., Torrance, CA.      The overall objective of this study is to establish the benefit of a bacterial product,     Lactobacillus acidophilus strain L-92 (CALPIS U.S.A., Inc., Torrance, CA), in patients with     allergic rhinitis.   "
206716|NCT00554749|"     The purpose of this pilot study is to explore the outcome of a manual based treatment for     children with Selective Mutism   "
206717|NCT00554762|"     The purpose of this study is to assess the dose response and efficacy of single and repeat     doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.   "
206718|NCT00554775|"     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib     may also make tumor cells more sensitive to radiation therapy. It is not yet known whether     giving whole-brain radiation therapy together with erlotinib is more effective than     whole-brain radiation therapy alone in treating patients with non-small cell lung cancer and     brain metastases.      PURPOSE: This randomized phase II trial is studying whole-brain radiation therapy and     erlotinib to see how well they work compared with whole-brain radiation therapy alone in     treating patients with advanced non-small cell lung cancer and brain metastases.   "
206719|NCT00554788|"     This phase III trial is studying the side effects and how well giving combination     chemotherapy together with autologous stem cell transplant and/or radiation therapy works in     treating young patients with extraocular retinoblastoma. Giving chemotherapy before an     autologous stem cell transplant stops the growth of tumor cells by stopping them from     dividing or killing them. After treatment, stem cells are collected from the patient's blood     and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the     stem cell transplant. The stem cells are then returned to the patient to replace the     blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high     energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy     and/or autologous stem cell transplant may kill any remaining tumor cells.   "
206720|NCT00554801|"     The incidence of central auditory dysfunction in war fighters who are exposed to     high-explosive blasts while serving in combat have not been clearly determined. The     objectives of this study are to determine whether central auditory processing (CAP) disorders     are associated with exposure to high-explosive blasts. This study will also examine the     incidence, magnitude and timing of spontaneous recovery of CAP function from blast exposure.     The information provided by this study will help guide clinicians in both the military and VA     health care systems regarding the likelihood of central auditory processing disorders in     soldiers returning from deployment and suggest some clinical rehabilitative strategies for     the treatment of these patients with CAP deficits.   "
206721|NCT00554814|"     The primary purpose of the study is to demonstrate the superiority of Bledilait milk (Biofer®     2mg/100kcal) in comparison with ferrous sulphate supplemented milk (2 mg/100 kcal) in infants     (6 to 12 months) with latent iron deficiency by measuring serum ferritin value after 2 months     of consumption of studied milks.   "
206722|NCT00554827|"     This study is being conducted to identify how much and how often pralatrexate, given with     vitamin B12 and folic acid, can be given safely to patients with cutaneous T-cell lymphoma     (CTCL) that has relapsed (returned after responding to previous treatment) or is refractory     (has not responded to previous treatment). It is also being conducted to get information on     whether or not pralatrexate is effective in treating relapsed or refractory CTCL.   "
206723|NCT00554840|"     The purpose of this proposed pilot study is to examine the use of varenicline in people with     schizophrenia to specifically assess tolerability and efficacy for smoking cessation.     Specifically, The primary objective of this pilot study is to determine if taking of     varenicline along with an individual smoking cessation supportive program is a safe and     effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the     varenicline treated patients will achieve higher rates of smoking cessation than those who     receive placebo and individual support.   "
206724|NCT00554853|"     Patients with rheumatoid arthritis have a significantly higher risk to develop heart attacks     and other complications of their blood vessels. New therapies are needed to prevent this     complication. The purpose of this study is to establish the role of the medication     pioglitazone in improving the function of the blood vessels and heart and decreasing the risk     of future atherosclerosis development in individuals with rheumatoid arthritis. As a     secondary aim-point, we will evaluate the efficacy of pioglitazone in improving rheumatoid     arthritis disease activity and markers of inflammation.   "
206725|NCT00554866|"     Plasma L-arginine concentrations are decreased in premature infants with necrotizing     enterocolitis (NEC). A carbamoyl-phosphate synthetase 1 (CPS1) polymorphism has been     correlated with low plasma concentrations of L-arginine in neonates (> 35 weeks of     gestation). Recently Moonen et al (Pediatr Res 2007; 62(2):188-90) described a correlation     between this CPS1 T1405N single nucleotide polymorphism (SNP) and the presence of NEC in VLBW     infants. However there is no data about the correlation between the plasma arginine     concentrations and the T1405N SNP in the CPS-1 gene in VLBW infants. In the present project     we postulate that T1405N SNP in the CPS-1 gene is associated with lower plasma arginine     concentrations and is also a risk factor for the development of NEC.   "
206726|NCT00554879|"     The purpose of this study is to determine the safety and efficacy of acupuncture in the     treatment of moderate to severe dry eye by replicating the study design of the previous     protocol and to see the study through to its completion.   "
206727|NCT00554892|"     The aim of this controlled multicentric study is to assess rectal cancer surgery with     sphincter preservation without pre operative mechanical bowel preparation   "
206728|NCT00554905|"     The purpose of this study is to prospectively evaluate whether combined RFA and TACE     (RFA-TACE) result in better survival outcomes than RFA alone in patients with HCC.   "
206729|NCT00554918|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisolone, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Zoledronic acid may help relieve some of the symptoms caused by bone metastases.     Radioactive substances, such as strontium chloride Sr 89, may help relieve bone pain caused     by prostate cancer. Giving docetaxel together with prednisolone with or without zoledronic     acid and/or strontium chloride Sr 89 may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying the side effects and how well giving     docetaxel together with prednisolone works with or without zoledronic acid and/or strontium     chloride Sr 89 in treating patients with prostate cancer metastatic to bone that has not     responded to hormone therapy.   "
206730|NCT00554944|"     The investigators propose to determine esophageal Doppler goal-directed fluid requirements in     lean, overweight, obese, and morbidly obese patients with the goal of developing a body mass     index (BMI)-specific fluid replacement strategy. Specifically, th investigators will test the     hypothesis that perioperative fluid requirements on a per-kg basis varies as a function of     BMI. Individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or     genital prolapse repair will be eligible to participate   "
206731|NCT00554957|"     The annual frequency of injury among dancers has been reported to range between 23-84% while     as many as 95% of professional dancers have ongoing pain. The discrepancy between the number     of reported injuries and the amount of pain reported at any given time could be related to     the definition of injury, or how dancers' themselves perceive injury with respect to pain and     activity limitation thresholds. For many reasons, dancers may be dancing through or past what     health care providers may conceive as injury. This can put them at risk of further or chronic     injury. The purpose of this study is to understand at which point pain limits a dancer's     ability to continue to perform and whether this is influenced by available medical services,     a supportive dance environment, or other factors. In addition, the issue of non-reporting of     injuries will be studied. This is very important as this will affect all measures of injury     frequency and risk for dancers.   "
206732|NCT00554970|"     The purpose of this study is to examine the blood levels of two doses of MAP0010 (a     corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with     twice daily dosing over 7 days.   "
206733|NCT00554983|"     Efficacy and Safety from a recombinant folding variant of Bet v 1   "
206734|NCT00554996|"     This study is a prospective pilot clinical trial investigating the use of urinary catheters     coated with benign E. coli in geriatric subjects.   "
206735|NCT00555009|"     To establish the effects of genotropin replacement on cognitive function in patients with     severe growth hormone deficiency after traumatic brain injury.   "
206736|NCT00555022|"     GSK1160724 is a potent mAChR antagonist, which is being developed for treatment of chronic     obstructive pulmonary disease (COPD)   "
206737|NCT00555035|"     To determine safety, tolerability and pharmacokinetics of GSK1349572   "
206738|NCT00555048|"     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill     them or deliver cancer-killing substances to them without harming normal cells. Giving     chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell     transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor     can make an immune response against the body's normal cells. Giving tacrolimus and     methotrexate after the transplant may stop this from happening.      PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together     with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how     well it works in treating patients with hematologic cancer.   "
206739|NCT00555061|"     A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects     (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses,     or impetigo (bullous and non-bullous).   "
206740|NCT00555074|"     The purpose of this study is to compare the efficacy and safety of sodium tungstate versus     placebo in patients with obesity (grade I and II).   "
206769|NCT00555451|"     The objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of     HE3286 when administered daily for 28 days to obese adult subjects and to assess potential     activity of HE3286 to decrease insulin resistance. An open-label cohort of 6 patients with     type II diabetes mellitus will be treated at 10 mg (5 mg BID).   "
206741|NCT00555087|"     The main objective of this study is to evaluate the response of erectile dysfunction in     hypogonadotrophic males with Testosterone undecanoate i.m. as per IIEF and the question of     the GAQ (Global Evaluation Questionnaire) after 42 weeks of treatment.      Secondary Study Objectives        -  To monitor adverse events and changes in hemoglobin and serum chemistry with: PSA, lipid          profile, renal-hepatic profile and glycemia, and control by means of a rectal digital          examination.        -  To Determinate physiologic reconstitution in patients under treatment by means of total          and free testosterone dosage.   "
206742|NCT00555100|"     CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD),     safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without     dexamethasone in Japanese subjects with previously treated MM. The study will consist of two     cohorts: 1) Monotherapy Maximum Tolerated Dose (MTD) Determination Cohort; and 2)     Combination Treatment Cohort.   "
206743|NCT00555113|"     Pseudoxanthoma elasticum is a disease whom frequency is estimated about 1/50000 to 1/100 000.     There is a female preponderance with a sex-ratio of 2:1. PXE is transmitted according either     to an autosomal dominant mode or to an autosomal recessive one. Mutations in the ABCC6 gene     on chromosome 16p13.1 have recently been identified causing PXE. The elastic fibers slowly     become mineralized mainly in the skin, the eyes, and the cardiovascular system. PXE is a     multisystem disease that includes a spectrum of clinical manifestations affecting the skin,     the eye or the cardiovascular system as well as other tissues. It can be responsible for     severe and life threatening complications. Skin changes are usually the first manifestations     and begin in early childhood. The vital prognosis of PXE depends on the severity of the     cardiovascular lesions that could be responsible for sudden death in children and young     adults.      Ocular manifestations are quite constant and include chorioretinal scarring, pigmentary     changes or angioid streaks. The natural evolution of the angioid streaks leads to their     enlargement or to the occurrence of subfoveal choroidal neovascularizations and hemorrhages     leaving macular scares. A self-monitoring is recommended since early treatment of subfoveal     CNV is the only way to minimize their pejorative consequences. The gold standard treatment of     the CNV consists in the photocoagulation. New therapeutics has been developed including     photodynamic therapy or intravitreal injection of anti-angiogenic agents and they seems to be     effective to reduce the immediate complications of a limited CNV. This evolution explains     that 50 to 70 % of the patients have a poor vision or legal blindness of one or both eyes.     However, little is known about the age of occurrence of visual impairment in PXE patients.     That is the reason why we decided to review the ophthalmologic status and visual history of     our population of PXE patients according to their age.   "
206744|NCT00555126|"     Trauma is the leading cause of death in young adults, bleeding and infection are major     concomitant problems. We test the hypothesis that fast, perioperative warming with an     endovascular catheter versus forced air warming may improve patient outcome (primary outcome:     combined perioperative morbidity, secondary outcome: bleeding, infection).   "
206745|NCT00555139|"     To compare by neuroimaging techniques and public speaking, the way social anxiety patients     respond after the administration of GW876008, GSK561679, alprazolam and placebo   "
206746|NCT00555152|"     This randomized phase I/II trial studies the side effects and best dose of lapatinib     ditosylate and to see how well it works in treating patients with ductal breast carcinoma in     situ. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.   "
206747|NCT00555165|"     Evaluation of pre and post−implantation management of patients with end−stage age−related     macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under     CE Mark indicated use. This study is designed to evaluate in particular the optimal     parameters for patient selection for use of this device in routine clinical practice.   "
206748|NCT00555178|"     Polymorphic light eruption (PLE) is a photodermatosis with an extremely high prevalence,     particularly among young women (up to 20%). The disease is characterized through itchy skin     lesions on sun-exposed body sites occurring after sun exposure mostly in spring and early     summer. Its etiopathogenesis is unknown but resistance to UV-induced immunosuppression with     subsequent immune reactions against skin photoneoantigens has been suggested. Regulatory T     cells (CD4+CD25+FoxP3+) (Tregs), a subset of T helper cells, are crucial for the induction of     immunosuppression. We will test the hypothesis that PLE patients show pathogenic fluctuating     Treg levels and function and related parameters over the seasons of the year, possibly being     responsible for lack of immune modulation and autoimmunity in PLE. Natural or medical     photohardening may normalize Treg deficiency in PLE and lead to clinical adaption in summer.     Better insight into the pathogenesis of PLE may give clues to develop new therapeutic     strategies.   "
206749|NCT00555191|"     Different published studies has shown a possible co-variation between leakage of fructose to     the great bowel and exacerbation of irritable bowel syndrome (IBS) symptoms.      The aim of the FINN trial is to study the role of fructose malabsorption in patients with IBS     in order to evaluate different diagnostic criteria for fructose malabsorption and at the same     time study the effect of diet treatment in this cohort of patients and estimate the     prevalence of fructose malabsorption.   "
206750|NCT00555204|"     The purpose of this study is to test if the investigational medication ABT-089 is a safe and     effective treatment for Alzheimer's disease.   "
206751|NCT00555217|"     Diabetes is the leading cause of end-stage renal disease (ESRD) in the United States. The     overall rate of ESRD secondary to diabetes has risen 68% since 1992. Medications that block     the renin angiotensin system have been shown to decrease the progression of diabetic     nephropathy. The use of an angiotensin receptor blocker (ARB) has been shown to decrease the     risk of progression of kidney disease in two studies of individuals with Type 2 diabetes and     proteinuria. Despite the use of an ARB, the incidence of renal failure remained high in the     treated group in both studies. The combination of an angiotensin converting enzyme inhibitor     (ACEI) and ARB can lead to more complete blockade of the renin angiotensin system. In     diabetic kidney disease, combination therapy has been shown to decrease proteinuria in     short-term studies. Although there are encouraging results for improvement in proteinuria     there are no data on progression of kidney disease for the use of combination of ACEI and ARB     therapy in patients with diabetes. In addition, there could be an increased risk of serious     hyperkalemia in individuals with diabetes who receive combination ACEI and ARB. The     investigators therefore propose a randomized double blind multi-center clinical trial to     assess the effect of combination of ACEI and ARB in patients with diabetes and proteinuria on     progression of kidney disease.   "
206770|NCT00555464|"     The goal of this study is to determine the safety and efficacy of Prednisolone and     Vincristine for treatment of large, complicated infantile hemangiomas. The diagnostic,     therapeutic and response criteria experimentally determined in this study will be used as a     framework for future infantile hemangioma studies.   "
206752|NCT00555230|"     The purpose of this study is:        1. To evaluate the prevalence of preclinical atherosclerosis in Chinese patients with RA          compared to healthy controls.        2. To determine those clinical and biological measures that best predict the presence of          plaque and increased arterial stiffness.        3. To ascertain the efficacy and safety of rosuvastatin in the prevention of          atherosclerosis in patients with RA measured by carotid intima-media thickness (IMT) and          pulse wave velocity (PWV).   "
206753|NCT00555243|"     The primary goal of this study is to answer whether validated laparoscopic simulators truly     affect real time performance in the operating room among Gynecology residents.   "
206754|NCT00555256|"     To define the optimal dose of sunitinib when given in combination with rapamycin 2mg.      To determine the maximum tolerated dosage of sunitinib and rapamycin given in this fashion.      To determine the how many times and how severe other toxicities of this combination therapy.      To determine how quickly the patient(s) will respond the the drug, overall survival and time     to progression for this combination therapy.   "
206755|NCT00555269|"     To compare possible toxicities of membrane blue and infracyanine green in vivo by macular     function and peripheral visual field.   "
206756|NCT00555282|"     The use of these catheters is associated with infectious complications that are an important     iatrogenic source of morbidity and mortality. Certofix® protect is a catheter with a surface     modified in order to reduce colonization by bacteria. This clinical trial is performed to     compare the safety and efficacy of the coated central venous catheter, Certofix® protect,     with that of the non-coated standard catheter Certofix®.   "
206757|NCT00555295|"     The purpose of this study is to determine the survival after laparoscopic colectomies due to     carcinoma.   "
206758|NCT00555308|"     An Emergency Department Targeted Ultrasound (EDTU) is an ultrasound examination performed by     an emergency department physician, instead of a radiologist or ultrasound technician. EDTU is     intended to be a readily assessable test performed at the bedside, to quickly and safely     determine the presence of a disease state; it answers a binary question, as compared to     formal ultrasound imaging which seeks to determine the cause of a patient's symptoms.      The objective of this study is to determine the accuracy of EDTU in patients suspected of     renal colic. By demonstrating excellent test characteristics, these investigators hope that     this research will be used to incorporate EDTU for hydronephrosis into standard emergency     care in Canada.   "
206759|NCT00555321|"     The purpose of this clinical research study is to evaluate the effects of belatacept,     relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects     receiving a liver transplant   "
206760|NCT00555334|"     The purpose of the investigators' study is to prospectively evaluate whether nucleoid     antiviral therapy will improve the outcome of radiofrequency ablation for hepatocellular     carcinoma (HCC).   "
206761|NCT00555347|"     To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.   "
206762|NCT00555360|"     Informal caregivers, assisted by health information technology may help to fill the gaps in     VA care management of heart failure patients by enhancing support for patients' treatment     adherence, behavior changes, and symptom monitoring.   "
206763|NCT00555373|"     Damage and scarring of a transplanted kidney has become the most common cause of loss of the     transplanted kidney. This kidney damage is a complex process caused by many factors including     injury during obtaining and transplanting the kidney, injury from the immune system, injury     from infections, and injury from drugs used to stop rejection. This injury leads to scars     that decrease the kidney's ability to function properly, and over time the kidney is lost.     Prograf® (tacrolimus) has been one of the main drugs used to prevent rejection. However, when     used over time it has been shown to cause chronic damage and scarring in the transplanted     kidney.      The purpose of this experimental study is to determine whether children can safely be     withdrawn from Prograf® after transplantation and changed to Rapamycin® (sirolimus). Recent     research studies in adult transplantation have demonstrated that with the use of Rapamycin®     (sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase     in rejection, with decreased scarring in the kidney, and with improvements in kidney function     and survival of the kidney. A total of 50 children will enroll in this study at university     centers around the country. This study will last about 3 years.   "
206764|NCT00555386|"     There is evidence to suggest that some dietary components can reduce the risk of breast     cancer. In this pilot study two such components, isoflavones (compounds found in soy     products) and selenium, will be given to women classed as at moderate to high risk of the     disease. The aim is to determine some novel biomarkers of risk and to see the effect of     supplementation on them.   "
206765|NCT00555399|"     The goal of this clinical research study is to learn if vorinostat when given with     isotretinoin and temozolomide can help to control glioblastoma or gliosarcoma. The safety of     these drug combinations will also be studied.   "
206766|NCT00555412|"     The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of     multiple inhaled doses of Staccato Loxapine.   "
206767|NCT00555425|"     The aim of the study is to determine whether buprenorphine/naloxone maintenance versus     detoxification using buprenorphine/naloxone, in prescription opioid dependent patients     receiving primary care management and drug counseling in an office-based setting, leads to     decreased illicit opioid use.   "
206768|NCT00555438|"     Fondaparinux is an antithrombotic agent having already received a regulatory approval by the     European Authorities in venous thromboembolic event prevention after major orthopaedic     surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The     bleeding risk associated with this prescription is highly related to renal function evaluated     by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to     prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of     2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated     pharmakinetic data without any support of clinical data.      prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5     mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl     between 20 and 30 ml/min and undergoing a major orthopaedic surgery.   "
207080|NCT00552422|"     The purpose of this study is to examine the clinical response to domperidone in solid organ     transplant recipients with gastroparesis.   "
206771|NCT00555477|"     Women with hormone-receptor positive breast cancer are typically treated with hormone therapy     as part of their treatment after surgery. In the past few years it has been found that     treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women.     Tamoxifen is still used for premenopausal women, however, because aromatase inhibitors are     not effective in women who have functioning ovaries. Some women are premenopausal at the time     they are diagnosed with breast cancer, but then stop having menstrual periods when they are     treated with chemotherapy. It is unclear if these women can also be treated safely with     aromatase inhibitors.      In this clinical trial the researchers will try to answer this question. Women with hormone     receptor positive breast cancer who become postmenopausal with chemotherapy will be invited     to participate in this study. Each woman will be treated with one of the aromatase     inhibitors, anastrozole (Arimidex), and then carefully monitored to ensure that her ovaries     do not start making estrogen. If her estrogen level remains low, then she will continued to     be followed for 18 months. If the level increases to the level typically seen in     premenopausal women, however, then she will stop taking part in this study.      The study will also evaluate multiple factors that may help doctors predict who will tolerate     the therapy without having their ovaries start making estrogen again. Some of the factors to     be evaluated include other hormone levels (blood tests) as well as family history of early     menopause (mother, sisters). In addition, changes in certain genes that affect how patients'     bodies handle chemotherapy drugs will be tested to see if they affect whether or not patients     recover ovarian function. Overall, the purpose of the study is to determine which patients     who become postmenopausal from chemotherapy are likely to tolerate aromatase inhibitor     treatment safely, and how often the patients' ovarian function needs to be tested during     treatment.   "
206772|NCT00555490|"     we conducted a longitudinal 4-year clinical trial to determine the long-term effects of soy     consumption on lipid profiles, renal-function indices and CRP level among type 2 diabetic     patients with nephropathy.   "
206773|NCT00555503|"     This is a registry for patients who have a risk-reduction mastectomy (prophylactic     mastectomy) due to being at high risk for developing breast cancer, followed by breast     reconstruction. Eligible patients include those who have a breast cancer-related gene, a     strong family history of breast cancer, or a personal history of high-risk conditions such as     cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the     registry before surgery, and are followed for up to ten years afterwards. In addition to     studying medical outcomes, we will periodically survey patients for quality-of-life issues     and psychological well-being. There is no compensation for being enrolled in this registry.     This registry is conducted through the Department of Plastic Surgery at Georgetown University     Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi     Comprehensive Cancer Center at Georgetown University.   "
206774|NCT00555516|"     Study Hypothesis:      EW02 is a polysaccharide-enriched crude extract from black soybean (BS). BS has been used     extensively by the Chinese as food or traditional Chinese medicine for hundreds of years. It     has been used as monotherapy to treat Diabetes, menorrhagia and leukorrhea. In combination     with others, BS has been used to treat chemotherapy-induced leukopenia on more than 300 pts.     The daily doses were 15g bid to 50g tid for 21 days. Side effects were generally mild,     including epigastric discomfort, numbness, insomnia, and dry mouth. Recently BS was found to     promote myelopoiesis and inhibit tumor growth through immunomodulation. In vitro assays     showed BS-PS can stimulate production of cytokines and increase blood progenitors. In vivo     studies also demonstrated that BS-PS can reduce neutropenia in mice received 5-FU by     stimulating myeloid colony formation. We hypothesize that EW02 can reduce neutropenia in     cancer patients who receive chemotherapy without side effects.   "
206775|NCT00555529|"     -  The purpose of this project is to validate the peripheral arterial pressure waveform          measurements technique of RAAP (radial artery applanation tonometry), in patients with          moderate and severe COPD (Chronic Obstructive Pulmonary Disease), and to assess the          degree of systemic endothelial dysfunction in these patients compared to cigarette          smokers with normal lung function and non-smokers with normal lung function.        -  Patients with moderate and severe COPD (GOLD stage II and III) will be studied and their          results will be compared with age-matched healthy non- smokers and smokers.        -  RAAP will be taken every 5 minutes for 15 minutes before salbutamol and every 5 minutes          for another 15 minutes after salbutamol.        -  Several parameters of lipoprotein profiles, anti-oxidant plasma capacity, inflammatory          cytokines, hormones, growth factors and vascular cell adhesion molecules will be studied          in blood. In addition, several inflammatory and oxidative markers will be studied in          exhaled breath condensate. Lung function and impulse oscillometry will be made to          investigate airway resistance, and exhaled NO (nitric oxide) at different expiratory          flows will be measured to assess alveolar and bronchial NO. Clinical assessment          including dyspnoea and depression scores will also be made.   "
206776|NCT00555542|"     To study the effects of T cell in peripheral blood of patients with RA undergoing selective B     cell depletion have not been studied. We analyze the B and T cell subsets in patients with     active RA treated undergoing this form of treatment with rituximab.   "
206777|NCT00555555|"     To assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in     preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD)     who undergo surgical procedures.   "
206778|NCT00555568|"     The objective of this study is to examine the mechanisms of action and outcome in mental     health peer support groups. The study design is a randomized trial in which participants are     assigned to one of three study arms: a recovery oriented mental health group led by peer     facilitators (Vet-to-Vet), a recovery oriented group led by a clinician, or treatment as     usual. Qualitative and quantitative methods will be used to assess substantive content and     process of the recovery groups, as well as mental health and recovery outcomes.   "
206792|NCT00555750|"     The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps     people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S.     Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in     the United States as LUNESTA.      Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that     can be reversed by two months of eszopiclone for the primary insomnia   "
206793|NCT00555763|"     The classic Goldmann applanation tonometer has been further developed. The applanation     principle has been retained, while the internal force transmission and the pressure gauging     have been optimized, and the display of results digitized.      The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with     the new version of the device, and to test the reliability and reproducibility of     measurements, as well as its safety.   "
206794|NCT00555776|"     The purpose of this study is to determine wether Gabapentin which is useful for treating     neuropathic pains, is effective on idiopathic subjective tinnitus.   "
206795|NCT00555789|"     This study will provide continued treatment and assess the long term safety, efficacy and     tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after     kidney transplantation.   "
206779|NCT00555581|"     The purpose of this study is to assess the safety and tolerability of imatinib mesylate     (Gleevec) in patients with systemic sclerosis (scleroderma). Gleevec is a medication already     FDA approved for the treatment of chronic myelogenous leukemia (CML), gastrointestinal     stromal tumors (GIST), dermatofibrosarcoma protuberans tumors, Philadelphia     chromosome-positive acute lymphoblastic leukemia, hypereosinophilic syndrome, and aggressive     systemic mastocytosis. In-vitro studies have suggested that imatinib may inhibit collagen     production by scleroderma fibroblasts, and in mouse models of fibrosis imatinib has been     shown to decrease skin thickness.      This is a Phase IIa, single center, prospective open label clinical trial of Gleevec in     patients with systemic sclerosis. All patients will be treated with active drug for 12     months. The primary objective of this study will be to determine the safety and tolerability     of Gleevec in patients with systemic sclerosis, but important secondary outcomes of relevance     will be improvement in disease status as defined by skin scores and indices of pulmonary     function.      Patients who complete the initial phase (described above) of the study will be eligible to     participate in an extension phase. The purpose of the extension phase of the study is to give     patients who participated in the phase IIa clinical trial of Gleevec at the Hospital for     Special Surgery the opportunity to continue Gleevec treatment if both the treating physicians     and the patient are in agreement that Gleevec had acceptable safety and tolerability, as well     as possible efficacy during the initial year of therapy.   "
206780|NCT00555594|"     To determine the effect of subconjunctival Bevacizumab in corneal neovascularization   "
206781|NCT00555607|"     The aim of the project is to study pathogenetic mechanisms in severe asthma and compare those     mechanisms in chronic obstructive pulmonary disease (COPD) in order to test the hypothesis     that severe asthma and COPD develop into similar chronic degenerative changes.   "
206782|NCT00555620|"     The purpose of the study is to determine the safe and tolerable doses of sunitinib given     together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients     who have advanced gastric cancer who have not received prior chemotherapy for their advanced     cancer   "
206783|NCT00555633|"     Study aim: To determine the effect of an intensified daily photoprotection over 24 months     with an SPF30 sunscreen and an after sun-lotion both containing liposomal DNA repair enzymes     in a population of patients at high-risk for skin cancer, including xeroderma pigmentosum     (XP) and basal cell nevus syndrome.   "
206784|NCT00555646|"     This is an open label, single center, controlled study with each subject's two treatment     plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and     (b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no     treatment and serve as a control.      Subjects with at least three distinct, stable study plaque areas will receive the     experimental therapy to two treatment plaque areas twice a week (2-5 days apart) for the     lesser of 12 weeks or until remission is observed in the treatment plaque areas. If remission     is observed in a treatment plaque area then treatment of that area will be discontinued and     the area assessed weekly. A third plaque area (control plaque area) will receive no drug or     light treatment and serve as an internal control.      Primary efficacy will be assessed 12 weeks after initial PH-10 treatment. Subjects will be     followed for a total of 16 weeks to allow assessment of Durability of Response of treated     lesions and comprehensive follow-up of adverse events.   "
206785|NCT00555659|"     Introduction: Degenerative changes of the discs and facet joints in the lumbar spine can     result in pain and disability from spondylosis, spondylolisthesis and stenosis. Patients who     are suffering with back and/or leg pain are potential candidates for an ALIF procedure.      Purpose: To assess and compare clinical outcomes and fusion rates in patients undergoing an     instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic     categories. Comparisons between type of interbody spacer, graft type, and type of     instrumentation will also be made   "
206786|NCT00555672|"     The purpose of this study is to determine the safe and tolerable dose of sunitinib when given     together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have     not received prior chemotherapy for their advanced cancer.   "
206787|NCT00555685|"     Patients with decompensated heart failure have high rates of mortality and morbidity despite     recent improvements in diagnosis and treatment. Some aspects of their presentation such as     renal failure, hyponatremia and congestive phenomena have received special attention, as they     are associated with worse prognosis. The infusion of hypertonic saline solution has been     tested in different conditions of cardiovascular collapse. Current evidence indicates that     the infusion of hypertonic solution in heart failure patients can provide clinical and     haemodynamic improvement. The investigators are testing the hypothesis that the infusion of     hypertonic solution in association with diuretics may prevent the occurrence of renal     dysfunction in patients with decompensated heart failure.   "
206788|NCT00555698|"     The purpose of this investigation is to obtain a preliminary indication of the feasibility,     safety and efficacy of capsular deep brain stimulation (DBS) as a treatment for intractable     depression. Also, to to learn about a new treatment for severe depression that has not     improved enough despite long-term treatment with medications and behavior therapy. The new     treatment is called deep brain stimulation, or DBS.      In DBS, thin wires are used to carry electric current to parts of the brain that are thought     to be involved in producing depression symptoms. Two wires are implanted surgically, and     attached to battery packs implanted under the skin of the new chest below your collar bone.   "
206789|NCT00555711|"     We have developed a safe, non-contact, intra-operative guidance system to optimize tumor     resection in neurosurgery. The Modulated Imaging is non-contact optical imaging technology     developed at the Beckman Laser Institute, UCI.      Compared to other imaging approaches, MI has the unique capability of performing both diffuse     optical tomography and rapid, wide-field quantitative mapping of tissue optical properties     within a single measurement platform.      Preliminary in vivo studies have shown that brain tumors, infiltrating tumor margins and     normal brain may have intrinsically different optical properties.   "
206790|NCT00555724|"     Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of     subjects with relapsed or refractory solid tumors.   "
206791|NCT00555737|"     The purpose of this study is to determine how well capsule endoscopy identifies changes in     the small bowel mucosa of celiac disease patients.   "
206796|NCT00555802|"     The purpose of this study was to evaluate the efficacy of motor control exercises. For this,     before and after motor control and general exercises, we determined transverses abdominis and     multifidus thickness, activity limitation and pain. We hypothesized that the motor control     exercises would increase transverses abdominis and multifidus muscles thickness. Activity     limitation and pain would decrease following two protocols that it was more in motor control     group than general one.   "
206797|NCT00555815|"     Surgical site infections are associated with high morbidity and cost Hypothesis: Extended     intraoperative hygiene measures decrease surgical site infections in general surgery compared     to standard hygiene measures.   "
206798|NCT00555828|"     Primary Objective The primary objective of this study is to evaluate the safety and     feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping     Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of 25 M, 75 M, and     150 M allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI.      SecondaryObjective      The secondary objectives are to explore functional efficacy for subsequent study design, as     well as late-term dose related tolerance, by:        -  Evaluating the effect of allogeneic MPCs on exploratory efficacy endpoints related to          cardiac function on Days 90, 180, and 1 year        -  Evaluating the change from baseline in the Medical Outcome Study Short Form (SF-36),          Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and the New York          Heart Association Classification at 30 days, 3 and 6 months, and 1, 2, and 3 years        -  Evaluating follow-up safety through Day 360        -  Providing preliminary data to support dose selection for future studies   "
206799|NCT00555841|"     The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of     non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant     radiotherapy.   "
206800|NCT00555854|"     Diabetes is a common condition associated with increased morbidity and mortality.     Non-pharmacological intervention strategies focusing on factors to improve self-management     skills are considered an important part of the treatment in individuals with diabetes.     Because of the increasing incidence in diabetes with costs (both physical, psychological and     financial) for both patients and society it is important to investigate interventions that     successfully promote self-care behaviour in patient with diabetes. Further research is needed     to develop interventions effective in maintaining long-term glycemic control.      The aim of this project is to study the long-term effect of a motivational intervention     program with an individual approach based on cognitive-behavioural strategies in chronically     ill patients with diabetes. The effect will be evaluated on both physiological and     psychosocial parameters including patient's experienced self-care competence.      The study will also provide an overview of what kind of non-pharmacological interventions     that have been applied in relation to the treatment of type 2 diabetes and assess the effect     of the various non-pharmacological interventions in randomised controlled trials.   "
206801|NCT00555867|"     Approximately 60 specialised clinics and 420 office based gynaecologists or oncologists will     participate in this in practice evaluation program (NIS). The clinic and approximately 7     office based physicians will collaborate within their breast centre networks to conduct this     program. A breast centre network should be able to recruit in this program approximately 80     patients (approximately 40 patients per year). It is planned to enroll approximately 4674     patients in this NIS (2337 patients per arm). The patient population will include     postmenopausal women with hormone-receptor positive primary breast cancer scheduled for     upfront adjuvant endocrine treatment with anastrozole according to the current standard     medical procedures.   "
206802|NCT00555880|"     The purpose of this clinical study is to evaluate the clinical effect of midodrine     hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by     measuring the time to onset of near syncopal symptoms and assessing several cardiovascular     measurements, such as heart rate, blood pressure, and ECG, using the tilt table test.   "
206803|NCT00555893|"     This study is a randomized, blinded, placebo-controlled clinical efficacy trial to assess the     duration and severity of influenza symptoms, and duration of viral shedding, in influenza     patients receiving oseltamivir early and late relative to placebo.      There are two main hypotheses in this study:        1. The duration of influenza symptoms, mean severity score, and duration of viral shedding          are reduced in patients who initiate oseltamivir treatment late (48 to 119 hours)          compared to those receiving no antiviral therapy.        2. Prior influenza vaccination (same season) reduces the duration of influenza symptoms and          mean symptom severity in patients receiving oseltamivir after adjusting for age and          timing of antiviral therapy (early versus late).      There are two secondary hypotheses:        1. The duration of influenza symptoms, mean severity score, and duration of viral shedding          are reduced in patients with influenza who initiate oseltamivir treatment early (< 48          hours) versus late (48 to 119 hours).        2. The incidence of secondary complications is lower in patients initiating oseltamivir          therapy late relative to those receiving no antiviral therapy.   "
206804|NCT00555906|"     This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in     combination with Velcade® [bortezomib] and dexamethasone in patients who have received at     least one previous treatment for multiple myeloma.   "
206805|NCT00555919|"     Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211     (100 mg vs. 25 mg) as second-line endocrine therapy for postmenopausal women with hormone     receptor-positive metastatic breast cancer.Once the cancer has spread beyond the lymph nodes     to areas such as e.g. the skin, soft tissues, lung, and liver it is called metastatic breast     cancer. Patients who have been diagnosed with metastatic breast cancer that has progressed     since their previous cancer treatment and that cannot be removed completely by surgery are     eligible to be treated within this trial.Treatment with a new drug called Progesterone     Receptor Antagonist ZK 230211 (ZK PRA) targets the progesterone receptor which may be     expressed on breast cancer tumour cells. Therefore only patients with this progesterone     receptor on their tumour cells can be included in this study.Progesterone receptor     antagonists (including onapristone) have already shown efficacy in postmenopausal women with     advanced breast cancer (Klijn et al. 2000). This phase II study investigates the efficacy     (proof of concept), safety and tolerability of ZK PRA at two dose levels (25 mg and 100 mg)     before initiating pivotal phase III trials.   "
248532|NCT01108523|"     This study evaluates HP828 in the management of moisture associated skin damage after 15 days     of use.   "
206807|NCT00555945|"     The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus     sliding hip screws on rate of revision surgery in individuals with inter-trochanteric     fractures. Secondary outcomes include fracture healing rates, fracture related complications,     and health-related quality of life.   "
206808|NCT00555958|"     To determine the safety, efficacy and treatment algorithm(s) of the Maestro System in causing     weight loss in obese subjects - This study will provide feasibility data regarding the     potential of intra-abdominal vagus nerve down-regulation/block in the treatment of obesity.   "
206809|NCT00555971|"     This is a 24 week double-blind study in which subjects will be randomized 2:1 to receive     Xolair (Omalizumab) or placebo. 14 subjects will receive Xolair and 7 will receive placebo.     Xolair injections will occur every 2-4 weeks. Aspirin desensitization will occur several     weeks later. One month after desensitization, the final visit will occur in the GCRC.      We hypothesize that administration of Xolair, a monoclonal anti-IgE antibody, prior to the     aspirin desensitization will reduce severity of aspirin-induced reaction.   "
206810|NCT00555984|"     If the anesthetic regimen can influence the serum level of inflammatory cytokines and if the     levels of cytokines are related to the incidence of post operative complications, these     complications may be a function of the anesthetic method. In an effort to find the best     anesthetic regimen for patients undergoing craniotomy for intracranial tumors, the     researchers will compare the effect of volatile anesthetic with that of total intravenous     anesthesia (TIVA) on cytokine levels. The researchers will also compare the composite     incidence of some common major post-operative complications after craniotomy for intracranial     malignancy.   "
206811|NCT00555997|"     This is a study on the effectiveness, tolerability and safety of oral ziprasidone as     monotherapy in patients with major depressive disorder (MDD). Outpatients suffering from MDD     will be treated with either ziprasidone or placebo for 12 weeks.      Hypothesis: There will be a statistically significant difference in the magnitude of     response, as measured by a decrease in baseline 17-item Hamilton Depression Rating Scale     (HAM-D-17) scores, between the two treatment groups; the reduction in HAM-D-17 scores will be     greater in the ziprasidone monotherapy group than in the placebo group.   "
206812|NCT00556010|"     Ankle fractures are common injuries that are being operated routinely. In order to restore     the long term function and prevent arthritis of the ankle the broken fragments should be put     in place precisely. Inadequate reduction can result in pain and long term disability.     Recently, based on MRI studies and clinical studies, a significant number of ankle fractures     are apparently fixed with less than optimal results. We suggest that the use of a new device     that enables better three dimensional imaging will improve the quality of operations     performed for ankle fractures.   "
206813|NCT00556023|"     The purpose of this study is to determine the safety and tolerability of different doses of     CP-675,206 in combination with gemcitabine and to determine the maximum dose of CP-675,206     that is well tolerated when given in combination with gemcitabine to patients with advanced     pancreatic cancer.   "
206814|NCT00556036|"     The purpose of this study is to determine whether the hormone dynamics in women with anorexia     nervosa and hypothalamic amenorrhea is related to bone loss in those populations.   "
206815|NCT00556049|"     The purpose of this research study is to determine if the combination of sunitinib and     gemcitabine is effective in treating patients with metastatic renal cell carcinoma. The     safety of this combination will also be studied. Sunitinib is approved by the FDA for the     treatment of renal cell carcinoma. However, some patients' cancers do not respond to     treatment or stops responding after initially responding. Gemcitabine is a chemotherapy drug     that is approved by the FDA for the treatment of pancreatic cancer and several other cancers.     It is not approved for the treatment of renal cell carcinoma. Previous research has suggested     that combining gemcitabine with sunitinib may have some effectiveness in treating metastatic     renal cell carcinoma.   "
206816|NCT00556062|"     To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split     influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial     was conducted in 560 subjects in Tianjin City of China.   "
206817|NCT00556075|"     The purpose of this study is to determine whether Proellex is safe and effective for the     treatment of symptomatic endometriosis.   "
206818|NCT00556088|"     This phase I protocol will evaluate the safety and tolerability of the combination of LBH589     and paclitaxel/carboplatin. The combination of LBH589, paclitaxel/carboplatin, and     bevacizumab will also be evaluated for tolerability and preliminary antitumor activity in a     subset of patients with advanced non-small cell lung cancer.   "
206819|NCT00556101|"     Investigation of how the patients experience whole body MRA. After the WB-MRA the patients     will fill in a questionnaire, that contains questions about the WB-MRA procedure and how the     patient felt during the examination.      We expect that the patients will report a high degree of satisfaction with the WB-MRA     procedure, with little discomfort.   "
206820|NCT00556114|"     Growing evidence shows that altered blood flow plays a major role in many vision-threatening     diseases including glaucoma, diabetic retinopathy, age-related macular degeneration, Central     Retinal Vein Occlusion, and Branch Retinal Vein Occlusion. Optical coherence tomography, an     established imaging technique use for eye exam in clinical ophthalmology, provides     high-resolution cross sectional images of the retina and has increased our ability to     understand many eye diseases.   "
206821|NCT00556127|"     The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to     dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT)     as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI     score   "
206822|NCT00556140|"     The purpose of the study is to assess the safety and effectiveness of the combination of     aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with     psychotic major depression.   "
206823|NCT00548990|"     The purpose of the study is to examine whether cardiovascular exercise training improves     immune responses to vaccination in previously sedentary older adults.   "
206824|NCT00549003|"     The purpose of this study is to assess performance and cost-effectiveness of rapid diagnostic     test(RDT) aided malaria diagnosis versus symptom-based/clinical diagnosis in patients of all     ages with reported fever last 48 hours alone in primary health care settings in Zanzibar.   "
206825|NCT00549016|"     The ultimate purpose is to explore the potential techniques to exclude aneurysms and provide     an alternative conduit for arterial flow. The single center sponsorship is intended to     provide the investigators the potential to incorporate improvements in existing technology     during the course of the study thereby ultimately enhancing the potential for superior     medical care of patients suffering from these disease states. The sponsor/investigator     recognizes and accepts responsibility to notify and receive approval from the agency when     device modifications are made that may affect patient safety.   "
206826|NCT00549029|"     To observe not only the distribution of single nucleotide polymorphism in genes related with     pharmacodynamic and pharmacokinetics alteration of statins but also to analyze the     correlation between these SNPs and the incidence of statins-induced myopathy.   "
206827|NCT00549042|"     This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl), a     once daily opioid analgesic that can relieve pain. A large number of clinical studies have     been conducted to test this drug. NMED-1077 is still being tested and is not approved by the     Food and Drug Administration (FDA) for sale in the United States. OROS® hydromorphone HCl is     currently approved in Europe to treat chronic pain.      The purpose of this study is to compare NMED-1077 to placebo to see if NMED-1077 is safe and     efficacious.   "
206828|NCT00549055|"     To assess effectiveness of Macugen for treatment of neovascular age-related macular     degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of     administration and combination with other treatments will also be evaluated.   "
206829|NCT00549068|"     To compare the subject satisfaction rating in women treated for postmenopausal osteoporosis     with Actonel 35mg Once-a-Week for 24 weeks, and receiving feedback information, after 12     weeks of treatment, based on bone resorption marker results using the NTx Point-Of-Care (POC)     device, to similar women treated as per regular clinical practice   "
206830|NCT00549081|"     Approximately 10% of all couples will be diagnosed as infertile. The most efficient     infertility treatment is In-Vitro Fertilization (IVF). One major determinant for success is     production of an adequate number of oocytes (eggs) from the female in order to finally have     good-quality embryos and finally acceptable pregnancy and delivery rates. Some women will not     respond adequately to hormonal stimulation and will only a small number of oocytes.     Therefore, the chances of finally having a successful delivery are significantly reduced.     Although the specific definition of this situation is controversial, these patients are     diagnosed as having low ovarian response. This condition is more prevalent in older IVF     patients as part of the reproductive aging process; it is possible at any age. Currently, the     understanding of low ovarian response is limited, and although many therapeutic approaches     have been suggested, no treatment has been proven significantly efficient.      DHEA is a pro-hormone produced by the adrenal gland and the ovary. DHEA serum levels become     lower with age and in some chronic diseases. Therefore, some believe it may be beneficial as     an 'anti-aging' factor. DHEA pills are available as a food-supplement, without need for     prescription in the US.      DHEA is involved in the regulation of follicular growth in the ovaries. In a 2000 report,     five IVF patients who had low ovarian response were treated with oral DHEA (Casson et al, Hum     Reprod 2000;15:2129). A small increase in the ovarian response to hormonal stimulation was     noticed. Barad and Gleicher reported their relatively extensive experience, summarizing     treatment outcome in 25 IVF low-responders treated with oral DHEA pills (Barad and Gleicher,     Hum Reprod 2006; 21, 2845). They observed increased increases in fertilized oocytes, normal     day 3 embryos, and number of embryos transferred after DHEA treatment compared with a     previous treatment outcome before DHEA.      Based on this observation, DHEA may appear useful for improving IVF outcome in some patients.     However, a prospective randomized study on DHEA supplementation for IVF patients was not yet     published. Our aim is to conduct such a study, focusing on IVF patient with low ovarian     response.   "
206831|NCT00549107|"     Pediatric patients, especially infants undergoing open heart surgery have a predictable fall     in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome     (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in     intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely     used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves     cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow     through calcium sensitization of the myocardial contractile filaments and opening of     potassium channels without increasing oxygen consumption of the heart muscle cells. As the     myocardium of infants is more calcium dependent than in later life, levosimendan should be of     special benefit in this age group. The purpose of this study is to investigate whether     levosimendan is superior to milrinone in preventing LCOS in infants after corrective open     heart surgery.   "
206832|NCT00556153|"     The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in     pediatric brain tumors when compared to normal brain tissue.   "
206833|NCT00556166|"     Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of     patients with long term, uncontrolled (not helped by medication) nausea and vomiting from     gastroparesis of diabetic or idiopathic origin.      In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device     Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical     (GES) Simulation System. Although, there is evidence that suggests the use of Enterra Therapy     System probably helps patients, symptoms, the FDA's HDE approval indicates that the     helpfulness of this therapy has not been proven. Physicians at Columbia University Medical     Center hope to prove the helpfulness of this device.   "
206834|NCT00556179|"     The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence     of bacterial vaginosis after three months of the standard treatment.   "
206835|NCT00556192|"     This prospective randomized control trial is undertaken to evaluate the safety and efficacy     of anti-CD20 monoclonal antibody, rituximab, used as 1. monotherapy, 2. in combination with     cyclophosphamide, in the treatment of proliferative lupus nephritis, as compared with     standard immunosuppressive therapy with cyclophosphamide and azathioprine.   "
206836|NCT00556205|"     The purpose of this research study is to further define an effective strategy for people with     renal cell carcinoma and to learn the safety and effectiveness of two different types of     sunitinib-refractory treatments: Bevacizumab alone or a combination of sunitinib and     bevacizumab. Sunitinib is an FDA approved drug and is currently one of the standard     treatments for advanced renal cell carcinoma. However, some people who receive this treatment     do not respond to treatment or they stop responding to treatment. Bevacizumab is an FDA     approved drug used for the treatment of several cancers however, is not yet approved for use     in renal cell carcinoma.   "
206837|NCT00556218|"     The goal of this behavioral research study is to learn if participating in a Tibetan     meditation program helps to improve quality of life for women after chemotherapy and during     recovery from breast cancer. Whether the meditation program helps to improve brain function     and sleep quality will also be studied.   "
206838|NCT00556231|"     Near Infrared Spectroscopy (NIRS) monitoring has proven beneficial in increasing safety and     improving patient care during pediatric cardiac surgery and during Pediatric Intensive Care     Unit (PICU) stays. NIRS estimates the amount of oxygen in tissues by comparing the tissue's     absorption of two wavelengths of light corresponding to hemoglobin carrying oxygen and     hemoglobin without oxygen.      During cardiac surgery, multi-site NIRS monitoring is used to determine the heart's output by     comparing the amount of oxygen available to discrete regions of the body nourished by     different parts of the circulatory system. NIRS leads placed on the forehead detect oxygen     available to the brain (cerebral), while leads placed over the kidney reflect oxygen     available to the internal organs (somatic).      NIRS monitoring has been used for studying muscle oxygen usage during exercise in normal and     disease states. Cerebral oxygenation at peak exercise at has been studied with NIRS     monitoring. The use of multi-site NIRS monitoring during exercise stress testing for studying     cardiac output through the patterning of somatic and cerebral oxygenation in combination with     exercise stress test data has not been researched.      We hypothesize that addition of multi-site NIRS monitoring to the standard data collection     already achieved during exercise testing, will enable calculation of anaerobic threshold and     cardiac output prediction. This will assist in determining appropriate timing for surgical     intervention, predicting the post operative course and testing response to medication.   "
206839|NCT00556244|"     Internal limiting membrane peeling in diabetic vitrectomy will help prevent postoperative     epiretinal membrane formation   "
206840|NCT00556257|"     A new immunosuppressive drug based on the inhibition of an important enzyme in the immune     system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this     research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant     patients for 12 months in addition to other standard transplant medications such as     prednisone.   "
206841|NCT00556270|"     The aim of the study is to evaluate the efficacy and safety of matrifen in patients with     severe and chronic pain who can only be sufficiently treated with opioid analgesics (WHO     class 3).   "
206842|NCT00556283|"     This study aimed to evaluate the safety and symptomatic outcomes achieved with Stapled     Transanal Rectal Resection (STARR) compared to biofeedback training in patients with     obstructed defecation syndrome (ODS).   "
206843|NCT00556296|"     This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose     of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with     ADHD.   "
206844|NCT00556309|"     The purpose of this study is to identify the healing of aneurysms in three month use Optical     Coherence Tomography image to measure outcomes in post coiled aneurysms. Endovascular     therapeutic coiling is a widely used procedure in the management of aneurysms, which is an     angiogram .   "
206845|NCT00556322|"     This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that     of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC     experiencing disease progression after failure of platinum-based chemotherapy.Eligible     patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either     Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on     study treatment is until disease progression ,and the target sample size is 500+ individuals.   "
206846|NCT00556335|"     The purpose of this study is to evaluate the efficacy of manual aspiration in comparison to     conventional chest tube drainage in pneumothorax therapy:        1. whether manual aspiration will shorten hospital admission.        2. whether the lung will expand by means of clinical and radiological findings.   "
206847|NCT00556348|"     To report the short term anatomic and visual acuity response after intravitreal injection of     bevacizumab (Avastin, Roche, Rio de Janeiro, Brazil) in patients with choroidal     neovascularization secondary to age-related macular degeneration.   "
206848|NCT00556361|"     To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury     to the cells in the brain.   "
206849|NCT00556374|"     The purpose of this study is to determine whether denosumab compared to placebo, will reduce     the rate of first clinical fracture in women with non-metastatic breast cancer receiving     (non-steroidal) aromatase inhibitor therapy.      Subjects who receive open-label denosumab will be followed-up until completion of 36 months     of treatment. Subject not receiving treatment in the open label phase will be followed for     approximately 66 months after Primary analysis data cut-off date (PADCD).   "
206850|NCT00556387|"     The purpose of this study is to determine the possible effects of an anesthetic agent called     Ketamine on the injured brain in children.      The researchers think that it will effect the outcomes of children with these injuries.   "
206851|NCT00556400|"     This study will explore the role of oral contraceptive pills in managing uterine bleeding in     women who have low blood platelet counts as a result of aplastic anemia. Oral contraceptive     pills have been shown to be effective in managing uterine bleeding in healthy women, but the     effects have not been thoroughly studied in women who have low platelet counts. The purpose     of the study is to determine whether oral contraceptive pills are a useful complement to     platelet transfusions in women with aplastic anemia and uterine bleeding.      Volunteers for this study must be women between 12 and 55 years of age who have been     diagnosed with aplastic anemia (with a platelet count of less than 50,000/microliter) and     currently have active uterine bleeding. Candidates must not be pregnant or breastfeeding,     must have a uterus and at least one functioning ovary, and must be willing to use nonhormonal     methods of birth control (such as condoms or a diaphragm) for the duration of the study. On     the first visit, candidates will be screened with a complete medical history (including     obstetric and gynecological history) and will undergo a physical examination, a pelvic exam     and a pelvic ultrasound. Blood and urine samples will also be taken on this first visit.      The study will last approximately two weeks. Participants will be asked to monitor their     medication doses and severity of bleeding during the course of the study. After the first     visit, participants will be separated into two randomized groups and will receive either one     tablet of oral contraceptive or a placebo twice daily, to be taken 12 hours apart at the same     times each day. Participants will also receive platelet transfusions as needed to ensure that     their platelet counts remain over 20,000/microliter. After seven days, researchers will     assess participants' uterine bleeding and all participants will be given oral contraceptives     in the second week of the study. Participants whose bleeding has decreased will receive only     one tablet; participants who still have moderate to severe uterine bleeding will receive two     tablets. A final assessment will be performed on day 14 of the study.   "
206852|NCT00556413|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving cetuximab together with combination chemotherapy may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination     chemotherapy works as first-line therapy in treating patients with metastatic colorectal     cancer.   "
206854|NCT00556439|"     Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause swelling of     the arteries in the head, neck, upper body, and arms. TAK specifically affects the aorta, the     largest blood vessel in the body, and its branches. Therapies are available to improve the     symptoms of GCA and TAK, but relapse often occurs, and better treatments are needed.     Abatacept is a drug that interacts with certain cells in the body that are involved with GCA     and TAK. This study will evaluate the effectiveness of abatacept in treating GCA and TAK and     preventing disease relapse.   "
206855|NCT00556452|"     The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with     Busulfan as a full-intensity conditioning (Clo/BU4 regimen) prior to transplant and then     (Phase II) to investigate the safety and effectiveness of this regimen as a conditioning for     stem cell transplant in the treatment of aggressive hematologic malignancies in subjects     where more conventional approaches are failing.   "
206856|NCT00556465|"     Diabetic nephropathy has become the single most frequent cause of end-stage renal disease.      On a molecular level, at least five major pathways have been implicated in glucose-mediated     vascular and renal damage and all of these could reflect a single hyperglycaemia-induced     process of overproduction of reactive oxygen species.      Recent studies have shown that inflammation, and more specifically pro-inflammatory cytokines     play a determinant role in the development of micro- vascular diabetic complications, most of     the attention has been focused on the implications of TNF-α in the setting of diabetic     nephropathy.      Glutathione is the most abundant low-molecular-weight thiol, and Glutathione/ glutathione     disulfide is the major redox couple in animal cells.      N-acetylcysteine is effective precursors of cysteine for tissue Glutathione synthesis.      Not only does N-acetylcysteine exhibit antioxidant properties, but it may also counteract the     glycation cascade through the inhibition of oxidation.      N-acetylcysteine can also reduce the apoptosis elicited by reactive oxygen species .      Indeed, N-acetylcysteine has been shown to inhibit reactive oxygen species induced mesangial     apoptosis and to be able to protect cells from glucose-induced inhibition of proliferation.   "
206857|NCT00556478|"     The purpose of this study is to evaluate the effectiveness, safety and tolerability of the     investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug,     PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic     (numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be     applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an     attempt to delay ejaculation.   "
206858|NCT00559468|"     The objective of the trial was to show equivalence in recovery from neuromuscular block after     a single dose of 4.0 mg.kg-1 Org 25969, administered at T1 3-10% after continuous infusion of     rocuronium, between subjects receiving maintenance anesthesia using propofol and subjects     receiving sevoflurane, to investigate the safety and to compare the plasma levels of     rocuronium in subjects after continuous infusion of rocuronium and before the administration     of Org 25969, under either propofol or sevoflurane anesthesia.   "
206859|NCT00559481|"     RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving     ketoconazole together with dexamethasone and hydrocortisone may help doctors learn more about     how these drugs are used by the body.      PURPOSE: This randomized clinical trial is studying how ketoconazole, dexamethasone, and     hydrocortisone act in the body of patients with prostate cancer that did not respond to     androgen-deprivation therapy.   "
206860|NCT00559494|"     While research in animal models of spinal cord injury have provided many promising insights,     human studies have failed to produce effective therapies. We propose to investigate the drug     Minocycline (a metalloproteinase inhibitor) for the treatment of spinal cord injured patients     aiming to limit neurological injury and improve neurological outcome. This drug influences     several secondary injury mechanisms implicated in spinal cord injury and has been effective     in improving outcome after spinal cord injury in animal models. We also propose to examine     the safety and feasibility of spinal cord perfusion pressure augmentation with a protocol of     IV fluids and inotrope medications versus standard maintenance of mean arterial pressure in     subjects who exhibit a decrease in perfusion pressure to less than 75 mmHg. The purpose of     this pilot study is 1) to evaluate the feasibility of a clinical trial protocol for     Minocycline in patients with acute spinal cord injury, and 2) to ensure adequate drug dosing     and metabolic effect. After undergoing a process of informed consent, patients agreeing to     participate in the study will be randomized to placebo or treatment groups in a double-blind     fashion. Clinical neurological examinations, patient-reported quality of life, and functional     independence categorization will be combined with serum and cerebrospinal fluid laboratory     investigations to establish some of the pharmacological properties and the safety profile of     this medication in this group of patients. In addition, patient tolerance to the dosing     regimen will be assessed. The results of this study will provide the preliminary data     necessary to plan for a larger prospective, randomized, controlled, double-blind clinical     trial to assess efficacy and to further assess safety.   "
206861|NCT00559507|"     This phase II trial is studying saracatinib to see how well it works in treating patients     with metastatic or locally advanced breast cancer that cannot be removed by surgery.     Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth   "
206862|NCT00559520|"     The role of preoperative oral immunonutrition in major vascular surgery.      The mean purpose of this study was to determine the prevalence of post-operative infection     complications after major vascular surgery in group of patients with preoperative oral     immunonutrition.      This group was compared to a control group.      Secondary purpose was to evaluate the effect of preoperative oral immunonutrition on     postoperative mortality (30 days), the medium length of stay in the hospital and the cost of     treatment in the two groups   "
206863|NCT00559533|"     This study will determine the maximum tolerated dose and the optimal associated 4 weekly     dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid     tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily     for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose     escalations, and possible changes in dosing schedule, based on tolerability and     pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study     treatment is until disease progression or intolerable toxicity.   "
206864|NCT00559546|"     The purpose of the study is to find out if montelukast can be used to treat the various     symptoms of allergic syndrome.   "
206865|NCT00559559|"     This study is intended to look at the effect of the SJM vibrating Patient Notifier™ system,     which will warn the patient of possible failures of the implanted system, on reducing patient     device related anxiety   "
206866|NCT00559572|"     This study will evaluate the impact of motivational guidance to exercise on people with     schizophrenia, based on their participation in a walking program.   "
206867|NCT00559585|"     The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept     yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in     participants with rheumatoid arthritis and an inadequate response to current methotrexate     therapy.   "
206868|NCT00559598|"     RATIONALE: Studying samples of blood in the laboratory from patients with cancer and from     healthy participants may help doctors identify and learn more about proteins related to     cancer. It may also help doctors tell whether a patient has cancer.      PURPOSE: This clinical trial is looking at proteins in blood samples to see how well they     work in finding pancreatic cancer and extrahepatic biliary tract cancer.   "
206869|NCT00559611|"     The goal of this clinical research study is to compare 2 different methods for checking lymph     glands (in the middle of the chest) for cancer cells.      Objectives:      The aim of this prospective study is to determine the staging accuracy of endobronchial     ultrasound guided fine needle aspiration biopsy of mediastinal lymph nodes compared to the     'gold standard', mediastinoscopy, in patients with clinical Stage IIIA non-small cell lung     cancer.      Primary Objective:      To determine the sensitivity, specificity, positive predictive value, negative predictive     value, and accuracy of EBUS-FNA and mediastinoscopy in identifying mediastinal nodal     metastases.      Secondary Objectives:      To estimate quantitative and qualitative differences regarding sampling of mediastinal nodes     (number and location of nodes biopsied, number and location of positive nodes, extracapsular     extension, ability to biopsy contralateral nodes).      To determine the frequency of change of planned therapeutic management resulting from outcome     of EBUS-FNA and mediastinoscopy.      To determine procedure related complications. To perform analysis of cost between EBUS-FNA     and mediastinoscopy.   "
206870|NCT00559624|"     The main aim of this study is to test the safety of acadesine in patients with B-CLL and see     what effects it has on patients and their leukaemia. The study also aims to examine the way     acadesine is processed by the body. The study will look at the effects of acadesine in the     body and the concentration of the drug and its main by-product (ZMP) in the blood to     determine the dose and the frequency of dosing that is likely to be the most effective.   "
206871|NCT00559637|"     This single arm study will assess the efficacy and safety of subcutaneous Mircera for     correction of anemia in participants with chronic kidney disease who are not treated with     erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will     receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight,     will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11     months, and the target sample size is 100-500 individuals.   "
206872|NCT00559650|"     The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667)     given intravenously, to evaluate if this is safe and can help to improve the well-being,     symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with     chronic heart failure have a risk of increased number of hospitalisations because of     worsening of their condition (decompensated heart failure). The current treatment of acute     heart failure consists of oxygen and medical treatment with vasodilators and positive     inotropic agents (drugs, which should strengthen the pump function of the heart) which have     their limitations. Therefore there is a need for new drugs in treatment of acute heat     failure.   "
206873|NCT00559663|"     The purpose of this study is to compare the effect of dark chocolate with green tea in     healthy subjects on clot formation (platelet activity) cholesterol profile and markers of     inflammation in two groups.      The first group will be on a regimen of dark chocolate, and the second group will be on a     regimen of green tea. Clinical outcomes will be determined after seven days of each treatment     and both groups will undergo both treatments subsequently and serve as their own control.      The hypothesis is that both green tea and dark chocolate will reduce platelet activity and     reduce LDL, hsCRP and increase HDL.   "
206874|NCT00559676|"     RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with     cancer receiving chemotherapy may help doctors understand the effect of chemotherapy on     biomarkers. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This phase IV trial is studying biomarkers in patients undergoing chemotherapy for     metastatic colorectal cancer.   "
206875|NCT00559689|"     Once-daily inhaled glucocorticosteroids treatment can sufficiently control airway     inflammation in asthma patients.   "
206876|NCT00559702|"     The primary objective of this study is to compare the pharmacokinetic (PK) and     pharmacodynamics (PD) of single subcutaneous (SC) and intramuscular (IM) doses of 300 mg     natalizumab to intravenous (IV) administration of 300 mg natalizumab in multiple sclerosis     (MS) participants. The secondary objectives are to investigate the safety, tolerability and     PK of repeated natalizumab doses administered SC and IM, to investigate the immunogenicity of     repeated natalizumab doses administered SC and IM, to explore proof of concept within the     secondary progressive multiple sclerosis (SPMS) population using change from baseline in     clinical measures including: expanded disability status scale (EDSS), multiple sclerosis     functional composite scale (MSFC), symbol digit modalities test (SDMT), visual analogue scale     (VAS), and visual function test; and brain magnetic resonance imaging (MRI) measures     including: number of new or newly-enlarging T2 hyperintense lesions, number of new T1     hypointense lesions, number of new gadolinium-enhancing (Gd+) lesions, whole brain atrophy,     magnetization transfer ratio (MTR), and diffusion tensor imaging (DTI) and to observe the     effect of natalizumab administered IV and SC on brain MRI measures in participants with     relapsing forms of MS.   "
206877|NCT00559715|"     The study is designed to demonstrate the therapeutic non-inferiority of the recombinant     humanized monoclonal VEGF antibody bevacizumab administered by intravitreal injection in the     treatment of AMD in comparison to the related fragment ranibizumab.   "
206878|NCT00559728|"     The purpose of this study is to analyze atherosclerotic vessel wall components with     multidetector computed tomography (MDCT) and compare with MRI. The hypothesis is that MRI is     comparable to computed tomography (CT) in showing plaque components of coronary plaques.   "
206879|NCT00559741|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving cetuximab     together with combination chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination     chemotherapy works in treating patients with advanced or metastatic colorectal cancer.   "
206880|NCT00559754|"     This single arm study will assess the efficacy and safety of a combination of Avastin and     docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable     breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin     (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each     cycle). They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each     cycle) in combination with Avastin (15mg/kg on day 1 of each cycle). The anticipated time on     study treatment is 3-12 months, and the target sample size is <100 individuals.   "
206881|NCT00559767|"     This study will identify which regions on the genes, and genes themselves, may account for an     increased risk of end stage renal disease (ESRD), that is, near-total loss of kidney     function, for people of African American descent. Researchers will use a technique called     admixture linkage disequilibrium (MALD) to study genomes, genetic material, in about 2,500     participants from two existing studies and participants who will serve as controls. ESRD     disproportionately affects African Americans, who constitute 29% of all ESRD patients in the     Medicare ESRD program. The disease can result from a variety of diseases, with diabetes as     the leading underlying cause (44% of cases) and hypertension as the second leading cause     (26%). The proportion of ESRD cases caused by diabetes has increased dramatically.      Patients age 18 and older who are African American, who have ESRD, and who are participants     of the FIND and CHOICE studies may be eligible for this study. FIND, or Family Investigation     of Diabetes and Nephropathy, involves a multicenter study to identify susceptibility genes,     that is, those with a risk, for diabetic and other forms of kidney disease. CHOICE, or     Choices for Healthy Outcomes in Caring for ESRD patients is an ongoing study that identifies     risk factors for cardiovascular outcomes in ESRD patients. The principle of mapping by MALD     involves genetic variations that exist across populations. When mixing occurs between     populations having different (heterogeneous) genes, the admixed offspring inherits     chromosomes of distinct ancestry. However, over generations of mating, and recombination over     several generations, originally large blocks of DNA from African ancestry have become part of     smaller segments throughout the chromosome. The study will focus on risk alleles, that is,     alternative forms of genes that carry a disease risk. Risk alleles are closely related to     nearby ancestral gene markers found in a person.      Patients will undergo a collection of blood and urine for genetic testing. Researchers are     conducting separate analyses in this study. Case-control analysis of ESRD will consist of     1,150 participants from FIND and 250 from CHOICE. There will also be 750 control participants     from FIND. For the case-control analysis of diabetic ESRD, there will be about 750     participants from FIND, 125 from CHOICE, and 750 controls from FIND. Finally, there is the     quantitative trait analysis, which looks at the phenotype-meaning visible characteristics     produced by the interaction of a person's genetic makeup with the environment. That analysis     will involve 350 patients with diabetic nephropathy but not ESRD and 750 controls from FIND.   "
206882|NCT00559780|"     During the last decades there has been an increase in the relative proportion and life     expectancy of elderly people in the industrialised countries. Consequently the amount of     elderly with diseases and disabilities related to aging has increased. It therefore appears     paramount to gain a better understanding of how disuse and immobilisation affects     neuromuscular properties in the elderly, as well as to identify training regimes that ensures     an effective rehabilitation.The population of interest in the present study was elderly     individuals with long term hip-osteoarthritis undergoing a hip-replacement operation. The     study was divided in two parts, a cross-sectional study and an intervention study.      The cross-sectional study investigated muscle size, maximal muscle strength, specific force,     neural drive and explosive muscle force characteristics in elderly individuals who were     affected by unilateral prolonged disuse due to hip-osteoarthritis. The data clearly indicated     that the side with hip-osteoarthritis was affected by a marked decrease in muscle mass,     maximal muscle strength, neural drive and explosive muscle force characteristics compared to     the unaffected side.      The intervention study investigated if elderly patients that undergo hip-replacement surgery     could benefit from additional training in the early postoperative phase. The data clearly     demonstrated that resistance training was an effective and safe way to increase muscle mass,     maximal muscle strength, neuromuscular activity, functional performance and decrease the     hospitalisation period compared to regimes of conventional rehabilitation regimen or     electrical muscle stimulation. Additionally the intervention study demonstrated that     resistance training effectively induced marked increases in explosive muscle force     characteristics in elderly subjects compared to rehabilitation regimes using electrical     muscle stimulation or conventional rehabilitation. Furthermore, the gains in maximal muscle     strength and explosive muscle force characteristics were accompanied by significant increases     in EMG amplitudes. Furthermore, the demonstration that explosive muscle force capacity of the     neuromuscular system remains trainable in elderly recovering from prolonged limb disuse and     major surgery may have important implications for future rehabilitation programs, especially     when considering the importance of rapid muscle force capacity on postural balance, maximal     walking speed and other tasks of daily life actions.   "
206883|NCT00559806|"     The debilitating effects of immobilisation on muscle strength and size in young individuals     are well documented. Moreover, sarcopenia has long been recognized as a major cause of muscle     strength loss in old age, however, changes in muscle mass and architecture with     immobilisation in the elderly has not previously been investigated. This is contrasted by the     fact that the elderly population more often undergoes periods of immobilization and disuse     not only due to joint pain but also due to a higher degree of co morbidity and     hospitalisation.The purpose of the present study was to compare the effect of a 2 week period     of unilateral immobilisation on the physiological muscle cross sectional area, maximal     isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation     angle in young and old healthy men.   "
206884|NCT00559819|"     The proposed study will validate and determine sensitivity of our new driving simulator,     created to evaluate driving ability in a related study to show similar driving performance     between patients on chronic opioid treatment and a control group. Although the commercial     version of the simulator has been validated for certain populations and certain measures,     these require re-calibration for our own clinical study. The investigators propose a     prospective randomized clinical trial to evaluate driving skills under alcohol consumption     using a driving simulator. Two groups of study subjects will be utilized, with the majority     (80%) receiving alcohol and placebo at different times. A smaller set of study subjects (20%)     will be given placebo on both trials to evaluate learning effects and placebo blinding     effectiveness. Each group will take the driving test at three time points: once as a baseline     at the beginning of the study, once after the 1st dosing of the placebo and again after     dosing two of the alcohol or placebo beverage. This information will allow us to evaluate     driving ability under other potentially impairing conditions such as opioid usage.   "
206885|NCT00559832|"     Acclimatization by mountaineering prior to high altitude sojourns have shown to be effective     in prevention of acute mountain sickness (AMS).      The aim of this study is to investigate whether intermittent exposure to normobaric hypoxia     during sleep is also effective to prevent AMS.   "
206886|NCT00559845|"     This single arm study will assess the efficacy and safety of sequential neoadjuvant     chemotherapy and Avastin, before surgery and/or radiotherapy, in patients with inflammatory     or locally advanced operable breast cancer. Patients will receive FEC, followed by     paclitaxel, given concomitantly with Avastin (10mg/kg i.v. every 2 weeks). The anticipated     time on study treatment is 3-12 months, and the target sample size is <100 individuals.   "
206887|NCT00559858|"     RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by     chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in     preventing hand-foot syndrome.      PURPOSE: This phase III randomized trial is studying pyridoxine to see how well it works     compared to a placebo in preventing hand-foot syndrome in patients who are receiving     capecitabine for advanced colorectal cancer or breast cancer.   "
206888|NCT00559871|"     The purpose of this study is to determine whether Fipamezole is effective in the treatment of     levodopa-induced dyskinesia in advanced Parkinson's disease.   "
206889|NCT00559884|"     The purpose of this research study is to look at concentrations of GSK189075 in blood when     different long and short acting forms of the drug are taken by mouth. The results will help     to decide whether a long-acting form of GSK189075 can be made. The effects of the drug on the     body and safety will also be studied.   "
206890|NCT00559897|"     RATIONALE: A positron emission tomography scan is a procedure in which a small amount of     radioactive sugar is injected into a vein, and a scanner is used to make detailed,     computerized pictures of areas inside the body where tumor cells are found. This study is     looking at whether the drug zoledronic acid interferes with the ability of a PET scan to find     tumor cells.      PURPOSE: This phase II trial is studying how well positron emission tomography works when     given together with zoledronic acid in finding tumor cells in patients with advanced     non-small cell lung cancer.   "
206891|NCT00559910|"     PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is     associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential     safety and efficacy profile in COPD.   "
206892|NCT00559936|"     The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab     (Avastin) for treatment of corneal neovascularization.   "
206893|NCT00559949|"     This phase II trial is studying how well selumetinib works in treating patients with     papillary thyroid cancer that did not respond to radioactive iodine. Selumetinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
206894|NCT00559962|"     To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin,     ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic     Resonance Spectroscopy   "
206895|NCT00559975|"     To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with     CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in     healthy adults. Safety will be assessed by observation of symptoms, physical examination     findings and laboratory safety testing.   "
206896|NCT00559988|"     The IMPACT Study will investigate the potential clinical benefit of the combined use of     BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to     conventional device evaluation and physician-directed anticoagulation in patients with     implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.   "
206897|NCT00560001|"     The objective of this study is to quantify the benefits of using the MD.2 on health outcomes.   "
206898|NCT00560014|"     The purpose of this study is to look at lipid profiles of plasma and RBC and amino acid     profiles in plasma to determine if they are associated with allograft rejection, calcineurin     inhibitor toxicity or new onset diabetes mellitus in renal transplant patients receiving     dietary supplements with arginine and omega-3 fatty acids.   "
206899|NCT00560027|"     The objective of the study was to assess the prevalence, timing, and co-occurrence of     positive screens for maternal postpartum depression (PPD) and intimate partner violence (IPV)     for women bringing their young infants for pediatric primary care and examine relationships     between PPD, IPV and children's healthcare utilization from birth to 2 years.   "
206900|NCT00560040|"     To determine if pre-race training effects heart damage induced by marathon running.   "
206901|NCT00560053|"     The study objectives are to investigate the toxicity and the BUMEL response rate; in patients     who reach the CR after autotransplantation, investigate if negativization of IF, influences     in disease evolution; in patients in PR after autotransplantation, analyze if the second     intensive procedure is capable of increasing the response rate and increasing the survival so     that patients who reached the CR with the first transplantation; Patients with MM primarily     resistant to the chemotherapy, investigate the efficacy of a double transplantation; patients     submitted to double transplantation, control the efficacy of the second transplantation in     front of allogenic transplantation.   "
206902|NCT00560066|"     Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian     Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and     without underlying medical conditions and evaluation of the immunogenicity in a subset of     subjects with underlying medical conditions, compared to an egg-based vaccine in a post     marketing setting.   "
206903|NCT00560079|"     This study aims to evaluate the potential antimanic efficacy, safety and tolorability of the     purinergic agents allopurinol and dipyridamole as an add-on treatment to lithium in a sample     of 180 drug-free manic patients enrolled in a double-blind, placebo-controlled design.   "
206904|NCT00560092|"     Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the     central nervous system [1]. Magnesium deficiency is associated to an increased activation of     these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site     of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium     may have anti-hyperalgesic effect when administered intrathecally [2]. As intrathecal     magnesium has already been used in humans for treatment of eclampsia, we stated that it could     also improve postoperative analgesia and reduce the need for auto-administered morphine if     given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and     sufentanil) injected for orthopedic surgery.   "
206905|NCT00560105|"     This is an eight-week, randomized, controlled, two arm parallel study. The study consists of,     a screening visit, two weeks of intervention-free run-in randomization, clinic visits week 0,     1, 2, 4, 6, and 8 weeks during the intervention period to collect 24 hour sputum and to     confirm techniques of device use and entries into daily diaries. Twenty-four (24) hour sputum     samples will be collected and weighed at each clinic visit. In addition to clinic visits,     subjects will be expected to make daily diary entries of COPD symptoms. Clinical evaluation     will include adverse event surveillance, and St. Georges Respiratory questionnaire.   "
206906|NCT00560118|"     RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors     predict how well patients will respond to treatment.      PURPOSE: This phase II trial is studying fotemustine to see how well it works in treating     patients with metastatic melanoma.   "
206907|NCT00560131|"     To evaluate the autonomic cardiac function in patients with complex regional pain syndrome   "
206908|NCT00560144|"     This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in     children and adolescents with advanced solid tumors equivalent to the exposure achieved in     adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated     dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be     sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to     exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of     patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is     until disease progression or dose limiting toxicity, and the target sample size is <100     individuals.   "
206909|NCT00560157|"     Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with     those of a standard polymeric one, in ICU patients   "
206910|NCT00560170|"     Multiple clinical trials, using 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase     inhibitors (statins), have shown benefit in the primary and secondary prevention of     atherosclerotic complications. However, till now, there is an incomplete understanding of all     the mechanisms of the biologic effects of statins beyond LDL cholesterol (LDL-C) reduction,     but there is accumulating evidence that the Rho-GTP/Rho-Kinase pathway (Rho/Rho-K) plays an     important role and may be a strategic therapeutic target in cardiovascular diseases. With     similar LDL-C reduction ability, the availability of Ezetimibe offers the potential to begin     to address the question whether some of the benefits conferred by statins may accrue     independently of their effects on LDL-C lowering. A better understanding of the role of the     Rho/Rho-kinase signaling pathway in the pathogenesis of atherosclerosis in human is     essential. Inhibition of Rho/Rho-kinase by statins may explain some of the biological     beneficial effects of statins observed in clinical trials. This study aims to translate into     patients important experimental discoveries regarding the initiation of inflammation in     atherosclerosis in an attempt to improve upon the present treatment of cardiovascular     diseases.   "
206911|NCT00560183|"     This study will explore the efficacy and safety of a fixed dose combination of morphine and     oxycodone for management of acute postoperative pain. The study will explore the efficacy     dose response and dosing interval required to maintain adequate analgesia at each tested     dosage strength.   "
206912|NCT00560196|"     The purpose of the study is to investigate pain, anxiety and depression in patients with     panic anxiety disorders without pain or depression without pain compared with healthy     volunteers   "
206913|NCT00560209|"     The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients     scheduled for coronary angiography, in a double-blind, randomized, placebo-controlled,     parallel group, multi-center study.   "
206914|NCT00560222|"     Much has been learned in recent years about the mechanisms by which breastfeeding improves     child health and survival. However, there has been little progress in using these insights to     improve pediatric care. Factors that are important for protecting the breast fed infant might     be expected to decrease the adverse effects of weaning on diarrhea, growth, and development.     The proposed study is meant to begin addressing this important gap by a clinical trial of     lactoferrin supplementation in previously weaned children. Lactoferrin,an iron-binding     protein with multiple physiological functions (anti-microbial, anti-inflammatory, and     immunomodulatory), is one of the most important proteins present in mammalian milk. Our     hypothesis is that lactoferrin (given as a daily supplement in amounts similar to those     consumed if the child were still breastfed) will improve health by mimicking its protective     roles in milk. The significance of these studies is that they will prove feasibility of     improving child health after the end of breastfeeding by continuing ingestion of a major     protective milk protein. Diarrhea and malnutrition after weaning is a global problem that may     be amenable to this approach.   "
206915|NCT00560235|"     Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors   "
206916|NCT00560248|"     The purpose of this registry is to assess and improve the process of care and health outcomes     of patients presenting to the Emergency Department with chest pain suspected to be of cardiac     origin. The study will identify which methods facilitate the diagnosis and risk     stratification of ST elevation myocardial infarction (STEMI) or non STEMI, including patients     with occult myocardial infarction (MI), and result in a shorter time to definitive diagnosis     and treatment.   "
206917|NCT00560261|"     Sickle cell disease (SCD) is the most common inherited disease of the world affecting African     and Caribbean populations. SCD is caused by the homozygous inheritance of the gene for sickle     hemoglobin (HbS). Most patients with SCD develop abnormal pulmonary function characterized by     airway obstruction, restrictive lung disease, abnormal diffusing capacity, hypoxemia and     pulmonary hypertension In healthy subjects, lung capillary blood volume (Qc) and membrane     diffusing capacity (Dm) can be accurately measured by the nitric oxide-carbon monoxide     (NO-CO) method. We propose to study, for the first time, lung capillary blood volume and     alveolar membrane diffusing capacity, using the NO-CO method, in children with SCD aged of at     least 6 years Early determination of lung function and pulmonary circulation in children with     SCD is very important, not only for the understanding of physiopathologic mechanisms of the     disease but also for a better therapeutic management of these children.   "
206918|NCT00560274|"     This single arm study will assess the safety of NeoRecormon in the correction of anemia in     patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin     combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c.     which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time     on study treatment is 1 year, and the target sample size is 100-500 individuals.   "
207033|NCT00561782|"     The goal of this study is to compare the changes that occur in sensation and chemical     properties of the brain following SCI between individuals that experience chronic pain and     those that do not, and between those with SCI and the able-bodied.   "
206919|NCT00560287|"     Non-invasive mechanical ventilation (NIV) has been increasingly used as a treatment of     chronic hypercapnic respiratory failure. Its use in patients affected by chronic obstructive     pulmonary disorders is still controversial, while most of the studies performed in     restrictive thoracic disorders (RTD), and in particular in neuromuscular patients, suggested     alleviation of the symptoms of chronic hypoventilation in the short term, and in two small     studies survival was prolonged.      In the terminal phase of the disease, when the respiratory muscles became weaker it is very     likely that the operators need to frequently adjust the level of inspiratory pressure in an     attempt to guarantee an adequate tidal volume, so that alveolar hypoventilation may be     avoided.      Theoretically the use of a volume assisted ventilation may overpass this problem of frequent     variations of the settings, since the provision of a fixed tidal volume may always guarantee     and adequate alveolar ventilation.      The primary aims of this multicenter randomized study are to evaluate the clinical efficacy,     the patients' tolerance and quality of life and the frequency of changing settings in a group     of patients with SLS and initial chronic respiratory failure undergoing long-term NIV with     Pressure Support Ventilation or Volume Assisted Ventilation.   "
206920|NCT00560300|"     To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and     two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests     of children with kidney failure   "
206921|NCT00560313|"     This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of     Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to     healthy at-risk adults.   "
206922|NCT00560326|"     The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment     as long-term treatment in paediatric patients with atopic dermatitis.   "
206923|NCT00560339|"     The purpose of this study is to determine whether there is a relationship between serial     B-natriuretic peptide (BNP) and implantable device measured intrathoracic impedance in     symptomatic and asymptomatic heart failure patients over a 1-year period. Furthermore, this     study will establish whether implantable device measured intrathoracic impedance trends with     the distance walked on a six-minute hall walk (6MHW), an exercise-based acute measure that     has also been associated with heart failure clinical status.   "
206924|NCT00560352|"     The purpose of this study is to determine the safety and tolerability of dasatinib with     bortezomib in the treatment of relapsed or refractory multiple myeloma.   "
206925|NCT00560365|"     RATIONALE: Following patients who have undergone surgery for colorectal cancer may help     doctors learn more about the disease and plan better follow-up care.      PURPOSE: This randomized clinical trial is following patients who have undergone surgery for     stage I, stage II, or stage III colorectal cancer.   "
206926|NCT00560378|"     Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema     are entitled to enter this four-year follow study to investigate the safety of treatment with     Tacrolimus ointment 0.1%   "
206927|NCT00560391|"     The purpose of this study was to determine the safety and tolerability of dasatinib when     given in combination with lenalidomide and a low dose dexamethasone for the treatment of     relapsed or refractory multiple myeloma.   "
206928|NCT00560404|"     This 2 arm study will compare the efficacy and safety of monthly administration of     subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis     patients with chronic renal anemia. Patients currently receiving maintenance treatment with     epoetin alfa will be randomized to receive either monthly injections of Mircera with a     starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were     receiving in the week preceding study start, or to continue on epoetin alfa treatment. The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
206929|NCT00560417|"     This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in     combination with the patient's oral diabetes medications and exenatide, for their ability to     control blood sugar in patients with type 2 diabetes.   "
206930|NCT00560430|"     A number of studies have shown that certain blood-pressure medications such as ACE-inhibitors     and angiotensin-II-receptor blockers (ARB) can reduce the incidence of diabetes mellitus type     2. This protocol will evaluate whether inflammatory mechanisms mediate this effect. The     investigators therefore will investigate the effect of telmisartan, a potent ARB, on lipid     metabolism, glucose metabolism and inflammation in patients with the metabolic syndrome.     Specific parameters will be tested before treatment and after 3 months of treatment. Placebo     will be compared to 2 different doses of telmisartan per day.   "
206931|NCT00560443|"     Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic     regimes per os on pain due to not compound bone fractures in child 4-17 years old:        -  ketorolac 0,5 mg/kg (1 drop every 2 Kg)        -  tramadol 2,5 mg/Kh (1 drop every 2 Kg)      Intensity of pain will be estimated with linear 1 to 10 or analogic McGrath type scale every     20 min.      The main objectives are the evaluation of pain decreasing in every group, the time of     decreasing, the intensity of pain during procedures (ex. Xray) and the occurrence of side     effects Secondary outcomes are comparison between the two groups on effectiveness on pain and     on side effects   "
206932|NCT00560456|"     Young subjects and patients with nocturnal respiratory disorders are frequently involved in     sleep-related accidents. This study assess the impact of chronic sleep restriction (4 hr of     sleep during 5 days) or total sleep deprivation in young or mature healthy subjects or     snorers on simulated driving, objective and subjective sleepiness and objective and     subjective cognitive performances. The effects of recovery night on these parameters are also     assessed.   "
206963|NCT00560859|"     The purpose of this research is to determine the effect of adenotonsillectomy surgery     (removal of tonsils and adenoids) on obstructive sleep apnea syndrome (OSAS) in children.     OSAS can cause health problems including poor growth, high blood pressure, diabetes and     behavioral and learning difficulties. Although adenotonsillectomy is the usual treatment for     children with OSAS, it is not known with any certainty if the child's OSAS symptoms improve     afterwards. This study will help determine if improvement occurs or if it does not. It will     also look at whether certain groups, such as children who are overweight or of different     ethnicities, are helped by the surgery.   "
213345|NCT00645736|"     This study has the aim of describing viral mutation profiles in patients diagnosed with     chronic hepatitis B receiving antihepadnaviral therapy.   "
206933|NCT00560469|"     Obesity is a strong risk factor for developing type 2 diabetes (T2DM), but the reasons for     this are not fully understood. In particular, it is not known why some obese people develop     T2DM while other obese individuals do not. This study tests whether differences in fat cells     (adipocytes) are to blame. Even in adults, fat cells are constantly being formed to replace     old fat cells and to respond to the body's need to store excess energy. The ability to form     new fat cells may be diminished in some individuals, leading to larger fat cells. These large     fat cells secrete hormones that may increase risk for T2DM. This study tests whether fat     cells from obese insulin resistant subjects (who are at risk for developing T2DM) form at a     slower rate than those from insulin sensitive subjects (who are at lower risk for developing     T2DM).      To address this question we will recruit and study two groups of obese subjects, selected to     be similar in age, gender and degree of obesity. One group of subjects will be obese and     insulin resistant (the OIR group), while the other will be comparably obese, but insulin     sensitive (OIS). Subjects will undergo a series of studies to characterize their metabolism     including measurement of body fat by DEXA scanning, oral glucose tolerance (a test used to     diagnose diabetes) and measurement of insulin sensitivity in response to an infusion of     insulin (a research study used to classify patients into the OIR and OIS groups). Small     samples of fat (from just under the skin of the belly and the buttocks) will obtained using a     needle on two occasions over 12 weeks. During these 12 weeks, subjects will drink a small     amount of water that contains a non-radioactive label. This labeled water will allow us to     measure the rate of growth of new fat cells in the body. We will also look at the rate of     growth of fat cells obtained from these biopsies in the laboratory.      The results of this study may tell us more about why certain obese people develop diabetes     and why others do not. This might lead to new ways to prevent or treat T2DM.   "
206934|NCT00560482|"     To investigate ABR-215050 as a possible treatment for prostate cancer.   "
206935|NCT00560495|"     RATIONALE: Ammonium tetrathiomolybdate may stop the growth of non-small cell lung cancer by     blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor     cells. Giving ammonium tetrathiomolybdate together with radiation therapy may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects of giving radiation therapy together     with ammonium tetrathiomolybdate in treating patients with stage I, stage II, or stage III     non-small cell lung cancer.   "
206936|NCT00560508|"     The objective of this trial is to investigate the safety, tolerability, trough plasma     concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR     administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the     double-blind period). The double-blind period will be followed by the open-label 52 week     administration of pramipexole ER to evaluate the long term safety and efficacy (the     open-label period).   "
206937|NCT00560521|"     Tuberculosis (TB) remains as an important public health problem worldwide. Pleural     tuberculosis is the most prevalent form of extrapulmonary presentation in immunocompetent     patients.      The volume of effusion in the pleural space of patients with pleural TB may cause     complications like restrictive ventilator lung functional disturb and/or pleural thickening.     The respiratory physiotherapy can be adjuvant on treatment of pleural effusion tuberculosis     throughout of various treatment technique.      The Continuous positive airway pressure (CPAP) is utilized in various pathologic, this     improves lung mechanics by recruiting atelectatic alveoli, improving pulmonary compliance,     and reducing the work of breathing.      The aim of this study is to determine the effect of CPAP on fluid absorption among patients     with pleural effusion due tuberculosis.   "
206938|NCT00560534|"     To investigate the diagnostic performance of whole body magnetic resonance angiography     (WB-MRA) using subsystolic venous compression of the thigh.   "
206939|NCT00560547|"     This single arm study will assess the long-term maintenance of hemoglobin levels, safety and     tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients     with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa     maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360     micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be     adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
206940|NCT00560560|"     This study will test if there is any survival benefit in patients with refractory metastatic     colorectal cancer that receive CP-751, 871.   "
206941|NCT00560573|"     CP 751,871 is a fully human monoclonal antibody against the Insulin-Like Growth Factor 1     Receptor (IGF-1R). Preclinical and clinical data indicate that CP 751,871 augments the     anti-tumor activity of chemotherapy. This study will identify the Maximal Tolerated Dose of     CP 751,871 (or the Maximal Feasible Dose) in combination with standard gemcitabine-cisplatin     chemotherapy for the treatment of advanced Non-Small Cell Lung cancer.   "
206942|NCT00560586|"     -Intranasal budesonide therapy may lead to improved symptoms and sleep study findings in     children with mild obstructive sleep apnea with and without allergic rhinitis that would not     be treated with T&A. The aim of the study is to conduct a randomized double blind cross-over     trial comparing the effect of once a day intranasal budesonide therapy vs. placebo in     children with mild sleep apnea that would not be candidates for T&A.   "
206943|NCT00560599|"     This clinical trial tests the hypotheses that 1) body decolonization of patients with     recurrent community-associated (CA) MRSA infections and their household members and 2)     environmental decolonization of the patients' households will significantly reduce the     likelihood of recurrent CA-MRSA infection.   "
206944|NCT00560612|"     The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine     for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the     early post-deployment period; and 2) To determine the potential efficacy of paroxetine in     preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and     improving overall veteran function.   "
206945|NCT00560625|"     Inhaled corticosteroids are largely used in patients with asthma or chronic obstructive lung     diseases. The purpose of this study is to determine if the use of inhaled corticosteroids is     associated with suppression of endogenous cortisol production, as seen in patients treated     with pharmacologic doses of oral or parenteral steroids.   "
206946|NCT00560638|"     This was a single-center, randomized, double-masked, placebo-controlled, parallel-group,     4-visit, CAE (Controlled Adverse Environment) study lasting approximately 4 weeks. Subjects     were randomized to receive loteprednol etabonate ophthalmic suspension, 0.5% or placebo     (vehicle of loteprednol etabonate ophthalmic suspension, 0.5%) and instructed to dose     bilaterally either TID or QID according to randomization.   "
206964|NCT00560872|"     The purpose of this study is to evaluate the influence of remote magnetic catheter navigation     on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid     isthmus in patients with typical atrial flutter.   "
206947|NCT00560651|"     Corneal Cross Linking is new treatment modality for patients with keratoconus. A keratoconus     is characterized by progressive bulging and thinning of the eye's cornea. Keratoconus is a     potentially severely sight impairing condition that may necessitate corneal transplantation     in the progressive state.      Corneal Cross Linking is designed to        -  increase the cornea's mechanical stability        -  to stop progression of bulging and thinning of the cornea        -  to prevent the need for corneal transplantation      Corneal Cross Linking is performed by        1. Applying Riboflavin (Vitamin B2) eye drops every 2 minutes for 30 minutes to the cornea        2. Illuminating the cornea with UV-light      This register of Corneal Cross Linking procedures performed in Germany serves to        -  gather long-term results        -  detect rare complications and side-effects        -  evaluate the efficacy in a large number of patients   "
206948|NCT00560664|"     Numerous surgical techniques have been developped for the treatment of chondral and     osteochondral defects of the knee. Among those techniques autologous chondrocyte     transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF     is available. The aim of this randomized trial is to compared this new ACT technique to     mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring     system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64     patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at     a 5% alpha level. Twelve surgical centers in France are involved.   "
206949|NCT00560677|"     We propose to establish a database characterizing the presence or absence of comorbid PTSD in     veterans with schizophrenia or schizoaffective disorder (SAD) receiving services at the     Durham VA Medical Center. In addition to the evaluation of PTSD symptoms in veterans with     schizophrenia or SAD, this database will facilitate the investigation of a number of     additional specific research questions relevant to veterans with psychotic disorders.   "
206950|NCT00560690|"     Insulin resistance is known to adversely effect viral response to treatment in hepatitis C     patients      We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of     hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized     controlled trial   "
206951|NCT00560703|"     To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of     patients who have both blepharitis and facial rosacea   "
206952|NCT00560716|"     This is a phase I study of an investigational cancer drug, CYC116, in patients with advanced     solid tumors.   "
206953|NCT00560729|"     Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional     supplementation in elderly patients   "
206954|NCT00560742|"     The purpose of this study is to determine whether the administration of patient's own bone     marrow cells into scar areas of the heart, can improve the contractile function of these     areas.   "
206955|NCT00560755|"     Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured     with rHA when administered to children in their second year of life.      Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured     with rHA when administered to children in their second year of life   "
206956|NCT00560768|"     The aim of the study is to assess the negative predictive value of the T amplitude variance     as a method for risk stratification for patients with an increased risk for SCD.   "
206957|NCT00560781|"     This study will test the therapeutic potential of augmenting a stable SSRI regimen with the     neurosteroid pregnenolone to reduce cognitive symptoms and PTSD symptoms in patients     diagnosed with PTSD.   "
206958|NCT00560794|"     The purpose of this study is to determine whether the bispecific T-cell engager (BiTE®)     Blinatumomab (MT103) is effective in the treatment of ALL patients with minimal residual     disease.   "
206959|NCT00560807|"     This study will determine biological responses to different dosages of neck mobilization     intervention in patients, providing opportunities to identify the optimal dosage, predictors     of response, outcome measures as well as the longitudinal changes in biology.      Subjects with acute whiplash associated disorders (WAD) II and III with a symptom duration of     less than 30 days (acute) or 30 to 90 days (subacute) will be randomly assigned to receive     different doses of mobilization. The dosage treatment groups will differ in the number of     sessions (1, 2 or 3 times per week) and the duration of treatment (duration of treatment     intervention will be 3, 6, or 12 weeks). A zero treatment/week option is included to insure     that the impact of any mobilization is included and because previous studies suggest a single     mobilization may have a treatment effect.      All patient participants will receive a core standard treatment of education, advice to stay     active, and neck/postural stretching and strengthening exercise. All patient participants     will receive supervised exercise and advice for the full 12 weeks. All patients will be     provided with an instructional CD and exercise brochure to reinforce the whole program.      Follow-up assessments will consist of quantitative sensory testing (vibration threshold;     current perception threshold), the Neck Walk Index (NWI), the Upper Cyclical Reach and Grasp     Task, muscle biology analyses (cytokine analyses), central breathing control tests     (capnography), range of motion, head flexion endurance, and self-report symptoms and     disability (Visual Analogue Scale; Neck Disability Index; Disabilities of the Arm, Shoulder,     Hand; pain threshold and tolerance algometry; and perceived self-efficacy; SF-36).      Hypothesis: During recovery, patient are expected to transition from an acute painful state     to one where they can resume normal activity and add intensive strengthening exercises.   "
206960|NCT00560820|"     The primary purpose of this study is to evaluate the effect of deferasirox on renal     hemodynamics by determining glomerular filtration rate (GFR), renal plasma flow (RPF) and     filtration fraction (FF).   "
206961|NCT00560833|"     The most direct treatment of vasomotor symptions (hot flushes) may be by means of 5-HT2A     receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be     effective in reducing the number and intensity of hot flushes in preliminary trials. Also     several Selective Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been     investigated to manage hot flushes, confirming the role of the serotonergic system. In the     present trial, the efficacy and safety of four different doses of esmirtazapine compared to     placebo was investigated in women with moderate to severe vasomotor symptoms associated with     the menopause. The primary study hypothesis was that esmirtazapine would show superior     efficacy to placebo.   "
206962|NCT00560846|"     The aim of this study is to demonstrate the influence of peri-operative nutrition on the     post-operative complications, preservation of lean body mass and length of stay after     gastrectomy or oesophagectomy.   "
206965|NCT00560885|"     ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety     and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation     during concomitant on-pump cardiac surgery.   "
206966|NCT00560898|"     The purpose of this study is to measure the relative barrier function of the top layer of     the cornea (called the epithelium), or the degree to which the cornea can prevent the     penetration of the colored dye sodium fluorescein into the eye. This is a clinical     investigation of the effect on corneal barrier function following wear of two contact lens     materials and two contact lens care systems, approved for marketing in the US by the Food and     Drug Administration. These contact lenses will be worn for two hours, following soak in one     of two marketed contact lens disinfecting solutions. Approximately 25 young, adapted contact     lens wearers will participate.   "
206967|NCT00560911|"     Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC).     However, no study has yet assessed the safety and efficacy of OAC self-management in elderly     patients with major thromboembolic and haemorrhagic complications as primary outcomes.      In this multi-centre, open, randomised controlled trial, patients aged 60 years or will be     randomised into a self-management or routine care group and followed up for at least two     years.      The primary hypothesis of the study is that self-management of oral anticoagulation is     superior compared to routine control in terms of reducing thromboembolic events requiring     hospitalisation and all major bleeding complications as the primary endpoint.   "
206968|NCT00560924|"     This trial is conducted in Europe. The aim of this trial is to investigate the preventive     effect of treatment with estradiol vaginal tablets on recurrent urinary tract infections     (RUTI) in post-menopausal women with signs of urogenital ageing (UGA).   "
206969|NCT00560937|"     This is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. The     goal of this placebo-controlled study is to provide preliminary efficacy data for potential     pregnenolone effects on cognitive symptoms and negative symptoms in patients with     schizophrenia. Depressive symptoms and positive symptoms will also be assessed.   "
206970|NCT00560950|"     The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well     tolerated and produces an immune response in older adults.   "
206971|NCT00560963|"     A dose finding study in locally advanced and/or metastatic pancreatic cancer patients   "
206972|NCT00560976|"     The purpose of this study is to assess changes in serum levels of the siderophore binding     protein NGAL by hemodialysis without and with intravenous iron administration   "
206973|NCT00560989|"     Granulomatous lung diseases are diseases in which inflamed clusters of white cells, known as     granulomas, form in lung tissue. Chronic beryllium disease (CBD) and sarcoidosis are two     granulomatous diseases that share similar clinical symptoms, physiological changes in the     lungs, and immune responses to the disease. Genetic variations may make some people more     susceptible to developing CBD or sarcoidosis. This study will identify common genetic regions     associated with increased risk of developing the granulomatous diseases CBD and sarcoidosis.   "
206974|NCT00561002|"     To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from     healthy children receiving the 2007-2008 formulation of the inactivated, split-virion     influenza vaccine Fluzone® for further study.   "
206975|NCT00561015|"     The purpose of this study is to assess the effect of telaprevir on early hepatitis     (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who     are chronically (lasting a long time) infected with genotype 2 or 3 HCV.   "
206976|NCT00561028|"     To test the association between anti-Chlamydia serum titers and anti-Mycoplasma antibodies     with Acute Coronary Syndromes.   "
206977|NCT00561041|"     The study examines the relative efficacy of two active aftercare interventions (i.e.,     face-to-face , brief phone) with no-active aftercare for adolescents who completed outpatient     treatment for alcohol use disorders(AUD)   "
206978|NCT00561054|"     Lung cancer is the leading cause of cancer deaths worldwide. It is estimated that, in 2004,     173,700 new cases of lung cancer will be diagnosed in the United States alone and 164,440     deaths due to this disease will occur(13) . NSCLC accounts for approximately 80% of all lung     cancers. Among NSCLC cases approximately 30% present with locally advanced and 40% with     metastatic disease (14,15) . In metastatic disease, chemotherapy is the treatment of choice,     but benefits obtained in survival have been modest. Five-year survival is less than 15%,     probably due to diagnosis at late stages. Surgical results in earlier stages are poor     compared to other tumor types (about 40% of recurrence in stages I-II). Results of     chemotherapy in advanced stages are also poor (one-year survival of 40%) (15,17). It is     commonly accepted that the standard treatment for advanced disease (stage IV and IIIb with     malignant pleural effusion) consists of platinum-based chemotherapy(15,16) . However, there     are many open questions in the management of these patients, such as the role of 3-drugs     combinations, non-platinum-based therapies, and new biologic therapeutics' approaches.     Currently, in the treatment of advanced NSCLC response rates of about 20%-30% and median     survival times of 6 to 11 months have been achieved (16, 17, 18, 19, 20, 21, 22,). Several     combinations of drugs are used and show similar efficacy. Cisplatin plus vinorelbine or     Cisplatin plus Gemcitabine are among the most commonly used regimens in the first-line     therapy of NSCLC.   "
206979|NCT00561067|"     The purpose of this study is to evaluate the tolerability and efficacy of erythropoietin     (EPO) treatment in spinal shock in comparison with the methylprednisolone treatment (MP).   "
206980|NCT00561080|"     Primary objective:      Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster     virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month     schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks     post-vaccination      Secondary objectives Immunogenicity        -  To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen          and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®.        -  To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen          with the VZV antibody titres at 12 months after completion of each 2-doses regimen of          ZOSTAVAX®        -  To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose          regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®   "
206981|NCT00561093|"     Study of efficiency and safety of oral nutritional supplements with anti-inflammatory and     antioxidative properties combined with an appetite stimulant with anti-inflammatory     properties (pentoxiphylline) in treatment of malnutrition-inflammation-cachexia syndrome in     maintenance hemodialysis patients   "
206983|NCT00561119|"     The primary goal of therapy in patients with metastatic breast cancer is palliation and     prolongation of life with quality. Although there are no randomized trials comparing     chemotherapy with supportive care in women with metastatic breast cancer, chemotherapy     clearly provides a survival benefit in metastatic breast cancer. Due to diagnosis at earlier     phases of metastatic disease and more effective therapies, the median survival of patients     treated with modern taxane-based chemotherapy is now reaching approximately 2 years. The     duration of chemotherapy in patients responding or stable disease remains controversial,     since quality of life is not usually adversely affected and may even be improved in many     patients receiving cytotoxic chemotherapy. In addition, many commonly used chemotherapeutic     agents are not limited by cumulative toxicity in metastatic breast cancer patients. Several     studies investigated the role of maintenance chemotherapy suggest that maintenance     chemotherapy is associated with superior time to progression but no survival gain. However,     these randomized trials did not incorporate taxane-based chemotherapeutic regimens, the new     standard of care in metastatic breast cancer patients these days. A 1998 metaanalysis of     1,986 patients randomly assigned between combination chemotherapy and single-agent therapy in     metastatic breast cancer patients demonstrated a survival advantage to combination     chemotherapy, with a hazard ratio of 0.82 (range, 0.75 to 0.90). Although there are several     randomized trials showing negative results for survival gain in patients who received     maintenance chemotherapy, the role of maintenance chemotherapy with newer agents, such as     docetaxel or paclitaxel, have not been established yet. Although Italian MANTA trial     demonstrated no difference in PFS or survival between the two arms, their metaanalysis     advocated survival benefit of maintenance therapy. Since gemcitabine/paclitaxel (GP)     combination chemotherapy is one of the two regimens which showed definite survival gain with     favorable toxicity from a randomized trial, we plan to randomize patients who responded to     six cycles of GP induction chemotherapy to receive additional maintenance GP chemotherapy     until disease progression versus observation. We hypothesize that patients who receive     maintenance GP chemotherapy will do better in terms of progression free survival.   "
206984|NCT00561132|"     The purpose of this study was to evaluate if the vanadium can improve the insulin sensitivity     in patients with impaired glucose tolerance. Secondary purpose of this study was to assess     changes on metabolic profile, weight and blood pressure.   "
206985|NCT00561145|"     Over the past century life expectancy has risen rapidly. As a result, the proportion of     elderly people continues to grow. Elderly people probably have an impaired regulation of     energy balance (energy intake versus energy expenditure) whereby the underlying physiological     mechanisms are not fully understood.      The first objective of this study is to provide further evidence for an age-related failure     to regulate energy balance in elderly. If the hypothesis of impaired regulation of energy     balance in elderly is confirmed then the second objective becomes to elucidate the underlying     physiological mechanisms of the age-related failure to regulate energy intake in elderly.   "
206986|NCT00561158|"     The purpose of the study is to develop and evaluate a dietary change program specifically for     low-income, African-American women who are at risk for developing diabetes due to obesity.     The program uses an innovative approach that emphasizes risk awareness, self-efficacy, and     skills training through active learning exercises related to healthy eating. The program is     delivered by peer educators in the community and addresses economic and cultural factors that     are very important to program participants.   "
206987|NCT00561171|"     This is a phase II a, double-blind, randomized, parallel-design, four-week study to     investigate the efficacy, safety and tolerability of two different doses of SPP635 in type II     diabetic patients with mild to moderate hypertension and albuminuria.      The total study duration for patients completing the entire study will be approximately 7     weeks including a 2 weeks Screening Phase, 1 week Wash-out Phase, 4 week Treatment Phase and     1 week Follow-up Phase.      All treatments other than certain antihypertensive drugs (which are to be washed-out) with an     effect on BP and all antidiabetic treatments must be kept at stable dose during the whole     study.      A maximum of 50 patients in total is planned to be enrolled.   "
206988|NCT00561184|"     To assess persistence of antibody titers 17-18 months after primary immunization with two     0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen,     as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and     Microneutralization (MN) test   "
206989|NCT00561197|"     This is a Phase 1/ 2, open-label, single-center study of preoperative chemoradiotherapy and     AT-101 in patients with locally advanced esophageal or gastroesophageal junction cancer.   "
206990|NCT00561210|"     Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune     enhancing diet versus polymeric diet)in severe burn hospitalized patients .   "
206991|NCT00561223|"     The investigators believe that iloprost will improve gas exchange in COPD patients with     pulmonary hypertension.   "
206992|NCT00561236|"     The use of intravitreal corticosteroids in the management ocular inflammatory diseases has     recently gained widespread acceptance. The purpose of this study is to determine if the use     of intravitreal triamcinolone is associated with suppression of endogenous cortisol     production, as generally admitted for patients treated with oral or parenteral corticosteroid     therapy.   "
206993|NCT00561249|"     At the time of transfer of frozen/thawed embryos in human IVF/ICSI, patients are randomized     between study and control group.In the control group no additional intervention takes place     on the embryos to be transferred,in the study group, embryos for transfer are subjected to     laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two     minutes per embryo.   "
206994|NCT00561262|"     RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by     heating them without affecting normal tissue.      PURPOSE: This phase II trial is studying how well high-intensity focused ultrasound ablation     therapy works in treating patients with localized prostate cancer.   "
206995|NCT00561275|"     This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients     with esophageal cancer.   "
206996|NCT00561288|"     The purpose of the study is to investigate whether ingestion of acetaminophen reduces the     experience of hurt feelings.   "
206997|NCT00561301|"     - To evaluate the feasibility of combination chemotherapies comprising of     gemcitabine-dexamethasone-oxaliplatin for patients with refractory or relapsed malignant     non-Hodgkin lymphoma (NHL)   "
206998|NCT00561314|"     RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the     tumor without affecting the surrounding tissue.      PURPOSE: This phase II trial is studying the side effects and how well highly focused     ultrasound energy works in treating patients with localized prostate cancer.   "
206999|NCT00561327|"     The purpose of this study is to determine whether losartan metabolites are effective in     inducing PPARγ target genes in monocytes in losartan-treated patients.   "
207000|NCT00561340|"     The purpose of this study is to see if supplementing calories with Pediasure is effective in     maintaining height, weight, and BMI percentiles for young children during 2 years of     treatment with ADHD medication.   "
207478|NCT00558090|"     The purpose of this study is to determine the influence of morphine 2,5 mg or morphine 7,5 mg     iv during a painful and unavoidable intervention in critically ill patients.   "
207001|NCT00561353|"     The purpose of this study is to investigate how efficient TMC435350 will work against the     Hepatitis C virus genotype 1 (genotypes refer to the genetic constitution of the virus) and     what the concentrations of TMC435350 in the blood are with or without pegylated interferon     alpha-2a (PegIFNa-2a) or PegIFNa-2a plus ribavirin.   "
207002|NCT00561366|"     Arimoclomol is a small molecule that upregulates molecular chaperones in cells under     stress. Arimoclomol extends survival by five weeks when given both pre-symptomatically and at     disease onset in a mutant superoxide dismutase (SOD1) transgenic mouse model of ALS.     Furthermore, it has been demonstrated to have neuroprotective and neuroregenerative effects     in other rat models of nerve damage. Molecular chaperone proteins are critical in the     cellular response to stress and protein misfolding. Recent data suggest that the SOD1     mutation responsible for ALS in some patients with familial disease reduces the availability     of a variety of molecular chaperones, and thus weakens their ability to respond to cellular     stress. Protein misfolding and consequent aggregation may play a role in the pathogenesis of     both the familial and sporadic forms of ALS. Therapeutic agents such as arimoclomol that     improve cellular chaperone response to protein misfolding may be helpful in ALS.   "
207003|NCT00561379|"     The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III     or IV with 1 to 3 adverse prognostic factors according to the International prognostic index.     Patients with eligibility criteria and who gave informed consent will be randomised between     CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous     stem cell support. The aim of the study is to compare the Event free survival between the two     arms and to gain insight into the prognostic significance of several biological markers     gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA     profile and BCL é expression).   "
207004|NCT00561392|"     This study evaluated the safety and efficacy of 10 cm^2 rivastigmine patch in patients with     Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who     stayed on the target size of 10 cm^2 for at least 8 weeks. This proportion was then compared     to historical data of the percentage of patients who could reach a rivastigmine capsule     target dose of 12 mg and stay on it at least 8 weeks.   "
207005|NCT00561405|"     Stroke is a major cause of disability in Canadian adults. Following a stroke, many people     have difficulty walking in their home and in the community. The purpose of this study is to     compare the effect of two different approaches to walking retraining in people who have had a     stroke.      Individuals living in the community who have had recently had a stroke will be asked to     participate in this study. Participants will be randomly assigned to one of two five week     walking training programs. In one program, individuals will re-learn to walk in a variety of     real-life situations. Practice sessions will encourage active problem solving by the     participants. The other program will have participants practice walking on a treadmill while     some of their body weight is supported by a special harness system. Participants will also be     assisted by a physiotherapist to walk in a more normal manner.      Participants' will be assessed at the beginning of the study, after the 5 week training     program and again, eight weeks later. The research assistant will assess their ability to     walk, their confidence level and the average daily walking activity.      Primary Hypothesis: Individuals assigned to the Motor Learning Walking Program will improve     their walking ability from baseline to follow up assessment significantly more than     individuals assigned to the Treadmill Training Program.      The results of this study will help physiotherapists plan effective treatment programs for     individuals with walking difficulties following stroke. It will also give researchers     direction for future studies in the areas of walking retraining and motor skill development     post-stroke.   "
207006|NCT00561418|"     RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth, and may stimulate the immune system to stop cancer cells from     growing.      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat after     stem cell transplant in treating patients with high-risk lymphoma.   "
207007|NCT00561431|"     In the last three decades, the mortality associated with acute renal failure (ARF) in the ICU     has remained unchanged at greater than 50%, despite improvements in dialysis technology.      The primary objective is to determine whether Continuous Veno-Venous Hemodiafiltration     (CVVHDF) using an ultrafiltration rate of 35 ml/hr/kg (high dose) leads to a greater     reduction in all-cause ICU mortality compared to standard CVVHDF using an ultrafiltration     rate of 20 ml/hr/kg.   "
207008|NCT00561444|"     The goal of this behavioral research study is to look at patients' quality of life after     treatment or management for prostate cancer.   "
207009|NCT00561457|"     To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication     of treatment of common and/or external iliac artery occlusive disease   "
207010|NCT00561470|"     The main objective of the study was to evaluate the effectiveness of aflibercept (versus     placebo) in increasing the overall survival in participants with metastatic colorectal cancer     treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously     failed an oxaliplatin based treatment for metastatic disease.      The secondary objectives were to compare progression-free survival, to evaluate overall     response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV)     aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.   "
207034|NCT00561795|"     This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and     tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects     with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior     therapy for their disease. A minimum of 12 and a maximum of 46 subjects will be enrolled.     Dose schemas for each study arm are described in the protocol. For each arm, six subjects     will be evaluated in treatment cohorts, which will be expanded to 20 subjects if initial     toxicity is acceptable. Overall safety and tolerability of the regimen will be based on dose     limiting toxicities, adverse events, and percentage of subjects that complete 6 courses of     study treatment. Antitumor activity will be assessed using RECIST criteria and cancer antigen     125 (CA-125) responses.   "
207036|NCT00561821|"     This study was conducted to investigate the efficacy of treatment with Org 50081     (Esmirtazapine)      compared to placebo in elderly participants with chronic primary      insomnia. Primary efficacy variable is Wake time After Sleep      Onset (WASO), averaged over all in-treatment time points      and measured by polysomnography (PSG).   "
207011|NCT00561483|"     Renal Compromise after treatment of decompensated heart failure with diuretics is not     uncommon. The purpose of our study is to investigate the relationship between cystatin C and     worsening renal function in this setting. Cystatin C is a biomarker produced at a constant     rate by all cells that is a sensitive biomarker of renal function.Cystatin C and Plasma amino     terminal proB-type natriuretic peptide (NT-proBNP) levels will be obtained at baseline and     daily. Our goal is to enroll 100 subjects with an estimated 5 samples per each subject. The     time course of changes in cystatin C in relation to serum creatinine levels over time will be     plotted.      Our hypothesis is that sequential changes in cystatin C levels following initial treatment     with diuretic therapy in the setting of acute decompensated heart failure may provide early     insight into cardio-renal compromise. Understanding the natural history and time course of     the changes in sequential cystatin C levels may facilitate further studies to guide the     judicious use of diuretic therapy in acute decompensated heart failure, and to predict the     risk of subsequent development of worsening renal function. If serial testing of cystatin C     can provide accurate assessment and prediction of worsening renal function, clinical     applications of these observations can be evaluated in future prospective studies.   "
207012|NCT00561496|"     This is a multi-center, pharmacokinetic study involving a single-dose phase, a wash out phase     and a two-week once or twice-daily dosing phase for each of 49 volunteers.      In the single-dose phase, each volunteer will apply the single dose in the clinic.     Participants will be randomized to have cervicovaginal samples and biopsies collected at one     of seven time-points [0.5, 1, 2, 4, 6, 8, and 24 hour(s)] after the single-dose. Blood     samples will be drawn at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) after the single-dose.      In the two-week phase, the study supplies will be distributed and the participants will be     randomized to apply each dose either once or twice-daily for two weeks. At the one week     follow-up visit a blood sample will be drawn prior to the morning dose to obtain a trough     value and cervicovaginal samples will be collected four hours after the morning dose. At the     two week follow-up visit blood samples will be drawn prior to the morning dose to obtain a     trough value and then at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) from the final morning dose.     Participants will be randomized to have cervicovaginal samples and biopsies collected at     either 4, 8 or 24 hours after the final morning dose.      Up to 10 participants who have completed the first two phases of the study, will be asked to     participate in a third phase to have cervicovaginal samples, biopsies and blood samples     collected 12 hours after a single-dose.   "
207013|NCT00561509|"     In usual clinical conditions, depressed patients with no sexual dysfunction, after signing     their consent for the dissemination of their clinical information will begin their treatment     with any SSRI or a Dual antidepressant as per the best clinical decision of their treating     psychiatrist. Sexual dysfunction will be identified along the 6 months of active observation.     Psychiatrists will decide to change dose, augment, shift or combine antidepressants at their     clinical discretion in the benefit of their patients and all clinical decisions will be     recorded.Comparisons among antidepressants will be made in terms of their sexual dysfunction     potentiality.   "
207014|NCT00561522|"     The purpose of this study is to determine whether capecitabine is effective to prevent     disease recurrence after curative hepatic resection in patients with hepatocellular     carcinoma.   "
207015|NCT00561535|"     Probiotics may improve symptoms in IBS patients. The aim of this study is to test the     efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome     III criteria.   "
207016|NCT00561548|"     The aim of this research is to study Crohn disease patients before and after anti-TNF, the     cooperation between lamina propria T-lymphocytes and macrophages, through the expression of     co-signalisation molecules and their ligands, the production of cytokines participating in     this cooperation, and the potential role of regulatory T lymphocytes.   "
207017|NCT00561561|"     This study is looking at problems people sometimes have taking in information from their     senses. Specifically, we are comparing the way in which people diagnosed with schizophrenia     process sound information, compared with people who have never been diagnosed with a     psychiatric disorder. When people hear a loud sound they sometimes feel startled, and when     they feel startled they usually blink their eyes. However, if they hear a softer sound     shortly before the loud one they may not blink their eyes - in other words, the eye-blink     response is smaller. When this happens it's called prepulse inhibition of startle. In this     study, we want to measure the startle response and prepulse inhibition of startle in     individuals diagnosed with schizophrenia versus individuals not diagnosed with schizophrenia.     We also want to find out whether people show the same amount of prepulse inhibition of     startle as other members of their family.   "
207018|NCT00561574|"     The current study is a 52-week safety study in elderly outpatients with chronic primary     insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH     900265, MK-8265) to investigate the safety and tolerability of long-term treatment with     esmirtazapine in elderly patients.   "
207019|NCT00561587|"     Due to Quetiapine's particulars and the promising receptor profile, we want to examine the     efficacy concerning relapse prevention of alcoholics suffering from persisting craving and/or     affective symptoms (persisting sleep disorder, persisting excitement, persisting depressive     symptoms, persisting anxiety symptoms) in comparison to matching placebo in a double-blind     pilot study.      We further want to compare the course of the above mentioned craving and affective symptoms     under medication with quetiapine / matching placebo.   "
207020|NCT00561600|"     The primary objective of this investigation is to evaluate the clinical and radiographic     outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a     28mm or 36mm ULTAMET™ metal insert.   "
207035|NCT00561808|"     Retrieval of immature oocytes from women with polycystic ovaries, their in-vitro maturation,     fertilization and embryo transfer can prevent hormonal treatment that can lead to ovarian     hyperstimulation. In addition, it can decrease discomfort and side-effects of routine daily     administration of hormones and it can be cost-effective. Thirty healthy women with Polycystic     Ovarian Syndrome aged 20-35, with BMI 18-30 kg/msq will be included in the study. Their     immature oocytes will be retrieved from small follicles without any hormonal treatment. The     oocytes will be fertilized post in-vitro maturation. The developed embryros will be     transferred to the patients as in a routine IVF cycle.   "
245919|NCT01074346|"     This is an observational study to assess the tolerability of Rebif treatment in Korean     multiple sclerosis (MS) subjects.   "
207021|NCT00561613|"     This was a Phase I multi-center, randomized study in 40 healthy, sexually active women not at     risk for pregnancy due to previous female sterilization. The male partners of the     participants were consented to participate in the study. The clinician evaluating the     cervical mucus for midcycle characteristics and presence of sperm was blinded as to gel used.     The product tested was the SILCS diaphragm with Gynol II (spermicide) and the SILCS diaphragm     with KY Jelly (lubricant). The sequence of diaphragm and gel use was determined by     randomization. The study was conducted at two centers, Magee-Womens Hospital in Pittsburgh,     Pennsylvania and CONRAD's Clinical Research Center at the Eastern Virginia Medical School in     Norfolk, Virginia.      The study consisted of a screening visit, a baseline cycle, and up to 2 cycles of post-coital     tests (PCTs) for a total of 7 visits. The first PCT was a baseline PCT, performed without the     use of any product, in order to demonstrate the subject's ability to produce receptive,     midcycle cervical mucus. The partner's ability to produce motile sperm capable of penetrating     the cervical mucus was evaluated in this cycle. Test PCTs were carried out during the second     and third menstrual cycle using either the SILCS diaphragm with N-9 or the SILCS diaphragm     with lubricant. Cycles were repeated depending on the characteristics of the cervical mucus     and the number of sperm found in the vaginal pool and endocervical specimens; thus, some     women may undergo more than three PCTs. An additional test cycle with a modified polymer     spring device was performed in a subset of participants.      Colposcopy was performed during the mucus check and post-coital test visits in all three     cycles in order to document the baseline condition of the vagina and cervix pre- and     post-intercourse and, in test cycles, to note the effect of product.      Vaginal samples were taken from the posterior fornix of the vagina and the cervical os at     each visit during the baseline and test cycles to measure for the presence of PSA.   "
207022|NCT00561626|"     Rationale: The prevalence of the metabolic syndrome is strongly increasing in developed     countries. The role of the small intestine seems important in the development of the     metabolic syndrome. Although it is known that a high-fat Western-style of diet has     deleterious effects on (post-prandial) lipidemia and glucose homeostases, effects of such a     diet on the small intestine is not known. To elucidate the role of the small intestine on the     early development of the metabolic syndrome, the effects of a high-fat (HF) and a low-fat     (LF) diet will be examined on gene expression in the small intestine and early biomarkers in     blood of healthy subjects.      Objective: The objective of this study is to compare in healthy subjects the effects of a HF     diet (40 En% fat) with those of a LF diet (20 En% fat) on early biomarkers and parameters of     metabolic stress in blood and on expression of genes in the small intestine.      Additional research objectives are:        -  To compare the diet-induced changes in transcriptome profile of the small intestine with          more easily accessible peripheral blood mononuclear cells (PBMC)        -  To establish effects of HF and LF diet on basal gut permeability and after a          chenodeoxycholic acid (CDCA) load (second hit).      Study design: Randomised crossover design. The duration of the experimental periods (HF and     LF diet) will be 28 days, separated by a wash out period of at least 3 weeks. At day 21 of     each intervention period a postprandial test will be performed and duodenum biopsies will be     taken. At day 25 and 28 of each intervention period, respectively, basal gut permeability and     gut permeability after a CDCA load will be determined with a sugar recovery test.      Study population: Ten healthy men in the age of 18-60 years, without a history of any     gastrointestinal disorders or complaints.      Intervention: Subjects will consume in random order:        -  a HF diet (40 En% fat, 45 En% carbohydrates and 15 En% proteins)        -  a LF diet (20 En% fat, 65 En% carbohydrates and 15 En% proteins)      Primary study parameters/endpoints: Potential early biomarkers of the metabolic syndrome in     blood and gene expression profiles in the small intestine.      Secondary study parameters/endpoints: Parameters of the metabolic syndrome in blood, gene     expression profiles in PBMC and gut permeability.   "
207023|NCT00561639|"     A SpetiFast multiplex PCR kit has recently been placed on the market witch can evidence the     DNA of 90% of micro-organisms (bacteria and fungus) implicated in sepsis. However, the     clinical impact of being able to detect the DNA of these various agents is unknown. We     propose to assess the benefit to patient care of the SeptiFast multiples PCR by answering     three questions : 1/in patients with septic immunosuppression, does this kit evidence     etiologic agents not revealed by classical methods? 2/Does the use of PCR results permit     different diagnostic hypotheses to be considered? 3/Does having the SeptiFast results entail     changes to the therapeutic plan?   "
207024|NCT00561652|"     As a needed first step prior to a planned full-scale RCT, in order to assess the feasibility     of the RCT and refine its design and protocols, we will perform a pilot study with the     following objectives:1.To assess whether enough veterans with chronic LBP can be identified,     meet eligibility criteria and be randomized to demonstrate that recruitment for a planned     full-scale RCT is feasible. 2.To assess whether veterans with chronic LBP will adhere to     protocol interventions per study protocol. 3.To assess whether veterans with chronic LBP will     complete data collection per study protocol. 4.To obtain estimates of effect sizes and the     corresponding standard errors of the primary efficacy outcome measures to estimate the     required sample size of a planned full-scale RCT.   "
207025|NCT00561678|"     Elderly patients who undergo anesthesia and non-cardiac surgery are subject to deterioration     of brain function including the development of postoperative delirium (PD) and postoperative     cognitive dysfunction (POCD). These disorders cause disability, distress for both patients     and their families, are associated with other medical complications and account for     significant additional health care costs. We currently use relatively primitive approaches to     preventing and treating PD and POCD.      Dexmedetomidine is a drug used for sedation in critically ill patients that provides some     pain relief and controls the bodies response to stress. The sedation produced by     dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia     and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium     following cardiac surgery and the developing understanding of the causes of PD and POCD     suggest that dexmedetomidine will be particularly effective.   "
207026|NCT00561691|"     Determination of efficiency of nimotuzumab in children with diffuse intrinsic pontine glioma.   "
207027|NCT00561704|"     Insulin resistance typically characterizes type 2 diabetes (T2DM) and prediabetic states and     is the prominent feature of the metabolic syndrome.Adiponectin plays an important part in     glucose metabolism,insulin resistance, the deterioration of renal function.we hypothesize     there is a difference serum adiponectin levels between obese and non-obese women with type 2     diabetic nephropathy. Furthermore, these two groups would respond difference to the RAs     blocker(Losartan).   "
207028|NCT00561717|"     Finding out how fast azelastine nasal spray works in subjects with hay fever.   "
207029|NCT00561730|"     The aim of the study was to evaluate the effect of 7 days treatment with Pantoprazole 40 mg     and 20 mg on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive     gastroesophageal reflux disease) in clinical practice. During the study, the patients had to     complete a short version of a patient-orientated, self-assessed reflux questionnaire     (ReQuest™ in Practice).   "
207030|NCT00561743|"     The purpose of this study is to determine whether doxorubicin HCL liposome injection,     bortezomib, and Dexamethasone in combination, are effective in previously untreated multiple     myeloma patients. Bortezomib inhibits the function of proteasomes, a novel mechanism of     action.   "
207031|NCT00561756|"     RATIONALE: Vaccines made from mouse DNA may help the body build an effective immune response     to kill cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of mouse DNA vaccine     in treating patients with recurrent B-cell lymphoma.   "
207032|NCT00561769|"     Commencing of growth hormone in luteal phase when follicular cohort for the next cycle is     being gathered may increase mature oocytes in poor responder   "
215476|NCT00664287|"     The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on     lowering bad cholesterol and raising good cholesterol.   "
207038|NCT00561860|"     Although continuous positive airway pressure (CPAP) is an effective therapy for obstructive     sleep apnea-hypopnea (OSAH), one of the major impediments to its use is poor compliance.     Adherence with CPAP ranges from 50% to 75%, and subjective reports underestimate actual use.     The primary objectives are to determine whether a remote monitoring system improves 3 month     compliance (average hours of use/night), and reduces the costs of caring for patients with     OSAH who are prescribed CPAP.   "
207039|NCT00561873|"     Determination of efficiency of nimotuzumab in children with high grade glioma.   "
207040|NCT00561886|"     Chronic obstructive bronchitis and emphysema (COPD) are pathophysiologically characterized by     inflammatory and structural changes in the lung. These changes lead to a reduction in elastic     recoil as well as reduction in lung parenchyma. As a consequence collapse of the small airway     occurs during expiration leading to expiratory flow limitation. In severe cases this flow     limitation occurs even during resting condition. This expiratory collapse is suspected to     mask changes in bronchial smooth muscle tone, especially if these changes in bronchial smooth     muscle tone are assessed using expiratory manoeuvres. This might leave the impression of     non-reversible airway obstruction und ineffectiveness of treatment with bronchodilators.     Several studies suggest that in patients with COPD symptomatic changes following application     of a bronchodilating compound do not correlate with changes in forced expiratory volumes. In     contrast inspiratory lung function parameters (especially forced inspiratory volume in one     second (FIV1)) is much more associated with symptomatic changes in patients with COPD.     Comparable effects were also detected regarding peak inspiratory flow (PIF) values.Changes in     inspiratory parameters following administration of a bronchodilator in patients with COPD and     asthma are reproducible. PIF can easily be measured by inspiratory peak flow meters. So far     no data exists on the usability of these devices following bronchodilation in patients with     COPD. Formoterol is a rapid acting bronchodilator, which has been proven save in asthma and     COPD   "
207041|NCT00561899|"     Intermittent preventive treatment (IPT) offers a way of preventing malaria infection without     compromising the development of malaria immunity or encouraging drug resistance. The effect     of IPT in children in the prevention of malaria has been evaluated in a number of trials in     areas of seasonal malaria transmission. Results from these trials have shown that IPTc     provided between 40% - 86% protection against clinical malaria. In 2006, a trial that     compared two methods of IPTc delivery was carried out in Upper River Division, The Gambia.     Preliminary results of the trial have shown that the treatment was very effective as only 4%     (45/1133) of the children seen at the end of year cross-sectional survey were parasitaemic.     Tolerability was assessed in a subset of 1100 children and the results showed that about     13.5% of children developed mild to moderate vomiting. Malaise was present in about 10% of     the study subjects. Severe adverse events were rare. Thus it is important to investigate if     other drug regimens might be equally effective in preventing malaria but less likely to cause     adverse events. During the 2007 malaria transmission season, 1009 children aged 1-5 years     will be individually randomized to receive amodiaquine plus SP, piperaquine plus SP or     Artekin TM (dihdroartemisinin plus piperaquine) at monthly intervals on three occasions     during the months of September, October, and November. To determine the prevalence of side     effects following drug administration participants in each treatment group will be visited at     home three and seven days after each round of drug administration and a side effects     questionnaire completed. To help establish whether these adverse events are drug related, the     same questionnaire will be administered after each treatment round, to 286 age-matched     children who are not part of the trial. The primary ends points will be the incidence of     adverse events.   "
207042|NCT00561912|"     Primary Objective:        -  To determine the progression-free survival (PFS) times for patients with advanced renal          cell carcinoma (RCC) treated with decitabine and interferon alfa-2b.      Secondary Objectives:        -  To determine the toxicity of the combination of decitabine and interferon alfa-2b at the          proposed dose and schedule in patients with advanced RCC        -  To determine overall response by Response Evaluation Criteria in Solid Tumors (RECIST)          criteria for patients with advanced RCC treated with decitabine and interferon alfa-2b.        -  To determine the overall survival times for patients with advanced RCC treated with          decitabine and interferon.        -  To study the effects of decitabine and interferon alfa-2b on DNA methylation and gene          expression in patients' tumor and non-tumor tissues and their correlation with clinical          outcomes.        -  To characterize the modulation of cellular immunity induced by the combination of          decitabine and interferon alfa-2b in patients with advanced RCC and to correlate these          results with clinical outcomes.   "
207043|NCT00561925|"     The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine     extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR)     in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary     objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.   "
207044|NCT00561938|"     Confocal laser endomicroscopy (CLE) is a new diagnostic technique that allows microscopic     examination of the digestive mucosa during ongoing endoscopy. Different types of tissue and     diseases can be diagnosed immediately, and analysis of the in vivo microarchitecture is     helpful to better target standard biopsies and reduce the number of biopsies required. CLE     necessitates an intravenous injection of a fluorescent marker, e.g. fluorescein, to obtain     'optical biopsies' with a high level of magnification (up to 1000 fold). To date, more than     1000 endomicroscopy procedures have been performed in the world and different publications     have shown the safety, feasibility and excellent diagnostic yield of CLE. No complication     related to IV injection of fluorescein has been reported. However, all these data come from a     very limited number of expert centres and need to be confirmed and validated at the     multicenter level. The aims of this multicenter trial are: 1) to standardize CLE in all     centres equipped in France, 2) to ensure the safety of intravenous fluorescein injection, 3)     to test the diagnostic value of CLE in various conditions representative of the large     spectrum of different cancerous and non-cancerous digestive diseases.   "
207045|NCT00561951|"     To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive     bladder.   "
207046|NCT00561964|"     To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with     type Ⅱdiabetes mellitus.   "
207109|NCT00552799|"     To assess whether a period of prophylactic penicillin after an episode of cellulitis of the     leg reduces the risk of repeat episodes. Participants are randomised to receive 12 months of     prophylaxis (penicillin VK 250mg b.d. or placebo). The PATCH I study will recruit only     patients with recurrent disease.   "
207110|NCT00552812|"     The purpose of this study is to determine whether Cheatham Platinum bare metal stents are     safe and effective in the treatment of native and recurrent aortic coarctation in selected     children, adolescents and adults.   "
207047|NCT00551967|"     The specific aim of this proposed study is to conduct a prospective RSA clinical study at     Massachusetts General Hospital involving 50 patients receiving primary total hip     replacements. All patients will receive the vitamin E treated polyethylene acetabular     inserts. Short-term femoral head penetration and long-term steady state wear of the     polyethylene will be measured using both RSA and Martell analysis techniques. Stability of     the acetabular and femoral components will be measured in all patients using RSA analysis.     The stability of the cemented femoral stems will be compared to the stability of the     cementless femoral components as well as to historic data in the literature. In addition, all     patients will complete a self-administered questionnaire to assess the clinical outcome of     the surgery and patient satisfaction.   "
207048|NCT00551980|"     This study is a controlled, cluster randomised, interventional trial to evaluate the     effectiveness of a workplace cognitive and physical program (Intervention), in reducing the     frequency of head and neck pain in an extensive working population.   "
207049|NCT00551993|"     The purpose of this study is to conduct a trial of robotic assisted versus traditional     laparoscopic sacrocolpopexy in the treatment of patients with vaginal prolapse.   "
207050|NCT00552006|"     In the aftermath of traumatic experiences like natural disasters or man-caused traumatic     events, such as war experiences, a substantial part of the affected individuals develop a     number of psychological symptoms. The characteristic symptom pattern occurring in the     aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes     functional impairment of the affected individuals. The investigators want to test whether     Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in     formerly abducted children and youths and former child soldiers, when applied by lay     personnel.   "
207051|NCT00552019|"     The purpose of this study is to evaluate an assessment of the intraocular pressure with the     dynamic contour tonometry and the Goldmann applanation tonometry in patients with active     anterior uveitis.   "
207052|NCT00552032|"     The purpose of this study is to determine whether 8 weeks treatment with mometasone furoate     nasal spray (MFNS), twice daily, is safe and effective in treating adenoid hypertrophy in     children.   "
207053|NCT00552045|"     The purpose of this study is to collect detailed information about the characteristics and     genetics of a large number of individuals with epilepsy.   "
207054|NCT00552058|"     The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing     clinical remission in patients with moderate to severe Crohn's disease as compared with     placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.   "
207055|NCT00552071|"     The purpose of this study is to determine the difference in drug levels of Sandostatin after     IM injection of Sandostatin LAR without ultrasound guidance (as is the standard of care)     compared to drug levels of Sandostatin after IM injection of Sandostatin LAR with ultrasound     guidance in subjects with Acromegaly.   "
207056|NCT00552084|"     Atrial fibrillation (AF) is a heart rhythm disorder that usually involves a rapid heart rate.     People who take fish oil supplements may reduce the risk of a recurrence of AF. This study     will evaluate the effectiveness of fish oil at decreasing the recurrence of AF and will     examine the reasons why fish oil may reduce this risk.   "
207057|NCT00552097|"     The purpose of the study is to determine whether ezetimibe plus simvastatin will be more     effective than simvastatin alone in preventing progression of atherosclerosis of the inner     layer of the carotid artery.   "
207058|NCT00552110|"     The primary objective of this study is to evaluate the efficacy of the combination of     mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once     a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms     including nasal congestion. The secondary objectives of this study are to evaluate the     potential of the combination to produce tachyphylaxis and/or rebound congestion, and to     evaluate the safety of the combination.   "
207059|NCT00552136|"     The purpose of this study is to see if the clinical outcome success rate of Total Ankle     Arthroplasty is similar to that of Ankle Arthrodesis over a period of 10 years. This will     include looking at whether Total ankle arthroplasty results in a lower rate of hindfoot     arthrosis and arthritis after surgery compared to ankle joint arthrodesis and if the rate of     complications and revision surgery is acceptable when compared to Ankle Arthrodesis over a     period of 10 years.   "
207060|NCT00552149|"     A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin     Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.   "
207061|NCT00552162|"     Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert     surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving     area of preclinical research and several groups worldwide are developing this surgical     approach together with industry support. In this new surgical technique, abdominal operations     are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal     cavity instead of incisions on the abdominal wall. NOTES offers all the advantages of     minimally invasive surgery (MIS) and also completely eliminates trauma to the abdominal wall     and the numerous complications of abdominal wall incisions. A NOTES procedure eliminates any     visible scar and could also potentially reduce post operative pain due to the elimination of     abdominal wall trauma.      In this trial we intend to operate healthy women who need to undergo cholecystectomy or     appendectomy. The operations will be performed through the vagina as the access port to the     peritoneum and it will be monitored with laparoscopic vision for safety reasons.   "
207062|NCT00552175|"     The purpose of the study is to determine if duloxetine can help patients with painful     diabetic neuropathy.   "
207063|NCT00552188|"     The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on     vascular inflammation following 24 weeks of dosing.   "
207111|NCT00552825|"     The aim of this study was to investigate the occurrences of respiratory symptoms risk factors     and abnormalities in lung function in young children (3-6 years old) with hemato-oncologic     diseases at presentation (before treatment) and up to 3 years follow-up (study period).   "
207493|NCT00558285|"     An investigational inhalation product (QVA149) for the treatment of patients with Chronic     Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate     the effect on heart rate and cardiovascular effects to ensure the product is safe.   "
207064|NCT00552201|"     Renal transplantation is the treatment of choice of the chronic renal insufficiency arrived     at its final stage. Tacrolimus is an immunosuppressant treatment used for the prevention of     episodes of acute rejection. Tacrolimus is characterized by a narrow therapeutic index and     important interindividual variations of its pharmacokinetic characteristics. Proteins CYP3A4     and CYP3A5 are responsible of intestinal and hepatic metabolism of Tacrolimus. Various     polymorphisms for CYP3A5 and CYP3A4 were described and several retrospective studies     suggested an association between a genetic polymorphism of CYP3A5 and the pharmacokinetic     parameters of Tacrolimus. In particular, we showed that the presence of an allele CYP3A5*1     was associated to the use of more important amounts of Tacrolimus to obtain the desired blood     concentrations.      This study is a national, multicentric, prospective, opened, randomized on two arms of     treatment. 280 receivers of a renal transplant in 12 centres will be included. The genotyping     of gene CYP3A5 will be carried out in the 6 days following transplantation. During the first     week, the patients will be treated by basiliximab, MMF and corticosteroids. They will be     randomized (central randomization) in D6 to receive either Tacrolimus at 0.2 mg/kg/d, or at a     dosage adapted to their genotype. After determination of the first residual blood     concentration of Tacrolimus realized after six oral intakes, the daily amounts of Tacrolimus     could be modified if necessary to reach the desired blood concentrations. The total duration     of the study for a patient is 3 months after transplantation.      The objective of this study is to evaluate the impact of the adaptation, according to the     genotype of the CYP3A5 of the patient, of the first amount of Tacrolimus on the first     residual blood concentration of Tacrolimus, keeping in mind the aim of the individualization     of dosage schedule by pharmacogenetic approach.      Principal criterion : Comparison, between the two groups, of the percentage of patients for     whom the first blood concentration of Tacrolimus evaluated 3 days (D10) after the first     administration of Tacrolimus ranges between 10 and 15 ng/ml.      Statistics will be carried out in intention to treat. The principal criterion will be     analyzed by the test of chi-2.   "
207065|NCT00552214|"     The purpose of this study is to validate the performance characteristics of an assay that     tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration     submission.   "
207066|NCT00552227|"     The purpose of this study is to determine whether ruboxistaurin can reduce blood vessel     inflammation associated with diabetes.   "
207067|NCT00552240|"     The aim of this clinical trial is to compare the efficacy and safety of ritonavir     (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir     disoproxil fumarate (DF).   "
207068|NCT00552253|"     We will study the effect of taking eltroxin at different time, i.e. fasting or postprandial     periods. We will also study the effect of levothyroxin treatment in Chinese people   "
207069|NCT00552266|"     This study will evaluate the safety and effectiveness of methylphenidate in treating     attention deficit hyperactivity disorder (ADHD) in children with both ADHD and     trichotillomania.      Trichotillomania is an impulse control disorder. There is growing evidences of the     involvement of dopaminergic neurotransmission in the pathophysiology of trichotillomania.     Reported increase in the prevalence of ADHD among patients with impulse control disorders,     such as pathological gambling as well as trichotillomania, may result from the overlapping     pathophisiological background. It is hypothesized that in cases of ADHD comorbid with     trichotillomania methtylphenidate treatment will exhibit beneficial effects in both the ADHD     and the hair pulling.   "
207070|NCT00552279|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and     safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an     alternative dosing schedule as compared to the standard dosing schedule in young female     subjects aged 15 - 25 years. The Protocol Posting has been updated in order to comply with     the FDA Amendment Act, Sep 2007.   "
207071|NCT00552292|"     The study in aimed to investigate epidemiology of risk factors in Russian Federation its     prognostic value aimed on acceptance of national specific definition of metabolic syndrome     and guidelines for its management.   "
207072|NCT00552305|"     The purpose of this trial is to determine whether lacosamide is safe and effective for     long-term use in patients with partial-seizures from epilepsy.   "
207073|NCT00552331|"     The purpose of this study is to determine whether the rate of fracture healing and fracture     union, repaired with the LISS device, will be as good as or better than the usual fracture     fixation systems.   "
207074|NCT00552344|"     The primary objective of the study is to assess the safety of long term therapy with     Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].   "
207075|NCT00552357|"     Primary graft dysfunction (PGD) is a severe lung complication that can occur in the days     after lung transplant surgery. This study will analyze blood samples to determine if high     levels of certain chemicals may increase the risk of developing PGD after a lung transplant.   "
207076|NCT00552370|"     To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®,     each of varying intensity and defined by their end-of -study target for self monitored plasma     glucose(SMPG), in patients with Type 2 diabetes mellitus, with inadequate glycemic control     (A1C greater than or equal to 7.0%) on oral antidiabetic drug therapy(OAD).   "
207077|NCT00552383|"     NIDCAP based developmental care is a method of looking after preterm infants that is guided     by the infant's behavioural cues, and that actively involves parents in the care of their     infant. There is limited evidence that outcomes for infants are improved if they receive     NIDCAP based care. This study evaluates the effects of introducing NIDCAP based care to a     level III neonatal intensive care unit, in the post - surfactant era, and also evaluates its     effects on developmental outcomes at age 18 months.   "
207078|NCT00552396|"     Development of new treatments for diseases such as multiple myeloma is a focus for research.     The research being conducted is on treatment called Anti-KIR (1-7F9), which activates the     body's own cells to kill tumor cells. This is different from many other treatments where     chemicals are given to kill tumor cells. The purpose of the study is to determine a safe dose     of Anti-KIR (1-7F9) to administer in humans and to gain information about its effectiveness     in the treatment of multiple myeloma.   "
207079|NCT00552409|"     This study will assess the effects of vitamin D3 supplementation (cholecalciferol; 2000 IU     daily) on serum calcium levels, circulating vitamin D levels, and markers of kidney disease     and cardiovascular risk among people with diabetes mellitus and early kidney disease.     Eligibility criteria include type 2 diabetes and stage 1-2 chronic kidney disease, defined by     a urine albumin-creatinine ratio 30-300 mg/g and an estimated glomerular filtration rate ≥ 60     mL/min. Participants will be randomly assigned to treatment with vitamin D3 or placebo, each     taken by mouth once daily for a study duration of one year. Study medications will be added     to standard treatment, including an angiotensin converting enzyme inhibitor and/or     angiotensin II receptor blocker. We hypothesize that vitamin D3, compared with placebo: (1)     is well-tolerated and safe among people with diabetes and kidney disease; (2) results in     adequate attained circulating vitamin D levels; and (3) positively affects markers of kidney     disease and cardiovascular risk.   "
207081|NCT00552435|"     Objective: To compare micropulse 810nm diode laser photocoagulation versus argon laser     photocoagulation for treatment of diabetic macular edema. Micropulse laser technique will be     determined by an initial clinical trial comparing single versus double density laser     photocoagulation techniques for treatment of diabetic macular edema.The single density is     based on the Early Treatment Diabetic Retinopathy Study (ETDRS) grid photocoagulation     technique and the double density increases the number of spots.      Methods: Patients with diabetic macular edema will be assigned to receive either micropulse     810nm diode laser photocoagulation or argon laser photocoagulation therapy. First, in a     smaller clinical trial, patients will be assigned to single or double density micropulse     810nm diode laser to determine best strategy for this therapy. Visual acuity, fundus     photographs and fluorescein angiography, and optical coherence tomography measurements ,     autofluorescence and mfERG were obtained at baseline and at 1, 3 and 6 months and 12 months.   "
207082|NCT00552448|"     Asthma is a disease resulting in mucus hypersecretion and airways obstruction. This causes     difficulty breathing. The High Frequency Chest Compressor (HFCC) is a device that has been     shown to decrease respiratory complications in individuals with severe disability who are     unable to clear airway secretions. There is a lack of studies using this device in children     with asthma. The device has been shown in a study to be safe in children with asthma. The     investigators propose that using this device in our pediatric patients hospitalized in the     pediatric ICU with asthma will result in decreased pediatric ICU stay. The investigators will     also look at asthma severity, total days of hospital stay and chest discomfort while on     therapy.   "
207083|NCT00552461|"     The purpose of this study is to determine whether the use of rituximab is effective in     treating pulmonary alveolar proteinosis by leading to an improvement in lung function and     disease status.   "
207084|NCT00552474|"     The purpose of this study is to evaluate the safety and efficacy of bilateral stimulation of     the subthalamic nucleus (STN) of the brain when using the ANS Totally Implantable Deep Brain     Stimulation System as an adjunctive treatment for reducing some of the symptoms of     Parkinson's Disease that are not adequately controlled with medication.   "
207085|NCT00552487|"     The purpose of this study is to determine whether patients with Hashimoto thyroiditis and     impaired well-being may have a partial secondary adrenocortical insufficiency.   "
207086|NCT00552500|"     This project aims to a) evaluate the effects of haloperidol, olanzapine, and risperidone in     combination with valproate on insulin secretion and insulin actions, b) evaluate medication     effects on abdominal fat, total body fat and total fat-free mass, and c) evaluate treatment     effects on glucose tolerance, lipid profiles, and plasma levels of leptin, adiponectin,     ghrelin and C-reactive protein. Hypotheses will be evaluated by measuring 1) insulin action     and secretion using frequently sampled intravenous glucose tolerance tests, 2) body     composition using dual energy x-ray absorptiometry, magnetic resonance scans, and     anthropomorphic measurements, and 3) changes in hormone levels and lipid profiles. The aims     will be addressed in non-diabetic schizophrenia patients chronically treated with     haloperidol, olanzapine or risperidone who will have valproate added to their treatment.     Relevant data is critically needed to target basic research, identify long-term     cardiovascular risks, and plan therapeutic interventions.   "
207087|NCT00552513|"     The timing of intervention study is a prospective, randomized, international, multicentre     comparison of the relative efficacy, safety, and cost effectiveness of a management strategy     of coronary angiography and intervention performed within 24 hours of randomization versus     delayed coronary angiography and intervention in patients after 36 hours with acute coronary     syndromes (ACS).   "
207088|NCT00552526|"     This is an open randomized controlled study in children with mental retardation and     refractory epilepsy in which treatment with ketogenic diet (KD) is compared with treatment     with the antiepileptic drug (AED), not tried by the patient before, which we consider to be     the most appropriate AED for the patient.   "
207089|NCT00552539|"     The objective of this study is to determine whether the Syphilis and Men educational video     can be a useful tool to increase syphilis knowledge and testing among English and     Spanish-speaking urgent care and emergency department patients, regardless of various     self-reported characteristics that increase their risk for syphilis infection.   "
207090|NCT00552552|"     The objective of this study is to develop a structured and evidence-based self-management     program to cope with cancer-related fatigue and to assess the efficacy of the intervention in     cancer survivors.   "
207091|NCT00552565|"     The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in     the treatment of IBS-D.   "
207092|NCT00552578|"     This study is designed to determine if different doses of buprenorphine (either tapering     doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who     also are addicted to opiate pain medicines.   "
207093|NCT00552591|"     Background: Family members (spouses, siblings, offspring) of patients with coronary heart     disease (CHD) may themselves be at increased risk for developing CHD for genetic, biochemical     and/or behavioural reasons. Targeted approaches aimed at family members of those with     established CHD may be a cost-effective way to identify high-risk persons and link them to     effective risk factor modification. During pilot testing we found 29% of family members of     patients recently hospitalized at our institution had ≥ 3 CHD risk factors. Encouragingly,     they indicated high levels of readiness to change underlying risk behaviours such as     cigarette smoking and physical inactivity. We have developed a 12-week family heart health     program featuring a personal plan for achieving risk factor goals and weekly contact with a     heart health educator. This intervention needs to be fully tested.      Research Aims:      In this study, we will:        1. Compare the effects of a targeted family heart health (FHH) screening, counselling and          follow-up program versus usual care (UC) for reducing participants total          cholesterol/high density lipoprotein (TC/HDL) ratio 52 weeks after program entry, in          family members of patients recently hospitalized with CHD;        2. Compare the effects of the FHH program versus UC on modifiable components comprising the          Framingham score, including: smoking status; systolic blood pressure; total cholesterol;          and high density lipoprotein cholesterol;        3. Compare the effects of the FHH program versus UC on: lifestyle-related factors (dietary          patterns, leisure time exercise, body composition); medication use (anti-lipemic          medications, anti-hypertensive medications, pharmacotherapies for smoking cessation);          and use of healthcare resources (physician visits, hospitalization days, number of          laboratory and diagnostic tests and procedures).   "
207129|NCT00553059|"     The goal of this clinical research study is to learn if adding dronabinol in combination with     the standard of care (dexamethasone and palonosetron) can better help to control nausea and     vomiting in patients receiving chemotherapy. The safety of the drug combinations will also be     studied.   "
207094|NCT00552604|"     Study Objectives: To determine the efficacy and safety of a standardised extract of Cannabis     sativa given orally 2 times daily as compared to placebo for the relief of muscle stiffness     and pain in multiple sclerosis for a period of 12 weeks.      Study Patients: 400 patients with multiple sclerosis (age 18-64, stable disease during     previous 6 months, ambulatory or not, antispasticity medication and physiotherapy stabilised     ≥ 30 days) with experiencing muscle stiffness ≥ 4 on a 11-point numerical Likert scale at     baseline.      Study treatment:      Group 1: Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing     between 5 mg and 25 mg THC/d, administered twice daily, additionally to previous     antispasticity and analgesic medication.      Group 2: Matched placebo, twice daily, additionally to previous antispasticity and analgesic     medication.      Treatment Schedule: Start dose 5 mg THC/d, individual dose titration with increase of 5 mg     THC every 3 days, maximal total daily dose 25 mg THC, administered as 2 equal doses based on     tolerability. Treatment duration: 12 weeks.      Study sites: 20 neurological clinics in the United Kingdom.   "
207095|NCT00552617|"     The objective of the trial was to establish the dose-response relation of Org 25969 given as     a reversal agent of rocuronium or vecuronium at reappearance of T2 during sevoflurane     anesthesia for Caucasian subjects.   "
207096|NCT00552630|"     Childhood Lead Poisoning is a widespread disease that has few effective treatments. The     specific aims of this proposed clinical trial are threefold:        -  To determine whether a six-week course of a newly formulated d-penicillamine suspension          will effectively reduce blood lead level in children aged 6 months to 16 years with          blood lead levels of 15-25 μg/dL.        -  To determine whether d-penicillamine chelation produces a sustained reduction in blood          lead level in comparison with succimer and other lead chelators which always produce a          significant post-treatment rebound.        -  To determine whether chelation with d-penicillamine improves the physiologic          disturbances that can be measured in children with blood lead levels in this range.   "
207097|NCT00552643|"     The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline     in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic     chronic wounds with different etiologies including wounds with exposed bone and/or tendons.   "
207098|NCT00552656|"     The purpose of this study is to investigate the long term efficacy and safety of firebird     sirolimus-eluting stent for treatment of complex coronary Lesions.   "
207099|NCT00552669|"     In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare     metal stent implantation alone demonstrated at one year of follow up a significant reduction     of angiographic and clinical parameters of restenosis (ANMAT resolution number 3366 from June     2004 and Rodriguez A et al JACC,2006,47,1522-1529). In addition previous reported registries     from our group with Drug Eluting Stents showed similar amount of reduction in clinical     parameters (not angiographic)of restenosis (ERACI III, Rodriguez A et al EuroIntervention     2006,2:53-60). Taking in account that 8.3% of patients treated with oral rapamycin plus Bare     Metal Stents(ORAR II Trial JACC 2006)and 8.8% of patients treated with DES developed clinical     restenosis (ERACI III Registry, EuroIntervention 2006) the investigators sought to compare     differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of     follow up assuming that safety and efficacy clinical end points would be similar.   "
207100|NCT00552682|"     The purpose of this study is to compare duloxetine with conventional treatment of pain in     HIV-1 infected patients.   "
207101|NCT00552695|"     This study will determine whether application of a patch containing a topical anesthetic     (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an     intravenous catheter in Emergency Department patients.   "
207102|NCT00552708|"     This study will be a randomized study investigating the bioequivalence of COREG CR to its     components, COREG and Lisinopril (ZESTRIL). PK samples will be obtained throughout the study     to investigate the PK of COREG CR FDC to COREG and Lisinopril   "
207103|NCT00552721|"     It is the primary purpose of this pilot study to investigate if physical therapy with     strength training is better at improving muscle and gait function after anti-spastic     treatment with Botulinum toxin compared to physical therapy without strength training in     children with cerebral palsy. The investigators hypothesize that it is.   "
207104|NCT00552734|"     140 subjects will be enrolled into the clinical study and randomized into the Control Group     or the Experimental Group by block randomization. The subjects must meet all inclusion and     none of the exclusion criteria. Each subject will have 7 clinic visits and 3 phone visits.     The Baseline Visit will consist of a complete history, vitals, a physical examination and     completion of the consent and screening process. All clinic visits, except for the Baseline     Visit will include meter/PDA download. In addition, meter education will be provided to all     subjects, and PDA education will be provided to the Experimental group at the Baseline Visit     and 2-Week Visit as needed to ensure subject understanding. The phone visits will consist of     a history including any changes in insulin dose, and any hypoglycemic events, hyperglycemic     events, or other adverse events that have occurred since the last clinic visit.      The primary endpoint in this study was to show a reduction in A1c of at least 0.4% or higher     in the insulin guidance software group at 6 months and/or 1 year.   "
207105|NCT00552747|"     Fenofibrate is a drug that acts on the PPAR alpha receptors, increasing HDL-cholesterol and     decreasing triglyceride levels. The interaction with these receptors has antiatherogenic     actions by regulating the expression con key proteins that participate in vascular     inflammation, plaque stability and thrombosis.      Fenofibrate reduces triglycerides and increases HDL-C in plasma. It also decreases small,     dense LDL particles. The use of this drug has resulted in improvement of vascular function     measured by endothelial function. Our hypotheses state that fenofibrate will improve:     endothelial function, improve HDL antioxidant capacity and size distribution towards a     predominance of small HDL particles.   "
207106|NCT00552760|"     The purpose of this study is to determine whether treating sleep difficulties in patients     with bipolar disorder also improves their mood stability.   "
207107|NCT00552773|"     To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to     placebo in subjects with acute sinusitis   "
207108|NCT00552786|"     This study will examine whether oral intake of 1200mg N-Acetylcysteine/day will prevent     temporary threshold shift in hearing among workers exposed to noise   "
207112|NCT00552838|"     Multidisciplinary antimicrobial utilization teams (AUT) have been proposed as an effective     mechanism for improving antimicrobial use, but data on their efficacy remain limited. The     researchers postulated that a multi-disciplinary AUT would improve antimicrobial use in a     teaching hospital when compared to the standard of care (no AUT intervention).      Design: Randomized-controlled intervention trial. Setting: A 953-bed urban teaching hospital.      Patients: Patients admitted to internal medicine ward teams who were prescribed selected     antimicrobial agents (piperacillin-tazobactam, levofloxacin, or vancomycin) during the     10month study period.      Intervention: Eight internal medicine ward teams were randomized monthly to academic     detailing by the AUT while 8 internal medicine ward teams were randomized indication-based     prescription of broad spectrum antimicrobials.      Measurements: Proportion of appropriate empiric, definitive, and end antimicrobial usage     (antimicrobial use from the initiation of therapy until definitive therapy is prescribed).   "
207113|NCT00552851|"     The purpose of this study is to evaluate changes in left ventricular mass and cardiac     function in patients with active acromegaly before and after treatment with the growth     hormone receptor antagonist pegvisomant for one year.   "
207114|NCT00552864|"     In High Thoracic Epidural Anesthesia (HTEA) the use of a local anesthetic (LA) with low     cardiac toxicity is crucial as myocardial contractility is often already seriously impaired.     The aim of this study is to compare the efficacy, doses and side effects of ropivacaine and     levobupivacaine in patients submitted to coronary artery bypass graft with HTEA and general     anesthesia. The primary end point is the amount of LA drug required to maintain a VAS < 4     when coughing in the first 24 postoperative hours.   "
207115|NCT00552877|"     In a randomized study the Xience V coroary artery stent may be non inferior to the Cypher     Select+ coronary stents in the treatment of unselected patients with coronary artery disease.   "
207116|NCT00552890|"     This randomized control trial compared the influence of an Atkins diet to that of the ADA     recommended diet on Type 2 diabetic obese patients during a one-year follow-up period   "
207117|NCT00552903|"     A randomised trial with individual patients as units of observation will be carried out.     Health coaching is used to modify health behaviour and thus improve disease control and     health status, as well as use of health care services. A personal health coach is assigned to     each patient and they are in weekly contact through telephone. The intervention lasts for 12     months. No intervention is offered to the patients in the control arm.   "
207118|NCT00552916|"     The purpose of this study is to determine if a form of exercise,known as electrical     stimulation can improve walking function and other important health outcomes. The hypothesis     is that electrical stimulation can enhance the ability to walk for stroke survivors who are     unable to walk on their on their own.   "
207119|NCT00552929|"     The objective of the trial was to establish the dose-response relation of Org 25969 given as     a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane anesthesia for     Caucasian subjects   "
207120|NCT00552942|"     To see if removing the omentum in addition to a gastric bypass improves diabetes is better     than just a gastric bypass.   "
207121|NCT00552955|"     This study will examine the effect of fasting on lymphangioleiomyomas abdominal tumors formed     from enlarged lymph nodes containing lymphatic fluid. Previous studies have determined that     these tumors increase in size in the evening, but this result could stem from the fact that     previous study participants were tested after eating lunch. The purpose of the study is to     help researchers understand the factors that produce changes in size of lymphangioleiomyomas,     as well as to improve the ability of medical professionals to diagnose lymphangioleiomyomas     and avoid confusing these tumors with other malignant tumors.      Volunteers must be women who are at least 18 years of age and who have been diagnosed with     lymphangioleiomyomas in the abdominal or pelvic areas. Candidates who have had lung or kidney     transplants or who have type 1 diabetes will be excluded. Candidates will be screened with a     physical examination and medical history.      During the study, participants will be admitted to a National Institutes of Health clinical     center for three days to undergo a number of tests. Tests will include routine blood and     urine tests, and electrocardiogram, research blood testing, and abdominal and pelvic     ultrasounds.   "
207122|NCT00552968|"     The incidence of pain in the post traumatic population is an area that has little to no     investigation. This study seeks to determine the incidence and experience of pain in this     vulnerable population at different time points - while in hospital, 4 weeks post injury, 3     months post injury.   "
207123|NCT00552981|"     In a randomized controlled trial, the investigators include patients with beginning symptoms     of a common cold and compare two interventions:        1. the inhalation of warm air for inducing a warming of the throat and        2. the inhalation of ambient air as control. As outcome the effect on symptoms and duration          of the common cold will be assessed. The interventions will consist of visits with a          duration of 2-3 minutes on three following days in a Finnish sauna. Patients will be          fully dressed.   "
207124|NCT00552994|"     In stent neointimal hyperplasia may be less in the Cypher select plus stent compared to the     Xience V stent in diabetic patients.   "
207125|NCT00553007|"     Periodontal disease is associated with the components of Metabolic syndrome, such as obesity,     diabetes, hypertension and hyperlipidemia. Therefore, strong relation with periodontal     disease and metabolic syndrome is suggested. the overall goal of this study is to define the     relation between periodontal disease and metabolic syndrome, including atherosclerosis.   "
207126|NCT00553020|"     To assess the duration of the metabolic effect of a sc injected single dose of either insulin     glargine (LantusT) or NPH-insulin (ProtaphanT) on blood glucose control in patients with type     2 diabetes   "
207127|NCT00553033|"     The aim of this study is to evaluate the feasibility and safety of laparoscopic liver     surgery.   "
207128|NCT00553046|"     To verify with a specific questionnaire, the families' perceived quality of end-of-life care     and of dying in the last 3 months of life of 168 patients (Chronic Obstructive Pulmonary     Disease-Amyotrophic Lateral Sclerosis (ALS)-Restrictive disorders-Neuromuscular disease-     others) with chronic respiratory failure needing domiciliary mechanical ventilation (MV).   "
207130|NCT00553072|"     Magnesium sulphate has been shown to be neuroprotective. The investigators hypothesize that     magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in     the immediate neonatal period.   "
207132|NCT00553098|"     This phase II trial studies fludarabine phosphate and total-body irradiation with or without     alemtuzumab followed by donor stem cell transplant to see how well it works in treating     patients with immunodeficiency or other nonmalignant inherited disorders. Giving     chemotherapy, such as fludarabine phosphate, a monoclonal antibody such as alemtuzumab, and     radiation therapy before a donor stem cell transplant helps stop the growth of abnormal     cells. It may also stop the patient's immune system from rejecting the donor's stem cells.     The donated stem cells may replace the patient's immune cells and help destroy any remaining     abnormal cells.   "
207133|NCT00553111|"     During the winter of 2007, the Syphilis Advisory Group and Bureau of STD Control of the NYC     Department of Health funded the Emergency Department of Jacobi Medical Center to further     evaluate the effectiveness of the Syphilis and Men video in additional settings where men     access STD related information and testing and where high-risk groups, such as MSM, frequent.     The video was evaluated for promoting knowledge of syphilis, especially as facilitator of HIV     transmission, and in encouraging concurrent testing (syphilis and HIV) among men recruited     from a community-based organization, an ambulatory care setting, and a dance club.   "
207134|NCT00553124|"     RATIONALE: Studying different factors that effect patients with newly diagnosed bladder     cancer may help doctors learn more about the disease, improve the ability to plan cancer     treatment, and help patients live more comfortably.      PURPOSE: This clinical trial is studying different factors affecting patients with newly     diagnosed bladder cancer.   "
207135|NCT00553137|"     A prospective randomized double blinded placebo controlled comparative trial will be     performed at HIV clinic of the Muhimbili National Hospital/MUCHS where 220 HIV positive     patients presenting with oropharyngeal candidiasis (OPC) on antiretroviral (ARVs) treatment     or not will be included.      The aim of this study is to compare the efficacy and safety of single dose fluconazole     (750mg) and two weeks course of fluconazole (150mg once daily)in the treatment of OPC in HIV     positive patients. It is hypothesised that the two regimens are equally effective in the     treatment of OPC.   "
207136|NCT00553150|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking some of the blood flow to the tumor. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving everolimus together with temozolomide and     radiation therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when     given together with temozolomide and radiation therapy in treating patients with newly     diagnosed glioblastoma.   "
207137|NCT00553163|"     There is increasing evidence that worsening of ulcerative colitis (UC) can be provoked by     psychological stresses. As yet, there have been no proper scientific studies to find out     whether stress reduction can improve the course of UC. Hypnotherapy is a technique by which a     practitioner induces a temporary trance-like state in patients: while they are in this state,     the practitioner uses suggestion to induce relaxation as well as beneficial modification of     the way in which the patient experiences the gut working. In previous studies in our lab, we     have shown that a single 50 minute session of hypnosis can reduce special indicators of     inflammation both in the blood-stream and in the lining of the lower bowel (rectum). Further     more, in earlier work by others, hypnosis has been shown to be effective in the treatment of     patients with irritable bowel syndrome, duodenal ulcer and indigestion unassociated with     ulcers.      Many patients with UC need to take the immunosuppressive drug, azathioprine, in addition to a     5ASA drug, to keep their disease under control. While azathioprine is usually effective in     maintaining remission of UC, it does require regular drug checks and carries the risk of     possible side-effects. We now plan to undertake a study of hypnotherapy to see whether it can     prevent relapse (worsening) of UC in patients who normally need to take azathioprine to keep     their UC inactive. To do this, we shall ask 66 patients who agree to participate in the trial     to stop their azathioprine. They will then be allocated to receive either gut-focussed     hypnotherapy (44 patients) or, as a control, non-emotive educational sessions (22 patients)     once a month for 3 months, with intervening self-hypnosis daily in the active arm. We shall     then record the numbers of patients in each group who develop relapse of their UC after 6     months and after a year. We shall diagnose relapse from patients' own diaries recording     diarrhoea and bleeding, and by sigmoidoscopy. As part of these studies, we shall also do     particular blood tests and take specimens from the lining of the rectum during the     sigmoidoscopy to assess by special laboratory testing how hypnotherapy might be working to     reduce inflammation in the bowel.      It is hoped that this clinical trial will identify a new drug-free way of reducing the     chances of relapse in patients with UC. It should also shed further light on the ways in     which the brain can affect the function of the inflamed bowel   "
207138|NCT00553176|"     The purpose of this study is to evaluate the long-term clinical, economic and humanistic     outcomes of various treatment regimens, including infliximab, in Crohn's disease in real     world medical practice.   "
207139|NCT00553189|"     Background:        -  PARP is an enzyme that is involved in the repair of damage to DNA. Levels of the enzyme          are higher in tumor cells than in normal cells, and may play a part in resistance to          cancer chemotherapy and radiation therapy. ABT-888 is an experimental drug that inhibits          PARP and may help to increase the effectiveness of cancer treatments designed to damage          DNA in cancer cells.        -  Topotecan is a drug approved by the Food and Drug Administration for treating certain          cancers.        -  This dose escalation study will test the two drugs at successively higher doses in small          groups of patients until the highest safe dose is determined.      Objectives:        -  To test the safety of the combination of ABT-888 and Topotecan (TPT) and determine the          highest dose of each drug that can be safely given to humans. This is the maximum          tolerated dose (MTD).        -  To learn how the combination of ABT-888 and TPT works in humans and how the body handles          the drugs.        -  To determine the side effects of the combination of ABT-888 and TPT at the tested doses.      Eligibility:      -Patients with solid tumors, lymphomas and chronic lymphocytic leukemia whose disease has     progressed following standard therapy or for whom standard treatments are not available.      Design:        -  ABT-888 and TPT are given in 21-day treatment cycles. At the start of the study, TPT is          infused through a vein over 30 minutes about a week before cycle 1 starts. Starting on          day 1 of cycle 1, ABT-888 is given by mouth twice a day for 7 days. TPT is given through          a vein daily for 4 days starting on day 2. After the last dose of ABT-888 day 7, no more          treatment is given for the rest of the 21-day cycle.        -  For the remaining cycles, ABT-888 is given twice a day by mouth on days 1 to 7 of each          cycle, and TPT is given through a vein daily on days 1 to 5 of each cycle.        -  The first three to six patients enrolled in the study take the smallest study dose of          the drugs. If they do not develop significant adverse side effects, successive small          groups of patients take the drug at increasingly higher doses until the MTD is reached.          Additional patients enrolled receive the MTD.        -  Patients have periodic clinic visits for their TPT infusions and for tests and          examinations. Evaluations include measurement of vital signs, physical examinations,          blood and urine tests, electrocardiograms and CT or other imaging tests, such as          ultrasound or MRI. Tumor biopsies may be requested to study the effects of the drugs on          the...   "
207170|NCT00553592|"     To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with     placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of     pain intensity) associated with diabetic periperal neuropathy in adult outpatients.      To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens     treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral     neuropathy.   "
207171|NCT00553605|"     This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled     trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib     40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in     outpatients presenting at emergency room settings. This trial is designed to show     non-inferiority of parecoxib related to ketoprofen.   "
207140|NCT00553202|"     RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that     closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving antithymocyte globulin before     transplant and cyclosporine, tacrolimus, and methotrexate before and after transplant may     stop this from happening.      PURPOSE: Natural Killer (NK) cells from the donor's bone marrow may be important in fighting     leukemia. Bone marrow donors can be selected based on the type of NK cells they have,     specifically the killer immunoglobulin receptor (KIR) type. This study provides information     on KIR type from potential donors, which can be used in selecting the bone marrow donor. This     phase II trial of unrelated donor stem cell transplant in patients with high risk AML     (monosomy 7, -5/5q-, high FLT3-ITD AR, or refractory or relapsed AML) in which KIR typing of     the patients and potential donors will be available to the treating transplant physician at     the time of donor selection.   "
207141|NCT00553215|"     RATIONALE: Studying quality of life in patients with bladder cancer may help determine the     long-term effects of bladder cancer and may help improve the quality of life for patients in     the future.      PURPOSE: This clinical trial is studying quality of life in patients with bladder cancer.   "
207142|NCT00553228|"     The purpose of this study is to assess whether immunization against pertussis in the mid     third trimester of pregnancy provides passive protection to the infant by transfer of IgG     transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk,     sufficient to protect the infant against pertussis disease in the critical neonatal period,     without suppressing the infant's immune response to active immunization and disease   "
207143|NCT00553241|"     The purpose of this study is to determine whether the ABCD2 score can be used in patients     with transient ischemic attack, admitted to Beijing anzhen hospital, to evaluate the     prognosis, risk factor of those patients.   "
207144|NCT00553254|"     To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.   "
207145|NCT00553267|"     The primary objective of this trial is to demonstrate that the fixed dose combination of     telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan     80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks     compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks     treatment with A10.   "
207146|NCT00553280|"     The purpose of this study is to assess the safety and efficacy of the long-term use of     pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy     who have completed 13 weeks of dosing in Study A0081163   "
207147|NCT00553293|"     To study whether addition of human LH hormone (Luveris) during the final days of stimulation     with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for     patients undergoing in vitro fertilisation.   "
207148|NCT00553306|"     RATIONALE: Laboratory-treated T cells may be able to kill tumor cells when they are put back     into the body. Aldesleukin and cyclophosphamide may stimulate the immune system in different     ways and stop tumor cells from growing. Giving laboratory-treated T cells together with     aldesleukin after cyclophosphamide may be an effective treatment for melanoma.      PURPOSE: This phase I/II trial is studying the side effects of giving laboratory-treated T     cells together with aldesleukin after cyclophosphamide and to see how well they work in     treating patients with stage IV melanoma.   "
207149|NCT00553319|"     The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the     safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine     dependence. Since this medication has independently shown promise in helping with ADHD and     cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD     and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives     of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and     improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.   "
207150|NCT00553332|"     This phase II trial is studying how well selumetinib works in treating patients with biliary     cancer that cannot be removed by surgery. Selumetinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
207151|NCT00553345|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of selenium and vitamin E may stop cancer from growing or coming back.      PURPOSE: This randomized phase III trial is studying giving selenium together with vitamin E     to see how well it works compared with a placebo in preventing cancer progression and     recurrence in patients with early-stage bladder cancer.   "
207152|NCT00553358|"     This is a randomised, open label multicenter Phase III study comparing the efficacy of     neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant     lapatinib and trastuzumab plus paclitaxel given as neoadjuvant treatment in HER2/ErbB2     over-expressing and/or amplified primary breast cancer.      Patients will be randomised to receive either: lapatinib 1500 mg daily, trastuzumab 4 mg/kg     intravenous (IV) load followed by 2 mg/kg IV weekly, or lapatinib 1000 mg daily with     trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for a total of 6 weeks. After this     biological window, patients on monotherapy arms will continue on the same targeted therapy     plus weekly paclitaxel 80 mg/m^2 for a further 12 weeks, up to definitive surgery. In the     combination arm, patients will receive lapatinib 750 mg daily in combination with trastuzumab     2 mg/kg IV plus weekly paclitaxel 80mg/m^2 IV for a further 12 weeks, up to definitive     surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with     5-Fluorouracil Epirubicin Cyclophosphamide (FEC) followed by the same targeted therapy as in     the biological window of the neoadjuvant setting for a further 34 weeks (in the combination     arm, lapatinib dose will be 1000 mg daily in combination with trastuzumab). The planned total     duration of the anti-HER2 therapy will be one year.   "
207153|NCT00553371|"     RATIONALE: Learning about long-term effects in patients with testicular cancer may help     doctors plan better treatment and follow-up care.      PURPOSE: This clinical trial is using CT scans to follow patients who have been treated for     metastatic testicular cancer.   "
246575|NCT01079117|"     To compare the effectiveness of slow release oral morphine treatment in patients that     previously have been treated with methadone   "
207154|NCT00553384|"     The reason for doing this research is to understand why different people show different     responses when they smell an odor called androstadienone. Androstadienone is a chemical found     in male sweat. Other studies have shown that smelling this chemical can cause people to     experience sweating, changes in skin temperature, and changes in a stress hormone call     cortisol. These responses, which are called physiological effects, are stronger in some     people than in others.      We are interested in finding out whether these individual differences are genetic, that is     caused by differences in our genes. Humans have about 1000 genes for odorant receptors. These     are the molecules that bind and detect odor molecules in our nose and allow us to respond to     so many different odors. It has been shown that some of these genes exist in two forms: a     functional one and one that has been mutated and is therefore no longer functional.      We think that people who do not respond to a specific odor may carry the non-functional form     of the gene for the receptor that detects the odor molecule. To test this idea we want to     find people who respond strongly to a specific smell, and compare their odorant receptor     genes with those of people who respond weakly to the odor.   "
207155|NCT00553397|"     The use of live donors for solid organ transplantation has increased the number of available     organs for those waiting for a transplant. Donation of an organ may have significant effects     on a donor's health. This study will determine the baseline characteristics, early     postoperative morbidity, and long-term survival for participants who underwent donor     lobectomy between 1993 and 2006.   "
207156|NCT00553410|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast     cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen     of letrozole is more effective in postmenopausal women who have received hormone therapy for     early-stage breast cancer.      PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in     preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for     hormone receptor-positive, lymph node-positive, early-stage breast cancer.   "
207157|NCT00553423|"     To evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy     (HE) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients   "
207158|NCT00553436|"     The purpose of this study is to show that the surgical site in the bowel wall can be sewn     closed in the colon or intestine, with a new sewing device after removal of a benign polyp     according to standard of care.   "
207159|NCT00553449|"     The purpose of this study is to evaluate the effect of each of the rabeprazole treatment     regimens on nocturnal heartburn symptoms.   "
207160|NCT00553462|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy     x-rays to kill tumor cells. Erlotinib may make tumor cells more sensitive to radiation     therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation     together with radiation therapy and erlotinib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel     albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib     works in treating patients with stage III non-small cell lung cancer that cannot be removed     by surgery.   "
207161|NCT00553475|"     To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in     patients with painful diabetic peripheral neuropathy.   "
207162|NCT00553488|"     This study is to determine the effect of intra-dermal (ID) administration of regular and of     rapid-acting insulin, before eating, on blood glucose levels for several hours after a     standard meal (a mixed, liquid meal). Insulin will also be given normally, subcutaneously,     for control or comparison purposes. The hypothesis or expectation is that ID insulin will     work more quickly and control blood glucose levels better than SC injection.   "
207163|NCT00553501|"     RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or carry cancer-killing substances to them. Giving     epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin     lymphoma.      PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab     works in treating patients with previously untreated follicular non-Hodgkin lymphoma.   "
207164|NCT00553514|"     This is a Phase 2, interventional, multi-center, randomized, assessor-blind,     active-comparator, dose-finding study to evaluate a new investigational long-acting follicle     stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI).     This study will compare 4 doses of the investigational drug versus a currently marketed drug     follitropin alfa (Gonal-f ®) prefilled pen with regards to ovulation rate.   "
207165|NCT00553527|"     The purpose of this prospective clinical data collection is to document the performance and     clinical outcomes of Biomet Humeral Stems.   "
207166|NCT00553540|"     The purpose of this study is to determine whether orthopedic spinal supports are effective in     the treatment of low back pain.   "
207167|NCT00553553|"     The patient population requiring hepatic resection can demonstrate an unpredictable risk of     exhibiting peri-operative coagulopathy resulting either from the pre-operative hepatic     pathophysiology or volume of parenchymal resection. Choice of analgesia can be severely     limited.      Currently, the most commonly described use of combined remifentanil infusion and intrathecal     morphine has been in fast-track cardiac surgery. To date, there are no published data     describing its use in the context of major hepatobiliary where the investigators predict it     may provide adequate analgesia with a lower rate of adverse effects over the first 24 hours     after surgery.   "
207168|NCT00553566|"     RATIONALE: Learning about the long-term effects of dietary, lifestyle, and environmental     factors on the risk of cancer progression and recurrence may help the study of bladder cancer     in the future.      PURPOSE: This clinical trial is studying how dietary, lifestyle, and environmental factors     affect patients with early-stage bladder cancer.   "
207169|NCT00553579|"     The benefits of artificial tears to relieve dry eye symptoms include, but are not limited to:     stabilizing the tear film layer, fluid supplement action, improving visual acuity, and     comfort. Studies have found a relationship between some of these benefits. For example,     stabilization of the tear film is important not only to increase the tear break up time     (TBUT), but is key in improving and maintaining visual acuity. These studies have alluded to     the fact that there may or may not be a relationship between residence time and visual     performance. Viscosity is one reason behind the uncertainty. Some solutions contain polymers     which influence the ocular surface when contacted. This can impact residence time and     ultimately visual performance. No prior research has explored the direct relationship between     residence time and visual performance.      Residence time refers to the duration at which the artificial tear resides on the eye.     Methods have been developed to assess residence time by admixing fluorescent tracers to the     solution and then measuring the amount of fluorescence over time. The caveat to methods using     certain tracers has lead to uncertainty in elimination measurements due to corneal     penetration or differing molecular weights (MW) from the active vehicle ingredient in the     solution. For example, low-MW tracers can be eliminated at a different rate than higher-MW     polymers. In addition, the low-MW tracers may be able to penetrate the corneal epithelium     giving a false pre-corneal residence time. Meadows, Paugh, Joshi, and Mordaunt addressed this     issue by developing a technique using a polymer which did not penetrate the cornea and had     the same MW as the active ingredient in the solution FITC-dextran. Based on the assumption     that similar weights are eliminated at the same rate, this technique has shown to be more     economic, manageable, and amendable than previous procedures measuring residence time.      Any ophthalmic drop has the potential to impact visual acuity upon instillation due to the     effect it has on the tear layer components. Studies have observed that taking artificial     tears continuously over time tends to stabilize the tear layer thus minimizing the immediate     drop in contrast sensitivity upon instillation. Measuring the visual effect of artificial     tears, using contrast sensitivity as a measure, provides valuable information about the     therapeutic effect of artificial tears that are meant to stabilize the tear film, thus     improving visual acuity in dry eye patients.      But what about the patient? There is a difference between residence time and retention of     effect- which is often what matters the most for patients. Retention of effect refers to the     beneficial effect of the drop. Currently there is no real measure of retention of effect.     Doctors can assess the tear film objectively, but there have been no strong correlations     between subjective dry symptoms and tear film stability. A possible reason for the lack of     correlation may be due to the fact that subjectivity is difficult to quantify. However,     scales like the Visual Analog Scale (VAS) and Numerical Rating Scale (NRS) have been     established in an attempt to quantify subjective experiences such as visual quality. We will     be using the NRS to gauge the comfort of the drop upon the initial application to get a     general idea of the comfort the drop provides to the user.      Although there have been several studies done on residence time and visual effect of     ophthalmic formulations separately, there is no current research correlating these two     aspects of therapeutic efficacy. This study will be the first to concurrently investigate     residence time (using FITC-dextran) and visual effect of an ophthalmic formulation.   "
207172|NCT00561977|"     We hypothesize that adding beneficial high fiber foods to the diet will result in better     overall dietary quality (measured by the Alternate Healthy Eating Index), which has been     shown to be associated with cancer, than either reducing saturated fat, or a combination of     high fiber and low saturated fat.   "
207174|NCT00562003|"     The primary purpose of this study is to determine the maximally tolerated dose and spectrum     of toxicities encountered with intraperitoneal delivery of a RGD modified conditionally     replicative adenovirus (Ad5-Delta 24RGD) in patients with recurrent ovarian cancer.      Secondary objectives :        -  To determine the biologic effects encountered with intraperitoneal delivery of Ad5-Delta          24RGD in patients with recurrent ovarian cancer cells        -  To determine immunologic response generated against Ad5-Delta 24RGD when administered          intraperitoneally to patients with recurrent ovarian adenocarcinoma        -  To determine potential clinical activity of Ad5-Delta 24RGD when administered          intraperitoneally to patients with recurrent ovarian adenocarcinoma   "
207175|NCT00562016|"     The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the     composite rate of major adverse events during and after the PCI procedure.   "
207176|NCT00562029|"     Premise: Complete resolution of Type 2 Diabetes Mellitus with normalization of blood glucose     and HbA1c in the abscence of medication support is possible with a surgical procedure named     the Duodenal-Jejunal Bypass (DJB) a modification of an established duodenal switch     procedure and is performed utilizing the laparoscopic approach.   "
207177|NCT00562042|"     Hypothesis: Increases in CRP, trop T, and BNP values will correlate significantly with right     heart failure on echocardiogram and with mortality, ICU stay, hospital stay, and escalations     in care.        1. Evaluate whether CRP, trop T, and BNP correlate significantly with right heart failure          on echocardiogram.        2. Evaluate whether CRP, trop T, BNP, and echocardiogram correlate significantly with          clinical outcomes: mortality, ICU stay, hospital stay, and escalations in care.        3. Compare each test's correlation with clinical outcomes to the others, to determine which          test provides the best risk ratio.        4. Compare each trop T value's correlation with echo findings and clinical outcomes to          determine the optimal time to draw trop T levels on a patient presenting with acute PE.        5. These tests will not be used in an attempt to establish a diagnosis of PE.   "
207178|NCT00562055|"     This study will compare the safety and efficacy of [S,S]-reboxetine to atomoxetine in the     treatment of adult patients with attention deficity-hyperactivity disorder.   "
207179|NCT00562068|"     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from growing. Giving alemtuzumab together with combination chemotherapy may kill more     cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of alemtuzumab when     given together with combination chemotherapy and to see how well it works in treating     patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.   "
207180|NCT00562081|"     Patients with asthma can be effectively treated using an Internet-based management system as     demonstrated by:        1. Physician utilization (emergency department visits and unscheduled physician visits).        2. Health-related quality of life scores.        3. Global health care costs.        4. Frequency of severe exacerbations and time to first exacerbation.        5. Asthma control days.        6. Patient education.      Effective patient education will be associated with decreased markers of inflammation and     improved indices of airways function.   "
207181|NCT00562094|"     The aim of the study was to evaluate the effect of Pantoprazole 20 mg/40 mg for 14 days on     symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive     gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep     disorders.   "
207182|NCT00562107|"     The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony     2550 or REPLY DR in a wide range of pacemaker patients.      The expected benefits will be a result of the reduction of the percentage of ventricular     pacing.      It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence     of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits     are a result of spontaneous ventricular activation which ensures a more physiological     ventricular activation.      The benefits will be assessed by comparing the incidence of atrial arrhythmias and the     evolution of the haemodynamic status of the patients (QOL, echo and BNP)   "
207183|NCT00562120|"     An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A     nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic     rhinometry will be used to measure the congestion.   "
207184|NCT00562133|"     The primary objective of the study is to evaluate the postprandial time course of     nitrotyrosine after injection of insulin glulisine compared with regular human insulin.      The secondary objectives are to evaluate the postprandial time course of the following     efficacy parameters after injection of insulin glulisine compared with regular insulin on        -  Blood Glucose        -  Insulin        -  Intact proinsulin        -  Asymmetric dimethylarginine (ADMA)        -  Metal matrix proteasis (MMP-9)        -  Oxidative status (per ox)        -  Interleukin 18 (IL-18)        -  Free fatty acids (FFA)        -  Oxidised LDL (ox-LDL)        -  Microvascular blood circulation measured with laser Doppler at 37 °C (LDF37)        -  Microvascular blood circulation measured with laser Doppler at 44 °C (LDF44)   "
207185|NCT00562146|"     The success rate of unguided nasojejunal feeding tube insertion will be determined in acute     brain injured patients. Factors influencing tube self-progression will be evaluated.   "
207186|NCT00562159|"     This purpose of this study is to determine the efficacy and safety of a grass sublingual     (under-the-tongue) tablet.   "
207187|NCT00562172|"     Primary objective:      To compare long-term glycemic control and preservation of beta cell function when basal     insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients      Secondary objective:      To assess the change of insulin resistance, microvascular complication incidence, patient     satisfaction with treatment   "
207188|NCT00562185|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving doxorubicin together with carboplatin may kill more tumor cells.      PURPOSE: This phase I and phase II trial is studying the side effects and best dose of     carboplatin when given together with doxorubicin to see how well it works in treating     patients with recurrent ovarian cancer.   "
207189|NCT00562198|"     This is an open, randomised, active-controlled, 2-period crossover study comparing the effect     of single doses of Stalevo 200 and Sinemet on striatal (putamenal and caudate) 11C-raclopride     BP in PD patients with wearing-off symptoms. The study consists of 4 visits: a screening     visit (visit 1), 2 treatment periods (period 1=visit 2, period 2=visit 3) separated by a     minimum wash-out period of at least 3 days, and an end-of-study visit (visit 4). Subjects     will be randomly allocated to start the period 1 with a single dose of Stalevo 200 or     Sinemet. After the wash-out the study drug on period 2 will be administered according to a     crossover design.   "
207190|NCT00562211|"     A new topical anesthetic which contains 5% lidocaine and a disinfection ingredient has been     developed and is tested in this study (LidoDyn).      The study examines the efficacy of LidoDyn by comparing it with an already proven anesthetic     agent (EMLA crème).   "
207191|NCT00562224|"     To determine the highest dose of study drug that can be taken without causing serious side     effects in patients with advanced cancer. The study will look at safety of the study drug and     whether the treatment schedule is tolerated by patients.   "
207192|NCT00562237|"     Several combinations of H5N1 antigen concentrations and aluminium-hydroxide adjuvant     concentrations will be tested for their safety and capacity to induce a specific immune     response.   "
207193|NCT00562250|"     The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the     effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and     tolerability of dapagliflozin with be assessed alone and while taking glimepiride   "
207194|NCT00562263|"     The current study aims to investigate the impact of a comprehensive, team-based,     family-centered, lifestyle modification program on body weight, metabolic abnormalities,     fitness measures, and self-esteem in overweight adolescents beginning the study at ages 11-18     years. The intensive program will uniquely include a team structure and a component     designed to address the role of parental modeling in effective lifestyle changes. By     comparing the demographic, psychosocial, and metabolic characteristics of adolescents     according to the degree of weight loss, the study will also more fully characterize the     barriers that prevent successful participation in an intensive lifestyle modification     program.   "
207195|NCT00562276|"     The purpose of this multi-center clinical trial is to evaluate the safety and effectiveness     of inserting an intrauterine device (IUD) immediately after a suction aspiration procedure     compared to inserting the IUD 2-6 weeks after the procedure. This study will also evaluate     how satisfied women are with the timing of their IUD placement. Subjects will be able to     choose between the Paraguard IUD or the Mirena IUD.      The researchers hypothesize that:        1. the expulsion rates measured at 1, 3 and 6 months will be clinically equivalent with          immediate insertion compared with delayed insertion,        2. satisfaction and tolerance of side effects will be higher with immediate IUD insertion          compared with delayed insertion, and        3. overall IUD use/continuation rates measured at 1, 3 and 6 months will be higher with          immediate IUD insertion compared with delayed insertion.   "
207196|NCT00562289|"     A patent foramen ovale (PFO) is found more frequently in patients with an ischemic stroke     than in control subjects.      Therapeutic options to prevent stroke recurrence include antiplatelet drugs, oral     anticoagulants, and transcatheter closure of the foramen. However, there are no published     studies showing convincingly the superiority of any one of these strategies in preventing     stroke recurrence.      The aim of this randomized clinical trial is to assess whether chronic anticoagulation on the     one hand and transcatheter on the other hand are superior to chronic antiplatelet therapy in     preventing stroke recurrence.   "
207197|NCT00562302|"     BS-1053 A Prospective Randomized Multi-Centered Safety and Efficacy Evaluation of the     Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures   "
207198|NCT00562848|"     Motilin is a peptide whose action is controlled by motilin receptors located in the gut.     Action of Motilin at motilin receptors increases the gastric emptying rate (rate of emptying     of food and fluid from the stomach). Compounds which stimulate motilin receptors therefore     provide a potential approach to the treatment of a range of clinical conditions where delayed     gastric emptying may contribute to symptoms, such as enteral feeding intolerance     (post-operative or intensive care patients), gastroparesis, diabetic gastroparesis, and     functional dyspepsia.      This study is the First Time In Human study for the motilin receptor agonist, GSK962040.   "
207199|NCT00562861|"     Bipolar depression is one of the least studied depressive illnesses. The standard practice     for many doctors is to use antidepressant medicines, but there are few studies on the     long-term results of these medicines. The goal of this study is to look at how effective and     safe these medicines are in treating bipolar depression when taken with a mood stabilizer     medicine.      The drug being studied is citalopram, also known as Celexa. Celexa is FDA approved for the     treatment of major depression, but is not FDA approved for the treatment of bipolar     depression. It is, however, standard practice for many doctors is to use antidepressants,     like Celexa, to treat their patients with bipolar disorder depression.      The drug will be studied in three ways. We will see if it helps treat depressive symptoms. We     will see how the drug affects the brain using PET and fMRI scans. Finally, we will look at     the possibility that there may be a gene that could predict if a person would get better     taking the drug using genetics.   "
207211|NCT00563017|"     The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on     long-acting Risperidone microshpheres injection. The major advantage of long-acting injection     over oral medication is facilitation of compliance in medication taking. Non-compliance is     very common among schizophrenic and is a frequent cause of relapse.   "
207212|NCT00563030|"     Coronary artery bypass graft (CABG) surgery is associated with reperfusion syndrome and     activation of inflammatory reaction (SIRS). These are more exaggerated when cardiopulmonary     bypass (CPB) is used.      The aim of the study is to compare signs of SIRS (heart rate, tachypnea or hypocarbia,     leukocytosis, hyperpyrexia or hypothermia) and the granulocytes subsets in peripheral blood     from patients who underwent CABG surgery with or without use of CPB.      The researchers expect significant differences in SIRS criteria between both groups. If the     differences will occur significant, the parameter may be used as candidate variable for a     complications prediction model after CABG surgery.   "
215492|NCT00664495|"     The purpose of the study was to assess the effects of equivalent diet- or exercise-induced     weight loss and related insulin resistance in abdominally obese women.   "
207200|NCT00562874|"     Many of the 28 million people with immunodeficiency virus (HIV) and acquired immunodeficiency     syndrome (AIDS) estimated to be living in sub-Saharan Africa also suffer from malnutrition.     Reproductive age women, their infants and young children are among the most vulnerable for     malnutrition and progression of HIV to AIDS and mortality is increased in the malnourished,     as seen in Eastern and Southern Africa. The HIV Nutrition Project (HNP) research evaluates     the effect of protein and micronutrients in meat on the health and nutritional well being of     Kenyan women living with HIV in rural Kenya and the health and development of their children,     by means of a randomized nutrition intervention. We will determine if meat in the diets of     HIV- infected women and their children (1) protects the immune system and prevents severe     infection, (2) prevents the loss of body mass and enhances the quality of life among drug     naïve women not yet ill enough to warrant antiretroviral drugs and (3) positively impacts     growth and development of vulnerable children of the HIV-infected women when compared to     those given supplements with the same amount of energy but with either soya or wheat protein.     The intervention food with beef protein provides significant vitamin B12, lysine and     bio-available iron, zinc and selenium when compared to the soya and wheat supplements.     Deficiencies of these nutrients may hasten HIV disease progression.      The findings from our project may have implications for the development of initiatives that     are either sustainable or subsidized by the local, regional and/or global economies that     ensure that all HIV-infected individuals have access to adequate nutrition support that     includes foods that provide enough nutrients that are needed to optimize health and     well-being. The knowledge gained may significantly impact other populations at high risk for     decreased immune function such as those with tuberculosis and malaria.      This is a 3 arm randomized design where 225 HIV-infected rural Kenyan mothers with a CD4     between 250 and 500, WHO Stage 1 or 2, and with no co-existing infections, receive with their     child, a nutrition biscuit supplement daily (5 days/week) for 12 months. These women are not     yet ill enough to warrant treatment with antiretroviral drugs in Kenya and therefore a food     intervention may keep them healthy longer and delay the need for drugs.   "
207201|NCT00562887|"     To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who     have moderately to severely active Crohn's Disease.   "
207202|NCT00562900|"     Case matched study on 50 consecutive patients undergoing robotic assisted cholecystectomy (Da     Vinci Robot, Intuitive Surgical). These patients are matched 1:1 to 50 patients with     conventional laparoscopic cholecystectomy, according to age, gender, ASA score, histology and     surgical experience.        -  Trial with surgical intervention   "
207203|NCT00562913|"     Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed     daily combined with Cyclophosphamide and Doxorubicin in cancer patients   "
207204|NCT00562926|"     Gamma-aminobutyric acid (GABA) is the principal inhibitory neurotransmitter in the mammalian     central nervous system. It is involved in a wide spectrum of physiological functions, from     sleep and sedation to convulsions. A defect in neurotransmission involving GABA in     schizophrenia was first propsed in early 1970s, based on neuropathologcial evidence, yet     there is a lack of molecular genetic evidence.      Recently, we carried out a pilot study on a region of the GABA-A receptor β2 subunit gene on     chromosome 5 and found significant association for single nucleotide polymorphisms (SNPs) in     the gene sequence with occurrence of schizophrenia. The current proposal aims to validate     this important finding and to conduct a thorough scanning of the complete gene sequences of     the GABA-A receptor subunit genes in this chromosomal region, including the three major     subunits α1, β2 and γ2. We shall collect samples from Hong Kong Chinese subjects for a     case-control study using haplotype maps and comparing the SNP haplotype frequencies in the     receptor genes, and hence examine whether these genes are in association with schizophrenia,     or other schizophrenia-spectrum disorders, including Alzheimer's disease presenting with     psychotic symptoms.      Based on the observation that patients suffering from the catatonic subtype of schizophrenia     respond particularly well to benzodiazepines, which bind specifically to GABA-A receptors, we     shall also perform data analysis in terms of correlating SNP association with schizophrenia     subtypes. Association of GABA-A receptor genes with schizophrenia would be a major step     forward to determining whether these genes are susceptibility genes for schizophrenia,     thereby paving the way to more effective diagnosis and treatment for this debilitating     disease.   "
207205|NCT00562939|"     The purpose of this study is to determine whether TLR-9 adjuvanted pneumococcal is more     immunogenic than pneumococcal vaccination alone in HIV-infected adults.   "
207206|NCT00562952|"     Increased levels of NT-proBNP are known to increase the risk of cardiac events in diabetic     patients. The other way around, patients with normal values have an excellent prognosis on     short-term. We intend in our study to proof the hypothesis, whether it is possible to     decrease NT-proBNP levels by intensified cardiac prevention care We aim those patients, who     already have elevated levels, although no history of a cardiac disease. This decrease in     NT-proBNP should be translated consequently in a decrease in cardiac events   "
207207|NCT00562965|"     This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given     with rituximab compared to a defined investigator's choice therapy. Subjects will be     randomized to one of these two arms of the study.   "
207208|NCT00562978|"     RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can     find cancer cells and carry tumor-killing substances to them without harming normal cells.     Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to     kill cancer cells or stop them from growing. Giving radiolabeled monoclonal antibodies     together with etoposide and cyclophosphamide before a peripheral blood stem cell transplant     may be an effective treatment for non-Hodgkin lymphoma.      PURPOSE: This phase I/II trial is studying the side effects and best dose of yttrium Y 90     ibritumomab tiuxetan when given together with etoposide and cyclophosphamide followed by an     autologous stem cell transplant and to see how well it works in treating patients with     non-Hodgkin lymphoma.   "
207209|NCT00562991|"     Asthma is a chronic inflammatory condition in which the airways develop increased     responsiveness to various stimuli such as exposure to an allergen, cold air or exercise. It     is characterized by airway hyper-responsiveness, inflammation, increased mucus production,     and airway obstruction. Since inflammation is an important feature of asthma, the use of     non-invasive tests to measure lung inflammation to monitor asthma are of interest.The purpose     of the study is to relate costs associated with healthcare utilization and loss of work and     school time to the primary health outcome of cumulative number of symptom-free days. This     will enable the researchers to determine whether the costs of monitoring exhaled NO to     regular management strategy in recently diagnosed asthma will be offset by reductions in     other costs of asthma-related care, and, if not, whether the additional costs are likely to     be acceptable in terms of the improvement in health outcomes as measured by the additional     number of symptom-free days.   "
207210|NCT00563004|"     DBcare is a herbal food supplement that has been used over the years in India as a     traditionalanti-diabetic formula.DBcare was not tested controlled trials in humans, yet.We     intend to test the ability of DBCare to improve blood sugar level control in patients with     uncontrolled diabetes.   "
207213|NCT00563043|"     Laser photocoagulation has become the treatment of choice in PDR. Laser photocoagulation has     become the treatment of choice in PDR. The aim is to destroy a substantial portion of the     peripheral retina in order to reduce the angiogenic stimulus (decrease the difference between     oxygen demand and the administration). Their effectiveness is determined by the extent of     destruction of the retina (2.4).   "
207214|NCT00563056|"     Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil®     (Formoterol) in adolescent and adult patients.   "
207215|NCT00563069|"     To investigate the efficacy of oral midazolam for patients undergoing rigid cystoscopy in:        1. relieving patient's anxiety and improving satisfaction        2. reducing procedure-related pain        3. facilitating the diagnostic and therapeutic interventions during rigid cystoscopy   "
207216|NCT00563082|"     Systemic lupus erythematosus (SLE) is an autoimmune disease that predominantly affects     younger premenopausal women. The risk of coronary heat disease (CHD) in women with SLE is up     to 50 times higher than in the general population. The conventional risk factors are     insufficient to explain this increased risk of CHD in SLE-affected women. This study will     perform genetic analysis to determine if genetic variation in the F2 gene is associated with     both SLE risk and CHD risk in women with SLE.   "
207217|NCT00563095|"     Primary: To compare the efficacy of TACE and TAIE.      Secondary: To compare the side effects of TACE and TAIE.      The outcome measurements include survival benefit and tumour regression induced by the two     therapies.   "
207218|NCT00563108|"     Graft-versus-host disease (GVHD) contributes substantially to transplant-related morbidity     and mortality. Steroids remains first line therapy for acute GVHD but there is currently no     consensus on second line therapy for those in whom steroids have been ineffective.     Basiliximab has been shown to be a safe and effective immunosuppresant in the prevention and     treatment of rejection after renal transplantation and its role in acute GVHD prophylaxis and     treatment has been described favourably. This is a randomized control trial to investigate     its efficacy and safety in the management of acute GVHD post allogeneic stem cell     transplantation (SCT).   "
207219|NCT00563121|"     To determine the degree of VEGF in Aqueous, vitreous and SRF in patients with ROP in stage V.     Verifying that it is greater to that found in healthy newborn patients with different ocular     pathology.   "
207220|NCT00563134|"     Sepsis sometimes occurs in people who have a serious infection. It is caused by toxic     substances (toxins) from bacteria and other germs entering your bloodstream. Most people with     sepsis will recover with routine medical care before the illness gets more serious. However,     in some people, sepsis does become more serious. This severe sepsis can cause damage to     internal organs (such as your heart, lungs, kidneys, and liver) and can be life threatening.     Special natural fats, (called 'lipoproteins') in our blood are thought to help protect us     from the toxins produced by bacteria during sepsis. Levels of these lipoproteins are often     low in people with sepsis and this may make it more difficult to recover from the disease.     GR270773 is a new drug that has been developed to help the lipoproteins in protecting the     body against toxins. GR270773 is made from purified fats and oils from the soyabean and does     not contain cholesterol. This research study will test the safety (side effects) of GR270773     and whether or not it is effective in preventing complications in people with severe sepsis.   "
207221|NCT00563147|"     The purpose of this study is to test the safety and tolerability of tivozanib (AV-951) and     Torisel™ given in combination for renal cell cancer. The study will also assess the effects     of the combination of tivozanib (AV-951) and Torisel™ on the tumor. Tivozanib (AV-951) is a     VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking     blood flow to the tumor. Temsirolimus is an mTOR inhibitor which is approved for the     treatment of advanced renal cell carcinoma.   "
207222|NCT00563160|"     To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for     operable stages of non-small-cell lung cancer and to identify novel molecular markers     correlated with chemosensitivity and prognosis   "
207223|NCT00563173|"     The purpose of this study is to evaluate if the DNA vaccine CHRONVAC-C® intended for future     treatment of Hepatitis C infections is safe and tolerated when administered to HCV infected     individuals with a low viral load. In addition the capability of the vaccine to induce an     immune response and the effect on viral load will be studied. In order to increase the uptake     of the vaccine the intra muscular injection is combined with electroporation, meaning that a     brief electric field is applied to the injection site resulting in temporary pores in the     cell membranes that allows the vaccine to enter the cells.   "
207224|NCT00563186|"     The Physical plant design and the use of engineering controls significantly affects the     acquisition and transmission of pathogenic organisms in a hospital environment.   "
207225|NCT00563199|"     This study is a randomized controlled trial designed to evaluate the effectiveness of a nurse     delivered stage-matched intervention to cardiac patients for cessation of tobacco use. Review     of literature shows that there is a clear lack of empirical evidence on (1) using nurses to     deliver stage-matched smoking cessation interventions, and (2) the effectiveness of such     intervention for cardiac patients in Chinese populations. The ultimate goal of the     intervention achieve a higher quit rate in the intervention group than in the controls. In     addition, the change in the patient's smoking behaviour such as reduction of the number of     cigarettes smoked, and progression to a higher stage of readiness to quit, will also be     measured. This study is the first step to address the urgently needed data for (1) promoting     the delivery of nurse-run stage-matched smoking cessation interventions to help patients stop     smoking, (2) developing smoking cessation policy and programmes in the hospitals and for the     health care system, and (3) contributing an evidence-based approach to orientate clinical     services towards prevention, so as to reduce premature deaths and the enormous disease burden     of our society.   "
207226|NCT00563212|"     Idiopathic pulmonary fibrosis (IPF) is a progressive disease for which there is no effective     treatment. Interferon-gamma is a medication that has been used for other lung diseases to     decrease scarring and fibrosis. Studies of interferon-gamma injected under the skin did not     show any improvement in survival in patients with IPF. We hypothesize that giving     interferon-gamma as a nebulized mist directly into the lungs can affect the immune system in     a way that decreases fibrosis.   "
207227|NCT00563225|"     A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and     safety of insulin glargine on subjects with Type 2 Diabetes Mellitus   "
207228|NCT00563238|"     Silent myocardial ischemia is known to occur in the general medical intensive care unit     population immediately following tracheal extubation. We believe these patients are at risk     for primary cardiac events in the 4 hours immediately following extubation. Metoprolol is a     selective beta-1 antagonist, with little to no beta-2 activity at low and moderate doses. The     cardioprotective effects of beta blockade have been well documented in randomized controlled     trials. In patients undergoing extubation, prophylactic use of intravenous metoprolol may     reduce post-extubation ischemia events as well as precursors of cardiogenic pulmonary edema     (atrial and ventricular wall tension). Our primary hypothesis is that prophylactic metoprolol     (titrated to reduce resting heart rate by at least 10%) prior to tracheal extubation will     reduce the rate of ischemia as judged by ST segment analysis.   "
207229|NCT00563251|"     Bronchiolitis obliterans syndrome (BOS), an obstructive airway disease as a result of chronic     rejection, is one of the major causes of morbidity and mortality in long-term survivors of     allogeneic bone marrow transplantation (BMT). Although augmentation of immunosuppressive     treatment might help but the only effective treatment for BOS is by lung transplantation.      Macrolide antibiotics, which have been licensed to use as antibacterial agents for decades,     have been found to have immunomodulatory properties in addition to their antibacterial     activity. Low dose Azithromycin, an antibiotic of the macrolide family, has been shown to     have promising result in a pilot study in treating BOS associated with lung transplantation.     We propose to perform a prospective, randomised, double blind study to test the efficacy of     Azithromycin in treating BOS after BMT. Patients with proven BOS after BMT will be randomised     into two groups based on lung function parameters. One group will receive low dose     Azithromycin while placebo will be provided for the other group. Lung function will be     serially monitored at 3 month, 6 months and 12 months after commencement of treatment with     drug/placebo. If Azithromycin was proven effective in treating BOS then all patient with     proven BOS should be treated with this drug.   "
207230|NCT00563264|"     The purpose of this study is to evaluate the efficacy of an intervention (KAN-DO: Kids &     Adults Now - Defeat Obesity) encouraging postpartum mothers and their preschool-aged children     to work together to promote healthy eating, increase physical activity, and reduce sedentary     behaviors. Via instruction in parenting skills and behavior change strategies, the goal is     relative weight maintenance in children of healthy weight, and relative weight reduction in     overweight children. The intervention will focus on a child (2-5 years of age) and his or her     overweight or obese mother, who has just delivered a second or subsequent baby.   "
207231|NCT00563277|"     Pterygium is known to induce with-the-rule astigmatism. The corneal curvature along the long     axis of the pterygium body is flattened. The excision of pterygium will result in steepening     of the cornea and reduction of astigmatism. Therefore, the effect of pterygium excision on     intraocular lens (IOL) power calculation has been examined in our previous study. The study     confirmed that pterygium can cause alteration of IOL power.      The determination of IOL power for cataract surgery is usually calculated from IOL formula     called SRK II formula. IOL power = A - (2.5 x AL)-(0.9 x K). Variable A denotes the     A-constant of the intraocular lens which is dependent on the IOL material and refractive     index. Other variables for input include axial length (AL) and keratometry (K). A larger K     reading will result in a lower estimated IOL power and vice versa. Previous studies have     documented simultaneous cataract and pterygium operation resulted in reasonable visual     outcome without adjustment of IOL power.      With the presence of a pterygium, the cornea is flattened and lead to a reduction of K value     and over-estimation of calculated IOL power. This randomized controlled trial is designed to     compare the refractive outcomes of sequential and simultaneous pterygium and cataract     operation.      Pterygium excision should be done with various adjuvant therapies to minimize recurrence. Our     previous studies reliably demonstrated limbal conjunctival graft and mitomycin C were     effective methods to achieve low pterygium recurrence. We use limbal conjunctival autograft     as the adjuvant therapy in the current study because this method is safer to be performed     either alone or in combination with phacoemulsification. We avoid using mitomycin C as the     adjuvant therapy in order to minimize the possibility of intraocular toxicity due to seepage.   "
207232|NCT00563290|"     This phase II trial is studying how well dasatinib works in treating patients with     unresectable or metastatic squamous cell skin cancer or RAI Stage 0-I chronic lymphocytic     leukemia. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth.   "
207233|NCT00563303|"     Interest of treatment of polytraumatisms with corticoids (hydrocortisone) for patient with     relative adrenocortical insufficiency on frequency of nosocomial infection, and hemodynamic     complications and organs injuries.   "
207234|NCT00563316|"     The primary objective of this study is to determine if panitumumab affects the     pharmacokinetic (PK) profile of irinotecan.   "
207235|NCT00563329|"     The aims of this study are (1) to examine the effect of smoking reduction intervention     (reduction counseling and nicotine replacement therapy, NRT) (a) on smoking cessation and (b)     on reducing daily cigarette consumption among smokers not willing to quit smoking but want to     reduce smoking, and (2) to examine the effect of adherence intervention in producing a higher     (a) adherence rate, (b) reduction rate, and (c) quit rate.   "
207236|NCT00563342|"     The primary objective of the study is to examine the risk of catheter dysfunction during the     dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled     silicone catheters of end stage renal failure patients treated by hemodialysis.      The catheters dysfunction rate is the primary outcome. The dysfunction is defined as partial     or complete occlusion or infection associated with dialysis catheter.      As a secondary outcome, the dialysis quality is also examined (urea reduction rate, total     ultrafiltration)   "
207237|NCT00563355|"     The primary aim of the study is to evaluate the effects of correction of anemia using     erythropoietin on the progression of atherosclerosis and cardiac muscle thickening in     patients with chronic kidney disease   "
207238|NCT00563368|"     The objective of this study is to evaluate the safety and efficacy of various doses of     VI-0521 compared to both placebo, and the single-agent components that comprise each     combination dose. This study will provide confirmatory data to demonstrate that doses of     VI-0521 have efficacy that is greater than placebo and each of the single-agent components     that comprise the combination dose.   "
246576|NCT01079130|"     This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo     and salmeterol   "
207239|NCT00563381|"     This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group     trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg)     via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week     randomised treatment phase. Patients who withdraw prematurely from trial medication will be     encouraged to remain in the trial and participate in follow-up telephone contacts until their     predicted normal exit date from the trial (i.e. 52 weeks after taking the first dose of     randomised treatment). The phone calls will be made at all scheduled visits.      The primary objective of this study is to compare the effect of tiotropium (18 mcg)     inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD     exacerbations.      The primary endpoint is time to first COPD exacerbation during the 52 week randomised     treatment period. A COPD exacerbation will be defined as a complex of respiratory events /     symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing,     dyspnoea or chest tightness with at least one symptom lasting at least three days requiring     treatment with antibiotics and/or systemic steroids and/or hospitalisation.      The onset of an exacerbation is defined as the onset of the first new or increased reported     symptom. The end of the exacerbation should be recorded as defined by the investigator.      Only COPD exacerbations with onset during randomised treatment will be included in the     analysis.   "
207240|NCT00563394|"     224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78)     or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone     antibiotic.   "
207241|NCT00563407|"     Radiotherapy is standard treatment for breast cancer after lumpectomy. Although this     treatment showed substantial patient benefits and decrease of local recurrence and deaths     from breast cancer, it also results in some severe late side-effects, such as skin fibrosis     and cardiac failure. It's possible to offer breast irradiation (RT) and minimizing toxicities     radiation dose to skin, lung and heart. This will be achieved with highly conformal RT     delivery using Tomotherapy. We plan to evaluate this approach in clinical study. We plan also     to evaluate the value of genomic, cellular and functional imaging endpoints as predictive     markers of toxicity in our breast cancer population. This program is expected to     prospectively validate that Tomotherapy for breast RT can decrease skin, lung and heart     toxicities and maintaining excellent cancer control after lumpectomy.   "
207242|NCT00563420|"     Lung cancer is the commonest malignant disease with a 5-year survival of 14%. In Hong Kong,     it accounts for about 30% of all cancer death. The poor prognosis of lung cancer is due     largely to the late clinical presentation of the disease. In order to improve the prognosis     of lung cancer, an obvious approach is to develop sensitive methods for detecting lung cancer     at much earlier stages when treatment is more likely to be curative.      However, the best way for identifying early lung cancer is still need to be determined. We     hypothesis that by examining specimens that contain shed bronchial epithelial cells i.e.     sputum, lung cancer can be sampled in its earliest possible phase. And by using     autofluorescence bronchoscopy, a system specifically designed to detect early lung     cancer/pre-invasive lesions, to identify the source of abnormal cells, we may able to detect     eraly lung cancer and followed by curative treatment to improve the prognosis of this     disease.   "
207243|NCT00563433|"     224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78)     or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone     antibiotic.   "
207244|NCT00563446|"     Anaemia is a common consequence of chronic renal failure. Darbepoetin alfa is a unique     erythropoietic protein that stimulates erythropoiesis by the same mechanism as endogenous     erythropietin and conventional recombinant human erythropoietin (rHuEPO). Darbepoetin alfa     has been shown to have a serum half-life 3-fold longer than that of rHuEPO, which allows     dosing at extended intervals and less frequent injection.      The objective is to evaluate the efficacy and safety of darbepoetin alfa therapy given at an     extended once monthly dosing interval in the treatment of renal anaemia in continuous     ambulatory peritoneal dialysis.   "
207245|NCT00563459|"     The purpose of this research study is to compare the long term effectiveness, safety and     tolerability of carisbamate compared to two other frequently prescribed anti-epileptic drugs     (AEDs) in patients with epilepsy.   "
207246|NCT00563472|"     This is an open study in 50 young, healthy, female volunteers. Women who want to participate     and who are using hormonal contraception stop using their hormonal contraceptive and wait for     their first spontaneous menstruation (i.e. after a wash-out cycle). Women who do not use     hormonal contraception wait for their next menstruation. From the 9th day after start of the     menstruation onwards follicle growth will be monitored by ultrasonography until ovulation     occurs or until day 24 after start of their menses. Women who ovulate within 24 days after     start of their menses will be eligible to participate and will be stratified in one of 4     groups: 10 mg estetrol (E4) alone, 20 mg E4 alone, 20 mg E4 combined with 150 mcg desogestrel     and 20 mg E4 combined with 200 mg progesterone. The subjects will be treated for 28 days.     Treatment will start on the first day of their menses after the pre-treatment cycle.      During the study period (28 days) the activity of the hypothalamic-pituitary-ovarian (HPO)     axis will be investigated by measuring follicular development using ultrasonography and by     determining serum concentrations of Follicle Stimulating Hormone (FSH), Luteinising Hormone     (LH), estradiol (E2) and Progesterone (P).   "
207247|NCT00563485|"     The purpose of the study is to compare two alpha blockers, terazosin and doxazosin GITS, in     achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in     delaying or avoiding a TURP.   "
207248|NCT00563498|"     The primary purpose of this project is to investigate if addition of glutamine, an amino     acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow     transplantation reducing the occurrence of veno-occlusive disease and severity of mucositis.   "
207249|NCT00563511|"     The purpose of this proposed RCT is to test (a) the effectiveness of smoking cessation     intervention (counseling and NRT) among patients with ED; and (b) the effectiveness of     adherence intervention (ADIN) to increase adherence to NRT use in order to increase quit     rate.   "
207250|NCT00563524|"     The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094     administered to subjects with psoriasis   "
207323|NCT00564499|"     A Scientific Research Program to evaluate the efficacy of SYMBICORT® 320/9μg in the treatment     of COPD in real life environment by General Practitioners   "
207251|NCT00563537|"     PET imaging of activated microglia offers a tool of investigation of a range of brain     diseases where neuroinflammation is a component.      Amyotrophic lateral sclerosis is the most frequent motoneuronal disease in adult.      This study was designed to explore the feasibility of molecular imaging modality by Positron     Emission Tomography using 18F-X as an in vivo marker of activated microglia for the     assessment of neuroinflammation in amyotrophic lateral sclerosis.      PET may help in the diagnosis of the disease and, further, may allow assessment of the     efficacy of antiinflammatory treatment.   "
207252|NCT00563563|"     The purpose of this study is to determine whether a combination of naltrexone SR and     bupropion SR is safe and effective in the treatment of nicotine-dependence in overweight and     obese subjects.   "
207253|NCT00563576|"     Many women choose Depo-Provera for birth control because it is easy to use and very     effective. However, a significant number of Depo-Provera users experience irregular bleeding     during the first 90 days. Many users discontinue after their first injection due to irregular     bleeding. This study will evaluate the effect of using an estrogen vaginal ring during the     first 90 days of Depo-Provera use to see if it is acceptable to women and whether it     decreases irregular bleeding during the first 90 days of use and increases continuation to a     second injection.   "
207254|NCT00563589|"     There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early     mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a     matched unrelated donor or HLA-mismatch sibling. Mycophenolate mofetil (MMF) has been shown     to be an effective and safe immunosuppressant in the prevention and treatment of rejection     after solid organ transplantation. Its role in acute GVHD prophylaxis in high risk SCT will     be investigated in this clinical trial.   "
207255|NCT00563602|"     This is a prospective trial of random distribution, open, parallel group, in which patients     with esophagic variceal bleeding will be randomized into two treatment groups, after     controlling acute bleeding. All patients received standard medical therapy with b-blockers     and endoscopic ligation (LEV) of esophageal varices.      The control group will be assigned to receive LEV + Nadolol + MNI. The experimental group     will be assigned to receive treatment according to the hemodynamic response.      All patients included in the experimental group received LEV and pharmacological treatment     nadolol alone or combined with MNI or Prazosin (PZ)   "
207256|NCT00563615|"     Functional constipation is a common problem in Hong Kong. In a recent telephone survey, the     prevalence of constipation as defined by Rome II criteria was 14%. Apart from organic,     metabolic, neurological and drug induced causes, constipation most often arises from 2     disorders of colorectal motility: slow transit constipation or pelvic floor dysfunction or     both. In the position statement from the American Gastroenterological Association , colon     transit study was recommended to differentiate slow transit constipation from pelvic floor     dysfunction. The management algorithm for normal transit and slow transit constipation was     different and surgery should be considered for patients with slow transit constipation. In a     recent paper by Bonapace , scintigraphy could be used to study both gastric, small bowel and     large bowel transit time. The clinical diagnosis was changed in 51% of cases of constipation     after scintigraphy and patient management such as adding a prokinetic agent, referral to     biofeedback center, decision on surgery was affected in 64% of cases.      Tegaserod is a recently approved prokinetic agent to be marketed in Hong Kong for the     management of patients with constipation predominant irritable bowel syndrome (C-IBS). In a     paper from Mayo clinic based on scintigraphic examination, tegaserod 2mg bd accelerates     orocaecal transit in C-IBS patients. However studies in functional constipation basing on     tegaserod 6 mg twice daily has not been published yet. Therefore, the Gastroenterology team     and nuclear medicine teams of Princess Margaret Hospital, Gastroenterology teams of Caritas     Medical Center and Yan Chai Hospital decide to study small and large bowel transit in     functional constipation patients by scintigraphy. The efficacy of tegaserod in improving     bowel transit is also examined in this randomized double blind placebo controlled study.   "
207257|NCT00563628|"     Laser photocoagulation has become the treatment of choice in PDR. Laser photocoagulation has     become the treatment of choice in TMD. The aim is to destroy a substantial portion of the     peripheral retina in order to reduce the angiogenic stimulus (decrease the difference between     oxygen demand and the administration). Their effectiveness is determined by the extent of     destruction of the retina (2.4).   "
207258|NCT00563641|"     The present study will test the use of very early nasal continuous airway pressure(NCPAP)with     and without surfactant in premature infants with clinical evidence or respiratory distress     syndrome. We hypothesize that premature infants exposed to very early NCPAP and surfactant     will require less mechanical ventilation compared to those premature infants exposed to NCPAP     alone.   "
207259|NCT00563654|"     The purpose of the study is to compare alfuzosin GITS once daily versus placebo in achieving     a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or     avoiding a TURP.   "
207260|NCT00563667|"     Pterygium is known to induce with-the-rule astigmatism. Excision of pterygium will steepen     the cornea and reduce corneal astigmatism. We postulate that the alteration of keratometry     reading will indirectly affect the IOL power calculation in cases with concurrent pterygium     and cataract. Concurrent pterygium and cataract is common in Hong Kong and other tropical     regions. The effect of pterygium excision on intraocular lens power calculation is     investigated.   "
207261|NCT00563680|"     Single-arm, open-label study of AMG 479 in up to 35 subjects with Ewing's Family Tumors     (EFTs) and Desmoplastic Small Round Cell Tumors (DSRCTs) who have progressed or recurred     after at least one prior chemotherapy regimen. An exploratory cohort of an additional up to     10 subjects with prior exposure to anti-IGF-1R therapy and who have progressed or recurred     after at least one prior chemotherapy regimen will also be assessed.   "
207262|NCT00563693|"     An investigation where patients with chronic heart failure and cheyne stokes respiration,     treated with adapitve servo ventilator, will improve their cardiac function and quality of     life.   "
207263|NCT00563706|"     The primary purpose of this protocol is to establish the efficacy, safety, and tolerability     of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of     schizophrenia.   "
207264|NCT00563732|"     Primary: To evaluate the effects of multiple doses of lecozotan SR on the PK profile of a     single dose of digoxin in healthy adult subjects.      Secondary: To assess the safety and tolerability of the coadministration of lecozotan SR and     digoxin.   "
207265|NCT00563745|"     In unstable patients needing oxygen and/or home mechanical ventilation, a nurse-centred TM     programme (supported by continuous availability of a call centre and a pulsed oxygen system)     is cost/effective saving health care resources.   "
207494|NCT00558298|"     The purpose of this study is to document the long-term safety of 25, 50 or 75 mg long-acting     injectable risperidone given via injection to the gluteal muscle every 2 weeks to patients     with schizophrenia or schizoaffective disorder.   "
207266|NCT00563758|"     Idiopathic or functional constipation is a common disorder, affecting up to 20% of the     population depending on demographic factors, the sampling situation and the definitions used.     Constipation is a symptom of many diseases and is a collective term, used by the patient to     imply that stools are too hard, too infrequent or too difficult to pass. A recent survey     conducted in Hong Kong showed a prevalence of 14% according to the Rome criteria. Based on an     epidemiological study in US, there were 2.5 million annual physician visits for this problem.     Exact epidemiological data however are lacking, mainly because of the difference between     self-reported constipation and scientifically defined constipation.      Treatment of constipation is usually based on increased dietary fiber and supplementation     with bulking agents, exercise, and habit training. However, often only partial relief is     obtained, and the majority of patients use non-bulking laxatives on a regular basis without     medical supervision. Chronic use of non-bulking laxatives is often inappropriate3, and may     lead to side effects such as dependency and progressive tolerance, electrolyte imbalance,     and, for the anthraquinones, melanosis coli. In addition, stimulant laxatives may damage the     myenteric plexus4, resulting in cathartic colon5. A more appropriate approach to the therapy     of constipation consists of physiologically stimulating intestinal motility.      Tegaserod, an aminoguanidine indole compound, is a representative of a new class of 5-HT4     agonists, with regard to both chemistry and pharmacology. Activation of 5-HT4 receptors     triggers the release of neurotransmitters from the enteric nerves resulting in increased     contractility and stimulation of the peristaltic reflex.      In animal models, tegaserod acts as a motility-enhancing agent, exerting activity throughout     the gastrointestinal tract11. Tegaserod has also been shown to significantly accelerate bowel     transit in healthy volunteers and in patients with constipation-predominant irritable bowel     syndrome (C-IBS).      Based on the pharmacodynamic properties, tegaserod is a promotile compound suitable for the     treatment associated with small and/or large bowel dysfunction e.g. constipation.      From phase III adequate and well-controlled studies in patients with C-IBS it has been shown     that tegaserod was effective in relieving symptoms of C-IBS. The effect was seen as early as     the first week of treatment with sustained effects over 12 weeks. Both tegaserod 4 mg/d (2 mg     bid) and 12 mg/d (6 mg bid) significantly increased bowel frequency and decreased stool     consistency. It is proposed to test both doses for the phase III program in chronic     constipation.      The aim of this study is to demonstrate the effect of tegaserod on bowel habits in patients     suffering from chronic idiopathic constipation.   "
207267|NCT00563771|"     To provide treatment opportunity to children and adolescent patients with hematologic     malignancies by supplying the delayed marketed product and also to observe the efficacy and     safety of rasburicase used in the treatment of hyperuricemia   "
207268|NCT00563784|"     The goal of this clinical research study is to find out if erlotinib given with chemotherapy     and radiation therapy can help to control Non-Small Cell Lung Cancer (NSCLC). The safety of     this combination treatment will also be studied.      Researchers will also test the tissue from your earlier biopsy to measure the levels of     epidermal growth factor receptor (EGFR). The purpose of EGFR testing is to learn about any     link between various forms of EGFR and your response to treatment with erlotinib.      Primary Objective:      Determine the feasibility of concurrent erlotinib and chemoradiation as measured by safety     and compliance. Safety is measured by the rate of grade 3 or worse nonhematological     toxicities occurring prior to the beginning of consolidation therapy (including all     toxicities attributed to chemoradiation occurring within 90 days of the start of radiation     therapy); compliance is defined as the completion of the treatment regimen with no more than     minor variations.      Secondary Objectives:        1. Investigate associations between EGFR expression and toxicity, response, overall          survival, and progression        2. Estimate overall survival of patients on the study regimen (one and two year rates,          median survival).        3. Estimate the time to disease progression of patients on the study regimen (one and two          year rates)        4. Estimate the treatment response rate of patients on the study regimen (complete and          partial response rates)   "
207269|NCT00563797|"     The objective of this study is to evaluate the efficacy of mecamylamine (MEC, 10 mg/day)     versus placebo in reducing depressive and alcohol symptoms in patients with depression and     co-morbid alcohol dependence. The researchers hypothesize that MEC will significantly reduce     depressive symptoms and decrease alcohol consumption compared to placebo in patients with     depression and alcohol dependence who are on a stable dose of a selective serotonin reuptake     inhibitor (SSRI).   "
207270|NCT00563810|"     This is a multiple dose study assessing the safety, tolerability, pharmacokinetics and     pharmacodynamics of an investigational new drug.   "
207271|NCT00563823|"     RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with     metastatic cutaneous melanoma that cannot be removed by surgery.   "
207272|NCT00563836|"     Primary evaluation of the safety, tolerability and feasibility regarding specific     postoperative complications of an adjuvant treatment with catumaxomab administered after     tumor resection.   "
207273|NCT00563849|"     To determine the efficacy and safety of the combination of leflunomide and methotrexate for     treating active rheumatoid arthritis (RA) in an open noncomparative multicenter trial.   "
207274|NCT00563862|"     To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally     advanced nasopharyngeal carcinoma.   "
207275|NCT00563875|"     Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It     has been speculated that these patients might be resistant to aspirin, and studies have     indicated that this phenomenon is related to a less favourable prognosis. Furthermore,     patients with diabetes mellitus have an increased risk of myocardial infarction and other     vascular events and, recently, it has been suggested that diabetics do not respond adequately     to aspirin. The purpose of this study is to compare the prevalence of aspirin resistance in     diabetics and non-diabetics. Furthermore, patients who suffered a myocardial infarction while     being treated with aspirin are included. We hypothesize that the prevalence of aspirin     resistance will be higher among diabetics compared to other patients and to healthy     individuals.   "
207276|NCT00563888|"     Effective Treatment of PTSD involves talking about the traumatic event in detail.It is     unclear how this process influences the sensory-specific trauma network (fear structure)in     the traumatized person. The goal of the project is to test the hypothesis that     treatment-facilitated recovery does not change the original fear structure but establishes an     inhibitory mechanism that depends on verbal activity. An affective visual steady-state     paradigm in magnetencephalography (MEG) using positive, aversive and neutral picture stimuli     will be used to examine the spatial and temporal pattern of the processing of emotional     stimuli. To examine the effects of treatment this paradigm will be used as outcome measure     within a randomized controlled trial of Narrative Exposure Therapy and a waiting-list control     condition for severely traumatized torture victims.   "
207522|NCT00558701|"     This single-center, prospective, randomized, and controlled study evaluated the efficacy of     silver-coated dressing with active microcurrent in comparison to silver-coated dressing with     sham microcurrent on wound-closure time for autogenous skin donor sites.   "
207277|NCT00563901|"     High blood pressure is one of the most common health problems in the United States. There are     many medications to treat high blood pressure, but there is a large variance in how people     respond to these medications. It is believed that genetic variations may contribute to the     inconsistent treatment response. This study will use genetic analysis to determine whether     particular genes interact with high blood pressure medications to modify the risk of certain     cardiovascular diseases.   "
207278|NCT00563914|"     The primary objective is to assess the safety of different doses of ferroquine with     artesunate (AS) in adult African patients with uncomplicated malaria.      The secondary objectives are to assess activity in reducing parasitemia and the     pharmacokinetics of ferroquine and its metabolites.   "
207279|NCT00563927|"     To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma.   "
207280|NCT00563940|"     Diabetic macular edema is a common complication of ocular diabetes mellitus and can cause     blindness. Hypoxygenation of the retina stimulates tissue mediators, especially different     subtypes of vascular endothelial growth factor (VEGF). VEGF is responsible for proliferation,     extension and increased permeability of the vessels. The aim of our study was to examine the     short-term effect of intravitreal bevacizumab (Avastin® 1.25 mg in 0.05 ml) and triamcinolone     on visual acuity and central retinal thickness in patients with clinically significant     diabetic macular edema (CSME).   "
207281|NCT00563953|"     This is a multicenter study of a primary chemotherapy regimen in breast cancer patients at     risk of developing cardiotoxicity. The aim of the study is to evaluate the response rate at     surgery.   "
207282|NCT00563966|"     It is generally understood that smoking during pregnancy has deleterious effects on the     developing fetus, although research on smoking during pregnancy has been limited in focus,     with most studies focused on birth weight of newborns and children's behavioral disturbances.     However, little is known about the neurobiological underpinnings of nicotine-related     developmental deficits and even less is known about genetic and environmental factors that     may exacerbate the risk for such deficits in some children. In this study, we propose to     examine the relation between antenatal exposure to nicotine and infants' stress-responses     before and after birth (2-days, 6-months) and its moderation of by family-based stressors and     genes related to nicotine metabolism and stress responsivity.      We hypothesize that the risk imposed on infants by antenatal exposure to nicotine is     moderated by genotype that influences functioning of the HPA axis, metabolism of nicotine,     and stress-levels and parenting that influence the development of neural substrates (HPA     axis) and infants' capacity to cope with stress. There is a growing consensus that Gene x     Environmental (G x E) interplay likely mediated by epigenetic effects constitute one of the     central mechanism by which complex disorders develop. Our proposal offers an exceptional     paradigm to explore the association between genes, environment, and G x E interactions on the     neural and behavior response of children to stressful challenges.   "
207283|NCT00563979|"     The primary objective of EMPOLS is an increase in macular pigment density (MPD) and contrast     sensitivity (CS) after six months supplementation of oral non-compound ester Lutein 10 mg     daily, contained in VitaluxPlus®.   "
207284|NCT00563992|"     This study will evaluate the effectiveness of two different mood stabilizing medications,     lithium and valproate, in treating people with bipolar disorder and suicidal behavior.   "
207285|NCT00564005|"     Identify the possible mechanisms and the relative effectiveness of existing rehabilitation     approaches that target upper extremity deficits of stroke patients on the ground that these     approaches are based on neuroplasticity principles and sound motor control theories.   "
207286|NCT00564018|"     To determine whether using a long-acting insulin analog at the time of diagnosis, instead of     intermediate-acting insulin, affects the rate of loss of the body's ability to make insulin     in children with newly diagnosed type 1 diabetes.   "
207287|NCT00564031|"     Endothelial dysfunction in resistance arteries in women after the menopause is important for     the development of high blood pressure and cardiovascular disease   "
207288|NCT00564044|"     Aging, birth trauma and extensive pelvic surgery are the causes known to cause advanced     pelvic organ prolaspe, fecal as well as urinary incontinence. Surgical treatment is the last     resort to manage the above-mentioned clinical manifestations of pelvic floor disorders except     the subject is too frail to receive operation.      In order to improve the outcome of reconstructive pelvic surgery, reinforcement with     synthetic mesh or biological material is the modern trend in pelvic repair. Unfortunately no     prosthesis including synthetic or biological is ideal because vaginal erosion with mesh     extrusion which is the subject of this protocol and other complications were reported     continuously. As per the literature, the rate for mesh vaginal extrusion ranged between 2.4     and 17% when polypropylene which is the most popular synthetic material used for the     mid-urethral sling or pelvic reconstructive surgery to date. The causes of this complication     are still controversial which include rejection, poor quality of tissue, surgical artifact,     material of mesh and etc.      A prospective controlled study for the investigation of the cause for mesh vaginal erosion     was conducted and the results revealed evidences of immune reactivity after mesh     implantation, albeit the evidence was not solid (Am J Obstet Gynecol 2004; 191(6): 1868-1874     ). As per the pilot study initially done by us to determine the biofilm-related-infection, we     have found bacterial biofilm could adhere to surfaces and interfaces, i.e. bacteria located     in the cells just beneath the contacting surfaces in the electron microscopic (EM) analysis.     In addition, soon after bacteria infection, proteins in biofilm undergo conformational     changes, making them immunogenic and triggers a typical inflammatory response leading to     activation of the complement system. Thus, we plan to use CD (clusters of differentiation)     antigens - 4, 8, 20, 25, 40, 68 and quantitative analysis of FoxP3 to determine the function     of regulatory T cells in the immune response. In addition, bacterial culture and EM analysis     of the excised mesh with surrounding vagina tissue will be performed for further analysis of     biofilms.   "
207289|NCT00564057|"     Human immunodeficiency virus infection and highly active antiretroviral therapy (HAART) are     associated with an increased risk of cardiovascular disease: a wide range of alterations in     lipid and glucose metabolism has been increasingly recognized in HIV patients treated with     HAART. Few data are available on the effects of antihypertensive treatment on cardiac     morpho-functional characteristics and metabolic parameters in HIV patients. Aim of the study     is to assess the effects of chronic therapy with angiotensin receptor blocker(candesartan)or     calcium channel blocker (lercanidipine)on metabolic profile and cardiac remodelling in HIV     hypertensive patients.   "
207290|NCT00564070|"     This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating     people with depression and type 2 diabetes.   "
207431|NCT00557453|"     The treatment of acute cholecystitis includes limited oral intake, antibiotics and early or     delayed surgery. To date there are no randomized trials proving the benefit of antibiotic     treatment.      The aim of this study is to prospectively and randomly compare between patients that are     admitted for acute cholecystitis and treated with or without antibiotics.   "
207291|NCT00564083|"     This research protocol is a randomized controlled trial. It is being done to compare and find     out the relative differences between the materials, (Pelivisoft) natural organic mesh to     poly propylene mesh (Pelvitex) manmade mesh after a surgery known as sacral colpopexy. This     surgery involves supporting the prolapsed vaginal wall with a piece of material (known as a     graft) attached to a ligament along your backbone (or sacrum). These materials are both FDA     approved and widely used. The following objectives: anatomic outcomes, graft-related     complications between the two materials, changes in pelvic organ prolapse-related quality of     life, subjective changes in sexual function,changes in bowel function and the prolapse     related pain present after sacral colpopexy will be evaluated.      The study visits are all under standard of care. Study questionnaires are unique to the study     and will be completed at the enrollment in hospital, 2, 6,12 weeks, 6 months and one year     visits The questionnaires are related to bowel function, bladder function, prolapse and     sexual activity.      Permission will be requested to contact the patient again 5 years after surgery. Contact in     the future will in no way obligate the patient to participate.      There may or may not be direct medical benefits to the participant. Decreased risk of erosion     may be a possible benefit if placed in the organic natural arm of the study. The     information learned from this study may benefit other patients in the future   "
207292|NCT00564096|"     Until recently stimulation of nervous tissue deeper than approximately 2 cm from the scalp     (will hence be called non-deep TMS) was not possible (3).A new coil (H-coil invented in     Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel ) capable of     stimulating more than twice this depth (Up to 5 cm)was recently developed.Deep TMS is using     this h-coil.      Auditory hallucinations are reported by 50% to 70% of patients with schizophrenia and     generally consist of spoken speech or voices. . Patients usually describe the hallucinatory     experience as distressing, consistent with evidence that the most common hallucinated     utterances are abusive terms,contributing in up to 25% of the cases to a serious suicide     attempt.The neuroanatomical basis of auditory hallucinations is thought to involve increasing     blood flow of the speech perception areas of the brain, such as the superior temporal cortex     of the dominant hemisphere as well as right and left superior temporal cortex.Brain imaging     studies of patients with auditory hallucinations have revealed an active area in the right     and left superior temporal cortex, Broca's area, and the left temporoparietal cortex.     Shergill et al. reported the presence of active areas in the anterior cingulate cortex, right     thalamus, left hippocampus, and parahippocampal cortex when subjects were experiencing     auditory hallucinations.      Magnetic Stimulation of Left Temporoparietal Cortex suggest that the mechanism of auditory     hallucinations involves activation of the left temporoparietal cortex.Reasons to believe that     right frontotemporal TMS stimulation cortex can ameliorate auditory hallucinations include     evidence that right temporoparietal stimulation achieved significant changes in the frequency     of auditory hallucinations,in the patients with auditory hallucinations an increase in blood     flow is noted in the right superior temporal gyrus,right temporal lobe activation during     auditory hallucination,effect of rTMS can spread to the opposite hemisphere through     interhemispheric connections,some evidence that brain circuits involved in the production of     auditory hallucinations and symptoms of schizophrenia are widespread and not confined in the     left temporoparietal cortex.Deep TMS can reach brain structures as deep as 5 cm whereas     non-deep TMS can reach structures less than half that distance. As deep brain structures such     as thalamic, limbic and paralimbic regions have been shown to be activated during auditory     hallucinations and suspected to play a role in the pathogenesis of auditory hallucinations,     their stimulation may attenuate auditory hallucinations. Non-deep TMS can stimulate the     cortex but not the neuronal pathways connecting it to deeper brain structures and which     stimulation may be additive.   "
207293|NCT00564109|"     Retrospective analysis of PSP- and PAP-serum levels in trauma patients with soft tissue     defects and possible correlation with the incidence and onset of infection and sepsis.   "
207294|NCT00564122|"     This study will characterize the accuracy of a commercially available     artificially-intelligent stethoscope in determining which childhood murmurs suggest     underlying congenital structural heart disease and therefore warrant diagnostic     echocardiograms.   "
207295|NCT00564135|"     With the advent of minimally invasive surgery, laparoscopic assisted vaginal hysterectomy     (LAVH) is currently advocated as an alternative to abdominal hysterectomy. Reported benefits     of LAVH in short-term study, when compared with the abdominal hysterectomy, include shorter     hospital stays and convalescence, less postoperative pain, lower morbidity. To our best     knowledge, no study has been conducted to examine bladder catheterization is associated with     PUR and UTI after LAVH. No study has been performed to evaluate the long-term sequelae of PUR     after LAVH.      In this study, 150 patients undergoing LAVH are randomly assigned to have an indwelling Foley     catheter for 0 (n = 50), at 7AM-8AM in the morning of postoperative day 1 (n = 50), at     7AM-8AM in the morning of postoperative day 2 (n = 50) after the procedure by selecting a     sealed envelope, which is opened before the operation. The inclusion criteria are uterine     fibroids, endometriosis, abnormal bleeding, uterine prolapse and intra-epithelial neoplasia     of the cervix grade 3. Patients are excluded if they experienced pelvic reconstructive     surgery for pelvic organ prolapse or stress urinary incontinence; if they have bacteriuria     and clinical urinary tract symptoms, e.g. dysuria, frequency, urgency and stress incontinence     before surgery. After surgery, all patients stay at least 2 days in the hospital. The     incidences of febrile morbidity and other postoperative complications are recorded. The     outcome is assessed as immediate postoperative urinary tract symptoms, urinary tract     bacteriuria (defined as a positive culture > 105 organisms/µl), postoperative fever > 38°C     and urinary retention or the inability to pass urine 6 hours after catheter remove. All     patients are followed up at 3 months and one year after surgery. To demonstrate quality of     life of women after undergo LAVH, a generic instrument of MOS Short Form 36 (SF-36) and two     specific instruments for urinary problems, Incontinence Impact Questionnaire (IIQ7) and     Urinary Distress Inventory (UDI) are asked to answer in all patients before surgery and     postoperative follow-up. All data are analyzed by the two-tailed Fisher exact test when     appropriate. Correlation coefficients are calculated to determine the associations of     preoperative, intraoperative, and postoperative factors with the incidence of postoperative     urinary retention and positive urine cultures. A value of p < 0.05 is considered     statistically significant.   "
207296|NCT00564148|"     The study intends to assess the effect of Avastin injections in different proliferative     retinopathies due to different causes   "
207297|NCT00564161|"     We hypothesize that misexpression of vascular endothelial growth factor (VEGF) in the     Cerebrospinal fluid of preterm infants can be used as a biomarker to predict the risk for     developing white matter damage.   "
207298|NCT00564174|"     To compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies     randomized to either low molecular weight heparin plus aspirin versus aspirin alone.   "
207299|NCT00564187|"     Primary:        -  To evaluate the efficacy of two regimens of irbesartan in patients responding but not          normalized at 6 weeks of treatment (schema N°1: maintenance 150 mg/day, schema n°2: 300          mg/day for 6 more weeks)      Secondary:        -  To evaluate the percentage of patients with DBP < 90 mmHg at 6 and 12 weeks        -  To evaluate the percentage of patients with SBP < 140 mmHg at 6 and 12 weeks        -  To evaluate rate of adverse events during the study   "
207300|NCT00564200|"     The primary objective of this study is to analyze the efficacy of allogeneic bone marrow     transplantation in a reduced-intensity manner combined with bortezomib in the treatment of     multiple myeloma with bad prognosis, in order to evaluate the response and relapse rates   "
207432|NCT00557466|"     This study will evaluate the dose response relationship among four doses of indacaterol as     well as placebo delivered via the TWISTHALER® device.   "
207433|NCT00557492|"     This study is to determine the efficacy of bevacizumab and gemcitabine in combination with     radiation therapy in the preoperative treatment of potentially-resectable subjects with     pancreatic cancer.   "
207964|NCT00570063|"     To assess the efficacy and safety of an investigational compound PF-02545920 for the     treatment of schizophrenia. PF-02545920 will be more effective than placebo in reducing     symptoms associated with schizophrenia.   "
207301|NCT00564213|"     To evaluate and compare the effect of the prophylactic use of two different exposure times of     mitomycin C (MMC) 0.02% to inhibit haze formation after photorefractive keratectomy (PRK) for     high myopia (> -7.0 D).      Methods: Forty six eyes of twenty three patients, 8 men and 15 women, with high myopia were     included in this prospective study. Mean age at the time of PRK plus MMC was 31.7 years.     Before PRK, the mean spherical equivalent was -8.50 D (range, -7.25 to -10.50 D). In each     patient, one eye was randomly assigned to PRK and a single intraoperative topical application     of mitomycin C 0.02% for 15 seconds (Group 1) and the fellow eye, for 30 seconds (Group     2).The inclusion criteria were high myopia, no central corneal opacity and inadequate corneal     thickness to allow a safe Laser in situ keratomileusis procedure. Refraction, uncorrected     visual acuity, best spectacle-corrected visual acuity (BSCVA), and slit-lamp evidence of     corneal opacity (haze) were evaluated over 12 months   "
207302|NCT00564226|"     The primary objective of this study is to evaluate the efficacy of SSR240600C in women with     overactive bladder compared to placebo using tolterodine as a study calibrator.   "
207303|NCT00564239|"     The purpose of this study is to determine whether cognitive-behavioral group prevention     (CBT-G) for german children is effective and to what extent parental group training moderates     outcome.   "
207304|NCT00564252|"     the purpose of this study is to evaluate the efficacy of topical Finasteride in the treatment     of idiopathic hirsutism   "
207305|NCT00564265|"     This is a retrospective analysis and description of the preferred diagnostic and treatment     methods employed on GIST on the Region of Coquimbo from 2003 to 2008.   "
207306|NCT00564278|"     This study will evaluate the effectiveness of adding motivational interviewing to     antidepressant treatment for major depressive disorder in Hispanic adults.   "
207307|NCT00564291|"     Comparison of different OCT instruments to assess retinal thickness, correlation to     fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy   "
207308|NCT00564304|"     Nasal Potential Difference measurements (NPD) have been performed in Israel since 1996. NPD     measurements are used to assess the voltage across nasal epithelium, which correlates with     the transport of sodium and chloride across cell membranes. NPD was first demonstrated to be     abnormal in Cystic Fibrosis (CF) in 1981 and the technique has since been used to increase     our understanding of this condition. It is now established as an important diagnostic tool     and more recently has been used to assess the effectiveness of new treatments such as gene     and alternative therapy (Knowles 1995; Wilschanski 2003).      The nasal cavity is accessible which makes it a good site to examine the ion transport     characteristics of airway epithelia. Less than a centimetre into the nose the squamous (skin     type) epithelium becomes ciliated pseudocolumnar epithelium, characteristic of the proximal     airways.      The change in NPD with the perfusion of different solutions is demonstrated. By employing NPD     protocols with perfusion of different solutions and drugs, different aspects of the nasal ion     transport characteristics can be examined. In CF, this ion transport profile is abnormal and     the NPD measurement has a number of features that differentiate CF from non-CF. This     methodology is well established for measurements in subjects over 6 years of age.      Measurements on smaller children and infants have been very difficult to perform. We propose     a new method using smaller, single lumen catheters with much lower perfusion rates (0.2     ml/min compared to up to 5 ml/min with the adult method) .Perfusion measurements will be     possible in newly born infants. Obviously this opens up the potential for using NPD as a     diagnostic test in babies. This is important as the diagnosis of CF is often difficult to     make or refute in babies because of the problems in collecting enough sweat. This may be the     ideal diagnostic test for CF in the neonatal nursery in infants with meconium plug syndrome.   "
207309|NCT00564317|"     The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation     protocol in treating traumatized children when applied by locally trained teacher counsellors     as well as the effectiveness and adequacy of such a treatment in a south-asian war affected     stayee child community.   "
207310|NCT00564330|"     Dental erosions in 30 male and female patients with proven abnormal gastrooesophageal reflux     will be assessed clinically and using a novel optical coherence tomography (OCT) laser     technique before and after double-blind randomization to antisecretory treatment with     esomeprazole 20mg or placebo bid for 3 weeks.      The primary objective is to quantify tooth substance loss as well as changes in optical     reflectance and scattering of dental hard tissues with and without acid inhibition.      Secondary objectives are:      To compare standardised visual scoring with OCT quantification of reflux damage at the     different time points on different teeth.      To assess sex differences in OCT- quantified dental tissue loss.   "
207311|NCT00564343|"     The proposed project is a case control study design. Subject's suffer from stroke willing to     participate in the study will be shortly interviewed to assess eligibility according to the     inclusion-exclusion criteria. Subjects suffer from chronic hemiplegia that upon questioning     was judged to meet the following inclusion criteria: (a) able to stand independently 90     seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal     instructions. The exclusion criteria will be: (a) Serious visual impairment; (b) Inability to     ambulate independently (cane acceptable, walker not). (c) Severely impaired cognitive status     (score less then 24 in Mini Mental State Examination). (d) Persons with impaired     communication capabilities.      The whole project will be conducted over a period of 3 months. A total of 36 subjects will be     assigned to water based exercise program. The exercise group will meet on 24 occasions over a     period of 12 weeks (2 times/week). The subjects of the exercise group will be recruited from     Sha'ar Ha'negev Swimming pool and from patients that get a Physical Therapy treatment Kupat     Holim Clalit.      Gait and balance function will be tested in both groups with well established measuring     techniques before and after the training period. The measuring techniques 1) Medical     background variables. 2) Berg Balance Scale. 3) Late life Function and Disability Instrument.     4) Get up and go test - stand up and walk 3 meters turn around and walk back to the chair. 5)     step execution test under single and dual task; 5) stability tests. 6) also fall will be     monitored a year after the completion of the study. The water training intervention is     performed on different levels where each level reflects different increasing demands on the     postural control system. For example, the instructor can increase the difficulty of a certain     water-exercise by instructing a participant to use less external support, close the eyes,     decrease the support area (stand on one leg or narrow the stance, or on unstable surface).     These tools allow the instructor to implement step exercises on a group level that are     still challenging for each individual even if the skill level in the group varies. The water     exercises also include perturbation exercises that trigger specific reflex-like balance     responses. On each level the instructor can instantly modify an exercise to be more or less     challenging for each participant.   "
207312|NCT00564356|"     To assess the risks of intra- and postoperative bleeding tendency associated with cataract     surgery by phacoemulsification in patients on coumadin and antiaggregant treatments.      Design: Consecutive prospective study.   "
207402|NCT00557037|"     Two groups of patients with prostate cancer will be enrolled:      Group A: patients whose cancer has worsened or spread after being on hormonal therapy and has     not had any chemotherapy.      Group B: patients who have a rising PSA after surgery or radiotherapy for the prostate and do     not have any spread to the bones or other organs.      Patients will receive Phenoxodiol (PXD) 400 mg every 8 hours daily for 28 consecutive days (1     cycle). Treatment outcome will be evaluated after three cycles (12 weeks) of PXD treatment     (immediately prior to cycle 4). Patients with progression of disease will be taken off study.     Responding and stable disease patients will remain on study for a total of 12     cycles(approximately 12 months).   "
207313|NCT00564369|"     Advocacy groups have voiced concerns about the ethics of some of tenets of the CDC's new HIV     testing recommendations for the healthcare setting. Three concerns are paramount: (1) the     opt-out approach to HIV testing can potentially be coercive and not truly voluntary; (2) by     replacing informed consent with general consent for medical care, test participants might not     know or be adequately informed of the benefits and consequences of testing; and (3)     eliminating HIV prevention counseling from the HIV testing process presumes that test     participants are aware of how to prevent an HIV infection, which might not be correct. This     study involves conducting interviews of HIV advocates who are raising these concerns,     surveying outpatient and emergency department clinical providers about their beliefs and     opinions regarding the tenets of the new guidelines, and then conducting a multi-center,     randomized, controlled trial in which the ethical concerns of opt-out vs. opt-in testing are     directly compared. We will conduct a multi-center, randomized, controlled, trial whereby     patients will be surveyed on their perspectives and perceptions regarding opt-out or opt-in     rapid HIV testing. We will survey the participants regarding their perception of coercion,     their understanding of the elements contained in the informed consent process, their HIV risk     factors, and their knowledge of HIV prevention. We will evaluate whether or not the     CDC-recommended approaches regarding opt-out testing, consent, and decoupling of prevention     counseling are supported. If there are no differences regarding these ethical concerns     between testing approaches, then the opt-out approach would be considered not to be inferior     to the opt-in approach.   "
207314|NCT00564382|"     In this study, we investigate the role of Cardiac Magnetic Resonance Imaging in patients with     suspected, but not yet proven, acute cardiac syndrome ACS. Patients are included if they     presented to the local Emergency Department with chest pain, but the first tests in the     Emergency Department are negative or not clearly indicative of cardiac ischemia. For example,     the first lab value Troponin T is negative or borderline elevated; or the first ECG is not     clearly indicative of ischemia. The standard procedure for these patients is to wait 4-6     hours and then repeat the test; if they continue to be negative, the patients are discharged     home, if the have become positive, an invasive coronary artery angiography has to be     performed. We think, that a CMR study can shorten the time needed to make the decision of     either discharge or admit to CCU and perform a coronary artery angiography. CMR has been     shown to be the gold standard for heart function (thus, can see even subtle wall motion     abnormalities), for tissue characterization (so-called T2-weighted images can identify tissue     edema (swelling); perfusion images can identify areas with reduced blood supply; late     enhancement images can safely identify fibrotic or irreversibly damaged tissue) and can even     be used to stress the patients to exclude a critical or non-critical narrowing of coronary     arteries.      The primary endpoint of this study will be the impact of CMR on the time-to-decision in these     patients.      It should be possible to a) identify all patients WITH an acute infarct by CMR and send them     to a cath lab sooner compared to waiting for a second test; b) identify all patients WITHOUT     an acute infarct and c) perform a stress test in those patients to exclude severe coronary     artery disease.   "
207315|NCT00564395|"     We study blood sugars in the children with T1DM, who are given insulin detemir and a rapid     acting insulin. We hypothesize that there is no difference in the patterns of blood sugars     when detemir is given in the same syringe or in separate syringes with rapid acting insulin.   "
207316|NCT00564408|"     The purpose of this study is to test if carbachol infusion induces headache in migraine     subjects as well as intra- and extra-cerebral vasodilatation.   "
207317|NCT00564421|"     The purpose of this study is to determine the safety and efficacy of epinastine nasal spray     compared to placebo for the treatment of subjects with seasonal allergic rhinitis   "
207318|NCT00564434|"     Risk factors for postoperative delirium in hip fracture patients.   "
207319|NCT00564447|"     The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to     Vigamox at various time points in conjunctiva tissue of healthy volunteers   "
207320|NCT00564460|"     Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic     hyperplasia (BPH). A common complication of TURP is blood loss. Preliminary data suggest that     preoperative Finasteride, a 5 alpha-reductase inhibitor, may reduce blood loss during TURP.     However, no study has examined the effect of preoperative Finasteride on clinical outcomes.      The study is a randomized, double-blind, placebo-controlled trial of preoperative Finasteride     versus placebo in BPH patients undergoing TURP. Participants will be stratified by prostate     volume (30 to 65 grams versus 66 to 100 grams) and randomly assigned to preoperative     Finasteride or placebo. The primary end point is incidence of RBCT. Secondary end points are     standard units of red blood cells transfused, variables related to perioperative bleeding     (incidence of readmission, incidence of return to hospital, length of hospital stay), blood     loss, change in serum hemoglobin, change in serum hematocrit, blood loss per gram of resected     prostate tissue, operating time, change in AUA-SS, and change in HRQOL.   "
207321|NCT00564473|"     Herbs are physiologically active substances which can significantly affect the outcome of     medical treatment, either by inhibiting or promoting drug disposition or through additive and     synergistic effects when used in conjunction with conventional medications. Herb-drug     interactions are potentially dangerous, and may be difficult to predict since regulation of     the preparations is often lacking, and patients most often do not report the use of these     products to their physicians. The risk for toxic effects and adverse interactions increases     among high-risk groups, such as the elderly or patients with renal or hepatic disease. The     purpose of this study is to study the prevalence of use of herbal medicine among patients     hospitalized in the internal medicine department of an Israeli hospital, as well as examine     the effect of herbal remedies on patient health, either beneficial or harmful. For this     purpose, a questionnaire evaluating demographic data, medical history (both current and     past), use of and attitudes towards herbal medicine will be administered to patients in the     Department of Internal Medicine at the Shaare Zedek Medical Center in Israel. The Beck     Depression Questionnaire will be used as well.   "
207322|NCT00564486|"     This research study will look at the pain relieving ability and safety of using repeated     doses of intravenous (into the vein [IV]) acetaminophen in the treatment of moderate     postoperative pain after planned or elective abdominal laparoscopic surgery, such as a     laparoscopic abdominal hysterectomy or laparoscopic cholecystectomy (removal of the gall     bladder).   "
207324|NCT00564512|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in     different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such as     rituximab and alemtuzumab, can block cancer growth in different ways. Some find cancer cells     and help kill them or carry cancer-killing substances to them. Others interfere with the     ability of cancer cells to grow and spread. It is not yet known whether giving fludarabine     and cyclophosphamide together with rituximab is more effective than giving fludarabine and     cyclophosphamide together with alemtuzumab in treating B-cell chronic lymphocytic leukemia.      PURPOSE: This randomized phase III trial is studying giving fludarabine together with     cyclophosphamide and rituximab to see how well it works as first-line therapy compared with     giving fludarabine together with cyclophosphamide and alemtuzumab in treating patients with     B-cell chronic lymphocytic leukemia.   "
207325|NCT00564525|"     The purpose of this study is to determine where amitriptyline is effective in the treatment     of functional abdominal pain in children.   "
207326|NCT00564538|"     The purpose of this study is to compare kidney function, long term patient and graft     survival, and incidence of acute rejection in liver transplant recipients between one group     receiving thymoglobulin induction and delayed initiation of tacrolimus and another group of     liver transplant recipients having immediate administration of tacrolimus without any     induction immunosuppression.   "
207327|NCT00564551|"     The purpose of this study is to determine if increased intake of low-fat milk products and     calcium as part of a calorie restricted diet helps achieve a healthier body weight and body     composition and decrease blood glucose levels in people with insulin resistance or type 2     diabetes.   "
207328|NCT00564564|"     The objective of this trial is to compare in an open trial format the efficacy of association     of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete     remission of obsessive compulsive disorder symptoms.   "
207329|NCT00564577|"     This will be a strain and dose-finding study in which LSN03-016011/A ETEC will be     administered at a starting inoculum of 5x108 cfu to 5 subjects to establish a human disease     model. If 80% attack rate (AR) is achieved without high output diarrhea, the same inoculum     will be given to 10 more subjects for confirmation of AR. If 80% AR is not achieved, attack     rate and severity of disease will be evaluated to determine if the dose should be increased.     The same sequence may be conducted with WS6788A if applicable. If the LSN strain causes high     output diarrhea the dose will be adjusted down and further dose characterization continued.     An iterative process will be used to select the optimal strain and dose with each step     reviewed and approved by the medical monitor.   "
207330|NCT00564590|"     We hypothesize that melatonin as compared to PPI and to placebo, improves GERD symptoms by     decreasing esophageal acid exposure and esophageal acid sensitivity in GERD. We hypothesize     that melatonin as compared to PPI and to placebo reduce the frequency and duration of     transient lower esophageal sphincter relaxations (TLESRs). In addition we hypothesize that     melatonin as compared to PPI and to placebo improves quality of life and quality of sleep of     GERD patients.   "
207331|NCT00564603|"     Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination     of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v.     basal infusion of tramadol is a certified technique in postoperative pain management. We     purposed that combined administration of dexamethasone and tramadol adjunct to i.v. morphine     is an effective way in treating postoperative pain.   "
207332|NCT00564616|"     The purpose of this study is to determine whether adding interactive video communication to     dispatch instruction improves the quality of bystander cardiopulmonary resuscitation in     simulated cardiac arrests.   "
207333|NCT00564629|"     To assess the rapidity of onset of antipyretic effect and the efficacy and safety of a single     dose of IV acetaminophen (IV APAP) versus oral (PO) acetaminophen in the treatment of fever     induced by a standard dose of endotoxin   "
207334|NCT00564642|"     Tuberculosis is one of the major health problems in developing countries. Isoniazid, rifampin     and pyrazinamide, the first line drugs used for tuberculosis chemotherapy, are associated     with hepatotoxicity. The rate of hepatotoxicity has been reported to be much higher in     developing countries compared to that in advanced countries with a similar dose schedule.     Oxidative stress has proposed as one of the mechanisms responsible for anti-tuberculosis     drugs induced hepatic injury. The oxidative stress is closely associated with decrease of     glutathione levels. In the present study N acetylcysteine, a precursor of glutathione, was     investigated for hepatoprotective effect against anti-tuberculosis drugs induced liver     injury.   "
207335|NCT00564655|"     The objective of this trial is to examine if regional anesthetic blockade of the anterior     abdominal wall via the transversus abdominis plane is a safe and feasible method of providing     analgesia for children undergoing gastric tube insertion.   "
207336|NCT00564668|"     This trial is conducted in Japan. The aim of this trial was to investigate the safety and     efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced     by current process in Japanese subjects with type 2 diabetes.   "
207337|NCT00564681|"     Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale     (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and     placebo.   "
207338|NCT00564694|"     RATIONALE: Collecting information about the quality of life of patients with colorectal     cancer may help doctors learn more about the disease.      PURPOSE: This clinical trial is studying the European Organization of Research for the     Treatment of Cancer (EORTC) quality-of-life-questionnaire in patients with colorectal cancer.   "
207351|NCT00564863|"     This will be a strain and dose-finding study in which CS19-ETEC strain WS0115A will be     administered at a starting inoculum of 5 x 108 colony forming units (cfu) to 5 subjects as     the initial step to establish a human disease model. If an 80% attack rate (AR) for     predefined diarrheal disease is achieved without high output diarrhea, the same inoculum will     be given to 5 - 10 more subjects for confirmation of AR. If an 80% AR is not achieved, AR and     severity of disease will be evaluated to determine if the dose should be increased. The same     sequence may be conducted with DS26-1 as necessary. If the WS0115A strain causes high output     diarrhea, the dose will be adjusted down and further dose characterization continued. An     iterative process will be used to select the optimal strain and dose with each step reviewed     and approved by the medical monitor.   "
207339|NCT00564707|"     Purpose: To assess whether EMG directed biofeedback therapy or Botulinum toxin type A     injection of the levator ani muscles has any effect on pain from the levator ani syndrome,     and, in addition, to what extent either treatment is superior to the other in terms of     anorectal physiologic measurements, and quality of life.      Study Design: Randomized, prospective, unblinded double-armed study with crossover.      Methodology: Female subjects, aged 18 and over, with painful levator ani muscle spasm for at     least one month duration will be randomized to receive either biofeedback therapy or     Botulinum toxin type A injection. After randomization they will all undergo visual analog     pain scoring, anorectal manometry, colonoscopy (if clinically indicated), and self-reported     SF-36 quality of life measurement. Each patient will also complete numerical pain scale     scoring, an SF-36, and a satisfaction questionnaire at each treatment visit and follow-up     visit. Patients will submit these by mail. Identification numbers will be assigned to each     subject for use on the SF-36 and Satisfaction Questionnaires throughout the study. Subjects     will again undergo anorectal manometry at the end of their treatment arms. In the biofeedback     arm patients will be treated biweekly for up to eight treatments and be provided exercises to     practice at home based on their muscle function noted during the biofeedback training     session. Subjects will keep a treatment diary of the exercises they do at home to help ensure     compliance with the protocol. In the Botulinum toxin injection arm patients will be treated     with scheduled injections of the levator ani muscles every six weeks for up to three total     injections of 100U each. These injections will be directed to the painful areas of the     levator muscles as guided by physical exam and EMG measurements. Should any patient fail     their initial randomized treatment assignment (failure defined as very dissatisfied or     dissatisfied on the satisfaction questionnaire), they will then be allowed to cross over to     the other study arm. In addition to numerical pain scale scoring, an SF-36 questionnaire and     anorectal manometry will also be repeated at the time of crossover. We intend to include all     randomized patients in the final data analysis (according to their originally assigned     treatment arm), regardless of outcome or reason for dropout, thus making this an     intent-to-treat analysis.      Pivotal Study Definitions: The definition of adequate pain reduction, for the purposes of     data analysis, will be a reduction in a subject's mean pain score of two on a numerical pain     scale (0-10). Failure of either therapy will be defined as a response of very dissatisfied     or dissatisfied on the satisfaction questionnaire at the end of either biofeedback (eight     treatment visits) or Botulinum toxin (three injections) both before and after crossover.      Outcomes: We will determine the following for biofeedback therapy and Botulinum toxin type A     injection: mean pain reduction, any differences in anorectal physiologic measurements (such     as mean resting anal sphincter pressure), any changes in self-reported quality of life, and     overall patient satisfaction.   "
207340|NCT00564720|"     This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus     Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic     cancer.   "
207341|NCT00564733|"     This phase II trial studies how well fludeoxyglucose F 18 (FDG)-labeled positron emission     tomography (PET) scan works in planning chemotherapy in treating patients with stage IIIB or     IV non-small cell lung cancer (NSCLC). Drugs used in chemotherapy, such as paclitaxel,     carboplatin, gemcitabine hydrochloride, and docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Diagnostic imaging procedures, such as FDG-labeled PET scan, may help in guiding chemotherapy     and allow doctors to plan better treatment   "
207342|NCT00564746|"     SB-681323 is a p38 MAP kinase inhibitor and is currently under development by     GlaxoSmithKline. This will be an open label study conducted at one site. Six healthy male     subjects will be enrolled to ensure at least four fully evaluable subjects. Each subject will     receive a single 10mg/ 50 µCurie oral dose of [14C]SB-681323. Urine and faecal samples will     be collected until 216 h after dosing but subjects may be discharged after 168 h if 90% of     the dose is recovered and/or <1% of the dose is excreted in a 24 h period. Blood and plasma     will be collected at various sample times after dosing to measure parent drug and total     drug-related material. Samples of urine, faeces and plasma will be transferred into separate     study to characterise and quantify metabolites in these matrices. Safety will be assessed by     adverse event monitoring, vital signs, ECG and clinical laboratory tests.   "
207343|NCT00564759|"     The aim of the study is to evaluate the side effects and risks after infusion of retroviral     gene corrected autologous CD34+ cells of the peripheral blood of chemotherapy conditioned     (busulphan)patients with chronic granulomatous disease (CGD). Also gene corrected and     functional active granulocytes in the peripheral blood and the engraftment in the bone marrow     of the patients will be monitored an documented.   "
207344|NCT00564772|"     This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female     subjects of the pharmacokinetic interaction between raltegravir and Kaletra.   "
207345|NCT00564785|"     We hypothesized that the analgesic effect of Synera™ analgesic patch would be superior to     traditional infiltration with lidocaine for pain of epidural needle insertion in laboring     parturients.   "
207346|NCT00564798|"     Shapedown BC is being implemented at a single centre (BC's Children's Hospital). We will use     the data routinely collected by the Shapedown program and evaluate the effect of the program     and whether any changes are sustained for up to 2 years. A group of subjects who expressed     interest in the program but ultimately decided not to participate will be used as a reference     group.   "
207347|NCT00564811|"     The aim of the study was to verify the influence of Agaricus blazei (Murrill) ss. Heinemann     (A. blazei) on the evolution of nutritional state and liver function in hepatitis C patients.   "
207348|NCT00564824|"     Prior work (Chris, M. et al, Clinical Science 2005; 109, 55-60) has demonstrated that     drinking a cup of coffee (80-100 mg of caffeine) an hour before endothelium-dependent FMD     (flow-mediated dilatation) of the brachial artery, effects endothelial function in healthy     adults subjects.      This effect might be attributed to caffeine, given that decaffeinated coffee (<2 mg of     caffeine) was not associated with any change in endothelial performance.      In the current study we intend to further examine the impact of caffeine on brachial     endothelial function among healthy subjects & in patients with proven ischemic heart disease.   "
207349|NCT00564837|"     This study was designed to determine whether or not there were any differences in knee range     of motion, both statically and during gait, sagittal plane knee laxity, and quadriceps and     hamstrings strength in patients three months post-ACL reconstruction with a bone-patellar     tendon-bone autograft based on their performance of a primarily home based rehabilitation     program or a standard physiotherapy-supervised program.   "
207350|NCT00564850|"     The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the     delay of premature onset of puberty in girls less than 9 years and boys less than 10 years.     This is measured by assessing the proportion of children who have a suppressed Luteinizing     Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after     injection with triptorelin 11.25 mg.   "
207393|NCT00556907|"     We hypothesize that the combination of mammography and CE-MRI will improve the surgeon and     radiologist's ability to define extent of disease prior to surgical resection, improve the     odds of obtaining clear surgical margins, and increase the efficacy of IORT delivered     immediately after initial surgical resection. In this investigation, we will determine     whether or not patients deemed eligible for 'immediate IORT based on mammography and CE-MRI     can be successfully treated without the need for re-excision or additional radiotherapy due     to inadequate surgical margins.   "
207394|NCT00556920|"     This study will be a randomized study investigating the bioequivalence of COREG CR and     Lisinopril to COREG CR and ZESTRIL   "
207352|NCT00564876|"     Src expression has been identified in a majority of Non-Small Cell Lung Cancer (NSCLC) cell     lines and there is preclinical evidence that Src family kinases may be important in hypoxic     growth and angiogenesis in NSCLC. We hypothesize that the inhibition of Src pathway with     dasatinib will demonstrate anti-tumor activity in early stage NSCLC, with a tolerable safety     profile.      Patients will receive dasatinib, a Src inhibitor, for 3 weeks prior to surgical resection for     early stage NSCLC. Fresh frozen tumor tissue is needed for genomic analysis. If fresh frozen     tumor tissue is not available from the initial diagnosis, a biopsy will be required to     participate in this trial. A second tumor sample will be obtained at time of surgical     resection to evaluate for changes in genomic expression profiles.      Patients will be eligible to receive 3 months of adjuvant dasatinib therapy after completion     of standard adjuvant therapy or after recovery from surgery if no standard adjuvant therapy     is given, if there is evidence of neoadjuvant tumor response (radiologic and/or pathologic)     to dasatinib.      Many patients who present with NSCLC are active smokers. Patients who are smoking up until     the time of their surgery experience increased peri-operative complications compared to     patients who have not smoked cigarettes immediately prior to surgery. While this trial will     not be limited to active smokers, the period of smoking cessation prior to surgery is an     attractive window of opportunity during which the potentially active novel anticancer therapy     dasatinib can be offered to the patient.   "
207353|NCT00564889|"     RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in     different ways and stop plasma cells from growing. Drugs used in chemotherapy, such as     cyclophosphamide and dexamethasone, work in different ways to stop the growth of plasma     cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide     together with cyclophosphamide and dexamethasone may be an effective treatment for primary     systemic amyloidosis.      PURPOSE: This phase II trial is studying how well giving lenalidomide together with     cyclophosphamide and dexamethasone works in treating patients with primary systemic     amyloidosis.   "
207354|NCT00564902|"     To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to     patients with early and moderate Atrophic Age Related Macular Degeneration.   "
207355|NCT00564915|"     A study of the efficacy and tolerability of two different ketogenic diets in children with     drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet     after baseline or after further 3m control period; in addition randomised to either MCT or     classical ketogenic diet.   "
207356|NCT00564928|"     To determine:        -  Anti-tumor activity of IPI-504 in 2 groups of subjects with hormone resistant prostate          cancer.        -  Group A - subjects who have not previously received chemotherapy        -  Group B - sujects who have received prior chemotherapy or could not tolerate          chemotherapy.        -  Clinical response will be determined by PSA and radiological response   "
207357|NCT00564941|"     This study will evaluate the safety and efficacy of deferasirox in transfusion dependent     Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload   "
207358|NCT00564954|"     This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo     during an 8-hour laboratory classroom day.   "
207359|NCT00564967|"     Social phobia is one of the most prevalent anxiety disorders in the western world. Cognitive     behavioural therapy (CBT) is the psychological treatment that has the largest empirical     support. However, the availability to CBT is very limited in Sweden due to lack of therapists     with proper training. Therefore it is important to evaluate alternative forms of treatment     that are more time efficient. One of these methods is Internet based self-help therapy, which     has proven to be an effective treatment for social phobia.      To the investigator´s knowledge, no study has yet directly compared live-CBT to Internet     therapy. The aim of the present study is to compare the effect of live CBT vs CBT delivered     via the Internet. The study is considered to be an equivalence trial. 128 patients will be     randomly assigned to one of the two treatment conditions. The primary outcome measure is     Liebowitz Social Anxiety Scale (LSAS).   "
207360|NCT00564980|"     The purpose of this study is to evaluate two different currently accepted surgical treatments     for UAS (ulnocarpal abutment syndrome).      The hypothesis is that ulnar shortening osteotomy procedure will be associated with longer     surgical time and increased complication rate when compared to the wafer procedure. It is     unclear as to whether there will be a difference in functional outcome between the two     groups.   "
207361|NCT00564993|"     Summary:      The investigators aim to identify markers of right ventricular dysfunction in patients with     severe pulmonary regurgitation following repair of Tetralogy of Fallot, that allow prediction     of the optimal timing of the replacement of the regurgitant valve. The investigators will use     MR as a gold-standard reference for measurement of cardiac function during rest and     dobutamine stress. The investigators will also evaluate the predictive potential of tissue     Doppler imaging in this patient group.      Purpose:      To predict the optimum timing of pulmonary valve replacement for severe regurgitation in     repaired Tetralogy of Fallot using Cardiac Magnetic resonance with dobutamine stress testing.   "
207362|NCT00565006|"     This study will investigate the influence of MK0859 on ambulatory blood pressure, and how     safe and tolerable MK0859 is on the subjects This is an early phase trial and some specific     protocol information is in progress and not publicly available at this time. (Full     information is available to trial participants).   "
207395|NCT00556933|"     This 2 x 2 sequential factorial study evaluates two potential improvements to the standard     immunosuppression regimen used at the investigators' institution to prevent rejection of     transplanted kidneys. These two potential improvements are each applied in sequence to half     of the study patients, creating 4 study arms; the other half receive the standard treatment.     The two potential improvements are:        1. Administering the immunosuppression induction agent rATG (rabbit anti-thymocyte          globulin) in a single dose at the time of transplantation, instead of in the usual          series of 4 smaller doses over 6 days.        2. After 6 months, modifying the maintenance immunosuppression used to prevent rejection by          replacing the drug tacrolimus with mycophenolate mofetil (MMF).      The two interventions, spaced sequentially six months apart, enable independent analysis of     the two treatments so long as it can be shown that there is no synergistic interaction     between them.   "
216431|NCT00683436|"     This will be a multi-center, randomized, blinded, comparative, placebo-controlled, 4 arm     crossover study in patients with primary insomnia.   "
207363|NCT00565019|"     Background:      Dupuytren's contracture is a common hand problem that causes certain fingers to bend towards     the palm. Patients with this condition cannot perform daily activities and many are unable to     work. It is usually treated by an operation to straighten the fingers followed by therapy if     the angle that the fingers are bent at is large enough. However, no treatment has been able     to completely prevent the angle from persisting.      Objective:      This study is designed to examine whether or not the use of a drug in combination with     surgery will improve the angle at which the fingers are bent more than surgery alone.      Hypothesis:      Subjects who receive triamcinolone acetonide will have straighter fingers compared with     subjects who only have the operation and no triamcinolone acetonide at both 3 months and 6     months after the operation.      Methods:      Eligible patients interested in having the operation to treat Dupuytren's contracture will be     asked if they would like to join the study. Subjects will be randomly placed into one of two     groups: the steroid injection group or the control group. Subjects will have a pre-operative     visit, the surgery, and follow-ups at 6 weeks, 3 months and 6 months. All subjects will have     the operation, but only those in the steroid injection group will receive an injection of the     drug. During the 6 week and 3 month follow-ups, subjects in the steroid injection group may     receive another injection if their fingers are still bent. Angles are measured at the     pre-operative visit and at 3 and 6 months. The change in angle from before to after and any     differences in the groups, in time points and interactions between the two will be analyzed.   "
207364|NCT00565032|"     Women with abnormal serum thyroid antibody levels or abnormal TSH and/or T4 values are more     likely than their normal counterparts to have higher scores on a common postpartum depression     screening test.   "
207365|NCT00565045|"     Impaired hand function is one of the most frequently persisting consequences of stroke. The     purpose of this study is to investigate whether two different types of treatment improve     recovery of hand function after stroke.   "
207366|NCT00565058|"     This is a Phase II trial conducted at multiple centers for evaluation of the pharmacodynamic     activity and the overall response rate contributed by the combination agents of GTI-2040 and     High Dose Cytarabine (HiDAC) in Refractory and Relapsed Acute Myeloid Leukemia (AML).   "
207367|NCT00565071|"     The purpose of this study is to compare the cost-effectiveness of treating malaria based on     three methods of diagnosis (rapid test, microscopy and presumptive diagnosis) among patients     attending level three government health centres located in areas of low and high transmission     intensities in Uganda. The study hypotheses are: in both low and high transmission areas,     cost-effectiveness of malaria treatment with Artemether-Lumefantrine will be improved by the     adoption of rapid diagnostic tests when compared with presumptive diagnosis or microscopy;     and the difference between the cost-effectiveness of Artemether-Lumefantrine treatment     following rapid diagnostic test or microscopy versus presumptive diagnosis will be greatest     in low transmission areas.   "
207368|NCT00565084|"     The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee     pain during a series of timed walks on a treadmill.   "
207369|NCT00565097|"     To assess the efficacy of lanreotide in controling total liver volume in patients with     polycystic livers this study will be performed. A minimum of 38 patients will be recruited     and randomized (1:1) to receive either verum or placebo. Lanreotide is already used in other     disease states and found to be safe and non-toxic.   "
207370|NCT00565110|"     The ADAPt-C collaborative depression care model is designed to: improve depression symptom     reduction in the intervention group over the modestly enhanced usual care group of     low-income, predominantly Hispanic, patients with cancer who are receiving care in an urban     public sector care system; and to improve quality of life outcomes among intervention     patients over enhanced usual care.   "
207371|NCT00565123|"     The aim of the study is to evaluate the clinical and microbiological efficacies of three     times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent     dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3     days) in patients with bacterial conjunctivitis.   "
207372|NCT00565136|"     The study purpose is to gain experience with the TOPAS system, a minimally- invasively     delivered self-fixating mesh for the treatment of pelvic floor weakness in women with     symptoms of moderate fecal incontinence   "
207373|NCT00565149|"     This study is designed to determine the effects of dietary protein content on overfeeding.   "
207374|NCT00565162|"     To introduce initiation of glargine insulin treatment in primary care based on a patient     education program. To show and compare feasibility of group education to individual education     program.   "
207375|NCT00565175|"     The purpose of the study is to investigate whether blockade of the histamine H2 receptors in     the brain will have any beneficial effect on the symptoms of subjects with schizophrenia.   "
207376|NCT00565188|"     Palliative care in cancer aims at alleviating the suffering of patients. A previous study in     patients with advanced non-small-cell lung cancer showed that adenosine 5'-triphosphate (ATP)     infusions had a favourable effect on fatigue, appetite, body weight, muscle strength,     functional status, quality of life, and survival. Based on these promising results, the     present study was designed 1. To evaluate whether the beneficial effects of ATP     administration observed in patients with advanced lung cancer would also be present in     pre-terminal cancer patients of different tumour types, and 2. To test the feasibility of     application of ATP infusions in a home care setting.   "
207396|NCT00556946|"     This research study was designed to determine the effect on port wine stains (PWS) of     liposomal benzoporphyrin derivative monoacid (BPD-MA) termed verteporfin by intravenous (IV)     infusion for photodynamic therapy (PDT) or combined PDT and pulsed dye laser (PDL) therapy     (PDT + PDL). The standard treatment for PWS is PDL alone. This lightens some PWS but many     lesions are not completely removed.      PDT uses a medication and light together to cause injury to a target. The medication is given     and then light is directed at the desired area of treatment to achieve an effect. PDT has     been used to treat some skin conditions including pre-cancers and skin cancers. Using PDT or     PDT immediately followed by PDL therapy may improve PWS lightening. At this time, both PDT     and PDT + PDL therapy for treatment of PWS is investigational. The type and amount of     medication and light which may be used to treat PWS is not known, and is likely to be     different than those used for other PDT treatments.   "
207377|NCT00565201|"     The present study is designed to determine the safety and effectiveness of injections of     BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would     do nothing) when combined with rehabilitation therapy for the improvement of active function     tasks in post-stroke patients. Injections will be targeted to reduce common spasticity     patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist,     thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory     University. Neither the doctor injecting the drug nor the subject receiving the drug will     know if they are getting BOTOX® or saline. Which type of injection the subject receives will     be completely randomized (like flipping a coin). All subjects will have rehabilitation     therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits     (qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects     will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5     times a week, for 4 weeks. The results from this project will provide valuable data on the     ability of BOTOX® and physical rehabilitation to provide effective treatment to spastic     muscles of the arm and hand after stroke. This project has the potential to increase the     availability of effective rehabilitation techniques to patients with stroke.   "
207378|NCT00565214|"     Smoking damages the airway epithelium. The major mechanism by which this is done is by     molecules called free radicals. Our body attempts to deal with these damaging molecules in     two ways. One mechanism is via the presence of protective anti-oxidant vitamins and the other     is via proteins that are produced by the body to convert free radicals to safer, less     reactive molecules. Vitamins in our diet play a significant role in antioxidant defenses by     directly neutralizing the damaging free-radicals and by providing co-factors to cellular     proteins that neutralize the free radicals. This project is designed to look at the effects     of giving individuals supplemental vitamins to see if it improves their defenses against     oxidant insults. The investigators plan to look at the effects of these supplements over a 30     day period and monitor the effects by measuring vitamin levels in the blood and in the lung,     and by measuring the response of cells in the lung through the increase or decrease in     expression of genes responsive to oxidants.      To participate in this protocol, the research subject should first be enrolled in Weill-IRB     protocol #0005004439 entitled Evaluation of the Lungs of Normal (Smokers, Ex-smokers,     Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and     Bronchial Wall Biopsy, fulfilling the inclusion/exclusion criteria of that protocol. They     will be invited to participate in this Vitamin protocol only if they meet the additional     inclusion/exclusion criteria of this protocol.   "
207379|NCT00565227|"     Vorinostat (Suberoylanilide Hydroxamic Acid; NSC 701852) is a drug that inhibits an enzyme     that plays a key role in the regulation of cell survival, growth, and eventual cell death,     all of which play a role in cancer. As a result, this drug has the potential to affect a     tumor's ability to survive. Vorinostat is the most potent drug of its kind that is currently     under investigation in clinical trials. The primary objective of this study is to define the     maximum safest dose of vorinostat in combination with a standard chemotherapy agent,     docetaxel, in patients with advanced and relapsed lung, bladder, or prostate cancer.   "
207380|NCT00565240|"     We hypothesize that administration of an aromatase inhibitor (AI) and hormonal contraceptives     (HC) in the mid-luteal phase of the menstrual cycle will result in atresia of the follicles     in the extant wave and cause synchronous re-emergence of a new follicular wave. We anticipate     that this will provide us with information to facilitate the development of a new method for     ovarian synchronization; a safer, more effective ovulation induction therapy; a new method     for emergency contraception; and a greater understanding of human folliculogenesis.   "
207381|NCT00565253|"     The purpose of the study is to determine if inhaled nitric oxide, a potent and selective     pulmonary vasodilator, is beneficial in patients with acute pulmonary embolism causing     increased right ventricular afterload.   "
207382|NCT00565266|"     Typically, people with asthma are initially prescribed a low dose of inhaled corticosteroid     (ICS) medication to control asthma symptoms. If a low dose of ICS is ineffective at     controlling symptoms, the addition of a second controller medication is recommended. This     study will examine the effectiveness of the medication tiotropium bromide combined with a low     dose of ICS at maintaining asthma control in people with moderately severe asthma.   "
207383|NCT00565279|"     A growing body of evidence supports the hypothesis that the pathophysiology of seborrhoeic     dermatitis has a potentially causative neurogenic inflammatory aspect. ASF1057 is a new drug     that acts through a modulation of neurogenic inflammation through important complementary     mechanisms of action. This study will test the efficacy and safety of ASF1057 in the     treatment of patients with seborrhoeic dermatitis.   "
207384|NCT00565292|"     This is a study to assess the safety, efficacy, and tolerability of MK0859 in patients with     primary hypercholesterolemia (large amounts of cholesterol in the blood) or mixed     hyperlipidemia (high levels of LDL cholesterol, triglycerides, and low levels of HDL     cholesterol in blood) This is an early phase trial and some specific protocol information is     in progress and not publicly available at this time. (Full information is available to trial     participants).   "
207397|NCT00556959|"     The purpose of this study is to determine whether CLONICEL® (clonidine HCl sustained release)     is a safe and effective treatment for children and adolescents with attention deficit     hyperactivity disorder (ADHD).   "
207398|NCT00556972|"     The purpose of this feasibility study is to evaluate the performance and skin-friendliness of     the barrier of the Fecal Incontinence Management System. The investigator will complete a     questionnaire for each of the tested products and the products will be evaluated as regards     leakage, wear time, and skin-friendliness.   "
207399|NCT00556998|"     This study is designed to collect additional pharmacokinetic and safety data of voriconazole     in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help     establish voriconazole dosing recommendations for adolescents.   "
207400|NCT00557011|"     The purpose of this study is to assess, in a controlled environment, the efficacy and safety     of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.   "
207401|NCT00557024|"     The purpose of the investigators study is to prospectively evaluate whether radiotherapy as     an adjuvant therapy after RFA will improve the outcome of radiofrequency ablation for     hepatocellular carcinoma (HCC) or not.   "
207385|NCT00565305|"     The purpose of this research study is to understand effects of a complementary medicine     therapy, Healing Touch on quality of life and immunity of patients who are receiving     treatment for breast cancer. Healing Touch is a Holistic Therapy used as an adjunct to     medical treatment. The goal of Healing Touch is to restore energy and vitality to the body as     a patient is receiving treatment for cancer. Treatments include light touch on specific     points on the body as well as around the body, to increase well-being and support the body's     ability to heal. Healing Touch has been shown to increase relaxation and well-being and to     decrease anxiety, pain, and treatment side effects in a variety of illnesses including     cancer. Although Healing Touch is frequently used by cancer patients along with their medical     treatments, very little is understood about the effects of this treatment on the immune     system. The immune system is known to be important in the body's response to fighting cancer.     We are studying Healing Touch to help us understand whether or not these treatments are     effective in supporting the immune system during breast cancer treatment      Aim 1. To evaluate effects of a healing touch (HT) intervention on cellular immunity among     early stage breast cancer patients during radiotherapy.      Aim 2. To evaluate effects of a Healing Touch (HT) intervention on cytokines associated with     radiation damage and acute skin reactions in early stage breast cancer patients during     radiotherapy.      Aim 3. To evaluate the effects of a Healing Touch intervention on fatigue and mood in early     stage breast cancer patients during radiation treatment.   "
207386|NCT00565318|"     The purpose of this study is to investigate the effect of benfotiamine supplementation in     patients with diabetic nephropathy, and to determine whether it will slow down the     progression to end-stage renal disease (ESRD).   "
207387|NCT00565331|"     Our standard immunosuppressive treatment after renal transplantation is a combination of     tacrolimus, mycophenolate mofetil, and prednisolone. With this regimen the incidence of acute     rejection within the first six months after transplantation has dropped to about 20%. The     main challenge at present remains to improve long-term outcome by preventing chronic     allograft nephropathy (CAN). Since acute rejection is a strong predictor of CAN, a further     decrease in the incidence of acute rejection can improve the long-term graft survival.     Current strategies to prevent rejection are mainly directed at alloreactive T cells.     Recently, the attention for the role of antibodies in the pathogenesis of acute rejection has     increased. In addition, anti-B cell therapy was shown to be effective in diseases that were     considered to be mainly T cell driven, like rheumatoid arthritis. In the latter case it has     been suggested that anti-B cell antibodies may impair the antigen presenting function of B     cells. We therefore decided to investigate the effectiveness and safety of the anti-B cell     monoclonal antibody rituximab for prophylaxis of acute rejection after renal transplantation.      Study design: Double-blind, placebo controlled intervention study. One group receives a     single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation, and the     other group receives a placebo infusion.      Primary Objective:      To determine the incidence and severity of biopsy-confirmed acute rejection within the first     six months after transplantation.      Secondary Outcomes:        -  Renal function as estimated by the endogenous creatinine clearance at 6 months        -  Occurrence of chronic allograft nephropathy at 6 months        -  Cumulative incidence of infections and malignancies at 6 months        -  Medical costs during the first 6 months after transplantation        -  Patient and graft survival   "
207388|NCT00556816|"     COPD (chronic obstructive pulmonary disease) is a chronic disease which is increasing.     Patients with COPD are the most important concern of the pulmonologists. At the outpatient     clinic has been observed that the amount of new and regular COPD patients is of such a size     that it seems to overwhelm the capacity of the outpatient clinic. Solutions could be     substitution of medical care, longer intervals between the appointments or discharge from     secondary medical care to primary care. The first point does not solve the lack of capacity,     the second point is not allowed because it will decrease quality of care and transition of     care is a temporary solution. COPD is a complex disease, whereby, and certainly in an     advanced stadium, multidisciplinary and qualified expertise is needed.      The optimal control frequency of patients with COPD is unknown. COPD is a disease with     fluctuating activity and complaints over time. There is a chance that patients are seen at a     stable state at the regular outpatient clinical visits instead of moments when medical care     is obligated. The regular management of the outpatient clinic will therefore result in an     ineffective treatment of COPD patients. In this way general practitioners and even patients     could suggest that visits to the outpatient pulmonary clinic are confounding less to a good     treatment of COPD.      Outpatient clinical care on demand, initiated by patients in other chronic patient groups     like rheumatoid arthritis and inflammatory bowel diseases, are proven to be safe and     effective leading to less consumption and costs of medical care in comparison to standard     outpatient clinical visits 2-5.      The outpatient clinical care on demand for COPD is not figured out yet. Our aim is to     investigate whether this special type of outpatient clinical care is effective in the     management of COPD.   "
207389|NCT00556842|"     Each year, hip fracture, an injury that can impair independence and quality of life, occurs     in about 280,000 Americans and 36,000 Canadians. By the year 2040, the annual healthcare     costs associated with hip fractures are expected to reach $9.8 billion in the United States     and $650 million in Canada. It is important to have in place optimal practice guidelines for     the surgical handling of this injury. One type of hip fracture, called a displaced femoral     neck fracture, is often treated with a hip replacement surgery. Patients undergoing a hip     replacement may receive either a total hip replacement, in which the head of the femur and     the hip joint socket are replaced, or a partial hip replacement, in which only the head of     the femur is replaced. This study will compare the two different hip replacement procedures     to determine which one results in better outcomes after surgery in adults aged 50 and older.   "
207390|NCT00556855|"     The objective of this study is to evaluate the topical E-DO in patients with Chronic Hand     Dermatitis (fu kuei shou).   "
207391|NCT00556868|"     Breakfast is often labelled the most important meal of the day.      Parents and teachers quite often stress its importance for successful learning during the     morning hours. With declining numbers of children and especially adolescents eating breakfast     regularly, the study examines the influence of breakfast consumption on cognition and mood of     high school students.   "
207392|NCT00556894|"     This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory     agent, will improve the clinical condition of patients with rheumatoid arthritis who still     have active joint inflammation despite taking methotrexate for at least 6 months.   "
207429|NCT00557427|"     The study is a pilot study where adolescents 12 - 18 years of age with mild to moderate     depression will be randomized to receive either hypericum 250mg twice daily or fluoxetine     10mg daily increased to 20mg daily after 1 week and the option to increase to 40mg daily     after 4 weeks. Patients will be treated for a total of 8 weeks. Efficacy will be measured     using the CDRS-R, BDI-II and the CGI scales. Safety parameters include blood tests,     urinalysis and ECG.   "
207403|NCT00557050|"     A common soft tissue injury in sports involving sprinting and jumping is the hamstring     strain.      Not much evidence-based research has been carried out on prevention of hamstring strains.      Most studies suggest that hamstring strains occur during the later part of the swing phase     when the player is sprinting. In this phase the hamstring muscles are working to decelerate     knee extension - that is, the muscle develops tension while lengthening. This means that the     muscles change from functioning eccentrically to concentrically. We hypothesize that it is     during this rapid change from eccentric to concentric function that the muscles are most     vulnerable to injuries, and that the injuries can be prevented by increasing the eccentric     muscle strength in the hamstring.      This randomized clinical trial will examine the effect of a 10-week preseason     strength-training program in Danish elite soccer. The strength-training program focuses on     eccentric hamstring training.      60 elite teams (1200 soccer players) will be cluster-randomized to either ordinary training     or ordinary training combined with eccentric hamstring strength training. The training group     will start the training program in the pre-season (10 weeks) and continue the training once a     week during the following season.      Suspected hamstrings strains during the season will be examined within 3 days using     ultrasound. Ultrasound verified hamstring strains will be registered, and players will start     a standardized rehabilitation program.   "
207404|NCT00557076|"     The purpose of the study is to determine whether familiar vocal stimulation, provided during     coma recovery, improves outcomes for persons who are unconscious after severe TBI. The     primary hypothesis is that unconscious persons who receive standard rehabilitation (SR) plus     a high-dose of Familiar Voice stimulation (FVs) compared to unconscious persons who receive     SR plus a sham stimulation (Sham Group) will demonstrate:        1. Significantly more neurobehavioral functioning post-intervention compared to          pre-intervention.        2. Using Functional Magnetic Resonance Imaging (fMRI), significantly higher average          measures of volumetric activity in the whole brain, middle temporal gyrus bilaterally,          primary auditory area, bilateral pre-frontal cortex, hippocampus and/or the cerebellum          post-intervention compared to pre-intervention.   "
207405|NCT00557089|"     This study will assess whether rhDNase treatment improves ventilation inhomogeneity as     assessed by lung clearance index (LCI) in patients with cystic fibrosis (CF).   "
207406|NCT00557102|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving cetuximab     together with combination chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination     chemotherapy works as first-line therapy in treating patients with colorectal cancer that has     spread to the liver and/or lung.   "
207407|NCT00557115|"     The principal aim of the study is to evaluate whether attendance at an exercise training and     education programme (known as pulmonary rehabilitation) shortly following hospital discharge     can lead to a reduction in exacerbations and improvement in exercise capacity and quality of     life in patients with chronic obstructive pulmonary disease.   "
207408|NCT00557128|"     This is a randomized, open-label, single-dose, period-balanced, three-period crossover study     conducted in healthy subjects designed to evaluate whether the absorption of the FDC     formulation is affected by the ingestion of a high fat meal or is altered when taken in a     fasted state.   "
207409|NCT00557141|"     In a private practice setting typical for ambulatory medicine in Germany, asthma staging     according to the GINA guidelines will be correlated with real life treatment and self     management of adult outpatients suffering from asthma. Attitudes concerning adherence,     awareness, interest in shared decision making and knowledge about the disease are assessed.   "
207410|NCT00557154|"     The purpose of this study is to learn how the use of ultrasound helps with the placement of     an intravenous (i.v.) catheter in young children.   "
207411|NCT00557180|"     Asthma is a common, long-term disease that is caused by inflammation of the airways.     Inflammation also plays a role in obesity and may affect the way a person responds to asthma     medication. This study will examine the relationship between obesity and inflammation and the     effect they have on response to corticosteroid asthma medications.   "
207412|NCT00557193|"     This phase III trial studies combination chemotherapy with or without lestaurtinib with to     see how well they work in treating younger patients with newly diagnosed acute lymphoblastic     leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. It is not yet known whether combination chemotherapy is more     effective with or without lestaurtinib in treating acute lymphoblastic leukemia.   "
207413|NCT00557206|"     Patient receiving oxaliplatin and docetaxel will have longer progression free survival than     those patients receiving standard care.   "
207414|NCT00557219|"     The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney     function preservation in patients at high risk for renal failure after cardiac surgery.     Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery.     Some of them require renal replacement therapy and despite that mortality in this group     exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may     decrease the rate of severe renal failure.   "
207415|NCT00557232|"     Bevacizumab (Avastin®, Roche, Rio de Janeiro, Brazil) is an anti-VEGF recombinant humanized     monoclonal IgG1 antibody used to treat colorectal cancers. Bevacizumab may have a role in     treating ocular disorders involving fibrovascular proliferation. To determine whether     intraocular bevacizumab decreases rubeosis iridis in patients with neovascular glaucoma.   "
207416|NCT00557245|"     Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis     decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant     couples.   "
207430|NCT00557440|"     This study is designed to provide data about the 24 hours FEV1 profile, safety and     tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using     fluticasone/salmeterol as an active control.   "
207417|NCT00557258|"     The proposed study is a Cross-sectional epidemiological study, performed in 330 primary care     practices in Germany. The study will be conducted on a fixed day in November 2007.      Primary care surgeries throughout Germany will be asked to take part. The study material will     be delivered to the surgery by a member of sales-force who will also explain the study     conduct to the physician/staff. Physicians who want to take part in the study will send a     signed contract to BI. Physicians will be trained to diagnose RLS.      All patients attending the participating surgeries on a fixed day will be invited to     participate in the study. The patients will be handed a questionnaire to fill out while     waiting for their appointment. No patient-related data apart from gender and year of birth     will be recorded on the questionnaire and it will be ensured that no re-identification of     patients is possible. Therefore, no written informed consent will be obtained from the     participants.      The patient questionnaire will consist of the following items:      A screening questionnaire for RLS (according to Stiasny-Kolster et. al., data on file)     Additional questions concerning the impact of the patients leg problems on daily life.      The practice staff will then collect the questionnaire. All patients who have answered     question 1 (asking for unpleasant sensations of the legs) with ¿Yes¿ will subsequently be     assessed for the diagnosis by the physician.      The physician fills out a second questionnaire, covering the following items:      Diagnosis (cause of leg problems) Concomitant diagnoses and therapies If the diagnosis of RLS     was made: consequences (therapy)? Was the diagnosis of RLS pre-known? All completed     questionnaires will be sent to data management by the surgery within 2 working days.   "
207418|NCT00557284|"     AD is a disease found in children; the focus of the study is the mechanisms associated in     children with AD induced by food allergies.      This study will be a randomized, double-blind, placebo-controlled, parallel group trial     conducted in participants diagnosed with atopic dermatitis and food allergies. The study     duration for participants will be approximately 9 weeks. A total of 20 participants will be     recruited for the entire study. Each arm will consist of 10 participants.The study will     enroll 20 children, male or female, 1 - 8 years of age with atopic dermatitis (AD) associated     with food allergens, previously documented by skin or RAST test, before enrollment. Atopic     dermatitis and gastrointestinal (GI) symptoms will be scored and followed throughout the     study.   "
207419|NCT00557297|"     The aim of this non-interventional study is to ensure that patients in routine clinical     practice follow given treatment instructions and to evaluate the number of reliever     inhalations as well as the number of patient/days with more than 8/12 total inhalations at     any day. If the number of reliever inhalations and thus the received inhaled     glucocorticosteroid dose is not excessive, the safety conclusions from the clinical studies     can be extrapolated to real life for better acceptance of SMART (Symbicort Maintenance and     Reliever Therapy).   "
207420|NCT00557310|"     The purpose of this study is to use imaging technologies to demonstrate the effects of     teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women     with osteoporosis.   "
207421|NCT00557323|"     Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate     (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia,     including lanthanum carbonate (Fosrenol), for an additional 5 years. Patients were being     observed for any bone adverse events or other serious adverse events, as well as the     collection of mortality data.   "
207422|NCT00557336|"     This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height     gain during 12 months of growth hormone treatment in children born small for gestational age     due to intrauterine growth retardation.   "
207423|NCT00557349|"     This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or     Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer     after gastric bypass surgery.   "
207424|NCT00557362|"     We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal     keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study     to investigate the safety and feasibility of conducting a larger study and to generate     preliminary data.   "
207425|NCT00557375|"     Patients with recent diagnosis and treatment of a brain tumor will complete a short     questionnaire concerning the patient's quality of life and emotional state since receiving     treatment. Caregivers will complete a one-page questionnaire concerning the patient's quality     of life and emotional state since receiving treatment.   "
207426|NCT00557388|"     Aging is associated with the loss of lean muscle mass, termed sarcopenia. Food intake and in     particular the ingestion of protein or amino acids has been shown to be a powerful stimulus     to promote net muscle protein anabolism. However this anabolic response following a meal-like     protein bolus seems to be blunted in the elderly as compared to young adults.      The first aim of this proposal is to investigate the post-prandial muscle protein synthesis     rates in young and elderly men in response to a meal-like protein bolus after a period of     rest or physical activity (study A). The rest trial (REST) will act as a proof-of-principle     study to examine the blunted protein synthetic response in the elderly, and as a control     trial in comparison with the exercise trial (EXC) to establish the surplus value of physical     activity prior to protein intake on muscle protein synthesis.      The second aim of this proposal is to determine the surplus value of an increased quantity of     the ingested protein bolus (study B). Large amounts of protein (40 and 60 g) will be compared     to a meal-like amount of protein (20 g) as a means to maximize plasma amino acid availability     and/or to stimulate muscle protein anabolism.      The third aim of this proposal is to study the differences in quality of the ingested protein     bolus (study C). Instead of significantly increasing the quantity of the protein bolus, we     will also apply a more practical approach to augment skeletal muscle protein synthesis rates;     modifying the digestibility or amino acid composition of a meal-like protein bolus.   "
207427|NCT00557401|"     To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet     compared to placebo in subjects with symptomatic GERD   "
207428|NCT00557414|"     The purpose of this study is to determine the impact of the serum soluble triggering receptor     expressed on myeloid cells-1 (sTREM-1) on etiology and prognosis of acute respiratory     distress syndrome (ARDS)   "
207434|NCT00557505|"     P-cadherin may play a part in tumor growth; PF-03732010 is a new drug that inhibits     P-cadherin. This study will test how well the drug is tolerated, and what effects there might     be. Blood will also be taken to measure the amount of drug in blood.   "
207435|NCT00557518|"     Based upon the preclinical evidence in models of diabetic nephropathy under conditions     approximating both type I and II diabetes, treatment with alagebrium appears to have     favorable and advantageous effects on the biochemical, structural, pathological and     functional hallmarks of diabetic nephropathy. The renoprotective effects of alagebrium in     preclinical models favor the evaluation of this drug in patients with type I diabetes.   "
207436|NCT00557531|"     This is a Phase I, multi-center, open label study designed to assess the safety and     feasibility of the injectable BL-1040 implant to provide scaffolding to infarcted myocardial     tissue.   "
207437|NCT00557544|"     This is a Randomized double blind trial with the aim to estimate the effectiveness of 3     therapeutic regimes per os on migraine pain:        -  metoclopramide 0,15 mg/kg + placebo        -  metoclopramide 0,15 mg/Kg + ketoprofen 1 mg/kg        -  ketoprofen 1 mg/Kg + placebo      Intensity of pain will be measured with linear 1-10 scale or analogic McGrath type scale     every 20 min.      The main objective is the evaluation of healing times from pain in the 3 groups   "
207438|NCT00557557|"     The purpose of this study is to determine the maximum tolerated dose and dose limiting     toxicity of 5-FU in combination with Oxaliplatin delivered via isolated hepatic perfusion.   "
207439|NCT00557570|"     This study is designed to learn more about HIV infection and the conditions associated with     it.      Patients 18 years of age or older with known or suspected HIV infection may be eligible for     this study. Patients may have participated in previous NIH studies.      Participants will have periodic physical examinations and blood tests, including evaluations     for responses to treatment. Treatment consistent with accepted standard medical practice will     be individualized for each patient. Patients who previously participated in a NIH study will     be followed for possible long-term benefits or side effects of treatment. Patients treated     with alpha-interferon or interleukin-2 (IL-2) may continue treatment with that medication if     it is felt that they might benefit from it. Blood samples may be drawn as part of standard     medical care and for research purposes. Other tests may be done as appropriate for diagnosis     and treatment, including, for example, a chest X-ray, electrocardiogram, or tissue biopsy.     Patients will be seen for follow-up visits at regular intervals to monitor treatment     progress.      Certain patients currently enrolled in a NIH study of IL-2 treatment may participate in a     phase of the study that adds a corticosteroid, such as hydrocortisone, prednisone, or     prednisonolone, to the regimen. Patients whose CD4 counts did not increase with IL-2 will     receive corticosteroids (by mouth or by vein) in an open manner. Patients who responded to     IL-2 therapy will be randomly assigned to receive corticosteroids or a placebo (inactive     substance) during IL-2 infusions in a blinded manner, so that neither the patient nor the     medical staff will know which patients are receiving the drug and which are receiving a     placebo. Participants will be requested to receive at least three rounds of treatment with     corticosteroid or placebo.      Patients currently taking IL-2 by subcutaneous injection (under the skin) may participate in     an optional part of the study to receive future IL-2 cycles at home instead of at or near the     Clinical Center. Patients who have shown an ability to self-administer and tolerate IL-2     injections with minimal supervision and minimal side effects may be eligible for this option.     Home administration of IL-2 involves less frequent data and safety monitoring, and no on-site     medical evaluation at the very beginning of each cycle. Participants will continue to be seen     at the Clinical Center for regularly scheduled follow-up visits and medical evaluations     before the start of each IL-2 cycle to determine if it is safe to begin that cycle. Patients     will have a case manager who will place monitoring calls on days 2 and 4 of the cycle and a     third follow-up call 1 week later. Patients will be responsible for contacting a study staff     member if complications of other problems develop at other times.   "
207440|NCT00557583|"     The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy     subjects.   "
207441|NCT00557596|"     This is an open-label multicenter, phase 1-2 study. Following determination of the     recommended AEG35156 dose in combination with gemcitabine in the initial Phase 1 part of this     study, additional patients will be enrolled in the Phase 2 part of the study to assess the     activity of the combination first-line in advanced pancreatic cancer.   "
207442|NCT00557609|"     This is a multi-center, single arm intended to evaluate the anti-tumor effect of ARQ 197 in     patients with microphthalmia transcription factor associated (MiT) tumors. MiT tumors include     clear cell sarcoma, alveolar soft parts sarcoma, and translocation associated renal cell     carcinoma.   "
207443|NCT00557622|"     This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of     BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over     the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients     with posttraumatic stress disorder (PTSD) as assessed by the change from baseline in CAPS-SX     total score. Also the effect of paroxetine on regional cerebral blood flow (rCBF) induced by     subthreshold emotional arousing (or symptom stimulating) tasks will be determined using     functional magnetic resonance imaging (fMRI) for exploratory assessment of the correlation     between the change in rCBF and the efficacy.      The sample size is 30 subjects. The study period consists of 4 weeks of run-in phase, 12     weeks of treatment phase, 0-3 weeks of taper phase and follow-up examination at 2 weeks after     the last dose, for a total of 18-21 weeks.      Subjects will visit the clinic at the start of run-in phase, Week -2, the start of treatment     phase, Weeks 2, 4, 6, 8 and 12 of treatment, and follow-up examination.   "
207444|NCT00557635|"     Sometime osseous reconstruction needs allogeneic bone, in this study we use Ostéopure™ from     Ostéobanque d'Auvergne, which is a osseous matrix. However Ostéopure™ integration lasts a     long time. To optimize this integration we purpose to associate mesenchymal progenitors cells     from autologous bone marrow.   "
207445|NCT00557648|"     This study will evaluate the effectiveness of school-based cognitive behavioral therapy with     or without parental involvement in treating anxious children.   "
207446|NCT00557661|"     An open-label study designed to determine the safety, tolerability and pharmacodynamics of     CD-NP infusions in heart failure patients.   "
207447|NCT00557687|"     The purpose of this study is to evaluate if there is an association between the endocrine and     ultrasonographic markers of ovarian reserve and the IVF outcome and to determine which     markers contribute to the prediction of poor response in IVF.   "
207448|NCT00557700|"     This trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium     bromide versus placebo.   "
207449|NCT00557713|"     The purpose of this study is to determine the pathological complete response rate of addition     of bevacizumab to induction therapy (xelox) and concomitant treatment     (capecitabine+radiotherapy), followed by surgery.   "
207450|NCT00557726|"     This protocol is being established to cover the admission of patients with inflammatory     and/or infectious diseases which are not covered under previously existing protocols. The     purpose of such a protocol is that frequently patients are referred to us with either     diagnosed or undiagnosed illnesses which would be of interest to our teaching program or     which would serve as a source of patients to subsequently be entered into established,     ongoing protocol studies. Such patients will be admitted and handled according to accepted     medical practice of diagnosis and treatment.   "
208032|NCT00570986|"     The purpose of this study is to determine the safety and efficacy of 2 doses of ABT-874     versus placebo in the treatment of subjects with moderate to severe plaque psoriasis.   "
207451|NCT00557739|"     CRx-191 is a proprietary synergistic combination drug candidate being evaluated by     CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening     assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor-     alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of     psoriasis.      This clinical trial will assess the effectiveness of CRx-191 in reducing the psoriatic     infiltrate band thickness as measured by transdermal ultrasound. All subjects will receive     all treatments in separate test fields, with intra-individual comparison of the treatments.   "
207452|NCT00557752|"     -  Severe post-traumatic hypoxia is mainly due to lung contusion. The intubation rate of          these patients is near 20%.        -  Treatment before intubation is needed, is based on pain control with epidural anesthesia          and oxygen.        -  The investigators' hypothesis is that adding non-invasive mechanical ventilation to the          standard treatment can reduce the intubation rate if applied early in the course of the          disease.        -  As thoracic trauma is often associated with injuries in other body regions that may          increase the complications of the technique, specific contraindications have been          described.   "
207453|NCT00557765|"     After exposure to an active case of tuberculosis (TB), close contacts may be infected. They     are then considered as having latent tuberculosis infection (LTBI). Detecting LTBI is the     main goal of contact tracing procedures after exposure to TB. Until recently, the only test     available for detecting LTBI was the tuberculin skin test (TST). More recent tests are now     available (Interferon-gamma release assays: IGRA), which are more specific and sensitive than     the TST. This study compares the TST and an IGRA in the routine activity of contact tracing     in our area.   "
207454|NCT00557778|"     Evaluate the benefit (rate of adherence to the treatment), based on the LDL-C reduction in     the group that will be exposed to the program of reinforcement of orientation aimed to the     patients, compared to the control group, both in previous use of rosuvastatin.   "
207455|NCT00557791|"     The purpose of this study is to compare the safety and effectiveness of three doses of     intravitreal bevasiranib sodium as maintenance therapy for Age-Related Macular Degeneration     following initiation of anti-VEGF therapy with three doses of Lucentis®.   "
207456|NCT00557804|"     This is a multi-center, non-randomized study designed to develop an external monitor for CHF     patients.   "
207457|NCT00557817|"     Darbepoetin-alpha and i.v. iron administration after autologous hematopoietic stem cell     transplantation for hematological malignancies : a prospective randomized trial.   "
207458|NCT00557830|"     The primary objective of this study is to compare the effectiveness of a dose-escalation     regimen (400 to 800mg bid) relative to the standard dosing regimen (400mg bid) of sorafenib     given in patients with metastatic RCC.      The secondary objectives are to evaluate the effects of the dose-escalation regimen on the     quality of life (QoL) of patients with metastatic RCC and to characterize the safety and     tolerability profile of a dose-escalation regimen of sorafenib in patients with metastatic     RCC.   "
207459|NCT00557843|"     The primary objective is to evaluate the influence of continuous local anesthetic     infiltration on tissue oxygenation after surgical procedures requiring abdominal surgery as a     major predictor for wound healing.   "
207460|NCT00557856|"     The purpose of this study is to test the safety and effectiveness of PF-03446962 when given     as a single agent. Tumors require new blood vessels to support their ability to grow and to     spread (metastasize). New treatments aimed at preventing these blood vessels have the ability     to improve the clinical management of cancer.   "
207461|NCT00557869|"     The aim of the present study is the optimization of various magnetic resonance (MR)     investigation protocols of the heart and the lung without contrast agent application as well     as the generation of normal values from cardiac MR images. One of the main problems in     cardiac MR investigations is the strong dependence of the achieved image quality on optimal     settings of sequence parameters and anatomical and physiological situations with special     emphasis on phase-contrast imaging and other cine-techniques.   "
207462|NCT00557882|"     The primary aim of this double-blind, randomized clinical trial (RCT) is to test the     hypothesis that the addition of a standardized technique of interpositional synthetic     polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery     for anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.   "
207463|NCT00557895|"     This study will evaluate and follow patients with various allergic, hypersensitivity and     inflammatory disorders. The protocol is not designed to test new treatments; patients will be     managed with standard of care therapies. Participants may be referred to other current NIAID     protocols as appropriate or to new studies as they are developed, but will not be required to     join another study.      Patients with allergic, hypersensitivity or inflammatory disorders between the ages of 3     years and 80 years may be eligible for this study. Conditions of interest include, but are     not limited to, asthma, allergic rhinitis, mastocytosis, atopic dermatitis and food allergy.      Participants will have a medical history and physical examination, plus standard tests for     diagnosing and treating their specific disorder. Tests may include routine blood and urine     studies, X-rays or other imaging studies, allergy skin tests and lung function tests. Blood     samples may be collected for research on immune system cells and other substances involved in     immune function. Generally, about 2 to 6 tablespoons will be drawn at a time, but no more     than 16 ounces will be collected over a 6-week period.      NIH does not provide emergency medical treatment or treatment for other, unrelated conditions     the patient may have. Therefore, patients must maintain a personal physician for these     purposes.   "
207464|NCT00557908|"     The von Willebrand Disease Prophylaxis Network (VWD PN) is an international study group     formed with the goal of investigating the role of prophylaxis in clinically severe VWD that     is non-responsive to other treatment(s).   "
207477|NCT00558077|"     To date, it is still unclear the potential role of laparoscopic ovarian diathermy (LOD) in     the management of polycystic ovary syndrome (PCOS)-related anovulatory infertility. Metformin     administration, alone or combined with clomiphene citrate (CC), has shown to be an effective     and attractive second-line treatment for ovulation induction in women with polycystic ovary     syndrome (PCOS) after failure of CC treatment. The aim of the present study will be to     compare in a randomized controlled fashion the efficacy of LOD with metformin plus CC     administration in the treatment of the CC-resistant PCOS patients.   "
207465|NCT00557921|"     The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and     omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of     gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant     aspirin therapy.      Antiplatelet therapy is an essential element of care for patients with atherothrombotic     disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including     aspirin, clopidogrel and dual antiplatelet regimens.      The gastrointestinal tract is the most common site of bleeding related to antiplatelet     therapy, typically in connection with peptic ulcer disease. Recently published studies     suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of     aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of     these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher     risk of bleeding and ulcer disease.      Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product,     CGT-2168, which has the potential to significantly reduce this problem and increase patient     safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant     (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal     events.   "
207466|NCT00557934|"     Background: Residual pulmonary regurgitation following repair of tetralogy of Fallot, in     particular the use of a transannular patch, has been shown to correlate with the development     of right ventricular dysfunction. Optimal timing of pulmonary valve replacement, therefore,     is important to preserve right ventricular function. Several recent studies suggested that a     threshold of right ventricular end-diastolic volume for intervention, in order to preserve     the likelihood of adequate reverse remodeling, is in the region of 150 to 200 ml/m2 body     surface area. However, there is evidence that right ventricular function does not always     recover following pulmonary valve replacement even if the end-diastolic volume is below this     cut-off.      In addition, previous studies suggested that early dysfunction may be present before symptoms     occur. However, early dysfunction is difficult to assess.      Methods: Analysis of right ventricular function by pressure-volume loops has been extensively     evaluated in experimental studies and is generally considered the optimal way to quantify     right ventricular function.      By recording a family of pressure-volume loops during reduction of preload, achieved by     temporary balloon occlusion of the inferior caval vein, the contractility can be calculated     by the slope of the endsystolic pressure-volume relation (elastance). Changes of     contractility following dobutamine infusion could be noted by changes of elastance. The     increase of the slope during dobutamine demonstrates the contractility reserve of the right     ventricle.      Purpose: To evaluate the right ventricular contractility reserve to determine early     ventricular dysfunction after repair of tetralogy of Fallot.   "
207467|NCT00557947|"     This is a prospective, controlled, randomized, multi-center clinical study of up to 80     subjects with full thickness surgical incisions. Each incision included in the study will be     segmented into two halves; each half will be randomized to receive final skin closure with     either Prineo (DERMABOND PROTAPE) or intradermal sutures. Subjects will be evaluated     post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10     days).   "
207468|NCT00557960|"     Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on     simulated driving safety and performance of young adults with ADHD as measured by Driving     Safety Scores derived by the Driving Simulator.   "
207469|NCT00557973|"     The purpose of this study is to evaluate efficacy and safety of treatment with XP19986     Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal     cord injury   "
207470|NCT00557986|"     Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and     surgery is reserved for tumor related complications such as bleeding. Retrospective studies     showed that surgical removal of the primary tumor improves survival of patients with     metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the     primary tumor will lead to an improvement of overall survival   "
207471|NCT00557999|"     The following objectives were used for comparison: 1) primary objective: reintubation rate     during hospitalization; 2) secondary objectives: length of hospitalization at the Coronary     Care Unit; time from intubation to start of weaning; time from start of weaning to     extubation; time from SBT and extubation; presence of respiratory infection in patients     requiring reintubation; mortality of patients requiring reintubation.   "
207472|NCT00558012|"     This trial will examine the safety, efficacy and feasibility of a single dose of intravenous     zoledronic acid in the maintenance of skeletal integrity for frail, institutionalized women,     who are most at risk for the deleterious outcomes of osteoporosis. The investigators will     test the hypothesis that in institutionalized elderly women a single dose of intravenous     zoledronic acid therapy will: (1) be efficacious as demonstrated by stability or improvement     in bone mass measurements and reductions in bone turnover; (2) be safe and feasible; and (3)     provide estimates for vertebral and nonvertebral fracture reduction in this cohort for use in     planning a future study.   "
207473|NCT00558025|"     The objectives of this trial conducted in early Parkinson's disease (PD) patients are:        -  To assess if patients with early Parkinson's disease (PD) can be successfully switched          (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole          Extended Release (ER). A successful switch at a specific visit is defined as no          worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by          more than 15% from baseline and no drug-related adverse events leading to withdrawal;        -  To establish if this successful switch can be obtained with or without dose-adaptation;        -  To provide information about the conversion ratio (mg:mg) from Pramipexole IR to          Pramipexole ER.   "
207474|NCT00558038|"     The purpose of this study is to evaluate the safety and effectiveness of the experimental     drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.   "
207475|NCT00558051|"     The purpose of this study is to evaluate the administration, safety and immunologic     effectiveness of an experimental vaccine for colorectal cancer patients.   "
207476|NCT00558064|"     To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is     superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately     controlled with amlodipine 5 mg monotherapy.   "
217322|NCT00698854|"     The purpose of this prospective clinical data-collection is to document the performance and     clinical outcomes of the Vanguard™ Complete Knee System.   "
207479|NCT00558103|"     The double blind part of the study is being conducted to compare the efficacy and safety of     pazopanib in combination with lapatinib with that of lapatinib alone in subjects with     inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an     Open-label pazopanib arm to this study designed to test whether pazopanib given alone and     lapatinib given alone would be safe and effective to treat patients with inflammatory breast     cancer.   "
207480|NCT00558116|"     The Purpose of this study is to examine the effect of using the Carpal Tunnel Dynasplint®     System on patients diagnosed with CTS in a randomized, controlled, cross-over study.   "
207481|NCT00558129|"     To determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that     of conventional laminectomy in patients with lumbar spinal stenosis as measured by the Zurich     Claudication Questionnaire.   "
207482|NCT00558142|"     Millions of people receive radiographic contrast material for investigations like CT and     coronary angiography. While considered safe in healthy patients, it can cause acute renal     impairment. This is termed radiocontrast-induced nephropathy (RCIN) and is generally defined     as an increase in serum creatinine over baseline of more than 25% or 0.5 mg/dL (44.2 μmol/l)     within 48 hrs. RCIN occurs in less than 2% of patients with normal renal function but is more     common in patients with pre-existing renal damage.      The pathophysiology of RCIN is unclear. Possible mechanisms involve 1) reduced renal blood     flow leading to acute tubular necrosis and 2) direct renal tubular injury by oxygen free     radicals. Current prevention strategies focus on increasing renal blood flow and reducing     oxidative stress. Patients at risk of RCIN currently receive fluids, a low dose of contrast,     and variable and unproven doses of acetylcysteine.      The evidence for acetylcysteine administration is unclear. A RCIN consensus working group     reported in the American Journal of Cardiology in September 2006 that N-acetylcysteine is     not consistently effective in reducing the risk for contrast-induced nephropathy. The     perception of a benefit from acetylcysteine administration that is unproven has disadvantages     as some clinicians report giving larger amounts of radio-contrast to patients who have     received acetylcysteine since they believe that it prevents RCIN. There is a need to     determine how acetylcysteine might prevent RCIN and to identify the appropriate dose and     route of administration.      Since acetylcysteine is a vasodilator as well as an antioxidant, it may work in two distinct     ways, by preventing reduction in renal blood flow (RBF) or contrast-induced oxidative damage.     Previous studies have used changes in serum creatinine. In addition to being an insensitive     marker of altered renal function, if contrast causes renal vasoconstriction and     acetylcysteine vasodilatation, changes in serum creatinine will not be the ideal marker of     effect. Finally the optimum dose and route of acetylcysteine administration is unclear, as     illustrated by studies using a variety of doses and routes.      We propose to study the mechanism of effects of acetylcysteine on healthy and diseased     kidneys, both unstressed and stressed by radiocontrast administration. We hypothesise that     acetylcysteine may exert a renoprotective effect in RCIN by a renal vasodilatation and/or     antioxidant mechanism.   "
207483|NCT00558155|"     The aim of the study was to assess the clinical effect of immunostimulatory enteral and     parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205     subjects were randomly assigned into four study groups, standard and immunostimulating,     enteral and parenteral. The study was designed to test the hypothesis that immunonutrition     and enteral nutrition would reduce the incidence of infectious complications following upper     gastrointestinal surgery.   "
207484|NCT00558168|"     Collecting information regarding adverse events from patients on treatment with anastrazole     with early stage breast cancer   "
207485|NCT00558181|"     Studies have shown that both high-dose Methylprednisolone and Rituximab used as single agents     are effective in relapsed and refractory B-CLL. Methylprednisolone acts independently of p53     apoptosis pathway. The combination of both drugs may improve response and outcome in     previously treated high-risk B-CLL patients.      Study Objectives      Primary:      To determine the clinical benefit of high-dose Methylprednisolone and Rituximab in previously     treated high-risk B-CLL patients in terms of clinical and flowcytometric response rate.      Secondary:      To determine progression free and overall survival. To characterize the safety profile of     high-dose Methylprednisolone and Rituximab.   "
207486|NCT00558194|"     Behavioral weight loss, the current treatment of choice for moderate obesity, achieves     impressive short term results, however, weight regain following treatment is a major problem.     Over 50% of participants in behavioral weight loss programs report difficulty with internal     antecedents to unhealthy weight control behaviors and this difficulty is associated with     weight regain following treatment. Current treatment approaches do not adequately address     these antecedents. The aim of this series of studies is to develop, implement, and evaluate a     behavioral weight loss program modified to provide participants with skills to deal     effectively with affective and cognitive difficulties. The study targets men and women with     BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to     unhealthy weight control behaviors. The study will randomize 120 participants to receive 12     months of standard behavioral therapy for weight loss or standard behavioral treatment plus     affective and cognitive skills training. The long-term goal of this research is to improve     the weight loss maintenance outcomes of behavioral weight loss programs by addressing     affective and cognitive antecedents to unhealthy weight control behaviors.   "
207487|NCT00558207|"     This is a multi-center, open-label randomized phase 2 study designed to assess the     progression free survival (PFS) of patients with untreatment and unresectable pancreatic     cancer following treatment with either ARQ 197 or gemcitabine. The study will also evaluate     other efficacy and safety endpoints including overall response rate, overall survival and     adverse events in the two treatment arms.   "
207488|NCT00558220|"     The purpose of this study is to show if addition of Rituximab to intensive induction     (MegaCHOP/ESHAP) and high-dose consolidation (BEAM) improves progression-free and overall     survival in patients younger than 65 years with aggressive B-cell lymphoma and aaIPI 2 or 3.   "
207489|NCT00558233|"     The purpose of this study is to determine whether a multimedia educational computer program     can increase colorectal cancer screening rates in low and adequate literacy patients.   "
207490|NCT00558246|"     This is a prospective, controlled, randomized, multi-center clinical study of up to 80     patients with full thickness surgical incisions associated with bi-lateral breast procedures.     Breast procedures where symmetrical incisions of at least 15cm in length are planned for both     breast (bilateral procedure) will be randomised to receive final skin closure of one breast     with Prineo (DERMABOND PROTAPE) and the other with intradermal sutures (control). Patients     will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days,     and 90 days (± 10 days).   "
207491|NCT00558259|"     The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to     placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in     patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed     6 to 18 months of treatment with vitamin K antagonist (VKA).   "
207492|NCT00558272|"     The purpose of this study is to determine the effect of AZD0530 on subjects with breast     cancer or prostate cancer with metastatic bone disease in comparison to zoledronic acid.   "
207495|NCT00558311|"     The aim of this study is to demonstrate that clazosentan, administered as a continuous     intravenous infusion at 5 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH),     reduces the incidence of cerebral vasospasm -related morbidity and all-cause mortality within     6 weeks post-aSAH treated by surgical clipping. The primary endpoint of the study is the     occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6     weeks post-aSAH, defined by at least one of the following:        1. Death (all causes).        2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant          contributing cause, or not adjudicated to be entirely due to causes other than          vasospasm.        3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the          primary or relevant contributing cause, or not adjudicated to be entirely due to causes          other than vasospasm.        4. Neurological signs or symptoms (depending on state of consciousness), in the presence of          confirmed cerebral vasospasm on angiography (DSA or CTA), leading to the administration          of a valid rescue therapy.      An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet     the primary endpoint and its individual morbidity components.   "
207496|NCT00558324|"     Determine the flap thickness created by femtosecond laser or a mechanical microkeratome using     in vivo confocal microscopy and compare measured versus intended flap thickness.   "
207497|NCT00558337|"     Determine if a novel levodopa/carbidopa formulation results in a better clinical response on     Parkinson's Disease patients compared to the reference formulation of levodopa/carbidopa in     terms of motor complications, onset of action and response duration.   "
207498|NCT00558350|"     Inflammatory reaction in different compartments of the body may have a negative effect on     outcome. This study assesses the inflammatory reaction systemically, intrapulmonary and     intrapleural by measuring different cytokines. Patients with lung cancer undergoing lobectomy     or segmentectomy are included in the study. Hypothesis: The inflammatory reaction in the     pleural space is high compared to the systemic and intrapulmonary ones.   "
207499|NCT00558363|"     ARI109924 will be a 2-year, multicentre, randomised, double-blind, placebo-controlled trial     assessing the efficacy and safety of dutasteride in extending time to prostate specific     antigen (PSA) doubling in men who have been treated for clinically localised prostate cancer     (PCa) with a radical therapy (radical prostatectomy, primary radiotherapy or salvage     radiotherapy) with curative intent but who experience a biochemical failure (PSA rise)     afterwards without signs or symptoms of metastases.   "
207500|NCT00558376|"     The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium     phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation     with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is     advantage for substituting the purgative used, as compared to repeating the colonoscopy with     the same purgative.Briefly, patients whose preparation was inadequate, will be allocated     randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive     sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days.     Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced     endoscopist.   "
207501|NCT00558402|"     The goal is to determine how 6-week stress reduction techniques may decrease stress in     primary caregivers of people with Alzheimer's disease. The 3 intervention programs are     meditation, education, and respite care. There will be approximately 108 subjects over 3     years. Subjects will have a screening session over the phone to see if they are eligible     (50-85 years old, spending at least 12 hours per week caring for a close relative with     Alzheimer's disease, willing to be in any of the 3 groups, and without any very serious     medical problem). The subjects will have 3 testing sessions, 1 before classes/respite and 2     after classes are over, each lasting about 3 hours. The classes are taught in a one-on-one     setting, and they are 50 minutes per week for 6 weeks. Respite care is provided for the     person with Alzheimer's disease in all the groups. Measurements include people's ratings of     stress, psychological testing, and biological measurements of stress, including the     following: saliva, blood, and urine collection; waist-to-hip ratio; weight; blood pressure;     heart rate; respiration; reaction time task; voice recordings; electrocardiogram;     electroencephalogram; and electro dermal activity.   "
207502|NCT00558428|"     The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination     T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight     weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the     fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks     compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose     combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to     A10 in patients who fail to respond adequately to six weeks treatment with A5.   "
207503|NCT00558441|"     The study purpose is to prospectively collect data for a set of predefined variables in     clinical cases where coronary plaque lipid characterization by IVMRI was performed during     diagnostic or interventional procedures in order to gather incremental information beyond     angiography and other diagnostic modalities.   "
207504|NCT00558454|"     Iron is essential for brain development and there is a well established association between     iron deficiency in infants and poor neurological development. In Sweden, about 5% of newborns     have low birth weight (< 2500 g). Due to small iron stores at birth and rapid postnatal     growth, they have increased risk of iron deficiency and it is therefore important to prevent     iron deficiency in this population. However, excessive iron supplementation can have adverse     effects in infants such as growth impairment. In a randomized, controlled trial, we are     investigating the effects of 0, 1 or 2 mg/kg/d of iron on brain myelination, cognitive     development and growth in low birth weight infants.   "
207505|NCT00558467|"     A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and     safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with     Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the     Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks.   "
207520|NCT00558675|"     The purpose of this study is to determine the safety and anti-tumor effects of an     experimental immunotherapy drug, called AlloStim, which is intentionally mis-matched immune     cells which are designed to elicit the same anti-tumor mechanism that occurs in allogeneic     bone marrow/stem cell mini-transplant (BMT) procedures, without the toxicity associated with     graft vs. host disease (GVHD).   "
207506|NCT00558480|"     In populations with high prevalence of latent tuberculosis infection (LTBI), malnutrition     (PEM) may influence incident rates of TB. PEM and specific micronutrient deficiencies     compromise cell mediated immunity (CMI) and increase susceptibility to, or severity of     infections. Vitamin A supplementation significantly reduces all-cause child mortality. The     mechanism of the benefits of supplementation on clinical outcomes is largely unknown, but is     likely to be related to an influence on the immune system. Vitamin A supplementation promotes     lymphogenesis and induces a higher proportion of CD4 naïve T-cells in children. Most cases of     LTBI that progress to active disease are vitamin A deficient. Vitamin A deficiency is common     in most TB endemic countries. At the MRC, 32% of TBCC contacts were vitamin A deficient.      Hypothesis:      The investigators plan to test the hypotheses: that supplementation with vitamin A will     affect the magnitude and quality of immune responses to mycobacterial antigens and     progression to clinical disease.   "
207507|NCT00558493|"     A multi-center and open study to compare the safety and effectiveness of switching treatment     from lamivudine to clevudine for 24 weeks.   "
207508|NCT00558506|"     This is an open-label trial investigating the efficacy and safety of abatacept in ankylosing     spondylitis. It is planned to treat 30 patients with ankylosing spondylitis from baseline up     to week 30. Abatacept will be administered intravenously according to the prescription used     in rheumatoid arthritis.   "
207509|NCT00558519|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating     young patients with newly diagnosed acute lymphoblastic leukemia.   "
207510|NCT00558532|"     The purpose of this study is to determine the concentration of omega-3 fatty acids in plasma,     blood and abdominal fat before and after bariatric surgery to provide guidance for future     studies.   "
207511|NCT00558545|"     This is an open-label multicenter, phase 1-2 study. Following determination of the     recommended AEG35156 dose in combination with weekly paclitaxel in the initial Phase 1 part     of this study, additional patients will be enrolled in the Phase 2 part of the study to     assess the activity of the combination in advanced breast cancer.   "
207512|NCT00558558|"     Primary:        -  To determine if treatment with Haelan (fermented soy product) can decrease the severity          of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best,          100 mm = worst) at week 4 +/- 5 days.        -  To determine if treatment with Haelan can decrease the severity of nausea, fatigue, and          improve patients' overall sense of well being measured using a VAS of 0 to 100 mm (0 mm          = best, 100 mm = worst) at week 4 +/- 5 days.        -  To determine if treatment with Haelan can increase patient's calorie intake, albumin,          pre-albumin, anthropometric measure, lean body mass (measured by bio-impedence          analysis), and weight at week 4+/- 5 days.        -  To determine if treatment with Haelan can decrease patient's Functional assessment of          anorexia/cachexia therapy subscales or (FAACT) and the Functional Assessment of Chronic          Illness Therapy with fatigue subscales (FACIT-F) at week 4+/- 5 days.        -  To assess the feasibility of accrual, and adherence to the Haelan consumption.      Secondary:        -  Determine the plasma isoflavone activity, 12-MTA and 13-MTA of these patients.        -  Correlate the biologic modulation of peripheral blood lymphocyte NF-kB by Haelan with          primary outcome in these patients.        -  To determine if treatment with Haelan can increase patient's functional status at week          4+/- 5 days.   "
207513|NCT00558571|"     Primary objective: safety and tolerability of BI 10773 in male and female patients with type     2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773   "
207514|NCT00558584|"     The purpose of this study is to investigate the effects of immunoadsorption and subsequent     IgG substitution in patients with dilated cardiomyopathy compared to a control group.   "
207515|NCT00558597|"     In patients with acute rejection after lung transplantation the peptide profile in     broncho-alveolar lavage (BAL) and urine should be compared in order to identify a paradigm     that allows an non-invasive rejection therapy.   "
207516|NCT00558623|"     Lead accumulates in bone. During pregnancy, physiologic changes occur prompting bone     resorption in order to provide calcium to the growing fetal skeleton also release the lead     stored in bone into a pregnant woman's circulation. We have previously demonstrated that lead     stores mobilized into the circulation of pregnant women pose a major threat to fetal     development. This is particularly unfortunate since bone lead stores, once accumulated,     persist for decades, thereby jeopardizing the pregnancies of women even if their current lead     exposures have subsided. What then can be done for the many thousands of women who have had     lead exposure while growing up and who want to have healthy children? To address this     question, in 2000, this project embarked on a randomized intervention trial to test whether a     bedtime nutritional supplement of 1,000 mg of calcium can significantly reduce fetal lead     exposure and toxicity by suppressing bone resorption in the pregnant mother.   "
207517|NCT00558636|"     The purpose of this study conducted in Asia-Pacific was to evaluate the efficacy and safety     of Sorafenib in combination with paclitaxel and carboplatin versus placebo in combination     with paclitaxel and carboplatin for chemonaive patients with unresectable stage IIIB (with     effusion) or stage IV NSCLC. However, as indicated below, the study was terminated     prematurely when the results from Study 11961 (NCT00300885), an earlier Phase 3 study of     similar design in subjects with advanced NSCLC, showed an overall lack of efficacy and     increased mortality in subjects with squamous subtype. The data available is presented as     descriptive analyses, due to the limitations of implementing the statistical analysis plan.   "
207518|NCT00558649|"     The purpose of this study is to determine whether low dose flu vaccines delivered with     microneedles into the skin (intradermally) are effective.   "
207519|NCT00558662|"     The study purpose is to compare healing rates, cost effectiveness, quality of life and safety     of 12 week compression therapy for the treatment of venous leg ulcers with the 3M™ Coban™ 2     Layer Compression System versus short-stretch compression bandage.   "
207521|NCT00558688|"     The purpose of this study is to compare the efficacy of photodynamic therapy with     5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.   "
249368|NCT01120067|"     This study is investigating the efficacy of an intensive (3 week) integrated treatment for     Veterans with both pain and PTSD.   "
207523|NCT00558727|"     This is a Phase 1, nonrandomized, open-label, dose-escalation study of 3-hour IV infusions of     RH-1 administered to patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL).      Treatment will continue until a patient meets criteria for discontinuation.   "
207524|NCT00558740|"     Individuals submitted to a high-fat or a high-fructose/sucrose diet develop, over a 6     day-period, several features of the metabolic syndrome, including increased plasma     triglycerides, increased intrahepatic lipids, and decreased hepatic insulin sensitivity. It     has been recently observed that the increase in intrahepatic lipids observed after a high fat     diet is largely prevented when protein intake is concomitantly increased. This suggests that     dietary protein protects the liver against some of the deleterious effects of a high fat     diet. Mechanisms underlying this effect of protein may include an increased hepatic fat     oxidation.      The aims of this study are:        1. to evaluate the effects of dietary protein on several major pathways involved in hepatic          lipid metabolism ( ketogenesis, lipid oxidation, de novo lipogenesis, VLDL-triglyceride          secretion        2. to determine whether the decrease in intra-hepatic lipids observed when dietary protein          intake is increased are to be attributed to acute or long-term effects of proteins   "
207525|NCT00558753|"     The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin     given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the     prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The     prevalence of complex regional pain syndrome (CRPS) following total knee arthroplasty (TKA)     is 13% at 6 months post-surgery. CRPS is a painful debilitating condition, with 4 main     classes of symptoms : sensory, including burning, allodynia, and hyperalgesia in the affected     limb; vasomotor, including temperature asymmetry and skin color changes; edema and sudomotor,     including sweating; and movement disorders and dystrophy, including decreased range of     motion, motor dysfunction (weakness, tremor, dystonia) and changes in hair, nails or skin.   "
207526|NCT00558766|"     Background:      The brain releases signals to mark rewards for certain behavior. Some medications for     Parkinson disease (PD) can cause some patients to engage in compulsive behavior, possibly     because the medications affect this reward system.      By using transcranial magnetic stimulation (TMS), researchers can study brain activity when     an individual receives a reward.      Objectives:      To learn how the brains of people with PD behave when rewarded.      To learn whether two common Parkinson medications (levodopa and pramipexole) change this     behavior.      To compare reward signals in the brains of healthy volunteers with reward signals in the     brains of people with PD.      Eligibility:      Women between 50 and 80 years of age and men between 45 and 80 years of age.      Participants will be divided into healthy volunteers and volunteers who have mild to moderate     PD.      Design:      Prescreening will consist of a neurological examination and a series of questions about     gambling habits and drug and alcohol use.      Participation in a TMS study involving a computer game simulation of a slot machine:        -  Before the simulation, participants will receive TMS to establish a baseline response          rate.        -  During the simulation, participants will play a game in which they will receive real          money.      TMS will be administered to each patient under three different conditions:        -  TMS administered when patients have not taken any Parkinson medication.        -  TMS administered after patients have taken levodopa.        -  TMS administered after patients have taken pramipexole....   "
207527|NCT00558779|"     The purpose of the study is to compare two surgical strategies for coronary artery bypass     grafting with respect to the occurrence of cerebral infarctions made visible by magnetic     resonance imaging   "
207528|NCT00558792|"     Determine the validity and compare the visualization of arterial segments obtained with 3     doses of iopamidol to determine dose for further investigation in future trials.   "
207529|NCT00558805|"     This project evaluates a brief intervention in the emergency department (ED) for adolescents     presenting with suicide attempts. The intervention aims to capitalize on the opportunity     offered by the ED visit to deliver an effective intervention, improve adherence to follow-up     care, decrease the risk of repeat suicide attempts, and improve clinical and functioning     outcomes.   "
207530|NCT00558818|"     A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is     to investigate safety and efficacy of clevudine in patients chronically infected with     hepatitis B virus, HBeAg positive or negative.   "
207531|NCT00558831|"     The purpose of this study is to compare the efficacy of a benzoyl peroxide 2.5% cream     formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for the     treatment of acne vulgaris.   "
207532|NCT00558844|"     This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg     of Arikace™ versus placebo in patients who have Cystic fibrosis.   "
207533|NCT00558857|"     This is a prospective, non-randomized study to determine the feasibility of using a new     technique called Dynamic Substrate Mapping (DSM) to help guide the treatment of ischemic     ventricular tachycardia (IVT). We hypothesize that DSM will lead to simpler, more effective     ablation of IVT. Results from this study will be used to determine if further clinical     investigation is warranted.   "
207534|NCT00558870|"     Objectives:      Primary Objective:      To determine whether the addition of low dose methadone to morphine(in the methadone group)     has a lower dose escalation index as compared to the morphine alone(in the morphine group) at     Day 15 (+/- 3 days)      Secondary Objectives:      To determine whether individuals on the methadone arm have lower pain intensity than the     morphine alone arm as demonstrated by a decrease in two points from baseline (+/- 3 days) in     their ESAS score at Day 15 (+/- 3 days).      To determine whether the methadone group of experiences fewer opioid induced neurotoxic side     effects (including sedation, myoclonus, hallucinations, hyperalgesia and confusion) as     compared to the morphine alone group at Day 15 (+/- 3 days).   "
207550|NCT00559091|"     The purpose of this study is to determine if ribavirin (a drug commonly used to treat     hepatitis C) also has activity in the treatment of patients with refractory or relapsed acute     myeloid leukemia (AML) of the M4 and M5 subtype.   "
207565|NCT00559286|"     The hypothesis of the presented study is: Telmisartan induces an increase of eNOS activity in     RBC resulting in an enhanced intravascular NO bioavailability, an ameliorated RBC     deformability and a reduction of RBC and platelet aggregation. This could be a potential     mechanism of the improvement of microcirculatory disorders, especially in patients with     diabetes mellitus and arterial hypertension, treated with Telmisartan.   "
207535|NCT00558883|"     Acarbose an alphaglucosidase inhibitor changes in a complex way the transport, the digestion     and the place of glucose release and absorption. As a result the intestinal milieu, the     intestinal flora and the provision of enzymes in the lower small destine are changed. This     should modify immune response of intestinal wall on food and its proinflammatory effects. The     small intestine is the biggest immune organ of the organism. The postprandial glucose     increase could have a direct effect on low-grade inflammation. Toxic effects (glucotoxicity),     activation of the immune system and low grad inflammation could be reasons of developing     endothelial dysfunction and affect plaque stability. The activity of the lymphocyte immune     system in the intestine would be a further component, by which acarbose could take influence     on diabetogenesis and atherogenesis. The question of an enterovasal axis is one of the new     research concepts. As indicators of this axis considered: leucocytes, high sensitive     C-reactive protein, plasminogen activator inhibitor antigen and lymphocytes sub-populations.     The effect of acarbose on these parameters in the postprandial phase are not known yet.   "
207536|NCT00558896|"     RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in     different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the     growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with     dexamethasone may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone     works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.   "
207537|NCT00558909|"     The primary objective of the current study is to investigate the safety and tolerability of     BI 44847 in male and female patients with type 2 diabetes following oral administration of     repeated doses of 100 mg b.i.d, 400 mg b.i.d. and 800 mg b.i.d. over 28 days.      A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI     44847 after multiple dosing, including assessment of steady state.   "
207538|NCT00558922|"     This is an open-label multicenter, phase 1-2 study. Following determination of the     recommended AEG35156 dose in combination with carboplatin and paclitaxel in the initial Phase     1 part of this study, additional patients will be enrolled in the Phase 2 part of the study     to assess the activity of the combination in advanced non small cell lung cancer.   "
207539|NCT00558935|"     The purpose of this study is to investigate the effects of red wine on ABCA1 levels   "
207540|NCT00558948|"     The purpose of the study is to evaluate bone mineral density and muscle strength in survivors     of bone marrow transplant. Association with age, type of transplant, steroids, years since     transplant, body composition, endocrinopathies, radiation, quality of life and physical     activity will be explored.   "
207541|NCT00558961|"     The purpose of this study is to determine maximum tolerated dose of Gleevec in combination     with Chlorambucil in previously treated CLL patients.   "
207542|NCT00558987|"     The purpose of this study is to test the effectiveness of a video-based parent education     intervention delivered in the primary care setting on parents and other caregivers discipline     attitudes and practices.   "
207543|NCT00559000|"     The purpose of the study is to assess the effectiveness of KIDNET in treating traumatized     refugee children in Germany   "
207544|NCT00559013|"     Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement     to minimize the risk of leakage during or after colo-rectal surgery.   "
207545|NCT00559026|"     This phase I/II study is directed at evaluating safety and immunogenicity of a melanoma     peptide vaccine in combination or not with Dacarbazine administration in melanoma patients   "
207546|NCT00559039|"     RATIONALE: Gathering information about pregnancy, infancy, and early childhood exposures may     help doctors identify cancer risk factors, and may help the study of cancer.      PURPOSE: This natural history study is looking at the effects of fetal, infant, and early     childhood exposures on adult cancer risk in women.   "
207547|NCT00559052|"     EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as     chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI.     The current treatment of EPI includes enzyme supplementation with porcine pancreatic enzyme     concentrate, consisting mainly of lipase, amylase and protease. An enzyme preparation able to     deliver appropriate enzyme levels to the duodenum instead of the mid gut or distal small     bowel, would appear to be clinically efficacious for the treatment of steatorrhea in subjects     with CP suffering from EPI.   "
207548|NCT00559065|"     This study will examine the risks of workplace exposure to benzene, a substance known to lead     to cancer of the blood and possibly of the lungs. It is used widely in industries and is a     contaminant in the environment. Researchers from the National Cancer Institute and the China     Center for Disease Control (formerly Chinese Academy of Preventive Medicine) had done     previous studies of workers in manufacturing industries in China of people who worked at     least 1 day from 1972 to 1987 in 12 cities in that country. Data were collected of     approximately 75,000 workers exposed to benzene and 35,000 who were not, with the purpose of     investigating the relationship between benzene exposure and cancer risk. For workers exposed     to benzene, there was a significant risk of cancer affecting the blood cells and a 1.8-fold     excess of lung cancer among them. This study will expand those findings and also identify the     effects of benzene amounts and whether there is a genetic tendency for benzene poisoning.     About 3,860 benzene-exposed workers from the 12 cities will be interviewed. Next-of-kin of     deceased workers, and a subcohort (additional grouping) of participants will serve as a     control group in the research.      Patients who have worked at places where there was exposure to benzene will have a brief     physical exam and samples of cells from a mouth rinse and samples from blood will be     collected to study the genetic influence on developing blood diseases from workplace     exposures.      All participants or next-of-kin, for deceased, will be given a questionnaire about their work     history, use of cigarettes and hair dyes, medications they take, and family history of     cancer. Interviews of about 40 minutes long will be conducted at participants homes or     workplaces, at a time convenient to them, and the interviews will be audiotaped.   "
207549|NCT00559078|"     This qualitative interview-based study will investigate the impact that living with     congenital adrenal hyperplasia has for women in the following areas: health-related quality     of life (HRQL), psychological health, and health-seeking behaviors.   "
217897|NCT00703677|"     The goal of this trial is to evaluate the safety and tolerability of lithium in people with     progressive supranuclear palsy or corticobasal degeneration.   "
207551|NCT00559104|"     RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous     peripheral stem cell transplant stops the growth of cancer cells by stopping them from     dividing or killing them. The patient's stem cells are then returned to the patient to     replace the blood-forming cells that were destroyed by the chemotherapy and radiation     therapy.      PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy     together with or without total-body irradiation followed by a stem cell transplant and to see     how well it works in treating patients with non-Hodgkin lymphoma.   "
207552|NCT00559117|"     Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in     Patients with Advanced Metastatic Cancer   "
207553|NCT00559130|"     The hypothesis of this study is use of CytoSorb hemoperfusion device as an adjunctive therapy     to the standard of care in treating ARDS/ALI patients in the setting of sepsis will result in     improved clearance of cytokines when compared to control patients receiving only the standard     of care.   "
207554|NCT00559143|"     Aim of present study is to examine the short and long-term results of pacing from right     ventricular apex and to compare them with those of biventricular pacing.   "
207555|NCT00559156|"     RATIONALE: Giving a nutritional supplement containing arginine, omega-3 fatty acids, and     nucleotides to patients undergoing chemotherapy and radiation therapy may stimulate the     immune system and help the body build a stronger immune response.      PURPOSE: This phase II trial is studying how well an arginine/omega-3 fatty acids/nucleotides     nutritional supplement works in treating patients with stage III or stage IV head and neck     cancer undergoing chemotherapy and radiation therapy.   "
207556|NCT00559169|"     One in 3 epilepsy patients have refractory seizures. This drug resistance is likely related     to the over expression of multidrug resistance proteins (MDR). Progesterone is a known     inhibitor of MDRs and the low level of this hormone during the menstrual cycle may exacerbate     seizures, perhaps explaining catamenial epilepsy; i.e. seizures occurring during the     menstrual cycle. Verapamil suppresses seizures in animal models of epilepsy perhaps by     inhibiting MDRs and thus may help patients with refractory seizures. If the study shows     improved seizure control, the results will help establish the role of MDRs in refractory     epilepsy.   "
207557|NCT00559182|"     This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II     Dose (RP2D), pharmacodynamic, and clinical activity of MK-8033.      Parts A and B of the study will determine the maximum tolerated dose (MTD) and RP2D. Part C     of the study will be a single panel crossover study to determine the effect of omeprazole, a     gastric pH modifier, on the pharmacokinetics of MK-8033.   "
207558|NCT00559195|"     RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve     fatigue in patients with malignant solid tumors receiving palliative care.      PURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and     anemia in patients receiving palliative care for malignant solid tumors.   "
207559|NCT00559208|"     The purpose of this study is to assess the cost-effectiveness of this Differential Wraparound     model, in 5 Children's Aid Societies within Hamilton-Niagara Region, in preventing     maltreatment cases from either becoming ongoing protection cases, or the children ending up     in out-of-home of out-of community placements, as well as reducing the amount of time in     Children's Aid Society care as compared to usual Children's Aid Society risk assessment and     protection service alone.   "
207560|NCT00559221|"     - To determine the feasibility of fludarabine and cytarabine as continuous infusion plus     idarubicin with granulocyte-colony stimulating factor priming for patients with resistant     acute myeloid leukemia other than acute promyelocytic leukemia   "
207561|NCT00559234|"     This study will evaluate potential candidates for future clinical research studies related to     diagnosed or undiagnosed genetic eye disorders or diseases. It will not test any new     treatments, but it may arrange for standard treatments for existing eye disorders. The     purpose of the study is to train eye doctors and medical researchers at the National     Institutes of Health in appropriate methods and procedures for treating patients with genetic     eye diseases, and to expand the pool of possible participants for future research studies and     trials on eye health.      Volunteers for this study may be adults and minor children who have been diagnosed with or     are at risk for having a genetic eye disease. Candidates may not have any other medical     conditions that would interfere with the researchers' ability to perform the examinations and     procedures required for this study.      Participants will give a complete medical and family history and undergo a series of tests     and procedures as part of this research study. The procedures include a full eye examination     and vision testing, electrooculography and an electroretinogram to examine the function of     the retina, and flourescein angiography to provide information on the flow of blood in the     participant's eyes. Participants will provide research material for further studies by giving     a blood sample to be held for genetic testing and analysis, and adult participants will also     undergo a skin biopsy to provide cell tissue for additional research material. At each clinic     visit, participants will receive treatment for their genetic eye disease as needed, including     medications or surgical procedures. Participants may remain a part of this study for up to     three years.   "
207562|NCT00559247|"     The primary purpose of this study is to evaluate the safety profile and tolerability of     single oral doses of BMS-650032 in subjects with chronic hepatitis C infection   "
207563|NCT00559260|"     This is a 300 subject prospective study to assess cardiorespiratory events associated with     current practice sedation (150 subjects; opioid + benzodiazepine) versus anesthesia provider     sedation (150 subjects; propofol) for upper and/or lower endoscopy.   "
207564|NCT00559273|"     This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous     darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who     are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants     will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2     micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45     mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is     3-12 months.   "
207566|NCT00559299|"     The purpose of this study is to determine the safety and tolerability of a new drug,     GSK163090, which is being developed for the treatment of depression and anxiety disorders.   "
207567|NCT00559312|"     Even patients with milder COPD can have significant physiological abnormalities which become     more pronounced during exercise, leading to intolerable breathing discomfort (dyspnea). While     there is a compelling physiological rationale for the efficacy of inhaled     corticosteroid/long-acting bronchodilator combination therapy [i.e., fluticasone     250μg/salmeterol 50μg (FSC250/50)] in moderate to severe COPD, little information is     available on the potential impact of this therapy in milder symptomatic disease. This study     will be the first to explore mechanisms of dyspnea and activity limitation in milder COPD and     will determine if there is a sound physiological rationale for the use of FSC as therapy for     this subpopulation.   "
207568|NCT00559338|"     The purpose of this study is to determine if an 8hr infusion of nesiritide in the emergency     department in the Acutely decompensated heart failure patients will decrease 30 day     recidivism.   "
207569|NCT00559351|"     The purpose of the study was to test a null hypothesis that a combined modality treatment of     esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery     alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant     treatment of esophageal cancer.   "
207570|NCT00559364|"     This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea     (malabsorption of dietary fats) in patients with a history of exocrine pancreatic     insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. This study is     sponsored by Aptalis Pharma (formerly Axcan).   "
207571|NCT00559377|"     This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and     fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment     for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Diagnostic     procedures using positron emission tomography (PET scan), fluoromisonidazole F 18, and     fludeoxyglucose F 18 to find oxygen in tumor cells may help doctors predict how patients will     respond to treatment.   "
207572|NCT00559390|"     In this study, we want to find out more about polycystic ovary syndrome(PCOS). This is a     common problem in about 7% of teenage girls. Problems may include irregular periods, extra     hair on the face, chest and back areas. It seems that PCOS is related to a high level of male     hormones and to another problem called metabolic syndrome(MBS). People with MBS may have high     blood pressure, low good cholesterol, high blood fats and extra fat around the waist. Girls     with MBS are at high risk for getting diabetes and heart disease.   "
207573|NCT00559403|"     This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual     behavior of South African adolescents.   "
207574|NCT00559416|"     Some HIV-infected individuals have a white blood cell marker known as HLA-B*57 that appears     to help control the progress of the disease; however, not all who have the HLA-B*57 marker     are able to control the infection. This study will examine the effects of giving white blood     cells with HLA-B*57 from an individual who controls HIV infection to an individual who cannot     control HIV infection, as a form of HIV treatment. All candidates will be screened with a     medical history, physical examination, and blood and urine tests.      Both donor and recipient volunteers must be HIV-positive individuals 18 years of age or older     who have the HLA-B*57 marker and are receiving care. Donor candidates must have positive HIV     antibody tests for at least seven years with a recent CD4 cell count greater than 400     cells/mm?, HIV viral load less than 50 copies/mL, and no previous HIV viral load greater than     1,000 copies/mL. Recipient candidates must have positive HIV antibody tests with a recent CD4     cell count less than 400 cells/mm? and HIV viral load greater than 10,000 copies/mL, and must     have failed at least two prior combination antiretroviral regimes and are willing to receive     or resume combination antiretroviral therapy. Donor volunteers will be excluded if they have     taken certain antiretrovirals drugs, have a medical history of cancer or of other blood-borne     illnesses, or have other medical conditions that might interfere with the study. Recipient     volunteers will be excluded if they have a medical history of malignant cancer or other     medical conditions that might possibly interfere with the study.      Donors will undergo apheresis to separate white blood cells from circulating blood before the     red blood cells and plasma are returned to the bloodstream. The procedure will take up to     five hours, and donors will be required to return for additional tests. Donors may be asked     to return for further white blood cell donations, a maximum of six procedures per year.      Recipients will undergo apheresis to obtain stem cells for possible use in the study, and     will be admitted to an NIH Clinical Center inpatient unit to receive an infusion of white     blood cells and undergo a series of blood tests both before and after the infusion. The     infusion process will take two hours. After being discharged, recipients will be asked to     return to the Clinical Center for monitoring and follow-up tests, and may receive further     infusions....   "
207575|NCT00559429|"     The primary objective of the study is to determine a recommended phase II dose (RP2D).      The secondary objective of the study are:        1. To evaluate preliminary incidence and duration of clinical benefits as determined by          improvements of pain, PSA decline and bone scan changes.        2. To evaluate the toxicity profile of the escalating doses of Docetaxel in combination          with Samarium 153 in patients with advanced, hormone refractory prostate cancer          metastatic to the bone.   "
207576|NCT00559442|"     It has been shown, that subjects susceptible to high altitude pulmonary edema (HAPE)are     characterized by an abnormal increase of pulmonary artery pressure at rest in hypoxia and     during exercise in normoxia. This abnormal rise of pulmonary artery pressure has also been     observed in about 10 % of otherwise healthy subjects without prior altitude exposure. The aim     of the study is to investigate the susceptibility to HAPE in unacclimatized subjects with     abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in     normoxia after rapid ascent to high altitude (4559 m).   "
207577|NCT00559455|"     Primary objective:      To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with     the combination chemotherapy of Eloxatin+5-FU/LV      Secondary objective:      To evaluate time to progression, 6month survival, overall survival, safety and tolerability     of patients with hepatocellular carcinoma treated with the combination chemotherapy of     Eloxatin+5-FU/LV   "
207578|NCT00565344|"     We will obtain data from the robust Agency for Healthcare Reimbursement and Quality (AHRQ)     Healthcare Utilization Project (HCUP), as well as from the State of Tennessee. If our     hypotheses are true, such data will provide strong evidence that Medicaid disenrollment has a     negetive health impact on uninsured populations. The data may also provide evidence for     increased public funding of safety-net EDs after Medicaid disenrollment.   "
207579|NCT00565357|"     The purpose of this study was to determine the effects of individual noise reduction using     silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and     development. The study hypothesis was that newborns who were randomized to the earplug group     would be heavier than controls at 34 weeks post-menstrual age.   "
207580|NCT00565370|"     There is strong scientific rationale for exploring the role of sorafenib with capecitabine     and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel     signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through     blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine     kinases VEGF-R2 and PDGFR-beta.   "
208239|NCT00574691|"     To assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to     facilitate hemostasis in patients undergoing diagnostic or interventional procedures.   "
207581|NCT00565383|"     We aim to answer the clinical question: Does combined spinal-epidural analgesia improve the     success rate of external cephalic version? We hypothesize that neuraxial analgesia (spinal or     epidural analgesia) during version for breech presentation increases successful fetal     rotation and decreases the incidence of Cesarean delivery for malpresentation.   "
207582|NCT00565396|"     The purpose of this study is to determine whether fosinopril and losartan are effective in     the treatment of patients with Chronic Kidney Disease(CKD) stage 3.   "
207583|NCT00565409|"     To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate     with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.   "
207584|NCT00565422|"     The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and     effective in treating problematic internet use.   "
207585|NCT00565435|"     Since Chiari malformation is a common disease, many patients require surgical operation to     relieve pressure from the back portion of the skull. The purpose of this research is to     compare two different materials that are routinely used to repair the opening in the brain     covering during the surgery on the back portion of the skull in patients with symptomatic     Chiari Malformation. None of the materials used in this study nor any procedures are     experimental.   "
207586|NCT00565448|"     The primary objective is to estimate the Complete Response rate of docetaxel to the     combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in     the Induction treatment of Nasopharyngeal Carcinoma (NPC).      The secondary objectives are to determine:        -  the safety of TCF in comparison to CF after induction treatment of NPC,        -  the pharmacokinetics of docetaxel when added to CF,        -  the Overall Response rate of TCF and CF on completion of induction and consolidation          (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and          CF.   "
207587|NCT00565461|"     To evaluate the immune responses achieved following self-administered heat-labile enterotoxin     of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses     achieved by clinician-administered vaccination.   "
207588|NCT00565474|"     Principal objective is to investigate if the treatment with fluvastatin can prevent the     progression of vascular graft disease in de novo renal transplant patients.   "
207589|NCT00565487|"     The primary purpose of this study is to determine the best dosage of Capecitabine and Tarceva     combination in the setting of radiation and to assess treatment effectiveness,     progression-free survival and overall survival.   "
207590|NCT00565500|"     Study design: Single center, placebo-controlled, double blind, parallel groups. To evaluate     the potential interaction between aspirin and ibuprofen or celecoxib in patients with     osteoarthritis (OA) and documented stable ischemic heart disease, a total of 24 patients     chronically treated with aspirin will be randomly assigned to one of the 3 treatment groups:     1) celecoxib 200 mg bid; 2) ibuprofen 600 mg tid; 3) placebo.   "
207591|NCT00565513|"     We studied prospectively the incidence of cryptorchidism in Nice area. We tightly matched     each affected child (n=95) with 2 healthy controls (n=188) and assessed risk factors for     cryptorchidism focussing on prenatal exposure (cord blood and maternal milk) to endocrine     disruptors known to affect testis migration, searching for correlations with cryptorchid     status   "
207592|NCT00565526|"     Background:      Sj(SqrRoot)(Delta)gren s Syndrome (SS) is an autoimmune disease that affects the glands that     produce saliva and tears, causing dry eyes and dry mouth.      Researchers do not know the exact cause of SS, but they believe that it may be caused by     abnormalities in the autonomic nervous system (ANS) that stimulate these glands.      Objectives:      To better understand ANS function in patients with SS.      To compare information about ANS function in healthy individuals and in patients with SS.      Eligibility:      Patients with Sj(SqrRoot)(Delta)gren s Syndrome who are 18 years of age and older, and who     are not pregnant or breastfeeding.      Participants will be asked to taper or discontinue the use of certain medications or dietary     supplements before the ANS testing.      Participants must be willing to discontinue the use of alcohol and tobacco 24 hours prior to     testing.      Design:      The study will require one inpatient admission and/or outpatient visits to the NIH Clinical     Center.      The following tests and procedures will be performed:        -  Saliva, tear, and sweat production measurements to evaluate the function of glands.        -  Testing of changes to the cardiovascular system, including blood pressure and blood flow          testing, and an electrocardiogram designed to evaluate hemodynamic changes controlled by          the ANS.        -  Testing of changes to the gastrointestinal system, including a swallowing assessment          study, barium swallow study, and gastric emptying study designed to evaluate          gastrointestinal function controlled by the ANS.        -  Tests to evaluate the ANS function in response to certain drugs (edrophonium, glucagon          and acetylcholine).        -  Self-reported questionnaire on ANS function and emotional/psychological well-being.      Additional procedures and tests may include the following:        -  Blood samples.        -  Optional skin biopsy to study sweat glands and nerve supply of the skin.   "
207593|NCT00565539|"     Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral     infections. The purpose of this study is to test the safety and antiviral effects of     PEG-rIL-29 (a man-made form of IL-29) when it is given either by itself at different doses or     in combination with the approved dose of ribavirin (an antiviral drug) to subjects with     hepatitis C infection who have received no prior treatment for this disease or who have     relapsed following previous treatment with PEGylated interferon alpha (PEG-IFN-α), or other     form of IFN-α, and ribavirin.   "
207594|NCT00565552|"     So far the evaluation of scar treatment was based on subjective criteria. The patient groups     were divided into treated versus non-treated.      In this study we use patients undergoing ear reconstruction with autologous rib cartilage.     The thoracic scar of harvesting the rib cartilage is routinely reopened after 3 month during     second stage of reconstruction. Therefore we have a ideal model of clinical, physiological     and histological scar evaluation in a homologous patient group.      All patients randomly treat one half of the scar with a silicone gel (Dermatix). The other     half is untreated as an internal control.   "
207595|NCT00565565|"     This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552     in a single dose escalation design. Furthermore, this study examines the changes in     hemodynamics after application of the test substance.42 hospitalized stable patients with     chronic heart failure will be included. Several measurements will be performed to test how     good the drug works and wether there are any unwanted reactions to the drug (e.g. blood     tests, ECG, heart rate, blood pressure, adverse events). After a observation period the     patient will be discharged from the hospital.   "
207596|NCT00565591|"     This open label single blind study will determine the safety of albuterol sulfate dry powder     in a novel inhaler by observing for the potential occurrence of reflex bronchial constriction     after inhalation of increasing doses of the compound.   "
217898|NCT00703690|"     This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the     effects of MK0767 on triglycerides.   "
207597|NCT00565604|"     This trial is designed as a prospective, non randomized, single center clinical trial to     determine the safety and efficacy of laser ablation of incompetent perforator veins.      Within this clinical evaluation, fifty (50) limbs will be treated with Vari-Lase ®. A duplex     ultrasound will verify the presence or absence of incompetent perforator veins (IPV). In     addition, the number, diameter and location of the IPVs will be determined. Limbs with IPVs     which measure greater than or equal to 3mm in diameter and are located superior to the foot     and distal ankle will be considered for entry into the study.   "
207598|NCT00565617|"     Objective: Chronic epidural cortical stimulation (ECS) involves the neurosurgical placement     of an electric wire on the surface of the brain with intermittent activation. Over time, ECS     modulates local and distal connected brain regions. It is being currently applied over the     motor cortex to treat intractable pain. Because of the important role played by the medial     prefrontal cortex in mood regulation, the goal of this study is to apply this minimally     invasive neurostimulation modality over medial prefrontal cortex in severely ill depressed     subjects who have failed all other attempts at treatment.   "
207599|NCT00565630|"     The purpose of the study is to confirm that Vigamox reaches similar aqueous concentration     when administered as the commercially available eye drops or as a spray delivered from a     proprietary device.   "
207600|NCT00565643|"     A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of     Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary     outcome will be measurement of the extent and severity of adhesions at the time of subsequent     cesarean delivery. Secondary outcomes will include measures of safety, operative times (ex.,     incision-delivery; total operative time).   "
207601|NCT00565656|"     The objectives of this phase II trial are to test the efficacy and tolerance of Bevacizumab     in MDS patients with excess of marrow blasts and to evaluate the impact of Bevacizumab on     angiogenesis and erythropoiesis.      To limit the myelotoxicity observed in the preliminary phase II study, Bevacizumab will be     administrated at the initial dose of 5 mg/kg.      The primary endpoint will be response: Complete Remission (CR), Partial Remission (PR) and     hematological improvement (HI) according to IWG criteria (see appendix 3).      The secondary endpoints will be survival, response duration, side effects, evaluation of     angiogenesis (bone marrow microvessel density, VEGF plasma level, VEGF mRNA expression,     HIF-1alpha expression).      The design of this study consists of three study periods: pre-treatment (screening),     treatment (loading and maintenance), and follow-up. All patients will participate in the     study for at least 12 weeks of therapy, a 4-week follow-up visit, and long-term follow-up     unless the criteria for planned or unplanned early discontinuation are met.   "
207602|NCT00565669|"     The purpose of this study is to evaluate the efficacy of Blink Tears and Systane used     concomitantly with topical cyclosporine for the treatment of dry eye.   "
207603|NCT00565682|"     To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the     already known effect when administered after such a procedure. Patient will be receiving     either etoricoxib or the respective placebo one hour before surgery, then two hours after     those receiving the active will receive placebo and those that received placebo will be given     etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be     available all the time.   "
207604|NCT00565994|"     We hope to study components within the blood that may predict success, failure or other     associated complications in relation to the type of vascular access being used.   "
207605|NCT00566007|"     The purpose of this study is to assess the efficacy (vs. placebo) of ozone infiltration and     its effectiveness in comparison with micro discectomy in the treatment of lumbar herniated     disc with criteria for surgery.   "
207606|NCT00566020|"     This study is planned to assess the long-term safety of lamotrigine in Japanese patients with     bipolar I disorder who will continue into the 52-week extension upon completion of a     double-blind comparative study (Study No.: SCA104779 (NCT00550407)), i.e. the patients who     receive the addition of any additional treatment to intervene in a mood episode in the     double-blind phase or the patients completing the double-blind phase.   "
207607|NCT00566033|"     Test whether the intensive intervention improves renal and cardiovascular outcomes in     patients with chronic renal insufficiency.      Test whether a multi-method intensive intervention including clinical Audit improves     adherence to a series of quality indicators relevant to hypertension control, proteinuria,     treatment of dyslipidemia, anemia, calcium and phosphate alterations in patients with chronic     renal insufficiency.   "
207608|NCT00566046|"     Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two     types of seizures are usually identified: early seizures during the week following the trauma     and late epilepsy afterward. Several antiepileptic drugs are usually used to prevent early     seizures but no treatment has demonstrated any preventive effect against late epilepsy.     Levetiracetam is an antiepileptic drug usually used for the treatment of epileptic patients     and has pharmacologic properties that could also be interesting for the prevention of     post-traumatic epilepsy.   "
207609|NCT00566059|"     Patients planned for elective conventional coronary angiography will undergo CT coronary     angiography (Dual Source CT) in order to assess the correlation of stenosis detection and     therapeutic advice between conventional and CT coronary angiography. We hypothesize that     their is a good correlation between conventional and CT coronary angiography for stenosis     detection and therapeutic advice.   "
207610|NCT00566072|"     21 patients were randomised to receive instructions and coaching or no intervention on the     use and intake of ganciclovir. Intake of medication was measured by an electronic pill box.     The duration of the study was 100 days.   "
207611|NCT00566085|"     Molecular Breast Imaging is a highly promising novel methodology for breast cancer detection.     Preliminary patient studies with our dual-detector system indicate that this system is     capable of reliably detecting very small (5-10 mm) malignant lesions in the breast. Besides     the usefulness of Molecular Breast Imaging for tumor detection, we speculate that tumor     uptake and washout may be predictors to response to neoadjuvant therapy for patients with the     diagnosis of breast cancer. We propose that in patients with breast cancer who undergo     neoadjuvant chemotherapy or neoadjuvant hormone therapy that molecular breast imaging is an     accurate test for assessing response rate to neoadjuvant therapy.   "
207612|NCT00566098|"     RATIONALE: Activating white blood cells in the laboratory may help them kill more cancer     cells when they are put back in the body. This may be an effective treatment for patients     undergoing a stem cell transplant for multiple myeloma.      PURPOSE: This phase I/II trial is studying the side effects of activated white blood cells     and to see how well they work in treating patients who are undergoing a stem cell transplant     for newly diagnosed stage II or stage III multiple myeloma.   "
207613|NCT00566111|"     We aim to study the efficacy of intravenous ceftriaxone in a four-week, inpatient,     placebo-controlled, double-blind study, as an augmentation therapy in patients with bipolar     disorder, currently depressed, who have failed to respond to conventional treatments.   "
207614|NCT00566124|"     To purpose of this study is to compare the pharmacodynamic properties of insulin detemir,     insulin glargine and NPH insulin after a single subcutaneous injection.   "
207615|NCT00566137|"     To determine sleep disturbance, pulmonary function test, 6 minute walk, echocardiogram     abnormality, arterial blood gas, ventilation/perfusion scan of the chest in Scleroderma     patient with Pulmonary Hypertension.   "
207616|NCT00566150|"     A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the     effects of levetiracetam on depressive symptoms in bipolar depressed patients.   "
207617|NCT00566176|"     RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar     System for PV Isolation on a beating heart for the treatment of all types of atrial     fibrillation in a sole therapy operation (not concomitant to another cardiac operation).   "
207618|NCT00566189|"     Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80%     (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases.     The current consensus supports bariatric surgical treatment for diabetic patients with BMI as     low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the     surgery as well.      This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI     30-35) human volunteers on incretins, insulin production and sensitivity and its clinical     (diabetic chronic complications) and metabolic impact.   "
207619|NCT00566202|"     The purpose of this study is to evaluate the safety and effectiveness of JNJ-18038683     compared to escitalopram and placebo in patients with moderate to severe depression.   "
207620|NCT00566215|"     Based in a surgery technique studied in a non-obese diabetic mouse model by Rubino and     Marescaux(2004), wich reversed diabetes in those animals, we have performed a previous study     in human volunteers with type 2 diabetes and overweight (non-obese). The surgery is a     duodenal exclusion in wich the stomach volume is kept intact. We observed improvement of     glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn     or significantly lowered.      Further improvement of diabetes could be achieved by intervention in insulin resistance,     another factor of diabetes pathophysiology. As that factor is related to visceral fat, we     hypothesize that surgical removal of the major omentum, a great component of central     adiposity, could beneficial .      This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after     duodenal exclusion surgery plus total omentectomy, by the method of standardized meal     stimulus and insulin tolerance test, in human non-obese volunteers with diabetes type 2 and     known insulin secretion capacity.      The previously studied volunteers submitted to duodenal exclusion without omentectomy will be     the control group.   "
207621|NCT00566228|"     RATIONALE: It is not yet known which method of stem cell collection is best for patients     undergoing an autologous stem cell transplant.      PURPOSE: This randomized phase III trial is comparing two different methods of collecting     stem cells in patients undergoing stem cell transplant for diffuse large cell lymphoma.   "
207622|NCT00566241|"     28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and     composition in adults with cystic fibrosis.   "
207623|NCT00566254|"     The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.   "
207624|NCT00566267|"     People who follow a low-carbohydrate diet typically experience a decrease in triglycerides     and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients     may require lipid-lowering therapy. Statins may not be the most effective strategy for     patients on this diet, since they typically consume a greater amount of saturated fat and     cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We     hypothesize that patients following a low carbohydrate diet would experience a significantly     greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in     the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg     alone.   "
207625|NCT00566280|"     The purpose of this study is to evaluate molecular breast imaging in the workup of patients     with a history of bloody nipple discharge, not reproducible in the office who have a negative     clinical breast examination, and a negative diagnostic mammogram and breast ultrasound.   "
207626|NCT00566306|"     The aim of this study is to 1) test the efficacy of PHMG-based disinfectant against C.     difficile spores, 2) test whether it reduces the incidence of C. difficile associated disease     (CDAD) and 3) evaluate cost.   "
207627|NCT00566319|"     This study is a three-armed randomised controlled trial that aims to determine the effect of     a structured educational programme on physical activity levels and glucose tolerance in     individuals with impaired glucose tolerance (IGT). The educational programme is designed to     promote physical activity by targeting perceptions and knowledge of IGT, exercise     self-efficacy, and self-regulatory skills. The study will also investigate whether the     effectiveness of the educational programme at promoting self-regulatory skills and physical     activity is enhanced by the inclusion of a pedometer and personalised step/day goals.   "
207635|NCT00566423|"     The investigators hypothesize that baseline plasma brain natriuretic peptide (BNP) and     migration inhibitory factor (MIF) levels are surrogate markers of clinical severity of PAH     and that changes in plasma brain natriuretic peptide (BNP) and MIF levels pre and post     exercise.   "
207636|NCT00566436|"     The objective of this study is to compare remote superficial femoral artery endarterectomy     with suprageniculate bypass surgery in the treatment of long occlusions of the superficial     femoral artery. The study hypothesis is that patency rates are comparable and therefore the     minimal invasive remote superficial femoral artery endarterectomy can be considered in     patients presenting with a long occlusion of the superficial femoral artery.   "
207628|NCT00566332|"     Waldenström's macroglobulinaemia (WM) is a lymphoproliferative disorder characterized by a     monoclonal IgM paraprotein and morphological evidence of lymphoplasmacytic lymphoma: the     cells are IgM+, IgD+, CD19+ and CD20+ but usually CD5-, CD10- and CD23-. The treatment     efficacy is difficult to assess because of the lack of clear diagnostic criteria , good     response criteria, and of randomized trials.      The actual treatment is Chlorambucil, an alkylating agent. A purine analogue such as     Fludarabine has proven its efficacy on 30 % to 80 % as first line therapy      This study is a phase II b open, prospective, international multicenter trial (England, Dr     Johnson, Dr Catovsky, Australia: Dr Seymour) promoted by the French Cooperative Group on     Chronic Lymphoid Leukemia in untreated WM, or closely related disorders ( Lymphoplasmacytic     lymphoma or splenic marginal zone lymphoma). 366 patients must be included, among them 180     patients in France. Patients will be stratified according to the lymphoproliferative     disorder.      The patients will receive Chlorambucil by oral route for 10 days every 28 days (12 cycles) (8     MG/M², 6 MG/M² if patient is more than 75 years old) or Fludarabine by oral route for 5 days     every 28 days (6 cycles) (40MG/M², 30 MG/M² if patient is more than 75 years old).      The primary objective is to compare the efficacy (response rate) of Chlorambucil to     Fludarabine in previously untreated patients. The secondary objectives are the duration of     response, the improvement of hematological parameters, the toxicity, the quality of life, the     event free survival and the overall survival.   "
207629|NCT00566345|"     The primary purpose of this study is to demonstrate the efficacy of an investigational     Vero-cell derived influenza vaccine to prevent infection in an adult population with an     influenza virus that is antigenically similar to one of the three strains in the vaccine. All     subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of     three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will     be monitored for 180 days following vaccination for occurrence of adverse events. For     determining antibody response, subjects will have one blood draw before and one blood draw 21     days after vaccination.   "
207630|NCT00566358|"     Diabetes reversion is observed after bariatric surgeries even before significant weight loss     could explain it, mainly in predominantly malabsorptive procedures (98,9% for biliopancreatic     diversion or duodenal switch), followed by those combining malabsorption and gastric     restriction (83,7% for Roux-en-Y gastric bypass). Changes in the hormonal communication     between the digestive system and the pancreas would explain the antidiabetogenic role of the     surgery, so this effect could be obtained in nonobese, diabetic individuals.      In order to try this hypothesis, RUBINO and MARESCAUX (2004) studied the gastrojejunal bypass     (duodenal exclusion)in an mouse model of diabetes without obesity. In their technique the     stomach volume is kept intact, maintaining the caloric ingestion and the weight of the     animals. There was a fast improvement of diabetes, independent of diet and weight, without     the potential nutritional deprivations commonly seen in the bariatric surgery like iron and     vitamin deficiency.      This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after     duodenal exclusion surgery in human non-obese, diabetic volunteers and known insulin     secretion capacity, by the method of standardized meal stimulus. It is expected to be     secondary to changes in the gastrointestinal hormones that stimulate insulin secretion     (incretins).      The knowledge about the clinical outcomes of this technique in humans and the description of     the secretion pattern of gastrointestinal hormones after the surgery may contribute to the     implementation of this surgery as a new therapeutic option for overweight (non-obese)     diabetic patients.   "
207631|NCT00566371|"     This study is a single site, double-blind, randomized, placebo-controlled parallel group     design. this study is designed to directly examine the efficacy of a single daily dose of     atomoxetine taken in the morning in alleviating sleep initiation insomnia in children with     ADHD. Primary outcome measures are sleep parameters, specifically mean sleep onset latency     (time of onset to persistent sleep), as measured by actigraphy/sleep diary, and parent and     child-reported evening settling difficulties, as measured on the evening subscale items of     the parent and child versions of the DPREMB-R. Secondary outcome measures include: additional     actigraphic sleep parameters (night wakings, sleep duration, and sleep efficiency), daytime     sleepiness (Pediatric Daytime Sleepiness Scale, sleepiness visual analogue scale (VAS), and     morning behaviors on the DPREMB-R); ADHD symptom improvement (ADHD-RS, parent version;     provider-completed CGI); a neurocognitive measure of attention and impulsivity (CPT);     executive functions (Brown ADD Scale for Children) and functional outcomes/quality of life     (CHQ).   "
207632|NCT00566384|"     The purpose of the study is to evaluate the effectiveness of the study drug on the libido     (sexual desire) of women who are taking oral contraceptives and who have experienced libido     reductions as a side-effect of this contraceptive method The hypothesis is that there is     superiority in the change in sexual desire and arousal component scores of the FSFI     questionnaire from baseline to cycle 6 of the treatment with the study drug as compared to     Placebo.   "
207633|NCT00566397|"     The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in     participants with mild to moderate Alzheimer's disease.   "
207634|NCT00566410|"     Dichloroacetate (DCA) is a small molecule that has been used for years to treat lactic     acidosis and rare metabolic disorders in humans. Further testing now shows that it may     suppress the growth of human cancer cells. Tests of DCA on human cells cultured outside of     the body found that it killed lung, breast, and brain cancer cells, without affecting human     normal cells. Tumors in rats that were infected with human tumors also shrank considerably.     Most cancers are characterized by a resistance to apoptosis (cell death that removes abnormal     cells) that makes them more likely to grow as well as be resistant to most cancer treatments.     Plus, many current cancer treatments kill both cancerous and healthy cells and are highly     toxic. DCA works by reversing the damage to the mitochondria that is present in cancer cells,     thus reactivating the apoptosis (cell death) mechanism in them. The result is the death of     the cancer cells. This mitochondrial reactivation presents an entirely new approach to     treating cancer.      DCA is known to be relatively well tolerated with few significant side effects and its     selectivity, effectiveness and ease of delivery (oral) make it an attractive opportunity. It     is hoped that one day this treatment may become a safe and effective treatment, either along     or in conjunction with other treatments, for many forms of cancer.   "
207637|NCT00566449|"     The purpose of this study is to evaluate the safety and effectiveness of JNJ-31001074     compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD).   "
207639|NCT00566475|"     The purpose of this study is to determine if using school-based telemedicine for diabetes     support and education in students with type 1 diabetes in grades K-8 can lead to improvement     in control of diabetes and improved satisfaction of all caregivers.   "
207640|NCT00566488|"     This study has three primary purposes: to assess parathyroid function after parathyroid     transplantation in infants with Complete DiGeorge syndrome; to assess immune function     development after transplantation; and, to assess safety and tolerability of the procedures.     This is a Phase 1, single site, open, non-randomized clinical protocol. Enrollment is closed     and study intervention is complete for all enrolled subjects; but subjects continue for     observation and follow-up. Subjects under 2 years old with complete DiGeorge syndrome     (atypical or typical) received thymus transplantation. Subjects received pre-transplant     immune suppression with rabbit anti-human-thymocyte-globulin. Subjects with     hypoparathyroidism and an eligible parental donor received thymus and parental parathyroid     transplantation. A primary hypothesis: Thymus/Parathyroid transplant subjects will need less     calcium and/or calcitriol supplementation at 1 year post-transplant as compared to historical     controls.   "
207641|NCT00566501|"     The purpose of this study is to evaluate the safety and efficacy of long-term administration     of 23 mg donepezil sustained release (SR) in patients with moderate to severe Alzheimer's     disease. Patients who complete study E2020-G000-326 with no ongoing serious adverse events     (SAEs) and no serious adverse drug reactions will be eligible to enter the open-label     extension study.   "
207642|NCT00566514|"     The purose of this research study is to determine the potential benefit of D-ribose, a     nutritional supplement (a sugar), versus a placebo (another sugar) in people with     fibromyalgia.   "
207643|NCT00566527|"     -  Primary objectives:             -  To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month               interval to healthy children of 11 months of age at the time of Dose 1 is as               immunogenic as in healthy children of 12 months of age at the time of Dose 1.             -  To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month               interval to healthy children of 9 months of age at the time of Dose 1 is as               immunogenic as in healthy children of 12 months of age at the time of Dose 1.             -  To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month               interval to healthy children of 11 months of age and 9 months of age at the time of               Dose 1 is well-tolerated compared to children of 12 months of age at the time of               Dose 1.        -  Secondary objectives             -  To describe the antibody titres to measles, mumps, rubella and varicella at Day 42               following Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9               months of age.             -  To evaluate the safety profile of Dose 1 and Dose 2 of ProQuad® rHA administered to               healthy children from 9 months of age.   "
207644|NCT00566540|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination     chemotherapy together with radiation therapy before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed. Giving these treatments after     surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving cisplatin and paclitaxel together     with radiation therapy and surgery works in treating patients with advanced cancer of the     oral cavity, oropharynx, or hypopharynx that can be removed by surgery.   "
207645|NCT00566553|"     The role of estrogens in the pathogenesis of breast cancer has been well documented. This has     led to the development of Anti-Estrogens (selective estrogens receptor modulators and     Aromatase Inhibitors), used for treatment and prevention of breast cancer. These agents,     however, have significant side effects, which are not acceptable to many healthy high-risk     women. There is preliminary evidence that grape seed extract acts as natural aromatase     inhibitor (1). This study has the potential to quantify the effectiveness of a natural     substance that mimics the action of pharmaceutical aromatase inhibitors.   "
207646|NCT00566566|"     Background: Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It     accounts for 25% of all childhood cancers. Peak incidence occurs between 2 to 5 years of age.     Modern treatment regimens have improved cure rates from virtually zero (in the 1950's) to     current overall survival rates of approximately 80%.The high survival rates have introduced     us to novel medical problems as a consequences of the different treatment regimens. No single     treatment modality exists today but rather several treatment protocols are accepted     worldwide. As such, the population of the childhood ALL survivors differ in their toxic     exposure: cranial & spinal radiotherapy, intrathecal and/or systemic chemotherapy and bone     marrow transplantation .As the survival rates grow, there are more young adult ALL survivors     worldwide susceptible to these late effects of treatment.      Numerous reports have pointed out that this particular group is at increased risk to develop     cardiovascular disease (CVD) and diabetes (MS). The metabolic syndrome, i.e hypertension,     dyslipidemia, impaired glucose metabolism and obesity, occurs at a younger age than the     general population.      Adipocytokines, mediators secreted by adipose tissue, play an important role in the     regulation of carbohydrates and lipid metabolism.Changes in serum adipokine levels precede     the clinical symptoms.      We aim to identify and assess prevalence of the MS in ALL survivors. We aim to characterize     the population at risk to develop DM and CVD prior to overt clinical disease.     Characterization will be done by measuring serum adipocytokines and inflammatory cytokine     profiles .Biochemical characterization of the group at risk will enable us to intervene in     the preventive stage in the future.   "
207671|NCT00566904|"     Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that     causes chicken pox. Some people experience continued pain even after the shingles rash and     blisters have healed; this pain is known as postherpetic neuralgia. The purpose of this study     is to evaluate the effectiveness of a new topical treatment for postherpetic neuralgia in     adults.   "
207742|NCT00567840|"     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral     administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly     diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard     TB treatment.   "
207743|NCT00567853|"     The purpose of this study is to collect data on the effectiveness and clinical outcomes of     the MEMO 3D Annuloplasty ring as used for mitral valve repair.   "
207647|NCT00566579|"     Persistent human papillomavirus (HPV) infections is the single necessary cause of cervical     cancer. Cervical cancer is still the major health problem in the developing countries. It has     been the first rank women's cancer in Thailand for many decades. Approximately 10-20% of Thai     women have the high-risk HPV (HR-HPV) infections in their cervices. This will frequently lead     to low-grade squamous intraepithelial lesions (LSILs) (10%), high-grade squamous     intraepithelial lesions (HSILs) (0.8%), and finally, cervical cancers (0.16%) within 10-20     years. The treatment options for LSILs are either observation or ablative surgery. However,     in our institute, cryotherapy, which is the one of ablative surgery, is more frequently used     to comfort our women. It is not only effective but safe with only minimal side effects;     watery leukorrhea for 2-4 weeks, and local cervical infection not more than 1%.     Contraindication to this procedure are active cervical infection, lesion of 2 mm-larger than     probe, lesion inside cervical os and suspected cervical cancer. Additionally, in developing     countries such as Thailand, this treatment is safe, acceptable, feasible and effective.     Patients with LSILs could also have this treatment in some rural area from the 10-days     trained nurses. Fortunately, recent reports showed that cryotherapy has abilities not only in     clearing LSILs but also clearing the HPV infections, its necessary cause. However, there are     no randomized controlled trial compared its clearing ability between observation and     cryotherapy. Therefore, a randomized controlled trial is needed to demonstrate that. Findings     from this trial will contribute enormously to older women who already get infected by HPV.     Aside from preventing cervical cancer in treated woman, cryotherapy could also give her     relief from worrying about having a time-bomb like HPV infection in her cervix.   "
207648|NCT00566592|"     Hypoglycemia is the principal barrier to the achievement of target glycemic goals in type 2     diabetes. Alcohol consumption is very prevalent in our society and a proven cause of     hypoglycemia. Population studies suggest that elderly, insulin requiring type 2 diabetes     patients are particularly vulnerable to severe hypoglycemia and that this problem accounts     for an estimated $50 million or more in healthcare costs in the USA each year. We hypothesize     that low dose ethanol significantly increases the vulnerability to overnight hypoglycemia and     impairs the recovery of plasma glucose in elderly, insulin requiring patients with type 2     diabetes. Our preliminary studies suggest that low dose ethanol impairs recovery from day     time insulin-induced hypoglycemia in type 2 diabetes patients but not in age matched healthy     control subjects. The proposed studies will examine the effects of low dose ethanol on     overnight glucose regulation in elderly, insulin requiring type 2 diabetes patients and will     establish the mechanism of these impairments through a series of systematic evaluations.     Specifically, these studies will document suppression of the dawn phenomenon by ethanol,     and/or exacerbation of a deficient counterregulatory response to hypoglycemia during sleep,     especially growth hormone. Specific mechanisms for the suppression of growth hormone to be     examined include that evening ethanol (3) inhibits peak overnight ghrelin secretion and/or     (4) reduces pituitary sensitivity to GHRH. Additionally, these studies will characterize (5)     the dose response characteristics of ethanol on overnight glucose homeostasis and will (6)     carefully evaluate the effect of the timing of ethanol administration in relation to meal     ingestion on overnight hypoglycemic vulnerability. To address these aims, we will assess the     effect of moderate doses of orally administered ethanol or placebo on overnight growth     hormone release, ghrelin, total IGF-1, free IGF-1, insulin-like growth factor binding protein     1 (IGFBP-1) concentrations, glucose production and other parameters of glucose homeostasis     among elderly control subjects versus elderly, insulin requiring subjects with type 2     diabetes. These important studies will provide a scientific basis for the prevention of     overnight hypoglycemia (and the attendant cost savings) by providing mechanistic insights     into the causes of nocturnal hypoglycemia.   "
207649|NCT00566605|"     To compare the early visual results and postoperative recovery between two groups of     keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine     procedure while the second group underwent femtosecond-enabled penetrating keratoplasty.   "
207650|NCT00566618|"     The goal of this clinical research study is to find the highest tolerable dose of dasatinib     and Zometa (zoledronic acid) that can be given in combination for the treatment of breast     cancer that has spread to the bone. The safety and effectiveness of this combination will     also be studied.   "
207651|NCT00566631|"     The purpose of this study is to evaluate the tolerability, safety and treatment response of     flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the     body over an extended period of time) tablets in participants with acute schizophrenia     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often     with delusions and hallucinations, and withdrawal into the self).   "
207652|NCT00566644|"     RATIONALE: The use of intrauterine levonorgestrel may prevent atypical endometrial     hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer     or Lynch syndrome. It is not yet known whether intrauterine levonorgestrel and observation     are more effective than observation alone in preventing atypical endometrial hyperplasia and     endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch     syndrome.      PURPOSE: This randomized phase III trial is studying intrauterine levonorgestrel and     observation to see how well they work compared with observation alone in preventing atypical     endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis     colorectal cancer or Lynch syndrome.   "
207653|NCT00566657|"     Primary objective is to demonstrate the superiority of riferminogene pecaplasmid     (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the     treated leg or of death from any cause, whichever comes first, in critical limb ischemia     (CLI) patients with skin lesions.      Secondary objectives are to evaluate:        -  The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major          amputation;        -  The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;        -  The safety of riferminogene pecaplasmid in the study population.   "
207654|NCT00566670|"     National Kidney Foundation guidelines recommend a dietary protein intake of 1.2 grams per     kilogram per day (g/kg/d) in hemodialysis patients. However, it is unclear whether     consumption of high amounts of protein in dialysis patients has beneficial or harmful     nutritional and cardiovascular effects in this population. High protein intake might improve     nutritional status, but it has been argued that the state of low muscle mass, small body size     and low serum protein levels is not the result of decreased dietary intake, rather a result     of hypercatabolism induced by metabolic acidosis, inflammation and oxidative stress.      The specific aims of this study are to examine in a prospective cohort of hemodialysis     patients the longitudinal associations of absolute total protein intake or dietary protein     intake with muscle mass and arterial stiffness.   "
207655|NCT00566683|"     Colonoscopy is a common endoscopic procedure as an investigation of colorectal pathology.     Different modalities of pain control have been described in the past. Propofol is a perfect     drug for endoscopic procedure since it has the characteristic of fast onset, short half-life     and early recovery. Its unfamiliarity and its potential cardiovascular and respiratory side     effect make it unpopular to endoscopists. Recent reports showed propofol is safe in bolus     titration by nurse in Caucasian in all endoscopic procedures. Our previous pilot study showed     nurse administered propofol sedation (NAPS) is effective and safe and highly acceptable by     Chinese patients. Here we conduct a randomized controlled study to compare the effectiveness     of NAPS versus traditional sedation.   "
207740|NCT00567814|"     Subjects will be randomly assigned to receive either one of the two potential dose     combinations of the study medications or placebo over 6 weeks. The study will include twice     weekly visits to the research clinic for laboratory studies, safety assessments and urine     drug screens. Subjects will also be questioned regarding drug craving and mood symptoms.   "
207656|NCT00566696|"     Blood and marrow stem cell transplant has improved the outcome for patients with high-risk     hematologic malignancies. However, most patients do not have an appropriate HLA (immune type)     matched sibling donor available and/or are unable to identify an acceptable unrelated HLA     matched donor through the registries in a timely manner. Another option is haploidentical     transplant using a partially matched family member donor.      Although haploidentical transplant has proven curative in many patients, this procedure has     been hindered by significant complications, primarily regimen-related toxicity including GVHD     and infection due to delayed immune reconstitution. These can, in part, be due to certain     white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize     the body tissues of the patient (the host) are different and attack these cells. Although too     many T cells increase the possibility of GVHD, too few may cause the recipient's immune     system to reconstitute slowly or the graft to fail to grow, leaving the patient at high-risk     for significant infection.      For these reasons, a primary focus for researchers is to engineer the graft to provide a T     cell dose that will reduce the risk for GVHD, yet provide a sufficient number of cells to     facilitate immune reconstitution and graft integrity. Building on prior institutional trials,     this study will provide patients with a haploidentical (HAPLO) graft engineered to specific T     cell target values using the CliniMACS system. A reduced intensity, preparative regimen will     be used in an effort to reduce regimen-related toxicity and mortality.      The primary aim of the study is to help improve overall survival with haploidentical stem     cell transplant in this high risk patient population by 1) limiting the complication of graft     versus host disease (GVHD), 2) enhancing post-transplant immune reconstitution, and 3)     reducing non-relapse mortality.   "
207657|NCT00566709|"     Neurocritical ill patients are frequently transfused. Red blood cell transfusion (RBCT) in     these patients has been associated with deleterious effects, including higher rates of     nosocomial infections, multi-organ failure, and mortality. Therefore, it seems crucial to     avoid any unnecessary RBCT.      Most critically ill patients tolerate hemoglobin levels near 7 g/dL without an increase in     morbidity or mortality rates. In this regard, a recent sub-analysis of TRICC trial has showed     that TBI patients may tolerate hemoglobin levels as low as 7 g/dL, but other studies     including neurocritical patients suggested that severe anemia may worsen clinical outcome.     Therefore, optimal hemoglobin levels in neurocritical care patients remain largely unknown.     Some textbooks and guidelines recommend to transfuse these patients to reach hemoglobin     levels near to 10 g/dL, despite the lack of a solid scientific background supporting this     target.      Even though it has not been demonstrated, hemoglobin-based RBCT prescription could result in     over- or under-transfusion in neurocritical patients. Alternatively, it has been suggested     that more physiological transfusion triggers, using direct signals coming from the brain,     will progressively replace arbitrary hemoglobin-based transfusion triggers in the     neurocritical patients [65]. At the neurocritical units, patients are often monitored by     using non-invasive methods, such as near infrared spectroscopy which indirectly measures     regional cerebral oxygen saturation (rSO2). Changes in rSO2 values have been shown to     directly correlate with changes in erythrocyte mass, thus increasing with RBCT and decreasing     with blood losses. Moreover, rSO2 values also show a good correlation with clinical outcome     and other variables which are often monitored in TBI patients.      The purpose of this study is to ascertain as to whether rSO2 levels are more efficacious than     conventional hemoglobin levels in guiding RBCT in patients admitted to a neurocritical care     unit.   "
207658|NCT00566722|"     The objective of this study was to evaluate the safety and efficacy profile of Humira     (adalimumab) in patients who had a sub-optimal response to prior systemic therapy. This     open-label study was conducted in a patient population of moderate to severe chronic plaque     psoriasis patients, which is an approved patient population for adalimumab.   "
207659|NCT00566735|"     The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat     problems with thinking and memory caused by electroconvulsive therapy (ECT).   "
207660|NCT00566761|"     Treatment of macular edema secondary to central retinal vein occlusion is more effective with     combined therapy of bevacizumab and triamcinolone than bevacizumab alone.   "
207661|NCT00566774|"     The objective of this randomized trial is to evaluate the effect of providing full     prescription drug coverage (i.e. no co-pays, co-insurance or deductibles) for statins,     beta-blockers, angiotensin converting enzyme inhibitors and angiotensin II receptor blockers     to patients recently discharged from hospital after acute myocardial infarction.   "
207662|NCT00566787|"     RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched     concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System   "
207663|NCT00566800|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Erlotinib     may keep esophageal cancer from forming in patients with Barrett esophagus by blocking some     of the enzymes needed for cell growth.      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with     Barrett esophagus.   "
207664|NCT00566813|"     The primary purpose of this study is to demonstrate the safety of allogeneic islet     transplantation in type 1 diabetic patients performed at the University of Illinois at     Chicago (UIC). The purpose is to reproduce the Edmonton protocol to demonstrate that     pancreatic islets isolated at UIC are safe and of sufficient quality to provide reproducible     graft function.   "
207665|NCT00566826|"     Knee osteoarthritis is one of the most common causes of disability in older adults. Total     knee replacement (TRK) surgery is often an effective solution when persistent pain does not     sufficiently improve with non-surgical treatment. Although most TKR surgeries are a success,     an estimated 15% to 30% of patients report no clinically significant improvement in function     12 months after a TKR. This study will evaluate the effectiveness of a patient support     program in increasing physical function after a TKR surgery.   "
207666|NCT00566839|"     Lung volume reduction surgery is effective in improving pulmonary function and quality of     life in selected patients with severe emphysema although the morbidity of this surgical     procedure is still considerable. Morbidity is mainly addressed to general anesthesia-related     adverse effects and surgical trauma deriving from lung resection. Having developed an awake     nonresectional lung volume reduction surgery technique, which is performed under sole     thoracic epidural anesthesia, we have hypothesized that it could offer satisfactory clinical     results and reduced morbidity rate when compared with the conventional surgical procedure.   "
207667|NCT00566852|"     RATIONALE: Memantine may be able to decrease side effects caused by whole-brain radiation     therapy. It is not yet known if memantine is effective in preventing side effects caused by     whole-brain radiation therapy.      PURPOSE: This randomized phase III trial is studying memantine to see how well it works     compared to a placebo in preventing side effects caused by whole-brain radiation therapy in     patients with brain metastases from solid tumors.   "
207668|NCT00566865|"     The primary objective of this study is to determine the extent of effect of gemfibrozil on     the pharmacokinetics and pharmacodynamics of mitiglinide.   "
207669|NCT00566878|"     The objective is to determine if alglucosidase alfa is present in breast milk from mothers     with Pompe Disease being treated with alglucosidase alfa and to measure breast milk     production and composition in women with Pompe Disease who receive alglucosidase alfa.   "
207670|NCT00566891|"     This single-centre study is intended to retrospectively check the safety of high-dose bolus     of tirofiban in patients who underwent percutaneous angioplasty.   "
207672|NCT00566917|"     Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic     organs and vaginal walls to protrude. For decades, suture repair techniques have been the     primary choice of surgical treatment when indicated.      Traditional surgical techniques are frequently associated with unsatisfying anatomical     recurrence rates and it is plausible that inherently weak, or damaged, pelvic floor     supportive tissues need to be reinforced by a permanent support to avoid the high rates of     recurrences commonly described using traditional techniques. Over the years sporadic attempts     have been made to introduce novel surgical techniques using a variety of biomaterials with     varying success. Despite a lack of clinical safety data, or compelling clinical evidence     demonstrating that it improves outcomes compared to traditional suture techniques, use of     biomaterials in pelvic reconstructive surgery has become widespread in just a few years .      It is likely that biomaterials need to be anchored in tissues not afflicted by the disease,     in order to provide the intended pelvic floor support. This has given rise to transvaginal     surgical techniques using a transobturator approach passing the mesh through the arcus     tendineous fascia pelvis, or the sacrospinous ligaments through a transgluteal approach.     Short term data from concluded and on-going safety assessments of these techniques has     provided promising results and satisfying clinical outcomes. The aim of the present study is     to compare anterior mesh repair (PROLIFT®) with traditional suture repair in a randomised     trial.   "
207673|NCT00566930|"     The aim of this study is to determine which of tertiary prevention spinal manipulative     therapy (SMT) or a home exercise program is the more efficient approach to reduce pain and     increase functional capacity, quality of life and general health condition. To do so, 60     participants with chronic cervical pain, will be recruited and divided into 3 groups     according to the intervention they will receive: control group, experimental group 1 who will     receive preventive chiropractic care in the form of spinal manipulations and experimental     group 2 will have to perform an individualized home exercise program on a daily basis. We     hypothesize that a group of patient receiving SMT + a home exercise program will present less     pain and functional disabilities over a 1 year period. The innovative value of this project     is mainly related to the fact that it will generate new and potentially very useful data     concerning the clinical significance of preventive chiropractic care. Moreover, such data     will be beneficial to our profession as chiropractic makes a step towards prevention,     wellness and public health.   "
207674|NCT00566943|"     The purpose of this study is to verify the performance of PSD Veritas to provide staple line     protection during surgical procedures for obesity.   "
207675|NCT00566956|"     · What we know: Hydrosalpinx and IVF About 40% of patients undergoing IVF have tubal disease     and in 25%-30% of tubal disease patients there is fluid collection within the tube;     hydrosalpinx. The amount of fluid in the hydrosalpinx is known to increase with ovarian     stimulation (as in IVF) and often empties into the uterine cavity. Fluid from hydrosalpinges     has been found to be detrimental to the growth and development of mouse embryos in vitro, and     associated with reduced levels of endometrial integrins in vivo. This could be the     explanation of the reduced pregnancy rates after IVF in patients with tubal disease and     hydrosalpinx compared with those with tubal disease but no hydrosalpinx. This effect was     evidence in both fresh and frozen embryo transfer cycles. Also there was a significant     increase in miscarriage in association with hydrosalpinx.      The study aims to answer the question: does ultrasound-guided aspiration of ultrasound     diagnosed hydrosalpinx at the time of egg collection improve the pregnancy rate in IVF?   "
207676|NCT00566969|"     A total of 120 male and female opioid dependent cocaine users will participate in this study.     This study will be a 8-week double-blind, placebo controlled study examining the     dose-dependent effects of carvedilol (up to 50 mg/day) in methadone stabilized patients. The     design will have two phases: 1) a four-week treatment  phase; and 2) a 4 week  taper and     detoxification or transfer phase. Subjects will be cocaine users who are on stable doses of     methadone (60 to 140 mg/day). Carvedilol dose will be increased from 12.5mg/day to the target     dose of either 25 or 50 mg/day as tolerated. At the end of the treatment-phase, subjects will     undergo detoxification from methadone over a 2 to 4-week period based on an individual's     needs, and they will concurrently be tapered off carvedilol.   "
207677|NCT00566982|"     The purpose of this study is to determine the efficacy and long-term safety of 60mg     ospemifene in the treatment of VVA in postmenopausal women with intact uterus.   "
207678|NCT00566995|"     This study will examine the effectiveness of an investigational drug called ZD6474 (also     known as vandetanib or ZACTIMA). Vandetanib is an experimental drug that is designed to     prevent the growth and development of new blood vessels on tumors and to prevent the direct     growth of cancer cells. It has been tested in a number of clinical trials on adults with     cancer, but the United States (U.S.) Food and Drug Administration has not specifically     approved it as a cancer treatment. The purpose of this investigational study is to better     understand how vandetanib affects humans who have kidney cancer related to von Hippel-Lindau     (VHL) disease, and to develop tests that may improve researchers understanding of kidney     cancer and its effects.      Volunteers must be at least 18 years old and must have been diagnosed with kidney cancer     related to VHL. Candidates must have a life expectancy greater than three months and must     have at least one measurable renal tumor for study purposes. Candidates may not be receiving     any other investigational agents or have been treated with an investigational drug within the     past four weeks. Candidates who have had surgery, chemotherapy, or radiotherapy within the     past four weeks will be excluded from the study. Candidates will be screened with a physical     examination and medical history.      During the study, participants will receive an oral dose of vandetanib once a day for 28 days     (a treatment period known as a cycle). Participants will need to return to the National     Institutes of Health every two weeks on the same day of the week as the first dose of     vandetanib for a series of tests and procedures, including blood and urine tests and an     electrocardiogram. Every 12 weeks, computerized tomography (CT) or magnetic resonance imaging     (MRI) scans will be done to assess the size of participants tumors. Participants whose tumors     do not grow and who do not have unacceptable side effects may continue to receive vandetanib     to maintain the current condition, until researchers conclude the study....   "
207679|NCT00567008|"     The purpose of this study is to determine whether varenicline (Chantix), is effective for the     treatment of cocaine dependence.   "
207680|NCT00567021|"     This PMS study had the objective to evaluate under ordinary medical care conditions the     efficacy and tolerability of esomeprazole in patients who where treated by general     practitioners and internists.   "
207741|NCT00567827|"     Pneumonia is a common cause of morbidity and mortality. The diagnosis of pneumonia from the     microbiology perspective has been challenging. Recent reports suggest the utility of nuclear     acid detection for rapid and accurate diagnoses of these pathogens and their     antibiotic-resistant spectrum. Extracted bacterial nucleic acid in sputum specimen will be     identified by Nuclear acid detection assay kit with Microfluidic Pumping Chip and LAMP     methods   "
207681|NCT00567034|"     The main purpose of this study is to determine whether the opioid antagonist naltrexone is     helpful in ameliorating the weight gain and other adverse metabolic side effects experienced     by schizophrenic patients taking the second generation antipsychotic (SGA) Zyprexa.     Schizophrenics may have an altered/enhanced endogenous opioidergic drive, and because of     this, normally painful stimuli will be sensed as less painful in schizophrenics vs. healthy     controls. A secondary hypothesis for this study is that naltrexone augmentation of Zyprexa     will normalize subjective pain ratings. Our tertiary objective is to examine the safety and     tolerability of naltrexone in Zyprexa-treated patients with schizophrenia.   "
207682|NCT00567047|"     This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients     with mild, moderate or severe renal impairment and healthy volunteers.   "
207683|NCT00567060|"     The purpose of this study was to explore in a more documented way the relative potential and     efficacy of piracetam 9600 and 4800 mg daily.   "
207684|NCT00567073|"     The objective is to track pregnancy outcomes in women with Pompe Disease and to follow     infants born to women with Pompe Disease.   "
207685|NCT00567086|"     To evaluate the effects of a single sc administration of TEZAMPANEL at one of three different     dosage levels compared to placebo, employing traditional measures of efficacy and safety in     the treatment of a single episode of acute migraine.   "
207686|NCT00567099|"     The purpose of this study is the use of magnetoencephalography or MEG (a machine that     measures magnetic activity in your brain) and electroencephalography or EEG (a technique that     measures electrical activity in your brain) to study how sounds are processed in individuals     with schizophrenia prior to initiation with aripiprazole treatment and after three months of     taking the antipsychotic medication aripiprazole.   "
207687|NCT00567112|"     A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) & oral     compressed tablet (OCT) formulations of MK-0941-009 & to assess the effect of food on the OCT     formulation.   "
207688|NCT00567125|"     The purpose of the study was the comparative assessment of the influence of low and standard     pressure CO2 pneumoperitoneum on the systemic inflammatory and angiogenic responses during     the postoperative period after laparoscopic management of cholelithiasis.   "
207689|NCT00567151|"     The aim of this study is to elucidate the prevalence of nontuberculous mycobacterial (NTM)     co-infection in patients with smear positive pulmonary TB. To detect the NTM co-infection, we     will perform duplex PCR targeted for mycobacterial hsp 65 gene using sputa. In addition, the     clinical significance of this co-infection will be evaluated.   "
207690|NCT00567164|"     The purpose of this study is to determine whether the study drug is safe and effective.   "
207691|NCT00567177|"     We propose to investigate the response to Restasis, over a prolonged period of time in heavy     computer users with dry eye disease.   "
207692|NCT00567190|"     This study is a Phase III, randomized, double-blind, placebo-controlled, multicenter     international clinical trial. Participants who have HER2-positive metastatic breast cancer     (MBC) and have not received chemotherapy or biological therapy (including approved or     investigational tyrosine kinase/HER inhibitors or vaccines) for their metastatic disease are     eligible for study. Participants could have received one prior hormonal treatment for MBC.     Participants may have received systemic breast cancer treatment in the neo-adjuvant or     adjuvant setting, provided that the participant has experienced a disease-free interval (DFI)     of greater than or equal to (>/=) 12 months from completion of adjuvant systemic treatment     (excluding hormonal therapy) to metastatic diagnosis. Participants may have received     trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment.   "
207693|NCT00567203|"     The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose     regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy     for cognitive deficits in subjects with chronic symptoms of schizophrenia.   "
207694|NCT00567216|"     Gastric variceal bleeding has a very high rebleeding rate even after endoscopic variceal     injection of cyanoacrylate (GVO) which is considered the first choice of endoscopic     treatment. Beta-blocker (BB) is effective to lower portal pressure. We hypothesized     combination of GVO and BB can further decrease the rebleeding rate.   "
207695|NCT00567229|"     RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the     cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help     kill them or carry cancer-killing substances to them. Giving lenalidomide together with     rituximab may be an effective treatment for multiple myeloma.      PURPOSE: This phase II trial is studying the side effects of giving lenalidomide together     with rituximab and to see how well it works in treating patients with recurrent or refractory     multiple myeloma.   "
207696|NCT00567242|"     The purpose of this study is to determine if an intentional act improves treatment response     for patients with nonfluent aphasia. The treatment involves naming pictures and saying     members of categories. The intentional act requires initiating picture naming or category     member trials with a left-hand movement sequence. Nonfluent aphasia is a disorder of language     production in which patients with damage to the brain's language system have trouble     initiating and maintaining spoken communication. All patients participating in the study take     part in functional MRI scans to determine how treatments affect brain systems.   "
207697|NCT00567255|"     The purpose of this study is to determine whether the combination of naltrexone SR and     bupropion SR is safe and effective in the treatment of obesity.   "
207698|NCT00567268|"     The objective of the this surveillance is to collect information about 1)adverse drug     reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of     adverse drug reactions in this surveillance, and 3) factors considered to affect the safety     and/or efficacy of this drug.   "
207699|NCT00567281|"     This trial is designed to determine if administering repetitive transcranial magnetic     stimulation (rTMS) simultaneously to two sites in the temporal lobes, one on the left and one     on the right, produces greater improvements in voices and other symptoms of schizophrenia     compared to rTMS given to just one site in the temporal lobes.   "
207980|NCT00570284|"     The primary purpose of this study is to evaluate the effect of food on oral LBH589 in adult     patients with advanced solid tumors. This study will also evaluate the safety and efficacy of     LBH589 in adult patients with advanced solid tumors   "
207700|NCT00567294|"     Osteoporosis is a common bone disease in older adults in which the bones become weaker and     prone to fracture. Medications are available to slow or even stop disease progression.     However, very few adults who are prescribed osteoporosis medications actually follow through     with filling their prescriptions and taking the medications. Ways to improve medication use     have not been well developed or adequately tested. The purpose of this study is to evaluate a     telephone coaching program, with or without helpful adherence notifications to doctors, in     improving treatment adherence in older adults who are starting an osteoporosis medication.   "
207701|NCT00567307|"     The purpose of this pilot study is to provide data on the feasibility of conducting a large     clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme     inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease     (CVD). We hypothesized that A polypill comprising the aforementioned four components would     significantly reduce the estimated 10-year total CVD risk score with high adherence and no     significant increase in adverse effects compared to the standard practice.   "
207702|NCT00567320|"     Cocaine addiction continues to be an important public health problem in the US with a     significant cost to the individual and society. Among substance abusers, cocaine use has been     recognized as a significant problem especially in methadone-maintenance patients. In several     studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those     in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer     1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor     clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective     pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is     of great importance. Unfortunately, such effective pharmacotherapies do not exist.        1. To determine the safety and tolerability of varenicline in cocaine-using          methadone-stabilized subjects.        2. To determine if varenicline is efficacious in reducing cocaine-use in          methadone-stabilized subjects.   "
207703|NCT00567333|"     This study proposes to compare two innovative treatment approaches for LBP, both of which     focus on delivering individualized care through evidence-based, clinical care pathways.      The primary aim of the project is to determine the relative clinical efficacy of 1)     chiropractic care and 2) multidisciplinary, integrative care in 200 patients with sub-acute     or chronic LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The     primary outcome measure in this study is patient-rated back pain.      Chiropractic care will include therapies within the professional scope of practice.     Integrative, multidisciplinary care will include chiropractic, massage therapy, traditional     Chinese medicine (including acupuncture), medication, cognitive behavioral therapy, exercise,     and patient education.      Secondary aims are to assess between group differences in frequency of symptoms, disability,     fear avoidance behavior, self efficacy, general health, improvement, patient satisfaction,     work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and     providers' perceptions of treatment will be described using qualitative methods and     cost-effectiveness and cost utility will be assessed in the short- and long-term.      This innovative study is an exciting collaboration between an experienced and established     team of chiropractic, conventional, and CAM professionals dedicated to advancing the care of     pervasive and costly LBP conditions. This trial will provide new and important information     for all health care providers and LBP patients, informing decision making and improving care     delivery systems.   "
207704|NCT00567346|"     The study is assessing efficacy and safety of three different dosage regimens of grass pollen     sublingual immunotherapy in adult patients suffering from grass pollen related     rhinoconjunctivitis.   "
207705|NCT00567359|"     In this research study erlotinib will be given to eligible participants whose lung cancer has     been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung     cancer, and must have 1 or more of the following characteristics: be female, be of Asian or     Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be     examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is     overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific     mutations and the participant must have one of these mutations in his tumor.      Erlotinib blocks this protein and may control tumor growth and increase survival. Previous     research has shown that erlotinib is most effective for people who have these specific     mutations in the EGFR.   "
207706|NCT00567372|"     Posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema   "
207707|NCT00567385|"     This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the     new liquid growth hormone formulation, somatropin, in children with growth hormone     deficiency.   "
207708|NCT00567398|"     Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal)     in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated     Peritoneal Dialysis (APD) patients leads to improved metabolic control as measured by the     magnitude of change from the baseline value in the HbA1c levels.      Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs     Dianeal) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower     glycemic-control medication requirements, decreased incidence of severe hypoglycemic events     requiring medical intervention, improved metabolic control, nutritional status, and Quality     of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs     Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be     assessed.   "
207709|NCT00567411|"     The purpose of the study is to compare the safety and efficacy of two drops used to lower eye     pressure when given prior to a glaucoma laser procedure.   "
207710|NCT00567424|"     Study to determine drug interactions between GW273225 and the anticonvulsants valproate,     carbamazepine or phenytoin   "
207711|NCT00567437|"     One hundred patients with moderate to severe asymptomatic aortic stenosis (AS) will be asked     to exercise on a treadmill. NT-pro-BNP levels will be drawn before and after exercise.     Changes in NT-pro-BNP levels will be correlated to outcomes at one year. In the pilot phase     an additional 10 control subjects without AS will be enrolled to document the control     response of NT-pro-BNP elevations with exercise.   "
208005|NCT00570635|"     The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in     subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or     intolerant of Imatinib and/or Sunitinib.   "
207712|NCT00567450|"     In loco regional anesthesia, much more than for general anesthesia, the choice of the product     is largely left at the discretion of the practitioner. Two categories of local anesthetics     are distinguished according to their pharmacodynamic characteristics: products with a short     time of installation and a short duration period, and products with a longer delay of     installation of the sensitive and motor block, but with a long-term duration. Indeed, the     combined use of two products pharmacodynamically different seems to be of a practical     interest.      This study provides a comparison of the onset of action of 30 ml of ropivacaine 0.75% and     30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% for the subgluteal     sciatic nerve block. This is a prospective randomized double-blind study where the main     criterion of judgment is the time of installation of a sensitive block compatible with     surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect     a 50% decrease of the onset of action in the combination group with a power of 90% and alpha     to 5%, according to a previous pilot study. The secondary endpoints are the intensity and     time of installation of the motor block, the duration of sensitive and motor block, the total     dose of morphine administered within 48 hours, as well as its possible side effects.   "
207713|NCT00567463|"     -  The inflammatory process that leads to the development of asthma may be present before          the onset of asthma symptoms and cause a certain degree of airway hyperresponsiveness.          Without treatment it may induce irreversible airway structural changes that are          associated with permanent changes in airway functions, persistent airway          hyperresponsiveness and lead to the development of asthma symptoms.        -  Atopic subjects with asymptomatic airway hyperresponsiveness and first degree relatives          with a history of asthma are at higher risk to develop symptomatic asthma. Early          treatment of airway inflammation in these predisposed subjects with  borderline  or          mild airway hyper-responsiveness could prevent the development of asthma symptoms, and          reduce or even normalize airway responsiveness.        -  In very mild asthmatic subjects (bronchodilator need < thrice a week), early          anti-inflammatory treatment can lead to  normalisation  or airway responsiveness in a          significant number of subjects and prevent the need for subsequent regular therapy. This          is particularly true for those showing blood/sputum eosinophilia.      Objectives: To compare perception of bronchoconstriction, pulmonary function and airway     inflammation in subjects with mild symptomatic asthma and asymptomatic asymptomatic airway     hyperresponsiveness      Methods: To compare the influence of inhaled fluticasone propionate 250 mcg/day for 3 months     followed by 100 mcg/day for 9 months on airway inflammation and methacholine responsiveness     in a double-blind, placebo-controlled, parallel groups study including non-smoking atopic     subjects with mild asthma and asymptomatic airway hyperresponsiveness   "
207714|NCT00567476|"     This study investigated asthma-related quality of life in Brazilian patients using     omalizumab.   "
207715|NCT00567489|"     Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal     only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and     Automated Peritoneal Dialysis (APD)patients leads to improved metabolic control as measured     by the magnitude of change from the baseline value in the HbA1c levels.      Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal     only) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control     medication requirements, decreased incidence of severe hypoglycemic events requiring medical     intervention, improved metabolic control, nutritional status, and Quality of Life. In a     subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on     abdominal fat and left ventricular (LV) structure and function will be assessed.   "
207716|NCT00567502|"     This is an observational safety study being conducted in Europe comparing patients taking     Xagrid to patients taking other cytoreductive treatments. The plan is to enrol at least 750     subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The     study will collect follow up data for 5 years for each patient enrolled that will focus on     collecting data related to pre-defined events (PDEs) and Suspected Serious Adverse Reactions     (SSARs).   "
207717|NCT00567515|"     This study is to evaluate acute and long-term safety and effectiveness of Left atrial     appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied     in patients with atrial fibrillation (AF), paroxysmal, persistent and permanent, undergoing     cardiac surgery with a concomitant Maze/Ablation procedure.   "
207718|NCT00567528|"     This study was made to compare the efficacy of topical ibuprofen in gel form with oral     ibuprofen in the treatment of sub-acute soft tissue injuries while comparing the tolerability     of the delivery methods   "
207719|NCT00567541|"     The goal of this research study is to investigate safety and gather initial effectiveness     data for a new implanted device designed to treat chronic shoulder pain in chronic     post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1 x 0.1. It is     implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may     reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and     possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal     law to investigational use.   "
207720|NCT00567554|"     Anthracycline-taxane based chemotherapy regimens are recommended mainly by current guidelines     for neoadjuvant application of systemic treatment. The addition of other cytotoxic agents,     e.g. antimetabolites, vincaalkaloids, or platinum salts resulted in marginal increase in     efficacy, but was associated also with an increase in toxicity. Recently, only the addition     of the Her-2 antibody trastuzumab has significantly improved pathologic response rate.      Therefore, two major strategies are followed in current research projects:        -  To improve the selection of patients according to their tumors' sensitivity to          chemotherapy.        -  To implement small molecules with specific mechanism of action.      Within the GeparQuinto trial, the first strategy is followed by:        -  The PREDICT substudy. A gene signature specific for the response to anthracyclines and          taxanes will be prospectively evaluated for its ability to identify patients with chance          higher than 50% for a pCR. The results may leed to a better risk-benefit ratio for the          use of conventional chemotherapy.        -  Adapting further chemotherapy to the response of the tumor to the first couple of          chemotherapy cycles. Based on the previous experience made by the GeparTrio study,          patients not responding early have a low chance to respond with a pCR irrespective of          the type of chemotherapy. So, if further chemotherapy is planned, therapy should be          selected according to a favorable toxicity profile.      The second strategy is followed by investigating in three parallel group comparisons the     efficiency of three distinct small molecules which appear to be generally active in breast     cancer:        -  Bevacizumab, an inhibitor of the VEGF pathway targeting tumor neo-angiogenesis.        -  Lapatinib, an inhibitor of the Her-1 and Her-2 receptor tyrosine kinase.        -  RAD001 (Everolimus), an inhibitor of the mTOR molecule, a central controller of tumor          cell growth and angiogenesis and chemosensitizer.      Treatment for patients participating in the GeparQuinto study will be allocated according to     the Her-2 status of the tumor as well as according to the sonographic response after the     first 4 cycles of treatment. Experimental therapy with bevacizumab, lapatinib, and everolimus     (RAD001) will be randomly added in distinct settings.   "
207721|NCT00567567|"     This randomized phase III trial compares two different high-dose myeloablative chemotherapy     regimens followed by autologous stem cell transplant as consolidation treatment of younger     patients with high-risk neuroblastoma. All patients receive the same 6 cycles of initial     multi-agent chemotherapy induction regimen. Peripheral blood stem cells are collected after     the 2nd cycle of chemotherapy. Drugs used in chemotherapy work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     combination chemotherapy before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed. Patients underwent resection of their primary tumor     mass after 5 cycles of chemotherapy. Those patients without progressive disease at completion     of induction therapy who has sufficient stem cells collected and had adequate organ function     were eligible to proceed to consolidation therapy. Those patients who met consolidation     eligibility were randomized to either a single myeloablative regimen or 2 myeloablative     regimens delivered in tandem followed by re-infusion of autologous stem cells. Patients     received radiation therapy after recovery from the assigned myeloablative therapy. It is not     yet known which regimen of high-dose chemotherapy is more effective for patients with     high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.   "
207722|NCT00567580|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause     the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide,     and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by     the body. It is not yet known which regimen of radiation therapy with or without     androgen-deprivation therapy is more effective for prostate cancer.      PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how     well it works compared with short-term androgen deprivation therapy given together with     pelvic lymph node radiation therapy with or without prostate radiation therapy in treating     patients with a rising PSA after surgery for prostate cancer.   "
207723|NCT00567593|"     The purpose of this study is to determine the effect of rosiglitazone on the genes of the     colon   "
207724|NCT00567606|"     The purpose of this study is to test whether strength/weight training exercises enhance the     effectiveness of calcium, vitamin D, and risedronate for the prevention and treatment of     osteoporosis in postmenopausal breast cancer survivors.   "
207725|NCT00567619|"     Evaluate burden of disease in Patients with newly occurred upper GI symptoms related to GERD     (symptom frequency & severity, QoL, lifestyle modifications, self-medication) - baseline data     according to GERD impact scale presenting to specialists, especially internists      - Evaluate effect of treatment with a acid suppressive therapy on these parameters: looking     for improvement of symptom burden and quality of life according to the GERD impact sca   "
207726|NCT00567632|"     The determination of reference values is a necessary basis for research and clinical routine     testing for pneumococci antibodies   "
207727|NCT00567645|"     The purpose of this study is to assess whether baseline sympathetic innervation in patients     with chronic heart failure (CHF) is predictive for response to cardiac resynchronization     therapy (CRT). And to assess whether response to CRT coincides with restoration of regional     sympathetic innervation.   "
207728|NCT00567658|"     The purpose of this research study is to measure the effects of the drug, esomeprazole 40 mg     (Nexium) or placebo (inactive drug) on vocal cord granulomas.   "
207729|NCT00567671|"     Prospective, randomized, single site study to determine the safety and effectiveness of     performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with     corneal ectasia or progressive keratoconus.   "
207730|NCT00567684|"     The goal of this clinical research study is to use computed tomography urography (CTU) scans     and intravenous urography (IVU) scans to check the status of urothelial cancer, in order to     try to learn the level of effectiveness of possibly using CTU by itself in future patients.   "
207731|NCT00567697|"     A prospective multicenter study comparing patients with CRVO amd secondary macular edema     treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be     randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will     be monthly visits with injection the first three months and subsequently new injection if     present edema.   "
207732|NCT00567710|"     This is a prospective, six-week, randomized, double blind, placebo-controlled, multi-center     study in patients with schizophrenia who are experiencing an acute exacerbation of psychosis.   "
207733|NCT00567723|"     Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are     receiving dialysis will be followed for 5 years to compare mortality, bone fractures and     incidence of selected morbidities to patients with no lanthanum exposure and to patients     being treated for hyperphosphatemia with any marketed product.   "
207734|NCT00567736|"     The aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in     patients with chronic low back pain compared to waiting list group, or placebo.   "
207735|NCT00567749|"     This study is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc.     Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests)     in pediatric subjects who are between 12 and 17 years of age. A minimum of ten (10) known     HIV-positive participants will be tested.   "
207736|NCT00567762|"     To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in     patients with vernal keratoconjunctivitis   "
207737|NCT00567775|"     This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic     profile of two different methods of insulin administration in children with type 1 diabetes.   "
207738|NCT00567788|"     This is a randomized observer-masked cross-over study to compare the intraocular pressure     (IOP) reducing effect of latanoprost with bimatoprost in subjects with chronic angle closure     glaucoma (CACG) with raised IOP. Study subjects will be randomized to receive either     latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be     crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the     medications will be assessed by the reduction in IOP after each medication compared to     baseline. The study will be carried out in at least 2 Singapore hospitals.   "
207739|NCT00567801|"     The purpose of this study is to prove the findings of a preliminary study which strongly     suggest the hypothesis that the result of conventional embolectomy for acute, severe     lower-limb ischemia can be improved by controlled reperfusion.   "
207744|NCT00567866|"     This study will test the ability of a medicine (Quetiapine) that is used to treat     schizophrenia or bipolar disorder to reduce the effects of methamphetamine that make it     difficult for users to stop using it. This study will test the ability of a medicine that is     used to treat schizophrenia or bipolar disorder to reduce the effects of methamphetamine that     make it difficult for users to stop using it. The investigator thinks quetiapine will lessen     the effects of methamphetamine.   "
207745|NCT00567879|"     The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both     intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and     efficacy of the combination in adult female patients with HER2+ metastatic breast cancer   "
207746|NCT00567892|"     The goal of this trial to see if repetitive transcranial magnetic stimulation (rTMS) to the     hearing area of the brain can lessen the perception of tinnitus. rTMS uses a strong magnet     and when placed against the scalp generates a small electrical field within the brain.     Depending on the frequency of the stimulation, this electrical field can either decrease or     increase the electrical excitability of the brain. In this study, low-frequency stimulation     will be used, which is thought to decrease nerve activity. It is this electrical excitability     of the brain that is thought to be responsible for tinnitus.      The hypothesis of this study is that rTMS can decrease the perception of tinnitus.   "
207747|NCT00567905|"     The purpose of this study is to examine the effect of green tea extract (GTE) on type 2     diabetes and to explore the relationship between GTE and related hormone peptides.   "
207748|NCT00567918|"     To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients     with vernal keratoconjunctivitis   "
207749|NCT00567931|"     This phase I trial is studying the side effects and best dose of 1-methyl-D-tryptophan in     treating patients with metastatic or refractory solid tumors that cannot be removed by     surgery. Biological therapies, such as 1-methyl-D-tryptophan, may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth and by stimulating the immune     system.   "
207750|NCT00567944|"     The purpose of this study is to evaluate the safety and efficacy of the BrainPort balance     device in improving balance in people with balance deficits due to stroke.   "
207751|NCT00567957|"     The purpose of this study is to determine whether remifentanil use in preeclamptic patients     may blunt hemodynamic response to intubation during general anesthesia for cesarean section.   "
207752|NCT00567970|"     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor     and cause less damage to normal tissue.      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic     radiation therapy in treating patients with liver metastases.   "
207753|NCT00567983|"     The purpose of this study is to evaluate the effect Restasis has in regards to disease     progression.   "
207754|NCT00567996|"     This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo     or salmeterol in patients with chronic obstructive pulmonary disease.   "
207755|NCT00568009|"     This is a randomized, double-blind, placebo-controlled, multi-center, sequential cohort study     in subjects with congestive heart failure (CHF) and impaired renal function who are on stable     furosemide treatment (³ 40 mg daily). A total of 50 subjects will be randomized to each     increasing dose level of SLV320 or placebo in a sequential fashion.   "
207756|NCT00568022|"     The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated     dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in     Japanese participants with metastatic breast cancer.   "
207757|NCT00568035|"     The purpose of this study is to determine whether QR-333 is safe and effective in the     treatment of diabetic neuropathy as compared to placebo.   "
207758|NCT00568048|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor     cells by blocking blood flow to the tumor. Giving temozolomide together with bevacizumab may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving temozolomide together with     bevacizumab works in treating patients with stage IV melanoma that cannot be removed by     surgery.   "
207759|NCT00568061|"     The purpose of this study is to assess whether or not inhaled nitric oxide can decrease     myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment     elevation MI (STEMI) who undergo successful percutaneous coronary intervention.   "
207760|NCT00568074|"     This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety     of repaglinide and Glurenorm® and Glucobay® given as the mono-therapy in Chinese subjects     being treatment-naive type 2 diabetics.   "
207761|NCT00568087|"     The present study is designed to find out if N-acetylcysteine works in reducing alcohol     drinking and craving.   "
207762|NCT00568100|"     The investigators' aim is to study the effect of pressure support ventilation at two levels     of PEEP and Pressure Support versus neurally adjusted ventilatory assist (NAVA) in COPD     patients.   "
207763|NCT00568113|"     The antioxidant effect of N-Acetyl cysteine can abort the inflammatory cascade responsible     for initiation of preterm labour especially among patients with reccurent preterm birth and     patients having bacterial vaginosis   "
207764|NCT00568126|"     The purpose of this study is to find out whether Maca Root is effective for treating sexual     dysfunction in females that is caused by antidepressant drugs. An additional aim of the study     is to document the safety and tolerability of maca root, as well as any potential side     effects that it causes.   "
207765|NCT00568139|"     Mitotane is standard therapy in the treatment of adrenocortical carcinoma. However, many side     effects are not well documented. Therefore, we are aiming at collecting data about side     effects in patients treated with mitotane   "
207813|NCT00556777|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     intraoperative radiation therapy may reduce the amount of normal tissue that needs to be     removed.      PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery     works in treating older women with stage I breast cancer.   "
207766|NCT00568152|"     A randomised three period cross over trial will be carried out in adults (19-64 years) to     assess the acute and chronic effects of a large dose of apple procyanidin (PA) compared with     a low dose of apple PA (negative control) and aspirin (positive control), on platelet     function and other risk factors of cardiovascular disease. Platelet function will be assessed     prior to a run in diet and at the start and end of each intervention. Volunteers will be     assigned at random to consume 230grams of low PA apple puree or high PA apple puree or     aspirin (75mg) each day for 2 weeks followed by a minimum 14 day wash out.      Hypothesis: Consuming apple PA reduces platelet function consistent with reduced risk of     cardiovascular disease.   "
207767|NCT00568165|"     The aim of the study is to compare clinical management of patients with acute decompensation     of heart failure, hospitalized in non cardiological ward, with the use of a mobile team     including a cardiologist with portable echocardiography and standard care. The hypothesis is     that a mobile team will lead to shorter hospitalization.   "
207768|NCT00568178|"     The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric     patients.   "
207769|NCT00568191|"     The Cirrus OCT provides due to the spectral domain technology a 2-fold resolution than     Stratus OCT generated in a comparable amount of time. Due to this higher resolution the     retinal surface and the retinal pigment epithelium can be identified more clearly, a     significantly reduced number of algorithm failures is expected   "
207770|NCT00568204|"     Atomised Methoxymethane-in-Aqua (MEXYN-A) a new topical self-chilled, non-steroidal,     non-flammable, pressurised spray which embodies in one simultaneous application, most of the     currently recognised and effective chemical, mechanical and thermal anti-pruritic therapies     and hydrotherapy.   "
207771|NCT00568217|"     We wanted to find out if the early use of antipyretics is capable in preventing recurrences     of febrile seizures. When a child has had his/her first febrile seizure, the parents were     instructed to give him/her antipyretic medication every time when the child had a new episode     of fever during two years.   "
207772|NCT00568230|"     Improvement of heart failure with moderate to severe mitral regurgitation using a     percutaneously delivered implanted device.   "
207773|NCT00568243|"     Background:        -  The relation between eye movement and brain function is a subject of interest to the          National Eye Institute.        -  By comparing eye movement in healthy volunteers to research conducted on patients who          have difficulty moving their eyes, the National Eye Institute hopes to develop and          improve diagnostic procedures for people with eye diseases.      Objectives:      -The purpose of this study is to understand how we see visual patterns and how we move our     eyes to see.      Eligibility:        -  Normal volunteers:             -  must have no serious illnesses and must be 18 years of age or older             -  who are 18 years of age or older must be willing to wear contact lenses that record               eye movement.             -  individuals with a history of eye or brain diseases, or previous eye or eye muscle               surgery, are not allowed to participate in this study. Individuals who are               currently using eye medications also are not eligible for the study.        -  Patients:             -  who are 18 years of age or older must be willing to wear contact lenses that record               eye movement.      Design:        -  Participants will visit the National Eye Institute outpatient clinic for examination and          testing.        -  Participants will be screened with a medical history and eye examination (including eye          pressure and eye movement tests).        -  Participants with healthy eyes will participate in eye movement testing experiments:             -  One or more sessions lasting less than three hours each.             -  Eye movements will be recorded with either a special contact lens or a               video/infrared camera system.             -  For the majority of the studies done under this protocol, only one or two sessions               will be required. A few studies recording very small eye movements will require               three or more sessions.   "
207774|NCT00568256|"     Ulcerative Colitis is an Inflammatory Bowel disease that is a life-long, relapsing disabling     disorder. Current treatments for Ulcerative Colitis are not satisfactory. Most medications     provide only partial relief, are not successful for at least 30% of patients, and have major     negative side effects. Mounting evidence indicates that stress is one of the important     triggers that activates symptoms of ulcerative colitis and therefore causes flare-up. The     primary aim of this study is to see if either of two 8-week Mind-Body courses has an effect     in reducing stress and affecting the course and severity of UC.      Hypotheses: Stress causes Ulcerative Colitis flare-up and stress reduction will prevent     Ulcerative Colitis flare-up.   "
207775|NCT00568269|"     The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method)     and Lichtenstein (open method) repair on primary inguinal hernia.   "
207776|NCT00568282|"     The primary aim of this study is to determine whether we can identify human lung cancer tumor     cells in the peripheral blood of lung cancer patients.   "
207777|NCT00568295|"     To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis     of the Knee   "
207778|NCT00568308|"     The purpose of this study is to determine if PI-88 is effective and safe in patients who have     had surgery to remove primary liver cancer.   "
207779|NCT00568321|"     This study will test the efficacy and safety of two doses levels of RN624 versus placebo for     the relief of pain caused by post-herpetic neuralgia (PHN).   "
207780|NCT00568334|"     The aim of this study is to evaluate a modified formulation of GSK Biologicals' live     attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative     impact on vaccine safety. This present study is undertaken to rule out any negative impact on     the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.   "
207781|NCT00568347|"     To evaluate the role of inhaled corticosteroids to suppress nitric oxide gas exchange in     stable patients with moderate-to-severe COPD who are current non-smokers and not on oral     corticosteroids.   "
207782|NCT00568360|"     Endoscopy is a standard part of the evaluation of patients with head and neck cancer used for     determining the extent of tumor involvement. However, not all areas involved by tumor are     apparent visually. Preliminary results indicate that compared with normal tissues, tumors     have abnormal levels of capillary oxygenation. The purpose of this study is to determine the     ability of non-pulsatile visible light tissue oxygen monitoring to differentiate normal and     tumor tissue based on capillary oxygenation during endoscopy Should this be possible, this     method could be used to mark tumor extent and invasion, even when that invasion is up to 5mm     blow the tissue surface.   "
207783|NCT00568373|"     Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible     patients.   "
207784|NCT00568386|"     To evaluate drop comfort, acceptability, preference and blur profile between two marketed     artificial tears in both dry eye and non-dry eye patient population.   "
207814|NCT00556790|"     To investigate the real value of a fast track protocol compared to a standard care protocol     regarding postoperative complications and hospital stay in a multicentric setting in an     intention to treat fashion.   "
207785|NCT00568399|"     Cardiovascular disease is the major cause of death in the hemodialysis population and     calcification of the major arteries (coronary, aorta, and carotid) are a play a central role     in this process. The major causes of the calcification are many, including high levels of     phosphorus, low levels of inhibitors of calcification, positive calcium balance, and     oxidative stress. Once vascular calcification is present, it is usually progressive. There is     no known treatment to reverse established vascular calcification.      Sodium thiosulfate has been used extensively and safely to treat calcific uremic arteriopathy     (a disease, in part due to calcification of small arteries) in dialysis patients. It     increases the solubility of calcium by up to 100,000 fold and is also a potent anti-oxidant.     It therefore has to potential to also decrease the amount of calcium in large arteries in     dialysis patients and, hence improve survival.      We will study hemodialysis (HD) patients at high risk for cardiovascular disease and death by     obtaining a multidetector computerized tomography (MDCT) Scan of the coronary arteries,     carotid arteries and aorta and an assessment of coronary artery stenoses by a simultaneous     intravenous infusion of contrast. At the same setting, we will perform tests of pulse wave     velocity (PWV) and carotid ultrasound carotid intima-media thickness(CIMT)studies. In those     patients at high risk for cardiovascular death, defined as a coronary artery calcification     score (CACS)of greater than 50, sodium thiosulfate at a dose of 12.5-25 gm/1.73 M2 will be     infused over 15-30 minutes after each dialysis treatment for 5 months. The above studies will     then be repeated.   "
207786|NCT00568412|"     To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and     adolescents with mild to moderate atopic dermatitis   "
207787|NCT00568425|"     The purpose of this study is show that intensity-modulated radiotherapy (IMRT), as compared     with conventional radiotherapy, improves the precision of tumor targeting and reduces the     acute and late effects of radiation toxicity when used to treat anal cancer. Results from     this work will provide a basis for incorporating the use of IMRT to treat anal cancer in     future treatment protocols.   "
207788|NCT00568438|"     The goal of this study is to study NIS expression in benign and malignant breast and thyroid     samples using archival formalin-fixed paraffin-embedded tissue sections.   "
207789|NCT00568451|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. It is not yet known     whether giving paclitaxel together with carboplatin is more effective than giving     temozolomide alone in treating patients with melanoma.      PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel     together with carboplatin or giving temozolomide alone works in treating patients with stage     IV melanoma.   "
207790|NCT00568464|"     The purpose of this clinical trial was to evaluate the efficacy and tolerability of the     sequential therapy of VCD/IE in the patients with ESFT.   "
207791|NCT00568477|"     To evaluate the benefit of rituximab in patients with CAN with histologically proven C4d     deposits and/or plasma cell and/or B-Lymphocyte (CD20+ cells) infiltration of their grafts.   "
207792|NCT00568490|"     The purpose of this study is to identify and confirm new blood and tissue markers for     prognosis and tumor hypoxia. Tumor hypoxia, or the condition of low oxygen in the tumor, has     been shown to increase the risk of tumor spread and enhance tumor resistance to the standard     treatment of radiation and chemotherapy in head and neck and lung cancers. We have recently     identified several proteins or markers in the blood and in tumors (including osteopontin,     lysyl oxidase, macrophage inhibiting factor and proteomic technology) in the laboratory that     may be able to identify tumors with low oxygen levels or more aggressive behaving tumors.   "
207793|NCT00568503|"     This will be a single dose Proof-of-Concept study in mild-to-moderate COPD patients. The     study will investigate the safety and tolerability of QAX028 as well as the bronchodilatory     effects of QAX028 compared to tiotropium and placebo in mild-to-moderate COPD patients.   "
207794|NCT00556491|"     This study proposes to investigate whether treatment with minocycline pre-operatively in     patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce     the occurence of kidney injury.   "
207795|NCT00556504|"     The primary objective of this study is to evaluate the effectiveness of TCM-700C as an add-on     treatment to the combination drug therapy (Peginterferon α-2b plus Ribavirin) for patients     with genotype 1 chronic hepatitis C infections. This will be demonstrated by a higher     sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks     after the termination of combinational drug treatment, compared with the placebo add-on.   "
207796|NCT00556517|"     A common soft tissue injury in sports involving sprinting and jumping is the hamstring     strain. In addition to the frequency of injury, hamstring injuries are also the most     recurrent soft tissue injury occurring in sport. There is a need for further research     concerning diagnosis and different prognostic parameters for the rehabilitating process.      The aims for this study are:      A longitudinal comparison of sonographic and MRI assessments of acute and healing hamstring     injuries.      A study investigating different biomechanical parameters in the process of determining     whether a former hamstring injured soccer player is fully rehabilitated. We hypothesize that     it is possible to use electromyography, muscle strength measurements and different tests on a     force platform to help determine this issue.   "
207797|NCT00556530|"     22q11.2 deletion syndrome is a genetic disorder that can cause heart defects, facial     abnormalities, and developmental and learning disabilities. The severity of the disorder can     vary widely among people. This study will analyze DNA from people with 22q11.2 deletion     syndrome to identify genetic variations that may affect the severity of the disorder.   "
207798|NCT00556543|"     The purpose of this study is to gather information about a device used to help fix broken     ribs.      Hypothesis: Rib fracture repair with the U-plate system is clinically durable and safe for     the indications of flail chest repair, acute pain control, chest wall defect repair, and rib     fracture non-union.   "
207799|NCT00556569|"     The purpose of this study is to determine if the Moving Smart program, a daily 10-minute     classroom-based exercise program, increases physical activity levels during the school day in     Bronx elementary school students.   "
207815|NCT00556803|"     The purpose of this study is to prospectively evaluate whether transcatheter arterial     chemoembolization (TACE) will improve the outcome of radiofrequency ablation for     hepatocellular carcinoma (HCC) or not.   "
207800|NCT00556595|"     Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in     paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of     possible electrical gaps versus primary electrophysiological ablation at the sites of     atrio-venous electrical breakthroughs with secondary circumferential ablation around the     pulmonary vein orifice   "
207801|NCT00556608|"     The purpose of this study is to prove the non-inferiority of the intra-articular injection of     hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to     Synvisc®.   "
207802|NCT00556621|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination     chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when     given together with cisplatin and radiation therapy and to see how well they work in treating     patients with stage II or stage III bladder cancer.   "
207803|NCT00556634|"     Background: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of     subjects after initiation of efavirenz (EFV) and may limit its use in certain patients.      Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV     given as a stepped dosage over 2 weeks versus the usual dosage.      Methods: Randomized, double blind, multicentric clinical trial in which a progressive dosage     (arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was     compared with conventional administration (arm B: 600 mg qd from the first day). All patients     received additional treatment with 2 NRTIs.      The incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type     scale specifically designed. Efficacy was assessed by percent of virological failures.   "
207804|NCT00556647|"     Patients who are admitted to the outpatient pulmonology department by a general practitioner     or specialist with a chest X-ray suspicious for lung cancer with an age between 18 and 80     years are suitable for participation. The X-ray and referral are studied by a chest physician     (by phone or fax ). Selected patients are invited to enter the study after answering a     questionnaire by phone (p. 31). The questionnaire screens patients' interest, co-morbidity     and medication use. Informed consent forms, patient information forms and a time table for     the diagnostic day are provided by mail or E-mail in cases where time gets short. Waiting     time to enter the study will be no longer than one week.      Hundred patients will be recruited by means of informed consent. Patients will be admitted at     the pulmonary ward for the study day and will be accompanied by nurses. All patients will get     PET-CT scanning in the morning of the study day. Depending on the location of lesions seen on     PET-CT, further invasive diagnostic procedures will be planned for the afternoon.      Mediastinal and adjacent structures will be analysed with EUS-FNA. Mediastinal staging will     be done with bronchoscopy alone for central located tumors, peripherally located lesions will     be analysed with EUS-FNA or bronchoscopy.      The percentage of patients in which this diagnostic track leads to a diagnosis and tumor     stage in one day will be determined. The number of tests and diagnostic procedures needed to     obtain a diagnosis, including tumor stage (especially final stage NSCLC) and function tests,     will be compared with a historical matched study group. This historical study group is chosen     from an era before the availability of integrated PET-CT and ultrasound guided endoscopic     tools and meets the same inclusion and exclusion criteria as the patients in this study. The     timelines from initial chest X-ray to diagnostic day to informing the patient to start of     treatment will be determined. These figures will be compared with the historical study group.   "
207805|NCT00556660|"     The main objectives of this proposal are as follows:      To assess the dynamic uptake and washout of 123-I AV51, a potential imaging biomarker for     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in     similarly aged healthy controls and Alzheimer's (AD) subjects      To perform blood metabolite characterization of 123-I AV51 in healthy and AD subjects to     determine the metabolic fate and nature of metabolites in assessment of 123-I AV51 as a     single photon computed tomography (SPECT) brain imaging agent      Evaluate the test/retest reproducibility of 123-I AV51 and SPECT in AD subjects and healthy     controls   "
207806|NCT00556673|"     This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500     μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent     asthma.   "
207807|NCT00556686|"     The purpose of this study is to examine how compounds produced in patients with canker sores     affect wound healing.   "
207808|NCT00556699|"     This is an open-label, multicenter Phase Ib study designed to evaluate the safety,     pharmacokinetics, and preliminary efficacy of SGN-40 when combined with rituximab in patients     with relapsed CD20-positive, follicular or marginal zone NHL who have received at least one     prior rituximab-containing regimen.   "
207809|NCT00556712|"     This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva,     compared with placebo, following platinum-based chemotherapy in patients with advanced,     recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity     during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients     will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The     anticipated time on study treatment is until disease progression; the target sample size is     500+ individuals.   "
207810|NCT00556738|"     During caesarean section, transient respiratory distress which occurs frequently (3%) with     possible complications are at present managed by non invasive nasal continuous positive     airway pressure ventilation (nCPAP) associated with oxygen therapy. Intrapulmonary Percussive     Ventilation (IPV) is a non-invasive ventilatory mode used in some intensive care units to     treat some respiratory distress syndrome of the newborn with a good tolerance, but without     evaluation in prospective studies   "
207811|NCT00556751|"     An electrocardiogram (ECG) is a test that evaluates the electrical activity of the heart and     can be used to detect heart problems. By analyzing ECGs collected over a 20-year period, this     study will examine ECG abnormalities and the differences in ECG findings between black and     white people, from young adulthood through middle age.   "
207812|NCT00556764|"     The main objectives of this protocol are as follows:        1. To assess the sensitivity and specificity of ANAM-PD in detecting cognitive status in          patients with Parkinson disease (PD) and healthy controls (HC).        2. To validate the specific individual domains of the ANAM-PD cognitive battery by          comparisons to available standardized cognitive evaluation scales administered to the          patients with Parkinson disease with and healthy control subjects.        3. To evaluate the reliability of the ANAM-PD battery of tests by comparing repeated          administrations of the ANAM-PD battery on a sub-set of subjects with Parkinson disease          and healthy controls.        4. To characterize cholinergic neurotransmission through imaging the vesicular          acetylcholine transporter binding with 123Iodobenzovesamicol (IBVM) and SPECT in PD          patients and healthy controls.   "
207816|NCT00562315|"     Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence,     and lead to better characterization of disease status in restaging patients.      This is a study that will test a compound (chemical substance) that has a small amount of     radioactivity attached to it. This substance has a natural tendency to go to prostate tissue.     The substance is called [18]FACBC and it is given in the form of an injection into a vein.     After the substance reaches the prostate, scans called PET or Positron Emission Tomography,     are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is     used for PET scans but this substance is eliminated by the kidneys and cannot reach the     prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow     tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on     the prostate is cancer with scans or x-rays that are usually done.      Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the     conventional imaging for prostate cancer. Investigators will be blinded of the intervention.      This study will look at how the [18]FACBC goes into the prostate tissue and determine its     ability to detect recurrent prostate cancer.   "
207817|NCT00562328|"     RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or carry cancer-killing substances to them.     Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in     bone marrow or peripheral blood. Giving monoclonal antibody therapy together with GM-CSF may     be an effective treatment for early-stage chronic lymphocytic leukemia.      PURPOSE: This phase II trial is studying the side effects of giving rituximab and alemtuzumab     together with GM-CSF and to see how well it works in treating patients with early-stage     chronic lymphocytic leukemia.   "
207818|NCT00562341|"     The proposed prospective study aims to determine whether interpretation of PSA levels in     morbidly obese men require correction due to the obesity itself. If PSA levels are found to     rise after weight loss, interpretation of PSA levels in morbidly obese men may be improved by     upward correction of the PSA level. A 'correction factor' may be proposed for the     interpretation of PSA levels in obese men, toward the clinical decision regarding indication     for prostate biopsy.   "
207819|NCT00562354|"     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the     13-valent pneumococcal conjugate (13vPnC) vaccine in healthy Japanese adults aged >= 50     years.   "
207820|NCT00562367|"     We propose to investigate structural and biochemical brain abnormalities in depressed     subjects, and the relationship between the presence of such abnormalities and treatment     outcome. We will recruit N=20 subjects with major depression disorder and N=20 matched normal     controls. The depressed subjects would have previously not responded to an adequate trial     with a selective serotonin reuptake inhibitor (SSRI). These depressed subjects will be     treated for 4 weeks with the same SSRI antidepressant and with adjuvant triiodothyronine     (T3). Structural magnetic resonance images (MRI) and then Phosphorus-31 magnetic resonance     spectroscopic imaging (31P-MRSI) data will be obtained two times for each patient (at the     beginning and at the end of the study) and one time for the normal controls. We will measure     for each depressed subject the number of white matter hyperintensities (WMH); we will also     measure the degree of change from baseline in several compounds characteristic for the     cellular high-energy phosphate metabolism: the phosphocreatine/inorganic phosphate ratio and     the beta-nucleoside triphosphate. We will compare the severity of WMH and the high-energy     phosphate metabolism in two groups of depressed subjects (those responding and those not     responding to thyroid hormone augmentation) and the normal controls.      We hypothesize that:        1. All depressed subjects, when compared with normal controls, will present lower baseline          levels of compounds characteristic for the high-energy phosphate metabolism.        2. Depressed subjects responding to T3 augmentation, when compared with subjects not          responding to T3 augmentation, will present a larger increase of the high-energy          phosphate metabolism.   "
207821|NCT00562380|"     RATIONALE: Monoclonal antibodies, such as AMG-479, can block cancer growth in different ways.     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help     kill them or carry cancer-killing substances to them.      PURPOSE: This phase I trial is studying the side effects and best dose of AMG-479 in treating     patients with advanced solid tumors or non-Hodgkin lymphoma.   "
207822|NCT00562393|"     The prevalence of obesity has reached epidemic proportions and is associated with the     development of insulin resistance and type 2 diabetes (T2DM). A unifying theme has emerged     over the past few years suggesting that lipid oversupply to metabolic organs responsible for     glucose regulation leads to insulin resistance. Fitting with this, we and others have shown     that increased lipid accumulation within skeletal muscle and/or liver is associated with     impaired glucose uptake. However, the underlying mechanisms that mediate changes in muscle     lipid metabolism are not yet known. The overall aim of this project is to examine metabolic     effects of experimental weight gain in lean and overweight individuals with and without a     genetic predisposition to type 2 diabetes. We hypothesise that lean subjects will increase     fatty acid oxidation and upregulate mitochondrial oxidative capacity in muscle following     overfeeding to protect against body weight gain and insulin resistance, but overweight     subjects with a genetic predisposition to T2DM will have a defect in this ability.   "
207823|NCT00562406|"     The primary objective of this pilot study is to compare the functional and anatomic outcomes     of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon     laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a     combination of both.   "
207824|NCT00562419|"     RATIONALE: CT-322 may stop the growth of glioblastoma multiforme by blocking blood flow to     the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     CT-322 together with irinotecan may kill more tumor cells.      PURPOSE: This phase 2 trial is studying the side effects, tolerability, and efficacy of     CT-322 when given alone and in combination with irinotecan to patients with glioblastoma     multiforme.   "
207848|NCT00562731|"     Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in     clinical practice and has significant effects on patient well-being. The purpose of this     study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement     therapy in testosterone deficient men.   "
207825|NCT00562432|"     The primary goal of this study is to assess the safety of Plexisyl-AF administered by direct     application to the cardiac fat pads in patients undergoing coronary artery bypass grafting.     Secondary goals of the study are to assess the potential response of Plexisyl-AF to reduce     the occurrence of postoperative atrial fibrillation and assess the performance of the     electrostimulator device to confirm the location of the epicardial fat pads (nerves). The     occurrence of postoperative atrial fibrillation will be monitored by continuous cardiac     monitoring.   "
207826|NCT00562445|"     Observational study about the incidence of relative adrenal insufficiency in patients with     cirrhosis and acute variceal bleeding; in patients with acute peptic gastrointestinal     bleeding and without liver disease; and in patients with severe acute pancreatitis.      This is a study using pharmaceutical specialties in the approved conditions of use.   "
207827|NCT00562458|"     To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with     advanced breast cancer in whom a partial or complete response or stabilized disease were     obtained with first line chemotherapy, by tumoral response assessment.   "
207828|NCT00562471|"     The purpose of this study was to determine whether the adhesion prevention gel was safe to     use, and was effective for the prevention/reduction of adhesion formation that typically     occurs following gynecological surgery to remove myomas   "
207829|NCT00562484|"     This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza     Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a     population defined as being not at risk of severe complications following influenza     infection.   "
207830|NCT00562497|"     This is a Phase III, randomized, double-blind, placebo-controlled study to investigate the     efficacy and safety of Prochymal™ versus placebo in combination with corticosteroids as     initial therapy for acute GVHD. Corticosteroids have been the primary therapy for patients     with previously untreated acute GVHD and the historical published data define an expected 35%     complete response (CR) at Day +28 using this therapy.   "
207831|NCT00562510|"     This is a Phase 3, randomized, double blinded, placebo-controlled study designed to compare     the safety, tolerability, antiviral activity and immunological effect of raltegravir added to     a previously stable HAART regimen in the treatment of HIV-1 infected subjects with     undetectable viraemia and low CD4 recovery.      HYPOTHESIS:      Adding raltegravir to a stable HAART in patients with undetectable plasma viral load and low     CD4 recovery will result in further viral suppression and therefore higher CD4 recovery.   "
207832|NCT00562523|"     The purpose of this study is to: 1.) Evaluate how your body reacts to sorafenib when taken     daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the     safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at     specific times after taking the medications.   "
207833|NCT00562536|"     The overall objective of the present study is to examine the effects of delayed umbilical     cord clamping in preterm infants on neonatal outcomes using a prospective randomized     controlled trial comparing immediate cord clamping (standard at present) with delayed cord     clamping.      Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping     improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late     onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to     be examined include improvements in the following: 1) lung function as assessed by oxygen     dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as     assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring     intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need     for transfusion during stay in the NICU, and number of transfusions.   "
207834|NCT00562549|"     The purpose is to determine the effective dosage and to study the effects of this dosage     taken for 12 days on systolic and diastolic blood pressure in patients with hypertension.   "
207835|NCT00562562|"     This is a pilot project intended to determine the feasibility of detecting soft tissue     changes in response to osteopathic manipulative treatment (OMT). MRIs of the lumbar and     pelvic regions of low back pain (LBP) patients will be taken once before and at two different     time points after OMT. Images obtained will be quantitatively analyzed for changes in the     volumes of back muscles and for changes (T2 signals) indicative of activity levels or     pathological conditions. Electromyography (EMG) will be used as an independent measure of     back muscle activity for comparison with MRI results.   "
207836|NCT00562575|"     The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects     with high triglycerides.   "
207837|NCT00562588|"     German stroke units are hesitating to use Aggrenox for secondary ischaemic stroke / transient     ischaemic attack (TIA) prevention in a sub-acute treatment setting. They argue that clinical     experience with sub-acute Aggrenox treatment is limited and poorly documented when compared     with sub-acute acetylsalicylic acid (ASA) treatment. However, long term treatment (started     after 3-6 months after stroke/TIA) with Aggrenox was safe and superior to ASA treatment in     preventing recurrent strokes. There is no evidence for ASA to prevent from neurological     progression after stroke during the first 3 months. Results from a cohort study suggest that     starting Aggrenox within 72 hours after stroke predicts clinical improvement in the National     Institute of Health Stroke Scale (NIHSS) at discharge from the hospital. Dipyridamole     suppresses acute inflammatory responses to stroke.      This study is designed to investigate the tolerability and efficacy of a secondary stroke     prevention treatment with Aggrenox when initiated within 24 hours of stroke onset on a stroke     unit compared to later initiation after a 7 day ASA treatment and outside off a stroke unit     setting.   "
207849|NCT00562744|"     Patient simulation is a new and expanding technology that has proven effective as a teaching     tool in various clinical settings, but data on pediatric simulation is lacking. Mock     resuscitation scenarios have been shown in prior studies to be effective for improving     knowledge, skill, and confidence in pediatric housestaff. Our objective is to assess the     utility of a training program utilizing a human patient simulator of an infant as a teaching     tool for pediatric housestaff training in resuscitation skills. We hypothesize that mock     resuscitation exercises performed by pediatric housestaff on a patient simulator will result     in improved performance on test scenarios when compared to the same training on a standard     manikin.   "
207850|NCT00562757|"     The purpose of this study is to determine how well the device predicts susceptability to     potentially lethal ventricular arrhythmias.   "
207838|NCT00562601|"     This study will collect blood plasma and white blood cells from individuals using a procedure     called apheresis. Apheresis is a method of collecting larger quantities of certain blood     components than can safely be collected through a simple blood draw or blood donation     process. The blood components will be used in laboratory research studies to investigate     aspects of infectious and immunologic allergic diseases.      Patients 7 years of age and older who are currently enrolled in a NIH clinical research     protocol may participate in this study. (Children between the ages of 2 and 6 may participate     if they will benefit clinically from undergoing apheresis.) Family members of patients and     normal healthy volunteers will also be enrolled.        -  For all adults and children weighing 55 pounds or more. Blood is drawn through a needle          placed in an arm vein and circulated through a cell separator machine. The plasma and          white cells are extracted, and the red cells are returned to the donor through a needle          in the other arm. The procedure takes from 1 to 2 hours.        -  For children weighing less than 55 pounds. One unit (1 pint) of blood is drawn through a          needle placed in an arm vein, similar to donating a pint of whole blood. The red blood          cells are separated from the rest of the blood and returned to the donor through the          same needle. This procedure requires only one needlestick and takes about 30 to 45          minutes to complete. In some circumstances, the procedure must be repeated one or more          times in order to obtain large enough quantities of plasma or cells for study.   "
207839|NCT00562614|"     The purpose is to determine the effect of SLx-2101 dosed at 5mg or 10mg for 14 days on     systolic, diastolic pressures and heart rate in patients with hypertension.   "
207840|NCT00562627|"     Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain,     causing patient discomfort, mobilisation and hospital discharge.      The aim of this study is to:        1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee          arthroplasty.        2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural          analgesia.   "
207841|NCT00562640|"     RATIONALE: Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the     bone marrow to the blood so they can be collected. Treating stem cells collected from the     patient's blood in the laboratory may increase the number of immune cells that can mount an     immune response against the tumor. The treated stem cells may help destroy any remaining     tumor cells (graft-versus-tumor effect). Chemotherapy may also be given to the patient to     prepare the bone marrow for the stem cell transplant.      PURPOSE: This phase I trial is studying the side effects and best dose of autologous T cells     when given with or without cyclophosphamide and fludarabine in treating patients with     recurrent or persistent advanced ovarian epithelial cancer, primary peritoneal cavity cancer,     or fallopian tube cancer. (fludarabine treatment closed as of 12/012009)   "
207842|NCT00562653|"     The purpose is to evaluate autoantibodies in infective endocarditis patients before, at the     beginning of treatment, and after the end of the treatment, and to correlate the     autoantibodies in the presence of clinical symptoms.   "
207843|NCT00562666|"     For most patients with hepatocellular carcinoma, surgery or other curative procedures are not     possible and only palliative measures could be applied (chemoembolization, targeted drugs,     best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product     will be evaluated in patients in a palliative setting. All patients will have one hepatic     intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be     evaluated for safety.   "
207844|NCT00562679|"     The purpose of this study is to determine the effect of sleep apnea on mortality, stroke and     myocardial infarction among 408 patients with coronary artery disease referred for evaluation     of coronary intervention who were examined with overnight cardio respiratory monitoring     between March 1992 and June 1995.   "
207845|NCT00562692|"     Brain natriuretic peptide (BNP) is a useful therapy when treating patients with heart     failure. As many of these patients also have airways disease it is important to determine if     BNP also has a positive effect on their respiratory condition. The role of BNP in airways     disease has never been studied although there is evidence to suggest that it will have a     positive effect.      The current study is therefore a proof on concept study which will demonstrate whether BNP     (nesiritide) will improve both heart failure and airflow obstruction in patient who have     both.      The investigators are looking to enroll 40 patients with heart failure and airways disease     who present to hospital emergency departments. Patients who consent and meet the entry     criteria will be randomised to receive either nesiritide or placebo in addition to standard     therapy. They will receive a bolus of study medication followed by a 4 hour infusion. Before,     at hourly intervals and immediately following the infusion the following data will be     collected:        -  dyspnoea score        -  respiratory rate        -  FEV1 (if able to be performed)        -  peak respiratory flow rates (PEFR, if able to be performed)        -  requirement for concomitant bronchodilator therapy        -  urinary GMP At all times during the study period and at the conclusion of the study          patients will be provided with the best available therapy for their condition at the          physicians' discretion.   "
207846|NCT00562705|"     This is a two arm, randomized, prospective, intervention study in order to determine the     effects of growth hormone treatment on eating regulation and to compare between the growth     responses with or without nutritional intervention in short stature children.      The study will include 30 short stature children that are about to initiate growth hormone     treatment and will last for one year. After 4 months of treatment, children will be     randomized into two groups:        1. Control group that will continue with growth hormone treatment without any other          intervention.        2. Study group that will be a given a nutritional intervention in addition to growth          hormone treatment.      At screening visit and during the study the following parameters will be evaluated: height,     weight, growth markers in the blood and urine, child eating behavior questionnaire, blood     tests, hormonal tests and resting energy expenditure measurements.   "
207847|NCT00562718|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high energy x-rays to kill tumor cells. Capecitabine may also make     tumor cells more sensitive to radiation therapy. Giving radiation together with capecitabine     after surgery may kill any remaining tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving capecitabine     together with radiation therapy works in treating patients with nonmetastatic breast cancer.   "
207853|NCT00562796|"     Obesity is one of the leading causes of cardiovascular-related diseases, including diabetes     and heart disease. Obesity, and more specifically abdominal obesity, may cause decreased     growth hormone (GH) levels. It is believed that GH deficiency may contribute to increased     cardiovascular risk by affecting insulin resistance, inflammatory markers, and blood     cholesterol levels. This study will determine the occurrence of GH deficiency in abdominal     obesity and whether GH deficiency is associated with increased cardiovascular risk beyond     traditional risk factors.   "
207854|NCT00562809|"     The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and     300/25 mg in patients with hypertension not controlled by monotherapy.   "
207855|NCT00562822|"     The purpose of this study is to discover whether arthroscopic surgery is helpful in     controlling the symptoms of osteoarthritis of the knee.   "
207856|NCT00562835|"     Scientific background. Dysregulated systemic inflammation is a key pathogenetic mechanism for     morbidity and mortality in ALI/ARDS, and is associated with tissue insensitivity and/or     resistance to inappropriately elevated endogenous glucocorticoids. In one study, prolonged     methylprednisolone treatment of ARDS patients resulted in rapid and sustained reduction in     circulating and pulmonary levels of pro-inflammatory cytokines, chemokines, and procollagen.      Preliminary work. Five randomized trials (N = 518) investigating prolonged glucocorticoid     treatment in acute lung injury/ARDS reported a significant physiological improvement and a     sizable reduction in duration of mechanical ventilation and ICU length of stay. Insufficient     data is available on the effects of low dose prolonged methylprednisolone treatment initiated     in early ALI/ARDS on mortality.      Hypothesis. We hypothesized that the anti-inflammatory activity associated with prolonged     methylprednisolone administration improves pulmonary and extra-pulmonary organ dysfunction in     early ALI/ARDS and reduces mortality.      Objective. To investigate the effects of prolonged low-dose methylprednisolone infusion on     mortality and morbidity in early ALI/ARDS.      Study design. Multicenter, prospective randomized, placebo-controlled, double-blind clinical     trial.      Entry criteria. Patients with ALI/ARDS of less than 72 hours duration.      Stratification. Patients are prospectively stratified prior to randomization as (1) intubated     versus NPPV treated, and (2) ARDS versus severe ARDS. The purpose of stratification is to     distribute equally in both arms intubated versus NPPV treated, and ARDS versus severe ARDS.      End-points. The primary end-point of trial is 28 days all cause mortality; the secondary     end-points are (a) ventilator-free days at 28 days following study entry, (b) organ     failure-free days at 28 days following study entry, and (c) duration of ICU stay.   "
207857|NCT00568516|"     To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in     patients with prostate cancer   "
207858|NCT00568529|"     The purpose of this study is to evaluate the efficacy and overall survival of the regimen of     XELOX (Xeloda and oxaliplatin combination) in the patients with relapsed and refractory     gastric cancer.   "
207859|NCT00568542|"     The study is testing the hypothesis, that the application of low dose erythropoetin beta (35     I.E./kg BW/week) for 6 months following successful coronary revascularization by PCI improves     left ventricular remodeling as assessed by cardiac MRI.   "
207860|NCT00568555|"     Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of     Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural     pain-reducing systems. In this study, we will administer both LDN and placebo to a small     group of individuals with Fibromyalgia and Gulf War Syndrome, both Chronic Multisymptom     Illnesses, to assess the drug's efficacy in treating the condition.   "
207861|NCT00568568|"     The purpose og this study is to investigate the effects of growth hormon on insulin     signalling pathways and the temporal association between administration of GH and developing     of insulin resistance.   "
207862|NCT00568594|"     The purpose of this study is to determine: (1) the safety and pharmacokinetics of APL180     administered as a single intravenous infusion in healthy volunteers, and (2) the safety,     pharmacokinetics and pharmacodynamics of single and multiple daily intravenous infusions of     APL018 in patients with CHD   "
207863|NCT00568607|"     The purpose of this study is to evaluate the efficacy and tolerability of the combination     chemotherapy of DICE in the patients with NK/T cell lymphoma.   "
207864|NCT00568620|"     In parallel with the increasing prevalence of obesity worldwide, type 2 diabetes mellitus     (T2DM) has reached epidemic proportions. Despite a multitude of available therapies, only     bariatric surgery (e.g., roux-en-Y gastric bypass (GBP)) has proven to be an effective long     term treatment modality for morbid obesity. Moreover, the majority of T2DM patients who     undergo GBP experience normalization of their blood glucose and are able to discontinue their     anti-diabetes medications soon after the procedure. The insulin resistant state commonly seen     in non-diabetic obese subjects also improves after GBP. Evidence from recent animal studies     suggests that the rapid return to euglycemia seen in T2DM patients after GBP might in part     result from excluding the duodenum from the flow of nutrients. With the use of enteral     feeding tubes, we hope to better understand the factors in the human gut that may predispose     obese individuals to the development of insulin resistance and T2DM.   "
207865|NCT00568633|"     Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects older adults.     Even with the best chemotherapy, two-year disease-free survival is achieved in a minority of     patients. Bone marrow transplantation from a sibling donor may improve cure rates; however,     patients over 50 years of age have a high risk of complications and therefore generally are     excluded from this treatment option. Recently our group developed a transplantation strategy     for older cancer patients that protects against transplant-associated complications, yet does     not interfere with the ability of the transplanted donor cells to destroy cancer cells. With     this new method, we can now safely evaluate transplantation as a curative therapy for AML     patients over the age of 50. We have assembled clinical and scientific researchers throughout     the state of California to study and compare bone marrow transplantation using our new     approach with the best standard of care chemotherapy in AML patients over the age of 50. The     results of this study have the potential to establish a new treatment standard that will     improve survival of older AML patients.   "
207866|NCT00568646|"     To determine the antitumor activity of MKC-1 in patients with unresectable or metastatic     pancreatic cancer who have failed at least one prior chemotherapy regimen in either the     neoadjuvant, adjuvant, or first-line metastatic setting   "
207867|NCT00568659|"     The investigators aim is to study the specific lung elastance in ALI/ARDS patients during     invasive mechanical ventilation, in supine and prone position.   "
207868|NCT00568672|"     Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major     depression who had a response with additional olanzapine to an antidepressant.   "
207869|NCT00568685|"     The purpose of this study is to provide information regarding the relative effectiveness of     three different atomoxetine doses in the treatment of Korean children and adolescents with     Attention-Deficit/Hyperactivity Disorder (ADHD)   "
207870|NCT00568698|"     The objectives of this trial are: to establish a safety profile for use of Hydroxyurea in     children with Type I Spinal Muscular Atrophy; to identify reliable outcome measures for HU     treatment in Type I SMA; and to detect the clinical efficacy of HU treatment in children with     Type I SMA.   "
207871|NCT00568711|"     New antibiotics are required to have not only the antibacterial activity against     doxycyline-resistant O. tsutsugamushi but also lower risk for resistance or any     cross-resistance to others.      In this prospective, open-label, randomized trial, we enroll patients with mild-to-moderate     scrub typhus. We compared the efficacy and safety of a 5-day rifampin therapy with those of a     5-day doxycycline therapy at Chosun University Hospital, or one of its two community-based     affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.   "
207872|NCT00568724|"     The purpose of this study is to detect new urinary biomarkers that can be used as predictors     on renal function in congenital hydronephrosis caused by unilateral ureteral obstruction     (UUO) and to elucidate the pathophysiology of UUO.   "
207873|NCT00568737|"     Adult Patients with Severe Sepsis   "
207874|NCT00568750|"     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in     treating patients with gastrointestinal stromal tumors.   "
207875|NCT00568763|"     RATIONALE: Radiofrequency therapy and radiofrequency ablation use a high-frequency electric     current to kill tumor cells. Radiofrequency therapy can also cause the body to produce     heat-shock proteins which may help kill more tumor cells. Cryotherapy kills tumor cells by     freezing them. It is not yet known whether heat-shock proteins caused by radiofrequency     therapy given together with radiofrequency ablation or cryotherapy is more effective in     treating stage IV melanoma than radiofrequency therapy-induced heat-shock proteins alone.      PURPOSE: This randomized clinical trial is studying the side effects of radiofrequency     therapy-induced endogenous heat-shock proteins when given alone or together with     radiofrequency ablation or cryotherapy in treating patients with stage IV melanoma.   "
207876|NCT00568776|"     The purpose of this study is to evaluate the dose-related safety and efficacy of multiple     oral dosages of ELND005 as treatment for Alzheimer's disease (AD).   "
207877|NCT00568789|"     The purpose of this study is to investigate the effects of ramelteon in elderly subjects on     balance, mobility and memory impairment after awakening in the middle of the night following     bedtime dosing.   "
207878|NCT00568802|"     The objectives of this trial are: to establish a safety profile for use of Hydroxyurea in     children with Types II and III Spinal Muscular Atrophy; to identify reliable outcome measures     for HU treatment in Types II and III SMA; and to detect the clinical efficacy of HU treatment     in children with Types II and III SMA.   "
207879|NCT00568815|"     The purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with     ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse     large B cell lymphoma (DLBCL).   "
207880|NCT00568828|"     Earlier investigations have detected low levels of macular pigment (MP) in the center of the     fovea and a halo of MP at a higher eccentricity in persons with type 2 idiopathic juxtafoveal     teleangiectasia (MACTEL)[Helb H-M, Charbel Issa P, Pauleikhoff D, Scholl HPN, Holz FG,     MacTel-Study Group. Macular Pigment Density and Distribution in Patients with Macular     Telangiectasia. ARVO Annual Meeting 2006, Fort Lauderdale, 30.04.-5.05.2006. Program #     5701/B795]. To date it is not known whether the total MP is reduced in MACTEL or whether even     more MP accumulates at higher eccenticities compared to healthy probands. With the suggested     study we aim to        1. investigate Lutein and Zeaxanthin serum levels in MACTEL probands        2. investigate and quantify MP at the posterior pole of MACTEL probands        3. detect possible changes of MP concentration and distribution following supplementation          with Lutein and Zeaxanthin   "
207881|NCT00568841|"     This is a Phase-II Study to evaluate the accuracy of     Fluorodeoxyglucose-/Fluorothymidine-Positron Emission Tomography (FDG-/FLT-PET) analyses for     early prediction of non-progression in patients with non-small-cell lung cancer (NSCLC)     treated with Erlotinib.   "
207882|NCT00568854|"     The study hypothesis is that type 2 diabetics have abnormal cell-mediated immunity to     tuberculosis manifesting as altered cytokine responses by peripheral blood mononuclear cells     (PBMCs). This hypothesis will be tested using the live tuberculosis vaccine, Bacille     Calmette-Guerin (BCG), in U.S.-born type 2 diabetics and nondiabetics. The investigators will     control for potential confounding by age, sex, race, comorbidities, and select medications.     Expression of key cytokines will be measured with real-time polymerase chain reaction.   "
207883|NCT00568958|"     In this study, 140 heavy drinking young adults (aged 18-25) will be provided with brief     counseling and either naltrexone, a medication that is FDA-approved for the treatment of     alcohol dependence, or placebo over the course of 8 weeks. A novel strategy will be used for     administering low-dose naltrexone, in which daily dosing will be combined with targeted     dosing in anticipation of high-risk situations. The main hypotheses are that daily + targeted     naltrexone will result in greater reductions in frequency of heavy and any drinking compared     with daily + targeted placebo.   "
207884|NCT00568971|"     The purpose of this study is to evaluate the efficacy of weekly docetaxol combined with     cisplatin and 5-Fu in patients with AGC.   "
207885|NCT00568984|"     This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of     blood glucose control with combination therapy of repaglinide and metformin compared to     conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes   "
207886|NCT00568997|"     This study will examine the risk of systemic malignancies in pediatric patients with atopic     dermatitis exposed to Elidel 1% cream.   "
207887|NCT00569010|"     The goal of this clinical research study is to find the highest tolerable dose of Azacytidine     (5-azacytidine) combined with cytosine arabinoside (ara-C) for the treatment of patients with     relapsed and/or refractory Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome     (MDS). The safety and effectiveness of this treatment combination will also be studied.   "
207888|NCT00569023|"     To assess the effect of oral administration of the alga Dunaliella bardawil containing     approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers on visual     functions patients with Congenital Stationary Night Blindness {Fundus albipunctatus).   "
207889|NCT00569036|"     This is a Phase 1 dose escalation study to determine the safety, tolerability,     pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in     patients with advanced or metastatic solid tumors. In addition, the study is expected to     identify the recommended dose or dose range of BMS-754807 for Phase 2 studies   "
207890|NCT00569049|"     This is a research-based study that is looking at the biologic features of breast tissue,     lymph node tissue, or blood in order to study breast cancer development growth, and spread.     Through tissue and/or blood samples we hope to gain further knowledge and understanding of     how to improve diagnosis and treatment of breast cancer by identifying the molecular markers     that predict clinical outcome and response to therapy.   "
207891|NCT00569062|"     GW856553 is a novel compound, currently in development for the treatment of Major Depressive     Disorder (MDD), and other indications. GW856553 inhibits a protein which is responsible for     the production of some pro-inflammatory molecules, called cytokines. Increased blood levels     of these molecules were seen in populations of MDD patients and this was more apparent in     subjects with severe symptoms, psychomotor retardation and loss of energy. Aim of the present     study is to assess whether GW856553, by inactivating this protein, is able to suppress the     production of the cytokines, and ultimately relieving depression symptoms. In this study     GW856553 or placebo is given to MDD patients 7.5md twice daily for 6 weeks.   "
207892|NCT00569075|"     The goal of this study is to facilitate early diagnosis of gum disease. Proteins associated     with cell death will be isolated from gum pockets of diseased and healthy patients and     evaluated.   "
207893|NCT00569088|"     The purpose of this study is to determine whether the Chinese herbs formula is effective in     the treatment of hemorrhagic stroke and to find out Chinese pathogeny and pathogenesis in the     disease.   "
207894|NCT00569101|"     The purpose of this protocol is to determine whether Tacrolimus and Prednisolone are     effective and safe in the treatment of the cyclophosphamide-resistant, refractory diffuse     proliferative lupus nephritis   "
207895|NCT00569114|"     This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to     determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell     Lung Cancer in combination with erlotinib.   "
207896|NCT00569127|"     This randomized phase III trial is studying giving octreotide acetate together with     recombinant interferon alfa-2b to see how well it works compared with giving octreotide     acetate together with bevacizumab in treating patients with metastatic or locally advanced,     high-risk neuroendocrine tumor. Octreotide acetate and recombinant interferon alfa-2b may     interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. It is not yet known whether giving octreotide acetate     together with recombinant interferon alfa-2b is more effective than giving octreotide acetate     together with bevacizumab in treating patients with neuroendocrine tumor.   "
207897|NCT00569140|"     The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic     profile of E10030 intravitreous injection when administered as monotherapy or in combination     with Lucentis® 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary     to age-related macular degeneration (AMD).   "
207898|NCT00569153|"     The purpose of this study is to determine the safety and tolerability of TAK-700 in patients     with asymptomatic metastatic, androgen independent prostate cancer.   "
207899|NCT00569166|"     RATIONALE: Paced breathing may be an effective way to reduce the number and severity of hot     flashes in women who have survived breast cancer.      PURPOSE: This randomized phase II trial is comparing three different programs of paced     breathing to see how well they work in treating hot flashes in women.   "
207900|NCT00569179|"     The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells     that can be transfused following stem cell transplant.   "
207901|NCT00569192|"     The purpose of this study is to examine the safety and efficacy of two doses of MAP0010     versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week     treatment period.   "
207902|NCT00569231|"     The purpose of this study is to look at how people respond to the treatment of warts through     use of the Candida antigen to get an immune response to rid the body of human papillomavirus     (HPV). The immune system is the part of the body that fights infections like HPV which causes     warts. This research study will examine the response of your wart when injected with a     portion of a common yeast (candida) which is the study drug. Your immune system response will     also be looked at by doing a test called an ELISPOT assay. This test is done on blood     samples. The results of this test may help us to determine how the Candida antigen affects     your wart.   "
207903|NCT00569244|"     The investigational drug SH T00186D is an oral contraceptive. The investigational drug used     in this study contains the estrogen ethinylestradiol (EE) and the progestogen drospirenone     (DRSP).      The aim of the present study is to evaluate efficacy and safety of the investigational drug     in the treatment of menstrual pain (pelvic pain occurring shortly before, at onset, during     menstruation). Two different regimens of intake of the same investigational product will be     compared.      Patients have to undergo 2 -3 Baseline cycles (depending on whether the patient was an OC     user before), during which menstrual pain, bleeding events, and pain killer intake have to be     documented. During this observation period, the intake of hormonal contraceptives is not     allowed. Other contraceptive methods (condoms with spermicide, pessary with spermicide) have     to be used. If the patient is eligible for the study, she will be randomly assigned to one of     the two treatment groups. Treatment group A will take the medication according to an extended     flexible regimen, i.e., tablet intake will be triggered by bleeding events. Treatment group B     will take the study medication in the 24 + 4 days regimen. That means, tablets to be taken on     cycle days 1 - 24 contain the hormone combination, whereas tablets 25 - 28 do not contain any     active ingredients, i.e., these are so called placebo tablets.      Treatment will last at least 140 days, but can be prolonged in Treatment Group A depending of     occurrence of menstrual bleeding. The overall study duration will be 10 months for each     patient.      During the whole study period, 5 visits are planned. At Screening and Final examination, a     thorough physical examination and a gynecological examination (including breath palpation and     cervical smear ) will be performed. Blood samples will be taken for safety laboratory     parameters.      Additional examinations can be performed any time, if this becomes necessary for medical     reasons.      Patients will be provided with a patient diary to document the intake of study medication,     any bleeding events and days without bleeding, pregnancy test results, any dysmenorrheic     (menstrual) pain and its intensity and its interference with daily activity, and intake of     pain medication. The pain medication (ibuprofen) will be provided.   "
207904|NCT00569257|"     The purpose of this study is to determine whether AEZS-108 shows anti-tumor activity and is     tolerated in patients with gynecological tumors (ovarian / endometrial cancer) that have been     shown to express receptors for the luteinizing hormone releasing hormone (LHRH)   "
207905|NCT00569270|"     We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease)     patients with moderately severe disease using metronome paced hyperventilation (MPH) with     inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung     volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized     crossover double blinded study.   "
207906|NCT00569283|"     RATIONALE: Giving donor natural killer cells to patients who have undergone donor bone marrow     transplant may make the transplant work better and keep cancer cells from coming back.      PURPOSE: This phase I trial is studying the side effects and best dose of donor natural kill     cells in preventing relapse or graft failure in patients who have undergone donor bone marrow     transplant.   "
207907|NCT00569296|"     RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with     antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the     lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the     number of immune cells found in bone marrow or peripheral blood. Giving laboratory-treated     autologous lymphocytes together with aldesleukin and GM-CSF may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated     autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients     with recurrent, refractory, or metastatic non-small cell lung cancer.      FUNDING SOURCE--FDA OOPD   "
207908|NCT00569309|"     RATIONALE: Vaccines may help the body build an effective immune response to kill cancer     cells. Giving vaccine therapy after an autologous stem cell transplant may kill any cancer     cells that remain after transplant.      PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients     who have undergone autologous stem cell transplant for high-risk lymphoma or multiple     myeloma.   "
207909|NCT00569322|"     Determine if routine BG testing at the time of ICU admission is being done on all patients,     irrespective of a prior diagnosis of diabetes mellitus, and whether it provides clinically     important information.   "
207910|NCT00569335|"     Phase II trial of combination therapy with S-1, irinotecan, and bevacizumab (SIRB) in     patients with unresectable or recurrent colorectal cancer   "
207911|NCT00569361|"     Using a human pangenomic microarray, the researchers established expression profiles of nasal     epithelial cells, collected by brushing of patients belonging to one of four distinct groups:        1. allergic rhinitis to dust mite (AR) isolated (n=12),        2. AR associated with bronchial hyperreactivity (n=12),        3. AR associated with asthma (n=14),        4. control (n=14).   "
207912|NCT00569374|"     This 7 week, open-label pilot clinical trial will examine the safety and tolerability of     modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in     methamphetamine-dependent volunteers.   "
207913|NCT00569387|"     To assess the response for subjects with pancreatic cancer that have undergone surgical     resection and treatment with a vaccine given with chemotherapy and chemoradiation.   "
207914|NCT00569400|"     This trial is conducted in Asia and Oceania. The aim of this trial is to compare the efficacy     and safety of human insulin produced by the current process and the NN729 process in type 1     diabetes.   "
207915|NCT00569413|"     The current study combines a molecular genetic perspective, self report and brain imaging to     the study of human sexuality in control subjects and individuals from a sexual disorder     clinic. The investigators hypothesize that the variability in components of the brain     dopaminergic system expressed in the mesolimbic reward system can explain variability in     human sexuality, especially in desire and pleasure associated with sex.   "
207916|NCT00569426|"     This trial is conducted in Europe. The aim of this trial is to compare two needle types when     used with a disposable insulin injection pen in the everyday life setting of an insulin     treated patient with diabetes.   "
207917|NCT00569439|"     The purpose is to determine in term nulliparas with singletons that present in active labor     (3-5 cm) or with ruptured membranes whether the administration of dextrose solutions to     normal saline improves or expedites the course of labor. The researchers' hypothesis is that     the addition of a carbohydrate substrate will shorten the length of labor and facilitate a     vaginal delivery.   "
207918|NCT00569452|"     This is a pilot trial to establish study procedures that allow comparison of various starting     basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control     achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant     basal rate (flat profile) will be compared during a composite fasting day as well as     therapeutic success after 2 weeks of normal activity.   "
207919|NCT00569465|"     It has been demonstrated that the nitric oxide production is reduced in type 2 diabetic     patients and that cardiovascular complications represent 80% of the causes of death in these     patients. As nitric oxide is able to reduce platelet aggregation, increase the relaxation of     smooth muscle cells, and reduce plasminogen activator inhibitor-1 and endothelin, we     hypothesized that nitric oxide deficiency is responsable for the cardiovascular disease in     type 2 diabetes mellitus. Arginine and N-acetylcysteine, precursor and enhancer of the nitric     oxide synthesis respectively, are able to increase nitric oxide production.      Aim of the study is to evaluate the effect of arginine and N-acetylcysteine administration on     arterial blood pressure and different metabolic parameters in patients with type 2 diabetes     mellitus and hypertension.      Subjects and methods. 24 male subjects, randomly divided in two groups, will be studied.     These subjects will undergo a treatment with arginine (1200 mg once a day) plus     N-acetylcysteine (600 mg twice a day) or placebo for six months. Basal and final evaluations     include:        -  general examination        -  ABPM (ambulatory blood pressure monitoring)        -  HbA1c, total-cholesterol, HDL-cholesterol, LDL-cholesterol, oxidized LDLs,          triglycerides, reduced/oxidized glutathione ratio in red blood cells, nitrites/nitrates,          asymmetrical and symmetrical dimethyl-arginine, nitrotyrosine, arginine, homocysteine,          C-reactive protein, interleukin-6, tumor necrosis factor-α, intercellular and          vascular-cell adhesion molecules, plasminogen activator inhibitor-1 and fibrinogen        -  the ultrasound assessment of the intima-media thickness after endothelium-dependent          flow-mediated vasodilation of the brachial artery      Expected results. Increase of nitric oxide production and reduction of arterial blood     pressure and oxidative parameters.   "
207920|NCT00569478|"     The purpose of this study is to describe the effect and meaning of an outpatient-nursing     programme including physical activity for patients with implantable cardioverter     defibrillators (ICD).      Hypothesis: The outpatient nursing programme will increase the perceived health and quality     of life; improve the management of life from a patient perspective; reduce fear of exercise     and increase physical capability and reduce the number of treatment-demanding arrhythmias.   "
207921|NCT00569491|"     The TAXUS ARRIVE study is a multi-center safety and surveillance study designed to to compile     safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting     Coronary Stent System in routine clinical practice and to identify low frequency TAXUS     related clinical events.   "
207923|NCT00569517|"     The purpose of this pilot study is to assess patient accessibility, interest and response in     order to design an adequately powered study to compare brief, group cognitive behavioral     therapy (CBT) for weight loss to usual care in non-demented patients above the age of 18     years old who are currently taking atypical antipsychotic medications. This pilot study is     necessary, with current limitations of data in this area, to design an adequately powered     study to address the difficulties managing metabolic syndrome risk factors in patients on     antipsychotics.   "
207924|NCT00569530|"     The purpose of this study is to determine if the combination of late doses of Infasurf with     inhaled nitric oxide will interact to improve the surfactant function and thus the     respiratory status and outcome of treated infants.   "
207925|NCT00569543|"     RATIONALE: Studying samples of urine in the laboratory from women with breast cancer may help     doctors learn whether tamoxifen and aromatase inhibitors alter the metabolism of estrogens.      PURPOSE: This clinical trial is studying the effect of tamoxifen or an aromatase inhibitor on     estrogen metabolism in women undergoing treatment for newly diagnosed breast cancer.   "
207926|NCT00569556|"     The purpose of the study is to determine if a nurse managed, protocol driven, disease     management process for diabetes results in improved attainment of therapeutic goals for     diabetes compared to usual care. It is hypothesized that implementation of the disease     management process will improve the percentage of diabetic individuals attaining all three     therapeutic targets (HgbA1C<8.0%, LDL<100mg/dl, and BP<130/80mmHG) by 10% compared to usual     care.   "
207927|NCT00569569|"     The treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral     activity in age related macular degeneration currently presents a great challenge. With     visual loss threatening, there are only very few therapeutic options.      While these patients are neither suitable for laser therapy nor for photodynamic therapy with     Verteporfin, antiangiogenic drugs applied intravitreally are now available.      Some patients however reject this therapeutic option because of potential complications such     as endophthalmitis and the frequency of necessary injections. 20 patients who rejected     intravitreal therapy were treated with Anecortave acetate (Retaane®) which was applied as a     juxtascleral depot injection.   "
207928|NCT00569582|"     Patients will receive Corlux (mifepristone) daily for up to 24 weeks. Assessments of the     signs and symptoms of Cushing's syndrome will be obtained.   "
207929|NCT00569595|"     Poor diet, physical inactivity, and sedentary behaviors among low-income, minority     populations have been linked to greater risk of chronic health conditions such as     overweight/obesity, cardiovascular disease, and type 2 diabetes. Low-income clinics that     serve these populations often represent an untapped opportunity for health promotion in     impoverished individuals. This exploratory project proposes to address this scientific gap by     introducing and conducting a randomized controlled pilot of the Self-Care Stimulating Disease     Prevention Program to address poor dietary habits, physical inactivity, and sedentary     lifestyle behaviors among low income, uninsured patient populations.   "
207930|NCT00569608|"     Early discharge of premature infants from the Neonatal Intensive Care Unit will have     substantial benefits:      (i) diminish parental stress;      (ii) increase parental - child bonding;      (iii) diminish medical complications derived from prolonged hospitalization;      (iv) reduce cost;      (v) increase number of point of attendance disponible for future patients.   "
207931|NCT00569621|"     It is known that several common eye diseases are associated with ocular perfusion     abnormalities. Moxaverine is used in the therapy of perfusion abnormalities in the brain, the     heart and the extremities because of its direct vasodilatory effects. The present study     seeked to investigate whether moxaverine alters ocular blood flow in healthy volunteers after     intravenous administration.   "
207932|NCT00569634|"     The purpose of this study is to examine the agreement between venous blood gas and arterial     blood gas measurements in patients in the Intensive Care Unit.   "
207933|NCT00569647|"     Children with burns often require repeated reconstructive surgeries. These children tend to     develop high levels of anxiety before coming to the operating room. Preoperative sedation,     while somewhat effective in relieving this anxiety, has a number of side effects. The     researchers hypothesized that preoperative anxiety could be effectively reduced by the     utilization of a device which induces a relaxing hypnotic state through emmersion in a     virtual reality environment.   "
207934|NCT00569660|"     The goal of this clinical research study is to learn if azacitidine can help to control MF.     The safety of azacitidine in patients with Myelofibrosis (MF) will also be studied.   "
207935|NCT00569673|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune     system recover from the side effects of chemotherapy. Giving combination chemotherapy     together with G-CSF or pegfilgrastim may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and     trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or     persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity     cancer.   "
207936|NCT00569686|"     Sixty patients with mild-to-moderate PAD (ABI 0.4-0.9) and hypertriglyceridemia (>200 mg/dl)     already treated with statins will be imaged at baseline and randomized to Lovaza and placebo     for 12 months. MR imaging will be repeated at the end of the 12-month period.      We hypothesize that treatment of hypertriglyceridemia in patients with PAD with Lovaza will     reduce atherosclerotic plaque volume in the superficial femoral artery (SFA) by 2% over 1     year compared to placebo. Secondary aims will be to show improved plaque characteristics     (thickened fibrous cap, reduced lipid-rich necrotic core, improved exercise calf muscle     perfusion using first-pass contrast enhanced MRI and improved exercise treadmill performance     with Lovaza compared to matching placebo.   "
207937|NCT00569699|"     The purpose of this study is to determine whether S-1 and bevacizumab are safe in the     treatment of unresectable or recurrent colorectal cancer   "
208004|NCT00570622|"     The purpose of this study is to investigate the response to pioglitazone on the hepatic     venous pressure gradient and peripheral vascular responsiveness to vasoconstrictors in     patients with advanced (Child´s Grade B or C) cirrhosis.   "
251381|NCT01146522|"     This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients     with severe hypertriglyceridemia.   "
207938|NCT00569712|"     RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory     from patients receiving budesonide and formoterol may help doctors learn more about the     effect of budesonide and formoterol on gene expression and biomarkers.      PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients     with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung     cancer, or with asthma treated with budesonide and formoterol.   "
207939|NCT00569738|"     Imaging of neuroendocrine tumors (NETs) relies on conventional morphological methods and on     somatostatin receptor scintigraphy (SRS). SRS is effective for carcinoid tumors, and for most     pancreatic islet-cell tumors, but may fail to detect some tumors. Furthermore, this technique     may require repeated imaging over 24-48 hours. Introduction of newer somatostatin analogs     such as DOTANOC improves lesion detection. In addition, labeling with Ga68 and use of PET/CT     improves the pharmacokinetics of the tracer resulting in better tumor visualization, and an     easier procedure with imaging over only 1-2 hours.      In this study, we propose to use Ga68-DOTANOC PET for imaging of various NETs, comparing the     imaging data to those of anatomical and other functional modalities, and to histopathology,     when available.   "
207940|NCT00569751|"     The TAXUS ARRIVE 2 study is a multi-center safety and surveillance study designed to to     compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™     Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low     frequency TAXUS related clinical events.   "
207941|NCT00569764|"     To measure the long-term changes in weight and plasma lipids after switching antipsychotic     treatment to aripiprazole   "
207942|NCT00569777|"     The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal     volunteers   "
207943|NCT00569790|"     The purpose of this study is to determine whether irinotecan, S-1, and bevacizumab are safe     in the treatment of unresectable or recurrent colorectal cancer   "
207944|NCT00569803|"     Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept     Administered Subcutaneously to Healthy Subjects   "
207945|NCT00569816|"     Pharmacologic preconditioning by volatile anesthetics may depend on the mode of     administration. The researchers hypothesize that a continuous administration in patients     scheduled for CABG surgery prebypass will be less effective in terms of attenuating     myocardial cell damage compared to a repetitive administration with a double wash in/wash out     schedule. A control group will receive propofol as their primary anesthetic.   "
207946|NCT00569829|"     Although cognitive behavioral therapy (CBT) has been found to be efficacious in the treatment     of child anxiety disorders, little progress has been made in the dissemination of such     treatments to real-world practice settings. Clinical trials conducted in practice settings     can demonstrate the degree to which evidence-based treatments are appropriate for larger     scale dissemination. This study evaluates CBT as a treatment for child anxiety disorders in     the elementary school clinic setting. A randomized, controlled trial design has been     employed, comparing immediate treatment and a three-month waitlist. The trial is being     conducted in several Los Angeles area elementary schools and is only available to children in     these particular schools. To ensure that the CBT intervention is flexible and capable of     matching the characteristics of various school settings, clinicians, and referred children, a     modular treatment approach is employed. The study design includes elements to ensure high     quality data, such as the use of independent evaluators and tests of treatment fidelity.     Children, ages 5 to 12 years, are referred by teachers and staff or are identified as having     high anxiety in concurrent studies. All participating children have DSM-IV diagnoses of     separation anxiety disorder, generalized anxiety disorder, or social phobia, according to a     semi-structured diagnostic interview. Therapy and clinical supervision is provided by the     research team. It is hypothesized that children receiving immediate treatment will have     significantly lower anxiety scores than children assigned to the waitlist at the     posttreatment/postwaitlist assessment. If results are favorable, further exploration of     dissemination of CBT into school clinic settings may be indicated.   "
207947|NCT00569842|"     Currently, there is no accurate way of predicting the occurrence of Graft vs Host Disease     (GvHD) or infection. The purpose of this study is to analyze blood with the ImmuKnow® Assay     to see if doctors can detect which patients are at risk for GvHD and for getting an infection     before they occur.   "
207948|NCT00569855|"     Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs     during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine     is safe. This drug lowers the blood pressure, making it easier for the cardiopulmonary bypass     machine to deliver blood and oxygen to all of the organs and tissues.   "
207949|NCT00569868|"     To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple     myeloma participants undergoing VELCADE treatment for the first time.   "
207950|NCT00569881|"     The prescribed antibiotic for prophylaxis of infection following PRK should be effective at     eradicating a potential infection. In addition, the antibiotic should have a rapid onset of     action, effectively penetrate the target tissue, and be safe and not toxic to any layer of     the healing cornea, especially the epithelium. Several studies have investigated the toxicity     of the fourth generation fluoroquinolones on the corneal epithelium and studies have     demonstrated that gatifloxacin is less deleterious to the healing cornea than moxifloxacin.     Most of these studies, however, have been conducted in animals. This was a retrospective     chart review.   "
207951|NCT00569894|"     To assess the safety of FluMist vaccination   "
207963|NCT00570050|"     The primary aim of the study is to determine whether adjunctive intranasal insulin will exert     an antidepressant effect when compared to placebo in adults with major depressive disorder     (MDD), insufficiently responsive conventional antidepressants. There are three secondary aims     of the study (1) to determine whether adjunctive intranasal insulin will alter emotional     processing (i.e., cognitive-affective interface); (2) to determine whether early changes in     emotional processing (i.e., after a single dose at 40IU intranasal insulin) predicts     symptomatic improvement at study endpoint; and (3) to determine the effect of intranasal     insulin on neurocognitive performance (e.g., learning and memory). This initiative represents     a proof-of-concept study that insulin is important to depressive symptoms, neurocognitive     functioning, and emotional processing deficits in MDD, representing a novel and safe     therapeutic avenue.   "
207952|NCT00569907|"     Approximately 30 adults will participate in this study at the International Diabetes Center     (IDC). The IDC is the only site conducting this study.      Length of participation can range from two to three months which will include four to seven     clinic visits.      The purpose of this study is to use a Continuous Glucose Monitoring (CGM) system to determine     the characteristics of glucose control and patterns of food intake before exenatide is     started, during the start and adjustment of exenatide and during exenatide treatment.      The long-term purpose of this study is to determine to what extent continuous glucose     monitoring improves or alters clinical decision making for patients treated with exenatide.     And, the study will also compare CGM to conventional self-monitored blood glucose methods.      The study will also compare subjects' changes, if any, in nutrient intake such as energy,     protein, fat and carbohydrate during the course of the study through interpretation/analysis     of self-reported food intake.   "
207953|NCT00569920|"     Postoperative pain and nausea may diminish a patient`s wellbeing, and may also delay     rehabilitation, as well as increase the total cost of care and treatment. Opioids are     effective drugs for treatment of pain, but with the disadvantage of side effects such as     somnolence and nausea. The benefits of various types of non-opioid analgesic in reducing     patients` postoperative need for opioids have been well-documented.      One non-opioid prophylaxis documented for various surgery is short-term treatment with     corticosteroids. The optimal dose of corticosteroids for peroperative nausea and pain     prophylaxis is not well-documented. In our study we will attempt to determine whether the     aforementioned benefits of corticosteroids are valid for a group of patients undergoing     thyroid surgery.      Hypothesis: Single-dose treatment with dexamethasone provides a better analgesic effect     and/or reduced use of opioids than placebo in patients undergoing elective throid surgery.     Higher dose of dexamethasone provide better and/or longer-lasting analgesic effects without     influencing the side effect profile.   "
207954|NCT00569933|"     Use of audio recordings (with suggestions and imagery for a better surgical outcome) studied     in orthopedic patients.   "
207955|NCT00569946|"     To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)   "
207956|NCT00569959|"     This study will examine whether fasting and non-fasting lipid measures can provide similar     clinical information in order to guide lipid management by primary physicians. It will     compare fasting vs. non-fasting lipid measurements in patients with and without diabetes.   "
207957|NCT00569972|"     To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on     subjective wake after sleep onset in subjects with primary insomnia.   "
207958|NCT00569985|"     This pilot clinical trial studies biological therapy in treating patients with acquired     immune deficiency syndrome (AIDS)-related lymphoma undergoing stem cell transplant. Giving     chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them     from dividing or killing them. After treatment, stem cells are collected from the patient's     blood and stored. The stem cells are then returned to the patient to replace the     blood-forming cells that were destroyed by the chemotherapy. Giving biological therapy as     part of the stem cell transplant may be more effective in treating patients with AIDS-related     lymphoma   "
207959|NCT00569998|"     This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery     pens in the everyday life setting of patients with diabetes treated with insulin.   "
207960|NCT00570011|"     An international study in which patients with GHD were randomized to receive somatropin at a     dose of either 3 microg/kg/day or 6 microg/kg/day for the first three months. The dose was     then doubled (6 microg/kg/day, LD or 12 microg/kg/day, CD) for the next three-months.   "
207961|NCT00570024|"     This research is being done because sudden and unexpected cardiac death remains a significant     problem in patients with established coronary heart disease and accounts for 30% of deaths in     this group (150,000 deaths annually) despite recognition and treatment of their heart     disease. A large body of evidence implicates psychosocial stress as a risk factor and trigger     for reduced blood flow in the heart, heart attack and sudden cardiac death, yet the specific     mechanisms of this relationship remain under investigation. The nervous system, which plays a     role in regulation of the heart, can influence cardiac arrhythmias (irregular heart beats).     There are several studies that suggest that acupuncture improves anginal symptoms (like chest     pain or tightness) and blood pressure, while reducing stress and improving overall quality of     life. The reason that acupuncture seems to have a positive effect on these factors is thought     to be that it helps the arteries and the nervous system to work better.      It is possible to measure these effects in a systematic way. The functioning of the artery     can be measured by Peripheral Arterial Tonometry, (PAT) a simple monitoring device that     measures blood flow using finger probes and a blood pressure cuff. Changes in the nervous     system can be measured by using a 24-hour Holter monitor to record the heart rate. The     24-hour Holter monitor will also show if oxygen flow to the heart is decreased, as would     happen during stress, by recording a continuous electrocardiogram (ECG). Feelings about     stress can be established by questionnaires.      The purpose of this study is to compare three groups of people with known coronary heart     disease. One group will receive traditional acupuncture, one group will receive alternative     acupuncture, and a third group will receive usual care only.   "
207962|NCT00570037|"     Influenza causes epidemics of respiratory infection in young children each winter. Young     children, particularly those under 6 months of age are most vulnerable to suffering from     complications secondary to influenza infection. Consequently, influenza vaccine has been     recommended for children 6-59 months of age. Influenza vaccine is not approved for use in     children under 6 month of age who are at highest risk. Therefore, the Centers for Disease     Control and Prevention Advisory Committee on Immunization Practices has recommended     vaccination of household contacts of children under 6 month of age - a cocooning strategy.      The current study is a hospital-based study to assess the effectiveness of a program to     vaccinate birth mothers and household contacts of newborns with influenza vaccine. We propose     to study both birth mothers and household contacts of newborns delivered at Durham Regional     Hospital and Duke University Medical Center, birthing hospitals serving Durham and     surrounding counties in central North Carolina. We will implement several strategies to     increase vaccine coverage rates at Durham Regional Hospital utilizing Duke University     Hospital as a comparison setting. Strategies will include: standing vaccine orders for birth     mothers, vaccine reminders for household contacts, and a hospital based influenza vaccine     clinic to increase vaccine accessibility for household contacts. Vaccine coverage rates will     be assessed utilizing a survey method (maternal interview at the birthing hospital and a     follow-up telephone contact 6-8 weeks later). We hypothesize that influenza vaccine coverage     rates for new mothers and household contacts of newborns delivered at the intervention     hospital will be higher when compared to coverage rates in the comparison hospital.     Demographic determinants of vaccine coverage and reasons for refusal of influenza vaccine     will also be assessed.   "
208297|NCT00575471|"     The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the     change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.   "
207965|NCT00570089|"     1. To evaluate the impact of ranolazine extended-release tablets in women with          subendocardial ischemia due to microvascular endothelial dysfunction on myocardial          ischemia (Cardiac Magnetic Resonance (CMR) extent, severity.        2. To evaluate the impact of ranolazine extended-release tablets in women with          subendocardial ischemia due to microvascular endothelial dysfunction on the outcomes of          angina (Seattle Angina Questionnaire (SAQ), WISE angina frequency, Duke Activity Status          Inventory(DASI) and SF-36).   "
207966|NCT00570102|"     The overall objective of the study is to assess whether complete avoidance of cow's milk (CM)     proteins, for at least the first 6 months of life, prevents type 1 diabetes     (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a     mother, biological father or sibling affected by type 1 diabetes.   "
207967|NCT00570115|"     The purpose of this study is to determine whether patients with obstructive sleep apnea have     any changes in left atrial morphology and function evaluated by echocardiography three     dimensional   "
207968|NCT00570128|"     The purpose of this study is to determine whether donepezil HCl is effective and safe in     improving cognitive dysfunction exhibited by children and adolescents with Down syndrome.     Effectiveness will be measured by rating communication, daily living skills, and social     skills and relationships in subjects aged 10 to 17.   "
207969|NCT00570141|"     OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing     wounds to explore the mechanism of action.   "
207970|NCT00570154|"     Background:      Patients who are pre-diabetic or have adult onset (type 2) diabetes have a significantly     greater risk of developing heart, blood vessel, or kidney diseases.      Recent studies have shown that abnormalities in white blood cell function may increase the     chances of developing insulin resistance, the underlying problem in diabetic or pre-diabetic     patients.      Objectives:      To determine levels of insulin sensitivity in selected volunteers.      To compare the white blood cells of non-diabetic, pre-diabetic, and type 2 (adult onset)     diabetic volunteers to evaluate possible differences in white blood cell function.      Eligibility:      Individuals between 21 and 60 years of age who (1) are non-diabetic, (2) are pre-diabetic     (glucose intolerant or insulin resistant), or (3) have type 2 diabetes that is controlled by     diet and/or medications other than insulin.      Design:      Evaluations before treatment:        -  Blood tests, including screening procedures for blood-transmitted diseases such as          hepatitis B and C, insulin sensitivity and glucose tolerance tests, and liver and kidney          function tests.        -  Pregnancy tests for women of childbearing age.      Two tests will be performed during the study period:        -  Glucose tolerance test to determine how well the body uses glucose.        -  Blood drawn to study white blood cells.      Participants will be financially compensated for the time spent during the study.   "
207971|NCT00570167|"     To compare clinical, functional and radiological outcome after hip resurfacing and cementless     metal-on-metal total hip arthroplasty.   "
207972|NCT00570180|"     Given the disappointing results with routine ASCT in t(4;14) patients, we propose this open     label phase II study of bortezomib along with dexamethasone and pegylated liposomal     doxorubicin (Doxil/Caelyx), referred to as the DBd regimen, for 4 cycles, followed by     post-induction therapy with cyclophosphamide + bortezomib + prednisone (referred to as the     CyBorP regimen) for 8 cycles. Since patients with t(4;14) remain at high risk for relapse,     maintenance therapy with dexamethasone weekly will be given until disease progression.   "
207973|NCT00570193|"     The goal of this pilot study is to validate the use of the combination of Lucentis     (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization     (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a     volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and     as a tool for determining the need for retreatment.   "
207974|NCT00570206|"     The purpose of this study is to examine the effects of Motivational Interviewing (MI) on     probationer progress over a 6-month period, using probation officers as the MI providers.   "
207975|NCT00570219|"     The aim of this study is to determine whether valproate is effective in the treatment of     benzodiazepine withdrawal symptoms in subjects receiving maintenance treatment for opiate     dependence.   "
207976|NCT00570232|"     The purpose of this study is to determine whether erlotinib will be effective in controlling     cancer that has returned after treatment with salvage surgery and radiation. This study will     also determine what effects, good and/or bad, this drug has on the participants.   "
207977|NCT00570245|"     The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide in     prevention of lung graft dysfunction due to ischemia-reperfusion   "
207978|NCT00570258|"     This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus     fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progression     after first line hormonal therapy.        1. To obtain preliminary estimates of the magnitude and variability of the efficacy of          fulvestrant in combination with erlotinib in this subject population, and        2. To obtain historically up-to-date estimates of the magnitude and variability of the          efficacy of fulvestrant as the sole active agent in this subject population.      The measure of efficacy for both primary objectives will be time to progression.   "
207979|NCT00570271|"     A relevant reduction of blood pressure (BP) in placebo-treated control groups is a phenomenon     often observed in pharmacological studies of hypertension. This effect was shown to differ     from spontaneous remission tendencies and regression to the mean effect by comparing placebo     groups with untreated controls. However, it is not fully understood whether these effects are     due to a global reaction of the autonomous nervous system (affecting the overall organ     systems of the body) or a specific reaction (affecting the cardiovascular system only). We     therefore aim to differentiate specific effects (reduction of blood pressure) from global     effects (e.g. changes in electrodermal and gastric activity).      In our study we aim to test the following hypotheses:        1. Placebo administration leads to a significant changes of blood pressure compared with          untreated controls.        2. The direction of blood pressure change depends on the type of suggestion (either          decrease or increase)        3. This effect is specific for blood pressure; changes in electrodermal and gastric          activity do not differ between groups.        4. The placebo response can be enhanced by a prestige intervention (information about the          suggested drug action given by doctor or in written form).   "
207981|NCT00570297|"     Bronchiolitis is a significant cause of morbidity and hospitalization in children, accounting     for approximately 125,000 hospitalizations per year in the U.S. Recently, genetic variations     of the β2-adrenergic receptor (β2-AR) have been shown to influence response to β2-AR agonist     therapy in children with asthma. We suspect that genetic variations of the β2-AR also affect     response to β2-AR agonist therapy in children with bronchiolitis.   "
207982|NCT00570310|"     The purpose of this study is to determine the best way to conduct clinical trials in patients     with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect     on neuropathic pain.   "
207983|NCT00570323|"     Over the last 3 decades, a steady shift has occurred in the management of breast cancer.     Because it was traditionally viewed as a local disease, many advocated the use of radical     surgery to achieve maximum survival benefit. This view has been slowly replaced by a broader     biologic view that recognizes the often systemic nature of breast cancer, even when it     appears to be localized to the breast. Results from randomized clinical trials have     demonstrated that less extensive surgery, or lumpectomy plus radiation therapy, are optimal     for local management of early breast cancer. In addition to the less radical approach to     surgical treatment of breast cancer, other randomized clinical trials have established the     value of postoperative systemic therapy in improving overall survival by eradicating     micrometastatic disease, the major cause of mortality from breast cancer. Despite the     well-documented benefits of adjuvant systemic therapy, it is not effective in preventing     death from breast cancer in all patients who are candidates for such treatment. The worth of     such therapy can only be judged in retrospect upon disease relapse, a time when breast cancer     is nearly always incurable. Currently, there are few reliable methods to predict the success     or failure of a particular postoperative treatment modality, and better ways to predict and     optimize outcome are needed.      Combination endocrine therapy: Using endocrine agents with different mechanisms of action     together has the potential advantage of more effectively blocking ER signaling, thus     improving the efficacy of such agents against breast cancer. In the past, attempts to combine     endocrine agents for ER-positive breast cancer have had mixed results, depending on the     setting and the patient population studied.      Endocrine agents without any agonist effect could potentially be used in combination with     aromatase inhibitors, under the rationale that the combination would maximally blockade     estrogen receptor signaling, thus potentially improving the antitumor effect. Fulvestrant     (FASLODEX) is a pure estrogen antagonist with no known agonist effect; thus, it has the     potential to provide additional benefit when combined with an aromatase inhibitor. This     concept provides the rationale for using the combination of anastrazole and fulvestrant in     this study.   "
207984|NCT00570336|"     The purpose of this study is to determine if CTS-1027 can lower elevated liver enzymes in     patients with chronic HCV infection.   "
207985|NCT00570349|"     The primary objective of the trial is to assess the safety and tolerability of inhaled nitric     oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable     Cystic Fibrosis (CF) subjects. Toxicity is to be defined as a drop in oxygen saturations, a     decline in forced expiratory volume in one second (FEV1), or an increase in methemoglobin.   "
207986|NCT00570362|"     The purpose of this study is to evaluate whether systemic glutathione level is decreased in     patients with normal tension glaucoma.   "
207987|NCT00570375|"     The purpose of this research study is to find out what effects, good and/or bad, Erlotinib     has on Myelodysplastic syndrome. Myelodysplastic syndrome is a group of blood diseases where     the bone marrow (spongy space in long bones which is the factory for blood cell production)     does not make enough blood cells and therefore there is a lack of healthy blood cells in the     body. This can result in anemia, risk for infection and/or bleeding..   "
207988|NCT00570388|"     This study will test the safety and efficacy of the PROMETA® Treatment Protocol (which     includes the benzodiazepine antagonist flumazenil) in reversing the neurocognitive impairment     and this in turn will lead to improved ability to resist alcohol related cues and enhance     involvement in psychosocial treatment.   "
207989|NCT00570401|"     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with     advanced lung cancer that is no longer responding to erlotinib or gefitinib.   "
207990|NCT00570414|"     Secure airway management is the basis of all anesthesiological practice. Of particular     importance is the securing of patients' airway passages when the surgical procedure itself     poses a threat to a patient's airway, as is the case in all procedures involving the upper     respiratory pathways. When adenoidectomies, tonsillectomies and combined adenotonsillectomies     are performed, blood from the surgical area will present a respiratory threat to unsecured     airways. The traditional opinion has been that endotracheal intubation is the safest method     of preventing aspiration.      The laryngeal mask was introduced in 1983 as an alternative to the endotracheal tube. In     1990, the flexible, reinforced laryngeal mask airway was introduced, intended for use during     surgical procedures involving the mouth and throat. The laryngeal mask airway has several     potential advantages over the endotracheal tube. It is inserted blindly, without     laryngoscopy. This leads to reduced oropharyngeal or laryngeal stimulation and injury, and     therefore minimal activation of respiratory and circulatory reflexes. The laryngeal mask     airway can be placed without the use of muscle relaxants, avoiding potential side effects     such as apnea, hyperkalemia and anaphylaxis. In addition the laryngeal mask airway can remain     in the throat until the patient awakes, virtually eliminating the danger of postoperative     aspiration.      Several international studies have described the advantages of the laryngeal mask airway over     endotracheal intubation during ear, nose and throat surgery in children. The general     impression is that there is a widespread routine implementation of the laryngeal mask airway.     In Norway, however, this practice has been limited. As far as we know, only Namsos Hospital     uses this procedure as its first choice. At Telemark Hospital we tested the use of laryngeal     mask airway on 150 patients between May and December 2006. The results so far have been     promising, and we have had no serious complications.      Hypothesis:      In children undergoing adenotonsillectomies, a laryngeal mask airway provides greater patient     satisfaction (judged by reduced pain, nausea and vomiting) and greater effectivity (judged by     reduced time in surgery), compared with the endotracheal tube. The laryngeal mask provides as     much as or greater secure airway management measured by desaturations/Sp02<92% and/or use of     suxamethonium and bronchiolytic drugs.   "
207991|NCT00570427|"     The purpose of this study is to improve access to quality depression care for older,     low-income, minority adults in public sector health care. The study will examine current     depression care in a public sector geriatric clinic that serves mostly Spanish-speaking     Latinos and pilot study assessments and treatments in order to lay the groundwork for a large     study of quality improvement for depressed older minorities   "
207992|NCT00570440|"     The primary objective is to determine if continuous COC use leads to higher continuation     rates over 12 months of follow up than use of the standard 28-day COC regimen.   "
207993|NCT00570466|"     Interactive multimedia programs have been demonstrated to produce substantial change in     children's dietary behaviors. This SBIR-Phase 2 protocol will evaluate the two video game     interventions designed to change diabetes related behaviors, including diet and physical     activity: Escape from Diab! and Nanoswarm that were developed in Phase 1. The primary     hypotheses for this SBIR-Phase 2 protocol are:        1. The two video games will result in greater dietary and physical activity change than a          knowledge based control group.        2. The effects of the video games will be mediated by changes in child preferences for FV          and PA, self-efficacy to change FV intake and PA, and intrinsic motivation to eat FV and          PA.      We will test these hypotheses by evaluating the two video games in a randomized experiment.     To minimize costs, we will evaluate the impact of the games on behavior (diet and PA), BMI     and related psychosocial variables, but not blood values. Our long-term goal is reducing the     incidence of Type 2 diabetes and related health problems in youth.   "
207994|NCT00570479|"     Retisert implant is an effective therapy for controlling inflammation in patients with     non-infectious posterior uveitis. One of the major complications of this device is the     development of elevated intraocular pressure (IOP) following implantation in 60% of patients.     Glaucoma filtering is required in over 30% of patients at 2 years. Anecortave acetate (AA)     has been shown to reduce steroid induced elevated IOP. The purpose of this study was to     evaluate the ability of prophylactic anterior juxtascleral depot administration of AA to     prevent this Retisert induced elevated IOP.   "
207995|NCT00570492|"     The primary objective of this study is to characterize, as accurately as possible, the     estimation of the difference in pre-pubescent growth velocities between subjects treated     continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in     the US, and placebo nasal spray as determined by stadiometry.   "
207996|NCT00570505|"     The purpose of this study is to determine whether the LAP-BAND system is safe and effective     in subjects with BMI ≥ 30 kg/m2 and < 40 kg/m2.   "
207997|NCT00570518|"     The main purpose of the study is to determine the accident risk when driving under the     influence of psychoactive substances, including alcohol (DUI). Other aims are to find out the     prevalence of psychoactive substances in road traffic and to obtain information on the role     of these substances in road traffic accident causations.      For the purposes of the study, drivers of motorised vehicles are randomly stopped and     interviewed and breath alcohol is recorded. Also, an oral fluid sample is taken and     psychoactive substances are investigated in the laboratory. For cases, drivers injured in     traffic accidents are asked to participate to the study. A whole blood sample and, if     possible, an oral fluid sample is taken and psychoactive substances are determined in the     laboratory. Also, people diseased in road traffic accident are included in the study. The     information required for these subjects are taken from a register database.      The study is part of an EU-project DRUID. Altogether 13 European countries take part to the     study.   "
207998|NCT00570531|"     The purpose of this study is to determine whether bevacizumab can improve the outcome of     treatment for patients with esophageal cancer whose disease is confined to the esophagus or     the closely surrounding lymph nodes.   "
207999|NCT00570544|"     To evaluate if tiotropium (Spiriva)induced bronchodilation of inspiratory capacity in     patients with moderate to severe copd subjected to metronome paced hyperventilation induced     dynamic hyperinflation is dependent upon the extent of underlying emphysema as determined by     high resolution-thin section CT lung.   "
208000|NCT00570557|"     This research aims to facilitate the successful implementation of the new Heart and Stroke     Foundation of Ontario dysphagia screening model for acute stroke patients. The objectives     will be 1) to determine the natural history of dysphagia screening skill decay, and 2) to     assess the benefit of independent web-based practice and periodic feedback on screening skill     maintenance. We will enrol a convenience sample of nurses who currently work with stroke     patients but who have had no prior formal training with dysphagia screening.      The study will consist of 2 phases: A) an initial pilot phase followed by B) a prospective     randomized controlled study. During Phase A, three new web-based, self-instructed skill     refresher courses will be developed to help nurses maintain the skills they will learn in an     8-hour workshop on dysphagia screening. During Phase B, nurses will receive the 8-hour     workshop and one-on-one evaluation by a speech-language pathologist (SLP). Following     training, competent screeners will be randomized into one of two groups: Group A - Control     group with no refresher course or periodic feedback from SLP; Group B - Web-based skill     refresher courses only. Nurses will be evaluated at several timepoints throughout Phase B to     assess theoretical dysphagia screening knowledge and skills.   "
208001|NCT00570570|"     Gait impairment remain one of the main problem for hemiplegic stroke patients. After the 6     first months, stroke patients are classically described with moderate or no improvement.     Here, we want to compare the effectiveness of a flexor and extensor paretic knee muscular     strengthening program with conventional physiotherapy delivered by the local physiotherapist     of the patient, in a very ecological way.   "
208002|NCT00570583|"     Late-life depression (LLD) and cognitive impairment (CI) are significant public health     problems among older adults, and their co-occurrence markedly increases disease burden and     dementia risk. This highlights the importance of identifying and treating CI in LDD; however,     current lack of reliable prognostic information from clinical, neuroimaging, and genetic data     impedes research on targeted prevention and treatment. Two critical ways to close current     knowledge gaps in predicting cognitive diagnostic outcomes of LLD involve: 1) increasing the     number of diagnostic cases available to existing studies, and 2) using those studies to     identify clinical, imaging, and genetic predictors that will improve future diagnosis. We     intend to do both in the current proposal. We plan to study the following SPECIFIC AIMS:      Aim 1: Identify baseline clinical-behavioral predictors of cognitive diagnostic outcomes in     LLD.      Working hypothesis: During acute LLD, CN will be associated with more frequent EOD and higher     negative life stress than PCI and AD; PCI will be associated with EOD and higher frailty than     CN and AD; AD will be associated with LOD, greater appetite loss, lower anxiety, and greater     memory impairment than CN and PCI.      Aim 2: Use multimodal neuroimaging at baseline to identify patterns associated with cognitive     diagnostic outcomes in individuals with LLD. Working Hypothesis: CN will be associated with     greater white matter integrity compared with PCI and AD; PCI will be associated with lower     white matter integrity and network abnormalities in anterior cingulate cortex compared with     CN; AD will be associated with lower hippocampal volume compared with CN and PCI.      Aim 3: (exploratory): Explore interrelationships among candidate genes, cognitive diagnostic     outcomes, and proposed phenotypic components relevant to LLD. Exploratory Hypotheses: 1) COMT     val158met polymorphism will be associated with CN; 2) 5-HTTPRL and APOE ε2 polymorphisms will     be associated with frailty; 3) genetic variation (SNPs) in TPH2 and AGTR1 will be associated     with risk factors of AD: LOD, episodic memory, hippocampal volume, and appetite loss.   "
208003|NCT00570609|"     This is a prospective study of 7th grade students participating in the CPR Anytime® program.     After consent, participants will be asked to complete the program with their parent(s)/legal     guardian(s) and encouraged to include other friends and family members in the program. After     completing the program, the participant and their parent(s) will be evaluated for adequacy of     chest compressions/CPR. The student participants will be evaluated again at 6 months for     adequacy of chest compressions/CPR      Objectives:        1. To evaluate 7th grade students for adequacy of CPR and chest compressions after          completing a take home CPR course        2. To evaluate the multiplier effect of students training in CPR with their parents/family          members using a take home CPR instructional kit        3. To evaluate the participating parent for adequacy of CPR and chest compressions after          completing a take home CPR course      Research Hypothesis:        1. 7th grade students can be trained, using CPR Anytime®, to perform adequate chest          compressions/CPR and their skills will be maintained at 6 months        2. As part of the multiplier effect, an additional 1.5 family members per participant will          be trained to perform adequate chest compressions/CPR   "
208006|NCT00570648|"     Hypothesis: 1% sodium hyaluronate (Healon), applied at end of surgery to the surface of a     corneal transplant will not shorten graft reepithelialization time when compared to coating     with nothing. We also wish to measure and compare visual acuity in this immediate post     operative period. We also wish to assess the safety of using this agent on the epithelium     post-operatively.      We will recruit 50 high risk patients (see inclusion criteria) here at the University of     Virginia to randomly receive nothing or sodium hyaluronate (Healon) on the ocular surface at     the end of surgery, and follow time to reepithelialization of the corneal transplant grafts.   "
208007|NCT00570661|"     The present study has been designed in order to evaluate safety and tolerability of ITF2357     in patients with active SOJIA with inadequate response or intolerance to standard therapy     with oral steroids and methotrexate, with or without previously used biologic agents, and to     have a preliminary evaluation of efficacy of ITF2357 in the treatment of SOJIA.      ITF2357 will be administered orally at the daily cumulative dose of 1.5 mg/kg: this dose in     children/young adults is considered roughly equivalent to the dose of 1 mg/kg/day in adults,     which so far has been proven to be free of any relevant safety concerns both in healthy     volunteers and in patients.   "
208008|NCT00570674|"     The purpose of the Phase I part of this research study is to determine the safest and most     effective dose of Abraxane when given in combination with carboplatin and Erbitux during     radiation therapy for head and neck cancer. The purpose of the Phase II part of this study is     to determine the effects of the treatment on head and neck cancers, as well as to further     study the safety of this treatment.   "
208009|NCT00570687|"     The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled     visits. The visits comprised an initial screening visit, 3 treatment visits for the meal     challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3     sequential visits for the glucose clamp, and a final close-out visit.      Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for     each completed subject. The visits comprise an initial screening visit, 2 treatment visits     for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety     visit, 2 sequential visits for the glucose clamp, and a final close-out visit.      For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the     clinical unit for all procedures.   "
208010|NCT00570700|"     The purpose of this research study is to find out if a new anti-cancer drug, dasatinib     (Sprycel®), previously approved for treatment of some forms of leukemia, will be safe and     helpful in treating patients with hormone-refractory prostate cancer.      This is a research study because the study drug, dasatinib (Sprycel®), has not been evaluated     for safety or effectiveness in patients with hormone-refractory prostate cancer. The drug is     approved by the Food and Drug Administration for treatment of some forms of leukemia; thus,     dasatinib (Sprycel®) is not an investigational drug. It has been given safely to hundreds of     patients already. However its safety and usefulness in this study population (prostate     cancer) is unknown.      Subjects who agree to participate will take 150mg (3 pills) of dasatinib (Sprycel®) daily by     mouth for as long as the drug benefits them. During this time, the subject will periodically     return to the office for blood/urine tests, X-rays, imaging scans, and/or to complete     questionnaires.   "
208011|NCT00570713|"     The purpose of this study is to investigate the activity of MORAb-009 when added to a     standard regimen of gemcitabine in patients with previously untreated unresectable stage 3 or     4 pancreatic cancer.   "
208012|NCT00570726|"     This study was designed to evaluate the efficacy and safety in the use of Ranibizumab, an     effective vascular endothelial growth factor (VGEF) inhibitor, in treating patients with a     failing bleb, characterized by increased fibrosis and vascularization of the conjuctiva,     following trabeculectomy. Six subjects from one site will be enrolled in this study.   "
208013|NCT00570739|"     This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl))     study in the type 2 diabetic subjects and pre-diabetic subjects. Diabetic participants will     also be treated with open label, background,metformin HCl. Two-hundred sixty subjects with     type 2 diabetes (T2DM) and 200 pre-diabetic subjects are planned to be be enrolled. Qualified     subjects with T2DM will be randomized 1:1 to receive metformin HCl plus colesevelam HCl or     metformin HCl plus placebo matching colesevelam HCl. Qualified pre-diabetic subjects will be     randomized 1:1 to receive colesevelam HCl or matching placebo.   "
208014|NCT00570752|"     The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation     in atherosclerotic plaque   "
208015|NCT00570765|"     The primary hypothesis is that INT 747 will cause a reduction in alkaline phosphatase levels     in PBC patients, over a 12 week treatment period, as compared to placebo.   "
208016|NCT00570778|"     This study will evaluate the safety and efficacy of QVA149 in patients with moderate to     severe COPD.   "
208017|NCT00570791|"     The primary purpose of this study is to evaluate the effects of ocular physical properties on     intraocular pressure (IOP) measurements in eyes with healthy corneas using the following     instruments to measure IOP: Goldmann applanation tonometer, pneumotonometer, ocular blood     flow pneumotonometer, Tono-Pen, Pascal Dynamic Contour Tonometer and the Schiotz Tonometer.     Ocular physical properties to be evaluated are:varying (CCT), corneal curvature (CC), axial     length, anterior chamber depth and scleral rigidity. The secondary purpose of this is to     determine if there is a correlation between CCT and other ocular properties, and which     instruments that measure these other ocular properties are most affected by CCT.   "
208018|NCT00570804|"     Objectives:        1. Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.        2. Assess MAPS and MAPS+ effects on treatment mechanisms (increased self-efficacy,          decreased temptations/craving, decreased stress and negative affect) and the role of          those mechanisms in mediating MAPS and MAPS+ effects on alcohol at-risk behaviors and          smoking cessation.        3. Evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking          and smoking cessation.   "
208031|NCT00570973|"     Patients with liver cirrhoses and recent history of variceal bleeding, with HVPG documented     non response to medical therapy with non selective beta blockers +/- mononitrates or variceal     rebleeding during adequate medical therapy will be randomized to undergo either multi-session     endoscopic multi-band ligation and continuation of medication or TIPS placement. Best     treatment for this group of cirrhotic patients is not known so far.   "
208019|NCT00570817|"     Infusions with high-dose methotrexate 5 g/m2 or 8 g/m2 are used to treat children with acute     lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma, medulloblastoma and ependymoma.     Methotrexate is primarily excreted unchanged by the kidney where it can course acute kidney     damage resulting in prolonged time of excretion of the drug. Our main hypothesis is that 12     hours of intravenous hydration before the methotrexate infusion is more efficacious in     preventing methotrexate induced kidney damage compared to four hours of hydration.   "
208020|NCT00570830|"     To review chart data at the Duke Eye Center and determined whether a 3-year fluocinolone     acetonide sustained drug delivery system (FA) safely suppressed postoperative inflammation     when combined with phacoemulsification and posterior chamber intraocular lens implantation     (phaco/PCIOL) in eyes with severe uveitis.   "
208021|NCT00570843|"     The objective of this study is to evaluate the effect of a new PEG based artificial tear as     compared to Optive on comfort, wear time, and vision in patients wearing contact lenses.   "
208022|NCT00570856|"     To see the effect of Folic acid supplementation after kidney transplantation on plasma total     homocysteine level and carotid intimal-media thickness   "
208023|NCT00570869|"     This research will be a prospective, cohort study to determine if mothers of infants/newborns     are more willing to complete CPR training using a 22-minute instructional DVD and infant     manikin versus traditional four hour didactic instruction.      Study Hypothesis: A 22-minute instructional DVD and infant manikin will be an effective and     preferred tool for teaching mothers of infants infant CPR.      Objectives        1. To determine if mothers of infants are more likely to complete infant CPR training with          a 22-minute instructional DVD and infant manikin, than by attending a traditional CPR          class.        2. To determine if learning infant CPR with a 22-minute instructional DVD and infant          manikin is as effective as attending traditional infant CPR class.        3. To examine the number of mothers that were offered the opportunity to learn infant CPR          either as part of their prenatal classes, or upon the birth of their infant.        4. To examine the number of mothers who have been previously trained in CPR.        5. To examine the reasons that mothers have been previously trained in CPR (e.g., mandated          by work/career vs. personal reasons).        6. To examine the multiplier effect of an at home CPR education using a 22-minute          instructional DVD and infant manikin at the time of the follow up phone call.   "
208024|NCT00570882|"     This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1     regimen in previously untreated metastatic RCC to select the most promising regimen, which     should be used in further studies of this patient population.   "
208025|NCT00570895|"     Iron deficiency is a common health problem worldwide. Ferrous fumarate (a form of iron) is     often added to foods in an effort to prevent iron deficiency. Vitamin C can improve the     amount of iron that the body absorbs, therefore it is often added to foods too. However, we     don't know if vitamin C really increases the absorption of iron from ferrous fumarate.      This study will measure the iron absorption in children from a meal containing some ferrous     fumarate with and without vitamin C. The study will include 4 visits to the Children's     Nutrition Research Center in Houston, TX.   "
208026|NCT00570908|"     The purpose of this study is to assess the efficacy and safety of concurrent whole brain     radiotherapy (WBRT) and capecitabine followed by combination capecitabine and sunitinib in     treating patients with CNS metastases from breast cancer.   "
208027|NCT00570921|"     The primary objective of this study is to determine if estrogen receptor-targeted therapy     with fulvestrant used in combination with Everolimus is an effective and safe therapy for     women with hormone receptor positive metastatic breast cancer after failure of aromatase     inhibitor therapy.   "
208028|NCT00570934|"     2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with     Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone     mineral turnover and/or bone mineralization.   "
208029|NCT00570947|"     In this study we hope to show that prescriptions provided for CPR Anytime™ to patients who     are at risk for or have heart disease at three key locations, can motivate families to learn     the skill. We will use our ED sites, an office based primary care setting, and an office     based cardiology practice. Participants will be given the pharmacy locations where they can     be purchased. Optimally they will complete the program at home with their family.      Research Hypothesis:        1. Families of patients at risk for coronary artery disease can be motivated to learn CPR          by receiving a prescription for a CPR Anytime ™ self learning kit.        2. As part of the multiplier effect, an additional 1.5 family members per participant are          projected to be trained to perform CPR.        3. Families may experience a teachable moment when their loved one is in the emergency          department. In comparison to the office settings, this may increase the likelihood that          they fill the prescription for CPR Anytime® and complete the learning kit.   "
208030|NCT00570960|"     The core of the proposal is a prospective, randomized, double-blinded, controlled study which     will compare the efficacy of dextran 70 versus human albumin in the treatment of cirrhotic     patients with spontaneous bacterial peritonitis (SBP). Because dextran 70, which is FDA     approved for plasma volume expansion, is significantly less expensive than human albumin,     this study is designed and powered to determine if dextran 70 is equivalent in clinical     efficacy when compared to albumin.      Specific aims for this project are to:        1. Assess the effect of plasma volume expansion with dextran 70 on disease-specific          mortality at 30 days in cirrhotic patients with spontaneous bacterial peritonitis          compared to plasma volume expansion with human albumin.        2. Assess the effect of dextran 70 compared to human albumin on the prevention of renal          dysfunction within 30-days of diagnosis of SBP, as measured by the calculated creatinine          clearance, plasma renin activity, serum aldosterone levels, levels of brain natriuretic          peptide, and further development of the hepatorenal syndrome in cirrhotic patients with          spontaneous bacterial peritonitis.        3. Compare the survival to liver transplantation, treatment costs, hospitalization costs,          resource utilization, and quality of life of patients with spontaneous bacterial          peritonitis treated with dextran 70 and human albumin in the 30 days following          diagnosis.        4. Establish a comprehensive tissue bank of blood, ascites, and urine in patients with          spontaneous bacterial peritonitis for future testing and translational research.        5. Establish a clinical electronic database with web-based data entry and remote analysis          capabilities linking tissue bank samples and patient outcomes related to the above          clinical trials.   "
208033|NCT00570999|"     This is a double blind, placebo controlled clinical trial, where patients with an advanced     form of blood cancer are treated with haploidentical allogeneic peripheral blood progenitor     cell (PBPC) transplant after which they are randomised to receive either placebo or a     keratinocyte growth factor (Palifermin or Kepivance®).      The function of Kepivance® is to stimulate the growth of epithelial cells. This drug has also     been suggested to have an ability to help improve the reconstitution, or development, of the     immune system after the transplantation.      The hypothesis is that the patients T-cell dependent humoral immune response to recall     antigen (PrevenarTM) will be higher in in palifermin treated patients than in the placebo     control group   "
208034|NCT00571012|"     Intraocular pressure (IOP) varies with body position, with a significant increase occurring     from the seated to the supine position. Previous research has indicated that the IOP increase     cannot be explained by changes in episcleral venous pressure(blood flow leading away from the     eye) alone. As well, previous research has indicated that aqueous flow rate is independent of     body position. The purpose of this project was to determine if aqueous humor outflow facility     varied with changes in posture.   "
208035|NCT00571025|"     The purpose of this study is to determine the characteristics of those who obtain genetic     susceptibility testing for Alzheimer's disease with APOE disclosure and to study the     psychological and behavioral consequences of providing this information.   "
208036|NCT00571038|"     The primary purpose of this project is to establish the efficacy of a novel peer support     intervention to reduce hypertension among members of veteran service organizations (VSOs).     Specifically, we plan to demonstrate that veterans participating in a peer support     intervention, as opposed to a purely didactic educational program, will have better blood     pressure (BP) control, increased engagement in blood pressure lowering activities (such as     exercise), and a more active stance as patients.   "
208037|NCT00571051|"     The purpose of this research is to investigate the effects of mindfulness based stress     reduction (MBSR) on measures of brain function. We are looking especially at the ways in     which MBSR may affect the way the brain processes the sense of touch. The study seeks to     recruit healthy, normal adults who are interested in MBSR training, a simple program that     involves learning how to pay attention mindfully to the present moment   "
208038|NCT00571064|"     This is a study to determine the effectiveness and safety of donepezil hydrochloride (E2020)     used to treat residents of assisted living facilities diagnosed with mild, moderate, or     severe stage Alzheimer's disease.   "
208039|NCT00571077|"     Patients over the age of 18 with thyroid nodules scheduled for surgery will undergo EIS scan.     Each node will be scanned and graded form 1-5 (1=benign, 5=malignant). Results will be     compared with final histopathology.   "
208040|NCT00571090|"     The aim of this study is to identify which ultrasonographic feature or a combination of     features is the best predictor of thyroid cancer in thyroid nodules.   "
208041|NCT00571103|"     The purpose of this study is to see whether acamprosate (Campral) will curb the desire to     gamble in people with pathological gambling disorder.   "
208042|NCT00571116|"     This phase I trial is studying the side effects and best dose of arsenic trioxide when given     together with disulfiram in treating patients with metastatic and progressive melanoma. Drugs     used in chemotherapy, such as disulfiram and arsenic trioxide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving more than one drug (combination chemotherapy) may kill more tumor cells.   "
208043|NCT00571129|"     Endoscopic dacryocystorhinostomy (EN-DCR) is an effective procedure when treating saccal and     postsaccal obstructions of the nasolacrimal pathway. The benefit of silicone tubing after DCR     is still controversial. We conducted a prospective, randomized study in order to evaluate 1)     the necessity of bicanalicular silicone tubes after primary EN-DCR, 2) efficacy of the     perioperative Mitomycin C for the prevention of adheesion and re-stenosis of rhinostomy site     in revision EN-DCR, 3) the subjective symptoms and QoL changes before and after     DCR-operation.   "
208044|NCT00571142|"     To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and     visual acuity in patients with diffuse diabetic macular edema and their relation to renal     disease.   "
208045|NCT00571155|"     The purpose of this study is to determine the feasibility, efficacy and safety of intravenous     and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and     symptomatic epilepsy in the period of neurosurgical intervention.   "
208046|NCT00571168|"     1. Scientific background In patients with multiple myeloma high-dose chemotherapy followed          by autologous stemcell transplantation is preferred to conventional therapy, since the          superiority in respect to complete remission, complete remission duration, event-free          survival and overall survival has been proven within well controlled clinical trials          (Fassas et al., 2002; Goldschmidt et al., 2003).           Nausea and vomiting are well known and the most distressing side-effects of a high dose          chemotherapy regimen. The administration of selective 5-HT3-receptor antagonists (5-HT3          RAs) in combination with a corticosteroid (= antiemetic standard therapy) is effective          for the prevention of those adverse effects in 70 to 80 % of patients. However, 25 to 40          % of the patients still suffer from vomiting and nausea in the delayed phase of the          chemotherapy. Superior protection could be achieved with the addition of Aprepitant          (EMEND®) to the antiemetic standard therapy in acute and delayed phases of highly          emetogenic chemotherapies. The enhanced antiemetic protection can be maintained over          multiple chemotherapy-cycles to an extent superior to that of standard therapy alone (de          Wit et al., 2003).           Furthermore addition of Aprepitant (EMEND®) to standard therapy was generally well          tolerated and the impact of chemotherapy-induced nausea and vomiting (CINV) on daily          life was significantly reduced (Hesketh et al., 2003; Dando & Perry, 2004).        2. Trial Rationale Aprepitant (EMEND®) is a selective high-affinity receptor antagonist of          human substance P/neurokinin-1 (NK1) and has been shown to inhibit emesis induced by          cytotoxic chemotherapeutic agents and augments the antiemetic activity of 5-HT3 RAs          (e.g. Granisetron, Ondansetron) and corticosteroids (e.g. Dexamethasone). Thus          Aprepitant (EMEND®) in addition to antiemetic standard therapy has been shown to possess          powerful superior protection and has been reported in several clinical trials to          significantly improve both acute and delayed CINV.      The aim of this study is to evaluate, during and up to 7 days after high-dose chemotherapy     with Melphalan (moderate emetogenic drug) followed by autologous peripheral blood stemcell     transplantation, an antiemetic treatment regimen in respect to efficacy and safety in     patients with multiple myeloma. To the best of our knowledge effects of Aprepitant on     Melphalan induced CINV have never been investigated.   "
208047|NCT00571181|"     The purpose of this study is to compare manual administration of propofol and remifentanil     and dual closed-loop using bispectral index as the control variable during rigid     bronchoscopy.   "
208048|NCT00571194|"     Many children with end stage renal disease develop hyperlipidemia. HMG-CoA     (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, such as pravastatin, are     typical treatments for hyperlipidemia. However, we do not know how pravastatin is metabolized     in patients on dialysis. This study is designed to provide preliminary pharmacokinetic data     for pravastatin in pediatric patients on peritoneal dialysis.   "
208049|NCT00571207|"     This research includes the evaluation of a checklist and on-site screening devices to     pre-select drivers suspected of being drug-impaired. The reliability of a limited number of     promising on-site screening devices will be investigated. The devices tested will have to be     promising regarding both reliability and practicality. In addition to the scientific     evaluation of the checklist and the oral fluid screening devices, the time consumption of the     selection procedure as a whole (checklist + oral fluid screening) will be evaluated.      Outcome of the study will be recommendations for the roadside selection procedure of drivers     suspected of drug-related impairment. The recommendations will concentrate on the reliability     of the selection procedure.      The study is part of an EU project DRUID. Two other countries in Europe take part to this     study along with Finland.   "
208050|NCT00571220|"     Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking     bariatric surgery have T2DM. Although all surgeries result in significant weight loss and     often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass     (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the     improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by     weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance     insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific     anatomical changes after this surgery. While some determinants of impaired insulin secretion,     such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in     the incretin effect after GBP might be specific to this surgery. The AIM of this study is to     determine whether the magnitude of the incretin effect on insulin secretion is greater after     GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients     with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent     weight loss on the incretin effect (difference in insulin secretion after comparable oral and     intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding     the mechanisms that produce improvement in their diabetes is increasingly important.   "
208051|NCT00571233|"     The purpose of this study is to determine if children with heart disease where there is only     one pumping chamber(ventricle) have proteins (biomarkers) in the blood that can be used to     monitor the function of their heart.   "
208052|NCT00571246|"     The objective of this study is to evaluate the efficacy of topiramate (250mg) or lamotrigine     (250mg) versus placebo in reducing alcohol consumption and decreasing symptoms of PTSD in     patients with comorbid AD and PTSD.   "
208053|NCT00571259|"     The study is a randomized, double blinded, prospective, multicenter, clinical trial. All     patients requiring vascular access with a tunneled central venous catheter for hemodialysis     are eligible for enrollment. Patients will be randomized to receive either Heparin 1,000 U/ml     in a volume sufficient to fill the catheter length in both ports or to receive 4% Sodium     Citrate with Gentamicin 320 mcg/mL in a volume sufficient to fill the catheter length in both     ports.We hypothesize that the device related infection rate in the Citrate/Gentamicin group     will be less than the heparin arm.   "
208054|NCT00571272|"     Cholestasis is a condition in which bile is not properly transported from the liver to the     small intestine. Cholestasis can be caused by an array of childhood diseases, including the     genetic diseases Alagille syndrome (ALGS), alpha-1 antitrypsin (a-1AT) deficiency, bile acid     synthesis and metabolism defects, and progressive familial intrahepatic cholestasis (PFIC) or     benign recurrent intrahepatic cholestasis(BRIC). This study will investigate the natural     history and progression of the four previously mentioned cholestatic liver diseases to     provide a better understanding of the causes and effects of the diseases.   "
208055|NCT00571285|"     Retrospective review of records in the Emory Movement Disorders clinic suggests vitamin D     deficiency occurs in over 80% of patients with Parkinson's Disease (PD), much more frequently     than in internal medicine clinics. Laboratory studies have suggested vitamin D could play a     role in the development of PD. In addition, low vitamin D levels have been associated with     slower walking speeds, worse memory and thinking, and depression.   "
208056|NCT00571298|"     RATIONALE: After removal of visible cancer in the chest, chemotherapy drugs are used to kill     or stop tumor cells from dividing, so that they stop growing or/and die. Cisplatin is     currently used safely as in intra-operative treatment for malignant pleural mesothelioma.     This study is aimed to determine if the addition of gemcitabine as a second intracavitary     chemotherapy can be accomplished safely.      PURPOSE: This is a Phase I trial to study the efficacy of combination chemotherapy consisting     of gemcitabine and cisplatin administered in the operating room and put into the chest and     abdomen for one hour. We are also looking at the effects of heating the chemotherapy to a     temperature of 42 degrees Celsius and the effect of cytoprotection agents: amifostine and     sodium thiosulfate to counteract potential side effects of chemotherapy.   "
208057|NCT00571311|"     This study will evaluate how adolescents enrolled in clinical research and their parents:        -  Understood the study information presented before they agreed to participate        -  Made decisions about enrolling in the study        -  Experienced the process of assent and consent        -  Perceive the experience of participating in research      The study will determine how adolescents and their parents evaluate risk and benefit, what     information they use in making their research enrollment decisions, and how these decisions     are made.      In recent years the medical community and the federal government have increasingly recognized     the need to conduct pediatric research. Several initiatives have resulted in an expanding     number of studies that include children. With more pediatric research comes the need to     ensure that protections for the rights and safety of children enrolled in research are     performing well.      Adolescent patients between 13 and 18 years of age who are enrolled in a research study at     the NIH involving cancer, diabetes mellitus, vaccines, obesity, bipolar disorder, and HIV, as     well as healthy adolescent controls, may be eligible. One parent of each adolescent also     participates.      Participants are interviewed at the NIH Clinical Center. Each interview will last about 30     minutes and consists of questions in the following areas:        -  Demographics (age, sex, ethnicity, education, socioeconomic status, etc.)        -  Brief medical history of the adolescent        -  Experience and satisfaction with the parental permission/assent process        -  Motivations for participating in clinical research        -  Decision-making process        -  Willingness to accept certain types and levels of hypothetical risks in a study,          including those of side effects and invasive procedures        -  Willingness to enroll with different chances of possible benefit        -  Comparison with other activities        -  General understanding of research...   "
208058|NCT00571324|"     The purpose of this study is to determine if Exendin-(9-39), an antagonist of the     glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases     fasting blood glucose levels in subjects with congenital hyperinsulinism.   "
208240|NCT00574704|"     The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in     patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a     double-blind, placebo-controlled setting   "
208059|NCT00571337|"     1 Project summary 1.1 Rational. Accent 1 study has demonstrated the superiority of Infliximab     over placebo in a systematic treatment strategy of Crohn 's disease every 8 weeks during one     year. However the optimal strategy beyond one year of treatment is not established.     Particularly, the need for carrying on systematic treatment with infliximab in all the     patients has not been demonstrated.      1.2 Primary objective. Determine factors associated with a low risk of clinical relapse after     stopping infliximab in CD patients in remission (CDAI<150) and regularly treated with     infliximab for at least one year.      1.3 Main objective and main judgement criteria. Determine predictive factors for relapse     within one year after stopping infliximab. Main judgement criteria is the clinical relapse     after stopping infliximab. Clinical relapse is defined either by a CDAI>250 or by a CDAI     between 150 and 250 if this CDAI is confirmed over two consecutive weeks with an increase of     at least 70 points over baseline for the two consecutive measures.      1.4 Secondary objectives and judgement criteria. Determine the time to-relapse Determine     predictive factors for short-term relapse (<2 months)after stopping infliximab.      Determine response to infliximab retreatment in these patients. Determine tolerance to     infliximab retreatment in these patients. Determine predictive factors for an absence of     response to retreatment. Determine predictive factors for infliximab retreatment intolerance.     Determine sustained response in the retreated patients.      1.5 Type of study Open-label prospective study of stopping regular treatment. Inclusion     period: minimum one year, possibly prolonged to reach 100 patients. Patients will be followed     up every two months for at least 18 months after stopping infliximab.      1.6 Justification of the number of patients Number of patients to include is at least 100.     This recruitment should be reached within one year. This number should allow to disclose     predictive factors associated with a relative risk of at least 2 if this factor is     equilibrated (50% at risk patients) or 3 is this factor is disequilibrated (90% at risk     patients).   "
208060|NCT00571350|"     The purpose of this study is to assess the effectiveness of the polypropylene tape in     preventing cystocele recurrence when placed underneath the bladder base as a concomitant     measure to the anterior colporrhaphy procedure.   "
208061|NCT00571363|"     We have compared to types of surgery to assess which one leaves the smaller surgical defect.   "
208062|NCT00571376|"     The purpose of this study is to measure the financial effects of health information     technology and health information exchange in regional health information organizations in     New York State.   "
208063|NCT00571389|"     Primary Objective:      This is a study to investigate the feasibility of harvesting, expanding in culture, and     freezing circulating tumor cells and immune cells from cancer patients and healthy     volunteers.   "
208064|NCT00571402|"     This study will evaluate the effectiveness of family-focused psychoeducational treatment     along with medication in treating adolescents with bipolar I disorder.   "
208065|NCT00571415|"     Within this study patient data are collected from different imaging and motion monitoring     devices that will be used to develop and test strategies for image-guided adaptive     radiotherapy in cervix cancer patients.   "
208066|NCT00571428|"     To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD     (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate     inhalation solution 15μg/2 mL BID in subjects with COPD.   "
208067|NCT00571441|"     We hypothesize that the stroke volume variation measured using the commercially available     LiDCO monitor provides a reasonable estimate of volume when compared to standard measures.     This study will collate data that is already being collected by the bedside nurses.   "
208068|NCT00571454|"     The purpose of this study is to determine whether telephonic depression care management can     improve depression outcomes for Latino primary care patients who are enrolled in Medicaid and     are receiving an antidepressant from their primary care doctor.   "
208069|NCT00571467|"     The primary purpose of this study is to evaluate the safety of multiple doses of     Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia     Purpura (ITP). The pharmacokinetics, immunogenicity and pharmacodynamics will also be     studied.      Patients will be enrolled into 1 of 3 dose groups and receive 4 weekly IV doses of PRTX-100.     A Safety Monitoring Committee will review safety data through Day 28 for the first 5 patients     in a dose group before escalation to the next higher dose level. Patients will be followed     for 8 weeks after dosing for safety, PK, immunogenicity and effect on platelet     count(pharmacodynamics).   "
208070|NCT00571480|"     Ear acupuncture can be used as a treatment for pregnancy induced low back pain.   "
208071|NCT00571493|"     This is a Phase I/II trial designed to study the toxicity and Maximum Tolerated Dose of     VELCADE in combination with BEAM and autologous hematopoietic stem cell transplantation and     to obtain a preliminary estimate of the response rate to this combination.   "
208072|NCT00571506|"     The purpose of this study is to examine the effects of two diabetes medications,     rosiglitazone and pioglitazone, on markers of vascular disease in subjects with type 2     diabetes.   "
208073|NCT00565695|"     The purpose of this study is to evaluate the visual outcomes and patient satisfaction after     bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare     it to a historical control group of patients implanted bilaterally with the spherical ReSTOR     multifocal IOL.   "
208074|NCT00565708|"     We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in     patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in     this patient population over placebo control. If indeed found to be beneficial, because     aspirin is cheap and easy to administer, it will positively impact the lives of many     individuals in Asia and globally.      STUDY OBJECTIVE      To assess the effectiveness of Aspirin against placebo control in patients with dukes C or     high risk dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall     Survival (OS)      Primary endpoints        -  DFS among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer          and rectal cancer patient sub-groups);        -  DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer).      Secondary endpoints        -  Overall survival (OS) over 5 years        -  DFS and OS in             -  Chinese, Malay, Indian and other ethnic groups             -  Resected high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer               sub-groups, individually             -  Compliant versus non-compliant subjects             -  PIK3CA mutated tumors (where samples are available)   "
208094|NCT00565981|"     Open label multicenter, two-step, non-randomized (pilot) study to analyze the safety of 4     cycles of 3-day 40mg/m2 oral fludarabine with simultaneous thrice weekly application of 30mg     alemtuzumab s.c. in patients with B-CLL disease in 1st and 2nd relapse after any primary     treatment or with disease refractory to any therapy in 1st or 2nd line (including     Fludarabine, ). This regimen is preceded by an escalation phase with 3-10-30 mg of     alemtuzumab s.c.      After the first phase (completed treatment of 7 patients) an interim analysis of safety and     efficacy will be performed. In case of a sufficient risk benefit assessment followed by the     enrollment of further 21 patients. Final analysis of safety and preliminary efficacy will be     based on all patients enrolled.   "
208189|NCT00574041|"     This study is to find out if starting at low dose Avonex and slowly increasing to full dose     will improve flu like symptoms as a side effect of Avonex treatment.   "
208075|NCT00565721|"     This proof-of-concept study is designed to assess the ability of [18F]AH-111585 PET imaging     to detect tumors and angiogenesis. Up to 30 evaluable subjects are planned to be included at     up to 2 study centers in the US. Subjects are considered evaluable if they undergo     administration of AH-111585 (18F) Injection, dynamic and static PET imaging, and tumor tissue     acquisition. The targeted population is adult subjects at initial diagnosis or recurrence     with tumors ≥2.5 cm in diameter who are scheduled to undergo resection or biopsy of the tumor     as a result of routine clinical treatment. The tumors must belong to one of the following 5     types:        -  High-grade glioma, including glioblastoma multiforme, anaplastic astrocytoma, and          anaplastic oligodendroglioma        -  Lung cancer, including small cell lung cancer and non-small cell lung cancer        -  Head and neck (H&N) tumors, including laryngeal squamous cell carcinoma,          well-differentiated thyroid and oral cavity carcinoma        -  Sarcoma        -  Melanoma      Safety will be assessed from the rates of adverse events, changes in vital signs, changes in     electrocardiogram (ECG) parameters, changes in physical examination findings, and changes in     clinical laboratory findings.      Efficacy will be assessed as the correlations between parameters derived from the PET images     and the reference standards. The reference standards will be immunohistology for αvβ3     integrins and other biomarkers specific for oncology and angiogenesis and from the standard     of care imaging.      Measures obtained from optional DCE-CT imaging may also be used to compare the uptake and     retention of [18F]AH-111585 in tumors obtained from the dynamic PET to assess functional     status of the vascular system of the tumor.   "
208076|NCT00565734|"     The primary purposes of this study are to compare anterior and posterior surgical approach in     treatment of CSM ad to compare variations in treatment and outcomes of CSM worldwide.   "
208077|NCT00565747|"     This study is to assess whether addition of 2 ng/ml GM-CSF into a specific culture medium     will increase the chance of a pregnancy after in vitro fertilisation.   "
208078|NCT00565760|"     This is a Phase 3 double-blind, multiple dose safety extension study of Q8003 administered at     daily doses up to 36 mg morphine/24 mg oxycodone (Q8003 36mg/24mg) over a treatment period of     up to 4 weeks. Patients with acute moderate to severe pain who have completed participation     in one of the designated QRxPharma, Inc. acute pain lead-in studies will be eligible for this     trial.   "
208079|NCT00565773|"     Acute rejection is a common problem after a kidney transplant. Rejection can occur when the     kidney recipient's immune system tries to attack (or reject) the new kidney. Rejection     typically most often develops in the first few months after a transplant.      This single center study will seek to determine if a new combination of anti-rejection     medications, including the recently FDA approved drug called Belatacept, is better than the     current standard anti-rejection drug regimen at preventing rejection. Also to be determined     will be whether the new combination of drugs will allow participants to wean off their oral     anti-rejection medications over time.      This study will test the safety and effectiveness of a new investigational drug combination     using alemtuzumab, belatacept, and sirolimus when given with or without donor bone marrow.      This combination of medicines has not been tested before in humans. Alemtuzumab (Campath) is     approved for use in some types of white blood cell cancers, but is considered investigational     in transplant patients. Belatacept is now FDA approved and is being studied in transplant     patients. Sirolimus (Rapamune) is approved for use in transplant patients, but its use with     belatacept and alemtuzumab is investigational.      In the initial 20 subjects enrolled in the study, half tested whether an infusion of bone     marrow from the kidney donor would improve the effect of these drugs. This bone marrow     infusion was also considered investigational.      Enrollment of 20 additional subjects was begun in January, 2013. The donor bone marrow     infusion has been eliminated. Enrollment was open to primary living and deceased donor kidney     recipients. Enrollment is closed as of 8/12/2014.      Funding Source - FDA OOPD   "
208080|NCT00565786|"     The purpose of this prospective clinical data-collection is to document the performance,     clinical outcomes, and wear rates of ArCom® and ArComXL® Polyethylene. The data gathered will     be collated and used as a part of Biomet's post-market surveillance system and to provide     feedback to designing engineers, support marketing efforts, and answer potential questions     from reimbursement agencies.      Inclusion/exclusion criteria are identical to those indications and contraindications stated     in the FDA approved labeling for the device in 510(k) K926107 and 510(k) K043051. Surgical     techniques and patient care are to be standard for the surgeons participating in the     protocol.   "
208081|NCT00565799|"     PROTOCOL SUMMARY      Type of Study: Pilot, randomized and single center trial Test Procedure: Omentectomy Aim 1.     Determine the effect of omentectomy on 1) insulin sensitivity, 2) beta cell function and 3)     plasma markers of inflammation We hypothesize that removal of omental fat increases insulin     sensitivity and pancreatic sensitivity to glucose, and decreases systemic inflammation.      Aim 2. Identify genes and proteins in adipocytes from obese patients that affect clinical     presentation versus those that are affected by obesity for future study.      We hypothesize that the genetic samples will help us to identify genes and proteins in     adipocytes from obese patients that affect clinical presentation versus those that are     affected by obesity and help us to design future obesity genetic studies.      Total Enrollment Number: 30 patients who are scheduled to undergo bariatric surgery for     weight loss at New York University Medical Center will be invited to participate in this     study. Subjects will be randomly assigned, by using a computer-generated randomization     scheme, in a single-blind fashion to either the omentectomy (n=15) or control group (n=15).   "
208082|NCT00565812|"     The objective of this 2-year study is to evaluate the safety, tolerability and disease     modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in     overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be     evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment     of the study knee as the primary endpoint.   "
208083|NCT00565838|"     The objective of the study was to evaluate the impact AFS and TVT procedures on     quality-of-life in incontinent women.   "
208106|NCT00571675|"     This is a randomized, double-blind, placebo-controlled, multinational Phase 2 study to     evaluate and compare oral AT-101 in combination with docetaxel and prednisone versus     docetaxel and prednisone plus placebo in the treatment of chemotherapy-naïve metastatic     hormone-refractory prostate cancer, who have received hormonal therapy but not chemotherapy.   "
208085|NCT00565864|"     Patients with hypothyroidism are routinely treated with thyroid hormone (l-thyroxine) for     replacement therapy. Physicians monitor the thyroid hormone dose by measuring a thyroid     stimulating hormone (TSH) level in the blood, with the goal of a normal level. However,     recent data suggest that the normal TSH range is too broad, and that patients may still     have symptoms if their TSH levels are at the top or bottom part of the normal range.      To study this issue, it is useful to address issues such as general health status,     psychological symptoms, mood, memory, and metabolic status, since thyroid hormone has major     effects on the brain adn metabolism, and since patients with treated hypothyroidism often     have symptoms related to these areas.      In the present study, otherwise healthy subjects with treated hypothyroidism, ages 20-75     years, will be enrolled in a 7-11month study. At baseline, they will have tests of health     status, psychological symptoms, mood, memory, body composition, and energy expenditure     performed. Following these baseline measurements, subjects will receive either their usual     doses of l-thyroxine, or a slightly higher or lower dose. The doses will be chosen to try to     achieve either a low-normal TSH level, a high-normal TSH level, or a mildly elevated TSH     level. Which target TSH the patient is assigned will be determined randomly, and neither the     subject nor the study contacts will know which dose the patient is receiving. Subjects will     be seen every 6 weeks during the study for brief visits to make sure they are not having any     side effects, and to adjust the l-thyroxine doses if the TSH has not yet reached the target     range. At the 24-week visit (end of study), the subjects will undergo the same tests that     they had on the baseline visit.      Results from the study will be examined to see if minor changes in TSH or other thyroid     hormone levels cause changes in any of the outcomes, and if the degree of TSH change     correlates with the degree of outcome changes. These results may help physicians caring for     patients with thyroid disease better determine the optimal dose of thyroid hormone for each     patient.   "
208086|NCT00565877|"     Insertion of peripherally inserted central catheters (PICCs) at the bedside may result in tip     malposition. This study was designed to evaluate whether the addition of ultrasound (US)     inspection of the ipsilateral neck provides immediate recognition of PICCs in aberrant     position facilitating catheter reposition prior to completion of the procedure.   "
208087|NCT00565890|"     In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical     trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first     month of age is conducted.   "
208088|NCT00565903|"     Pleuropulmonary Blastoma (PPB) is a rare lung tumor which develops in childhood. The     underlying genetic factors which contribute to the development and progression of PPB are not     defined. We are working to identify the genetic factors which may contribute to the     development of this rare tumor.   "
208089|NCT00565916|"     Estrogen and progesterone are two main female sex hormones. When a woman goes through     menopause, the body's production of estrogen and progesterone significantly decreases. Recent     studies have shown that the breakdown of fatty acids in cardiac muscle is important in     maintaining a healthy heart, and that estrogen may enhance this process. Also, cardiovascular     disease (CVD) occurs more frequently in postmenopausal women than in premenopausal women.     This study will determine in postmenopausal women whether estrogen increases the heart's     ability to use fats as energy and whether progesterone decreases this effect.   "
208090|NCT00565929|"     The purpose of this study is to compare how the body's immune system reacts to a vaccine     against smallpox infection, called Modified Vaccinia Ankara (MVA) and to evaluate the safety     of this vaccine. Study participants will include 24 adults, ages 18-60 years, who have     undergone a stem cell transplant more than 2 years ago. Study procedures will include a     physical exam, blood samples, heart activity assessments, and urine samples. Participants     will be assigned to 1 of 2 possible study vaccine groups. The participants will receive 1 of     2 possible vaccine doses or placebo (substance containing no medication) 28 days apart.     Participants will make at least 8 visits to the clinic during the course of the study;     additional visits may be needed if the participant experiences side effects from the vaccine.     Participants may be involved in study related procedures for about 6 months.   "
208091|NCT00565942|"     Research over the last years have reported an increased popularity of complementary therapies     (CTs) and an integration of CTs into mainstream medical settings, health care organizations     and insurance plans. These trends may present both new challenges and new opportunities for     health care provision. In Sweden and elsewhere, major challenges include the great variety     and quality of CT provision within health care and a lack of national and international     recommendations of how integrations of CTs with conventional care should be modelled, i.e.     lack of conceptual models for delivering integrative medicine (IM). This may partly be a     result of a scarce evidence base in support of IM provision within public health care     services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains     largely unknown whether comprehensive models of IM are clinically or cost effectively     different from conventional care provision.      Back and neck pain are costly, conventionally managed in primary care and two of the most     common conditions treated by CTs. We have developed a comprehensive collaborative consensus     model for IM adapted to Swedish primary care. The aim of this pilot study is to explore if     the developed IM model will help patients with back/neck pain better than usual primary care     management, i.e. to test the hypothesis that IM would be more effective than treatment as     usual.   "
208092|NCT00565955|"     Available evidences show a role of oral montelukast in acute asthma. Safety of oral     montelukast is well established in children, as evidenced by use of oral montelukast in long     term management of asthma.      Therefore, the investigators planned this study to see the effect of oral montelukast as add     on therapy to standard treatment in acute moderate to severe asthma in children between 5-15     years of age.      HYPOTHESIS:      Addition of single dose of oral montelukast to standard therapy in acute moderate to severe     asthma in children aged 5-15 years will reduce the modified pulmonary index score to less     than 9 in 90% children compared to 70% in children receiving a placebo.   "
208093|NCT00565968|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as melphalan, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Sorafenib may also make tumor cells more     sensitive to melphalan. Giving sorafenib together with an isolated limb infusion of melphalan     may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when     given together with an isolated limb infusion of melphalan in treating patients with stage     III melanoma of the arm or leg.   "
208107|NCT00571688|"     This study will evaluate the relative effectiveness of risperidone Consta injections     occurring every 2 weeks in contrast to treatment as usual in preventing symptomatic relapse     and rates of rehospitalization or admission into respite care for bipolar patients.      Hypothesis: Risperdal Consta injections every 2 weeks will reduce the number of symptomatic     relapses into mania, hypomania, mixed state, or depression, as shown by key indicators that     include symptomatic relapse, rehospitalizations, emergency or urgent care visits, respite     care, and intensive outpatient treatment as compared to treatment as usual.   "
208095|NCT00571519|"     This is a 26-week, multicenter, randomized, double-blind, placebo and active     comparator-controlled, parallel-group study in subjects with type 2 diabetes currently     sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic     monotherapy. Pioglitazone is used as active comparator. The total duration of a subject's     participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a     26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Subjects     who complete the randomized portion of the study per protocol may have the opportunity to     continue in a long-term extension study of active treatments.   "
208096|NCT00571545|"     We proposed to examine the effect of an aerobic exercise intervention on depression in     persons with Traumatic Brain Injury (TBI). We will compare persons with chronic brain injury     who are assigned to receive the exercise intervention with those in the control group to     determine the effect of exercise on levels of depression and specific symptoms related to     depression including anxiety, pain, sleep, and cognition. In addition, the effect of exercise     on activity, participation level, and quality of life will be examined.      HYPOTHESES:        1. Participation in an aerobic exercise intervention will decrease the severity of          depression in persons with chronic TBI.        2. Participation in an aerobic exercise intervention will lead to improvements in negative          symptoms associated with depression including anxiety, insomnia, pain, and impaired          cognitive functioning.        3. Participation in an aerobic exercise intervention will be related to improvements in          activity and participation for patients with TBI.        4. Participation in an aerobic exercise intervention will lead to improvements in          perceptions of quality of life.   "
208097|NCT00571558|"     This phase I trial studies the side effects and best dose of photodynamic therapy using     aminolevulinic acid in treating patients with oral leukoplakia. Photodynamic therapy uses a     drug, such as aminolevulinic acid, that becomes active when it is exposed to a certain kind     of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using     aminolevulinic acid may be effective against oral leukoplakia.   "
208098|NCT00571571|"     Normal adolescence requires a successful resolution of identity crisis, which results in the     development of satisfying relationships, success in school/work pursuits, and achievement of     personal goals. Adolescents, who do not resolve this crisis, are at high risk for problems in     those areas of functioning. Transference Focused Psychotherapy for Adolescents (TFP-A) is a     treatment that specifically addresses these issues, permitting adolescents to develop     satisfying friendships, more appropriate interactions with authority, and achieve realistic     life goals.      This study will evaluate the application of TFP-A, (a empirically validated treatment for     adults with identity disturbance), to adolescents exhibiting the same behavioral and identity     pathology. Subjects will be females; ages 14-21, with behaviors associated with identity     problems, interpersonal difficulties with teachers, parents and/or peers, and live with their     families. These adolescents will be randomly assigned to one of two treatment cells, TFP-A or     Treatment as Usual (TAU). Subjects in TFP-A will receive weekly individual therapy for six     months. The TAU group will receive standard individual therapy in the Outpatient Department.     Both will receive medication as necessary. All subjects will participate in initial, weekly,     and bi-monthly assessments during the six-month treatment period, and participate in a     naturalistic follow-up study for an additional six months.      Hypothesis:      Adolescents with identity problems as seen in interpersonal, school, and/or family     difficulties in the Transference Focused Psychotherapy for Adolescents (TFP-A) group will     reduce these problem behaviors and improve management of their feelings and moods compared to     adolescents with identity problems in the treatment as usual control group (TAU).   "
208099|NCT00571584|"     This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and     safety of two dose schedules of activated recombinant human factor VII in treatment of joint     bleeds in haemophilia patients with inhibitors.   "
208100|NCT00571597|"     The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial     fibrillation.   "
208101|NCT00571610|"     Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary     sinus.   "
208102|NCT00571623|"     Following current standard-of-care, subjects data (brain pressure) will be recorded for 1     hour and include 10-minutes of data during which the subject recieves chest physiotherapy     (CPT). The hypothesis is that CPT is not harmful to brain pressure.   "
208103|NCT00571636|"     The objective of this randomized, double-blind trial is to compare the efficacy and safety of     2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA     <= 32 weeks in MV:        -  Group A) continuous infusion of Fentanyl + open label boluses of Fentanyl;        -  Group B) continuous infusion of placebo + open label boluses of Fentanyl.   "
208104|NCT00571649|"     This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in     the leg and lung that can occur with patients hospitalized for acute medical illness, and     compare these results with those of the standard enoxaparin dose and duration regimen. The     safety of rivaroxaban will also be studied.   "
208105|NCT00571662|"     This is a continuation of a pilot study which is now regarded as a phase II trial with a plan     to enroll an additional 40 patients (20 related and 20 unrelated donor transplants) with     hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive     regimen with pentostatin and low-dose total body irradiation (TBI) followed by allogeneic     peripheral blood stem cell transplantation (alloPSCT).   "
208147|NCT00573469|"     The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in     Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of     Crohn's disease and quality of life.   "
208108|NCT00571701|"     This is a randomized double blind controlled study to determine if celebrex (celecoxib), a     selective COX-2 inhibitor, can decrease the rate of recurrence in adult and pediatric     patients with recurrent respiratory papillomatosis. All patients will be evaluated for     disease severity at enrollment and at 3 month intervals for 30 months. After randomization,     patients in the early treatment arm will begin celecoxib 6 months after enrollment. The     delayed treatment arm will begin celecoxib 18 months after enrollment. All patients will     receive celecoxib for 1 year. During the time that patients do not receive celecoxib, they     will receive a placebo capsule with the same appearance. Follow-up visits will occur at three     month intervals for the duration of the study.   "
208109|NCT00571714|"     The primary purpose of the study is to compare the safety and effectiveness of standard     treatment for chronic hepatitis C using peginterferon alpha-2a (Pegasys) and ribavirin     (Copegus) to those same medications plus a dietary supplement called betaine when added for     the first 12 weeks of treatment.      Peginterferon alpha-2a (Pegasys) and ribavirin (Copegus) are approved by the FDA (Food and     Drug Administration) for the treatment of chronic hepatitis C.      Betaine is a dietary supplement and occurs naturally in the body. It is not a medication     regulated by the FDA or an approved drug for chronic hepatitis C.   "
208110|NCT00571727|"     Long term study of the effects of dosing with rhIGF-1 on growth   "
208111|NCT00571740|"     RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may     also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more     tumor cells.      PURPOSE: This randomized phase II trial is studying how well giving cetuximab together     bevacizumab works as first-line therapy, followed by combination chemotherapy and bevacizumab     with or without cetuximab as second-line therapy in treating patients with stage IV     colorectal cancer.   "
208112|NCT00571753|"     The study is conducted to compare safety and efficacy of isoniazid administered as an     adjusted dose based on NAT2 (arylamine N-acetyltransferase type 2)genotype and as a standard     dose.      The hypothesis is that the genotype-adjusted dose is superior to the standard dose with     regard to hepatotoxicity and early treatment failure, respectively, in the group of slow and     rapid acetylators of NAT2.   "
208113|NCT00571766|"     The purpose of this study is to evaluate the effects of oral L-Arginine in pregnant women     with chronic hypertension.   "
208114|NCT00571779|"     Feasibility study arm to evaluate the safety of adding the left atrial linear connecting     lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of     performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP)     ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for     patients with permanent or persistent Atrial Fibrillation (AF).   "
208115|NCT00571792|"     To explore potential proteins that may be used to develop novel therapies for COPD. This will     be accomplished by acquiring material from the lower respiratory tract via endobronchial     brushings.   "
208116|NCT00571805|"     Study of varenicline 2.0 mg/day treatment for 2 weeks with smoking test done in laboratory on     Day 8 and a 1 week quit attempt from Day 8-14.   "
208117|NCT00571818|"     The purpose of this study is to understand how the pancreas functions after transplantation     and particularly why high blood sugar levels develop. It will also analyze the effect of the     medicines used to prevent rejection on blood sugar levels.      The hypothesis to be tested is that hyperglycemia more than six months after successful     pancreas transplant results from a defect in insulin secretion, insulin resistance, or both.   "
208118|NCT00571831|"     To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation     of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light     filtering intraocular lens(UV-filtering IOL).   "
208119|NCT00571844|"     This study is an NIH-funded clinical trial conducted at Duke Medical Center evaluating the     effects of the DASH diet alone and combined with a behavioral weight loss program on blood     pressure and various vascular measures. Eligible patients must be unmedicated with blood     pressure values ranging from approximately 130/85 to 159/99. Our primary hypothesis are as     follows: (1) The DASH diet alone and combined with a behavioral weight management program     will result in greater BP reductions than Usual Care controls at the end of the 4 month     treatment period; (2) The DASH diet in combination with a behavioral weight management     program will be more effective in lowering BP than the DASH diet alone; (3) The DASH diet     alone and the DASH diet combined with the behavioral weight management program will result in     greater improvements in cardiac, metabolic, and vascular function compared to the control     condition; and (4) The combined DASH diet and weight management intervention also will be the     most effective treatment in maintaining BP reductions at 1-year follow-up.   "
208120|NCT00571870|"     Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of     premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH)     for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's.      Many years have passed since GnRH antagonists were introduced to prevent premature LH surges     during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist     protocol. Attempts at modifying GnRH antagonist protocols have been made to improve COH     outcomes. However, a meta-analysis of 27 randomized controlled trials, including recent     reports, showed significantly lower clinical ongoing pregnancy rates in the antagonist group.     Thus, additional efforts are needed to identify the optimal stimulation protocols to achieve     better follicular and embryonic development and to improve the pregnancy rates in COH using     GnRH antagonist.      Given the assumption of a detrimental effect of GnRH antagonist on the pregnancy rate, with     current protocols, we hypothesized that a shorter duration of GnRH antagonist administration     might improve outcome.   "
208203|NCT00574223|"     The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in     patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a     double-blind placebo-controlled setting   "
208121|NCT00573131|"     OncoGel is a new experimental drug delivery system that allows the slow continuous release of     paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel) over a long period     of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.      The protocol is directed towards evaluating the efficacy and safety of paclitaxel delivered     as a local, intralesional treatment when used in combination with chemotherapy (cisplatin and     5-FU) and radiation therapy before surgery.   "
208122|NCT00573144|"     The purpose of this study is to determine the efficacy of intravenous human beta natriuretic     peptide (BNP, Nesiritide) as compared to placebo to prevent adverse post acute myocardial     infarction left ventricular remodeling.   "
208123|NCT00573157|"     The purpose of this study is to learn whether atacicept treatment leads to improvement in     kidney function in subjects with active lupus nephritis in combination with mycophenolate     mofetil (MMF) and corticosteroids. The study was sponsored by Merck Serono International;     operational oversight was provided by ZymoGenetics.   "
208124|NCT00573170|"     Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled,     Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus     Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when     administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)   "
208125|NCT00573183|"     The purpose of this study is to determine whether a combined group and individual 12-Step     facilitative (TSF) intervention, Stimulant Abuser Groups to Engage in 12 -Step (STAGE-12),     improves substance -related outcomes.   "
208126|NCT00573196|"     A preliminary study to determine the possibility of using far infrared radiation for the     treatment of the Bipolar Condition   "
208127|NCT00573209|"     A preliminary study to determine the possibility of using far infrared (FIR) radiation to     treat impotency.   "
208128|NCT00573222|"     This is a 3-month non-interventional, observational study on patients with moderate and     severe asthma.   "
208129|NCT00573235|"     The purpose of this study is to review patients with E. coli infections at the University of     Pittsburgh Medical Center (UPMC) from July 1, 2007 to June 30, 2010 to determine if these     infections have arisen in the community rather than in hospitals or nursing homes.   "
208130|NCT00573248|"     Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, impulsivity,     and hyperactivity that are frequently treated with stimulant medications such as Ritalin.     Many people with ADHD smoke. The smoking prevalence rates are estimated to be 40% in adults     with ADHD compared to 20% in the general population. People with ADHD have also more     difficulty to quit smoking. Only 29% of smokers with ADHD quit smoking compared to 48.5% of     smokers in the general population. Nicotine is a stimulant, which may have properties similar     to stimulant medications (e.g., Ritalin) used to treat ADHD. Nicotine may increase attention     and reduce hyperactivity and impulsivity and, thus, may regulate behavior in individuals with     ADHD. Alleviating the symptoms of ADHD and increasing cardiovascular activity through smoking     may mimic the effects of stimulant medications and can be a form of self-medication.      The major objective of the study was to examine the effects of nicotine on ADHD symptoms,     moods, and cardiovascular activity. The study investigated the effects of nicotine patches on     behavioral regulation in adult smokers and nonsmokers with ADHD. Smokers and nonsmokers with     ADHD participated in two conditions: (1) nicotine patch and (2) placebo patch. During each     condition, symptoms, moods, and side effects were assessed for 2 days during waking hours. An     electronic handheld diary, programmed to prompt the participant twice per hour, recorded ADHD     symptoms (e.g., difficulty concentrating, impulsivity, etc.), negative moods (e.g., anger,     stress), and nicotine side effects (nausea, dizziness). Heart rate and blood pressure were     recorded with lightweight ambulatory monitors to indicate cardiovascular activity. Results     provided information about the effects of nicotine patches on behavioral regulation in adult     smokers and nonsmokers with ADHD.      The inclusion of nonsmokers was important to clarify whether the effects of nicotine on     smokers was due to smoking withdrawal. The findings help explain the increased smoking     prevalence rates and reduced quit rates associated with ADHD. Knowledge about nicotine's     effects on behavioral regulation can help to develop successful smoking cessation programs     for individuals with ADHD. The findings on cardiovascular activity may help determine the     potential risk for cardiovascular disease in smokers and nonsmokers with ADHD. The study     contributed to understanding nicotine's effects on behavioral regulation in a highly     vulnerable population such as people with ADHD.   "
208131|NCT00573261|"     This study is designed to examine how pregabalin affects parameters of autonomic nerve     regulation in correlation with change in pain, anxiety, and depressive symptoms in patients     with diabetic neuropathy.   "
208132|NCT00573274|"     Pregnant patients having a cesarean section (CS) under spinal anesthesia experience a variety     of hemodynamic changes, such as hypotension due to decreases in cardiac output (CO), stroke     volume (SV) and/or systemic vascular resistance (SVR). Measurement of these hemodynamic     parameters classically requires insertion of a pulmonary artery catheter (PAC) into the     heart. However, this invasive method carries significant complications and its use is now     reserved for the more critically ill patients. We hypothesize that the Physioflow Impedance     device can be used as a reliable non-invasive monitor to measure hemodynamic parameters     during elective CS under spinal anesthesia.   "
208133|NCT00573287|"     Many individuals with schizophrenia abuse cannabis at the onset of their illness, portending     a poorer course of illness and poorer treatment response. Preliminary evidence suggests that     clozapine may uniquely reduce substance use in patients with schizophrenia. The purpose of     this study is to establish an effective methodology for studying early treatment with     clozapine in patients with co-occurring schizophrenia and cannabis use disorder, while     generating pilot data comparing clozapine vs. risperidone on substance use, psychiatric     symptoms, side effects, and treatment discontinuation.   "
208134|NCT00573300|"     In this pilot study, the investigators propose to characterize the pattern of activation of     the kynurenine pathway of tryptophan metabolism in peripheral macrophages of patients with     schizophrenia. To do this, the investigators will measure the gene expression of several     major enzymes in this pathway in macrophages, including the key enzyme involved in tryptophan     to kynurenine metabolism, IDO, by means of quantitative reverse-transcription polymerase     chain reaction (RT-PCR). The focus on enzyme mRNA expression as opposed to serum or     cerebrospinal fluid levels of metabolites provides a possibly more sensitive characterization     of the activation of this metabolic pathway.   "
208135|NCT00573313|"     Prior studies in animal models have established that the pathogenesis of alcoholic liver     disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic     methionine metabolism. The hypothesis of the clinical study was that provision of the     methionine metabolite S-adenosylmethionine (SAM) would correct abnormal hepatic methionine     metabolism thereby effectively treating ALD. The two goals of the clinical research were a)to     determine the clinical relationship of aberrant hepatic methionine metabolism to ALD by     comparisons of patterns of serum methionine metabolites in groups of ALD patients, alcoholics     without liver disease, and normal healthy subjects, and b) to determine the treatment effects     of SAM on patterns of serum methionine metabolites and on the histopathology and biochemical     features of liver injury in ALD patients.   "
208136|NCT00573326|"     The purpose of this study is to verify effect and tolerability of imatinib on pulmonary and     skin fibrosis in patients affected by systemic sclerosis.   "
208148|NCT00573482|"     The dramatic rise in overweight and obesity during the past several decades can be explained     by environmental changes that foster increased energy intake and decreased energy     expenditure. There are several reasons to suggest that the most effective approach to weight     gain prevention is the incorporate reduced-fat eating into an overall strategy of lowering     the energy density of the diet. Our energy density manipulations will be designed to reduce     both the fat content and the caloric density of foods served at a cafeteria, which serves as     the food environment for hospital employees.   "
208190|NCT00574054|"     This trial is a preliminary study to determine the use of far infrared radiation for the     treatment of dementia and other mental sickness.   "
208137|NCT00573339|"     The purpose of this research is to understand how to apply cardiac magnetic resonance imaging     (CMR) to women with small artery heart disease by looking at the CMRs of women without heart     disease. The investigators will study 40 women with no heart disease to learn more about the     usefulness of CMR.      Women suffer more than men from this disorder of the small vessels compared to the large     vessels. This results in delays in diagnosis, missed opportunities for treatment, and likely     contributes to the increased death rate from heart disease in women compared to men. Current     testing for small vessel disease is invasive and not performed routinely and women are often     not initiated on appropriate lifesaving treatment. New imaging and noninvasive technology     exists that may improve this situation. Imaging techniques such as cardiac magnetic resonance     imaging (CMR) can now show the inner layers of the heart where the small vessel abnormality     and myocardial ischemia exist. These techniques, while promising, have not been tested to     determine if they can be used to diagnose and treat the small vessel coronary heart disease     condition. They also have not been studied extensively in women without heart disease.      Gadolinium, the contrast agent that will be given Intravenously to all study participants     during the cardiac MRI procedure, is contraindicated to patients with renal impairment. Even     though it will only be given once to each of our patients, the investigators still wanted to     establish the fact that these study participants have normal or good renal functioning by     doing BUN and Creatinine blood tests prior to the administration of this contrast agent to     their system. By adding these lab tests, the investigators will be more cautious to the     well-being and safety of the study participants.      The investigators will be recruiting women aged 35-65 years with no known heart disease or     heart disease risk factors like high blood pressure or high cholesterol. Participants will     discuss the cardiac magnetic resonance procedure with a research doctor and if they agree,     will fill out questionnaires related to their health, have blood draw and then undergo the     CMR procedure. This can be completed in 1 or 2 visits. No follow up is needed.   "
208138|NCT00573352|"     A study to evaluate the possibility of using far infrared radiation to manage pain due to     osteoarthritis.   "
208139|NCT00573365|"     Radiation dermatitis is a common side-effect of radiation therapy in cancer patients who     frequently can experience redness, pain, crusting, and even ulceration of the skin causing     suffering and treatment interruption. A recent retrospective study by DeLand demonstrated     that administering light emitting diode (LED) photomodulation after each radiation treatment     for breast cancer decreased radiation dermatitis in a majority of patients. LED     photomodulation is a process by which specific sequences of light are used to regulate or     manipulate cell activity without causing heat or damage to the skin. Each LED treatment is     painless and is completed in usually less than one minute. LED photomodulation may reduce the     suffering associated with radiation treatments, improve cosmetic outcome in radiation fields,     and eliminate breaks in radiation treatments which may be required because of severe     ulcerating reactions.      This study will attempt to replicate the findings of Dr. DeLand's study by randomly assigning     at least 40 breast cancer patients to either a treatment group or to a control group. The     treatment group will receive LED photomodulation treatments before and after each radiation     treatment with the Gentlewaves Select™ handheld high energy 590nm LED array using specific     sequences of pulses used in other studies; the treatment group will also receive 7 additional     treatments over 2 weeks after their radiation treatment course is completed. The control     group will receive no LED treatment but will use the exact same skin care regimen as the     treatment group. In addition to weekly evaluation and grading of skin reactions, subjects     will be photographed under standardized conditions weekly and then photographs will be     evaluated and graded by blinded dermatologists.   "
208140|NCT00573378|"     To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have     achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be     treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b     (PEG-IFN-a2b, [IFN]) for 2 years, subsequently have their therapy discontinued, and then     maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1     year after discontinuation of the TKI and IFN will be the measurement of this objective.   "
208141|NCT00573391|"     This study is being done to find out if the combination of VelcadeTM with melphalan and     dexamethasone (VMD) will be as effective, or even more effective as it is in combination with     thalidomide and dexamethasone (VTD).   "
208142|NCT00573404|"     RATIONALE: Imatinib mesylate and sunitinib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate     given together with sunitinib in treating patients with gastrointestinal stromal tumors.   "
208143|NCT00573417|"     This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating     dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of     clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be     initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4     weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based     upon persistence of sedation versus emergence of side effects.   "
208144|NCT00573430|"     To determine the effective dose of candesartan cilexetil for reduction of urinary protein     excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline     urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in     urinary protein/creatinine ratio from baseline to the end of 28-week treatment   "
208145|NCT00573443|"     Objectives of the study are to evaluate the safety, tolerability, and efficacy of two     different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide     and 10 mg of quinidine sulfate [AVP-923-30] or 20 mg of dextromethorphan hydrobromide and 10     mg of quinidine sulfate [AVP-923-20]) when compared to placebo, for the treatment of PBA in a     population of patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS)     over a 12-week period. An additional objective is to determine the pharmacokinetic parameters     of the two different doses of AVP-923 in a subset of the study population.      Pseudobulbar Affect (PBA) is a condition characterized by involuntary, sudden and frequent     episodes of laughing and/or crying out of proportion or incongruous to the underlying emotion     of happiness or sadness Other terms used to describe this condition include emotional     lability, emotionalism, emotional incontinence, emotional discontrol, excessive emotionalism,     and pathological laughing and crying. The outbursts can occur spontaneously or in response to     provocative stimuli such as questions or events.      A body of evidence suggests that PBA can be modulated through pharmacologic intervention.      Dextromethorphan (DM) is a low-affinity uncompetitive antagonist of the N-Methyl-D-aspartate     (NMDA) receptor, reducing the level of excitatory activity. DM also acts at the     phencyclidine-binding site, which is part of the NMDA receptor complex. DM is a sigma     receptor agonist, suppressing the release of excitatory neurotransmitters.      Quinidine (Q) is a known potent inhibitor of cytochrome P450 2D6 (CYP2D6), that decreases the     metabolism of dextromethorphan and helps to achieve sustained and therapeutic levels of this     drug.   "
208146|NCT00573456|"     A study to determine the use of far infrared (FIR) radiation for treatment of diabetes.   "
208149|NCT00573495|"     This is a study on how to activate the immune system with a vaccine. The vaccine is made up     of two proteins found in breast cancer: telomerase and survivin. The vaccine is given in     combination with other drugs that may also have an effect on the immune system and attack the     cancer.      The goals of the study are:        1. to test the safety of the combination of agents        2. to find out what effects the treatment has on advanced breast cancer   "
208150|NCT00573508|"     Evaluate the effect of VESIcare® on symptom bother for subjects with OAB   "
208151|NCT00573521|"     This research will be conducted to determine whether risk factors exist for     piperacillin/tazobactam resistance in ESBL organisms.   "
208152|NCT00573534|"     This is an open label pilot study to obtain information on the best way to study young     adolescents with Attention Deficit Hyperactivity Disorder (ADHD)who may also be at risk of     developing substance abuse, in part because of their ADHD. The plan is to recruit older     children/young adolescents (age 11-15) who have ADHD and also have an older sibling with     substance abuse. The treatment for ADHD in the 11-15 year old will be Vyvanse, a novel     preparation of dextroamphetamine in which the molecule is inactivated and only becomes     activated when it is digested. This preparation is felt to be safer from diversion while at     the same time providing treatment for the younger siblings in which a bad outcome has already     occurred in the family, namely the older sibling's substance abuse. As mentioned, this is an     open-label study, a feasibility study to see if we can use this approach to study and treat     high risk youth before they develop substance abuse.   "
208153|NCT00573547|"     The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in     depression in patients requiring kidney dialysis.   "
208154|NCT00573560|"     The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the     malfunctioning portion of the left ventricle in patients with symptoms of heart failure due     to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it     is hypothesized that the left ventricle will pump more effectively.   "
208155|NCT00573573|"     A study to determine the possibility of using far infrared radiation to treat     Hyperparathyroidism.   "
208156|NCT00573586|"     This is an investigational study on the use of high intensity focused ultrasound (HIFU) in     the management of localized prostate cancer (T1c/T2a) as a primary non-comparative study.      High intensity focused ultrasound (HIFU) is a non-invasive acoustic ablation technique that     uses intersecting, precision focused ultrasound waves to raise the temperature of the target     to) 80-90 degrees C in 2-3 seconds, destroying the targeted tissues (prostate cancer). The     tissue targeting is highly precise, minimizing collateral damage.      The overall hypothesis is that HIFU with Sonablate can safely, effectively and selectively     ablate prostate cancer tissue, resulting in complete tissue necrosis, in patients diagnosed     with localized T1c/T2a prostate cancer, with minimal morbidity.      The specific hypothesis is that the Sonablate has the ability to:        -  Completely destroy prostate cancer tissue, without causing damage to the intervening          tissue, with a drop in PSA levels to <0.5ng/ml.        -  Result in negative biopsies for evidence of viable malignant cells after the treatment          (12 months if Nadir is not reached or PSA rises from Nadir)        -  Safely treat localized prostate cancer patients, with minimal and acceptable adverse          effects   "
208157|NCT00573599|"     ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR     imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is     improvement in pain scales between the groups.   "
208158|NCT00573612|"     Fibromyalgia (FMS), defined as the presence of both chronic widespread pain and the finding     of 11/18 tender points on examination, affects 2% of the general population. Drug therapy for     FMS is largely symptomatic as there is not yet a complete understanding of the pathogenesis     of the disease. In the past 17 years, supervised aerobic exercise has emerged as an important     treatment modality to improve pain, aerobic capacity, function, and well-being. Individuals     who are able to adhere to exercise almost always maintain the symptomatic benefits of     exercise. Unfortunately, the rate of exercise adherence six months after the completion of a     well-structured supervised exercise program is disappointingly low. Furthermore, although the     efficacy of supervised aerobic exercise in the research setting is well documented, the     applicability of such intervention in the clinic setting is doubtful. Therefore, we propose     to conduct the Research to Encourage Exercise for Fibromyalgia (REEF), a randomized     attention-controlled trial whose primary aim is to evaluate the efficacy of     telephone-delivered motivational interviewing (MI) to encourage exercise, in improving     exercise adherence and self-report physical function (co-primary outcome measures) for FMS     patients. REEF will enroll 200 FMS patients, randomizing them to either the MI group or the     attention-control (AC) group. Participants from each group will receive a total of 6     telephone calls within a 12-week period. Prior to the phone calls, participants from both     groups will receive an individualized exercise prescription and 2 supervised exercise     training sessions to get them started on an exercise program. All subjects will undergo     comprehensive outcome assessment at baseline, week 12, week 24, and week 36. The secondary     aim of this proposal is to determine the mediators between MI and improvement in self-report     physical function. The proposed research is significant because our focus is the promotion of     adherence to an exercise program, of adequate intensity, in order to maximize functioning and     well-being for patients with FMS. The use of a predominantly home-based exercise program and     telephone-delivered MI by a trained licensed practice nurse (LPN) could potentially make the     proposed intervention more accessible to the greater majority of FMS patients. Furthermore,     if proven efficacious, MI could readily be applied to other chronically painful conditions     (e.g. chronic back pain).   "
208159|NCT00573638|"     The study hypothesis is that the Xal-Ease with increase patient compliance with XALATAN   "
208160|NCT00573651|"     The purpose of this research study is to see if patients with juvenile idiopathic arthritis     or seronegative arthritis (and related conditions) mount protective immune responses to the     human papillomavirus (HPV) vaccine called Gardasil. The researchers also want to monitor for     any increase in disease activity following receipt of the vaccine.   "
208161|NCT00573664|"     The purpose of this study is to determine whether a single dose of gabapentin, given before     cesarean section, will reduce pain in the initial 24 hours after surgery. Gabapentin has been     very effective at treating pain after knee and hip operations, hysterectomies, and many other     types of surgeries. We believe that it may be effective for treating pain after cesarean     sections, but it has never been studied for this purpose.   "
208162|NCT00573690|"     RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by     blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, etoposide,     and carboplatin, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving sorafenib together with cisplatin and     etoposide or carboplatin and pemetrexed may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when     given together with cisplatin and etoposide or carboplatin and pemetrexed in treating     patients with metastatic solid tumors.   "
208163|NCT00573703|"     Transobturatory tape (TOT) procedure is a minimally invasive approach to urinary stress     incontinence owing to the category of the sling-adopting procedures. Its efficacy and safety,     also in comparison with similar procedures have been demonstrated. The benefits of the sling-     adopting procedures in comparison to laparoscopic Burch colposuspension, which has been     considered as the gold standard treatment, have been showed. But these comparisons did not     included the TOT procedure in the experimental arms. Based on this considerations the aim of     this trial will be to compare TOT and laparoscopic Burch colposuspension in women with     urinary stress incontinence.   "
208164|NCT00573716|"     This study examines if the use of antipsychotic medications might contribute to an     interruption in bone mineral development and/or a reduction in bone mineral content in     adolescents.   "
208165|NCT00573729|"     Port wine stain are a congenital, progressive vascular malformation of human skin. The pulsed     dye laser is approved by the Food and Drug Administration for the treatment of choice.     However, the degree of port wine stain blanching seen following pulsed dye laser treatment     remains variable and unpredictable. If the ultimate standard required is complete lesion     blanching, the average success rate is below 10%, even after undergoing numerous pulsed dye     laser treatments. Moreover, less than 50% of patients achieve 50% fading of their Port wine     stain in response to pulsed dye laser therapy.   "
208166|NCT00573742|"     The purpose of this study is to observe treatment with candesartan cilexetil 16mg for 8     weeks, in uncontrolled hypertensive patients, in improvement of achieving of treatment goals     and impact on blood pressure level in patients with uncontrolled hypertension treated with     candesartan cilexetil.   "
208167|NCT00573755|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor     and by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of     breast cancer cells. Aromatase inhibition therapy using letrozole, anastrozole, or exemestane     may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet     known whether sorafenib is more effective than a placebo when given together with letrozole,     anastrozole, or exemestane in treating metastatic breast cancer.      PURPOSE: This randomized phase II trial is studying how well sorafenib works compared with a     placebo when given together with letrozole, anastrozole, or exemestane in treating     postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive     metastatic breast cancer.   "
208168|NCT00573768|"     This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment     of acute ankle sprain.   "
208169|NCT00573781|"     Professor Matti Uusitupa, University of Kuopio, Department of Clinical Nutrition (www.uku.fi)     Docent Matej Oresic, VTT (www.vtt.fi) Ursula Schwab, PhD, Docent, Marjukka Kolehmainen, PhD,     Docent, Leena Pulkkinen, PhD, Docent, David Laaksonen, MD, PhD, MPH, Docent, Kaisa Poutanen,     DSc (Tech), Research Professor      ABSTRACT      The metabolic syndrome (MS) and type 2 diabetes (T2DM) are the most important health problems     worldwide. In Finland the prevalence of T2DM is 12-15% among middle-aged people. The     prevalence of less marked disturbances in glucose metabolism and MS is 30-40%. Because MS and     T2DM are important risk factors for cardiovascular diseases (CVD), the leading cause of death     in western countries, all efforts to reverse the epidemic increase in the incidence of MS and     T2DM are warranted. The investigators have focused for years on the prevention and     non-pharmacological treatment of T2DM and its complications including studies on genetic     regulation of glucose and lipid metabolism after dietary modifications. In the investigators'     recent projects, the investigators have studied the effects of long-term dietary     interventions on gene expression profiles of fat tissue in subjects who are at risk of T2DM.     The ultimate goal of these projects has been to identify genes and gene clusters and their     biological pathways that respond to dietary modification and modulate glucose and lipid     metabolism, and to develop dietary strategies for prevention of T2DM. The main goal of this     project is to find nutrition related early biomarkers for progression of MS to T2DM by using     modern technologies of systems biology (transcriptomics, metabolomics) of carefully conducted     dietary interventions involving subjects with MS. The data will be analysed by using     bioinformatics. The investigators reflect these new data to well-known risk factors for T2DM     and CVD, e.g., insulin sensitivity, insulin secretion, serum lipids and inflammatory factors     among others. In addition to interventions conducted earlier, a new intervention with a whole     grain-berry-fish diet and a whole grain diet compared to a control diet with refined foods     will be performed. The aim is to increase the investigators' understanding on the synergistic     effects of these foods, because the investigators' previous interventions have shown that     these individual foods have beneficial effects on glucose and lipid metabolism. On the     contrary, diets with refined foods may be harmful in long-term due to its high insulin     response, which may through chronic stress lead to both insulin resistance and beta-cell     damage.      The significance of this project is to increase understanding of the pathophysiology of MS,     T2DM and CVD in physiological, cellular and genetic systems, which may lead to more effective     and individualised strategies for treatment and prevention, and better identification of     high-risk individuals responsive to specific dietary modifications. Increasing knowledge of     dietary factors involved in the progression of MS to T2DM and CVD offers new opportunities to     individually tailored diets in the management and prevention of these disorders. The results     will also be beneficial for the food industry in developing new functional foods. These     results and actions may help delay or even stop the epidemic of MS and T2DM and their     negative effect on public health currently seen in Finland and worldwide.   "
208170|NCT00573794|"     To assess the long-term safety and maintenance of response of adalimumab in subjects with     ulcerative colitis.   "
208171|NCT00573807|"     A preliminary study to determine the use of far infrared radiation for the treatment of back     pain   "
208172|NCT00573820|"     A study to determine the use of far infrared radiation for the treatment of prostate cancer.   "
208173|NCT00573833|"     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near     a tumor to kill tumor cells.      PURPOSE: This clinical trial is studying the side effects and how well internal radiation     therapy works in treating patients with prostate cancer.   "
208174|NCT00573846|"     This is a retrospective, case control study of inflammatory bowel disease. This study will     analyze the phenotypic characteristics of inflammatory bowel disease in the Southeast Asian     population and will help describe clinical characteristics and serologic profiles in     Southeast Asians with inflammatory bowel disease, comparing the phenotype differences to     historical Caucasian controls. The data from this study will help identify the phenotype     characteristics of different ethnic groups and study the epidemiological patterns of the     disease.   "
208175|NCT00573859|"     Whereas the smoking prevalence rates in the general population are declining, rates among     people diagnosed with attention-deficit hyperactivity disorder (ADHD) continue to be     elevated. Smoking may be a form of self-medication in people with ADHD, which has specific     reinforcing mechanisms such as improvement of ADHD core symptoms, enhancement of moods and     arousal, or a combination of both. In addition, the reinforcing effects of smoking may be     potentiated by stimulant medication.      The study examined the reinforcing effects of ad libitum smoking with and without ADHD     medication in adult smokers with clinically diagnosed ADHD. Participants were adults with     ADHD. The effects of two day of ADHD medication compared to two days on placebo for were     studied on nicotine intake (i.e., cotinine levels). In addition, task performance on the     Continuous Performance Task and nicotine withdrawal symptoms were examined in response to     ADHD medication + smoking a cigarette versus ADHD medication + abstinence versus placebo     medication + smoking versus placebo medication + abstinence.      The study identified the reinforcing mechanisms of smoking in interaction with ADHD     medication. The findings will contribute to a better understanding of nicotine addiction and     facilitate the development of targeted smoking cessation and prevention programs for     individuals with ADHD and other people with deficiencies in impulse control and excessive     risk taking.   "
208176|NCT00573872|"     Phase I of the study (motion and quality assurance [QA] study) is being used to determine     intrafraction target motion and define quality assurance procedures for single fraction     spinal radiosurgery. The Phase II portion of the study is being used to estimate the     palliative response (pain or relief of neurologic symptoms) and local control for single     fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of     spinal radiosurgery.   "
208177|NCT00573885|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Green tea     extract may keep cancer from forming.      PURPOSE: This randomized phase II trial is studying green tea extract in preventing cancer in     former and current heavy smokers with abnormal sputum.   "
208188|NCT00574028|"     The objective and aims of this study is to develop The University of California Irvine     Medical Center Inflammatory Bowel Disease Research Registry for the purpose of:        1. Performance of retrospective studies on inflammatory bowel disease to assess disease          outcomes and response to therapy.        2. Obtaining permission from the Research Registry participants to be contacted by members          of The University of California Irvine Medical Center Inflammatory Bowel Disease          Research Center to identify patients that may be eligible for participation in future          research studies.        3. Performance of studies to quantify disease phenotypes and treatment patterns.   "
208178|NCT00573898|"     This will be a prospective, multicenter, open-labeled, non-comparative pharmacokinetic study     conducted in 10 critically ill, anuric patients receiving CVVHDF. Enrollment will take place     at 3-5 clinical sites in the United States. A study coordinator at each site will be     identified and institutional specific processes (e.g., pharmacy records, etc.) will be     utilized to identify patients. Full evaluation of inclusion and exclusion criteria will be     conducted by each site's coordinator within 48 hours of initiation of daptomycin therapy.     Subjects receiving daptomycin 6mg/kg (total body weight) once daily for a     suspected/documented infection, as deemed necessary by the treating clinician will be     screened for inclusion in the current study. Dialysate, ultrafiltrate, and blood flow rate     utilized during the CVVHDF procedure will be determined by clinicians at discretion to     optimize stability of patients.      Daptomycin samples will be obtained around the third dose in an attempt to achieve     approximate steady-state concentrations. Pre- and post-filter blood samples will be collected     simultaneously with dialysate and ultrafiltrate specimens at multiple time points. Protein     binding will be assessed by filtration of the serum samples at the peak drug concentration     time points.   "
208179|NCT00573911|"     Patients with Barrett's Esophagus are known to have excessive distal esophageal acid exposure     comparable to patients with erosive esophagitis. A significant proportion of patients with BE     who are not symptomatic on treatment continue to have persistent acid reflux. High dose     esomeprazole is able to control acid reflux in patients with BE. The effect of acid reflux on     Barrett's esophagus stroma is currently unknown.      It is our hypothesis that stromal fibroblast activation in Barrett's esophagus is influenced     by acid reflux. The specific aim of this proposal will be: To assess the association between     acid reflux and subepithelial fibroblasts in Barrett's esophagus.   "
208180|NCT00573924|"     Patients with bleeding ulcers identified by endoscopy will be randomly assigned to receive an     acid-blocking drug (called a proton pump inhibitor [PPI]) either by mouth every 3 hours for     24 hours or intravenously (IV) by constant infusion for 24 hours. A pH probe in the stomach     will be used to determine intragastric pH (a measure of the acid production in the stomach)     at baseline and during the 24 hours of therapy. The purpose of the study is to determine if     the continuous intravenous administration of the drug provides better reduction of acid in     the stomach than the oral administration.   "
208181|NCT00573937|"     The purpose of this study is to compare methadone with morphine in the management of moderate     to severe cancer pain.   "
208182|NCT00573950|"     Cilostazol is an antiplatelet agent used to reduce the symptoms of intermittent claudication.     Cilostazol inhibits phosphodiesterase III (PDE III), which causes it to be a vasodilator and     inhibitor of platelet aggregation. Recently there were report of beneficial effect of     cilostazol like vasodilation, lipid metabolism, and cytokine production. But there were few     clinical studies that support these effects of cilostazol. The purpose of this study is to     evaluate the vasodilatory and anti-inflammatory effect of cilostazol presented by PWV and     plasma adipocytokines.   "
208183|NCT00573963|"     The purpose of this study is to determine if patients having the transversus abdominal place     (TAP) block at the end of a cesarean delivery have less pain in the post-delivery period than     those who do not. Freezing medication is injected between the layers of muscle on either side     of the belly, to freeze the nerves that carry pain stimuli from an abdominal wound. This     technique has been useful for many abdominal operations, and has recently been studied in     cesarean sections, however more information is needed.   "
208184|NCT00573976|"     In the past two decades there have been great strides made in understanding the biological     changes resulting from spinal cord injury (SCI). The future holds promise of the development     of therapies that will promote degrees of repair and recovery of function for people living     with SCI. Lessons learned from past failed SCI clinical trials, however, demonstrate that,     in order to accurately evaluate the overall effectiveness of SCI therapies, more sensitive     outcomes measures are needed. Specifically, and reflecting the ultimate goal of clinical     interventions - inducing functional recovery - the Spinal Cord Independence Measure (SCIM),     has been recommended for further testing and development for use as a measure of functional     ability in future SCI clinical studies. The SCIM is a very simple questionnaire and score     sheet that an evaluator uses to determine how independently a person with SCI can perform     certain tasks.      A panel of SCI researchers recommended the SCIM as the most suitable among four candidate     measures of functional recovery reviewed at a special meeting sponsored by the National     Institute on Disability and Rehabilitation Research (NIDRR) at a joint meeting of the     American Spinal Injury Association and the International Spinal Cord Society (ASIA-ISCoS) in     Boston, MA, in June 2006. It was recommended that a large-scale, multi-center, prospective     trial be conducted in the United States, which would mirror a recently published multi-site     international study.      The proposed research on the SCIM III, the latest and most sensitive version of the SCIM,     would test the hypothesis that the SCIM III is a valid, reliable, and sensitive measure of     functional ability in persons with SCI. Twenty-two rehabilitation centers throughout the     United States will enroll a maximum of 660 subjects. Functional ability will be measured with     the SCIM III during the first week of admittance into inpatient acute rehabilitation and     within one week of discharge from the same rehabilitation program. Statistical analyses will     be used to test the validity, reliability, and sensitivity of the SCIM III. The results will     demonstrate whether the SCIM III is a suitable outcome measure to assess SCI specific     functional ability in future clinical trials.   "
208185|NCT00573989|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as     pemetrexed and erlotinib, may make tumor cells more sensitive to radiation therapy. Erlotinib     and pemetrexed may also stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Giving intensity-modulated radiation therapy together with pemetrexed and     erlotinib may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when     given together with intensity-modulated radiation therapy and pemetrexed and to see how well     they work in treating patients with recurrent or second primary head and neck cancer.   "
208186|NCT00574002|"     The purpose of the study is to evaluate a safe threshold for when to remove chest tubes in     patients based on the amount of drainage present.   "
208187|NCT00574015|"     This study will compare the degree of pain control provided by two techniques for persons     with toothache in an emergency department. The two techniques include;        -  standard oral narcotic pain medication        -  numbing the tooth with local anesthetic by needle injection   "
208204|NCT00574236|"     Primary objective is to determine the effectiveness of the combination of bortezomib and     doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase     II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with     doxorubicin IV on days 1 and 8 of a 21-day cycle.   "
208205|NCT00574249|"     The objective of this study is to assess the efficacy and safety of adalimumab in combination     with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination     with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.   "
208191|NCT00574067|"     This five-year study examines the effectiveness of buprenorphine treatment provided to     previously-addicted inmates(N=320; 160 males, 160 females) initiated in prison and continued     in the community. The study also examines the extent to which the setting of post-release     buprenorphine is provided.It is expected that participants receiving in-prison buprenorphine     will have superior outcomes compared to participants who did not receive in-prison     buprenorphine.   "
208192|NCT00574080|"     Add three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose     chemotherapy regimen immediately before transplant (DPACE/Melphalan) to try to improve     myeloma response and acquire longer survival for participants.   "
208193|NCT00574093|"     This study is designed to evaluate the effect of Visudyne® combination therapy (Visudyne®     [verteporfin for injection] and Lucentis™) on visual acuity outcomes. Study results will be     submitted for publication to provide data that may help physicians refine the clinical     management of patients with CNV secondary to age-related macular degeneration (AMD).   "
208194|NCT00574106|"     Cancer is the number one killer in Canada and in most countries of the world. The     investigators' initial assessment indicates that far infrared radiation has the potential to     cure cancer.   "
208195|NCT00574119|"     We plan to study the concept of energy starvation in heart failure by evaluation of     patients with nonischemic dilated cardiomyopathy (NIDCM) (heart failure with reduced heart     pump function due to causes other than heart attack). We will use a combination of positron     emission tomography and magnetic resonance imaging to study metabolism, anatomy, function,     blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone     which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart     muscle).   "
208196|NCT00574132|"     This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose     study in male and female patients ages 50 to less than 89 years with mild to moderate AD.     Approximately 230 study sites in the US and Canada and up to 35 sites outside of North     America will be involved. Patients will be randomized to receive either bapineuzumab or     placebo. Each patient's participation will last approximately 1.5 years.      Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid     peptide, and is designed to provide antibodies to beta amyloid directly to the patient.   "
208197|NCT00574145|"     RATIONALE: Healing touch therapy may be effective in lessening fatigue in women with breast     cancer who are undergoing radiation therapy.      PURPOSE: This randomized clinical trial is studying how well healing touch works in treating     fatigue in women undergoing radiation therapy for breast cancer.   "
208198|NCT00574158|"     The goals of the research are designed to accomplish genetic association studies of candidate     genes in healthy normal individuals exposed to 0.2 ppm for 2.25 hours with intermittent     exercise in order to search for associations between defined genotypes/haplotypes and 3     specific in vivo respiratory endpoints: a) change in FEV1 immediately after ozone exposure;     b) change nonspecific bronchial reactivity as reflected in the change in methacholine PC20     FEV1 24 hours after ozone exposure ; and c) change in lung epithelial integrity as reflected     in the Clearance Halftime of technetium 24 hours after ozone exposure. These studies have     been carried forward to take place in 4 phases:      i) healthy individuals have been exposed to O3 using our standard exposure protocol; and we     will increase the numbers of individuals available for study.      ii) perform genetic association studies for the endpoints of spirometry (FEV1, FVC,     FEV1/FVC), PC20 FEV1 for methacholine, and epithelial integrity (Clearance Halftime) for 3     candidate O3 response genes taken from literature searches and/or previously characterized to     demonstrate associations. These physiologic endpoints have been examined in terms of both a     continuum of response, and discrete responder and non-responder endpoints.   "
208199|NCT00574171|"     The purpose of this study is to find out how effective this combination is as a second line     treatment for colorectal cancer that has spread from one part of the body to another     (metastasized) or has not metastasized but is considered inoperable (unable to be removed by     surgery). The side effects and survival experienced by subjects receiving these drugs will     also be evaluated. This is a phase II research study.   "
208200|NCT00574184|"     The specific aim of this pilot study is to describe the angiographic prevalence and pattern     of internal pudendal artery (and associated inflow vessel) atherosclerosis in patients with     erectile dysfunction who are non-responsive to PDE-5 inhibitors (i.e., Viagra) who are     referred for clinically-indicated cardiac catheterization.   "
208201|NCT00574197|"     Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of     mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of     transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of     Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of     acute kidney rejection only. There is no clinical data of its use in heart transplant     patients.   "
208202|NCT00574210|"     The purpose of this study is to evaluate the relative efficacy of four dosing regimens of     bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen     using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores     (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history     of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two     ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months     prior to randomization.   "
208207|NCT00574275|"     The main objective of the study was to evaluate the effectiveness of aflibercept treatment by     comparison to placebo in increasing the overall survival (OS) in participants with metastatic     pancreatic cancer, treated with gemcitabine.      The secondary objectives were to evaluate progression free survival, clinical benefit,     overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1:     Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine).      The study included an interim analysis of OS. In accordance with the study protocol, an     interim analysis was performed for the purpose of futility and overwhelming efficacy. On the     basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this     study be terminated for futility based on predefined boundary rules.   "
208208|NCT00574288|"     Establishment of safety profile of HuMax-CD38 when given as monotherapy in participants with     multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies     and without further established treatment options.   "
208209|NCT00574301|"     We hypothesize that radiofrequency ablation after single-insertion image guided vacuum     assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast     cancers (≤1.5 cm).   "
208210|NCT00574314|"     Women have been disproportionately underrepresented in clinical research. Few of the many     drugs approved by the FDA have been adequately tested in women. Most common health conditions     experienced by both women and men are managed by treatments that have been developed and     tested most in men.      A new barrier to enrolling women in clinical trials is in effect: HIPAA (the Health Insurance     Portability and Accountability Act). The positive benefit of HIPAA—protecting a person's     health information from abuse—is laudable, but it comes at a cost: it will deny investigators     the benefit of access to chart (medical record) review in order to gather data to answer     clinical questions. In the past, investigators were allowed access to patient's charts     because the hospital consent form included a clause indicating that the patient's information     may be used for research.      The investigators propose to overcome this crisis and challenge with a proven method of     identifying individuals who would be willing to consider participating in a clinical trial:     The Women's Guild Health Research Registry. In keeping with the focus of the Women's Health     Program, we would propose to enroll only women. The registry will allow qualified     investigators to identify potential study participants. This idea has been effective at     improving the quantity and quality of women able and willing to participate in trials.      The investigators will also allow other approved sites to utilize the Registry via the     approved procedure of submitting an IRB approved protocol which will be reviewed by our     Internal Review Committee. This protocol's inclusion/exclusion criteria will be used to query     the database for eligible participants. The participants will be contacted by the Registry     staff to ascertain their interest in this research protocol and their agreement to release     their contact data to the investigator will be obtained.      Investigators will be charged at the time they approach the registry for assistance. The     charge is intended to cover the cost of maintaining the registry now that initial funding has     been exhausted.   "
208211|NCT00574327|"     The purpose of this study is to determine or evaluate the risk factors such as smoking,     family history etc. that cause esophageal cancer and to determine the genetic changes that     lead to esophageal cancer. The investigators hypothesis is that systematic collection of data     on the natural history of GERD and BE patients and risk factors for development of BE in     patients with chronic GERD and progression of BE to dysplasia and adenocarcinoma will provide     useful information to develop a decision model for risk stratification and risk reduction     strategies in these patients.      As of March 17, 2011, 585 patients have consented at the Kansas City VA Medical Center.   "
208212|NCT00574340|"     Hypoglycemia (low blood glucose level) occurs frequently in intensively treated patients with     diabetes. Although hypoglycemia was thought to occur almost exclusively in T1DM, with the     advent of improved metabolic control in T2DM, the incidence of hypoglycemia is rising in     these patients. Therefore in this application, we will test the novel hypothesis that prior     hypoglycemia will result in (cardiovascular complications) during subsequent hypoglycemia.   "
208213|NCT00574353|"     When used with a different radioactive tracer called FMISO, a PET scan can find areas of low     oxygen in the tumor. We think that having areas of low oxygen is a reason why some tumors are     hard to treat with radiation.      In a past study, FMISO PET scans were performed in 6 patients with rectal cancer that could     not be operated on and that had spread to other areas. In this group of patients, FMISO PET     scans were able to find the low oxygen areas in their tumors. But this study included only a     few patients. In the present study, we want to use FMISO PET scans in patients who have     tumors that can be operated on. This group of patients will have radiation, chemotherapy or     both before they have their surgery. We want to see if FMISO PET can find low oxygen areas in     this distinct group of patients.   "
208214|NCT00574366|"     RATIONALE: Erlotinib and everolimus may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Giving erlotinib together with everolimus may kill more     tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving erlotinib     together with everolimus and to see how well it works in treating patients with metastatic     breast cancer.   "
208215|NCT00574379|"     Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either     once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in     the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline     in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.   "
208216|NCT00574392|"     The purpose of this study is to image skin and skin lesions with a new imaging technology     called multiwavelength and coherence confocal reflectance microscopy. This technology uses     low intensity laser to image below the surface of the skin. This technology may provide a new     way of looking at skin and skin lesions. The goal of this study is to evaluate the images of     your skin taken by this microscope.      The techniques being evaluated in this study use multi wavelength and coherence confocal     reflectance microscopy invivo. The term in vivo means in/on a living subject. In this study     you will be the living subject and the multi wave length and coherence confocal microscope     will be placed on your skin to look at your skin lesions and your normal skin. The confocal     microscope uses a weak laser light and a sophisticated lens to image the individual cells     that make up the skin. Your lesion will be photographed with high resolution photography. An     area near your skin lesion that is clinically normal will also be imaged in the same manner.   "
208241|NCT00574717|"     To determine if wearing a moderate spectacle under-correction (3.00D) and performing     activities designed to stimulate accurate accommodation during a 15-month period will enhance     emmetropization in highly hyperopic (between +5.00D and +7.00D) 3-month old infants.   "
208283|NCT00575276|"     This study looks at the differences in inflammatory mediators in gallbladder tissue between     males and females and the possibility that these differences contribute to a higher     perception of post-operative pain in females following laparoscopic cholecystectomy.   "
208254|NCT00574886|"     This trial was made available as a compassionate use protocol for patients who failed     induction chemotherapy + Vaccine on trials 197-99 and 196-99. These follicular NHL patients     then went on to high dose BEAM chemotherapy and transplant. Patients received idiotype     vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a     fifth series given 12 weeks after the fourth. Patients are then followed annually until     progression or death with standard staging. Immune response testing continues annually on     patients who continue to have a response post transplant.   "
208267|NCT00575068|"     The purpose of this study is to determine whether anti-CD80 monoclonal antibody (IDEC-114) is     effective in the treatment of follicular B-cell non-Hodgkin's lymphoma. This drug has never     been studied in patients with lymphoma, however, it has been studied in psoriasis patients at     various dose levels and schedules.   "
208405|NCT00579878|"     The study has been designed as a 48-week, double-blind, randomized, controlled study     comparing the use of leflunomide alone to combinations of leflunomide-sulfasalazine-HCQ, and     methotrexate-sulfasalazine-HCQ.   "
208217|NCT00574405|"     Type I diabetes (T1DM) is the second most common chronic illness effecting children in the     USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology     remains elusive. Nevertheless, recent data supports the notion that early and intensive     management of Type I diabetes can 1) decrease long-term complications of diabetes; and 2) may     significantly improve beta cell function and insulin secretion over ensuing years. To this     end, we propose using insulin pump therapy to preserve and/or enhance residual endogenous     B-cell secretory capacity among patients with newly diagnosed Type 1 DM. Furthermore, we     anticipate that early use of an insulin pump will improve glycemic control beyond that     achieved with standard multiple daily injection (MDI) therapy, and will be well-tolerated by     the patient. These data will provide important pilot information to explore the potential     role of intensive insulin pump therapy in the treatment of children newly diagnosed with Type     I diabetes. The specific aim of this study is to test the following hypothesis: Early use of     insulin pump therapy is effective in preserving or enhancing residual endogenous pancreatic     B-cell secretory capacity among patients with newly diagnosed T1DM: Moreover, early use of an     insulin pump will improve glycemic control beyond that achieved with standard multiple     injection therapy, and will be well-tolerated by the patient.   "
208218|NCT00574418|"     A preliminary study to determine the efficacy of using energy specific far infrared (FIR)     radiation for the treatment of uterine fibroids.   "
208219|NCT00574431|"     Nutritional treatment has become an essential component of the management of critically ill,     due to better knowledge about positive impact of nutritional support. Malnutrition among ICU     patients is associated with increased morbidity, mortality, length of stay (LOS) and     therefore higher costs.Several studies however suggest, that early implementation of     nutritional support is associated with improved clinical outcome, shorter LOS, and decreased     infection rates. One of the objectives of this study is to determine if an nutrition protocol     can improve the delivery of enteral tube feeding in the ICU.   "
208220|NCT00574444|"     We propose a phase I study of laparoscopic assisted, transvaginal peritoneoscopy by using     flexible endoscopy in female patients with pelvic pain. It is designed as a hybrid procedure     with laparoscopy using one port for adequate safety with the ultimate goal in the future that     transvaginal NOTES can replace therapeutic pelviscopy for this indication. The standard     number of port sites for diagnostic laparoscopy is 2-3. By reducing the number and size of     laparoscopic port, patients should already experience benefits from this hybrid procedure.   "
208221|NCT00574457|"     1) Research questions:      1a. Can non-sonographer health care professionals in a community medical office practice     setting be trained to detect and evaluate subclinical atherosclerosis?      1b. Can carotid ultrasound performed in community office practices improve physician use of     evidence-based, risk-reducing interventions and patient motivation to adhere to therapeutic     recommendations?   "
208222|NCT00574470|"     The purpose of this study is to see whether serious graft versus host disease which is not     well controlled with steroid treatment can be controlled with therapy with both daclizumab     and infliximab. We hypothesize that a combination of daclizumab and infliximab will more     effectively treat graft versus host disease than therapy with a single drug. The study also     looks at whether chronic graft versus host disease develops, and survival at 6 and 9 months     post-treatment.   "
208223|NCT00574483|"     The overall response to standard therapies and to the newer antiangiogenesis therapies is not     curative, and treatment-associated toxicities may be severe. Therefore, continued evaluation     of therapies, with different mechanisms of action, is needed for patients with metastatic     RCC.   "
208224|NCT00574496|"     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem     cells. When the healthy stem cells from a donor are infused into the patient they may help     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Sometimes the transplanted cells from a donor can make an immune response against the body's     normal cells. Giving cyclosporine, mycophenolate mofetil, and methotrexate before and after     transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well combination chemotherapy followed by donor     stem cell transplant works in treating patients with relapsed or high-risk primary refractory     Hodgkin lymphoma.   "
208225|NCT00574509|"     The purpose of this study is to assess the safety of 131I-anti-B1 Radioimmunotherapy when     combined with high-dose BEAM or BEAC chemotherapy and hematopoietic stem cell     transplantation. The study will also compare the difference in response rates and time to     treatment failure between historical control patients receiving high-dose BEAM or BEAC     chemotherapy with autologous hematopoietic stem cell transplant and patients receiving     radioimmunotherapy and high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem     cell transplant. Patients will receive escalating doses of radioimmunotherapy with anti-B1     radiolabeled with 131Iodine, high-dose carmustine, etoposide, cytarabine and Melphalan (BEAM)     chemotherapy, and autologous hematopoietic stem cell transplant.   "
208226|NCT00574522|"     The investigators are proposing that energy specific electromagnetic radiation of the central     nervous system, the viscera and the endocrine system has the potential to enhance the immune     system; thereby enhancing the production of killer cells to fight and destroy the human     immunodeficiency virus.   "
208236|NCT00574652|"     A systemic Vasculitis is found in 5 to 10% of HCV infected patients with mixed     cryoglobulinemia (MC). It mainly involves the skin, peripheral nerve and the kidney and may     be life threatening. Twenty to 30% of HCV-MC Vasculitis patients are resistant to     conventional therapy (i.e. antiviral therapy and/or immunosuppressors) and still have an     active disease. Thus, new therapeutic approaches are necessary in such patients. We recently     described a regulatory T cell (Treg) deficiency in HCV-related Vasculitis patients.     Immunomodulatory effects of interleukin-2 (IL-2) are well established, notably the     preferential expansion of Treg able to suppress inflammatory responses mediated by CD4+ and     CD8+ T cells.   "
208237|NCT00574665|"     The purpose of this study is to learn more about why patients with diabetes have increased     heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood     vessel. The proposed protocol will study the separate and combined effects of hyperglycemia     and hyperinsulinemia on endothelial function and fibrinolytic balance in Type 2 DM. Our     hypothesis is that hyperglycemia, rather than hyperinsulinemia, is responsible for the     dysregulation of fibrinolytic balance in diabetics.   "
208227|NCT00574535|"     Heart disease is not just the number one killer of women, it is also a leading cause of     disability. While it is generally believed that heart disease in women is a disease of old     age, the stark reality is that heart disease is responsible for more deaths than breast     cancer AT ALL AGES. Also, when young women develop heart disease, they are more likely to die     or become disabled than their male peers. Identifying women at risk for heart disease is an     important step toward reducing the impact of this disease.      Although women can develop heart disease at any age, most women show signs and symptoms of     disease about 10 years after men. For years, it has been thought that the reason for this lag     is that women's hearts are protected by estrogen, and that when women go through menopause     and lose their natural estrogen, they also lose their protection from heart disease. It has     been assumed that if estrogen is replaced then protection will continue. These assumptions     have not been proven. In fact, three large, randomized trials have shown no benefit from     hormone replacement therapy in women known to have heart disease, and in fact have shown that     hormone replacement may be harmful.      To better understand the role of hormones and heart disease, the investigators propose to     look at markers of heart disease in healthy women and compare this to their natural hormone     levels. One of the markers known to be related to heart disease is carotid artery     intima-medial thickness (c-IMT) which can be measured by creating an ultrasound picture of an     artery in the neck. The investgators will use c-IMT scans and serum blood samples from women     in the NIH-sponsored Los Angeles Atherosclerosis Study (LAAS), a large epidemiologic study     that followed participants for 8 years. The proposed study will use risk factor information,     serum samples and c-IMT scans collected from the female participants (about 269 women) over     the 8 years of follow-up. The total sample size is 269 subjects, each of whom donated 3 blood     specimens for the LAAS study. This research will examine those specimens (800 in total). It     will also measure other markers of heart disease, including inflammation (hsCRP) and diabetes     (insulin and glucose). All information has been obtained and there will be no need to collect     additional information from participants nor additional blood specimens.   "
208228|NCT00574548|"     The objective of this study is to compare the safety, tolerability and immunologic response     to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that     have never received a previous dose of 23vPS.   "
208229|NCT00574561|"     The investigators wish to study the magnetic field map using magnetocardiography (MCG) in     subjects undergoing computed tomographic angiography (visualization of the heart arteries     using CT scanning, CTA). The main purposes is to investigate if MCG is capable of detecting     the presence of obstructive coronary artery disease (CAD) as detected by CT angiography (CTA)     as well if the MCG can exclude the presence of CAD as defined by CTA.      Secondarily the investigators will look at the correlation of MCG with non-obstructive CAD     and the correlation of MCG with other tests (treadmill testing, stress echo or nuclear scan,     coronary angiography) done as part of the work up for CAD.   "
208230|NCT00574574|"     The purpose of this study is to determine whether short-term exposure to a compound found in     some fruits and vegetables (anthocyanin), is effective in improving skin health and reducing     the levels of various markers of cardiovascular disease risk. A range of skin health     parameters are being studied and volunteers are also providing skin biopsy, urine and blood     samples. 62 postmenopausal women have been recruited for this study.   "
208231|NCT00574587|"     Chemotherapy plus trastuzumab (Herceptin) are standard treatments for breast cancer. There     are circumstances where these treatments are given prior to surgery to reduce the size of the     cancer and imptove the surgical outcome. In this trial, an oral drug called vorinostat will     be given in combination with chemotherapy and trastuzumab. Vorinostat is a histone     deacetylase (HDAC) inhibitor which is approved by the U.S. Food and Drug Administration for     the treatment of a rare type of cancer involving the skin (cutaneous T cell lymphoma), but     not for breast cancer. HDAC inhibitors work by unsilencing tumor suppressor genes and other     genes in the cancer cells that are repressed; when the genes are turned back on by the drug,     it leads to death of the cancer cells. HDAC inhibitors such as vorinostat have been shown to     enhance the effects of chemotherapy and trastuzumab in experimental systems. The purpose of     this trial is to determine the optimal dose of vorinostat to use in combination with standard     chemotherapy plus trastuzumab, and to determine whether vorinostat enhances the effectiveness     of standard chemotherapy plus trastuzumab.   "
208232|NCT00574600|"     The purpose of this study is to evaluate the safety of and immune response to an experimental     DNA HIV vaccine followed by boosting with an experimental modified vaccinia HIV vaccine (MVA)     in HIV uninfected adults.   "
208233|NCT00574613|"     Transforming growth factor-beta 1 (TGF-β1) is consistently over expressed in most fibrotic     diseases and displays a variety of profibrotic effects in fibroblasts. Activation of TGF-β     receptors induces the activation of several kinase signalling cascades leading to the     phosphorylation of SMAD proteins as well as to the activation of SMAD-independent kinases     that collectively activate ECM synthesis and fibroblast growth and differentiation into     myofibroblasts. TGF-β1 is one of the main mediators in the fibrotic process, associated to     both scarring and a long list of pathologies related to chronic inflammation and which affect     all type of organs and tissues. An increase in TGF-β1 mRNA and protein levels has been     described in these processes. Peptide 144 (P144) is the acetic salt of a 14mer peptide from     human TGF-β1 type III receptor (betaglycan). P144 TGF-β1-inhibitor has been specifically     designed to block the interaction between TGF-β1 and TGF-β1 type III receptor, thus blocking     its biological effects. P144 has shown significant antifibrotic activity in mice receiving     repeated subcutaneous injections of bleomycin, a widely accepted animal model of human     scleroderma, and could contribute to the development. The purpose of this study is to asses     the efficacy and safety of topical application of P144 in the treatment of skin fibrosis in     patients with systemic sclerosis.   "
208234|NCT00574626|"     The purpose of this study is to evaluate the difference in relapse rates and long term event     free survival in patients with intermediate grade or immunoblastic non-Hodgkin's lymphoma     (NHL) whose marrow is not obviously involved with NHL who are randomized to receive either an     autologous bone marrow (ABMT) or peripheral stem cell transplant (PSCT). All patients with     intermediate grade NHL with histologic negative bone marrow who would otherwise meet all     eligibility criteria for high-dose therapy and ABMT are eligible for this study. Patients who     are eligible will be randomized to either PSCT or ABMT at the time of enrollment into our     transplant program.   "
208235|NCT00574639|"     The purpose of this study is to determine the way by which Alprazolam (Xanax) an anti-anxiety     drug affects specialized molecules in your brain called GABA (A) receptors that alter your     body's ability to defend itself from low blood sugar (hypoglycemia). We hypothesize that     prior activation of GABA (A) receptors may result in blunting of counterregulatory responses     during subsequent hypoglycemia and exercise.   "
208238|NCT00574678|"     This study will further evaluate the use of protein identification or protein pattern     (signature) found in tears. We hypothesize that differences exist between the protein profile     in tear fluid from patients with versus without cancer.   "
215811|NCT00676052|"     The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with     placebo in subjects with COPD.   "
208242|NCT00574730|"     This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with     rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent     non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression,     molecular response, and immunologic parameters related to this treatment.will have an ocular     exam prior to treatment.      Patients in this study will receive 6 cycles of combination chemotherapy with the standard     CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for     six to eight cycles. Patients achieving at least a partial response to chemotherapy will     begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be     continued for 12 months in the absence of signs of progressive/recurrent disease, or     unacceptable toxicity/intolerance of therapy. PEG Intron dosing will be adjusted based on the     presence of symptoms or other clinical manifestations of toxicity. Patients will undergo bone     marrow evaluation for molecular testing at baseline. Those found to be positive will have     repeat assessments performed post induction therapy, and after six months of PEG Intron.     Patients will also undergo immunologic evaluation at baseline, post induction therapy, and     after six months of PEG Intron. At the end of PEG Intron therapy, patients will have disease     reevaluation and then annual data collection for long-term toxicity, duration of response and     survival.   "
208243|NCT00574743|"     This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in     de novo heart recipients.   "
208244|NCT00574756|"     The purpose of this study is to evaluate the effects of ranolazine, an FDA-approved     medication for the treatment of angina, on heart function by using echocardiography.   "
208245|NCT00574769|"     Prostate cancer is a common and important health issue. Although effective treatment is often     available for localized disease, metastatic prostate cancer remains incurable. The initial     treatment for metastatic prostate cancer often includes medical or surgical treatments that     deprive the tumor of male hormones (androgens) required for growth. Although this treatment     is successful for many patients, the cancer may eventually return in others. Recurrent     prostate cancer may be treated with additional hormonal agents, but these agents usually do     not result in long-term control of the disease. Eventually most patients with recurrent     prostate cancer progress to a state where the cancer grows despite very low level of     circulating male hormones known as androgen independent prostate cancer (AIPC).   "
208246|NCT00574782|"     In an observational multi-centre study (CHALLENGE), the effects were assessed of starting     treatment with low doses of rosuvastatin in statin naive patients with a history of coronary     heart disease (CHD), peripheral vascular disease (PVD), cerebrovascular accident (CVA),     transient ischemic attack (TIA) or diabetes (DM), on low-density lipoprotein cholesterol     (LDL-C) goal achievement. Also proportional changes in LDL-C, high-density lipoprotein     cholesterol (HDL-C), total cholesterol (TC), triglycerides (TG) and the ratio TC/HDL-C were     studied.   "
208247|NCT00574795|"     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the     13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.   "
208248|NCT00574808|"     The aim of the proposed study is to implement and evaluate Outreach Facilitation as a means     to increase the uptake of evidence-based practice for secondary prevention and management of     patients with established CVD and cardiovascular risk factors, in primary care practices     throughout the Champlain LHIN. This initiative centers on the use of an Outreach Facilitation     Model, in which skilled health professionals known as facilitators (Practice Change     Consultants) serve as an expert resource to primary care practices in three areas: a)     practice performance assessment, feedback, and consensus building towards goal setting and     implementation; b) clinical, technical, organizational resources and practical advice; and c)     encouragement to face and move through the challenges associated with implementing system     change.   "
208249|NCT00574821|"     The purpose of this research study is to further establish the diagnostic use of     magnetocardiography (MCG) in patients with hypertrophic cardiomyopathy (HCM). The use of MCG     has not been extensively studied in these patients. This pilot study will serve to further     characterize abnormalities found on MCG in comparison to patients without hypertrophic     cardiomyopathy. Additionally, the study will be used to understand whether MCG has any     additional diagnostic utility in offering clinicians insight on the patient's disease state,     thereby aiding in the development of treatment plans.      This research study is designed to test the effectiveness of the investigational use of     magnetocardiography in patients with hypertrophic cardiomyopathy. The device itself has been     approved by the U.S Food and Drug Administration (FDA).   "
208250|NCT00574834|"     The study will be focused on determining the integrated in-vivo mechanisms responsible for     Ramipril's effects on delaying type 2 diabetes and restoring normal (blood sugar levels)     glycemia in patients with impaired glucose tolerance.      Hypothesis - Ramipril effects will delay the onset of type 2 diabetes and restore normal     glycemia in patients with impaired glucose tolerance.   "
208251|NCT00574847|"     Depression is commonly seen in patients with cardiovascular disorders. In recent studies it     has been shown that mild to moderate depression symptoms were associated with increased     likelihood of mental stress-induced myocardial ischemia (MSIMI), which is a risk factor of     poor cardiac outcome. In this project, the investigators aim to assess the treatment of     mental stress-induced myocardial ischemia in ischemic heart disease patients with mild to     moderate depressive symptoms. This study is a six-week double-blind placebo controlled study     to examine the effects of escitalopram on mental stress-induced myocardial ischemia. This     study will look to show that patients with ischemic heart disease who are treated with     escitalopram will exhibit a significant improvement of MSIMI at the end of week 6 compared to     patients receiving placebo.   "
208252|NCT00574860|"     Randomized, double-blind, placebo-controlled study for the treatment of head and neck     cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral     mucositis(OM).   "
208253|NCT00574873|"     Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of     bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase     Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one     year.   "
208265|NCT00575042|"     This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with     primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.   "
208255|NCT00574899|"     Radical Prostatectomy (removal of the prostate) or radiation therapy provide excellent     outcomes for patients with localized (confined to one area) disease, yet there is still no     effective treatment once the disease has spread beyond the prostate gland. Typically, a serum     PSA test is done to diagnose prostate cancer. Following diagnosis, a prostate biopsy and     other tests help to classify the patient's disease according to the likelihood of a     recurrence. However, these assessments are imperfect. There is a need to identify and     evaluate prostate biomarkers that will provide exact information regarding the likelihood of     a recurrence (prediction) of prostate cancer.   "
208256|NCT00574912|"     The study is to determine the dose response relationship of insulin glargine in type 2     diabetes over a 24-hour period and measuring the differences in glucose production among the     differing doses of glargine.      Hypothesis: Differing doses of insulin glargine over a 24-hour period in type 2 diabetes will     show differing effects on endogenous glucose production, glucose disposal and carbohydrate     and lipid flux.   "
208257|NCT00574925|"     The primary objective of this study is to investigate whether eradication treatment of     Helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the     time to relapse in patients with gastroesophageal reflux disease (GERD).      A relapse is defined by two consecutive symptom scores of the Eraflux questionnaire within 14     days that are equal or above the critical value of 25.      The secondary objectives are        1. To compare the time to relapse in the two H. pylori positive study groups with the H.          pylori negative control group        2. To compare the pattern of inflammation and atrophy in the two H. pylori positive          treatment groups with the naturally H. pylori negative control group at relapse.        3. All the above objectives analyzed for the efficacy subset that is the per-protocol          patients broken down by effective H. pylori-eradication.      Secondary endpoints will be analyzed by the following parameters and their interactions:        1. Treatment : Eradicated, Non-eradicated, Hp-negative control        2. Esophagitis at study start: grades 0, A/B and C/D        3. Gender        4. Alcohol intake        5. NSAID/ASA intake (for histological results)             -  Trial with medicinal product   "
208258|NCT00574951|"     RATIONALE: AMG 706 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well AMG 706 works in treating patients with     persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary     peritoneal cancer.   "
208259|NCT00574964|"     The purpose of this research study is to determine if combining all three treatments of     Gliadel wafers, Temozolomide and Radiation therapy at the same time is safe and more     effective than one treatment at a time. The study will measure the survival of subjects     treated with this combination of drugs.   "
208260|NCT00574977|"     The purpose of this study is to determine the safety and maximum tolerated dose from     injecting this vaccinia virus into tumors or infusion.   "
208261|NCT00574990|"     The purpose of this research study is to examine the clinical processes of care involved with     the sharing and communicating of medication management information in the inpatient setting     between nurses, pharmacists and physicians. The study is unique in that few studies have     examined communication content and processes in depth and in relation to specific clinical     care. The study will be conducted in two phases. The first phase involves using three focus     groups across three sites (a total of nine) each involving between 6-8 individuals to examine     perceptions regarding role and procedures associated with medication management. The focus     group discussions will be tape-recorded and analyzed using qualitative methods. The     information gleaned will assist us in identifying patterns of problems in enhancing the     sharing of information, to develop better measures for assessing communication as well as     designing effective interventions to enhance communication.      In the second phase of the study, 400 2-4 hour time slots will be randomly selected over     about a 5-week period for nursing staff and 500 events over a 6-week period for physicians to     conduct ethnographic observations during which specific communication events will be recorded     and coded. Every effort will be made to minimize interruptions during clinical care. This     research has not been done in terms of medication management content in the inpatient setting     (non-ICU).   "
208262|NCT00575003|"     The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or     cat allergy compared to placebo in adult patients.   "
208263|NCT00575016|"     The purpose of this study is to explore the effectiveness and safety of several doses of     botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.   "
208264|NCT00575029|"     Megestrol Acetate (MA) is a progesterone-like hormone that has been utilized as a birth     control agent, chemotherapeutic drug, and more recently, to induce appetite and weight gain     in patients malnourished as a result of radiation therapy, chemotherapy, cystic fibrosis,     AIDS, or dementia. The mechanism of MA-stimulated appetite and weight gain is unknown.      Although only approved to combat weight loss associated with AIDS and cancer, MA is     frequently prescribed for long periods of time to prevent or reverse weight loss in nursing     home residents and in elderly patients with serious illnesses in the community. Little data     is available to support this practice. Among its many properties, MA acts as a partial     glucocorticoid agonist, and long term and short term use of MA may results in adrenal     suppression. The rapidity of the onset of MA-induced adrenal suppression and the time course     of resumption of normal adrenal function after discontinuation of MA is completely unknown.     As a consequence, it is unclear whether MA can be given safely for short periods of time or     whether glucocorticoid administration is necessary after abruptly stopping MA treatment. The     increased use of MA in the frail elderly, where even partial adrenal insufficiency may pose a     substantial risk of adrenal crisis after an illness, requires a clear understanding of these     issues. To address these concerns, we will evaluate adrenal function before, during, and     after MA administration in healthy volunteers between the ages of 60 and 85 years.   "
208266|NCT00575055|"     This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple     dose study in male and female patients ages 50 to less than 89 years with mild to moderate     AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be     randomized to receive either bapineuzumab or placebo. Each patient's participation will last     approximately 1.5 years.      Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid     peptide, and is designed to provide antibodies to beta amyloid directly to the patient.   "
208268|NCT00575081|"     The NIH grant has funded the development of a physiological brain atlas registry that will     allow us to significantly improve the data collectioin and use of physiological data into a     normalized brain volume. This initially was used to improve DBS implants for Parkinson's     Disease, Dystonia, Essential Tremor, and OCD, but now includes data acquired during all     stereotactic brain procedures.   "
208269|NCT00575094|"     To purpose of this study is to assess the safety and tolerability of intravenous (IV)     tigecycline in hospitalized subjects of Japanese descent with community-acquired pneumonia     (CAP).   "
208270|NCT00575107|"     Evaluation of a new exercise machine designed to improve strength and speed of movement in     the leg muscles. Investigators are trying to learn whether a new training method results in     greater strength improvements as compared to a traditional method.   "
208271|NCT00575120|"     The purpose of this study is to assess the applicability of a new SSFP-based BOLD sensitive     MRI sequence in evaluating endothelial function. Endothelial function will be tested in a     setting of reactive hyperemia in the forearm. In a setting of ischemia-reperfusion, the     effect of transient endothelial function impairment will be tested. Comparison with     endothelial function assessment by brachial ultrasound (FMD) and finger tip plethysmography     (PAT) will be incorporated.      Hypothesis: BOLD-MRI is a feasible tool to assess endothelial function in the human forearm     during reactive hyperemia. There is significant correlation to established flow-mediated     dilation (FMD).   "
208272|NCT00575133|"     To assess the importance of intracellular signalling pathways and its deregulation in     adiposity and diabetes-related insulin resistance, liver tissue samples of patients suffering     from non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)will     be analyzed prospectively from a liver tissue bank.   "
208273|NCT00575146|"     To determine whether a mild ketogenic diet can influences quality of life and survival of     patients with recurrent glioblastoma   "
208274|NCT00575159|"     The purpose of this research study is to look at concentrations of GSK189075 in blood when     single doses of the drug are taken by mouth in combination with basal insulin. The clinical     effects of the drug in combination with insulin on the body will also be studied. The results     will help determine doses of GSK189075 can be studied in the future in the type I diabetes     mellitus population.   "
208275|NCT00575172|"     For the purpose of comparing efficacy of intensive therapy between 1) ultrarapid-acting type     insulin (insulin aspart) and 2) conventional rapid-acting type insulin (R), a Multicenter     Open Label Randomized Controlled Trial was planned in Japan using the occurrence of     cardiovascular events in patients with diabetes, a high risk factor, as an index.   "
208276|NCT00575185|"     This will be a randomized, placebo-controlled, double-blind single-center proof of concept     study to evaluate the anti-EBV activity of 4 grams of valomaciclovir (2 grams BID) for 21     days in subjects with infectious mononucleosis documented to be caused by primary EBV     infection. Otherwise healthy subjects (≥15 years old) referred to us with a clinical     diagnosis of primary infectious mononucleosis will be screened and those with     laboratory-confirmed primary EBV infection will be enrolled.   "
208277|NCT00575198|"     The purpose of this study is to determine whether chest tubes can be safely removed without     considering how much fluid is draining through the tube.   "
208278|NCT00575211|"     This is a multi-center, prospective evaluation of left ventricular recovery on conventional     therapy in patients with the recent onset of dilated cardiomyopathy. In some subjects with     this disorder, the heart will recover significantly over the first year, while others will be     left with a chronically weak heart. The proteins that help the heart recover are encoded by     genes, which can differ markedly between individuals. The goal of the current study is to     determine whether variation in these genes involved affect the probability that the heart     will recover. We will also look at which genes are involved in inflammation and which ones     are turned on (producing proteins) in circulating white blood cells.{These statements will     only be added if the site has chosen to participate in RNA analysis}. In addition, this study     will look at how levels of proteins in the blood, proteins called cytokines' which control     inflammation and proteins called neurohormones which are released when the heart weakens,     affect the likelihood of recovery.      Enrollment will take place at 15 centers. The goal is to enroll approximately 500 adult     subjects (age 18 years or older, both men and women) over the course of approximately 48     months.   "
208279|NCT00575224|"     The purpose of this research study is to test the safety, tolerability, and effectiveness of     the drugs Pegasys and Copegus when used for hepatitis C genotypes 6, 7, 8, and 9. Patients     are randomly assigned (by chance) to either Treatment Group A (Pegasys and Copegus for 24     weeks) or Treatment Group B (Pegasys and Copegus for 48 weeks).   "
208280|NCT00575237|"     A pulmonary recruitment maneuver at the end of surgery reduced shoulder pain as well as     nausea and vomiting after laparoscopic surgery.   "
208281|NCT00575250|"     We wish to investigate whether a weekly, 2½ hour group-based osteoporosis education     intervention (the Osteoporosis Prevention and Self-Management Course), is different to one     session course (1x 2½ hours) on osteoporosis knowledge, confidence to eat calcium-containing     foods, confidence to exercise, and amount of exercise undertaken after three and nine months     of follow-up in people aged over 50 years who have already had a bone fracture.   "
208282|NCT00575263|"     The human tooth pulp has many nerve fibers and is a common source of pain. This study     examines nerve fibers within normal and painful samples and identifies changes that can     contribute to the generation of pain.   "
208284|NCT00575302|"     In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old     are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment     will be analyzed.   "
208313|NCT00568893|"     This trial is to obtain safety data in adult patients with severe sepsis and two     sepsis-induced organ infections who receive an infusion of drotrecogin alfa (activated).   "
208314|NCT00568906|"     This study will investigate gene expression profiles in normal human lung tissue, lung     carcinoma and metastatic tumor to the lung. The expression of up to 20,000 genes in a given     lung tissue sample will be examined by cDNA microarray analysis and compared to normal lung     tissue. In addition, we hope to identify a particular subset of lung cancer cells with an     enhanced capacity for proliferation and self-renewal , analogous to the stem cells recently     identified for certain types of leukemia, breast cancer and brain tumors.   "
208285|NCT00575315|"     Effective therapy for human immunodeficiency virus (HIV) infection has markedly prolonged     survival in infected individuals. As a result, other diseases are now becoming clinically     significant. Approximately 30% of HIV infected patients are co-infected with hepatitis C     virus (HCV) which is now the leading co-morbid disease in co-infected individuals. The     histologic severity and natural history of HCV has been reported to be accelerated in those     co-infected with HIV. It is hypothesized that 1) the severity and progression of HCV disease     is related to the immune competence of the individual, 2) immune restoration associated with     HIV therapy may further accelerate the progression of HCV disease which may explain the     marked increase in HCV related morbidity and mortality observed in recent years, and 3) the     virologic response to anti-HCV treatment is directly related to the degree of immunologic     competence. The specific aims of the proposal are: 1) To obtain, through multi-disciplinary     didactic teaching, the necessary skills of clinical research design, data collection, data     analysis, and biostatistical methods and 2) To study the impact of HIV disease on HCV, the     effect of the immune function and immune restoration during HIV therapy on the natural     history of HCV, and the efficacy of HCV treatment in HIV co-infection.   "
208286|NCT00575328|"     The purpose of this research study is to find out whether Maca Root is effective for treating     sexual dysfunction in females that is caused by the treatment for bipolar disorder. An     additional aim of the study is to document the safety and tolerability of maca root, as well     as any potential side effects that it causes. We suspect that Maca Root will result in a     significant reduction in sexual dysfunction when compared to a placebo group.   "
208287|NCT00575341|"     30 adolescent girls and young women between 13 and 26 years with central adrenal     insufficiency and a grand shortage of DHEA are recruit. The clinical trial is double-blind to     show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances     well being and mood of the patients. It should also normalize the serum content of DHEA,     aldosterone and testosterone.   "
208288|NCT00575354|"     Generally, benign breast tumors are excised under the local anesthesia. But such action was     so invasive that every patient would experience the physiological and psychological stimuli     unavoidably. Sevoflurane was advised as a better inhalational anesthesic for its easy     come,easy go property during short-lasting operations than isoflurane. We purposed that     sevoflurane would be a superior anesthesic for benign breast tumor excision than isoflurane     with relative less alteration in hemodynamics, less postoperative side effects and     easily-control the depth of anesthesia.   "
208289|NCT00575367|"     The purpose of this study is to evaluate the drug concentrations of AzaSite compared to     Vigamox in tears of healthy volunteers   "
208290|NCT00575380|"     The purpose of this study is to evaluate the drug concentrations in the conjunctiva and     aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract     surgery   "
208291|NCT00575393|"     RATIONALE: Gold sodium thiomalate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of gold sodium     thiomalate in treating patients with advanced non-small cell lung cancer.   "
208292|NCT00575406|"     Diffuse large B-cell lymphoma is the most prevalent subgroup within malignant lymphoma.     Clinical benefit has been shown for the treatment with cyclophosphamide, doxorubicin,     vincristin and prednisolone (CHOP regimen); this could be further improved recently by the     addition of rituximab (R-CHOP), a monoclonal antibody.      Improved response and overall survival rates make it necessary to evaluate late toxicities of     the therapy regimens. Cardiotoxicity is a known risk factor of specific chemotherapies, with     7% patients being affected if doxorubicin cumulative doses are under 550mg/sqm. Retrospective     data analyses indicate that this incidence of cardiotoxicity may be higher under combination     chemotherapy. Liposomal doxorubicin has been shown to have lower cardiotoxic effects and at     the same time equivalent or higher efficacy compared to conventional doxorubicin.      The aim of this study is to evaluate alternative regimens for the treatment of diffuse large     B-cell lymphoma, substituting liposomal doxorubicin (R-COMP) for conventional doxorubicin     (R-CHOP).   "
208293|NCT00575419|"     This will be a randomized prospective dose escalation clinical study of N-acetylcysteine     (NAC) in patients with stage 3 or worse renal failure (Glomerular Filtration Rate 30-60     ml/min calculated with the Modification of Diet in Renal Disease formula), undergoing a     procedure or imaging that requires the administration of contrast media at Oregon Health &     Science University or the Portland Veterans Hospital. Subjects will receive NAC 60 minutes     prior to the procedure or imaging requiring contrast media. Toxicity will be graded according     to NCI Common Toxicity Criteria (CTC) version 3.0. An adult Phase 1 dose escalation study of     NAC administered intravenously (IV) and intra-arterially (IA) will be performed. An isotonic     nonionic contrast agent will be used in all cases. Contrast Induced Nephropathy (CIN) is     defined as an increase in serum creatinine concentration of 25% or more from the subjects     baseline value within a 72-hour period after the administration of contrast media. Serum     creatinine concentration will be measured at admission, every day during in-patient     hospitalization, and at hospital discharge.   "
208294|NCT00575432|"     Multimodal functional magnetic resonance (MR) methods, including MR diffusion,     Blood-Oxygenation Level Dependent (BOLD) imaging and MR spectroscopy may provide     complementary information about the functional status of a kidney. The researchers     hypothesize that these non-invasive methods correlate with histology as gold standard and     compete favorably with conventional in part invasive evaluation methods, and thus provide     specific and early detection of kidney diseases of various etiologies, drug toxicity, or     renal allograft dysfunction.   "
208295|NCT00575445|"     The purpose of this study is to determine if exhaled nitric oxide (eNO) levels will be     increased in pediatric patients with uncontrolled asthma as determined by the Asthma Control     Test (ACT). During the study the investigators will also examine if the combination of eNO     and ACT will better predict asthma control that either tool alone when compared to a medical     provider's assessment of the patient's asthma control.   "
208296|NCT00575458|"     This study is comparing two different kinds of splints for patients who have had a surgical     contracture release of dupuytren's disease. It compares a static splint and a dynamic splint.   "
208315|NCT00568945|"     This trial has the primary goal to show that BAY68-4986 can lower the ventricular rate in     patients with the indication persistent atrial fibrillation.   "
208298|NCT00575484|"     At present the standard management of fluid overload in patients with congestive heart     failure (CHF) involves limiting the intake of salt and water while administering high dose     diuretics, often at the cost of deteriorating kidney function. However, another group of     researchers has previously shown that intravenously infusing small volumes of concentrated     saline during diuretic dosing and liberalizing dietary salt intake while continuing to limit     water consumption resulted in improved fluid removal in CHF patients. Furthermore, less     deterioration in kidney function, shorter hospitalizations, reduced readmission rates, and     even reduced mortality were observed. The present study will examine this novel therapy in a     population of 60 patients with underlying severe CHF and kidney dysfunction hospitalized for     the management of fluid overload. Half of these patients will receive investigational     treatment with concentrated salt infusions and liberalized salt consumption during diuretic     therapy. All patients will otherwise receive the standard therapies for heart failure,     including restrictions on water consumption. This study will attempt to verify the     improvements in clinical endpoints previously described and define the mechanisms of enhanced     fluid removal.   "
208299|NCT00575497|"     The study compares the benefits of short daily hemodialysis six days a week, nocturnal (night     time) hemodialysis six days a week, every other day and every other night hemodialysis to     traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis     treatment time and/or frequency will improve outcomes.   "
208300|NCT00575510|"     This project will examine whether a theory-based telephone intervention delivered by a nurse     at the time women are informed of an abnormal Pap test result will increase adherence to     follow-up recommendations.   "
208301|NCT00575523|"     Ultrasound guided percutaneous ethanol injection (PEI) is an established method in the     treatment of hepatocellular carcinoma (HCC) and considered a safe procedure with severe     complications occurring rarely. Previous studies revealed, that the occurrence of bradycardia     and sinuatrial blockage is quite frequent during ethanol instillation sometimes accompanied     by clinical complications such as unconsciousness, respiratory arrest or seizure like     symptoms. Study purpose is to evaluate whether the use of i.v. Atropine before starting     ethanol instillation can prevent dysrhythmias during instillation. Study design: randomized,     placebo controlled, double blinded study. Atropine or saline solution will be administered     intravenously to 40 patients immediately before starting percutaneous ethanol instillation. A     6 line ECG with limb leads will be recorded at rest and during ethanol instillation to reveal     possibly occurring dysrhythmias.   "
208302|NCT00575536|"     The purpose of this study is to determine the safe and effective levels of optical     stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery.   "
208303|NCT00575549|"     The purpose of this study is to prospectively analyze and compare conventional stress     echocardiograms and real-time myocardial contrast stress echocardiograms; and to determine     the effect of contrast agents used during real-time myocardial contrast stress     echocardiograms on serum troponin I levels.   "
208304|NCT00575562|"     The primary objective of this study is to assess the safety and tolerability of KRN330 in     patients with relapsed or refractory advanced or metastatic colorectal cancer.   "
208305|NCT00575575|"     The purposes of this research are:        -  to understand the status of suicidal ideation, suicidal behavior, and depression in          Harbin University students; and        -  to analyse the infect factors of suicidal ideation and suicidal behavior.      With cognitive behavior interventions on students with suicidal ideation, suicidal behavior,     and middle or high degree of depression, the researchers can provide a scientific and     effective intervention to the students.      Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial.      Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Department of Psychiatry,     University of Pennsylvania, Philadelphia 19104, USA. gregbrow@mail.med.upenn.edu JAMA. 2005     Aug 3;294(5):563-70.   "
208306|NCT00575588|"     Saxagliptin is a new investigational medication being developed for treatment of type 2     diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in     addition to metformin and compare to sulphonylurea in addition with metformin.   "
208307|NCT00575601|"     The purpose of this study is to determine whether simvastatin is effective in the improvement     of IVF-ICSI outcome in Pcos patients.   "
208308|NCT00575614|"     The purpose of this study is to determine whether prucalopride is safe and effective in the     treatment of chronic idiopathic constipation.      Hypothesis:      Prucalopride given at a dose of 1 mg o.d. for 4 weeks to female patients with chronic     constipation shows a favourable effect on most of the efficacy parameters assessed in this     trial. This dosage can be considered safe and generally well-tolerated.   "
208309|NCT00575627|"     Patients with chronic hepatitis C with persistently normal alanine aminotransferase (ALT)     levels have been generally excluded from treatment, because the strong conviction that normal     ALT would be synonymous of absence of liver damage. However, recent studies have demonstrated     marked liver fibrosis, including cirrhosis, in patients with HCV and persistently normal ALT     levels. Up to now, just a sigle randomized, controlled, multicenter study was lead to     evaluate the efficacy and safety of combined therapy in patients with chronic hepatitis C and     persistently normal serum ALT levels. Aim of our study is evaluate the efficacy of treatment     and the outcome of treated patients compared with a control group of untreated patients.   "
208310|NCT00575640|"     Clinically feasible dose of Hydralazine for ~ 3 months, by virtue of its demethylating     effect, will:        1. Result in re-expression of epigenetically silenced TSGs in rectal cancer specimens.        2. Decrease the global methylation in primary cancer cells compared to pre-treatment   "
208311|NCT00568867|"     The purpose of this study is to evaluate markers of immune response in human tumor samples.   "
208312|NCT00568880|"     RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Giving hydroxychloroquine together with bortezomib may kill more     cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of     hydroxychloroquine when given together with bortezomib and to see how well it works in     treating patients with relapsed or refractory multiple myeloma.   "
208316|NCT00575653|"     We are conducting a large, record-based study to assess the risk of Guillain-Barré Syndrome     (GBS), a serious demyelinating disease, following immunization with the tetravalent     meningococcal conjugate vaccine (Menactra) that is currently recommended for all adolescents.     The study was requested by CDC and FDA because of an unexpected number of case reports to the     CDC's Vaccine Adverse Event Reporting System (VAERS).      The study protocol was designed by the investigators, with input from FDA, CDC, and the     vaccine's manufacturer, Sanofi-Pasteur. An external advisory board that includes CDC     representation, provides input regarding important decisions. The manufacturer is not     participating in the conduct of the study and has no control over the analysis or     dissemination of results.      The study is derived from five large US health plans with a total membership of approximately     50 million over the study time period. America's Health Insurance Plans (AHIP) serves as     liaison between the health plans and the Coordinating Center at the Department of Ambulatory     Care and Prevention of Harvard Medical School and Harvard Pilgrim Health Care, and is the     contracting organization with the health plans.   "
208317|NCT00575666|"     This study is an 8-week, randomized, double-blind, placebo-controlled trial of intranasal     insulin as an adjunctive therapy, with a 4-week follow-up, in 60 non-diabetic schizophrenia     subjects to examine insulin's effect on psychopathology and cognition. In addition, the study     will examine insulin's effects on weight, food intake, resting energy expenditure, and body     composition.   "
208318|NCT00575679|"     The purpose of this study is to determine whether brief motivational interviews reduce the     likelihood of driving under the influence of alcohol (DUI).   "
208319|NCT00575692|"     The aim of the present study is to identify changes in the cardiovascular system in patients     with pulmonary hypertension (PH) by magnetic resonance imaging (MRI). MRI is accepted as     golden standard method for the evaluation of left and right ventricular morphology and     function.      All patients who showed elevated pulmonary pressure in the right heart catheter investigation     are assigned to MRI. Parameters derived from MRI are included in the clinical and therapeutic     decisions. Well established as well as new MRI parameters are evaluated and compared to the     results of right heart catheter. Further age-matched controls without known cardiac or     pulmonary disease are investigated by native MRI.   "
208320|NCT00575705|"     The University of Alabama at Birmingham Recessive Polycystic Kidney Disease Core Center (UAB     RPKDCC) has established a NIDDK-funded, interdisciplinary center of excellence in PKD-related     research, with specific emphasis on recessive PKD. Among the five Cores, the UAB RPKDCC     includes the ARPKD Clinical and Genetic Resource, a Core resource designed to develop a     unique set of clinical, genetic, and educational resources for ARPKD. The Core has three     primary objectives:        1. To extend the observational study of ARPKD initiated by the North American ARPKD          Database.        2. To provide a mechanism for genetic evaluation of patients with both classic ARPKD and          unusual phenotypes of recessive PKD.        3. To develop educational tools for physicians and patients regarding the natural history,          cause, development and effects of the disease, genetic testing, and clinical trials          applicable to ARPKD.   "
208321|NCT00575718|"     The purpose of this study is to see if we can find ways to improve the treatment of tobacco     dependence in patients who have cancer or may have cancer. We will compare two ways to help     people quit tobacco use before surgery and to stay quit after surgery. One way is a scheduled     reduced smoking program followed by use of the nicotine patch. In this program, the tobacco     user will gradually cut down on their tobacco use until they quit. Once they quit, they will     be offered the nicotine patch. We will compare this approach to our current program of     counseling and use of nicotine patch. What we learn from this study may help us to develop     new ways to help tobacco users and improve our current smoking cessation program.   "
208322|NCT00575731|"     Although studies demonstrate that people who consistently keep detailed food records are more     likely to maintain their weight, few people continue to keep records given the vigilant     attention needed. This study will test the efficacy of an alternative approach to record     keeping that may be easier for people to sustain and lead to better long-term weight     management. We propose that obese adults who attempt to keep their weight within a clearly     defined and personalized 'range', e.g., a 5-lb range between 200-205 pounds, will be more     likely to continue weighing themselves and remain weight stable because they have learned to     self-regulate, i.e., accurately monitor changes in their weight, alert themselves when     they've gained too much weight, and 'finetune' their eating and physical activity in     response, but with the minimum effort and attention necessary. The primary aim for this     randomized trial will examine whether participants in an 8-week 'Fine-Tuning' program are     more likely to weigh themselves over the 6-month study than participants in an 8-week     traditional 'Record-Keeping' program.   "
208323|NCT00575744|"     We continue to collect information in support of the hypothesis that the histology of the     first draining lymph node (sentinel node) accurately predicts the histology of the rest of     the axillary lymph nodes.   "
208324|NCT00575757|"     Because NASH is now recognized as a significant cause of cirrhosis with associated morbidity     and mortality, its recognition as a long term complication of HAART is important to the     management of those living with HIV.   "
208325|NCT00575783|"     The research study is designed to examine the impact of low blood sugar on brain function in     individuals with Type 1 Diabetes who have frequent and severe hypoglycemia (low blood sugar)     compared to those who do not.   "
208565|NCT00572338|"     The purpose of this study is to learn how myeloma cells grow and become a cancer, how to     distinguish them from normal cells and how to eliminate these cells selectively.   "
208326|NCT00575796|"     The overall objective of this study is to determine the efficacy of weekly Vinblastine in     chemotherapy naïve patients with progressive or incompletely resected paediatric low grade     glioma, to generate estimates of the response rate, progression-free survival, toxicity and     quality of daily living among the population treated and determine biologic factors which     will enable us to predict tumour behaviour.   "
208327|NCT00575809|"     Our study intends to evaluate prospectively the incidence and severity of oral mucositis in     patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as     well as to evaluate the potential influence of nutritional-, physical-, and     transplant-related factors associated with the development of this complication and its grade     of involvement.   "
208328|NCT00575822|"     The aim of this study was to determine the effectiveness of endoscopic full-thickness     plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in     comparison to a sham procedure.      Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were     entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight     patients were randomly assigned to undergo endoscopic full-thickness restructuring of the     gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group     assignments were revealed following the 3-month evaluation. The primary endpoint was ≥ 50%     improvement in GERD-HRQL score. Secondary endpoints included medication use and esophageal     acid exposure.      Patients achieving ≥ 50% improvement in GERD-HRQL score at 3-months versus baseline off-meds     were considered responsive to their assigned procedure. Patients who failed to reach this     level of improvement at 3-months were considered non-responders. Analysis of these     dichotomized variables (responder/non-responder) was done using Fisher's exact test comparing     the proportion of responders between the active and sham groups. Intent-to-treat analysis was     also performed. The null hypothesis was that the proportion of responders was the same in     both the active and sham groups. Testing was done at the 5% level of significance     (alpha=0.05).   "
208329|NCT00575835|"     The aim of this study is to compare oral vitamin D supplementation administered in two     different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year     (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily     supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH     vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of     25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in     vitamin D concentrations in these treatments. 3) Find out safety of these treatments   "
208330|NCT00575848|"     The goal of this project is to understand whether glycine is helpful for improving some     symptoms of schizophrenia such as low motivation, loss of interest, and social isolation. In     addition, the investigators want to find out if glycine improves memory.      This project involves a three-and-a-half month trial of glycine or placebo. A placebo looks     exactly like the study drug, but it contains no active drug. Glycine is a naturally occurring     substance that is a part of some of the proteins in your body. Glycine has not been approved     by the FDA (Food and Drug Administration) for the treatment of schizophrenia. However, the     FDA allows it to be used in research studies.      Related Study at McLean Hospital: If you would like to participate in this study of glycine     versus placebo at the Freedom Trail Clinic, the investigators will ask you if you would also     like to participate in a related study at McLean Hospital. The study at McLean Hospital will     look at the effects of glycine and placebo on levels of glycine in the brain. The study will     use magnetic resonance spectroscopy to measure brain glycine levels. The magnetic resonance     (MR) scanner looks like a large cylinder with a tube running down the center. You will be     asked to lie down on your back on a foam-padded table and place your head into a special     holder. The table will slide you inside the hole of the scanner. Soft foam rubber sponges     may be placed on both sides of your head for comfort and to help keep your head from moving.     Because the scanner contains a strong magnet, you will be asked to remove all metal objects     from your person including, but not limited to: watches, rings, necklaces, bracelets,     earrings and other body piercings, belts, loose change, wallet (with credit cards), items of     clothing containing magnetic materials (for example, underwire bras, certain types of     zippers), and shoes. These items will be secured in a safe place until your scan is     completed. You will be able to remain in your street clothes. The investigators will ask you     if study staff from McLean Hospital can contact you to tell you more about the study. You may     refuse to be contacted by McLean Hospital. However, if you do not participate in the study at     McLean, you are not eligible for the study here at the Freedom Trail Clinic.   "
208331|NCT00575861|"     Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair     250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased     total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven     pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor     by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.   "
208332|NCT00575874|"     The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to     pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of     treatment in patients with type 2 diabetes.   "
208333|NCT00575887|"     The purpose of this study is to evaluate the efficacy of temozolomide on a protracted     schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive     high grade glioma.   "
208334|NCT00575900|"     A three arms open,randomized interventional study in order to compare the impact of low     carbohydrate diets with different protein and fat ratios versus a standard balanced diet on     BMI and metabolic parameters in obese adolescents.      55 obese adolescents (12-18y, BMI > 95th percentile) were randomly allocated to one of three     12-weeks diet regimens: low-carbohydrate low-fat, low-carbohydrate high-fat or balanced     low-fat diet, followed by 9-months follow-up. Weight, Height, waist circumference, lipid     profile, glucose, insulin, liver enzymes, renal functions, C-reactive protein, leptin,     ghrelin and resting energy expenditure were measured in the morning after over-night fast at     baseline, during the 12-weeks of intervention and after 9-months of follow-up.   "
208335|NCT00575913|"     To assess, under daily practice conditions, the safety profile and the efficacy of a new     formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary     tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).   "
208361|NCT00579293|"     This study will compare two ways of having people respond to a questionnaire about health and     emotional well-being: on a computer and with paper and pencil. We will see how long it takes     using both methods. We will also ask you how you feel about using a computer to answer the     questions.   "
208362|NCT00579306|"     The goals of this trial are to determine the prognostic significance of an elevated level of     inflammatory blood markers in people who have experienced small subcortical strokes and who     are enrolled in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial.   "
208402|NCT00579839|"     To determine the short and long term effects of placental transfusion at birth by milking and     delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34     weeks 0 days weeks' gestation.   "
208363|NCT00579319|"     When breast MRI is used to determine the extent of local disease, the management changes,     resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is     better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of     disease in women diagnosed with breast cancer. It has not been established how management of     breast cancer patients has been affected by the use of breast MRI or how that management has     affected the outcome for these patients. This retrospective chart review will document     management and outcome for breast cancer patients who have had pre treatment breast MRI.   "
208364|NCT00579332|"     Pilot and feasibility diet and phyto-agent intervention among healthy men at risk for     prostate cancer progression.   "
208336|NCT00575926|"     Ganoderma lucidum (Lingzhi) is a Traditional Chinese Medicine which is widely used as a means     to 'strengthen immunity' among patients with cancers. However, there is no published     randomized controlled clinical trial on its efficacy and safety despite the many in vitro     studies on its anti-viral, anti-oxidative, anti-tumour, radioprotective, hepato-protective     and immunomodulatory effects. This study was a randomized, double-blind, placebo-controlled,     parallel clinical trial that investigated the benefits and safety of Ganoderma lucidum     (Lingzhi) in treating children with cancers. Patients were randomized to receive identical     capsules of either Lingzhi or placebo for six months. The primary outcome was the general     Paediatric Quality of Life score. Secondary outcomes included immune functions,     infection-related morbidities, complete blood counts and serum biochemistry, and overall and     event-free survival.   "
208337|NCT00575939|"     It is well known that HIV-infected subjects frequently experience hyperlipidemias, insulin     resistance, and visceral adiposity, which are known to increase the risk of atherosclerosis.     Several cohorts have shown an increased risk of heart disease in people with HIV. The effect     of HIV treatment versus HIV itself on the incidence of heart disease is unclear. In this     study the investigators will assess the effect on carotid IMT of the initiation of     antiretroviral combinations that are known to have a minimal effect on lipids and insulin     resistance. We will also assess the changes in several inflammation and cardiovascular     markers,as well as endothelial activation markers,and how these changes relate to     therapy-induced changes in immunologic, virologic and metabolic markers.   "
208338|NCT00575952|"     This phase I trial studies the side effects and best dose of intraperitoneal paclitaxel when     given together with doxorubicin hydrochloride and cisplatin in treating patients with stage     III-IV endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, doxorubicin     hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) and giving them in different ways may kill more tumor cells.   "
208339|NCT00575965|"     This research study seeks to find new ways to treat people with Waldenstrom's     Macroglobulinemia (WM). The study is for participants with slow growing WM who otherwise     might not need therapy for at least 3-6 months. Simvastatin is a drug approved by the FDA for     lowering cholesterol. In test tube studies the study drug appears to have direct anti-cancer     effect against WM tumor cells and mast cells.   "
208340|NCT00575978|"     This study will be conducted as a phase I/II clinical trial. In addition to determining the     maximum tolerated dose (MTD) of hydralazine, the phase I trial will be performed to identify     unexpected toxicities that may occur when hydralazine is used in conjunction with neoadjuvant     chemotherapy in normotensive women with breast cancer. Once the phase I trial is successfully     completed, the phase II trial to evaluate the efficacy of hydralazine in producing a     demethylation effect will begin.   "
208341|NCT00575991|"     The prevalence of overweight children has increased dramatically over the last decade, and     many overweight children will remain overweight as adults. Conjugated linoleic acid (CLA), a     naturally occurring dietary fatty acid, has shown promising results in reducing body fat     among adults, and we propose to test the efficacy of CLA supplementation on body fat     accretion in 6 to 10 year old children who are overweight or at risk of overweight.   "
208342|NCT00579033|"     Patients with focal dystonia experience uncontrollable movements of the hand during certain     types of skilled movements. Though the origin of the disorder is not fully understood, it is     thought that brain areas involved in moving the hands and receiving touch information from     the hands, are involved. For example, patients with dystonia affecting the hand show changes     in their ability to perceive touch - this is something that typically escapes the patients     own awareness. Further, the area of the brain receiving touch information has a disrupted     representation of the finger skin surfaces.      The goal of our research is to improve dystonia symptoms in patients with hand dystonia. We     will attempt to achieve this goal by implementing an intensive training treatment that     requires patients to attend to, and use touch information applied to specific fingertips.     Previous work has attempted to alter touch perception using sensory training and improvements     in motor control (hand writing) of dystonia patients were observed. For example, learning to     read Braille improves tactile perception and handwriting in focal hand dystonia. A different     approach to treat focal hand dystonia involves a technique called repetitive transcranial     magnetic stimulation (rTMS), and this can also temporarily improve hand writing in dystonia     patients. The proposed research will attempt to alter touch processing using touch training     alone, or in combination with rTMS. Rather than train using Braille reading, the sensory     training will be applied using a systematic, experimenter controlled stimulus set that     focuses on touch stimuli applied to individual digits. Importantly patients will have to     associate certain types of touch information with rewards and other touch input with the lack     of a reward.      The study will first involve measuring the location and representation of the touch in the     brain using multiple brain mapping tools. These tools include functional magnetic resonance     imaging and magnetoencephalography; when both tools are used a very accurate picture of     finger representation can be obtained, and we also know what brain areas respond to touch     stimuli. Dystonia symptoms and touch perception will also be assessed. Next, patients will     participate in a training intervention that involves 15 days(2.5 hr/day) of touch training     applied to the fingertips of the dystonia affected hand. Patients will identify the touch     targets amongst distractors and receive on-line performance feedback. The goal of the     training is to provide the cortex with regular boundaries of fingers and in this way, attempt     to re-shape the sensory cortex to accept these boundaries. Another group of patients will     receive rTMS. The goal of the rTMS is to create an environment in sensory cortex that is open     or 'ready' to accept changes induced by tactile stimulation. The rTMS will be immediately     followed by the tactile training. A third group of patients will receive a placebo version of     rTMS followed by tactile training. The latter group will allow us to understand if rTMS has a     definite effect on the physiology of the patient. Following the 15-day training, we will     assess the brains representation of fingertips, changes in dystonia symptoms and changes in     the perception of touch stimuli.      This research will advance the treatment of focal hand dystonia and assist the design of     precise remediation training tailored to the dystonia patient.   "
208343|NCT00579046|"     The purpose of this study is to determine the impact of erythropoietin treatment of anemia on     exercise capacity of patients with chronic obstructive pulmonary disease (COPD).   "
208344|NCT00579059|"     The purpose of this prospective clinical data collection is to compare the outcomes of two     different tibial bearings: the Maxim® Pop-Top® Tibia and Maxim® Modular Tibia.   "
208345|NCT00579072|"     The purpose of this study is to find out if therapy with hormones (such as Lupron, Casodex,     Zolodex or Degarelix) change a person's thinking abilities.   "
208346|NCT00579085|"     Complex Regional Pain Syndrome is a debilitating and extremely difficult to treat condition.     There is a large body of evidence demonstrating the therapeutic value of N-methyl-D-aspartate     (NMDA)-receptor antagonists in CRPS. The NMDA antagonist ketamine has been shown to be     effective in the treatment of CRPS, resulting in complete remission of the disease in some     patients. The purpose of this study is to evaluate intravenous outpatient infusion of     sub-anesthetic doses of ketamine for the treatment of CRPS. A thorough evaluation of this     procedure, providing information into the degree of relief and which of the constellation of     RSD symptoms are best alleviated by this procedure would result in the optimization of this     therapy for the treatment of CRPS.   "
208347|NCT00579098|"     To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be     effective in preventing short-and long-term atrial fibrillation (AF) following a left atrial     ablation procedure. We further hypothesize this reduction will result from diminished     peri-procedural inflammation, which will be reflected in lower C-Reactive Protein (CRP)     values in the blood.   "
208348|NCT00579111|"     Blood disorders such as leukemia or lymphoma or hemoglobinopathies can benefit from receiving     an allogeneic (meaning that the cells are from a donor) stem cell transplant. Stem cells are     created in the bone marrow. They grow into different types of blood cells that the body     needs, including red blood cells, white blood cells, and platelets. In a transplant, the     body's stem cells would be killed and then replaced by stem cells from the donor. Usually,     patients are given very high doses of chemotherapy (drugs which kill cancer cells) prior to     receiving a stem cell transplant. However, patients that are older, have received several     prior treatments, or have other organ diseases are at a high risk of getting life-threatening     treatment-related side effects from high doses of chemotherapy. Over the past several years,     some doctors have begun to use lower doses of chemotherapy for preparing patients for a stem     cell transplant.      A condition that can occur after a stem cell transplant from a donor is Graft Versus Host     Disease (GVHD). It is a rare but serious disorder that can strike persons whose immune system     is suppressed and have received either a blood transfusion or a bone marrow transplant.     Symptoms may include skin rash, intestinal problems similar to inflammation of the bowel and     liver dysfunction.      This research study uses a combination of lower-dose chemotherapy agents that is slightly     different from those that have been used before.      The medicines that will be used in this study are Fludarabine, Busulfan, both chemotherapy     medicines, and Campath. Campath is a monoclonal antibody (a type of substance produced in the     laboratory that binds to cancer cells). It helps the immune system see the cancer cell as     something that needs to be destroyed.      This research study will help us learn if using Fludarabine, Busulfan and Campath prior to an     allogeneic stem cell transplant can provide treatment for blood disorders while decreasing     the incidence of side effects.   "
208349|NCT00579124|"     This is a pilot study with 2 strata to evaluate engraftment and graft vs. host disease (GVHD)     in patients receiving unrelated or partially matched related donor peripheral stem cells     using the CliniMACS system to positively deplete T cells to prevent severe GVHD. Feasibility     will be tested, focusing on engraftment, treatment-related mortality (with a specific focus     on interstitial pneumonitis) and severe GVHD.   "
208350|NCT00579137|"     This study is to discover whether children with severe combined immunodeficiency disease     (SCID) or other primary immunodeficiency disorder (PID) for which no satisfactory treatment     other than stem cell transplantation (SCT) exists can be safely and effectively transplanted     from HLA mismatched (up to one haplotype) related donors or unrelated matched or mismatched     (up to one antigen) donors, when leukocytolytic monoclonal antibodies (MAb) and Fludarabine     are the sole conditioning agents. Three monoclonal antibodies will be used in combination.     Two of them are rat IgG1 (immunoglobulin G1) antibodies directed against two contiguous     epitopes on the CD45 (common leucocyte) antigen. They have been safely administered as part     of the conditioning regimen for 12 patients receiving allografts (HLA matched and mismatched)     at this center. They produce a transient depletion of >90% circulating leucocytes. The third     MAb is Campath 1H, a humanized rat anti-CD52 MAb. Campath 1H, Alemtuzumab, has been licensed     to treat B-cell chronic lymphocytic leukemia (B-CLL) and more recently has been safely given     at this and other centers as part of a sub-ablative conditioning regimen to patients with     malignant disease. Because these MAb produce both profound immunosuppression and significant,     though transient, myelodestruction we believe they may be useful as the sole conditioning     regimen in patients with SCID, in whom the use of conventional chemotherapeutic agents for     conditioning may produce or aggravate unacceptable and even lethal short term toxicity. We     anticipate MAb mediated subablative conditioning will permit engraftment in a high percentage     of these patients with little or no immediate or long term toxicity. Campath IH persists in     vivo for several days after administration and so will be present over the transplant period     to deplete donor T cells as partial GvHD prophylaxis. Additional Graft versus Host Disease     (GvHD) prophylaxis may be provided by administration of FK506.   "
208351|NCT00579150|"     This is an observational, prospective cohort study describing pregnancy outcomes in women     with pre-existing (prior to pregnancy) type 2 diabetes who have been exposed to any     formulation of exenatide during pregnancy. The pregnancy registry will compare the occurrence     of the pregnancy outcomes of interest with those collected from a prospective group of women     with pre-existing type 2 diabetes who have been exposed to one or more antidiabetic     medications other than exenatide during pregnancy. Insulin exposures are acceptable in both     groups but must be in addition to one or more other antidiabetic medications in the     non-exenatide group.      The primary study objective is to evaluate the percentage of major birth defects (i.e., those     that caused significant functional or cosmetic impairment, required surgery, or were     life-limiting) following use of exenatide during pregnancy for treatment of type 2 diabetes     compared to the percentage of major birth defects following use of one or more antidiabetic     medications other than exenatide during pregnancy for treatment of type 2 diabetes.      The secondary objectives of the Exenatide Pregnancy Registry are to evaluate the percentage     of other adverse pregnancy outcomes (e.g., spontaneous abortion, stillbirth, preterm birth)     and any potential impact of exenatide use during breastfeeding among pregnancies or births in     women who used exenatide for pre-existing type 2 diabetes:      This study is being conducted in the United States (US). Enrollment in the Registry is     voluntary. The Exenatide Pregnancy Registry is sponsored by AstraZeneca and is managed by INC     Research, LLC. The scientific conduct and analysis of the Registry is overseen by a Registry     Review Committee (RRC) consisting of experts in maternal and fetal medicine,     teratology/genetics, epidemiology, type 2 diabetes in pregnancy and/or pediatrics.   "
208352|NCT00579163|"     The purpose of this study is to better understand the genetic causes of cancer and the     inherited tendency to develop cancer. To accomplish this, blood specimens and/or saliva     samples and/or tumor and normal tissue blocks from patients and families of patients with     cancer will be collected. Blood specimens will be frozen and stored for analysis at a later     date. Tumor tissue and normal tissue will be stored for analysis at a later date. In order to     perform this study, patients and members of their families will be asked to provide blood     samples and/or saliva samples. Individuals will be asked to provide a history of cancer in     their relatives at the time the blood sample is given. No relatives will be contacted before     they have been asked by a family member if they wish to participate in this study. If they do     wish to participate, the relatives should indicate this by returning the Family Member     Consent for Contact Form After we receive this form, arrangements may be made for the family     member to send in a blood and/or saliva sample or to come in person to provide the sample to     us.      Except for family history, no medical information provided by one member of a family will be     discussed with other family members. At the end of this form, we will also ask for your     permission to be contacted in the future to discuss information about your health, additional     research with your samples and/or certain research findings possibly related to your sample.   "
208353|NCT00579189|"     The purpose of this study is to determine if a topical otic formulation is safe and effective     in treating middle ear infections in patients with ear tubes.   "
208354|NCT00579202|"     The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer     under conditions of routine clinical use for hemodialysis   "
208355|NCT00579215|"     The purpose of this study is to evaluate a new program to help the patient and the caregiver     make decisions about treatment for lung cancer. We need to know if a new information program     is helpful to patients. The way that we will do this is by comparing it with the usual     information program that we now provide.      Patient are asked to make difficult decisions about their treatments. These decisions may     include when to change treatments or when to stop treatment altogether. Most patients ask a     family member or close friend to help them with these difficult decisions. A caregiver is     someone they can count on to give support (either emotional or physical) over a period of     time. The doctors and nurses will also help patients and their caregiver to make these     decisions.      They will tell them the risks with each treatment, the success with each treatment, and how     much time there is for making each decision.   "
208356|NCT00579228|"     The purpose of this study is to look at the progression of cardiovascular disease (CVD) in     normal control individuals and in patients with controlled diabetes.   "
208357|NCT00579241|"     To Determine whether transcranial ultrasound can detect the presence of intravenously     injected microbubbles used routinely for dobutamine stress echocardiography.   "
208358|NCT00579254|"     To assess the effect of single pill therapy on the management of hypertension and other     cardiovascular risk factors (e.g., dyslipidemia) in Indian patients in whom the treating     doctor has already considered that the administration of the amlodipine/atorvastatin single     pill to be appropriate   "
208359|NCT00579267|"     The primary aims of this study are to assess:        1. The inter-rater and test-retest reliability of the MINI-KID        2. The validity of the standard MINI-KID interview in relation to the parent rated          pencil/paper version (MINI-KID-P) and th longer clinician rated Schedule for Affective          Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version          (K-SADS-PL) and expert opinion (when available).      Secondary aims will include evaluating the concordance between: The Children's Global     Assessment Scale (a required part of the K-SADS) with the clinician-rated Sheehan Disability     Scale (to be administered with the MINI-KID) as a measure of illness severity.   "
208360|NCT00579280|"     The specific aim of this study is to evaluate the efficacy, tolerability, and safety of     quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in     the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or     generalized anxiety disorder and current at least moderately severe anxiety.   "
208831|NCT00584870|"     The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared     with placebo and compared with naproxen in the treatment of adult patients with chronic low     back pain.   "
208365|NCT00579345|"     The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell     culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine     (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone and when     administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects.     The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination     with either cTIV or eTIV_a in adults and elderly subjects.   "
208366|NCT00579358|"     Congenital heart disease is one of the most common malformations in newborns. About 1% of     newborns have cardiac malformations. Many need open heart surgery, which contributes     substantially to pediatric mortality and morbidity. Recent advances in genetics suggest that     many congenital heart defects are caused by mutation of genes. So far, half a dozen genes are     found to be associated with congenital heart diseases, such as TBX5, NKX2.5, and GATA4, to     name a few. In the near future, more genes will be identified.      This study will evaluate the role of mutation of genes in congenital heart diseases and study     the genotype-phenotype correlation. The central hypothesis is that a significant percentage     of congenital heart disease is caused by mutation of genes involved in heart development, and     the phenotype with missensed mutations is milder than nonsense mutation. Another hypothesis     is that a significant proportion of patients with cardiac malformations will have mutations     in their genes. The specific aim is to test the mutations of these genes in patients with     congenital heart diseases. The study will provide substantial information to understand how     the human heart develops. In the future, prenatal diagnosis could be developed based on this     study.   "
208367|NCT00579371|"     We hypothesize that the following improvements to islet transplantation will increase the     islet mass successfully isolated and allow for engraftment from a single pancreas. The     improvements are:        -  Using Two-Layer method preservation to improve pancreas quality before islet isolation        -  Maintaining isolated islets in culture before transplantation        -  Using a steroid-free immunosuppression regimen        -  Transplanting the best combination of donor and recipient possible after HLA screening          and final crossmatching   "
208368|NCT00579384|"     The purpose of this study is to check the Effects of JNJ-26489112 on the Photic Induced     Paroxysmal electroencephalogram (EEG) Response in Patients with Photosensitive Epilepsy.   "
208369|NCT00579397|"     Objectives:        1. To show feasibility and reproducibility of performing a multiplex ligation-dependent          amplification procedure (RT-MLPA)        2. To describe the profile of changes in inflammatory gene products, using RT-MLPA, in          pediatric patients receiving stem cell transplant        3. To determine if changes in a specific inflammatory product, or a combination of          inflammatory products, can predict grade 2-4 acute graft-versus-host disease   "
208370|NCT00579410|"     The purpose of this research is to study the level of acid exposure above the     gastroesophageal junction and the distal esophagus in patients with reflux symptoms using a     capsule type acid measurement system. Patients with reflux symptoms are likely to have more     acid reflux just above the junction of the stomach and the esophagus that may help to improve     the diagnosis of gastroesophageal reflux disease (GERD). This may help better treat the     reflux symptoms.   "
208371|NCT00579423|"     This is a pilot trial designed to assess safety and immunogenicity of a multivalent conjugate     vaccine for use in patients with biochemically relapsed prostate cancer.   "
208372|NCT00579436|"     The purpose of this study is to determine whether improvement in fat and muscle metabolism     after the treatment with Omacor (fish oils) provides insight into the link between obesity,     fat and muscle function leading to metabolic syndrome, which is a risk factor for heart     disease and diabetes.   "
208373|NCT00579449|"     The purpose of this research is to evaluate the Healthy Families Durham (HFD) program by     comparing the traditional 3-year program to 18-months of Healthy Families Durham to Yearly     Visits with case management referrals to community services as usual, and to determine     whether participation in the program reduces the number of reports for child maltreatment     within the first seven years of the child's life.   "
208374|NCT00579462|"     The purpose of this study is to study whether the presence of lung cancer in your body can be     detected by testing the blood, and if the results of these blood tests change as your tumor     shrinks or grows.   "
208375|NCT00579475|"     Uterine fibroids are a benign but common condition among women in reproductive age. It is one     of the most common reasons for hysterectomy since it often causes bleeding problems sometimes     leading to anemia. Several alternative treatment regimens have been investigated that could     replace surgery. The antiprogesterone, mifepristone, is one of the most promising drugs that     have been tested. In addition to the inhibiting effect on the growth of uterine fibroids     antiprogestins have been proposed to have an antiproliferative effect on breast tissue.      The purpose of the present study is to evaluate the effect of mifepristone on the volume of     uterine fibroids. The study will also address the effect of mifepristone on the breast tissue   "
208387|NCT00579631|"     The purpose of this study is to examine the health behaviors of young adults who have been     treated for cancer, leukemia, or similar illnesses. We will also ask you some questions about     your family members' and friends' health behaviors. We plan to use the findings from this     study to design new programs to help teenage cancer survivors resist doing things that might     harm their health.   "
208388|NCT00579644|"     The purpose of this study is to determine if a combination of methotrexate and minocycline     works better than methotrexate alone in early Rheumatoid Arthritis   "
208832|NCT00584883|"     To determine the maximum tolerated dose of ABT 510 when administered concurrent with     radiation therapy for patients with newly diagnosed glioblastoma multiforme.   "
208389|NCT00579657|"     Randomized controlled single-blinded intervention study in 111 overweight and obese subjects     with risk factors of developing type 2 diabetes, with the aim to investigate effects of     isoenergetic high cereal fiber as compared with high protein diets over 6 and 18 weeks.      Proof of principle study with analysis according to study protocol, investigating whether     isoenergetic high cereal fiber and high protein diets with comparable fat contents, if     adhered to and after exclusion of known confounders such as changes in body weight, intake of     drugs with known effects on insulin sensitivity, or relevant changes in physical activity,     indeed affect insulin sensitivity.   "
208390|NCT00579670|"     To determine whether ziprasidone provides good efficacy and tolerability in the treatment of     schizophrenic Greek patients.   "
208376|NCT00579488|"     The goal of this study is to help us learn more about the roles of genes and cancers that run     in families. Sometimes, we are born with genes that are changed or altered. Gene changes are     called mutations. Mutations may be passed down from parent to child. Some mutations cause a     high risk for cancer. There are two major genes for breast and ovarian cancer. These genes     are called BRCA --for breast cancer. If you have a mutation in these genes special actions     may be needed. For a person with a known mutation, we will suggest ways to screen for cancer     or prevent it. Not everything is known about cancer genes and mutations. The cancer screening     we suggest may not always be effective. The aim of this study is to explore these questions.     If you agree we will stay in touch with you to follow your medical history. We will also ask     you about your family.      This will allow us to measure the cancer risks of known mutations. The study will also look     for other cancer genes we do not know about. Whether or not you take part in this study, you     may have gene testing. If you take part in this study and wish to know, we will tell your     BRCA gene test results.      The investigators may perform genetic testing on the blood or saliva sample in one of two     ways: analysis for mutations in the BRCA1 and BRCA2 genes alone or as part of a panel of     genes associated with breast cancer predisposition. New technologies are being employed for     identification of patients with a susceptibility for developing breast cancer and thus     analysis of multiple genes at one time may be offered to you. If this multi-gene testing     applies to the patient, a question and answer sheet about this testing will be provided to     them by their genetic counselor.   "
208377|NCT00579501|"     The purpose of this study is to evaluate the safety and efficacy of trabectedin for the     treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor     derived from primitive or embryonal lipoblastic cells).   "
208378|NCT00579514|"     The basic premise of this research proposal is to determine whether there is any significant     association between germline polymorphisms and cancers of colon, bladder, breast, testicular,     prostate, ovaries, kidney, lung, lymphoid organs, and head and neck. This is an exploratory     study designed to generate hypotheses for further research.   "
208379|NCT00579527|"     The study purpose is to determine if thymus transplantation with immunosuppression is a safe     and effective treatment for atypical complete DiGeorge anomaly. This study will also evaluate     whether thymus and parathyroid transplantation with immunosuppression is a safe and effective     treatment for atypical complete DiGeorge anomaly and hypoparathyroidism.   "
208380|NCT00579540|"     Flax seed oil, fish oil, and soy bean oil, are commonly recommended supplements for     Polycystic Ovarian Syndrome (PCOS). These oils have different chemical structures and     biological actions. It is not yet known which of these oils has the most beneficial effects     in PCOS patients because they have never been compared to each other head to head. In this     study the researchers hope to learn more about the effects of these oils on blood sugar and     insulin levels.   "
208381|NCT00579553|"     This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha     hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton     pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and     neonatal outcomes.      Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal     progesterone administered intramuscularly versus vaginally in women with singleton pregnancy     and a history of prior preterm birth.   "
208382|NCT00579566|"     The purpose of this study is to study normal and sarcoma cells. To study these cells we need     to have human tissue. You will be having or have already had a procedure to remove tissue. We     would like to use some of this tissue. We will use it for laboratory studies on the     diagnosis,behavior and treatment of sarcoma. We will perform an extensive analysis of your     samples. We will only use extra tissue left over after all needed testing has been done or     remove an additional small amount of tissue if you are having a biopsy. We will also take     blood samples before and/or after your procedure to measure biochemical factors that may help     us predict the behavior of sarcoma.   "
208383|NCT00579579|"     The purpose of this study is to find out what happens to patients after they have surgery for     rectal cancer. After being treated for rectal cancer, patients tell us that their bowel,     bladder and sexual function have changed. We are trying to understand how these changes     affect your quality of life. The research that we have now does not explain these changes or     problems very well. The patients will be asked questions about bowel function, bladder     function, sexual function, and quality of life so we can understand these changes better.     This will help us take better care of our patients in the future, before and after their     treatment for rectal cancer.   "
208384|NCT00579592|"     The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will     obviate the need for long-term calcineurin inhibitors in renal transplantation. Most     successful strategies to date have relied on the use of either tacrolimus or cyclosporine for     an indefinite period of time. However, the advantage of a long term, calcineurin inhibitor     free regimen may include improved renal allograft function, a lower incidence of     hypertension, diabetes, and less drug related side effects. This is a non-randomized     open-label pilot trial in 30 adult renal transplant patients. Subjects will receive 2 doses     of Campath-1H (30mg given on Day 0 and Day 1) and a single dose of Rituximab (375mg/m2) on     Day 0, given intra-operative. Subjects will take maintenance doses of prednisone and enteric     coated mycophenolate sodium (Myfortic™). Subject will also be given cyclosporine (Neoral®)     therapy for approximately 2 weeks (10-20 days).   "
208385|NCT00579605|"     1. Evaluate the cultural appropriateness of an intervention protocol related to: a)          motivational interviewing technique; b) stool, urine, and breast milk sample collection;          and c) infant breastfeeding test weight procedure.        2. Compare Motivational Interviewing with an attention intervention (infant safety) on: a)          breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of          breastfeeding.        3. Examine urine samples of infants for the presence of the inflammatory cytokine (LTE4)          and evaluate fecal and breast milk samples of infants for human milk oligosaccharide          levels.   "
208386|NCT00579618|"     The purpose of this study is to help us learn more about the roles of genes in cancers. Genes     are short pieces of DNA which determine the inherited characteristics that distinguish one     individual from another. This study will look at how some genes might raise or lower the     chance some people may develop cancer. The sample collection will help generate the materials     needed for this study.   "
208391|NCT00579683|"     The purpose of this study is to try to learn more about how small molecule kinase inhibitors     work in treating lung cancer. Some early studies have shown that gefitinib, erlotinib and     similar drugs are more likely to work if a particular DNA change (also known as a mutation)     is found in a protein that is important in lung cancer. This protein is called the epidermal     growth factor receptor (EGFR). Since small molecule kinase inhibitors sometimes stop working,     we would like to examine your tumor to learn why these medicines are not working as well.     Your tumor will be examined for a variety of things including changes in the DNA of the EGFR.     We will also sequence parts of the genes for HER2, HER3, HER4, and KRAS, other proteins     thought to be important in lung cancer.   "
208392|NCT00579696|"     To determine whether community based participatory action research leads to more effective     cancer prevention and control in underserved communities compared to traditional, topdown     programs.   "
208393|NCT00579709|"     The research purpose is to determine if thymus transplantation with immunosuppression is a     safe and effective treatment for complete DiGeorge anomaly. The research includes studies to     evaluate whether thymus transplantation results in complete DiGeorge anomaly subjects     developing a normal immune system.   "
208394|NCT00579735|"     Patients who received breast MRI will be evaluated for a variety of indications including : #     each indication : 1) known cancer staging for local exent, 2)high risk, 3)high suspicion     clinical finding, 4)questionable mammo finding, 5)silicone leak The number of incidental     lesions not detected by any other method that were subsequently subjected to biopsy with the     following BIRADS categories 3−# reasons for bx 4−# 5−# Of the lesions detected % of each     BIRADS category were postive histologies−ductal, lobular, DCIS, etc. and negative (fibrosis,     hyperplasia, etc.) Criteria for classification: morphology, dynamics, clinical significance     will be evaluated and a predictive value established.   "
208395|NCT00579748|"     Optical coherence tomography (OCT) is a non-invasive imaging technique that uses light to     create pictures of living tissues and has been successfully used to generate high resolution     cross-sectional images of tissue in the human eye and skin. OCT systems are now commercially     available for eye and skin use, and several clinical reports on the use of OCT in the     gastrointestinal tract have been published as well.      The purpose of this study is to develop a high-speed noninvasive OCT probe which can be     placed through an endoscope for the early diagnosis of pre-cancerous and cancerous lesions in     the gastrointestinal tract. This is a pilot clinical research study that is designed to     advance OCT technology, which may in the future be able to replace or augment endoscopic     biopsies.   "
208396|NCT00579761|"     This is an analysis of the outcomes of patients having undergone surgical intervention for     infective endocarditis.   "
208397|NCT00579774|"     Advanced glycation products or AGEs are a heterogeneous group of molecules formed by exposure     of tissue constituents to high levels of reducing sugars, e.g. glucose. The interaction of     these compounds with extra- and intra-cellular components may account in part for several     conditions related to aging. It has recently been recognized that AGEs are also formed during     the preparation of food by heating, are absorbed into the circulation and become largely     incorporated into tissue components. Accumulation of these exogenous substances over time     may, together with those generated endogenously, contribute to the clinical manifestations     and complications of aging.      This is an interventional-randomized study in which we are trying to determine whether a diet     low in AGE can effectively reduce circulating AGE levels, with or without altering oxidation     or inflammatory markers, in a subset of both young and older subjects , over a period of 4     months. If positive results are obtained, longer-term prospective studies will be designed to     determine if this intervention can affect disease outcomes in older age subjects.      The study design is very simple and consists initially of obtaining a dietary history, a     blood sample, 24-hour urine collection and, subsequently, of determining the effects of a     low-AGE diet for 4 months on the plasma levels of these compounds in a group of healthy     subjects.   "
208398|NCT00579787|"     The purpose of this study is to will help us understand how two treatments impact women with     early stage cervical cancer: a radical hysterectomy, which removes the entire uterus, the     ovaries, and fallopian tubes versus a radical trachelectomy which removes the cervix, which     is the bottom part of the uterus. The second leaves the rest of the uterus, the ovaries, and     fallopian tubes. This means that there is a chance that the woman might be able to get     pregnant in the future with this type of treatment. We believe that these two operations need     further study to see how they impact women. This study will look at emotions and issues of     fertility. The study will also ask about quality of life and sexual functioning. What we     learn from this study will help us give better information to women considering these     treatments.   "
208399|NCT00579800|"     The purpose of this study is to evaluate new computer software on breast magnetic resonance     imaging (MRI). The information from this study may help doctors and scientists develop better     ways to find breast cancer, and may help future patents with cancer.   "
208400|NCT00579813|"     The purpose of this study is to better understand the link between obesity and diabetes or     pre-diabetes.   "
208401|NCT00579826|"     This is a multi-institution double-blind placebo-controlled trial whose main objective is to     determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by     Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have     random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or     borderline atypia, and a minimum Ki-67 of >1.5%.      The primary hypothesis is that proliferation and expression of other estrogen response genes     will be favorably modulated by six months of letrozole relative to placebo without     substantially increasing hot flashes or worsening overall quality of life.   "
208403|NCT00579852|"     The purpose of this study is to compare the results of two CT scans of the chest performed     within minutes of each other. We will compare several different measurements of lung cancer     tumors. This study will help show whether we can get accurate results when we compare     measurements on different CT scans. This information is important for patients with cancer,     who often have more than one CT scan during their treatment.   "
208404|NCT00579865|"     You may have symptoms like itching, abdominal pain, loss of appetite, fatigue, fevers and     chills. The treatment you will receive to relieve the blockage is also intended to relieve     symptoms and improve your quality of life. The purpose of this study is to find out if     relieving the blockage in your bile duct improves your quality of life.   "
208406|NCT00579891|"     To establish a serum and tissue bank with specimens form patients with colorectal cancer, for     subsequent immunological and biochemical analysis.   "
208407|NCT00579904|"     The purpose of this study is to learn more about the effects of walnuts, walnut-oil, almonds     and fish oils on blood sugar and insulin levels in polycystic ovary syndrome (PCOS) patients.     The hypothesis is that a diet rich in these foods will improve insulin resistance in women     with PCOS.   "
208408|NCT00579917|"     The purpose of this study is to understand how to help survivors of bone marrow transplant     and stem cell transplant (BMT/SCT) with emotional distress. BMT/SCT has become a more common     type of treatment for cancer or hematological disorder (blood disease). For this reason,     there is concern that adjustment after treatment may be difficult for many persons. We have     found that about 25% of BMT/SCT survivors still feel anxious and distressed about their     illness and its treatment after at least one year following transplant. This study is one of     the first to study the impact of counseling on BMT/SCT survivors. The study is being carried     out at Memorial Sloan-Kettering Cancer Center, Mount Sinai Medical Center, and Hackensack     University Medical Center.   "
208409|NCT00579930|"     To establish a serial ascertainement of specimens from patients with bone sarcomas to be used     in ongoing cytogenetic and molecular genetic analyses. These data will be integrated and     correlated with the established Orthopaedic Service clinical database.   "
208410|NCT00579943|"     Advances in newborn intensive care have lead to dramatic improvements in survival for the     most premature infants—often weighing 1 pound at birth. Unfortunately, cerebral palsy, mental     retardation, and developmental delay affect more than 10,000 of these premature infants in     the U.S. annually. In his studies, Dr. Jeffrey R. Kaiser is trying to understand why these     premature infants are at such high risk of brain injury, and to learn ways to prevent injury.     Experts believe that disturbances of brain blood flow regulation are important in causing     these injuries. Using a novel continuous monitoring system, Dr. Kaiser is able to determine     an infant's capacity for normal brain blood flow regulation. Contrary to previous thinking,     he has shown that many of these babies in fact due have normal regulation of their brain     blood flow. He has observed that brain blood flow may be disturbed during suctioning of the     breathing tube. Further, he has also shown that infants with high carbon dioxide, those not     breathing well, have impaired regulation of their brain blood flow. Thus, even stable infants     are prone to disturbed brain regulation during routine intensive care, which may lead to     bleeding in the brain and long-term neurologic problems. Dr. Kaiser will study up to 200     infants to determine 1) the developmental pattern of normal regulation of cerebral blood     flow; 2) in those with impaired regulation, determine when it develops during the first week     of life; and 3) determine the relationship between impaired brain blood flow regulation and     brain injury. Results from this study will help us recognize when premature infants are most     vulnerable to developing brain injury, allowing prevention and intervention strategies to be     initiated in a timely fashion.   "
208411|NCT00579956|"     Melioidosis, an infection caused by the bacterium Burkholderia pseudomallei, is a major cause     of community-acquired septicaemia in northeast Thailand. Common manifestations include     cavitating pneumonia, hepatic and splenic abscesses, and soft tissue and joint infections.     Despite improvements in diagnostic procedures and treatment, the mortality of severe     melioidosis remains unacceptably high - approximately 35% with currently used antibiotics     (ceftazidime or co-amoxiclav). There is clear evidence that antibiotics can affect mortality;     the use of ceftazidime rather than previous regimens (doxycycline + chloramphenicol +     co-trimoxazole) led to a 50% reduction in mortality from 80% to 35%. However, the mortality     in the first 48 hours has not been altered by any treatment regimen. A key question is     whether alternative antibiotics could improve early outcome. The hypothesis tested is that     meropenem is superior to ceftazidime in terms of mortality for the treatment of melioidosis.   "
208412|NCT00579969|"     The primary purpose of this study is to show, through a controlled masked clinical study of     subjects with ocular hypertension (OHT), that latanoprost increases the low uveoscleral     drainage of aqueous humor back to normal levels, and timolol maleate reduces the formation of     aqueous humor below normal. Both of these mechanisms will effectively reduce intraocular     pressure (IOP).      The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the     fluorophotometric outflow facility, and episcleral venous pressure and on all parameters over     time.   "
208413|NCT00579982|"     To determine the convenience and satisfaction of new orally disintegrating tablet formulation     (ODT) of lamictal in subjects with a mood disorder. This was a multicenter, open-label study     in participants with a mood disorder, who reported difficulty or discomfort in swallowing the     currently marketed IR compressed tablet formulation of lamotrigine and who had a person (such     as a spouse, partner, companion, aid, nurse, caregiver, etc) willing to complete a     Companion/Caregiver Question. Subjects were switched from the currently marketed lamotrigine     IR formulation to a matching dose of lamotrigine IR orally disintegrating tablet (ODT) for 3     weeks to determine convenience and satisfaction.   "
208414|NCT00579995|"     The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous     sodium bicarbonate for the prevention of CIN after cardiac catheterization.   "
208415|NCT00580008|"     The purpose of clinical research is to look at the nature of disease and try to develop     improved methods to diagnose and treat disease.The goal of this study is to evaluate the use     of computed tomography (CT) scan of the heart in the diagnosis of disease in vein grafts     after bypass surgery.   "
208416|NCT00580021|"     Compare the clinical characteristics and post-surgical outcomes (overall survival)of     pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in     BRCA1 or BRCA2 .      Compare the clinical characteristics and outcomes (time to progression) of breast cancer     patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2     receiving paclitaxel chemotherapy for metastatic disease.   "
208431|NCT00580216|"     The objective is to evaluate whether once weekly subcutaneous (SC) injection of     idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots     in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose     warfarin in patients with atrial fibrillation (AF).   "
208692|NCT00583050|"     The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the     exclusion of abdominal aortic and thoracoabdominal aneurysms.   "
208417|NCT00580034|"     Allogeneic transplantation is used to treat many malignant and non-malignant diseases, though     the potential toxicities of the procedure remain high. We and others have shown that a less     toxic preparative regimen allows reliable allogeneic engraftment for allogeneic     transplantation.      The primary purpose of this treatment trial is to follow patients undergoing allogeneic     transplantation for long term outcomes. The regimen used has been tested in our prior phase I     / II trial which has completed accrual. The issues of engraftment and rate of graft versus     host disease have been answered and our success has led to this regimen being a standard     approach for less toxic allogeneic therapy.   "
208418|NCT00580047|"     The study is designed to look at the effect of different bone treatment plans on bone loss     after kidney or kidney/pancreas transplant.   "
208419|NCT00580060|"     This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide     vaccination in patients with metastatic melanoma. The objective of this study is to determine     the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a     multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC     stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA     is safe and generates an immune response to peptides derived from antigens on melanoma cells.   "
208420|NCT00580073|"     This study involves the use of Oxaliplatin, 5-Fluorouracil (5-FU), Leucovorin and Cetuximab,     which are all medicines approved by the Food and Drug Administration (FDA) and are     commercially available. This treatment regimen will possibly be combined with radiation     before and/or after surgery depending on your response to the treatment. Their use in this     exact combination is considered experimental. The purpose of this study is to find out how     effective this combination of chemotherapy is as treatment for rectal cancer that has not     spread to other parts of the body. The side effects and survival experienced by subjects     receiving these drugs will also be evaluated. This is a phase II research study.   "
208421|NCT00580086|"     This study is being done to evaluate if MR spectroscopy will give us more information about     whether or not your chemotherapy will work for you. Spectroscopy is a special set of pictures     taken with Magnetic Resonance Imaging (MRI) that gives us information about the chemical     composition of your breast cancer.   "
208422|NCT00580099|"     Briefly our study is looking at the effects of 4 weeks of assisted exercise on the body     composition and neurological/behavioral development of healthy growing premature infants     enrolled between the ages of 30-33 weeks. It is a blinded study where the active group gets     the exercise intervention and the control group is cuddled for the same amount of time     -approximately 20 minutes. We get baseline data using muscle ultrasound, bone speed of sound     and DEXA. We also get baseline blood samples to look at inflammatory mediators and growth     hormone. Video of each subject is recorded an hour at two time points during the study to     assess the babies for spontaneous activity. Nutritional intake information is collected daily     and in the 4th week of the study assessments made for total energy expenditure using doubly     labeled water. At this point in the study we repeat the ultrasounds and DEXA for comparison.     Finally in the period just before discharge we do a complex neurological exam using the     Brazelton NBAS assessment.   "
208423|NCT00580112|"     The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3     subpopulations of participants with previously treated progressive metastatic ( spread of a     cancer from one organ or part to another non-adjacent organ or part) breast cancer (abnormal     tissue that grows and spreads in the body until it kills) participants.   "
208424|NCT00580125|"     The objective of this study is demonstrate efficacy and a dose-response in the treatment of     acute exacerbation of schizophrenia in comparison to placebo.   "
208425|NCT00580138|"     The purpose of this study is to determine whether real-time internet evaluations of     swallowing, or x-ray swallow studies viewed over closed internet circuit, are a reliable     method of evaluating swallowing function.   "
208426|NCT00580151|"     Some of the children who suffer acute burn injury do not have adequate pain and anxiety     management with the current regimen of scheduled opiates (morphine) and benzodiazepines     (lorazepam). Other children have significant side effects or contraindications, such as     constipation or over sedation, when taking these medications. Clonidine is known to reduce     the need for morphine in the management of postoperative pain. The addition of clonidine to     the pharmacological treatment of burn wound pain offers a possible adjunct to the standard     opiate and benzodiazepines regimen. Clonidine has been used in children in both on a     short-term basis (such as postoperative pain management) and on a long-term basis (such as     the treatment of attention deficit hyperactivity disorder (ADHD)). This study tests the     hypothesis that clonidine in a dose of 5 ug/kilo every 8 hours will be a useful adjunct to     the management of pain and anxiety in the acutely burned child. All children will be treated     by protocol with morphine (0.03mg/kilo) q4hr prn pain and lorazepam (0.03 mg/kilo) q 4 hours     prn anxiety. In addition, after informed consent is obtained the children will be randomized     to the addition clonidine or placebo. Pain and anxiety will be assessed using standard     instruments blind to the medication being used on a daily basis Also the total dose of     morphine and lorazepam during the 10 days of added clonidine or placebo will be recorded..     The pain rating, anxiety ratings, total morphine dose, and total lorazepam dose will be     compared between the placebo and clonidine groups with a Student's t test. Once the blind is     broken the child will be allowed to remain on the clonidine if it is beneficial. The second     year of the grant will expand the age groups down to younger children and also begin to gain     information about the effect of clonidine on the hypermetabolic state secondary to burn     injury.   "
208427|NCT00580164|"     This study is attempting to understand whether or not splinting after a fingertip injury     improves recovery.   "
208428|NCT00580177|"     Three different techniques for the surgical repair of groin hernias are compared. Focus has     been set on operation times, time to full return of functional abilities like walking in     stairs etc, and if any technique has more complications than the others. Three years results     are presented in the study.   "
208429|NCT00580190|"     PF-00572778, a CRH antagonist, is expected to attenuate adrenocorticotropin (ACTH) and     cortisol responses to naloxone by blocking the effect of the CRH increases induced by     naloxone at the postsynaptic receptors. Demonstration of a statistically significant     attenuation of naloxone induced increases in cortisol and/or ACTH concentrations by     PF-00572778 compared to placebo would thus constitute proof of mechanism for the compound.     Therefore, this study is to evaluate pharmacodynamic effects of PF-00572778 following     naloxone challenge in healthy subjects.   "
208430|NCT00580203|"     This is a protocol to collect tissues, blood, and other specimens from patients with     malignant or nonmalignant diseases of the head and neck. Collected specimens will be used in     laboratory studies to investigate the growth, development, and transformation of normal and     abnormal cells in the future.   "
208693|NCT00583063|"     Determine the pharmacokinetic interactions between rapamycin and sunitinib in patients with     advanced solid tumors.   "
208432|NCT00580229|"     This study will be an open-label prospective analysis of oral prednisone (compared to IV     methylprednisolone) as a pre-treatment for rituximab in patients with rheumatoid arthritis.     The study will be useful as pilot data to establish that there are no different trends     between the two treatment strategies at decreasing the frequency and severity of acute     infusion reactions. It would also establish proof of principle that pre-treatment with oral     prednisone is equally as efficacious as IV methylprednisolone.      The primary endpoint will be to assess the safety and tolerability of rituximab (Rituxan) in     RA.      By showing that there are no differences in the frequency or severity of acute infusion     reactions after rituximab when using pre-treatment with oral prednisone compared to I.V.     methylprednisolone, we will establish proof of principle that oral prednisone is a viable     alternative to I.V. methylprednisolone. Pre-treatment with oral prednisone would be a     practical advantage for both the patient and the treating physician. The patient could     self-administer this treatment at home thereby decreasing the time they would need to spend     at the infusion center. Further, this dose of prednisone has fewer side effects than 100mg of     methylprednisolone.   "
208433|NCT00580242|"     This study proposes using bortezomib in cohorts of 3-6 patients at the doses of 0.7, 1, and     1.3 mg/m2 on days 1, 4, 8, and 11 to determine the MTD in combination with lenalidomide 10 mg     a day, for 21 days of a 28 day treatment cycle for patients with myelodysplastic syndrome.   "
208434|NCT00580255|"     It is hypothesized that elevated BNP level correlate with an elevated thoracic     impedance/fluid index as measured separately by CRT-D devices and external impedance     cardiography. Ultimately, it is also hypothesized that both BNP and thoracic impedance/fluid     index measurements are predictive of atrial and ventricular arrhythmias.   "
208435|NCT00580268|"     The purpose of this study is to examine risk factors for relapse of bipolar disorder during     pregnancy and the postpartum period. The main goal of this study is to find the risks that     may make it more likely for a woman with bipolar disorder to experience a depressive, manic,     or hypomanic episode during her pregnancy and the postpartum period.   "
208436|NCT00580281|"     The drug that you are taking for your cancer, imatinib (GleevecTM), has recently been shown     to have some new types of side effects. In some people, imatinib can affect how bones are     made.      The purpose of this study is to find out if imatinib is causing these side effects in you. We     can check how your bones form by testing your blood and urine. We can also check your bone     strength by doing a special X-ray of your bone called bone density (or DEXA scan).   "
208437|NCT00580294|"     The purpose of this study is to see if changing from one pain medication like morphine or     oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This     study will examine if the switching from one pain medication to another can be done over a 24     hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of     severe pain.   "
208438|NCT00580307|"     Objective: To determine the efficacy of surgical correction of intranasal mucosal contact     points in improving quality of life and decreasing medication use in patients with rhinogenic     headaches.   "
208439|NCT00580320|"     Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma.     Weekly administration of the combination will prove to be feasible and tolerable at an     appropriate dose.   "
208440|NCT00580333|"     The purpose of this study is to find out what effect taking cisplatin in combination with     bevacizumab before surgery and then standard chemotherapy plus bevacizumab after surgery will     have on participants with Estrogen Receptor (ER) negative, Progesterone Receptor (PR)     negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer.     Cisplatin is used to destroy cancer cells in many types of cancers, and has shown to be     effective and have manageable side effects. Bevacizumab is an antibody, which is a protein     that attacks a foreign substance in the body. Bevacizumab slows or stops cell growth in     cancerous tumors by decreasing the blood supply to the tumors.   "
208441|NCT00580346|"     People who aspirate after neurologic insults such as stroke often develop fatal pneumonia.     This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed     over the chest wall are connected to electrodes placed around the nerve that closes the vocal     cords. The patient triggers closure by flipping the switch of a coil taped over the skin     covering the internal stimulator. Vocal cord motion is verified by videotaping through an     endoscope, and the status of swallowing is documented radiologically by a modified barium     swallow.   "
208442|NCT00580359|"     This study is an open-label, single-center, and randomized phase II study designed to     evaluate each efficacy and safety of S-1 and capecitabine in the elderly and/or poor     performance status patients with recurrent or metastatic gastric cancer. The randomization     will be stratified by age (70-85 years versus 65 years and < 70 years) and performance     status, which is dependent on age group; in 70-85 years, ECOG performance status 0-1 versus 2     and in ³65 years and <70 years, ECOG performance status 2 versus 3.        -  S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)        -  Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Treatment          will be administered every 3 weeks and will be continued in the absence of disease          progression or unacceptable toxicity.   "
208443|NCT00580372|"     This experimental study evaluates the effects of a series of intensive drug regimens as     initial treatment for Multiple Myeloma followed by 2 bone marrow transplantations 4─6 months     apart in support of high─dose Melphalan, followed by Interferon treatment indefinitely.   "
208538|NCT00571974|"     Oral leukoplakia within the mouth is a visible white patch which can develop into cancer if     not treated. There is no good treatment for these lesions, apart from surgery which is     associated with significant side effects and physical deformation of the treated area.      The investigators hypothesized that photodynamic therapy can be used safely and effectively     to induce significant regression of oral leukoplakia.   "
208444|NCT00580385|"     The purpose of this study is to investigate tumors in the laboratory to determine how and why     they respond, or fail to respond to different drug therapies. This study will also     investigate why high pressure develops within tumors and how this affects how well drugs     work. We will also take blood samples before and/or after your procedure to measure     biochemical factors that may help us predict the behavior of osteogenic sarcoma and other     solid tumors.   "
208837|NCT00584948|"     The purpose of this study is to determine if memantine is effective in treating symptoms of     Fragile X-associated Tremor Ataxia Syndrome.   "
208445|NCT00580398|"     The primary aim of the proposed study is to develop and assess the feasibility of delivering     a smoking cessation intervention to patients undergoing lung surgery that begins before     surgery and continues up to 3 months post-discharge. The secondary aim is to assess smoking     cessation rates 3 months following surgery.   "
208446|NCT00580411|"     This study is an epidemiological and descriptive study of the lifetime relationship of     insomnia to alcohol problems.   "
208447|NCT00580424|"     We propose a prospective cohort study to assess the effect of the progesterone only     contraceptive pill (minipill) on coagulation parameters known to be associated with risk of     thrombosis (blood clots) in women who are at increased risk for forming blood clots. We plan     to recruit women with a history of venous thromboembolism (VTE, blood clot in a vein) and     women with a history of blood tests which demonstrate an increased risk of thrombosis who     desire contraception.      Women enrolled in this study will undergo phlebotomy (blood draw) at baseline (prior to     starting the minipill), one and three months. Stored samples will be used to measure D-dimer,     C-reactive protein (CRP), antithrombin (AT), factor VIII, free and total protein S,     fibrinogen, von Willebrand factor (vWF) and normalized activated protein C sensitivity ratio     (nAPCsr). Both groups will undergo a general physical and GYN exam prior to enrollment. This     exam and the blood testing will be provided free of charge. Patients will not be prescribed     the minipill after completion of the study and will be advised to consult with their primary     care physician or hematologist if they wish to continue this medication.   "
208448|NCT00580437|"     Examine the clinical utility of the dobutamine stress contrast echoes and angiograms obtained     routinely in the evaluation of patients prior to kidney or pancreas transplantation.   "
208449|NCT00580450|"     The purpose of this trial is to determine safety and efficacy of 16 weeks treatment with     thymosin alpha 1 given at 1.6 mg dose once daily by subcutaneous injection in adult patients     with hematological undergone allogenic bone marrow transplantation and CMV positive.      The efficacy will be explored assessing the ability of thymosin alpha1 to prevent the     infection complications.   "
208450|NCT00580463|"     The purpose of the study is to collect samples of brain or spine tumors. Memorial     Sloan-Kettering Cancer Center would then store them for use by researchers who study brain or     spine cancer and try to find better ways of treating it. We will also collect blood and     spinal fluid from patients with brain or spine tumors. The blood and spinal fluids are also     used for research studies of cancer and its treatment.   "
208451|NCT00580476|"     The goal of this study is to learn more about how we measure depression in elderly cancer     patients (patients aged 70 and older). Depression is one of the most common causes of     emotional distress in the elderly and continues to be under-recognized. This is a problem     because depression can have a negative impact on quality of life. The symptoms of depression     are linked to poor health outcomes and higher costs of health care. In fact, depression is     one of the top five concerns facing the elderly today.   "
208452|NCT00580489|"     The study is exempt from informed consent by the MetroHealth Medical Center institutional     review board (IRB), because two standards of care are used and there is no increased clinical     risk to the patient due to the study. The researchers randomize either fentanyl or morphine     to be given to trauma patients and record how their pain scale is treated along with     observing for adverse events. They are looking to see if the hypothesized benefits of     fentanyl (which is much more expensive than morphine) actually exist.   "
208453|NCT00580502|"     This study is to evaluate the safety and efficacy of Gastric Banding for patients with body     mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.   "
208454|NCT00580515|"     The purpose of this study is to learn how well family therapy works if given while a family     member is being treated for a serious illness and whether it helps their family to continue     meeting for a time after their death. The therapy aims to assist the family communication and     support during both palliative care and bereavement. The investigators also want to learn how     many family therapy sessions spread out over time are best for helping patients and their     families.      Patients are randomly assigned to one of three groups: patients who receive standard     palliative care, patients and their families who take part in 6 sessions, and patients and     their families who take part in 10 sessions.   "
208455|NCT00580528|"     The purpose of this study is to evaluate the effectiveness of a theory-based intervention     tailored to constructs in the Health Promotion Model and delivered by two distance modes to     achieve improvement in healthy eating and physical activity for the control of blood pressure     (BP) among an underserved and vulnerable population of prehypertensive rural women aged 50 to     69.   "
208456|NCT00580541|"     Increased dietary variety has been shown to increase intake in animals, as well as humans, as     compared to a diet or meal composed of one food. While most studies investigating dietary     variety have focused on energy-dense foods (i.e., snack foods) and have emphasized the     negative component that variety has on intake, very little research has been conducted with     variety to determine if this food characteristic can be used to increase consumption of     healthy foods (i.e., fruits). We hypothesize that increasing variety of fruits provided in an     eating bout will lead to increased intake of these foods. Therefore, the aim of this     investigation is to test the environmental factor of variety on fruit intake in males and     females aged 18 to 45 years.   "
208484|NCT00580918|"     The purpose of this study will be to assess the attentional ability of patients with mild to     moderate traumatic brain injury (TBI) using the functional Magnetic Resonance Imaging (fMRI)     technique. Methodology for specific aim 1: sagittal pilot scan, 3-D anatomical MRI, Whole     brain echo-planar imaging (EPI), and functional MRI techniques with traumatic brain injured     subjects doing a Continuous Performance Test (CPT) attention task and compare the pattern of     activation with those of normal controls to see if there is a failure to activate frontal     lobes in the traumatic brain injured subjects.   "
208485|NCT00580931|"     The purpose of this study is to determine whether nicotinamide, or vitamin B3, is safe and     effective in the treatment of Alzheimer's disease.   "
208594|NCT00572741|"     Hypothesis: Many children with autism have impaired methylation and     antioxidant/detoxification capacity and chronic oxidative stress. A targeted nutritional     intervention that is designed to correct the metabolic imbalance will normalize their     metabolic profile and improve measures of autistic behavior.   "
208457|NCT00580567|"     The purpose of the this study is to compare pathological gamblers versus non-pathological     gamblers using tests that measure different components of impulsivity. We aim to invite a     total of 120 individuals to participate in this study.      Impulsivity has been described as the cognitive inability to delay gratification, a failure     to inhibit behavioral action or acting without forethought about consequences. Impulsivity     has also been seen as a personality trait characterized by risk-taking or sensation seeking     behavior. Pathological gamblers demonstrate aspects of impulsivity; they act without     thinking, have difficult inhibiting urges to gamble and desire immediate gratification. The     goal of this project is to clarify which components of impulsivity are associated with     pathological gambling. Non-treatment seeking, pathological gamblers and controls will be     recruited from the community and local casinos. Each participant will be administered a     battery of tests that represent different operational definitions of impulsivity.   "
208458|NCT00580580|"     To detect coronary artery disease by both coronary and carotid artery imaging and myocardial     perfusion imaging using a new low mechanical index real time system.   "
208459|NCT00580593|"     The goal of this trial is to determine the feasibility of conducting a randomized,     double-blind, placebo-controlled trial of nocturnal noninvasive positive pressure ventilation     in persons with amyotrophic lateral sclerosis with an forced vital capacity greater than or     equal to 50 percent.   "
208460|NCT00580606|"     The purpose of this study is to evaluate the safety and immune response to daily sublingual     (under the tongue) immunotherapy (SLIT) with peanut extract in adults and children with     peanut allergies.   "
208461|NCT00580619|"     The investigators propose to test the hypothesis that the sympathetic nervous system     contributes to the cardiovascular and inflammatory abnormalities present in the chronic     fatigue syndrome (CFS) and, in particular in the subset of patients characterized by postural     tachycardia syndrome (POTS). CFS and POTS are seen mostly in otherwise normal young women,     and are the cause of significant disability. A substantial proportion of patients referred     for evaluation of POTS met diagnostic criteria for CFS and, conversely, a subset of patients     referred for treatment for CFS have POTS. The investigators hypothesize that sympathetic     activation underlies the pathophysiology of patients in whom CFS and POTS overlap (CFS-P).   "
208462|NCT00580632|"     In Spain, there is little data available concerning the evolution and treatment of Psoriatic     Arthritis by rheumatologists and dermatologists. This study is designed to obtain more data     about the clinical and therapeutic management of Psoriatic Arthritis in Dermatology and     Rheumatology Medical centers.   "
208463|NCT00580645|"     The purpose of this study is to examine the effect of smoking cessation medications on     alcohol drinking.      Following 7 days of medication pre-treatment to achieve steady state levels, participants     complete a laboratory session assessing alcohol self-administration behavior and a cue     reactivity session assessing their reactivity to alcohol-related cues. Subjects are     maintained on study medication for 4 weeks after the laboratory session.      The study is subdivided into three studies based on subject population.      Study 1A enrolls heavy drinking smokers (tested under nicotine deprivation). Study 1B enrolls     heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and     nonsmokers. Study 1C enrolls smokers (not tested under nicotine deprivation) and nonsmokers     who meet criteria for alcohol use disorders.      In Study 1A, volunteers are administered either varenicline (Chantix), bupropion (Zyban), or     placebo. In Studies 1B and 1C, volunteers are administered either varenicline (Chantix) or     placebo.   "
208464|NCT00580658|"     The purpose of this study is to allow patients to undergo deep brain stimulation (DBS)     surgery for the treatment of dystonia. This is NOT a research study, but rather, a     requirement by the FDA for humanitarian use of the deep brain stimulator device in the     treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by     the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including     generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in     patients 7 years or older. Thus, this proposal request authorization by the IRB to allow     patients at VUMC to access this HUD therapy.   "
208465|NCT00580671|"     Marijuana remains the most prevalent illicit substance used by adolescents and the number of     adolescents receiving treatment for marijuana abuse more than tripled during the last decade.     A small number of clinical trials suggest that family-based and individual interventions have     efficacy for treating adolescent substance abuse. However, even with these interventions most     adolescents fail to reduce their substance use substantially, thus, there remains much room     for improvement of treatment services. The overarching goal of this project is to develop and     test novel behavioral treatments to enhance treatment outcome in this important treatment     population, and in so doing, learn more about mechanisms of change that have broader     implications for addiction science. In our initial Stage IB project Behavioral Treatment for     Adolescent Marijuana Abuse, we created, manualized, and pilot tested a unique     contingency-management (CM) intervention that combined abstinence-based voucher incentives     with contingency management training for parents. A small randomized, clinical trial provided     encouraging results. When added to a commonly used cognitive-behavior therapy, CM improved     rates of sustained abstinence during treatment. Adolescents receiving this intervention were     less likely to relapse over the 9-month follow-up period, however this finding was not as     robust as the observed during treatment effects, most likely due to the small sample size and     associated low power to detect effects. Despite strong indicators of the efficacy of this CM     intervention, there remained room for improvement in increasing rates of treatment response     and reducing rates of relapse. Hypothesized mediators and moderators of change indicated that     changes in parenting had direct effects on post-treatment marijuana abstinence outcomes, and     that abstinence early in treatment was a robust predictor of the CM treatment effect. This     proposal will systematically replicate and extend these findings. A Stage II trial will     compare three treatment conditions: (1) cognitive behavior therapy (CBT only); (2) CBT plus     CM; and (3) CBT plus an enhanced CM model targeting increased early abstinence rates,     parenting skills, and maintenance of effects. Replicating the initial demonstration of the     positive effects of CM will extend the scientific evidence for use of CM to increase     treatment efficacy for substance-abusing adolescents. Testing an enhanced CM model will     determine if modifications that are consistent with the underlying behavioral principles and     empiricism supporting CM interventions can result in improved outcomes. Last, assessment of     potential mechanisms of action, particularly parenting, adolescent psychopathology and     impulsivity, will provide scientific information directly relevant to future development of     more effective intervention and prevention models of adolescent substance abuse, and will     inform us about fundamental mechanisms operating in drug-dependence.   "
208466|NCT00580684|"     To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal     carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the     rate of penicillin-resistant pneumococci in nasopharyngeal carriage.   "
208467|NCT00580697|"     This study is to determine the prevalence of lower urinary tract symptoms in women undergoing     surgery for gynecologic malignancy.   "
208508|NCT00581230|"     The purpose of this study is to determine if the Rapid Airway Management Positioner (RAMP,     AirPal, Center Valley, PA) is a useful positioning device for direct laryngoscopy and     tracheal intubation in obese patients undergoing gastric bypass or laparoscopic gastric     banding surgery.   "
216759|NCT00687960|"     This study tested the effects of resistant starch type 4 on blood sugar and hunger in young     adults with Type 2 diabetes.   "
208468|NCT00580710|"     This study is designed to investigate the effects of diabetes mellitus and its treatment upon     the body's responses to low blood glucose (blood sugar) levels. Diabetes is a medical     condition in which blood glucose can rise very high. Treatment of diabetes mellitus involves     giving insulin (a hormone), which can occasionally cause blood glucose to fall too low. The     body responds to low glucose levels by producing a number of hormones, which act against the     insulin to help correct the low blood glucose. These hormones also provide symptoms which     warn that the glucose is falling too far. These protective warnings by the body may be     different in people with diabetes. We want to test whether this also means that diabetes     changes the sensitivity of brain function to a lowering of blood glucose levels. In order to     answer this question, we need to compare the response of people with diabetes with the     response of people who do not have diabetes.      The plan of the study is to lower the subject's blood glucose using insulin, while measuring     what changes occur in brain function using what is called functional magnetic resonance     imaging (fMRI).   "
208469|NCT00580723|"     The purpose of this open-label study is to determine the tolerance and efficacy of     twice-daily application of PRK 124 (Pyratine-6)(0.125%) moisturizing lotion for improving the     signs and symptoms of mild to moderate facial rosacea.   "
208470|NCT00580736|"     The research hypothesis is that topical application of a mixture of pre-polymers of     polypropylene glycol and polyethylene glycol (an optical clearing agent) will reduce skin     light scattering, increasing the amount of light reaching the target for diagnostic as well     as therapeutic purposes.   "
208471|NCT00580749|"     We will compare the two types of enteral (intestinal) nutrition in regard to patients with     severe acute pancreatitis in our institution and also in 8 others in the United States.   "
208472|NCT00580762|"     This study will address a true clinical problem by developing a risk/benefit analysis for     rapid surgical weight loss in the ESRD population. The risks of surgical intervention, as     well as, potential nutritional concerns, balanced with that of the potential medical benefits     associated with significant weight loss.   "
208473|NCT00580775|"     As an ancillary study to the KEEPS study (see ClinicalTrials.gov Identifier: NCT00154180),     the primary purpose is to measure effects of estrogen vs. placebo in menopausal women, on     autonomic function and repolarization; both measured non-invasively via holter monitoring.   "
208474|NCT00580788|"     This is a dose escalation study to determine the maximum tolerable dose of Parathyroid     Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators     plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and     progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy     (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally,     the investigators will assess the direct influence of PTHrp on markers of bone turnover, and     plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.   "
208475|NCT00580801|"     The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C     Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is,     pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with     antiretroviral therapy) participants.   "
208476|NCT00580814|"     The purpose of the study is to investigate the functional state of dopamine cells and the     dopamine transporter in ADHD subjects and controls to assess the effects of chronic     methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD     subjects.   "
208477|NCT00580827|"     This 18-week, randomized, double blind clinical trial provided treatment for 160     cocaine-dependent opioid addicts, aged 18-65 years. Participants were stabilized on LAAM     maintenance during the first 4 weeks and cocaine use was assessed; participants were then     stratified by level of cocaine use and randomly assigned to receive one of the following:     placebo disulfiram (0 mg/day), disulfiram at 62.5 mg/day, disulfiram at 125 mg/day, or     disulfiram at 250 mg/day. During induction onto LAAM, participants were administered     increasing doses of LAAM plus placebo disulfiram on a thrice-weekly basis until maintenance     doses of LAAM are attained. At the beginning of week 5, participants received LAAM plus     disulfiram or placebo disulfiram according to their randomized assignments, and were     maintained on these agents through week 16. At the end of the study, participants underwent     detoxification from LAAM and active/placebo medication over a 4- to 6-week period. All     participants received weekly 1-hour psychotherapy (Cognitive Behavioral Treatment) with     experienced clinicians specifically trained to deliver the therapy and who received ongoing     supervision. The primary outcomes were retention and reduction in opioid and cocaine use, as     assessed by self-report and confirmed by thrice-weekly urinalyses. Secondary outcomes     included reductions in other illicit drug and alcohol use, as well as improvements in     psychosocial functioning.   "
208478|NCT00580840|"     During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and     4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and     16. At Wk 18 patients will be grouped as responders or non-responders based on results of the     ACR20 at Week 16.   "
208479|NCT00580853|"     The purpose of this study is to examine how smoking cessation medications (varenicline,     bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in     non-treatment seeking daily smokers.   "
208480|NCT00580866|"     The purpose of this study is to help determine if a static stretching brace in addition to     physical therapy decreases the incidence of secondary operations, increases range of motion,     and individual patient function.   "
208481|NCT00580879|"     The purpose of this study is to see if fetal head circumference can be used as a predictor     for who will experience a sphincter laceration while delivering.   "
208482|NCT00580892|"     The researcher can use Optical coherence tomography a near-infrared diode to emit light that     can produce images of the specimen under investigation and provide information about tissue     abnormalities without causing damage.   "
208483|NCT00580905|"     The purpose of this study is to extend previous observations in animal models regarding the     effects of adenosine in the release of cytokines to human subjects. We intend to accomplish     this in two study protocols. In the first we will infuse intravenously adenosine and measure     the plasma levels of inflammatory cytokines. In the second one, we will use a microdialysis     technique to infuse intradermally small amounts of adenosine and will measure skin blood flow     and will take a biopsy to measure levels of mRNA for cytokines.   "
208486|NCT00580944|"     Port wine stain is a congenital, progressive vascular malformation of skin involving     post-capillary venules that occurs in an estimated 4 children per 1,000 live births.     Approximately 1,200,000 individuals in the United States and twenty-six million people     worldwide have Port wine stain birthmarks.      Since most of the malformations occur on the face, Port wine stain is a clinically     significant problem in the majority of patients. Port wine stain should not be considered a     cosmetic problem but a disease with potentially devastating psychological and physical     complications. Personality development is adversely influenced in virtually all patients by     the negative reaction of others to a marked person. Port wine stain are initially flat red     macules, but lesions tend to darken progressively to purple, and by middle age, often become     raised as a result of the development of vascular nodules. Hypertrophy of underlying soft     tissue further disfigures the facial features of many patients.   "
208487|NCT00580957|"     The overall goal of this proposal is to determine the role of the autonomic nervous system in     the insulin resistant state associated with obesity and the metabolic syndrome. Obesity     results from an accumulation of excessive fat deposit due to increase caloric intake or     decrease energy expenditure, this condition is usually associated with diseases such as     hypertension or diabetes, a cluster known as the metabolic syndrome. The first step in the     development of the metabolic syndrome is a resistance to the action of insulin. The mechanism     underlying insulin resistance in obesity is still unknown, however some investigators have     proposed that the autonomic nervous system, particularly the increase sympathetic activation     in obesity may play an important role. We have extensive experience studying the role of the     autonomic nervous system in the cardiovascular alterations associated with obesity by     producing complete autonomic withdrawal with a drug named trimethaphan. We propose to use the     same approach to study the role of the autonomic nervous system in the development of insulin     resistance in obesity.   "
208488|NCT00580970|"     Lovastatin may protect against late effects of radiation therapy in patients with prostate     cancer   "
208489|NCT00580983|"     The purpose of this study is to test whether the use of advanced radiation therapy delivery     techniques can spare a patient's normal tissue, including salivary glands, from radiation.     This study is being done to try to reduce radiation side effects, especially mouth dryness,     which happens with standard radiation methods. In order to reduce these side effects, other     normal tissues may receive a different radiation dose (sometimes more) than what would have     been received using standard radiation therapy. A secondary goal of this study is to     determine if the type of tumor a patient has can be controlled at least as well (or better)     using this advanced radiation therapy delivery technique as it would be if the patient was     treated with standard radiation therapy.   "
208490|NCT00580996|"     We are studying the effects of oral water ingestion in patients with orthostatic hypotension.     In this study, we are testing the null hypothesis that the blood pressure increase with oral     water ingestion will not be diminished if a full prior water dose is given a few hours     earlier.   "
208491|NCT00581009|"     This study evaluates the efficacy of sleep deprivation treatment in accelerating     antidepressant responses when administered during the first week of medications and     augmenting a sustained response with chronobiological interventions. Sleep deprivation and     chronobiological augmentation may offer a rapid and sustained antidepressant response in mood     disorder patients treated with medication, sleep deprivation, bright light therapy and sleep     phase advance compared with medication only. The chronobiological treatment is rapid,     non-invasive and has few side effects and could be of significant clinical benefit.   "
208492|NCT00581022|"     We wish to study sleep architecture in patients with chronic orthostatic intolerance. We will     test the null hypothesis that there is no difference in time during the various phases of     sleep between patients and healthy control subjects.   "
208493|NCT00581035|"     The purpose of this study is to evaluate the safety and immunogenicity of concomitant     Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of     the routine vaccination series in healthy infants   "
208494|NCT00581048|"     Asthma is a common respiratory disease of unknown etiology which currently affects     approximately 7.5 % of the adult population ( ). Asthma is an inflammatory disorder of the     airways. Airway inflammation is evident not only in patients with fatal asthma but also in     mild asthmatics ( ). Oxidant stress, defined as inadequately controlled generation of toxic     reactive oxygen species (ROS) in the cells or tissues is a common feature of inflammation,     and has also been documented in asthma ( , ). However, the current understanding of the     relationship between the inflammation and the oxidant stress in asthmatic airways is poor.     Does oxidant stress contribute to the expression of asthmatic phenotypes independently of     inflammation? If so, could asthmatics benefit from supplementation of antioxidants? These     questions have been nagging us since our laboratory provided credible evidence of oxidant     injury in the airways of allergic asthmatics ( ). The purpose of our study is to more     precisely determine 1/ the pathophysiologic role of oxidative stress, and 2/ usefulness of     antioxidant therapy using vitamin E in allergic asthma.   "
208495|NCT00581061|"     Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading     cause of death from cancer in men. Radical prostatectomy is one of the treatment options     available for organ-confined disease. Over 100,000 radical prostatectomies cases (total     removal of the cancerous prostate by surgery) are performed in the United States yearly.     Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life     (QOL) scores due in part due to a postoperative incontinence which may require the use of     multiple urinary pads per day. Many of these men also report debilitating irritative voiding     symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction     scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients     symptoms may persist for longer periods.      Our recent published findings suggest that instability in the bladder muscle is likely an     underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle' instability     results in excess contractions of the urinary bladder ('urgency to urinate'), and can result     in the feeling of needing to urinate more frequently. Consistent with this hypothesis of     detrusor muscle instability, men with postoperative dribbling had more complaints with     urgency, frequency and bother scores when queried with validated questionnaires. We suspect     that a transient bladder muscle contraction may overcome the urinary sphincter valve     resistance and result in the patient's dribbling of urine.      By treating the bladder muscle instability, we expect improved postoperative continence and     improved quality of life in patients after undergoing surgery for total removal of a     cancerous prostate. This pilot study will assess the statistical requirements for the number     of subjects needed for a fully 'powered' randomized prospective study to fully evaluate     whether medications such as solifenacin significantly improve patients' quality of urinary     life and improve postoperative urinary incontinence after surgery.   "
208496|NCT00581074|"     This trial examines the effects of grapefruit or grapefruit juice on anthropometry, dietary     intakes, appetite, and metabolic profile in overweight and obese young and middle-aged     adults.   "
208497|NCT00581087|"     DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic     hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in     human. The purpose of this study is to determine if DHEA is effective in the treatment of     respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease     (COPD) on exercise capacity and haemodynamic variables. Patients will receive after     randomization either 200 mg oral DHEA or placebo over a one-year period. Evaluation concerns     clinical parameters, echocardiography and right catheterization after and before treatment.     Primary end-point is the six-minute walk test. This is a prospective double blind,     randomized, placebo controlled study which will be realized in four university hospitals in     France : Bordeaux, Strasbourg, Toulouse and Limoges.      Eight patients with pulmonary hypertension (New York Heart Association functional class III     or IV) associated with COPD were included in a pilot study between 2004 and 2005. Inclusion     criteria were: COPD was defined by FEV1/FVC < 70% of reference values; resting mean pulmonary     artery pressure (assessment by right pulmonary catheterization) ≥ 25mmHg with mean pulmonary     capillary wedge pressure ≤ 15mmHg, PaO2 ≤ 60mmHg at rest or PaO2 ≥ 60mmHg associated with     significant fall in O2 saturation with exercise; oxygen treatment initiated more than six     months previously. Exclusion criteria were: clinical or respiratory instability during the     three months before the inclusion in the study; corticosteroids therapy (> 0.5mg/kg/day of     prednisolone or as equivalent); hepatic (prothrombin time < 50%) or renal (creatininemia >     130µmol/L) failure; diabetes; left ventricular dysfunction; PSA (prostatic antigens >     2,5ng/ml) and past history or diagnosis of cancer. The study was conducted in accordance with     the Good Clinical Practices Guidelines. The study protocol was approved by the ethics review     board of the University Hospital of Bordeaux (France). Written informed consent was obtained     for all patients and investigations were conducted according to the institutional guidelines     and to the Helsinki principles. This trial conducted enrollment between 2004 and 2005, but     had not been registered in ClinicalTrials.gov because it preceded this policy.(Study design:     The dose of oral DHEA administered was 200 mg once daily for three months. At baseline and     after three months of treatment, clinical evaluation included 6MWT, Borg dyspnea index,     systolic and diastolic blood pressure, right heart catheterisation, lung function testing and     serum DHEA levels were performed.)   "
208498|NCT00581100|"     The purpose of this study is to evaluate if Etanercept administered at a higher initial dose     provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower     initial dose.   "
208499|NCT00581113|"     For patients with 1-6 intraparenchymal brain metastases from various primary histologies     (except for melanoma), stereotactic radiosurgery (administered upfront or concurrently) or     complete surgical resection with neural stem cell (NSC)-preserving whole-brain radiotherapy     (WBRT) results in improved neurocognitive profile over standard WBRT. The goal of this study     is to assess feasibility of this treatment approach.   "
208500|NCT00581126|"     To assess efficacy and safety of BeneFix® for prophylaxis in Short-term therapy and on     demand therapy for all bleeding episodes of subjects with hemophilia B.   "
208501|NCT00581139|"     The primary hypothesis tested in this project is that the preoperative behavioral stress     response predicts postoperative behavioral and clinical recovery of children undergoing     surgery.   "
208502|NCT00581152|"     Stem cells can develop into every cell, every tissue and every organ in the human body, e.g.,     they can make any kind of cells in the human body. Stem cells reproduce themselves many times     over and over. Their almost limitless potential has made stem cells a significant focus of     medical research. But before scientists can use stem cells for medical purposes, they must     first learn how to harness their power. They cannot treat disease until they learn how to     manipulate stem cells to get them to develop into specific tissues or organs.      We know that turning genes on and off is crucial to the process differentiation, so we can     add some factor into the culture dish and observe stem cells to differentiate into specific     types of cells. But some sort of signal is needed to actually trigger the stem cells to     differentiate. We are still searching for that signal. If we can ultimately learn how to     direct stem cells to differentiate into one type of tissue or another, then we can use them     to treat patients. In this proposal, we will first examine this step.      We propose a novel approach to understanding differentiation of human embryo stem (hES)     cells, by studying TBX3, a protein called a transcription factor that controls the expression     of other genes. In humans, the loss of function of TBX3 causes Ulnar-Mammary Syndrome, a     genetic disorder that can pass from one generation to the next. Furthermore, our preliminary     results show that TBX3 is downstream mediator of another protein, BMP4. BMP4 is a known key     regulator for hES cell differentiation. Thus, TBX3 is an attractive candidate as a downstream     mediator of BMP4 in hES cell differentiation. We will test TBX3 effects on hES cell     differentiation if down-regulate TBX3 in hES cells with a technology called siRNA knockdown.     We will identify the genes controlled by TBX3 with a recently invented powerful technology     called CHIP-GLAS. This technique allows us to examine thousands of genes on a small chip in a     single experiment. We expect that the innovative experiments proposed here will open a new     avenue to understanding the signal of hES cell differentiation.   "
208503|NCT00581165|"     Evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in Spain;     (ii) the incidence of adverse events reported in these patients, and (iii) the role that age     and concomitant therapy might play in the development of adverse reactions.   "
208504|NCT00581178|"     Ureteral stent placement is one of the most common procedures performed within urology. The     stents are generally placed for relief of obstruction or to prevent obstruction following a     urological procedure. Most patients with ureteral stents will eventually form stent     encrustations. However, patients form these encrustations at dramatically different degrees     and rates ranging from no encrustation at 1 year of stenting to severe encrustation in just a     few weeks. The purpose of this study is to determine if the degree of encrustation on a stent     for any given patient can be predicted based on 24 hour urine parameters prior to stent     placement, with the stent in place and after stent removal.      Patients who will be receiving stents for other urological reasons will have a 24 hour urine     sample collected before stent placement, while the stent is in place and after the stent has     been removed. The parameters examined in the 24 hour urine collected will then be compared to     the amount of encrustation there is on the stent to see if there is any correlation between     the two.   "
208505|NCT00581191|"     Safety and tolerability of single oral doses in healthy subjects.   "
208506|NCT00581204|"     The purpose for this study is to measure the physiology of human undergoing a Lower Body     Negative Pressure usea non-invasive low-power optical technique, near-infrared diffuse     optical spectroscopy measurement and compare these measurement to standard monitoring     procedures delineated in the Brooke Army Medical Center.      The Brooke Army Medical Center can use near-infrared diffuse optical spectroscopy to provide     functional physiologic tissue and organ information without ionizing radiation and without     withdrawing any blood, in a cost-effective and rapid manner. Monitoring for the onset of     circulatory shock in a wounded soldier on the battlefield is typically performed by     measurement of arterial blood pressure, arterial oxygen saturation, or simple auscultation of     the pulse. Shock is typically recognized by non-specific signs and subjective symptoms such     as cold clammy skin, pallor, weak thready pulse, unstable vital signs, and diminished     mentation.   "
208507|NCT00581217|"     The research will be looking at patient outcomes for healing of donor sites after a     split-thickness skin graft procedure for a burn or skin tissue loss. Donor site healing time,     infection rate, cosmetic outcome, and patient's rating of pain will be compared between two     donor site dressings, Glucan II and Aquacel Ag.   "
208509|NCT00581243|"     Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and     schizoaffective disorder to assess safety and tolerability.   "
208510|NCT00581256|"     Radiotherapy has been shown to reduce breast-cancer specific mortality in patients at high     risk for distant dissemination. It has also been shown to increase rates of non-breast cancer     deaths and morbidity due to cardiovascular and pulmonary toxicity. Although treatment     planning has improved significantly through the years, recent reports still demonstrate     treatment-related morbidity even with 3-dimensional planned techniques. Thus, while 3D     planning represents the state of the art treatment for loco-regional radiotherapy for breast     cancer, further improvement is needed to continue to decrease heart and lung exposure. The     ultimate goal of the proposed research is to determine whether treatment planning using     intensity-modulated radiotherapy (IMRT), the next generation of radiation treatment     delivery systems, results in less radiation exposure to the heart and lungs than the best     current RT technique in women with node positive breast cancer. This proposal will test the     potential clinical value of IMRT compared to the best standard 3D plan (partially wide     tangent fields, PWTF) in the treatment of breast cancer. These two treatment techniques will     be studied in a Phase II randomized trial using quantitative indicators of potential cardiac     and lung toxicity. The preliminary data generated from this trial will be used to ultimately     justify a multi-institutional comparison of the two treatment techniques with long-term     clinical cardiac and pulmonary toxicity as endpoints.   "
208511|NCT00581269|"     The oxidative stress and inflammatory state is known to contribute to the pathogenesis of     atherosclerosis, and is predictive of cardiovascular events and mortality rates in the     general population and patients with chronic kidney disease (CKD), particularly in patients     with end stage renal disease (ESRD) on dialysis therapy 1. Increased oxidative stress and     inflammation has been identified in all stages of CKD, ranging from moderate renal     insufficiency to ESRD. However, the pathophysiology of increased oxidative stress and     inflammation associated with the development of CKD is currently poorly understood.      There is also concern about the epidemic of obesity in the United States, as the overall     health status of the general population is adversely affected by increasing adiposity. Recent     studies indicate a strong relationship between adiposity and incident CKD. Furthermore, the     presence of an elevated body mass index (BMI) is an independent predictor for progression to     ESRD, even after additional adjustments for baseline blood pressure and the presence or     absence of diabetes mellitus. Limited data in the general population show that healthy     lifestyle interventions, such as exercise and dietary caloric restriction, either alone or in     combination, reduce the inflammatory and oxidative stress burden seen in obese subjects. The     impact of healthy lifestyle modifications on inflammation and oxidative stress has not been     investigated in the obese CKD population. Based on the foregoing observations, the purpose of     this investigation will be to determine whether healthy lifestyle interventions in the form     of low-impact aerobic exercise and dietary calorie restriction in obese subjects (BMI ≥     30kg/m2) with moderate to severe (Stage III-IV) CKD [estimated glomerular filtration rate     (GFR) 20-59 ml/min] will improve oxidative stress, inflammation, insulin resistance,     adipocytokines, endothelial dysfunction, and quality of life.   "
208512|NCT00581282|"     This study evaluates theories regarding cocaine abstinence which propose that increased     presynaptic and postsynaptic dopamine activity and increased serotonin activity are     associated with abstinence in cocaine dependent subjects at the beginning and three to six     months after a treatment program. We are using positron emission tomography (PET), Magnetic     Resonance Imaging (MRI) and diffusion tensor imaging (DTI) in cortical and subcortical areas     in a series of brain imaging studies testing these theories of abnormalities in the dopamine     and serotonin system for cocaine addiction by examining the distribution of 18F-fallypride,     18F-altanserin, and FDG. We are evaluating genetic theories associated with cocaine addiction     through the examination of genetic markers and functional genomics.   "
208513|NCT00581295|"     Trauma remains the leading cause of death and disability for Americans age 1-44. Trauma can     cause internal bleeding, and this bleeding is often hard to detect without sophisticate tests     that take time to complete and analyze.      In addition, internal bleeding, including bleeding into the lung and chest cavity, as well as     other blood loss, happens in many critically ill patients. For example, for hemorrhage, it is     very difficult to detect active hemorrhage and to determine optimal rates of fluid and blood     resuscitation.      Diffuse optical spectroscopy has the potential to accurately assess adequacy of tissue     perfusion, oxygenation, tissue oxygen extraction, and cytochrome oxidation states that may be     critical to optimal treatment, end- organ preservation, and survival.   "
208514|NCT00581308|"     The purpose of this study is to evaluate the long-term safety and efficacy of the GORE®     HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).   "
208515|NCT00581321|"     In this study the investigators propose to assess the hemodynamic response to the ingestion     of 16 fl oz of water. The investigators will test the hypothesis that water ingestion will     increase the systemic vascular resistance.   "
208516|NCT00581334|"     Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical     prolapse repair of the vagina.   "
208517|NCT00581347|"     This study will examine whether the implementation of an outreach program that employs a     tracking/reminder/recall/home visiting strategy will have any impact on receipt of     immunizations and preventive care among urban adolescents.   "
208518|NCT00581360|"     This is a Phase II trial non-randomized study to evaluate the objective response rate and     stable disease rate (primary endpoints), progression-free survival, overall survival and     toxicities with the combination of doxorubicin and bortezomib in patients with incurable head     and neck adenoid cystic carcinoma. Also, we plan to collect tumor tissue from previous     diagnostic procedures and baseline blood specimens for future correlative studies.   "
208519|NCT00581373|"     We will test the null hypothesis that there is no diurnal (morning to afternoon)variability     in the blood pressure response to the ingestion of water 16 oz.   "
208520|NCT00581386|"     The purpose of this study is to evaluate a new supra-glottic airway device, the Disposable     Laryngeal Tube Suction (LTS-D; King Systems, Noblesville, IN). We propose to test its ease     of insertion, position within the airway, patency of drain tube and anatomic sealing     properties during spontaneous ventilation in anesthetized patients. The study device will be     compared to the ProSeal Laryngeal Mask Airway (PLMA, LMA North America Inc.) and the     Esophageal Tracheal Combitube (ETC; Tyco Healthcare/Mallinckrodt Nellcor, Pleasanton, Calif).   "
208536|NCT00571948|"     The objective of this study is to determine the influence of an increase of meat in     complementary food on iron status and the effect of an exchange of vegetable oil in the same     food on the status of omega-3 fatty acids in infants in the second six months of life.   "
208537|NCT00571961|"     The main purpose of this protocol is to study the effect of an HIV medication, Kaletra     (lopinavir/ritonavir), on buprenorphine in non-HIV infected people who have been receiving     the same dose of buprenorphine for at least 3 weeks.      Study Hypothesis:      Kaletra (lopinavir/ritonavir) will increase buprenorphine plasma levels without any     significant clinical effect on the subject or need for dose adjustment.   "
208521|NCT00581399|"     The purpose of this study is to compare a new high vacuum pressure chest drainage system     (NO-NUMO™) with the standard low vacuum pressure drainage system already in use in cardiac     surgeries. The new system uses smaller diameter drainage tubing to remove blood from the     chest after open heart surgery. This is less painful to the patient and should help the     patient to breathe better after operation. Preliminary data suggests that the high vacuum     suction is effective and practical, and could actually reduce the amount of chest tube     bleeding after surgery without compromising heart function. This new high vacuum drainage     system was approved by the FDA in 2002. Subsequent testing at University of California,     Irvine indicated that this unique system may allow the surgeon to predict excessive     postoperative bleeding before the patient is transferred out of the operating room, thus     adding safety, convenience, and cost effectiveness to their use.   "
208522|NCT00581412|"     This study is to determine whether the use of a composite biologic/synthetic graft during     abdominal sacrocolpopexy leads to a lower rate of erosion while maintaining durability.   "
208523|NCT00581425|"     A trial to see if BCC excluding the scalp and face can be treated successfully with a     combination therapy of Intron-A and Aldara.   "
208524|NCT00581438|"     Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual     clinical practice conditions in Spain.   "
208525|NCT00581451|"     Safety and tolerability study in healthy volunteers   "
208526|NCT00581464|"     80 nicotine dependent adults ages 18-65 who desire to quit smoking will be screened and, if     eligible, enrolled and randomized to one of two four-week treatments for smoking cessation.     The treatments are standard behavioral therapy and Mindfulness Based Addiction Therapy     (MBAT), which is standard therapy plus mindfulness. Standard therapy and MBAT incorporate     elements of widely-used tools for smoking cessation including managing craving and strong     emotions, problem solving, tips on healthy eating and keeping active, and exercises based on     cognitive and behavioral therapy. MBAT uniquely incorporates mindfulness practice (a     relaxation therapy) into standard therapy. Participants complete questionnaires and undergo     an fMRI scan at baseline and at the end of therapy (after they complete the 4 weeks of     standard therapy or MBAT). During each scan, participants will complete a validated     smoking-related cue paradigm and a validated affect labeling paradigm.   "
208527|NCT00581477|"     The purpose of this study is to try different medications in patients with low blood pressure     and other problems with their involuntary (autonomic) nervous system. The pharmacological     trials in this study will perhaps lead to more effective treatment. This study consists of     single dose trials, dose selection trials, 5-day trials and chronic (approximately 2 months)     trials.   "
208528|NCT00581490|"     Children with premature pubarche will have radiological and radial artery tonometry evidence     of cardiovascular morbidity at diagnosis when compared to matched controls.   "
208529|NCT00581503|"     This study has been designed to utilize already obtained biopsy specimens for investigation     of the utility of a new, non-invasive optical diagnostic technique. The study will allow a     careful correlation between the Optical coherence tomography findings and conventional     histology.   "
208530|NCT00581516|"     Prostate cancer is the second leading cause of cancer related deaths among men in the United     States.1 Although still controversial, there is growing evidence that early detection will     reduce prostate cancer mortality. Currently the most useful biomarker to aid in early     detection is measurement of serum prostate specific antigen (PSA) levels. Despite the value     of PSA it has substantial limitations. To overcome the limitations of total PSA testing,     there is emerging evidence demonstrating that relevant cancer biomarker can be detected in     urine.      Patients who present to the urology clinic for a radical prostatectomy will be asked to enter     this study. After obtaining informed consent, the following exam and specimen collection     scheduled will be followed:      Visit 1 (pre-op):      Digital Rectal Exam (DRE) - Voided urine collection & serum collection      Visit 2 (time of prostatectomy):      Under anesthesia- catheterized urine collection and serum collection      Visit 3 (approximately 8 days post-prostatectomy):      Catheterized urine collection      Visit 4 (approximately 3 months post-prostatectomy):      Voided urine collection and serum collection      Some patients will not have the serum collection at visits 1, 2, and 4. The patients will be     notified as to whether or not their blood will be drawn during the visits. Pre-operative     Digital Rectal Exam, urinary catheterization and blood draws are part of standard of care in     this patient population with localized prostate cancer. The catheter will be inserted during     the time of surgery preparation in the operating room and removed during the post operative     clinic appointment.   "
208531|NCT00571883|"     RATIONALE: Surgery may be an effective treatment for oral cancer. It is not yet known whether     surgery to remove the tumor and lymph nodes in the neck is more effective than surgery to     remove the tumor alone in treating patients with early-stage oral cancer.      PURPOSE: This randomized clinical trial is comparing two types of neck surgery to see how     well they work in treating patients with early stage oral cancer.   "
208532|NCT00571896|"     We are doing this study to see if using an over the counter mild laxative, SennaS, there is a     difference in time required to have a bowel movement in women who are having surgery for     prolapse (when your uterus and/or vagina drop after childbirth or with age) and/or     incontinence (when you leak urine or stool without your control) as compared to a sugar pill     or placebo.   "
208533|NCT00571909|"     We will enroll 20 patients to evaluate the effectiveness of a new operation known as     videothoracoscopic splanchnicectomy (VSPL) for management of chronic kidney pain. This study     is being done to test if this procedure is effective in controlling chronic kidney pain.   "
208534|NCT00571922|"     This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus     placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine     dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36     enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period,     and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine     positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period.     Secondary measures include treatment retention, drug craving, mood, and safety.   "
208535|NCT00571935|"     This trial is conducted in Europe.      The aim of this trial is to investigate the efficacy of insulin aspart compared to soluble     human insulin on blood glucose control in children below 7 years of age with type 1 diabetes.   "
208539|NCT00571987|"     In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This     combination method will provide for excision of the cancer as routinely accomplished and     ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing     large volumes of tissue. This combined open technique will allow for full histologic analysis     of the primary tumor and margin. Because no extra tissue is removed from the breast to     generate negative margins it will result in better cosmesis than re-excision to obtain     negative margins.   "
208540|NCT00572000|"     The purpose of this study is to assess the occurrence of serious adverse events (SAEs) as     well as evaluate the occurrence of solicited local and solicited general symptoms and the     occurrence of medically significant conditions reported throughout the study period.   "
208541|NCT00572013|"     To determine the response rate, complete and partial, of patients with indolent lymphoma     receiving Rituxan and BEAM with autologous stem cell transplant.   "
208542|NCT00572026|"     Among children, attention-deficit/hyperactivity disorder (ADHD) is associated with an     increased risk for accidents, especially bicycle and pedestrian (Leibson 2001; Jensen 1988;     DiScala 1998). Anywhere from 40% to 80% of children diagnosed with ADHD continue to display     symptoms of the disorder into adolescence(Barkley 1990; Gittelman 1985). Adolescents with     ADHD are also at an increased risk for driving-related accidents, being 2 to 4 times more     likely to experience a motor vehicle accident (Barkley 1993; Barkley 1996; Cox 2000), 4 times     as likely to be at fault in the accident (Barkley 1993), and over 3 times more likely to     incur associated injuries as a result of the accident(Murphy 1996).      Stimulant treatment with immediate-release methylphenidate (IR MPH) has been demonstrated to     improve driving performance in adolescents with ADHD.      Hypothesis to be Tested:        -  Main study: Just as stimulant medication improves simulation and on-road driving          performance of ADHD teenagers, it is hypothesized that stimulant medication will improve          routine driving performance.        -  Substudy - Extended wear (15 hours) of Daytrana will lead to safer driving late in the          evening (22:00 and 01:00), when the most dangerous driving mishaps are most likely to          occur, and the next morning at 09:00.   "
208543|NCT00572039|"     This randomized, controlled clinical trial will test the efficacy of Problem-Solving     Treatment (PST) to improve vision function in older persons with age-related macular     degeneration (AMD). AMD is a highly prevalent, disabling disease of aging that causes severe     vision loss and functional decline. It is the leading cause of blindness in older persons in     the United States and may affect more than 10 million people. Currently, there are no     effective treatments to restore vision. Thus, improving Vision Function is a major goal of     treatment. Vision function refers to vision-related abilities to perform daily living     activities (e.g. reading recipes to prepare meals). Decrements in vision function will become     a major public health problem as the population ages and the prevalence of AMD increases. PST     is a brief, standardized, cognitive-behavioral treatment that teaches problem-solving skills.      We believe PST will enable patients with AMD find practical solutions to vision-related     problems and thereby improve vision function.      We will recruit 240 AMD patients from the retina clinics of Wills Eye Institute,     Philadelphia, PA, with bilateral AMD and visual acuity worse than 20/70 in the better eye.     PST-trained therapists will deliver 6 1-hour, in-home sessions to the 120 subjects randomized     to PST. The control treatment is Supportive Therapy (ST), a similarly structured,     standardized psychological treatment that controls for the non-specific effects of treatment     (n=120). ST contains no active elements beyond its non-specific components; in this way it is     a placebo treatment. Independent raters, masked to treatment assignment, will assess Targeted     Vision Function (primary outcome) and vision-related quality of life (secondary outcome) at 3     months to assess PST's efficacy, and at 6 months to evaluate its long-term effects. As the     population ages, the disability of AMD will become more prevalent, costly, and burdensome to     patients, families, and ophthalmologists. This makes devising and testing practical and     affordable interventions to improve vision function a national priority.   "
208544|NCT00572052|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     investigate if a 31 gauge x 6 mm needle will provide comparable blood glucose control to the     29 gauge x 12.7 mm needle in obese subjects with diabetes.   "
208545|NCT00572065|"     This is an open-label, one arm, single institution study. Arsenic trioxide [TrisenoxTM     Injection], 0.25mg/kg/dose administered intravenously over 2 hours.      20 patients      Complete remission, partial remission, clinical improvement, progressive disease, stable     disease, relapse (per IWG consensus criteria, 2006) Clinical chemistry, hematology and ECGs     will be assessed at least weekly during study treatments. Adverse events will be assessed in     accordance with the NCI Common Toxicity Criteria, Version 2 at each study visit.   "
208546|NCT00572078|"     The purpose of this study is to evaluate the safety and tolerability and describe the maximum     tolerated dose (MTD) of treatment with escalating doses of sorafenib in combination with     bevacizumab and paclitaxel for patients with advanced solid tumors.   "
208547|NCT00572091|"     Improvement in heart failure with moderate to severe mitral regurgitation using a     percutaneously delivered implanted device   "
208548|NCT00572104|"     This study will compare the ability of two types of long term (12 months) weight-bearing     exercise treatments (1. high-intensity jumping and 2. weight lifting) to increase bone mass     of the total body, spine and hip in physically active men with osteopenia.   "
208549|NCT00572117|"     The purpose of this study is determine whether the use of topiramate is effective in the     treatment of alcohol dependence (i.e. decreases drinking) in patients with bipolar disorder.   "
208550|NCT00572130|"     Rexin-G is a tumor-targeted gene medicine that is designed to seek out and destroy both     primary tumors and metastatic cancers without the side effects of standard chemotherapy. The     objectives of the study are: (1) to evaluate the clinical effectiveness of intravenous     injections of Rexin-G, a tumor-targeted gene vector, in controlling tumor growth and     prolonging life, and (2) to evaluate its over-all safety.   "
208551|NCT00572143|"     The purpose of this study is to clarify cost effectiveness and quality of life issues among     colon cancer patients followed up in a hospital setting or by their GP`s.Statement of study     hypothesis:Postoperative follow up of colon cancer patients (according to national     guidelines) by general practitioners will not have any influence on patients' quality of     life. There will not be observed any increase in serious clinical events and cost     effectiveness will be improved.   "
208564|NCT00572325|"     Our group has shown in a modeling study that increasing the radiation dose to pre-specified     normal tissue dose constrains could lead to increased TCP with the same NTCP in patients with     non-concurrent chemo-radiation. In a subsequent phase I trial, in patients receiving     non-concurrent chemo-radiation we showed the safety of this approach. Here,we want to     investigate its efficacy in a prospective study in patients with stage III NSCLC, who are     selected for radical concurrent radiotherapy   "
216940|NCT00690703|"     The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective     treatment for malignant lung tumors.   "
208552|NCT00572156|"     IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in     response to another hormone called growth hormone. Growth Hormone is produced by a small     gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors     to growth during infancy, childhood, and adolescence.      Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone     and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but     IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a     type of growth hormone insensitivity and an inability to grow normally.      This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will     help children with IGFD grow taller more quickly than children treated with rhGH alone. The     study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration     (FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH     in children with IGF-1 deficiency (IGFD) is investigational.   "
208553|NCT00572169|"     With this study - Total Therapy IIIB - researchers are extending the findings of Total     Therapy III based what they have learned from the first two studies (Total Therapy I and II),     with new research strategies designed to explore why chromosome abnormalities found in     persons with multiple myeloma affect the outcome of drug therapy used in this disease.   "
208554|NCT00572182|"     RATIONALE: MK0752 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of MK0752 in treating     young patients with recurrent or refractory CNS cancer.   "
208555|NCT00572195|"     The RNS® System LTT study is designed to assess the ongoing safety and to evaluate the     long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of     seizures in individuals 18 years of age or older with partial onset seizures that are     refractory to two or more antiepileptic medications. Candidates will continue to receive     their epilepsy medications while participating in the trial.   "
208556|NCT00572208|"     In this study we will focus on the postoperative recovery. A successful postoperative     recovery should bring the patient to at least to the pre-surgical level. This can probably be     achieved by a multimodal approach where at least postoperative pain and PONV are managed.      The surgical injury results in immobilisation which again can result in impaired cardiac,     respiratory and musculoskeletal system. Pain relief is a prerequisite for mobilisation and an     early return to the pre-surgical level. The preferred drugs for postoperative pain management     are opioids. Although opioids are known to be an effective analgesia, they have a series of     side effects: nausea, vomiting, constipation, respiratory deficiency, delirium among others.      Gabapentin has been tested for post operative pain. Randomized Clinical Trials have reported     a significant better pain scores with Gabapentin in several studies -most of them restricted     to the postoperative period in the post-anaesthesia care unit in many different kind of     surgeries.      We want to test if Gabapentin can be used instead of opioids for treatment of postoperative     pain after heart surgery by median sternotomy.   "
208557|NCT00572221|"     The overall goal of this project is to increase the number of high quality nursing homes in     Massachusetts. The study will evaluate an intervention involving two active treatment arms:     one implementing a CQI program and a second implementing the CQI program and specific     protocol programming. The intervention will be implemented in 24 nursing homes identified as     performing, over multiple quality indicator domains, at a poor or average level across     multiple outcome domains.   "
208558|NCT00572234|"     Methamphetamine dependence is a significant drug use disorder in the Midwest. While a number     of psychosocial and pharmacological treatments have been studied, no specific treatments for     methamphetamine have been identified. This study is a collaborative pre-clinical and clinical     partnership examining bupropion in the treatment of methamphetamine dependence.   "
208559|NCT00572247|"     The primary aim of the project is to examine the efficacy of the Psychiatric Rehabilitation     Weight Loss program in reduction of weight and body mass index (BMI.   "
208560|NCT00572260|"     The goals of the study are to evaluate the feasibility of using daptomycin as a prophylactic     antimicrobial agent in patients undergoing cardiac surgery, to determine the rates of     surgical site infection, and to evaluate the occurrence of adverse events.   "
208561|NCT00572286|"     The purpose of this research study is to apply new non-invasive, no-risk techniques to a     cardiac transplant population for assessment of their reliability in detecting heart     transplant rejection.      Graft rejection remains a major factor limiting long-term survival despite continued     advancement in the use of immunosuppression. Aggressive surveillance for the detection of     acute rejection is therefore necessary. Repeated endomyocardial biopsy (EMB) (at least 11     times the first year after transplantation) remains the only reliable surveillance method     available. EMB is expensive, invasive, inconvenient to the patient, and associated with a     significant incidence of serious complications. Therefore, it would be very important for     patient care if new no-risk methods would prove to be effective in surveillance of rejection.      This research study is designed to measure non-invasive ways to assess rejection along with     the standard planned endomyocardial biopsies you will have after heart transplantation.     First, the investigators plan to test the effectiveness of the investigational use of the CMI     2406 Magnetocardiograph that has been approved by the U.S Food and Drug Administration (FDA).     While the device used in the study is FDA-approved for the non-invasive measurements and     recordings of the heart's magnetic field reflecting the heart's electrical currents, it is     not yet approved for the specific use of detection of transplant rejection.   "
208562|NCT00572299|"     The purpose of this study is to determine the difference in response to bisphosphonate     therapy in patients receiving excess glucocorticoids compared to patients with postmenopausal     or male osteoporosis. Bisphosphonates are approved by the FDA for the treatment of     postmenopausal women and osteoporotic men who are at high risk of fracture and in men and     women with excess glucocorticoid administration.   "
208563|NCT00572312|"     The main purpose of the study is find whether the addition of statin (Atorvastatin) to dual     renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme     inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria,     main prognostic marker of chronic kidney disease progression.   "
208833|NCT00584896|"     The purpose of this study is to determine if the use of PB127 with cardiac ultrasound assists     in the diagnosis or exclusion of coronary artery disease.   "
208566|NCT00572351|"     Healthy pre-menopausal women will be recruited in order to test the effects of red wine and     white wine on blood estrogen and progesterone levels. The women will be randomized and     rotated through two different treatments (red wine, white wine). Estrone and estradiol are     hormones in the category of estrogens. It is known that the bodies of both men and women may     convert (or aromatize) a certain amount of naturally occurring testosterone into estrogen.     Aromatase inhibitors have been used to prevent this conversion, or aromatization, of     testosterone into estrogen, in the treatment of estrogen-dependent breast cancer in women.     This inhibition leads to a marked decrease in estrogen (estradiol and estrone) levels.     Naturally occurring aromatase inhibitors include grapes, grape juice, and red, but not white     wine. The aromatase inhibitory effects are attributed to wine phytochemicals and not to     alcohol. Based upon this information, the investigators will monitor the estrogen levels at     various phases in the menstrual cycles of women since hormone levels naturally vary     throughout the menstrual cycle. Several epidemiologic studies have found that there is a     correlation with moderate to high levels of alcohol consumption and breast cancer. Therefore,     study participants will be asked to drink only a eight ounces of wine which should have     minimal or no risk for the development of breast cancer.   "
208567|NCT00572364|"     The purpose of the study is to assess the safety and tolerability of AZD2281 following single     and multiple oral doses in patients in Japan with advanced solid malignancies   "
208568|NCT00572377|"     Female sexual arousal disorder (FSAD) is a frequent finding in women in middle age and more     prevalent in post-menopausal women. Topical alprostadil is currently under development for     the treatment of FSAD. The purpose of this research is to determine if this formula of     alprostadil is safe and effective in women with FSAD. We will be comparing alprostadil to     placebo. Each participant will be treated for 1 month with active alprostadil and 1 month     with placebo without knowing which they are using. This way, the investigators can compare     the effects of alprostadil to the effects of an inactive topical gel.      Post-menopausal women with FSAD will be recruited. The women interested in participating in     the study will first meet with investigators and answer questions to make sure they are     eligible for the study and fit the diagnosis of FSAD.      Once enrolled, subjects will fill out questionnaires about their medical history, social     history, and psychosocial history. They will also undergo medical examination. At this     introductory research visit they will fill out baseline questionnaires, give medical history,     undergo physical exam and have blood drawn. The informed consent will be reviewed and will be     signed by the participant at this time.      The subject will then return for the 1st treatment visit at which time vital signs like blood     pressure and heart rate will be taken, external genitalia will be examined and study drug     will be dispensed after randomly being assigned to either alprostadil or placebo. After     instruction, the subject will use first dose in the clinic and be monitored for 2 hours     looking for changes in vital signs or local genitalia reaction. If no problems are noted,     subject will be sent home with study drug and Female Sexual Encounter Profile Cards (FSEP).     The patient will fill out these cards with each sexual encounter. After 1 week patient will     be contacted by phone and asked about side effects or concerns. After 4 weeks the subject     will return for another study visit at which time FSEP cards and left over study drug will be     collected, questionnaires will be filled out, labs will be drawn and subject will undergo     exam of external genitalia. The subject will then be sent home for a 2 week washout period.      The subject will return after this 2 week period with no study medication; she will then     return and the above process will be repeated with either alprostadil or placebo (whichever     she did not receive the first time).   "
208569|NCT00572390|"     By exploring hormonal status in hypopituitary women during oestrogen treatment and without     estrogen substitution the influence on sexhormones and organ function is estimated.   "
208570|NCT00572403|"     This research project will look at the relationship between baseline variables, and the new     onset of microalbuminuria and the response to treatment with an angiotensin receptor blocker,     losartan, in a cohort of 246 early hypertensives and normotensives who are being brought back     for a 4-5 year follow up visit as part of a continuing project. We hypothesize that the new     onset of microalbuminuria is associated with higher blood pressure levels at baseline and 1     year as well as being associated with elevated left ventricular mass index. The rate of new     onset microalbuminuria in non-diabetics is not established and this prospective study will     provide data.   "
208571|NCT00572416|"     1. This randomized clinical trial compares a four component behavioral sleep intervention          group to an attention control healthy eating group        2. The behavioral sleep intervention is designed to reduce fatigue in women with stages          I-IIIA breast cancer receiving anthracycline-based chemotherapy        3. The intervention uses an Individual Sleep Promotion Plan to promote daytime activity and          nighttime sleep,and to decrease physchological and symptom distress        4. The healthy eating group receives equal time and attention and information on healthy          eating        5. All participants receive a research nurse visit 2 days prior to each chemotherapy          treatment, and 30, 60, 90 days after the last treatment, and one-year after the first          treatment.        6. Adherence to the intervention is calculated at each time        7. Reliable and valid instruments are used, including wrist actigraphy   "
208572|NCT00572429|"     HIV patients treated with Highly Active AntiRetroviral Therapy (HAART) show significant     metabolic symptoms, such as lipodystrophy, dyslipidemia, and insulin resistance. A possible     contribution to these symptoms in HIV/HAART is a decrease in mitochondrial function,     resulting in a decreased fatty acid oxidation. A combined regime of aerobic and resistance     training has been demonstrated to increase lean body mass and reduce overall fat and truncal     fat and the levels of triglyceride and LDL cholesterol.   "
208573|NCT00572442|"     The purpose of this research study is to perform serial magnetocardiographs (MCG)and     cardiovascular risk factor assessments on individuals with no symptoms or history of heart     disease. This small sized study of MCG in healthy individuals will allow for data collection     for power analysis for a larger prospective trial.      Volunteers are not compensated or paid.   "
208574|NCT00572455|"     To evaluate the safety and efficacy of PF-04217329.   "
208575|NCT00572468|"     This is a randomized trial comparing the effect of oral simvastatin versus placebo on targets     of the mevalonate pathway in men undergoing a prostatectomy as planned management for     prostate cancer. Observed tissue effects will be correlated with changes in serum cholesterol     and low-density lipoprotein.   "
208593|NCT00572728|"     This phase II trial studies how well 3'-deoxy-3'-18F fluorothymidine (18F-FLT) positron     emission tomography (PET)/computed tomography (CT) works in predicting response in patients     receiving chemotherapy and undergoing surgery for breast cancer that has spread from where it     started to nearby tissue or lymph nodes. Diagnostic procedures, such as 18F-FLT PET/CT, may     help in learning how well chemotherapy works to kill breast cancer cells before surgery and     help doctors plan the best treatment.   "
208595|NCT00572754|"     The objective of this clinical investigation is to provide the first and preliminary clinical     data to study the safety and efficacy of male circumcision where the dry circumcision method     is employed.   "
209076|NCT00587184|"     This data review will be done to evaluate the use of confocal microscopy imaging in patients     who were seen for clinically indicated endoscopic surveillance and biopsies of Barretts     Esophagus   "
208577|NCT00572494|"     Prospective, multicenter, randomized clinical trial, Follow-up at 1-, 6- and 12 months      This clinical investigation is first of all designed to demonstrate the safety and     effectiveness of the MAGIC EXPLORER stent system. The primary objectives of the study are to     evaluate the safety and 6-month patency of the bioabsorbable MAGIC EXPLORER stent in patients     with stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries. Secondary     endpoints are the procedural success, patency at all follow-ups, late lumen loss and     limb-salvage rate. Peri-procedural complications (within 24 hours) will be evaluated.     Furthermore, data of the balloon catheter PLEON EXPLORER will be collected to demonstrate its     effectiveness and safety.   "
208578|NCT00572507|"     MonoMax will be used for a continuous all-layer (except skin) suture to close abdominal wall     after midline incision. The primary objective of this trial is to demonstrate that the     frequency of wound infection and the frequency of reoperation due to burst-abdomen after     primary median laparotomy for elective surgical intervention are equal or lower than in the     INSECT trial. The secondary objectives are to demonstrate that the length of postoperative     hospital stay and the frequency of abdominal hernias 12 months after the surgery are equal or     lower than in the INSECT trial. [Knaebel HP et al., 2005]   "
208579|NCT00572520|"     This study will compare the effectiveness of two weight loss programs, one supplemented with     health education and the other supplemented with behavioral counseling, in treating women who     are depressed and overweight.   "
208580|NCT00572533|"     First clinical evaluation of Smart Anemia Manager algorithm.   "
208581|NCT00572559|"     Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care     patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus     (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals.     Ineffective treatment of MRSA VAP clearly leads to prolonged mechanical ventilation and is     probably associated with higher mortality. The purpose of this protocol is to directly     compare linezolid and vancomycin specifically for MRSA VAP.   "
208582|NCT00572572|"     Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly     emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied     in multiple-day chemotherapy treatment programs. This study will compare the addition of     aprepitant compared to placebo administered on days 3,4,5 of chemotherapy administration for     acute CINV prophylaxis with standard antiemetic prophylaxis and days 6 and 7 for delayed CINV     prophylaxis in a double-blind, randomized, crossover study design.   "
208583|NCT00572585|"     This study will evaluate the efficacy, safety and tolerability of AEB071 in the treatment of     active, moderate to severe ulcerative colitis in patients who have failed conventional     therapy using mesalamine or steroids   "
208584|NCT00572598|"     Multidrug resistance (MDR) is a cause of treatment failure in many cancer patients. MDR     refers to a phenotype whereby a tumor is resistant to a large number of natural     chemotherapeutic drugs. Having prior knowledge of the presence of such resistance would     decrease morbidity from unsuccessful therapy and allow for the selection of individuals who     may benefit from co-administration of MDR inhibiting drugs. The Tc-99m labeled single photon     emitting radiotracers sestamibi and tetrofosmin have shown some predictive value. However,     positron-emitting (PET) radiotracers, which allow for dynamic, quantitative imaging, hold the     promise of more accurate and specific identification of MDR tumors.      Objective:      To obtain human safety data, to demonstrate imaging feasibility with FPAC, to obtain human     biodistribution and to obtain preliminary evidence of breast tumor uptake concordance with     response to therapy.   "
208585|NCT00572611|"     The primary objective of the study is to define the absorption and excretion kinetics of     bilastine in man following oral administration, and to investigate the nature of the     metabolites present in plasma and excreta. The secondary objective of the study is to assess     the safety and tolerability of bilastine   "
208586|NCT00572624|"     Obesity adversely affects myocardial (muscular heart tissue) metabolism, efficiency, and     diastolic function. The objective of this study was to determine if weight loss could improve     obesity-related myocardial metabolism and efficiency and if these improvements were directly     related to improved diastolic function.   "
208587|NCT00572637|"     This Phase 1 escalating-dose study is designed to assess, the safety, tolerability,     pharmacokinetics, and pharmacodynamics of the novel proteasome inhibitor CEP 18770, given     intravenously as single agent, in patients with advanced, incurable solid tumours or NHL, and     to identify the recommended dose of CEP 18770 to be used in Phase 2 studies.   "
208588|NCT00572650|"     This study will evaluate the pharmacokinetics of vildagliptin (LAF237) and its metabolites in     patients with mild renal impairment compared to their sex, age and weigh based healthy     volunteer counterparts.   "
208589|NCT00572663|"     The main purpose of the study is find whether the addition of N-acetylcysteine (antioxidant)     to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme     inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria,     main prognostic marker of chronic kidney disease progression.   "
208590|NCT00572689|"     This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar     in non-pregnant patients with type II diabetes, works in pregnant women. To do this, we will     study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly     your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the     body; specifically, how effectively exenatide helps your pancreas secrete insulin and how     well it controls blood sugar after a meal). There are only two main drug therapies (insulin     injections and glyburide pills) currently used for gestational diabetes and not all women     achieve good enough blood sugar control without side effects. Therefore, we hope to find out     if exenatide might also be helpful in gestational diabetes.   "
208591|NCT00572702|"     Head to Head comparison of perioperative complications and secondary the impact of operation     techniques with or without mesh on patients suffering from pelvic organ prolapse on quality     of life.   "
208592|NCT00572715|"     Our first aim is to describe how common a sudden decrease in renal function happens in     infants in a neonatal intensive care unit. We also want to see how a sudden loss of renal     function affects survival. Finally, we will explore non-invasive markers to identify a sudden     decrease in renal function from urinary samples.   "
208596|NCT00572767|"     The aim of the study is to evaluate the effect of Dextro-amphetamin added to physiotherapy on     motor recovery in patients after stroke. The study is a double-blinded placebo-controlled     randomised controlled trial.      Patients after a first-ever ischemic stroke will receive Dexamphetamine (10mg) twice per week     for a duration of five weeks after a baseline phase of two weeks.      The outcome measure focuses on motor recovery and will be assessed:        -  one and two weeks before study intervention (baseline phase)        -  five times during the study intervention        -  one week after study intervention (follow-up)        -  once after six and twelve months after start of the study intervention (follow-up).   "
208597|NCT00572780|"     Specific CT Enteroclysis findings with or without other clinical and laboratory variables,     can identify Crohn's disease patients who will response to medical therapy versus those who     will either fail and require surgery or have uncontrolled disease.   "
208598|NCT00572793|"     The purpose of this study is to evaluate whether it is possible to detect changes in the     concentration of PP13 in the blood of pregnant women who may go on to develop the     complication of preeclampsia later on in the pregnancy, and if these changes can be detected     early enough to allow early diagnosis and treatment for prevention of these complications and     reduce their damage. This study will test if the PP13 biomarker during the first trimester of     pregnancy has the ability to provide assessment of risk for the development of preeclampsia     that necessitates delivery before 37 weeks gestation or can predict preeclampsia before 34     weeks gestation.   "
208599|NCT00572806|"     This trial is conducted in Europe. The aim of this trial is to investigate if using insulin     aspart as start therapy will improve the efficacy on daytime blood glucose cycle profile in     subjects with type 2 diabetes.   "
208600|NCT00572819|"     The aim of this study is to investigate whether 1000 micrograms of self-administered vaginal     misoprostol 12 hours before operative hysteroscopy results in effective preoperative cervical     ripening after two weeks pretreatment with 25 micrograms daily vaginal estradiol, compared to     placebo (lactosum monohydricum) in postmenopausal women.   "
208601|NCT00572832|"     This is a randomized, open label trial of HPV (human papilloma virus) vaccine, comparing an     on-time administration of the third dose with delayed administration of the third dose. All     participants would receive the first and second doses according to schedule. They would be     randomized to either vaccine at 6 months or vaccine at 12 months.      Blood will be drawn for titers twice from all participants: pre-dose 1 and one month post     third dose. We hypothesize that the GMTs in the test group (T) are non-inferior to the usual     timing control group (C):      H0: δ ≤ −δ0 versus H1: δ > −δ0 where δ = log (GMTT )− log (GMTC) and δ0 is the pre-specified     non-inferiority margin.   "
208602|NCT00572845|"     The purpose of this study is to determine if there is a relationship between spasticity and     relative changes in Basal Energy Expenditure in persons with spinal cord injury.   "
208603|NCT00572858|"     For unexplained reasons, young premenopausal women with heart disease have twice the rate of     death compared to men of the same age. Animal experiments have shown that stress can reduce     ovary function in females monkeys due to reductions in brain hormones. This stress and     reduced brain hormone levels lead to low estrogen levels and can cause menstrual cycles to     become irregular, leading to reductions in fertility. These monkeys are also more likely to     develop heart disease. In order, to better understand this relationship the investigators     would like to study estrogen levels in premenopausal women with heart disease.      Premenopausal women who have recently undergone a study of their coronary (heart) arteries     will have their blood hormone levels measured over one menstrual cycle. The investigators     will correlate the blood hormone levels with coronary angiography results and with other     markers of heart disease, such as a test that uses noninvasive, painless ultrasound waves to     study the thickness of the arteries in the neck (carotid arteries). In addition blood     cholesterol levels, blood sugar levels and other blood tests have been shown to correlate     with heart disease will be measured.      Another aim of the study is to evaluate a potential link between environmental stress and     hormone levels. Each patient will be given multiple questionnaires to evaluate stress,     anxiety and depression and the investigators will be measuring the stress hormone (cortisol)     levels in saliva for additional information.      The results of the study will further explore a possible link between low estrogen levels and     heart disease in young premenopausal women and help pave the way for larger research studies     to define better ways of preventing heart disease in these women.   "
208604|NCT00572871|"     We are interested in determining if there exist a short-term response in the serum markers     and hormones that participate in the regulation of bone tissue formation and breakdown to a     single, high-intensity exercise session of weight lifting (resistance exercise) or jumping     (plyometrics). We are also interested in determining if the bone marker response to exercise     is altered by changing the negative energy state caused by the exercise treatment, when     subjects are given a moderate calorie meal.   "
208605|NCT00572884|"     Military personnel are exposed to the insecticide permethrin when using the DOD Insect     Repellent System. A urinary metabolite of permethrin that is in high abundance and is     relatively stable may be an ideal biomarker of exposure to this pesticide. Monitoring such a     biomarker can prevent over-exposure. The objectives are to identify the most abundant human     urinary metabolite following dermal exposure; to utilize this information to develop rapid     laboratory-based and field portable methods to monitor the degree of an individual's exposure     to permethrin.   "
208664|NCT00582686|"     The purpose of this study is to compare patient functional outcomes for surgical fixation of     calcaneus fractures with and without tricortical iliac crest bone grafting   "
208665|NCT00582699|"     The purpose of this study is to measure certain specific chemicals in your blood, produced by     the body in response to a stress, such as having pancreatic cancer. These chemicals are     called cytokines and the researchers doing this study want to look at the role they may     play in developing depression.   "
208735|NCT00583622|"     The goal of this clinical research study is to learn if bevacizumab, when given in     combination with gemcitabine, docetaxel, melphalan and carboplatin, or with topotecan,     cyclophosphamide and melphalan (if you are older than 60 or have an allergy to carboplatin),     can help to control ovarian cancer during a stem cell transplant. The safety of this drug     combination will also be studied.   "
209684|NCT00597181|"     The less invasive nature of the Ex-Press Mini shunt with mitomycin C induces less     post-operative inflammation than trabeculectomy with mitomycin c.   "
208606|NCT00572897|"     Stem cell transplantation is used to treat may types of diseases. There a 2 types of     transplants, conventional (very intense) and reduced intensity-non-myeloablative, also called     mini-transplants.      This study proposes to use a conditioning regimen for allogeneic transplantation along with a     reduced intensity transplant. Conditioning regiment is the name for the combination of     chemotherapy drugs that is given to patients before receiving a transplantation of donor stem     cells. It is hoped that the regimen designed for this study proves to be less toxic and has     an equal or better anticancer effect than the regimens that are normally used. The regimen     being used is a combination of two chemotherapy drugs, fludarabine and melphalan. This     regimen has been studied in recipients of matched sibling transplants and in recipients of     alternative donor stem cells in other hematologic malignancies. Those subjects, who receive     stem cells from an unrelated donor, will also receive and additional drug called ATG or anti     thymocyte globulin. ATG suppresses the immune system, thus reducing the chances for the     recipient rejecting the transplant (graft).      The purpose of this study is to observe if reduced intensity transplants can be used to allow     engraftment or take of the donor's bone marrow. Studies conducted in the past show this     type of transplant is much less toxic than traditional bone marrow transplants. Reduced     intensity transplants may be better tolerated by patients who may experience serious side     effects from standard (very intense) stem cell transplant.      The study has been recently amended to follow all subjects for survival.   "
208607|NCT00572910|"     This is a study to evaluate the safety and immunogenicity of V710 with and without Merck     Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on     hemodialysis.   "
208608|NCT00572923|"     Our group has shown that the omission of elective nodal irradiation on the basis of CT scans     in patients with LD-SCLC lead to a higher than expected isolated nodal recurrence in the     ipsilateral supraclavicular area. We have previously also shown that selective mediastinal     nodal radiation on basis of FDG-PET scans in NSCLC is safe and reduces the radiation fields     and hence toxicity. As the accuracy of FDG-PET scans is also in SCLC higher than CT, we will     investigate the safety of selective nodal irradiation in LD-SCLC patients treated with     concurrent chemo-radiation.   "
208609|NCT00572936|"     This study is designed to identify physiological, pharmacological and pathological circadian     fluctuations in aqueous humor inflow and outflow, systemic blood pressure and ocular blood     flow in humans.   "
208610|NCT00572949|"     The purpose of this research study is to evaluate a better way of diagnosing heart artery     disease, heart attack and damage to the heart muscle early on. Currently, it often takes     several hours after admission before lab tests will show that there has been any damage to     the heart muscle. Although the standard electrocardiogram is quick and non-painful it may     miss many cases of significant coronary heart disease. The investigators are proposing that a     new entirely non-contact tool, the Magnetocardiograph (MCG), with high accuracy is able to     predict the presence of significant coronary heart disease early on before other studies     become positive. The investigators hope by this that the investigators can develop an     algorithm for better triage and management of patients with chest pain.      This research study is designed to test the effectiveness of the investigational use of the     Magnetocardiograph (MCG) that has been approved by the U.S Food and Drug Administration     (FDA). While the MCG used in the study is FDA-approved as a tool for the non-contact     measurement and display of the magnetic fields of the heart generated by the electrical     currents, it is not yet approved for the specific diagnosis of heart artery disease     (ischemia).   "
208611|NCT00572962|"     1. General: antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30          minutes before surgery        2. Laparoscopic surgery             -  at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)             -  with or without anchoring transparietal sutures or double crown technique   "
208612|NCT00572975|"     *The purpose of this study is to develop a more accurate, reliable, specific and more     acceptable alternative clinical test to the 72-hour stool and diet collection for quantifying     fat malabsorption in people with CF and pancreatic insufficiency.   "
208613|NCT00572988|"     The major purpose of this experimental study is to test the effects of the symptom management     home care nursing intervention (SMHCNI) on recovery outcomes of elderly CABG patients, using     a randomized, two group (n=284) repeated measures design with measurements at discharge, at 3     and 6 weeks, and 3 and 6 months postoperatively. One group will receive the intervention and     routine care (RC) and the other group will receive RC only. The major aim will be to     determine if the intervention group will demonstrate: better physiological functioning     (decreased symptom interference on physical functioning; better scores on the SF36 subscales:     physical, role-physical and vitality, and increased activity and exercise energy     expenditure); better psychosocial functioning (decreased symptom interference on enjoyment of     life; and better SF36 subscales; role-emotional, social, mental, and vitality); and fewer     postoperative problems (e.g. infections, fluid in lungs, heart rate rhythm problems).     Additional outcomes for secondary aims are: lower levels of health care utilization (HCU)     (i.e., fewer number of visits to health care providers, fewer number of emergency department     visits, fewer number of home health visits, fewer rehospitalizations); and higher patient     satisfaction (with level of functioning and care received). In addition this study will     examine the potential effects of mediating (evaluation of symptoms, and perceived     self-efficacy), and moderating variables (participation in cardiac rehabilitation) with the     intervention on outcomes identified.   "
208614|NCT00573001|"     The goal of this trial is to demonstrate that new treatments are as effective as a reference     triple-agent regimen in driving plasma viral load below the detection limit early during     treatment (16 weeks). These simplified treatments involve fewer tablets and intakes,     fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor     and tenofovir.   "
208691|NCT00583037|"     Neurally Adjusted Ventilatory Assist (NAVA) is a new mode of mechanical ventilation that is     controlled by the electrical activity of the diaphragm (EAdi). The EAdi is a signal that     represents the patient's breathing effort, and hence with NAVA, the assist being delivered is     synchronized and proportional to the demands of the patient. This is a prospective     physiological study of the feasibility of NAVA ventilation over 24 hours. The aim is to     demonstrate that NAVA can maintain spontaneous breathing and unload the respiratory muscles     during both sleep and wake cycles over a 24 hour period.   "
208616|NCT00573027|"     Women suffer disproportionately than men from Cardiac Syndrome X ( chest pain in the absence     of flow limiting coronary artery stenosis). Coronary microvascular disease is hypothesized to     mediate chest pain in this syndrome. This disorder of the small heart vessels (arterioles)     compared to the large vessels (arteries) is not diagnosed during routine heart     catheterization. This results in delays in diagnosis, missed opportunities for treatment, and     likely contributes to the increased death rate from coronary heart disease in women compared     to men.      Current testing for small vessel disease is performed in the cardiac catheterization     laboratory using specialized testing and is not performed routinely. Accordingly, women with     this condition are either falsely reassured, or misdiagnosed as another non-cardiac     condition. Unnecessary healthcare costs related to re-hospitalization and repeat angiography     are incurred, while women are often not initiated on appropriate lifesaving treatment. We and     others have demonstrated in randomized controlled trials that therapies that target the     endothelium, e.g. statins, ACE inhibitors, and exercise are effective in this condition.      Majority of women with Cardiac Syndorme X go undiagnosed. Recent studies have shown     significant increased health care costs, morbidity and mortality related to this disease. It     is becoming more important to further characterize this group of patients and we hope to do     that with our study.   "
208617|NCT00573040|"     Our group has shown in a modeling study that increasing the radiation dose to pre-specified     normal tissue dose constrains could lead to increased TCP with the same NTCP. In a subsequent     phase I trial, the investigators showed the safety of this approach. Here, the investigators     want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC,     who are selected for radical radiotherapy   "
208618|NCT00573053|"     To determine whether targeting lower arterial oxygen saturations from the day of birth alters     the early (first 3 months) postnatal development of the control of ventilation and the     hypercapnic and hyperoxic responses in very preterm infants.   "
208619|NCT00573066|"     This study is being conducted to determine what dexmedetomidine does to the body and in turn,     what how the body handles the medication. This medication, for the purpose of this trial, is     used as a short-term sedative for infants who are immediately post-operative from cardiac     surgery and have a breathing tube and are breathing with the assistance of a mechanical     ventilator or breathing machine.   "
208620|NCT00573079|"     Our first Aim is to describe how common a sudden decrease in renal function happens in     premature infants in a neonatal intensive care unit. We also want to see how a sudden loss of     renal function affects survival. Finally, we will explore non-invasive markers to identify a     sudden decrease in renal function from urinary samples.   "
208621|NCT00573092|"     High blood pressure is one of the most common health problems in the United States. There are     many drug treatment options for high blood pressure, but these medications are not always     effective. People with treated high blood pressure can still suffer from other serious     cardiovascular health problems, including heart attack, sudden death, or stroke. Genetic     variations may cause some people to be more susceptible to these cardiovascular outcomes     despite treatment. This study will identify new gene regions that may influence the     effectiveness of high blood pressure drugs in preventing the above mentioned cardiovascular     conditions.   "
208622|NCT00573105|"     1. General           - antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes          before surgery        2. Laparoscopic surgery             -  at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)             -  with or without anchoring transparietal sutures or double crown technique   "
208623|NCT00573118|"     Congenital and acquired thrombophilia were identified as risk factors for thrombosis in     systemic vessels.Thrombophilias have also been recently found to be associated with     preeclampsia, intrauterine fetal growth restriction (IUGR), placental abruption, intrauterine     fetal death (IUFD) and repeated pregnancy loss.These severe pregnancy complications are     thought to result from thrombotic events occurring in the uteroplacental circulation.     Accumulating data have established an association between elevated plasma activity of factor     VIII and thrombosis although the mechanism is still not defined and elevated factor VIII     activity is now regarded as being equivalent to thrombophilia.      We intend to investigatthe association between factor VIII levels and severe pregnancy     complications which are considered to result from placental vascular pathology, i.e.,     preeclampsia, IUGR, placental abruption and IUFD. We hypothezise that the prevalence of     elevated factor 8 will be higher among women with pregnancy complications compared to     controls.   "
208624|NCT00581529|"     This is a phase I- II feasibility study for delivering partial breast irradiation (PBI) in     selected patients with early stage, lymph node negative, breast cancer after     breast-conserving surgery using accelerated Intensity Modulated Radiotherapy (IMRT).   "
208625|NCT00581542|"     The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and     Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications     are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study     will investigate if both of the medications are equally good.   "
208626|NCT00581555|"     The purpose of this study is to evaluate the use of etanercept as a replacement therapy for     ciclosporin in patients with plaque psoriasis.   "
208627|NCT00581568|"     Cryogen Spray Cooling spurt is applied to the skin surface immediately before laser exposure.     As liquid cryogen rapidly evaporates, the superficial skin temperature is reduced as a result     of supplying the latent heat of vaporization. Tetrafluoroethane, an environmentally     compatible, non-toxic, non-flammable freon substitute, has been demonstrated in multiple     studies to be a safe and effective cooling agent and is the only cryogenic compound currently     approved for dermatologic use by the Food and Drug Administration.   "
208666|NCT00582712|"     Primary objective is to evaluate the tumor response rate of patients with MTC treated with     Lithium carbonate   "
208667|NCT00582725|"     Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin,     vincristine, and prednisone), with GM-CSF.   "
208668|NCT00582738|"     This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in     liver transplant patients who have a recurrence of hepatitis C viral infection in the     transplant   "
208834|NCT00584909|"     The main purpose of this study us to determine the best treatment for patients with     endometrial cancer who are at an elevated risk for recurrence.   "
208628|NCT00581581|"     This observational study will assess long-term functional outcome of survivors from neonatal     encephalopathy who were previously treated with either head cooling or with conventional care     in a randomized clinical trial. Children's parents will be interviewed by phone by trained     staff using the WeeFIM questionnaire to ascertain the childrens' functional performance on a     set of skills basic to daily life. This instrument is able to assess a very wide range of     abilities, from independently functioning to needing total assistance. The ratings will be     used to examine the relationship between the outcome previously measured at 18 months age and     functional outcome at school age and to triage the children into those who clearly could not     be tested on standardized exams of cognitive functioning, those who potentially could, even     if at a low level of cognitive ability, and those who appear to be functioning at an     age-appropriate level.   "
208629|NCT00581594|"     Women who undergo posterior colporrhaphy with graft augmentation will have a lower recurrence     of their posterior wall defect than women who undergo a traditional posterior colporrhaphy.   "
208630|NCT00581607|"     Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary     hypertension is a condition where the right side of the heart has to push the blood though     the lungs at a higher pressure than normal. Since this pressure is higher, it is harder for     the heart to pump the blood through the lungs to the left side of the body. If the blood can     not get through the lungs, it can not get pumped through the rest of the body. This leads to     weakness and shortness of breath. This type of hypertension does not usually respond to     regular blood pressure medicines. The purpose of this study is to determine if bosentan     (Tracleer) will help sarcoidosis associated pulmonary hypertension.   "
208631|NCT00581620|"     To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with     immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.   "
208632|NCT00581633|"     The investigators will test the hypothesis that patients with chronic orthostatic intolerance     or postural orthostatic tachycardia syndrome (OI or POTS) will be unable to conserve urinary     sodium as compared to healthy control subjects.   "
208633|NCT00581646|"     This study aims to learn about the needs and feelings of women who are infertile. Being     infertile means not being able to have a child without the help of a third party. There are     other options for building a family. The researchers are interested in the participants'     thoughts about these options and want to learn about the experiences of infertile women due     to cancer treatment as well as women who are infertile due to other causes. The researchers     hope that what they learn will allow them to better care for infertile women in the future.   "
208634|NCT00581659|"     The objective of this study is to quantify differences in nighttime driving performance     between the Bausch & Lomb PureVision™ aspheric contact lenses and a conventional spherical     contact lens.      The primary aims of this study are to determine the differences between B&L PureVision™     aspheric contact lenses and a conventional spherical contact lens in visual performance     measures associated with driving, such as number of objects seen.      The secondary aims of this study are to determine differences between B&L PureVision™     aspheric contact lenses and a conventional spherical contact lens in driving performance     measures such as number of objects hit.   "
208635|NCT00581672|"     This study is being done to see if a standard tool used to check anxiety in white men works     well for Black men. The tool is used only for men who have prostate cancer. It is meant to     see how the cancer affects men. If the investigators have a good tool, it is more likely that     the investigators can help those who have high levels of anxiety. This test is known as the     Memorial Anxiety Scale for Prostate Cancer (also called the MAX-PC).   "
208636|NCT00581685|"     Despite the development of new pain medications, the prevalence of persistent postoperative     pain (for more than three to six months) remains alarmingly high. Chronic pain and reduced     function after surgery are of great concern since they have a significant impact on a     patient's quality of life and are costly to society in terms of longer hospital stays and     lost work days. An important risk factor for chronic pain and reduced function after surgery     is the amount of pain patients experience immediately after surgery which is highly     influenced by the amount of pain patients have preoperatively. For many patients,     longstanding pain prior to surgery is common and thus can compromise the outcome of the     procedure. Therefore, the aim of this study is to reduce the amount of pain patients have     before they undergo surgery by administering a novel pain-relieving regimen in the weeks     before surgery. Crucially, this treatment will be continued for three weeks after surgery to     reduce pain that arises from the surgical trauma. The novel regimen will include a     non-steroidal anti-inflammatory (celecoxib) and the alpha2 delta ligand, pregabalin. This     drug combination will provide the best opportunity to target several key sites in the pain     pathway. This regimen will be tested in patients with pain related to osteoarthritis and who     are undergoing orthopedic (hip) surgery because chronic preoperative pain is common in these     patients and is the main reason for undergoing surgery. The goal of this research proposal is     to adequately manage pain before and after surgery in order to improve function weeks after     surgery. If controlling pain in this way does lead to improved long term postoperative     function the findings from this study may lead to the development of a standardized regimen.     This is highly relevant not only for orthopedic procedures but following other common     surgical procedures which would be of great benefit to patients and the entire healthcare     system.   "
208637|NCT00581698|"     The purpose of this study is to determine whether we can consistently identify the first     lymph node (the sentinel node) draining your melanoma.   "
208638|NCT00581711|"     This protocol will prospectively develop a new electronic health record (EHR)-based health     information technology (IT) intervention that a) summarizes Otitis Media (OM) care into     clinically meaningful episodes-of-care, b) provides clinical decision support based upon     evidence-based guidelines to primary care and ENT physicians working within an integrated     physician network that uses a common EHR, and c) tests the additive effects on quality and     resource utilization of providing feedback to physicians.   "
208639|NCT00581724|"     The purpose of this study is to find out about the pain and quality of life of individuals     who are adult cancer survivors. By quality of life, we mean how you are feeling about     different aspects of your life, including your physical health, your emotional health, and     your ability to carry out daily activities. We are interested in people's opinions about     their quality of life, as well as the factors that affect their quality of life. In addition,     learning about pain will help us to develop new services for adult cancer survivors.   "
208669|NCT00582751|"     To compare the volumetric response achieved using semi-automated computer techniques with the     uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running     at MSKCC, testing new agents for different types of solid tumors.   "
208835|NCT00584922|"     The purpose of this study is to prospectively follow the next 200 patients who undergo     catheter ablation of atrial fibrillation for symptoms and signs of esophageal injury.   "
208640|NCT00581737|"     The purpose of this study is to evaluate several aspects of thinking abilities including     attention and memory, and quality of life in patients who were diagnosed with and treated for     Primary CNS Lymphoma (PCNSL), and are in remission of their disease. The findings of this     study may help us understand whether this disease and its treatment may have affected some     patients' thinking skills, and may provide important information that can be used to develop     programs to improve the quality of life of patients with PCNSL.      This research will also study whether persons having particular types of genes involved in     the metabolism of methionine (5-methyltetrahydrofolate-homocysteine S-methyltransferase-MTR,     MTFH reductase-MTFHR, transcobalamin 2-Tc2), and apolipoprotein E (APOE) are more likely to     have delayed adverse effects after treatment for their tumors. The findings of this study may     help us understand whether this disease and its treatment may have affected some patients'     thinking skills, and whether this may be related to having certain genes.   "
208641|NCT00581750|"     This study is being done in order to better understand the biology of an abnormal lesion     found in breast tissue called lobular carcinoma in situ (LCIS). We are interested in     studying LCIS. The LCIS is not a cancer itself, but is a marker for an increased risk of     cancer. We would like to look for LCIS in breast tissue removed during surgery from patients     with cancer or at high risk for cancer. If LCIS is found, we will search for genes that are     expressed (turned on or off) differently than in normal breast tissue. The identification of     such genes would help us better understand the biology of LCIS, and its possible relationship     to breast cancer.   "
208642|NCT00581763|"     This is a study about why some people have certain types of proteins in their blood, called     anti-phospholipid antibodies. The presence of these antibodies and associated complications     (e.g. blood clots) are known to change over time. The purpose of this study is to evaluate     these changes and improve our ability to determine the long-term outcome of affected     individuals.   "
208643|NCT00581776|"     Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine,     Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4)     , then one dose of rituximab every 12 weeks until 5 years or disease progression.   "
208644|NCT00581789|"     -  To determine the safety and maximally tolerated dose of sunitinib plus erlotinib in          patients with non-small cell lung cancer (NSCLC).        -  To determine response to sunitinib plus erlotinib in patients with non-small cell lung          cancer.   "
208645|NCT00581802|"     The purpose of this observational study is to characterize which immune system cells hide the     latent reservoir of HIV by counting the number of latent HIV in different subsets of CD4     cells. Observations will also be made on other possible mechanisms of HIV persistence by     looking at cellular factors such as APOBEC3 and drug transporters. The purpose of this study     is to develop new strategies to reduce and possibly eliminate the latent reservoir in HIV     infected adults.   "
208646|NCT00581815|"     The purpose of this study is to obtain chemical information from part of your body without a     biopsy. This is done using a technique called magnetic resonance spectroscopy (MRS) which is     similar to magnetic resonance imaging (MRI) except that signals are detected from the     chemicals (spectroscopy) naturally present in your body using radio waves. To receive this     information from your body, small loops of wire (surface coils), placed near the tissue of     interest, may be used to more effectively detect signals that come from the chemicals in your     body. The investigators may use a second radio channel simultaneously, which will allow us to     obtain greater chemical information (decoupling). The results may also help us to understand     how this study can be used to help other patients with your condition.   "
208647|NCT00581828|"     The purpose is to perform a one-year study designed to assess whether treatment of     hypovitaminosis D increases intestinal absorption of calcium, subsequent retention of calcium     within bone, decreases bone turnover, and favorably impacts upon skeletal muscle mass,     functional status, measures of physical function and quality of life. I hypothesize that     treatment of hypovitaminosis D results in improved intestinal calcium absorption, greater     retention of calcium within the bone reservoir and improved physical function, quality of     life and muscle mass.   "
208648|NCT00581841|"     The purpose of this preliminary substudy to the parent study Aerobic Exercise Intervention     for Knee Osteoarthritis is to determine the repeatability and reproducibility of various     measurement techniques.   "
208649|NCT00581854|"     rituximab and modified (hyperCVAD) administered every 28 days for 4-6 cycles followed by     rituximab maintenance therapy consisting of four weekly doses every six months for two years   "
208650|NCT00582491|"     Subjects participating in this protocol will participate in three phases: 1) pre-admission,     2) inpatient admission, and 3) follow-up. Pre-admission involves screening (detailed in     inclusion/exclusion criteria section) and one week of outpatient sleep and activity     monitoring. Inpatient admission is 16 consecutive nights on the Clinical Neuroscience     Research Unit and involves subjective and objective tests of sleep, sleepiness, attention,     and learning. During inpatient admission subjects will take modafinil or placebo. For     follow-up, subjects will return to the CNRU for one night and again participate in objective     tests of sleep, sleepiness, attention, and learning. We hypothesize that modafinil will     decrease subject and objective measures of sleepiness and will promote attention and learning     in cocaine dependent persons.   "
208651|NCT00582504|"     This study is designed to determine safety of and immune response to Venezuelan Equine     Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).   "
208652|NCT00582517|"     The purpose of this project is to evaluate the effect of the Compass™ Universal Hinge     external fixator on the outcome of patients following acute dislocation of the knee   "
208653|NCT00582530|"     The purpose of this study is to see if the protein pattern in your blood can predict whether     or not your prostate tumor is aggressive. We will use a new and very sensitive technique,     called mass spectroscopy, to measure hundreds of pieces of protein in your blood. A computer     will make a picture of the protein pattern. We will do this in 500 men before their prostate     surgery and see if there is a pattern that predicts what the tumor looks like under the     microscope. We will also check the protein pattern in your blood 6 weeks to 12 months after     the surgery to see if your pattern changes.   "
208680|NCT00582894|"     To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients     who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for     malignant hematological diseases   "
208654|NCT00582543|"     The purpose of this study is to see if magnetic resonance imaging (MRI) and magnetic     resonance spectroscopic imaging (MRSI) can tell which patients with prostate cancer are at a     low risk for their cancer growing and spreading. Magnetic resonance methods use magnets and     radio waves to take pictures of body structure (MRI) and to measure amounts of important     chemicals within the body (MRSI). This study will look at the structural and chemical     properties of prostates before undergoing treatment. Hopefully, doctors will be able to use     this method before making treatment decisions for patients with newly diagnosed cancer of the     prostate. This study will continue our work to assess the value of MRI/MRSI in addressing     what is currently one of the greatest clinical challenges in the management of prostate     cancer: the identification of low-risk organ-confined prostate cancer that can be managed     expectantly with deferred treatment.   "
208655|NCT00582556|"     The purpose of this research is to determine the effect of timing of Zometa® administration     on bone mineral density of the lumbar spine and femoral neck in men undergoing androgen     deprivation therapy for prostate adenocarcinoma. In addition, the researchers will also     determine the effects of treatment with Zometa® on peripheral blood markers of bone turnover,     on peripheral blood gd T-cell frequencies and function, and to determine if the above     treatments elicit prostate antigen-specific IgG immune responses. The effects of the above     treatments on serial serum PSA measurements will also be examined.   "
208656|NCT00582569|"     The purpose of this new imaging method is to provide physicians with additional information     not available with standard imaging methods. This includes information about the make up of     different breast diseases. Using spectroscopy data, it may be possible to tell the difference     between benign conditions of the breast from malignant tumors and provide more accurate     information than can be obtained with regular MRI. Along with the MRI a new method of     evaluating the images or pictures will be used. This new method is called spectroscopy and is     used routinely on other parts of the body such as the prostate and brain. Pictures produced     with this sequence look different than the regular MRI pictures. Performing spectroscopy on a     1.5T magnet adds another imaging sequence (another scan) to the routine MRI protocol, thus     increasing exam time (extra 10-15 minutes). This study will enroll patients who are scheduled     for a Magnetic Resonance Imaging (MRI) examination ordered by their primary physician.   "
208657|NCT00582582|"     The purpose of this research study is to find out the toxicities of doxercalciferol given in     combination with docetaxel (Taxotere®), as well as to see how well this combination works in     the treatment of prostate cancer.   "
208658|NCT00582608|"     The purpose of this study is to find out whether the monoclonal antibody 8H9 is useful in     finding tumors in your body. Antibodies are protein found naturally in blood. They can fasten     themselves to bacteria and viruses. They can stimulate white cells and blood proteins to kill     tumors. The antibody 8H9 was made from mouse white cells. The white cells that secrete this     antibody have been made to live for ever. They manufacture large amounts of 8H9 for patient     use. Although other monoclonal antibodies have been safely tested in people, the antibody 8H9     has never been given to a human patient.   "
208659|NCT00582621|"     The purpose of this study is to better understand the genetic causes of Hodgkin's disease (a     kind of lymphoma) and non-Hodgkin's lymphoma, as well as multiple myeloma, leukemia, and     related diseases. The doctors have identified the patient because 1) they have had a     lymphoproliferative disorder such as lymphoma, leukemia, or multiple myeloma, and have a     family member with one of these disorders or 2) they are a member of a family with a     lymphoproliferative disorder, including Hodgkin's disease and/or, non-Hodgkin's lymphoma or a     second cancer after Hodgkin's disease.   "
208660|NCT00582634|"     -  To determine if docetaxel and cisplatin can be administered in a dose intense manner in          the adjuvant setting in resected non-small cell lung cancer        -  To evaluate the time to progression and overall survival        -  To evaluate toxicities of this chemotherapy combination in the adjuvant setting        -  To correlate XPD and ERCC1 polymorphisms with time to progression and toxicities in          patients treated with this regimen   "
208661|NCT00582647|"     Doctors at Memorial Sloan Kettering Cancer Center and at other institutions study normal and     cancer cells. To study these cells we need to have human tissue, body fluids, and blood. The     patient will be having or have had a procedure to remove tissue. The doctors would like to     use some of this tissue. The doctors will use it for laboratory studies on the causes,     prevention, diagnosis and treatment of sarcoma, gastrointestinal or other intra-abdominal     cancers. They will only use extra tissue left over after all needed testing has been done.     They would also like to study components of the immune blood cells and blood serum (the     liquid portion of the blood). In some patients they will take a blood sample before the     tissue or body fluid is removed, usually at the same time that other routine pre-procedure     blood tests are drawn. If thet need more blood, it will be drawn when the patient is seeing     the doctor anyway. We will not draw more than 50cc (4-5 tablespoons) at any one time. With     the patient's permission, thet may also send a small portion of the blood and/or a sample of     the tissue to a repository at the National Cancer Institute. This will be used to identify     special proteins in the blood or tissue that may be useful for diagnosing cancer. Information     about the treatment and the response to treatment may be linked to the tissue specimens     obtained. This information may be important for the research studies that will be done on the     tissue, body fluid and blood specimens. All of this information will be kept in strictest     confidence; they will use it only for biomedical research. The patient's name will not be     used in any report.   "
208662|NCT00582660|"     The purpose of this study is to assess how effective celecoxib is in limiting production of a     hormone, prostaglandin, in the subject's body. It is felt that this hormone is involved in     the evolution of pre-cancerous growths in the colon to cancerous stage or in the progression     of an existing cancer. To answer this question, some subjects are given the new     investigational drug, and other subjects a placebo. A placebo is a capsule that contains     inactive ingredients. Only by comparing the response of two subject groups, one receiving     placebo (inactive), and one receiving celecoxib (active), will we be able to know whether or     not celecoxib actually works. The outcome we are assessing is the hormone activity before and     after celecoxib is given.   "
208663|NCT00582673|"     This study will evaluate the safety and efficacy of administration of AFQ056 in combination     with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease     patients.   "
208670|NCT00582764|"     The purpose of this study is to see if dynamic contrast enhanced (DCE) MRI imaging makes it     possible to distinguish benign conditions of the breast from malignant tumors and provide     better information than can be obtained with regular MRI. DCE MRI uses a new way of     collecting and analyzing the images or pictures which provides doctors extra information not     available with standard imaging methods. This includes information about the blood vessels of     different breast diseases. Pictures produced this way look just like the regular MRI     pictures. The DCE MRI adds another imaging sequence (another scan) to the MRI examination     ordered by your physician to evaluate your breast lesion, thus increasing the exam time     (extra 10 min). The information gained from doing the new test, the DCE MRI, will not be used     in your treatment and will not affect the type of care you receive for your breast lesions.   "
208671|NCT00582777|"     4. Methods 4a. Overview The study will be conducted in participants in the African-American     Study of Kidney Disease (AASK) Cohort study as a randomized three period cross-over trial.      Eighty five percent of AASK cohort participants are currently on an ACE inhibitor or     angiotensin receptor blocker; the most commonly used ACE inhibitor is ramipril. The new     strategies proposed in this pilot study will remain ramipril-based, to maintain the overall     blood pressure control achieved thus far.      The antihypertensive regimens proposed are as follows:        -  AM dosing of ramipril and other once daily medications in the participants          antihypertensive regimen (termed USUAL),        -  Bedtime dosing of ramipril and other once a day medications in the participant's          antihypertensive regimen (termed HS-DOSING), and        -  their current antihypertensive regimen plus an additional antihypertensive agent dosed          at bed time; the choice of the additional agent will be tailored based on prespecified          clinical guidelines (termed ADD-ON DOSING)      The usual arm serves as the comparator arm. The hs dosing and add-on dosing arms test     practical strategies that could be tested in a subsequent clinical outcomes trial and that     could be implemented in clinical practice. We hypothesize that both arms will reduce     nocturnal BP in comparison to usual dosing. We further hypothesize that the hs dosing arm     will raise daytime BP somewhat but have no net effect on 24 hour BP and that the add on     dosing arm will have no effect on daytime BP but lower 24 hour BP.      This pilot study will begin after the last scheduled AASK Cohort study visit. Eligible     participants will be treated for 6 weeks on each of 3 antihypertensive regimens. The sequence     of the regimens will be random. Each period of the three periods will have 2 visits, one     visit at 3 weeks and one visit at 6 weeks. In the last week of each 6-week period, a 24-hour     ABPM will be obtained. The primary outcome variable is nocturnal BP; each pair wise     difference between the regimens will be calculated.   "
208672|NCT00582790|"     This study is being done to see if we can improve the response of Interleukin-2 by adding     Zoledronic acid. The effectiveness of the combination of drugs in kidney cancer is unknown     and will be investigated in this study. In particular, this study will evaluate the effect of     this combination on kidney cancer and will also examine the safety and side effects of IL-2     with Zoledronic acid.   "
208673|NCT00582803|"     Women with strong family histories of breast cancer are at increased risk to have breast     cancer. Women whose close relatives have had breast cancer often have more breast cancer     screening than other women their age. To increase the chance that any breast cancer will be     caught early, women at risk often take part in special screening programs. These programs     involve more frequent visits to the doctor for breast exams, yearly mammography, and new     types of exam like breast Magnetic Resonance Imaging (MRI). Studies are going on to find out     whether these programs are better than standard screening. The purpose of this study is to     find out how these programs impact women's quality of life. The study will also try to learn     what factors make it hard to take part in the programs. We hope to be able to design new     programs that are easier to follow.   "
208674|NCT00582816|"     This study will assess the feasibility of utilizing a reduced intensity conditioning regimen,     in the setting of haploidentical transplantation, for patients with recurrent acute     lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the     feasibility and safety of administering post-transplant NK cell infusions will be evaluated.     Data obtained from this study will help determine the efficacy of allogeneic HSCT in the     treatment of pediatric sarcomas and add to the small body of literature utilizing     haploidentical HSCT to treat acute leukemia in pediatric patients. This study will also     further elucidate the role of NK cells in mediating a graft vs. tumor effect in allogeneic     HSCT. The main benefit to society is that this study will explore a novel therapy for     children with highly refractory cancer who are felt to be incurable with conventional     approaches. If feasibility is demonstrated, and there is evidence of anti-tumor activity,     then this will open up a new area of clinical research to better define the efficacy of this     approach for specific childhood malignancies.   "
208675|NCT00582829|"     This proposed study will use previous study results to guide the development and evaluation     of interventions to improve CRC screening acceptance. The proposed study will evaluate the     impact of three interventions to promote CRC screening among siblings in this increased-risk     group, who are not currently compliant with CRC screening guidelines: 1) a generic print     intervention; 2) a tailored print intervention, and; 3) a tailored print plus tailored     telephone counseling intervention.   "
208676|NCT00582842|"     The purpose of this study is to assess quality-of-life of men with prostate cancer.     Quality-of-life means how you feel about your life as a result of your disease and its     treatment. The investigators hope that this questionnaire will help show how prostate cancer     treatments affect quality-of-life. It will help doctors and future patients to make better     treatment choices. Some men may wish to have a more demanding treatment with a higher risk of     harmful effects. Others may prefer a treatment that will have the smallest effect on their     quality-of-life.      This questionnaire will help us measure these effects and decide which is the best treatment     for a given patient.   "
208677|NCT00582855|"     This study will investigate AQW051 in patients with either mild Alzheimer's disease or     amnestic mild cognitive impairment. The effect on cognitive impairment will be measure using     validated computerized tests which measure cognitive function. This study will also explore     the safety and tolerability of AQW051 in these patients.   "
208678|NCT00582868|"     The purpose of this study is to investigate if brain oxygen levels, levels of a specific     protein in the cerebrospinal fluid and blood (Cleaved-tau protein), and brain blood flow can     predict spasm of brain blood vessels after bleeding in the brain from a ruptured aneurysm.   "
208679|NCT00582881|"     Systemic lupus erythematosus (SLE) and mixed connective tissue disease (MCTD) are long-term     autoimmune diseases in which the immune system attacks parts of the body. The abnormal immune     reaction causes inflammation of and damage to various body parts and can affect joints, skin,     kidneys, heart, lungs, blood vessels, and the brain. SLE and MCTD often affect young women,     especially black and Hispanic women, and there is no known cure. Knowing more about SLE and     MCTD will help in developing new and effective treatments. The purpose of this study is to     characterize immune system abnormalities, genetic components, and disease progression in     people with SLE and MCTD.   "
208681|NCT00582907|"     Familial Mediterranean fever (FMF) is a genetic disease resulting in recurrent attacks of     fever, abdominal pain, chest pain, arthritis and rash. There are 5-15% of patients who     continue to have FMF attacks despite treatment with colchicine or who cannot tolerate     colchicine. Currently there are no alternatives to colchicine. Pyrin, the protein that has a     defect in FMF has an important role in the regulation of a molecule called interleukin (IL)-1     beta production and activity. This molecule is very important in the process of inflammation     in FMF.      Therefore we propose to use IL-1 Trap (Rilonacept), a medication that binds and neutralizes     IL-1.      We will enroll in this study 17 subjects from the age of 4 years, including adults with     active FMF despite colchicine therapy. Subjects will receive in random order two 3-month     courses of Rilonacept at 2.2 mg/kg (maximum 160 mg) by weekly subcutaneous injection and two     3-month courses of placebo injection. If patients have at least two FMF attacks during a     treatment course they will be able to get if they choose the other treatment until the end of     that treatment course. Our hypothesis is that Rilonacept will decrease the number of acute     FMF attacks and will be safe to use. This study may confirm the importance of IL-1 in the     cause of FMF.      Funding source - FDA Office of Orphan Products Development   "
208682|NCT00582920|"     The purpose of this study is to examine for changes in the bone scan after treating with     zoledronic acid (Zometa™). This study is designed to show if intravenous (IV)     bisphosphonates, which are infused by vein, such as pamidronate (Aredia™) or zoledronic acid     (Zometa™), cause changes in the result of bone scans in women with metastatic breast cancer.     Both bone scans and the IV bisphosphonates are components of routine care of women with     breast cancer that has spread to the bone.   "
208683|NCT00582933|"     The purpose of this research study is:(1) to determine if high doses of chemotherapy without     total body irradiation can allow selected stem cells to take and grow,(2) to determine if     selected stem cells from the blood or marrow can take and not cause a complication called     graft-versus-host disease (GvHD) and (3) to evaluate the side effects of the combination of     chemotherapy drugs used for these transplants. In the last 10 years we have developed     chemotherapy combinations to be used for this T-cell depleted transplant protocol. By using     three chemotherapy drugs (IV busulfan, melphalan and fludarabine), we hope to have a good     chemotherapy combination to kill cancer cells, and to make the graft take, without the side     effects of total body irradiation. The chemotherapy drugs to be tested in this protocol are     busulfan, melphalan and fludarabine, all of which have been used successfully for stem cell     transplantation, but not given together as in this specific regimen. This is what is being     tested in this study.      Our initial trials in the 1980's with T-cell depleted transplants showed less GvHD, but the     overall results of the transplants were not better. The reason for this was that the stem     cells did not take and engraft in 15% of our adult patients. This failure of the stem cells     to take can leave patients without bone marrow or blood cells necessary for life. Most stem     cell transplants were done using bone marrow (BMA) obtained from the donors. However, if we     give a medication called G-CSF by shots to the donor, we can collect peripheral blood stem     cells (PBSC) and use them for transplant. The advantage of this approach is that we can     collect 2-20 times more stem cells than that obtained from the marrow. It has been proven     that a larger number of stem cells in the graft make it more difficult for the patient to     reject the stem cells. Some donors may be too small to provide peripheral blood stem cells or     they may not want to take G-CSF shots. In these cases the donors will have their marrow     collected in the operating room under general anesthesia.      Stem cell transplants can lead to a condition known as acute graft-versus-host disease or     GvHD. This disease is caused by an assault by certain cells in the marrow or blood (T-cells)     of the donor (graft) against your body (the host). These T-cells see your body as foreign and     attack it. The disease causes a skin rash, liver disease, and diarrhea. Methods were     developed at this institution to prevent GvHD. These methods take out most of the T-cells     (responsible for GvHD) from the marrow or blood stem cells before transplant. This is called     T-cell depletion or stem cell selection. In this hospital, we use two types of methods of     T-cell depletion: one method is used with peripheral blood stem cells and one for bone     marrow. Both these techniques have been successful in preventing both acute and chronic GvHD.     You will receive a T-cell depleted stem cell transplant.   "
208684|NCT00582946|"     Our goal is to design and build a new hearing aid system, which mitigates the most common     complaints that hearing aid users have. These include hearing in multi-talker situations,     poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of     their own voice. Current efforts, with limited success, use signal processing methods rather     than restoring more closely the normal auditory function. We plan to achieve our goal by     reducing to practice three key enabling concepts. The first is to replace the current     acoustic transducer with a non-acoustic mechanical output transducer that directly actuates     the tympanic membrane (TM). This transducer, called the EarLens, floats on the tympanic     membrane in a manner similar to the way a contract lens floats on the eye. The second is to     increase the output bandwidth of the hearing aid. The third key concept is to place a     wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similarly to     the way the normal ear functions. Our central hypothesis is that a hearing aid that delivers     amplified wide-bandwidth mechanical stimuli, directionally dependent cues, in an open canal     configuration will perform better than conventional hearing aids when there are competing     talkers in the background. First phase includes verification the capability of the system to     deliver sufficient maximum equivalent pressure output (MEPO) to treat the degree of hearing     loss in the target fitting range.   "
208685|NCT00582959|"     The purpose of this study is to test a new technology for obtaining x-ray images of your     treatment fields when you are positioned on the treatment machine, to determine whether this     new system is as reliable and easy to use as conventional systems.. These so-called portal     images are normally taken on a weekly basis, prior to your radiation treatment. The new     portal imaging system to be tested is designed to produce better quality images than are     currently achievable, but with no additional dose or added treatment time.   "
208686|NCT00582972|"     The purpose of this study is to measure the effect of omeprazole on intestinal calcium     absorption in postmenopausal women.   "
208687|NCT00582985|"     This study is being performed to evaluate the safety and tolerability of the TRC105     monoclonal antibody.   "
208688|NCT00582998|"     This project is designed as a prospective, randomized, comparative study evaluating the use     of a negative pressure vacuum device in treating soft tissue injuries and the surgical     incision following open reduction and internal fixation of calcaneus, tibial plateau, and     pilon fractures.   "
208689|NCT00583011|"     This study is been designed to answer the question of whether local anesthesia (1% lidocaine)     decreases the perception of pain associated with amniocentesis in a randomized double blind     placebo controlled manner. Our objective is to determine the effect of local anesthesia on     the maternal pain perception from an amniocentesis.   "
208690|NCT00583024|"     This investigational study involves treatment with an Ad/PSA vaccine for men with prostate     cancer who present with evidence of hormone refractory metastatic disease.   "
208733|NCT00583596|"     AGA-004 - The objective of the study is to determine safety, effectiveness and clinical     utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 -     The objective of this study is to evaluate the long term safety and effectiveness issues that     may not have have been adequately addressed during AGA-004.   "
218167|NCT00705484|"     This is a prospective, safety surveillance registry in subjects with moderate-to-severe     active ulcerative colitis (UC).   "
208694|NCT00583076|"     The aim of the study is to assess the safety and efficacy of an investigational agent,     AST-120, in treating patients with active pouchitis. This is an open-label trial which means     that all patients will receive AST-120 in 2g sachets (packets)three times a day for 4 weeks.     All antibiotics, probiotics and nutritional agents must have been discontinued for at least 2     weeks prior to study entry. An initial group of 10 patients will be enrolled. If there are no     serious adverse events associated with the study drug and at least 3 of the 10 patients     respond, a second group of 10 patients will be enrolled. In the second group of patients,     those patients who are considered responders or who are in remission are eligible to receive     open-label AST-120 for as long as response is maintained up to a maximum of 52 weeks.     Patients will have clinic visits at the start of the study and at week 4. If continuing on     open label AST-120 after week 4, patients will have clinic visits every 12 weeks to assess     the continuing safety and efficacy of AST-120. Endoscopies will be performed at the start of     the study, week 4, week 28, week 52 or early termination.   "
208695|NCT00583089|"     To gather data and analyze decompensation events.   "
208696|NCT00583102|"     The purpose of this study is to test the safety and effectiveness of combining a drug known     as Lovastatin to the chemotherapy drug cytarabine. Lovastatin is currently used to lower     blood cholesterol levels and lab data suggests that it increases the anti-leukemia activity     of cytarabine. This research is being done because high doses of cytarabine induce remissions     in only about 25% of patients with acute myeloid leukemia.   "
208697|NCT00583115|"     The purpose of this study is to find out if the drug, Gleevec, is safe and effective in     treating children with Pulmonary Hypertension.   "
208698|NCT00583128|"     The objective of this study is to evaluate the safety and effectiveness of the experimental     drug AST-120 in treating patients with non-constipating IBS. The study will test whether or     not patients receiving AST-120 experience at least a 50% reduction in the number of days with     abdominal pain compared to placebo.   "
208699|NCT00583154|"     To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated     adults.   "
208700|NCT00583167|"     Understanding whether or not viral replication occurs in the brain during chronic untreated     HIV-1 infection is of undeniable importance, and has implications for treatment and research     priorities. Evidence suggests that viral replication in the CNS occurs at the extremes of     HIV-1 disease. Brain involvement has been reported during acute infection, and there is     convincing evidence of CNS viral replication during HIV-associated dementia (HAD) and     advanced AIDS. Some human and primate data suggest that viral RNA and proteins may be absent     from brains of some individuals with chronic untreated HIV-1 infection despite abundant     proviral DNA. However, the extent of viral replication in the brain is not known for most of     the 42 million people worldwide living with untreated HIV-1 infection.      Why is viral replication in the brain such a pivotal issue? Microglial cells and macrophages     are primary targets for intrathecal HIV-1 replication, and this can promote neuronal injury     through direct effects of gp120 and tat, and indirect induction of toxic mediators. Low-grade     injury over years or decades would likely be deleterious, particularly as the population     ages. Because treatment guidelines allow systemic HIV-1 replication to continue until CD4+ T     cell counts decline considerably, antiretroviral therapy (ART) is not recommended for many     persons living with HIV. Demonstrating replication in the brain during chronic HIV-1     infection may affect treatment strategies and encourage investigation.      Identifying factors that modulate intrathecal viral replication is equally important.     Anti-HIV-1 cytotoxic T lymphocytes (CTL) partially control systemic viral replication and     delay disease progression. Although available data has been provocative, the role of anti-HIV     CTL in the CNS has received little attention. To fill this gap we will examine relationships     between intrathecal viral replication, CTL responses, and glial activation/proliferation     during HIV-1 infection. These studies will be relevant not only to AIDS but to other     inflammatory diseases of the CNS as well.   "
208701|NCT00583180|"     The use of capsaicin as a potential analgesic drug for postoperative pain relies on the     ability of capsaicin to induce membrane lysis of c-nerve fibers. In a previous randomized     placebo controled blinded study of this effect we found a significant effect of capsaicin     versus placebo. Before surgery all patients were examined by quantitative sensory testing to     evaluate sensory function. In this study an identical sensory testing will examine if changes     to the sensory function in capsaicin treated patients is identical to placebo treated     patients.No new intervention will be performed   "
208702|NCT00583193|"     The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective     treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).   "
208703|NCT00583206|"     Severe sepsis will provoke signals leading to muscle atrophy and weakness. Electrical     stimulation will reduce the impact of sepsis.   "
208704|NCT00583219|"     The primary objective of this pilot study is to evaluate the safety and efficacy of direct     instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of     treating women with symptoms of overactive bladder and secondary urinary incontinence. In     doing so, we will focus on estimating the percentage of women who experience an improvement     in their urinary incontinence symptoms at one month and three months following this novel     instillation technique.   "
208716|NCT00583375|"     STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the gold     standard (ABG) in a representative clinical model (hindfoot and ankle fusions)      STUDY HYPOTHESIS: GEM OS™1 is an equivalent bone grafting substitute to autologous bone graft     in applications as shown by non-inferiority analysis      STUDY RATIONALE: Evaluate a fully synthetic growth-factor enhanced bone graft substitute to     facilitate fusion in conditions or injuries requiring bone graft in a representative clinical     fusion model and thus the opportunity to provide equivalent union rates as ABG without     necessitating an additional invasive procedure to harvest the graft      REGULATORY PHASE: Investigational Device Exemption (IDE) for Premarket Approval (PMA)     Application as a bone regeneration system, pivotal phase   "
208734|NCT00583609|"     To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently     treated with PEG3350 powder for treatment of constipation.   "
208736|NCT00583635|"     Use of Juice Plus+ food supplements, when initiated in the first trimester and used     continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy     complications. This is a prospective randomized and blinded placebo controlled study     sponsored by NSA, LLC of Memphis, TN.   "
208737|NCT00583648|"     The implementation of nursing urinanlysis protocols based off of symptoms of urinary     infections will significantly decrease the length of a patient's stay in the Emergency     Department.   "
208738|NCT00583661|"     The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric     Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance     of safety and probable benefit such that the EXCOR® Pediatric merits approval by the Food and     Drug Administration under a Humanitarian Device Exception (HDE).   "
208705|NCT00583232|"     The metabolic response to Crohn's disease, including increased proteolysis and lipolysis and     changes in energy expenditure, plays a significant role in the resulting malnutrition from     which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory     cytokine, has been found to be elevated in children with ulcerative colitis. TNF-alpha has     been incriminated in the mechanism of weight loss in many different chronic diseases, and     causes net protein and lipid catabolism. Anti-TNF-alpha antibody (infliximab) has been proven     to be an effective therapy for ulcerative colitis.      The purpose of this study is to compare changes in protein and lipid metabolism, as well as     resting energy expenditure, before and after therapy with anti-TNF-alpha antibody     (infliximab) or corticosteroids in children with recurrent Crohn's disease. Performing this     study will better define the changes in nutrition status observed in these children following     remission of active Crohn's disease, and potentially lead to changes in medical and     nutritional management of these children.   "
208706|NCT00583245|"     Knee osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is     one of the most disabling problems facing the growing population of older adults. The     long-term objective of this research is to reduce disablement of older adults with     symptomatic knee OA. The principle of specificity of training indicates that exercises that     closely approximate the goal functional activity are most effective in improving physical     performance during that activity. Based on this principle, the specific aim of this pilot     study is to design a patient-specific gait training intervention using analysis of     compensatory joint moments and energy expenditure. Successful completion will inform     rehabilitation for maintaining or improving mobility as well as explore the mechanism of     effect.   "
208707|NCT00583258|"     Patients who present for the first time to Emergency Room with renal colic due to a distal     ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive     Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study     is to assess if patients treated with Xatral will have a higher spontaneous passage rate of     their ureteral stone than those treated with placebo.   "
208708|NCT00583271|"     The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided     CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are     already undergoing celiac block for clinical reasons.   "
208709|NCT00583284|"     Patients with ventricular tachycardia (VT) undergo catheter ablation. During the ablation     procedure, the heart is mapped to determine areas of heart muscle damage. The heart scarring     areas are often the source of the VT. Delayed enhancement CT has recently been used to     determine areas of scarring . This study is to determine if the areas of damaged heart muscle     mapped with the delayed enhancement CT correlate with the same areas that are determined     during the catheter ablation.   "
208710|NCT00583297|"     The ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine     if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in     predicting life-threatening heart rhythms in patients with ischemic heart disease, left     ventricular dysfunction, and non-sustained tachycardia. The purpose of the ABCD Genetic     sub-study is to identify genetic markers that predict TWA status and arrhythmia risk in this     same population.   "
208711|NCT00583310|"     Individuals with prehypertension are at risk for developing cardiovascular disease and     sustained hypertension. Modifying lifestyle behaviors (diet, weight loss, sodium intake,     physical activity, alcohol intake) has been shown to reduce blood pressure in hypertensives.     Participants in this study will be enrolled in one of two groups. Participants in the first     group will receive usual care, and participants in the second group will receive a 4 session     telephone-based lifestyle intervention. The goal of the study is to determine whether this     intervention is effective in promoting behavior change and reducing blood pressure among     prehypertensives.   "
208712|NCT00583323|"     2-[18F]-fluoro-2-deoxyD-glucose positron emission tomography (FDG PET) has proven to be a     valuable clinical tool for the staging and surveillance of lymphoma.1-6 Occasionally, lymph     nodes in the mesentery and retroperitoneum can be difficult to distinguish from normal bowel     activity on PET scans despite three-plane and cine maximal image projection (MIP) imaging.     This uncertainty limits the clinical usefulness of PET in some cases of lymphoma.7-8 In     addition, bowel activity can also hinder interpretation of PET scans in other types of solid     tumors including melanoma and colorectal cancer.6,9,10 Our goal is to determine how well     diphenoxylate/atropine 5mg/0.05mg (Lomotil) decreases bowel activity and how this decrease     impacts clinical decision-making, specifically for lymphoma staging and surveillance. This is     a prospective, randomized, double-blinded study involving 60 patients undergoing PET scans     for newly diagnosed or recurrent, untreated lymphoma.   "
208713|NCT00583336|"     ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be     used to detect no-flow in symptomatic patients with shunt obstruction.      Secondarily, the ShuntCheck test will yield the clearest results when patients are tested     sitting up (or alternatively while supine)   "
208714|NCT00583349|"     The intravesical treatment of bladder cancer with Abraxane is more desirable than other     taxanes due to its ability to be diluted in water and not lipid-based solutions allowing it     greater access to sites in the bladder. Thus, we are interested in investigating Abraxane's     safety, toxicity, and efficacy profile for the treatment of recurrent transitional cell     cancer of the urinary bladder in a combined phase I & II trial. The phase I trial is designed     as a dose-escalation study with cohorts of threes that will enroll a maximum of 18 patients.     Dose increases will occur in groups of three patients, with each successive group receiving     an increased concentration of Abraxane intravesically. No dose increase will occur until each     member of the previous cohort has undergone the first instillation of the medication without     experiencing a dose-limiting toxicity (DLT). Any patient who experiences a DLT will be     removed from the trial and treated appropriately.      If one patient in the cohort experiences a DLT an additional three patients will be enrolled     and treated at that dose-level. If none of the additional three patients experience a DLT,     the next group of patients will be started on the next higher dose level.      If at any dose level, two or more patients experience a DLT the previous dose level will be     considered as the maximum tolerated dose (MTD). An additional three patients (for a total of     six patients) will then be treated at the MTD. If less than two patients experience a DLT     this dose level will be established as the MTD. The phase II aspect is designed in a Simon II     stage format in which to satisfy our study powering, the first stage there will be 10     patients enrolled. If there are 2 or more successful treatments in that group (negative urine     cytology and bladder biopsy after 6 months), then the first stage will pass the rejection     rule, and up to another 19 patients will be enrolled. If at any point in the study, there     have been a total of 6 or more successes, then the phase II aspect will be considered a     successful trial and the study will be completed at that point.   "
208715|NCT00583362|"     This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™     in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.   "
220521|NCT00731068|"     To review the influence of patient derived PRGF on the healing process of Achilles tendon     after a surgical correction of a complete tear.   "
208717|NCT00583388|"     Acute cardiac and vascular events, like heart attack and sudden cardiac death manifest a     clear surge in the early morning hours around the time of waking, so that their peak onset is     between 6AM and 11AM. The mechanisms are not fully understood, but we had shown that healthy     subjects have impaired vascular reactivity in the early morning (endothelial dysfunction).     This is associated with a decrease in nitric oxide levels (a substance that promotes     vasodilatation). We also have described that vessel reactivity and the levels of this     substance can recover by noon only when people breakfast.      L-arginine is a semi-essential amino acid found in large quantities in chicken, in fish, and     beans and is the substrate for the production of nitric oxide Therefore we want to test if     there is a beneficial effect of administration of L-arginine on the circadian pattern of     vessel reactivity. Our goal is to understand why cardiovascular events are more likely to     happen in the early morning and how to prevent.      The research will help us to understand the efficacy, acute effects and tolerability of high     doses of L-arginine. This can lead to future research to assess long term effects of     L-arginine supplements to prevent cardiovascular events in the early morning hours.   "
208718|NCT00583401|"     Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least     two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale     and who have failed conventional therapy.   "
208719|NCT00583414|"     The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm     exclusion using an endovascular prosthesis.   "
208720|NCT00583427|"     The purpose of this study is to see if a medicine called Sulodexide will help prevent or slow     down the progression of Membranoproliferative Glomerulonephritis type II/Dense Deposit     Disease. Sulodexide is not yet FDA approved and has not been studied in children.      Study aim/hypotheses: to measure the efficacy of Sulodexide treatment in patients with the     above disease/s.   "
208721|NCT00583440|"     This is a randomized trial testing the efficacy of a modified 12-step facilitation therapy     for individuals with serious mental illness and alcohol use disorders, compared to usual     treatment. 135 participants are randomized in 2:1 ratio to the modified 12-step facilitation     (12 sessions of individual counseling) vs. treatment as usual. The primary hypothesis is that     those receiving 12-step facilitation will have better drinking outcomes (percent days     abstinence and drinks per drinking day)at end of treatment.   "
208722|NCT00583453|"     The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces     post-operative narcotic use.      To test this hypothesis, the study is placebo controlled (sugar pill). Half of the     participants will receive a sugar pill, half will not.      All participants will receive the standard post-operative pain medications.      We ask participants to log the amount of medications they use daily, and the amount of pain     they have each day. It is hoped that celecoxib will reduce the amount of post-operative pain     medication needed.   "
208723|NCT00583466|"     For removal of large flat lesions of the gastro-intestinal tract injection of a solution     under the lesion creates a safety cushion and protects from damage to the gastrointestinal     tract wall. Various solutions are currently used, but some of them are easy to inject but     quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl     methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive     and not always available. We decided to use blood drawn from the patient for injection under     the lesion. We performed previously animal experiments which demonstrated that blood is easy     to inject and creates a protective cushion which lasts longer than other fluids which are     currently used for protective cushion creation.   "
208724|NCT00583479|"     The purpose of this prospective randomized study is to compare the clinical effectiveness of     EUS-guided CB performed with a single injection versus two injections of medication into the     celiac ganglion region.   "
208725|NCT00583492|"     This is a randomized, controlled trial that will test the hypothesis that     replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy     intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80     Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk     profile.   "
208726|NCT00583505|"     Emergency/Compassionate use of the AMPLATZER Membranous VSD Occluder   "
208727|NCT00583518|"     The primary objective of the study is to explore the relationship between a new image     technology (ImaTx), that analyzes the trabecular structure of the bone using digitized     radiographs and the bone mineral density (BMD) measured by Dual X-ray Absorptiometry (DXA) in     the lumbar spine of postmenopausal (PM) women with osteoporosis (OP) after treatment with PTH     (1-84).   "
208728|NCT00583531|"     This is an open-label pilot study in which all patients will receive AST-120 for 4 weeks.     Patients will discontinue antibiotics at study entry. They may continue other previously     prescribed treatments (e.g., probiotics and/or nutritional agents) at the discretion of the     study doctor. The purpose of the study is to assess whether the investigational medication     AST-120 will be a safe and effective treatment for the symptoms of pouchitis, a chronic     inflammatory condition, in patients whose symptoms have not responded well to antibiotics. An     initial group of 10 patients will be enrolled. If there are no serious side effects     associated with the study drug and at least 3 of the 10 patients respond, a second group of     10 patients may be enrolled. Patients will have clinic visits at the start of the study and     at week 4. Patients will be checked by phone on a weekly basis for symptom response,     compliance and development of side effects. Endoscopies will be performed at the start of the     study and at week 4 or early termination.   "
208729|NCT00583544|"     Targacept, Inc. is studying TC-2216 for a potential role in the treatment of central nervous     system (CNS) neurobiological disorders in anticipation of seeking an indication in depression     and/or anxiety.   "
208730|NCT00583557|"     This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects     with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.   "
208731|NCT00583570|"     Specific Aim: To determine the effect of a phosphorus additives educational intervention on     serum phosphorus levels.      Hypothesis: Educating dialysis patients regarding phosphate containing additives will result     in improved serum phosphorus levels.   "
208732|NCT00583583|"     Emergency/compassionate use for the AMPLATZER Duct Occluder   "
220522|NCT00731081|"     To describe severe late onset patients with pompe disease receiving Myozyme®   "
208739|NCT00583674|"     This is a phase 2, randomized, double blind, placebo controlled, multi-center study to     estimate the improvement in progression free survival (compared to control subjects) and     evaluate the safety and tolerability of AMG 386 in combination with Cisplatin & Capecitabine     in the treatment of subjects with Metastatic Gastric, Gastroesophageal Junction, or Distal     Esophageal Adenocarcinoma. AMG 386 is a man-made medication that is designed to stop the     development of blood vessels in cancer tissues. Cancer tissues rely on the development of new     blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to     grow.   "
208740|NCT00583687|"     The purpose of this study is to compare changes of minimally invasive arterial pulse contour     cardiac output with changes of intermittent and continuous thermodilution cardiac output by     pulmonary artery catheter in hemodynamic unstable patients with rapid changing vascular tone     (changing dosage of vasoactive drugs or inotropics, or volume challenge). Simultaneously,     global parameters of oxygen delivery and consumption will be compared with regional flow     parameters and tissue oxymetry (near infrared spectrometry and laser-Doppler). While     continuous thermodilution cardiac output is used for patient management, pulse contour     cardiac output, intermittent thermodilution cardiac output and tissue oxymetry is only used     for monitoring.   "
208741|NCT00583700|"     This study seeks to determine if a combination of Trental and Vitamin E prevents the     development of radiation fibrosis in women treated with radiation for the definitive     management of their breast cancer.   "
208742|NCT00583713|"     To evaluate and compare the effects on safety measures and clinical chemistry after BLI800 in     two groups of patients and one group of healthy controls. The patient groups will be those     with mild or moderate hepatic impairment or moderate renal disease.   "
208743|NCT00583726|"     This study aims to determine if a motivational interviewing counseling style can help women     eat a healthy diet and exercise during breast cancer treatment and beyond.   "
208744|NCT00583739|"     A randomized trial from the British National Health Service found that supervised exercise     benefits women with early stage breast cancer with improved functional and psychological     benefit after a 12-week intervention and 6 months later. Considering the needs of breast     cancer patients and survivors and the reported benefits of exercise and yoga intervention,     the investigators propose a pilot study of an 8-week yoga intervention in breast cancer     patients. This study would specifically address measures of fatigue and psychosocial distress     in the population of breast cancer patients during treatment and within the year following     treatment. Currently there is very limited literature on yoga intervention in this     population.   "
208745|NCT00583752|"     The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will     induce an anti-PSA immunity that will result in the destruction of the remaining prostate     cancer cells.   "
208746|NCT00583765|"     Dialysis requires thinning of the blood to prevent clotting in the dialysis machine. Thinning     of the blood is necessary but some forms of blood thinners may cause bleeding. Therefore,     researchers are seeking ways to minimize bleeding risks and ensure effective dialysis.      One medication used to thin the blood in the dialysis machine is citrate. Citrate has the     advantage of having its blood-thinning properties quickly reversed by calcium in the     patient's blood. As a consequence, only the blood in the machine is thinned, greatly reducing     the risk of bleeding when dialysis is carried out using other blood thinners. Until now, most     patients who received citrate for dialysis were administered the citrate in a separate     infusion through an IV pump into the dialysis machine. This method requires complex     monitoring and calculations. This study is about Prismocitrate which is a dialysis fluid very     similar to the regular dialysis fluid that is used in this intensive care unit, except that     this fluid already contains exactly the correct amount of citrate. Thus, this method does not     require a separate pump for citrate and calculations to pump the citrate into the blood as it     goes through the kidney machine. Having the citrate already contained in the dialysis fluid     simplifies the procedure and reduces the possibility of calculation errors.      This study seeks to determine if this simplified means of providing blood thinning in the     kidney machine also results in the correct balance of blood salts.   "
208747|NCT00583778|"     This is a double blind, controlled clinical trail testing whether three doses of 1.25 mg of     nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will     lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of     levalbuterol alone every 20 minutes.      The primary hypothesis of this study is that three doses of 1.25 mg of nebulized levalbuterol     in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater     bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone     every 20 minutes. The secondary hypothesis is that the treatment combination of levalbuterol     and ipratropium will lead to fewer hospitalizations than levalbuterol alone in patients with     acute asthma exacerbation. Other secondary objectives include (1) evaluating the relationship     between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and FEV1,     (2) the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on     presentation and change in FEV1,(3) time to event analysis for an improvement of 15%, 20%,     30%, 40%, and 50% in FEV1 from initial presentation value, (4) analysis of FEV1 at discharge.   "
208748|NCT00583791|"     The objective of this feasibility study is to investigate the safety of the AMPLATZER     Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are     hemodynamically significant and are either isolated or in conjunction with other congenital     heart defects in infants and children.   "
208749|NCT00583804|"     The purpose of this study is to evaluate the effectiveness of an implanted stimulator and     sensor for providing hand and arm function for individuals with cervical level spinal cord     injury.   "
208750|NCT00583817|"     The purpose of this study is to assess the role of ascending and/or aortic arch     aneurysm/dissections treatment using a novel endovascular prosthesis in high risk surgical     patients.   "
208751|NCT00583830|"     The purpose of this study is to evaluate the efficacy (disease response) and safety of     mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects     with advanced non-small cell lung cancer (NSCLC).   "
209160|NCT00588354|"     This was a randomized, blinded study of transforaminal epidural injection of clonidine versus     a similar injection of corticosteroid for acute lumbosacral radiculopathy. The hypothesis was     that clonidine will be as effective as steroid for this condition.   "
208752|NCT00583843|"     Accurate targeting of treatment sites should increase local control by radiation therapy for     breast-cancer lumpectomy patients. Currently, ultrasound localization is used for prostate     cancer patients to locate the prostate before daily radiation treatments. There is now     documented evidence that the lumpectomy site does change during the external radiation     therapy. Thus, treatment efficacy should be increased by localizing the target, monitoring     volume changes, and adjusting the radiation target prior to the boost radiation dose.   "
208753|NCT00583856|"     Investigator initial study to evaluate the use of preoperative computer modeling and the     intraoperative navigation to guide reconstruction of the maxillofacial skeleton.   "
208754|NCT00583869|"     This is a randomized, prospective, double-blind pilot study designed to evaluate the     potential effectiveness of pregabalin in post-operative pain management for patients who have     sustained a fracture.   "
208755|NCT00583882|"     This project proposes to answer the following questions:      To determine the incidence of infection with three primary schedules of central venous     catheter exchange in pediatric burn patients and to determine the regimen that will minimize     infectious risk in children with burns.      The scientific knowledge to be acquired through this project is of likely benefit to the care     of children with orthopaedic problems, spinal cord injuries or burns as follows:      The intention is to improve the outcomes in burned children by minimizing one of the most     frequent causes of infection in the burn intensive care unit, those from central venous     catheters. Decreasing infections will decrease morbidity, decrease length of stay, decrease     costs, and decrease mortality in burned children   "
208756|NCT00583895|"     Atopic dermatitis is one of the most common skin diseases, with a lifetime prevalence of up     to 20%, and an increasing number of cases. Although there are a variety of treatments the     number of specific medications for treating this chronic disease is limited and often not     helpful, especially in more severe cases. In addition,most treatments may be used only for a     limited period or are less effective in the long term (tachyphylaxis). The development of new     compounds is mandatory for treatment of this often chronically recurring disease. The current     trial will determine the efficacy, safety and tolerability of the endogenous compound     imidazole-4-carboxylic acid (ImCOOH) administered as a topical cream twice daily for 14 days     in patients with atopic dermatitis.   "
208757|NCT00583908|"     The purpose of this study is to determine the relative performance of a new toric soft     contact lens against three toric contact lens currently available in market, specifically     with orientation and visual acuity when head is tilted at 90 degrees.   "
208758|NCT00583921|"     Single center investigator initiated sponsored by Guidant Boston Scientific Corp. to evaluate     the benefit of ventricular rate regularization (VRR) in patients with congestive heart     failure (CHF) and significant atrial fibrillation (AF) burden.   "
208759|NCT00583934|"     The purpose of this study is to evaluate the prevalence of esophageal pathology in     asymptomatic patients with a history of head and neck cancer.   "
208760|NCT00583947|"     To determine the safety and tolerability of Arformoterol Tartrate in children with asthma   "
208761|NCT00583960|"     Retrospective chart review of UCDMC patients who have undergone esophageal or tracheal     balloon dilation to record data including age, gender, diagnosis pre-and post-procedure     eating assessment tool, esophagoscopy findings, tracheobronchoscopy findings, and pre-and     post-procedure videofluoroscopic findings.   "
208762|NCT00583973|"     Parenteral iron therapy is now commonly administered to dialysis patients with the majority     of patients receiving this therapy as part of the treatment for their anemia. Although     intravenous iron has improved clinical response to recombinant erythropoietin, there is a     concern that iron therapy may have deleterious effects in Chronic Kidney Disease (CKD)     patients. Iron can damage tissues by catalyzing the conversion of hydrogen peroxide to     free-radical ions that attack cellular proteins, DNA and membranes as part of oxidative     stress. Numerous in vitro studies have shown tissue toxicity from iron and increased     infectious potential. Oxidative stress can also lead to activation of the systemic     inflammatory response with the release of a number of key cytokines and growth factors. There     is now a link between inflammation, oxidative stress and acceleration of vascular disease in     both patients with normal as well as reduced renal function. In a study comparing normal     versus low hematocrit levels in hemodialysis patients, mortality was higher in the normal     hematocrit group. The major difference between the two groups has been attributed to the fact     that patients in the normal hematocrit group received significantly more iron than the     patients with low hematocrit. There was a 2.4 fold greater mortality rate in patients     receiving parenteral iron.      The effect of parenteral iron administration on activation of the systemic inflammatory     response in hemodialysis patients has not been evaluated. The purpose of this study is to     measure a number of key cytokines, inflammatory and oxidative stress markers in hemodialysis     patients receiving iron repletion therapy as part of their standard care.   "
208763|NCT00583986|"     This is a study to investigate the reliability, ruggedness and safety of the top mounted     actuation indicator (TMAI) when used with Levalbuterol HFA MDI.   "
208781|NCT00584220|"     The purpose of this study is to determine the relative performance of a new toric soft     contact lens against a toric contact lens currently available in market, specifically with     regards to the comfort and vision after two weeks of use.   "
221490|NCT00743860|"     This study is designed to assess the pharmacokinetics of darapladib and its metabolites     following single and 28 days of repeat dosing of darapladib.   "
208764|NCT00583999|"     NAFLD is a spectrum of liver diseases associated with varying degrees of hepatic steatosis,     inflammation, and in some cases, fibrosis. NAFLD is a common observation in all demographics,     but the prevalence of NAFLD and nonalcoholic steatohepatitis (NASH) is especially high in the     morbidly obese population. Leptin is a cytokine that is encoded by the ob gene and primarily     secreted by adipose tissue. The production of serum leptin increases with progressive     obesity. Because of this observation, there has been significant interest in potential role     of leptin in NAFLD.      Our hypothesis is that we will find increased hepatic leptin and leptin receptor expression     as the degree of hepatic injury worsens in NAFLD.   "
209184|NCT00588679|"     The purpose of this study is to determine the benefits of Magnetic Resonance Imaging (MRI)     combined with Magnetic Resonance Spectroscopic Imaging (MRSI), on an instrument called a 3.0     Tesla (T) MR scanner.   "
208765|NCT00584012|"     This purpose of this study is to evaluate the use of two medications, docetaxel and     lovastatin. There are two phases. Subjects in Phase I can have any cancer. This phase will     determine the highest dose of lovastatin and docetaxel that can be given safely as well as     the safety of combining the two drugs and the effect on the subject's tumor. Phase II will     administer lovastatin and docetaxel only to subjects who have breast cancer tumors.   "
208766|NCT00584025|"     The primary purpose of this study is to characterize the acute anti-dyskinetic properties of     intravenous levetiracetam in Parkinson's disease patients who have been optimized on     antiparkinsonian medication. The secondary objective is to study the effect of intravenous     LEV on additional motor and cognitive symptoms of PD.   "
208767|NCT00584038|"     The purpose of this study is to determine whether contraceptive compliance by young women can     be improved through expanded counseling by a health educator at the initial clinic visit as     compared with standard care.   "
208768|NCT00584051|"     Asthma is an inflammatory condition of the airways in the lungs that results in obstruction     of airflow in those with the condition. The disease continues to be a major worldwide health     care problem and its prevalence continues to increase annually. In 2005, 20 million people     were diagnosed with asthma. The disease causes significant morbidity and accounts for 5,000     deaths annually. Between 1980 and 1994 the prevalence of asthma increased 74% in the United     States and, in children under age 5, the prevalence increased by 160%. The allergic etiology     of airway inflammation associated with asthma is established. Bronchial washings of asthmatic     subjects are most often characterized by eosinophils, mast cells, and cytokines that are     associated with the Th2 (allergic) phenotype. Similarly, IgE plays a pivotal role in airway     inflammation of asthmatic subjects when allergens that cross-link IgE bound to mast cells in     the airways cause the release of histamine and other inflammatory mediators. The association     of asthma and the IgE mediated allergic phenotype is well established and up to 70% of     asthmatics also suffer from allergic disease.      Adequately treated asthma often has minimal impact of quality of life but diagnosis and     proper treatment is often delayed, resulting in increased missed school days, emergency room     visits, and otherwise preventable degradation in quality of life. It would therefore be     highly useful to identify a biomarker that can be used to assist in the diagnosis of asthma     or to identify subjects at higher risk of developing allergic disease or asthma in the     future. Efforts at identifying a genetic marker for the early diagnosis of asthma have been     unsuccessful, mainly due to the complexity of the pathogenesis of the disease.      Atrial natriuretic factor is a pro-hormone precursor for 4 natriuretic peptide hormones     including atrial natriuretic peptide (ANP). ANP's effects on the cardiovascular system are     well characterized. Less well understood is the role these hormones play in immune     regulation.      Recent studies have demonstrated a role for ANP in the regulation of immune function: ANP     induces release of histamine from mast cells and macrophages, stimulates migration of     neutrophils, enhances the cytotoxic activity of natural killer (NK) cells, and stimulates     TNF-β production. Human dendritic cells express ANP receptors (GC-a) which polarize CD4+     cells towards a Th2 phenotype.      Since allergic rhinitis and asthma are associated with a Th2 phenotype, it is possible that     elevated levels of ANP can be used to predict asthma severity or to predict future     predilection to atopic disease.      There are a number of ANP gene polymorphisms that have been studied and found to be     associated with renal disease, heart disease, hypertension and diabetes. Several studies have     investigated the potential role of these polymorphisms in cardiovascular disease and have     found association between polymorphisms of the ANP gene and left ventricular remodeling,     hypertension, renal disease, diabetes, and increased risk of ischemic stroke. To our     knowledge, no studies evaluating the role of ANP polymorphisms in allergic disease have been     performed.      The goal of this research proposal is to evaluate whether ANP levels can be utilized to     assist in diagnosis of asthma and in the prediction of asthma severity. Additionally, we will     investigate the potential effect of polymorphisms in the ANP gene on asthma severity and thus     serve as a useful genetic marker to predict future risk of atopy and asthma.   "
208769|NCT00584064|"     Emergency/compassionate use for the AMPLATZER PFO Occluder   "
208770|NCT00584077|"     The purpose of this study is to evaluate the presence of cough reflex in the transplanted     lung of patients who have had either a single or double lung transplant or heart-lung     transplant at University of Texas Medical Branch. At the 1 year post transplant bronchoscopy,     the presence of the cough reflex will be assessed by placing 3 to 5 ml of 5% dextrose and     placement of the bronchial biopsy forceps on teh airway mucosa. Three to four separate areas     of the transplanted airways will be assessed. The cough reflex will be assessed by recording     the surface electrical activity by placing external electrodes to monitor the movement of     abdominal muscles during a cough. The data will be recorded and compared with recordings from     coughs recorded using the surface electrical activity of a cough generated by non-transplant     patients.   "
208771|NCT00584090|"     The primary purpose of this study is to measure the efficacy of solifenacin succinate     (VESIcare) on treating urinary incontinence in Parkinson's disease patients.      The secondary objective of this study is to examine the effect of solifenacin succinate     (VESIcare) on symptoms of PD and the patient's quality of life.   "
208772|NCT00584103|"     The purpose of this study is to evaluate a design of prosthesis that is inexpensive and able     to fit a multitude of individuals. This may offer an off the shelf item for those that cannot     afford a customized prosthesis, or wish to have an inexpensive spare.   "
208773|NCT00584116|"     Prospective, two academic center, non-randomized pilot, acute in-patient study correlating     pre-operative imaging studies, intra-operative measurements and intra-operative balloon     aortic valvuloplasty (BAV) in patients with degenerative aortic stenosis undergoing surgical     aortic valve replacement (SAVR) to understand the requirements (device size and radial     strength) of emerging percutaneous heart valve technologies in the treatment of aortic     stenosis.   "
208774|NCT00584129|"     The purpose of this project is to determine if pre-treatment swallowing exercises can improve     post-treatment swallowing function in patients undergoing radiation with or without     chemotherapy for advanced squamous cell carcinoma of the head and neck.   "
208775|NCT00584142|"     The purpose of this study was two-fold: (i) to assess whether MBSR favorably influences     psychological status, quality of life, stress hormones, and immune status in breast cancer     survivors; and (ii) to explore possible mechanisms by which MBSR may favorably influence     these outcomes, in particular, through reduction in fear of breast cancer recurrence and     associated perceived stress. Both objectives were studied at the critical transition time     immediately following completion of surgical, radiation and/or chemotherapy therapy for     breast cancer.   "
208776|NCT00584155|"     The purpose of this study is to determine if Lactated Ringer's solution is effective in     patients undergoing chemotherapy with cisplatin for head and neck cancer in regards to     cisplatin-induced hearing loss.   "
208777|NCT00584168|"     This study looks at lessening the pain after a Uvulopalatopharyngoplasty (UPPP) surgery by     using Dexamethasone (a corticosteroid).   "
208778|NCT00584181|"     Lung and heart-lung recipients at the University of Texas Medical Branch who have     participated in the Assessment of Cough Reflex in Lung Transplant Recipients study who meet     the specific study inclusion/exclusion criteria will have one study visit where they will     undergo lung volume measurements, followed by high resolution CT scan of the lungs within 2     hours. After the initial CT scan, patients will be given a standard dose of Atrovent,     followed thirty minutes later by repeat lung volume measurements and CT scan.   "
208779|NCT00584194|"     This study is designed to determine the safety and immunogenicity of a Rift Valley Fever     (RVF) Vaccine   "
208780|NCT00584207|"     This research study is being conducted to evaluate the safety and effectiveness of ablation     (destruction) of uterine leiomyomas (fibroids) using electrocautery heating guided by     ultrasound. We are doing this to look for a less invasive method of treatment for patients     with uterine fibroids. One method that is being used in other areas of the body to treat     masses is radiofrequency electrocautery. This method may be performed for the treatment of     uterine fibroids by placing a small diameter needle through the wall of the vagina into the     fibroid guided by an ultrasound probe. An optional approach is to place the needle through     the skin of the abdomen into the fibroid guided by an ultrasound probe. Once the needle is in     the fibroid, the electrocautery current is applied and the fibroid is destroyed by heating.     This would be done before hysterectomy (removal of the uterus). We are trying to test to see     if this type of treatment can be applied to uterine fibroids. We are trying to develop     radiofrequency electrocautery as one of the methods to treat fibroids without surgery.   "
209828|NCT00599118|"     The purpose of this study is to establish a genebank repository of blood samples and data to     generate information about the hereditary (genetic) basis of atrial fibrillation.   "
208836|NCT00584935|"     Cicatricial pemphigoid is an autoimmune blistering disease which affects the skin, mucous     membranes, and, in a small subset of patients, the eye. Progressive ocular disease can lead     to irreversible damage and blindness. Conventional treatments include systemic steroids,     dapsone, and immunosuppressive agents. These treatments, however, are not successful with all     patients. Ritumimab has been very effective in the treatment of other autoimmune disorders,     and has recently been shown to be effective for autoimmune blistering pemphigus. We propose     that it will also be effective in the treatment of cicatricial pemphigoid.   "
208782|NCT00584233|"     The investigators have studied the potential of breast computed tomography (bCT) for breast     imaging under an NIH-funded Biomedical Research Partnership (BRP) grant (R01 EB002138-10),     and 4 breast CT scanners have been developed that have imaged over 600 women to date (under     more than one IRB-approved protocol). The BRP grant cannot be renewed, and with this     (resubmitted) R01 grant application, the investigators seek to finalize the investigators'     research in breast CT - The specific aims have been significantly modified as a result of the     first critique, and the investigators now focus on a narrower set of remaining issues.      This version of the protocol will add breast magnetic resonance imaging (MRI) to the     experimental procedures.   "
208783|NCT00584246|"     This study will evaluate the safety and efficacy of Pregabalin (Lyrica) in treating patients     with Restless Legs Syndrome (RLS) in a double-blind, placebo-controlled trial.   "
208784|NCT00584259|"     Investigation evaluating the effect of coffee on gastro-esophageal reflux disease.   "
208785|NCT00584272|"     Investigator initiated retrospective chart review to study the effects of changing suture     material on the healing and outcome of cleft palate surgery were.   "
208786|NCT00584285|"     The objective of this study is to determine if corneal topography can be used to predict the     fluorescein pattern of keratoconus lenses on the eye. A corneal topography image will be     taken and the computer selected lens will be placed on the eye. After placement of the lens     color photographs will be taken of the eye's fluorescein pattern and compared to the computer     predicted pattern.   "
208787|NCT00584298|"     This study is designed to provide information on feasibility and reproducibility of barostat     assessments of colorectal sensory functions and compliance and their pharmacological     modulation   "
208788|NCT00584311|"     Radiographic imaging plays a key role in managing the long-term effects of hyperuricemia on     the skeletal system. Two of the accepted indications for prophylactic urate-lowering drugs in     patients with hyperuricemia are gouty tophi and erosions. While much data exist on the plain     radiographic changes that are seen in patients with chronic gout, far less is known about the     changes seen on other imaging modalities, such as magnetic resonance imaging (MRI) and     ultrasound (US). Further, there is very little data on the MRI and US appearance of     asymptomatic joints in patients with hyperuricemia and symptomatic gout.      There is vast emerging data to suggest that MRI and US are much more sensitive than plain     radiographs at detecting the early stigmata of rheumatoid arthritis (RA). Indeed, these     imaging devices have revolutionized the treatment of RA, for the earlier detection of the     skeletal changes of RA often mandates more aggressive therapy. These same changes would often     be missed by plain radiographs.      It is our hypothesis that MR imaging and US will detect the skeletal changes that are typical     of gout much sooner than would plain radiography. We also hypothesize that these same imaging     techniques will be able to detect signs of hyperuricemic silent deposition in asymptomatic     joints of patients with symptomatic gout in other joints. As was the case with RA, the     expected results of this study would mandate more aggressive therapy of both gout and     hyperuricemia.      Our primary aim of this proposal would be accomplished by studying patients with known gout     and normal plain radiographs. Each patient would have their most frequently involved joint     (index joint) analyzed by MRI and US to evaluate for any destructive changes (erosions or     tophi with cortical damage). Any signs that may portend future joint destruction such as     synovial pannus, bone marrow edema, soft tissue edema, or joint effusions will also be     documented. In order to demonstrate the effects of hyperuricemic silent deposition, an     asymptomatic joint from these same patients will be studied using these same imaging     techniques. Any evidence of erosions, tophi, synovial pannus, bone marrow or soft tissue     edema, or joint effusions will be recorded. By demonstrating destructive, or potentially     destructive, skeletal changes in the index joint or asymptomatic joint of a significant     number of patients, we will show that patients who are left untreated on the basis of normal     plain radiographs are likely to already have skeletal damage.   "
208789|NCT00584324|"     Purpose of this study is to see if different levels of anesthesia have an effect on hearing     spoken words without awareness of having heard them or anxiety after surgery.   "
208790|NCT00584337|"     This study is designed to evaluate a new approach to the diagnosis of chronic or sub-acute     chest pain patients in the out-patient setting. Patients in this study are selected to be     low-risk, meaning they are not having an acute or recent heart attack (AMI), based on     screening blood tests and electrocardiograms (EKGs). In addition, these patients have a low     or intermediate pre-test likelihood of the coronary artery disease (CAD), which means that     probability of the CAD based on the available clinical and historical information, does not     make a diagnosis of the CAD a certain clinical diagnosis in the particular patient and this,     in turn, requires an additional diagnostic work up.   "
208791|NCT00584350|"     The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation     with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic     coronary angiogram or to PCI.   "
208792|NCT00584363|"     The purpose of the study is to collect pancreatic tissue, blood and urine from adults to     study pancreatic abnormalities.   "
208793|NCT00584376|"     This will be a multi-site, prospective, double-blind, randomized, placebo-controlled,     crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to     treat symptoms of ET.   "
208794|NCT00584389|"     This study will determine in obese subjects the direct effects of the weight loss drug     rimonabant (ie independent of weight loss) on energy expenditure, fat metabolism and and body     fat distribution. We hypothesise that rimonabant will increase energy expenditure. The fuel     for the increased energy expenditure will come from fat. As a result of burning more fat     there will be a decrease in fat in blood and an improvement in the body's response to     insulin.   "
208795|NCT00584402|"     The purpose of this study is to determine the efficacy of the Definity (perflutren lipid     microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors     (hepatomas & metastases) within the liver.      Primary objective: To estimate the increase in conspicuity of small intrahepatic tumors with     contrast-enhanced sonography      Secondary Objectives: To estimate the effect of tumor type, size, location and depth on the     conspicuity of small tumors on contrast-enhanced sonography   "
208796|NCT00584415|"     The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be     used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation     in patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial     fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.   "
208797|NCT00584428|"     To evaluate the response rate and the response duration of high dose chemotherapy with     autologous bone marrow transplantation as intensification following induction chemotherapy in     metastatic breast cancer and to evaluate prospectively the subdivision of patients with     metastatic breast cancer according to prognostic groups.   "
208814|NCT00584649|"     Hypothesis- Radiofrequency ablation, targeting the sympathetic input of the sinus node     identified by 20Hz stimulation at the junction of the superior vena cava and the right     atrium, will effectively reduce sinus rate acutely and will reduce palpitations due to     inappropriate sinus tachycardia without the need for pacemaker implantation due to sinus node     dysfunction post ablation.   "
208798|NCT00584441|"     Asthma is a chronic inflammatory lung disease characterized by airway hyper-responsiveness     and reversible airway obstruction. Over the last decade, the prevalence of asthma is on the     rise and it disproportionately affects more women than men. As much as 40% of women with     asthma are known to have worsening of asthma symptoms and lung function prior to     menstruation. This syndrome is being increasingly recognized as premenstrual asthma (PMA).     The pathologic differences in female asthmatics with and without this syndrome are not known.     The evidence regarding the role of sex hormones has been contradicting. We propose an     observational cohort study to examine the changes in airway inflammation in women with asthma     in relation to their menstrual cycle and their association with sex hormone levels. In     addition we will include women on oral contraceptives to determine their effect on airway     inflammation and asthma symptoms.      We hypothesis that:        -  Women with premenstrual asthma will show increased indices of airway inflammation in          various phases the monthly menstrual cycle.        -  In women with premenstrual asthma, a change in serum estradiol/progesterone ratio during          the late luteal phase is associated with worsening of airway inflammation, air flow          limitation and asthma symptoms.        -  The use of oral contraceptives is associated with suppression of the cyclical changes in          airway inflammation due to lack of fluctuations in estradiol and progesterone levels.      Recruited subjects will be asked to record asthma symptom scores, morning Peak Expiratory     Flow Rate (m-PEFR) and rescue asthma medication (β2-agonist) used daily during the one month     screening period to identify women with and without pre-menstrual asthma. Asthmatic women     with regular menstrual cycles will be evaluated in their follicular phase (days 5-8) and     luteal phase (days 21-24) and women on oral contraceptive pills (OCP) will be evaluated on     days 9-12 of their OCP cycle and during the days 25-28, off of OCP consecutively for a     2-month period.   "
208799|NCT00584454|"     The purpose of this study is to evaluate the safety of Q Fever vaccine, NDBR 105, and collect     data on incidence of occupational Q Fever infection in at risk personnel.   "
208800|NCT00584467|"     This is an investigator initiated registry aimed at assembling a blood/serum and genomic     resource (bank) of human blood samples with accompanying clinical data mainly from patients     who are scheduled to undergo cardiac catheterization at UC Davis Medical Center, but may also     include other eligible individuals. Funding is from institutional/divisional research funds.   "
208801|NCT00584480|"     The purpose of this study is to increase the understanding of the effect of Hyperbaric Oxygen     Treatment (HBOT) on the behavior and functioning of children with autism. The main goal of     this study is to demonstrate that HBOT is safe and tolerable in autistic children, and to     measure the effect of HBOT on specific chemicals in their blood that may play a role in the     child's behavior.   "
208802|NCT00584493|"     The purpose of this study is to provide access to CP-675,206 for patients with advanced     unresectable melanoma and who have the potential to gain benefit from this treatment and who     are not eligible for participation in other CP-675,206 studies.   "
208803|NCT00584506|"     A retrospective review to assess the performance and clinical predictive value of a novel     software program (Maxillo) designed to perform complex volumetric analysis with application     in the field of orbital trauma.   "
208804|NCT00584519|"     To analyse the progress of modifiable metabolic risk factors (Blood pressure, cigarette     smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with     overweight for 12 months.      To analyse the perceived health status and the level of functioning and disability of     patients with schizophrenia and overweight and their progress at 3, 6 and 12 months.      To assess the progress of the symptoms of the disease at 6 and 12 months.   "
208805|NCT00584532|"     Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent     in the treatment of localized prostate cancer.   "
208806|NCT00584545|"     To validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on     fluoroscopy by comparing it with simultaneous pharyngeal manometry.   "
208807|NCT00584558|"     The purpose of this study is to assess the long-term effects of catheter ablation procedures     performed at the OU Medical Center.   "
208808|NCT00584571|"     Constipation is a common digestive disorder. After excluding dietary factors, drugs and other     secondary causes, at least three broad pathophysiologic subtypes are recognized- dyssynergic     defecation, constipation-predominant irritable bowel syndrome (IBS-C) and slow transit     constipation (STC), all predominantly affect women and elderly. Many patients also     demonstrate abnormal rectal perception with both rectal hyposensitivity and hypersensitivity     being common. Recent surveys show that most constipated patients are dissatisfied with     current therapy. Also, constipated patients showed significant psychological dysfunction and     impaired quality of life. OBJECTIVE: To investigate a novel biofeedback technique of     improving rectal hypersensitivity.      METHODS: A large compliant balloon attached to a barostat was placed in the rectum in 8     patients with rectal hypersensitivity (urgency/pain threshold <30 mm Hg). Sensory     deconditioning was performed by incremental balloon distensions (1-2 mmHg) until normal     thresholds were reached.   "
208809|NCT00584584|"     This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal     antibody) gives protection against a model of hayfever   "
208810|NCT00584597|"     The specific aim of this study will be to determine the safety of TRAUMEEL S for mucositis in     head and neck cancer patients undergoing radiation therapy.   "
208811|NCT00584610|"     This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing     intrauterine device (LNG IUD, Mirena®) versus a copper IUD (Paraguard®) on coagulation     parameters known to be associated with risk of thrombosis (blood clots). Both the LNG IUD and     the copper IUD are FDA approved devices for contraception.      Women enrolled in this study will be randomized to receive either the LNG IUD or the copper     IUD. They will complete a one month bleeding diary prior to insertion of the IUD and again     for one month while the IUD is in place. They will undergo phlebotomy (blood draw) at     baseline (prior to insertion of the IUD), two and four months. Stored samples will be used to     measure D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIIIc, activated partial     thromboplastin time (aPTT) and activated partial thromboplastin time plus activated protein C     (aPTT + APC). Both groups will undergo a GYN exam with screening for bacterial vaginosis and     gonorrhea/chlamydia cultures prior to insertion of the IUD. A brief survey to assess the     women's experience with the IUD, including symptomatology and satisfaction with the device,     will be conducted at the four months after insertion.   "
208812|NCT00584623|"     To correlate findings between two commonly-used types of swallowing studies: videofluoroscopy     and flexible endoscopic evaluation of swallowing (FEES).   "
208813|NCT00584636|"     The purpose of this study is to see if the addition of budesonide to oral corticosteroids     will result in a decrease in relapse rates compared to oral corticosteroids alone in children     who are discharged from the ED after an asthma exacerbation. Secondly, that there will be an     improvement in lung function, a decrease in beta-2 agonist use and an improvement in     health-related quality of life compared to placebo.   "
208815|NCT00584662|"     Nasal glucocorticosteroids (GCS) are considered first-line therapy for both allergic and     non-allergic rhinitis.1-3 Nasal congestion can persist despite maximum treatment with     intranasal GCS. No other drugs are superior to intranasal GCS in relieving nasal congestion.     For example, antihistamines are not effective in relieving congestion.1 Oral decongestants     are somewhat beneficial in relieving nasal congestion but can elevate blood pressure, cause     restlessness, and cause urinary retention. Oxymetazoline, however, is a potent decongestant     and the addition of it to a nasal GCS should add a considerable decongestant benefit. It may     also be beneficial in patients with persistent nighttime congestion despite maximum dosages     of nasal GCS.      Oxymetazoline is currently recommended for three days use because of the proposed risk of     rhinitis medicamentosa,4 which is increased nasal congestion caused by prolonged use of nasal     decongestant sprays.5-8 The term RM was coined early in the twentieth century after several     case reports described patients developing rebound congestion after using first generation     intranasal decongestants such as privine hydrochloride and ephedrine for prolonged     periods6,7. The histopathology and mechanism of RM has been based on animal models which may     not be pertinent to humans.9-13 Studies using oxymetazoline, a newer intranasal decongestant,     in individuals without rhinitis have shown conflicting evidence for the development of     RM.14-16 For example, normal individuals without rhinitis using oxymetazoline three times     daily for four weeks did not develop RM.17 Also, it is unknown the frequency of     administration and dosage of oxymetazoline it takes to induce RM or whether RM is just a     return to a patient's baseline nasal congestion as present before beginning oxymetazoline. It     is also unknown whether RM is more likely or only occurs with older vasoconstrictors such as     privine hydrochloride and ephedrine rather than oxymetazoline.      Nasal GCS reduce the amount of rebound congestion in patients with perennial allergic     rhinitis who have reportedly developed RM.18 Nasal GCS decrease nasal mucosa edema,     recruitment of neutrophils and mononuclear cells, cytokine production, and late-phase nasal     mediators.19-21 They may offer a protective benefit from the risk of developing RM.     Oxymetazoline may also decrease inferior turbinate hypertrophy thereby permitting better     adsorption of the nasal GCS.      Hypothesis      The addition of oxymetazoline to a nasal GCS for fourteen days will decrease the amount of     congestion in subjects with allergic or non-allergic rhinitis with persistent congestion     despite maximum recommended dosages of a nasal GCS. It is also hypothesized that nasal GCS     protect against the development of RM secondary to oxymetazoline.   "
208816|NCT00584675|"     Involves a 24-hour pH probe study using the Dx-pH Measurement System on patients who do not     have symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease to establish     normal values for the Dx-pH Measurement System.   "
208817|NCT00584688|"     Research studies raise the possibility that medications such as quetiapine may improve mood     or reduce obsessions in people with anorexia nervosa and may even help to normalize appetite.     The medication quetiapine also known as seroquel works by activating certain systems in the     brain, such as ones known as dopamine and serotonin chemical systems in the brain.   "
208818|NCT00584701|"     Autism is a complex neurodevelopmental disorder that is thought to involve an interaction     between multiple and variable susceptibility genes, environmental factors, and epigenetic     effects. Great concern has been raised about the marked increase in the prevalence of autism     spectrum disorders in the last decade. Risperidone, the most studied atypical antipsychotic     used in children, has been shown to improve severe behavioral difficulties in over half of     children with autism who have these difficulties. However, not all children with autism and     severe behavioral problems respond to risperidone, and for a few, it has significant side     effects.      Two controlled studies and numerous open-label and long term studies in children with autism     spectrum disorders using the atypical antipsychotic risperidone show a significant decrease     of associated serious behavioral problems. The use of atypical antipsychotics is of great     concern, however, because of their significant side effects and the fact that only two-thirds     of children positively respond. Ways to predict response, appropriate dosage and serious side     effects are needed.   "
208819|NCT00584714|"     The purpose of this study is to collect longer term follow-up information concerning health     and survival on selected patients who received PB127 for injectable suspension in the pivotal     trial (127-014).   "
208820|NCT00584727|"     The purpose of this study is to determine the relative performance of a new toric soft     contact lens against a toric and a spherical contact lens currently available in market,     specifically with regards to the fit and visual acuity as well as the comfort, vision and     satisfaction while in the practitioner's office. Approximately 2 hours duration.   "
208821|NCT00584740|"     This study will assess the safety and efficacy of AIN457 in patients with moderate to severe     active Crohn's disease.   "
208822|NCT00584753|"     This study is a feasibility study to determine if a combined breast PET/CT scanner can image     malignant functional activity while determining anatomical structure in the same clinical     setting for patients with breast cancer. End-points of this study are whether women will     accept the imaging position and timing, and whether functional properties of breast cancer     can be imaged with this device. The secondary purpose of this study is to explore protocol     parameters with a view to optimizing imaging performance whilst minimizing patient     discomfort. Imaging results will be compared to histological samples to determine ground     truth.   "
208823|NCT00584766|"     To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous     bone marrow transplantation after initial tumor cytoreduction for patients with     receptor-negative metastatic breast carcinoma and to determine the optimal timing of     CyBCNU-ABMT after initial development of metastatic breast carcinoma   "
208824|NCT00584779|"     To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects     with renal impairment, compare the results to Western study results and confirm the adaptive     possibility of dose adjustment in US package insert to Japanese.   "
208825|NCT00584792|"     This is a single center pilot study to asses the feasibility of conducting a larger     population-based study. It is an investigator-initiated study funded yb the UC Davis Cancer     Center's Development Award Program. The hypothesis is that the percent african ancestry in an     individual may determine their prognosis if diagnosed with prostate cancer.   "
208826|NCT00584805|"     This study is designed to determine the safety and immunogenicity of Eastern Equine     Encephalitis (EEE) Vaccine.   "
208827|NCT00584818|"     The purpose of this study is to determine the dose of PB127 for detection and/or exclusion of     coronary artery disease when used with cardiac ultrasound. This study also evaluates the     safety of PB127.   "
208828|NCT00584831|"     The relative performance of a new toric soft contact lens against toric contact lenses     currently available in market, specifically for visual acuity and lens orientation. The study     will be conducted in a staged approach (2 stages).   "
208829|NCT00584844|"     This study is designed to determine the safety and immunogenicity of a Live Francisella     tularensis Vaccine   "
208830|NCT00584857|"     This is a study to determine the optimal treatment for patients with advanced stage or     recurrent endometrial cancer. Traditionally, patients have been treated with either hormonal     therapies (megesterol) or chemotherapy (paclitaxel and carboplatin). This study investigates     the effectiveness of the combination of hormonal therapy and chemotherapy. This study also     will examine the side-effects associated with these drugs and the quality of life of patients     on combination therapy.   "
208838|NCT00584961|"     To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II     Disorder.      To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12     months using the assessment of the symptoms disease and the progress of metabolic and     cardiovascular risk.      To analyse the health status, quality of life and functioning/disability of patients.   "
208839|NCT00584974|"     To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major     Depressive Disorder   "
208840|NCT00576472|"     Children surviving some types of cancer have a higher risk of developing learning problems     after cancer treatment than do children who have not had cancer or its treatment. Cancer     treatment may cause problems with learning, attention, and memory. The purpose of this study     is to identify brain changes that may underlie learning problems in cancer survivors and     investigate whether methylphenidate (a stimulant medication) may reduce these problems.      Subjects who have had treatment for acute lymphoblastic leukemia (ALL) or a brain tumor will     be asked to take part in this research study. Siblings of some subjects will also be asked to     take part, so that their results can be compared with those of children who have had cancer     treatment. We hypothesize that children receiving more aggressive therapy will have lower     white matter brain volumes and these volumes will be significantly lower than age-matched     siblings. We also hypothesize that children who take methylphenidate will show improvements     on teacher and parent report measures of attention and social skills.   "
208841|NCT00576485|"     Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified     anterior aspheric surface results in reduced spherical aberration and improved contrast     sensitivity after cataract surgery.      Design: Prospective, comparative, interventional case series.      Methods: In an intraindividual randomized prospective study of 25 patients with bilateral     cataract, an IOL with a modified anterior surface (Tecnis Z9001, AMO- Group 1) was compared     with biconvex lens with spherical surfaces (ClariFlex®, AMO- Group 2). Ocular aberrations for     a 5.0 mm pupil and 6.0 mm pupil were measured with Hartmann-Shack aberrometer. Quality of     vision was measured by visual acuity and contrast sensitivity under mesopic and photopic     conditions. All patients were followed for 3 months.   "
208842|NCT00576498|"     Primary Aim: In patients with endoscopically suspected BE, compared to standard endoscopy,     novel techniques (NBI and AFI) with target biopsies will        -  Detect more patients with intestinal metaplasia        -  Detect more areas of high grade dysplasia        -  Require fewer biopsies and a shorter time for procedure completion      Secondary Aim:        -  Compare the yield of high-grade dysplasia(HGD)using NBI/AFI versus standard endoscopy          with biopsy.        -  Compare the number of biopsies and procedure times for NBI/AFI versus standard endoscopy          with biopsy.        -  Compare the inter-observer variability in classifying different mucosal and vascular          patterns observed by NBI/AFI using kappa statistics.   "
208843|NCT00576511|"     The purpose of this study is to determine whether prucalopride is safe and effective in     patients with severe chronic constipation.   "
208844|NCT00576524|"     The purpose of this study is to evaluate the application of the impedance threshold device     during hemodialysis in children to optimize fluid removal, reduce the incidence of     complications (such as cramps,vomiting and hypotension), and device tolerance.   "
208845|NCT00576537|"     This research is being determine whether vaccinations with your own immune cells called      dendritic cells  can activate your immune system to fight your brain tumor.   "
208846|NCT00576550|"     The purpose of this study is to investigate whether a moisturizing cream can prevent hand     eczema.Patients with previous hand eczema will be studied. In the second part of the study,     it will be explored if a treatment regimen of a topical corticosteroid once daily is not     inferior to treatment twice daily.   "
208847|NCT00576563|"     To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour     characteristics determined in the plasma of patients with rectal cancer during and after     radiotherapy or combined radiotherapy and chemotherapy.      The changes of the FDG uptake of the primary tumour and the evolution of key tumour     characteristics during radiotherapy alone or in combination with chemotherapy will be     predictive for the pathological tumour response.      Study hypothesis The changes of the FDG uptake of the primary tumour and the evolution of key     tumour characteristics during radiotherapy alone or in combination with chemotherapy will be     predictive for the pathological tumour response.   "
208848|NCT00576576|"     The purpose of this study is to evaluate the effects of Atorvastatin on the coronary     atherosclerosis plaque morphology.   "
208849|NCT00576589|"     The study is designed to assess whether repeated dosing with CE-326,597 will cause patients     with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become     symptomatic. In addition, the study will characterize the pharmacokinetics of CE-326,597.   "
208850|NCT00576602|"     This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera,     versus no ESA therapy, in chronic kidney disease patients with anemia after kidney     transplant, not currently treated with ESA. Patients will be randomized to receive     a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks,     switching to monthly treatment at week 16 or b)supportive treatment (eg. iron     supplementation) for management of low hemoglobin concentrations. The anticipated time on     study treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
208898|NCT00577265|"     An observational study to investigate how patients experience the ability to adjust their     asthma maintenance medication according to instructions received from their physician. The     primary aim is to create an insight in the perception of the patient when he has the ability     to adjust his own maintenance treatment and how the patient exercises this in the daily     practice.   "
208851|NCT00576615|"     The purpose of this study is to relate changes in the blood flow in your brain which are     measured using magnetic resonance imaging (MRI) to temporary changes in your memory and level     of sleepiness while receiving the drug propofol, which is commonly used to induce relaxation     or sleepiness for minor surgical procedures. This study will help provide us information     which will be useful in understanding which parts of the brain are influenced by these drugs     to affect memory and sleepiness.   "
209260|NCT00576277|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of     AV411 after single and multiple doses in patients with chronic neuropathic pain due to     diabetes.   "
208852|NCT00576628|"     This single arm study will assess the efficacy, safety and tolerability of subcutaneous     C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with     chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible     patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight     (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study     treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
208853|NCT00576641|"     The purpose of the Dendritic Cell Immunotherapy study for patients with glioblastoma and/or     brainstem glioma is to determine whether in patients with malignant brain tumors, dendritic     cells injected peripherally can reactivate the immune system against the brain tumor.   "
208854|NCT00576654|"     This phase I trial studies the side effects and best dose of veliparib when given together     with irinotecan hydrochloride in treating patients with cancer that has spread to other parts     of the body or that cannot be removed by surgery. Irinotecan hydrochloride can kill cancer     cells by damaging the deoxyribonucleic acid (DNA) that is needed for cancer cell survival and     growth. Veliparib may block proteins that repair the damaged DNA and may help irinotecan     hydrochloride to kill more tumor cells. Giving irinotecan hydrochloride together with     veliparib may kill more cancer cells.   "
208855|NCT00576667|"     The purpose of this study is to assess the effect of Rimonabant treatment on the histological     features of Nonalcoholic Steatohepatitis (NASH).   "
208856|NCT00576680|"     This research study will test the safety of RAD001 in combination with temozolomide.   "
208857|NCT00576693|"     PRIMARY HYPOTHESIS:      Compared with intensive medical therapy alone, intracranial angioplasty and stenting combined     with intensive medical therapy will decrease the risk of the primary endpoint by 35% over a     mean follow-up of two years in high-risk patients patients with 70% - 99% intracranial     stenosis who had a transient ischemic attack (TIA) or stroke within 30 days prior to     enrollment) with symptomatic stenosis of a major intracranial artery.      SUMMARY:      The best treatment for prevention of another stroke or TIA in patients with narrowing of one     of the arteries in the brain is uncertain. A common treatment is the use of anti-clotting     medications to prevent blood clots from forming in the narrowed vessel. There are a variety     of medicines used for this purpose. These medications are usually taken for the rest of a     patient's life.      However, a treatment that has been used successfully together with anti-clotting medications     in patients with narrowing of the blood vessels of the heart is now being studied in the     blood vessels of the brain. This treatment is called stenting.      Recent research has also indicated a benefit in prevention of recurring stroke by Intensive     Medical Therapy, which is defined as treating risk factors for stroke like high blood     pressure, elevated LDL (low density lipids - the bad form of cholesterol) and diabetes. The     purpose of this study is to compare the safety and effectiveness of either Intensive Medical     Therapy PLUS Stenting or Intensive Medical Therapy ONLY in preventing stroke, heart attacks     or death.      The study will enroll patients over a 5 year period. Each participant will be involved in the     study for a minimum of 1 year and a maximum of 3 years.      Fifty different medical centers in the United States are part of this study. Both the     Clinical Coordinating Center and the Statistical Coordinating Center for the entire study     will be located at Emory University.   "
208858|NCT00576706|"     To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of     Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.   "
208859|NCT00576719|"     This study will evaluate the effectiveness of intensive cognitive behavioral therapy in     treating adolescents with panic disorder with agoraphobia.   "
208860|NCT00576732|"     The purpose of this study is to evaluate the effectiveness (change in level of irritability     and related behaviors) and safety and tolerability of the administration of 2 different fixed     dose levels of risperidone (an atypical antipsychotic drug) compared with placebo in children     or adolescents who have autism, and to evaluate the safety and tolerability of the drug for     additional 26 weeks after the initial 6-week study period.   "
208861|NCT00576745|"     Following closure of surgical incisions, wounds may develop redness, swelling, and drainage     which may result in increased pain and infection. This study will test to hypothesis that     using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness,     swelling, and infections in a group of patients undergoing a mediastinotomy incision used for     open heart surgical procedures.   "
208862|NCT00576758|"     This study will investigate the efficacy of weekly intravenous obinutuzumab [GA101     (RO5072759)] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma.     Patients will be randomized to receive either GA101 or rituximab, given as four weekly     infusions. At the conclusion of the initial trial patients may be eligible to continue     therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the     target sample size is 100-500 individuals.   "
208863|NCT00576771|"     The investigators' aim is to study the effect of pressure support ventilation versus neurally     adjusted assist (NAVA) and controlled by patient in mechanically ventilated ALI/ARDS     subjects.   "
208864|NCT00576784|"     The goal of the study is to demonstrate whether a switch from insulin therapy to an oral     therapy with pioglitazone/glimepiride will lead to a deterioration of glycemic control     (increase in HbA1c by more than 0.5 %) within a 6 month observation period.   "
208865|NCT00576797|"     The human vagina contains a large number of normal bacteria. These bacteria are important     because provide protection against other bacteria that may cause disease. Several important     diseases are linked to abnormal bacteria in the vagina. Women with abnormal bacteria in the     vagina are more likely to be infected with human immunodeficiency virus, the virus that     causes AIDS. Also women with unusual bacteria in their vagina are more likely to deliver a     premature baby when they are pregnant. For these reasons, it is important to have a better     understanding of the normal bacteria of the vagina.Some bacteria found in the vagina can not     be grown in a laboratory. Our preliminary studies indicate a very wide variety of bacteria in     the vagina. Also we have shown there are some differences between African American and     Caucasian women. The goal of our study is to study the bacteria in the vagina of normal women     using the latest technology. This technology involves study the bacterial DNA present in the     normal microbes in the vagina   "
208866|NCT00576810|"     The objective ot the study is to compare the efficacy and safety of 4 weeks treatment with     sodium picosulphate drops 10mg to placebo in patients with functional constipation. In     addition the effect of treatment on quality of life and general health status will be     evaluated   "
208867|NCT00576823|"     Primary objective was to determine efficacy of Alfuzosin in the treatment of children and     adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to     elevated detrusor Leak Point Pressure [LPP] of neuropathic etiology.      Secondary objectives were:        -  To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and          adolescents,        -  To investigate the number of Urinary Tract Infection (UTI) episodes,        -  To investigate the pharmacokinetics of Alfuzosin (population kinetics).   "
208868|NCT00576836|"     One purpose of this study is to determine whether the amount of thymus tissue transplanted     into DiGeorge anomaly infants has any effect on the immune outcome. Another purpose of this     study is to determine whether parental parathyroid gland transplantation (in addition to     thymus transplantation) can help both the immune and the calcium problems in DiGeorge infants     with hypocalcemia. [Funding Source - FDA OOPD]   "
208869|NCT00576849|"     A total balanced fluid replacement strategy is a promising concept for correcting     hypovolemia. The effects of a balanced fluid management including a new balanced     hydroxyethylstarch (HES) in elderly cardiac surgery patients will be studied.   "
208870|NCT00576862|"     The purpose of this trial is to allow patients to continue on HOE 901 until launch and to     gather additional long-term safety data.   "
208871|NCT00576875|"     The proposed Silvio O. Conte Center for Neuroscience of Depression will focus on     understanding the neurobiological mechanism of depression. A total of 5 projects are     proposed. The center is focused on a single hypothesis. The first project examines     localization of lesions, structural changes in critical regions subserving the circuit,     alterations in the white matter tracts relevant to the circuit and changes in glutamate. The     second project uses post mortem cell counting and cellular localization in serotonin     receptors and assessment of the type of cell loss in the orbitofrontal cortex. The third     project uses cognitive paradigms and functional MRI to probe the circuit and the role of     brain lesions and serotonin on the functioning of this circuit. The fourth project uses     transgenic and knockout mice to examine to role of norepinephrine and serotonin as it relates     to the circuit. The final project is designed to assess in these transgenic mice using     multielectrode array of single neuron recordings of the firing pattern of the circuit neurons     in various states and tasks and the role of monoamines in modulating this circuit.   "
208872|NCT00576888|"     PURPOSE The purpose of this study is to learn more about multifocal     lymphangioendotheliomatosis with thrombocytopenia (MLT). MLT is a rare vascular disorder     characterized by multiple congenital skin and visceral lesions, profound thrombocytopenia,     and gastrointestinal bleeding. The skin lesions may appear red, brown or blue, often     misdiagnosed as hemangiomas. The gastrointestinal tract, liver, and lungs are the most common     internal organs involved. The severe thrombocytopenia (low platelets) is believed to be the     result of platelet trapping within the skin and visceral vascular lesions. Severe and chronic     gastrointestinal bleeding is common during infancy and early childhood. Although a relatively     newly described entity, MLT was likely previously reported as hemangiomas, blue rubber bleb     nevus syndrome, diffuse hemangiomatosis, Kasabach-Merritt phenomenon, and hereditary     hemorrhagic telangiectasia. The term cutaneovisceral angiomatosis with thrombocytopenia is     also a term used for this same disease. This study is a longitudinal cohort study of MLT to     collect detailed clinical data on the distribution of disease, disease severity, and     complications. This data will be used to create diagnostic criteria and an evaluation     protocol for infants with this disease   "
208873|NCT00576901|"     This single arm study will assess the efficacy and safety of combination first-line treatment     with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast     cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each     cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2     p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional     additional two cycles; after chemotherapy patients will be assessed for surgery. The     anticipated time on study treatment is 3-12 months, and the target sample size is <100     individuals.   "
208874|NCT00576914|"     This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar     prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with     completely resected IB-IIIA non-small-cell lung cancer.      The patients with completely resected stage IB to stage IIIA non-small cell lung cancer were     randomly assigned to the group of vinorelbine plus cisplatin plus endostar or to the group of     vinorelbine plus cisplatin . The primary end point was overall survival; principal secondary     end points were recurrence-free survival and the toxicity and safety of the regimens.   "
208875|NCT00576927|"     Older people living in nursing homes do not sleep very well for many reasons. Sleep disorders     such as sleep apnea (when someone briefly stops breathing during sleep), and night time     urination, along with the problems caused by the nighttime environment of the nursing home,     such as noise and disruptive care routines can all contribute. Poor sleep can lead to other     health problems or make existing health problems worse.      This study will evaluate how well a sleep hygiene intervention and a medication for sleep     (ramelteon (Rozerem)) work to improve sleep in nursing home residents with poor sleep.     Ramelteon is FDA approved and has been tested in older adults living in the community, but     not in older adults living in nursing homes. We expect sleep to improve on the study drug     along with the sleep hygiene intervention, in comparison to placebo along with the sleep     hygiene intervention. Based on adverse events reported in previous samples of older subjects,     we expect the study drug to cause few side effects.   "
208876|NCT00576940|"     The aim of the study was to assess the clinical effect of immunomodulating enteral nutrition     in patients undergoing resection for gastrointestinal cancer. 196 subjects were randomly     assigned into two study groups: standard and immunostimulating. The study failed to     demonstrate any clear advantage of routine postoperative immunonutrition in patients     undergoing elective upper gastrointestinal surgery   "
208896|NCT00577226|"     The objective of this study is to retrospectively and prospectively review patients who have     undergone this technique looking at age of the patient, magnitude of the curve     preoperatively, postoperatively and over time, diagnosis, pulmonary function, surgical     procedures, complications, and spinal growth.      The hypothesis is that Shilla growth permitting spinal instrumentation coupled with a     surgical technique of aggressive correction of the apex of the scoliotic curve wil allow for     natural growth of the spine in a guided fashion with a limited number of future surgeries     required.   "
208944|NCT00577902|"     This study is being conducted to define the specific nutritional biomarkers and nutritional     risk during the course of chemoradiation therapy for cancers of the head and neck. This     prospective, longitudinal observational study is focused on specific antioxidants and B     vitamins. The ORAC was selected as an index of overall antioxidant capacity. We chose to     evaluate antioxidant status because administering antioxidants has been shown to reduce     chemotherapeutic agent toxicities.   "
208877|NCT00576979|"     RATIONALE: Giving intensity modulated radiation therapy (IMRT) and chemotherapy, such as     etoposide and cyclophosphamide, before a donor stem cell transplant helps stop the growth of     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem     cells. When the healthy stem cells from a donor are infused into the patient they may help     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Sometimes the transplanted cells from a donor can make an immune response against the body's     normal cells. Giving IMRT together with chemotherapy before transplant may stop this from     happening.      PURPOSE: This phase I/II trial is studying the side effects and best dose of     intensity-modulated radiation therapy (IMRT) when given together with etoposide and     cyclophosphamide followed by donor stem cell transplant and to see how well they work in     treating patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute     myeloid leukemia (AML).   "
208878|NCT00576992|"     The purpose of this study is to evaluate the demographics, patients symptoms, and findings     during endoscopy. Patients presenting for an endoscopy procedure to the KCVA GI endoscopy     suite, will be asked to fill out questionnaires pertaining to their symptoms and indications     for the procedure. This will be done before their procedure during the interview period     preceding endoscopy. The patient's answers to this questionnaire will aid us in determining     the prevalence of gastric and esophageal disease in patients presenting with the complaints     of dyspepsia, GERD, or extraesophageal symptoms and to also determine whether the presence of     any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above     endoscopic diagnoses.   "
208879|NCT00577005|"     Concurrent dependence on cocaine occurs in up to 50% of the over one million opiate dependent     patients in spite of methadone maintenance treatment being highly effective for opiate     dependence and having excellent treatment retention. Cocaine dependence has remained largely     unresponsive to medications both in and outside of these methadone programs. We have initial     data from our open-label study with levetiracetam showing that this medication is well     tolerated and may reduce cocaine use in this cocaine-abusing methadone treated population.      The specific aim of this study is to evaluate the efficacy of levetiracetam 3 grams/day in     modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's     reinforcing effect among methadone-maintained patients. The primary outcomes will be     reduction in cocaine use as assessed by self-report and thrice-weekly urinalyses. Secondary     outcomes will include weeks in treatment (retention) and change in measures of cocaine     craving, anxiety symptoms and opiate withdrawal symptoms.   "
208880|NCT00577018|"     The purpose of this study is to determine the safety profile of 4 mg prucalopride in the     treatment of chronic constipation.   "
208881|NCT00577031|"     This single arm study will evaluate the efficacy and safety of a first-line regimen of     Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or     rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on     day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14,     for a maximum of 6 months. Patients with stable disease or complete or partial response may     continue on Avastin therapy. The anticipated time on study treatment is until disease     progression, and the target sample size is 100-500 individuals.   "
208882|NCT00577044|"     The true incidence and prevalence of NAFLD in Hong Kong has not been determined. The natural     history of NAFLD is not well defined partly because of differences in the exclusion limit of     alcohol and the required histological criteria between studies. NAFLD is previously believed     to be a benign non-progressive condition, but it has since been determined that a subset of     patients can progress to cirrhosis and even hepatocellular carcinoma.      In fact in a recent histological review of NAFLD, fibrosis or liver cirrhosis was present in     15-50% of patients at index liver biopsy. The presence of obesity or type 2 diabetes mellitus     are the strongest predictors of fibrosis. These same risk factors are also more common in     patients with cryptogenic cirrhosis. Further evidence of the link between diabetes, obesity     and NAFLD are mainly from the field of liver transplantation. In patients who underwent liver     transplantation for cryptogenic liver cirrhosis, NAFLD recuured in a quarter of the hepatic     allografts. The patients with recurrent NAFLD were more likely to be diabetic and had a     higher body mass index (BMI) at the time of recurrent NAFLD. This suggests that NAFLD may     have a significant role in the pathogenesis of crytogenic cirrhosis.      Although NAFLD was initially described as a slowly progressive disease, there are emerging     data which shows that it can progress rapidly. Liver failure has even been described in     patients with NAFLD after bariatric surgery, and a recent report described 5 cases of     subacute liver failure in obese middle aged females with NAFLD related cirrhosis. NAFLD can     also affect the progression of other diseases as well. Hepatic steatosis related to visceral     obesity is a major independent risk factor for fibrogenesis related to chronic HCV hepatitis.      However, the prevalence of NAFLD and its interaction with chronic HBV, if any, is uncertain.     This study aims to determine the prevalence of NAFLD in patients with unknown cause of     hepatitis and to determine the histological fibrosis and inflammation in chronic HBV patients     with NAFLD.   "
208883|NCT00577057|"     The objectives of this clinical study are threefold:        1. To compare the benefits in cancer control and survival obtained from adding          induction-concurrent chemotherapy to radiation with those from adding          concurrent-adjuvant chemotherapy to radiation.        2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin (PF or          PX, respectively) in the chemotherapy plan will maintain or improve further the          chemotherapy benefits while reducing the duration of hospital stay.        3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as          compared with conventional fractionation radiotherapy.   "
208884|NCT00577070|"     There is a general consensus of efficacy of TMS in treatment of major depression,yet results     are not satisfying.A new coil (H-coil, recently invented in Weizmann Institute of Science,     Neurobiology Department, Rehovot, Israel) is supposed to be capable of stimulating deeper     brain structures than conventional coils.TMS using this coil was named by its developers as     deep TMS and will hence be refered to by this name.      So far, deep TMS have studied in Israel with promising sucssess in patients with Major     depression (An on-going study).A safety study with good results have been recently     published.The aim of this study is to reinforce initial results in major depression using     deep TMS.   "
208897|NCT00577252|"     In this research, we will use established surveys to look at the relationship between various     styles of coping with a disease, religious coping styles, treatment compliance, locus of     control, broad measures of mental health and adjustment, and basic health data (e.g., PFTs,     recent hospitalizations or antibiotics within the past year, lung microbiology, CFTR     mutations, and co-morbid conditions such as diabetes, depression, and liver disease). While     the research is correlational, it should suggest relationships (both positive and negative)     between various coping styles and desired outcomes (compliance and well-being).   "
208958|NCT00578097|"     The purpose of this study is to determine the optimal dose of botulinum toxin type A injected     in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life     of continent women suffering from idiopathic overactive bladder.   "
208885|NCT00577083|"     This is a test in which a thin, black, flexible tube with a lighting system on the end is     passed through the anus, into the rectum, in order to examine the large bowel or intestine,     also called the colon. Colonoscopy is a very good test for examining the colon for polyps     (warty growths that can turn into cancer), but it is not perfect. In fact, about 30% of     polyps that are under 5 mm (about 1/5 of an inch) in size are missed during colonoscopy     because they are hiding behind folds and bends in the colon. This research study is being     done to determine if performing colonoscopy with a cap on the tip of the colonoscope will     reduce the miss rate for polyps. A cap is a clear plastic hood that fits on the tip of the     colonoscope and sticks out about 1/3 of an inch. During colonoscopy, the cap can be pressed     against a fold or ridge in order to flatten it, so that the lining on the other side can be     more easily seen. This may reduce the miss rate for colon polyps.   "
208886|NCT00577096|"     The purpose of the study was to determine the effect of Epoetin alfa therapy (short term     versus long term) with and without a home-based individualized exercise program that     incorporated aerobic and strength resistance training for patients being treated with     high-dose chemotherapy and autologous peripheral bloodstem cell transplantation (PBSC T) for     multiple myeloma. The endpoints for the study included the number of attempts at and total     number of days of stem cell collection, number of RBC and platelet transfusions during the     transplantation period, time-to-recovery after transplantation, and response to intensive     therapy for multiple myeloma.   "
208887|NCT00577109|"     This single arm study will assess the efficacy and safety of a combination of modified     FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously     untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan     180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in     combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of     400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study     treatment is until disease progression or unacceptable toxicity, and the target sample size     is <100 individuals.   "
208888|NCT00577122|"     The purpose of this study is to evaluate the impact of MPA alone and in combination with low     dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.   "
208889|NCT00577135|"     Heart failure is a disorder in which the heart does not pump blood adequately. This can lead     to several serious problems, including reduced blood flow throughout the body, congestion of     blood in the veins and lungs, and fluid accumulation in various organs and limbs. Diuretics     are often used to address the problem of fluid accumulation, but the optimal dose and the     amount of time over which to administer each dose are unclear. This study will compare high     and low doses of diuretics administered over longer and shorter periods of time to determine     the safest and most effective combination.   "
208890|NCT00577148|"     The purpose of this study is to assess the effect of rimonabant treatment on the histological     features of Nonalcoholic Steatohepatitis (NASH) in patients with Type 2 diabetes.   "
208891|NCT00577161|"     BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and reduced     delayed cardiotoxicity in animal models compared to reference standards. This cytotoxic agent     has structural similarities to mitoxantrone as well as general similarities to anthracyclines     (such as the tricyclic central quinoid chromophore7).      This phase III study will compare the efficacy and safety of the combination BBR 2778,     fludarabine, and rituximab with the combination fludarabine and rituximab in patients with     relapsed or refractory indolent non-Hodgkin's lymphoma.   "
208892|NCT00577174|"     The prevalence of pediatric obesity is increasing at an unprecedented rate. Obese children     are at risk for the development of insulin resistance, relative insulin deficiency and type 2     diabetes mellitus. However, the cause of insulin resistance remains an area of scientific     interest. The study of type 2 diabetes in children is limited by the lack of a non-invasive     method to evaluate insulin resistance. Recent studies have suggested that mitochondrial     dysfunction is associated with, and perhaps predictive of insulin resistance in adult     relatives of individuals with type 2 diabetes. Mitochondria generate energy in muscle tissue     through the production of ATP, and are important in the metabolism of both glucose and fat.     This study evaluates a novel, non invasive, safe method for predicting insulin resistance and     diabetes in children using a magnetic resonance imaging (MRI) based technique to measure     mitochondrial function. We propose to investigate mitochondrial function and glucose     metabolism in obese and non-obese children in early, mid and late puberty. Analyses will be     conducted to investigate the presence of mitochondrial dysfunction in obese children, to     evaluate the contribution of mitochondrial dysfunction to insulin resistance, and to     determine the contribution of pubertal status to mitochondrial dysfunction and insulin     resistance. The successful completion of this study would provide evidence to support the     hypothesis that mitochondrial dysfunction plays a role in insulin resistance and diabetes in     children. In addition, it would provide a new technique for the prediction of disease states     and perhaps lead to the development of preventative therapeutics for insulin resistance and     type 2 diabetes in children.      We hypothesize that mitochondrial dysfunction will mirror the progression of insulin     resistance and precede and predict abnormal glucose metabolism in a population with pediatric     obesity   "
208893|NCT00577187|"     This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help     guide the placement of the left ventricular lead during cardiovascular resynchronization     therapy implant procedures with the goal of reducing fluoroscopic exposure and procedure     time.   "
208894|NCT00577200|"     Patients are currently advised to refrain from driving motor vehicles or using public     transportation unescorted for a 24 hour period if they undergo any minor ambulatory surgical     procedure with monitored anesthesia care (MAC).However, recently introduced short-acting     anesthetics may facilitate rapid recovery and an early return to normal daily activities. The     proposed study will compare newer short-acting anesthetic agents (propofol, benzodiazepine,     opioid) utilized in MAC, to determine if a particular pharmacological agent, or a combination     of agents, impair driving performance as evaluated by driving simulator assessment, at time     of discharge from the ambulatory center after minor surgical procedures.Subjects will be     grouped as patients with chronic pain undergoing procedures and those without chronic pain     undergoing procedures. Subjects with pain issues will be randomized with either 1)Midazolam +     Sufentanil + Propofol or 2)Midazolam + Sufentanil. There will be a third group of subjects     who are controls not undergoing any procedures.   "
208895|NCT00577213|"     To develop a non-invasive, simple and affordable, measurement technique to differentiate     hemangiomas from subtypes of VMS. The purpose of this study is to determine the best office     based diagnositc instrument for differentiating the subtype of vascular lesions. The     instrument must be simple and affordable so it can be used by primary car physicians in the     doctor office. The procedure will be based on non-invasive and unharmful measurements that     will be compared to the diagnosis from specialized physicians in this field and the final     pathology.   "
208959|NCT00578110|"     To introduce a rapid and objective electrophysiological technique that can assess visual     function in the magnocellular pathway, which is thought to be affected in early-stage     glaucoma.   "
208899|NCT00577278|"     RATIONALE: Giving monoclonal antibody therapy, radioimmunotherapy, and chemotherapy before a     donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's     immune system from rejecting the donor's stem cells. When the stem cells from a related donor     that do not exactly match the patient's blood, are infused into the patient, they may help     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Sometimes the transplanted cells from a donor can also make an immune response against the     body's normal cells. Giving tacrolimus and sirolimus before and after transplant may stop     this from happening.      PURPOSE: This phase II trial is studying the side effects and how well giving indium In 111     ibritumomab tiuxetan and yttrium y 90 ibritumomab tiuxetan together with rituximab,     fludarabine, melphalan, and donor stem cell transplant works in treating patients with B-cell     non-Hodgkin lymphoma.   "
208900|NCT00577304|"     The purpose of this research study is to test the safety, tolerability, and effectiveness of     Topical AmphiMatrix with Nitroglycerin (MQX0503) to relieve Raynaud's symptoms and increase     blood flow to the fingers.   "
208901|NCT00577317|"     This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how     well it works compared with standard home maintenance therapy in treating patients with     lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or     endometrial cancer. Flexitouch® home maintenance therapy may lessen lower-extremity     lymphedema caused by treatment for gynecologic cancer. It is not yet known whether the     Flexitouch® system is more effective than standard home maintenance therapy in treating     lymphedema.   "
208902|NCT00577330|"     Myalgesin is a botanical preparation consisting of celery seed extract,extract of dried     Boswellia serrata, and dried extract of Phellodendron bark. Component of these extracts have     been shown to exert anti-inflammatory effects and to inhibit cyclooxygenase and     5-lipooxygenase. The study is based on the hypothesis that oral administrration of this     botanical will support joint function in people with osteoarthritis of the knee and improve     symptoms and mobility as measured by the Western Ontario and McMaster Universities (WOMAC)     Osteoarthritis Index.   "
208903|NCT00577343|"     Hospital acquired and community acquired methicillin resistant staph aureus (MRSA) has become     an important health issue for in recent years. Up to two thirds of patients that are     hospitalized may be colonized with MRSA. The prevalence in the community is also on the rise     and affects the young and healthy. It is unclear what the true prevalence of MRSA is in our     own hospital and outpatient setting. This information would be relevant to how healthcare     staff adhere to contact and universal precautions. : The purpose of this study is to     determine the prevalence of MRSA in patients that have gastrointestinal endoscopy and     endoscopic ultrasound.   "
208904|NCT00577356|"     The purpose of this study is to find out what effects, good and bad, the combination of     docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before     removal the prostate (prostatectomy).   "
208905|NCT00577369|"     In this feasibility study we will collect blood from indwelling arterial catheters in up to     20 patients undergoing non-emergent surgery with desflurane anesthesia at Children's Hospital     of Philadelphia. Desflurane levels will be determined by high pressure liquid chromatography     (HPLC).      Our eventual goal is to quantify fetal levels of desflurane in umbilical cord blood during     fetal surgery. We propose a pilot study to assess the ability of our assay to measure     desflurane in human blood.   "
208906|NCT00577382|"     The purpose of this study is to evaluate how effective Sunitinib works in treating acral     lentiginous and mucosal melanoma which has spread beyond the local region. Suninitib is a     protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work     by blocking signals on certain cancer cells which allow the malignant cells to multiply and     spread due to a change in the genetic make up of the cancer cell.   "
208907|NCT00577395|"     The purpose of this trial is to compare the difference in bone microarchitecture of the     distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg     taken once a month compared to placebo.   "
208908|NCT00577408|"     In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the     new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide     initial clinical experience with the new Depot-BNT treatment model, while providing a     rigorous test of whether Depot-BNT produces superior treatment outcome, compared to our best     behavioral platform for oral naltrexone (BNT).      The following aims will be addressed:      Specific Aim #1: To test whether Depot-BNT increases retention in treatment and improves drug     use outcome (urine-confirmed abstinent weeks) compared to our established model of BNT with     oral naltrexone (BNT-Oral), and to explore whether Depot-BNT (vs BNT-Oral) improves key     secondary outcomes including dysphoria, HIV risk behavior, and social functioning.      Specific Aim #2: To explore predictors of outcome on Depot-BNT, and mechanisms of attrition,     in order to optimize Depot-BNT prior to further testing.   "
208909|NCT00577421|"     A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density     and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal     Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080,     and RVE2001079 (NCT01249261)   "
208910|NCT00577434|"     This medication is used for procedural sedation and sedation for diagnostic imaging. The     purpose of this study is to find out what happens to pentobarbital in the body after it is     given to children who have had heart surgery.   "
208911|NCT00577447|"     The purpose of this study is to test the hypothesis that dietary supplementation with the     omega-3 fatty acid docosahexaenoic acid (DHA) improves the behavior of children with autism.   "
208912|NCT00577460|"     The general aim of this study is to obtain long-term safety and tolerability data on     pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in     patients who have previously completed a pramipexole double-blind study in advanced     Parkinson's disease (PD) (248.525 trial).   "
208913|NCT00577473|"     The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg     tablet) versus Asacol 2.4 g/day (400 mg tablet   "
208957|NCT00578084|"     The purpose of this repository is to prospectively examine subjects with known or suspected     lung cancer to determine the extent of mediastinal lymph node involvement with respect to     primary lung cancer location. The data collected in this repository may be used to influence     our current standard of care and streamline indications for EUS.   "
208914|NCT00577499|"     Cystic fibrosis (CF) results in thickened secretions in multiple organ systems including the     lungs and gastrointestinal (GI) tract. Patients commonly suffer from nutritional deficiency,     and achieving and maintaining adequate nutrition is an important goal of therapy because it     is positively correlated with lung function. Lubiprostone activates chloride channels in the     GI tract. Because its mechanism of action closely parallels the disease pathology,     lubiprostone has the potential to provide GI benefits beyond the relief of constipation. This     project is an observational study to examine the effects of lubiprostone on nutritional     status and lung function in adults with CF. Our hypothesis is that lubiprostone will have     beneficial effects on nutritional status.   "
208915|NCT00577512|"     This study is being done in an attempt to improve the remission rate and the survival time     for subjects with high-risk myeloma. It is hoped that by giving higher doses of commonly used     chemotherapy drugs and by giving courses closer together (before the myeloma comes back or     gets worse), subjects in this study will have better outcomes.   "
208916|NCT00577525|"     The primary purpose of the study is to evaluate the association of a latent infection of     lymphoid cells during the first manifestation of steroid sensitive nephrite syndrome. The     thirty nine units of general pediatrics and pediatric nephrite covering the parisian area     will participate to the study. We speculate that hybridization of the genome, or a part of     the genome, of a virus in lymphoid cells is responsible specific changes of genes expression,     leading to the development of the disease.   "
208917|NCT00577538|"     Patients with inflammatory bowel disease (IBD) may be at increased risk of lymphoma. The     majority of lymphomas in patients with IBD occur in areas of active inflammation. The     relationship between IBD and lymphoproliferative disease is however unclear, since both     chronic inflammation as well as medications used to treat IBD (especially immunosuppressives     - Azathioprine or 6-MP - and anti-TNF alpha agents) have been associated with increased risk     of lymphoma. We plan to study the association between IBD and lymphoma in a large, mixed,     community based and referral population from the IBD database at Indiana University.   "
208918|NCT00577564|"     The purpose of this retrospective study is to measure the safety of EUS-CPN in patients that     have undergone this procedure in the last decade.   "
208919|NCT00577577|"     To investigate the effects of rhIGF-I/rhIGFBP-3 treatment for 24 weeks on endurance,     ambulation, cognitive functioning, insulin resistance, lipid levels, muscle function and     strength, pain, gastrointestinal functioning, and quality of life endpoints in DM1 patients   "
208920|NCT00577590|"     Type 2 diabetes mellitus (T2DM) is a disease that interferes with the body's proper     production and use of insulin, a hormone needed to convert sugar into usable energy. People     with T2DM are at a higher risk for certain cardiovascular diseases, including heart disease     and stroke. Normal treatments for T2DM target blood sugar levels only, but there is reason to     believe that also targeting blood fat levels will improve both sugar metabolism and heart     function in people with T2DM. This study will determine the effectiveness of blood-fat     lowering treatments along with blood-sugar control treatments in improving heart function and     symptoms of people with T2DM.   "
208921|NCT00577603|"     This study is being done to evaluate the use of a material (Alloderm collagen mesh) during     the stomal formation operation (surgery that will create a mouth-like opening on the surface     of the body to an internal organ). The main purpose of this research study is to see if using     this material will lower the hernia rate compared to normal repair without this material. The     secondary purpose is to evaluate if using this material will increase or decrease     complication rates.   "
208922|NCT00577616|"     The aim of this multicenter randomized trial is to compare the endovascular repair versus     conventional repair for ruptured aorta-iliac aneurysms observed on CT scan in stable patients     with suitable anatomy. The main awaited result is the significant reduction of the mortality     of the conventional repair.   "
208923|NCT00577629|"     The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal     antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients     with high-risk Non-Hodgkin's Lymphoma (NHL).   "
208924|NCT00577642|"     The purpose of this research study is to define the time a molecule in the participants bones     called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in     the urine to determine the rate of bone breakdown. Tracking this marker may help identify a     more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic     acid, which will be used in this study, are used to reduce pain and bone fractures in people     with multiple myeloma. There is some laboratory data to suggest that they may work against     myeloma. Participants will have already undergone bisphosphonate therapy and may have     received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due     to concerns of their long-term side effects we are looking at alternate strategies for     reducing the frequency of these agents.   "
208925|NCT00577655|"     The primary objective of this study is to evaluate the chronic-dose and efficacy of     Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.   "
208926|NCT00577668|"     In this study, researchers want to find out if using the VTD regimen, along with higher doses     melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be     given safely to subjects who have failed previous transplant(s).   "
208927|NCT00577681|"     HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease for     which there is not yet a cure. Antiretroviral therapy (ART) has proven an effective treatment     for inhibiting the replication of HIV, allowing for improved quality of life and survival.     Previous studies indicate that episodic use of ART is associated with increased risk of     cardiovascular disease (CVD). This study will determine mechanisms underlying the increased     CVD risk among people infected with HIV and, specifically, in those who receive episodic ART.   "
208928|NCT00577694|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Giving clofarabine together with gemtuzumab     may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when     given together with gemtuzumab in treating patients with relapsed or refractory acute myeloid     leukemia.   "
208929|NCT00577707|"     The purpose of this study is to try to improve the odds that your cancer may be cured.     Pemetrexed and cisplatin are traditional chemotherapy drugs that have been shown to help some     patients with non-small cell lung cancer. Many different types of cancer cells, including     your type of lung cancer, have a protein on their surface called the epidermal growth factor     receptor (EGFR). Stimulation of these receptors can result in growth of cancer cells and     progression of cancer. In addition, your cancer has an EGFR mutation (a specific abnormality     in the genetic code for EGFR). Erlotinib (TarcevaTM) is a newer drug which has shown benefit     for patients with lung cancers that contain an EGFR mutation. Erlotinib works by blocking     this receptor and depriving the cancer cells of this message to grow and multiply. In this     research study, we plan to combine erlotinib with traditional chemotherapy drugs to see if     the combination works better than chemotherapy alone.      The main purpose of this research is to find out the good and bad effects that the     combination of these 3 drugs (pemetrexed, cisplatin and erlotinib) has when given to patients     with early stage non-small cell lung cancer before surgery. A secondary purpose is to find     out the good and bad effects that occur when erlotinib is given to patients after surgery for     2 years.   "
208930|NCT00577720|"     To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after     breakfast, to a 35 mg immediate-release tablet, administered according to labeling     instructions.   "
208931|NCT00577733|"     Asthma is more frequent in obese women, but the mechanisms underlying the causes of this     increased frequency are unknown and are different from usual asthma pathophysiology     (associated with allergy). Obesity is known to influence ventilation; our hypothesis is that     the normal variability of ventilation is decreased in obese patients, and that this decrease     is responsible for an increased reactivity of their airway to non specific stimuli. In this     observational study, breathing variability will be studied using polygraphy (an investigation     that is made in these women to detect nocturnal apneas), and airway reactivity is studied     between pulmonary function tests that are made before bariatric surgery.   "
208932|NCT00577746|"     The goal of this prospective study is to determine the clinical and economic impact of     endoscopic ultrasound (EUS) in staging NSCLC. Aims: 1) Determine the accuracy of EUS in     staging NSCLC 2) Measure 5-year survival 3) Measure quality of life in patients that undergo     surgery 4) Determine the cost benefit of EUS in staging NSCLC.   "
208933|NCT00577759|"     The purpose of this study is to evaluate the impact of strategies to develop and foster the     relationship between primary care practices and community resources to address specific     unhealthy behaviors (tobacco use, poor nutrition, and lack of physical activity).   "
208934|NCT00577772|"     The primary purpose of this exploratory study is to measure orocecal transit time using the     SmartPill ambulant capsule technology and to compare this with the lactulose hydrogen breath     test. Additionally, the ability of the SmartPill GI Monitoring System to discriminate between     healthy human subjects and patients with small bowel bacterial overgrowth will be explored     using analyses of both pH and pressure patterns within the stomach and small intestine. The     study will be performed in both normal subjects and patients with and without small bowel     bacterial overgrowth.   "
208935|NCT00577785|"     The objective of this study is to obtain bladder tissue specimens from patients otherwise     undergoing cystectomy for use in research and training of personnel at Tengion, Inc.   "
208936|NCT00577798|"     RATIONALE: Diagnostic procedures, such as cardiac magnetic resonance imaging, may help     doctors detect early changes in the heart caused by chemotherapy.      PURPOSE: This clinical trial is studying how well cardiac magnetic resonance imaging works in     patients with newly diagnosed non-Hodgkin lymphoma or Hodgkin lymphoma receiving doxorubicin.   "
208937|NCT00577811|"     The purpose of this study is to find out how people's needs are being met and what people do     about problems with treatment, symptoms, substance use, mental health, and social services.     We are also interested in finding out about changes that people make in their health care     team and the reasons for making those changes.   "
208938|NCT00577824|"     This long term, placebo-controlled trial is intended to assess the efficacy and safety of     exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with     oral antidiabetic(s) but not well controlled.   "
208939|NCT00577837|"     A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized,     Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150,     and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with     Low Bone Mineral Density.   "
208940|NCT00577850|"     The primary objective of this study is to compare the urinary excretion of 14C-labeled     risedronate and alendronate over 28 days.   "
208941|NCT00577863|"     This study is being conducted to collect information from subjects with osteoporosis     regarding their experience using the Forteo B Pen to self-administer teriparatide in the     community setting. Information collected during this study will be used to assess the need     for changes to the Forteo B-Pen User Manual and patient educational tools. Additionally, the     information generated from patients during this trial will be reviewed to assess the     acceptability of the Forteo B Pen for commercial launch.   "
208942|NCT00577876|"     For patients with Prostate Cancer advances in medical technology have enabled us to identify     accessory (additional) pudendal arteries (called APA) while performing a laparoscopic     radical prostatectomy (a scope with a video camera is used during the surgery). APAs running     near the prostate gland are identified in approximately 1 in 3 to 4 patients. However, large     APAs, like the ones looked for in this study, are identified in 15-18% of all patients. These     arteries are preserved more than 80% of the time, depending on their size and location.With     this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as     well as the amount supplied.   "
208943|NCT00577889|"     This randomized phase II trial is studying three different schedules of gemcitabine     hydrochloride and tanespimycin to see how well they work in treating patients with stage IV     pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and     tanespimycin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells   "
209022|NCT00578968|"     This study is being done to examine the influence of Tiotropium (good or bad) on heart     function at rest and during exercise in patients with moderate to severe chronic obstructive     pulmonary disease (COPD).   "
208945|NCT00577915|"     The purpose of this study is to provide physicians with additional information not available     with standard imaging methods for breast disease.      As part of the MRI examination ordered by your physician, a new method of analyzing the     images or pictures will be used. This new method is called spectroscopy and is used routinely     on other parts of the body such as the prostate and brain. Pictures produced with this     sequence may look slightly different than the regular MRI pictures. Using spectroscopy data,     it may be possible to distinguish benign conditions of the breast from malignant tumors and     provide more precise information than can be obtained with regular MRI.   "
208946|NCT00577928|"     For the main goal - the accuracy of calprotectin for the diagnosis of IBD - calprotectin     levels will be compared between patients with and without a diagnosis of IBD and the     sensitivity, specificity and accuracy will be determined. For the secondary aim - the     correlation between calprotectin levels and disease activity - in patients with IBD selected     from this cohort, we will determine the association between calprotectin levels and clinical     IBD score, serological markers (WBC, Hgb, Platelets, ESR, CRP, Albumin), endoscopic (disease     score, pathological activity) and radiological features (bowel wall thickening, enhancement,     edema, mesenteric inflammation).   "
208947|NCT00577954|"     Stroke, traumatic head injury, subarachnoid hemorrhage and cerebral anoxia are main causes of     a coma condition implying severe brain damage and thus, poor prognosis. Clinicians are often     in need for a tool able to predict the awakening of these patients. Multimodal MRI,     associating the traditional morphological sequences with spectroscopy-MRI (MRS) and the     diffusion tensor imaging, could provide such a prediction.   "
208948|NCT00577967|"     To investigate using the drug gabapentin to relieve the intense pruritic sensation associated     with chronic renal failure patients undergoing peritoneal dialysis.   "
208949|NCT00577980|"     Primary Objective:      1. To assess the prostate-specific antigen (PSA)-response (50% decline) to Testosterone     Replacement Therapy (TRT) in men with intermediate and good-risk Castration-Resistant     Prostate Cancer (CRPC).      Secondary Objectives:        1. To assess the objective response and time-to-progression with TRT in CRPC.        2. To assess serial changes in quality of life with TRT in these CRPC subsets.        3. Translational: To study kinetics of circulating tumor cells with TRT and molecular          correlates of response to TRT in CRPC.   "
208950|NCT00577993|"     The goal of this clinical research study is to compare chemotherapy given with rituximab to     chemotherapy followed by rituximab. The safety of both treatment schedules will be studied.     Laboratory tests of genetic changes in blood and bone marrow before and during the study will     also be monitored.   "
208951|NCT00578006|"     Cancer patients may develop side effects during treatment, such as nausea, pain, fatigue,     diarrhea, constipation, or shortness of breath. These symptoms may be due to the cancer     itself, or due to treatments like chemotherapy drugs or radiation therapy. Doctors and nurses     often ask patients about their symptoms, because an important part of cancer treatment is to     make patients feel as well as possible. If patients do not feel well, the investigators may     need to change the way the investigators are treating you or prescribe therapies that will     decrease your symptoms. The best way to find out how you are feeling is to ask you directly.      However, during your time between appointments the investigators may not be able to ask you     how you are feeling on a regular basis. In addition, even at an appointment, there may be     symptoms that the investigators do not have a chance to discuss.      The investigators are interested in developing new ways to ask patients about how they are     feeling, using the Internet. A special new website called STAR (Symptom Tracking and     Reporting for Patients) has been developed to help patients record this information, so that     their doctors and nurses can review it during clinic appointments. This study is designed to     help us see if STAR is a helpful way for us to keep track of information about patients'     symptoms and quality of life.   "
208952|NCT00578019|"     The purpose of this study is to compare patient outcomes for the Less Invasive Stabilization     System (LISS) (Synthes {USA}, Paoli, PA, USA), a minimally invasive plating system used in     the treatment of supracondylar femur fractures, with patient outcomes for the Supracondylar     Nail (Smith & Nephew Inc, Memphis, TN, USA), a retrograde intramedullary nail.   "
208953|NCT00578032|"     The goal of this study is to better understand the changes in symptoms and overall quality of     life after head and neck surgery and reconstruction. Quality of Life means how you feel     about your life as a result of your disease and its treatment. Learning about changes in     patients' quality of life will help doctors and future patients make more informed treatment     decisions.   "
208954|NCT00578045|"     The researchers want to find out if subjects treated on this study will achieve long term     bone marrow recovery (engraftment) and if their tumors will respond to this treatment.   "
208955|NCT00578058|"     Millions of Americans suffer from tinnitus. However, there is no widely accepted treatment     that has been shown to be effective in controlled investigations. The purpose of this study     is to evaluate the effectiveness of Tinnitus Retraining Therapy (TRT). This study will     investigate the contributions of counseling, the use of hearing aids and sound generators,     and the importance of setting masking noise to a particular level. All groups will receive     the same Counseling. In pilot studies we have developed a picture-based counseling protocol.     The results of this study will determine if TRT is more effective than masking or counseling     alone.   "
208956|NCT00578071|"     The primary purpose of this trial is to define the maximum tolerated and/or recommended phase     II dose of the combination of panitumumab, oxaliplatin and capecitabine in patients     undergoing radiation therapy for carcinoma of the thoracic esophagus or gastroesophageal     junction. An additional primary objective is to describe the frequency and nature of grade     III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include     describing 1-year disease-free survival and overall survival rates as well as to estimate     clinical and pathologic complete response rates associated with this regimen.   "
208981|NCT00578409|"     We seek to improve the predictive accuracy of the nomogram to predict survival for patients     with castrate mets disease through the addition of pathological data, the results of     automated machine vision based image analysis of H&E stained tumor tissue developed at Aureon     Biosciences,and molecular biomarker studies (25 markers) determined by immunohistochemistry     on tissue microarrays prepared from paraffin-embedded tumor.   "
220640|NCT00741351|"     This protocol, NeuroMorfeo, aims to assess equivalence between volatile and intravenous     anesthetics for neurosurgical procedures.   "
208960|NCT00578123|"     The goal of the study is to look at surgical recovery and quality of life for men who have an     open versus robotic-assisted laparoscopic radical prostatectomy (RP). RP is a procedure that     removes the prostate gland. We want to see how long it will take you to return to health and     strength after surgery. Quality-of-life (QOL) means how you feel about your life and your     treatment of prostate cancer. The QOL surveys ask questions about your sexual, urinary and     bowel functions. We will also ask questions about your use of health care services,     out-of-pocket-spending on medical care and about your return to work, in order to learn about     the financial impact of prostate cancer treatment. We hope that the surveys will help show     how prostate cancer treatments affect your daily life after surgery.   "
208961|NCT00578136|"     Umbilical hernia repair is a common painful outpatient procedure performed in children. Often     analgesia for this procedure is provided by using local infiltration of the surgical site by     the surgeons and perioperative opioids and NSAIDS both IV and orally. The use of opioids can     cause adverse side effects which include, but are not limited to nausea, vomiting, itching,     and respiratory depression, etc. The rectus sheath block can be performed in these patients     to decrease their post operative pain.   "
208962|NCT00578149|"     This study is being done to learn what effects (good and bad) bevacizumab in conjunction with     carboplatin/paclitaxel and radiation therapy has on patients with non-small cell lung cancer     (NSCLC).   "
208963|NCT00578162|"     To describe the range of services available to cancer survivors in the NYC area.      To determine organizations' need for assistance to enhance services for survivors.   "
208964|NCT00578175|"     The purpose of this observer blinded study is to provide information on vaccine     immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when     administered with Hepatitis A vaccine and Pneumococcal vaccine.   "
208965|NCT00578188|"     The purpose of this study is to determine if Chlamydial infections persist in the rectum of     females who have had a sexually transmitted infection of Chlamydia.   "
208966|NCT00578201|"     This phase II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when     given together with Cetuximab and radiation therapy and radiation therapy to see how they     work in treating patients with stage III esophageal cancer.   "
208967|NCT00578214|"     Midazolam is an approved sedative medication used for medical procedures. This study was     being done to document the safety and efficacy of midazolam in improving anxiety, heart rate,     and blood pressure in patients prior to undergoing Mohs micrographic surgery for the     treatment of skin cancer (basal cell carcinoma or squamous cell carcinoma). Midazolam may     make a patient relaxed and sleepy, and lower blood pressure. These effects last for about 2     hours.      This study had two parts. In the first part, eligible patients were randomized to either     receiving one standard dose of midazolam syrup or placebo syrup before their surgery, with     neither the patient nor the study team knowing which patient received the study drug. In the     second part, patients who were not eligible to participate in the randomized study or who     refused to participate in the randomized study were enrolled in a prospective arm where they     knew they were receiving midazolam syrup. In the prospective arm, the doses were based on the     patient's weight, and patients were given additional doses of midazolam syrup as necessary to     control their anxiety.      The primary hypothesis of this study was that a single dose of oral midazolam syrup to     patients prior undergoing outpatient Mohs micrographic surgery for skin cancer would result     in lower anxiety scores at 60 minutes compared to placebo. In addition, the second hypothesis     of this study was that patients given oral midazolam would have the rate of adverse events     that was not worse than 25% higher than in the placebo group.   "
208968|NCT00578227|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and     thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical     cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent     vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and     immunogenicity of co-administering a commercially available vaccine with GSK Biologicals'     HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine     alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.   "
208969|NCT00578240|"     The Genitourinary Oncology/Urology Services at Memorial Sloan-Kettering Cancer Center (MSKCC)     participates in research for the control, treatment, and cure of cancer. The purpose of this     study is to collect normal and cancerous tissues, in addition to blood, and other body fluid     samples from men with prostate cancer or prostatic disease. These samples may be stored for     future use or used immediately by researchers who study prostate cancer and try to find     better ways to diagnose, prevent, and treat it. We will look for genetic changes and protein     markers on these cells. We hope to learn more about what makes some people get prostate     cancer, why some cancers are more aggressive than others, and why some cancers respond to or     resist different treatments. We may also try to grow the tumor cells in the lab. We may find     a new treatment for prostate cancer based on this research.   "
208970|NCT00578266|"     For patients with severe aplastic anemia (SAA) who have failed to respond to     immunosuppressive therapy and lack an HLA identical family member, our objectives are to make     an initial assessment of the safety and efficacy of allogenic stem cell transplantation from     either a matched unrelated donor or a mismatched reacted donor using the conditioning regimen     of Cytoxan, reduced total body irradiation (TBI) and Campath IH. The principle measures of     safety and efficacy will be :        1. Patient survival probability at 100 days, 1 year and 2 years.        2. Incidence of graft versus host disease (GVHD), as well as incidence of acute GVHD and          chronic GVHD within 6 months and 2 years.        3. Engraftment at 6 months, 1 year and 2 years   "
208971|NCT00578279|"     The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic     ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or     unresectable pancreatic adenocarcinoma.      Hypotheses:        1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving          pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma.        2. Effective pain relief obtained from EUS-CPN will be related to better quality of life          (QOL)   "
221491|NCT00743873|"     To check the influence of injected platelet-rich plasma (PRP) on the healing of medial     retinaculum and the redaction in recurrent dislocation of the patella.   "
208972|NCT00578292|"     Patients have severe beta-thalassemia or one of the thalassemia variants. Thalassemia is a     hereditary disease in which the bone marrow produces abnormal red blood cells that have a     shorter life span than normal red blood cells. Because of that, the patient has chronically     low red blood cell numbers (anemia) and need regular blood transfusions to help the patient     feel better and to help prevent damage to important organs such as the heart. The following     treatments are currently available to patients: lifelong blood transfusions and drugs that     help remove iron from the body, and long-term antibiotics to prevent infections. These     treatments are difficult for patients to take, and do not stop the effects of the disease.      Currently, the only treatment that may cure thalassemia is bone marrow or blood stem cell     transplantation. Special blood or bone marrow cells from a healthy person might allow the     bone marrow to create healthy cells, which will replace the abnormal red blood cells of     thalassemia. There is a lot of experience using special blood or bone marrow cells from a     healthy brother or sister who is the same HLA (immune) type. For patients who do not have     such a donor in the family, an unrelated volunteer donor can be used. It is important for the     patient to realize that this kind of transplant can have more problems than a transplant from     a brother or sister.      Because we do not know the long-term effects of this treatment and because this type of     transplant has not been used often for people with thalassemia, this is a research study. We     hope, but cannot promise, that the transplanted marrow/stem cells will produce healthy cells     and the patient will no longer have severe thalassemia.   "
208973|NCT00578305|"     This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of     progression of structural joint damage in participants with active rheumatoid arthritis who     had an inadequate clinical response to methotrexate. Participants were randomized to receive     rituximab 500 mg intravenously (iv), rituximab 1000 mg iv, or placebo iv on days 1 and 15     every 24 weeks in the main study; all participants received concomitant methotrexate at a     stable dose of 12.5-25 mg/week throughout the study. Further courses of rituximab were     provided to eligible participants. Structural joint damage was assessed by magnetic resonance     imaging (MRI) at baseline and at intervals during the study.   "
208974|NCT00578318|"     The purpose of this study was to better understand how African American families identify and     treat emotional and behavioral concerns associated with depression in their adolescent youth.     The goals of the study included (a) identifying factors associated with participation in     psychiatric research and treatment and (b) developing an intervention to increase     participation in psychiatric research and treatment.   "
208975|NCT00578331|"     The purpose of this study is to determine whether olopatadine nasal spray is safe and     effective when used for up to one year by patients with perennial allergic rhinitis.   "
208976|NCT00578344|"     Patients are being asked to participate in this study because they have severe sickle cell     anemia (SCD) with or without the beta thalassemia trait. Sickle cell anemia is an illness     where the red blood cells change shape and can clog up blood vessels. This keeps the body     from getting the oxygen it needs. Thalassemia is when the body does not make enough     hemoglobin, something that helps the oxygen get to the places it needs to go in the body. The     patient may or may not need to get regular blood transfusions (getting more blood) to improve     their quality of life (feel better) and prevent organ damage (problems with the brain, heart,     lung, kidney, and gonad, for example.). The transfusions can also cause problems, including     iron overload (too much iron in the blood), which can be fatal (patients can die) without     regular deferoxamine shots. Even with the best usual treatments, people with thalassemia or     SCD die sooner. There is no proven cure.      We would like to treat patients using bone marrow transplantation, a treatment that has been     used for people with SCD. The transplant uses healthy matched bone marrow. This comes from     a brother or sister who does not have sickle cell disease or severe thalassemia. If the     treatment works, the sickle cell disease or thalassemia may be cured. This treatment has been     used to treat patients with sickle cell disease or thalassemia. It has worked in most cases.     We hope, but cannot promise, that the transplanted marrow will make healthy cells, and     patients will not have sickle cell disease or severe thalassemia anymore.      We do not know what effect this treatment will have on the damage that has already been done     by the disease. Finding that out is the main reason for this study. Currently, very little     has been reported about organ function after bone marrow transplants in patients with sickle     cell anemia.   "
208977|NCT00578357|"     The main aim of this randomized controlled trial is to evaluate the sustained efficacy of a     personalized feedback intervention for problem gamblers. Adult problem gamblers who express     an interest in self-help materials for gamblers will be recruited from respondents to a     random digit telephone survey, which also collects the baseline data. Subjects will be     randomly assigned to receive personalized feedback about their gambling, or to a waiting list     control group.      Three-month, six-month, and 12-month follow-up surveys will be conducted by mail to assess     gambling over the intervening periods. Collaterals will be requested as part of the 12-month     follow-up and interviewed by telephone. Gambling at three- six- and 12-months will be     compared between the groups. Change in perception of gambling norms and sex will be tested as     mediational and moderating variables.   "
208978|NCT00578370|"     Ciclosporin is a cyclic nonribosomal polypeptide of 11 amino acids produced by the fungi     Tolypocladium inflatum and Cylindrocarpon lucidum. Ciclosporin is a highly efficient     immunosuppressant drug widely used in post-allergenic organ transplant to reduce the activity     of the subject's immune system and so the risk of organ rejection. Apart from transplant     medicine, ciclosporin is also used in the treatment of autoimmune diseases like psoriasis and     infrequently in rheumatoid arthritis and related diseases, although it is only used in severe     cases.      Ciclosporin blocks the lymphocytes, especially the T-lymphocytes, in the G0- or G1-phase of     the cell cycle. Moreover it inhibits the production and release of lymphokines including     interleukin 2 or the T-cell growth factor.      Generally ciclosporin is taken orally (capsule or solution)or by injection in doses of 1.5 to     5.5 mg/kg/day. In the topical cutaneous emulsion presented here, ciclosporin is available at     a concentration of 0.5 and 1.5%.      The purpose of this study is the demonstration of antipsoriatic efficacy and tolerability of     topical cutaneous ciclosporin in subjects with psoriasis vulgaris.   "
208979|NCT00578383|"     This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some     of the symptoms of depression in bipolar disorder or major depression.   "
208980|NCT00578396|"     This study is designed to investigate the dietary influence of grapes in colon cancer     prevention. A natural compound found in the skin of grapes, resveratrol, may protect against     cancer by acting as an antioxidant (a chemical compound or substance that helps reduce     damages due to oxygen). This compound is known to block colon cancer cell lines from growing     in the laboratory. The purpose of this study is to determine the minimum amount of     resveratrol-rich fresh red grapes needed to exhibit such signs of prevention.   "
211941|NCT00624624|"     The purpose of this study is to determine the natural course of the androgen profile after     bariatric surgery in men with obesity related hypogonadotropic hypogonadism.   "
208982|NCT00578422|"     Peripheral Artery Disease involves a buildup of fatty deposits (plaque) within blood vessels     that can restrict blood flow. Patients who have PAD and claudication (pain in legs during     exercise due to poor blood circulation) may be eligible for this clinical trial. Three     primary hypotheses will be tested in this study: (1) IVUS (Intravascular Ultrasound)combined     with advanced digital image and signal processing provides a sensitive method to determine     plaque geometry and composition in the human peripheral artery wall; (2) IVUS can discern     specific arterial wall morphology, providing data that can be used to identify plaques that     predispose the patient to late complications; and (3) IVUS-derived plaque structure can be     used to predict responders and non-responders to pharmacologic therapy and percutaneous     endovascular interventions. These hypotheses will be tested as follows: (1) custom engineered     IVUS analysis software will be used to describe the geometry, composition, and spatial     component relationships of the vessel, (2) the morphology of lower extremity arterial plaque,     as determined by IVUS, will be correlated with baseline clinical characteristics of subjects,     and (3) the effects on plaque morphology after long term treatment with antihyperlipidemics     will be determined.   "
208983|NCT00578435|"     The purpose of this study is to determine and confirm the role of bone marrow transplantation     in the treatment of disorders of the red cell and hemoglobin including sickle cell anemia,     thalassemia and diamond blackfan anemia.   "
208984|NCT00578448|"     The purpose of this study is to assess the pharmacokinetics and safety of belatacept in de     novo renal transplant subjects treated with belatacept-based immunosuppressant medication   "
208985|NCT00578461|"     Patients are being asked to participate in this study because they have a cancer in their     blood (such as leukemia or lymphoma) or myelodysplastic/myeloproliferative (pre-leukemia). We     suggest a treatment that might help them live longer without disease than other treatment     plans would. This treatment is known as a stem cell transplant. We believe this may help the     patient as it allows us to give much stronger doses of drugs and radiation to kill the     diseased cells than we could give without the transplant. We also think that the healthy     cells may help fight any diseased cells left after the transplant.      Stem Cells are special mother cells that are found in the bone marrow (the spongy tissue     inside bones), although some are also found in the bloodstream (peripheral blood). As they     grow, they become either white blood cells which fight infection, red blood cells which carry     oxygen and remove waste products from the organs and tissues or platelets, which enable the     blood to clot. For the transplant to take place, we will collect these stem cells from a     donor (a person who agrees to donate these cells) and give them to the patient. The patient     has a type of blood cell cancer or other blood problem that is very hard to cure with     standard treatments and they will receive a stem cell transplant (SCT). If they have a     brother or sister that is a perfect match and agrees to donate, the stem cells will come from     him/her. Before the transplant, two very strong drugs plus total body irradiation will be     given to the patient (pre-conditioning). This treatment will kill most of the blood-forming     cells in the bone marrow. We will then give the patient the healthy stem cells. Once these     healthy stem cells are in the bloodstream they will move to the bone marrow (graft) and begin     producing blood cells that will eventually mature into healthy red blood cells, white blood     cells and platelets.      Also, we will ask permission to draw blood from the patient so that we can measure the number     of certain blood cells called T regulatory cells. T regulatory cells are special immune cells     that can control or regulate the body's immune response. We want to determine whether T     regulatory cells are important participants in graft versus host disease (GVHD), infection     and relapse. In GVHD, certain cells from the donated marrow or blood (the graft) attack the     body of the transplant patient (the host). GVHD can affect many different parts of the body.     The skin, eyes, stomach and intestines are affected most often. GVHD can range from mild to     life-threatening. We do not know whether T regulatory cells can modify these conditions. We     want to measure these T regulatory cells and learn if these cells do influence these     conditions. If we learn that T regulatory cells do affect these conditions, then it may be     possible to modify these cells for the benefit of transplant patients.   "
208986|NCT00578474|"     The purpose of this study is to determine if an otic formulation is safe and effective in     treating middle ear infections in patients with ear tubes.   "
208987|NCT00578500|"     Success rates of cancer treatment have increased significantly resulting in many girls and     young women who are treated now and will be cancer survivors. Nevertheless, cancer treatment     may result in long term side effects. Damage to the ovaries may result in serious difficulty     to become pregnant in the future. The risk of this happening depends, among others upon     patient's age, disease and type of treatment she undergoes. Medical research is continuously     looking into ways to preserve female fertility by using less toxic protocols. Yet, keeping     your eggs outside the body during treatment is an interesting option which as is routine for     boys preserving sperm before cancer treatment. This research attempts to freeze eggs either     in the ovarian tissue or individually.   "
208988|NCT00578526|"     The purpose of this study is to find out if SU011248 works and if it is safe in patients with     advanced transitional cell carcinoma.   "
208989|NCT00578539|"     Patients have a type of blood cell disorder that is very hard to cure. We are now suggesting     a treatment that might help patients live longer without disease than other treatment plans     would. This treatment is known as a stem cell transplant. We believe this may help patients     as it allows us to give much stronger doses of drugs and radiation to kill the diseased cells     than we could give without the transplant. We also think that the healthy cells may help     fight any diseased cells left after the transplant.      Stem Cells are special mother cells that are found in the bone marrow (the spongy tissue     inside bones), although some are also found in the bloodstream (peripheral blood). As they     grow, they become either white blood cells which fight infection, red blood cells which carry     oxygen and remove waste products from the organs and tissues or platelets, which enable the     blood to clot. For the transplant to take place, we will collect these stem cells from a     donor (a person who agrees to donate these cells) and give them to recipient. Patients do     not have a sibling that is a perfect match, so the stem cells will come from a donor who is     the best match available. This person may be a close relative or an unrelated person whose     stem cells best matches the patients, and who agrees to donate stem cells. Before the     transplant, two very strong drugs plus total body irradiation will be given to the patient     (pre-conditioning). This treatment will kill most of the blood-forming cells in the bone     marrow. We will then give the patient the healthy stem cells. Once these healthy stem cells     are in the bloodstream they will move to the bone marrow (graft) and begin producing blood     cells that will eventually mature into healthy red blood cells, white blood cells and     platelets.      This research study will also use CAMPATH-1H as a pre-treatment. CAMPATH-1H is an antibody     against certain types of blood cells. CAMPATH-1H is important because it stays active in the     body for a long time after infusion, which means it may work longer at preventing GvHD     symptoms.      The stem cell transplant described above is considered to be standard treatment. We would     like to collect additional blood as described below in order to evaluate how the immune     system is recovering.      We are asking permission to draw blood from the patient so that we can measure the number of     certain blood cells called T regulatory cells. T regulatory cells are special immune cells     that can control or regulate the body's immune response. We want to determine whether T     regulatory cells are important participants in graft versus host disease (GVHD), infection     and relapse. In GVHD, certain cells from the donated marrow or blood (the graft) attack the     body of the transplant patient (the host). GVHD can affect many different parts of the body.     The skin, eyes, stomach and intestines are affected most often. GVHD can range from mild to     life-threatening. We do not know whether T regulatory cells can modify these conditions. We     want to measure these T regulatory cells and learn if these cells do influence these     conditions. If we learn that T regulatory cells do affect these conditions, then it may be     possible to modify these cells for the benefit of transplant patients.   "
209023|NCT00578981|"     To develop a decision aid to support the decision to use (or not use) bisphosphonates in     postmenopausal women at risk for osteoporotic fractures, and to assess the impact of the     decision aid on start and six month adherence to bisphosphonates.   "
209024|NCT00578994|"     The purpose of this study is to collect information on complications and survivorship of     patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites     in the United States.   "
209129|NCT00587938|"     Measurement of brain natriuretic peptide (BNP) in dyspneic patients increases diagnostic     accuracy for congestive heart failure (CHF). Limited information is available regarding     economic outcomes attributable to BNP assay. The aim of this study was to assess the economic     impact of BNP assay in elderly dyspneic patients presenting to the emergency department (ED).   "
208990|NCT00578552|"     Gabapentin is an anti-epileptic agent that has shown preliminary evidence of efficacy for     improving symptoms of cocaine and alcohol withdrawal in pilot studies. Since the neurobiology     of alcohol, cocaine and nicotine withdrawal is similar, the preliminary evidence of efficacy     of gabapentin for symptoms of alcohol and cocaine withdrawal suggests, that gabapentin might     likely help nicotine withdrawal symptoms and thus tobacco abstinence. The effect of     gabapentin on two of the neurotransmitters, gamma-aminobutyric acid (GABA) and glutamate     further suggest a potential therapeutic mechanism for gabapentin in tobacco abstinence.     However, the exact mechanism of action of gabapentin is currently not known. We have recently     completed an open label pilot trial of gabapentin for tobacco abstinence involving 50     smokers. The findings from that study provide promising preliminary results and suggest that     further testing of gabapentin for helping cigarette smokers quit tobacco use is worth     pursuing. Overall, gabapentin is well tolerated and has low abuse potential.      Our goal is to evaluate novel, safe, acceptable, and effective therapies that may help     increase tobacco abstinence rates. Currently, no randomized trials testing the efficacy of     gabapentin for smoking abstinence have been published. While our previous study provides     promising evidence regarding the potential efficacy of gabapentin for smoking abstinence, an     additional dose ranging study is needed prior to pursuing a large randomized trial. The     primary aim of the dose ranging study will be to obtain additional evidence of efficacy, and     information on the optimal dose of gabapentin to employ in the larger randomized controlled     trial.   "
208991|NCT00578565|"     This study will examine the course of patients with progressive rheumatoid arthritis     associated interstitial lung disease (RA-ILD) treated with rituximab for safety and     progression-free survival at 48 weeks. Safety of rituximab therapy in this disease will be     assessed through patient history, physical exams and laboratory parameters.        -  Twelve male/or female patient with RA-associated lung disease (6 of each nonspecific          interstitial pneumonia (NSIP) and usual interstitial pneumonia (UIP) histological          subtype) will be enrolled        -  The study involves 12 visits over 48 weeks        -  Rituximab will be administered intravenously at Day 1 and Day 15 with repeat dosing at          six months.   "
208992|NCT00578578|"     To study the anti-inflammatory effects of marine omega-3 fatty acids, also known as n-3     polyunsaturated fatty acids (PUFA), we propose a randomized, double-blinded, prospective,     single-center trial to examine the effect of supplementary n-3 PUFA on serum high sensitivity     (hs) CRP levels.      Inclusion Criteria Age > 18 hs CRP >3mg/L and <10 mg/L      Exclusion Criteria      Active infection Systemic Inflammatory Disease Autoimmune disorders Systemic Lupus     Erythematosus (SLE) Rheumatoid Arthritis (RA) Systemic Sclerosis (Scleroderma) Sjögren's     Syndrome Behçet's Syndrome      The Vasculitis Syndromes Including:      Wegener's granulomatosis Temporal arteritis (Giant cell arteritis) Takayasu's arteritis     Henoch-Schönlein purpura Predominantly cutaneous vasculitis (hypersensitivity vasculitis)     Sarcoidosis Amyloidosis Currently on warfarin Cr > 2.0 Fish Allergy Pregnancy or     unwillingness to use some form of birth control in women of child-bearing age during the 8     weeks.      We will enroll 200 pts. at Willoughby Hills Family Health Center over a 2 month period 100     pts. will receive OMEGA-3, 100 pts. will receive placebo Drug is to be taken over 8 weeks Pt.     will return to Willoughby Hills in 8 weeks for a follow-up hsCRP. A brief questionnaire will     be completed by the nurse/pt, including vital signs at baseline and follow-up .      Primary Outcome:      hsCRP levels after 8 weeks of treatment with PUFA   "
208993|NCT00578591|"     This is a prospective, open-label pilot study in which 4 doses of Rituximab are administered     to patients who have developed SR-aGVHD following allogeneic hematopoietic transplant (AHT).     The study is designed to determine the overall survival at 180 days after treatment with     rituximab, and evaluates the safety and clinical response to rituximab in this study     population. Study entry: Patients must enter study on or before day +100 posttransplant.   "
208994|NCT00578604|"     The objective of this project is to further the development of a non-invasive optically based     NIR (Near Infrared) device to enable the quantitative diagnosis, monitoring and treatment     optimization of chronic wounds (especially diabetic) in a clinical setting. The end goal of     this project is a portable and compact device that would be simple to operate by minimally     trained health care personnel. Our animal studies have shown that the early healing of     chronic wounds can be characterized by absorption and scattering of light at near infrared     wavelengths ranging from 680 nm to 950 nm. If our project is successful we will be providing     the clinician the ability to predict if a wound is healing and if a particular treatment is     successful in accelerating healing before any changes are observed by wound size contraction     or other visible clinical signs. Our hope is that the fNIR optical device will provide     conclusive therapeutic treatment information as early as 5 weeks after initial evaluation,     before it would be obvious on gross examination of the patient.   "
208995|NCT00578617|"     The CABANA pilot study is designed to test the hypothesis that the treatment strategy of     percutaneous left atrial catheter ablation for the purpose of the elimination of atrial     fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or     anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.   "
208996|NCT00578630|"     The purpose of this study is to develop tests that will allow us to determine who will react     differently to the drugs used to treat cancer. We also want to see who will react differently     with preparing for a bone marrow transplant.   "
209009|NCT00578799|"     This study is being conducted in patients who have been diagnosed with ulcerative colitis     (UC), a form of inflammatory bowel disease (IBD) - a disease of the intestine.      The purpose of this study is to test the therapeutic (medical treatment) effects of daily     consumption of Kyo-Dophilus (a commercially available dietary supplement often used by     individuals with inflammatory bowel disease) on their UC. Kyo-Dophilus consists of three     probiotic bacteria (beneficial bacteria to help maintain the balance of good bacteria in the     intestine) to help treat inflammatory bowel disease caused by bad bacteria. Patients will     still be maintained on their clinical standard of care for their UC as part of their     participation in this study.   "
209025|NCT00579007|"     The purpose of this study is to learn more about women's decision to undergo prophylactic     surgery. This is removal of healthy organs in order to reduce risk of cancer. This study will     help us to understand what makes women decide whether or not to have this kind of surgery.   "
209026|NCT00579020|"     The purpose of the study is to determine whether Moxidex ophthalmic solution is safe and     effective in treating marginal corneal infiltrates.   "
208998|NCT00578656|"     Milk is the among the most common food allergens in infants and children. The majority of     children outgrow their allergies; however, the exact mechanisms by which food tolerance is     achieved are unknown. Strict avoidance of the offending food is currently the only known     therapy. However, subjects have been known to lose food hypersensitivity while frequently     ingesting small amounts of processed forms of the offending product. The purpose of this     study is to investigate whether ingestion of small amounts of processed milk protein will be     permitted without compromising the chances of either outgrowing milk hypersensitivity or     prolonging the time needed to achieve clinical tolerance.   "
208999|NCT00578669|"     The primary purpose of this study is to determine whether, among smokers with elevated     depressive symptoms, sequential antidepressant pharmacotherapy with fluoxetine (20 mg) begun     8 weeks prior to and extended throughout standard smoking cessation treatment with     transdermal nicotine patch (ST-TNP) will result in superior short-and long-term smoking     cessation outcomes compared to sequential pharmacotherapy with placebo medication combined     with ST-TNP. The secondary aim of the study is to test the hypothesis that, among smokers     with elevated depressive symptoms, sequential treatment with fluoxetine will result in lower     levels of depressive symptoms and negative mood and higher levels of positive mood     immediately prior to and throughout the course of smoking cessation treatment relative to the     placebo condition.   "
209000|NCT00578682|"     To evaluate the safety and tolerability of a single IV dose of MEDI-557.   "
209001|NCT00578695|"     The purpose of this study is to determine the safety and efficacy of lixivaptan in the     treatment of hyponatremia in patients with congestive heart failure.   "
209002|NCT00578708|"     The purpose of this feasibility study is to investigate the safety of the AMPLATZER®     Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous     Ventricular Septal Defects.   "
209003|NCT00578721|"     The purpose of this research study is to understand the effects of oral aspirin taken daily     with an arginine-restricted diet on certain colorectal cancer biomarkers in treated     colorectal cancer patients. Patients with colorectal cancer are at high risk for recurrence     and for development of secondary colorectal cancers in the future. Specific chemicals     (polyamines, prostaglandins) in the body referred to as biomarkers can be measured to help     understand a person's risk for developing colorectal cancer. Specific biomarkers associated     with colorectal cancer have been identified in prior laboratory studies. By measuring these     predefined biomarkers before and after the study intervention, we can assess how they are     affected by the intervention, and gain knowledge about their usefulness in colorectal cancer     patients on clinical trial.      This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily     with an arginine-restricted diet designed to reduce arginine intake by at least 30% during     the 12-week study period. The biomarkers will be obtained from patient by performing     endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy     (taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are     done to evaluate changes in tissue content that may relate to early events in colon cancer     formation. This was the procedure used to diagnose your condition initially. There will be 24     patients enrolled into this study performed through University of California Irvine Medical     Center.   "
209004|NCT00578734|"     Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated     in young children with acute respiratory failure who require mechanical ventilation (life     support), to determine if it is safe and if treatment with lucinactant will reduce the number     of days a child needs mechanical ventilation (life support).   "
209005|NCT00578747|"     Markings placed on the skin are an accurate representation of the underlying surgical cavity     and are adequate to use for patient setup for accelerated partial breast irradiation.   "
209006|NCT00578760|"     Aspirin (ASA) has been shown, in an animal model, to attenuate the ototoxic properties of     cisplatin. The researchers plan to investigate this in patients undergoing cisplatin     chemotherapy.      The researchers hypothesise that low-dose aspirin can prevent cisplatin induced ototoxicity     in the clinical setting.   "
209007|NCT00578773|"     The purpose of this study is to determine if an otic formulation is safe and effective in     treating peri-operative tube otorrhea.   "
209008|NCT00578786|"     AMB-320/321-E was designed to provide long-term, controlled monitoring of pulmonary arterial     hypertension (PAH) patients treated with ambrisentan (AMB) in order to properly define the     adverse event profile associated with this endothelin receptor antagonist (ERA), including     the incidence and severity of elevated serum liver function tests (LFTs). In addition, this     study continued the efficacy assessments of the previous studies, examined long-term AMB     treatment success, and compared long-term survival of subjects treated with AMB to the NIH     registry of patients with PAH.   "
209021|NCT00578955|"     The purpose of this study is to determine if AzaSite Plus is effective and safe for the     treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.   "
209010|NCT00578812|"     The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved     investigational device exemption (IDE) clinical trial conducted in the United States to     evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and     anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with     adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a     degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical     trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM     Cervical Disc or ACDF.   "
209011|NCT00578825|"     The study aims to examine whether the combination of Lopinavir/Ritonavir plus Ribavirin for     treatment of severe acute respiratory syndrome (SARS) is superior to placebo.   "
209012|NCT00578838|"     The purpose of this study is to see whether magnetic resonance (MR) techniques can detect     changes caused by chemotherapy in the livers of patients who have been treated for colorectal     cancer. Some patients who undergo chemotherapy for colorectal cancer may experience     side-effects in their livers. These side effects may influence further treatment options. If     this study finds that MR techniques detect changes in the liver due to chemotherapy, then MR     methods may eventually be used to help patients and physicians plan further treatment.   "
209013|NCT00578851|"     The objective of this study is to gather clinical and survivorship information for the     C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.   "
209014|NCT00578864|"     High-risk neuroblastoma is an aggressive childhood cancer that shows up as a lump or mass in     the belly or around the spinal cord in the chest, neck, or pelvis. Often the tumor has spread     around the body to the bones or to the soft center of the bone, called the bone marrow.     High-risk neuroblastoma often responds to treatment at first, but it frequently comes back     and may be even more difficult to treat.      Chemotherapy (drug treatments for cancer) is usually given at high doses in short bursts (3     to 5 days) followed by a few weeks of rest and recovery. This burst and recovery is called a     cycle and usually takes about 21 days. Some scientists and physicians have tried to give     chemotherapy at lower doses for more days, called metronomic chemotherapy. This method of     giving chemotherapy has been used to treat neuroblastoma that has failed more standard types     of treatment (relapsed neuroblastoma) and has shown some promise for those patients. One of     the reasons it may work is by killing the blood vessels that feed the tumor as well as     killing tumor cells themselves (the way that burst chemotherapy works). We think that giving     a burst of chemotherapy together with metronomic therapy may kill the tumor while decreasing     the side effects that we have seen in the past.      Treatment for high risk neuroblastoma usually occurs in 3 stages: induction, consolidation,     and maintenance. During the induction phase, patients will receive chemotherapy and possibly     more surgery to get rid of most of the tumor cells. Most of the chemotherapy drugs during     induction will be given in the standard burst method. One of the chemotherapy drugs,     etoposide, will be given in lower, metronomic doses. The doctors will study how the tumors     respond and the side effects patients have. After induction most childrens' tumors will have     disappeared, also called remission. These children will receive the second stage of treatment     called consolidation. During this stage, subjects will receive radiation treatments to the     tumor and then higher doses of chemotherapy. Because of the side effects of the high doses of     chemotherapy, we will collect and store some special blood cells (called hematopoietic stem     cells) early in treatment and keep them frozen. After the high doses of chemotherapy, these     cells will be thawed and given to the subject. . This is called hematopoietic stem cell     transplant (HSCT). The final stage of treatment, called maintenance, consists of a drug taken     by mouth for 6 months.      Surgery to remove large, or bulky, tumors is a standard part of treatment for high risk     neuroblastoma. A few children can have their main tumor removed before chemotherapy, but most     require the tumor to shrink first. Surgery has usually been scheduled for after 3 to 5 cycles     of therapy, but no one really knows how quickly the tumors are ready to come out. Because     chemotherapy has significant side effects that can change the risks of surgery, we will study     how early surgeries to remove tumors can happen.      This study is being done to evaluate the outcomes of disease response and survival in     children with high risk neuroblastoma treated on this regimen.   "
209015|NCT00578877|"     This multi-center contraceptive effectiveness and safety study of the SILCS diaphragm will     enroll approximately 450 couples at risk for pregnancy at six study sites in the U.S. The     study will randomly assign approximately 300 couples to use the SILCS diaphragm with     BufferGel and approximately 150 couples to use the SILCS diaphragm with Gynol II (2% N-9     gel). At two sites, a substudy involving colposcopy and microflora will be conducted in about     80 women (40 at each site). The primary objective of this study is to estimate the cumulative     6-month typical-use pregnancy probability for women using the SILCS diaphragm with a     contraceptive gel.   "
209016|NCT00578890|"     Osteomyelitis is a frequent complication of diabetic foot ulcer. Several therapeutic     strategies are used : medical treatment with antibiotics and foot offloading or surgical     treatment consisting in the resection of infected bone and a shorter antibiotic course. The     medical treatment risk is a longer healing time and a risk of bone infection relapse. The     surgical treatment risk is the ulcer relapse because of the modification of the foot     structure. These treatments need to be compared in terms of benefit/risk ratio. Our     hypothesis is : 1) in the medical treatment group a 7 month mean healing time of and a 15%     osteomyelitis recurrence rate;2) in the medical-surgical treatment group a 4 month mean     healing time and a 10% osteomyelitis recurrence rate.   "
209017|NCT00578903|"     Patients have been diagnosed with severe Aplastic Anemia that have not responded to treatment     with immunosuppressive therapy (drugs that suppress the immune system, for example Steroids).     The immune system is the system in the body that helps protect the body and fights bacterial,     viral and fungal infections.      Research studies have shown that patients with Aplastic Anemia have improved survival (may     live longer) after receiving a HLA (Human Leukocyte Antigen) identical sibling (brother and     sister) stem cell transplants. Patients who do not have matched siblings can undergo     immunosuppressive therapy, which has also shown to improve outcome. Unfortunately patients     who do not respond to immunosuppressive therapy usually die. The best chance of survival for     these patients is an HLA matched unrelated or mismatched related stem cell transplant as     described below.      Stem cells are created in the bone marrow. They mature into different types of blood cells     that people need including red blood cells which carry oxygen around the body, white blood     cells which help fight infections, and platelets which help the blood to clot and prevent     bleeding. For a matched unrelated stem cell transplant, stem cells are collected from a     person (donor) who is not related to the patient but who has the same type of stem cells. For     a mismatched related stem cell transplant, stem cells are collected from a donor who is     related to the patient and whose stem cells are almost the same as those of the patient but     not exactly. The patient then receives high dose chemotherapy. This chemotherapy kills the     stem cells in the patient's bone marrow. Stem cells that have been collected from the donor     are then given to the patient to replace the stem cells that have been killed.      The major problems associated with these types of stem cell transplants are graft rejection     (where the patient's immune system rejects the donor stem cells) and severe graft versus host     disease (GVHD), where the donors stem cell reacts against the patient's tissues in the body.   "
209018|NCT00578916|"     The purpose of this study is to determine how the human body processes and eliminates the     drug (BMS-690514.   "
209019|NCT00578929|"     A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal     spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6     to 11 years with a history of seasonal allergic rhinitis.   "
209020|NCT00578942|"     Allogeneic transplantation is used to treat many malignant and non-malignant diseases, though     the potential toxicities of the procedure remain high. We and others have shown that a less     toxic preparative regimen allows reliable allogeneic engraftment for allogeneic     transplantation.      The primary purpose of this treatment trial is to follow subjects undergoing allogeneic     transplantation for long term outcomes. The regimen used has been tested in our prior phase I     / II trial which has completed accrual. The issues of engraftment and rate of graft versus     host disease have been answered and our success has led to this regimen being a standard     approach for less toxic allogeneic therapy.   "
209027|NCT00584987|"     We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis     medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to     faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of     fluticasone furoate alone.   "
209028|NCT00585000|"     This will show if CP-675,206 can be administered safely as an intravenous infusion lasting     one hour. CP 675,206 already has been administered to 835 subjects over 1.0 - 7.5 hours.   "
209041|NCT00585182|"     Deep vein thrombosis(DVT) is a common complication in hospitalized medical patients.     Consensus guidelines recommend using medications such as heparin or low-molecular-weight     heparins (LMWH) to prevent DVT in these patients. Generally, these medications are given in a     fixed dose that is the same for everyone. The appropriate dose of medication in patients with     severe obesity is uncertain. There is some evidence that the use of standard fixed-doses in     severely obese patients may not provide adequate protection against DVT. The purpose of this     study is to evaluate a weight-based dose(0.5 milligrams per kilogram of body weight) of the     commonly prescribed LMWH, enoxaparin in severely obese patients to determine if predictable     levels of blood thinning can be achieved. We hypothesize that dosing enoxaparin 0.5mg/kg once     daily in severely obese patients will lead to predictable blood levels.   "
209381|NCT00593684|"     The purpose of this study is to test the safety of silver alginate (Algidex™) dressing in     VLBW infants in preparation for a large efficacy trial.   "
209029|NCT00585013|"     Each year, there are over 400,000 cardiac surgical operations performed in the United States;     of which 10,000 are performed on children. These operations are made possible by the use of     the heart-lung bypass machine, also known as cardiopulmonary bypass. This machine allows for     the body to be supported while the heart is repaired. While this machine has been life     saving, it has risks and can lead to a variety of complications.      One such complication results from the fact that the patient's blood is exposed to the     foreign material of the machine, such as plastic tubing. In nearly all cases of cardiac     surgery, this leads to a whole body response in the patient following the operation. This     response, inflammation, is characterized by alterations in the function of the heart and     lungs, fever, fluid retention, and bleeding disorders in the postoperative period. While this     is usually temporary and self limiting, significant morbidity occurs in approximately 1-2% of     cases where this inflammatory response is present. Additionally, children appear to be more     susceptible to this response. This can lead to significant postoperative complications that     are not associated with the actually surgical procedure performed on the heart.      The exact cause of this response is not fully understood. However, it is important to     understand the triggers, timing, and pattern of this complex inflammatory response in order     to modify or arrest it. Unlike other situations associated with this type of whole-body     inflammatory reaction such as trauma or overwhelming infection, cardiac surgical teams have     the advantage of knowing when the trigger will occur (i.e. during the cardiac operation) and     hence have the opportunity for preemptive intervention in an effort to minimize the response.     One such effort is the focus of this proposal.      Nitric oxide (NO) is a gas that has been used for years in the treatment of lung disease in     infants. It has been life saving and safe. Recently, it has been investigated for its     anti-inflammatory effects outside the lungs. We propose delivering NO to the source of the     greatest inflammation in cardiac surgery, the cardiopulmonary bypass machine. It is our     intention to show that in doing so; we can minimize the inflammation found in the first 24     hours following cardiac surgery in children. If we are correct, the reduction of this     inflammation will result in less damage to other organs of the child's body and improved     outcome following surgery.   "
209030|NCT00585026|"     This is a research study designed to test the utility of D-shaped bifocal lenses and PRIO     Computer Lenses for persons using a computer. We hypothesize that lenses specially designed     for computer use may allow more comfortable and productive work on a computer.   "
209031|NCT00585039|"     The purpose of this study is to determine in a large, double-blind, randomized, prospective     pediatric clinical trial whether the use of continuous levalbuterol (Xopenex) in addition to     standard emergency department treatment for acute asthma exacerbations will improve the     Forced Expiratory Volume in 1 sec (FEV 1) compared to the use of continuous racemic     albuterol. The secondary objective is to correlate clinical (hospitalization rates and     clinical asthma scores) with plasma levels of (S)-albuterol.   "
209032|NCT00585052|"     The purpose of this study is to find out if the treatment combination of paclitaxel and     lovastatin is more effective than the currently available chemotherapy for refractory or     relapsed ovarian cancer. This research is being done to improve on currently available     chemotherapy for ovarian cancer.   "
209033|NCT00585065|"     To collect information on pediatric patients receiving Cardiac Resynchronization Therapy     (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart     failure.   "
209034|NCT00585078|"     There are limited treatment options available for patients with advanced pancreatic ductal     adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety     of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced     and metastatic PDAC treated in the first and second lines.   "
209035|NCT00585091|"     There is now strong evidence from clinical trials that carvedilol therapy in heart failure is     superior to therapy with metoprolol. Not only does carvedilol have superior effects on lipid     profiles, insulin sensitivity, renal blood flow, and reversal of pathologic remodeling but     also its use is associated with fewer deaths compared to metoprolol. These facts make it     important to carefully define how metoprolol and carvedilol are pharmacologically different.     One potential difference is α1-AR antagonism. If we demonstrate that these α1-AR effects are     preserved with chronic therapy, then α1-AR blockade may have an important role in carvedilol     favorably altering the natural history of heart failure. On the other hand, if we demonstrate     that tolerance to the α1-AR blockade effect of carvedilol decreases with time, then it would     be unlikely that this pharmacologic property contributes to the efficacy of carvedilol. In     such a case other pharmacologic properties, such as antioxidant activity, would appear to be     important. These results will help guide future studies into CHF and AR blockade.   "
209036|NCT00585104|"     This study will test the hypothesis that mechanical efficiency as measured by pressure-volume     loop assessment should improve during short-term treatment with intravenous levosimendan.      Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which     has been shown to have beneficial hemodynamic effects in patients with decompensated     congestive heart failure (CHF). Levosimendan is a new calcium sensitizer that binds to     troponin C. This agent is approved in Europe for treatment of heart failure patients. In the     United States, this agent is currently under phase III investigation for intravenous     treatment of patients with acutely decompensated HF who have dyspnea at rest or with minimal     activity. Levosimendan has been studied in these patients with acute HF and is considered     experimental in the United States for this population.   "
209037|NCT00585117|"     Hypoxia is a key factor in malignant progression of a neoplasm. It is our aim to explore the     basis for quantitative in vivo tumor imaging by Cu-61     diacetyl-bis(N4-methylthiosemicarbazone)PET imaging as a surrogate of tissue hypoxia. We     hypothesize that the hypoxia levels are predictive of the tumor response to therapy. Patients     will have 2 CU-ATSM PET scans done and the goal is to show spatially stable tracer     distributions that correlate with tumor hypoxia. This study will serve as a pilot study for a     PO1 submission   "
209038|NCT00585143|"     Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the     Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly   "
209039|NCT00585156|"     The purpose of this study is to evaluate the effect of Celebrex on bone growth into porous     coated implants, following postoperative total knee arthroplasty administration of Celebrex     for pain relief.   "
209071|NCT00587119|"     The purpose of the study is to find out the effects Budesonide, 9 mg daily for one year, has     on patients with Primary Biliary Cirrhosis with features of autoimmune hepatitis.   "
209072|NCT00587132|"     The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive     screening tool for pancreatic cancer in a high-risk population.   "
209040|NCT00585169|"     The goal of the proposed study is to evaluate the efficacy and safety of the drug memantine     in individuals with pathological gambling (PG). Thirty subjects with DSM-IV PG will receive     10 weeks of open-label treatment with memantine. The hypothesis to be tested is that     memantine will be effective and well tolerated in patients with PG. We hypothesize that     memantine will reduce the severity of gambling symptoms and improve patients' overall     functioning. This study will provide needed data on the treatment of a disabling disorder     that currently lacks a clearly effective treatment.   "
209042|NCT00585195|"     PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor     cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor     tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma     kinase (called ALK) tyrosine kinase and ROS receptor tyrosine kinases. This research study is     the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.   "
209043|NCT00585208|"     The purpose of this research study is to evaluate the safety and efficacy of ramelteon     (Rozerem™) as an add-on treatment for sleep problems in patients with bipolar disorder. This     study will determine whether or not the addition of ramelteon to ongoing medication(s) for     bipolar disorder is useful in improving sleep.   "
209044|NCT00585221|"     Imatinib (IM) has dramatically improved survival of gastrointestinal stromal tumors (GIST).     However, most patients become resistant to IM in less than two years. This clinical trial     combines targeted therapy (IM) with immunotherapy (peginterferon α-2b). Hypothesis:     Apoptosis/necrosis of imatinib-sensitive GIST releases GIST-specific antigens in vivo while     Peginterferon α-2b fulfills the role of cytokine signal (danger signal), this combination can     induce effective innate and adaptive anti-GIST immunity, which can eradicate     imatinib-resistant clones and GIST stem cells via recognition of common antigens shared with     imatinib-sensitive GIST, leading to improved response rate and remission duration.   "
209045|NCT00585234|"     This project seeks to develop a standardized technique for simultaneous capturing bi-planar     images of patients against a standard background with a grid that can be used later for the     quantitative determination of global balance and thoracic symmetry.      We hypothesize that patients who are successfully managed with surgery will demonstrate an     improvement in global balance and thoracic symmetry that can be accurately measured. This     measurement station will be specifically developed to provide a standardized, reproducible     means to compare clinical assessments of surgical and non-surgical outcomes, and establish     normative data for comparison. This standardized tool can be established at multiple centers     for use in multicenter trials.   "
209046|NCT00585247|"     Port wine stains are red birthmarks that without treatment persist for a lifetime. They are     frequently found on the face and can be conspicuous and disfiguring, negatively impacting     social interactions for these patients. Treating Port wine stains is difficult. The standard     of care is to use laser treatment, but over 80% of patients fail to completely clear despite     multiple treatments. The growth of additional blood vessels (angiogenesis) following the     Laser treatment is likely an important factor in why these lesions persist despite therapy.   "
209047|NCT00585260|"     The overall hypotheses are: 1) an indirect airway challenge procedure using mannitol can     safely characterize asthma phenotypes, predict asthma control and exacerbations, predict     responses to interventions, and perform more specifically than a direct methacholine     challenge and; 2) PX27 pore function in whole blood correlates with measures of airway     hyperresponsiveness induced by methacholine and/or mannitol challenges   "
209048|NCT00585273|"     Over the last decade, second generation antipsychotics have been increasingly utilized. Since     their introduction, however, atypical antipsychotics have been increasingly associated with     significant metabolic complications including hyperlipidemia, insulin resistance/diabetes     mellitus, and obesity. These metabolic complications increase the risk for cardiovascular     disease in populations with an already elevated risk.      The initial goal of the proposed study is to identify early signs of endothelial dysfunction     and vascular disease in those treated with atypical antipsychotics. The identification of     early signs of vascular disease may further link metabolic complications with any     cardiovascular risk. Demonstration of changes in vascular function associated with atypical     antipsychotics represents an important identifiable intermediate of more long-term     cardiovascular risk.      The second goal of the proposed study is to identify genetic factors that may be associated     with the development of cardiovascular disease, which can later serve as a guide to predict     risk. Accurate prediction of risk may facilitate the future development of an empirical,     risk-based, individualized selection process for antipsychotic medications.      Aim 1: To quantify the role of antipsychotic-induced metabolic complications on the     development of vascular disease using measures of endothelial function.      Hypothesis 1: Atypical antipsychotics will lead to greater impairments in endothelial     function, evidenced by decreased flow-mediated dilation from baseline measures and compared     with changes over time in controls. Medication-induced metabolic complications will be     temporally associated with these impairments in endothelial function.      Aim 2: To investigate the role of candidate pharmacogenetic polymorphisms with cardiovascular     and metabolic complications of atypical antipsychotics.      Hypothesis 2: Profiles of polymorphisms at receptors targeted by atypical antipsychotics will     be associated with impaired cardiovascular function and metabolic complications.   "
209049|NCT00585286|"     The purpose of this research study is to evaluate the safety and effectiveness of a new     investigational laser device for treatment of acne scarring, for improvement in the     appearance of surface texture and topography (recessed or uneven surfaces).   "
209050|NCT00585299|"     To assess whether reversal of fatty liver by moderate weight loss (8% of body weight) will     lead to improvements in insulin sensitivity, which will be associated with changes in both     glucose status and lipid profiles, in obese children and adolescents with fatty liver who     have normal glucose or pre-diabetes.   "
209051|NCT00585312|"     To test whether celecoxib can be used to prevent colon polyp formation in children with     familial adenomatous polyposis (FAP).   "
209073|NCT00587145|"     This study is an open-label, single center, and a single arm phase II study to evaluate the     clinical response and safety of perioperative S-1 plus docetaxel. Perioperative chemotherapy     is composed of 3 cycles of preoperative S-1/docetaxel and 3 cycles of postoperative     S-1/docetaxel.Chemotherapy regimen:        -  S-1 80 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)        -  Docetaxel 35 mg/m2 mixed in d5w 250 ml iv over 60-min on days 1 and 8   "
209052|NCT00585325|"     Patients will be randomized prospectively to one of two groups. One group will receive 5     mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their VAC     sponge ½ hour prior to VAC dressing change. All patients will complete a pain assessment tool     prior to receiving the instilled lidocaine/placebo, immediately after the procedure and 1     hour after the procedure. Pain scores will then be compared between the lidocaine and placebo     groups.      Risks: Lidocaine toxicity is a potential risk, but 5 mg/kg of 1 % Lidocaine is below toxicity     thresholds in an adult.   "
209053|NCT00586885|"     Purpose of this study is to assess the therapeutic efficacy of L-alanine in improving     biological and histological findings by administrating 6-18g/day L-alanine for one year. We     will also assess the safety and toxicity profile of long-term administration of L-alanine.   "
209054|NCT00586898|"     Objective: To determine the response to rapid hormonal cycling in patients with non-castrate     prostate cancer.   "
209055|NCT00586911|"     To assess the safety and efficacy of betaine in patients with NASH on markers of disease     severity such as liver histology, liver biochemistries, and health related quality of life.   "
209056|NCT00586924|"     To administer the highest dose that can safely be given to a patient and establish the safest     dose based on the highest tolerated dose for clinical testing.   "
209057|NCT00586937|"     The purpose of this study is to find out about the quality of life of individuals who have     been diagnosed and treated for lung cancer (lung cancer survivors). By quality of life, we     mean how you are feeling about different aspects of your life, including your physical     health, your emotional health, and your ability to carry out daily activities. We are     interested in people's opinions about their quality of life, as well as the factors that     affect their quality of life. Learning about quality of life will help us to develop new     services for lung cancer survivors.   "
209058|NCT00586950|"     The aim of this multi-center study is to determine the applicability of BMIPP to diagnosing     cardiac disease and to predicting the outcome of patients on hemodialysis.   "
209059|NCT00586963|"     This study is being done to for two reasons:        -  To learn about the effects (good and bad) esomeprazole (an FDA approved drug for reflux          esophagitis) has on your esophagus when taken correctly.        -  To learn about the quality of life changes (good and bad) you may experience with this          medication.   "
209060|NCT00586976|"     Cardiac surgery is associated with pain in the post-operative period. We plan to conduct a     study of local anesthetic, ropivacaine, infusion into the sternal wound in adult patients     undergoing cardiac surgery to see if it will be safe and result in improved pain control and     reduced time to extubation, duration of ICU and hospital stay.   "
209061|NCT00586989|"     This study is being done to determine if a new endoscope will help doctors identify     pre-cancer or early cancer lesions in patients who have Barrett's esophagus. This new     endoscope allows the doctor to look at the lining of the esophagus in 3 different ways by     modifying light.   "
209062|NCT00587002|"     The broad objective is to advance our understanding of both in vivo anatomical and functional     changes that are present in the coronary arteries in women who have an acute coronary     syndrome. Specific focus will be placed on the age of the women as there may be distinct     differences in younger women (< 50 years) given the marked increase in mortality in this     population.   "
209063|NCT00587015|"     A dose-escalation study to estimate the maximum tolerated dose(MTD) of CAT-8015 that can be     safely administered to a patient.   "
209064|NCT00587028|"     Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or     larger without cathartic preparation.   "
209065|NCT00587041|"     The purpose of this study was to determine the effect of two probiotic preparations     (Agri-King Synbiotic and Oxadrop) on urinary oxalate excretion in patients with mild     hyperoxaluria. Probiotics are live microorganisms thought to be beneficial to the host     organism. Hyperoxaluria is a hereditary disorder that causes a special kind of stone to form     in the kidney and urine. Oxalates are naturally-occurring substances found in plants,     animals, and in humans. Excretion of oxalates in the urine is a risk factor for kidney stone     formation.      Our hypothesis was that the mild hyperoxaluria is due to over absorption of oxalate from food     and that probiotics will improve gastrointestinal barrier function to decrease oxalate     absorption across the gut (and hence its elimination in the urine).      In the study, participants were randomized to placebo, Agri-King Synbiotic, or Oxadrop, and     were treated for 6 weeks. Patients were maintained on a controlled diet to remove the     confounding variable of differing oxalate intake and availability from food.   "
209066|NCT00587054|"     This is a phase II, single-center study to evaluate the efficacy of a novel cytoreductive     regimen followed by CD34+E- selected T cell depleted allogeneic stem cell (or soybean     agglutinated and E-rosetted BM) transplant as treatment for patients with acute and chronic     leukemias, lymphoma and myelodysplstic syndrome/PNH. The impact of the change in conditioning     regimen and use of CD34-selected T cell depleted PBSCs on transplanted related morbidity and     mortality and disease free survival will be assessed.   "
209067|NCT00587067|"     This phase II study aims to evaluate regional chemotherapy in patients with unresectable     primary hepatic malignancy. Specifically, eligible patients with hepatocellular carcinoma and     peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary     Surgery service, will undergo hepatic artery pump placement and continuous infusion of FUDR.     The protocol includes radiological and biological correlative studies.   "
209068|NCT00587080|"     To evaluate the correlation between clinical and radiological outcome after Stapled TransAnal     Rectal Resection (STARR)   "
209069|NCT00587093|"     The purpose of the research is to determine if blood tests and a CT scan done before surgery     can predict how successful the surgery will be. In patients who have cancer of the ovary that     has spread, it is hoped that the CT scan will be able to identify the various places where     the cancer has spread so that additional surgeons can be available to help with the surgical     procedure.      If you have confirmed stage 3 or 4 ovarian, fallopian tube, or primary peritoneal cancer, you     may undergo a CT scan of the abdomen and pelvis after the surgery to compare how much cancer     the surgeon thought was left after surgery to what is seen on CT scan. A CT scan of the chest     will be done if your physician thinks it is necessary.   "
209070|NCT00587106|"     This study is for patients with cancer, a known paraneoplastic syndrome, or neurological     problems that suggest a paraneoplastic syndrome.   "
209074|NCT00587158|"     This study is being done to find out whether patients who receive a kidney transplant can     benefit from taking the medication paricalcitol (trade name Zemplar®) as compared to kidney     transplant recipients not taking this medication. The main possible benefits being studied     are:        -  Lower risk for overactive parathyroid glands after kidney transplantation.        -  Lower risk of low bone density in the spine and hip after kidney transplantation. By          dividing patients in the study into a group receiving Zemplar® and a group not receiving          Zemplar®, it will be possible to understand the good and bad effects of Zemplar® during          the first year after a kidney transplant.   "
209075|NCT00587171|"     This study is comparing the effectiveness of patching combined with active vision therapy     plus near activities versus patching combined with control vision therapy plus near     activities for moderate amblyopia (20/40-20/100) in 7 to <13 year olds.      The primary outcome measure is the proportion of patients with visual acuity of 20/25 or     better in the amblyopic eye at the 17-week masked exam. These patients will be considered     treatment responders. The primary analysis will consist of a comparison between the 2     treatment groups of the proportion of treatment responders with adjustment for baseline     visual acuity.      Secondary outcomes are stereoacuity at the 17-week masked exam, mean improvement in visual     acuity at the 17-week masked exam, and rate of improvement of visual acuity.   "
209077|NCT00587197|"     Patients with cirrhosis require endoscopic screening for large esophageal varices. The aims     of this study were to determine the cost -effectiveness and patient preferences of a strategy     employing abdominal computerized tomography (CT) as the initial screening test for     identifying large esophageal varices. In a prospective evaluation,102 patients underwent both     CT and endoscopic screening for gastroesophageal varices. Two radiologists read each CT     independently; standard upper gastrointestinal endoscopy was the reference standard.     Agreement between radiologists, and between endoscopists regarding size of varices was     determined using kappa statistic. Cost-effectiveness analysis was performed to determine the     optimal screening strategy for varices. Patient preference was assessed by questionnaire. CT     was found to have an approximately 90% sensitivity in the identification of esophageal     varices determined to be large on endoscopy, but only about 50% specificity. The sensitivity     of CT in detecting gastric varices was 87%. In addition, a significant additional number of     gastric varices, peri-esophageal varices, and extraluminal pathology were identified by CT     but not identified by endoscopy. Patients overwhelmingly preferred CT over endoscopy .     Agreement between radiologists was good regarding the size of varices (Kappa = 0.56), and     exceeded agreement between endoscopists (Kappa = 0.36). Use of CT as the initial screening     modality for the detection of varices was significantly more cost-effective compared to     endoscopy irrespective of the prevalence of large varices. In conclusion, abdominal CT as the     initial screening test for varices could be cost-effective. CT also permits evaluation of     extra-luminal pathology that impacts management.   "
209078|NCT00587210|"     The purpose of this study is to assess the exam quality and accuracy of MR using a new oral     contrast agent for the evaluation of Crohn Disease in the small bowel.   "
209079|NCT00587223|"     The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing     wounds in subjects with dystrophic or junctional epidermolysis bullosa. Apligraf will be     evaluated for efficacy and safety compared to a conventional nonadherent dressing. A     matched-pair design will be used to evaluate Apligraf treatment versus conventional treatment     in 68 study pairs.   "
209080|NCT00587236|"     This study is being done to:      To attempt to increase the detection of precancerous colon tissue in patients with chronic     ulcerative colitis and primary sclerosing cholangitis;      To determine if an investigational scope that can look at the lining of the colon in     different ways will help the doctor identify abnormal tissue in patients with chronic     ulcerative colitis and concurrent primary sclerosing cholangitis; and      To determine if this investigational scope can accurately detect precancerous or cancerous     tissue in patients with chronic ulcerative colitis that are known to have had cancerous or     precancerous tissue in the past.   "
209081|NCT00587249|"     The purposes of this study are to evaluate the safety and immune responses (the body's     defense system) to an investigational malaria vaccine called ICC-1132. Three different doses     of the vaccine will be studied in 3 groups of people, and the results will be compared. The     study will involve about 80 healthy volunteers, 18-45 years of age, who will receive an     injection of a specific dose of the vaccine in their arm on 2 or 3 different days. Blood     samples will be collected approximately 15 times for laboratory studies. Volunteers will     record their temperature twice per day. Volunteers will complete a daily symptom diary for 7     days after each vaccination. Volunteers will participate in the study for up to 13 months.   "
209082|NCT00587262|"     Insertion of electrode array in scala vestibuli, rather than the preferred location within     scala tympani, leads to loss of native hearing in those patients with isolated high-frequency     hearing loss undergoing cochlear implantation.   "
209083|NCT00587275|"     The purpose of this project is to test how safe and how well AST-120, an investigational     product, works in treating too much acid in the stomach. Patients will be randomly assigned     to one of two groups, AST-120 or a placebo for the first four weeks of the study. The     patients will be switched to the other group (AST-120 or placebo)for the following four     weeks.   "
209084|NCT00587288|"     The purpose of this study is to determine the effectiveness and safety of reslizumab in the     treatment of subjects with poorly controlled asthma.   "
209085|NCT00587301|"     This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in     the morbidly obese adolescent population.   "
209086|NCT00587314|"     To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation )     on Barrett's Esophagus   "
209087|NCT00587327|"     The main purpose of this clinical research trial was to evaluate the effects of barusiban and     atosiban compared to placebo on luteal phase uterine contractions in oocyte donors     supplemented with progesterone.   "
209114|NCT00587717|"     This study is being done to determine if the acute administration of the drug Simvastatin     reduces plaque tissue inflammation and plaque instability in patients undergoing carotid     endarectomy   "
209088|NCT00587340|"     The purpose of this study is to gain greater understanding of the problems breast cancer     survivors experience related to difficulty sleeping and insomnia. Poor sleep can affect a     person's mood, increase feelings of fatigue, as well as pain. A greater knowledge and     understanding of sleep disturbances can lead to more effective treatment of sleep problems     and significantly improve quality of life.   "
209089|NCT00587353|"     Tobacco prevention and intervention strategies in the general population are ongoing and     evolving. However, strategies to help cancer patients overcome tobacco dependence have been     limited. Radiation oncology patients who continue to smoke despite their cancer diagnosis     have a lower quality of life (QOL), increased frequency and severity of side effects during     their cancer treatment, higher risks of developing a smoking-related primary cancer, and may     have a poorer survival rate than their non-smoking counterparts. These are all compelling     reasons to be more pro-active in helping cancer patients stop smoking. The overall objective     of this project is to adapt a model of an effective tobacco use intervention that can be     delivered by any trained radiation oncologist and their staff.   "
209090|NCT00587379|"     To determine if 6 weeks of daily treatment with Atorvastatin 40 mg alters the immediate     effect of Sildenafil Citrate (Viagra, Pfizer Inc, New York, NY) on endothelial function     (activity of the artery) as measured by noninvasive peripheral arterial tonography in men and     women. Also, to determine if 6 weeks of daily treatment with Atorvastatin 40 mg affects     erectile function in men   "
221191|NCT00740441|"     The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal     Cell Carcinoma   "
209091|NCT00587392|"     The purpose of this study was to gather long-term follow-up data on patients treated with the     Plicator in a previous open-label multi-center study. Originally, 64 subjects were treated at     seven U.S. sites. A subset of those patients were subsequently reassessed via symptom     questionnaires in this long-term (60-month) follow-up analysis. The initial open-label study     was completed and officially closed at the completion of 1-year follow-up. This current study     was designed to collect long-term follow-up data on previously plicated subjects all of whom     were recruited de novo from the original study population. Study endpoints were prospectively     defined. The primary study objectives were to assess: reduction in GERD symptoms through     analysis of the GERD Health Related Quality of Life (HRQL) questionnaire and the     Gastrointestinal Symptom Rating Scale (GSRS); reduction in use of GERD medications, and     change in overall physical and psychological health as measured by the Short Form Health     Survey (SF-36).   "
209092|NCT00587405|"     To see if either method of treatment for Watermelon Stomach shows better results   "
209093|NCT00587418|"     Chronic renal insufficiency is a common and important health problem that causes morbidity     and mortality among patients who have undergone liver transplantation. It is mainly caused by     drugs (calcineurin inhibitors) that are used to prevent or treat rejection and once     established, there is no effective treatment. This research investigates whether L-arginine     can reverse the effects of calcineurin inhibitors on the kidneys and thus prevent renal     insufficiency in liver transplant recipients.   "
209094|NCT00587431|"     We postulate that multiple apoptototic events are indusce through testosterone depletion and     repletion with taxotere given in conjunction with androgen withdrawal.   "
209095|NCT00587444|"     Study has been completed and is in the data analysis and manuscript writing phase of the     project.   "
209096|NCT00587457|"     This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety     and anti-neoplastic activity of moxetumomab pasudotox in relapsed or refractory participants     with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or Small Lymphocytic     Lymphoma (SLL).   "
209097|NCT00587470|"     Mitral regurgitation (MR) is common in the elderly and its prevalence is increasing with the     aging of the population. Organic MR, due to primary valvular lesions, initiates a cascade of     complications determined by its degree. MR of severe degree is associated with excess     mortality and high cardiac morbidity (heart failure, atrial fibrillation). It also causes     left ventricular remodeling which induces left ventricular dysfunction, which in turn leads     to poor clinical outcome. Surgery can eliminate MR, but carries immediate and long-term     risks, especially in the elderly. Therefore, chronically decreasing the degree of MR is a     major goal of medical therapy but such an effect is yet unproved because of conflicting     results of small and mostly non-randomized series. Our recent preliminary studies suggest     that a sustained decrease of degree of MR and improvement of left ventricular remodeling can     be achieved with powerful reduction of afterload, obtained in particular with angiotensin-II     receptor blockade. Therefore, the present proposal seeks to address gaps of knowledge     regarding vasoactive treatment of MR through the verification of the following hypothesis:     Hypothesis: Vasoactive therapy using angiotensin-II receptor blocker (Candesartan Cilexetil)     weighed against placebo produces a sustained reduction of the consequences of organic MR. The     specific aims are that the treatment a) decreases the degree of MR (decreases the regurgitant     volume, primary end-point) and b) improves left ventricular remodeling (decreases the     end-diastolic volume index, secondary end-point), as compared to placebo.   "
209098|NCT00587483|"     This was a prospective, randomized, double blinded study in which patients undergoing a     cardiopulmonary bypass (CPB) with aortic cross clamping were randomly assigned to receive     amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. (CPB is     a technique that temporarily takes over the function of the heart and lungs during surgery,     maintaining the circulation of blood and the oxygen content of the body.) Specifically, we     will test the hypothesis that amiodarone is superior to both lidocaine and placebo in the     prevention of a severely abnormal heart rhythm when the blood flow is restored to the heart     after the aortic cross clamp is removed.   "
209099|NCT00587496|"     The purpose of this study is to determine whether oral Valtrex alone or in combination with     aspirin will reduce the shedding of herpes simplex virus DNA in the tears and saliva from     volunteers with no evidence of ocular herpes infection. The secretion of virus into the tears     and saliva might make people more susceptible to virus infection in the future if their     immune system becomes deficient. The study will also try to determine if there is a     correlation between shedding of viral DNA and herpes virus antibodies in serum and to     determine if subjects are carriers of a special form of a gene in their blood cells, the     presence of which may suggest the possibility of an increased susceptability to herpes and to     Alzheimer's disease and heart disease.   "
211942|NCT00624637|"     This study aims to determine the effect of massage with or without aromatherapy on infant´s     level of distress   "
209100|NCT00587522|"     The purpose of this prospective, multicenter study was to evaluate the safety and efficacy of     endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux.      Sixty-four patients were enrolled and underwent endoscopic full-thickness plication. All     patients received a single implant/plication. No repeat plication procedures were performed.      Primary efficacy in this study was measured by the percent reduction in post-procedure GERD     symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life)     questionnaire. Secondary efficacy outcomes included post-procedure reduction in     anti-secretory therapy, improvement in quality of life questionnaires, reduction in distal     esophageal acid exposure, and improvement in esophageal manometry. Patient follow-up     assessments were completed at 1, 3, 6 and 12 months post treatment.   "
209101|NCT00587535|"     The purpose of this study is to determine if a new MR pulse sequence is accurate in     determining how much iron is in the liver.   "
209130|NCT00587951|"     The aim of this study is to determine the role of SISCOM (see below) in aiding clinicians to     manage epilepsy surgery candidates. SISCOM is already a routine component of pre-surgical     epilepsy evaluation at Mayo Clinic. In particular, we are interested in assessing whether use     of SISCOM can minimize the need for prolonged (>24 hours) invasive monitoring with electrodes     placed on the surface of the brain prior to surgical resection.      Note: this study has recruited the required number of patients and is closed to further     enrolment.   "
209102|NCT00587548|"     This study is being done to find a different way to identify the ureters during an abdominal     operation.      During some operations, the operating physician must identify where the ureters are to     prevent injury to them. Typically, the surgeon calls the urologist to thread a small scope     with a camera into the urethra (where the urine comes out) to place a wire into each of the     two ureters to locate them. Instead of this procedure, we will inject a small amount of a     radioactive chemical dye (TC99-DTPA)through a vein in your arm. The ureters can then be     detected by a hand held probe called the 'gamma probe.' The TC99-DTPA dye passes through the     body and is excreted through the urine. The goal of this study is that this probe will alert     the physician when it placed directly over the ureters since the TC99-DTPA dye will highlight     the ureters as the flow of urine goes through them.   "
209103|NCT00587561|"     The term social cognition refers to how social information is processed. Individuals with     schizophrenia and schizoaffective disorder have been shown to have significant deficits in     social cognition. Moreover, it has been speculated that these deficits may in turn have a     negative impact on their overall functioning. Behavioral interventions targeting social     cognition are just beginning to emerge, and there is a need to evaluate their efficacy.      Objectives:      This is a small trial evaluating the efficacy of social cognition interaction training (SCIT)     an experimental behavioral treatment for improving social cognition in schizophrenia.      Research Design and Methodology:      Approximately 48 participants with schizophrenia-spectrum disorders will be randomized into     one of two conditions: 1) a 20 to 24 session manualized social cognition interaction training     group (SCIT), or 2) wait-list control. Pre-and post-group therapy assessments of symptoms,     social cognition, basic cognition, and community function will be conducted. Data obtained     from this study will allow us to determine the efficacy of SCIT training in improving     symptom, cognitive, and functional measures.   "
209104|NCT00587574|"     Allogeneic hematopoietic cell transplantation offers high cure rates for patients with     hematological and oncological diseases. Graft-versus-host disease (attack of donor's white     blood cells on patient's tissues) is a serious complication also affecting the patient's     immune system. Therefore, patients in the early phase after allogeneic cell transplantation     are at high risk for severe infectious complications. So far, no predictive biomarkers for     the development of the chronic form of graft-versus-host disease are available. By analysing     serially immune cell populations of the peripheral blood we will investigate whether certain     subsets of cells are associated with development of chronic graft-versus-host disease. In     addition, the patients' immune regeneration will be evaluated by serial analyses of     peripheral blood immune cell populations 3 months to 2 years after allogeneic cell     transplantation.   "
209105|NCT00587587|"     This pilot study will assess the safety and efficacy of Apligraf in the healing and     recurrence of keloids post surgical shave excision in patients with clinically diagnosed     keloids.   "
209106|NCT00587600|"     This study is being done to find out if Photodynamic Therapy (treatment with a red light and     a drug called photofrin) or Radiofrequency ablation works the same for patients who have     biomarkers (abnormalities in molecules of cells that may or may not help predict cancer)     present in their Barrett's esophagus as for patients who do not have biomarkers.   "
209107|NCT00587626|"     The purpose of the proposed study is to evaluate the efficacy of the InterX 5000 in relieving     chronic neck and shoulder pain. This study will focus on the efficacy of treating patients     who have functional limitations in activity because of chronic/recurrent neck or shoulder     pain.      H1: InterX therapy will have a moderate effect to reduce pain.      H2: Functional gains will be greater in patients receiving InterX therapy compared to those     who received placebo treatment.      H3: Chronic neck and shoulder pain is more prevalent in patients who exhibit radiographic     evidence of degenerative spondylosis/arthrosis of the cervical spine.   "
209108|NCT00587639|"     The objective of this investigation is to examine the safety and feasibility of a series of     repetitive transcranial magnetic stimulation (rTMS) treatments (10 Hertz [Hz]; Left     Dorsolateral Prefrontal Cortex), with a Neuronetics Model 2100 Therapy System as adjuvant     treatment for depression in adolescent subjects.   "
209109|NCT00587652|"     This study is being done to:      Determine if a temporary dye applied to the esophagus identifies areas of dysplasia     (pre-cancer). Determine if certain dye patterns indicate specific grades of dysplasia.     Determine if overall endoscopy costs can be reduced with this dye technique. Determine if the     dye could allow fewer biopsies to be obtained in the future.   "
209110|NCT00587665|"     Comparing patients receiving subanesthetic doses of Ketamine vs placebo to see if it can     reduce narcotic needs for patients receiving a tonsillectomy and adenoidectomy   "
209111|NCT00587678|"     The purpose of this study is to develop new ways of imaging fatty blockages in the leg     arteries to improve upon techniques used now and to develop new ways of understanding how new     treatments may affect the disease.   "
209112|NCT00587691|"     The purpose of the study is 1) to study the safety and tolerability of escalating doses of     myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of     T Cell Vaccine ion the clinical course of MS.   "
209113|NCT00587704|"     Primary aim:      1. To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1     in providing surgical anesthesia for patients undergoing inguinal hernia repair.      Secondary aims:        1. Compare VAS pain scores in the two groups of patients over the first 24 hours.        2. Compare opioid intake over the first 24 hours in the two groups of patients.   "
209128|NCT00587925|"     Bone Mineral Density (BMD) as measured by X-ray shows the amount of calcium in the bone. Low     BMD may reflect osteoporosis, a condition where there is an increased risk of fracture. Women     who have gone through menopause have a higher risk of getting osteoporosis because they lose     calcium from their bones much faster than younger women. Women with breast cancer may have an     additional risk for getting osteoporosis because of the effects of their treatment with     chemotherapy. The purpose of this study is to see what levels of BMD post-menopausal women     with breast cancer have, and to see if the level of BMD changes during a women's treatment     after her surgery. This trial studies changes in BMD and markers of bone activity in women     receiving treatment for early stage breast cancer.   "
209604|NCT00586235|"     Acquire CT data and US and transducer position data (magnetic sensor system) of focal hepatic     or renal lesions to serve as sample data sets for fusion algorithm development and subsequent     optimization.   "
209115|NCT00587730|"     The accuracy of stress single photon emission computed tomography (SPECT) is limited by     imaging artifacts, many of which are caused by soft tissue attenuation. A recent multicenter     study performed by our laboratory comparing 7 commercially available attenuation correction     (AC) camera systems in a cardiac phantom showed the best performance with the GE Hawkeye (a     hybrid gamma camera-CT scanner) and the University of Michigan M-step (unique feature a     camera orbit of 360˚ versus the usual 180˚) systems. In this study we will combine the     strengths of these two systems (GE Hawkeye AC system and 360˚ camera orbit) to test the     accuracy of this imaging system in a population of 400 consecutive patients undergoing     clinically indicated stress SPECT. These patients will undergo SPECT imaging both with     conventional methodology and the GE Hawkeye system. The conventional study will be     interpreted and reported in the usual clinical fashion. The GE Hawkeye images will be     interpreted independently by 2 observers blinded to the results of conventional imaging and     will not be reported clinically. The primary study hypothesis is that AC will substantially     reduce attenuation artifacts (mild fixed defects) without reducing the accuracy of either     normal studies or myocardial infarction (MI). Clinical data and noninvasive test results     (history of MI, electrocardiogram, and gated wall motion) will be used to distinguish defects     which represent attenuation (false-positive) versus those due to MI (true-positive).   "
209116|NCT00587756|"     Two-stage hepatectomy with or without portal vein embolization allows to treat multiple     bilobar metastases expanding surgical indications for these patients. However, it has some     related drawbacks: two operations are needed, and some patients do not complete the treatment     strategy for disease progression. Using experience gained from our ultrasound guided     resection policy we explored the safety and effectiveness of one-stage surgical procedures in     patients otherwise recommended for the two-stage approach.   "
209117|NCT00587769|"     The overarching goal of this line of research is to increase smoking abstinence rates using a     combination of existing pharmacotherapies. The aim of the current study is to assess the     safety and compliance as well as obtain preliminary estimates of efficacy and effect on     craving and nicotine withdrawal of combination therapy with bupropion SR and varenicline. We     will compare the efficacy estimates in this study with historical smoking abstinence rates     with varenicline. To accomplish our aims, we will enroll 38 cigarette smokers in an     open-label, phase II clinical trial.   "
209118|NCT00587795|"     Objectives:      - To obtain clinical evidence for the safety and efficacy in using the StabilAir Wrist     Fracture Brace for the following cases:        1. Acute (emergency department) treatment of non-displaced, stable extra- articular distal          radius fractures;        2. To obtain comparative data between traditional therapies (sugar tong, plaster backslab,          long arm or short arm cast) and the use of the StabilAir brace for each patient          qualified by specific criteria.      Hypothesis:      1) For stable, non-displaced fractures, the StabilAir Brace is as effective as a sugar tong     splint in the acute setting. 2) In cases where full forearm immobilization is initially     preferred, the StabilAir is effective as a follow-up to sugar tong splitting once the need     for full immobilization has passed.   "
209119|NCT00587808|"     The guiding hypotheses are that (1) mechanisms in addition to diastolic dysfunction, while     normal at rest, are compromised with stress, leading to symptoms of HF, and (2) that an     increased proportion of the increase in LV diastolic pressures seen in HFpEF is mediated via     exaggerated pericardial/right heart-LV coupling (restraint).   "
209120|NCT00587821|"     This study is being done to learn about blood proteins. We want to see if the blood proteins     in women whose biopsies show breast cancer are different from the blood proteins in women     whose biopsies do not show breast cancer. The goal of this study is to develop a blood test     than can help detect breast cancers when they are very small and easy to cure.   "
209121|NCT00587834|"     The purpose of this study is to evaluate Gintuit as a safe and effective alternative to     palatal tissue in the treatment of subjects (with recession-type defects) who have an     insufficient zone of attached gingiva associated with at least two nonadjacent teeth.   "
209122|NCT00587847|"     This is a study designed to test whether giving campath (also known as alemtuzumab) on a     maintenance schedule will prolong the time until the patient requires chemotherapy.   "
209123|NCT00587860|"     This study is being done to see if St. John's wort helps people with irritable bowel     syndrome, otherwise known as IBS. St. John's wort is a herbal supplement derived from the     St. John's wort plant. It has been shown to be helpful in several medical conditions such as     depression as well as other pain syndromes.   "
209124|NCT00587873|"     The objective of this study is to determine the incidence of complete and partial response     and the duration of response in patients with recurrent or resistant Hodgkin's disease (HD)     treated with sequential administration of oral 6-Thioguanin (6-TG) after IV Methotrexate     (MTX).   "
209125|NCT00587886|"     The purpose of this study is to see how people's diets, other aspects of their lifestyles,     and their individual genetic makeup affect their chances of getting endometrial cancer     (cancer of the uterus).      This survey will enroll several hundred women who have or have had endometrial cancer and     several hundred who do not. We will compare these two groups of women to see what factors may     lead to endometrial cancer.   "
209126|NCT00587899|"     This study is being done to learn the effects of the Pulmonary Vein Isolation in patients     that are at high risk to developing, but do not have a documented history of atrial     fibrillation.   "
209127|NCT00587912|"     The purpose of this study is to obtain clinical specimens from pathologists and physicians     involved in the diagnosis and care of patients with AIDS and non-AIDS associated     malignancies.      The National Cancer Institute has set up a Bank for tissues and biological fluids from     HIVpositive and HIV-negative individuals in order to have specimens available for scientists     studying malignancies associated with HIV disease.   "
209138|NCT00588068|"     The purpose of this study is to find out the genetic and biochemical makeup of your     neuroblastic tumor, which influences its aggressiveness and the suitable therapy. These     research studies include surface marker analysis, cytogenetics, cancer genes,genome     sequencing, tumor growth-related genes and tumor growth in test tubes. Your blood, marrow,     and hematopoietic stem cell samples will also be tested for tumors or leukemia cells, and     your serum tested for anti-tumor antibodies.   "
221492|NCT00743886|"     To evaluate the influence of Plasma Rich in Growth Factors (PRGF) on the healing process of     medial collateral ligament (MCL) tear.   "
209131|NCT00587964|"     For patients who have one or two metastases in the brain, the tumor(s) can often be removed     with surgery to relieve symptoms from the tumor(s) and to improve survival. However, about     half of all patients who have the tumor(s) removed with surgery will develop regrowth     (recurrence) of the tumor. To prevent this regrowth of tumor, some patients receive radiation     to the entire brain (whole brain radiation) after surgery. This involves daily treatment for     about two to three weeks, and may cause long-term neurological problems, such as memory loss.      Stereotactic radiosurgery (SRS) is sometimes used instead of surgery to treat brain     metastasis. This involves the use of a special head frame and sophisticated computer programs     that enable us to deliver a high dose of radiation to a small focused area of the brain in     only one treatment.      Research has shown that the results of treatment with SRS are as good as surgical removal of     the tumor. SRS and surgical resection are considered the standard options for the treatment     of brain metastases. This Phase II clinical trial is studying the combination of these two     techniques. The purpose of this study is to evaluate the use of SRS following surgical     removal of brain metastases. The outcomes we will be looking at are tumor regrowth after     treatment and side effects of treatment.   "
209132|NCT00587977|"     Can software be developed to automatically aid in the measurement of abdominal aortic     aneurysms, and is there a way to predict future rupture or growth of abdominal aortic     aneurysms.   "
209133|NCT00587990|"     Heart attacks are a leading cause of death in both men and women in the United States. When a     person has a heart attack, blood is unable to reach a certain area of the heart, and if the     blood supply is not re-established quickly, that area of the heart can suffer permanent     damage. While recovery from a heart attack can be managed through medications and lifestyle     changes, these treatments can not reverse the original damage to the heart. Current research     is focusing on the development of cell-based therapies using stem cells to repair organs that     have been irreversibly damaged by disease. A specific form of stem cells, called adult     mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate     the safety and effectiveness of injecting MSCs into the heart to repair and restore heart     function in people who have had a heart attack and who are having heart surgery for coronary     artery bypass grafting (CABG).   "
209134|NCT00588003|"     The purpose of this pilot study is to see if taking anastrozole (Arimidex) for 10 days causes     changes in breast cancer cells. Anastrozole (Arimidex) is a drug used in the treatment of a     type of breast cancer that depends on estrogen to grow. This type of breast cancer is called     estrogen receptor positive breast cancer. Anastrozole (Arimidex) works by blocking an enzyme     in your body called aromatase. Aromatase is found in your muscles, fat, liver and in breast     tumors. This enzyme is important for making estrogen in women who are no longer having     menstrual periods. Anastrozole decreases levels of estrogen in the body. We are interested in     seeing if taking anastrozole for 10 days will cause changes in breast cancer cells. We will     study cell processes such as how they make new blood vessels, how quickly the cells multiply,     and how soon they die. We will also study which genes in the breast cancer tissues are turned     on or off by taking anastrozole for 10 days.   "
209135|NCT00588016|"     The primary objective of this study is to determine the concentration of itraconazole     irrigation in nasal mucous specimens via collection and High-performance liquid     chromatography (HPLC) assay.      Eight (8) patients with chronic rhinosinusitis (CRS) and two (2) healthy controls will be     enrolled in the initial evaluation. After an initial control nasal specimen, followed by     seven days of twice daily topical itraconazole irrigation, nasal specimens will be collected     at varying time intervals and the concentrations measured.      The primary endpoint is development of a reliable collection and assay technique with     concentration curves over time of topically administered itraconazole. A secondary endpoint     is to determine if the concentrations measured achieve a mean inhibitory concentration     (MIC90) to commonly cultured fungal species in the nose.   "
209136|NCT00588029|"     The purpose of this study is to collect a blood sample from patients with breast disease     (cases) and from individuals without breast cancer (controls)that may be used for research     purposes. These blood samples will be used by researchers at Memorial Sloan-Kettering Cancer     Center who study the causes of breast cancer, as well as more effective ways to prevent,     diagnose, and treat breast cancer.   "
209137|NCT00588042|"     Ischemic preconditioning (IP) has been shown in animal studies to increase the myocardial     tolerance to subsequent ischemia. Our primary hypothesis is that remote IP reduces myocardial     ischemic injury during PCI.   "
209139|NCT00588081|"     This study is being done to find out more about the experience women have with vaginal     reconstruction. We hope to learn about their quality of life, sexual function, and body     image. We would like to find out how happy women are with surgery. We also want to know what     things should be changed or improved. Since you have had this surgery, we would like to ask     you to take part in an interview.   "
209140|NCT00588094|"     The purpose of this research is to study a treatment program for patients with aggressive     lymphoma that has come back after initial or first therapy (called relapsed) or that has not     responded to first therapy (called refractory). Since 1993, we have used a combination of     chemotherapy known as ICE (Ifosfamide, Carboplatin, and Etoposide) for your type of lymphoma.     In many patients, this treatment helps the disease to shrink before giving high-dose therapy     and autologous stem cell transplant (ASCT). Only patients who respond to these types of     treatments have a chance of their disease going away (remission) with an ASCT. In 1999, we     studied the same treatment but added another medicine for your type of lymphoma, Rituximab     (Rituxan), to the ICE treatment (RICE). More patients had lymphoma shrinkage from this     treatment (chemosensitive disease) than with ICE alone. These patients then received high     dose therapy and autologous stem cell transplant and have an improved chance of having a     remission.      ICE chemotherapy is standard chemotherapy used at Memorial Sloan-Kettering Cancer Center.     However, it is different in this study because of the higher doses. We are testing higher     doses of RICE treatment for patients in this study.      In our current study in Hodgkin's lymphoma, we are giving these higher doses of ICE (called     augmented ICE) to patients who also have higher risk. We hope to show in this study that by     using Rituximab and augmented ICE that we can improve your ability to achieve a remission     (that is, to have the disease go away).   "
209605|NCT00586248|"     In this prospective pilot study, we proposed to evaluate the effects of left interscalene     stimulation on cardiac pacemaker function.   "
209141|NCT00588107|"     The purpose of this study was to compare two different ways of helping people who have had     childhood cancer, leukemia, tumors or similar illnesses learn health information and     information about trying to quit smoking. All participants received materials in the mail     about their health, survivorship, and smoking. Some participants were also invited to use a     website. The goal of the study was to see which is a better way to get information about     health issues, survivorship, and smoking.   "
209142|NCT00588120|"     The purpose of this study is to learn more about a condition called 'unclassified     hyperoxaluria'. People with this condition have large amounts of oxalate in their urine,     which can cause kidney stones and kidney failure. We do not know what causes the high level     of oxalate in the urine. In this study, we will evaluate absorption of a test dose of oxalate     taken orally by measuring the amount of the test dose that is eliminated in the urine. We     will compare the results of affected patients to healthy volunteers.   "
209143|NCT00588133|"     Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac     surgery and cardiopulmonary bypass. We have developed an assay for tranexamic acid. We have     developed an alternative dosing schedule for tranexamic acid. The objective of this     preliminary study is to determine if this new dosing schedule can achieve the desired plasma     concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic     acid plasma concentrations relative to the current dosing schedule.   "
209144|NCT00588146|"     The purpose of the study is to evaluate the safety and tolerability of pegylated interferon     alpha-2b (PEG-Intron) in patients with severe complications related to Hereditary hemorrhagic     telangiectasia (HHT).      Funding Source - FDA Office of Orphan Products Development (OOPD)   "
209145|NCT00588159|"     One dose of either gabapentin or placebo will be given to patients prior to thoracotomy.     Patients will also receive an epidural infusion, intravenous patient-controlled analgesia     with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal     analgesia. Pain ratings and supplemental medication use will be recorded for 48 hours and     will also be assessed at 3 months postoperatively to determine whether the patients who     received gabapentin had improved analgesia and/or required less supplemental medication than     the placebo group.   "
209146|NCT00588172|"     Type 2 diabetes its microvascular and macrovascular complications have become a major global     health problem. Metformin is often used as first-line therapy for this disorder given that it     is cheap, may cause weight loss and does not have significant side-effects in healthy     patients. On the other hand, as many as one third of all patients with type 2 diabetes     initially treated with metformin never achieve a meaningful response to this intervention.     Recently, genetic variation in the organic cation transporter 1 (Oct1) gene which encodes a     protein, OCT1, mediating metformin uptake by the liver, its primary site of action, has been     shown alter metformin action. In Oct1-deficient mice the glucose-lowering effects of     metformin are completely abolished. Moreover a polymorphism with a 20% minor allele frequency     in Caucasians also alters the effect of metformin on glucose tolerance (the net result of     glucose uptake and glucose release) after ingestion of 75g of glucose. However, it is unknown     if this polymorphism affects suppression of endogenous glucose production or stimulation of     peripheral glucose uptake by metformin, or both, and to what degree. We propose to utilize     established methodology to measure glucose turnover in response to a mixed meal to determine     how common genetic variation in OCT1 alters response to metformin in healthy volunteers. This     will clarify the effect of these variants on response to metformin in humans. The knowledge     gained from this study will help to design future studies examining the role of OCT1 genotype     in determining initial therapy for type 2 diabetes.   "
209147|NCT00588185|"     This study will use PET scans, which is a type of x-ray test that uses a radiotracer, to see     whether these scans may be better able to find places in the body where your prostate cancer     may have spread.   "
209148|NCT00588198|"     The purpose of this study is to determine if tumor cells can be detected in the peripheral     blood and/or bone marrow of patients with melanoma.   "
209149|NCT00588211|"     The purpose of this study is to develop an accurate way of measuring people's thoughts about     cancer risk. The researchers at the Queens Hospital Center, Memorial Sloan-Kettering Cancer     Center and Adelphi University are working together to design a new measure. Findings from     this study will help us find new ways to help people avoid cancer.   "
209150|NCT00588224|"     The goal is to study the accuracy of 3-dimensional ultrasound (which does not involve     radiation) to measure the size of the stomach, comparing it with a previously validated     method that involves radiation. This will make it possible to check the stomach function of     children without exposing them to radiation. A second goal is to measure the size of the     stomach and the effect of a standard meal on stomach volume in adolescent boys and girls.   "
209169|NCT00588471|"     The goal of this study is to determine if one dose of simvastatin will decrease the     inflammatory response to coronary intervention. Also to determine if one dose of simvastatin     affects endothelial function (activity of the artery) as measured by noninvasive peripheral     artery tonography.   "
209159|NCT00588341|"     In this study, we want to find out how likely it is for temozolomide to shrink melanoma     tumors that have spread only to areas that could be removed by surgery. We also want to study     the melanoma before and after temozolomide treatment to learn why some tumors respond and     others do not. This is a Phase II trial. This means that it will test a drug - in this case,     temozolomide -- that has already been studied and shown to be safe.      Surgery, when possible, is the main treatment for patients with melanoma like yours. In most     people, however, melanoma cells have already spread to other places in the body. This means     that even with surgery, many people will have the melanoma come back. This is often fatal.      One goal of this trial is to treat the melanoma cells that might have spread before they have     a chance to grow.      As part of this trial, we also study which genes are turned on and which genes are turned off     in your tumor. We will obtain tumor from the biopsy done before you started temozolomide     treatment and from the tumor removed during the surgery done after you finish temozolomide     treatment. This may help us understand how temozolomide works and how to recognize which     tumors will respond.      Before and during the temozolomide treatment, we will also test a new way of measuring the     amount of tumor present. This involves a special way of analyzing the CT scan which you will     have anyway. This new technique may allow us to see tumor shrinkage very early in the     treatment course.   "
209151|NCT00588237|"     The purpose of this study is to test whether it is safe to treat your cancer with 3 drugs     instead of 2 drugs. After surgery, your cancer is typically treated with 2 drugs called     cisplatin and paclitaxel (also known as Taxol). Cisplatin is given through a port in your     belly, and Taxol is given both through the belly port and through the vein (IV). Large     clinical studies have shown that this treatment gives the best results for women with your     cancer. This treatment, however, also causes many side effects, especially belly pain, nerve     injury, lowering of the immune system, and infection risk. In the study you are being asked     to join, the dose of Cisplatin will be lower in order to try to lessen these problems. This     study will also test the safety of adding a 3rd drug called bevacizumab (also known as     Avastin). This drug has been shown to shrink ovarian, peritoneal, or fallopian tube cancer in     some patients who have advanced disease, despite having received prior treatment for their     cancer. Therefore, it may also be effective in patients, like you, who have a new diagnosis.      Unfortunately, Avastin can cause some dangerous side effects in women with advanced cancer.     For instance, it can cause a hole in the intestines, and can increase the risk of blood clots     and strokes. Avastin has not been given at the same time as IP therapy, so it is not known if     this is a safe or effective combination. In this study, IV Avastin will be given in addition     to IP cisplatin, IP Taxol, and IV Taxol, to patients like you who have not had any     chemotherapy before. This study aims to find out what effects, good and/or bad, that this     combination of drugs has on your body and on your type of cancer.   "
209152|NCT00588250|"     Hypothesis: a special solution for improving human embryo implantation, when added to the     solution during embryo transfer, will improve implantation rates in embryo transfers using     previously frozen embryos.   "
209153|NCT00588263|"     The intent of the proposed study is to describe the prevalence of the most common recurring     mutations in BRCA1 and BRCA2, blmAsh , and the A636P MSH2 mutation among Ashkenazi Jewish     individuals with a variety of cancer diagnoses. If a substantial proportion of these samples     contain such mutations, future patients presenting with these diseases may wish to undergo     genetic counseling and, if appropriate, formal genetic testing. The benefit from such a     process would pertain mainly to the families of these individuals.   "
209154|NCT00588276|"     The purpose of this study is to evaluate low oxygen areas called hypoxia within the tumor.     These low oxygen areas are thought to be the reason why tumors are more resistant to     radiation treatment. A tracer is an extremely small quantity of a substance. Tracer to which     radioactivity has been attached may be used to trace events in the body. A tracer called     iodo-azomycin galactopyranoside (or *IAZGP) appears to be able to detect low oxygen areas     within tumor.      Radioactive iodine in this molecule can be detected by an imaging technique called a PET     scan. This present study involves obtaining three scans using this new imaging technique. The     goal of carrying out many scans is to determine which scan will best show any areas in your     tumor that may have low levels of oxygen.   "
209155|NCT00588289|"     This protocol is not an independent research study, but rather a means to aggregate     Children's Cancer Group protocols that are closed to patient entry for the purpose of     collecting current status information on those patients treated under those protocols.   "
209156|NCT00588302|"     The blockade of angiotensin II synthesis attenuates hepatic fibrosis in different     experimental models of chronic liver injury. We aimed to determine the safety and efficacy of     moexipril, an angiotensin-converting enzyme (ACE) inhibitor, on liver biochemistries, Mayo     risk score, and health-related quality of life in patients with primary biliary cirrhosis     (PBC) who have had a suboptimal response to ursodeoxycholic acid (UDCA).   "
209157|NCT00588315|"     This study investigates new non-invasive imaging techniques for the evaluation of skin     lesions, as well as normal skin. Our primary goal is to collect and study these images of     different skin lesions along with matching biopsy specimens. The long-term goal is to develop     a technique that will improve the early detection of skin cancer and eliminate the need for     many skin biopsies.      The integrated handheld CSLM-OCT device will provide the first truly co-registered images of     en face optical section planes (confocal) with orthogonal optical section planes (OCT).      The imaging with a polarization-sensitive hyper-spectral dermoscope (SkinSpect) will add to     the interpretation of CLSM images. SkinSpect will produce tissue-level functional data (i.     e., skin chromophore maps of melanin and hemoglobin) in larger fields of view, which will be     combined with the cellular-level detail from CLSM imaging. The combined approach will be     tested for more accurate detection of skin morphologic characteristics.   "
209158|NCT00588328|"     The purpose of this study is to find out whether a new device can help obtain more accurate     CT and PET scans of the lungs and chest tumors and the liver and liver tumors to help in     delivering radiation therapy. When we breathe, the amount of air in the lung changes. Lung     tumors may also move during breathing. Liver tumors may also move with breathing; as the     lungs inflate, the liver can be pushed down. A CT scan (a special type of X-ray) is routinely     obtained as part of planning for lung or liver radiation therapy. Since patients breathe     during this CT scan and their lung or liver tumors move, these CT scans can sometimes be     inaccurate. We are now testing a device to only obtain the CT and an additional PET scan     while patients are breathing in or out. This will hopefully allow us to deliver radiation     with more accuracy.   "
209170|NCT00588484|"     Develop a standard technique and demonstrate adequate precision for measurement of     intima-media thickness (IMT) for routine clinical use.   "
209181|NCT00588640|"     The purpose of this study is to determine the safest dose of d-methadone that can be given,     without causing severe side effects in most patients with chronic pain. Patients are being     asked to participate in the Phase I portion of this study.   "
209182|NCT00588653|"     Prospective study to compare in a blinded fashion four different diagnostic modalities to     detect active small bowel Crohn's disease: a) colonoscopy with ileoscopy; b) small bowel     follow through; c) capsule endoscopy; and d) computed tomography enterography.   "
209240|NCT00576017|"     To show, using the analgesic WHO scale, that fentanyl-TTS may be directly used for treating     moderate to severe cancer pain in patients treated with NSAIDs, acetaminophen, or metamizole     (first step drugs) avoiding the second step, and may be at least as effective and safe as     currently used second step drugs, minor opioids.   "
209949|NCT00591799|"     The purpose of the study is to determine the safety and effectiveness of the Jarvik 2000     Heart as a bridge to heart transplantation in end-stage heart failure patients who are     approved heart transplant candidates.   "
209161|NCT00588367|"     1. Pancreatic CT perfusion with a biofeedback breathing belt worn by the participant, and          using novel post-processing techniques, is a reliable method which can be used to          differentiate between pancreatic cancer, chronic pancreatitis, and autoimmune          pancreatitis.        2. Pancreatic CT perfusion can be used to monitor patients undergoing decompression          treatment (endoscopic retrograde cholangiopancreatography with stent placement) for          painful chronic pancreatitis, and the change in the pancreatic perfusion parameters          correlate with the change in the pain parameters (pain scale and analgesic use).        3. Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at          specific time points to replace the continuous scanning.   "
209162|NCT00588380|"     Glucagon-like Peptide-1 (GLP-1) is an important incretin hormone which acts as a powerful     insulin secretagogue. Defects in GLP-1 synthesis and secretion are thought to be part of the     pathogenesis of type 2 diabetes. Furthermore GLP-1 based therapy is an important part of the     therapeutic armamentarium for the treatment of type 2 diabetes. The GLP-1 receptor (GLP1R) is     the principal site of action of GLP-1 and GLP-1 receptor agonists like exenatide and     liraglutide. The gene coding for this receptor, GLP1R, is highly polymorphic and contains     numerous non-synonymous Single Nucleotide Polymorphisms (nsSNPs) which could potentially     alter response to endogenous or exogenous GLP-1 or GLP-1R agonists. Indeed there is some in     vitro data to support this concept. We propose to utilize a hyperglycemic clamp to test the     insulin secretory response to infused GLP-1 in healthy volunteers to determine the effect of     genetic variation in GLP1R on response to GLP-1.   "
209163|NCT00588393|"     This study will gather information on the safety of FolateScan and the ability of FolateScan     to detect inflammation in the joints and other organs in people with arthritis (rheumatoid     arthritis and osteoarthritis), systemic lupus erythematosus, multiple sclerosis, interstitial     pneumonitis, Crohn's disease as well as in healthy persons without these conditions.   "
209164|NCT00588406|"     To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED     patients with refractory acute asthma helps improve forced expiratory volume at one second     (FEV1) and decrease the need for hospitalization.   "
209165|NCT00588419|"     The purpose of this study is to evaluate the return of sensation in the breast(s) following     breast mastectomy with and without reconstruction. Four different sensations: touch,     vibration, superficial pain, and temperature will be evaluated. In addition, we will look at     factors that may contribute to the return of breast sensations.   "
209166|NCT00588432|"     The goal of this proposal is two-fold: (1) to further develop and validate a technology,     magnetic resonance elastography (MRE), for quantitatively imaging mechanical properties and     tension distribution in muscle and (2) to apply the technique for in vivo evaluation of     patients with four common, and clinically significant muscle disorders (spasticity, disuse     atrophy, myofascial pain and a metabolic myopathy). These studies will employ a magnetic     resonance imaging sequence with synchronous motion-sensitizing gradients to map propagating     shear waves in the muscle. The technique will assess the mechanical properties of the muscle     and its tension distribution. Specifically, the study can be divided into three specific     aims. Aim 1: Optimize MRE methods of acquisition and analysis for the assessment of muscle,     including electromechanical drivers, data acquisition techniques, and methods for image     analysis. Advanced techniques for very rapid MRE assessment of muscle will continue to be     developed. Aim 2: Validate the MRE assessment of muscle properties and tension with phantom,     ex-vivo muscle, and Finite Element Modeling (FEM) techniques. Finite Element Analysis will be     performed by using both phantom and bovine muscles to better correlate MRE wave-length     findings as function of muscle properties, tension and fiber architecture. Aim 3: Study In     Vivo Normal and Abnormal Muscle. The MRE technique will be applied in vivo to provide     elastographic images of abnormal muscle with known disorders. The patient groups chosen for     study are each important in their own right, and furnish unique information across the     spectrum of muscular disease and dysfunction. Groups to be studied include individuals with     new onset of spasticity following an ischemic, hemispheric stroke, disuse atrophy as a result     of immobilization, metabolic (hyperthyroid) myopathy and myofascial pain for trigger point     identification. The overall hypothesis of this work is that will bring benefits to both basic     research and clinical care.   "
209167|NCT00588445|"     The purpose of this research study is to:        -  see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before          surgery        -  see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene        -  see if patients whose tumor does shrink with gefitinib treatment are more likely to have          a mutation in a certain part of the EGFR gene        -  see if the pattern of protein expression in the blood is related to the tumor's          sensitivity or resistance to gefitinib treatment.        -  see if expression of certain genes in the tumor are related to the tumor's sensitivity          or resistance to gefitinib treatment.   "
209168|NCT00588458|"     The reason for this study is to see if a new radiologic technique called computerized     tomographic cholangiography (CT cholangiography) could be helpful to demonstrate the bile     ducts features and measure the amount of space of bile duct canals that should be filled with     bile fluid. It may be useful to find out how well these findings correlate with the     previously known clinical predictors in term of the clinical outcomes that will happen in the     future for patients with primary sclerosing cholangitis (PSC).   "
209171|NCT00588497|"     Tubal sterilization is the most prevalent form of contraception in the United States and the     world. Currently, approximately half of these are performed with a laparoscope and half     through a mini-laparotomy after delivery. Micro-insert hysteroscopic sterilization system     received FDA approval for elective sterilization in 2003. Compared to other forms of female     sterilization, this procedure is minimally invasive and does not require entering the     abdominal cavity. In addition, it is at least as effective in preventing pregnancy as other     forms of tubal occlusion. Given the distinct advantages of this method, it could become the     preferred method of tubal sterilization for physicians and their patients. Currently, there     is no published data concerning the appearance of the micro-inserts system using other     imaging modalities that are commonly used in gynecologic practice. As the use of this device     becomes more widespread it will be more commonly encountered in radiographic imaging     performed as part of routine patient care. The main objective of this study is to provide     important descriptive data concerning the ultrasonographic and x-ray appearance of the     micro-insert hysteroscopic sterilization device. An additional objective of this study is to     identify characteristics on plain film and ultrasound (US) that correlate with tubal     occlusion or patency.   "
209212|NCT00589095|"     The purpose of this study is to determine whether dynamic contrast enhanced MRI (DCE MRI) and     high diffusion weighting MRI may be used to distinguish between favorable and unfavorable     responses to therapy of glioblastoma multiforme. Imaging data will be correlated with     histopathologic findings and clinical responses to radiation therapy with or without     chemotherapy.   "
227372|NCT00822198|"     The purpose of this study is to assess the effect of vibration of the plantar surface of the     foot on peripheral neuropathy.   "
209172|NCT00588510|"     This study focusses on finding out if osteosarcoma can be detected in blood. The cells will     be measured by a new laboratory technique called the polymerase chain reaction. This new     technique can identify one tumor cell among one million normal cells. Using this technique     Memorial Sloan-Kettering Cancer Center research doctors may be able to detect tumor cells     that could not be identified any other way. This test will be in addition to cancer treatment     and will not replace any other test used normally. As this technique is still unproved the     results will not be given to patients or patient's doctors and will not be used to change     cancer treatment.   "
209173|NCT00588523|"     The purpose of this study is to see how effective treatment of high doses of chemotherapy is     for your tumor. We will also be looking at the side effects and risks of this treatment.      You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy     tumor cells, but it can also destroy normal bone marrow cells. These cells produce white     blood cells (which fight infection), red blood cells (which carry oxygen) and platelets     (which allow your blood to clot). With too few of these cells there is a serious risk of     infection and bleeding.      Therefore, before treatment begins, we will collect some of your own blood cells, called     peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs     are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs     are thawed and given back to you. These healthy PBPCs will replace the blood cells that the     high dose chemotherapy destroys and allow your bone marrow to recover and produce blood     cells. In a prior study we treated 69 patients in a similar way. More than half were able to     avoid or delay brain radiation. This new study will use a different high dose chemotherapy     regimen.   "
209174|NCT00588536|"     The objective of this study is to determine the incidence of complete and partial response     and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated     with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX).   "
209175|NCT00588549|"     This study aims to determine whether a test, called the PET scan, may be useful in     determining if there are additional locations of cancer not otherwise detectable by other     tests.      The PET scan is a nuclear medicine imaging study that measures how much radioactive sugar is     used by your tumor. The study will compare pictures of the cancer from the PET scan to other     x-ray exams, such as a CT scan, as well as to what your doctors find at the time of surgery.     If the study results show that the PET scan gives us a good idea of what is happening to the     tumor, then it may be useful in deciding which patients with colorectal metastases to the     liver should be operated on and what operation should be performed.      Additionally, by comparing the results of PET scans with the other studies that will be     performed as part of your care, we will try to determine which test best tells us which     patient is most likely to benefit from surgery.   "
209176|NCT00588562|"     The purpose of this study is to collect medical information from a large number of patients     in many areas of the world with primary hyperoxaluria (PH), Dent disease, Cystinuria and APRT     deficiency. This information will create a registry that will help us to compare similarities     and differences in patients and their symptoms. The more patients we are able to enter into     the registry, the more we will be able to understand the Primary Hyperoxalurias,Dent disease,     cystinuria and APRT and learn better ways of caring for patients with these diseases.   "
209177|NCT00588575|"     This study is being done to see if a new device, called near-infrared Raman spectroscopy, can     provide similar information as that obtained from taking biopsies of the lining of your     Barrett's esophagus   "
209178|NCT00588588|"     The reported incidence of ventilator associated pneumonia (VAP) is 10 to 15 per 1,000     ventilator days. VAP leads to an excess cost exceeding $40,000 per patient and is associated     with a crude mortality rate as high as 76%. The clinical criteria for the diagnosis of VAP     have low specificity and may lead to unnecessary antibiotic use. The Clinical Pulmonary     Infection Score (CPIS) and bronchoscopic approaches lower unnecessary antimicrobial use,     antimicrobial resistance, and superinfection compared to the traditional clinical criteria.      Based on the available evidence and local microbiology data, we have developed a VAP     management protocol guided by CPIS or bronchoalveolar lavage (BAL) in adults with suspected     VAP. These two approaches have not been compared against each other. Although the diagnostic     studies in the CPIS guided approach are inexpensive and easily available, BAL has the     potential to minimize the unnecessary use of antibiotics and reduce the development of drug     resistant pathogens.      In this study, we propose to test the hypothesis that BAL leads to a reduction in antibiotic     use compared to CPIS in patients with suspected VAP. The study design will be a randomized,     clinical trial comparing CPIS versus BAL. The primary outcome measure will be antibiotic     utilization. The secondary outcome measures will be mortality, morbidity, development of     resistant pathogens and superinfection and infection related financial burden.      Completion of this trial will help us identify the best approach to avoid unnecessary     antibiotic utilization and minimize the development of resistant pathogens (with their     associated morbidity and mortality) in critically ill patients.   "
209179|NCT00588614|"     This study is being done to find out if breast cancer detection will be improved using a     short MRI (magnetic resonance imaging) scan, in addition to mammography, in patients who are     at an increased risk of developing breast cancer.   "
209183|NCT00588666|"     Gemcitabine and carboplatin are two standard chemotherapy drugs used to treat tumors of the     urothelial tract. These drugs do not shrink tumors in all patients and when they do, it is     generally for a limited amount of time. This has led scientists to look for different ways to     treat cancer.      New drugs have been developed to treat cancer that work differently than standard     chemotherapy drugs. One new class of drugs are called 'angiogenesis-inhibitors'. These drugs     attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's     source of oxygen and nutrients and prevent the tumor from growing. Bevacizumab is an     anti-angiogenic drug.      In some other cancers such as colon cancer and lung cancer, combining bevacizumab with     standard chemotherapy shrinks tumors in a greater proportion of patients and makes patients     live longer than using standard chemotherapy alone. This has never been tested in urothelial     cancer and we do not know if bevacizumab will have the same effects in this disease. The     purpose of this study is to find out what effects, good and/or bad, the combination of     gemcitabine, carboplatin, and bevacizumab has on you and your cancer.   "
210681|NCT00600678|"     Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by     using the paracetamol absorption method in healthy volunteers.   "
209185|NCT00588692|"     Heart failure (HF) is the leading cause of hospitalization among Americans over the age of 65     years, affecting greater than 5 million in the U.S. alone. Significant improvements in     morbidity and mortality have been achieved through the use of medications that antagonize     adverse neurohormonal signaling pathways, particularly therapies that reduce left ventricular     (LV) afterload.      Vascular stiffness increases with aging, contributing to the increase in cardiac load. One     important repercussion of such stiffening is an increase in pulse wave velocity. As the     incident pressure wave generated by cardiac ejection encounters zones of impedance mismatch     (such as arterial bifurcations), part of the wave is reflected backward, summing with the     incident wave, increasing central blood pressure (CBP). With normal aging, hypertension, and     heart failure, increased wave velocity causes the reflected wave to reach the heart earlier,     in mid to late systole, considerably increasing late-systolic load, impairing cardiac     ejection, and diastolic relaxation in the ensuing cardiac cycle.      The magnitude of this reflected pressure wave can be quantified by the augmentation index     (AIx). The use of vasoactive agents which antagonize this increase in late systolic load (and     AIx) may prove useful in the treatment of heart failure, by facilitating cardiac ejection     during late systole when reflected pressure waves predominate. However, it has never been     conclusively shown in humans that CBP-targeted therapy is useful in the management of HF.      LV afterload, measured centrally in the ascending aorta, may differ considerably from     brachial cuff-measured pressure, and has traditionally required invasive hemodynamic     assessment to determine, limiting the applicability of techniques targeting CBP and     late-systolic load. Recently, a novel, hand-held tonometer (SphygmoCor, Atcor Medical) has     been developed for the noninvasive assessment of CBP. This pencil-like device is applied over     the radial artery, and uses a validated mathematical transformation to derive central aortic     pressure. This device has received FDA approval for clinical use in the assessment of central     pressures. However, it remains unknown whether knowledge of CBP and late-systolic load (AIx)     confers any clinically-significant incremental benefit in the management of patients with     heart failure. The primary objective of the proposed investigation will be to determine if     this assessment might have such a role.   "
209186|NCT00588705|"     The purpose of this study is to first understand how MSKCC Clinical Genetics Service doctors     talk to women with breast cancer about any genetic risks they might carry, and if they help     women to think about what they might say, in turn, to their relatives, especially their     daughters.      A second part of the study asks women for their opinions about when and how their daughters     should be told about any genetic risks.      All of this will help us develop teaching methods to help our doctors improve the way they     talk about genetic risk when women with breast cancer have adolescent daughters.   "
209187|NCT00588718|"     Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the     intestine that occurs most often in premature babies. If it progresses, the wall of the     intestine may perforate, spilling bacteria and stool into the abdomen. Parts or all of the     intestine may die. Despite 30 years of clinical studies, the cause of NEC remains unknown.      In this study, we will be conducting an independent case-control validation study to verify     the diagnostic and prognostic biomarker panels, develop validated biomarkers on boisensors in     preparation for prospective validation studies, and conduct independent prospective     validation of biosensor based biomarker panels on clinical samples.   "
209188|NCT00588731|"     This study is a six-week, randomized, placebo-controlled, fixed dose trial comparing     cannabidiol Vs. placebo added to a stable dose of antipsychotic medications in patients     diagnosed with schizophrenia.   "
209189|NCT00588757|"     OptEase filters are easier to retrieve but the dwell time is shorter than the Gunter filters.     There are more thrombi on the OptEase than on the Gunter at the time of retrieval. OptEase     filter has a better infitration capabillity due to its diamond shape. OptEase filters will     hjave more IVC occlusions as a complication.   "
209191|NCT00588783|"     The purpose of this study is to compare the clinical outcomes of using an I-beam or cruciate     tibial component in total knee replacement.   "
209192|NCT00588796|"     To study the fibrinogen metabolic changes in relation to coagulation disorder in patients     with severe burns and trauma injuries. As a result of the burn or trauma injury breakdown of     fibrinogen is accelerated.   "
209193|NCT00588809|"     This phase II clinical trial is studying how well selumetinib works in treating patients with     recurrent or refractory acute myeloid leukemia. Selumetinib may stop the growth of cancer by     blocking some of the enzymes needed for cell growth   "
209208|NCT00589030|"     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near     a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be     effective treatment for liver cancer that cannot be removed by surgery.      PURPOSE: To provide expanded access and study the side effects of yttrium Y 90 glass     microspheres in treating patients with liver cancer that cannot be removed by surgery.   "
221493|NCT00743899|"     The aim of this study was to compare conservative versus aggressive strategy in patients with     intermediate lesions with angiography guidance alone.   "
209194|NCT00588822|"     This study was done to find out if the investigational medication, rituximab, could help     relieve the symptoms of peripheral neuropathy (such as numbness [abnormal protein in the     blood] and weakness of the lower and upper extremities) in people who have monoclonal     gammopathy of undetermined significance and people with a symptomatic or smoldering     Waldestrom macroglobulinemia.      Rituximab is an antibody which attacks a particular type of white blood cell (B Cell). By     targeting the B-cells which make the abnormal protein which is involved in causing the nerve     trouble, it is hoped that damage to nerve fibers will be stopped and improvement will be     allowed to proceed.   "
209195|NCT00588835|"     The purpose of this study is to determine whether aprepitant can be used in the Cisplatin -     Etoposide chemotherapeutic regimen.   "
209196|NCT00588848|"     The purpose of this study is to determine if an Autoadjusting CPAP machine is better than the     regular CPAP machine in treatment of Obstructive Sleep Apnea in the postoperative setting.   "
209197|NCT00588861|"     The purpose of this study is to document the clinical outcomes of several devices used in     total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular     shell, and Simplex® or Palacos® bone cement.   "
209198|NCT00588874|"     The purpose of this pilot study is to generate preliminary data regarding the skeletal     effects of age-related changes in calcium and vitamin D metabolism in older men.   "
209199|NCT00588887|"     The purpose of this study is to compare range of motion, Knee Society Scores, and duration of     surgery for different total knee prostheses.   "
209200|NCT00588900|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving irinotecan together with cediranib may kill more tumor cells.      PURPOSE: This phase II clinical trial is studying how well giving irinotecan together with     cediranib works in treating patients with metastatic colorectal cancer that did not respond     to previous oxaliplatin, fluoropyrimidine, and bevacizumab.   "
209201|NCT00588913|"     RATIONALE: Cellular adoptive immunotherapy uses a person's white blood cells that are treated     in the laboratory to stimulate the immune system in different ways and stop tumor cells from     growing. Aldesleukin may help the laboratory-treated white blood cells stay in the body     longer. Drugs used in chemotherapy, such as zoledronic acid, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving cellular adoptive immunotherapy together with interleukin-2 and zoledronic acid may     kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects of giving cellular adoptive     immunotherapy together with aldesleukin and zoledronic acid and to see how well it works in     treating patients with stage IV kidney cancer and lung metastases.   "
209202|NCT00588926|"     Deep brain stimulation is commonly used for the treatment of movement disorders. Electrode     positioning is usually performed under local anesthesia in fully awake patients. The     procedure is uncomfortable to the patients who has to remain motionless during the whole     surgery. Previous reports of electrode positioning under general anesthesia was found to be     less accurate. This result was probably due to the effect of the anesthetics on the     electrical activity of the basal ganglia.      The purpose of this study is to detect possible changes in the electrical activity of the     basal ganglia related to remifentanil sedation. electrical activity of single neurons will be     recorded before, during and after sedation.   "
209203|NCT00588939|"     Heartburn or reflux disease affects about 20% of Americans. 50 - 70% of people who have     endoscopy for reflux disease have a normal appearing esophagus. Confocal Laser Microscopy     allows us to see changes in the cells not visable during routine endoscopy. Whe goal of this     study is to identify the use of this new technique in diagnosing reflux in patients who have     normal appearing esophagus.   "
209204|NCT00588952|"     The proposed study is the first to explore the contribution of brain glutamate systems, a     major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study     may lead to an enhanced understanding of the underlying neurobiological mechanism in     high-risk individuals that may lead to the transition from moderate to excessive use of     alcohol.   "
209205|NCT00588965|"     Background. In congenital long QT syndrome type 1 (LQT1), episodes of ventricular tachycardia     are usually triggered by exercise and can be prevented in most patients by beta-blocker     therapy. In addition, LQT1 associated with a normal resting QT interval can be unmasked by     the abnormal QT response to exercise testing (failure of the QT interval to shorten     normally). Preliminary data from our laboratory show that the exercise QT intervals of     patients with LQT1 are partially normalized by beta-blocker therapy. It is still currently     not known if beta-blockers modify the QT/heart rate relationship (a primary effect on     repolarization) or if the normalizing effect is due to the inability of subjects on     beta-blockers to attain sufficiently high workloads (due to reduced heart rate) for     prolongation to occur. Moreover, the physiologic response of the exercise QT interval to     beta-blockers in healthy control subjects is not known.      Objective. The objective of this study is to define the impact of beta-blocker therapy on the     QT response to exercise and recovery in normal subjects.      Methods. Approximately 36 healthy adult subjects age-matched to previously studied LQT1     subjects will undergo 1) screening history, 2) two weeks of beta-blocker therapy ending in an     exercise test, and 3) two weeks of placebo therapy ending in an exercise test. Beta blocker     and placebo will be given in random order in a double-blind fashion. The QT response to     exercise and recovery will be compared between drug-free and beta-blocker-treated states.     These data will be compared to those previously collected for LQT1 subjects.      Implications. These results will provide new information about the effect of beta-blocker     therapy on repolarization parameters in normal subjects, and will provide a context in which     to interpret the previous findings that beta-blocker administration modifies the QT response     to exercise in LQT1 subjects.   "
209206|NCT00588978|"     The purpose of this pilot study is to examine the effect of diet and/or exercise-induced     weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin     levels and sex steroids in obese postmenopausal women.   "
209207|NCT00588991|"     This phase I trial is studying the side effects and best dose of veliparib when given     together with topotecan hydrochloride with or without carboplatin in treating patients with     relapsed or refractory acute leukemia, high-risk myelodysplasia, or aggressive     myeloproliferative disorders. Veliparib may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan     hydrochloride and carboplatin, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Giving veliparib together with     topotecan hydrochloride and carboplatin may kill more cancer cells.   "
209209|NCT00589043|"     The purpose of this study is to evaluate the sensitivity and specificity of the CTLM system     when used adjunctively with mammography compared to mammography alone in the heterogeneously     and extremely dense breast population.   "
209210|NCT00589056|"     RATIONALE: Nelfinavir may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells.     Nelfinavir may make tumor cells more sensitive to radiation therapy. Drugs used in     chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving nelfinavir     together with radiation therapy, cisplatin, and etoposide may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir when     given together with radiation therapy, cisplatin, and etoposide and to see how well they work     in treating patients with stage III non-small cell lung cancer that cannot be removed by     surgery.   "
209211|NCT00589082|"     Overall results in the treatment of middle aged adults acute myelogenous leukemia (AML) are     substantially improved in the last decade, with complete remission (CR) rates established to     values of 70 to 80per cent and also encouraging long-term outcome, especially in patients who     can tolerate intensified post remissional treatment strategies. On the contrary, there has     been little progress in the treatment of older patients. In these patients the response rate     generally range between 40 and 60per cent, and overall survival at 2 years is often less than     10 per cent.      Usually, a combination of anthracyclines daunomycin DNR or doxorubicin and cytarabyne Ara-C     has been utilized for the remission-induction treatment, with schedules similar to those     utilized in younger cases, for patients eligible to intensive treatments. Variation of the     dose of DNR has not brought any significant benefit. The EORTC HOVON randomized trial AML9     compared two drugs in induction for previously untreated patients. DNR versus Mithoxantrone     (MTZ). MTZ induction therapy produces a slightly better CR rate than DNR-containing regimen     (47per cent vs 38per cent, P equals 0.069), without any significant effect on remission     duration and survival. The DFS probability between the two treatment arms was not different.     The median DFS estimates were 39 weeks in both groups. The DFS rate at 5 years was 8per cent.     Also the duration of survival was similar (p equals 0.23) in the two treatment groups. Median     survival estimates were 36 weeks (DNR) and 39 weeks (MTZ). The percentage of patients still     alive at 5 years were 6per cent and 9per cent respectively.   "
209213|NCT00589108|"     Pain, weakness, instability, and progressive dysfunction are the hallmarks of arthritis of     the knee. Total knee replacement may frequently be the only therapeutic intervention to     provide adequate improvement in pain and function. Both fixed bearing and mobile bearing     knees have a long track record of clinical success. Mobile bearing designs have theoretical     advantages of decreased contact stresses on the tibial tray, decreased polyethylene wear, and     improved range of motion relative to fixed bearing designs. These theoretical advantages may     become especially important in the young patient who requires a knee arthroplasty. This study     will attempt to see if there is a clinical difference in outcome between mobile bearing and     fixed bearing knee arthroplasties in patients who require total knee replacement.   "
209214|NCT00589121|"     RATIONALE: Image-guided radiation therapy uses high-energy x-rays to kill tumor cells.     Specialized radiation therapy that delivers a lower dose of radiation directly to the tumor     may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This phase II trial is studying the side effects and how well image-guided radiation     therapy works in treating patients with primary soft tissue sarcoma of the shoulder, arm,     hip, or leg.   "
209215|NCT00589134|"     Women are at greater risk for exercise-induced hyponatremia (low blood sodium concentration)     and this risk has been attributed to their lower body weight and size, excess water ingestion     and longer racing times relative to men. While these factors contribute to the greater     incidence of hyponatremia in women, it is likely that their greater levels of estradiol in     plasma and/or tissue also play a role in increasing the risk of hyponatremia in women. More     importantly, estradiol may also leave women more susceptible to the extreme consequences of     hyponatremia (i.e. brain damage, death). Hyponatremia is generally attributed to     inappropriately elevated levels of the hormone arginine vasopressin (AVP). AVP is the most     important hormone controlling water retention in the kidney. Earlier studies in our     laboratory have demonstrated that estradiol lowers the threshold for thirst sensation and AVP     release during exercise. The purpose of these studies is to test the hypotheses that in women     with a history of hyponatremia, estradiol lowers the thresholds for thirst and AVP release,     leading to greater fluid retention, lower blood sodium concentration during endurance     exercise in the heat. However, we further hypothesize that progesterone administration along     with estradiol administration will attenuate the effect of estradiol on the regulation of     thirst and AVP, normalize fluid retention, and serum sodium concentration during endurance     exercise in the heat. In women without a history of hyponatremia, we expect that estradiol     administration will lower the thresholds for thirst and AVP release, but will not increase     fluid retention or reduce blood sodium concentration during endurance exercise in the heat.     We hypothesize that progesterone administration along with estradiol administration will     attenuate the effect of estradiol on thirst and AVP, but have no effect on fluid retention or     serum sodium concentration during endurance exercise in the heat. To test these hypotheses,     women will perform endurance exercise in the heat under three hormonal conditions: 1) during     Gonadotropin-releasing hormone (GnRH) antagonist alone--which will suppress estradiol and     progesterone; 2) during GnRH antagonist+estradiol; and 3) during GnRH antagonist+estradiol+     progesterone. During exercise, fluid will be replaced with either water or a     carbohydrate-electrolyte beverage (random assignment).   "
209216|NCT00589147|"     SUMMARY A prospective, randomized, single-blinded clinical trial is proposed to compare three     tibial tray designs for patients undergoing total knee arthroplasty. This study is designed     to address the clinically important issues of tibial component modularity and fixation in     total knee replacement. The Zimmer NexGen Legacy knee system is an FDA approved device and in     this study will be used with 1) a modular tibial tray inserted with cement and 2) a     non-modular tibial tray inserted with cement, and 3) a non-modular tibial tray inserted     without cement. The insertion of total knee components without cement has been done     clinically for over 20 years but has not been specifically approved by the FDA. Thus     treatment arm 3, a non-modular tray inserted without cement, would involve the so-called     off-label use of the device.      136 cases will be assigned to each arm of the study. Each patient will be assessed two months     after surgery, one year after surgery, two years after surgery, five years after surgery, and     every three to five years thereafter. The principal outcome measures will be the Knee Society     Clinical rating scale, the SF-36 and the presence of significant lucent lines.. These     measures will be compared among patients in the 3 trial arms at 5 years post surgery (or at     the last follow-up point for those who drop out or become lost to follow-up). The Knee     Society scores and SF-36 scores will be analyzed using analysis of variance models Rates of     significant lucencies, perioperative mortality, as well as complications such as deep vein     thrombosis, pulmonary embolus, neurovascular complication, and infection will be compared     among the groups using chi-square tests . Rates of revision surgery will be compared among     the groups using survivorship methods.      PURPOSE The primary aim of the study is to compare the results obtained with each of three     tibial designs for patients undergoing total knee arthroplasty. Those results will be     measured with disease-specific (Knee Society Scores), global (SF-36), and outcome measures.     Radiographic results consisting of standing alignment, lateral and skyline views of the     surgical knee will be recorded and analyzed. Completion of the intial investigation will     occur at the 5-year interval after the last enrolled patient.   "
209238|NCT00589459|"     The primary goal of this study is to measure the prevalence of undiagnosed     pre-diabetes/diabetes among women hospitalized with acute coronary syndromes (ACS) compared     to men. Inpatients with confirmed ACS (and no known prior history of diabetes) are invited to     return to the Yale Hospital Research Unit 6-8 weeks after hospital discharge for an oral     glucose tolerance test to identify individuals with pre-diabetes and diabetes.   "
209217|NCT00589173|"     Americans only receive 50% of indicated preventive services. We hypothesize that an     interactive preventive health record (IPHR) will increase the delivery of recommended     screening tests, immunizations, and counseling. The IPHR will function as a highly     sophisticated personal health record for prevention, linking patients directly to their     health information in the electronic record of their primary care physician. The functions of     the IPHR will extend beyond those of personal health records by providing tailored     recommendations, links to educational resources and decision aids, and patient and clinician     reminders. Year one will focus on updating and refining an existing IPHR prototype. The     second and third year, through a randomized controlled trial, will examine the effectiveness     of the IPHR. Outcomes will include (1) whether the IPHR increases the delivery of recommended     preventive services, (2) whether participants use the IPHR, and (3) whether the IPHR     increases shared decision-making and improves clinician-patient communication. The study will     take place in seven primary care practices in the Virginia Ambulatory Care Outcomes Network     (ACORN) that utilize a common electronic medical record (EMR). A randomly selected sample of     5,500 of the practices' 228,000 patients, stratified by age and gender, will be assigned in a     one-to-one ratio to receive a request from their clinician to use the IPHR (intervention     group) or receive usual preventive care (control group). A Preventive Services Survey,     which uses standardized questions to evaluate the delivery of preventive care, will be mailed     to 4,500 patients and the CAHPS Clinician & Group Survey will be mailed to 1,000 patients.     Surveys will be mailed pre-intervention, 6 month post-intervention, and 18 months     post-intervention. Delivery of preventive care will be measured by the Preventive Services     Survey and EMR data, while shared decision-making and clinician-patient communication will be     measured by the CAHPS survey. The change from baseline to 6 and 18 months post-intervention     for the control and intervention groups will be compared.   "
209218|NCT00589186|"     RATIONALE: Vaccines made from a gene-modified virus and a person's dendritic cells may help     the body build an effective immune response to kill tumor cells. Celecoxib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine     therapy together with celecoxib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with     celecoxib works in treating patients with metastatic nasopharyngeal cancer.   "
209219|NCT00589199|"     The purpose of the present study is to assess the utility of abdominal muscle stimulation to     provide large positive airway pressures and expiratory airflow thus simulating cough.     Restoration of cough in spinal cord injured patients may reduce the incidence of respiratory     complications such as atelectasis, respiratory tract infections and respiratory failure.   "
209220|NCT00589212|"     This study has been designed to compile information on the efficacy of the GliaSite RTS     combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.   "
209221|NCT00589225|"     This study will help us determine whether certain genetic mutations, more than others, are a     cause of more severe disease in Primary Hyperoxaluria.   "
209574|NCT00585832|"     The purpose of this study is to examine the long term effects of a 24-week clinically-based     behavioral nutrition intervention emphasizing the DASH diet compared to routine nutrition     care on changing diet quality, blood pressure, hypertension status, and vascular function in     adolescents with elevated blood pressure.   "
209222|NCT00589238|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, doxorubicin, cyclophosphamide, and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. It is not yet known whether combination chemotherapy     is more effective with or without carboplatin in treating breast cancer.      PURPOSE: This randomized phase II trial is studying giving paclitaxel together with     doxorubicin and cyclophosphamide to see how well it works compared to giving paclitaxel     together with doxorubicin, cyclophosphamide, and carboplatin in treating women with locally     advanced breast cancer that can be removed by surgery.   "
209223|NCT00589251|"     The primary objective of the study is to evaluate the equivalency of the skin test reactivity     to penicilloate prepared by our new method of penicilloate preparation versus our old method     of penicilloate preparation. The secondary objective of the study is to evaluate the     significance of the different diastereoisomers of penicilloate on skin test reactivity.   "
209224|NCT00589264|"     Zinc is necessary for growth and development, including the central nervous system, and zinc     deficiency which is common in resource-poor settings, may adversely affect social,     behavorial, cognitive and sensorimotor development. The project, located in Lima Peru,     utilizes an experimental model in which children receive 10 mg supplemental zinc (or not)     daily along with 10 mg iron and 1/2 mg copper from 6 months of age to 18 months of age.     Beginning at 6 months of age, and at 9, 12, and 18 months, children are evaluated in     multiples aspects of development. Children are also followed for their diet, growth, and     health status. We hypothesize that children in this setting in which the diet is low in zinc     who receive supplemental zinc will have better information processing skills, sensorimotor     and behavioral development than their counterparts who do not receive supplemental zinc.   "
209225|NCT00589277|"     The purpose of this study is to compare Yale coaching counseling and Yale print     information to standard care counseling and standard care print information. We hypothesize     that Yale coaching counseling and Yale information will produce higher abstinence rates     than standard care counseling and standard care information. We will use these data to     determine effect size estimates for a large scale study.   "
209226|NCT00589290|"     Background:        -  Cisplatin-containing chemotherapy is the standard treatment for advanced tumors of the          thymus that cannot be removed surgically.        -  New treatment options are needed for patients with advanced tumors of the thymus that do          not improve with cisplatin-containing therapy.        -  Belinostat is a drug that inhibits enzymes called histone deacetylase. Histone          deacetylase inhibitors have shown promising activity in many cancers and may be useful          in treating patients with thymic tumors.      Objectives:      -To assess the safety and effectiveness of belinostat for treatment of malignant thymic     tumors in patients who failed after standard treatment.      Eligibility:      -Patients 18 years of age or older with an advanced thymic tumor that has progressed after     treatment with platinum-containing chemotherapy.      Design:        -  Patients receive belinostat treatment in 21-day cycles. The drug is given as an infusion          through a vein during days 1 through 5 of each cycle. Treatment cycles continue as long          as the medicine is tolerated and the cancer does not worsen.        -  Patients have a physical examination and several blood tests during every cycle.        -  Patients have an electrocardiogram every cycle before starting the belinostat infusion          and again on the last day of the infusion.        -  Patients undergo computed tomography (CT) or other imaging test, such as ultrasound or          MRI, every two cycles to evaluate the response of the tumor to treatment.        -  Tumor tissue obtained from a previous biopsy is used for research purposes.   "
209227|NCT00589303|"     The purpose of this study is to determine whether early atrioventricular node (AVN) ablation     with pacing device therapy will reduce death and hospitalization when compared to the     conventional drug therapy in elderly patients with recurrent and symptomatic atrial     fibrillation (AF).   "
209239|NCT00576004|"     To evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in     patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ     prolapse (POP) repair   "
209228|NCT00589316|"     This phase I trial studies the side effects and best dose of iodine I 131monoclonal antibody     BC8 when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation,     and donor bone marrow transplant, and to see how well they work in treating patients with     acute myeloid leukemia or acute lymphoblastic leukemia that has spread to nearby or other     places in the body (advanced), or high-risk myelodysplastic syndrome. Giving chemotherapy     drugs, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before     a donor bone marrow transplant helps stop the growth of cancer or abnormal cells and helps     stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled     monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells     and carry cancer-killing substances to them without harming normal cells. When the healthy     stem cells from a donor are infused into the patient they may help the patient's bone marrow     make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving cyclophosphamide together with mycophenolate mofetil and tacrolimus after the     transplant may stop this from happening. Giving a radiolabeled monoclonal antibody together     with donor stem cell transplant, fludarabine phosphate, cyclophosphamide, mycophenolate     mofetil, and tacrolimus may be an effective treatment for advanced acute myeloid leukemia,     acute lymphoblastic leukemia, or myelodysplastic syndromes.   "
209257|NCT00576238|"     Topical steroid creams as well as moisturizing creams are important parts of the treatment     strategy of atopic eczema. This study aims to investigate the tolerance of a new strong     steroid cream in comparison to an already marketed reference cream with equal amount of     active but with different cream vehicle. The second part of the study will investigate the     possible preventative property of a moisturizing cream on skin that has been previously     cleared from eczema.   "
209258|NCT00576251|"     The purpose of this study is to describe the differences in efficacy between TOBRADEX     Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the     treatment of ocular inflammation and infection associated with blepharaconjunctivitis   "
209259|NCT00576264|"     The purpose of this research study is to determine the genotype (genetic composition) and     phenotype (physical appearance) of cells derived from the abdominal cavity to determine     whether stem cells are present.   "
209229|NCT00589329|"     Preterm birth, its causes, prevention, complications and ramifications persist as an     important focus of obstetrical research. In the United States 11.8% of all live births occur     prior to 37 weeks gestation. As many as 45% of these deliveries will have been proceeded by     preterm labor with intact membranes.(2) Both preterm labor and preterm premature rupture of     membranes have both been associated with evidence intrauterine infection. While antibiotic     treatment in conservative management of preterm PROM remote from term has been shown to     significantly prolong pregnancy and reduce infant morbidity, (16) data regarding the     effectiveness of antibiotics for pregnancy prolongation in preterm labor are inconsistent.     (3-15) Currently, narrow spectrum antibiotics (penicillin or clindamycin) are given prior to     delivery to reduce the risk of neonatal Group B Beta Streptococcus (GBS) sepsis, however     broad spectrum antibiotic treatment of women with preterm labor for pregnancy prolongation is     not recommended.      Review of the literature regarding antibiotic treatment for pregnancy prolongation in preterm     labor reveals that most studies utilized single agent therapy, and no study has evaluated the     use of antibiotics for pregnancy prolongation in women with an advanced cervical exam (>4cm).     While a number of studies have shown significant pregnancy prolongation in unselected     populations,(5,12,13) only one study of 12 reviewed was able to show a neonatal benefit to     adjunctive antibiotic use.(12,20) Norman, et al was able to show a reduction in the incidence     of necrotising enterocolitis with the use of antibiotics. Given the number of studies in this     area, and the lack of supporting evidence, this likely represents an alpha error. Another     study by Svare et al was able to show a significant decrease in NICU admissions for women     treated with antibiotics in the setting of preterm labor, however no change was reported in     neonatal morbidities.      Our proposed study is designed to evaluate patients at particular risk for preterm delivery;     those with advanced cervical exam. In this randomized prospective controlled study, we intend     to examine the influence of adjunctive antibiotic use in preterm labor complicated by a     cervical exam of 4 cm or greater. We plan to compare a study group receiving broad-spectrum     antibiotics with a control group that will not receive antibiotics for pregnancy     prolongation. Both groups will receive antibiotics for GBS prophylaxis as indicated. We hope     to see a delay in delivery in the study group as a primary outcome. Secondary outcomes will     include the use of steroids, neonatal complications including sepsis, intraventricular     hemorrhage, periventricular leukomalacea, mechanical ventilation and respiratory distress     syndrome, retinopathy of prematurity and necrotizing enterocolitis, and neonatal ICU stay.   "
209230|NCT00589355|"     The goal of this study is to determine whether markers of vascular inflammation (such as     c-reactive protein) can predict endothelial dysfunction (as measured by flow-mediated     dilation) in postmenopausal women with glucose intolerance compared to normal controls.   "
209231|NCT00589368|"     The purpose of this study is to examine if the strong hand can assist in the recovery of     muscle function in the weak hand after a stroke.   "
209232|NCT00589381|"     RATIONALE: Drugs used in chemotherapy, such as fenretinide Lym-X-Sorb™ , work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing.      PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide     Lym-X-Sorb™ in treating patients with recurrent or resistant solid tumors or lymphoma.   "
209233|NCT00589394|"     The lack of clear guidelines and studies addressing the proper response to the pneumococcal     vaccine (Pneumovax ®) has hampered our ability to diagnosis and care for our immunodeficiency     patients. Should an age matched normal response range to the Pneumovax ® be established, it     would have a profound impact in the diagnosis, safety and care of immunodeficiency patients.     Moreover, characterizing the B cell compartments response to the Pneumovax ® may better     delineate the mechanism of protective immunity from Pneumovax ® and provide an additional     tool for the diagnosis and care for immunodeficiency patients.   "
209234|NCT00589407|"     Neck pain is a common complaint in the general population affecting 10-15% of the general     population. females more than men. Known risk factors are: Trauma, Repetitive lifting of     heavy objects at work, driving vibrating vehicles, frequents diving from boards and smoking.     No study dealt with the possible role of unilateral loss of vision or hearing as a risk     factor for the development of neck pain. Intuitively, one might suspect that unilateral     blindness or deafness will lead to a tilted position of the head, in order to cover a better     visual/audio field. This position, in time, might lead to the development of neck pain.      Our hypothesis is that patients with unilateral blindness/deafness will suffer from neck pain     more frequently than the general population.   "
209235|NCT00589420|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving sorafenib together with docetaxel may kill more tumor cells.      PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how     well it works in treating patients with metastatic androgen-independent prostate cancer.   "
209236|NCT00589433|"     Rotator culf tears are common in the aging population and are a significant morbidity source.     The common knowledge is that the major tears do not heal and constantly expanding.Still since     the majority of the patients are old the acceptable therapy is conservative treatment.      Our objective is to estimate the accuracy of rotator culf tear utilizing an ultrasound.   "
209237|NCT00589446|"     The purpose is to test the value of embryoscopy in women with missed abortions after     recurrent miscarriages (at least two previous miscarriages) in the past. This project will     assess two functions of embryoscopy:-        1. Whether embryoscopy allows the diagnosis of structural anomalies (disorganized embryos).          This is a fetal cause of embryo loss which cannot be diagnosed by other means.        2. Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping.      However, it may be that embryoscopy will be found to have no advantage.   "
209241|NCT00576030|"     More than 80% of the population in the USA consume coffee each day. However there not many     studies on change of heart rate variability and placebo effects after consumption of coffee.      In our study we aim to test the following hypotheses:        1. Habitual caffeinated espresso coffee drinkers show an increase in blood pressure, heart          rate variability and parasympathetic activity (high frequency band) of the heart.        2. Non-habitual caffeinated espresso coffee drinkers show an increase of blood pressure.          The heart rate variability and the parasympathetic activity of the heart will decrease.        3. Caffeinated or decaffeinated espresso induces comparable changes in habitual or          non-habitual coffee drinkers.   "
209242|NCT00576043|"     Trainees (Residents in internal medicine), naive to real patient endoscopy, will be     randomized to receive either 3 weeks/2 hours per day of structured training for a total of 20     hours on the virtual endoscopy simulator GI-Mentor or no training before starting on-patient     endoscopy in the University of Vienna Medical School Endoscopy Unit. Patients satisfaction     and pain, technical accuracy and number of found/missed pathologies as well as average time     for successful endoscopy will be recorded. After one month or 50 supervised, self performed     endoscopies, trainees will be evaluated again with the above mentioned criteria during ten     consecutive investigations.   "
209243|NCT00576056|"     The purpose of this study is to determine if TACE plus Sorafenib will improve outcome in     patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery.   "
209244|NCT00576069|"     The purpose of this study is to evaluate the site and mechanisms responsible for expiratory     airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to     severe persistent expiratory airflow obstruction. Treatment will include inhaled     corticosteroids and long acting beta2agonists and long acting muscarinic antagonists. We are     interested in determining whether the large and/or small airways are the predominant site of     airflow limitation. We are also interested in determining whether intrinsic small airways     obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow     limitation and to what extent may be attributed to loss of lung elastic recoil vs decreased     airway conductance in peripheral airways. We are also interested to evaluate the role of     varying doses of inhaled corticosteroids to suppress large and small airway inflammation     using exhaled nitric oxide as surrogate markers of inflammation. For comparison purposes,     spirometry and measurements of exhaled nitric oxide will also be obtained if possible during     a naturally occurring exacerbation of asthma. High resolution thin section CT of the lung     will also be obtained. Analysis will evaluate integrity of the lung parenchyma as to absence     and or presence of emphysema and extent of emphysema using voxel quantification. We will also     investigate optical coherence tomography to detect clinically unsuspected emphysema. We will     also obtain autopsy material when available in asthmatics who expire. Will also measure serum     periostin as a marker of inflammation by collaborating with Genetech in San Francisco.   "
209245|NCT00576082|"     The aim of this study is to identify the species of Borrelia involved in the dermatologic     manifestations of Lyme borreliosis in France. Indeed, in Europe, as opposed to North America,     many bacterial species are involved in Lyme borreliosis. Yet, very few is known about the     prevalence and distribution of different bacteriological species that account for the disease     in France. Thus, this a nation-wide study in which all French dermatologists are invited to     participate. Every adult patient presenting with one of the cutaneous manifestation of Lyme     borreliosis: erythema migrans, lymphocytoma or acrodermatitis chronica atrophicans can be     included in the study. If the patient agrees participating, after information and written     consent, a cutaneous biopsy will be performed in order to isolate Borrelia by means of     culture and PCR. An estimated 400 biopsies should be performed within 2 years.   "
209246|NCT00576095|"     The primary objective of this study is to investigate the relationships among findings in     structural and functional neuroimaging, cognitive testing and HPA     (hypothalamic-pituitary-adrenal) axis dysregulation in psychotic depression.   "
209247|NCT00576108|"     This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo     in the treatment of postherpetic neuralgia.   "
209248|NCT00576121|"     This study is designed to look at the measurement and prediction of changes in the heart     following a heart attack.   "
209249|NCT00576134|"     Supplement pharyngolaryngeal deficient functions by insertion of a prosthesis with valves in     order to allow tracheotomy closing (when applicable) and / or to allow restoration of god     swallowing capacity. The secondary objective is to study the concept of a special valves     system for the development of an artificial larynx   "
209250|NCT00576147|"     The purposes of this study are:        1. To determine the sensitivity and specificity of the Near-Infrared Spectroscopy (NIRS)          measurements for identifying intracranial hematomas due to trauma.        2. To determine the reproducibility of the Near-Infrared Spectroscopy (NIRS) measurements          with different operators and at different centers   "
209251|NCT00576160|"     Many post Acute Coronary Syndrome(ACS) patients do not take their medications (including     aspirin) as prescribed, leading to an increase in mortality. Patients enrolled in this study     will be enrolled into one of two groups. Patients in the first group will have their     medication adherence measured, but will receive all other care as usual. Patients in the     second group will also have their medication adherence measured, but they will receive     telephone-delivered problem solving therapy (PST) in addition to their usual care. The two     groups will be combined to determine the Minimally Effective Dose (MED) and the Maximally     Tolerated Dose (MTD) for adherence to aspirin. The medication adherence of the PST group will     improve by 20% (<55% to >75%).   "
209252|NCT00576173|"     The purpose of this study is to evaluate the analgesic effectiveness and safety of 37.5mg     Tramadol hydrochloride/325mg Acetaminophen in the treatment of breakthrough pain in cancer     patients.   "
209253|NCT00576186|"     This research study is designed to evaluate the accuracy of the techniques that are used to     analyze heart function. The main purpose of this study is to analyze and compare three     different methods of assessment of regional and overall heart function.   "
209282|NCT00581971|"     This is a single-institution, open-label, non-randomized phase IB/II trial of celecoxib     administered concurrently with carboplatin, paclitaxel, and radiation therapy in patients     with locally advanced or recurrent squamous cell carcinoma of the head and neck.   "
209254|NCT00576199|"     This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab)     treatment combined with transarterial chemoembolisation (TACE) in patients with localized     unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4     sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously     was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE     sessions until disease progression.   "
209255|NCT00576212|"     This study focuses on women undergoing termination of pregnancy for fetal anomalies (TOPFA).     Psychological consequences of such terminations may be even greater than those associated     with spontaneous losses of pregnancy because of shame and guilt which can result in social     isolation. Currently, there is little support for women after they have left hospital. In     this study, 50 TOPFA women will be randomly assigned to an intervention group and 50 to a     control group. By completing four questionnaires at the time of induction of labour, total     sample will be assessed for depression, stress and hardiness; they will be reassessed at 3,     6, and 12 months. Total sample will be interviewed by phone at 6 and 12 months. We hope to     determine whether a telephone-based intervention (a biweekly supportive call) can decrease     the emotional distress experienced by women undergoing termination of pregnancy.   "
209256|NCT00576225|"     This study is designed to test whether CT-2103/carboplatin provides improved overall survival     compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels >30 pg/ml.   "
228057|NCT00837525|"     The purpose of this study is to determine if an implant material can be injected to repair     nasal valve collapse.   "
209261|NCT00576303|"     This single arm study will assess the efficacy, safety and tolerability of monthly     intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with     chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive     monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360     micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the     week preceding study start. The anticipated time on study treatment is 3-12 months, and the     target sample size is 100-500 individuals.   "
209262|NCT00576316|"     The purpose of the study is to evaluate the satisfaction level of patients using the     Symbicort SMART approach for their asthma management.   "
209263|NCT00576329|"     To determine whether use of topical 0.4% ketorolac has any effect on pupil size during     vitreoretinal surgery.   "
209264|NCT00576342|"     In this randomized crossover study, patients will receive a single drop of two test articles     and assess comfort.   "
209265|NCT00576355|"     This study will evaluate the effectiveness of interpersonal and social rhythm therapy in     treating adolescents with a bipolar spectrum disorder   "
209266|NCT00576368|"     The objective of this survey on this registered product is to confirm the efficacy, and     safety profile of Lantus in every day medical practice. This program will also help to obtain     information about the use of the insulin titration regimen and handling of the Lantus insulin     analogue.   "
209267|NCT00576381|"     The purpose of this study is to determine what happens to dexmedetomidine in the body after     it has been given to a newborn after heart surgery. We want to learn how long the drug stays     in the body, how the drug is metabolized by the body, and how well the medicine works at a     particular dose or amount.   "
209268|NCT00576394|"     entGlycemic control has been found to improve clinical outcomes following Coronary Bypass     Surgery. This study tests the hypothesis that obtaining tighter glycemic control(80-120mg/dl)     as opposed to more moderate control (120-180mg/dl) will further improve outcomes.   "
209269|NCT00576407|"     The study purpose is to determine whether thymus transplantation without immunosuppression is     effective in treating typical complete DiGeorge syndrome.   "
209270|NCT00576420|"     The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor     Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D     500 s-apr) for hemostasis in participants receiving prosthetic expanded     polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual     compression with surgical gauze pads.   "
209271|NCT00576433|"     This single arm study will evaluate the safety and efficacy of MabThera in patients with     active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an     inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg     i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a     clinically relevant response to the first course of treatment may be eligible to receive one     re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study     treatment is 3-12 months, and the target sample size is 100 individuals.   "
209283|NCT00581984|"     This study will collect 5 year data about any possible health problems associated with breast     implants. This data will be used to help see if the implants are both safe and effective. If     they are proven safe and effective, they will continue to be available. If they are not     proven safe and effective to the satisfaction of the FDA, they may not be available in the     future.   "
209284|NCT00581997|"     This study will evaluate the safety, tolerability, and mechanism of action of multiple doses     of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis   "
221958|NCT00758407|"     The purpose of this randomized controlled clinical trial is to investigate the efficacy and     safety of methylphenidate in patients with fatigue caused by cancer.   "
209272|NCT00576446|"     Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis     carries with it a median survival of approximately 12 months, with 90 - 95% of patients     surviving less than 2 years. The current standard treatment of surgical resection followed by     radiation therapy and chemotherapy has not substantially prolonged survival and even the few     treatment options shown to exhibit small increases in survival primarily benefit certain     (i.e., young) patient subpopulations.      Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body     to recognize the tumor cells as foreign and produce its own response to fight off recurring     tumor cells. A promising means of causing an immune response so the body can create this     immunity is through the use of dendritic cell (DC) vaccines.      Dendritic cells are a small group of cells contained in everyone's white blood cell     population. These cells are responsible for letting the immune system know that something     foreign, like bacteria, or a tumor, is in the body. Dendritic cells help the body ward off     disease by alerting the immune system.      gliadel is an FDA - approved drug - a wafer containing a concentrated amount of a     chemotherapy agent. These wafers are placed into the brain cavity after the tumor is resected     (removed) and deliver a steady amount of immediate chemotherapy medicine to the surrounding     brain tissue. Also, since Gliadel is a local chemotherapy, it will prevent the detrimental     suppression (weakening) of the immune system shown with systemic (throughout the body)     chemotherapy.      In prior Phase l and phase ll studies, patients who received chemotherapy following Dendritic     cells demonstrated longer progression free and overall survival than the patients who     received Dendritic cells or chemotherapy alone.      The purpose of this study is to determine whether after standard therapy of tumor resection     surgery, along with placement of Gliadel wafers at time of surgery followed by dendritic cell     vaccines will not only generate (start) an immune response, but will provide longer     progression free survival.      Patients who were screened and not enrolled in this clinical trial due to screen failure will     be notified of the reason for screen failure. Pre HIV counseling and appropriate referral     resources will be provided. If the screen failure is due to the positive HIV test,     appropriate post HIV counseling will be provided and appropriate referrals will be made. The     charts of the patients with screen failures will be destroyed.The patients charts who will be     enrolled in the study kept in the locked cabinet in the research office. patients will be     assigned a unique identifying code known only to the research team. Data will be captured by     various source documents, or, as necessary, abstracted from hospital medical records by an     experienced registered nurse. The electronic data for viral testing will be accessible to     research personnel only.   "
209273|NCT00576459|"     This is a 3-year randomized, dose masked, three-arm controlled, pilot study to evaluate the     safety and efficacy of the intravitreal FA implants (0.59mg and 2.1mg), when compared to     laser photocoagulation in the treatment of patients with diabetic macular edema.   "
209274|NCT00581867|"     To determine which parts of the brain are involved in insulin-related memory improvement in     early Alzheimer's disease and cognitively normal older adults.   "
209275|NCT00581880|"     The purpose of this study is to develop an accurate and useful way of measuring patients'     thoughts and feelings about hope and hopelessness as they relate to their illness. Doctors     and psychologists from Memorial Sloan-Kettering Cancer Center, Calvary Hospital, the Peter     MacCallum Cancer Centre, and Fordham University are working together to design a new measure.     Findings from this research will help us study the nature of illness and develop improved     methods of diagnosis and treatment. We hope what we learn from you will help us learn more     about how to care better for patients with cancer and other severe illnesses.   "
209276|NCT00581893|"     Automobile driving is a crucial aspect of everyday life, yet vehicular crashes represent a     serious public health problem. Patients with epilepsy are at elevated risk for automobile     crashes, causing great personal suffering and financial costs to society. Most collisions     involving epileptic drivers are not seizure related but may instead result from cognitive     effects upon driving performance of epilepsy and antiepileptic drugs (AEDs). Several million     American drivers take AEDs for treatment of medical conditions besides epilepsy and may also     be at risk for cognitive impairments that can reduce driving performance. Empirical evidence     of the effects of AEDs on driving performance would enable development of driving guidelines     that could lower the risk of injurious motor vehicle collisions; however, this evidence is     currently lacking. The broad goal of our project is to determine the specific effects of the     most commonly utilized AED, phenytoin, by assessing driving performance and cognitive     abilities in neurologically normal volunteers taking phenytoin in a randomized, double-blind,     placebo-controlled, crossover study. Our proposed experiments will assess: (1) cognitive     functions using standardized neuropsychological tests (of attention, perception, memory, and     executive functions), (2) driving performance during phenytoin and placebo administration,     and (3) the effects of phenytoin-related cognitive performance upon driving performance. To     measure driving performance, we will use a state-of-the-art fixed-base interactive driving     simulator that allows us to observe driver errors in an environment that is challenging yet     safe for the driver and tester, under conditions of optimal stimulus and response control.     The results of this study of 30 drivers treated with phenytoin and placebo will increase the     understanding of the role of AED-related cognitive impairment on driving safety errors. A     better understanding of the impact of AEDs upon driving performance is necessary to     rationally develop interventions that could help prevent crashes by drivers treated with     AEDs.   "
209277|NCT00581906|"     Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the     body using magnetic field and radio frequency pulses that can not be felt. Dynamic contrast     enhanced-magnetic resonance imaging (DCE-MRI) uses faster imaging and contrast material (a     substance used to make specific organs, blood vessels, or tumors easier to see) that is given     by vein. Diffusion weighted magnetic resonance imaging (DW-MRI) allows to measure the motion     of water around the cells in the tumor. Proton magnetic resonance spectroscopy (MRS) obtains     chemical information from the tumor. During MRS, signals are detected from the chemicals     (spectroscopy) naturally present in your tumor using radio waves. DCE-MRI, DW-MRI and MRS     give extra information which is not available with the regular MRI. The regular MRI only     shows pictures of the tumor while the DCE-MRI also gives information about the blood vessels     of the tumor. DW-MRI provides information related to the state of the tumor tissue with     regards to the quality or condition of cells present in it and MRS gives information about     the chemical makeup of the tumor.      The purpose of this study is to see whether DCE-MRI, DW-MRI and MRS done before treatment can     predict which patients will do well with either surgery or chemo-radiation therapy. This     study will also see if DCE-MRI, DW-MRI and MRS done early in treatment can tell if the     therapy is working.   "
209278|NCT00581919|"     Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of     4 to 8 times (based on response to the treatment). Patients will also receive     acetyl-L-carnitine (ALCAR) daily.   "
209279|NCT00581932|"     This is a study designed to identify genetic polymorphisms (also called allelic variants or     genetic markers) that are associated with response to clozapine. This information will be     used to enhance the understanding of clozapine response and side effects. DNA from patients     will be examined for significant associations between allelic variants in candidate genes in     relation to clozapine effects on positive and negative symptoms, global response, quality of     life, relapse rates and side effects.   "
209280|NCT00581945|"     Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab     (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function     in patients with COPD   "
209281|NCT00581958|"     The purpose of this study is to develop blood tests and urine tests that can tell doctors how     much radiation a person has been exposed to. Doctors know how much radiation patients are     exposed to in certain medical situations. An example of this would be radiation treatment for     cancer. Radiation treatment machines are programmed to give exact doses of radiation.   "
222062|NCT00759811|"     The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity     in patients with symptomatic ischemic heart failure.   "
209285|NCT00582010|"     This blinded, placebo-controlled study will administer inhaled nitric oxide to patients     undergoing liver transplantation. The purpose of the study is to test if inhaled nitric oxide     prevents liver injury associated with the restoration of blood flow. The premise of the     current study is provided by previous studies which document a protective effect of inhaled     nitric oxide in this clinical setting.   "
209286|NCT00582023|"     The purpose of this study is to examine the role of emotion and mood in the context of HIV.   "
209287|NCT00582036|"     To determine whether intensive glucose control results in improved mortality and reduced     hospital stay length by performing a randomized trial of intensive glucose management (blood     glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose     management (goal 200 mg/dl)   "
209288|NCT00582049|"     The purpose of the research study is to learn more about the causes of retinoblastoma and to     identify possible risk factors in the parents of patients with retinoblastoma. This kind of     study is called an epidemiology study and is often done by interviewing people with and     without the disease. In the case of a childhood disease, the researchers ask about     experiences of the parents and children before the disease developed.   "
209289|NCT00582062|"     We are undertaking a study of patients with gastric or pancreatic cancer. A common place for     cancer to return after surgery for gastric or pancreatic cancer is the inside lining of the     abdomen, called peritoneal metastasis. At the time of surgery, washing the abdomen with a     mild salt solution may reveal free cancer cells in the abdomen which could develop into     peritoneal metastasis. Recently, surgeons here at Memorial Sloan-Kettering have found that     patients who have these cells develop peritoneal metastases and are better treated with     chemotherapy rather than surgery. Sometimes, though, these cells might be present but cannot     be found by using current techniques. We are trying to figure out a better way to find these     free cancer cells. This could improve our treatment of patients with gastric and pancreatic     cancer. We need negative control population to which we can compare the peritoneal washings     of these cancer patients.   "
209290|NCT00582075|"     The protocol is designed to determine the efficacy of temozolomide in preventing the     development of new brain metastases within the first year in patients undergoing stereotactic     radiation for newly diagnosed brain metastases.   "
209291|NCT00582088|"     The study is designed to assess the safety and immunogenicity of Venezuelan Equine     Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.   "
209292|NCT00582101|"     The proposed project will develop and test an HIV prevention intervention for Latino     families. This study will:        1. Conduct a pilot run-through of an adapted family-based intervention with three cohorts          (about 24 families) to determine the feasibility, acceptability, and appropriateness for          the target population.        2. Revise the family-based HIV prevention intervention based on the results of the pilot          run-through and structured exit interviews.        3. Recruit and randomize 100 families into the Latino family-based HIV prevention          intervention or a general health promotion condition.        4. Estimate the effect size of the Latino family-based HIV prevention intervention from          assessment of changes in HIV-related sexual behavior and attitudes and parental          monitoring/supervision over 6 months.      Based on a thorough review of the literature, the following is anticipated:        1. The revised intervention will be feasible, acceptable, and appropriate for Latino          families and will be enthusiastically received.        2. The family-based HIV prevention intervention will result in safer adolescent sexual          behavior, greater change with regard to primary outcome measures of behavior (recent          sexual activity, the number of unprotected sex acts, proportion of condom use, and          intentions to use condoms), safer HIV-related attitudes, improved parent-child          communication skills, and greater parental monitoring than the Latino families in the          general health promotion condition.   "
209293|NCT00582114|"     We will directly test the hypothesis that an initial strategy of lisinopril-based therapy     will be more effective than atenolol-based therapy in causing regression of left ventricular     hypertrophy (LVH) over one year in patients with hemodialysis hypertension despite similar     degree of BP reduction.   "
209294|NCT00582127|"     This study will evaluate a handheld event-related potential (ERP) testing device from     Neuronetrix, Inc. as a method to collect ERP data in an outpatient setting.      An ERP system records electrical signals at the scalp that are produced by the brain when     performing cognitive tasks. By doing this study, we hope to evaluate various performance     parameters of the COGNISION(TM) system.   "
209295|NCT00582140|"     The investigators are trying to find new methods to treat prostate cancer. The approach they     investigators are taking is to try to enhance patients own immune response against the     cancer. In this study the investigators will be testing the safety of a vaccine that may be     able to help the body fight prostate cancer.   "
209296|NCT00582166|"     Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab     consolidation and maintenance therapy every 3 months until disease progression   "
209297|NCT00582179|"     This project is designed as a prospective, randomized, comparative study evaluating the use     of a negative pressure vacuum device in treating draining hematomas following traumatic     injury.   "
209298|NCT00582192|"     The purpose of this study is to examine doctor-patient communication about treatment options     which may include an experimental, new treatment for cancer. What we learn from this study     may help us to teach doctors better ways to talk to their patients.   "
209299|NCT00582205|"     The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen     (belly) along with intravenous administration.   "
209300|NCT00582218|"     The purpose of this study is to find ways to get services to families living with HIV. New     services for families living with HIV have been tried in places around the country. They seem     to benefit many families. We will work with places in New York City that provide HIV services     to find out more about family services. There, we will talk with people living with HIV,     their family members, and their providers. Many questions need to be answered. For example:     What kinds of services do families want? What would make it easier for families to come in     for services? What would get in the way?   "
209674|NCT00596063|"     The purpose of this study is the comparative evaluation of the pharmacokinetics and     pharmacodynamics of two recombinant regular human insulin injections administered     subcutaneously in healthy volunteers under the conditions of euglycemic clamp.   "
209301|NCT00582231|"     The purpose of this study is to help us understand more about your experience with penile     injection therapy. Many men become anxious when thinking about penile injections. We would     like to understand more about this anxiety. You will be asked to fill out questionnaires     before you start penile injection training, at each training visit, and then at your four     month follow-up visit.   "
209302|NCT00582244|"     Background: Breast cancer is the most common form of cancer among women in the Netherlands.     Approximately 11,000 women are diagnosed with breast cancer annually, of whom about 30% are     below 50 years of age. Premenopausal women with breast cancer treated with chemotherapy or     hormonal therapy may experience a premature onset of the menopause. Estrogen deficiency     following adjuvant treatments leads to primary endocrine symptoms, including vasomotor and     urogenital problems. Secondary symptoms include insomnia due to night sweats, dyspareunia due     to vaginal dryness, weight gain, and psychological distress. The symptoms resulting from     accelerated estrogen withdrawal can be pronounced and severe, and may adversely affect     women's sexual functioning, body image, and overall HRQL. Healthy women who enter natural     menopause are often prescribed hormone replacement therapy (HRT) to alleviate vasomotor and     sexual symptoms. However, due to possible tumor-promoting effects, HRT is contraindicated for     patients with a history of breast cancer. For these women, non-hormonal medications are     frequently prescribed to treat vasomotor symptoms. Although these medications have been shown     to yield moderate symptom relief, they also have a number of bothersome side effects. To     alleviate urogenital symptoms, local vaginal moisturizing or estrogen cream is often     prescribed. There is growing evidence that cognitive behavioral therapy (CBT) including     relaxation techniques, and physical exercise may effectively reduce vasomotor symptoms in     naturally occurring menopause. CBT and relaxation techniques are aimed primarily at the     modification of precipitants of hot flushes and at stress management. Physical exercise on a     regular basis affects neurotransmitters, which regulate central thermoregulation.      Purpose: The proposed study will evaluate the efficacy of a supportive intervention program     in alleviating menopausal symptoms, improving sexual functioning and enhancing the quality of     life of younger women (< 50 years) with breast cancer who have become prematurely menopausal     as a result of their treatment. Specifically, the study will evaluate CBT including     relaxation (A), physical exercise (B), and a combination of A and B.      Plan of investigation: This multicenter study will employ a prospective, full-factorial     design. In total, 325 consenting women will be randomized to group A, group B, group AB or a     usual care, 'waiting list' control group (N = 81-81 per group). Upon completion of the study,     the patients assigned to the control group will be given the opportunity to undergo either     the A or B intervention program. The program will begin with a structured assessment of the     target symptoms: hot flushes, night sweating and vaginal dryness. The overriding goal of the     intervention is to provide symptomatic women with information skills and support to manage     their symptoms more effectively. For group A, the intervention will consist of 6 weekly group     CBT sessions of 1.5 hours, of 15 minutes of daily homework and a booster session at 3 months.     The CBT will focus on understanding and self-control of menopausal symptoms. Relaxation     techniques (paced respiration and muscle relaxation) will focus on the reduction of     sympathetic nervous system activity, and are expected to have a positive impact on the     frequency and intensity of hot flushes. For group B, the intervention will be an individually     tailored, 12 week home-based physical exercise program of 2.5-3 hours per week, with     instructions provided in-clinic on 2 occasions, and telephone support on 2 additional,     interim occasions. The physical exercise program is intended to enhance fitness levels, in     general, and to improve thermoregulation specifically related to hot flushes. Group AB will     receive both the CBT and exercise program elements. Women allocated to the intervention     groups will be asked to complete a battery of questionnaires assessing menopausal symptoms     (the primary outcome), sexuality, body- and self-image, psychological distress and generic     HRQL prior to the start of the program (baseline, T0), at 12 weeks (T1) and at 6 months     follow-up (T2). Women allocated to the control group will complete the same questionnaire     battery at parallel points in time.      Results/ relevance: If demonstrated to be effective, the availability of a structured     supportive intervention program (modules A, B or AB) will be a welcome addition to regular     medical care offered to breast cancer patients with treatment-induced menopause. It is     anticipated that such a program will have direct benefit in terms of symptoms relief and the     improvement of patients' HRQL.   "
209303|NCT00582257|"     The purpose of this study is to establish a gastric cancer registry. A registry is a database     of information. With the registry, we can learn more about the genetic causes of gastric     cancer in order to develop better methods of early diagnosis, prevention, and treatment of     gastric cancers. As part of this study, you will be asked to join a registry of families who     are affected with various forms of gastric cancer. These registries are important because     they may help physicians better manage gastric cancer now and in the future. Participating in     the Early Onset and Familial Gastric Cancer Registry can also be educational for families,     since it will provide important information to patients, families, and physicians. All of     this will help to further our understanding of genetic causes of gastric cancer and     eventually, help determine better ways to diagnose, treat, and survey patients with gastric     cancer and people who may have a higher risk for gastric cancer.   "
209304|NCT00582270|"     The purpose of this study is to determine if an infectious disease may be associated with the     new lymphoma diagnosis.      Infections to be tested include:        1. Helicobacter pylori (H. pylori): This is a bacteria sometimes found in the stomach that          has been associated with a particular kind of lymphoma, gastric MALT. We are interested          to learn if the H. pylori infection may be associated with other indolent lymphomas.        2. Hepatitis C: This virus infection of the liver has been found in association with          non-follicular lymphomas in Italy. We want to determine if the infection is associated          with lymphomas in the United States.        3. Bacterial overgrowth of the small bowel: Since indolent lymphomas often affect the lymph          nodes surrounding the small bowel, it may be possible that an infection within the bowel          is stimulating lymphoma growth. This has never been demonstrated to date, and will be          studied in this clinical study.        4. Epstein-Barr virus: This is the virus that causes infectious mononucleosis or mono. It          has been associated with other rapidly growing lymphomas, but not indolent lymphoma.   "
210952|NCT00613808|"     The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the     treatment of venous ulcers of the lower leg.   "
209305|NCT00582283|"     This study seeks to determine imaging characteristics of radiolabelled 131-I-NM404 in ten     patients with cancer, including calculations of PKs, radiation dosimetry, biodistribution,     and optimal imaging times (part 1 - complete).      In addition, specific tumor accumulation and metabolic fate of 131-I-NM404 will be determined     in NSCLC tumors collected in 5 patients (part 2 - complete). Lastly, the study will collect     preliminary data on imaging NSCLC tumors in up to 12 patients with evaluable disease (part 3     - ongoing).   "
209306|NCT00582296|"     The purpose of this study is to examine how people with a family history of colon cancer and     other related cancers respond to recommendations for cancer screening after genetic     counseling. The purpose of your participation would be to help us learn more about whether     people with a personal and/or family history of colorectal cancer and other cancers follow     cancer screening recommendations.   "
209307|NCT00582309|"     Increasing evidence from observational studies in hospitalized patients with and without     diabetes indicates that hyperglycemia is a predictor of poor outcome. Over the short-term,     hyperglycemia can adversely affects fluid balance (through glycosuria and dehydration),     impairs immunologic response to infection, and promotes inflammation and endothelial     dysfunction. Blood glucose control with intensive insulin therapy in patients with acute     critical illness reduces the risk of multiorgan failure and systemic infections, and     decreases short- and long-term mortality .      - Hypotheses: we hypothesize that management of inpatient hyperglycemia with a     computer-guided intravenous infusion protocol (Glucommander) will facilitate a smoother     glycemic control with a lower rate of hypoglycemic events than treatment following a standard     insulin infusion algorithm or a simple calculated infusion protocol in critically ill     patients in the medical and surgical ICU.   "
209308|NCT00582322|"     The purpose of this study is to determine the specific genetic alterations associated with     breast cancer. This will leat to a better understanding of the genetic causes of breast     cancer.   "
209309|NCT00582335|"     The purpose of this study is to define new genes for family risks of developing colon cancer.   "
209310|NCT00582348|"     The purpose of this study is to learn how often lung cancer survivors exercise. We also want     to learn what helps people to be active or prevents them from being active. Learning this     will help us to expand services for lung cancer survivors.   "
209311|NCT00582361|"     This project is designed as a prospective, randomized, comparative study evaluating the use     of a negative pressure vacuum device in treating traumatic wounds sustained associated with     an open fracture.   "
209312|NCT00582374|"     To determine the relationship between periodontal disease and upper genital tract     inflammation in pregnancy. To determine whether certain fluid levels in the oral cavity and     the vagina are associated with preterm birth or low-birth weight.   "
209313|NCT00582387|"     The purpose of the study is to see if we will be more able to tell what the risk is for     bladder cancer to reoccur or worsen when genetics and risk factors are examined along with     the stage and grade of the tumor. Superficial bladder cancer is a cancer that does not grow     into the muscle layer of the bladder wall. Even though it is a superficial cancer, this type     of cancer tends to come back after being treated and is often more aggressive when it     returns. We already know, that the stage or how deeply the tumor grows into the bladder     wall and the grade or how fast the tumor grows affect whether the tumor will come back or     get worse over time. Now we use information about the stage and grade of your tumor to decide     how to treat the tumor and how often you should be checked after the treatment is over.     However, this has not been very reliable, because each person has unique genetic     characteristics and other factors that are likely to affect what happens to the tumor over     time. For instance, we know the risk for developing a cancer may be affected by your     surroundings and other factors such as what you eat, the type of habits you have such as     smoking, and the type of job you have, but not everyone exposed to the same risk factors gets     a cancer. We believe this is due to unique genetic characteristics in each person which may     help their body fight cancer.   "
209314|NCT00582400|"     The purpose of this study is: evaluate the safety and activity of administering arsenic     trioxide (Trisenox) in the treatment of unresectable or metastatic primary liver cancer, to     evaluate the qualitative and quantitative toxicities of this treatment, and to measure the     response to treatment and the patterns of failure and survival. The primary response     measurements will be the achievement of an objective tumor response, response duration and     progression-free survival   "
209315|NCT00582413|"     The purpose of this study is to learn more about the quality of life and emotional changes     that patients experience during their treatment for cancer of the mouth. We want to learn     more about the emotional and quality of life problems that occur during and after treatment.     This will help us better understand these complex issues and improve treatment.   "
209316|NCT00582426|"     This study will evaluate the efficacy of Octreotide LAR in preventing chemotherapy-induced     diarrhea (with regimens that contain 5 fluorouracil, irinotecan and capecitabine)in patients     with colorectal cancer.   "
209317|NCT00582439|"     This study is to determine the composition of bone graft harvested using the RIA system in 16     orthopaedic trauma patients between age 19 and 65 who have sustained a fracture or non-union     requiring bone grafting. The patients will be followed to assess clinical outcomes and     associated pain.   "
209318|NCT00582452|"     The purpose of this study is to learn more about individual's with a family history of colon     cancer and the process by which they may decide to undergo or not undergo prophylactic     colectomy. This is a surgery to remove the colon in order to reduce risk of cancer (or of     getting cancer again).   "
209319|NCT00582465|"     This is a study to determine if people with Lupus have weak bones.      Test which is a better method for detecting bone changes:        -  Dual energy X-ray absorptiometry (DXA)        -  Single energy quantitative computed tomography (SEQCT)      Evaluate whether weak bones are associated with things like medications or amount of fat and     muscle.   "
209320|NCT00582478|"     The purpose of this study is to look at how breast cancer treatment affects quality of life     in women of different ages. The U.S. Army Breast Cancer Research Program funds this study. In     this research project, we wish to study a woman's quality of life after breast cancer     treatment as related to her health. We want to know how you feel about your quality of life.   "
230927|NCT00869284|"     Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3     untreated aggressive NHL.   "
209321|NCT00589472|"     This phase II trial studies how well androgen deprivation therapy and vorinostat followed by     radical prostatectomy works in treating patients with prostate cancer that has not spread to     other parts of the body. Androgens can cause the growth of prostate cancer cells. Antihormone     therapy, such as bicalutamide, goserelin acetate, and leuprolide acetate, may lessen the     amount of androgens made by the body. Vorinostat may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Giving androgen deprivation therapy and     vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed.   "
209322|NCT00589485|"     The purpose of this study is to collect radiographic and clinical outcomes of total knee     replacement using Simplex® or Cobalt™ Bone Cement.   "
209323|NCT00589498|"     Understanding the mechanisms of obesity-induced hypertension is important both for prevention     and therapy. Studies of patients with established obesity have provided valuable information     on pathophysiologic links between obesity and both blood pressure and cardiovascular risk.     However, these studies are necessarily limited by the heterogeneity of obesity-associated     disease so that the relative contribution of obesity or hypertension or other co-existing     diseases to specific regulatory abnormalities is often not clear. Clarification of whether     any abnormalities associated with increased cardiovascular risk were present before or after     the development of obesity has also been problematic.      We therefore propose a series of novel studies directed at establishing the effects of     increased body fat in otherwise healthy individuals. We will determine the distribution     patterns of increased body fat and how both increased body fat and fat distribution relate to     changes in blood pressure, and in neural, endothelial and inflammatory mechanisms which have     been implicated in the development and progression of cardiac and vascular disease.      We will study non-obese subjects with and without a family history of hypertension. These     subjects will undergo an eight-week program of overfeeding with the objective of inducing a 4     kg fat gain. We will determine the nature of fat distribution in these individuals after the     fat gain program and subsequently after an eight-week period of weight loss and restoration     of normal body weight. Measurements will be compared to those obtained in a matched control     group with and without a family history of hypertension, who will continue their normal     diets. We will test the following hypotheses:        -  Individuals with a family history of hypertension will gain more visceral fat and upper          body subcutaneous fat and will have greater blood pressure increases with overfeeding-          compared with those without such a family history.        -  For all overfed subjects, increases in blood pressure and insulin resistance with fat          gain will be most marked in those individuals with a predominantly upper body and          visceral fat accumulation.        -  Upper body and visceral fat gain will also be associated with greater impairment in          cardiovascular function, higher nocturnal blood pressures and an increased likelihood of          sleep disordered breathing.   "
209324|NCT00589511|"     The objective of this multisite study is to evaluate the performance of the Nucleus Freedom     cochlear implant system in a large population of sequentially implanted pediatric subjects.   "
209325|NCT00589524|"     To compare results of Intravascular Ultrasound (which occurs during cardiac catheterization)     with Computed Tomography (CT) scan to detect blockages or narrowing of the arteries that feed     the heart. These will be studied in the cardiac transplant population.   "
209326|NCT00589537|"     RATIONALE: Imaging procedures, such as MRI and CT scan, may find recurrent cancer. It is not     yet known which MRI or CT scan schedule is more effective in finding recurrent cancer.      PURPOSE: This randomized phase III trial is comparing four different MRI and CT scan     schedules in patients with stage I seminoma of the testicle.   "
209327|NCT00589550|"     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may     also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving     PEG-interferon alfa-2b together with sorafenib may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon     alfa-2b and sorafenib in treating patients with unresectable or metastatic kidney cancer.   "
209328|NCT00589563|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood     stem cell transplant helps stop the growth of cancer cells. It also stops the patient's     immune system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor     effect). Sometimes the transplanted cells from a donor can also make an immune response     against the body's normal cells. Giving tacrolimus, sirolimus, antithymocyte globulin, and     methotrexate before and after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well sirolimus, tacrolimus, and antithymocyte     globulin work in preventing graft-versus-host disease in patients undergoing a donor stem     cell transplant for hematological cancer .   "
209329|NCT00589589|"     This study is intended to fill the knowledge gap regarding the burn population with research     that achieves scientific merit. we will determine the effectiveness of the computer decision     support system (CDSS) to facilitate glucose management in the critically ill burn patient.      The EndoTool™ computer decision support system will achieve glycemic control (defined as     80-110 mg/dL) in a shorter time, reduce glycemic excursion outside of target range, and     reduce incidence of hypoglycemia (blood glucose less than 50 mg/dL) in the critically ill     burn patient compared to the standard of care USAISR insulin titration protocol (Appendix A).   "
209330|NCT00589602|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood     stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the     patient's immune system from rejecting the donor's stem cells. When stem cells from a donor     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor     can make an immune response against the body's normal cells. Removing the T cells from the     donor cells before transplant may stop this from happening. Giving an infusion of the donor's     T cells (donor lymphocyte infusion) after the transplant may help destroy any remaining     cancer cells (graft-versus-tumor effect).      PURPOSE: This phase II trial is studying T-cell depletion in donor stem cell transplant     followed by delayed T cell infusions in treating patients with hematologic cancer or other     disease.   "
209331|NCT00589615|"     The study will elucidate the effectiveness of an educational program in the prevention of     osteoporosis and fractures. A random sample of the female population in Southern Finland     (Uusimaa region) within the age group of 60-70 years was drawn from the population registry.     From 1996 through 2000, 2181 women from the population register were recruited and randomly     assigned to the intervention and to the control group. The subjects in the intervention group     have been on a multidisciplinary program and the subjects in the control group received     osteoporosis prevention information through the media and health care system. An end point is     any fracture during the ten-year follow-up.   "
209332|NCT00589628|"     The primary objective of this study is to examine the efficacy of infliximab for the     treatment of persistent uveitis in children. Participants (4-18 years of age) will be     randomly assigned to either 5mg/kg or 10mg/kg dose of infliximab to be administered by     intravenous infusion at four week intervals. Participant responses will be measured at at     four to eight week intervals for up to ten months.   "
209333|NCT00589641|"     The purpose of this study is to develop, refine, and pilot test an augmenting cognitive     behavior relapse prevention intervention (CBT-RP) for suicidal, depressed, and     alcohol/substance abusing adolescents. No hypotheses are being tested, but it is expected     that CBT-RP in addition to treatment as usual will result in improved outcomes relative to     treatment as usual alone.   "
209334|NCT00589654|"     Very little is known about the incidence, onset, time course, and symptomatology of premature     menopause induced by breast cancer therapy. No prospective study exists. The purpose of the     present study is to identify determinants of treatment-related amenorrhea nad its effect on     quality of life in a cohort of youg breast cancer patients.   "
209335|NCT00589667|"     The purpose of this study is to determine if the combination of 2 chemotherapy drugs called     pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell     cancer. The researchers want to find out what effects, good and/or bad, that this treatment     has on head and neck cancer.   "
209336|NCT00589680|"     At this time, Saint Mary's Medical Center is currently in the process of implementing a     standardized diabetic ketoacidosis (DKA) protocol. The first main goal of this project will     be to evaluate patient outcomes to determine the effects of treating patients without a     standardized protocol and to establish a baseline on how patients are being treating with     DKA. The final goal of the project will be to compare outcomes of those patients not placed     on the protocol to those that were treated using SMMC newly implemented DKA protocol. The     overall goal of this project is to determine the benefit of an institutional DKA protocol.   "
209337|NCT00589693|"     The purpose of this study is to show that doripenem is as effective as imipenem-cilastatin in     the treatment of patients with ventilator-associated pneumonia.   "
209338|NCT00589706|"     Data from the wistar institute indicated that this anti-body labeled with iodine-125 would     localized in the tumor cells of high grade gliomas of the brain. the project combines     surgery, radiation therapy, chemotherapy with the labeled antibody in a prospective phase II     trial in this disease entity.   "
209339|NCT00589719|"     The purpose of the study is to conduct a cross-sectional study to examine asthma prevalence     and morbidity in a predominately minority, low-income population in rural Arkansas.   "
209340|NCT00589732|"     To evaluate that angiotensin-converting enzyme (ACE) inhibitors and angiotensin-converting     enzyme receptor blockers (ARBs) reduce the risk of restenosis after DES implantation.   "
209341|NCT00589745|"     The purpose of this research study is to provide a novel method for the diagnosis of Cystic     Fibrosis (CF). This protocol is designed to test the ability of the cells to regulate the     movement of salt and water in people with features of CF in whom the diagnosis is not     entirely clear. We will be studying these cells in the nose, by a technique called nasal     transepithelial potential difference (NPD).   "
209342|NCT00589758|"     The primary purpose of this study is to learn if taking pictures of your heart using two     dimensional and three dimensional echocardiography in the heart failure intensive care unit     can be helpful to understanding how the heart is working.      All research subjects will be adults admitted to the heart failure ICU with acute     decompensated heart failure and requiring monitoring of their heart function using a catheter     that is placed in the pulmonary artery which is a blood vessel. In this situation, use of the     pulmonary artery catheter,or PAC, is considered standard clinical care. It is not a research     procedure. The PAC would be used even if you were not participating in this research project.      All research subjects will be evaluated at the time they are admitted to the ICU, 24 to 48     hours after admission to the ICU, and 7 days after leaving the ICU. At all three time points,     we will be taking pictures of the heart using the two dimensional and three dimensional     echocardiogram.      Additionally, at each time-point, we will collect a blood sample of approximately two and a     half tablespoons each time, and a urine sample. We will be testing the sample for biomarkers     of heart failure which are proteins and enzymes specifically related to heart function. We     will not be conducting any genetic research on the sample. Any extra blood from these     research tests will not be saved for future research.      We will also be looking at the data that is collected by the pulmonary artery catheter. The     catheter has a sensor on it that measures things like blood flow and pressure in the heart.      At the Day 7 post discharge visit there will be a six minute hall walk so that we can access     the distance that you can walk. We will access any symptoms that you may experience. A nurse     or physician will monitor the six minute hall walk.      The research information that we collect on you will not be placed in your medical record.     The data is for research purposes only.   "
209343|NCT00589771|"     Various studies have been conducted in past using different strains of probiotics in     evaluating IBS symptoms. The results are by no means consistent and the overall impact of     probiotics in IBS remains unclear. However, recently O'Mahony L et al have shown that     Bifidobacterium infantis 35624 alleviates symptoms in IBS; this symptomatic response was     associated with normalization of the ratio of an anti-inflammatory to a proinflammatory     cytokine (IL-10/IL-12 ratio), suggesting an immune-modulating role for this organism, in this     disorder.Saccharomyces boulardii is a probiotic yeast that has been successfully used for the     antibiotic induced diarrhea, prevent relapse of Clostridium difficile and Crohn's disease. It     ameliorates intestinal injury and inflammation caused by a wide variety of enteric     pathogens.We therefore plan a Double-blind, randomized, placebo-controlled study to assess     the effects of Saccharomyces boulardii in improving symptomatology of diarrhea predominant     IBS and its effect on quality of life. We also plan to assess the changes in the relative     production of anti-inflammatory interleukin (IL)-10 to proinflammatory cytokines (IL-12, IL-8     and TNFα).   "
209344|NCT00589784|"     The purpose of this study is to find out what effects, good and/or bad, sunitinib has on     patients and their tumors. At this time, no drugs are routinely used to treat meningioma,     hemangioblastoma or hemangiopericytoma. Only surgery and radiation therapy are known to be     useful.      Sunitinib is a drug approved for advanced kidney cancer. Sunitinib is also being studied for     other tumors. It may be useful in the treatment of brain tumors because it can prevent     formation of new blood vessels that allow tumor cells to survive and grow.   "
209345|NCT00589797|"     The purpose of this study is to learn whether an investigational device called the Activ-L     Artificial Disc is safe and effective in the treatment of degenerative disc disease of the     lower (lumbar) spine.   "
209346|NCT00589810|"     In this replication study at the Cleveland Clinic, we seek to collaborate to validate     findings of the CardioGene Study in an independent cohort of patients who have undergone bare     metallic stenting.   "
209347|NCT00593242|"     This is a pilot study to test feasibility of collection, preparation and infusion of a baby's     own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born     with signs of brain injury.   "
209348|NCT00593255|"     This trial is conducted in Asia. The aim of this trial is to compare the efficacy of     postprandial plasma glucose of two treatment regimens in Chinese subjects.   "
230928|NCT00869297|"     Fluid management of surgical patients has changed dramatically in recent years. Recent     studies have shown that so called 'restrictive' fluid strategies can improve outcomes such as     length of stay and time to fitness for discharge. Furthermore, new monitoring technologies     have been developed that allow the clinician to better monitor the effects of intravenous     fluid therapy.      The fluid management of free flap reconstruction surgery is controversial. As vasoactive     agent use during the anesthetic is not the preferred intervention for the treatment of     hypotension, fluid therapy is often administered to correct hemodynamic instability. A     liberal fluid strategy may predispose the flap to edema, venous congestion and ultimately     flap failure. A restrictive fluid strategy however has (at this institution) anecdotally been     reported to lead to a higher incidence of deep venous thrombosis (DVT) and pulmonary embolus     (PE). Thus, there is clinical equipoise as to the optimal fluid management for these     patients.      Non-invasive cardiac output (CO) monitoring based on the arterial pulse contour is a nascent     technological advance that has been widely validated in the operating theatre. The     calculation of CO is based on the assumption that stroke volume is proportional to the     integral of the area under the arterial pressure versus time curve. With these monitors, the     variation in stroke volume during mechanical ventilation is also calculated and this can be     utilized as an estimate of the patient's volume status. A stroke volume variation (SVV) of     less than 15% has been shown to be indicative that a patient is no longer volume responsive.      In our study, we plan to recruit patients undergoing microvascular free flap reconstruction.     Patients will be randomized to either standard care, or goal directed fluid therapy.      All patients will receive a pre-operative 5 ml kg-1 bolus of normal saline. Subsequently, all     patients will then receive lactated ringers at a rate of 5 ml kg-1 hr-1. Patients in the     intervention group will have their CO and SVV monitored by a Flo-Trac pulse contour monitor     (Edwards Life Sciences, Irvine, CA). Patients in the intervention group will receive 6%     tetrastarch boluses (Voluven, Fresenius Kabi, Hamburg, Germany) if their SVV exceeds 15%.     Patients in the control arm will receive fluid at a rate and type at the discretion of the     attending anesthesiologist to maintain hemodynamic stability and a urine output of 0.5 ml     kg-1 hr-1.      Intra-operative variables studied will include total fluid administered (colloid and     crystalloid), urine output, SVV and CO (both at the start and end of surgery). Postoperative     variables examined will be urine output, daily fluid balance (days 0-3), incidence of DVT,     PE, pulmonary edema, rate of re-operation, daily serum creatinine, chloride and bicarbonate     concentration, and incidence of flap failure.      Measurements of flap oxygenation and water content will be made with near infrared     spectroscopy at baseline, and during the immediate post-operative period (days 1-7).      We hypothesize that the goal directed group would have more intra-operative colloid given     with a reduced incidence of adverse outcomes.   "
209349|NCT00593268|"     In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt     Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain     aneurysm. We then propose to study the cerebrospinal fluid using a novel microscopic laser     directed mass spectrometric analysis (MALDI) available at Vanderbilt. The cerebrospinal fluid     and blood will then be analysed for different biological markers, protein expression and gene     expression. These markers will then be statistically correlated with clinical data including     prediction of vasospasm, time to vasospasm and response to standard therapy.   "
209350|NCT00593281|"     Double-blind study comparing the pharmacokinetics, safety and tolerability of morphine     administered subcutaneously (SC) with and without human recombinant hyaluronidase (HYLENEX)     and intravenously conducted in patients in a hospice care setting or through a palliative     care medicine setting. In this within-patient controlled study, each eligible study patient     receives a single injection by each of the three methods of morphine administration,     sequentially on three consecutive days, according to the order specified by a randomization     schedule.      Each of the three injections consists of 5 mg of morphine (1.0 mL of 5 mg/mL solution). The     HYLENEX injection will be 1 mL of 150 units. Although the IV administration will not be     blinded, the two SC injections will be double-blinded, using the same volume of normal saline     (0.9% sodium chloride) placebo (1.0 mL) as HYLENEX.   "
209351|NCT00593294|"     Oral contraceptive therapy is routinely used for the treatment of menstrual disturbances of     patients with polycystic ovary syndrome (PCOS).      To date, the cardiovascular risk (CVR) of the oral contraceptives (OC) are known but no data     are available on the CVR in PCOS patients treated with OC or physical exercise.      The purpose of this study is to compare the effects of OC to physical exercise on the CVR of     PCOS women and show the hormonal and metabolic effects of these two different treatment.      We hypothesize that physical exercise has the same beneficial effects of OC therapy on     hormonal and metabolic features of PCOS women with less cardiovascular consequences.   "
209352|NCT00593307|"     The overall objective is to investigate the effects of low and high glycemic index (GI) meals     varying in protein content on plasma glucose and insulin response, subjective ratings of     hunger, and subsequent food intake in twenty healthy, sedentary, overweight and obese men and     women between the ages of 21-65.   "
209353|NCT00593320|"     This study will evaluate the most effective radiation dose. Patients will be randomized (like     flipping a coin) to receive either low dose stereotactic radiotherapy (defined as 14 Gy) or     high dose stereotactic radiotherapy (defined as 18 Gy).   "
209354|NCT00593333|"     This project is designed to determine whether or not the trochanteric insertion portal will     show any difference when compared with the piriformis fossa portal in terms of pain and     strength of the hip abductor muscles, while allowing faster surgical fixation of the femur     fracture.   "
209355|NCT00593346|"     Over the past two decades, breast conserving therapy (BCT) has become a major treatment     modality for Stage I and II breast carcinoma. The major advantages of breast conserving     therapy are superior cosmetic outcome and the reduced emotional and psychological trauma     afforded by this procedure compared with conventional mastectomy. The principal disadvantage     of BCT is its more complex and prolonged treatment regimen requiring approximately 6 weeks of     external beam radiation therapy that poses problems for some patients such as the working     woman, elderly patients, and those who live at a significant distance from a treatment     center. These factors, along with the patient's geographic location, result in a smaller     fraction of the patients who currently meet eligibility criteria for BCT actually receiving     it, despite its cosmetic and probable psychological advantages. The logistical problems of     BCT are primarily related to the protracted course of external beam radiation therapy to the     whole breast. While some investigators reported what they believe to be acceptable local     control rates in carefully selected patients treated by wide local excision without radiation     therapy, the criteria for patient selection are controversial and poorly defined and probably     restrict the access of many patients to breast conserving therapy.      If previous observations are valid and breast irradiation following tylectomy exerts its     maximal effect in eradicating occult disease remaining in the immediate vicinity of the     tylectomy site, can radiation therapy be directed only to the tissue surrounding the excision     cavity of the breast, using brachytherapy alone? If so, the entire course of radiation     therapy could be delivered over a 4 to 7 day period immediately following tylectomy and/or     axillary dissection, thus markedly reducing treatment time. Brachytherapy also inherently     provides a higher central dose to the volume most at risk for recurrence. Cosmetic outcome     after the use of a brachytherapy boost after external whole breast radiotherapy is comparable     or slightly inferior to electron beam boost radiation therapy   "
209356|NCT00593359|"     This study will compare the effect of two intravenous solutions on eye pressure during spine     surgery in the following groups:      Group A - Lactated Ringer's replacement for blood loss and placebo eye drops      Group B - Lactated Ringer's replacement for blood loss and brimonidine eye drops      Group C - Albumin replacement for blood loss and placebo eye drops      Group D - Albumin replacement for blood loss and brimonidine eye drops   "
209357|NCT00593372|"     The purpose of this study is to collect data on the effects of behavioral interventions for     memory and communication deficits in persons taking cholinesterase inhibitors compared with     the effects of cholinesterase inhibitors alone. Initial testing will include a written case     history, tests of communication skills, and interviews with the participants, family, and     staff caregivers to help select potential goals for treatment. Participants will be randomly     selected to participate in Group A (control) or Group B (intervention). Group A will use a     Caregiver Checklist for eight weeks to identify any increase or decrease in the occurrence of     the identified communication deficits. Group B will have 16 treatment sessions by a Speech     Language Pathologist during the eight-week period. A post test will be administered to all     participants.   "
209358|NCT00593385|"     Prospective, multicenter, non-randomized, single-arm registry to evaluate the safety and     effectiveness of the iCAST Covered Stent System in the treatment of patients with symptomatic     claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in     the common and/or external iliac artery.   "
209359|NCT00593398|"     Malaria is caused by a parasite and is a health problem for mothers and fetuses (unborn     infants). The Cameroonian Ministry of Health recommends that all pregnant women should take     the drug sulfadoxine-pyrimethamine (also known as SP) every two months during pregnancy to     avoid malaria. The purpose of this study is to find out how effective SP is in preventing     pregnant Cameroonian women from getting malaria. Additional goals of this study are to see     whether: SP prevents malaria parasites from causing changes in the placenta; SP prevents or     helps women make a substance that keeps parasites from accumulating in the placenta; and     whether SP affects the amount of protection a mother transfers to her baby. Participants will     include 1,160 pregnant women, ages 15-50 years, and 216 babies born residing in Ngalii II and     Ntouessong. Study procedures will include monthly blood samples from pregnant women and     babies. Volunteers may participate in this study for up to 19 months.   "
209360|NCT00593411|"     The collection of data from the myriad of services described is significantly impacted by NIH     guidelines defining medical research involving humans as well as the recent implementation of     HIPAA constraints which further complicate the conduct of retrospective clinical outcomes     research. Simple case reports or case series analysis now involve IRB participation as well     as voluminous documentation.      The solution to this dilemma lies in developing and promoting secure, confidential     prospective clinical databases for storing clinical data for subsequent retrospective     de-identified inquiry. These databases function in a way analogous to tissue banks for     subsequent basic science research. Patients consent to prospective entry of their clinical     information into the database so long as they continue to be a patient with the Department of     Neurological Surgery or the Departments or Divisions in association with the affiliated     programs briefly described above. The consent is obtained during the patient's first     inpatient or outpatient encounter in parallel with the HIPAA consent. It can be withdrawn by     request of the patient at any time, but it does not expire unless the patient withdraws it,     or the patient severs their patient care relationship with UCI Neurosurgery or the affiliated     programs. The database is stored on a separate secure server maintained and backed up by the     UCIMC Information Technology Department. Access to the database is restricted at multiple     levels, with the majority of personnel allowed only limited access for data entry purposes.     Only the database programmer/coordinator, the Department Administrator and the Chairman of     the Department will have unrestricted access to the database. Authority for permission for     levels of security clearance and access to the database, for other individuals, will be     vested in the Chairman of the Department of Neurological Surgery.      A separate IRB proposal will be formulated for individual study related to the acquisition of     data from the de-identified database. Since these future studies will be performed on data     sets derived from the previously consented subjects of this IRB-approved project, the     requirement for additional consent forms are not anticipated. As a result IRB research     proposals utilizing the database can be expedited. Once the specific study is approved, the     investigator(s) are provided with the clinical information from the database in the form of a     de-identified data set.   "
209361|NCT00593424|"     The study examines the effect of two diets on fasting and post fat load lipoproteins of     subjects with type 2 diabetes with moderate hypertriglyceridemia.   "
209362|NCT00593437|"     Differences in determining bone density scores have been found when comparing different bone     density machines. Reducing differences between machines will improve diagnostic agreement for     patients measured at different clinics. This study will test if this difference exists     between the Norland Excel, such as the one at Wildwood Clinic, and the GE Healthcare Lunar     Prodigy at the UW Osteoporosis Clinical Research Center.   "
209363|NCT00593450|"     The purpose of the study is to evaluate the relative efficacy and safety of treatment of     neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a     variable schedule, and Avastin on a variable schedule.      A five year follow-up visit is being conducted in 2014 to gather information on long term     outcomes.   "
209364|NCT00593463|"     This study involves giving psychoactive drugs intramuscularly (injected into the muscle of     the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the     difference between one drug and another, as well as measuring the effects of the drugs on     mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each     subject will receive 2-4 of the listed interventions.   "
209365|NCT00593476|"     The purpose of this trial is to study the safety and efficacy of a pre-packaged, portion     controlled meal plan on weight loss and glycemic control in overweight and obese patients     with type 2 diabetes.      Aim 1 - Effects on Weight Assess the effects of a pre-packaged, portion controlled meal plan     on weight loss in overweight and obese patients with type 2 diabetes.      The researchers hypothesize that the pre-packaged, portion controlled diet (PCD) will produce     a greater weight loss than a diabetes support and education (DSE) program at 12 weeks. The     study will be powered to detect between group differences of 3% of body weight. Secondarily,     the researchers will assess whether there are any differences in weight during the secondary     phase from weeks 13-24 when both groups will consume a PCD diet.      Aim 2 - Effects on Glycemic Control      Assess the effects of a pre-packaged, portion controlled meal plan on glycemic control in     overweight and obese patients with type 2 diabetes.      The researchers hypothesize that the PCD will show greater improvement in HbA1c levels than a     DSE group at 12 weeks. The study will be powered to detect between group differences of .5%     in HbA1c. Secondarily, improvements and differences in HbA1c from weeks 13-24 when both     groups are consuming a PCD will be assessed.   "
209675|NCT00596076|"     The study is an intervention, Phase II COPCORD study. (COPCORD= Community Oriented Program to     Control Rheumatic Diseases). The purpose of this study is to find if Back School training has     any benefit on low back pain of the workers in a pharmaceutical factory in Tehran suburbs.   "
209366|NCT00593489|"     Family Physicians, the subjects of this trial are reluctant to initiate insulin in patients     with type 2 diabetes due to a lack of familiarity and comfort with this clinical strategy.     This study will test the effectiveness of diabetes specialist consultation support, and     community pharmacy insulin initiation support on the insulin prescribing behaviour of family     physicians across Canada.   "
209367|NCT00593502|"     The main purpose of this study is to assess the efficacy of early oseltamivir treatment     (started within 24 hours of the onset of influenza symptoms) in preventing the development of     acute otitis media as a complication of influenza in children aged 1-3 years.   "
209368|NCT00593515|"     Does parenting style affect emotion regulation among children who initially demonstrate high     levels of fear and anxiety? Although recent correlational research has demonstrated a linkage     between parental behaviors, such as excessive intrusiveness, and children's manifestations of     fear and anxiety, it is not clear if parenting behaviors directly influence children's     ability to regulate these emotions. Alternatively, these parental behaviors may be elicited     by children who express fears and anxieties more frequently than other children do.     Experimental research designs would offer a more definitive test of these competing     explanations of the extant correlational findings. Intervention studies, in particular, can     test whether experimentally manipulating current family interaction patterns affects     children's ability to regulate emotion. This study provides a preliminary experimental test     of the relationship between parental behavior and children's regulation of fear and anxiety.     Some 40 clinically anxious youth, aged 6-13, were randomly assigned to a family intervention     program for childhood anxiety problems, which includes extensive parent communication     training, or a child intervention program without parent-training. By comparing these two     interventions, we tested if it was possible to improve parenting behaviors—such as     intrusiveness—through intensive parent-training, above and beyond the effects of involving     children in a child intervention program. We then tested the impact of this change in     parental behaviors on children's ability to regulate fear and anxiety. We hypothesized that     parent-training would reduce intrusiveness, which would in turn improve children's anxiety     outcomes.   "
209606|NCT00586261|"     The hypothesis of the current proposal is that chronic pioglitazone therapy will result in     improved endothelial function, decreased inflammation, and preservation of renal function in     patients with CKD but without diabetes.   "
209369|NCT00593528|"     Transjugular intrahepatic portosystemic shunts (TIPS) have been increasingly used for the     treatment of complications of portal hypertension in patients with cirrhosis.      The initial experiment of the TIPS was reported during the 1990s with stents of various     brands, manufacture and sizes, but all non covered, thus owing the pseudointimal     hyperplasia growing inside the stent, which progressively decreases the diameter of the shunt     and thus its efficacy. Since the beginning of the 2000s, appeared stents known as covered     by polytetrafluoroethylene (PTFE) designed to reduce the obstruction rate and thus the     frequency shunt revisions. However, these stents are, on average, 2.5 times more expensive     than the non covered stents and the cost-effectiveness ratio of the TIPS according to the     type of stents used has not been assessed.      The aim of this multicentric and randomized study is to assess the cost-effectiveness ratio     of these 2 principles of TIPS, the one using stents covered by PTFE, relatively expensive but     seldom becoming obstructed, and the other using non covered stents, less expensive than PTFE     but requiring regular gestures of redilatation.      Population concerned: Patients with a cirrhotic portal hypertension responsible for:        -  recurrent variceal bleeding        -  refractory ascite (or hydrothorax)   "
209370|NCT00593541|"     This Protocol is intended to facilitate development and testing of new cardiovascular MRI     software capabilities by UC Davis Research Faculty, as well as to facilitate the evaluation     of new software capabilities provided by GE and Siemens.   "
209371|NCT00593554|"     The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an     improvement in treatment-related mortality (TRM) rate at 6 months.   "
209372|NCT00593567|"     The purpose of this study is to determine whether the gentamicin-collagen sponge when     combined with standard of daily wound care is safe and effective in treating mildly infected     skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily     wound care.   "
209373|NCT00593580|"     Women who undergo bilateral oophorectomy and receive chemotherapy are at risk of increased     bone loss. At present, despite having a risk factor profile that fits the indications for     assessment and treatment there are no routine interventions in this patient population i.e.,     the standard treatment is no treatment. We hope to identify whether or not an intervention     may be favorable in these women and change the standard of care in this vulnerable     population.      Hypothesis:      Weekly therapy with alendronate + vitamin D (FOSAVANCE) will improve bone health as measured     by DEXA scans in women with gynecologic malignancies undergoing chemotherapy as compared with     patients receiving placebo.   "
209374|NCT00593593|"     This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after     treatment initiation), and end of treatment phase (visit 3 - end of year 1). Only in the case     a serious adverse event (SAE) arises, will there be a follow up phase (visit 4).   "
209375|NCT00593606|"     This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of     switching from ropinirole therapy to the rotigotine transdermal system and its effect on     symptoms in subjects with idiopathic Parkinson's disease   "
209376|NCT00593619|"     The purpose of this trial is to compare the safety profile using equal doses of intravenous     iron dextran versus iron sucrose. The researchers hypothesize that significantly more     patients receiving intravenous iron dextran (using the current intermediate molecular weight     product) will have severe adverse outcomes than patients receiving iron sucrose in the adult     non-hemodialysis outpatient population. Secondly, since these severe reactions may require     additional nursing time and physician interventions that may negate any cost advantage of     iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than     iron dextran.   "
209377|NCT00593632|"     The study evaluates high fiber diet intake in patients with hyperlipidemia.   "
209378|NCT00593645|"     This study will test the combination of clofarabine, cytarabine, and thymoglobulin as a     non-myeloablative conditioning regimen for patients with myelodysplastic syndromes or acute     myeloid leukemia undergoing allogeneic stem cell transplant.   "
209524|NCT00595595|"     Millions of teeth are saved each year by root canal therapy. Although current treatment     modalities offer high levels of success for many conditions, an ideal form of therapy might     consist of regenerative approaches in which diseased or necrotic pulp tissues are removed and     replaced with healthy pulp tissue in order to revitalize teeth.   "
209379|NCT00593658|"     The Hepatopulmonary syndrome (HPS) results from intrapulmonary microvascular dilatation that     impairs arterial oxygenation in the setting of cirrhosis or portal hypertension. As many as     10-20% of cirrhotics being evaluated for orthotopic liver transplantation (OLT) have advanced     HPS and mortality is greater in those with HPS than in those without HPS. Currently, OLT is     the only effective treatment, although post-operative mortality in HPS is increased relative     to cirrhotic patients without HPS, with a one-year survival of between 68-80 %. Therefore, an     effective medical therapy for advanced HPS could improve both pre-operative and     post-operative mortality.      Recent work in experimental models of HPS has revealed that both nitric oxide     synthase-derived nitric oxide and heme oxygenase-derived carbon monoxide cause intrapulmonary     vasodilatation. These alterations appear to be driven in part by TNF-α modulation of     pulmonary blood flow and intravascular monocyte accumulation. Pentoxifylline is a nonspecific     phosphodiesterase inhibitor with inhibitory effects on TNF-α and has recently been shown to     be beneficial in patients with severe alcoholic hepatitis where TNF-α overproduction     contributes to liver injury. In experimental HPS, pentoxifylline administration also     decreases the severity of oxygenation abnormalities. However, pentoxifylline therapy has been     associated with dose limiting side effects in patients with liver disease and the     tolerability of pentoxifylline in cirrhotic patients with advanced HPS is unknown. Therefore,     this open label single arm clinical trial was designed to evaluate the efficacy and     tolerability of 8 weeks of pentoxifylline in cirrhotic patients with advanced HPS being     considered for OLT.   "
209380|NCT00593671|"     In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to     improve success rates after IVF, we test the hypothesis that patients with advanced maternal     age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally     normal embryos following PGS compared to patients who had an ET without PGS.      In a randomized controlled trial (RCT) in patients with AMA (≥ 35 years), the clinical IR per     embryo transferred will be compared after ET on day 5 or 6 between the PGS group (embryo     biopsy and analysis of chromosomes 13, 16, 18, 21, 22, X and Y) and the control group without     PGS.   "
209382|NCT00593697|"     The purpose of the study is to compare disease-free survival (DFS) of women treated with     concomitant trastuzumab plus docetaxel followed by FEC to that of the women treated with the     same regimen followed by single-agent trastuzumab to complete one year of trastuzumab     administration as adjuvant treatments of early HER2-positive breast cancer.   "
209383|NCT00593710|"     Marfan syndrome is a genetic disease of our connective tissue, which provides material and     support for our skeleton, muscles, blood vessels and other parts of our bodies. People with     Marfan syndrome may be tall and thin with slender, tapering fingers, long arms and legs, and     spine curvature. They often have heart and eye problems. In some patients, the condition is     very mild and the person has few or no symptoms. Others are always at risk of     life-threatening problems, which usually involve damage to the valves in the heart or     weakening of the large blood vessels leading from the heart. If the blood vessels become     weak, they can balloon out (dilate) and break (rupture), which might cause the person to die     suddenly. We have only a limited ability to stop the progression of disease in Marfan     syndrome. Typically we use medicines that lower heart rate or blood pressure (or both). But     this does not prevent the disease and very few drugs work well enough to keep patients from     needing surgery or dying suddenly because a blood vessel has torn open. Our objective is to     study two medicines to see if one, or both, can improve blood vessel function in patients     with Marfan syndrome. One (Atenolol) belongs to a group of drugs called beta blockers and is     often used to treat high blood pressure. It is the most common drug that is currently used to     treat patients with Marfan syndrome. The other (Losartan) is also used for high blood     pressure, but works in a different way. This study will help us to find better ways to treat     people who have Marfan syndrome and to identify early changes in blood vessel function that     may help to prevent long-term complications.   "
209384|NCT00593723|"     Concurrent chemotherapy and radiation therapy are the standard of care for inoperable     patients with esophagus cancer. Unfortunately, the 5-year survival of 20% for this population     is quite low. Methods to intensify radiation therapy delivery without increasing local     toxicities are needed. Intensity modulated radiation therapy (IMRT) is an advanced method of     delivering external beam radiation that may minimize the volume of normal tissue irradiated     to high dose and thus decrease the risk of normal tissue toxicity. The proposed study will     prospectively test whether IMRT is tolerable for delivering IMRT doses of 60 Gy for patients     with esophagus cancer.   "
209385|NCT00593736|"     The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to     advance the timing of sleep in individuals with delayed sleep phase syndrome.   "
209386|NCT00593749|"     The proposed research will evaluate the efficacy of an intervention in urban corner stores.     Community-based, environmental manipulation of corner stores is an understudied area and     represents the next step in understanding and improving the nutritional intake of school     students to prevent obesity.   "
209387|NCT00593762|"     The purpose of the study is to determine the response to aspirin (ASA) and Clopidogrel in     patients with peripheral arterial occlusive disease (PAOD) requiring interventional     procedures and to investigate if patients with resistance to ASA or Clopidogrel have an     unfavourable outcome during long-term follow-up   "
209388|NCT00593775|"     The successful hatching process is a prerequisite for implantation. Freezing/thawing cycles     can impair the hatching process by introducing changes in the composition of the zona     pellucida. The purpose of this study is to test the hypothesis that the implantation rate per     embryo and the clinical pregnancy rate per embryo transfer is higher after embryo transfer of     frozen-thawed embryos with opened or thinned ZP after assisted hatching when compared to     embryo transfer of frozen-thawed embryos without assisted hatching.      All patients starting a thawing cycle (with frozen embryos on d1-d2-d3-d5) can be included in     this RTC study. Assisted hatching will be performed with a non-contact 1.48 diode laser     system (MTG, Germany).   "
209703|NCT00597428|"     The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone     administration in patients with opioid-induced bowel dysfunction (OBD).   "
209389|NCT00593788|"     The aim of this study was to establish parameters for the Gaps-in-Noise test in     normal-hearing young adults. One hundred subjects (50 males and 50 females) received an     audiological evaluation to rule out hearing loss and auditory processing disorder. The     Gaps-in-Noise test was then conducted on all subjects. The mean gap detection threshold was     4.19 msec. A psychometric function by gap duration was constructed, revealing that the     percentage of correct responses was less than or equal to 5% for a gap duration of 2 msec,     10-30% for a gap duration of 3 msec, 60-70% for a gap duration of 4 msec, and over 96% for     gap durations of 5 msec or longer. The results suggest that the data obtained can be applied     as reference values for future testing. In the subjects evaluated, the Gaps-in-Noise test     proved to be consistent with low variability.   "
209390|NCT00593801|"     Objective: To investigate whether recombinant EPO reduces the need for transfusion in     extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.      The concentrations of trace elements and of antioxidant enzymes were investigated in all     patients, too.      Study population: 219 patient randomized into 3 groups   "
209391|NCT00593814|"     The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated     Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic     aneurysms.   "
209392|NCT00593827|"     The purpose of this study was to determine the effects of the weekly regimen of ixabepilone     dosing compared to the once every 3 week dosing regimen in participants with metastatic     breast cancer.   "
209393|NCT00593840|"     The purpose of this study is to determine if reducing or eliminating radiation treatment to     one or both sides of the neck where there is no evidence of cancer can help spare the side     effects of radiation treatment for head and neck cancer. In this study, the investigators     plan to reduce the amount of radiation treatment received to healthy tissue   "
209394|NCT00593853|"     The purpose of this study is to determine if methylphenidate improves fatigue in men     undergoing hormonal therapy for prostate cancer with an LHRH-agonist.   "
209433|NCT00594360|"     The purpose of this study is to evaluate the effect of a primary healthcare intervention     called 'Exercise on Prescription' aimed at increasing level of physical activity and     psychological parameters in a population of sedentary patients with increased risk of     developing lifestyle diseases. The effect is evaluated using patient-reported variables.   "
209395|NCT00593866|"     This is a research study for pancreatic cancer. One way of improving the results of current     standard treatments is to try new approaches. This study will examine the use of a more     advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT),     with chemotherapy. All subjects on this study will be treated with gemcitabine. This     chemotherapy agent has been used for patients with pancreatic cancer. The researchers have     already done studies using radiation therapy and gemcitabine. They want to build on the     information they have from this previous research. The researchers want to find the best dose     of IMRT that can be given at the same time that patients are receiving gemcitabine. To do     this, they will vary the total dose of radiation received by patients on this study based on     the information they have available from previously treated patients. The goal of the     research is to identify the highest dose of IMRT that can be given at the same time as the     chemotherapy without causing severe side effects.   "
209396|NCT00593879|"     Depressed patients will receive 6 weeks of citaloprma (20-40mg) therapy. Subjects who have an     inadequate response (partial or non-responder) will be randomized to receive either     mecamylamine (5-10mg) or placebo added to their citalopram for a further 8 weeks.   "
209397|NCT00593892|"     The purpose of this study is to determine if the type of surgery (orthopaedic, general     surgery, thoracic, etc.) affects the level of cytokines and thus potentially the risk of     multisystem organ failure.   "
209398|NCT00593905|"     Our goal is to determine clinically in Pulmonary Arterial Hypertension patients if     associations exist between the efficacy and toxicity of sitaxsentan, bosentan, and     ambrisentan and several gene polymorphisms in several key disease-specific and therapy     specific genes. Also characterized is the relationship between these polymorphisms and the     severity of Pulmonary Arterial Hypertension using either baseline hemodynamic or clinical     surrogates for disease severity.      Hypothesis: Polymorphisms influence the efficacy and toxicity of specific Pulmonary Arterial     Hypertension therapy as well as development/severity of PAH via their effect on PA     remodeling, drug response, or metabolism.      This study requires a one time 8.5 ml blood sample and clinical data to be obtained at     initiation of therapy, 4 months after initiation of therapy and 12 months after initiation of     therapy.   "
209399|NCT00593918|"     In this project we will study the capacity for single nucleotide polymorphisms (SNP) in TLR4     gene to induce varying levels of inflammatory chemokine and cytokine production.   "
209400|NCT00593931|"     This Protocol is intended to facilitate development and testing of new techniques for     functional MRI by UC Davis Research Faculty, as well as to facilitate the evaluation of new     techniques provided by the system manufacturers (GE and Siemens).   "
209401|NCT00593944|"     The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and     tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses     that patients may have to the drug will also be collected.   "
209402|NCT00593957|"     Increased brain glutamate and its N-methyl-D-aspartate (NMDA) receptors found in the brain of     younger Rett syndrome (RTT) patients cause toxic damage to neurons (the brain's nerve cells),     and contributing to EEG spikes. Dextromethorphan (DM) acts by blocking NMDA/glutamate     receptors. This study is being done to determine if DM will prevent the harmful     over-stimulation of the neurons thereby reducing EEG spike activity. Treatment with DM     consists of one of 3 different doses (0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day),     and aims to find out which dose if any will help improve EEG abnormalities, behavior,     cognition, and reduce seizures, as well as improve breathing abnormalities, motor     capabilities, bone density, and GI dysfunction.      The study will include 90 females and males with RTT, 2 years-14.99 years of age, with a     mutation in the methyl CpG binding protein 2 (MECP2) gene, and spikes on EEG, with or without     clinical seizures.   "
209403|NCT00593970|"     Pregnant women have limited knowledge regarding influenza, its implications during pregnancy,     and recommendations for vaccination during pregnancy. The researchers plan to distribute an     information pamphlet to women in a prenatal clinic, offer the vaccine during prenatal visits,     and then give a questionnaire on the postpartum floor assessing knowledge.      The researchers hypothesize that with education intervention, knowledge scores on the     questionnaire will be higher than those from last year, when no education was provided.   "
223939|NCT00783549|"     This study is the first study in humans to assess the safety and tolerability of various     doses of GSK1292263 alone, and taken with sitigliptan.   "
209404|NCT00593983|"     African Americans and Latinos are increasingly affected by HIV/AIDS in the United States.     Despite the increase in the number of infections in minority populations, these individuals     are not adequately represented in AIDS clinical trials (ACTs). The purpose of this study is     to identify effective intervention strategies to increase the number of HIV infected     racial/ethnic minorities and women who are screened for and enrolled into ACTs.   "
209405|NCT00593996|"     People who do not have adequate amounts of vitamin D develop weakness of leg and arm muscles.     This study will determine if vitamin D supplementation benefits muscle functions important     for swallowing, bladder and bowel function.   "
209406|NCT00594009|"     The purpose of this study to determine the safety and effectiveness of a mechanical device to     remove carbon dioxide from the blood of patients with chronic obstructive pulmonary disease     (COPD)when they are hospitalized in the intensive care unit for exacerbation of their     condition.   "
209407|NCT00594022|"     The purpose of this study is to determine whether a small electrical current to the     vestibular nerve (balance organ) will decrease the time it take for participants to fall     asleep.   "
209408|NCT00594035|"     To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural     repair compared with standard of care methods (control) to obtain watertight dural closure in     patients undergoing spinal surgery.   "
209409|NCT00594048|"     The purpose of this study is to determine whether breathing-exercises with the Resperate or     listening to a discman with freely chosen music are effective in the treatment of     hypertension   "
209434|NCT00594373|"     Topical microbicides, substances that kill microbes, are being studied to prevent sexual     transmission of HIV and other disease-causing agents. In the future, topical microbicides may     be applied vaginally to prevent both acquisition and transmission of HIV and other sexually     transmitted infections (STIs). The purpose of this study is to assess whether there is a     measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in     women at low risk for HIV infection.   "
209410|NCT00594061|"     The purpose of this study is to evaluate whether the Iowa/Nucleus 10/10 mm in one ear, in     conjunction with a Nucleus Freedom implant in the other ear can provide useful binaural     hearing in pediatric subjects who have bilateral severe to profound hearing loss and meet the     criteria for cochlear implantation. The Iowa/Nucleus 10/10 mm cochlear implant has a short,     10 mm electrode array that it is inserted only into the more basal region of the cochlea.     Unlike a conventional cochlear implant, the Iowa/Nucleus 10/10 mm is expected to preserve the     regions of the cochlear partition that are apical to the electrode, thus leaving them     available for possible future advances in the field of otolaryngology and hearing devices,     such as mammalian hair cell regeneration techniques or improved implantable hearing devices.     The Iowa/Nucleus 10/10 mm will be implanted in the contralateral ear from the Nucleus Freedom     electrode array as a means of providing bilateral stimulation of auditory pathways while     preserving the middle and apical regions of the scala media.   "
209411|NCT00594074|"     This pilot study looks at the relationship of moderate alcohol consumption on weight loss.   "
209412|NCT00594087|"     The purpose of this study is to determine if people with multiple sclerosis (MS) and fatigue     have disrupted sleep, as was suggested in previous studies, and whether treating the     disruptions of sleep improves the fatigue.      Eszoplicone, a new drug FDA approved for the treatment of insomnia, will be used to control     sleep disturbances in MS patients with fatigue.      The study will last 7 weeks, 5 of which will involve being on medication. You will take     eszopiclone or placebo (sugar pill), keep a sleep diary and wear an actigraph, a device about     the size of a digital watch that monitors and records sleep activity. You will randomly be     chosen to get either placebo or medication. Half the subjects will get placebo and half     eszopiclone. The decision will be made by a pharmacist (who does not know you) according to a     randomization table. Neither you nor the investigating physician will know whether you are on     sugar pill or medication. At both the beginning and the conclusion of the study you will be     asked to fill out 2 questionnaires to evaluate fatigue and depression and undergo some memory     and speech tests. The testing will take about 2 hours. Actigraphy is a wrist-worn, watch like     device that records activity during waking and sleeping without application of any sensors.     It consists of a movement detector, so it can record movement and non-movement data for a     week or two. You should wear it continuously during wakefulness and sleep as you go about     routine daily activities. You should only take it off if you are going to shower, bathe or     swim. A sleep log is a graph on which, for 2 to 3 weeks, you will record bedtime, approximate     sleep time, times and duration of awakenings during the sleep period, final awakening time,     and naps taken during the day to the best of your knowledge. You will also be asked to avoid     getting pregnant. If you are a woman who may have the potential to get pregnant then a     pregnancy test may be performed at the beginning of the study, before you receive the     medication, at the first follow up visit and when you end the study.   "
209413|NCT00594100|"     To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with     approved carotid stents to an Objective Performance Criterion derived from distal embolic     protection studies.   "
209414|NCT00594113|"     The primary purpose of this study is to determine the effectiveness of a multi-media     presentation and survey to increase screening for colorectal cancer. Content of this     presentation is based on the concept of implementation intentions, an advanced planning     model taken from the Theory of Planned Behavior. The multi-media presentation is delivered in     a touch-screen computer format and contains messages about colorectal cancer that are     tailored to each participant based on individual survey responses. It is hypothesized that     tailored messages and defining implementation intentions may have a relationship with     completion of colorectal cancer screening.   "
209415|NCT00594126|"     The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of     GRN163L when administered to patients with refractory or relapsed multiple myeloma.   "
209416|NCT00594139|"     Subjects with non-neurogenic over-active bladder will be enrolled. The hypothesis is that     augmentation cystoplasty using an autologous neo-bladder construct will increase functional     capacity and thereby reduce the number of micturition episodes per day in subjects with     non-neurogenic over active bladder and urge predominant incontinence.   "
209417|NCT00594152|"     Investigators with the goal of optimizing glycemic and blood pressure control saw type 1     diabetic patients weekly. A control group received 3-4 subcutaneous insulin injections per     day; an intravenous insulin pulsed infusion group received, in addition, three one hour     infusions in a pulsatile fashion over one eight hour period each week. Patients were followed     for 12 months with periodic testing of renal function by repeated blood and urinary analyses;     diabetes control by blood testing and diabetes impact measurement score; cardiac and     autonomic function by echocardiography, 24 hour electrocardiographic testing; and visual     changes with repeated fundus photography. The study hypothesis was that correction of     respiratory quotient would correct the defect leading to microvascular complications of     diabetes (Type 1).   "
209418|NCT00594165|"     The objective of this open-label extension is to assess the safety and tolerability of     long-term treatment of the rotigotine patch in subjects with early-stage idiopathic     Parkinson's disease.   "
209765|NCT00598273|"     The purpose of this study was to evaluate the safety and efficacy of peginesatide for the     treatment of anemia in participants with chronic kidney disease, who are not on dialysis and     not on erythropoiesis stimulating agent (ESA) treatment.   "
209419|NCT00594178|"     Spinal cord injury (SCI) leads to muscle atrophy, hyperreflexia and spasticity, symptoms that     decrease quality of life and prevent effective rehabilitation. Previous findings from our     labs found that a passive cycling exercise program, motorized bicycle exercise training     (MBET), in adult spinally transected animals reduced muscle atrophy and normalized     hyperreflexia. We found that MBET could prevent the onset of hyperreflexia after spinal     transaction, that MBET could also be used to rescue from hyperreflexia once it had set in,     and that MBET could induce savings in normalization of reflexes after MBET ceased. We also     demonstrated that MBET was effective in rescuing from hyperreflexia in a chronic ASIA B SCI     patient, and that short-term MBET could lead to brief savings in normalization of reflexes     once MBET ceased. The proposed studies will test the ability to MBET to prevent the onset of     hyperreflexia in a group of acute SCI patients trained before hyperreflexia has had a chance     to set in. In addition, the proposed research will attempt to confirm the possibility that     long-term MBET in chronic SCI patients will rescue from hyperreflexia once it has set in, and     also produce significant savings in normalization of reflexes if carried out for long periods     of time. We will also test the possibility that MBET in acute and/or chronic SCI patients     could reduce or prevent muscle atrophy. The experimental design calls for assessing muscle     mass using MRI scans, bone density using Dual-Energy X-ray Absortiometry (DEXA) scans,     spasticity measures and electrophysiological measurements to determine low frequency     habituation of the H-reflex. Assessments will be carried out before MBET, during a 25 week     MBET block of time, and during a 12 week post MBET monitoring period. Changes in muscle mass,     bone density, spasticity scales and H-reflex habituation will be compared across these     interventions and between treated SCI victims and a group of control acute and chronic SCI     victims undergoing standard of care during the same period.   "
209420|NCT00594191|"     The purpose of this study is to evaluate the effects of continuous simvastatin administration     on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its     safety in patients with cirrhosis and portal hypertension.   "
209421|NCT00594204|"     The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline     compared to placebo for smoking cessation. Abstinence from cigarette smoking and other     tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period     will also be evaluated.   "
209422|NCT00594217|"     The rapidity with which progesterone (P) suppresses daytime lutenizing hormone (LH) (and by     inference gonadotropin releasing hormone (GnRH)) pulse frequency is unknown. We propose to     assess this further using a randomized, cross-over, placebo-controlled study. Ovulatory women     will begin E2 patches on day 4-8 of the cycle, while women with PCOS will begin E2 patches     either on day 4-8 of the cycle or at least 8 weeks post-menses. After 3 d of E2     administration, women will undergo a 24-h sampling study in the GCRC. Beginning at 2000 h,     blood for LH, FSH, E2, P, and T will be obtained over a 24-h period. After 10 h of sampling,     either oral micronized P (100 mg p.o.) suspension or placebo suspension will be administered     (according to randomization). At the completion of sampling, E2 patches will be discontinued.     During a subsequent menstrual cycle (or after at least 3 weeks in oligomenorrheic PCOS),     subjects will undergo another GCRC study identical to the first (including pretreatment with     E2) except that oral P will be exchanged for placebo or vice versa in accordance with the     crossover design. We will assess the acute effects of progesterone on LH frequency, with     secondary endpoints being mean LH, LH pulse amplitude, and mean follicle-stimulating hormone     (FSH). We propose two primary hypotheses: (1) administration of P (at 0600 h) to normally     cycling adult women during the follicular phase will result in a demonstrable suppression of     daytime LH (and by inference GnRH) pulse frequency within 12 hours; (2) administration of P     (at 0600 h) to women with PCOS will result in less suppression of daytime LH pulse frequency     than in ovulatory women without PCOS. A secondary hypothesis is that augmentation of LH     amplitude after P administration will be less in PCOS compared to normal controls.   "
209423|NCT00594230|"     This will be a single arm Phase II study.   "
209424|NCT00594243|"     This pilot feasibility experimental study is designed as a randomized wait-list controlled     trial of mindfulness meditation for CLBP. A sample of 37 older adults 65 years of age and     older will be recruited from a chronic pain clinic, posted flyers, and newspaper     advertisements over a 6-month period. Eligibility will be determined by self-report from a     checklist reviewed with potential participants over the phone (see appendix for checklist).     Pre-intervention study participants will be consented and study measures obtained. After     consent and baseline measures, participants will be randomized in blocks of six using a     simple randomization process with no stratification using a table of random numbers. After     randomization, participants in the intervention group will receive the intervention of eight     weekly 90-minute mindfulness meditation sessions. Instead of waiting until all 37     participants have been recruited into the study to do the intervention, the intervention will     be done on a rolling basis. This means there will be a minimum of 6 participants per     intervention group, with the possibility of three separate intervention groups. If     recruitment goes better than expected, then we will offer the intervention to all 18     participants at one time. Controls will not receive any intervention during this time.     Immediately post-intervention the measures will be administered again to participants and     wait-list controls. Once the intervention is complete and participants and wait-list controls     have completed post-intervention measures the mindfulness meditation program will be offered     to the wait-list controls. We will try to combine the wait-list controls into one eight-week     program. 3 months after the intervention is completed, participants will be asked to complete     the measures a third time and any mindfulness meditation they continue to do at home will be     quantified.      The primary hypotheses are:        1. We expect to be able to recruit 37 eligible individuals with CLBP into the study within          a six-month period.        2. We expect participants randomized to the mindfulness meditation intervention to meet an          adherence standard of attending 75% of the 8 weekly 90-minute sessions.        3. We expect mindfulness meditation will result in a moderate effect size difference (0.5)          between the intervention participants and wait-list control participants on outcome          measures of pain, mood, physical function, attention, and QOL.   "
209425|NCT00594256|"     The present protocol proposes study of the recently approved compound sodium oxybate (Xyrem),     a gamma-aminobutyric acid type b (GABAB) and a g-hydroxybutyric acid (GHB) receptor agonist,     for the study of persistent symptoms of schizophrenia. Sodium oxybate is a central nervous     system depressant currently approved for treatment of narcolepsy associated with cataplexy     and excessive daytime sleepiness. In addition to evaluating effects on sodium oxybate on     persistent symptoms and neurocognitive deficits in schizophrenia, the study will test the     hypothesis that this medication may be particularly effective in combating Insomnia Related     to Schizophrenia, and in normalizing symptomatic and polysomnographic manifestations of     sleep-related brain dysfunction in schizophrenia.   "
209426|NCT00594269|"     The aim of this study is to discontinue antipsychotics and antidepressants, and to study its     effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).   "
209427|NCT00594282|"     The objective of this study is to assess whether use of a mammography breast plate cushion     will significantly decrease the level of discomfort experienced by African American women     during routine screening mammograms. The primary hypothesis is that use of the breast plate     cushion will result in less mammography-related discomfort. The secondary hypotheses are that     women who anticipate high levels of discomfort will experience greater reductions in     discomfort when a breast plate cushion is used and participants who received mammograms using     a breast plate cushion will have greater intentions to return for a routine mammogram than     the control group.   "
209428|NCT00594295|"     Brittle and broken bones can occur after organ transplantation. However, the long-term     effects of bone marrow transplantation on bone health and the risk of breaking bones are not     well understood. This study will help to assess how common it is for those who have received     a bone marrow transplant to have fractures. It will also investigate blood tests related to     bone health. This will be done by measuring bone mineral density and obtaining blood tests.   "
209429|NCT00594308|"     The purpose of this study is to compare the effects (good and bad) of the medication     basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of     graft-versus-host disease.      This research is being done because there is no completely safe and effective prevention for     graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to     know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after     a transplant known as nonmyeloablative (mini transplant).   "
209430|NCT00594321|"     The objective of the clinical trial is to evaluate the SPACE 360 Delivery System using SPACE     CpsXL Bone Cement compared to standard vertebroplasty in the treatment of pathological     fractures of the spine caused by metastatic tumors of the spine, myeloma, or lymphoma. Up to     a total of three levels per patient may be included or five levels for multiple myeloma. The     control group will be standard vertebroplasty.   "
209431|NCT00594334|"     Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial     periodontal effects.   "
209432|NCT00594347|"     The present study intends to investigate the use as a booster of a dose of sanofi pasteur's     Pneumo 23 vaccine in the second year of life following 3-dose priming with Wyeth's Prevnar     vaccine. The researchers will use a cohort of subjects who have received 3 doses of Prevnar®     at 2, 4, 6 months of age in the context of the clinical study A3L12 on Hexavalent combined     vaccine (DTaP-IPV-HB-PRP~T)   "
209435|NCT00594386|"     The objective of this open-label extension is to assess the safety and tolerability of     long-term treatment of the Rotigotine patch in subjects with advanced-stage idiopathic     Parkinson's Disease.   "
209436|NCT00594399|"     This study targets older adults (ages 60 and over) who are overweight (body mass index 25-40)     with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled     clinical trial (n=300) to determine the effect of a one-year physical activity counseling     intervention on glucose metabolism and secondary outcomes compared to usual care.   "
209437|NCT00594412|"     This study will determine whether a magnetic resonance imaging (MRI) test of the liver can     accurately measure the amount of fat in the liver compared to the results of a liver biopsy.      People 18 years of age and older who are scheduled to have or who have already had a liver     biopsy as part of their medical care within 1 month of enrollment in this study may be     eligible to participate.      Participants undergo an MRI. For this procedure, the subject lies still on a table that     slides into a narrow metal cylinder (the MRI scanner) for 30 to 60 minutes. A special pad or     tube is placed around the abdomen to improve the image of the liver obtained. Earplugs are     placed in the ears to muffle loud thumping and knocking sounds that occur with the electrical     switching of the magnetic field. The findings of the MRI are compared with those of the liver     biopsy.   "
209438|NCT00594425|"     This multicenter study will be divided into 2 phases. The first phase will be an open label,     dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled,     parallel-group, dose-response phase. The second phase will only start if the first phase     succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne     vulgaris in the face will be included.The results from part 2 has been presented in the     result section.   "
209439|NCT00594438|"     The purpose of this study is to compare the quantity of fat that is released into the venous     system (blood) by reaming the femoral canal during intramedullary nailing of the femur using     two different reaming systems.   "
209440|NCT00594451|"     The objective of the proposed study is to assess the role of smoking and complex gene-smoking     interactions in two understudied Rheumatoid Arthritis (RA)groups.   "
209441|NCT00594464|"     Evaluation of efficacy and safety on the use of rotigotine in patients suffering from     Parkinson's Disease during and after surgery requiring general anaesthesia.   "
209442|NCT00594477|"     This study delivers radiation therapy to any residual breast tissue and the chest wall plus     lymph node areas around the breast. These lymph node areas are under the arm, around the     collar bone, and under the sternum (breastbone).   "
209443|NCT00594490|"     This trial will evaluate the outcome of placement of silicone breast prosthetics.   "
209444|NCT00594503|"     Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in     patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.   "
209445|NCT00594516|"     The objective of this study is to test the idea that the immediate-release (IR) form of     tapentadol (CG5503) can be directly converted into an approximately equivalent total daily     dose (TDD) of the extended-release (ER) form, and vice-versa, with equivalent safety and     efficacy.   "
209446|NCT00594529|"     The purpose of this study is to evaluate the safety of liver resection for metastatic,     resectable lesions from colorectal cancers after systemic chemotherapy.   "
209447|NCT00594542|"     The purpose of the study will be to demonstrate whether Mohs micrographic surgery can be     performed with a lower total dose of local anesthesia (and greater patient safety) when using     0.5% lidocaine with 1:200,000 epinephrine versus 1% lidocaine with 1:100,000 epinephrine.   "
209448|NCT00594555|"     The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG     regimen) with Imatinib Mesylate (Gleevec) in patients with AML.   "
209540|NCT00585377|"     In an attempt to improve the therapeutic index for initial therapy of metastatic NSCLC, the     combination of bevacizumab and erlotinib is being proposed as first-line treatment in place     of conventional chemotherapy. This trial is intended to provide pilot data for a future     randomized trial of this combination of targeted agents versus conventional chemotherapy for     advanced NSCLC.   "
209449|NCT00594568|"     Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no     cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta-amyloid     (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD     patients are required to have these amyloid plaques in the brain in order to have a     definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the     production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and     was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in     blood, spinal fluid, and brain in animals tested thus far. This study used several different     tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some     participants. The build-up of amyloid plaques was measured by a brain scan that takes a     picture of amyloid plaques in the brain. Other tests measured the overall function of the     brain and brain size in some participants. In this trial, participants who initially received     placebo (inactive sugar pill) were, at a certain point in the study, switched over to active     drug, semagacestat. In other words, all participants could eventually receive active drug.     Participation could last approximately 2 years. Participants taking approved AD medications     were permitted to participate in this study and continue taking these medications during the     study. All participants who completed this study had the option to continue receiving     semagacestat by participating in an open-label study.      Preliminary results from this study (H6L-MC-LFAN [LFAN]) and another similar study     (H6L-MC-LFBC [LFBC; NCT00762411]) showed semagacestat did not slow disease progression and     was associated with worsening of clinical measures of cognition and the ability to perform     activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC, and     open-label H6L-MC-LFBF (LFBF; NCT01035138) were amended to continue collecting safety data,     including cognitive scores, for at least 7 months. The Clinical Trial Registry (CTR) will     reflect results of analyses from the original LFAN protocol in addition to those from the     amended LFAN protocol.   "
209450|NCT00594581|"     This study was undertaken to investigate safety and scar-improvement activity of different     applications of Juvista (avotermin), administered to surgical incisions made to the skin of a     healthy population of male volunteers aged 18-45 years. The study addressed two issues:     whether Juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more     effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once     only (before wounding) or twice (before and after wounding) is optimal for scar improvement.   "
209451|NCT00594594|"     We hypothesize that probiotic Lactobacillus can augment antibiotic treatment of symptomatic     urinary tract infection (UTI) in spinal cord injured patients, and also increase the time to     the next episode of UTI.   "
209452|NCT00594607|"     The purpose of this study is to investigate whether the dialysis filter AN69ST (Nephral 400     ST Dialysis Membrane) induces less clotting during hemodialysis than a conventional     polysulphone filter. Our hypothesis is that the two filters induce the same degree of     clotting.   "
209453|NCT00594620|"     To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are     being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control     of advanced prostate cancer   "
209454|NCT00594633|"     A significant number of brain tumor patients who received radiation or chemotherapy have     thinking problems as a result of their treatment. The purpose of this study is to find out if     treatment with Aricept (donepezil) may improve some aspects of thinking abilities in patients     with brain tumors who received radiation or chemotherapy. This research will also study     whether persons having particular genes for a blood-borne substance called apolipoprotein E     (APOE) are more likely to have thinking problems after radiation or chemotherapy treatment     for their brain tumors. The findings of this study will help us find out whether Aricept can     improve thinking abilities after cancer treatment, and whether some of the thinking     difficulties may be in part related to having certain genes.   "
209455|NCT00594646|"     This study will evaluate how safe and tolerable a combination of taking three-drugs will be     for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in     HIV uninfected adults.   "
209456|NCT00594659|"     More US residents are dependent on marijuana than on any other illicit drug, and the number     enrolled in treatment for marijuana continues to increase such that it is now comparable to     that for cocaine and heroin. This application seeks to advance the overarching goal to     develop and disseminate cost-effective treatments for marijuana dependence that can address     this growing problem.      The researchers' previous research suggests that an intervention comprising motivational     enhancement, cognitive-behavioral, and contingency-management components (MET/CBT/CM)     produces greater rates of successful and durable outcomes than has been demonstrated     previously. However, three issues relevant to its efficacy and eventual dissemination must be     confronted. First, the outcomes achieved can only be characterized as modest; many     individuals do not respond to the treatment and relapse rates remain problematic. Second,     access is limited by the availability of trained providers. Third, the cost of delivering the     treatment is higher than more traditional outpatient interventions.      To address these issues, Specific Aim 1 is to develop and test a computer-assisted version of     MET/CBT/CM. Computerized treatments have the potential to increase overall effectiveness of     treatment services by increasing availability of and access to potent treatments, and by     applying innovative technology to enhance outcomes. During Year 1, the intervention will be     developed and pilot tested. An interactive program that showed promise in a previous trial     for opioid dependence will be modified and enhanced to deliver individualized MET/CBT/CM     using effective computer learning technologies. These technologies and access to the     MET/CBT/CM program made available via the Internet between treatment sessions and after     treatment ends have the potential to promote better learning and more use of coping skills,     which in turn can improve outcomes. During Years 2-4 a randomized trial will provide an     initial efficacy test of cMET/CBT/CM by comparing it with a brief treatment (MET) and with     therapist-delivered MET/CBT/CM. Specific Aim 2 is to learn more about how behavioral     treatments like MET/CBT/CM work by focusing on two putative mechanisms of action examined in     prior trials: self-efficacy/coping skills and impulsivity/delay discounting. The experimental     design will provide a unique opportunity to explore such mechanisms in a novel context- where     the therapist is vs. is not a prominent part of the treatment.      The proposed project will address the objectives of NIDA's Behavioral and Integrative     Treatment Development Program by providing research on technology-assisted treatment that     attempts to make treatment delivery less complex, easier to access, and less costly - while     retaining or improving its effectiveness. Findings will inform future studies designed to     refine the technology and how it is applied; conduct more definitive effectiveness testing;     test generality to other populations including adolescents; and to further advance     translation to community settings.   "
209457|NCT00594672|"     This study is a 5-year extension of the AREDS protocol, in which investigators followed the     natural course of age-related macular degeneration (AMD) and cataracts. Participants in the     former AREDS protocol are eligible for this study.      Participants have a complete eye examination once a year and are contacted at least once a     year between visits to check on their status. The eye examination includes measurement of     visual acuity (vision chart test) and examination of the inside of the eye after the pupils     have been dilated with eye drops. Photographs of the inside of the eye may be taken using a     special camera that flashes a bright light in the eye. A blood sample may be obtained to test     for cholesterol level and genes related to inflammation.   "
209458|NCT00594685|"     Heparin-induced thrombocytopenia (HIT), a condition characterized by low platelet levels and     possible blood clots, occurs in a small number of people after treatment with the drug     heparin. Some people with HIT may show symptoms of a blood clot at the time of HIT diagnosis,     but in another form of HIT, known as isolated HIT, people do not show blood clot symptoms     even though they might have a blood clot. This study will use ultrasound tests to evaluate     the presence of blood clots at the time of an HIT diagnosis and in the following month.   "
209459|NCT00594698|"     The purpose of this study is to evaluate preparation and administration of PB127,     echocardiographic images obtained during PB127 administration, and evaluate the safety of     PB127.   "
209460|NCT00594711|"     Outcome of psychodynamic psychotherapy measured by [123I] nor-B-CIT SPET imaging      Background Psychodynamic psychotherapy is a widely practised form of psychotherapy in the     treatment of depression. There is evidence that serotonin transporter (SERT) densities are     altered in depression. Preliminary observations have suggested that SERT function may recover     in connection with dynamic psychotherapy.      The objective was to determine whether SERT densities change in relation to clinical recovery     during psychodynamic psychotherapy.   "
209461|NCT00594724|"     The purpose of this study is to see how the brain re-learns to control the tongue in speaking     and swallowing when either portions of the tongue have been removed, or when the tongue has     been treated with radiation, in order to treat cancer. We hope the results of this study will     help us to improve healing for patients who are being treated for cancer of the tongue.      When patients with cancer of the tongue are treated by removing parts of the tongue (surgery)     or by destroying the cancer with radiation to the tongue, they have significant difficulty     speaking and swallowing after such treatments. At this time, patients who have been treated     for cancer of the tongue re-learn speaking and swallowing through exercises taught by a     speech pathologist.      What is needed is information on how the brain re-learns to control speaking and swallowing     so that we can help these patients re-learn faster after their treatments.   "
209541|NCT00585390|"     The purpose of this research study is to find out what effects (good and bad) that omega-3     fatty acids has on schizophrenia.   "
209462|NCT00594737|"     Memantine has been approved for use in Alzheimer's disease. Its mechanism of action raises     questions of whether it can also be effective for non-Alzheimer's dementias such as     frontotemporal dementia (FTD), which currently has no disease-modifying treatment.      This is an open-label study to probe the effects of memantine in 15 outpatients diagnosed     with FTD, as shown objectively by comparing PET scans performed before and after use of the     medication. The specific type of PET scan, FDG-PET, allows the investigators to gauge the     effects of memantine on cortical activity levels. The investigators hypothesize that subjects     on memantine will show normalization of cortical metabolic activity.   "
209463|NCT00594750|"     The purpose of this study is to identify the causes of asthma that were not previously     suspected, to better understand the effects of inhaled steroids on asthma and to identify new     way to treat asthma.   "
209464|NCT00594763|"     In the literature, cases of thrombosis in the venous system have been described in girls and     women with Turner syndrome. By screening a group of women with Turner syndrome, the     researchers wish to find out if this condition is more frequent in this patient population.   "
209465|NCT00594776|"     The purpose of this study is to determine the ability of a cone beam CT to measure bone     healing.   "
209466|NCT00594789|"     The objective of this study is to evaluate a post-fracture intervention for improving     osteoporosis care in older men and women who have suffered a fracture that may indicate the     presence of osteoporosis. Although osteoporosis can be identified with a bone mineral density     (BMD) test, most individuals with osteoporosis are not diagnosed until they fracture.     Post-fracture care often falls between the cracks when there is a breakdown in     communication between hospital and community, or between specialists and primary care     physicians. Often physicians and patients fail to make the connection between an acute     fracture and osteoporosis, or the value of secondary prevention strategies. If untreated,     there is an extremely high rate of additional fractures after a first osteoporotic fracture.     It follows that improving BMD testing and/or treatment in appropriately identified     individuals is a necessary step in optimizing post-fracture patient care. Over the next three     years we will be testing and optimizing a notification procedure to physicians and/or     patients relying upon fracture events reported to the provincial health service (Manitoba     Health).   "
209602|NCT00586209|"     To primary purpose is to evaluate the effect of L-glutamine therapy on exercise endurance and     breath by breath exercise response of sickle cell anemia patients      The secondary purpose is to assess the effect of L-glutamine on pain; energy and appetite     levels; narcotics usage; and hospital and emergency room visits for sickle cell pain   "
209467|NCT00594802|"     Allergy skin tests and allergen immunotherapy are common procedures for both the diagnosis     and treatment of atopic diseases. Allergen immunotherapy has proved to be effective in     reducing the symptoms of allergic rhinitis and asthma1-2. Despite its clinical benefit, there     is risk of systemic reactions associated with these procedures.      The systemic reaction rate to skin testing for aeroallergens is significant lower than the     rate of reactions to immunotherapy, but it is not negligible. Lin et al reported only 2     patients who had systemic allergic reactions to skin testing for respiratory allergies in     10,400 patients tested.3 They determined the overall risk of inducing anaphylactic reactions     by skin testing to be less than 0.02% and other studies have produced similar results.4-5 The     rate of systemic reactions to skin testing is likely underscored. Thompson et. al reported a     systemic reaction rate of 6% of patients receiving skin testing.6 It is important to     recognize the risk of systemic reactions seeing skin testing is commonly done. It is also     imperative to recognize the treatments for these reactions to prevent progression.      Hypothesis The systemic reaction rate to allergen immunotherapy and skin testing to     aeroallergens is higher than previously reported. Biphasic anaphylactic reactions rarely     occur with allergen immunotherapy and skin testing.   "
209468|NCT00594815|"     The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy     is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare     tumor. It is usually treated with chemotherapy and radiation. This combination prolongs     survival, but about half of patients relapse. The investigators hope that the addition of     rituximab will improve the control of the tumor.   "
209469|NCT00594828|"     To test the hypothesis that home international normalised ratio (INR) monitoring with     supervised patient self-testing (PST)can provide comparable or superior time in therapeutic     range (TTR) to that provided by traditional outpatient anticoagulation.   "
209470|NCT00594841|"     The purpose of this study is to compare non-operative treatment versus operative treatment in     patients who suffer a complete, acute acromioclavicular (AC) joint dislocation. This study     will show if one method is superior to the other and will also show advantages and     disadvantages associated with each treatment method.   "
209471|NCT00594854|"     This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6     months duration is designed to assess the efficacy, tolerability and safety of PN400 versus     diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric     ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per     arm).      At least 20% of the subjects enrolled will be age 65 years and older.   "
209472|NCT00594867|"     Aspirin is a medication commonly used to relieve minor pains. Aspirin has also been used to     prevent heart attacks and strokes. Aspirin, however, can also cause damage to the stomach     and/or intestinal lining leading to the development of erosions (small sores) and/or ulcers     (large sores). Erosions may cause bleeding (bleeding ulcers) and/or perforations (holes     in the stomach). Acetaminophen, often referred by the brand name, Tylenol, is also used to     treat minor pains but is not commonly recognized to cause damage to the stomach lining.      Many patients often take both of these medications together. While the effects on the stomach     lining of each medication, when used alone, are known, the effects of both medications, when     used together, are not.      The purpose of this study is to show whether or not the collective effects of both aspirin     and acetaminophen, when used together, increase the damage on the stomach lining when     compared to either medication alone.   "
209473|NCT00594880|"     The objective of the study is to compare two different doses of Peg-INF-α-2A (90 or 180     ug/wk) for their ability to maintain viral control when initiated 5 weeks before ART     (antiretroviral therapy) interruption in HIV positive, ART-suppressed subjects (viral load     <50 copies/ml) as determined by observing the percentages of viral load measurements <400     copies/ml between the two arms over a 24-week period, corresponding to the Pegasys     monotherapy period (exclusive of dual ART/Pegasys 5-week period). Primary analysis will be an     intent to treat analysis and will address the hypothesis that two different doses of     Peg-INF-α-2A (90 and 180 ug/week) will be similarly effective at inhibiting viral     replication.   "
209474|NCT00594893|"     The purpose of the research is to determine if there is a difference between two of the     commonly used less invasive techniques (surgical methods that use a smaller incision or cut     in the skin) used to perform total hip arthroplasty (replacement of your painful hip with a     new ball and socket). It is unclear which of these techniques is associated with a faster     recovery and lower risk of complications.   "
209475|NCT00594906|"     The purpose of this study is to compare the effect of the drug teriparatide to the effect of     placebo on pelvic fracture healing.   "
209476|NCT00594919|"     The following objectives were used for comparison: 1)primary objective: Evaluate the urinary     excretion of NGAL as a marker of early development of acute kidney injury in patients     undergoing cardiac surgery.   "
209477|NCT00594932|"     We hypothesize that mycophenolate mofetil(Cellcept)is safe and effective for lupus arthritis.     In this study, patients with lupus will be randomly assigned to receive mycophenolate mofetil     or placebo (inert pills) for three months. At the end of three months all patients will     receive mycophenolate mofetil for three additional months. The effectiveness on arthritis and     other symptoms of lupus will be measured by joint counts and by the BILAG instrument (a     measure of overall lupus disease activity. Additionally special blood tests aimed at     understanding the biologic effects of mycophenolate mofetil will also be performed at some     visits. The primary outcome measurement will be the safety and effectiveness of this     treatment (as compared to placebo) at the three month point. The trial will continue in a     blinded fashion (neither the investigator or the participants know who is getting     mycophenolate and who is getting placebo) until 24 patients have completed the first three     months of the protocol.   "
209478|NCT00594945|"     Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.   "
209479|NCT00594958|"     The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean     Titers for anti-JEV neutralizing antibody.   "
209560|NCT00585637|"     This study will help us know the effects of Vitamin D pills in Blacks. The results of this     study may be the first step in creating ways to prevent the risks of colon and prostate     cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among     Blacks. This study will find out if Vitamin D pills can increase Vitamin D to healthy levels     in our bodies.   "
209480|NCT00594971|"     Background:      Approximately one third of all deaths in Denmark are caused by cancer. Both Danish and     international research shows that the majority of terminally ill cancer patients wish to die     at home. In Denmark only about 25% has this wish fulfilled. The General Practitioner (GP) has     traditionally had the full responsibility for the palliative care of terminally ill cancer     patients. In recent years changes have been made to the organisation of palliative care: some     hospitals have set up specialised palliative care teams and in some areas of Denmark hospices     have been established.      Recent research defines a problem when it comes to communication between the hospital and     general practice when the patient is being discharged. This is often done in a way that can     cause the patient to feel left in limbo, especially if it is not completely clear to the     patient and his or her relatives who has the responsibility for the palliative care.      Objective:        1. To describe consequences for patients, relatives and health care professionals of three          different ways of organising palliative care        2. To collect data which describes patients who are candidates to a shared care approach          between general practice and a specialised palliative care team        3. To collect data which describes the palliative phase (place of death and palliative          care, admissions to hospital, involvement of GP and district nurse etc.)        4. To describe terminally ill cancer patients and their relatives expectations of the          health care system      270 terminally ill cancer patients will be invited to take part in the study. Data will be     collected by interview with patients and questionnaires for patients, relatives and involved     health care professionals.   "
209481|NCT00594984|"     Part 1: To define the recommended dose of brivanib that can be safely administered in     combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic     colorectal cancer (MCRC)      Part 2: To compare median duration of progression free survival (PFS)   "
209482|NCT00594997|"     Our overall goal is to develop, implement, evaluate and disseminate an effective and     generalizable program to reduce Lyme disease in endemic areas through introducing a     school-based intervention to children and families. We will:      1. Deliver an educational program in schools to promote personal protective practices,     encourage early disease detection and modify residential habitats to reduce tick density.      3. Evaluate the program's efficacy by comparing the acceptability and practice of     precautionary behavior, tick density in residential areas and rates of Lyme disease between     groups using primary and surveillance data sources Evaluate the contribution of knowledge,     attitudes, and parental involvement to children's adoption of prevention strategies.      4. Obtain data on the use of single dose tick bite prophylaxis in children and families.      5. Evaluate the cost of the intervention in relation to its impact on incidence of Lyme     disease.      Hypothesis      The community intervention will reduce the incidence of Lyme disease among children and     families living in endemic areas by increasing the practice of precautionary behavior and     reducing tick density in residential areas. Specifically, we hypothesize that:        1. The educational intervention will reduce the incidence of Lyme disease among children          and families living in an endemic area.        2. The educational intervention will improve the childrens' self-confidence (behavioral          self-efficacy), intention to perform, and actual practice of Lyme disease prevention          behaviors.   "
209483|NCT00595010|"     This study will determine the effectiveness of a complex parent training program, based on     the SafeCare model, in reducing the occurrence of child maltreatment.   "
209484|NCT00595023|"     This study is designed to collect data about the amount of time required to use the assay in     clinical-use conditions.   "
209485|NCT00595049|"     The main purpose of this study is to investigate whether bosentan (Tracleer®) affects the     wall thickness of the pulmonary arteries in patients with idiopathic pulmonary arterial     hypertension (iPAH) and PAH related to systemic sclerosis (PAH-SSc).      The second purpose is to investigate if bosentan affects the enlargement of small vessels in     the lungs in response to natural chemicals in patients with iPAH and PAH-SSc.   "
209486|NCT00595062|"     This study was started to validate the possibility of administering radiation therapy during     surgery to the tissue surrounding the tumor once the tumor has been removed. This surrounding     breast tissue is at greater risk for developing breast recurrences. This treatment may be as     effective as the conventional 5-6week radiation treatment in reducing the risk of further     local recurrences after breast-conserving surgery.      Through this study, we would like to confirm that this procedure is a safe alternative to     conventional breast radiation, with no additional side effects when compared with the     conventional surgery and radiation therapy.   "
209487|NCT00595075|"     Night shift-workers are often advised to take a prophylactic nap prior to starting the shift     in order to improve alertness and performance. However, individuals often report difficulty     initiating and maintaining sleep at that time of the day secondary to the alerting influence     of the near-24 hour circadian rhythm (biological clock). A sleep-promoting medication may     improve the quality of an evening nap and subsequent alertness and performance during a night     shift. We will use Ramelteon, a melatonin agonist that is FDA approved for insomnia, in order     to test the following hypotheses:        1. ramelteon, compared with placebo, will significantly increase sleep efficiency during a          2-hour nap;        2. sleep inertia, as assessed by neurobehavioral tests and subjective and objective          sleepiness assessments will not be significantly increased after ramelteon treatment          compared with placebo treatment; and        3. neurobehavioral performance, subjective and objective sleepiness, and subjective mood          during a simulated 8-hour night shift will be significantly improved when ramelteon is          given prior to a prophylactic nap compared to a prophylactic nap with placebo.   "
209496|NCT00595205|"     GSK Biologicals' rotavirus vaccine, Rotarix™ has been recommended for universal use targeting     infants through the Expanded Program on Immunization (EPI) in Mexico. This protocol describes     a Phase IV safety study in Mexico designed to further evaluate the safety profile of Rotarix™     with regard to intussusception (IS). The data generated by this study will be useful for     public health officers and policy makers in confirming the safety profile of Rotarix™.   "
209561|NCT00585650|"     The purpose of this research study is to see how well (compared to placebo) Enbrel®     (etanercept) 50 mg twice a week affects plaque psoriasis of the hands and/or feet     (Palmoplantar Psoriasis)   "
209685|NCT00597194|"     We compare laparoscopic and classic open operation for inguinal hernia in children. Attention     is focused on the recovery, surgical result and the duration of the operation and hospital     stay.   "
209488|NCT00595088|"     This study is designed to assess the efficacy and safety of DTA-H19/PEI given as six     intravesical instillations of 20 mg of plasmid DNA complexed with PEI into the bladder of     patients with intermediate risk superficial bladder cancer [recurrent stages Ta (low or high     grade)and T1, (low grade) transitional cell carcinoma (TCC)] who have failed prior     intravesical therapies including either Bacillus Calmette-Guérin (BCG) or chemotherapy. The     primary efficacy objective is to determine the effect of DTA-H19/PEI on the prevention of new     tumors after the induction course of 6 weekly intravesical administrations of investigational     product assessed 8 to 10 weeks after the start of treatment. Secondary objectives include     assessing the ablative effect of DTA-H19/PEI on a marker tumor, safety assessed by the     incidence and severity of adverse events, determining the long-term (46 weeks) continued     rates of absence of bladder cancer, and time to tumor recurrence in those patients who had a     complete response (CR) after the induction course.   "
209489|NCT00595101|"     To investigate dose response, safety and efficacy of PF-03187207 in patients with primary     open-angle glaucoma or ocular hypertension   "
209490|NCT00595114|"     Chronic obstructive pulmonary disease (COPD) and asthma are common respiratory diseases in     which people experience long-term inflammation of the lungs. Exacerbations, or prolonged     worsening of symptoms, of asthma and COPD are often life-threatening and can lead to frequent     need for hospitalization. Even with the proper use of bronchodilators, corticosteroids, and     other currently available medications, clinical responses among people with COPD and asthma     are variable. There remains a significant unmet clinical need for new therapeutic approaches     and insights, including the identification of biomarkers to accurately assess the presence of     airway infection and intensity of airway inflammation. This study will investigate potential     natural biological causes and new biomarkers for increased susceptibility to persistent     airway infection in asthma and COPD.   "
209491|NCT00595127|"     The purpose of this research study is to: (1) determine if the combination of low dose total     body irradiation, low dose cyclophosphamide and the addition of fludarabine, and a serum to     suppress the immune system can allow selected stem cells to take and grow; (2) determine if     selected stem cells from the blood or marrow can take and not cause graft-versus-host disease     (GvHD), and; (3) evaluate the side effects of the combination of low dose radiation and     chemotherapy drugs used for these transplants.   "
209492|NCT00595140|"     The purpose of the study is to investigate the efficacy of an acute additional application of     the somatostatin analogue octreotide 100µg s.c. or the dopamine agonist cabergoline 0.5mg     p.o. to the receptor antagonist pegvisomant during a 6 or 9 hour profile on reducing     endogenous growth hormone in patients with acromegaly on stable pegvisomant therapy.   "
209493|NCT00595153|"     The purpose of this study is to identify the causes of asthma that were not previously     suspected, to better understand the effects of inhaled steroids on asthma and to identify new     way to treat asthma. In order to take advantage of the most current scientific expertise, we     (scientists at UCSF) plan to work together with Genentech Inc. We believe that working with     Genentech will provide the best chance of developing new treatments for asthma.   "
209494|NCT00595166|"     This new invention addresses the inadequate and incomplete visualization of the cervix in     patients with excessive vaginal tissue. In general these patients are obese, or are     multiparous with a history of multiple vaginal deliveries.      A vaginal speculum is a vital medical instrument that allows a health care provider to     visualize the interior aspects of the vagina, as well as the distal portion of the uterus,     the cervix. It is composed of 2 blades assembled together and held by a handle. The blades     and the handle form a 90 degree-angle. As the user holds the handle, a lever attached to the     top blade allows it to open away from the inferior blade.      When the instrument is inserted into the vagina, the two blades are separated in order to     keep the anterior and posterior vaginal walls apart. In that position, the cervix and the     walls of the vagina can be seen if the patient does not have an excess of loose vaginal     tissue. However, in patients with excessive tissue, the sidewalls of the vagina simply     collapse toward the midline between the blades because of the fact that no part of the     speculum is in direct contact with the lateral walls of the vagina. This collapse prevents     the complete and crucial visualization of the cervix for purposes of cervical cultures, pap     smears, visual assessment of ruptured membranes, visual assessment of the degree of dilation,     biopsies, and other procedures requiring access to the cervix or the uterus.      When clinicians face this dilemma, they may try the largest speculum available, and will open     it as wide as possible in order to keep the lateral walls apart. Most often, they have to     improvise by cutting the tip of a condom, or the thumb off a glove, or they use a sterile     lateral-wall retractor. These other creative solutions can take several minutes of precious     times and may still result in an inadequate visualization and suboptimal access.      A vaginal speculum sheath for retaining vaginal tissue in a lateral direction conforms to a     pair of blades that are movable between an opened position and a closed position. The blades     in the closed position are adapted for insertion into a vagina, and in the open position,     they allow dilating the vagina in order to provide access to the cervix.      This new design includes a flexible, transparent polyurethane sleeve structure that extends     between the blades when the speculum is opened. The stretched sheath is adapted to retain the     lateral walls of the vagina in the open position. The elastic sleeve is designed to remain in     a collapsed configuration when the blades are in a closed position to avoid interfering with     insertion or withdrawal of the speculum [Reference: U.S. patent 6432048 (2002-8-13)].     Polyurethane material is FDA approved for vaginal use.      The purpose of this study is to compare standard of care speculum vs. sheathed speculum in     the examination of patients with collapsing vaginal sidewalls during a gynecological speculum     exam.      The primary hypothesis testing for this study will be to compare the standard of care     speculum exam to a sheathed speculum exam in a prospective, randomized clinical trial.   "
209539|NCT00585364|"     The goal of this study is to identify the immunological factors that influence a patient's     response to the presence of the fungus Aspergillus fumigatus (A. fumigatus) in the lungs. In     patients with cystic fibrosis (CF), this fungus is not known to cause damage to the lungs,     but some patients respond with an allergic reaction that may cause wheeze, cough, or     difficulty breathing. Approximately 230 patients will be enrolled with an additional 60     people who do not have CF and who do not have a history of asthma to serve as a comparison     group.   "
209542|NCT00585403|"     The goal of this research is to determine how the peripheral immune system is altered by     exercise and differences related to gender, pubertal status and health.   "
209495|NCT00595179|"     Current assessment of organ tissue viability by surgeons in the operating room is limited to     crude estimates such as overt physical examination, measurement of laboratory values and     physical measurements of vascular flow and resistance. The ability to non-invasively measure     tissue perfusion and oxygenation would provide the surgeon an improved means to assess if an     injured organ will survive. The recent development of real time infrared (IR) and Near     Infrared Imaging Spectroscopy (NIRIS) digital cameras has allowed for the determination of     tissue perfusion and oxygenation in a non-invasive fashion. Although in the early stages of     development, the application of infrared and NIRS technology holds great promise to permit     the surgeon to better assess the viability of tissues in ways that have not been possible. We     propose to evaluate infrared and NIRS technology in the assessment of kidney allografts using     data previously collected during recipient operations at the NIH.   "
209686|NCT00597207|"     During resuscitation of out of hospital cardiac arrest patients the use of a mechanical chest     compression device Autopulse will improve survival compared to manual compressions.   "
209497|NCT00595218|"     Limited data exists for the cancer patients' preferences on their patient-doctor interaction     with their radiation oncologist. These physicians have the opportunity to develop intimate     relationships with their patients since these patients typically require daily radiation     treatments anywhere from one to seven weeks. Thus, by having a greater understanding of the     individual patient preferences, the radiation oncologists will be able to better serve their     patients leading to improved patient satisfaction with their physician and healthier outlook     on life. This is the premise and the hypothesis of this study.   "
209498|NCT00595231|"     This is an eight week, randomized, double blind, placebo-controlled, exploratory study.     Patients randomized to rufinamide (SYN111) will receive 250 mg BID (total daily dose 500mg)     for one week then have their dose increased to 500 mg BID (total daily dose 1000mg) for the     remaining 7 weeks of the study. If the 500 mg BID dose is not tolerated, one dose reduction     is allowed.   "
209499|NCT00595244|"     This trial is to compare PB127 echocardiography to other heart imaging studies.   "
209500|NCT00595257|"     The purpose of this study is to determine if concentrated nucleated cells from your own bone     marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to     avoid amputation.   "
209501|NCT00595270|"     The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and     the need of a booster dose   "
209502|NCT00595283|"     This study will evaluate the effectiveness of parent-child interaction therapy that includes     an emotion development component in treating depression in preschool children.   "
209503|NCT00595296|"     This post-approval study is designed to determine the performance of the FDA-approved     GeneSearch™ BLN Assay when compared to the site's standard of care permanent section     histological evaluation, and when compared to more extensive histological evaluation when the     assay is being used by clinicians to make surgical decisions on complete axillary dissections     (ALND).   "
209504|NCT00595309|"     The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in     terms of seroconversion rate.   "
209505|NCT00595322|"     This is a pilot study. The goal of this study is to test whether Bevacizumab is safe enough     in patients with brain tumors so that a larger study can be conducted. This study will also     give us some information about whether the combination of Bevacizumab and radiation has     potential to become an effective treatment for regrowing brain tumors.      Bevacizumab is an experimental drug that blocks a molecule called VEGF that is found in high     amounts in malignant gliomas. VEGF promotes the growth of blood vessels that bring nutrients     to tumor cells. In studies with laboratory animals, Bevacizumab slowed the growth of several     different types of human cancer cells by blocking the effects of VEGF. There is also evidence     that Bevacizumab enhances the effects of radiation on tumor cell   "
209506|NCT00595335|"     This study is being done to investigate the effects (good and bad) of Rituximab for the     treatment of an autoimmune eye disease called Graves' ophthalmopathy. This disease has proven     to be difficult to treat. Rituximab is a monoclonal antibody that depletes a line of cells     involved in the autoimmune response. The study hypotheses is that rituximab is effective in     the treatment of patients with moderate to severe active Graves' ophthalmopathy.   "
209507|NCT00595348|"     1. To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients with family          history of breast/ovarian cancer.        2. To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients without family          history, but high risk of hereditary cancer.        3. To evaluate the prevalence of BRCA1/2 mutation of family member of BRCA1/2 mutation.        4. To evaluate the prevalence of ovarian cancer of population of above 3 groups.   "
209508|NCT00595361|"     The purpose of the study is to find out how well a long-acting beta agonist like salmeterol     works in people with different forms of the same gene. Our hypothesis is that asthmatics with     the Arg/Arg genotype will have loss of bronchoprotection against exercise-induced asthma with     regular salmeterol treatment, as compared to asthmatics with the Gly/Gly genotype.   "
209509|NCT00595374|"     This trial is conducted in Europe.      The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin     NPH in adults with type 1 diabetes on blood glucose control.   "
209510|NCT00595387|"     This study will compare the effectiveness of cognitive behavioral therapy versus supportive     psychotherapy in decreasing depression in people with bipolar disorder.   "
209511|NCT00595413|"     The primary objective of this study is to evaluate the efficacy of atacicept compared to     placebo in the treatment of signs and symptoms in a subject population with active rheumatoid     arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to     anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.   "
209512|NCT00595426|"     To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in     subjects undergoing primary elective knee replacement surgery   "
209543|NCT00585416|"     The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with     metastatic hormone refractory prostate cancer as measured by changes in PSA.   "
209525|NCT00595608|"     Patients undergoing nasal surgery commonly experience a variety of symptoms in the     post-operative period including blockage, running, pain, bleeding and reduction in sense of     smell. A variety of preparations are currently recommended for symptomatic relief in the post     operative period. These include saline irrigations and sniffs, steam inhalations,     decongestants and steroid drops.      There is currently no level 1 evidence in literature to support the use of any particular     preparation over others in nasal surgical aftercare.      We propose to conduct a single blinded, randomised trial comparing saline sprays vs Sterimar,     a commercially available aerosolised isotone saline solution, comparing patients' symptom     scores following septal surgery.      The trial will help to establish efficacy and symptom control and advantages of one solution     and delivery device over the other.   "
209526|NCT00595621|"     Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the     treatment of patients with severe diabetic gastroparesis refractory to standard therapy.   "
209573|NCT00585819|"     The overall, broad objective of this study is to pilot the BSD technique. The specific     purpose of this particular study is to generate pilot data to validate several crucial steps     of the BSD technique, in particular steps 1, 2, and 4. Radiation treatments will proceed per     standard of care, and will not be modified in any way during this protocol. This study is a     non-treatment protocol.   "
209513|NCT00595439|"     This study will investigate differences among people with focal dystonia (FD), complex     regional pain syndrome (CRPS) and people who have both conditions to learn more about the     cause of both disorders.      Participants undergo the following procedures in five visits:        -  Electroencephalography (EEG). Electrodes (metal discs) are placed on the scalp with an          electrode cap, a paste or a glue-like substance. The spaces between the electrodes and          the scalp are filled with a gel that conducts electrical activity. Brain waves are          recorded while the subject lies quietly and sensory stimulation is applied to the thumb          or finger.        -  Magnetic resonance imaging (MRI). This test uses a magnetic field and radio waves to          obtain images of body tissues and organs. The patient lies on a table that can slide in          and out of the scanner, wearing earplugs to muffle loud knocking and thumping sounds          that occur during the scanning process. The procedure lasts about 45 minutes, during          which time the patient will be asked to lie still for up to 15 minutes at a time.        -  Transcranial magnetic stimulation (TMS). An insulated wire coil is placed on the scalp          and a brief electrical current is passed through the coil. The current induces a          magnetic field that stimulates the brain. There may be a pulling sensation on the skin          under the coil and a twitch in muscles of the face, arm or leg. During the stimulation,          subjects may be asked to keep their hands relaxed or to contract certain muscles.        -  Peripheral electrical stimulation. In two experiments, TMS is combined with peripheral          electrical stimulation, similar to what is used in nerve conduction studies, to the          median nerve at the wrist. There may be muscle twitching.        -  Surface electromyography. For TMS tests and peripheral electrical stimulation,          electrodes are filled with a conductive gel and taped to the skin to record the          electrical activity of three muscles on the right hand.        -  Needle EMG. A needle is inserted into a muscle to record the electrical activity.        -  Nerve conduction studies. A probe is placed on the skin to deliver a small electrical          stimulus, and wires are taped to the skin record the nerve impulses. These studies          measure the speed with which nerves conduct electrical impulses and the strength of the          connection between the nerve and the muscles.        -  Skin biopsy. Two sites are biopsied. A local anesthetic is given to numb the area and a          1/4-inch piece of skin is removed with a special tool.        -  JVP domes. Subjects are tested for their ability to discriminate sensory stimuli in the          affected region and on the other side of it. They are asked to discriminate between          stamps with grooves of different widths that are applied to the hands or feet.   "
209514|NCT00595465|"     The objective is to demonstrate equivalence of three commercial IC51 batches in terms of     geometric mean titers for anti-JEV neutralizing antibody   "
209515|NCT00595478|"     The goal is to adapt the family-based CM treatment to target primary adolescent alcohol abuse     and dependence.      Specific Aim 1 is to provide a preliminary demonstration of the efficacy of a family-based CM     intervention to treat adolescent alcohol abuse and dependence. CM components include:        1. an incentive program to enhance the adolescent's engagement in the treatment process and          engender alcohol abstinence by providing positive reinforcement for documented          abstinence via breathalyzers administered by parents regularly at home, self and parent          report, and clinic-based urine drug testing; and        2. a parent management training program to enhance and maintain the positive effects of the          incentive program by teaching parents how to effectively use contingency management in          the home environment to motivate their adolescent to achieve abstinence and improve          their behavior in other domains.      A randomized trial will determine whether the CM intervention enhances outcomes when added to     a standard individual cognitive behavioral therapy (CBT).      Specific Aim 2 is to determine whether and how treatment interventions modify parental and     adolescent risk and protective factors using observational and laboratory measures (parenting     practices, family functioning, risk taking, delay discounting, and child and parent     psychopathology) and to determine whether these factors are associated with outcomes over     time.      Specific Aim 3 is to test gene x environment (treatment) interactions in adolescent substance     abuse. Findings will extend the scientific evidence for CM and support the ability of parents     to implement CM at home. Findings that support the CM model's efficacy will make a     significant contribution to research on the treatment of adolescent alcohol abuse, which has     lagged behind research on adult substance abuse and on adolescent illicit drug use.   "
209516|NCT00595491|"     Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways     contribute to airway obstruction. The biological basis for airway inflammation is the subject     of intensive investigation. This work is designed to identify airway factors that are     responsible for recruiting cells and associate their airway presence with atopy and asthma.   "
209517|NCT00595504|"     This study involves people who have schizophrenia or schizoaffective disorder who are     currently taking antipsychotic medications. Some antipsychotic medications may cause weight     gain and may increase the risk of diabetes mellitus and heart disease.The purpose of this     study is to find out what happens if another medication (ramelteon) is used along with your     antipsychotic medication. We want to find out whether doing this will:        -  Change the way your body breaks down fat and sugar.        -  Affect your waist size, stomach fat and triglycerides (a type of fat in your blood).        -  Improve how your body responds to insulin.        -  Affect your quality of sleep.        -  Reduce movement disturbances Ramelteon is approved by the U.S. Food and Drug          Administration (FDA) to treat people that have difficulty falling asleep. It is not          approved for such things as affecting waist size or improving how the body breaks down          fat and sugar. Its use in this study is investigational.   "
209518|NCT00595517|"     The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20     mg once daily for up to 52 weeks of treatment involving patients with a history of gastric     and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by     evaluating AE, clinical laboratory value and vital signs.   "
209519|NCT00595530|"     Acute pain episodes associated with sickle cell disease (SCD) are very difficult to manage     effectively. Opioid tolerance and side effects have been major roadblocks in our ability to     provide these patients with adequate pain relief. This pilot study is designed to examine the     safety and feasibility of using ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist,     in the inpatient seeing with children and adolescents who have sickle cell vasoocclusive     pain. Previous research suggests that in subanesthetic doses, ketamine may be able to prevent     the development of opiate tolerance and facilitate better pain relief with lower opiate     doses, allowing for less respiratory depression, less sedation, easier ambulation, less     deconditioning, shorter hospital stays, and better quality of life. The goal of this pilot     study is to evaluate the safety and feasibility of using a continuous infusion of ketamine,     in conjunction with opiates, in the inpatient setting for sickle cell vasoocclusive pain. It     is hypothesized that using a low dose ketamine infusion in conjunction with opiates will be a     safe and feasible practice for the treatment of sickle cell pain.   "
209520|NCT00595543|"     To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5%     ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.   "
209521|NCT00595556|"     This is a pilot study designed to examine the potential efficacy and tolerability of     zonisamide compared to placebo for the treatment of alcohol dependence.   "
209522|NCT00595569|"     To prospectively evaluate the long term metabolic and psychological effects of flexible     intensive insulin therapy (FIT) courses in an unselected population of type 1 diabetic     patients at the University of Basel Hospital. We hypothesize that both metabolic control and     psychological parameters will improve.   "
209523|NCT00595582|"     This is an additional study to the primary Mild Cognitive Impairment (MCI) study     (LSU#H04-049; NCT00243451)that is underway of PET detection of Mild Cognitive Impairment.     This study has preliminary data that indicates objective analysis of PET brain image     metabolic data is a sensitive marker for AD. The goal of this proposal is to determine the     efficacy of curcumin in the treatment of MCI or mild Alzheimer's Disease (AD).   "
209527|NCT00595634|"     The primary objective of this study is to characterize patients' course of recovery in the     year following the initial surgery for unstable intertrochanteric hip fractures treated with     the InterTAN intramedullary hip screw device. This will be done by collecting patient outcome     measures of health related quality of life and functional status including return to normal     gait. Secondary objectives are to document any adverse events associated with the procedure,     and to analyze differences in recovery due to differences in age, gender, co-morbidities,     nutrition, residence and ambulation status, and use of mobility aids.   "
209528|NCT00595647|"     Prospective multicenter controlled randomized trial to compare the safety and efficacy of     drug eluting vs. bare metal stents in percutaneous coronary interventions of saphenous vein     grafts. Hypothesis: Survival and outcome will be significantly better in patients receiving     DES than in patients receiving BMS regarding both short-term and long-term outcome.   "
209529|NCT00595660|"     Needle size from22 to 25 were used for fine needle aspiration of palpable breast lumps. In     this study we choose one, randomly, and fallow the result of cytologic evaluation regarding     specimen adequacy.   "
209530|NCT00595673|"     This trial is to compare PB127 echocardiography to other heart imaging studies.   "
209531|NCT00595686|"     Hsp90 is a chemical in the body that is involved in the promotion of cancer. SNX-5422 is an     experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in     patients with cancer.   "
209532|NCT00595699|"     This is a research study evaluating the use of escitalopram (Lexapro®) for the treatment of     major depression in subjects with temporal lobe epilepsy. The purpose of the study is to     measure the severity and change in depressive and anxiety symptoms after 10 weeks of study     treatment with escitalopram or placebo as measured by certain rating scales and     questionnaires. In addition, the study will measure the frequency of seizures using a patient     diary during the study. Finally, the study will assess the change in the quality of life     using rating scales.   "
209533|NCT00595712|"     The purpose of this RCT is to determine the results of opening-wedge high tibial osteotomy in     patients with genovarum deformity using iliac crest allograft compared to the results when     using iliac crest autograft.   "
209534|NCT00595725|"     The purpose of this study is to learn if a surgical technique called intraoperative lymphatic     mapping can accurately identify the lymph node that is at greatest risk if endometrial or     cervical cancer spreads to the lymph nodes.      Early cervical cancer is usually treated by removing the cervix, tissue around the cervix,     and the upper vagina. If needed, the uterus is also removed. The treatment also includes     removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the     cervix, uterus, fallopian tubes and ovaries.      The treatment also includes removing lymph nodes from the pelvis.   "
209535|NCT00595738|"     The relationship between peripheral venous saturation and central hemodynamics (including     right and left heart filling pressures and cardiac output), mixed venous oxygen saturation,     and contemporary biomarkers of heart failure is not clear. We aim to determine the     relationship between mixed venous, central venous, and peripheral venous oxygen saturation in     patients with advanced (class III or IV) heart failure. We will determine the relationship     between cardiac output measured via thermodilution and the Fick equation calculated using     concurrent oxygen saturations from the distal PA, central vein, and peripheral vein. We also     aim to examine the relationship of selected cardiac biomarkers with cardiac filling pressures     and cardiac output over time in patients with decompensated heart failure.   "
209536|NCT00595751|"     The study will evaluate the effectiveness of a standardized EEG method with the intended     clinical users in the intended clinical settings with the intended population (patients who     would typically receive a clinician's evaluation for ADHD). Multiple sites will be examined     to provide a sample of patients across numerous communities with different demographics. The     goal is to evaluate if the predictive accuracy of EEG will not be inferior to that of a     widely-used and extensively validated ADHD scale in the prediction of ADHD in the intended     use population as evaluated by Best Estimate Diagnosis.   "
209537|NCT00585338|"     Dermatologists have for many years treated vascular lesions by a variety of modalities     including cryosurgery, electrotherapy, dermabrasion and radiation.      It has been hypothesized that simultaneous delivery of these two wavelengths may provide     safer, and in some cases more effective, vascular lesion removal.      The Tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple     532/1064 nm laser pulses.This mode may reduce malformed blood vessels with a low incidence of     long-term side effects.   "
209538|NCT00585351|"     We are inviting patients who have been diagnosed with an ischemic or hemorrhagic stroke and     are being transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics     (UIHC) for further care to participate in this research study to test the following: 1) To     test whether it is possible to go through all the procedures necessary to start a study,     including an informed consent, before the patient is transferred by helicopter to Iowa City.     2)To test a low risk medication called, Ranitidine, that might lower the chances of     developing chemical pneumonitis (irritation of the lungs by stomach contents), a fairly     common complication in patients that have had a stroke. Patients will be randomly assigned to     receive a single dose injection of either Ranitidine (50 milligrams (mg)) or placebo (normal     saline).   "
209544|NCT00585429|"     A non-invasive urinary test that detects kidney injuries in liver transplant (LT) candidates     would be useful for monitoring of kidney damage. Particularly, the ability to predict     irreversibility of such renal damage or progressive nature of renal disease in LT candidates     would be of importance to determine the need for dual kidney-liver transplantation (KLT)     versus LT alone. We will correlate kidney histology with cytokine/chemokine profile     expression in the urine as a potentially useful noninvasive diagnostic tool.   "
209559|NCT00585624|"     We are proposing to evaluate the benefit of preoperative nutritional support with Impact     Advanced Recovery in the most vulnerable group of elective gastrointestinal surgery patients     who may experience a complication, esophagus and pancreas resections, and hypothesize that     oral supplementation with 3 servings (0.75 L) Impact Advanced Recovery will reduce     postoperative stay by 10-20% and reduce the incidence of major complications by 25%.   "
209695|NCT00597324|"     The study will evaluate the feasibility and safety of radial approach in patients undergoing     coronary catheterisation without any restrictions based on the results of Allen's test.   "
209545|NCT00585442|"     The cardiovascular effects of vitamin D therapy (in humans) have been documented only in     patients with known vitamin D deficiency or hyperparathyroidism (a surrogate marker of     inadequate vitamin D activity). It is unknown whether the cardiovascular benefits of vitamin     D therapy extend beyond these patients to the general hypertensive population. We propose to     directly measure the effect of vitamin D therapy on plasma renin activity (PRA), plasma renin     concentration (PRC), renin transcription (in mononuclear leukocytes), and blood pressure in     hypertensive (but otherwise healthy) patients in a randomized, controlled, experimental     trial. This will be the first study to assess vitamin D receptor (VDR) biological (PRA, PRC,     renin mRNA, and polymorphisms) and hypertensive activity in patients without vitamin D     deficiency. We hypothesize that vitamin D inhibition of renin transcription will produce     significant reductions in PRA, PRC, renin transcription, inflammatory cytokines, SBP, and     DBP, with potential variation by VDR genotype. Such a result may prove to be significant in     the treatment of hypertension, as even modest blood pressure reductions (5 mmHg) are     associated with a 14% reduction in mortality due to stroke, a 9% reduction in mortality due     to CHD, and a 7% overall reduction in all-cause mortality.   "
209546|NCT00585455|"     To determine the effects of chronic sertraline treatment on brachial artery flow-mediated     dilation in patients with chronic heart failure and depression   "
209547|NCT00585468|"     Literature regarding the effect of food on the pharmacokinetic (PK) profile of enteric-coated     mycophenolate sodium combined with tacrolimus and corticosteroid withdrawal is lacking. The     objective of this study is to identify pharmacokinetic variables of mycophenolate sodium     (Myfortic®) in the fed and fasting state in stable renal transplant patients on tacrolimus in     combination with a rapid steroid withdrawal protocol.   "
209548|NCT00585481|"     The primary objective of this study is to determine the incidence of severe RSV LRTI     requiring hospitalization among infants born < 35 weeks gestational age for one year of     follow-up.   "
209549|NCT00585494|"     This protocol will determine the prevalence of hyperglycemia and diabetes in the elective     orthopedic population at the University of Wisconsin. It will also determine if there is a     difference in outcomes. The study hypothesizes that at least 10% of patients will have some     degree of impaired glucose regulation that has previously been undiagnosed.   "
209550|NCT00585507|"     Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic     breast cancer. The dose used in studies so far has been well tolerated and may be too low for     optimal effectiveness. In this study, a higher dose will be used to see whether an improved     outcome will result.   "
209551|NCT00585520|"     Cocaine dependence is a chronic, relapsing disorder in which stress/negative mood and     exposure to drug-related stimuli or cues are associated with high rates of relapse (McKay     et al., 1995; O'Brien et al., 1998; R. Sinha, 2001; Shaham et al., 2003). In particular, sex     differences in relapse precipitants have been noted, with women reporting greater stress     related relapses while men report higher number of relapses associated with drug     cue/temptation situations (Lex, 1991; McKay et al., 1996; R. Sinha, 2001; R. Sinha,     Rounsaville BJ, 2002). Current SCOR studies have shown that stress and cocaine cues increase     drug craving and stress related arousal, responses that differ in cocaine men and women (R.     Sinha et al., 2003; H.C. Fox et al., 2005a). Furthermore, stress-induced cocaine craving and     HPA responses are predictive of cocaine relapse, which is also moderated by gender (R. Sinha     et al., 2006). However, no previous research has examined the basis of sex differences in     stress and cue induced craving and arousal, both of which are known to increase relapse     susceptibility. Greater knowledge of the sex-specific neurobiology of cocaine dependence will     facilitate development of gender-specific cocaine relapse prevention efforts.      Growing evidence supports a role for gonadal hormones in explaining the sex differences     observed in stress responses as well as in the behavioral responses to cocaine (Festa &     Quinones-Jenab, 2004; K. Carroll, Fenton LR, Ball SA, Nich C, Frankforter TL, Shi J,     Rounsaville BJ, 2004; Lynch, 2006; Kajanti & Phillips, 2006). Estrogen increases behavioral     responses to cocaine, while presence of progesterone decreases subjective and behavioral     effects of cocaine, more so in females than males (Jackson et al., 2006; Sofuogu et al.,     1999; M. Sofuoglu et al., 2002; Evans & Foltin, 2006). Stress and cocaine each enhance brain     stress circuits, namely the corticotrophin releasing factor     (CRF)-hypothalamic-pituitary-adrenal (HPA) axis and central     noradrenergic/sympatho-adrenomedullary (SAM) pathways and both activate the mesolimbic     dopaminergic systems involved in the rewarding effects of cocaine (ADD REFS). Exposure to     Stress, cocaine or cocaine cues will each increase cocaine craving and HPA axis responses.     Importantly, progesterone which affects behavioral responses to cocaine, also plays a key     role in stress regulation. However, it is not known whether progesterone alters     stress-induced and drug cue-induced craving and related stress arousal, markers that predict     cocaine relapse outcomes. Our preliminary data suggest that women exposed to stress and to     drug cues in the laboratory during the luteal phase (high progesterone) show lower stress     induced and drug cue-induced craving, anxiety and cortisol responses compared to those in the     late follicular phase (high estrogen) (see preliminary Studies section CX). On the basis of     this previous research, we propose a double-blind placebo controlled study of to examine     progesterone's effects on stress and cue-related responses in cocaine dependent men and     women. We hypothesize that high dose of progesterone (200 mg bid) vs. placebo will alter     stress-induced cocaine craving, negative affect, physiological and HPA responses to stress,     and these changes will be greater in women than men.   "
209552|NCT00585533|"     This study will evaluate Tarceva in a selected population of patients with untreated advanced     non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis     based on clinical criteria. It is anticipated that selection will enrich for tumor     characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater     than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for     patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at     some point in the future and may prolong the time to chemotherapy related progression.      Patients will remain on study until disease progresses, a decline in performance status, if     patient cannot tolerate the side effects or develops symptoms requiring conventional     chemotherapy.   "
209553|NCT00585546|"     The purpose of this study is to evaluate whether patients with chronic heart failure not due     to coronary artery disease who require use of a left ventricular assist device (LVAD) for     refractory heart failure can recover sufficient heart function to allow the pump to be     explanted. The study aims to avoid the need for transplantation in these patients by using     standard heart failure medications to reduce the size of the left ventricle and then using     the investigational drug, clenbuterol, to further improve left ventricular function.   "
209554|NCT00585559|"     The objective of this study is to determine whether acetaminophen (APAP), N-acetylcysteine     (NAC), and APAP in combination with NAC will inhibit lipid peroxidation in aneurysmal     subarachnoid hemorrhage (aSAH), utilizing F2-IsoPs as biomarkers for lipid peroxidation.   "
209555|NCT00585572|"     The Wisconsin Brain Donor Program (WBDP) stores brain and other tissues/samples (e.g. blood     and CSF) from deceased individuals who have participated in longitudinal research studies, as     well as other select participants. These individuals have donated their tissues in order to     aid scientific research. Through the collection of central and peripheral nervous tissues as     well as (in select cases) skeletal muscle tissue, the WBDP strives to advance the knowledge     of diseases of memory disorders, such as Alzheimer's Disease. Brain donations are needed from     healthy individuals, as well as those affected by diseases of the nervous system.   "
209556|NCT00585585|"     The purpose of this study is to determine a dose of the investigational drug betahistine     dihydrochloride that is both well tolerated and potentially effective in treating the     symptoms of atypical depression. Atypical depression is characterized by the ability of the     person's mood to improve temporarily in response to positive events, as well as features such     as increased appetite, increased sleep and severe fatigue.   "
209557|NCT00585598|"     In the trauma setting, if a patient has arrived in the trauma bay with an ETC/King LT-D in     place, it has traditionally been immediately exchanged out for an ETT upon arrival. The     timing of the exchange has never been adequately defined in terms of safety. This study is a     prospective clinical trial designed to evaluate the safety of supralaryngeal, ETC/King LT-D     tube, exchange [either in the operating room (if immediate surgery is required) or after     stabilization in the trauma bay/intensive care unit according to the protocol adapted     previously by UWHC.   "
209766|NCT00598286|"     The purpose of this protocol is to measure brain CB1 receptors in the hope to better     understand how they work, so that one day we can understand how the CB1 receptors are     involved in psychiatric, neurological, and behavioral disorders.   "
209558|NCT00585611|"     The study is designed to define the underlying vascular abnormalities present in patients     with diastolic heart failure and test the effect of a therapy aimed at vascular     abnormalities. This study is designed to investigate the effects of therapy with atorvastatin     in subjects with diastolic heart failure to improve abnormalities of vascular and myocardial     structure and function, with particular emphasis on arterial stiffness and endothelial     dysfunction.   "
209562|NCT00585676|"     It is known that administration of steroids increases blood sugar levels. Administration of     betamethasone is common practice during pregnancy to women at risk for preterm delivery.     However, it is unknown the magnitude of the changes in glucose these women have after     receiving betamethasone. The purpose of this study is to determine the magnitude and timing     of the increase in blood sugar in pregnant women without diabetes who receive steroids.   "
209563|NCT00585689|"     Study participants will have been diagnosed with bladder cancer that has invaded the muscle     wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the     bladder. Unfortunately, approximately 50% of people may have their cancer return in another     location. For this reason, researchers are focusing on new chemotherapy regimens to be given     before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading.      Paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder     cancer cells.      ABI-007 (brand name Abraxane™) is a form of the chemotherapy drug called paclitaxel. Standard     paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated     castor oil). However, these additives are felt to contribute to the side effects (possibly     severe) associated with paclitaxel. ABI-007 does not contain these additives and may deliver     more drug to tumor cells. ABI-007 is approved by the United States Food and Drug     Administration (FDA) in the treatment of metastatic (advanced) breast cancer, and is being     evaluated in other cancers in research studies.      This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin     and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.   "
209564|NCT00585702|"     The purpose of this study is to learn about the effects of bipolar disorder or the use of     antimanic medications on the mother's health and wellbeing during pregnancy and for the first     postpartum year. Infant health and development are also assessed during the first year.     Participation in the study includes 7 study visits, three in pregnancy and four postpartum.   "
209565|NCT00585715|"     The purpose of this research study is to evaluate effectiveness of a non-ablative (does not     remove skin) treatment for cellulite (dimpled fat) in conjunction with skin tightening using     the Candela GentleYAG laser.   "
209566|NCT00585728|"     The purpose of this study is to see how CT virtual proctoscopy compares to an ultrasound exam     of the rectal area in determining the stage of rectal cancer for people recently diagnosed     with rectal cancer. This study will also compare tumor volume before and after neoadjuvant     therapy using CT virtual proctoscopy, with the ultrasound exam as a comparison. Neoadjuvant     therapy consists of chemotherapy and radiation therapy. Neoadjuvant chemoradiation therapy is     done before surgery to reduce the size of tumors.   "
209567|NCT00585741|"     Fractionated radiotherapy induces an observable change in the proliferative activity as     assessed by pre-treatment and early-treatment 18F-FLT PET imaging. This study is designed to     investigate 18F-FLT as a PET imaging agent for predicting treatment effectiveness in several     tumors and will serve as a pilot study to a planned PO1 submission   "
209568|NCT00585754|"     This study aims to test the preliminary efficacy of 3.0 mg of guanfacine (GFC) daily versus     placebo in cocaine and/or alcohol dependent individuals. This proposal is a laboratory and     treatment outcome study to examine the effects of guanfacine on brief exposure to stress,     drug cues and neutral situations on cocaine/alcohol craving, mood and neurobiological     reactivity in a sample of cocaine and/or alcohol dependent individuals. Guanfacine will be     beneficial for reduction in stress and drug cue induced craving and related arousal. In a     sample of 60 cocaine and/or alcohol dependent men and women, we propose to examine (a)     differences in measures of cocaine craving, emotion state, hypothalamic-pituitary-adrenal     (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery     and to drug cue imagery as compared to neutral imagery; (b) reduction in cocaine/alcohol     abstinence symptoms; and (c) improvement in cocaine and alcohol treatment outcomes as     measured by increasing abstinence, reduction in cocaine/alcohol use and increased treatment     attendance. Hypothesis 1: Guanfacine will decrease stress-induced cocaine craving, negative     emotions and related arousal in the laboratory as compared to placebo. Hypothesis 2a: As     compared to the PLA group, the GFC group will show significant reductions in protracted     withdrawal symptoms as measured by the CSSA/CIWA during the 9-week treatment period.      Hypothesis 2b: As compared to the PLA group, a higher percentage of the GFC patients will     remain abstinent during the 9-week treatment period with a higher percent of negative cocaine     urines and alcohol-free days.      Hypothesis 2c: The GFC group will show greater adherence to treatment as measured by the days     in treatment as compared to the Pla group.   "
209569|NCT00585767|"     This is a clinical feasibility study to assess the value of MR imaging for obtaining     functional, dynamic and anatomical information in a comprehensive imaging protocol in     subjects having obstructive uropathy.   "
209829|NCT00599131|"     The purpose of this study is to learn how to identify early which patients will respond to     chemotherapy plus radiation therapy in order to reduce the number of subjects who require     surgery (followed by radiation therapy).   "
209570|NCT00585780|"     To test the preliminary efficacy of 16.0 mg of Prazosin daily versus placebo in treatment     seeking alcohol dependent individuals. This proposal is a laboratory and treatment outcome     study to examine the effects of Prazosin on brief exposure to stress, drug cues and neutral     situations on alcohol and drug craving, mood and neurobiological reactivity in a sample of     cocaine and/or alcohol dependent individuals. Prazosin will be beneficial for reduction in     stress and drug cue induced craving and related arousal. In a sample of 120 alcohol dependent     men and women, we propose to examine (a) differences in measures of cocaine craving, emotion     state, hypothalamic-pituitary-adrenal (HPA) activation, physiological arousal and plasma     catecholamine response to stress imagery and to drug cue imagery as compared to neutral     imagery; (b) reduction in alcohol abstinence symptoms; and (c) improvement in alcohol     treatment outcomes as measured by increasing abstinence, reduction in alcohol use, increased     treatment attendance and decreased relapse risk.   "
209571|NCT00585793|"     Does subtype of HIV-1 affect the response of ARVs given to Ugandan children   "
209572|NCT00585806|"     This study will compare the ability of the heart to increase its contractile performance     during stress in patients with a history of heart failure without systolic dysfunction and in     controls.   "
209696|NCT00597337|"     This study will evaluate the effectiveness of a virtual learning treatment in reducing     bullying among primary school children in the UK and Germany.   "
209575|NCT00585845|"     This clinical trial will evaluate the safety and tolerability of CRS 207 an investigational     product that is a weakened form (attenuated) of Listeria monocytogenes, a type of bacteria     that is commonly found in the environment. CRS-207 has been altered in the lab to reduce its     ability to cause disease, while maintaining stimulation of the immune system. CRS 207 has     also been genetically modified with recombinant DNA to release an antigen called Mesothelin.     Because CRS 207 stimulates an immune response to Mesothelin and Mesothelin may be present at     higher levels on tumor cells than on normal cells, this clinical trial will also examine if     CRS 207 boosts the immune system in a way that targets certain types of cancer.      The purpose of this first clinical trial with CRS-207 is to identify an appropriate dose of     the investigation agent for later clinical studies and to explore safety when given to     consenting adults with advanced cancer of the ovary or pancreas, non-small cell lung cancer,     or advanced malignant epithelial mesothelioma. Immunological response to CRS-207 and tumor     status of study participants will also be measured. Patients who choose to enter the study     must meet all study entry criteria and must have previously failed standard treatment for     their cancer. Qualifying study patients will be assigned to receive one of several dose     levels of CRS-207. Each patient may receive up to 4 intravenous administrations (21 days     apart) of CRS-207 at their assigned dose level.   "
209576|NCT00585858|"     The purpose of this pilot study is to determine if there is clinical correlation between the     CKT and transplant recipients who are known to be on minimal or no immunosuppression     (presumed tolerant) and those who are on conventional amounts of immunosuppression and have     either experienced rejection (presumed hyper-responsive to donor) or have not experienced     rejection (unknown responsive state).   "
209577|NCT00585871|"     Cardiac arrest or sustained VT (ventricular tachycardia) in patients with heart disease is     best treated with an ICD (implantable cardioverter defibrillator). However, the ICD alone is     not appropriate therapy for patients with frequent VT episodes. In fact frequent shocks for     VT may predict a poorer prognosis. Anti-arrhythmic drugs are co-administered with ICDs in up     to 50% of patients to prevent VT episodes, but antiarrhythmic drugs may have harmful effects.     Thus improved drugs to prevent VT without interfering with ICD function are needed. Recent     data including our own suggest that clonidine may be a new therapy to prevent ICD shocks. It     may act centrally on sympathetic outflow and peripherally and selectively on cardiac     Purkinje, to suppress and control VT occurring in patients. Our purpose is to test the     hypothesis that clonidine reduces frequent VT better than beta blocker in patients with ICDs.     After informed consent patients will be randomized in a single blind fashion to either     clonidine or metoprolol given three times per day. Other prescribed drugs may be adjusted to     promote toleration of the study drug. ICD interrogations of episodes of VT will be the     primary endpoint. Device based NIPS (non-invasive programmed stimulation) testing in a subset     of these patients will allow mechanistic understanding of the clonidine effect. All of the     procedural techniques are in place as performed clinically; preliminary data are given     showing feasibility of the project.   "
209578|NCT00585884|"     Following placement of silicone breast prosthetics for reconstruction   "
209579|NCT00585897|"     Purpose The purpose of this study is to investigate the effects of discontinuation of sugar     sweetened beverages on hemoglobin A1c (HbA1c) and plasma fasting and post-prandial blood     glucose in a population with type 2 diabetes.      Hypothesis Elimination of sugar sweetened beverages from the diet for a 4 week period will     lead to a decrease in HbA1c and plasma fasting and 2 hour post prandial blood glucose in a     population with a history of type 2 diabetes and high consumption of sugar sweetened     beverages.      Specific aims to test hypothesis        1. Investigate how elimination of sugar sweetened beverages from the diet affects HbA1c and          plasma fasting and two hour post prandial blood glucose.        2. Test the feasibility of carrying out a simple diet intervention in an outpatient          population with type 2 diabetes.   "
209580|NCT00585910|"     The purpose of this study is to evaluate the safety, effectiveness, and tolerability of     atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children     and adolescents ages 6-17.   "
209581|NCT00585923|"     The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior     Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.   "
209582|NCT00585936|"     The purpose of this study is to determine whether magnetic resonance imaging (MRI) with     ferumoxtran-10 can be used to detect changes in the pancreas associated with autoimmune     diabetes.   "
209583|NCT00585949|"     This study will help to permit the development of preventative strategies as well as     cell-cased therapy for existent disease. It is hypothesized that aging is associated with     reduced vascular injury-induced endothelial progenitor cell activity, resulting in impaired     vascular repair and increased vascular disease. Patients with stable coronary artery disease     and a control group of patients undergoing coronary angiography without angioplasty will be     recruited.   "
209584|NCT00585962|"     The primary purpose of this study is to determine if high doses of radiation using proton     beam can be given safely with low and acceptable side effects. This study will also gather     data to determine the ability of the proton beam to eradicate prostate cancer. Proton beam     radiation is a very accurate kind of treatment that has been shown to affect less normal     tissue than a regular radiation beam.   "
209585|NCT00585975|"     This is a safety and efficacy study of bromfenac ophthalmic solution   "
209586|NCT00585988|"     The primary purpose of this study is to compare early functional outcomes in patients     undergoing hip resurfacing and total hip arthroplasty with the M2a-Magnum™ using more     objective measures of function.   "
209587|NCT00586001|"     The purpose of this study is to develop a new psychological therapy for a variety of     different types of emotional disorders. The study will compare symptoms and functioning of     clients who receive the treatment with those who do not, and will include a number of     assessments before, during, and after treatment. We predict that patients receiving active     treatment will show improved functioning relative to wait-list control.   "
209603|NCT00586222|"     This study is being done to detect the metabolic changes that Omega 3 fatty acid treatment     has on the brain and to find out whether magnetic resonance spectroscopy (MRS) scan can     detect metabolic differences between bipolar patients and healthy control participants.   "
209697|NCT00597350|"     The purpose of this study is to determine if bread containing fenugreek reduces blood sugar     and insulin compared to identical bread without fenugreek.   "
209588|NCT00586014|"     The purpose of this phase II study is to assess the toxicity and efficacy of sequentially     administered high dose chemotherapy followed by autologous stem cell rescue in the treatment     of multiple myeloma. Prior studies have shown that dose-intensified melphalan can produce     higher response rates and complete remission in some patients. Over the past several years,     multiple phase II studies utilizing high dose chemotherapy or high dose chemo-radiotherapy     with autologous marrow or peripheral blood stem cell rescue have demonstrated improved     response rates and survival rates compared to historical controls. Recently a prospective     randomized trial has demonstrated improved response rates, response duration and overall     survival utilizing high dose therapy with autologous bone marrow support compared to standard     chemotherapy. The primary cause of failure is relapse and it is unclear how many, if any,     patients are cured by this approach. Based on observations of efficacy in Hodgkin's Disease,     Non-Hodgkin's Lymphoma, and breast cancer, an approach utilizing sequential high dose     chemotherapy in multiple myeloma was developed. This protocol tests the sequential regimen in     multiple myeloma patients who have responded to a standard dose chemotherapy regimen prior to     enrollment.   "
209589|NCT00586027|"     Low output syndrome is a common complication in patients undergoing cardiac surgery. Its     incidence was reported to be 2 to 6%. Morbidity and mortality of low output syndrome is high     and the costs for treating the disease are immense.Natriuretic propeptide Type B (NT-proBNP)     is a biological marker for the diagnosis, prognosis and therapy of cardiac failure after     cardiac surgery.      Cardiac index and NT-proBNP will be correlated with morbidity and mortality. A critical     threshold value for intraoperative cardiac index and NT-proBNP will be calculated.   "
209590|NCT00586040|"     The broad aim of this study is to evaluate the efficacy of photochemical tissue bonding (PTB)     for the closure of skin excisions. We will test the hypothesis that full thickness skin     excisions treated with PTB can heal with less scarring than those treated with the     conventional suture closure method.   "
209591|NCT00586053|"     It is our objective to improve the performance of CTC in the prepared colon, and to validate     CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness     ratio of CTC in the unprepared colon will compare favorably with other colorectal screening     test.   "
209592|NCT00586066|"     The purpose of this study is to see whether memantine improves memory function in     participants with bipolar disorder who have minimal symptoms. Secondary analyses will test     the role of memantine in improving residual mood symptoms (depression and mania) in     participants with bipolar disorder.      We hypothesize that in participants with bipolar disorder who have minimal symptoms memantine     will be effective in improving cognitive functions, as measured by the difference in     neuropsychological test scores at the beginning and at the end of the trial.   "
209593|NCT00586079|"     The purpose of this study is to determine the effect of deep brain stimulation surgery on     movement-related cortical potentials in patients with Parkinson's disease.   "
209594|NCT00586092|"     The primary objective of this study is to determine the recommended Phase II dose for the     combination of ABT-510 plus bevacizumab in patients with advanced solid tumors and to     evaluate dose limiting toxicities and non-dose limiting toxicities of this combination. The     secondary objectives are to collect preliminary data on the effect of the combination of     ABT-510 plus bevacizumab versus each agent individually on dermal wound angiogenesis in a     skin biopsy and to collect preliminary data on the clinical activity of this combination     (tumor response rate, progression-free survival, rate of stable disease > 6 months).   "
209595|NCT00586105|"     A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic     renal cell carcinoma (RCC) to assess the pharmacokinetic profile, safety and tolerability,     and efficacy.   "
209596|NCT00586118|"     The evaluation of the presented study will work on the practicability of inhalative sedation     on the ICU, potential benefits and limitations of the ACD system in a postoperative sedated     patient population in comparison to a standard intravenous sedation regimen with propofol,     and focus on renal and hepatic function, cardioprotection and pharmacoeconomics   "
209597|NCT00586131|"     This study will test the hypothesis that by slightly lowering the acidity of blood (or     increasing the pH), dialysis patients utilize protein and amino acids more efficiently.   "
209598|NCT00586157|"     The purpose of this study is to investigate the effectiveness of a medication skin patch     called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a     placebo patch. We want to find out how well it treats ADHD during the early morning hours     before a child leaves for school or summertime routines.   "
209599|NCT00586170|"     The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th     metatarsal non-union fractures.   "
209600|NCT00586183|"     Our hypothesis is that altered cardiac sympathetic activity is present and may contribute to     the myocardial stunning observed in the apical ballooning syndrome.      Aim: Assess the extent and reversibility of cardiac adrenergic neuronal dysfunction using     carbon-11 hydroxyephedrine (C-11 HED), a positron emission tomography (PET) tracer, in     patients with the apical ballooning syndrome.   "
209601|NCT00586196|"     Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with     substantial morbidity within the hospital and beyond. Particular patient populations are at     high risk for poor outcomes after an episode of delirium. Patients with hip and other long     bone fractures are at increased risk of developing delirium (acute confusion) which impedes     functional recovery. This is a pilot study to test the tolerability and efficacy of     donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for     the prevention of new or worsening delirium in aged hip and other long-bone fracture     patients. Additional purposes involve gathering a small amount of patients' serum to better     understand the pathophysiology of delirium in this population.      The purposes of this pilot study are to determine: 1) the safety and tolerability a     cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To     obtain estimates of subject accrual and preliminary estimates of effect size on the     development of new delirium symptoms to allow for planning of a larger, definitive trial, 3)     To better understand the underlying causes of delirium by examining whether a measure of     blood anticholinergic activity relates to the incidence and persistence of delirium symptoms,     and 4) To explore the interaction between anticholinergic activity, donepezil therapy, and     delirium symptoms.   "
209607|NCT00586274|"     While stem cell transplantation has proven an effective means of treating a wide variety of     diseases involving hematopoietic stem cells and their progeny, a shortage of donors has     proved a major impediment to the widest application of the approach. Until recently, only MHC     identical donors could be used with safety. Such donors were originally siblings or other     closely related family members. Over the past decade, the growth of allogeneic donor panels     has allowed transplantation with stem cells obtained from a volunteer donor panel.      While it is now possible to obtain HLA identical unrelated donor stem cells for approximately     75% of individuals of Northern European backgrounds, the situation for most other ethnic     groups is much less satisfactory. Even when a matched donor can be found, the elapsed time     between commencing the search and collecting the stem cells usually exceeds three months, a     delay that may doom many of the neediest patients. Hence there has been considerable interest     in making use of HLA haploidentical family donors. Most individuals have a first-degree     relative who would be suitable for such protocols. Fanconi anemia (FA) is an autosomal     recessive disorder characterized by the development of progressive aplastic anemia usually     evident by about age seven years and often associated with various diverse congenital     anomalies such as short stature, microcephaly, radial anomalies, horseshoe kidney, and cafe     au lait spots.      This study will determine the number of donor lymphocytes that can be given to recipients of     haploidentical stem cell transplants with Fanconi anemia after depletion of     recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA     immunotoxin, and will result in a rate of Grade III/IV GVHD of < / = 25%.   "
209608|NCT00586287|"     Oral anticoagulation is often initiated in hospitalized patients. Although the therapeutic     range of phenprocoumon is narrow, the individual drug demands unfortunately vary greatly     between persons. Our group recently developed two dosing algorithms for the initiation of     anticoagulation based on clinical predictors such as age, gender, body weight and laboratory     values.      The aim of the proposed study is to prospectively evaluate the efficacy and safety of these     two algorithms in medical and orthopedic inpatients, as well as in a group of outpatients and     possibly in a geriatric collective.   "
209609|NCT00586300|"     Osteoarthritis (OA) is the most common joint-related disease and most prevalent form of     arthritis in the United States. Pain relievers and anti-inflammatory medications are the most     commonly prescribed treatments for OA. These medications, however, cannot completely     alleviate OA symptoms. Additional recommended strategies for managing OA include physical and     occupational therapy, exercise, and patient education. This study will compare the     effectiveness of a physical training program, a self-management training program, and a     program including both physical and self-management training for improving physical function     in people with early stage knee OA.   "
209620|NCT00586443|"     Targeting molecular pathways of tumor growth has become a major focus of anti-cancer     treatments. This study aims to investigate the toxicity, pharmacokinetics, and preliminary     efficacy of the triplet combination of bevacizumab, RAD001, and panitumumab in patients with     refractory solid tumors.      This open-labeled, non-randomized phase I trial of bevacizumab, everolimus and panitumumab is     designed to assess the safety, tolerability and efficacy of this combination in adult     patients with advanced solid tumors.   "
209639|NCT00586703|"     Evaluate the safety of natural killer (NK) cell infusion using CD56 monoclonal antibody     selected with Miltenyi Biotec system following nonmyeloablative stem cell transplantation     (SCT) from mismatched donors. This pilot study will evaluate toxicity including mortality,     occurrence of acute graft versus host disease (aGVHD) and other severe toxicity.   "
209610|NCT00586313|"     Endoscopic Ultrasound involves the placement of a small flexible camera through the mouth and     into the stomach to image various parts of the body. A small piece of tissue called a biopsy,     of your liver nay be obtained by this method. the tissue (biopsy) would be obtained by     inserting a small needle through the lining of the stomach into the liver. Consideration for     this biopsy is because there may be extra fat stored within the liver. In some people who     drink too much alcohol, extra fat may be stored in the liver, however, in some people who     don't drink too much alcohol, this may also occur and is called :non-alcoholic fatty liver     disease or NAFLD. Over time, this extra fat may lead to liver irritation and scar tissue     called cirrhosis. If NAFLD is detected early enough, then treatment with medications, losing     weight, or dietary changes may help avoid cirrhosis. the purpose of this study is to learn     about whether doctors can obtain the biopsy from the liver by a new method. The biopsy of the     liver allows the doctors to look for any signs of scar tissue or inflammation from any cause.   "
209611|NCT00586326|"     This study has been designed to compile information on the efficacy of the MammoSite RTS     providing sole radiation therapy for patients with pure DCIS.   "
209612|NCT00586339|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. The current study is designed to evaluate the safety and immunogenicity     of GlaxoSmithKline Biologicals' HPV vaccine 580299 in HIV infected adult females living in     the Republic of South Africa. The study is double blinded, randomized for HIV positive     subjects and open for HIV negative subjects. The Protocol Posting has been updated in order     to comply with the FDA Amendment Act, Sep 2007.   "
209613|NCT00586352|"     Inflammatory bowel disease, which includes both Crohn's disease and ulcerative colitis, is a     disease of the gastrointestinal tract leading to symptoms of abdominal pain, diarrhea, and     growth disturbance. Crohn's disease is a chronic inflammatory process that may affect any     part of the gastrointestinal tract, whereas ulcerative colitis is typically present only in     the colon. Children with inflammatory bowel disease frequently suffer from disturbances in     growth, which may continue into adulthood and result in altered growth outcomes. The     metabolic response to inflammatory bowel disease, including increased protein breakdown and     decreased protein synthesis may play a significant role in the resulting malnutrition and     growth failure from which children with inflammatory bowel disease suffer. The purpose of     this study is to compare the rates of protein synthesis within the mucosal lining of the     gastrointestinal tract in children Crohn's disease or ulcerative colitis to children who have     normal endoscopic examinations. By comparing children with inflammatory bowel disease to     normal children, we can begin to determine how alterations in protein metabolism within the     lining of the gastrointestinal tract affect whole body protein metabolism, and its consequent     effects on growth. In those patients diagnosed with Crohn's disease or ulcerative colitis, a     follow-up study will be conducted two weeks following the initiation of steroid therapy to     determine its effects on protein metabolism. We hypothesize that children with active     inflammatory bowel disease will have increased rates of protein synthesis in the lining of     the gastrointestinal tract than patients who have normal endoscopy, and that increases in     protein breakdown and protein synthesis will be improved following steroid therapy in     children with newly diagnosed inflammatory bowel disease.   "
209680|NCT00597116|"     A clinical study to assess if a new investigational drug is effective in treating malignant     mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients     will be assigned by chance to receive either the new drug or a chemotherapy treatment     (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient     wishes to continue in the study. The study will recruit approximately 66 patients.   "
209614|NCT00586365|"     Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification).     This new bone is unwanted and it can restrict motion. This research study is being done to     learn more about the effect of the drug naproxen, on unwanted formation of new bone around     the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs     which stands for non-steroidal anti-inflammatory drugs.      Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted     formation of new bone around the hip. The effect of NSAIDS on the formation of bone around     the elbow has not been studied as well as it has been studied for their effect on the hip.      The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot     specifically for the treatment of heterotopic ossification.   "
209615|NCT00586378|"     The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio     DR and VR ICDs   "
209616|NCT00586391|"     Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma, Acute     Lymphocytic Leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as     Lymphoma or Leukemia). Their Lymphoma or Leukemia has come back or has not gone away     after treatment (including the best treatment known for these cancers). This research study     is a gene transfer study using special immune cells.      The body has different ways of fighting infection and disease. No one way seems perfect for     fighting cancers. This research study combines two different ways of fighting disease,     antibodies and T cells, hoping that they will work together. Antibodies are types of proteins     that protect the body from bacterial and other diseases. T cells, also called T lymphocytes,     are special infection-fighting blood cells that can kill other cells including tumor cells.     Both antibodies and T cells have been used to treat patients with cancers; they have shown     promise, but have not been strong enough to cure most patients.      T lymphocytes can kill tumor cells but there normally are not enough of them to kill all the     tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in     the laboratory and then given them back to the person.      The antibody used in this study is called anti-CD19. It first came from mice that have     developed immunity to human lymphoma. This antibody sticks to cancer cells because of a     substance on the outside of these cells called CD19. CD19 antibodies have been used to treat     people with lymphoma and Leukemia. For this study anti-CD19 has been changed so that instead     of floating free in the blood it is now joined to the T cells. When an antibody is joined to     a T cell in this way it is called a chimeric receptor.      In the laboratory, investigators have also found that T cells work better if they also put a     protein that stimulates T cells called CD28. Investigators hope that adding the CD28 might     also make the cells last for a longer time in the body.      These CD19 chimeric receptor T cells with C28 T cells are investigational products not     approved by the Food and Drug Administration.      The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to     see how the T cell with this sort of chimeric receptor lasts, to learn what the side effects     are and to see whether this therapy might help people with lymphoma or leukemia.   "
209617|NCT00586404|"     This trial is a multi-center clinical and endoscopic outcomes project involving a single     large database of patients with Barrett's Esophagus (BE). The initial goal of this project is     to define the incidence and prevalence of cancer and high-grade dysplasia (HGD) in patients     with BE. Thus, our hypothesis is that systematic collection of data on the natural history of     BE and risk factors for progression of BE will provide useful information to develop a     decision model for risk stratification and risk reduction strategies in BE.   "
209618|NCT00586417|"     The overall goal of this study is to determine the feasibility and the variability of several     biomarker assays in normal subjects that are relevant to tumor biology and novel anti-cancer     treatments, with the goal of refining these assays for use in future therapeutic studies.   "
209619|NCT00586430|"     We expect the results of this pilot study to justify a larger study that follows people to     determine if certain tests of memory and attention, performed while sleepiness is induced by     a single dose of lorazepam (a widely used anti-anxiety medication) could predict an     individual's risk of developing AD. We plan to compare cognitively normal people who possess     a common gene that increases risk for AD— the apolipoprotein E (APOE) e4 allele—to     individuals without this gene. We hypothesize that a single 2 mg dose of lorazepam will cause     more cognitive impairment in carriers of the APOE e4 allele than in noncarriers, and that the     carriers will recover more slowly from these impairments than noncarriers.   "
209638|NCT00586690|"     Evaluate the safety of natural killer (NK) cell infusion using CD56 monoclonal antibody     selected with Miltenyi Biotec system following nonmyeloablative stem cell transplantation     (SCT) from matched donors. This pilot study will evaluate toxicity including mortality,     occurrence of acute graft versus host disease and other severe toxicity.   "
209621|NCT00586469|"     Vaccination is currently the most effective means of controlling influenza and preventing its     complications and mortality in persons at risk.      Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a     recommendation on the influenza A and B strains that should be used for the production of     vaccine for the coming influenza season. For the strains which do not change from the     previous year, the vaccine can be formulated from the old mono bulk from the previous year.      Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under     the current Canadian and US licenses. This study is conducted to evaluate safety and     immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new     bulk material. This protocol posting has been updated in order to comply with the FDA     Amendment Act, Sept 2007.   "
209622|NCT00586482|"     The goal of this pilot study is to determine the feasibility and potential effect size of     nicotine lozenges as an adjunct to maintain brief preoperative abstinence, defined as not     smoking the day of surgery.   "
209623|NCT00586495|"     Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients     with renal cell carcinoma (RCC).   "
209624|NCT00586508|"     The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment     recurrent malignant gliomas.   "
209625|NCT00586521|"     The purpose of the study is to evaluate the effect of prophylactic treatment on the number of     joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand     treatment in a one-group two-treatment schedule design.      In addition, the effect of prophylactic treatment on the joint function, the number of all     bleeds, and on the quality of life compared to on-demand treatment and health-economic data     will be assessed.   "
209626|NCT00586534|"     The purpose of our research is to examine the promise of a new computer based approach to use     in usual drug counseling when treating crack cocaine addiction.   "
209627|NCT00586547|"     This study is designed to determine the number of donor lymphocytes that can be given to     recipients of haploidentical stem cell transplants after depletion of recipient-reactive T     lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin, and will result     in a rate of Grade III/IV GVHD of < / = 25%, to analyze immune reconstitution in these     patients, and to measure their overall and disease free survival, at 100 days and at 1 year.   "
209681|NCT00597129|"     Safety study to determine highest dose of 90Y-hPAM4 can be safety administered   "
209628|NCT00586560|"     This is a Phase 1, open-label, single-center, dose-escalating study in pediatric patients     with refractory or recurrent solid tumors. Patients will be registered into 1 of 2 strata,     depending upon the presence bone marrow metastases or previous treatment with intensive     myelosuppression therapy. Patients will receive Karenitecin along with cyclophosphamide daily     for 5 consecutive days, every 21 days (1 treatment cycle). Treatment may continue for up to     20 cycles, as long as there is continued evidence of clinical benefit and an absence of     unacceptable toxicity.   "
209629|NCT00586573|"     The primary objective of the study is to assess the efficacy and tolerability of a 12-week     trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD     and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the     investigator-rated DSM-IV based ADHD Rating Scale; 2) changes from baseline in a     questionnaire aimed at assessing executive functions (BRIEF); and 3) changes from screening     in a computerized neuropsychological battery (CANTAB). We hypothesize that memantine     hydrochloride will be associated with improving ADHD symptoms and associated deficits in     executive functions. We also expect that memantine will be well-tolerated with predictable     adverse events.   "
209630|NCT00586586|"     The study aims to evaluate the effectiveness of a cognitive behaviour therapy program     (FRIENDS) for anxiety disorders in children aged 8-15 years who have been referred to child     and adolescent mental health clinics in Western Norway.   "
209631|NCT00586599|"     The goal in these studies will be to assess the relative levels of the Stat4 alpha and Stat4     beta isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, celiac disease     or from control patients. We hypothesize that the beta to alpha ratio will be higher in     patients with active disease and that there will be a correlation between the ratio and the     severity of disease.   "
209632|NCT00586612|"     The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity &     safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK     Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta) & Wyeth's 7-valent pneumococcal conjugate     vaccine (Prevenar™) in preterm infants as a 3-dose primary vaccination course during the     first 6 months of life (at 2, 4, 6 months of age) and of a booster dose of Menitorix™ when     co-administered with GSK Biologicals' DTPa-IPV vaccine (Infanrix IPV) and Wyeth's Prevenar in     the second year of life (16-18 months of age). The control is a group of full-term infants     receiving the same vaccines. The Protocol Posting has been updated in order to comply with     the FDA Amendment Act, Sep 2007.   "
209633|NCT00586625|"     Safety study for bepotastine besilate ophthalmic solution in normal volunteers   "
209634|NCT00586638|"     Control processes are classes of brain activity that initiate, coordinate, synchronize, and     regulate elemental cognitive functions for the conduct of goal-directed behavior. The     proposed research investigates whether exposure to a computer-based training protocol     designed to enhance cognitive control processes will improve cognitive performance in healthy     older adults.   "
209635|NCT00586651|"     This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of     CEP-701 (lestaurtinib) treatment in patients with Polycythemia Vera (PV) and patients with     Essential Thrombocytosis (ET).   "
209636|NCT00586664|"     Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic     conjunctivitis   "
209637|NCT00586677|"     The purpose of this research is to evaluate specific parenting programs that aim to improve     the family's ability to keep children physically safe and emotionally secure. We would like     to learn more about how the treatments actually help families and to find out how an     intervention that focuses on child health and safety compares with one that focuses on the     parent and child relationship. We also want to determine whether participating in one program     type versus the other results in further reports for child maltreatment.   "
209654|NCT00595790|"     The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51     (JE-PIV) in healthy subjects aged > or = 18 years   "
209640|NCT00586716|"     The purpose of this study is to test the clinical and laboratory observations of IVIG therapy     in the highly sensitized patient. We will study the effects of patients treated with IVIG or     Cytogam in combination with plasmaphoresis to modulate the immune response in highly     sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch     that would allow living related transplant to take place or to shorten time on the transplant     waiting list.   "
209641|NCT00586729|"     This study will evaluate the efficacy, safety, and tolerability of topical Vashe™ Wound     Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist versus     5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing     moist for a total treatment duration of 5 days.   "
209642|NCT00586742|"     The purpose of this study is to evaluate whether there is a difference between conservative     and operative treatment of Superior Labral Lesions(SLAP)of the shoulder.   "
209643|NCT00586755|"     Patients with mantle cell lymphoma have a grave prognosis. They usually have an initial     response to therapy, however progress early in the course of the disease and have very poor     survival. We hypothesize that the emergence of drug resistance is responsible for this early     failure of therapy and therefore intensive therapy at induction followed by high dose therapy     immediately may produce a better outcome.   "
209644|NCT00586781|"     The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with     bilateral disease.   "
209645|NCT00586794|"     Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that     constitutes a great burden at the individual as well as the familial and social level. The     combination of critically increased pulmonary vascular resistance, progressive pressure load     of the right ventricle and disturbance of pulmonary gas exchange result in long-term     polymorbidity. The objective of this study is to provide evidence of improvement of patients     exercise tolerance as well as general conditions by treatment with oral sildenafil as a     specific pulmonary vasodilator.   "
209682|NCT00597142|"     The purpose of this study is to demonstrate superior 9-month binary restenosis rate of the     Express™ Renal Premounted Stent System as compared to an Objective Performance Criterion     representative of PTRA, for atherosclerotic lesions in the aortorenal ostium.   "
211098|NCT00617994|"     This will be an open label study of INCB018424 topical cream applied to 2 - 20% BSA in     patients with active, stable plaque psoriasis.   "
209646|NCT00586807|"     The metabolic response to ulcerative colitis, including increased proteolysis and lipolysis     and changes in energy expenditure, plays a significant role in the resulting malnutrition     from which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory     cytokine, has been found to be elevated in children with ulcerative colitis. TNF-alpha has     been incriminated in the mechanism of weight loss in many different chronic diseases, and     causes net protein and lipid catabolism. Anti-TNF-alpha antibody (infliximab) has been proven     to be an effective therapy for ulcerative colitis.      The purpose of this study is to determine changes in protein and lipid metabolism, as well as     resting energy expenditure, before and after therapy with anti-TNF-alpha antibody     (infliximab) in children with ulcerative colitis. Performing this study will better define     the changes in nutrition status observed in these children following remission of active     ulcerative colitis, and potentially lead to changes in medical and nutritional management of     these children   "
209647|NCT00586820|"     Percutaneous coronary intervention (PCI) for acute coronary syndromes frequently fails to     restore myocardial perfusion despite establishing epicardial vessel patency. Endothelin-1     (ET-1) is a potent vasoconstrictor and its expression is increased in atherosclerotic     coronary arteries. Our hypothesis is that increased activity of the endogenous endothelin     system contributes to microvascular dysfunction, and adjunctive therapy with an endothelin     receptor antagonist will result in improved microvascular blood flow.      Aims: The aims of the study are to assess in patients with non ST-elevation myocardial     infarction, whether: 1) PCI causes an increase in coronary blood ET-1 level; 2) an endothelin     receptor antagonist acutely improves coronary microvascular blood flow following PCI.      Non-ST segment elevation myocardial infarction (NSTEMI) is one type of heart attack. It is     defined as the development of heart muscle necrosis results from an acute interruption of     blood supply to a part of the heart which is demonstrated by an elevation of cardiac markers     Creatinine Kinase Isoenzyme Muscle/Brain Type (CK-MB) in the blood and the absence of     ST-segment elevation in ECG (electrocardiography). ST-segment is a portion of ECG, its     elevation indicates full thickness damage of heart muscle. Absence of ST-segment elevation in     NSTEMI indicates partial thickness damage of heart muscle occurs. Therefore, NSTEMI is less     severe type of heart attack compared to STEMI (ST-segment elevation myocardial infarction) in     which full thickness damage of heart muscle occurs.   "
209648|NCT00586833|"     This will be a cross sectional study comparing patients with HFpEF and age-matched, non-HF     controls recruited from the community. This design will allow for determination of     biologically relevant differences in baseline ventricular and vascular function, and     importantly, differences in the ability to augment ventricular and vascular function     dynamically during exercise stress, when symptoms of HF typically are first noted. The     endpoint of exercise-reserve function is novel and has been little examined in the existing     HFpEF literature.   "
209649|NCT00586846|"     This study is designed to test the safety and feasibility of the simultaneous administration     of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed     patients.   "
209650|NCT00586859|"     The purpose of this study was to evaluate the safety and efficacy of placing multiple     transmural sutures for the treatment of GERD.      A prospective, multi-center, open-label trial was conducted at four centers in Germany to     evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD.     Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL)     questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were     heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication     use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87%     power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.   "
209651|NCT00586872|"     Existing records will be reviewed to evaluate the predictors of complications including     stricture formation, bleeding or perforation associated with endoscopic mucosal resection   "
209652|NCT00595764|"     The major goal is to determine whether adding cognitive behavioral therapy to physician     management will increase the efficacy of buprenorphine/naloxone treatment in an office-based     primary care setting.   "
209653|NCT00595777|"     To determine if the institutionalisation of a regular systematic approach to the assessment     of pain in inpatient cancer units using the Edinburgh Pain Assessment Tool (EPAT©) leads to     better control of pain than that achieved by usual care.   "
209655|NCT00595816|"     The purpose of this clinical trial is to study the effect of neuromuscular training program     and regular safety counselling on the risk of musculoskeletal injuries in adolescent     conscripts.      800 voluntary participants are recruited from the four army companies in western Finland     during the years 2007 and 2008.   "
209656|NCT00595829|"     The purpose of this study is to evaluate the safety and tolerability of the JAK2 inhibitor     XL019 administered orally in adults with Polycythemia Vera.   "
209657|NCT00595842|"     This study retrospectively looks to determine the clinical success of ProRoot MTA used as an     artificial apical barrier in teeth with immature apices.   "
209658|NCT00595855|"     Patients affected by medically uncontrolled open angle glaucoma will be randomised to either     a non penetrating procedure (deep sclerectomy) or conventional trabeculectomy. The longterm     efficacy (i.e. IOP w/out therapy) and safety (i.e. visual acuity, visual field stability and     co-morbidities) will be evaluated.   "
209659|NCT00595868|"     The purpose of this study is to test whether Varenicline can help ambivalent smokers (those     who are interested in quitting at some point in the future but have no current plans to quit)     to reduce their smoking and eventually quit.   "
209660|NCT00595881|"     The purpose of this study is to determine if soft tissue infections in pediatric patients can     be more accurately diagnosed (i.e. the presence of a drainable abscess) with the addition of     bedside ultrasound to the clinical examination compared to the clinical examination alone.   "
209661|NCT00595894|"     The objective of the proposed study is to assess bone health and determinants of bone health     among select subpopulations of rheumatoid arthritis patients.   "
209683|NCT00597168|"     This is a non-interventional study evaluating quality of life in schizophrenic patients     treated with atypical antipsychotics, in the ambulatory setting. This is a 9-month,     observational, multicentric prospective study.   "
211099|NCT00618007|"     To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving     metformin   "
209662|NCT00595907|"     New blood tests have become available to detect either latent or active tuberculosis. These     tests - which according to the CDC can replace the tuberculin skin test - measure the     production of gamma-interferon (a cytokine) by peripheral lymphocytes (white cells) when     exposed to antigens which are highly specific of mycobacterium tuberculosis (the bacteria     responsible for tuberculosis). Our hypothesis was that the production of gamma-interferon     would be much higher at the beginning of treatment than at the end, and that decline in     gamma-interferon secretion could be an indicator of clinical response to treatment.   "
209663|NCT00595920|"     The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the     treatment of relapsing forms of multiple sclerosis.   "
209664|NCT00595933|"     The purpose of this study is to compare the effectiveness of over-the-counter remedies for     dry mouth.   "
209665|NCT00595946|"     The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone     administration in patients with Opioid-induced Bowel Dysfunction.   "
209666|NCT00595959|"     The objective of this study is to evaluate the safety and efficacy of the CLiRpath®     Photoablation Atherectomy System consisting of the Bias Sheath guiding catheter, in     combination with the available CLiRpath® Excimer Laser Catheters ≤ 2.0 mm, to create larger     lumens for treatment within the superficial femoral and popliteal arteries above the knee.   "
209667|NCT00595972|"     The purpose of this study is to evaluate the efficacy and tolerability of the ECF regimen     (epirubicin, cisplatin and FU) combined with endostar-- a inhibitor of angiogenesis, in     patients with advanced or metastatic gastric cancer (A/MGC).   "
209668|NCT00595985|"     The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second     line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).   "
209669|NCT00595998|"     The primary objective of this study is to estimate the sensitivity of the HMP test in     identifying visual field functional defects in subjects with CNV secondary to AMD, and     differentiate them from intermediate AMD subjects.   "
209670|NCT00596011|"     The purpose of this study was to determine whether the daily consumption of decaffeinated     green tea catechins (Polyphenon E®) for 1 year reduces the rate of progression to prostate     cancer (PCa) in men diagnosed with HGPIN or ASAP. The aim was to recruit and treat 240 (120     men/arm) men diagnosed with the prostate condition HGPIN or ASAP with a capsule form of     standardized green tea extract called Polyphenon E or placebo for a 12-month period and see     if it can prevent progression of the prostate condition to prostate cancer. Investigators     wanted to see if Polyphenon E reduces lower urinary tract symptoms and if this can be taken     safely over one year. Investigators wanted to study how Polyphenon E is able to slow the     progression to prostate cancer, or the mechanism of action of Polyphenon E. If the safety and     the effects of Polyphenon E on slowing down the progression of prostate cancer is shown in     our study, this will be a safe way of treating men who are at high risk or men like you who     have a prostate condition that increases your chances of getting prostate cancer, so that we     can prevent prostate cancer in the future.   "
209671|NCT00596024|"     Oxidative damage by free radicals may be involved in causing Alzheimer's disease (AD). Free     radicals may lead to death of nerve cells and decline in brain function. Certain antioxidants     may suppress this free radical damage associated with AD. Carotenoids are a family of     naturally occurring antioxidants that have important functions for human health. Carotenoids     are known to reduce oxidative damage, but their effects have not been studied in AD patients.      The objective of the study is to examine whether lutein supplementation helps to reduce     oxidative damage from free radicals in AD patients.   "
209672|NCT00596037|"     The objective of this rollover study is to evaluate the long term (1 year) safety of a new     weekly administered growth hormone preparation in adults with growth hormone deficiency who     were treated with the same experimental preparation in study BPLG-005. In addition, further     change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated. Additional     efficacy and safety data of the experimental preparation will be obtained from the     switch-over patients.   "
209673|NCT00596050|"     There are multiple retrospective studies detailing the use of etomidate in pediatric     procedural sedation but few to no prospective clinical trials. None have compared etomidate     to ketamine, currently the most commonly used sedative in the emergency department for     pediatric procedural sedation. The investigators propose a randomized, controlled trial     comparing etomidate versus ketamine for procedural sedation for fracture reduction for     children presenting with extremity fracture requiring sedation for reduction. The     investigators hypothesize that etomidate in combination with fentanyl will have similar     reduction of distress and procedural recall as ketamine in combination with midazolam.   "
209676|NCT00596089|"     Decline in muscle function may increase risk of hip fracture and decrease quality of life.     Different tests are currently used to measure muscle function but they do not work for all     individuals. A test called jumping mechanography, which measures jumping power, may be     useful in more people and obtain better information. This study will help us determine     whether this test is able to detect differences between muscle function in younger and older     adults, as well as whether it is a safe method to use in all ages.   "
209677|NCT00596102|"     The study investigates the long term safety and immunogenicity of the Japanese Encephalitis     vaccine IC51 up to month 60.   "
209678|NCT00597090|"     The purpose of this study is to better understand genetic susceptibility to infections and     the interactions of specific genetic polymorphisms of innate immune receptors with microbial     and fungal organisms.      The goals of this study are:        1. Find out if some people are more likely to get severe infections, than others. To do          this we will compare patients with leukemia who develop severe infections to patients          who do not develop infections.        2. Find out if some people are more likely to develop lymphoma than others. To do this we          will compare patients with lymphoma to people without lymphoma who are of the same sex          and similar age and ethnic background to the patients with lymphoma.   "
209679|NCT00597103|"     This study will evaluate the effects of more frequent dialysis on cognitive function     including the assessment of sleep apnea and restless legs. Our hypothesis is that more     frequent dialysis improves cognitive function and may have important implications on clinical     care of ESRD patients and help to emphasize the need for treatments that will allow patients     to live with dialysis rather than live for dialysis.   "
209687|NCT00597220|"     To demonstrate that in patients with persistent atrial fibrillation who had recovered normal     sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily     of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus     rhythm at one year of follow up.   "
209688|NCT00597233|"     This trial is conducted in South America. This aim of this trial is to evaluate the     comparative prandial blood glucose lowering profile in subjects with type 1 diabetes.   "
209689|NCT00597246|"     This research protocol makes pictures of brain tumors. The pictures are made with a positron     emission tomography (PET) scanner. PET scans use radioactivity to see cancer cells. We are     using a new kind of PET scan. The new PET scan is called [18F]-FACBC PET. We will compare     this to the standard PET scan. The standard PET scan is called [11C]-methionine PET.      We expect these pictures will give us information about your tumor. We also hope to collect     information about the amount of radioactivity exposure. We will measure radioactivity     exposure to your tumor, brain and other organs. The research study results will be used to     support the submission of an investigational new drug (IND) application to the Food and Drug     Administration (FDA).   "
209690|NCT00597259|"     Although the best treatment choice for chronic hepatitis B is not clarified yet, certain     therapeutic concepts could be derived from the experience of treating patients with chronic     hepatitis C or human immunodeficiency virus (HIV) infection. A major advancement in treating     hepatitis C or HIV infection has been the development of combination therapy. Whether the     combination therapy using Peg-IFN alfa-2a plus ETV can achieve a long-term beneficial effect     against ETV alone is not clarified. A prior single-arm pilot study suggested that similar     combination therapy may be beneficial in patients with chronic hepatitis B. In this proposal,     we thus hypothesize that the efficacy by using combination therapy with pegylated IFN alfa-2a     plus ETV is superior to that by using ETV alone in that Peg-IFN may restore host immunity     against HBV and prolonged ETV can maximize viral suppression.      The objective of this clinical trial is to evaluate the efficacy of the combination of     Peg-IFN alfa-2a at a dose of 180 mcg administered subcutaneously per week and ETV 0.5 mg     daily for 24 weeks followed by ETV 0.5 mg daily monotherapy for an additional 120 weeks     versus ETV 0.5 mg daily monotherapy for 144 weeks in patients with HBeAg-positive chronic     hepatitis B. It will be an open-label, randomized, comparative, multi-center clinical trial.     The recruited patients will be equally randomized into two treatment groups. Treatment-free     follow-up period will be 48 weeks in both groups of patients. All subjects will be assessed     for loss of HBeAg, presence of anti-HBe, loss of HBsAg, presence of anti-HBs, suppression of     HBV DNA, and normalization of serum ALT at the end of treatment and end of follow-up.     Genotypic and virologic resistance to ETV will also be assessed at baseline and at end of     years 1, 2 and 3. The primary efficacy will be HBeAg seroconversion.   "
209803|NCT00598793|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a     standard dosing of insulin glargine plus metformin on blood glucose control in subjects with     type 2 diabetes who are insulin naive and failing OAD therapy.   "
209691|NCT00597272|"     Vaccines contain substances that help us make antibodies. Different antibodies help protect     us against a variety of harmful things. GD2 and GD3 gangliosides are substances found on the     surface of most melanoma cells. They are also occasionally found on some normal cells. Large     quantities of antibodies called monoclonal antibodies have been prepared in the laboratory     against GD2 and GD3 and given to patients with metastatic melanoma. In about 10% of cases     this has resulted in clinically relevant regression of melanomas. These monoclonal antibodies     are not currently available or used in the clinic but studies in the laboratory indicate that     vaccines against GD2 and GD3 can be as effective as monoclonal antibodies.      In this trial we wish to raise the level of antibodies in your blood against GD2 and GD3. We     will vaccinate you with the modified forms of GD2 called GD2 lactone and GD3 called GD3     lactone (GD3L), all attached to the antibody booster KLH, and mixed with the immune booster     (immunologic adjuvant) QS-DG. While over a thousand patients have received vaccines with     QS-21, the QS-DG used here is synthesized for the first time at MSKCC and is referred to as     QS-DG rather than QS-21 which is purified from tree bark. QS-21 and QS-DG are, to the best of     our knowledge chemically identical. It is unknown if using this bivalent vaccine will raise     the level of antibodies in your blood to either ganglioside. It is unknown if raising the     level of antibodies in your blood will lower your risk of relapse. This study will check your     blood for production of antibodies, and check you for side effects.   "
209692|NCT00597285|"     This study will look for evidence that a virus called HHV-6B may be related to seizures and     to a form of brain injury called mesial temporal sclerosis that is associated with seizures.     The study will use new, more sensitive brain scans to try to detect brain regions that might     be affected by the virus and will examine cerebrospinal fluid (CSF, the fluid that bathes the     brain and spinal cord) for evidence of the virus as well.      Healthy volunteers and people with seizures uncontrolled by anti-epileptic drugs who are     between 18 and 45 years of age may be eligible for this study. Candidates are screened with a     physical examination and laboratory tests.      Participants undergo the following procedures:        -  PET scan. This test uses a radioactive chemical called 18FDG, which is detected by the          PET scanner to obtain images of the brain. The subject lies on a table with his or her          head positioned in the scanner. A swimming cap with a small light reflector is placed on          the head to monitor the position of the head during the scan. A catheter (plastic tube)          is inserted into an artery at the wrist or elbow crease of the arm for obtaining blood          samples during the scan, and a second catheter is placed in a vein in the other arm for          injecting the 18FDG. The scan takes up to 2 hours. A second scan may be done over an          additional 15 minutes.        -  MRI. This test uses a strong magnetic field and radio waves to obtain images of the          brain. The subject lies on a table that can slide in and out of a metal cylinder          surrounded by a magnetic field. Most scans last between 45 and 90 minutes.        -  Lumbar puncture. The subject sits upright or lies on a table with the knees curled to          the chest for this procedure. A local anesthetic is injected to numb the skin and a          needle is inserted in the space between the bones in the lower back where the CSF          circulates below the spinal cord. A small amount of fluid is collected through the          needle.        -  Blood tests. About 4 tablespoons of blood are drawn for viral tests.   "
209693|NCT00597298|"     Diaphragm paralysis is a possible complication of cardiac surgery. The spontaneous recovery     of the diaphragm mobility is slow and partial or absent in most cases. We hypothesize that a     program of diaphragm muscle training by means of the Threshold variable resistance device     could improve the rate of complete diaphragm mobility recovery in a shorter time period.     Patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific     training protocol or to a generic non-training physical activity.   "
209694|NCT00597311|"     Trial compares two preoperative stage II and III rectal cancer treatment strategies: short     term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional     chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.   "
209698|NCT00597363|"     BACKGROUND. Arterial access site complications remain the most frequent adverse events after     percutaneous transluminal procedures. We investigated the safety and efficacy of the     pro-coagulant wound dressing Neptune Pad ® compared to conventional manual compression for     access site management after peripheral percutaneous interventions.      METHODS. We enrolled 201 consecutive patients and randomly assigned patients for Neptune Pad     ® (n=100) vs. conventional manual compression (n=101). Patients were followed clinically     until hospital discharge and by duplex ultrasound at 24 hours postprocedure for occurrence of     access site complications. Time-to-hemostasis and time-to-ambulation were recorded, patients´     and physicians´ discomfort were measured using a visual analogue scale.   "
209699|NCT00597376|"     The purpose of this six-month research study is to determine if Cerefolin NAC reduces levels     of substances in the blood that may be associated with thinking ability and the health of     brain cells in subjects with memory concerns when compared to a standard multivitamin.     Cerefolin NAC is available as a dietary supplement via a prescription from a physician. The     multivitamin used in the study contains the Recommended Daily Intake recommended for older     persons.   "
209700|NCT00597389|"     Twenty-nine pediatric injury patients (ages 10-18) at risk for PTSD were randomly assigned to     receive either propranolol or placebo in a double-blind placebo controlled design. Medication     was initiated within 12 hours of hospital admission. At 6-weeks, child PTSD symptoms and     heart rate (HR) during trauma recall were assessed. We hypothesized that participants who     received propranolol would report fewer PTSD symptoms and have lower heart rates than those     who received placebo.   "
209701|NCT00597402|"     Primary objective: To use overall survival to assess the efficacy of the combination of     radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan     in the treatment of grade IV malignant glioma patients following surgical resection.      Secondary objective: To determine the progression-free survival following the combination of     radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and     irinotecan.      Exploratory Objective: To explore the relationship between biomarkers and outcome (overall     survival and progression-free survival) among patients with grade IV malignant glioma treated     with radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and     irinotecan.      To describe the toxicity of radiation therapy,temozolomide and Avastin followed by Avastin,     temozolomide, and irinotecan.   "
209702|NCT00597415|"     The purpose of this study is to compare the efficacy of celecoxib versus placebo in delaying     the onset of pain and improving walking function in subjects with knee Osteoarthritis   "
209704|NCT00597441|"     The objective of this trial is to assess the toxicity of thymus transplantation following     unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events     that are not typically associated with umbilical cord blood transplantation. Also, to     determine whether engraftment of a third party thymus allograft is feasible in patients who     have undergone unrelated umbilical cord blood transplantation.   "
209705|NCT00597454|"     The purpose of the research is to examine the usefulness of using patient navigators in     improving coordination of care between the Breast Examination Center in Harlem (BECH) and the     Ralph Lauren Center for Cancer Care and Prevention (RLCCCP) for patients with a suspicious     breast finding. This study will collect information to improve the role of the Patient     Navigator, nonmedical staff that helps coordinate patient care. The study will also collect     information to be used to help remove barriers that happen when several different     institutions provide care.   "
209706|NCT00597467|"     To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear     basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.   "
209707|NCT00597480|"     Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height     during childhood and final height in children born small for gestational age (SGA). Because     rhGH has been associated with increased insulin levels and insulin resistance, concern has     been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes     mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA     children.   "
209708|NCT00597493|"     PURPOSE AND OBJECTIVES:      Primary Objective To evaluate the activity of Sorafenib plus protracted, daily temozolomide     in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month PFS.      Secondary Objectives To evaluate the safety and toxicity of combination therapy using     Sorafenib plus temozolomide; To determine the pharmacokinetics of Sorafenib when combined     with temozolomide in patients on and not on concurrent EIAC medications.   "
209709|NCT00597506|"     The purpose of this study is to find the safest and most effective dose of the drugs     bevacizumab and everolimus given in combination for the treatment of metastatic colorectal     cancer. Bevacizumab (also called Avastin™) is a drug that is given intravenously (through a     vein). Everolimus (also called RAD001) is a tablet that is taken by mouth.      Bevacizumab is a protein that is thought to prevent the formation of blood vessels tumors     need to grow. RAD001 has multiple capabilities, like bevacizumab it may prevent the formation     of blood vessels needed by tumors and it also may stop tumor growth.      This study will try to find the safest dose of these drugs that can be tolerated when taken     in combination. The study will look at how the drugs work in the body, and will see if there     is any effect on metastatic colorectal cancer.   "
209710|NCT00597519|"     In this study two cord blood collections will be used to increase the number of cord blood     cells you will receive on transplant day. We call this a double unit cord blood transplant.     A previous study suggests double unit cord blood transplant may have a better result. The     main purpose of this study is to find out how good a cord blood transplant using two cord     blood collections from two different babies is at curing you of your cancer. Double unit cord     blood transplants are now being studied as a way to increase the number of cord blood cells     given to bigger children and adult patients.      Based on studies that have already been done double unit cord blood transplant appears to be     safer than if only one cord blood unit is used. However, double unit cord blood transplant is     a fairly new form of treatment.   "
209732|NCT00597818|"     The primary purpose of this study is to determine the efficacy and safety of three dose     levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID.   "
209733|NCT00597831|"     The purpose of this study is to determine whether electroconvulsive therapy (ECT) has an     influence on pressure within the human brain before, during and after ECT.   "
209711|NCT00597532|"     To Test Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast     Tissue using a Randomized Placebo Controlled Study.      Objectives:        -  To determine (by immunohistochemistry) whether specific cellular markers and gene          products associated with breast carcinoma can be altered by soy therapy.        -  To identify genes that can be altered by soy therapy in normal and neoplastic breast          tissues by unbiased gene expression analysis using microarrays.        -  To compare specific cellular markers and pathways (immunohistochemistry), and gene          expression using microarrays in normal and cancerous breast tissue.   "
209712|NCT00597545|"     The purpose of this study is to determine if we can reduce the incidence of cognitive     dysfunction — difficulty in performing certain pencil-paper, memory, finger dexterity and     thinking type of tasks called neuropsychometric tests — in patients with adult onset diabetes     mellitus (DM) undergoing surgery on the carotid artery (CEA).      We hypothesize that cognitive dysfunction can be decreased in patients with type II DM by     augmenting cerebral blood flow with a shunt during carotid endarterectomy compared to     patients with Type II DM who are treated with conventional management in which a shunt is     placed only if the electroencephalogram (EEG) indicates cerebral ischemia.   "
209713|NCT00597558|"     The purpose of this study is to determine if children with egg allergy can be desensitized to     egg protein and if this desensitization can help them outgrow their egg allergy at an earlier     time than normal. Our hypothesis is that children with egg allergy can be orally desensitized     to egg protein and that this desensitization will help them outgrow their egg allergy at an     earlier time than normal.   "
209714|NCT00597584|"     The purpose of this study was to evaluate the safety and efficacy of peginesatide in the     maintenance treatment of anemia in participants on dialysis.   "
209715|NCT00597597|"     The goal of this trial is to determine the activity of erlotinib in a rationally selected     population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast     cancer. If erlotinib is shown to have activity, this could identify a form of targeted     therapy for this specific subset of breast cancer patients. In addition, it may identify a     subset of breast cancer patients with tumors that overexpress EGFR in whom other EGFR     targeted therapies could warrant further testing.   "
209740|NCT00597922|"     Heart disease and heart attacks pose a serious health risk to young women, and women tend to     experience less successful recoveries after a heart attack than men do. This study will     examine various factors that may predispose women to heart attacks and to poor recovery after     a heart attack. The differences between men and women in the medical care that they receive     following a heart attack will also be studied.   "
209804|NCT00598806|"     The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in     randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of     Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.   "
209716|NCT00597610|"     Traditional transrectal ultrasound (TRUS) is a technique used to help determine the stage of     rectal cancer. All patients at Memorial Sloan-Kettering Cancer Center with rectal cancer have     an ultrasound at the beginning of their treatment to accurately determine the depth of     penetration (how deep into the rectal wall the tumor goes) and lymph node involvement of     their tumor. This information helps determine the best way to treat the patient's disease.     Three-dimensional TRUS (3-D TRUS) is a new form of ultrasound that gives us all of the     information of traditional ultrasound in addition to being able to view the tumor in     3-dimensions. This image can be stored and analyzed to evaluate the tumor size and volume as     well as determine the unique shape of the tumor. Chemoradiotherapy before surgery is     considered standard of care for most rectal cancers.      Currently, there is no accurate way to determine whether or not the tumor has responded to     the pre-operative radiation therapy. The purpose of this study is to evaluate the response of     rectal cancer to pre-operative chemotherapy and/or radiation therapy using 3-D TRUS to     measure the volume of the tumor before and after chemoradiotherapy.   "
209717|NCT00597623|"     Digital osteoarthritis (DO) which affects the interphalangeal joints and the     Metacarpophalangeal (MCP) of the thumb is a common disease, the prevalence of which increases     with age (36% of the population aged over 70). Certain forms of DO with clinical     manifestations involving inflammatory features are particularly refractory to usual     treatments (analgesics, NSAIDs, braces and local injections). The mechanism of osteoarthritis     involves two major cytokines: interleukin-1 beta and tumor necrosis factor alpha. TNF alpha     is particularly involved in the inflammation process.      The aim of the present study is to study the efficacy of TNF alpha blockers (2 injections of     adalimumab compared to placebo injections in patients with severe and refractory hand     osteoarthritis.      We hope that such new therapeutic option may induce substantial pain relief.   "
209718|NCT00597636|"     The purpose of this study is to help us better understand the cellular changes that may lead     to the development of lung cancer. We want to compare people who have never smoked and yet     have been diagnosed with lung cancer to never smokers who have not developed lung cancer. We     hope to use the information obtained in this study as the basis for future studies and will     not regard the results from this study as final.   "
209719|NCT00597649|"     This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR     (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy     pain due to diabetes in adult outpatients.   "
209720|NCT00597662|"     The purpose of this study is to compare adhesion prophylaxis with     polylactide-caprolactone-trimethylenecarbonate copolymer to icodextrin 4% in terms of safety,     side effects and usability in addition to gaining early evidence of the effectiveness of     polylactide-caprolactone-trimethylenecarbonate copolymer.   "
209721|NCT00597675|"     The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects     who have peanut allergy less allergic and induce changes in their immune system.   "
209722|NCT00597688|"     The purpose of this study is to determine if oral mucosal application of chlorhexidine gel     will prevent the development of ventilator associated pneumonia in children.   "
209759|NCT00598182|"     The objectives of this study are to investigate:        1. the evolution of ADHD symptoms, remission rate of ADHD, social and school function, and          familial relationship;        2. the adherence to CONCERTA, treatment modality, and average treatment duration during the          3-year follow-up period; and        3. the effect of medication on the changes of neuropsychological functioning.   "
209723|NCT00597701|"     The purpose of this study is determine if subjects with alcohol withdrawal who receive oral     baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal     symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with     alcohol withdrawal syndrome(AWS)who receive baclofen plus standard benzodiazepine therapy     will experience fewer complications of AWS (as measured by use of additional sedatives,     restraints, and/or intensive care unit [ICU] admissions) compared with subjects who receive     placebo plus standard benzodiazepine therapy.   "
209724|NCT00597714|"     The central hypothesis of this study is that use of a less toxic chemotherapy preparative     regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell     depletion with alemtuzumab for patients with high risk hematologic malignancies will allow     effective control of disease and improved disease free and overall survival compared with     historical expectations. Specifically, the objectives are to estimate toxicity, disease free,     progression free, event free, and overall survival rates in patients treated with alemtuzumab     T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic     transplantation; evaluate immune recovery following this reduced intensity allogeneic     immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing.   "
209725|NCT00597727|"     The specific aim of this study is to determine if peanut allergen-specific SLIT will cause     clinical desensitization and tolerance to develop in peanut-allergic young children.   "
209726|NCT00597740|"     Purpose of Protocol: The purpose of this study will be to compare the clinical utility of     Propofol sedation with and without the use of the ICU Sedation Protocol. Patients will be     treated according to the attending/consulting preference. No attempt will be made to     influence the patient's routine care and management. The study will compare the average     hourly infusion rates for the Propofol administration, as well as obtain the nursing staffs     evaluation regarding the ease of neurological assessment during each 12 hour shift   "
209727|NCT00597753|"     The purpose of the study was to evaluate the safety and efficacy of peginesatide in the     maintenance treatment of anemia in participants on dialysis.   "
209741|NCT00597935|"     Pelvic organ prolapse is common among women with a prevalence that has been estimated to be     as high as 30%. Pelvic organ prolapse often involves a combination of support defects     involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal     wall is the segment most likely to demonstrate recurrent prolapse after reconstructive     surgery, reoperations are highest among those who require apical suspension procedures with     or without repair of other vaginal segments (12%-33%). Despite the substantial health impact,     there is a paucity of high quality evidence to support different practices in the management     of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle     Training in the Management of Apical Support Loss (OPTIMAL) Trial are:        1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament          suspension (ULS); and        2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in          women undergoing vaginal surgery for apical or uterine prolapse and stress urinary          incontinence.   "
209805|NCT00598819|"     The purpose of this study is to determine whether a new cerebral oxygen monitoring device is     effective and comparatively similar to the current approved devices.   "
209728|NCT00597766|"     This is a double-blinded study of subacromial corticosteroid injection (steroid injection to     the shoulder) to treat shoulder pain in the paralyzed (hemiplegic) shoulder of chronic stroke     survivors. This study is designed to evaluate pain relief of a standard steroid injection     treatment, compared to a high dose treatment and a low dose treatment, for shoulder pain in     stroke survivors. A total of 105 chronic stroke survivors with moderate to severe shoulder     pain will be enrolled. All eligible participants will undergo an initial test injection to     localize pain to the subacromial space. If this turns out to be positive, the subjects will     be randomly assigned to one of three groups:        1. low dose group which receives 20mg of steroid (triamcinolone) injection to the          subacromial space of the affected shoulder;        2. standard dose group which receives a standard 40mg of steroid (triamcinolone) injection          to the subacromial space of the affected shoulder; or        3. high dose group which receives 60mg of steroid (triamcinolone) injection to the          subacromial space of the affected shoulder.      Study participants will all rate their pain in weekly interviews. Laboratory-based measures     also will be administered every 4 weeks. Subjects will be followed for a total of 13 weeks.      The study will thus characterize the dose response of triamcinolone for the treatment of     hemiplegic shoulder pain.   "
209729|NCT00597779|"     The purpose of this study is to compare the clinical and radiological outcome of patients     that are treated with two different orthopedic implants. The study population will consist of     patients that have sustained unstable hip fractures. The two different implants will be     randomly assigned.      The null hypothesis states that there should not be any significant differences between the     two implants.   "
209730|NCT00597792|"     The purpose of this study is to collect post-marketing data on patient outcomes and     satisfaction following treatment with the Plicator™. The outcomes will be tracked through     analysis of patient Quality of Life (QoL) questionnaires and medication use. The QoL and     medication use questionaires will be administered and documented twice before the procedure     and then again at outlined intervals following the procedure. Additionally, financial     measures will be evaluated (i.e. pre-procedural and procedural time and costs,     staffing/personnel needs during procedure, anesthesia and related costs, recovery time and     associated cost, etc.) and post-procedure GERD-related medical history questionnaires will be     completed.      This post-market evaluation is a multi-center study design using the NDO Surgical, Inc.     Plicator as the treatment device. Treatment efficacy will be evaluated by comparing QoL and     medication use before and after treatment with the device. Patient follow-ups will be     completed at 1 week and at 6, 12, 24, 36, 48 and 60 months post treatment.   "
209731|NCT00597805|"     The purpose of this study is to learn more about the personal experiences of patients who are     treated with pelvic exenteration surgery. Pelvic exenteration is a surgical procedure in     which the pelvic organs including the reproductive organs, bladder and/or rectum are removed.     We would like to understand more about the physical, emotional, educational, and sexual needs     of patients who are treated with this surgery. We will use what we learn from this study to     help find better ways of preparing patients for this type of surgery. This will also allow us     to be more helpful to patients' needs after surgery.   "
209734|NCT00597844|"     The purpose of this study is to see how the brain re-learns to control the larynx in speaking     and swallowing when undergoing surgical rehabilitation in the form of either thyroplasty or     vocal fold augmentation for unilateral vocal cord paralysis. What is needed is information on     how the brain re-learns to control speaking and swallowing so that we can eventually learn     how to help patients re-learn faster after their procedure. Functional Magnetic Resonance     Imaging (or fMRI) will allow us to image your brain as you speak and swallow. We will produce     brain maps for speaking, swallowing and hand movements.   "
209735|NCT00597857|"     People experience a wide range of outcomes following a traumatic event. Although rates differ     depending on type of trauma, 20-60% of trauma victims may develop posttraumatic stress     disorder (PTSD). However, not all trauma victims develop PTSD. Previous research has found     that trauma victims who develop PTSD excrete lower levels of urinary cortisol immediately     after a trauma than victims who do not develop PTSD. Other research has suggested that     increasing levels of cortisol may protect against the development of PTSD in patients such as     yourself- but this has not yet been examined. Cortisol is a naturally occurring hormone in     your body, and the present study is designed to test whether increasing cortisol levels can     protect against or decrease symptoms of PTSD. Participants in this study will be randomly     assigned to one of two treatment groups. Participants will receive either hydrocortisone     (20mg, twice per day) or a placebo (a sugar pill) for 10 days with a six-day taper. There is     an equal chance of being in either treatment group, and neither the participant nor the     experimenters will know which treatment was received (except in case of an emergency).   "
209736|NCT00597870|"     The primary objective of this trial is to determine whether the Talent Thoracic Stent Graft,     an investigational device, is a safe and effective method of treating thoracic aortic     aneurysms (abnormal ballooning of the vessel wall) and other thoracic lesions (dissections,     transections, pseudoaneurysms, penetrating ulcers, etc.). The endovascular method is a     substitute for the major operation that is performed to treat the lesions.   "
209737|NCT00597883|"     The purpose of this study is to determine how well patients undergoing carotid endarterectomy     will perform on a battery of tests to assess brain function before and after surgery as     compared to a control group of patients undergoing spine surgery. This study will serve to:     (a) determine incidence of neurologic/neuropsychometric change in patients undergoing carotid     artery surgery, and (b) to ascertain the time it takes for these changes to resolve.   "
209738|NCT00597896|"     The purpose of this study is to examine whether the medication pramipexole (Mirapex) may be     able to improve cognitive problems (i.e. difficulties with thinking, memory, and     concentration) that may be associated with bipolar disorder.   "
209739|NCT00597909|"     The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in     subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).   "
209742|NCT00597948|"     Relatively few health promotion and disease prevention programs have included or targeted     people with disabilities, and even fewer have focused on individuals with intellectual     disabilities.      The long-term objectives of the Healthy Lifestyles for People with Intellectual Disabilities     Study (HLID) are to increase the health of persons with intellectual disabilities by     establishing the efficacy of a health promotion program and promoting its adoption. The HLID     Study is based in the Center on Community Accessibility (CCA) at Oregon Health & Science     University. The mission of CCA is to increase the health and health-related quality of life     of persons with disabilities.      A pilot study conducted by CCA has established the effectiveness of the Healthy Lifestyles     (HL) intervention among a cross-disability population in increasing health behavior adoption.     The specific aim of the HLID Study is to test the efficacy of the HL program specifically     with adults with intellectual disabilities.      The HLID Study uses a randomized control study design. The HL intervention will be     administered to 75 adults and will compare results to those of an additional 75 adults who     receive no intervention. Measurement will include anthropometric assessments to measure     impacts on overweight and obesity, as well as self-report measures of healthy behaviors,     health status, health care utilization, and secondary conditions. Results will be shared with     research participants, presented through professional conferences and newsletters, and     published in peer-reviewed journals with the assistance of community partners.   "
209743|NCT00597961|"     There are two goals of this research study. First, we hope to develop a plan to guide family     discussions that can help parents diagnosed with lung cancer talk about cancer risk with     their adult children. Second, we want to understand how families talk about cancer     prevention.   "
209744|NCT00597974|"     The purpose of this study is to determine how well patients undergoing carotid artery     angioplasty and/or stent-supported angioplasty for the treatment of carotid artery stenosis     will perform on a battery of tests to assess brain function before and after the procedure.     This study will serve as a pilot project: (a) to determine incidence of     neurologic/neuropsychometric change in patients undergoing carotid artery angioplasty and/or     stent-supported angioplasty, and (b) to ascertain the time it takes for these changes to     resolve.   "
209745|NCT00597987|"     The purpose of this study is to collect a blood sample from patients that may be used for     research purposes. These blood samples will be used by researchers at this institution to     study the causes of breast and ovarian cancer, and to better understand how these cancers     develop. We are trying to discover differences in the ways cells work in women with a high     genetic risk of developing breast or ovarian cancer. Early data suggest that some genes may     be turned on or off in different ways based upon whether or not a woman has a high genetic     risk of developing breast or ovarian cancer. The primary objective is to test the hypothesis     that BRCA1 haploinsufficiency regulates gene expression on the X chromosome. This hypothesis     will be tested by comparing the gene expression profiles of BRCA1 heterozygotes (cases) to an     age-matched group of unaffected women who are not BRCA1 mutation carriers (controls).   "
209746|NCT00598000|"     The purpose of this study is to see if different types of surgery for lung cancer have     different effects on quality of life and pain. What we learn from this study may help us find     new ways to improve the quality of life of lung cancer patients who have surgery.   "
209747|NCT00598013|"     The aim of this study was to evaluate the effect of pioglitazone treatment on insulin     secretion, insulin resistance, and progression of atherosclerosis in renal allograft     recipients without preoperative history of diabetes.   "
209748|NCT00598026|"     The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing     mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of     this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits     are scheduled every 3 months. In this context, the recently-introduced remote monitoring     devices constitute a promising new technique, allowing to transmit information about the     status of the device and ICD therapies, without direct contact between patients and     physicians. This monitoring by tele-follow-up might reduce the cost of care by avoiding     useless visits to the implantation centre.      The aim of our study is to assess the cost-benefit ratio of tele-follow-up assisted care as     compared with the conventional ICD follow-up.   "
209749|NCT00598052|"     Recent studies have established the reliability, validity and time course of the cannabis     withdrawal syndrome. This study will investigate the effects of combined treatment of     Escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana     withdrawal syndrome in regular chronic users of marijuana. We predict that combined     pharmacological treatment and cognitive-behavior therapy will help patients to abstain from     using using marijuana and it will alleviate their marijuana withdrawal symptoms.   "
209750|NCT00598065|"     The purpose of this study is to see if researchers can improve the detection of lung cancer     by using a new method which will help us to take multiple snapshot images of the lungs while     the patient is breathing. We are also investigating whether with the help of this new method     we can better measure the actual amount of radioactivity that is taken up by the cancer. The     name of this new method is respiratory gated PET/CT. Previous research has shown that PET     scans may be useful in investigating whether cancer has spread to other parts of the lung or     body. Using our standard method, smaller cancers are sometimes difficult to detect in the     lungs because the PET images are taken over several minutes and the patient is breathing     during that time. That means the cancer may appear blurred on the images (like a poor     photograph) or may not be identified at all. In this study, in addition to the images that     were ordered by your doctor, we will take additional images of your lungs while you are     following a breathing command (breath in-hold-breath out). We will then compare the images     of your cancer during the regular PET study with those taken during the breathing commands.      The hypotheses to be tested in this pilot study are:        1. Respiratory gated image acquisition reduces partial volume effects on PET image that may          render lung lesions undetectable.        2. Breath-hold CT may detect small lung lesions that are beyond the limit of detection in          shallow-breathing CT scans, related to respiratory motion which causes blurring          artifacts around smaller lung lesions.   "
209751|NCT00598078|"     To determine the relationship between drug plasma levels and safety, tolerability and     efficacy in patients with essential tremors after dosing with Sodium oxybate   "
209752|NCT00598091|"     The purpose of this study is to find the highest dose of the drugs gemcitabine and dasatinib     that can be given for the treatment of pancreatic cancer. Gemcitabine (also called Gemzar™)is     a drug that is given intravenously. Dasatinib (also called Sprycel™) is a tablet and will be     taken by mouth.      Gemcitabine is approved by the Food and Drug Administration (FDA) for the treatment of     advanced breast, lung and pancreatic cancer. Dasatinib is approved by the FDA for the     treatment of chronic myeloid leukemia (CML), acute lymphoblastic leukemia or for patients     that are resistant to imatinib mesylate (Gleevec™ ).      This study will try to find the highest doses of these drugs that can be tolerated when taken     in combination. The study will also look at how the drugs work in the body, and will see if     there is any effect on pancreatic cancer.   "
209753|NCT00598104|"     This study will evaluate the safety and efficacy of QAX576 against asthma attacks in adults     with moderate persistent allergic asthma   "
209754|NCT00598117|"     The goal of this study is to evaluate how treatment for esophageal cancer affects your     quality of life. The findings of this study may help us understand how this disease and its     treatment affect your lifestyle, diet, exercise, support system and overall quality of life.     We hope this study will provide important information that can be used to develop programs to     improve the quality of life of patients with esophageal cancer.   "
209755|NCT00598130|"     This is a prospective, randomized, single blind, standard care- controlled study, which will     include a total of 30 patients divided into two treatment arms: First are: patents who will     be treated in accordance with standard of care. Second arm: patients for which the Fibrin     Fleece will be applied directly on the active bleeding site.   "
209756|NCT00598143|"     Doctors at MSKCC are doing this research study to see if smokers are interested in the idea     that genes might be markers of cancer risk, and to see if smokers would want to learn this     information about their risk if it were available.      Different versions of the gene called UGT1A7 are found in different people. Certain versions     of this gene can increase the risk of cancer in people. In this study, doctors will determine     the different types of UGT1A7 in smokers and find out whether smokers show good interest and     understanding. The information from this study will be used in future studies to identify     smokers at increased risk for cancer, and to help smokers quit.   "
209757|NCT00598156|"     Chemotherapy and bevacizumab is given for 4 months. Patients who have not progressed will     continue with maintenance treatment with either bevacizumab (Avastin) alone, or bevacizumab     and erlotinib (Tarceva).   "
209758|NCT00598169|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy,     such as dexamethasone, ifosfamide, carboplatin, and etoposide, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. It is not yet known whether giving     bortezomib together with combination chemotherapy is more effective with or without rituximab     in treating AIDS-related non-Hodgkin lymphoma.      PURPOSE: This clinical trial is studying giving bortezomib together with dexamethasone,     ifosfamide, carboplatin, and etoposide to see how well it works with or without rituximab in     treating patients with relapsed or refractory AIDS-related non-Hodgkin lymphoma.   "
209775|NCT00598403|"     The main objective of the study is to comparatively assess the efficacy and tolerability of     the drugs under study in the treatment of acute uncomplicated cystitis.   "
209760|NCT00598195|"     What are the pharmacokinetics of ketamine in infants and children requiring ketamine for     induction of anesthesia for cardiac surgery that requires CPB? Specific Aim 1: To determine     the pharmacokinetic parameters of a single intravenous bolus dose of ketamine in infants and     children undergoing cardiac surgery with and without CPB (cardio-pulmonary bypass).      Specific Aim 2: To describe the disposition of ketamine's primary active metabolite,     norketamine,following a single intravenous bolus dose of ketamine in infants and children     undergoing cardiac surgery with and without CPB.      Specific Aim 3: To determine the relationship between ketamine and norketamine     pharmacokinetic parameters and age as well as CPB time.   "
209761|NCT00598208|"     The primary objective of this trial is to investigate the dose -response relationship of a     single injection of Org 38286 to initiate multifollicular growth for the first seven days in     a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.   "
209762|NCT00598234|"     We propose that administration perioperative celecoxib is effective to control postoperative     VAS pain scores, improve rehabilitation results, and decrease narcotics usage in total knee     replacement patients.   "
209763|NCT00598247|"     This study uses the drug PPX (also called Xyotax and CT-2103) in women with advanced     colorectal cancer. PPX is an experimental drug that has not been approved by the Food and     Drug Administration (FDA). PPX has been shown in the laboratory and in studies in humans to     cause some cancer cells to die and some tumors to shrink. Women in some studies with PPX have     been shown to live longer than the men that receive the drug. Some studies in humans suggest     that estrogen (a hormone found in women) may protect women from getting colorectal cancer and     allow women that do get colorectal cancer to live longer than men that do.      The purpose of this study is to see if women with colorectal cancer and a certain level of     estrogen experience tumor shrinkage after they receive the drug PPX. This study will also     study genes (genes are the cell's blueprint) in participant's tumors and in their blood.     Several genes can affect how people's bodies react to the cancer drugs. We want to see if     these predict response to the study drugs.   "
209764|NCT00598260|"     This is a prospective randomized cohort study of obstetric patients from Paley clinic at AEMC     and from other affiliated obstetric clinics.      This study will try to determine if active management of risks in pregnancy at term by     inducing patients will not decrease the cesarean delivery rate or change neonatal outcomes.      The outcomes that will be measured include cesarean delivery rate, meconium, Apgar scores and     admissions to the NICU.   "
209806|NCT00598832|"     The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in     the treatment of Acne Vulgaris.   "
209767|NCT00598299|"     Human serum eye drops have been successfully used in the treatment of severe ocular surface     disorders and the enhancement of corneal wound healing. Umbilical cord serum is also proven     to be effective in treatment of dry eye and persistent corneal epithelial defects. However,     there are limited studies comparing the corneal epithelial wound healing promoting effects     between these two blood derived products. The purpose of this study is to test the corneal     epithelial wound healing promoting effects between auto serum and human cord blood serum.     Primary cultured bovine corneal epithelial cells were used as the model to investigate wound     healing, cell proliferation and migration by means of scratch corneal wound healing assay     evaluation, MTS assay and Boyden chamber migration assay in response to human serum and     umbilical cord serum. The concentrations of EGF, TGF-β1, and fibronectin were also compared     between human serum and umbilical cord serum with ELISA kits.   "
209768|NCT00598312|"     The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for     Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients     with prostate cancer.   "
209769|NCT00598325|"     Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for     anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule     so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether     changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating     antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1     adds a 6th dose at week 26, and extends follow-up through week 52.   "
209770|NCT00598338|"     The purpose of this study is to determine whether prucalopride is safe and effective in the     re-treatment of chronic constipation.      Hypothesis:      Retreatment is as effective and safe as treatment with prucalopride in patients with chronic     constipation.   "
209771|NCT00598351|"     This study will examine over the long-term the progress of patients with neurofibromatosis     Type 2 (NF2), a condition associated with tumors of the nerves, brain and spinal cord. It     will study patients tumors to learn how fast they can grow and if certain factors might     affect their growth. It will also examine the effects of the tumors on patients abilities to     carry out activities of daily living.      People between 8 and 75 years of age with NF2 may be eligible for this study. Participants     undergo the following procedures:      Initial evaluation, including hearing, eye and balance testing, gait (walk) testing, magnetic     resonance imaging (MRI) scans of the brain and spine, blood tests, and physical and     neurological examinations.      MRI scans of the brain and spine every 6 months to follow the size and number of tumors.      Physical and neurological examinations and blood tests every 6 months.      Auditory tests every 12 months. These tests evaluate middle and inner ear function and the     patient s ability to hear tones at different frequencies and to hear words at different     volumes. The subject responds to tones and words that are delivered through earphones.      Eye examination every 1 to 2 years.      Gait testing every 12 months if a spinal cord tumor causes problems with sensation or muscle     control in the arms and legs Subjects joints are measured while they walk across a room     several times as scientific cameras record their movements.      Vestibular testing if the patient experiences changes in balance or undergoes treatment for     vestibular schwannoma (a tumor that develops on the hearing and balance nerves). These tests     check the function of various components of the balance system (eyes, inner ear, or leg and     body sensation and muscles). They include:        -  Videoelectronystagmogram Tracks subjects eye movements while they follow moving red          lights with their eyes.        -  Vestibular evoked myogenic potential Assesses subjects neck muscle movements in response          to noise.        -  Posturography Determines which parts of the balance system the subject relies on most.          Subjects stand on a platform and try to maintain their balance while changes are made to          the platform and the environment.        -  Rotary chair test Subjects eye movements are monitored as they follow red spots and          strips of light with their eyes while seated in a rotary chair that turns side to side          at several speeds.   "
209772|NCT00598364|"     The purpose of this study is to evaluate how common gene mutations are in benign and     malignant thyroid lesions.   "
209773|NCT00598377|"     We aimed to evaluate the hypothalamus-pituitary-adrenal axis in autosomal dominant polycystic     kidney disease (ADPKD) patients. Twenty two ADPKD patients and 27 healthy subjects were     enrolled.   "
209774|NCT00598390|"     The purpose of this protocol is to measure brain CB1 receptors in the hope to better     understand how they work, so that one day we can understand how the CB1 receptors are     involved in psychiatric, neurological, and behavioral disorders.   "
209776|NCT00598416|"     The proposed project will apply a unique, effective family-responsive psychoeducation     program, PsychoEducation Responsive to Families (PERF), for Hepatitis C Virus (HCV)     treatment. The goal is to demonstrate that the intervention will enlarge the eligibility of     some patients for HCV treatment and help sustain others through it.   "
209777|NCT00598429|"     This pilot study was a randomized, placebo-controlled, clinical trial to test the safety of     using the intravenous form of Prostaglandin E1 (PGE1) in an inhaled form for treatment of     hypoxemic respiratory failure in term newborns. The study planned to enroll 50 infants     diagnosed with hypoxemic respiratory failure at nine NICHD Neonatal Research Network sites,     and randomly assign them to receive one dose over a 72-hour period of either high     concentration PGE1 (300 ng/kg/min), low concentration PGE1 (150 ng/kg/min), or placebo     (normal saline, the diluent for the drug). In addition to determining the safety, optimal     dose, and duration of the therapy, this pilot trial planned to evaluate the feasibility of     conducting a larger, multi-center randomized, blinded placebo-controlled trial.   "
209778|NCT00598442|"     The purpose of this study was to evaluate the safety and efficacy of peginesatide for the     treatment of anemia in participants with chronic kidney disease, who are not on dialysis and     not on erythropoiesis stimulating agent (ESA) treatment.   "
209779|NCT00598455|"     Eighty percent of patients with tuberous sclerosis complex (TSC) have renal angiomyolipomata.     These lesions grow and can lead to significant morbidity by hemorrhage or renal failure.     Understanding the natural history of these lesions and understanding which lesions may be     more prone to grow quickly or develop aneurysms that predispose to hemorrhage will greatly     assist clinical care of patients with TSC. The objective is to test the hypothesis that     serial MR and CT imaging will allow objective, reproducible quantification of angiomyolipoma     growth by volumetric analysis, and analysis of lesions characteristics will identify     angiomyolipomata with rapid growth potential that would require intervention. The specific     aim of this proposal is to collect clinically obtained serial abdominal imaging from the     Tuberous Sclerosis Natural History Consortium Centers and analyze the volume and adiposity of     the individual angiomyolipomata. The growth rate is hypothesized to have an inverse     relationship to adiposity. Yearly renal MR or CT imaging will be performed of patients with     TSC. The images will be coded at the site of acquisition, and transferred via VPN to a secure     server at Cincinnati Children's Hospital Medical Center. Using innovative imaging processing     software (Cincinnati Children's Hospital Image Processing Software (CCHIPS), the image data     will be segmented to reveal various tissue components based on signal intensities. Different     signal intensities can differentiate normal renal parenchyma, and renal angiomyolipomata.     Using the imaging data and the novel software, the volume of an individual angiomyolipoma, as     well as the adiposity will be determined. Imaging at enrollment (year 1) will serve as     baseline. At years two and three, the lesions will undergo repeat analysis. Angiomyolipoma     growth rates and adiposity over three years will be analyzed to test the hypothesis above.   "
209780|NCT00598481|"     This is a phase I/II protocol to evaluate the safety and efficacy of ADA gene transfer into     hematopoietic stem/progenitor cells for the treatment of adenosine deaminase     (ADA)-deficiency. This condition is an autosomal recessive form of Severe Combined     Immunodeficiency (SCID) characterized by impaired immune responses, recurrent infections,     failure to thrive and systemic toxicity due to accumulation of purine metabolites.     Transplants from an HLA-identical sibling donor is the treatment of choice, but available for     a minority of patients. The use of alternative bone marrow donors or enzyme replacement     therapy is associated with important drawbacks. The drug product studied in this protocol     consists of autologous CD34+ hematopoietic stem/progenitor cells engineered ex vivo with a     retroviral vector encoding the therapeutic gene ADA. The engineered CD34+ cells are infused     following a nonmyeloablative conditioning with busulfan to make space in the bone marrow. The     study objectives are: a) to evaluate the safety and the clinical efficacy of gene therapy, in     the absence of enzyme replacement therapy; b) to evaluate the biological activity     (engraftment, ADA expression) of ADA transduced CD34+ cells and their hematopoietic progeny.     c) to evaluate the immunological reconstitution and purine metabolism after gene therapy.   "
209781|NCT00598494|"     The purpose of this research sub-study is to determine the changes in heart function during     the bedrest period using ultrasound and MRI. This topic is important for medical care of     astronauts in space. It can enable physicians on the ground to monitor exercise protocols     that are used to prevent deconditioning-loss of strength during long space flights.      Your participation in this study would include ultrasound examinations with bicycle exercise     before, during, and after the 12-week bedrest period. MRI exams would be performed before and     after the bedrest period.      Each echo exam may last up to 1 hour. This time will be required to perform an ultrasound     examination before and during supine (lying down) bicycle exercise. The exercise period will     be approximately 10-15 minutes. The bicycle exercise will be a symptom-limited test. This     means that the test will be stopped if you experience any discomfort. An ultrasound     examination of your heart will be done to assess heart function. You will be asked to lie on     your left side on an examination table while a technician takes pictures of your heart with a     small probe that is gently pressed against your chest after applying a gel. The ultrasound     data will be processed to evaluate myocardial strain, a value that may be useful in     describing heart function.      Each MRI may last up to 1 hour. An MRI obtains body pictures created by using magnetic energy     rather than x-ray energy. To have the scan, you will lie on a table that slides into the     scanner, which is like a large tube. An MRI examination of your heart will be done to assess     heart function. You will be asked to lie still and follow simple breathing instructions     during the procedure. The MRI data will be processed to evaluate the volume of blood being     pumped by your heart, a value that may be useful in describing heart function.   "
209782|NCT00598507|"     The purpose of this study is to find out how effective an investigational drug named ZK-Epo     is against melanoma. Although ZK-Epo has been studied in the treatment of cancer, it is not     approved for use in treating melanoma. This research is being done because currently there     are only a limited number of treatment options for patients who have melanoma that has spread     to distant organs.      We expect each patient to be in this study for at least 2 cycles. One cycle lasts for 21     days. If their tumor does not grow after 2 cycles and they do not have any major     side-effects, they may receive up to 6 cycles of ZK-Epo.      If after they have received 6 cycles of ZK-Epo and their doctor determines that the tumor is     continuing to shrink, they will continue treatment with ZK-Epo. The number of treatments the     patient receives after 6 cycles will depend upon when their doctor feels there has been     maximum tumor response (tumor shrinkage). Two treatments will be given beyond what their     doctor considers the point of maximum shrinkage. We estimate that they will spend anywhere     from 1 1/2 months to 5 months taking part in this study.   "
209783|NCT00598533|"     The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting     stents for the reduction of Coronary Restenosis   "
231996|NCT00889031|"     The purpose of this study is to collect a blood sample in patients with Chronic Lymphocytic     Leukemia (CLL).   "
209784|NCT00598546|"     The purpose of this study is to find out how you feel about the quality of your life after     having had surgery to remove your stomach tumor. Some patients continue to experience     different problems after stomach surgery, even when the surgery was more than three years     ago. The purpose of this study is to find out the specific things that may continue to affect     patients' quality of life after a major operation.   "
209785|NCT00598559|"     The study will be investigating safety and efficacy administration of repeated dose of IV     Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult     patients.   "
209786|NCT00598572|"     Animal studies show that the breakdown of blood results in iron accumulation in the brain     after brain hemorrhage (ICH); and that iron plays a role in brain injury in ICH patients.     Deferoxamine (DFO) has been extensively used in clinical practice for more than 30 years to     remove excessive iron from the body, and has been shown to provide some benefit in animal     studies of ICH. Therefore, we plan to undertake this study to evaluate the safety and     tolerability of treatment with DFO in patients with ICH, and to determine the maximal     tolerated dose to be used in future studies to determine if treatment with DFO can improve     the outcome of patients with ICH.      Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of DFO,     by determining the treatment related adverse events, in patients with ICH; and 2) to     determine the maximal tolerated dose to be adopted in subsequent studies to test the efficacy     of DFO in improving outcome after ICH.      We hypothesize that DFO is well-tolerated and has minimal serious adverse effects in patients     with ICH; and that treatment with DFO will improve patients' outcome. The results can     potentially bring into account new means to improve the outcome of patients with ICH. ICH is     a frequent cause of disability and death. A successful study demonstrating the efficacy of     iron-modifying therapy would be of considerable public health significance.   "
209787|NCT00598585|"     Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)   "
209807|NCT00598845|"     The purpose of this prospective multicenter trial is to investigate the value of molecular     markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation     to treatment.   "
209830|NCT00599144|"     Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine     soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.   "
209788|NCT00598598|"     The National Space Biomedical Research Institute is interested in learning more about heart     function in space. One potential problem with long duration, manned space flight is muscle     loss- including loss of heart muscle. One goal of our research is to help identify why this     muscle loss occurs. We are interested in patients undergoing aortic valve surgery because     this procedure is performed to correct a problem with the valve that may also change heart     function. This change in heart function may provide information that is useful in     understanding and potentially preventing the loss of cardiac muscle in space.      Three patient groups will be studied, patients having surgery for aortic regurgitation,     aortic stenosis, and coronary bypass. We are planing to perform this study on 30 patients, 10     in each group.      The aim of this study is to continue our ongoing study of the magnitude and predictors of the     changes in size of the left ventricle following acute volume and pressure unloading as a     ground-based analog for manned space flight.   "
209789|NCT00598611|"     The purpose of this study is to compare urticaria lesions (size, kinetics) by thermography,     volumetry and digital time lapse photography in CU patients treated with desloratadine 5 mg     or desloratadine 20 mg. Hypothesis: Updosing of desloratadine (20mg) is more efficient in the     treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).   "
209790|NCT00598624|"     This is a multicentric, non-randomized, non-controlled open-label phase II trial to evaluate     the safety and efficacy of treosulfan in a combination regimen with fludarabine as     conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with     haematological malignancies.      The aim is to demonstrate a clinical benefit compared with historical data on intravenous     busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication     conditioning before allogeneic stem cell transplantation.   "
209791|NCT00598637|"     The purpose of this study is to evaluate the efficacy of two different drug-eluting stents     (Everolimus and Zotarolimus-eluting) for treatment of unprotected left main coronary artery     disease.   "
209792|NCT00598650|"     The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with     Dementia with Lewy Bodies (DLB).   "
209793|NCT00598663|"     The primary objective of this study is to evaluate whether the patients with Type 1 diabetes     mellitus in sub-optimal glycemic control can achieve better glycemic control by using the     Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus     the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose     (SMBG).Our null hypothesis is there is a 0% reduction in HbA1c from baseline compared to     control group, after 6 months of treatment.   "
209794|NCT00598676|"     The aim of this study is to determine whether biodegradable polymer based rapamycin-eluting     stent performs equal to permanent polymer based everolimus- and rapamycin-eluting stents     regarding reduction of adverse cardiac events at one year.   "
209795|NCT00598689|"     GenTeal gel is an artificial tear gel used to lubricate the surface of the eye. This study     will evaluate the effect of GenTeal gel on comfort following LASIK surgery. Participants will     be asked to come to the clinic for three regularly scheduled visits after LASIK surgery: Day     1 (one day after LASIK surgery), Day 7 (one week follow-up), and Day 30 (one month     follow-up). Participants will be asked to complete a questionnaire regarding eye comfort     during each follow up visit. Participants will be randomly assigned to one of two groups, one     of which will receive Genteal Gel four times a day for five days prior to surgery. The other     group will receive no preoperative gel or lubricant, which has been our standard approach for     many years.   "
209796|NCT00598702|"     Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when     administered at a daily dose of 40 to 75 mg/kg body weight   "
209797|NCT00598715|"     For lesions which develop restenosis after a drug-eluting stent, it is not known which the     right strategy to use is, implantation of the same type of DES as the initial one or a DES     with a different drug.   "
234375|NCT00925275|"     The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry     and pharmacokinetics of I-131-CLR1404.   "
209798|NCT00598728|"     The purpose of this study is to collect information on the long-term side effects of     treatment for Hodgkin Lymphoma. We hope to study about 500-800 survivors of Hodgkin Lymphoma.     We plan to use the findings from this study to better understand Hodgkin Lymphoma survivors'     health and quality of life.   "
209799|NCT00598741|"     The purpose of this study is to see whether fast imaging with MRI and the usual contrast     material used for MRI, predicts which patients will do well with treatment. Some studies     suggest that MRIs done right before surgery may be able to tell how much of the cancer was     killed by the chemotherapy. This study will see if this is true in patients with osteogenic     sarcoma (OS) and Ewing's sarcoma (ES). This study will also see if MRIs done early in     treatment can tell if the chemotherapy is working.   "
209800|NCT00598754|"     The purpose of this study is to perform ground-based research to study what happens to the     heart muscle in space. People who have problems with their aortic valve have an increase in     the amount of muscle in the left ventricle of the heart. After valve surgery, the amount of     muscle should decrease and return to normal. Astronauts lose heart muscle mass during space     flight. Our study will look at these changes in your heart, which we believe are similar to     what happens during long term space travel.      This study will look at the accuracy of three dimensional ultrasound imaging (echo) in     monitoring the changes in heart size and function following aortic valve replacement. We are     studying ways to prevent health-related problems that men and women will face on     long-duration space missions.      The hypothesis is that serial two dimensional and three dimensional echo will show accurate     changes in the left ventricle mass and volume following aortic valve replacement for aortic     stenosis or regurgitation   "
209801|NCT00598767|"     NASA has outlined the most urgent threats to life and health in manned spaceflight. One of     the threats is the risk of trauma and acute medical problems. One of the most important     provisions of acute and chronic medical services in space is the availability of high quality     diagnostic imaging with the potential for either ground based or onsite interpretation. The     principle diagnostic imaging modality for space crew use in space will be ultrasound. The aim     of the study is as follows:      -To use state of the art 3 dimensional CT scanner to acquire images for segmentation and     registration supplying a template to judge physiologic or pathologic changes observed in     space with 3D ultrasound   "
209802|NCT00598780|"     To evaluate over a period of 6 months the safety and the treatment satisfaction of newly     prescribed levocetirizine in patients of age ≥ 2 years with persistent allergic rhinitis.   "
209808|NCT00598858|"     This pilot phase II trial studies docetaxel and prednisone in treating patients with newly     diagnosed stage I-II prostate cancer undergoing prostatectomy. Drugs used in chemotherapy,     such as docetaxel, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Biological therapies, such as     prednisone, may stimulate the immune system in different ways and stop cancer cells from     growing. Giving docetaxel and prednisone together may kill more tumor cells.   "
209809|NCT00598871|"     As a consequence of damage to multiple organ systems throughout the course of their disease,     diabetic patients suffer a number of chronic complications giving rise to increased     morbidity, mortality, and health care costs specific to this population. Within the     ophthalmic domain, diabetic retinopathy (DR) frequently induces serious visual impairment.     Although DR can be addressed surgically, surgery remains a less than ideal intervention     within this population with a well-characterized compromised ability to heal. The     introduction of a therapeutic agent that could accelerate wound closure and decrease healing     time, thereby reducing the risk and incidence of infection and corneal scarring in these     susceptible patients, would represent a significant clinical and pharmacoeconomic advance in     the treatment of this condition.   "
209810|NCT00598884|"     This study will evaluate the effectiveness of an Internet-based self-help program in treating     people who are at risk for developing prolonged grief disorder following a recent loss.   "
209811|NCT00598897|"     To determine the safety and tolerance of clarithromycin given three times per week in     combination with multiple drugs including rifabutin three times per week   "
209812|NCT00598910|"     Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the     lipid are decrease due to HAART treatment   "
209813|NCT00598923|"     Our hypothesis is that topiramate will reduce acute seizures after traumatic brain injury and     will help prevent the development of epilepsy after traumatic brain injury.   "
209814|NCT00598936|"     The purpose of this study is to determine whether a new cerebral oxygenation monitoring     device is comparatively similar to the current approved devices.   "
209815|NCT00598949|"     The purpose of the study is to determine genetic links among blood-relatives and between     spouses of patients with pituitary tumors.   "
209816|NCT00598962|"     To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three     times weekly in the treatment of lung infection with M. avium complex(MAC)   "
209817|NCT00598975|"     Study 07-PIR-02 is a Phase 2 study designed to evaluate the safety and efficacy of NKTR-102     (PEG-irinotecan) for the treatment of patients with colorectal cancer (CRC). The study is     comprised of two sequential components - Phase 2a and Phase 2b. The Phase 2a portion is an     open-label, dose-finding trial in multiple solid tumor types that are refractory to standard     curative or palliative therapies. The primary endpoint of the Phase 2a is to establish the     /recommended Phase 2 Dose (RPTD) of NKTR-102 by measuring the frequency of Dose Limiting     Toxicity (DLT). The Phase 2b portion is an open-label, randomized, two-arm study in patients     with second-line metastatic colorectal cancer and study participants will be randomized (1:1)     to receive either NKTR-102 and cetuximab or irinotecan and cetuximab. The primary endpoint of     the Phase 2b portion of the trial is progression-free survival. Secondary endpoints for both     the Phase 2a and 2b portion include response rate, response duration, overall survival,     standard pharmacokinetics, and incidence of toxicities, including diarrhea and neutropenia.   "
209818|NCT00598988|"     The purpose of this study is to investigate feasibility issues related to conducting an     acupuncture study in a population of adolescents and young adults with infectious     mononucleosis. Additionally, this study will provide preliminary data regarding treatment     parameters (acupuncture and standard care) and outcomes (i.e. fatigue).   "
209819|NCT00599001|"     The main purpose of this study is to assess the safety, tolerability, and biological activity     of SD-101 compared with placebo in healthy male volunteers.   "
209820|NCT00599014|"     Heart failure is a very common cause of hospital admission and there are half a million new     cases diagnosed each year in the United States. While some important progress has been made     over the last two decades for the treatment of heart failure, there still remains a critical     need for further advances in our understanding of this disease in order to significantly     improve patient outcomes. Large numbers of heart failure patients need to be studied over     time to allow scientists to investigate those factors that influence the responses to     therapy.   "
209821|NCT00599027|"     The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate     nasal spray) in comparison with placebo in improving the quality of life of subjects with     moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary     objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of     allergic rhinitis and asthma.   "
209822|NCT00599040|"     The purpose of this study is to determine if what you eat affets your insulin sensitivity     when you lose a small amount of weight   "
209823|NCT00599053|"     Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very     low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the     proinflammatory state caused by infection that puts them at risk for Bronchopulmonary     Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age)     treatment with intravenous azithromycin versus expectant management for VLBW infants with     Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine     microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for     eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of     infants in the two treatment groups and those without respiratory tract Ureaplasma spp.     infection   "
209824|NCT00599066|"     The purpose of this study is to learn more about an Entropy monitor that the anesthesiologist     will be using.   "
209825|NCT00599079|"     To determine the safety and efficacy of azithromycin in the treatment of lung infection with     M.avium complex and M. abscessus lung disease.   "
209826|NCT00599092|"     The purpose of this study is to observe predictors of pituitary tumor recurrence and markers     of persistent disease activity in patients harboring pituitary mass lesions of all types.   "
209827|NCT00599105|"     This study will investigate the association of angiogenesis in breast cancer measured by     magnetic resonance imaging and biomarkers with long-term prognosis of patients.   "
209831|NCT00599170|"     The use of R-CHOP, given every two weeks, will be associated with improvements in response     rate, and progression-free survival, when compared to R-CHOP given every three weeks. The     addition of sargramostim will allow safer adminIstration of the dose-intensified R-CHOP,     while at the same time, improving the functional capability of the macrophages, and thus     increasing the likelihood of improved clinical response and disease-free survival.      The current phase II study is being proposed in order to develop preliminary data on the     efficacy and toxicity of this approach, for future study in larger, phase III randomized     trials. Laboratory correlates of response will also be studied, including activation markers     on monocytes/macrophages before and after sargramostim exposure; and presence or absence of     informative Fc gamma III polymorphisms.   "
209832|NCT00599183|"     This is an investigator-iniated pilot study to determine if MRI with diffusion tensor imaging     (DTI) and tractography will yield useful information in patients suspected of having cervical     spine disc herniation to provide imaging confirmation of whether or not disease is     progressing and to assess response to treatment (regardless of treatment provided).   "
209833|NCT00599196|"     The objective of this open-label extension is to assess the safety and tolerability of     long-term treatment of the rotigotine patch in subjects with early-stage idiopathic     Parkinson's disease   "
209834|NCT00599209|"     The magnitude and intensity of medication use among our nation's 1.6 million nursing home     residents matches or exceeds that of hospitalized patients. The residents of nursing homes     are among the most frail patients in the population; the challenges of using medications in     this setting are great, not only because of the physiologic declines and pharmacologic     changes that occur with aging, but also because of the special clinical and social     circumstances that often characterize nursing home care. In our previous research, we have     determined that medication errors resulting in adverse drug events occur most often at the     ordering and monitoring stages of pharmaceutical care. Clinical decision-support systems are     clinical consultation systems that combine individual patient information with population     statistics and scientific evidence to offer real-time information to health care providers.     These systems have been found to improve the quality of medication prescribing in the     hospital setting. In this study, we intend to determine the extent to which a computer-based     clinical decision-support system (accompanying computerized provider order-entry) can improve     the quality of medication ordering and monitoring for residents in the long-term care setting     through a randomized trial. We will track the costs associated with this system and the     system's impact on the productivity of providers. We will also assess the culture of U.S.     nursing homes and the organization of the nursing home setting with respect to readiness to     incorporate computerized provider order-entry with computer-based clinical decision support.     Our project addresses specific areas that are of particular interest to AHRQ with special     relevance to the delivery of high-quality care to a priority population--the frail elderly     patient population residing in nursing homes. The project will assess the economic     implications of health information technology in the nursing home environment that will be of     interest to key stakeholders, including physicians, pharmacists, nurses, payers,     policymakers, the nursing home industry, and pharmaceutical vendors to long-term care     institutions.   "
209835|NCT00599222|"     Neovascular age-related macular degeneration (AMD) is the leading cause of severe vision loss     in the Western world. Intravitreal ranibizumab has recently become the treatment of choice     for neovascular (AMD). Limitations to ranibizumab however include the high cost for the drug     and the need for frequent intravitreal re-injections. The investigators' hypothesis is that     when ranibizumab is combined with transpupillary thermotherapy (TTT) the number of necessary     retreatments with Lucentis will be significantly reduced as compared to ranibizumab alone.   "
209836|NCT00599235|"     Hypertension (persistently elevated blood pressure) is a major risk factor for heart disease     and stroke. Hypertensive individuals show a reduced exercise capacity, which is present from     a very early stage and contributes to their increased cardiovascular risk. Sildenafil belongs     to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, and it works by     enhancing the effects of nitric oxide, a substance that dilates blood vessels and increases     blood flow. We hypothesize that sildenafil, because of its effect on nitric oxide and blood     flow, will improve exercise capacity in hypertensive patients. Therefore, the main aim of the     study is to investigate the effects of PDE5 inhibition on exercise capacity and vascular     function in hypertension, and to compare these effects in hypertensive patients and healthy     controls.   "
209837|NCT00599248|"     The study is being conducted to investigate the safety and activity of TissueGene-C injected     into the knee joint of patients with chronic degenerative joint disease (DJD) who will be     undergoing total knee replacement.   "
209838|NCT00599261|"     To determine the effect of scar tissue removal on the rate of infection and any other     complications such as bleeding in patients with an ICD or pacemaker who have the device     generator or leads replaced or repositioned.   "
209839|NCT00599274|"     The purpose of this study is to find out if weekly Avonex works as well as three times a week     Rebif in subjects with relapsing multiple sclerosis.   "
209840|NCT00599287|"     The purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled,     doubleblind clinical trial to investigate the use of methylphenidate, rivastigmine or     haloperidol in hypoactive ICU-delirium. In addition we will compare duration of delirium,     severity of delirium, length of ICU/hospital stay and side effects between the different     interventions.   "
209841|NCT00599313|"     The purpose of this research study is to find out what effects (good and bad) Sutent has on     you and your prostate cancer.   "
209842|NCT00599326|"     To determine the efficacy and tolerability of deferasirox in the treatment of Porphyria     Cutanea Tarda.      Primary objective - the elimination of all blistering within 6 months of treatment.      Secondary objective - decrease in total body iron levels.   "
209843|NCT00599339|"     This study will be conducted in an observational multiple-cohort design aimed at acquiring     clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD)     will be enrolled.   "
209844|NCT00599352|"     The purpose of this study is to determine how common low levels of magnesium are in patients     with end stage liver disease. In addition, investigator is trying to determine if low levels     of magnesium affect the release of parathyroid hormone in patients with end stage liver     disease and low vitamin D levels   "
209845|NCT00599365|"     The purpose of this study is to see if a pharmacist can help patients understand how he/she     should be taking their medications. The study is also being done to see if meeting with the     pharmacist can help patients better control chronic kidney disease and the medical problems     that can occur.   "
209846|NCT00599378|"     To assess the efficacy of a novel prompting intervention based on the concept of     implementation intentions.   "
209847|NCT00599391|"     Renal failure or kidney failure is a situation in which the kidneys fail to function     adequately. It is divided into acute and chronic forms; either form may be due to a large     number of other medical problems.   "
209848|NCT00599404|"     Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400     tablets from the same drug product batch.   "
209849|NCT00599417|"     Primary      - To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma     after second period of treatment      Secondary        -  To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract          infections symptoms through patient evaluation of fever or respiratory presence after          second period of treatment        -  To evaluate loss of working or study days after second period of treatment        -  To evaluate the safety and tolerability of Pulmonarom in the population under study   "
209850|NCT00599430|"     The aim of the present prospective study is to investigate whether the consumption of certain     probiotic strains over a six-month winter/spring season would be able to affect the incidence     and duration of upper respiratory tract infections, in otherwise healthy children as well as     determining whether a combination of two strains would perform differently from a single     strain version.   "
209851|NCT00599443|"     A controlled, double blinded study to determine the safety and reactogenicity in healthy     adults of a single dose of a trivalent cell-derived influenza vaccine administered by     intramuscular injection.   "
209852|NCT00599456|"     Hot flashes can be a disturbing symptom of menopause. Prescription medications are commonly     used for symptom relief. Several non-prescription therapies are under investigation. This     study will examine the use of omega-3 (fish oil) supplements to see if it helps relieve hot     flashes and therefore improve the quality of life.      Study Hypotheses:      Menopausal women who take Omega 3 vitamins(fish oils)will show improvement in the severity of     their hot flashes.In addition women who take Omega 3 supplements will show improvement in     their lipid profiles.   "
209853|NCT00599469|"     Alzheimer's disease is a progressive and fatal brain disease. This study will investigate the     use of far infrared radiation treatment for the disease.   "
209854|NCT00599482|"     Most patients with sickle-cell disease have periodic intensely painful episodes. To manage     this pain, we are proposing the drinking of at least 500 mL of water followed by far infrared     radiation.   "
209855|NCT00599495|"     The purpose of this study is to determine whether a reduced intensity conditioning regimen     followed by allogeneic stem cell transplantation from unrelated donors is a feasible and     effective treatment for patients with multiple myeloma who failed a previous autologous stem     cell transplantation.   "
209856|NCT00599508|"     To evaluate the effect of supplemented berry fruit juice and whole fruit berry powder on     memory performance and brain function in older adults   "
209857|NCT00599521|"     The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in     the treatment of Acne Vulgaris.   "
209858|NCT00599534|"     Oral therapy with montelukast may lead to improved polysomnographic findings in children with     mild to moderate OSAS with and without allergic rhinitis who a priori require T&A for OSAS.      - A significant proportion of the children with OSAS treated with montelukast will show     reduced severity of OSAS, and this will obviate the need for surgical T&A.   "
209859|NCT00599547|"     The purpose of this study is to determine whether a reduced intensity conditioning regimen     followed by allogeneic stem cell transplantation is a feasible and effective treatment for     patients with primary myelofibrosis.   "
209860|NCT00599560|"     Summary: Some of sicknesses are well known to be provoked by inadequate adaptation to     physical and/or psychogenic stress in their daily life. Meniere's disease is also a common     inner ear disease accompanied with vertigo, hearing loss and tinnitus especially in civilized     people under stressed life style. Its oto-pathology was firstly revealed in 1938 to be inner     ear endolymphatic hydrops through the temporal bone study. To elucidate the neuroscientific     relationship between stress and inner ear, we examined plasma vasopressin (the     anti-diuretic stress hormone) and its receptor, V2R in the endolymphatic sac (the inner     ear endo-organ for endolymph absorption) in Meniere's patients.   "
209861|NCT00599573|"     The hypotheses of this study are:        1. Ondansetron will show a decrease in cocaine use from baseline in individuals with HIV          who are cocaine using.        2. Ondansetron will show a decrease in cravings from baseline in individuals with HIV who          are cocaine using.      After informed consent and screening, HIV infected individuals who are cocaine dependent and     qualify for the study will be offered ondansetron 4mg BID for six weeks in an open label     format 4mg BID has been found to have efficacy compared to placebo. At screening and then at     each visit, they will be asked to provide urine and a drug of abuse screen will be conducted     to assess for cocaine. They will be asked to detail their recent cocaine use in the last     month and then will be given a visual analog scale to assess their craving for cocaine. They     will be asked to return weekly for 6 weeks to receive a week's supply of ondansetron and to     give a urine sample that will test for cocaine. They will fill out a time line follow back     for the past week and asked to assess their craving for cocaine on a visual analog scale.   "
209862|NCT00599586|"     The purpose of the study is to testify whether acupuncture is effective for migraine, and     provide evidence for the hypothesis thatAcupuncture effect is based on meridians, and     gathering of meridian Qi is the key point.   "
209863|NCT00599599|"     The primary aim of this project is to examine the efficacy of prolonged exposure (PE) therapy     at reducing HIV-related PTSD symptoms, increasing adherence to antiretroviral medication     regimens, and increasing health-related quality of life (QOL) in HIV+ patients.   "
209864|NCT00599612|"     This will be an open label study conducted at one site. Six healthy male subjects will be     enrolled to ensure at least four fully evaluable subjects. Each subject will receive a single     10 milligram (mg) oral dose of GW856553 containing 50 microCi (µCi) of [14C] GW856553. Urine     and fecal samples will be collected until 216 hour after dosing but subjects may be     discharged after 168 hour if 90% of the dose is recovered and/or <1% of the dose is excreted     in a 24 hour period. Blood and plasma will be collected at various sample times after dosing     to measure parent drug and total drug-related material. Samples of urine, faeces and plasma     will be transferred into a separate study to characterize and quantify metabolites in these     matrices. Safety will be assessed by adverse event monitoring, vital signs, electrocardiogram     (ECG) and clinical laboratory tests.   "
209910|NCT00591292|"     Dose escalating study of orally administered indibulin at twice daily schedule in subjects     with solid tumors.   "
209947|NCT00591773|"     The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil,     once daily (QD), co-administered with chlorthalidone in treating individuals with essential     hypertension, compared to treatment with chlorthalidone alone.   "
209865|NCT00599625|"     The primary objective of this study is to provide data regarding clinical and immunologic     activity of oral doses of pravastatin 80mg administered daily for 6 consecutive weeks, for     the treatment of active Crohn's disease as shown by the Harvey-Bradshaw Index (HBI) and/or     elevated C-reactive protein (CRP).      We hypothesize pravastatin will significantly reduce symptoms of Crohn's disease, as shown by     a decrease in HBI, by the end of the study period. Secondary outcomes of this study include     the effect of pravastatin on C-reactive protein, ESR, proinflammatory cytokines, and fecal     lactoferrin.   "
209866|NCT00599638|"     Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain,     however, not all patients will respond to this drug. This study will compare the efficacy of     pregabalin when administered with an experimental drug PF-00489791, in patients with     post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin     alone.   "
209867|NCT00590720|"     The main objective of this study is to evaluate the safety and tolerability of multiple fixed     doses of MEDI-528 in adult patients with stable asthma and exercise-induced     bronchoconstriction (EIB).   "
209868|NCT00590746|"     The purpose of this study is to assess the risk for falls among elderly Emergency Department     (ED) patients.This study will use 2 tests of balance, the Bertec Balance Screening Test and     the Up and Go test. These tests measure how steady a person is while standing, walking, and     turning 180 degrees. After patients have returned home, they will be contacted at 7 days, 30     days and 6 months to determine if they have sustained a fall during these intervals in order     to find out how predictive the balance tests are in determining the risk of future falls.   "
209869|NCT00590759|"     The purpose of this post-approval study is to evaluate the long-term performance of the GORE     TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic     aortic (DTA) aneurysms   "
209870|NCT00590772|"     The hypothesis is that a leukotriene receptor antagonist (LRA), montelukast, will decrease     nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep     fragmentation in individuals with year round allergic rhinitis or perennial allergic rhinitis     (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.   "
209871|NCT00590785|"     To compare disease-free survival (DFS), overall survival (s), and toxicity of high-isk     primary breast cancer patients with negative axillary lymph nodes or with one to three     positive nodes treated with adjuvant high-dose chemotherapy with doxorubicin plus     cyclophosphamide (AC), versus high-dose sequential chemotherapy with doxorubicin followed by     cyclophosphamide (A-->C).   "
209872|NCT00590798|"     To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely     ambulate within 30 minutes of catheterization.   "
209873|NCT00590811|"     The aim of this study is to determine the prevalence of menstrual cycle related pain     complains in adolescents and young adults.   "
209874|NCT00590824|"     Evaluate the antitumor activity of hu14.18-IL2 in the minimal residual disease setting.     Evaluate the time to recurrence and overall survival of patients treated with hu14.18-IL2.   "
209875|NCT00590837|"     A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5     + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in     complete remission (CR) will then receive a post-remission schedule with or without lomustine     according to randomization. Patients from 60 to 65 years old will be proposed to reduced     conditioning allogeneic transplantation after first consolidation.   "
209954|NCT00591864|"     The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI)     relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal     diagnostic mammogram and/or ultrasound study.   "
209876|NCT00590850|"     Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder.     Some surgeons suggest that surgical treatment is the best option, while others suggest that     nonoperative care is the best treatment. There is no evidence to date that either option in     superior. For this reason, we propose to conduct a prospective, randomized clinical trial of     surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This     study will use both objective clinical and patient-based outcome measures. The purpose of     this study is to see if there is a difference between clinical outcomes (healing rate, time     to healing, time to return to work, Constant Score, complications), functional outcomes (DASH     Score), and health related quality of life (SF-36) in nonoperative care and two types of     surgical care for displaced fractures of the clavicular shaft in adults.      Included patients will be randomized into one of three groups: nonoperative care (Group N);     surgical care using plates and screws (Group P); and surgical care using intramedullary pin     put inside of the clavicle to stabilize it (Group I).   "
209877|NCT00590863|"     This study will compare whether a combination of antidepressant medications is better than     one antidepressant medication alone when given as initial treatment for people with chronic     or recurrent major depressive disorder.   "
209878|NCT00590876|"     In patients with Type 1 Diabetes Mellitus, hypoglycemia (low blood sugar) is the     rate-limiting step to achieve glucose level control. As a result, understanding the body's     responses (including the brain's response) to hypoglycemia is essential for the effective     treatment of patients with T1DM. The purpose of this research is to determine whether     pancreatic islet cell allotransplantation to restore normoglycemia (normal blood glucose     levels) in Type 1 Diabetic patients with hypoglycemia unawareness alters brain fuel     utilization and cognitive performance under euglycemic (blood sugar at 100 mg/dl) and     hypoglycemic (blood sugar at 50 mg/dl) conditions. Three groups of subjects will be studied:     (1) T1DM patients with a history of severe hypoglycemia and/or hypoglycemia unawareness who     have been selected for pancreatic islet cell allotransplantation; (2) T1DM patients who also     have a history of severe hypoglycemia and/or hypoglycemia unawareness; (3) nondiabetic     subjects. All subjects will undergo identical testing including: (a) screening; (b)     neuropsychological testing; (c) and functional magnetic resonance imaging (fMRI) during     euglycemic and hypoglycemic conditions.   "
209879|NCT00590889|"     The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces     the incidence of prosthetic valve endocarditis (PVE).   "
209924|NCT00591474|"     Drinking probiotics in a the form of a yogurt drink will restore normal gastrointestinal (GI)     bacteria in patients whose colon are colonized with vancomycin-resistant enterococcus (VRE).   "
209925|NCT00591487|"     RCT of S/E of lidocaine infiltration in tumescent technique.   "
211943|NCT00624650|"     The purpose of this study is to test a treatment that tries to reduce the amount of fluid in     the lungs of subjects with acute lung injury to see if this is helpful.   "
209880|NCT00590902|"     The purpose of this study is:        -  To measure the ability of OSI-774 to effectively treat bronchioloalveolar cell lung          cancer.        -  To see whether the use of OSI-774 provides meaningful symptomatic benefit in patients          with advanced bronchioloalveolar cell lung cancer.      This study is a Phase II study. The first study of OSI-774 was done to evaluate what dose     should be given to patients with cancer has been completed. The purpose of this research     study is to see whether this experimental treatment, called OSI-774, can cause a type of     non-small cell lung cancer to stop growing or shrink. This study is sponsored by a company     called Genentech, and is being done at Memorial Hospital, as well as other cancer centers     around the country interested in developing new drugs for the treatment of this type of     cancer.   "
209881|NCT00590915|"     The purpose of this study is to make Erwinase available to patients with acute lymphoblastic     leukemia (ALL) who have had previous allergic reactions to certain formulations of     L-asparaginase.   "
209882|NCT00590928|"     H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill     patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor     antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is     unknown, whether proton pump inhibitors are more effective in increasing gastric pH than     H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.   "
209883|NCT00590941|"     The purpose of this study is to determine whether people have genes that make them more     likely to respond to chemotherapy and/or have side effects from chemotherapy for diffuse     large cell lymphoma.   "
209884|NCT00590954|"     The purpose of this study is to test the effectiveness of perifosine in preventing further     tumor growth using the established optimal dose of the drug. A second goal is to determine if     perifosine can block the molecules in the tumor that drive it to divide and grow.   "
209885|NCT00590967|"     Recent studies have shown that the chance of survival among women with advanced cervical     cancer is increased when they receive concurrent chemotherapy and radiation to the pelvis.     However, patients who have advanced disease show loco-regional failure as well as a high     incidence of distant metastasis. Positron emission tomography (PET) scanning has high     sensitivity and specificity in the detection of pelvic and para-aortic lymph node metastases.     While the detection of para-aortic metastases by PET significantly impacts prognosis, PET has     been known to show positive lymph node metastasis in the pelvis only while not detecting     micrometastatic disease in the para-aortic lymph nodes (despite the fact that they are     histologically known).      In addition, patients with positive para-aortic lymph nodes on PET, greater amounts (more     than 45 Gy) of radiation must be used to improve the probability of controlling the cancer.     However, doses greater than this have been limited because of the dose and volume limits to     the small bowel. But, Intensity Modulated Radiation Therapy (IMRT) is a new way of     calculating and delivering radiation therapy. Compared to external beam radiation, IMRT has     the improved ability to deliver large doses of radiation to specific targets while minimizing     the exposure to surrounding normal tissue.      With IMRT, however, the effective dose/volume can be increased more safely and lower the     toxicity of surrounding tissue, thus making prophylactic dosing to para-aortic lymph nodes     not detected by PET safer and more effective.   "
210065|NCT00599755|"     This study will use imaging to look at tumor response to combination chemotherapy of     gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small     cell lung cancer (NSCLC).   "
209886|NCT00590980|"     Patients with blockage of the blood vessels that supply blood to the back of the brain, known     as vertebrobasilar disease (VBD), are at risk of having a stroke or temporary symptoms of a     stroke known as transient ischemic attack (TIA). The risk of repeated stroke associated with     VBD may be affected by several risk factors, including the degree to which the blockage     reduces the blood flow to the brain. Patients with VBD have different levels of blockage     ranging from partial blockage to complete blockage, which can affect the blood flow to the     brain by variable amounts. The purpose of this research is to determine if patients with     symptomatic VBD who demonstrate low blood flow to the back of the brain on magnetic resonance     (MR)imaging are at higher risk of developing another stroke or TIA than patients with normal     blood flow.   "
209887|NCT00590993|"     Past studies have shown that MRI is useful for staging prostate cancer. This study will use     magnetic resonance spectroscopic imaging (MRSI) to obtain more information. MRSIs with MRIs     help doctors locate prostate cancer and determine the extent of tumor before deciding on     treatment. This study looks at structural and chemical properties of prostates in prostate     cancer patients before and after treatment.   "
209888|NCT00591006|"     The purpose of this research is to determine if patients who receive phenytoin (also commonly     known as Dilantin) before taking corticosteroids will show less memory impairment and     hypomanic symptoms (feelings of agitation, overexcitement or hyperactivity) than those     receiving placebo (an inactive substance). This research also seeks to determine if patients     taking phenytoin before corticosteroids show more activity in the area of the brain involved     with memory than those receiving placebo.      This research is being done because increased levels of cortisol (the body's natural     corticosteroid) in the body are frequently associated with forgetfulness, and interventions     that may prevent or reverse this effect are of great importance.   "
209889|NCT00591019|"     A study on the effects of the FDA approved drug Modafinil upon attention problems associated     with tinnitus. This is considered to be a safe drug with few side effects. Each subject will     be asked to participate in 3 sessions each lasting approximately 1 hour in which cognitive     testing and recordings will be taken. The study involves each subject taking a 2- week supply     of Modafinil and a 2- week supply of placebo. We hypothesize inattention related to     thalamocortical dysrhythmia found in tinnitus can be reduced by Modafinil thus improving     vigilance.   "
209890|NCT00591032|"     AQUA FONTIS is a unicentric, multidisciplinary, prospective cross-section and longitudinal     study that aims at the development of a more clear-cut diagnostic definition and     classification of non-thyroidal illness syndrome (NTIS).   "
209891|NCT00591045|"     This is a randomized phase II multicenter controlled study of oxaliplatin, calcium folinate,     and 5-fluorouracil (mFOLFOX7) as neoadjuvant chemotherapy for resectable advanced gastric     cancer.      Hypothesis: Neoadjuvant chemotherapy may improve 5 year overall survival compared with the     control.   "
209892|NCT00591058|"     The purpose of this study is to evaluate the safety and biologically active dose of TM-601 in     adult patients with recurrent malignant glioma.   "
225804|NCT00808340|"     The primary purpose of the study is to compare the performance of three soft bifocal contact     lenses in terms of the vision provided by the lenses.   "
209893|NCT00591071|"     During hospitalization in the intensive care unit (ICU), the occurrence of a blood glucose     imbalance is frequent and associated with increased mortality. These observations have     resulted in the hypothesis that intensive insulin therapy designed to control blood glucose     would improve the prognosis of patients admitted into the ICU. In a prospective, randomized,     single center study in a surgical ICU during which the majority of patients had undergone     cardiac surgery, intensive insulin therapy with the objective to maintain glycemia below 110     mg/dl (6.1 mmol/L) provided a significant reduction in ICU mortality and hospital mortality     compared to a group with a glycemic objective of 200 mg/dl.      In a recent published article, the beneficial effect of intensive insulin therapy seems less     obvious in a randomized single center study in a medical ICU. One of the potential factors     limiting the impact of a therapeutic strategy like this one is the absence of achieving     strict glycemic control for all patients on intensive insulin therapy. Additionally, the     implementation of such a therapeutic strategy results in an increased risk of hypoglycemia,     the consequences of which on morbidity remain unclear.      The aim of our study is to determine, in a mixed population of medical and surgical patients     admitted to the ICU, requiring artificial ventilation with a expected duration above 48     hours, the impact of effective strict glycemic control (<6,1 mmol/l) compared to a     conventional glycemic control (<11mmol/l) on hospital mortality.   "
209894|NCT00591084|"     The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute     ischemic stroke.   "
209895|NCT00591097|"     The reported normal values used in diagnosing and treating pediatric kidney stone formers are     based on adult values or historic data from small studies. Urinary supersaturation indices     which are now described in the adult stone literature as more sensitive predictors of stone     composition, and precise predictors of response to therapy, are not established in children.     The goals of this prospective study are to redefine normal values for pediatric urinary     metabolites and supersaturation indices based on samples from a large number of healthy     children and to identify if a difference in urinary supersaturations in children is     protective.   "
209896|NCT00591110|"     The study design is a randomized intervention evaluation. Ten senior centers in predominately     African American communities in the Birmingham, Alabama will be selected as sites for the     educational intervention. Five centers will be randomly assigned to receive an educational     intervention communicating practical information about vision, eye conditions and eye care as     pertinent to the older African American population. The other five centers will serve as     social-contact controls, where participants will receive an engaging information session on a     non-health related topic. The primary outcome of interest is the change in percentage of     persons receiving comprehensive eye care from pre- to post- intervention. The secondary     outcomes are the process outcomes of improvement in knowledge, attitudes, and values about     vision, eye conditions, and eye care.   "
209963|NCT00591981|"     Our goal is to develop a reliable, physician and patient-friendly, pre-operative Thoracic     Onco-Geriatric Assessment (TOGA) to predict surgical risk in geriatric oncology patients with     thoracic neoplasms of the lung, esophagus, pleura and thymus, modeled upon existing CGA     tools, including the Preoperative Assessment of Cancer in the Elderly (PACE)   "
209897|NCT00591123|"     In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen     known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study     is to test the safety and effectiveness of this combination of chemotherapy drugs and to see     how they affect your cancer.      Another purpose of this study is to examine samples from your blood and tumor. This research     will be done to better understand how subjects respond to treatment. Specifically,     researchers will look at the way your genes and proteins respond to drugs like those used in     this study.   "
209898|NCT00591136|"     Dose-finding and pharmacokinetic trial of orally administered Indibulin to patients with     solid tumors.   "
209899|NCT00591149|"     A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients     to determine their effect on the control and reduction of tumor size   "
209900|NCT00591162|"     Bone metabolism is adversely affected by severe burns in children for a period of time.   "
209901|NCT00591175|"     The goal of this study is to see if giving patients information about how smoking affects     oral health will help them quit smoking. What we learn from this study will help researchers     find new ways to help smokers.   "
209902|NCT00591188|"     The aim of this study is to determine preliminary efficacy of capecitabine and     interferon-alpha in second-line after interleukin-2 based regimens in patients with MRCC   "
209903|NCT00591201|"     Tumor necrosis factor (TNF) alpha is a pro-inflammatory cytokine playing a significant role     in the pathogenesis of the spondyloarthropathies (SpA). Infliximab is a TNF alpha blocking     monoclonal antibody efficacious and safe as treatment of adult-onset SpA.      In this study we will try to demonstrate that infliximab administered at 5mg/kg to patients     with juvenile onset SpA over a period of 12 weeks will have more efficacy than placebo and     that it will be well tolerated. At the end of this phase, patients will go into a 52-week     open extension to demonstrate sustained efficacy, safety, and tolerability of infliximab We     will include 34 patients with juvenile onset SpA unresponsive to standard treatment. Efficacy     will be assessed by counting the number of actively inflamed joints and a number of other     parameters.   "
209904|NCT00591214|"     The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C     virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with     chronic hepatitis C.   "
209905|NCT00591227|"     This study will examine two questions: 1. Whether insulin treatment of high blood sugar in     patients with diabetes while they are in the emergency room will improve how quickly they     recover from illness if they need to be hospitalized. 2. Whether immediately beginning long     lasting insulin detemir in patients with diabetes when they are admitted to hospital from the     emergency room will improve how quickly they recover from the illness which necessitated     hospitalization.   "
209906|NCT00591240|"     The purpose of this proposal is clinical validation of an electrochemical biochip for rapid     pathogen identification and antibiotic susceptibility determination.   "
209907|NCT00591253|"     The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil     compared to placebo, once daily (QD), in African-American participants with essential     hypertension.   "
209908|NCT00591266|"     The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil,     once daily (QD), co-administered with amlodipine in treating individuals with essential     hypertension, compared to treatment with amlodipine alone.   "
209909|NCT00591279|"     This study evaluates strategies for the surveillance of post-polypectomy patients for the     control of bladder cancer   "
209911|NCT00591305|"     This study will determine efficacy of a new and combined treatment of laryngeal recurrent     respiratory papillomatosis (RRP), by using a 585 nm pulsed dye laser (PDL) and a dietary     supplement, diindolylmethane (DIM). We will compare this new treatment with PDL-only, in a     total of 30 children (15 of each treatment), to determine whether this combined treatment     would be effective and safe in preventing the RRP recurrence. This is the first study to     combine PDL technique with DIM, to develop a new, voice-preserving and long-term effective     method of managing laryngeal RRP in children.   "
209912|NCT00591318|"     Many patients with schizophrenia and schizoaffective disorder have symptoms that persist,     including hallucinations or delusions, despite adequate pharmacotherapy with antipsychotic     drug. Glutamate is a major excitatory neurotransmitter in the brain that has been implicated     in several brain diseases. NMDA antagonist drugs cause symptoms of psychosis in otherwise     normal persons. It is postulated that reduced NMDA receptor mediated neurotransmission leads     to an increase in synaptic glutamate. Excessive synaptic concentrations of glutamate can     produce excitatory neurotoxicity. Agents which reduce excess glutamate activity are     neuroprotective. This therapeutic strategy has been applied to schizophrenia through the use     of compounds that reduce presynaptic release of glutamate or otherwise decrease excessive     postsynaptic stimulation, including lamotrigine, memantine and a m-GLU-R2 agonist (LY354740)     with the hypothesized result of a reduction in psychotic symptoms.      Recently it was shown that a commonly available antibiotic (ceftriaxone) has the unique     neuroprotective function of decreasing the amount of extracellular glutamate in nervous     system tissue by increasing the number of glutamate transporter proteins. Our clinical     experience with patients who have refractory psychosis and past Lyme disease indicates that     in some patients psychosis may improve with IV ceftriaxone therapy. Whether this improvement     was due to its antimicrobial or glutamate effect or a placebo effect is uncertain. In a     placebo-controlled design, this study investigates the ability of ceftriaxone to decrease     psychotic symptoms in patients with refractory psychotic disorders. In addition, the study     will examine glutamatergic functional activity before and after treatment using brain imaging     with magnetic resonance spectroscopy.   "
209913|NCT00591331|"     This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in     humans, after exposure to UV radiation.   "
209914|NCT00591344|"     The goal of this trial is to compare the effect of two different exercise programs on     neuro-physiological, motor, functional, and quality-of-life issues in individuals with     Parkinson's disease to determine which program is most beneficial.   "
209915|NCT00591357|"     To determine whether symptomatic treatment of the diarrhea in CDAD reduces morbidity and     mortality of this serious nosocomial infection in patients who have antibiotic-associated     diarrhea. Both C. diff positive and negative patients will be included.   "
209916|NCT00591370|"     Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to     DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by     mouth, it can be given daily over a long period of time. We think that temozolomidemay work     best if it is given every day for 6 weeks at a time. Temozolomide given by this extended     schedule is experimental, although we have found that it is safe and can shrink melanoma in     some patients.      One big advantage of TMZ is that it is given by mouth instead of by vein. This means that it     can be given daily over a long period of time rather than off and on like DTIC. We think that     TMZ may work better if it is given every day for 6 weeks. TMZ given by this extended schedule     is experimental although we have found that TMZ given in this way is safe and can shrink     melanoma in some patients. When extended dosing TMZ was given with either thalidomide or     long-acting interferon-α, about 30% of patients had their tumors shrink. We think that this     shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in     melanoma by themselves.      In this study, we will treat patients with TMZ alone using this extended dosing schedule to     see how many patients experience tumor shrinkage.      We also want to learn more about which tumors are more likely to shrink from TMZ treatment.     We will test samples of your tumor for whether or not a gene called MGMT has been turned on,   "
209917|NCT00591383|"     Single arm, open label, Phase I, dose-escalation study of indibulin in combination with     erlotinib in subjects with advanced histologically confirmed, solid tumors for which no     standard therapy exists and for whom treatment with erlotinib is considered medically     acceptable.   "
209918|NCT00591396|"     A Phase I Trial of ZIO-101 (Darinaparsin) in Solid Tumors   "
209919|NCT00591409|"     The objective of the trial was to establish the dose-response of T2 in Japanese and Caucasian     Subjects. Part A: Japanese Subjects   "
209920|NCT00591422|"     The study of Dariniparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas   "
209921|NCT00591435|"     Anaesthesia and surgery related time intervals of three standard operations are compared     depending on whether residents or consultants are performing anaesthesia and surgery.      Hypothesis: Perioperative workflow is influenced by state of education, time intervals     reflecting anaesthesia as well as surgical performance increase due to resident training.     Therefore, costs of perioperative care increase as well.   "
209922|NCT00591448|"     The purpose of this study is to evaluate the use of Virtual Reality (VR) technology during     Physical Therapy (PT) and/or Occupational Therapy (OT) for patients with burns. Research     questions: Do patients have increased joint Range of Motion (ROM) and reduced pain when using     VR during PT compared to PT/OT when VR is not used? Do scores on an imaging ability scale     correlate with the effects of VR when used with PT/OT? Do adults and children differ in their     ability to engage in the virtual world?   "
209923|NCT00591461|"     Barrett's esophagus (BE) is a condition that often occurs in patients who have had GERD for a     long time. The researchers are interested in BE because it can sometimes become a cancer in     the esophagus. The way that we currently diagnose BE is by performing an upper endoscopy and     looking for a change in the color of the esophagus. This color change may represent BE. If     the doctor sees this, he/she may take biopsies of this area.      Studies have shown that making the diagnosis of BE can be hard to make. One of the reasons     why this may be is because doctors may interpret what they see differently during the     procedure. In other words, they may see an esophagus that appears normal in color or abnormal     in color.      The purpose of this study is to compare two doctors' impressions of the appearance of the     esophagus during a single endoscopy procedure.   "
209926|NCT00591500|"     The goal of this study is to find out if some people are more likely to get melanoma, a form     of skin cancer, than others are. To do this we will compare people who have had more than one     melanoma to people who have had only one melanoma and to people who are similar but who have     not developed melanoma.      People respond to the environment in different ways. Some may be born with genes that make     them more likely to get this type of skin cancer. Each person has many ways to repair normal     damage to their genes. Specific genes may affect the repair of sun damage. Other genes affect     the way the skin itself reacts to the sun. We want to find out which genes have normal     changes in them and lead to different responses to exposures, such as the sun. We also want     to find out if sun habits are related to the way these genes work.   "
209927|NCT00591513|"     This clinical trial tests the hypothesis that engineered human skin can reduce the     requirements for harvesting of conventional skin autografts by providing more skin for     grafting from the donor skin used to treat the wounds. In life-threatening burns (e.g.,     greater than 50% of the total body surface area), greater availability of skin may be     definitive to patient survival, and may reduce scar formation at the donor site, and from use     of widely-meshed skin autograft.   "
209928|NCT00591526|"     The first purpose of this randomized trial will be to compare the best treatment group of APL     93 trial (ATRA with early introduction of anthracycline-AraC chemotherapy, followed by 2     consolidation anthracycline-AraC courses and maintenance combining continuous chemotherapy     and intermittent ATRA) to the same regimen, but without AraC. It is hoped that the     investigational arm, with anthracycline alone chemotherapy (without AraC), will have reduced     toxicity without increasing the incidence of relapse, by comparison with a classical     induction/consolidation anthracycline-AraC regimen      Thus :      the main end point for this first randomization is relapse at 2 years secondary end points     are : complete remission rate ; survival and event free survival at 2 years, and     quality-adjusted survival (Q-TWiST).      2) Because patients with initial WBC counts > 10000/mm3 (ie very high counts for APL) appear     to remain at relatively high risk of relapse even with the current reference treatment, they     will not be included in this trial that assesses the reduction of chemotherapy. On the     contrary: i) they will all receive the standard chemotherapy (best treatment group of APL 93     trial);      Thus :      the main end point for this second randomization is relapse at 2 years secondary end points     are : survival and event free survival at 2 years 3)Elderly patients with initial WBC ≤     10000/m3 will receive consolidation chemotherapy without AraC during the first chemotherapy     course, and reduced doses of AraC during the second and third course, followed by G-CSF.   "
210015|NCT00592657|"     Retrospective chart review to determine the presence of rhabdomyolysis among patients     admitted to CHMCA from 1997-2007 with Jimsonweed ingestions and to define possible risk     factors predisposing patients to the developement of Jimsonweed-associated rhabdomyolysis.   "
209929|NCT00591539|"     The goal of this clinical research study is to find out if long-term survivors of childhood     head or neck cancer, who received radiation therapy as part of the overall treatment plan,     are at increased risk of thickening or blockage of the carotid arteries (the major blood     vessels in the neck).      Researchers also want to find out if other medical conditions, such as high blood sugar, high     blood cholesterol, or history of tobacco use may contribute to the thickening or blockage of     the carotid arteries.   "
209930|NCT00591552|"     In an effort to elucidate whether the Harmonic Scalpel will improve sealing lymphatics and     decrease lymphatic drainage thereby decreasing the length of time that chest tubes are     required and minimizing length of stay; the Harmonic Scalpel will be compared to a control     group which uses electrocautery. This study will assess these two different methods to     determine if there is a notable decrease in the amount of drainage with one versus the other.   "
209931|NCT00591565|"     This study is designed to evaluate anxious patients who are only partially responsive to     typical SSRI or SNRI anti-anxiety medication therapy. Patients who are less than 50%     anxiety-alleviated on their SSRI medication will be asked to join the study and be placed on     Acamprosate as well. This type of add-on therapy is common in outpatient psychiatric care.     This is a rater-blinded, patient open-label, non-placebo prospective study, where all     subjects will receive Acamprosate for 8 weeks. This study would be the first to date in this     treatment-resistant patient population, as the investigators will utilize the a comprehensive     set of rating scales in order to best categorize patient responses in regards to anxiety,     co-occurring depression, sleep disorders, alcohol use, and social functioning with this drug.     This study may be pivotal to the initiation of future double-blind, placebo-controlled     studies for this agent   "
209932|NCT00591578|"     The purpose of this study is to compare the efficacy and safety of TAK-491 (azilsartan     medoxomil), once daily (QD), to valsartan in participants with essential hypertension.   "
209933|NCT00591591|"     The goal of this trial is to assess the performance of the OxiplexTS—an absolute     near-infrared oximeter—as an instrument to measure brain oxygenation and hemodynamics in     sleep medicine as well as in the broader field of cardiovascular/cerebrovascular diagnostics.   "
209934|NCT00591604|"     High dose Vitamin D (50,000IU) therapy may increase bone mineral density/bone mineral content     after large burns.   "
209935|NCT00591617|"     Building on a platform of pharmacological treatment with Suboxone (buprenorphine and     naloxone), participants are randomly assigned to one of four psychosocial treatment     conditions.   "
209936|NCT00591630|"     The goal of this clinical research study is to learn if the addition of 90Y Zevalin to BEAM     chemotherapy (carmustine, etoposide, cytarabine, and melphalan) and rituximab is more     effective than the combination of BEAM and rituximab alone in patients with lymphoma who     receive a stem cell transplant.   "
209937|NCT00591643|"     The purpose of this study is to find out if your adrenal glands are normal or abnormal. This     can be determined by whether or not your adrenal gland concentrates more of a labeled     building block of adrenal hormone, norcholesterol. This labeled material had been used as an     investigative diagnostic tool for imaging adrenal glands for many years with success in our     hands. This is a diagnostic procedure. CT, MRI and Ultrasound can determine the size and     presence or absence of tumor but cannot assess the function of the adrenal glands. To     determine hormone concentrations from blood samples would involve more invasive     catherization.   "
209938|NCT00591656|"     The purpose of this study is to determine the therapeutic efficacy and complications of     systemic consolidation therapy with paclitaxel plus carboplatin following primary     chemoradiation for locally advanced cervical cancer.   "
209948|NCT00591786|"     The objective of the trial was to establish the dose-response relation of Org 25969     (sugammadex) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during     sevoflurane anesthesia for Japanese subjects.   "
209939|NCT00591669|"     Inflammatory bowel disease (IBD) is a common chronic inflammatory disorder, but a noninvasive     method of assessing disease location, severity, and extent is currently not available.     Recently published animal data suggests that using transabdominal ultrasound enhanced with     encapsulated gaseous microbubbles may provide a reliable, noninvasive means to detect and     quantify areas of intestinal inflammation. This study will evaluate the role of     Contrast-enhanced ultrasonography (CEU) for use as a diagnostic tool in patients with IBD. We     hypothesize that the severity and extent of chronic intestinal inflammation, as quantified by     CEU-derived video intensity scores, will correlate with endoscopically-derived measures of     intestinal inflammation as obtained from the Crohn's Disease Endoscopic Inflammatory Index     (CDEIS). A total of 40 patients will be enrolled in the study, 30 patients with IBD and 10     patients undergoing colonoscopy for other reasons. Prior to colonoscopy CEU assessment of     small and large intestine will be performed to evaluate neoangiogenesis and intestinal blood     flow. The correlation between the CEU-derived video intensity score and CDEIS will be     assessed using Pearson's correlation coefficient. Subjects may also undergo scoring using the     Rutgeerts Score, an endoscopic disease assessment index used to score disease activity in     patients with previous ileocolonic resection. Comparing video intensity between IBD and     non-IBD subjects will be performed using the Wilcoxon rank sum test, with a secondary aim of     establishing preliminary estimates of the sensitivity of the microbubble scoring system.   "
209940|NCT00591682|"     Primary Objectives:        1. To determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and          schedule of MSX-122        2. To characterize the dose limiting toxicities (DLTs) and determine the overall safety and          tolerability of MSX-122      Secondary Objectives:        1. To determine the pharmacokinetics and pharmacodynamics of orally administered MSX-122        2. To evaluate the preliminary evidence for anti-tumor activity of MSX-122        3. To perform correlative studies to elucidate signaling pathways involved in CXCR4          activation in blood and optional tissue specimens by IHC (immunohistochemistry) and RPPA          (reverse phase protein microarrays)   "
209941|NCT00591695|"     The purpose of this study is to verify whether stent positioning for malignant obstruction of     the colon and rectum followed by elective surgery allows reduction of postoperative     complications and hospital stay without worsening of evolution of the neoplastic illness,     compared to emergency surgery.      Primary endpoint will be 60 days postoperative morbidity. Others endpoints will be     postoperative mortality, length of hospital stay, need for analgesia.   "
209942|NCT00591708|"     Maximizing calcium retention by the skeleton within the genetic potential is a key strategy     to prevent osteoporosis. It has been shown that calcium retention varies between blacks and     whites and between gender within race. This study is designed to study the relationship     between calcium intakes and calcium retention in Asian adolescent girls and boys. It is     hypothesized that calcium intakes which maximize calcium retention will be lower in Asians     than for whites studies under the same conditions. In addition it is thought that the     differences between races in the physiological mechanisms involved in calcium metabolism will     result in a lower calcium intake required to observe a plateau in calcium retention. This is     turn could be translated into lower calcium requirements in Asians relative to Caucasians for     achieving optimal peak bone mass.   "
209943|NCT00591721|"     Approximately 60% of individuals with multiple sclerosis (MS) describe fatigue as their most     disabling symptom. Energy conservation education involves teaching people with MS different     strategies to manage fatigue and reduce its impact on daily life. Despite growing evidence of     the effectiveness of face-to-face energy conservation education, not all people with MS are     able to access these programs. The purpose of this project is to test the effectiveness and     efficacy of a teleconference-delivered energy conservation education program for people with     MS. The primary goals of the project are to reduce the impact of fatigue on participants'     everyday lives, reduce fatigue severity, and improve quality of life. Secondary goals are to     increase self-efficacy for managing fatigue and increase the number of energy conservation     strategies used. The study will employ a randomly allocated two group time series design with     a wait-list control group, which is one type of randomized control trial. A total of 181     people with MS will be recruited through direct mailing and advertising. The program will be     delivered by telephone teleconference by a licensed occupational therapist. Outcome measures     will be administered over the telephone by a research assistant before and after the program,     at three months and at six months. We hypothesize that: (1) individuals in the immediate     intervention group achieve better outcomes than individuals in the wait-list control group;     (2) the program leads to significant reductions in fatigue impact and fatigue severity, and     improved quality of life; and (3) improvements in the outcomes can be maintained over six     months.   "
209944|NCT00591734|"     This is a non-randomized, open label Phase II study comparing bevacizumab and everolimus in     the treatment of metastatic melanoma.   "
209945|NCT00591747|"     Women aged 50 and older are disproportionately affected by breast cancer, not only in terms     of new diagnoses, but also in terms of survivorship. Approximately 85% of women who receive a     first diagnosis of breast cancer are aged 50 and over, thus older women constitute the     largest group of breast cancer survivors. Yet, few studies have focused on evaluating whether     physical activity and exercise interventions affect long-term symptoms, physical fitness and     function, and body composition of older breast cancer survivors. Due to the combined effects     of breast cancer, related treatments and aging it is likely that exercise is even more     beneficial for older breast cancer survivors than for younger survivors. Along with the     cancer-related symptom of fatigue common to cancer survivors, older survivors face     age-related declines in bone and muscle mass, muscle strength, bone health and physical     function (gait and balance) that are likely exacerbated by reduced physical activity in     survivorship and side effects of adjuvant cancer treatment. All women, regardless of age, are     at risk for breast cancer recurrence. Recent epidemiologic evidence suggests a link between     exercise and reduced risk of cancer recurrence in breast cancer survivors. Strength training     is specifically suited to reverse or slow age-related declines in bone, muscle, strength and     function and has shown promise to reduce cancer-related fatigue. However, no controlled     trials of strength training in older breast cancer survivors have been conducted.   "
209946|NCT00591760|"     The aim of this study is to investigate the potential benefits of the correction of growth     hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure     due to left ventricular systolic dysfunction.   "
209950|NCT00591812|"     Patients in this study require a replacement of a lower thighbone and knee joint. A new     device, called the ComPreSs, will be used in this study to replace the lower thighbone. This     new device has not yet been approved by the Food and Drug Administration (FDA). There is not     enough data to assure that it is as good as other devices currently available. Taking part in     this study will help provide data to the FDA. Other devices used to replace large pieces of     bone and joints in the leg can result in damage to the bone over time. The bone damage can     cause the device to come loose from the bone. This is a bad problem, and causes pain, and     often more surgery is needed. This new device connects to the bone in a different way to     prevent some of the problems seen with other devices. The new device protects the bone, and     may help the replacement last longer. So far, the device has been used in over 50 patients on     a selective basis.   "
209951|NCT00591825|"     The research team hopes to use brain imaging and mental testing to learn more about specific     phobias and the treatment of phobia. When given directly prior to therapy sessions,     D-cycloserine has been shown to enhance the effects of therapy. This study hopes to identify     reasons why D-cycloserine has this effect by measuring brain activity.   "
209952|NCT00591838|"     The purpose of this study is to use SBRT in patients with early stage lung cancer and find     out what effects (good and bad) SBRT has on their cancer. This research is being done because     SBRT has not been used very often in patients with early stage lung cancer or in patients     with other serious health problems. In addition, this study also will gather information     about patient's health and hospitalization history. This information will be used to find out     if there are any factors that can help predict recovery or outcome of patients with lung     cancer.   "
209953|NCT00591851|"     HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a     protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard     treatments for this type of cancer will help some people, but there is a moderate to high     chance that your cancer may come back.      The purpose of this study is to see if a new regimen will be effective in preventing cancer     from coming back. This is a phase II trial. In this trial, patient get a drug regimen that     has been tested in small groups of people to see what dose is safe. Researchers now wish to     see how effective the drug is for HER-2/neu (+) breast cancer. The objective includes looking     at short-term side effects and risks of the drug. All of the drugs on this regimen can affect     the heart which can be a serious side effect. The drugs affect on heart function is a primary     focus.   "
209955|NCT00591877|"     Patients with refractory GERD on BID PPI's assigned to the acupuncture group will have     significant improvement in their symptoms after receiving acupuncture for 6 weeks as compared     to sham acupuncture given for the same duration.      Primary Aim 1:To determine the efficacy of acupuncture in the treatment of refractory GERD.      Participants with refractory GERD on BID PPIs randomized to yoga will have a significant     relief in the symptoms of reflux.      Primary Aim 2:To determine the efficacy of yoga in the treatment of refractory GERD.   "
209956|NCT00591890|"     Single arm, open label, Phase IB study of indibulin capsules in subjects with advanced solid     tumors; eligible subjects will have a baseline PET scan showing a standardized uptake value     (SUV) of ≥5.0 in ≥1 lesion on an 18F-FDG (fluorine-18-labeled deoxyglucose) scale.   "
209957|NCT00591903|"     The concept of diabetic cardiomyopathy was initially defined more than 30 years ago, as     cardiac failure in diabetic subjects in the absence of underlying coronary artery disease.     Diabetes is also thought to contribute to earlier stage cardiac systolic dysfunction and/or     to isolated diastolic dysfunction, in excess of underlying coronary artery disease and     hypertension. More globally, it is recognized that subjects with type 2 diabetes have more     extensive cardiovascular disease and a worse outcome for a similar level of disease than     non-diabetic subjects. Despite this epidemiological evidence, the biological programming     underpinning the myriad presentations of the diabetic heart' are poorly characterized in     humans.      Proteomics has emerged as an unbiased technology that enables the measurement of large     numbers of steady-state protein levels. The potential to identify a diabetes associated     proteomic signature in the heart would be a novel approach to identify putative biological     programs altered by the diabetic state.      A portion of the right atrial appendage is removed to insert the cardiac bypass machine     cannula in certain cardiothoracic procedures. This tissue is usually discarded, however, we     propose that it could be employed to examine whether otherwise similar subjects with and     without diabetes have distinct atrial proteomic signatures. This pilot study may provide     insight into potential biological pathways that orchestrate the worse cardiac prognosis in     type 2 diabetic versus non diabetic control subjects.   "
209958|NCT00591916|"     Primary research questions/Purpose of the Research.        1. Determine the short term (epidermal regeneration, reduction of pain, infections and          length of stay) and long term (scarring, long term recovery, and cost of treatment)          outcomes of Microbial Nanocellulose (NC) and fine mesh gauze impregnated with hyaluronan          and thrombin (HT).        2. Determine if donor site treatment with NC and HT is as safe as the use of Scarlet Red          ointment dressing.           b. Describe the importance of the knowledge that you expect to gain from the research.           To find a donor site dressing that has outcomes equal or better than that of scarlet          red.   "
209959|NCT00591929|"     Decreased range of motion is common after fractures around the knee and can impact a     patient's ability to perform activities of daily living such as rising from a seated position     or getting in and out of a bathtub. A continuous passive motion (CPM) machine is a machine     that continuously moves a joint (such as the knee) without the patient having to use the     muscles in his/her leg. A goal of this therapy is to maintain as much motion as possible     following this injury. This study is a randomized, prospective study to evaluate the     effectiveness of CPM in maintaining knee range of motion following open reduction and     internal fixation (ORIF) of fractures around the knee   "
209995|NCT00592397|"     The purpose of this pilot study is to optimize conditions for a planned human intervention     study focusing on how diet predispose for, and influence, lifestyle disease development and     its consequence in cardiovascular disease development.   "
209960|NCT00591942|"     The restoration of indirect partial and full coverage restorations in dentistry necessitates     the use of a luting agent to act as a means of mechanical and potentially, chemical retention     of the restoration. Upon the introduction of the first generation of glass Ionomer cements     for use as a luting agent, an elevated short-term post operative hypersentivity was reported.     In part, this adverse event was considered to be due to a desiccating effect of the cement as     water is utilized in the setting reaction and thus a desiccation of the dentinal tubules was     proposed as a potential mechanism leading to disruption of the neurosensory odontoblasts.     Further materials development in the field of dental cement luting agents has lead to the     introduction to the current market of resin formulations that have an alternative mechanism     of setting. Consequently, there are anecdotal reports of a decrease in the incidence of     post-operative sensitivity but no comparison with the effect of conventionally used dentin     desensitizing agents as a part of the bonding process of the restoration.      The purpose of this trial is a single blinded parallel design randomized clinical trial to     evaluate the perceived incidence of post-operative sensitivity when full coverage all ceramic     crowns or short-span three unit fixed partial dentures (dental bridge) is fabricated in the     posterior part of the mouth. The dental crowns or bridges will be bonded with conventional     glass ionomer cement or a Urethane dimethacrylate / Bis-GMA composite resin dental cement.     Outcome measures will be both objective clinical criteria and the use of a calibrated pain     survey instrument.   "
209961|NCT00591955|"     The purpose of this study is to determine factors which predict a complicated hospital course     and then to develop from these findings an Emergency Department guideline to assist in     knowing who is at highest risk of elderly patients with infection presenting for care.   "
209962|NCT00591968|"     The role of teleradiology has far reaching implications for the health of remote and     underserved populations. The ability to coordinate radiographic evaluation and diagnosis from     a distance has the potential to raise the standard of patient care throughout the world.     Perhaps the safest and most cost effective mode of teleradiology today is telesonography. The     current project attempts to determine the extent that telesonography improves the standard of     care within a rural government-run primary clinic within the Dominican Republic. The work     reported herein is intended to compare the use of telesonography to the current standard of     sonographic examination (referral to government hospital 60km from target clinic). The study     was conducted by randomly assigning 100 patients with clinical indications for sonographic     examination into experimental and control groups. Following a 60-day implementation period,     the following research questions will be addressed: 1) To what extent does the use of     asynchronous telesonography increase the percentage of definitive diagnoses based on the     total number of scans (definitive diagnoses / total number of scans)? 2) To what extent does     the use of asynchronous telesonography increase the continuity of care for patients? 3) To     what extent does the elapsed time between scanning and final radiological interpretation     decrease with the use of asynchronous telesonography? This study will also look at the     history of telemedicine / telesonography and its dissemination into the mainstream practice     of medicine, explore training protocols that may be used to assist others to establish new     telesonography programs in a developing nations, and discuss both advances and persistent     barriers to the implementation of telesonography programs.      Hypothesis:      The use of a store-and-forward telesonography system in this setting will increase the speed     and number of final diagnoses per scan received by the target clinic and will increase the     continuity of care by increasing the number and speed of follow-up appointments to the target     clinic.   "
209964|NCT00591994|"     Tinnitus is defined as the perception of sound in the absence of a external source. About 15     % of the population is believed to experience tinnitus and for about 20 % of them it may     become a very serious problem. Total comprehension of tinnitus pathophysiology has not yet     been achieved, but modern theories focus in brain hyperactivity following inner ear damage,     with involvement of various neurotransmitters. Piribedil,a dopamin agonist, has been used to     treat tinnitus, focusing in dopamine release, which is inhibitory. Electrophysiological     methods,like acoustic otoemissions and electrocochleography may reveal the changes in     peripherical and central auditory pathways and help to choose the specific patients who could     benefit from piribedil treatment.   "
209965|NCT00592007|"     The main purpose of this research study is to see if adding fulvestrant (Faslodex) to     erlotinib (Tarceva) is effective in patients with stage IIIb/IV Non-Small Cell Lung Cancer.   "
209966|NCT00592020|"     Today the minimal invasive access is used for a lot of different operations. This technique     takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical     complication rate (e.g. hernia, wound infection).      Especially patients under immunosuppressive therapy could benefit from this technique. First     results in minimally invasive kidney transplantation indicate that it may be performed     quickly and safely. Benefits are expectable on postoperative pain, recovery, and surgical     complications. Another retrospective study showed lower rates of hernia, abdominal wall     relaxations, and a better postoperative cosmetic.      The aim of this study is to compare the classic hockey stick incision with a minimal invasive     incision in a randomized clinical trial.   "
209967|NCT00592033|"     In COPD patients with desaturation during exercise, several studies have shown an acute     beneficial effect of supplemental oxygen. Therefore, both the British Thoracic Society and     the American Thoracic Society guidelines recommend supplemental oxygen to patients who     desaturate >4% and to below 88-90%. However, long-term studies have not been able to support     this intervention. In this study of COPD patients, who desaturate and participate in a 7-week     pulmonary rehabilitation programme, we examine the effect of supplemental oxygen on exercise     tolerance, health status, and exacerbation rates. In a randomised design patients trained     either with room air or with 2 litres oxygen per minute from a portable oxygen concentrator.     All patients were asked to exercise every day for 30 minutes.   "
209981|NCT00592215|"     A superior second trimester medical abortion regimen has not been identified. Studies suggest     that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest     median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of     adverse events. Narrowing the interval between the two medications without clinically     reducing effectiveness may increase access and acceptability for patients and reduce costs.     Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between     mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no     studies on shorter intervals with same day administration between mifepristone and     misoprostol in second trimester abortions.      The primary objective is to assess the efficacy of the combined mifepristone/misoprostol     regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8     hours between the two medications.   "
209968|NCT00592046|"     This study uses a new investigational (not yet approved by the FDA for widespread use) drug     called ZIO-101, an organic arsenical. You must be diagnosed to have relapsed/refractory     leukemia or lymphoma (blood cancer) and have tried other standard therapies.      This study is designed to determine whether ZIO-101 may be given safely. The study will also     test whether ZIO-101 helps to treat blood cancer.      We anticipate that approximately 22 to 35 patients will take part in this study.      Arsenic has been used as a medicinal agent for centuries in many different cultures. Most     recently in the United States, an inorganic arsenic compound was approved by the FDA for the     treatment of patients with relapsed acute promyelocytic leukemia (APL). However, use of     inorganic arsenic is limited by a narrow range of activity and systemic toxicity, most     notably of the cardiac system.      ZIO-101 is an organic arsenic derivative. In vitro testing in both the National Cancer     Institute (NCI) cancer cell panel and in vivo testing in a leukemia animal model demonstrated     substantial activity of SGLU against hematologic cancers. In vitro testing of SGLU using the     NCI human cancer cell panel also detected activity against lung, colon and brain cancers,     melanoma, and ovary and kidney cancers. Moderate activity was seen against breast and     prostate cancers cells. Data suggest that organic arsenic generates reactive oxygen species     in the cells to induce apoptosis and cell cycle arrest.   "
209969|NCT00592059|"     The purpose of this study is to determine the therapeutic efficacy and complications of     systemic consolidation therapy with paclitaxel plus carboplatin following radical     hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.   "
209970|NCT00592072|"     At present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood     sugar) and its effects on long-term brain function. The aim of this study is to determine     whether the human brain is able to use medium chain fatty acids (MCFA) and/or their     metabolites as an alternative fuel source during acute hypoglycemia in patients with Type 1     Diabetes Mellitus (T1DM). The hypothesis is that medium chain fatty acids will provide a     rapidly absorbed, non-carbohydrate fuel that will improve cognitive performance during     episodes of hypoglycemia (low blood sugar.)   "
209971|NCT00592085|"     The specific aims are to:        -  Develop a Motivational Relapse Prevention Plus Alcohol Risk Reduction (MRP+) approach          to simultaneously treating both smoking and at-risk alcohol use among smokers          attempting to quit smoking.        -  Estimate the effect size for MRP+ relative to Motivational Relapse Prevention without a          focus on alcohol (MRP) with respect to alcohol at-risk behaviors. The estimated effect          size will be utilized to help guide sample size estimates for a potential clinical          trial.   "
209972|NCT00592098|"     The objective of this study is to investigate the analgesic effect of topical strontium     chloride in stump pain, and to prospectively determine other efficacy and safety measures of     topical strontium chloride in stump pain.   "
209973|NCT00592111|"     Study Hypothesis: Clinical staging without laparotomy/splenectomy is adequate for children     and young adults with Hodgkin's disease who receive chemotherapy as a component of treatment.   "
210063|NCT00599729|"     The purpose of the study is to evaluate the gait spatio-temporal parameters of patients with     degenerative changes in the knee joint and to relate them with 2 questionares (WOMAC and     SF-36).   "
209974|NCT00592124|"     A new approach to HIV prevention currently being studied includes the use of microbicides,     substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved,     anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is     to determine the adherence and acceptability to and blood levels of three daily regimens of     tenofovir in both oral and gel form.   "
209975|NCT00592137|"     Lifestyle choices,including diet,are conducive to healthy body weights in children. Dairy     products and calcium supplementation have been associated with moderation of body weight and     body fat. This study was designed to test the following hypotheses with overweight and obese     adolescents consuming a controlled diet:        -  Dietary calcium supplementation as calcium carbonate or dairy calcium modulates energy          balance in adolescents.        -  Increased calcium in the diet of adolescents will increase fecal fat excretion and          thereby decrease fat absorption.        -  Calcium and dairy product supplementation will increase lipid oxidation resulting in an          increase in energy expenditure.   "
209976|NCT00592150|"     Hypothesis to be tested: Dopamine D1-like receptor-induced natriuresis is impaired in humans     with G protein-related kinase 4 gene variants.      Our research group has discovered a D1 receptor/adenylyl cyclase coupling defect in renal     PTCs from subjects with essential hypertension. We have found increased GRK-4 activity in     renal PTCs in human essential hypertension due to activating variants of GRK-4, an effect     that was reproduced in a transfected cell model. Preventing the translation of GRK-4     normalized the coupling of the D1 receptor to adenylyl cyclase in hypertension. Gene variants     of GRK-4 cause a ligand-independent serine-phosphorylation of the D1 receptor, resulting in     its uncoupling from the G-protein/effector complex. The desensitization of the D1 receptor in     the renal PTC is hypothesized to be the cause of the compromised natriuretic effect of DA     that eventually leads to Na+ retention and hypertension. The primary objective of this     protocol is to demonstrate that natriuresis engendered by D1-like receptor activation with     fenoldopam is blunted in subjects with 3 or more SNPs of GRK-4 compared with responses in     subjects with 0-2 SNPs.   "
209977|NCT00592163|"     A Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas   "
209978|NCT00592176|"     The purpose of this study is to determine whether local injection of bevacizumab might halt     and or cause regression of pterygium growth. This may enable earlier treatment and prevention     of pterygium growth into the patient's line of sight thereby limiting the need for surgery     and improving quality of life for patients with pterygia.   "
209979|NCT00592189|"     Is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair     safe and efficacious.      Will the incorporation of liposomal gene constructs to amnion enhance the functionality of     human amnion and improve wound repair.   "
209980|NCT00592202|"     The purpose of this study is to determine whether the LAP-BAND system is safe and effective     in morbidly obese adolescents.   "
209982|NCT00592228|"     Angiographic evaluation for intermediate lesions is not always accurate. Fractional flow     reserve-guided deferral strategy for these lesions showed the same event rate as routine     intervention strategy. However, proper FFR criterion for these lesions in the era of     drug-eluting stent is not known. This study sought to evaluate the clinical outcomes of     intermediate lesions according to FFR and compare those of FFR-guided intervention with     routine drug-eluting stent implantation strategy.   "
209983|NCT00592241|"     Diabetes mellitus (DM) is a multisystem disease with both biochemical and anatomical     consequences. Insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) is an     attractive way of treating patients with diabetes. The NiliMedix ADI Insulin Pump is an     ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous     delivery of insulin.      Insulin pumps require extensive user interaction because it is critical for treatment.     Avoidance of use-related risks that could harm the patient or impact the quality of the     treatment is important. Testing for ease and accuracy of use is the only way to ensure that     users can safely and effectively operate, install, and program and maintain the insulin pump     device.   "
209984|NCT00592254|"     The objective of this protocol is to establish a comprehensive screening process to evaluate     the eligibility of potential adult subjects for appropriate ADHD clinical research studies   "
209985|NCT00592267|"     The objective of this protocol is to establish a comprehensive screening process for the     evaluation of eligibility for entry in a clinical trial program for children and adolescents     with bipolar disorder.   "
209986|NCT00592280|"     The purpose of this project is to compare the effect of oxygenated preservation of the     pancreas before transplantation using the Two-Layer Method (TLM) against outcomes     previously experienced with organs preserved using only standard University of Wisconsin (UW)     storage solution. It is our hypothesis that TLM preservation will reduce the frequency and     severity of complications of pancreas transplantation, increase the number of organs     acceptable for transplantation, and spare individual patients and their families suffering     and hardship.   "
209987|NCT00592293|"     The main purpose of this study is to assess the short term and the long term side effects of     proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas.   "
209988|NCT00592306|"     The purpose of this study is to take a population of lung transplant recipients who meet UCLA     criteria for induction chemotherapy with thymoglobulin and prospectively study weather giving     the first dose intraoperatively versus postoperatively makes a difference with how patients     do during and after lung transplantation. In addition, these cohorts will be compared to     patients who do not qualify for thymoglobulin and receive either an alternative agent or no     agent. The primary endpoint is primary graft dysfunction. We will also evaluate several other     early and late end points such as ventilator days, ICU/hospital days, acute/chronic     rejection, infection, CT chest abnormalities, and survival.      We will also collect donor lung tissue and lavage fluid for measurement of various proteins     and receptor expression at two time points: (1) prior to implementation and dosing of     induction chemotherapy and (2) after transplantation (following a course of induction     chemotherapy). This will allow us to possibly make a connection between the profiles of the     various proteins and receptors and the clinical outcomes, depending on weather the patient     has received induction chemotherapy, starting intraoperatively or postoperatively.   "
210441|NCT00604344|"     This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of     insulin detemir on blood glucose control in subjects with insulin requiring diabetes.   "
209989|NCT00592319|"     Respiratory recurrent papilloma (RRP) is one of the most common benign tumors. Surgical     removal is the current management for RRP, but it is a very traumatic procedure, and often     leads to permanent voice dysfunction. In this study, we will develop a new, combined RRP     treatment with a pulsed dye laser (PDL) and Celebrex. We will determine if Celebrex, a newly     developed inhibitor of cyclooxygenase (COX)-2, can provide a long-term inhibitory effect on     RRP, therefore preventing RRP from recurring. This combined strategy, if successful in this     proposed study, will provide a new and ideal voice-preserving therapy for RRP that will     deliver long-term efficacy in managing RRP.   "
209990|NCT00592332|"     Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.   "
209991|NCT00592345|"     The purpose of this study is to test the effectiveness of high dose radiation administered by     both proton and photon therapy. Radiation is an effective treatment for many types of tumors     and it is thought that radiation alone, when given in much higher doses over a shorter period     of time, may be more effective in controlling recurrence of sarcoma.   "
209992|NCT00592358|"     This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the     treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or     Bipolar Spectrum Disorder. Specific hypotheses are as follows:      Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents with DSM-IV Bipolar     I, Bipolar II, or Bipolar Spectrum Disorder will be responsive to Invega treatment.      Hypothesis 2: Invega -associated improvement in bipolar disorder symptomatology in children     and adolescents will translate into improved functional capacities (neuropsychological,     social, and occupational), as well as an increased quality of life throughout treatment.      Hypothesis 2: Invega treatment will be safe and well tolerated as reflected by a low drop out     rate and absence of major side effects.   "
209993|NCT00592371|"     Head and Neck Squaumous Cell Cancer(HNSCC) is the 6th most common cancer in the United States     and the 3rd most common worldwide. Risk factors include abuse to tobacco and alcohol.     Survival is related to stage of HNSCC when treatment is sought. Most HNSCC patients present     with advanced staged disease. This screening activity will educate patients with HNSCC rick     factors and screen for pre malignant and/or early staged lesions.   "
209994|NCT00592384|"     Depression is likely the most prevalent and disabling psychological complication associated     with spinal cord injury (SCI). Yet no controlled depression treatment trials have been     performed in this population. The proposed study is a multi-site, randomized, double-blind,     placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and major     depressive disorder (MDD) or dysthymia who are at least one month post injury. Participants     will be recruited from four SCI Model System sites, the University of Washington,     Rehabilitation Institute of Chicago, University of Michigan, University of Alabama,     Birmingham and Baylor Institute for Rehabilitation, Dallas, TX. The purpose of the study is     to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The     primary outcome will be the percent of responders (those who report at least a 50% reduction     in depression severity from baseline to the end of treatment) in the venlafaxine XR versus     placebo control group using intent-to-treat analysis. Secondary outcomes will include changes     in pain, health related quality of life depression-related disability and community     participation. A successful clinical trial could lead to more aggressive identification and     treatment of MDD as well as improved health and quality of life in this important population.   "
209996|NCT00592410|"     We propose to determine the acute metabolic effects of intensive insulin therapy when     administered to AKI patients with a particular focus on its effects on protein metabolism. We     hypothesize that the degree of insulin resistance correlates with protein catabolism in     critically ill patients with AKI, and that intensive insulin therapy will result in     substantial reductions in both whole-body and skeletal muscle protein breakdown thereby     improving overall protein balance. We also hypothesize that this therapy will have favorable     effects on the inflammatory and oxidative stress profile of patients with AKI. The metabolic     response to these interventions will be assessed through stable isotope infusion techniques,     allowing for the most precise assessment of protein and energy homeostasis.   "
209997|NCT00592423|"     The primary aim of this study is to determine the changes in upper airway anatomy that occur     during lateral neck rotation and subsequent administration of continuous positive airway     pressure (CPAP) in anesthetized, spontaneously breathing children. The hypothesis for this     study is that neck rotation decreases overall upper airway volume because of constriction at     the level of the larynx, and that this constriction is relieved by administration of CPAP.   "
209998|NCT00592436|"     The objective of this protocol is to establish a comprehensive screening process to evaluate     the eligibility of potential pediatric subjects for appropriate ADHD clinical research     studies.   "
209999|NCT00592449|"     Osteoarthritis (OA) is one of the most common diseases and one of the leading causes of     disability in the world. People with OA frequently experience sleep disturbances, primarily     due to pain. Although insomnia is a known consequence of OA, recent studies have shown that     it may also worsen clinical pain by interfering with the body's responses to painful stimuli.     This study will evaluate the effectiveness of behavioral treatments for insomnia in reducing     sleep disturbances, thereby reducing clinical pain in people with knee OA. The study will     test whether improvement in clinical pain are mediated by changes in certain types of pain     processing.   "
210000|NCT00592462|"     The objective of this pilot study is to develop and evaluate a whole body MRI technique for     detecting cancer metastases. The whole body MRI will include T1-weighted and T2-weighted     phase-sensitive MR imaging as well as diffusion weighted imaging of the whole body in     multiple patient table stations.   "
210001|NCT00592475|"     To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic     patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic     response in patients with cirrhosis.   "
210002|NCT00592488|"     This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic     shock requiring vasopressors.   "
210066|NCT00599768|"     This prospective cohort and multi-site study aims to develop Taiwan version (ID Pain-T) based     on the original versions of ID Pain and also DN4, and validate both ID Pain-T and DN4 applied     in Taiwanese subjects at the clinical setting.   "
211149|NCT00618683|"     The purpose of this study is to determine/identify what mechanisms/factors are involved with     regard to AV nodal reentrant tachycardia.   "
210003|NCT00592501|"     Photon beam radiation is the standard type of radiation used to treat nasopharyngeal     carcinoma. Photon beam radiation enters the body and passes through healthy tissue,     encounters the tumor and leaves the body through healthy tissue. Proton beam radiation has     been shown to have the same effect on tumors as photon beam radiation but it enters the body,     passes through healthy tissue, and encounters the tumor but then stops. This means less     healthy tissue is affected by proton beam treatment than by photon beam treatment. The     purpose of this study is to determine the effectiveness of proton beam radiation in treating     nasopharyngeal cancer and reducing the acute and long-term side effects from the treatment.     This study will also test to see if the sparing of the healthy tissue can improve quality of     life   "
210004|NCT00592514|"     Specific Aim I: Determine absorption of iodine after oropharyngeal application of     povidone-iodine 10% solution when used in head and neck surgery involving the upper     aero-digestive tract.      Specific Aim II: Measurement of iodine induced changes in thyroid function.   "
210005|NCT00592527|"     This trial is conducted in Asia.      The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as     add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.   "
210006|NCT00592540|"     Phosphoglycerate kinase (PGK) deficiency is a rare x-linked disorder characterized by     hemolytic anemia, seizures, muscle fatigue, and progressive neurological dysfunction. The     disease is caused by the deficiency of PGK, an enzyme required for ATP formation through the     glycolytic pathway. PGK is an enzyme that is ubiquitous to all cells of the human body, but     red blood cells, muscles, and nerve cells are most severely affected by the absence of PGK     due to their reliance upon the glycolytic pathway. Mutations of the PGK gene are highly     variable and result in diverse phenotypes, ranging from mild hemolytic anemia only to severe     mental retardation and early death in childhood. The more severe phenotypes show progressive     neurologic deterioration between infancy and adolescence.      This is a 2 patient study aimed at studying the role of stem cell transplant in PGK     deficiency. Because the disease is so rare, the study will be limited to the 2 sibling     patients followed by our group, though it would be open to other participants who would meet     inclusion/exclusion criteria if such presented to us. The objective of this study is to     evaluate the feasibility and efficacy of stem cell transplants to treat patients with PGK     deficiency, Amiens subtype.   "
210007|NCT00592553|"     Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It     is caused by a mutation in the gene for dystrophin, a protein that is important for     maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility     that leads to weakness and loss of walking ability during childhood and teenage years. A     specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of     DMD/BMD in approximately 10-15% of boys with the disease. PTC124 is an orally delivered,     investigational drug that has the potential to overcome the effects of the nonsense mutation.     This study is a Phase 2b trial that will evaluate the clinical benefit of PTC124 in boys with     DMD/BMD due to a nonsense mutation. The main goals of the study are to understand whether     PTC124 can improve walking, activity, muscle function, and strength and whether the drug can     safely be given for a long period of time.   "
210008|NCT00592566|"     Background: Pulmonary involvement in leptospirosis has been reported to be on the increase     and is emerging as the main cause of death due to leptospirosis in many countries, including     Thailand.      Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone     as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with     leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.   "
228426|NCT00845741|"     This study is to evaluate the NGAL point of care device as an aid in the early risk     assessment of AKI (acute kidney injury)in an All-Comers ED population.   "
210009|NCT00592579|"     The purpose of the study is to determine the safety and effectiveness of providing     2-methoxyestradiol to patients with plateau phase or relapsed multiple myeloma. Information     regarding trough 2ME2 levels will also be collected.   "
210010|NCT00592592|"     The main purpose of this study is to see if using proton beam radiation therapy instead of     photon beam radiation therapy can reduce side effects from radiation treatment for     rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most     rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and     passes through healthy tissue, encounters the tumor, then leaves the body through healthy     tissue. A beam of proton radiation enters the body and passes through healthy tissue,     encounters tumor, but then stops. This means that less healthy tissue is affected by proton     beam radiation than by photon beam radiation.   "
210011|NCT00592605|"     Thyroid disease is more common among females and is increasing in incidence.      Otolaryngology faculty members and residents will perform head and neck examinations as part     of the subject's routine care. If the participant is noted to have thyroid disease, they will     be asked if they would like to participate in the research portion by having approximately     10cc's of blood drawn. Faculty and staff will complete a data collection sheet that will     contain demographic and clinical data.   "
210012|NCT00592618|"     Sleep studies in ESRD patients have identified increased prevalence of Sleep Apnea. Based on     current knowledge, treatment aimed at reducing oxidative stress might improve Sleep Apnea in     HD patients. The aim of our study is to investigate the effect of N-acetylsysteine on Sleep     Apnea in HD patients.   "
210013|NCT00592631|"     We hypothesize that the nocturnal use of continuous positive airway pressure in adults and     children with asthma will decrease airway reactivity.   "
210014|NCT00592644|"     Small vascular malformations (SVM) on the vocal fold is a common problem that can disturb the     voice. The pulsed dye laser (PDL) has been successfully used for treatment of blood vessel     abnormalities in surface tissue, through its high selectivity for destroying targeted blood     vessels while sparing normal tissue. However, there is no study to determine its clinical     benefit for treatment of SVMs on vocal fords. In this proposed study, we plan to make such a     determination.We will determine whether PDL will produce better and quicker voice improvement     than the conventional surgeries, in 20 patients (10 cases of each group) with vocal fold SVM.     We expect that this less invasive laser treatment will provide an ideal and excellent option     for this disease.   "
211152|NCT00618722|"     To evaluate the safety and potential efficacy of deoxycholic acid injection compared to     placebo for the reduction of submental fat (fat below the chin).   "
210016|NCT00592670|"     It is unclear what effect selective serotonin reuptake inhibitors (SSRIs) have on     hypoglycemia. Thus, the American Hospital Formulary Service recommends careful monitoring of     blood glucose levels in all patients with diabetes initiating or discontinuing SSRIs (Katz et     al., 1996). Because of the increased prevalence of depression in those with diabetes, it is     critical to discover what affect the antidepressant therapy may have on counterregulatory     responses to hypoglycemia. This study hypothesizes that chronic administration of SSRIs may     result in a blunted counterregulatory response to hypoglycemia, thereby leaving individuals     more susceptible to hypoglycemia.   "
210017|NCT00592683|"     This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to     open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV     criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as     follows:      Hypothesis 1: Omega-3 fatty acids will be well-tolerated and efficacious in the treatment of     children and adolescents with BPD      Hypothesis 2: The total dose of aripiprazole will be lower in those subjects receiving active     omega-3 treatment   "
210018|NCT00592696|"     It has been shown in the adult literature that smoking is related to depression and visa     versa. Not much is known about how this relationship is started or if one perhaps leads to     the other. We are performing 1 hour long interviews with adolescents ages 12-19 who meet     criteria for major depression and who smoke. They are interviewed along with their parent.     Questions center around their view of depression and their history of depression as well as     questions around their smoking as well as the interrelationships between the two. Transcripts     are made of the interview and are being analyzed for themes.   "
210019|NCT00592709|"     We are collecting brain tissue specimens and blood samples from patients at Vanderbilt     University Medical Center who are undergoing intracranial surgery to remove brain tissue,     including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery     for other non-cancerous types of brain tissus. These specimens will then be studied using a     novel microscopic laser-directed protein mass spectrometric analysis, looking for unique     protein signatures.   "
210020|NCT00592722|"     To establish a solid foundation, e.g. network and a coordinating centre for testing new SCI     therapies in forthcoming randomized controlled multi-centre clinical trials following     international standards and guidelines   "
210021|NCT00592735|"     This study will follow ,morbidly obese subjects as they undertake weight loss before and     after laparoscopic gastric banding, examining markers of glucose and lipid metabolism,     adipokines and measures of body fat.   "
210022|NCT00592748|"     The primary purpose of this study is to determine if the administration of a higher dose     would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with     a lower dose. Most of the treatment will be given protons, but participants may receive a     small portion of treatment with x-rays, because less radiation is given to the skin with     x-rays. This study uses two slightly different doses of radiation It is not clear at this     time which of the dose levels is better.   "
210023|NCT00592761|"     The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver     on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs     of pharyngeal dysphagia.   "
210024|NCT00592774|"     The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in     patients with Post-Herpetic Neuralgia (PHN).   "
210025|NCT00592800|"     To make medical decisions involving pros and cons, one also has to understand probability and     percentages. This is a preliminary study to evaluate the ability of children to understand     probability and percentages.   "
210026|NCT00592813|"     Background:      Many people who have suffered a hip fracture are discharged from rehabilitation services with     significant residual functional limitations and disability. We believe that a home-based     exercise program that incorporates cognitive-behavioral techniques to increase exercise     adherence and promote the return to daily activities could extend the benefits of formal     rehabilitation for patients who have suffered a hip fracture.      Specific Aims:      We will conduct a 5-year multi-site randomized controlled trial in patients who have suffered     a recent hip fracture and have completed all rehabilitation services. The specific aim that     this project will address is whether:      Participation in the Strong for Life (SFL) program will improve function and disability     outcomes in participants 6-months after they are discharged from rehabilitation services.      This study will also investigate the following secondary hypotheses:        1. Changes in function and disability at 6-month follow-up will be correlated with changes          in all three proposed intermediary variables: muscle strength, balance, and          self-efficacy.        2. The SFL program will significantly improve health-related quality of life among          participants at 6-month follow-up.        3. At 9-month follow-up the SFL program will continue to have a significant impact on          participants' function and disability compared to the control group.      Target population:      The target population will be people aged 60 years or more who have suffered a recent     traumatic hip fracture, have one or more residual functional limitations and have completed     all inpatient, outpatient or homecare rehabilitation services.      Intervention:      We will use an enhanced version of the Strong for Life program. This home-based exercise     program will include both resistance exercises using Thera-bands that will be shown on a     video/DVD and weight-bearing exercises that are progressed using a step and/or a weighted     vest. A cognitive-behavioral program that is customized for people recovering from hip     fracture is being developed that will focus on promoting exercise adherence, decreasing fear     of falling and increasing the return to daily activities in the patient's home and community.      Design:      A randomized controlled clinical trial will be implemented to measure the efficacy of the     Strong for Life program. An attention-control intervention will be provided to all     participants assigned to the control group. The outcome evaluation points are:        -  T0: baseline, at the point of discharge from formal rehabilitation;        -  T2: 6-month outcome assessment        -  T3: 9-month follow-up      Outcomes:      The primary outcomes will be function measured by both self-report (AM PAC) and physical     performance measures (SPPB). Secondary outcomes include disability, self-efficacy, balance,     strength, cognition, and reaction time. Adherence to the exercise program and adverse events     will also be monitored.   "
210027|NCT00592826|"     The study is divided in two stages. The purpose of the first stage is to evaluate the     percentage of subjects that can unpack the device, install it, learn the task and calibrate     it according to their personal capabilities. The purpose of the second stage is to assess the     ability of the subjects to perform reliable tests .   "
210028|NCT00592839|"     This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor     symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening     period and approximately 5 scheduled clinic visits. Participants will receive one of two     strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical     and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a     pap smear. Participants will be asked to wear a monitoring device for a portion of the study     and be asked to complete a daily dairy.   "
210112|NCT00601575|"     The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate     450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg     extended release tablet under fed conditions using a single-dose, randomized,     three-treatment, three-period, six-sequence crossover design.   "
210113|NCT00601588|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline     Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fed conditions using a     single-dose, 2-treatment, 2-period, crossover design.   "
210029|NCT00592852|"     This will be a 12-week open-label pilot treatment study for children and adolescents (ages     6-17) who meet DSM-IV criteria for bipolar disorder (BPD) and obsessive-compulsive disorder     (OCD) who are adequately mood stabilized on a stable regimen based on standard clinical care.     Specific hypotheses are as follows:      Hypothesis 1: Children and adolescents with comorbid OCD and BPD who have achieved adequate     mood stabilization using a naturalistic clinical practice approach, will benefit from an     FDA-approved selective seratonin reuptake inhibitor (SSRI) on their OCD symptoms in a     clinically meaningful way without exacerbation of bipolar symptoms.   "
210030|NCT00592865|"     Study Objective:      Brain tumors are poorly understood. The purpose of this research is to examine whether     factors in lifestyle play a role in brain tumor development. The study will also investigate     the contribution of inherited susceptibility to the risk of brain cancer. By gaining a better     understanding of these influences, the investigators hope to learn how to prevent brain     tumors in future generations, and to develop more effective strategies for treatment.      Study Protocol:      This is a case-control investigation. Persons affected with a brain tumor are compared to     unaffected persons on previous medical history, diet and other factors. Those enrolled in the     study will participate in an interview on general background, diet, medical history and     lifestyle, and will provide a sample of DNA, clippings of your toenails, and a tap water     sample from your home. All procedures are performed in the clinic or through the mail.      'Cases': Cases eligible for the study are persons with a recent diagnosis of a primary brain     tumor (glioma or meningioma), at least 18 years of age.      'Controls': Controls in the study are non-family members of patients, similar in age and of     the same gender. Suitable controls include in-laws, friends, neighbors and co-workers.   "
210031|NCT00592891|"     Hypothesis: That HBOT can be toxic in the low-pressure range.   "
210032|NCT00592904|"     The purpose of this study is to evaluate the safety, tolerability and continued efficacy of     perampanel in patients previously enrolled in double-blind, placebo-controlled studies for     Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN).   "
210033|NCT00592917|"     The purpose of this study is to determine the effect of calcium 1000 mg/d and vitamin-D3 800     IU/d divided in two daily doses on the incidence of falls and fractures, bone mineral density     and bone metabolism in postmenopausal women 65-71 years of age.   "
210034|NCT00592930|"     This study compared 10 weeks of treatment with olanzapine versus placebo in adolescent     females with anorexia nervosa-restricting type who were undergoing acute treatment on an     inpatient unit or a day hospital program that specializes in the treatment of eating     disorders.   "
210035|NCT00592943|"     The specific aims of this study are 1) to document the Dopamine Transporter (DAT) receptor     occupancy of armodafinil using positron emission tomography (PET) scanning with C-11     altropane as the ligand and 2) to document the increased intrasynaptic dopamine produced by     armodafinil using PET scanning with C-11 raclopride as the ligand. We hypothesize that DAT     occupancy will be low with armodafinil; less than the DAT occupancy produced by therapeutic     doses of methylphenidate. We also hypothesize that increases in intrasynaptic dopamine will     be relatively low with armodafinil.   "
210036|NCT00592969|"     This trial is conducted in South America. The aim of this trial is to evaluate the efficacy     of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects     with type 2 diabetes.   "
210037|NCT00592982|"     1. Bisphosphonate-associated osteonecrosis of the jaw(ONJ)is detectable by positron          emission tomography(PET).        2. Bisphosphonate-associated ONJ can be diagnosed and characteristically differentiated          from other bony pathologies of the jaw(osteomyelitis, osteolytic lesions, and          osteoradionecrosis)by PET imaging.   "
210085|NCT00601211|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine     Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fed conditions using a     single-dose, 2-treatment, 2-period, crossover design.   "
210086|NCT00601224|"     This study will determine the effectiveness of social cognition and interaction training, a     manual-based group therapy program, in helping people with schizophrenia improve their social     cognition and social functioning.   "
210038|NCT00592995|"     PRECREST is a two phase protocol for Huntington's disease in which 60 premanifest and at-risk     subjects will first be randomized into a double blind placebo controlled dose titration study     bringing them to 30 grams daily or their highest tolerated dose. This phase will establish     the highest tolerable doses in premanifest HD and permit the detection of toxicity and     intolerability with attribution to active compound versus placebo, and enable a dose response     assessment of biomarkers. In the second phase, all subjects will enter a year long open-label     treatment on 30 grams daily (or their highest dose) of creatine to assess long term exposure     to high dose creatine and its long term impact on various biomarkers.   "
210039|NCT00593008|"     The purpose of this research study is to try to define the highest doses of temsirolimus and     gemcitabine that can be used safely in combination to treat advanced pancreatic cancer.     Gemcitabine is a standard chemotherapy used for the treatment of pancreatic cancer.   "
210040|NCT00593021|"     Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by EGD     and colonoscopy, the presumed source of bleeding in these patients being the small intestine.     These patients fall under the category of obscure gastrointestinal bleeding, and frequently     require an extensive diagnostic work-up. For these reasons, most patients who present with     obscure or occult gastrointestinal bleeding typically undergo multiple endoscopic     evaluations, including capsule endoscopy and various radiologic imaging studies, including     enteroclysis, small bowel series, CT scan, angiography, and radionuclide scan. Recently, many     centers (included the Brigham and Women's Hospital) have begun using capsule endoscopy and CT     enterography (CTE) for evaluation of suspected small bowel pathology. This is an     observational study enrolling patients referred to the Brigham and Women's Hospital for     obscure gastrointestinal bleeding designed to compare the diagnostic yield of various     diagnostic modalities, in particular capsule endoscopy and CT enterography in the evaluation     of obscure gastrointestinal bleeding.   "
210114|NCT00601601|"     RATIONALE: Studying the genes expressed in samples of tissue from patients with abnormal     cells may help doctors identify biomarkers related to cancer.      PURPOSE: This clinical trial is identifying biomarkers for early detection of cancer in women     with cervical dysplasia or carcinoma in situ of the cervix.   "
210041|NCT00593034|"     This study will use the CCPT II to assess attention in 12-21 year olds enrolled in a     randomized controlled trial of a brief behavioral treatment for substance abuse.      This study will describe at baseline levels of attention using a well validated instrument     (Connors Continuous Performance Test II) and explore the association between attention levels     and substance use. The primary study hypothesis is that lower initial levels of substance use     (as measured by percent days abstinent) will be associated with higher attention levels. We     envision that this data will inform a better understanding of how attention may modify     treatment response.   "
210042|NCT00593047|"     Thyroid hormones are known to reduce cholesterol levels through regulation of a number of key     enzymes involved in synthesis, degradation, and lipid transport. However, the currently     marketed thyroid agonists are non-selective, and cannot be used for the treatment of     hypercholesterolemia due to extrahepatic consequences of hyperthyroidism, especially on     heart, bone, and muscle.      To take advantage of thyroid hormone effect on lipid metabolism for the treatment of     hypercholesterolemia, it is necessary to develop a selective thyroid receptor agonist that     can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the     extrahepatic tissue. KB2115 is a thyroid agonist developed to be liver selective.      The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to     low and middle doses of statin following 12 weeks of exposure compared to placebo. The aim of     the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 at     doses between 25 and 100 µg and to define a clinically relevant dose or dose range for future     studies.   "
210043|NCT00593060|"     In this study, the investigational drug, temsirolimus, will be combined with cetuximab, a     biologic agent used in the treatment of colorectal cancer. Cetuximab in combination with     temsirolimus may be more effective in treating advanced colorectal cancer than cetuximab     alone. The purpose of this research study is to try to define the highest dose of cetuximab     that can be used safely in combination with temsirolimus to treat advanced colorectal cancer     that has progressed through standard therapy.   "
210044|NCT00593073|"     Effective programs are needed that can overcome barriers to CRC screening among persons in     rural communities. There is good evidence to suggest that a program employing patient     activation and tailoring to address the specific concerns of individuals will be an effective     model for addressing CRC screening underutilization for rural residents. In this study, we     propose to test such a model among rural primary care patients, a group that has, to date,     received little attention. We will also bolster how tailored messaging is traditionally     conducted by using a tailored informational flyer format that uses physicians as the message     source to increase message saliency. This study will help to assess how a relatively     low-cost, disseminable technology can effectively circumvent the systems problems endemic     in rural primary care. This project will lay the groundwork in practice based research     network clinics for future intervention studies which operationalize office and     community-based technology to help rural primary care patients make informed health decisions     and engage in healthy lifestyle behaviors.   "
210045|NCT00593086|"     To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn     patients experiencing severe procedural pain during wound care.   "
210046|NCT00593099|"     The purpose of this pilot study is to determine the safety and potential efficacy of     sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients     with bipolar affective illness. It is hypothesized that bupropion will produce a significant     enhancement of smoking abstinence compared to placebo and will be safe for use in these     patients.   "
210047|NCT00593112|"     This will be an open label study using daily does of up to 126mg/day of Concerta in the     treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD.     Specific hypotheses are as follows:      Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC     Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine +     phosphocreatine (Glu/Cr) than matched HCS.      Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC     Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.   "
210087|NCT00601237|"     This study will develop and test the effectiveness of a cell phone-based text messaging     program to encourage abstinence, monogamy, or condom use among black urban males in     Philadelphia, Pennsylvania.   "
212190|NCT00630409|"     The purpose of this study is to test the hypothesis that the combination of gemcitabine and     doxil will have clinical activity in patients with metastatic renal cell carcinoma.   "
210048|NCT00593125|"     The proposed investigation will use methadone maintained patients who have concurrent cocaine     dependence in order to take advantage of the excellent (over 80%) treatment retention in this     patient group and to maximize treatment compliance by daily observed medication with both     methadone and levetiracetam. In the initial patients we will explore the tolerability of     escalating doses of levetiracetam as well as its potential role in reducing cocaine use, as     monitored by self-report and verified by three-times weekly urine toxicology testing in     methadone treated patients.The specific aim of this study is to evaluate the tolerability and     efficacy of levetiracetam 3 grams/day in modifying cocaine-using behavior, reducing cocaine     craving and attenuating cocaine's reinforcing effect among methadone-maintained patients   "
210064|NCT00599742|"     Previous studies report frequent comorbidity of anxiety and sensory-motor imbalance in adults     (Sklare et al., 2001). Only a few studies tested the comorbidity in children. We confirmed     that: a) children with primary diagnosis of poor balance demonstrate an elevated anxiety     level (Brat et al., 2006, submitted) and, b) children with primary diagnosis of generalized     anxiety disorder demonstrate poor balance performance (Erez et al., 2004). These studies     demonstrate the presence of balance-anxiety comorbidity in children with primary disorder of     either balance or anxiety. Our theoretical reasoning formalized under the three stage theory     of learning points to the possibility that poor balance may either predispose or cause the     emergence of anxiety disorder (Erez et al., 2004). Thus, in the present study we test two     predictions: (a) high prevalence of comorbidity of anxiety and balance disorders in children     with a primary diagnosis of generalized or separation anxiety disorder, and, (b) intensive     balance training, but not training of flexibility and power, will reduce the level of anxiety     in children with primary diagnosis of anxiety.   "
239754|NCT00997594|"     The purpose of this study is to evaluate changes in adrenal hormones during adrenal     radiofrequency (RF) ablation.   "
210049|NCT00593138|"     The objectives of this study are to document the pharmacokinetics of the adequacy of DAT     receptor occupancy d-MPH formulation in three doses (20 mg, 30 mg, and 40 mg) using PET     scanning with C-11 Altropane as the ligand across a range of times. It has been estimated     that MPH is effective when the average CNS DAT occupancy is 50% or greater. Focalin XR has     been shown to be clinically effective in an analog classroom as early as 1 hour and as late     as 12 hours. Therefore, it is hypothesized that the average DAT occupancy will be adequate     (50% or greater) at time periods corresponding to the times of clinical efficacy.      The first objective is to examine the onset of action by testing whether average DAT     occupancy will be adequate (50% or greater) at 1 hour after dosing for each dose tested (20     mg, 30 mg, 40 mg).      The second objective is to test the adequacy of average DAT occupancy in a range of later     times for each dose. The times chosen (8, 10 and 12 hours) correspond to times Focalin XR has     been shown to be clinically effective in an analogue classroom study. A range of times have     been chosen since, while effective at 12 hours, the degree of clinical effectiveness     decreased with later time periods. The adequacy of DAT occupancy across this range of time     periods will provide important details on the in vivo molecular action of the medicine at     periods of critical clinical activity.      The third exploratory objective is to examine a time period later then those previously     tested with the highest dose. Since the clinical effectiveness of Focalin XR has not been     tested out to 14 hours, it is unknown whether it is effective at 14 hours. If Focalin XR were     to be effective at 14 hours it would be more likely at the highest dose.   "
210050|NCT00593151|"     The purposes of the PLUS study were to confirm the safety and tolerability of two doses of     LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior     anti-HCV therapies (Panels A and B), and then to continue to study the safety, tolerability,     and preliminary efficacy of the same two doses of LocteronTM (320 ug and 640 ug) in     treatment-naïve genotype 1 HCV patients when Locteron dosed over 12 weeks (Panel C). All     subjects were also to receive oral daily weight-based ribavirin.   "
210051|NCT00593164|"     This study will involve the use of therapeutic hypothermia. This prospective cohort pilot     study will evaluate the clinical performance of a new device, the ThermoSuit™ System, to     achieve therapeutic hypothermia in comatose patients following resuscitation from cardiac     arrest, and the impact of the vasodilator, magnesium sulfate, on cooling performance and     hemodynamics in these patients. The study hypothesis is that magnesium sulfate will     significantly increase the rate of cooling.   "
210052|NCT00593177|"     The primary objective of the study is to assess the tolerability and efficacy of a 0.10% or     0.05% PTH (1-34) parathyroid hormone peptide gel in the treatment of mild to moderate plaque     psoriasis in comparison to treatment with the placebo gel alone.   "
210053|NCT00593190|"     Intracameral Gas SF6 (Sulfur Hexafluoride) Injection for Acute Hydrops in Keratoconus   "
210054|NCT00593203|"     The Molecular Neurosurgical Tissue Bank will function as a tissue or specimen repository for     biopsy specimens from patients (both adult and pediatric) undergoing brain surgery and brain     procedures. Leftover tissue removed during the course of brain surgery will be collected and     stored in neurosurgical laboratories for use in medical research that might be currently     ongoing or for future research. In addition, blood and cerebral spinal fluid samples will     also be collected and stored. Leftover cerebral spinal fluid (CSF) will be collected during     standard of care procedures (lumbar punctures or ventricular drains) that take place at time     of diagnosis, completion of therapy and relapse of disease or during neurosurgery. Blood will     be drawn at time of routine lab draws required during the surgery or procedure.   "
210055|NCT00593216|"     The purpose of this study is to determine the potential usefulness of new functional MRI in     diagnostic assessment of patients presenting with vertigo.   "
210056|NCT00593229|"     This registry will collect clinical data and store biosamples (seru, plasma, urine, and DNA)     annually from pediatric patients with thrombotic mcroangiopathy   "
210057|NCT00599651|"     In this protocol we will conduct a randomized controlled trial where babies with respiratory     distress syndrome (RDS) who have not yet reached criteria for intubation, will be randomized     to receive surfactant by LMA or to continue receiving standard therapy of nasal CPAP and     supplemental oxygen. All babies will be given surfactant by endotracheal tube if they reach     failure criteria, which is the standard criterion for surfactant administration (i.e.,     FiO2= 65% while receiving nasal CPAP).      The objective of this RCT is to determine if surfactant can be successfully administered by     LMA, thus perhaps avoiding the need for endotracheal intubation. The hypothesis is that fewer     babies in the LMA group would reach failure criteria.   "
210058|NCT00599664|"     Evaluate the safety and systemic absorption of OMS201 following exposure during ureteroscopy.   "
210059|NCT00599677|"     The purpose of the study is to testify the efficacy of treating functional dyspepsia with     acupuncture, and provide evidence for the hypothesis that Acupuncture effect is based on     meridians, and gathering of meridian Qi is the key point.   "
210060|NCT00599690|"     To evaluate the confocal microscopy findings at the corneal epithelium and anterior stroma     after epi-LASIK Surgery.   "
210061|NCT00599703|"     The purpose of this study is to use an imaging method called functional magnetic resonance     imaging (fMRI) in patients who have a tumor near an area of the brain that is believed to     control language. The fMRI is a new kind of imaging that uses a strong magnetic field to look     at functioning brain tissue. This kind of imaging will be used to study the effect of the     brain tumor on your speech.   "
210158|NCT00602199|"     RATIONALE: ABT-510 may stop the growth of melanoma by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well giving ABT-510 works in treating patients     with metastatic melanoma.   "
210062|NCT00599716|"     The study is designed to assess the safety and efficacy of Vismed®, a special eye drop     containing sodium hyaluronate, in the treatment of dry eye syndrome. Vismed® is being     compared to another eye drop, identical in composition except that it does not contain the     active ingredient, sodium hyaluronate. This eye drop is designed as the vehicle. Some     subjects are to receive Vismed® treatment, while others are to receive the vehicle; the     assignment of subjects to receive either Vismed or vehicle is to be random. The two-week     treatment phase is followed by a one week follow-up period to evaluate safety of Vismed®.   "
241326|NCT01019551|"     Viral eradication in selected HIV-infected patients is possible with intensive antiretroviral     therapy plus immunomodulation   "
210067|NCT00599781|"     This study investigated the safety and efficacy of different gene therapy approaches for     Severe Combined Immunodeficiency (SCID) caused by the deficiency of adenosine deaminase (ADA)     enzyme. This is a severe condition that can be cured by HLA-matched sibling donor bone marrow     transplantation. Patients were enrolled if no HLA-identical sibling donor was available and     the patient showed evidence of failure of enzyme replacement therapy or this treatment was     not a long-term available option. The aim of the study was to evaluate the safety and     efficacy of the procedure and to identify the relative role of peripheral blood lymphocytes     and hematopoietic stem cells and progenitor cells in the long-term reconstitution of immune     functions after retroviral vector mediated ADA gene transfer.   "
210068|NCT00599794|"     Patients may have actual or relative intravascular volume depletion in a number of different     disease states, particularly with sepsis syndrome. However, it is clinically difficult to     determine volume status without invasive monitoring, which may cause unintended     complications. Our hypothesis is that we can accurately estimate central venous pressure,     which is a surrogate marker of volume status, with a noninvasive portable ultrasound device.   "
210069|NCT00599807|"     This is a 2-year double-blind randomized controlled trial in 287 community-dwelling     individuals age 60 years or older undergoing uni-lateral total knee replacement due to severe     OA of the knee.We compare an oral dose of 2000 IU vitamin D3 per day to 800 IU. The primary     endpoints are pain and disability related to rehabilitation of the operated knee,and related     to the expected high prevalence of OA in the contra-lateral knee. Secondary endpoints are     change in 25(OH)D levels, muscle strength, balance, lower extremity function, the rate of     falls, bone density and bone quality, bone metabolism, general pain, fall-related fractures,     body composition, blood-pressure, major cardiovascular events, blood glucose-insulin levels,     executive cognitive function, rate of upper respiratory tract infections / all infections,     tooth loss, dental health, health care utilization, number and size of facial skin keratosis,     and radiographic progression of the non-operated knee. Pain and disability will be assessed     by the pain and function subscales of the Western Ontario- McMaster Universities     Osteoarthritis Index (WOMAC). Randomization will be stratified by WOMAC function prior to     surgery, radiological evidence for OA in the contra-lateral knee, and hospital. Clinical     visits will take place at baseline (6-8 weeks after TKR), at 6, 12, 18 and 24 months of     treatment. In addition, all individuals will receive a phone call every 2 month to assess     adverse outcomes and compliance to treatment, supported by a hotline for immediate report of     adverse events.      Statistical power: We expect more than 80% power with 200 participants completing their 24     month follow-up, and 260 participants completing their 12 month follow-up.      This is a trial with medicinal product.   "
210070|NCT00599820|"     Intravitreal Bevacizumab is an effective treatment for choroidal neovascularization secondary     to Angioid Streaks   "
210071|NCT00599833|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Radiation therapy uses high energy     x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of     radiation directly to the tumor may kill more tumor cells and cause less damage to normal     tissue. Giving cetuximab together with 3-dimensional conformal radiation therapy may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation     therapy works in treating patients with locally advanced pancreatic cancer that cannot be     removed by surgery.   "
210072|NCT00599846|"     The objective of the 18-month trial is to evaluate the natural history of geographic atrophy     by assessing the rate of progression of the geographic atrophic lesion over time.   "
210088|NCT00601250|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to     metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control   "
210089|NCT00601263|"     The purpose of this study is to determine the safety of an anti-asthma herbal medicine     intervention (ASHMI) in adult asthmatics and to see what effects ASHMI has on certain parts     of the immune system.   "
210073|NCT00599859|"     The genetics of lactase divides the population into 2 phenotypes: Those who can(LP) and those     who cannot(LNP)digest lactose. This division may help modify disease risks according to     geographic population distribution. At least some of the putative mechanism of risk     modification may relate to an effect of undigested lactose on lower intestinal bacteria. The     effect may provide for support of beneficial microbes. The amount of lactose reaching the     colon is made easier in LNP than LP subjects who have to consume larger amounts to have     meaningful spillover into the lower bowel.The current study examines whether there are     quantifiable qualitative fecal bacterial differences to a standard intake of lactose(milk     sugar)between these 2 different phenotypic populations. Finding of differences would lend     support to the notion that for some diseases LP and LNP subjects face different risks even in     an area of uniform disease risk if they consume lactose (found in dairy foods).      The primary end point is comparison of 4 groups of specific bacteria between LP and LNP     participants before and after 2 weeks of lactose(in powder form mixed in water) consumption.     Classification is based on genetic analysis and secondarily on breath hydrogen results.     Results are compared within groups.      The secondary outcome is comparison of 4 groups of bacteria between LP and LNP subjects     against each group of stool samples obtained on the first visit. Results are obtained between     groups.      Additional information and other secondary outcomes are to evaluate any relationship between     diet intake and the 4 groups of bacteria on the first visit      Another outcome will be to compare within groups any effect of lactose consumption on insulin     and glucose levels within the 2 groups.   "
210074|NCT00599872|"     The purpose of this study is to determine an effective dose range for the administration of     ragweed allergenic extract via the sublingual route of administration   "
210126|NCT00601757|"     This study will evaluate the effectiveness of an interpersonal therapy treatment called the     Postpartum Prevention Program in preventing the development of postpartum depression in     pregnant women who are financially disadvantaged.   "
210127|NCT00601770|"     The objective is to investigate the virological (HCV-RNA) responses following biweekly     immunization with IC41.      Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.   "
210075|NCT00599885|"     People with diabetes mellitus are more prone to coronary heart disease, stroke, and     peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk     factor for the progression of coronary artery disease. Several studies have been reported     that diabetes increased the risk of cardiovascular mortality in both men and women. With the     introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later     months have reduced dramatically in several studies. However, even with DESs, diabetic     patients showed increased rates of restenosis and late loss index compared with nondiabetic     patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous     coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes     after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been     demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era     of DESs, no study has compared the effects of telmisartan and valsartan on neointima volume     with intravascular ultrasound (IVUS) at 8 months after zotarolimus-eluting stent implantation     in hypertensive type 2 diabetic patients. Telmisartan, which is well-known for its selective     peroxisome proliferator-activated receptor (PPAR)-γ activity with its anti-inflammatory and     antiproliferative properties, could be an appropriate therapeutic option for treating     hypertensive diabetic patients with significant coronary artery diseases requiring stent     implantation. In contrast, valsartan is an angiotensin receptor blocker with negligible     PPAR-γ activity. Increasing interest remains in the identification of systemic     pharmacological therapies to prevent coronary restenosis especially in diabetic patients.   "
210076|NCT00599898|"     The purpose of this study is to investigate the efficacy and the safety of nifedipine     compared to atosiban for treating preterm labor.   "
210077|NCT00599911|"     The primary purpose of this study is to assess the efficacy in treating patients with Major     Depressive Disorder of one or more doses of Lu AA24530 relative to placebo   "
210078|NCT00599924|"     This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate,     SUTENT) in combination with FOLFOX [Leucovorin + Fluorouracil (5-FU) + Oxaliplatin]. Three     different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2,     Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors,     including colorectal cancer.   "
210079|NCT00599937|"     Objectives of the trial were to assess the optimal timing of chemotherapy with or after ATRA     and the role of maintenance therapy.   "
210080|NCT00599950|"     To evaluate the confocal microscopy changes in keratocyte density at the anterior stromal     after Photorefractive keratectomy (PRK) surgery, using intraoperative mitomycin C(Mitolem,     LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA).   "
210081|NCT00599963|"     Immunoglobulin A (IgA) nephropathy is the common type of primary glomerulonephritis in the     world. A wealth of literature suggests that vitamin D and its analogs have profound effects     on immune system function and glomerular mesangial cell proliferation. However, calcitriol,     the standard form of vitamin D, carries a substantial risk of hypercalcemia. Recently,     paricalcitol (19-nor-1,25-dihydroxyvitamin D2) was approved for the treatment of secondary     hyperparathyroidism in chronic renal failure, and the incidence of hypercalcemia is much     lower than calcitriol. Therefore, the investigators plan to conduct a randomized cross-over     study to evaluate the efficacy of paricalcitol in the treatment of IgA nephropathy. Thirty     patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to     paricalcitol for 12 weeks or no treatment, followed by cross over to the other arm after a     washout period. Proteinuria, renal function, serum and urinary inflammatory markers will be     monitored. This study will explore the potential anti-proteinuric and anti-inflammatory     effects of paricalcitol in the treatment of IgA nephropathy, which has no specific treatment     at present.   "
210082|NCT00599976|"     For patients with atrial fibrillation and heart failure, current treatment can include AV     nodal ablation with biventricular pacing. Pulmonary vein isolation (PVI) is a new procedure     for this patient population which attempts to restore sinus rhythm. This trial is a     randomized controlled trial of AVN ablation with biventricular pacing versus PVI for atrial     fibrillation patients with congestive heart failure.   "
210083|NCT00601185|"     The purpose of this study is to evaluate a new instrument that shines light and takes digital     pictures of skin. The goal is to develop a technique that may enable fast and accurate     detection of skin disorders and cancers for future clinical diagnosis and surgical use.   "
210084|NCT00601198|"     The purpose of this study is to determine the effect of amifostine (ETHYOL) on decreasing the     rate and severity of nerve dysfunction or neuropathy (numbness and tingling in hands and     feet) associated with FOLFOX chemotherapy.   "
210090|NCT00601276|"     Sexual abuse committed on children is a major public health problem because of its frequency     and its severe consequences on the mental health of victims.      Objective: to compare the therapeutic efficacy of cyproterone acetate (CPA) and leuprolide,     with the hypothesis that leuprolide will be more effective.   "
210091|NCT00601289|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients     with invasive pituitary tumors.   "
210092|NCT00601302|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine     Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fed conditions using a     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.   "
210093|NCT00601315|"     The objective of this study was the bioequivalence of a potential generic 250 mg     clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin     tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.   "
210094|NCT00601328|"     The objective of this study was to assess the bioequivalence of Roxane Laboratories'     Calcitriol capsules, 0.25 mcg, to ROCALTROL® capsules, 0.25 mcg (Roche) using a single-dose,     2-treatment, 2-period, crossover design, under fasting conditions   "
210128|NCT00601796|"     The purpose of this study is to find out what effects (good and/or bad) a tumor vaccine used     in combination with two drugs (ATRA and cytoxan) have on the patient and their cancer. We     also want to find out if the vaccine and the drugs can boost the patient's immune system and     how their immune system reacts, both before and after the vaccine treatment.   "
210095|NCT00601341|"     The purpose of this study is to gain a better understanding of the effects of lumbopelvic     manual therapy on lower extremity biomechanics and arthrogenic muscle response. As a result     of this study, we also hope that physical therapists, athletic trainers, and other physical     medicine rehabilitation providers will gain a better understanding of lower extremity     injuries and have the scientific evidence to provide patients with techniques which would     allow for efficient return to activities of daily living without restrictions and possibly     prevent future injuries and minimize risk of osteoarthritis.      The objectives of this study are to:        -  Determine the amount and duration of arthrogenic muscle response of quadriceps muscles          following lumbopelvic joint manipulation.        -  Determine the effects of lumbopelvic joint manipulation on temporospatial parameters of          gait such cadence, step length, velocity and mean peak lower extremity joint moments.        -  Determine if a correlation exists between patellofemoral joint pain and lumbopelvic          joint dysfunction.        -  Determine the amount of change in clinical outcome measure scores following lumbopelvic          joint manipulation.   "
210096|NCT00601354|"     This study will evaluate the effectiveness of adding guided self-help group therapy to a     weight loss program in achieving weight loss and reducing binge eating in overweight binge     eaters.   "
210097|NCT00601367|"     Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose     regimens   "
210098|NCT00601393|"     This study will evaluate the effectiveness of an Internet-based cognitive behavioral therapy     program in treating mothers with depression who have young children.   "
210099|NCT00601406|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients will respond to treatment.      PURPOSE: This clinical trial is evaluating DNA mutations in predicting the effect of     external-beam radiation therapy in patients with early breast cancer, localized prostate     cancer, or gynecologic cancer.   "
210100|NCT00601419|"     Post marketing drug use investigation of Genotropin for GHD-ADULTS.   "
210101|NCT00601432|"     The main purpose of the study was to evaluate the effect of food on the single-dose     pharmacokinetics of an oral solution of levofloxacin.   "
210102|NCT00601445|"     The purpose of this study is to test the hypothesis that sleep homeostasis, also known as     sleep pressure or sleep drive, is different in healthy older and younger individuals.   "
210103|NCT00601458|"     We are interested in whether bunionectomy can be used as a model to study the treatment of     acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS)     medications (such as ibuprofen) and other pain relieving drugs. We are interested to know if     this model is useful to study other drugs for the treatment of acute pain. The other drugs     being tested in this study are pregabalin and naproxen sodium. These drugs are approved for     use by the Food and Drug Administration (FDA). This study is designed to test whether these     two drugs are effective in treating pain after a bunionectomy.   "
210104|NCT00601471|"     The overall aim of this project is to determine the effect of a tibiofibular joint     manipulation on the neuromuscular response of the fibularis longus and soleus muscles in     individuals with chronic ankle instability. Another aim of this study is to determine the     long term effects of a tibiofibular joint manipulation on range of motion and self-reported     function.      We hypothesize that a manipulation applied at the distal tibiofibular joint will result in     greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores     compared to a tibiofibular joint manipulation applied at the proximal joint. We further     hypothesize that both distal and proximal tibiofibular joint manipulations will result in     greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores     than no treatment at all.   "
210105|NCT00601484|"     The purpose of this study is to determine whether PF-04383119 is effective in the treatment     of pain associated with interstitial cystitis.   "
210106|NCT00601497|"     The purpose of this study is to find out whether electrical stimulation can reduce knee pain     and increase function in people with osteoarthritis of the knee.   "
210107|NCT00601510|"     RATIONALE: Imatinib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as capecitabine and cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving imatinib together with combination chemotherapy may kill more     tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of imatinib when given     together with capecitabine and cisplatin in treating patients with unresectable or metastatic     stomach cancer.   "
210108|NCT00601523|"     The general aim of this study is to obtain long-term safety and tolerability data on     pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have     previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or     248.636(NCT00558025) trial).   "
210109|NCT00601536|"     The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg     extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release     tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period,     2-sequence crossover design.   "
210110|NCT00601549|"     This is a three-year research project. The major aims of this study are to:(1) compare the     functional recovery and oncologic results in patients with advance rectal cancer treated by     either traditional open or laparoscopic methods by randomized prospective clinical trials;(2)     investigate the presence of tumor cells in the peripheral blood of patients undergoing either     laparoscopic or open surgery; (3) searching for the clinicopathologic features of advanced     rectal cancer after CCRT; (4) conduct the translational research regarding the difference of     gene expression and its prognostic significance in advanced rectal cancer before and after     chemoradiation therapy by micro-array analysis methods; (5) exploration of the potential stem     cells of colorectal cancer using CD-133 cell surface marker.   "
210111|NCT00601562|"     The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg     tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fed conditions using a     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.   "
210164|NCT00602290|"     This study will evaluate the safety and effectiveness of methylphenidate in improving     cognition and function in older adults with depression.   "
210115|NCT00601614|"     RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as temozolomide, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving vandetanib together with     temozolomide may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and     temozolomide in treating patients with advanced solid tumors that cannot be removed by     surgery.   "
210116|NCT00601627|"     RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     fluorouracil, capecitabine, and gemcitabine, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. External-beam     radiation therapy uses high-energy x-rays to kill tumor cells. Panitumumab may also stop the     growth of pancreatic cancer by blocking blood flow to the tumor and make tumor cells more     sensitive to radiation therapy. Giving panitumumab together with chemotherapy and radiation     therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving panitumumab together with     chemotherapy and external-beam radiation therapy works in treating patients with locally     advanced pancreatic cancer that cannot be removed by surgery.   "
210117|NCT00601640|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged     skin.      PURPOSE: This randomized phase II trial is studying the side effects and how well     eflornithine works compared with diclofenac, given alone or together, in treating patients     with sun-damaged skin.   "
210118|NCT00601653|"     This study will evaluate the effectiveness of adding nutritional counseling to cognitive     behavioral therapy in treating obese people with binge eating disorder.   "
210119|NCT00601666|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem     Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions     using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.   "
210120|NCT00601679|"     This will be a multicentre Phase IV study in which patients with chronic HF who are managed     and followed by HF/heart functions clinics will be followed over a period of two years.      Clinic patients who are recruited into the study will have obligatory blood sampling for the     surveillance measurement of NT-proBNP level every three months for a minimum of one year (4     samples). One-half of the subjects in each clinic will be randomized to have these NT-proBNP     values made known to the attending clinic physicians and nurses, the other half will have     these values blinded. During the study, attending clinic physicians can order open-label     NT-proBNP or BNP assays, if available in their institution, to assist the management of their     patients if they feel it is clinically needed.   "
210121|NCT00601692|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells.     Irinotecan and docetaxel may also make tumor cells more sensitive to radiation therapy.     Giving combination chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when     given together with irinotecan and radiation therapy with or without cisplatin in treating     patients with locally advanced esophageal cancer.   "
210137|NCT00601913|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how patients will respond to treatment with     erlotinib.      PURPOSE: This clinical trial is studying how well erlotinib works when given before surgery     in treating patients with head and neck cancer that can be removed by surgery.   "
210906|NCT00613379|"     The purpose of this study is:        1. To assess and characterize the PK and PD of PRO 140 administered IV        2. To assess the antiviral activity of PRO 140        3. To assess the safety and tolerability of PRO 140   "
210122|NCT00601705|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin, oxaliplatin, fluorouracil, and     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed. Giving chemotherapy and radiation therapy     after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy, surgery,     and radiation therapy works in treating patients with locoregionally advanced cancer of the     esophagus, gastroesophageal junction, or stomach.   "
210123|NCT00601718|"     This phase I/II trial is studying the side effects and best dose of vorinostat when given     together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well they work     in treating patients with relapsed or refractory lymphoma or previously untreated T-cell     non-Hodgkin lymphoma or mantle cell lymphoma. Vorinostat may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and     etoposide, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving vorinostat together with rituximab and     combination chemotherapy may kill more cancer cells   "
210124|NCT00601731|"     The purpose of this study is to evaluate how well the immuno response against meningococcal     serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.   "
210125|NCT00601744|"     The goal of this research study is to learn about the social and emotional factors that may     affect the quality of life of patients with cancer of the eye or eye area who have had their     facial appearance changed due to an orbital exenteration.   "
243894|NCT01052129|"     An open label randomised, two-treatment, two-period, two-sequence, single-dose, crossover,     comparative bioequivalence study.   "
210129|NCT00601809|"     Adhesive small intestine obstruction (ASIO) is an important cause of hospital admission and a     very common disease. Any improvement in this field will benefit many patients by reducing the     operative rate. Patients with this disease are difficult to evaluate and to manage and their     treatment is controversial. Emergency surgery is mandatory when strangulation is suspected or     in the case of total obstruction. On the other hand, conservative non-operative treatment is     indicated in the case of partial obstruction. The role of water-soluble contrast medium     (Gastrografin®: GG) in ASIO is still debated with regard to the therapeutic value.      The aim of our study was to determine the therapeutic role of Gastrografin in patients with     small intestine obstruction without strangulation caused by adherences (ASIO).   "
210130|NCT00601822|"     This study will evaluate the effectiveness of adding cognitive remediation therapy to     cognitive behavioral therapy for treating people with anorexia nervosa.   "
210131|NCT00601835|"     To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus     and Diphtheria Toxoids Adsorbed vaccine to the seroprotection rates and booster responses to     the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to     subjects ≥ 60 years of age.      To compare the post-vaccination geometric mean titers of antibody (GMTs) to Canadian     manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the post-vaccination GMTs to     the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to     subjects ≥ 60 years of age.   "
210132|NCT00601848|"     RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by     tumor cells. The drug becomes active when it is exposed to light. When the drug is active,     tumor cells are killed. Giving photodynamic therapy during surgery may kill any tumor cells     that remain after surgery.      PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy     given during surgery works in treating patients with resectable non-small cell lung cancer     that has spread to the pleura.   "
210133|NCT00601861|"     The trial is conducted in Europe. This trial aims for a comparison of the pathology in lymph     nodes before and after the effect of recombinant interleukin-21 in patients with stage III     melanoma   "
210134|NCT00601874|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine     Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fasting conditions using a     single-dose, 2-treatment, 2-period, crossover design.   "
210135|NCT00601887|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam     tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fed conditions using a     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.   "
210136|NCT00601900|"     This randomized phase III trial studies tamoxifen citrate or letrozole together with     bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in     treating women with stage III or stage IV breast cancer. Estrogen can cause the growth of     breast cancer cells. Hormone therapy using tamoxifen citrate* or letrozole may fight breast     cancer by blocking the use of estrogen by the tumor cells. Monoclonal antibodies, such as     bevacizumab, may help control breast cancer by stopping the growth of blood vessels to the     tumor. It is not yet known whether giving hormone therapy is more effective with or without     bevacizumab in treating advanced breast cancer.   "
210156|NCT00602173|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol     Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions     using a single-dose, randomized, 3-treatment, 3-period, crossover design.   "
210138|NCT00601926|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of kidney cancer by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in     treating patients with unresectable or metastatic kidney cancer.   "
210139|NCT00601939|"     This study will evaluate the effectiveness of culturally competent psychoeducational     empowerment sessions in treating suicidal African-American women who are in abusive     relationships.   "
210140|NCT00601952|"     The purpose of this study is to determine whether a computerized intervention designed to     change the nature of attention biases will be effective in reducing the symptoms of post     traumatic stress disorder (PTSD) in American combat veterans returning from the wars in     Afghanistan and Iraq.   "
210141|NCT00601965|"     This study will assess whether adding cognitive behavioral therapy to the antidepressant     escitalopram is effective in reducing anxiety in older adults with generalized anxiety     disorder.   "
210142|NCT00601978|"     This study will evaluate the effects of immediate release (IR) carbidopa levodopa versus the     effects of immediate-release carbidopa/levodopa on ERP parameters in patients with idiopathic     PD.   "
210143|NCT00601991|"     RATIONALE: Aflibercept may stop the growth of cancer cells by blocking blood flow to the     cancer.      PURPOSE: This phase II trial is studying how well aflibercept works in treating patients with     advanced refractory, relapsed, or untreated acute myeloid leukemia.   "
210144|NCT00602004|"     The primary objective is to determine if the use of losartan, an angiotensin II receptor     blocker, can attenuate left ventricular hypertrophy, independent of its antihypertensive     effects, in patients with near end stage chronic kidney disease (CKD) who have an     arteriovenous fistula created.      Secondary outcomes include the impact of the medication on BNP and hyperkalaemia   "
210145|NCT00602017|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine     Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fasting conditions using a     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.   "
210146|NCT00602030|"     The purpose of this study is to evaluate the safety and efficacy of SNDX-275 in combination     with erlotinib in the treatment of Advanced Non-Small Cell Lung Cancer.   "
210147|NCT00602043|"     This phase II trial is studying how well F-18 16 alpha-fluoroestradiol (FES) imaging works in     predicting response to first-line hormone therapy in women with hormone receptor-positive     metastatic breast cancer. Diagnostic procedures, such as FES imaging, may help predict how     well patients will respond to hormone therapy and may help plan the best treatment.   "
210148|NCT00602056|"     The objective of the study was to assess the effect of 1) redesigned immunization card, 2)     center-based education to mothers, and 3) redesigned card with center-based education to     mothers, provided at DPT1, on DPT3 completion in a randomized controlled trial at rural     Expanded Programme on Immunization (EPI) centers in Karachi, Pakistan.   "
210149|NCT00602069|"     This study will evaluate the effectiveness of a brief cognitive behavioral treatment, Helping     to Overcome PTSD through Empowerment, in treating abused women with post-traumatic stress     disorder who are living in shelters.   "
210150|NCT00602082|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, streptozocin, and cisplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. It is not yet known whether giving capecitabine together with     streptozocin is more effective with or without cisplatin in treating neuroendocrine tumors.      PURPOSE: This randomized phase II trial is studying giving capecitabine together with     streptozocin to see how well it works compared with or without cisplatin in treating patients     with unresectable or metastatic neuroendocrine tumors.   "
210151|NCT00602095|"     This is a randomised study aimed at comparing the currently most frequently used     prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective     prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and     randomised to one of the three methods. The main outcome measures were time to delivery, rate     of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol     would be superior to the other methods.      The main finding of our trial was that the catheter showed the shortest induction to delivery     interval. There were no differences between the two other prostaglandins. No differences in     maternal and neonatal outcome was found   "
210152|NCT00602108|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     intraoperative radiation therapy after lumpectomy followed by external-beam radiation therapy     may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying the side effects and how well radiation therapy     works in treating women undergoing lumpectomy for stage I or stage IIA breast cancer.   "
210153|NCT00602134|"     The objective of this study was to assess the bioequivalence of a potential generic     6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol®     (mercaptopurine) 50-mg scored tablets following a single 50 mg oral dose administered in the     fasted state.   "
210154|NCT00602147|"     RATIONALE: Studying blood or mouthwash samples in the laboratory from patients receiving     melphalan for cancer may help doctors learn more about changes that occur in DNA, identify     biomarkers related to cancer, and help predict how patients will respond to treatment.      PURPOSE: This clinical trial is studying common genetic mutations related to mucositis in     patients with multiple myeloma receiving high-dose melphalan.   "
210155|NCT00602160|"     The increasing prevalence of allergic diseases in westernized countries poses a significant     health problem and a tremendous burden on quality of life and healthcare expenditure. Food     allergy affects as many as 6% of young children and 3% to 4% of adults. While the majority of     children outgrow their allergy to milk, egg, wheat and soy, allergies to peanut, tree nuts,     fish and shellfish are often life-long. Currently, there are no treatments that can cure or     provide long-term remission from food allergy. Based on our preliminary studies, we     hypothesize that our investigational botanical drug, FAHF-2TM, will be a safe and effective     herbal therapy for food allergy. We are enrolling those age 12-45 yrs old with allergies to     peanut, tree nuts, sesame, fish, and/or shellfish.   "
210159|NCT00602212|"     Generalized Anxiety Disorder (GAD) is a psychiatric disease characterized by long-lasting     anxiety that is not focused on a specific object or situation. According to the DSM-IV-TR the     essential feature of GAD is at least six months of excessive anxiety and worry about a     variety of events and situations. Anxiety and worry are often accompanied by a variety of     physical symptoms like restlessness, being easily fatigued, difficulty concentrating,     irritability, muscle tension and disturbed sleep. The high prevalence of GAD in the general     population and the severe limitations it causes point out the necessity to find new     strategies to treat it in a more efficient way. Within the treatment of GAD, physical     (relaxation and controlled breathing), behavioral (visualization and controlled exposure) and     cognitive control strategies (challenging negative thoughts) represent a key part of the     treatment, even if they are hard to be learned. Given the features of this disease and its     pervasive effect on patient's personal, occupational and affective life, we thought it could     benefit from an ubiquitous treatment.We suggested, then, to improve the treatment of GAD     through the use of a biofeedback enhanced virtual reality (VR) system used for relaxation,     controlled exposure and SIT. The use of SIT in the context of GAD is motivated by the     acknowledgment that sometimes stressors can't be avoided or altered and then patients can't     apply strategies focused on finding solutions. In these instances, coping effort should be     directed to emotionally palliative set of responses such as acceptance, reframing and     perspective thinking. All these cognitive changes are facilitated if a concomitant relaxation     is induced. The treatment involves two virtual reality components:      I) an immersive virtual reality system experienced in the therapist's office;      II) a mobile exposure system allowing patients to perform the virtual experience in an     outpatient setting. The role of the mobile exposure system is the following:        -  To present and structure emotionally relevant contents in an ubiquitous context.        -  To verify the compliance of the patient and eventually alert patient/therapist;        -  To track in real-time the emotional level of the patient and record it for later          assessment by the therapist;        -  To provide a feedback to the patient able to help him in coping with the contents;        -  To automatically contact the therapist if the emotional level is higher than a preset          cut-off value defined by the therapist.   "
210160|NCT00602225|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or stopping them from     dividing. Colony stimulating factors, such as G-CSF, may increase the number of immune cells     found in bone marrow or peripheral blood and may help the immune system recover from the side     effects of chemotherapy.      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine to see     how well it works when given together with cytarabine and G-CSF in treating patients with     relapsed or refractory acute myeloid leukemia   "
210161|NCT00602251|"     The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine     tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fed     conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover     design.   "
210162|NCT00602264|"     The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and     ghrelin in different stages of anorectic patients and to evaluate their relationships between     biochemical, hormonal and anthropometric parameters.   "
210163|NCT00602277|"     This phase I/II trial is studying the side effects and best dose of viral therapy in treating     patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer     that did not respond to platinum chemotherapy (phase II closed as of 1/7/2011). Viral therapy     may be able to kill tumor cells without damaging normal cells.   "
210165|NCT00602303|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide     Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fasting conditions using a     single-dose, 2-treatment, 2-period, crossover design.   "
210166|NCT00602316|"     RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging, may     help doctors learn the extent of disease and plan the best treatment.      PURPOSE: This clinical trial is studying how well multifunctional magnetic resonance imaging     works in predicting breast lesions in women undergoing mastectomy for breast cancer.   "
210167|NCT00602329|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab     may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving     bevacizumab together with combination chemotherapy may kill more tumor cells. Diagnostic     procedures, such as MRI, may help doctors predict a patient's response to treatment and help     plan the best treatment.      PURPOSE: This randomized phase II trial is studying how well MRI works in predicting response     to combination chemotherapy given together with bevacizumab in treating patients with     advanced or metastatic colorectal cancer.   "
210168|NCT00602342|"     The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine     tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under     fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence     crossover design.   "
210169|NCT00602355|"     This study will evaluate the effectiveness of antidepressant medication alone and     interpersonal psychotherapy alone in treating women with postpartum depression.   "
210170|NCT00602368|"     RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and     diagnose cervical intraepithelial neoplasia.      PURPOSE: This clinical trial is studying digital colposcopy to see how well it works in     finding cervical intraepithelial neoplasia.   "
210171|NCT00602381|"     The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate     450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg     extended release tablet under fasting conditions using a single-dose, randomized,     three-treatment, three-period, six-sequence crossover design.   "
210172|NCT00602394|"     The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg     extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release     tablet under fed conditions using a single-dose, randomized, 2 treatment, 2-period,     2-sequence crossover design.   "
210173|NCT00602407|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol     Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions     using a single-dose, randomized, 2-treatment, 2-period, crossover design.   "
210355|NCT00596323|"     The researchers' long-term goal is to develop a small implantable device that can continually     monitor glucose levels. This will be an antenna. Changes in the glucose levels in will affect     the antenna signals and those can be used to predict the patient's glucose levels.   "
210174|NCT00602420|"     RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not     yet known whether naproxen is more effective than a placebo in preventing bone pain caused by     pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.      PURPOSE: This randomized phase III trial is studying naproxen to see how well it works     compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with     non-hematologic cancer undergoing chemotherapy.   "
210175|NCT00602433|"     Studying samples of blood in the laboratory from patients receiving erlotinib may help     doctors learn more about the effects of erlotinib on hormone levels.      This clinical trial is looking at hormone changes in women with stage IIIB or stage IV     non-small cell lung cancer receiving erlotinib.   "
210176|NCT00602446|"     RATIONALE: Deferasirox may be effective in treating iron overload caused by blood     transfusions in patients who have undergone donor stem cell transplant.      PURPOSE: This phase II trial is studying the side effects and how well deferasirox works in     treating patients with iron overload after donor stem cell transplant.   "
210177|NCT00602459|"     This randomized phase II trial studies how well fludarabine (fludarabine phosphate) and     rituximab with or without lenalidomide or cyclophosphamide work in treating patients with     symptomatic chronic lymphocytic leukemia. Drugs used in chemotherapy, such as fludarabine     phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different     ways by targeting certain cells. Lenalidomide may stimulate the immune system in different     ways and stop cancer cells from growing. Giving fludarabine phosphate and rituximab together     with lenalidomide or cyclophosphamide may be an effective treatment for chronic lymphocytic     leukemia.   "
210178|NCT00602472|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to     metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with     insufficient glycaemic control.   "
210179|NCT00602485|"     This will be a pilot study of the effect of an Action Control-based intervention (ACBI) on     adherence to prescribed diet and exercise programs after cardaic rehabilitation. The purposes     of this study are to:        1. determine if an ACBI has an effect on adherence to prescribed home exercise and diet          regimens for individuals 6 weeks after participating in a cardiac rehabilitation program        2. examine whether there is a difference in response to the ACBI between state-oriented          individuals and action-oriented individuals.        3. test the interaction effect between action-orientation disposition and the intervention.   "
210180|NCT00602498|"     The objective of this study was the bioequivalence of a potential generic 500 mg     clarithromycin tablet formulation compared with Abbott Laboratories 500 mg clarithromycin     tablet, Biaxin® following a single 500 mg dose, administered with food.   "
211153|NCT00618735|"     The purpose of the study is to see if daily and twice daily administration of BIIB021 is     tolerated in patients with advanced solid tumors.   "
210181|NCT00602511|"     The purpose of the study is to compare thalidomide + dexamethasone with bortezomib +     dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main     goal is to find out which of these two 2:nd line regimens that offers the patients the best     chance for a response with as long duration and as good quality of life as possible.   "
210182|NCT00602524|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine     tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fasting conditions using a     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.   "
210183|NCT00602537|"     This study will compare the safety and effectiveness of antidepressant therapy versus mood     stabilizing therapy in treating people with bipolar type II major depression.   "
210184|NCT00602550|"     The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg     tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fasting conditions using a     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.   "
210185|NCT00602563|"     Generalized Anxiety Disorder (GAD) has high prelevance (up to 8.5%; Roy-Byrne & Wagner, 2004)     and leads to functional impairment (Wittchen et al., 2002; Ballenger et al., 2001).     Researchers have demonstrated a relationship between attention bias to threatening     information and GAD. However, this knowledge has not yet been translated into effective     treatments. The goal of this project is develop and test a new computerized treatment for     Generalized Anxiety Disorder.   "
210186|NCT00602576|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. Giving temozolomide together with sorafenib     may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying two different schedules of temozolomide     when given together with sorafenib to compare how well they work in treating patients with     metastatic or unresectable melanoma.   "
210187|NCT00602589|"     The primary objective of the study was to assess the bioequivalence of the oral suspension     formulation, the oral solution formulation, and the marketed tablet formulation of     levofloxacin, with the marketed tablet as the reference.   "
210188|NCT00602602|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy     uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with combination     chemotherapy and radiation therapy may kill more tumor cells.      PURPOSE: The phase II trial is studying the side effects and how well giving bevacizumab     together with gemcitabine, oxaliplatin, fluorouracil, and radiation therapy works in treating     patients undergoing surgery for locally advanced pancreatic cancer.   "
210189|NCT00602615|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide     Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fed conditions using a single-dose,     2-treatment, 2-period, crossover design.   "
210907|NCT00613392|"     Administration of antioxidants to trauma patients will improve measures of oxidant stress in     the blood   "
210190|NCT00602628|"     RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging and CT     scans, may help reduce normal tissue damage in patients undergoing radiation therapy for     cancer.      PURPOSE: This clinical trial is studying how well radiation therapy planning techniques work     in reducing damage to normal tissue in women undergoing breast-conserving surgery for ductal     breast carcinoma.   "
210191|NCT00602641|"     This randomized phase III trial studies melphalan and prednisone with thalidomide to see how     well it works compared to melphalan and prednisone together with lenalidomide in treating     patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan     and prednisone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Thalidomide and lenalidomide may stop the growth     of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether     melphalan and prednisone are more effective when given together with thalidomide or     lenalidomide in treating multiple myeloma.   "
210192|NCT00602667|"     RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat     brain tumors in young children. Using chemotherapy gives the brain more time to develop     before radiation is given. The chemotherapy in this study includes the drug methotrexate.     This drug was an important part of the two clinical trials which resulted in the best     survival results for children less than 3 years of age with medulloblastoma. Most patients     treated on this trial will also receive radiation which is carefully targeted to the area of     the tumor. This type of radiation (focal conformal or proton beam radiotherapy) may result in     fewer problems with thinking and learning than radiation to the whole brain and spinal cord.      PURPOSE: This clinical trial is studying how well giving combination chemotherapy together     with radiation therapy works in treating young patients with newly diagnosed central nervous     system tumors.   "
210193|NCT00602680|"     The primary objective of the study is to assess the effect of 3 doses of SSR180711C on     cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to     assess the safety/tolerability of SSR180711C in patients with mild AD.   "
210194|NCT00602693|"     RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body     irradiation before a donor umbilical cord blood transplant helps stop the patient's immune     system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor     effect). Giving an infusion of the donor's T-regulatory cells after the transplant may     decrease this effect. Sometimes the transplanted cells from a donor can also make an immune     response against the body's normal cells. However, the donor immune system may also react     against the recipient's tissues (graft-versus-host disease).      PURPOSE: This phase I trial is studying the side effects and best dose of donor T-regulatory     cells after an umbilical cord blood transplant in treating patients with advanced hematologic     cancer or other disorder.   "
210195|NCT00602706|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the     growth of cancer cells either by killing the cells or by stopping them from dividing.     Samarium Sm 153 lexidronam pentasodium contains a radioactive substance that kill cancer     cells. Peripheral blood stem cell transplant using stem cells from the patient may be able to     replace immune cells that were destroyed by chemotherapy and radioactive drugs used to kill     cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153     lexidronam pentasodium when given together with high-dose melphalan in treating patients with     multiple myeloma undergoing stem cell transplant.   "
210196|NCT00602719|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem     Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fed conditions using     a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.   "
210197|NCT00602732|"     This study will evaluate the effectiveness of an interpersonally oriented treatment program     called Reach Out for a Safe Environment in preventing depression and post-traumatic stress     disorder in low-income pregnant women who have experienced recent partner abuse.   "
210198|NCT00602745|"     The primary objective of this study is to determine whether S-1 increases overall survival     when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer     previously treated with a gemcitabine-based therapy.      The secondary objectives are to compare: progression free survival, overall response rate,     clinical benefit and improvement in tumor related symptoms and also to assess overall safety     and pharmacokinetics of S-1.   "
210199|NCT00602758|"     This study will compare the effectiveness of enhanced counseling alone versus enhanced     counseling combined with observed therapy at improving medication adherence in people with     HIV.   "
210200|NCT00602771|"     This randomized phase II trial is studying the side effects and how well giving tipifarnib     together with etoposide works in treating older patients with newly diagnosed, previously     untreated acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving tipifarnib together with etoposide may kill more cancer     cells.   "
210201|NCT00602784|"     The objectives are        1. to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization          with HCV antigen peptide vaccine with polyarginine.        2. to document virological (HCV-RNA) and biochemical (ALT) responses following immunization          with HCV antigen peptide vaccine with polyarginine.        3. to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.   "
210202|NCT00602797|"     This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel     works in treating older patients with advanced non-small cell lung cancer. Drugs used in     chemotherapy, such as vinorelbine tartrate and paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     combination chemotherapy may kill more tumor cells.   "
210226|NCT00603148|"     This study will begin to define these critical determinants for patients undergoing     procedures in the hybrid interventional cardiology/cardiac surgery suite. In future studies,     the data obtained from this study will be used to prospectively stratify patients in terms of     bleeding verses thrombotic risk to design studies to optimize anticoagulation and     anti-platelet therapies in the hybrid setting.   "
210203|NCT00602823|"     The pathogenesis of psoriasis has evolved from epidermal hyperproliferation to immune     dysregulation in recent years. A Th1 cytokine profile is universally found is psoriasis.     Biologics targeting the immune system have become the focus of study. Raptiva (Efalizumab) is     one of biologics indicated for the treatment of psoriasis, and is the first biologic approved     for use in psoriasis in the EU (EMEA). In USA, it is the second biologic drug (after Amevive)     for psoriasis. Raptiva is a humanized chimeric antibody of CD11a (LFA-1), which blocks the     interaction of CD11and ICAM─1, thus preventing lymphocyte trafficking. It is used for     moderate to severe chronic plaque type psoraisis. The first clinical trial of Raptiva in     Asians iscurrently done in the department of Dermatology, National Taiwan University Hospital     and the incidence of psoriatic arthritis (either de novo or aggravation of preexisting     psoriatic arthritis) is significantly higher than previously reported in Western     countries（30％ versus 7%，and personal communication with doctors in Hong-Kong and Singapore     also reveals a similar safety profile. It seems likely that a racial difference is present.     Monocytes play a central role in the pathogenesis of psoriatic arthritis. It is thus     intriguing to study the pathogenesis of Raptiva-induced aggravation of psoriatic arthritis by     comparing the difference of monocyes response in the presence of Raptiva between patients     with and without Raptiva-induced psoriatic arthritis. In further study, the CD11a genomic     polymorphism will also be investigated. The suudy can provide us with important information     on how a novel monoclonal antibody like Raptiva can have both therapeutic and detrimental     actions on psoriasis. The short term benefit of the study will be in pharmacogenomics and     pharmacoeconomics, finding the best candidates for the expensive drug. The long term goal     will be the clarification of the pathogenesis of psoriasis and psoriatic arthritis.   "
210204|NCT00602836|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop     the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving     rituximab together with combination chemotherapy and lenalidomide may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with pentostatin,     cyclophosphamide, and lenalidomide works in treating patients with previously untreated     B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.   "
210205|NCT00602849|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline     Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fasting conditions using a     single-dose, 2-treatment, 2-period, crossover design.   "
210218|NCT00603044|"     The purpose of this research is to find out how a nasal spray (fluticasone furoate),     sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain     cells within a child's adenoids. We hypothesize that intranasal steroids lead to an     upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will     result in a local reduction in inflammation and edema explaining the improvement in OSAS.   "
210299|NCT00590187|"     The main objective of this study is to learn which sapacitabine treatment is more likely to     keep the cancer in check for at least one year in AML patients who are at least 70 years of     age or older and in MDS patients who are at least 60 years of age.   "
210206|NCT00602862|"     Sorafenib is a tyrosine kinase inhibitor that is registered for the treatment of metastasized     clear cell Renal Cell Carcinoma (ccRCC). It inhibits signal transduction of the Vascular     Endothelial Growth Factor Receptor (VEGFR) and the Platelet Derived Growth Factor Receptor     (PDGFR). In the tumorigenesis of ccRCC, VEGF and PDGF are upregulated due to the defective     Von-Hippel-Lindau (VHL) gene. CcRCC has a high Interstitial Fluid Pressure (IFP) and Tumor     Microvascular Density (TMD), hampering the delivery of chemotherapeutics and monoclonal     antibodies (mAbs). It was hypothesized that antiangiogenic compounds decrease tumor IFP and     TMD, thus normalizing tumor vasculature, before diminishing tumor vasculature. Bevacizumab is     an anti-VEGF mAb which depletes soluble VEGF from plasma, depriving VEGFR of its ligand.     Chimeric monoclonal antibody cG250 recognizes carbonic anhydrase IX (CAIX), an antigen that     is abundantly expressed in Renal Cell Carcinoma (RCC) and has limited expression in normal     tissue. The aim of this study was to investigate the effect of Sorafenib on ccRCC physiology,     by determining tumor uptake of 111In labeled cG250 or 111In labeled Bevacizumab.   "
210207|NCT00602901|"     The purpose of this study is to compare the clinical effectiveness of two types of     chiropractic spinal manipulation to conservative medical care for patients at least 55 years     old with sub-acute or chronic low back pain (LBP).   "
210208|NCT00602914|"     The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics     injected via the MicronJet in comparison with a conventional needle.   "
210209|NCT00602927|"     This project aims to define mechanisms through which varenicline might be an effective     smoking cessation medication.   "
210210|NCT00602940|"     This is a randomized control trial of acupuncture for women with polycystic ovary syndrome.     The study is triple-blinded.   "
210211|NCT00602953|"     The study evaluates if fat accumulates in the pancreas in individuals at risk of developing     obesity-related diabetes. It also evaluates if the amount of fat in the pancreas can predict     the residual functional capacity of the pancreas (insulin secretion).   "
210212|NCT00602966|"     Oocyte cryopreservation has been studied for many years without much success in refining a     method that has consistent, reliable results in producing viable embryos and clinical     pregnancies. In 1986 the first baby was born from an embryo created from a frozen oocyte;     however, since then there have been less than 150 births from frozen eggs. To date, there are     no reportable adverse outcomes in the children born from frozen oocytes. The research     continues to look at different methods of oocyte cryopreservation. Many smaller studies have     been conducted with some success but larger clinical trials are needed to replicate these     findings. The conventional cryopreservation technique has been slow cooling with differing     methods of freezing; however, vitrification is now being researched as the potential     cryopreserving method that holds some promise for the future.      Our hypothesis is the use of vitrification (quick freezing) to cryopreserve oocytes in     patients undergoing in-vitro fertilization will be more successful than slow freezing in     oocyte survival, fertilization rate with ICSI and subsequent embryo development, implantation     rate and pregnancy rate.   "
210213|NCT00602979|"     The placement of endotracheal tubes (intubation) is a physiologically stressful procedure for     patients. Laryngoscopes are devices-typically composed of a blade attached to a handle with a     light source—that allow examination of the upper airway through the mouth, often for the     purposes of intubation. Recently some new laryngoscope devices (including the Airtraq®     Optical Laryngoscope, the Storz DCI Video laryngoscope®, McGRATH® Video Laryngoscope, and the     GlideScope®) have been developed, which may either decrease the stress related to intubation     (reduce neck extension, reduce risk of complications or reduce time elapsed during     intubation) or improve intubation success (reduce the number of attempts at intubating). Data     are being collected in this study to determine which of these commonly-used devices may be     better, particularly in comparison to the current hospital standard, the Macintosh     laryngoscope. All of the devices to be used in this study are currently cleared or exempt by     the Food and Drug Administration (FDA).   "
210244|NCT00603395|"     This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip     Resurfacing System.   "
210214|NCT00602992|"     Gamma Knife radiosurgery is a non-invasive technique for the delivery of a single, high dose     of radiation to an intra-cranial target. MRI has an established and central role in the     treatment planning process and assessment of response to intracranial radiosurgery.     Increasing the field strength of MRI from 1.5T to 3T promises to improve the signal, and in     turn the quality of images. However, the technology also introduces new limitations, and the     role and safety of 3T MRI in the management of patients receiving radiosurgery has not yet     been reported. In this pilot study, we will explore the spatial integrity, and incremental     image-guidance utility of 3T MRI in patients receiving radiosurgery. The preliminary data     acquired in this study will be instrumental to the judicious design and conduct of subsequent     definitive clinical trials. Up to fifty patients will be enrolled in this study.   "
210215|NCT00603005|"     The purpose of this study is to study the effect on intraocular pressure in glaucoma patients     using the TravAlert dosing aid with or without the Eyot drop guider and with or without     additional patient education.   "
210216|NCT00603018|"     Several studies in the past suggest that individuals who have or had anorexia nervosa may     have alterations in brain serotonin. Serotonin seems to play an important role in regulating     anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology     called Positron Emission Tomography (PET), which is a method used to take pictures of the     body, in this case, the brain. Study participants will undergo two baseline PET scans on the     first day of the study. The women who have recovered from anorexia will then be given a     medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th     week, they will return for a third PET scan. By comparing the brain scans, before and after     fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the     serotonin receptors in the brain. We will be comparing brain serotonin system in women who     have recovered from anorexia before and after medication in order to gain a better     understanding of changes in the serotonin system associated with eating disorders. This study     may help shed light on how to make fluoxetine a more effective treatment for anorexia     nervosa.   "
210217|NCT00603031|"     study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal     stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified     as having no residual beta cell function left.   "
210219|NCT00603057|"     Successful treatment of non-small cell lung cancer with radiation therapy requires that the     physicians determine exactly where the tumor is in your body and protect your normal tissue.     This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission     Tomography (FDG-PET) and Ventilation/Perfusion Single Photon Emission Computerized Tomography     (V/Q SPECT), before treatment and then again during treatment to see if it helps predict how     well the treatment works for your cancer and how well your lung functions during treatment. A     Computerized Tomography (CT) will also be performed along with both of these procedures to     help the researchers see clearly where your cancer or your healthy lung is located.      The researchers are also doing blood tests in this study to look for markers in your blood     and to see if it helps them in determining your risk of developing side effects from     radiation to the lungs. The researchers hope that this study will help them in the future to     design radiation treatment plans that provide the best treatment for each individual patient.   "
210220|NCT00603070|"     The purpose of this study is twofold:        1. to measure the effects of transitioning from one electronic prescribing system to          another in the ambulatory setting on medication errors and human-computer interactions        2. to evaluate the impact of electronic transmission of discharge medication lists to the          ambulatory setting on medication discrepancies and adverse drug events   "
210221|NCT00603083|"     The purpose of this study is to determine whether the investigator standardized pain     treatment plus local pain treatment is more effective than the investigator standardized pain     treatment plus placebo in total hip arthroplasty.   "
210222|NCT00603096|"     The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in     OHS patients after one month of NIV treatment depending upon the tools used for adjusting     settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at     awakening whereas in the other arm patients will benefit from a complete polysomnography     under NIV.   "
210223|NCT00603109|"     The purpose of this study is to evaluate the effect of rimonabant, a cannabinoid receptor-1     blocking drug, on the appetite, body weight, body fat and growth hormone level of subjects     with Prader-Willi Syndrome (PWS). This will be a double blind placebo controlled clinical     trial involving a total of 18 young adults aged 18 to 35 years with PWS. Patients will be     divided in to the two groups of control and intervention, and treated with either placebo     (inactive drug), or rimonabant 20 mg once a day for a total duration of 6 months. Body     weight, fat distribution, objective and subjective assessment of the hunger, fasting blood     sample for measurement of ghrelin and leptin (two hormones regulating appetite), serum lipids     , IGF-1(growth hormone related protein), insulin and glucose concentrations will be measured     upon enrollment, at 3 months, and at the end of the study. The proportion of body fat to     muscle will be determined using a radiological technique, whole body dual-energy x-ray     absorptiometry (DEXA) scan, and also by measurement of skin fold thickness, waist and hip     circumference at the enrollment prior to the intervention, and at the end of the study.   "
210224|NCT00603122|"     The trial evaluates the role of ascent protocol on acute mountain sickness and     cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of     mountaineers ascend with different acclimatization time to the summit. The prevalence and     severity of symptoms of acute mountain sickness are evaluated along with physiologic     variables.   "
210225|NCT00603135|"     Status epilepticus (SE) represents the most common life-threatening neurological emergency     requiring treatment on an intensive care unit. The incidence in Western European countries is     about 12-18/100'000. Immediate and effective treatment of SE is obviously essential because     of the deleterious effects of continuous seizures on the brain and the whole organism.     Guidelines emphasize the use of benzodiazepines (BZD) as first-line anticonvulsive drugs.     Alternatively, i/v Phenytoin (PHE), fosphenytoin (FOS), and valproate (VPA) were also tested     as first-line anticonvulsants in SE. Direct comparison of PHE with lorazepam (LZP) showed     significant superiority of LZP (evidence class I). Other trials i/v PHE or -VPA are of     evidence class III or IV. BZD, VPA, and PHE have clinical and pharmacological disadvantages.     BZD may cause respiratory depression or sedation and may be not suitable for patients with     COPD or ambiguous in patients with BZD addiction. Some compounds also may induce     tachyphylaxis or accumulate under concomitant renal failure. PHE has saturable metabolism     subject to Michaelis-Menten kinetics increasing the risk of overdosing in an acute setting     causing liver damage, serious cardiac arrhythmias, hypotension, cerebellar degeneration,     peripheral neuropathy and local/systemic skin reactions. Although of unequivocal efficacy,     PHE should no longer be used for long-term because of its adverse effects after chronic     administration (irreversible cerebellar degeneration causing debilitating ataxia, painful     polyneuropathy, and osteopenia increasing the risk of fractures). Metabolism by and     self-induction of the hepatic CYP450 system make PHE prone to interactions with several other     drugs, notably other antiepileptics. VPA may cause liver failure, hemorrhagic complications,     pancreatitis, and hyperammonemic encephalopathy. To summarize, these three first-line agents     for the treatment of SE may cause serious side effects in several patients with SE.      Levetiracetam (LEV) is broad-spectrum antiepileptic drug. It binds to the presynaptic     vesicular protein 2A abundantly present in different regions of the brain; LEV     presynaptically modulates transmitter release, but the exact mechanism(s) remain unclear.     Data also revealed that LEV stabilizes GABAA receptors upon repetitive activation what is     important in treatment of SE because GABAA receptors undergo significant changes of subunit     conformation within minutes after sustained activation like during SE. These changes render     GABAA receptors the less anticonvulsive, the longer SE lasts. Levetiracetam has a favorable     pharmacological profile with large safety margins. Its partly extrahepatic hydrolyzation     bypasses the CYP450 system; renal excretion is 60-70% unchanged, and 23-27% metabolized.     Dosage needs adjustment when renal function is impaired. LEV lacks interactions with any     drugs yet. Drowsiness is the most common side-effect while respiration, liver and kidney     function, and the blood system are not affected. LEV shows an important clinical effect even     after the first dose and maximal efficacy within the first week of drug-intake. The favorable     clinico-pharmacological profile predilects LEV for the first-line treatment of SE, especially     in patients with multi-organ failure, sepsis, coma etc.. About 10 % of comatous patients may     be in non-convulsive SE (NCSE) on ICU's. These patients are under polymedication whereby     interactions of the anticonvulsants approved yet for the treatment of NCSE with their other     drugs may have fatal effects. Conversely, non-interacting anticonvulsants would represent an     advantage for the treatment of NCSE for these patients.      Recently, the i/v formulation of LEV was approved by the FDA for the use in patients, but not     specifically for the treatment of SE. Data about the single-dose bioavailability of i/v-LEV     in comparison to oral tablets as well as multiple-dose pharmacokinetics and tolerability in     healthy subjects were recently published. In addition, the administration of i/v-LEV dosages     ranging from 2000-4000 mg within 15 minutes and of dosages ranging from 1500-2500 mg within 5     minutes was safe and well tolerated, and led to efficacious drug levels in a randomized,     single-blind, placebo-controlled safety and pharmacokinetic study in healthy volunteers.      Slight somnolence is expected to be the only adverse effect of i/v LEV, sharply contrasting     with the sedation up to coma after i/v benzodiazepines. Thus, even severely ill patients will     be accessible to neurological tests under LEV which is a big advantage in this clinical     difficult setting of NCSE.      I-v LEV is considered an ideal candidate for the first-line use (before benzodiazepines) in     patients with NCSE, especially in those with important comorbidity and concomitant     polymedication. Thus, we would like to test the feasibility, safety, and efficacy of i/v-LEV     as first-line medication in a open-label, single-center, prospective pilot study as outlined     below.   "
210366|NCT00596466|"     This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when     administered by itself (without any other anti-epileptic medication) to epilepsy patients for     the treatment of partial seizures. This is an extension study to a previous clinical trial.   "
210227|NCT00603174|"     The present protocol will demonstrate the feasibility and efficacy of a newly developed mode     of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA.     During NAVA, the timing and magnitude of pressure delivered are controlled by the infants'     diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive.     Recent clinical trials in adults and term infants have shown that NAVA is more synchronous     than conventional pressure support ventilation, and that NAVA delivers lower mean airway     pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently     been approved for use in infants by Health Canada and the FDA in the United States, and is     commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The     present protocol is designed as a case study where the researchers responsible would like     to evaluate the feasibility and efficacy of ventilating an infant on NAVA with the Servoi for     12 hours, and to compare it to conventional ventilation.   "
210228|NCT00603187|"     We propose oral dosing of gastrointestinal permeation enhancement technology [GIPET] enhanced     oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose)     pharmacokinetics of oral acyline in four normal, healthy young men.   "
210229|NCT00603200|"     The purposeof this study is to determine the effect of a large volume paracentesis (procedure     in whihc a catheter is placed to remove fluid from the abdomen) on the severity of fatigue i     patients with cirrhosis (severe scarring of the liver) and large volume ascites (fluid in the     abdomen).   "
210230|NCT00603213|"     Congestive heart failure is a condition in which the heart is weakened and is unable to pump     enough blood to the organs of the body to meet the demands of the body. At times there may be     a buildup of fluid in the lungs, legs or other parts of the body. The accumulation of this     fluid has been shown to affect the resistance to flow of the electrical impulses generated in     the heart. The purpose of this study is to correlate measurements to the passive flow of     electricity generated by the heart within the chest (as measured by the Optivol TFS System)     with measurements of the volume of blood in the body.   "
210231|NCT00603226|"     To compare patients with Slow Coronary Artery Flow to patients with normal flow and to     determine whether there is a difference in their future incidence of heart disease.   "
210232|NCT00603239|"     This study will assess safety and efficacy of exenatide in combination with a     thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2     diabetes who have not achieved adequate glycemic control.   "
210233|NCT00603252|"     This protocol posting describes the booster phase of the study. The objectives & outcome     measures of the primary phase are presented in a separate protocol posting (NCT number =     NCT00289731).   "
210234|NCT00603265|"     The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving the pain     associated with diabetic peripheral neuropathy (DPN) compared with placebo and duloxetine (a     marketed drug approved for the treatment of painful DPN). The pain symptoms of DPN are     thought to be due to damage to nerves caused by the diabetes.   "
210235|NCT00603278|"     This study is designed to determine if the investigational drug is effective and safe in     individuals with asthma.   "
210236|NCT00603291|"     The purpose of this study is to assess the weight loss effect of lorcaserin during and at the     end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus     treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral     hypoglycemic agents.   "
210237|NCT00603304|"     The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the     CAMUS trial will be given one out of two possible treatments at random. One out of every two     men would get an inactive placebo treatment. One out of every two men would get Saw palmetto     pills.      This kind of scientific study is the best way to find out if the plant extracts really work     to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study,     men will not know which of the two treatments they are assigned to. They will be followed     very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial     will be studied over 72 weeks. Tests and all medications needed as part of the study will be     provided at no charge to the participant. Participants will be responsible for all other     costs not associated with the study tests and medications. All information on study     participants will be held in the strictest confidence and no one would have access to patient     information other than the required authorized health care and research personnel.   "
210238|NCT00603317|"     Several case reports indicate that the use of the antibiotic combination amoxicillin and     clavulanic acid (AM-CLAVAC) can interact with warfarin pharmacodynamics. However, fever per     se might also be responsible of these warfarin overdose reports, as well as the use of high     dose paracetamol.      The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics     of warfarin among patients at steady state Double blinded cross over controlled study vs     placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3     and a stable INR and a stable dose.   "
210239|NCT00603330|"     The present project aims at investigating the role of MSC for the treatment of patients with      Part 1: Steroid-refractory grade II-IV acute GVHD.      Part 2: Poor graft function (PGF)      Part 3: Low or falling donor T-cell chimerism after allogeneic HCT.      This is a multicenter phase II study examining the feasibility and efficacy of this approach.   "
210240|NCT00603343|"     The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the     antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic     overactive bladder and urinary incontinence.   "
210241|NCT00603356|"     This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.   "
210242|NCT00603369|"     One subgroup of adolescents at particular risk for HIV is those with psychiatric disorders.     Furthermore, those with histories of sexual abuse have been found to have riskier attitudes,     poorer sexual communication skills, and less consistent condom use than non-abused peers.     This study implemented and evaluated interventions for adolescents in intensive psychiatric     treatment settings, particularly those with histories of sexual abuse. It is hypothesized     that those participating in the intervention that addresses affect management and cognitive     monitoring strategies will show fewer HIV-risk related behaviors and attitudes at posttest     than peers in an information-based intervention.   "
210243|NCT00603382|"     This study is designed to determine if the investigational drug is effective and safe in     individuals with asthma.   "
210245|NCT00603408|"     The purpose of this study is to determine whether Cisplatin when given with radiation therapy     prior to surgery is effective in improving response to treatment in breast cancer patients.     Tumor, blood and bone marrow samples will be collected in this study and will also help     researchers determine if cisplatin is able to change tumor DNA so it cannot multiply itself     and create more tumor cells, and cause the tumor cells to die.   "
210246|NCT00603421|"     This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line     on the rate of suicide attempts and self-injurious behaviors in borderline patients.   "
210247|NCT00603434|"     This is a human inpatient clinical pharmacology study to assess potential interactions     between intravenous (i.v.) methamphetamine infusion and oral osmotic release methylphenidate     (OROS-MPH). The primary objective of this study is to determine the safety of the OROS-MPH     concurrent with i.v. d-methamphetamine infusions of 15 mg and 30 mg. Safety outcome measures     include cardiovascular responses [heart rate (HR), blood pressure (BP), and     electrocardiograph (ECG) measurements], oral temperature, adverse events (AEs), and clinical     laboratory analyses.   "
210248|NCT00603447|"     To evaluate the safety and maximum tolerated dose (MTD) of carfilzomib in combination with     lenalidomide and dexamethasone in patients with relapsed multiple myeloma   "
210259|NCT00603590|"     Cardiovascular is a major cause of mortality in Iran, accounting for 45.7% of deaths. In     Golestan (North Eastern Iran) preliminary findings from follow-up of the Golestan Cohort are     consistent with national figures: with 45% (at least 22 of 48 deaths) of all deaths     attributed to cardiovascular events. Cardiovascular diseases will become an increasing     problem as the Iranian population ages.      In 2003 Law and Wald proposed prevention of cardiovascular disease using fixed-dose     combination therapy combining antihypertensive, lipid lowering and antiplatelet drugs in a     single preparation. They proposed that this treatment should be offered to all persons at     high risk of cardiovascular disease whether or not they have elevated blood pressure or     elevated serum lipid concentrations.      This pilot study aims to investigate the safety and efficacy of fixed-dose combination     therapy with two antihypertensive drugs, aspirin and atorvastatin in a population who would     not currently be considered eligible for antihypertensive treatment or for lipid lowering     treatment.      Methods:      This is a double-blind randomized controlled trial. The intervention group will be assigned     to take a tablet consisting of a single daily tablet comprising Aspirin 81mg,     Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg. The control group will be     assigned to an identical placebo.      The population studied includes men aged 50 to 80 (inclusive) and women aged 55 to 80     (inclusive) who are currently not eligible for or taking antihypertensive or lipid lowering     therapy. Persons who are found at baseline to have blood pressure >160/100 mm Hg, total     cholesterol >240mg/dL, existing cardiovascular disease or to be taking antihypertensive ore     lipid lowering therapy are excluded.      It is intended to randomize and follow up 500 subjects for 12 months. The primary outcome for     the purpose of sample size calculation is change in systolic blood pressure. Additional     outcomes include change in diastolic blood pressure, change in LDL cholesterol and occurrence     of adverse events.   "
210532|NCT00605553|"     This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as     measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a     function test is administered.   "
210249|NCT00603460|"     Subjects with recurrent epithelial ovarian carcinoma or primary peritoneal cancer, who have     previously undergone vaccination in clinical study UPCC-11807 with DCVax-L, an autologous     vaccine with DC loaded in vitro with autologous tumor lysate.      Phase I Subjects enrolled in this study will receive leukapheresis; followed by     cyclophosphamide/fludarabine-induced lymphodepletion; followed by adoptive transfer of ex     vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells; followed by a     single DCVax-L vaccination, to establish feasibility and safety of this approach.      Primary Objectives of Phase I      To determine the feasibility and safety of administering vaccine-primed, ex vivo     CD3/CD28-costimulated autologous peripheral blood T cells in combination with DCVax-L     vaccination, following lymphodepletion with high dose cyclophosphamide/fludarabine.      Phase II      Twenty-two additional subjects will be randomized to receive either:        -  ARM-IIA: maintenance DCVax-L vaccination, in combination with oral metronomic          cyclophosphamide, or        -  ARM-IIB: leukapheresis, followed by cyclophosphamide/fludarabine-induced          lymphodepletion, followed by adoptive transfer of ex vivo CD3/CD28-costimulated          vaccine-primed peripheral blood autologous T cells, followed by maintenance DCVax-L          vaccination, plus oral metronomic cyclophosphamide.      Primary Objective of Phase II      To assess the distribution of progression-free survival at 6 months for patients treated with     maintenance DCVax-L vaccination plus oral metronomic cyclophosphamide as well as patients     treated with ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells     after lymphodepletion with high dose cyclophosphamide / fludarabine, followed by DCVax-L     boost vaccination and metronomic oral cyclophosphamide.   "
210250|NCT00603473|"     Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in     Japanese pediatric patients with partial seizures   "
210251|NCT00603486|"     The accuracy and/or performance of the GE DINAMAP noninvasive blood pressure (NIBP) monitors     may be improved with modifications in software and/or hardware monitoring techniques and/or     accessories. When changes are being made to the GE Monitor, testing can be done to evaluate     performance of the investigational devices during and/or after product development.   "
210252|NCT00603499|"     Objective : to test the BP lowering-effect of oral magnesium supplementation, as magnesium     chloride (MgCl2) solution, 2.5 g daily, in uncomplicated hypertensive type 2 diabetic     subjects with decreased serum magnesium levels Design : Randomised double blind placebo     controlled trial. Setting : Outpatients with type 2 diabetes from Durango, city in northern     Mexico Subjects : 82 subjects between 40 and 75 years of age with type 2 diabetes serum     magnesium deficiency and uncomplicated hypertension.      Interventions : During 4 months the intervention group received 2.5 gr of magnesium chloride     (50 ml of a solution containing 50 gr of MgCl2 by 1000 ml of solution ). Controls received     inert placebo.      Main outcome measure: Change in blood pressure. Increase of serum magnesium Secondary     outcomes measures: Changes in lipid profile   "
210253|NCT00603512|"     The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4     dose regimens of CP-690,550, combined with methotrexate, for the treatment with active     rheumatoid arthritis.   "
210254|NCT00603525|"     This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a     duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the     study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and     symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.   "
210255|NCT00603538|"     Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination     with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer   "
210256|NCT00603551|"     The hypothesis is that postmenopausal women who have received chemotherapy have a greater     bone loss than the same age controls. The aim of this study is to obtain baseline bone     mineral density (BMD) data on women with breast and gynecological cancers who have received     chemotherapy. By comparing the Z scores of postmenopausal women who have received     chemotherapy with age matched controls this hypothesis can be evaluated. Another goal of the     study is to compare the T-score of a Heel Bone Density Scan to the T-score of the DXA Scan to     see if there is a good correlation between peripheral and DXA scores.   "
210257|NCT00603564|"     The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2     administration by a Venturi mask in terms of gas exchanges improvement in patients with acute     respiratory failure due to community-acquired pneumonia.   "
210272|NCT00603759|"     chemotherapy- and radiotherapy-induced oral mucositis represents a therapeutic challenge     frequently encountered in cancer patients.This side effect causes significant morbidity and     may delay or interrupt the treatment plan, as well reduce therapeutic index. cyclo-oxygenase     2 (COX-2) is an inducible enzyme primarily expressed in inflamed tissues and tumor. COX-2     inhibitors have shown promise as radio- and chemosensitizer and reduce radio-induced     toxicities.      we have conducted a phase III, randomized double blind clinical trial to evaluate the     toxicity and efficacy of celecoxib, a selective COX-2 inhibitor, administered concurrently     with chemotherapy, and radiation for locally advanced head and neck cancer.   "
210258|NCT00603577|"     Primary objective:      To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate     of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following     randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon     cancer.      Secondary objective:        -  To assess the effect of xaliproden on patient-reported outcomes using the Functional          Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG          NTX-12 subscale).        -  To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2          PSN at 6 months        -  To assess the effects of xaliproden on the time to complete recovery from PSN        -  To evaluate the safety profile of xaliproden   "
210260|NCT00603603|"     Previous studies have demonstrated that patients who undergo surgery while they under general     anesthesia have fewer wound infections if they receive higher concentrations of oxygen but     this has never been studied in women who are undergoing cesarean section. We plan to     randomize women who are undergoing cesarean to receive either standard of care oxygen flow     through a nasal cannula during their cesarean section only or a higher concentration of     oxygen than they would typically receive through a face mask. Women will receive this therapy     during their cesarean and for 2 hours afterwards. We will follow them after their surgery for     evidence of infection either in their wound or their uterus.   "
210261|NCT00603616|"     Antibiotics have been used to treat Crohn's disease symptoms with the best studied     antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is     FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is     very poorly absorbed and over 97% of the drug taken orally is excreted in the feces.      The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for     the treatment of moderate to severe symptoms of Crohn's Disease.   "
210262|NCT00603629|"     The purpose of this study is to investigate mechanisms which cause acute asthma exacerbations     by examining blood and airway secretions during an acute onset (sputum or tracheal     aspirates). This pilot study is intended to uncover new mechanisms of asthma exacerbation and     to generate hypotheses for future study. By collaborating with Genentech, we (scientists at     UCSF) plan to incorporate the latest scientific findings into our work to discover and     develop new treatments for asthma.   "
210263|NCT00603642|"     The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with     placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic     purpura (ITP) .   "
210264|NCT00603655|"     The aim of this study is to compare the effects of diets with different glycemic load (GL) on     body composition and biochemical markers in overweight and obese subjects during a 12-month     period.   "
210265|NCT00603668|"     This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.   "
210266|NCT00603681|"     The aim of the study is to show that new polyethylene glycol (PEG) solution without     electrolytes is as effective in the treatment of constipation as PEG solution with     electrolytes in the elderly institutionalized people. Also, the tolerability and the safety     of the study drug will be examined.   "
210267|NCT00603694|"     Neurocognitive impairment as a result of gamma knife radiosurgery has not been well studied     and is poorly understood. Radiosurgery to the base of skull for the treatment of benign and     malignant disorders may consequently impair memory function. There is a need to evaluate     changes in memory function that may be associated with such exposures.      In this pilot study, we will investigate changes in hippocampal-dependent memory function in     10 patients receiving a low SRS dose to the hippocampus. We will also investigate such     changes in a no-dose control group and a high-dose control group. This study will provide     preliminary estimates of variance in memory changes associated with radiation exposure, and     will then permit us to design future studies with the appropriate sample size justification.   "
210268|NCT00603707|"     Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and     SmartPill) are equivalent and is demonstrated if the study population shows a correlation of     0.7 or higher.   "
210269|NCT00603720|"     The purpose of this study is to determine, with Positron Emission Tomography (PET), the role     of nitric oxide in the age-associated effect on fatty acid and glucose delivery on myocardial     substrate metabolism.   "
210270|NCT00603733|"     The purpose of this study is to demonstrate that the new modified oral extended-release     Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg     tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of     quiescent disease.   "
210271|NCT00603746|"     This study is designed to determine if the investigational drug is effective and safe in     individuals with asthma.   "
210273|NCT00589823|"     Cancer patients taking regular medication for their pain often still have episodes of severe     pain that 'break through' despite their background pain treatment. Fentanyl is a strong,     short-acting painkiller often used to treat this 'breakthrough' pain. Nasalfent contains     fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal     spray. This study will test the efficacy and safety of Nasalfent compared to Immediate     Release Morphine Sulphate in the treatment of breakthrough cancer pain.   "
210274|NCT00589836|"     The purpose of this study is to learn about the twisting or wringing motion of the heartbeat     called torsion which can be seen on ultrasound. This study will help figure out if there is a     difference in the how a heart twists at rest and with exercise in people with normal hearts     compared to people with HCM (abnormally thickened heart muscle). Volunteers will have an     echocardiogram (ultrasound of the heart) while lying on a bed both at rest and while peddling     a wheel located at at the foot of the bed. The patients will take about 1 to 1 1/2 hours     total and the study will be complete after this procedure.   "
210275|NCT00589849|"     T-wave alternans is an electrocardiographic finding that has been shown to predict the     occurrence of future cardiac arrhythmias in patients who have had a heart attack. What is     unknown about T-wave alternans testing is when is the best time to perform the test. In most     studies, T-wave alternans testing is conducted 4 weeks or more after a heart attack. It is     unknown if T-wave alternans testing performed prior to hospital discharge in heart attack     patients is reliable. The objective of this project is to determine the diagnostic accuracy     of T-wave alternans testing performed prior to hospital discharge and again at 30 days after     hospital discharge in patients who have suffered a heart attack.   "
210276|NCT00589862|"     It is recommended that patients who have drug-eluting stents placed in their coronary     arteries take aspirin and Plavix (Clopidogrel) for at least a year. Patients who stop taking     these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs     are at a higher risk of clots occurring inside the stents which may result in a heart attack.     At the present time, it is unknown if increasing the doses of the antiplatelet agents is     effective in overcoming this resistance. The purpose of this project is to identify patients     with antiplatelet drug resistance and to test whether an increase in the Plavix (Clopidogrel)     dose overcomes antiplatelet drug resistance.   "
210277|NCT00589875|"     The purpose of this study was to evaluate the safety and potential efficacy of Gene Mediated     Cytotoxic Immunotherapy for malignant gliomas. The approach used an adenoviral vector     (disabled virus) engineered to express the Herpes thymidine kinase gene (aglatimagene     besadenovec, AdV-tk), followed by an antiherpetic prodrug, valacyclovir. The AdV-tk vector     was injected into the resection bed after standard tumor surgery and valacyclovir pills were     taken for 14 days. Standard radiation and chemotherapy were administered which have been     shown to work cooperatively with AdV-tk + prodrug to kill tumor cells. The hypothesis is that     this combination therapy can be safely delivered and will lead to improvement in the clinical     outcome for patients with newly diagnosed malignant gliomas, including glioblastoma     multiforme (WHO grade IV) and anaplastic astrocytomas (WHO grade III).   "
210278|NCT00589888|"     Insulin resistance has been implicated as the central mechanism in the development of several     cardiovascular risk factors including hypertension, diabetes, lipid disorders, and     coagulation disorders. Recent evidence suggests that increased levels of a circulation fat     (free fatty acids or FFAs) are a leading candidate causing insulin resistance. Our     preliminary studies in indicate that, in addition to insulin resistance, the infusion of     Intralipid and heparin to increase FFAs resulted in a significant rise in systolic and     diastolic blood pressure, impaired endothelial (vascular) function, and increased     inflammatory markers in obese African Americans with and without diabetes. The effects of FFA     on insulin action are well established; however, the blood pressure and vascular effects of     FFAs infusion in obese subjects have not been fully investigated. We hypothesize that     observed changes in blood pressure are the result of acute endothelial dysfunction, and/or     increased activation of the autonomic nervous system. No previous studies have attempted to     determine a dose response effect of increasing FFA on blood pressure. In addition, it is not     know if increased FFAs by repeated oral fat load results in similar blood pressure than     intravenous lipid infusion. Accordingly, we propose: 1) a systematic evaluation of the     effects of increasing FFA levels on blood pressure and endothelial (vascular) function, and     2) determine the effects of comparable increases in FFA concentration via intravenous     infusion of Intralipid or by repeated oral fat load on blood pressure, insulin resistance and     endothelial dysfunction in obese subjects.      A group of 10 obese normotensive subjects will be admitted to the Grady Clinical Research     Center or to the Outpatient Research Unit in the Grady Diabetes Clinic on five occasions. In     four of these admissions, research subjects will receive an 8-hour intravenous infusion, in     random order, of increasing Intralipid concentration (10 ml, 20 ml, 40 ml per hour) or normal     saline (40 ml per hour). During the final admission, research subjects will receive an oral     liquid fat diet every 2 hours for 8-hours. The effect of increased FFAs on blood pressure and     endothelial (vascular) function via intravenous infusion and via oral fat load therapy will     be assessed.   "
210279|NCT00589901|"     The primary objective of this study is to evaluate the time to progression. Secondary     objectives are safety, OS and pharmacogenetic analysis. Sixty patients will be enrolled into     this study.   "
210280|NCT00589914|"     The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in     patients with Schizophrenia.   "
210281|NCT00589927|"     To evaluate whether the cilostazol reduce neointimal hyperplasia after ZES     (Zotarolimus-eluting stents) implantation, the investigators performed     double-blind,randomized, multicenter, prospective study compared triple antiplatelet therapy     (aspirin plus clopidogrel plus cilostazol) and dual antiplatelet therapy (aspirin plus     clopidogrel) for 8 months in patients with long coronary lesion treated with ZES.   "
210282|NCT00589953|"     The highest risk for perinatal brain injury occurs among extremely premature infants who     weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible,     associated with neurodevelopmental disability, and without adequate treatment modalities.     Research in recent years suggest in both animal and human studies that erythropoietin (Epo)     may have significant neuroprotective effects. Given the historical safe medical profile of     Epo when used for anemia of prematurity but the likely need for a greater dosage regimen for     activation of neuroprotective pathways against neonatal brain injury, we therefore propose     this phase II study of high-dose Epo in very low birth weight infants for the prevention     and/or attenuation of prematurity-related cerebral hemorrhagic-ischemic injury.   "
210283|NCT00589966|"     This study will test the effectiveness of an 8-week group intervention for African American     men who have been treated for prostate cancer. The group intervention is based on 1) the     cognitive-behavioral theoretical approach to improving adjustment to cancer and 2)     masculinity theory as it relates to coping strengths and preferences in men. We will test the     effectiveness of this coping skills intervention for improving survivors' quality of life in     4 areas: 1) distress related to sexual, urinary, and bowel symptoms; 2) self-confidence for     managing symptoms; 3) overall emotional functioning; and 4) overall physical functioning. The     effect of the coping skills group intervention in these 4 areas will be compared to a     comparison intervention in which African American men will receive basic education about     prostate cancer, but will not participate in coping skills training.   "
210284|NCT00589979|"     Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from     their current analgesic regimen will participate in a pilot clinical trial to evaluate the     effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee     pain from OA.   "
210285|NCT00589992|"     To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide     will be administered intravenously in patients undergoing an Afib ablation. The hypothesis of     this study is that ibutilide will decrease the high frequency signals observed in Afib     suggesting the presence of micro reentrant circuits as the basic mechanism of Afib,     especially for the paroxysmal Afib group. The potential difference in response to the     ibutilide in patients with paroxysmal versus persistent Afib may show the difference in the     underlying mechanism of Afib between these two groups.   "
210286|NCT00590005|"     Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there     is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the     airways   "
210287|NCT00590018|"     Babies having heart surgery often have problems after surgery with their blood pressure and     getting enough blood to their bodies. To treat this they require medicines to keep their     blood pressure high enough to get blood to their bodies. The side effects of these medicines     include fast heart rates and increasing the amount of work the heart has to do.     Corticosteroids are made by the body and help to use the energy in the food people eat,     control the chemicals in their blood and maintain their blood pressure. Corticosteroids made     by the body may be decreased in patients that have major surgery. Corticosteroids help to     increase blood pressure and can decrease the amount of blood pressure medicines a patient     requires. Corticosteroids have been shown to increase blood pressure in patients with     bacterial infections and in very small, premature babies but have only been studied in a few     babies who have had heart surgery. The way corticosteroids work is unknown but may involve     decreasing the body's response to being on a heart-lung machine or give steroids not being     made by the patient.      Corticosteroids have been shown to be helpful in treating many diseases. The purpose of this     study is to look at the effects of corticosteroids in babies who have had heart surgery and     need blood pressure medicines in the intensive care unit after surgery. Our idea is that     getting corticosteroids will allow us to decrease the amount of blood pressure medicines each     patient needs and improve how they do after surgery. We also plan to do blood tests to help     determine how the corticosteroids are working.      It will be randomly determined if the subject receives corticosteroids or salt water. The     subject will receive a corticosteroid or salt water once a day for five days. Their vital     signs will be monitored, especially blood pressure and their need for medicines to increase     their blood pressure. Blood work will also be obtained to determine their body's ability to     make steroids.   "
210288|NCT00590031|"     Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive     six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4     and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy     with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of     radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of     chemoradiotherapy.   "
210298|NCT00590174|"     The purpose of ZEST-LATE (Evaluation of the Long-term Safety After Zotarolimus-Eluting Stent,     Sirolimus-Eluting Stent, or PacliTaxel-Eluting Stent Implantation for Coronary Lesions - Late     Coronary Arterial Thrombotic Events) trial is to assess the relationship between long-term     clopidogrel use beyond 1 year and long-term rates of death or MI after DES implantation and     to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic     events.   "
211154|NCT00618748|"     To assess the efficacy and safety of olanzapine in the long-term treatment for patients with     bipolar I disorder, depressed.   "
210289|NCT00590044|"     Diabetic ketoacidosis (DKA) is the most serious emergency in patients with diabetes. With an     estimated 100,000 admissions per year in the United States, DKA is also the leading cause of     death in children with type 1 diabetes, and accounts for a significant proportion of     admissions in adult patients with type 1 and type 2 diabetes. The mainstay in the treatment     of DKA involves the continuous intravenous (IV) infusion of regular insulin or the frequent     subcutaneous (SC) injections of regular or rapid-acting insulin analogs. Multiple studies     have reported successful protocols for insulin administration during the acute management of     DKA, but they have failed to address the transition phase from IV to SC maintenance insulin     regimen. The American Diabetes Association (ADA) position statement recommends the use of     split-mixed insulin combination of regular and intermediate-acting insulin (NPH). This     regimen, however, are associated with a high rate of hyperglycemia shortly after     discontinuation of IV insulin and a risk of hypoglycemia during the hospital stay. Recently,     the long-acting basal insulin glargine (Lantus®, Sanofi Aventis Pharmaceuticals) has been     shown to facilitate glycemic control with lower rate of hypoglycemic events than     intermediate-acting insulin in subjects with type 1 and type 2 diabetes. This study aims i)     to determine the effects of giving a dose of glargine insulin shortly after starting an     intravenous insulin infusion on glycemic control, time to resolve DKA, and rate of     hypoglycemia in patients with DKA, and ii) to compare the safety and efficacy of basal/bolus     (glargine/glulisine) insulin versus the standard split-mixed insulin regimen of NPH and     regular insulin after the resolution of DKA. The hypothesis is that basal (lantus®) insulin     as compared to NPH insulin shortly after the start of insulin infusion will improve inpatient     glycemic control in patients with DKA.      This investigator initiated research will be conducted at Grady Memorial Hospital, Atlanta     and at University of Minnesota, MN. Dr Umpierrez designed the study and will serve as     principal investigator. A total of 40 patients will be recruited at each site.   "
210290|NCT00590070|"     The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in     acute myocardial infarction is described in up to 40% of cases. This event is associated with     a worse prognosis at follow up and an unfavourable left ventricular remodelling . Two main     pathogenetic mechanisms cause no-reflow: distal embolization and ischemia-reperfusion injury.      Due to the multifactorial pathogenesis of no-reflow during acute MI a combined mechanic and     pharmacologic approach is believed to offer a better solution for achieving optimal     microvascular reperfusion. Thus, in this randomized study we will assess the effect of     nitroprusside or adenosine in adjunct to current best therapy (thrombus aspiration and     IIb-IIIa antagonists) for ST elevation MI using ST segment resolution on standard 12 leads     ECG as primary endpoint of myocardial reperfusion.   "
210291|NCT00590083|"     The main purpose of this study is to see if these T-lymphocytes are safe. To make these     Ad-specific T lymphocytes the investigators will obtain blood from the stem cell donor and     transfer Ad into another type of blood cell, called monocytes. These cells can then stimulate     the T lymphocytes and train them to kill cells infected with Ad. The investigators will then     grow these Ad-specific T lymphocytes by more stimulation with Ad-infected monocytes and a     third type of blood cell called a B lymphoblast from the donor. After testing the T     -lymphocytes, the investigators will inject them into patients after transplant who are at     high risk of serious Ad virus infection. The investigators will make sure the injected cells     are safe and see if they affect the growth and behavior of adenoviruses in the patient's own     body.   "
210292|NCT00590096|"     I-123-MIBG is used to image patients with neuroblastoma, pheochromocytoma and other neural     crest tumors   "
210293|NCT00590109|"     The purpose of this project is to further characterize inherited predisposition to breast     cancer mediated by specific BRCA alleles (BRACA1 185delAG and 5382insC; BRCA2 6174delT) among     Jewish women.   "
210294|NCT00590122|"     To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth,     works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.   "
210295|NCT00590135|"     The purpose of this study is to find out if an approved medicine that is used to lower     cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve     in patients with a condition called aortic stenosis. Patients who have aortic stenosis who     volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a     physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of     the heart) at the start of the study and every 6 months, stopping at 2 years.   "
210318|NCT00590434|"     The aim of the study is to study the risk of colorectal cancer and polyps in people older     than 80 years compared to the younger age group. The researchers hypothesized that     colonoscopy in older people is likely to have more complications without detection of a     significant number of large polyps and cancer.   "
210908|NCT00613405|"     The purpose of this study is to explore the interaction between stress and marijuana cues, in     hopes that it may lead to the development of new treatments for marijuana dependence.   "
210296|NCT00590148|"     The purpose of this study is to evaluate the FIM™ as a measure of daily function in children     with sickle cell disease hospitalized with vasoocclusive pain. Currently, the standard for     pain assessment is a rating of pain intensity, as determined by observation (for younger     children) or self-report (for older children and adolescents). However, these measures of     pain intensity are not effective in recurrent or chronic pain states, and in sickle cell     disease in particular. Pediatric patients who are hospitalized with vasoocclusive pain often     do not report a decrease in pain intensity; however, other indications of clinical status,     such as ambulation, less use of opiates from the patient-controlled analgesia (PCA) pump,     increased food intake, and transition to oral pain medication, signify that the patient may     be improving. As a result of our inability to get an accurate picture of the patients'     condition, we would like to have a summary of improvement that would reflect these changes in     clinical status and reflect the reduced impact of sickle cell pain on the patient's life. In     this study, we plan to evaluate a standardized functional assessment measure in pediatric     patients with sickle cell disease. It is hypothesized that FIM™ scores will correlate with     other indicators of clinical status, such as movement, quality of sleep, use of IV opiates     from the patient-controlled analgesia (PCA) pump, and use of intravenous vs. oral pain     medications. It is also hypothesized that the FIM™ will demonstrate adequate responsiveness     to change in functional status within a 3-7 day hospitalization by a progressive increase in     scores and associations with other indicators of clinical improvement.   "
210297|NCT00590161|"     One third of the population in the United States has nonalcoholic fatty liver disease     (NAFLD). Nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to     cirrhosis.Currently, there is no proven therapy for patients with NASH. The investigators     core hypothesis is that therapy of patients with NASH with pentoxifylline (PTX) for one year     will result in improvement of biochemical parameters of liver disease and hepatic histology.     The focus of this proposal is on the effectiveness of pentoxifylline (PTX) in improving     laboratory and tissue parameters of liver disease, parameters of insulin-resistance, and     levels of cytokines in patients with NASH.   "
210300|NCT00590200|"     This proposal delineates a research plan to collect blood from the patients undergoing heart     catheterization or have had a heart catheterization within one year, coming in for outpatient     appointments, or have scheduled cardiac CT scans at the Cleveland Clinic over a five-year     period for the purpose of establishing a gene bank registry. The University of North Carolina     at Chapel Hill will enroll 1,000 non-Caucasian patients. MetroHealth Medical center in     Cleveland will enroll 1,000 non-Caucasian patients. The blood collected will be processed to     create a repository of DNA, lymphoblastoid cell line immortalization on selected patient     populations, plasma and serum. The DNA will be amplified in certain patient populations to     preserve the quantity. Along with a sample of blood collected from individual patients, a     concise general medical history, demographic data, electrocardiographic data,     echocardiographic data (available for about 55% of patients at the present time), and     laboratory data will be collected. A short interview will take place after enrollment during     the outpatient visit or hospital stay, or may be conducted via phone call after enrollment.     All the clinical data gathered will be compiled in GATC heart center database, and would be     stored in a format where a culmination of clinical findings, i.e. representing a disease of     interest, can be used to search the database to identify the blood samples of all patients     with such characteristics for further study.   "
210301|NCT00590213|"     The primary objective of this trial is to examine the value of prophylactic versus     therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast     pain. Patients will receive either prophylactic radiotherapy to the breast at a dose of 12Gy     (as two fractions of 6 Gy in consecutives days), or will not receive any radiotherapy prior     to commencing CASODEX 150mg monotherapy.   "
210302|NCT00590226|"     High blood glucose levels in hospitalized patients with diabetes are associated with     increased risk of medical complications. Improved glucose control with insulin injections may     improve clinical outcome and prevent some of the hospital complications. It is not known;     however, what is the best insulin regimen in hospitalized patients. Recently, the use of     basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart,     glulisine) has been shown to facilitate outpatient glycemic control with lower rate of     hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will     determine the efficacy and safety of the combination of detemir and aspart insulin in the     inpatient management of subjects with diabetes. We hypothesize that in patients with type 2     diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus     insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic     events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a     long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a     rapid-acting insulin which is given subcutaneously several times a day and frequently before     meals. Detemir and aspart insulins are approved for use in the treatment of patients with     diabetes by the FDA.      This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta     and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and will     serve as principal investigator. A total of 65 patients will be recruited at Grady and 65     patients at the Rush University Medical Center, Chicago, IL.   "
210319|NCT00590447|"     This phase-II trial will investigate the efficacy, safety and the tolerability of a     sequential therapy consisting of 4 courses of single agent rituximab followed by 4 courses of     R-CHOP chemotherapy in patients with CD20+ posttransplant lymphoproliferative disorders     (PTLD). However, responders to rituximab achieving a CR after the first 4 applications of     rituximab will go on with rituximab monotherapy and will not receive chemotherapy.   "
210303|NCT00590239|"     -  The use of high resolution endoscopy (HRE), narrow band imaging (NBI) and          chromoendoscopy increases the detection rates of Barrett's esophagus (BE) and early          neoplasia.        -  Endoscopic mucosal resection (EMR) will improve the accuracy for detection of          dysplasia/early neoplasia.      Specific Aim 1 - To create a video-atlas of non-dysplastic and dysplastic/early neoplastic     lesions in patients with BE. This will be used for training purposes and to assess learning     curve associated with these new technologies.      Specific Aim 2 - To create a standardized classification system for the mucosal and vascular     patterns observed in patients with BE.      Specific Aim 3 - To determine the interobserver agreement using the video-atlas for the     mucosal and vascular patterns classification agreed upon.      Specific Aim 4 - To determine the endoscopic detection rate of esophageal cancer or     precancerous lesions removed during endoscopy.      Specific Aim 5 - To determine the pathologic and clinical outcomes of patients undergoing     EMR/ablation; including morbidity, mortality and complications of the procedure.      Results to date (June 2008) : this study is active and open to enrollment. Currently 26     patients have enrolled in this study at the Kansas City VA medical center. In order to     participate, patients must be eligible for care at the KCVA hospital.   "
210304|NCT00590252|"     To test and validate newly developed magnetic resonance (MR) pulse sequences for their     ability to enhance the collection of morphological, biomedical, and functional information     from the human body. To test clinical protocols on the various MR systems available at     Brigham and Women's Hospital (BWH).   "
210305|NCT00590265|"     The purpose of this study is to evaluate the efficacy and safety of light therapy for the     treatment of bipolar type II patients relapsing into a depressive phase during autumn or     winter.   "
210306|NCT00590278|"     The pilot study is designed to investigate the value of Neo-adjuvant Tomudez in combination     with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response     rate and increasing the resectability of initially inoperable rectal cancer.   "
210307|NCT00590291|"     The purpose of this study is to discover genes that may cause Coronary Artery Disease (CAD)     or Arteriovenous Malformation (AVM).   "
210308|NCT00590304|"     The purpose of the study is to evaluate asthma and examine the homes of children with asthma     living in rural areas of the state. This study is being done to give investigators more     information about the presence of allergens and endotoxin in the homes of children with     asthma living in the delta region of Arkansas.   "
210309|NCT00590317|"     This study will compare the effect of prochlorperazine and ondansetron for the treatment of     nausea and vomiting in the emergency department.   "
210580|NCT00606190|"     The purpose of this research study is to evaluate two standard approaches of supplying blood     and oxygen to your brain during open heart surgery.   "
210310|NCT00590330|"     The purpose of this study is to identify all the bacterial species present in the respiratory     tracts of patients with Cystic Fibrosis (CF), and to connect them with clinical information.     Traditional culture methods of throat swab and sputum samples can only identify the most     prevalent bacteria in samples, those of which there are over about 5 million bacteria per     teaspoon. A recently developed method has been found to be more sensitive and can detect up     to several hundred bacterial species in throat swab or sputum sample of individual CF     patients.   "
210311|NCT00590343|"     The purpose of this study is to examine if PTK787/ZK222584 (vatalanib) will stabilize or     decrease rising biochemical markers along with progressive disease or syndrome symptoms in     patients with metastatic neuroendocrine tumors.   "
210312|NCT00590356|"     This study was designed to evaluate the efficacy and safety of Starclose (Abbott Vascular     Devices) for femoral access site closure in patients undergoing PCI compared to Angio-Seal     STS Plus (St. Jude Medical).   "
210313|NCT00590369|"     Hypotheses: (1)Wound healing during hospital stay will be equal between systems, (2)RNs will     perceive the Versatile One (EZCare) system as easier to use, (3)Costs related to dressing     changes will be less with Versatile one (EZCare), (4)Hospital length of stay will be equal or     shorter with the Versatile One (EzCare) system, (5) Nursing time using Versatile One (EZCare)     will be less than or equal to VAC system, (6) Patients will report less pain during dressing     changes with Versatile One (EZCare).   "
210314|NCT00590382|"     Expanded access to the AMPLATZER Muscular VSD Occluder   "
210315|NCT00590395|"     This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission     tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a     direct method of detecting infection and/or inflammation of the gallbladder.   "
210316|NCT00590408|"     Statins are medications that lower blood cholesterol by inhibiting cholesterol production in     the liver. Overall, statins are well tolerated. Approximately 10% to 15% of patients report     muscle aches/pain while taking statins. In a very small percentage of patients (<0.01%; less     than one in 10,000 people), muscle aches/pains may be accompanied by more serious muscle     damage. In these patients, statins must be discontinued. In some reports, patients taking     statins have reduced blood levels of coenzyme Q10. Coenzyme Q10 is an essential protein which     is present in all human cells needed for normal cell function. Coenzyme Q10 has been tested     in patients with heart failure where it has been shown to be safe and effective. Many     patients with heart conditions take coenzyme Q10, but the risks and benefits of     supplementation with this product is unknown. Coenzyme Q10 is considered a dietary supplement     and is not approved by the Food and Drug Administration (FDA) for any medical condition.     Coenzyme Q10 has very few, if any, side effects. Upset stomach (gastritis), headache, body     ache, and low blood pressure have been reported. The objectives of this project are to test     the efficacy and safety of coenzyme Q10 in treating muscle aches/pain in patients already     taking statins who develop these symptoms.   "
210317|NCT00590421|"     Background: During the first half of the 20th century, scalp irradiation was a standard     treatment for induction of epilation in children suffering from Tinea Capitis. These children     are now more than 50 years old and the aim was to investigate the possible association     between their childhood low dose irradiation exposure and development of carotid     atherosclerotic disease in adulthood.      Methods: The study included 145 individuals treated by irradiation in their childhood, and     150 matched control subjects with no history of irradiation. B-mode ultrasound imaging and US     Doppler were used to measure carotid and femoral stenosis and Intima-Media Thickness (IMT).     Blood samples were taken for lipid profile and homocysteine evaluation.   "
212191|NCT00630422|"     The purpose of this study is to evaluate and determinate the functional abilities in Rett     syndrome conforming to the established Pediatric Evaluation of Disability Inventory (PEDI).   "
210320|NCT00590460|"     The purpose of this study is to discover whether children and adults with Fanconi anemia (FA)     can be safely and effectively transplanted with Human Leukocyte Antigen (HLA) mismatched (up     to one haplotype), HLA-matched sibling, or unrelated donor stem cells, when leukocytolytic     monoclonal antibodies are the sole conditioning agents (patients receiving an HLA mismatched     transplant will receive Fludarabine as part of the conditioning regimen). Three monoclonal     antibodies (MAb) will be used in combination. Two of them, YTH 24 and YTH 54 are rat     antibodies directed against two contiguous epitopes on the CD45 (common leucocyte) antigen.     They have been safely administered as part of the conditioning regimen for 12 patients     receiving allografts (HLA matched and mismatched) at this center. They produce a transient     depletion of >90% circulating leucocytes. The third MAb is Campath 1H, a humanized rat     anti-CD52 MAb. This MAb has been widely used to treat B cell chronic lymphocytic leukemia     (B-CLL) and more recently has been safely given at this and other centers as part of a     sub-ablative conditioning regimen to patients with malignant disease. Because these MAb     produce both profound immunosuppression and significant, though transient, myelodestruction     we believe they may be useful as the sole conditioning regimen in patients with Fanconi     anemia, in whom the use of conventional chemotherapeutic agents for conditioning produces a     high rate of short and long term toxicity. We anticipate MAb mediated subablative     conditioning will permit engraftment in a high percentage of these patients with little or no     immediate or long term toxicity. Campath IH persists in vivo for several days after     administration and so will be present over the transplant period to deplete donor T cells as     partial graft versus host disease (GvHD) prophylaxis. Additional GvHD prophylaxis will be     provided by administration of the medication FK506.   "
210321|NCT00590473|"     The hypothesis for this study is that bilateral sacral neuromodulation will improve symptoms     of interstitial cystitis by at least 25% when compared to unilateral sacral neuromodulation     as reported by patient's responses to the Interstitial Cystitis Symptom and Problem Indices.      This study will be a prospective randomized study comparing bilateral to unilateral sacral     neuromodulation. The study population will include all patients diagnosed with interstitial     cystitis, using the NIDDK criteria, having staged sacral neuromodulator stimulators placed at     Hahnemann University Hospital.   "
210322|NCT00590499|"     Agitation is a significant clinical issue in anesthesiology and critical care medicine.     Several studies have carried out to survey the epidemics of agitation in post-anesthesia care     unit and intensive care unit, and results revealed that agitation had an adverse impact on     outcomes. To our clinical experience, agitation can occur in postoperative neurosurgical     patients, and is often difficult to manage. However, agitation in this subset of patients is     poorly evaluated. In present study, adult patients following craniotomy will be enrolled     consecutively, and incidence, risk factor and outcome of emergent agitation will be     investigated. The results of the study will provide basic data for prevention and treatment     of agitation in postoperative neurosurgical patients.   "
210323|NCT00590512|"     The purpose of this study is to look at the effects of high- and low-salt diets on blood     vessel function in healthy subjects.   "
210324|NCT00590525|"     The laboratory test, C-Reactive Protein (CRP), has become well established as a marker of     inflammation. Recently a high CRP level (indicating an increase in inflammation) was     identified as a risk factor for atrial fibrillation. We are conducting this study with     patients such as yourself with atrial fibrillation who are planning to undergo cardioversion     to determine what sort of relationship exists between CRP levels and atrial fibrillation. We     will then look at success rates of converting atrial fibrillation to normal sinus rhythm,     compared to patients' CRP levels.   "
210325|NCT00590538|"     The purpose of this research study is to test a new combination of medicines, Phenylbutyrate     and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most     common genetic mutation found in patients with CF is called Delta F508. Due to this mutation,     there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines,     pancreas and sweat glands. This lack of movement causes the clinical manifestations of the     disease.      Although Phenylbutyrate has been extensively used to treat patients with rare metabolic     diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein     is a naturally occurring substance that is found in food products such as soy and tofu, but     is also an investigational drug for this study. When used together, both drugs may be able to     restore normal chloride and salt (water) movements in body organs and glands in people with     CF.      We will be studying salt and water movement in the nose by a technique called nasal     transepithelial potential difference (NPD).   "
210326|NCT00590551|"     There are many reasons that cause skin to breakdown. This study will only compare        -  pressure        -  pH        -  temperature      with the use of slings and without the use of slings (fabricated device used to safely handle     patient transfers and repositioning).      There will be no difference in skin pressure, pH, or temperature with or without the use of     slings.   "
210327|NCT00590564|"     Researchers want to see whether Sho-saiko-to (SST) can help in patients with chronic     hepatitis C. Chronic hepatitis C may cause swelling within the liver and this can lead to     scar tissue. In some patients, severe scarring of the liver, liver failure and liver cancer     can occur. Standard treatment for chronic hepatitis C is a drug called interferon with or     without another drug called ribavirin. There are a number of side effects that some patients     are unable to take. Other patients may have an initial response, but then the virus and the     inflammation come back.      Sho-saiko-to is an herbal medicine that has been used for many years in Asia to treat liver     disease. The purpose of the study is to evaluate whether Sho-saiko-to may improve liver     swelling and injury caused by chronic hepatitis C.   "
210328|NCT00590577|"     The primary objectives of this study are to evaluate the efficacy and safety of 3 fixed doses     of paliperidone palmitate administered i.m. after an initial loading dose of 150 mg eq. in     the deltoid muscle followed by either deltoid or gluteal injections for a total of 13 weeks     of treatment as compared with placebo in patients with schizophrenia.   "
210329|NCT00590590|"     This study will evaluate the efficacy and safety of two vaginal products compared with that     of placebo to determine if the two products are better than placebo in the relief of vaginal     discomfort.   "
210330|NCT00590603|"     This is a phase I dose escalation study to estimate the maximum tolerated dose (MTD) of the     novel combination of Arsenic, Ascorbic Acid and Velcade, followed by a phase II study     conducted using the MTD estimated from the phase I portion.   "
210342|NCT00596154|"     The purpose of this study is to determine the safety of this new treatment offered in this     study. PCNSL can be cured in less than half of patients with standard treatment, a     combination of chemotherapy and brain radiation. Also, the combination of chemotherapy and     brain radiation may result in serious lasting side effects. Most patients older than age 60     develop memory problems, difficulty walking or inability to control their bladder. Some     patients younger than age 60 also develop these side effects.   "
210331|NCT00590616|"     Aortic atheroma has been correlated with traditional cardiac risk factors, coronary, carotid,     renal and peripheral atherosclerosis, and is probably a manifestation of generalized     atherosclerosis. Aortic atheroma has also been shown to be associated with atrial     fibrillation, aortic valve sclerosis, and other calcification of the fibrous skeleton of the     heart. None of the previous studies have looked at the noninvasive prediction of aortic     atheroma using the history and physical signs of cardiovascular disease. This would be a time     and cost-effective bedside diagnostic tool that would be useful prior to cardiac surgery,     cardiac catheterization, and workup of ischemic stroke patients, especially when     transesophageal echocardiogram (TEE) is being considered for diagnosis but cannot be obtained     due to previously mentioned reasons. Although physical examination of peripheral vascular     disease is non-specific, a combination of physical examination signs increases the     probability of generalized atherosclerosis.   "
210332|NCT00590629|"     Several risk factors including high cholesterol contribute to heart disease. We know that     lowering triglycerides and raising HDL (protective cholesterol) in men reduces the risk for     heart disease. We expect that women will share this same benefit because the combination of     high triglycerides and low HDL appears to be a more important risk for heart disease in     women. Niacin reduces triglycerides and raises HDL. We also expect to see improvement in     markers of inflammation and clot formation and blood vessel health, which we hypothesize     should all confer a reduced risk of heart disease in women.      Women already taking lipid lowering statin will receive niacin therapy. We will measure blood     lipid levels, markers of inflammation and clotting as well as a non-invasive measure of blood     vessel reactivity. After 3 months of therapy we will repeat these measures.   "
210333|NCT00590642|"     This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive     Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large     percentage of patients fail to respond to medications and have residual symptoms. Such     patients are referred to as having treatment resistant OCD.   "
210334|NCT00590655|"     The aim of this study is to compare a weight reduction programme with and without a     maintenance programme in patients with severe obesity.   "
210456|NCT00604539|"     The purpose of this study is to determine the effect of a chondroitin sulphate conventional     treatment on the degree of severity of synovitis, as measured by magnetic resonance in     patients with knee OA with clinical synovitis.   "
210595|NCT00606385|"     Short-term outcomes of laparoscopic liver resection is better than those of open liver     resection      Laparoscopic liver resection is better than open resection in immunological aspects   "
210335|NCT00590668|"     Subjects eligible for this study have an irregular heartbeat called atrial fibrillation     (AF)and who are scheduled for a procedure that involves applying electrical energy in your     pulmonary veins, which is usually the site where this abnormal rhythm begins, or pulmonary     vein ablation      We will examine the size and function of the left atrium (one of the 4 chambers of your     heart) and the pulmonary veins before and after your ablation. This will be done by getting     extra measurements during tests you will be having done which are ICE (intra cardiac     echocardiography), TEE (transesophageal echocardiography) and CT scan (computed tomography),     and drawing some blood samples.      The purpose of getting these extra measurements and blood samples is:        1. to see whether TEE measurements done before your ablation can tell us if your atrial          fibrillation may come back after you ablation;        2. to see if TEE measurements look different before and after your ablation;        3. to see if a blood test can tell us if your atrial fibrillation may come back after your          ablation;        4. to look at how often pulmonary vein narrowing is found by TEE compared to how often it          is found by CT scan.      During the clinically indicated tests the doctor has ordered (TEE, ICE, CT scan), there will     be additional measurements taken as a part of this research. This means that the TEE exam     will last an additional 10-15 minutes, and the ICE procedure will last an additional 5-10     minutes. There is no additional time needed for the CT scan. In addition, we will be drawing     20 cc of blood (approximately four teaspoons).      The regularly scheduled follow up visit is usually three months after your ablation, we will     again be getting some extra measurements from the TEE and CT scan. This will add about 10-15     minutes to the TEE test, but no additional time will be needed for the CT scan. In addition,     we will be drawing 10 cc of blood drawn (approximately two teaspoons). A     ventilation-perfusion scan of the lungs will also be performed as part of standard clinical     care if significant PV stenosis is found by CT and/or TEE.   "
210336|NCT00590681|"     This study is being conducted to help determine whether the addition of Avastin (an     anti-cancer drug), when given along with temozolomide during the monthly cycles that follow     radiation, is able to delay tumor growth, shrink tumors, or impact how long people with GBM     live. This study is sponsored by Genentech, Inc., the manufacturer of Avastin.      Avastin is the experimental drug being administered in this research study. Avastin binds a     protein called vascular endothelial growth factor, or VEGF. VEGF is produced by tumors and     circulates in the blood. One of VEGF's main roles is to support the growth of new blood     vessels. During cancer, VEGF promotes the growth of blood vessels that bring nutrients to     tumor cells and help them grow. Avastin binds to VEGF, which then prevents VEGF from     functioning. In laboratory studies, Avastin prevented the growth of several different types     of cancer cells grown in animals. Avastin was approved by the Food and Drug Administration     (FDA) for the treatment of metastatic colorectal cancer in combination with chemotherapy.     Avastin has not been approved by the FDA for the treatment of GBM and is, therefore,     considered experimental. Avastin is currently undergoing testing (alone and in combination     with another anti-cancer drug, irinotecan) in persons with GBM that have come back after     conventional treatment.      Temozolomide (Temodar) is an anti-cancer drug that works by interfering with the growth of     cells (including cancer cells) by stopping their division. Temozolomide was approved by the     U.S. FDA for the treatment of newly diagnosed GBM in 2005.      Avastin and temozolomide are currently being used together in several research studies     involving people with newly diagnosed GBM. Limited information is available about either the     safety or effectiveness of this drug combination.   "
210337|NCT00590694|"     Patients with neovascular Age-related macular degeneration (AMD) and the particular feature     of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for     ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such     patients but only treated with ranibizumab until fluid within the layers of the retina was     absent, not until the entire PED was absent. This study hypothesizes that there may be a     difference in benefit between patients treated until just the retinal edema is gone and those     in which the retinal edema and PED are both gone.   "
210338|NCT00590707|"     This research is being done to see what effects sedative drugs during surgery have on     peoples' thinking processes after they wake up.   "
210339|NCT00596115|"     R(+) pramipexole dihydrochloride monohydrate [R(+)PPX], an experimental neuroprotective drug,     is provided in this open label extension study to ALS patients who have participated in     earlier clinical protocols.   "
210340|NCT00596128|"     Primary study endpoint: blood sugar values      Patients: Patients admitted to an ICU      5 steps:        1. Routine treatment,        2. Implementation of SOP for blood sugar monitoring and intervention,        3. Education of intensive care nurses,        4. 6 months free interval without further education or check-up of SOP implementation,        5. Check of SOP implementation and clinical outcome concerning range of blood sugar   "
210341|NCT00596141|"     The purpose of this pilot study is to determine if Topical Oral Wound Emulsion (TOWE) assists     with dental wound healing and relieves pain from oral wounds.   "
210343|NCT00596167|"     Short-daily hemodialysis is increasingly becoming a preferred alternative to the conventional     intermittent (three times per week) hemodialysis schedule. Studies have shown that     short-daily dialysis improves a patient's quality of life, high blood pressure, anemia and     calcium-phosphorus balance. Infection, however, will likely remain a persistent problem for     dialysis patients regardless of the frequency of treatments. There is currently a wealth of     information to guide doctors on how much and how frequently to give an antibiotic for     patients who receive intermittent (thrice weekly) hemodialysis. However, there is very little     information on how to prescribe antibiotics for patient's receiving short-daily hemodialysis.     This study will develop drug dose guidelines for patients receiving short-daily hemodialysis     for three frequently used antibiotics, vancomycin, levofloxacin and gentamicin. These     guidelines will assist doctors so that patients receive the most effective dose and frequency     of an antibiotic to treat their infection.      The following is the study hypothesis which will be tested with two-sided, one sample t-tests     comparing the AUC observed to historical measures8.      1) Vancomycin, levofloxacin and gentamicin are removed to a greater extent by short-daily     hemodialysis than intermittent hemodialysis.      The following are the specific aims:        1. Determine the interdialytic pharmacokinetics of vancomycin, gentamicin, and levofloxacin          by short-daily HD.        2. Determine the extent of vancomycin removal when administered during the last hour of          short-daily HD.        3. Develop drug-dosing guidelines for vancomycin, gentamicin and levofloxacin for patients          receiving short-daily HD.   "
210344|NCT00596180|"     That SPECT brain imaging tracks and is consistent with clinical history and physical exam as     well as cognitive testing.   "
210345|NCT00596193|"     Neuropeptide Y (NPY) potently inhibits pain neurons in rats, but does this occur in human     pain neurons? This hypothesis will be tested using microdialysis probes in patients who elect     to have root canal treatment or extraction of thier tooth.   "
210613|NCT00606619|"     The aim of this study is to determine whether early oral feeding after curative resection for     gastric cancer would be tolerable and give an effect on the recovery.   "
245103|NCT01069133|"     Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome     and metabolome.   "
210346|NCT00596206|"     To assess the efficacy response rate at 3-months of two dosing regimen of leflunomide in     DMARDs-naive patients presenting an early-RA using American College of Rheumatology 20%     response rate.      To assess the clinical efficacy at 1-month and 3-month using complementary efficacy criteria     (ACR 50, ACR 70, DAS 28) in each group of treatment, To assess the clinical and biological     safety using standard blood monitoring, TEAED and SAE in each group of treatment, To evaluate     treatment modifications; particularity leflunomide and concomitant use of AINS and     corticoids.   "
210347|NCT00596219|"     The purpose of this study is to better understand how to use celecoxib, a popular drug widely     used for arthritis, for head and neck cancer patients. Some doctors believe that celecoxib     may have helpful effects when used for head and neck cancer. Celecoxib has been shown to     prevent some cancers in animals. It has also been used to make standard chemotherapy and     radiation work better in both animals and humans. However, all of the previous studies     focused on tumors outside the head and neck region. To better understand how to use celecoxib     for head and neck cancer patients, doctors at MSKCC are studying the effects of the drug on     certain chemicals in the body that are thought to be important for cancer treatment.      This study aims to measure how celecoxib affects those chemicals, which can be found in the     tumor, blood, and urine of patients with head and neck cancer. Although celecoxib is already     used to treat arthritis, this study will be the first to test the drug in head and neck     cancer patients.   "
210348|NCT00596232|"     The purpose of this study is to investigate how mucus (phlegm or spit) is broken down once it     forms in the airways (bronchial tubes) of people with lung disease. This research study will     also examine whether blood groups have an effect on lung function or the type of mucus found     in the lung. This study is not designed to be a treatment for asthma, emphysema, cystic     fibrosis, or other lung disease. It is designed to help the investigators learn more about     the causes of airway disease.   "
210349|NCT00596245|"     This is an open-label, parallel group, single-center study. The study design consists of a     screening and a treatment period. A total of 42 (approximately 21 of each sex) non-smoking     healthy volunteers aged 18 - 35.   "
210350|NCT00596258|"     A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous     cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the     safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.   "
210351|NCT00596271|"     The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51     (JE-PIV) single and concomitant with HAVRIX® 1440   "
210352|NCT00596284|"     This study will evaluate the effectiveness of cognitive behavioral therapy in treating     anxiety in older adults with dementia.   "
210353|NCT00596297|"     The purpose of this study is to determine whether preoperative intravitreal bevacizumab is     effective in reducing intra-operative and postoperative bleeding in diabetic patients     submitted to pars plana vitrectomy for vitreous hemorrhage.   "
210354|NCT00596310|"     Lung cancer is the number one cancer killer in Kentucky and has a very high incidence within     the 5th Congressional District of Kentucky (110.8 cases per 100,000 in period 1996-2000).     Surgical removal provides the best chance for cure. Unfortunately, the majority of lung     cancer cases are detected in an advanced stage, when surgical resection is impossible. This     leads to shorter survival rates and increased mortality rates for lung cancer, increased     patient suffering, and greater cost to the healthcare system. Methods that favor earlier     detection are therefore crucial for successful treatment. One such method, low-dose spiral     computed tomography (CT) is being studied to determine whether its use as a screening method     will lead to earlier detection and earlier intervention, perhaps impacting survival and     mortality in lung cancer. This method has a modest sensitivity to detect lung cancer, but low     specificity, which leads to many false positives and a low negative predictive value. The     present study is designed to address both of these limitations by: 1) identifying individuals     in the population at highest risk for developing lung cancer (due to smoking habits and     decreased pulmonary function) for subsequent CT screening, and 2) performing biomarker     testing in conjunction with the CT scan to improve the ability to discern individuals with     benign lung nodules from those with malignant tumors. The 5th Congressional District of     Kentucky has one of the highest rates of lung cancer in the nation and is an ideal location     to test the validity (sensitivity and specificity), feasibility (negative and positive     predictive value), and efficacy (stage distribution shift to earlier stage disease, increased     survival, and decreased cancer-specific mortality) of these strategies to enhance early     detection.   "
210356|NCT00596336|"     The purpose of the study is to determine whether it is possible to improve the immune     response rate to 'flu vaccination in patients with chronic lymphocytic leukaemia (CLL).      Annual flu vaccination is recommended for all patients with CLL because they are known to be     susceptible to infections and particularly to chest infections that may occur as a     complication of influenza. Protection against 'flu depends on patients having a high level of     antibodies against the 'flu virus. Vaccination works by stimulating the immune system and     thus boosting the levels of these protective antibodies.      CLL patients have weakened immune systems due to the leukaemia itself but also following     chemotherapy. The exact cause of these immune defects is not known. However, CLL patients     typically have low antibody levels and their immune cells may not work normally.      Unfortunately, studies have shown that patients with CLL are not very good at making     antibodies to 'flu vaccination and as a result protection against flu is not very reliable.     Recent studies have shown that only 15-20 % of CLL patients will achieve a protective     antibody level.      Recently a new type of medical cream has been introduced to treat certain skin conditions.     Its name is Imiquimod and it is licensed to treat viral warts in the genital area and a type     of skin cancer called basal cell carcinoma. It works by increasing the immune response in the     skin. Animal studies have shown that as well as increasing immunity against viruses and     cancers, it increases responses to vaccination when applied at the site of vaccination.      In this study we propose to test whether this new medicine can improve the response to the     'flu jab.   "
210458|NCT00604565|"     In maintenance hemodialysis patients, regular administration of parenteral iron by addition     of soluble ferric pyrophosphate (SFP) to the dialysate, when compared to conventional     dialysate, is effective in preventing the development of iron deficiency, thereby maintaining     hemoglobin level; is clinically safe and does not lead to oxidative stress or inflammation.   "
210357|NCT00596349|"     The purpose of this study is to help us learn more about how women who have had or now have     ovarian cancer are doing 5 years or more from their diagnosis. We want to learn about general     quality of life, long-term side effects of treatment, sexual function, thinking, memory, and     psychological effects (such as anxiety and depression). We will also look at how these women     are being followed for ovarian cancer. We hope this study will help us better understand how     women surviving ovarian cancer are doing.   "
210358|NCT00596362|"     The purpose of this study is to test the safety and effectiveness of Avastin introduced into     the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye).     Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors.   "
210359|NCT00596375|"     In Emergency Departments (ED) across the nation there is renewed interest in finding ways to     alleviate the pain and discomfort associated with many of the procedures that children must     undergo. In a policy by the American Academy of Pediatrics, a nationally recognized advocate     for children, physicians are urged to advocate for child-specific research in pain management     and the effective use of pain medication to ensure compassionate and competent management of     pain. (AAP Statement, 2001) Pediatric urethral catheterizations are one such procedure in     which children experience significant pain.(11) In present care, children over 2 months of     age do not routinely receive intervention for urethral catheterization related anxiety and     pain, and, anecdotal reports suggest that most require physical restraint to complete the     procedure. Lidocaine is an anesthetic agent that provides relief from pain during many     commonly performed ED procedures. Intraurethral Lidocaine has been shown to decrease pain     associated with urethral catheter placement in cystograms, however, Lidocaine is not     routinely used for urethral catheterizations in the CHOA ED.      This study aims to investigate the potential use of Lidocaine as an anesthetic agent during     urethral catheterization of children. Recently, two specific studies were performed     investigating the use of Lidocaine to decrease discomfort associated with urethral     catheterization. Using the strengths of both previously published studies, our study will use     Lidocaine both topically and instilled into the urethra. Investigators plan to perform a     prospective three-arm double-blinded randomized clinical trial investigating the     effectiveness of Lidocaine jelly as a analgesic when used as a lubricant for urinary     catheterization. Investigators aim to demonstrate that Lidocaine used as a lubricant     anesthetic for urethral catheterization will provide a safe, time-efficient, and relatively     easy way to decrease pediatric pain in the emergency department setting.   "
210360|NCT00596388|"     Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD     patient to use the HMP device.   "
210361|NCT00596401|"     Recently, the preventive effect of Helicobacter pylori (Hp) eradication treatment on the     incidence of gastric cancer has been reported. By Hp eradication treatment being performed     for Hp-infected people in Iijima town, we will evaluate whether the incidence of gastric     cancer and/or the medical care cost can be reduced as compared with those in the previous     years.   "
210362|NCT00596414|"     Transjugular liver catheterisation allows the measurement of hepatic venous pressure gradient     (HVPG) and the sampling of liver tissue but patient's tolerance to the procedure is unknown.     The aim of this study was to assess tolerance to transjugular hepatic liver biopsy with or     without conscious sedation/analgesia.   "
210363|NCT00596427|"     The mechanism by which colesevelam HCl lowers glucose is not known. Knowledge of the     potential mechanism of action is important for defining the role of the drug among oral     antidiabetic agents available for use in subjects with diabetes. The objective of this study     is to provide insight into the mechanisms of action of colesevelam HCl in T2DM. The     mechanisms of interest include hepatic insulin sensitivity, rate of appearance of exogenous     glucose and changes in incretin hormone concentrations.   "
210364|NCT00596440|"     A teachable moment (TM) refers to life events or transitions, such as physician visits, early     detection screening feedback, pregnancy, and hospitalization for, and diagnosis of, disease,     that inspire health behavior change. Despite strong intuitive appeal of the TM concept and     over 150 studies of interventions implemented in a TM, there has been little investigation of     the influence of TMs for smoking, particularly for promoting smoking cessation among those     indirectly affected by a TM (e.g., relatives of cancer patients). This prospective     observational study using a matched-group design will assess whether a lung cancer diagnosis     increases enrollment in a smoking cessation program and cessation, and reduces smoking, among     the patient's relatives/spouse who smoke. We will compare enrollment in a cessation program     and cessation and smoking rates in 2 groups of smokers: 1) relatives/spouses of     newly-diagnosed lung cancer patients, and 2) relatives/spouses of patients with an orthopedic     condition. We will also explore mediators and moderators of a lung cancer diagnosis as a TM.     This study could clarify the TM concept for smoking cessation, shed light on the underlying     mechanisms of TMs, and guide future development and implementation of TM-based smoking     cessation interventions.   "
210365|NCT00596453|"     Ciprofloxacin hydrochloride has been approved by the Food and Drug Administration (FDA) for     the treatment of mild to moderate infections, including prostate infections. It has been     suggested that antibiotic treatment influences PSA levels due to the fact that an increase in     PSA levels may be caused by inflammation or swelling of the prostate. Antibiotics are used to     treat such inflammatory conditions. However, it has not been proven that antibiotics can be     used to lower PSA. This research is being done to see if treatment with the antibiotic     Ciprofloxacin hydrochloride affects the Prostate-Specific Antigen (PSA) blood test. This     study may also help doctors in deciding which patients need a prostate biopsy.   "
210367|NCT00596479|"     The purpose of this study in humans with stable coronary artery disease (CAD) treatable by     PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of     subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF     (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.   "
210368|NCT00596492|"     The primary objective of this study is to test the hypothesis that DYME is safe and effective     as a drug to facilitate continuous curvilinear capsulorhexis (CCC) by selectively staining     the anterior capsule. Secondary objectives are to compare the safety and effectiveness of     DYME to that of a smaller dose of the same API.   "
210399|NCT00596908|"     This study is designed to obtain an imaging training set that will be used to evaluate images     in future trials. Currently, no radiopharmaceutical diagnostic imaging agent has been     approved by the FDA in the U.S. for use in diagnosing Parkinson disease and related     Parkinsonian syndromes. The diagnosis of Parkinsonian syndromes in the U.S. is based on     clinical criteria only. The goal is to demonstrate that 123I-ALTROPANE® paired with SPECT     imaging permits a more accurate early diagnosis of Parkinson disease than a clinical     diagnosis by a general neurologist.   "
210400|NCT00596921|"     This study proposes to examine the correlation of central venous pressure to measures of the     diameter of the inferior vena cava as determined by bedside ultrasonography.   "
210471|NCT00604734|"     This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip     Resurfacing System.   "
210369|NCT00596505|"     Treatment of severe proliferative diabetic retinopathy (PDR) may require the use of silicone     oil for long-term retinal tamponade to prevent recurrent retinal detachment. Massive bleeding     during surgery before proper release of traction and peri-silicone oil proliferation after     surgery were major causes of surgical failure. The likelihood of reproliferation rises in the     presence of significant preretinal blood. It is therefore crucial to reduce intraoperative     and postoperative preretinal hemorrhage in complicated diabetic vitrectomy with silicone oil     infusion.      Intravitreal avastin has been noted to induce rapid regression of retinal and iris     neovascularization in proliferative diabetic retinopathy. Further, presurgical administration     of intravitreal avastin may reduce intraoperative bleeding during membrane dissection in PDR     with traction retinal detachment. The pretreatment of avastin may be particularly beneficial     in the treatment of severe active fibrovascular proliferation by decreasing the severity of     intraoperative and postoperative intraocular hemorrhage, leading to better surgical outcome     and early visual rehabilitation.      We conduct a prospective study to evaluate the effect of avastin on the severity of intra-     and post-operative bleeding, frequency of recurrent bleeding, and anatomical and functional     outcome in eyes with severe active PDR undergoing vitrectomy with silicone oil infusion.   "
210370|NCT00596518|"     The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down     and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects     receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate     of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200     in subjects with various degrees of kidney function or undergoing chronic hemodialysis will     be assessed.   "
210371|NCT00596531|"     The objective of this project is to determine whether acamprosate is more effective at     providing relief for tinnitus than a placebo.      Acamprosate has been suggested to be effective in reducing tinnitus annoyance in a     preliminary study. Study evidence indicates that tinnitus is related to increased excitatory     spontaneous brain activities. Acamprosate may help restore the excitatory/inhibitory balance     in the brain and thus reduce tinnitus.      The current study includes three phases. The first phase is an open-label screening study     used to identify tinnitus subjects responding to acamprosate. These responding subjects will     enter the second phase, which is a double blind, placebo-controlled study aimed at confirming     the subjects' responses to acamprosate. In the third phase, clinical parameters of both     responders and non-responders will be compared using a multi-linear regression model to     determine characteristics that define the sub-group of tinnitus patients that are likely to     benefit from acamprosate treatment. Participation in the study requires that individuals come     to Portland, Oregon at least 6 times over 16 months for evaluation and data collection.   "
210372|NCT00596544|"     The purpose of this study is to help us learn more about sexual problems after treatment for     ovarian cancer. At this time, we do not know how many women have sexual problems after they     are treated for ovarian cancer.      How common are sexual problems after treatment for ovarian cancer?        -  What factors make women more likely to have sexual problems after treatment for ovarian          cancer?        -  What happens to sexual functioning over the first 12 months after treatment? ie.      Does it get better or worse?      • Does referral to a specialized sexual health clinic help?   "
210373|NCT00596557|"     The different mechanisms of action of Everolimus and cyclosporine suppress immune function in     synergistic manner. Thus it is postulated that the use of Everolimus in combination with     cyclosporine permits a significant cyclosporine dose reduction without loss of     immunosuppressive activity in the clinical setting.      The aim of the present study is to evaluate the evolution of renal function after initiation     of Everolimus and minimalisation of CNI dose.   "
210374|NCT00596570|"     Treatment of patients suffering from atrial fibrillation pose problems when percutaneous     coronary intervention with stent implantation (PCI-S) is performed. In the absence of solid     evidence-based data, no definite recommendations for the management of this patient subset     are currently given in the guidelines on percutaneous coronary intervention issued by the     most prominent Cardiology Associations. The management of the antithrombotic treatment before     invasive cardiac procedures is also incompletely defined. In this study we aim to determine     in patients with atrial fibrillation undergoing PCI-S:        1. the contemporary antithrombotic management;        2. the relative safety and efficacy of the various post-PCI antithrombotic regimens;        3. the safety and efficacy of drug-eluting stents (DES), bare-metal stents (BMS), and          bioactive stents (BAS);        4. the safety of various periprocedural antithrombotic strategies including glycoprotein          IIb/IIIa inhibitors and bivalirudin;        5. safety and efficacy of radial vs femoral approach.   "
210375|NCT00596583|"     The primary objective of this study is to test the hypothesis that DYME is safe and effective     as a drug to facilitate continuous curvilinear capsulorhexis (CCC) by selectively staining     the anterior capsule. Secondary objectives are to compare the safety and effectiveness of     DYME to that of a smaller dose of the same API.   "
210376|NCT00596596|"     The purpose of the study is to determine whether prucalopride is safe and effective in     patients with chronic idiopathic constipation.      Hypothesis:      At all doses administered prucalopride given once daily for 4 weeks is safe and well     tolerated in patients with chronic idiopathic constipation.   "
210453|NCT00604500|"     This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F)     metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI     50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of     age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease     (COPD) of at least 12 months. The primary purpose of the study was to evaluate the     performance of the MF/F MDI integrated dose counter under normal patient handling conditions.   "
210457|NCT00604552|"     The aorta is a large blood vessel that carries blood away from the heart to the organs in the     rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in     the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break     open) with fatal consequences. Abdominal aortic aneurysm (AAA) is a life-threatening lesion     that has been treated in recent year via endovascular repair.      The purpose of this study is to monitor the long term performance of the AneuRx Stent Graft     Systems.   "
210614|NCT00606632|"     This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250     PET/CT pre-surgical imaging in patients with operable renal masses.   "
210377|NCT00596609|"     Patients undergoing posterior spinal fusion (PSF) procedures for scoliosis are at risk for     iatrogenic neurologic injury of the spinal cord and/or spinal nerve roots during surgical     correction of the abnormal spinal curvature. The degree of neurologic injury can range from     minor sensory deficits to complete paraplegia. Surgeons at CHOP utilize neurophysiologists to     identify impending neurologic injury. These consultants monitor spinal cord pathways by     recording and analyzing evoked potentials during the operation. Evoked potentials are low     voltage electrical signals generated in response to transcranial or transcutaneous electrical     stimulation of motor and sensory neural pathways.      Some patients undergoing PSF receive an injection of morphine into the cerebrospinal fluid     during the operation. This intrathecal (IT) morphine has potent analgesic effects. While most     commonly used anesthetic agents have well-characterized effects on evoked potentials, little     data exists on the effects of IT morphine on transcranial electric motor-evoked potentials     (TceMEPs).      This is a prospective observational study to characterize the effects of IT morphine on     TceMEPs.   "
210378|NCT00596622|"     This study will assess the effects of bipolar disorder on brain activity and will determine     if medication changes the brain activity in people with bipolar disorder.   "
210379|NCT00596635|"     Urinary tract infections (UTIs) affect over 7 million men and women per year and cost the     health care industry over 1 billion dollars annually. The incidence of UTI increases markedly     in elderly institutionalized persons and leads to excessive antimicrobial usage, emergency     room visits, hospitalization, sepsis, and death. The use of antimicrobials to prevent UTI in     elderly nursing home patients is not recommended and is fraught with problems such as adverse     reactions, drug interactions, and the development of drug-resistant organisms. There is no     accepted method of preventing UTI in residents of nursing homes, a vulnerable and     understudied population with significant morbidity from UTI.      The overall goal of this proposal is to conduct a prospective cohort pilot study that     evaluates the feasibility of using cranberry to prevent UTI in nursing home residents. Each     of the aims is critical for the optimal design of a larger placebo-controlled, definitive     trial of cranberry for prevention of UTI in nursing home residents and will provide the     essential preliminary data for future larger studies.   "
210380|NCT00596648|"     In Phase 1 of this study, the purpose is to evaluate the safety, tolerability, and highest     safe dose of the multiple receptor tyrosine kinase inhibitor (including VEGFR2, MET, and RET)     XL184 in combination with the EGFR inhibitor erlotinib administered to adults with     Non-Small-Cell Lung Cancer (NSCLC). In Phase 2 of this study, the purpose is to evaluate the     objective response rate of daily oral administration of XL184 with or without erlotinib in     subjects with NSCLC who have progressed after responding to treatment with erlotinib.   "
210381|NCT00596661|"     The primary objective of the trial is to demonstrate the safety and feasibility of treating     coronary artery lesions which have not been previously treated with the TRIMAXX Coronary     stent system as compared to the reported results for commercially available non-drug eluting     coronary stent systems which are indicated for the same treatments.   "
210382|NCT00596674|"     Women with chronic disabling conditions such as fibromyalgia syndrome (FMS) must manage a     wide variety of disease-related, intrapersonal, and environmental demands to maintain their     health and quality of life. Engaging in health-promoting behaviors is one strategy     recommended to manage disease symptoms and enhance quality of life (USDHHS, 2000). The     purpose of this four-year study is to refine and test a theoretically and empirically based     intervention to promote the health and well being of women with the chronic disabling     condition of fibromyalgia. We hypothesize that women who participate in the Lifestyle     Counts Intervention will report more greater self-efficacy for health behaviors, more     frequent health behaviors and more positive health and quality of life than women in the     comparison group.   "
210383|NCT00596687|"     High blood glucose levels in surgical patients with diabetes are associated with increased     risk of medical complications and death. Improved glucose control with insulin injections may     improve clinical outcome and prevent some of the hospital complications. In patients who have     undergone surgery, high blood glucose increases the risk of wound infection, kidney failure     and death. It is not known; however, what is the best insulin regimen in patients who will     undergo surgery. The use of repeated injections of regular insulin is commonly used for     glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus®     and Apidra® insulins has been shown to improve glucose control with lower rate of     hypoglycemia (low blood sugar). We hypothesize that in patients with type 2 diabetes admitted     to general surgery wards, treatment with once daily glargine (Lantus) plus supplemental     glulisine insulin (Apidra®) will produce better glycemic control and a lower rate of hospital     complications than treatment with regular insulin per sliding scale (SSRI). The present study     aims to determine which insulin treatment is best for glucose control in hospitalized     patients with diabetes. Glargine and glulisine insulins are approved for use in the treatment     of patients with diabetes by the FDA.      Subjects included in the study will have type 2 diabetes and be admitted to Grady Memorial     Hospital, Veterans Administration Medical Center, and Emory University Hospital, Atlanta,     Georgia. A total of ~94 patients will be recruited at each institution.      A post-hoc cost analysis of hospitalization costs and charges of the Rabbit surgery trial     will be completed in order to determine differences in hospitalization cost between basal     bolus insulin and SSI regimen.   "
210384|NCT00596700|"     The Study        1. Prospective trial of the Niv score validating score against known activity indices - see          addendum A for Niv score        2. Known Crohn's disease patients undergoing capsule endoscopy are identified - see          addendum B for inclusion/exclusion criteria        3. Prior to capsule exam, temperature is taken, height and weight measured, bloods are          drawn for albumin, ESR, HCT, CRP        4. Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for          questionnaire        5. Capsule exam is performed        6. CD of de-identified is made at the study site.        7. Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled          on thumbnails        8. CDs are copied        9. CDs of study patients are provided to blinded readers   "
210454|NCT00604513|"     The goal of Ready, Set, ACTION! (RSA) is to test the feasibility of implementing a     theater-based after-school program to promote healthy eating, physical activity, and positive     body image with children in grades four through six.   "
245573|NCT01063894|"     The objective of this study is to test the effects of breakfast on cognitive processing     ability in children.   "
210385|NCT00596713|"     Sleep disturbances are of great relevance within the context of public health as they affect     a sizable portion of the population with far reaching consequences. Many automobile and labor     accidents as well as poor school and work performance can be traced to sleep disturbances,     which are also linked to cardiovascular disease, metabolic syndrome, and psycho-cognitive     alterations.      OBJECTIVES:        1. Establish the epidemiologic profile of sleep disturbances among the adult population of          the city of Sao Paulo in 2007;        2. Investigate associations between sleep patterns and disturbances in that population,          taking into account the following variables: social-demographic status, anthropometrics,          clinical, activity/rest cycle, eating and physical activity habits, mood disturbances,          sexual dysfunction in males, alcoholism, drug addiction, genetic markers, biochemical,          hematological, endocrine, immunologic and inflammatory indicators;        3. assess the compatibility of the results collected in the current study with those of          epidemiologic sleep investigations of said city carried out in 1987 and 1995 with the          aim of determining the secular sleep disturbance trend.      METHODS:      The two-stage cluster randomized sample included 1100 individuals of the city of Sao Paulo,     representing the population proportionally to gender, age groups and social classes. Data     were amassed as follows:        1. the application of home and institution questionnaires;        2. description of the sleep patterns and disturbances through polysomnography and          actigraphy, performed at the Sleep Institute;        3. collection of peripheral blood for biochemical, hematologic, endocrine and genetic          assays.      STATISTICS:      Subsequent to double typing (inputting) and analysis of data consistency, descriptive and     analytical statistical assessments will be performed with the aim of describing patterns of     sleep disturbances associated to the explanatory variables under investigation. In the light     of bi-varied analysis, predictive/explanatory multivaried models were adjusted.   "
210386|NCT00596726|"     To demonstrate that that the device is safe and potentially efficacious for use as a left     ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support     post weaning from cardiopulmonary bypass.   "
210387|NCT00596739|"     A correlation between obesity and male fertility has been observed in a few clinical studies.     Normal weight men appear to have higher sperm concentrations and sperm motility when compared     to obese men, suggesting that weight loss might improve sperm function. However, there also     are reported cases of severe male factor infertility following weight loss surgery in     previously fertile men. The aim of this study is to determine if there are differences in the     semen analyses and hormone levels of men obtained before and after undergoing weight loss     (bariatric) surgery.      This will direct future research and treatment.   "
210388|NCT00596752|"     The study is to confirmatorily show a superior effect of Alprostadil compared to placebo on     the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency     and height of major amputations in patients suffering from PAOD stage IV.   "
210389|NCT00596765|"     Acquired brain injury can result in impaired everyday functioning as well as psychosocial     problems, including depressive symptoms, irritability, or negative self-concept. The purpose     of this study is to determine whether a combination of neuropsychological and cognitive     behavioral therapy is effective in the treatment of these sequelae.   "
210390|NCT00596778|"     Abdominal surgical procedures can increase risks of pulmonary complications.The aim of the     study was to evaluate the benefits of an early intervention of chest physiotherapy during     immediate post-operative in patients submitted to elective abdominal surgery.   "
210391|NCT00596791|"     The purpose of this study is to investigate if changes in ocular signs and symptoms occur in     patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005%     (Xalatan) to preservative free Tafluprost eye drops.   "
210392|NCT00596804|"     This study is being done to assess the safety and tolerance of different doses of humanized     hA20 in patients with NHL.   "
210393|NCT00596817|"     This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major     depressive episodes in patients who responded to open-label treatment with Vortioxetine.   "
210394|NCT00596830|"     Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin     prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or     metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.   "
210395|NCT00596843|"     The purpose of this study is to determine if a 6-session motivational interviewing     intervention is more effective than a 6-session educational intervention at reducing     behaviors that may lead to infection, transmission, and progression of HIV and hepatitis C     among out of treatment injecting drug users.   "
210396|NCT00596856|"     Purpose:        1. Revise the existing oral health risk assessment tool (known as the Encounter Form in the          IRB-approved project DENT-1527) and develop accompanying guidelines for its use and          distribution.        2. Evaluate the education intervention to accompany the distribution of the new risk          assessment tool - the Priority Oral Health Risk Assessment and Referral Tool - PORRT and          guidelines.        3. Evaluate the extent to which the education intervention affects physicians' screening          and referral performance (use of guidelines, appropriateness and quality of referrals).      Participants: Primary care medical and dental providers in North Carolina.      Procedures (methods): UNC will engage in a systematic literature review of dental caries risk     and a simulation analysis in order to finalize the design of the PORRT referral tool and its     accompanying guidelines. Medical providers will be surveyed statewide regarding their oral     health screening practices with children under three years of age, and a randomized     controlled trial will be implemented in 75 of these practices to evaluate guideline     dissemination and effectiveness. Referral behavior will be evaluated through an analysis of     the completed PORRT forms and a record review in dental practices serving as referral sites.     Medicaid claims analysis will determine referral effectiveness for the RCT sites compared to     the state as a whole.   "
210397|NCT00596882|"     The proposed study has been designed to examine the effect of a message that primes genetic     susceptibility on actual enrollment in a smoking cessation program, actual response to     smoking cessation treatment, and potential moderators and mediators of this effect.   "
210398|NCT00596895|"     Primary Outcome Measures:      Decrease in rate of serum PSA rise      Secondary Outcome Measures:      Adherence to treatment regimens      Quality of life as assessed by FACT-P at baseline and at 12 months of treatment      Modulation of serum testosterone,isoflavone metabolites, and cholesterol      Estimated Enrollment: 27 Study Start Date: November 2003 Estimated Primary Completion Date:     February 2007 (Final data collection date for primary outcome measure)   "
210551|NCT00605813|"     Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety.     The objective of this Special investigation is to collect information about 1) adverse drug     reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of     adverse drug reactions in this surveillance, and 3) factors considered to affect the safety     and/or efficacy of this drug regarding long time use.   "
210401|NCT00596934|"     Nonalcoholic steatohepatitis (or NASH) is known to be caused by deposition of fat in the     liver and development of scarring. This condition occurs more frequently in overweight and     obese persons. It is often associated with resistance to the actions of insulin hormone. Fat     cells secrete a hormone called leptin. Recently, we have learned that obese or overweight     persons make too much leptin, which may contribute to insulin resistance. Paradoxically,     patients who do not have any fat cells, also have insulin resistance. In these patients,     insulin resistance is caused by the absence of leptin and leptin replacement significantly     improves insulin resistance and fat deposition in the liver. In an earlier study, we     determined the leptin levels in patients with NASH and how these levels are related to body     fat levels as well as responsiveness to insulin. We saw that a subgroup of patients with NASH     have relatively low levels of leptin in contrast to the amount of body fat they had. We now     would like to see if restoring leptin levels to normal will improve the disease process in     these patients. Our study patients will be male patients, aged between 18 and 65 (inclusive),     who do not have any other cause for their liver disease. We have put some restrictions in     body size such that a spectrum of patients from normal weight to obese range would be     included. They will also demonstrate low leptin levels (levels similar to only 25% of normal     population). We will use a genetically engineered form of leptin manufactured by Amylin Inc.     given via injections under the skin. We plan to continue therapy for a period of one year and     evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic     parameters and body composition characteristics that we examined in our earlier study. We     expect that patients with low blood leptin levels will show improvement in their liver     disease and insulin resistance when their blood leptin levels are restored to normal.   "
210402|NCT00596947|"     The purpose of the study was to determine if rapid discontinuation of corticosteroids (also     known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus)     and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte     globulin) will give similar safety and efficacy results compared to continuation of     corticosteroids (also known as prednisone maintenance) and standard maintenance     immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using     Thymoglobulin (Rabbit antithymocyte globulin).   "
210403|NCT00596960|"     The purpose of this study is to determine whether motivational enhancement therapy (MET)     reduces alcohol use in a population of HCV-infected veterans who are currently drinking     alcohol and have alcohol disorders. We hypothesize that veterans with HCV, an alcohol use     disorder and continued excessive alcohol use who receive MET will have a greater reduction in     the number of standard alcohol drinks per week and a greater percentage of days abstinent     than veterans who receive health education control intervention.   "
210404|NCT00596973|"     The aim of this study is to assess the short term success and feasibility of ileal     transposition with sleeve gastrectomy in non-morbidly obese patients with poorly controlled     Type 2 Diabetes Mellitus   "
210405|NCT00596986|"     The purpose of this study is to determine how psychotherapy and pharmacotherapy respectively     change brain activity in patients suffering from chronic depression.   "
210406|NCT00596999|"     To investigate the safety of partially matched related human placental-derived stem cells     (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells from the same     donor in subjects with various malignant or nonmalignant disorders potentially curable with     stem cell transplantation and to assess potential restoration of normal hematopoiesis and     immune function in subjects with these disorders   "
210407|NCT00597012|"     There are two cartilage structures, called menisci, in each knee joint. A torn meniscus can     be caused by a traumatic injury or aging-related degeneration. Osteoarthritis (OA) is a type     of arthritis that is caused by the breakdown and eventual loss of another type of cartilage     that covers the end of bones within a joint. In people who have knee OA, a meniscal tear can     easily lead to disability. This study will compare the effectiveness of two recommended     treatments, surgery and physical therapy, for people with a torn meniscus and knee OA.   "
210408|NCT00597025|"     This study is to evaluate the impact of providing high protein supplementation in the form of     a medical food bar containing 20grams of protein eath to hypoalbuminemic dialysis patients.   "
210409|NCT00597038|"     The purpose of this study is to:      Phase I Objectives:        -  Find the most tolerated dose to use for Phase II        -  Collect information on how the body responds to this combination of study drug      Phase II Objectives:        -  To determine the overall response of participants using this combination of study drug      The expression of proto-oncogene tyrosine-protein kinase (Src), a substance present in a     significant proportion of melanomas plays a role in the growth, multiplying, and dividing of     cancer cells. Melanoma cells appear to be sensitive to these agents that block the action of     Src in concentrations that can be achieved in patients. We suggest that Src inhibitors (such     as Dasatinib) may be a good choice for treatment of melanoma in combination with Dacarbazine     (a chemotherapy drug that can cause the shrinkage of melanomas). We wish to to evaluate the     Src inhibitor Dasatinib in combination with the chemotherapy drug Dacarbazine. The novel oral     Src inhibitor Dasatinib may be able to increase the effectiveness of chemotherapy for     melanoma compared to chemotherapy alone. Dacarbazine is a standard treatment for melanoma     currently. The effectiveness of this chemotherapy drug may be increased by combination with     Dasatinib. Dacarbazine has been approved by the US Food and Drug Administration (FDA) for     treating melanoma; Dasatinib has been approved by the FDA to treat leukemia, but it has not     been approved alone or in combination with Dacarbazine to treat melanoma.   "
210410|NCT00597051|"     The purpose of this study is to determine which dose, if any, results in testosterone levels     within the normal range for men.   "
210522|NCT00605397|"     The purpose of this study is to learn more about how a new study agent works inside the body.     The study agent is a protein called 64Cu-trastuzumab. This is a radioactive tracer that was     developed at MSKCC to target HER2 protein on cancer cells. A radioactive tracer is a small     amount of radioactive dye that follows something else that is not radioactive In this study     the study agent, 64Cu-trastuzumab, is the tracer and what's being followed is trastuzumab     (Herceptin™). By giving you this tracer after you have treatment with trastuzumab     (Herceptin™), we will be able to use PET scans to show us which parts of your body and tumor     sites the Herceptin goes to. This will help us to understand better how Herceptin works in     the body to fight cancer.   "
210440|NCT00604331|"     Pyruvate is an intermediate of energy metabolism and was shown to possess pronounced positive     inotropic effects in vitro and in vivo without altering myocardial oxygen consumption.     Moreover, it was shown that the effects of beta-adrenergic stimulation were potentiated.     Thus, it might be possible to save catecholamines in patients with severe heart failure or     cardiogenic shock. This study was designed to test the hemodynamic effects of pyruvate     administered into a coronary artery in addition to intra-aortic balloon pump counterpulsation     in patients with severe heart failure or in patients with acute myocardial infarction and     cardiogenic shock after having performed percutaneous coronary intervention. A pronounced     improvement in hemodynamics is expected to occur.   "
210411|NCT00597064|"     The goals of control status of asthma have been changed with the improvement of its     management as a chronic disease; many steps should be taken to achieve asthma control as     defined by the GINA/NIH guidelines. There are good results with single variables, but overall     asthma control should be addressed in different ways. Most traditional clinical studies     provide an incomplete assessment of disease control, despite good clinical practice. The     association of inhaled corticosteroid (IC) and long-action beta 2 agonist (LABA) has already     showed their efficacy to reduce asthma symptoms, exacerbations and cost for moderate and     severe asthma patients as well as the improvement in their quality of life. On the other     hand, even with the use of first line maintenance medication, as recommended by guidelines,     some asthmatic patients fail in obtaining a total control of the disease. This lack of     efficacy, led us to hypothesize, that these patients who fail in response, would present     chronic and fixed airway obstruction as a consequence of persistent inflammation and airway     remodeling. This study has the purpose of looking for an adequate composite measure to     provide an indicator of overall asthma status more accurately and meaningfully as reflect of     treatment effectiveness and disease control. For this, we will test by a randomized control     trial if an additional oral corticosteroid treatment could modify spirometric and     plethysmography values, nasal and low airway cytology and HRCT (to evaluate small airway) in     regularly treated stable asthma patients who have a positive bronchodilator response.   "
210412|NCT00597077|"     Heart failure is a clinical syndrome where the heart is unable to pump enough blood to     satisfy the organism's metabolic needs. Heart failure has become a major clinical and public     health problem with approximately 300,000 Canadians being affected. Atrial fibrillation is a     rhythm disorder in which the upper chambers of the heart (the atria) are paralyzed by     continuous electrical activity. Some of the continuous chaotic electrical activity in the     atria travels to the lower cavities of the heart (the ventricles) causing then to beat     irregularly and very rapidly. It is the most frequent cardiac arrhythmia, affecting 5% of     individuals 65 years and older and it is associated with an increased risk of stroke. Both     conditions (heart failure and atrial fibrillation) often co-exist in the same patient. Heart     failure promotes atrial fibrillation and atrial fibrillation aggravates heart failure. The     Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is investigating whether     preservation of normal cardiac rhythm influences mortality and morbidity. The AF-CHF study     began in 2001 and 1,378 patients have been enrolled from 123 participating centres, in North     America, South America, Europe, and Israel. The results of this trial which are expected in     October 2007, will improve decision-making for the physician and will provide useful     information to healthcare organizations responsible for the care of heart failure patients.   "
210413|NCT00603772|"     To assess the potential of tretinoin gel 0.05% and its vehicle to produce photoallergic     reactions, measured as skin reactions following induction and challenge.   "
210414|NCT00603785|"     We propose to study the effects of Xolair on patients with chronic sinusitis with or without     nasal polyps. Because of the similarities between the inflammatory processes found in asthmas     and rhinitis to those found in chronic sinusitis, we hypothesize that sinusitis should     respond to Xolair, just as asthma.   "
210415|NCT00603798|"     The purpose of this study is to determine whether imiquimod creams are effective in treating     Actinic Keratoses when applied to the face or balding scalp.      Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the     sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient     contained in the study cream for this study is the same as that of the approved product     Aldara, which has shown to be safe and effective for the treatment of AKs.   "
210416|NCT00603811|"     This study will evaluate the safety and immunogenicity of VAX102 [Flagellin.HuM2e], a     recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of     doses.   "
210417|NCT00603824|"     The purpose of this study is to test the safety and efficacy of fondaparinux in patients with     heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with     HIT who are treated with fondaparinux experience a prompt and complete recovery of their     platelet count, and the secondary objective is to determine if any new blood clots are formed     while receiving the fondaparinux and up to one month after study enrollment. This information     will be compared to a historical control.   "
210418|NCT00603837|"     Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will     not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW)     babies who are placed on thermal warming blankets.   "
210419|NCT00603850|"     Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD     patient to use the HMP device.   "
210420|NCT00603863|"     This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination     with gemcitabine in patients with previously untreated pancreatic cancer.   "
210421|NCT00603876|"     The purpose of the study is to evaluate the effects of 100-110 grams of almonds (about ¾     cupful) daily on the lipoprotein profile when given to patients on a statin drug. The study     will compare the effects on the lipoprotein profile to patients who eat almonds and those     patients not eating almonds.   "
210422|NCT00603889|"     Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life     cycle. In a clinical study in previously hookworm-infected adults in Brazil, this protein     induced urticarial reactions (rash) in a subset of volunteers. This study will evaluate     solutions of varying concentrations of the protein in both a skin prick-puncture and     intradermal test that will eventually be used to screen volunteers living in hookworm endemic     areas who are being considered as potential participants in vaccine trials, to reduce the     potential of inducing allergic reactions in those vaccinated with the Na-ASP-2 Hookworm     Vaccine.   "
210423|NCT00603902|"     The purpose of this study is to assess the weight loss effect of lorcaserin during and at the     end of 1 year of treatment in overweight and obese patients.   "
210523|NCT00605410|"     Certain lung disease medications can influence diagnostic tests and research investigations.     This study will investigate how long ipratropium bromide must be withheld before a     methacholine challenge test can be conducted. This information will be useful for validating     current guidelines.   "
213084|NCT00640419|"     The purpose of this study is to test if the investigational medication ABT-089 is a safe and     effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD).   "
210424|NCT00603915|"     Cisplatin or Carboplatin will be given on day 1 every 21 days for 6 cycles; Gemcitabine will     be given on day 1 and day 8 every 21 days for 6 cycles. Those patients that do not progress     on GC after 6 cycles of chemotherapy will be started on erlotinib daily until disease     progression. A cycle of erlotinib will be 28 days. Patients who progress on GC will be     offered erlotinib as well,in order to evaluate its activity as a single-agent in the     second-line setting.      Patients previously treated with GC have reported a progression-free survival (PFS) of 9     months. We would anticipate an extension of PFS to 12 months in patients treated with GC     followed by maintenance erlotinib. Furthermore, we hypothesize that patients who achieved     benefit from GC therapy would have further response when treated with maintenance erlotinib,     such that this strategy may increase the likelihood of attaining long-term survival.   "
210425|NCT00603928|"     Physicians often have an ambivalent relationship to placebo interventions. On the one hand     they know of the intriguing effect of sugar pills or saline infusions but on the other hand     they mostly feel constrained to adopt scientifically proven, specific therapies for ethical     reasons. Against the background of international literature one can assume that also Swiss     general practitioners use several forms of placebo interventions in a significant part of     their patients.      The aim of the project is to ascertain to which extent and in which way Swiss general     practitioners make use of placebo interventions. Furthermore knowledge of the mode of action     of placebo interventions and the perceived moral and lawful permissibility of placebo     interventions and the presumed attitudes of the patients will be investigated.      The empicical core of the study is a questionnaire survey of general practitioners in urban     and rural areas of Switzerland. The results and conclusions of the survey will be discussed     during a workshop with interested GPs, researchers and ethicists.      The obtained data will lead to a better understanding of the application of placebo     interventions in the general practice in Switzerland (how often and in which manner,     accompanied by what information, for which diseases and for which patient groups placebos are     applied). Moreover the study will help to articulate potential moral ambiguities of     physicians using placebo interventions.   "
210426|NCT00603941|"     The Phase I/II study will be conducted as an open label, multiple center study of CS-7017, an     experimental drug and paclitaxel chemotherapy in subjects with advanced anaplastic thyroid     cancer. Biopsies will be obtained from patients with accessible tumor at baseline, two-weeks     after the first CS-7017 dosage (prior to the start of combination therapy) and at the end of     the first study cycle (week 3 of combination therapy), in order to evaluate the effects of     the study drug alone and in combination with the chemotherapy agent on the tumor. Treatment     will continue until disease progression or the development of intolerable toxicities.   "
210427|NCT00603954|"     The present project aims at comparing two nonmyeloablative regimens currently used in 2 major     HCT centers in the US for patients with HLA-matched related or unrelated donor: the one from     the Seattle group consisting of 2 Gy TBI with fludarabine (90 mg/m²) versus the one from the     Stanford group combining 8 Gy TLI with ATG.   "
210428|NCT00603967|"     The primary objective of this 2-year pilot project is to test the hypothesis that skeletal     response to aromatase inhibitors is determined by polymorphisms of the CYP19 gene.   "
210429|NCT00603980|"     Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and     Staccato Placebo.   "
210430|NCT00603993|"     The purpose of this study is to evaluate the long-term safety of subcutaneous (SC)     self-injections (by the subject or subject's family member) of adalimumab in adult Japanese     subjects with Rheumatoid Arthritis in an open-label study.   "
210431|NCT00604006|"     Individuals who were a part of the investigators Screen-HF study (NCT00400257) whose BNP     level are in the top quintile will be offered participation in this study. Participants will     be randomised to receive either spironolactone or placebo for three years. Participants will     then be monitored for indications of heart failure. It is anticipated that the medication     will reduce the development of heart failure in this group.   "
210432|NCT00604019|"     We are performing a prospective, randomized, controlled trial of dopamine versus     norepinephrine for septic shock. The trial will enroll patients with suspected or documented     site of infection and having 2 out of the three SIRS criteria. Patients will also be     receiving standard of care, early-goal directed therapy including but not limited to fluid     resuscitation, appropriate and early antibiotics, source control and evaluation for     drotrecogin alpha where deemed appropriate, while being supported for septic shock.   "
210433|NCT00604032|"     To assess the potential of tretnoin gel 0.05% to produce phototoxic reactions, measured as     skin reactions 24 and 48 hours after UV radiation of drug on skin.   "
210434|NCT00604045|"     The purpose of this study is to determine whether a computerized intervention designed to     change the nature of attention biases will be effective in reducing the symptoms of post     traumatic stress disorder (PTSD) in American combat veterans returning from the wars in     Afghanistan and Iraq.   "
210435|NCT00604058|"     The present study intends to investigate the use of fractional doses of sanofi pasteur's     IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the     non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full     doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio     types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14     weeks of age.   "
210436|NCT00604071|"     estimate the sensitivity of the HMP test in identifying visual field functional defects in     subjects with CNV secondary to AMD   "
210437|NCT00604084|"     The purpose of this project is to develop a community scabies eradication and education     program for the highly endemic areas surrounding the Veron community on the eastern tip of     the Dominican Republic. It proposes the use of oral Ivermectin as a replacement for topical     Lindane--a readily available medical formulation, pesticide, and environmental toxin that is     reported to be banned in the Dominican Republic as well as over 80 other countries throughout     the world.   "
210438|NCT00604097|"     The purpose of the study is to test the efficacy of a brief family therapy (Attachment-Based     Family Therapy) for youth presenting in primary care with suicidal ideation and depressed     mood.   "
210439|NCT00604318|"     To evaluate quality of life in patients after 10 days pause of thyroid medication     (Liothyronine) compared to treatment with recombinant TSH (Thyrogen) before radioiodine     uptake and treatment in a double-blinded, randomised cross-over design.   "
210442|NCT00604357|"     Background:      Patients undergoing liver transplantation with preexisting renal dysfunction are prone to     further renal impairment with the early postoperative use of Calcineurin-inhibitors. However,     there is only little scientific evidence for the safety and efficacy of de novo CNI free     regimens in patients with impaired renal function undergoing liver transplantation. The     objective of the study is to evaluate a de novo calcineurin-inhibitor-free immunosuppressive     regimen based on induction therapy with anti-CD25 monoclonal anti- body, mycophenolate     mofetil (MMF/MPA), and mTOR-inhibition to determine its safety and to investigate the     preliminary efficacy in patients with impaired renal function at the time of liver     transplantation. Methods/Design: Patients older than 18 years with renal impairment at the     time of liver transplantation due to hepatorenal syndrome, eGFR < 50 ml/min and/or serum     creatinine levels > 1.5 mg/dL will be included. Patients will receive a combination therapy     with antiCD25-monoclonal antibodies, MMF, steroids and delayed sirolimus (day 10) and will be     evaluated with regards to the incidence of steroid resistant acute rejection within the first     30 days after liver transplantation as the primary endpoint. The study is designed as     prospective two-step trial requiring a maximum of 29 patients. In the first step 9 patients     will be included. If 8 or more patients show no signs of biopsy proven steroid resistant     rejection, additional 20 patients will be included. If in the second step a total of 27 or     more patients reach the primary end-point the regimen is regarded to be safe and efficient.     The follow up period will be one year after transplantation. The aim is to obtain safety and     efficacy data for this new and innovative therapy regimen that might be the basis for a large     prospective randomized multicenter trial in the future.   "
210443|NCT00604370|"     An investigator initiated study exploring VTE prophylaxis at the time of hospital discharge.   "
210444|NCT00604383|"     This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three     years will reduce vision loss associated with diabetic retinopathy.   "
210445|NCT00604396|"     This trial is conducted in Europe.      The aim of this trial is to investigate the safety and efficacy of insulin detemir combined     with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic     drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose     control.   "
210446|NCT00604409|"     This trial is testing the safety of combining the oral chemotherapy drug capecitabine with     radio-labeled microspheres injected directly into the liver.   "
210447|NCT00604422|"     To evaluate the ability of the PillCam® Colon Capsule Endoscope to detect and classify     Ulcerative colitis   "
210448|NCT00604435|"     This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and     epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer     patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy     to chemotherapy could further enhance the cytotoxic activity in breast cancer.   "
210449|NCT00604448|"     In 2004, almost 60% of adult Canadians were overweight or obese. This is a serious health     concern due to the burden of common health risks associated with being overweight and obese,     including increased blood sugar, blood lipids and blood pressure. Together these risks are     known as metabolic syndrome. Obesity, the most common nutrition problem in Canada, can in     many cases be treated through changes in our diet (what we eat and/or how much we eat).     Pulses (beans, chickpeas, lentils and peas) when eaten on a regular basis may result in     decreased health risks associated with being overweight and obese. The purpose of this study     is to find out whether eating pulses (5 cups per week) results in improvements in metabolic     syndrome risk factors. We also want to determine whether the consumption of pulses alters the     levels of satiety hormones (hormones that make us feel hungry or full) in the blood. This     study will have 50 participants.   "
210450|NCT00604461|"     The purpose of this research study was to evaluate how effective the combination of     Carboplatin, Bevacizumab (Avastin™) and, Pemetrexed (Alimta™) is in the treatment of patients     with Malignant Pleural Mesothelioma (MPM). A combination of cisplatin and pemetrexed is     considered standard for this disease and typically off protocol patients would receive     cisplatin or carboplatin and pemetrexed as standard of care.      The planned length of the study (first patient screened to last patient enrolled) was 24     months. The planned length of the entire study (enrollment period + the treatment period + a     follow-up period of at least 12 months) was 36 months.   "
210451|NCT00604474|"     The primary objective to this study is to describe the auditory development and performance     of young deaf children who receive bilateral implants during the first two years following     device activation.   "
210452|NCT00604487|"     Artificial ripening of the cervix and induction of labor remain as one of the therapeutic     challenges in Obstetrics. The method widely used, the intravenous administration of Oxytocin,     is associated with prolonged induction periods, a significant failure rate, and considerable     patient discomfort. Therefore, over the years, a variety of locally applied pharmacological     and physical ripening agents were evaluated. Currently, the commonly utilised local ripening     agent is a Prostaglandin (PG) preparation. Although PG is being applied vaginally or     extra-amniotically, systemic absorption of this agent is common, sometimes resulting in     uterine hypertonicity, nausea and vomiting. In addition, both induction methods are     associated with the initiation of uterine contractions, sometimes lasting for prolonged     periods. Therefore a preferred induction method may be a mechanical one which will lead to     cervical ripening without causing uterine contractions. Furthermore, there are additional     potential advantages of mechanical methods compared to pharmacologic methods such as, ease of     storage, low cost and less side effects. A folly catheter, inserted through the cervix,     combined with continuous extra-amniotic NS instillation is being used for this purpose for     many years. However this method although effective may cause uncomfortable traction of the     balloon to the women's leg. Furthermore, dripping of saline through the cervix and vagina,     occasionally occurs, may be annoying, and may be confused with rupture of membrane. We have     recently introduced a newly developed balloon device (Atad Ripener Device), which was     designed with one balloon located at the distal end of the device (the uterine balloon, U),     while the other balloon is located 1.5 cm proximal to the first one (the cervicovaginal     balloon, CV). Both balloons are expandable with Saline. The balloon inflated in the vagina     provides the traction action and seals the cervix from saline leakage. Another balloon the     AID (Atad double balloon Instillation Device) is identical to the ARD but has an additional     long tip for instillation of normal to the extra-amniotic space. To the best of our     knowledge, no comparison was performed between the use of the double balloon ripener device     and folly catheter for induction of labor. Furthermore, there are no published data regarding     the use of the double balloon instillation device (AID) combined with continuous     extra-amniotic NS instillation. This study is designed to compare the efficacy, safety and     side effects of mechanical methods of cervical ripening and labor induction by the double     balloon device (ARD), the double balloon instillation device (AID) combined with continuous     extra-amniotic instillation of normal saline and the folly catheter combined with continuous     extra-amniotic normal saline instillation. The study aims at the accrual of 300 women (100     randomised in each arm).   "
210455|NCT00604526|"     High dose rate (HDR) brachytherapy is a form of radiation treatment using temporary     radioactive seeds. This is done by placing very tiny catheters or tubes into the prostate and     then inserting temporary radioactive seeds, called Iridium 192, through these catheters. HDR     brachytherapy gives precise radiation to the prostate with less radiation given to the normal     tissues near the prostate. For patients who have been treated with external beam radiation to     the prostate before, HDR brachytherapy can give radiation again to the prostate without     exposing the normal tissues around the prostate to significantly more radiation. This may be     safer than giving external beam radiation again. The purpose of this study is to test the     safety of high dose rate temporary brachytherapy (HDR) for prostate cancer that has come back     after external beam radiation. We want to find out what effects, good and/or bad, the     treatment has on you and your recurrent prostate cancer.   "
246224|NCT01086436|"     The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy     children aged 2 to 6 years in China.   "
210459|NCT00604578|"     This study will test whether pioglitazone hydrochloride (Actos (Registered Trademark)     Registered Trademark) is effective for treating patients with asthma who do not respond to     standard therapy. Experiments have shown that this drug, which is used to treat patients with     diabetes, may be effective for treating asthma.      People between 18 and 75 years of age who have had asthma for at least a1 year and whose     symptoms are not well controlled with high doses of inhaled corticosteroids with or without     long-acting bronchodilators may be eligible for this study. Candidates are screened with     breathing tests, an allergy skin test, chest x-ray, electrocardiogram (ECG), echocardiogram     (ultrasound test of the heart), blood tests, and DEXA scan (an x-ray to measure bone     thickness) to make sure they are eligible for the study.      Then, participants undergo tests and procedures in the following study phases:      Phase 1      Participants are given a device to measure and record their lung function and asthma symptoms     at home each morning and night for 4 weeks before starting the study medication. Lung     function is also measured at clinic visits before and after inhaling a bronchodilator     medicine. Before starting the study medication, participants have a sputum induction (sputum     collection test). For this test, the participants inhale a salt-water mist and are asked to     collect sputum into a plastic cup.      Phase II      Participants are randomly selected to receive either pioglitazone hydrochloride or placebo (a     look-alike pill with no active ingredient) once a day for 10 weeks. They return to the clinic     after 2 weeks to repeat the tests done in Phase 1 and to monitor any reactions to the study     drug or placebo. If there are no problems, the amount of medication is increased once, and     then they return for follow-up evaluations every 2 weeks for 8 weeks. Pulmonary function     tests, sputum collection and DEXA scan are repeated after 10 weeks on medication.      Phase III      Patients return for follow-up 1 month after stopping the medication or placebo to monitor     their asthma.   "
210460|NCT00604591|"     This study will test the effects of a medication called tolcapone on cognitive, behavioral,     and language problems seen in patients with frontotemporal dementia (FTD). Tolcapone     increases the amount of dopamine, a brain chemical that may be lowered in FTD. The study will     see if tolcapone can improve thinking, behavior, and language in people with FTD and will     look at the effects of the drug on brain activity.      Patients with FTD who are between 40 and 85 years of age may be eligible for this study.      Participants will be seen as outpatients at the Columbia University Medical Center     approximately one a week for 4 weeks. They take tolcapone or a placebo (a look-alike pill     with no active ingredient) during study week 1. During study week 3, those who took placebo     during week 1 now take tolcapone for 1 week and those who took tolcapone now take placebo. In     addition, patients undergo the following tests and procedures:        -  Neurological tests to evaluate attention, problem-solving and memory. These tests are          repeated several times during the course of the study.        -  Test to look for a gene that affects the amount of dopamine in the brain, using blood          samples collected in a previous study.        -  Blood draws four times during the study.        -  Functional MRI (fMRI) to learn about changes in brain regions that are involved in          performing tasks. For fMRI, the patient lies on a table that can slide in and out of the          scanner, a narrow metal cylinder surrounded by a magnetic field. The procedure takes          about 60 minutes and is performed four times over the course of the . FMRI involves          taking pictures of the brain during MRI while the subject performs a task so that          changes in the brain that occur during these tasks can be studied.   "
210461|NCT00604604|"     The primary objective of this study is to evaluate the effect of peer (mother-to-mother)     support on the prevention of postpartum depression among mothers identified as high-risk.   "
210462|NCT00604617|"     Tuberculosis (TB) is a disease affecting the lungs that is caused by a germ spread by     coughing. TB infection is currently diagnosed by a skin test that has limited accuracy. The     purpose of this study is to look at the reliability of a new blood test for diagnosing TB     infection in children. Study participants will include 300 HIV-infected (HIV infection is a     viral infection that causes disease which destroys the body's ability to protect itself from     infection and disease.) children and 500 HIV-uninfected children, ages 3 months to 5 years,     residing in the Khayelitsha and Ravensmead/Uitsig Communities of the Western Cape Province,     South Africa. Study procedures will include questionnaires, HIV and TB testing, which will be     performed by blood and skin tests. Participants may be involved in study related procedures     for up to 24 months.   "
210463|NCT00604630|"     The purpose of this randomized, double-blind, placebo-controlled multicenter study is to     determine in a cohort of 506 patients with acute ischemic stroke in the middle cerebral     artery territory, the effect of a three-day high-dose, intravenous erythropoietin treatment     on functional outcome up to a follow-up of 90 days.   "
210464|NCT00604643|"     An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who     have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for     treatment with an AneuRx Aortic Cuff.   "
210465|NCT00604656|"     This trial is conducted in Europe. The aim of this trial is to investigate the safety and     efficacy of insulin aspart produced by current process compared to that of insulin aspart     produced by NN2000 process in subjects with type 2 diabetes.   "
210466|NCT00604669|"     A growing body of evidence suggests hyperglycemia is associated with adverse outcomes in     patients with and without diabetes. Observational studies document an association between     hyperglycemia and poor clinical outcomes in cardiothoracic surgery, elective surgery,     myocardial infarction, stroke. Randomized studies indicate glycemic control is associated     with improved outcomes in diabetic patients with critically illness. Hyperglycemia is a     recognized and common complication of patients receiving total parenteral nutrition (TPN).     Few studies in the literature have looked into the impact of TPN-associated inhospital     complications and mortality. Accordingly, this study aims to evaluate the impact of     hyperglycemia on clinical outcome (infections, systemic sepsis, cardiac complications, acute     renal failure, length of stay, and mortality) in patients receiving TPN. We will perform a     retrospective chart review of all patients treated with TPN from 1/01/06 to 12/31/06 at Grady     Memorial Hospital. We hypothesize that patients receiving TPN who develop hyperglycemia     experience higher morbidity (infections, systemic sepsis, cardiac complications, acute renal     failure, length of stay) and mortality compared to TPN patients with euglycemia. The results     of this study will help us to formulate a prospective randomized clinical trial on the     management of TPN-associated hyperglycemia in hospitalized patients.      This study aims to evaluate the impact of hyperglycemia on clinical outcome (infections,     systemic sepsis, cardiac complications, acute renal failure, length of stay, in hospital     mortality) in patients receiving total parenteral nutrition. We will perform a retrospective     chart review of all patients admitted to the hospital receiving TPN from 1/01/06 to 12/31/06     at Grady Memorial Hospital. The results of this study will help us to formulate a prospective     randomized clinical trial on the management of TPN-associated hyperglycemia in hospitalized     patients.   "
210467|NCT00604682|"     Open label study for patients with severe plaque type psoriasis. This study is looking to     evaluate the pharmacodynamic effect of CC10004 when taken for 29 days in reducing the     epidermal thickness in subjects with severe placque type psoriasis.   "
210468|NCT00604695|"     The primary objective of this study is to gather preliminary data regarding the angiographic     efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during     balloon angioplasty for heart attacks.      We hypothesize that low-dose IC tenecteplase will enhance the breakdown of blood clots at the     site of the culprit lesion leading to reduced damage to the heart muscle.   "
210469|NCT00604708|"     The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51     compared to JE-VAX in healthy subjects aged > or = 18 years   "
210470|NCT00604721|"     This phase II trial is studying selumetinib to see how well it works in treating patients     with locally advanced or metastatic liver cancer. Selumetinib may stop the growth of tumor     cells by blocking some of the enzymes needed for their growth.   "
210472|NCT00604747|"     Background: The literature indicates that, in relation to motor learning, healthy subjects     benefit more from random practice than from constant practice. However, this effect is not     well known in post-stroke patients. Objective: The goal of this study was to investigate the     effects of practice structure on motor learning in post-stroke patients. Methods:     Participants included an experimental group (EG) of post-stroke patients: 17 males and     females; and a control group (CG) of healthy individuals: 17 males and females. At the     acquisition phase, all participants performed 30 trials of a coincident timing task. Nine     individuals from each group practiced constantly (C) at a stimulus propagation speed of 3     mph, and eight from each group practiced randomly (R) at speeds of 2, 3, and 5 mph.     Subsequent phases included: 1) transfer, 2) retention after 15 minutes, and 3) retention     after 3 days. Each of these phases included 20 trials: 10 at a speed of 1 mph, and 10 at a     speed of 4 mph. Intra- and inter-group comparisons were made employing an alpha level of 0.05     (5%).   "
210473|NCT00604760|"     To establish the proof of concept that MEM 3454, used as add-on pharmacotherapy, is a safe     and effective treatment in patients with cognitive impairment associated with schizophrenia     (CIAS).   "
210474|NCT00604773|"     The objective of this study is to determine the incidence of delirium in adults patients who     are admitted at the critical care unit of a Dutch University Hospital.      The primary aim is to determine the incidence of delirium and to determine risk factors for     this group of patients to develop a prediction model.      A secondary aim is to find differences between delirious patients and non-delirious patients     on different aspects of diagnostics, treatment and care, outcome, length of stay, and     inflammation.      According to Dutch law, the need to obtain informed consent was waived by the Committee on     Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).   "
210475|NCT00604786|"     This research is being done to study the effects of the drug omalizumab (Xolair) in people     with cat allergies. The investigators will use omalizumab to study changes in the cells in     the nose, skin and blood that cause allergies. The investigators predict that cells in the     blood will be effected before cells in the nose or skin.   "
210476|NCT00604799|"     A Descending Thoracic Aneurysm is a bulge in the aorta. The aorta is a large blood vessel     that carries blood away from your heart to organs in the rest of your body. Your aneurysm is     caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow     larger and may ultimately rupture (break open) or extend in size to seriously affect other     major arteries in the area. In this Research Study a device will be placed inside your aorta     to block the weakened part of the artery wall from the circulatory system. Information will     be collected on the performance for the device for 5 years.   "
210477|NCT00604812|"     A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed     drug in pediatric subjects with migraines.      After completion of a portion of the study (Panels A and B), a regulatory agency issued an     amended request that the 12-17 year old age group studied should include a similar number of     male and female subjects. Therefore, the study was amended to add an additional panel of     subjects (Panel C) to ensure gender balance specifically in this age group.   "
210478|NCT00604825|"     The purpose of this study is to determine whether GSK232802 is safe and effective in reducing     the frequency and severity of hot flashes associated with menopause.   "
210479|NCT00604838|"     The purpose of this study is to demonstrate that the Diagnostic Absorbent Panty liner     (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd., can distinguish between     wetness sensed by pregnant women that is caused by amniotic fluid leakage and that which is     caused by urinary incontinence.   "
210524|NCT00605423|"     Treatment of exudative age-related macular degeneration has been significantly improved by     the advent of Lucentis™( which provides improved vision rather than simply stabilization) is     common; however, monthly injections may be required to maintain this effect. It is     hypothesized that sustained release fluocinolone acetonide will allow maintenance of the     improved vision with fewer Lucentis injections.   "
210552|NCT00605826|"     The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used     as an injectable bulking agent in the treatment of fecal incontinence. The study includes a     6-month blinded sham-controlled phase, followed by an open-label phase.   "
210480|NCT00604851|"     Gastroesophageal reflux (GER) is frequent in children with asthma, can induce bronchspasm,     and increase airway reactivity. Children with asthma are often treated for GER with drugs to     supress gastric acid production. However, this treatment is expensive, and with unproven     benefit. The primary objective of this study is to conduct a multi-site, randomized, clinical     trial to test the hypothesis that treatment of GER with lansoprazole, an approved proton pump     inhibitor, will decrease the frequency of exacerbations in children with poorly controlled     asthma. The study will include 300 asthmatic children treated with inhaled corticosteroids,     6-16 years of age, with poor control defined by frequent symptoms, excessive beta agonist     use, or frequent exacerbations. Participants will be randomly assigned to treatment with     either lansoprazole or placebo for 6 months. The presence, severity, and relationship of GER     to asthma symptoms will be determined with 24 hour esophageal pH monitoring, but     randomization to treatment will not be influenced by the presence or severity of GER. The     primary outcome measure is the proportion of participants who have exacerbations of asthma     defined by diaries and interviews. Secondary outcome measures include asthma symptom and     control scores, GER symptoms, lung function, and unscheduled health care contacts.     Pre-defined subgroup analyses will examine the relationship between specific clinical     features and the response to lansoprazole. Treatment response will also be evaluated with     3-hour post-dose plasma lansoprazole concentrations, and related to polymorphisms in the gene     CYP2C19, the cytochrome P450 pathway, and interleukin-1 (IL-1) beta, a pro-inflammatory     cytokine. Tertiary studies will determine how the magnitude of GER impacts airways     inflammation, as measured by the concentrations of hydrogen ions (pH) and nitric oxide in     expired breath. The results of this trial sould have a major impact on the understanding and     treatment of GER in children with asthma.   "
210481|NCT00604864|"     Deep endometriosis associated pain is believed to be caused by inflammation. Anti TNFa has     been proved to be an effective treatment for other inflammation related conditions as Crohn's     disease Endometriosis is associated with an inflammatory response in the pelvis, which is     mediated by a number of cytokines including TNF-α. It has therefore been suggested that     infliximab, an anti-TNF-α monoclonal antibody, might relieve pain in affected women.   "
210482|NCT00604877|"     This study examines the hypothesis that 6 months of treadmill aerobic exercise training     improves fibrinolysis (clot defense mechanism) and vasomotor function in chronic hemiparetic     (muscular weakness or partial paralysis restricted to one side of the body) stroke patients     compared to a control intervention, and that these changes are associated with reduced plasma     insulin levels and improved insulin sensitivity / glucose metabolism in this population.   "
210483|NCT00604890|"     The purpose of this study is to determine the safety and tolerability of pharmaceutical     compound (API 31510) topical cream topically applied to superficial basal cell carcinomas to     obtain preliminary efficacy data for the treatment of superficial basal cell carcinomas by     API 31510 topical cream. The study population will include one hundred and sixty (160)     otherwise healthy male or female adults with one or more histologically confirmed superficial     basal cell carcinoma lesions. One target lesion with an area of less than one inch will be     designated for study treatment.   "
210484|NCT00604903|"     The purpose of this study is to evaluate and document appropriate clinical safety and     performance of the Remon CHF Implantable Pressure Sensor including the corresponding delivery     system, the Remon CHF Home Unit, the Remon CHF Clinic System devices and associated     application software. It is a small clinical trial to determine the feasibility of the     device. The primary outcome measure relates to feasibility and not to health outcomes.   "
210485|NCT00604916|"     The Nosocomial Pneumonia remains to be a major complication for patients who were incubated     with ventilation. Most cases are attributed to increased bacteria flora in oropharyngeal     secretion and aspiration of those organisms. Research indicates that the Gram-Negative     Bacteria grows in upper air way and trachea rapidly during the initial 2-4 hospital days and     the dental plague also increased dramatically at the first 5 days. About 50% cases with     prolonged intubation experienced temporal swallowing disorders and majority of them recovered     7 days post weaning. Some evidence exist suggesting that oral care could reduce bacterial     flora, prevent aspiration, and subsequently decrease the incidence of ventilation-associated     pneumonia for this group of high risk patients.      This study aims to evaluate the effectiveness of a standardized oral care protocol in     improving oral hygiene and reducing the incidence of pneumonia on a sample of surgical     patients at intensive care unit.   "
210486|NCT00604929|"     The present proposal is designed to examine the effect of carbohydrate and protein     co-ingestion on muscle protein synthesis during endurance type exercise activities. We     hypothesize that muscle protein synthesis is higher when protein is co-ingested during     exercise.   "
210487|NCT00604942|"     Recent work at St. Thomas' has validated an innovative new design of a multichannel     intraluminal impedance (MII) catheter that is sensitive to variation in oesophageal volume in     healthy volunteers and patients. This project will establish the clinical value of volume     sensitive MII (vMII) compared to conventional MII acquired simultaneously by the same     catheter (ROC analysis). Studies will assess:        1. The accuracy of volume measurements and correlation between symptoms and the volume of          bolus retention in patients with dysphagia.        2. The accuracy of volume measurements and correlation between symptoms and reflux volume          in patients with reflux disease.      Follow up studies after appropriate treatment will assess whether symptomatic improvement is     associated with a reduction in oesophageal volume retention/reflux.      The vMII technique will be applied with high resolution manometry (HRM). These investigations     are complementary in that vMII assesses the success or failure of bolus transport (or     occurrence of reflux) and HRM can assess:        1. the oesophageal dysfunction that results in bolus escape        2. the abnormal events at the gastro−oesophageal junction (reflux barrier) that allow          reflux to occur.      with a reduction in oesophageal volume retention / reflux.   "
210488|NCT00604955|"     This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection     when given to an expanded population in the outpatient setting in experienced VL centers and     subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin     IM Injection to progressively more resource-constrained clinics in Bihar, India.   "
210489|NCT00604968|"     The purpose of this study is to evaluate the safety and efficacy of pegylated liposomal     doxorubicin (Caelyx) in elderly patients who are to receive first-line chemotherapy for     metastatic or locally advanced breast cancer, not amenable to surgery.   "
210571|NCT00606073|"     The aim of this study is to examine whether incubation of human oocytes until pronuclear     stage, in different culture media containing high and low concentrations of glucose affect     fertilization differently, not only in standard IVF cycles, but also after intracytoplasmatic     sperm injection.In addition, we wish to determine whether exposure of oocytes to different     concentrations of glucose until pronuclear stage has further effect on embryo quality and     development until the blastocyst stage.   "
210490|NCT00604981|"     Despite the dramatic increase in obesity and Type II Diabetes in adolescents, documented     effective treatments for obesity and the consequential prevention of Type II Diabetes are     scarce. Modification of food and activity choices is the foundation of obesity treatment;     however, adolescents may find it difficult to follow recommended diet and exercise programs.     This study uses a home-based treatment, Multisystemic Therapy (MST), to target change within     the individual, family and environmental contexts. Participants are 49 obese (BMI>95th     percentile) African American adolescents (ages 12-17). 24 were randomized to receive the MST     intervention and 25 were placed in Shapedown, a family group program. Families were recruited     from the only university-affiliated medical center in Detroit, Michigan. Michigan's youth     have higher rates of obesity, overweight, hypertension, and elevated cholesterol compared to     the national average, and Detroit has the highest percentage of African Americans of any     major city in the US. Families complete measurements at the start of the treatment, at the     end of the treatment and one year after enrollment. We expect to find that youth in the MST     group will show more weight loss and greater improvements in diet (e.g., caloric intake and     exercise behaviors than will youth in Shapedown. These changes in food choices, activity     levels, and weight are expected to remain after the end of treatment. This intervention is     intended to provide immediate assistance to a vulnerable population disproportionately     affected by obesity and its long-term health complications.   "
210491|NCT00604994|"     This project will conduct a prospective, longitudinal, observational cohort study to assess     the onset and incidence of lymphoedema, as well as investigate factors associated with its     development among women newly diagnosed with gynaecological cancers in 2008 to 2011.   "
210513|NCT00605280|"     The purpose of the study is to test whether Macugen injected into the eye improves vision in     more patients than the currently existing standard of care laser therapy. The safety of     Macugen compared to standard of care laser will also be evaluated.   "
210658|NCT00600379|"     The purpose of this study is to examine the feasibility and efficacy of a virtual reality     program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.   "
210492|NCT00605007|"     Hyperglycemia is a common complication of corticosteroid (cortisone) therapy. It is estimated     that more than a third of patients with chronic pulmonary disease (COPD) exacerbation (16).     Despite its frequency, the impact of corticosteroid-induced diabetes on clinical outcome and     mortality is not known. A computerized search of biomedical journal literature from MEDLINE,     PubMed, and Ovid from 1966 to 2006 provided very little information on the prevalence and     outcome of corticosteroid-induced diabetes in patients with COPD. Therefore, the present     study aims to evaluate the impact of corticosteroid-induced diabetes on clinical outcome in     patients with COPD exacerbation. We will perform a retrospective chart review of all patients     admitted to the hospital with COPD exacerbation from 1/01/05 to 06/30/06 at Grady Memorial     Hospital. Medical records of all patients with COPD exacerbation treated with corticosteroids     will be analyzed. Data on demographics, laboratory values, mortality rate, rate of     hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.   "
210493|NCT00605020|"     This trial is conducted in Europe.      The aim of this trial is to investigate the efficacy and safety of an intensified treatment     regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more     convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in     subjects with type 2 diabetes.   "
210494|NCT00605033|"     Post-marketing commitment to the European Medicines Agency to conduct a prospective,     controlled study of the transfer from Subutex to Suboxone.   "
210495|NCT00605046|"     Purpose:      The main objectives of this proposal are as follows:      To assess the dynamic uptake and washout of 123-I AV151, a potential imaging biomarker for     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in     similarly aged healthy controls and Alzheimer's (AD) subjects      To perform blood metabolite characterization of 123-I AV151 in healthy and AD subjects to     determine the metabolic fate and nature of metabolites in assessment of 123-I AV151 as a     single photon computed tomography (SPECT) brain imaging agent      Evaluate the test/retest reproducibility of 123-I AV151 and SPECT in AD subjects and healthy     controls   "
210496|NCT00605059|"     The main objectives of this proposal are as follows:      To assess the dynamic uptake and washout of 123-I AV94, a potential imaging biomarker for     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in     similarly aged healthy controls and Alzheimer's (AD) subjects      To perform blood metabolite characterization of 123-I AV94 in healthy and AD subjects to     determine the metabolic fate and nature of metabolites in assessment of 123-I AV94 as a     single photon computed tomography (SPECT) brain imaging agent      Evaluate the test/retest reproducibility of 123-I AV94 and SPECT in AD subjects and healthy     controls   "
210497|NCT00605072|"     The purpose of this study is to examine the effects of blood pressure medications on     cognition and blood flow in hypertensive elderly patients with cognitive impairment. The     hypothesis is that treatment with an angiotensin receptor blocker (ARB) or an     angiotensin-converting enzyme inhibitor (ACEI) will be associated with a slower rate of     further cognitive decline, improved cerebral blood flow and its regulation, and preserved     physical function as compared to treatment with a diuretic (HCTZ), independent of blood     pressure level.   "
210498|NCT00605085|"     The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine     IC51 with an inactive control in healthy subjects aged > or = 18 years   "
210525|NCT00605436|"     We tested the following hypotheses:        1. That a standardized yoga therapy will improve insulin sensitivity (primary outcome), and          other features of the metabolic syndrome such as hypertension and dyslipidemia          (secondary outcomes), we will perform a 2-hour oral glucose tolerance test, fasting          blood tests, and a physical examination before and after randomization of subjects to a          10-week yoga therapy intervention or wait-list control group.        2. That a yoga therapy is feasible in overweight and underactive individuals with the          metabolic syndrome, that adherence to a yoga intervention is acceptable, and that yoga          therapy is associated with improved quality of life, we will assess the adherence to          twice-weekly yoga group sessions (for weeks1-5) and weekly yoga group sessions (for          weeks 6-10), frequency of home yoga therapy practice, and self-reported quality of life          before and after the intervention in both treatment groups.        3. To elucidate a potential mechanism for the effect of yoga on changes in insulin          resistance by evaluating markers of inflammation from adipose tissue (adipocytokines).          We hypothesize that these biochemical parameters will show modest improvement with yoga          therapy and that changes in these parameters will be associated with improvements in          insulin sensitivity.   "
213085|NCT00640432|"     To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with     acute low back pain   "
210499|NCT00605098|"     This is a multicenter, open, prospective and randomized study aimed at evaluating the     pharmacokinetics of the tablet formulation of lopinavir/r administered in combination with     two nucleoside analogs to HIV-infected pregnant women at two different dosages:        -  Group 1 (standard dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours, plus two          nucleoside analogs.        -  Group 2 (increased dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours until the          end of the second trimester of gestation (24 weeks) and 3 tablets every 12 hours in the          third trimester (from 25 weeks on), plus two nucleoside analogs.      Treatment will be initiated at any time between 14 and 30 weeks of gestation and will be     maintained for at least 6 weeks after delivery.      The objectives are:        -  To compare the pharmacokinetic parameters of the standard and increased dosage of the          tablet formulation of lopinavir/r during pregnancy.        -  To determine whether the standard and/or increased dosage of the tablet formulation of          lopinavir/r during pregnancy confers the same exposure to the drug as that observed in          the same women after the end of pregnancy and in historic controls.        -  To evaluate the transplacental passage of lopinavir/r based on the ratio between the          serum concentration in maternal blood at the time of delivery and in cord blood of the          two drug dosages (standard and increased) administered during pregnancy.        -  To evaluate the tolerability of the two lopinavir/r dosages (standard and increased)          during pregnancy.        -  To describe the vertical transmission rate of HIV to the children of the pregnant women          included in the study.   "
210500|NCT00605111|"     This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and     safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes     failing OAD therapy.   "
210501|NCT00605124|"     Total knee arthroplasty (TKA) is performed more than 7.000 times a year in Finland most often     for osteoarthritis (OA). While pain is predictably reduced, function does not typically ever     reach that of age-matched, uninjured subjects. Quadriceps weakness has been implicated in the     development and progression of knee OA and is a significant problem after TKA. Advance to     return to normal daily activities is not sufficient to restore knee function or quadriceps     strength after TKA.      The aim of this study is to assess the effectiveness of progressive exercise program     restoring knee strength, mobility and improving the functional outcome after primary TKA.   "
210502|NCT00605137|"     This trial is conducted in Japan. The aim of trial is to investigate the safety of insulin     detemir and insulin NPH in children with type 1 diabetes.   "
210503|NCT00605150|"     MDS Nordion's TheraSphere, Yttrium-90 glass microspheres has been approved as a Humanitarian     device authorized by federal(USA)law for use in radiation treatment or as a neoadjuvant to     surgery or transplantation in patients with unresectable hepatocellular carcinoma(HCC)who can     have placement of appropriately positioned hepatic arterial catheters. Outcomes of this     treatment protocol will be monitored and reported to the Carolinas HealthCare System     Institutional Review Board.   "
210504|NCT00605163|"     The purpose of this study is to longitudinally follow consenting clinical trial participants     who participated in PRECEPT (A Randomized, Double Blind, Placebo Controlled, Dose Finding     Study to Assess the Efficacy and Safety of CEP 1347 in Patients With Early Parkinson's     Disease). The study will assess the clinical and imaging outcomes relevant to the natural     history of Parkinson's disease (PD), as well as determine early biomarkers of the disease.   "
210505|NCT00605176|"     The purpose of this study is to determine whether imiquimod creams are effective in treating     Actinic Keratoses when applied to the face or balding scalp.      Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the     sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient     contained in the study cream for this study is the same as that of the approved product     Aldara, which has been shown to be safe and effective for the treatment of AKs.   "
210506|NCT00605189|"     A randomized, controlled pilot study examining how cellular energetics related to various     wound treatment therapies in patients with diabetic foot ulcers.   "
210507|NCT00605202|"     This clinical trial is designed to study the effect of the combination of licorice and     hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy     volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily     hydrochlorothiazide for 14 days. This combination is compared with 32 grams of licorice a day     for 14 days given in the other arm. The study is a randomized, open-label cross-over trial.     There is at least a 3-week wash-out between the arms. The hypothesis is that the combination     of licorice and hydrochlorothiazide will cause hypokalemia. The main outcome measure is the     change in the plasma level of potassium between the arms.   "
210508|NCT00605215|"     The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 mg     with the effect of placebo capsules (capsules that contain no active medication) as well as     with the effect of an existing MS injectable drug: Interferon β-1a (Avonex®).   "
210509|NCT00605228|"     Primary:      - To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to     colonoscopy.      Secondary:        -  To assess the safety of Moviprep® versus Colopeg®.        -  To assess acceptability of Moviprep® versus Colopeg®.   "
210510|NCT00605241|"     GSK598809 is being developed as an innovative treatment for substance dependence and     potentially other compulsive behavioral disorders. This study will asses the effects of a     single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male     volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or     GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of     at least seven days between each session.   "
210526|NCT00605449|"     This study is a 3-period crossover drug interaction study between GSK376501 and simvastatin     in healthy adult subjects. This study will examine if repeat doses of GSK376501 affects the     pharmacokinetics of simvastatin and if repeat doses of simvastatin affects the     pharmacokinetics of GSK375601.   "
210527|NCT00605475|"     The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether     Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose     levels in response to an oral glucose tolerance test (OGTT).   "
211182|NCT00607386|"     The objective of this study is to determine the safety of once weekly dosing of idursulfase     0.5 mg/kg administered by intravenous (IV) infusion for male Hunter syndrome patients ≤ 5     years old.   "
210511|NCT00605254|"     This study will test the use of a radioactive substance called [11C]dLop for measuring     P-glycoprotein (P-gp) using positron emission tomography (PET) imaging. The P-gp protein acts     as a pump in cells, affecting a variety of functions, such as limiting drug absorption and     elimination and decreasing drug penetration into certain tissues, such as the brain. It is a     major obstacle to successful chemotherapy because it can pump cancer drugs out of the cells,     interfering with treatment. Decreased P-gp function may contribute to disorders such as     Parkinson s disease and Alzheimer s disease, whereas higher levels of the protein have been     found in patients with epilepsy and in several forms of drug-resistant cancer tumors. This     study will determine uptake and clearance of [11C]dLop and the radiation exposure to organs     of the body to assess its possible use in further studies of P-gp function.      Healthy normal volunteers between 18 and 51 years of age may be eligible for this study.     Candidates are screened with a medical history, physical examination and blood and urine     tests.      Participants undergo the following procedures:        -  Electrocardiogram (ECG): A test of the electrical function of the heart.        -  Brain PET scans: PET imaging uses small amounts of a radioactive chemical called a          tracer that labels active areas of the brain so the activity can be seen with a special          camera. The tracer used in this study is [18F]FMPEP-d(2). Before starting the scan, a          catheter (plastic tube) is placed in a vein in the arm to inject the tracer and another          catheter is placed in an artery in the wrist to obtain blood samples during the scan.          For the procedure, the subject lies on the scanner bed. A special mask is fitted to the          head and attached to the bed to help keep the person s head still during the scan so the          images will be clear. A brief scan is done just before the tracer is injected to provide          measures of the brain that are helpful in calculating information from subsequent scans.          After the tracer is injected, pictures are taken for about 2.5 hours, while the subject          lies still on the scanner bed. Blood and urine tests are done after 24 hours after the          scan.        -  Magnetic resonance imaging (MRI): An MRI scan is done within 1 year (before or after) of          the PET scan. This procedure uses a magnetic field and radio waves to produce images of          the brain. The subject lies on a table that is moved into the scanner (a tube-like          device), wearing earplugs to muffle the noise of the machine during the scanning          process. The test takes about 1 hour....   "
210512|NCT00605267|"     The purpose of this multi-centre, randomised, double-blind, parallel-group study is to     compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative     administration under goserelin acetate treatment for premenopausal breast cancer patients   "
210514|NCT00605293|"     This 2 arm study will compare the efficacy and safety of monthly administration of     intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in     hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance     treatment with epoetin alfa will be randomized either to receive monthly injections of 120,     200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa     they were receiving in the week preceding study start, or to continue on epoetin alfa     treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146     participants.   "
210515|NCT00605306|"     This study will investigate the safety and tolerability of indacaterol maleate/mometasone     furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate     asthma.   "
210516|NCT00605319|"     The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency     with or without the inability to hold your urine until you get to the toilet) are invited to     participate in this research study. Overactive bladder is a common sequelae of long-term     bladder outlet obstruction in men. Unfortunately, it does not often resolve after treatment     of the obstruction (transurethral resection of the prostate). These patients are usually     started empirically on alpha-blockers or occasionally anticholinergic agents, former used to     treat enlarged prostate medically, and latter, to treat overactive bladder. We hypothesize     that these patients would be significantly improved with a long-acting anticholinergic agent     such as long acting Fesoterodine or Toviaz.      Earlier studies have shown that anticholinergic drugs seem to have a beneficial effect on     symptoms of patients with bladder outlet obstruction and overactive bladder. In addition,     anticholinergic drug Toviaz is not associated with increased incidence of complication like     acute urinary retention, a state where patient is unable to empty the bladder as an adverse     effect of the drug.      A large proportion of our patients that are undergoing treatment for bladder outlet     obstruction also have overactive bladder. We propose an open label trial to evaluate the     efficacy of Toviaz (fesoterodine) 4mg to 8 mg in patients that have continued symptoms of     overactive bladder one month following transurethral resection of the prostate. Toviaz is an     antimuscarinic and anticholinergic agent, and is a newer formulation of Detrol. Patients with     overactive bladder on urodynamic test preoperatively will be considered. If these patients     continue to have symptoms at the one-month post-operative visit, they will be enrolled into     the study. We expect a total of 25 patients to be enrolled within 4 months. All patients will     receive Toviaz 4mg to 8 mg. The patients will be followed at 3 months post-op, 4 months     post-op, and 7 months post-op. At each post-op visit, the patients will fill out an AUA     symptom score questionnaire, have noninvasive uroflowmetry performed, and have a post-void     residual measured by bladder scan. Using standard statistical analysis, we will see if there     is a difference in symptoms, post-void residual, or maximum flow rate between baseline and 7     months post-op. We will continue the study to evaluate long-term efficacy, dropout rate, and     complications. An FDA approved flexible dosing regimen will be allowed for the duration of     the study.   "
210517|NCT00605332|"     This is an open label, non-randomized, prospective, multicenter study.   "
210518|NCT00605345|"     This two arm study will compare the efficacy and safety of subcutaneous Mircera versus     darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients     with chronic renal anemia. Patients currently receiving maintenance treatment with     darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a     starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of     darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on     2-weekly darbepoetin alfa therapy. The anticipated time on study treatment is 3-12 months,     and the target sample size is 100-500 individuals.   "
210519|NCT00605358|"     The purpose of this study is to test the effectiveness of Open Door (previously known as the     Treatment Initiation Program [TIP]), a brief psychosocial intervention to address the     psychological barriers to care and improve the use of mental health services by depressed     community elderly. The intervention is designed to help the older adult identify the     barriers, problem-solve to find solutions and mobilize the motivation to seek help. Open Door     was developed to work collaboratively with an older adult who is depressed to improve access     and adherence to mental health treatment.   "
210520|NCT00605371|"     This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine     XR in healthy male and female volunteers   "
210521|NCT00605384|"     The purpose of this clinical research study is to find out whether a combination of entecavir     (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added     to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant     against lamivudine. The safety of this treatment will also be studied.   "
210528|NCT00605488|"     See where the dye-like material (FACBC) goes in your body and how long it stays in your body.     See how much of the dye-like material is picked up by your tumor Compare the FACBC pictures     with other pictures (such as FDG PET scan) that were obtained as part of your standard     imaging evaluation.   "
211713|NCT00615030|"     This study was conducted to provide detailed information on the efficacy of indacaterol (in     terms of the spirometry assessment forced expiratory volume in 1 second [FEV1]) over the full     24-h time period   "
210529|NCT00605514|"     This study will determine if experimental vaccines to prevent Ebola virus infection and     Marburg virus infection are safe and what side effects, if any, they cause. Ebola virus     infection may range from mild to severe, and may cause breathing problems, severe bleeding,     kidney problems and shock that can lead to death. Marburg virus infection causes an illness     similar to that caused by the Ebola virus. The vaccines used in this study contain genetic     material produced in the laboratory that causes the body to make a small amount of either     Ebola or Marburg virus proteins. No Ebola or Marburg virus is in the vaccines.      Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.      Participants are assigned to receive injections of either the Marburg or the Ebola vaccine.     The first group of participants will receive the Marburg vaccine and the second group will     receive the Ebola vaccine. The injections are given at 4-week intervals (study weeks 0, 4 and     8). They are given into a muscle with a needleless system called the Biojector(Registered     Trademark) 2000.      Participants keep a diary at home (on paper or electronically) for 5 days, in which they     record their temperature, symptoms and any reaction at the injection site. They call a study     nurse the day after vaccination to report how they feel and return to the clinic for     follow-up 2 weeks after each injection (weeks 2, 6 and 10). The visits include a check of     vital signs, blood and urine tests, medical history and review of medications taken.     Additional visits at weeks 12, 24 and 32 include a check of vital signs, medical history and     blood tests.   "
210530|NCT00605527|"     Acute lung injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) is a severe lung condition     that causes respiratory failure. This study will examine if differences in genes and     biomarkers involved in the blood clotting process may affect the severity of and recovery     from ALI/ARDS in children hospitalized with the condition.   "
210531|NCT00605540|"     The study aim is to verify the association between the changes in markers of disease and     patient´s prognosis in chronic obstructive pulmonary disease.   "
210533|NCT00605566|"     This is a phase II clinical trial to assess the efficacy of the combination of metronomic     cyclophosphamide and tailored sorafenib dosing in advanced, progressive NET. NET are highly     vascular tumors, and high VEGF expression has been correlated with worse clinical and     pathological characteristics as well as poor prognosis. A novel antiangiogenic approach     relies on targeting not only the endothelial cells but also rendering them more sensitive to     VEGFR blockade by achieving pericyte detachment. In this study, the dose of sorafenib will be     titrated up to a maximum of 800mg BID based on patients' toxicity and on a novel     pharmacodynamic assay that measures inhibition of molecular target(PDGFR) in patients'     peripheral blood mononuclear cells. Dual VEGFR targeting is achieved by administering     sorafenib plus metronomic low dose cyclophosphamide.   "
210534|NCT00605592|"     This protocol will provide islet cell transplantation to two separate populations in need of     a pancreas transplant:      Group I: Islet Cell Transplantation in Type I Diabetics without Kidney Problems      Group II: Islet Cell Transplantation in Type I Diabetics Who Have a Stable Functioning Kidney     Transplant      The targeted patients have very brittle diabetes or dangerous hypoglycemic unawareness and     may benefit from transplantation over continuing insulin therapy, even though chronic     immunosuppression is required. We believe that in these patients, the islet transplant     procedure promises enough potential benefit to justify subjecting patients who have not     previously had a transplant to the risk of immunosuppression.      In patients who are already subject to the dangers of chronic immunosuppression for other     reasons, i.e. to prevent rejection of a kidney allograft, the islet transplantation procedure     itself is the principal additional risk and this risk should be minimal. In these patients     (our Group II), the potential benefit from improved glycemic control is that it promises to     slow or even reverse diabetic complications, such as vascular problems leading to kidney     damage. It is this rationale that has made pancreas transplantation a widely accepted option     in patients with renal failure, despite the risks associated with whole pancreas     transplantation. Islet cell transplantation aims to provide a potentially lower risk     procedure that has similar relief from diabetic complications.   "
210535|NCT00605605|"     To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular     protection effect on heavy smokers.   "
210536|NCT00605618|"     Part A: The purpose of this study is to find the maximum tolerated dose of BMS-777607 in     subjects with advanced or metastatic solid tumors      Part B: The purpose of this study is to describe the preliminary activity of BMS-77607 in     subjects with advanced or metastatic gastroesophageal cancer, hormone refractory prostate     cancer, head and neck squamous cell carcinoma, and type I papillary renal cell carcinoma   "
210537|NCT00605631|"     This study is designed to evaluate the effect of pacing on post-MI patients.   "
210538|NCT00605644|"     The primary purpose of this study is to evaluate the safety and dose-response relationship of     N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects     administered MOA-728 who have chronic pain that is not due to cancer, and who have     opioid-induced bowel dysfunction (OIBD).   "
210550|NCT00605800|"     The results of this study may or may not establish useful baseline data, which will help us     understand how bone marrow derived adult liver stem cells behave in normal healthy     adults/volunteers (the control group), and in patients undergoing liver surgery. The bone     marrow is located within your bones and is the organ which is responsible to produce blood     cells and stem cells. Bone marrow derived adult liver stem cells are normal cells in your     bone marrow. These liver stem cells have the capacity to regenerate or in other words to     rebuild the liver after liver surgery, a process called liver regeneration. These cells are     very important for the liver to regrow its tissue after liver surgery. These cells are     thought to be activated in times of need by the liver.      Situations like liver surgery are one of these occasions when the liver will need the extra     help from these stem cells.      The results of this study will establish the baseline data necessary for the understanding of     how to harness the ability of these stem cells in times of liver surgery. Improvements in the     ability of the liver to regrow after surgery is thought to decrease complications related to     liver surgery. Harnessing this unique ability of stem cells may be utilized in the future to     enhance the regrowing process of liver tissue after liver surgery, called liver regeneration.   "
210539|NCT00605657|"     This study will test whether valproic acid (Depakote[Registered Trademark]) can shrink     enlarged lymph glands and spleen in patients with autoimmune lymphoproliferative syndrome     (ALPS). Depakote has been used for more than 30 years for treating various medical disorders     in adults and children, including migraine headaches, seizures and psychiatric disorders. In     animal studies, it was effective in shrinking both lymph nodes and spleen in animals with     conditions similar to ALPS.      People with ALPS who are between 2 and 70 years of age and who have had an enlarged spleen or     lymph glands for at least 1 year may be eligible for this study.      Participants take Depakote as a tablet or liquid or sprinkled on food twice a day for 16     weeks. The drug dose is increased slowly over the first 3 to 4 weeks until the maximum     tolerated dose is reached. Blood tests are done at 2, 4, 6, 8 and 10 weeks after starting the     drug and 1 week after the drug is stopped to check for treatment side effects. Valproic acid     blood levels will be checked during drug escalation, half way through therapy, and just     before the end of treatment. A physical examination and CT scan (or ultrasound of the abdomen     for patients who cannot undergo CT) are done before starting treatment and at the end of the     16-week treatment period to evaluate the response to treatment.      Patients who tolerate the treatment well and show shrinkage of the lymph glands or spleen may     be offered extended treatment for up to 1 year in consultation with their primary physician.     During the extended treatment period, blood tests are done at home every 6 to 8 weeks to     monitor for drug side effects. Follow up evaluation visits are scheduled at the NIH Clinical     Center every 3 months during the extended treatment period and 3, 6, and 12 months after     treatment has ended.   "
210540|NCT00605670|"     The goal of this study is to develop a questionnaire to measure patient satisfaction with     their breast surgery. This questionnaire will help surgeons better understand how patients     feel about their surgical results. We hope that such a questionnaire will improve the     understanding of breast surgery results and patient care.   "
210661|NCT00600418|"     The project is aimed at identifying children who are suffering from posttraumatic distress     and increasing capacity to provide treatment for them and for their caretakers. The project     will be implemented in 3 cities in Israel, Haifa, Kiryat Shmona and Sderot, exposed to     terrorism and the effects of war   "
210541|NCT00605683|"     Parkinson's disease is a major neurodegenerative disorder in which there is a progressive     loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of     dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a     precursor of DA that crosses the blood brain barrier, and also to the use of selective     inhibitors of MAO B, the major DA metabolising enzyme in man.      This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi     national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.)     versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects     with early idiopathic Parkinson's Disease.      The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score     from baseline to endpoint, was chosen based on regulatory guidance and prior use in other     trials in similar populations.   "
210542|NCT00605696|"     Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) is a severe lung condition     that causes respiratory failure. Symptoms usually develop within 24 to 48 hours of an     original injury or illness, and people with ALI/ARDS typically require care in the intensive     care unit (ICU). Little is known about how to prevent the onset of ALI/ARDS. The purpose of     this study is to examine if early infusions of insulin, known as intensive insulin therapy     (IIT), can help prevent ALI/ARDS in hospitalized patients with high levels of blood sugars     and severe infections.   "
210543|NCT00605709|"     The purpose of this study is to determine the safety and tolerability of pharmaceutical     compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma     and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell     carcinoma by Compound 31510 topical cream.   "
210544|NCT00605722|"     This single arm study evaluated the efficacy and safety of a combination of Tarceva and     Avastin in patients with advanced or metastatic liver cancer. Patients were treated with     Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks. The anticipated     time on study treatment was until disease progression, and the target sample size was <100     individuals.   "
210545|NCT00605735|"     The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be     more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis     who are also taking methotrexate   "
210546|NCT00605748|"     We conduct a randomized study comparing the safety and effectiveness of two interventional     ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary     vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental     Isolation of the arrhythmogenic pulmonary vein(s)   "
210547|NCT00605761|"     Subject with Cystic Fibrosis have increased clearance of many drugs. Based on pre-clinical     data SB656933 was found to have low clearance and high bio-availability. This study will     characterize the PK profile of a single dose of SB656933 in patients with Cystic Fibrosis.     There will be two groups of subjects. The first group of subjects will receive a single dose     of 50mg SB-656933. The second group of subjects will receive a single dose of up to 300 mg     SB-656933. Subjects will first be screened for eligibility related to cystic fibrosis     history. Safety evaluations will be undertaken and plasma samples for pharmacokinetic     analysis will be collected. Additional blood samples will be taken for the pharmacodynamic     endpoints CD11b and GAFS. Subjects are not required to stay overnight after their 12 hour PK     sample collection on Day 1, although they may do so if they wish. On Day 2 and 3, they will     return for collection of additional safety measurements, and further plasma and blood samples     will be taken for 24 and 48 h pharmacokinetics and 24h CD11b/GAFS measurements, respectively.      A follow up visit (Visit 3) will be made 4-7 days after the treatment period. Subjects will     be enrolled in the study for approximately 3to 7 weeks (from screening to follow-up).   "
210548|NCT00605774|"     When a patient with Type 1 diabetes exercises, he or she is more prone to low blood sugar, or     hypoglycemia. It is known that antecedent exercise can blunt defense responses, called     counterregulatory responses to subsequent hypoglycemia in Type 1 DM, causing him or her to be     vulnerable to another bout of hypoglycemia. Epinephrine is one of the important hormones in     the defense of blood glucose during both exercise and hypoglycemia. We will test the     hypothesis that antecedent exercise will blunt the metabolic, neuroendocrine and     cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.   "
210549|NCT00605787|"     The aim of the study is to evaluate the short-term effects of tetradecylthioacetic acid (TTA)     on plasma lipids and glucose in male patients with type 2 diabetes mellitus and dyslipidemia   "
210553|NCT00605839|"     Among those with type I diabetes, adolescents can be among the worst at achieving glycemic     control. Behaviors normal in adolescent development (e.g., developing independence, rejecting     parental norms in favor of peers) can be at odds with the demands of effective diabetes     self-management. Modifying the family and patient interaction should be a crucial component     to improving the ability of an adolescent to manage his or her diabetes.      Mobile technology is becoming more popular in medicine, and adolescents, as a group are more     inclined to accept technology as an adjunct to care. Mobile technology that links adolescents     to health providers could help them to work through complex information that must be     processed to make good decisions. Since this assistance comes from health professionals, it     should help relax parents somewhat, thus reducing problems associated with parental     hypervigilance and manipulation of the regimen to avoid problems of hypoglycemia.     Parental-child conflicts may therefore be reduced by using cell phone glucose monitoring     technology that directly reports self-blood glucose monitoring data to providers and creates     a communication link to discuss therapeutic options.      This study investigates whether the use of mobile technology, in the form of a cell phone     glucose monitoring system, will help reduce the need for parents to assert behavioral     control, which can negatively impact adolescent diabetes self-management. The study will also     determine whether adolescents report improved quality of life, demonstrate competence in     diabetes management, and are able to achieve better control of their diabetes.   "
210554|NCT00605852|"     This study is designed to assess the safety and tolerability of single, escalating oral doses     and repeat oral doses (7 days, once daily) of GSK835726 in healthy male subjects   "
210555|NCT00605865|"     The objective of this surveillance is to collect information about 1) adverse drug reactions     not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug     reactions in this surveillance, and 3) factors considered to affect the safety and/or     efficacy of this drug.   "
210556|NCT00605878|"     This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and     how microbes contribute to health and disease. It will analyze healthy human skin and how the     these microorganisms might change in patients with atopic dermatitis (AD), a skin condition     also known as eczema.      Healthy volunteers, as well as patients with moderate to severe eczema (AD), between 2 and 40     years of age may be eligible for this study.      We also wish to enroll children and adults aged 2-40 who have been diagnosed with inherited     immune disorders known as HIES (hyperimmunoglobulin-E syndrome), WAS (Wiskott-Aldrich     syndrome), or DOCK8 immunodeficiency because they frequently have skin problems similar to     AD.      Eligible participants undergo the following tests and procedures:        -  Medical family and medication history        -  Skin examination        -  Blood tests (research blood as well as serum IgE, and complete blood count)        -  Skin samples to analyze microbes. Samples are obtained by the following methods:          swabbing the skin with a cotton swab; scraping (scratching) the skin gently with a blade          to remove only the outermost skin layers; and, only in adults, biopsy (surgical removal)          of a small skin sample less than 1/4-inch (5 mm) in diameter.        -  Nose swabs to analyze microbes.        -  Patients with eczema may have photographs of their skin taken to help monitor the skin          rashes.      Participants may be contacted periodically for follow-up studies. Patients with atopic     dermatitis may have additional skin samples collected to examine changes in the skin bacteria     over time and during all of the stages of eczema. In addition, patients who have a flare of     their eczema are asked to undergo a skin sample collection as soon as possible.   "
210557|NCT00605891|"     The purpose of this study is to identify the optimal once-daily dose of CHF 4226 to be     further developed for the treatment of patients with COPD.   "
210558|NCT00605904|"     This study will determine if acamprosate, a drug approved to treat alcoholism, decreases     alcohol cravings in alcohol-dependent subjects following infusions of yohimbine and mCPP.     Yohimbine causes anxiety and may provoke a desire for alcohol; mCPP induces a feeling of     having had a few drinks, which often creates a desire for more drinks. If acamprosate can     prevent a craving following these stimuli, then the effectiveness of new experimental drugs     for treating alcoholism can be tested for their ability to block yohimbine or mCPP-induced     cravings. This type of investigation would be less expensive and less time-consuming than     conducting clinical trials with alcohol-dependent people.      People between 21 and 65 years of age who are alcohol-dependent and have been drinking     regularly for at least 1 month before entering the study may be eligible to participate.      Participants are admitted to the NIH Clinical Center for about 35 days, during which time     they are asked to participate in an alcohol treatment program. They may request passes to     leave the hospital during the day but must return overnight. Upon return to the hospital,     subjects are required to take a breathalyzer test for alcohol and urine screen for drug use.     Participants found to have used drugs or consumed alcohol while away from the hospital are     terminated from the study.      Participants are randomly assigned to take acamprosate or placebo pills three times a day for     about 2 weeks. They are then given three intravenous (through a vein) infusions, 5 to 7 days     apart, each containing either yohimbine, mCPP or placebo. The drugs are infused for 20     minutes following a 1-hour infusion of saline (salt water). Subjects complete two     questionnaires - an alcohol urge questionnaire to assess the desire for alcohol and a PASS     rating scale to assess anxiety - several times during the study and during the infusions....   "
210559|NCT00605917|"     The objective of this surveillance is to collect information for panic disorder patients     about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions),     2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to     affect the safety and/or efficacy of this drug.   "
210560|NCT00605930|"     This study intends to study the safety and tolerance of the combination of pyruvate,     creatine, and niacinamide over 6 months in patients with PSP.   "
210572|NCT00606086|"     The GI-5005 therapeutic vaccine in combination with standard of care or standard of care     alone will be injected under the skin of HCV subjects. Patients will be monitored for safety,     immune responses and any therapeutic benefits related to the injections including EVR, ETR,     and SVR.   "
210573|NCT00606099|"     This study is designed to evaluate the efficacy and safety of telbivudine 600mg versus     adefovir dipivoxil 10mg in patients with compensated chronic hepatitis B.   "
210574|NCT00606112|"     The purpose of this study is to evaluate the safety and tolerance of a single intravenous     (through a vein) dose of trodusquemine (MSI-1436) in obese, type 2 diabetics.      Different amounts of trodusquemine (MSI-1436) will be given to each volunteer group     throughout the study.      Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug     enters and leaves the blood and tissues over time) of trodusquemine (MSI-1436).      Finally, this study will also determine whether trodusquemine (MSI-1436) has any effect on     appetite, mood or behavior, and selective biomarkers (substances in your blood that may     change in response to the study drug).   "
210561|NCT00605943|"     This study will measure antibody levels in the blood of people with bleeding or swelling in     the retina who have or have not been treated with bevacizumab (Avastin[Trademark]or     ranibizumab (Lucentis[Trademark]). These drugs have been useful in reducing retinal bleeding     and swelling in people with eye diseases that cause these symptoms, but the drugs' effects     usually wear off and they have to be given repeatedly. In some patients, the benefits become     less and less. It is possible that over time, patients taking these drugs may produce     antibodies that act against the drugs, thus neutralizing their effects and preventing them     from working properly.      People 18 year of age and older who are participating in a current NEI protocol and meet the     following criteria may be eligible for this study:        -  Are receiving injections of bevacizumab or ranibizumab for bleeding or swelling in the          retina, but the treatment is becoming less effective        -  Are receiving injections of bevacizumab or ranibizumab for bleeding or swelling in the          retina and the treatment is still effective        -  Have bleeding or swelling in the retina, but have never received either bevacizumab or          ranibizumab      Participants have blood samples drawn once when they start the study, once in the middle of     the study, and once at the end of the study. They are asked permission for study researchers     to review the results of their eye examinations at NIH.   "
210562|NCT00605956|"     Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity     response that requires the presence of ultraviolet irradiation. The predictive procedure is,     therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). Duplicate     sets of patches of test articles are used with exposure of only one set to UV radiation and     subsequent evaluation of both sets for skin reactions in order to compare irradiated versus     non-irradiated test sites.   "
210660|NCT00600405|"     The purpose of this study is to determine the efficacy of the α-adrenergic antagonist     tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic     secondary to lower ureteral calculus. We hypothesize that there will be no difference in     outcomes for subjects treated with and without tamsulosin.   "
210563|NCT00605969|"     One of the leading causes of hip arthritis is femoro-acetabular impingement which means the     hip joint is deformed such that the hip joint jams in the front when the hip is bent all the     way forward. This can lead to significant damage to the hip joint and may result in the need     for a total hip replacement. However, if detected early, this deformity can be treated     surgically by reshaping the hip joint. If the hip joint could be better visualized before     surgery, then surgeons would be able to develop less invasive surgical techniques to correct     this deformity.      In this study, we are trying to develop a way to help surgeons visualize the hip joint before     surgery in order to assist with pre-operative planning. This will be done by comparing the     dynamic hip images in patients with femoro-acetabular impingement to the hip images of     healthy volunteers with no hip problems.   "
210564|NCT00605982|"     Breast MRI is a fairly new technology, but it has been well studied. It is now used routinely     in many patients with breast cancer. It has been shown to be useful in detecting areas of     cancer that cannot be seen using other types of scans or tests.      The purpose of this study is to see how often MRI can find other areas of cancer in women     with one area of breast cancer, and to determine how having the MRI test affects their     treatment. The purpose is also to study any areas of abnormality seen on your MRI with     special methods that allow the images of your breast tissue and the microscopic analysis of     your breast tissue to be compared very carefully. The study also aims to follow women who     enter the study over a 10-year period to determine how often the breast cancer comes back.   "
210565|NCT00605995|"     The overall purpose of this study is to determine whether the cholesterol-lowering drug     simvastatin is effective in the treatment of symptoms of schizophrenia. The primary     hypothesis is that patients with schizophrenia receiving add-on treatment with simvastatin     will improve clinically (as measured mainly by symptom severity) compared with patients     receiving placebo, and that this improvement will be accompanied by concomitant reduction in     peripheral inflammatory markers.   "
210566|NCT00606008|"     We are asked patients to take part in this study because they had recurrent (returned) (1st     or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).      The purposes of this study are:        -  To see if Sutent has any change on the patient and their cancer.        -  To see if Sutent will slow or stop the growth of their tumor.        -  To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved          to treat patients with a gastrointestinal stromal tumor after the disease worsened while          taking another medicine called imatinib mesylate or when imatinib mesylate cannot be          taken. Sutent is also FDA approved to treat patients with advanced renal cell carcinoma.          At this time, it is not known whether Sutent will improve symptoms, or help patients          with this disease live longer.   "
210567|NCT00606021|"     This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed     plus best supportive care with best supportive care alone as maintenance therapy following     first-line treatment with a pemetrexed-cisplatin combination in patients with advanced     non-squamous non-small cell lung cancer.      A total of approximately 100 patients are planned to be enrolled, and following completion of     four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease     progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms     (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive     care alone).   "
210568|NCT00606034|"     Patients with Type 2 diabetes and severe insulin resistance with very large insulin     requirements who have failed all previous insulin regimens using non-concentrated forms of     insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular     insulin)infused via insulin pump.   "
210569|NCT00606047|"     Femoroacetabular hip impingement syndrome is a newly recognized cause of early arthritis of     the hip. In this condition a variation in the shape of the upper thigh bone causes it to     repeatedly come in contact with the hip socket leading to cartilage damage and arthritis. The     purpose of this study is to investigate whether patients without hip pain have variations at     the hip joint such as those seen in hip impingement syndrome.   "
210570|NCT00606060|"     Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in     the treatment of patients with hemophilia A undergoing major elective surgery by achieving     the required therapeutic concentrations.   "
210575|NCT00606125|"     The purpose of this study is to:        1. Evaluate how the body reacts to sorafenib when taken daily in combination with          paclitaxel and carboplatin,        2. Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times          after taking the medication, and        3. To determine the safety of sorafenib.   "
210576|NCT00606138|"     Diabetic neovascularization refers to a type of diabetic retinopathy which is worsening by     the abnormal growth of blood vessels in the back of the eye, damaging the retina. The usual     treatment is a type of laser, called panretinal photocoagulation. One drawback is that the     amount of space within the eye for use of this treatment eventually has its limit, and should     not be used too near the part of the retina used for detailed vision (the macula). In similar     eye disorders, there are certain injectable medications called anti-VEGF treatments which can     slow down or stop this abnormal blood vessel growth. This study sought to compare use of     ranibizumab versus standard panretinal photocoagulation in treatment of diabetic     neovascularization.   "
210577|NCT00606151|"     The purpose of this study is to determine if an intravenous (IV) antiplatelet medication is     as safe and effective at preventing clot formation in your stented artery as compared in     people who have stopped clopidogrel prior to surgery.   "
210578|NCT00606164|"     The main purpose of this study is find out how safe a single dose of bryostatin 1 is in     patients with Alzheimer's Disease (AD). This study is also being done 1) to determine how     effective a single dose of bryostatin 1 is in the treatment of AD, 2) to find out what     happens to bryostatin 1 once it enters the body by measuring the levels of bryostatin 1 in     blood, and 3) to measure a substance in the blood (protein kinase C) that may help to better     understand how bryostatin 1 works.   "
210579|NCT00606177|"     To investigate the safety and efficacy of long-term administration of aripiprazole by     performing extended administration of the treatment administered in the preceding     multicenter, double-blind, placebo-controlled, parallel group-comparison trial of     aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study     031-06-003, hereafter Study 003) in a double-blind manner to those patients who complete     Study 003 and demonstrate drug efficacy.   "
210581|NCT00606203|"     Depression is one of the important psychiatric sequelae after stroke. The prevalence of post     stroke depression (PSD) is approximately 20-40%. Depression comorbid with stroke has been     found to be associated with increased disability, cognitive function decline, poorer     rehabilitation outcome and higher mortality rate.We are going to conduct a trial of     prevention of psot stroke depression by prescribing milnacipran in advance.   "
210582|NCT00606216|"     The purpose of this study is to learn about possible changes in brain anatomy and in thinking     abilities, such as memory skills, in patients with cancer who receive treatment with     chemotherapy alone or in combination with total body radiation before undergoing stem cell     transplantation.   "
210583|NCT00606229|"     To assess the safety and efficacy of long-term administration of aripiprazole in combination     with mood stabilizer (lithium or valproate) in an unblinded manner in patients with Bipolar I     Disorder experiencing a manic or mixed episode   "
210584|NCT00606242|"     This study investigates the effect of a inhaled corticosteroid (fluticasone or Flovent) on     airway narrowing induced by hypertonic saline (salty water). The study hypothesis is that     fluticasone will be more effective in preventing saline-induced airway narrowing than     methacholine-induced narrowing.   "
210585|NCT00606255|"     Study Rational:      In general, chronic disease without symptoms such as hypertension, the treatment compliance     is relative low and is difficult to increase. The low compliance is related to poor     prognosis. There are many factors that effect to compliance of antihypertensive drug.     Education is one factor that can be controlled by doctors. Therefore, in this study, the     compliance of the patients in 3 groups of active training group, passive training group, and     no training group (usual treatment group) will be compared to evaluate the effect of training     for controlling of hypertension.   "
210586|NCT00606268|"     The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal     prophylaxis in children and adolescents undergoing HSCT   "
210587|NCT00606281|"     The primary objective of this trial is to evaluate the clinical efficacy and safety of     aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a     manic or mixed episode.   "
210588|NCT00606294|"     The main purpose of this study is to evaluate low oxygen areas called hypoxia within tumors.     These low oxygen areas are thought to be the reason why tumors are more resistant to     chemotherapy and radiation treatment.      An imaging technique using a hypoxia tracer called fluoromisonidazole (FMISO) can detect low     oxygen areas within a tumor. This imaging technique, called a PET scan, uses positively     charged particles to detect slight changes in the body's biochemistry and metabolism. FMISO     PET scans have been performed in patients with head and neck cancer and have shown the     ability to detect low oxygen areas within tumors.   "
210589|NCT00606307|"     In recent years several reports have documented that Histone Deacetylases (HDACs) inhibitors     induce neoplastic cells to undergo growth arrest, differentiation and/or apoptotic cell     death. Recently, inhibitors of HDACs has also been shown to inhibit endothelial cell     proliferation and angiogenesis in vivo. Several HDAC-inhibitors are currently in clinical     trials as novel anticancer agents. Among these agents, ITF2357 has most recently been shown     to be a potent inhibitor of the autonomous proliferation of haematopoietic cells from     patients with myeloproliferative disorders carrying the JAK2 V617F mutation. The aim of the     present study is to evaluate the efficacy and safety of ITF2357 in the treatment of     polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)   "
210590|NCT00606320|"     To assess the safety and efficacy of long-term administration of aripiprazole by performing     extended administration of aripiprazole in combination with mood stabilizer (lithium or     valproate) in an unblinded manner to those patients who completed the preceding multicenter,     double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients     with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter     Study 003) but whose condition worsened or remained unchanged or who discontinued Study 003     between Day 14 and Day 21 due to lack of drug efficacy.   "
210608|NCT00606554|"     The purpose of this study is to compare the efficacy of a computer-assisted ventilator     weaning system (Drager Smartcare) to our current standard of care in the medical intensive     care unit.   "
211714|NCT00615043|"     The objective of the study is to obtain bladder tissue specimens from patients otherwise     undergoing cystoscopy for use in research at Tengion, Inc.   "
210591|NCT00606333|"     The purpose of this study is to evaluate the safety and effectiveness of the Conor     Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single     atherosclerotic lesion) in native coronary arteries. The study will evaluate the outcomes of     a new drug-eluting stent compared to an approved drug-eluting stent.      While Cordis made a business decision to no longer pursue NEVO™ development and     commercialization, the patients will be followed up as per protocol. This includes performing     all protocol required follow-up visits and the collection and reporting of all safety     information.   "
210592|NCT00606346|"     The purpose of this study is to evaluate the long-term safety and clinical status of     pediatric patients with Inflammatory Bowel Disease (IBD). Particular attention will be     directed to recording safety outcomes reported in association with infliximab and other     prescribed IBD therapies. In addition, information on disease status and quality of life will     be collected.   "
210593|NCT00606359|"     Primary Objective:      To describe the immunogenicity of an injection of the investigational inactivated,     split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal     transplant subjects identified as non-responder to previous vaccination with the IM reference     vaccine (Vaxigrip®).      Secondary Objective:      To describe the safety of an injection of the investigational inactivated, split-virion     influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder     to previous vaccination with the IM reference vaccine   "
210594|NCT00606372|"     Previous studies comparing on-pump and off-pump operating strategy did only partially     demonstrate benefits of the off-pump myocardial revascularisation.In primary end-points (MI,     death, renal failure, and so on) there was no significant difference, but in secondary     end-points we observed benefits resulting for patients. We would like to show the benefit of     the method without extracorporeal circulation in patients with higher and hight operation     risk, coming from EuroSCORE classification system (6 points and more).   "
210596|NCT00606398|"     This is a Phase II study of combined surgical resection for patients with both intra- and     extra-hepatic metastases from colorectal cancer. The primary objective is to determine the     two-year disease free survival (DFS) of patients who undergo surgical resection of both     intra- and extra-hepatic metastases from colorectal cancer. The secondary objectives are to     determine the overall survival rate (OS), patterns of treatment failure, treatment efficacy     (R0 resection rate), peri-operative morbidity and mortality rates, health related quality of     life, and hospital length of stay.   "
210597|NCT00606411|"     The purpose of the study is to learn about the safety and effectiveness of oral (taken by     mouth) topiramate in treating Sleep-Related Eating Disorder (SRED).   "
210598|NCT00606424|"     [F-18]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging. This trial     is looking at the safety of [F-18]HX4.      The Sponsor is seeking to determine if [F-18]HX4 may serve as a clinically useful hypoxia     marker in diagnostic imaging, allowing the rational application of hypoxia related therapies     to those patients most likely to benefit from them.      Tumor hypoxia, a situation where tumor cells have been deprived of oxygen, caused cancer     cells to become more resistant to the effects of radiotherapy and chemotherapy.      A non-invasive study characterizing tumor hypoxia would facilitate the development of     targeted therapies.      The population to be studied consists of a total of ten (10) adult subjects, including, four     normal volunteers and six cancer subjects, the latter with a confirmed diagnosis of head and     neck cancer, as defined by the protocol eligibility criteria.      The objectives of this exploratory study are to:        -  Gain information on bio-distribution of [F-18]HX4, and to evaluate the PET images of          [F-18]HX4 for resolution, signal to background ratio for both intermediate levels of          oxygenation, and at extreme levels hypoxia        -  Use this eIND in order to obtain the necessary information to file an IND application          with the FDA. The information collected under this exploratory study will not be used          for diagnostic purposes, to assess the subject's response to therapy, or for clinical          management of the subject.        -  Begin collection of baseline imaging data        -  Collect [F-18]HX4 metabolism data        -  Gain information to improve study design and the conduct of future trials      This investigation will be conducted as an exploratory, open-label, non-randomized,     uncontrolled, single center, safety study.      The trial is expected to begin subject enrollment in early January 2008 and end subject     participation in June 2008.      The duration of an individual subject's participation includes a screening visit, followed by     participation in the actual study starting with the day of dosing with imaging sessions     lasting several hours, concluding with a next day safety follow-up visit.      Individual doses of [F-18]HX4 shall not exceed 20 mCi. The IP will be administered through a     previously placed suitably sized angiocatheter or a butterfly needle. Prior to injection,     qualified site personnel will assay the dose. After IP administration several PET imaging     series will be acquired. Also, in order to assess major organ function and electrolyte     levels, a metabolites analysis will be performed for this study from predose to 90 minutes     postdose.      In order to determine the quantity of [F-18]HX4 and labeled metabolites excreted by the     kidney,urine will be collected and pooled at the designated intervals after administration of     the investigational product. This excretion data will provide supportive information for     calculating human dosimetry estimates from PET imaging biodistribution data collected in     human subjects.      For cancer subjects, a tissue biopsy will have been taken or be scheduled to be performed.     The biopsy sample will be examined for hypoxic biomarker(s) using immunohistochemistry     methods.   "
210599|NCT00606437|"     Results to date of umbilical cord blood transplantation in adult and fully mature adolescent     patients are inferior to what is seen in children, due to a lower stem cell dosage in adults     and a more toxic conditioning regimen. This phase 1 protocol will use a potentially less     toxic bone marrow conditioning regimen, followed by infusion of a combined umbilical cord     blood graft that will provide the patient with a higher stem cell dose than can be given with     a single umbilical cord blood infusion. The subjects will be conditioned with a total body     irradiation (TBI) 13.5 Gy and fludarabine. Following conditioning, up to two unrelated,     partially matched umbilical cord blood grafts will be infused that will provide a minimum     nucleated cell dose of 3 x 10e7/kg . The primary objective of this study is to measure the     frequency of treatment-related toxicity and engraftment.   "
210600|NCT00606450|"     There is an unmet medical need for safe, effective oral therapy for moderate-to-severe     psoriasis. CC-10004 will be evaluated in a controlled setting of a clinical study. The     information obtained from the study will aid in the design of future clinical trials and to     establish the safety and efficacy of CC-10004.   "
210601|NCT00606463|"     Irrigated catheter for ablation of isthmus-dependent atrial flutter   "
210602|NCT00606476|"     This is a multicenter, open-label, long-term extension study in male and female patients with     mild to moderate Alzheimer's Disease (AD) who must have completed one of the following     studies: AAB-001-201 or AAB-001-102. All patients enrolled in Study AAB-001-251 will receive     infusions of AAB-001 (bapineuzumab), including patients randomized to placebo in Study 201     and 102. Approximately 30 study sites in the US will be involved. Each patient's     participation may vary from 3 months up to 84 months depending on the date of enrollment in     this study.      AAB-001 (bapineuzumab) is a humanized monoclonal antibody, which binds to and potentially     clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly     to the patient.   "
210603|NCT00606489|"     The primary objective of this study of Caldolor administered to hospitalized adult and     pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when     compared to placebo when administered every 6 hours for at least 24 hours.   "
210604|NCT00606502|"     The purpose of this clinical study is to determine the effectiveness (ability to provide     beneficial treatment of the disease) and safety of pralatrexate compared to erlotinib when     given to non-small cell lung cancer (NSCLC) patients who are current or former cigarette     smokers and who have received at least 1 prior treatment with a platinum drug (cisplatin or     carboplatin)   "
210605|NCT00606515|"     The purpose of this study is to determine whether there is any difference of the     pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in     Chinese cancer patients with solid tumors.   "
210606|NCT00606528|"     The main objective of this study is to assess whether a recently-developed bioassay for the     protein FGL2 can be used to predict the progression and/or response to treatment of Hepatitis     C Virus disease in patients with chronic HCV infection. The hypothesis is that increased     levels of FGL2 and increased numbers of T regulatory cells are associated with a failure to     respond to treatment.   "
210607|NCT00606541|"     Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of     quetiapine (extended release) XR for the treatment of social anxiety disorder (SAD); and 2)     continuation effects of quetiapine XR in preventing SAD relapse.   "
210609|NCT00606567|"     The purpose of this study is to determine if remote monitoring of implantable cardioverter     defibrillators (ICD), compared with quarterly device interrogations in clinic, will improve     patients' outcomes and satisfaction and will reduce health care costs.   "
210610|NCT00606580|"     This study will test the ability of the topical cream WR 279,396 to treat the skin lesions     caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that     contains paromomycin + gentamicin. This cream will be compared to the effect of a topical     cream containing paromomycin alone and to a placebo cream that contains no antibiotics.     Therefore, this study will have three groups of patients, and they will be assigned to one of     these treatments randomly. The study will be carried out without the patient or the physician     knowing which cream is being used for which patient. The goal is to determine if WR 279,396     cream or the paromomycin cream is better than placebo, and if WR 279,396 is better than     paromomycin alone.   "
210611|NCT00606593|"     A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and     tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with     primary insomnia.   "
210612|NCT00606606|"     Medications are the single most common form of treatment in the long-term care setting, and     often represent the most efficacious (and cost-effective) therapeutic modality used in this     clinical setting. However, the residents of nursing homes are at increased risk for     experiencing adverse drug events. This risk is increased by the physiologic decline and     pharmacologic changes that occur with aging, and also by the special clinical and social     circumstances that characterize institutional long-term care. In a study funded by the     National Institute on Aging (AG 14472), we have previously determined that adverse drug     events are common and often preventable in the nursing home setting and that the more serious     the adverse drug event, the more likely it is to be preventable. This study will test whether     a computer-based clinical decision support system can lower the rate of adverse drug events     (ADEs) and potential ADEs in the long-term care setting. The study design is a randomized     trial based in the resident care units of two large long-term care facilities. Within each     facility, half of the resident care units will be randomized to an intervention arm receiving     the computer-based clinical decision support system which will display warnings, messages,     and prompts based on resident and drug use characteristics; with over-rides by the prescriber     required for some warnings. Rates of ADEs and potential ADEs will be tracked by the study's     on-site clinical pharmacists prior to and during the intervention period. Rates will be     compared between units receiving and not receiving the computer¬based clinical decision     support system and to baseline, pre-intervention rates in the same units. We will track all     project costs directly related to the development and installation of the computer-based     clinical decision support system. We will also develop and test the sensitivity and     specificity of a computerized adverse drug event monitor and assess the validity of a nursing     home resident risk model developed in our prior study of adverse drug events in the nursing     home setting.   "
210615|NCT00606645|"     An open-label, multi-dose, single-arm, Phase 1 dose escalation study of XmAb®2513 was     conducted to define the MTD or recommended dose(s) for further study, to determine safety and     tolerability, to characterize PK and immunogenicity, and to evaluate antitumor activity of     XmAb2513 in patients with HL and ALCL (non-cutaneous) and who have received two or more prior     therapeutic regimens. There will be no intra-patient dose escalation.   "
210616|NCT00606658|"     This pilot study will attempt to test the effects of this non-invasive procedure on a small     sample of insomnia patients and also determine the feasibility of recruiting and retaining     participants during the trial for such treatments in the United States.   "
210617|NCT00606671|"     The scope of the study was to investigate different metabolic aspects that may lead to or are     a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome     (PCOS). We use gold standard methods for evaluation of insulin resistance. We take muscle and     fat biopsies for investigation of gene expression of different cytokines associated with     insulin resistance. We investigate the incretin hormones GIP and GLP-1. These two hormones     play a central role in glycemic control, and diabetic subjects are known to have alterations     in their incretin hormones. The incretin hormones have not previously been investigated in     women with PCOS.   "
210618|NCT00606684|"     This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic     Obstructive Pulmonary Disease (COPD)   "
210619|NCT00606697|"     Patients with Primary Insomnia will be treated with GW597599 and GR205171 to evaluate the     efficacy in the sleep difficulties associated with insomnia   "
210620|NCT00606710|"     The COGENT-4 Field Following Study will evaluate the clinical performance of the Boston     Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE     Cardiac Resynchronization Therapy ICD (CRT-D) systems and the RELIANCE 4-SITE defibrillation     lead (when available). An optional sub-study will also evaluate the clinical performance of     the Reverse Mode Switch (RMS) feature in the TELIGEN 100 HE DR ICD.   "
210621|NCT00606723|"     1. To evaluate whether stem cell transplantation from a matched sibling donor is equivalent          to a matched unrelated donor in in a second complete remission of acute myeloid leukemia          (AML).        2. To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema)          increases survival compared to a threshold derived from historical data        3. To evaluate whether SCT from haploidentical donors for children having no matched donor          will result in better survival with acceptable toxicity.   "
210622|NCT00606736|"     The purpose of this study is to determine whether the occurrence of idiopathic right     ventricular outflow tract(RVOT) arrhythmia is relative to sex hormone levels in different     stages of female menstrual cycle   "
210623|NCT00606749|"     The purpose of this study is to determine whether KC706 is effective in the prevention and     healing of blisters in patients with pemphigus vulgaris, while the patient remains on stable     doses of corticosteroids and/or immunosuppressants.   "
210624|NCT00606762|"     The physiological changes and postoperative pain are directly related with the degree of     intra-abdominal pressure kept during the laparoscopy. The present study aims to examine     difference between low pressure pneumoperitoneum (8 mm Hg)and High pressure pneumoperitoneum     (12 mm Hg)during laparoscopic cholecystectomy in terms of pain, cardio-pulmonary function,     arterial blood gas changes etc.   "
210625|NCT00606775|"     Purpose This cardiac dysfunction in patients with Duchenne muscular dystrophy is associated     with minor cardiac damage as indicated by elevation of plasma cardiac troponin I (cTnI). The     purpose of this study is to investigate whether the administration of Carvedilol can suppress     the minor cardiac damage and prevent deterioration of cardiac function.   "
228625|NCT00840515|"     A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the     prevention of radiation induced dermatitis.   "
210626|NCT00606788|"     The purpose of this study was to determine whether computer-driven protocolized weaning is     superior to physician-directed non-protocolized weaning in over-24-hours-ventilated surgical     intensive care unit (ICU) patients. The main hypothesis was that weaning duration differs     between both methods. Secondary hypotheses were that reintubation rate, duration of     mechanical ventilation, intensive care unit (ICU) length of stay and workload for physicians     and nurses differ between both methods.   "
210627|NCT00606801|"     To evaluate galantamine's effects on cognitive performance in abstinent cocaine users.     Galantamine, a medication approved for treatment of Alzheimer's disease, is an acetylcholine     esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both of these     effects may result in improved cognitive performance in a group of subjects known to have     impaired performance in various cognitive tasks.   "
210628|NCT00606814|"     This study is a Phase I clinical trial of IPI-504 in combination with docetaxel     (Taxotere).The purposes of the study are to determine:        -  the safety profile,        -  the highest dose of IPI-504 that can be given with docetaxel without causing severe side          effects, and        -  to recommend a Phase II dose of the combination in patients with solid tumors.   "
210629|NCT00599989|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.      PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy     and how well it works in treating women undergoing breast conservation therapy for     early-stage breast cancer.   "
210641|NCT00600158|"     Epidural local anesthetics are the gold standard for shortening duration of bowel dysfunction     after bowel surgery. Previous studies suggest that their effect may be in part a result of     actions of the local anesthetic outside the epidural space. If local anesthetics could be     administered intravenously instead, this might be a safer, easier and less expensive     approach. Therefore, this trial will compare the effect on bowel function recovery of     intravenous local anesthetics with those administered epidurally.   "
210642|NCT00600171|"     This study is designed to determine if the investigational drug is effective and safe in     individuals with asthma   "
210659|NCT00600392|"     Genes expressing inflammatory cytokines (TNF- alpha, IL1 etc) and genes involved in apoptosis     (Caspase 3, Bax, Bcl-2, Fas) are dysregulated in the skeletal muscles of the patients who     have muscle wasting and decreased exercise capacity with CHF.      Patients who show benefit from CRT may also show reversal of the inflammatory/apoptotic     cascade that accompanies CHF and these patients may be the ones who benefit the most from CRT   "
210630|NCT00600002|"     The application of immunotherapeutic strategies that target the most potent antigen     presenting cell, the dendritic cell (DC), are likely to substantially increase the magnitude     of the anti-tumor immune response. Although there are issues of activation state and antigen     load, mechanisms to increase the number of DCs available to the immune system are among the     first steps in development of affective DC based immunotherapeutic strategies. The Central     Hypothesis of our study is: Administration of Granulocyte Macrophage Colony Stimulating     Factor (GM-CSF) to patients with pancreatic adenocarcinoma will result in enhance recruitment     of DCs to the sentinel lymph node, into the peripheral blood, and/or tumor site. We propose     performing a phase I, dose escalation, clinical trial of systemic and intra-tumoral GM-CSF     administration for the treatment of pancreatic adenocarcinoma. This trial will be designed to     assess toxicity and immunologic effects, principally dendritic cell recruitment. Patients     with resectable pancreatic adenocarcinoma by clinical staging criteria will be eligible for     enrollment.      The trial we propose is a phase I clinical trial of the addition of GM-CSF as a biological     adjuvant to standard care for patients with potentially resectable pancreatic adenocarcinoma.   "
210631|NCT00600015|"     This trial will investigate the use of the newer targeted agents erlotinib and sorafenib in     patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens.     Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice     daily), or erlotinib (150 mg/day) and a placebo.   "
210632|NCT00600028|"     Idiopathic Pulmonary Fibrosis (IPF) is a rapidly progressive lung disorder that is often     associated with a chronic, intractable cough. The etiology of the cough associated with IPF     is unclear but it is often so severe that it adversely effects the patient's quality of life.     We propose that thalidomide specifically suppresses the cough associated with idiopathic     pulmonary fibrosis via its anti-inflammatory properties, by suppressing the excessive     functional up-regulation of sensory fibers with in the respiratory tract of patients with     IPF.      This study is a Phase III, double blinded, randomized, placebo controlled, crossover trial     testing the efficacy of thalidomide in suppressing the chronic cough of IPF. The primary     objective of this study is to determine the efficacy of thalidomide administered daily for 12     weeks to suppress the chronic cough in patients with idiopathic pulmonary fibrosis as     measured by cough specific questionnaires, scales and improved quality of life.   "
210633|NCT00600041|"     Recently, negative inotropy of pantoprazole has been shown in isolated human myocardium. This     study was designed to test the clinical relevance of this finding in healthy volunteers by     measuring left ventricular function during infusion of a common intravenous high dose regimen     of pantoprazole.   "
210634|NCT00600054|"     This is a phase 2, single-arm, multi-center study, with a safety review component, designed     to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with     recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their     disease. Patients must be diagnosed with radiologically verified recurrent diffuse intrinsic     pontine glioma that is measurable in at least two dimensions. Patients are eligible without     histologic confirmation. Treatment regimen will consist of two phases-induction and     consolidation.   "
210635|NCT00600067|"     The purpose of the study is to determine the long-term safety and efficacy of VI-0521     (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2     diabetic adults. Continuation of initial 6 month trial.   "
210636|NCT00600080|"     This study seeks to evaluate the clinical performance of a recently improved daily disposable     contact lens to an established daily disposable contact lens that contains a wetting agent.   "
210637|NCT00600093|"     The purpose of this study is to determine whether administrating of Amantadine (a dopamine     agonist) to patients suffering from Parkinson disease during the perioperative period is     safe, and to asses potential benefits of this treatment.   "
210638|NCT00600106|"     For the purposes of this study, as a core lab coordinating center, the investigators will be     performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses;     glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab     analyses; brachial artery reactivity test core lab analyses; full study data analyses for     manuscript preparation and the writing and submission and publication of manuscript.   "
210639|NCT00600119|"     Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized,     dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of     NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical     manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to     evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.   "
210734|NCT00607009|"     The objective of this study is to test the effectiveness of an email-based diet and physical     activity intervention on increasing physical activity and fruit and vegetable consumption and     decreasing intake of saturated and trans fats and added sugars.   "
210640|NCT00600145|"     The primary purpose of this study is to determine if Mirtazapine will produce a decrease in     interest in the drug, a decrease in mood elevation, and/or a decrease in reward when given     before methamphetamine compared to placebo.      Participants will be screened with a psychiatric interview, medical history and physical,     laboratory tests, drug of abuse screen and, if female, a urine pregnancy test. They will be     provided written informed consent. They will be studied in a within-subjects examination of     the subjective mood responses of mirtazapine and methamphetamine. Interactions between     methamphetamine and mirtazapine will be assessed by pharmacokinetic studies. Each participant     will be introduced to rating scales and cognitive tasks described below. Participants will     remain in the research unit for 5 hours on each day that they receive study medication or     placebo. They will spend five days in total on the research unit, one day separated by at     least one day; then in two day blocks separated by at least one day from another two day     block. A venous catheter will be placed for blood draws. Blood pressures and heart rates will     be recorded and assessed. Participants will be randomized and double blinded to receive     either placebo or mirtazapine orally two hours prior to the administration of randomized and     double blinded methamphetamine or placebo in order to have the peak effects of the drugs     overlap. VAS-mood, ARCI, GRS, POMS and POMS-E, neurocognitive tasks Trails A and B and Symbol     digits modalities test will be administered prior to the mirtazapine or placebo dose, and     repeated after the administration of methamphetamine or placebo. After the administration of     methamphetamine or placebo, vital signs will be assessed every 15 minutes and the measures     will be repeated until 120 minutes have passed from the initial dose of methamphetamine or     placebo. Blood will be drawn at one, three and four hour marks for pharmacokinetic testing.     This will be repeated on each testing day.   "
210656|NCT00600353|"     To assess emetic responses to multi-day doses of Palonosetron and Aprepitant and low dose     dexamethasone +/- Prochlorperazine among patients with multiple myeloma and lymphoma     undergoing autologous HSCT utilizing the Multinational Association for Supportive Care in     Cancer (MASCC) Antiemesis Tool (MAT).   "
210643|NCT00600184|"     The AMES device a investigational device which cyclically rotates the ankle while muscle     vibrators stimulate sensory receptors in the muscles opposite to the joint being rotated. In     effect, the device provides assisted movement of a joint and enhanced sensation of that     movement. The purpose of this study is to determine whether stroke survivors who remain     unable to move normally more than one year after their stroke will be able to walk and move     their affected leg significantly better after treatment with a new robotic therapy, the AMES     device.   "
210644|NCT00600197|"     The purpose of this study is to examine whether the biopsychosocial educational program could     improve patients' health-related quality of life at 3-6-12-18-24-30 and 36 - month follow up.   "
210645|NCT00600210|"     This trial is designed to study the safety and efficacy of the combination of carboplatin,     bevacizumab, and pelvic radiation therapy.      Rationale for substituting cisplatin with carboplatin:      Five landmark trials in cervical cancer prompted the National Cancer Institute in February of     1999 to issue a clinical announcement stating that strong consideration should be given to     adding concurrent chemotherapy in the treatment of invasive cervical cancer. The     chemotherapeutic agent which was a common denominator to all 5 trials was cisplatin, and ever     since it has become part of the standard of care for the treatment of stage IIB, III, and IVA     cervical cancers. In addition, chemoradiotherapy with cisplatin is also considered one of the     standard treatment options for IB2 and IIA tumors greater than 4 cm in diameter.      The most recent Gynecologic Oncology Group protocols for cervical cancer have used cisplatin     and radiation therapy as in two of the five landmark trials. However, the benefit in survival     given by cisplatin has not been without toxicity. In summary, in the trial by Keys 35% of     patients receiving cisplatin and radiotherapy experienced moderate or severe toxicities. In     the one by Rose, only 49 % completed the intended 6 cycles of chemotherapy.      Based on the toxicity profile of cisplatin, Higgins performed a phase II study of concurrent     carboplatin with pelvic radiation therapy in the primary treatment of cervix cancer. He     demonstrated the ability to administer carboplatin with concurrent radiation therapy with     significantly less toxicity and with 94 % of the planned treatments delivered.      A comprehensive analysis of the literature from 1998 which compared the efficacy of     carboplatin versus cisplatin in solid tumors concluded that for ovarian cancer and lung     cancer the effectiveness of carboplatin was comparable to cisplatin, while for germ cell     tumors, bladder cancer, and head and neck cancer cisplatin appeared superior. There was no     mention of cervical cancer in this review, since at present there is no phase III trial     comparing carboplatin versus cisplatin in cervix cancer.      Rationale for bevacizumab:      Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits     the biologic activity of vascular endothelial growth factor (VEGF) which stimulates tumor and     tumor blood vessel growth. Targeting VEGF with bevacizumab could potentially be of benefit in     cervical cancer patients by starving the tumor's blood supply and potentially enhancing the     effect of radiotherapy and carboplatin chemotherapy.   "
210646|NCT00600223|"     The purpose of this study is to evaluate the nature and quality of speech after removal of     the voice box and all or part of the swallowing tube.      The study is evaluating which type of surgery provides patients with the best speech and     voice.      These data will be used to help surgeons to design better ways to restore voice function     after removal of the voice box. Information about disease, its treatment, quality of life,     and physical and vocal function will be collected. An audio recording of vocal tasks will     also be done. All of this information will be analyzed and the two different subject groups     will be compared to see if there are differences.   "
210647|NCT00600236|"     One of the first causes of irreversible blindness in mexican population is diabetic     retinopathy which is clearly diferent between patients the time of evolution and development     of retinopathy and complications. The aim of this study is to explore the inmunogenetic     profile and the influence of HLA in this variations of the sickness to predict the severity     of diabetic complications.   "
210648|NCT00600249|"     The purpose of this study is to assess the pathological response rate in operable breast     cancer patients treated by neoadjuvant combination Taxotere-Erbitux.   "
210649|NCT00600262|"     Background: to evaluate the 3-month efficacy of a single dose of intravitreal bevacizumab on     the progression of severe non proliferative diabetic retinopathy, proliferative diabetic     retinopathy and active photocoagulated diabetic proliferative by evaluation of ischemic areas     and regression of retinal and disc neovasculrization.      Methods: 40 patients were enrolled in a prospective, interventional study. Patients were     treated with intravitreal bevacizumab 0.1ml (0.25mg). We evaluated visual acuity,     neovascularization leakage points, capillary closure ischemic areas and macular edema by     clinical examination and fluorescein angiography. A clinical examination was performed at     baseline and days 1,14 and 30. Active leakage points were measured by fluorescein angiography     at 30 days.   "
210650|NCT00600275|"     This is a phase I/II clinical research study with BGT226, an inhibitor of     phosphatidylinositol 3'-kinase (PI3K). The study consists of a Phase I dose escalation part     followed by a safety expansion part and a Phase II expansion part.      Once the MTD has been defined, the safety expansion and efficacy expansion parts of the trial     will be opened for enrollment.      Phase I safety expansion part will enroll advanced solid tumors. Phase II expansion part will     enroll advanced breast cancer. An effort will be made to enrich the trial population with     Cowden Syndrome patients with advanced solid malignancies.   "
210651|NCT00600288|"     The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium     Ophthalmic Solution, 2% in dry eye subjects.   "
210652|NCT00600301|"     Diabetic macular edema is the most common cause of visual loss among patients with diabetic     retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of     diabetic macular edema. Previous report showed a limited improvement in visual acuity and     macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal     injection has been proven be effective in the treatment of diabetic macular edema, in recent     publications. The purpose of this study is to evaluate whether vitrectomy with and without     intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and     macular thickness in patients with diabetic macular edema.   "
210653|NCT00600314|"     This study aims to show that the MedGem indirect calorimetry measurement device will be     feasible to use in children with GVHD. Also, it aims to show that children with chronic GVHD     will have elevated REE that is not adequately predicted by standard equations.   "
210654|NCT00600327|"     The primary objective of this study is to demonstrate the safety of the NexStent for     treatment of carotid artery lesions undergoing stenting with adjunctive use of the FilterWire     distal embolic protection device. The rates will be compared to an Objective Performance     Criterion (OPC) derived from historic data from high-risk patients undergoing surgical     intervention with Carotid endarterectomy. Patients included in this study are those at higher     risk for complications associated with CEA.   "
210655|NCT00600340|"     First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast     cancer who have not received prior chemotherapy for locally recurrent or metastatic disease.   "
210657|NCT00600366|"     This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of     biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing     on secondary oral hypoglycaemic agent (OHA).   "
210662|NCT00600431|"     Changes in nevus count in 16 children (8m, 8f) aged between 2 and 17 years (median:8 years)     suffering from different malignancies were examined every three months during a one-year     period after starting chemotherapy. An age and sex matched control group underwent the same     skin examinations.At the start of our study, the range of number of nevi in the chemotherapy     group was 0-133, in the control group 2-199.   "
210663|NCT00600444|"     The purpose of this trial is to investigate if the success rate of punction the vena     subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae     sectio (80% in retro and prospective studies) for implantation of a totally implantable     access ports.   "
210664|NCT00600457|"     The purpose of this study is to determine whether the combination of modified polyurethane     film and secondary absorbent dressing for skin graft donor sites avoids the regular     uncontrolled leakage, but holds up the advantages of film dressings for this kind of wound.   "
210665|NCT00600470|"     This study will evaluate the effectiveness of a doctor-office collaborative care approach in     treating children with disruptive behavior problems in the pediatric primary care setting.   "
210666|NCT00600483|"     The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and     effective in preventing sternal wound infections in patients undergoing cardiac surgery who     are at a greater risk of developing sternal wound infections.   "
210667|NCT00600496|"     This study is being conducted to determine if a combination of AZD6244 given orally twice a     day with standard doses of selected chemotherapies will be safe and tolerable for cancer     patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination     with selected chemotherapies will be evaluated. The study will also investigate how AZD6244     in combination with standard chemotherapies are absorbed, distributed and excreted by the     body as well as the length of time that the drugs remain in the body. Initial and periodic     assessments will establish patient response to the combination therapies.   "
210668|NCT00600509|"     Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and     safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with     partial onset seizures.   "
210669|NCT00600522|"     Major hepatectomies have not negligible morbidity and mortality. However, when tumors invade     middle hepatic vein (MHV) at caval confluence major surgery is usually recommended.     Ultrasound-guided hepatectomy might allow conservative approaches. We prospectively check its     feasibility in a series of patients carriers of tumors invading the MHV at the caval     confluence.   "
210670|NCT00600535|"     The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations     change over time) of capsule and tablet formulations of CB7630 (abiraterone acetate) taken     with and without food in patients with prostate cancer.   "
210671|NCT00600548|"     The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine     in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous     standard treatment (meglumine antimoniate - Glucantime®).   "
210672|NCT00600561|"     The purpose of this study is to investigate whether Mindfulness-Based Stress Reduction (MBSR)     vs a one-day MBSR seminar improves immune (CD4+ T lymphocytes) and virological (HIV viral     load) status in HIV-1 infected adults. The secondary goal of the study is to determine if     MBSR vs a one-day MBSR seminar improves self-reported HIV-related quality of life.   "
210673|NCT00600574|"     The purpose of the study is to compare the efficacy and tolerability of Ai Chi, an adaptation     of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology.   "
210674|NCT00600587|"     The purpose of this study is to evaluate the value of induction Erlotinib therapy before     thoracotomy or radiotherapy in ⅢA-N2 (confirmed by mediastinoscopy or PET) non-small cell     lung cancer (NSCLC) selected by epidermal growth factor receptor (EGFR) gene analysis and     initial to explore a new treatment strategy for ⅢA-N2 NSCLC.   "
210675|NCT00600600|"     To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients     with rapidly growing mycobacterial disease (especially M.abscessus).   "
210676|NCT00600613|"     The purpose of this study is to test a new and possibly more accurate method of positioning     patients with liver tumors in preparation for radiation treatment.      The positioning of patients with liver cancer is important because the tumor moves a bit when     you breathe and makes it hard to determine the right position of the tumor at the time of     treatment. Also, depending upon what is in your stomach at the time of treatment, it may     change the shape of the liver and make it difficult to plan the radiation treatment. As part     of this study, we will take a new type of image of your liver in addition to the standard     portal images. This new type of image is called a cone-beam image. It shows a much more     detailed picture of the liver tumors than the standard portal images. Normally, marker seeds     need to be placed near the liver metastasis for radiation treatment. If the results of this     study show that the tumor can be positioned as accurately with the new images as with the old     images, then future patients with liver tumors would not have to have marker seeds placed     into their liver. The use of cone beam imaging for the setup of patients with liver tumors is     new.   "
210677|NCT00600626|"     This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus     treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood     glucose control in type 2 diabetes.   "
210678|NCT00600639|"     The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the     studies performed in ICUs and in another facilities the mean age of the patients is usually     less than 70 years.      A multicentric, randomized-controlled trial conduced in a group of ELDERLY patients with     the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment     (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.   "
210679|NCT00600652|"     Monitoring the GR with a GR-MoAb and FITC-Dex probes by FCM would be useful and convenient in     determination GR before the steroid treatment in clinical, especially in steroid resistant     states, in order to design more efficient clinical treatment protocols.   "
210680|NCT00600665|"     Sickle cell disease (SCD) is a blood disorder that is characterized by intense, painful     episodes known as sickle cell crises. This study will evaluate the effectiveness of     PAINRelieveIt, a three-part computer-based pain management tool, in treating adults with SCD.   "
210682|NCT00600691|"     The purpose of our study is primarily to evaluate the effects of 5mg finasteride on hematuria     and hematospermia commonly associated with prostate biopsies. We hypothesize that 5mg of     finasteride daily for two weeks preceding TRUS prostate biopsy and one week following will     reduce hematuria and hematospermia commonly seen as complications following prostate biopsy.     We also hypothesize that reducing complications will decrease concern among subjects and make     for a more tolerable overall procedure than compared with subjects treated with placebo.   "
210683|NCT00600704|"     The investigators' hypothesis is that restriction of circulating fluids in comparison to a     liberal fluid administration policy would lead to a reduction of allogenic red blood cells     exposure in patients undergoing cardiopulmonary bypass (CPB) for primary coronary artery     bypass graft supported by reinfusion of washed shed blood from thoracic cavities.   "
210684|NCT00600717|"     The objective of this study is to use high-frequency brain signals (HFBS) to localize     functional brain areas and to characterize HFBS epilepsy, migraine and other brain disorders.     We hope to build the world's first high-frequency MEG/MEG/ECoG/SEEG database for the     developing brain. HFBS include high-frequency oscillations (HFOs), ripples, fast ripples or     high-gamma activation in the brain.      To reach the goals, we have developed several new MEG methods: (1) accumulated spectrogram;     (2) accumulated source imaging; and (3)frequency encoded source imaging.   "
210685|NCT00600730|"     The studies proposed in this application seek to use non-invasive techniques to examine the     impact of repeated hypoglycemia on the brain.   "
210686|NCT00600743|"     The ultimate aim of this study is to test the hypothesis that the oral cholecystokinin (CCK)     agonist GSKI181771X will reduce the size of a binge meal among individuals with Bulimia     Nervosa. The study will be conducted in phases. First, an effective dose for reducing food     intake, when normal subjects eat normally will be attained. Next, it will be determined     whether intake at this dose is reduced in control subjects instructed to eat to capacity. If     the dose is still effective compared to placebo, the same dose will be tested in patients     with bulimia nervosa.   "
210687|NCT00600756|"     The trial is designed to assess the long term subjective well-being in schizophrenic     outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible     dose in a naturalistic setting over a period of one year. Secondary outcome measures have     been selected for helping in the differentiation of the compared atypical antipsychotics. The     primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to     risperidone assessed at month 6 in terms of responder rate using the self-report instrument     SWN-K   "
210688|NCT00600769|"     Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium     avium-intracellulare and other non-tuberculous Mycobacteria   "
211772|NCT00615823|"     Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary     Hypertension: double-blinded, randomised, prospective phase II study for 6 months with     adjusted doses of Atorvastatin   "
210689|NCT00600782|"     This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB     vaccine administered at 0, 1 months to healthy adults living in a TB-endemic region. The     Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.   "
210690|NCT00600795|"     Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with     functional improvements after insertion of ventriculoperitoneal shunt for normal pressure     hydrocephalus   "
210691|NCT00600808|"     Annualised height velocity after 12/24 months treatment and HV SDS height velocity after     12/24 months treatment expressed as number of standard deviations difference from the mean     population height velocity for the appropriate gender and chronological age.   "
210692|NCT00600821|"     To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with     advanced lung cancer who have not been previously treated.   "
210693|NCT00600834|"     The objective of this long term study is to prospectively compare the incidence of NSF in two     cohorts (Cohort 1- patients with moderate chronic kidney disease eGFR 30-59 and Cohort 2-     patients with severe chronic kidney disease or kidney failure eGFR <30).   "
210694|NCT00600847|"     The aim of this study is to compare cold urticaria lesions by thermography, volumetry and     digital time lapse photography in ACU patients treated with placebo, 5 mg and 20 mg     desloratadine. Hypothesis: The updosing of desloratadine (20 mg)is more effective in the     treatment of ACU symptoms as compared to standard doses (5 mg desloratadine) and placebo.   "
210695|NCT00600860|"     Study Objectives:      To collect and describe demographics, disease-management, and treatment outcomes of     Myelodysplastic Syndromes (MDS) patients who are newly diagnosed and classified according to     the WHO criteria.      To perform observational studies concerning relevant scientific research questions in MDS     using clinical data and biological samples, and to present relevant research outcomes in the     fields of diagnosis and prognostication, health related quality of life issues, health     economics, and risk stratification for newly developed classes of drugs.      To disseminate results of the studies to all stakeholders involved.   "
210696|NCT00600873|"     R(+)pramipexole is administered in escalating doses to patients with early ALS. Plasma and     spinal fluid levels of R(+)PPX are monitored, in addition to biochemical markers of oxidative     stress.   "
210697|NCT00600886|"     The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.      The objective of this study was to compare the proportion of patients with a reduction of     mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and     sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12     months.      Following one year of treatment patients could proceed into the study extension.      Patients who did not respond to the treatment they were randomized to (based on month 12     assessment results) were switched to the other treatment arm at month 13.   "
210698|NCT00600899|"     The purpose of this double blind, randomized study is to evaluate which rate and duration of     infusion can be recommended for continuous perisciatic infusion of ropivacaine 2 mg/ml for     analgesia after ambulatory foot surgery.   "
210801|NCT00612001|"     RATIONALE: Vaccines made from peptides and a person's dendritic cells may help the body build     an effective immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with malignant glioma.   "
210699|NCT00600912|"     Lipid emulsions are an essential part of parenteral nutrition, both as a part of energy     supply, and as a source of essential fatty acids. It has been shown that the fatty acid     composition of cell membranes is influenced by the fatty acid profile of dietary lipids, and     may therefore be responsible for modulation of immune response. The aim of this study was to     assess the effects of a new lipid emulsion based ob soybean oil, medium-chain triglycerides,     olive oil and fish oil compared with a lipid emulsion based on olive and soybean oil on the     inflammatory response and hepatic function in postoperative intensive care unit (ICU)     patients.   "
210700|NCT00600925|"     The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and     effective for preventing surgical wound infections in patients undergoing colorectal surgery.   "
210701|NCT00600938|"     This is a clinical research study in patients who have iron overload in the heart due to     chronic blood transfusions.      The study will have 2 treatment groups and will compare the safety and efficacy of chelation     therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine     (DFO). The study is aimed at finding out which of the two medicines is the best for treating     iron overload in the heart.      Patients will be treated for 12 months (core study phase). Patients who complete the core     study phase will be offered to continue their study treatment in a 12 months extension phase.     During the core and extension, the effects of treatment on iron overload in the heart and the     liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.   "
210702|NCT00600951|"     The objective of this long-term study is to prospectively compare the incidence of NSF in two     cohorts (Cohort 1 - patients with moderate chronic kidney disease eGFR 30 to 59 and Cohort 2     - patients with severe chronic kidney disease or kidney failure eGFR <30).   "
210703|NCT00600964|"     This protocol is being run to determine the best phase II dose and schedule of obatoclax in     patients with previously untreated CLL.   "
210704|NCT00600977|"     Phase II multicentric study comparing VAD regimen with continuous infusion over 96 hours of     doxorubicin, vincristine and dexamethasone to a 90 minutes infusion of equivalent doses of     Dox li-PEG, bolus infusion of vincristine and dexamethasone   "
210705|NCT00600990|"     The purpose of this study is to determine the effectiveness of this medication in preventing     nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV).   "
210706|NCT00601003|"     The purpose of this study is to determine whether nifurtimox in combination with     cyclophosphamide and topotecan are effective in the treatment of relapsed or refractory     neuroblastoma and medulloblastoma.   "
210747|NCT00611299|"     The purpose of the study was to investigate the dose-response effect of increasing doses of     Bifidobacterium animalis ssp lactis (BB-12) and Lactobacillus paracasei ssp paracasei     (CRL-431) on the immune response, blood lipids, gut microflora, recovery from feces and     overall tolerance in healthy young adults.   "
210748|NCT00611312|"     The purpose of this study is to see if an intense two-week long cognitive training program     helps the thinking ability of adults with very mild Alzheimer Disease. We anticipate that     scores on clinical cognitive tests will be better after the training.   "
210707|NCT00601016|"     Hemangiomas of infancy, the most common benign tumors of infancy, are congenital or early     infancy lesions characterized by a rapid postnatal growth, with high expression of angiogenic     stimulators for 9-18 months, followed by slow regression for 5-9 years. Current therapies for     the hemangiomas are usually restricted to more severe forms due to the risks of adverse     effects, inconvenience and cost. Nevertheless, a substantial amount of the psychological     discomfort and morbidity can be caused by untreated hemangiomas, especially those in the     face.      Recently, Imiquimod 5% cream has emerged as a safe an effective drug for several skin     conditions that benefit from modulation of the activity of the immune system, such as common     warts and various forms of the skin pre-cancerous and cancerous lesions. Small case reports     series have suggest that it could also be useful in hemangiomas, possibly through the     inhibition of the angiogenesis by local IFN production.This is a small, open label study of     16 patients to document the efficacy of the Imiquimod 5% cream in the treatment of hemangioma     of infancy (primary outcome). IFN and plasma drug levels, as well as clinical examinations     and blood studies, will be carried out to evaluate safety of the treatment (secondary     outcome). bFGF and VEGF will be measured in blood and urine in order to study the diagnostic     and predictive value of these pro-angiogenic factors in the response of hemangiomas to the     treatment with Imiquimod (secondary outcome).      The study is a phase II clinical trial of a once a day application of Imiquimod 5% cream, 3     to 7 times per week for a maximum of four months. The study held at the Dermatology Clinic of     Sainte-Justine Hospital, and was completed within a 20 months timeframe after IRB approval.   "
210708|NCT00601029|"     The purpose of this study is to:        1. develop a normative database for serum creatine kinase (CK) responses to basic military          training (BMT);        2. determine the incidence of exertional rhabdomyolysis (ER) among a large cohort of          recruits undergoing BMT;        3. assess the impact of climate on the incidence of ER during BMT;        4. determine the incidence of candidate genes that may be associated with an increased risk          of ER.   "
210709|NCT00601042|"     The study aims to establish if a low-nitrosamine, smokeless tobacco product (Swedish snus)     can help adult smokers to reduce and eventually completely quit smoking.   "
210710|NCT00601055|"     This study will evaluate the effectiveness of problem-solving therapy combined with treatment     adherence procedures in treating older people with major depression and chronic obstructive     pulmonary disease.   "
210711|NCT00601068|"     In cooperation with Merck & Co, Inc. we will identify and form a database of 35 patients who     have developed osteochemonecrosis of the jaws related to oral bisphosphonate use. We will     study the triggers, associated medical conditions and medications, location of the lesion(s),     and patient outcomes.   "
210712|NCT00601081|"     This is a research study investigating if adding human milk fortifier to a preterm babies     breast milk feedings affects the baby's immune system.   "
210713|NCT00601094|"     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective     immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.   "
210714|NCT00601107|"     The purpose of this study was to evaluate the safety and effectiveness of an investigational     drug called doxercalciferol in participants with moderate to severe chronic plaque psoriasis,     in comparison with a placebo (sugar pill). All study related care was provided including     doctor visits, physical exams, laboratory tests and study medication. Total length of     participation was 28 weeks.   "
210715|NCT00601120|"     The purpose of this study is to look at the effects of a procedure called radiofrequency     ablation on kidney tumors from patients who are undergoing antiangiogenic treatment.     Antiangiogenic treatment is a type of treatment that inhibits formation of new blood vessels     that are required for tumor growth. Radiofrequency ablation (RF ablation) involves inserting     a needle into tumor tissue and administering heat to the tumor tissue that is sufficient to     kill the tumor cells.   "
210716|NCT00601133|"     Objectives:      Primary Objectives:      To determine the change in functional tests of postural control of cancer patients who have     completed acute inpatient rehabilitation or complete rehabilitation through mobile team from     discharge at 21-60 days (+/- 3) after discharge.      Secondary Objectives:      To assess the correlations between the functional tests of postural control, the balance test     and the amount of exercise per week.   "
210717|NCT00601146|"     This research study is being done because patients with a history of chest radiation     treatment for Hodgkin's disease have been shown to be at increased risk for developing lung     cancer a number of years out from treatment. The risk appears to be further increased among     patients with a smoking history. Currently, the practice is to recommend annual low-dose     chest CT scans in survivors of Hodgkin's disease who have received prior chest radiation     treatment and who have at least a moderate smoking history. In this study, the CT scans will     be read and interpreted by the study radiologist, and the results recorded in a consistent     manner.   "
210718|NCT00601159|"     Primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as     first line therapy in patients with triple-negative MBC. 80 patients will be treated into     this study.   "
210719|NCT00601172|"     This a Phase III trial designed to determine if IV casopitant plus dexamethasone and     ondansetron is more effective in the prevention of vomiting and nausea then dexamethasone and     ondansetrone alone following the administration of moderately emetogenic oxaliplatin-based     chemotherapy.   "
210720|NCT00606827|"     Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal     failure. Hydration with sodium bicarbonate is more protective than isotonic saline in     animals. Limited data are available in humans. We compared the efficacy of sodium bicarbonate     versus isotonic saline to prevent CIN in a large population of patients with renal     dysfunction undergoing coronary angiography or intervention.   "
210721|NCT00606840|"     The specific aim of the proposed project is to test two separate self-regulation     interventions to prevent weight gain in young adults, one based on making sustained small     changes in behavior to prevent weight gain and the other on making periodic larger behavior     changes resulting in weight loss.   "
210794|NCT00611910|"     The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents     to reduce reblockage of bypass grafts after coronary stenting   "
210722|NCT00606853|"     The purpose of this study is to address the conditions under which prize contingency     management (CM) for abstinence and attendance may improve outcomes of cocaine-dependent     patients.      For patients who initiate treatment with a cocaine-positive urine specimen, we will evaluate     the efficacy of two CM procedures relative to standard, non-CM treatment. The two CM     procedures will be provided as additions to standard care and will reinforce drug abstinence     but will differ in expected magnitudes of prizes patients can earn, especially during early     stages of abstinence. They will provide expected magnitudes of winning about $250 and $560,     respectively. We expect that both CM conditions will improve retention and abstinence     relative to the standard treatment, non-CM condition. If the enhanced CM condition engenders     better outcomes than the $250 CM condition, this finding would suggest that patients     initiating treatment while actively using cocaine may best be treated with relatively high     reinforcement prize CM as an adjunct to standard care.      For patients who initiate treatment with a cocaine-negative urine specimen, we will evaluate     the efficacy of a CM procedure that reinforces treatment attendance. The expected magnitude     of winnings will be about $250, and again CM treatment will be in addition to standard care.     This CM condition will be compared to standard treatment without CM as well as to a CM     treatment that provides a similar magnitude of reinforcement, but contingent upon abstinence.     Results from this study will inform an important clinical question of whether simply     reinforcing attendance can improve clinical outcomes. Increased retention may result in     greater exposure to therapeutic processes that may reduce drug use, especially among patients     who begin treatment having already achieved some abstinence. We will also evaluate the     cost-effectiveness of CM by examining the effects of the interventions on hospitalizations,     medical and psychiatric care, criminal justice costs, and productivity.   "
210723|NCT00606866|"     The purpose of this study is to determine maximum tumor shrinkage, time to progression,     survival, drug concentration, and degree of skin toxicity.   "
210724|NCT00606879|"     SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity     may be important in growth and survival of some types of cancer. This Phase I trial is     studying the safety, side effects, and best dose of SGX523 when given to patients with     advanced cancer, and how well it inhibits MET activity in tumors.   "
210725|NCT00606892|"     To examine the effects of varenicline on the subjective, physiological and cognitive     responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is     approved as a treatment for smoking cessation. We predict that varenicline treatment will     modify subjective, physiological and cognitive responses to IV nicotine.   "
210726|NCT00606905|"     Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are     trying to establish a family. This clinical study will evaluate the effectiveness of     intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from     secondary recurrent miscarriage. This study will help in providing an answer to the question     of whether IVIG is helpful in secondary recurrent miscarriage.   "
210727|NCT00606918|"     There is a great need for the development of sensitive outcomes that allow experimental drugs     to be tested in human subjects more efficiently. If we could more precisely measure whether     an experimental drug slows the progression of ALS or other neuromuscular diseases, this would     allow more drugs to be tested quicker and at less expense. We have developed a new device     that accurately measures isometric strength called: Accurate Test of Limb Isometric Strength     (ATLIS). This device was designed to be portable, quick, and easy to use, while generating     accurate and reliable, interval level data. This study will enable us to test the reliability     and validity of ATLIS.   "
210802|NCT00612014|"     The purpose of this study is to determine whether TZP-101 is effective in the treatment of     symptomatic gastroparesis due to diabetes.   "
211100|NCT00618020|"     The CiTop™ guidewire Coronary study is a feasibility open label study, to evaluate the safety     and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Coronary     arteries.   "
210728|NCT00606931|"     The purpose of this pilot clinical study is to test a methodology for using high-resolution     Positron Emission Tomography (PET) imaging to guide vacuum-assisted core biopsy of breast     abnormalities identified on PET. In order to implement the PET guidance, the study uses the     Stereo Navigator accessory to the high-resolution organ-specific PET scanner (PEM Flex™ PET     Scanner, Naviscan PET Systems, Inc., San Diego, CA). The Stereo Navigator is an     investigational device intended for guiding biopsy needles toward lesions in breasts     identified by a physician on a high resolution PET image. The study will evaluate the     clinical utility of the Stereo Navigator in guiding the vacuum-assisted core biopsy of breast     abnormalities, following the example of prior studies of breast biopsy guided by magnetic     resonance imaging (MRI)   "
210729|NCT00606944|"     The purpose of this study is to address the question of whether or not oral alimentation and     ambulation exercise should be begun early in patients following laparoscopic colorectal     surgery compared to the classical diet and ambulation which depends on reappearance of     functional intestinal transit. Early oral alimentation following laparoscopic colorectal     surgery may decrease hospital stay and facilitate earlier discharge with comparable     postoperative morbidity.   "
210730|NCT00606957|"     The reason for doing this study is to learn whether raising a person's vitamin D level from     below normal to normal levels will improve his or her body's ability to use sugar. Vitamin D     is well known to be an important vitamin for the development and maintenance of bones.     Recently, scientists have learned that vitamin D may have a role in the prevention of cancer,     diabetes, and autoimmune diseases. The investigators are specifically interested in studying     this question in the overweight/obese population as they are at greater risk for both vitamin     D deficiency and impaired ability to metabolize sugar (glucose intolerance).      Primary Hypotheses:      Vitamin D repletion (increasing the serum 25(OH)D level from ≤ 20 ng/ml to ≥ 30 ng/ml) will     improve insulin sensitivity in individuals who are overweight/obese and insulin resistant.      Secondary Hypotheses:      1.Vitamin D repletion will improve biomarkers of cardiovascular risk and inflammation     (directly altering macrophage cytokine production and/or indirectly as a result of     improvement in insulin sensitivity.) 2.30,000 IU (0.25 mg) weekly of cholecalciferol (vitamin     D3) will raise serum 25(OH)D levels from ≤ 20 ng/ml to ≥ 30 ng/ml overweight/obese     population.   "
210731|NCT00606970|"     Project: Assessment of the safety of dietary supplement lactobacillus fermented extract in     cancer patients undergoing chemotherapy      Nausea and vomiting are significant causes of nutritional depletion and result in further     deterioration of the physical and mental status. Support of gastrointestinal function may     alleviate nausea and vomiting from chemotherapy and will not only reduce the discomfort     experienced by the patient but will allow better tolerance of the treatment. This study will     assess orally administered Seigen alpha EV during chemotherapy for its safety and effects on     the nutritional depletion deriving from the chemotherapy. It will also look at its effect on     the immune system in patients undergoing chemotherapy.   "
210732|NCT00606983|"     Various adrenergic blockers are used for acute voiding difficulty after proctectomy.     Recently, a selective alpha5-adrenergic blocker, Tamsulosin has been reported to have benefit     in reducing urinary symptom score and in reducing the rate of intermittent     self-catheterization for patients with rectal cancer after radical proctectomy.      This study is to evaluate the efficacy of pharmacologic prevention to ameliorate the     incidence of postoperative urinary dysfunction.   "
210733|NCT00606996|"     The purpose of the study is to determine whether interpersonal psychotherapy is effective for     treating co-occurring depression and substance use among women prisoners.   "
210735|NCT00607022|"     This is a research study to test the clinical procedure and not the FDA approved medical     device. This project will screen up to 80 volunteers to enroll 40 active subjects to receive     a single tooth implant on an anterior (incisor/canine) or pre-molar tooth in the mandible or     maxilla (no implants will be placed in molar sites). This 3 year research study will examine     the clinical effects of loading regimens on roughened surfaced implants. The proposed     research project will measure the changes in mucosal healing and maturation over a three year     period following implant placement. The proposed research lays the foundation for improved     health care by providing surgeons and restorative dentists with data for determining the     relationship between implant healing, loading pattern and bone type. The rationale that     underlies the investigation is that identification of the influences of timing of load on     implant stability in varying bone types will allow routine, predictable use of early loading,     which, in turn, will translate into more rapid health care, and improved psychosocial     well-being of the patient. If these hypotheses are correct, these results are expected to     provide evidence based research data to support early loading and immediate loading of single     implants in sites of adequate bone volume, and density. In addition, it is expected that     these results will fundamentally advance the field of implant dentistry and bioengineering by     providing information on the principles of the bone density-mechanical environment-implant     stability interaction.   "
210736|NCT00607035|"     The purpose of this study is to investigate which combination therapy is more effective for     improving the blood pressure (BP) and reducing target organ damage in Japanese hypertensive     patients: Angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB     plus diuretics.   "
210737|NCT00607048|"     This is a dose-finding study; therefore, there is no hypothesis testing   "
210738|NCT00607061|"     The aim of the study is to determine mechanisms leading to glutathione deficiency in low     birth weight newborn babies. Compared to full term neonates, depletion in this population may     be due to a decreased synthesis rate or to an enhanced utilization or a combination of both     mechanisms.The protocol is constituted of two steps. The objective of the first step is to     quantify the blood concentration of glutathione in the artery and the vein of umbilical cord     in full term newborn babies. Objectives of the second step are to determine if the     glutathione synthesis rate, measured in vitro, is lower in erythrocytes collected from     umbilical cord blood of low weight newborn babies compared to full term newborn babies. In     this case, the next objective will be to determine if the adjunction of an excess of cysteine     in vitro can restore the glutathione synthesis rate in these cells.   "
210739|NCT00607074|"     This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic     treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.   "
210740|NCT00607087|"     Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart     and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or     infusion set occlusion.      Main Secondary objectives:      To compare insulin glulisine, insulin aspart and insulin lispro on:        -  Unexplained hyperglycemia        -  Infusion set occlusion        -  Hypoglycemic episodes,7-point blood glucose profiles        -  Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis        -  Time to change the infusion set        -  HbA1c (Glycosylated hemoglobin)        -  Overall safety: incidence of adverse events   "
210741|NCT00607100|"     The purpose of this study is to compare the abilities of high-speed,high-resolution (HR)     optical coherence tomography (OCT) and Stratus OCT for detection of retinal nerve fiber layer     (RNFL) loss in eyes with band atrophy (BA) of the optic nerve.   "
210742|NCT00607113|"     Primary Objectives:        -  To determine the effect of Avastin on tumor blood flow as determined by functional          computed tomography (CT) in patients with low or intermediate grade neuroendocrine          carcinoma.        -  To determine the effect of RAD001 on tumor blood flow as determined by functional CT in          patients with low or intermediate grade neuroendocrine carcinoma.        -  To determine the effect of adding the second agent (Avastin or RAD001) to the first          agent (RAD001 or Avastin) on tumor blood flow as determined by functional CT      Secondary Objectives:        -  To determine the clinical activity (objective response rate and progression free          survival duration) of Avastin and RAD001 in patients with low or intermediate grade          neuroendocrine carcinoma.        -  To determine the biochemical response rate of Avastin and RAD001 in patients with low or          intermediate grade neuroendocrine carcinoma.        -  To determine the safety and tolerability of Avastin and RAD001 in patients with low or          intermediate grade neuroendocrine carcinoma.   "
210743|NCT00607126|"     Locomotor training is a new exercise modality that emphasizes task specificity to promote     learning and neural plasticity. It has been reported to improve walking in patients with     stroke, spinal cord injury and cerebral palsy. In this study, 40 patients with impaired     ambulation due to Multiple Sclerosis will be randomized to receive 36 sessions of either     locomotor training or an standard resistive exercise intervention.The locomotor training will     be accomplished via a robotic device, the Lokomat, which will move the patient's legs on a     treadmill while they are suspended in a harness.   "
210744|NCT00607139|"     The primary objective of this study will be to compare the glucose level at which     counter-regulatory hormone responses occur during hypoglycemia in young children with     diabetes, with the glucose level counter regulatory hormone responses that occur in older     children with diabetes.   "
210745|NCT00607152|"     Primary:      To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related     hyperuricemia in Chinese patients with leukemia or lymphoma.      Secondary:      To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients     stratified according to disease (leukemia or lymphoma ).   "
210746|NCT00611286|"     The duration of dual antiplatelet treatment (i.e. asprin and clopidogrel) after drug-eluting     stent implantation is highly debated. This study will evaluate the value of extending such     treatment up to 2 years after the procedure as compared to conventional treatment according     to our national health institute guidelines (i.e. minimum 1 month after bare metal stent and     6 months after drug-eluting stent) on the composite endpoint of death, MI or stroke.   "
210795|NCT00611923|"     This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual     dysphoric disorder.   "
210749|NCT00611325|"     Primary Objective To estimate 6-month progression free survival probability of patients with     recurrent glioblastoma multiforme treated with bortezomib plus Avastin. This efficacy     assessment will be made separately among patients on enzyme-inducing anti-epileptic drugs and     non enzyme-inducing anti-epileptic drugs.      Secondary Objectives To evaluate safety & tolerability of bortezomib plus Avastin among     patients with recurrent malignant glioma.      To evaluate radiographic response, progression free survival & overall survival of patients     with recurrent malignant glioma treated with bortezomib plus Avastin   "
210750|NCT00611338|"     This research study will examine the usefulness of groups in reducing stress and helping     individuals with HIV to stay healthy and avoid problems associated with sexually transmitted     diseases. We hope to discover whether being in a group is effective in reducing     stress-related symptoms and promoting healthy behaviors.   "
210751|NCT00611351|"     RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell     transplant helps stop the growth of cancer cells and helps stop the patient's immune system     from rejecting the donor's stem cells. When certain stem cells from a donor are infused into     the patient they may help the patient's bone marrow make stem cells, red blood cells, white     blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune     response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after     the transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving busulfan together with     cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in     treating patients with hematologic cancer.   "
210752|NCT00611364|"     Physical therapy for hipertensive elderly: effects in the physical activity and exercise     adherence.      Introduction: The arterial hypertension (AH) is a clinical syndrome characterized by blood     pressure ≥ 140/90mmHg. Practical of physical activity (PA) and/or physical exercise (PE) is     one of the modalities of not farmacological treatment. Hypertensive aged not adhere to this     recommendation for presenting factors that make it difficult this practical. Objective: to     verify if physical therapy (PT) treatment can improve the AF and EF adhesion of hypertensive     aged. Methods: The sample was composed by 43 hypertensive aged of Arterial Hypertensive     League of the Federal University of Goiás. Of these, 30 had remained in the study and had     been randomized in study group (SG) (16 patients) and control group (CG) (14 patients). SG     was submitted of the PT treatment and participated of educative meetings, the CG only     participated of the meetings. To evaluate adhesion to the AF was used the pedometer and EF     was used a questionnaire of open and closed questions, six minute walk test (6`WT) and     ergometric test (ET).   "
210953|NCT00613821|"     The purpose of this study is to examine the effect of lidocaine (a numbing medication) inside     the uterus on patient pain during an early abortion, compared to the paracervical block     (lidocaine injected on either side of the cervix).   "
210753|NCT00611377|"     Delirium is rather common among patients in Intensive Care Units (ICU), while little is known     about its incidence in ventilator-dependent patients transferred to a Weaning Center (WC),     once in a phase of clinical stability. We will prospectively evaluate for the presence of     delirium all the ventilator-dependent patients admitted to our WC over a period of two years.     They will be monitored using the Intensive Care Delirium Screening Checklist (ICDSC),     previously validated in the ICU setting. This evaluation is based on a score based on 8 items     obtained with a simple examination by the attending physician. The final sum generates a     score considered normal (0-1), borderline (2-3) and pathologic (>4). All the patients, except     those with normal score, will also be evaluated by a psychiatrist, using the Diagnostic     Manual of Mental Disorders (DSM-IV), considered the gold standard. The score will be assessed     at patient's admission, at mid-hospital stay and at discharge.   "
210754|NCT00611390|"     This randomized, double blind, parallel group study, compared the efficacy of spray     containing aromatic essential oils of some herbal plants, against placebo in the treatment of     patients with acute viral Laryngitis or Tracheitis.      Study objectives: Primary to demonstrate a hoarseness or cough relief within 20 minutes after     first administration of treatment with the spray.      Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and     signs comparing baseline therapy from the beginning to the end of 3 days treatment   "
210755|NCT00611403|"     This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion     administered twice daily following LASIK surgery   "
210756|NCT00611416|"     The aim of this study is to elucidate the role of specific catechins, a mixture of catechins     and caffeine in relation to weight control with particular emphasis on energy metabolism and     fat oxidation.   "
210757|NCT00611429|"     This study will develop and test the effectiveness of an educational and supportive     counseling program called Preparing Patients to Start Antiretroviral Therapy in helping     people with HIV make informed decisions about their health care.   "
210758|NCT00611442|"     The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by     the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the     prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and     size of polyps detected on examination.   "
210759|NCT00611455|"     This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a     duration of 24 weeks, followed by a 120 week Open-label Period. the primary purpose of the     study is to demonstrate the efficacy of ofatumumab in reducing clinical signs and symptoms in     adult RA patients after a single course of ofatumumab.   "
210760|NCT00611468|"     The purpose of this research study is to determine the best dose of the combination of two     approved drugs, intravenous topotecan and oral erlotinib.   "
210761|NCT00611481|"     Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures     of balance, and secondary outcomes of gait, physical performance, Unified Parkinson's Disease     Rating Scale, Falls, muscle strength.   "
210762|NCT00611494|"     The purpose of the study is to assess the gastrointestinal tolerability of EC-MPS compared to     MMF in maintenance transplant patients on a calcineurin inhibitor regimen, who require MMF     dose reductions of 25% or more due to GI complications. The tested hypothesis is that the     EC-MPS treatment is superior to the MMF therapy in terms of tolerability and that patients on     the EC-MPS formulation will be able to tolerate higher doses compared to those on MMF.   "
210763|NCT00611507|"     This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the     efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in     advanced colorectal cancer   "
210764|NCT00611520|"     Under daily routine conditions and without any intervention by the sponsor regarding the     selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non-     medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians     (i.e. pneumologists and internists) are asked to document relevant data related to the     budesonide/formoterole therapy in patients with COPD.   "
210765|NCT00611533|"     The purpose of this study is to examine the efficacy of atomoxetine (ATX) treatment for the     mild to moderate cognitive disturbances frequently experienced by women during the menopause     transition. In addition, we seek to determine, using the Brown Attention Deficit Disorder     Scale (BADDS), whether and to what degree peri- and early post-menopausal women experience     cognitive disturbances which overlap with the impairments of executive function     characteristic of adults with attention deficit disorder (ADHD).   "
210766|NCT00611546|"     In an effort to decrease the load of peroxides in TPN solutions, multiple studies examined     different strategies such as photo-protection, adding multivitamins to the lipid emulsion     rather than to the dextrose-amino acid admixture, and adding antioxidants such as glutathione     to the TPN solution. However, the role of trace elements as antioxidants, and their     interaction with light have not been studied. Also, the impact of TPN-related oxidants on     clinical morbidities has not been addressed. Therefore, we aimed in this study of preterm     infants to evaluate the role of different components of TPN on urinary peroxides and to     examine the biochemical and clinical effects of light protection.   "
210767|NCT00611559|"     The new formulation administered as a 4th consecutive dose will be compared to the current     formulation of the vaccine in this partially double blind study.      The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study     will be open with respect to the DTPa-HBV-IPV group.   "
210768|NCT00611572|"     This study investigates the interactions between NMDA (N-Methyl-D-aspartic acid) antagonism     and GABA (gamma-aminobutyric acid) system as it relates to cognitive function assessed by     ERPs (event-related potentials) in healthy volunteers.   "
210769|NCT00611585|"     The purpose of this study is to meet a PMA condition of approval of the BHR System. The study     will evaluate the long term safety and effectiveness of the BHR system in patients with     non-inflammatory and inflammatory arthritis.   "
210834|NCT00612430|"     Primary Objective to estimate 6-month progression free survival probability of patients with     recurrent malignant glioma treated with Etoposide + Bevacizumab.      Secondary Objectives To evaluate safety & tolerability of Etoposide + Bevacizumab among     patients with recurrent malignant glioma (RMG).      To evaluate radiographic response, progression free survival & overall survival of patients     with recurrent malignant glioma treated with Etoposide + Bevacizumab.   "
210770|NCT00611598|"     The purpose of this study is to help us better understand the cellular changes that may lead     to the development of lung cancer. We want to compare people with a second primary lung     cancer with those who have only a first primary lung cancer. We hope to use the information     obtained in this study as the basis for future studies and will not regard the results from     this study as final.      We will analyze your blood cells and DNA to measure the changes in several genes that we     believe may be involved in lung cancer. We also want to evaluate the capacity for your DNA to     repair itself.   "
210771|NCT00611611|"     This protocol tests whether changes in BLyS or IFN can be detected in a normal immune     response to a vaccine and, if so, whether the response differs between those with lupus and     healthy controls.   "
210772|NCT00611624|"     The purpose of this study is to determine if Mammosite Catheter optimization using multiple     dwell position delivery decreases skin toxicity over historically reported skin toxicity with     the single dwell delivery method.   "
210773|NCT00611637|"     The purpose of this study is to determine the safety and feasibility of CMV specific, T cell     adoptive immunotherapy in patients who have undergone allogeneic stem cell transplantation     for malignant disease.   "
210774|NCT00611650|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of Polyphenon E, a substance found in green tea, may keep cancer from forming in current or     former smokers with bronchial dysplasia.      PURPOSE: This randomized phase II trial is studying the side effects and how well green tea     extract works in treating current or former smokers with bronchial dysplasia.   "
210775|NCT00611663|"     The aim of this study is to compare the immunological efficacy of two pneumococcal     vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with     corticosteroids associated or not with other immunosuppressive drugs : 1) a prime-boost     strategy using vaccination with conjugate vaccine (Prevenar®) at week 0 and Poly Saccharidic     vaccine (Pneumo23®) after 6 months (W24)2) compared to the standard vaccination with Poly     Saccharidic vaccine (Pneumo23®) at W24 after placebo at W0   "
210776|NCT00611676|"     This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may     receive Venlafaxine or placebo during the course of the trial. All subjects will, in fact,     receive placebo for the first two weeks. All subjects will then be placed on 150-225 mg per     day of venlafaxine. Primary outcome assessment will compare pain intensity at 2 weeks (after     placebo) to that at 12 weeks (after 10 weeks of Venlafaxine treatment).      Study Hypothesis:      In subjects who continue to have activity-limiting osteoarthritis pain after treatment with     acetaminophen or non-steroidal anti-inflammatory agents, 150-225 mg Venlafaxine per day over     10 weeks will provide significant additional pain relief over that achieved with placebo     (more than 30% reduction after Venlafaxine treatment).   "
210777|NCT00611689|"     In this phase I study, the investigators will determine the maximum tolerated doses of     imatinib and PTK/ZK administered in two different dose schedules. Due to the different     mechanisms of action and the minimally-overlapping toxicity profiles of these two novel oral     agents, it is hoped that a combination regimen incorporating both compounds will produce     increased activity without enhanced toxicity. After completion of this phase I study, the     investigators propose a follow-up phase II study in patients with previously treated     metastatic renal cell cancer - where VEGF and PDGF appear to play important roles in the     malignant phenotype - to determine the antitumor efficacy of the recommended dose of this     combination regimen.   "
210778|NCT00611702|"     Doctors have had success preventing certain types of kidney transplant rejection by     suppressing the immune system. However, an individual's genetic make-up and the strength of     an immune response to a transplant may also determine whether a transplanted organ is     rejected. The purpose of this study is to look at the genetic profile and immune response of     people who have had kidney transplants and to correlate the findings with kidney transplant     rejection episodes. Donor genetic profiles will also be studied and correlated with the     recipient's information.   "
229867|NCT00860964|"     The purpose of this trial is to study the efficacy and safety of low dose of estradiol     valerate in the prevention and treatment of postmenopausal osteoporosis.   "
210779|NCT00611715|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells.     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving letrozole together with erlotinib may kill more tumor cells.      PURPOSE: This phase II clinical trial is studying how well giving letrozole together with     erlotinib works in treating postmenopausal women with estrogen receptor-positive and/or     progesterone receptor-positive locally recurrent or metastatic breast cancer.   "
210780|NCT00611728|"     Primary Objectives To determine maxi tolerated dose & dose limiting toxicity of SU011248 +     Irinotecan in recurrent MG pts not on EIAEDs To characterize safety & tolerability of     SU011248 + Irinotecan among pts w recurrent MG Secondary Objectives To evaluate     pharmacokinetic profile of SU011248 & Irinotecan when co-administered in pts w MG To evaluate     anti-tumor activity of SU011248 + Irinotecan   "
210781|NCT00611741|"     This study is designed to test the hypothesis that plasma osmolality is linked with cortical     glutamate concentrations in the brain. It also investigates whether the glutamate response in     schizophrenia is enhanced compared to healthy controls.   "
210782|NCT00611754|"     To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU)     in patients with advanced inoperable or metastatic head and neck cancer and to investigate     the safety profile of this regimen in the above indication and consider other criteria of     efficacy (clinical benefit, survival)   "
210783|NCT00611767|"     This Project will explore the hypothesis that individuals with a family history positive for     alcohol dependence (without any current Axis I disorder, except nicotine dependence),     experience an alteration in the reward valence (balance of positive and negative effects)     of the GABAA receptor agonist barbiturate (thiopental) compared to family history negative     age-matched subjects. Further, variation in genes involved in brain GABA function may     influence the risk for alcoholism by altering a component of the discriminative stimulus     effects of ethanol.   "
210954|NCT00613834|"     The purpose of this study is to assess the level of pain women experience with an Essure     procedure and the effect that lidocaine might have on that pain. We will also assess the     absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.   "
210784|NCT00611780|"     The objective of this study is to compare radiation dose of a 100kV scan protocol to the     standard 120kV scan protocol. We hypothesize that the 100kV scan protocol is associated with     a reduction in dose estimates of at least 20%, while the diagnostic image quality is not     inferior.      Secondary endpoints of the study include quantitative image quality parameters, diagnostic     accuracy for 120 vs.100kV studies compared to invasive angiography in patients who underwent     subsequent invasive coronary angiography   "
210785|NCT00611793|"     PTK787/ZK222584 is an orally active inhibitor of VEGF-R tyrosine kinases. Bevacizumab is an     intravenous humanized monoclonal antibody directed against vascular endothelial growth     factor. By binding to VEGF, bevacizumab blocks VEGF-A receptor binding. Due to the different     mechanisms of action and the non-overlapping toxicity profiles of the two agents, it is hoped     that a combination regimen incorporating both compounds will produce increased activity     without enhanced toxicity.   "
210786|NCT00611806|"     This study will evaluate the effectiveness of folate and B12 supplementation in reducing     negative symptoms in people with schizophrenia.   "
210787|NCT00611819|"     The rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment.      Combination of Peg interferon and Ribavirin is the best treatment because it improve the     compliance of treatment.      In APRICOT study genotypes 2 and 3 patients received 48 weeks and the rates of end of     treatment response was 64% and the sustained virological response (24 weeks after the end of     treatment) 62%.      In mono-infected patients trials showed there are not differences in the sustained     virological response between 24 and 48 weeks of treatment, however exit the doubt concerning     the different kinetic viral in HIV-HCV co-infected patients and this could be related with a     lost of profit with a shorter duration of treatment, only 24 weeks.      In this study we woud like to evaluate if 24 weeks of treatment in HIV-HCV co-infected     patients genotype 2 or 3 will have the same rate of clearance of virus at the end of     follow-up period.   "
210788|NCT00611832|"     Researchers are developing and experimentally evaluating two variants of a 10-episode, brief     (12 minutes per episode), infotainment-style television series targeted at parenting     practices, to determine the potential value of television for bringing evidence-based     parenting practices to parents. The study compares an information-only version of the     television series against an enhanced version that is designed to actively promote parents'     adoption of the targeted strategies. Both versions of the series are compared against a     waitlist control group. The media series is derived from the Triple P Positive Parenting     Program.   "
210789|NCT00611845|"     This is a special access protocol that will allow physicians access to aprotinin during the     temporary marketing suspension. The program will provide aprotinin for treatment of surgical     patients undergoing coronary artery bypass graft (CABG) surgery requiring cardiopulmonary     bypass (CPB) who are at increased risk of bleeding and transfusion when, in the opinion of     the treating physician, the patients require it, there is no acceptable alternative therapy,     and when there is a clearly favorable benefit-risk for the drug in that individual patient.   "
210790|NCT00611858|"     The standard treatment for rectal cancer is to receive the chemotherapeutic drug     5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal     cancer. This is known as neoadjuvant chemoradiotherapy. The purpose of this research study is     to determine if Cetuximab improves the benefits of neoadjuvant chemoradiotherapy when given     with 5-FU and radiation therapy. The epidermal growth factor (EGF) receptor, which is found     in rectal cancer, is a specific part of the cancer that is felt to encourage tumor growth.     Cetuximab targets and blocks the EGF receptor and has been shown to be safe and effective in     treating colorectal cancer and head and neck cancers.   "
210791|NCT00611871|"     The purpose of this investigation is to see if propranolol will reduce the     psychophysiological hyperactivation associated with memories of combat stress in Veterans     with Posttraumatic Stress Disorder.   "
210792|NCT00611884|"     This trial is conducted in Africa, Asia and North America. The aim of this trial is to     compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin     glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.   "
210793|NCT00611897|"     This study tests the hypothesis that extrasynaptic mechanisms are critically linked with     cognitive effects of NMDA antagonism as evidenced by event-related potentials (ERPs) in     healthy humans.   "
210796|NCT00611936|"     A total of 18 healthy volunteers will participate in this four-week, within-groups,     double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day     washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or     placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After     receiving medication or placebo for three days, subjects will have a 6-hour laboratory     session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg     maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and     subjective outcome measures will be obtained during the experimental sessions. Subjects will     then have a 4-15 day washout period and will be crossed over to the alternative treatment for     Phase II.   "
210797|NCT00611949|"     The purpose of this study is to determine which component of an artificial geranium oil helps     to reduce your neuropathy pain.   "
210798|NCT00611962|"     To evaluate the efficacy of the oxaliplatin-paclitaxel combination i.e. evaluation of tumor     response rate using World Health Organization/Union Internationale Contre le Cancer     (WHO/UICC) and Indianapolis tumor marker (human chorionic gonadotropin [hCG], alpha     fetoprotein [AFP]) criteria in metastatic germ cell cancer patients   "
210799|NCT00611975|"     This study will evaluate the effect of antidepressants on sex hormone levels in women and if     the potential changes in sex hormone levels are related to sexual side effects.   "
210800|NCT00611988|"     We are conducting a clinical research trial to determine the role of self-managed walking     therapy to improve walking ability in patients with diabetes mellitus and peripheral arterial     disease (PAD). PAD, commonly referred to as poor circulation in the legs, is a very common     disease in patients with diabetes mellitus. For patients with PAD, there is a significant     risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy     but the traditional methods for the delivery of this treatment have required frequent visits     to a university or hospital-based site. We will address the role of self-managed walking     program, to be conducted at or near the home, to improve limb function.   "
210803|NCT00612027|"     Under daily routine conditions and without any intervention by the sponsor regarding the     selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non-     medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians     (i.e. general practitioners and internists) are asked to document relevant data related to     esomeprazole therapy in patients with gastrointestinal disorders. Patients with acid     associated gastrointestinal symptoms can be included.   "
210804|NCT00612040|"     This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of     this trial is to compare two NN1250 (insulin degludec) formulations with each other and with     insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.   "
210805|NCT00612053|"     The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational     study will appraise the prevalence, management strategy, and prognosis of unprotected left     main coronary artery disease in Italy.   "
210806|NCT00612066|"     RATIONALE: Rosiglitazone may help pituitary tumor cells become more like normal cells, and to     grow and spread more slowly.      PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients     with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease).   "
210807|NCT00612079|"     This study aims to further validate and extend our previous findings insofar that the effect     of the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole on sensorimotor gating     processes and its relationship to cognitive performance shall be explored.   "
210808|NCT00612092|"     The objective of this study is to compare radiation dose of a standard spiral scan with the a     new sequential scan protocol. We hypothesize that the sequential scan protocol is associated     with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not     inferior.      Secondary endpoints of the study include quantitative image quality parameters, diagnostic     accuracy for spiral versus sequential studies compared to invasive angiography in patients     who underwent subsequent invasive coronary angiography.   "
210809|NCT00612105|"     The purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing     pain associated with post-herpetic neuralgia.   "
210810|NCT00612118|"     This study is an 8 day, randomised, double blind, 2-way crossover trial of repeat doses of     intranasal GSK256066 and azelastine hydrochloride in the Vienna Challenge Chamber in subjects     with seasonal allergic rhinitis (SAR). Laboratory safety assessments, 12-lead     electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the     study. Nasal examination, symptom scores, and allergen challenge assessments will also be     performed at various time points throughout the study.   "
210811|NCT00612131|"     I Hypothesis:        1. Simulation-based training in maximal barrier precaution technique during central venous          catheter (CVC) placement is superior to general videotape-based training        2. Baseline performance in maximal barrier precaution technique of PGY 2 and 3 Medical          residents, certified in CVC placement, is poor        3. PGY 2 and 3 medical residents have low self-perceived confidence in mastering maximal          barrier precaution technique during central venous catheter (CVC) placement        4. PGY 2 and 3 medical residents undergoing simulation-based training in maximal barrier          precaution technique during central venous catheter (CVC) placement have good recall          after 3 months   "
210812|NCT00612144|"     The aim of this study is to compare the efficacy and safety of early combination therapy with     Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM     inadequately controlled by prior monotherapy with metformin.   "
210813|NCT00612157|"     The purpose of this study is to assess the efficacy of Eszopiclone in improving short and     intermediate-term compliance with continuous positive airway pressure (CPAP) in patients     newly diagnosed with obstructive sleep apnea (OSA).   "
210814|NCT00612170|"     This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving     the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful     treatment effects in fibromyalgia, based on pain and functional endpoints.   "
210815|NCT00612183|"     The purpose of this study is to assess the antitumor effects and safety of bendamustine     hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or mantle     cell lymphoma.   "
210816|NCT00612196|"     Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody     directed against FVIII, versus placebo in healthy male volunteers.   "
210817|NCT00612209|"     This is an open label, single arm, dose escalation study of ARQ 197 in patients with advanced     solid tumors.   "
210818|NCT00612222|"     Background:        -  Melanoma antigen recognized by T-cells (MART)-1 is a protein present in melanoma cells.        -  An experimental procedure developed for treating patients with melanoma uses the          anti-MART-1 F5 gene and a type of virus to make special cells called anti-MART-1 F5          cells that are designed to destroy the patient's tumor. These cells are created in the          laboratory using the patient's own tumor cells or blood cells.        -  The treatment procedure also uses a vaccine called plaque purified canarypox vector          (ALVAC) MART-1, made from a virus that ordinarily infects canaries and is modified to          carry a copy of the MART-1 gene. The virus cannot reproduce in mammals, so it cannot          cause disease in humans. When the vaccine is injected into a patient, it stimulates          cells in the immune system that may increase the efficiency of the anti-MART-1 F5 cells.      Objectives:      -To evaluate the safety and effectiveness of anti-MART-1 F5 and the ALVAC vaccine in treating     patients with advanced melanoma.      Eligibility:      -Patients 18 years of age with metastatic melanoma for whom standard treatments have not been     effective.      Design:        -  Patients undergo scans, x-rays and other tests and leukapheresis to obtain white cells          for laboratory treatment.        -  Patients have 7 days of chemotherapy to prepare the immune system for receiving the          anti-MART-1 F5.        -  Patients receive the ALVAC vaccine, anti-MART-1 F5 cells and interleukin-2 (IL-2) (an          approved treatment for advanced melanoma). The anti-MART-1 F5 cells are given as an          infusion through a vein. The vaccine is given as injections just before the infusion of          anti-MART-1 F5 cells and again 2 weeks later. IL-2 is given as a 15-minute infusion          every 8 hours for up to 5 days after the cell infusion for a maximum of 15 doses.        -  After hospital discharge, patients return to the clinic for periodic follow-up with a          physical examination, review of treatment side effects, laboratory tests and scans every          1 to 6 months.   "
210819|NCT00612235|"     This study is being done to determine if there are differences in mood during the menstrual     cycle among women with epilepsy who take various different antiepileptic drugs and women     without epilepsy.   "
210820|NCT00612248|"     Forty participants were enrolled in a randomized, controlled clinical trial to evaluate the     effectiveness of a functional thumb splint for trapeziometacarpal OA in the dominant hand.   "
210849|NCT00612625|"     The ability of glucagon-like peptide 1 to enhance beta-cell responsiveness to I.v. glucose is     impaired in patients with type 2 diabetes mellitus compared with healthy individuals. We     investigated whether 4 weeks of near-normalisation og blood glucose improves the potentiation     of glucose-stimulated insulin secretion by GLP-1   "
210821|NCT00612261|"     Branch retinal vein occlusion (BRVO) is a common retinal vascular disease occurring in a     significant number of individuals older than 50 years.The most common cause of visual     disturbance in BRVO patients is macular edema, which has been reported in 60% of patients.     Macular grid laser photocoagulation has been shown to be effective in the treatment of     macular edema arising from BRVO. Some eyes are resistant to conventional grid laser     treatment, and the conventional treatment is not useful in patients with intraretinal     hemorrhages that may interfere with laser photocoagulation. Moreover, several studies have     shown that conventional grid laser treatment for macular edema may be associated with     complications.      Intravitreal triamcinolone acetonide (IVTA) injection has recently been reported to be     effective in the treatment of macular edema of various etiologies.On the other hand,     arteriovenous sheathotomy is a surgical method suggested for treatment of macular edema in     BRVO patients, and has been reported to be efficacious in patients refractory to conventional     focal or grid laser macular photocoagulation.Both treatment modalities have been reported to     be associated with reductions in central macular thicknesses and improved visual acuities.      The purpose of the study is to compare the efficacies of arteriovenous (AV) sheathotomy and     intravitreal triamcinolone (IVTA) injection in the treatment of macular edema associated with     branch retinal vein occlusion (BRVO).   "
210822|NCT00612274|"     The primary objective of this trial is to study the safety and efficacy of a novel regimen of     sirolimus, tacrolimus and methotrexate as prophylaxis against acute graft versus host disease     (GVHD) in recipients of mismatched unrelated donor stem cell grafts. Methotrexate is     administered in a low dose format of 5mg/m2 on days +1,3 and 6 only.   "
210823|NCT00612287|"     The purpose of this study is to develop and pilot test clinical guidelines for the use of     buprenorphine for the treatment chronic pain among patients with substance abuse histories.     Buprenorphine, an opioid medication, holds promise as a treatment of chronic pain because,     compared to most other opioid analgesics, it has a high safety profile, a low level of     physical dependence, and mild withdrawal symptoms on cessation. Moreover there are promising     reports from Europe of its use as a skin patch to treat chronic pain as well as clinical     reports in the U.S. that it may be effective when used sublingually (placed under the     tongue). This study will test the sublingual formulation.   "
210824|NCT00612300|"     The objective of this study is to investigate the effects of an automatic gait trainer     (Lokomat) handled by physical therapists compared with categorized gait training by physical     therapists in ambulatory stroke patients. Gait speed, gait distance and gait symmetry are     used to evaluate study effects.      Hypotheses: 1) The Lokomat improves stroke patients gait speed, distance and symmetry more     than categorized gait training.   "
210825|NCT00612313|"     This study will compare the effectiveness of fluoxetine alone with the effectiveness of     fluoxetine with cognitive behavioral therapy in increasing recovery and preventing relapse in     youth with major depressive disorder.   "
210826|NCT00612326|"     The purpose of this study is to to find out if the MRI and PET scans can truly stage patients     with bladder cancer. Both scans use newer ways to find out if your disease has grown beyond     the bladder. The radioactive tracer used for the PET scan is called C-11 Acetate. We want to     see if PET scan will be able to take a picture of the inside of your body that is better than     other scans such as the CT scan and MRI. Therefore, the findings of the PET scan will be     compared with other imaging studies as well as the surgical findings.   "
210827|NCT00612339|"     Primary objective- To determine efficacy of Avastin, 10 mg/kg every other week, in     combination with standard 5-day temozolomide in terms of response rate.      Secondary objective- To determine safety of Avastin & Temozolomide in unresectable     glioblastoma patients   "
210828|NCT00612352|"     The proposed study is the first to explore the contribution of brain glutamate systems, a     major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study     may lead to an enhanced understanding of the underlying neurobiological mechanism in high     risk individuals that may lead to the transition from moderate to excessive use of alcohol.   "
210829|NCT00612365|"     Obesity is a growing public health concern, with approximately 31% of Americans considered     obese. The link between abdominal obesity and cardiovascular disease (CVD) has been well     established, but the effect of distinct types of abdominal fat tissue on CVD risk is not well     known. The rate of obesity and the distribution of abdominal fat differ with age, sex, and     ethnicity. These differences may have important implications for determining ethnic-specific     relationships between abdominal body composition (ABC), inflammation, and CVD events. This     study will evaluate the association between measures of abdominal fat, CVD risk, and     inflammation in terms of ethnicity-, sex-, and age-specific differences.   "
210830|NCT00612378|"     The purpose of this research study is to evaluate the immediate effectiveness of the GFX™     device in reducing the furrows (deep frown lines) between eyebrows (glabellar region).   "
210831|NCT00612391|"     A prospective randomized clinical trial is proposed to compare the plate fixation of proximal     humerus fractures using a minimally invasive lateral approach and the traditional anterior     approach.Forty five patients will be assigned to each approach (total of 90 patients) and     will be assessed 7 times over a two-year period. The trial's primary objectives will be to     demonstrate the efficacy of the plating technique in terms of speed of recuperation of     function. The Quick DASH will be used for evaluation of function.The study will also examine     secondary end-points of pain, range of motion, esthetic satisfaction and radiographic     outcome, as assessed by the components of the Constant Score3,4, SF-12V2 Questionnaire, and     Patient Scare Assessment Scale Questionnaire. Furthermore, the assessment of safety will be     based on the rates of all reported complications and adverse events at 2 years   "
210832|NCT00612404|"     Under daily routine conditions and without any intervention by the sponsor regarding the     selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non-     medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians     (i.e. gastroenterologists) are asked to document relevant data in patients with     gastrointestinal disorders.   "
210833|NCT00612417|"     Single administration of recombinant FVIII/placebo in healthy male subjects who have been     treated with a single dose of anti-factor VIII antibody, TB-402   "
210985|NCT00616473|"     The purpose of this study is to examine key organizational structures and processes     (leadership, teamwork, communication, palliative care) and their impact on the quality of     end-of-life care for dying residents and their family members.   "
210835|NCT00612443|"     The purpose of this study is to evaluate the effectiveness of Healing Touch to improve     health-related quality of life in women with breast cancer receiving radiation therapy.      Research Hypothesis Healing Touch significantly improves health-related quality of life when     compared to a placebo treatment, among women receiving radiation therapy for treatment of     breast cancer.   "
210836|NCT00612456|"     This is a 28 day study to evaluate the pharmacodynamic effect of pazopanib eye drops on the     central retinal thickness of AMD patients   "
210837|NCT00612469|"     The aim of the present study was to compare salivary MS levels in four different groups of     children with caries, that have been submitted to intraoral topical treatment with either     1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days.     This clinical trial was designed to test two different hypotheses. First, that topical     vancomycin would be more effective than chlorhexidine and sodium fluoride in salivary MS     reduction. Secondly, a 6-day antimicrobial treatment with either one of these agents would     produce a long lasting MS suppression, dispensing repeated antibacterial treatments.   "
210838|NCT00612482|"     Our primary goal is to conduct a pilot study of the effects of a new potential strategy for     youth substance abuse prevention - science-based drug education integrated into the high     school science curriculum. Through this pilot study we propose to: (1) demonstrate that this     new strategy shows promise, and (2) estimate the effect size for the intervention.   "
210839|NCT00612495|"     To determine the efficacy (response rate [RR], time to progression and survival) of     oxaliplatin as a single agent and oxaliplatin in combination with 5 FU in patients with     advanced/metastatic endometrial cancer pretreated with one prior chemotherapy regimen     containing cisplatin (CDDP) or carboplatin and to define the safety profile of each arm of     the above mentioned regimens in these patients   "
210840|NCT00612508|"     The purpose of this study is to help determine if the route by which women receive hormonal     contraception causes different changes to occur in the lining of the vagina. The     investigators plan to compare an oral route (taking birth control pills) with a vaginal route     (using a vaginal ring).   "
210841|NCT00612521|"     Myocardial damage occurs in up to 40% of cases when sensitive biomarkers are measured after     coronary artery stenting. Such events have been associated with poor outcomes both at 30 days     and long term. The cause of such damage is multi-factorial and includes distal propagation of     atheromatous and thrombotic debris and the subsequent infiltration of the microcirculation     with inflammatory cells. Individually or together these events can occlude the     micro-circulation and lead impaired blood flow to heart muscle.      The vasodilator adenosine is commonly used in cases of impaired flow in an endeavor to     improve flow rate and limit myocardial damage. Unfortunately the efficacy of this therapy is     limited. More recently, there have been clinical studies looking at the administration of     adenosine before any potential damage by ballooning or stenting, in an effort to avoid poor     distal flow post procedure and thus limit any myocardial damage. Although small numbers of     subjects have been included in these trials, there have been encouraging preliminary data.      The aim of this study is to assess whether the use of intra-coronary adenosine given directly     into the target coronary artery prior to stenting can reduce the incidence of myonecrosis     (heart muscle damage)over placebo. We also aim to assess whether this translates to better     outcomes at 30 day follow up.   "
210842|NCT00612534|"     The purpose of this study is to evaluate three different dosage strengths of sublingual     ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of     post-operative pain in subjects following total knee replacement surgery. We hypothesize that     subjects receiving placebo will have poor pain relief and will drop out of the study sooner     and more often than the ARX-F01-treated subjects.   "
210843|NCT00612547|"     The purpose of this study is to assess the feasibility, the acceptability and the     effectiveness of the use of the Artesunate + Amodiaquine Fixed Dose Combination for the home     management of presumed malaria in Malagasy children by the community-based service providers.   "
210844|NCT00612560|"     The proposed study plans to examine the effect of flaxseed consumption, a phytoestrogen rich     food, compared to aromatase inhibitors as a complementary approach to treating estrogen     receptor positive breast cancer, as well as the effect of combined flaxseed and aromatase     inhibitor therapy on breast cancer treatment. Because of the increasing use of both     complementary and alternative approaches to treatment, and the use of aromatase inhibitors in     the treatment of breast cancer, the proposed study has potential to provide important     clinical information about the effect of foods high in phytoestrogens on a common endocrine     therapy used in breast cancer.   "
210845|NCT00612573|"     Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety     and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the     Investigator's Global Assessment (IGA) score and the absolute change from baseline in     inflammatory lesion count in patients with moderate to severe facial acne vulgaris.     Additionally, the absolute change from baseline in non-inflammatory and total lesions of the     active study medication to placebo will be evaluated.   "
210846|NCT00612586|"     This study will evaluate the addition of enzastaurin to 5-FU(5-fluorouracil)/LV (leucovorin)     plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line     therapy consisting of FOLFOX (5-FU/LV + oxaliplatin) or FOLFIRI(5-FU/LV + irinotecan), plus     bevacizumab in patients with Metastatic Colorectal Cancer.   "
210847|NCT00612599|"     This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics     and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin     aspart 70 three times a day in non-obese and obese with type 2 diabetes.   "
210848|NCT00612612|"     Obatoclax may stop the growth of chronic lymphocytic leukemia by blocking blood flow to the     cancer and by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. Giving obatoclax together with fludarabine and rituximab may kill more     cancer cells. This phase I trial is studying the side effects and best dose of obatoclax when     given together with fludarabine and rituximab in treating patients with B-cell chronic     lymphocytic leukemia.   "
210850|NCT00612638|"     Objectives:      To determine maximum tolerated dose of CPT-11 when administered following Temodar plus     O6-benzylguanine To characterize any toxicity associated w combo of CPT-11 + Temodar plus     O6-BG To observe pts for clinical antitumor response when treated w combo of CPT-11 + Temodar     + O6-BG   "
210851|NCT00612651|"     Objectives:      To determine maximum tolerated dose of farnesyl transferase inhibitor, SCH 66336, when     administered w TEMODAR®.      To characterize any toxicity associated w combo of farnesyl transferase inhibitor, SCH 66336,     & TEMODAR®.      To observe patients for clinical antitumor response when treated with combination of farnesyl     transferase inhibitor, SCH 66336, & TEMODAR®.      To assess pharmacokinetics of SCH 66336 for patients on & not on enzyme inducing     antiepileptic drugs.   "
210852|NCT00612664|"     The main purpose of this study is to estimate the proportion of patients with a type of skin     cancer called melanoma who are progression free, (that is, the cancer has not gotten     substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg     or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks   "
210853|NCT00612677|"     The purpose of this study is:        -  To find out if the chemotherapy treatment using Pemetrexed (Alimta) and Oxaliplatin          (Eloxatin) given together will kill the cancer cells in the patient's body and shrink          the size of their tumor. This may allow patients to live longer or decrease the          frequency and/or severity of the symptoms caused by the cancer. Pemetrexed has been          approved by the Food and Drug Administration (FDA) to treat Lung Cancer. Oxaliplatin has          been approved by the FDA for the treatment of Colon Cancer. The combination of these two          drugs has been used to treat patients with Non-Small Cell Lung Cancer in Italy but not          yet in the USA      Other purposes of this study are:        -  To better detail the toxic effects of this chemotherapy combination.        -  To determine whether the level of specific gene and/or gene products (genes are genetic          material that allows cells to make proteins such as enzymes) are useful to predict if          this chemotherapy combination will work or not.   "
210854|NCT00612690|"     This study will evaluate the effectiveness of school- and home-based mental health services     and training modules in supporting learning and behavior in financially disadvantaged     children who live in urban areas.   "
210855|NCT00612703|"     To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when     administered in combination with erlotinib to patients with advanced solid tumors   "
210856|NCT00612716|"     RATIONALE: Giving chemotherapy, such as cyclophosphamide and busulfan, and total-body     irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It     also stops the patient's immune system from rejecting the donor's stem cells. The donated     stem cells from bone marrow or umbilical cord blood may replace the patient's immune cells     and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving methotrexate and cyclosporine after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in     treating patients with previously treated lymphoma, multiple myeloma, or chronic lymphocytic     leukemia.   "
211111|NCT00618163|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam     tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fasting conditions     using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.   "
210857|NCT00612729|"     Visible-light-filtering IOLs are implanted increasingly often in cataract surgery. Several     studies examined the effect of light-filters on contrast and colour vision. However, the     study outcomes were varying. The present study investigated the effect of two light-filtering     IOL on colour perception and contrast acuity using highly sensitive measurement methods.   "
210858|NCT00612742|"     This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center     study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD     in postmenopausal women with at least two points of cardiovascular risk and clinical     diagnosis of Hypoactive Sexual Desire Disorder (HSDD).   "
210859|NCT00612755|"     A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with     peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on     Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions     and the viral clearance was larger than mono-infected patients.      The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus     mono-infected is related with the loss of profited on treatment.      In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates     was only 2%.      The present study want to evaluate is the treatment extent for 24 weeks more in patients     genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the     end of the follow-up period, to prevent relapsed in patients with response at the end of     treatment.      Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200     mg/day of ribavirin during 24 weeks more or control.   "
210860|NCT00612768|"     An open, prospective, multi-center study to evaluate the bioequivalence of     polyvinylpyrrolidone formulations of T.R.U.E. TEST fragrance mix and thimerosal allergens.   "
210861|NCT00612781|"     Blue-light-filtering IOLs are implanted increasingly often in cataract surgery. Several     studies examined the effect of blue-light-filters on contrast and colour vision. However, the     study outcomes were varying. The present study investigated the effect of a     blue-light-filtering IOL on colour perception and contrast acuity using highly sensitive     measurement methods.   "
210862|NCT00612794|"     Exenatide twice daily has been studied in Japanese type 2 diabetes patients. A once-weekly     version of exenatide is currently being evaluated. Study GWBW is the first study of exenatide     once weekly in Japanese patients. This study is designed to evaluate safety and tolerability     of exenatide once weekly in Japanese patients and determine whether the dose selected for US     and European development is appropriate for Japanese patients with Type 2 diabetes.   "
210863|NCT00612807|"     The primary goal of this study is to develop and test a depression-specific marital therapy     tailored for use with older adult populations.   "
211015|NCT00616876|"     A pilot study to test the safety of use of lactulose in preterm infants and to preliminary     assess the hypothesis that lactulose would support the early growth of Lactobacilli in the     stools of premature infants and possibly would also improve nutritional status and decrease     NEC and late-onset sepsis.   "
210864|NCT00612820|"     This is an 8 day, randomised, double blind, 3-way crossover trial of repeat doses of     intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects     with seasonal allergic rhinitis (SAR). Approximately 60 subjects will be selected for     enrolment with the intention of acquiring at least 48 evaluable subjects. Laboratory safety     assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will     be made throughout the study. Nasal examination, symptom scores, nasal lavage, nasal scrape     and allergen challenge assessments will also be performed at various time points throughout     the study.   "
210865|NCT00612833|"     This study will be a randomized, controlled multicenter trial, conducted jointly by the     Indian Council of Medical Research, New Delhi and Family Health International, which will     compare three vasectomy occlusion techniques, all using the no-scalpel vasectomy (NSV)     approach to isolation of the vas:        1. ligation and excision of about 1 cm of the vas, with fascial interposition;        2. intraluminal thermal cautery with excision of about 1 cm of the vas;        3. intraluminal thermal cautery with excision of about 1 cm of the vas combined with          fascial interposition.      A total of 1500 healthy, sexually active men at least 21 years old who have chosen vasectomy     as a means of contraception will be recruited at four to six study sites in India. The     success of the vasectomy procedure will be determined based on semen analysis results. All     men should have semen analyses at 8 and 12 weeks post-vasectomy. All men will be asked to     attend a final visit at 12 months.   "
210866|NCT00612846|"     The aim of the trial is to compare two operations which are used to treat bile duct stones.     The hypothesis of the study is that there is no difference between endoscopic sphincterotomy     followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during     laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.   "
210867|NCT00612859|"     Preclinical and clinical findings indicate that LEV has some anxiolytic potential. There is     reason to believe that compounds with anxiolytic activity may have broad clinical utility     across the anxiety spectrum. This trial was intended to explore LEV's utility in adults with     social anxiety disorder.   "
210868|NCT00612872|"     To assess the dynamic uptake and washout of 123-I CLINDE, a potential imaging biomarker for     inflammatory changes in brain, using single photon emission computed tomography (SPECT) in     similarly aged healthy controls and subjects with Alzheimer (AD) or Parkinson disease (PD).      To perform blood metabolite characterization of 123-I CLINDE in healthy and subjects with AD     or PD to determine the nature of metabolites in assessment of 123-I CLINDE as a single photon     computed tomography (SPECT) brain imaging agent.      Evaluate the test/retest reproducibility of 123-I CLINDE, and SPECT in AD and PD subjects and     healthy controls   "
210869|NCT00612885|"     The main objective of this PMS study was to monitor and assess the safety of Mobic®     intramuscular injection (7.5mg ~ 15mg, q.d.) up to 3 days (in case of need for prolonged     treatment, switch to Mobic® capsule therapy was possible) in Korean patients with     osteoarthritis and rheumatoid arthritis.   "
210870|NCT00612898|"     Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often     included as part of patients' treatment, but many HIV-infected patients develop resistance to     commonly used NRTIs such as lamivudine (3TC) and emtricitabine (FTC). This study will examine     whether including apricitabine as part of patients' treatment is more effective than     including lamivudine,when patients change treatment because of drug resistance.   "
210871|NCT00612911|"     Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy   "
211112|NCT00618176|"     The purpose of this study is to determine whether the three generic nevirapine-based     antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome     .   "
210872|NCT00612924|"     The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase     II. The primary objectives of the Phase II study is to assess the safety and effectiveness of     the Anaconda Stent Graft System in subjects presenting with abdominal aortic aneurysm (AAA).     The secondary objectives of this study are to assess additional clinical outcomes     measurements associated with treatment of AAA using the Anaconda Stent Graft System   "
210873|NCT00612937|"     This study will evaluate whether babies are more at risk of developing breathing problems if     their mothers carry group B streptococci (GBS) in vagina/rectum, and whether the breathing     problem is due to phospholipids released by the GBS. About one in five pregnant women carry     GBS in their vagina/rectum. Mothers who carry these bacteria are given antibiotics during     labor to prevent infection in the baby. However, recently it has been suspected that even     without blood stream infection, the chemicals released by GBS, called phospholipids, might     lead to breathing problems.      Women at 32 or more weeks of pregnancy who deliver at Ben Taub Hospital and St. Luke s     Episcopal Hospital in Houston, Texas, and Alta Bates Summit Medical Center in Oakland,     California, may be eligible for this study.      Mothers undergo the following procedures:        -  Vaginal/rectal GBS culture. A sample is collected from the lower vagina and rectum using          a cotton swab upon admission to labor and delivery.        -  Blood collection to test for phospholipids. A blood sample is obtained from the mothers          at the time of routine blood drawing during labor, and a blood sample is obtained from          the umbilical cord (after delivery).        -  Collection of health information from the medical record.      Newborns undergo the following procedures:        -  GBS culture. Samples are collected from cotton swabs of the ears, navel, anus and throat          to test for GBS bacteria.        -  A small amount of blood from newborns is obtained for phospholipids test when the          newborns have blood drawn for other tests.        -  Collection of health information from the medical record.   "
210874|NCT00612950|"     The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to     impaired potentiation of beta-cell responsiveness to glucose by glucose dependent     insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present     study was to investigate whether 4 weeks of near-normalization of blood glucose could improve     the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.   "
210875|NCT00612963|"     The purpose of the study is to evaluate the efficacy of Iocide oral rinse as a treatment for     Oral Candidiasis in any patient including but not limited to patients receiving radiation     therapy or who have previously received radiation therapy for head and neck cancer, or     patients positive for HIV/AIDS or are transplant patients.   "
210876|NCT00612976|"     Under daily routine conditions and without any intervention by the sponsor regarding the     selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non-     medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians     (i.e.general practitioners and internists) are asked to document relevant data related to the     budesonide/formoterole therapy in patients with COPD.   "
210877|NCT00612989|"     Primary objectives To determine maxi tolerated dose of Temodar® in combo w O6-benzylguanine     administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize     toxicity associated w Temodar® in combo w O6-BG administered for 5 consecutive days in pts w     progressive/recurrent GBM To determine Neulasta®-supported MTD defined as the MTD of Temodar®     in combo with O6-BG administered for 5 days while receiving Neulasta® once per treatment     cycle between days 7 & 14 in pts w progressive/recurrent GBM To obtain preliminary response     rates of Temodar® in combo w O6-BG administered for 5 consecutive days in pts w     progressive/recurrent GBM   "
210878|NCT00613002|"     This study is a randomized, double-blind, placebo-controlled, multi-center study of the     safety and efficacy of LibiGel® 300mcg in the treatment of HSDD in surgically menopausal     women   "
210879|NCT00613015|"     Stressful situations and cues associated with cocaine can lead to craving in cocaine     dependent individuals. The purpose of this study is to determine whether guanfacine or     modafinil are effective in reducing stress and cue induced craving in cocaine dependent     individuals.   "
210880|NCT00613028|"     Primary objective To estimate 6-month progression free survival probability of pts w     recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on     bev + irinotecan Secondary Objectives To evaluate safety & tolerability of bev + either daily     temozolomide/etoposide among pts w recurrent GBM who have progressed on bev + irinotecan To     evaluate radiographic response, progression free survival & overall survival of pts w     recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on     bev + irinotecan   "
210881|NCT00613041|"     In recent years, more and more people are having lung CT scans performed to screen for     various cancers. Many of them have small abnormalities detected, called nodules, which -     for a variety of reasons - doctors are unable to biopsy. As a result, many patients have     their CT scans repeated on a regular basis to see if their nodules grow. This process can     last several years.      Many patients experience significant anxiety during this process, when they are aware of a     spot in the lung, but are not told any specific cause.      Researchers at Memorial Sloan-Kettering have developed a new way to look at lung nodules in     three dimensions. The purpose of this project is to see if any change in the nodules can be     detected sooner by this method than by traditional CT scans.   "
210882|NCT00613054|"     Primary Objective To determine maximum tolerated dose & dose limiting toxicity of Zactima     when combined w standard dosing of imatinib mesylate & hydroxyurea among pts w recurrent     malignant glioma who are on & not on enzyme-inducing anti-epileptic drugs Secondary     Objectives To assess safety & tolerability of Zactima + imatinib mesylate & hydroxyurea To     evaluate pharmacokinetics of Zactima among MG pts on & not on enzyme inducing anti-epileptic     drugs (EIAEDs) when combo w imatinib mesylate & hydroxyurea To evaluate pharmacokinetics of     imatinib mesylate among MG pts on & not on EIAEDs when combo w Zactima & hydroxyurea     Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among     recurrent malignant glioma (RMG) pts including radiographic response rate, 6-month     progression free survival (PFS) rate & median PFS   "
210909|NCT00613418|"     This is a prospective, multicenter, non-randomized, single-arm trial; the primary objective     is to assess the comparability of the performance of the IDev SUPERA® nitinol stent to a rate     derived from a meta-analysis of studies on iliac stents approved by FDA for treating subjects     with de novo or restenotic lesions in the common and/or external iliac arteries.   "
210883|NCT00613067|"     Amplitude changes of the N1 and the N1/P2 ERP component in response to different tone     intensities have been suggested as a correlative of central serotonergic activity. A strong     loudness dependence amplitude increase (strong intensity dependence) reflects low     serotonergic neurotransmission and vice versa. Many researchers assumed that the brain     serotonergic activity could influence treatment response of highly selective serotonin     reuptake inhibitors in depression and anxiety disorders. There are a couple of studies     reporting associations of N1 amplitude intensity dependence with response to Citalopram     (positive correlation) and Reboxetine (negative correlation) treatment in major depressive     disorder patients. But so far there have been no reports about associations between ERP N1     and antidepressant response in GAD patients.      So, it would be very interesting to explore the correlations between ERP N1 amplitude change     and the Escitalopram treatment responsiveness in GAD patients.   "
210884|NCT00613080|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Specialized radiation     therapy that delivers a high dose of radiation directly to the tumor may kill more tumor     cells and cause less damage to normal tissue. Giving these treatments before surgery may make     the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving     chemotherapy after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying the side effects and how well giving combination     chemotherapy together with intensity-modulated radiation therapy works in treating patients     undergoing surgery for locally advanced rectal cancer.   "
210885|NCT00613093|"     Objectives:      To define role of O6-Benzylguanine (BG) in restoring Temodar (temozolomide) sensitivity in     patients with Temodar-resistant malignant glioma.      To further define toxicity of combo therapy using Temodar + BG.   "
210886|NCT00613106|"     The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.   "
210896|NCT00613249|"     IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one     research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age,     randomized in a 1:1:1 ratio to assess plasma, vaginal fluid and vaginal tissue levels and the     pharmacokinetics of dapivirine when applying either Dapivirine Gel 4750, 0.05%, 2.5g or     Dapivirine Gel 4789, 0.05%, 2.5g intravaginally for 11 days (1 day followed by a 3 day     washout period and then 10 consecutive days); and to assess the safety of these gels as     compared to the intravaginal HEC-based universal placebo gel.   "
210887|NCT00613119|"     This study will use positron emission tomography (PET) imaging to measure a receptor in the     brain that is involved in inflammation. Certain neurological disorders, possibly including     frontotemporal dementia (FTD), are associated with increased inflammation in the brain. This     study may help elucidate the relationship between FTD and inflammation.      Patients with FTD and healthy volunteers who are 35 years of age or older may be eligible for     this study. Candidates are screened with a medical history, physical examination,     electrocardiogram, and blood and urine tests.      Participants undergo the following procedures:        -  Whole body PET scan: PET uses small amounts of a radioactive chemical called a tracer          that labels active areas of the brain so the activity can be seen with a special camera.          The tracer used in this study is [11C]PBR28. Before starting the scan, a catheter          (plastic tube) is placed in a vein in the arm to inject the tracer. Pictures are taken          for 1 hour. This short scan is done to determine if [11C]PBR28 binds to the subject s          receptors, since a number of people do not have binding. Subjects who have binding          continue with brain PET and MRI scans, described below.        -  Brain PET imaging: Before starting the scan, a catheter is placed in a vein in the arm          to inject the tracer,<TAB> and another catheter is placed in an artery in the wrist to          obtain blood samples during the scan. The subject lies on the scanner bed. A special          mask is fitted to the head and attached to the bed to help keep the person s head still          during the scan so the images will be clear. An 8-minute transmission scan is done just          before the tracer is injected to provide measures of the brain that are helpful in          calculating information from subsequent scans. After the tracer is injected, pictures          are taken for about 2.5 hours, while the subject lies still on the scanner bed.        -  Blood and urine tests are done the day of and the day following each PET scan.        -  Magnetic resonance imaging (MRI): An MRI scan is done within 1 year (before or after) of          the PET scan. This procedure uses a magnetic field and radio waves to produce images of          the brain. The subject lies on a table that is moved into the scanner (a tube-like          device), wearing earplugs to muffle the noise of the machine during the scanning          process. The test takes about 1 hour.   "
210888|NCT00613132|"     Primary objective To determine maximum tolerated dose & dose limiting toxicity of imatinib     mesylate & RAD001 when combined w fixed doses of hydroxyurea among pts w recurrent GBM who     are on & not on enzyme-inducing anti-convulsants including pts not on anti-epileptic drugs     Secondary objective To assess safety & tolerability of imatinib mesylate in combo w RAD001 &     hydroxyurea in this population To characterize single-dose & repeated-dose pharmacokinetic     profiles of imatinib mesylate & RAD001 combo therapy in this pt population.      To assess antiangiogenic effects, pre- and post-treatment, of imatinib mesylate, RAD001 &     hydroxyurea combo therapy, using DCE-MRI to evaluate changes in extent of vascular     permeability, perfusion & relative tumor blood volume; to explore assessment of tumor     cellularity & tumor cell death by changes in DWI-MRI as quantitated by apparent diffusion     coefficient maps.   "
210889|NCT00613145|"     This is a phase I, randomized, safety and pharmacokinetic (PK) study of sorafenib given in     combination with capecitabine. The study will enroll two simultaneous cohorts; patients will     be randomly assigned to either Cohort A or Cohort B. A third cohort (C) may be added to the     protocol at a later date.   "
210890|NCT00613158|"     Cardiovascular disease (CVD), including heart disease, heart attack, high blood pressure, and     stroke, is most commonly caused by atherosclerosis, or a hardening of the arteries.     Traditional risk factors for CVD include age, high blood pressure, high cholesterol,     diabetes, and smoking. Although these established risk factors can be helpful in determining     people at risk for developing CVD, the addition of novel gene markers for subclinical, or     suspected, atherosclerosis (SA) may enhance CVD risk prediction and understanding of disease     mechanisms. This study will compare specific genes of white blood cells in people with     significant SA versus people without SA to improve identification of those at risk for     developing CVD and to better understand the biological basis of SA.   "
210891|NCT00613171|"     This study will investigate the efficacy and safety of STI571 for the treatment of fibrosis     in patients with systemic sclerosis. Other purposes of the study are to investigate whether     STI571 is effective in improving lung functions and other test results called biomarkers.     Whether STI571 is well-absorbed in systemic sclerosis patients' gut will also be investigated     by testing the drug level in the blood (pharmacokinetics).   "
210892|NCT00613184|"     Collection of nasal secretions from infants and toddlers for viral testing is usually done     using the nasal washing technique described by Hall in 1975. This is cumbersome. Previous     attempts to use swabs have been unsuccessful because the swabs didn't work well. A newly     designed swab may work better and in this study we compare the new swab with the old style     nasal washing.   "
210904|NCT00613353|"     Objective activity data will be collected using accelerometry for a minimum of seven days on     38 adult, female, women recruited from the metabolic Clinic at the University of Mississippi     Medical Center. Following objective measurement of activity, participants will complete     self-report and objective activity data, as well as the relationship between sedentary     activities and food cravings will be examined. It is hypothesized that minutes of sedentary     behavior, especially time spent in television viewing, will be significantly correlated with     total and specific food cravings.   "
210893|NCT00613197|"     The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin     Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease     Activity Index CDAI < 150) in CD patients in whom remission, stable for at least three months     and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP,     methotrexate, 5-ASA or antibiotics.      Secondary objectives are to assess the:      efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and     Subject Global Ratings, employment status and use of CD related medical visits in subjects     with CD in remission      safety and tolerability of Epanova      ability of Epanova to maintain the quality of life of CD patients in remission   "
210894|NCT00613210|"     to evaluate if sonographic measure of short uterin cervix, sludge in amniotic fluid and     abnormal doppler of the uterin artery can predict preterm labor   "
210895|NCT00613223|"     Primary Objective: To determine maximum tolerated dose & dose limiting toxicity of vandetanib     when combined with standard dosing of etoposide among patients with recurrent malignant     glioma who are on & not on enzyme-inducing anti-epileptic drugs (EIAEDs) Secondary     Objectives: To assess safety & tolerability of vandetanib + etoposide in this population; To     evaluate pharmacokinetics of vandetanib among malignant glioma patients on & not on EIAEDs     when combined with etoposide.      Exploratory Objective: To evaluate for evidence of anti-tumor activity of study regimen among     recurrent malignant glioma patients including radiographic response rate, 6-month progression     free survival (PFS) rate & median PFS.   "
210897|NCT00613262|"     The investigators hypothesize that NBI will have a high accuracy in predicting polyp     histology real time during a colonoscopy by visualization of the surface mucosal and vascular     patterns. Aim#1: To determine the sensitivity, specificity and accuracy of NBI and standard     white light colonoscopy for predicting polyp histology by evaluating the surface mucosal and     vascular patterns during colonoscopy. Aim#2: To determine the inter-observer agreement     between investigators for the recognition of various polyp patterns.   "
210898|NCT00613275|"     The Boston University Medical Center, funded by the National Cancer Institutes will train     health workers at six of its affiliated Community Health Centers to guide patients through     the cancer care system. The project will help to teach patients how to communicate more     effectively with their health care team in order to understand the treatment options     available to them. Although not widely available, it is believed patient navigation programs     are beneficial.      This research study will evaluate how well this tool works, especially among those who     experience disparities in health care. The goal is to determine if having a trained navigator     shortens the time between an abnormal test result and a definitive diagnosis and between a     definitive diagnosis and completion of treatment for breast and Cervical cancer patients. The     project also will evaluate whether navigation improves the ability to communicate with the     doctor, satisfaction with patient's care and quality of life.   "
210899|NCT00613288|"     Testosterone(T) has known effects on many organ systems, although many of its metabolic     actions are unrevealed. T is an anabolic hormone stimulating protein synthesis but this     effect has barely been investigated in controlled studies. It also has lipolytic actions     influencing body composition, but little is known of its regional impact on fat tissue. T     affects insulin sensitivity. There is an increased incidence of hypogonadism in type 2     diabetes, and among patients with hypogonadism there is an increased incidence of type 2     diabetes. The actions of testosterone on glucose metabolism are unknown.      The purpose of this study is therefore to:      Investigate the lipolytic effect of testosterone on muscle and fat tissue. To gain insight in     the intracellular mechanisms of testosterone on lipolysis and investigate possible regional     differences in lipolysis and changes in body composition.      Finally to investigate the effect of short term experimental hypogonadism and acute     testosterone substitution on cytokines, insulin sensitivity and protein metabolism.      The trial is a randomised double blinded cross-over study of 4 x 2 days with an interval of 1     month in between. 12 healthy young men will receive GnRH treatment over a 3 month period and     examined on 4 occasions with various degrees of T substitution and placebo . The examinations     take place at the Research Lab within the Medical Department M.      The investigations are deemed relevant to the understanding of the interrelationship between     male hypogonadism and type 2 diabetes. The hypothesis is that T has beneficial effects on     carbohydrate, fat and protein metabolism. The generated knowledge would therefore hopefully     improve prophylaxis, screening and early treatment of both group of patients.   "
210900|NCT00613301|"     The survey is conducted to collect safety and effectiveness information in Parkinson's     Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the     daily clinical settings in Japan.   "
210901|NCT00613314|"     To determine the efficacy and safety of telmisartan-based treatment among patients with     metabolic syndrome in actual setting in Philippines.   "
210902|NCT00613327|"     The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic     therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose     escalation in participants with overactive bladder.   "
210903|NCT00613340|"     Cervical facet arthropathy is a common cause of chronic neck pain. The gold standard for     diagnosis is either blocking the facet joints, or more commonly blocking the medial branch     nerves that innervate the joints. However, many studies have found a high false-positive rate     when the nerves are blocked using 0.5 ml of local anesthetic. We will randomize patients to     receive either cervical facet medial branch blocks with 0.25 ml of local anesthetic and     contrast, or 0.5 ml. We will then do a CT scan to determine the accuracy and specificity of     each block. Our hypothesis is that using the higher volume (0.5 ml) might be responsible for     the high false-positive rate.   "
210905|NCT00613366|"     The purpose of this study is to see if using misoprostol (a medication that softens the     cervix) before placing an intrauterine device for contraception reduces pain in women who     have never delivered a baby.   "
210911|NCT00613444|"     The purpose of this research project is to study the effect of non-ablative (non-cutting)     laser therapy, a technique that uses laser energy to try to improve the appearance of the     skin. This type of laser treatment creates changes in a layer of the skin called the dermis     without causing an open wound in the skin. The use of non-ablative laser therapy, together     with application of a photo-sensitizer (substance that makes the skin more sensitive to     light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it     is supposed to make the laser more effective than using just the laser alone. It is not yet     clear how much improvement can be seen with these treatments or exactly how the skin's     response causes these improvements. In this study, we are interested in learning how well     such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer     actually enhances the efficacy of the laser.      The photo-sensitizing agent (Levulan Kerastick) and the non-ablative laser (LumaCare LC-122M     non-coherent (multiple wavelengths) light source from LumaCare® Medical Products) are both     FDA-approved. The Levulan Kerastick is approved for the treatment of another skin disease,     not acne.   "
210912|NCT00613457|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which     combination chemotherapy regimen is more effective in treating young patients with acute     lymphoblastic leukemia.      PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens     to compare how well they work in treating young patients with acute lymphoblastic leukemia.   "
210924|NCT00613626|"     At this point in the treatment of extensive stage SCLC, we have reached a plateau in survival     with conventional chemotherapy and newer regimens are greatly needed. It has been noted that     patients with increased VEGF levels have a poorer prognosis. Anti-angiogenic agents hold     significant promise in the treatment of patients with extensive stage SCLC. ZD6474, a new     inhibitor of the VEGFR-2, has shown favorable action in NSCLC.   "
210925|NCT00613652|"     The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a     weekly schedule in Japanese patients with advanced solid malignancies   "
210926|NCT00613665|"     This study was designed to investigate the safety and immunogenicity of Chiron's     investigational H. pylori (HP3) vaccine   "
211239|NCT00609102|"     This study examines whether an antioxidant taken orally will improve glucose tolerance and     insulin secretion in type 2 diabetic subjects.   "
210913|NCT00613470|"     This study is one component of a larger U01 grant that was submitted in August, 2004 to the     NIGMS as part of the Pharmacogenomic Research Network. This study will enroll 1200 patients     over 4 years.      It is known that functionally significant genetic polymorphisms for the cytochrome P450     (CYPs) can contribute to individual differences in response to specific selective serotonin     reuptake inhibitors (SSRIs). However, a better understanding of the pharmacogenomics of both     PK and PD for SSRI antidepressants will inform clinical practice. Therefore, we propose to     evaluate the contribution of pharmacogenomics to variation in response to the highly specific     SSRIs citalopram (a racemic mixture) and escitalopram (a chiral compound containing the     active S-isomer of citalopram ) by correlating both PK and PD variation for these agents with     intragene haplotypes in genes encoding proteins involved in citalopram metabolism, as well as     central nervous system (CNS) pathways for monoamine neurotransmitter biosynthesis,     metabolism, storage, release, reuptake, and receptors. In the future this candidate pathway     intragene haplotype genotyping strategy will also be complemented by the application of     genome-wide screens performed with DNA from subjects with extreme phenotypes for response to     citalopram.      Phenotypes to be measured before and after the initiation of citalopram or escitalopram     therapy will include determinations of serum citalopram and metabolite concentrations,     treatment response as measured by Hamilton Rating Scale for Depression indices, and number     and severity of side effects as determined by structured questionnaires. The hypothesis to be     tested is that inherited variation in citalopram metabolism and transport (PK) and/or PD     variation as a result of inherited variation in monoamine neurotransmitter biosynthesis,     metabolism, reuptake, storage, receptors or signaling contribute to individual variation in     citalopram antidepressant efficacy and/or side effects.   "
210914|NCT00613496|"     Experimental data suggest that angiotensin II-antagonists reduce the atrial expression of     prothrombotic adhesion molecules and oxidative stress parameters. The present study is     designed to investigate the effects on angiotensin II-antagonist irbesartan to reduce the     amounts of circulating oxidative stress markers and adhesion molecules in patients with     persistent atrial fibrillation.   "
210915|NCT00613509|"     Primary objective:      To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free     survival versus the clinical activity of the reference treatment.      Secondary objectives:      Safety: To describe the safety profile in both treatment groups.      Efficacy: To determine the objective clinical responses of patients in both treatment groups:     complete response and partial response.   "
210916|NCT00613522|"     Stroke is the third leading cause of death in industrialized countries and the first cause of     handicap in adults. Several stroke risk factors were identified such as high blood pressure,     diabetes mellitus, hypercholesterolemia or cardiac arrhythmias. Sleep respiratory disorders     have been found to be frequent among patients with stroke. Among them obstructive sleep apnea     (OSA) syndrome seems to be the most important due to its association with high blood pressure     and atrial fibrillation.      Stroke can be responsible of central apneas, therefore the differential diagnosis between     central apneas and pure OSA after stroke is sometimes difficult. The misidentification of OSA     can explain the poor tolerance of CPAP treatment by these patients. The purpose of the     present study is to investigate the association between pre-stroke OSA syndrome OSA diagnosed     on specific scales and confirmed by polygraphic studies and stroke occurrence.   "
210917|NCT00613535|"     The aim of this study is to describe changes at the site of the study patient's articular     cartilage lesion on the femoral condyle with multiple magnetic resonance imaging (MRI)     outcomes 6 months after treatment using one of three standard surgical treatment methods: 1)     lavage debridement; 2) mechanical debridement; 3) mechanical and radiofrequency-based     debridement.   "
210918|NCT00613548|"     Background:      The presence of a mild to moderate ischemic mitral regurgitation (IMR) results in a     significantly reduced long-term survival and increased hospitalizations for heart-failure.     The benefit of adding mitral valve surgery to coronary artery by-pass surgery (CABG) is well     documented in the combination of coronary artery disease and severe MR. On the other hand, it     is clinical practice to refrain from repairing the mitral valve in those CABG cases where the     IMR is mild to moderate. However, there are no conclusive data available to support this     principle. The existing studies are small, retrospective, and the results contradictive. The     need for a prospective randomized trial has frequently been proposed and discussed, however,     to the best of our knowledge, such a study has not yet commenced.      Study design:      The Moderate Mitral Regurgitation In Patients Undergoing CABG (MoMIC) Trial is the first     international multi-center, large-scale study to clarify whether moderate IMR in CABG     patients should be corrected. A total of 550 CABG patients with moderate IMR are to be     randomized to either CABG alone or CABG plus mitral valve correction.      Implication:      If correction of moderate MR in CABG patients is the superior strategy, this should be     offered to all patients in this entity.   "
210919|NCT00613561|"     The hypothesis of this study is that children with severe primary immunodeficiencies will     benefit from early stem cell transplantation utilizing a reduced intensity conditioning     regimen. This regimen is associated with a low risk of complications and will lead to     correction of the underlying immunological defects.   "
211144|NCT00618618|"     Phase 2 trial to evaluate the safety and potential efficacy of one concentration of     deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the     reduction of submental fat (fat beneath the chin).   "
210920|NCT00613574|"     At the moment, there is hardly any structured safety and efficacy data collection on     Tiotropium in Russia. Therefore, the objective of this observational study is to collect and     evaluate data on bronchodilator efficacy and safety of Spiriva® (18 µg tiotropium inhalation     capsules) delivered by HandiHaler®, in a national sample of Russian patients with varying     severities of chronic obstructive pulmonary disease (COPD) in a real life setting over the 8     weeks.   "
210921|NCT00613587|"     This study is looking for allergic asthmatics. Lung and allergy testing will be done to     verify. If qualified, blood will be drawn for laboratory studies.   "
210922|NCT00613600|"     Overweight and obesity are serious and growing problems within the United States. The usual     approaches to weight loss-dieting, exercise, and behavioral interventions-rarely result in     long-term weight loss. Therefore, we will evaluate the safety and efficacy of glucomannan, a     fiber supplement that has promising weight loss effects.   "
210923|NCT00613613|"     The purpose of the study is to learn whether genetics plays a role in predicting response to     a commonly used and FDA (Food and Drug Administration) approved medication for lowering     triglycerides and cholesterol. Our hypothesis: The pharmacogenetics of genes which affect     drug metabolism (how the body handles the drug) and drug targets (how the drug acts on the     body) influences how a person responds to the lipid lowering medication- fenofibrate.   "
210937|NCT00604123|"     The purpose of this study is to evaluate the clinical effectiveness, safety and     pharmacokinetics of JNJ-17166864 in patients with seasonal allergic rhinitis.   "
210927|NCT00613678|"     Purpose: To study the effects of two different rehabilitation programs for people with     osteoarthritis of the hip or knee.      Hypothesis 1: Participants who received Activity Stratgey Training will report less pain and     physical disability at 8-weeks and 6-months follow-up.      Hypothesis 2: Participants who receive Activity Strategy Training will have a greater     increase in physical activity as measured by a wrist-worn accelerometer.      Hypothesis 3: Participants who receive Activity Stratgey Training will report greater     improvements in health-related quality of life.   "
210928|NCT00613691|"     This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the     Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD     properties. Once the MTD for SPI-1620 is identified, a second phase of the study will focus     on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study     will assess the safety and tolerability of increasing doses of docetaxel administered with     the optimal dose of SPI 1620 defined in Part I.   "
210929|NCT00613717|"     The Healthy Infant Development Project will determine if providing micronutrient supplements     to mothers during pregnancy and infants in the first 9 months fosters healthy behavior and     development in babies.   "
210930|NCT00613730|"     This is a phase II, multi-center, open-label, single-arm clinical trial to be conducted in     the United States. In approximately 55 centers, approximately 75 eligible locally advanced     unresectable or metastatic pancreatic cancer subjects will be enrolled to receive first-line     therapy of gemcitabine and panitumumab.   "
210931|NCT00613743|"     Introduction:      Oral pain due to mucosal lesion is quite frequent in oncology, geriatric as well as     palliative care settings. The oncology patient is mainly suffering from radio- and/or     chemotherapy induced oral mucositis. The incidence of oral mucositis in oncology patients     ranges from 15-40% in those receiving stomatotoxic chemotherapy or radiotherapy. The degree     of mucositis is variable, but the associated pain is frequent and well documented. Nowadays,     basic oral care protocols are the mainstay of preventing or reducing mucositis pain. Pain is     mainly managed by systemically administered analgesia. The only pioneer work in the field of     radio-or chemotherapy induced mucositis treatment with topical opioids has been done by     Cerchietti in two pilot studies: one compared magic mouthwash (lidocaine, diphenhydramine,     magnesium aluminium hydroxide) with morphine mouthwash in a randomized trial; the other     compared 1%o and 2% morphine solutions in an open trial. The results showed a significant     decrease in the duration of pain, the intensity as well as a decrease the need for systemic     analgesia in the group with morphine mouthwash. No systemic clinically relevant adverse     effects were noted.      Hypothesis:      Mouthwashes with a morphine containing solution decrease oral pain substantially, while not     causing the side effects seen in systemic administration of narcotic analgesics.      Method:      A randomised double-blind cross-over study to evaluate the effect of topical oral application     of a 0.2% morphine solution in patients suffering from radio- and/or chemotherapy induced     oral mucositis. 60 patients will be included. Randomly assigned to either the morphine     solution or a placebo mouthwash, they receive the first three days one of the solutions and     then are switched over to the other treatment for three more days. General basic oral care is     offered to all of the patients. Efficacy of treatment will be measured with a self-assessment     pain scale. Doses of systemic opioids and other symptoms (appetite, dysphagia) will also be     measured. If patient's don't receive systemic opioids, serum concentrations of morphine will     be measured.   "
210932|NCT00613756|"     The survey is conducted to collect safety and effectiveness information targeting patients     who have both Parkinson's disease and renal dysfunction treated with Pramipexole in the daily     clinical settings in Japan.   "
210933|NCT00613769|"     The current standard Swedish infection prophylaxis in colorectal surgery is intravenously     administered cefuroxime and metronidazole. this combination is well studied. The     disadvantages of the regimen is collateral damage resulting from treatment with a     cephalosporine and that the combination also serves as the first line of treatment for     abdominal surgical infections.      Serval Swedish surgical departments have for some years used a combination of orally     administered trimethoprim-sulfamethoxazole and metronidazole.      The combination is economical and believed to be effective but hitherto the outcome have not     been properly researched.      The aim of this study is to compare the efficacy of these two regimens in the prevention of     infection after elective colorectal surgery.   "
210964|NCT00613964|"     Carperitide (alpha-human atrial natriuretic peptide) improves systemic hemodynamics in     patients with heart failure through a vasodilatory action, a natriuretic action, and     inhibition of the renin-angiotensin-aldosterone system and has been widely-used in Japan.     However, a paucity of report is available on the effects of carperitide on short and     long-term prognosis in patients with both cardiac and renal failure. The purpose of this     study is to evaluate the effects of carperitide therapy on short and long-term prognosis in     patients with both cardiac and renal failure, in comparison with standard therapy.   "
210934|NCT00613782|"     In men with type 2 diabetes, low testosterone levels have been associated with insulin     resistance, truncal obesity and symptoms such as fatigue and erectile dysfunction. Low     testosterone may impair cardiac function and increase cardiovascular risk and cause     osteoporosis. The goal of this project is to assess prospectively whether, in men with type 2     diabetes mellitus and low testosterone levels, testosterone replacement improves insulin     resistance, body composition, bone density, cardiac function symptoms associated with low     testosterone level.      The investigators will recruit 140 ambulatory men with type 2 diabetes and a low serum     testosterone level (<10 nmol/L) from Austin Health Endocrine clinics, General Practise     surgeries, and from the general public by direct consumer advertising via newspaper and other     local media. Men will be randomised to either intramuscular testosterone undecanoate     (Reandron 1000, Bayer Schering Pharma) or placebo. Men with contraindications to testosterone     replacement or to intramuscular injections will be excluded from the study. All men will     receive intramuscular testosterone or placebo injections at 0, 6, 18 and 30 weeks (a total of     four injections).      All 140 study subjects will have a clinical and laboratory assessment at baseline, 18 weeks     and at study end (40 weeks). All 140 subjects will also have imaging studies at baseline and     at study end (40 weeks). The study protocol is outlined in more detail below:      Clinical and laboratory assessment (Baseline and repeated 18 weeks, 40 weeks) A full medical     history and physical examination will be performed. Symptoms will be assessed by the     following standardised questionnaires: 1) Androgen Deficiency in the Aging Male (ADAM); 2)     Aging Male Symptom scale (AMS); 3) International Index of Erectile Dysfunction (IIED); 4)     International Prostate Symptom Score (IPSS); 5) SF-36 (all five questionnaires are attached     to Module 1).      Laboratory studies will consist of blood tests to measure total testosterone, fasting     glucose, C-peptide, HBA1c and other routine parameters.      Imaging studies (Baseline and repeated at 40 weeks)        1. Body composition and bone mineral density by DEXA        2. Body composition by magnetic resonance imaging        3. Bony micro-architecture by high resolution quantitative computed tomography [HR-pQCT]),        4. Cardiac dimensions and function by transthoracic doppler echocardiography   "
210935|NCT00613795|"     This study utilizes lactobacillus, or probiotics, delivered twice daily to the mouth and     stomach, via feeding tube, in effort to determine whether the oral administration of a     naturally occurring Lactobacillus species reduces the incidence of ventilator associated     pneumonia therefore reducing intensive care unit(ICU)complications.   "
210936|NCT00604110|"     Patients with reduced left ventricular function are at an increased perioperative risk and     often need prolonged postoperative treatment on intensive care units. A significant portion     of these patients require postoperative pacing. Right ventricular pacing has been shown to be     hemodynamically deleterious The aim of this study is to determine which biventricular pacing     after cardiac surgery, in patients with reduced left ventricular function (EF≤ 45%), is     hemodynamically favourable.   "
210938|NCT00604136|"     Prior preclinical and clinical studies have shown that tumors from patients with advanced     melanoma contain tumor-infiltrating lymphocytes (TIL) with anti-tumor reactivity. These TIL     can be expanded in the laboratory to large numbers, and reinfused to the patient. Using a     chemotherapy regimen that selectively kills lymphocytes, a single institution Phase II study     of 35 patients showed a 51% objective response rate to TIL and interleukin-2 injection. In     the present trial we would like to investigate whether we can achieve similar results in a     Hadassah Phase II study, and to determine the feasibility of applying this approach to     patients with advanced melanoma who currently have few treatment options.   "
210939|NCT00604149|"     Sudden death is a major problem in industrially developed countries. Despite a decline in     ischemic heart disease mortality and the progress has been made in resuscitation, treatment     of sudden death victims is frequently unsuccessful. the ideal solution would be to prevent     the disease process that causes the initial episode of cardiac arrest. Parental sudden death     is an independent risk factor for sudden death. So, detect a gene predisposing to sudden     death may help provide better identification of subjects at high risk of cardiac arrest. This     research is a genetic study of sudden cardiac death, recruited 2000 subjects in     out-of-hospital cardiac arrest.   "
210940|NCT00604162|"     To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant     colonic pathologies when compared to colonoscopy in the target population.   "
210941|NCT00604175|"     Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV     infection can cause genital warts and certain cervical problems, including cervical cancer.     HPV infection may be more severe and harder to treat in HIV-infected people. The purpose of     this study was to determine whether the quadrivalent HPV vaccine is safe, tolerable, and     effective in producing antibodies to HPV in HIV-infected women.   "
210942|NCT00604188|"     The purpose of this study is to assess the acceptability and safety of Suboxone in heroin     users as a replacement therapy for opioid dependency by comparing the clinical response of     participants who are inducted directly onto Suboxone with that of participants who are     inducted first to Subutex and then transferred to Suboxone.   "
210943|NCT00604201|"     This study will evaluate the safety and effectiveness of treating patients with severe     aplastic anemia (SAA) or myelopdysplastic syndrome (MDS) with both peripheral blood stem     cells from a family member and umbilical cord blood stem cells from an unrelated donor.      Patients with SAA or MDS for whom other treatments have failed or are not available may be     eligible for this study. Candidates may not have a tissue-matched sibling or matched     unrelated donor and must have a family member who is a partial tissue type match.      Participants undergo the following tests and procedures:        -  Insertion of a central intravenous (IV) line (plastic tube) into a large vein. The tube          is used for giving the donated stem cells and antibiotics and other medicines, for          transfusions of red blood cells and platelets, and for collecting blood samples.        -  Preparatory chemotherapy (fludarabine, cyclophosphamide and anti-thymocyte globulin) and          total body irradiation to suppress immunity and prevent rejection of the donated cells.        -  Infusion of the donated stem cells and umbilical cord cells.        -  Immune suppression with the drugs tacrolimus, mycophenolate mofetil and prednisone to          prevent rejection of the donated cells and to prevent graft-versus-host disease (GVHD),          a complication of stem cell transplants in which the donor s immune cells destroy the          patient s healthy tissues.      The average hospital stay after stem cell transplantation is 3 to 4 weeks. Patients return     for frequent follow-up visits for the first 2 to 4 months after transplantation. Once the     patient returns home, his or her referring physician is asked to send results of any     laboratory testing to the NIH researchers at least every 3 months for the first 3 years and     annually thereafter. Patient follow-up visits are scheduled at NIH at 1, 2, 3, 4 and 5 years     after transplantation to monitor for signs of disease or post-transplantation complications,     such as infection or GVHD. After 5 years, participants are offered the opportunity to enroll     in NHLBI s long-term evaluation and follow-up care protocol.   "
210944|NCT00604214|"     The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated)     treatment provides significant mortality reduction improvement in patients with septic shock     compared with placebo treatment in patients receiving the current standard of care for septic     shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in     reducing 28-day mortality in patients with septic shock and concomitant severe protein C     deficiency.   "
211024|NCT00616993|"     The purpose of this phase III study is to determine the safety and efficacy of difluprednate     in the treatment of inflammation following ocular surgery.   "
210945|NCT00604227|"     Based on the findings of decreased vital capacity, decreased FEV1 and increased closing     volume after ascent to high altitude, some investigators suggest the presence of a     subclinical high altitude pulmonary edema (HAPE). Since these parameters are only indirect     measures of pulmonary interstitial fluid accumulation, the aim of this study is to examine     the effects of broncho-constriction on the increase of closing volume by extensive lung     function testing in healthy mountaineers at low altitude and on the Margherita Hut (4559 m).     As has been done in earlier studies, conventional thorax radiographs are used for     verification of HAPE. In this study, the determination of the thoracic fluid quantity will be     completed by measurements of thoracic impedance. In addition markers of pulmonary endothelial     function will be assessed to get further insight into the regulation of pulmonary vascular     tone at altitude and in particular into the pathophysiology of HAPE.   "
210946|NCT00604240|"     The first few weeks after leaving the Neonatal Intensive Care Unit (NICU) can be a difficult     transition time for caregivers of a previously hospitalized infant. To help ease this     stressful period, doctors and nurses give caregivers a large amount of information prior to     their infant leaving the NCIU. How much caregivers remember about medications, follow-up     appointments, and general well-child care has not been studied. Caregivers who choose to     participate will receive a phone call 2-7 days after discharge where they will be asked     questions pertaining to the information that was discussed with them at the time of     discharge. The purpose of the study is to determine how much information caregivers retain     after leaving the NICU.   "
210947|NCT00604253|"     This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of     insulin detemir on blood glucose control in type 2 diabetes when added to current OHA     treatment.   "
210948|NCT00604266|"     To evaluate the feasibility and performance of coregistered 18F-FDG-PET/MRI in the staging of     potentially respectable hilar cholangiocarcinoma.   "
210949|NCT00604279|"     The purpose of this study is to compare the efficacy of paliperidone palmitate and     risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric     disorder with symptoms of emotional instability, detachment from reality, often with     delusions and hallucinations, and withdrawal into the self) along with safety and     tolerability.   "
210950|NCT00604292|"     To evaluate the effect of a modified preparation and procedure on colon cleansing level   "
210955|NCT00613847|"     The purpose of this study is to learn more about how a new study agent works inside the body.     This study agent is a protein called 68Ga-F(ab')2-trastuzumab fragments (HERScan). This is a     radioactive tracer that was developed at MSKCC to target the HER2 protein on cancer cells. By     giving this tracer to patients whose cancers have the HER2 protein, we hope to be able to see     the level of HER2 on the cancer cells using PET scanning.   "
210956|NCT00613860|"     Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until     now the technique is limited to one lobe. In case of collateral ventilation patients show no     improvement. Between upper and middle lobe exists the highest collateral flow. The trial     examine the hypothesis, that sequential ELVR help especially those patients, which have no     benefit after lobar exclusion.   "
210957|NCT00613873|"     Colorectal cancer is a cancer in the colon or rectum. Routine screening can find it at an     early stage, when it has a much higher chance of cure. Screening can also help to find     polyps. These are mushroom shaped growths that could turn into cancer. A polyp can be removed     before it turns into cancer. Even though screening can save lives, not enough people in the     country are having it. This is especially true in Harlem. Harlem has a higher rate of deaths     from this cancer than other places in the U.S. because too many people do not get screened.     By the time a person has symptoms, the cancer may be at a late stage, when it is much harder     to cure.      We are doing this study to see if we can increase the number of people in Harlem who get     screened. We plan to tell women about the screening when they have a mammogram or pap test.     We will also ask them what they know and think about colorectal cancer. And, we will see if     they get other members of their household to be screened.   "
210958|NCT00613886|"     The research project is designed to determine which combination of tests will enable     physicians to predict whether a patient with symptoms of normal pressure hydrocephalus (NPH)     will improve with a shunt.   "
210959|NCT00613899|"     The investigators want to test feasibility of a structured program of telesurveillance and     home cough assistance for ALS patients.   "
210960|NCT00613912|"     Depression is the most common psychiatric disorder.        -  3-5% of a given population has major depression.        -  Less than 50% of the depressed in Denmark are diagnosed with major depression.        -  25-50% of the depressed have a relative with major depression-underlying brain          pathology?      The purpose of this study is to use MRI to evaluate cerebral morphology and function in     ambulant patients with major depression   "
210961|NCT00613925|"     The purpose of this study is to determine the level of pain women experience during an     endometrial biopsy and the effect that the biopsy tool might have on that pain. The     investigators will also evaluate the adequacy of the sample each endometrial biopsy tool     collects.   "
210962|NCT00613938|"     The purpose of this study is to evaluate the effectiveness (level of pain control) and safety     of the administration of 2 different dose levels of tapentadol (CG5503) compared with     oxycodone and with placebo in subjects who have had a bunionectomy.   "
210963|NCT00613951|"     This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble     Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each     other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive     subjects with type 2 diabetes.   "
210965|NCT00613977|"     The investigators wish to compare the difference in both cost and time to result for     determining fetal lung maturity for the Lamellar Body Count method and the Fetal Lung     Maturity II. Our hypothesis is that the time to result will be significantly less using the     Lamellar Body Count method, and the cost associated with this method over the traditional FLM     II will be favorable.   "
210966|NCT00614003|"     Most dying cancer patients would prefer a home death yet die in an institution. Patients can     experience uncertainty when weighing practical considerations, concern for others, and their     personal ratings about the desirability and undesirability of various outcomes related to     different locations of care. Health professionals, trained in decision support, can help     patients to make decisions that are informed by both relevant information and what outcomes     are most valued by patients. Therefore, I will study if an educational intervention can help     nurses and case managers to strengthen their skills and confidence in providing patient     decision support around place of end of life care.      Project Description:      Using a two step approach I will study if the quality of providers decision support can be     improved with an education. In step one nurses and care coordinators will be interviewed to     identify factors that make it easier or more difficult to provide patient decision support.     This information will be used to develop an education program. In step two, nurses and care     coordinator volunteers will be assigned by a flip of a coin to either receive the decision     support education or not. Before and after the education program the quality of the decision     support participants provide will be measured and compared. As well, participants receiving     the education program will be asked about their satisfaction with the education program.   "
210967|NCT00614016|"     A safety and pharmacokinetic study of a single dose of ST20 in healthy volunteers   "
210968|NCT00614029|"     A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the     Intraject system.   "
210969|NCT00614042|"     The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients     with previously treated chronic lymphocytic leukemia, and to obtain an estimate of clinical     activity in patients with CLL and non-Hodgkin's lymphoma.   "
210970|NCT00614055|"     This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC,     insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all     in combination with metformin in insulin naive subjects with type 2 diabetes.   "
210971|NCT00614068|"     This study will compare the effectiveness of trauma-focused cognitive behavioral therapy     versus standard care in treating children with post-traumatic stress disorder.   "
210972|NCT00614081|"     The aim of the study is to optimize and validate this MR-based GFR measurement in patients     with a renal transplant, compared with the reference method, the Cr51- EDTA method: to select     the most accurate combination of post-treatment of renal MR images and then evaluate its     intra- and inter-rater reliability.   "
211250|NCT00609284|"     The aim of the trial is to study the efficacy of adding concomitant chemotherapy     (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck     cancer.   "
210973|NCT00614094|"     The purpose of this retrospective pilot study is to assess the association of maternal     hypoglycemia during the one hour glucose tolerance test with decreased placental weight and     identifiable placental pathology. We hypothesize that a decreased one hour glucose tolerance     test is a risk factor for decreased placental weight, an increased fetal to placental weight     ratio, and other identifiable placental pathology.   "
210974|NCT00614107|"     A form of irregular heart rate called, Atrial Fibrillation (AF) is a major clinical problem.     It afflicts about 2 million Americans and is the single largest heart related cause of     stroke. However, despite 120 years of speculation and research, the mechanisms that cause AF     are poorly understood. Acute AF is also the most common irregular heart rate after open-heart     surgery in patients. This is seen in as many as 30% of such patients and often results in a     longer hospital stay.      In this study we would like to study the pattern of atrial fibrosis (scar tissue in the     heart) and an associated blood marker (a protein called pro-collagen-1) in those patients     concurrently having open heart surgery.   "
210975|NCT00614120|"     This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic     control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes   "
210976|NCT00614133|"     Loss of muscle mass and body protein are the main causes of fatigue after bowel surgery,     which may result in a longer hospital stay and a higher rate of complications. This     particularly applies to malnourished patients with cancer who undergo surgery with less     muscle protein reserves than patients who are well-nourished. Anesthesiologists can     favourably influence these undesirable consequences of surgery by choosing the type of pain     treatment, i.e. analgesia. Our group recently observed that pain treatment with epidural     catheters (these are placed in the so called epidural space, which lies between the spine and     the skin of the back), in contrast to the more conventional use of intravenous morphine, can     prevent the loss of body protein after surgery.      The goal of the present research program is to study whether this protein sparing effect of     epidural analgesia can be further augmented if we feed our patients intravenously with     glucose and protein starting the day prior to surgery. We believe that this new concept will     not only avoid the increased protein loss after surgery, but will also help patients to build     up new protein which is needed to fight the stress caused by the operation.   "
210977|NCT00614146|"     The objective of this trial is to evaluate the impact of elimination of albumin bound     substances during albumin dialysis (MARS®) on mortality and the clinical time course in     patients with a recent severe clinical deterioration of chronic liver disease caused by a     precipitating (trigger) event within 4 weeks manifested by jaundice, encephalopathy and/or     renal failure.   "
210978|NCT00616382|"     Persistent postnatal ductal patency may have significant adverse hemodynamic effects,     frequently necessitating therapeutic intervention in order to facilitate ductal closure.     Medical therapy for patency of the ductus arteriosus is successful mediating ductal closure     in approximately 70% of treated infants. In a recent study in our population, 17% of the     babies showed no ductal response to the first course of treatment and 9.4% of our study     infants eventually underwent surgical ligation of the ductus after failure of medical     therapeutic closure.We propose to evaluate and compare two alternate therapeutic approaches     to ductal closure in babies who do not respond to initial therapy.   "
211025|NCT00617006|"     We hypothesized that by improving hand hygiene compliance in the operative environment, we     would reduce horizontal transmission of pathogenic bacteria to surgical patients.   "
210979|NCT00616395|"     The purpose of this study is to characterize physical growth, body composition, dietary     intake, neurobehavioral development, and brain function of infants and children fed mostly     breast-milk, milk-based formula or soy-based formula during their first year of life.     Children are followed from age 2 months to age 6 years.   "
210980|NCT00616408|"     In the last two decades, somatostatin analogs have become a cornerstone of medical therapy     for acromegaly. One year of treatment with octreotide-LAR (LAR) controls GH and IGF-I excess     in 54% and 63% of unselected patients, with an increasing proportion of subjects achieving     IGF-I normalization prolonging the treatment. Clinically significant tumor shrinkage (20-30%     vs. baseline) has also been reported, with a higher proportion in patients treated first-line     [231 of 448 patients (52%)] than in those treated after surgery and/or radiotherapy [52 of     248 patients (21%)]. The highest rate of clinically significant shrinkage (>20%) occurred in     patients treated first-line with LAR (80%) as compared to the short-lasting octreotide     formulation (50%) or lanreotide slow-release formulation (35%. In 99 de novo patients with     acromegaly, we recently reported control of GH levels in 57.6%, of IGF-I levels in 45.5% and     a greater than 50% tumor shrinkage in 44.4% after 12 months of first-line treatment with     somatostatin analogues, either LAR or lanreotide. Besides the different drug used, the     duration of treatment also plays an important role on the shrinkage magnitude. In a     homogeneous cohort of 56 patients treated with LAR only and continuously for 24 months, we     noted an even more sustained effect on tumor shrinkage: overall, tumor volume decreased by     68.1±16.5% using dosages up-titrated to 40 mg every 28 days.      Despite this evidence, there is still a debate on the use of first-line treatment with     somatostatin analogues. Of paramount importance would be the possibility to predict the     results of one year treatment early after treatment beginning. Controversy has been reported     on the predictive value of initial tumor size, inhibition of GH and IGF-I levels during     treatment, and dose or type of the somatostatin analogue used during treatment. We found that     percent suppression of IGF-I after 12 months of LAR treatment was the parameter that best     predicted the amount of tumor shrinkage after the same period, but did not investigate the     results of short-term treatment in the same series.      This observational, analytical, open, retrospective study was designed to evaluate the     predictive value of tumor shrinkage, GH and IGF-I suppression after 3 months of     Octreotide-LAR (LAR) on tumor shrinkage obtained after 12 months. As secondary parameters we     also studied baseline patients profile such as age of diagnosis, gender, estimated disease     duration, GH and IGF-I levels and tumor size.   "
210981|NCT00616421|"     To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given     to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein     conjugate vaccine.   "
210982|NCT00616434|"     The primary objective of the study is to evaluate the clinical activity of interferon beta-1a     in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this     study are to determine (i) the safety and tolerability of interferon beta-1a in participants     with moderate to severe UC, and (ii) the percentage of participants, with a decrease in the     Simple Clinical Colitis Activity Index (SCCAI) score of ≥3 points at Week 8.   "
210983|NCT00616447|"     This study will compare the change detected by a standardized rating scale (Hamilton Anxiety     Rating Scale) scores in the active treatment group as compared to sham (placebo) group after     6 weeks of rTMS treatments. It is hoped that 6 weeks of rTMS treatment will lead to     improvement of core symptoms in patients with GAD.   "
210984|NCT00616460|"     To determine the safety/efficacy of Bivallirudin Vs unfractionated heparin (UFH) on top of     dual antiplatelet therapy in patients with high tendency for bleeding during urgent and     elective PCI.   "
210986|NCT00616486|"     Low frequency (1Hz) rTMS applied bilaterally and simultaneously over SMA for 6 weeks in     addition to the standard treatment regimen for OCD, will lead to significant improvement in     patients' symptoms. The clinical improvement detected by YBOCS, CGI and SF-36 QOLS scores     will be statistically significant in active treatment group compared to sham (placebo)     treatment group.   "
210987|NCT00616499|"     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with     stage IIIA non-small cell lung cancer.   "
210988|NCT00616512|"     The Purpose of the GF Strong water protocol is to allow clients who have thin liquid     dysphagia to drink water under certain specified conditions according to the rules of the     water protocol. Water Protocols have been shown to improve client satisfaction, and     hydration. We wish to assess this in a randomized, controlled fashion, and this is a pilot     project to determine feasibility.   "
210989|NCT00616538|"     Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed.     EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does     not contain corticosteroids or other anti-inflammatory drugs. The objective of the present     study is to demonstrate the safety and efficacy of EpiCeram ™ in the treatment of moderate to     severe atopic dermatitis as compared to mid-strength topical steroid cream following twice     daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients     lies in the potential for EpiCeram ™ to provide restoration of the normal skin barrier as     shown in previous studies and eliminate or reduce the requirement for supplemental topical     steroid administration.   "
210990|NCT00616551|"     The purpose of this study is to assess the biological safety and efficacy of using the drug,     C2L-OCT-01 PR, 30 mg to treat acromegalic patients.   "
210991|NCT00616564|"     High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998.     Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol     will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions     discussed above.   "
210992|NCT00616577|"     Caudal epidural analgesia (caudal block) is used in standard pediatric anesthesia practice.     It has been shown to be effective in managing postoperative pain in children undergoing     abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown     that children receiving caudal blocks have secondary benefits such as lower narcotic and     anesthetic requirements, more rapid awakening from general anesthesia, decreased time to     discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias     et al 1995, Tobias 1996).      This proposed study involves the use of a caudal block in children undergoing elective     inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in     pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a     caudal block before the onset of a painful stimulus, we can decrease central nervous system     sensitization and reduce postoperative analgesic requirements.   "
211026|NCT00617019|"     The purpose is to explore the frequency of impulse control disorders in Parkinson's patients     treated with different Parkinson's medications.   "
210993|NCT00616590|"     RATIONALE: Learning about insomnia and quality of life in patients undergoing chemotherapy     and radiation therapy for cancer may help doctors learn about the effects of treatment and     plan the best treatment.      PURPOSE: This clinical trial is studying insomnia in patients undergoing chemotherapy and     radiation therapy for head and neck cancer.   "
210994|NCT00616603|"     Dexamethasone is a commonly used steroid. This medication has been used for many years by     physicians for many different indications. Recent articles, multiple case reports, and     experience at this institution have indicated that dexamethasone successfully prolongs the     effective duration of local anesthetics for regional blocks. This can cause a significant     reduction in postoperative pain and the decreased need for postoperative narcotics. Although     other adjuncts can be used for prolonging nerve blocks, epinephrine causes local     vasoconstriction which can cause ischemia and nerve damage in a large nerve such as the     sciatic nerve.Dexamethasone will not cause this problem and yet could prolong the duration of     a sciatic nerve block. Therefore, the goal of this study is to prospectively evaluate the     effectiveness of dexamethasone, both locally through the nerve block and systemically via IV     administration, in prolonging the effective duration of local anesthetics when used in     sciatic nerve blocks.   "
210995|NCT00616616|"     Laparoscopic surgery being performed with only one small incision via the umbilicus (belly     button).   "
210996|NCT00616629|"     The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological     properties and intracardiac pressures   "
210997|NCT00616642|"     RATIONALE: Rosiglitazone may help pituitary adenoma cells become more like normal cells, and     grow and spread more slowly.      PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients     with newly diagnosed or residual or recurrent pituitary adenoma.   "
210998|NCT00616655|"     To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized     anxiety disorder (GAD).   "
210999|NCT00616668|"     The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to     Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and     the process of rehabilitation.   "
211000|NCT00616681|"     The objective of this study was to assess the bioequivalence of a potential generic 600 mg     oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine     tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.   "
211001|NCT00616694|"     To evaluate the effect of subject knowledge of their disease status on persistence in     subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment     of GIO.   "
211002|NCT00616707|"     The purpose of this study is to determine if there are signs of inflammation in one's blood     and urine and to find out if one's body size or ethnicity has an effect on these substances.   "
211275|NCT00609622|"     This study will compare the safety and efficacy of sunitinib in combination with FOLFOX     versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic     colorectal cancer who have not been treated before.   "
211003|NCT00616720|"     RATIONALE: Biological therapies, such as interferon-gamma and aldesleukin, may stimulate the     immune system in different ways and stop cancer cells from growing. Vaccines made from a     person's white blood cells may help the body build an effective immune response to kill     cancer cells. Giving biological therapy together with vaccine therapy may kill more cancer     cells.      PURPOSE: This randomized phase II trial is studying how well giving aldesleukin or interferon     gamma together with vaccine therapy works in treating patients with multiple myeloma.   "
211004|NCT00616733|"     This is a 12-week study to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.   "
211005|NCT00616746|"     The purpose of this study is to characterize the interactive effects of acute intravenous     (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use     alcohol.   "
211006|NCT00616759|"     Participating subjects are those who are referred for electroconvulsive therapy (ECT) for     severe depression who have agreed to the protocol. The control group receives ECT as usual.     The other group receives propofol to terminate the ECT-induced seizure timed so that the     seizure lasts at least 25 seconds. Extensive neuropsychological testing is being done on both     groups before beginning ECT and within 48 hours after the 6th treatment. Multiple markers of     the rapidity of recovery from anesthesia are being obtained from all subjects for 6 ECTs.   "
211007|NCT00616772|"     The primary purpose of this study is to test the effect and safety of once daily ABT-335 on     the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients     with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol     (bad cholesterol) after taking atorvastatin.   "
211008|NCT00616785|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving     combination chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with radiation therapy works in treating patients with stage III non-small cell lung cancer     that cannot be removed by surgery.   "
211009|NCT00616798|"     This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia     who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone,     paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms.     After a 4 week run in period on their current anti psychotic treatment, patients will be     randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on     therapy. The anticipated time o n study treatment is <3 months, and the target sample size is     100-500 individual s.   "
211010|NCT00616811|"     This clinical trial is designed to provide additional information on the safety and     tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in     patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular     filtration rate (GFR) < 30 mL/min) for a period of 24 weeks.   "
211079|NCT00617747|"     The purpose of this study is to evaluate the effectiveness and tolerability (the ability not     to experience ill effects from the study drug) of a zolmitriptan nasal spray, 5.0 mg,     compared with placebo (inactive drug) for 2 migraine headaches for up to 12 weeks in adult     subjects with migraine headaches   "
211164|NCT00618878|"     The purpose of the study examines the use of electroacupuncture and laser therapy to treat     chronic neck pain.   "
211011|NCT00616824|"     This study intends to compare postoperative outcomes of a tissue expander placement following     a mastectomy with two different operative techniques. This study will be randomized and     double blinded comparing the traditional placement of the tissue expander under an     inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix     as an inferolateral sling, instead of the muscle flap.      The study we are proposing will evaluate the question of whether there is a difference     between the traditional method of serratus flap and the new technique of using an acellular     matrix with tissue expander placement. This will be a double blinded randomized study of     thirty women in each group comparing outcomes which will include postoperative pain,     complications (wound infection, hematoma, capsular contracture, etc), and patient     satisfaction with the procedure.   "
211012|NCT00616837|"     Patients from 4 local communities in northern Norway referred (either new or follow up) to     orthopaedic department, University hospital of Northern Norway for outpatient consultation,     are randomly assigned to either remote consultation by use of telemedicine (camera and     screen), or standard consultation at the hospital. There are x-ray facilities also at the     remote site. The patients randomized to telemedicine consultation meet special trained nurses     at the remote site, but doctor only by video conference. The patients will be followed for up     to one year. The primary endpoint is quality of care achieved with the telemedicine     consultation as compared to standard outpatient consultation (assessed by questionnaires     filled out by the doctor involved). Secondary end points are patient satisfaction assessed by     questionnaires and economic analyses. The study hypothesis is non-inferiority of telemedicine     consultation vs. conventional, outpatient consultation.   "
211013|NCT00616850|"     Total knee replacement is often associated with severe postoperative pain, especially in the     first 24 hours. Patient controlled analgesia (PCA) and continuous femoral block with PCA are     commonly used to treat postoperative pain after total knee arthroplasty. However, PCAs use     opioids. Opioids are excellent painkillers but their use is hampered by side effects such as     nausea, vomiting, bowel dysfunction, urinary retention, pruritus, sedation and respiratory     depression. We propose to test the hypothesis that adding a low dose lidocaine infusion to     PCAs will lower the amount of opioids that these patients receive, thereby improving patient     safety while still providing adequate analgesia. In addition, continuous femoral block has     been shown to provide superior postoperative pain control when compared to morphine PCA.     Therefore, postoperative pain levels of study subjects will be compared to those subjects who     receive a combination of a continuous femoral block catheter with a PCA.   "
211014|NCT00616863|"     The objective of this study was to assess the bioequivalence of a potential generic 600 mg     oxcarbazepine tablet formulation with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet,     Trileptal, folloiwng a single 600 mg dose administered with food.   "
211016|NCT00616889|"     Clinical practice indicates that Quetiapine has sedating properties, and its sedative effects     may play an important role in restoring quality of sleep in patients with various psychiatric     conditions who frequently experience sleep disturbances as part of their illness. It is well     known that depressive disorders are very frequently associated with significant sleep     disturbance. Sleep disruption is a feature of Bipolar Disorder during both Depressed and     Manic/Hypomanic episodes. Considering that Seroquel has good antidepressant properties     (Calabrese, 2004), the investigators suggest that Seroquel's effect on sleep architecture     contributes to its antidepressant properties.   "
211017|NCT00616902|"     To evaluate the effects of paricalcitol injection on cardiac structure and function over 48     weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have     left ventricular hypertrophy (LVH).   "
211018|NCT00616915|"     Wellbutrin (bupropion) is an effective antidepressant (Thase, M 2005). It exists in instant     release (IR), sustained release (SR) and extended release (XL) forms. The IR formulation was     never approved for use in Canada. The XL formulation allows for once daily dosing.      Wellbutrin is both a norepinephrine and dopamine reuptake inhibitor, and as such increases     the synaptic concentration of both neurotransmitters. This adds to its positive effects on     cognition, apathy, tiredness and executive functioning. The increased activation may be also     responsible for some of its side effects such as initial insomnia and reduced sleep     efficiency, especially when taken at night.   "
211019|NCT00616928|"     The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to     characterize the immunogenicity & safety of the investigation vaccination regimen of GSK     1557484A vaccine given to adults aged ≥18 years.   "
211020|NCT00616941|"     This is an open label, Phase I study of vaccination with NY-ESO-1 OLP4 with or without     immunoadjuvant Montanide and Poly-ICLC in patients with epithelial ovarian, fallopian tube,     or primary peritoneal cancer in second or third clinical remission.      The primary and secondary endpoints of the study are to determine the safety and     immunogenicity of NY-ESO-1 OLP4 vaccination with or without immunoadjuvants Montanide and     Poly-ICLC.   "
211021|NCT00616954|"     This study is planned to evaluated whether ATG is needed in haploidentical stem cell     transplantation   "
211022|NCT00616967|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help     carboplatin and paclitaxel albumin-stabilized nanoparticle formulation work better by making     tumor cells more sensitive to the drugs. Giving chemotherapy with or without vorinostat     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs     to be removed.      PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with     paclitaxel albumin-stabilized nanoparticle formulation works with or without vorinostat in     treating women with breast cancer that can be removed by surgery.   "
211023|NCT00616980|"     The purpose of this study is to evaluate the safety and efficacy of intramuscular injections     of adult stem cells in patients with Critical Limb Ischemia (CLI).   "
211027|NCT00617032|"     Study 1304 is a Phase I dose escalation study conducted in adults with persistent moderate     (grade 2) or severe (grade 3) swelling due to inflammatory arthritis (rheumatoid arthritis,     psoriatic arthritis, or ankylosing spondylitis) in at least one peripheral joint eligible for     injection. Disease must not be severe enough to warrant use of a TNF-alpha antagonist in the     next three months.      Current use of TNF-alpha antagonists is not permitted. Subjects with rheumatoid arthritis     must have had an adequate trial of at least one disease-modifying antirheumatic drug (DMARD)     prior to screening.      The primary objective is to evaluate the safety of intra-articular administration of tgAAC94.   "
211028|NCT00617045|"     The purpose of this study is to assess whether the antidepressant, duloxetine, is equally     effective as a treatment for subjects who have a Postpartum Onset Depression compared to     subjects who have an onset of Major Depressive Disorder prior to delivery. The hypothesis is     that duloxetine will be as effective in subjects with Postpartum Major Depressive Disorder as     in subjects with a Major Depressive Disorder.   "
211029|NCT00617058|"     The purpose of this study is to evaluate the relative risks and benefits of two approaches to     the control of weight gain and other negative side effects in children and adolescents on 2nd     generation antipsychotics (SGA):        -  Healthy lifestyle instruction (nutritional and physical activity surveillance and          advice) + continuation of current SGA;        -  Add the diabetes drug, metformin + continuation of current SGA.   "
211030|NCT00617071|"     RATIONALE: Developing a personalized screening plan may be more effective than usual care in     increasing the number of healthy participants who regularly undergo screening for colorectal     cancer.      PURPOSE: This randomized phase III trial is studying personalized screening plans to see how     well they work compared with usual care in increasing colorectal cancer screening in healthy     participants.   "
211031|NCT00617084|"     The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm,     international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The     study is a real world, all comers study.      Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent)     system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac     death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion     Revascularization at 1 year in a real world patient population.   "
211039|NCT00617201|"     This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate     atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent     individuals, who are healthy and are seeking treatment for their substance abuse, will be     randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial     lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve     maintenance on the assigned active dose safely. Contingency management procedures will be     used to reinforce attendance and compliance with study procedures. Primary outcome measures     will include urinalysis data assessing cocaine use.   "
211040|NCT00617214|"     Purpose of this non-interventional study (NIS) is to assess the effect of the participation     in an integrated care program on treatment outcomes in patients treated with Seroquel for     schizophrenia.   "
211032|NCT00617097|"     The investigators primary objective is to study the analgesic effects of combined ketorolac     and lidocaine in a paracervical block compared to preoperative ibuprofen followed by     intra-operative paracervical block with lidocaine alone on women undergoing first trimester     surgical abortions. The investigators hypothesize that women who receive a paracervical block     of combined ketorolac and lidocaine will experience less pain during the procedure based on a     visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a     paracervical block with lidocaine alone.      This randomized, multi-site, placebo-controlled clinical trial will investigate the     difference in perceived pain from first trimester surgical abortions using a paracervical     block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical     block with lidocaine alone. A total of fifty women who are seeking elective surgical     abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited     from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore,     Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during,     and after surgical abortion will be measured using a 100-mm VAS.      The primary outcome of interest is the mean difference in pain level from preoperative     baseline to time after cervical dilation comparing the treatment groups. If the investigators     see greater pain reduction associated with the paracervical block of lidocaine and ketorolac,     adoption of this regimen may improve pain management during first trimester surgical     abortions. If combined ketorolac and lidocaine when administered as a paracervical block is     proven to be efficacious, the need for additional analgesia in first trimester surgical     abortions can be minimized.   "
211033|NCT00617110|"     Allergic rhinitis (AR) is a condition that exists when an individual with a specific allergy     reacts to that allergen resulting in a runny and/or stuffy nose, postnasal drip, and possible     symptoms of sneezing, scratchy throat, itchy nose, ears or throat. When the allergic person     is exposed to such an allergen, the body reacts with overproduction of certain chemicals     which cause inflammation and subsequent symptoms of AR. These responses are related to the     body's hyperreactive response to exposure to an otherwise harmless substance such as dust,     ragweed, pollen, cat dander etc.      There are data to suggest that air pollution resulting from diesel exhaust can increase the     body's response to airway inflammation caused by virus.      The purpose of this research study is to determine if individuals with AR have increased     inflammatory responses to flu virus following exposure to diesel exhaust (DE) vs exposure to     clean air compared to how individuals who do not have allergies respond to the same exposure     conditions. The hypothesis for this study is that diesel exhaust exacerbates LAIV-induced     allergic nasal inflammation, using controlled exposures in AR volunteers compared to     non-allergic individuals   "
211034|NCT00617123|"     This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in     participants with established atherosclerotic disease who are enrolled into the TRA 2°P -     TIMI 50 Study (P04737) (NCT00526474).   "
211035|NCT00617136|"     The investigators aim to investigate the effects of prewarming of patients undergoing     elective orthopedic surgery on intraoperative temperature control and blood loss and     postoperative patient discomfort and glucose and insulin levels.   "
211047|NCT00617305|"     To evaluate the change from baseline in pulmonary vascular resistance (PVR), and other     hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase     type-5 inhibitor (PDE-5i) therapy in subjects with pulmonary arterial hypertension (PAH) who     have demonstrated a sub-optimal response to PDE-5i monotherapy.      The study was originally designed as a 2-arm, double-blind, randomized study in which     patients received ambrisentan or placebo for 24 weeks, and then received ambrisentan blinded     to dose for 24 weeks. With Protocol Amendment 2 (12 June, 2009), the study was switched to     single-arm, open-label treatment, and all patients remaining in the placebo arm were switched     to open-label ambrisentan treatment. Patients who enrolled after Amendment 2 all received     open-label ambrisentan.   "
211165|NCT00618904|"     To determine if probiotics bacteria, specifically lactobacillus and bifidobacterium, improve     gastrointestinal symptoms in patients with IBS, functional diarrhea, or functional bloating.   "
211036|NCT00617149|"     Background:      Use of variable definitions of exercise and disparate results, emphasize the need of proper     randomized controlled trials examining the relationship between physical activity and weight     development during pregnancy. So far, only few intervention studies aiming at weight     management during pregnancy have been performed (Gray-Donald et al., 2000,Olson et al.,     2004,Polley et al., 2002,Kinnunen et al., 2007). Moreover, most of these interventions have     focused on how gestational weight gain may be altered through individual counselling     combining diet and exercise habits, rather than supervised training. Search on PubMed     revealed no randomized controlled trial where the main outcome was to investigate how the     effect of supervised structured exercise may reduce the proportion of women gaining more     weight than optimal. The aim of the present study is to assess whether a 12-week aerobic     exercise program during pregnancy can prevent excessive gestational weight gain.      Method:      This is a single blind randomized controlled trial to evaluate the effects of a structured,     supervised aerobic exercise program on weight gain stabilization in primiparous pregnant     women. The aim is to include 100 women. Interested women eligible for the present study will     be invited to a pre-test including interview and assessments at the university. The women are     examined three times during the study period. The first visit is between 12 and 24 weeks of     gestation, the second at week 36-38 and the last 8-12 week after delivery. The exercise     program consists of supervised exercise for 60 minutes, performed at least 2 times per week,     for 12-16 weeks. Compliance with the training protocol is controlled by the instructors and     registrations in the womens personal training diary   "
211037|NCT00617175|"     To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered     for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a     consequence of self-termination and better arrhythmia discrimination due to a greater number     of R-R intervals necessary to detect ventricular events.   "
211038|NCT00617188|"     RATIONALE: Estrogen can cause the growth of ovarian epithelial cancer cells. Hormone therapy     using fulvestrant may fight ovarian cancer by blocking the use of estrogen by the tumor     cells.      PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with     recurrent ovarian epithelial cancer.   "
211041|NCT00617227|"     The study is based on the hypothesis that decreased creatinine clearance may be associated     with detectable vancomycin levels in patients on enteral (oral / vancomycin enemas)     vancomyicn for CDAD.      The objective of the study is to see whether enteral vancomycin is absorbed through the     inflamed GI mucosa in CDAD, and if it is absorbed, does it achieve measurable serum     concentration.   "
211042|NCT00617240|"     The purpose of this pilot study is to determine whether starting metformin in conjunction     with a second-generation antipsychotic (SGA) and providing information about healthy eating     and activity will prevent or reduce the amount of weight gain and the metabolic changes in     adolescent youth typically seen with second-generation antipsychotic medication.   "
211043|NCT00617253|"     This phase 1/2a trial is conducted in Europe. The first part of the trial is a dose     escalation safety trial determining the maximum tolerated dose of rIL-21 when administered in     combination with sunitinib.      The second part, scheduled to start in September 2008, is a randomised 2-arm trial comparing     the anti-tumour effect of rIL-21 plus sunitinib with sunitinib alone.   "
211044|NCT00617266|"     The Business Process Outsourcing BPO industry has been rapidly expanding in India over the     last 10 years. There is a concern regarding issues of health and safety that are unique to     this new and developing industry. The lack of reliable and relevant information on which to     base the response to this concern poses a challenge for safeguarding the health of BPO     employees. Elevated stress levels, shift duties, high work targets, lofty income may force     many towards addictions to keep them going.      Use of tobacco, which is very common addiction in India, is associated with several health     hazards. Anecdotal evidence suggests that smoking and other forms of addictions are at its     peak in the BPO industries. We are conducting a research on the tobacco habits among Business     Process Outsourcing (BPO) employees to understand the prevalence of different forms of     tobacco addiction and the reasons for initiation and continuation of the habit. We will also     offer different interventions as a measure of tobacco cessation.   "
211045|NCT00617279|"     The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than     disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12     months.   "
211046|NCT00617292|"     Congenital adrenal hyperplasia (CAH) is a genetic disorder that affects the amount of     steroids that the body forms. The most common form of CAH is 21-hydroxylase deficiency     (21OHD), which leads to cortisol deficiency and causes the development of mature masculine     characteristics in newborn, prepubescent, and grown females, and prepubescent males. Prenatal     treatment with dexamethasone, a corticosteroid, has been shown to reduce the masculinization     of genitalia. However, the long-term effects of dexamethasone on the children who received it     as fetuses and on mothers who were exposed to it while they were pregnant have not been     determined. This study will investigate potential long-term adverse side effects of prenatal     dexamethasone treatment in children and young adults who received dexamethasone as fetuses     and their mothers who were exposed to it during pregnancy.   "
211109|NCT00618137|"     The main objective of the study is the exploration of the natural course of COPD and its     biological background. To this end, active workers without COPD and workers in functional     classes GOLD 0-III are investigated by a combined clinical and molecular approach. The study     has been designed as a prospective, intraindividual pilot in 160 male or female volunteers of     the greater Vienna Area over a period of three years for each individual volunteer.   "
211048|NCT00617318|"     Pomegranate has a long history of use in folk medicine. There is vast data on the health     benefits of pomegranate fruit and juice. Multiple studies have established the strong     antioxidative effects of pomegranate polyphenols (primarily the ellagitannin punicalagin) and     their health effects. A vast number of animal and human clinical studies have provided     evidence on effect of pomegranate products on improving blood lipid profile, reducing blood     pressure, improving endothelial function, anti-tumor activity, and its anti-atherosclerotic     activity. We studied the protective effect of a pomegranate concentrate (POM Flu and Cold     Formula®) in decreasing the incidence and duration of influenza-like illnesses and common     cold among healthy adults.   "
211049|NCT00617331|"     The purpose of this research study is to determine whether prior exposure to A/H2N2 viruses     is associated with better antibody (part of the immune system that fights infection)     responses after vaccination with an A/H9N2 flu vaccine. The study will evaluate how much     antibody is made to the influenza virus after H9N2 flu vaccination and how the body reacts to     different strengths of the H9N2 flu vaccine. This information may guide vaccine development     for this virus as well as other bird flu viruses that have infected humans. Study     participants will include 120 healthy subjects, age 18-38 or 44-59 years. Two different     dosages of vaccine will be given in the muscle of the upper arm about 1 month apart. The     assignment of vaccines to participants is governed by chance. Study procedures may include     medical history, physical exam, and blood samples. Study participation duration is about 7     months.   "
211050|NCT00617344|"     This is a follow up study using three different formulations for each serotype with the aim     of testing immunogenicity and reactogenicity      Primary Objective:      Immunogenicity: To evaluate immunogenicity by neutralizing antibody response post dose 2.      Secondary Objectives:      Safety: To evaluate safety following three formulations of ChimeriVax™ Tetravalent Dengue     Vaccine.      Immunogenicity: To describe the neutralizing antibody responses after each dose.   "
211051|NCT00617357|"     This is a prospective, multicenter, interventional, observational, open label, single arm,     longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or     infected sites. Three interim analyses are planned to examine the incidence of surgical site     events, postoperative resumption of activities and hernia recurrence.   "
211070|NCT00617617|"     The purpose of this research study is to determine if giving men with early stage (Grade 1-2)     prostate cancer dietary supplement from soybeans called isoflavones, will change their blood     hormone levels. Isoflavones are substances found in a high concentration in soybeans that are     converted in the intestines to hormone-like compounds which are similar to estrogen. They are     also thought to have cancer fighting properties. Clinical trials suggest that isoflavones can     increase certain sex hormones, which results in the slower production of prostate cancer     cells. This study will determine if adding isoflavones (supplied as Prevastein HC®) 80 mg/day     in a pill form can change your risk factors that cause early stage prostate cancer to     progress to more advanced disease.   "
211052|NCT00617370|"     The purpose of this study is to give a drug regimen that is hoped to be effective in     preventing cancer from coming back. Since it is an aggressive breast cancer, there is a     moderate to high chance that the cancer may come back. The standard treatment for this tumor     type includes a chemotherapy regimen with drugs named epirubicin (E) and cyclophosphamide (C)     in a vein every 2 weeks for 4 treatments, followed by a drug named paclitaxel, every 2 weeks     in your vein for 4 treatments.      This study is an experimental study in which you will be given 6 cycles of EC followed by 6     cycles of paclitaxel. The purpose of getting 2 more cycles of EC and 2 more cycles of     paclitaxel than what is normally given is to study a regimen that may be more effective than     the current standard treatment in preventing the recurrence of this cancer. Specifically, in     this study we are looking for side-effects and risks of these drugs as more cycles are given.   "
211053|NCT00617383|"     The definition of the most 'at-risk' population within highly susceptible groups would     provide an opportunity for preemptive therapeutics.      A convenient, safe, and tolerable therapy that delays the onset of clinical disease during     the pre-symptomatic stage of demyelinating disease would provide a therapeutic alternative to     a 'wait and see' approach in subjects at 'high risk' for CIS (clinically isolated syndrome -     monosymptomatic demyelinating disease) or MS.      Identical twins share the same genes and have the highest rate of shared MS. An identical     female with a sister twin with MS has a 34% chance of having MS. Non concordant (no MS yet)     identical (monozygotic - from the same sperm-egg zygote) female twins provide an ideal     population to find out what factors predict the onset of MS in the non-affected twin.      We will recruit 30 identical female twins, one with MS and the other without MS, and obtain     brain MRI and biological samples on the non-affected twin and determine if:        -  the presence of characteristic MS-like lesion(s) on baseline MRI predisposes to MS.        -  specific proteins in blood or cerebrospinal fluid predispose to the clinical expression          of demyelinating disease      If we can predict by simple tests (MR brain scan and blood tests) the likelihood of the onset     of MS in 'at risk' subjects, and have safe and tolerable therapies, we may be able to prevent     the clinical onset of demyelinating disease (MS).   "
211054|NCT00617396|"     Purpose: We are proposing to examine, via open label trial, the use of Seroquel® for patients     with moderate to severe functional bowel symptoms who are not receiving adequate relief from     their symptoms on their present regimen of SNRI or TCA antidepressant agents.      Participants: Primary eligibility will be determined of patients at The UNC Center for     Functional GI & Motility Disorders Clinic who score in the moderate to severe range on the     Functional Bowel Disorders Severity Index (FBDSI ≥ 37) who have failed or have incomplete     treatment responses of medications including at least one prior trial of antidepressant     medication.      Procedures (methods): We will monitor several patient and symptom related outcomes, as well     as evaluate health related quality of life, psychological distress and related psychosocial     measures to determine if the addition of Seroquel® over and above the use of an     antidepressant improves clinical response based on an adequate relief measure as well as     selected secondary outcomes. We will also determine when treatment benefit is related to     effects on pain, the associated psychological co-morbidities seen in this population, or both     factors.   "
211055|NCT00617409|"     The purpose of this research study is to test a tumor (cancer) vaccine given along with     chemotherapy to determine if this vaccine will increase the chances of the tumor shrinking     and/or the amount of time that people who have this disease will live.   "
211056|NCT00617435|"     The investigators' project has as for principal objective to understand the impact of trans     fatty acids from dairy products and industrial origin on the development of insulin     resistance in obese woman. Because of the different isomeric position of the double bound     those trans fatty acids may have different metabolic effects.   "
211110|NCT00618150|"     Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit     from an educational program explaining the medical aspects of the disease, self-management     strategies and how to deal with health services. We hypothesized that patients having     participated in an educational program would experience an improved quality of life when     compared to patients who did not take part (controls).   "
211057|NCT00617448|"     The objective of this prospective randomised trial was to compare the short- and long-term     efficacy of conventional diathermy haemorrhoidectomy versus Ligasure™ diathermy, and to     assess the short-term outcome of each procedure performed either under spinal anaesthesia or     local anaesthesia with pudendal block with ropivacaine combined with intravenous sedation.      We think, Ligasure haemorrhoidectomy under local anesthesia can be performed as day-case     procedure and with equal results at long-term than conventional diathermy (considered goal     standar of haemorrhoidectomy).   "
211058|NCT00617461|"     The purpose of this study is evaluate the difference between two doses of gabapentin     enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with     post-herpetic neuralgia.   "
211059|NCT00617474|"     The study hypothesis is that erythropoietin usage after kidney transplantation, in early     phase, can improve the outcome for patients and their graft increasing patient and graft     survival.   "
211060|NCT00617487|"     The purpose of this study is to evaluate the role of stress echocardiography, compared to     standard echocardiography in the early identification of pulmonary arterial hypertension in     systemic sclerosis. To evaluate the role of BNP in this setting.To analyze data recorded with     respect to the parameters commonly used for SSc evaluation (eg thorax HRCT, pulmonary     function tests + DLCO, nailfold capillaroscopy, etc); these parameters are available starting     for 1999.   "
211085|NCT00617825|"     Severe skin damage caused by chronic venous disorders (CVDs) results in relentless pain and     poor quality of life for millions of adults in the U.S. each year. DVDs are under-recognized     and under-treated disorders shat harm the veins of the legs and at worst, cause skin     inflammation and venous leg ulcers. A new way to ease the pain and inflammation is proposed     in this study of cryotherapy (cool gel wraps) applied to damaged skin of the lower legs of     CVD-affected individuals. The study hypothesis predicts that this novel cryotherapy model and     method will significantly improve the health and quality of life for those with CVDs and that     the intervention will become a standard of care for CVDs. In addition, the method will, over     time, reduce health care costs associated with treating poor CVD outcomes.   "
213397|NCT00646412|"     The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent     post-surgical adhesions after median laparotomy.   "
211061|NCT00617500|"     The alternative and complementary therapies are being gradually included in the Brazilian     Health Unique System (SUS), as it is foreseen in the National Politics of Integrative and     Complementary Practices in Brazil . However, though this thematic is also included in the     National Agenda of Research Priorities concerning Health, published studies concerning this     matter are quite scarce. The World Health Organization (WHO) indicated that it is a big     challenge to effect the following studies: cost-effectiveness, as well as safety, efficiency     and the quality of such practices. WHO also pointed out the clinical situations where they     could be applied and that is why this investigation we are undertaken is fully justified.      Annoying signs and symptoms which come along with the climacteric period, especially anxiety,     insomnia and hot flushes, change women´s life quality and their affective, social and     business relationships as well. Consequently, this can generate sadness, depression and     isolation.      Many women cannot undergo hormonal replacement, for several reasons: or they have some     illnesses which reject hormones, or due to hypersensitiveness reactions or even economical     difficulties. Also, the cost-effectiveness ratio between conventional therapy of hormonal     replacement and complementary therapies which compose this study are not known yet .      The complementary therapies proposed in this study concern non-invasive methods, of low cost,     which justify being researched in order to verify the potential of those annoying signs     alleviation.   "
211062|NCT00617513|"     The purpose of this study is to determine which dose of prucalopride is safe and effective in     patients with chronic idiopathic constipation.      Hypothesis:      Prucalopride 1 and 2 mg are safe and effective for the treatment of chronic idiopathic     constipation whereas 0,5 mg is a suboptimal dose.   "
211063|NCT00617526|"     The primary objective of the trial is:      • to evaluate the change from baseline in plasma viral load with placebo and one of up to 4     dose regimens of RDEA806.      The secondary objectives are:      Efficacy        -  to describe the nadir of the plasma viral load        -  to describe the DAVG        -  to assess the proportion of subjects who reached a drop in viral load of 0.5 log, 1 log,          or reach an undetectable viral load        -  to assess the plasma viral load decay rate        -  to evaluate immunologic changes (as measured by CD4 and CD8 cells)        -  to evaluate the genotypic and phenotypic pattern of the virus Pharmacokinetics        -  to evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of          RDEA806 Safety        -  to evaluate the safety and tolerability of bid and qd dosing of RDEA806 as monotherapy   "
211064|NCT00617539|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving irinotecan together with     temozolomide and to see how well it works in treating patients with breast cancer who have     received previous treatment for brain metastases.   "
211065|NCT00617552|"     The purpose of this study is to determine whether TZP-101 is effective in the management of     post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large     bowel resection).   "
211066|NCT00617565|"     This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of     biphasic insulin aspart 30 on postprandial glycaemic control.   "
211067|NCT00617578|"     Many arrhythmias detected in the ventricular fibrillation (VF)-zone picture monomorphic     ventricular tachycardia (VT) and, hence, could be terminated by antitachycardia pacing (ATP)     treatment. Advantages of successful ATP are the painlessness termination and the shortened     duration of arrhythmia. The ATP One Shot algorithm is integrated in the latest family of     implantable cardioverter defibrillators (ICDs) from BIOTRONIK (Lumax). It allows a single     delivery of ATP before charging capacitors to terminate lethal arrhythmia by painful shock.      The present study evaluates the efficacy of the ATP One Shot algorithm for the termination of     fast VT episodes. 200 patients with secondary prophylactic ICD indication will be followed     for 18 months. Spontaneous episodes detected in the VF-zone of the ICD will be evaluated with     regard to cycle length, episode duration and course of device therapy.   "
211076|NCT00617708|"     This randomized phase I/II trial is studying the side effects and best dose of monoclonal     antibody therapy when given together with gemcitabine hydrochloride and erlotinib     hydrochloride and to see how well they work compared with giving gemcitabine hydrochloride     and erlotinib hydrochloride alone as first-line therapy in treating patients with metastatic     pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies can block tumor growth in different ways. Some block the ability of tumor cells to     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances     to them. Giving erlotinib hydrochloride and gemcitabine hydrochloride together with     monoclonal antibody therapy may kill more tumor cells.   "
211068|NCT00617591|"     The purpose of the research study is to determine the response rates when Revlimid® is     combined with Doxil® and Dexamethasone (Dd-R) in newly diagnosed Multiple Myeloma. The study     will also evaluate the side effects caused by the combination of these three drugs. This     therapy is investigational in the treatment of Multiple Myeloma.      Revlimid® is a drug that alters the immune system and it may also interfere with the     development of tiny blood vessels that help support tumor growth. Therefore, in theory, it     may reduce or prevent the growth of cancer cells. Revlimid® is approved by the Food and Drug     Administration (FDA) for specific types of myelodysplastic syndrome (MDS) and Multiple     Myeloma, two different types of blood cancer. It is currently being tested in a variety of     other cancer conditions. In this case it is considered experimental.      Doxil® is a form of chemotherapy. It is approved by the FDA for the treatment of relapsed/     refractory Multiple Myeloma in combination with Velcade.      Dexamethasone is a steroid. It is also approved by the FDA, but not for the treatment of     Multiple Myeloma. It is considered a standard part of most myeloma therapies for newly     diagnosed patients.   "
211069|NCT00617604|"     The purpose of this study is to determine whether alefacept is effective and well tolerated     when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a     combination therapy of placebo, tacrolimus and steroids in the prevention of kidney     transplant rejection.   "
211071|NCT00617643|"     Triomune is the most commonly prescribed treatment for HIV infection in Uganda. Triomune is     manufactured by a generic drug company and consists of three drugs combined in a single pill     given twice daily (stavudine 30mg plus lamivudine 150mg plus nevirapine 200mg).      It is known that the levels of nevirapine in a patient's blood are highest in the first two     weeks of treatment. Therefore it is recommended that patients starting on nevirapine should     undergo dose escalation i.e start on 200mg once daily for two weeks and then increase to full     dose of 200mg twice daily in order to avoid nevirapine related rash. It is not possible to do     dose escalation with a fixed dose combination pill like Triomune and for the two weeks of the     dose escalation patients either can buy stavudine plus lamivudine plus nevirapine as separate     pills or take Triomune in the morning and then take stavudine plus lamivudine as separate     pills in the evening.      Rifampicin is used to treat TB and lowers the levels of nevirapine in a patient's blood. This     raises two questions in routine clinical practice for patients who are co-infected with HIV     and TB (1) Do we need to put our patients to the trouble of dose escalation of nevirapine if     they are already on rifampicin? and (2) If we dose escalate nevirapine in patients on     rifampicin, are we putting them at risk of low drug levels and development of resistance? The     aim of this study is to compare the plasma concentrations of nevirapine in HIV infected     patients who are commencing antiretroviral therapy with and without a lead in dose of     nevirapine and who are also receiving concomitant treatment with antituberculous therapy     which includes rifampicin to assess whether dose escalation of nevirapine is appropriate in     this patient population   "
211072|NCT00617656|"     Primary objective:      · Time to progression.      Secondary objectives:        -  Assess Overall survival of both treatment groups.        -  Assess Tumor response rate using RECIST criteria        -  Assess Toxicity profile of patients enrolled in the study.        -  Exploratory evaluation of potential genetic markers of response or resistance to          chemotherapy.   "
211073|NCT00617669|"     Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054     (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone     resistant prostate cancer (HRPC).      This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can     further improve survival compared with docetaxel alone.      ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread     by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054     (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with     docetaxel.      All patients participating in this clinical trial will receive docetaxel chemotherapy, which     is a commonly used chemotherapy to treat prostate cancer in addition to other existing     prostate cancer therapies.      Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive     placebo in addition to docetaxel and other prostate cancer therapy. By participating in this     trial there is a 50% chance that patients will receive an agent that may further slow the     progression of the tumour.      No patients will be deprived of standard prostate cancer therapy.   "
211074|NCT00617682|"     The main objective of this study is to evaluate whether immunization with 9-valent     pneumococcal conjugate vaccine (PNCRM9) during the third trimester of pregnancy interferes     with active antibody production in offspring immunized with PNCRM7 (Prevnar) in the first six     months of life.   "
211075|NCT00617695|"     The purpose of this study is to evaluate the effectiveness and safety of Zolmitriptan (Zomig)     nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches over a     3-month period in adolescent patients (aged 12 to 17 years) with migraine headaches   "
211077|NCT00617721|"     Purpose: Identification of the gene(s) involved in plasma membrane remodelling.     Identification of the circulating markers affected by the defective membrane remodelling in a     collection of families with unexplained provoked hemorrhages and evaluation of their     prognosis value in the assessment of the hemostatic cellular response.Hypothesis: Scott     syndrome is rare a familial disorder characterized by provoked haemorrages in homozygous-type     patients due to isolated membrane remodelling deficiency. Membrane remodelling is necessary     for cellular hemostatic responses.   "
211078|NCT00617734|"     The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab     (Erbitux®) can increase survival in patients with Squamous Cell Head and Neck Cancer who have     had disease progression and platinum-containing chemotherapeutic regimen.   "
211080|NCT00617760|"     The purpose of this study in healthy toddlers who have not previously been immunized against     MenC infection and who completed their primary immunization series with PCV-7 (3     vaccinations) during infancy is to demonstrate that the concomitant administration of a     single dose of MenC-TT vaccine and a PCV7 booster does not influence the immune response to     the seven pneumococcal strains contained in PCV7 as compared to administration of PCV7 alone,     and does not influence the immune response to the MenC-TT vaccine as compared to     administration of MenC-TT vaccine alone.   "
211081|NCT00617773|"     RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them.      PURPOSE: This phase II trial is studying how well Hu3S193 works in treating patients with     ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.   "
211082|NCT00617786|"     This is a prospective study. Subjects will be recruited from the urology practices of Dr. Ken     Peters and Dr. Ananias Diokno at William Beaumont Hospital. Subjects will be referred to the     study by the clinician recommending Sacral NeuroModulation therapy (SNM).      This pilot study is to explore the effect of SNM on sensory pathways by measuring CPT values     pre and post SNM treatment.   "
211083|NCT00617799|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at biomarkers that predict response to high-dose     aldesleukin in patients with metastatic kidney cancer or metastatic melanoma.   "
211084|NCT00617812|"     The purpose of this study is to evaluate the safety and immunogenicity of an indigenously     developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib)     combination vaccine in healthy Indian infants as a part of the routine immunization in     accordance with the EPI schedule.   "
211086|NCT00617838|"     Celiac disease is an autoimmune disease induced by wheat gluten. Destruction of epithelial     cells and microvilli on gut mucosa is causing a flat mucosa and an absorption defect. The     diagnosis is based on typical microscopical finding in biopsy specimens but serum antibodies     to tissue transglutaminase and certain gliadin peptides are strongly associated with the     pathology. Severe diarrhoea associated with growth disturbance in infancy was historically     characterising the disease but is nowadays rare. Clinically more mild forms including silent     disease are very common. Studies based on antibody screening and biopsies done in     autoantibody positive subjects have confirmed a frequency of about 1-2% in adult population.     Undiagnosed disease is associated with deficiencies of nutrients and vitamins leading to     various chronic symptoms like anaemia, osteoporosis and general fatigue. It has also been     recently found that undiagnosed celiac disease may be associated with general     underachievement in society probably associated with common psychological symptoms like     fatigue and depression during the adolescence. The disease is treated by complete elimination     of wheat, rye and barley in the diet, which is laborious and causing considerable extra costs     in nutrition.      Much progress has been recently made in understanding of the genetic background and immune     markers associated with the disease as well as in understanding those patterns of gluten     introduction in infancy, which might be connected to a high disease risk. Our aim in this     study is in the first phase to identify children at high genetic risk (around 10%) and in a     follow-up study to define:        1. Are the age, dose of gluten and presence of simultaneous breast feeding at the          introduction of gluten associated with the risk of celiac disease?        2. Is it possible to decrease the frequency of celiac disease by nutritional counselling?        3. Is it possible to predict development of celiac disease by immunological tests before          the development of mucosal lesion      If we can confirm, that optimising the conditions at the introduction of wheat gluten in     infancy diet significantly reduces the disease incidence, will this have an important effect     on the nutritional recommendations concerning the diet in infancy. Combining genetic     screening and immunological tests might also offer a way to reduce the frequency of celiac     disease and help in early diagnosis and organisation of an adequate treatment   "
211087|NCT00617851|"     The purpose of this research is to demonstrate immunologic equivalence of three consecutive     production lots of the subunit influenza vaccine compared to egg-derived inactivated     influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to     show how safe and well tolerated a conventional inactivated subunit influenza vaccine,     licensed in many countries outside the United States, is compared to an inactivated influenza     vaccine, licensed in the United States.   "
211088|NCT00617864|"     This research study was designed to look at the effect of human albumin transfusion on     circulating levels of Vascular Endothelial Derived Growth Factor (VEGF), a protein that is     believed to be responsible for the syndrome of ovarian hyperstimulation. Patients have been     asked to participate because they are identified as at risk for the Ovarian Hyperstimulation     Syndrome (OHSS), a potentially serious complication of in vitro fertilization. It has been     established that the onset of OHSS may be preventable by the infusion of albumin at the time     of egg retrieval; however, we do not know by what mechanism albumin works. As we know the     pathogenesis of OHSS is related to VEGF released from the ovaries, we believe human albumin     may serve to bind up this VEGF and prevent it from causing its harmful effects. The purpose     of this study is to evaluate the effect of albumin infusion on blood and urine VEGF levels in     these patients.   "
211089|NCT00617877|"     The purpose of this study is to evaluate the antihypertensive response of treatment with     losartan with reference to genetic polymorphisms.   "
211090|NCT00617890|"     Participants with relapsed osteosarcoma that can be treated with surgery will be randomized     to robatumumab administered intravenously (IV) at one of two dose levels. These participants     will first receive robatumumab, have surgery performed, and continue to receive treatment     every two weeks until a year of dosing, or until disease progression.      Participants with unresectable osteosarcoma or Ewing Sarcoma will receive robatumumab IV once     every two weeks until disease progression. Participants who achieve a complete response (CR)     or partial response (PR) after tumor evaluations may undergo surgical resection. After     surgery, participants are eligible to receive 10 mg/kg robatumumab until disease     recurrence/progression or one year of total dosing, whichever occurs first.   "
211091|NCT00617903|"     This exploratory study is being performed to determine whether a new form formulation of     azelaic acid 15% is effective in the treatment of papulopustular rosecea.   "
211092|NCT00617916|"     This study is designed to test a prototype imaging instrument that relies on Medical     HyperSpectral Imaging (MHSI) technology for the assessment and prediction of diabetic foot     ulceration and wound healing. The imaging system utilizes the biomarkers of oxyhemoglobin     (oxyHb) and deoxyhemoglobin (deoxyHb), in the upper layers of skin on the foot as: a metric     for assessing wound healing, a reflection of microvascular disease, and determining tissue at     risk for forming new ulcers. MHSI results will also be compare with ABI and TcPO2     measurements.   "
211093|NCT00617929|"     RATIONALE: Antithymocyte globulin, clofarabine, and rituximab may stop the patient's immune     system from rejecting the donor's stem cells when they do not exactly match the patient's     blood. The donated stem cells may replace the patient's immune cells and help destroy any     remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a     donor can also make an immune response against the body's normal cells. Giving antithymocyte     globulin before transplant and cyclosporine and mycophenolate mofetil before and after     transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with     clofarabine and rituximab works in treating patients after an unsuccessful stem cell     transplant.   "
211094|NCT00617942|"     Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable     and unresectable HER2+ (stage IIa-IIIb) breast cancer   "
211095|NCT00617955|"     The dept. of Anesthesiology currently has a database of subjects whom had surgery and     received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is     more harmful than Amicard. In an effort to see what the long term outcomes were for subjects     whom had surgery here at Upstate, it was decided to look at long term death rates to see if     any differences. A student t-test will be used to determine statistical significance where a     p value of <0.05 will be deemed significant. Using data from 462 subjects that had undergone     cardiac surgery at SUNY Upstate Medical University, CABG only and the long term mortality     rate from the Mangano, et.al. publications, the unadjusted mortality for the two drugs are     Aprotinin 5.4% and Amicar 1.2%. A power analysis was performed using the hospital mortality     rates of 5.4% and 1.2% with the sample size in the propensity data and a p-value of 0.05. The     result was a power of 81.7%.   "
211096|NCT00617968|"     Primarily to evaluate the rates of clinical and radiological response in the 2 groups.     Secondarily rate of histological response.   "
211097|NCT00617981|"     The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal     doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when     used in conjunction with radiofrequency ablation (RFA).   "
211101|NCT00618033|"     This study aims to show that using a glucose (sugar) concentration of 100 mg/dL in the     dialysis fluid for hemodialysis is not inferior to using a concentration of 200 mg/dL with     regard to the frequency and magnitude of blood glucose drops. Other parameters that will be     compared between the two groups are blood pressure, heart rhythm, weight gain between     dialysis treatments, and fatigue after the treatment.   "
211102|NCT00618046|"     The objective of this study was to assess bioequivalence of a potential generic 600 mb     oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine     tablet, Trileptal, following a single 600 mg dose, administered with food.   "
211103|NCT00618059|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine     tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fed conditions using a single-dose,     randomized, 2-treatment, 2-period, 2-sequence crossover design.   "
211104|NCT00618072|"     The goal of the study is to identify and treat women with midlife weight gain who have normal     blood sugars, but increased insulin levels (hyperinsulinemia) following the performance of a     glucose tolerance test. The study will evaluate effects of a unique carbohydrate modified     diet alone and in combination with metformin(MF) and Avandamet® (MF plus rosiglitazone (RSG))     on insulin levels in a wide range of ethnically diverse women (aged 35-55) at three academic     medical centers. The primary study hypothesis is that insulin sensitizing medications, in     combination with alterations in carbohydrate intake, will reduce insulin levels and improve     established risk factors for the metabolic syndrome.      The alarming prevalence of obesity, diabetes, and related comorbidities and the paucity of     easily adopted, cost-effective preventive strategies for high risk populations, suggest that     pharmaco-therapies and dietary regimens targeted to reducing insulin resistance could have     important clinical and public health implications.   "
211105|NCT00618085|"     Motor imagery is a technique widely used in learning skills. Its effectiveness has been     proven in various sports and in musicians. A recent review (Braun et al. 2006) suggested that     this technique may also be effective in rehabilitation of patients with neurological disease     or damage, but that further research was needed.      The main purpose of this research is to discover whether motor imagery practice is beneficial     in the rehabilitation of skills in patients who have some disability due to neurological     disease or damage. The principal research question is: are physiotherapy and occupational     therapy given incorporating motor imagery more effective than standard care (i.e., the same     therapies but without integrated motor imagery) in re-training task specific performance for     patients with neurological disease or damage?   "
211106|NCT00618098|"     The purpose of this study is to determine whether Octaplex (human prothrombin complex     concentrate) can reverse the effects of anticoagulants when compared to the standard     treatment of fresh frozen plasma (FFP).   "
211107|NCT00618111|"     The objective of this study was to assess bioequivalence of a potential generic 1 mg     granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet,     Kytril, following a single 1 mg dose, under fed conditions.   "
211108|NCT00618124|"     This study assesses the maximum tolerated dose, overall safety and antitumor activity of     SU011248 in combination with capecitabine in patients with advanced solid tumors   "
211113|NCT00618202|"     The objective of this study was to assess the bioequivalence of a potential generic 750 mg     balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg     balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under     fasting conditions.   "
211114|NCT00618215|"     Background: Routine oral examination (ROE) refers to periodic monitoring of the general and     oral health status of patients. In most developed Western countries a decreasing prevalence     of oral diseases underpins the need for a more individualised approach in assigning recall     intervals for regular attendees instead of systematic decision making of fixed intervals.     From a quality of care perspective as well, one can also question the effectiveness of the     widespread prophylactic removal of mandibular impacted asymptomatic third molars (MIM) in     adolescents and adults. It is as yet unclear how quality of oral care can be improved.     Research data on effectiveness of interventions to promote continuing professional     development for dentists are rare.      Methods/Design: This implementation study is a cluster randomised controlled trial with     groups of GDPs as the unit of randomisation. The aim of the study is to determine the     effectiveness and efficiency of small group quality improvement on professional decision     making of general dental practitioners (GDPs) in daily practice. Six peer groups     ('IQual-groups') shall be randomised either to the intervention group I or group II. Groups     of GDPs allocated to either of these arms act as each other's control group. An IQual peer     group consists of 8-10 GDPs who attend in monthly structured sessions scheduled for     discussion on practice related topics.      GDPs in both trail arms receive recent developed evidence-based CPG on ROE or MIM     respectively. The implementation strategy consists of 1 interactive IQual circle meeting of     mostly 2-3 hours. In addition, both groups of GDPs receive feedback on personal and group     characteristics and are invited to make use of web-based patient vignettes for further     individual training on risk assessment policy. A few weeks after the interactive meeting     reminders (flow charts) will be send by mail.      The main outcome measure for the ROE-study and control group is the use and appropriateness     of individualised risk assessment in assigning recall intervals and for the MIM-study the use     and appropriateness of individualised mandibular impacted third molar risk management.      Measurements (pre-intervention data collection) will take place in months 1-3, starting in     September 2006. Post-intervention data collection will be performed after 9 months.      Discussion: In most developed Western countries a decreasing prevalence of oral diseases     underpins the need for a more individualised approach in assigning recall intervals for     regular attendees. If the evaluation of this multifaceted implementation study reveals a     shift in individual performance of GDPs in assessing risks for oral disease, further research     questions and efforts to a risk-based professional education could be promoted.      Scientific hypothesis Multifaceted implementation of consensus based clinical practice     guidelines (CPGs) for GDPs on ROEs and the management of asymptomatic impacted third molars     (MIM) in daily dental practice is more effective and efficient compared to only dissemination     of CPGs.   "
211115|NCT00618228|"     The objective of this study was to assess bioequivalence of a potential generic 750 mg     balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg     balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting     conditions.   "
211116|NCT00618241|"     The purpose of this study is to determine whether interactions between raltegravir and     lamotrigine take place and to study the safety of the combination raltegravir/lamotrigine     before used in HIV patients.   "
211117|NCT00618254|"     The objective of this study was to assess bioequivalence of a potential generic 1 mg     granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet,     Kytril, following a single 1 mg dose, under fasting conditions.   "
211150|NCT00618696|"     RATIONALE: Monoclonal antibodies can block cancer growth in different ways. Some block the     ability of cancer cells to grow and spread. Radioactive monoclonal antibodies, such as     yttrium Y 90 monoclonal antibody, can find cancer cells and either kill them or carry     cancer-killing substances to them without harming normal cells.      PURPOSE: This phase I trial is studying the side effects and best dose of a yttrium Y 90     monoclonal antibody and how much radiation is taken in by the organs in the body in treating     patients with advanced leukemia or other hematologic disorder.   "
211118|NCT00618267|"     The purpose of this study is to see if we can find a new way to test how certain Multiple     Sclerosis (MS) medications work in the body and to better understand how the medicines change     certain substances (cells) found in the immune (protective) system.      Blood test will be drawn by doing the following:        -  Use a new method called the Immuknow® Test to see if this method will help to better          understand how MS medicines work.        -  Measure certain levels of immune cells in a new way, to see if it this will help to          understand the body's response to MS medicines.      These methods will test those with MS who are not taking any MS medications, to help us     compare the results.      About 100 subjects will be enrolled in this study at the Partners Multiple Sclerosis Center     at Brigham and Women's Hospital. Biogen Idec, Inc. of Cambridge, MA, is paying for this study     to be done.   "
211119|NCT00618280|"     In the present study, we investigate healthy subjects and schizophrenic patients who     frequently show very low attentional capacity with functional magnetic resonance imaging     (fMRI) and electrophysiology (EEG) during attention-requiring tasks to assess the level of     attentional network activity.   "
211120|NCT00618293|"     Evaluation of efficacy by determination of transfusion requirements and safety by     determination of adverse events in administration of Von Willebrand factor concentrate F VIII     (Haemate).   "
211121|NCT00618319|"     This study will examine the effect of BIIB021 on GIST growth and metabolism.   "
211122|NCT00618332|"     We hypothesize that those patients with purely seasonal allergic rhinitis will decongest     better than those subjects with another cause contributing to their symptoms. These latter     patients will not improve as well on an intranasal steroid as those who decongest well,     potentially explaining the 60% response rate in prior studies.   "
211123|NCT00618345|"     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the cancer.      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with     relapsed or refractory multiple myeloma.   "
211124|NCT00618358|"     Study Objective:To evaluate the safety and effectiveness of the Vascular Sealant compared     with Gelfoam/Thrombin when used to seal bleeding anastomotic suture lines in patients     undergoing vascular reconstructive surgery requiring placement of a PTFE graft (including     extra-anatomic, infrainguinal bypass and arteriovenous (AV) access procedures).      Study Design: The study is a multi-center, prospective, randomized controlled clinical trial     that will compare two methods for treating anastomotic leakage (bleeding). All subjects (n     =151) will be randomized at a 3:1 ratio to receive either the investigational treatment     (Vascular Sealant) or the control treatment (Gelfoam/Thrombin). Up to two (2) treatment sites     may be evaluated for each subject. Subjects will be stratified by type of graft procedure: AV     access graft or extra-anatomic and infra-inguinal graft. A minimum of 60 patients, and a     maximum of 91 patients, will be enrolled in each stratum. Treatment randomization will be     blocked by center and type of graft procedure (e.g., bypass or AV grafts). All subjects will     undergo preoperative screening to determine eligibility and will be evaluated     intraoperatively, at discharge or within 7 days of surgery, and 30 days post-procedure to     monitor for hematologic disturbances, hemorrhagic events, wound complications and other     potential acute post-operative adverse events.      Up to ten (10) investigational sites will participate in the study. Enrollment is expected to     take approximately 8 months for an anticipated duration of the clinical investigation of     approximately 9 to 10 months.      The primary objective of this trial is to demonstrate non-inferiority of the Vascular Sealant     to Gelfoam/Thrombin when used to seal anastomotic suture lines in patients undergoing     placement of PTFE vascular grafts (including extra-anatomic, infrainguinal bypass and     arteriovenous access procedures).   "
211125|NCT00618371|"     The medicines used to treat HIV can suppress but cannot kill all the virus in the body. A     small amount of virus remains at low levels in the part of the blood called the plasma. It is     of crucial importance to identify the source of the residual virus in patients receiving     antiretroviral therapy. The purpose of this study is to investigate whether the source of low     level plasma virus is from latent (old) infection or ongoing (new) infection. MK-0518 is a     investigational drug, which means that is not yet FDA approved, that works in a different way     to other anti-HIV medicines to help kill the virus. We hypothesize that addition of MK-0518     to a stable anti-HIV regimen will reduce the viral load further in patients with undetectable     plasma virus.   "
211126|NCT00618384|"     For patients with advanced HCC not suitable for resection or liver transplantation but     without extrahepatic manifestations, local therapy with TACE is regarded as standard     treatment. The present study is planned to evaluate the combination of TACE and sorafenib. A     combination of TACE with a multitarget inhibitor like sorafenib may further improve the     outcome of patients with HCC.   "
211127|NCT00618397|"     Opioids, such as fentanyl, are commonly used in PICU patients to provide comfort and pain     control. Opioid tolerance, the need to increase the dose of medication to achieve the same     effect,is seen in PICU children who require opioid infusions. Animals and human studies have     shown that activation of the N-methyl-D-aspartate (NMDA) receptor is involved in the     development of opioid tolerance and that deactivation of this receptor can slow the     development of tolerance. Ketamine, an NMDA receptor antagonists, turns off the NMDA     receptor. Ketamine is used to provide sedation and anesthesia in children. Its use in     inhibiting the development of opioid tolerance has not been tested in children. We aim to     determine ketamine's effectiveness in the treatment of tolerance in PICU patients who require     fentanyl infusions to treat pain and discomfort .      Some physicians have reported using ketamine doses of 0.04mg/kg/hr to 0.5mg/kg/hr to inhibit     opioid tolerance. We propose to study the sedative effect, and the metabolism of, three doses     of ketamine, 0.1mg/kg/hr, 0.3mg/kg/hr, and 0.5mg/kg/hr.      Patients admitted to the PICU, requiring a breathing machine and fentanyl infusion for     discomfort or pain control will be enrolled. Patients' age three to eighteen years will be     enrolled. Patients will receive a ketamine infusion once their COMFORT scores indicate an     adequate sedation/comfort level on their current sedation regimen. The COMFORT score is a     validated scale that measures distress in PICU patients. The COMFORT score will be continued     for the twelve hours the patient receives the ketamine to test whether the ketamine adds to     the level of sedation. Blood samples during and following the ketamine infusion will be taken     to determine how ketamine and norketamine (one of ketamine's metabolites) are used in the     body.      To determine the effect of ketamine on tolerance it must be a ketamine dose that does not     cause additional sedation. The goal of this study is to define a non-sedating dose of     ketamine and define how it is used by the body. A non-sedating ketamine dose could be added     to current sedation regimens allowing us to monitor the development of tolerance without the     confusion of added sedation. The data obtained in this study will be used to design a study     to further investigate the effect of ketamine on opioid tolerance.   "
211128|NCT00618410|"     The purpose of this study is to better understand the way in which CO2 (carbon dioxide)     affects the symptoms of allergic rhinitis or hayfever.      Our intent is to determine if CO2 has an effect on nasal challenge with antigen as a     predictor of whether it will have a beneficial effect on the treatment of seasonal allergic     rhinitis.   "
211147|NCT00618657|"     This phase II is studying the side effects and how well carboplatin and paclitaxel     albumin-stabilized nanoparticle formulation when together with bevacizumab or trastuzumab     before surgery works in treating patients with stage I-III breast cancer. Drugs used in     chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as bevacizumab and trastuzumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Giving more than one drug (combination chemotherapy) and monoclonal antibody therapy together     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs     to be removed.   "
211129|NCT00618423|"     After a surgical operation, patients may suffer from chronic pain. Ketamine, a well known     anesthetic acts on receptors in the spine (NMDA receptors), which are implied in the     occurrence of chronic pain. The mechanism is called central sensation. It is known that     Ketamine reduces immediate postoperative pain, but its effectiveness in the prevention of the     chronic pain is still unknown. The investigators study will follow patients until one year     after operation for the occurrence of chronic pain. The investigators hypothesis is that     Ketamine reduces significantly chronic postoperative pain after major back surgery and     improves patient outcome.      There may be important inter-individual differences how persons react on a drug. These     differences are partly determined by the genes of each individual. The investigators study     includes therefore a genetic analysis.      Psychological and social factors also influence the perception of pain. It is still not well     understood who these psychosocial factors determine the appearance and perception of     chronic pain. In the investigators study the investigators will therefore study these factors     by questionnaires.   "
211130|NCT00618436|"     To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prevention in     patients in the Neuroscience Intensive Care Unit will result in fewer side effects compared     to the current standard of care anticonvulsant and will be at least as effective as the     current standard of care in preventing clinical and sub-clinical seizure activity.   "
211131|NCT00618449|"     Trachoma is a disease of poverty, which in the hyperendemic areas affects all individuals by     the time they are two years old. Active disease is concentrated in children and occurs     sporadically in adults. Infection is more widespread. It is anticipated that 25% of the     children will be blinded by this disease if they live to be 60 years of age. The blindness     rates are higher in women, presumably because of their closer contact with children who can     infect them and add to damage from infections the women had while young.      This proposal is to better define how azithromycin in community-based treatment can be used     to eliminate blinding trachoma. We will also take the opportunity to join these field studies     with genetic epidemiologic studies to better understand the dynamic epidemiology of Chlamydia     trachomatis infection in a trachoma endemic area. The empiric data generated from the     treatment/follow-up studies, together with the information on sources and spread patterns     from genetic epidemiology will be used to generate more robust models to guide future     treatment/re-treatment protocols.      We propose to conduct a randomized, community based trial in the Maradi region of Niger to     test the hypothesis that two community wide azithromycin treatments, spaced one month apart,     are significantly more effective in reducing ocular C. trachomatis infection and trachoma at     one year compared to a single mass azithromycin treatment.   "
211132|NCT00618462|"     This study will determine the effectiveness of three different treatment strategies in     reducing gambling behaviors in pathological gamblers.   "
211133|NCT00618475|"     Depression is second in frequency only to hypertension as a comorbid condition for End Stage     Renal Disease (ESRD) patients. The presence of depression has been linked to lower quality of     life, more medical comorbidities and shorter lifespan. This project represents the first     known attempt at a standardized intervention for depression in ethnically diverse ESRD     patients. The study will be conducted at the Parkside Center for Dialysis. Patients will be     randomly selected for screening until 80 subjects meet entry criteria and agree to be     randomized. Once subjects are screened and enrolled in the study they are randomly assigned     to either a treatment or wait-list control condition. After 3 months, the intervention will     be completed and both groups will be reassessed. After an additional 3 months, both groups     will have received the intervention and pre and post measures for both groups will be     available as well as 3 month follow-up for the 1st intervention group.      The following measures will be collected: to obtain a full DSM-IV diagnosis the SCID I and     SCID II will be utilized. The BDI will provide a self-report measure of depression. The     Hospital Anxiety and Depression Scale (HADS), a measure designed specifically for medically     ill patients, will also be administered. Additionally, the Young Schema Questionnaire, a     measure which seeks to identify maladaptive (both depressive and anxious) cognitive styles,     will be administered. A quality of life measure designed specifically for dialysis patients     (KDQOL-SF) will also be given as a means of measuring patient's overall coping and     functioning. To better understand the patient's perceptions of their health and illness the     Illness Effects Questionnaire will be administered. A demographic information sheet will be     completed by the subject in which personal, ethnic, and illness information is collected.     Detailed information about the subject's mental health history and treatment as well as     current medications will be gathered. Data from routine dialysis laboratories (hemoglobin,     creatinine, albumin, Kt/V) will be extracted from the chart.      The intervention will take place in individual format while the subjects are being dialyzed.     The intervention will be 10 sixty minute -long weekly sessions spread over not more than 3     months. It will include both cognitive and behavioral skills focused on alleviating     depressive affect and identifying maladaptive patterns of thought and behavior. This study     would lay the groundwork for future clinical research by helping to develop a culturally     competent clinical intervention and demonstrate the feasibility and effectiveness of adapting     psychosocial intervention for a medically complex culturally diverse population.   "
211134|NCT00618488|"     The purpose of this study is to determine if probiotics bacteria, specifically     bifidobacterium lactis (BB12) improve gastrointestinal symptoms in subjects with functional     gastrointestinal symptoms (i.e., non-patients IBS/functional bowel disorders).   "
211135|NCT00618501|"     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem     cells. Imatinib mesylate may also stop the growth of cancer cells by blocking the enzymes     necessary for cancer cell growth. When the healthy stem cells from a donor are infused into     the patient they may help the patient's bone marrow make stem cells, red blood cells, white     blood cells, and platelets. It is not yet known which treatment regimen is most effective in     treating acute lymphoblastic leukemia.      PURPOSE: This phase II trial is studying the side effects of giving imatinib mesylate     together with combination chemotherapy with or without a donor stem cell transplant and to     see how well it works in treating patients with newly diagnosed acute lymphoblastic leukemia.   "
211136|NCT00618514|"     This trial was designed as a prospective, multi-center, randomized clinical trial of the     FDA-cleared Vari-Lase Bright Tip Fiber compared to commercially available standard bare-tip     laser fiber (control) to demonstrate the safety and effectiveness of laser ablation for the     treatment of varicose veins associated with reflux within the great saphenous vein (GSV) and     to provide additional data concerning patient satisfaction. Within this evaluation, subject     limbs were randomized to one of two (2) treatment groups utilizing a 1:1 randomization ratio.     If a subject required treatment of only one limb, that limb was randomized to a treatment     group. If a subject required treatment of two limbs, the first limb was randomly assigned     treatment and the second limb was assigned the other treatment (the opposite treatment of the     other limb). The data was analyzed by treated limb (versus treated subject).All study data     were analyzed under the principles of intent-to-treat, in which data are analyzed according     to the assigned randomized group regardless of the treatment actually delivered. Subjects     were followed at one week, one month, and six months.   "
211137|NCT00618527|"     The purpose of this trial is to examine the benefits of early combination of CellCept® with     Rebif® in long-term management of patients with multiple sclerosis. Quantitation of mRNA for     MxA gene from ex-vivo lymphocytes obtained from patients receiving both drugs or interferon     alone will be used to gauge the usefulness of this combination therapy. In addition we will     examine the safety of combination of mycophenolate mofetil and interferon beta 1a in     treatment of multiple sclerosis.      This is a pilot study to examine if the combination of CellCept® with Rebif® will prove to be     useful in the early treatment of patients with MS. Up-regulation of the MxA gene following     the administration of Rebif® will be used as a surrogate marker of interferon bioactivity.     This in turn could serve as a surrogate marker of interferon efficacy in these patients.      The null hypothesis is that there will not be any difference in the proportion of patients     that produce MxA gene transcripts in the Rebif® group as compared to the group that received     Rebif® with CellCept® at the end of this study (1 year).      The alternate hypothesis is that the combination of CellCept® with Rebif® will prove to be     useful in prolonging the efficacy of interferon. In other words, the combination will result     in a significant proportion of patients in the treatment group continuing to produce MxA as     compared to the proportion of patients producing MxA in the Rebif® arm.   "
211138|NCT00618540|"     RATIONALE: Giving a monoclonal antibody, such as alemtuzumab, and chemotherapy drugs, such as     fludarabine and melphalan, before a donor stem cell transplant helps stop the patient's     immune system from rejecting the donor's stem cells and helps stop the growth of abnormal     cells. When the healthy stem cells from a donor are infused into the patient they may help     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Sometimes the transplanted cells from a donor can make an immune response against the body's     normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may     stop this from happening.      PURPOSE: This phase II trial is studying how well giving alemtuzumab together with     fludarabine and melphalan followed by a donor stem cell transplant works in treating young     patients with resistant Langerhans cell histiocytosis.   "
211139|NCT00618553|"     The goal of this clinical research study is to see if pulmonary rehabilitation can improve     patients' lung function, which would increase their chances of becoming eligible for surgery.     The health of pulmonary rehabilitation participants after surgery will also be examined.   "
211140|NCT00618566|"     More women with disabilities (30%) report feelings such as sadness, unhappiness, or     depression that prevent them from being active compared to women without disabilities (8%).     The contexts of the lives of WPD, which often include high rates of poverty, architectural     and attitudinal barriers, and higher vulnerability to violence and abuse, contribute to this     mental health disparity. To help address this disparity, the overall goals of this pilot     study are to: 1)1. Develop a cognitive behavioral group therapy intervention to address the     specific needs of WPD who experience depressive symptoms; and 2. Pilot-test the intervention     to preliminarily evaluate its efficacy using a mixed-methods approach. The proposed and     revised study outcomes were derived from our previous work with WPD as well as from feedback     obtained from community meetings conducted since our last submission of this proposal. A     pilot of the modified intervention with a total of 90 participants will be conducted using a     using a wait list control design. The decision to use a wait list control design was made     jointly with our community partners to ensure that all WPD participating in the study have     access to the intervention.   "
211141|NCT00618579|"     Administration of LMWH in healthy male subjects treated with TB-402 and administration of     TB-402 in healthy male subjects treated with warfarin   "
211142|NCT00618592|"     The recent development of an oral carbohydrate drink for consumption prior to elective     surgical procedures has been shown to improve insulin sensitivity. However, these studies     have not investigated the use of this carbohydrate supplement in patients undergoing cardiac     and spinal surgery.      Hypothesis: The administration of 100g of carbohydrates the evening before and 50g of     carbohydrates two hours before elective coronary artery bypass graft (CABG) or spinal surgery     will reduce postoperative insulin resistance by 40% compared to those undergoing the standard     of care of fasting the evening before and the day of surgery.   "
211143|NCT00618605|"     Successful control of the HIV epidemic will require a safe and effective vaccine to be     developed. A successful vaccine will need to stimulate a widespread immune response. The     purpose of this study is to determine the safety of and immune response to an adenovirus     serotype HIV vaccine in HIV uninfected adults.   "
211166|NCT00607178|"     Influenza vaccine reduces the cardiovascular events in post-myocardial infarction (MI)     patients and in those with stable angina (SA).   "
211145|NCT00618631|"     Background:        -  Tobacco smoking is one of the most preventable causes of morbidity and mortality in the          world, but the addictive property of nicotine is such that fewer than 10 percent of          people who attempt to quit smoking remain tobacco-free after 1 year. Researchers are          studying the addictive properties of nicotine in an attempt to develop more successful          medication therapies for smoking cessation.        -  Nicotine acts on chemical receptors in the brain, including opioid receptors that affect          the perception of pain. Repeated nicotine administration can cause adaptations in the          brain s opioid receptors, which heightens the addictive properties of nicotine and          increases the likelihood and severity of withdrawal symptoms associated with smoking          cessation. Researchers are interested in using positron emission tomography (PET)          scanning to study brain chemical responses to nicotine in current smokers and          nonsmokers.      Objectives:        -  To study brain chemical activity related to cigarette smoking and nicotine          administration.        -  To compare the brain chemical activity of current daily smokers with that of nonsmokers.      Eligibility:      - Individuals 21 to 50 years of age who are either current smokers (10 to 25 cigarettes daily     for at least 2 years) or have had some exposure to tobacco but have never smoked regularly     (may have had a maximum of 20 cigarettes in their lifetime and none in past year).      Design:        -  Eligible participants will undergo initial medical and psychological screening and          neuropsychological testing before beginning the main phase of the study. Participants          will be required to abstain from alcohol and drugs (except caffeine, nicotine, and          prescription drugs) for 24 hours before each session, and smokers will refrain from          smoking after midnight on the night before each session.        -  Session 1: Participants will answer questions about nicotine craving and withdrawal          symptoms, followed by a magnetic resonance imaging (MRI) scan to provide baseline          information about brain activity.        -  Session 2 and 3: Participants will answer questions about nicotine craving and          withdrawal symptoms, and then will smoke one cigarette (either active nicotine or          placebo). Researchers will document participants consumption of the cigarette. After the          cigarette is smoked, participants will have a PET scan. Blood samples will be drawn          during the PET session.   "
211146|NCT00618644|"     The purpose of this study is to determine the ocular and non-ocular safety of a single dose     of ranibizumab in treating neovascularization secondary to sickle cell retinopathy.   "
211148|NCT00618670|"     The purpose of this study is to examine the effects of a home-based exercise rehabilitation     program compared to a supervised exercise program on intermittent claudication (leg pain or     discomfort) and ambulatory function.   "
211151|NCT00618709|"     The purpose of this research is to evaluate the safety and pharmacokinetic profile of single     doses of ATX-101   "
211155|NCT00618761|"     The purpose of this study is to compare functional beta-cell mass using the hyperglycaemic     clamp test in insulin-independent pancreas-kidney recipients with that in non-diabetic kidney     recipients and normal controls as well as with the partially previously reported data in     beta-cell recipients.   "
211156|NCT00618774|"     To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients     with essential hypertension who failed to control their BP with either monotherapy   "
211157|NCT00618787|"     This is a multi-center, prospective, randomized, double blind, pilot clinical trial of     subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA     AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic     wounds.   "
211158|NCT00618800|"     The objective of the proposed study is to reduce the incidence of falls and fall-related     injuries among community-dwelling older adults by better utilizing community pharmacists to     advise patients and physicians on medication management.   "
211159|NCT00618813|"     This clinical trial is studying the side effects of combination chemotherapy and to see how     well they work in treating patients with newly diagnosed localized Ewing sarcoma family of     tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) and giving the drugs in different ways may kill more tumor cells.   "
211160|NCT00618826|"     The purpose of this study is to look at a new chemotherapy schedule in metastatic breast     cancer.   "
211161|NCT00618839|"     This pilot Phase I/II clinical study will be conducted at up to three clinical sites.      This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients,     each with skin defects. The patients are intended to undergo sequential surgical procedures     involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at     various separate or contiguous wound sites. Patients will be randomized within each wound     site to one of two test products: cadaver skin or StrataGraft™ skin tissue.   "
211162|NCT00618852|"     The purpose of this study is to investigate the effects of intravenous furosemide on     cardio-respiratory performance in neonates receiving a packed red blood cell (PRBC)     transfusion who are considered at high risk of volume overload.   "
211163|NCT00618865|"     Whether high-dose omega-3 fatty acids supplement would be an effective treatment in patients     with major depressive disorder during pregnancy and breast-feeding.   "
211168|NCT00607204|"     Sleep is necessary for healthy functioning, and people who sleep too little or too much may     have an increased risk of developing health problems. This study will examine people who     regularly sleep for short or long amounts of time to understand the biological factors that     determine how much sleep a person needs.   "
211169|NCT00607217|"     This study wishes to understand:        1. whether vaccination against influenza in coronary artery disease (myocardial infarction          and stable angina) patients is as effective as it is in healthy subjects;        2. whether vaccination really decreases the episodes of influenza infection in those          coronary artery disease patients who receive the vaccine than those who do not.   "
211170|NCT00607230|"     Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the     pancreas. The investigators have discovered the specific autoimmune cells responsible for     destroying the insulin-producing cells in an animal model of type 1 diabetes, and the means     of destroying those cells.   "
211171|NCT00607243|"     The currently available stock of smallpox vaccine would be insufficient in the face of an     incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are     urgently needed because previous manufacturing methods using calf lymph are no longer     acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea     has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by     infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity,     and immunogenicity of CJ-50300.   "
211172|NCT00607256|"     To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with     fibromyalgia   "
211173|NCT00607269|"     This study evaluates a contingency management program that rewards homeless,     non-treatment-seeking substance abusing men who have sex with men (MSM) for abstaining from     drugs and for performing prosocial behaviors. If this program motivates these individuals to     increase prosocial and healthy behaviors and decrease drug/alcohol use, established     prevention programs may modify their approaches to include contingency management, and use it     to address the staggering public health problems homeless substance-abusing MSMs face on a     daily basis.   "
211174|NCT00607282|"     The purpose of this study is to evaluate the efficacy of Udenafil (Zydena®, Dong-A     Pharmaceutical co., Ltd, Seoul, Korea) in treatment of erectile dysfunction after radical     resection for sigmoid colon and rectal cancer. In this study, the efficacy of Udenafil will     be evaluated in treatment for patient with chronic erectile dysfunction, which developed     after radical resection for sigmoid and rectal cancer and continues 12 months after the     surgery.   "
211175|NCT00607295|"     1. Although after treatment for breast cancer such as chemotherapy or hormonal therapy,          urogenital atrophy is common, the patients are seldomly treated for several reasons.          Management of this problem is important for improving quality of life.        2. Clino-san is a kind of vaginal lubricant with pH 5 which is similar pH of          premenopausal vaginal discharge. After randomization of patients, they are treated with          Clino-san or placebo 3 times/week for 12 weeks.        3. We check the vaginal symptoms, vag dryness severity score, and ultrasonography at          baseline, 4, 8, and 12 weeks of treatment.   "
211176|NCT00607308|"     The purpose of this study is to examine the safety, tolerability, pharmacokinetics,     pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects     with mild to moderate Alzheimer's Disease.   "
211177|NCT00607321|"     To assess the feasibility and safety of the Medtronic Bifurcation Stent System for the     treatment of single de novo bifurcation lesions in native coronary arteries with reference     vessel diameters (RVD) for the proximal main vessel of 3.8 - 4.3 mm, distal main branch of     3.0 - 3.5 mm, and side branch RVD up to 2.5 mm.   "
211622|NCT00607841|"     Phase I is a dose-escalation study designed to assess safety and tolerability in patients     with metastatic breast cancer. Phase II will measure response rate in patients with     metastatic breast cancer.   "
211178|NCT00607334|"     The purpose of this study is to compare the performances of normally developing children and     children with Language Impairment (LI) in three different experimental settings designed to     promote vocabulary acquisition. This comparison will also provide evidence to support     different intervention approaches designed to increase vocabulary abilities, which has been     proved to be one of the major deficits of young children with LI.   "
211179|NCT00607347|"     The researchers hypothesize that the impact of increasing systemic exposure to atenolol leads     to increased risk for adverse metabolic effects from atenolol therapy in hypertension. This     will be accomplished through a 24-hour pharmacokinetic (PK) study and oral glucose tolerance     test in hypertensive patients taking chronic atenolol 100 mg daily.   "
211180|NCT00607360|"     Drug Courts were developed as a therapeutic alternative to incarceration of drug-involved     offenders by providing 'judicially supervised' drug abuse treatment and probation for     nonviolent offenders in lieu of criminal prosecution and incarceration. Outcome studies have     shown that drug courts have modest effects on participation in drug abuse treatment, drug     use, and employment. The Therapeutic Workplace intervention is an effective employment-based     treatment that integrates abstinence reinforcement contingencies in a work setting, intended     to treat individuals with histories of drug addiction and chronic unemployment. Under this     intervention, drug abuse patients are hired and paid to work. To promote abstinence, patients     are required to provide drug-free urine samples to gain and maintain daily access in the     workplace. In this way, patients can work and earn salary, but only as long as they remain     drug abstinent. Patients using drugs and lacking job skills participate in an initial     training phase to initiate abstinence and establish computer data entry skills. Once     abstinent and skilled, patients are hired into an income-producing Therapeutic Workplace data     entry business. Given that many drug court participants suffer from long histories of drug     addiction and unemployment, the Therapeutic Workplace could be ideal for this population.     This proposes of this clinical trial is to evaluate the Therapeutic Workplace intervention in     a Drug Court.   "
211181|NCT00607373|"     The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012)     in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy.      This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up     period. Following treatment and Week 28 evaluations, participants could elect to enroll in an     open-label extension study (301012-CS6; NCT00694109). Participants who were not eligible or     elected not to enroll in the open-label extension study or who discontinued during the     28-week treatment period were followed in this study for 24 weeks from administration of the     last dose of study drug.   "
211183|NCT00607399|"     SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity     may be important in growth and survival of some types of cancer. This Phase I trial is     studying the safety, side effects, and best dose of SGX523 when given to patients with     advanced cancer, and how well it inhibits MET activity in tumors.   "
211184|NCT00607412|"     The goal of this study is to evaluate a psychotherapy for PTSD and substance use disorders     among women who have experienced domestic violence. The hypothesis is that women who receive     present-focused, integrated treatment will have greater PTSD symptom reduction and have less     substance use after treatment than women in the control condition who will receive supportive     therapy based on a 12-step approach.   "
211185|NCT00607425|"     This is a pilot study to test the feasibility of using gene expression from saliva to     identify patients with early-stage non-small cell lung cancer (NSCLC).      The primary objective of this study is to compare gene expression profiles from saliva from     healthy controls and patients with early-stage non-small cell lung cancer.      To be eligible, patients with non-small cell lung cancer, must not yet have received     treatment for their cancer (surgical removal, chemotherapy, or radiation therapy). Health     control participants may participate if they meet eligibility criteria listed below.      Eligible enrollees will be asked to submit a one time saliva sample and complete a study     questionaire.   "
211186|NCT00607438|"     This is a Phase II, open-label, non-randomized study in patients with locally advanced or     metastatic breast cancer.      Each cycle will be 4 weeks in length. Patients will receive Abraxane weekly for 3 weeks.     Patients will not receive Abraxane during week 4 (rest week). Nexavar will be given     continuously.      Patients will be radiologically evaluated every 8 weeks for response. Patients will continue     to receive study treatment until disease progression or unacceptable toxicity.   "
211187|NCT00607451|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetic and     pharmacodynamic effects of single doses of Neu-120 in Parkinson's disease patients with     levodopa-induced dyskinesia.   "
211188|NCT00607464|"     Does polyethylene occlusive wrap applied immediately after delivery to infants born at less     than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the     standard of care as determined by the Neonatal Resuscitation Program guidelines (i.e. drying     under radiant heat)?   "
211189|NCT00607477|"     The purpose of this study is to describe the length of time and extent of blood pressure     response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular     endothelial growth factor (VEGF) inhibitor treatment induced hypertension.   "
211190|NCT00607490|"     This study will evaluate the relative effectiveness of cognitive-behavioral therapy and     supportive psychotherapy for the treatment of women with vulvodynia.   "
211191|NCT00607503|"     The purpose of the study is to gain experience with the use of terbutaline in children with     T1D and to determine that there is not a frequent serious, unexpected, uncontrollable effect     on short-term glycemic control. Some information also will be obtained with regard to whether     terbutaline, in the dosing being used in the study, is sufficiently well tolerated to expect     that adherence will be satisfactory in a large randomized trial. In addition, this pilot     study will provide data on the accuracy of a continuous glucose monitor during terbutaline     use to verify that the drug does not impact on sensor function.   "
211192|NCT00607516|"     Substudy and continuation of HEMI-SAB-UUS (NCT00491673)      Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and     measurements of periprosthetic bone mineral density in cemented and uncemented     hemiarthroplasties in patients with femoral neck fractures.      Null hypothesis: No difference in acetabular wear or in bone mineral density changes between     cemented and uncemented hemiarthroplasties   "
211193|NCT00607529|"     This study is being done to see if the Nova Creatinine Meter can give a correct measure of     creatinine (a blood test used to measure kidney function) when the blood is taken from a     capillary (smallest type of blood vessels). The Nova Creatinine Meter is a hand held device     that can be used in a clinic to measure creatinine in about 50 seconds. Current laboratory     creatinine testing can take up to an hour. Since chemotherapy patients need to have their     creatinine measured prior to treatment, this meter could make testing easier and faster.   "
211194|NCT00607542|"     Oral baclofen is used commonly to treat spasticity in children with cerebral palsy. Although     for adults there is dosing,safety and efficacy information in the package insert, this is not     the case for children. The purpose of this study is to determine how fast the drug is cleared     from the body, the correct dose, and long-term safety and efficacy for children with     spasticity.   "
211195|NCT00607555|"     In this study, we want to see how feeding affects breathing in small premature babies. Using     a special feeding tube in the stomach, we can measure how the diaphragm (a large breathing     muscle) might be affected by feeding. We also want to see if slowing down the feeding may     lessen this effect.   "
211196|NCT00607568|"     A total of 18 healthy volunteers will participate in this four-week, within-groups,     double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day     washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or     placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After     receiving medication or placebo for three days, subjects will have a 6-hour laboratory     session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg     maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and     subjective outcome measures will be obtained during the experimental sessions. Subjects will     then have a 4-15 day washout period and will be crossed over to the alternative treatment for     Phase II.   "
211197|NCT00607581|"     The treatment of light-chain (AL) amyloidosis is directed against the plasma cells that     produce the light-chain forming the amyloid deposits. The plasma cells can be killed and     their growth can be stopped by drugs used in chemotherapy, such as cyclophosphamide,     steroids, such as dexamethasone, and drugs that stimulate the immune system, such as     lenalidomide.      The present trial studies the efficacy and safety of the combination of cyclophosphamide,     lenalidomide and dexamethasone in patients with AL amyloidosis who were previously treated     and need further therapy.   "
211198|NCT00607594|"     This phase II trial is studying how well saracatinib works in treating patients with locally     advanced or metastatic stomach or gastroesophageal junction cancer. Saracatinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
211199|NCT00607607|"     Patients will be treated with MKC-1, twice daily for 14 consecutive days every four weeks (a     cycle of MKC-1 chemotherapy), until disease progression or unacceptable toxicities. Patients     will be stratified to Arm A (ovarian cancer) or Arm B (endometrial cancer), and will receive     identical treatment regimens.   "
211200|NCT00607620|"     The goal of the Disseminating Organizational Screening and Brief Interventions Services     (DO-SBIS) investigation is to capitalize on the unique opportunity afforded by the American     College of Surgeons' mandate by taking early steps to insure high quality, evidence-based SBI     services are implemented and outcomes are assessed. In the first phase of the investigation,     SBI services will be assessed for all 190 level I trauma centers in the United States. In the     second phase of the investigation, 20 level I trauma centers will be selected for     randomization to intervention or control conditions.   "
211201|NCT00607633|"     The CandLE study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg     candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions,     i.e. under routine medical care conditions, the impact of the antihypertensive therapy with     candesartan or candesartan/HCT on relevant medical parameters related to the left ventricular     hypertrophy (LVH) as well as the efficacy and tolerability of candesartan or candesartan/HCT     in subjects suffering from essential hypertension..   "
211202|NCT00607646|"     Elevations of plasma cortisol, a stress hormone, during prior episodes of low blood sugar     (hypoglycemia) appear to be responsible for the deficient responses during subsequent     hypoglycemia. Our specific aim is to determine if dehydroepiandrosterone (DHEA), a hormone     with anti-corticosteroid actions, can prevent hypoglycemia associated autonomic failure in     type 1 diabetic volunteers.   "
211203|NCT00607659|"     Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern     due to their prevalence and potentially devastating reproductive consequences, including     pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to     evaluate the risk factors for adverse outcomes following genital tract infection with     Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the     rectum act as a reservoir for infection.   "
211204|NCT00607672|"     Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary     bypass (CPB).1 CPB is associated with significant morbidity including hemodynamic     instability, the transfusion of allogenic blood products, and inflammation. Blood product     transfusion increases mortality after cardiac surgery. Enhanced fibrinolysis contributes to     increased blood product transfusion requirements in the perioperative period. CPB activates     the kallikrein-kinin system (KKS), leading to increased bradykinin concentrations.     Bradykinin, acting through its B2 receptor, stimulates the release of nitric oxide,     inflammatory cytokines and tissue-type plasminogen activator (t-PA). Based on data indicating     that angiotensin-converting enzyme (ACE) inhibitors reduce mortality in patients with     coronary artery disease, many patients undergoing CPB are taking ACE inhibitors. While     interruption of the renin-angiotensin system (RAS) reduces inflammation in response to CPB,     ACE inhibitors also potentiate the effects of bradykinin and may augment B2-mediated change     in fibrinolytic balance and inflammation. In contrast, angiotensin II type 1 receptor     antagonism does not potentiate bradykinin and does not inhibit bradykinin metabolism.      Studies in animals suggest that bradykinin receptor antagonism inhibits reperfusion-induced     increases in vascular permeability and neutrophil recruitment.A randomized, placebo     controlled clinical trial of a bradykinin B2 receptor antagonist demonstrated some effect on     survival in patients with systemic inflammatory response syndrome and gram-negative sepsis.     In addition, we and others have shown bradykinin B2 receptor antagonism reduces vascular t-PA     release during ACE inhibition. The current proposal derives from data from our laboratory and     others elucidating the role of the KKS in the inflammatory, hypotensive and fibrinolytic     response to CPB. Specifically, we have found that CPB activates the KKS and that ACE     inhibition and smoking further increases bradykinin concentrations. During CPB, bradykinin     concentrations correlate inversely with mean arterial pressure and directly with t-PA.     Moreover, we have found that bradykinin receptor antagonism attenuates protamine-related     hypotension following CPB. The current proposal tests the central hypothesis that the     fibrinolytic and inflammatory response to cardiopulmonary bypass differ during     angiotensin-converting enzyme inhibition and angiotensin II type 1 receptor antagonism.   "
211331|NCT00610350|"     The aim of this study is to investigate whether pharmacological pre-treatment with     levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective     myocardial revascularization under cardiopulmonary bypass.   "
211205|NCT00607685|"     Trabeculectomy is the most effective method of lowering intraocular pressure in glaucoma that     is not well controlled with drop medication. The post-operative wound healing response     remains the major barrier in surgical success. Scar tissue formation results in occlusion of     the surgical drainage site created. As a consequence, the intraocular pressure rises once     again. The current use of anti-scarring agents such as 5 Fluorouracil (5FU), is a well     established method employed by ophthalmologists to clinically reduce the postoperative     scarring response. However, in patients with a high risk of bleb failure, repeated     subconjunctival injections of 5FU following bleb needling is often required resulting in     increased clinical load and patient inconvenience. A slow release formulation of 5FU would be     of benefit by releasing the 5FU into the subconjunctival space over an extended period     thereby providing a prolonged therapeutic effect. In addition, hyaluronic acid is known to     possess antifibrotic properties and from its gel-like physical state, would potentially act     as a physical tissue spacer that may further limit active subconjunctival scarring at the     site where it is injected. We hypothesise that injecting a mixture of 5FU with hyaluronic     acid would give better outcomes than injecting 5FU alone.      The aim of this study is to determine whether bleb needling with subconjunctival injection of     Viscoelastic/5FU formulation is an effective method for prolonged drug delivery in preventing     the post-operative scarring response. This will be a prospective case-controlled study     involving patients who have already undergone trabeculectomy and who require bleb needling     and subconjunctival 5FU injections.   "
211206|NCT00607711|"     The study of maximum tolerated dose and safety of oral palifosfamide tris capsules in     advanced, refractory, solid tumors   "
211207|NCT00607724|"     RATIONALE: Drugs used in chemotherapy, such as GDC-0449, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I trial is studying the side effects and best dose of GDC-0449 in     treating patients with locally advanced or metastatic solid tumors.   "
211208|NCT00607737|"     To compare application site reactions after superficial and deep subcutaneous and intradermal     injections of insulin detemir and saline in patients with diabetes      - The patient serves as his own control, n=100 patients with diabetes   "
211209|NCT00607750|"     This study is a double-masked, randomized, placebo-controlled study of the safety and     preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance     injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be     effective in the treatment of neovascular AMD.   "
211210|NCT00607763|"     Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an     antifungal drug. Safety and drug blood levels will be assessed   "
211211|NCT00607776|"     The mean change in the subjective comfort score from baseline of the test group is at least     2.0 units less than that of the control group.   "
211212|NCT00608725|"     The purpose of this study is to describe the mechanism of orthostatic intolerance, relying on     cardiovascular physiological studies. The syndrome is of undetermined etiology, but the     syndrome causes impairment of a number of young adults, females more than males, with     symptoms of tachycardia, fatigue, lightheadedness, palpitations, blurred vision, chest     discomfort, difficulty concentrating, and dizziness with the upright posture. It is believed     that many different pathophysiological processes can give rise to this disorder.   "
211213|NCT00608738|"     RATIONALE: Gathering information about patients with cancer and cancer-related conditions may     help doctors learn more about a patient's needs and help doctors plan the best treatment.      PURPOSE: This clinical trial is studying how well a whole-person-care guide works in     identifying patient needs in patients with cancer or complications from cancer treatment.   "
211214|NCT00608751|"     Patients with head and neck cancer and are schedule to receive standard radiation therapy     known as IMRT to treat cancer   "
211215|NCT00608764|"     Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is often caused     by cigarette smoking. The purpose of this study is to evaluate whether certain genetic     factors predispose some smokers to develop COPD more than others.   "
211216|NCT00608777|"     The purpose of this study is to determine if calcipotriene/bethamethasone can safely and     effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving     efalizumab (Raptiva) for moderate to severe plaque psoriasis.      It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB     and thus allow patients to continue efalizumab without interruption.   "
211217|NCT00608790|"     The purpose of this study is to test whether a saline nebulization (breathing in a mist of     moist air through a mask) will help an individual cough up a better sputum sample to test for     tuberculosis (TB). In addition, this study will test whether samples obtained with saline     nebulization are better at finding TB in people with HIV infection. The study will enroll up     to 600 individuals, aged 12 and older, with suspected pulmonary TB. Participants will be     asked to cough up a sample of sputum into a container. Then, participants will be asked to     breathe a mist of moist air from an oxygen mask followed by moist salty air, which will help     individuals to cough up a second sputum sample. This mist of moist air will contain     salbutamol, a medicine to help open up the airways. The sputum samples will be sent to a     laboratory to test for TB. Additionally, participants will be tested for HIV with a blood     sample collection. Participants will be involved in study related procedures for up to 61     days.   "
211218|NCT00608803|"     The study of safety of ZIO-201-T in combination with doxorubicin in the treatment of advanced     cancer.   "
211219|NCT00608816|"     Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the     hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and     cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.   "
211220|NCT00608829|"     The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in     subjects with aneurysms of the descending thoracic aorta.   "
211221|NCT00608842|"     The purpose of this research is to compare the safety and effectiveness of 3 different     concentrations of deoxycholic acid for injection against a placebo in the treatment of     superficial lipomas.   "
211222|NCT00608855|"     RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases.      PURPOSE: This clinical trial is studying the side effects and how well percutaneous     cryoablation works in treating patients with painful bone metastases.   "
211223|NCT00608868|"     The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a     second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid     Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type     of tumor.   "
211224|NCT00608881|"     The goals of this trial are to determine if coenzyme Q10 is effective in slowing the     worsening symptoms of Huntington's disease and to learn about the safety and acceptability of     long-term coenzyme Q10 use by determining its effects on people with Huntington's disease.   "
211225|NCT00608894|"     An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety     and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination     with prednisone, for the treatment of autoimmune hepatitis (AIH).   "
211226|NCT00608907|"     The primary purpose of this Phase I study is to evaluate the effect of the co-administration     of CYP3A4 inducers on the pharmacokinetics profile of VELCADE (bortezomib). Rifampicin will     be used to assess the effect of a strong CYP3A4 inducer and dexamethasone to assess the     effect of a relatively weak inducer. This study is also to evaluate the impact of CYP3A4     inducers on the pharmacodynamics (PD) of VELCADE and the safety profile of VELCADE.   "
211227|NCT00608920|"     The purpose of this study is to determine if the planning of radiation treatment of prostate     cancer patient can be made more precise by comparing currently planning techniques to an     imaging technique called SPECT.   "
211228|NCT00608933|"     RATIONALE: Educating health providers on talking with cancer patients about complementary and     alternative medicine (CAM) may help encourage health providers to talk more often with cancer     patients about the use of CAM.      PURPOSE: This randomized phase III trial is studying how well an education intervention works     in encouraging health providers to talk with cancer patients about the use of CAM.   "
211229|NCT00608946|"     The efficacy of 8 mg of copper daily regarding cognitive function, content of beta amyloid     protein in the CSF and volumetric changes in the brain will be examined in a first     double-blind, placebo-controlled human clinical trial conducted in 70 patients with mild     Alzheimer´s dementia.   "
211230|NCT00608959|"     The purpose of this research study is to determine if omiganan 1% gel (the investigational     medication in this research study) is effective and safe when compared to chlorhexidine 2%     (an FDA approved medication) for killing bacteria (germs) that live on the surface of the     skin. Both of the study medications are applied topically (on the surface of the skin).   "
211295|NCT00609882|"     We hypothesize that the success rate for keeping babies extubated (without a breathing tube     for assisted mechanical ventilation), defined as the proportion of infants remaining     extubated for a minimum of 72 hours, will be equivalent among infants managed with nasal CPAP     compared to humidified high flow nasal cannula (HHFNC).   "
211231|NCT00608972|"     The purpose of this research study is to look at the effectiveness of a combination of doxil,     carboplatin and bevacizumab on metastatic breast cancer. The type of breast cancer being     studied is negative for a protein called HER2/neu and for estrogen receptors (ER) and     progesterone receptors (PR). HER2/neu, ER and PR are part of a family of receptors found on     both cancer and normal cells. This family of receptors is important for cell growth and is     found in many tumor types.This study is being conducted for the following research purposes:·     To find out what effects, if any, the study drug has on metastatic breast cancer. For     instance, will the study drug cause the tumor(s) to shrink or stop growing?· To test the     safety of the study drugs and to see what affects it has. For instance, are there any side     effects? If so, what kind of side effects does the study drug cause? How severe are the side     effects, and how often do they occur?· To see if the study drugs have any effect on keeping     the disease from getting worse.   "
211232|NCT00608985|"     A polysomnography study to evaluate the effect, safety and tolerability of oral     administration of almorexant (ACT 078573) in adult subjects with primary insomnia.   "
211233|NCT00608998|"     The aim of this study is to appreciate the influence of renal failure progression on     vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular     risk factors.   "
211234|NCT00609011|"     This is an open-label, dose finding, multiple-dose study in subjects with metastatic     melanoma. Three dose levels of MPC-6827 will be administered with temozolomide to three     separate cohorts. Study endpoints will include determination of the maximum tolerated dose,     determination of dose limiting toxicities, and evaluation of evidence of anti-tumor activity     of MPC-6827 when given with temozolomide.   "
211235|NCT00609037|"     The primary aim of our study is to test the hypothesis that wound healing is impaired in the     patient who has experienced massive weight reduction following gastric bypass for morbid     obesity. Specifically we will document post-surgical local complications and evaluate     multiple wound healing parameters in two patient populations in a prospective fashion. The     test group will consist of patients who have undergone dramatic weight loss and are much in     need of a panniculectomy due to excessive skin redundancy. The control group will consist of     patients within normal weight ranges who are seeking an abdominoplasty.   "
211236|NCT00609050|"     The aim of this study is to test the effect of a 6-month program of self-regulated,     home-based exercise with telephone reinforcement on the cardiorespiratory fitness, pulmonary     function and health-related quality of life of children with cystic fibrosis (CF), compared     to controls. Exploring the exercise experiences of the children and parents is a secondary     aim.   "
211237|NCT00609063|"     Statins are a group of medications that are used to lower cholesterol levels. Although     serious side effects are rare, some people taking statins experience muscle pain or weakness.     This study will evaluate the number of people who experience mild muscle complaints and will     determine the effect of statins on skeletal muscle strength, endurance, and aerobic exercise     performance.   "
211238|NCT00609089|"     The planned research will adapt an intervention of known efficacy to target a new outcome of     significant importance to public health. Specifically the Community Reinforcement and Family     Training (CRAFT) procedures will be adapted, from reinforcing treatment entry, to reinforcing     treatment retention and HIV risk behavior reduction in persons with opioid dependence who     receive a Buprenorphine taper detoxification. The research plan includes three phases: 1)     development of a manual guided therapy, 2) development of therapist training and fidelity     measures and 3) a randomized pilot evaluation with 52 patients receiving either the new CRAFT     treatment or treatment as usual.   "
211240|NCT00609115|"     The AMES device is designed to produce functional cortical changes by:(1) assisting the     subject as he/she attempts to move the limb (assisted movement) and (2) enhancing movement     sensation by vibrating the muscles during movement (enhanced sensation). The primary     hypothesis is that the combination of assisted movement and enhanced sensation from muscle     vibration can increase the amount of motor recovery in individuals disabled by a stroke.   "
211241|NCT00609128|"     The purpose of the research is to determine which inflammatory substances are involved in     causing allergic symptoms in the eye. Allergic conjunctivitis is a common problem with     symptoms of temporary redness, itching, tearing, and swelling of the eyes. Substances     released by cells in the affected tissues cause allergic reactions in the eye and elsewhere     in the body.   "
211242|NCT00609141|"     This phase I clinical trial is studying the side effects and best dose of IMC-A12 in treating     young patients with relapsed or refractory Ewing sarcoma/peripheral primitive neuroectodermal     tumor or other solid tumors. Monoclonal antibodies, such as IMC-A12, can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or carry cancer-killing substances to them.   "
211243|NCT00609154|"     The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on     maintaining the function and health of the insulin producing beta cells. This hormone is     known to increase the production rate of new insulin as well as increase the release of     insulin into the blood. We will measure the rate of new insulin production in subjects with     Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2     diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.   "
211244|NCT00609167|"     RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and dexamethasone work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Giving cyclophosphamide and dexamethasone together with     bortezomib may kill more cancer cells.      PURPOSE: This phase II trial is studying giving cyclophosphamide and dexamethasone together     with bortezomib to see how well it works in treating patients with newly diagnosed multiple     myeloma.   "
211296|NCT00609895|"     To compare the percentage of subjects with a glucose measurement < than or = to 56 mg/dL at     any point of the 8-point glucose profiles during 3 consecutive days before vs. 3 consecutive     days after switching insulin glargine dosing time from bedtime to morning and vs. 3     consecutive days after switching back to bedtime dosing of insulin glargine.   "
211245|NCT00609180|"     Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions     that occur when there is severe inflammation and increased fluids in both lungs, making it     difficult for the lungs to function properly. Hospital treatment for a person with ALI/ARDS     often includes the use of a breathing machine, or ventilator, until the person is able to     breathe without assistance. Initiating proper nutrition through a feeding tube early in a     person's hospital stay may help to improve recovery, but the optimal timing, composition, and     amount of feeding treatments are unknown. This study will evaluate whether early or delayed     full-calorie feeding through a feeding tube is more effective in reducing recovery time and     increasing survival rates in people with ALI/ARDS. The study will also determine whether     supplementing the feedings with omega-3 fatty acids and antioxidants benefits people with     ALI/ARDS.   "
211246|NCT00609193|"     The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain     structure, function and chemistry in people with bipolar disorder who are being treated with     either quetiapine or lithium. Both of these medicines are FDA-approved to treat mania in     adults and lithium is also FDA approved in children; quetiapine is commonly used in children     with mania, but is not FDA approved for this indication in this age group.   "
211247|NCT00609219|"     Patients have a type of cancer called nasopharyngeal cancer. This cancer has come back or not     gone away or is at high risk for coming back after treatment (including the best treatment we     know for nasopharyngeal cancer). We are asking patients to volunteer to be in a research     study using special immune system cells called EBV-specific cytotoxic T lymphocytes, a new     experimental therapy.      Most patients with nasopharyngeal cancer show evidence of infection with the virus that     causes infectious mononucleosis, Epstein Barr virus (EBV), before or at the time of their     diagnosis of nasopharyngeal cancer. EBV is found in the cancer cells of most patients with     nasopharyngeal cancer, suggesting that it may play a role in causing this cancer. The cancer     cells infected by EBV are able to hide from the body's immune system and escape destruction.     We want to see if special white blood cells (called T cells) that have been trained to kill     EBV-infected cells can survive in the patient's blood and affect the tumor.      We have treated other patients with different EBV positive cancers and have had variable     results. Some patients have had some response to the treatment. Some patients have been cured     by the treatment. It is not possible for us to predict if this treatment will work for     nasopharyngeal cancer.      The purposes of this study are to find the largest safe dose of EBV specific cytotoxic T     cells, to learn what the side effects are, and to see whether this therapy might help     patients with nasopharyngeal cancer.   "
211248|NCT00609245|"     We are trying to learn if small changes in the amount of a valproate in the blood (given     through an IV) will change the way the brain reacts to flashing lights.   "
211249|NCT00609271|"     The objective of this trial is to examine the long-term effects of a diet low in     carbohydrates, as compared to one low in fat, on cardiovascular disease risk factors,     including blood pressure (BP), body weight and composition, serum lipids, plasma glucose,     insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among     obese adults.      The investigators will test the following hypotheses:      Hypothesis 1: Compared to a low fat diet, a diet low in carbohydrates will reduce systolic     and diastolic BP over 12 months; Hypothesis 2: Compared to a low fat diet, a diet low in     carbohydrates will reduce body weight, total percent body fat, and waist circumference over     12 months; Hypothesis 3: Compared to a low fat diet, a diet low in carbohydrates will reduce     serum levels of LDL-cholesterol and triglycerides and increase serum levels of     HDL-cholesterol over 12 months; Hypothesis 4: Compared to a low fat diet, a diet low in     carbohydrates will reduce plasma levels of glucose and insulin levels over 12 months; and     Hypothesis 5: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma     levels of leptin, resistin, and CRP and increase plasma levels of adiponectin over 12 months.   "
211251|NCT00609297|"     RATIONALE: Gathering information over time about cancer-related pain from patients in a     hospice and their caregivers may help doctors learn more about pain control.      PURPOSE: This clinical trial is studying how well standard pain control works in hospice     patients with cancer-related pain.   "
211252|NCT00609310|"     Prove the hypothesis that dietary supplementation with bioflavonoids will diminish the     recurrence rate of colonic neoplasia, we will implement a clinical trial comparing     bioflavonoids and placebo in a double blind randomized clinical trial. To use a standardised     supplementation of bioflavonoids, a commercially available preparation (Flavo-Natin®) will be     used.   "
211253|NCT00609323|"     Pliaglis™ (lidocaine and tetracaine) Cream 7%/7% is a topical local anesthetic cream that     forms a pliable peel on the skin when exposed to air. When applied to intact skin, Pliaglis     provides local dermal analgesia by the release of lidocaine and tetracaine from the peel into     the skin.      Pliaglis is currently approved in the United States for use on intact skin in adults to     provide topical local analgesia for superficial dermatological procedures such as dermal     filler injection, pulsed dye laser therapy, and facial laser resurfacing.      This study will evaluate lidocaine and tetracaine cream 7%/7% for the treatment of pain     associated with postherpetic neuralgia (PHN).   "
211254|NCT00609336|"     This phase II trial studies how well giving combination chemotherapy together with     intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with     localized pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such     as gemcitabine hydrochloride, docetaxel, capecitabine, and oxaliplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized     radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor     may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug     (combination chemotherapy) together with intensity-modulated radiation therapy before surgery     may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.     Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.   "
211773|NCT00615836|"     The purpose of this study was to investigate the long term efficacy and safety of several     doses of the Melt formulation of desmopressin in a broad population of adult patients with     nocturia.   "
211255|NCT00609349|"     The early detection of pulmonary arterial hypertension may help to improve prognosis of the     disease. It is assumed that in the early stages of pulmonary arterial hypertension, pulmonary     arterial pressure values may be normal at rest, but the remodelling of small arteries leads     to stiffening resulting in increased pulmonary arterial pressure during exercise. In the     present study we investigate patients with risk factors for pulmonary arterial hypertension     (e.g. connective tissue disease) by combining exercise tricuspid echo doppler and     cardiopulmonary exercise test to screen patients for exercise-induced pulmonary hypertension     and control the results by the gold standard right heart catheterisation at rest and during     exercise. We expect that using this screening method, patients with pulmonary arterial     hypertension would be recognized earlier.   "
211256|NCT00609362|"     Osteoporosis is a generalised bone disease leading to an increased risk of fractures. The     disease is caused partly by environmental and partly by genetic factors. It is well known     that the fat content of the bone marrow is increased in osteoporotic patients. Animal studies     suggest that stimulation of bone marrow stem cells through the molecule PPARgamma with the     drug rosiglitazone converts the stem cells to fat cells instead of bone cells thereby     decreasing bone strength. In a single study healthy volunteers were treated with     rosiglitazone for 14 weeks and had a decrease in bone mineral density.      In the present study we wish to investigate the effect of this treatment on bone and fat     tissue. 25 women above the age of 60 will be treated with rosiglitazone 8 mg/day for 14 weeks     and compared with 25 women receiving placebo.      The effect will be evaluated as follows:        1. The effect on bone marrow density will be examined by a bone scan prior to and after          treatment and again after 6 and 9 months.        2. The effect on bone turnover will be measured in blood- and urine samples at the same          times.        3. The effect on fat distribution will be evaluated by an MRI scan after treatment.        4. The effect on bone marrow cells will be investigated bone marrow sampling immediately          after treatment        5. The direct effect on fat will be examined by a biopsy immediately after treatment The          study hypothesis is that rosiglitazone treatment decreases bone mineral density and          increases bone marrow fat content. The causal molecular mechanisms will be investigated          from the bone marrow and fat samples   "
211257|NCT00609375|"     To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous     infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in     Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate     of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and     rates of relapse after 28 days.      Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or     microbiological cure greater than the intermittent administration.   "
211258|NCT00609388|"     The evaluation of the efficacy of an intraportal infusion with Tacrolimus, at the time of     liver graft implantation, compared to a control group without immunosuppressive intraportal     infusion (Placebo: Saline solution 0.9%) with respect to the initial liver function measured     by the parameters of the liver function (LFP): AST (U/L), ALT (U/L), total Bilirubin (mg/dL)     and the coagulation factors: NT (%), PTT (s), INR.   "
211259|NCT00609401|"     The ROSORC trial is a randomized study comparing the efficacy of a new association (sorafenib     and IL-2) versus the standard therapy (sorafenib) in patients affected by different     histotypes of metastatic RCC. This study is a first line therapy for the advanced disease.     The primary objective is the progression free survival (PFS) in the 2 arms of therapy and the     secondary objective is the overall survival (OS) and the response rate (RR) and the safety     profile of the combination compared to sorafenib alone.   "
211260|NCT00609414|"     This is a study of why and how physicians use albumin during the first 72 hours after a burn     injury.   "
211261|NCT00609427|"     The purpose of this study is to evaluate the effects of training in memory skills vs. use of     external memory aids on everyday memory functioning in older people with mild cognitive     impairment.   "
211262|NCT00609440|"     OBJECTIVES: Relating about the benefits proportionated by the physiotherapeutic treatment for     the patients that have the Morquio's syndrome. METHODS: This study intends to analyse a     patient that presents this syndrome, describing the physiotherapeutic treatment that was     proposed and the evolution clinical.   "
211263|NCT00609453|"     The goal of the proposed research is to examine the neural correlates of depressive symptom     reduction in individuals with major depressive disorder using functional magnetic resonance     imaging (fMRI), and to compare results to those obtained from a nondepressed control group.   "
211264|NCT00609466|"     The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose     application of oral application of CG5503 IR 75mg compared to placebo and to assess safety     and tolerability of CG5503 IR 75mg in subjects following bunionectomy.      This trial was performed based on a previously performed double-blind, placebo-controlled,     multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75     and 100 mg) published under PMID: 18851776.   "
211265|NCT00609479|"     The purpose of this study is to compare two different fixationmethods for fractures of the     wrist(distal radius fractures). We are comparing an external fixation     (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Primary endpoint is patient     satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength,     PRWE-questionnaire.   "
211266|NCT00609492|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a     booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine     co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born     children at the age of 16-18 months. This protocol posting deals with objectives & outcome     measures of the booster phase. The objectives & outcome measures of the primary phase are     presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating     in this study should have received three doses of pneumococcal vaccine in the primary study.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
211324|NCT00610259|"     The purpose of this study is to examine the effectiveness of brief behavioral therapy for     insomnia (bBT-I) in addition to treatment as usual (TAU) in comparison with TAU alone for     refractory insomnia among patients with major depression in partial remission.   "
230095|NCT00866424|"     The purpose of this study is to determine whether the hyperbaric oxygen treatment reduces     pain and improve the life quality in trigeminal neuralgia patients.   "
211267|NCT00609505|"     Cancer genetic counseling (CGC) has been found to have substantial benefits for individuals     with breast cancer and their family members; it has been deemed by multiple organizations as     standard of care for women with breast cancer and their relatives. Unfortunately, there is     a disparity in access to CGC, especially among women who live in rural and underserved areas.     In North Carolina, only two cancer genetic counselors practice in rural clinics - each only     for a few days per month. Therefore, in an effort to make CGC more widely available in a     timely manner, we propose to test provision of counseling through telemedicine (TM), in which     a patient and health care provider communicate with each other using videoconferencing. In 4     rural oncology clinics, we will implement low-cost TM and compare satisfaction and     cost-effectiveness between groups of women designated to have their CGC session by TM or FTF.     We'll use a validated measure to assess satisfaction by a phone survey one week after the CGC     appointment; cost-effectiveness will be measured at project's end by calculating length of     wait time for appointment and costs of equipment, labor, and mileage. Study hypothesis: TM is     as satisfactory as FTF counseling and is a more cost-effective way to provide this beneficial     service.   "
211268|NCT00609518|"     Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given     folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side     effects associated with pemetrexed. The aim is whether it is possible to simplify the folic     acid and steroid schedule without increasing toxicity.   "
211269|NCT00609531|"     The purpose of this proof of concept study is to use functional magnetic resonance imaging     and behavioral assessments to investigate the effect of citalopram on restricted repetitive     behaviors in people with autism spectrum disorders.   "
211270|NCT00609544|"     Anemia of inflammation is a common complication in patients with chronic kidney disease     (CKD). Patients with CKD and anemia of inflammation also exhibit decreased response to     erythropoietic agents, even in the presence of adequate iron stores. This decreased     responsiveness is associated with increased levels of proinflammatory cytokines. Rilonacept     is being developed for the treatment of inflammatory disorders.      This is a clinical research study to determine the safety and effectiveness of rilonacept for     the treatment of anemia in inflamed patients with CKD who are not yet on dialysis.   "
211271|NCT00609557|"     This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may     receive duloxetine or placebo during the course of the trial. All subjects will, in fact,     receive placebo for the first two weeks. All subjects will then be placed on 60-90mg per day     of duloxetine. Primary outcome assessment will compare pain intensity at 2 weeks (after     placebo) to that at 12 weeks (after 10 weeks of duloxetine treatment).      Study Hypothesis:      In subjects who continue to have activity-limiting osteoarthritis pain after treatment with     acetaminophen or non-steroidal anti-inflammatory agents, 60-90 mg Duloxetine per day over 10     weeks will provide significant additional pain relief over that achieved with placebo(> 30%     reduction after Duloxetine treatment).   "
211272|NCT00609570|"     Three different supplements will be used in the study (fruits and vegetable powders, whey     protein and calcium) for patients with hypertension. The null hypothesis was that the     supplements had no effects on participants' blood pressure.   "
211273|NCT00609596|"     Dutasteride and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when     given together, there is more improvement in symptoms than either drug alone. In this study,     we are looking to see if 2 different formulations of tamsulosin in our combination capsules     are the same after 7 days of dosing as the US commercial tamsulosin and dutasteride.   "
211274|NCT00609609|"     The goal of this clinical research study is to find out whether adding extracorporeal     photopheresis (ECP) to standard therapy for acute GVHD with corticosteroids improves response     to treatment, length of treatment, and survival.   "
211276|NCT00609635|"     This research study involves studying the genes that may affect how ill you become during     respiratory infection with respiratory syncytial virus (RSV). RSV is a virus that often     causes common colds.      Cytokines are chemicals that are naturally made by your body. Cytokine levels are increased     in some people when they have common colds or wheezing caused by respiratory syncytial virus     (RSV). The purpose of this study is to study the genes that may control cytokine levels     during infection with RSV in the elderly population.   "
211277|NCT00609648|"     This is a randomized study in which two groups will be used to compare the effectiveness of a     computerized psychological therapy compared to an information only control group (pamphlet)     for reducing fear of dental injections.   "
211278|NCT00609661|"     This study is designed to determine the response of adult stems cells, also referred to as     mesenchymal stem cells (MSCs), to tissue injury resulting from thermal burns. The study will     consist of a one time collection of a patient's blood, about one teaspoon, on the third day     following the initial burn. MSCs in the blood will then be quantitated and identified using     according to unique proteins found on their cell surface using flow cytometry. The results of     flow cytometry analysis will then be compared to the patients characteristics (age, sex,     race, etc.), their past medical history (hx of diabetes, hypertension, heart disease, etc.)     and to the patient outcome (length of hospital stay, mortality, etc.).   "
211279|NCT00609674|"     The purpose of this study is to compare the effects (effectiveness and safety) of an     intranasal corticosteroid (fluticasone furoate nasal spray [FFNS]), with a placebo nasal     spray for the treatment of perennial (year-round) allergic rhinitis.   "
211294|NCT00609869|"     The purpose of this research is to evaluate the use of Rituximab in combination with Revlimid     in the treatment of refractory Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia     (CLL). Revlimid® is a drug that changes the immune system and it may also get in the way with     the growth of tiny blood vessels that help support tumor growth. Therefore, in theory, it may     reduce or prevent the growth of cancer cells. Revlimid® is approved by the Food and Drug     Administration (FDA) for the treatment of specific types of Myelodysplasia syndrome (MDS) and     Multiple Myeloma, two different types of blood cancer. It is currently being tested in a     variety of cancer conditions. In this case it is considered experimental.   "
211280|NCT00609687|"     The usefulness of diagnostic vitrectomy in patients with suspected sarcoidosis with posterior     segment involvement (in whom a diagnosis cannot be determined by conventional methods) has     not been well described. We hypothesized that diagnostic vitrectomy would help establish the     diagnosis in these challenging cases. Herein, we evaluated the diagnostic yield of vitreous     biopsy in patients with suspected sarcoidosis-associated uveitis that affected the posterior     segment.This is a retrospective interventional case series. Cases of intermediate, posterior     or panuveitis that could not be characterized by clinical examination, ancillary, and     laboratory tests were considered for diagnostic pars plana vitrectomy. Retrospective chart     review was conducted on consecutive eyes that underwent diagnostic, or diagnostic and     therapeutic vitrectomy by a single surgeon from January 1989 to June 2006.   "
211281|NCT00609700|"     This observational study compares the influence of Ringer's Lactate solution and Ringer's     Acetate solution on organ function scores following severe burn injury.   "
211282|NCT00609713|"     The long-term goal of this proposal is to understand the impact of obesity and obesity     treatment on bone health during adolescence and how to preserve it. The recent pediatric     obesity epidemic raises important clinical and public health questions about the effects of     childhood-onset obesity and its treatment on bone health. Osteoporotic fractures are a major     cause of morbidity and mortality in the aged, and peak bone mass (PBM), achieved shortly     after puberty, is a key determinant of bone strength and lifetime fracture risk. Given the     current obesity epidemic, obesity treatment during adolescence will continue to be necessary.     The benefits of pediatric obesity treatment are unquestionable. However, the potential     detrimental effects of weight loss on bone density and dimensions are not known in     adolescents and are the focus of this proposal.      This study will focus on the impact of pediatric-onset obesity and its treatment on bone     health, using two approaches: comparing obese and non-obese adolescents and comparing obese     adolescents before and after weight loss. We hypothesize that (a) compared to non-obese     controls, obese adolescents have stronger bones, and that (b) bone strength of obese     adolescents decreases during weight loss compared to usual care, which would suggest a need     to promote bone health during successful weight loss in obese adolescents.   "
211283|NCT00609726|"     The purpose of the study is to determine the best evaluation for patients with idiopathic     (unexplained) pancreatitis.   "
211284|NCT00609739|"     RATIONALE: Giving chemotherapy drugs, such as cytarabine and mitoxantrone, before a donor     stem cell transplant helps stop the growth of cancer cells and helps stop the patient's     immune system from rejecting the donor's stem cells. When certain stem cells from a donor are     infused into the patient they may help the patient's bone marrow make stem cells, red blood     cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can     make an immune response against the body's normal cells. Giving cyclosporine, methotrexate,     and methylprednisolone before or after transplant may stop this from happening.      PURPOSE: This phase I/II trial is studying the side effects and best way to give high-dose     cytarabine together with mitoxantrone in treating patients with juvenile myelomonocytic     leukemia undergoing a second donor stem cell transplant.   "
211285|NCT00609752|"     This study will compare two current first-line treatments for childhood Crohn's Disease,     steroids versus a liquid diet, and determine the effects of these treatments on bone health,     quality of life and treatment efficacy.   "
211286|NCT00609765|"     Open label, single-arm phase II study of avastin combined with fluorouracil, doxorubicin and     streptozocin administered in 28-day cycles. Treatment will continue until progression of     disease, or until withdrawal due to toxicity, or up to a maximum of 12 cycles (48 weeks). In     order to reduce the risk of cardiac toxicity, doxorubicin will be administered for a maximum     of 8 cycles. If disease has not progressed after 12 cycles of treatment, avastin monotherapy     will continue until disease progression or withdrawal due to toxicity.   "
211287|NCT00609778|"     The primary objective is to show superiority in survival of the modified method with the     LUCAS Chest Compression System, compared to the conventional manual resuscitation method in     patients suffering from out of hospital sudden cardiac arrest.   "
211288|NCT00609791|"     RATIONALE: Gathering information from patients of different ages receiving paclitaxel     albumin-stabilized nanoparticle formulation for metastatic breast cancer may help doctors     understand how the age of the patient changes the way the drug works.      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle     formulation works in treating patients of different ages with metastatic breast cancer.   "
211289|NCT00609804|"     This is a randomized, open-label, multi-center, Phase II study of treatment of patients with     advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and     erlotinib or sorafenib alone.   "
211290|NCT00609817|"     A Phase 1, open-label, dose escalation, multi-center study in patients who have been     diagnosed with multiple myeloma and who have relapsed or have refractory/relapsed disease     after treatment with at least 2 prior therapies.   "
211291|NCT00609830|"     The ultimate objective of the proposed research is to improve the health-related quality of     life of individuals with rheumatoid arthritis by reducing their risk of developing     osteoporosis secondary to glucocorticoid therapy. The study has four specific aims.      Specific Aim 1: To obtain descriptive information concerning patients' knowledge, beliefs and     behaviors with respect to osteoporosis and osteoporosis prevention.      Specific Aim 2: To identify factors that discriminate among patients in different stages of     change with respect to each behavior of interest.      Specific Aim 3: To compare the effects of tailored versus generic educational materials on     patient adherence to the ACR Guidelines for the Prevention of Glucocorticoid-Induced     Osteoporosis.      Specific Aim 4: To determine if the effects of tailored educational materials are enhanced by     concurrent feedback of information concerning patients' behavioral risk factor status to     their physicians.   "
211292|NCT00609843|"     Rationale: Bladder tumours are often not visible on X-ray based image-modalities during     planning and treatment of Radiotherapy.      Purpose: To determine if a single contrast (Lipiodol) demarcation of the bladder tumour     before treatment is feasible and visible on multiple X-ray based image-modalities during     Radiotherapy.   "
211293|NCT00609856|"     Pioglitazone and insulin glargine are equally effective in achieving glycemic control in     secondary drug failure of type 2 diabetes but the mechanisms of actions are different.   "
211297|NCT00609908|"     Objective:      A randomized controlled trial is performed to evaluate the clinical effectiveness of the skin     stretching technique for two categories:        1. acute burn wounds: wound closure by means of skin stretching should lead to a          significant reduction of scar surface area in comparison to the standard technique, the          split skin grafting;        2. scar reconstructions: wound closure by means of skin stretching during one operative          procedure should lead to a comparable scar surface in comparison to the multiple          procedures techniques such as serial excision.      Study design:      Skin stretching will be compared to split skin grafting and should result in burn wound     closure with significantly smaller scars. Also, a comparison will be made between the     technique of serial excision versus skin stretching for scar reconstructions.      Scar evaluation three and twelve months after surgery will include the following parameters:        -  surface area;        -  Patient and Observer Scar Assessment Scale (POSAS);        -  elasticity;        -  vascularization and pigmentation;        -  thickness;        -  dermal architecture.      After 12 months adults will undergo a biopsy of the scar under local anesthesia. The     experimental group, treated with the skin stretcher will undergo one extra biopsy of the     formerly stretched skin.      Intervention:      At the start of the operation will be determined by randomization if skin stretching or split     skin grafting (acute burn wounds) or serial excision (scar reconstruction category) will be     performed.   "
211298|NCT00609921|"     This is a Phase 1, open label, dose escalation study of ARQ 197 in patients with     advanced/recurrent solid tumors. The purpose of this study is to determine the safety,     tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.   "
211299|NCT00609934|"     The purpose of this study is to investigate the use of a new anti-angiogenic drug called     sorafenib, in combination with radiotherapy, for renal cell cancer that has spread to the     bone and is causing significant pain. The study will find a safe dose of sorafenib for this     combination study treatment, look at side effects, and test if the study treatment is     effective in controlling the pain experienced from this type of renal cell cancer. . There     will be two parts or phases to this study      The purpose of the first phase is to find the highest dose of sorafenib that can be given     safely to patients, when combined with radiotherapy. We will also see what kind of effects     the study treatment has on you and your cancer. Participants in this phase will receive a     dose of sorafenib that has shown to be well-tolerated in humans. If the side effects are     tolerable for this dose of sorafenib when combined with radiotherapy, new patients will be     asked to join the study and will receive a dose of sorafenib higher than the last study     participant.      In the second phase, new study participants will receive the dose of sorafenib that was     determined to be safe in the first phase. Side effects will continue to be looked at and the     effectiveness on controlling pain symptoms from this type of cancer, will also be looked at.   "
211300|NCT00609947|"     The objective of this study is to verify the safety and efficacy of the Endeavor     Zotarolimus-Eluting Coronary Stent System for improving coronary luminal diameter in patients     with ischemic heart disease due to de novo lesions of length ≤27 mm in native coronary     arteries with reference vessels ≥ 2.25 mm to ≤ 2.75 mm.   "
211301|NCT00609960|"     This study wants to test the hypothesis that trained clowns can reduce anxiety in children     undergoing general anesthesia. We will compare the effect of the clowns to the commonly used     anti-anxiety medication we commonly use   "
211317|NCT00610168|"     The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in     adults 10 years after previous booster vaccination with dTpa in a prior clinical study. Only     subjects who received booster vaccination in the previous clinical study are eligible for     participation in this study.   "
211332|NCT00610363|"     This was a clinical research study to determine the safety and effectiveness of an     experimental drug called rilonacept in participants with gout who were beginning another     additional treatment. Participants participated in this study for approximately 24 weeks.     Rilonacept was being studied for use in preventing gout attacks in participants who had gout.   "
211333|NCT00610376|"     The primary objective of this preschool intervention trial was to determine whether a hygiene     program can promote handwashing and thereby reduce illness absenteeism.   "
211302|NCT00609973|"     Despite extensive medical treatment, surgical resection is required in approximately 70% of     the patients at some time. However, recurrence of the disease after operation occurs in the     majority of patients and is a serious limitation of surgical management. Therapeutic options     to maintain postoperative clinical remission are urgently needed. Several drugs including     mesalazine, antibiotics (metronidazole, ornidazole) and azathioprine or 6-mercaptopurine have     been studied in the past. But the efficacy is very limited (mesalazine), overshadowed by     intolerability during long-term therapy (metronidazole, ornidazole) or inconclusive     (azathioprine or 6-mercaptopurine). Research demonstrating the absence of inflammation in     patients with diverting ileostomy and the clinical benefit of a postoperative antibiotic     therapy using metronidazole or ornidazole implicates a role of the resident bacterial flora     in the postoperative relapse. Ciprofloxacin has a broad antibacterial spectrum. More     interestingly it also suppresses E. coli strains, which can be found in high numbers in early     and chronic ileal lesions of Crohn's disease patients Ciprofloxacin has demonstrated     beneficial effects in the therapy of inflammatory bowel diseases, but the available data of     the effectiveness of ciprofloxacin allow only a very limited judgement of the safety and     tolerability of a 6 months therapy of ciprofloxacin. Therefore an exploratory multicenter     prospective, placebo-controlled trial is planned to analyze the safety and tolerability of a     6 months therapy with ciprofloxacin compared to placebo in 40 patients (randomly assigned in     a 1:1 ratio) undergoing ileocecal resection (or resection of parts of the colon). If this     therapeutic regimen demonstrates tolerability, a second larger study improving the     superiority of ciprofloxacin versus placebo can be initiated.   "
211303|NCT00609986|"     Purpose: The purpose of this study is to provide tight blood sugar control using insulin     given through the veins at the time of kidney transplantation and up to 3 days after surgery.     After release from the hospital, the patient will control blood sugar with subcutaneous     insulin injections or pills. With this approach, outcomes should improve for diabetic     transplant patients such as longer life of the new kidney, fewer hospital readmissions,     decreased associated infections, and other advantages.      Hypothesis: It is hypothesized that intensive glycemic control will lead to better clinical     and biochemical outcomes and improved long-term graft survival.   "
211304|NCT00609999|"     Primary:      To determine maximum tolerated dose & dose limiting toxicity of dasatinib when combined w     erlotinib among pts w recurrent MG      Secondary:      To further evaluate safety & tolerability of dasatinib + erlotinib To evaluate     pharmacokinetics of dasatinib when administered w erlotinib among recurrent MG pts who are on     & not on CYP-3A enzyme inducing anti-epileptic drugs To evaluate for anti-tumor activity with     this regimen in this patient population   "
211305|NCT00610012|"     The purpose of this registry is to record information of therapy reality of metastatic or     locally advanced Renal Cell Carcinoma by office-based medical oncologists in Germany.   "
211306|NCT00610025|"     During surgery for obesity, minimally invasive endoscopy can be performed and can assist the     surgeon in determining surgical incision sites.   "
211307|NCT00610038|"     The aim of our trial is to try to switch patients with permanent neonatal diabetes mellitus     due to a Kir6.2 or SUR1 activating mutation from subcutaneous insulin to oral glibenclamide     therapy.   "
211395|NCT00611182|"     This study has two aims:        1. To determine the relationship of shortness of breath (dyspnea) to other conditions          present in patients with pulmonary fibrosis.        2. To define the relationship between shortness of breath and rate of functional decline in          patients with pulmonary fibrosis.   "
211308|NCT00610051|"     This is a multicenter, double blind, placebo-controlled, randomized, parallel group study     that compares Alprostadil given in a low, fixed-dose continuous infusion and placebo. The     difference between the two groups for the primary endpoints will be compared after 24 weeks     (Outpatient Double-Blind Treatment Phase). Thereafter, patients will continue on blinded     treatment and observation to all continued assessment of survival and cardiac-specific     mortality (Follow-Up Phase). It is planned that approximately 550 patients with advanced     heart failure be randomized (see Inclusion and Exclusion Criteria   "
211309|NCT00610064|"     Sacral neuromodulation (SNM) has become an accepted treatment for patients with refractory     lower urinary tract dysfunction such as urgency frequency syndrome, urgency incontinence,     non-obstructive chronic urinary retention and chronic pelvic pain syndrome. Modulation of     central afferent activity is considered critical to this therapeutic effect but the neural     mechanisms are poorly understood.      We hypothesize that SNM has a significant effect on brain activity detectable by positron     emission tomography (PET).   "
211310|NCT00610077|"     OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients     with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group,     multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in     India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited.     Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles)     were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S):     Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.   "
211311|NCT00610090|"     The primary study objective, at this time, is to follow out to 5 years post implant the     safety of already enrolled subjects who were treated with the UniFit Aorto-uni-iliac (AUI)     Endoluminal Stent Graft (the study device) for the repair of abdominal aortic aneurysms     (AAAs).   "
211312|NCT00610103|"     The purpose of this study is to evaluate the efficacy of KW-6500 versus placebo when     administered as a subcutaneous injection at the individualized maintenance dose level in an     OFF state in Parkinson's disease patients with motor response complications on levodopa     therapy.   "
211313|NCT00610116|"     Evaluate appropriate performance of Electronic Repositioning™ (ER) in the clinical routine,     cumulative incidence of phrenic nerve stimulation (PNS) & success rates of ER to remove it,     various incl. left ventricular pacing (LVP) thresholds and PNS   "
211314|NCT00610129|"     The purpose of this study is to test a new drug for neuroendocrine tumors. We think that this     new drug may help control your tumor.      MK-0646 is a monoclonal antibody. An antibody is a protein that is able to attach to specific     target on cancer cells. This target helps the cancer cells grow and divide. By attaching to     the target, it may stop the cancer cells from further growth and dividing. This study will     help find out if MK-0646 is a helpful drug when taken in patients with neuroendocrine tumor.      This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects,     good and/or bad, MK-0646 has on metastatic neuroendocrine tumors.   "
211315|NCT00610142|"     to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on     unaffected forehead skin   "
211316|NCT00610155|"     This study is a methodology study designed to discover whether a brain imaging technology is     a better way of compare the relative sensitivities of fMRI and subjective psychometric     assessments of pain to multiple doses of pregabalin and tramadol SR in a cross-over clinical     study design.   "
211318|NCT00610181|"     The goal of this clinical research study is to learn how often magnetic resonance imaging     (MRI) of the breast locates additional areas of cancer in the breast of patients with lobular     cancer as well as in the breasts of young breast cancer patients (less than age 40 years).     Researchers also hope to learn how often the results of the MRI changes the type of surgical     treatment that is recommended and understand the costs associated with using MRI in the     diagnostic process. Researchers also want to use a different way of looking at the MRI scans     to learn if they can more easily learn the difference between a cyst and a tumor.   "
211319|NCT00610194|"     Primary Objective: To evaluate the safety of escalating oral doses of RDEA119, a MEK     inhibitor, in advanced cancer patients.      Secondary Objectives:        -  To describe the initial PK of different doses of RDEA119 when given once orally on Day 1          of the study        -  To describe the PK of different doses of RDEA119 when given orally as continuous dosing.        -  To examine the inhibition of MEK products (p-ERK), cytokine products, and other protein          biomarkers        -  To expand the MTD dose cohort to evaluate the safety, tolerability and PK/PD of the          recommended Phase 2 dose        -  To explore the presence of genotype, PD markers, cell growth and a marker of apoptosis,          in paired tumor biopsy samples of patients' tumors pre-dose and during dosing in a          minimum of 10 patients in the expanded cohort   "
211320|NCT00610207|"     Healing anal fistulas in Crohn's patients with an anal fistula plug.   "
211321|NCT00610220|"     The study will compare the effectiveness of a prefabricated wrist splint with thermoplast     reinforcements versus a short arm cast in skeletally immature children.      The hypothesis is that the commercially available wrist splint is at least as effective as     traditional casting with respect to recovery of physical function.   "
211322|NCT00610233|"     The precise mechanisms underlying cerebral regulation of lower urinary tract (LUT) function     are still poorly understood. Patients with deep brain stimulation (DBS) offer the unique     opportunity to investigate the role of different cerebral centers on LUT function.      We hypothesize that DBS has a significant effect on LUT function and that these effects     depend on the specific stimulated cerebral center.   "
211323|NCT00610246|"     The purpose of this study is to test the combination of radiation treatment and an     anti-angiogenic drug called sorafenib (or BAY 43-9006 or Nexavar) to determine the effects of     this combination on cancers but also on side effects of radiation treatment. This study will     also determine the highest safe dose of sorafenib that can be given with radiation treatment.   "
231821|NCT00887926|"     The purpose of this study is to determine if IMC-EB10 is safe for patients with leukemia, and     also to determine the best dose of IMC-EB10 to give to patients.   "
211325|NCT00610272|"     Bone metastasis is one of the most frequent end complications of the cancer. Radiation     therapy is the mainstay of treatment in this disease. Single fraction radiotherapy in both     single and multiple bone metastasis is widely used, but optimization of the single dose     fractionation is needed. Two different regimens of radiotherapy dose fractionation will be     investigated in both single and multiple bone metastasis and endpoints will include pain     relief as well as toxicity and quality of life.   "
211326|NCT00610285|"     Stereotactic radiosurgery (SRS) is a way to accurately treat brain tumors. SRS involves the     use of a special head frame to keep the head from moving during treatment. The head frame     makes very accurate treatment possible. The frame must be attached to the skull with special     pins. It feels very tight and can hurt. A special immobilization device can be used to keep     the head from moving.      This device does not need any pins and does not hurt. We would like to see if the new way of     holding the head still can be used for SRS. This is the purpose of the study. New X-Ray     machines can be used to find if the head has moved in the mask. We hope that we can use these     new tools to treat brain tumors just as accurately without using a head frame. It will make     treatment more comfortable for the patient. This is why we are asking patients to join the     study.   "
211327|NCT00610298|"     The aim of this study is to accumulate data about the influence of whole body vibration on     the functional recovery of adult patients with various neuromuscular and musculoskeletal     deficits requiring physical medicine and rehabilitation treatments.   "
211328|NCT00610311|"     Background:        -  gp100 is a protein that is often found in melanoma tumors.        -  An experimental procedure developed for treating patients with melanoma uses anti-gp100          cells designed to destroy their tumors. The anti-gp100 cells are created in the          laboratory using the patient's own tumor cells or blood cells.        -  The treatment procedure also uses a vaccine called plaque purified canarypox vector          (ALVAC) gp100, made from a virus that ordinarily infects canaries and is modified to          carry a copy of the gp100 gene. The virus cannot reproduce in mammals, so it cannot          cause disease in humans. When the vaccine is injected into a patient, it stimulates          cells in the immune system that may increase the efficiency of the anti gp 100 cells.      Objectives:      -To evaluate the safety and effectiveness of anti-gp100 cells and the ALVAC gp100 vaccine in     treating patients with advanced melanoma.      Eligibility:      -Patients with metastatic melanoma for whom standard treatments have not been effective.      Design:        -  Patients undergo scans, x-rays and other tests and leukapheresis to obtain white cells          for laboratory treatment.        -  Patients have 7 days of chemotherapy to prepare the immune system for receiving the          gp100 cells.        -  Patients receive the ALVAC vaccine, anti-gp100 cells and interleukin-2 (IL-2) (an          approved treatment for advanced melanoma). The anti gp100 cells are given as an infusion          through a vein. The vaccine is given as injections just before the infusion of gp100          cells and again 2 weeks later. IL-2 is given as a 15-minute infusion every 8 hours for          up to 5 days after the cell infusion for a maximum of 15 doses.        -  After hospital discharge, patients return to the clinic for periodic follow-up with a          physical examination, review of treatment side effects, laboratory tests and scans every          1 to 6 months.   "
211329|NCT00610324|"     Oropharyngeal bacteria play an important role in the pathogenesis of nosocomial pneumonia in     critically ill patients. Oral cleansing with chlorhexidine has been shown to decrease     incidence of pneumonia in patients undergoing open heart surgery. Its role in critically ill     general ICU patients is not yet proven. The present study proposes to study the effectiveness     of twice-daily oral cleansing with 0.2% chlorhexidine solution on the incidence of nosocomial     pneumonia in ICU patients admitted to a single intensive care unit of an Indian public     hospital   "
211330|NCT00610337|"     This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to be     conducted in North America and Europe and will include male and female subjects with acute     cervical SCI, 18 to 62 years of age, who receive clinical trial material (CTM) within 72     hours of injury.      This study is being undertaken to evaluate and confirm the safety and efficacy of CETHRIN®.     This adaptive study has been designed to efficiently identify the safest and most effective     dose in Phase IIb which will be evaluated in a future Phase III study. Given the current lack     of effective treatments for SCI, an improvement in motor ability or activities of daily     living in these subjects would be a great advancement in the treatment of SCI.   "
211334|NCT00610389|"     Background: cellular immunotherapy with dendritic cells (DC) loaded with tumor antigens has     shown clinical activity, although in a small number of patients. Therefore, is is mandatory     to improve the results of this strategy and to closely monitor immunologic response and cell     migration in order to improve our understanding of mechanisms of action and to settle future     fields of development..      Objectives: Primary: to confirm clinical activity of this strategy, determining tumor     response (RECIST criteria). Secondary: to determine: (1) safety; (2) antitumoral immune     response and (3) DC migration in the organism      Methodology: phase II trial in patients with advanced renal cell carcinoma and melanoma. We     will perform repeated immunizations with DC loaded with the patient´s tumor.   "
211335|NCT00610402|"     Sturge-Weber Syndrome (SWS) is a neurological disorder characterized at birth by seizures and     a large port-wine stain birthmark on the forehead and upper eyelid of one side of the face.     SWS is also accompanied by an increased pressure within the eye (glaucoma) which can develop     very early in life.      Glaucoma represents a group of ocular disorders that are characterized by the loss of retinal     ganglion cells and their axons, damage to the optic nerve, and gradual loss of visual field.     Recently, several studies provided evidence that there is a potential role of the immune     system in the pathogenesis of glaucoma.      These findings suggest that there might be changes in systemic humoral immunity possibly     underlying the optic neuropathy in at least some glaucoma patients.   "
211336|NCT00610415|"     To see if a limited sampling of tumor tissue from human subjects is a feasible way to gather     adequate tissue for cancer stem cell quantification.   "
211337|NCT00610428|"     Development of Staccato Prochlorperazine for the treatment of migraine headache.   "
211420|NCT00619151|"     The purpose of this study is to compare the sizing and implant techniques between the     CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.   "
231822|NCT00887939|"     Background:        -  Urticaria is a common itchy skin disorder that may occur spontaneously or on exposure to          a physical trigger (called physical urticaria).        -  Researchers are studying the genetic basis of a physically induced urticarial syndrome.          Once called familial cold urticaria, this condition is now called familial cold          autoinflammatory syndrome (FCAS). FCAS is an autoinflammatory disease, a group of          inherited disorders characterized by unprovoked episodes of inflammation. Patients with          FCAS often have hives, joint pain, and fever following general exposure to cold.        -  Patients with FCAS have a mutation in a gene that makes a protein called cryopyrin.          Cryopyrin seems to be involved with the production of a proinflammatory mediator called          interleukin-1 (IL-1). Patients with FCAS and others with autoinflammatory syndromes have          benefited from medication that blocks the effects of IL-1.      Objectives:        -  To investigate mechanisms that may cause physical hives or urticaria.        -  To reproduce urticaria through challenge testing (procedures to test the skin for a          reaction to a stimulus), followed by mast cell studies, measurement of IL-1, genetic          studies, and other molecular studies to lead to a better understanding of urticaria and          to design safe and more effective treatments.      Eligibility:        -  Patients between 6 months and 65 years of age with a documented history of clinically          reproducible physical urticaria that triggers hives and that has been evaluated by a          physician. Patients should have a letter of referral, including copies of pertinent          medical history and laboratory studies, from a referring physician.        -  Affected and nonaffected family members of such patients.        -  Exclusion criteria include (1) the presence of conditions that may put the subject at          undue risk, such as acute infection, severe thrombocytopenia (a lower than normal number          of platelets in the blood), or significant cardiovascular disease; (2) any condition          that would make the subject unsuitable for enrollment in this study; and (3) a history          of HIV, other known immunodeficiency, or evidence of chronic Hepatitis B and/or C          infection.      Design:        -  Researchers will conduct the following tests to verify which triggers cause the hives:             -  History and physical exam to determine the relationship between the trigger and               appearance of the hives.             -  Blood samples for baseline screening (additional samples may be taken within 8               hours of triggering hives).             -  Verification of hives using standard challenge testing.        -  Procedures to trigger urticaria (the challenge testing) include dermatographism          (stroking the skin), delayed pressure urticaria (direct pressure), cold-induced          urticaria (cold exposure), cholinergic urticaria (exercise, hot water), solar urticaria          (sun exposure), localized heat urticaria (direct heat exposure), aquagenic urticaria          (room temperature water), and vibratory angioedema (direct vibratory stimulus exposure).        -  Participants who have a positive history for hives and failed challenge testing (that          is, hives resulted from the triggers) will be asked to provide a skin biopsy and          additional bloods samples for research purposes.        -  Participants will be asked to return to the clinic within 1 month if multiple triggers          could not be verified during the initial visit, or to return for additional research          evaluations, which may include a skin punch biopsy and blood sample collection. Patients          may have to stay at the hospital overnight, if required to document the disease.        -  Nonaffected family members who enroll in this protocol will provide samples for          comparison with the family member who has a history of hives.        -  Participants will receive a small financial compensation for the skin biopsy.   "
211338|NCT00610441|"     This is a Phase 2 multicenter, randomized, double-blind trial of MK-8777 (Org 26576, SCH     900777) in adult subjects with Attention-Deficit/Hyperactivity Disorder (ADHD). MK-8777 or     placebo will be administered in a crossover fashion for two 3-week treatment periods. The two     3-week treatment periods will be separated by a 2-week placebo washout period.      The primary objective is to compare the efficacy of various doses of MK-8777 to that of     placebo in the treatment of ADHD symptoms in adults.   "
211339|NCT00610454|"     Subjects receiving LEV as adjunctive therapy to 1 or 2 other AEDs for partial onset seizures     and subjects who are temporarily unable to take oral LEV, may require alternative routes of     administration. The purpose of this trial was to evaluate the safety and tolerability of 1000     to 3000 mg/day LEV administered as a 15-min IV infusion b.i.d. after switching from the same     oral dose.   "
211340|NCT00610467|"     This study will investigate whether adding the optical imaging to magnetic resonance imaging     can improve the diagnostic specificity of breast cancer.   "
211341|NCT00610480|"     The goal of this research is to evaluate and compare the effectiveness of Systane® versus     Optive™ and Soothe™ on aqueous tear film stability in patients with a diagnosis of Dry Eye     Syndrome and to determine the possible application for this product in the future. Systane®     is marketed as over-the-counter tear lubricating therapy in the United States under the FDA     monograph.   "
211342|NCT00610493|"     The goal of this clinical research study is to find the highest tolerable dose of Avastin     (bevacizumab) and Torisel (temsirolimus) that can be given, in combination, to patients with     advanced cancer that has spread or is unable to be surgically removed. The safety of this     drug combination will also be studied.   "
211343|NCT00610506|"     Aims of Study:      The aims of this study are 1) to examine the clinical utility of escitalopram in patients     with major depression with atypical features; 2) to evaluate the tolerability of escitalopram     in major depression with atypical features.      Study hypothesis and objectives. This study is proposed as an open-label study to gather     pilot data to examine whether escitalopram has clinical utility in the treatment of major     depression with atypical features. Because of the exploratory nature of the design, no     specific study hypotheses can be generated regarding efficacy of the drug. Our primary     hypothesis is that the effect size of escitalopram in atypical depression will be similar to     the effect size of escitalopram in major depression, its FDA approved indication.   "
211344|NCT00610519|"     This randomized, double blind, parallel group study, compared the efficacy of spray     containing aromatic essential oils of some herbal plants, against placebo in the treatment of     patients with acute viral Pharyngo-tonsillitis.      Study objectives: Primary to demonstrate a throat pain relief within 20 minutes after first     administration of treatment with the spray.      Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and     signs comparing baseline therapy from the beginning to the end of 3 days treatment   "
211345|NCT00610532|"     The study is being done to understand why some patients with epilepsy (disease of recurrence     of seizures) do not respond very well to drug treatment with anticonvulsants.      Despite the availability of many anticonvulsants, about 30% of patients with epilepsy are     resistant to them. The cause of the resistance is not clear, but one of the reasons could be     an increased amount of proteins in the cells of the body called transporter proteins.      Transporter proteins are a group of proteins that help to defend the body against toxins,     including drugs, by pumping them out of the cells. Studies have shown that the number of     transporter proteins is higher in the parts of the brain that trigger seizures when compared     to other parts of the brain.      Studies in animals have shown that taking an anticonvulsant with an inhibitor (meaning to     stop or to reduce) of a transporter protein can increase the concentration of that     anticonvulsant inside the brain cells. The main purpose of the study is to determine if     taking an anticonvulsant and a transporter protein inhibitor will change the brain     concentration of the anticonvulsant.      In this study, a single dose of phenytoin (Dilantin® is a brand name anticonvulsant which has     phenytoin as its active ingredient), a commonly used anticonvulsant, will be given once by     itself, and then will be given a separate time with a single (i.e. one time only) dose of     probenecid. Probenecid, a medicine used commonly to treat gout (a disease of increased uric     acid), is known to be an inhibitor of transporter proteins. The study will use     electroencephalogram or EEG (recording of brain wave activities) to determine if the EEG     pattern when probenecid is given, will be different from the EEG pattern when phenytoin is     given alone. This will suggest that probenecid has affected the brain concentration of     phenytoin.   "
211346|NCT00610545|"     This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG     coA reductase inhibitor class of drugs referred to as statins, will reduce cardiovascular     outcomes ( mortality - myocardial infarction - stroke ) when given in high doses in     comparative standard doses in the perioperative period of major vascular surgery.      Abdominal aortic aneurysm , Carotid endarterectomy , Revascularization of lower limbs   "
211347|NCT00610558|"     This study will use MRI and PET scan to compare the brain imaging results between epilepsy     patients and normal healthy controls, also to study changes in 3 years.   "
211348|NCT00610571|"     Objectives:        -  To determine the maximum tolerated dose of oral topotecan when administered with Temodar          to patients with malignant glioma        -  To characterize any toxicity associated with the combination oral topotecan and Temodar.        -  To observe patients for clinical antitumor response when treated with oral topotecan and          Temodar.   "
211349|NCT00610584|"     Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there     is only limited evidence of its effectiveness. The aim of this three armed randomised     controlled multicentre trial is to investigate the efficacy of acupuncture plus rescue     medication vs. minimal (sham) acupuncture plus rescue medication vs. (b) rescue medication     alone in the treatment of seasonal allergic rhinitis.   "
211350|NCT00610597|"     Alcoholic liver disease is characterized by circulating T cell activation and liver T cell     infiltration but their phenotype is poorly studied. The aim of the study is to test the     hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in     alcoholic liver disease.   "
211365|NCT00610792|"     This a Phase 2, multicenter open label, uncontrolled 2-step design. Patients will be arranged     in two groups based upon the response to their last platinum containing therapy. The two     groups are, 1) Platinum Resistant Patients: patients with progressive disease while on     platinum containing therapy or stable disease after at least 4 cycles; patients relapsing     following an objective response while still receiving treatment; patients relapsing after an     objective response within 6 months from the discontinuation of the last chemotherapy and 2)     Platinum-Sensitive Patients: patients who relapsed following an objective response after 6     months from the discontinuation of platinum containing chemotherapy. All patients will     receive pyridoxine at least 200mg by mouth daily beginning approximately one week prior to     the initiation of the combination chemotherapy and it will continue up to the end of the last     treatment cycle.   "
211351|NCT00610610|"     Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with     fibromyalgia, information on the clinical implications of this comorbidity is limited. We     investigated whether a history of depressive and/or anxiety disorders was associated with     response to treatment in a double blind, randomized, placebo controlled trial of paroxetine     controlled release (CR) in fibromyalgia.      Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine     CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric     Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and     anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but     those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were     assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI);     subjects were excluded if they scored greater than 23 on the BDI. Health Status was     determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale     (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The     primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact     Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical     Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual     Analogue Scale for Pain (VAS) scores and number of tender points.   "
211352|NCT00610623|"     The purpose of this study is to assess the clinical efficacy of azithromycin, used as a     quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of     pneumonia in ventilated patients colonized with Pseudomonas aeruginosa.   "
211353|NCT00610636|"     The role of surgical resection in the subset of patients with resectable hepatic metastases     converted from initially non-resectable liver metastasis was still not clearly established.     To further explore the oncologic results of surgical versus non-surgical methods for the     treatment of this subset of patients, we designed and conducted the present randomized     prospective study beginning in 2002. The present study was based on the following arguments     against the predominant survival benefits of surgical resection in previous reported series:     (1) The initially non-resectable liver metastasis was basically a disseminated disease, even     though some metastases were highly responsive to chemotherapy and become resectable; (2)     Since the evaluation of resectability was based on the imaging studies, it was difficult to     consider the surgical resection as curative for the resectable hepatic metastases converted     from non-resectable ones, given the limitation of the current imaging stools of     high-technology; (3) The resectable hepatic metastases after neoadjuvant chemotherapy might     represent a subset of hepatic metastases biologically highly responsive to chemotherapy and     the time-to-progression for these metastases might be fairly long after a response.     Additionally, these metastases might be also biologically responsive to other cytotoxic or     targeted therapies that justified the patients' continuous adoption of non-surgical     treatment.   "
211354|NCT00610649|"     Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of     MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.   "
211355|NCT00610662|"     RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and     diagnose cervical intraepithelial neoplasia.      PURPOSE: This clinical trial is studying digital colposcopy to see how well it works in     finding cervical intraepithelial neoplasia in patients with an abnormal Pap smear.   "
211356|NCT00610675|"     This trial is a 52-week, open-label extension trial to investigate safety and to explore     efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706)     (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol     P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate     in Protocol 176004 (P05708) after signing informed consent.   "
211357|NCT00610688|"     The purpose of this research study is to compare the effects of higher dose vitamin D with     commonly recommended dose in pregnant women to see which is better in achieving and/or     maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well     as improving growth in the infant.   "
211358|NCT00610701|"     The purpose of this study is to evaluate patients with tibial plateau fractures.   "
211359|NCT00610714|"     The main purpose of this study is to determine if AZD0530 can improve the efficacy of     standard chemotherapy for the treatment of ovarian cancer   "
211360|NCT00610727|"     To evaluate the tolerability and safety of inhaled prochlorperazine To evaluate the     pharmacokinetics of inhaled prochlorperazine   "
211361|NCT00610740|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Using the CerviPrep™ drug delivery device to apply topical gemcitabine to the cervix may be     an effective way to kill more tumor cells.      PURPOSE: This phase II trial is studying how well CerviPrep™ works in applying topical     gemcitabine to the cervix in treating patients with primary endometrial cancer, cervical     cancer, or ovarian epithelial cancer.   "
211362|NCT00610753|"     This study will compare the effectiveness of two different family treatments for the     treatment of adolescent anorexia nervosa.   "
211363|NCT00610766|"     Estimation of radiation dose of coronary multislice computed tomography (MSCT) angiography in     daily practice in an international, multicenter and vendor-independent trial.   "
211364|NCT00610779|"     This randomized, double blind, parallel group study, compared the efficacy of spray     containing aromatic essential oils of some herbal plants, against placebo in the treatment of     patients with acute Rhino-sinusitis.      Study objectives: Primary to demonstrate a relief in the nasal obstruction within 20 minutes     after first administration of treatment with the spray.      Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and     signs comparing baseline therapy from the beginning to the end of 3 days treatment   "
211393|NCT00611156|"     The objective of this study is to examine whether four different spices (ginger, black     pepper, horseradish and mustard) are able to increase energy metabolism.      Since chili and other spices have been shown to increase energy expenditure compared to     placebo, we expect that some or all of the four spices may actually increase energy     expenditure - although not to a large degree.   "
211421|NCT00619164|"     The purpose of this study is to assess the safety and tolerability of E5555 in Japanese     patients with acute coronary syndrome.   "
211366|NCT00610805|"     We propose a feasibility study of aggressive CV risk factor management directed by preventive     cardiology compared to usual care. We will determine: 1) the efficacy of a preventive     cardiology program compared to usual care in slowing the progression of carotid IMT and     plaque, and 2) the effect of a preventive cardiology program versus usual care at achieving     CV risk factor target goals.      We hypothesize Lupus patients randomized to the preventive cardiology program will have less     cardiovascular progression over two years than those lupus patients who are given standard     care for cardiovascular risk, defined by carotid intima-media thickness and plaque.   "
211367|NCT00610818|"     We are approaching you to participate in this study because you are taking Palifermin and the     purpose of this study is to describe the effect of Palifermin on skin growth found on the     body. Palifermin is a new synthetic growth factor (encourages skin cells to grow)     specifically designed to protect the areas of the body (mouth and upper digestive tract) that     are damaged by chemotherapy. The cells in these areas are rapidly dividing cells and so are     killed by chemotherapeutic drugs. Palifermin is a drug that stimulates new cells in these     areas to grow and therefore protects patients from some serious side effects of chemotherapy.     These include mucositis or inflammation of the lining of the mouth and other organs resulting     in difficulty swallowing, speaking and extreme pain in the mouth and upper digestive tract.      Skin cells are also known to respond to these types of growth factors like Palifermin, but     unfortunately no studies have been done that look specifically at the effect of this drug on     pre-existing skin lesions or the development of new skin lesions. We will be asking you if     you have noticed any change in moles or other skin lesions that you have, and if you have     noticed any new lesions. We will also be doing a full physical examination of the skin at     regular intervals during the study to document the appearance of any new lesions or change in     pre-existing ones.   "
211368|NCT00610831|"     The objective of this study is to collect an image library of diagnostic digital mammograms     using the Carestream CR mammography system from patients who have histological-conformed     breast cancer to demonstrate the clinical feasibility of this system for detection of breast     cancer.   "
211369|NCT00610844|"     The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by     pathological correlation and to characterize the tissue response after treatment of primary     and secondary pulmonary tumors.   "
211370|NCT00610857|"     To determine the safety and efficacy of the combination of HDI and anti-CTLA-4 monoclonal     antibody for patients with recurrent inoperable stage III or stage IV melanoma.   "
211371|NCT00610870|"     The purpose of this study to determine whether statin pretreatment decrease myocardial     infarct size in patients with acute myocardial infarction undergoing primary percutaneous     coronary intervention.   "
211372|NCT00610883|"     Non-Hodgin's lymphoma is curable in 76% of patients. In nonlymphoblastic lymphmas, cancer may     return on average 3 months from beginning treatment and for lymphoblastic lymphomas, 6     months. To aggressively treat this cancer this study uses effective drugs in three parts:        -  Induction ends on day 19        -  Consolidation ends on day 38 or 42        -  Maintenance may include up to 6 cycles   "
211373|NCT00610896|"     This study is looking at cardiac rhythm management (CRM) and fusion beats in patients who     have a pacemaker or implantable cardioverter-defibrillator (ICD), to determine if there is a     correlation between the time between the contraction of the upper chambers of the heart     (atrium) and the lower chambers of the heart, (ventricle) and heart function.      Some studies of people with pacemakers have been done to determine if shortening the time of     contraction between the atrium and ventricle could benefit the function of the left     ventricle. These studies have shown that there is no benefit in heart function.There have     been other studies which have shown that chronic pacing of the right ventricle, especially     with the lead placed at the tip of the right ventricle, can lead to a decrease in the     function of the left ventricle and congestive heart failure. In some patients long term     pacing of the right ventricle has also been associated with a reduction in the ability of the     left ventricle to pump blood. This is know as a reduced left ventricular ejection fraction,     which can be documented by an echocardiogram.      This study proposes to evaluate the acute effects of progressive paced fusion beats on the     left ventricle to answer the question whether there is an delay between the atrium and     ventricle that is too long or too short.   "
211401|NCT00611273|"     Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing   "
211374|NCT00610909|"     Irritable bowel syndrome (IBS) is an extremely common disorder in the U.S population,     affecting somewhere between 9-22% based on community based studies. IBS has a chronic     relapsing course and overlaps with other functional gastrointestinal disorders. It accounts     for high direct medical expenses and indirect costs including a significant degree of     absenteeism. Most studies have suggested that there is a slight predominance among women,     especially those that have suffered some form of physical or sexual trauma. It has been     estimated that up to 25-40% of patients seen by gastroenterologists' are affected by IBS, and     that 70-90% of these patients may have a psychiatric comorbidity, most commonly major     depression and panic disorder, but also including schizophrenia, double depression, dysthymia     and alcohol abuse.      Abdominal pain and disturbance of bowel habits characterize the symptoms of IBS in the     absence of demonstrable structural pathology. The diagnosis of IBS relies upon clinical     criteria alone, as there is no gold standard in laboratory findings. The diagnosis is     dependent upon identifying characteristic symptoms, and then differentiating IBS from other     structural bowel disorders. Previously, the diagnosis of IBS was based upon a consortium     recommendation that examined and defined diagnostic criteria for over 100 functional     gastrointestinal disorders. These criteria became the most definitive in the area of     functional disorders and are referred to as the Rome Criteria. During the time since this     consensus, these criteria have been modified, and in 1999 became the foundation for the     second set of diagnostic criteria by consensus, now referred to as the Rome II criteria. The     revised Rome II criteria include only the first part of the original criteria, but now     require the presence of two out of three symptoms relating abdominal pain to bowel symptoms.      We designed our study and a Randomized, double-blind, parallel-group, flexible-dose,     placebo-controlled 12-week study.   "
211375|NCT00610922|"     To examine whether daily supplement of docosahexaenoic acid throughout the first year of life     may speed up the achievement of gross motor development milestones in healthy infants, a     total of 1160 healthy infants randomly allocated to receive throughout the first year of life     daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3     (400 IU) alone. Primary outcome measure: time of achieving gross motor development     milestones. Secondary outcome measure: time of achieving early fine motor development     milestones and language.   "
211376|NCT00610935|"     The purpose of this study is to determine the safety and effectivess of a single     intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated     influenza.   "
213348|NCT00645775|"     The study investigated the use and efficacy of the seeds of African bush mango (Irvingia     gabonensis)to control body weight, blood lipids and hormones in overweight and obese people.   "
211377|NCT00610948|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as panitumumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Giving everolimus together with combination     chemotherapy and/or panitumumab may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when     given together with fluorouracil, leucovorin, panitumumab, and oxaliplatin in treating     patients with solid tumors that did not respond to previous treatment.   "
211378|NCT00610961|"     The increase immunosuppression in our transplant population has led to an unacceptable rate     of patients at risk for BK virus nephropathy. Reducing induction immunosuppression by     switching from Thymoglobulin to Simulect will reduce the incidence of serum positivity for BK     by PCR.   "
211379|NCT00610974|"     The research proposed here will determine the effect of a novel treadmill gait training     strategy using a robotic gait trainer (the Lokomat) on functional ambulation in people with     SCI. The effect of the new therapy will be evaluated by analyzing changes in functional     ambulation and gait patterns during walking.   "
211380|NCT00610987|"     It has been established that providing antibiotic prophylaxis after closed fracture fixation     with implants or prosthetic devices has beneficial effects. However, the optimal duration of     antibiotic prophylaxis after orthopaedic trauma surgery is not well-defined. Most studies     comparing single-dose prophylaxis with multiple-dose prophylaxis have not shown beneficial     effects of additional doses. Our proposed study is intended to further define the appropriate     duration of antibiotic (cefazolin) administration for surgical prophylaxis in the treatment     of closed fractures. We will randomly assigned patients into two groups, hopefully     differentiated only by the duration of antibiotic administration (single dose vs. 24 hours).     We will follow these patients until fracture healing and determine if there is a difference     in the incidence of infection.   "
211381|NCT00611000|"     RATIONALE: Studying samples of blood and tissue from patients at risk of cancer in the     laboratory may help doctors learn more about the effect of folate on DNA and identify     biomarkers related to cancer.      PURPOSE: This phase I trial is studying the effect of folate on DNA in colon tissue and     peripheral blood samples from patients at increased risk of developing colorectal neoplasia.   "
211382|NCT00611013|"     Evaluating novel MR imaging techniques on volunteers.   "
211383|NCT00611026|"     To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo     for overactive bladder   "
211384|NCT00611039|"     Basing in studies which have related the darunavir (DRV) virtual inhibitory quotient (vIQ)     with the virological response, it is possible to think in the possibility of simplifying the     rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being     treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral     load, have a vIQ over 2. This strategy would not jeopardize the efficacy of the     antiretroviral treatment and would have less impact in the lipid profile of the patients as     well as less pharmaceutical expenditure.   "
211385|NCT00611052|"     The main purpose of this study is to assess the effect of a cognitive group intervention on     prevention of major depression in 14-15-year-old adolescents. Moreover, the effect on other     selected mental health parameters are investigated.   "
211386|NCT00611065|"     The goal is to develop MR imaging techniques to improve delineation of cancer extent, and to     improve differential diagnosis between prostate cancer and benign prostate hyperplasia or     other benign diseases.   "
211387|NCT00611078|"     The purpose of this study is to assess the feasibility of conducting a large hospital based     case control study of the role of dioxins and dioxinlike polychlorinated dibenzofurans     (PCDFs) and polychlorinated biphenyls (PCBs).   "
211431|NCT00619775|"     Evaluate the safety and efficacy of the Protege Stent and Spider Device in the treatment of     common and/or internal carotid artery stenoses for subjects that are high risk for carotid     endarterectomy.   "
211388|NCT00611091|"     The incidence of drug-induced injury is high in the ambulatory geriatric population and is     increased for elders upon transition from the hospital to the ambulatory setting. In this     application, we describe an effort to build on our extensive experience in medication safety     and HIT-based medication management to respond to the AHRQ RFA entitled Ambulatory Safety and     Quality Program: Improving Quality through Clinician Use of Health IT (RFA-HS-07-006). In     this study, we propose to develop and evaluate the value of an enhanced, HIT-based     transitional care intervention superimposed on the ambulatory electronic medical record (EMR)     to improve the quality and safety of medication management, focusing particularly on the     transition from the inpatient to the ambulatory setting for older adults with multiple     comorbid conditions who are prescribed high risk medications. We propose a randomized     controlled trial of a HIT-based transitional care intervention with enhanced medication and     therapeutic monitoring alerts to improve the quality and safety of patient monitoring and     medication management. We postulate that the efficient and coordinated delivery of actionable     health information to the clinician via use of HIT in the ambulatory setting can improve     medication safety for the growing geriatric population. The specific aims for this study are     to evaluate, among a population of older adults discharged from the hospital, the impact of     an enhanced discharge information system initiated upon transition to the ambulatory setting:     (1) on the rate of follow-up by an outpatient provider within 14 days of hospital discharge;     (2) on the prevalence of appropriate monitoring for selected high risk medications at 30 days     from the time of hospital discharge; (3) on the incidence of adverse drug events (ADEs) 30     days after discharge; and (4) on the rate of emergency department visits and hospital     readmission within 30 days of discharge. A secondary aim for this study is to determine costs     directly related to the development and installation of the HIT-based transitional care     intervention. This research allows for the examination of an integrated HIT intervention on     the quality of follow-up, outpatient clinician workflow, occurrence of ADEs, and health care     utilization to gain insights into the effective use of clinical alerts and coordinated     delivery of actionable information to outpatient clinicians in the management of ambulatory     elderly patients subsequent to hospital discharge.   "
211389|NCT00611104|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Studying samples of blood     and urine in the laboratory from participants receiving freeze-dried table grape powder may     help doctors understand the effect of this drug on blood estrogen levels.      PURPOSE: This clinical trial is studying the effect of freeze-dried table grape powder on     blood estrogen levels in postmenopausal women.   "
211390|NCT00611117|"     The study is designed to determine the effect of high physical activity level vs. low     physical activity level on the adaptation to a high fat diet.   "
211391|NCT00611130|"     The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated     subjects than placebo-treated subjects will be cocaine-free in the last 2 weeks of treatment.   "
211392|NCT00611143|"     The purpose of this study is to determine whether pretreatment with atorvastatin protects     against atrial fibrillation following off-pump coronary artery bypass graft surgery.   "
211394|NCT00611169|"     The purpose of this study to investigate whether the administration of high-dose tirofiban     before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced     magnetic resonance imaging.   "
211396|NCT00611195|"     To describe respiratory and laryngeal responses to laryngeal stimulation during propofol     anesthesia in children with upper airway infections. To determine whether the     co-administration of remifentanil blunts these reflex responses. To test whether the     co-administration of remifentanil results in a significant reduction of apnea with     laryngospasm in these patients.      Hypotheses:      I: In children with a URI undergoing anesthesia with propofol, the incidence of apnea and     laryngospasm after controlled stimulation is expected to occur 2.5 times more frequently than     in children without URI (20 vs. 8%).      II: The incidence of apnea and laryngospasm is diminished after administration of     remifentanil.   "
211397|NCT00611208|"     This is a Phase II clinical trial aimed at treating a subgroup of patients with cutaneous     T-cell lymphoma. The drug consists of a toxin, called diphtheria toxin, which is attached to     an antibody that can specifically target cancerous T-cells. Our primary objectives are,     therefore, to determine the patient subgroup with respect to disease burden who best responds     to this experimental drug in treating CD3 positive T cell malignancies. We will be     determining how the patient and their disease respond to this research agent.      The Clinical Response Data analysis from October 2014 done at the completion of the Phase I     portion of A-dmT390-bisFv(UCHT1) fusion protein clinical trial showed that there were 25     evaluable patients who received all 8 doses varying between 2.5 and 11.25 µg/kg per dose.     There were responses at all the lower dose levels up to 7.5 µg/kg per dose. The overall     response rate was 36% and the complete response rate was 16% (when followed for 6 months). We     have identified a subgroup of CTCL patients that have a very high response rate. If we     exclude patients whose mSWAT scores never exceeded 50 (50% of skin surface area times a     multiplier) and who never had lymph node involvement or stage III disease we are left with 9     patients. This subgroup has an overall response rate of 89% and a complete response rate of     50% (when followed for 6 months). Of these 4 patients currently in complete remission, three     are long-term responders. Two are over 6 years in duration and one over 5 years duration.     These may represent cures. The long time periods in the transition from partial response to     complete response without treatment, 6 months to two years, suggests that the study drug in     addition to exerting a direct killing effect on tumor also functions as an immunomodulator.   "
211398|NCT00611221|"     OBJECTIVE: To measure the benefits of massage, administered by a registered massage     therapist, to pain management for women in active labour.      DESIGN: A randomized controlled trial.      SETTING: BC Women's Hospital, a tertiary level maternity teaching hospital in Vancouver,     British Columbia, Canada.      PARTICIPANTS: Healthy first time mothers experiencing an uncomplicated pregnancy who present     to the hospital in labour. Seventy women will be enrolled in each trial arm.      MAIN OUTCOME MEASURES: The primary outcome is time to use of epidural analgesia measured as     cervical dilatation at the time of epidural insertion. Secondary outcomes include use of     epidural and narcotic analgesia, and measures of intensity and characteristics of pain.      DATA ANALYSIS: Study outcomes will be compared among women randomized to receive a maximum of     five hours of massage during labour administered by a registered massage therapist versus     usual care. Analysis will be by intention to treat. Prognostics factors not balanced between     trial arms (massage and usual care) will be controlled for in a multivariate analysis.   "
211399|NCT00611247|"     Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and     efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis   "
211400|NCT00611260|"     This is a trial to examine the effects of meditation on the incidence of ventricular     arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators.      We wish to test the following hypotheses:        1. Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in          patients with congestive heart failure.        2. Vipassana meditation improves the psychological profile in patients with CHF. In this          study, subjects meeting the inclusion and exclusion criteria will be recruited into the          study after obtaining informed consent. The subjects will then be randomized into either          an experimental group ( Meditation) or into a control group (usual care).   "
211402|NCT00618917|"     This is a Phase I-II study evaluating the feasibility, safety, and efficacy of swallowed     MnSOD plasmid/liposome (PL) transgene given as protection against radiation-induced     esophagitis during concurrent paclitaxel and carboplatin chemotherapy with thoracic radiation     in subjects with locally advanced non-small cell lung cancer (NSCLC).   "
211403|NCT00618930|"     The patients are assigned by randomisation on one of the two laxatives. After cleansing they     have to fill in an evaluation form to report their findings and difficulties. Also the     surgeon will be asked to fill in a score-form to report all details concerning the bowel     preparation.   "
211404|NCT00618943|"     This research aims to identify efficacious strategies for treating tobacco dependence among     adolescent smokers with co-occurring psychiatric disorders. Adolescent smoking remains a     significant public health issue with 23% of high school students reporting smoking a     cigarette in the past month1. Smoking rates are two to four times higher among adolescents     with psychiatric disorders such as attention deficit disorders, conduct disorder, depression,     anxiety disorders, and alcohol and illicit drug dependencies2-4.      Empirical investigations of adolescent tobacco treatment interventions number less than 50     with many of the studies criticized for methodological problems (i.e., follow up < 6 months,     poor retention, lack of control or comparison groups)2,5, 6. There have been no unequivocal     successes; however, promising interventions include stage-based, cognitive behavioral (CBT),     and multicomponent treatments2, 7. Additionally, the nicotine patch is well tolerated and     safe among adolescents8 and rarely abused9. Less than a third of adolescent tobacco users     report intention to quit in the near future2, 10, 11; thus, it seems critical that cessation     interventions for this complex group be designed to assist smokers at all stages of readiness     through the quitting process. A stepped care approach has the potential of matching more     intensive services to those ready for and in need of greater treatment. Interventions     delivered in health care settings have the appeal of broad reach.      The primary specific aims of this research are to evaluate, in a randomized clinical trial     (N=160), the efficacy of a stepped care intervention for treating smoking among adolescents     recruited from outpatient psychiatry settings. To our knowledge, this would be the first     study to examine outpatient psychiatry settings for treating tobacco dependence in     adolescents. The stepped care intervention combines expert-system contacts, individual CBT     sessions, and 12-weeks of nicotine replacement therapy (NRT).   "
211405|NCT00618956|"     The study is designed to accurately assess any changes in blood pressure and pulse at 100 and     200 mg daily dose of milnacipran in patients with fibromyalgia syndrome.   "
212081|NCT00619541|"     The purpose of this study is to use Sorafenib + 5-FU to evaluate activity, efficacy, safety,     pharmacodynamics (PD) and pharmacokinetics (PK) in patients with advanced hepatocellular     carcinoma (HCC).   "
211406|NCT00618969|"     The purpose of this study is to transplant haploidentical related peripheral blood stem cells     (PBSCs) that come from a relative such as a parent, sibling, a child or other relative who     has a half-matched tissue type with the recipient (rather than being completely matched)     following administration of a reduced-intensity regimen of busulfan, melphalan and     alemtuzumab.   "
211407|NCT00618982|"     Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of     advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib     works by stopping the development of new cancer cells and new blood vessels. By stopping the     growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth     of kidney cancer tumors.      This is an open-label study which means that the patient, the doctor and Bayer Healthcare     will know what tablets the patient is taking. All patients in this study will receive     sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day).     Treatment with sorafenib will continue until the patient's tumor grows larger or spreads     further or if the patient has intolerable side effects. The dose of sorafenib that the     patient will receive in the study will increase at certain points during the patient's     treatment, as long as the patient is not experiencing side effects and the patient's tumor     has not grown.   "
211408|NCT00618995|"     The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER     niacin, laropiprant, and placebo over the course of seven days on urinary levels of a     specific metabolite (which is a marker of in vivo platelet reactivity).   "
211409|NCT00619008|"     The purpose of this study is to test the hypothesis that a low-carbohydrate diet will impact     hormones and other factors that regulate appetite and energy balance, and result in lower     energy intake and greater weight loss, than a high complex carbohydrate diet.   "
211410|NCT00619021|"     RATIONALE: Bronchial artery infusion uses a catheter to deliver antitumor substances directly     to the lungs. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     tumor cells from dividing so they stop growing or die. Giving gemcitabine in different ways     may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given     by bronchial artery infusion and to see how well it works in treating patients with recurrent     or progressive non-small cell lung cancer.   "
211411|NCT00619034|"     The purpose of this study is to determine if diabetic retinopathy can be treated with     prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases     inhibitors.   "
211412|NCT00619047|"     Osteoporosis has been established as a major public health problem, primarily effecting     women. The attainment of maximal peak bone mass is crucial in the prevention of osteoporosis,     yet little is known about the specifics of bone accrual. Physical activity has been     identified as an important modifiable factor controlling bone accrual. It is has been shown     that increased activity during peri-pubertal years increase bone mineral content during     adulthood. Thus, strategies designed to increase peak bone mass should target the     peri-pubertal years of critical bone acquisition.      Hypothesis 1a: The amount of bone mineral accrued during the peri-pubertal years is greater     in girls who engage in impact activity than in those who do not.      Hypothesis 1b: The positive effects of impact activity on bone accrual are maintained after     cessation of the activity, resulting in greater bone mineral density in girls who participate     in impact activity during a portion of the peri-pubertal years than in those who never     participated in impact activity.   "
211413|NCT00619060|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of topical myristyl nicotinate cream may stop skin cancer from forming.      PURPOSE: This randomized phase I trial is studying the side effects and best way to give     topical myristyl nicotinate cream on the skin of healthy volunteers.   "
211414|NCT00619073|"     Clopidogrel is a medication that is used to decrease the ability of platelets to form blood     clots.      The theory has been proposed that, in patients with coronary artery disease or stroke,     increased platelet function after discontinuation of clopidogrel therapy is associated with     an increased clotting risk. However, this theory has never been rigorously tested.      The goal of this research is to determine whether discontinuation of clopidogrel results in     increased platelet function.   "
211415|NCT00619086|"     We evaluated the effects of giving a single dose of steroid before thyroid surgery in a     single institutional, double-blinded, randomized controlled trial. Postoperative nausea,     pain, and vocal function were significantly improved after steroid administration compared to     controls.   "
211416|NCT00619099|"     The purpose of this study is to determine the effectiveness and safety of two different dose     schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes     (MDS).   "
211417|NCT00619112|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients     with recurrent high-grade glioma.   "
211418|NCT00619125|"     Purpose: The associations between pain, stress, bloating, and their short interval temporal     relationships to defecation in IBS D, C & M are of great interest to the field of functional     GI disorders, but have not been adequately studied. Broad recall based assessments (i.e.,over     past week or month) of pain and bloating have been key features of the diagnosis of IBS,     however such long term retrospective recall of symptom experience has been shown to be     unreliable and influenced by outside factors (heuristics, recall bias, etc.). Short interval     assessment may provide a more accurate picture of patient symptom experience Participants:     Patients with IBS in general and IBS subtypes (IBS-C, D, M) Procedures (methods): Study     participants could be asked to record data at randomly assigned points throughout the day, as     well as during the course of a diarrheal or constipated stool (i.e., prior to and right after     a bowel movement).   "
211419|NCT00619138|"     The purpose of this study is to compare a stepped care model for the treatment of social     phobia and panic disorder with standard psychological treatment. The stepped care model     comprises three steps: short psycho-education, a 10 weeks Internet-based self-help program,     12 weeks individual cognitive-behavioural therapy. Patients are assessed at each step and     taken out of the study if they show significant clinical improvement and follow for 12     months. Patients are randomized to either the stepped care model or standard psychological     treatment, i.e. individual cognitive-behavioural therapy. All treatment components are     manualized.   "
211422|NCT00619177|"     The objective of the observational study is to examine the effect of MOVALIS (Meloxicam)     therapy on Health Related Quality of Life (HRQoL) in the diverse region of Central and     Eastern Europe. The Medical Outcomes Study 12 Item Short Form Health Survey version 2     (SF-12v2) will be used as the instrument to measure any change in physical wellbeing     (Physical Component Summary, PCS) and mental wellbeing (Mental Component Summary, MCS) of     patients following MOVALIS (Meloxicam) therapy.   "
211423|NCT00619190|"     The purpose of this open label study in children and adolescents is to examine the acute and     long-term effects of aripiprazole on problem behaviors associated with autism spectrum     disorders and development in areas which appear to be affected by autism spectrum disorders.   "
211424|NCT00619203|"     Bacterial meningitis remains a significant cause of morbidity and mortality in children,     especially in countries with limited resources. Efforts to improve the grim outcome have     included altering the first line antibiotic therapy, controlling seizures and managing fluids     more carefully. Adjuvant therapy of steroids has been used with limited success in children     in the West and with no proven value in Malawi and other resource constrained settings.     Glycerol has been used to reduce brain oedema in neurosurgery and it has recently been shown     to reduce morbidity in childhood meningitis in South America. Paracetamol in a high dosage     has been shown to reduce inflammation and cytokine levels in septicaemia with improved     outcomes in adults.      In Malawi the investigators have tried adjuvant steroids with no improvement in outcome of     childhood meningitis. They have recently concluded a study of ceftriaxone which has shown no     improvement in mortality though there is less hearing loss than with chloramphenicol and     benzyl penicillin.      Following the encouraging results of the Childhood South American Study it is important to     assess the use of adjuvant glycerol in children in the investigators' setting. Paracetamol is     routinely used in meningitis because of the accompanying fever and headache. This is an     opportunity to study its place as adjuvant therapy more carefully than has previously been     done.      The investigators propose a prospective, randomized, double blind 2 by 2 factorial designed     study to assess the advantage of ceftriaxone (antibiotic) given with paracetamol and glycerol     in combination, singly or with neither adjuvant therapy in childhood bacterial meningitis.   "
211425|NCT00619216|"     Liver transplant patients often require multimodal immunosuppressive therapy to minimize     their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower     the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up     to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of     patients have intolerance to MMF, thereby mitigating our ability to use this agent. The     primary objective of this study is to assess the tolerability of myfortic in combination with     Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after     conversion from MMF in maintenance liver transplant patients with GI intolerance within 3     months.   "
211426|NCT00619229|"     Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering     from dry age-related macula degeneration   "
211427|NCT00619242|"     To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe     is important in the progression of cancer.   "
211428|NCT00619736|"     This study will provide an initial assessment of the safety, tolerability and     pharmacokinetics (PK) of NSA-789 after administration of ascending single oral doses to     healthy Japanese male subjects. This is a randomized, double-blind, placebo-controlled,     inpatient, sequential-group study conducted under fasting conditions at a single     investigational site. Each subject will participate in only 1 dose group and will receive     only 1 dose of test article.   "
211429|NCT00619749|"     To determine whether fruit juice rich in polyphenols might increase exercise capacity and     memory in healthy sedentary subjects.Both parameters might be improved because of the     anti-oxidant effects of polyphenols.   "
211430|NCT00619762|"     This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM     product in three planned analyses. The primary objective of this study is to prospectively     assess the clinical outcomes associated with the use of LTM in two-stage (expander then     permanent implant) immediate post-mastectomy breast reconstruction.   "
211432|NCT00619788|"     This investigation is designed to demonstrate the efficacy and safety of the 4.0-5.0mm     AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use in a     controlled clinical investigation.      The scoring balloon is a semi-compliant balloon encircled by 3 spiral struts with a nitinol     scoring element, which theoretically provides targeted scoring of lesions, by concentrating     the dilation force thus minimizing barotrauma, elastic recoil and uncontrolled dissection.     This may improve the outcome of the intervention and reduce the number of stents required.   "
211433|NCT00619801|"     The purpose of this study is to determine the safety of the oral formulation of     levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis     or chronic urticaria of unknown origin.   "
211434|NCT00619814|"     The research protocol aim is to compare diagnostic tools for the proper evaluation of patient     with fecal occult blood test positive (FOBT +), a routine screening test for colorecatl     carcinoma. The purpose of this study is to determine if Double Contrast Barium Enema (DCBE),     a specialized radiographic exam of the colon, is a reasonable alternative for the evaluation     of patients with positive fecal occult blood as compared to colonoscopy, which is considered     the best evaluation method. Colonoscopy involves the direct visualization of the colon using     a flexible instrument. This permits the removal of polyps and to obtain biopsies. It involves     additional risks, discomfort and costs. In fact the DCBE is the experimental procedure in     this protocol.      Additional aims of this study are: to determine the localization, number, size and pathologic     characteristics, if applicable, of findings in colonoscopy and/or DCBE and to determine the     patient preference between both studies.      This study is limited to those patients 50 years or older who are at average risk for colon     cancer and who had a positive fecal occult blood screening test.   "
212082|NCT00619554|"     This study is designed to create an instruction set simple enough to be understood by     migraine subjects as they were experiencing miagraine attacks.   "
211435|NCT00619827|"     The objective of this study is to assess the effect of grass pollen extract SLIT tablets on     the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in     response to grass pollen challenge after one week, one, two and four months of treatment in     patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.   "
211436|NCT00619840|"     Investigation of efficacy and tolerability of extended-release MPD in adults with ADHD,     compared with a placebo, and to acquire knowledge through long-term observation of adults   "
211437|NCT00619853|"     The purpose of this pilot study was to compare unimanual training (CIMT) and bimanual     training (HABIT) protocols aimed to improve ability of the involved hand in children with     hemiplegia. Both protocols were conducted in an educational setting for 2 hours a day for 2     months, one-hour group session and one-hour individual therapy session conducted by     occupational therapists or assistants.      The children in the CIMT group practiced various tasks using their involved hand with the     contralateral hand constrained with a mitt. The children at the HABIT group practiced various     bimanual tasks without constraint.      Twelve children (2 - 6.5 yrs.) participated in this study. The inclusion criterion included     minimal extension movement of the involved wrist, and for the CIMT group, the ability to of     tolerates the mitt. The children were matched in relation to cognitive level and MACS score     and randomly divided into the two intervention groups.      Each child's assessment included the Quality of Upper Extremity Skills Test (QUEST), the     Assisting Hand Assessment (AHA), and the Blocks and Box for children above age 5 yrs old.     Range of motion (ROM) was assessed using an electronic gonimeter, and muscle tone was     recorded using surface EMG and the Tardiue scale. The Child Health Questioner (CHQ) was     completed by the parents before, and 6 months after, the intervention. Children were assessed     starting two month before, and two month after, the intervention.   "
211438|NCT00619866|"     This study is designed to see how a research compound (NBI- 56418) works compared to placebo     (also known as a sugar pill) in women with endometriosis and to see the effect, if any, on     bone mineral density.   "
211439|NCT00619879|"     The purpose of this study is to show that myeloablative hematopoietic progenitor cell     transplantation (HPCT) continues to offer acceptable disease-free survival for select     patients requiring HPCT.   "
211440|NCT00619892|"     The primary objective of this study is to test the hypothesis that a SSRI plus quetiapine SR     (Seroquel SR) will result in superior early (first 1-3 weeks of treatment) stabilization of     panic symptoms in SSRI-resistant, comorbid Panic Disorder patients versus a SSRI plus     placebo.   "
211441|NCT00619905|"     This study assessed the long-term safety and tolerability of ACZ885 in patients with     rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or     improvement of joint structure and bone mineral density, and long term maintenance of     health-related quality of life.   "
211442|NCT00619918|"     This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of     viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease     rate of hospital admission, decrease clinical severity scores, and decrease length of stay.   "
211443|NCT00619931|"     The APD791-002 study is designed primarily to evaluate the safety, tolerability, and     pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.   "
211455|NCT00620087|"     We aim to determine if Molecular Breast Imaging (a new nuclear medicine technique developed     at Mayo) can identify malignant breast lesions in women who have atypical ductal hyperplasia,     atypical lobular hyperplasia, or lobular carcinoma in situ.   "
211456|NCT00620100|"     To determine the Objective Response Rate of 4 cycles of docetaxel + anthracycline (epirubicin     or doxorubicine) followed by 4 cycles of docetaxel single agent. To determine the Time to     Tumor Progression (TTP), the Response Duration, the Overall Survival. To confirm the safety     profile   "
211507|NCT00620763|"     The impact of protein sources such as beef as part of Western diet on calcium retention     remains controversial. We propose to test the hypothesis that the positive effect of high     protein intake (especially from meat protein) can offset the negative effect of     protein-induced net acid load on bone metabolism and the retention of body calcium. Healthy     postmenopausal women recruited from the community will consume two diets differing in meat     protein and acid load for 7 weeks. Calcium retention from diets will be determined using a     highly sensitive measurement of whole body retention of a calcium isotope added to the diet.   "
211444|NCT00619944|"     With the roll out of antiretroviral therapy (ARV) for HIV across sub-Saharan Africa an     unprecedented number of people will be commencing lifelong therapy. Current estimates are     that 5-6 million people in sub-Saharan Africa require ART. At the same time, the World Health     Organization (WHO) Roll Back Malaria campaign is aggressively promoting the use of     artemether/lumefantrine as first-line therapy for malaria in this setting. Many patients in     this setting have already become resistant to first-line ARV and have moved onto     lopinavir/ritonavir (Kaletra) based second-line regimens. Kaletra is a potent inhibitor of     Cytochrome P450 3A4 (CYP 3A4), an enzyme responsible for the metabolism of many drugs which     is found predominantly in the liver and the gut. Lumefantrine, and to a lesser extent     artemether, is extensively metabolized by CYP 3A4. Therefore when given to a patient already     taking Kaletra for HIV, it is likely that elevated levels of these drugs in the patient will     result. There is some concern that lumefantrine may be cardiotoxic due to its structural     similarity to halofantrine which is known to cause irregular heart rhythms. This has not been     borne out as yet in any studies performed with lumefantrine, however it is not known what     levels will be achieved in patients when it is administered with a protease inhibitor such as     Kaletra. The WHO has not addressed this issue in any of its previous policy documents but has     identified ARV-antimalarial drug interaction studies as a research priority. This single dose     pharmacokinetic (PK) study aims to compare the levels of lumefantrine/artemether that result     when it is given to a patient on Kaletra with patients not on any ARV. Data generated by this     study will help address this important knowledge gap which has been identified by WHO and     others as meriting urgent investigation.   "
211445|NCT00619957|"     Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men     with osteoporosis followed by a two year follow-up study.   "
211462|NCT00620178|"     This study is a Swedish historical cohort study in patients prescribed Atacand or Cozaar for     hypertension by selected primary care centres. Data will be extracted anonymously from     electronic medical records. In addition, data regarding morbidity and mortality will be     collected by merging the cohort with the following national registries: the Hospital     Discharge Register (Slutenvårdsregistret), the Cause of Death Register and the Heart     Intensive Care Admission (RIKS-HIA)   "
211478|NCT00620386|"     We studied intubating conditions and hemodynamic changes during endotracheal intubation     employing either Bonfils intubating fiberscope or the conventional Macintosh laryngoscopy in     80 healthy patients candidates for elective surgery requiring endotracheal intubation. We     omitted neuromuscular blocking drugs from the induction regimen.   "
211479|NCT00620399|"     This study evaluated the hypothesis that bracing following lumbar spinal fusion surgery     improves functional outcome following surgery   "
211537|NCT00621166|"     To determine the pharmacokinetic profile of generic lopinavir/ritonavir tablets To     investigate the possible influence of pregnancy and duration of pregnancy To determine the     antiviral activity and safety of generic lopinavir/ritonavir® Compare pharmacokinetics     parameters before and after pregnancy.   "
211446|NCT00619970|"     Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in     adults, it is one of the functional bowel disorders without a clear framework of     understanding or an effective treatment. However, new research suggests that small intestinal     bacterial overgrowth (SIBO) may be the unifying pathophysiology that explains the variety of     symptoms experienced by patients with IBS. As CAP in children is believed to be a precursor     to IBS in adults, we hypothesize that children with this disorder have a significantly     greater prevalence of small intestinal bacterial overgrowth (SIBO) than normal, healthy     children, and that eradication of bacterial overgrowth with antibiotics will reduce symptoms     of chronic abdominal pain in children with this condition. To prove this, we will first aim     to determine the prevalence of SIBO in both healthy children and those with CAP. We will do     this by performing a lactulose breath hydrogen test, the gold standard for the noninvasive     measurement of SIBO, on 40 healthy controls and 80 subjects with CAP. We will then assess     whether eradication of SIBO with antibiotics will reduce symptoms of chronic abdominal pain     in children with this condition. To do this we will randomize, in a double-blinded fashion,     the 80 CAP patients to receive a 10-day course of either the antibiotic Rifaximin or a     placebo. After completion of the treatment we will evaluate all these patients for     eradication of bacterial overgrowth by repeating a lactulose breath hydrogen test. We will     also assess for symptom improvement by re-administering questionnaires.   "
211447|NCT00619983|"     The purpose of the study is to determine whether the combination of the the three drugs     gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic     neuropathy or patients with failed low back syndrome (chronic back pain).   "
211448|NCT00619996|"     The purpose of this study is to use Sorafenib plus Docetaxel to evaluate pharmacodynamics     (PD) in Patients with prostate cancer.   "
211449|NCT00620009|"     The purpose of the research is to: 1) to test whether psychotherapy including immediate     feedback of empathy data is more efficacious than therapy without such an exchange of data,     2) to measure the degree of accuracy of therapist's empathy and its relationship to the     patient's estimate of the therapist's empathy.   "
211450|NCT00620022|"     This study compared the effect of indacaterol (300 μg once daily [od]) on exercise endurance     with that of placebo in patients with moderate to severe chronic obstructive pulmonary     disease.   "
211451|NCT00620035|"     The primary purpose of this study is to evaluate the use of the next generation applicator     and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives     include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and     safety of the Radiopaque Implant, assessment of x -ray visibility of the Radiopaque Implant,     and to assess participant expectations and satisfaction with the Radiopaque Implant.   "
211452|NCT00620048|"     The purpose of this study is to determine if cell therapy with your own cells (autologous     cells) delivered with a catheter to regions of the heart with poor blood flow will be safe     and if it will improve your ejection fraction and heart failure symptoms.   "
211453|NCT00620061|"     The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone     administration in patients with OBD.   "
211454|NCT00620074|"     This study will test the effectiveness and the safety of giving two antifungal agents     (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are     unable to tolerate polyene therapy.   "
211457|NCT00620113|"     The purpose of this study is to assess the dose-response on the percent change from baseline     in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when     odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52     weeks to Japanese involutional osteoporosis participants. The study will also assess safety     and tolerability of odanacatib (10, 25, and 50 mg) in these participants.      The study will enroll approximately 280 participants and randomly assign them to 3 different     doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium     carbonate. The primary efficacy hypothesis is that a dose-response relationship on the     percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50     mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis     participants. The primary safety hypothesis is that odanacatib will be safe and well     tolerated over 52 weeks to involutional osteoporosis participants.   "
211458|NCT00620126|"     The purpose of this study is to determine if home automated telemanagement improves bowel     symptoms, quality of life, compliance with medications, and health care utilization compared     to best available care in patients with ulcerative colitis.   "
211459|NCT00620139|"     This pilot study seeks to evaluate the feasibility of measuring the proximal effects of     concurrent chemoradiotherapy (CRT) on the expression of potential therapeutic target     molecules in Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, this study proposes     to evaluate the extent to which CRT induces the differential expression of components along     two critical, and potentially interdependent, molecular pathways: the arachidonic acid and     epidermal growth factor receptor (EGFR) signaling pathways.   "
211460|NCT00620152|"     In this study, we evaluate whether dietary advice based on two healthy nutritional programs     can be effectively delivered to families over one month by telephone. We hypothesize that     among overweight school age children, a one-month telephone intervention will result in     specific dietary changes consistent with the randomly assigned dietary intervention.   "
211461|NCT00620165|"     Essential tremor poses one of the greatest therapeutic challenges to neurologists. This study     will examine the effectiveness of the drug, levetiracetam or keppra, for the treatment of     essential tremor.   "
211514|NCT00620854|"     This study compares the performance of different doses of oral recombinant salmon calcitonin     (rsCT).   "
211515|NCT00620867|"     To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with     osteoarthritis (OA) of the knee.   "
211463|NCT00620191|"     Hyperinsulinemia and type 2 diabetes (T2D) are important potential risk factors for cognitive     decline and Alzheimer's disease (AD). Two thirds of the US adult population are at risk for     hyperinsulinemia and T2D, and half of the population 85 years and older have AD. Peripheral     hyperinsulinemia can impair the clearance of amyloid beta in the brain, the main culprit in     AD. Thus, we hypothesize the lowering peripheral insulin in overweight persons with amnestic     mild cognitive impairment (AMCI), a transition state between normal cognition and AD, can     decrease the risk of cognitive decline and progression to AD. We propose to conduct a phase     II double blinded placebo controlled randomized clinical trial of metformin, a safe and     effective medication that prevents hyperinsulinemia and diabetes, to test this hypothesis     among 80 overweight persons aged 55 to 90 years with AMCI. The main outcome of the study will     be changes in performance in a memory test (total recall of the Selective Reminding Test) and     the Score a test of general cognitive function used in clinical trials (the Alzheimer's     Disease Assessment Scale-cognitive subscale-ADAS-Cog). . Another aim is to compare brain     function in an area affected by Alzheimer's disease between the metformin and placebo group     mean changes from beginning to end among 40 participants using a PET scan.   "
211464|NCT00620204|"     The objective of this study is to evaluate effect of statin treatment for vasospastic angina.   "
211465|NCT00620217|"     Achieving therapeutic angiogenesis with gene therapy using a plasmid coding human     VEGF-A165/bFGF injected into ischemic myocardium of refractory coronary artery disease     patients, employing a percutaneous catheter-based technique- a double-blind placebo     controlled study.      Some patients with persistent coronary artery disease cannot be effectively treated using     methods available today (no-option patients). It is currently evident that an emerging     therapy for them might be the stimulation of neoangiogenesis in the area of ischemic     myocardium using growth factor genes. Agents attracting greatest interest are FGF (fibroblast     growth factor) and VEGF (vascular-endothelial growth factor). A number of methods have been     tested to deliver these agents to the area of interest.      Basic research has revealed that potent forms of angiogenic growth factors are the basic FGF     (bFGF) and VEGF type A. Most clinical research on therapeutic angiogenesis is done using one     of these two growth factors. This is to our knowledge the first clinical study using     bicistronic VEGF-A 165/bFGF plasmid.      Patient population will comprise CCS III and CCS IV coronary artery disease patients who     cannot be treated with standard revascularization methods. In the course of study we shall     attempt to analyze the efficacy of therapeutic plasmid-induced angiogenesis in terms of     myocardial perfusion increase and clinical symptom improvement. The feasibility and safety of     plasmid delivery method will also be assessed. A percutaneous catheter-based technique     (Myo-Star, Johnson & Johnson®) is used for plasmid delivery.      All patients enrolled will receive optimal medical treatment as judged by treating physician.     An effort will be made to modify medical therapy during the study course only for clear     reasons.      Standard angiography and ventriculography will be performed prior to plasmid injection     therapy. Ischemic area of interest will be identified on inclusion by SPECT. Cardiac nuclear     magnetic resonance (cNMR) with adenosine will also be performed to assess heart morphology,     function and perfusion. Next, injections will be performed according to protocol.      Follow-up visits will be performed at month 4 and month 12 after injection therapy.      A change in myocardial perfusion at rest and on dipyridamole-stress SPECT evaluation after     injection therapy will be the primary measure of efficacy. Changes in exercise tolerance will     also be monitored along with a number of other efficacy and safety parameters.   "
211466|NCT00620230|"     This study will evaluate the safety and tolerability of single and multiple doses of VAK694     in healthy volunteers and otherwise healthy volunteers with a history of allergies.   "
211467|NCT00620243|"     We hypothesize that 18FDG Positron Emission Tomography (FDG PET) imaging, carried out after     the first cycle of chemotherapy, will identify responders, thus permitting early termination     of potential toxic therapy in non- responders leading to a significant decrease in morbidity     and cost. The value of PET imaging as an early predictor of response to chemotherapy has been     shown in other cancers.   "
211468|NCT00620256|"     The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy     of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all     dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular     hypertension.   "
211618|NCT00607789|"     The purpose of this research study is to test the safety of duloxetine and see what effects     (good and bad) it has on the subject's binge eating disorder and comorbid depressive disorder     (depression occurring with binge eating disorder) compared to placebo (inactive pill).   "
211469|NCT00620269|"     The use of induction chemotherapy is feasible and effective. It is also logistically     beneficial for decreasing micrometastases and radiation-related toxicity by decreasing tumor     burden before definite locoregional concurrent therapy. Previously the investigators     conducted several phase II study of IP chemotherapy in advanced NSCLC and demonstrated that     IP chemotherapy has a promising activity and readily manageable toxicity profile. Given the     encouraging activity of IP chemotherapy in the advanced stage setting, the investigators     postulated that their further investigation in the stage III setting might lead to further     prolongation of survival times. In addition to cisplatin, Irinotecan has been demonstrated to     act as radiation sensitizers in preclinical and clinical setting. Therefore, their use with     concurrent radiotherapy might lead to radiation sensitization and improved locoregional     control.   "
211470|NCT00620282|"     This trial is conducted in the United States of America (USA). The purpose of the trial is to     assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who     are on diet and lifestyle changes or treated with metformin alone.   "
211471|NCT00620295|"     RATIONALE: Bortezomib may stop the growth of solid tumors by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as gemcitabine, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving bortezomib together with     gemcitabine may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and     gemcitabine in treating older patients with advanced solid tumors.   "
211472|NCT00620308|"     This human physiologic study will evaluate the effects of a new drug called CD-NP in     individuals with stable chronic heart failure, with a focus on evaluating responses of the     kidneys and the hormonal system.   "
211473|NCT00620321|"     The purpose of this study is to understand the safety profile of LY2181308 sodium     administered in combination with idarubicin and cytarabine to patients with relapsed or     refractory AML.   "
211474|NCT00620334|"     Despite the development of effective medications for treatment, asthma remains a significant     contributor of morbidity, mortality, and financial hardship to patients with the disease. An     estimated 300 million people worldwide have asthma, making it one of the most common chronic     diseases in the world. Asthma accounts for 250,000 deaths per year worldwide, and 1.7 million     emergency room visits per year in the United States. Cost of asthma in the United States was     an estimated $12.7 billion dollars per year in 1998, and the prevalence is increasing. In     2002, there were 13.9 million outpatient asthma visits to private physician offices and     hospital outpatient departments, and 484,000 asthma hospitalizations. Children 5-17 years of     age missed 14.7 million school days, and adults missed 11.8 million work days due to asthma     in 2002.      There is no single diagnostic test or symptom that defines asthma. Asthma is a syndrome     consisting of a constellation of symptoms that include wheeze, cough, shortness of breath,     and chest tightness. The diagnosis of asthma takes into account history, physical examination     findings, and objective measures of pulmonary function and markers of inflammation. In many     cases the diagnosis is not in question, allowing for early recognition and appropriate     treatment. In other cases, confounding factors makes the diagnosis both challenging and time     consuming for the physician and the patient. According to the National Asthma Education and     Prevention Program Expert Panel Report 2, asthma is defined as:      a chronic inflammatory disorder of the airways in which many cells and cellular elements     play a role, in particular, mast cells, eosinophils, T lymphocytes, macrophages, neutrophils,     and epithelial cells. In susceptible individuals, this inflammation causes recurrent episodes     of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the     early morning. These episodes are usually associated with widespread but variable airflow     obstruction that is often reversible either spontaneously or with treatment. The inflammation     also causes an associated increase in the existing bronchial hyperresponsiveness to a variety     of stimuli.      Airway obstruction and reversibility is measured by pulmonary function testing before and     after inhalation of a short acting beta agonist. Airway hyperresponsiveness is measured by     methacholine challenge.      Estimates of asthma prevalence are generated by the use of written questionnaires in     epidemiologic studies. , One of the difficulties with reliance on questionnaires is that     patients often misinterpret the questions or fail to answer the question altogether. In this     study, a physician will review the questionnaire with the patient in order to clarify each     question.      The goal in this study is to evaluate a simplified set of questions that can be easily     implemented into clinical practice that will predict the presence or absence of asthma.      Hypothesis      A simplified questionnaire will predict asthma in adults.      Study Objectives      § Primary Objective      o To evaluate the predictive value of a questionnaire designed to diagnose asthma in adults   "
211475|NCT00620347|"     the investigators will conduct a phase II trial to evaluate the efficacy and toxicity of     Sunitinib in patients with recurrent SCLC.   "
211476|NCT00620360|"     It has been widely documented that fructose overfeeding increases plasma triglycerides and     hepatic de novo lipogenesis, and impairs insulin sensitivity in healthy male volunteers. The     effect of gender on the metabolic responses to fructose remains an important open question,     however.      The objective of this study is to compare the effect of an acute oral fructose load on     carbohydrate and lipid metabolism in healthy young males and females.   "
211477|NCT00620373|"     We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast     Imaging (a new gamma-camera based breast imaging technology) in women with dense breast     tissue who are at increased risk for breast cancer.   "
211480|NCT00620412|"     The purpose of this study is to determine whether the food supplement called Lactobacillus     rhamnosus GG (LGG) may help boost the effectiveness of the nasal flu vaccine. Preliminary     data from several studies of healthy volunteers suggest that LGG boosts the immune response     to vaccines. Fifty-two subjects will be recruited into the study, all will receive the nasal     flu vaccine. Twenty-six will receive capsules that contain LGG, 26 will receive placebo     capsules. Blood and nasal specimens will be collected weekly for four weeks and at eight     weeks to evaluate the initial mucosal and systemic immune response to the immunization. This     study will provide preliminary data on whether the immune response of healthy adults to the     nasal influenza vaccine can be boosted by LGG.   "
211481|NCT00620425|"     Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled     with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over     2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.   "
211482|NCT00620438|"     There are increasing numbers of HIV-infected patients in sub-Saharan Africa receiving     antiretroviral drugs and/or rifampicin based antituberculous therapy. HIV infected patients     are at an increased risk of contracting malaria. Increasing resistance to anti-malarials such     as chloroquine, amodiaquine, fansidar, sulphadoxine-pyrimethamine in East and West Africa has     led the WHO to recommend artemether-lumefantrine (Coartem®- Novartis) as first line therapy     for malaria for adults and children. As early as 2004, fourteen countries in sub-Saharan     Africa had adopted this guideline as national policy.      There are no data on the interaction between Coartem® and any of the antiretroviral agents.     Both components of Coartem® are substrates for the 3A4 isoform of cytochrome P450. Despite     the lack of data, antiretroviral drugs and/or antituberculous drugs in addition to Coartem®     are of necessity co-prescribed daily in the African setting. Nevirapine, efavirenz and     rifampicin are known inducers of cytochrome P450 3A4. A technical consultation convened by     WHO in June, 2004 concluded that additional research on interactions between antiretroviral     and antimalarial drugs is urgently needed.      We propose to perform a suite of pharmacokinetic studies to evaluate these interactions in     HIV infected Ugandan patients. The aim of these studies is to evaluate the pharmacokinetic     interaction between Coartem® and commonly co-prescribed inducers of 3A4 i.e. nevirapine,     efavirenz and rifampicin.        1. Comparison of steady state pharmacokinetics of Coartem® in HIV-infected patients prior          to commencement of nevirapine and at nevirapine steady state        2. Comparison of steady state pharmacokinetics of Coartem® in HIV-infected patients prior          to commencement of efavirenz and at efavirenz steady state        3. Comparison of steady state pharmacokinetics of Coartem® in Ugandan patients at          rifampicin steady state and without rifampicin   "
211483|NCT00620451|"     The purpose of this research study is to look at how effective and safe larazotide acetate     (AT-1001) is when it is given to subjects who have active Celiac Disease. A leaky gut is     often found in Celiac Disease patients, and it is thought that the leakiness contributes to     the disease, possibly by letting more gluten enter the body. Larazotide acetate (AT-100l) is     an experimental drug that may possibly reduce gut leakiness and is being investigated to see     if it can help people with Celiac disease along with a gluten free diet.   "
211484|NCT00620464|"     The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and     Radiopaque IMPLANON.   "
211506|NCT00620750|"     Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The     efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has     been demonstrated in clinical trials, raising the prospect of integrating pharmacologic     treatment for alcohol dependence into general medical care settings. However, the feasibility     of implementing this United States Food and Drug Administration approved treatment in the     front-line settings in which it is most needed has not been demonstrated. This is an     open-label pilot feasibility study of implementing treatment with Vivitrol in primary care     medical clinics in a safety net hospital system affiliated with an urban academic center.   "
211619|NCT00607802|"     RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with     cancer.      PURPOSE: This clinical trial is studying the side effects of donor white blood cell infusion     in treating patients with metastatic or unresectable cancer.   "
211485|NCT00620477|"     Patients who suffered from a rupture of the Anterior Cruciate Ligament with instability of     the knee joint, will be treated with an operative ACL-reconstruction. One group of patients     will stay one night in the hospital and go home the other day (Group I). The other group of     patients will go home the same day of surgery (Group II). All patients will undergo the same     arthroscopic reconstruction of the ACL. Anesthesia will be performed on each patient in a     classic manner. At the end of the surgery each group of patients will be randomly divided in     two subgroups: one group will get an injection in the knee joint with 20 ml of physiological     fluid (Group Ia en IIa), the other group will get an injection in the knee joint with 20 ml     of chirocaine 0.125%, a widely used pain-medicine (Group Ib and IIb). This will happen in a     double blind, randomized way. The whole procedure takes about one hour. After surgery     patients are brought to the recovery room and are observed every 30 minutes for the duration     of 4 hours. Before being brought to their rooms, patients will have to fill in a VAS: Visual     Analogue Scale, to determine their pain. After being brought to their rooms, the patients     will have the choice of going home the same day or staying in the hospital for one night,     according to the amount of pain they are in. That moment it will be possible to switch     groups. Patients who go home the same day of surgery will be contacted by phone the day after     to fill in a question form. Patients who were admitted for one night will be seen before     their leave to fill in the same question form.   "
211486|NCT00620490|"     osteolateral thoracotomy is a painful surgical procedure.Thoracic epidural analgesia (TEA) is     usually considered as the gold standard for postoperative thoracic analgesia.     Unfortunately, it's not always possible to realize it because of contraindications or because     of technical failures.Analgesia using a paravertebral block is an alternative to the TEA : it     provides an unilateral sensitive and sympathetic block using a catheter.In our study, the     catheter will be placed by the thoracic surgeon at the end of the surgical procedure, under     direct vision, to insure maximal security also on patients on antiplatelets agents,     anticoagulants or with haemostasis disorders (the placement of the catheter by the     anaesthetist with the loss of resistance technique is contraindicated in these     cases).Patients will be randomized to receive either a continuous 48-hours infusion of     ropivacaine 0,5% or saline serum in the control group.All patients are connected to a PCA     pump with intravenous morphine and will receive paracetamol and nefopam.The visual analogic     scale (VAS) at rest and on movement, total morphine consumption and side effects will be     recorded during the first 48 hours after surgery. The aim of this study is to prove a     decrease of pain at rest and on movement, a decrease of the cumulated total morphine dose     consumption and a decrease of the side effects (nausea, vomiting, pruritus, sedation,     bradypnea, urinary retention).   "
211487|NCT00620503|"     This is an open-label, randomized, single-center, outpatient, unblinded, single-dose,     three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34     years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state,     formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B);     successive dosing will be separated by at least one week intervals from the previous dosing.     Blood will be collected prior to taking the dose, and following the dose for 24 hours     post-dose. Subjects will be discharged from the study after the last blood sample is obtained     after the third dose of Proellex®. Safety will be assessed throughout the study.   "
211516|NCT00620880|"     Primary objective of the trial:      To determine at which concentration the fusion protein MAT Fel d1 degranulates basophils of     cat dander allergic patients, in comparison to a cat dander extract and to Fel d1 alone   "
211517|NCT00620893|"     This study will evaluate and compare 2 artificial tears in their ability to reduce post LASIK     dry eye signs and symptoms. The secondary endpoint of this study is to evaluate refractive     regression in these patients. The 'Refractive Outcome' data point will be defined as the     difference between the post-op spherical equivalent (SE) and the pre-op targeted SE.   "
211488|NCT00620516|"     This is a descriptive observational open non-comparative study of the safety and efficacy of     tiotropium inhalation capsule given at 18mcg once a day for 30 days among Korean patients     with COPD. At Visit 1, patients who are diagnosed as COPD will be prescribed tiotropium     inhalation capsule at 18mcg once daily (at the same time). Patients' FEV1 will be assessed     before start of treatment (Visit 1) and at the end of the 30 day treatment period (Visit 2).     Occurrence of adverse events will also be asked from the patient at the end of the 30 day     treatment period. Patients will be informed by the attending physicians to immediately report     the occurrence of serious adverse events.   "
211489|NCT00620529|"     We hypothesise that fish oils will have a beneficial effect on cardiometabolic parameters in     women with PCOS. The purpose of this study therefore is to examine the effects of fish oils     on blood pressure, heart rate variability and liver fat content in obese women with the     polycystic ovary syndrome.   "
211490|NCT00620542|"     A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing     the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic     disease burden as measured by intravascular ultrasound in patients with coronary artery     disease.   "
211491|NCT00620555|"     Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric     patients with partial seizures   "
211492|NCT00620568|"     This is a randomized, inpatient, ascending multiple dose study to assess safety and     tolerability of SLV-313 SR tablets administered orally to subjects with schizophrenia and     schizoaffective disorder.   "
211493|NCT00620581|"     The efficacy of SSRI use to relieve the symptoms associated with premenstrual dysphoric     disorder has been established. We proposed to test the hypothesis that intermittent treatment     with paroxetine administered during the luteal phase of the menstrual cycle only is more     effective than placebo in improving symptoms of PMDD. This was a double-blind,     placebo-controlled, three-arm parallel group study of patients with PMDD. Menstruating women     18 years of age or older who met criteria for inclusion in the study were randomized to one     of three arms: paroxetine 10mg/day during the luteal phase of the menstrual cycle; paroxetine     20mg/day during the luteal phase of the menstrual cycle; placebo daily during the luteal     phase of the menstrual cycle. The objective was to evaluate the efficacy and safety of     intermittent treatment of paroxetine in women with PMDD.   "
211620|NCT00607815|"     The purpose of this study is to compare the effectiveness of Cognitive Processing Therapy     (CPT) versus Present Centered Therapy (PCT) for male OEF/OIF Veterans with combat related     PTSD.   "
211494|NCT00620594|"     This is a first-in-human, phase I/Ib clinical research study with BEZ235, an inhibitor of     phosphatidylinositol 3'-kinase (PI3K). The study consists of a dose escalation part followed     by a safety dose expansion part:      Dose escalation part (advanced solid tumors, including patients with breast cancer being     treated with trastuzumab):      Patients receive oral BEZ235 once daily on days 1-28 of the first course. Courses will repeat     every 28 days in the absence of disease progression or unacceptable toxicity.      Cohorts of at least 3 patients receive escalating doses of BEZ235, as single agent or in     combination with trastuzumab, until the maximum tolerated dose (MTD) is determined. The MTD     is defined as the dose expected to produce during the first course of treatment dose-limiting     toxicity in 33% of patients.      Once the MTD has been defined, the safety expansion parts of the trial will be opened for     enrollment.      Safety dose expansion part (advanced solid tumors, including patients with breast cancer     being treated with trastuzumab):      Patients will be treated with BEZ235, as single agent or in combination with trastuzumab,     given at the MTD, once daily. Treatment of patients will continue until disease progression     or occurrence of unacceptable side effects.   "
211495|NCT00620607|"     To assess the response rate of huC242-DM4 given as an intravenous infusion to patients with     metastatic or locally advanced gastric or gastroesophageal junction cancer.   "
211496|NCT00620620|"     The purpose of the study is to determine the safety, tolerability and pharmacokinetics of     zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers   "
211497|NCT00620633|"     This study will test the safety of giving you specialized white cells from your donor. They     are called WT1 sensitized T cells. They have been grown in the lab and are immunized against     a protein. The protein is called the Wilms' tumor protein, or WT1. Your leukemic cells make     too much of this protein. We want to learn whether the WT1 sensitized T cells will attack the     protein and kill the leukemia cells.   "
211498|NCT00620646|"     To compare the effect of increased dosing of clopidogrel and adding cilostazol to standard     dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel     resistance   "
211499|NCT00620659|"     The purpose of this study is to determine the safety and efficacy of MK0249 in treating     refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep     Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP)     therapy.   "
211500|NCT00620672|"     Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for     humans, and are known to be important to reducing the risk of certain diseases, particularly     those related to neural system, cardiovascular system and immune system. Among the different     n-3 fatty acids, docosahexaenoic acid (DHA) is present in particularly high amounts in the     brain and retina, and is accumulated in large amounts in these organs during the last     trimester of fetal development and first few months after birth. The n-3 fatty acids are     present in the diet as linolenic acid which is found in vegetable and seed oils, and as DHA     which is only found in animal tissue fats, with fatty fish being the richest dietary source.     Humans are able to convert linolenic acid to DHA, but the conversion is believed to be slow     in human and possibly inadequate to support the needs for DHA for the developing brain.     Information from our work and those of others has suggested that DHA is important during     pregnancy, however specific evidence is lacking to show that the DHA status of pregnant women     in low, or that improvement in the DHA status of Canadian women during pregnancy will have     benefit to early infant an child development. There is no evidence that infants of vegans and     vegetarians, or women who do not eat DHA are at risk for developmental delays. The purpose of     this study is to investigate whether a dietary supplement of DHA during pregnancy has any     effect on infant birth weight, or indices of infant growth, visual, mental and motor skill     development.   "
211501|NCT00620685|"     The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well     tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not     effect the blood levels of methotrexate.   "
211502|NCT00620698|"     Trials evaluating new therapies for stopping or slowing the progression of ALS depend     critically upon the use of outcome measures to assess whether a potential treatment is     effective. The more effective an outcome measure, the fewer patients need to be enrolled and     the shorter the trial. Many outcome measures have been used over the years, including     strength assessments, breathing tests, functional status surveys, and nerve testing, but all     are far from ideal. A new method, called electrical impedance myography (EIM) appears to be     especially promising in that it provides very consistent data from one testing session to the     next, is sensitive to the muscle deterioration that occurs in ALS, and is entirely painless     and non-invasive. In this study, investigators from multiple institutions plan to compare     several different outcome measures, including EIM, in approximately 120 ALS patients, with     each patient being followed for a period of one year. All of these measures will be compared     to one another and an assessment of their ability to detect disease progression made. Our     goal will be to determine whether EIM can serve as a valuable new outcome measure, ultimately     leading to substantially faster, more effective ALS trials requiring fewer patients.   "
211503|NCT00620711|"     The hypothesis is that premature infants' can have enough cooling applied to cool their brain     to decrease CNS injury without cooling their body.   "
211504|NCT00620724|"     The objective of our study is to determine the clinical utility related to the maintenance     oral nifedipine therapy in patients with symptomatic placenta previa. This study is a     prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of     hospitalized patients with symptomatic placenta praevia. All patients may initially receive     oral nifedipine therapy with steroid prophylaxis for 48 hours. After then, patients are     randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one     every 8 hours) until 37 weeks of gestation.      The primary outcome for the trial is the length of pregnancy in days after the enrollment. A     sample size calculation is designed to detect at least a 14 -day difference in time gained in     patients with maintenance oral nifedipine therapy. A sample size of about 52 patients per     group would have a 80 % chance of detecting this difference at the 5 % level of significance.   "
211505|NCT00620737|"     The purpose of this study is to evaluate the safety profile and the treatment effect of     Isolagen TherapyTM and placebo when administered to stable restrictive burn scars of an     affected joint area.   "
211508|NCT00620776|"     The purpose of this study is to conduct a preliminary evaluation of the efficacy of combined     medication and psychotherapy for generalized anxiety disorder (GAD). The general goals of the     current study are to conduct a late stage treatment development study. The goal of this stage     of research is to provide a preliminary answer to the question and to gather data to estimate     intervention parameters (e.g., effect size, attrition rates, response rates) that would     assist in planning further research.   "
211509|NCT00620789|"     This study is a randomized clinical trial to test the efficacy of Cognitive-Behavioral     Insomnia Therapy when used in isolation or in combination with antidepressant medication     (escitalopram) among patients with Major depressive disorder and insomnia.   "
211510|NCT00620802|"     CG106 is a Phase I open-label, randomized, multiple-dose, two-way crossover study to     characterize the pharmacodynamics and pharmacokinetics of the investigational fixed-dose     combination product CGT 2168 (clopidogrel, 75 mg and omeprazole, 20 mg) relative to Plavix®     (clopidogrel, 75 mg).      Healthy volunteer subjects will undergo two dosing periods. In each 7-day dosing period,     subjects will receive oral doses of study drug consisting of open-label CGT 2168 or Plavix®     in the order determined by the randomization schedule. Each period of dose administration     will be separated by a two-week washout period. Study exit will occur 1 week after Dosing     Period 2. The expected total duration of participation is 8 weeks (56 days), including a     screening visit on or within 21 days prior to enrollment.      On the day before Day 1 and Day 7 in each dosing period, subjects will be admitted to the     Phase I unit. Blood samples to determine ADP-induced platelet aggregation will be collected     pre-dose on Day 1 and 2 h after dosing on Day 7. Plasma concentrations of clopidogrel parent     and clopidogrel carboxylic acid metabolite will also be measured pre-dose on Day 1 and     pre-dose and serially after dosing on Day 7.   "
211511|NCT00620815|"     Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years     and above (as part of a tetravalent vaccine)   "
211512|NCT00620828|"     The purpose of this study is to use a new combination of anesthesia techniques in an attempt     to minimize early pain after surgery and improve the patient's ability to participate more     fully with physical therapy. Total knee replacement patients who participate will receive the     standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The     study is looking at the added benefits of including an injection of numbing medication     (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to     compare the outcomes we will also have a group of patients who will receive a saline     injection as opposed to the numbing medication. Patients are randomly assigned to a group.     Outcomes are measured up until twenty-four hours following the surgery.   "
211513|NCT00620841|"     A retrospective analysis of the influence of gene polymorphisms on drug interactions between     calcineurin-inhibitors and concomitant drugs in renal transplant patients.   "
211519|NCT00620919|"     1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the          diameter of the pancreatic duct when used during Multidetector Computed Tomography          (MDCT) of the pancreas.        2. To demonstrate that RG1068-enhanced MDCT improves image quality of the pancreas in          patients with chronic pancreatitis.        3. To evaluate if RG1068 enhanced MDCT results in improved delineation of structural          abnormalities of the pancreatic duct as compared to non-enhanced MDCT.   "
211520|NCT00620932|"     The primary objective is to determine the feasibility and acceptability of a home-based     endurance exercise program among men diagnosed with clinically localized prostate cancer.   "
211521|NCT00620945|"     Cardiopulmonary bypass [CPB] in small size bodies can result in decreased peripheral     perfusion. This results in anaerobic metabolism as evidenced by lactic acidosis. High flow     perfusion results in systemic hypertension which is accentuated by moderate hypothermia     commonly used during cardiopulmonary bypass. Phenoxybenzamine [PBZ] is an arteriolar     vasodilator that acts by irreversibly blocking the alpha adrenergic receptors. It causes     vasodilatation allowing high flow, low pressure CPB. It has been used extensively outside US     in Canada, Europe and Australia. In the US oral PBZ is FDA approved, whereas intravenous PBZ     is only available as an investigational drug   "
211522|NCT00620958|"     This study will compare the effectiveness of individual cognitive behavioral therapy with two     distinct types of parent involvement versus individual cognitive behavioral therapy without     parent involvement in treating children with anxiety disorders. Hypothesized mediator of     change for eac of the two parent treatment conditions also will be evaluated   "
211523|NCT00620971|"     This trial will evaluate whether the sequential administration of     Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the     Cisplatin/Docetaxel/Bevacizumab combination as first line treatment offers a survival     advantage in patients with locally advanced or metastatic NSCLC.   "
211524|NCT00620984|"     Lactation (breastfeeding) mastitis is an acute infection of the milk ducts of the     breastfeeding woman. Staphylococcus aureus (S. aureus) is the infectious germ most commonly     associated with lactation mastitis. Twenty percent of the general population are carriers of     Staphylococcus aureus, which means that they carry the infectious germ but do not become ill     from it. It has been suggested that mothers who are carriers of S. aureus in their nostril     may be at an increased risk of developing lactational mastitis, however; this has not been     clinical proven.      We are studying the relationship between S. aureus carrier status of breastfeeding mothers     and infants and the risk of developing lactational mastitis. Additionally, we are collecting     questionnaire data in an attempt to better define factors predisposing women to lactation     mastitis.   "
211544|NCT00621257|"     Research has shown that children with Inflammatory Bowel Disease may have lower levels of     vitamin D than healthy children, especially in the winter. Vitamin D is important for growing     and maintaining healthy bones throughout life, and this is particularly important, since     children with IBD frequently have low bone density. It may also be helpful in the treatment     of IBD itself, because it helps reduce inflammation. Vitamin D levels are measured by the     amount of 25 OHD in the blood; however, measuring this level on a regular basis is not yet     the standard for children with IBD. The purpose of this study is to find the best way to     treat low vitamin D levels, and to maintain good vitamin D levels throughout the year. It     will also test whether having higher vitamin D levels will improve the bone health of     children with IBD, and whether it will help them have milder disease.   "
211525|NCT00620997|"     Introduction: Traumatic injuries to the outer covering of the eye (the cornea) are a common     emergency department complaint. They cause significant patient distress including pain, loss     of sleep and missed work days. There is currently no accepted, uniform approach to pain     management in this patient population. Emergency medicine and ophthalmology texts state that     prolonged use of medications that anesthetize the cornea is not recommended. Several recent     publications in the ophthalmology literature show that the outpatient use of dilute local     anesthesia in patients after eye surgery is a safe and effective method of pain control. In     this study, we used Proparacaine (a local anesthetic), in a similar manner, for the     outpatient emergency department management of traumatic corneal injuries.      Methods: We performed a clinical trial on a sample of adult patients presenting with     traumatic corneal injuries to two university affiliated emergency departments in London,     Canada.      Patients providing signed informed consent to participate in the study received a vial of     clear liquid that contained either Proparacaine or plain water (placebo), a pain log, topical     antibiotics and oral Acetaminophen (Tylenol) with Codeine for breakthrough pain.      Patients were instructed to use the study drug on an as-needed basis for the next seven     days. Patients completed a pain scale describing their discomfort immediately prior to, and     five minutes after self-administration of the study drug. All patients were followed closely     in an ophthalmology outpatient clinic on Days 1, 3 and 5 after presentation to the emergency     department. At the last ophthalmology clinic visit, the patients' pain logs were collected.      The protocol was approved by the Research Ethics Board for Health Sciences Research Involving     Human Subjects at the University of Western Ontario.   "
211526|NCT00621010|"     This study is the first human exposure for the drug candidate CTS21166 in healthy male     volunteers   "
211527|NCT00621023|"     This will be an open-label, non-randomized trial pilot phase II trial open to patients with     myelodysplastic syndrome. The purpose of the study is to find out if the combination of     decitabine, arsenic trioxide and ascorbic acid is safe.   "
211528|NCT00621036|"     RATIONALE: Vaccines made from a person's cancer proteins may help the body build an effective     immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may     increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine     therapy together with GM-CSF may make a stronger immune response and kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects and how well giving vaccine therapy     together with GM-CSF works in treating patients with CNS lymphoma.   "
211529|NCT00621049|"     Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin,     docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with     completely resected stage IB, II, and select III NSCLC.   "
211530|NCT00621062|"     Through a prospective RCT evaluate and compare the three new endovenous methods for great     saphenous vein ablation (Radiofrequency, endovenous laser and foam sclerotherapy) versus high     ligation and stripping. Procedure (proof-of-concept) and patient related (clinical outcome)     factors will be studied.   "
211531|NCT00621075|"     The goal of our study is to correlate data from non-invasive tests such as perfusion lung     scans with hemodynamic measurements from right heart catherizations.   "
211532|NCT00621088|"     This is a study to compare the new nail INTERTAN with a Sliding Hip Screw in treating a     specific group of hipfractures (trochanteric and subtrochanteric fractures).      Are there differences in terms of pain, early and late functional mobility and complications     between the to implants (and methods of operation)?   "
211533|NCT00621101|"     The purpose of this study is to confirm a significant influence of ezetimibe and sirolimus on     each others pharmacokinetics   "
211534|NCT00621114|"     The clinical study aims at providing data on antimicrobial efficiency and a supposed     additional preventive effect on catheter-related infections of a catheter with antibacterial     surface coating in comparison to standard catheters without coating.   "
211535|NCT00621140|"     To investigate efficacy, safety and tolerability of BI 1356 versus placebo   "
211536|NCT00621153|"     To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either     candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen   "
211538|NCT00621179|"     This prospective randomized trial evaluates whether one can predict which infertile women     with endometriosis who are candidates for in vitro fertilization will benefit from prolonged     therapy with a GnRH agonist by the determination of the absence of endometrial expression of     the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which     all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for     in vitro fertilization and then undergo randomization to a three month course of a depot     preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian     stimulation or standard therapy. prio   "
211539|NCT00621192|"     Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is     used in premature and young infants, the correct dose is not known. The purpose of this study     is to determine the correct dose and the safety of meropenem for the treatment of complicated     intra-abdominal infections in these young babies.   "
211540|NCT00621205|"     Lifestyle and genetic factors interact in the development of obesity and the metabolic     syndrome. The molecular mechanisms underlying the beneficial dietary modifications are,     however, unclear. We aimed to examine the effect of the long-term 30 moderate weight     reduction on gene expression in adipose tissue (AT) and to identify genes and gene clusters     responsive to treatment and thereby likely contributing to the development of the metabolic     syndrome. Thus, randomized controlled and individualized weight reduction and physical     exercise intervention was conducted. In the WR group, glucose metabolism improved that was     not seen in other groups. Moreover, an inverse correlation between the change in SI and the     change in body weight was found (r =-0.44, p=0.026). Down-regulation of gene expression     (p<0.01) involving gene ontology groups of extracellular matrix, cell death was seen. Such     changes did not occur in the other groups.   "
211541|NCT00621218|"     To compare the efficacy and safety of tretinoin gel 0.05% to its vehicle when dosed once or     twice daily in female subjects with rosacea.   "
211542|NCT00621231|"     The aim of the proposed study is to investigate the effects of different amounts of protein     intake primarily from meat on muscle function, immune response, mental function, proteomics,     biochemical regulators of protein metabolism, energy expenditure, and composition in young     healthy males.   "
211543|NCT00621244|"     This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or     anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies   "
211545|NCT00621270|"     The purpose of this study is to determine whether BCI-540 80 mg given once daily (q.d.) or     three times daily (t.i.d.) is effective in the treatment of major depression with concomitant     anxiety.   "
211546|NCT00621283|"     1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the          diameter of the pancreatic duct when used during Magnetic Resonance Pancreatography.        2. To demonstrate that RG1068-enhanced MRCP improves image quality relative to unenhanced          MRCP in patients with unexplained acute recurrent pancreatitis (ARP) and chronic          pancreatitis.        3. To evaluate if the use of RG1068-enhanced MRCP improves structural delineation of the          pancreatic duct as compared to the non-enhanced MRCP.        4. To assess pancreatic exocrine function by quantifying pancreatic fluid output into the          duodenum and the apparent diffusion coefficient of the pancreas.   "
211547|NCT00621296|"     The purpose of this study is to assess the efficacy and safety after administration of MP-424     to patients with chronic hepatitis C.   "
211548|NCT00621309|"     Adverse drug-drug interactions (DDIs) are responsible for approximately 3% of all     hospitalizations in the US, perhaps costing more than $1.3 billion per year. One of the most     common causes of DDIs is the when one drug alters the metabolism of another. A key enzyme in     the liver and intestine, called cytochrome P450 3A4 (CYP3A4) is generally considered to be     the most important drug metabolizing enzyme. The gene for CYP3A4 can be 'turned on' by the     presence of certain other drugs, resulting in much higher levels of CYP3A4 in the liver and     intestine. Thus, when a drug that induces CYP3A4 is given with or before another drug that is     metabolized by 3A4, a 'drug-drug' interaction occurs because the first drug (the inducer)     greatly changes the rate at which the second drug (CYP3A4 substrate) is removed from the     body. Many drugs increase CYP3A4 activity by binding to a receptor called the     Pregnane-X-Receptor (PXR), which is a major switch that controls the expression of the CYP3A4     gene. Using human liver cells we have demonstrated that sulforaphane (SFN), found in     broccoli, can block drugs from activating the PXR receptor, thereby inhibiting the switch     that causes CYP3A4 induction. The purpose of this project is to determine if SFN can be used     to block adverse DDIs that occur when drugs bind to and activate the PXR receptor and     subsequently induce CYP3A4 activity. We will recruit 24 human volunteers to participate in     the study. This project will determine whether SFN can prevent the drug Rifampin from binding     to PXR and increasing CYP3A4 activity in humans following oral administration of SFN     (broccoli sprout extract). The rate of removal of a small dose of the drug midazolam will be     used to determine the enzymatic activity of CYP3A4 before and following treatment with     Rifampin, in the presence or absence of SFN, since midazolam is only eliminated from the     bloodstream by CYP3A4. . We predict that SFN will prevent the increase in midazolam clearance     (metabolism) that normally follows treatment with the antibiotic, rifampicin.      This research is important because it could potentially lead to a simple, cost-effective way     of preventing one of the most common causes of adverse drug-drug interactions that occurs     today. For example, rifampicin, which is a cheap and effective antibiotic used to treat TB,     cannot be used in HIV/AIDS patients because it increases the metabolism of many of the     antiretroviral drugs used to treat HIV/AIDS. TB is a major opportunistic infection in AIDS     patients, so this is a serious clinical problem, especially in developing countries where     more expensive alternative drug therapies are not available. We hypothesize that     co-formulation of rifampicin with SFN could block this drug-drug interaction without altering     its efficacy, thereby allowing its use in HIV/AIDS patients infected with TB. This is but one     example of numerous drug-drug interactions that occur via this mechanism.   "
211549|NCT00621322|"     This observer blind study will assess the safety and immunogenicity of different formulations     of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a     positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA     Amendment Act, Sep 2007.   "
211550|NCT00621335|"     The objective of this research study is to compare the tolerability and effectiveness of     Combigan(brimonidine tartrate/timolol maleate) and Cosopt (dorzolamide hydrochloride)in the     treatment of open angle glaucoma or ocular hypertension.   "
211551|NCT00621348|"     Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important     reason for this high incidence could be use of hypotonic fluids in sick children for     maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect     of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized     children.      Hypothesis: Use of normal saline in 5% dextrose or reduced (2/3) volume of N/5 saline in 5%     dextrose reduces incidence of hyponatremia (serum sodium 130 mmol/L) by two-thirds when     compared to N/5 saline in 5% dextrose at standard maintenance rate in hospitalized children     receiving intravenous maintenance fluids.   "
211552|NCT00621361|"     This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in     combination with etoposide and cisplatin (EP) as first line treatment for lung cancer     patients with extensive stage or metastatic disease for whom EP would be a standard therapy.   "
211553|NCT00621374|"     The purpose of this study is to see if treatments that include components of self-hypnosis     training and cognitive behavioral therapy (CBT) can help decrease pain in people with MS.   "
211554|NCT00621387|"     This is a randomized, double-blind, placebo-controlled trial of the effect of 3-month     treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice     daily on clinical course of recent-onset reactive arthritis. Patients are followed-up at     regular intervals until 6 months. The main outcome measure is recovery from arthritis, and     secondary outcome measures include swollen and tender joint counts, Ritchie index, joint     pain, serum C-reactive protein level and blood erythrocyte sedimentation rate. The study will     also address the safety and tolerability of long-term antibiotic treatment. 56 patients are     enrolled and the enrollment of patients has been completed.   "
211555|NCT00621400|"     Amyloidosis results from tissue deposition of amyloid protein, composed mainly by the     fragments of monoclonal immunoglobulin heavy chains or light chains. Accumulation of amyloid     protein progressively disrupts normal tissue structure and ultimately leads to organ failure,     most frequently in the kidneys, heart, liver and peripheral nervous system. A recently     completed French prospective randomized trial, in patients presenting with newly     AL-amyloidosis, compared two treatment regimens at the time of diagnosis:     Melphalan-dexamethasone (conventional oral treatment), versus high dose of Melphalan followed     by autologous stem cell transplantation (ASCT) (1). High-dose therapy was not associated with     a better outcome. Melphalan-dex given monthly can be considered as the current standard of     care, with a median survival of 56 months. The use of a combination of lenalidomide and     dexamethasone has already been tested in patients with AL-amyloidosis (2). The initial dose     of lenalidomide at 25 mg/day was poorly tolerated. However, a 15 mg/day dose regimen was well     tolerated and effective, with an overall hematologic response rate of 67%. Hematologic     responses were associated with clinical responses. Dispenzieri et al confirmed that the     combination of Lenalidomide + dexamethasone achieved a 75% hematologic response rate, with a     42% organ response, and a median follow-up of 17 months in patients still receiving treatment     (2006). These authors also recommended a lower dose of 15mg/day. The rationale for the     present investigation is that addition of lenalidomide to the current standard of care     (Melphalan-dexamethasone) might improve the hematologic response rate and the organ response     rates both associated with a prolonged survival in patients with AL-amyloidosis. As the     toxicity of the combination of M-dex + lenalidomide is unknown in patients with     AL-amyloidosis, the dose of lenalidomide will start from the lowest one available, i.e., 5     mg/day and increased from 5 to 5 mg up to a maximum dose of 15 mg in combination with M-dex     in 3 consecutive cohorts of patients, according to toxicity. When the optimal dose of     lenalidomide will be defined, 9 additional patients will be included in the trial at the     recommended dose-level to assess the feasibility of the combination M-dex-lenalidomide.   "
211556|NCT00621413|"     The purpose of this study is to observe PSA response and incidence of side effects in     patients diagnosed with intermediate to high risk prostate cancer and treated with Cesium-131     in combination of external beam therapy.   "
211621|NCT00607828|"     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor     and cause less damage to normal tissue.      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic     radiation therapy in treating patients with advanced liver cancer.   "
211557|NCT00621426|"     Sudden cardiac death due to arrhythmia is the leading cause of death in end-stage renal     disease (ESRD) patients treated with hemodialysis (HD). As it is anticipated that the number     of individuals with ESRD will exceed 1.2 million in the next 20 years, sudden death in this     population has enormous public health impact. Research has shown that arrhythmic events are     temporally associated with longer periods between HD with a three-fold risk of events in the     12 hours preceding the longest inter-dialysis interval. The exact cause of these findings is     unknown.   "
211558|NCT00621439|"     The purpose of this study is to explore whether the drug pegylated-interferon-alfa-2b     (PEG-IFN) has any effect on a certain type of immune cell (called natural killer cells) in     patients with eye melanoma.   "
211559|NCT00621452|"     This phase I trial is studying the side effects of giving genetically engineered lymphocytes     together with cyclophosphamide and aldesleukin in treating patients with relapsed or     refractory mantle cell lymphoma or indolent B-cell non-Hodgkin lymphoma. Placing a gene that     has been created in the laboratory into white blood cells may make the body build an immune     response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Aldesleukin may stimulate the white blood cells to kill lymphoma cells.     Giving genetically engineered lymphocytes together with cyclophosphamide and aldesleukin may     be an effective treatment for mantle cell lymphoma and B-cell non-Hodgkin lymphoma   "
211560|NCT00621465|"     This study will evaluate the effectiveness of a psychosocial treatment, Critical Time     Intervention, in easing the transition from hospital to community in people with severe     mental disorders.   "
211561|NCT00621478|"     Children with seizures are frequently seen in the emergency department. The drug lorazepam,     which is commonly used, is not labeled by the US Food and Drug Administration for children     for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a     study comparing diazepam, a drug that is labeled by the FDA for this indication, with     lorazepam be performed. The study will show whether one drug is more effective and safe than     the other.   "
211562|NCT00621491|"     The aim of this study was to compare the safety and efficacy of warfarin versus placebo,     administered for 6 months, in the prevention of thromboembolic complications after     transvenous cardiac devices implantation in high-risk patients.   "
211563|NCT00621504|"     The purpose of this study is to determine whether ceftaroline is effective and safe in the     treatment of Community-Acquired Pneumonia   "
211564|NCT00621517|"     The purpose of this study is to determine if bupropion will improve the symptoms of restless     legs syndrome (RLS).   "
211581|NCT00621738|"     Psychological stress is an independent cardiovascular risk factor. Activation of platelets     plays an important role in atherosclerosis development and it could one of the mechanisms     linking psychological stress and cardiovascular diseases   "
211582|NCT00621751|"     The purpose of this study is to determine if carbamazepine reduces irritability and     aggression among individuals with traumatic brain injury   "
211565|NCT00621530|"     Chronic pain in patients following total hip replacement seems to be a significant problem.     Previous research has shown that more effective pain management in the early postoperative     period may decrease the incidence of the development of chronic pain states.      This study will evaluate whether ketorolac (a non steroidal anti-inflammatory drug) given     into the spinal fluid before surgery will reduce the area of sensitivity (or pain to light     touch) following surgery. Patients will be monitored during their postoperative hospital stay     and then contacted by telephone at 8 weeks and 6 months after surgery and questioned about     any pain they are having at their surgical site. Patients that are still experiencing pain at     6 months will be asked to return to the medical center for the study staff to assess their     pain or sensitivity at the surgical site.   "
211566|NCT00621543|"     The purpose of this study is to determine the expulsion and continuation rate of an     intruterine device (IUD) placed immediately after medical abortion.      Our hypothesis is that immediate-placement of an IUD after completed medical abortion will     have a similar expulsion and continuation rate to traditional placement (4-6 weeks after     pregnancy).   "
211567|NCT00621556|"     1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the          diameter of the pancreatic duct when used during Magnetic Resonance Pancreatography        2. To demonstrate that RG1068-enhanced MRCP improves detection and characterization of          intraductal papillary mucinous neoplasms (IPMN) relative to unenhanced MRCP in patients          with suspected IPMN        3. To correlate findings on MRCP with histologically confirmed malignancy   "
211568|NCT00621569|"     The purpose of the study is to develop a culturally appropriate DASH intervention and test     the effectiveness of the intervention lower blood pressure in a group of African American     participants at risk for developing hypertension (pre-hypertension) and those with mild     hypertension (stage I).   "
211569|NCT00621582|"     The objective of the present Post Marketing Surveillance Study (PMS) study is to evaluate     safety and effectiveness of tiotropium bromide (Spiriva®) 18 µg once daily in 5,000 patients     with COPD of varying severities over 8 weeks.   "
211570|NCT00621595|"     To test cognitive abilities of 8-11 year old children under conditions of fasting or     receiving a full school breakfast.   "
211571|NCT00621608|"     The purpose of this study is to determine if HBOT plus standard wound care is more effective     than standard wound care alone at preventing the need for major amputation (metatarsal and     up) in patients with diabetes mellitus (Type 1 or 2) with moderate to sever chronic wounds of     lower limbs.   "
211572|NCT00621621|"     The purpose of this post approval study of heart block is to gather additional information     regarding how often patients develop heart block (atrioventricular block) after having     standard ablation procedure using cryotherapy with the Freezor™ catheter.   "
211601|NCT00621998|"     We initiate a study with research grant from department of health and Taoyuan mental hospital     and choose risperidone and olanzapine as study medications. We compare the effects of these 2     drugs in schizophrenic spectrum patients of Han ethnics with neuroleptic-induced tardive     dyskinesia to test the hypothesis that these two medications have different effects in     improving tardive dyskinesia.   "
215926|NCT00677573|"     We proposed to compare outcomes in women with DOR undergoing ART with rec-FSH + u-HMH with     those with u-FSH only in GnRH antagonist protocols.   "
211573|NCT00621634|"     Tardive dyskinesia (TD) is a well-known complication of antipsychotic drug therapy in     individuals treated for mental disorders such as schizophrenia. It typically consists of     purposeless, involuntary movements involving the mouth area or the trunk and limb muscles,     occurring within months or years of drug use. The annual incidence of TD in the population     treated with antipsychotic drugs is between 1-5%, but the risk is 5-fold greater in older     individuals. Once triggered, TD is often irreversible and untreatable. Its cause is unknown,     but an imbalance between chaotic mechanisms triggered by the drugs and natural protective     factors fighting against these may provide an explanation. One way to activate this     protective response is to supplement the diet with high doses of essential fatty acids of the     omega-3 class, which constitute a critical component of nerve cell membranes. Using this     strategy, one research team showed a 50% reduction in the severity of TD-like movements in     mice treated with docosahexaenoic acid (DHA). We hypothesize that DHA supplements can do the     same in patients living with schizophrenia displaying TD movements. Forty (40) subjects     between 30-75 years of age will be recruited. The participants will be randomized and equally     distributed in two groups to take either DHA capsules (3 grams a day) or matching placebo for     12 weeks, after providing informed consent, and TD will be measured with a magnetic tracker     system and clinical scales. The finding of a beneficial effect with DHA against TD would     improve the quality of life for thousands of patients under long-term antipsychotic drug     treatment.   "
211574|NCT00621647|"     The purpose of this study is to determine how safe and effective Seroquel (quetiapine     fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the     treatment of agitation symptoms in nursing home or assisted care residents.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
211575|NCT00621660|"     The aim of this study is to evaluate if acupuncture prevents or reduces nausea or vomiting     during radiotherapy   "
211576|NCT00621673|"     Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study     is to further monitor whether participants with severe Hemophilia A will develop inhibitors     or antibodies at the later stage when switched from their current recombinant therapy     produced from Chinese Hamster Ovary (CHO) cell line to Kogenate-FS raised in a Baby Hamster     Kidney cell line.   "
211577|NCT00621686|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib     may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving     bevacizumab together with sorafenib may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab     together with sorafenib works in treating patients with recurrent glioblastoma multiforme.   "
211578|NCT00621699|"     The purpose of this study is to confirm a significant influence of ezetimibe and tacrolimus     on each others pharmacokinetics   "
211579|NCT00621712|"     The study investigates the efficacy of a catheter with antibacterial surface coating in     preventing central venous catheter related infection and the effect of an intensive hygiene     and catheter care education of the nursing staff on preventing central venous     catheter-related infection.   "
211580|NCT00621725|"     To determine how patients with advanced cancer and various degrees of hepatic impairment will     metabolise Cediranib.   "
211584|NCT00621777|"     Varenicline (Chantix) is a smoking cessation treatment that was approved in 2006 by the FDA     for treatment of nicotine dependence and may be particularly beneficial in smokers with     schizophrenia or bipolar disorder. Early experience with varenicline indicates that it will     be effective for smoking cessation in schizophrenia and in addition, has the potential to be     therapeutic for cognitive dysfunction in this population. In addition, more data is needed to     evaluate the safety, tolerability and effectiveness of Varenicline in people with bipolar     disorder.      To assess this possibility, we will evaluate the safety and efficacy of 12 months of     varenicline in schizophrenia or bipolar disorder patients who are able to quit smoking in the     short term with this treatment. To do so, we will enroll 324 smokers with schizophrenia or     bipolar disorder from 6 mental health clinics in Massachusetts, New Hampshire, Michigan and     Minnesota into an open, 12-week smoking cessation program that includes varenicline added to     weekly group cognitive behavioral therapy (CBT). Those who achieve at least 2 weeks of     continuous abstinence during the last 2 weeks of the open intervention will be randomized to     the relapse prevention phase: a 40-week, double blind, placebo-controlled trial of     varenicline at the dose used to quit smoking added to a tapering CBT schedule. Participants     will then discontinue study medications and behavioral treatment and enter a 3-month follow     up phase.   "
211585|NCT00621790|"     Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring     renal replacement therapy.      Fenoldopam, already used for patients with hypertensive emergencies, could improve renal     function in critically ill patients with or at risk for acute renal failure.   "
211586|NCT00621803|"     Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is     an infection control strategy used to reduce the occurrence of nosocomial infections -     including ventilator-assisted pneumonia - in intensive care units. The use of antibiotics is     controversial and can lead to adverse effect such as the selection of highly resistant     pathogens. The purpose of this study was to investigate the effect of oral administration of     a probiotic strain, Lactobacillus, on gastric and respiratory tract colonisation/infection by     Pseudomonas aeruginosa strains, according to the concept that an indigenous flora has a     protective effect against secondary colonisation.   "
211587|NCT00621816|"     Nitroprusside is used commonly in the Intensive Care Unit for long periods of time in order     to reduce blood pressure. It is not known if the body compensates over time to the blood     pressure lowering, and if when the nitroprusside is stopped the blood pressure goes up at a     faster rate and is higher than it was at the start of the treatment. This study will answer     these questions.   "
211616|NCT00622206|"     Compare the Pharmacokinetics of ritonavir and saquinavir(using either Saquinavir /Ritonavir     1500/100 mg or 1500/50 mg) Evaluate short term tolerability, safety and toxicity Evaluate if     there is any relation between RTV concentration levels and boosting effect   "
211588|NCT00621829|"     This is a clinical study that is designed to study the effects of the supplemental intake of     enriched omega-3 polyunsaturated fatty acids (fish oil) in patients with moderate to severe     asthma. Some asthmatics produce a large amount of inflammatory leukotriene proteins—proteins     that contribute to wheezing and inflammation in the airway. Inhibiting the detrimental     effects of leukotrienes is a key goal of controller therapy in severe asthmatics. Some     asthmatic patients appear to have specific mutations of the arachidonate 5-lipoxygenase     (ALOX5) gene, one gene that regulates the production of the inflammatory leukotrienes.     Omega-3 fatty acids can interfere with the arachidonic acid pathway and decrease the     production of leukotrienes, and this may benefit moderate and severe asthma patients. Our     hypothesis is that omega-3 fatty acid supplements, added on to a patient's asthma medication     regimen, can decrease the number of minor asthma exacerbations compared to patients who do     not receive the supplement. Furthermore, we believe that asthma patients with specific ALOX5     gene mutations will benefit most. We will enroll 30 asthma subjects to take part in this     trial. They will undergo genotyping of the ALOX5 gene and be treated with omega3-fatty acids     (fish oil) and placebo over a nine month period. We expect that this strategy will allow us     to discover which moderate and severe asthma patients will benefit most from supplements of     omega-3 fatty acids. Treatment of chronic diseases, such as asthma, is a key mission of the     Center of Health and Nutrition Research.   "
211589|NCT00621842|"     This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with     type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II     depression, confirmed via the Structured Clinical Interview for the Diagnostic and     Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting     inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton     Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200     mg/day.   "
211590|NCT00621855|"     The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4     doses of orally administered dabigatran etexilate, administered twice daily, compared to     placebo when given in addition to dual antiplatelet treatment in patients with an index event     (MI) at high risk for new ischaemic cardiovascular events.   "
211591|NCT00621868|"     The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of     ASP1941 in male and female patients with type 2 diabetes mellitus   "
211592|NCT00621881|"     This is an open-label study that will compare the pharmacokinetic and safety effects of     naproxcinod in hepatic impaired patients vs. matching healthy subjects.   "
211593|NCT00621894|"     The purpose of this study is to assess the ability of LGD-4665 given daily by mouth to     increase platelet counts in the treatment of patients with ITP (immune thrombocytopenic     purpura). LGD-4665 increased platelet counts safely and tolerably compared to placebo in     healthy volunteers. This study will examine the safety, tolerability and efficacy of 7.5 mg     capsules of LGD-4665 to increase platelets compared to placebo, randomized 2:1, during     blinded treatment for 6 weeks. Evaluation of platelet counts, bleeding scores and safety     parameters will be done weekly. All patients are eligible to continue on active, open     LGD-4665 treatment for an additional 12 weeks with optimal adjustment of dose for each     patient.   "
211594|NCT00621907|"     The locoregional anaesthesia is increasingly important in surgical practice, often allowing     to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading     to a longer hospitalization because of the pain resulting from the surgery. The     Levobupivacaïne (Chirocaïne) administered through catheters placed in the caesarean scars,     showed its efficiency in post-operative analgesia.      Method : realization of a double blind prospective randomized study, control versus placebo     Purpose : to show that the local administration of a unique dose of analgesia reduce the     post-operative pain with a little or non-invasive technique   "
211596|NCT00621933|"     Topical fluoroquinolones (FQs) have achieved widespread use in ophthalmology for both the     treatment and prophylaxis of ocular infections. The present study is set to determine the     bacteria present on the ocular surface in patients at the time of cataract surgery and to     assess the rate of resistance of ocular isolates to commonly used topical antibiotics.   "
211597|NCT00621946|"     The purpose is to determine if: 1) Escitalopram treatment will be associated with less oral     corticosteroid use than placebo in outpatients with severe asthma and moderate or severe     major depressive disorder (MDD). 2) Escitalopram treatment will be associated with greater     improvement in asthma symptoms than placebo in outpatients with severe asthma and moderate or     severe MDD. 3) Escitalopram treatment will be associated with greater depressive symptom     remission rates than placebo in outpatients with severe asthma and moderate or severe MDD.   "
211598|NCT00621959|"     The study objective is to investigate the efficacy of levocetirizine in reducing symptoms     associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life   "
211599|NCT00621972|"     This is an observational study assessing the impact of conventional dose iodinated contrast     on the renal function of advanced chronic kidney disease patients undergoing arteriovenous     fistula evaluation using a standard sodium bicarbonate prophylaxis protocol. In addition,     this model allows for pre and post procedure measurements of kidney function, providing a     unique opportunity to assess the utility of novel biomarkers for contrast-induced kidney     injury.      Our primary hypothesis is that there will be no change in serum creatinine post-procedure     when using a standard sodium bicarbonate prophylaxis protocol. Our secondary hypothesis is     that there will be no change in urinary kidney-injury marker-1 (KIM-1) post-procedure using a     standard sodium bicarbonate prophylaxis protocol. In addition, we will assess the impact of     different patient characteristics on the development of contrast-induced kidney injury, such     as diabetes, coronary artery disease, hypertension, and angiotensin converting enzyme     inhibitor therapy.   "
211600|NCT00621985|"     The purpose of this study is to determine if dexamethasone given at night is a more effective     treatment for congenital adrenal hyperplasia in young children than standard three times per     day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more     efficient suppression of the hypothalamic-pituitary-adrenal axis. We performed a cross-over     trial comparing hormonal control during two 24-hour hospitalizations, one on hydrocortisone     and one on nocturnal dexamethasone.   "
211617|NCT00622219|"     The goal of this project is to determine the barriers to, and risks and benefits of random     laboratory drug testing for adolescents with identified drug or alcohol problems.   "
211602|NCT00622011|"     Delirium is an organic psychiatric syndrome characterized by fluctuating consciousness and     impairment in perception, cognition and behavior. In hospitalized elderly, the prevalence of     delirium ranges from 10% to 40%. If untreated, delirium is associated with significant     morbidity and mortality. Treatment of delirium consists of identifying and managing     underlying medical abnormalities and the associated psychiatric symptoms. Conventional     antipsychotics have been the mainstay of treatment of agitation and psychosis associated with     delirium; but their use is limited in terms of EPS side effects. Second-generation     antipsychotic agents have been reported to have a lower incidence of extrapyramidal side     effects and tardive dyskinesia which has resulted in their increased use in the treatment of     delirious patients. However, there is still no consensus regarding standard pharmacologic     treatment of this syndrome that takes use of second-generation antipsychotic agents into     account.      Risperidone and zotepine have a lower incidence of EPS and are effective in treating     disturbing psychotic behaviors. We hope to compare the efficacy and safety of risperidone and     zotepine in the treatment of delirium and the correlation between the severity of delirium     with autonomic dysfunction.   "
211603|NCT00622024|"     Postoperative arrhythmias (heart irregularities) are one of the most common complications     after cardiac surgery and are associated with increased morbidity and mortality. Preoperative     depression may be an important co-factor in the generation of postoperative arrhythmias due     to sympathetic hyperactivity evident in patients with depression.      Objectives: To determine the effect of preoperative depression on postoperative arrhythmia in     patients undergoing elective coronary artery bypass graft (CABG) surgery.      Prospective observational study, 120 patients undergoing elective CABG surgery ECG will be     preformed preoperatively on all patients. All patients will be assessed for signs of     depression using the Prime MD Patient Health Questionnaire (Prime MD PHQ) one week before     surgery and 6 weeks postoperatively.Based on the Prime MD PHQ results, patients will be     divided into two groups: those with or without signs of depression. Heart rate and rhythm     monitoring with Holter will be performed for 3 days postoperatively in order to compare the     incidence of postoperative arrhythmias between groups.      The primary outcome is the number of patients with and without depression suffering from     ventricular and/or supraventricular arrhythmias. Secondary outcomes include all cause     mortality, non-fatal myocardial infarction, cardiac arrest, and congestive heart failure.      CABG surgery is the most common operative procedure in North America and arrhythmias are one     of the most common postoperative complication. It is estimated that about a third of these     cardiac patients suffer from preoperative depression and therefore may be exposed to a higher     risk of perioperative morbidity and mortality. If an association between preoperative     depression and postoperative arrhythmia is found, treatment modalities may be indicated to     reduce the prevalence of perioperative arrhythmia in patients with preoperative depression     undergoing cardiac surgery.   "
211604|NCT00622037|"     To evaluate and compare the effects of PEG-400 based artificial tear and Systane tears in     mild-moderate dry eye patients. TBUT, Visual impact and subjective evaluations will be     assessed in this month long trial.   "
211605|NCT00622050|"     The specific objectives of this project are to:        1. Investigate the effects of reducing TV viewing time on energy intake, eating behavior,          and energy expenditure in overweight or obese adult subjects, thus providing a basis for          evaluating if reducing TV viewing time might be a useful adjunct therapy in obesity          prevention and treatment        2. Analyze the types of foods eaten in conjunction with TV viewing        3. Determine if there is an association between location of TV and BMI.   "
211606|NCT00622063|"     To provide ongoing treatment with ARQ 501 for patients who have benefited from prior     treatment with ARQ 501   "
211607|NCT00622076|"     Randomised controled multicenter trial about the appropriate length of postoperative     catheterization after anterior colporrhaphy. Patients are included at the moment that they     are planned for surgery and are allocated to one of the study arms after the operation in the     recovery by a digital randomisation-procedure. 230 patients will be enrolled in the study and     half of the patients will have a catheter during five days postoperatively and the other half     will be catheterized only during two days. Main outcome measurements regards replacement of a     catheter because of bladder retention and the occurence of cystitis.   "
211608|NCT00622089|"     DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the     ketoconazole molecule for the treatment of elevated blood glucose associated with type 2     diabetes mellitus. Ketoconazole (Nizoral®) is a drug available by prescription for the     treatment of fungal infections however DIO-902 is an investigational drug. DIO-902 may lower     blood glucose by lowering levels of a naturally occurring hormone called cortisol. Elevated     cortisol may contribute to the development of type 2 diabetes.   "
211609|NCT00622102|"     We are performing a research study to learn more about the control of an individual's blood     thinning (anticoagulation) on warfarin. Individuals from an anticoagulation clinic are being     asked to participate in order to see if a lottery which provides the opportunity to win money     in combination with the use of the Med-eMonitor might be useful in helping patients to     achieve better control of their anticoagulation therapy. Half of the participants will be     enrolled in the lottery arm and the other half will be a control group who will receive the     Med-eMonitor only.   "
211610|NCT00622115|"     Primary objective:        -  to characterize the pharmacokinetic and the pharmacodynamic profile after intravenous          bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg          (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations          of enoxaparin in Caucasian healthy subjects.      Secondary objective(s):        -  to compare the pharmacokinetic and the pharmacodynamic profile between 3 different          timing of administration of the UFH        -  to assess the tolerability of the different anticoagulation protocols   "
211611|NCT00622128|"     The purpose of this study is to develop and pilot test and non-pharmacological intervention     designed to prevent the occurence of aggression in persons with dementia.   "
211612|NCT00622141|"     The previous two studies of generic GPO saquinavir failed to prove bioequivalence. In this     study the bio-equivalence will be investigated in healthy Thai volunteers, to see whether the     generic GPO saquinavir shows bioequivalence when boosted with Norvir®. If the generic     formulation is bioequivalent subsequent studies may follow in HIV-1 positive patients.   "
211613|NCT00622167|"     The purpose of this study is to compare different methods of looking at atherosclerotic     plaques in heart arteries. Identifying the characteristics of these plaques noninvasively     would be very valuable. This study is looking at a new CT scanner (DSCT) to noninvasively     image these plaques compared to invasive ultrasound (the current standard).   "
211614|NCT00622180|"     To assess over a 25-week period the efficacy of hand-foot narrow-band ultraviolet B light     versus focal 308-nm light treatment in inducing the return of pigment in vitiligo after skin     minigraft transplants to the backs of the hands in patients with light brown to black skin.     Subject will undergo treatment for 13 weeks.   "
211615|NCT00622193|"     The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in     patients with non-small cell lung cancer.   "
211623|NCT00607854|"     The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced     Intensity Conditioning regimen followed by allogenic stem cell support in patients with     aggressive lymphomas who are responsive to a salvage chemotherapy regimen.   "
211624|NCT00607867|"     We will determine the metabolic response to a Low Biologically Available Glucose Diet     (LoBAG30) in subjects currently receiving the maximum dose of metformin as monotherapy in     whom the glycohemoglobin is not at an acceptable level (>8.0%). Our hypothesis is that     introduction of a LoBAG30 diet to subjects currently treated with a full therapeutic dose of     metformin will improve blood glucose control in people who have not achieved an acceptable     total glycohemoglobin on metformin alone.   "
211625|NCT00607880|"     RATIONALE: Giving chemotherapy drugs through an implanted port reduces the need for multiple     needle sticks. It is not yet known whether one type of port is more effective than another in     reducing infections and other side effects associated with long-term port use.      PURPOSE: This randomized clinical trial is comparing two types of ports in patients with     cancer receiving intravenous chemotherapy.   "
211626|NCT00608348|"     The purpose of this study is to determine if either hypoglycemia or exercise cause     differential responses in muscle and skin sympathetic nerve activity.   "
211627|NCT00608361|"     This phase I trial studies the side effects and best dose of dasatinib in treating patients     with solid tumors or lymphomas that are metastatic or cannot be removed by surgery. Dasatinib     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
212216|NCT00630760|"     This phase I study will determine the safety profile of NRX 194204 on this schedule; it will     evaluate the pharmacokinetic profile of NRX 194204 in cancer patients; and will investigate     anti-tumor activity as manifested by standard response criteria, or by tumor markers.   "
211628|NCT00608374|"     RATIONALE: Drugs used in chemotherapy, such as chlorambucil and fludarabine, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. It is not yet known whether chlorambucil is more effective than     fludarabine in treating Waldenström macroglobulinemia, splenic lymphoma, or lymphoplasmacytic     lymphoma.      PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works     compared with fludarabine as first-line therapy in treating patients with previously     untreated Waldenström macroglobulinemia, splenic lymphoma, or lymphoplasmacytic lymphoma.   "
211629|NCT00608387|"     Cardiovascular disease (CVD) is a serious health concern for American Indians, but there have     been few behaviorally based programs to lessen CVD risk among this population. The purpose of     this study is to evaluate whether a Web-based program, in addition to usual medical care, can     lower CVD risk factors among American Indians who have type 2 diabetes and a high risk of     developing CVD.   "
211630|NCT00608400|"     The parathyroid gland and its hormone have a major impact on the endocrine control of bone     metabolism and mineralization and parathyroid hormone (PTH) has been identified in some     epidemiological reports to relate adversely to mortality. Previously, the applicant has     demonstrated in two models that dietary cis-9, trans-11 conjugated linoleic acid (CLA)     reduces PTH by over 30% in as little as 4 weeks in male rats without adversely affecting bone     density. Both bioactive PTH and intact PTH assays have been used and both are reduced by CLA.     In one rat model, rats had normal PTH and a sub-group had high PTH due to chronic renal     disease. In the second study, the rats were healthy young males and females. Regardless of     the model and health state, PTH was reduced 30 to 40% by CLA. Of interest, other isoforms of     CLA such as trans-10, cis-12 CLA do not alone result in reduced PTH. The selected CLA isomer     proven to reduce PTH, cis-9, trans 11 CLA, is common to food products such as milk fat and     beef and is thus more physiologically relevant to the human diet. The global objective of     this study is to, for the first time; assess the effects of CLA on PTH in humans,     specifically men.      Healthy men 19-53 years of age are selected since bone mass will have reached a peak by this     age. Beginning with healthy relatively young men is important versus aging or ill individuals     since the effect of CLA on PTH has not been examined and aging and illness might confound the     results.      Subjects will be recruited using posters and local newspaper advertisements from the general     population. Men (n=30/group) with healthy weights will be randomized to receive 0, 1.5 or 3 g     CLA/d for a period of 4 months. At baseline, body weight will be assessed along with whole     body bone, lean and fat mass using dual energy x-ray absorptiometry (DXA). Regional bone mass     (lumbar spine, total hip, femoral neck) will also be examined using DXA. A blood sample will     be taken in the fasted state between 9:00 and 10:00 to examine PTH, ionized Ca, and     biomarkers of bone metabolism. After each 1 month on the study, the measurements will be     repeated until end of study.      Dietary intake will be monitored along with a survey for possible mild side-effects such as     gastrointestinal discomfort. Data will be examined using a mixed model for random (age,     weight, vitamin D status) and fixed effects (diet, time) with post-hoc comparisons using     Bonferroni correction.   "
211631|NCT00608426|"     Tobacco use is the leading cause of premature death in the United States and     disproportionately affects Veterans and certain racial/ethnic minority groups. Most smokers     are interested in quitting; however, current tobacco use treatment approaches are reactive     and require smokers to initiate treatment or depend on the provider to initiate smoking     cessation care. As a result, most smokers do not receive comprehensive, evidence-based     treatment for tobacco use that includes intensive behavioral counseling along with     pharmacotherapy. Proactive tobacco treatment integrates population-based treatment (i.e.,     proactive outreach) and individual-level treatment (i.e., smoking cessation counseling and     pharmacotherapy) to address both patient and provider barriers to comprehensive care.   "
211632|NCT00608439|"     The purpose of this protocol is to investigate the safety, tolerability and effectiveness of     CAST as a treatment for diabetic neuropathy. The primary outcome measure will be Total     Neuropathic Symptom Score. Secondary outcomes will be neurological disability score, nerve     conduction measurements and quantitative sensory testing. Statistical analyses will compare     changes from baseline for CAST- and placebo-treated groups at both time points, compare     effects of CAST at 6 and 12 months and, if numbers permit, compare doses.   "
211642|NCT00608582|"     The purpose of this study is to examine whether repetitive transcranial magnetic stimulation     (rTMS) can be used to improve speech in chronic stroke patients with aphasia. Aphasia     patients can have problems with speech production. The rTMS procedure allows painless,     noninvasive stimulation of human cortex from outside the head.      Chronic aphasia patients have been observed in our functional magnetic resonance brain     imaging studies to have excess brain activation in brain areas possibly related to language     on the right side of the brain (opposite side to where the stroke took place). It is expected     that suppression of activity in the directly targeted brain region will have an overall     modulating effect on the neural network for naming (and propositional speech) and will result     in behavioral improvement.   "
211666|NCT00614380|"     The primary objective of this trial is to assess the efficacy and safety of the fixed dose     combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5     mg (T80/A5) during long-term open-label treatment.   "
211633|NCT00608452|"     You may have a type of cancer associated with antineuronal antibodies in your blood.      Antibodies are substances made by the immune system. They are used by the body to fight     infections and other diseases. Antineuronal antibodies are antibodies that react with nerve     cells but they also react with some tumors. We believe that the immune system makes these     antibodies to fight the cancer. In some patients with these antibodies, the tumor is smaller     than in patients who have no antibodies. Sometimes, with a very strong antibody test,     patients may develop neurologic problems such as weakness, numbness or memory loss. One     purpose of this study is to determine if a patient with cancer and a positive antineuronal     antibody blood test has a smaller tumor and responds better to treatment than a patient with     cancer and a negative test. Another purpose of this study is to determine whether patients     with a positive antibody test develop neurologic problems such as weakness, numbness or     memory loss.      We will measure your blood for several different kinds of antibodies in addition to     antineuronal antibodies to determine if the presence of antibodies predicts prognosis, i.e.     smaller tumor and better response to treatment, or predicts the development of neurologic     problems.      No tissue samples are required for this study. However, if tissue or sputum is obtained by     your oncologist for diagnostic purposes, we will ask your doctors or the pathology department     to provide us with samples of these specimens. This will not involve any additional surgery     or discomfort to you.   "
211634|NCT00608465|"     The combination of high blood pressure and having central obesity is an increasing important     factor for heart disease in men and women. It can also lead to the early development of     hardening of the arteries and increased risk of a stroke. This study will analyze patients'     genetic make up to identify who may be at greater risk for heart disease and strokes in     relationship to high blood pressure and central obesity.   "
211635|NCT00608491|"     Heart failure is a serious condition in which the heart's ability to pump blood through the     body is impaired, often making a person feel weak or fatigued. When a person's condition     worsens to the point of hospitalization, that person is said to have acute decompensated     heart failure (ADHF). Abnormal kidney function in association with cardiac distress, known as     cardiorenal syndrome, is a common complication of heart failure and causes further medical     problems and need for hospitalization. While there are various effective treatments for heart     failure, more research is needed to determine the best treatment for targeting both ADHF and     cardiorenal syndrome. This study will compare the safety and effectiveness of ultrafiltration     versus standard medical drug therapy in improving renal function and relieving fluid buildup     in people hospitalized with ADHF and cardiorenal syndrome.   "
211636|NCT00608504|"     The purpose is to study how certain factors, including money, the amount of drug available     and the amount of work effort, affect opiate drug choice.   "
211637|NCT00608517|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood     transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor     can make an immune response against the body's normal cells. Giving tacrolimus and     mycophenolate mofetil before and after transplant may stop this from happening.      PURPOSE: To look at the ability of umbilical cord blood cells from one or two unrelated     donors to serve as a source of stem cells for people needing a bone marrow transplant.   "
211638|NCT00608530|"     This double blind, randomized, parallel groups, two arm, six month clinical trial. Patients     will have chronic low back pain of non-neoplastic origin. Patients will be randomized to one     of two conditions, either Cognitive Behavioral Training or Rogerian psychotherapy; both     conditions are home-based, telephone supported, with 10 hours of contact time delivered over     8 weeks.   "
211639|NCT00608543|"     Our target population will have been adequately treated with one of three selective serotonin     reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks     and continue to experience symptoms of depression that have prompted them to seek additional     treatment. Escitalopram, citalopram, and sertraline were selected for use in this study     because they are among the most commonly selected SSRIs and they are associated with a     reduced likelihood of drug-drug interactions with aripiprazole. After completion of the     screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15     mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician,     in conjunction with study participation. Symptom severity will be assessed on a weekly basis,     and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We     hypothesize that aripiprazole augmentation will be associated with reductions in symptom     severity, and with improved performance on measures of psychosocial and cognitive function.   "
211640|NCT00608556|"     This study will examine genetic material obtained from blood and tissue samples of patients     with congenital heart disease (CHD) and heterotaxy (an abnormality in the left-right     positioning of organs in the body, also called situs inversus) to gain a better understanding     of these disorders and of a lung disease called primary ciliary dyskinesia (PCD). CHD is     prevalent in patients with heterotaxy. It is believed that certain forms of CHD or heterotaxy     may have the same genetic origin as PCD.      Individuals 2 years of age or older who have a CHD or heterotaxy or both may be eligible for     this study. Participants undergo some or all of the following tests and procedures:        -  Blood tests, electrocardiogram (EGC) and chest x-ray.        -  Saliva collection: Subjects rinse their mouth with water, and then spit approximately          1.5 cc of saliva into a sterile container.        -  Buccal swabs: A small soft, toothbrush-like swab is rubbed on the inside lining of the          cheek to collect tissue samples.        -  Nasal tests to measure nasal nitric oxide levels and to obtain tissue samples from the          inside of the nostrils: For the nitric oxide level test, a rubber probe is inserted into          one of the nostrils until it fits snugly and comfortably. The subject then takes a deep          breath and then exhales all the way out through the mouth through a plastic device.          During exhalation, gas measurements are recorded on a computer. To obtain tissue          samples, a device is inserted in a nostril and scraped gently against the inside of the          nose.        -  Echocardiography: This ultrasound test of the heart uses sound waves to obtain pictures          of the heart. A small wand with a warm clear gel is moved around the chest to obtain the          images.        -  Abdominal ultrasound: This ultrasound test of the heart uses sound waves to obtain          pictures of the abdominal organs. A small wand with a warm clear gel is moved around the          abdomen to obtain the images....   "
211641|NCT00608569|"     Highly active antiretroviral therapy (HAART) has led to better health and survival rates     among people with HIV/AIDS. The purpose of this study was to measure the effect of trained     partner supervision when taking medication versus self-administered therapy in HIV infected     participants. These participants have had their first virologic failure on a non-nucleoside     reverse transcriptase inhibitor (NNRTI)-based HAART regimen and were starting a protease     inhibitor (PI)-based HAART regimen at study entry.   "
211643|NCT00608595|"     RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the     laboratory may help doctors learn more about changes that may occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how rectal cancer will respond     to treatment with celecoxib.      PURPOSE: This clinical trial is studying how well celecoxib works in treating patients with     early-stage rectal cancer.   "
211644|NCT00608621|"     The study is to evaluate the influence of physostigmine in the postoperative period in     intensive care patients considering pain quality, opioid consumption, hemodynamics and     mobilisation.   "
211645|NCT00608634|"     RATIONALE: Drugs used in chemotherapy, such as perillyl alcohol, work in different ways to     stop the growth of abnormal cells, either by killing the cells or by stopping them from     dividing. It is not yet known which dose of topical perillyl alcohol is more effective in     stopping the development of cancer in sun damaged skin.      PURPOSE: This randomized phase II trial is studying high-dose topical perillyl alcohol to see     how well it works compared with low-dose topical perillyl alcohol in treating patients with     sun damaged skin and actinic keratoses.   "
211646|NCT00608660|"     The purpose of this trial will certify the efficacy of using staging acupuncture and     moxibustion to treat Bell's Palsy   "
211647|NCT00608673|"     Discoid lupus erythematosus lesions are commonly treated with corticosteroids, but     corticosteroids may induce side effects such as thinning of the skin or scarring. Therefore,     an alternative medication with the same efficacy, but without the side-effects is sought     after.      Pimecrolimus is a newer drug specially designed to treat inflammatory diseases of skin. Its     efficacy in treating discoid lupus erythematosus has not been studied extensively yet.     However studies performed till now show promising results. Long-term topical use of this     medication has not shown any serious side-effects in other skin diseases.      In this study we aimed at comparing pimecrolimus efficacy with that of a common therapeutic     choice, betamethasone valerate 0.1% cream, to see if pimecrolimus can be used as an     alternative medication in treating discoid lupus erythematosus.   "
211648|NCT00608686|"     1. The major aims are to assess: (1) the relationship of basal and alcohol-induced     neurosteroid and GABA levels to the degree of acute alcohol intoxication in healthy male and     female volunteers; and (2) the effect of acute pregnenolone administration on the degree of     acute alcohol intoxication in these same volunteers. Specific hypotheses are:        -  Baseline serum levels of pregnenolone, pregnenolone sulfate (PS), dehydroepiandrosterone          (DHEA) and DHEA sulfate (DHEA-S) will be inversely correlated with the magnitude of          acute behavioral responses to alcohol (sedation, anxiolysis, amnesia, psychomotor          impairment and intoxication). That is, higher baseline levels of these neurosteroids          will be associated with lessened behavioral responses to alcohol.        -  Baseline serum levels of allopregnanolone, tetrahydrodeoxycorticosterone (THDOC),          androstanediol, androsterone and GABA will be directly correlated with the magnitude of          acute behavioral responses to alcohol. That is, higher baseline levels of these          substances will be associated with heightened behavioral responses to alcohol.        -  Acute alcohol ingestion, compared to placebo ingestion, will increase serum levels of          allopregnanolone and THDOC and plasma levels of GABA and will decrease plasma levels of          PS. (Effects on levels of other neurosteroids are not specifically predicted based on          animal data but will be examined in an exploratory manner.)        -  Acute alcohol-induced increases in serum levels of allopregnanolone and THDOC and in          plasma levels of GABA will be directly correlated with the magnitude of acute behavioral          responses to alcohol. Acute alcohol-induced decreases in serum levels of PS will be          directly correlated with the magnitude of acute behavioral responses to alcohol.          Correlations between alcohol-induced changes in other neurosteroids and changes in          behavior are not specifically predicted but will be examined in an exploratory manner.        -  Pregnenolone, compared to placebo, pre-treatment will antagonize the acute effects of          alcohol on the behavioral measures.   "
211649|NCT00608699|"     To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin     are co-administered as single doses to HVTs.   "
211650|NCT00608712|"     Phase IV, open-label, multicenter, non-randomized, with 2 non-comparative investigational     arms study, carried out in morbid obesity patients who had undergone gastric bypass surgery     for body weight reduction   "
211651|NCT00614159|"     Elective outpatient endoscopy for children can be safely performed under general anesthesia     with either propofol (1) or ketamine (2) infusions. Both infusions have an advantage over     general anesthesia with volatile agents because they do not require intubation. The goal of     both infusions is to have the patient breath spontaneously without reacting to the endoscopy     which is a noxious stimulus. Patient movement, stridor and vomiting are can interrupt the     procedure and increase overall OR time. Propofol also carries the added risk of causing     apnea. This side effect is not commonly seen with Ketamine. Our hypothesis is that Ketamine's     profile makes it a superior drug to Propofol for elective outpatient endoscopy because of     reduced profound intra-operative interruptions and faster recovery time. We plan a study of     pediatric patients ages 1 to 10 years old undergoing elective outpatient endoscopy. The     patients will be randomized to receiving either a Ketamine or Propofol infusion, and the     intra-operative interruptions will be documented by the anesthesiologist. The Post Anesthetic     Care Unit (PACU) time to recovery will be monitored and recorded by a third party.   "
211652|NCT00614172|"     The purpose of this study is to determine if partial breast proton therapy is effective     treatment for early stage breast cancer following lumpectomy.   "
211653|NCT00614198|"     A growing body of research indicates that dietary intervention excluding foods containing the     proteins, gluten and casein, from the diet of children diagnosed with an autism spectrum     disorder (ASD) may have a positive effect on behaviour and developmental outcome.      In this single-blind, randomised-controlled, matched-pair adaptive trial, we introduced a     gluten- and casein-free (GFCF) diet to a group of pre-pubescent children diagnosed with ASD     concurrently with an abnormal urinary profile. Following random allocation to a diet or non-     diet group, stage 1 of the study saw an intervention group follow the GFCF diet for eight     months initially - progressing to 12 months if required. A non-diet control group continued     with a normal diet.      Assuming significant changes for the dietary group on the various outcome measures of     behaviour and development, stage 2 of the study saw both groups assigned to GFCF dietary     intervention for a further 12 months when outcome measures were again assessed at study end.   "
211654|NCT00614211|"     The goal of this clinical research study is to compare the long-term outcomes of different     surgical methods for the treatment of cervical cancer. The long-term outcome of a total     abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study,     the laparoscopy will be done with or without robotic technology.   "
211664|NCT00614354|"     The purpose of this clinical trial is to study the ability of a radioactive drug called     Technetium Glucarate to detect whether the cause of chest pain in patients entering the     emergency department with no obvious signs of heart attack is due to a condition called Acute     Coronary Syndrome (ACS). The drug will be injected intravenously. After one or two hours the     patient will undergo an imaging procedure to detect if the drug has accumulated in the heart.     Uptake of the radioactive drug in the heart is indicative of reduced blood flow to the heart.   "
211665|NCT00614367|"     Optimise genetic screening of human embryos using higher resolution techniques   "
211655|NCT00614224|"     Aerobic treadmill exercise has been shown to improve walking, cardiovascular fitness and     thereby risk factor profiles in chronic stroke patients (Macko et al., Stroke 2005). The     proposed project is a randomized controlled trial in geriatric stroke patients with chronic     disabilities to investigate potential mechanisms of treadmill therapy. The hypothesis is     tested that 3-months of aerobic treadmill exercise induces structural brain plasticity and     reorganization. The outcome measures are walking ability, gait pattern, cardiovascular     fitness and brain morphology. This study will elucidate fundamental mechanisms of brain     adaptations linked to task-repetitive aerobic lower extremity exercise. These mechanisms will     not only lead to a better understanding but may also help to identify predictors of treatment     response.      40 patients aged over 60 years with lower extremity paresis after a first-ever clinical     stroke longer than 6 months prior to study inclusion will be recruited from: 1) The Geriatric     Rehabilitation Clinic at the Robert-Bosch Hospital in Stuttgart 2) the Dept of Neurology,     University Hospital in Tübingen. Subjects will be randomized to 3 months progressive graded     aerobic treadmill exercise training (TAEX; 3 times/week, duration 10-45 min) or an attention     control group (CON). Because we expect that localization and size of stroke affect therapy     outcomes, stratified randomization will be used to balance entry into groups.      We hypothesize that 3 months of treadmill gait training but not conventional care leads to     improvements of cardiovascular fitness and gait and to brain reorganization (structural     plasticity) in regions in which functional adaptations have been demonstrated using fMRI in     previous studies. The specific aims are:        -  To assess reorganization by comparing cortical thickness, cortical density and fiber          tract morphology before (time point 0), and after therapy (3 months) using T1-weighted          3D-MPRAGE images, voxel based morphometry and diffusion tensor imaging.        -  To correlate brain reorganization with improvements in walking velocity, and analysis of          gait patterns (parameters, swing time, stance time, gait symmetry).        -  To correlate brain reorganization with location and size of the index stroke lesion and          of diffuse white matter damage (subcortical vascular encephalopathy). Lesion and white          matter damage will be evaluated based on T2-weighted FLAIR sequences.   "
211656|NCT00614250|"     The primary objective of this study is to assess the activity of 4 escalating doses of     AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.   "
211657|NCT00614263|"     Examine levels of sedation required for patients to comfortably undergo colonoscopy using     propofol and if adjunct monitoring equipment promotes patient safety.   "
211673|NCT00614471|"     This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination     therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be     randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180     micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36     or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from     week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The     anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for     group 3, and the target sample size is 100-500 individuals.   "
211674|NCT00614484|"     The purpose of this study is to determine the effectiveness of proton beam radiotherapy     combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.   "
212259|NCT00631319|"     To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in     patients with Osteoarthritis (OA) Pain   "
211658|NCT00614276|"     The goal of this psychosocial research study is to learn whether a website program called     Tendrils: Sexual Renewal for Women after Cancer  may help female cancer survivors improve     their sex lives when used either as a self-help tool or in combination with brief sexual     counseling by a health care professional.      Objectives:      Sexual dysfunction is the most common long-term consequence of cancer treatment, affecting     half of survivors of breast and gynecological cancer and many women treated for other     cancers. Yet, few women get the help they need for sexual problems. Our primary objective is     to develop and evaluate a multimedia intervention program for women with cancer-related     sexual dysfunction. Tendrils: A Sexual Renewal Program for Women Surviving Cancer will: 1)     explain the causes of cancer-related sexual dysfunction; 2) offer self-help strategies to     prevent or overcome problems; 3) advise women on seeking appropriate medical help; and 4)     possibly serve as the core of a counseling program, along with a therapist manual. Tendrils     is aimed at a wide audience, from newly diagnosed to long-term survivors, across cancer     sites. Material will be presented with sensitivity to religious and cultural attitudes about     sexuality. Animations will illustrate anatomy and physiology. The software will let women use     Tendrils in a variety of formats: over the internet, on a CD-Rom, printed out, or as     downloaded digital video or audio on a handheld computer or media player. Video vignettes     will illustrate problems and strategies. Five female cancer survivors will host the program,     sharing their experiences.   "
211659|NCT00614289|"     This study is designed as a prospective, randomized, double-blind right/left comparison of     Epikeia coatings to improve hand dermatitis.   "
211660|NCT00614302|"     Data collection for better patient characterization in a highly treatment experienced     population. Studying the clinical practice for the treatment of HIV multiexperienced patients     in the real life.      The research will be divided into two phases:        -  The first phase intends to define and understand the clinical practice using a          questionnaire about general topics: definitions of multiexperienced patients and VL          failure, therapeutic strategies and behaviour in particular cases.        -  The second part of the research will collect the clinical data of double PIs failure          patients.   "
211661|NCT00614315|"     The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™     Delivery System.   "
211662|NCT00614328|"     The purpose of this research study is to learn about the use of a combination of two     medications, baclofen and naltrexone, for the treatment of alcohol dependence in men and     women ages 25-60 years old. Naltrexone is an FDA approved medication for treatment of alcohol     dependence. The most widely accepted idea for naltrexone's effect is that it reduces the     alcohol high, which decreases a desire to consume alcohol. As a result, alcoholic patients     treated with naltrexone are less likely to relapse to heavy drinking. Furthermore, naltrexone     treated patients drink fewer days and are more likely to maintain abstinence.      However, naltrexone does not have any effect on other symptoms that may contribute to relapse     such as anxiety, sleep problems and irritability. Baclofen, an FDA approved medication for     muscle spasms, may improve some of these symptoms.      Therefore, the purpose of the current study is to gather information on whether adding     baclofen to naltrexone is feasible and well tolerated.   "
211663|NCT00614341|"     To determine if pulsed electric field therapy reduces lower leg and foot pain associated with     diabetic neuropathy and lessens the need for medication.      The MedRelief device sends a sub-threshold electric signal through the skin using electrodes     as means of signal delivery. The signal or waveform, frequency and strength were created to     match the characteristics of signals the body generates to help natural healing.   "
211667|NCT00614393|"     This study will compare the safety and efficacy of dalotuzumab (MK-0646) in combination with     cetuximab and irinotecan in treating participants with wild type KRAS (wtKRAS) metastatic     colorectal cancer (CRC) compared to cetuximab and irinotecan alone.      The primary study hypothesis is that administration of dalotuzumab in combination with     cetuximab and irinotecan to participants with metastatic CRC expressing the wtKRAS genotype     improves Overall Survival OR Progression-free Survival compared to participants treated with     cetuximab and irinotecan alone.   "
211668|NCT00614406|"     The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor     will result in premature luteolysis (ovulation failure) in women.   "
211669|NCT00614419|"     To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using the Surgisis ES     soft tissue graft, as a mesh, and to compare it with the traditional Lichtenstein procedure     performed with polypropylene mesh.   "
211670|NCT00614432|"     The primary objective of this study is to compare blood loss resulting from surgical     termination of pregnancy up to 12 weeks gestation between women who are anticoagulated to     therapeutic levels and those who are not anticoagulated. This study is based on the     hypothesis that anticoagulant therapy does not increase intraoperative blood loss in women     receiving surgical abortions up to 12 weeks gestation.   "
211671|NCT00614445|"     The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg     and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of     pregnancy than a placebo.   "
211672|NCT00614458|"     The purpose of this research study is to see if HIV that persists despite current antiviral     therapy can be targeted by new treatments. We will see if adding Raltegravir (MK-0518) and     Valproic acid (VPA) to current ART can decrease the amount of latent HIV.   "
213349|NCT00645788|"     To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between     Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.   "
211675|NCT00614510|"     The purpose of this study is to demonstrate that the results achieved in the original pivotal     clinical investigation of 81 subjects from five clinical sites are generalizable to new     clinical sites that complete the staff training defined in the SynCardia Systems, Inc.     Training Manual and who enroll subjects who meet the intended use defined in the product     Instructions for Use.   "
211676|NCT00614523|"     The Data Monitoring Committee (DMC) for study 20060198 recommended that all subjects     discontinue treatment of study drug and continue to be followed for long term follow-up.     Amgen adopted the DMC recommendation.   "
211677|NCT00614536|"     The purpose of this observational study is to examine RSI (Reflux Symptom Index) and RFS     (Reflux Finding Score) by treatment period before and after rabeprazole treatment in     LaryngoPharyngeal Reflux Disease(LPRD) patients.   "
211678|NCT00614549|"     To evaluate, over 1 year period, the efficacy and safety of newly prescribed levetiracetam as     add-on treatment (POS, myoclonoc seizures in JME and PGTCS in IGE) or primary monotherapy     (partial onset seizures) in adult and paediatric patients within the approved age limits in     routine clinical practice in Czech and Slovak Republics, Hungary, and Romania.     Non-interventional study.   "
211679|NCT00614562|"     Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA     delivers assist to spontaneous breathing based on the detection of the electrical activity of     the diaphragm. We study the effect of NAVA in patients with critical illness associated     polyneuropathy / polymyopathy (CIP/M)   "
211680|NCT00614575|"     The primary objective of this investigation is to conduct a 12-week prospective survey in PD     patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as     this drug) in the routine clinical settings to determine the following items related to the     safety and efficacy.      i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the     investigation iii. Depressive symptoms during the investigation   "
211681|NCT00614588|"     This study will evaluate the accuracy of several thermometers and temperature changes during     surgery and immediately after surgery.   "
211682|NCT00614601|"     To assess the response for subjects with pancreatic cancer that have undergone surgical     resection and treatment with a vaccine given with or without chemotherapy and chemoradiation.   "
211683|NCT00614614|"     The purpose of the study is to characterize the immunogenicity & safety of a booster dose of     GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months     of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's     Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and     open-label for the booster phase.   "
211684|NCT00614640|"     The therapeutic DNA vaccine, DermaVir, represents an immunization strategy that targets lymph     node dendritic cells. Because of the high percentage of naive CD4 cells in children and     adolescents, the potential for effective new HIV-specific CD4 cell responses may be more     achievable in children than in adults. The primary purpose of this study is to evaluate the     safety and tolerability of DermaVir in children and young adults.   "
211685|NCT00614653|"     The goal of this clinical research study is to find the highest tolerable dose of     capecitabine, erlotinib hydrochloride, and bevacizumab that can be given in combination with     radiation to patients with pancreatic cancer.   "
211686|NCT00614666|"     The purpose of this study is to determine if nikkomycin Z is safe when administered at     different dose levels for 14 days. The study will also determine blood levels and urinary     excretion of nikkomycin Z in relation to dose administered. Patients with mild forms of     Valley Fever pneumonia will be eligible to participate and will be allocated to receive     treatment with nikkomycin Z (various doses) or a placebo. A secondary goal of this study is     to evaluate the effectiveness and dose response of nikkomycin Z in an exploratory analysis.   "
211687|NCT00614679|"     The primary objective is to investigate the ability of systemic intravenous antibiotic plus     antibiotic/anti-biofilm (i.e. N-acetylcysteine) lock catheter technique in eradicating     uncomplicated catheter associated bacteremia and salvaging the infected vascular catheter.     Secondary objectives include duration to clearance of bacteremia, future recurrence of     bacteremia, need for catheter removal and death.   "
211950|NCT00624741|"     This compassionate use study is designed to monitor safety in patients who have been doing     well on pergolide therapy, wish to continue treatment, and have not been able to tolerate     alternative treatments.   "
211688|NCT00614705|"     This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain     associated with post-herpetic neuralgia. Suitable patients will be randomized to receive     either PH-797804 or placebo for 4 weeks, during which time they will also record their pain     symptoms using various pain scales.   "
211689|NCT00614718|"     Comparison of two different approaches to address the problem of malfunctioning ICD-leads.     These leads consist of two parts. One that is used for detection of arrhythmias(and pacing if     required) (Pace/Sense) and a second part that is used to deliver therapy is needed     (Shock-coil).      The two approaches compared are:      Replacement of the entire lead in case of any lead malfunction versus placement of an     additional pace/sense-lead if the shock-coil of the exiting lead was still functional.   "
211690|NCT00614731|"     Atopic dermatitis (AD) is a skin disorder in which people often have swelling and skin     infections. People with this disease cannot receive the smallpox vaccine because it could     cause them to have a fatal reaction known as eczema vaccinatum (EV). Keyhole limpet     hemocyanin (KLH) is a protein that can be used to deliver vaccines to the body. The purpose     of this study is to determine a baseline immune reaction to KLH in people without AD. Once     this has been established, other studies can be designed to determine whether KLH can be used     to give vaccines to people with AD.   "
211691|NCT00614744|"     This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced     whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in     infants ≥ 36 weeks gestational age with hypoxic-ischemic encephalopathy will reduce the     incidence of death or disability at 18-22 months of age. The study will enroll 168 infants     with signs of hypoxic-ischemic encephalopathy at 16 NICHD Neonatal Research Network sites,     and randomly assign them to either receive hypothermia or participate in a non-cooled control     group.   "
211692|NCT00614757|"     The purpose of this study is to evaluate how often patients with hepatitis C infection have     abnormalities of sugar and fat utilization. Additionally we would like to find out if these     abnormalities of sugar and fat utilization are common in other liver diseases, or related to     being overweight.   "
211693|NCT00614770|"     In this study the investigators hypothesize that High Definition White Light colonoscopy and     narrow band imaging (NBI) will detect a higher number of adenomas compared to standard     definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp     histology compared to high definition colonoscopy and standard colonoscopy.      Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy,     high-definition white light colonoscopy and NBI.      Specific Aim 2 - To compare the number of adenoma detected per subject by standard     colonoscopy, high-definition white light colonoscopy and NBI.      Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard     colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface     mucosal and vascular patterns during the procedure.      Specific Aim 4 - To determine the inter-observer agreement between investigators for the     recognition of various polyp patterns   "
211694|NCT00614783|"     This is a pivotal study to determine the accuracy of a new device (SCOUT) in screening     persons for pre-diabetes or diabetes. SCOUT will be compared to the standard screening test     (Fasting Plasma Glucose), using the Oral Glucose Tolerance Test as the reference standard.      SCOUT uses a rapid, noninvasive, light-based technology to measure the concentration of     chemicals in the skin called advanced glycation endproducts (AGEs). Several studies have     demonstrated that AGEs accumulate in skin faster in individuals with poor control of blood     sugar.      Persons will be eligible for the study if they are 'at risk' for diabetes based on their age     and other risk factors as defined by the American Diabetes Association.   "
211695|NCT00614796|"     Chronic Obstructive Pulmonary Disease (COPD) is increasing in the Netherlands. COPD is     characterized by a deterioration of lung function, a lowering physical activity level and a     low state of quality of life.      The aim of this randomized controlled study is to investigate the effects of a structured     lifestyle program compared with usual care (in the first, second and third echelon) on the     physical activity level of COPD patients.      150 COPD patients (GOLD I-IV) will be included, aged between 40 and 80 years. In each echelon     25 patients will participate in a structured lifestyle program and 25 patients will be     treated with usual care.      In the structured lifestyle program, patients will be stimulated individually to enhance a     physically active lifestyle. The primary outcome parameter is daily physical activity (steps/     day) assessed with a pedometer.      According to the study protocol patients in the experimental group and the control group     participate in four measurement sessions distributed over 15 months. In each assessment a     physical fitness test, lung function and questionnaires are taken. Patients of the     experimental group participate in five individual counseling sessions and one telephonic     counseling.   "
211696|NCT00614809|"     This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and     toxicity of gefitinib in patients with asymptomatic advanced NSCLC who was benefitted by     first line chemotherapy. Patients with stage IV NSCLC who have one or more asymptomatic brain     metastasis who was benefitted by first line chemotherapy will receive oral gefitinib 250mg     once daily until disease progression or unacceptable toxicity. These patients' direct DNA     sequencing of tumor tissue EGFR exons 18-21 will be analyzed The response was evaluated by     RECIST criteria after the patient received gefitinib 6 weeks.If the patients present with     progress disease of brain metastasis after the therapy of gefitinib, the patients will     receive irradiation of brain metastasis.If the response is stable disease,partial response or     complete response,he will be examined by brain MRI every 12 weeks.   "
211697|NCT00614822|"     The purpose of this study is to look for an improvement in progression free survival with the     combination of bevacizumab, carboplatin and pemetrexed in patients with newly diagnosed     advanced/metastatic non small cell lung cancer. Overall survival and safety will also be     assessed.   "
211721|NCT00615134|"     This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon      + optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with     virological failure. Eligible patients will be randomized to recei ve either new optimized     treatment alone, or optimized treatment + Fuzeon 90mg s.      c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible     for a patient to receive several additional 3 month periods with F uzeon, in the case of new     virological failure. The anticipated time on study tre atment is 3-12 months, and the target     sample size is <100 individuals.   "
211698|NCT00614835|"     This is a pilot study of adjuvant therapy for patients with leiomyosarcoma of the uterus that     has been completely removed by surgery. Adjuvant therapy means that the tumor (the     leiomyosarcoma) has been completely removed by surgery; thus, giving further treatment now is     done in hopes of decreasing the chance that the tumor will come back (relapse or recur). The     main goal of this study is to show that this series of treatments is safe for patients with     your type of tumor.      In this trial you will be getting drugs that have been approved for use in some types of     cancer. In this study we wish to see whether the combination of two chemotherapy drugs,     docetaxel and gemcitabine can decrease the chance of your tumor, leiomyosarcoma of the     uterus, from coming back (relapsing). We will also be looking at the short-term side effects     and risks of the drugs given in this combination to patients with leiomyosarcoma that has     been completely resected (removed by surgery).      The combination of gemcitabine and docetaxel has been shown to be safe, and it has been shown     to decrease the size of leiomyosarcoma tumors in patients with leiomyosarcoma of the uterus     that has relapsed, or has continued to grow despite treatment with other chemotherapy drugs.   "
211699|NCT00614848|"     To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm     ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in     native coronary arteries 2.25-3.5 mm in diameter.   "
211700|NCT00614861|"     The purpose of this study is to survey pain management satisfaction in patients with     non-cancer pain.   "
211701|NCT00614874|"     Asthma is a common chronic disease characterized by airway inflammation and     bronchoconstriction. This study utilizes the drug rosiglitazone (Avandia)to treat the effects     of airway inflammation in patients with asthma.      The study will be conducted on 14 adult steroid naive patients with asthma. Patients with     qualifying pulmonary function testing values will be eligible for enrollment. Enrolled     subjects will be treated with rosiglitazone orally at 2mg dose for 4 weeks. Patients will be     reassessed and dosing will increase in 4 week increments up to 8mg.   "
211702|NCT00614887|"     Subarachnoid haemorrhage (SAH) may cause damage to the hypotalamo-pituitary-adrenal axis     (HPA) thus disturbing the hormonal response of these structures.      The aim of our study is to characterize the function of HPA-axis acutely and over time up to     three months in patients with SAH.   "
211712|NCT00615017|"     This is a double-blind, placebo-controlled, multi-center, dose-escalation study to assess the     safety, tolerability, Pharmacokinetics and Pharmacodynamics of single and multiple ascending     intravenous infusions of CytoFab (AZD9773) in adult patients with severe sepsis.   "
213450|NCT00647127|"     To compare the analgesic and anti-hyperalgesic effect of Buprenorphine and Fentanyl against     experimental pain in skin, muscle and bone. The study will be performed with healthy     volunteers.   "
211703|NCT00614900|"     The prevalence of an increased pulmonary blood pressure amongst patients with chronic     obstructive pulmonary disease (COPD)is unclear. So is the impact of abnormal pulmonary blood     pressure on symptoms. The aim of this study is to determine the prevalence of an increased     pulmonary blood pressure in 200 patients with COPD. Furthermore we will investigate if lung     function test results and blood tests can predict an increased pulmonary blood pressure, and     explore whether COPD patients with a high pulmonary blood pressure have more symptoms that     their co-patients.   "
211704|NCT00614913|"     This study is designed to evaluate the possible benefits and side effects of the use of     proton therapy for patients with hepatocellular carcinoma.   "
211705|NCT00614926|"     The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating     fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic     lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.   "
211706|NCT00614939|"     Saxagliptin is a new investigational medication being developed for treatment of type 2     diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally     impaired patients.   "
211707|NCT00614952|"     The abbreviated diagnostic sleep studies (RP), made at home and transferred telematically to     the sleep laboratory, are useful for the diagnosis of sleep apnea and due to a lower cost, it     could be an alternative to conventional polysomnography. Objectives: 1) Usefulness of     domiciliary study evaluated by percentage of patients diagnosed of SAHS compared with PSG and     agreement in the therapeutic decision. 2) Direct costs of patients included in the study.     Design: controlled, randomized, crossed and blind (320 patients) comparing PR made at home     with PSG, in patients suspicious of SAHS. The equipment transfer will be made by a transport     agency from home to home in order to be universal the access to this diagnostic model. The     file transmission with the raw data of the study will be made telematically by GPRS. If the     aims of the study reach an end there will be a considerable change in the clinical practice     making possible the international acceptation of domiciliary PR as diagnosis of SAHS and     adapting the diagnosis of this syndrome to the new technologies of communication. The     universalization of domiciliary PR would make possible that the diagnosis of SAHS could be     done in any patient and in any country with GPRS technology and a transport agency, that is     to say in all developed countries. As sleep apneas affect 5-7 million persons in Spain and     there is association between sleep apneas and cardiovascular risk, in the immediate future we     must evaluate this disease as we do today with the cholesterol determination. If our results     are as predicted, the primary care physician could start and in a lot of cases finish the     SAHS diagnostic process. This would simplify remarkably the diagnosis of SAHS and would     alleviate a lot the process cost all over the world.   "
211708|NCT00614965|"     This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the     second-line treatment of patients with stage IIIB/IV NSCLC   "
211720|NCT00615121|"     Peripheral artery disease is a disease that contributes to significant morbidity and     mortality of millions of Americans yearly. Very little is known about the pathophysiology of     atherosclerosis in peripheral artery disease. We plan to collect peripheral arteries and     muscle tissue from patients undergoing amputation for end stage peripheral arterial occlusive     disease. By extracting the RNA from these arteries and tissues and comparing them with RNA     expression from normal arteries, we hope to have a better understanding of the     pathophysiology of atherosclerosis in this setting. We aim to prove the hypothesis that a     novel gene expression pattern can be discovered by the successful extraction of RNA from     plaques from human peripheral arteries.   "
211709|NCT00614978|"     Objectives:      Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting     toxicities (DLT) of combining lapatinib and temozolomideSecondary - Obtain preliminary     information on the clinical anti-tumor activity of lapatinib plus temozolomide on brain     metastases secondary to HER-2 positive breast cancer including Objective Response Rate (ORR),     Clinical Benefit (CB) and Duration of Response (DR)      Methodology:      Phase I, single-centre, open-label, dose-escalation study of combining lapatinib and     temozolomide in HER-2 positive breast cancer patients with progressive brain metastases after     surgery or radiotherapy or radiosurgery      Treatment:      Temozolomide will be given orally for 5 days of every 28 days, at doses of either     100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at     either 1000mg/day or 1250mg/day or 1500mg/day.Sequential cohorts will be escalated in     increments according to the dose escalation scheme, and determined by dose limiting     toxicities.   "
211710|NCT00614991|"     To date, no study has investigated whether there is a drug interaction between the protease     inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL111242 is a randomized,     open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir     (APV) and raltegravir (RTG) pharmacokinetics in 48 healthy, HIV-negative adults after     administration of a 7-day regimen of RTG 400mg twice a day (BID) alone and after 14-day     regimens of unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/Ritonavir (RTV)     100mg BID, or FPV 1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent     RTG 400mg BID. Blood samples for drug concentration measurement will be collected over 12     hours at the end of each dosing period. Subjects will undergo a physical examination,     complete blood count (CBC) with differential, HIV test, hepatitis B/C test, liver function     test, renal function analysis, and lipid panel at screening, and all of these tests, except     those for HIV and hepatitis B/C, will be repeated at follow-up post-study. Adverse events and     adherence (by pill count and medication diary) will be assessed by the investigator/study     personnel at the end of each dosing period   "
211711|NCT00615004|"     A direct comparison between the results of surgery or somatostatin analogues (SSA) on     cardiovascular complication in acromegaly has never been performed.      Our objective is to investigate whether first-line surgery or SSA have a different outcome on     cardiomyopathy after 12 months. The design of the study is retrospective, comparative, non     randomized, because of ethical problems.      Setting University Hospital. All patients treated with SSA [either octreotide-LAR (10-40     mg/q28d), or lanreotide (30-120 mg/q28d); dosages up-titrated to control GH and IGF-I levels]     or operated on by transsphenoidal approach. For the purposes of this study only controlled     patients will be included.      Measurements Primary outcome measures were changes in left ventricular mass index (LVMi),     diastolic [early to atrial mitral flow velocity (E/A)] and systolic perform-ance [LV ejection     fraction (LVEF)]. Secondary outcome measures were reduction of total/HDL-cholesterol ratio,     as a cardiovascular (CV) risk parameter, improvement of glucose profile and pituitary     function, as indirect causes of CV improvement.      Expected results: SSA and surgery groups should have similar results in terms of improvement     of cardiomyopathy. However, recent data suggest that SSA reduce directly heart rate and     cardiomyocytes performance: clinical implications of these evidences suggest that SSA will     improve cardiovascular outcome more than surgery. Moreover, after surgery, replacement     therapy already stabilised or of new onset, has never been considered so far in this setting.   "
232966|NCT00903201|"     The purpose of this study is to determine whether the safety, tolerability and     pharmacodynamics of SB656933 in patients that have cystic fibrosis   "
211715|NCT00615056|"     The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or     FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying     tumor progression in the second-line treatment of patients with metastatic colorectal cancer     after failure of an irinotecan or oxaliplatin-containing first-line regimen.   "
211716|NCT00615069|"     The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER®     AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms   "
211717|NCT00615082|"     The primary goals of this exploratory/developmental (R21) study are to evaluate the     feasibility and acceptability of a MBSR intervention for caregivers of patients with     dementia, and to estimate the effectiveness of program outcomes on standardized measures of     perceived stress, psychological distress and caregiver burden. We will randomize 60     caregivers 1:1 to participate in: 1.) an intervention arm consisting of a MBSR program that     includes 8 weeks of group instruction in mindfulness meditation techniques followed by home     practice, or 2.) an active control arm consisting of a standard 8 week Community Caregiver     Education and Support (CESS) program.      We anticipate that caregivers will be interested in participating in the intervention, be     open to randomization, and have good rates of compliance with the program. It is also     expected that MBSR program participants will evidence a trend toward better outcomes than     CESS participants on primary outcome measures of perceived stress, psychological distress and     perceived caregiver burden.      Substudy The purpose of this proposal is to add a physiologic outcome sub-study to the     Balance project that will examine four biological markers correlated with stress in     caregivers participating in the study intervention. The Balance Study is a recently funded     NIH randomized controlled pilot study to evaluate the acceptability and feasibility of a     Mindfulness-Based Stress Reduction (MBSR) intervention for caregivers of patients with     dementia. Balance is randomizing caregivers (N=60) into equal numbers to participate in     either an intervention arm consisting of a MBSR program that includes eight weeks of group     instruction in mindfulness meditation techniques followed by home practice or an active     control arm consisting of a standard eight week community Caregiver Education and Social     Support (CESS) program. The specific aims of this study are to: 1) evaluate the feasibility     of adding physiologic markers to the Balance Study; 2) examine changes over time in     individual study participants on four biological markers correlated with stress including     interleukin 6 (IL-6), D-dimer, DHEA-S and telomere length; and 3) to examine preliminary     differences between MBSR and CESS groups on four biological markers. The addition of     physiologic outcomes to the Balance Study presents an emerging opportunity to increase the     competitiveness for our NIH R01 application.   "
211718|NCT00615095|"     The goal of this study is to find out if some people are more likely to get melanoma, a form     of skin cancer, than others. People respond to the environment in different ways. Some may be     born with genes that make them more likely to get this type of skin cancer. Genes are made up     of DNA. DNA damage is one of the first steps in developing cancer. Each person has many ways     to repair normal damage to their genes. Some people may have a lower level of this repair and     that may make them more likely to get cancer. Some genes are important for DNA repair. The     genes we want to test are thought to affect the rate at which DNA can be repaired. We also     want to find out if sun habits are related to these levels of DNA repair or genetic     mutations.   "
211719|NCT00615108|"     The purpose of this observational study is to survey the safety and effectiveness of the     product under the real condition of usual practice in Taiwanese hypertensive patients. During     the 8-week observation, the safety profiles and the clinical evaluation in between doses     through blood pressure (BP) measurement for overall effectiveness of telmisartan therapy will     be concluded.   "
211761|NCT00615667|"     Exploring the efficacy and safety of Tacrolimus on refractory nephrotic syndrome ; Acquiring     the experience of Tacrolimus on the treatment of refractory nephrotic syndrome in Chinese     patients.   "
211722|NCT00615147|"     The purpose of this study is to see if a blood test (D-dimer) is as precise as the CT scan     for the detection of clots.      A pulmonary embolism is an obstruction of the blood vessels in your lungs usually due to a     blood clot that travels to the lungs usually from the leg. Research has shown that the     results of a specific blood test (D-dimer) can be used instead of a CT scan to diagnose     clots. D-dimer is a valuable diagnostic marker in either detecting the presence of or     monitoring the progress of blood clots. D-dimer assays have proven to be a beneficial     diagnostic tool in the evaluation of patients with suspected pulmonary embolism (PE).   "
211723|NCT00615160|"     To evaluate the efficacy of PTK-ZK on metastatic melanoma either as a single agent treatment     or in combination with standard chemotherapy according to RECIST criteria. Further to     evaluate the safety and tolerability of PTK-ZK in patients with metastatic melanoma either as     a single agent treatment or in combination with standard chemotherapy   "
211724|NCT00615173|"     The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous     cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V).      To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy     of LN(III,IV,V).   "
211725|NCT00615186|"     The current study will investigate whether the addition of Neuradiab to surgery, radiation     and adjuvant chemotherapy (temozolomide) will improve the survival of patients with     glioblastoma and whether the drug regimen is safe.   "
211726|NCT00615199|"     This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to     severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be     tested will be more effective than placebo (inactive drug).   "
211727|NCT00615212|"     This study is meant to assess potential inhibitory effects of GSK376501 on CYP450 isoenzymes     3A4, 2C8, 2C9. subjects will receive probe compounds and systemic levels of these substrates     will be compared pre and post dosing of GSK376501.   "
211771|NCT00615810|"     This study aims to investigate whether patients switching their backbone from Kivexa to     Truvada, who already have raised total cholesterol prior to switching, have an improvement in     their total cholesterol after 12 weeks of treatment. If an improvement is demonstrated the     study aims to show whether this has a beneficial effect on the patient's overall     cardiovascular risk and long term prognosis.   "
211728|NCT00615225|"     We hypothesized that brain death is associated with an early systemic inflammatory response,     possibly combined with activation of apoptotic cell death, two events that may contribute to     induce rapid organ dysfunction. In this study of brain-dead donors and controls, we assayed     plasma cytokines and soluble factors, investigated plasma endotoxin levels as a triggering     factor for inflammation, measured ex vivo cytokine production by blood leukocytes to     determine whether immunosuppression occurred after brain death, and examined skeletal muscle     biopsies to look for evidence of inflammation and increased apoptosis in peripheral tissue.   "
211729|NCT00615238|"     Although exercise is widely regarded as a key component in obesity treatment, few individuals     seem able to adhere to exercise programs over time. In response, efforts have focused on     developing new approaches to physical activity that may appeal to sedentary overweight     persons. For instance, is has been shown that accumulating multiple short bouts of vigorous     exercise may enhance both exercise adherence and weight loss in overweight persons.     Accumulating moderate-intensity activity throughout the day may offer comparable health and     weight benefits as a traditional exercise program. Public health recommendations now include     the option of accumulating 30 minutes of moderate-intensity lifestyle activity for health and     well-being. While these two options offer a viable alternative to those who dislike or cannot     sustain continuous vigorous exercise programs, it is unclear whether the flexibility of     accumulating physical activity or the vigorous intensity of the exercise is responsible for     improved weight loss and long-term adherence.      The goal of this research is to extend our preliminary findings suggesting that moderate     intensity lifestyle activity is an important and viable alternative to traditional structured     vigorous exercise for obese dieting individuals. The primary specific aim of this project is     to compare the effects of three modes of exercise on long-term weight regain. Participants     will be 165 overweight men and women who are sedentary, but otherwise healthy. All     participants will receive the same 16-week behavioral weight loss program and will be     randomized to one of three exercise study conditions: 1) diet-plus-continuous bouts of     vigorous aerobic exercise; 2) diet-plus-short bouts of vigorous aerobic exercise accumulated     throughout the day; or 3) diet-plus-moderate intensity lifestyle activity accumulated     throughout the day. By varying both the intensity and duration of exercise bouts, we can     determine which type of exercise is associated with optimal outcomes one year later.     Additional questions of interest include:        1. Does mode of exercise influence exercise adherence?        2. Does mode of exercise improve cardiovascular risk profiles similarly in all three          conditions?        3. Does mode of exercise influence changes in body composition?        4. Does mode of exercise influence exercise enjoyment and exercise self-efficacy?   "
211730|NCT00615251|"     This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone     gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration     will be approximately 12 months and will involve ovarian suppression/stimulation protocols as     well as egg retrieval.   "
211731|NCT00615264|"     The purpose of this study is to determine if DiaPep277 can effectively protect the internal     production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the     immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the     immune system and is expected to prevent further destruction of the beta-cells by stimulating     regulatory responses, without causing immunological suppression.   "
211732|NCT00615277|"     The study investigates whether dietary intake of omega-3 long-chain polyunsaturated fatty     acids affects learning and mood of healthy young adults.   "
211733|NCT00615290|"     To obtain information on clinical practices for patients treated by Aptivus in real life   "
211734|NCT00615303|"     Sodium phosphate is one of the bowel preparation regimens for colonoscopy. However,     intraluminal gas can impair visibility during the examination. Simethicone is medication that     works by reducing the surface tension of air bubbles. We aimed to evaluate the effect of     simethicone in enhancing visibility and efficacy during colonoscopy.   "
211735|NCT00615316|"     We hypothesize that Guaraná, a native plant from the Amazon, might improve radiation-induced     fatigue in breast cancer patients undergoing treatment. In order to assess this, we     randomized patients to either guaraná extract or to placebo, switching the assigned treatment     mid-term through the radiation.   "
211762|NCT00615693|"     The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a     therapy for uveitis. Vision improvement and reduction in the swelling of retina will be     measured for the assessment of efficacy.   "
211764|NCT00615719|"     The purpose of this study is to evaluate whether 64-slice Computed Tomographic coronary     angiography is useful for rapid diagnosis or exclusion of significant coronary artery disease     in patients who present to the Emergency Department with chest pain.   "
211765|NCT00615732|"     The purpose of this study is to assess the effectiveness of qigong for the treatment of     chronic neck pain compared to exercise therapy and waiting list group.   "
211736|NCT00615329|"     Bone and soft tissue sarcomas are currently classified based upon light microscopy     supplemented by immunohistochemistry, but within many if not all of these tumor histologic     types, considerable heterogeneity exists not only in microscopic appearance but also in     biologic behavior and prognosis. Progress in the directed treatment of these tumors,     particularly the sarcomas, awaits characterization of the gene profiles for these tumors.     Orthopedic oncology researchers at Huntsman Cancer Institute at the University of Utah are     establishing a tumor bank for this purpose. The long term objectives of this work include:        1. creating tumor specific gene profiles to improve diagnostic accuracy        2. performing gene set validation for diagnostic predictive power        3. defining a discriminate gene list implicated in pathogenesis      The tissue procured under this protocol at SUNY Upstate Medical University will be limited to     excess soft tissue and bone tumor tissue from patients otherwise undergoing clinically     indicated procedures for diagnosis or treatment under the care of the local principal     investigator (PI) and will be forwarded to the central investigator, R. Lor Randall, MD at     Huntsman Cancer Institute for use in the characterization of the gene profiles of these     tumors.   "
211737|NCT00615355|"     The effect of treatment with narrow-band UVB 311 nm after transplantation of harvested     autologous epidermal cells on vitiligo lesions will be investigated.   "
211738|NCT00615368|"     The purpose of the trial is to determine if erythropoietin (EPO) can enhance cognitive     function during hypoglycaemia in patients with type 1 diabetes.      Patients with type 1 diabetes will receive one injection of EPO. Hypoglycaemia will be     induced 6 days after. Before (1 hour), during and after (1 hour) hypoglycaemia, the cognitive     function will be measured.   "
211739|NCT00615381|"     We hypothesize that in patients undergoing surgical treatment of unruptured intracranial     aneurysms, the increase in blood sugar as a result of surgical stress is detrimental to     outcome, as measured by blood levels of proteins associated with systemic inflammation and 7     day, 90 day, and 1 year postoperative neurologic and neuropsychiatric outcomes. Because     insulin itself is an anti-inflammatory agent, we anticipate that normalizing blood sugar     levels with insulin doses higher than normally produced by the body (i.e., supraphysiologic     insulin doses) will have a greater benefit on these outcomes than equally normalizing blood     sugar levels using normal insulin doses. Based on the results of this study, we will be able     to determine if a more laborious strategy to normalize blood sugar levels (i.e.,     supraphysiologic insulin therapy) offers any additional benefits to normal insulin dosing     strategies. In addition, we will obtain a robust assessment of postoperative neuropsychiatric     and neurologic outcomes of surgically repaired unruptured intracranial aneurysms that will     serve as the basis for future studies to decrease morbidity of these patients   "
211740|NCT00615394|"     Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating     ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This     study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up     to one year after the procedure.   "
211741|NCT00615407|"     Since 1980, the number of people in the United States diagnosed with asthma has increased     dramatically. Studying what causes and triggers asthma is an important part of understanding     and subsequently managing this disease. Although some have suggested that alcohol consumption     may affect asthma, little is known about how consistent alcohol use affects the amount of     inflammation present in the lungs and whether consistent alcohol use makes the airways more     narrow and stiff.      Participation in this study involves 2 visits in order to complete questionnaires, various     pulmonary function tests, as well as the collection of blood, urine, and exhaled breath     condensate specimens.      This study includes optional genetic and bronchoscopy substudies.   "
211742|NCT00615420|"     The primary hypothesis of this study is that regular topical oral application of Manuka Honey     will reduce the severity and duration of oral mucositis in patients who are undergoing     mucotoxic radiation therapy for cancer treatment.   "
211743|NCT00615433|"     Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical     study is designed to test the hypothesis that lurasidone is more efficacious than placebo.     The study will also evaluate the safety and tolerability of lurasidone as compared to     placebo.   "
211744|NCT00615446|"     This study assesses the maximum tolerated dose, overall safety and antitumor activity of     SU011248 in combination with gemcitabine in patients with advanced solid tumors   "
211745|NCT00615459|"     The study compared the 24-hour spirometry profile of indacaterol with that of placebo and     with tiotropium as an active control in patients with chronic obstructive pulmonary disease.   "
211746|NCT00615472|"     Parkinson's disease is a common progressive degenerative disease affecting 3% of all patients     over the age of 65. Given their age and frailty, these patients frequently require surgical     procedures with general anesthesia. However, after surgery, patients with Parkinson's disease     have longer hospital stays and a greater chance of not returning to independent living     compared to age-matched controls (Berman MF, unpublished data). In part, this is due to a     higher rate of post-operative delirium, which had an incidence of 60% in this population in     one study. There is anecdotal evidence from neurologists specializing in movement disorder     suggesting that there is also significant deterioration in parkinsonian motor symptoms and     cognition lasting for months or years following surgery and anesthesia. The basis for this     deterioration is unknown. We hypothesize that these problems are caused by particular     medications used during inhaled anesthesia for surgical procedures.   "
211763|NCT00615706|"     In the United States there has been a dramatic increase in the number of people who are obese     and in the number of people who have asthma. Both are considered serious public health     concerns. Several studies have shown that becoming obese or overweight can increase the risk     of developing asthma or can make asthma symptoms more severe and difficult to control. How     obesity affects asthma is not fully understood. This research study will examine whether     obesity affects the amount of inflammation that is present in the lungs of people with     asthma, and will also examine whether obesity leads to narrow and stiff airways.      Participation in this study involves 2 visits in order to complete questionnaires, various     pulmonary function tests, as well as the collection of blood, urine, and exhaled breath     condensate specimens.      This research study includes optional genetic and bronchoscopy substudies.   "
211783|NCT00615979|"     The goal of this study is to improve survival of battlefield trauma through ultrasound     telemedicine and remotely guided therapeutics.   "
211747|NCT00615485|"     Specific subgroups of children who survive treatment for childhood malignancies have been     shown to develop relative osteopenia following chemotherapy and are felt to be at risk for     developing osteoporosis later in life due to their inability to reach peak bone mass during     childhood. Based upon an earlier study in our department, the investigators reported     conclusive evidence that approximately half of survivors of pediatric solid malignancies are     at risk for these problems. However, the proportion of patients in our population that showed     osteopenia/osteoporosis was lower than that in other similar cross-sectional studies in solid     tumors such as osteosarcoma. The main difference between our report and the osteosarcoma     study was duration of follow-up, with ours being shorter. Longer follow-up may prove that a     larger proportion of our patients are affected. The purpose is to perform a longitudinal     follow-up study of bone mineral density using dual-energy X-ray absorptiometry (DXA) in adult     survivors of solid pediatric tumors that were previously studied as subjects in our original     cross-sectional study. The primary hypothesis is that the proportion of pediatric solid     cancer survivors with significantly lower bone mineral density (BMD) compared to established     age group controls will be increased with the additional time that has elapsed since the     original study despite the fact that the patients are young and would not normally be     expected to have osteopenia/osteoporosis at this age.   "
211748|NCT00615498|"     Current research shows that obesity greatly increases the risk of developing asthma. Although     the two conditions are clearly related, experts do not fully understand why they are linked.     Some researchers believe that hormones released in the fat cells (adipokines) play a role.     Others believe that excess weight pressing on the lungs triggers the hyperreactive response     in the airways that is typical of asthma.      The goal of the Asthma-Bariatric Surgery Study is to determine how weight loss affects lung     function and various biological parameters. Bariatric (weight loss) surgery refers to the     various surgical procedures performed to treat obesity. Specifically, this study is designed     to answer the following questions:        -  Does bariatric surgery help patients control their asthma?        -  How much asthma control can be achieved through weight loss?        -  How does weight loss influence lung function?      Participants in this observational research study will be asked to complete study visits at     enrollment, 1 month, 6 months, and 12 months. Questionnaires, pulmonary function tests, and     blood samples will be required at each time point.      This research study is observational only; it does not cover the cost of (or provide)     bariatric surgery. Optional genetic and bronchoscopy substudies are included as well.   "
211749|NCT00615511|"     Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative     symptoms and cognitive decline in schizophrenia. After four months the scores on the negative     symptom scale should be lower and the scores on the cognitive tests should be higher than     they were at study entry, compared with people who do not take any additional medication.   "
211750|NCT00615524|"     This study is being conducted to compare the efficacy and safety of exemestane alone or in     combination with pazopanib in postmenopausal women who have hormone receptor positive breast     cancer and have failed therapy with tamoxifen, anastrazole or letrozole.   "
211751|NCT00615537|"     This proposal is designed as a pilot study for the use of laser ablation for local control of     symptomatic (e.g compressive) benign thyroid masses in 20 patients.   "
211752|NCT00615550|"     The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel     in decreasing the preterm birth rate in a population of pregnant women with short cervical     length and at high risk for preterm birth.   "
211753|NCT00615563|"     The primary objective of this trial was to assess the presence of susceptibility to     tipranavir and other ARVs of the HIV-1 isolates in treatment experienced patients. The     secondary objective was to examine clinicians' use of HIV drug resistance testing in     treatment experienced patients currently failing a PI based HAART regimen.   "
211754|NCT00615576|"     This is a 4 to 6 week study to look at the safety and PK profile of SB656933 in healthy male     smokers   "
211755|NCT00615589|"     Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem     cell transplant - a procedure where the patient is treated with high dose chemotherapy and     then their own (autologous) stem cells are transplanted back into their body. Patients with     multiple myeloma and high risk genes, always relapse after an autologous transplant and often     die within two years from the time of their transplant. A different type of transplant     allogeneic) using donor cells, may work better for high-risk Multiple Myeloma, because the     donor cells may help kill the lymphoid cancer cells.      This study will investigate if a matched donor stem cell transplant using a newer, reduced     toxicity, chemotherapy (Flu-Bu4) is a feasible option for patients with high risk, Multiple     Myeloma.   "
211756|NCT00615602|"     This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense     docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive     breast cancer overexpressing HER2   "
211757|NCT00615615|"     Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to     evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial     onset seizures.   "
211758|NCT00615628|"     Researchers have previously demonstrated loss of heterozygosity in a region on chromosome     18q, associated with osteogenic sarcomas in bone affected by Paget's disease. The loci used     in this study are specifically described by those authors as showing loss of heterozygosity     in 6 of 7 affected families.   "
211759|NCT00615641|"     To determine how practical and precise different body composition methods are for measuring     body fat and lean tissue in young children and to determine if certain dietary factors and     physical activity patterns are related to body fat in children.   "
211760|NCT00615654|"     Objective: To investigate whether patients undergoing aquatic physiotherapy in groups improve     their functional capacity, by means of the distance covered in the six-minute walk test     (6WT), and to compare this with a control group. Methods: Forty women that had not been     practicing regular physical activity for one year were randomly allocated either to the Study     Group (SG) to undergo an aquatic physiotherapy program in groups applied twice a week,     including aerobic exercises, muscle strengthening and relaxation for 12 weeks, or to the     Control Group (CG), which did not do any physical activity. Both groups maintained their     treatment with medications. All patients underwent two evaluations: one at the start and the     other after 12 weeks.   "
211766|NCT00615745|"     A single tablet regimen (STR) of efavirenz, emtricitabine and tenofovir disoproxil fumarate     (tenofovir DF) is the first complete HAART that is offered as one tablet once a day. The     individual components of this HAART regimen have demonstrated efficacy and safety in HIV     treatment-naive patients and offer simplification that in turn may increase adherence and     improve clinical outcomes. This study aims to evaluate the effectiveness (efficacy, safety     and tolerability) of a STR simplification strategy in patients on HAART who have achieved     viral suppression in a real world clinical setting.   "
211767|NCT00615758|"     To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with     locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to     tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking     status and adenocarcinoma histology. Furthermore, erlotinib-sensitivity will be correlated     with the presence of EGFR mutations in exons 18, 19 and 21, in this population   "
211768|NCT00615771|"     We are examining whether pregnancy rates differ based on day of embryo transfer in patients     who replace all available embryos after an In vitro Fertilization (IVF) cycle. Patients must     be undergoing IVF treatment at Stanford University and patients will not receive compensation     for their participation (no medical costs covered or patient payment for participation).   "
211769|NCT00615784|"     The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class     drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant     to standard chemotherapy or are otherwise not eligible for conventional chemotherapy.     Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects     within normal and malignant cells that affect cell growth and cell death.   "
211770|NCT00615797|"     Children are at risk of developing an involuntary movement disorder after streptococcal     throat infections. Not all children are affected and the severity is individually variable.     Affected children have alteration in their behaviour and mood and can become quite     compromised in their activities of daily living. The condition is believed to be related to     the body having an over efficient immune response to the infection and some of the antibodies     made in response to the infection also attack centres in the brain controlling movement and     mood. Treating these children with immunoglobulins, which mop up the antibodies may reverse     or improve affected children. This study hopes to clarify this.   "
211774|NCT00615849|"     For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb     obliteration with pleural adhesive procedure is generally accepted as a standard. But     additional pleurodesis is potentially useless procedure on the parietal pleura for treating     visceral pleural disese. Furthermore, pleural symphysis could deteriorates normal pleural     physiology and cause chronic pain. According to our previous study, stapling resection of the     bulla without pleurodesis gave comparable result in recurrence comparing with articles with     additional pleurodesis. The purpose of this study is to evaluate surgical outcome of     thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure     is essential in the management of PSP.   "
211775|NCT00615862|"     Patients with alcohol use disorders are often cared for in the intensive care unit (ICU). We     estimate that close to half of the patients we care for in our ICU have alcohol use     disorders. One of the reasons that patients with alcohol use disorders are frequently cared     for in our ICU is because patients with alcohol use disorders are at higher risk of     developing infections. The medical term for infections is sepsis. When an infection develops,     patients with alcohol use disorders tend to get more severely ill compared to patients who do     not have alcohol use disorders. Patients with alcohol use disorders are also at higher risk     of dying when they develop severe infections.      The purpose of this study is to determine why patients with alcohol use disorders become more     severely ill when they develop infections. There are a number of reasons why this is     possible. One reason is that a hormone called cortisol is higher in individuals with alcohol     use disorders (who do not have infections). This hormone is also higher in patients who are     at increased risk of dying from severe infections. One of the aims of this study is to see if     cortisol levels are higher in patients with alcohol use disorders compared to those who do     not have alcohol use disorders.      Another reason why patients with alcohol use disorders are at increased risk of developing     infections is because their immune system is not functioning properly. A second aim of this     study is to see if certain markers of immune function are different in patients with alcohol     use disorders compared to patients without alcohol use disorders.      Patients with alcohol use disorders are also more likely to become confused when they are in     the ICU. This condition is called delirium. Delirium is marked by abrupt onset of altered     level of consciousness, disorganized thinking, and inattention that changes over time.     Delirium tremens is one form of delirium. About 80% of our ICU patients develop delirium, and     many patients who do not have alcohol use disorders develop the disorder as well. Patients     with alcohol use disorders who have high cortisol levels have a higher chance of developing     delirium compared to patients with normal cortisol levels. A third aim of this study is to     examine the relationship between delirium and cortisol in both patients with and without     alcohol use disorders.   "
211776|NCT00615875|"     The purpose of this study is to determine whether using an additional 48 hours of oral     naproxen, after other post-operative pain medications have been stopped, will be effective in     reducing opiate pain medication requirements and contribute to improved pain management.   "
211777|NCT00615888|"     Fast track programs have been introduced in many surgical fields to minimize postoperative     morbidity and mortality. Morbidity after elective open infrarenal aneurysm repair is as high     as 30%, mortality ranges up to 10%. In terms of open infrarenal aneurysm repair no randomized     controlled trials exist to introduce and evaluate such patient care programs.   "
211778|NCT00615901|"     CMF (cyclophosphamide, methotrexate, fluorouracil) is used to treat early stage breast     cancer. The combination, of these three drugs, has been used for approximately 30 years in     the treatment of breast cancer, and has been shown to be safe and effective. It is usually     given every 3 weeks. Doctors believe, based on other breast cancer trials, that giving this     type of chemotherapy in a shorter amount of time, every 2 weeks or sooner, instead of every 3     weeks, may be better. The purpose of this study is to test the safety of these drugs, given     every 2 weeks or sooner, to treat breast cancer. Other breast cancer chemotherapy regimens     have shown to be more beneficial when the drugs are given more frequently.   "
211779|NCT00615914|"     The survey is conducted to collect safety and effectiveness information on the use of     Pramipexole for long time of period in daily clinical settings in Japan.   "
211780|NCT00615927|"     Primary objective:        -  To evaluate activity of imatinib mesylate and hydroxyurea among patients with          progressive/recurrent grade II low-grade glioma (LGG) as measured by 12-month          progression free survival      Secondary objectives:        -  To evaluate progression-free survival (PFS), overall survival and objective response          rate among patients with progressive/recurrent grade II LGG treated with imatinib          mesylate plus hydroxyurea        -  To assess safety and tolerability of imatinib mesylate + hydroxyurea in this population   "
211781|NCT00615940|"     This randomized, double-blind, placebo controlled phase II trial is studying how well     capecitabine works when given in combination with WX-671 or when given alone in treating     patients receiving first-line therapy for her2negative metastatic breast cancer.   "
211782|NCT00615966|"     The purpose of this study is evaluate the safety and tolerability of Diannexin in kidney     transplant recipients.   "
211784|NCT00615992|"     The primary goal of this post marketing surveillance (PMS) study is to document the efficacy     of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended     in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course     of the disease.   "
211785|NCT00616005|"     Objective:      To determine activity of combo of Irinotecan + Temozolomide To further characterize any     toxicity associated w combo of Irinotecan + Temozolomide   "
211786|NCT00616018|"     Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by     processing it in the liver. During the processing, some of the acetaminophen may bind to     proteins in the liver. The protein-acetaminophen product is called an adduct. After a large     acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of     adducts are formed. However, we have found that lower levels may be formed even when people     take recommended doses. The purpose of this study is to measure the amount of adducts formed     when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.   "
211787|NCT00616031|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Nitroglycerin may help carboplatin and paclitaxel work better by making tumor cells     more sensitive to the drugs.      PURPOSE: This phase II randomized trial is studying how well giving nitroglycerin together     with paclitaxel and carboplatin works and compares it to giving paclitaxel and carboplatin     alone in treating patients with previously untreated stage III or stage IV non-small cell     lung cancer.   "
211788|NCT00616044|"     In major orthopaedic surgery of the lower extremities both continuous spinal anesthesia (CSA)     and combined spinal epidural anesthesia (CSE) are safe and reliable anaesthesia methods. Our     results suggest that both continuous spinal anesthesia and combined spinal epidural     anesthesia provide good surgical conditions with a low incidence of complications. The     sensory block level and hemodynamic changes were lesser with CSA.   "
212844|NCT00635713|"     The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of     ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast     cancer.   "
211789|NCT00616057|"     Obesity is constantly increasing, causing an important risk to develop diseases such as heart     disease, diabetes,... Some recent studies have shown that obese people present modifications     of colon microflora and a low-grade inflammation.      In our laboratory, we have demonstrated that the intake of fructans lessens dietary intake,     body weight gain, adipose tissue accumulation and steatosis in rodents. These effects lead to     an improvement of insulin resistance and hyperglycemia in diabetic rats and mice. Fructans     are also able to restore the microflora disturbed by a high fat diet and to prevent     endotoxemia. Moreover, studies have shown that fructans intake promotes satiety (Cani et al,     Diabetes 2007) and or decreases fat mass (Abrams et al, Journal of Pediatrics 2007) in     healthy human. An intervention study in obese patients is thus needed to study the effects of     fructans in the target population.   "
211790|NCT00616070|"     The purpose of this phase III study is to determine the safety and efficacy of difluprednate     in the management of inflammation following ocular surgery.   "
211791|NCT00616083|"     The purpose of this study is to learn about normal body composition (% body fat) during the     first six months of life in healthy breast-fed babies.   "
211792|NCT00616096|"     The purpose of this study is to determine whether immunoadsorption is effective in the     treatment of severe atopic dermatitis associated with excessively high serum IgE levels.   "
211793|NCT00616109|"     The goal of this study is to determine the progression-free survival rate in patients with     extensive-stage small cell lung cancer who had achieved complete response, partial response,     or stable disease with their previous platinum chemotherapy regimen, such as cisplatin or     carboplatin in combination with etoposide or irinotecan. In addition, the safety and     effectiveness of sunitinib will also be evaluated.   "
211794|NCT00616122|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and     methotrexate, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving sunitinib together with combination     chemotherapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib when     given together with cyclophosphamide and methotrexate to see how well they work in treating     patients with metastatic breast cancer.   "
211795|NCT00616135|"     A post-marketing study evaluating the transplantation of autologous fat augmented with     Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast     deformities post segmental mastectomy or quadrantectomy (lumpectomy).   "
211796|NCT00616148|"     The aim of this study is to evaluate the ability of a single oral dose of YKP3089 to abolish     or clearly reduce the IPS-induced photo-paroxysmal EEG response in photosensitive epilepsy     patients, and to measure the onset and duration of the effect. Several cohorts will be used,     to sequentially investigate different doses.   "
211797|NCT00616161|"     The purpose of this study is to determine the minimum effective dose of Istaroxime, in     patients requiring hospitalization for deterioration of chronic heart failure and left     ventricular systolic dysfunction. This goal will be reached by comparing the hemodynamic     effect of three different doses of the drug versus placebo. Efficacy will be measured as a     change in Pulmonary Capillary Wedge Pressure from pre-infusion to the last assessment at six     hours intravenous infusion.Secondary objectives will be to evaluate safety, tolerability and     efficacy on other main hemodynamic parameters, echocardiographic and echo-doppler     measurements, plus preliminary pharmacokinetics of the drug.   "
211798|NCT00616174|"     The purpose of this study to investigate whether using a special warming blanket during     Cesarean delivery helps maintain a normal body temperature in the baby when compared to     mothers that are not warmed (standard care at BC Women's Hospital). Doctors observed that     some babies have low body temperatures when they are born by Cesarean delivery. Since baby     temperatures are dependant on the temperatures of their mothers, we believe that keeping the     mother warm during surgery with the use of a special warming blanket that is filled with warm     air will result in the baby being warmer at birth.   "
211799|NCT00616187|"     A phase II open-label baseline-to-treatment trial was designed to evaluate the safety,     tolerability and efficacy of orally administered atorvastatin in patients with     relapsing-remitting multiple sclerosis (RRMS). Patients with at least one     gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were     eligible for the study. Patients are screened and enrolled in the outpatient clinic of the     Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3     monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg     atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9     compared to baseline. Secondary endpoints include other MRI-based parameters and changes in     clinical scores and immune responses.   "
211800|NCT00616200|"     The purposes of this study are to prospectively determine the effect of a very low     carbohydrate diet on quality of life and gastrointestinal symptoms in patients with     diarrhea-predominant irritable bowel syndrome (IBS-D); and to determine possible     physiological correlates of symptom improvement, as related to post-prandial     5-hydroxytryptamine (5-HT) release, weight loss and fiber content.   "
211801|NCT00616213|"     RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in     bone marrow or peripheral blood and may help the immune system recover from the side effects     of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given     together with G-CSF in treating patients with solid tumors.   "
211802|NCT00616239|"     This study will enroll 20 adult Hispanic women. Participants will apply 4% hydroquinone cream     twice daily to affected areas on the face for 14 weeks and half the face will be peeled with     20-30% salicylic acid every two weeks for a total of 4 peels. The first two peels will be 20%     salicylic acid and the second two peels will be with 30% salicylic acid. The purpose of the     study will be to evaluate the safety and efficacy of salicylic acid combined with 4%     hydroquinone versus 4% hydroquinone alone.   "
212845|NCT00635726|"     This phase II trial will study the effectiveness and toxicity of sequential high dose MVAC     followed by gemcitabine and cisplatin, as first line treatment in patients with locally     advanced or metastatic bladder cancer.   "
211803|NCT00616252|"     In HIV-infected women, the use of combination therapy with antiretrovirals (ARV) in pregnancy     prevents HIV related morbidity and mortality and prevents mother-to-child transmission of the     HIV virus.      Specifically, suppression of the virus to an undetectable level is important during the     delivery of the baby to minimize potential HIV exposure. In Sub-Saharan Africa, the use of     ARV combinations containing nevirapine is the cornerstone of current HIV therapy, due to an     affordable cost, availability in a fixed dose combination pill, and generic availability.     Maintaining the efficacy and preventing development of resistance against this agent by the     HIV virus is imperative, as second line therapies are often more difficult to obtain, are     more expensive, and present more challenges in drug storage in clinics and in the community.      Pregnancy adds another dimension to the challenge of treating women with HIV, as the     physiologic and metabolic changes can affect levels of antiretroviral agents in the body.     Though these changes are known to exist, few trials have evaluated the effect of these     factors on the pharmacokinetics of antiretroviral agents and their impact has yet to be     demonstrated.      We wish to evaluate if the physiologic changes that occur during pregnancy impact the levels     of stavudine, lamivudine, and nevirapine compared to those of a non-pregnant, HIV-infected     Ugandan female. These data are imperative to ensure adequate suppression of the HIV virus     throughout pregnancy.   "
211804|NCT00616265|"     The working hypothesis for the present study is that treatment with CPAP in patients with an     sleep apnea (IAH>15) and AHT-r is capable of producing significant reductions in     blood-pressure levels.      This hypothesis is supported by four proven findings:        1. -sleep apnea is an independent risk factor for arterial hypertension (1).        2. -The greater the number of RSD, the greater the loss of control over blood-pressure          levels (1).        3. -The prevalence of sleep apnea in patients with AHT refractory to treatment is very high          (11,12).        4. -Treatment of patients with sleep apnea and AHT-r with CPAP succeeds in significantly          reducing blood-pressure levels in the only (small-scale) studies undertaken to date          (14,15).      4. OBJECTIVES      Main objective:      To evaluate the effect of treatment with CPAP on blood-pressure levels in patients with AHT     refractory to medical treatment.      Secondary objectives:        -  To evaluate the effect of treatment with CPAP on the various elements assessed in BP          (systolic/diastolic; daytime/nighttime, etc) and the circadian profile          (dipper/non-dipper/raiser patterns; variability and homogeneity of blood-pressure          levels, etc) obtained during a 24-hour out-patient study (AMPA).        -  To analyze the related variables or subgroups of patients most affected by treatment          with CPAP.        -  To evaluate the effect of CPAP on the levels of some of the biological variables          involved in the pathogenesis of AHT-r (renin, angiotensin, aldosterone, atrial          natriuretic factor, etc).   "
211805|NCT00616278|"     The purpose of this study is to learn whether growth hormone being administered to children     with Chronic Kidney Disease is effective and if it has any side effects.   "
211806|NCT00616291|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects of a peptide vaccine in treating     patients with metastatic prostate cancer.   "
211816|NCT00622271|"     The purpose of this study is to utilize a group therapy adjustment and coping program at the     Children's Hospital of Wisconsin with patients who have Type 1 Diabetes Mellitus (T1DM) and     their parents within a typical clinical condition of patients who have been referred for     outpatient therapy services. To extend the previous literature on these types of peer and     family-based groups to include survey data as well as provider ratings, medical data, and add     retrospective and prospective data from baseline enrollment. To aid in establishing this     group therapy methodology as a promising evidence-based intervention within a population of     youths with T1DM and their families. The specific aim of this project is to enroll patients     and their families into either a treatment group or a wait list control group to receive the     group intervention to determine the impact of this peer and family-based group on improving     adjustment, coping, and functioning within diabetes.   "
211807|NCT00616304|"     Background: Mortality from severe malaria remains ~15% despite the use of the most rapidly     parasiticidal antimalarial therapy, artesunate. Adjunctive treatments may improve outcome.     Our overall goal is to determine if adjunctive treatment with L-arginine is safe and improves     outcomes in severe malaria. In studies to date, we have shown that L-arginine is safe in     moderately severe malaria, increases nitric oxide production and improves endothelial     function. We now propose to extend these studies to patients with severe malaria.      Aims: To determine the safety, preliminary efficacy, pharmacokinetics and pharmacodynamics of     L-arginine infusion in severe malaria.      Hypothesis: L-arginine will improve endothelial function, lactate clearance time and tissue     oxygen delivery compared to saline with no clinically significant adverse effects.      Methods: Based on previous pharmacokinetic modeling and simulations, we propose a phase 2A     randomised controlled trial of L-arginine vs saline in severe malaria, each given over 8     hours. If safety is demonstrated this will be followed by a phase 2B open-label study of     24-hour infusion of L-arginine in severe malaria with safety and preliminary efficacy     compared with the 8 hour infusions given in phase 2A.      The primary outcomes will be the improvement in endothelial function and lactate clearance in     patients given L-arginine infusion compared with those who received saline. Among the     secondary outcomes will be safety and the effect of L-arginine vs saline on tissue oxygen     delivery (NIRS).      Data from both phase 2A and 2B will be used to generate a pharmacokinetic/ pharmacodynamic     model.   "
211808|NCT00616317|"     The purpose of this study is to gather information about causes and treatment of     Antiphospholipid Syndrome.   "
211809|NCT00616330|"     This study will evaluate the efficacy and safety of a vaginal product compared with that of     other vaginal products in the treatment of vaginal infections.   "
211810|NCT00616343|"     The purpose of this study is to determine if Zonisamide is effective in reducing tremors in     patients with Essential Tremor.   "
211825|NCT00622401|"     The purpose of this study is to test the safety of an investigational Dendritic Cell/Tumor     Fusion vaccine given with IL-12 for patients with breast cancer.      RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body     build an effective immune response to kill tumor cells. Interleukin-12 may stimulate the     white blood cells to kill tumor cells. Giving vaccine therapy together with interleukin-12     may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-12     when given together with vaccine therapy and to see how well they work in treating women with     stage IV breast cancer.   "
211826|NCT00622414|"     This phase I trial is studying the side effects and best dose of aflibercept in treating     young patients with relapsed or refractory solid tumors. Aflibercept may stop the growth of     tumor cells by blocking blood flow to the tumor.   "
211827|NCT00622427|"     Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset     and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to     placebo. Secondary:We expect that Ramelteon will show statistically significant improvements     vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning,     including such specific items as focus and social and occupational functioning.   "
211811|NCT00616356|"     The investigators at Rockefeller University are doing this research to study how the immune     system responds to viruses and other infectious agents by using the yellow fever 17D vaccine     as a model. The YFV-17D vaccine is one of the safest and most effective vaccines known and     has been used to vaccinate humans against yellow fever virus (YFV) infection since the 1930s.     By studying how the human immune system responds to the YFV vaccine we hope to learn more     about the normal functioning of the immune system so that it might be possible to design new,     more effective types of vaccines to prevent important infectious diseases.      The reason for doing this research is:      Currently there is very little information about which factors determine the effectiveness of     the initial (primary) immune response to a foreign substance (antigen), such as a virus, that     person may be exposed to. There is also very little known about what determines how     effectively and for how long a person's immune system can react to the same antigen to     prevent another infection. Studies in animals have given us important information about how     the immune systems of other animals behave upon initial or repeated exposure to antigens,but     these topics have not been studied in detail in humans.      The following hypotheses will be tested:        -  The magnitude of the initial expansion of T lymphocytes (the clonal burst) specific          for the infecting virus determines the level at which memory T cell responses are          generated against the specific viral antigen and the duration of the memory T cell          response generated in the body.        -  The majority of CD8 T cells generated after immunization are yellow fever specific and          not bystander activation of non-specific cells.   "
211812|NCT00616369|"     This study is designed to investigate whether an association exists between certain     genes/protein levels and the development of various cardiopulmonary diseases. It is hoped     that this project will provide valuable insight into the understanding of these diseases.   "
211813|NCT00622232|"     The objective of this study is to determine the long term safety and tolerability of an     additional infusion of 10 billion VRX496 gene-modified CD4 T cells with a focus on evaluating     additional therapeutic benefits with respect to viral load and CD4 counts.   "
211814|NCT00622245|"     This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the     treatment of depression in patients with bipolar disorder.   "
211815|NCT00622258|"     This study assesses the tolerability, safety, efficacy and pharmacokinetics of everolimus in     Japanese patients. Everolimus is administered orally everyday to adult patients with relapsed     or refractory non-Hodgkin's lymphoma who have progressed despite standard therapy or for whom     standard systemic therapy dose not exist.   "
211817|NCT00622284|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to     preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient     glycaemic control   "
211818|NCT00622310|"     This project is aimed at determining whether an exercise-based weight loss intervention     causes a compensation in some component of energy expenditure such that the increase in     measured energy expenditure is less than the added exercise. The study will compare two     separate exercise interventions to determine if this is influenced by exercise intensity.   "
211819|NCT00622323|"     This is a prospective, non-interventional, post marketing surveillance study to determine the     proportion of patients experiencing an adverse event and a list of the experienced adverse     events, serious and non-serious, that would occur among Filipino patients with type 2     diabetes mellitus who are treated with exenatide who are taking metformin, a sulfonylurea or     a combination of metformin and a sulfonylurea but have not achieved adequate glycemic     control.   "
211820|NCT00622336|"     The study evaluated the safety of Lenalidomide monotherapy in participants with advanced     multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose     dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and     CC-5013-MM-010 due to the development of documented disease progression or the inability to     tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose     dexamethasone without grade 3 or 4 toxicity.   "
211821|NCT00622349|"     The purpose of this study is to determine if cisplatin-based chemotherapy,     cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison     to the combination gemcitabine-ifosfamide in patients with advanced NSCLC   "
211822|NCT00622362|"     The objective of this trial is to evaluate the clinical effectiveness of the administration     of a depigmented and polymerized allergen extract Dermatophagoides pteronyssinus in children     with allergic asthma due to this mite   "
211823|NCT00622375|"     The current study is being conducted to evaluate the relative bioavailability and single- and     multiple-dose pharmacokinetics of encapsulated mesalamine granules(eMG) in healthy subjects.   "
211824|NCT00622388|"     The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused     Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous     transplant   "
211828|NCT00622440|"     The purpose of this study is to find out if a Chinese herbal cream is effective in treating     HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal     intraepithelial neoplasia).   "
212092|NCT00619684|"     This phase II trial studies how well lenalidomide works in treating patients with progressive     or recurrent multiple myeloma after a donor stem cell transplant. Lenalidomide may stop the     growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the     immune system in different ways and stop cancer cells from growing.   "
211829|NCT00622453|"     Adult myotonic muscular dystrophy (Steinert's disease) is the most common inherited     neuromuscular disorder. Cardiac rhythm disturbances occur frequently in this disease state     and may be responsible for up to one-third of deaths. In this study, we intend to evaluate     the utility of non-invasive electrocardiographic screening methods and history in predicting     serious arrhythmic events.   "
211830|NCT00622466|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as paclitaxel, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving sorafenib together with     paclitaxel may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with     paclitaxel and to how well it works in treating patients with metastatic breast cancer.   "
211831|NCT00622479|"     The purpose of this study is to:        1. To elucidate the mechanism involved in the sorafenib-induced hypophosphatemia and          possible early effect of hypophosphatemia on bone mineral density        2. A secondary objective to assess the effect sorafenib treatment on evaluate left          ventricular function (LVEF) and Beta-type natriuretic peptide in plasma.   "
211832|NCT00622492|"     Rationale: Persistent pulmonary hypertension of the newborn (PPHN) is a life threatening     disease with a high mortality rate. Extracorporeal Membrane Oxygenation (ECMO) with     veno-arterial (V-A) or veno-venous (V-V) cannulation can provide a last treatment option.     Differences in circulatory changes between V-A and V-V ECMO concerning the course of PPHN and     organ perfusion are not known. Independent of the underlying disease, courses of ECMO runs     (with both systems) may differ a lot. Impairment of pulmonary and renal function and oedema     is frequently seen. Mechanisms that may play a role are not well understood yet. A better     understanding of hemodynamic changes in systemic and pulmonary circulation during treatment     of PPHN with ECMO as well as consecutive changes in organ perfusion and function will help to     develop more rationalistic treatment strategies to accelerate the recovery to a normal     neonatal circulation and shorten ECMO treatment. This will reveal positive effects for     patients as well as favourable effects on economic aspects for this very intensive treatment.      Primary objective: I.Evaluation of changes in pulmonary and systemic circulation during VV-     ECMO treatment and difference between V-V- and V-A ECMO Secondary objectives:II.Evaluation of     changes in cerebral, renal and mesenterial organ perfusion during ECMO treatment and     difference between V-V- and V-A ECMO III.Evaluation of hemodynamic changes during ECMO     treatment in relation to renal function and difference between V-V- and V-A ECMO     IV.Evaluation of BNP as diagnostic parameter regarding fluid homeostasis during ECMO     treatment and difference between V-V- and V-A ECMO Study design: observational; including two     cohorts. The first cohort consists of a group of patients that have been evaluated in a     former study, exclusively treated with V-A ECMO. The second cohort of patients will     prospectively include patients receiving V-V as well as V-A ECMO. A study period:2 and a half     years. All consecutively admitted patients for ECMO treatment at the department of     neonatology of the RUNMC will be evaluated for inclusion into the study. Study population:     Inclusion: Newborn infants with gestational age older than 34 weeks and reversible causes of     PPHN eligible for ECMO treatment. Exclusion:Newborn infants with congenital diaphragmatic     hernia, other congenital malformations and post-cardiosurgery.      Intervention: Standard treatment following the ECMO protocol of the department; evaluation at     standard intervals starting directly before cannulation for ECMO until 24 hours after     decannulation:registration of hemodynamic variables,parameters for organ perfusion using     echocardiography and Doppler sonography, blood and urine sampling and registration of     physiological and patient data.      Main study parameters/endpoints: Assessment of:Hemodynamic changes in pulmonary and systemic     circulation Secondary and other parameters/endpoints:      Assessment of:Changes in cerebral, renal and mesenterial blood flow, renal function in     relation hemodynamic changes,BNP in relation to fluid homeostasis   "
211833|NCT00622505|"     This study will evaluate the effectiveness and safety of a dosing method for zoledronic acid     in preventing skeletal complications in multiple myeloma patients who have been on an IV     bisphosphonate for about one to two years.   "
211834|NCT00622518|"     The purpose of this study is to determine if a commercially available homeopathic ear drop     preparation is effective in reducing symptoms in children 6 months - 11 years old with acute     otitis media. A total of 120 study patients with otitis media will be randomized to receive     homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is     postulated that children using the ear drops will have more rapid resolution of symptoms and     need fewer antibiotics than those randomized to not receive the ear drops.   "
211835|NCT00622531|"     The scope of the USE-BNP Trial is to investigate whether knowledge of BNP measurements, in     conjunction with clinical assessment, in the outpatient setting can guide the management of     therapy in patients with heart failure.   "
211859|NCT00623545|"     The purpose of this study is to find out how exenatide causes weight loss. Specifically, the     study is assessing how exenatide may change how people take in energy (energy intake), as     well as how it may effect how people use energy (energy expenditure).   "
211836|NCT00622544|"     The goal of the Microalbuminuria in Untreated Boys with Alport Syndrome study is to gather     information about critical clinical time points such as when patients with small amounts of     protein (microalbuminuria) in their urine progress to larger amounts (overt proteinuria).     Large amounts of protein in the urine is often an early sign of kidney disease.      Information needs to be collected in boys who are not taking medications known as angiotensin     converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in order to obtain     accurate data about the length of time between the onset of microalbuminuria and the start of     overt proteinuria. This new information will give physicians a better understanding of how to     treat patients with Alport syndrome.      The information we gather by conducting this study will aid in planning future clinical     trials because the identification of time points in disease progression, such as     microalbuminuria and overt proteinuria, could reduce the time necessary to show a clinical     benefit of a new treatment option.      The study has been approved by the University of Minnesota's Institutional Review Board.   "
211837|NCT00622557|"     A database has been established to track the outcomes of all cases performed in the     University Hospitals Department of Surgery in an effort to improve quality of surgical     performance and case management.      Specifically, the purpose of the database will be used as a quality improvement tool for     analyzing process and outcome measures and to accurately track cases performed by surgeons.   "
211838|NCT00622570|"     Objective: to assess the effectiveness of pentobarbital and thiopental to control raised     intracranial pressure (ICP), refractory to first level measures, in patients with severe     traumatic brain injury.      Material and methods: prospective, randomized open study to compare the effectiveness between     two treatments: pentobarbital and thiopental. The patients will be selected from those     admitted to the Intensive Care Unit with a severe traumatic brain injury (postresuscitation     Glasgow Coma Scale equal or less than 8 points) and raised ICP (ICP>20 mmHg) refractory to     first level measures according to the Brain Trauma Foundation guidelines. The adverse effects     of both treatments were also collected.   "
211839|NCT00623272|"     compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after     a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular     dysfunction   "
211840|NCT00623285|"     We hypothesize that the perioperative administration of pregabalin will significantly     decrease pain scores and post-operative opioid requirements for patients undergoing coronary     artery bypass grafting, and reduces the incidence of opioid-induced side effects such as     respiratory depression. This may reduce ICU admission and possibly abbreviate length of     hospital stay.   "
211841|NCT00623298|"     The present study is a pragmatic trial that investigates the efficacy and usefulness of two     treatment modules in a sample of Rwandan genocide orphans: Narrative Exposure Therapy (NET)     versus group-Interpersonal Psychotherapy (IPT). We used a half year baseline to measure the     treatment-induced changes. We hypothesized that there would be a greater reduction in     posttraumatic stress symptoms in the NET- than in the IPT-group and that IPT would be     superior to NET in the reduction of depression symptoms.   "
211842|NCT00623324|"     The purpose of this study is to demonstrate the safety, tolerability, efficacy and     pharmacokinetics of aplindore in patients with early stage Parkinson's Disease (PD) who are     not currently taking any dopamine agonists or who are able to wash off dopamine agonists for     14 days prior to baseline. Efficacy will be assessed using the UPDRS questionnaire including     part 3 of the UPDRS (Motor). their level of sleepiness on a standardized rating scale     (Epworth Sleepiness Scale) and their level of nausea daily.      Safety endpoints will include adverse events (AEs), clinical laboratory data, vital signs     (blood pressure, orthostatic blood pressure and heart rate), ECGs, physical examinations and     self rated scales.   "
211843|NCT00623337|"     Introduction: Just under four million infants die each year before reaching one month of age;     neonatal deaths now account for 38% of the 10.8 million deaths among children younger than 5     years of age. Tackling neonatal mortality is essential if the millennium development goal to     reduce by 2015 overall child mortality by two-thirds from its levels in 1990 is to be     achieved. Postnatal care for mothers and neonates in developing countries, particularly when     deliveries occur at home, is either not available or is of poor quality. Trained community     workers are considered by many to be pivotal to newborn care in the community, as they can     act as catalysts for community actions and also be providers of care.Reductions in neonatal     mortality have been slower in Sub-Saharan Africa than in any other region, and no evaluations     of the effectiveness and feasibility of home visits in reducing neonatal mortality have been     conducted.      Trial aim: To link with the Ghana Health Service to develop a feasible and sustainable     intervention to improve newborn care practices and careseeking during pregnancy and     childbirth, and to identify and refer very low birth weight and/or sick babies, through     routine home-visits by community health workers (CHWs), and by so doing reduce neonatal     mortality.   "
211844|NCT00623350|"     Noninvasive prospective multi-center study of an interactive 2-way, wireless or     site-independent, audiovisual telemedicine system designed for real-time remote examination     of acute stroke symptoms and deficits as a basis for treatment consultation and     recommendation.      Study aims (1) to determine the impact of a site-independent, remote, telemedicine     consultation system on decision making in the Emergency Department, regarding the decision to     treat or not to treat with thrombolytics; (2) to assess the numbers of patients who receive     thrombolytics and the time to treatment in patients evaluated by telemedicine versus     telephone only; (3) to assess the appropriateness of thrombolytic treatment decisions in     telemedicine versus telephone-only consultations; and (4) to assess the completeness of the     data collection in telemedicine versus telephone-only consultations.      60 patients in Arizona with acute presentation of stroke symptoms, per bedside practitioner     discretion (onset generally less than 12 hours and likely less than 3 hours)      Two arms: Video Camera/Telemedicine (Intervention n = 30) and No Video Camera/Telephone only     (Control n = 30)   "
211845|NCT00623363|"     The purpose of this study is to obtain preliminary information on the effect of piclozotan on     motor complications associated with Parkinson's Disease.   "
211860|NCT00623558|"     The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel,     cisplatin combination as induction therapy in locally advanced head and neck squamous cell     carcinoma.   "
211846|NCT00623376|"     Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in     people with spinal cord injury (SCI).      Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover     study. They received either nabilone or placebo during the first four-week period (0.5mg OD     with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week     washout, subjects were crossed-over to the opposite arm.      The primary outcome was the Ashworth scale for spasticity in the most involved muscle group,     chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale,     Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle     groups of each side of the body, and the Clinician's and Subject's Global Impression of     Change .   "
211847|NCT00623389|"     The purpose of this study is to evaluate a surgically implanted functional electrical     stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people     with various degrees of paralysis.   "
211848|NCT00623402|"     To evaluate the efficacy and safety of a combined treatment with Sorafenib (Nexavar®) and     pegylated interferon-α-2b (PegIntron®) in patients with malignant melanoma in stage IV.   "
211849|NCT00623415|"     Flupirtine, a non-opioid analgesic drug, that has been shown to have additional     neuroprotective functions, is given twice daily as an oral medication in patients with     relapsing remitting multiple sclerosis over a period of 12 months. Neuroprotection is     assessed by magnetic resonance imaging, magnetic resonance spectroscopy, optical coherence     tomography, and clinical examination.   "
211850|NCT00623428|"     This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin     combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C,     genotype 2/3.   "
211851|NCT00623441|"     The safety and efficacy of the Endeavor(TM) ABT-578 Eluting Coronary Stent System has been     assessed in a series of studies. The stent is coated with a proprietary drug compound that is     designed to reduce restenosis.      This prospective multi-center study has been initiated:        -  To document the acute and mid-term safety and overall clinical performance of the stent          system in a real world patient population requiring stent implantation.        -  To assess the event rate in patient subgroups with specific clinical indications and/or          vessel or lesion characteristics.   "
211852|NCT00623454|"     All Patients between 18 and 65 years are asked 6 month after investigation for chest pain or     palpitation at Cardiological Out-patient Clinic, Molde Hospital, about if they still have     symptoms of chest pain or palpitation. If they still have some of the symptoms they are     invited to participate in a coping course to learn a better way to deal with their symptoms.      The coping course consist of three sessions of cognitive behaviour therapy.   "
212093|NCT00619697|"     This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on     blood glucose control in type 2 diabetes.   "
211853|NCT00623467|"     This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called     Gadavist. The purpose of this study is to look at the safety (what are the side effects) and     efficacy (how well does it work) of Gadavist when used for taking images of the brain and     spine. The results of the MRI will be compared to the results of images taken without     Gadavist.   "
211854|NCT00623480|"     To evaluate the effect of secondary prophylaxis as compared to episodic treatment on bleeding     frequency (number of bleeds per year) and on joint damage.   "
211855|NCT00623493|"     Objective:      The ultimate goal of this project is to enhance the capacity of non-mental health clinicians     working in an Emergency Departments (ED) to recognize and initiate further evaluation of     children and adolescents at risk for suicide.      Aim 1: To re-validate the Risk of Suicide Questionnaire (RSQ), a screening tool that assists     non-psychiatric clinicians in rapidly detecting suicide risk in pediatric patients, in a     pediatric ED mental health population in the Children s National Medical Center (CNMC) ED.      Aim 2: To determine the utility of a suicide screening tool, a revised version of the Risk of     Suicide Questionnaire, to detect suicide risk in pediatric patients presenting to the CNMC ED     for non-mental health reasons.      Study population:      The study population includes all patients admitted to the CNMC Emergency Department, ages 10     to 21, during the data collection weeks of the study period. Both patients admitted for     mental health and non-mental health reasons will be included in the study.      Design:      This will be a prospective instrument development /validation study. During a designated     study week, all mental health patients and a random subset of non-mental health patients     admitted to the CNMC ED will be approached after their triage assessment. Following informed     consent and assent, a 17-item suicide assessment tool created for this research project     (RSQ-Revised), as well as a brief background questionnaire will be administered. These     questions will be validated against a gold standard suicide assessment questionnaire, which     will be administered to the subjects directly after the RSQ-Revised. The study aims to     develop a brief suicide screening tool to be used at triage for all patients entering the ED.      Measures      Measures include the proposed 17-item screening questionnaire and a gold standard assessment     of suicidal ideation in adolescents, the Suicide Ideation Questionnaire (SIQ).   "
211856|NCT00623506|"     Mild traumatic brain injury (TBI) is common among veterans who have served in OEF/OIF     (Operation Enduring Freedom in Afghanistan/Operation Iraqi Freedom) and other theatres.     Delayed symptoms may occur following TBI, including cognitive symptoms (impaired attention,     processing speed, executive functioning), as well as behavioral symptoms such as anxiety,     depression, and irritability (Fann et al. 2004; Holsinger et al. 2002). Neuroactive steroids     have neuroprotective effects in rodent models of TBI (Djebaili et al. 2005; Djebaili et al.     2004; He et al. 2004; Pettus et al. 2005; Roof et al. 1997) and the neuroactive steroid     pregnenolone and its sulfated derivative also markedly enhance learning and memory in rats     (Akwa et al. 2001; Flood et al. 1992; Flood et al. 1995; Vallee et al. 1997; Vallee et al.     2003). In humans, reductions in pregnenolone (George et al. 1994) and its GABAergic     metabolite allopregnanolone (Uzunova et al. 1998) have been associated with depressive     symptoms. Pharmacological intervention with the neuroactive steroid pregnenolone could     therefore result in a multi-targeted treatment approach, potentially improving cognitive     deficits as well as anxiety and depression symptoms following TBI.   "
211857|NCT00623519|"     To investigate the global incidence of the endometrial changes in postmenopausal women     receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.   "
211858|NCT00623532|"     Few previous studies have explored the effects of mind body approaches on health-related     quality of life (HRQoL) in frail elderly. Cognition and action are an inseparable whole while     functioning. A new intervention-based approach using familiarity based movements and a     non-judgmental approach was labeled cognition-action. The investigators aimed to explore     the effects of two different mind-body exercise types on (HRQoL) in frail institutionalized     elderly.      The investigators' main hypothesis is that adaptated physical activity in frail     institutionalized elderly can improve HRQoL.   "
211861|NCT00623571|"     Aim of the study was to evaluate the efficacy of hospital-at-home treatment compared with     inpatient care in selected elderly patients with acute exacerbation of chronic heart failure     (CHF).   "
211862|NCT00623584|"     The goal of this clinical trial is to compare the quality of corneal grafts cultured in a     serum-free culture medium with a defined composition versus corneal grafts cultured in a     standard serum supplemented culture medium transplanted in patients with decompensated     corneal dystrophy   "
211863|NCT00623597|"     This single arm study will assess the pharmacokinetics, safety and activity of saquinavir     (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination     with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6     years. Patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2.5mg/kg     or 3.0mg/kg (dependent on body weight), and a background antiretroviral regimen. If drug     exposures are found to be dissimilar to those previously seen in older children and adults,     or are associated with toxicities, subsequent dose adjustments will be made. The anticipated     time on study treatment is 3-12 months, and the target sample size is <100 individuals.   "
211864|NCT00623610|"     To examine whether temporary immunosuppression with ATG, tacrolimus and MMF allows prolonged     survival of beta cell allografts in type 1 diabetic patients with early chronic complications     of diabetes.   "
211865|NCT00623623|"     This study aims at evaluating, in a proof of concept approach, the outcome of patients     presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in     either a pre-hospital setting or community hospital emergency room without a PCI facility.     Following randomisation a strategy of early tenecteplase and additional antiplatelet and     antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary     intervention as appropriate (or by rescue coronary intervention if required) in Group A will     be compared to primary PCI performed according to local standards in Group B.      The study is exploratory in nature and will examine this medical question. The efficacy and     safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before     30 days following randomisation will be evaluated.      All clinical endpoints of main interest will be assessed as single or composite endpoints for     evaluation of the trial objective. All statistical tests are of exploratory nature based on     descriptive p-values for formal statistical hypotheses generation.   "
211866|NCT00623636|"     This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in     adult migraineurs. Subjects will self administer study drug in the outpatient setting.   "
211867|NCT00623649|"     The purpose of this study is to determine whether a 3-day course of therapy with orally     administered VCH-916 given at different dosages can effectively reduce the amount of     circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis     C-infection. This study will also evaluate the safety and tolerability of treatment with     VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma     at various time points during the treatment period.   "
211868|NCT00623662|"     The goal of the study is to determine whether intravenous glucose administration before liver     resection preserves hepatic glycogen resulting in improved hepatic metabolic function after     the operation.      We further investigate whether the benefit of avoiding preoperative fasting is more     pronounced in patients undergoing more extensive liver resection.   "
211869|NCT00623675|"     Researchers want to find out if urine heavy metal levels are changed in persons who use     Mineralox Basic C™ (Mineralox). Mineralox is a zeolite (clinoptilolite) in combination with     Vitamin C. Zeolites are natural supplements (nutraceuticals) that work at the cellular level     to remove heavy metals and toxins that are accumulated in every day life safely from the body     through the urine. The study doctor will give Mineralox to 20 people in this study to see if     it helps with the heavy metal removal from the body.   "
211870|NCT00623688|"     This study will be conducted as a randomized, double blinded, controlled trial. The control     group will receive albuterol delivered by a nebulizer along with placebo treatments delivered     by a metered dose inhaler (MDI) with a spacer +/- mask. The experimental group will receive     albuterol delivered by MDI with spacer +/- mask along with placebo treatments given by a     nebulizer. Parents, participants, study personnel, nursing staff, and respiratory therapists     will not know the treatment assignments of participants. The primary outcome will be changes     over time in an asthma severity score, the Clinical Asthma Score (CAS) (Parkin et al. 1996).     The secondary outcomes will be total number of albuterol treatments received in the hospital,     time it take to give treatments, time till subjects' albuterol treatments are given at four     hour intervals, and the costs of the two types of treatments. The study hypothesis is that     albuterol delivered by metered dose inhaler with spacer is non-inferior to albuterol     delivered by nebulizer in the treatment of children hospitalized with moderate to severe     asthma exacerbations.   "
211871|NCT00623701|"     Efficacy and Safety from a high-dosed sublingual grass pollen preparation   "
211872|NCT00623714|"     The primary goals of this study will be to implement innovative processing and detection     assays to qualify induced sputum measurements of markers of allergen-induced airway     inflammation. The results of this study are intended to form a platform to be used in the     clinical development of novel asthma therapeutics.   "
211873|NCT00623727|"     A study to assess treatment with a new formulation of recombinant factor VIII reconstituted     with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can     prevent bleeds in subjects with severe haemophilia A.   "
211874|NCT00623740|"     There is increasing evidence linking a fetal and early neonatal systemic inflammatory     response syndrome to the subsequent development of bronchopulmonary dysplasia (BPD) and white     matter injury (WMI) in very preterm infants. Babies with evidence of adrenal insufficiency     early in life may not be able to control the inflammatory response and are thereby more     likely to develop BPD than babies who do not show such evidence of inflammation. We designed     a randomized controlled trial to test the hypothesis whether very preterm babies at high-risk     of BPD, treated with low doses of HC during the first 10 days of life, are more likely to     survive without BPD at 36 weeks of post-menstrual age (PMA), compared to babies treated with     placebo.   "
211904|NCT00624130|"     The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a     marketed comparator.   "
211905|NCT00624143|"     Hypothesis:Oral Voriconazole will be as effective as intravenous Amphotericin B as antifungal     prophylaxis in induction of acute leukemia (ALL, AML) in pediatric patients, with less     toxicity and more convenience.   "
211875|NCT00623753|"     Vaccines have been very successful in preventing viral infections such as hepatitis B and the     measles. Viral vaccines work by causing a person's immune system to make cells that will work     against the virus. Due to the success in treating other viral infections, scientists are     trying to develop a vaccine for human immunodeficiency virus (HIV). HIV infection is the     cause of acquired immune deficiency syndrome (AIDS). AIDS is one of the most serious viral     infections we know.      This is a research study to evaluate the safety of a possible vaccine against HIV.     Researchers want to determine that a person's immune system can respond to the HIV before he     or she is exposed to it. Therefore that person may be able to be protected from infection     with HIV.   "
211876|NCT00623766|"     To assess the response of melanoma with brain metastases to ipilimumab treatment while     maintaining acceptable tolerability.   "
211877|NCT00623779|"     The purpose of this study is to assess the safety and tolerability of AZD0837 in patients     with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for     up to 3 months.   "
211878|NCT00623792|"     The purpose of the trial is to determine whether a preoperative lifestyle intervention     (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related     parameters prior to bariatric surgery and improve short-term postoperative outcomes.   "
211879|NCT00623805|"     This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin     (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin +     Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of     2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda     + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease     progression. Xeloda was administered at a dose of 1000 mg/m^2 orally twice a day on days 1-14     of each cycle, oxaliplatin at a dose of 130 mg/m^2 intravenously (iv) on day 1 of each cycle,     and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.   "
211888|NCT00623922|"     The purpose of this study is to explore the effect of patient education (PE) in patients with     arthritis. PE has become a task that is dictated by law in Norway, and is increasingly used     as an element in the treatment of patients with chronic complaints. Our hypothesis is that      - PE delivered as group education, followed by an individual nurse consultation increases the     patients wellbeing an ability to cope with the disease.   "
211926|NCT00624416|"     The purpose of this study is to test whether injected medications will increase the amount of     fat released by a fat cell. We will compare prednisolone (a synthetic cortisone) combined     with isoproterenol (a drug given for asthma) versus using isoproterenol alone. We will also     test if injections of isoproterenol and prednisolone will shrink the size of lipomas, which     are benign fatty tumors.   "
211880|NCT00623818|"     This study, conducted at the National Institutes of Health (NIH) and at Walter Reed Army     Medical Center (WRAMC), will explore the phenomenon of phantom limb pain (a continued feeling     of pain in an amputated limb) and will use functional magnetic resonance imaging (fMRI) to     investigate the effect of mirror therapy on phantom limb pain.      Right-handed people between 18 and 75 years of age who are in the WRAMC Military Amputee     Research Program and healthy control subjects may be eligible for this study. Participants     undergo the following procedures:      Amputees        -  Questionnaires to assess strength of handedness and footedness and pain perception.        -  Mirror therapy for phantom limb pain five times a week for 4 weeks in 15-minute          sessions.        -  MRI and fMRI scans before starting mirror therapy, after 2 weeks of therapy and after 4          weeks of therapy. MRI uses a magnetic field and radio waves to image brain tissue. The          subject lies on a table that can slide in and out of the scanner (a metal cylinder). The          structural MRI scan lasts about 30 minutes. For fMRI, the subject performs tasks while          in the scanner in order to show changes in brain activity involved in performing those          tasks. Subjects are shown pictures of feet and other body parts, are asked to move their          feet, and receive tactile (touch) stimulation of the foot or other body parts.      Control Subjects      One group of control subjects undergoes a single fMRI procedure. A second group of control     subjects undergoes the same sequence of three fMRIs over the same time period as the amputee     subjects. None of the control subjects undergo mirror therapy.   "
211881|NCT00623831|"     This was a phase 1, open-label, multiple dose, single-arm study. The mixed bacteria vaccine     (MBV) was administered at a starting dose of 250 EU (1 µL) and escalated in each subject to a     dose inducing the desired pyrogenic effect, defined as a body temperature of 38°C to 39.5°C.     The primary objective was to determine the safety profile of MBV in subjects with malignant     tumors that expressed the NY-ESO-1 antigen and to identify the dose that induced the desired     pyrogenic effect. Secondary objectives were to evaluate the immunological effects and tumor     response of subjects following vaccination.   "
211882|NCT00623844|"     Objectives: The PAKT project shall evaluate the effects of an exercise intervention in     kindergarten combined with an educational training of parents and kindergarten teachers on     behavior and health status of children.      Study design: Baseline measurements were performed on more than 700 kindergarten children     aged 43-67 months in May to July 2007. The kindergartens are located in and around Wuerzburg     in Germany. Kindergartens were then randomized in an intervention (21 kindergartens) and a     control (20 kindergartens) group. The intervention group offers a daily exercise class     lasting at least 30 min. Parents and teachers of the children in the intervention program     receive educational training. In addition, the children have activity homework involving the     entire family. The control kindergartens keep their routine. Follow-up measurements of     physical activity (actigraph), motor skills, body mass index, skinfold thickness, and blood     pressure take place in January/February 2008, June/July 2008, and September/October 2008. The     number of accidents in and outside of the kindergartens and the number of children missing     the kindergarten due to infections are monitored continuously.      Use of results: If the PAKT program should proof effective, the results will be published in     scientific journals and made public using the press. With the help of the GEK, the program     will then be implemented nationwide in kindergartens.   "
211883|NCT00623857|"     The purpose of this study is to determine to what extent supplementation with zinc and other     micronutrients are efficacious in preventing malaria in young Tanzanian children.   "
212103|NCT00625924|"     The goal of the study is measure breast sensations after breast surgery. The results of this     study will help surgeons better understand breast sensations and may improve the way surgery     is done.   "
211884|NCT00623870|"     This study will determine the maximum tolerated dose of RO5045337 and the optimal associated     4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with     hematologic neoplasms. A first cohort of patients will receive the starting dose of     20mg/m2/day orally, once daily for 10 days in each 28 day cycle. Subsequent cohorts of     patients will receive dose escalations, and possible changes in dosing schedule, based on     tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. Different     formulations of RO5045337 will be tested and the food effect evaluated. The anticipated time     on study treatment is until disease progression or intolerable toxicity.   "
211885|NCT00623883|"     We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their     prevention would correlate with cancer risk and their elimination would reduce that risk. In     this study we wished to (1) establish the feasibility of stain-enhanced magnification     colonoscopy, (2) determine whether colorectal cancer is asociated with increased numbers of     ACF, and (3) investigate the natural history of ACF and the durability of their elimination.   "
211886|NCT00623896|"     The method of ECG recording with the use of three bipolar leads A (anterior), D dorsalis) and     J (or I - inferior) was introduced in 1938 by German electrophysiologist W. Nehb. Being     positioned on the chest in the immediate proximity to the heart, and being aligned to the     anatomic position of the heart, these leads are very sensitive and allow accurate diagnostics     of different heart conditions. All the active leads are placed on anterolateral plane of the     chest wall requiring little anatomical window making this technique convenient for express     diagnostics using compact electrocardiographic devices without any loss of valuable     information.      Active electrodes are located on the chest in the following order: 1st- red standard     electrode placed in the second intercostal space to the right from sternum corresponding to     V1 for standard 12-lead ECG recording, 2nd- green standard lead placed in the position     corresponding to V4; 3rd- yellow in the position V7. Then ECG recorded as if in the I     standard lead would be defined as Nehb's D, which records the potential on the posterior left     ventricle wall; II standard lead would produce Nehb's A which corresponds to the potential on     the anterior wall of the left ventricle, and III standard lead would record Nehb's J, which     reflects the potential on the diaphragmatic surface of heart.      Been simple and informative, this ECG recording modality may be applicable for usage with     compact portable cardiographer devices for express diagnosis in different situations and may     allow faster and more adequate outpatient response in the case of emergencies.      Nehb 3 leads ECG can provide the clinician with portable, reliable, comprehensive and     constant ECG monitoring and by this facilitate rapid diagnosis and treatment of STEMI.   "
211887|NCT00623909|"     The purpose of this study is to demonstrate the safety of the AvicennaTM class IV laser for     application over the skin of human subjects. In addition, we seek to measure the     effectiveness and utility of this class 4 laser therapy in the treatment of post-thoracotomy     pain syndrome.   "
211889|NCT00623935|"     The prognosis for older individuals with acute myelogenous leukemia (AML) has been     historically poor, with 2 year disease-free survival rates < 20% reported. Younger patients     with AML in first complete remission are routinely treated using a full intensity     (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient     with AML, full intensity therapy transplants have been greatly limited by increased rates of     toxic effects related to this type of conditioning regimen. Reduced intensity     (non-myeloablative) conditioning regimens have been used in a number of clinical settings,     including AML therapy, to lessen the regimen related toxicity in the older patient. Recent     data from the University of Michigan Blood and Marrow Transplant Program suggests improved     survival for individuals > 55 years in age undergoing reduced intensity, transplants from     unrelated donors. This study will investigate the safety and efficacy of this treatment     option for older patients with AML, with the primary goal being to improve the survival and     lifespan for older patients with AML.   "
211890|NCT00623948|"     This project will evaluate the feasibility of using a fully implanted gluteal stimulation     system for the prevention of Pressure ulcers. The specific goal of this study will be a pilot     clinical trial of veterans with reduced mobility in order to establish clinical efficacy of a     2-channel bilateral gluteal stimulation system. A two-arm crossover study of wheelchair users     with complete SCI will be carried out. All study participants will receive a fully implanted     system incorporating implanted IM electrodes and a Micropulse I IPG stimulator (NDI Medical).     Group assignments will be determined at enrollment using a modified randomization scheme. A     total of 10 subjects will be recruited to the pilot clinical trial.   "
211891|NCT00623961|"     This study seeks to validate clinically evoked or obtained objective pain signs with the     patient's corresponding quantified subjective pain symptoms. This will allow for validation     of objective clinical pain signs to then be used to begin to classify patients with pain     based on symptoms and signs. This then can be used as a basis for further study of     neuropathic pain mechanisms in human patients.   "
211892|NCT00623974|"     Primary Objective:      -To identify the optimal dose of a seven-day course of twice-daily teriparatide as compared     to standard therapy for hypocalcemia in patients after total thyroidectomy and/or extensive     neck dissections (pharyngectomy, laryngectomy,unilateral, bilateral / central neck,     mediastinal lymph node neck dissections), with which serum calcium will be raised to     corrected serum calcium levels of 8-10.5mg/dL and maintained within this range until the end     of the treatment course.   "
211893|NCT00623987|"     Background. The optimal duration of oral anticoagulant treatment in patients with idiopathic     Deep Vein Thrombosis (DVT)of the lower limbs is still uncertain. Residual Vein Thrombosis     (RVT) has been found able to establish the patient' risk for recurrent thrombotic events. In     the present study we conducted a RVT-based therapeutic strategy, withholding OAT after 3     months in patients without RVT while continuing anticoagulants for at least additional 9     months in those in whom RVT persists.      Methods Patients with a first episode of symptomatic unprovoked proximal Vein Thrombosis (VT)     were given Oral Anticoagulant Treatment (OAT) for 3 months. Residual Vein Thrombosis (RVT),     ultrasonographically-detected, will be then assessed. Patients without RVT did not continue     OAT (Group B), whereas those with RVT will continue OAT for at least additional 9 months.     Patients were followed-up prospectively focusing on the study outcomes: occurrence of     recurrent venous thromboembolism and major bleeding over a period of at least 12 months after     OAT discontinuation.   "
211894|NCT00624000|"     Stroke is the third leading cause of death in the United States, responsible for 158,488     deaths in 1998 (American Heart Association). Nationwide, each year, an estimated 600,000 to     750,000 people suffer a new or recurrent stroke. Cerebral infarction comprises 80% of all     strokes and is the result of a complex series of cellular metabolic events that occur rapidly     after interruption of blood flow to a region of the brain. The extent of the brain damage is     dependent on the duration and severity of the cerebral ischemia. Acute thrombus formation or     migration is the principal cause of blood flow interruption in at least 75% of cerebral     infarctions. In several animal models of focal cerebral ischemia, restoration of cerebral     blood flow within two to six hours after initial occlusion has been associated with smaller     volumes of cerebral infarction and improved functional outcome. An effective way of     dissolving the thrombus is by administration of recombinant tissue plasminogen activator or     Activase (Alteplase, rt-PA), which promotes the proteolytic action of plasmin from     plasminogen at the site of a clot. In this study, the drug, Activase, will be administered in     subjects with acute ischemic stroke (AIS) intravenously (IV) or by local intra-arterial (IA)     injection. The use of the intravenous administration within 3 hours of stroke symptom onset     is FDA approved whereas the intra-arterial administration, despite evidence of potential     benefit, is not currently FDA approved. Although not FDA approved, this study will evaluate     the effectiveness of IA thrombolysis with Activase, used in AIS because of its higher rate of     recanalization , potential expansion of the time window out to 6 hours, and lower doses of     thrombolytic agent used compared with systemic or intravenous Activase. The study is designed     to test the feasibility and provide preliminary safety data regarding the relative benefits     and risks of IA Activase as compared to IV Activase when administered per the NINDS rt-PA     stroke study protocol, i.e. randomized within 3 hours of onset of symptoms of ischemic stroke     then treated within 3 hours in the IV Activase arm and within 4 hours in the IA Activase arm.   "
211895|NCT00624013|"     This proposed study will test the following hypothesis: Treating depression in Hispanics and     African Americans with diabetes will improve their HbA1c and quality of life while on     intervention and six months after intervention.      The medication to be used will be sertraline (Zoloft). Sertraline (Zoloft)has been proven in     clinical trials to be an effective and well tolerated prescription medication that improves     the quality and enjoyment of life for adults suffering from depression . Sertraline is an     antidepressant and a member of the family of medications known as selective serotonin     reuptake inhibitors (SSRIs). It has excellent tolerability and minimal drug-drug     intereactions.      The hypothesis will be tested by the following specific aims:        1. To determine if treating mild to moderate depression with sertraline (Zoloft) in          patients with diabetes improves HbA1c.        2. To determine if treating mild to moderate depression with sertraline (Zoloft) in          patients with diabetes improves quality of life.      If our hypothesis proves correct and this treatment of depression is efficient and easy in a     county hospital population of African Americans and Hispanics, researchers can move forward     in finding fast and efficient means of diagnosing depression in vulnerable populations,     including low-literate patients. This study is critical in that it stands to improve the     HBA1c (and other metabolic parameters) and quality of life of our underserved minority     community, which sadly suffers from a higher rate of almost every disease, including     diabetes. Treating mild to moderate depression in a county hospital population of African     Americans and Hispanics may improve quality of life and reduce/prevent complications and     early death. Secondary outcomes include reduced hospitalizations, fewer missed appointments,     and improved adherence to medication.   "
211896|NCT00624026|"     The study objective is to evaluate the effects of memantine treatment on communication     abilities and other cognitive abilities in moderate to severe DAT patients.   "
211897|NCT00624039|"     The purpose of this study is to investigate the changes in the pilocarpine-induced ciliary     body movement before and after cataract extraction in order to determine the effect of lens     sclerosis on the ciliary muscle contractility.   "
211925|NCT00624403|"     The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal     vent. The aim of this study is to compare this device to the LMA ProSeal. The study is     approved by the institutional ethic committee. 222 patients will be enrolled in each group.     The objectives of the study will be to compare insertion success rate, leak pressure,     ventilatory parameters and adverse event rate.   "
211898|NCT00624052|"     The primary objective of this trial is to assess the efficacy and safety of the fixed dose     combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg     (T80/A10) during open-label treatment for at least six months.      An additional objective is to assess the efficacy and safety of concomitant administration of     either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of     hypertension.      The primary endpoint is the proportion of patients achieving DBP control (defined as mean     seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study     treatment) at six months of treatment or at last trough observation during the treatment     period (i.e. last trough observation carried forward).   "
211899|NCT00624065|"     Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2     essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline.     Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril +     placebo. Subjects will be uptitrated over a 6 week period until target blood pressure     (<140/90mmHg) is met. The primary objective of the study is to compare the proportion of     subjects who achieve target blood pressure after 6 weeks of treatment.   "
211900|NCT00624078|"     This treatment protocol will enable therapeutic use of Anascorp in the management of systemic     manifestations of scorpion sting envenomation, in patients for whom antivenom would otherwise     be unavailable. The working hypotheses are as follows:        1. The investigational antivenom is safe as treatment of scorpion sting envenomation.        2. The investigational antivenom is effective as treatment of scorpion sting envenomation.   "
211901|NCT00624091|"     Background: Prognosis of infective endocarditis is poor and has remained steady over the last     four decades. Several nonrandomized studies suggest that early surgery could improve     prognosis.      Methods: The early surgery in infective endocarditis study (ENDOVAL 1) is a multicenter,     prospective, randomized study designed to compare the state-of-the-art therapeutic strategy     (that advised by the international societies in their guidelines) with the early surgery     strategy in high-risk patients with infective endocarditis. Patients with infective     endocarditis without indication for surgery will be included if they meet at least one of the     following: 1) early-onset prosthetic endocarditis; 2) Staphylococcus aureus endocarditis; 3)     periannular complications; 4) new-onset conduction abnormalities; 5) vegetations longer than     10 mm in diameter; 6) new-onset severe valvular disfunction. A total of 216 patients will be     randomized to either of the two strategies. Stratification will be done within 3 days of     admission. In the early surgery arm, the procedure will be performed within 48 hours of     randomization. The only event to be considered will be death within 30 days. The study will     be extended to 1 year. In the follow-up substudy, death and a new episode of endocarditis     will be regarded as events.      Conclusion: The early surgery in infective endocarditis study (ENDOVAL 1), the first     randomized in endocarditis, will provide crucial information regarding the putative benefit     of early surgery over the state-of-the-art therapeutic approach in high-risk patients with     infective endocarditis.   "
211902|NCT00624104|"     The purpose of the study is to investigate and compare the lipid metabolism in lean and obese     individuals. We want to investigate the effect of postprandial hyperinsulinaemia on     VLDL-triglyceride metabolism   "
211903|NCT00624117|"     The purpose of this study is to evaluate the effectiveness of progressive strength training     after rotator cuff and labrum operation of the shoulder joint.   "
211906|NCT00624156|"     We are doing this study to see if writing about life experiences helps women adjust to breast     cancer that has spread. We will compare two groups. One group will write about their breast     cancer experience. The other will write about their daily activities. What we learn from this     study may help us to find new ways to help women cope with breast cancer that has spread.   "
211907|NCT00624169|"     The objective of this study is to implement an optimized perioperative course for patients     surgically treated for peptic ulcer perforation in order to improve the outcome for these     patients.      The optimized perioperative course consists of a number of interventions carried out before,     during and after surgery.   "
211908|NCT00624182|"     The purpose of this study is to evaluate the safety, tolerability, and immune response of     different doses of URLC10 peptide emulsified with Montanide ISA51 in combination with     gemcitabine. Recommended phase II dose will be also determined.   "
211909|NCT00624195|"     CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS     (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI).      The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as     compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different     domains of functioning known to be affected by HIV.      It is hypothesized that participants in the CNS-T arm will have greater improvement in     neurocognitive functioning than those in the non-CNS-T arm.      The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T     HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL).      It is also hypothesized that although CSF viral suppression will be more frequent in the     CNS-T arm, plasma viral suppression will be similar in the two treatment arms.   "
211910|NCT00624208|"     We are investigating a new technique for testing the effect of drugs on electrical activity     in the heart. Disturbances of this electrical activity can cause life-threatening changes to     heart rhythms. A better way of measuring the risk has recently been developed, and our     research team leads the world in using this tool to test the safety of drugs used in     children. Children and their families want to know that the drugs being used are safe, as do     the doctors that care for them. In this study, we will take heartbeat tracings (ECGs) from 60     children before and during their operations. The ECGs will then be checked by a children's     heart specialist. Differences on the ECGs will be related to the presence and amount of drug     (droperidol or ondansetron) given. We expect that the droperidol or ondansetron will not     cause any changes that show increased risk of abnormal heart rhythms. We can then tell     patients, parents and regulatory authorities of the safety profile of this aspect of the     drug; moreover, the study can be used as a model for testing many other drugs used in     hospitals.   "
211911|NCT00624221|"     Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant     technique that replaces only the diseased endothelial cell layer of the patient's cornea. The     DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the     patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time     of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added     service. The purpose of this study was to compare outcomes with eye bank pre-cut and     surgeon-dissected donor grafts for DSEK.   "
211912|NCT00624234|"     The goal of this trial is to determine if children with neurofibromatosis type 1 who have     reading disabilities respond the same way—both behaviorally and neurobiologically—to     specialized treatment programs as children with idiopathic reading disabilities do, and to     determine which intervention is best for particular learner profiles.   "
211913|NCT00624247|"     The objective of this non-randomized, controlled, trial is to evaluate the optimal time to     approach newly incarcerated jail inmates for routine opt-out HIV testing in a manner that     maximizes the number of individuals able to demonstrate capacity to consent and willingness     to receive HIV testing.   "
211914|NCT00624260|"     The risk of recurrence in stage III and IV of colorectal cancers (CRC) is high during the     three years following the tumoral resection with curative aim. Therefore, a prolonged     follow-up and an intense monitoring are recommended to detect these recurrences precociously.     Nevertheless, current consensual morphological and biological examinations are not very     contributory, of difficult interpretation and expensive. The metabolic imagery in     tomoscintigraphy by emission of positron coupled with the scanner, called PET-TDM, allows to     identify more specifically recurrences, analyzes the whole body, detects hepatic metastasis     more precociously and give some benefice for early diagnosis of lymph nodes recurrence. The     principle purpose of this study is to evaluate if the systematic follow-up per PET-TDM allows     detecting more often recurrences accessible to a curative surgery. We make the hypothesis     that the systematic practice of PET- tomodensitometry (TDM) during the follow-up of CRC     allows to decrease non curative recurrences appearance during the 3 years follow-up after a     curative surgery.   "
211915|NCT00624273|"     This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in     systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers     and their count and analyze the effect of sildenafil on angiography.   "
211916|NCT00624286|"     This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily     (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).   "
211917|NCT00624299|"     The surgery to correct leg & foot deformities in children is a lengthy, & sometimes,     difficult procedure. Metal frames are attached to the leg and / or foot and over a period of     time the frame is manipulated to obtain the corrected position. During this period the     muscles & skin become very tight which causes pain & may pull the joint out of position. When     this happens it is sometimes necessary to stop the treatment before the best position is     obtained. This means that not only is the child left with an inadequate result but that     further surgery is required in the future.      If the tension could be removed whilst the treatment is underway this would reduce the pain,     the possibility of joint damage & potentially allow a more satisfactory to be obtained     without the need for further surgery.      Botulinum toxin or Botox, as it is commonly called, has the potential to temporarily reduce     the tension in the muscles without causing permanent damage.   "
211918|NCT00624312|"     The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit     prior to a major surgical oncology operation.   "
211919|NCT00624325|"     For chronic hepatitis C patients unresponsive to previous (PEG-)IFN/RBV combination therapy     we propose continuous subcutaneous administration of high-dose IFN-a2b (Intron A®) for 48     weeks in combination with 15 mg/kg/day RBV (Rebetol®) and optimal management of side effects     in order to maintain the highest possible dosages of both IFN-a2b and RBV for 48 weeks. We     expect improved tolerability with continuous subcutaneous pump delivery of IFN-a2b compared     to thrice weekly or daily subcutaneous injection of IFN-a2b, and increased antiviral activity     and biologic potency due to sustained and higher levels of a fully potent interferon protein.   "
211920|NCT00624338|"     This study is to evaluate the efficacy and safety of atacicept compared to placebo in     preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the     optimal dose of atacicept for treatment of subjects with SLE and gain information on the     effect of atacicept on markers specific to its mechanism of action (MoA) and their     correlation to disease activity/progression. Study medication will be administered through     subcutaneous (under the skin) injections, beginning with twice weekly injections for the     first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a     safety follow-up period of 24 weeks will be conducted.   "
211921|NCT00624351|"     The primary objective of the study is to assess the dose response and the dose frequency of     epratuzumab in patients with SLE.   "
211922|NCT00624364|"     This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and     safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood     glucose control in type 2 diabetes.   "
211923|NCT00624377|"     The purpose of this study is to monitor the change in the health status of severe COPD     patients after the initiation of Tiotropium therapy. This will be assessed by the physician`s     global evaluation of the patient`s health status on a 8-point scale. This measure has been     shown to correlate with a established standard measure of the patients health related quality     of life. The primary analysis in this trial will only include patients not pre-treated with a     long-acting beta-agonist to establish a clear efficacy signal in this patient population. As     the reality of COPD treatment nowadays is poly-pharmacy, a secondary analysis will analyse     patients who are pretreated with long-acting bronchodilators to put the changes in the health     status in a likely real world context. In parallel to these evaluations of the health status,     the lung function response of the patients will be assessed to gain an established objective     measure of treatment response.   "
211924|NCT00624390|"     The purpose of this research study is to obtain preliminary data of the safety and     effectiveness of Sepraspray in a limited number of patients who are under going a     laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity     following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion     prevention barrier after laparoscopic myomectomy versus no adhesion barrier.   "
211927|NCT00624429|"     The Early Head Start program serves lower socioeconomic inner-city children from birth to 3     years. This population has a higher incidence of asthma due to increased exposures. The     primary objective of this study is:      To evaluate the effect of early identification of these high risk, inner-city asthmatic     infants, age 1-3 years, and early treatment with pulmicort respules on asthma morbidity     (asthma symptoms and use of rescue medications), infant pulmonary functions, and use of     health care resources (unscheduled clinic visits, emergency room visits and     hospitalizations).      To obtain pilot behavior information using Carey Temperament Scale, Bitsea and expand to     Itsea if indicated.   "
211928|NCT00624442|"     This study will assess the safety, tolerability, and pharmacodynamics of CK-1827452 infusion     in patients with stable heart failure.   "
211929|NCT00624455|"     Gabapentin is a medicine that has been used in adults (but not yet in children) to treat pain     after surgery. In children it has been used for many years to treat other conditions and has     been shown to be very safe.      Removal of tonsils is a common operation with each child experiencing a similar pattern of     pain; this makes it good for looking at the effect of pain relieving medicines. In our study     each child will get the same operation and medicines, as they would have normally. Before the     operation and in a random way, half will get gabapentin and half will get the same syrup but     with no gabapentin. Afterwards we will record how much pain the children have and how much of     our standard medicine is needed to make them comfortable. We expect both of these results to     be lower in the half who received gabapentin. We will also record the amount and type of     unwanted effects, both from the gabapentin and from any other pain relief medicines.   "
211930|NCT00624468|"     This study was intended to evaluate the efficacy, safety and tolerability of atacicept     compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT     in subjects with ON as CIS. The study was randomized. Study medication was administered via     subcutaneous (under the skin) injections.   "
211931|NCT00624481|"     This study is being conducted to compare the effect of increasing nasal teriparatide dosing     on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy     in postmenopausal women with low bone mineral density.   "
211932|NCT00624494|"     The aim of the present study was to evaluate the usefulness of an algorithm based on     hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with     continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative     management of patients undergoing OPCAB.   "
211933|NCT00624520|"     The purpose of this study is to assess the effectiveness of a 10 week program of Stress     Management versus control Patient Education sessions on cardiac responses to mental stress in     veterans with Implantable Cardioverter-Defibrillators   "
211934|NCT00624533|"     The purpose of this randomized controlled trial was to assess the effectiveness of GDS     Treatment Method for patients with subacute or chronic non-specific low back pain in Primary     Care of Spanish National Health Service.   "
211949|NCT00624728|"     18F-Fluorothymidine is a recently developed PET tracer to image tumor cell proliferation.     Very few data report an interest of using such a tracer for cerebral malignant tumor     management. In our project, we want to compare the tumoral volumes obtained with PET and MRI,     with the gold standard histopathological diagnosis according to the WHO grading malignancy     scale and the Ki-67 proliferation index, for preoperative evaluation as much as for tumoral     postoperative residue evaluation. Furthermore, we want to explore the interest of 18F-FLT-PET     volume to better delineate tumoral volume in radiotherapeutic management of gliomas.   "
211935|NCT00624546|"     Although the symptomatic and epithelial (histologic and endoscopic) response to antireflux     therapy are well known and extensively studied, little is known of the genetic events     occurring in response to proton pump inhibitor therapy. Preliminary data from our laboratory     has shown, for example, that COX-2 expression is not only elevated in patients with     gastroesophageal reflux disease but also can be correlated with pathologic esophageal acid     exposure on 24 hour pH monitoring. Similar studies have suggested that antireflux surgery may     normalize COX-2 gene expression. In contrast studies following ablation of dysplastic     Barrett's epithelium have shown persistence of genetic changes associated with altered     cellular function, despite the return of the histologic appearance to normal. Several key     mediators of inflammation, metaplasia (Barrett's) and neoplasia have now been well     characterized and shown to be important factors in the pathogenesis of esophageal injury. It     is likely that successful antireflux therapy returns altered expression of these mediators     toward normal although this hypothesis remains largely unexplored. The aim of this study is     to investigate gene expression of key mediators of the spectrum of esophageal mucosal injury     and the response to antireflux therapy.      Hypothesis: Antireflux therapy (proton pump inhibitor and surgical fundoplication) normalizes     the expression of genes known to be involved in the pathogenesis of inflammation     (esophagitis), metaplasia (Barrett esophagus) and neoplasia (adenocarcinoma).   "
211936|NCT00624559|"     The purpose of this study is to determine if the drug Celebrex changes the way the kidney     gets rid of salt and maintains blood pressure.   "
211937|NCT00624572|"     The purpose of this study is to evaluate the action of the chlorexidine as intracanal     medicament in the reduction of the levels of bacteria inside root canals of primary molar     teeth with pulpal necrosis.   "
211938|NCT00624585|"     The main purpose of this study is to learn how patients with myelodysplastic syndrome (MDS)     respond to the study drug dasatinib. The study drug, dasatinib, has been approved by the U.S.     Food and Drug Administration (FDA) for treatment of leukemia, but has not been approved for     the treatment of other kinds of cancer. The use of dasatinib in this study is considered     experimental.   "
211939|NCT00624598|"     The purpose of this study is to evaluate the short-term effect of a technology based weight     reduction program for obese (BMI > 30 kg/m2) adults in a primary care office.   "
211940|NCT00624611|"     When a child undergoes heart surgery, a heart lung machine is used to keep blood flowing     while the child's own heart is stopped. After surgery, a significant amount of the child's     own blood is left in this machine. In the case of small children, the relative amount of     blood potentially lost to the child in this way is very large.      In older children, and those who have undergone less complicated surgery, this blood can all     returned to the child. Giving the child back his or her own blood makes is less likely that     the child will need a transfusion of donated blood.      However, in younger children, or in children who have undergone more complicated surgery,     most or all of this blood is thrown away. This is because of worry that returning this blood     may cause bleeding, and excessive bleeding is one of the most feared complications of heart     surgery.      This project will explore a method whereby the red blood cells left in the heart lung machine     can be returned to children without increasing the risk of bleeding. It will also carefully     examine the exact causes of higher bleeding risk in children getting their own blood back so     that in the future, all children can have their own blood returned at the end of surgery.   "
211944|NCT00624663|"     Rivastigmine is a carbamate, approved by the FDA for the treatment of mild to moderate     dementia associated with Alzheimer's and Parkinson's diseases. Studies conducted in the     Israel Institute of Biological Research (IIBR) have yielded encouraging results in utilizing     rivastigmine pre-treatment as an alternative to pyridostigmine in partially protecting     against organophosphate poisoning, particularly protecting the central nervous system.      The target population for this indication may consist of otherwise healthy people (e.g.     soldiers). Although the treatment regimen has not been established yet it is assumed, based     on animal experiments, that rivastigmine is likely to be administered in repeated doses. In     this setting, further evaluation of the drug's effects and pharmacokinetics in young healthy     subjects is warranted.      The objectives of this study are: 1) To assess the safety and tolerability of repeated     rivastigmine administration (1.5 mg and 3 mg) in young healthy male volunteers; 2) To     determine the pharmacokinetic profile of rivastigmine (1.5 mg and 3 mg) following a single     and multiple dose administrations; 3) To assess the extent of blood ChE inhibition following     a single and multiple administrations of rivastigmine and 4) To correlate physiological and     behavioral effects with blood rivastigmine concentrations and blood ChE inhibition in these     subjects.      This double-blind, placebo-controlled study will be divided in 3 identical periods, preceded     with a two-day initial training in performing cognitive performance tests. Each period will     consist of in-house confinement for 5 days in which rivastigmine will be administered 5 times     at an interval of 12 hours. During each period, each subject will receive either rivastigmine     1.5 mg X 5, or either rivastigmine 3.0 mg X 5 or placebo X 5. The treatment in each period     will be randomly assigned in a crossover manner. Rivastigmine pharmacokinetics will and     acetylcholinesterase inhibition will be assessed after the first and the last dose of each     period and will be correlated with physiological and cognitive parameters: performance tests,     visual functions, peak airway flow, saliva production (sialometry) and vital signs.      The emergence of adverse events will be monitored throughout the study   "
211945|NCT00624676|"     Acne vulgaris is a frequent inflammatory skin condition involving the pilosebaceous unit and     affecting more than 80% of teenagers. Mild to moderate acne vulgaris is usually treated with     topical agents such as benzoyl peroxide, retinoids and antibiotics. These treatments can be     associated with local tolerance problems and/or antibiotic resistance. Salicylic acid has     been shown to be an effective treatment for acne. LHA is a lipophilic hydroxy acid derivative     of salicylic acid that has comedolytic and antibacterial properties.      The objective of this trial was to compare the efficacy and tolerance of a cream formulation     containing 0.3% LHA (LHA formulation) to a 5% benzoyl peroxide gel.   "
211946|NCT00624689|"     Formula-fed infants differ from breast-fed infants in the growth pattern, risk for obesity     and cardiovascular diseases, neurological development and morbidity in infections.      The investigators' hypothesis is that a modified formula with reduced energy and protein     content and enrichment with Milk Fat Globule Membrane (MFGM) containing bioactive proteins     and phospholipids will reduce the difference between formula-fed and breast-fed infants.   "
211947|NCT00624702|"     This study will explore information on whether changing the salt formulation of indacaterol     affects the incidence of post-inhalation cough.   "
211948|NCT00624715|"     This study attempts to characterize the effects of tetrahydrocannabinol (THC).     Tetrahydrocannabinol is the active ingredient of marijuana, cannabis, ganja, or pot. This     study will involve healthy volunteers who 1) have no history of alcoholism in their family or     2) have a family history of alcoholism. This study looks at individuals with or without a     family history of alcoholism to determine if there is a difference between the two groups in     the response to THC.   "
211951|NCT00624754|"     The usual treatment for obstructive airway disease (OAD) after allogeneic hematopoietic stem     cell transplantation (AHSCT) , which is related to graft versus host disease (GVHD), consists     of intensification of systemic immunosuppressive therapy.   "
211952|NCT00624767|"     Insulin is a hormone which is produced by the human pancreas for the lowering of blood sugar.     In patients who don't produce enough insulin, additional insulin must be given several times     per day by injections. Nastech Pharmaceutical Company Inc. has developed a new insulin nasal     spray, as a possible way to improve patient compliance with intensive insulin treatment     plans. This study is being conducted to see how Nastech's insulin nasal spray affects     post-meal glucose levels compared with rapid acting insulin (i.e., insulin aspart) in Type 2     diabetics who are already taking oral antidiabetic medications and/or insulin therapy.     Insulin aspart is marketed as NovoLog® in the United States. The safety of insulin nasal     spray and how well it is tolerated as compared to NovoLog will also be evaluated.   "
211953|NCT00624780|"     The purpose of this study is to characterize the safety and efficacy in patients with     generalized anxiety disorder after short- (3 months) and long-term (6 months) use of     Pregabalin (Lyrica).   "
211954|NCT00624793|"     The subjects in this research study will be 159 men and women with HIV infection who have a     history of chronic nausea for three months or greater and show evidence of two or more     episodes of nausea and/or report a duration of two hours or more (per day) in baseline     symptom diaries. Subjects will be randomized (by chance) to one of three conditions:     Condition 1, subjects receive Standard acupuncture (active treatment); Condition 2, subjects     receive Individualized acupuncture based on Traditional Chinese Medical Diagnosis (active     treatment); Condition 3, (Control Group), subjects receive Sham acupuncture. Subjects in     Conditions 1, 2, & 3 will attend scheduled sessions over 24 weeks.   "
211955|NCT00624806|"     The Veteran's Health Administration (VHA) is a national leader in using distance technology     to monitor patients' self-care via an in-home messaging device with disease management     protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders     (SCI/D) population. Our objective is to develop the tools necessary for implementing a new     home telehealth program to manage community-dwelling veterans with SCI/D at high risk of     developing pressure ulcers (PrUs).   "
211980|NCT00625157|"     Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical     forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease     confined to the skin.      The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream     0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.   "
211956|NCT00624819|"     This protocol posting deals with objectives & outcome measures of the extension phase up to     48-50 months post booster vaccination, to assess long-term antibody persistence in children     at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal     conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a     separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in     order to comply with the FDA AA (Sep 2007).   "
211957|NCT00624832|"     This study was intended to demonstrate that patients with standard and high immunoglobulin E     (IgE) levels can be protected from allergen induced broncho-constriction by Xolair   "
211958|NCT00624845|"     The purpose of this study is to assess the benefit of OMS103HP for Injection (OMS103HP)     compared with vehicle irrigation solution for prevention of pain and pain relief in subjects     undergoing meniscectomy. The pain relief is assessed based on Visual Analog Scale (VAS) Pain     Scores in the immediate 24-hour postoperative period and for seven days postoperatively.   "
211959|NCT00624858|"     The purpose of this study is to determine whether a combination of naltrexone SR and     bupropion SR is safe and effective in the treatment of major depression in overweight or     obese subjects.   "
211960|NCT00624871|"     Oxygen radicals and inflammation are important causes for brain injury in neonates following     perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using     both of vitamin C and ibuprofen. The efficacy of these 2 drugs when combined in protecting     the human brain has not been studied. We aimed in this study to test the hypothesis that a     combination of anti-oxidants (vitamin C) and anti-inflammatory (ibuprofen) drugs can decrease     the brain injury in perinatal asphyxia and improve outcomes when given to infants immediately     after birth.   "
211961|NCT00624884|"     Velocity Vector Imaging may provide reliable and detailed information on left ventricular     segmental function in asymptomatic patients with moderate-to severe AR. This may help to     identify subclinical myocardial dysfunction in order to operate early enough to prevent     postoperative heart failure and restrict unnecessary early operation which could be     associated with operative risks and mortality related to prosthetic valves.   "
211962|NCT00624910|"     The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and     effective in reducing the amount of narcotic pain medication needed to control pain during     the first 24 hours after abdominal hysterectomy surgery.   "
211963|NCT00624923|"     The hypothesis is that western lifestyle, with sedentary behaviors and caloric excess promote     a chronic, subacute inflammatory state that participates in the development and progression     of atherosclerosis. We will evaluate the effects of targeting inflammation using the     anti-inflammatory drug salsalate, compared to placebo, on coronary artery plaque volume     assessed by multi-detector computed tomographic angiography (MDCTA). The TINSAL-CVD study is     a randomized, double-masked, placebo-controlled, 2 arm, clinical trial.      The purpose of the study is to compare the effect of salsalate or placebo on sub-acute     inflammation and coronary plaque, in people with cardiovascular disease. Participants are     randomized to active intervention (salsalate) or placebo interventions for a period of 30     months. The primary endpoint is change in plaque volume in the coronary arteries assessed by     MDCTA from baseline to 30 months.   "
212002|NCT00625456|"     This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic     solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small     cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck.     These tumor types were selected because evidence of biological activity was observed in these     tumor types in a Phase I study of JX-594 (Pexa-Vec) administered by intratumoral injection in     patients with metastatic disease to the liver. Patients will receive treatment at one of five     dose levels in a sequential dose-escalating design.   "
211964|NCT00624936|"     RATIONALE: Drugs used in chemotherapy, such as azacytidine work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.     Bortezomib may stop the growth of cancer cells by blocking blood flow to the cancer and by     blocking some of the enzymes needed for cell growth. Giving azacytidine together with     bortezomib may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     giving together with azacytidine in treating patients with relapsed or refractory acute     myeloid leukemia or myelodysplastic syndromes.   "
211965|NCT00624949|"     An observational study of 102 women with Turner syndrome followed for 6 years with a     two-yearly examination including ECHO, MRI of the heart and 24 ambulatory blood pressure. It     has been found that besides an significantly increased risk of congenital cardiac     malformations, TS have an increased risk of developing cardiac disease including the life     threatening condition of aortic dilatation and rupture. The aim of the study is to describe     the cardiac conditions of TS, evaluate different methods of examination and identify possible     risc factors.   "
211966|NCT00624962|"     RATIONALE: Tubefeeding may help maintain good nutrition and lessen weight loss in younger     patients receiving chemotherapy for cancer.      PURPOSE: This clinical trial is studying how well tube feedings work in younger patients     receiving chemotherapy for newly diagnosed acute myeloid leukemia, myelodysplastic syndrome,     or high-risk solid tumors.   "
211967|NCT00624975|"     The purpose of this study is to confirm the safety and immunogenicity of Peru-15 vaccine in     infants when given simultaneously with measles vaccine.   "
211968|NCT00624988|"     The purpose of this investigation is to determine the effect of lower limb vibration therapy     on bone density in the tibia in patients with spinal cord injury. The second purpose is to     assess the neuromuscular junction variability at the motor units of the tibialis anterior     muscle after a sequence of lower limb vibration therapy   "
211969|NCT00625001|"     Turner Syndrome (TS) is associated with osteopenia and osteoporosis. Reduced bone mineral     density (BMD) and increased risk of fractures are present in many younger and middle-aged     women with TS. The objective is therefore to describe longitudinal changes in BMD in TS.      The study is an observational follow-up study. Examinations at baseline, after 5 and 10     years.      Bone mineral density is measured by dual energy x-ray absorptiometry (DEXA) and bone turnover     by bone markers.      Main Outcome Measures: Bone mineral density (BMD; grams/ square centimetre) were measured at     lumbar spine, hip and the non-dominant forearm.   "
211970|NCT00625014|"     We hypothesized that short-term treatment with haloperidol induces insulin resistance through     a mechanistic route that is independent of weight gain. We therefore treated healthy     non-obese men with haloperidol for 8 days, and studied the impact of these intervention on     glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution     technology and indirect calorimetry.   "
211971|NCT00625027|"     The purpose of this study is to compare the rate of non-urgent emergency department use     between three groups of patients: those who were referred to the emergency department by     Telehealth Ontario; those who were referred by a physician; and those who arrived without     being advised by a nurse or a doctor.   "
211972|NCT00625040|"     To evaluate the impact of laparoscopic adjustable gastric banding (LAGB) on beta-cell     function, insulin sensitivity, incretin function, postprandial secretion of incretin hormones     (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) in     morbidly obese patients and to describe the pathophysiological mechanisms involved in the     amelioration of glucose homeostasis during long-term weight loss.   "
211973|NCT00625053|"     Background: Midline incisional hernia is reported from 0,5 to 11% after abdominal operations.     Primary repair without mesh reinforcement is almost abandoned because of high recurrence     rates (24 to 46%). Use of prosthetic mesh in incisional hernia repair lowered the recurrence     rates under 10%. Recurrence rate alone is not the main quality criterion for incisional     hernia repair anymore. Large series and meta-analyses confirmed the value of laparoscopic     repair as at least equal if not better compared with open repair. Discomfort, pain,     diminished quality of life and body image alteration influences functional well being. No     baseline information exists in any of these fields treating pre- or post-operative phases in     patients with incisional hernia. Respiratory functions and medico-economic evaluation are     other rarely investigated fields that we consider in our trial. The objective of this study     is to analyse the functional outcome status of patients after laparoscopic incisional hernia     repair compared to open repair.      Methods: A randomized controlled non-blinded clinical trial is designed to compare     laparoscopic incisional hernia mesh repair with open repair on post operative pain, health     related quality of life outcomes, body image and cosmetic measurements, respiratory     functions, recurrence rates, and cost. Volunteers will be recruited in Geneva University     Hospital, department of surgery, visceral surgery unit. Eligibility criteria is male patient     aged over 18 years, with reducible incisional hernia who are candidates for elective surgery     and medically fit for general anesthesia.30 patients will be enrolled for each group.     Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post operative months by     questionnaires and by clinical exam by independent expert. An overall cost-analysis will be     realized. Patient enrollment in the study will start in April 2008 and estimated to end in     september 2009.   "
211974|NCT00625066|"     RATIONALE: Collecting and storing samples of tissue, blood, and other body fluids to test in     the laboratory and gathering information about health and lifestyle from participants may     help doctors learn more about cancer risk factors.      PURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors     for developing colorectal adenomas or polyps in participants undergoing colonoscopy.   "
211975|NCT00625079|"     Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is     a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently     there is no significant data to support the use of pulmonary vasodilators for PAH in the     setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH     either at rest or during exercise. The study hypothesis is that sildenafil may improve     morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or     exercise PAH.   "
211976|NCT00625092|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to     several degrees above normal body temperature. Peritoneal infusion of heated and nonheated     chemotherapy drugs after surgery may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of hyperthermic     intraperitoneal oxaliplatin followed by intraperitoneal leucovorin and fluorouracil in     treating patients with peritoneal cancer.   "
212407|NCT00632684|"     This study will develop and evaluate the effectiveness of an adaptive treatment model for     reducing the stress of, and burden on, family members caring for a person with dementia.   "
211977|NCT00625105|"     This study will test the effectiveness of Heart Rate Variability (HRV) Biofeedback as a     therapeutic tool in the reduction of everyday memory problems routinely experienced by combat     veterans with Posttraumatic Stress Disorder (PTSD). The study is innovative in three ways:     (1) through its investigation of the clinical use of a novel PTSD treatment technology, (2)     by focusing on the understudied aspect of the daily functioning of PTSD veterans, and, (3) by     investigating a heretofore untested application of biofeedback for PTSD induced deficits in     attention (ATTN) and immediate memory (IM). Though HRV Biofeedback has proven successful for     several applications in the general population, the idea that deficits in ATTN/IM in combat     veterans with PTSD can be remedied by normalization of HRV has not yet been tested     empirically. HRV is functionally incorporated into attentional processes, essentially     operating as an index of autonomic flexibility and the ability to self-regulate in response     to stimulation from the environment. Low HRV occurs in patients with PTSD, General Anxiety     Disorder, and Coronary Artery Disease, and is correlated with negative affect and hostility.     HRV Biofeedback training has been shown to be effective in increasing HRV in these groups of     patients, as well as improving psychological well-being and physiological function in     patients with Depression, Fibromyalgia, and Cardiovascular Disease. Therefore, the     interrelationship between HRV and ATTN/IM problems in PTSD+ Combat veterans warrants further     investigation. If HRV Biofeedback significantly improves ATTN/IM in these subjects, then it     can be offered to VA clinicians treating combat PTSD as an effective new treatment tool.   "
211978|NCT00625118|"     This will be an observational study where parents/ guardians of children in receipt of their     preschool booster will be approached for their child(ren) to take part. Following written     informed consent the Vaccine Research Nurse will explain the purpose of the study and what     would be involved. Participation will involve completion of a health diary for the week     following vaccination to document how their child has been both in terms of local reactions     and systemic symptoms as well as any visits to a doctor (GP or hospital). The nurse will     telephone the family at 48−72 hours following vaccination to see how the child has been.     Information about the vaccine given in the current campaign and vaccines administered in the     infant schedule including date of administration, product and batch number will be recorded     where available.      Should any large local reactions be reported the nurse may visit the child to take a     photograph to document and illustrate these - photographs will be taken without the child's     face visible.      Subjects will be recruited in two centres - Hertfordshire and Gloucestershire. Recruitment     will start as soon as the necessary approvals are in place. Monthly reports of observed data     will be submitted to the MHRA though the formal analysis will not be conducted until the end     of the study.      Recruitment figures and the incidence of ESLs will be reviewed on a six−monthly basis.      At this point it is difficult to predict parental attitude to taking part, though from     experience with recruitment in previous studies it is hoped this will be positive, so     affording a large number of participants.   "
211979|NCT00625131|"     This study seeks to evaluate the relationship between PTSD, abstinence, and factors     associated with relapse in the context of a randomized, clinical smoking cessation trial.   "
211981|NCT00625170|"     We hypothesized that short-term treatment with AP drugs induces insulin resistance through a     mechanistic route that is independent of weight gain and that atypical drugs exert stronger     effects than typical compounds in this respect. We therefore treated healthy non-obese men     with olanzapine (atypical AP) or haloperidol (typical AP) for 8 days, and studied the impact     of these interventions on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp,     isotope dilution technology and indirect calorimetry.   "
211982|NCT00625183|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy     uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together With     selenomethionine and radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well selenomethionine works when given together     with capecitabine, oxaliplatin, and radiation therapy in treating patients undergoing surgery     for newly diagnosed stage II or stage III rectal cancer.   "
211983|NCT00625196|"     A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is     being developed for once daily administration for the maintenance treatment of asthma and     COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and     compared with GW642444M and GW685698X administered separately in order to determine whether     co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics     of either compound in healthy Japanese subjects.   "
211984|NCT00625209|"     This study aims at comparing the efficacy and safety of recombinant human activated protein C     to that of low dose of corticosteroids and at investigating the interaction between these     drugs in the management of septic shock   "
211985|NCT00625222|"     The aim of the study is to establish tDCS as a prognostic tool to predict VNS therapy outcome     among patients with pharmacoresistant epilepsy.   "
211986|NCT00625235|"     An investigation into long term weight maintenance using a high protein or high carbohydrate     diet, after a large and rapid weight loss.   "
211987|NCT00625248|"     This study will evaluate bleeding risk and differences in outcomes in patients receiving and     not receiving anticoagulant or antiplatelet therapy   "
211988|NCT00625261|"     The purpose of the study is to examine the effectiveness of a highly-structured parent-based     language intervention group program for two-year-old children with language delay.   "
211989|NCT00625274|"     This study looks at controlling intragastric pH following administration of esomeprazole 40     mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking     either non-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory     drugs (NSAIDs).   "
211990|NCT00625300|"     The purpose of this study is to test the effects of deep rTMS using the novel H-coil on the     motor, affective and cognitive deficits in patients with Parkinson's disease (PD) and to     establish its safety in this population.   "
211991|NCT00625313|"     The purpose of this study is to assess the safety and efficacy of the HMY Model YA-60BB     Intraocular Lens (IOL) when implanted in the posterior chamber of the human eye for the     optical correction of aphakia following cataract extraction.   "
211992|NCT00625326|"     Low doses of topically administered vitamin D analogs have been shown to have an     anti-psoriatic effect without the risk of hypercalcemia. Calcipotriol, the most thoroughly     studied of the vitamin D analogs, was first approved in Europe in the early 1990s. It has     been shown to be comparable or slightly more effective than class II corticosteroid     ointments. However, patients had reduced levels of parathyroid hormone; mean serum and urine     calcium were increased during treatment and hypercalciuria was observed. These effects were     reversible with discontinuation of therapy. Thus, while calcipotriol ointment was shown to be     effective, the potential for alterations in calcium homeostasis have limited its use to 100 g     of ointment per week (0.5 mg calcipotriol/week). Work has continued on the creation of new     vitamin D analogs, such as COL-121, with the intent of eliminating the adverse effects of     hypercalcemia and hypercalciuria with a compound that is more stable and more easily     administered.   "
211993|NCT00625339|"     This is a randomized, open-labelled, prospective 96-week study comparing the antiviral     efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining     lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.   "
211994|NCT00625352|"     Cares for elderly patients with advanced non-small cell lung cancer(NSCLC) become one of the     common clinical practices oncologist are now facing. So, we need to seek adequate regimens     for them. Gemcitabine is well known to be one of active third generation agents in terms of     both efficacy and tolerability. Gemcitabine alone have been recommended as first line     treatment for elderly NSCLC patients, especially in the aspect of tolerability. However,     gemcitabine alone is suggested to be suboptimal to control their disease. Therefore, we plan     to make an optimal regimen containing gemcitabine for the elderly patients.   "
211995|NCT00625365|"     The purpose of this registry study is to gather safety information on the current clinical     use of and the safety of DEFINITY®   "
211996|NCT00625378|"     This study will enable patients receiving sorafenib (Nexavar) in the completed Bayer/Onyx     sponsored clinical trials to continue treatment. During the entire course of the study,     numerous patients will be treated with sorafenib. Involvement in this study will be depending     on whether the patient benefits from the treatment or not, based on the physician's judgment     and the results of particular additional examinations. Overall, participation in this study     will help to evaluate the safety and efficacy of treatment with sorafenib.   "
212017|NCT00625664|"     This is a randomized, open-label, multi-center study comparing the efficacy and safety of     XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally     advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare     overall survival. Secondary objectives include comparisons of progression free survival,     objective response rate, time to definitive deterioration of performance status, duration of     response, time to definitive weight loss, and assessments of overall safety, and     pharmacokinetics. Patients are treated until disease progression, death, or unacceptable     toxicity and are followed-up until death or the end of the study whichever comes first.   "
211997|NCT00625391|"     Osteoporosis is a major health problem in postmenopausal women. Our long-term goal is to     develop a new alternative treatment that include a dietary supplement (green tea extract) and     a mind-body exercise (Tai Chi) for lessening bone loss in postmenopausal women with low bone     mass. A combination of dietary supplement and moderate intensity exercise now becomes a new     alternative treatment in reducing bone loss in postmenopausal women with low bone mass, due     to the possible stronger effects of the combination than individual treatments. Objective: To     test a CAM intervention including green tea polyphenol (GTP) and Tai Chi (TC) exercise for     feasibility, and to quantitatively assess their individual and conjugate effects on     postmenopausal women with osteopenia. Hypotheses: (1) 24 weeks of GTP supplement, TC     exercise, and their combination will benefit bone remodeling as measured by bone biomarkers     and muscle strength/physical function in postmenopausal women with osteopenia compared to     those receiving placebo only, and (2) the changes in bone biomarkers associated with bone     remodeling will be correlated with the changes in oxidative stress.   "
211998|NCT00625404|"     This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative     women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to     investigate the safety and effectiveness of a once-daily Truvada® pill (compared with     placebo) in preventing HIV among HIV-uninfected women at risk of becoming infected through     sexual intercourse.      The study population included HIV-antibody-negative women between the ages of 18-35 who were     at risk of HIV acquisition through sexual intercourse. Each participant was randomized to     take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of     emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical     placebo.      After enrollment, each participant was followed every four weeks. All participants were     followed for an additional eight weeks after study drug was stopped. Incidence rates of HIV     infection were compared between the two groups (active drug and placebo) using the     intent-to-treat principle.   "
211999|NCT00625417|"     RATIONALE: Diagnostic procedures, such as optical spectroscopy, may help learn the extent of     disease and allow doctors to plan better treatment.      PURPOSE: This phase I trial is studying optical spectroscopy to see how well it works in     evaluating tumor margins in patients who have undergone surgery for breast cancer.   "
212000|NCT00625430|"     The primary objective of this study is to determine the safety and tolerability of a     gene-directed enzyme prodrug therapy for prostate cancer. FP253 contains an ovine     atadenovirus that expresses the E. coli enzyme purine nucleoside phosphorylase (PNP) under     the control of a prostate-directed promoter. PNP converts systemically administered     fludarabine (the prodrug) into 2-fluoroadenine (the active agent) at the site where FP253 has     been administered (the prostate). This localized conversion is expected to provide     organ-targeted chemotherapy that should reduce the systemic side effects associated with     classical chemotherapy and also reduce the risk of debilitating damage to tissues surrounding     the prostate.   "
212001|NCT00625443|"     The purpose of this study is to determine the safety and efficacy of AKR-501 administered in     patients with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and     completed 28 days of study treatment in Protocol 501-CL-003.   "
212238|NCT00631046|"     The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and     body composition, intestinal health and microbiotic composition, immune function and risk     markers for later diseases in 9-18 months old infants and toddlers.   "
212003|NCT00625469|"     Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is     a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently     there is no significant data to support the use of pulmonary vasodilators for PAH in the     setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH     either at rest or during exercise. The study hypothesis is that bosentan may improve     morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or     exercise PAH.   "
212004|NCT00625482|"     Our group has consistently found that the major interventions to reduce morbidity and     mortality in low-income countries have sex-differential effects. These interventions include     BCG vaccine, oral polio vaccination (OPV), and vitamin A supplementation (VAS).      Low-birth-weight (LBW) children constitute the largest high-risk group in low-income     countries. According to current policy, they receive OPV at birth. Current evidence suggests     that a policy of providing BCG with OPV for girls and VAS instead of OPV for boys at birth     may improve survival in LBW neonates. This will be tested in a large randomized trial.      We experienced an unexpected cluster of deaths among boys in the VAS arm, which could be due     to chance, but we decided to stop randomizing boys to OPV or VAS. Very recent evidence has     suggested that low-birth-weight boys may benefit from BCG at birth as well. Hence, we have     obtained ethical permission to continue the trial with randomization of boys to OPV or OPV     plus BCG.   "
212005|NCT00625495|"     The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered     orally compared to intravenously on the maximum acid output in subjects with symptoms of     Gastroesophageal reflux disease (GERD).   "
212006|NCT00625521|"     Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical     forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease     confined to the skin.      The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream     0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.   "
212018|NCT00625677|"     The purpose of this study is:      To assess whether there are differences in antibody persistence eight months post primary     (pre−booster) or in responses to the booster with regard to the Meningococcal C Conjugate     (MCC) vaccine given in infancy.      To examine levels of diphtheria and tetanus antibody pre− and post−booster, with regard to     the carrier proteins contained in the conjugate vaccines.   "
212019|NCT00625690|"     RATIONALE: Screening tests, such as CT scanning, may help doctors find cancer cells early and     plan better treatment for lung cancer.      PURPOSE: This clinical trial is studying how well a lung cancer screening program using CT     scanning works in current and former smokers.   "
212007|NCT00625534|"     Background: Large acceptance of mesh reinforcement techniques in groin hernia repair lowered     recurrence rates for all techniques. Recurrence rate alone is not the main quality criterion     for hernia repair anymore. Chronic significant post operative pain is a common, clinically     relevant, poorly understood and poorly studied entity which is 3 to 5 times more common than     hernia recurrence. As a subgroup to chronic significant post operative pain or as a separate     entity, sexual dysfunction due to ejaculatory and genital pain after inguinal hernia repair     may happen in approximately 2.5% of patients. Patient's preoperative psychological profile as     well as pain exposure history is showed to be important in the development of chronic     significant post operative pain. The objective of this study is to analyse chronic     significant post operative pain and the functional outcome status of patients after     laparoscopic repair compared to open repair.      Methods: A randomized controlled non-blinded clinical trial is designed to compare open     inguinal hernia mesh repair with laparoscopic totally extraperitoneal repair on chronic     significant post operative pain, pain related sexual function disorders, complications,     health related quality of life outcomes, recurrence rates, and cost. Volunteers will be     recruited in Geneva University Hospital, department of surgery, visceral surgery unit.     Eligibility criteria is male patient aged over 21 years, with reducible inguinal unilateral     or bilateral primary hernia who are candidates for elective surgery and medically fit for     general anesthesia.130 patients will be enrolled for each group to achieve an α-Level of 0.05     and a power of 80%. Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post     operative months by questionnaires and by clinical exam by independent expert. An overall     cost-analysis will be realized. Patient enrollment in the study will start in April 2008 and     estimated to end in may 2009.   "
212008|NCT00625547|"     The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with     levodopa in the treatment of patients with RLS.   "
212009|NCT00625560|"     This is a randomized, open-labelled, prospective 96-week study comparing the antiviral     efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining     lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine     monotherapy.   "
212010|NCT00625573|"     This is an open-label, phase II study to evaluate the efficacy and safety of Abraxane in     combination with Capecitabine in patients with metastatic colorectal cancer in the second or     third line   "
212011|NCT00625586|"     RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving RAV12 together with gemcitabine may kill more     tumor cells.      PURPOSE: This phase II trial is studying the side effects and best dose of monoclonal     antibody RAV12 when given together with gemcitabine in treating patients with metastatic     pancreatic cancer.   "
212012|NCT00625599|"     As the population's life expectancy increases, fractures among the elderly in El Salvador are     also increasing. There is currently limited data specific to the incidence and cause of     fractures in the elderly within developing countries, such as El Salvador. The problem of     inadequate knowledge pertaining to bone health and osteoporosis among the elderly is     contributing to this aging population's health issues. The purpose of this study is to     investigate the incidence, prevalence, and risk factors effecting elderly patients admitted     for fractures at the Hospital Zacamil in San Salvador, El Salvador. The study will also     assess the current knowledge in two distinct populations on bone health and osteoporosis. The     first population will be the patients over the age of 45 that present to Hospital Zacamil     with acute fractures and are consulted by the department of orthopedics. The second     population will consist of students at the Evangelical University over the age of 18 in     non-medial track studies. All individuals will have to accept the invitation to participate     in the study. In addition, educational materials will be developed on the prevention of     fractures for medical professionals and for the elderly in El Salvador. The study objectives     will determine incidence and prevalence of elderly fractures of patients over the age of 45     at Hospital Zacamil. Secondly, the study will look at demographic information, prevalent     causes of fractures, treatment of the fractures, morbidity and mortality, and any     complications that may arise in the fracture patients prior to their discharge from the     hospital. Thirdly, the study will seek out the current level of knowledge on bone health,     osteoporosis, and fracture prevention in the young, educated Salvadorians and patients over     the age of 45 at Hospital Zacamil. Fourthly, the study will address the benefits of the     information gained by use of educational materials with the patients and doctors of El     Salvador.      Hypothesis One:      Fractures of the elderly at Hospital Zacamil are significantly associated with occurring at     the hip, wrist, and vertebra in comparison to other fracture locations.   "
212013|NCT00625612|"     The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of     Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or     equal to 75% but less than or equal to 110% predicted.   "
212014|NCT00625625|"     RATIONALE: Diagnostic procedures, such as lymph node mapping during surgery and sentinel     lymph node biopsy, may help doctors find micrometastases and predict cancer recurrence.      PURPOSE: This phase II trial is studying how well lymph node mapping during surgery together     with sentinel lymph node analysis and blood testing work in detecting and predicting early     micrometastases in patients with colorectal cancer.   "
212015|NCT00625638|"     The goal of this research study is to learn if using an Interactive Voice Response (IVR)     system can bring about better and more timely symptom control for patients with advanced     cancer.      Primary Objectives:        -  To determine whether the Interactive Voice Response (IVR) system, supplemented by          Nursing Telephone Intervention (NTI), results in better symptom management and quality          of life than standard care for individuals with advanced cancer as evidenced by reduced          scores on symptom measures.        -  To determine whether the IVR system, supplemented by NTI, results in reduced caregiver          burden, increased caregiver satisfaction with care, and improved coping strategies.        -  To determine the feasibility of using an IVR system, supplemented by NTI, for symptom          assessment in individuals with advanced cancer and their caregivers by conducting a          process evaluation of the system. Variables to be evaluated include rates of participant          recruitment and retention, frequency of use of the system, acceptability of the system          to participants, and barriers to participation. Researchers' goal is to identify and          improve aspects that affect external validity (recruitment rate, cohort maintenance),          internal validity (implementation, contamination), participant acceptability and          satisfaction, and reaction to study procedures. The findings from this evaluation will          also allow researchers to evaluate delivery of interventions in future studies.   "
212016|NCT00625651|"     This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed     to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab     compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic     colorectal cancer (CRC).      The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured     by progression-free survival, objective response rate, time to response, duration of     response, and overall survival. This study is also designed to evaluate the safety and     tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG     655 antibody formation and the pharmacokinetics of AMG 655.   "
212020|NCT00625703|"     To determine the pharmacokinetic profile of IV (intravenous) and PO (oral) formulations of     linezolid among children with cystic fibrosis and establish a dose regimen that will be safe     and effective.   "
212021|NCT00625729|"     RATIONALE: Aldesleukin may stimulate natural killer cells to kill cancer cells. Treating     natural killer cells with aldesleukin in the laboratory may help the natural killer cells     kill more cancer cells when they are put back in the body. Giving monoclonal antibodies, such     as rituximab, and chemotherapy drugs, such as fludarabine and cyclophosphamide, before a     donor natural killer cell infusion helps stop the growth of cancer cells. It also helps stop     the patient's immune system from rejecting the donor's stem cells.      PURPOSE: This phase I/II trial is studying how well giving rituximab and chemotherapy     followed by a donor natural killer cell infusion that has been treated in the laboratory with     aldesleukin followed by aldesleukin works in treating patients with non-Hodgkin lymphoma or     chronic lymphocytic leukemia.   "
212022|NCT00625742|"     The primary aim of this proposal is to present a novel, multimodal treatment strategy for     increasing lean body mass in individuals with cancer who experience cachexia between baseline     and day 29 (+/- 3 days). The strategy includes graded resistance training and aerobic     exercise, targeted nutrient supplementation and pharmacologic intervention (melatonin).      We postulate that this strategy, together with the simultaneous management of symptoms that     decrease appetite (e.g. depression, pain, and nausea), will also accomplish our secondary     objectives of improving clinical outcomes such as strength and function between baseline and     day 29 (+/- 3 days).   "
212023|NCT00625755|"     This study will look how using taken from your tumors and mixed with special immune     stimulating cells from another person's blood in given back to you in a series fusion cell     injections, will effect your body. The primary goal of the study is to see if giving the     experimental fusion cell injections is safe. We will also be looking to see what effect the     experimental treatment as on your immune system and whether it has an effect on your cancer.   "
212024|NCT00625768|"     To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of     AS1409 in single and repeated doses.   "
212025|NCT00625781|"     The purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women     with impaired glucose tolerance (75-g OGTT with a fasting P-gluc <7.0 mmol/l and 2 h P-gluc     >10.0 and <12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal     morbidity. There will be a focus on treatment according to specific goals and separate     follow-up regimes for the children and women post partum.   "
212026|NCT00625794|"     The objective of this pilot study is to determine the feasibility and utility of using the     nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking.   "
212027|NCT00625807|"     Currently there are 2 popular stress reduction courses that are widely used in the US.     Although they use somewhat similar techniques, it is currently unknown whether or not they     work the same way, or if they are similarly effective at reducing stress. The study will     directly compare these 2 courses. Participants will undergo approximately 4-5 hours of     testing before and after each 8-week course.   "
212039|NCT00608023|"     HIV lipodystrophy affects a significant proportion of patients treated with combination     antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss     of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance.     Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated     that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV-     infected patients with excess of abdominal fat accumulation for 26 weeks resulted in     decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and     subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations     made during the first Phase 3 study.   "
212040|NCT00608036|"     Many teenagers have unhealthy eating habits and do not get enough physical activity. This     study will examine whether the neighborhood in which a teenager lives affects his/her quality     of life, physical activity levels, and eating habits.   "
212028|NCT00625820|"     Patients with chronic kidney disease (CKD) and albuminuria are at increased risk of     developing cardiovascular disease (CVD) which is often associated with hypertension, left     ventricular hypertrophy, endothelial dysfunction and increased generation of reactive oxygen     species (ROS). These patients also manifest a decrease in nitric oxide (NO) availability     which is thought to play an important role in their progressive vascular disease.      Tetrahydrobiopterin (BH4), an essential cofactor for endothelial nitric oxide synthase(eNOS),     an important regulator of NO and that is a key mediator of endothelial dysfunction. Changes     in NO availability are believed to contribute to endothelial dysfunction seen in CKD and     common CVD states. 6R-tetrahydrobiopterin (6R-BH4 or sapropterin dihydrochloride) is an     investigational oral drug that is being evaluated to determine whether it will restore NO     availability, leading to beneficial effects on vascular function and ultimately positive     clinical outcomes in patients with CKD. The primary endpoint in this study is the level of     albuminuria, an easily measured marker that has served as a predictor of kidney disease     progression. If 6R-BH4 reduces albuminuria in patients with kidney disease, it may have     implications to slow the disease progression as well as decreased risk of CVD.   "
212029|NCT00607893|"     Sleep-disordered breathing (SDB) is a condition in which a person experiences frequent     breathing pauses during sleep, also known as sleep apnea. There is evidence that the     recurrent sleep arousal and associated shortage of oxygen in the body may increase risk for     cardiovascular disease (CVD). It is believed that treatment with continuous positive airway     pressure (CPAP) may reduce certain risk factors for heart disease, including markers of     inflammation and oxidative stress. This study will evaluate the effectiveness of CPAP in     reducing CVD risk factors in people with SDB.   "
212030|NCT00607906|"     This study will use single escalating doses of SB756050 to assess safety, pharmacokinetics,     and pharmacodynamics in healthy volunteers and in subjects with Type 2 Diabetes Mellitus.   "
212031|NCT00607919|"     This study will evaluate the effect of atomoxetine in treating     Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with     ADHD and comorbid reading disability (dyslexia)   "
212032|NCT00607932|"     RATIONALE: Eating a diet high in vegetables may lower the risk of some types of cancer.     Brassica vegetables (such as cabbages, kale, broccoli, Brussels sprouts, and cauliflower) and     indole-3-carbinol (a substance found in cruciferous vegetables) may help lower the risk of     prostate cancer recurrence.      PURPOSE: This randomized clinical trial is studying the side effects and how well Brassica     vegetables work compared with indole-3-carbinol in treating patients with PSA recurrence     after surgery for prostate cancer.   "
212033|NCT00607945|"     The purpose of the study is to see how a dietary oil called conjugated linoleic acid, or CLA,     might be useful in combination with diabetes medication. Some studies show that CLA can     modestly reduce body weight and body fat. Our research idea is that taking CLA will reduce     body weight and body fat without interfering with the diabetes medications' effects on blood     sugar.   "
212060|NCT00619268|"     The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a     combination of Torisel® and Avastin® given at first-line treatment in patients with     metastatic renal cancer.      Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®,     or Sutent® or IFN+Avastin®.   "
212140|NCT00629759|"     The primary purpose of this study is to determine the maximum tolerable dose (MTD) and/or the     maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 (Pexa-Vec) injected     within hepatic carcinoma tumors.   "
212034|NCT00607958|"     Tipranavir is a drug with a high antiretroviral activity, also in presence of major mutations     in the protease gene. However, its necessity of being co-administered with 400 mg of     ritonavir daily, limits its efficacy for the treatment of HIV-infected patients, due to the     high incidence of gastrointestinal adverse events. Nevertheless, tipranavir plasma though     concentrations were higher than the proposed minimum effective concentration for patients     with previous experience with protease inhibitors (PI) in half of patients treated with     tipranavir/ritonavir at 500/100 mg dose every 12 hours. Furthermore, when the number of     mutations in the protease gene is limited, there are no differences in the reduction of the     viral load between patients treated with tipranavir/ritonavir at 500/200 mg and 500/100 mg     every 12 hours. At last, the efficacy of tipranavir treatment has been more closely related     with the inhibition quotient (IQ) than with concentrations considered isolated.      Considering the previous arguments, it can be hypothesized that, basing in every subject IQ,     it could be possible to identify those patients HIV-infected in treatment with     tipranavir/ritonavir at 500/200 mg every 12 hours that could take advance of the reduction of     ritonavir to 100 mg every 12 hours, without compromising the viral replication control. This     strategy could improve the tolerability to the treatment, what could result in a better     adherence and less proportion of treatment abandon due to this reason   "
212035|NCT00607971|"     The main purpose of this study is to evaluate the long-term safety and tolerability of     renzapride at a dose of 4 mg taken once daily for 12 months in women with     constipation-predominant irritable bowel syndrome (IBS-C).   "
212036|NCT00607984|"     The prognosis of children and adolescents with high risk tumors of the central nervous system     and other miscellaneous solid tumors is poor despite modern treatment protocols. Frequently,     physicians suggest additional therapy with high dose chemotherapy after a good initial     response to standard doses of treatment has been obtained, so as to reduce the chance that     the tumor will recur. We propose a regimen of high dose thiotepa and melphalan followed by     rescue of the patient's previously stored hematopoietic (blood manufacturing) system with     blood stem cells. The aim of this study is to prove that this therapy is tolerable in     children and adolescents, that it results in tolerable levels of toxicity, and that it     improves the survival of this group of children as compared to standard therapy given in the     past   "
212037|NCT00607997|"     This study will evaluate the overall remission rate of treatment with vosaroxin (formerly     voreloxin) Injection in patients at least 60 years of age with previously untreated AML   "
212038|NCT00608010|"     Embryo preservation through freezing plays a significant role in human assisted reproduction.     It provides an opportunity for patients to have more than one attempt following an ovarian     stimulation cycle, thereby decreasing the exposure of patients to exogenous gonadotrophins     and improving cumulative pregnancy rates. The purpose of this study is to compare     effectiveness of two different freezing methods.   "
212041|NCT00608049|"     Cardiovascular disease (CVD) and diabetes are health conditions that are strongly influenced     by a person's diet. Although the best diet to prevent CVD and diabetes is uncertain, reducing     intake of saturated and transunsaturated fats is known to help lower cardiovascular risk.     However, even diets low in these fats can vary widely in other energy providing nutrients,     particularly carbohydrates. This study will determine the effects of a higher versus lower     carbohydrate diet, each with a high or low glycemic index (GI) composition, on risk factors     for CVD and diabetes.   "
212042|NCT00608062|"     The purpose of this study is to find out why women's arteries stiffen as they go through     menopause, and how this is affected by estrogen loss. We believe that arteries stiffen with     the loss of estrogen because of oxidative stress, the production of molecules that can     damage cells and tissues in the body, and because the arteries lose their ability to expand,     or dilate.   "
212043|NCT00608075|"     The purpose of the research is to study brain structure, function and chemistry of patients     with bipolar disorder who are receiving lithium, an FDA-approved treatment for bipolar mania,     in order to better understand who benefits from treatment and why they respond to     medications. Studying this may help improve treatment and outcome in patients with bipolar     disorder.   "
212044|NCT00608088|"     This research was done to better understand how new mothers who are breastfeeding feel and     the questions they have. We wanted to use ways to help new mothers to breastfeed     successfully. We compared a new approach (home visits and telephone calls) to the usual care     given at Johns Hopkins Hospital with strong support to new mothers from nurses, and a peer     counselor (another mother with breastfeeding experience).   "
212045|NCT00608101|"     The purpose of this study is to determine what corticosteroid receptor (and the dose of) is     responsible for cortisol inducing hypoglycemia associated autonomic dysfunction in Type 1 DM.     Specifically, we aim to determine whether stimulating the type 1 corticosteroid receptor (via     fludrocortisone), the type 2 corticosteroid receptor (via dexamethasone), or both causes     hypoglycemia associated autonomic dysfunction in Type 1 DM.   "
212061|NCT00619281|"     Low output syndrome is a common complication in patients undergoing cardiac surgery. Its     incidence was reported to be 2 to 6% [1]. Morbidity and mortality of low output syndrome is     high and the costs for treating the disease are immense.      The primary objective of this prospective observational study is to define a threshold for a     critically reduced cardiac output requiring immediate therapy.   "
213679|NCT00650338|"     To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering     intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular     Hypertension   "
212046|NCT00608127|"     Systemic Lupus Erythematosus (SLE) is a chronic, autoimmune, inflammatory disease primarily     affecting women of childbearing age, and associated with severe morbidity and mortality of     its victims. The existing therapy, however, is not specific and its inevitable side effects     may themselves be fatal. Therefore, it is a widely recognized need for, and it would be     highly advantageous to have a safe, specific rapidly effective and well-defined treatment of     SLE, devoid of the disadvantages.      We have shown that VRT101 a peptide present in the extracellular laminin is a target for     pathogenic lupus autoantibodies. Using this peptide we have developed the LupusorbTM - an     immune-adsorption column which specifically binds pathogenic antibodies from monoclonal     cultures as well as from patients` plasma. The investigational product named LupusorbTM     Column is a sterile medical device for single use and can be classified into category IIb     (synthetic ligands, peptides) according to Annex IX of the European Medical Device Directive     42/93/EEC.      The proposed study, a pilot non-randomized open label study, will test the safety,     Tolerability and short term efficacy of a single immunoadsorption procedure in SLE patients.   "
212047|NCT00608140|"     Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the     heart's mitral valve, located between two of the heart's main chambers, does not firmly shut,     allowing blood to leak backwards within the heart. Improper functioning of the mitral valve     disrupts the proper flow of blood through the body, resulting in shortness of breath and     fatigue. When mild, MR may not pose a significant danger to a person's health, but severe MR     may be associated with serious complications, such as heart failure, irregular heart rhythm,     and high blood pressure. Although there are treatments for MR, including medication and     surgery, more information is needed on the effectiveness of these treatments in people with     significant MR. This study will compare the safety and effectiveness of corrective surgery     added to optimal medical treatment (OMT) versus OMT alone in treating people with significant     MR caused by an enlarged heart.   "
212048|NCT00608153|"     The CoCa study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg     candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions,     i.e. under routine medical care conditions, the subject compliance as well as the efficacy     and tolerability of candesartan or candesartan/HCT in subjects suffering from essential     hypertension.   "
212049|NCT00608179|"     This study will look at two FDA approved medications that improve how the pancreas works in     patients with Type 2 Diabetes. In order to understand how these medications work in patients     with diabetes we must first measure the normal response in healthy volunteers without     diabetes. We will be looking at the body's normal physiological response to low blood sugar     and whether this will be modified by these medicationsThe hypothesis would be that     glimepiride induced insulin secretion will be inhibited by hypoglycemia.   "
212050|NCT00608192|"     This randomized clinical trial will examine the effectiveness of a strategy of HIV and     Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and     vaccination for methadone maintenance patients compared with standard Testing, Education, and     Counseling (TEC).   "
212051|NCT00608205|"     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is     not yet known whether radiation therapy and cisplatin are more effective with or without     fluorouracil in treating patients with head and neck cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to     compare how well they work with or without fluorouracil in treating patients with stage III     or stage IV head and neck cancer.   "
212052|NCT00608218|"     The aim of the study is to evaluate the efficacy of ciclesonide in patients with persistent     asthma over 3 months, especially in the cold season. Ciclesonide will be inhaled by a     metered-dose inhaler. The study will provide further data on safety and tolerability of     ciclesonide.   "
212053|NCT00608231|"     To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for     awake, DBS surgery has no significant effect on electrophysiological parameters of DBS     micro-electrode recordings   "
212054|NCT00608244|"     A three sequence, open-label, multi-center, prospective, study in stable liver transplant     patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of     LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.   "
212055|NCT00608283|"     Kidney transplants from living donors now account for 40% of all the kidney transplants done     in the United States. However, the current information on how donating a kidney can affect     the donor's long term health needs further investigation. The purpose of this study is to     collect data on a large number of live kidney donors and create and analyze a comprehensive     database. Information about the number of living kidney donors, including those who have     experienced kidney failure, heart problems, and death will be gathered for the database.     Investigators will then use the database to identify the risks of kidney failure, associated     conditions, and death after living donation. The database will also be used to identify     characteristics that put donors at higher risk for health problems after donation.   "
212056|NCT00608296|"     The purpose of the research is to study brain structure, function and chemistry of patients     with bipolar disorder who are receiving quetiapine or lithium, in order to better understand     who benefits from treatment and why they respond to medications.   "
212057|NCT00608322|"     The purpose of this study is to determine whether inhaled nitric oxide is an effective     treatment for microcirculatory dysfunction and acute organ system failure in the early stage     of sepsis therapy.   "
212058|NCT00608335|"     Children with fungal infections will be divided into two groups by weight. Children weighing     < 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days     than children weighing > 25 kg.   "
212059|NCT00619255|"     Recent needs assessments suggest that difficulties exist in care coordination between     emergency medical services (EMS) systems and primary care for injured adolescents with     alcohol problems and post-traumatic stress disorder (PTSD). This project will implement,     evaluate, and disseminate the adolescent trauma support service model program that aims to     enhance coordination between EMS systems and primary care/community services.   "
212062|NCT00619294|"     Non-obstructive coronary artery disease (NOCAD) frequently accounts for myocardial ischemia     in women. Endothelial dysfunction is a pathogenic factor in coronary spastic angina (CSA).     CSA is an important cause of NOCAD diagnosed invasively by coronary angiography (CAG).     Digital reactive hyperemia peripheral arterial tonometry (RH-PAT) provides noninvasive     evaluation of endothelial dysfunction. The investigators hypothesized that the fingertip     RH-PAT could predict the presence of CSA in women.   "
212063|NCT00619307|"     To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in     patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected     interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while     receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence     of flu-like symptoms.   "
212064|NCT00619320|"     This study will examine safer sex skills building (SSB), a targeted behavioral HIV prevention     and risk reduction group intervention in two samples of pregnant drug abusing women.   "
212065|NCT00619333|"     The aim of the study is to investigate whether inactive FSH plays a role in the development     of Premature Ovarian Failure in women with Classic Galactosemia   "
212066|NCT00619346|"     This is a phase 1 study to establish the safety and tolerability profile of pafuramidine     maleate 100 mg BID administered orally for 14 days to healthy subjects   "
212067|NCT00619359|"     The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to     prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin     chemotherapy.   "
212068|NCT00619372|"     This clinical study is designed to evaluate the safety of oral administration of the study     drug anti CD3 (OKT3) in combination with β-D glucosylceramide [GC] .   "
212069|NCT00619385|"     Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg   "
212070|NCT00619398|"     This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf®     in stable liver transplantation patients. It shall be demonstrated that FK506MR is     non-inferior to Prograf® with regards to the efficacy and safety.   "
212071|NCT00619411|"     The purpose of this study is to examine the feasibility and acceptability of an adaptation of     Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) that includes greater and more     structured involvement of the parents in the treatment.   "
212072|NCT00619424|"     This is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and     tolerability and to determine the maximum tolerated dose (MTD) of pazopanib in combination     with erlotinib (Arm A) or pazopanib in combination with pemetrexed (Arm B) in patients with     advanced solid tumors. Patients will be enrolled in cohorts of 3 (in each arm) to receive     escalating doses of pazopanib and erlotinib or pazopanib and pemetrexed. Dose escalation     schemas for each study arm are described in the protocol. For each arm, the MTD regimen will     be defined as the highest dose combination of the agents where no more than one out of six     patients experiences a dose-limiting toxicity. Six to twelve additional patients in each arm     will be studied with the MTD regimen to evaluate toxicity and pharmacokinetics. In arm A     (erlotinib), a run-in phase with each drug separately will allow an evaluation of     pharmacokinetics with each drug separately and also for the two drugs in combination. This     will allow an assessment of potential drug-drug interactions. Pharmacokinetic endpoints will     be AUC, Cmax, tmax and t1/2 of pazopanib, erlotinib, and pemetrexed, as well as pemetrexed     clearance before and after administration of pazopanib in the extension cohort of Arm B.     Antitumor activity will be assessed using RECIST criteria.   "
212267|NCT00631423|"     The purpose of the study is to evaluate patients with inferior vena cava (IVC)thrombosis in     terms of etiology, clinical course and prognosis during long-term follow-up. Patients with     isolated lower extremity DVT, matched for age and gender, serve as controls.   "
212073|NCT00619437|"     Genetic etiology in schizophrenia is widely accepted. However, many chromosomal sites were     shown to characterize the families of patients with schizophrenia. This is probably due to     the high genetic heterogenity of this illness. Thus, it is important to investigate the     genetic factor in relatively genetically homogenous populations. Many studies have indicate     that Ashkenazy Jews show relative gentic homogenity. Indeed, the genes responsible for most     Mendelian disorders of Jewish peoples have been identified. The study will apply genome-wide     mutation screening methods to identify candidate allells in subjects of Ashkenazi Jewish     ancestry with multiplex schizophrenia.   "
212074|NCT00619450|"     The purpose of this study is to determine the optimal images of the heart structures which     are used to guide AF ablation or BiVenticle and coronary vessels.   "
212075|NCT00619463|"     The purpose of the study is to determine the efficacy of aerobic exercise for improving     cognition, mood, and fatigue after Traumatic Brain Injury (TBI) as well as examine the role     of Brain Derived Neurotropic Factor (BDNF) and peripheral Vascular Endothelial Growth Factor     (VEGF) as mediators of response to exercise.   "
212076|NCT00619476|"     The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262),     hereafter referred to as GEn is effective in the treatment of neuropathic pain associated     with post-herpetic neuralgia (PHN).   "
212077|NCT00619489|"     This was an open-label study to provide an opportunity for participants with Ulcerative     Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve     participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to     determine the long term safety of vedolizumab in patients afflicted with these diseases.   "
212078|NCT00619502|"     This is a follow-up of Study A3L10 (NCT00315055)      Immunogenicity        -  To describe the antibody persistence following a primary series vaccination of either          DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.        -  To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T.      Safety      - To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.   "
212079|NCT00619515|"     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor     and cause less damage to normal tissue.      PURPOSE: This trial is studying the side effects of stereotactic radiation therapy and to see     how well it works in treating patients with prostate cancer.   "
212080|NCT00619528|"     The purpose of this study is to attempt to eliminate the necessity of immunosuppressive     therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor     hematopoietic stem cell (DHSC) lineages for pairs to demonstrate immunologic     unresponsiveness, and to investigate the safety and efficacy of the treatment regimen     including withdrawal of immunosuppression after one year post-transplant for those recipients     having received DHSC infusions.   "
212083|NCT00619567|"     There has been little success in treating the cognitive (thinking) problems associated with     HIV/AIDS using medications. The purpose of this study is to determine whether an     internet-based cognitive stimulation program might help HIV-infected individuals think more     clearly. If this is true, then it means that people with mild forms of cognitive impairment     may be able to help themselves to get better.   "
212084|NCT00619580|"     The information collected will optimize the management of patients with gram negative     bacteremia. Approximately 300 patients with Gram negative bacteremia are cared for each year     at UPMC-P. Published medical literature suggests that mortality from this infection exceeds     20%. The aim of this research is to determine the risk factors for bacteriologic failure of     antibiotic therapy, risk factors for antibiotic resistance in bloodstream isolates and risk     factors for mortality from Gram negative bacteremia. Modifiable risk factors can then be     tackled by a future interventional study.   "
212085|NCT00619593|"     The MADIT-II trial has shown that patients with severely reduced left ventricular ejection     fraction (LVEF) post myocardial infarction benefit from the implantable     cardioverter-defibrillator (ICD). However, retrospective analyses of the MADIT-II data have     revealed a significantly increased morbidity and mortality in patients with appropriate ICD     therapy: Appropriate ICD therapy is associated with 3.3-fold increased all-cause mortality,     and the risk of a first heart failure hospitalization is 90% higher after 1st appropriate ICD     therapy. Hence, the 1st appropriate therapy might indicate the necessity and utility of     further clinical diagnostics and therapy in these patients.      This trial is designed to (i) improve the knowledge of the group characteristics of patients     suffering from 1st appropriate ICD therapy, (ii) but moreover to take additional therapeutic     steps to reduce the mortality of this patient population.   "
212086|NCT00619606|"     A comparative study which compares the end-tidal carbon dioxide and oxygen saturation levels     of patients during endoscopy which have used either the new oral-nasal oxygenating device     (TwinGuard), or a standard bite block plus nasal cannulae using an equivalent flow rate of     oxygen.   "
212087|NCT00619619|"     The primary purpose of this study is to test the safety and tolerability of single ascending     doses of Desvenlafaxine Succinate Sustained-Release (DVS SR) in both child and adolescent     outpatients with major depressive disorder. This study will also characterize the     pharmacokinetic profile of DVS SR in children and adolescents with major depressive disorder.   "
212100|NCT00625885|"     The purpose of this study is to determine the effects of modifiable risk factors on     patient-reported quality of life, physical activity levels, and risk of early osteoarthritis     following revision anterior cruciate ligament (ACL) reconstruction.      The investigators hypothesize that modifiable variables exist at the time of revision ACL     reconstruction (e.g., cause of failure, current graft source and type, surgical exposure, and     femoral and tibial tunnel position) which will be predictors of patient-reported outcomes.   "
212101|NCT00625898|"     The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in     patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.   "
212102|NCT00625911|"     Thoracotomy for lung tumor or for minimally invasive direct coronary artery bypass (MIDCAB)     surgery, may be associated with debilitating pain. Ketamine was shown to enhance opioid     antinociception and prevent opioid resistance. We hypothesize that ketamine given with     morphine would lower morphine consumption and narcotic related side effects after thoracotomy     and provide superior analgesia to morphine given alone.   "
212408|NCT00632697|"     To prove efficacy of an immunomodulator called pentoxifylline in the treatment of     endometriosis in infertile patients undergoing laparoscopy surgery   "
212088|NCT00619632|"     This is a randomized, controlled, single-center, single-blind, 2x2 factorial design trial of     routine provider, primary care-based interventions to increase breastfeeding intensity up to     6 months in low-income multiethnic women, with stratification for maternal country of birth.     The Best Infant Nutrition for Good Outcomes (BINGO) trial will randomize women into one of     four treatment groups: (a) Prenatal Care Provider (PNC); (b) Lactation Consultant (LC); (c)     PNC + LC, or; (d) Control. Thus, the separate and synergistic effects of the interventions     will be tested, compared to a Control standard of care. The intervention and design build     upon our prior trial of an LC intervention alone.      PNCs— certified nurse midwives and ob/gyns-- will use a brief, electronically prompted     protocol with women in the PNC, and PNC + LC groups throughout pregnancy. An LC will arrange     pre-natal one-on-one meetings, daily hospital, and home visits with women in the LC and     PNC+LC groups. Descriptive data on infant health visits, and participant/provider experiences     will be collected as secondary outcomes. Interviews at 1,3 and 6 months post-partum will     collect infant feeding, and health visit data outside the medical center. Medical center     visit data will be obtained from MIS data.      Primary Outcomes (Hypotheses): Breastfeeding        1. Breastfeeding Intensity at 1,3, and 6 Months        2. Exclusive Breastfeeding at 1,3, and 6 Months           Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience        3. To describe the frequency and timing of infant health visits for breast-feeding          sensitive illnesses        4. To describe participant and provider (LC and PNC) experience of the interventions.   "
212089|NCT00619645|"     Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem     cell transplant helps stop the growth of cancer cells. It also stops the patient's immune     system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor     effect). Sometimes the transplanted cells from a donor can also make an immune response     against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and     after the transplant may stop this from happening.      PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem     cell transplant together with fludarabine and busulfan and to see how well it works in     treating patients with hematologic cancers.   "
212090|NCT00619658|"     To assess the feasibility of using simplified telephone follow-up to predict pregnancy     expulsion after medical abortion, and if in-person follow-up is required to determine the     percentage of women that will present for that follow-up.   "
212091|NCT00619671|"     Myasthenia gravis is a disease that happens because the immune system attacks the nervous     system. The damage is caused by antibodies produced by B lymphocytes. These antibodies damage     a special part of the muscle that helps transmit impulses from nerves to muscles to allow     muscles to work properly. This damage results in symptoms of myasthenia gravis. Participants     are being asked to participate in this research study because their myasthenia gravis has     either failed to respond to treatments commonly used in the disease, or they have had bad     side-effects from such treatments.      This is a research study of a drug called Rituximab. Rituximab, also called Rituxan, is a     mouse antibody that has been changed to make it similar to a human antibody. Antibodies are     proteins that can protect the body from foreign invaders, such as bacteria and viruses, by     binding to substances called antigens. Rituxan works by binding to a protein, called the CD20     protein. Rituxan helps to destroy white blood cells that produce antibodies in the body,     called B-lymphocytes. It is a treatment given through a vein in the participant's arm over a     period of approximately 4-6 hours. It has been approved by the Food and Drug Administration     (FDA) for use in patients with a form of cancer of the lymph glands called Non-Hodgkin's     Lymphoma (NHL). Rituximab is not approved for their myasthenia gravis.      Treatment with Rituximab is being tried in this research study because Rituximab decreases B     lymphocytes. There is preliminary evidence that Rituximab helps some patients with chronic     and otherwise difficult to treat myasthenia gravis.   "
212095|NCT00619723|"     A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial of citicoline     as an add-on therapy will be conducted in 200 outpatients with bipolar I disorder and cocaine     dependence. Patients will complete mood and memory assessments weekly, in addition to     completing self-report measures for cocaine (and other substances, like alcohol) use and     craving. Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two     sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically     designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist     with experience in CBT. The sessions may be videotaped for training purposes and may be     viewed by the researchers, the therapist, and Dr. Schmitz, a clinical researcher at the     University of Texas Houston who is the developer of the CBT for bipolar disorder and     substance dependence used in the study. Before being videotaped, the patient will sign an     Authorization for Audio Recordings, Photography, or Other Images for Non-Treatment Purposes     to further understand how the videotape will be used, and by whom. The patient will be given     the option to review their videotape to view their therapy session. Once the patient has     completed all study procedures, or had discontinued the study, the tape will be destroyed,     until then the tape will kept in the patient's confidential study file. Further, patients     will return to the clinic three times a week for urine drug tests (UDS). 200 patients are     expected to be consented for this study and all study procedures will take place at the     clinic on the University of Texas Southwestern Medical Center campus.      All non-study medications are not part of the study. Non-study medication will be verbally     self-reported by the patient at the time of enrollment into the study. The patient will be     responsible for the costs of their non-study related medications. The patient will manage     their non-study medications with their personal doctor, including any changes in these     medications. However the protocol has concomitant medication algorithm in the event that a     change in the medication schedule needs to be made by a study doctor. If a study doctor     requests a laboratory test for the patient, it will be paid for by the clinic. Otherwise, the     patient will be responsible for all costs (including laboratories) associated with their     non-study medications.   "
212096|NCT00625833|"     This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving     chronic peripheral pain suffered by patients with diabetes. Some evidence for the     effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed     trials.   "
212097|NCT00625846|"     This phase II trial studies the side effects and how well pazopanib hydrochloride works in     treating patients with advanced thyroid cancer. Pazopanib hydrochloride may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood     flow to the tumor.   "
212098|NCT00625859|"     The purpose of this research study is to look at concentrations of GSK189075, WELLBUTRIN SR     and active metabolic products in blood samples when doses of both drugs are taken by mouth.     Doses are either taken alone or together. The results will help to determine if doses of     GSK189075 and WELLBUTRIN SR can be safely taken together.   "
212099|NCT00625872|"     The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or     0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive     performance.   "
212104|NCT00625937|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     more than one drug (combination chemotherapy) together with radiation therapy may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with     radiation therapy and low-dose cisplatin works in treating patients with stage III or stage     IV head and neck cancer.   "
212105|NCT00625950|"     Dopamine agonists, such as quinagolide, are able to act on the VEGFR-2 blocking antibodies,     diminishing Vascular Endothelial Growth Factor effect on angiogenesis in human endometriotic     lesions.   "
212106|NCT00625963|"     Current standard of the diagnosis and monitoring of PHNT requiring combination of invasive     and non-invasive tests. The goal of the study is to correlate data from CT scans,     echocardiograms, right heart catheterization, PFTs, sleep studies, and perfusion scans. The     ultimate goal is to determine patterns of the PAH disease processes.   "
212107|NCT00625976|"     Background:      Research on the treatment of CRPS-I, as described in the Dutch evidence based treatment     guidelines (Richtlijn Complex Regional Pain Syndrome type I, 2006), mainly showed improvement     at the level of pain and coping with pain. Only little improvement in functional restoration     was found. Research in other pain populations such al neck- and back-pain patients has shown     that pain related fear contributes to the development of functional disability. GEXP in vivo     which aims on systematically reducing fear of movement, shows promising results in CRPS-I     patients (de Jong et al., 2005).      Objective:      The objective of the proposed project is to compare the effectivity of GEXP in vivo with that     of standardized physiotherapy in CRPS-I patients with pain related fear.      Design:      The study concerns a single blinded, single center, randomized clinical trial. The treatment     will be preceded by two pre-measures. After treatment there will be one post-measurement and     3, 6 and 12 month follow-up measurements.      Population:      The study population will consist of chronic CRPS-I patients between 18 and 65, with pain     related fear (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32).      Intervention:      The two interventions that will be compared are GEXP in vivo (de Jong et al., 2005) and     standardized physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo en     Goris (1999). The GEXP in vivo comprises 17 sessions of one hour, the physiotherapy treatment     of 34 sessions of 30 minutes. Both treatments will be given over a period of 17 weeks.   "
212186|NCT00630357|"     A cohort of patients who became seizure-free during add-on treatment to one standard AED with     Keppra in a previous trial (N01031) were followed to assess whether seizure freedom was     maintained. Tolerability was documented.   "
212108|NCT00625989|"     Summary:      A picture is emerging of dendritic cells migrating through the blood to the airways following     allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present     novel findings, both do not provide a comprehensive view of sputum DCs following allergen     challenge. Therefore, the proposed study will examine the kinetics of mDCs and pDCs in the     induced sputum of atopic asthmatics following inhalation of allergen.      Hypothesis:      Following allergen challenge, sputum myeloid and plasmacytoid DCs will migrate into the     airway lumen in atopic asthmatics during the timeframe of the late asthmatic response.      Objective:      The objective of this study is to examine the kinetics of dendritic cells in induced sputum     following allergen challenge in atopic asthmatic subjects.   "
212109|NCT00626002|"     The purpose of this study is to evaluate long term safety, efficacy and tolerability of     ABT-874 in adults with moderate to severe psoriasis.   "
212110|NCT00626015|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Vaccines may help the body     build an effective immune response to kill tumor cells. Monoclonal antibodies, such as     basiliximab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. It is not yet known whether giving chemotherapy, radiation therapy, and     vaccine therapy together with basiliximab is a more effective treatment for glioblastoma     multiforme than chemotherapy, radiation therapy, and vaccine therapy alone.      PURPOSE: This randomized phase I trial is studying the side effects and best way to give     chemotherapy and radiation therapy followed by vaccine therapy with basiliximab in treating     patients with glioblastoma multiforme that has been removed by surgery.   "
212111|NCT00626028|"     A minimum of 100 patients will be enrolled in the study to demonstrate which diagnostic     treatment (oxygen or nitric oxide) is most capable of identifying patients with a reactive     pulmonary vascular bed. Each patient will be given all three treatment regimen, nitric oxide,     oxygen, and the comparison treatment (nitric oxide plus oxygen), with a wash out period of 10     minutes between each dose. Patients will be randomized at the time of enrollment to determine     which comparison treatment they will receive.   "
212112|NCT00626041|"     High blood pressure, elevated blood glucose and high cholesterol are related to the increased     risk of stroke and heart disease. Many studies have shown that this risk can be significantly     reduced by lowering blood pressure, blood glucose and cholesterol levels.      Through a collaborative effort between Calgary Safeway pharmacists and Calgary Health Region     family physician PCN's, U-CHAMP will deliver a program to assist in the identification and     management of people with elevated blood pressure, blood glucose and cholesterol and through     this effort, reduce the risk of heart disease and stroke in the urban Calgary population aged     18-85 years.   "
212113|NCT00626054|"     The purpose of this study is to compare the effectiveness (quality of bowel cleansing) and     ease of use (patient satisfaction) of two methods of administration of a precolonoscopy PEG     solution in hospitalized patients.   "
212114|NCT00626067|"     The primary objective of this study is to determine the opinions of patients who are given     the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma     drops.   "
212115|NCT00626080|"     The aim of this study is to test the hypothesis that subcutaneous administration of insulin     detemir, as compared to insulin NPH, leads to a more pronounced effect on cerebral glucose     metabolism and/or cerebral blood flow in brain regions associated with appetite regulation,     to account for the reported difference in weight.   "
212116|NCT00626093|"     The purpose of this prospective study is to evaluate the effect of cardiac resynchronization     therapy (CRT) on the defibrillation threshold (DFT) estimates in cardiac resynchronization     therapy defibrillators (CRT-D) patients. The hypothesis of the study is that defibrillation     threshold (DFT) will decrease with 6 months of cardiac resynchronization therapy (CRT).   "
212117|NCT00626106|"     This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include     postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast     cancer, who have disease progression during or within 12 months after completing prior     adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic     disease.   "
212118|NCT00626119|"     RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an     effective method of finding microcalcifications and lesions in the breast.      PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in     finding breast microcalcifications and lesions in women.   "
212119|NCT00626132|"     The purpose of this study is to demonstrate that eucommia, an herb used in China for making     tea, is safe and effective for lowering blood pressure in humans with high blood pressure.   "
212120|NCT00626145|"     The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI)     is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed     the short term outcome of bone marrow stem cell transplantation for MI patients, but rare     report of long term follow-up results. Our aim was to investigate 4 years' efficacy and LV     functional improvement of autologous bone marrow mononuclear cells (BMMC) transplantation in     patients with ST-elevation myocardial infarction.   "
212121|NCT00626158|"     The purpose of this study is to find out what effects gemcitabine plus capecitabine has on     patients with pancreatic or biliary cancer, and to determine the optimal dose that can be     given safely of these two drugs together (called the maximum tolerated dose). Gemcitabine and     capecitabine are two chemotherapy drugs used to treat pancreatic and biliary cancer. These     two drugs used together are considered an acceptable standard of care for pancreatic and     biliary cancers. However, in this study the dose and dosing schedule will be changed, in the     hopes that the drugs will have more effect with fewer side effects than when given in the     standard way.   "
212122|NCT00629525|"     The purpose of this study is to determine the biochemical response rate (PSA) to single agent     RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC).   "
212187|NCT00630370|"     To assess the efficacy of 3 oral dosing regimens of ATI 7505 compared to placebo in patients     with PDS by comparing at the end of Day 42 the percentage of patients in each treatment group     who have had adequate relief of postprandial distress syndrome symptoms on at least 50% of     the treatment days.   "
212123|NCT00629538|"     Transudative pleural effusions are a common manifestation of patients with congestive heart     failure. Severe dyspnea and respiratory failure may develop in those with large effusions,     which in general show poor response to medical treatment. Therapeutic thoracenteses (TT) may     be indicated in these patients and can produce marked relief of symptoms. However, the     underlying effect of TT on gas exchange and respiratory mechanics in theses patients remains     unclear. The researchers' hypothesis is that,TT may improve arterial oxygenation and     respiratory mechanics in patients with congestive heart failure complicated by large pleural     effusions.   "
212124|NCT00629551|"     The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once     daily in combination with paroxetine 20mg once daily compared to saredutant placebo in     combination with paroxetine 20mg once daily in patients with major depressive disorder. The     study also includes a double-placebo group (saredutant placebo in combination with paroxetine     placebo).   "
212125|NCT00629564|"     This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg     Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people     with symptoms of Gastroesophageal Reflux Disease (GERD)   "
212126|NCT00629577|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research trial is studying gene expression profiling of cervical cancer     progression in biopsies and tissue samples from patients with cervical lesions.   "
212127|NCT00629590|"     The purpose of this study is to evaluate the safety and efficacy of AzaSite ophthalmic     solution, 1% on signs and symptoms of blepharitis.   "
212128|NCT00629603|"     Hepatitis C virus (HCV) infection causes different disease spectrum ranging from minimal     progressive liver disease to cirrhosis or hepatocellular carcinoma. Evidence indicates that     host genetic factor may play a role in determining disease progression. It is known that many     cytokine polymorphisms affect disease progressin via increasing hepatic fibrosis that are key     factors in progressing liver injury. By combinations of fibrosis-relating gene polymorphisms,     this study aims to identify patients with high risk for progressive liver disease. These     patients need intensive therapy to decrease morbidity and mortality of chronic HCV-related     liver disease.   "
212129|NCT00629616|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the     body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy     before surgery may be an effective treatment for breast cancer. It is not yet known whether     anastrozole is more effective than fulvestrant when given before surgery in treating women     with breast cancer.      PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works     compared with fulvestrant in treating postmenopausal women with stage II or stage III breast     cancer that can be removed by surgery.   "
212130|NCT00629629|"     This study assesses the effectiveness of a nutrition advice programme - The ten steps for     healthy feeding of children under than two years - on nutritional status and morbidity     history of children. This is a randomized controlled trial in mostly socioeconomic deprived     families (intervention=200; controls=300). Mother's of the intervention group received     dietary counseling in the first year of life. Both groups received routine care by their     paediatricians and research assessment at 6 and 12 months.   "
212283|NCT00631631|"     The purpose of this study was to collect information regarding the safety and tolerability of     mifamurtide (liposomal muramyl tripeptide phosphatidyl ethanolamine; L-MTP-PE).   "
212132|NCT00629655|"     The spinal cord is a very important part of the central nervous system. fMRI can be applied     to observe functional status of the human spinal cord. Under different conditions, the     investigators will see different types of fMRI signals within the spinal cord. In resting     state, the investigators might see active/inactive signals, too.   "
212133|NCT00629668|"     The prognosis of Hepatitis B virus (HBV)infection varies from minimal progressive liver     disease to cirrhosis or hepatocellular carcinoma (HCC).Both viral and host genetic factors     contribute to disease severity. Cytokine gene polymorphism has been regarded affecting     prognosis of disease. By detecting HBV genotyping and tumor necrosis factor-alpha     polymorphism, this study aime to assess their effects and interaction on disease severity of     HBV-related chronic liver disease and HCC.   "
212134|NCT00629681|"     The purpose of this study is to assess the efficacy and safety of pregabalin for the     treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN)   "
212135|NCT00629694|"     It is not unusual for several children operated for severe adenoid hyperthrophy causing     breathing problems to have otitis media with effusion simultaneously. It is unknown whether     adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy     alone in terms of otitis media related quality of life and recurrence of otitis media several     months after the operation. For this purpose a randomized trial is conducted including     children operated for adenoid hyperthrophy and whose otitis media with effusion had caused     minimal or no symptoms so far   "
212136|NCT00629707|"     The purpose of this trial is to compare two different rates of fluid administration during     diabetic ketoacidosis (DKA) treatment in children to determine which fluid administration     rate is more beneficial for brain metabolism and for preventing or decreasing brain swelling     during DKA.   "
212137|NCT00629720|"     The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin     (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years     of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology     stratified into 2 age groups (2 to 7 years and 8 to 16 years).      The secondary objectives are to investigate the safety and tolerability of the 2 dose     regimens and to determine the effect of the 2 dose regimens on detrusor LPP.   "
212138|NCT00629733|"     Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular     weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male     volunteers   "
212139|NCT00629746|"     The purpose of this study will explore the advantages of electrodes used for monitoring of     the recurrent laryngeal nerve (RLN) in thyroid surgery   "
212188|NCT00630383|"     The aim of the study is to determine whether controlled infection with a clinically safe     number of larvae of hookworm results in an immune response that is protective in relapsing     MS.   "
212141|NCT00629772|"     Palmoplantar psoriasis is a variant of psoriasis affecting palms and soles. It is one of the     most debilitating variants of psoriasis which very often interferes with daily activities and     with the ability to work. This type of psoriasis is very difficult to treat as topicals have     difficulty penetrating the thick epidermis of palms and soles and are therefore not very     effective. The response to standard agents (methotrexate, cyclosporine and acitretin) is also     usually limited. A number of these patients have very severe hand and feet disease with mild     to no involvement elsewhere on the body.      Given the efficacy of infliximab in psoriasis, the purpose of this study is to evaluate if     infliximab is safe and if it will improve severity and quality of life in patients with     palmoplantar psoriasis, a debilitating variant of psoriasis.   "
212142|NCT00629785|"     The prevalence of obesity and asthma has increased in recent decades. We investigated the     relationship between body mass index (BMI) and lung function, and also tried to determine if     asthma prevalence differs between obese and non-obese children. We propose this     cross-sectional, retrospective analysis to figure out whether the BMI is associated with     elevated prevalence of asthma, and how their lung function changes in different BMI groups.   "
212143|NCT00629798|"     This study will see if the researchers can lower that risk by giving the patient Palifermin.     This drug helps protect the lining of the mouth, throat, and stomach. These areas typically     get sores or ulcers while the blood cell counts are very low. The patient can get infections     in or from these sores. Palifermin might also help the immune system recover faster. It is     currently approved for patients who receive their own stem cells. That is called an     autologous transplant. This study will test the use of Palifermin for T-cell depleted     allogeneic stem cell transplants.   "
212144|NCT00629811|"     This is a single-centre, double-blind, Placebo-controlled, randomised trial. Trial subjects     received four 1cm incisional wounds on the inner aspect of each upper arm (eight in total),     giving four pairs of anatomically matched wound sites per subject. Each subject acted as     their own control. One site from each anatomical wound pair was randomly treated with     intradermally administered avotermin (Juvista:100μL per linear cm of wound site     pre-operatively and 100μL per linear cm of wound margin post-wounding on Day 0 or Day 1,     400μL per wound site) while the second site was a paired control, treated with Placebo (100μL     per linear cm of wound site pre-operatively and 100μL per linear cm of wound margin     post-wounding on Day 0 or Day 1, 400μL per wound site). Wound margins for injection were     defined as extending 0.5cm from either end of the incision. Four doses of avotermin (Juvista)     were administered to each subject: 5ng, 50ng, 200ng and 500ng/100μL per linear cm; one dose     to one wound site per anatomically matched pair of wounds. The second wound site from each     anatomically matched pair of wounds was dosed with placebo. Allocation of treatment to     wound-site pairs was randomised and double blinded.      Primary objective To determine the optimal concentration and dose regimen of Juvista for the     improvement of the resultant scar when applied to the approximated wound margins of male and     female subjects following surgical incisions.      Secondary objective To assess the safety and tolerance of Juvista when applied to the     approximated wound margins of male and female subjects following surgical incisions.   "
212304|NCT00631917|"     This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren     (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.   "
212305|NCT00631943|"     The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients     with nerve pain   "
212145|NCT00629824|"     Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the     treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The     efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its     impact on the outcome in older patients with chronic hepatitis C deserve to be elucidated.      The purposes of this study are:        1. To evaluate the efficacy of pegylated interferon-alpha 2a plus ribavirin combination          therapy in older patients with chronic hepatitis C        2. To investigate the safety of pegylated interferon-alpha 2a plus ribavirin combination          therapy in older patients with chronic hepatitis C   "
212146|NCT00629837|"     The primary objective of this study is to determine the pharmacokinetic profile after single     administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22     mg and 13 mg of liposomes/Kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in     2.5 mL WFI/1000 IU) in PTPs aged 12 to 60 years with severe hemophilia A.   "
212147|NCT00629850|"     The purpose of this study is to determine if the use of a respiratory resistance trainer will     increase respiratory muscle strength, improve sleep quality and improve quality of life in     individuals with spinal cord injury.      Hypothesis: Use of the respiratory resistance trainer will improve respiratory muscle     strength, improve sleep quality, and improve quality of life among individuals with spinal     cord injury.   "
212148|NCT00629863|"     RATIONALE: Diagnostic procedures, such as endoscopic ultrasound, may help doctors learn the     extent of stomach cancer or esophageal cancer.      PURPOSE: This randomized clinical trial is studying how well endoscopic ultrasound works in     diagnosing cancer in patients with localized stomach cancer or esophageal cancer.   "
212149|NCT00629876|"     The purpose of this study is to determine the safety and tolerability of peginesatide used to     treat anemia in subjects diagnosed with recurrent non-small cell lung cancer, breast cancer     or prostate cancer and who also receiving a taxane chemotherapy.   "
212150|NCT00629889|"     RATIONALE: Levetiracetam and pregabalin are drugs that treat seizures. It is not yet known     which drug is more effective in treating seizures caused by primary brain tumors.      PURPOSE: This randomized phase II trial is studying the side effects and how well     levetiracetam or pregabalin work in treating seizures in patients undergoing chemotherapy     and/or radiation therapy for primary brain tumors.   "
212151|NCT00629902|"     The purpose of this study is to determine the frequency of prosthesis-patient mismatch after     mitral valve replacement and its effect on clinical outcomes.   "
212152|NCT00629915|"     The purpose of this study is to determine if people with moyamoya disease who have     insufficient blood flow are at a higher risk for stroke.   "
212153|NCT00629928|"     Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This     study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with     either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.   "
212154|NCT00629941|"     The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic     solution, 1% on signs & symptoms of blepharitis and tear cytokine and eyelid bacterial load     levels   "
212155|NCT00629954|"     This is a multi-site prospective epidemiological investigation of cardiovascular disease     (CVD) among Abuja residents from the rural and metropolitan area.   "
212156|NCT00629967|"     The purposes of this study are:        1. To evaluate whether treatment with peginterferon and ribavirin for 24 weeks is          sufficient to achieve a sustained virological response (SVR) rate comparable to that          observed with the standard treatment duration of 48 weeks, in hepatitis C virus genotype          1 (HCV-1) patients achieving a rapid virologic response (RVR; <50 IU/mL HCV RNA at week          4) at 4 weeks.        2. To investigate the role of on-treatment virological responses among patients with 24 or          48 weeks treatment.   "
212157|NCT00629980|"     The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic     solution, 1% on signs and symptoms of blepharitis.   "
212158|NCT00629993|"     Primary care physicians have an important role to play in the delivery of cancer prevention     and detection services to patients. Face-to-face counseling of physicians, called academic     detailing, involves a brief and focused intervention, modeled on the practices of     pharmaceutical companies. This type of intervention may increase physicians' attention to     preventive opportunities and increase their screening behaviors.   "
212159|NCT00630006|"     The prognosis of chronic hepatitis C virus (HCV)infeciton varies from minimal progressive     disease to cirrhosis or hepatocellular carcinoma. Host genetic factors contribute to disease     severity. It is known that cytokine gene (including tumor necrosis factor-alpha (TNF-alpha)     and interleukin-10 (IL-10) polymorphism affect disease prognosis.This study aims to assess     the effect of TNF-alpha and IL-10, and their interaction,on prognosis of HCV-related chronic     liver disease   "
212160|NCT00630019|"     Compare ocular tissue levels following topical ocular instillation of 1.5% levofloxacin     ophthalmic solution or an active comparator in subjects undergoing cataract surgery.   "
212161|NCT00630032|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) and giving them after surgery may kill any tumor cells     remaining after surgery. It is not yet known whether docetaxel is more effective than     ixabepilone when given after surgery and combination chemotherapy in treating breast cancer.      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed     by docetaxel or ixabepilone to compare how well they work in treating patients who have     undergone surgery for nonmetastatic breast cancer.   "
212162|NCT00630045|"     This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX     regimen (oxaliplatin plus capecitabine) .   "
212163|NCT00630058|"     The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and     other viral characteristics after administration of two arms of MP-424 in combination with     Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis     C.   "
212306|NCT00631956|"     The purpose of this study is to determine the progression evaluation, cardiovascular     outcomes, and genetic determinations of hypertension in Chinese   "
215957|NCT00670618|"     Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in     orthodontic patients during fixed appliances.   "
212164|NCT00630071|"     The values of laboratory examinations which are useful for the diagnoses of acute     appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood     sedimentation rate (ESR). Another laboratory value which has recently received considerable     attention for the early diagnosis of bacterial infection and sepsis is pro-calcitonin (PCT).     In recent studies it has been clearly shown that PCT is one of the most important biochemical     indicators which closely correlates with the severity of inflammatory host response to     microbial infections. Aim of this open, prospective study is therefore to investigate if PCT     has an accurate diagnostic value for the diagnosis of acute appendicitis.   "
212165|NCT00630084|"     Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the     treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The     efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its     impact on the outcome in chronic hepatitis C patients concomitant with malignancy other than     hepatocellular carcinoma deserve to be elucidated.      The purposes of this study are:        1. To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin          combination therapy in chronic hepatitis C patients concomitant with malignancy other          than hepatocellular carcinoma, compare to those without systemic malignancy.        2. To investigate the role of baseline and on-treatment factors on the response to          pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C          patients concomitant with malignancy other than hepatocellular carcinoma.   "
212166|NCT00630097|"     Patients treated for methamphetamine dependence have high rates of relapse, and no     pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d,     l-2-[(diphenylmethyl)sulfinyl]acetamide) is a novel wake- and vigilance-promoting agent that     is chemically and pharmacologically dissimilar to CNS stimulants. It is well tolerated and     has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety     of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive     function, has been shown to reduce cocaine use in dependent users, and is safe when     coadministered with intravenous methamphetamine. We will conduct a randomized dose ranging     clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for     methamphetamine dependence.   "
212167|NCT00630110|"     This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with     docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new     blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting     agents are intended to target the differences between these tumor blood vessels and the blood     vessels in normal tissues.   "
212168|NCT00630123|"     To investigate the change in brain derived neurotrophic factor (BDNF) between pre and post     treatment for patients with depression with either ECT or TMS.   "
212169|NCT00630136|"     The purpose of this study is to evaluate the effectiveness of the consent process currently     used for outpatient endoscopy procedures at our hospital. Results from this study will be     used to assist in making improvements in the way we communicate with parents, thereby     enhancing the ability to provide informed consents.   "
212170|NCT00630149|"     This is a pilot phase II study of locally advanced or metastatic nasopharyngeal carcinoma     (NPC) with the single drug Alimta. The objective of this study is to assess efficacy and     safety profiles of Alimta as 2nd line treatment for patients with advanced NPC.   "
212189|NCT00630396|"     The primary aim of this study is to find out which of 4 different doses of minocycline are     safe and well tolerated so that we will know the optimal dose to test in future patients.   "
212171|NCT00630162|"     In this two-year study, we will target two high risk groups, including MSM of HIV-infected     and those of non-HIV-infected. We will avail the serodiagnosis to detect the potential amebic     carriers in both groups; and use microscopy to detect protozoas other than amebiasis.     Meanwhile we will also survey the patients' status of sexual transmitted diseases (STD). For     the amebic carriers, we will apply specific antigen and molecular biologic method to follow     up the duration of the persistence of fecal amebas. We try to clarify the dynamic change of     amebic carriage.   "
212172|NCT00630175|"     The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release)     12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with     primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings     and patient sleep questionnaires.      The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR     12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.   "
212173|NCT00630188|"     The purpose of this study is to determine whether an intervention designed to help men share     decisions about prostate cancer screening with their physician results in better decision     making, more shared decisions, and changes in intended and actual screening rates.   "
212174|NCT00630201|"     Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral     tablets, patients experience withdrawal and cravings when the variable BPN levels in the     blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin     that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study     will test the safety and efficacy of Probuphine in the treatment of patient with opioid     dependence. Patients who have completed 24 weeks of treatment in the Randomized,     Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid     Dependence, will be re-treated with Probuphine over an additional 24 weeks.   "
212175|NCT00630214|"     the increased risk of hypocalcemia following total thyroidectomy plus central neck dissection     can be minimized by routine administration of oral calcium and vitamin D supplements during     the early postoperative period.   "
212176|NCT00630227|"     The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in     patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially     screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also     eligible for participation.   "
212309|NCT00631995|"     This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus     Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.      Primary Objectives: Safety and Immunogenicity:      To describe the safety and immunogenicity profiles of:        -  A single dose of each formulation of TetraMen-T vaccine        -  A single dose of NeisVac-C® vaccine.   "
212177|NCT00630240|"     Hepatocellular carcinoma (HCC) is the most common malignant tumor of the liver. Transcatheter     arterial chemoembolization (TACE) is the traditional method for the palliative management of     patients with HCC. Few previous studies had demonstrated that the serum level of anticancer     drug from patients treated by TACE was similar to those treated by systemic chemotherapy. The     defense ability of the patient treated by TACE may thus be influenced by the leakage of     anticancer drug to the systemic circulation. Since more than 80% patients with HCC also have     liver cirrhosis, the toxicity for those anticancer drugs with hepatic transformation will be     increased caused by the cirrhotic liver. The severity of pancytopenia in cirrhosis will be     exacerbated by the effect of bone marrow suppression caused by anticancer drugs. Patients are     at high risk for infection and hemorrhage. Therefore, it is of clinical importance to prevent     or decrease the leakage of anticancer drugs to systemic circulation in patients treated by     TACE. The procedures of TACE performed by previous studies were not constant and the     distributions of tumor vessels were not evaluated in detail. The possible risk factors for     the leakage of anticancer drug have not been investigated. This project will collect 60     patients with HCC including 30 patients with hepatitis B and 30 patients with hepatitis C.     The blood levels of anticancer drugs (epirubicin, mitomycin C and cisplatin) will be     determined within one hour and at the third day after TACE.   "
212178|NCT00630253|"     RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, before a donor stem     cell transplant helps to remove the patient's cells to allow for the transplant cells to take     and grow. It also helps stop the patient's immune system from rejecting the donor's stem     cells. When the healthy stem cells from a donor are infused into the patient, they may help     the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Sometimes the transplanted cells can make an immune response against the body's normal cells.     Giving antithymocyte globulin and removing the T cells from the donor cells before transplant     and giving cyclosporine before and after transplant may stop this from happening.      PURPOSE: This phase I/II trial is studying the side effects of cyclophosphamide, fludarabine,     and antithymocyte globulin followed by donor stem cell transplant and to see how well it     works in treating patients with Fanconi anemia.   "
212179|NCT00630266|"     The purpose of this study to evaluate patients when they have an Acorn CorCapTM Cardiac     Support Device (CSD) placed around their heart for the treatment of heart failure at the same     time as their mitral valve surgery.      The CorCapTM CSD is intended to support the heart, potentially preventing further dilation     that is associated with progressive heart failure, thereby potentially preserving or     improving heart function.   "
212180|NCT00630279|"     This study is to estimate the efficacy of a number of doses in patients with pancreatic     insufficiency   "
212181|NCT00630292|"     This is a pilot study designed to explore the feasibility of non-invasively diagnosing the     presence of cancer in the breast using non-invasive magnetic resonance imaging (MRI) methods     and an analysis of vessel shape defined from these magnetic resonance images.   "
212182|NCT00630305|"     Evaluate the short-term corneal response of oxygen deprivation when using toric contact     lenses. The response will be noted by endothelial bleb formation in both open eye and closed     eye state.   "
212183|NCT00630318|"     Preliminary imaging study to test for future use of this MRI-imaging for evaluating     anti-angiogenesis treatment.   "
212184|NCT00630331|"     The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of     both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in     healthy adults 18 to 49 years of age.   "
212185|NCT00630344|"     The goal of this clinical trial is to learn if the study drug RAD001 in combination with     Bicalutamide can slow the growth of prostate cancer. The safety of RAD001 given together with     Bicalutamide will also be studied. RAD001 has been shown to kill prostate cancer cells. In     addition, several hundred kidney and heart transplant patients have been treated with the     same main ingredient as in RAD001 for many years.   "
212192|NCT00630435|"     The purpose of this trial is to determine the equivalence of 3 new formulations of a     Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed     dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women.     Each subject will participate in the study for approximately 14 weeks, including a screening     evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with     at least a 21-day washout interval between each dose administration.   "
212193|NCT00630448|"     Von Willebrand disease is an inherited bleeding disorder that impacts the blood's ability to     clot properly. Von Willebrand disease is cause by the lack or not working substance in the     blood known as Von Willebrand factor.      Current therapy for Von Willebrand disease includes desmopressin acetate (DDAVP) and /or     VWF/FVIII concentrates. Patients with severe Von Willebrand disease face a lifetime of weekly     treatments and mounting medical bills. Gene therapy could help these patients improve their     quality of life by providing the missing factors necessary for the blood's ability to clot     properly.      The gene transfer options being studied include naked DNA, viral gene transfer vectors     encoding Von Willebrand factor transgenes, and ex vivo cell therapy. The latter involves     transplantation of the patient's own cells modified with a corrected copy of the defective     gene. Human blood outgrowth endothelial cells (BOEC) display all the properties needed for     successful ex vivo cell therapy. We plan to obtain blood samples from normal research     subjects and patients with Von Willebrand Disease in order to isolate blood outgrowth     endothelial cells (BOEC) from peripheral blood, and develop a ex vivo gene therapy for Von     Willebrand Disease.   "
212220|NCT00630812|"     The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with     inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated     improvements in lung function, mucociliary clearance, changes in physical properties of     mucus, 24 hour sputum weight and quality of life. The results of this study are to further     investigate and confirm these findings in addition to examine the effect on antibiotic use     and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects     compared to a control treatment. An open label phase of 26 weeks duration will follow the     blinded 26 week phase. During the open label phase all subjects will receive active     treatment.   "
212221|NCT00630825|"     To study once weekly injections of LY2189265 compared to placebo on blood glucose by     measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight     Type 2 Diabetes Mellitus participants.   "
212194|NCT00630461|"     Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of     different workplaces, and is even found in homes. The endotoxin used for this study is     obtained from the National Institutes of Health, and is called Clinical Center Reference     Endotoxin, or CCRE. The purpose of this Phase 1 research study is to identify a dose of     inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other     problems), but causes changes in your sputum cell samples that the scientists can measure.     Phase 1 research studies like this one are not intended to be a treatment, but are a     scientific investigation. Eventually, with these types of studies we will be able to examine     why some people are more sensitive to endotoxin. Scientists at other universities have found     that while most people do not have a considerable lung response to endotoxin at doses as high     as 60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our     study is designed to identify if using a dose of 20,000 EU causes changes in the lung cells     but does not cause symptoms in our study subjects. In our previous studies in our lab, using     an endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with     asthma with no major problems, and we have used 10,000 EUs of CCRE in subjects with allergies     and asthma without problems. We have used 20,000 EUs of CCRE in healthy individuals with no     major problems.   "
212195|NCT00630474|"     Whether impaired nasal breathing contributes to sleep related breathing disturbances has not     been known. Therefore, the purpose of the study is to compare the effect of xylometazoline, a     drug that decongests the nasal mucosa when applied locally, with placebo in terms of sleep     and nocturnal breathing and daytime performance.   "
212196|NCT00630487|"     The study will investigate the effect on growth hormone replacement in patients with isolated     growth hormone deficiency on body composition, especially visceral fat mass.   "
212197|NCT00630500|"     A 24-week placebo-controlled parallel group multicentre trial to study the safety and     efficacy of memantine in patients with dementia associated with Parkinson's disease and     dementia with Lewy bodies. It is hypothesized that memantine will be safe and well tolerated,     and more effective than placebo.   "
212198|NCT00630513|"     The aim of the study was to compare the activity (efficacy and safety) of Ertapenem     administered according to a short treatment for three days versus a short treatment for three     days with AS in patients with an community acquired IAI of mild to moderate severity.   "
212199|NCT00630539|"     The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5     mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum     effective dose below the lowest dose of 30 mg tested earlier in Phase II.   "
212200|NCT00630552|"     This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine     as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an     open-label, dose-escalation phase 1b segment to determine the safety, tolerability and     maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of     the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to     estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo     in combination with gemcitabine. The phase 2 segment that will commence after dose selection     in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in     combination with gemcitabine.   "
212201|NCT00630565|"     RATIONALE: Giving chemotherapy and colony-stimulating factors, such as G-CSF, may increase     the number of stem cells in the blood. The stem cells are collected from the patient's blood     and stored. Chemotherapy or radiation therapy is given to prepare the bone marrow for the     stem cell transplant. The stem cells are then returned to the patient to replace the     blood-forming cells that were destroyed by the chemotherapy and radiation therapy.      PURPOSE: This clinical trial is studying how well an autologous stem cell transplant works in     treating patients with acute myeloid leukemia.   "
212215|NCT00630747|"     Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year     Phase 2/Phase 3 registration study. The primary objective of this extension study was to     collect long-term safety and clinical outcome data in Mucopolysaccharidosis II (MPS II), also     known as Hunter Syndrome, from the Phase 2/Phase 3 Study TKT024. All patients enrolling into     this study received weekly active treatment with idursulfase, the primary dosing regimen     investigated in Study TKT024.      Hunter Syndrome is an X-linked recessive lysosomal storage disease caused by a deficiency of     iduronate-2-sulfatase, an enzyme required to catabolize glycosaminoglycans (GAGS) in cells.     As a result, GAGs accumulate in the lysosomes leading to cellular engorgement, organomegaly,     tissue destruction, and organ system dysfunction. Hunter Syndrome is a rare disease with an     estimated incidence of 1 in 162,000 live births.   "
235938|NCT00942786|"     The investigators hypothesize that the level of perioperative natriuretic peptides is     associated with in-hospital and long term major adverse cardiac events.   "
212202|NCT00630578|"     This proposal seeks to increase the effectiveness of an existing treatment strategy,     cognitive processing therapy (CPT), for the remediation of Posttraumatic Stress Disorder     among crime victims by varying the duration and content of the intervention in accordance     with participants' needs. A secondary goal is to identify predictors of duration of treatment     necessary to achieve good end state functioning, including individual and trauma variables,     cognitive and emotional variables, and Axis II pathology. Finally, by including a sample of     male participants, the generalizability of CPT will be tested. It is anticipated that these     modifications will speed the dissemination of CPT to community practice thus benefiting more     trauma victims. Fifty subjects will be randomly assigned to either the modified CPT condition     or to a symptom-monitoring, minimal attention condition designed to control for the effects     of the daily monitoring and the passage of time. Utilizing a semicrossover design, the     control condition will be crossed over to the active treatment, allowing for a replication     within the study. The entire treated sample (N = 50) will be compared to a sample (N = 50)     receiving strict 12-session protocol-driven CPT through the course of a recent study     conducted at the same site using the same primary outcome measures. Conducting the proposed     study will have important implications on advancing the ecological validity and effectiveness     of applied research on PTSD.   "
212222|NCT00630838|"     Prospective, randomized, controlled trial to test if post-operative administration of     probiotics in HD patients will lead to a reduction in the occurrence of HAEC.   "
212203|NCT00630591|"     Primary Aim:      -To explore the feasibility and acceptability of two distinctly different tailored,     home-based diet and exercise interventions (one that relies on a partner-assisted, team-based     approach that emphasizes the mother-daughter bond and one that is delivered to each     independently) vs. standardized materials (attention control). This aim will be accomplished     by assessing overall accrual, and by quantifying retention and adverse events in each study     arm.      The study will be deemed feasible if it achieves the following criteria:        1. Accrual of 67 mother-daughter dyads into the intervention is accomplished within a          1-year period;        2. An attrition rate of less than 20% is achieved; and        3. The frequency of total adverse events is not significantly higher in either of the          intervention arms (as compared to the attention control arm), and there is no more than          one reported serious adverse event that is directly attributable to either of the          interventions.      Detailed process data also will be collected on each intervention, i.e., use and perceived     helpfulness of materials in promoting behavior change, frequency and quality of interaction     between members of the mother-daughter dyad, feedback regarding intervention materials, etc.      Secondary Aim:      -To explore potential effects (and variation) noted among each of the three intervention arms     from baseline to 6 and 12- month follow-up on the following endpoints: BMI, energy intake and     nutrient density of the diet, exercise [min/week and metabolic equivalents (METs)],     self-efficacy to adhere to an energy restricted, plant-based, low saturated fat diet and     increased exercise, blood pressure, health-related quality of life (HRQOL), social support     (in general and as specifically related to healthful dietary and exercise behavior), and     characteristics of the mother-daughter bond (e.g., strength).      Secondary Aim:      -To explore potential mediators and moderators of healthful dietary and exercise behaviors,     such as the strength of the mother-daughter bond, geographic proximity of mothers and     daughters, self-efficacy for lifestyle change, etc.   "
212204|NCT00630604|"     The purpose of this study is to investigate the feasibility of using quantitative     ultrasonography (US) evaluation to determine the severity of osteoarthritic femoral condyle     cartilage erosion.   "
212205|NCT00630617|"     To develop and evaluate a culturally appropriate childhood obesity prevention program     targeting primary care-givers of third grade students. The cognitive-behavioral lifestyle     intervention consisted of eight, 90-minute sessions at the elementary schools.      Primary outcome: body mass index of third graders and their primary care-givers Primary     objective: To engage primary care-givers of third grand children in identifying and creating     health promoting culturally appropriate environments for young children.   "
212206|NCT00630630|"     The relationship between hormone cycling/fluctuations and the occurrence of seizures in women     has received considerable discussion in the medical literature. This study investigated the     efficacy and tolerability of LEV treatment for subjects with catamenial exacerbation of     partial onset seizures.   "
212207|NCT00630643|"     The purpose of the study is to assess the safety and tolerability of daily intravenous     NI-0401 treatment, compared to matching placebo. And to assess the ability of NI-0401 to     modulate the CD3 complex on T-cells.   "
212208|NCT00630656|"     Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an     addition to the standard care of severe sepsis.   "
212209|NCT00630669|"     The purpose of this study is to determine which treatment, band ligation (placing rubber     bands around the hemorrhoids) or BICAP electrocoagulation (using electricity to cauterize) is     safer and more effective endoscopic treatment for bleeding internal hemorrhoids.   "
212210|NCT00630682|"     The purpose of this study is to assess the safety and effectiveness dextroamphetamine to help     methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible     participants will attend research visits twice per week, and will receive individual     counseling sessions once per week for all 9 weeks. 50% of the participants will receive the     active medication while the other 50% will receive the placebo (sugar pill). Neither the     participant or the study team will know if the participant is receiving the placebo or active     drug.   "
212211|NCT00630695|"     Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo.     Evaluation of the lymphorrhea in the 2 arms of the study   "
212212|NCT00630708|"     The primary aim of the present study is to assess the safety of combined treatment of     benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced     renal insufficiency.   "
212213|NCT00630721|"     Determine the in-vivo mechanism of action of INF-B-1b as it's mechanisms of action are not     completely understood. We propose that high dose exogenous recombinant IFN-B-1b induces     tolerizing effect on DC-dependent T-cell differentiation in patients with MS by inducing the     expression of SOCS3 in DCs.   "
212214|NCT00630734|"     Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to     treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food     and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given     with pravastatin, they can increase the blood levels of pravastatin. The degree of this     interaction varies from person to person. The way that darunavir and ritonavir interact with     pravastatin may be affected by a person's genetic make-up. Genetic factors (or DNA) are those     that people are born with and that make each person unique. Genetic differences are the     reason why one person's body traits such as height and hair color are different from another     person's body traits. Genetic differences can also affect the way a medication works in the     body or the way two medications interact in the body. The purpose of this clinical study is     to determine if a person's genetic make-up affects the way darunavir and ritonavir interact     with pravastatin in the body.   "
238808|NCT00981903|"     In this study the investigators will determine the safety and effectiveness of Tinzaparin in     preventing blood clots for up to 12 months of treatment.   "
212217|NCT00630773|"     This prospective, pilot observational study will be performed in the Emergency Department     (ED), Pediatric Intensive Care Unit (PICU), Operating Room (OR) and regular inpatient care     area (RIPCA) settings at the Children's Hospital of Philadelphia. The differences in trained     pediatric health care provider placement of the compression sensor and their assessment of     the suitability / willingness to use the current or size modified sensor will be assessed.   "
212218|NCT00630786|"     This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2)     study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal     Cancer.   "
212219|NCT00630799|"     This is a multi-center, open-label study of 2 doses of leuprolide acetate 17 mg depot,     administered three months apart, in subjects with prostate cancer who might benefit from     medical androgen deprivation therapy   "
212223|NCT00630851|"     The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home     patients with severe Alzheimer's disease.   "
212310|NCT00632008|"     The purpose of this study is to determine whether the application of soluble beta-glucan     (SBG) onto diabetic foot ulcers improves the healing of the ulcers.   "
212224|NCT00630864|"     This is an open-label, multicenter, international study designed to determine TTR     stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical     outcomes in patients with non-V30M TTR amyloidosis.      Strong pre-clinical and clinical evidence support a daily dose of 20 mg of Fx-1006A to be the     optimum dose to achieve stabilization of tetrameric TTR in ATTR-PN patients. Since disease     presentation is similar between V30M and non-V30M TTR mutations associated with ATTR-PN and     Fx-1006A has been shown to stabilize wild-type and V30M TTR in vitro and ex vivo, the present     study is being conducted to determine the effects of Fx-1006A on TTR stabilization in ATTR-PN     patients with TTR mutations other than V30M. Safety and exploratory efficacy of Fx-1006A     administered once daily for 12 months will also be evaluated in this patient population.      This is an open-label, multicenter, international study designed to determine TTR     stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical     outcomes in patients with non-V30M TTR amyloidosis. The study will be conducted in two parts.     Part 1 will include a six-week dosing period during which all enrolled patients will receive     oral Fx-1006A 20 mg soft gelatin capsules once daily for six weeks. At Week 6, blood samples     will be collected from each patient to determine TTR stabilization. Patients who complete the     Week 6 visit will continue receiving daily oral Fx-1006A 20 mg for up to a total of 12 months     during Part 2 of this study. If it is determined that a patient is not stabilized at Week 6,     the patient will be discontinued from the study.      During Part 2, clinical outcomes will be measured at Months 6 and 12, based on NIS, Norfolk     QOL-DN, mBMI, NCS, HRDB, SF-36, Karnofsky score, and echocardiography; NT-pro-BNP and     troponin I levels will be measured at Baseline, Weeks 2 and 6, and Months 3, 6, and 12.      Pharmacokinetic measurements will be made using samples collected at Baseline, Week 6, and     Months 6 and 12.      Safety and tolerability will be assessed throughout the study based on vital signs, physical     examinations, ECG, echocardiography, 24-hour Holter monitoring, clinical laboratory tests     (hematology, serum chemistry, and urinalysis), and monitoring adverse events and concomitant     medication use.      Day 1 will be defined as administration of the first dose of study drug. Clinic Visits will     be conducted during Screening (Days -30 to -1) and at Baseline (Day 0), and Week 2, and Week     6, and Months 3, 6, and 12 (± 2 weeks of the scheduled date for post-Baseline visits).     Monthly telephone contacts (+ 1 week of the scheduled date) will be made during months in     which no investigative site visits are scheduled (Months 4, 5, 7, 8, 9, 10, and 11) for     assessment of adverse events and concomitant medications. A final telephone contact to assess     adverse events and concomitant medication usage will be made 30 days after the last dose of     study drug.      Patients who discontinue from the study at any time following enrollment will have a final     visit performed, including all safety assessments, at the time of discontinuation. Any     patient discontinuing after the Month 6 visit will also have all exploratory assessments     performed.   "
212225|NCT00630877|"     The primary purpose of this study was to evaluate the psychometric characteristics     (reliability, validity, and responsiveness) of a Flushing ASsessment Tool (FAST) in subjects     receiving niacin extended-release (NER) plus aspirin (ASA) daily for 6 weeks.      The FAST is a questionnaire that was developed to provide a detailed assessment of flushing     symptoms and their impact in patients receiving niacin therapy. The effect of aspirin on     flushing symptoms, as measured by the FAST, was also evaluated.   "
212226|NCT00630890|"     The purpose of this study is to test the safety of giving external beam radiation, followed     by a Cyberknife radiosurgery boost at different dose levels, together with a chemotherapy     drug called capecitabine. The dose of Cyberknife radiosurgery boost will be made higher     slowly in this protocol. Patients with hilar cholangiocarcinoma (Klatskin tumor), which is     not amenable for surgical removal, are eligible.      The hypothesis is that highly focused high dose radiation delivered using Cyberknife in     conjunction with traditional radiation and chemotherapy can improve outcome in this patient     population.   "
212227|NCT00630903|"     The purpose of this study is to determine if combination of PUVA with interferon alpha is     better than PUVA alone to treat mycosis fungoides stage Ia Ib or IIa.   "
212228|NCT00630916|"     This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart     Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve     prosthesis.   "
212229|NCT00630929|"     To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with     osteoarthritis (OA) of the knee.   "
212230|NCT00630942|"     The purpose of the study is to see how safe and effective minocycline is in the treatment of     Primary Sclerosing Cholangitis (PSC).   "
212231|NCT00630955|"     The purpose of this study is to evaluate the effects of the study medication, memantine     (placebo, 20 mg or 40 mg/day) on alcohol drinking behavior in a laboratory setting in which     participants are given an initial drink of alcohol followed by the choice to drink up to 12     more drinks over a three-hour period. We hypothesize that memantine will reduce craving and     number of drinks consumed prior to and after exposure to the initial drink of alcohol and     during the three hour drinking period. We will also evaluate the influence of family history     of alcoholism on the efficacy of memantine in reducing alcohol drinking behavior.   "
212232|NCT00630968|"     The purposes of the study were to obtain further information about the optimal dose and the     efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and     tolerability profiles of the drug observed during clinical development.   "
212233|NCT00630981|"     The purpose of this observational study is to measure the efficacy of a specific combined     treatment (psychotherapy and pharmacotherapy) on patients with dissociative disorders, in     terms of patients with a favorable outcome by means of the Dissociative Experiences Scale     (DES).   "
212234|NCT00630994|"     RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying the side effects and how well low-dose decitabine     works in treating patients with symptomatic myelofibrosis.   "
212235|NCT00631007|"     This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with     pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women     (of non-childbearing potential or using dual barrier methods of contraception) between 30 and     75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or     sulfonylurea plus metformin combination therapy.   "
212236|NCT00631020|"     Reducing tobacco use by adolescents is a national health priority. In recent polls, most     adolescent smokers reported having tried unsuccessfully to quit. Smoking cessation treatment     during adolescence has the potential to interrupt the progression to nicotine dependence,     which is attended by a wide range of negative health consequences. Given the need for     effective smoking cessation programs aimed at youth, scientifically rigorous research is     warranted to reduce adolescent smoking. This project will address gaps in the scientific     treatment literature. The goal of this project is to develop a tailored, practical, and     efficacious smoking cessation intervention. Combined with other efforts in the field, this     work can provide an initial guide to an evidence-based treatment for smoking cessation in     youth.      In keeping with developments in other fields of medicine, we believe that further advances in     smoking cessation will move towards a goal of personalized treatment. Such an individualized     approach for adolescent smoking cessation will be informed by further investigation of the     relationships between outcomes in this trial. To serve these goals, we propose the following     program:      Youths who smoke regularly will receive a 6 week intervention using cognitive-behavioral     motivational enhancement (CBME) supplemented by nicotine replacement therapy (NRT), if youth     and parents desire this option. Furthermore, youth has to smoke more than 5 cigarettes a day     in order to qualify for nicotine replacement therapy. This approach is consistent with     treatment guidelines for smoking cessation (Fiore 2000).      Compared with participants who fail to achieve smoking cessation, those who successfully     achieve smoking abstinence during intervention, will have lower baseline rates of comorbid     ADHD, lower depressive symptom scores, enhanced readiness to quit, more negative attitudes     towards smoking, fewer friends who smoke, and fewer family members who smoke. The     investigators predict that the intervention will help youth to quit smoking and will examine     predictions of successful quitting.   "
212237|NCT00631033|"     The purpose of this study is to determine whether there is an additive effect of metformine     on the weight reduction of obese hyperinsulinemic men who are treated with diazoxide.   "
212239|NCT00631059|"     The objective of this protocol is to collect leukemia cell specimens from adults (18 years of     age) diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time     of first relapse. These specimens, in conjunction with a de-identified data set, will be     utilized prospectively to determine potential chemotherapy resistance in this patient     population.      The specific aims of this study are as follows:      To collect peripheral blood specimens from patients diagnosed with acute leukemia at time of     initial diagnosis and, if applicable, at time of first relapse To evaluate the leukemia cells     in the blood specimens for chemotherapy resistance utilizing the Hem(A)+ technology      To develop a body of evidence from acute leukemia patients that demonstrates the     applicability of the Hem(A)+ assay to determine the following:      Predict responders and non-responders to common chemotherapeutic agents Track treatment     results and comparison to prediction results from the assay Identify optimal chemotherapy     doses for each patient Identify the most efficacious pharmaceutical agent combinations   "
212240|NCT00631072|"     The purpose of this research study is to determine whether we can purify and grow a     population of cells from the participants blood (iNKT cells) and then safely give them back     to the participant in increased numbers, and whether these cells will then stimulate the     bodies own immune response against the cancer. These iNKT cells have been used in laboratory     studies and information from these and other research studies suggest that increasing the     number of these cells in the blood can stimulate the immune response against tumors.   "
212241|NCT00631085|"     The purpose of this research study is to learn whether high dose vitamin E (gamma tocopherol)     will affect the way your body responds to an acute inflammation in your lungs. Vitamin E is     found in soybean and vegetable oils as well as many plant seeds. Gamma tocopherol (gT), a     component of vitamin E, composes 70-80% of Vitamin E in the U.S. diet. Alpha tocopherol (aT),     another large component of vitamin E, makes up less than 10% of vitamin E in the U.S. diet,     but is the major form in blood and tissue. It is also the major form of Vitamin E in     over-the-counter supplements. However, gT has anti-inflammatory properties which are not     present in aT. Preliminary data suggests that gT protects from ozone-induced exacerbation in     animal studies, and previous studies have shown levels of gT are inversely associated with     heart disease.      We will ask you to undergo a challenge with endotoxin, which is a bacterial component of air     pollution. From other studies we have done, we know that if you inhale 20,000 EUs (endotoxin     units) we will see an increase in the number of neutrophils (a type of white blood cell that     your body produces to fight infection) in your lung cells without causing you to have     flu-like symptoms. We will investigate if there is a change in your lung inflammatory cells     after the endotoxin challenge when you take the gT versus when you take a placebo.   "
212242|NCT00631098|"     International CPR guidelines recommend the cannulation of a peripheral vein (antecubital or     external jugular) during resuscitation. One reason for preferring the external jugular vein     over more peripheral veins is the faster circulation time of drugs during CPR. The     differences in circulation time may be over 90 seconds between peripheral and central     (internal jugular) veins. However, cannulation of the external jugular vein may be more     difficult and time consuming than cannulating cubital veins. There are no studies on the     success rate, cannulation time and reliability of venous access comparing central and     peripheral cannulation sites.      We hypothesized that cannulation of the external jugular vein (by paramedics and is a     demanding procedure in an emergency situation and should not be recommended during     resuscitation.      The aims of this study are to compare the feasibility of cannulating the external jugular     vein compared to the cubital vein in terms of attempts, cannulation time and reliability of     venous access.   "
212243|NCT00631111|"     Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in     the treatment of pain following third molar extraction in comparison to single doses of     placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.   "
212244|NCT00631124|"     Investigation of a new pill containing an estrogen and a progestin in order to monitor the     inhibition of the ovulation in young healthy females over 3 treatment cycles   "
212245|NCT00631137|"     RATIONALE: Testosterone gel may be effective in preventing or lessening muscle weakness     caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade     glioma.      PURPOSE: This randomized clinical trial is studying how well testosterone gel works in     preventing weakness caused by steroid therapy in men receiving glucocorticoids for newly     diagnosed high-grade glioma.   "
212246|NCT00631150|"     Patients in community-based practices correspond to the 25% of patients who need a first     add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic     use trial in which the population corresponds more closely to that seen in daily clinical     practice.   "
212247|NCT00631163|"     The overall purpose of this trial is to further evaluate the efficacy and safety of     deferasirox, dosed initially according to the transfusional iron intake, in patients with     transfusion dependant anemia related to disorders other than β-thalassemia and sickle cell     disease.      During the study, the dose will be adjusted based on serum Ferritin.The overall purpose of     the extension is to allow further treatment of patients who have already completed the core     study, and to enable collection of long term efficacy and safety data. Patients will continue     to receive Deferasirox at the dose they received at the end of the core study.   "
212248|NCT00631176|"     This is a prospective interventional study to test the hypothesis that just-in-time training     for pediatric airway management may improve patient safety and operational performance of     orotracheal intubation and decreases intubation associated events in pediatric residents in     the PICU. To test the hypothesis that high fidelity simulation may enhance the training     efficacy and patient safety in simulation settings.   "
212249|NCT00631189|"     The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an     hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and     Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation     after 8 weeks of treatment.   "
212311|NCT00622583|"     To determine patient reported long-term outcomes, and post-implantation clinical     characteristics related to the use of mesh products in 3,500 patients minimum.   "
212312|NCT00622596|"     The purpose of this study was to expand access to buprenorphine using a mobile health care     system among marginalized populations with or at high risk for HIV and observe longitudinal     effects of treatment.   "
212250|NCT00631202|"     Friedreich's ataxia is a rare genetic disorder characterized by severe neurological     disability and cardiomyopathy. Friedreich's ataxia is the consequence of frataxin deficiency.     Although several drugs have been proposed, there is no available treatment. It was recently     demonstrated that erythropoietin can increase the intracellular levels of frataxin in an     in-vitro model.      The present project is aimed at testing the possible therapeutic approach of erythropoietin,     which is an already available and commercialized drug. The investigators will perform both     in-vitro and in-vivo tests, in order to asses its efficacy and safety in patients. The     results will be useful to plan further clinical trials.   "
212251|NCT00631215|"     HYPOTHESIS        1. Hyperbaric Oxygenation Therapy will be safe to use with neurotypical adults and          children.        2. Hyperbaric Oxygenation Therapy will have a statistically significant positive effect on          measures of cognitive function in neurotypical adults and children.        3. The improvement in cognitive function will correlate positively with the number of          Hyperbaric Oxygenation Therapy sessions.        4. Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at          follow-up, post 40 treatment sessions.   "
212252|NCT00631228|"     XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study     to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real     world settings.   "
212253|NCT00631241|"     The goal of this clinical research study is to find out if the parametrial nodes are     sentinel nodes (the lymph nodes believed to be the greatest risk for the spread of cancer)     and if intraoperative lymphatic mapping can identify sentinel lymph nodes in the     parametrium (the tissue that is on either side of the cervix). Identifying these lymph nodes     may help to predict the status of the remaining lymph nodes in the pelvis. This research will     also determine if India Ink is safe to use with the blue dye and radioactive tracer and if it     improves the process of identifying the sentinel nodes.   "
212254|NCT00631254|"     Cysteinyl leukotrienes (CysLTs) play an important role in asthma. CysLTs exert most of their     bronchoconstrictive and pro-inflammatory effects through activation of the CysLT1-r. As     allergic rhinitis appears to be a predisposing factor in the development of asthma and as     CysLT-receptors seem to be implicated in the first steps of asthma manifestations, we think     it would be of interest to determine if the CysLT1-r is a key mediator in the progression     from allergic rhinitis to asthma. We believe it would be interesting to study the expression     of the CysLT1-r      Our goal is to assess baseline, as well as variations following allergen bronchoprovocations,     in the expression of the CysLT1-r in mild asthmatic subjects compared with non asthmatic     subjects with allergic rhinitis.      Our hypothesis is that there will be a higher baseline expression of the CysLT1-r in     asthmatic subjects compared with allergic rhinitis subjects and that allergen     bronchoprovocations will induce an increase in the expression of the CysLT1-r in both groups.   "
212255|NCT00631267|"     Rationale:      Many different closed techniques are used to reduce a dorsally dislocated distal radius     fracture (Colles' fracture). One trial to compare two main techniques (finger-trap traction     and manual manipulation) did not find significant difference in radiological and clinical     outcome (Earnshaw 2002). This trial aims to investigate patient and medical satisfaction     between both techniques      Objective:      To demonstrate patient satisfaction (pain, duration, general) and medical satisfaction     (difficulty of reposition). It is suggested that finger-trap traction causes less pain for     patients and is more easy than manual manipulation but have the same radiological and     clinical outcome.      Study design:      Randomised controlled intervention study      Study population:      300 Patients with newly diagnosed closed distal radius fractures with dorsal angulation     (Colles' fracture) older than 16years coming to the Emergency Medical Department.      Intervention:      One group is put in finger-trap traction (digitus 1-3) for 10minutes with 4-5kg of ballast on     their upper arm followed by reduction by dorsal pressure. The other group is manually reduced     according to Charnley with traction and hooking over of the fracture elements.      Main study parameters/endpoints:      Visual analogue scale of patient and medical satisfaction, percentage of successful primary     reductions. Nature and extent of the burden and risks associated with participation, benefit     and group relatedness: Apart for the regular follow-up of patients with distal radius     fractures,one extra out-patient visit is necessary to assess functional outcome after three     months.Finger-trap traction has a (theoretical) risk of causing traumatic damage to ligaments     of the fingers, but this risk is in our opinion not higher than in the manual manipulation.     It is expected that the finger-trap traction group is more satisfied because this technique     seems less traumatic than but as successful as the manual manipulation group.   "
212256|NCT00631280|"     The purpose of the study is to determine whether active parent involvement in deliberation     and choice improves subsequent medication persistence for their child with ADHD.   "
212257|NCT00631293|"     Study of the effect of lactisole on glucose uptake   "
212258|NCT00631306|"     This study is being done to determine if the use of double strength cranberry juice in daily     diet will improve endothelial function.   "
212260|NCT00631332|"     The Women's Health Initiative Study of Cognitive Aging (WHISCA) is a two-armed, randomized,     placebo controlled, clinical trial designed to assess the efficacy of postmenopausal hormone     therapy (HT) on age related changes in specific cognitive functions.   "
212261|NCT00631345|"     The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized     trial designed to test the effectiveness of a lay-health counselor led community-based     diabetes prevention program in reducing blood glucose in people at risk for developing     diabetes mellitus.   "
212262|NCT00631358|"     The primary purpose of this study is to quantify the change in expression of biomarkers on     the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.   "
212263|NCT00631371|"     Primary objective: Comparison of independently assessed progression free survival (PFS) in     subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab +     Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response     rate (independently assessed), and overall survival.   "
212264|NCT00631384|"     The objective of this research is to evaluate the effectiveness of couples Voluntary     Counseling and Testing for HIV (CVCT) compared to individual VCT (IVCT) in preventing MTCT,     and in increasing preventive behaviors and minimizing spousal abuse among HIV positive women.     We hypothesize that offering CVCT will not decrease uptake of VCT among women. This research     will be carried out in 3 antenatal clinics in Dar es Salaam, Tanzania.   "
212265|NCT00631397|"     The study is to measure how dense or solid the infant's bones are using a new ultrasound     machine and how that density changes over time.   "
212266|NCT00631410|"     To assess the safety and tolerability of sunitinib when administered in combination with     modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line     treatment setting.   "
212338|NCT00622934|"     The purpose of this study is to determine whether Erythropoietin decrease stress responses     and inflammation in trauma patient.   "
212268|NCT00631436|"     Brain injury from explosive blast is a prominent feature of contemporary combat. Although     protective armor and effective acute medical intervention allows soldiers to survive blast     events, a growing number of veterans will have disability stemming from blast-related neural     damage. Soldiers also return from combat with psychological disabilities caused by traumatic     war events. The clinical presentation of individuals with blast-related neural damage and     post-traumatic psychopathology are markedly similar and thus a clear description of the     direct consequences of explosive blast is complicated by the emotional and cognitive sequelae     of psychological trauma. We will use sophisticated measures of neural function and structure     to characterize brain injury from explosive blasts in a sample of Operation Iraqi Freedom     (OIF) National Guard soldiers who returned from deployment in the fall of 2007. Survey data     gathered near the end of deployment indicated that over 50% of the brigade had been exposed     to direct physical effects of explosive blasts. To fully characterize the effects of blast on     the brain and differentiate them from post-traumatic stress disorder, we will contrast groups     of soldiers exposed to blast and with groups experiencing post-traumatic stress disorder.     This investigation will improve the characterization of blast-related traumatic brain injury,     describe the essential features of the condition in terms of neural function and structure to     inform diagnosis, and characterize mechanisms of recovery after blast-related neural injury     to allow the creation of interventions that return soldiers to maximum levels of functioning.   "
212269|NCT00631449|"     The purpose of this study is to determine whether treatment with Raltegravir further     decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially     improving immune response to antiretroviral therapy.   "
212270|NCT00631462|"     The purpose of this study is to evaluate the safety and tolerability of orally administered     TG101348 in patients with myelofibrosis.   "
212271|NCT00631475|"     This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed     protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability     of bosentan in patients with idiopathic pulmonary fibrosis (IPF).   "
212272|NCT00631488|"     This study will test the effectiveness and safety of treatment with MK-0893 in combination     with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.   "
212273|NCT00631501|"     Matrix metalloproteinases are involved in the pathogenesis of tendinopathy. Doxycycline, a     widely available pharmaceutical agent mostly used for its antibiotic properties, also     functions as an inhibitor of MMPs.      This study aims to investigate the effect of doxycycline treatment on lateral epicondylalgia     (tennis elbow). During three weeks, patients receive doxycycline tablets 100 mg twice daily,     or placebo. Main outcome variable is pain (VAS) at three weeks.      Serum and/or plasma levels of matrix metalloproteinases and tissue inhibitors of     metalloproteinases are measured.   "
212274|NCT00631514|"     NSAIDs may increase blood pressure and blunt the effects of many antihypertensives. Members     of these drug classes differ in their propensity to such an interaction.   "
212275|NCT00631527|"     The goal of this clinical research study is to learn the safety of adding 3 different     dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation     in patients with prostate cancer.   "
212276|NCT00631540|"     The purpose of the study is to evaluate the safety and effectiveness of the Formula     Balloon-Expandable Stent in treatment of renal artery stenosis.   "
212277|NCT00631553|"     The purpose of this study is to determine if contrast enhanced ultrasound (CEU) using     microbubbles, is useful in assessing changes in kidney blood flow.   "
212278|NCT00631566|"     This study will prospectively evaluate the prevalence and incidence (over a two year period)     of MRSA colonization and infection among HIV-infected military beneficiaries to determine     predictors for the development of MRSA colonization and infection. This study will also     investigate the utility of decolonization procedures for clearance of MRSA carriage and     prevention of MRSA infections. Finally, the molecular characteristics and the antimicrobial     sensitivities of isolates in this population will be determined.   "
212846|NCT00635739|"     This research study is looking at the effects of a whey protein nutritional supplement on     changes in muscle mass, strength and physical function in response to a 6 month program of     strength training exercise.   "
212279|NCT00631579|"     The primary objectives of the study are to evaluate the safety and the efficacy in patients     with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days     in two dosage groups.      Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to     assess anti-SR29142 antibody production in patients with malignant lymphoma and acute     leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the     results of efficacy and safety evaluations.   "
212280|NCT00631592|"     This is a repeat dose escalation study of GSK1349572 followed by a relative bioavailability     study comparing tablet and suspension formulations in healthy volunteers.   "
212281|NCT00631605|"     This study aims to investigate neuroendocrine, autonomic functioning, and energy metabolism     in patients with eating disorder and their relationships with psychopathology of eating     disorders (eating patterns, depression, and personality) in these patients.   "
212282|NCT00631618|"     The purpose of this study is to investigate whether an investigational drug called sunitinib     malate is safe and effective in treating metastatic melanoma in patients with KIT mutations.      KIT is a gene that codes for (contains the genetic code that the body uses to make) a     protein on the surface of cells in your body that is important in cell growth and cell     division. The KIT protein seems to play a role in abnormal cell growth seen in acute     leukemia, germ cell tumors, gastrointestinal stromal tumors (GIST), and certain melanomas.     Melanomas that arise on acral skin (palms, soles, nail beds), mucosal membranes, and     chronically sun damaged skin have recently been found to frequently contain mutations or     increased copy numbers of the KIT gene. Your tumor tissue has previously been tested and has     been found to contain abnormalities in the KIT gene.      Sunitinib malate is drug that has been shown to inhibit the activity of the KIT protein. The     FDA approved sunitinib in 2006 for patients with GIST. It has been shown that sunitinib     malate works in these patients because of its activity against the KIT protein. The FDA also     approved Sunitinib malate in 2006 for the treatment of metastatic kidney cancer, where its     effectiveness is probably due to its ability to block a different set of proteins.      Sunitinib malate has not been approved by the FDA for the treatment of metastatic melanoma.   "
212284|NCT00631644|"     This study will explore the eating habits of adolescents and determine if eating behavior is     linked to genetics.      Healthy adolescents between 13 and 17 years of age may be eligible for this study. Candidates     come to the NIH Clinical Center at 8:00 AM to be screened with the following:        -  Medical history and brief physical examination, including height, weight, and body fat          measurements. Body fat is measured using a device called a Bod Pod. The adolescent sits          inside the device for about 5 minutes and the machine determines body fat by measuring          air movement. The adolescent must wear a tight-fitting swimsuit for this test.        -  Urine test to look for sugar or protein in the urine and to test for pregnancy in          females.        -  Blood tests for routine chemistries and for gene studies related to eating behaviors.        -  Questionnaires and interviews about the adolescent s general health and eating habits.        -  Acclimatization to test meal conditions for the study. The adolescent is given a          breakfast shake to drink.      Participants come to the NIH Clinical Center at 10:30 AM for laboratory meal testing. At this     visit, the adolescent does the following:        -  Eats food from a buffet of everyday foods that most kids eat.        -  Fills out questionnaires.        -  Tastes and rates the flavor of a variety of snack foods.   "
212285|NCT00631657|"     To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081,     SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia.     Primary efficacy variable is Total Sleep Time (TST).   "
212286|NCT00631670|"     The purpose of this research study is to determine if Stereotactic Body Radiation Therapy     (SBRT) is a good way to treat tumors near the spinal cord. Patients will either receive a     single treatment or 25 days of treatment given once-a-day, Monday through Friday for about 5     continuous weeks. Our protocol uses life expectancy, patient preference, and tumor size to     determine whether SBRT is delivered with 1 or 25 treatments. The single treatment dose is 15     Gy. The 25 treatment group is 70 Gy at 2.8 Gy/treatment.   "
212287|NCT00631683|"     Failure to wean from mechanical ventilation (failure to get the patients off the breathing     machine) is associated with prolonged stay in the intensive care unit and increased risk of     death. Some patients have difficulty successfully getting off the ventilator and breathing on     their own. Usually this difficulty is due to lung problems. But sometimes it is due to heart     problems, or heart failure. To improve a patient's chances of successfully getting off the     ventilator early, it is helpful to the doctors to know if patient has heart failure and to     measure how severe. With the new monitoring system being studied here, doctors may be able to     detect and measure heart failure more easily.      A new monitor (Vigileo TM) that is connected with a specific cable (Flo-TracTM) to a catheter     that is inside the patient's artery (arterial line) has lately been developed. This monitor     can estimate the amount of blood that the heart is pumping per minute, known as cardiac     output. The heart is supposed to pump blood harder when a patient is being weaned from the     breathing machine. With the above mentioned monitor, we hope to detect those patients whose     hearts are weak and are not pumping as hard as they should.   "
212288|NCT00631696|"     This study is being performed as a Phase IV FDA commitment study and is being powered     adequately to assess changes in sperm concentration, FSH and testosterone in healthy male     subjects treated with pregabalin as compared to placebo, in addition to confirming lack of     effects on sperm motility.   "
212300|NCT00631852|"     This study was designed to explore the changes brought about by gelatin encapsulated extract     of American Ginseng Root (LEAG) in breast cancer tumors and surrounding normal breast     epithelial cells. Various tumor biomarkers, as well as inflammatory mediators, will be     examined in tissue following LEAG treatment.   "
212301|NCT00631865|"     The purpose of this study is to investigate the efficacy and safety of autologous     transplantation of melanocytes in patients with vitiligo.   "
212359|NCT00623207|"     The aim of this study is to evaluate the Safety and feasibility of atropine added during     treadmill stress testing in patients with chronotropic incompetence or poor exercise     capacity.      Our hypothesis is that we can increase heart rate by using atropin in these patients, so we     will achieve more conclusive results.   "
212289|NCT00631709|"     The purpose of this study is to evaluate the potential clinical and economic benefits of     using CareLink remote management for pacemaker follow-up.      Study Objectives include:        1. To determine clinician perceived quality of care for CareLink remote follow-up.        2. To determine patient satisfaction with CareLink follow-up.        3. To estimate the time required to perform patient follow-up via CareLink remote          transmissions.        4. To determine the percentage of regular CareLink follow-ups that do not require further          in-clinic review of the patient.        5. To estimate potential patient cost avoidance for one year of follow up incorporating          CareLink.        6. To evaluate compliance to scheduled CareLink transmissions with the remote management          system      This is a non-randomized, multi-center, prospective study in which 120 patients who have a     pacemaker are enrolled into the study and receive a CareLink monitor. Patients will replace     their regularly scheduled pacemaker clinic follow-up visits with a CareLink remote     transmission for 12months.      Patients will require a test transmission within 1 month after they receive their CareLink     monitor. Afterwards, patients are followed via CareLink transmissions as per their usual     clinic schedule for 12 months.   "
212290|NCT00631722|"     This study attempts to observe the efficacy (response time) and safety of the     second-generation antipsychotic agent-quetiapine versus the first-generation antipsychotic     agent-haloperidol, in treating acute schizophrenia episode and to evaluate the effect of the     effectiveness of acute schizophrenia episode on long-term tolerability.   "
212307|NCT00631969|"     This study investigates the safety and efficacy of a new dosage form of Vardenafil, an     orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo     (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase,     patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be     determined by laboratory and other evaluations. Efficacy will be determined by the results of     different questionnaires and the patient diary that will be used.   "
212308|NCT00631982|"     In vitro maturation of oocytes after minimal gonadotropin stimulation in patients with     polycystic ovaries, to prevent cases of ovarian hyperstimulation.   "
212339|NCT00622947|"     The aim of the present study is to compare the antidepressant effect of low frequency rTMS     applied over the right temporal cortex with sham stimulation.   "
212291|NCT00631735|"     This study is a qualitative, phenomenological research design. The research question is the     lived experience of adult oncology patients undergoing chemotherapy being touched and     touching. The researcher will conduct minimally-structured interviews with a set of follow-up     interviews to verify interpretations and ascertain additional participant reflections on the     phenomenon of touch. The purpose of this study is to describe the sensation of touch in adult     oncology patients who are actively undergoing chemotherapy treatment. The primary objective     is to identify the essences of multiple meanings of touch to these patients. The importance     of touch in physiological development, learning patterns, and stress reduction has been     demonstrated in humans and animals through years of research (Field, 2000). Based on research     which indicates touch therapies provide a significant amount of symptom relief and reduction     in anxiety, a growing number of hospitals and clinics are integrating massage therapy into     services provided to patients in order to ameliorate many symptoms of diagnosis and/or     treatment-related discomfort. Examples are the integrative medicine programs at Memorial     Sloan-Kettering Cancer Center and George Washington University Medical Center which include     touch therapy modalities. Research focusing on the embodied experience of sensory phenomena     such as touch is important to provide the basis for more effective care. No studies to date     have focused on the self-reported experience of the cancer patient with regard to what touch     means to these individuals, particularly those actively in treatment with intravenous     chemotherapy. The embodied sensation of touch in these people is important to understand in     order to provide more effective touch-based interventions and also to increase awareness of     direct care staff, including nurses, of the profound and complex effect that all forms of     touch have on those who are physically and psychically vulnerable.   "
212292|NCT00631748|"     This placebo-controlled trial will test the effectiveness of Seroquel XR™ for the treatment     of cocaine dependence in non-psychotic individuals who are cocaine dependent.   "
212293|NCT00631761|"     Develop a tool to objectively quantify technical skills necessary to perform diagnostic     cystoscopy (using Objective Structured Assessment of Technical Skills- OSATS).      Develop criteria by which surgeons skills in diagnostic cystoscopy can be evaluated or     judged.      Develop an intervention (1.5 hour workshop) which can be replicated by other residency     programs in order to enhance learning of diagnostic cystoscopy. The workshop should be     adequate for practicing Gynecologists as well as they already have experience with diagnostic     hysteroscopy which uses many of the same concepts.   "
212294|NCT00631774|"     This is a phase 4, 24-week, randomized, parallel, open-label study of a meal replacement     program with Glucerna SR in obese Asian participants with type 2 diabetes. The duration of     each subject's participation will be approximately 28 weeks, including a lead-in period of 2     weeks and a 2-week post-treatment telephone follow-up. A sufficient number of Asian subjects     with type 2 diabetes who have a BMI 18 between 25-40 kg/m2 and meet all the inclusion     criteria and none of the exclusion criteria will be entered into the study to randomize     approximately 60 subjects. Approximately 60 participants will be randomized to receive either     (1) a meal replacement program with Glucerna SR on top of the Exchange-diet plan (EDP) or (2)     an caloric-matched EDP only. The primary objective of this study is to evaluate the effect of     a diet program including Glucerna SR as a meal replacement on postprandial glucose response     after using Glucerna SR for 24 weeks in obese Asian subjects with type 2 diabetes   "
212295|NCT00631787|"     This study will try to determine what causes toxic side effects of stem cell transplantation,     such as increased blood pressure, increased heart rate, decreased kidney function and     abnormal heart rhythms. Stem cells are used to treat various diseases, including cancer,     aplastic anemia and sickle cell disease. The cells may be given fresh to the patient or they     may be preserved first with a chemical called DMSO and frozen for later use. Some stem cell     transplant procedures include infusion of red blood cells along with the stem cells. This     study will examine whether side effects of stem cell transplants are associated with the DMSO     preservative in frozen cells or with hemoglobin (a protein released from defrosted red blood     cells) or neither of these factors.      Healthy volunteers and patients scheduled to receive a stem cell transplant may be eligible     for this study. Candidates must be between 10 and 80 years of age.      Transplant patients will undergo a stem cell transplant. The cells are infused through a     catheter placed in a vein for the procedure. Depending on the patient s requirements, the     infusion may or may not include red blood cells and may or may not contain DMSO. Healthy     volunteers undergo a 4-hour saline infusion. The saline (water mixed with salt) is infused     through a catheter (plastic tube) placed in a vein in the arm. In addition, all participants     have the following tests and procedures:        -  Heart monitoring: Healthy volunteers wear a portable heart monitor, attached to the          chest using four stickers, for 24 hours starting the morning of the infusion. Transplant          patients wear the same device for 48 hours, starting the morning before the infusion.        -  Blood draws and urine collections before, during, just after and the morning after the          infusion of saline or stem cells.        -  Heart ultrasound before, during or just after and the morning after the infusion.        -  Peripheral artery tonometry: A small cup is placed on one finger of each hand to measure          blood flow in the finger. A blood pressure cuff is inflated around the lower arm and          tight pressure is maintained for about 5 minutes.   "
212296|NCT00631800|"     The purpose of this study is to evaluate the safety (including tolerability),     pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a     3-dose regimen on Study Days 0, 7, and 14.   "
212297|NCT00631813|"     The purpose of this study is to determine which dose of prucalopride is safe and effective in     patients with chronic constipation.      Hypothesis:      Prucalopride 1 and 2 mg bid are safe and effective for the treatment of chronic constipation     whereas 0,5 mg is a suboptimal dose.   "
212298|NCT00631826|"     The evaluation of any relationship between the rotational resistance of the shoulder and     shoulder flexibility with throwing arm injuries in professional and college level pitchers.   "
212299|NCT00631839|"     The purpose of this study is to evaluate clinical, dosimetrical, functional, biological and     genetic factors in predicting chemo-radiotherapy induced lung and esophagus injury.   "
212302|NCT00631878|"     Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and     Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the     Prevention of S. epidermidis Infection. The purpose of this study is to evaluate the safety     and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.   "
212303|NCT00631904|"     The purpose of this study is to monitor and follow non-pacemaker dependent patients with     implanted permanent pacemakers, who undergo medically required Magnetic Resonance Imaging     (MRI) scans.      Patients with pacemakers are currently excluded from obtaining MRI scans. MRI scanning is now     the imaging of choice for a number of neurological, vascular, or musculoskeletal conditions.      Data suggests that patients with pacemakers, when properly monitored, can safely undergo MRI     scanning, though the largest published study to date consists of 54 patients, and no long     term follow-up has been published.      Though MRI cardiac scanning has been demonstrated to produce local tissue heating at the     pacemaker lead tip, the long term effect of tissue heating on lead stability is unclear.      This study will evaluate patients with permanent pacemakers undergoing medically indicated     MRI scanning.      Patients will be followed for one year at 3, 6, and 12 months. Data collected will evaluate     change in pacing thresholds over time as well as cardiac troponin I, creatinine kinase MB     function, and myoglobin levels within the first 12 hours following the scans, side effects,     symptoms, the need to make pacemaker program changes, and possible artifacts created by the     pacemaker on the MRI scan.   "
212313|NCT00622609|"     GSK249320 is a monoclonal antibody directed against myelin associated glycoprotein (MAG), a     protein that inhibits axonal regeneration. GSK249320 acts as a MAG antagonist, and through     this activity it is hypothesised that it will enhance recovery from neuronal degeneration     following acute axonal injury, which occurs in spinal cord injury or stroke.   "
212314|NCT00622622|"     The purpose of this study is to evaluate the safety, tolerability and immune response of     different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with     gemcitabine and to determine the recommended phase II dose.   "
212315|NCT00622635|"     This study was conducted to provide detailed information on the efficacy of indacaterol in     terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a     24 hour time period.   "
212316|NCT00622648|"     The primary objective:        -  To demonstrate in patients hospitalized for an acute medical illness that enoxaparin          with Graduated Elastic Stockings is superior to enoxaparin-placebo with Graduated          Elastic Stockings on overall mortality at day 30 after randomization.      The secondary objective:        -  To compare, in patients hospitalized for an acute medical illness, enoxaparin with          Graduated Elastic Stockings versus enoxaparin placebo with Graduated Elastic Stockings          on overall mortality at day 90 after randomization.        -  To evaluate the safety of enoxaparin VTE prophylaxis in patients hospitalized for acute          medical illness with respect to major hemorrhage, total bleedings, heparin induced          thrombocytopenia, adverse events and serious adverse events .   "
212317|NCT00622661|"     This study is designed to investigate associations of low- and high-glycemic load diets with     biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for     cancer risk.   "
212318|NCT00622674|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Giving bortezomib     together with cetuximab may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     given together with cetuximab in treating patients with advanced solid tumors.   "
212330|NCT00622830|"     This study is being conducted to provide safety, tolerability, PK and PD data in repeat     dosing that will allow further studies with darapladib in Japanese patients   "
212331|NCT00622843|"     Purpose: To study the immune response of the newly licensed pneumococcal conjugate vaccine     (PCV) in comparison to the pneumococcal polysaccharide vaccine (PPV) to determine if a     significantly better immunologic response to boosting can be elicited in patients previously     vaccinated with PPV.   "
212319|NCT00622687|"     This study compared the efficacy of different dosages of long-term iloprost treatment on     Raynaud's phenomenon, ulcer healing, skin thickening, and progression of internal organ     sclerosis in systemic sclerosis (SSc).      Methods. 50 SSc patients were 1:1 randomised either for maximally tolerated dose up to 2     ng/kg body weight [bw] per minute or low dose (0.5 ng/kg bw per minute) intravenous iloprost     administration, for six hours daily over 21 days. The effect on RP, ulcer healing, skin     thickness, oesophagus function, lung involvement as assessed by lung function parameters FVC     and DLCO, and side effects were measured.      Conclusions. The efficacy of prolonged administration of iloprost is also achieved with low     dose iloprost by long term treatment. The effects suggest a disease-modifying capability of     iloprost, but further studies are needed to proof this hypothesis.   "
212320|NCT00622700|"     The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram     per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of     participants presenting with their first clinical episode consistent with multiple sclerosis     (MS) to clinically definite multiple sclerosis (CDMS).      The secondary objectives were:        -  To demonstrate the effect of teriflunomide, in comparison to placebo, on:             -  Reducing conversion to definite multiple sclerosis (DMS)             -  Reducing annualized relapse rate (ARR)             -  Reducing disease activity/progression as measured by Magnetic Resonance Imaging               (MRI)             -  Reducing accumulation of disability for at least 12 weeks as measured by the               Expanded Disability Status Scale (EDSS)             -  Proportion of disability-free participants as assessed by the EDSS             -  Reducing participant-reported fatigue        -  To evaluate the safety and tolerability of teriflunomide        -  To evaluate the pharmacokinetics (PK) of teriflunomide        -  Optional pharmacogenomic testing aimed at assessing the association between the main          enzyme systems of teriflunomide metabolism and hepatic safety, and other potential          associations between gene variations and clinical outcomes   "
212321|NCT00622713|"     This study is designed to confirm the efficacy, the tolerability, the patient compliance and     the caregiver satisfaction with rivastigmine target patch size 10 cm^2 in patients with     probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting   "
212322|NCT00622726|"     The purpose of this study was to determine the efficacy and additional advantages of     intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.   "
212323|NCT00622739|"     This is a 6 week, open-label, blinded-rater, randomized, controlled, pilot study designed to     determine the dosing, safety and efficacy of ziprasidone in the treatment of pediatric     bipolar disorder (PBD). In this pilot study we are comparing the efficacy of rapid versus     slow dose titration of ziprasidone in PBD. The investigators hypothesize that subjects on     ziprasidone monotherapy will have a reduction in manic symptoms. Also, the investigators     hypothesize that slower titration of ziprasidone will result in lesser side effects which     will assist in medication compliance as measured by patient report and pill count.   "
212324|NCT00622752|"     This randomised, placebo-controlled study is designed to explore the effects of EVT 302 both     with and without concomitant nicotine replacement therapy (NRT) on craving and withdrawal in     smokers after short term deprivation of cigarettes.   "
212353|NCT00623129|"     RATIONALE: Electroacupuncture may help relieve chronic dry mouth caused by radiation therapy.     It is not yet known whether electroacupuncture is more effective than a placebo in treating     chronic dry mouth caused by radiation therapy in patients with head and neck cancer.      PURPOSE: This randomized clinical trial is studying electroacupuncture to see how well it     works compared with a placebo in treating chronic dry mouth caused by radiation therapy in     patients with head and neck cancer.   "
212325|NCT00622765|"     This study investigates the effectiveness and safety of 12 weeks of treatment with     JNJ-16269110 (R256918), in overweight and obese patients. The primary measure of     effectiveness is the change in body weight at a clinically relevant dosage level during     treatment. Additional measures include body mass index (BMI), DEXA (dual X-ray absorptiometry     which is a specialized x-ray test that measures body composition), fasting glucose, lipid     levels, and blood pressure. Safety assessments performed during the trial include laboratory     tests, vital sign measurements, and adverse event reporting.   "
212326|NCT00622778|"     The purpose of this study is to try to prove the worth of the two (2) Serum Proteins S-100     Beta and NSE in combination with a diagnostic algorithm to help to establish diagnosis in     patients with minor head injury.   "
212327|NCT00622791|"     Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to     several drugs, including propofol. Few studies, however, have tested if propofol     pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic     effect of propofol after CPB. This study was designed to test the hypothesis that changes in     the PK of propofol contribute to an increase in its hypnotic effects after CPB as evidenced     by changes in bispectral index (BIS) values.      Twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1)     CPB groups and 2) off-pump coronary artery bypass graft. Bispectral Index values and blood     samples for plasma propofol concentration measurements will be collected along the surgery     and up to 12 hours in the post-operative period. Plasma propofol concentrations, Bispectral     index values and propofol PK will be compared between the groups.   "
212328|NCT00622804|"     The purpose of this study is to evaluate the degree of bile reflux and gastric stasis     according the reconstruction methods after distal subtotal gastrectomy for gastric cancer,     and to find out the proper method. We collect ninety patients who undergo distal gastrectomy     for gastric cancers for this study from 5 institutions and randomly divide into 3 groups     according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy     (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).   "
212329|NCT00622817|"     This was a randomized, double blinded, controlled trial. The aim of the study was to compare     xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis.      The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine     inhalation for treatment of bronchiolitis.      Signed informed consent was obtained from a parent of each child. And the human ethics     committee of our hospital approved the study according to the principles of the Declaration     of Helsinki.(Approved - 2002)      Patients:      65 infants who were admitted to Pediatric A- a general pediatric ward, in Schneider     Children's Medical Center because of bronchiolitis during winter in two consecutive years     2004-2005.      The inclusion criteria were: Full term previously healthy Infants, ages 1-12 months, after     informed consent was signed with clinical presentation of mild to moderate bronchiolitis     according to a clinical score .Exclusion criteria were as follows: prematurity, congenital     lung or cardiac disease, infants who had past hospitalization due to respiratory illness and     severe bronchiolitis (score>7 with a range scale 0-10).   "
212332|NCT00622856|"     A three arms, open, randomized interventional study including 100 participants in order to     evaluate the cost-efficacy of psychological intervention for strengthening parental authority     among parents of diabetic adolescents with poor glycemic control.      All participants will be randomized into three groups:1.The first group will get a     psychological treatment in order to strengthen the parent's authority. 2.The second group     will get an education of a nurse and a dietician. 3.The third group will serve as a control     group and will not go through an intervention.      The following data will be analyzed during the study: 1.Changes in HbA1c. 2.Changes in     parents authority. 3.Changes in the diabetes treatment by the adolescents. 4.Consumption of     health services. 5.The costs of all psychological treatments.   "
212333|NCT00622869|"     This trial was designed to address important issues that impact recipients of liver     allografts as well as clinicians, ie, renal function, reduction or discontinuation of     tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus     (HCV) positive patients.   "
212334|NCT00622882|"     The primary objective is to determine if early infectious disease (ID) consultation (defined     as within 48 hours of a positive blood culture) will reduce mortality rates from     Staphylococcus aureus bacteremia (SAB). This study will also determine if such consultations     could reduce the duration of hospitalisation, recurrence and financial costs in patients with     this infection.   "
212335|NCT00622895|"     The purpose of the study is to examine the safety and effectiveness of a reduced intensity     conditioning regimen and allogeneic bone marrow transplant for people with systemic     sclerosis. In an allogeneic bone marrow transplant procedure, bone marrow is taken from a     healthy donor and transplanted into the patient. Bone marrow can be donated by a family     member or an unrelated donor who is a complete tissue type match.      Participants will receive the chemotherapy and low dose radiation conditioning regimen     consisting of the following: Fludarabine will be given intravenously for 5 days.     Cyclophosphamide will be given intravenously on the first and second day. After completing     the fludarabine and cyclophosphamide, patients will receive a single low dose of total body     irradiation. The next day, patients will receive the allogeneic bone marrow transplant. On     the third and fourth day after the transplant, patients will receive high dose intravenous     cyclophosphamide. This is given to help prevent two complications: (1) graft rejection, which     occurs when the body's immune system rejects the donor bone marrow, and (2) graft-versus-host     disease (GVHD), which is when the donor immune cells attack the patient's normal tissues. On     the fifth day after the transplant, patients will start receiving two additional medications:     tacrolimus and mycophenolic acid (MPA, Myfortic), to help prevent GVHD. Patients will receive     mycophenolic acid for about 5 weeks and tacrolimus for about 6 months. Also beginning on the     fifth day after the transplant, patients will receive daily injections of a growth factor     called granulocyte-colony stimulating factor (G-CSF), which is a protein that increases the     white blood cell count; G-CSF will be continued until the patient's white blood cell count     has returned to normal levels.      Patients will remain closely monitored either in the outpatient clinic setting or in the     hospital for approximately 2-3 months after the transplant, but possibly longer if there are     complications. Follow-up study visits will occur at 6 months and then at 1, 2, 3, 4, and 5     years after the transplant. Study researchers will keep track of the patient's medical     condition after leaving the transplant center by phone calls or mailings to patients and     their doctors once a year for the rest of the study participants' lives.   "
212336|NCT00622908|"     To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day     (TID) for 5 days compared to vehicle three times a day for 5 days in the treatment of     bacterial conjunctivitis   "
212337|NCT00622921|"     Purpose: Phase I focus groups with clinicians and patients will gather qualitative data to     focus and inform the content of Phase II. In Phase II, 12 weeks of psychotherapy will be     offered to evaluate feasibility and potential efficacy of a couples-based, integrated     treatment for men with PTSD and alcohol dependence.      Hypotheses: We predict that this experimental psychotherapy, Partners Encouraging Abstinence     and Coping with Emotions (PEACE), will reduce patient drinking, reduce PTSD symptoms, and     improve relationship functioning.   "
212340|NCT00622960|"     The purpose of this proposed randomized, controlled trial is to compare the effects of high     monounsaturated fat diets and high carbohydrate diets on body weight, body composition,     glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one     year. At present, no such studies of free-living subjects have been performed. The specific     aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat     diet will produce greater weight loss/body fat loss and more successful weight maintenance     than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an     improved lipid profile and better glycemic control than a high carbohydrate diet.   "
212341|NCT00622973|"     Preoperative detection of lymph node metastases in patients with prostate or bladder cancer     is crucial for selection of the appropriate treatment strategy (surgery, androgen deprivation     with/or without radiation therapy or chemotherapy) and thus for patient prognosis. Until now     CT or MRI have been the modalities of choice for preoperative staging procedures. However,     current morphological assessment of lymph nodes based on size and shape is unable to detect     smaller metastases or liable to give false positive results on lymph nodes with reactive     hyperplasia. We hypothesize that USPIO-enhanced MRI combined with DW-MRI will be able to     detect pelvic lymph node metastases preoperatively with high sensitivity and specificity.   "
212342|NCT00622986|"     This study is designed to determine whether an extract of Cimicifuga Foetida L. is safe and     efficacious to relieve the climacteric symptoms of Chinese women   "
212343|NCT00622999|"     The prevalence of malnutrition in patients with colorectal cancer is recorded. We want to     find out, if a malnourished patient has more complications after the elective surgery.   "
212344|NCT00623012|"     The objective of this study is to evaluate feasibility, toxicity and efficacy of using     Rapamycin to prevent chronic graft-versus-host-disease (GVHD) during and after the tacrolimus     taper in recipients of allogeneic stem cell transplant.      Our hypothesis is that the T cells that can cause chronic GVHD are suppressed but not     eliminated by calcineurin inhibitors. Therefore, when the calcineurin inhibitors are     discontinued, the T cells may get activated and result in GVHD. Rapamycin on the other hand     will allow anergy formation and thus when discontinued, T cells should not get activated. The     schedule is designed to have therapeutic rapamycin levels as the tacrolimus is discontinued.     Rapamycin will be continued as a single agent for additional 4 weeks and be tapered off in     two weeks.   "
212345|NCT00623025|"     The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.   "
212358|NCT00623194|"     This trial is conducted in Europe. The aim of this research is to assess the safety of     continuous treatment with insulin detemir following participation in trial NN304-1689     (NCT00435019) on antibody development.   "
212346|NCT00623038|"     It is of importance to predict the risk to develop problems after birth. Virginia Apgar     developed a score more than 50 years ago that allows a description of the condition of     newborns at 1, 5 and 10 minutes after birth. The Apgar score is used for every newborn,     however, its applicability is restricted in preterm infants and resuscitated newborns. Thus,     two scores have been suggested recently - the Specified Apgar and the Expanded-Apgar score.     By combining both scores the Combined-Apgar has been developed as a new delivery room tool.      The purpose of this study is to determine whether the Combined-Apgar predicts poor outcome     better than the Specified- or Expanded Apgar alone.   "
212347|NCT00623051|"     This study is aimed at demonstrating whether or not Male Circumcision can be used as an     effective public health prevention tool that will have an impact on HIV prevalence in the     South African population.   "
212348|NCT00623064|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, and gemcitabine, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving lapatinib together with combination chemotherapy may kill     more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when     given together with cisplatin and gemcitabine as first-line therapy in treating patients with     locally advanced or metastatic urothelial cancer.   "
212349|NCT00623077|"     RATIONALE: A peripheral blood stem cell transplant or bone marrow transplant using stem cells     from the patient may be able to replace immune cells that were destroyed by chemotherapy and     image-guided intensity-modulated radiation therapy used to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bone marrow     radiation therapy followed by an autologous stem cell transplant in treating patients with     high-risk or relapsed solid tumors.   "
212350|NCT00623090|"     Prostate cancer (PCa) is the leading cancer diagnosis among men and the second leading cause     of male cancer death. However, screening asymptomatic men remains controversial, as early     diagnosis and treatment of PCa has not yet demonstrated reduced disease-related mortality in     a randomized trial. The goal of the current study is to develop and assess widely accessible     methods to assist men in making informed decisions about PCa screening. We will compare the     efficacy of a new web-based, interactive decision support approach to our existing     print-based PCa screening decision tool, among a diverse sample of male primary care     patients. Abundant evidence documents the expanding role of the Internet in increasing access     to and understanding of health information and the need for systematic evaluations of     Internet-based interventions. A novel aspect of the proposed trial will be our focus on     cognitive biases as a factor that has limited the success of previous information-based     interventions. Specifically, we will evaluate: 1) confirmation bias and 2) short-term     consequences bias.   "
212351|NCT00623103|"     The purpose of this study is to provide long-term safety data for rivastigmine capsule and     transdermal patch treatments, in particular the effect of rivastigmine on worsening of the     underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately     severe dementia associated with PD.   "
212352|NCT00623116|"     Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome     in Finland.   "
212354|NCT00623142|"     The purpose of this study was to determine if treating patients who have coronary heart     disease with hyperbaric oxygen (HBO) prior to coronary artery bypass graft (CABG) surgery     reduces injury to the heart and vascular system during and after surgery. Furthermore, this     study also aims to identify some of the post CABG clinical effects of HBO treatment prior to     CABG.   "
212355|NCT00623155|"     Recent, randomized controlled trials conducted in areas of perennial malaria transmission     have shown that intermittent preventive treatment (IPT) given at the time of vaccination     reduced the incidence of the first episode of malaria and severe anaemia during the first     year of life by more than 50% without there being any rebound in the subsequent year.     However, in countries such as Mali, where malaria is highly seasonal and prevalent in older     children, IPT in infants may not be the optimum way in which to use antimalarial drugs to     prevent malaria. An alternative approach is to give intermittent preventive treatment to     children at risk just during the rainy season. Here we propose (i) to evaluate the impact of     two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the     incidence of malaria disease in children of 6 months to 10 years in an area of seasonal     transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo     response of P. falciparum to SP; (iii) to assess the potential rebound effect of this     strategy on the subsequent transmission season after the cessation. Children 6 months-10     years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks     interval or no IPT during the transmission season and will followed up for 12 months.     Subjects will be also followed during the subsequent transmission season to assess possible     rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to     assess the in vivo response during both periods.   "
212356|NCT00623168|"     Hemorrhagic Fever with Renal Syndrome (HFRS) is caused by a virus acquired by contact with     chronically infected rodent hosts. HFRS is present throughout Korea. Treatment consists     mainly of supportive care with careful attention to control of blood pressure and fluid     balance and/or dialysis. Early initiation of IND Intravenous Ribavirin has been shown to be     an effective treatment for HFRS and may prevent the need for dialysis. It is important to     initiate therapy based on a diagnosis consistent with HFRS and a history that makes exposure     likely. This study will monitor the clinical events that occur with HFRS as well as the     safety and efficacy of Ribavirin.   "
212357|NCT00623181|"     To describe any degree of preference for the route of administration of Fluzone influenza     vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.      To collect safety data, injection site reactions, and systemic reactions, through Day 7     post-vaccination; SAEs through day 28 post-vaccination   "
212360|NCT00623220|"     The primary objective of the proposed study is to show that inhaled equimolar mixture of     oxygen and nitrous oxide (EMONO) will reduce pain associated with retinal exam in the preterm     infant, as compared to the current standard treatment (oral sucrose and topical anaesthesia).      The investigators also aim to show that EMONO can be used safely in preterm neonates     undergoing retinal exam, and will not result in any increase in apnea, bradycardia, or     desaturation in the 24 hours following the exam. Finally, the investigators aim to show that     EMONO will keep the infant calm, and make retinal examination easier and less traumatic.   "
212361|NCT00623233|"     To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in     patients with advanced breast cancer.   "
212362|NCT00623246|"     Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops     breathing or experiences shallow breathing for short periods of time during sleep. The most     common treatment for OSA is the use of a continuous positive airway pressure (CPAP) machine,     but many people have trouble adhering to the treatment schedule. This study will evaluate the     effectiveness of two behavioral therapy programs used in combination with CPAP for improving     treatment adherence in people with OSA.   "
212363|NCT00623259|"     Monocentric study to assess the safety and immunogenicity of the recombinant MVA-HIV     multiantigen vaccine MVA-mBN120B in HIV-infected subjects. 15 subjects will receive     immunizations at day 0, after 4 and 12 weeks at a dose of 2E8 TCID50 MVA-mBN120B. The vaccine     will be administered subcutaneously.   "
212364|NCT00632021|"     Many people who have recently left the hospital have difficulties managing their medications,     and medication errors are common. Patients with low health literacy levels may have a     particularly difficult time understanding medication dosing and instructions. This study will     evaluate a literacy-focused program that provides educational assistance from pharmacists at     the time of hospital discharge to people hospitalized with heart problems.   "
212365|NCT00632034|"     The aim of this trial is to determine the safety and tolerability of expanded autologous     progeny of an adult CD34+ (haemopoietic) stem cell subset when infused directly into the     tibial artery of patients with recent tibial fracture. The trial will also seek to determine     clinical improvement or deterioration by measurement of clinical parameters such as, length     of time to union of the fracture, changes in bone mineral density, improvements in pain     scores (VAS), functional ability (TUGT) and IPAQ scores.   "
212366|NCT00632047|"     RATIONALE: Health education programs and screening methods, such as clinical breast     examination and examination of the cervix, may help reduce the number of women who develop     breast cancer and cervical cancer.      PURPOSE: This randomized clinical trial is studying the early detection of breast cancer and     cervical cancer in women in India.   "
212367|NCT00632060|"     The specific aims of this research project are to determine feasibility of, and the     comparative treatment effect size for, conducting a larger clinical trial of     Manual/Manipulative Therapy (M/MT) in restoring peak performance in military personnel in     operational environments and to evaluate the ability of the addition of M/MT to standard care     to decrease pain and increase function for patients with low back pain.      The following two hypotheses will guide the data collection:        1. The primary hypothesis is that the addition of acourse of M/MT to standard care for low          back pain will decrease pain at 4 weeks when compared to standard care alone        2. In addition, the secondary hypothesis will be that the addition of a course of M/MT to          standard care for low back pain will decrease pain and increase function over 2 and 4          weeks when compared to standard care alone   "
212368|NCT00632073|"     Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government     Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5     receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells     that fight infection). Previous studies in HIV treatment-experienced patients have shown that     vicriviroc is safe and effective. The purpose of this study is to determine the effect of     vicriviroc on HIV RNA levels in cerebrospinal fluid (CSF).   "
212369|NCT00632086|"     Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg     with respect to salicylic acid.   "
212370|NCT00632099|"     The purpose of this pilot treatment trial is to evaluate the efficacy of oral micronized PROG     in cocaine-dependent women. Since we have shown (Evans & Foltin, 2006) that oral micronized     PROG attenuates the positive subjective effects of smoked cocaine in females, but not in     males, and we have preliminary data indicating that oral micronized PROG also reduces smoked     cocaine self-administration in the laboratory, PROG appears to be an ideal potential     candidate medication to evaluate in cocaine-dependent women. Prior to randomization to     treatment, women will reside inpatient for one week to ensure cocaine abstinence since one of     the primary outcome measures will be time to cocaine relapse.   "
212371|NCT00632112|"     Continuous albuterol has become the standard of care for patients in status asthmaticus. We     have previously performed an in-vitro study comparing 4 different brands of continuous     nebulizers. We now want to compare the in-vitro with the in-vivo performance of the brand we     use. we hypothesize that there will be no difference between in-vivo and in-vitro results.   "
212372|NCT00632125|"     Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of     relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney     Disease (CKD) subjects receiving HX575 epoetin alfa i.v.   "
212373|NCT00632138|"     RATIONALE: Personalized training by a health professional may improve urinary incontinence.     It is not yet known whether pelvic floor muscle training and biofeedback are more effective     than standard therapy in improving urinary continence after radical prostatectomy or     transurethral resection of the prostate.      PURPOSE: This randomized phase III trial is studying pelvic floor muscle training and     biofeedback to see how well it works compared with standard therapy in men who have undergone     radical prostatectomy or transurethral resection.   "
212374|NCT00632164|"     A study to determine if a chiropractic adjustment in the cervical spine will effect the     parasympathetics and a chiropractic adjustment in the thoracic spine will effect the     sympathetics.   "
212425|NCT00632918|"     The purpose of this study is to investigate the effects of heart rates (including maximum     heart rate, average heart rate and minimum heart rate) and variability of heart rate on image     quality of DSCT coronary angiography without control of heart rate experienced in our     department.   "
212375|NCT00632190|"     RATIONALE: New diagnostic procedures, such as spectroscopy, may be a less invasive way to     check for dysplasia and neoplasia in the cervix. Spectroscopy may also used as a screening     test to help doctors find cervical cancer sooner, when it may be easier to treat.      PURPOSE: This clinical trial is studying how well spectroscopy works in diagnosing dysplasia     and neoplasia in the cervix in women undergoing colposcopy or Pap testing.   "
212376|NCT00632203|"     The main objective of this study is to investigate whether administration of maintenance     temozolomide following standard treatment could possibly prevent or delay the onset of brain     metastases in patients with controlled non-small cell lung cancer (NSCLC).   "
212377|NCT00632216|"     The study in the labeled and real conditions of prescription of Actonel will investigate the     satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also     measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12     weeks of treatment with risedronate 35 mg Once A Week.   "
212378|NCT00632229|"     Obsessive-compulsive disorder (OCD) is a common, chronic, and oftentimes disabling disorder.     The only established treatments for OCD are a specific form of Cognitive Behavioral Therapy     (CBT) and the Serotonin Reuptake Inhibitor medications (SRIs). Few patients with OCD     experience complete symptom resolution with either modality and even after two consecutive     SRI trials, as many as 30%-40% of patients fail to derive a satisfactory response.     Pharmacological options for these SRI-resistant cases include switching to a different     antidepressant, increasing the dose of SRI, or augmentation with another agent.      Previous studies showed that approximately 33-50% of OCD patients who have not had an     adequate response to SRI medication had a positive response when an atypical antipsychotic     medication was added. However, the problematic acute and long-term side effects of these     medications are of concern and, at times, limit their use. Paliperidone has a number of     advantages over these medications including fewer drug interactions and better tolerability.     Thus, this study is designed to determine whether paliperidone augmentation of an existing     medication is effective relative to taking a placebo and your existing medication.   "
212379|NCT00632242|"     To evaluate the overall safety and tolerability of ARC1779, a therapeutic oligonucleotide     (aptamer) in patients with three types of von Willebrand Factor related platelet disorders.   "
212380|NCT00632255|"     Imatinib has revolutionised the treatment of chronic myeloid leukaemia (CML). The first     clinical trials were conducted in 1998 in patients with advanced disease, and by 2002     imatinib was established as the standard therapy for all patients including those recently     diagnosed. In spite of overwhelming evidence about its efficacy we still need to gain more     knowledge about issues related to long term treatment with imatinib such as why some patients     respond better than others, the development of side effects and the quality of life.   "
212381|NCT00632268|"     The primary end-point of this study is to evaluate the objective response rates, and the     secondary end-points are overall survival, progression-free survival and safety profile of     low-dose RAD001 (everolimus) plus cisplatin and HDFL (weekly 24-hour infusion of high-dose     5-FU and leucovorin) chemotherapy in the first-line treatment for patients with unresectable,     recurrent, or metastatic gastric cancer.   "
212382|NCT00632281|"     The purpose of this research study is to determine if Stereotactic Body Radiation     Therapy(SBRT) is a good way to treat tumors near the thorax. Stereotactic Body Radiation     Therapy (SBRT) is a general term for a group of techniques that are designed to deliver     radiation therapy in a way that damages normal tissues less than conventional radiotherapy.     The two features that distinguish SBRT from conventional therapy are procedures that decrease     errors in patient positioning and technology that results in a radiation dose distribution     that conforms more tightly to the tumor target. Patients will receive either 48 Gy or 60 Gy     fractions depending on the type of tumor. The majority of patients will be treated in 1 week,     Monday through Friday, with Wednesday off.   "
212383|NCT00632294|"     Primary Objectives:        1. To evaluate the material properties, histomorphometric indices, bone mineral density          (BMD), and presence of microfractures in retrieved large allograft cortical bone          specimens removed from orthopaedic oncology patients.        2. To correlate physical properties to patient demographics and medical treatment received.   "
212384|NCT00632307|"     Recognition of disease specific clusters of volatile organic compounds in patients with     different lung diseases, using breath analysis with ion mobility spectrometry. Lung diseases     of interest are:        -  COPD        -  tumors        -  airway infection        -  interstitial lung disease        -  sleep apnea Hypothesis: Breath analysis with ion mobility spectrometry can differentiate          pulmonary disorders.   "
212385|NCT00632320|"     To compare the rapid shallow breathing index (RSBI) values, the incidence of adverse     reactions, and the predictive accuracy measured under 5 different ventilator strategies in     the same patient group.   "
212386|NCT00632333|"     The purpose of this study is to evaluate the safety and immune response of multiple peptides     (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 in combination with     chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable,     advanced or recurrent esophageal cancer.   "
212387|NCT00632346|"     The purpose of this study is to determine if there is an association between a variety of     adverse childhood experiences and overweight and obesity. The adverse childhood experiences     that will be examined include childhood abuse (physical, emotional, sexual), childhood     neglect (physical, emotional), and household dysfunction (domestic violence, parental marital     discord, and household members with a history of substance abuse, mental illness, and     criminal behavior). Because this study will be performed at a military treatment facility,     additional military unique experiences to include frequent residential mobility and parental     deployment will also be examined.      Hypotheses/Research Questions: Overweight and obese young adults are more likely to report     having experienced adverse childhood experiences and household dysfunction than their peers     of normal weight. In addition, the more severely overweight or obese the patient, the more     likely the patient is to report a higher number of previous adverse childhood experiences.     Thus, there is a graded relationship between the severity of overweight/obesity and the     number of adverse childhood experiences.   "
212388|NCT00632359|"     The goal of this clinical research study is to learn if Revlimid (lenalidomide) can help to     reduce the level of leukemia in your body. The safety of this drug will also be studied.   "
212389|NCT00632372|"     The purpose of this study is to collect and analyze electrical measurements, timing, and     signals from a CRT-D device in heart failure patients who either already have an implanted     left atrial pressure sensor or will undergo a simultaneous implantation of a left atrial     pressure sensor and a CRT-D device. These devices may be placed at the same time or     separately (staged procedure) at the discretion of the investigator. A comparison will be     made between the information gathered from the CRT-D system and the information gathered by     the left atrial pressure sensor.   "
212390|NCT00632463|"     RSV infections can develop into serious, life threatening conditions among immunocompromised     patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of     RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients     identified as being infected with RSV in the upper respiratory tract.   "
212391|NCT00632476|"     Women who smoke during their pregnancy place their unborn child at an increased risk of     health problems, including decreased lung function and possible lung diseases later in life.     Preliminary animal research suggests that if vitamin C is taken during pregnancy, nicotine's     harmful effects on the unborn baby's developing lungs may be blocked. This study will     determine the effect that vitamin C has on the lung development and function of babies born     to women who smoke during pregnancy.   "
212392|NCT00632489|"     This single center Phase I dose escalation trial will evaluate the safety, tolerability and     efficacy of LBH589 when combined with capecitabine and lapatinib in three parts. Part 1 will     determine the maximum tolerated doses (MTD) of LBH589 when combined with capecitabine. Parts     2 and 3 will be limited to locally recurrent or metastatic breast cancer patients, ICH 3+     overexpression or FISH amplification documented locally. Part 2 will evaluate the safety of     the MTD of LBH589 determined in Part 1 when paired with lapatinib 1000 mg by mouth (PO)     daily. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer     patients, ICH 3+ overexpression or FISH amplification documented locally. Part 3 will     evaluate the tolerability and effectiveness of the triplet combination, LBH589, capecitabine     and lapatinib in breast cancer patients.   "
212393|NCT00632502|"     4-Week Safety Study in Subjects with Neutrophilic Asthma   "
212394|NCT00632515|"     The goal of this psychosocial research study is to learn about the knowledge, beliefs, and     attitudes that people have toward screening for colorectal cancer. Another goal is to study     how families communicate about colorectal cancer risk and colorectal cancer screening, with     each other and with health care providers.      Objectives:        1. To evaluate psychosocial and external factors influencing colorectal cancer (CRC)          patients' communication with their first-degree relatives (FDRs) about CRC risk and          screening information.           Using measures of knowledge, health beliefs and behavior, family closeness, openness and          motivation to discuss CRC and screening, distress, provider support and background          variables (sociodemographics, access to care, and medical history), we will conduct a          cross-sectional study to evaluate factors influencing CRC patients' communication about          CRC risk and screening information to their FDRs.        2. To evaluate psychosocial and external factors associated with CRC screening behavior          among first-degree relatives of CRC patients.      Using measures of knowledge, health beliefs and behavior, family closeness and subjective     norms, distress, provider interactions, benefits/barriers, and background variables     (race/ethnicity, sociodemographics, access to care, and medical history), we will conduct a     cross-sectional study of FDRs of CRC patients recruited under Aim 1 to evaluate factors     associated with CRC screening behavior (specifically, colonoscopy adherence).   "
212395|NCT00632528|"     Children with cerebral palsy commonly undergo multilevel surgery, meaning several lower     limb combined procedures performed during the same surgical intervention. The aim of this     type of surgery is to correct all deformities together in order to restore near to normal     anatomy and muscular function. It is very important to be able to obtain good range of motion     after surgery, in order to consolidate surgical results. During the first days after the     operation, children are sore and it may be difficult to realize adequate physical therapy. In     order to palliate this situation, MEOPA gaz is used during REHAB sessions. Good results have     been obtained so far but no study is available to demonstrate these results. The goal of our     research is to prove that there is a benefit in using MEOPA postoperatively in these     patients.   "
212396|NCT00632541|"     Prior clinical trials involving bevacizumab and sorafenib have demonstrated single agent     activity in previously treated advanced breast cancer. This trial will test combined VEGF     inhibition with sorafenib and bevacizumab in less heavily pre-treated patients with advanced     breast cancer.   "
212397|NCT00632554|"     A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in     the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may     be as effective as 6 months-therapy.   "
212398|NCT00632567|"     Anal incontinence is frequent and treatment is difficult. One of the most important reasons     is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This     incidence is higher after second vaginal delivery, particularly if the first delivery caused     break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean     section. So, do the investigators have to recommend caesarean section for second delivery if     the first was traumatic? But caesarean section had a morbidity. Actually, the choice between     the delivery modalities is very subjective.   "
212399|NCT00632580|"     The purpose of this study is to evaluate the optimal site for application of local     anesthetics in total knee arthroplasty surgery. The hypothesis is, that improved pain relief     is obtained when administering local anesthetics in the tissues sourrounding the knee joint     compared to the knee joint itself.   "
212400|NCT00632593|"     The purpose of this study is to define and evaluate the early complications between two     different surgical techniques used to perform a laparoscopic gastric bypass   "
212424|NCT00632905|"     Prostate Cancer patients treated with LHRH agonists (e.g., goserelin) lose Bone Mineral     Density (BMD). Using a prospective, observational study design, we propose that monitoring     how physicians manage Cancer Treatment Induced Bone Loss(CTIBL) in their patients. The gold     standard for evaluating BMD is dual energy x-ray absorptiometry (DEXA). The proposed study     will provide some of the first prospective data on the rates of Skeletal Related Events     (SREs) in prostate cancer patients undergoing ADT and help develop official guidelines on the     use of DEXA screening for prostate cancer patients.   "
212401|NCT00632606|"     The study will compare effectiveness of intravenous magnesium sulfate to that of intravenous     metoclopramide (Reglan®) for acute headache in pregnant women. We will randomize pregnant     women who present to our emergency department with chief complaint of headache to magnesium     sulfate 2 grams intravenously or metoclopramide 10 mg intravenously; both groups will receive     acetaminophen (Tylenol®) 1 gram orally and normal saline 1 liter intravenously. Headaches are     common during pregnancy, related to hormonal changes, altered sleep patterns and psychosocial     stressors. Common medications for headache such as non-steroidal antiinflammatories or     triptans are typically avoided during pregnancy due to concern for fetal effects. Women, and     their physicians, are often uncertain regarding available medication options with justifiable     safety profiles during pregnancy.   "
212402|NCT00632619|"     This study will evaluate the effectiveness of an integrative group psychosocial therapy     combined with stimulant medication in treating children with attention deficit hyperactivity     disorder plus impairments in mood.   "
212403|NCT00632632|"     This study proposes to evaluate the effects of D-cycloserine (DCS) combined with Virtual     Reality exposure therapy in a sample of patients who developed posttraumatic stress disorder     (PTSD) following either the events of September 11, 2001, or military service in the war in     Iraq. In addition, this study hopes to determine whether a common human genetic single     nucleotide polymorphism (SNP) in a growth factor, brain derived neurotrophic factor, BDNF     (Val66Met), predicts treatment response to PTSD.      Overall, this study aims 1) to determine if subjects administered DCS show a significantly     larger decrease in symptoms of PTSD as compared to those administered a placebo, 2) to     determine if subjects administered DCS show a decrease in PTSD symptomatology significantly     earlier (as measured by weeks) than those administered a placebo, 3) to determine if     differences in symptomatology are evident at a 6-month follow-up and indicate long-term     differences between groups, and 4) to determine if the BDNF SNP predicts treatment response.   "
212404|NCT00632645|"     Huntington's disease (HD) is autosomal dominant neurodegenerative disease, starting in     average (with high variability) in the fourth decade. The disease progression is classically     characterized by a cognitive deterioration (cortical-frontal dementia), motor disorders     (associating chorea, dystonia and bradykinesia), psychiatric disturbances (combining     depression and irritability) and metabolic disorder (cachexia). The disease is fatal within     15 to 20 years in most patients. HD has no cure. Neuroleptics are the main drug used and the     only to demonstrate its efficacy on chorea in clinical trials. But neuroleptics have also     beneficial and adverse effects on other disease characteristics (motor, psychiatric,     cognitive or metabolic). Their profile between beneficial and adverse effects could be     different according the neuroleptics and their classification. The aim of this study is to     compare beneficial and adverse effects of 3 different neuroleptics in HD.   "
212405|NCT00632658|"     Chronic Graft-versus-Host Disease (cGVHD) is an important cause of morbidity and mortality in     patients undergoing allogeneic bone marrow transplantation. cGVHD usually occurs after 100     days following transplantation and develops in 20-60% of transplant recipients. The incidence     of cGVHD varies depending on the age of the marrow recipient, the use of sibling or unrealted     donor bone marrow, teh use of unmanipulated T cell-depleted bone marrow, and perhaps other     factors. Clinically, cGVHD is characterized by multi-system disease, which frequently mimics     the clinical features of autoimmune diseases. The manifestations include skin changes     (lichenoid and sclerodermatous changes, changes in pigmentation, loss of accessory structures     such as hair, dystrophic nails, and rash), joint contractures, severe cramping, hepatic     dysfunctions, sicca syndrome, obstructive lung disease, esophageal dysmotility, weight loss,     polyserositis, immunodeficiency, and autoantibodies including anti-nuclear antibody,     anti-erythrocyte antibodies, and anti-platelet antibodies.   "
212406|NCT00632671|"     The objective of the project is the constitution of a population-based cohort of 500 persons     with severe or morbid obesity (BMI over 35 kg/m2) with annual follow-up for 10 years. It aims     to improve the physiopathological, epidemiological and prognostic knowledge of obesity and     its consequences. Clinical data, biological material, exams and questionaires will be     collected and stored, allowing the realisation of research works, initiated by research teams     from our hospital or from other settings.   "
212409|NCT00632710|"     The purpose of the present study was to assess the effectiveness of low-level laser therapy     on the reduction in pain and improvement in function in the hands of patients with rheumatoid     arthritis   "
212410|NCT00632723|"     This is a phase II trial to assess whether IRESSA™ (gefitinib) has anti-tumour efficacy in     patients with breast cancer. The trial proposes to enter 27 patients who have acquired     resistance to tamoxifen and 27 patients with ER negative tumours. However for each of these     two types of patients recruitment will stop after 14 patients have been entered in order to     confirm that IRESSA™ (gefitinib)has anti-tumour efficacy. If no patient out of 14 in a group     has shown clinical benefit (ie an objective response (CR or PR) or stable disease (SD) for at     least 24 weeks) then a clinical benefit rate of >20% can be ruled out with >95% certainty. If     one or more of the objective response or stable disease (> 24 weeks) has been seen in the     first 14 patients recruited in a group then recruitment to that group will recommence to a     total of 27 patients. If 14 patients are entered into an arm but not all 14 patients are     available for final analysis and the toxicity/safety and tolerability profile of the therapy     is acceptable and documented and a clinical benefit is seen in the patients, enrolment of     additional patients beyond the initial 14 may be made based on overall clinical assessment.   "
212411|NCT00632736|"     To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with     early and advanced Parkinson's disease   "
212412|NCT00632749|"     Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in     combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML)     patients   "
212426|NCT00632931|"     A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval     in patients with relapsed or refractory advanced cancer.   "
212413|NCT00632762|"     This is a French national trial, conducted using a double-blind, placebo-controlled,     randomised design involving 7 centers and 80 patients of both sexes.      The primary objective of the trial is to evaluate the effects of the interruption of a long     term treatment (ex. Greater than 6 months) with Amantadine (prescribed as an antidyskinetic)     in patients suffering from Parkinson disease being treated with Levodopa and suffering from     mid dose dyskinesias.      Secondary objectives of the trial are the evaluation of the other effects of withdrawal of     Amantadine on the same group of patients: motor fluctuations, vigilance, apathy, fatigue,     certain cognitive aspects, the disappearance or development of undesirable side effects and     quality of life.   "
212414|NCT00632775|"     The primary objective of this study is to compare the mean serum sodium at 48 hours following     the initiation of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in     children requiring maintenance IV fluid administration.   "
212415|NCT00632788|"     This study was designed to investigate the influence of the acute myocardial infarction     checklist on the door-to-balloon time in patients suffering from acute STEMI at Far Eastern     Memorial Hospital   "
212416|NCT00632801|"     The incidence of ileus after laparoscopic colectomy continues to pose complications for the     patient, staff, and the healthcare system. Postoperative ileus remains a source of morbidity     and a major determinant of length of stay after abdominal surgery. Clinicians have devised     strategies that minimize postoperative ileus. Gum chewing, an inexpensive intervention, is     theorized to activate the cephalic- vagal reflex and increase the production of     gastrointestinal hormones associated with bowel motility. Four studies examining gum chewing     as an intervention to prevent ileus were found. These relatively few studies have     demonstrated inconsistencies. Because of the small sample size of the four studies and the     inconsistencies of the results, there is not enough evidence to change practice. There are no     indications of risks associated with gum chewing as an adjunct therapy along with standard     postoperative interventions. The purpose of this prospective, randomized control study is to     examine if chewing gum in adult patients after elective laparoscopic colectomy decreases     ileus compared with standard post-operative care.      Patients will be randomized by weeks admitted and the patients in the gum chewing group     (intervention group) will chew one stick of gum the first post-operative day, after the     nasogastric tube is removed or if they patient does not have a nasogastric tube, with the     head of bed elevated a minimum of 30 degrees for 30 minutes, three times a day at set     intervals: 0900, 1400, and 2100. The gum will be kept in the Accudose cabinet and distributed     by the medication nurse. The gum chewing regimen will continue until the first bowel     movement. All patients in the non-intervention group will receive standard preoperative and     postoperative regimens.      Patient demographics that will be collected include gender, age, current medical condition,     pre-operative medications, type of surgery, operative duration in minutes, anesthesia     duration in minutes, estimated operative blood loss, whether they had an epidural or a PCA,     date and time nasogastric tube was discontinued, length of stay, date of discharge,     complications, and whether or not they had an ileus. Patients (if appropriate) and nurses     will be instructed on how to complete the bedside bowel record to the nearest hour.   "
212417|NCT00632814|"     A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on     bleeding events frequency and development of arthropathy in Previously Treated and Minimally     treated Hemophilia A pediatric population.   "
212418|NCT00632827|"     This study examines the use of denileukin diftitox (Ontak) for patients with peripheral     T-cell lymphoma who are candidates for autologous stem cell transplants.   "
212419|NCT00632840|"     The purpose of this study is to determine whether atorvastatin and fenofibrate are effective     in the treatment of lipid disorders in obese, insulin resistant subjects.   "
212420|NCT00632853|"     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,     such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet     known which radiation therapy regimen is more effective when given together with chemotherapy     in treating patients with limited-stage small cell lung cancer. This randomized phase III     trial is comparing different chest radiation therapy regimens to see how well they work in     treating patients with limited-stage small cell lung cancer.   "
212421|NCT00632866|"     Primary Sjögren's syndrome (SJp) affects 0.1% of the population. This systemic autoimmune     disease systemic is characterized by disabling dryness, fatigue and pain, and systemic     complications in 30% of patients. No treatment has proven effective in this disease. In open     studies, some efficacy was observed with hydroxychloroquine but no RCT versus placebo has     ever been done.      Thus, the primary purpose of this study is to evaluate the efficacy and safety of     hydroxychloroquine (400mg/ day) on dryness, pain, and fatigue, assessed by the patient using     visual analogical scales.   "
212465|NCT00633451|"     The purpose of this randomized double-blind clinical trial is to determine the effectiveness     of manual therapy for patients with subacromial impingement syndrome of the shoulder. We     hypothesize that a combination of therapeutic exercise and manual therapy to the shoulder and     spine will be more effective in reducing pain and shoulder disability at short-term (6 wk)     and long-term (3, 6, 12 months) as compared to therapeutic exercise only.   "
212422|NCT00632879|"     Metabolic syndrome (MS), comprised of central obesity, glucose intolerance, hyperinsulinemia,     low HDL-cholesterol (HDL-C), high triglyceride (TG) and hypertension, results in markedly     increased risk for cardiovascular disease in the general population. The National Cholesterol     Education Program Adult Treatment Panel III (NCEP ATP III) report recommended the use of five     variables for the diagnosis of the MS including waist circumference (WC), serum TG     concentration, serum HDL-C concentration, blood pressure and fasting glucose concentration. A     waist circumference of 80 cm in women and 90 cm in men would better identify those with the     MS in Asian populations. However, the studies of modified asian criteria of metabolic     syndrome in hemodialysis (HD) patients are scarce.      We will perform prevalence investigation, cross-sectional study, and prospective     investigation for metabolic syndrome in our HD patients (around 360 at present). We will     enroll all the patients who receive maintenance HD more than three months in our HD center.     The patients who are hospitalizing, suffered from active malignancy, active infections,     recent cardiovascular events and surgery will be excluded in the beginning of study.     Biochemistry and anthropometric parameters including HDL-C, TG, insulin resistance index,     high sensitivity C-reactive protein and WC will be collected and analyzed. We will also     prospectively establish the mortality and hospitalization indices of these patients, to study     the prognosis of HD patient with or without metabolic syndrome.      This study will be helpful to understand whether the application of a modified criteria of     metabolic syndrome in HD patients is capable to predict cardiovascular events,     hospitalization and mortality rates.   "
212423|NCT00632892|"     Clinically, iodinated contrast-medium (CM) is widely used in angiography and computerized     tomography. CM-induced nephropathy (CMIN) is one major complication after application of CM.     Therefore, how to prevent CMIN is always one of the hot topics concerned by nephrologists,     cardiologists, and radiologists.      The present study is aimed to determine the norepinephrine concentration, oxidative markers,     and tubular damage markers in the urine samples of patients undergoing intravenous     pyelography (IVP).      The working hypothesis is high-osmolarity contrast media (HOCM) causes more oxidative stress     and greater tubular damage than iso-osmolarity contrast media (IOCM).   "
239447|NCT00982631|"     A study to examine the combination of temsirolimus and Caelyx® (chemotherapeutic) in advanced     or recurrent breast, endometrial and ovarian cancer.   "
212427|NCT00632944|"     The purpose of this study is to determine the effects of hourly rounding on patient falls,     patient satisfaction, and patient call light usage. This is a replication of research which     determined that hourly rounds conducted by nursing personnel decreased patient falls and call     light usage and increased patient satisfaction. The study design is quasi- experimental. One     unit will be used as its own control (4S). On this unit, hourly nursing rounds will be     implemented by Registered Nurses, Licensed Practical Nurses, and Nursing Assistants. A second     unit, 6S, will maintain current practices and data from this unit will be used to determine     if there are any hospital-wide fluctuations for fall rates, patient satisfaction, or call     light usage. Data for patient falls, patient satisfaction, call light usage, and reasons for     call light use will be collected on both units using fall rate reports, patient satisfaction     survey data, and the call light system.      Falls among hospital patients are a persistent problem, with 2.3 to 7 falls occurring in U.S.     hospitals every 1000 patient days. Approximately 30-48% percent of these falls result in     injury and 5 to 10 percent of them result in serious injury. Fall related deaths occurred at     a rate of 46.2 per 100,000 in 2003. Hospital falls affect both young and old patients and     many of them occur when the patient is alone or involved in elimination-related activities.     Falls that result in injury may lead to an extended hospitalization and increased costs.     Patients who fall and sustain injury are reported to have hospital charges of more than     $4,200 higher than patients who do not fall. Hourly nursing rounds have been shown to     decrease falls by 52%.      Hospitalized patients often require assistance with basic self-care tasks, such as using the     toilet, ambulating, and eating; they ask for assistance by using the call light. Therefore, a     patient's level of satisfaction with nursing care depends principally upon the patient's     perception of how well the nursing staff has been able to meet his or her needs. The call     light can be a lifeline for hospitalized patients, but it can also impose considerable     demands on nurses' time. Several studies have documented the unfavorable effects of patients'     frequent use of call lights on the effectiveness of patient-care management on inpatient     units, which may already be compromised by staffing shortages.   "
212428|NCT00632957|"     The purpose of this study is to test the hypothesis that dietary n-3 PUFA will have a     beneficial effect on systemic and local markers of inflammation when combined with     traditional, non-surgical periodontal therapy.   "
212429|NCT00632970|"     This program is designed to study the efficacy, safety, lipid effects and tolerability of     raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not     received prior antiretroviral therapy. All patients will receive concomitant therapy with     Truvada.   "
212430|NCT00632983|"     RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy     uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor     may not need treatment until it progresses. In this case, active surveillance may be     sufficient. It is not yet known which treatment regimen is more effective for localized     prostate cancer.      PURPOSE: This randomized phase III trial is studying active surveillance to see how well it     works compared with radical prostatectomy or radiation therapy in treating patients with     localized prostate cancer.   "
212431|NCT00632996|"     The purposes of this study are to:        1. determine if a rehabilitation program that consists of exercise and manual therapy          reduces pain and improves quality of life in patients with shoulder subacromial          impingement syndrome;        2. determine which patients are likely to respond to this rehabilitation program and which          patients are not likely to respond to this rehabilitation program      The hypotheses are:        1. the rehabilitation treatment program will result in significant changes in pain and          quality of life        2. there will be items from the history and examination that will identify those patients          who respond favorably and those who do not respond favorably to rehabilitation at 6          weeks, 3, 6 and 12 months.   "
212432|NCT00633009|"     The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of     the product. This study has been designed to measure the skin test responses to 15, 30, or     50µg doses of LtSTA. The measurements of non-specific reactivity due to components of the     antigen solution and the product's ability to sensitize lymphocytes of Leishmania naïve     persons when administered intradermally. The presence or absence of a local inflammatory     response to the first skin test with each of three doses of LtSTA will provide insight on the     specificity of the antigen in a naïve population. The local inflammatory response to LtSTA     following the first and second repeat skin tests will indicate if the antigen is sensitizing     after intradermal administration.   "
212433|NCT00633022|"     This study is being conducted to assess the potential anti-inflammatory effects of a 3-month     treatment with GW856553, on the inflammatory activity within the aorta and carotid plaques,     as assessed by FDG-PET/CT.   "
213104|NCT00640679|"     The hypothesis to be tested is that gradual clopidogrel therapy cessation is associated with     a superior clinical outcome compared with abrupt cessation (superiority hypothesis).   "
212434|NCT00633035|"     Although stress ulcer is a complication that can cause mortality and morbidity in critical     patients, there is still lack of consensus about its prophylaxis. There is also few data     available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer     sucralfate (a mucosal protective agent) for the sake of less associated nosocomial pneumonia.     Recently, proton pump inhibitors were shown to have good prophylactic effects for stress     ulcer. Esomeprazole, an isoform of omeprazole, has good acid suppression effect and the     tablets are soluble for the use of tube feeding. Our previous study showed that there was no     difference for the efficacy of stress ulcer prophylaxis between esomeprazole and sucralfate     in patients admitted to medical ICU with at least one risk factor. The prevalence of     nosocomial pneumonia was also similar.      We will enroll those patients that have received intracranial surgery and admitted to     neurosurgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7     days within 24 hours. They are randomly allocated to 2 groups. Group I: esomeprazole 40 mg qd     from NG route or orally; Group II: famotidine 20 mg iv bolus q12h. We will monitor the     following data: Glasgow coma scale, APACHE II score, CBC, CXR, stool character and OB test,     NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopy will be performed. We     define the end point as overt bleeding, death or transfer out of ICU. We will compare the     prevalence of UGI bleeding and nosocomial pneumonia in these 2 groups.   "
212435|NCT00633048|"     This is the first time that NSA-789, a new compound being developed for schizophrenia, will     be given to humans. Each healthy subject will receive a single dose, except for 8 subjects     who will receive 2 doses-- one dose under fasting conditions and one dose after eating food.   "
212436|NCT00633061|"     The primary hypothesis of this study is that occult catheter-related DVT in children with     cancer is common and directly contributes to development of serious catheter complications,     specifically bacteremia/fungemia and/or recurrent occlusion of the catheter tip. Accordingly,     anticoagulant treatment of clinically silent (occult) DVT will reduce rates of     catheter-related infection and occlusion, delays in therapy and need for catheter     replacement.   "
212437|NCT00633074|"     The purpose of this study is to show the non-inferiority of different formulations of     GlaxoSmithKline Biologicials' influenza vaccine.   "
212596|NCT00626379|"     Heart disease is the leading cause of death in the United States and is responsible for 30%     of all deaths in the United States. This study will examine how risk factors for heart     disease in young and middle aged people affect people's health as they grow older.   "
212438|NCT00633087|"     Subjects will be asked to participate in this clinical trial to examine the safety of     2-deoxyglucose (an agent which is quite similar to glucose) in the treatment of solid tumors     and hormone refractory prostate cancer. This agent works by blocking the metabolism of     glucose in the cells of the body. Although all cells require glucose for metabolism, it is     believed that cancer cells require significantly more glucose than normal cells to grow.     Therefore, even slight effects of glucose metabolism in cancer cells might result in the     shrinkage of certain cancers. This agent has been given to humans before and has only caused     mild nausea, vomiting and glucopenia (low blood sugar) at the doses given in these studies.     This study will further examine the safety of 2-deoxyglucose in the treatment of advanced     solid tumors and hormone refractory prostate cancer. The information obtained in this study     will be used to design future clinical studies with 2-deoxyglucose. Subjects will be asked to     take an oral solution of 2-deoxyglucose daily, by mouth, while on this study. They will be     asked to have CT Scans, Bone Scans, and optional PET (Positron Emission Tomography) Scans     prior to starting this study. PET scans will also be performed shortly after the start of the     study and after 2 cycles (6 weeks) of therapy. Subjects will be asked to have a comprehensive     physical examination and blood work prior to the start of the study. During the first 2     cycles of the study subjects will be asked to have blood drawn at different time intervals     for the first 2 days of each cycle. While on the study, they will be asked to return to the     clinic at intervals of 1 week for a physical examination and blood tests. Subjects will also     be asked to have CT Scans and Bone Scans at intervals of 9 weeks while on the study.   "
212439|NCT00633113|"     The purpose of this study is to evaluate and compare the clinical, radiographic (x-ray) and     cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally     invasive knee joint replacement surgical techniques. The primary study hypothesis is that in     comparing total knee replacement performed with the two different surgical techniques that     respect four minimally invasive surgery principles (low-profile instrumentation, minimally     invasive incision, overall minimal knee surgical intervention), a faster return to function     will result when the technique does not incise the tendon.   "
212440|NCT00633126|"     The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric     subjects   "
212441|NCT00633139|"     This is a single center, open-label study of patients with late infantile MLD. All patients     were previous treated 26 weeks in the phase I trial (EudraCT number: 2006-005341-11,     NCT00418561). All patients will be offered continuing treatment in this study and will in     this protocol receive 13 infusions, whereby the patients total have had 27 infusions of     Metazym. One infusion will be given every other week. After a total of 52 weeks of treatment     the subjects will continue treatment in a compassionate use protocol. Safety (AE/SAE) will be     monitored at every visit.   "
212442|NCT00633152|"     The purpose of this study is to determine whether ceftaroline is effective and safe in the     treatment of complicated skin and skin structure infections in adults.   "
212443|NCT00633165|"     This is a Phase II, multicenter, open-label clinical trial designed to determine the efficacy     and safety of Brostallicin when administered once every 3 weeks in patients with myxoid     liposarcoma with (12;16) translocation. The primary objective of this study is to determine     the response rate following Brostallicin administration.   "
212444|NCT00633178|"     This study will evaluate the effectiveness of group interpersonal psychotherapy for     preventing postpartum depression in pregnant women with depression and for improving healthy     outcomes in their babies.   "
212445|NCT00633191|"     Hypothesis: Daily gargling with specific avian antibodies against Pseudomonas aeruginosa will     prevent infections with this bacteria in patients with Cystic fibrosis (CF).   "
212446|NCT00633204|"     The purpose of this study is to evaluate the clinical efficacy for the prevention of the     recurrence for bladder cancer after TUR-Bt   "
212447|NCT00633217|"     The purpose of this study is to evaluate the efficacy and safety of the FSC HFA MDI in     subjects with COPD. The dose of FSC HFA MDI to be evaluated corresponds to the dose of FSC     DISKUS (250/50mcg twice-daily) that is indicated for the treatment of COPD associated with     chronic bronchitis in the US. This study will last up to approximately 15 weeks, and subjects     will visit the clinic 5 times. Subjects will be given breathing tests and will record their     peak expiratory flow measurements daily on diary cards. All study related medicines and     medical examinations will be provided at no cost. The FSC HFA MDI used in this study has been     approved by FDA for use in asthma while the FSC 250/50mcg DISKUS has been approved for use in     asthma and COPD.   "
212448|NCT00633230|"     The purpose of this study is to (1) determine the effects of the herbal formula Sho-saiko-to     (SST) compared to placebo in treating hepatitis C virus (HCV) in persons who have not     responded to the current conventional therapy (peginterferon alfa and ribavirin) or who have     relapsed or in those for whom conventional therapy is contraindicated; (2) determine the     influence that SST will have on participant reports of depression/sadness, fear and     uncertainty related to the HCV disease progression, and renewal of hope in these individuals;     and (3) collect preliminary data needed to examine feasibility, patient acceptance, and any     potential limitations of the study.   "
212449|NCT00633243|"     We hypothesize that integrating Hepatitis C into methadone and buprenorphine treatment will     improve Hepatitis C outcomes as well as drug treatment outcomes in patients who are addicted     to opiates. We will test this hypothesis by randomly assigning patients to receive integrated     or separated care. The first group will receive Hepatitis C treatment and substance abuse     treatment contemporaneously at the South Central Rehabilitation Center (SCRC). They will take     both methadone or buprenorphine and Hepatitis C medications under the daily (methadone) or     weekly (buprenorphine) observation of a health care provider. The second group will receive     substance abuse treatment at SCRC, and go to another facility to receive Hepatitis C     treatment services. These participants will take their medications on their own (without     observation).      We will look at outcomes such as Hepatitis C viral loads, adherence to medications, and drug     treatment outcomes such as receipt of buprenorphine and methadone and urine toxicology     testing.   "
212488|NCT00633750|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with     breast cancer that can be removed by surgery.   "
212450|NCT00633256|"     A total of 20 subjects will participate in this four week, between groups, double-blind,     placebo controlled study. Subjects will participate in two experimental sessions separated by     approximately one week. Subjects will be randomized to receive either 50 mg cycloserine or     placebo combined with cue exposure. Several physiological and subjective outcome measures     (e.g., heart rate, blood pressure, galvanic skin response) will be obtained during the     sessions. Experimental sessions will last approximately 4.5 hours with follow-up sessions     lasting approximately thirty minutes. Our aims are:        1. To examine the effect of cycloserine vs. placebo on extinction of smoking cue reactivity          in overnight abstinent smokers. Reactivity to smoking cues will be captured with          self-report smoking urges and physiological measures (heart rate, blood pressure, and          skin conductance).           We hypothesize that cycloserine, relative to placebo, will facilitate extinction of          smoking cue reactivity.        2. To examine the effect of cycloserine vs. placebo when combined with two 4.5 hour          laboratory cue exposure training sessions, on smoking behavior in smokers. Smoking          behavior will be measured with self-report smoking and saliva cotinine levels.        3. To examine the effect of cycloserine vs. placebo on memory performance in nicotine          dependent smokers. Memory performance will be measured with verbal learning, recognition          and recall tasks.      4) To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize     that cycloserine will be well tolerated by smokers.   "
212451|NCT00633269|"     Open, non-randomized, radiolabelled, single centre study designed to characterize the     metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg     [14C]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid     tumours.   "
212452|NCT00633282|"     The purpose of this study is to evaluate the effects and safety of pioglitazone and berberine     on the basis of lifestyle intervention to non-alcoholic fatty liver disease patients with     impaired glucose regulation or type 2 diabetes mellitus.   "
212453|NCT00633295|"     The mainstay of therapy for GISTs is surgical resection, however, recurrence is almost     inevitable in high-risk tumors and secondary surgery or other salvage therapy has yielded     poor outcome. The median survival for patients with unresectable or metastatic GIST is     approximately 20 months, and for patients with local recurrence it is 9 to 12 months.     Responses to chemotherapy have been at best 5%. The introduction of imatinib has dramatically     changed the prognosis of these patients yielding response rates between 41% and 71% and an     overall clinical benefit (tumor responses plus stable disease) ranging between 73% and 90%.      However, resistance to imatinib may develop and represents a further clinical challenge.     Sunitinib has recently been approved by the FDA for patients whose disease has progressed or     who are intolerant to imatinib therapy. Patients with tumor progressing on sunitinib or     another 2nd line agent have limited therapeutic alternatives. Reinstitution of imatinib, if     possible, is considered an acceptable option for these patients because it may slow the rate     of disease progression even in the setting of prior imatinib failure; however a more optimal     3rd line treatment is needed. AMN107 is a novel aminopyrimidine, available as an oral     formulation that is ATP -competitive inhibitor of BCR-ABL,more potent than Imatinib. It     inhibits proliferation and autophosphorylation of 32 out of 33 BCR-ABL point mutations. In     addition AMN107 also inhibits PDGFRα,PDGFRβ, and KIT. Preliminary data from an ongoing Phase     I study in imatinib-resistant GIST patients (CAMN107A2103) indicate that AMN107 alone (400 mg     BID) and in combination with imatinib (imatinib 400 mg BID plus AMN107 200 mg QD and 400 mg     QD) is well tolerated in this pre-treated patients.   "
212454|NCT00633308|"     The purpose of this sudy is to determined the effect of dialysate volume and treatment time     on phosphate and calcium removal in stage V chronickidney disease patients treated by     hemodialysis using the System One (NxStage Medical, Lawrence, MA)   "
213114|NCT00640809|"     To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen     plus omeprazole   "
212455|NCT00633321|"     Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually     from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of     cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers;     but for smokers who can quit there is an immediate and significant beneficial impact on their     health and life expectancy. Cigarette smoking remains the leading preventable cause of death     in the United States (US), accounting for approximately 1 of every 5 deaths (438,000 people)     each year.      This Phase 2 study will investigate the efficacy and tolerability of 2 doses of TA-NIC     compared to placebo as an aid to smoking cessation in smokers who are motivated to quit.   "
212456|NCT00633334|"     Therapies involving the immune system have already shown great promise in early clinical     trials for the treatment of renal cell carcinoma and melanoma. One of the great challenges     now facing this field is to extend these findings to other cancers. Little is currently     understood about the nature of the immune response to more common gastrointestinal cancers.     The first goal of this proposal is to collect blood and tissue samples from patients with     early or late stage gastrointestinal cancers. These samples will be evaluated to better     understand the immune response to these two cancers. The second goal of this proposal is to     evaluate the specimens of these patients for changes and genetic markers that correlate with     the presence of cancer. The information gathered from these studies will directly enhance our     ability to design, conduct and monitor novel immunotherapeutic protocols for the treatment of     patients with gastrointestinal cancer.   "
212470|NCT00633516|"     The incidence of malignant melanoma has increased dramatically in recent decades. In 1930,     the lifetime risk of an individual in the United States developing melanoma was 1 in 1,500.     This has been exponentially increasing over the years with the risk estimated to be 1 in 75     in 2000 . According to the American Cancer Society, approximately 59,580 new cases of     melanoma will be diagnosed in the United States in 2005 and about 7,770 people are expected     to die of the disease.   "
212471|NCT00633529|"     To evaluate the safety of the proposed Phase II dosage of the investigational drug IMO 2055     when combined with erlotinib and bevacizumab in patients with previously treated advanced     NSCLC.   "
212472|NCT00633542|"     This is randomized, multicentre study aimed to compare a standard maintenance therapy with     Interferon-Dexamethasone with an experimental therapy based on Thalidomide-Dexamethasone in     patients with multiple myeloma who responded to ThaDD induction therapy   "
212597|NCT00626392|"     The primary purpose of this study was to assess the effect of aspirin (ASA) on niacin     extended-release (NER)-induced flushing in subjects with dyslipidemia.   "
212457|NCT00633347|"     Oocyte donation is a well established procedure in assisted reproduction treatments (ART). It     is demonstrated that the use of hormonal substitution therapy, for the synchronization of the     cycles between the recipients and the donors, provides good results, similar to the ones     obtained with the natural cycle. In the patients - recipients with preserved ovarian     function, the recipient's natural cycle is annulled, thus preventing the spontaneous     Luteinizing Hormone surge. Simultaneously and while waiting for the suitable donor, her     endometrium is prepared. When the donation occurs and fertilization with the husband sperm     takes place, her cycle is stimulated again in order to synchronize her window of implantation     with the donor's ovulation.      Two different medications are commonly used to inhibit spontaneous ovulation: either GnRHa     agonist or GnRH antagonists. The present study consists of the comparison between the single     dose GnRH agonist (Decapeptyl 3,75 IM) and the 7 day dosage of GnRH antagonist (Cetrotide     0,25 mg). The administration of GnRHa is used fundamentally as a long liberation formulation,     administered in a single intramuscular injection (IM), which is more practical in terms of     use. Nevertheless, the unnecessary persistence and the potentially unfavorable action of     GnRHa during the luteal phase and early gestation have questioned its use. The recovery of     the Hypophysarian function begins only 8 weeks after the single injection of long liberation     of triptorelina 3.75 mg. The GnRH antagonist (Cetrotide 0,25 mg) makes the hypofisary     inhibition shorter than with the analogues and can prepare similar endometrium     characteristics as a natural cycle. The recipients will be assigned randomly to a group of     treatment or another.   "
212458|NCT00633360|"     To determine if augmentation with the oral-contraceptive pill containing drospirenone and     ethinyl estradiol is more effective than placebo in the treatment of premenstrual     breakthrough of depression.   "
212459|NCT00633373|"     Currently there are no approved therapies for lung transplant recipients in the United States     (US). Treatment with CIS following lung transplantation has previously been demonstrated to     result in a clinically meaningful improvement in survival and chronic rejection-free survival     compared to placebo, but additional data supporting its use is needed prior to Food and Drug     Administration (FDA) approval. This treatment use protocol is a mechanism for providing     eligible lung transplant recipients early access to CIS in advance of FDA approval.   "
212460|NCT00633386|"     To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients     treated with celecoxib versus placebo.   "
212461|NCT00633399|"     The purpose of this study is to see if adding the study drug, ziprasidone, to an     antidepressant medication helps improve symptoms of Major Depressive Disorder (MDD). We are     studying the drug's effectiveness in treating depression, as well as its safety when it is     added to another drug.      Hypothesis A: There will be a difference in the percentage of responders in the two treatment     conditions during phase 2; response rates will be higher for the ziprasidone group.   "
212462|NCT00633412|"     Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This     study looks at the treatment of these gastric ulcers with one of the three following     treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once     daily; or ranitidine 150 mg twice daily for subjects in the US only.   "
212463|NCT00633425|"     Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2     diabetics inadequately controlled by metformin, before and after the addition of Glimepiride.   "
212464|NCT00633438|"     To compare total analgesic use at 24 hours after arthroscopic knee surgery in     celecoxib-treated versus placebo-treated patients   "
212520|NCT00634179|"     This is an open-label (doctors and patients know which drug will be given), single center,     phase 1/2 clinical trial. The primary objective is to determine whether VR-CHOP provides     benefit to patients with previously untreated indolent non-Hodgkin's lymphomas (NHL).   "
212466|NCT00633464|"     The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and     the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with     triple negative (estrogen receptor [ER], progesterone receptor [PR], Human Epidermal Growth     Factor Receptor 2 [HER2] negative) locally advanced non-resectable and/or metastatic breast     cancer   "
212467|NCT00633477|"     The purpose of this study is to determine the effect of resatorvid on subjects with sepsis.   "
212468|NCT00633490|"     Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor     receptor (VEGFR), so it can inhibit tumor angiogenesis. This phase I study aims to determine     the drug's toxicity and to find a dose level to be used in a phase II study in solid tumor     patients.   "
212469|NCT00633503|"     Tissue transfer flaps are a method of moving tissue from a donor location to a recipient     location. In the case of a free tissue transfer flaps, the blood vessels to the transferred     tissues are detached and then re-attached to different arteries & veins at the recipient     site. The process of reconstructive surgery using tissue transfer flaps allows for improved     results in terms of functionality, aesthetic appearance, and psychological well-being in     patients requiring reconstructive surgery after cancer resection or trauma. The process of     reconstructive surgery using tissue transfer flaps is not without complications. These     complications may include acute arterial or venous occlusion, as well as the development of     late complications such as fat necrosis and flap atrophy.      The purpose of this pilot study is to determine if a novel, unique, portable, non-contact     optical imaging device developed at the Beckman Laser Institute called Modulated Imaging (MI)     can detect changes in a flap's optical properties, which can correlate with arterial or     venous occlusion or with the development of fat necrosis or flap atrophy. The study would     also evaluate if changes in the tissue transfer flap's optical properties, as detected by the     device could be employed as a monitoring device in the post-operative period after     reconstructive surgery. The MI device's detection of specific optical properties of a tissue     flap could also potentially be used as a diagnostic tool to predict the likelihood of the     development of fat necrosis or flap atrophy in a delayed fashion several months after     reconstructive surgery.      Prior animal and clinical studies using similar devices have demonstrated that changes in the     total hemoglobin concentration and percentage of oxygenated hemoglobin in the tissue transfer     flap can be used to differentiate between arterial and venous occlusion. These other similar     devices have been shown to be able to detect venous occlusion prior to clinical     manifestations of venous occlusion using standard monitoring methods. This early detection of     venous occlusion has important implications. It is well established that early detection and     surgical re-exploration and correction of venous occlusion is associated with improved     survival and salvage rates of tissue transfer flaps. It has been suggested in the     reconstructive literature that the development of fat necrosis and flap atrophy are caused by     a relative arterial or venous insufficiency, which could be detected using the MI device     prior to the clinical manifestations of these complications.Patients undergoing     reconstructive surgery at UCI Medical Center will be recruited for enrollment into the study.     The study design requires following the patients and review their medical records in order to     determine the clinical outcomes of their reconstructive surgery. The process of review of the     medical record will require the review of both the in-patient medical record during the     hospitalization in which the reconstructive surgery takes place and the outpatient medical     record after surgery in order to observe for the possible development of the acute and     delayed complications of reconstructive surgery.   "
212632|NCT00627068|"     Our main hypothesis is that EPC function is impaired in some populations with high     cardiovascular risk as a result of reduced eNOS-dependent NO production.   "
212473|NCT00633555|"     Patients who have undergone in vitro fertilization (IVF) and produced four or less follicles     or had four or less oocytes (eggs) retrieved are often referred to as poor responders. We     will refer to these patients from this point forward as low responders to avoid using a     potentially offensive label. We are currently using 2 different IVF medication protocols in     our practice to treat low responder patients with infertility: the Microdose Leuprolide     protocol and the Luteal Phase Ganirelix protocol. We would like to conduct a     randomized-controlled trial and randomize patients to one treatment group or the other to     determine which medication protocol is more effective in treating infertility in this group     of patients.   "
212474|NCT00633568|"     The purpose of the present trial is to assess if induction concurrent chemoradiotherapy     followed by consolidation chemotherapy will improve survival in comparison with the same     chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.   "
212475|NCT00633581|"     Fatigue is one of the most frequently observed symptoms for company workers, and oxidative     stress is regarded as one of its cause. Vitamin C is a well-known antioxidant, and the     investigators seek for evidence of the efficacy of high dose vitamin C parenteral supplement     on fatigue symptoms of company workers after work.   "
212476|NCT00633594|"     This is a Phase I/II multicenter, open-label, dose-escalation study of rituximab, bortezomib,     and lenalidomide in the first-line or second-line treatment of patients with Mantle Cell     Lymphoma (MCL).   "
212477|NCT00633607|"     After informed consent, participants will be asked to complete a medical/family history     questionnaire and provide a blood sample. Participants will also be asked for their     permission for study investigators to access medical records and/or recontact them for     updates to their medical and family histories. Data and biospecimens will be stored for     potential future research projects.   "
212478|NCT00633620|"     Narrow Band Imaging (NBI) with high-definition (HDTV) visualization has been implemented into     GI endoscopy with the purpose to better highlight endoluminal pathological structures by     improving their contrast. Previous studies from referral centers could not show significant     differences in terms of colonoscopic adenoma detection rate, but either very high adenoma     rates or some numerical differences suggested that some benefit may exist which may become     evident with average adenoma rates and/or large case numbers.      In a prospective randomized trial performed exclusively in a multicenter private practice     setting involving 6 examiners with substantial life-time experience (>10.000 colonoscopies)     1200 patients will undergo HDTV screening colonoscopy with either NBI or conventional imaging     technique on instrument withdrawal. Primary outcome measure is the adenoma detection rate     (ADR; i.e. number of adenomas per patient).   "
212479|NCT00633633|"     The goal of this behavioral research study is to learn if education and training about     exercise can help to change the lifestyle of cancer survivors with symptoms of heart failure.   "
212480|NCT00633646|"     Current therapy recommendations suggest a low protein diet to preserve residual renal     function (RRF) before the start of dialysis, but a higher protein intake during dialysis to     prevent protein-energy wasting (PEW). We conducted a randomized trial to test whether low     protein intake also during treatment with peritoneal dialysis (PD) would be safe and     associated with a preserved RRF.   "
212481|NCT00633659|"     The purpose of this study is to evaluate the effects of Hemospan infusion on vascular     reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic     critical lower limb ischemia.   "
212482|NCT00633672|"     Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This     study looks at the treatment of these gastric ulcers with one of the three following     treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine     150 mg twice daily.   "
212588|NCT00626275|"     The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving pain     associated with rheumatoid arthritis (RA) compared with placebo and naproxen (similar to     Aleve®). A second objective is to see whether the effect of ADL5859 differs after a single     dose compared with multiple doses.   "
212483|NCT00633685|"     Three hundred (300) male or female outpatients, over 18 years of age, will be enrolled in     this study to determine whether fluoxetine can be used as a treatment for Posttraumatic     Stress Disorder in soldiers recently returning from combat exposure. There will be two phases     to the study. In Phase I Fluoxetine + usual psychological care will be compared with Placebo     + usual psychological care over a 12-week period. Subsequently, in Phase II all subjects will     be offered the opportunity to enroll in a 20-week open-label trial on Fluoxetine. If response     is inadequate, adjunctive treatment with either buspirone or bupropion will be offered. The     investigational drugs are Fluoxetine, Buspirone and Bupropion. All are commercially     available.   "
212484|NCT00633698|"     Lipoprotein (Lp)(a) has been associated with increased risk of cardiovascular disease. Niacin     has been shown to lower Lp(a) in patients with normal or moderately elevated levels. However,     there are few studies assessing the effectiveness of niacin in Lp(a) levels above 30 mg/dl.     In addition, most studies investigating the effectiveness of niacin have only included small     numbers of patients. Also, Lp(a) was only assessed as a secondary endpoint. The aim of the     present study was, therefore, to evaluate whether Niacin is effective compared to placebo in     the reduction of an elevated Lp(a).   "
212485|NCT00633711|"     The main purpose of this study is to investigate if treatment of obstructive sleep apnea     syndrome (OSAS) by continuous positive airway pressure (CPAP) given by a traditional CPAP     device administering a fixed air pressure, or by one automatic CPAP device (Somnosmart2,     Weinmann, Hamburg) administering variable pressures, have different effects on sympathetic     nervous system tone (as reflected by urinary excretion of norepinephrine and its catabolite     normetanephrine) and on blood pressure.   "
212486|NCT00633724|"     The purpose of this study is to evaluate the safety, tolerability, immune response and     clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, TTK,     VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.   "
212487|NCT00633737|"     The purpose of this study is to investigate whether a stress reduction intervention prior to     surgery can improve wound healing and recovery.The investigators hypothesise that patients     who receive a psychological stress reduction intervention prior to surgery will report lower     stress and higher perceived control, have lower stress hormones, better wound healing and     better self-reported recovery than patients who receive standard care alone.   "
212644|NCT00627237|"     The purpose of this study is to determine the efficacy of an intensive short term cognitive     rehabilitation program aimed towards improving executive functioning in individuals with     traumatic brain injury (TBI).   "
212489|NCT00633763|"     The pancreas is an organ that plays major roles in the digestion of food. A part of the     pancreas called islet beta-cells produces insulin, which regulates the amount of glucose (a     sugar) present in the blood at all times. Type-1 Diabetes Mellitus (T1DM), an autoimmune     disorder characterized by destruction of pancreatic islet beta-cells (the cells that produce     insulin), affects at least a million individuals in the US alone. In T1DM, a type of white     blood cells called T lymphocytes attacks and destroys the pancreatic islet beta-cells,     leading to a loss of insulin, an increase in blood glucose, and a dependence on insulin     injections for survival. Despite rigorous control of blood sugar, the majority of diabetic     patients develop serious complications including retinopathy, nephropathy, neuropathy,     microangiopathy and strokes.      Non-invasive methods to monitor pancreatic beta-cell loss associated with type-1 diabetes     mellitus (T1DM) could improve early diagnosis, provide tools to measure responsiveness to new     therapies, and evaluate the efficiency of pancreatic transplantation and graft survival.      Our goal is to develop a non-invasive PET-CT imaging method based on binding of a molecule     (18F-fallypride) for tracking beta-cell loss during the progression of T1DM. In preliminary     studies we demonstrated specific binding of 18F-fallypride to D2 receptors in rat pancreatic     sections and we demonstrated that the loss of pancreatic beta cells in streptozotocin-treated     rats was associated with a corresponding decrease in 18F-fallypride binding to pancreatic     sections. A preliminary 18F-fallypride PET-CT study done by a collaborator in Ohio on a     healthy volunteer, revealed 18F-fallypride-uptake by the pancreas that was distinguishable     from surrounding tissues. Aim-1 of our project will measure the variability of 18F-fallypride     PET-scanning of the pancreas in six healthy volunteers scanned twice with an interval of 4-6     weeks. In Aim-2 of our project, we will compare fallypride PET-CT scans of 12 patients with     long-standing T1DM (nearly all beta cells destroyed) with 12 age- and sex-matched healthy     volunteers. If we are able to distinguish between the two groups, we will in future (a)     optimize the method so as to be able to detect a 20-30% loss of beta cells, and (b) perform     PET-CT studies in new-onset T1DM patients and in at-risk first degree relatives of T1DM     patients.   "
212490|NCT00633776|"     The purpose of this study is to compare the effects of nebulized formoterol fumarate     (Perforomist) to dry-powder inhaler formoterol fumarate (Foradil). Perforomist is a solution     that is made into very fine spray (using a nebulizer) that is then breathed in over 10-15     minutes. Foradil is taken in a single quick, deep inhalation.   "
212491|NCT00633789|"     The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder     and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on     treatment. Those in which it is unclear will be randomized to continue or withdraw treatment     to determine whether that benefit is related to brivanib   "
212492|NCT00633802|"     Personality disorders are life-long maladaptive behavioral patterns. Borderline personality     disorder (BPD) is the leading personality disorder encountered in clinical settings, often     associated with tremendous distress. It is characterized by impulsivity, emotional lability,     unstable interpersonal relationships, with particular sensitivity to abandonment. BPD     patients are prone to self destructive behaviors and all too frequently attempt suicide. When     in emotional turmoil, persons with BPD may also develop brief, transient psychotic states.      Psychotherapy for BPD is a common treatment option, but it requires considerable time and     specific personnel training, and is therefore not always feasible. Medical treatment is an     efficacious alternative, however there is no concensus on drug selection. Some experts have     suggested that medical treatment should be selected individually according to the subject's     dominant clinical symptom. Several psychopharmacological groups have been proposed:     Antidepressants, mood stabilizers, and several novel antipsychotic drugs. The latter are     particularly promising since they may produce symptomaic improvement with fewer adverse     effects. Risperidone has been shown in a few preliminary studies to be promising in the     treatment of various BPD symptoms, but no controlled study has tested it yet. We propose to     test the efficacy of risperidone in the treatment of BPD in a double-blind crossover design     using both clinical and phsysiological measure.The main hypothesis is that risperidone will     be efficient in alleviating BPD core and secondary symptoms.   "
212516|NCT00634114|"     The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once     daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux     esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily     by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the     treatment period (from the randomisation to the treatment completion) according to the Los     Angeles classification.   "
212493|NCT00633815|"     Fontan-palliated patients comprise an interesting group of single-ventricle patients who are     dependent upon passive return of blood from the body to the lungs. Systemic venous pressures     are therefore quite elevated, and one study demonstrated that venous capacitance was     diminished. In addition, these patients have markedly diminished aerobic capacity (Max VO2).     Although one recent study demonstrated that Fontan patients can increase their Max VO2     through diligent cardiac rehabilitation, their ultimate results were still well below     average.      It has previously been described that normal, healthy subjects have decreased exercise     performance in a supine vs upright position. However, due to high venous pressures and the     need for systemic venous return to overcome gravity in order to perfuse the lungs, one might     hypothesize that Fontan patients would have increased exercise performance in a supine vs     upright position. The investigators are interested in studying this hypothesis.   "
212494|NCT00633828|"     Objective:      Prospective study regulation in bone mass, size, architecture, cortical, trabecular bone,     soft tissues and risk factors for cardiovascular disease at growth. Determine regulation by     environmental factors. Evaluate how training affects the skeleton, soft tissues and     cardiovascular risk factors during growth Material/Methods: (i) 500 children in one RCT´s     with or without intervention with physical activity (daily scholl physical education) from     school start to college. Annual evaluations      Importance:      The investigators provide increased understanding of the pathophysiology of osteoporosis by     determine the mineralization, size- and architecture development during growth and adulthood.     Evaluate if intervention program with exercise increase bone strength, muscle mass and reduce     fatness and risk factor for cardiovascular disease.      Background:      Skeletal growth and the age related bone loss determine who will get osteoporosis (and     fractures), but not only bone mass, also skeletal architecture and bone quality influence     bone strength. Regulation of the traits differs where hormones, genetics and environmental     factors continuously influence the development with different effect during different ages.     It is thus imperative to determine the regulators of the traits and evaluate if these can be     modified during growth.      Aim:      Study regulation of bone mass, size, architecture, cortical, trabecular, axial and     appendicular bone and soft tissue during growth and aging; evaluate risk factors for     cardiovascular disease; determine importance of environmental factors and hereditary factors.      Study Design/Method      Bunkeflo Cohort:      Prospective, controlled exercise intervention study annually following skeletal development     in 500children from age 7.      Importance:      By evaluating skeletal mass/architecture separate we will increase the understanding of the     pathophysiology of osteoporosis. The intervention study provide Evidence Based Information as     regard the importance of physical activity during growth. The presented Strength Index, where     we combine bone mass and skeletal architecture, may predict fractures better than only bone     mass.   "
212495|NCT00633841|"     The purpose of this study is to assess the tolerability and safety of repeated subcutaneous     injection of a single dose of AFFITOPE AD02 in patients with mild to moderate Alzheimer's     Disease.   "
212496|NCT00633854|"     The objective of this research is to improve the care of ocular disease and disorders, in     particular the changes in the eye associated with diabetes, by providing clinicians with     dramatically improved ultrasonic images of the entire eye. The research combines advanced     high-frequency, high-resolution ultrasonic annular arrays transducers with new processing     techniques designed to overcome several limits that have been reached with conventional     high-frequency ultrasound systems. We propose that diagnosis of eye diseases using annular     arrays can be more effective than the conventional ultrasound images by at least 50%; i.e.,     that for every 2 posterior vitreous detachments detected conventionally, 3 will be detected     with the annular arrays.   "
212847|NCT00635752|"     The purpose of this study is to determine whether Trauma focused cognitive behavioral therapy     (TF-CBT)is more effective in the treatment of traumatized youth than treatment as usual(TAU).   "
212497|NCT00633867|"     The simplicity of use and intuitive function of the McGrath video-laryngoscope suggests it     may have a bigger role than as a back-up to conventional direct laryngoscopy and could     possibly be the first-line laryngoscope for situations where difficult intubations are more     likely or more hazardous. The incidence of difficult or failed intubation for an individual     anaesthetist is related to their experience, decreasing as experience increases. The purpose     of this trial is to evaluate the McGrath laryngoscope when used by relatively inexperienced     anaesthetists, who are those most likely to encounter difficulties.      The null hypotheses to be tested is that there is no difference between the Macintosh and     McGrath laryngoscope in terms of ease and success in intubation.   "
212498|NCT00633880|"     The purpose of this study is to see whether droxidopa is effective in treating symptoms of     neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic     Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta     Hydroxylase deficiency.   "
212499|NCT00633893|"     The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in     preventing venous thromboembolic (VTE) recurrence or death in patients who have completed     their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)   "
212500|NCT00633906|"     The Horizons Program will test the efficacy of a multi-session HIV prevention program for     African American female teens attending reproductive health clinics in Atlanta, GA.   "
212501|NCT00633919|"     This trial has been designed to evaluate the efficacy of specific immunotherapy with SLITone     Dermatophagoides mix compared with placebo in subjects with house dust mite allergic asthma,     based on asthma medication use during a period of 2 months with a high environmental exposure     to mites (autumn 2008).   "
212502|NCT00633932|"     This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily     for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in     comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux     Esophagitis at Week 8 according to the Los Angeles classification .   "
212503|NCT00633945|"     This study is being conducted to evaluate the safety and effectiveness of lenalidomide     (Revlimid®) in subjects with Cutaneous Lupus Erythematosus (CLE). The study drug will be used     in an off-label indication to treat 6 subjects for 12 months each. Men and women over the age     of 18, who have a biopsy proven diagnosis of CLE and who have failed standard treatment, will     be included in the study.   "
212517|NCT00634140|"     Ezetimibe is a drug which inhibits the absorption of both dietary and biliary cholesterol in     the small intestine. Ezetimibe has been approved for use in humans to lower serum     cholesterol.      The primary aim of this study is to determine if ezetimibe normalizes resting and residual     volume in patients with chronic acalculous cholecystitis.   "
212518|NCT00634153|"     By placing the medical record information of many subjects into a research registry,     researchers will be able to conduct research studies directed at increasing our knowledge     about Gastrointestinal Diseases.   "
212519|NCT00634166|"     The primary objective is to compare the effectiveness of treatment with Sulfamylon® solution     as the initial topical moist dressing over meshed autografts following the initial graft     procedure on preventing graft loss in a prospective cohort of subjects versus a historical     control group in a non-inferiority trial.   "
212504|NCT00633958|"     In spite of numerous advances in neuroimaging techniques, the diagnosis of pediatric brain     tumors relies on the pathologic evaluation of material obtained at the time of the initial     operation. While 18F-FDG-positron emission tomography (PET) helps identify higher-grade     lesions due to their increased glucose metabolism, the high tracer uptake of the normal     adjacent brains makes this modality of limited value. Fluorine-18 fluorothymidine (FLT) is a     new imaging agent that has two significant advantages in the imaging of CNS tumors. First,     this agent detects cellular proliferation directly, and second, the normal brain does not     take up the agent, making a positive area(s) easy to identify. Before embarking on a large     pediatric disease stratified assessment of FLT imaging in pediatric neurooncology patients,     the investigators are proposing a limited patient pilot study to evaluate the     biodistribution, dosimetry and specificity of this compound when compared to     immunohistochemical assessment of mitotic activity in newly diagnosed patients undergoing     surgical resection.   "
212505|NCT00633971|"     The purpose of this study is to determine if complex lymphedema therapy is effective in     decreasing disease severity and improving quality of life in patients with post thrombotic     syndrome.   "
212506|NCT00633984|"     The purpose of this study is to test a drug called d-cycloserine to see if it can help people     with a condition called social phobia. Social phobia is also called social anxiety     disorder. Social phobia is a constant fear of social or performance situations. Social     situations include group gatherings of any kind. Performance situations might include times     when a person would have to do something in public, such as speak up in class or at a     meeting. A person with this condition worries about being embarrassed, or about other     people's opinions. People with social phobia usually feel extremely anxious (nervous and     worried) about being the focus of attention. They often avoid social and performance     situations. This behavior can have a negative effect on the quality of their lives and     relationships.      In this study, we want to find out if d-cycloserine can help control social phobia when the     drug is added to the standard treatment for this condition. The standard treatment is     cognitive-behavior therapy (CBT). CBT is a form of talk therapy involving discussion with a     therapist, along with practicing the feelings or events that the person finds frightening.   "
212507|NCT00633997|"     This study will look at the skin accumulation of vildagliptin and its two major metabolites,     LAY151 and LAF237-O-Glucuronide, after vildagliptin 50 mg given orally twice a day for 10     days in both healthy volunteers and patients with type 2 diabetes.   "
212508|NCT00634010|"     Primary Aims:        -  To determine whether methadone used as first line strong opioid is superior to morphine          as evidenced by reduced pain over a 12-week treatment period in patients with advanced          cancer. Previous studies have demonstrated consistent improvement of pain control after          opioid rotation from morphine to methadone. In addition, the pilot study showed that          there was a trend towards lower pain intensity when methadone used as first line opioid          as compared to morphine. Researchers postulate that due to its superior analgesic          effects, methadone will result in better pain control over time as compared to morphine.        -  To determine whether methadone used as first line strong opioid is superior to morphine          as evidenced by reduced frequency of neurotoxicity, dose escalation and treatment          failure over a 12-week treatment period. Previous studies have demonstrated that          patients develop increased pain or neurotoxicity after chronic use of morphine and          require frequent opioid escalation. Researchers postulate that methadone will          demonstrate lower opioid induced neurotoxicity, less frequent dose escalation and less          treatment failure over 12-week treatment period as compared to morphine.      Secondary Aim:      -To perform an economic evaluation, comparing the costs and clinical benefits of methadone     and morphine. Researchers will perform an evaluation that incorporates both treatment and     potential downstream costs, as well as an examination of clinical benefits that incorporate     preferences, to perform an appropriate economic comparison. We postulate that methadone and     its associated costs will be cheaper than morphine. However, if one strategy is both more     expensive and clinically superior than the other, researchers are prepared to perform an     incremental cost-effectiveness analysis. In that case, researchers expect to show that the     greater pharmaceutical costs involved with morphine will make its use not be a cost-effective     strategy.   "
212525|NCT00634244|"     This randomized phase II trial is comparing three different combination chemotherapy regimens     to see how well they work in treating patients with relapsed or refractory acute myeloid     leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which     combination chemotherapy regimen is more effective in treating patients with relapsed or     refractory acute myeloid leukemia.   "
212509|NCT00634023|"     This is a cross-sectional study of symptom burden and clinical management. A subset of     patients who have attended the Primary Care (PC) office with reflux symptoms during a     retrospective period of 4 months (Index Visit) are invited to complete health survey     questionnaires and partake in a subject-physician/study nurse interview (Visit 1), in order     to assess the type, intensity and frequency of GERD symptoms at both visits and describe the     treatment provided. Additionally, the impact of GERD on subjects' life, productivity and     willingness to pay for GERD symptom relief will be explored. This design will give a     real-life clinical practice picture in a representative population of PC doctors and     subjects.   "
212510|NCT00634036|"     Asthmatics who are significantly overweight tend to have more severe symptoms, more flare     ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.      Researchers believe this occurs because excess adipose tissue (fat) in the body can cause     higher-than-normal levels of leptin and lower-than-normal levels of adiponectin in the blood.      The researchers of this study are testing a medication called pioglitazone in overweight     asthmatics because they believe it can help regulate leptin and adiponectin and that this may     improve symptoms of asthma.   "
212511|NCT00634049|"     The purpose of this study is to investigate the efficacy and safety of isavuconazole in the     treatment of renally impaired participants with invasive fungal infections caused by     Aspergillus and participants with invasive fungal disease caused by rare fungi.   "
212512|NCT00634062|"     This study investigates the hypothesis that instability in mood in patients with borderline     personality disorder will respond the mood stabilizing medication lamotrigine.   "
212513|NCT00634075|"     The purpose of this study is to determine whether a fish oil-based lipid emulsion, enriched     with ω-3 fatty acids, reduce proinflammatory cytokines and mortality rate in critically ill     patients with severe sepsis.   "
212514|NCT00634088|"     The purpose of this study is to determine the safety and preliminary effectiveness of     ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal     growth factor receptor 2 (HER2)-positive or metastatic breast cancer.   "
212515|NCT00634101|"     This study seeks to evaluate the clinical performance of a new CE marked daily disposable     contact lens that contains a wetting agent to a recently improved daily disposable contact     lens.   "
212589|NCT00626288|"     The purpose of this study is to determine whether Mesalazine is effective in the treatment of     the abdominal discomfort or pain of Irritable Bowel Syndrome patients.   "
212521|NCT00634192|"     This study is designed to provide data about the pharmacokinetics (PK), safety and     tolerability of two continuous treatment regimes of tobramycin nebulized solution delivered     via a 'soft mist' nebulizer in Cystic Fibrosis (CF) subjects. Each treatment period will last     8 weeks. Additionally the PK of patients with a normal forced expiratory flow in 1 second     (FEV1) (FEV1≥80% predicted) will be compared to patients with an abnormal FEV1 (FEV1<80%     predicted).   "
212522|NCT00634205|"     The purpose of this study is to determine the response rate to the combination of doxorubicin     and valproate acid in patients with MM failing after at least one previous chemotherapy     regimen including platinum derivatives .   "
212523|NCT00634218|"     Smoking rates are significantly higher among lesbian, gay, bisexual, and transgender (LGBT)     populations compared to the general population. LGBT individuals may be at increased risk for     experiencing psychosocial issues, e.g., negative moods, stress, alcohol/drug use, that have     been associated with smoking treatment failure in other groups of smokers. Technology, such     as the Internet and telephone, can be an effective method to reach a large number of smokers     and may be particularly effective in reaching hidden populations. Thus, the study seeks to     examine whether Internet-based counseling and/or telephone counseling can improve quit rates     for LGBT smokers.      Participants (N=600) will be randomly assigned to one of four conditions: 1) a Mail-based     Self Help (MSH) treatment; 2) MSH plus an Internet-based Smoking Treatment (IST); MSH plus     Telephone Counseling (TC) or 4) MSH plus IST plus TC. Participants in the MSH condition will     receive a self-help smoking cessation manual. In the IST condition, participants will receive     the manual plus access to an Internet-based intervention that includes social support. In the     TC condition, participants will receive the manual plus 6 telephone-based counseling     sessions. In the fourth condition, participants will receive the manual plus access to an     Internet-based intervention plus telephone counseling. Before starting treatment,     participants will complete questionnaires on smoking, nicotine dependence, demographics,     negative mood, and alcohol use. Participants will be contacted at 3, 6, and 12 months after     enrollment to determine whether they are smoking. The data will be analyzed to compare the     efficacy of the four treatments and to examine the possible influence of existing social     networks and level of negative mood on treatment outcome and to examine the possible     influence of residency (rural versus urban) on use of the Internet-based treatment.   "
212524|NCT00634231|"     This study will evaluate the administration of AdV-tk followed by valacyclovir in children     with malignant glioma, including glioblastoma multiforme (GBM) and anaplastic astrocytoma     (AA), as well as recurrent ependymomas in combination with radiation therapy. The primary     objective is to determine if this approach is safe and can be effectively delivered without     disturbing standard therapy.   "
212563|NCT00634738|"     In carpal tunnel syndrome,trigger points are often found in the biceps muscle,in the     aponeurosis of the biceps and in the pronator teres muscle.      We hypothesise that by eliminating these trigger points,using ischemic compressions, may     diminish the symptoms.   "
239523|NCT00994461|"     A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the     incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.   "
212526|NCT00634257|"     Primary Objective:      -To examine the association between self-rated spirituality/religiosity and coping strategies     (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients.      Secondary Objectives:        -  To examine the associations between self-rated spirituality/religiosity and physical          (ESAS) and psychological symptom reports (HADS), and quality of life (FACIT-sp) among          palliative care patients.        -  To examine the association between patient's self-reported spirituality/religiosity, and          primary caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire,          FACIT-sp).        -  To determine the frequency (self-rated spiritual pain scale when score is more or equal          than 1 in the scale 0 to 10) and intensity of self-rated spiritual pain in the          palliative care setting and to explore the association between spiritual pain, and          negative religious coping (Brief RCOPE), physical (ESAS) and psychological symptoms          (HADS), and primary caregiver distress (CQLS-C, caregiver self-assessment          questionnaire).        -  To examine the association between primary caregivers' spirituality/religiosity          (Appendix H, first question), religious coping strategies (Brief-RCOPE) and          psychological and family/caregiver distress (HADS, PSQI, CQLS-C, caregiver          self-assessment questionnaire), and caregivers' spiritual pain (Appendix F, second          question).   "
212527|NCT00634270|"     Treatment Overview      This phase II study will evaluate the activity of sirolimus in children and adults with NF1     and inoperable plexiform neurofibromas that have the potential to cause significant     morbidity. The following disease strata will be studied:      Stratum 1: Progressive plexiform neurofibroma(s) that have the potential to cause significant     morbidity. The endpoint will be time to tumor progression based on volumetric tumor     measurements.      Stratum 2: Plexiform neurofibromas without documented radiographic progression at trial     entry. The endpoint will be radiographic response. As of May 2009, Stratum 2 was closed to     enrollment. Stratum 1 is active.   "
212528|NCT00634283|"     This study examines the effects of an antidepressant medication and placebo on the brain     functioning of normal subjects. In this study, recordings of brain electrical activity are     being used to detect and monitor the response to treatment with venlafaxine IR (Effexor), a     drug used for the treatment of depression. The intent of this study is to test specific     hypotheses regarding:        1. long-term brain effects of a single course of antidepressant treatment        2. pharmaco-conditioning effects underlying antidepressant tolerance/sensitization        3. brain functional response to initial versus subsequent antidepressant trials in normal          healthy subjects.   "
212529|NCT00634296|"     This study aims to compare effects of inspiratory muscle training added by aerobic training     to aerobic training alone in heart failure patients with inspiratory muscle weakness. To do     so, strength and endurance of inspiratory muscles, functional capacity, quality of life,     heart rate variability and sleep apnea evaluations will be conducted in patients with heart     failure.   "
212530|NCT00634309|"     A study to evaluate the effect of Atacand on patients with heart failure with depressed left     ventricular function   "
212531|NCT00634322|"     The purpose of this study is to demonstrate whether use of glucarpidase facilitates     administration of the next cycle of chemotherapy as scheduled and improves safety and     tolerability of HDMTX given with LV   "
212532|NCT00634335|"     The purpose of this study is to characterize the cardiac adaptive changes of professional     Israeli bicyclists by using echocardiography.   "
212533|NCT00634348|"     The purpose of this study is to compare the efficacy and safety of ziprasidone and     aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder   "
212534|NCT00634361|"     This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia     prodrome.   "
213398|NCT00646425|"     The objective of this trial is to assess if treatment with basiliximab allows subjects to     taper off other immunosuppressive drug regimens without causing an increase in their uveitis.   "
212535|NCT00634374|"     Hypothesis: The Rx medibottle is more effective than the oral syringe when giving infants     less than 2 years of age a bitter-tasting medication (prednisolone syrup).      Summary: Infants who were admitted to the pediatric floor with a respiratory illness at the     Bronx-Lebanon Hospital were offered the chance to take part in the study. If these children     needed prednisolone syrup for their treatment, were less than 2 years old and were     bottle-fed, and were in stable condition, they qualified. They were randomly assigned (just     by chance), into a control arm, where they received medication using the oral syringe, or an     intervention arm, where they were given medication using the Rx medibottle. How well the     infant accepted the bitter-tasting medication was compared between the two arms using an     infant medication acceptance scale. The scale was administered and a score generated by two     raters: the nurse who administered the medication, and a child life therapist who witnessed     the administration. The time needed to give the medication, the drug delivery device's     ability to administer the entire dose of medication and the mother's satisfaction with the     method used were also compared between the two arms.   "
212536|NCT00634387|"     Anthocyans modify cardiovascular and sympathetic function   "
212537|NCT00634400|"     A study to evaluate the effect of Atacand on patients with heart failure with depressed left     ventricular function   "
212538|NCT00634413|"     The purpose of this study is to assess the tolerability and efficacy of inhaled theophylline     (ADC4022) on markers of pulmonary inflammation (white blood cells) in induced sputum and in     bronchial biopsy samples in subjects with moderate to severe Chronic Obstructive Pulmonary     Disease (COPD) when co-administered with budesonide and compared to placebo.   "
212539|NCT00634426|"     The aim of this trial is to evaluate the differences in pain relief, neurological function,     quality of life and survival in patients with metastatic epidural spinal cord compression     (MESCC) who are managed with a combination of surgery and radiotherapy versus radiotherapy     alone.      Further we shall evaluate cost-effectiveness of the two treatment approaches.   "
212564|NCT00634751|"     This study involves the use of oxaliplatin, capecitabine, and sorafenib which are all drugs     approved by the Food and Drug Administration (FDA) for use in the treatment of different     cancers. Their use in this exact combination is considered experimental for the treatment of     pancreas and biliary tract; however the combination has been tested in a preliminary trial.     We are also testing a survey designed. The purpose of this research study is to investigate     the chemotherapy drug sorafenib in combination with oxaliplatin and capecitabine     chemotherapies for the treatment of pancreas and biliary tract cancers.to help patients     report their side effects from chemotherapy treatments.   "
212540|NCT00634439|"     Using a proprietary insurance health claims database, Eli Lilly and Company has contracted     with an external party to conduct a retrospective cohort study of health claims for the time     period from 1 January 2003 through 31 December 2006 (with follow-up of patients through 30     June 2007). This study will evaluate the potential association between atomoxetine and     cerebrovascular events. In this study, the incidence of selected cerebrovascular outcomes as     represented in health claims data among adult patients who initiate therapy with atomoxetine     will be estimated. In particular the study will focus on cerebrovascular accident (CVA) and     transient ischemic attack (TIA) as the outcomes of interest. The incidence for each outcome     among atomoxetine initiators will then be compared to the incidence in a cohort of similar     patients who initiate stimulant treatment and an age and gender-matched general population     cohort. The atomoxetine and stimulant-initiating cohorts will be matched on a broad variety     of variables, including age, gender, diagnoses, medication use, and healthcare utilization     through the use of propensity score matching in order to minimize the influence of     confounding by indication. The analysis will include the cohorts (atomoxetine and stimulant     initiators) from a previous completed study with increased follow-up time (1 January 2003     through 30 June 2007) and accrue new atomoxetine and stimulant ADHD medication initiators     over a 2 year period, so that the study will represent initiators between January 1, 2003 and     December 31, 2006 with follow-up through June 30, 2007.   "
212541|NCT00634452|"     To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or     refractory Hodgkin's Lymphoma (HL).   "
212542|NCT00634465|"     Assessment of segmental spine motion has been and continues to be, a difficult clinical     problem. Errors of up to 10 degrees for simple measurements of flexion, extension and side     bending have been recorded using conventional radiographs (xrays.) These errors are usually     associated with the inability to acquire three-dimensional positions and inaccurate reference     points. It has, therefore, been extremely difficult to measure small changes in vertebral     alignment, which may prove to be an early, clinically significant, indicator of potential     problems. Radiostereometric Analysis, or RSA, is an accurate in vivo measurement technique     using two simultaneous radiographs. It provides researchers with three dimensional motion     analyses to look not only at routine flexion/extension, but also other rotational and     translational changes. The measurement accuracy offered by this technique far exceeds the     manual techniques currently used. The purpose of this study is to assess the amount of motion     in the lumbar spine in patients with the AST Stabilimax BAR. The AST Stabilimax BAR is     designed to allow for motion in the spine while providing the necessary stability to the     spinal segment. The amount and degree of this motion is currently unknown clinically. By     using tantalum bead markers placed in the spine at the time of the surgery, RSA analysis can     determine the amount and degree of motion of the implanted construct. Two questions will be     examined with this data: 1) what is the amount of sagittal and coronal plane motion that     occurs in vivo with the AST Stabilimax BAR system? and 2) will this change over the 2 year     time frame for this study?   "
212543|NCT00634478|"     The hypothesis is that prelemniscal radiation (RaPRL) deep brain stimulation (DBS) is more     effective for axial (head/neck/voice) tremor, and perhaps, appendicular tremor control in     essential tremor patients.   "
212544|NCT00634491|"     The purpose of this study is whether Acetazolamide is effective in prevention of contrast     nephropathy   "
212545|NCT00634504|"     The purpose of this study is to investigate whether the administration of Voraxaze reduces     exposure to leucovorin and its active metabolite to below the level achieved in patients who     have not received Voraxaze.   "
212737|NCT00628472|"     This single blinded randomized pilot study was performed on 21 Caucasian females to determine     if injections through follicular openings were less painful than traditional injections for     cosmetic botulinum toxin type A injections.   "
212546|NCT00634517|"     This 4-week clinical study evaluates the efficacy and safety of Albuterol Sulfate HFA     Inhalation Aerosol in comparison with the Active Control, Proventil-HFA (3M Pharmaceuticals,     Inc) in pediatric patients (4-11 years old) with mild-to-moderate asthma. In addition,     pharmacokinetic profile in this population will be evaluated using a population PK approach     with sparse blood samples.   "
212547|NCT00634530|"     This is a randomized clinical trial for evaluate the impact of a nutritional intervention in     the weight control of pregnant women according to the nutritional status, and consequently,     the reduction of pregnancy complications.      The sample of this study will be composed by 318 pregnant women in the pre-natal care unit of     the Health Center in Viamão city / Rio Grande do Sul, including women between the 10th and     25th weeks of gestation, aged up to 35 years old. The eligible pregnant women will be invited     by the fieldworks to participated in the trial after be informed about the overall aims of     the study. These women willing to participate will be randomly allocated to either the     intervention or control group. The intervention group received specific guidelines about     feeding practices appropriate to each nutritional status.      Data on pregnant women will be collected through a questionnaire in both groups, and to     assess the food intake, three 24-hour food recall will be applied in the interventional group     and two recall in the control group, in initial and final gestational period. In all     appointments pregnant women of the two groups will be weight and classified according to Body     Mass Index of pre-gestational (BMI).      The dietary advices will be elaborated by the author of the project and nutrition graduation     students of Federal University of Health Science of Porto Alegre.   "
212548|NCT00634543|"     The purpose of this study is to evaluate the effectiveness and safety of tramadol     hydrochloride (HCl) 37.5 miligram (mg)/acetaminophen 325 mg compared to gabapentin in     participants with diabetic neuropathic (nerve disorder caused by diabetes mellitus) pain.   "
212549|NCT00634556|"     Dr. Kevin J. Black at Washington University is conducting a study to learn whether we can use     MRI scans to test dopamine function in the brain and to determine whether the brain performs     memory tasks differently in Tourette Syndrome (TS). TS is a movement disorder characterized     by vocal tics (sounds) and motor tics (movements). We will measure how and where brain     activity changes using magnetic resonance imaging (MRI) scans during memory tasks and after     taking levodopa. Levodopa is a drug commonly used for the treatment of Parkinson's disease     (PD), a very different movement disorder.   "
212550|NCT00634569|"     This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5%     DIF in the pediatric population.   "
212551|NCT00634582|"     RATIONALE: Paricalcitol may help prostate cancer cells become more like normal cells, and to     grow and spread more slowly. It may also stop the growth of tumor cells in bone.      PURPOSE: This phase II trial is studying how well paricalcitol works in treating patients     with advanced prostate cancer and bone metastases.   "
212552|NCT00634595|"     Angiogenesis, the formation of new blood vessel from existing vessels, is essential for tumor     growth and metastasis. Antiangiogenic therapies inhibit the growth of genetically stable     endothelial cells, and most tumors should starve to death with little acquired resistance.     Endostatin has been shown to block endothelial cell proliferation, survival, and migration.     Antitumor activity of endostatin protein has been demonstrated in various murine and human     tumors in animal model studies without any detectable toxicity. Endostatin gene therapy could     directly express the highly bioactive protein in vivo by means of the mechanism of eukaryotic     expression system as post-translational modification and folding, as well as overcoming the     challenge of the long-term storage and the cumbersome daily administration of endostatin     protein.      E10A is a replication-deficient recombinant adenovirus containing a wild-type human     endostatin transgene constructed from serotype 5 adenovirus (Ad5). Preclinical studies     demonstrated that intratumoral injection of E10A provided significant tumor growth inhibition     and sustained elevation of endostatin in blood and tumor tissue in hepatocellular carcinoma,     nasopharyngeal carcinoma, and tongue cancer animal models. A Phase I clinical trial of E10A     we conducted showed that repetitive intratumoral injection of E10A resulted in a small and     sustained elevation of endostatin in blood and had a mild antitumor activities with very     limited toxicity. The major toxicity was transient and manageable fever. A randomized Phase     III trial in nonsmall-cell lung cancer showed endostatin improved response rate and time to     tumor progression in combination to chemotherapy. Therefore, we designed a randomized phase     II trial to explore the safety and effectiveness of E10A combined with chemotherapy in the     treatment of patients with head and neck cancer.   "
212553|NCT00634608|"     The specific aim of this proposed project is to implement a standard process for integrating     MedlinePlus health information prescriptions into the clinic workflow.      Hypothesis 1: Individuals in the intervention group who receive tailored email health     information with provider selected MedlinePlus links and added commentary for patient     specific conditions will be more likely to seek information / use MedlinePlus compared with     individuals in the control group.      Hypothesis 2: Individuals in the intervention group who receive tailored email health     information with provider selected MedlinePlus links and added commentary for patient     specific conditions will be more satisfied with the information received compared with     individuals in the control group.   "
212554|NCT00634621|"     The purpose of this study is to determine the effectiveness of hexaminolevulinate (Hexvix) in     the diagnosis and treatment of patients with non-invasive bladder cancer and if it results in     a change in patient management.   "
212555|NCT00634634|"     Letrozole is an aromatase inhibitor that is approved in the first-line treatment of     postmenopausal women with hormone receptor-positive or hormone receptor unknown locally     advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by     blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.     This phase I/II trial is studying the side effects and best dose of sorafenib when given in     combination with letrozole and to see how well they work in treating postmenopausal women     with metastatic breast cancer.   "
212567|NCT00634790|"     The purpose of this study is to assess the long-term safety and tolerability of alprazolam     extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in     anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR     and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will     also be evaluated.   "
212568|NCT00634803|"     This study is designed to develop an effective psychotherapy for chronic pain and opioid     dependence.   "
212569|NCT00634816|"     Specific subgroups of children who survive treatment for childhood malignancies have been     shown to develop relative osteopenia following chemotherapy and are felt to be at risk for     developing osteoporosis later in life due to their inability to reach peak bone mass during     childhood.   "
212884|NCT00636246|"     This study was designed to determine if the novel combination of the SSRI, sertraline, and     the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable     safety profile of SSRIs.   "
212556|NCT00634647|"     Background:      Satraplatin is an experimental drug that may be of benefit to patients with prostate cancer.      Prednisone is approved for treating prostate cancer.      The gene excision repair cross-complementing rodent repair deficiency complementation group 1     (ERCC1) helps repair cell damage caused by satraplatin. It is possible that patients who have     a variant of this gene will not benefit from treatment with satraplatin because the drug will     not be able to damage the cancer cells effectively.      Objectives:      To determine if satraplatin may help treat prostate cancer in patients with certain variants     of the ERCC1 gene.      Eligibility:      Patients with advanced androgen-independent prostate cancer whose disease has not responded     to hormonal therapy or at least one type of chemotherapy and whose x-rays, scans or other     tests have shown their cancer to be spreading.      Design:      Participants have a blood test to determine if they have a variant of the ERCC1 gene.      Participants take satraplatin by mouth every day for 5 consecutive days out of every 35 days     and prednisone by mouth every day. These 35-day treatment cycles may continue for 6 months or     longer, depending on the benefits and side effects of the treatment.      During the treatment period, patients undergo the following tests and procedures:        -  Blood tests on days 1 of the treatment cycle.        -  Weekly blood draws for the first 3 treatment cycles.        -  Imaging studies (e.g., bone scans, computed tomography (CT) scans) every two cycles to          determine the response to treatment.        -  Surgical or medical suppression of testosterone in patients whose cancer cells continue          to grow due to exposure to the hormone....   "
212557|NCT00634660|"     The purpose of this study is to assess the safety and tolerability of injections of     rAvPAL-PEG in subjects with PKU.   "
212558|NCT00634673|"     This study will be conducted in type 2 diabetic patient's to evaluate the if there is a     different response of serum lipids after a standard meal (rich in saturated fatty acids) in     patients who have the presence of a genetic alteration. This alteration that will be     evaluated is a polymorphism, change of an amino acid in the gene of FABP2. This gene that can     influence the absorption of lipids in the intestine and subjects who have the altered     genotype (presence of T allele) can have an abnormal lipid profile as compared to subjects     without this genotype.   "
212559|NCT00634686|"     The purpose of this study is to examine the effects of essential fatty acid (EFA)     supplementation on bone metabolism and frailty in postmenopausal women. The overall     hypothesis is that EFA supplementation, via its immunoregulatory and anti-inflammatory     activity, will decrease bone turnover, decrease prostaglandins and cytokines associated with     bone metabolism and frailty, and change physical outcome measures associated with frailty in     postmenopausal women with low bone mass and frailty.   "
212560|NCT00634699|"     The purpose of this study is to find the efficacy of treating the muscles in the inside     (biceps,pronator teres) of the arm in order to eliminate the carpal tunnel syndrome .The     authors hypothesise that eliminating the trigger points located in these muscles would     diminish the symptoms associated with the carpal tunnel syndrome.   "
212561|NCT00634712|"     A study to evaluate the effect of Atacand on patients with heart failure with preserved left     ventricular function   "
212562|NCT00634725|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor     cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or     radiation therapy is most effective in treating pancreatic cancer.      PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or     without capecitabine and/or radiation therapy to see how well it works compared with giving     gemcitabine together with or without erlotinib in treating patients with locally advanced     pancreatic cancer that cannot be removed by surgery.   "
212565|NCT00634764|"     Obesity is a significant health issue in the United States with 30% of the US population     considered obese defined as a body mass index above 30 kg/m2. Obesity is associated with long     term health complications including diabetes and cardiovascular disorders. During pregnancy,     obesity is associated with an increased risk of fetal macrosomia and birth injury, as well as     increased risk of gestational diabetes, preeclampsia, cesarean birth, and preterm birth. The     intrauterine environment has been purported to influence the early childhood and lifelong     risk of obesity and the metabolic syndrome (obesity, hyperlipidemia, and insulin resistance     [IR]). The Institute of Medicine guidelines for maternal weight gain in pregnancy provide an     estimate for population goals, but may be inadequate for individual patient needs. Other     factors, such as the degree of maternal IR and resting metabolic rate (RMR) may be more     predictive of actual nutritional needs during pregnancy. A better determination of caloric     and exercise needs may allow the development of more specific dietary recommendations during     pregnancy. Optimal nutrition will result in improved maternal and neonatal outcomes. As the     intrauterine environment may have important impacts on neonatal and childhood metabolic and     cardiovascular outcomes, creation of a favorable intrauterine environment through optimal     maternal nutritional and exercise guidelines may reduce well documented problems such as     fetal macrosomia, birth injury, cesarean delivery, and later predisposition toward childhood     obesity.      The goal of this pilot trial therefore is to correlate maternal resting metabolic rate,     dietary characteristics, and insulin resistance levels with fetal birth weight and body     composition in an effort to determine which factors are associated with excessive fat mass in     the neonate, placing them at increased lifetime risk of obesity.      We hypothesize that women with lower resting metabolic rates (RMR) in the first trimester     will demonstrate a greater maternal weight gain, when adjusted for caloric intake and     activity. It is also hypothesized that for a given RMR, the degree of maternal insulin     resistance (IR) predicts birthweight adjusted for a given caloric intake. A third hypothesis     is that women with increased insulin resistance (measured by HOMA) will result in neonates     with larger birth weights and a greater degree of neonatal fat mass as measure by DEXA scan,     adjusted for RMR and diet characteristics.   "
212566|NCT00634777|"     Patients with advanced head and neck squamous cell carcinoma (HNSCC) may benefit from     organ-preservation treatment based on combination of chemotherapy and radiotherapy without     compromising disease-free and overall survival. In patients with initially advanced regional     disease, there is controversy about the place of routine planned lymph node neck dissection     after chemoradiotherapy, especially in responding patients without clinically invaded     residual lymph nodes. There is uncertainty about the lymph nodes status after chemoradiation     because the structural imaging modalities (CT, MRI) lack sensitivity and specificity : small     positive lymph nodes are not detected, and residual large lymph nodes can be sterilized (      ghosts nodes  with no sign of viable tumor cells at histopathology). Despite the absence of     evidence based on prospective study, in numerous institutions currently, head and neck     surgeons are quite reluctant to operate on for neck dissection patients with a complete     clinical and radiological response following chemoradiation.      Metabolic imaging of tumors using PET and the glucose analog FDG has proven effective in head     and neck SCC, especially after treatment to differentiate disease progression from     radiation-induced inflammation.1 Several studies have shown that the metabolic response could     predict the presence or absence of residual tumor cells in the primary tumor as well as the     probability of relapse .2-4 Conflicting results have been reported on the use of PET to     predict the pathological nodal status after chemoradiation, with negative predictive values     ranging from 14 % to 100 %.5,6 Discrepancies observed might be due to the fact that PET was     performed at variable time points after the end of radiotherapy. Ideally, PET should be     performed as late as possible so that tumor regrowth can begin and become detectable,     increasing the sensitivity of the procedure.   "
216077|NCT00679939|"     The purpose of this study is to determine the effects of rosiglitazone on the bone in     postmenopausal women with type 2 diabetes mellitus   "
212570|NCT00634829|"     This clinical study will evaluate and establish the protective effects of Amphastar's     Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA), in preventing exercise-induced     bronchoconstriction (EIB) in adolescent and adult asthmatic patients, in comparison with (1)     Proventil®-HFA (Reference drug and Active Control ), and (2) Placebo-HFA control (HFA     propellant only). Safety of the test drug, Albuterol-HFA, will also be evaluated in     comparison to the Active and Placebo Controls. Analyses will be performed to determine if the     Armstrong's Albuterol-HFA has resulted in a significant bronchoprotective effect, with     attenuated Max % Fall in FEV1, in comparison to the Placebo-HFA control.   "
212571|NCT00634842|"     This trial is conducted in the United States of America. The aim of this trial is to explore     how different fasting blood glucose targets affect glucose control in patients with type 2     diabetes, when patients are empowered to do dose adjustments themselves.   "
212572|NCT00634855|"     The objective of this study is to determine whether there are alterations in the population     of endothelial progenitor cells in umbilical cord blood samples of infants born in the     setting of maternal preeclampsia or fetal growth restriction.   "
212573|NCT00634868|"     The Qray device is emitting broad light energy that is intended for diabetic ulcer healing.     The study is double blinded.   "
212574|NCT00634881|"     RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them.      PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab in     treating patients with B-cell chronic lymphocytic leukemia.   "
212575|NCT00634894|"     Primary Objective:      1. Evaluate the efficacy of letrozole to increase the duration of progression-free survival     (defined as time to earliest occurrence of local or distant recurrence or clinically     significant elevation in CA-125) when used as adjuvant treatment after completion of primary     surgery and first line platinum containing chemotherapy in patients with optimally debulked     (< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal     cancer.      Secondary Objective:      1. Observe the incidence of local and distant recurrences.   "
212576|NCT00634907|"     Several human genes affect how medications are metabolized by the body. It is believed that     knowledge of variations of these genes can help health care providers better manage an     anticoagulation medicine called warfarin (Coumadin®)and as a result decrease patient problems     with bleeding or the development of blood clots. This study was designed to evaluate if     genetic testing can improve warfarin initiation better than usual care.   "
212577|NCT00634920|"     This study is designed to evaluate if early conversion to everolimus from cyclosporine in de     novo renal transplant recipients can improve long-term renal function and slow down the     progression of chronic allograft nephropathy   "
212578|NCT00634933|"     This study will evaluate the efficacy and safety of two dosing regimens of a compound known     as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid     arthritis.   "
212579|NCT00634946|"     The purpose of this study is to determine whether SI-6603 is effective in the treatment of     lumbar disc herniation.   "
212580|NCT00626171|"     The objective of this study is to determine the effect of cigarette smoking on inflammatory     cell recruitment to the lungs after an allergen challenge, in non-smoking and currently     smoking mild asthmatic subjects.      When comparing non-smoking asthmatics to smoking asthmatics, do differential cell counts     obtained from inflammatory cells in induced sputum after allergen challenge differ?      Will differential cell counts show a decline in inflammatory cells in the induced sputum of     asthmatics who have refrained from smoking for eight weeks?      This study is a randomized, case-controlled study. The first part of the study requires     smoking and non-smoking subjects who will attend 2 study periods of 3 consecutive days     (triad). In each triad, they will be challenged with allergen or diluent by inhalation, in a     random order, and each triad is separated by a washout period. In the second part of the     study, current smokers will be invited to undergo another allergen challenge 8 weeks of     smoking cessation.   "
212581|NCT00626184|"     To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac     Disease   "
212582|NCT00626197|"     This is a Phase III, randomized, double-blind, placebo-controlled, multicentre,     parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC     (corticosteroid plus one of two immunosuppressant regimens) compared with placebo added to     SOC in patients with WHO or ISN Class III or IV lupus nephritis.   "
212583|NCT00626210|"     Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration     for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work     sleep disorder. Each of these problems is characterized by difficulty sleeping at night and     excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this     sleepiness. The idea behind this treatment is that sleepiness that leads to napping during     the day prevents a patient from being tired or sleepy enough to get good sleep at night. This     study is designed to determine if the medication can reset participants' sleep/wake rhythm     to a more normal rhythm.   "
212584|NCT00626223|"     A randomized prospective study was done to determine whether i.v. 5-methyltetrahydrofolate vs     oral folate improved survival in ESRD patients. Homocysteine, CRP, Lp(a), albumin, folates,     vitamin B6 and B12 were checked. The 5-MTHF treated group was associated with lowered C     reactive protein and higher survival than the folate treated group.   "
212585|NCT00626236|"     It is hypothesized that, when given at the lowest effective dose, the favorable side effect     profile combined with it's lower propensity for weight gain would make SPN-810 a candidate     for treatment of persistent serious conduct problems in pediatric subjects with ADHD.   "
212586|NCT00626249|"     24 diabetics with mild & moderate renal disease and 12 diabetics without renal disease. One     screening, one dosing & one follow-up visit with TechnosphereÂ® Inhalation Powder given at     Visit 2 via MedToneÂ® Inhaler and PK testing at 26 designated time points   "
212587|NCT00626262|"     The purpose of this study is to examine the effects of Nexium at a dose of 20mg administered     orally compared to intravenously on the maximum acid output in subjects with symptoms of     Gastroesophageal reflux disease (GERD).   "
216117|NCT00680472|"     The objective of this study is to determine the efficacy of HKT-500 in subjects with acute     shoulder pain   "
212590|NCT00626301|"     The purpose of this study is to evaluate the efficacy (clinical, immunological, virological     outcome), pharmacokinetics and safety of lopinavir/ritonavir (LPV/r) monotherapy maintenance     in Thai children after viral load suppression with double boosted protease inhibitors (PIs).   "
212591|NCT00626314|"     The purpose of this study is to evaluate the safety and effectiveness of injecting myoblasts     (grown from your own skeletal muscle), using a catheter device, directly into the damaged     heart muscle for treatment of severe heart failure.   "
212592|NCT00626327|"     Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy     toddlers   "
212593|NCT00626340|"     The purpose this study is to measure cortical gama-aminobutyric acid levels (GABA) levels in     menopausal women with major depressive disorder and healthy subjects using nuclear magnetic     resonance spectroscopy (MRS). Measurements will be compared in 1) menopausal healthy subjects     before and after estrogen replacement, and after fourteen days of medroxyprogesterone     administration; and 2) in depressed menopausal subjects before and after treatment of their     depression with antidepressant alone, estrogen alone or antidepressant plus estrogen.     Cortical GABA levels will be correlated with plasma GABA and neurosteroid levels.     Neurosteroids to be measured include progesterone, allopregnanolone, pregnenolone, and     pregnenolone sulfate.   "
212594|NCT00626353|"     Objective: To evaluate the effect of interdisciplinary home rehabilitation of patients with     acute stroke. The trial seeks to evaluate:        1. Can early home rehabilitation affect the degree of independence (motor capacity,          activities of daily living and cognitive status), quality of life and the possibility of          discharge to own home?        2. Can home rehabilitation influence the length of admission at a rehabilitation centre in          the municipality, readmission to hospital, the use of healthcare services and death?        3. To what extend can home rehabilitation be implemented according to finances? Materials          and methods: Patients at the age 18 years or more admitted to the stroke unit at the          University Hospital of Gentofte. The patients were eligible when meeting the following          criteria: symptoms of stroke, need of rehabilitation tree days after admission, living          in own home in the Municipality of Gentofte, Lyngby-Taarbaek or Rudersdal and Modified          Rankin Score between 0 and 3.      The trial was conducted as a randomised controlled trial. The control group patients were     rehabilitated according to normal procedure. The intervention group patients were     rehabilitated according to normal procedure and were additionally rehabilitated at home     during admission and four weeks after discharge.   "
212595|NCT00626366|"     The purpose of this study is to determine the distribution of nasal sprays and nasal drops.     We hypothesize that nasal drops will reach the frontonasal region more often than nasal     sprays.   "
241229|NCT01018264|"     This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing     symptoms of overactive bladder in Parkinson's disease (PD) patients.   "
212598|NCT00626405|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, paclitaxel albumin-stabilized     nanoparticle formulation, and carboplatin, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as bevacizumab, can block tumor growth in different ways. Some block the ability of     tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. It is not yet known whether bevacizumab is more effective     when given together with temozolomide or paclitaxel albumin-stabilized nanoparticle     formulation and carboplatin in killing malignant melanoma cells.      PURPOSE: This randomized phase II trial is studying the side effects of giving temozolomide     together with bevacizumab and to see how well it works compared with giving bevacizumab     together with paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in     treating patients with stage IV malignant melanoma that cannot be removed by surgery.   "
212599|NCT00626418|"     The purpose of this study is to assess the efficacy and tolerability of single doses of     aplindore compared to placebo in RLS. Patients will be required to spend 5-8 nights in a     sleep laboratory. This includes 1 adaptation night, 1 placebo night, and 3-6 drug treatment     nights. Ascending doses of active drug will be administered on study nights 3 through 5 to     determine the maximum well tolerated efficacious dose (defined as a decrease in Periodic Limb     Movement Index (PLMI) of at least 50% from placebo baseline). If an efficacious dose cannot     be identified the Investigator in consultation with the sponsor may decide to examine higher     doses in up to 3 additional PSG nights in an attempt to identify a tolerable efficacious     dose. This study will utilize up to 24 evaluable patients, each meeting International     Classification of Sleep Disorders (ICSD-2) diagnostic criteria for primary RLS who are not     currently taking any RLS medication including DAs ( and L-dopa) or who are able to     discontinue their RLS medication at least 5 half-lives prior to the adaptation night.   "
212600|NCT00626431|"     To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month     depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A     formulation will be deemed successful if the percentage of subjects with suppression of     testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of     the 2-sided 90% confidence interval), a protocol-specified criterion.   "
212601|NCT00626444|"     Eligible candidates will be adults with aggressive or very aggressive NHL (WHO classification     diagnosis confirmed by histological tumor examination). Patients must have failed one or more     prior NHL chemotherapy or antibody therapy with curative intent, and the disease must not     have progressed within 60 days of last therapy. In addition, patients must not be candidates     for potentially curative therapy, such as HSCT, or they must have refused these alternative     therapies. Full inclusion/exclusion criteria are available. History and physical examination,     and laboratory and imaging analyses will be done within 14 days prior to registration.     Intravenous ascorbic acid will be given in a dose based on the plasma vitamin C level to     reach a level in the range of 300 to 350 mg/dL. Vitamin C infusions will be given three times     a week on a schedule that allows at least 24 hours between each infusion, for a total of ten     weeks (30 infusions). If disease progression occurs before or at the ten week assessment,     then we discontinue protocol, based on futility. Toxicity and adverse events also will result     in immediate discontinuation (details available in full protocol). If there is lack of     disease progression or disease improvement, proceed and reassess again at 10 week intervals,     for a total of three 10 week intervals. Initial criteria are based upon the criteria from the     International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson et al.,     Report of an international workshop to standardize response criteria for non-Hodgkin's     lymphoma, Journal of Clinical Oncology, 1999, Vol. 17, No4, 1244-1253); response for this     study will utilize PET in accordance with revised criteria (Cheson et al. Revised response     criteria for malignant lymphoma. J of Clin Oncol 2007; 25(5): 579-586). We select 20 patients     as an appropriate study size to evaluate a true response rate to therapy, compared to just     the observed response.   "
212602|NCT00626457|"     Losing weight has many health benefits for women such as reducing the risk of heart attacks,     high blood pressure, diabetes, and cancer. However, women often struggle with maintaining the     weight they have lost. This may be because they need to learn skills for maintaining weight,     not just losing weight.      When is the optimal time is to learn these maintenance skills? It may be better to lose     weight first and then learn maintenance skills since people may feel good about the weight     they have lost and be motivated to maintain. Alternatively, it may be better to learn     maintenance skills first and then lose weight since they may experience how easy it is to use     these maintenance skills and become confident they can maintain a weight loss in the future.      Therefore, this study will examine whether learning these maintenance skills--before or after     losing weight--helps women succeed at maintaining weight loss.   "
212603|NCT00626470|"     Fractures just below the hip often are treated with a so called Gliding Screw and Plate     (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches     to the DHS has become available which is claimed to give extra support to the fracture. In a     prospective randomised study we wish to test the hypothesis that the TSP does not give any     additional stability to the fracture treated with the DHS.   "
212604|NCT00626483|"     RATIONALE: Monoclonal antibodies, such as basiliximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     tumor cells. Vaccines may help the body build an effective immune response to kill tumor     cells. Giving these treatments together may kill more tumor cells. Granulocyte     Macrophage-Colony Stimulating Factor (GM-CSF) is a powerful adjuvant capable of stimulating     macrophage function, inducing proliferation and maturation of DCs, and is able to enhance     T-lymphocyte stimulatory function. Intradermal administration of GM-CSF enhances the     immunization efficacy at the site of administration      PURPOSE: This clinical trial is studying how well basiliximab works in treating patients with     newly diagnosed glioblastoma multiforme and temozolomide-caused lymphopenia who are     undergoing targeted immunotherapy.   "
212605|NCT00626496|"     Blood and lymph node cancers can begin in either the lymphatic tissues (as in the case of     lymphoma) or in the bone marrow (as with leukemia and myeloma), and they all are involved     with the uncontrolled growth of white blood cells. There are many subtypes of these cancers,     e.g., chronic lymphocytic leukemia and non-Hodgkin lymphoma. Since there is evidence that     these cancers cluster in families, this study aims to understand how genetics and     environmental exposures contribute to the development of these cancers.   "
212645|NCT00627250|"     The purpose of this study is to determine if amantadine hydrochloride given 100 mg in the     morning and at noon is safe and effective in the treatment of mood and behavior changes (i.e.     irritability) after sustaining traumatic brain injury.   "
212606|NCT00626509|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed. Giving it after surgery may kill any tumor cells that remain after surgery. It is     not yet known whether sunitinib is more effective when given before or after surgery in     treating kidney cancer.      PURPOSE: This randomized phase II trial is studying the side effects of sunitinib and to     compare how well it works when given before or after surgery in treating patients with     metastatic kidney cancer.   "
212607|NCT00626522|"     The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for     investigation in Phase III clinical trials   "
212608|NCT00626535|"     This study compares 4 weeks of treatment with Esomeprazole 20 mg once daily to Placebo in the     treatment of Upper Abdominal Pain in patients with Symptomatic Gastroesophageal Reflux     Disease (sGERD)   "
212609|NCT00626548|"     Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan)     in hormone resistant prostate cancer (HRPC).      This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can     improve progression-free survival and overall survival against a background of existing     prostate cancer treatments.      ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread     by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054     (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA     after surgical or medical castration but have no evidence of metastases.      All patients participating in this clinical trial will receive existing prostate cancer     treatments in addition to trial therapy.      Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive     placebo in addition to standard prostate cancer therapy. By participating in this trial there     is a 50% chance that patients will receive an agent that may slow the progression of the     tumour.      No patients will be deprived of standard prostate cancer therapy.   "
212610|NCT00626561|"     Objectives:      Primary:      To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell,     large cell, and neuroendocrine cervical and uterine cancers, as measured by progression-free     survival.      Secondary:        1. To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small          cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by          overall survival.        2. To determine the response rates in patients with recurrent small cell, large cell, and          neuroendocrine cervical and uterine cancers when treated with bevacizumab and          paclitaxel.        3. To characterize the quality of life (QoL) in patients with recurrent small cell, large          cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and          paclitaxel.        4. To determine the nature and degree of toxicity in patients with advanced or recurrent          small cell, large cell, or neuroendocrine cervical and uterine cancers when treated with          bevacizumab and paclitaxel.   "
212623|NCT00626730|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose     radiation therapy after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying radiation therapy to see how well it works in     treating patients who have undergone surgery for newly diagnosed grade II or grade III     meningioma.   "
212611|NCT00626574|"     This is a prospective, randomized, double-blinded, placebo controlled pilot safety study that     will enroll a total of twenty subjects. Subjects will be adults (30-75) who have sustained a     SAH secondary to cerebral aneurysm rupture and who present with minimal neurological     symptoms. All subjects will have a Hemoglobin less than or equal to 12 g/dL within 24 hours     prior to study entry and undergo operative aneurismal clipping. Subjects will be randomized     into two groups, ten subjects receiving the drug and ten subjects receiving the placebo. The     subjects will receive three intravenous injections of study drug or placebo, once before     undergoing operative aneurysmal clipping (study Day 1) and again for two additional days     (study Day 2 and study Day 3).      There are 3 phases to this trial:      Screening Phase - patients will present with Subarachnoid hemorrhage (SAH) and prepped for     surgery within 36 hours Treatment Phase - first pre-operative dose before surgery (Study Day     1), post-operative (Study Days 2 and 3) Follow-up Phase- Study Day 4 through discharge, 6-7     week follow-up Primary Objective: To determine the safety of administering intravenous doses     of Procrit® once daily for three consecutive days to patients with aneurysmal SAH before and     after vascular clipping by comparing the incidence of thrombotic events, hemoglobin and 6-7     week mortality between the Procrit® and placebo groups. Secondary Objectives: To determine if     administration of Procrit® prior to aneurysm clipping reduces the incidence of vasospasm     following a SAH event treated by vascular clipping. To determine if Procrit® administration     prior to aneurysm clipping in patients with Aneurysmal SAH will improve neurological     assessment scores in the post-SAH/post-clipping time period. To determine the feasibility of     organizing a larger, randomized study to explore the neuroprotective effect of Procrit® in     patients with Aneurysmal SubArachnoid Hemorrhage (SAH) when Procrit® is administered prior to     surgical clipping of the aneurysm.      It is hypothesized that Procrit will provide a significant level of neuroprotection in the     brain after an SAH event as a result of reduced cell death, as well as a reduced amount of     vasospasm activity and delayed cerebral ischemia which can occur as a result of SAH. These     factors may contribute to improved neurological functioning scores when compared to the     placebo treated patients.   "
212612|NCT00626587|"     The diagnosis of peripheral pulmonary lesions(PPLs) remained a clinical challenge for     physicians. Bronchoscope with sampling procedures was recognized as a useful method to obtain     the correct diagnosis of PPLs. Conventional diagnostic procedures included transbronchial     biopsy(TBB), bronchial washing(BW), or bronchial brushing, but the diagnostic yields were     sometimes suboptimal. The diagnostic role of TBNA for PPLs remained to be determined, since     many of the published studies were retrospective and had small sample size. This may explain     the fact that TBNA was always underutilized for PPLs by bronchologists. With the popular     application of EBUS-guided procedures in clinical setting, we performed EBUS-guided TBNA for     PPLs. We want to determine whether EBUS-guided TBNA can improve the diagnostic rate of PPLs.   "
212613|NCT00626600|"     Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with     severe cancer pain.   "
212614|NCT00626613|"     To evaluate the relationship between Risperidone Treatment, Treatment Discontinuation Rate,     and Quality of Life of patients with Alzheimer's Disease and BPSD.   "
212615|NCT00626626|"     Allogeneic hematopoietic transplant is curative for many patients with hematological     neoplasms but conditions to provide optimal engraftment and anti-tumor efficacy with minimal     toxicity are still under way. Clofarabine is a newly licensed agent with dramatic     anti-leukemic activity. Its incorporation into a regimen for pre-transplant conditioning of     acute leukemia and lymphoma patients is logical, exploiting both the anti-tumor activities it     is recognized to have and the immunosuppressive activity seen with drugs in its class.   "
212616|NCT00626639|"     Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in     postoperative Head and Neck setting   "
212617|NCT00626652|"     To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various     cardiovascular parameters, and safety.   "
212759|NCT00628771|"     This study will evaluate the effectiveness of CenteringPregnancy Plus, a group prenatal care     treatment program with an HIV/sexually transmitted disease prevention component, in reducing     health risk behaviors in pregnant teenagers seeking services at Community Health Centers in     the New York metropolitan area.   "
212618|NCT00626665|"     In this double-blinded, placebo-controlled, fixed-dose, study patients will be randomly     assigned to take placebo or 20 mg tadalafil thrice weekly for 6 weeks. After 6 weeks a wash     out period of 2 week will be observed and then the two groups will be switched over to     receive the other drug. We planned a priori to include 20 patients. The concomitant     medication for treatment of rheumatic disease remained unchanged during the whole study.     Patient will undergo clinical and lab evaluation for organ damage for kidney and lungs. ECHO     heart will be done at base line to assess the PAH and LV function and repeated at the end of     the study. Blood pressure will be recorded at each visit. A physician unaware of the     treatment group will record skin score and appearance of new cutaneous ulcers. The primary     outcome variables will be frequency and duration of Raynauds attacks, evolution of trophic     digital lesions and change in flow mediated dilatation of the brachial artery. Flow mediated     dilatation of the brachial artery will be done at baseline 6 and 12 weeks.   "
212619|NCT00626678|"     Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease     with unknown etiology that affects mucosa and skin of patients with significant morbidity and     mortality.      The treatment back-bone is based on prednisolone administration. There are controversies on     the opportunity of adding immunosuppressive drugs. For some, they are just corticosteroid     sparing drugs. For others, they are disease modifying drugs.      The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in     new cases of pemphigus vulgaris treated with prednisolone.   "
212620|NCT00626691|"     The goal of this study is to find out if the daily consumption of English walnuts (Juglans     regia L.) for 6 wk, at a dose readily incorporated into the diet (0.75 or 1.50 oz), will have     a positive effect on antioxidant capacity and nutrient status in a population of healthy     adults, aged 50-70 y.   "
212621|NCT00626704|"     This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed     to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with     doxorubicin alone in subjects with previously untreated, locally advanced or metastatic,     unresectable soft tissue sarcoma.   "
212622|NCT00626717|"     Background: Corneal cross linking is a procedure that induces collagen cross linking of the     corneal stroma due to release of reactive oxygen radicals upon activation of topically     applied riboflavine A by UVA exposure. This procedure might be capable of reducing     keratocouns progression.      Purpose: Although there are no randomised controlled trials on the effectiveness of corneal     cross linking for the treatment of keratoconus it gains more and more importance in the     general clinical setting. Therefore, the investigators started such randomised, placebo     controlled, double blinded, multicenter trial to find out if this treatment is as effective     as it promises to be.      Methods: Randomised, placebo controlled, double blinded, multicenter trial.   "
212915|NCT00636662|"     The purpose of this clinical study is to obtain clearance for the nasal swab sample type by     demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory     culture for Influenza A and B viruses using nasal swab samples.   "
212624|NCT00626964|"     The changes in risks of developing coronary heart disease in patients with morbid obesity     after different weight loss interventions have not been extensively studied. The primary     objective of this study is to investigate whether an intensive lifestyle intervention program     in a tertiary care clinic (Spesialsykehuset for Rehabilitering) is comparable with a 7-week     low-energy-diet followed by bariatric surgery in decreasing the risk of cardiovascular     disease in these patients.   "
212625|NCT00626977|"     The aim of the present study was to examine, for pain relief during labor, the efficacy of     two pharmacological approaches — the 0.125% ropivacaine alone and the 0.0625% ropivacaine     added to 75 ug clonidine, both by epidural administration. The effect of the drugs on mother     and newborn was also determined.   "
212626|NCT00626990|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving radiation therapy     together with temozolomide may kill more tumor cells. It is not yet known whether giving     temozolomide during and/or after radiation therapy is more effective than radiation therapy     alone in treating anaplastic glioma.      PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after     radiation therapy to see how well it works compared to radiation therapy alone in treating     patients with anaplastic glioma.   "
212627|NCT00627003|"     The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with     placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with     RLS. Also, additional objective and subjective sleep parameters and quality of life will be     assessed.   "
212628|NCT00627016|"     The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is     effective in treating patients with night heartburn.   "
212629|NCT00627029|"     This is a Congressionally mandated study. In the original study, 16 demonstration programs     provided care coordination services to beneficiaries with chronic illness in Medicare's     fee-for-service program. A five-year CMS-funded study tested whether the programs can improve     patients' use of medical services, improve patients' outcomes and satisfaction with care, and     reduce Medicare costs. The study also assessed physicians' satisfaction with the programs.      In 2008 Congress extended the project for two of the original programs--Mercy Medical Center     - North Iowa and Health Quality Partners in Pennsylvania--and they will enroll Medicare     beneficiaries and provide care coordination services into the spring of 2010.   "
212630|NCT00627042|"     A study to determine how long ramucirumab (IMC-1121B) will stop cancer from growing in     participants with liver cancer that cannot be treated with surgery.   "
212631|NCT00627055|"     To evaluate the efficacy and safety at 48 weeks between LPV/r monotherapy and 2 NRTIs + LPV/r     therapy in patients failing a standard NNRTI-based treatment regimen. Also, to evaluate the     short-term 24-week efficacy and safety of Lopinavir/ritonavir (LPV/r) monotherapy and 2     NRTIs+LPV/r therapy in patients failing a standard NNRTI-based treatment regimen as an     interim analyses when 50% of the patients in each arm have reached 24 weeks after     randomization. Last, to define risk factors for monotherapy failure in HIV-treated     individuals      Hypothesis. The rate of virologic suppression is not inferior in the monotherapy arm.   "
212633|NCT00627081|"     The association of general anesthesia and of thoracic epidural anesthesia is used in thoracic     surgery with a demonstrated benefit on the risk of postoperative respiratory complications.      The objective of the study is to analyze the influence of thoracic epidural administration of     chirocaine (5 mg/ml) on the administration of anesthetic agents (propofol and remifentanil),     these drugs being administrated using a closed-loop system with the Bispectral Index as the     controller.      Two groups of patients are compared:        -  one group will receive general anesthesia and thoracic epidural administration of          saline. Chirocaine will be administered before patient's awakening,        -  one group will receive general anesthesia and thoracic epidural administration of          chirocaine (5 mg/ml).      In both groups, the closed-loop system ensures that le depth of anesthesia is similar in both     groups.   "
212634|NCT00627094|"     The objective of this investigation is to demonstrate the effectiveness and safety of Biatain     Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.   "
212635|NCT00627107|"     The ReWalk enables people with lower limb disabilities to carry out routine ambulatory     functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such     as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other     severe walking impairments. The device promises to restore the dignity of disabled persons,     enabling them to work and improve their general health and quality of life, as well as     significantly reduce medical and other related expenses.   "
212636|NCT00627120|"     To assess the safety and tolerability of a single dose of VGX-1027 in the range of 1-800mg.   "
212637|NCT00627133|"     Pilot study to evaluate efficacy of Keppra (levetiracetam) for seizure control in patients     with alcohol related seizures.   "
212638|NCT00627146|"     Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of     beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical     onset of disease that persists until 48 months after administration.      The investigators also hypothesize that in type 1 diabetic patients with recent clinical     onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18     and 48 months after administration, based on assessment of clinical and laboratory adverse     events.   "
212639|NCT00627159|"     Research has shown that the presence of heart disease and stroke is higher in the Indo-Asian     population compared to other ethno-cultural groups. This may be due to multiple reasons such     as a higher presence of diabetes, high blood pressure, high cholesterol, obesity, and lower     levels of physical activity.      This program will bring together the Calgary Indo-Central-Asian communities and the Calgary     Healthcare community to help reduce the rate of heart disease and stroke through a     supportive, culturally-sensitive program that is community-based through the following steps:        1. Increase awareness of heart disease and stroke through education among the Calgary          Indo-Central-Asian population.        2. Identify early, the risk factors related to heart disease and stroke through screening          programs.        3. Provide appropriate follow-up care to the population at risk for heart disease and          stroke.   "
212640|NCT00627172|"     Multislice CT angiography is a novel but already established and widely used in diagnosing     coronary artery disease (CAD). It is very reliable in ruling out hemodynamically significant     narrowings in coronary arteries (Negative predictive value). However, it may overestimate the     severity of the stenoses in up to 30% of the coronary artery lesions (positive predictive     value 70%). However, when coupled with a functional or flow-sensitive diagnostic test, such     as PET perfusion or coronary doppler ultrasonography, one can assume that even the PPV may be     as high as 95 %. Despite this assumption, there`s no scientific evidence to support use of     such hybrid multi-modality tests at present.      The investigators hypothesis is that improving the diagnostic accuracy of non-invasive     diagnosis of coronary artery disease will decrease the proportion of patients that need     catheter angiographies. The avoidance of these unnecessary invasive procedures will improve     patients´ quality of life and may even redirect health care resources in a more efficient     way.   "
212641|NCT00627185|"     This is a randomized, controlled trial (RCT) to test the efficacy of an internet continuing     dental education intervention designed to increase tobacco cessation counseling in dental     practices. The intervention involves surveying practices regarding preventive care, surveying     adult patients about their tobacco habits and preventive care provided by dental practice and     training/educating the dentist and office staff on tobacco cessation. With patients who smoke     and indicate that they have quit, we followed up with testing their saliva for the presence     of cotinine. We have enrolled general dentists and periodontists who practice in the     Southeastern United States.   "
212642|NCT00627198|"     This is an open-label, phase II study evaluating the safety and efficacy of PTK787/ZK222584     administered daily in subjects with neuroendocrine tumors that are experiencing progressive     disease and/or whose tumor-related syndrome symptoms (flushing and diarrhea) are considered     inadequately controlled despite optimal doses of octreotide therapy. Inadequate control is     defined as a minimum of 2 flushing episodes or 6 bowel movements per day for 7 consecutive     days. Subjects who meet all inclusion and exclusion criteria and have completed all baseline     and screening testing will receive an initial dose of PTK787/ZK222584 1,250 mg once daily and     subjects will also remain on the scheduled doses of Sandostatin LAR 30 mg every 4 weeks. Both     drugs will be dosed on a flat schedule of mg, not by weight or body surface area. The     PTK787/ZK222584 medication will be taken orally with daily dosing. Each tablet of PTK787/ZK     222584 is 250 mg. The subject will take five tablets of study medication per day 2 tabs am     and 3 tabs pm. Subjects may continue to receive therapy as long as they do not experience     unacceptable toxicities or evidence of disease progression as defined by RECIST criteria.     Subjects will be evaluated with a daily log to assess the degree of symptom control (flushing     and diarrhea) and subjects will be monitored every 2 weeks for 3 months then monthly for     biochemical control and every three months for tumor response. Subjects will be monitored by     the Investigator every two weeks for 3 months then monthly for safety and efficacy.   "
212643|NCT00627211|"     To achieve a satisfactory examination of the GI tract it needs to be distended during     endoscopic procedures. After the examinations many patients complain of abdominal pain and     discomfort. This pain has been substantially reduced by substituting room air with CO2 in     both colonoscopies and ERCPs. The use of CO2 during colonoscopy has become routine practice     at many endoscopy centers.      In our study we will test the hypothesis that abdominal pain after gastroscopies also can be     reduced by substituting room air with CO2.   "
212646|NCT00627263|"     An implantable cardioverter defibrillator (ICD) is a small device that is implanted in the     chest and uses electrical shocks to control arrhythmias, which are abnormal heart rhythms.     Arrhythmias can be caused by many factors, including stress and anger. This study will     evaluate the use of a stress reduction treatment (SRT) program aimed at reducing the     occurrence of arrhythmias that require treatment with an ICD shock.   "
212647|NCT00627276|"     RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One     type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect     the growth of abnormal breast cells.      PURPOSE: This randomized pilot trial is studying how well omega-3 fatty acids work in     treating women with newly diagnosed ductal carcinoma in situ and/or atypical ductal     hyperplasia.   "
212648|NCT00627289|"     Chronic postherniotomy pain affects every day activities in 5-8% of patients. However, no     established treatment for this pain syndrome exists and previous reports on the effect of     surgical intervention suffer from methodological problems. The neurophysiological     characteristics suggest that pain arises from deeper neuronal structures injured during     surgery or by ongoing inflammation from the mesh. This study investigates the effect of     removing inserted mesh and compressed nerves on pain related daily impairment of activities     assessed by the validated AAS questionnaire before and 6 months after surgery   "
212649|NCT00627302|"     To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.   "
212650|NCT00627315|"     This project will study the effects of surgery for obesity on bone metabolism and hormones     that regulate appetite.   "
212651|NCT00627328|"     Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker     patients with and without previously diagnosed AT.   "
212652|NCT00627341|"     This study will compare the effectiveness of two types of psychotherapy, a relapse prevention     program and cognitive behavioral therapy, in reducing relapse and fear of eating situations     in people with anorexia nervosa.   "
212653|NCT00627354|"     RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, etoposide, and vinorelbine, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. It is not yet known which drug is more effective in killing     tumor cells.      PURPOSE: This randomized phase II trial is studying how well mitoxantrone works compared to     etoposide or vinorelbine works as second-line therapy in treating patients with metastatic     prostate cancer that did not respond to hormone therapy.   "
212654|NCT00627367|"     Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an     additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and     no more adverse events than patients receiving non-protocolized pain management.   "
213134|NCT00641069|"     To evaluate the effect of use of automated chest compression device on blood pressure in     patients presenting with cardiac arrest. Higher systolic, diastolic and mean blood pressures     are expected.   "
212655|NCT00627380|"     We are testing the safety and efficacy of a 16-wk yoga lifestyle intervention on oral glucose     tolerance, fasting lipid/lipoprotein levels, body composition, cardiovascular function,     quality of life, CD4+ T-cell counts and viral load in HIV-infected men and women with     components of The Metabolic Syndrome. We hypothesize that a yoga lifestyle intervention will     improve metabolic, anthropometric, cardiovascular disease parameters, and quality of life     domains without adversely affecting immune or virologic status in people living with HIV.   "
212656|NCT00627393|"     Neutropenia, a condition characterized by an abnormally low number of infection-fighting     white blood cells called neutrophils, commonly develops in people who have undergone     chemotherapy or hematopoietic stem cell (HSC) transplantation. The severely reduced immunity     of those with neutropenia can put them at risk of entry of life-threatening infections,     making the implementation of treatments that increase white blood cell numbers important.     Several studies have shown that the transfusion of donor granulocytes, a type of white blood     cell that includes neutrophils, is effective in promoting the recovery of adequate numbers of     granulocytes. However, granulocyte transfusions can cause side effects, and it is not known     whether the success of the therapy outweighs the health risks of the side effects. This study     will evaluate the safety and effectiveness of granulocyte transfusions in treating people     with a bacterial or fungal infection during neutropenia.   "
212657|NCT00627406|"     The purpose of this study is to possibly further improve the clinical outcome and explore the     incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in     GnRH antagonist IVF/ICSI cycles   "
212658|NCT00627419|"     To evaluate the antitumor activity of IPI-504 in patients with metastatic melanoma.   "
212659|NCT00627432|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well giving gemcitabine together with     oxaliplatin works compared to gemcitabine alone in treating patients with locally advanced or     metastatic bladder cancer.   "
212660|NCT00627445|"     This trial is conducted in Asia. The trial aims to investigate if the blood glucose control     of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin     aspart 30 both in combination with metformin.   "
212661|NCT00627458|"     The purpose of this booster study is to evaluate, in subjects primed in the primary study     106786, the persistence, at the time of the booster vaccination, of antibodies elicited by     the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will     also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This     protocol posting deals with the objectives and outcome measures of the booster phase. The     objectives and outcomes measures of the primary phase are presented in a separate protocol     posting (NCT = 00376779).   "
212662|NCT00627471|"     To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with     insulin glargine on an algorithm with insulin naive patients starting with insulin glargine     on the physician's standard practice.      To compare in terms of FBG insulin naïve patients starting with insulin glargine on an     algorithm with insulin naïve patients starting with insulin glargine on the physician's     standard practice.      To compare the percentage of patients achieving HbA1c< 7% in each treatment group.      To compare hypoglycaemic events (minor, severe and nocturnal) between groups.      To compare average insulin dose between groups.      To compare PRO (patients' reported outcomes) between groups.      To compare mean changes in body weight between treatment groups.   "
212663|NCT00627484|"     This study is designed to compare the changes in insulin sensitivity as well as     gastrointestinal hormone levels in diabetic and non-diabetic obese individuals who are     undergoing weight loss procedures. The main hypothesis of this study is that weight loss     induced by gastric bypass will induce a greater improvement in insulin sensitivity compared     with gastric banding or low calorie diet. Subjects will be studied before and after weight     loss. Studies consist of intravenous glucose tolerance test, body composition analysis, meal     test, and energy expenditure.   "
212664|NCT00627497|"     The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM     Spinal Stabilization System as a method of treating patients with symptoms of degenerative     lumbar spinal stenosis at a single level from L2 to L5.   "
212665|NCT00627510|"     Compliance with treatment is notoriously low in psychiatric patients. Traditional methods of     monitoring compliance, however, may underreport nonadherence to treatment. In this study,     actual plasma levels at admission - which are ROUTINELY taken at the Dept Psychiatry of the     Paracelsus Medical University - were compared to plasma levels that can be expected from the     prescribed preadmission dosing regimen. This was done to give treating psychiatrists a     quantitatively precise idea of how frequently they can expect their patients to have plasma     levels that are below the level of medication as intended by the prescribing physician.   "
212666|NCT00627523|"     To demonstrate the effect on height and psychomotor development of Growth Hormone treatment     in very young children starting at an age of 2 years.   "
212667|NCT00627536|"     This study was undertaken to investigate the scar-improvement efficacy and safety of a single     dose of avotermin (Juvista) injection into skin incisions.   "
212668|NCT00627549|"     Summary:      Vaginal prolapse is a well-known disease and is observed in approximately 11% of all     postmenopausal women and tending to increase with age. Consequently, many surgical procedures     have been developed in order to ensure sufficient support for the bladder, rectum or vaginal     vault depending on the site of the defect. However, many procedures are associated with a     high recurrence rate up to 40 % even within one to two years after the surgical procedure.      Due to the high recurrence rate new methods include the use of mesh, either biologically or     synthetic. The latter is a permanent implant and therefore theoretically may result in a     long-lasting anatomically correct position of the prolapse.      Although the recurrence rate may be lower using a mesh such surgical procedures may be     associated with adverse events such as erosions of the vaginal mucosa. Others have observed     shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used.     In contrast the recurrence rate is lowered up to 25%.      The above-mentioned advantage of synthetic mesh is however, mostly based on few     non-randomised studies. We therefore find it of importance to evaluate whether a surgical     procedure using a mesh implant is superior to conventional surgical techniques. The present     study is a clinical controlled study where patients with anterior vaginal prolapse are     randomised to either a mesh technique or a standard anterior procedure.      The present study includes only two more visits at the outpatient clinic after the surgical     procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and     faecal leakage and sexual habits.      Any participation in the study is totally voluntary and the patient may at any time withdraw     herself. In any case the patient will receive our standard treatment.      The study is performed in all the Scandinavian countries.   "
212669|NCT00627562|"     1. Patients included will have benign or malignant lesions with treatment plan for          endoscopic resection or resection by other minimally invasive techniques.        2. They will be offered a robotic approach to their surgery using the DaVinci robotic          surgical system (intuitive Surgical, Inc.).        3. The objectives are to evaluate our ability to adequately visualize the surgical field          and perform the intended surgery without a higher complication rate.        4. Secondary objective include evaluation of blood loss, length of hospital stay,          complications while using the DaVinci robot system, and quality of life in subjects and          historical controls undergoing similar surgery without the robot or radiation therapy.        5. To evaluate recurrence, survival and other outcome data in robotic surgery patients          compared with similar historical control groups (matched with respect to stage, prior          and subsequent treatment, age, tumor HPV positivity) of patients who have undergone          standard surgery without the robot or radiation/chemoradiation treatment as an          alternative to surgery.      5. Endpoints will be compared to historical controls.   "
212670|NCT00627575|"     This study will evaluate the amount of the cholesterol-lowering drug atorvastatin available     in the bloodstream, when taken together with the anti-seizure drugs lamotrigine or phenytoin.   "
212671|NCT00627588|"     The primary objectives of the trial are to assess the safety and efficacy of ProSavin.      Patients in the trial will have been diagnosed with Parkinson's disease and will be failing     on current treatment with L-DOPA but they will not have progressed to drug-induced     dyskinesias. The first stage is an open-label dose escalation to evaluate up to three dose     levels of ProSavin in cohorts of three patients each. Following a recommendation by the DMC     the study may proceed to the second stage of the trial, a further 12 patients will be     recruited to confirm efficacy of the optimal dose in the randomized phase of the study.      The efficacy of ProSavin will be assessed using the Unified Parkinson's Disease Rating Score     (UPDRS). Patients will be monitored at regular intervals, with the primary endpoint being an     efficacy assessment at six months after treatment. The secondary objective of the trial is to     asses the extent to which patients' current therapy (L-DOPA) can be reduced following     administration of ProSavin.   "
212672|NCT00627614|"     RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an     effective method of diagnosing breast cancer.      PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in     diagnosing breast masses in women with a breast mass or breast cancer.   "
212673|NCT00627627|"     To evaluate the antitumor activity following treatment with IPI-504 in patients with breast     cancer.   "
212674|NCT00627640|"     Parkinson's Disease is a major neurodegenerative disorder in which there is a progressive     loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA)     deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that     crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the     major DA metabolising enzyme in man.      Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and     safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a     stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease.      The principal efficacy measure is the increase in mean daily on time during the 18-hr diary     recording period.   "
212675|NCT00627653|"     The purpose of this study is to determine if treatment with a drug called fenofibrate, which     is a PPAR-alpha agonist and controls how the heart metabolizes fats, will reverse the     age-related decline in cardiac fat metabolism and mechanical function.   "
212676|NCT00627666|"     RATIONALE: Giving chemotherapy before a donor bone marrow stem cell transplant helps stop the     growth of cancer cells. Chemotherapy and antithymocyte globulin stop the patient's immune     system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor     effect). Sometimes the transplanted cells from a donor can also make an immune response     against the body's normal cells. Giving cyclosporine and methotrexate after transplant may     stop this from happening.      PURPOSE: This phase II trial is studying how well giving donor stem cell transplant together     with busulfan, fludarabine, and antithymocyte globulin works in treating patients with     hematological cancer.   "
212677|NCT00627679|"     The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses     of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy     volunteers.   "
212678|NCT00627692|"     The purpose of this study is to determine whether prucalopride is safe and effective in the     treatment of constipation in elderly subjects living in a nursing facility.      Hypothesis:      Prucalopride up to a dose of 4 mg once daily is safe and well tolerated in in elderly     subjects living in a nursing facility.   "
212679|NCT00627705|"     The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC)     in children with Autism. NAC is a compound that increases the levels of Glutathione, the     body's main antioxidant. Glutathione is a compound in the blood that is part of a natural     defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by     internal toxins called free radicals. It is possible that children with Autism tend to have     lower levels of glutathione, an important compound in our bodies that helps combat the     effects of toxic free radicals.      We hope that by studying the antioxidant system in more detail, we will increase our     understanding of the reasons why people develop Autism so that we can design better ways to     treat individuals with this condition. This study is meant to test the safety tolerability of     NAC and its effectiveness in the treatment of behavioral difficulties in children with     autism. It will also examine the possible benefit of this agent in improving the core     deficits in autism such as social deficits.   "
212689|NCT00627835|"     The purpose of this study is to assess the safety and determine MTD (maximal tolerated doses)     and recommended doses of neoadjuvant sorafenib (BAY 43-9006) and concurrent sorafenib,     cisplatin and radiation in the locally advanced squamous cell carcinomas of the head and neck     (SCCHN)patient population.   "
212690|NCT00627848|"     The purpose of the study is to investigate the effect of rivastigmine given as an acute dose     compared to placebo and after 1 month chronic dosing on fMRI response during a face     recognition task. Furthermore, the aim is to investigate whether fMRI response is correlated     with long term treatment effect at 6 months and 12 months.   "
212680|NCT00627718|"     Age Related Macular Degeneration (ARMD) is the most common cause of irreversible blindness in     people of age 50 or older in the western populations. ARMD has two forms, the wet and the dry     forms. The wet form is more serious and can lead to irreversible loss of vision. In the wet     form of ARMD, new blood vessels grow under the retina. These blood vessels leak blood and     fluid and cause the retina and the macula to swell. So the thickness of the macula increases.      One of the key factors in the treatment of wet ARMD is early diagnosis and treatment to     prevent complete visual loss. In this research, we are going to use a technique, called the     Heidelberg retinal tomograph (HRT) to measure and compare the thickness of the macula in     healthy controls and in patients suspected of having ARMD. HRT is a non-invasive imaging     system that uses laser to measure the thickness of the macula. This allows us to come up with     a quite simple and easy-to-use technique that helps us to diagnose wet ARMD early and treat     it before visual acuity is completely lost.   "
212681|NCT00627731|"     A comparison of oral prednisolone administration with intravenous methylprednisolone infusion     in the treatment of acute asthma exacerbation in hospitalized patients. Oral     glucocorticosteroids administration may be effective as intravenous high-dose     methylprednisolone infusion.   "
212682|NCT00627744|"     A three months, double-blind, randomised, parallel-group study evaluating the efficacy of     sitagliptin (Januvia™) versus placebo on beta-cell function in patients with newly detected     glucose abnormalities and acute myocardial infarction or unstable angina pectoris.      Primary endpoint Improvement in beta-cell function measured by means of the insulinogenic     index (ΔI30/ΔG30) obtained from an oral glucose tolerance test (OGTT).      Secondary endpoints        1. Improvement of glucose tolerance by means of an OGTT        2. Improvement in endothelial function        3. Improvement in incretin-independent beta-cell function measured as the Acute Insulin          Response (ΔAIRG) during an intravenous glucose tolerance test   "
212683|NCT00627757|"     The purpose of the study is to determine whether antipsychotic treatment is influence     psychiatric patients due to endocrine and metabolic status and a quality of life.      The investigators expect, that 30-50% of patients will show pharmacon - gene induced weight     gain (> 7% of initial bodyweight) while the rest of patients will maintain unaltered     bodyweight.   "
212684|NCT00627770|"     The purpose of this study is to evaluate the applicability and measurement properties of     bioimpedance spectroscopy for postsurgical edema assessment after total knee arthroplasty   "
212685|NCT00627783|"     DYNAMIT is a prospective, randomized, multicenter, open strategy trial run in 45 French     hospitals. Diabetic patients with no evidence of coronary artery disease and at least 2     additional cardiovascular risk factors are randomized to screening for silent ischemia using     a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N=316),     or follow-up without screening (N=315). All have access to cardiovascular prevention     according current guidelines. The main end point is time to death from all causes, non-fatal     myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or     emergency service intervention.   "
212699|NCT00627978|"     Primary Objectives        -  Assess ultrastructure changes in dermal myelinated nerves of patients who receive          ixabepilone chemotherapy        -  Detailed characterization of peripheral neuropathy in patients who receive ixabepilone      Secondary Objectives        -  Clinical benefit rate        -  Time to progression ( TTP)        -  Toxicity        -  Exploratory studies:             -  Relation of MDR 1 and TRKA polymorphisms to evolution of ultrastructural neurologic               changes observed in neurons.             -  Relation of NGF, IL8, and IL10 to the development of clinical symptoms and               ultrastructural changes in neurons.   "
212714|NCT00628173|"     Purpose:To compare the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation in the     superior versus inferior quadrants.      Methods: In a non-randomized clinical trial and over a period of two years, consecutive     patients with refractory glaucoma underwent AGV implantation in the superior or inferior     quadrants. Main outcome measures included best corrected visual acuity (BCVA), intraocular     pressure (IOP), number of glaucoma medications, complications and success rate (defined as at     least 30% IOP reduction below preoperative values and 5<IOP<22 mmHg with or without glaucoma     medications). Other criteria for failure included implant removal, additional glaucoma     surgery, phthisis bulbi or loss of light perception.   "
212686|NCT00627796|"     Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg     was developed in order to further extend the duration of the release of the active     ingredient. The ATG formulation consists of a solution of lanreotide in water with no     additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg     doses and provided a prolonged dosing interval and good tolerability (1). In some previous     studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as     octreotide-LAR in patients with acromegaly (4-7).      Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking.     Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This     information is particularly useful in the setting of first-line therapy of acromegaly that is     currently becoming a more frequent approach to the disease (8). It is demonstrated that     approximately 80% of the patients treated with depot somatostatin analogues as first line     have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A     definition of significant tumor shrinkage was provided in 14 studies (including a total     number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of     patients receiving first-line somatostatin analogues therapy for acromegaly had a significant     reduction in tumor size (10). About 50% of the patients were found to have a greater than 50%     tumor shrinkage within the first year of treatment (10); in this study we found that percent     decrease in IGF-I levels was the major determinant of tumor shrinkage (10).      The current open, prospective study is designed to investigate the prevalence and amount of     tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.   "
212687|NCT00627809|"     The investigators hypothesized that complementary intracoronary streptokinase administration     to primary percutaneous intervention in patients with acute myocardial infarction may provide     limitation infarct size and improvement in left ventricular volumes and function in acute and     late phases (6 months).   "
212688|NCT00627822|"     The purpose of this study is to assess patient and companion acceptability of medical     education in a non-teaching private hospital   "
212691|NCT00627861|"     Antihypertensive drug treatment is effective in only about 50% of patients. One mechanism     responsible for treatment failure is a drug related stimulation of the     renin-angiotension-aldosterone-system (RAAS). Several classes of medications that treat     hypertension by blocking the RAAS system have been developed. However, the kidney responds to     these drug treatments by producing greater amounts of renin. This high level of renin can     reduce the effectiveness of some of these medications, ultimately causing the blood pressure     to rise. This is one reason why blood pressure can be difficult to control in a certain     percentage of patients.      The hypothesis to be tested in the proposed study is that beta-adrenergic blockade     (β-blockade), when superimposed upon aliskiren, a drug that competitively inhibits plasma     renin activity (PRA) but stimulates the release of renin by the kidneys (plasma renin     concentration [PRC]), can suppress the reactive increase in PRC that occurs during aliskiren     monotherapy.      The primary aim of this study is to measure plasma renin concentration (PRC) and plasma renin     activity (PRA) levels during renin inhibition with aliskiren and combined renin     inhibition/β-blocker treatment to determine whether the addition of a β-blocker attenuates     the rise in plasma renin concentration (PRC). A secondary aim is to determine whether     combined treatment further suppresses PRA and blood pressure.   "
212692|NCT00627874|"     The purpose of this study is to assess whether a short-term imposed myopic defocus is     effective in preventing the development and progression of juvenile-onset myopia in Chinese     children.   "
212693|NCT00627887|"     The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is     safe and effective in relapse prevention of depression.   "
212694|NCT00627900|"     Since the advent of coronary stents, in-stent restenosis has proven to be the major     limitation of interventional cardiology, occurring in as many as 30% of patients.     Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis.     They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer,     and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel     wall and stops the process of neointimal hyperplasia, thereby significantly reducing the     incidence of in-stent restenosis.      The study Prevention of Coronary Restenosis examines the effectiveness of sirolimus-eluting     stents (SES) compared to bare-metal stents (BMS) in patients with coronary stenosis. The goal     of the study is to examine whether the guideline-supported implantation of SES, despite the     higher initial cost, improves the quality and economic outcomes of the treatment of patients     with coronary stenosis. Secondarily, the study evaluates patient quality of life, impairment     of daily activities, re-intervention rate, as well as an account of the utilisation and     benefits of the implemented standardised guidelines.      In this prospective, multi-centre, country-wide cohort study, 658 patients undergoing an     implantation of a SES for treatment of coronary stenosis were recruited from 35 hospital     centres. Their treatment and outcomes will be evaluated over a 3-year period by means of     standardised questionnaires. In addition, information obtained from the patients will be     confirmed and augmented by telephone interviews with the attending physicians involved in     their follow-up care.      In order to appraise the effect of the new therapy, a comparison cohort group of 394 patients     receiving a BMS was recruited. These patients will be evaluated and observed by the same     method as those patients receiving a drug-eluting stent, also over 3 years   "
212695|NCT00627913|"     In this study, the investigators plan to compare the incidence and complications of     intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients taking     tamsulosin (Flomax) and treated with retrobulbar injection of anesthesia, versus injection of     Healon 5 viscoelastic into the anterior chamber.   "
212696|NCT00627926|"     A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in     combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).   "
212697|NCT00627952|"     Eight-week multi-national, multicenter, randomized, double blind, active control, two arms,     parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase     followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril)     phase.   "
212698|NCT00627965|"     The purpose of this study is to determine whether regular oral use of sildenafil citrate can     prevent or attenuate high altitude illnesses.   "
212700|NCT00627991|"     Patients who are suffering from a stroke often present to the hospital with elevated blood     pressure. Elevated blood pressure in the setting of stroke increases the risk of brain     swelling or bleeding into the brain. Even so, there has been concern about lowering the blood     pressure with medications because the newly injured parts of the brain may not get the blood     flow they need, thereby worsening the damage from the initial stroke. We hope to demonstrate     that the drug valsartan can be used safely and modestly to lower blood pressure in acute     stroke patients, without having a detrimental effect on brain blood flow or neurologic     status. Novel MRI techniques to measure brain blood flow will be used in conjunction with     clinical scales to demonstrate safety.   "
212701|NCT00628004|"     The objective of this open label extension study (extension to study DK143WS) is to evaluate     the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety     follow-up period.   "
212702|NCT00628017|"     This preliminary study is aimed to investigate whether it is feasible to conduct a study to     use fish oil compared to the placebo(olive oil) in people with cognitive impairment. We will     also explore whether fish oil has better efficacy in some clinical aspects in people with     cognitive impairment during 24 weeks intervention. The major clinical outcome will be:        1. general clinical impression        2. cognitive function   "
212703|NCT00628030|"     The percentage of overweight children between the ages of 6 and 11 has nearly tripled in the     last three decades, and rates are even higher among African Americans.Overweight children are     at-risk for numerous health problems, thus effective treatments are urgently needed. This     study will evaluate an innovative intervention for ethnically diverse parents (NOURISH),     which focuses on helping parents role model and teach their children healthy behaviors.   "
212704|NCT00628043|"     This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU     compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to     anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.   "
212705|NCT00628056|"     Diabetes increases the risk of heart failure. This is mainly due to a disease of the blood     vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may     also contribute. We plan to study the mechanisms involved in this abnormal metabolism, whilst     also assessing the effects of a drug called Perhexiline which improves the abnormal     metabolism that is present in diabetic patients before the development of heart failure.   "
212706|NCT00628069|"     Based on the motor learning theories, it is hypothesized that bench-model training will allow     junior residents to be more interactive than trainees lacking similar active hands-on     training.   "
212707|NCT00628082|"     Up to half of all patients with heart failure are found to have normal pumping function of     the heart muscle, but show abnormalities in the way the heart muscle relaxes and fills with     blood. These patients often have high blood pressure, and tend to have stiff arteries and     stiff heart muscle. We wish to test the hypothesis that these patients have abnormal energy     stores in their heart muscle.   "
212708|NCT00628095|"     CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells.     Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18     that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped     that taking this drug will reduce the symptoms of rheumatoid arthritis   "
212709|NCT00628108|"     To determine the safety of levocetirizine in children ages 6-11 months with symptoms of     allergic rhinitis or chronic idiopathic urticaria.   "
212710|NCT00628121|"     GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in     healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when     administered in a single dose have been investigated in studies conducted using doses of 1, 3     and 5 mg. Studies performed in premenopausal female volunteers confirmed that cetrorelix     rapidly suppresses luteinizing hormone (LH) and estradiol and shows dose-dependent     prolongation of the duration of LH suppression. However, there have been few reports of     studies of the relationship between the cetrorelix dosage and its effect on LH surge. In the     present study, we investigated the effect of cetrorelix on LH surge when this drug was     administered in single doses of 1, 2 and 3 mg.   "
212711|NCT00628134|"     Inhaled medications are often used to treat lung diseases such as cystic fibrosis. We are     performing this study to determine whether inhaled medications dissolved in surfactant-based     solutions will distribute more evenly throughout the lungs when compared to standard     saline-based solutions. We think that inhaling medication that is in a surfactant-based     liquid will result in more medication reaching partially blocked parts of the lung. This     study will use a special nuclear medicine test called an aerosol deposition scan to compare     how a drug spreads in the lung using a surfactant-based aerosol compared to a saline-based     aerosol.   "
212712|NCT00628147|"     The purpose of the study is to determine if colonoscopic examination using a colonoscope with     a narrow band imaging light is more effective at detecting polyps compared to a colonoscope     with standard full spectrum white light.   "
212713|NCT00628160|"     Septic shock is a frequent and severe complication in cirrhosis. Current mortality rate     ranges between 50 and 80% of cases. Refractory shock, hepatorenal failure and variceal     bleeding are the main causes of death of these patients. Terlipressin administration could     prevent these complications and improve survival in this setting.      Aim: To evaluate the effects of terlipressin administration on hospital survival in cirrhotic     patients with severe sepsis or septic shock.      Methods: Prospective, open labelled, controlled trial evaluating 72 cirrhotic patients with     severe sepsis or septic shock who will be randomized to receive terlipressin plus     alpha-adrenergic drugs or only alpha-adrenergic drugs at shock diagnosis. Patients will be     submitted to continuous systemic hemodynamic monitoring (S. Ganz catheter or Vigileo).     Changes in vasoactive systems and cytokines levels will be also evaluated.   "
212715|NCT00628186|"     The purpose of this study is to determine which stent type is effective in the decrease of     postoperative stay and complications across pancreaticojejunostomy after     pancreaticoduodenectomy.   "
212716|NCT00628199|"     This is a research study in which your cells will be used for somatic cell nuclear transfer     (SCNT), and/or genetic reprogramming research which may result in the production of stem cell     lines. This study does not provide treatment.   "
212717|NCT00628212|"     The purpose of this study is to evaluate the efficacy and safety and to determine the     appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with     type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration     once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment     manner.   "
212718|NCT00628225|"     Background: Smoking cessation is the key element in the treatment of patients with Chronic     Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these     patients with successful quitting smoking was suboptimal. Therefore we evaluated the     effectiveness of two smoking cessation programs (counseling and nicotine replacement) for     smokers with COPD in routine general practice, one with (CNB) and one without (CN) the     combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD     symptoms in successful smoking cessation.      Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The     usual care group (UC) consisted of 148 patients (22 practices), the first intervention group     (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second     intervention group of 276 patients (25 practices. Main outcome measure was (biochemically     verified) point prevalence.   "
212719|NCT00628238|"     The study is a two-arm, multi-center trial of Revlimid® and Rituximab, for the frontline     treatment of patients with Chronic Lymphocytic Leukemia (CLL) designed and conducted by the     CLL Research Consortium (CRC). The purpose of this study is to determine the response rate of     the combination of Revlimid® and Rituximab in previously untreated CLL patients in two arms-     those aged 65 years and above and those younger than 65. Secondary objectives will evaluate     the safety of the combination of Revlimid® and Rituximab, response duration, improvement in     hematologic parameters, and the significance of the tumor flare reaction. All patients will     have assessment of known prognostic factors for CLL as well as novel prognostic factors will     be evaluated for predicting response to treatment. Biologic corollary studies are designed to     evaluate the mechanism of Revlimid® in CLL and the combination of Revlimid® and Rituximab.   "
212720|NCT00628251|"     The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281     against liposomal doxorubicin to see which is effective and well tolerated in treating     patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed     previous platinum therapy.   "
212721|NCT00628264|"     The purpose of the present research study is to investigate for the first time, the safety     and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary     bypass graft and/or valve repair or replacement surgery. AP214, the investigational drug, is     being developed to potentially prevent post-surgical kidney injury after thoracic aortic     aneurysm repair.   "
212722|NCT00628277|"     We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight     loss counseling would lead to a greater loss of fat mass and a greater improvement in     cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation     exercise plus counseling.   "
212723|NCT00628290|"     A controlled, randomized study on the treatment of schizophrenic psychosis with cannabidiol,     a phytocannabinoid is performed. This approach is based upon recent findings indicating that     the human endogenous cannabinoid system is significantly involved in the pathogenesis of     schizophrenia. Our group has shown, for example, that Δ9-tetrahydrocannabinol (Δ9-THC) is     able to provoke schizophrenia-like psychotic symptoms in healthy volunteers. This, as well as     the capability of Δ9-THC to exacerbate productive psychotic symptoms in schizophrenic     patients, has recently been confirmed by others. Furthermore, we found that the en-dogenous     brain constituent anandamide, an endogenous Δ9-THC agonist, is significantly elevated in the     CSF of schizophrenic patients. Cannabinergic substances such as anandamide may enhance     dopaminergic neurotrans-mission by increasing dopamine turnover. They may also influence the     onset or course of schizophrenia by as yet unidentified mechanisms We seek to investigate the     efficacy of cannabidiol in the treatment of schizophrenic and schizophreniform psy-choses,     because there is evidence that CB1 antagonists such as SR141716 and cannabidiol have     antipsychotic effects comparable to those of classic neuroleptic drugs. Furthermore,     cannabidiol is well tolerated showing few side effects in humans. Cannabidiol may serve as an     antipsychotic medication that is not primarily based upon an antidopaminergic but upon     different mechanisms, especially anticannabinergic ones. It may therefore be an effec-tive     medication in at least a subgroup of schizophrenic and schizophreniform patients and may be     expected to show additional anxiolytic effects and only minor side effects.      The control condition in this parallel design will be an established neuroleptic treatment     with amisulpride that is primarely an antidopaminergic drug. Thus, we will study not only the     antipsychotic efficacy of cannabidiol, but we will also compare the effects of both treatment     strategies on side effects and neuropsychological functioning.   "
212724|NCT00628303|"     The primary objective of this study is to assess the efficacy of motavizumab compared to     placebo when administered monthly to preterm infants during their first RSV season for the     reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd     birthdays.   "
212725|NCT00628316|"     Caffeine intake is reported by many authors to enhance the perception of tinnitus. The aim of     this study is to determine the effects of 1 month caffeine intake reduction in the scores of     validated questionnaire Tinnitus Handicap Inventory (THI) and in a visual-analog scale (VAS).   "
212726|NCT00628329|"     We wish to understand the association of Vitamin A serum levels and Vitamin A receptor number     and responsiveness in asthmatics. We believe that Vitamin A receptors may be less prevalent     in asthmatics and their responsiveness decreased.   "
212727|NCT00628342|"     This study includes patients with sleep disturbances associated with gastroesophageal reflux     disease (GERD) and has 3 treatment arms. Patients will receive only one of the following     treatment arms: esomeprazole 20 mg once daily, esomeprazole 40 mg once daily, matching     placebo once daily. The relief to the sleep disturbances will be assessed.   "
212728|NCT00628355|"     Our hypothesis is that with comparison of effectiveness of two most common techniques of     treatment for myofascial pain syndrome (injection of local anesthesia and ischemic     compression) we could choice the most adequate to treat this disease. This way we could     decrease the expenses with medicines, examinations, consultations and the time that women     remains without a diagnosis and treatment.   "
212729|NCT00628368|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients will respond to     treatment.      PURPOSE: This clinical trial is studying how well biological factors work in predicting     response to treatment in patients with esophageal cancer or rectal cancer.   "
212730|NCT00628381|"     The purpose of this study is to study the stimulating effects of prolonged (8h) enteral     L-citrulline supplementation on the normalisation of the plasma citrulline concentrations and     the Arginine-NO metabolism, the microcirculation, the systemic hemodynamics, vascular     permeability, and organ function and disease severity scores.   "
212731|NCT00628394|"     This research is being done because people with schizophrenia often have problems with     thinking including learning, remembering, paying attention, and problem solving. During this     study, we will test if cognitive remediation (computer games made to improve thinking), used     along with a drug called atomoxetine, may help the problems in thinking as well as some of     the symptoms of schizophrenia.   "
212732|NCT00628407|"     This protocol is a prospective, pilot, observational study in the Pediatric Intensive Care     Unit (PICU), Progressive Care Unit (PCU) and the Operating Room (OR) settings at the     Children's Hospital of Philadelphia (CHOP). We propose to observe, measure and report the     effect of incremental gentle sternal pressure increases on intrathoracic pressure, and other     surrogates of hemodynamic function, in stable mechanically ventilated children. This study     will provide preliminary data to inform the resuscitation research community and assist     development of evidence-based pediatric resuscitation guidelines in the future.   "
212733|NCT00628420|"     To determine the safety and tolerability of ACP-104 after oral administration of single doses     in comparison with placebo to schizophrenia or other psychotic disorders.   "
212734|NCT00628433|"     The purpose of this pilot, exploratory study is to evaluate the safety, tolerance,     pharmacokinetics and potential activity of an investigational agent, HE3286, when     administered orally, daily for 28 days to patients with mild-to-moderate ulcerative colitis.   "
212735|NCT00628446|"     This study includes male subjects age 45 to 70, who have sustained a traumatic Spinal Cord     Injury (SCI) at least 10 years prior. Subjects will be interviewed for demographic data,     including heart disease risk factors. A blood test for cholesterol levels will be drawn. A CT     scan of arteries of the heart will be performed to determine the presence of coronary     calcium, a marker of subclinical Coronary Heart Disease. Scoring of Coronary Calcium or     Coronary Calcium Score (CCS) is automated by the CT scanner. Each subject's Framingham Risk     Score will be calculated; This is an individuals 10 year risk of having a Coronary Heart     Disease event (significant symptoms). In addition, it will be determined if subjects are     being treated for diagnosed dyslipidemia (high cholesterol) according to the National     Cholesterol Educational Program (NCEP) guidelines.      The proposed pilot study aims to better understand the problem of Coronary Heart Disease in     individuals with Spinal Cord Injury, specifically CCS in SCI, when compared to the general     population.   "
212736|NCT00628459|"     Some micronutrients are likely to interact with malaria parasite, leading to either     synergistic or antagonist effect on malaria morbidity and therefore on hemoglobin response.      The purpose of this study is to investigate the effect of supplementation with iron or     multiple micronutrients on anemia while integrated with malaria management in rural Burkinabe     young anemic children with high prevalence of malaria.   "
212738|NCT00628485|"     The primary goal of the proposed study is to improve the long-term swallowing capabilities of     subjects undergoing radical or modified radical neck surgeries followed by chemoradiation     therapy (CRT), by more selective stimulation of the swallowing muscles using implanted     microstimulators called BIONs.   "
212739|NCT00628498|"     Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD.     Defibrotide is no longer available though the Emergency Use IND mechanism (also known as     compassionate use, or single patient named use). This protocol is the only mechanism by which     Defibrotide can be made available to patients in the U.S.   "
212740|NCT00628511|"     portable monitoring device could diagnose sleep apnea in high risk patients.   "
212741|NCT00628524|"     The purpose of this study is to prospectivly analyze the correlation of triglyceride     tolerance and glucose tolerance with cardiovascular morbidity and mortality in patients with     stable coronary artery disease within 18 months and to determine, whether measurement of     triglyceride tolerance can discriminate patients at risk for cardiovascular events.   "
212742|NCT00628537|"     The study looks at a new treatment for wrist and finger contractures -- a condition where the     affected hand is in a closed position, with the wrist and fingers stiff and difficult to     move from that position. We want to study if stimulation of wrist and finger muscles using an     implanted neuromuscular stimulator (BION) will be more or less effective than doing passive     exercises of the affected hand to improve the range of movement at wrist and finger joints.     Subjects of this study will be randomized into one of three groups: one doing passive     movement therapy; one receiving surface stimulation (electrical stimulation with electrodes     on the skin of the arm) and one doing BION® therapy. The passive movement group will do     therapy for 12 weeks. Subjects in either stimulation group will receive stimulation for 6     weeks and then only passive therapy for 6 weeks.   "
212743|NCT00628550|"     Cardiac arrest has a very poor prognosis, especially with prolonged efforts at resuscitation,     and unfortunately, survivors are often severely neurologically impaired. CPA in children is     often the result of a prolonged illness rather than a sudden, primary cardiac event as is     frequent in adults. This necessitates that resuscitation research must be conducted     separately for pediatric and adult patients. Authorities currently endorse the use of     epinephrine for restoring spontaneous circulation based on its ability to maintain diastolic     blood pressure and subsequent blood flow to the heart during resuscitation. However, human     studies have shown no clear survival benefit of epinephrine and have elucidated concerning     adverse effects. Recently, both the European Resuscitation Council and the American Heart     Association have recognized the use of vasopressin as a promising vasoconstrictor and an     alternative or adjunct to epinephrine in the resuscitation of adults. Vasopressin causes     profound vasoconstriction without the adverse effects of epinephrine and is associated with     improved blood flow to the heart and brain. This increased cerebral blood flow has been     associated with better neurologic outcome in animal studies. In light of compelling animal     and human studies of combined vasopressin and epinephrine, pediatric trials are indicated for     vasopressin usage in pediatric CPR. This study will evaluate the addition of the     administration of vasopressin to standard advanced CPR therapy (epinephrine alone) for     pediatric patients that experience in-intensive care unit CPA to assess for improved time to     return of spontaneous circulation (ROSC), survival to 24 hours, survival to hospital     discharge, and neurologic outcome. When a patient experiences a CPA, standard Pediatric     Advanced Life Saving (PALS) protocols as endorsed by the American Heart Association will be     initiated. This will include receiving epinephrine as the first vasopressor medication.     Patients will then be randomized to receive vasopressin (treatment group) or epinephrine     (control group) as the second vasopressor medication, if needed. If more then two doses of     vasopressor medication is required in either group, epinephrine will be administered     according to the PALS algorithm until the end of the event. All CPA events meeting inclusion     criteria will be entered into the National Registry of Cardiopulmonary Resuscitation (NRCPR)     Database, which tracts all CPA events at Children's Medical Center Dallas. Prior to     commencement of the RCT, a pilot trial of 10 patients will be completed to assess preliminary     safety, feasibility, and effectiveness of combination epinephrine-vasopressin for pediatric     in-intensive care unit CPA refractory to initial epinephrine dosing. All pilot patients will     receive vasopressin as the second vasopressor medication.   "
212744|NCT00628563|"     This is a retrospective observational study utilising anonymised individual patient clinical     and prescribing information routinely collected by UK General Practitioners (GPs). This     information will be observed for two years, one year pre and one year post- Index     Prescription Date (IPD). The IPD is the date when a patient was first switched to any option     of the step-3 asthma treatment regimen. The one year before the IPD is the baseline period     and will be reviewed for risk factors and confounding factors. The one year after the IPD is     the outcome period and will be observed to see the outcomes of the new treatment.   "
212745|NCT00628576|"     The purpose of the study was to evaluate efficacy and safety of the new acute treatment of     deep venous thrombosis by use of low-molecular-weight heparin compared with standard     treatment using unfractionated heparin, especially concerning long-term morbidity.   "
212746|NCT00628589|"     Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in     schizophrenic patients   "
212747|NCT00628602|"     Pressure ulcers (PUs) are a debilitating pathology resulting from pressure and shear in the     soft tissues of immobilized patients. In studies to date, BION neuromuscular stimulation has     been demonstrated to activate strong muscle contractions and to produce skeletal motion, with     associated increases in muscle bulk (hypertrophy), strength, and metabolic capacity, hence     counteracting the 3 major etiological factors in PU development (immobility, soft-tissue     atrophy and hypoxia).      This study intends to use neuromuscular stimulation to both shift paralyzed subjects' weight     and build up gluteal muscle volume, in order to prevent recurrence of pressure ulcers. We     will implant BIONs alongside the already exposed inferior gluteal and sciatic nerves in     patients who are undergoing gluteal rotation flap surgery for PU reconstruction. The gluteal     rotation flap is a common reconstructive technique for treating PUs by bringing healthy     muscle and skin in to repair the deficient area, and to provide healthy tissue covering over     bony prominences. The implanted BIONs will enable us subsequently to stimulate the gluteus     maximus and hip extensor muscles. Outcome measures will include tissue health variables     (measured by clinical assessment, X-Rays, MRI and Sesta-MIBI SPECT perfusion scans), pressure     redistribution (measured by an array of pressure sensors), and recurrence rates over 12     months.   "
212748|NCT00628615|"     Rationale:      The sensation of the need for urination (urge) is a complex and only partially understood     mechanism. It is our hypothesis that this mechanism is disrupted in patients suffering from     overactive bladder syndrome.      The Overactive Bladder syndrome (OAB) has been defined as a spectrum of symptoms in which     incontinence may or may not overlap with urgency, frequency and nocturia. This syndrome is     estimated to affect approximately 17% of the adult population in Europe and the United     States. The symptoms of overactive bladder have many potential causes and contributing     factors. One of these factors is an outlet obstruction of the bladder due to benign prostatic     hyperplasia (BPH). Nowadays antimuscarinic drugs are used for treatment of the overactive     bladder. Antimuscarinic agents have been proven to work slightly to moderately better than     placebo's and are associated with side effects such as a dry mouth, blurred vision and     constipation.      Many patients with lower urinary tract symptoms (LUTS) develop OAB. In this group of patients     with LUTS and OAB, there is not always a clear obstruction found. So, at least in some     patients, with LUTS, there must be another reason for OAB than obstruction.      The autonomous bladder activity has been introduced by, among others the Maastricht Urology     research group. In animal models, the bladder is shown to have rhythmic low amplitude     contractions (micro motions). It is hypothesized that this activity has a sensory function in     the micturation regulation system which is mainly located in the bladder wall. These so     called micromotions have never been demonstrated in the human bladder. The sensing function     of the bladder and the micturation reflex remain mainly unclear. We hypothesise that there is     a disregulation of the autonomous bladder activity (micro motions) in patients with OAB.      We want to explore and study the relationship between OAB, obstruction and the micro motions     in order to gain a better understanding of the bladder (patho)physiology. reason for This on     its turn, can help us in the quest for better treatment strategies for patients suffering     from OAB.      Objective:      The study is divided in two distinct groups a male and female group:      The male group consist of patients with lower urinary tract symptoms (LUTS). The female group     consist of patients with the overactive bladder syndrome OAB.      The primary objective of this pilot experiment is to describe via an observational study the     relation between non-micturation bladder activity and sensation during the filling phase of     the bladders in women. We want to explore if there is a relation between non-micturation     bladder activity and the sensation of urgency during the filling phase.      Furthermore in men, we want to study the relationship between non-micturation bladder     activity and the amount of obstruction.      We would also like to visualize the micro motions of the bladder in both men and women during     filling phase and study the influence of (visual and cognitive) stimuli on bladder activity.      We want to explore if there is a relation between non-micturation bladder activity and the     sensation of urgency during the filling phase in male patients with Lower urinary tract     symptoms. In order to gain a better understanding in bladder (patho)physiology.      Study design: A pilot observational study to describe the non-micturation bladder activity     and sensation measurement during filling phase.      Study population:      The study population consists of two groups. First a group of patients (female) who will     undergo an ambulatory urodynamic investigation to investigate their bladder complaints. All     patients will be older than 18 years.      The second group consists of male patients who will undergo a conventional urodynamic     investigation in the normal work up for their lower urinary tract symptoms. All patients will     be older than 18 years.   "
212749|NCT00628628|"     Primary Objectives:      To determine the efficacy of rasburicase administered as a single dose followed by as needed     dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm)     in the treatment of patients at high risk or potential risk for tumor lysis syndrome.      Secondary Objectives:        1. To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days        2. To evaluate the incidence of renal insufficiency and electrolyte abnormalities.        3. To determine the safety and immunogenicity of rasburicase.        4. To evaluate the cost-effectiveness of the experimental treatment (investigational arm).   "
213279|NCT00635427|"     The purpose of this study is to evaluate the long-term safety of every other week dosing of     Gene-Activated® human glucocerebrosidase (GA-GCB, velaglucerase alfa) intravenously in     patients with type 1 Gaucher disease.   "
212750|NCT00628654|"     RATIONALE: New diagnostic procedures, such as glycan analysis, may be effective in finding     ovarian epithelial cancer.      PURPOSE: This clinical trial is studying how well glycan analysis works in diagnosing cancer     in women with ovarian epithelial cancer and in healthy female participants.   "
212751|NCT00628667|"     This study looks at how effective acid suppression therapy is on symptoms associated with     chronic posterior laryngitis (CPL) in patients with documented pharyngeal acid reflux.   "
212752|NCT00628680|"     The purpose of this study is to determine if AAT-023 (Zuragen) solution is superior to     Heparin in preventing Catheter Related Blood Stream Infections for End Stage Renal Disease     patients.   "
212753|NCT00628693|"     The design of this protocol is a prospective observational study to objectively measure the     rate, depth and quality of chest compressions and ventilations delivered during cardiac     arrest in the Pediatric Intensive Care Unit (PICU) and Emergency Department (ED) settings     utilizing the MRx/Q-CPR. The data collected will be analyzed for several purposes - for     comparison with current American Heart Association (AHA) Cardiopulmonary Resuscitation (CPR)     guidelines and to determine chest wall stiffness for CPR modeling efforts and construction of     biofidelic manikins or test dummies for CPR and auto safety.   "
212754|NCT00628706|"     The purpose of this study is to determine whether THC, the main psychoactive ingredient in     cannabis, affects functional brain systems underlying memory and reward.   "
212755|NCT00628719|"     The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the     treatment of Visceral Leishmaniasis (VL) in India.   "
212756|NCT00628732|"     The purposes of this study include:        -  Determination of the change in clearance of topotecan and topotecan lactone between day          1 and day 14 for patients receiving treatment with p.o. topotecan and p.o.          cyclophosphamide x 14 days.        -  Determination of the correlation between the activity of CYP3A4, as measured by the 14C-          Erythromycin Breath Test (ERMBT), and topotecan/topotecan lactone clearance for patients          receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.        -  Determination of the response rate to oral cyclophosphamide and oral topotecan in          recurrent and/or refractory pediatric solid tumors.        -  Obtain additional safety data for the chemotherapy regimen, p.o. topotecan and p.o.          cyclophosphamide x 14 days.        -  Report the frequency of severe toxicities associated with the level of CYP3A4 activity,          as measured by the ERMBT, for patients receiving treatment with p.o. topotecan and p.o.          cyclophosphamide x 14 days.   "
212757|NCT00628745|"     THAOS is a global, multi-center, longitudinal observational survey open to all patients with     transthyretin-associated amyloidoses (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM     (cardiomyopathy) and wild-type ATTR-CM. It is open-ended with a minimum duration of 10 years.     Patients will be followed as long as they are able to participate.      The principal aims of this outcome survey are to better understand and characterize the     natural history of the disease by studying a large and heterogenous patient population.     Survey data may be used to develop new treatment guidelines and recommendations, and to     inform and educate clinicians about the management of this disease.   "
212758|NCT00628758|"     The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with     treatment according to conventional best practice in adult patients with persistent asthma.   "
212848|NCT00635765|"     The purpose of this study is to assess the safety profile of C2L-OCT-01 PR for up to an     additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study.   "
212760|NCT00628784|"     In this prospective single center study, up to 25 patients with Barrett's esophagus with LGD     or no dysplasia (Group 1), 25 patients with HGD/IMCA (Group 2), 25 patients with esophageal     carcinoma confined to the esophageal wall (Group 3) and 25 patients with severe esophageal     squamous dysplasia (Group 4) will be treated with endoscopic cryotherapy. This study is     single arm and no blinding will be utilized. Interim analysis of the data will be reviewed     with a DCI statistician after 14 patients in each group have been treated with cryotherapy     and if safety and efficacy is documented to that point in time, we will request the ability     to extend the enrollment to a maximum allowable amount of 25 patients per group. The proposed     study duration is seven years, allowing two years for patient enrollment and 5 years for post     treatment follow-up. Study duration per patient will total approximately six years.      Patients with Barrett's esophagus with no dysplasia or low grade dysplasia (group 1) will be     treated with cryotherapy at six week intervals until Barrett's mucosa is ablated or six     treatments are administered. Patients with Barrett's HGD and IMCA or severe esophageal     squamous dysplasia (groups 2 and 4) will be treated with cryotherapy at six-week intervals     until Barrett's mucosa is ablated or six treatments are administered. More advanced mass     lesions are typically more difficult to eradicate with ablative therapies and may progress     faster than patients with IMCA, therefore, patients with more advanced cancer (group 3) will     be treated every 2 weeks until the lesion is eradicated up to eight treatments.      After cryotherapy treatment is complete (i.e. the esophagus has re-epithelialized with normal     squamous epithelium for Groups 1, 2, 4 and the tumor is locally controlled/absent in Group     3), patients will be assessed by endoscopy and biopsy every three months for one year, every     six months for two years, then annually for two years (flow sheet - appendix 1; study     schedule - appendix 2).   "
212761|NCT00628797|"     Systemic scleroderma (SSc) is a rare chronic inflammatory diseae of the connective tissue     involving the skin and internal organs. To date there is no proven therapy for the skin     fibrosis available. A number of case reports and small uncontrolled cohort studies suggest     that UVA1 therapy may improve skin fibrosis. The aim of this study is therefore to     investigate whether treatment UVA1 in deed is effective in treating skin fibrosis in SSc     using a randomized, intraindividual half body irradiation protocol.   "
212762|NCT00628810|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as bevacizumab, can block tumor growth in different ways. Some block the ability of     tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by     blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab     may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy     together with bevacizumab and to see how well it works in treating patients with metastatic     colorectal cancer.   "
212763|NCT00628823|"     The main purpose of this study is to evaluate the natural history of gluten sensitivity in     endomysial antibody positive adults with celiac disease suspicion, who were found to have a     only mild enteropathy (Marsh I-II) in the small-bowel mucosa. The investigators hypothesize     that these subject are indeed gluten-sensitive, as measured by clinical, serological and     histological indicators. If this would be the case, the current diagnostic criteria for     celiac disease might need re-evaluation.   "
213135|NCT00641082|"     A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The     purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine     and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.   "
212764|NCT00628836|"     The study looks at treatments for reversing chronic shoulder subluxation after a stroke. It     compares electrical stimulation with surface electrodes (stimulation through the skin) with     intra-muscular stimulation (from inside the muscle)using an implanted micro-stimulator     (BION). Subjects are put either in a surface stimulation or a BION® group. In the BION®     group, two BION®s are implanted in the shoulder, the medial deltoid and supraspinatus     muscles. Treatment consists of a baseline of 6 weeks, and 6 weeks of therapy, consisting of 2     sessions per day for 10 to 30 minutes each time. This is followed by 6 weeks without therapy.     If testing shows that after 6 weeks of therapy there is no reversal of subluxation, more     intense therapy is carried out for another 6 weeks. Treatment is similar in the surface     electrode group, but surface electrodes deliver the stimulation instead of BION®s. A total of     30 subjects is expected to complete the study.   "
212765|NCT00628849|"     Patients who sustain a broken lower jaw have traditionally been treated in one of three ways.     The first involves having their teeth and jaws being wired together for a period of 4 to 6     weeks in order to allow the broken jaw to heal. The second and third ways involve a surgical     procedure that requires exposing the broken bones and stabilizing them with metal plates and     screws that allow the patient to be able to function relatively normally during the healing     period. One surgical method uses small plates and screws while the alternate method uses     large plates and screws. Currently there are two schools of thought with respect to what     plates and screws should be used. One group supports the use of large rigid plates due to the     increased strength of the plate. The use of the larger and stronger plates is the principle     behind the AO technique, which was originally developed in the 1970's in Switzerland and is     now the more popular technique in the USA. The other group supports the use of smaller plates     and screws which must be placed in certain anatomical positions to allow the natural muscular     forces that exist on the jaw to stabilize the break and facilitate complete healing of the     broken bone. This technique was developed in France by Maxime Champy in the 1970's and is the     standard of care throughout Australasia and parts of Europe. This technique is simpler,     quicker and cheaper. The need for patients to maintain a diet with softer foods is considered     by many to be important for success if the less rigid and smaller plates are going to be     used. Many critics of the Champy technique feel that less compliant patient populations as     might be seen in a county hospital make the technique less readily suited to these     populations. This is contrary to published data from Europe, Australia and recently the USA.      The question of interest is whether the smaller plates and screws are equally as effective in     the treatment of broken lower jaws in an urban county hospital? If they are equally     effective, then is there any benefit in terms of fewer patient complications and decreased     health costs? If the smaller plates and screws are not adequate, then will a modification of     the original Champy technique improve their usefulness? Patients who present with a broken     lower jaw who require surgery will be treated in one of three ways. Some patients will be     treated with the larger plates and screws by an attending surgeon who routinely uses large     plates and screws for broken lower jaws. Another group of patients will be treated with the     smaller plates and screws using the Champy principles. A third group of patients will also be     treated with the smaller plates and screws but using a modification of the original Champy     technique that involves the use of additional small plates and screws for added stability.     Patients will then be followed over a three month period to evaluate for healing of the     broken jaw. The three techniques will be then be compared.      Larger plates/ screws and the smaller plates/ screws are both the standard of care. Regional     differences throughout the USA has continued to ensure differences of opinion with regard to     which technique is better although historically the larger plates/screws has been more     popular in the USA.   "
212766|NCT00628862|"     The purpose of this study is to show the efficacy and safety of formoterol for the     maintenance treatment of patients with COPD compared with placebo in patients in Japan and in     European countries during 12 weeks.   "
212767|NCT00628875|"     This study is a prospective, observational case series of a convenience sample of     mechanically ventilated pediatric patients in the Pediatric ICU, Progressive Care Unit and     Operating Room at the Children's Hospital of Philadelphia.      We propose to observe, measure and report the accuracy, precision and bias of defibrillator     electrode pads to detect breathing in stable but critically ill and mechanically ventilated     children. This study will provide preliminary data to inform the resuscitation research     community and assist development of evidence-based pediatric resuscitation guidelines in the     future.   "
212768|NCT00628888|"     This study will evaluate the effectiveness of an emotion-focused cognitive behavioral     treatment program for adolescents with anxiety or unipolar depressive disorders.   "
212769|NCT00628901|"     The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres     and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with     symptomatic uterine fibroids.   "
212849|NCT00635778|"     This study will look for the highest tolerated dose of MK-0646 when given as a every other     week infusion in patients with advanced solid tumors.   "
212770|NCT00628914|"     Preliminary studies suggest that the response to antidepressant medication can be accelerated     by targeting insomnia with adjunctive use of eszopiclone. It is not yet known what     mechanism(s) support this acceleration in response, though preliminary findings support the     hypothesis that early restoration of sleep may facilitate BDNF-based effects of     antidepressant medications. The optimal duration of co-treatment is also unknown. This study     will test specific hypotheses about brain mechanisms and evaluate the effects of continued     eszopiclone beyond the time window when response acceleration should be observed.   "
212771|NCT00628927|"     The purpose of this study is to determine whether performance on neurocognitive measures     predicts treatment outcomes in individuals with substance abuse disorders. A second purpose     is to compare the risk of damage, as well as actual damage, to DNA and other cell parts in     people with substance abuse disorders to that of people who do not have substance abuse     disorders.   "
212772|NCT00628940|"     The aim of the study is to define preferential sites of tumour recurrence by observing tracer     uptake in the tumour in sequential PET images with 18F-fluoromethylcholine (and perfusion MR,     see also below). Changes in the intensity of the tracer uptake in the tumour during and after     the course of radiotherapy will be correlated with the site of tumour recurrence as will be     assessed by conventional MRI. In due time, these results must enable clinicians to change     their therapeutic approach of high-grade glioma.   "
212773|NCT00628953|"     The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of     subjects with persistent asthma believed to have acid reflux as a contributory factor to     control of their asthma.   "
212774|NCT00628979|"     The purpose of this study is to understand some of the reasons why recently deployed veterans     decline psychosocial treatment options for panic disorder and to test a brief weekend     treatment for panic attacks.   "
212794|NCT00629252|"     This study aims to investigate whether the atypical antipsychotic and mixed 5-HT2/D2     antagonist sertindole modulates or improves both subcortical and cortical information     processing in schizophrenic patients who had not or insufficiently responded to previous     antipsychotic medication. This goal shall be accomplished by investigating the effect of     sertindole of both prepulse inhibition of the acoustic startle (PPI) and P50 suppression of     auditory evoked potentials in schizophrenic patients. These effects shall be compared to the     effect of risperidone and shall also be compared to untreated healthy controls.   "
212795|NCT00629265|"     The purpose of the investigation is to learn whether intense swallowing exercise or intense     swallowing exercise coupled with electrical stimulation (E-Stim) helps patients who had     head/neck cancer and currently have dysphagia swallow better.   "
212775|NCT00628992|"     Twenty per cent of the intensive care patients mechanically ventilated suffer from chronic     obstructive pulmonary disease (COPD). These patients stay longer in Intensive Care which is     more costly and they are more prone to nosocomial infection.In addition, they are longer     bedridden and they develop muscular weakness.Prolonged inactivity results in respiratory and     skeletal muscle weakness which curtails simple daily activity.The principal purpose of this     study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh     and/or cycloergometer training) to classic passive mobilization of the leg.The second purpose     is to analyse the effects of each type of rehabilitation on muscular fiber (structural and     functional analysis) by muscular biopsies.Two hundred forty COPD patients admitted in the     intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to     receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh     (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the     thigh and cycloergometer training(group 4, n=60).The rehabilitation program will last 4 weeks     with 5 sessions per week.In each group of patients, muscular biopsies will be done under     local anaesthesia at the beginning and end of the rehabilitation programme and when they are     discharged from the service.   "
212776|NCT00629005|"     People with stroke experience weakness and incoordination. Studies have shown that with     functional task practice, people can increase motor control and strength to a certain extent.     This study will investigate whether adding progressive resistance strength training to     functional task practice modeled after Constraint-Induced Movement Therapy results in greater     motor function gains than functional task practice alone   "
212777|NCT00629018|"     Several studies have documented that transplantation of bone marrow-derived cells (BMC)     following acute myocardial infarction is associated with a reduction in infarct scar size and     improvements in left ventricular function and perfusion. The available evidence in humans     suggests that BMC transplantation is associated with improvements in physiologic and anatomic     parameters in both acute myocardial infarction and chronic ischemic heart disease, above and     beyond the conventional therapy. In particular, intracoronary application of BMC is proved to     be safe and was associated with significant improvement in the left ventricular ejection     fraction (LVEF) in patients with chronic heart failure.      In contrast to ischemic heart failure, the data on effects of BMC transplantation in patients     with dilated cardiomyopathy are limited to pre-clinical studies. In a rat model of dilated     cardiomyopathy, intramyocardial delivery of pluripotent mesenchymal cells improved LVEF,     possibly through induction of myogenesis and angiogenesis, as well as by inhibition of     myocardial fibrosis, suggesting that the beneficial effects of stem cell transplantation in     dilated cardiomyopathy may primarily be related to their ability to supply large amounts of     angiogenic, antiapoptotic, and mitogenic factors. Similarly, transplantation of cocultured     mesenchymal stem cells and skeletal myoblasts was shown to improve LVEF in a murine model of     Chagas disease.      Study Aim:      To define the clinical effects of BMC transplantation in dilated cardiomyopathy in a pilot     clinical study investigating the effects of intracoronary CD34+ cell transplantation on     functional, structural, neurohormonal, and electrophysiologic parameters in patients with     end-stage dilated cardiomyopathy.   "
212778|NCT00629031|"     It is a randomized, double-blind, multi-center, two-arm study intended to assess the safety     and efficacy of three different doses/dose regimens of paromomycin administered     intramuscularly as follows: 11 mg/kg/day for 14 days and 11 mg/kg/day for 21 days for the     treatment of visceral leishmaniasis (VL) in India.   "
212779|NCT00629044|"     The aim of this study is to assess the implicitement of the cholesterol 24 S hydroxylase gene     and the 24 S hydroxycholesterol in glaucoma and in age related macular degeneration.   "
212780|NCT00629057|"     BNIT-PR-001 is an open-label, multi-center, Phase I dosing evaluation trial of MVA-BN®-PRO in     men with androgen-insensitive prostate cancer. Patients will have PSA recurrence after being     treated with androgen suppression therapy or complete androgen blockade.      The trial will consist of a treatment with up to 6 vaccinations with MVA-BN®-PRO at monthly     intervals, followed by a 1-year follow-up phase. A vaccination may be 1, 2, or 4 injections     of study vaccine.      The study is designed to examine safety as well as the effect of three different doses on     immune response.   "
212803|NCT00629369|"     Developing a method to maximize maternal expulsive effort should be of great value in     reducing the number of cesarean section or instrumental deliveries. Various investigations     have shown that use of an occlusal support device (OSD) increases the isometric strength of     different muscle groups. The aim of our study was to investigate the role of an OSD in second     stage pushing.   "
212781|NCT00629070|"     Our primary aim is to determine whether and how muscle architecture of the quadriceps muscles     in cerebral palsy (CP) adapts to two separate training programs: traditional strength     training (ST) vs. velocity-enhanced training (VT). For the ST group, we hypothesize that     muscle size will increase in conjunction with strength. For the VT group, in addition to the     above, we hypothesize that fiber length will increase with measures of muscle power. We also     hypothesize that walking velocity will improve in both groups but that knee motion and step     length will improve only with VT.   "
212782|NCT00629083|"     The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid®     in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency     (ISD) in adult women who have SUI or stress predominant mixed incontinence   "
212783|NCT00629096|"     The main aim of the study is to determine whether intracoronary infusion of autologous bone     marrow mononuclear cells can improve the ventricular function of patients with idiopathic     dilated cardiomyopathy.Secondary end-points will be:        1. To evaluate possible changes in patient functional capacity and        2. to identify the biological characteristics of the bone marrow graft that might influence          on functional recovery.   "
212808|NCT00629447|"     To determine the safety of prophylaxis with Tinzaparin low molecular weight heparin in     primary brain tumor patients. 2. To determine the incidence of deep venous thrombosis or     pulmonary embolism in brain tumor patients who will be receiving Tinzaparin as primary     prophylaxis. 3. To determine the overall survival of patients with malignant glioma who     receive Tinzaparin. 4. To determine the bone density before and after prophylactic     Tinzaparin.   "
213163|NCT00641446|"     A study to determine whether treatment with Pulmicort in children has any effect on the     varicella vaccine   "
212784|NCT00629122|"     Tacrolimus (Prograf) belongs to a class of medications known as the calcineurin inhibitors.     It is a maintenance drug that is used to prevent rejection in kidney, liver, and heart     transplant recipients. Calcineurin inhibitors display high pharmacokinetic (the body's     effects on a drug) variability and necessitate use of blood tests to ensure that adequate     drug levels are present to maintain effectiveness and safety. The amount of oral tacrolimus     that is absorbed varies in all patient populations studied. Tacrolimus is metabolized or     broken down for elimination by the liver and small intestine via cytochrome P450 (CYP)3A4,     CYP 3A5, and p-glycoprotein enzyme systems. Enzyme activity is affected by several single     nucleotide polymorphisms (SNPs) in an individuals genetic make-up and differences in     expression may contribute to variations in tacrolimus pharmacokinetics. There are number of     drug-drug interactions where concomitantly administered medications can increase or decrease     this break down of tacrolimus. Early after transplant or at times when tacrolimus cannot be     taken by mouth, alternative routes of administration are sought. Although an intravenous     (through the vein) product is available, it can be toxic to the kidneys and has been     associated with allergic reactions. Studies in lung transplant recipients have utilized     sublingual (under the tongue) tacrolimus administration with successful outcomes. Drug     delivery via the oral mucosa is an alternative method of systemic drug administration which     offers an alternative when oral administration is impractical (gastrointestinal dysmotility,     reduced drug absorption, intestinal failure, difficulty in swallowing, or in those with     nausea or vomiting). Administration of tacrolimus by the sublingual route allows for direct     entry into the systemic circulation and bypasses problems associated with drug absorption and     breakdown that take place in the small intestine. In order to learn more about the possible     role of sublingual tacrolimus among transplant recipients we will administer tacrolimus     sublingually. In addition, we will evaluate differences in expression and bioactivity of SNP     polymorphisms and their effects in tacrolimus pharmacokinetics. Patients awaiting kidney     transplantation who are listed on the kidney transplant waiting list or those with upcoming     living donor transplants at our center will be administered five doses of sublingual     tacrolimus followed by five doses of oral tacrolimus. We will evaluate and then compare the     pharmacokinetic characteristics of sublingual and oral tacrolimus administration among the     study participants. The purpose of this study is to assess the pharmacokinetic and     pharmacodynamic parameters of tacrolimus after sublingual and oral administration. A     secondary objective is to assess the drug-drug interaction between concomitant therapy with     clotrimazole.   "
212785|NCT00629135|"     The study is contemplating the antibiotic therapy of intraabdominal abscesses. These     abscesses are a serious problem in surgical practice. Associated pathophysiologic effects as     for example peritonitis may become life threatening or may lead to extended periods of     morbidity with prolonged hospitalization.      The objective of the sudy is to evaluate whether the combination of Moxifloxacin and     Metronidazole is equivalent to Piperacillin / Tazobactam with regard to clinical outcome and     eradication of aerobe and anaerobe pathogens in patients with intra-abdominal abscesses.   "
212786|NCT00629148|"     The primary objective of this study is to evaluate the efficacy and tolerability of     sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.   "
212787|NCT00629161|"     This study was designed to evaluate the symptomatic effects or potential disease progression     slowing down effect of a kind of Traditional Chinese Medicinal Mixture in Parkinson's disease     (PD) patients. The treatment phase includes 12 months period of Traditional Chinese Medicinal     Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.   "
212788|NCT00629174|"     The trial will evaluate the effects of frequent exercise and increased mental activity on the     age-related impairment of cognitive function in elderly women. Furthermore, we will assess     the effects of exercise and mental activity on the mood, physical performance and mental     status of participants. We will also search for genetic factors which may be responsible of     the observed outcomes.   "
212789|NCT00629187|"     The goal of this study is to find the maximum dose of a drug, temozolomide, that can safely     be given to subjects with brain tumors. Past studies showed that the maximum dose of     temozolomide was limited by low blood counts. The investigators will use blood stem cells     collected from bone marrow to help subjects recover their blood counts, a procedure called     autologous stem cell transplant or stem cell rescue. This way, the investigators expect to be     able to safely deliver very high doses of temozolomide. This study is only available at Tufts     Medical Center.   "
212790|NCT00629200|"     Primary Objective:      -To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in     combination with IFN alpha2b in patients with advanced malignancies.      Secondary Objectives:        -  To correlate the AUC of SSG with clinical toxicity and efficacy.        -  To quantify the effect of SSG on IFN alpha2b induced gene modulation and signal          transduction pathways.        -  To characterize the effects of SSG on PTPases SHP-1 and SHP-2.        -  To assess the safety, efficacy, and PK of SSG in combination with IFN alpha2b.   "
212791|NCT00629213|"     The aim of the study was to analyse the independent and joint effects of the components of     the metabolic syndrome (MetS) on the incidence of diabetes in people with impaired glucose     tolerance (IGT) and to assess the effect of acarbose by MetS status.      Double-blind placebo controlled trial, 1,368 patients, follow-up time 3.3 years. MetS by ATP     III definition with fasting plasma glucose of ≥ 6.1 mmol/l as limit for impaired fasting     glucose (IFG).   "
212819|NCT00635024|"     RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune     system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such     as melphalan, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Anti-thymocyte globulin may also make cancer     cells more sensitive to melphalan. Giving anti-thymocyte globulin together with melphalan may     kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together     with melphalan works in treating patients with relapsed multiple myeloma.   "
213844|NCT00652483|"     This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared     with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension   "
212792|NCT00629226|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses     high energy x- rays to kill tumor cells. Bortezomib and cetuximab may make tumor cells more     sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving bortezomib together with cetuximab, radiation therapy, and     cisplatin may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     given together with cetuximab and radiation therapy with or without cisplatin in treating     patients with stage IV head and neck cancer.   "
212793|NCT00629239|"     The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable,     safe and effective in treating COPD and, if so, how it compares with placebo.   "
212796|NCT00629278|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as trastuzumab, can block tumor growth in different ways. Some block the ability of     tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. It is not yet known which regimen of combination     chemotherapy given together with trastuzumab is most effective in treating breast cancer.      PURPOSE: This randomized phase III trial is comparing two different regimens of combination     chemotherapy given together with trastuzumab to see how well they work in treating women with     HER2-positive stage I, stage II, or stage III breast cancer.   "
212797|NCT00629291|"     Sickle cell anemia and Sickle cell β thalassemia patients require multiple transfusions in     order to avoid chronic anemia sequel. This regimen entails intrinsic deleterious effects, the     majority of which are related to iron deposition in the reticuloendothelial system. Thus,     iron is deposited in hepatic, myocardial and endocrine glands tissues. Tools available for     iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are     non specific.      The purpose of this work is to compare iron overload in the liver, heart and pancreas in     Sickle cell anemia and Sickle cell β thalassemia patients using T2* MRI sequences.   "
212798|NCT00629304|"     TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of     the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or     telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1     diabetic patients, despite intensive insulin therapy (multiple daily injections with     basal-bolus insulin or insulin pump), as compared with conventional care.      Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months   "
212799|NCT00629317|"     The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite     in facial photodamage in a randomized double blind trial.   "
212800|NCT00629330|"     The aims of this project are to adapt and extend the use of academic detailing to the     dissemination of prostate cancer (CaP) screening findings to primary care physicians     practicing in African American communities. The objectives of this study are:      1. To test the hypothesis that a community physician-based educational intervention     (multi-component academic detailing, including an interactive, digitized, web-based program     for informed decision-making about prostate cancer, and patient education materials designed     for low literacy patients) will increase physician knowledge, positive attitudes/beliefs     toward screening and screening options, and prostate cancer screening (using the digital     rectal exam, and the serum prostate specific antigen test) at baseline, 6-, and 12-months     post- randomization, compared to the rate observed in a service- as-usual control.      1A. To demonstrate the feasibility of disseminating the American Cancer Society guidelines     for prostate cancer screening among primary care practitioners using multi-component academic     detailing.      2. To develop models predicting which physician offices are most and least likely to adopt     the intervention, and to generate hypotheses about tailoring the dissemination of PC     screening guidelines to different physician subgroups.      The long term goal of this project is to increase prostate cancer screening among African     American communities, thus decreasing cancer-related morbidity and mortality.   "
212801|NCT00629343|"     The purpose of this study is to determine safety and toxicity for the combination of     Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant     Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial.     Patients will be evaluated with complete history and physical as well as laboratory studies     (complete blood count, metabolic panel, liver function tests), biopsy, and imaging of all     sites of measurable disease. This study will be conducted over the course of 3 years.   "
212802|NCT00629356|"     Originally test host's to understand the tracking healthily and immune change of the dengue     fever in Taiwan. Blood drawing 20 c.c for liver examination, kidney and other biochemical     function, analyze host immunity adjusts and controls the gene, and the reciprocation that may     be produced with the virus hepatitis, besides collected 10 c.c urine at the same time. Urine     check is in order to compare acute infect and infected over three month person, the change of     chemical composition.      This plan expect to collect 150 healthy, 150 dengue fever infected and 150 dengue fever bleed     hot or dengue fever shock disease group's patient, goal to understand health state and     immunity of follow-up adjust and control the difference of the gene and the reciprocation may     produce to virus hepatitis of light disease and serious disease.   "
212804|NCT00629382|"     This clinical study designed as a prospective, open labelled, multi-centre, RCT will be     carried out to evaluate if direct hemoperfusion with polymyxin B immobilized fiber column     (PMX) is superior to conventional medical therapy for sepsis, for patients with sepsis     arising from abdominal cavity infection, accompanied by the failure of one or more organs.     120 patients (60 treatment/60 control) will be considered in this study. Those patients     fulfilling inclusion criteria and not having exclusion criteria will be randomly allocated to     one of two study groups. One group will be treated with PMX (PMX group) and the other will     receive a standard therapy for sepsis (control group). All patients will receive full     intensive care management, including fluid resuscitation, vasopressors, antimicrobial     chemotherapy, ventilatory support, and renal replacement therapy, if required. Each patient     will be followed up for 28 days after study entry.   "
212805|NCT00629395|"     Specific Aim 1: To assess the feasibility and acceptability of a home-based, computerized     attention training program with survivors of central nervous system (CNS) impacting pediatric     cancer (e.g. acute lymphocyte leukemia [ALL], brain tumors).      Specific Aim 2: To estimate the effect size of this attention training program with survivors     of childhood cancer to determine whether a larger-scale clinical trial is warranted.   "
212806|NCT00629421|"     Although serum alpha-fetoprotein level and abdominal sonography are the main methods to     screening hepatocellular carcinoma (HCC) in cirrhotic patients, the adequate time and methods     used are not completely well-defined. This study aims to assess the better timing and methods     for prospectively screening HCC in patients with cirrhosis   "
212807|NCT00629434|"     This study compares group diabetes education in-person versus via telemedicine   "
212852|NCT00635817|"     The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are     effective in treating children with Central Precocious Puberty (CPP).   "
212809|NCT00629460|"     Because the management of children with solid tumors hinges on the extent of disease, it is     crucial to identify metastatic sites. Helical chest computed tomography (CT) is the standard     method of excluding pulmonary metastases. However, CT lacks molecular information regarding     nodule histology and often biopsy is required to exclude malignancy. Biopsy procedures carry     known risks including those associated with anesthesia and sedation, infection, pneumothorax,     hemorrhage, pain and other post-procedure and post-operative complications and may also add     unnecessary cost to the management of the patient. We found that the ability of three     experienced pediatric radiologists to correctly predict nodule histology based on CT imaging     features was limited (57% to 67% rate of correct classification). Also, there was only slight     to moderate agreement in nodule classification between these reviewers.      Furthermore, of 50 children who have undergone pulmonary nodule biopsy at St. Jude in the     last five years, 44% (22/50) had only benign nodules.      Adult studies have shown that a nuclear medicine scan called fluoro-deoxyglucose (FDG)     positron emission tomography (PET) and the fusion modality PET-CT are superior to diagnostic     CT in distinguishing benign from malignant pulmonary nodules because FDG PET gives     information about the metabolic activity of the nodule. Nodules that are malignant have more     metabolic activity, hence more FDG uptake/intensity, than those that are benign. There has     been little work done in children to determine the value of PET or PET-CT in the evaluation     of pulmonary nodules.   "
212810|NCT00629473|"     This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics     of escalating doses of the proteasome inhibitor NPI-0052 in patients with advanced     malignancies including solid tumors, lymphomas, leukemias and multiple myeloma. By inhibiting     proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction,     which blocks growth and survival in cancer cells.   "
212811|NCT00629486|"     By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine     gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.   "
212812|NCT00629499|"     This is a non-randomized, Phase II study. Efficacy is not a primary endpoint in this study;     however, progression-free survival will be followed and determined for the patients in this     study. Approximately 50 patients are planned to be enrolled in this study.   "
212813|NCT00629512|"     Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This     study looks at the prevention of these gastric ulcers with one of the three following     treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once     daily; versus placebo; in patients at risk.   "
212814|NCT00634959|"     To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc     (UK-427,857) in patients with human immunodeficiency virus (HIV)   "
212815|NCT00634972|"     The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye     drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or     decrease its severity.In this study ACULAR will be compared to a placebo (artificial tear).      The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to     severe ROP (grade II and above)by 50%.   "
212816|NCT00634985|"     To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who     had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)   "
212817|NCT00634998|"     The purpose of this pilot study is to determine whether vitamin C supplementation is     beneficial in treating and/or preventing diabetic peripheral neuropathy in people with type 2     diabetes.   "
212818|NCT00635011|"     The purpose of this study is to investigate the relationship between the potential predictive     psychological variables and success after bariatric surgery. The investigators will also     investigate the purpose of a pre- and postoperative psychological intervention.   "
212842|NCT00635687|"     Transient elastography is a new non-invasive rapid and reproducible method, allowing     evaluating liver fibrosis by measurement of liver stiffness.      The aim of our study is to evaluate if the liver stiffness can predict the recurrence of     upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture.   "
212843|NCT00635700|"     This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for     patients with the psychosis prodrome.   "
212820|NCT00635037|"     CONTEXT AND OBJECTIVE: Myofascial syndrome is the most frequent condition of chronic pain.     The objective of the present study was to compare the analgesic action of acupuncture and     trigger point injection combined with cyclobenzaprine and dipyrone.      DESIGN AND SETTING: A randomized study was performed at the Pain Clinic. METHODS: Thirty     patients were divided into two groups: G1 received trigger point injection of 0.25%     bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8     h. G2 was submitted to classical and trigger point acupuncture twice a week. The patients     were asked to continue physical exercise. The following parameters were evaluated: pain     intensity rated on a numerical and verbal scale, quality of life before and four weeks after     treatment, and quality of analgesia.   "
212821|NCT00635050|"     This study will evaluate the rate of pathological complete response (pCR) to the sequential     therapy of Doxil, paclitaxel, and cyclophosphamide with concurrent Avastin for patients with     locally advanced invasive (T2,T3, Nany, M0) breast carcinoma. Also, the study will evaluate     the clinical and subclinical cardiotoxic effect(s) of this regimen, assess how feasible and     safe the study is. Survival without any progression of disease will also be calculated.      A regimen of chemotherapy will be given to replicate the high rate of pCR seen with     conventional chemotherapy in patients with locally advanced breast cancer. Doxil will     substitute the normally given doxorubicin. It is expected that the low effect or minimal     effect of Doxil on cardiac function will minimize any additional risk of cardiotoxicity from     Avastin. It is expected that clinical and subclinical rates of cardiotoxicity will be very     low at the total doses to be given in this clinical trial.   "
212822|NCT00635063|"     Purpose:      The purpose of this study is to compare the efficacy and safety of AD 923 to the most widely     used current treatment (MSIR) in the management of target BTP in subjects with malignancies     who are taking a stable dose of background opioids. The efficacy evaluation criteria have     been designed to determine whether AD 923 provides superior analgesia compared with MSIR as     measured by the primary endpoint.   "
212823|NCT00635076|"     The purpose of this study is to evaluate the long-term (6-month) efficacy, safety, and     tolerability of alprazolam XR in adolescents with panic disorder.   "
212824|NCT00635089|"     This study is an open-label study where all subjects will receive active drug, reslizumab.     Subjects are able to enter this trial only through completion of study Res-05-0002     (NCT00538434).      The goal of the study is to show longer term safety and efficacy in pediatric subjects who     have eosinophilic esophagitis.   "
212825|NCT00635102|"     Question #1: Will glycine ameliorate cognitive deficits? Hypothesis #1: Based on positive     findings conducted with glycine and milacemide, a glycine prodrug, in schizophrenia and     dementia, we expect that glycine will ameliorate cognitive deficits.      Question #2: Will alcoholic patients show enhanced endocrinal effects to glycine? Hypothesis     #2: Based on the dose-related effects of glycine in healthy subjects, we expect that glycine     will increase the endocrinal response to glycine in alcoholic patients with, supposedly,     dysregulated NMDA receptor function.      Question #3: Will D-cycloserine have ethanol-like effects? Hypothesis #3: If inhibition of     NMDA receptor function is fundamental to the subjective effects of ethanol, then the NMDA     antagonist properties of D-cycloserine should be recognized as ethanol-like (relative to     placebo) in recently detoxified alcoholics and healthy subjects.      Question #4: Will D-cycloserine reverse cognitive benefits of glycine? Hypothesis 4: Based on     the dose related NMDA antagonist activity of D-cycloserine, we expect that D-cycloserine will     compete with the agonist activity of glycine and therefore it will reverse the cognitive     benefits of glycine.      Question #5: Will D-cycloserine inhibit endocrinal effects of glycine? Hypothesis #5: If the     agonist activity of glycine is necessary to determine endocrine response, then the     dose-related NMDA antagonist properties of D-cycloserine should block these effects.   "
212826|NCT00635115|"     The VEPRO trial is a cross-over randomised controlled trial comparing 2 corrective lenses for     patients with presbyopia. The aim of the study is to compare the effectiveness of two     corrective lenses: an old generation (Varilux Comfort Orma Crizal) and a new generation     (Varilux Panamic Orma Crizal) of corrective lenses prescribed in presbyopia.   "
212827|NCT00635128|"     Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be     evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will     be evaluated in terms of immunogenicity, safety and reactogenicity.   "
212828|NCT00635141|"     This study is examining the effect of hypertonic saline compared to placebo on the Lung     Clearance Index in Cystic Fibrosis patients.   "
212829|NCT00635154|"     RATIONALE: Some cancers need growth factors which are made by the body's white blood cells to     keep growing.Anakinra may interfere with the growth factor and stop multiple myeloma from     growing. Dexamethasone may stop cancer cells from growing. Giving anakinra together with     dexamethasone may be an effective treatment for multiple myeloma.      PURPOSE: This phase II trial is studying how well anakinra works when given with or without     dexamethasone in treating patients with smoldering myeloma or indolent multiple myeloma.   "
212830|NCT00635167|"     Solid tumors, including prostate cancer, commonly exhibit tumor-associated neovascularity     (growth of new blood vessels to feed the tumor) with increased microvessel density. Systemic,     hormonal, and radiotherapy treatments typically decrease or suppress tumor - associated     vascularity through several mechanisms, including apoptosis (process of cell death) and     anti-angiogenic pathways (ways to destroy new blood vessel growth). Previously at the     investigators' center, they have demonstrated that increased prostatic vascularity (blood     vessels defined to prostate) detected ultrasonographically correlated with disease free     survival after radical prostatectomy (surgical removal of entire prostate), and may be     indicative of higher grade, higher stage disease. The significance of prostate neovascularity     in response to treatment with external beam radiotherapy (EBRT) (standard of care) has not     been well studied. The investigators hypothesize that prostate cancer that recurs after     radiotherapy may exhibit measurable patterns of tumor-associated vascularity, which may     represent a minimally invasive marker of cancer stage, grade and response to treatment. The     investigators propose a pilot study to assess the feasibility of serial enhanced transrectal     ultrasonography (TRUS) examinations during and after radiotherapy for prostate cancer.   "
212831|NCT00635180|"     The purpose of this study is to investigate changes in intraocular pressure measured     continuously during isometric exercise.   "
212832|NCT00635193|"     This is an open-label study of liposomal doxorubicin with or without volociximab for the     treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer     relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic     integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a     surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in     terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft     models. In clinical studies, volociximab has been evaluated in several solid tumor types,     including pancreatic, renal, and melanoma, with many subjects who entered the studies with     progressive disease remaining progression-free for several months. In all studies in solid     tumors, volociximab has shown a favorable safety profile when administered at 10 mg/kg q2wks     and more recently at 15 mg/kg qwk. A study of volociximab in combination with liposomal     doxorubicin in subjects with ovarian cancer or primary peritoneal cancer who have relapsed     after prior platin/taxane therapies is warranted to further evaluate the drug's efficacy and     safety. The investigators have thus far activated stage 2 of this study at 11/25 sites.     Worldwide, the study aims to enroll 150 subjects.   "
212853|NCT00635830|"     To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is     generally safe and well tolerated in the Chinese population.   "
212854|NCT00635843|"     The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™     Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease     at one level from L4-S1, with overall success being the primary endpoint of the clinical     trial. The primary objective is to show non-inferiority of the investigational device to the     control treatment. If non-inferiority is established, superiority will be examined.   "
212855|NCT00635856|"     A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and     who have rising PSA levels   "
212931|NCT00636870|"     To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and     fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of     desloratadine compared to fexofenadine following single and multiple oral doses administered     to desloratadine slow metabolizers.   "
212833|NCT00635206|"     The primary objective outcome is the proportion of participants compliant (at least four     hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group     after 90 days of treatment during the investigation. Proportion will be calculated using the     cumulative number of hours on therapy divided by the total number of days of the     investigation for each participant. The mean and standard deviation of these mean therapy     hours will then be calculated for each arm of the investigation. Participants with compliance     of at least four hours will be classified as compliant and those with less than four hours     will be classified as non-compliant. The null hypothesis will be rejected if the mean of     the primary objective outcome for all participants in the BiPAP® Auto with Bi-Flex® therapy     arm is significantly greater than that for all participants in the CPAP therapy arm.      Secondary Measures      The secondary measures used to evaluate potentially improved adherence to BiPAP® Auto with     Bi-Flex® therapy compared to CPAP therapy will include:        -  Hours of use per night, for all nights        -  Hours of use per night, for nights with therapy use        -  Device derived AHI        -  Heart Rate Variability        -  Functional Outcomes of Sleep Questionnaire (FOSQ),        -  10 cm Visual Analog Scale (VAS) for mask comfort and satisfaction with therapy,        -  Epworth Sleepiness Scale (ESS) questionnaire        -  Psychomotor Vigilance Task        -  Attitudes toward use        -  Actigraphy (sleep continuity) and sleep diary        -  Fatigue Severity Scale        -  Daytime Functioning Scale   "
212834|NCT00635219|"     The purpose of the study is to evaluate the efficacy and the tolerability of three fixed     doses of Vortioxetine in order to establish the appropriate clinical effective dose range in     the treatment of Major Depressive Disorder (MDD).   "
212835|NCT00635232|"     The purpose of this study is to learn which doses of PS433540 should be given to patients     with high blood pressure to lower their blood pressure. This study will also examine how safe     PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will     be evaluated so that about 375 patients will be entered into the treatment phase of the study     and be given PS433540.   "
212836|NCT00635245|"     RATIONALE: Monoclonal antibodies, such as CP-751871, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them.      PURPOSE: This phase I trial is studying the side effects and best way to give CP-751871 in     treating patients with early-stage breast cancer that can be removed by surgery.   "
212837|NCT00635258|"     This prospective and randomized study was performed to evaluate whether the replacement of     GnRH agonist by a GnRH antagonist in oocyte donation recipients during endometrial     preparation has any impact on pregnancy and implantation rates.   "
212838|NCT00635271|"     This study will look for a relationship between asthma and factors released from the lungs in     exhaled breath. If a relationship can be established, the identified factors may be used as     biomarkers to predict episodes of increased asthma symptoms so that medications can be given     to prevent the onset of an asthma attack.      Healthy volunteers and people who have had asthma for at least 1 year may be eligible for     this study. Candidates must be between 18 and 75 years of age.      Participants undergo blood tests and breathing tests. For the latter, participants breathe     into a machine before and after inhaling an asthma medication called albuterol. The machine     measures the volume of air the subject can breathe out. Participants also provide a sample of     exhaled breath by breathing normally for up to 30 minutes while wearing a mask devised for     the procedure. Pulse rate, oxygen saturation and wheezing are monitored during the breath     collection....   "
212839|NCT00635284|"     To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009     given weekly; to characterize the toxicities of ABI-009; and to determine the pharmacokinetic     parameters for ABI-009 when given on a weekly schedule.   "
212840|NCT00635661|"     The Stroke Rehabilitation Assessment of Movement (STREAM) is a relatively new measurement     tool, which measures specific movement deficits (impairments) caused by a stroke. The STREAM     is used to evaluate recovery of voluntary movement and basic mobility following the onset of     a stroke. Several important clinical measurement properties of the STREAM remain to be     explored, including its ability to measure impairments and clinical change in acute     rehabilitation patients in the USA. We hypothesize that the STREAM will be able to detect and     quantify a statistically significant change in the motor abilities of stroke patients from     admission to discharge. An additional aim of the study is to compare the STREAM with two     accepted and widely used clinical measures of function and disability, the Stroke Impact     Scale (SIS)and the Functional Independence Measure (FIM). By linking movement deficits that     are commonly assessed by physical therapists with measures of function and disability, the     impact of the movement deficits can be understood.   "
212841|NCT00635674|"     The increased risk of atherosclerotic morbidity and mortality in patients with obstructive     sleep apnea (OSA) has been linked to arterial hypertension, insulin resistance, systemic     inflammation, and oxidative stress in previous studies.      We aimed to determine the effects of 8-weeks therapy with continuous positive airway pressure     (CPAP) on glucose and lipid profile, systemic inflammation, oxidative stress, and the global     cardiovascular disease (CVD) risk in patients with severe OSA and metabolic syndrome.   "
212850|NCT00635791|"     This phase I trial studies the side effects and best dose of giving vorinostat and sorafenib     tosylate together in treating patients with kidney or non-small cell lung cancer. Vorinostat     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Sorafenib tosylate may stop the growth of solid tumors by blocking blood flow to the tumor.     Giving vorinostat together with sorafenib tosylate may kill more tumor cells.   "
212851|NCT00635804|"     This study will examine the safety, tolerability and plasma pharmacokinetics of multiple     doses of MK-3281 in healthy male participants in Part I, and in Hepatitis C Virus     (HCV)-infected male participants in Part II. The clinical efficacy of MK-3281, as measured by     viral load reduction, will also be assessed in Part II. The primary hypothesis is that twice     daily administration of MK-3281 for 10 days in healthy adult male participants and for 7 days     in HCV-infected male participants is sufficiently safe and well tolerated, based on     assessment of clinical and laboratory adverse experiences, to permit continued clinical     investigation.      The results of this study will guide dose selection for future studies in both healthy     participants and HCV-infected participants.   "
212856|NCT00635869|"     The primary aim of this pilot study is to evaluate the effects of two variations of the ARCC     Intervention Program on nursing processes and outcomes (job satisfaction, group cohesion, EBP     knowledge, EBP implementation, EBP beliefs), patient/family outcomes (e.g. pt/family     satisfaction with care), and institutional processes and outcomes (e.g. nurse-physician     collaboration, cost, RN turnover, incidence frequency relevant to the topic). Secondary aims     are to test the feasibility of study methods and reliability and validity of questionnaires.      This study is designed as a three-group randomized clinical trial with repeated measures.     Three inpatient units (medicine, surgery, surgical intensive care) will be randomly assigned     to one of three interventions: ARCC enhanced (didactic content presentations, use of an EBP     tool kit which will stay on the unit, environmental EBP prompts, availability of an EBP coach     on the unit); ARCC standard (all of the above, but without the coach); non-EBP intervention     (didactic content and environmental prompts, but not related to EBP; placebo). The     interventions will be implemented over an estimated 14 weeks, including a 4-week training     period, and an estimated 10 weeks to implement an EBP initiative that the nurses on the two     ARCC intervention units will develop.      Baseline information and questionnaires will be collected from nurses at the start of the     study, and again at completion of the intervention phase. Outcome data will be collected from     nurses approximately 10 weeks after implementation of the ARCC interventions are completed     (i.e., 22 weeks after the study is commenced). Nurse-physician collaboration data will be     collected from physicians working with study unit nurses as well as from the nurses. Patient     satisfaction data will not be separately collected in this study, but will include use of     unit-level Press-Ganey scores immediately prior to and over the study time period. Unit level     and institutional RN turnover will be tracked monthly during the entire study period and will     be compared across units at the same time as well as compared within each study over time     (i.e., unit retention during those same months in the previous year). Costs of each EBP     intervention will be tracked during the study and compared descriptively. Survey data will be     analyzed using analysis of variance statistics. Questionnaires will be tested for reliability     and construct validity. Because this is a pilot study, statistically significant differences     are not expected, however, effect sizes will be calculated   "
212857|NCT00635882|"     This is a 2-week double-blind, placebo-controlled, parallel group study comparing the     anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol     fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate     (MF) dry powder inhaler (DPI) and MDI formulations in adults and adolescents with persistent     allergic asthma.   "
212858|NCT00635895|"     The present study was designed to analyze and compare the effects of Manual Lymph Drainage     Therapy and Connective Tissue Massage in females with Fibromyalgia (FM).   "
212859|NCT00635921|"     Objective: The aim of this double-blind, placebo-controlled study was to evaluate the     efficacy and tolerability of ziprasidone in the treatment of adult patients with Borderline     Personality Disorder (BPD).      Method: Sixty BPD patients were included in a 12-week, single-center, double-blind,     placebo-controlled study. The subjects were randomly assigned to ziprasidone or placebo in a     1:1 ratio following a two-week baseline period. The Clinical Global Impression scale for use     in BPD patients (CGI-BPD) was the primary outcome measure, and other scales and self-reports     related to affect, behavior, psychosis, general psychopathology domains and clinical safety     were included.   "
212860|NCT00635934|"     The purpose of this clinical trial is to collect safety and effectiveness data concerning the     A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with     lumbar degenerative disc disease at one level from L4-S1. Overall success will be the primary     clinical endpoint.   "
212861|NCT00635947|"     The purpose of this study is to determine the effect of maternal hydration with oral isotonic     solution and water on amniotic fluid (AF) index in women with normohydramnios.   "
212862|NCT00635960|"     Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine,     creatine, Vit. E, Pentoxifylline, etc. Although most of the trials showed a positive trend,     none of them reached a statistically significant result. The only exception is the Riluzole     trial, that demonstrated a small but significant reduction in mortality between treated and     untreated patients. Aim of our study is to determine if the add-on of GH to treatment with     Riluzole is able to reduce neuronal loss in the motor cortex of ALS patients.   "
212863|NCT00635973|"     A trial to assess patients who have been treated with Iressa in a previous clinical trial and     may benefit from continued treatment with Iressa.   "
212874|NCT00636116|"     The purpose of this study is to establish if F(ab)2 antivenom (Anavip) is safe for crotalinae     envenomation. Confirm its effectiveness in preventing the occurrence of delayed     coagulopathies and compare the safety and efficacy with Fab antivenom (CroFab) in patients     with Crotalinae envenomation.   "
212875|NCT00636129|"     We are looking at the effects of Stress Management and Relaxation Response training on stress     hormones (like adrenalin and cortisol), immune function and physiology (heart rate, breathing     rate, muscle tension).   "
213242|NCT00642499|"     The primary purpose of this study is to determine if dronabinol is effective in preventing or     treating nausea caused by HAART (highly active anti-retroviral therapy) in HIV and AIDS     patients   "
212864|NCT00635986|"     CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after     epidural injection. The objective of this investigation was to compare the analgesic effect     of epidural and intravenous Fentanyl for lower limb orthopedic surgeries.      DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo.      METHODS: 29 patients were divided into two groups. During the postoperative period, in the     presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in     saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n =     15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl     intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL     epidural 0.25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity     was evaluated by numerical scale and plasma concentrations of Fentanyl were measured     simultaneously.   "
212865|NCT00635999|"     This study will evaluate the effectiveness of three adaptive coping treatments in lessening     anxiety in adults with generalized anxiety disorder.   "
212866|NCT00636012|"     Aim of the study is to investigate specific effects of acupuncture points.   "
212867|NCT00636025|"     The purpose of this study is to compare the anatomy of subcutaneous structures in areas with     and without cellulite on the buttocks of same subjects with a non invasive technique,     Magnetic Resonance Imaging.   "
212882|NCT00636220|"     This protocol is intended to test the feasibility of using the HIV 1/2 STAT-PAK and the DPP     HIV 1/2 test (with and without the DPP Handheld Reader) to detect HIV antibodies in oral     fluids.   "
212883|NCT00636233|"     The goal of this research study is to discover the genetic and environmental factors that     contribute to the cause of neural tube defects such as spina bifida and anencephaly.     Ultimately, this type of research may result in improved diagnosis, improved treatment and     possibly prevention.   "
214127|NCT00655161|"     This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with     curative intent who are disease free at their first post-treatment restaging assessment.   "
212868|NCT00636038|"     The study hypothesis is that high ß-C yellow maize can provide vitamin A efficiently.      - list item one ß-C in yellow maize      The study will use stable isotope labeled high ß-C yellow maize and vitamin A in a     well-nourished population by utilizing stable isotope dilution techniques. In this project,     deuterium labeled vitamin A that is derived from the labeled ß-C yellow maize will be traced     after being eaten by a human subject. Eight men (> 40 years and < 70 y) who are healthy,     non-smoking,body weight within 20% of standard weight for height (Metropolitan) and not     having taken vitamin A or ß-C supplements within the last month will be recruited as     volunteers. This study will last for 50 days during which at day 1, cooked labeled yellow     maize paste (porridge) equal to a total of ~ 2 bowls cooked yellow maize (from 100 - 200 g     dry weight) containing ~ 1 mg ß-C will be taken by each volunteer. On day 8, a labeled     vitamin A (1 mg of 13C retinyl acetate) in oil dose will be used in evaluation of liver     storage of vitamin A. Forty six blood samples (460 cc) will be taken during the study which     will be analyzed for serum carotenoids and retinoids using HPLC and mass spectrometry     techniques.      The serum concentration and isotope ratio of ß-C and retinol will be determined. Serum     enrichment curve following each oral dose will be studied. The area under the curve (AUC) of     retinol-d4 and labeled retinol from the reference dose in serum samples will be determined     and compared. The equivalence of a high ß-C corn meal to vitamin A will be calculated based     on the isotope reference method to determine the efficiency of corn ß-C to provide vitamin A.   "
212869|NCT00636051|"     The purpose of this study is to evaluate the effectiveness of the introduction of an EBP text     for Nursing Research Council (NRC) members to use with RN staff to increase staff belief in,     knowledge of and implementation of EBP in providing patient care. The theory that will drive     this study is Disciplined Clinical Inquiry (DCI).      The current study will use a quasi-experimental design plus DCI to engage unit RN staff in     deciding how they might learn about EBP in a feasible, useful way. After collection of     baseline data, the NRC member will introduce the text + solicit staff input into a plan for     using the text to increase understanding of EBP and use of evidence to make practice changes     on her/his own unit. Another unit in that service line or under the same Service Line     Administrator will serve as a comparison unit. Data collection will be conducted again after     4 and 12 weeks. At the 12 week point, the NRC member will introduce the text + solicit staff     input for a plan on the comparison unit. Data collection will be conducted on the comparison     unit at 16 weeks, and again on both units at 24 weeks. At the 24 week point, additional units     will be added and the process repeated until all units represented on the NRC have been     included.      Outcome measures will include: EBP belief and EBP implementation scales (Melnyk &     Fineout-Overholt, 2003); EBP knowledge cognitive test; # of lit searches conducted by unit RN     staff ; # of requests for library support for lit searches or to obtain search-related     articles: # of unit clinical policies with documented levels of evidence & research     references. EBP belief, EBP implementation and EBP knowledge variables will be analyzed at     both individual and unit levels of analysis. All other variables will be measured at the unit     level of analysis. Additional unit level variables will include the following data collected     annually as part of the National Database for Nursing Quality Indicator (NDNQI) RN     satisfaction survey: satisfaction with RN-RN interaction, satisfaction with autonomy,     satisfaction with practice decision-making, perceived quality of care delivered on the unit.      The primary statistical procedures for analysis will be ANCOVA, ANOVAwith repeated measures,     and logistic regression.   "
212870|NCT00636064|"     The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib     therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass     surgery   "
212871|NCT00636077|"     The purposes of this study are to determine if the performance of a dialyzer depends on how     tightly the hollow fiber membranes are packed in the housing of the dialyzer (the membrane     packing density) and if that dependence is a function of the dialysate flow rate. The study     will examine how efficiently three different sized molecules pass through a dialyzer membrane     at different dialysate flow rates in dialyzers with different membrane packing densities.     Transfer of urea, phosphorus and beta-2-microglobulin from blood to dialysate will be     measured during clinical hemodialysis using four different dialyzers, each used at three     different dialysate flow rates. The data derived from these measurements may provide insight     into the importance of membrane packing density as a design parameter for hemodialyzers and     if changing the membrane packing density might provide equivalent performance at a lower     dialysate flow rate.   "
212872|NCT00636090|"     The purpose of this study is to look at the genetic changes that RAD001 causes in prostate     cancer cells and how those changes relate to patients' response to RAD001 treatment.   "
212873|NCT00636103|"     Asthma is a long-term disease process with genetic, allergic, environmental, infectious,     emotional and dietary influences. The symptoms control are mainly using an inhaled drug,     avoiding triggers or taking preventive medicine. Although side effects are unlikely at low     dose of the asthma treatment, they have become apparent at the higher dose. Due to safety     concern, parents often turn to complementary and alternative medicine which they believe is     natural and safe and may help to reduce the conventional medication dosage.      There are number of reports that treatment with traditional Chinese herbs or formulas     resulted in significant improvement in lung function and reduction in the airway     hyper-reactivity reaction. Our study drug CUF2, was based on a classical formulae and had     been proven to have anti-inflammatory and immunomodulatory activities in laboratory and     animal studies.      With the pre-clinical evidence, this study aims to determine the effect of CUF2 on improving     the clinical symptoms, biochemical markers, and requirement of steroid dosage among children     with asthma.   "
213890|NCT00643461|"     The purpose of this study is to compare the clinical performance of three dental adhesive     systems used to bond Class V cavity fillings in adult teeth.   "
212876|NCT00636142|"     The aim of the study is to test whether neutralizing TNF-alpha with infliximab affects     insulin resistance and phenotypical manifestations of the metabolic syndrome as fasting     plasma insulin, total body fat, plasma lipid profile or vascular endothelial function in     obese male subjects.   "
212877|NCT00636155|"     The purpose of this research study is to see if the investigational drug EL625, when combined     with traditional chemotherapy (rituximab, fludarabine, and cyclophosphamide), is effective in     Persistent Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)   "
212878|NCT00636168|"     The purpose of the study is to determine if ipilimumab is effective in preventing or delaying     recurrence and prolongs survival after complete resection of high risk stage III melanoma   "
212879|NCT00636181|"     Six month at home positive pressure therapy study; which mode of therapy will lead to better     adherence and patient outcomes?   "
212880|NCT00636194|"     To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to     Alcon OptiFree Replenish Multipurpose Solution   "
212881|NCT00636207|"     A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast     (MK-0476) in participants with mild or moderate asthma.   "
212885|NCT00636259|"     This study provides compassionate use of bicalutamide (Casodex) at a 150-mg dose for subjects     with prostate cancer prior to it becoming commercially available. The patient will receive     bicalutamide 150-mg as long as the physician feels that the subject is benefiting from this     therapy and safety information is provided regularly to AstraZeneca. Treatment will be     discontinued after bicalutamide 150-mg becomes commercially available.   "
212886|NCT00636272|"     Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active     ongoing source of updated information on the long-term reliability and performance of BSC     commercially available leads and LATITUDE-enabled (wireless or wanded) pulse generators     (PGs).   "
212887|NCT00636285|"     The purpose of this Phase 1 study is to evaluate the safety and pharmacokinetics of BSYX-A110     in a small number of healthy adult volunteers. Following the demonstration of safety in     adults, this anti-Staphylococcal monoclonal antibody will then be evaluated in the target     population of hospitalized low birth weight neonates.   "
212888|NCT00636298|"     The purpose of this study is to test the drug bevacizumab in combination with cetuximab.     Because this combination has not been tested in cancer patients before, results will be     analyzed to see what effects the combination of bevacizumab with cetuximab has on esophageal     cancer.   "
212889|NCT00636311|"     The purpose of this study is to evaluate if the addition of Bortezomib (Velcade) to IGEV     combination (Ifosfamide, Gemcitabine and Vinorelbine) in patients with relapsed/refractory     Hodgkin's lymphoma increases the rate of complete remission (PET negativity) at     transplantation.   "
212890|NCT00636324|"     Despite widely used of nasal CPAP in preterm infants, uncertainties regarding aspects of its     application remain. Clinical indications vary greatly between institutions, especially when     combined with varieties of systems, devices, and techniques available. One of the     controversial aspects that needs to be clarified is the level of pressure which should be     used. The objective of the study is to compare the effectiveness of two ranges of nCPAP     pressure that are within the spectrum of current practice for post-extubation support in very     preterm infants.   "
212891|NCT00636337|"     Specific Aim 1: To assess the feasibility and acceptability of a home-based, computerized     cognitive training program with survivors of central nervous system-impacting pediatric     cancer (e.g. acute lymphoblastic leukemia, brain tumors).      Specific Aim 2: To estimate the effect size of this cognitive training program on measures of     attention and working memory in survivors of childhood cancer in order to determine whether a     larger-scale clinical trial is warranted.   "
212892|NCT00636350|"     - list item one, Peppers      We propose to evaluate bio absorption of pepper carotenoids in a red bell-pepper or     non-pungent green jalapeno pepper. The pepper will be provided in a cooked dish. The specific     aims of this study are: 1) to determine blood response kinetics of lutein following multiple     doses of non-pungent green jalapeno pepper with meals. 2) to determine blood response     kinetics of zeaxanthin/capsanthin following multiple doses of red bell pepper with meals. We     will feed 16 healthy man and women (50 - 65 y, females were at least one year post     menopause), each cooked green jalapeno pepper or red pepper for 4 days and donate blood     samples up to 21 days to determine blood response kinetics of xanthophylls following multiple     doses of pepper dishes.   "
212893|NCT00636363|"     To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba     vision Aquify Multipurpose solution   "
212894|NCT00636376|"     Head injury is the most common cause of mortality and acquired disability in childhood. It is     common to elevate the head of patients at risk for increased intracranial pressure, although     it is not clear if it is always beneficial. Every severe pediatric traumatic brain injured     patient will have an optimal head position that prevents rising pressure in the brain.   "
212895|NCT00636389|"     The Polyflux HD-C4 (Gambro Renal Products) is a new dialyzer based on the existing Polyflux H     membrane and dialyzer technology, but which achieves a performance comparable to Polyflux     210H in a significantly smaller device.      The objectives of this study are:        1. To compare and contrast small and large molecule removal by the Polyflux HD-C4 and          Polyflux 210H dialyzers under conditions of routine hemodialysis; and,        2. To compare and contrast the ease of use of the Polyflux HD-C4 dialyzer with that of the          Polyflux 210H under conditions of routine clinical use for hemodialysis.   "
241614|NCT01021540|"     To determine if H.P. Acthar Gel (repository corticotrophin) has the same anti-proteinuric     effects seen with the synthetic ACTH analogue in Europe.   "
212896|NCT00636402|"     This study was planned to compare vessel sealing system tonsillectomy (VSST) to the     traditional cold knife tonsillectomy (CKT) with special regard to intraoperative bleeding,     operative time, postoperative pain and hemorrhage.   "
212897|NCT00636415|"     CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of     elderly people. The aim of the present study was to compare the analgesic effect of     intra-articular bupivacaine and morphine in patients with knee osteoarthritis.      DESIGN AND SETTING: A randomized and double-blind study was performed at a Pain Clinic of São     Paulo Federal University.      METHODS: Thirty-nine patients with pain for more than 3 months and an intensity higher than 3     on a numerical scale (zero to 10) were included. G1 patients received 1 mg (1 ml) morphine     diluted in 9 ml saline by the intra-articular route, and G2 patients received 25 mg (10 ml)     0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee     flexion and extension angles were measured after administration of the drugs at rest and     during movement. The total amount of analgesic complementation with 500 mg paracetamol was     also determined.   "
212898|NCT00636428|"     The objective of our study was to compare the safety and efficacy of oral midazolam during     pediatric endoscopy.   "
212899|NCT00636441|"     This multi-center randomized Phase II study assigned HER2-negative early-stage breast cancer     patients to receive preoperative systemic chemotherapy in either a genomic-guided arm or a     non-guided arm. The genomic-guided method (Arm 1) used genomic expression profiling to     assign the preoperative therapy (Doxorubicin/Cyclophosphamide (AC) versus     Docetaxel/Cyclophosphamide (TC), while Arm 2 used random assignment to these two therapies.   "
212932|NCT00636883|"     The purpose of this study is to determine if the combination of Gemcitabine, Oxaliplatin and     Erlotinib in the treatment of patients with pancreatic cancer will provide increased clinical     benefits and improvement in their quality of life.   "
212900|NCT00636454|"     Osteoarthritis (OA) is the leading cause of disability in the United States. Studies have     shown that training patients to cope with pain improves physical and social functioning,     increases self-efficacy, and reduces psychological distress. However, this type of training     is not available to the vast majority of OA patients. This study will determine the     effectiveness of a training program for coping with pain that will be administered in     community medical practices.      A THIRD ARM OF THE TRIAL WAS FUNDED 09/09. TREATED PATIENTS WILL BE RANDOMIZED TO (1)A     4-MONTH COMPUTER-DRIVEN TELEPHONE PROGRAM TO ENHANCE MAINTANENCE OF TREATMENT GAINS OR     (2)USUAL CARE. THIS ARM WILL ONLY BE CONDUCTED AT THE STONY BROOK SITE.   "
212901|NCT00636467|"     The purpose of this study is to evaluate the quality criteria of the SLN detection technique     in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters     (rate of false negatives, rate of detection).      Eligible patients will only be registered (no randomization). The estimated inclusion period     is approximately 24 months. The duration of the research is 25 months (24 months for patient     inclusion + 1 month for reception of results). The maximum participation duration of each     patient is 1 month.      The number of patients required in this multicentric and prospective study is 240 (16     participating centers).   "
212902|NCT00636480|"     Determine the antimicrobial properties of a proposed new product and an already approved     product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.   "
212903|NCT00636493|"     Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is     effective in the treatment of retinal vein occlusion that has caused persistent macular edema     and decreased visual acuity.      Hypothesis: A fluocinolone acetonide sustained drug delivery implant will be a safe and     effective method to treat patients with macular edema and decreased vision from retinal vein     occlusion.   "
212904|NCT00636506|"     The purpose of this study is to assess the American Medical System's IPP 2005 inflatable     penile prosthesis implant in subjects receiving the implant for erectile dysfunction for ease     of patient operability and use, as well as ease of surgery for the physician.   "
212905|NCT00636519|"     The primary purpose of this study is:        1. To evaluate the model determined by the ability of botulism antitoxin (bivalent,          Aventis) to neutralize Botulinum toxin in the Extensor Digitorum Brevis model of muscle          paralysis in Stage A.        2. To assess the ability of botulism antitoxin (heptavalent, Cangene) to neutralize          Botulinum toxin in the Extensor Digitorum Brevis model of muscle paralysis in Stage B.   "
212906|NCT00636545|"     The primary objective is to determine the safety and maximum tolerated dose (MTD) of     Genasense administered as a 2-hour intravenous infusion once weekly (Part 1) and twice weekly     (Part 2) to patients with solid tumors.   "
212907|NCT00636558|"     Coxsackie A21 (CVA21) virus is to be administered by IV infusion to patients with Stage 4     melanoma, prostate and breast cancer. This is a dose escalation, safety study.   "
212908|NCT00636571|"     Primary Objective: To examine the effects of an exercise training program on cardiopulmonary     fitness in early-stage postoperative non-small cell lung cancer patients undergoing adjuvant     chemotherapy      Secondary Objectives:      Determine patients' adherence levels to such a program during adjuvant chemotherapy Explore     the effects of exercise training on treatment compliance and toxicity, and quality of life.      To explore the effects of exercise training on markers of inflammation (e.g., c-reactive     protein, immune response) in patients undergoing adjuvant chemotherapy for early-stage     non-small cell lung cancer   "
212909|NCT00636584|"     Whether use of SNP during cardiac surgery has any effect on thyroid function has not yet been     investigated in humans. The aim of this study was to investigate the effects of SNP     administration during the rewarming period of cardiac operations on circulating levels of     thyroid hormones.   "
212910|NCT00636597|"     This study is a prospective evaluation of patients with occult (hidden) GI bleeding without     iron deficiency. Such patients usually undergo a diagnostic colonoscopy as a standard of     care. The study is aimed to determine any UGI-source of occult bleeding and to correlate UGI     symptoms with findings. Therefore, EGD is being offered to such patients as part of research.     We proposed to enroll 200 consecutive patients referred to our GI-unit for expedited     diagnostic colonoscopy for positive FOBT.   "
212925|NCT00636792|"     This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and     safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed     or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects     may be sensitive or refractory to prior therapies, including rituximab.   "
214356|NCT00649584|"     This study will examine the safety profile of SGN-35 alone and in combination with     gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of     patients.   "
212911|NCT00636610|"     This was a randomized, placebo-controlled, double-blind study of vismodegib (GDC-0449) added     to biochemotherapy standard-of-care regimens for metastatic colorectal cancer (CRC), with     treatment until disease progression. Patients received either FOLFOX (FOL=leucovorin calcium     [folinic acid], F=fluorouracil, OX=oxaliplatin) or FOLFIRI (FOL=leucovorin calcium [folinic     acid] F=fluorouracil, IRI=irinotecan hydrochloride) chemotherapy with bevacizumab. The     decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and     patient. Patients were randomized to receive vismodegib or placebo and were stratified based     on the chemotherapy regimen chosen and whether or not Response Evaluation Criteria in Solid     Tumors (RECIST) measurable disease was present at baseline.   "
212912|NCT00636623|"     The present study was designed to analyse and compare the effects of Pilates exercises and     connective tissue massage in terms of pain intensity, pain pressure threshold and tolerance,     anxiety, progress, and health related quality of life in females with fibromyalgia (FM)   "
212913|NCT00636636|"     Gabapentin and pregabalin are treatments for some types of neuropathic pain, including     postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a     day for effective pain control. The purpose of this study is to determine whether a new     gabapentin tablet, which only needs to be taken once a day, is safe and effective for the     treatment of postherpetic neuralgia.   "
212914|NCT00636649|"     Night-Eating Syndrome (NES) is an eating disorder characterised by excessive eating at night,     sleep disturbance and morning anorexia. This 12-week study examines the effect of     escitalopram on symptoms of NES.   "
212916|NCT00636675|"     Clinical trials have identified interventions that reduce adverse outcomes such as falls in     nursing home (NH) residents but attempts to translate these into practice quality improvement     (QI) techniques have not been successful. Using a complexity science framework, our previous     RO1 showed that low connection, information flow, and cognitive diversity among NH staff     explains quality of care for complex problems such as falls. Our pilot of Connect, a     multi-component intervention that encourages staff to engage in network-building and use     simple strategies to make new connections with others, enhance information flow, and use     cognitive diversity, suggests that staff can improve the density and quality of their     interactions. This 5-year study uses a prospective, cluster-randomized, outcome assessment     blinded design, with NHs (n=16) randomized to either Connect and a falls QI program (Connect     + Falls) or QI alone (Falls). About 800 residents and 576 staff will participate. Specific     aims are to, in nursing homes: 1) Compare the impact of the Connect intervention plus a falls     reduction QI intervention (Connect+Falls) to a falls reduction QI intervention (Falls) on     fall risk reduction indicators (orthostatic blood pressure, sensory impairment, footwear     appropriateness, gait; assistive device; toileting needs, environment, and psychotropic     medication); 2) Compare the impact of Connect+Falls to Falls alone on fall rates and     injurious falls, and determine whether these are mediated by the change in fall risk     reduction indicators; 3) Compare the impact of Connect+Falls to Falls alone on complexity     science measures (communication, participation in decision making, local interactions, safety     climate, staff perceptions of quality) and determine whether these mediate the impact on fall     risk reduction indicators and fall rates and injurious falls. Cross-sectional observations of     complexity science measures are taken at baseline, at 3 months, at 6 months, and at 9 months.     Resident fall risk reduction indicators, fall rates, and injurious falls are measured for the     6 months prior to the first intervention and the 6 months after the final intervention is     completed. Analysis will use a 3-level mixed model to account for the complex nesting of     patients and staff within nursing homes, and to control for covariates associated with fall     risk, including baseline facility fall rates and staff turnover rates.   "
212917|NCT00636688|"     Healthy lifestyle factors are associated with maintenance of erectile function in men. To     determine the effect of weight loss and increased physical activity on erectile and     endothelial functions in obese men.      Randomized, single-blind trial of 110 obese men without diabetes, hypertension, or     hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or     less on the International Index of Erectile Function (IIEF).      The 55 men randomly assigned to the intervention group received detailed advice about how to     achieve a loss of 10% or more in their total body weight by reducing caloric intake and     increasing their level of physical activity. Men in the control group (n = 55) were given     general information about healthy food choices and exercise.   "
212918|NCT00636701|"     We hope to understand the properties of the motor cortex in the brain of people with stroke     using non-invasive magnetic stimulation.   "
212919|NCT00636714|"     There is current evidence that maintaining ICU patient's blood sugar between 4.4-6.1 saves     lives. However, this is difficult to do in the ICU and carries risks of lowering the blood     sugar too much. In addition, the best way to achieve this control is not known. Many strict     nomograms that provide a standardized approach for nurses have been developed and validated,     including one here at SMH. However, these nomograms cannot apply to all patients at all     times, especially ICU patients whose needs are rapidly changing. ICU nurses are at the     bedside constantly, are very familiar with their patient's needs, and have decades of     experience in titrating medication doses without a nomogram to achieve a pre-determined     response (i.e. medications to achieve pre-selected blood pressure). Indeed, once the bedside     nurse has bought into the importance of the concept of tight glucose control and have been     introduced to the nomogram here at SMH, their experience and intuition may be more adaptable     to the changing needs of the patient than an inflexible paper nomogram. This study will     compare glucose control using our current standard nomogram versus no nomogram (i.e. nurse     directed) in order to determine whether the nomogram should continue to be used.   "
212920|NCT00636727|"     Many patients suffer from a disorder known as temporomandibular joint dysfunction. This     disorder has jaw joint pain and limited function as key elements. Many treatments have been     advocated over the last 40 years, many of them deleterious. Currently treatment can be     divided into four categories. The first is non-surgical and involves vocal rest, soft diet,     heat, anti-inflammatory medications, muscle relaxants, splint therapy and physical therapy.     All patients benefit to some degree utilizing one or more non-surgical approaches.     Controversy exists with respect to which of the next three categories of treatment is ideal.     Some advocate arthrocentesis which involves placing two small needles into the joint to allow     irrigation and instillation of anti-inflammatory medication. This is a minimally invasive     procedure performed under local anesthetic alone or with intravenous sedation. Others     advocate arthroscopy which involves placing an arthroscope (a thin tube about 2mm in diameter     with optical elements allowing one to see inside a joint) to visualize the inside of a joint.     Furthermore the joint can be irrigated, scar bands removed, ligaments stretched and     medication instilled. This is performed under a general anesthesia. Depending on the study,     success for both arthrocentesis and arthroscopy has been reported to be about 80-90%. Still     there are others who recommend arthroplasty which is an open joint surgical procedure that     allows the surgeon to enter the joint and directly repair or remove the damaged cartilage     disc within the joint. This is performed under a general anesthesia. Similar success rates of     80-94% have been reported. It is clear that some patients only require arthrocentesis, others     arthroscopy and others arthroplasty. We currently do not have any real mechanism of     predicting which patients will benefit the most from which procedure.      This study will enable patients undergoing each procedure to be followed closely with the     hope that we can determine objective factors that will allow us to stratify patients into one     of the three surgical options: arthrocentesis, arthroscopy or arthroplasty. Our current     approach is empiric and typically proceeds from arthrocentesis to arthroscopy to     arthroplasty. All patients in this study will be offered the opportunity to have     arthrocentesis performed. It is anticipated that a minority will achieve long-term benefit in     terms of pain and function. We hope to be able to identify those factors which will predict     which patients will benefit so that future patients selected to have arthrocentesis will have     much higher success rates. Patients who fail to improve with arthrocentesis or who initially     decline that procedure will be offered the opportunity to undergo arthroscopy. It is     anticipated that a majority of patients will achieve long-term benefit in terms of pain and     function. Again it is hoped that we can identify those factors which will predict which     patients will benefit so that future patients selected to have arthroscopy will have even     higher success rates. Patients who fail to improve with arthroscopy or who initially decline     both arthrocentesis and arthroscopy will be offered the opportunity to undergo arthroplasty     provided that clinical and radiographic evidence exists to support the presence of either a     diseased or displaced cartilage disc.      Our ability to adequately treat patients with temporomandibular joint dysfunction will be     significantly improved if we can better stratify patients and follow an evidence based     surgical algorithm that provides the greatest opportunity for success while reducing     potential complications. Each of these surgical procedures is the standard of care throughout     the USA but unfortunately the choice of which procedure to perform is often empiric and     guided more by training and surgical experience.   "
212921|NCT00636740|"     The objective of MER-101-03 is to examine the effects of two different dosing regimens of     MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be     monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be     enrolled will be those who have not received any previous bisphosphonate therapy. The study     will be carried out on prostate cancer patients who are no longer on hormone therapy.     Treatment in the study will be for a 2-month period.   "
212922|NCT00636753|"     The purpose of the study is to determine whether antipsychotic treatment is influence     psychiatric patients due to endocrine and metabolic status and quality of life.   "
212923|NCT00636766|"     The aim of the present study is to examine the atherosclerotic plaque stability using in vivo     and in vitro techniques and to investigate the influence of exercise, anti-diabetic,     lipid-lowering and cannabinoids receptor antagonists on atherosclerotic plaque texture in     patients with cardiovascular risk and animals prone to atherosclerosis.   "
212924|NCT00636779|"     The Bravewell Integrative Medicine Research Network (BraveNet) is a newly formed     practice-based research network of nine leading integrative medicine centers around the U.S.     collaborating in clinical outcomes research to increase the knowledge and evidence-base of     integrative medicine.   "
212926|NCT00636805|"     1. Primary Objective:             -  To determine the efficacy and tolerability of palonosetron and dexamethasone in               preventing acute CINV in brain tumor patients during the first 24 hours of               receiving Irinotecan /Bevacizumab regimens.        2. Secondary Objective             -  To determine the safety and tolerability of palonosetron in brain tumor patients.             -  To determine the effects of glucocorticoid and anticonvulsants on the efficacy of               palonosetron.             -  To determine the efficacy of palonosetron and dexamethasone in preventing delayed               CINV in brain tumor patients during days 2-5.             -  To determine if patients receiving palonosetron have less fatigue than baseline.   "
212927|NCT00636818|"     The primary objective of this clinical study is to assess overall safety and tolerability as     measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation     to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of     Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity     Disorder (ADHD).   "
212928|NCT00636831|"     The purpose of this study is to determine whether prophylactic antibiotic use in inguinal     hernioplasty are effective in prevention of infectious complication.   "
212929|NCT00636844|"     To identify patients that are at risk of heart damage after receiving chemotherapy     (adriamycin).   "
212930|NCT00636857|"     The proposed study will focus on anesthesia and anesthesia-induced hypotension as a possible     cause for postoperative fluid retention and hyponatremia, and investigate gender differences     in this response.   "
212970|NCT00637377|"     This study is a phase III, double-masked, randomized, study of the efficacy and safety of     VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately     1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.   "
212933|NCT00636896|"     This study is designed as a 3 week, randomized, double blind, placebo controlled, trial.     Olanzapine and modafinil will be titrated to 10mg and 200mg respectively. Feeding lab     assessments will be conducted at baseline and endpoint. Assessments of hunger/satiety,     kilocalories consumed and weight will be obtained. Plasma ghrelin and PYY3-36 levels will be     drawn at baseline and endpoint prior to breakfast and two hours post.      Study hypothesis: The modafinil/olanzapine group will gain less weight than the     olanzapine/placebo group over three weeks of drug intake.   "
212934|NCT00636909|"     The purpose of this study is to provide allogeneic stem cell transplantation to patients who     have not traditionally undergone this procedure because of it high incidence of treatment     related side effects. We hope to decrease these side effects by decreasing the chemotherapy     dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone     marrow is not completely eliminated) and by using donated stem cells to treat cancer of the     blood.   "
212935|NCT00636922|"     The main goal of this study is to assess the safety and tolerability of RAD001 in combination     with low-dose cytarabine in acute myeloid leukemia patients unfit for intensive chemotherapy.     The secondary goals are to investigate the likely causes of drug response or failure.   "
212936|NCT00636935|"     To explore the effects of corticosteroid therapy on pulmonary fibrosis and potentially     pneumothorax in patients with mild PCP (pO2 >70mmHg) combined with the standard of care     treatment of antibiotic therapy.   "
212937|NCT00636948|"     The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces     the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of     the rectum for cancer.   "
212938|NCT00636961|"     This study evaluated the effect of QAB149 on dynamic and static hyperinflation,     breathlessness, and health status in COPD patients   "
212939|NCT00636974|"     To determine and compare the effective intrathecal dose of levobupivacaine, ropivacaine and     bupivacaine for 50% of patients in lower limb surgery   "
212940|NCT00636987|"     The purpose of this study is to further evaluate the long-term safety and effectiveness of     the Biocor and Biocor Supra Valves.   "
212941|NCT00637000|"     The purpose of this study is to compare the presence, degree, time course and profile of     opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine     or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome     measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal     Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate     an opioid withdrawal syndrome.   "
212942|NCT00637013|"     The study aims at determining the effectiveness and cost-effectiveness of surgical management     of subacromial impingement (including partial tears) compared to conservative treatment. The     research setting is prospective, randomised, and controlled.      The aim of the study is to search out evidence based data of indications for subacromial     decompression. The investigators also aim at offering patients the most efficient and     effective treatment and reduce the number of operations that do not have sufficient     effectiveness. The data obtained will facilitate developing guidelines for referrals to a     specialist when subacromial impingement is suspected.      The investigators hypothesise that there are subgroups of patients suffering from subacromial     impingement that benefit from surgery whereas other subgroups are best treated     conservatively.   "
212943|NCT00637026|"     A pre-surgery study to assess changes that occur in human breast cancer material and normal     skin after a short course of treatment with Iressa.   "
212944|NCT00637039|"     The main purpose of this study is to explore the safety and tolerability of multiple     ascending doses (MAD) of AZD8931 in patients with advanced solid malignancies   "
213017|NCT00637988|"     This study evaluates PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's     metaplastic tissue. All patients will have a baseline endoscopy with multiple biopsies. The     patients will then be receive four dosing regimens (esomeprazole, esomeprazole and aspirin,     esomeprazole and rofecoxib, or rofecoxib alone) consecutively each for a 10 day dosing     period, whilst undergoing further follow up endoscopies and multiple biopsies.   "
212945|NCT00637052|"     This is a 2-phase study during which patients with select myeloid leukemias or advanced     myelodysplastic syndrome (MDS), who have failed, refused or are not eligible for standard     treatment, will receive investigational study drug ARRY-520.      The study has 3 parts. The first phase of the study, Phase 1, has 2 parts. In the first part     of Phase 1, patients with select myeloid leukemias or advanced MDS will receive increasing     doses of study drug on different schedules in order to achieve the highest dose possible that     will not cause unacceptable side effects. Approximately 30 patients (per schedule) from the     US will be enrolled in Part 1 (Completed). In the second part of Phase 1, patients with     advanced MDS will receive the best dose of study drug and schedule determined from the first     part of the study. Approximately 10 patients from the US will be enrolled in Part 2     (Completed).      In the third part of the study, Phase 2, patients with acute myeloid leukemia (AML) or     advanced MDS will receive the best dose of study drug and schedule determined from the first     part of the study and will be followed to see what side effects the study drug causes and to     see what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from     the US will be enrolled in Part 3 (Withdrawn).   "
212946|NCT00637065|"     Over time, patients with fibrosing or interstitial lung disease (ILD) can develop high lung     blood pressures (pulmonary hypertension), and this is associated with poorer prognosis and     survival. It is thought that development of PH contributes to the deterioration and death of     patients with ILD. Endothelin-1 (ET1) is a substance contributing to the development of both     PH and ILD. Bosentan is a drug blocking the action of ET-1 by binding to its receptors.     Bosentan clearly benefits patients with PH of unknown cause, or related to other diseases     (such as heart conditions, or HIV) both alone and in combination with other treatments. In     patients with fibrosing lung disease and PH, there have been no controlled treatment studies.     Clearly it is important to evaluate the effectiveness of bosentan in these patients.      This study aims to determine the ability of bosentan to reduce high blood pressure in the     lungs (pulmonary hypertension) in patients with scarring (fibrosing) lung disease. It is a     placebo-controlled double blinded study for 16 weeks (and it is proposed to follow patients     in a 16 week open-label phase with bosentan therapy).   "
212947|NCT00637078|"     The objective of this study is to assess if the implementation of a treatment algorithm     including initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination and     subsequently a low dose DHP-CCB/statin combination will improve the management of     hypertension/hypercholesterolemia compared to guidelines-base management at family practices.   "
212948|NCT00637091|"     The purpose of this study is to investigate the response rate of cetuximab plus irinotecan     every 2 weeks in patients harboring wild-type KRAS with and without detectable     EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.   "
212949|NCT00637104|"     The main objective of this study is to assess the safety and effectiveness of the TiN-coated     MAR-Tyn stent in maintaining minimum lumen diameter in de novo native coronary artery lesions     as compared to an uncoated control cobalt-chromium balloon-expandable stent (Vision, Abbott     Vascular). Both stents are mounted on a Rapid Exchange Stent Delivery System.   "
212950|NCT00637117|"     The purpose of the study is to gather data on feasibility and on immune and clinical efficacy     of intratumoral dendritic cell (DC) vaccination in combination with local radiotherapy in     patients with recurrent lymphoma   "
212951|NCT00637130|"     The purpose of this study is to compare the safety and IOP-lowering efficacy of various low     dose travoprost formulations in patients with open-angle glaucoma or ocular hypertension.   "
212952|NCT00637143|"     The purpose of this study is to compare renal transplant recipients on cyclosporine     maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to     renal outcomes.   "
212953|NCT00637156|"     The purpose of this clinical investigation is to assess the safety and effectiveness of using     the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc     disease at two adjacent levels of the cervical spine, with overall success being the primary     endpoint of the clinical trial. The primary objective is to show non-inferiority of the     investigational device to the control treatment. If non-inferiority is established,     superiority will also be examined as the secondary objective.   "
212954|NCT00637169|"     Study Question: In infants who are born at gestational ages of 23 0/7 to 27 6/7 weeks, does     lowering the concentration of supplemental oxygen to target an arterial oxygen saturation by     pulse oximetry (SpO2)of 85-89% compared with 91-95%, from the day of birth until the baby's     first discharge home, increase the probability of survival without severe neurosensory     disability to a corrected age of 18 months?   "
212955|NCT00637182|"     The purpose of this study is to look at the effect of anastrozole (ZD1033, Arimidex™) in     reducing gynecomastia in pubertal boys treated with placebo in Trial 1033US/0006 (another     anastrozole study).   "
212956|NCT00637195|"     Infection with human papillomavirus (HPV) has been clearly established as the necessary cause     of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and     safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals'     HPV vaccine GSK580299 in healthy female subjects.   "
212957|NCT00637208|"     Patients with varicocele in whon early prostate cancer will be found will undergo venographic     embolization of both spermatic veins. The study hypothesis is that this procedure will induce     a gradual regression of the prostate volume that may decrease prostate cancer cells. Close     follow-up will ensure that necessary therapy will be provided if needed according to clinical     criteria. Results in terms of prostate size PSA level and tumor size will be recorded.   "
212958|NCT00637221|"     This is an open label exploratory study to investigate the safety and effects of a single     dose of NPL-2009(50 mg - 150 mg) on Prepulse Inhibition (PPI) Tests and Continuous     Performance Tasks (CPT) in adults with Fragile X Syndrome   "
212980|NCT00637507|"     The investigators have recently demonstrated the beneficial effects of combined     high-frequency oscillation (HFO) and tracheal gas insufflation (TGI) on the respiratory     physiology [1,2] of patients with severe acute respiratory distress syndrome (ARDS)     (NCT00416260). Preliminary short-term survival results were also encouraging. Consequently,     in the present clinical trial, the investigators intend to increase the size of the studied     population, in order to evaluate the effect of HFO-TGI on survival with adequate statistical     power. Furthermore, the investigators intend to elucidate the mechanism of the     HFO-TGI-related physiological benefit.   "
212959|NCT00637234|"     Over recent years an approach with the adjunctive administration of various anticonvulsant     drugs has been discussed and a limited number of open and controlled studies were performed     for carbamazepine, valproic acid, and lamotrigine. While the latter shows promising effects     in the long run it has some handling difficulties in the acute treatment of acute psychotic     exacerbations. Valproic acid has shown inconsistent effects in schizophrenia with no     significant effects in a recent controlled study. Although still controversially discussed,     carbamazepine was found to offer beneficial effects in the treatment of schizophrenia.     Nonetheless, data on these effects are limited by small sample sizes or poor design of most     of the respective studies. Furthermore, the complex pharmacological interactions of new     atypical neuroleptics with carbamazepine underline the necessity of alternative strategies in     adjuvant treatment of schizophrenia as well as in combined treatment of bipolar disorders     with mood stabilizers and neuroleptics.      Oxcarbazepine (OXC) is a new anticonvulsant drug that acts as a pro-drug for the     10-monohydroxy metabolite (MHD), an active metabolite also of carbamazepine that is suggested     to be responsible for most of its therapeutic actions. Therefore, the pharmacological action     of OXC is very well comparable to carbamazepine whilst there are fewer unwanted side effects     of OXC regarding eg. skin rush, and effects on blood compounds or cardiotropic effects.      The effects of OXC on cytochrome CYP3A4 and CYP3A5 are moderate and UDPGT is only slightly     affected by OXC, which leads to less interaction with other compounds on a pharmacokinetical     level.      In psychiatry, the few studies published until now report positive effects of OXC in bipolar     disorders. With regards to our own clinical observations, OXC has shown potential beneficial     effects as an adjunct in the treatment of schizophrenia as well that require further     evaluation in a controlled study design.   "
212960|NCT00637247|"     The purpose of this study is to determine if imexon in combination with gemcitabine could     improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer     that has spread to other organs such as the liver or lungs. The study will also look at the     safety of the combination as compared to gemcitabine alone. Participants in the study will be     randomly assigned to either treatment and neither the participant or their doctors will know     which treatment they will be receiving.   "
212986|NCT00637585|"     To examine the relative potency, onset of action and duration of action of fexofenadine HCl     180 mg (ALLEGRA) and desloratadine 5 mg (CLARINEX) as compared to placebo on skin wheals and     flares induced by histamine.   "
212987|NCT00637598|"     The purpose is to develop digital tomosynthesis to improve the detection of breast cancers.     The aims are optimizing digital mammography and tomosynthesis acquisition, creating     visualization tools, prospective pilot studies to evaluate radiologist performance, and     computer-aided detection.   "
212961|NCT00637260|"     Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson     disease (PD), but it is not optimally effective for controlling every motor sign and adverse     events are not so infrequent Therefore, other approaches should be considered.We identified     the motor cortex as a possible candidate and therefore we propose a double-blind randomized     prospective study in 20 Parkinson patients in order:        -  to test the efficacy of epidural motor cortex stimulation in Parkinson disease (primary          endpoint: UPDRS III at 12 months at the end of the cross-over)        -  to find out optimal electrode position and optimal stimulation parameters   "
212962|NCT00637273|"     This study will compare the benefits of exenatide once weekly treatment to those achieved by     the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2     diabetes is managed with metformin therapy alone. The safety and tolerability of the three     treatment regimens will also be compared.   "
212963|NCT00637286|"     The purpose of this study is to determine how useful and effective the use of ZOMIG-ZMT™     (zolmitriptan) 5.0 mg and ZOMIG® Nasal Spray (zolmitriptan) 5.0 mg is for patients, in     treating migraine over a period of 6 months   "
212964|NCT00637299|"     The purpose of this trial is to verify if an osteopathic treatment added to usual pulmonary     rehabilitation trial is able to improve the walking ability of COPD patients and if there is     any influence on lung functionality.   "
212965|NCT00637312|"     The purpose of this study is to establish the safety and effectiveness of the Advent™     Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating     degenerative disc disease at a single-level in the cervical spine (from C3 to C7) following     cervical discectomy in skeletally mature patients (at least 18 years of age).   "
212966|NCT00637325|"     This is an open-label, randomised phase III, multicentre, Italian study designed to     investigate the role of trastuzumab in patients with locally advanced and/or metastatic     breast cancer over expressing HER2 who received a first line chemotherapy containing     trastuzumab. The trial in divided in two studies: 1. The maintenance study will be conducted     in patients not progressing to a first line chemotherapy plus trastuzumab. 2. The 2nd line     study will be conducted in patients progressing to a first line chemotherapy plus     trastuzumab.   "
212967|NCT00637338|"     PF-04603629 is being investigated for the treatment of Type 2 diabetes mellitus (T2DM).     Specifically, PF-04603629 is a protein that is a combination of exendin-4 (a glucagon-like     peptide-1 (GLP-1) mimetic currently marketed as Byetta®) fused to human transferrin (a     naturally occuring protein) in order to increase the concentration of exendin-4 in the blood.     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and     pharmacodynamics of PF-04603629 following multiple escalating subcutaneous doses in adult     subjects with T2DM.   "
212968|NCT00637351|"     GSK Biologicals is working on the development of a vaccine to protect elderly people from     bacterial pneumonia. Diagnostic of bacterial pneumonia is difficult, and for the future     studies in that project, it would be useful to have some easy non invasive tests. New     clinical read-outs are needed to detect and identify the causative pathogen. These assays     will be based on specific antigen detection in the urine or specific pathogen DNA detection     in the blood. Technical and clinical validation of these assays will be realised at later     stage with samples coming from epidemiological and/or phase III studies.      To allow the development of such tests in GSK Biologicals laboratories, urine and blood     samples are needed from subjects aged 65 or above who have diagnosed pneumonia.      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep     2007.   "
212981|NCT00637520|"     We hypothesize that insulin resistance is characteristic of nonalcoholic fatty liver disease     as compared to age, gender, non-diabetic BMI-matched control subjects, both healthy and those     with non-cirrhotic, non-steatotic liver disease.   "
212982|NCT00637533|"     Lumbar sympathetic blocks are part of the standard of care for treating patients with     sympathetically-maintained pain (e.g. in complex regional pain syndrome or reflex sympathetic     dystrophy- RSD). In these patients lower extremity pain can be reduced or abolished     temporarily by blocking sympathetic nerves by doing a lumbar sympathetic block. Patients who     respond only transiently to sympathetic blocks often choose between potentially dangerous     lumbar sympathetic block with neurolytic agents, surgical sympathectomy, continued severe     refractory debilitating pain or other risky invasive surgical procedures such as spinal cord     electrical stimulation.. It is hypothesized that Botulinum Toxin Type A (BTA) injected in a     lumbar sympathetic block can provide extended sympathetic blockade and thus pain relief. This     pilot study aims to see if BTA can be used safely in lower extremity sympathetic blocks, and     might be useful in providing prolonged pain relief.   "
214958|NCT00657514|"     After 6 weeks of maximal Ranolazine therapy, tissue hemoglobin desaturation kinetics will     change compared to placebo in patients with chronic angina and peripheral arterial disease.   "
212969|NCT00637364|"     This is an open-label, non-randomized, single-center, therapeutic trial in patients with AJCC     Stage III or IV pancreatic cancer with tumor related abdominal and/or back pain to evaluate     the safety of high intensity focused ultrasound therapy using the FEP-BY02 HIFU system for     palliation of pancreatic cancer-related pain. Patients meeting all eligibility criteria     without any exclusion criteria will be offered an opportunity to participate in the study.     After obtaining informed consent a baseline history, physical examination, laboratory     studies, and any additional imaging studies needed will be performed.      The major theoretic risk to the patient with this procedure is the development of acute     pancreatitis. If acute pancreatitis were to develop, it should become clinically evident by     day 3 following HIFU ablation. Therefore, the initial phase of this pilot study is designed     to allow a sufficient interval between HIFU treatments to identify whether this theoretic     risk will manifest clinically. Previous clinical experience in China suggests that HIFU of     pancreatic tumors is safe without risk of developing severe acute pancreatitis.      Patients treated with HIFU will have approximately 15-20% of the tumor volume treated per     session. The first 5 patients (feasibility study) will receive their first HIFU treatment     followed by a 3-5 day interval for observation.      Following the feasibility study the results will be reviewed with the FDA. If no serious     adverse events are encountered, and the FDA agrees with continuing the study, then the next 5     patients will be treated with an interval of 2-3 days between each treatment. If no serious     adverse events are encountered in this group, then the next group of 5 patients will be     treated at intervals of 1-2 days between each treatment.   "
212971|NCT00637390|"     Ovarian cancer cannot grow without recruiting new blood vessels. Studies in humans have     identified a novel cell population, termed vascular leukocytes (VLCs). While VLCs are not     cancer cells, they support the growth of ovarian cancer cells by stimulating the growth of     new blood vessels which provide the cancer with nutrients. VLCs make a protein termed CD52.     An antibody therapeutic, Alemtuzumab (also know as Campath), that kills cells that make the     CD52 protein has been successfully used to treat certain lymphomas (a type of blood cell     cancer) that make CD52 protein. The purpose of this study is to determine if Alemtuzumab     given subcutaneously (under the skin)can be safely given to patients with ovarian, fallopian,     or primary peritoneal cancers to kill VLCs and determine if Alemtuzumab, by eliminating VLCs,     can restrict tumor growth or increase response rates to chemotherapy given after the     discontinuation of chemotherapy.   "
212972|NCT00637403|"     To determine the pharmacokinetics and safety of megestrol acetate after a single oral 300 mg     dose of megestrol acetate concentrated suspension in healthy subjects, and subjects with     varying degrees of renal impairment   "
212973|NCT00637416|"     This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary     control alone will improve pediatric hoarseness symptoms.   "
212974|NCT00637429|"     Human immunodeficiency virus/Hepatitis B virus (HIV/HBV) co-infections are frequently     observed due to shared routes of transmission, with reported figures indicating 6-9% of     HIV-infected individuals in developed countries are chronically infected with HBV. HIV     infection impacts on the natural progression of HBV infection, increasing levels of HBV     replication and the risk of liver-associated mortality. Liver diseases associated with HBV     are affected by the antiviral drugs used for HIV infection (toxic side effects), the current     immune function in the patient, by improvements in the immune system brought about by control     of the HIV infection, and by the development of resistance to the antiviral agents used for     both the hepatitis B and the HIV infection. Co-infection with HBV increases the risk for     hepatotoxicity in those individuals receiving highly active antiretroviral therapy (HAART)     for their HIV infection.      This study will recruit patients who are co-infected with HIV and HBV, and are currently     taking or who are about to commence HAART. The study cohort will include HIV-HBV co-infected     individuals from the Alfred Hospital, the Royal Melbourne Hospital and high case load GP     clinics who are referred to the Alfred Hospital.      The aim of the study is to investigate chronic hepatitis B and its impact on the progression     of liver disease in HIV-infected persons receiving HAART.      This will be achieved by 6 monthly assessment with medical history, physical examination,     bloods for markers of liver disease and hepatitis B activity and completion of questionnaires     to measure adherence and alcohol use.   "
212975|NCT00637442|"     Examination of the correlation between the cerebral bloodflow and the clinical change under     treatment with Reminyl retard® and the prediction of clinical change by measuring the     cerebral bloodflow in patients with mild to moderate Alzheimer's Disease   "
212976|NCT00637455|"     To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on     computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized     objective measure of attention, accuracy and reaction time in healthy naval flight personnel.     Specifically, the primary objective is to compare the AVT overall (average of the 18 blocks)     mean change from baseline in total number of errors (commission errors + omission errors)     between fexofenadine HCl and cetirizine 10 mg. Safety of these single-dose treatments also     will be assessed.   "
212977|NCT00637468|"     The aim of the EAGLE Study is to compare the efficacy of conservative medical treatment and     local intraarterial fibrinolysis in patients with central retinal artery occlusion and to     evaluate benefit and risk for the patient of both therapies.   "
212978|NCT00637481|"     Chemoprevention is the use of certain drugs to keep cancer from forming. The use of     atorvastatin (Lipitor) may prevent breast cancer. This randomized phase I trial is studying     the best dose of atorvastatin in preventing breast cancer in women at increased risk for     breast cancer.   "
212979|NCT00637494|"     Approximately 450 patients will be randomized to receive mifepristone or placebo for 7 days     followed by antidepressant. The purpose is to compare the efficacy of mifepristone followed     by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in     patients with a diagnosis of psychotic depression.   "
213033|NCT00626782|"     Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of     trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing     epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include     late bleb leaks, hypotony and infection.   "
212983|NCT00637546|"     Type 2 diabetes is one of the fastest growing public health problems in both developed and     developing countries. It is estimated that the number of people with diabetes in the world     will double in coming years, from 171 million in 2000 to 366 million in 2030.The role of     physiotherapy in diabetic care is to reduce immobilisation effects, to maintain functional     capacity and to minimise diabetes-related complications. The physiotherapist also has a role     in providing advice about exercise and daily living activities. The fundamental principle of     rehabilitation is to improve quality of life while diminishing the health care burden. By     reducing the heightened risk of falling, the fall related injuries and the fear of falling     one could improve quality of life in diabetic patients and reduce health care costs.      The goal of this study is to investigate the effectiveness of gait and balance training in     pre frail subgroup diabetes patients. Our program is based on recommendations of Robertson et     al.(2002) and Page et al.(2002) The investigators randomly assign patients in a control group     (no treatment) or in a treatment group. The treatment program consists of two group sessions     per week over 12 weeks. Patients were encouraged to perform specific home exercises. After     this 12-week program, patients were asked to continue their exercises. The effect of the     treatment will be evaluated after the treatment program and after a 6-month follow up.   "
212984|NCT00637559|"     This study looks the intragastric and intraesophageal pH in patients with documented     Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three     times daily, esomeprazole 20 mg three times daily.   "
212985|NCT00637572|"     Explore weight gain in HIV-positive patients who have weight loss associated with     AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either     megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate     oral suspension original formulation   "
212988|NCT00637611|"     The primary objective of this study is to determine the efficacy and onsets of action of     single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to     placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine     hydrochloride 180 mg, montelukast sodium 10 mg, and placebo   "
212989|NCT00637624|"     In this study we want to investigate the efficacy of N-acetylcysteine (NAC), which is an     anti-oxidant, in the prevention of cisplatin-induced neural toxicity, in patients treated for     lung cancer with chemotherapy containing cisplatin.   "
212990|NCT00637637|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Indinavir and     ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. It is not yet known whether external-beam radiation therapy is more effective with or     without indinavir and ritonavir in treating patients with brain metastases.      PURPOSE: This randomized phase II trial is studying external-beam radiation therapy alone to     see how well it works compared to external-beam radiation therapy given together with     indinavir and ritonavir in treating patients with brain metastases.   "
212991|NCT00637650|"     The purpose of this study is to study the outcome of patients after ureteroscopy in which all     fragments remaining after holmium laser lithotripsy were retrieved compared to those where     small, insignificant fragments were left for spontaneous passage.   "
212992|NCT00637663|"     This is a randomized, open-labelled, prospective 96-week study comparing the antiviral     efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining     lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.   "
212993|NCT00637676|"     An open randomized, prospective, single center; parallel group trial to compare efficiency     and safety of PleurX-Pleural Catheter versus standard surgical treatment in patients with     malignant pleural effusion and partial entrapment of the lung.   "
212994|NCT00637689|"     The purpose of this study is to see if recent guidelines proposed by the National Institutes     of Health for the diagnosis, staging, and response assessment of people with chronic GVHD can     improve our understanding of this complication. We will accomplish our goals by studying a     large number of people with chronic GVHD over several years using information collected from     health care providers, patients, laboratory studies and diagnostic tests. Several transplant     centers in the United States are collaborating on this project.   "
212995|NCT00637702|"     This is a Phase 1 study during which patients with advanced solid tumors will receive a new     formulation of investigational study drug ARRY-334543. Patients will receive increasing doses     of study drug in order to achieve the highest dose possible that will not cause unacceptable     side effects. The patients will be followed to see what side effects and effectiveness the     study drug has, if any, in treating the cancer. In addition, the effect of food on the new     formulation will be evaluated. Approximately 24 patients from Canada will be enrolled in this     study (Active, not recruiting).   "
212996|NCT00637715|"     Collection of the data on the safety and efficacy of the once daily administration of the     alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract     symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the     course of everyday practice   "
212997|NCT00637728|"     Purpose of the study is to compare the effects of megestrol acetate concentrated suspension     and placebo on caloric intake for the treatment of cancer-associated anorexia in patients     with lung or pancreatic cancer   "
212998|NCT00637741|"     The objective of this clinical investigation is to evaluate the long-term (up to 12 months)     outcome of the 200 mm long self-expanding nitinol EverFlex (ev3) stent in long     femoropopliteal lesions (TASC C & D) Is is the first time that the use of 200 mm long stents     will be evaluated in these lesions. It is expected that the outcome of the treatment with     this type of long stents will be better as the treatment of identical lesions lengths with     multiple shorter stents.   "
212999|NCT00637754|"     The registry will obtain information to determine the safety of sports participation for     patients with defibrillators (ICDs).   "
213000|NCT00637767|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.     Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances     to them without harming normal cells. A stem cell transplant using stem cells from the     patient may be able to replace blood-forming cells that were destroyed by the chemotherapy     and radiolabeled monoclonal antibody.      PURPOSE: This randomized phase II trial is studying how well high-dose melphalan works when     given with or without radiolabeled monoclonal antibody in treating patients with multiple     myeloma undergoing an autologous stem cell transplant.   "
213001|NCT00637780|"     This study will characterize the steady state pharmacokinetics of sulfasalazine delayed     release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study     will fulfill the post approval commitment to the FDA.   "
213002|NCT00637793|"     The purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of     decreased salivary flow associated with primary or secondary Sjögren's syndrome.      For each patient, the study includes four periods of treatment separated by a washout period     that may range from 4 - 8 days according to patient and site discretion. Each treatment     period includes two overnight stays in the clinic. One dose of study drug is taken during     each treatment period   "
213003|NCT00637806|"     To compare the effect of megestrol acetate concentrated suspension and placebo on caloric     intake in patients with cancer-associated anorexia.   "
213004|NCT00637819|"     A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active     disease who are refractory to cyclophosphamide   "
213038|NCT00626847|"     Glaucoma is a group of diseases in which visual loss occurs because of damage to the optic     nerve. Research has shown that certain genes may cause glaucoma in some cases. So far,     research has only been able to find the genes responsible for glaucoma in a small percentage     of people who have glaucoma. The purpose of this project is to study the genes in patients     with and without glaucoma to find additional genes that may be responsible for causing     glaucoma.   "
213039|NCT00626860|"     This study aims to determine if the vacccine can be used safely in patients with advanced     melanoma (cancer of the pigment cells) and whether the cells in this vaccine are capabale of     producing immune responses against your own cancer.   "
213005|NCT00637832|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab     tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming     normal cells. Giving rituximab together with combination chemotherapy and yttrium Y 90     ibritumomab tiuxetan may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with combination     chemotherapy and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed     follicular non-Hodgkin lymphoma.   "
213006|NCT00637845|"     A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg     twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD)     with continued heartburn symptoms with a course of therapy of 30 mg twice daily Lansoprazole.   "
213007|NCT00637858|"     Effect of different doses of tomato extract (contain Lyc-o-Mato 6% Oleoresin which Contain:     5, 15 mg lycopene , in addition to Beta-carotene (0.15%), phytoene, and phytofluene (1%); and     vitamin E (2%), phospholipids (15%), and phytosterols (0.6%) suspended in tomato oleoresin     oil) compared with synthetic lycopene on blood pressure and plasma lycopene levels in never     treated pre-hypertensive otherwise healthy subjects.   "
213008|NCT00637871|"     This study looks at the relationship in the dose of nolvadex and the incidence of     gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with     Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the     breast tissue adverse effects without reducing the efficacy of Casodex.   "
213009|NCT00637884|"     This is a single-center, prospective, randomized, double-blind, placebo-controlled, two-way     crossover study. A live cat challenge model will be used for exposing subjects to Fel d1.     Subjects who test positive for cat allergy symptoms during a priming cat exposure challenge     will be eligible to enter the treatment phase of the study. Baseline efficacy measures will     be obtained prior to the dispensing of study medication during both treatment periods. Cat     challenges will be initiated 1.5 hours following treatment with study medication.   "
213010|NCT00637897|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, docetaxel,, paclitaxel, and ixabepilone work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Paricalcitol may help chemotherapy drugs to kill more tumor cells by making tumor cells more     sensitive to the drugs.      PURPOSE: This clinical trial is studying the best dose and best way to give paricalcitol and     to see how well it works when given together with chemotherapy in treating patients with     metastatic breast cancer.   "
213011|NCT00637910|"     The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in     second line in wild-type EGFR tumour patients.   "
213012|NCT00637923|"     The purpose of this study is to determine if nitazoxanide in combination with peginterferon     alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in     treatment-naive patients.   "
213013|NCT00637936|"     Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as     opposed to normally 30%) on pulmonary gas exchange and other pulmonary complications after     abdominal surgery.      Background: Previous studies have shown possible beneficial effects of high perioperative     oxygen concentration on surgical wound infection and healing, but all pulmonary effects are     not clarified. Change in perioperative PaO2/FiO2 and shunt-fraction, measured by a gas     rebreathing technique, can describe pulmonary oxygenation. This could add knowledge to the     pulmonary effects of high vs. normal oxygen concentration.      Primary hypothesis of study: Perioperative use of a 80% oxygen concentration reduces the     PaO2/FiO2-index compared to 30% oxygen.   "
213014|NCT00637949|"     This safety study evaluated the incidence of gastrointestinal adverse events and edema in     patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator   "
213015|NCT00637962|"     To determine the local (cervico-vaginal) and systemic (whole body) safety of vaginal     immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period.   "
213016|NCT00637975|"     The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in     combination for the treatment of oncological neuropathic pain with two different strategies.   "
213202|NCT00641979|"     The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua     (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the     symptoms of seasonal allergic rhinitis (SAR).   "
213018|NCT00638001|"     The purpose of this study intend to evaluate the effectiveness of functional orthoses     (including custom-made insoles and shoes) for preventing and controlling repetitive     haemarthrosis in patients suffering of haemophilic ankle arthropathy, as well as the     orthoses' impact on foot health-related quality of life.   "
213019|NCT00638014|"     The primary objective is to establish if the Rapid Sternal Closure System (RSCS) improves     early postoperative recovery as manifested by decreased pain and improved pulmonary function.      Secondary objectives include evaluation of Rapid Sternal Closure System with regard to SWCs     (surgical wound complication defined as surgically treated sternal wound infection and     sternal instability/non-union) as outlined in the protocol.      For a given study endpoint, the null hypothesis will be no difference between the Rapid     Sternal Closure System group and the control group. The alternative hypothesis will be a     difference between 2 groups. The statistical objective of this study is to reject the null     hypothesis in favor of the alternative hypothesis.   "
213040|NCT00626873|"     RATIONALE: New diagnostic procedures, such as contrast-enhanced ultrasonography, may be an     effective method of finding ovarian cancer.      PURPOSE: This clinical trial is studying how well contrast-enhanced ultrasonography works in     diagnosing early-stage ovarian cancer in patients with an adnexal mass undergoing surgery to     remove the ovary.   "
213041|NCT00626886|"     The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and     effective in reducing the amount of narcotic pain medication needed to control pain during     the first 24 hours after herniorrhaphy.   "
213020|NCT00638027|"     Participants (n=20) will be identified at routine care visits performed at the Rochester     Multiple Sclerosis Center. Eligible participants will have MS by McDonald Criteria,7 and will     have a modified Ashworth spasticity rating8 of two or higher in at least one lower extremity     muscle group. Participants will be seen at screening, one, and three months, and will be     evaluated using the modified Ashworth scale,8 pendulum test,9 toe tapping test,10 manual     muscle testing,11 timed 25 foot walk,12 and Multiple Sclerosis Functional Composite.13 The     type and severity of any adverse events will be recorded using standard definitions.     Participants will be instructed to call between visits to inform the investigators regarding     any adverse events they experience. Follow-up will continue until all adverse events resolve     or stabilize.   "
213021|NCT00638040|"     The purpose of this study is to analyze the gene expression patterns associated with various     microenvironmental stresses in tumors to understand their roles in tumor progression and     treatment responses. To achieve this goal, we will perform gene expression analysis of the     tumor samples collected from an IRB-approved study (IRB #: 4516-05-2R2) International Phase     III Study of Chemoradiotherapy versus Chemoradiotherapy Plus Hyperthermia for Locally     Advanced Cervical Cancer directed by Dr. Mark Dewhirst. We will correlate the gene expression     signatures of different microenvironmental stresses with the measured physiological     parameters to understand their role in tumor progression, treatment response and clinical     outcomes.   "
213022|NCT00638053|"     The purpose of this study is to assess the prevalence of GHD in patients who sustain a head     injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH)     therapy in the treatment of GHD caused by trauma or head injury   "
213023|NCT00638066|"     According to high rate of vaginismus (about 10 percent) which leads to unconsummated marriage     (about 1 percent) and low efficacy for conventional treatments such as biofeedback therapy,     analgesic drugs and pain killers and surgical treatment, there`s necessity to find more     effective method.      In our previous study, injecting botulinum toxin in 23 patients cured 75% of them.Now we are     to make comparison between different doses of toxin injection and record the patient sexual     satisfaction.   "
213024|NCT00638079|"     To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625     mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in     healthy individuals.   "
213025|NCT00638092|"     The purpose of this trial is to determine whether iodide supplementation of neonates born     under 31 weeks gestation improves neurodevelopment measured at two years of age.   "
213026|NCT00638118|"     Examine the relative potency, onset of action and duration of action of fexofenadine HCl 180     mg (Allegra) and montelukast sodium 10 mg (Singulair) as compared to placebo on skin wheals     and flares induced by seasonal allergen.   "
213027|NCT00638131|"     There is little doubt of the necessity for further improvement in the prevention and therapy     of end-stage renal disease. Despite the success of ARB in treating diabetic nephropathy, not     all patients obtain satisfactory control of blood pressure, albuminuria and decline in renal     function. Experimental data have provided us with a rationale for the potential added     benefits of ET receptor blockade to the AII inhibition in diabetic renal protection.     Considering the nephroprotective effect of bosentan in diabetic rats, clinical studies are     warranted to assess whether ET receptor antagonism has additive renoprotective effects on top     of AII inhibition.   "
213028|NCT00638144|"     End stage HCV-related cirrhosis has become a major indication for liver transplantation (LT).     Unfortunately, recurrence of HCV infection on the liver graft occurs in almost all patients     following transplantation and causes a persistent infection that leads to chronic hepatitis     and cirrhosis in a significant proportion of patients. To date there is no effective way to     prevent HCV reinfection of the liver graft in the early phase after transplantation. . Early     passive immunotherapy with neutralizing antibodies against HCV should be considered for     preventing reinfection of liver transplanted patients associated with HCV. This approach is     well established in the case of patients undergoing liver transplantation for chronic     hepatitis B virus infection. Our purpose is to produce neutralizing monoclonal antibodies to     prevent reinfection of the liver graft.   "
213029|NCT00638157|"     multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin     (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the     treatment of SAIE   "
213030|NCT00626743|"     To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and     Amlodipine, phase I study in Hypertensive patient was designed.   "
213031|NCT00626756|"     Hypothesis: Fluid management guided by LiDCO doesn´t increase cumulative fluid balance and     shorten organ dysfunction compared to fluid management based on CVP and clinical judgment.   "
213032|NCT00626769|"     BACKGROUND: Recent evidences showed that the phytoestrogen genistein positively affects bone     metabolism with no clinically significant adverse effects in a cohort of osteopenic,     postmenopausal women. However, there is still a knowledge gap regarding the long-term safety     of genistein on the breast, the uterus, the thyroid gland and its efficacy in postmenopausal     women.      OBJECTIVE: To assess the safety profile of genistein on mammary and thyroid glands and     endometrium and cardiovascular apparatus and its effects on bone metabolism after a 3-year     therapy with pure, standardized genistein (54 mg/day).   "
213034|NCT00626795|"     An international, multi-centre, prospective three arm parallel-group, phase II proof of     concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7     days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2%     cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an     evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A     total of 664 patients will be enrolled in a stepwise manner according to age groups starting     with the oldest age group.   "
213035|NCT00626808|"     This is a retrospective cohort study of children included in a large medical insurance claims     database.   "
213036|NCT00626821|"     The main purpose of the study is to document real life experience on SenSura with focus on     skin condition and quality of life.   "
213037|NCT00626834|"     This is a Phase 1 safety/tolerably study to determine if there are clinically significant     interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent     with intravenous (IV) cocaine infusions.   "
213042|NCT00626899|"     Patients resuscitated from a cardiac arrest undergo therapeutic hypothermia as a treatment     option. Measuring the cardiac output in these patients is sometimes important, but difficult,     as these patients require an invasive device for measurement. Recently, a non-invasive device     based on pulse-contour analysis of the arterial pulse was developed (the Vigileo).     Hypothermia changes the pulse contour, so the performance of the Vigileo in patients with     induced therapeutic hypothermia is not known. Therefore we conduct this observational study     in which the cardiac output of the patients is measured with the traditional method and the     Vigileo simultaneously.   "
213043|NCT00626912|"     The PRET study aims at comparing two types of coils used in the endovascular treatment of     intracranial aneurysms. The first type made of platinum has been used for more than 15 years.     The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that     expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET     study is that the newer hydrocoil will be more effective and yet as safe as the older     platinum coil.   "
213044|NCT00626925|"     The purpose of this study is to evaluate the safety and efficacy of topiramate in reducing     drinking and heavy drinking frequency in problem drinkers. We hypothesize that at a dosage of     up to 200mg/day, topiramate will be well tolerated in this patient population and that,     compared to placebo treatment, topiramate will result in a greater reduction in the frequency     of both drinking days and heavy drinking days.   "
213045|NCT00626938|"     Sarcoidosis is a multi-systemic disorder, meaning that it can involve any organ in the body     and that its clinical presentation is highly variable. In 90% of all sarcoidosis cases the     lungs are affected. It is difficult to give a concise definition of sarcoidosis due to the     fact that its exact cause is still unknown. Consequently, diagnosing the disease is also     rather difficult. Up till now, sarcoidosis is generally diagnosed by using general clinical     methods to evaluate the status of the lung including a chest X-ray, lung biopsy and     bronchoalveolar lavage (BAL). However, some of these methods are considered to be rather     invasive and, even more important, non-conclusive. Therefore, the current study has been     designed to evaluate the use of a new technique, called SELDI-TOF mass spectrophotometry, for     the diagnosis of sarcoidosis. This technique enables the analysis of all enzymes present in     the blood of sarcoidosis patients which may hopefully lead to creating a disease-specific     protein-profile that may facilitate the recognition of sarcoidosis. Moreover, these results     will be compared with other currently used laboratory parameters.   "
213046|NCT00626951|"     The LMA Supreme is a new extraglottic airway device which brings together features of the LMA     ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal     leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA     ProSeal and the LMA Supreme in paralyzed anesthetized patients   "
213047|NCT00632385|"     To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were     not satisfied with rizatriptan therapy   "
213048|NCT00632398|"     RATIONALE: A multimedia education program for family caregivers that teaches simple methods     of touch and massage for the comfort of cancer patients at home may be effective in lowering     stress, reducing symptoms, and improving quality of life for patients; and may improve     caregiver satisfaction and self-efficacy.      PURPOSE: This randomized phase II trial is studying how well multimedia instruction of     caregivers in use of touch and massage works for cancer patients and their care partners.   "
213049|NCT00632411|"     Rates of cigarette smoking in the military are high. Tobacco telephone quit lines are     telephone-based services that provide information and guidance to people who want to quit     smoking. This study will evaluate the effectiveness of a tobacco quit line program, in     addition to nicotine replacement patches, at helping people in the military quit smoking     cigarettes.   "
213050|NCT00632424|"     This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21     days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and     safety of this dosing schedule in participants with advanced cancer   "
213051|NCT00632437|"     The goal of this proposal is to test the performance of a novel optical imaging system for     real-time quantitative imaging of brain function through multiple hemodynamic measures during     neurosurgery.      This pilot study encompasses two sub-aims:        -  Evaluate the ability of laser speckle contrast imaging to image cerebral blood flow          (CBF) intraoperatively. We will image the changes in CBF in response to somatosensory          stimulation. (5 patients).        -  Simultaneously image hemoglobin oxygenation, blood volume, blood flow, and cerebral          metabolic rate of oxygen (CMRO2) changes during somatosensory stimulation using a          combined laser speckle and multi-wavelength reflectance imaging system. (5 patients).   "
213052|NCT00632450|"     The EnSite Real-Time Cardiac Performance Measurements Study (EnSite RT CPM) is a multicenter,     international, acute, non-significant risk study, designed to enroll a maximum of 40 patient.     The goal of the study is to collect 3-D systolic/diastolic data with the EnSite NavX Mapping     system during a CRT implant.      Patients enrolled in this study will undergo NavX CPM recording of the heart using the EnSite     NavX Mapping system during the implantation of a cardiac resynchronization therapy device.   "
213053|NCT00638170|"     The objective of the study is to determine whether recurrences of urinary tract infection in     children can be prevented with cranberry juice.   "
213054|NCT00638183|"     Since Spiriva Inhalation Capsules 18mcg (hereinafter this product) are indicated for     treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic     bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey     is conducted to collect safety and effectiveness information on the use of this product for     long period of time in daily clinical settings, and to obtain proper drug use information.   "
213055|NCT00638196|"     Several investigations have suggested that polyunsaturated fatty acids may promote     therapeutic effects in MS. This pilot study will determine whether omega-6 polyunsaturated     fatty acids (PUFAs),in the form of linoleic acid,can reduce disease activity and prevent     disability progression in patients with relapsing MS.This study will seek to measure disease     activity as seen on MRI scans in addition to measuring relapse rates.   "
213056|NCT00638209|"     The purpose of the study is to investigate whether insulin sensitivity of the human brain     correlates with insulin sensitivity of the liver.   "
213057|NCT00638222|"     Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives   "
213058|NCT00638235|"     1. This is a prospective, multi-center, post market study, which will be conducted under a          common protocol.        2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic          Floor Repair System devices for prolapse repair.        3. The study population is female subjects > 21 years of age who require surgical          reconstruction of their pelvic floor due to prolapse.        4. The clinical data will be analyzed by comparing post-treatment data with the baseline          data, with the subject acting as her own control. The follow-up is for two years after          the procedure.        5. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary          endpoint of the study. The secondary endpoints include quality of life changes from          baseline and adverse event rates.   "
213059|NCT00638248|"     The purpose of this study was to explore trends in safety and efficacy, and to find the     optimal dose for the subsequent phase III trial. The decision to initiate the phase III trial     will depend on both safety (incidence of symptomatic intracranial hemorrhage) and efficacy     (reperfusion measured by MRI and correlating with clinical outcome) profiles. The safety     (incidence of symptomatic intracranial haemorrhage) and efficacy (reperfusion measured by MRI     and correlating with clinical outcome) profiles gained from this study were the basis of     planning the phase III.   "
213060|NCT00638261|"     Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been     approved for the treatment of moderate to severe psoriasis. However, in a portion of cases     adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or     greater, now being considered as gold standard for treatment efficacy. In this study we aim     to determine in a randomized half-side comparison whether initial narrowband UVB-311nm     phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated     patients.   "
213061|NCT00638274|"     The purpose of this study is to determine whether there is a difference in success outcome of     the combined spinal epidural labor analgesia between air versus saline when used to identify     the epidural space.   "
213062|NCT00638287|"     The purpose of this study is to demonstrate the degree of variability in commercially     available assays for Growth Hormone measurement in the context of clinical decision making     for Growth Hormone (GH) deficiency and Acromegaly and to determine variability among IGF-I     inter-assay samples obtained at the time of Growth-Hormone Releasing Hormone Arginine Testing     and Oral Glucose Tolerance Testing.   "
213063|NCT00638300|"     The study's hypothesis is that HD with large pore dialyzers remove to the dialysate iron     which is bound to potentially dialyzable ligands, after it's release from intravenous iron     compound administered during hemodialysis.   "
213064|NCT00638313|"     PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus.     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and     glucose lowering capabilities following a single subcutaneous dose.   "
213065|NCT00638326|"     The purpose of the study is to determine whether administration of 150 mg clopidogrel is     effective in reducing the one-year incidence of thromboischemic events in patients with high     on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous     coronary intervention.   "
213066|NCT00638339|"     The purpose of this study is to monitor sleep in patients using breathing machines, because     little is known about sleep when patients use masks to help their breathing. We'd like to     compare sleep in patients using masks to that in patients with a tube in their throats.   "
213083|NCT00640406|"     The clinical investigation is a prospective, international, multi-centre, randomized (1:1)     trial with follow ups at 2, 6, 12 months and 3 years.      The purpose of the study is to evaluate the clinical impact of percutaneous transluminal     renal artery stenting (PTRAS) on the impaired renal function measured by the estimated     Glomerular Filtration Rate (eGFR) in patients with hemodynamically significant     atherosclerotic renal artery stenosis (ARAS).   "
213067|NCT00638352|"     Needle biopsy is a way of determining whether a lung mass is cancerous or benign. Its     accuracy was established by research in which patients underwent fine needle aspiration, a     kind of needle biopsy that yields samples for cytology (similar to the way a pap smear or a     fluid sample would be evaluated for malignant cells). This kind of needle biopsy may     supplemented or replaced by core needle biopsy, which yields samples for histology (similar     to surgical tissue samples but on a smaller scale) rather than for cytology. Core needle     biopsy is believed to be helpful particularly in obtaining a diagnosis in patients who have a     lung mass that their doctors think is cancerous but is, in fact, benign. In spite of the     advances in needle biopsy, however, there are patients who do receive a pathology report     indicating no evidence of cancer but whose lung mass actually is cancerous. The fraction of     such patients, among all patients who have no evidence of cancer according to the biopsy, is     called the false negative rate. It is approximately 25% for needle biopsies that consist of     fine needle aspiration alone. The false negative rate for needle biopsies that include core     biopsy samples is not known.      We want to examine the accuracy of needle biopsy in patients who had core samples taken from     a lung mass in addition to, or in place of, fine needle aspiration. In this study we will     focus on such patients who had no evidence of cancer according to the biopsy, to determine     how many actually had a cancer that was missed by the biopsy. To accomplish this goal, we     will need to review the medical records of these patients for one of two things: either a     definitive diagnosis of the lung mass by some other means (for example, surgical biopsy), or     by seeing how the patient does over a period of time (usually in conjunction with medical     imaging tests such as chest x-rays or chest CT scans). To establish that a lung mass is     benign by observing a patient over time, it is necessary to show that the lung mass     disappears, becomes smaller, or remains unchanged in size for 2 years.   "
213068|NCT00638365|"     The primary objective of this study is to evaluate the safety and tolerability of a single     dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)   "
213069|NCT00638378|"     This is a clinical trial of orally administered Ruxolitinib (INCB018424) in patients whose     disease has progressed following 1 prior chemotherapy regimen (not including anti-androgens     or ketoconazole) for metastatic, androgen-independent prostate cancer.   "
213070|NCT00638391|"     The purpose of this study is the initial/followed by 5 year adjuvant therapy with     Anastrozole.   "
213071|NCT00638404|"     A simple preoperative evaluation assessing level of anxiety, anticipated pain, and intensity     rating of audio tone will predict the severity of postoperative pain after surgery.   "
213072|NCT00638417|"     The aim of the study is to improve hospital treatment and rehabilitation of patients with hip     arthroplasty to help the patients to regain functional ability in the shortest possible time,     and reduce hospital and rehabilitation time to save costs for the patient and society.      Optimal reconstruction of the hip joint and the effect of an intensive physical training     programme are compared to conventional rehabilitation programmes.   "
213073|NCT00638430|"     The purpose of this study is to examine the effect of the myopic optical defocus on the     Humphrey Matrix 30-2 test.   "
213074|NCT00638443|"     The primary objective of the proposed pilot study is to determine the efficacy of pregabalin     in prolonging the time to onset of pain and reducing the severity of pain associated with     walking in patients with neurogenic claudication. Neurogenic claudication is defined as     movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or     both legs provoked with walking and standing and relieved by sitting, squatting, or forward     flexion posturing. The secondary objective is to examine the functional benefit of pregabalin     with respect to improvement in duration and distance of walking.   "
213075|NCT00638456|"     This study is designed to evaluate whether or not oral viscous budesonide is effective in     treating children with Eosinophilic Esophagitis.   "
213076|NCT00638469|"     Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been     approved for the treatment of moderate to severe psoriasis. However, in a portion of cases     adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or     greater, now being considered as gold standard for treatment efficacy. In this study we aim     to determine in a randomized half-side comparison whether additional narrowband UVB-311nm     phototherapy accelerates and improves the clearance of psoriatic lesions in     adalimumab-treated patients after initial slow response.   "
213077|NCT00638482|"     Intrarenal calcifications (nephrocalcinosis) is present in Dent's disease and likely     contribute to progression toward renal failure. In order to prevent this complication it is     usually proposed to treat affected patients during childhood with high doses of thiazides.   "
213078|NCT00638495|"     The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable     pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this     drug or placebo for 28 days in four groups with a design of randomized, double-blind,     parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary     metabolites are to be determined.   "
213079|NCT00640354|"     Automated external defibrillators have improved survival for adult in hospital cardiac     arrest. Automated external defibrillators are approved for children aged 1 year and older for     out of hospital cardiac arrests. It is unknown whether automated external defibrillators have     a role for in hospital pediatric cardiac arrests.      The purpose of study is to compare the management of cardiac rhythm disorders by pediatric     residents using an automated external defibrillator versus a standard defibrillator in     simulated pediatric cardiac arrests.      It is our hypothesis that residents using an automated external defibrillator will have a     shorter time to defibrillation.   "
213080|NCT00640367|"     SYNTHESIS is a pragmatic multicenter randomized controlled trial (RCT), open-label, with     blinded follow-up aiming to determine whether loco-regional intra-arterial (IA) with     recombinant tissue-plasminogen activator (rt-PA) and/or mechanical devices, as compared with     systemic intravenous (I.V.) infusion of rt-PA within 3 hours of ischemic stroke, increases     the proportion of independent survivors at 3 months.   "
213081|NCT00640380|"     Cervical paravertebral blocks (CPVBs) target the brachial plexus from a puncture site     situated in the posterior aspect of the neck and represent an alternative to interscalene     blocks (ISBs) for shoulder and proximal humeral surgery. Randomized controlled trials     comparing CPVB and ISB have found no significant differences in success rate, onset and     offset times. Because of the reliability of their cutaneous landmarks, CPVBs have become part     of the investigators' standard practice. With this approach, the brachial approach can be     identified either with loss of resistance to air (LOR) or nerve stimulation (NS). While some     authors have used only LOR and reported good success rates, others have hypothesized that NS     may increase the reliability of the block. In the proposed study, for the first time, the 2     methods will be formally compared.   "
213082|NCT00640393|"     This study will provide data on the addition of narrow band ultra violet B (nbUVB)     phototherapy to participants who have not shown an excellent response to three months of     etanercept.   "
213086|NCT00640445|"     Veterans returning from combat deployments face the interrelated challenges of processing     their combat experiences and transitioning back to civilian life. Unfortunately, many     veterans wait years or decades before seeking help for post-deployment problems, if they seek     it at all. This study seeks to determine whether Internet-Based Expressive Writing (IB-EW), a     brief, low-cost, easily disseminated, and resource-efficient intervention, can reduce     psychological symptoms and improve functioning among Operation Iraqi Freedom (OIF) and     Operation Enduring Freedom (OEF) veterans as they navigate this transition, while also     attempting to reduce barriers to help-seeking. Expressive Writing, a highly private, readily     accessible, and non-stigmatizing intervention, has a strong evidence-base in civilian     populations, but its efficacy in combat veterans has not been tested. This study therefore     seeks to test the efficacy of Expressive Writing in a veteran population while further     enhancing its accessibility by delivering it over the internet (Internet-Based Expressive     Writing; IB-EW). This study will comprise a randomized controlled trial with three     conditions: (a) Internet-Based Expressive Writing, (b) Internet-Based Control Writing, and     (c) No Writing/Treatment As Usual, with a total of 1152 OIF/OEF veterans randomized across     these groups. Expressive Writing participants will write with feeling about their transition     from being a soldier to being a civilian; Control Writing participants will write factually     about the information needs of new veterans; and Treatment as Usual participants will     complete the assessments but not engage in any writing assignments. Participants will     complete standardized self-report measures of psychological symptoms, psychosocial     functioning, and life satisfaction at baseline (Session 1) and at three months (Session 6)     and six months (Session 7) post-intervention. Participants in writing conditions will write     for 20 minutes on four consecutive days (Sessions 2-5) following completion of baseline     measures (participants in the TAU condition will not complete Sessions 2-5). The study will     also attempt to identify individual difference characteristics related to the efficacy of the     treatment, to see who may be most likely to benefit from the treatment. Analyses will     primarily entail multivariate analyses of variance. Power is adequate to detect even a small     effect.   "
213087|NCT00640458|"     The purpose of this study is to investigate the effect of 100 mg sildenafil on clitoral     engorgement in pre-menopausal women, as well as examining the safety and toleration of the     drug.   "
213088|NCT00640471|"     RATIONALE: Brivanib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor. Monoclonal antibodies, such as     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances     to them. It is not yet known whether giving brivanib together with cetuximab is more     effective than cetuximab alone in treating patients with metastatic colorectal cancer.      PURPOSE: This randomized phase III trial is studying cetuximab to see how well it works     compared with cetuximab given together with brivanib in treating patients with metastatic     colorectal cancer.   "
213089|NCT00640484|"     The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be     given once a day to patients with COPD in order for the effect to last for 24 hours.   "
213090|NCT00640497|"     In this study, a combination of two T-cell directed antibodies both conjugated to a     cell-killing toxin will be evaluated. Previous in vitro studies have demonstrated that this     so-called immunotoxin-combination (IT-combination) acts synergistically in eliminating T     cells. In a subsequent clinical pilot-study, the IT-combination has generated encouraging     results when applied as third line therapy. Extensive biological and clinical responses could     be noted in the absence of severe acute toxicities. Building on this experience, the current     study aims at evaluating the characteristics of the IT-combination when administered in an     earlier phase of the disease, i.e. as second line instead of as third line therapy.   "
213091|NCT00640510|"     The primary objectives of the study is to confirm if the efficacy of IM olanzapine in     patients with schizophrenia is greater than IM placebo by comparing changes from baseline to     2 hours post first IM injection of agitation.   "
213092|NCT00640523|"     To evaluate the effectiveness and safety of forodesine in CLL patients   "
213093|NCT00640536|"     The purpose of this study is to determine the structural and functional cardiac alterations     in obstructive sleep apne (OSA) independent from systemic and pulmonary arterial hypertension     and their correlation to the severity of OSA.   "
213094|NCT00640549|"     The study will investigate the effects of atorvastatin on the concentrations of small, dense     LDL and HDL subfractions in patients with diabetes and the underlying mechanisms of these     effects.   "
213095|NCT00640562|"     Aim of the study is to assess if the new compound Seroquel XR™ is non-inferior to     Risperidone, considered as the reference drug for the treatment of depressive symptoms of     schizophrenia.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
213096|NCT00640575|"     Corticosteroid injections is a popular treatment option in shoulder disease. The evidence of     effectiveness of corticosteroid injections is however contradicting. The importance of the     accuracy of the steroid placement have been discussed and recently there are a few studies     indicating better treatment effect if the injections are guided towards specific anatomical     structures by real time ultrasound imaging. None of these studies have been double blinded.     The aim of this study is to investigate the importance of placement of steroid injection in     patients with rotator cuff disease by comparing systemic and ultrasound-guided injection in     the subacromial bursa using a double blinded design.   "
213097|NCT00640588|"     This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment     with telbivudine   "
213098|NCT00640601|"     A Multicentre, Open-label, Prospective Long-term Study Evaluating the Clinical Benefit and     Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in Subjects with     Schizophrenia.   "
213099|NCT00640614|"     We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic     performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate,     Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse     blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients     with suspected contact dermatitis, and in adult patients with a known or suspected     sensitization to at least one of the seven allergens.   "
213100|NCT00640627|"     To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients     with knee osteoarthritis who were unresponsive to treatment with prescription strength     naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen   "
213125|NCT00640952|"     The purpose of this study is to determine how many patients with Parkinson's disease have     compulsive behaviors, and what types of behaviors they have. This study will also determine     if acamprosate can be used to treat compulsive behaviors in Parkinson's disease patients.   "
213203|NCT00641992|"     Amebic liver abscess is the most frequent extra-intestinal form of the amoebiasis; actually     the factors for predicting failure in the medical treatment are not clear. We conducted trial     for determining the clinical value of paraclinical factor in this issue.   "
213101|NCT00640640|"     One concern about repeated intravitreal injections of bevacizumab (Avastin) and ranibizumab     (Lucentis) in wet age related macular degeneration, is that in addition to blocking the     proteins that triggers the development and proliferation of abnormal vessels in the center of     the retina, they may also result in changes in the normal vessels that feeds the outer part     of the retina.      Small vessels with fenestrations (such as those that feed the outer part of the retina, which     are called choriocapillaris) appear to be especially sensitive to this protein (called     vascular endothelial growth factor, VEGF) withdrawal.      It is estimated that global blood flow in the vascular layer under the retina (called     choroid) may be indirectly assessed by measuring the amplitude of the ocular pulsation (the     pressure inside the eye change according to the cardiac cycle, similar to the change in blood     pressure) which is called Ocular Pulse Amplitude (OPA). The Pascal Dynamic Contour Tonometer     (Pascal DCT) is a new tonometer (a device which measures the pressure within the eye)     designed to measure intraocular pressure and ocular pulse amplitude.      No published study has yet assessed the effect of bevacizumab (Avastin) or ranibizumab     (Lucentis) treatment for wet AMD (or on any other retinal disease) on OPA. This is our aim in     this pilot study, in which we will measure the pressure within the eye just prior to     bevacizumab/Ranibizumab treatment, followed by repeated measurements a week and a month after     the treatment.      For this purpose, up to 60 patients with wet AMD will be recruited.   "
213102|NCT00640653|"     This study will develop and evaluate the effectiveness of culturally appropriate HIV/sexually     transmitted disease risk-reduction interventions in reducing sexual risk behavior among young     African-American adolescents.   "
213103|NCT00640666|"     It is important to confirm health benefits experienced by breast cancer survivors after     participation in a physical activity behavior change intervention. One such potential benefit     is a reduction in harmful inflammation that might lead to increased symptoms or cancer risk.     Because little is known about how physical activity behavior change interventions influence     inflammation in breast cancer survivors, the investigators study will measure inflammation     with blood markers known as cytokines among breast cancer survivors before and after a     physical activity intervention. Such information has the potential to lead to improved     physical functioning, reduction in bothersome symptoms (e.g., fatigue), and reduced cancer     risk in breast cancer survivors.   "
213105|NCT00640692|"     The purpose of this study is to determine the genetic makeup of gastro intestinal stomach     tumors (GISTs) from patients enrolled in the A6181112 phase IIIb trial. Tumor samples will be     screened for mutations and this information will be used to determine whether the     progression-free survival of patients being treated with the cancer medication sunitinib is     related to the underlying genotype of their GIST.   "
213106|NCT00640705|"     The primary purpose of this study is to assess the effectiveness of once daily application of     a diclofenac sodium patch to the skin near or over the painful area. In this study, the     location being studied will be either the left or right ankle.      The secondary purpose of this study is to assess the safety and tolerability of a diclofenac     patch on the skin.   "
213107|NCT00640718|"     The EverOn™ system developed by EarlySense, Ltd., the sponsor of this study, is intended to     assist hospitals to better address and improve recognition and response to changes in a     patient's condition.      The system, monitors the patient while in bed consists of a contact-free sensor that is     placed under the bed mattress and identifies respiratory and heart rates, degree of patient's     movement or agitation while in bed as well as patient's actual exit out of the bed. The     EverOn system does not require a physical contact with the patient, eliminating the need for     any direct contact electrodes, leads, cuffs or nasal cannulae.   "
213108|NCT00640731|"     This is a prospective, multi-center single arm registry to assess the use of the OmniWave     Endovascular System in subjects presenting with either lower or upper extremity acute     (symptoms have been present for greater than or equal to 14 days) DVT.   "
213109|NCT00640744|"     Atherosclerosis is a disease in which the blood vessels become blocked by plaques (consisting     of fat, calcification, and fibrous tissue), reducing blood flow to vital organs and     tissues.Blockage of the carotid arteries in the neck is a major cause of stroke. One way of     treating carotid atherosclerosis is with cholesterol-lowering drugs called statins. Statins     have been shown to reduce the risk of coronary heart disease by 24-40% and risk pf stroke by     11-30%.The purpose of this study is to determine if short term treatment with atorvastatin     causes early favorable changes in the plaques that block blood flow through the carotid     arteries. These changes can be assessed 1) by taking pictures of the carotid arteries with     MRI and Ultrasound before and after statin treatment, and 2) by special studies of the     plaques removed from the carotid arteries by surgery.   "
213110|NCT00640757|"     The purpose of this study is to determine if limiting dietary methionine (MET), one of the 10     essential amino acids (which make up proteins), causes weight loss and/or improves glucose     metabolism.   "
213111|NCT00640770|"     The primary objective of this study is to compare the performance of the CYPHER SELECTTM +     Sirolimus-eluting Balloon-expandable Coronary and Infrapopliteal Stent over balloon     angioplasty in de novo and restenotic native below the knee tibioperoneal, anterior and/or     posterior tibial and/or peroneal arterial lesions in a prospective, multicenter, randomized     clinical study.   "
213126|NCT00640965|"     The study will evaluate if DP-VPA, a derivative of valproate (a drug that is commonly used     for the prevention of migraine attacks), can reduce the rate of migraine attacks.      Migraine patients will take DP-VPA or placebo (an inactive look-alike drug) every morning and     will have to report any migraine attacks they have during the study's 18-week follow up.   "
213127|NCT00640978|"     The goal of this clinical research study is to learn if the combination of RAD001 and     erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this     drug combination will also be studied.      Primary Objectives:      -Determine the overall survival (OS) at 6 months of the combination of erlotinib and RAD001     in patients who have received previous treatment for advanced pancreatic cancer.      Secondary Objectives:        -  Determine the progression-free survival (PFS).        -  Determine the response rate (RR).   "
213128|NCT00640991|"     Insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial     infarction and admission hyperglycemia.   "
213112|NCT00640783|"     The metabolic syndrome has been identified as a target for dietary therapies to reduce risk     of cardiovascular disease; however, the role of diet in the etiology of the metabolic     syndrome is poorly understood. To assess the effect of a Mediterranean-style diet on     endothelial function and vascular inflammatory markers in patients with the metabolic     syndrome      Randomized, single-blind trial conducted from June 2001 to January 2004 at a university     hospital in Italy among 180 patients (99 men and 81 women) with the metabolic syndrome, as     defined by the Adult Treatment Panel III.      Patients in the intervention group (n = 90) were instructed to follow a Mediterranean-style     diet and received detailed advice about how to increase daily consumption of whole grains,     fruits, vegetables, nuts, and olive oil; patients in the control group (n = 90) followed a     prudent diet (carbohydrates, 50%-60%; proteins, 15%-20%; total fat, <30%).      After 2 years, patients following the Mediterranean-style diet consumed more foods rich in     monounsaturated fat, polyunsaturated fat, and fiber and had a lower ratio of omega-6 to     omega-3 fatty acids. Total fruit, vegetable, and nuts intake (274 g/d), whole grain intake     (103 g/d), and olive oil consumption (8 g/d) were also significantly higher in the     intervention group (P<.001). The level of physical activity increased in both groups by     approximately 60%, without difference between groups. Mean body weight decreased more in     patients in the intervention group (-4.0 kg) than in those in the control group (-1.2 kg)     (P<.001). Compared with patients consuming the control diet, patients consuming the     intervention diet had significantly reduced serum concentrations of hs-CRP (P = .01), IL-6 (P     = .04), IL-7 (P = 0.4), and IL-18 (P = 0.3), as well as decreased insulin resistance     (P<.001). Endothelial function score improved in the intervention group but remained stable     in the control group. At 2 years of follow-up, 40 patients in the intervention group still     had features of the metabolic syndrome, compared with 78 patients in the control group     (P<.001).      A Mediterranean-style diet might be effective in reducing the prevalence of the metabolic     syndrome and its associated cardiovascular risk.   "
213113|NCT00640796|"     Modern frontline therapy for patients with hematologic malignancies is based on intensive     administration of multiple drugs. In patients with relapsed disease, response to the same     drugs is generally poor, and dosages cannot be further increased without unacceptable     toxicities. For most patients, particularly those who relapse while still receiving frontline     therapy, the only therapeutic option is hematopoietic stem cell transplantation (SCT). For     those who relapse after transplant, or who are not eligible for transplant because of     persistent disease, there is no proven curative therapy.      There is mounting evidence that NK cells have powerful anti-leukemia activity. In patients     undergoing allogeneic SCT, several studies have demonstrated NK-mediated anti-leukemic     activity. NK cell infusions in patients with primary refractory or multiple-relapsed leukemia     have been shown to be well tolerated and void of graft-versus-host disease (GVHD) effects.     Myeloid leukemias are particularly sensitive to NK cells cytotoxicity, while B-lineage acute     lymphoblastic leukemia (ALL) cells are often NK-resistant. We have developed a novel method     to expand NK cells and enhance their cytotoxicity. Expanded and activated donor NK cells have     shown powerful anti-leukemic activity against acute myeloid leukemia (AML) cells and     T-lineage ALL cells in vitro and in animal models of leukemia.      The present study represents the translation of these laboratory findings into clinical     application.We propose to determine the safety of infusing expanded NK cells in pediatric     patients who have chemotherapy refractory or relapse hematologic malignancies including AML,     T-lineage ALL, T-cell lymphoblastic lymphoma (T-LL), chronic myelogenous leukemia (CML),     juvenile myelomonocytic leukemia (JMML),myelodysplastic syndrome (MDS), Ewing sarcoma family     of tumors (ESFT) and rhabdomyosarcoma (RMS). The NK cells used for this study will be     obtained from the patient's family member who will be a partial match to the patient's immune     type (HLA type).   "
213115|NCT00640822|"     There are few therapies suitable for the treatment of psoriasis on the face and skin folds.     As these areas are sensitive, irritation and other adverse reactions are more common than     elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once     daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus     hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in     patients with psoriasis vulgaris on the face and on the intertriginous ares   "
213116|NCT00640835|"     This study will evaluate the safety and tolerability on the oral mucosa of     buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12     weeks in opioid dependent individuals who are already on a stable regimen of     buprenorphine/naloxone.   "
213117|NCT00640848|"     The aim of the study is to determine the minimum effective dose of ACT-078573 on sleep     efficiency and to assess the effects of different doses of ACT-078573 on other PSG     parameters.   "
213118|NCT00640861|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells. It is not yet known which vaccine is most effective in treating breast     cancer.      PURPOSE: This randomized clinical trial is studying the side effects of three different     vaccine therapies and comparing the vaccines to see how well they work in treating patients     with previously treated stage II or stage III breast cancer.   "
213119|NCT00640874|"     This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as     short-term prophylaxis against pandemic influenza infection in people who have close familial     contact with the disease. The study is observational only. The primary measure used in this     study will be the incidence of symptomatic pandemic influenza in patients receiving     prophylaxis. Seroconversion to pandemic influenza, the incidence of adverse events and the     relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. This     project will commence upon pandemic influenza being declared in Australia, Hong Kong or     Singapore. Data will be analysed as quickly as possible to help inform the continued use of     neuraminidase inhibitor therapy as a cornerstone of the public health agency response to     pandemic influenza.   "
213120|NCT00640887|"     The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin     (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an     alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic     induction effect appears to be less important on the associated antiretroviral therapy (ART)     drugs.      This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in     combination with different ART regimens in Vietnamese HIV infected patients with pulmonary     tuberculosis, in order to define optimal doses that will be further tested in a larger phase     III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.   "
213121|NCT00640900|"     This study will provide data on the response over 24 months to two commercial weight loss     programs (center-based and telephone-based) compared to control conditions.   "
213122|NCT00640913|"     In this trial will be investigated if a defunctioning loop stoma used in low anterior     resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which     is present clinical practise.   "
213123|NCT00640926|"     The purpose of this study is to determine whether RX-1741, an oxazolidinone antibiotic, is     safe and effective in the treatment of mild to moderate community acquired pneumonia (CAP).   "
213124|NCT00640939|"     The primary purpose of this study is to assess the effectiveness of once daily application of     a diclofenac sodium patch to the skin near or over the painful area. In this study, the     location being studied will be one of the following: the affected shoulder, elbow, or wrist.      The secondary purpose of this study is to assess the safety and tolerability of the     diclofenac patch on the subject's skin, in the location being studied.   "
213129|NCT00641004|"     Primary objective: To determine the levels of malondialdehyde (MDA) and immunohistochemistry     surrogate of inflammation in patients with NSAID-induced gastric mucosal injury treated with     Rebamipide 3x a day vs Esomeprazole 40mg once a day. Secondary objective: For patients who     become symptomatic during NSAID treatment, to compare the proportion of patients with     positive treatment effects using the Likert scale. Third objective: To compare the proportion     of patients with positive treatment effects as determined by Modified Lanza scoring between     the two groups.   "
213130|NCT00641017|"     Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections     in children, the elderly, and those with compromised immune systems. HPIV1 is also the     leading cause of viral croup in children under 6 years old. The purpose of this study is to     determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 2     groups of adults and then in children who have been previously exposed to HPIV1. Once the     safety of this vaccine has been established in these groups, an additional 2 groups of     infants and children who have not been previously exposed to HPIV1 will be vaccinated. Naïve     infants and children are the most vulnerable to naturally circulating HPIV1 and are the     target population of this vaccine.   "
213131|NCT00641030|"     RATIONALE: Giving chemotherapy, such as clofarabine and melphalan, before a donor stem cell     transplant helps stop the growth of cancer or abnormal cells. It also helps stop the     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells     from a donor are infused into the patient, they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells     from a donor can make an immune response against the body's normal cells. Giving cyclosporine     and mycophenolate mofetil after the transplant may stop this from happening.      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when     given together with high-dose melphalan followed by a donor stem cell transplant in treating     patients with acute myeloid leukemia, acute lymphocytic leukemia, or myelodysplastic     syndromes.   "
213132|NCT00641043|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial     combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with     insufficient glycaemic control.   "
213133|NCT00641056|"     The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and     insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen     et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and     tolerability.   "
213136|NCT00641095|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. It is not yet known     whether giving combination chemotherapy together with rituximab is more effective than     combination chemotherapy alone in treating mantle cell lymphoma.      PURPOSE: This randomized phase III trial is comparing how well fludarabine and     cyclophosphamide work when given together with or without rituximab in treating patients with     previously untreated mantle cell lymphoma.   "
213137|NCT00641108|"     This study will examine changes in brain serotonin activity in people with depression before     and after they receive cognitive behavioral therapy.   "
213138|NCT00641121|"     Unexplained fever in children with cancer is a common occurrence, often requiring hospital     admission for evaluation and treatment with intravenous antibiotics. While empiric use of     intravenous antibiotics is the norm in this population, between 48-70% of febrile and     neutropenic episodes remain without an identifiable source. An understudied area is the     potential role of betaherpesvirus infections in such febrile episodes. These viruses are     significant pathogens in patients who become immunocompromised in conjunction with organ     transplantation or acquired immune deficiency syndrome (AIDS). It is possible that they are     similarly pathogenic in children who become immunocompromised due to cancer chemotherapy.      Thus, we will investigate the association between the betaherpesviruses and fever in children     with cancer. The betaherpesviruses include cytomegalovirus (CMV), human herpesvirus 6A     (HHV-6A), human herpesvirus 6B (HHV-6B), and human herpesvirus 7 (HHV-7). These viruses are     grouped based on shared biological and genetic properties. Each is commonly acquired in     childhood, persists in the human host, and can reactivate. Reactivation occurs intermittently     throughout life in healthy individuals and is seldom associated with disease. Immune     suppression is associated with a higher likelihood of reactivation and clinical disease.     Latency of these viruses involves highly regulated processes that result in the viruses     evading destruction and persisting within the host. Should balance be disrupted, as with     cancer and anticancer therapy altering the normal host state, the environment may become     favorable for betaherpesvirus reactivation, leading to disease and further alterations of the     immune system.   "
213139|NCT00641134|"     The goal of this trial is to assess the medium- (6 months) and long-term (12 months) effects     of a Home-Based exercise program after in-Hospital comprehensive Cardiac Rehabilitation (CR)     - as compared with usual care - on exercise capacity, health-related quality of life and     health care services utilization, in patients (pts) older than 75 years after recent acute     coronary syndromes or cardiac surgery.   "
213140|NCT00641147|"     This randomized phase II trial studies curcumin in treating patients with familial     adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of     rectal polyps or colorectal neoplasia.   "
213141|NCT00641160|"     The purpose of this study is to determine the safety of oral administration of vinorelbine     once daily for at least 7 days. The study will be conducted in subjects with a     non-hematologic malignancy for which there are no currently accepted therapies.   "
213142|NCT00641173|"     Over 150,000 soldiers are currently deployed in Iraq as part of Operation Iraqi Freedom     (OIF), and 12% of returning OIF veterans have posttraumatic stress disorder (PTSD).     Intervening soon after the trauma is critical for long-term outcomes, since with time     traumatic memories become resistant to treatment. The current study will compare treatment     with the selective serotonin reuptake inhibitor (SSRI) paroxetine to placebo in returning OIF     veterans who have returned from Iraq in the past six months, who meet criteria for early     PTSD. Assessment of PTSD symptoms, brain markers, neuropsychological testing of memory, and     cortisol response to an Iraq-related traumatic script before and after the intervention are     proposed to provide information about the effects of the interventions on PTSD symptoms and     stress-responsive hormonal systems.   "
213143|NCT00641186|"     This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for     the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in     patients with mild to moderate Parkinson's Disease (PD).   "
213144|NCT00641199|"     The purpose of this study is to evaluate if ingestion of a probiotic formula (Jarrow-Dophilus     EPS)reduces incidence of diarrhea and improves the quality of life of patients receiving     antibiotic therapy.   "
213145|NCT00641212|"     The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on     growth in children with perennial allergic rhinitis over 12 months.   "
213146|NCT00641225|"     The purpose of this study is to determine the safety and tolerability of single doses of     SBI-087 in subjects with rheumatoid arthritis.   "
213147|NCT00641238|"     We are collecting clinical notes and results of imaging studies (CT and PET scans) from     referring physicians who follow the clinical status of patients treated with radiofrequency     ablation (RFA). The research objective is to determine whether the patients with (RFA) remain     alive, and whether they are in remission or have progressive/ recurrent malignancy   "
213148|NCT00641251|"     The present study is the first stage of a research program whose ultimate goal is to conduct     a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2. This     program will determine the relative effectiveness of RYGB combined with intensive medical     management (IMM), versus IMM alone, in reducing CVD event rates and mortality in patients     with poorly controlled diabetes. IMM will include rigorous lifestyle modification for weight     loss and stepped pharmacologic treatment for diabetes and other CVD risk factors. The     proposed study is a randomized trial which will provide an assessment of the efficacy of     treatment, in reducing CVD risk factors and also assessing the feasibility, cost, and safety     of a larger trial.   "
213149|NCT00641264|"     The primary purpose of this study was to establish the psychometric properties of a new     disease specific Quality of Life questionnaire, the LPR-HRQL. The specific properties of the     questionnaire that were evaluated were: validity, reliability, and responsiveness to change     (as a measure of treatment effect).   "
213690|NCT00650481|"     The objective of this study was to investigate the single-dose relative bioavailability of     Mylan's oxybutynin chloride Extended-release tablets to ALZA's Ditropan XL® tablets following     a single, oral 20 mg (4 x 5 mg) dose under fasting conditions.   "
213150|NCT00641277|"     Dental implants are used in dentistry to reestablish function and appearance to areas of the     mouth where natural teeth are missing. Implants can be a good choice for almost all areas of     the mouth except where the space left by missing teeth is too narrow. This is usually the     case when front teeth are lost of have been missing since birth.      The Maximus dental implant is the smallest implant made, just 3mm in diameter, and is     especially designed to replace missing front teeth and yet be strong enough to function as a     natural tooth.      This study will assess the functional success of BioHorizons Maximus one-piece endosseous     dental implant.      We hypothesize that placement of the 3mm dental implant in areas of limited tooth-to-tooth     spacing will be an efficacious tooth root replacement.   "
213151|NCT00641290|"     To study the role of Vigileo monitor using the FloTrac sensor to measure cardiac output using     the pulse contour analysis as well as central venous oxygen saturation monitoring as a guide     for tissue perfusion. The accuracy of the Vigileo monitoring was compared with the     conventional thermodilution method for measuring cardiac output using the pulmonary artery     catheter and mixed venous oxygen saturation for assessing global tissue perfusion.   "
213152|NCT00641303|"     RATIONALE: Acupuncture may help relieve muscle and bone pain caused by aromatase inhibitor     therapy, such as letrozole, exemestane, and anastrozole.      PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works in     reducing muscle and bone symptoms in women receiving letrozole, exemestane, or anastrozole     for stage 0, stage I, stage II, or stage III breast cancer.   "
213153|NCT00641316|"     When a tooth is extracted the ridge of bone that held the tooth in place begins to heal and     over time new bone grows to fill the empty space left by the missing tooth. Sometimes this     process works very well and new bone grows to completely fill the socket, at other times new     bone fails to fill in the space completely and patients are left with uneven bone-fill.      Grafted extraction sockets may fill with bone faster and more evenly than those without     grafts, allowing the dentist to have greater control over the healing process and to repair     the area with dental implants in a shorter period of time.      This study will help determine if grafting an extraction socket, with or without enriching     the graft material, is an added benefit when compared to allowing the socket to heal     naturally.      The study will also assess how well two different dental implant designs used to restore the     area will function over time.   "
213154|NCT00641329|"     The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a     safe and effective add-on to psychostimulant therapy in children and adolescents with     attention deficit hyperactivity disorder (ADHD).   "
213155|NCT00641342|"     Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around     the stoma. In some cases these problems result in the need of surgical correction and the     risk of recurrent hernia after operative intervention is regrettably high. Preliminary     investigations suggest a role for primary mesh placement to prevent parastomal hernia. The     use of a mesh as a preventive measure is a safe procedure. This study will focus on the     effect of primary mesh placement (two different operative procedures are used) compared to     patients without mesh placement.   "
213156|NCT00641355|"     Monitoring of different serumproteins after severe trauma and during trauma-induced sepsis.        -  Trial with surgical intervention   "
213157|NCT00641368|"     The study will evaluate the R4Power program, an online intervention designed to teach     adolescents coping and problem-solving skills.   "
213158|NCT00641381|"     RATIONALE: Giving high-dose chemotherapy drugs, such as carmustine, etoposide, and     cyclophosphamide, before a peripheral blood stem cell transplant stops the growth of cancer     cells by stopping them from dividing or killing them. After treatment, stem cells that were     collected from the patient's blood are returned to the patient to replace the blood-forming     cells that were destroyed by the chemotherapy.      PURPOSE: This clinical trial is studying the side effects of giving high-dose carmustine,     etoposide, and cyclophosphamide together with a stem cell transplant and to see how well it     works in treating patients with HIV-associated lymphoma.   "
213159|NCT00641394|"     The purpose of this study is to determine whether there is a change in levels of cortisol, a     key stress hormone, during the course of a psychotherapy session. The two forms of     psychotherapy compared are Cognitive Behavioral Therapy (CBT) and Emotional Freedom     Techniques (EFT). A no treatment control group provides a baseline measure. The change in     cortisol level is compared between the start and end of a one hour session.   "
213160|NCT00641407|"     The maintenance of nearly normal glycemic levels reduces the risk of diabetic complications,     but is difficult to achieve, despite the administration of escalating doses of oral     antidiabetic drugs, such as metformin, sulfonylureas, and thiazolidinediones. Most patients     eventually require insulin which usually is added when glycemic control with a regimen of     oral antidiabetic agents becomes suboptimal.      The aims of the present study were: 1) To compare the clinical efficacy of insulin glargine     and neutral protamine lispro (NPL) insulin when added to ongoing oral therapy in poorly     controlled type 2 diabetic patients; 2) to find out the possibility to phenotype the patient     who may benefit more by the single treatment.      This an open-label, randomized, parallel, 36-week comparative study was performed between     January 2007 and March 2008 at a single centre.   "
213161|NCT00641420|"     Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair     skinned individuals. This study aims to test the efficacy and safety in darker skin types.     Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five     treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%,     50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.   "
213162|NCT00641433|"     This study's purpose is to prospectively determine whether topical therapy with an oxidized     regenerated cellulose collagen-silver compound is more effective than the current standard of     topical antibiotic therapy for care following the removal of an ingrown toenail. Eighty adult     patients with ingrown toenails will be recruited. Each patient will randomly be assigned to     apply either topical silver sulfadiazine cream (standard antibiotic) or the novel     collagen-silver compound to their nail bed daily, following removal of the ingrown portion of     nail. Patients will return for follow up visits weekly, until healing has occurred or twelve     weeks have passed. Healing will be defined as resolution of drainage and inflammatory changes     surrounding the nail border.   "
213164|NCT00641459|"     The purpose of this observational study is to obtain the current status of patients with     Behavioral and Psychological Symptoms of Dementia. This study is also expected to further     provide insight into the evolution of behavioral and psychotic symptoms and its relationship     with treatment as well as severity of cognitive declines in a naturalistic setting.   "
213165|NCT00641472|"     A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given     once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the     evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children     aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will     receive 5mg strength SINGULAR.   "
213166|NCT00641498|"     Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our     objective is to evaluate the addition of the resources of an suicide prevention centre to     standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt     patients in 2 Emergency departments (multicenter study) were included after standard     psychiatric treatment and referral. After Written informed consent, psychological assessment     (depression, suicide intention) was carried out After randomisation, control patients were     given an information card describing the Suicide Prevention Center (SPC); experimental     patients had a first meeting with a psychologist of the SPC.      To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an     evaluation of these behaviors was carried out every month during a two year follow-up.   "
213167|NCT00641511|"     Assess the effect of nepicastat in the treatment of in Post Traumatic Stress Disorder (PTSD)     in conflict or combat zone experienced veterans, in comparison to placebo.   "
213168|NCT00641524|"     The purpose of this study is to evaluate the use of phlebotomy (blood taking)as a treatment     for patients with non-alcoholic fatty liver disease.   "
213169|NCT00641537|"     The purpose of this extension trial is to further evaluate the safety and tolerability of     oral cladribine in subjects who have previously completed treatment within Trial 25643     (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week     treatment.   "
213170|NCT00641550|"     The effects of physical exercise on pregnancy remain to be elucidated. A randomized     controlled trial will be conducted to study the impact of exercise on maternal and perinatal     outcomes. Our hypothesis is that physical exercise reduces preeclampsia incidence and     improves birthweight when started early in pregnancy, with no impact on pregnancy duration,     Apgar scores and neonatal complications.   "
213188|NCT00641784|"     In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine     versus intravenous magnesium sulfate in the acute management of preterm labor in terms of     defined early and late neonatal measures   "
213199|NCT00641927|"     This study examines the relative safety and benefit of antidepressant therapy (versus     recommended mood stabilizer therapy)of bipolar type II major depressive episode. We     hypothesize that antidepressant therapy will be superior to mood stabilizer therapy with     little or no difference in treatment emergent manic symptoms.   "
213200|NCT00641940|"     This is a pilot study of the Girls in Transition (GT) program, an intervention designed to     promote resilience and reduce gender-related risk factors for depression. The goal of the     study is to gather preliminary data on the effects of the GT program.   "
213171|NCT00641563|"     Sedation may be necessary in intensive care to facilitate diverse therapeutic interventions,     but the use of sedative drugs may increase the risk of delirium and long-term cognitive     impairment. Thus the implementation and monitoring of sedation remains difficult despite the     use of sedation protocols and clinical sedation scores. Attempts to improve sedation     monitoring through the use of the electroencephalogram(EEG) have been disappointing. Derived     variables based on the unstimulated EEG fail to predict the response to external stimuli at     the clinically most relevant light-to-moderate sedation levels, and the overlap between     moderate and deep sedation levels is wide. We have demonstrated that long-latency auditory     evoked potentials (ERPs)can be used to avoid deep levels of sedation in healthy volunteers     during propofol sedation, independent of the concomitant administration of remifentanil. This     approach has a potential clinical application for improved monitoring of sedation. Since the     effects of different sedative drugs on the EEG may vary widely, the use of ERPs to monitor     sedation needs to be evaluated with different sedative drugs. Therefore we will administer     two widely used drug combinations (dexmedetomidine/remifentanil and midazolam/remifentanil)     in healthy volunteers and record ERPS and processed EEG during clinical relevant sedation     levels   "
213172|NCT00641576|"     Dental implants are small metal posts that look like miniature screws. They are surgically     implanted into the jawbone where they serve as substitute tooth roots. Implants are used in     dentistry to reestablish function and aesthetics to areas of the mouth were natural teeth are     missing.      Classical dental implants are made in two pieces. One part anchors in the jawbone and one     part serves as a connecting post (an abutment) that attaches to a crown restoration or to     attachment clasps that hold a denture in place.      Occasionally the materials used to fasten the two implant components together work their way     loose and over time the abutment may begin to disconnect. If this happens a small gap appears     between the implant and abutment. There are many reasons why this loosening occurs. One     reason may be the design of the implant itself and another may be the way the two components     are fastened together.      This study will assess the performance of an implant with a new design. The investigators     hypothesize that using this implant design will reduce the risk of an implant-abutment     disconnect and improve long-term success of implant therapy.   "
213173|NCT00641589|"     The primary objective of this study is to describe how four different dosing regimens of     PROCRIT (epoetin alfa) are utilized in patients with anemia due to non-dialysis chronic     kidney disease (CKD).   "
213174|NCT00641602|"     This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated     with either esomeprazole or lansoprazole   "
213175|NCT00641615|"     The purpose of this study is to evaluate the safety and immune response of different doses of     RNF43-721 emulsified with Montanide ISA 51 in combination with S-1/CPT-11 chemotherapy.   "
213176|NCT00641628|"     96 patients were offered a nipple sparing mastectomy.   "
215282|NCT00668135|"     To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456)     compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)   "
213178|NCT00641654|"     To evaluate the efficacy of pegylated interferon alfa-2a 40 kD (PEGASYS) combination therapy     with ribavirin (Copegus)given for 24 or 48 weeks in patients with chronic hepatitis C (CHC)     virus infection genotype 2 or 3 who responded during (i.e. had HCV-RNA <50 IU/mL at the end     of previous therapy), but relapsed after (i.e. had detectable HCV-RNA after the end of prior     treatment) previous therapy with pegylated interferon and ribavirin given for at least 12     weeks and at most 24 weeks.   "
213179|NCT00641667|"     The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day     transdermal patch (patch containing a drug that is put on the skin so the drug will enter the     body through the skin) in participants switched from morphine preparations, oral oxycodone     preparations, fentanyl citrate injection or fentanyl patch for cancer pain.   "
213180|NCT00641680|"     The purpose of this study is to compare once daily treatment with Rhinocort against placebo     and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.   "
213181|NCT00641693|"     The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5     years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and     stuffy noses.   "
213182|NCT00641706|"     This phase II trial is studying how well giving vorinostat together with bortezomib works in     treating patients with progressive, recurrent glioblastoma multiforme. Vorinostat and     bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving vorinostat together with bortezomib may kill more tumor cells.   "
213183|NCT00641719|"     The purpose of the study is to investigate safety and efficacy of duloxetine for patients     with painful diabetic neuropathy at long-term use.   "
213184|NCT00641732|"     The purpose of this study is to determine if TAK-442, once daily (QD) or twice daily (BID),     is as safe and effective as enoxaparin in preventing the development of blood clots after     knee replacement surgery.   "
213185|NCT00641745|"     Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This     clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long     term among clinically stable patients. The study will also assess the long term effectiveness     of lurasidone as compared to an active comparator.   "
213186|NCT00641758|"     Pycnogenol® is a proprietary bark extract of the French maritime pine tree (Pinus pinaster     ssp. atlantica). Pycnogenol® has prevented pathologic symptoms such as chronic inflammation     and increased platelet aggregation, a risk factor for cardiovascular diseases. The     endothelium is increasingly recognized not only a target (with vascular remodelling occurring     in response to an injury and resulting in atherosclerosis), but also a mediator in the     pathogenesis of atherosclerosis. Indeed, endothelial cells play an important regulatory role     in the cardiovascular system by the expression of numerous molecules and release of mediators     such as nitric oxide (NO), superoxide and endothelin-1 (ET-1). Data from animal studies, as     well as human studies indicate that Pycnogenol may improve endothelial function, which is a     powerful surrogate for clinical prognosis.   "
213187|NCT00641771|"     To compare change in fractional calcium absorption following administration of MK0217A     relative to matching placebo, in postmenopausal women with osteoporosis   "
213189|NCT00641797|"     Benign Paroxysmal Positional Vertigo (BPPV) is a common complaint of emergency department     patients. The importance of early diagnosis and treatment can lead to a much improved quality     of life for patients afflicted by this ailment. It is the purpose of this study to evaluate     and examine two methods of treatment. Patients will be randomized to receive the more common     conventional medication therapy versus the canalith repositioning technique. All patients     enrolled into this study are emergency department patients who have been diagnosed with BPPV     via a positive Dix-Hallpike Maneuver. The hypothesis of this study is that vestibular     rehabilitation will allow for resolution of symptoms without the use of conventional     medication therapy in the acute management of BPPV in the emergency department patient.   "
213190|NCT00641810|"     Snoring is a problem for many people, often disturbing energy level, quality of sleep, and     the relationship with a bed partner. Two observational studies that have indicated a     relationship between the consumption of caffeine and snoring. The objective of this study     will be to observe the degree of snoring and quality of sleep when caffeine intake is reduced     over a period of four weeks. This will be a prospective, before-and-after study of a     behavioral intervention.      This study will engage thirty adults who report snoring, drink two cups of coffee or more per     day (or an equivalent amount of caffeine), and have a consistent bed partner who can report     on snoring severity. Both subject and partner will be asked to fill out a diary each day. The     subjects will record the type of caffeine consumed, time at which each beverage was ingested,     the total minutes of physical exercise, any caffeine withdrawal symptoms, quality of sleep,     and energy in the morning. The partner (reporter) will rate his or her own sleep quality and     energy in the morning, as well as the snoring level of the subject. Beginning the second week     of the study, the subject will reduce caffeine intake to half the baseline consumption, and     on the third week, will eliminate caffeine altogether.      At the end of each week, the participants will be asked to mail their diaries in to the     researchers and start a new series of entries. The study team will also call each week to     answer any questions or concerns of the subject and reporter, and encourage continued     reporting. When six weeks have elapsed following the completion of the last diary, the     investigators will make a final call to the participants to record their current level of     snoring, quality of sleep, and daily energy level.   "
213191|NCT00641823|"     The proposed project will address the measurement and ramifications of out-of-home mobility     problems in various orthopedic disorders in an innovative way, using advanced tracking     technologies.   "
213192|NCT00641836|"     Recent researches indicate that impairment of vascular and endothelial homeostasis plays a     major role in the initiation and development of IPAH.We have recently reported the safety and     feasibility data for autologous endothelial progenitor cells (EPCs) injection in patients     with IPAH. Yet many questions remain unanswered: what is the ideal quantity of EPCs for     therapy, the duration of the therapeutic effect, and moreover, the potential toxicity of such     therapy. To help answer these questions, we designed the one year follow-up to investigate     the safety and efficacy of autologous EPCs injection in patients with IPAH.   "
216941|NCT00690716|"     The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the     treatment of mild headaches in people who have migraines.   "
213193|NCT00641849|"     This research will focus on the effect of a 6-month behavioral intervention delivered via the     World Wide Web that is aimed at increasing physical activity levels and decreasing dietary     fat intake in a general population of adults. The study will be randomized and blinded. We     are also planning to study subjects' compliance and retention rates when enrolled in a     completely on-line study.   "
213194|NCT00641862|"     This study is a randomized, double-blind trial among 300 pregnant Indian women in order to     determine the effectiveness of vitamin B12 supplementation in improving maternal B12 status.     Secondary aims for this trial include maternal hemoglobin, maternal weight gain during     pregnancy and infant birthweight. All women will receive standard of prenatal obstetric care,     including routine supplementation with iron and folate.   "
213195|NCT00641875|"     Arterial stiffness refers to the accumulation of extracellular deposits of matrix and calcium     which reduce blood vessel compliance. Although there is growing evidence that increased     arterial stiffness is associated with chronic kidney disease (CKD), its pathogenesis is     unclear. Pulse wave velocity (PWV) and augmentation index (AIx) provide tools for estimating     arterial stiffness, and therefore predicting cardiovascular morbidity and mortality. The aims     of the study are: (1) compare the effects of nocturnal and conventional haemodialysis on     arterial stiffness, and (2) examine the relationship between arterial stiffness and clinical     and biochemical parameters.   "
213196|NCT00641888|"     Cardiovascular risk appears to be linked to some degree with inflammation. HIV medications     have been linked with cardiovascular risk. In this study we will be measuring levels of     chemicals in the body associated with inflammation before and after starting HIV medications     in patients with HIV. We hope to understand what happens to these chemicals once a patient     with HIV is started on these medications to understand their role in cardiovascular risk.   "
213197|NCT00641901|"     Compelling evidence suggesting a possible link between maternal pregnancy-related     periodontitis (gum disease) and spontaneous pre-term birth (PTB)makes effective management of     oral health a relevant and significant obstetrical-dental issue.      The purpose of this pilot study is to determine whether intensive education and counseling     can help pregnant women learn to maintain excellent oral health and in doing so reduce the     severity of gingivitis and periodontitis during their pregnancy. Failure to effectively     remove the plaque biofilm from the surface of teeth every day is the crucial event leading to     the development of gingivitis and plaque-induced gingivitis is the most common form of     periodontal disease in pregnant women.      We therefore hypothesize that patients can be taught to effectively modulate their own     disease through intensive education and meticulous home care coupled with closely monitored     behavior modification.      We believe this may be an effective approach toward improving oral health with the potential     to reduce adverse pregnancy outcomes.   "
213198|NCT00641914|"     A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma.     Patients will receive either Pulmicort or a non-active treatment for three years. Neither     patients or investigators will be aware of the treatment received. After three years of     treatment all patients will receive Pulmicort for 2 further years.   "
213201|NCT00641953|"     The purpose of this study is to compare the effectiveness of two different dose of IMX-150 to     that of placebo (non-active) in the treatment of diabetic peripheral neuropathy pain of the     feet.   "
213204|NCT00642005|"     Laparoscopic surgery allows surgeons to remove bowel via small incisions. To allow insertion     of a camera and instruments, cold and dry gas is blown into the abdominal cavity. This     project investigates the use of warmed, humidified gas in laparoscopic surgery. The     hypothesis is that this will result in less damage to internal surfaces, and shorten recovery     time. Previous studies have demonstrated positive outcomes in laparoscopic gallbladder     operations. The investigators plan to study patients undergoing laparoscopic colon     operations, as these operations are longer and the effect of humidification will be     magnified. The investigators will enroll 74 patients: 37 will have the operation with cold     dry gas, and 37 will have warm, humidified gas. The investigators will measure intraoperative     heat loss, postoperative pain, fatigue, nausea and vomiting, and time to return of bowel     function.   "
213205|NCT00642018|"     The primary purpose of this study is to determine whether LY2181308 in combination with     docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.   "
213206|NCT00642031|"     Primary objective:      To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of TCN-PM     (Triciribine) when administered as an approximately one-hour intravenous infusion on a weekly     schedule on days 1, 8 and 15 in a 28 day cycle in patients with advanced hematologic     malignancies;      To determine the pharmacokinetics (PK) of Triciribine following study drug administration.      Secondary objective:      To observe the anti-tumor effects of Triciribine, if any occur   "
213207|NCT00642044|"     Cross-linking of the cornea increases the mechanical and biochemical stability of the stromal     tissue. The purpose of this study is to assess the effectiveness of riboflavin-ultraviolet     light induced cross-linking of corneal collagen in improving visual acuity and reducing     progression of keratoconus in the Brazilian population.   "
213208|NCT00642057|"     Although the results of studies looking at tetrabenazine have shown its effectiveness in the     management of hyperkinetic(too much) movement disorders, it has not been made available in     the U.S. The drug must be obtained from Cambridge Laboratories, the distributor, using an     individual IND (#16,161). The cost of the drug is passed on to the patient. The purpose of     the protocol is to provide an efficacious drug, with few side effects, in an attempt to get     rid of a variety of incapacitating dyskinesias (abnormal movements).   "
213209|NCT00642070|"     This study is being done to identify those elements of the immune response that may     predispose a woman to recurrent urinary tract infection. We suspect that lesser effectiveness     of certain components of the host response will lead to recurrent urinary tract infection. We     will also evaluate the role that the bladder reservoir may play in recurrent urinary tract     infection.   "
213210|NCT00642083|"     The purpose of this study is to demonstrate the efficacy of a PTFE covered stent-graft in the     prevention of outflow re-stenosis in loop fistula in a prospective trial.   "
213277|NCT00635401|"     The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese     smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers.     Safety is evaluated by adverse events, laboratory tests, and other safety tests.   "
213211|NCT00642096|"     The purpose of this research study is to determine if treatment with the combination of     metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure     than treatment with either of the two drugs alone. The study will also determine which     combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering     blood pressure (without unacceptable side effects), and whether it is possible to combine     both drugs in a single tablet to simplify blood pressure treatment.   "
213212|NCT00642109|"     The midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a     well established technique for treating female stress urinary incontinence in patients with     (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Currently,     several anatomical approaches are developed and investigated to simplify this minimal     invasive technique and make it safer. While the retropubic approach consists of the passage     of the needles from under the midurethra up behind the pubic bone through the cavum retzii,     the transobturator technique traverses the foramina obturatoria. Intraoperative complications     like bladder perforation (in 4%) can be treated conservatively, while postoperative     complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary     retention) are troublesome, impair the quality of life and require occasionally surgical     sling release (transection of the sling). The aim of this study is to compare quality of     life, postoperative voiding dysfunction, success rates and tape position after retropubic and     transobturator sling procedure.        -  Trial with surgical intervention   "
213213|NCT00642122|"     A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when     given to asthma patients aged 12 years and above.   "
213214|NCT00642135|"     Pupillary dilation to perform a fundus in premature newborns and neonates is often difficult     to obtain, because of the non mature iris sphincter. The fundus is essential to detect     retinal anomalies (as retinopathy of prematurity or chorioretinal or disk anomalies). The aim     of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two     mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study     will evaluate the mydriasis in premature newborns, neonates and infants justifying a     mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus     reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic     insert Mydriasert® can control drug dispensation and decrease the number of nurse     interventions to obtain mydriasis in patients.   "
213215|NCT00642148|"     Phase IIa, randomised, double-blind, double-dummy, parallel group, multi-centre study in     subjects diagnosed with moderate chronic obstructive pulmonary disease (COPD). The primary     objective is to evaluate the effects of 12-weeks of treatment with GW856553 7.5 mg twice     daily (BID) compared with placebo on the percentage of sputum neutrophils at 12 weeks. Twelve     weeks of treatment with SERETIDE 50/500 BID will be compared with placebo for effect on     sputum neutrophils as a positive control arm in the study   "
213216|NCT00642161|"     A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently     approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents     who have asthma. In addition the study evaluated the functionality of the new inhaler at the     end of its intended life.   "
213243|NCT00642512|"     The primary purpose of the study is to determine the efficacy of oral dronabinol versus     standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced     nausea and vomiting (CINV) or retching by measuring the incidence of total response of nausea     and vomiting and/or retching following administration of moderate-to-high emetogenic     chemotherapeutic agents.   "
213217|NCT00642174|"     This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator     controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers.     The study will compare platelet function following a prasugrel loading dose and 1 week of     prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose     clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who     have coronary artery disease. Various assays of platelet function will be used in this study.     Platelet function will be studied using the following assays: Accumetrics VerifyNowTM P2Y12,     Light Transmittance Aggregometry (LTA), Vasodilator-associated stimulated phosphoprotein     (VASP), and Thromboelastography (TEG)-platelet mapping.   "
213218|NCT00642187|"     A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently     approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have     asthma and are currently being treated with inhaled steroids. In addition the study evaluated     the functionality of the new inhaler at the end of its intended life.   "
213219|NCT00642200|"     The study aims at detecting possible differences between an open (Lichtenstein) and a     video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences     monitored are further recurrence and chronic pain as well as primary complications.   "
213220|NCT00642213|"     Our primary goal is to study temporal trends in the incidence rate, causes, treatment, and     outcome of stroke among a large biracial metropolitan population of 1,349,351, of whom     215,611 (15%) are black (2000 Census). Such data are critical for the planning, intervention,     and evaluation of public health efforts to decrease the mortality and morbidity due to stroke     in the United States.      We have completed this goal for 1993-94, 1999, 2005, and 2010. We ware in the process of     collecting this data for 2015. In the 2015 study period we will also be ascertaining 3 year     recurrence rates for all incident stroke events.   "
213221|NCT00642226|"     The purpose of this study is to determine whether pars plana vitrectomy in combination with     triamcinolone acetate is effective in the treatment of macular edema due to branch retinal     vein occlusion.   "
213222|NCT00642239|"     This multicentered clinical trial is going to find out the radio-sensitization action of     sodium glycididazole in radiochemotherapy for esophageal cancer.   "
213223|NCT00642252|"     The primary goals of this project are to determine the anticaries benefits of a prototype     multi-mineral mouthrinse containing 225 ppm fluoride and 30 ppm of a Ca through the     remineralization of enamel white-spots (non-cavitated lesions). The selection of patients     with pre-existing white-spot lesions will permit an opportunity to evaluate the efficacy of     the multi-mineral mouthrinse in reminerzalizing and/or inhibiting progression of enamel     white-spot lesions.   "
213224|NCT00642265|"     Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two     groups: conservative or operative treatment. The conservative arm is treated with a sling for     6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.      Patients are clinically and radiologically evaluated during 1 year. A economical analysis is     also done.   "
213225|NCT00642278|"     The purpose of this study is to evaluate the effectiveness, safety, and tolerability of     JNJ-28431754 compared with placebo in patients with type 2 diabetes.   "
213226|NCT00642291|"     To obtain safety and efficacy data for antiretroviral regimens containing emtricitabine in     HIV-1 infected pediatric subjects. To determine emtricitabine concentrations in HIV-1     infected pediatric subjects and, if necessary, to refine the dose of emtricitabine to achieve     concentrations comparable to those in adults given 200 mg emtricitabine once-daily.   "
213227|NCT00642304|"     This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when     administered for the maintenance of hemoglobin levels in participants with chronic renal     anemia, not on dialysis. Participants currently receiving maintenance treatment with     subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A.,     with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from     the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study     start.   "
213228|NCT00642317|"     The overall goal of this study is to identify and understand the environmental     characteristics associated with tobacco use and tobacco initiation among Asian American youth     from primarily two communities: Chinese and Vietnamese. The specific aims of this study are     twofold:        -  To estimate the prevalence of smoking among Chinese and Vietnamese youth in the Houston          area compared with non-Asian American communities.        -  To study the relationship between environmental characteristics (both pro- and          anti-tobacco) and tobacco initiation and use among Chinese and Vietnamese youth.        -  To explore if degree of acculturation is related to tobacco initiation and use among          Chinese and Vietnamese youth.   "
213229|NCT00642330|"     it is a prospective randomized simple-blinded pilot trial with the principal aim to compare     efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative     closure of PDA in very low birth weight infants. The likelihood of ductal closure with only     one or two doses of treatment is a secondary objective.   "
213230|NCT00642343|"     The purpose is to test the balance of children with unilateral,bilateral cochlear implants     and patients having unilateral implants before,bilateral implants after surgery,using the     Bruininks-Oseretsky Test 2nd ed. to find out if the cochlear implants have an effect.   "
213231|NCT00642356|"     The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to     the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose     wearing off in persons who have Parkinson's disease.   "
213240|NCT00642473|"     This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%)     topical cream in the prevention and treatment of rash associated with Tarceva treatment, in     participants with non-small cell lung cancer. The first cohort of participants enrolled in     the study will be treated twice daily with metronidazole cream on the right side of the face     and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily).     The corresponding body parts on the left side will be treated according to local standard     procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated     participants will only receive twice daily treatment with metronidazole cream if and when     they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The     anticipated time on metronidazole treatment is less than (<) 3 months, and the target sample     size is <100 individuals.   "
213232|NCT00642369|"     This study will apply polysomnography (PSG) to evaluate the effect of quetiapine fumarate on     sleep architecture. Most of previous studies evaluated sleep by self-reported questionnaires     during the antipsychotic treatment (clozapine, risperidone, olanzapine, et al), while only a     few studies with PSG evaluation had some limitation, such as: small sample size, respective     or cross-sectional, potential sleep disorders, et al. In this study, we will investigate both     subjective and objective effect of quetiapine fumarate in improving sleep quality in     schizophrenic patients by PSG as well as psychiatric scales. The control drug in this study     is the typical antipsychotic - haloperidol. It could increase sleep duration and efficiency     by mostly increasing the S2 without effect on rapid eye movement (REM) sleep and slow wave     sleep (SWS). The patients will be randomised into two groups as a parallel design. This study     is designed as rater blinded to reduce the bias in evaluation. It is suggested that the     sedative effect of quetiapine fumarate could diminish in 2 weeks, therefore, we use 4 weeks     to ensure the change of sleep quality in this study, which could be helpful for the     evaluation of relative short and middle term effect of quetiapine fumarate on sleep quality.   "
213233|NCT00642382|"     The purpose of this study is to determine whether Agilus is safe and effective in the     treatment of mild to moderate ankle osteoarthritis.   "
213248|NCT00642577|"     This 2 arm study will assess the efficacy and safety of Avastin in combination with     irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid     alone, as first line treatment in Chinese patients with metastatic colorectal cancer.     Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2     weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for     4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil     500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease     progression, and the sample size is 100-500 individuals.   "
213249|NCT00642590|"     Researchers believe that certain lifestyle factors can influence a couple's ability to     conceive and have a baby. The ISIS Study will look at the health habits of couples who are     planning their first pregnancy, and then attempt to measure the effect these habits have on     the couple's fertility. The ISIS Study hopes to clarify the link between lifestyle and     fertility, and believes that information gained in this project may help future couples in     their attempts to conceive.   "
213278|NCT00635414|"     This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg     Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people     with symptoms of Gastroesophageal Reflux Disease (GERD)   "
213234|NCT00642395|"     Intensification with autologous stem cell (ASCT) is currently the most effective treatment     for subjects under 65 and the essential goal is to achieve complete response (CR) or very     good partial response (VGPR= greater than 90% reduction of monoclonal component). However,     only 50% of patients achieve this CR/VGPR even with tandem ASCT early in the course of     disease.      Optimization of the conditioning regimen could improve this CR/VGPR rate. The combinaison of     Velcade and HD Melphalan has never been evaluated. However, at conventional doses, Velcade     potentiates the antimyeloma effect of Melphalan without inducing any common toxicity.      This study will be conducted in patients under the age of 65 with de novo multiple myeloma or     in first relapse, with Salmon and Durie stage of III, II, I with one symptomatic bone lesion     (radiological)and no contraindication to intensification. The primary objective will be to     increase the CR/VGPR rate 3 months after autologous peripheral blood stem cell     transplantation conditioned by Velcade-Melphalan from 40% to 70%. With alpha=5% and bêta=10%,     61 patients will be included.      Secondary objectives will be to assess the toxicity of the Velcade-Melphalan conditioning     regimen, the progression-free survival and the overall survival after intensification.     Response rates will be evaluated according to the response criteria defined by. Analysis will     be performed on an intention-to-treat basis.      After conventional induction therapy and PBSC collection, patients will be offered this new     conditioning regimen. they will be free to refuse this regimen, in which case they will     receive standard intensification therapy by Melphalan 200 mg/m² followed by autologous stem     cell transplantation.      Evaluation will occur at 3 months post intensification.   "
213235|NCT00642408|"     Intrauterine Growth Retardation is the most important determinant of mortality and morbidity     in the neonatal period. It is also a very important factor in predicting nutritional status,     health and development in childhood. It even influences health in adult life, contributing to     the vicious cycle of disease and poverty. The high rate IUGR in DCs represents therefore a     major public health problem. Maternal malnutrition is usually assumed to be a major     determinant of the problem in these countries. An increasing amount of evidence points to the     potential role played by micronutrient deficiencies during pregnancy. The adverse effect on     birthweight of maternal iron deficiency anaemia, lack of zinc and lack of iodine have been     documented. A similar effect is suspected for Vitamin A, Magnesium, Calcium, Copper,Thiamine,     Pyridoxine and Folic acid. It seems that not one specific deficiency alone is responsible for     this adverse effect, but rather a combination of them. Therefore, it is expected that     covering needs of pregnant women by a multivitamin-mineral supplement will have an effect of     public health importance on children's health.      This study has the objective of improving children's health by preventing intrauterine growth     retardation through the provision of multivitamin-mineral supplements during pregnancy.      This research includes 2 constituents:        1. a pilot phase during which socio-anthropological, nutritional and epidemiological          aspects of IUGR will be assessed through qualitative and epidemiological methods.        2. a double-blind, randomised, placebo-controlled trial, including 1215 pregnant women          aimed at testing 3 hypotheses: supplementing pregnant women with a multivitamin-minerals          mix will improve fetal growth; improved fetal growth will have a positive effect on          health and growth during infancy; covering nutritional needs of lactating women with a          multivitamin-minerals mix during 3 months after delivery will improve health and growth          of infants.      The trial is planned in Hounde District, Burkina Faso, in collaboration with Centre Muraz,     which plays a leader role in research and services providing at the district level and in     policy recommendations at the national level. This will ensure that the study findings are     incorporated into on-going district programmes with possible replication at the national     level. The research lasts from June 2003 to October 2006.   "
213236|NCT00642421|"     The purpose of this study is to assess the safety profile of a new prolonged release     formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or     6 weeks in acromegalic patients.   "
213237|NCT00642434|"     The purpose of this study is to determine if there are differences, (benefits) between     carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes.     Specifically we will be looking at differences in blood pressure and blood sugar control,     endothelial function, inflammation, oxidative stress and coagulation.      Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each     subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done,     Inflammatory and oxidative stress markers will be measured. Endothelial function will be     measured using brachial artery ultrasound and laser skin Doppler   "
213238|NCT00642447|"     to assess the effect of Heliox with Noninvasive positive pressure ventilation to decrease     dyspnea and improve physiologic and respiratory measures in patients with a previous exposure     to Sulfur Mustard gas.   "
213239|NCT00642460|"     This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in     patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate     clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be     randomized 2:1 to receive iv infusions of RoActemra/Actemra (8mg/kg iv for patients >=30kg,     or 12mg/kg for patients <30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will     be continued throughout. After 12 weeks of double-blind treatment, all patients will have the     option to enter Part II of the study to receive open-label treatment with RoActemra/Actemra     for a further 92 weeks, followed by a 3-year continuation of the study in Part III in which,     for patients who meet specific criteria, an optional alternative dosing schedule decreasing     the study drug administration frequency will be introduced. Anticipated time on study     treatment is up to 5 years.   "
213241|NCT00642486|"     This multi-site project compares compares the efficiency of a home-based portable monitoring     strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive     airway pressure treatment of obstructive sleep apnea in adults.   "
213244|NCT00642525|"     Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow     is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be     superior. This is the first study to compare radiographic contrast study and endoscopy for     the identification of local complications after subtotal esophagectomy.   "
213245|NCT00642538|"     20 eligible subjects will be enrolled into the treatment phase of the trial.   "
213246|NCT00642551|"     From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective     cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and     matrix-Gla protein (in the arterial vessel wall). The question remains whether     supplementation with MK-7 also leads to measurable improvements of bone and vascular health.     The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently     healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of     an MK-7- supplement will be monitored during three years on bone quantity and quality and on     vascular characteristics and function.   "
213247|NCT00642564|"     The purpose of this study is to collect data from patients who are diagnosed with epilepsy     and are followed up in epilepsy clinics.   "
213250|NCT00642603|"     This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of     Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12     cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were     randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and     oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to     receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment     was until disease progression, and the target sample size was 100-500 individuals.   "
213251|NCT00642616|"     Examine the effects of TI in combination with an anti-diabetic regimen including inhaled     insulin versus anti-diabetic treatment without inhaled insulin on lung function & pulmonary     safety   "
213252|NCT00642629|"     It is not fully clear how rheumatoid arthritis originates and develops, but it is understood     that multiple genetic and environmental factors interact to trigger its onset. The immune     system attacks the joint synovium, which damages the cartilage and bone in the joint by     increasing the number of inflammatory cells and forming new blood vessels in the joint space.     STA-5326 mesylate inhibits the production of IL-12 and IL-23 and therefore may inhibit Th-1     cytokine production. A reduction in the Th-1 response has the potential to minimize or     eliminate joint damage caused by the immune response in rheumatoid arthritis. This study is     designed to assess whether the proposed mechanism of action is associated with a reduction in     inflammation in the synovium of patients who have rheumatoid arthritis.   "
213253|NCT00642642|"     The purpose of this study is to evaluate the safety profile and the treatment effect of     Isolagen TherapyTM and placebo when administered to facial acne scars.   "
213254|NCT00642655|"     The purpose of this study is to examine the safety and efficacy of IVIG in combination with     Rituximab to lower the level of HLA-sensitive antibodies and block their ability to attack a     transplanted organ in patients who are highly HLA-sensitized and are awaiting     transplantation.   "
213255|NCT00642668|"     This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene     glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for     correction and/or maintenance of hemoglobin levels in participants with chronic kidney     disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA)     or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy     polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram     (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size     was 200 individuals.   "
213256|NCT00642681|"     Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge   "
213257|NCT00642694|"     Hypothesis I: Patients in the SSRI + ramelteon treatment group will achieve remission     (defined as an IDS-C30 score of 11 or less) more quickly than those in the SSRI + placebo     group.   "
213258|NCT00642707|"     The purpose of this study is:        1. To assess the antiviral activity of PRO 140        2. To assess the safety and tolerability of PRO 140        3. To generate additional PK, PD and safety data of PRO 140   "
213271|NCT00635323|"     To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with     inoperable hepatocellular carcinoma.   "
213272|NCT00635336|"     The purpose of this study is to evaluate the safety and clinical efficacy of novel     vaccination for advanced bladder cancer.   "
213273|NCT00635349|"     The purpose of this study is to compare the effectiveness of tramadol hydrochloride 37.5     milligram (mg) plus acetaminophen 325 mg maintenance with that of non-steroidal     anti-inflammatory drugs (NSAIDs) maintenance in participants with knee osteoarthritis (a     progressive and degenerative joint disease, in which the joints become painful and stiff)     whose pain was relieved after the add-on treatment of tramadol hydrochloride to NSAIDs.   "
213346|NCT00645749|"     The hypothesis of this study is that helminth-induced immunomodulation therapy (HINT) will be     safe and effective when administered orally in patients with relapsing-remitting multiple     sclerosis (RRMS).   "
213259|NCT00642720|"     Study Synopsis Study Title: Double blind, single centre, cross-over study on the effects of     weekly subcutaneous administration of 40 mg pegvisomant or placebo on quality of life and     insulin sensitivity in acromegalic patients with normal serum IGF-I concentrations during     long-term treatment with long-acting somatostatin analogs      Study Objectives:        1. To determine whether the addition of weekly pegvisomant administrations improves quality          of life        2. To determine whether the addition of weekly pegvisomant administrations improves insulin          sensitivity      Study Population: Acromegalic patients, who have normalized their serum IGF-I levels down to     the upper 25 centiles of normality during long-term treatment with monthly injections of a     long-acting somatostatin analogue Number of Subjects: 20      Procedures:        -  Patients on treatment with Sandostatin LAR (SL) 20 - 30 mg per months i.m. or patients          on treatment with Lanreotide autosolution (LA) 90 - 120 mg deep s.c. will be enrolled.        -  For 4 months, all subjects will also receive weekly s.c. injections of either placebo or          a fixed dose of 40 mg pegvisomant        -  After a 4 weeks wash-out period, patients will switch from either placebo to pegvisomant          or from pegvisomant to placebo        -  Before, and after 2 and 4 months of each treatment period, serum efficacy parameters and          quality of life (AcroQol ™/ PASQ™) will be assessed.        -  Before and after 4 months of each treatment period, pituitary tumor size and insulin          sensitivity (HOMA/SIGMA model) will be assessed. Duration of study: 9 months      Hypothesis:      •We postulate that co-administration of the growth hormone receptor antagonist pegvisomant     will improve QoL and insulin sensitivity   "
213260|NCT00642733|"     This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in     patients with locally advanced, unresectable or metastatic pancreatic cancer. Patients will     receive Tarceva 100mg po daily, in combination with gemcitabine 1000mg/m2 iv weekly for 8     weeks, followed by weekly for 3 weeks of each 4 week cycle. The anticipated time on study     treatment is until disease progression, and the target sample size is <100 individuals.   "
213261|NCT00642746|"     The purpose of this study is to see if alternating chemotherapy with erlotinib increases     tumor shrinkage in people with metastatic colorectal cancer. The investigator will also be     studying the side effects (good and bad) of alternating chemotherapy with erlotinib on     metastatic colorectal cancer.   "
213262|NCT00642759|"     The purpose of this research study is to learn more about whether the combination of drugs     carboplatin, Abraxane and Avastin helps treat non-small cell lung cancer (NSCLC). One of the     standard treatments for advanced NSCLC is the combination of the drugs carboplatin,     paclitaxel and Avastin. Paclitaxel can be associated with severe side effects that may make     the treatment difficult to tolerate. Some of these side effects are caused by the solution     used to dissolve paclitaxel before it can be administered. Abraxane is a different form of     paclitaxel that does not need to be dissolved by this solution. Abraxane is approved for the     treatment of breast cancer but is not approved to treat NSCLC. We will also be trying to     learn more about how the drug Avastin may work to treat cancer.   "
213263|NCT00642772|"     Osteoarthritis (OA) is a common cause of pain and disability. Physical therapy is a key part     of treatment for OA, but VA Medical Centers are often limited in their capacity to provide     physical therapy services for veterans with knee OA. The goal of this study is to perform a     preliminary work on a group-based physical therapy program for veterans with knee     osteoarthritis (OA), in preparation for a larger project. This work will allow us to assess     the feasibility of conducting group-based physical therapy program and to plan a larger grant     submission based on the findings of this initial study. We hypothesize that the group-based     program will be feasible to administer and will result in improved pain and function.   "
213264|NCT00642785|"     The research question to be addressed is whether indirect phototherapy based activation of     the body's alternative cellular energy (ACE) pathway will lead to expedited healing of active     herpes simplex virus (HSV) and herpes zoster virus (HZV)skin lesions, and also possibly     inhibit both latent HSV infections and residual HZV infections.   "
213265|NCT00642798|"     To support the registration of sitagliptin 100mg in china.   "
213266|NCT00642811|"     The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet     medication, affects platelets. Anti-platelet agents are medications that block the formation     of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding,     but when they form inside the arteries their formation is linked to a risk of medical     problems such as heart attack and stroke. This study investigated the effect of Ticagrelor on     inhibition of platelet aggregation compared with clopidogrel in patients previously     identified as non-responsive to clopidogrel.   "
213267|NCT00642824|"     This single arm genetic substudy of MO19390 will test the hypothesis that there is a positive     relationship between mRNA BRCAI levels and the response to different chemotherapy     combinations plus Avastin. A subset of patients participating in MO19390, and receiving     Avastin 15mg/kg iv on day 1 and subsequently once every 3 weeks, will undergo BRCAI mRNA     expression determination. Depending on the BRCAI mRNA level (low, medium or high) they will     receive a different chemotherapy regimen in combination with Avastin:     a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or     docetaxel. Avastin treatment will continue after completion of chemotherapy cycles until     disease progression, and the target sample size is 100-500 individuals.   "
213268|NCT00642837|"     The objective of this observational study is to assess improvement of quality of life in the     patients who are administered Tramadol 37.5mg/Acetaminophen 325mg tablets for 10~14 weeks     according to the investigator's discretion in clinical practice.   "
213269|NCT00635297|"     Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures.     Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those     that have been treated with percutaneous vertebroplasty.      The purpose of the study is to determine if prophylactic vertebroplasty of unfractured     vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in     adjacent vertebrae.   "
213270|NCT00635310|"     Percutaneous liver biopsy (PLB) is the gold standard for grading necroinflammation and     staging fibrosis in patients with chronic viral hepatitis. Whether the use of     1-deamino-8-D-arginine vasopressin (DDAVP) before PLBs in hemodialysis (HD) patients with     chronic viral hepatitis has comparable safety profiles to those with normal renal function     (NRF) has not been evaluated in prospective studies.   "
213274|NCT00635362|"     The study is a randomized controlled trial comparing outcomes of immediate postplacental     insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval     insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled     cesarean delivery.      Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at     12 months after delivery will be higher in the group randomized to immediate post-placental     insertion.   "
213275|NCT00635375|"     Hyperbilirubinemia is a common problem for term and preterm newborns in intensive care     nurseries around the world. It is a condition in which there is too much bilirubin in the     blood. Bilirubin is a substance that is naturally released when red blood cells break down.     In the early newborn period, multiple factors lead to an abnormally elevated bilirubin level.     Large amounts of bilirubin can circulate to tissues in the brain and may cause seizures or     brain damage. About 6.1% of term newborns and a higher percentage of preterm newborns develop     hyperbilirubinemia that requires treatment. Initiating treatment depends on many factors,     including the cause of the hyperbilirubinemia, the level of serum indirect bilirubin, the     rate of indirect bilirubin rise, and the age of the patient. The goal of treatment is to keep     the level of bilirubin from rising to dangerous levels.      The bilirubin molecule absorbs light. Therefore, treatment of hyperbilirubinemia involves     exposure of the baby's skin to special blue spectrum light. Phototherapy is globally     recognized as the standard of care for treatment of elevated indirect hyperbilirubinemia in     the neonatal period. This light exposure converts water-insoluble indirect bilirubin to a     more easily excreted soluble molecule. Over the last five years, several devices have been     introduced that emit high intensity light in the blue portion of the visible light spectrum.     However, despite frequent use of such therapy, the effectiveness of different phototherapy     devices has not been adequately compared. The objective of this study is to compare the     efficacy of the blue LED fiberoptic phototherapy with the metal halide spot phototherapy     versus blue LED bank light phototherapy versus a combination of tandem therapy on lowering to     total serum bilirubin.   "
213276|NCT00635388|"     The primary objective of this study is to determine the appropriate study design for a     full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in     elementary school children relative to a placebo control.   "
213280|NCT00635440|"     Skeletal muscle atrophy is associated with catabolic conditions such as major surgical     interventions and leads to reduced muscle strength, increased clinical complications and     prolonged convalescence. Several studies revealed immobilisation as a major stimulus for     muscle wasting in severely ill patients. This study investigates the potency of neuromuscular     electrical stimulation on skeletal muscle growth factors and degradation processes in major     abdominal surgery patients.   "
213281|NCT00635453|"     A cluster randomized field trial to evaluate the impact that training healthcare workers in     healthy feeding practices has on the nutrition and health of children.   "
213282|NCT00635466|"     The purpose of this study is to examine the technical and oncological feasibility of     laparoscopic surgery for rectal carcinoma   "
213283|NCT00635479|"     The purpose of this research is to study the efficacy and cost effectiveness of the VAC     device in comparison to traditional gauze wound dressing in pelvic, acetabular and hip     fractures, specifically to see if there is a reduction in the incidence of post operative     surgical wound drainage, infections, and hospital stay.   "
213284|NCT00635492|"     Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual     clinical practice will be enrolled and followed up for two years in order to describe actual     practice with regards to the time on initial treatment regime, whether treatment regimens are     being modified, what treatment modifications are made, and clinical and patient-reported     outcomes.   "
213285|NCT00635505|"     This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA     Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered     dose inhaler (MDI) of Albuterol (Treatment T), in comparison with:        1. Placebo control: (HFA propellant only, Treatment P); and        2. Active control: 3M/Key's Proventil-HFA (Treatment R).      The treatments will be given as self-administered oral inhalations in adult and adolescent     patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week     study is two actuations four times daily (QID).   "
213286|NCT00635518|"     A cluster randomized field trial to evaluate the impact that training healthcare workers in     healthy feeding practices has on the nutrition and health of children.   "
213287|NCT00635531|"     The purpose of this study is to evaluate the efficacy, safety, tolerability, and     pharmacokinetics of alprazolam extended release (XR) for the treatment of adolescents with     panic disorder   "
213288|NCT00635544|"     The main objective of this study is to evaluate the effects of two diets with different     glycemic index and fibre content on glucose metabolism and plasma lipid profile of 80     adolescents in 4 European centres.      Secondary objectives are to evaluate the effects of the two standardized diets on selected     hormones and variables linked to inflammatory status.   "
213289|NCT00635557|"     This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing     glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin     to three separate cohorts. Study endpoints will include determination of the maximum     tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity     of MPC-6827 when given with carboplatin.   "
213318|NCT00643123|"     The purpose of this study is to investigate the efficacy of allopurinol as an augmentation     agent for treatment resistant mania and mixed mania.   "
213290|NCT00635570|"     The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing®     vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side     effects, overall acceptability and intent to continue use of the method. The study is focused     on the acceptability of the vaginal ring among female undergraduate or graduate students.   "
213291|NCT00635583|"     Building stronger bones during pubertal growth could reduce lifelong fracture risk. This     project is an 18 month dairy intervention study for overweight and healthy weight 4th-8th     grade boys and girls. Half of the girls will receive dairy products to add to their habitual     diet (milk, yogurt, and cheese) to equal three products per day, while the other half will     remain on their normal diet. All participants will attend four study visits, each 6 months     apart. At these visits height, weight, bone density and geometry, and fat and lean mass will     be measured. This study aims to show that meeting calcium requirements by eating dairy     products builds bigger, stronger bones, and that this effect may be enhanced in overweight     boys and girls. The effect of the dairy intervention on body fat, lean mass, and weight, as     well as the mechanisms and predictors of changes in bone mass and size and body composition     will also be evaluated.   "
213292|NCT00635596|"     This phase I dose escalation study is intended to define the safety, tolerability and maximal     tolerable dose (MTD) of MT110 in patients with advanced solid tumors.   "
213293|NCT00635609|"     Randomized, multi-center, open label, active-comparator study to compare the efficacy and     tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with     moderate to severe acne vulgaris.   "
213294|NCT00635622|"     This is a phase IIa clinical trial in women with bacterial vaginosis. This study will     determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy     (metronidazole) is effective in colonizing the vagina with the lactobacillus bacteria found     in normal vaginal flora.   "
213295|NCT00635635|"     Military sexual trauma (MST) is a significant women's mental health issue. There is a crucial     need for effective therapies for MST-related posttraumatic stress disorder (PTSD) that are     well-tolerated and can be flexibly administered in a variety of treatment settings. Guided     imagery is a novel, transportable intervention technique that meets these requirements and     warrants research in PTSD. The proposed study will be a randomized controlled trial of the     Guided Imagery for Trauma (GIFT) intervention for women veterans with MST-related PTSD. This     minimal contact intervention is designed to increase coping, affect management and relaxation     skills, and to fostering more positive images and beliefs associated with surviving trauma.     The feasibility and tolerability of GIFT have already been demonstrated in an open-label     pilot of 15 women veterans with MST-related PTSD, with very promising initial results.   "
213296|NCT00635648|"     To evaluate the safety, tolerability, and efficacy of caspofungin for the treatment of     esophageal candidiasis and invasive candidiasis to support the registration of caspofungin     for these indications in China.   "
217105|NCT00685789|"     The purpose of this study is to observe the influence of Deqi and neuropsychological factors     on effects of acupuncture treatment for Bell's Palsy.   "
213297|NCT00642850|"     This single arm study will assess the efficacy, safety and tolerability of once-monthly     administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis     participants with chronic renal anemia. Participants will receive monthly intravenous     injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the     dose of epoetin administered in the week preceding first study drug administration. The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
213298|NCT00642863|"     It is common in many populations that babies develop iron deficiency or iron deficiency     anemia (that is, too few healthy red blood cells due to lack of iron). This is due to rapid     growth in infancy combined with limited sources of iron in the infant diet. The amount of     iron the baby receives across the placenta during pregnancy is another important factor. This     study focuses on infants who are born with less than the usual amount of iron in their     bodies. The purposes of the study are to assess effects of lower iron at birth on infant     behavior and development and to determine if providing iron supplements to such infants     beginning at 6 weeks fosters healthier development. Another part of the study will determine     the effects of iron deficiency anemia at different times during infant development.   "
213299|NCT00642876|"     The purpose of this clinical investigation is to evaluate the safety and effectiveness of the     ACD in the single level surgical treatment of patients with symptomatic cervical degenerative     disc disease. The primary follow-up information obtained from this clinical investigation are     used to support a PMA application for the ACD.   "
213300|NCT00642889|"     To determine the long-term safety and efficacy of a dose range of safinamide of 50-200     mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic     Parkinson's disease who are currently receiving a stable dose of a single dopamine (DA)     agonist.   "
213301|NCT00642902|"     To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces     central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as     assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study     medication is administered via subcutaneous (under the skin) injections.   "
213302|NCT00642915|"     To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood     glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the     ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination     therapy   "
213303|NCT00642928|"     The objective of this trial is to define the minimum effective dose of BF 2.649 between 5 mg,     10 mg, 20 mg or 40 mg versus placebo in reducing the Excessive Daytime Sleepiness of     Parkinson's disease patients   "
213319|NCT00643136|"     The purpose of this study is to determine the effects of pregabalin on sleep problems in     patients with seizures.   "
213320|NCT00643149|"     The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and     effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12     hours) when used to treat children with strep throat.   "
213347|NCT00645762|"     This study is designed to evaluate safety and effectiveness of a less invasive procedure to     treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally,     this study will assess the feasibility of performing the procedure under local anesthesia.   "
242129|NCT01025596|"     This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV     infection resistant after 12 weeks of bi-therapy.   "
213304|NCT00642941|"     This study will evaluate the efficacy and safety of R1507 in participants with recurrent or     refractory sarcoma. Eight cohorts of sarcoma participants will be studied in parallel. Cohort     1: Ewing's sarcoma primary cohort defined as participants who have relapsed less than or     equal to (<=) 24 months from diagnosis, received at least two prior chemotherapy programs and     are unresectable. Cohort 2: Ewing's sarcoma non-primary (secondary) cohort defined as     participants who have relapsed greater than or equal to (>=) 24 months from diagnosis or have     only received one prior chemotherapy program. Cohort 3: Expanded Ewing's sarcoma defined as     participants with recurrent or relapse regardless of prior number of salvage regimens and     regardless of time of relapse. Cohort 4: participants with osteosarcoma. Cohort 5:     Participants with synovial sarcoma. Cohort 6: Participants with rhabdomyosarcoma Cohort 7:     Participants with alveolar soft part sarcoma (7a), desmoplastic small round cell tumors (7b),     extraskeletal myxoid chondrosarcoma (7c), clear cell sarcoma (7d), myxoid liposarcoma (7e).     Cohort 8: Participants with unspecified sarcoma diagnosis. Participants in the expanded     Ewing's sarcoma Cohort 3 will receive 27 milligrams (mg)/kilogram (kg) every 3 weeks     intravenously (IV). All other participants will receive R1507 9 mg/kg IV weekly. The     anticipated time on study treatment is until disease progression or unacceptable adverse     events, withdrawal or death.   "
213305|NCT00642954|"     The purpose of this Phase I study of vorinostat in combination with lenalidomide and     dexamethasone in participants with relapsed or refractory multiple myeloma is to determine     the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The safety and     tolerability of the combination regimen will also be evaluated in this study.   "
213306|NCT00642967|"     This single arm study will assess the efficacy and safety of monthly administration of     subcutaneous Mircera when administered for the maintenance of hemoglobin levels in patients     with chronic renal anemia, not on dialysis. Patients currently receiving treatment with     subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of     Mircera, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose     of ESA previously administered. The anticipated time on study treatment is 3-12 months, and     the target sample size is 100-500 individuals.   "
213307|NCT00642980|"     Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an     increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to     reduce the risk of prematurity have not found a statistically significant diminution of risk     (<= 32 wks: OR=0.49 [0.05-5.1], < 37 wks: OR=0.83 [0.59-1.17]).A partial explanation of these     findings is that some of these treatment were administered vaginally, most often during the     second or third trimester      Aim: To reduce the frequency of late abortions and very preterm birth by prescribing     clindamycin vs placebo to patients diagnosed with BV before 13 weeks.   "
217121|NCT00692042|"     The primary aim for this study is to investigate the safety and tolerability of the AZD1704,     first time in man.   "
213308|NCT00642993|"     The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and     overweight participants. The primary measure of effectiveness is the change in body weight     during treatment. Additional measures include waist circumference and body mass index (BMI).     In addition, the safety of SCH 497079 in obese and overweight participants will be evaluated.     The primary hypothesis is that treatment with SCH 497079 will be more efficacious than that     with placebo with respect to the primary efficacy variable.   "
213309|NCT00643006|"     The study aims to compare low-intensive and high-intensive physical exercise and its impact     on physical function, pain and signs of inflammation.   "
213310|NCT00643019|"     This trial randomizes young Mexican American and African American women with a sexually     transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus     control with the goal of preventing recurrent sexually transmitted infections.   "
213311|NCT00643032|"     We wish to study which method of local injection of analgesic (before or during surgery) is     the more effective method to reduce post-operative pain in children. In addition, we wish to     study which pre-operative educational intervention is more effective in reducing anxiety in     children and their family.   "
213312|NCT00643045|"     To evaluate the safety and efficacy of two dose ranges of safinamide (High Dose: 150 to 200     mg/day and Low Dose: 50 to 100 mg/day) orally, as compared to Placebo, as add-on therapy in     patients with early idiopathic Parkinson's disease who are currently receiving a stable dose     of a single dopamine agonist. It is hypothesized that, over a 24-week period, add-on     treatment with safinamide will result in greater improvement of motor symptoms in these     patients, compared to treatment with a dopamine agonist alone.   "
213313|NCT00643058|"     The purpose of the study is to determine the role of nitric oxide (NO) in asthma and to     characterize the symptoms associated with inhaled endotoxin (lipopolysaccharide [LPS]) in     normal subjects. In this study, we will determine the effect of inhaled endotoxin on exhaled     NO in healthy African Americans, with and without NOS2 promoter polymorphisms. The protocol     described in this submission will involve the use of NIH Clinical Center Reference Endotoxin     which has been approved by the FDA under IND BB-IND-10035.   "
213314|NCT00643071|"     Patients with severe refractory ulcerative colitis (UC) or those who received placebo in     study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy     will be evaluated.   "
213315|NCT00643084|"     Research Question: Are anastomotic leak and surgical site infection rates equivalent in     patients having laparoscopic bowel resections without bowel preparation vs those having bowel     preparation?      Bowel preparation is a distressing and uncomfortable procedure for patients undergoing     laparoscopic colorectal surgery, and also carries some risk of morbidity due to dehydration,     electrolyte inbalance and possible infectious complications. If it is found that there is no     difference between those patients who have preoperative bowel preps and those who do not have     them, then we can save these patients this additional distress and risk at the time of their     surgery.   "
213316|NCT00643097|"     RATIONALE: Vaccines made from a peptide may help the body build an effective immune response     to kill tumor cells. Colony-stimulating factors, such as GM-CSF, increase the number of white     blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy     after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients     with newly diagnosed glioblastoma multiforme.   "
213317|NCT00643110|"     Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets     without raising blood sugars too much the way that orange juice or glucose tablets sometimes     do.   "
213321|NCT00643162|"     Depression is a common and disabling condition which represents a substantial public health     concern, especially with the aging of the population in general. In fact, one to four percent     of the older population has major depression. Although medication is the main treatment for     depression, studies show that only 50% of patients show a significant response to treatment.     The response might actually be less in older subjects, and with more adverse side effects due     to changes in the metabolism of the older population as well as drug interaction. For these     reasons (changes in metabolism and possible drug interactions) the starting dose of the     antidepressant Lexapro will be 5mg, instead of 10mg.      To combat the incomplete response to medication, many combined and augmentation strategies     have been developed. Examples of this would be an antidepressant medication plus a     neuroleptic medication; or an antidepressant medication plus talk therapy. One non-medication     treatment that is being considered is massage therapy. Recent data suggest that massage     therapy can be useful for the treatment of depression.      This study proposes to perform a controlled trail to assess the effects of massage therapy on     symptoms of depression in older subjects with major depression. All of the subjects will     receive Lexapro, which is an FDA approved medication for the treatment of depression. Half of     the subjects will receive Swedish massage for one hour, twice a week, and the other half will     receive light touch for one hour, twice per week for eight weeks. Standardized rating scales     that evaluate depression will be used to evaluate the subjects mood.   "
213322|NCT00643175|"     Osteoporosis has been called a silent epidemic whose prevalence is increasing. It often     presents as a fragility fracture, with hospitalizations resulting from minimally traumatic     hip fractures. While the fractures are treated appropriately, the underlying pathology is     often ignored. Numerous studies have shown that prior fracture increases the risk for further     fracture. In 2004 the Surgeon General released a report on osteoporosis, the details of which     include multi-disciplinary treatment of osteoporotic fractures. Treatment of osteoporosis     after hip fracture is also being targeted as a future hospital quality assessment measure.     Hospitals which have no plan in place to address osteoporosis treatment after hip fracture     may be cited, and may have medicare money withheld. The goal of the study is to create an     automated in-patient endocrinology consultation for osteoporotic hip fractures. We plan to     gather patient data in a prospective manner including the endocrinologist recommendations,     adherence to medical therapy after discharge, and future fracture rates. Possible planned     interventions include only appropriate medical therapy for osteoporosis, DEXA bone scanning,     and regularly scheduled telephone follow-up.   "
213323|NCT00645450|"     OBJECTIVE: In the first of two preliminary studies, we demonstrated in individuals with     chronic PTSD that a single (combined 40 mg short- and 60 mg long-acting) 24-hour oral dose of     propranolol, compared to placebo, given immediately following reactivation of the     PTSD-related memory of the traumatic event, significantly reduced physiological responses     during script-driven imagery of that event measured one week later. These results support     blockade of reconsolidation of the traumatic memory, a process that is entirely distinct from     extinction. In addition, we found a trend for post-reactivation propranolol to reduce     self-reported PTSD symptoms, measured via the Impact of Event Scale-Revised (IES-R). In the     second preliminary study, we performed 6 weekly treatments that consisted of the subject     describing their PTSD-related traumatic events for approximately 10 minutes followed by 0.67     mg/kg (minimum 40 mg) short-acting propranolol plus 1 mg/kg (minimum 60 mg) long-acting     propranolol. The mean Clinician Administered PTSD Scale (CAPS) Total Score following the six     treatment sessions was reduced by 44% (p=.02). The proposed work will examine whether     repeated treatments may succeed in producing more substantive symptomatic improvement.      RESEARCH PLAN: The study design will be a randomized, double-blind, placebo-controlled,     clinical trial. A crossover design is not being proposed because the effect is expected to be     neither short-term nor reversible. Rather, at the conclusion of the formal study period,     individuals randomized to the placebo condition will be offered an equal number of treatment     sessions with propranolol. A placebo control will be used, rather than an active treatment     control, because the proposed study will be a proof of concept test of post-reactivation     pharmacological reduction of traumatic memories. The control (and active) treatments will be     structured so as to minimize the chance of extinction. We recognize that eventually this new     treatment will need to be tested against established PTSD treatments, including exposure, if     its clinical utility is to be established. We regard this as a matter for subsequent studies     should the present study yield promising results. However, we do intend to compare the effect     size we find for the proposed intervention with published effect sizes for other PTSD     psychotherapies.      METHODOLOGY: Participants will include male and female combat veterans of the Afghanistan and     Iraqi wars meeting DSM-IV criteria for chronic PTSD, recruited locally from the Manchester     VAMC Mental Hygiene Clinic or through advertising. The presence of PTSD will be assessed     using the CAPS. Participants will be randomly assigned to the propranolol or placebo drug     condition. During each of six memory reactivation sessions, the participant will meet with a     psychiatrist, who will ask the participant to spend ten minutes describing the event that     caused their PTSD, and their reactions to it. The interviewer will facilitate this process by     asking questions, keeping the participant focused on the traumatic event and encouraging     him/her to identify aspects of the traumatic event that continue to provoke emotional     distress. The traumatic memory reactivation will be immediately followed by administration of     propranolol or placebo. Following the six treatment sessions, script-driven imagery will be     used to assess HR, SC, and facial EMG responses to recollections of the traumatic event and     PTSD symptoms will be assessed using the CAPS. A previously developed discriminant function     will be used to classify each person as a physiologic responder or non-responder. There     will also be a 6-month follow-up assessment.      CLINICAL RELEVANCE: The mechanism of memory reconsolidation offers the possibility that     cellular plasticity can be capitalized on to reverse the neuroanatomical and     neurophysiological underpinnings of traumatic memories. The possibility that a traumatic     memory could be significantly weakened by an intervention as simple as the post-reactivation     administration of a widely used and safe medication has profound implications for the     treatment of PTSD.   "
215308|NCT00668473|"     We propose to examine several angiogenic/angiostatic mediators in the skin and serum of     subjects with SSc and compare it to levels found in the skin and serum of healthy subjects.   "
213324|NCT00645463|"     A recently completed clinical drug interaction study of CP-945,598 with ketoconazole, a     potent CYP3A inhibitor, showed that coadministration of CP-945,598 with ketoconazole results     in an approximately 5-fold increase in CP-945,598 total exposure (AUC) and 4-fold increase in     Cmax. Therefore, the sensitivity of CP-945,598 pharmacokinetics (PK) to less potent CYP3A     inhibitors needs to be characterized to support labeling and registration.      Diltiazem is a known substrate and moderate mechanism-based inhibitor of the CYP3A enzyme     system and was chosen as the moderate CYP3A inhibitor for this study as it is a clinically     relevant medication likely to be prescribed concomitantly with CP-945,598 given the increased     risk of hypertension and cardiovascular disease in the obese patient population.   "
213325|NCT00645476|"     Memantine is a glutamate NMDA receptor antagonist which has shown efficacy in cognitive     dysfunction due to moderate to severe Alzheimer disease (Reisberg et al., 2003).      The investigators propose to treat 75 subjects with bipolar disorder with minimal mood     symptoms and cognitive dysfunction with memantine or placebo. The 75 subjects will be     enrolled at three sites. The same study will be performed at all three sites, with each site     functioning independently of the other.      The investigators study will include objective neuropsychological testing of memory and     executive functions before and after treatment, as well as ratings of mood symptoms and     subjective patient ratings of memory function at every study visit.      The principal aim of this study is to measure the efficacy of memantine on improving memory     function in minimally symptomatic subjects with bipolar disorder. The investigators     hypothesize that in minimally symptomatic subjects with bipolar disorder memantine will be     efficacious in improving cognitive functions, as measured by the difference in     neuropsychological test scores at the beginning and at the end of the trial.      Secondary analyses will test the role of memantine in improving residual mood symptoms     (depression and mania) in subjects with bipolar disorder.      Demonstrating the role of memantine in reducing cognitive dysfunction in minimally     symptomatic subjects with bipolar disorder promises to provide important clinical     information, which could lead to improvements in well-being and functional status for large     populations of subjects with bipolar disorder.      There will be an optional open label 12-week extension to the study. Subjects will be     restarted on memantine similar to the regimen in the first phase of the study. Subjects will     meet with the investigators every four weeks (weeks 16, 20, and 24) for assessment as     mentioned above. Neuropsychological testing will be repeated at week 24. It is the     investigator's belief that this added timeline will better demonstrate any improvements in     cognitive function.   "
213326|NCT00645489|"     This is a pilot study of a family-based educational program for patients with heart failure,     and their family members.   "
213327|NCT00645502|"     The primary objective of this study is to demonstrate the bioequivalence, with respect to     risperidone and its active moiety, of a single oral dose of risperidone given as a 4 mg     orally-disintegrating tablet and as a 4 mg conventional RISPERDAL tablet. In addition, their     tolerability and safety will be documented.   "
213328|NCT00645515|"     The purpose of this study is to compare the safety of ziprasidone and risperidone for the     treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of     ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to     compare their tolerability and efficacy.   "
213329|NCT00645528|"     The purpose of this research is to determine if meeting in a group with other subjects with     diabetes can reduce barriers to starting insulin.   "
213330|NCT00645541|"     Primary Objectives:        -  To determine the feasibility of axillary reverse mapping (ARM) in patients undergoing          axillary lymph node dissection for breast cancer therapy.        -  To determine the incidence of breast cancer metastasis in lymph nodes draining in the          arm as identified by axillary reverse mapping.        -  To determine the safety of axillary reverse mapping.   "
213331|NCT00645554|"     The purpose of this open-label, single dose, two-treatment, two-period, cross-over study is     to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and     galantamine tablet.   "
213332|NCT00645567|"     This is a laboratory-based study to evaluate the risk of shoulder injury associated with     transfers between wheelchair and vehicle in persons with spinal cord injury. Four new devices     will be compared against an unassisted transfer.   "
213344|NCT00645723|"     Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus     inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline     solution in patients with VAP due to baumannii carbapenems resistant.   "
213333|NCT00645580|"     In our study we aim to examine the effect of SSRI augmentation on negative symptoms and     cognitive function in schizophrenia patients as well as to examine the effect of SSRI     augmentation on the RNA and protein products in peripheral mononuclear cells (PMC). Finally,     we aim to relate changes in PMC elements to changes in clinical symptoms and cognitive     function. Our study hypotheses are that SSRI augmentation of anti-psychotic treatment in     schizophrenia patients will improve negative symptoms as well as cognitive symptoms and that     this improvement will be related to biochemical changes identifiable in PMC elements.   "
213334|NCT00645593|"     This study will compare the effects, good and/or bad, of chemotherapy (Gemcitabine and     Cisplatin) with or without the addition of the chemotherapy drug Cetuximab to find out which     treatment is better.   "
213335|NCT00645606|"     RATIONALE: Classical chemotherapy does not cure advanced chronic lymphocytic leukemia (CLL)     despite new drugs. Rituximab is a monoclonal antibody directed against CD20 surface antigen     on B lymphocytes and leads to apoptosis of CD20 positive B lymphocytes. The highest response     rate yet published in the treatment of first-line CLL has been obtained by the association of     fludarabine, cyclophosphamide and rituximab (FCR). Now, the question is whether this response     can be improved, as some trials showed that eradication of minimal residual disease (MRD) in     CLL is associated with a longer treatment-free and overall survival. Maintenance therapy     using rituximab has been recently approved as a means of prolonging remission in patients     with indolent non Hodgkin's lymphoma. Maintenance therapy with rituximab could be of interest     in treatment of MRD in CLL and prolonging remission and survival times.      PURPOSE: The overall purpose of the study is to determine the value of immunotherapy     maintenance with single agent rituximab in comparison with no further treatment (observation     ) for previously untreated chronic lymphocytic leukaemia in elderly (>65 years) patients who     respond to induction immunochemotherapy with FCR.   "
213336|NCT00645619|"     The purpose of this study is to determine whether a protein called TREM-1 can be used to     differentiate viral and bacterial pneumonias in children who are on ventilator support. We     propose that the level of TREM-1 will be significantly elevated in the lung fluid of children     with bacterial pneumonia and viral with co-existing bacterial pneumonia than in children with     pure viral pneumonia.   "
213354|NCT00645853|"     The purpose of this study is to provide safety and tolerability data for AZD0837 during     long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one     or more additional risk factors for stroke and systemic embolic events (moderate to high risk     patients).   "
217122|NCT00692055|"     We will evaluate the bioavailability of naproxen 375 mg in two formulations   "
213337|NCT00645632|"     RATIONALE: Drugs used in chemotherapy, such as ifosfamide, methotrexate, cisplatin, and     doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving chemotherapy before surgery may make the     tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it     after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating     patients undergoing surgery for newly diagnosed high-grade osteosarcoma.   "
213338|NCT00645645|"     A study of the complex genetics of brain development will be undertaken with an emphasis on     those genes that cause the most common structural brain anomaly in humans called     holoprosencephaly (HPE). This malformation of the brain can result from either environmental     or genetic causes, and it is the aim of these investigations to determine the genes     responsible for both normal and abnormal brain development through the study of patients with     this disorder. Mutations in one such gene, Sonic Hedgehog, have been shown by us to be     responsible for approximately one quarter of familial cases of HPE. Other genes either     related to the hedgehog pathway or located at unrelated defined genetic loci may also     contribute to HPE and are the subject of active investigation. We anticipate that many genes     important for normal brain development will be identified in the search for genetic causes of     HPE.   "
213339|NCT00645658|"     Muscle wasting is common in advanced chronic kidney disease (CKD) and adversely affects     morbidity and mortality. In 2/3 of males with advanced CKD serum testosterone (TT) levels are     reduced, and likely contributes to the wasting. As TT in relatively safe physiologic     replacement doses, increases muscle mass in otherwise normal TT deficient subjects, we     hypothesize that physiologic TT replacement will be effective in preventing and treating the     loss of muscle mass and function in CKD patients, will improve quality of life and may reduce     some cardiovascular disease (CVD) risk factors.   "
213340|NCT00645671|"     To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment,     0.5% vs. vehicle for the treatment of inflammation following cataract surgery   "
213341|NCT00645684|"     The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal     surgery as part of a controlled randomized single blinded parallel group trial. The     applicability and safety of the strand material used in two suture techniques (2-layer suture     technique vs. 1-layer running) are to be tested on the basis of handling characteristics, the     operative time consumed for the construction of the 1st anastomosis, the average time of the     hospital duration for both patient groups, and the frequency of postoperative complications     after discharge, 1 month and a maximum of 3-4 months. The used suture units are counted and     the length of sutures determined which will be an indirect measurement of the costs of suture     material for the two techniques.   "
213342|NCT00645697|"     One complication of uveitis which is driven by an increase in VEGF is the formation of     inflammatory ocular neovascularization (ION). Here, we analyze the therapeutic role of     intravitreal bevacizumab in ION not responding to standard therapy (systemic and ocular     corticosteroids and systemic immunosuppressants) in a multicenter retrospective study.The     natural history of subfoveal choroidal new vessels histoplasmosis, multifocal choroiditis,     Harada and other inflammatory chorioretinal disorders has been very guarded, but with this     new approach, we hope to stop the visual loss in these relatively young patients.   "
213343|NCT00645710|"     RATIONALE: Drugs used in chemotherapy, such as floxuridine and gemcitabine hydrochloride,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Hepatic arterial infusion uses a catheter to carry     cancer-killing substances directly into the liver. Radiolabeled monoclonal antibodies can     find tumor cells and carry tumor-killing substances to them without harming normal cells.     Giving hepatic arterial infusion of floxuridine together with gemcitabine hydrochloride and     radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain     after surgery.      PURPOSE: This phase I/II trial is studying the side effects and best dose of floxuridine when     given as a hepatic arterial infusion together with gemcitabine hydrochloride and radiolabeled     monoclonal antibody therapy and to see how well it works in treating liver metastases in     patients with metastatic colorectal cancer.   "
213350|NCT00645801|"     The primary objective is to compare the effectiveness and tolerance of Amitiza®     (lubiprostone) plus GoLYTELY® (polyethylene glycol-electrolyte solution) versus placebo and     GoLYTELY ® (polyethylene glycol-electrolyte solution) as a bowel cleansing preparation for     colonoscopy.   "
213351|NCT00645814|"     Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic     Plaque Psoriasis   "
213352|NCT00645827|"     Insulin infusions are commonly used in hospitalized diabetics to control blood sugar, and     they are effective. However, insulin infusions require the use of limited resources. Insulin     infusions are therefore changed to insulin shots as a patient recovers. Once an insulin     infusion is stopped and shots are started, blood sugar control is harder to maintain. This     is, in part, because physicians have different ideas on how to dose insulin shots in     hospitalized patients. A math equation has been developed by the research staff that attempts     to predict the effective doses of insulin shots in patients whose insulin infusion have just     been stopped. The math equation was developed for patients with type 2 diabetes mellitus. In     this study, all patients will be treated with the same type of insulin shots, with doses of     the insulin shots chosen either by the math equation or by the judgment of the patient's     physician. The study will then follow blood sugar values for 24 hours to see if the math     equation is effective. If the equation is proven to be effective, a new tool will exist for     physicians to determine the best dose of insulin shots for type 2 diabetics. Such a tool     would, in turn, allow for widespread use of insulin infusions to determine a patient's     insulin needs before discharge from the hospital. Blood sugar control for type 2 diabetics     that are inpatient or outpatient would improve as a result, with potentially far reaching     public health benefits.   "
213353|NCT00645840|"     The purpose of this study is to determine whether control of inflammatory pathways mediated     by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in     expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in     children with newly diagnosed type 1 diabetes. Ultimately, we believe that control of IL-1     beta pathways will be associated with preserved insulin secretory capacity.   "
213355|NCT00645866|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin, docetaxel, and capecitabine, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving epirubicin together with     docetaxel and capecitabine and to see how well it works in treating women with stage IIIA or     stage IIIB breast cancer.   "
213356|NCT00645879|"     The objective of this project is to define whether nutritional supplements (ornithine     alpha-ketoglutarate, glutamine, or citrate) capable of filling-up the citric acid cycle     (anaplerotic therapy) can improve hyperammonemia, glutamine levels, and outcome in patients     with propionic acidemia. Ornithine alpha-ketoglutarate, glutamine, and citrate are commonly     used as nutritional supplements specially by athletes to increase muscle strength. They can     be mixed with formula or other foods.   "
213357|NCT00645892|"     Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe     Chronic Plaque Psoriasis   "
213358|NCT00645905|"     Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic     Plaque Psoriasis   "
213359|NCT00645918|"     The objective of the GRAVITAS trial is to determine whether tailored anti-platelet therapy     using the Accumetrics VerifyNow P2Y12 assay reduces major adverse cardiovascular events after     drug-eluting stent implantation.   "
213360|NCT00645931|"     This study is designed to examine the psychological effects of bone marrow transplants on     children and their families. The investigators hypothesis is that families who show signs of     psychological distress before transplant will continue those signs post transplant. The     investigators are examining cognitive placement, emotional placement and other psychological     factors in both the child undergoing transplant and his or her parent.   "
213361|NCT00645944|"     The major goal of this project is to investigate established insomnia treatments in a     schizophrenia population to see if the improved sleep leads to overall better quality of     life. In addition, we hypothesize that the insomnia treatment may also lead to observed     improvements in other symptoms associated with schizophrenia such as cognitive impairments,     obesity, and negative symptoms.   "
213362|NCT00645957|"     All patients presenting to Grady Memorial Hospital with an odontogenic (dental) infection     that requires admission to the hospital and incision and drainage will be eligible for     inclusion in this pilot study. The surgical method used for incision and drainage will be     determined by the attending surgeon who will operate on the patient. The surgical procedure     is a simple and universally standardized involving one or more small incisions in the mouth     or in the upper neck and the placement of a drain(s) within the infected area to facilitate     continued drainage of pus. Subjects will be randomized to either a red rubber or penrose     drain(s). The drains are placed through the mouth or upper neck depending on the location of     the infection and typically remain in place until the drainage has stopped (several days).     All drains are secured with a single stitch through the gum or skin. The drain(s) will be     removed bedside by removing a single suture and gently withdrawing the drain. The timing of     this is determined by the clinical picture although this typically occurs within the first     week. This is not a painful procedure. Currently some surgeons place red rubber drains which,     after placement, allow the infection not only to drain but also be irrigated with saline both     during the surgery and in the immediate post-operative period. Other surgeons place penrose     drains, which, after placement, continue to allow the infection to drain but cannot be     irrigated. Red rubber drains require daily irrigation and as such are labor intensive.     Furthermore, drains that are irrigated may continue to drain the saline irrigant in the many     hours after irrigation that upon clinical inspection may be difficult to distinguish from     sero-sanguinous (pus) drainage. It is daily inspection of the drainage (or lack thereof)     which determines the appropriate time to remove the drain(s). This in turn may influence time     to discharge and ultimately hospital costs   "
213363|NCT00645970|"     We believe information to be obtained from this proposed study will prove critical for     planning future VA healthcare strategies and developing effective and efficient treatments     targeting pain and emotional adjustment difficulties among individuals with polytrauma and     returning Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) personnel. More     specifically, this study will be the first to provide systematic data regarding pain and     emotional problem prevalence, course, associated impairments, risk factors, and barriers to     care and community reintegration among returning OEF and OIF service members with and without     polytrauma.   "
213364|NCT00645983|"     This study will determine the effectiveness of chamomile extract for treating generalized     anxiety disorder.      Study hypotheses: 1)Chamomile extract will have a superior anti-anxiety effect compared to     placebo. 2)Chamomile will have a comparable safety profile to that of placebo.   "
213365|NCT00645996|"     Background: It is well established that the presence of bacteria in the intestine has a     profound influence on health. Probiotics, (beneficial bacteria) have shown ameliorating     effects on various infectious diseases. The influence of probiotics on several     immune-mediated conditions has also been investigated, among them, atopic dermatitis (Asthma     of the skin), and milk allergy.      The precise mechanism of action of probiotics is not fully understood. Several animal and     human studies have shown the probiotic bacteria to influence the immune system. The aim of     the present study is to evaluate whether supplementing the diet with oral probiotics affects     the immune response of children following routine vaccination against 4 common childhood     viral diseases: Mumps, Measles, Rubella and Varicella.      Objective(s) and Hypothesis(es):      Hypothesis: Administration of probiotics will increase the amount of antibodies produced     following vaccination for Measles, Mumps, Rubella and Varicella, by over 15%.      Objectives:        -  To determine whether administration of probiotics during infancy influences antibody          levels following the routine childhood vaccinations.        -  To determine whether administration of probiotics during infancy influences the rate of          adverse effects following the routine childhood vaccinations.      Potential Impact: Vaccines, alongside with the discovery of Penicillin, have been cited as     the great public health successes of the 20th century. However, even in countries with     maximal childhood immunization coverage, the protective effect is not optimal. For example,     only 70% to 90% of children immunized against chickenpox are actually protected against the     disease. If we succeed in raising these numbers, even by a single percent, it will have a     huge impact on society.   "
213366|NCT00646009|"     The purpose of this study is to compare the early onset of effect of Symbicort compared to     Advair Diskus and Ventolin in adults with asthma   "
213385|NCT00646256|"     The aim of the study is to examine whether the efficacy of psychoeducation in patients with     schizophrenia or schizoaffective disorders is dependent on their cognitive performance level     and if a preceding cognitive training can enhance the therapeutic effects of psychoeducation   "
213386|NCT00646269|"     ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact     of cognitive training, reminiscence therapy and a made-to-measure program on the     progression rate of dementia.   "
213367|NCT00646022|"     This study will evaluate members in families with a history of small bowel carcinoid cancer     to study the natural history of those family members that have the disease, determine ways to     improve early detection by performing surveillance on those at risk but without disease and     to identify the gene(s) that may cause the tumors. Familial carcinoid tumors usually     originate in hormone-producing cells that line the small intestine or other cells of the     digestive tract. The tumors are slow-growing and usually take many years before they cause     symptoms. It is known that these tumors occur more often in some families and are then passed     from one generation to the next by inherited genes.      Members of families, including all siblings and offspring in which two or more immediate     blood relatives have had small bowel carcinoid tumors are eligible for this study. In some     cases unaffected spouses of family members diagnosed with carcinoid cancer are also requested     to participate by donating a sample of blood only.      Participants undergo a medical evaluation every 3 years during a 3- to 5-day hospital stay at     the NIH Clinical Center. All participants have a personal and family medical history obtained     and undergo a physical examination, blood and urine tests.      People who already have a small bowel carcinoid tumor or are at risk of developing a     carcinoid tumor have some or all of the following procedures to determine the presence of     carcinoid tumor and its (omit next two words- location or) spread to other areas of the body:        -  Video Capsule Endoscopy: Visualization of the gastrointestinal tract by ingesting a          disposable, vitamin-pill sized video capsule that has its own camera and light source.        -  CT of the chest abdomen and pelvis with oral and IV contrast : X-ray examination of the          chest, abdominal and pelvis organs.        -  18 FDOPA Positron emission tomography (PET) with CT for localization: Nuclear imaging          scan to look at tumor activity.        -  MRI Liver with contrast - to determine if disease has spread to liver        -  Gallium 68 PET/CT-limited to individuals that have residual tumor.        -  Clinical and research blood work      Should mid gut carcinoid tumors be found every participant will be assisted in determine what     the best course of treatment will be for them.   "
213368|NCT00646035|"     To determine the safety and efficacy of paricalcitol capsules as compared to placebo for     treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone     levels in end stage renal disease subjects on peritoneal dialysis.   "
213369|NCT00646048|"     This study was a prospective observational study examined the safety of the TriVascular AAA     Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms.     Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System,     evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired     location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to     exclude the abdominal aortic aneurysm.   "
213370|NCT00646061|"     Renal colic is very common in emergency department patients. Our aim of this study is which     combination of drug is more effective in renal colic.   "
213371|NCT00646074|"     Most individuals with Alzheimer's or dementia return home, where their care is supported by     family and friends. Although family caring at home is usually rewarding, it is often     challenging, too. The demands and responsibilities of caring for a loved one at home can be     stressful. The actual activities of caregiving vary according to the needs of the individual,     but can include helping with bathing, dressing, eating, and many other activities. Caregivers     must learn care techniques and how to manage changes in roles and lifestyle. While adjusting     to these changes, caregivers may be advised to 'take care' of themselves, but may not receive     guidance or support for doing this. In this study, we are testing a self-care intervention     for older, spouse caregivers of persons with Alzheimer's or dementia to see how helpful the     intervention is in reducing distress and in helping caregivers adopt and maintain healthy     lifestyle behaviors.      We have developed an intervention for caregivers that is called Self-Care TALK. The     intervention includes creating a health-promoting, self-care education and support     partnership between caregivers and nurses through the use of weekly telephone conversations.     Each conversation focuses on a health-related topic, such as: healthy habits, building     self-esteem, focusing on the positive, avoiding role overload, communicating, and building     meaning. The conversations follow a basic format, but also are unique to each person.     Participants complete questionnaires before and after the intervention, so that we can test     the effect of participation in Self-Care TALK on caregiver health.      We know that education and support about self-care can be achieved through partnerships     between family caregivers and health care professionals. Our goal is to build on this     knowledge in testing whether participation in the Self-Care TALK intervention will result in     less distress and better health and well-being for spouse caregivers, compared to caregivers     who receive no additional care beyond usual education and support. In working toward this     goal, we are using a partnership approach, in which nurses and caregivers discuss several     health-related topics and mutually identify creative solutions for caregivers to incorporate     self-care and health-promotion strategies into their daily routines. Promoting healthy     outcomes for caregivers is essential to supporting their personal well-being, and to     fostering their ability to continue home care for their loved one.   "
213372|NCT00646087|"     Depression is a wide spread illness. Depression contributes most significantly to national     health care costs. While the number and types of treatments used for depression have expanded     over the years, even with an increased range of options, the response rate, defined as the     number of subjects who have a 50% reduction in depressive symptoms, is estimated to be around     65%.      This randomized clinical trial will examine the frequency of treatment with ketamine in     patients with treatment-resistant depression TRD without psychosis. It will compare two modes     of the ketamine treatment; every other day ketamine, versus two active and four placebo     treatments over the period of 12 days.   "
213644|NCT00640237|"     The purpose of the study is to examine the vitamin D state of elder patients in therapeutic     departments and to compere the treatment during the hospitalization with the out-patient     treatment.   "
213373|NCT00646100|"     Transcatheter arterial chemoembolization (TACE) had been proved to improve the survivals for     middle stage hepatocellular carcinoma (HCC), but for advanced stage HCC its' efficacy had not     been proved. The investigators hypothesize that TACE also improve the survivals for advanced     stage HCC. Thus, the investigators carried out this prospective control study to find out if     the survivals for patients after TACE better than only best support or not.   "
213374|NCT00646113|"     To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant     when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary     hypothesis is that implant survival after 5 years is equal to what has been observed with     comparable implants in current literature.   "
213375|NCT00646126|"     The malaria parasite Plasmodium falciparum remains at sub-patent level throughout the dry     season in areas of seasonal malaria transmission. Targeting this parasite reservoir before     the transmission season could be a good strategy for malaria control. We are conducting a     randomized double blind placebo controlled mass drug administration trial in eight village to     clear the dry season low level parasitaemia with an ultimate aim of controlling malaria in     eastern Sudan.   "
213376|NCT00646139|"     RATIONALE: KX2-391 may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of KX2-391 in treating     patients with advanced solid tumors or lymphoma that did not respond to treatment.   "
213395|NCT00646386|"     Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody     Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis   "
213396|NCT00646399|"     Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing     staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior     to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study     days 0, 1, 2, 9, 16, and 23.   "
213377|NCT00646152|"     This study will examine the safety of an experimental medication called Poly-ICLC, developed     for preventing or reducing the severity of infections from influenza and other viruses     acquired through the nose, mouth and lungs. The study is divided into two parts, in which     Poly-ICLC is tested at different dose levels.      Healthy people between 18 and 70 years of age who have no chronic medical problems may be     eligible for this study. Participants undergo the following procedures:      Part I        -  Up to 7 days before Poly-ICLC administration: Medical history, physical examination and          blood tests.        -  Day 1: Nasal wash and Poly-ICLC administration. A small amount of salt water is placed          into the front of the nose and then suctioned out. Poly-ICLC is then squirted into each          nostril, one after the other, at a dose of 0.25, 0.5 or 1 mg. A small number of subjects          are given a placebo (a solution with no active ingredient.) Subjects are observed in the          clinic for 30 minutes after treatment.        -  Day 2: Subjects receive a second nasal wash and repeat blood tests. They keep a diary          card for 1 week, recording any drug side effects.        -  Day 5: Subjects have repeat blood tests and a review of their diary card. The keep a          diary card for another 3 weeks.        -  Day 12: Subjects are contacted by phone to review their diary card.        -  Day 28: Subjects are contacted by phone to review their diary card.      Part II        -  Up to 7 days before Poly-ICLC administration: Medical history, physical examination and          blood tests.        -  Day 1: Nasal wash and Poly-ICLC administration. Same as above for Part I participants.        -  Day 3: Subjects receive a second dose of medication and are observed again for 30          minutes.        -  Day 4: Subjects receive a second nasal wash and repeat blood tests. They keep a diary          card for 1 week, recording any drug side effects.        -  Day 7: Subjects have repeat blood tests and a review of their diary card. The keep a          diary card for another 3 weeks.        -  Day 14: Subjects are contacted by phone to review their diary card.        -  Day 28: Subjects are contacted by phone to review their diary card.   "
213378|NCT00646165|"     To determine the dose and duration of treatment for the best overall response with Forodesine     in relapsed B-cell chronic lymphocytic leukemia   "
213379|NCT00646178|"     Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to     Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying     anti-Rheumatic Drug Therapy   "
213380|NCT00646191|"     Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic     Plaque Psoriasis   "
213381|NCT00646204|"     To evaluate the effects of Memantine on non-motor symptoms in patients with Parkinson's     disease.      Parkinson's disease (PD) affects about one million people in the United States. It is a     common neurological condition that is clinically defined by rigidity (muscle stiffness),     bradykinesia (slowness of movement) and tremor. Parkinson's Disease , however, reveals     numerous non-motor symptoms that have been underemphasized. Problematic symptoms include     varying degrees of dementia, psychosis, diminished assertiveness and confidence, general     fatigue, excessive daytime sleepiness, problems with blood pressure, sweating, and bladder,     and a common yet difficult to define sense of not feeling well.   "
213382|NCT00646217|"     Most stroke survivors return home, where their care is supported by family and friends.     Although family caring at home is usually rewarding, it is often challenging, too. The     demands and responsibilities of caring for a loved one at home can be stressful. The actual     activities of caregiving vary according to the needs of the stroke survivor, but can include     helping with bathing, dressing, eating, and many other activities. Caregivers must learn care     techniques and how to manage changes in roles and lifestyle. While adjusting to these     changes, caregivers may be advised to 'take care' of themselves, but may not receive guidance     or support for doing this. In this study, we are testing a self-care intervention for older,     spouse caregivers of persons with stroke to see how helpful the intervention is in reducing     distress and in helping caregivers adopt and maintain healthy lifestyle behaviors.      We have developed an intervention for caregivers that is called Self-Care TALK. The     intervention includes creating a health-promoting, self-care education and support     partnership between caregivers and nurses through the use of weekly telephone conversations.     Each conversation focuses on a health-related topic, such as: healthy habits, building     self-esteem, focusing on the positive, avoiding role overload, communicating, and building     meaning. The conversations follow a basic format, but also are unique to each person.     Participants complete questionnaires before and after the intervention, so that we can test     the effect of participation in Self-Care TALK on caregiver health.      We know that education and support about self-care can be achieved through partnerships     between family caregivers and health care professionals. Our goal is to build on this     knowledge in testing whether participation in the Self-Care TALK intervention will result in     less distress and better health and well-being for spouse caregivers, compared to caregivers     who receive no additional care beyond usual education and support. In working toward this     goal, we are using a partnership approach, in which nurses and caregivers discuss several     health-related topics and mutually identify creative solutions for caregivers to incorporate     self-care and health-promotion strategies into their daily routines. Promoting healthy     outcomes for caregivers is essential to supporting their personal well-being, and to     fostering their ability to continue home care for their loved one.   "
213383|NCT00646230|"     RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I trial is studying the side effects and best dose of intravenous     fenretinide in treating young patients with recurrent or resistant neuroblastoma.   "
213402|NCT00646477|"     The study is a prospective field evaluation to assess the therapeutic value of the     CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.      Precisely, the study was designed to :        -  evaluate the therapeutic efficacy of the CPAP/autoCPAP Sandman device in improving sleep          quality and normalozing respiratory events        -  determine the sensitivity and specificity of the device in adequately detecting          respiratroy events        -  compare effective pressure Peff determined by the device and during manual titration        -  compare the impact of the two-speed descent pressure algorithm   "
213434|NCT00646893|"     The objective of this study is to demonstrate that Preimplantation Genetic diagnosis will     significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients     of advanced maternal age (37-42) undergoing IVF. We would like to test this hypothesis by a     randomized trial performed with the most suitable conditions using very successful IVF     laboratories capable to perform the embryo biopsy under strict controlled conditions after     proper training and validation of the techniques.   "
215132|NCT00666354|"     The purpose of this clinical study is to compare the efficacy and safety of three     concentrations of topical methotrexate for the treatment of fingernail psoriasis.   "
213384|NCT00646243|"     Background. Clinical benefits of cardiac resynchronization therapy (CRT) have been clearly     demonstrated in heart failure (HF) patients with severe left ventricular (LV) dysfunction and     wide QRS at surface electrocardiogram. However, there is a growing evidence that QRS duration     poorly predicts responses to CRT, and that ~30% of patients do not experience any benefit     from CRT when pre-implant dyssynchrony is defined according to electrocardiographic criteria.     A number of echocardiographic criteria have been proposed to assess mechanical LV     dyssynchrony, but at present there is no consensus on their use to predict response to CRT.      Study Design. The Italian Multicenter PROject on echo assessment of left VEntricular     (IMPROVE) dyssynchrony study is a prospective, multicenter, observational study aimed to     assess feasibility and predictive power of mechanical dyssynchrony assessed by     echocardiography in consecutive consenting patients candidate to CRT by clinical and     electrocardiographic criteria. IMPROVE will enroll 120 healthy subjects and 216 HF patients     in 6 sites in Italy. CRT response criteria will be based on improvement in NYHA class and LV     reverse remodeling evaluated by 3D-echocardiography. Enrollment is expected to conclude early     2009.      Implications. CRT is today part of the therapeutic armamentarium for symptomatic HF patients     refractory to medical therapy, with wide QRS complex and severe LV systolic dysfunction. The     IMPROVE study has been designed to evaluate reference values of indexes of ultrasound     mechanical dyssynchrony that have been proposed in the literature and compare their ability     to predict response to CRT in HF patients.   "
213387|NCT00646282|"     Patients with kidney failure on dialysis can be successfully transplanted. However, many of     them do not attain a normal kidney function and/or present a slow deterioration of kidney     function after transplantation. As a consequence, they can develop an endocrine disorder     called hyperparathyroidism, which can cause bone disease and a high risk of bone fractures.     In spite of the known bone disease and hyperparathyroidism, there is no well defined     treatment for these patients.      Moreover, kidney transplant recipients present a higher mortality rate compared to the     general population, and the principal cause of death is cardiovascular disease. Dialysis     patients are known to have extensive cardiovascular calcifications and increased vascular     stiffness, and these factors have been closely associated with cardiovascular mortality.      The effect of vitamin D on bone health is well known in the general population. Many studies     showed a reduction in fracture rate in post-menopausal women and older men receiving vitamin     D and calcium supplements. Vitamin D analogues are also commonly used to treat     hyperparathyroidism in dialysis patients. Finally, vitamin D has been suggested to have     beneficial effects on the cardiovascular system and to reduce mortality in dialysis patients.      Hectorol® is a vitamin D analog which has been demonstrated to effectively treat     hyperparathyroidism in dialysis and pre-dialysis patients.      The effects of vitamin D supplementation on bone disease, hyperparathyroidism and     cardiovascular function in kidney transplant recipients have not been properly studied.      Whether Hectorol® therapy helps reducing the severity of bone disease and improving vascular     function in kidney transplant recipients is still unknown.   "
213388|NCT00646295|"     Thyroid related orbitopathy (TRO) is an autoimmune disease. Clinical features include:     orbital pressure pain, ocular soft tissue swelling, muscle enlargement around the eyeball,     eyelid retraction and bulging of the eye anteriorly out of the orbit. In many cases, the     cornea may become too dry, and as a result, corneal ulcers may form, which can become     infected. In severe cases, damage to the optic nerve can occur secondary to optic nerve     compression by enlarged muscles in the orbit.      Inflammation with soft tissue swelling occurs in the 1st stage of the disease. Scar formation     can occur in the 2nd phase. The muscles under and nasal to the eyeball are most commonly     involved. In many patients, intra-ocular pressure (IOP) can increase in primary. IOP in     upgaze (when looking up) can increase.      Goldmann applanation is the standard device to measure the IOP. It measures the average IOP     (between the systolic, when the heart contracts, to the diastolic IOP, when the heart     relaxes). Pascal Dynamic Contour Tonometer is a new device that can measure IOP and ocular     pulse amplitude (OPA) which is the difference between diastolic IOP and systolic IOP. The     choroid is a vascular layer inside the eyeball that feeds part of the retina (the retina is     like the film in a non-digital camera). OPA is suggestive of choroidal blood flow. IOP     measurements using Pascal Dynamic Contour Tonometer are less influenced by corneal thickness     as opposed to Goldmann applanation which measures higher values in thicker corneas. In the     current study we are interested in measuring the relationships between measurements taken     with Goldmann applanation (IOP) and those taken with the Pascal Dynamic Contour Tonometer     (IOP and OPA). In addition, we will investigate the effect of orbital muscle enlargement on     IOP/OPA following an up gaze position (looking up).   "
213389|NCT00646308|"     The purpose of this study is to determine if patients with a history of nonsecreting     pituitary adenomas with untreated GH deﬁcient patients have proﬁles consistent with increased     cardiovascular risk compared to patients without GH deficiency who have undergone similar     surgery.   "
213390|NCT00646321|"     The purpose of this study is to compare Symbicort with budesonide alone for the treatment of     asthma in children aged 6 to 15 years   "
213391|NCT00646334|"     Optilene® Mesh Elastic and Ultrapro® Mesh will be used for incisional hernia repair. The     primary objective of this clinical study is to demonstrate that Optilene® Mesh Elastic is     superior to Ultrapro® Mesh in incisional hernia repair in matter of the physical function     score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include     the patient's daily activity, the rating of patients pain and the wound assessment determined     on several occasions during the six months observation time.   "
213392|NCT00646347|"     The implementation of Neuro Hand Orthosis Upper Limb Program can significantly improve the     severe stroke paralytic arm in subacute rehabilitation as compared with the use of     conventional therapy.   "
213432|NCT00646867|"     To determine if Tetrix Cream, when applied to the skin lesions on patients with contact     dermatitis, improves the symptoms of burning and itching.   "
213393|NCT00646360|"     Our research is about the significance of polyunsaturated fatty acids (PUFAs) for human     development. Specifically, we will assess the effect of docosahexanoic acid (DHA)     supplementation during pregnancy on infant growth and development through a randomized     controlled intervention trial in Cuernavaca, Mexico. This is a collaborative effort between     the Rollins School of Public Health, Emory University, the Instituto Nacional de Salud     Publica (INSP) and the Instituto Mexicano del Seguro Social (IMSS), Cuernavaca, Mexico.     Pregnant women attending the IMSS General Hospital I are recruited between 18-22 wks     gestation and assigned randomly to receive either DHA (400 mg) or a placebo daily until     delivery. The main study outcomes include a) birth outcomes: birth size, gestational age,     cord blood levels of DHA and neurodevelopment b) maternal blood and breast milk DHA levels at     1 and 3 mo post-partum) c) postnatal growth and development during the first 5 years of age     and d) infant DHA status at 3, 12 and 18 mo. All data collection is carried out at the study     headquarters (IMSS) except for home environment that is assessed during home visits. Physical     growth (length, weight, and head circumference) and infant and child development (visual and     auditory evoked potentials, visual attention, Bayley scales of infant development, McCarthy     child development score, Hearts and Flowers stroop test, and other computerized child     development tests) are measured at birth, 1, 3, 6, 9, 12, 18, 24, 36 mo and at 4 and 5 years     of age by trained workers. Data are also obtained on socioeconomic status, obstetric history,     maternal diet, anthropometry and intelligence, quality of home environment and infant feeding     practices. Data analysis will include group comparisons (intent-to-treat) after ensuring     effectiveness of randomization, and structural equation modeling to examine the various     pathways by which DHA supplementation during pregnancy affects child growth and development.     The findings of this project will contribute significantly to our understanding of the     functional consequences of DHA supplementation during pregnancy.   "
213394|NCT00646373|"     The objective of this study is to evaluate the impact of reduced pump prime on blood     transfusions and postoperative complications in patients at high risk of severe hemodilution     during CPB.      HYPOTHESIS The use of a new CPB circuit with a smaller internal volume, together with     retrograde autologous priming of the lines (RAP) will allow a smaller prime volume and     therefore less significant hemodilution on pump.      EXPERIMENTAL DESIGN Overview      Patients will be randomized on the morning of surgery to one of the two study groups in a 1:1     allocation scheme:        1. Low pump prime        2. Standard pump prime Outcomes The primary outcome is the number of units of blood          products transfused within the first 24 hours post CPB.   "
213399|NCT00646438|"     Standard care for patients with diabetes having CABG surgery at Providence St. Vincent     Medical Center includes strict control of blood sugar (glucose) levels for 3 days after     surgery. This is done through frequent monitoring of blood sugar levels and by giving insulin     continuously through a needle into a vein (intravenously). This intensive glucose control has     resulted in fewer complications such as serious infections and death, and has shortened the     length of the hospital stay for patients.      This study treatment is different from standard treatment in that it extends the intensive     glucose control beyond the third postoperative day to one full year. Once discharged from the     hospital following the CABG procedure, the intense glucose control is done using subcutaneous     insulin (a shot under the skin), oral medications, and by measuring blood sugar levels     frequently.      The purpose of this study is to see how safe and effective strict glucose control is when     extended beyond 3 days and hospital discharge for one year. Another purpose is to see how     well patients can comply with the daily management of intensive glucose control for one-year     as well as the study follow-up schedule.   "
213400|NCT00646451|"     Pregabalin is approved for the treatment of nerve pain as well as an additional therapy in     the treatment of seizures. In December 2004, Pfizer gained Food and Drug Administration (FDA)     approval for use of pregabalin in nerve pain associated with diabetes and shingles; making it     the first FDA-approved treatment for both of these nerve pain states.      Tremor is uncontrolled trembling in part of the body. Essential tremor (ET) is associated     with purposeful movement(e.g., holding a glass to drink, shaving, writing and buttoning a     shirt). It occurs most often in the hands and head and also may affect the arms, voice box     (larynx), trunk, and legs. ET is caused by abnormalities in areas of the brain that control     movement. It usually does not result in serious complications.      ET affects approximately 5 million people in the United States. Incidence is highest in     people over the age of 60.      ET usually develops gradually during middle age or later in life. Symptoms may remain mild or     become more severe over time. Stress, fatigue, anxiety, and hot or cold weather can worsen     the disorder. Severe tremor may cause difficulty doing activities of daily living, such as:        -  Brushing hair and teeth        -  Holding a glass without spilling        -  Performing self-care (e.g., getting dressed, shaving, putting on makeup)        -  Using eating utensils        -  Writing and drawing      The purpose of this study is to examine the tolerability and efficacy of Pregabalin in     patients with ET .      In other words, can patients diagnosed with ET tolerate high dose of pregabalin? Will the     pregabalin be considered as an efficient medicine in the treatment of ET?   "
213401|NCT00646464|"     Computerized continuous performance tests (CPT) considered the gold standard for diagnosis     of Attention Deficit/Hyperactivity Disorder (ADHD.      This type of tests are based mainly on visual performance. The available tests suffer from     high false negative errors. This raises questions regarding their ability to correctly     diagnose ADHD.      With the expanding knowledge regarding the neurobiological basis in ADHD we have learned that     attention is not a general property of the whole brain, but involves several coordinated     networks. This knowledge promoted us to the stage in which we can recognize different types     of attention domains.      Our diagnosis test can separate between the different attention abilities and provide     specific diagnosis. Our program is individually fits for the specific child difficulties and     covers a wider range of needs. So, it can be helpful to a larger variety of children with     different needs.   "
213448|NCT00647101|"     The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure     reduction in patients with ocular hypertension or open-angle glaucoma.   "
213403|NCT00646490|"     Key words : serum, pleural effusion, procalcitonin, pneumonia Pneumonia is the common cause     of pleural effusion (ranged 2nd) and bacterial infection is the main etiology of pneumonia.     Procalcitonin, the prohormone of calcitonin, is a 116 amino-acid protein produced by C-cell     of the thyroid gland. During severe infection, procalcitonin is probably produced by     extra-thyroid tissues and the concentration increased rapidly in bacterial infection but     remains low in viral infections. However, the exact origin and pathophysiological role of     procalcitonin during sepsis is not clear and it is not a marker of infection as such, since     localized infections or infections with no systemic manifestation cause a little if any     increase in procalcitonin levels. This study will focus on assessing the value of     procalcitonin in pleural effusion for diagnosis, severity and prognosis among     community-acquired pneumonia with pleural effusion, such as in serum. 100 patients with     clinical pneumonia infection score over six points diagnosed of community-acquired pneumonia     and proved to have pleural effusion by chest sonography on admission will be studied     prospectively. Serum and effusion procalcitonin levels will be measured initially and 3 days     later after medical therapy. Bacterial pneumonia will be identified if bacteria was cultured     from any one of the three kinds of specimen, including blood, pleural effusion or     bronchoalveolar lavage. Then we will divide one hundred of patients into bacterial or     non-bacterial groups. Finally, we will analyze demographic and procalcitonin data of serum     and pleural effusion between these two groups and compare the difference between the severe     or mild and response or non-response bacterial community-acquired pneumonia statistically.      The aim of the study will be to verify whether procalcitonin levels measured in the serum and     pleural effusion could serve as a predictor for bacterial community-acquired pneumonia with     pleural effusion and the different levels will also be indicative of severity and prognosis.     We hope that the predictor from pleural effusion will be more sensitive or specific than that     from serum and could be detectable in localized bacterial infection.   "
213404|NCT00646503|"     This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.   "
213405|NCT00646516|"     The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will     improve lung function and symptoms of adults and adolescents with asthma.   "
213406|NCT00646529|"     The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in     asthmatic children aged 6 to 11 years   "
213407|NCT00646542|"     This clinical trial is designed to provide additional information on the safety and     tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2     diabetes mellitus (T2DM) and moderate or severe renal insufficiency.   "
213436|NCT00646919|"     We intend to take a nasal swab from each pediatric pre-operative patient in our out-clinic     with the intention of looking for a connection between positive operative incisions and a     positive nasal swab. The patients will be in the out-patient clinic for a few hours, and will     be examined post-operatively after one week. Those with positive nasal swabs will be advised     to apply a nasal cream (Mupirocin)in their noses for one week. Our hypothesis is that there     is a correlation between positive nasal swabs and positive incision infections.   "
213437|NCT00646932|"     The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks     (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3     times a week for stable chronic renal failure.   "
213501|NCT00647790|"     The purpose of this study is to find a way to learn the hormone receptor status of a tumor     before surgery is done. By testing for the hormone receptor proteins, doctors can find out if     the breast cancer uses hormones to grow. This is important since the hormone receptor status     of a tumor helps doctors decide if extra treatment like chemotherapy or pills are needed.   "
213408|NCT00646555|"     This study, conducted by the NCI and the George Washington University Medical Center (GWUMC),     will examine breast tissue from patients with inflammatory breast cancer (IBC) for tumor     markers and factors associated with angiogenesis. Angiogenesis is the formation of new blood     vessels that is essential for tumor growth and spread. IBC is an extremely rare, aggressive     form of breast cancer that disproportionately affects young women. The risk factors for IBC,     its cause, and how it develops are unknown, but the disease appears to involve a high degree     of angiogenesis.      Tissue specimens for this study will be obtained from GWUMC's Inflammatory Breast Cancer     Registry and Biospecimen Repository. The registry was established to develop a national     registry of patients with IBC that includes standardized clinical, epidemiological, and     pathological information, along with disease recurrence and survival data.      For this study, tissue specimens from the repository will be tested for biological markers     and angiogenesis parameters to help in the classification of the tumors. Biological markers     (such as estrogen receptor, progesterone receptor, the p53 gene, and others) and angiogenesis     parameters (such as various proteins involved in vessel formation) will be examined to     determine their prevalence in tissue specimens and their relationship to patient survival.     When possible, the findings will be compared with non-IBC tissue samples.   "
213409|NCT00646568|"     In an era of delayed fertility plans, there is an increasing need for a reliable method to     predict ovarian reserve and responsiveness. The current tests include serum FSH, Inhibin B,     Mullerian inhibiting factor (MIF) and ultrasonographic measures such as ovarian volume and     number of antral follicles are non-specific and with questionable reliability. The     biochemical tests represent the function of production of androgens, as a predictor of     ovarian reserve, has not been tested yet.      Working hypothesis and aims: testing the prognostic capability of hCG stimulating test of     theca cells for estimating the ovarian reserve, and by that to calculate better the chance     for IVF cycle success   "
213410|NCT00646581|"     The purpose of the study is to find out how a small dose of insulin might affect memory, the     ability to concentrate, and improve your daily functioning in patients with schizophrenia and     schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The     investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal     insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's     effect on cognition. The specific aims include:        1. Examine the effects of single doses of 40 IU intranasal insulin compared to placebo on          cognitive functioning, including attention and memory.        2. Examine whether single dose of intranasal insulin administration will raise serum          insulin level and decrease plasma glucose level      Insulin will be delivered through an air spray pump into your nose. The investigators will be     comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.   "
213411|NCT00646594|"     The purpose of this study is to determine whether Symbicort compared with Advair, will be     more effective in controlling asthma in adults and adolescents.   "
213412|NCT00646607|"     This project consists of two independent, following specific eligibility criteria and     different randomisation schemes studies, later on called DURATION study and BEV study. Once     randomised in the duration study, patients fulfilling eligibility criteria for BEV study may     also be randomized to receive BEV or no BEV, in addition to FOLFOX-4 chemotherapy.      As both are open label studies, there will be no blinding of treatment assignment.   "
213413|NCT00646620|"     The purpose of this study is to compare the early onset of effect of Symbicort compared to     Advair Diskus and Ventolin in adults with asthma   "
213414|NCT00646633|"     Based on the investigators clinical experience in patients with chronic disease (Hui, Hui,     and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui     2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a     pilot study that investigates if acupuncture combined with patient education will relieve     fatigue in patients who have completed primary treatment for breast cancer.   "
213415|NCT00646646|"     The purpose of this study is to determine whether sedation affects saccadic eye movements.   "
213433|NCT00646880|"     The purpose of this study is to compare the difference between tolterodine prolonged release     (PR) and propiverine in efficacy as assessed by the AUM and to show that tolterodine PR is     similar to propiverine with respect to micturition chart variables and safety profile.   "
213449|NCT00647114|"     Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens.   "
213416|NCT00646659|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth     of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high energy x-     rays to kill tumor cells. Cetuximab may also make tumor cells more sensitive to radiation     therapy. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. It is not yet known which     regimen of radiation therapy, combination chemotherapy, and cetuximab and is most effective     in treating patients with head and neck cancer.      PURPOSE: This randomized phase II trial is comparing two different regimens of radiation     therapy given together with combination chemotherapy and cetuximab to see how well they work     in treating patients with newly diagnosed stage III or stage IV head and neck cancer that     cannot be removed by surgery.   "
213438|NCT00646945|"     In the oncology practice, The National Union of the Centres of Fight Against the Cancer     recently published the Standards, Options and Recommendations for the coverage of the pains     provoked during the invasive gestures of a short duration realized at patients affected by     cancer. These support the use of the Kalinox ® 170 bar as therapeutic alternative for the     preparation of the painful procedures of a short duration such as spinal taps or osseous at     the adult.The objective of this study thus is to clarify the appropriate efficiency and the     tolerance of the equimolar mixture protoxide of nitrogen / oxygen during invasive procedures     realized in adult oncology with regard to the analgesic reference methods and to the effect     placebo leads by the accompaniment of the patient during the procedure.   "
213439|NCT00646958|"     The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an     oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated     skin and skin structure infections   "
213417|NCT00646672|"     This study will determine the risk of brain aneurysm (abnormal outpouching of a brain artery)     in young adults who had their carotid artery tied off as an infant as part of the     extracorporeal membrane oxygenation (ECMO) procedure. This procedure is sometimes performed     on newborns with lung problems so that they can have oxygen brought to their blood outside     the body. ECMO operates similar to a heart-lung machine. Blood drained from the veins has the     carbon dioxide removed and oxygen added. The oxygenated blood is then returned to the body     through the arteries.      People 18 to 25 years of age who underwent ECMO as an infant at the Children's National     Medical Center in Washington, D.C., may be eligible for this study.      Participants undergo the following procedures:        -  Medical history and physical and neurological examinations.        -  Magnetic resonance imaging (MRI) of the head and neck. MRI uses a strong magnetic field          and radio waves to obtain images of body organs and tissues. The subject lies in the          scanner (a metal cylinder surrounded by a magnetic field) for about 90 minutes, lying          still for up to 15 minutes at a time. During part of the procedure, a contrast dye is          injected into a vein through a catheter (thin plastic tube) to enhance the images.   "
213418|NCT00646685|"     The purpose of this study is to empirically determine whether one of 2 surgical techniques     commonly used for bile duct reconstruction during living donor liver transplantation results     in fewer biliary complications. Also, this study may identify patient group(s) that     particularly benefit from a particular technique.   "
213419|NCT00646698|"     Context: Upper body obese (UBO) subjects are more likely to develop cardiovascular disease     (CVD) than lower body obese (LBO) or lean. This may in part be caused by greater hepatic     secretion of very-low-density-lipoprotein-triglycerides (VLDL-TG).      Objective: To assess the impact of body composition and insulin sensitivity on basal VLDL-TG     turnover in women.   "
213420|NCT00646711|"     To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets     to Depakote ER tablets in the pediatric population.   "
213421|NCT00646724|"     The study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal     Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional     Mesenchymal Stem Cell infusion can benefit the promising clinical islet transplantation     through the following mechanisms: protection of islet from inflammatory damage, immunological     modulation, engraftment promotion, thus decrease or eliminate the need of exogenous insulin     and improve β-cell function.   "
213422|NCT00646737|"     The purpose of this study is to evaluate the safety and the tolerability of the substitution     of mycophenolate mofetil for enteric-coated mycophenolate sodium in a population of stable     renal transplant patients in Brazil, in a treatment regimen of immunosuppressants with     tacrolimus and mycophenolate mofetil.   "
213423|NCT00646750|"     To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin)     administration in the conditioning treatment of patients with refractory large B-cell diffuse     lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem     cells.   "
213424|NCT00646763|"     The purpose of this study is to determine whether or not the injection site of cytokines, or     growth factors, has an effect on peripheral blood stem cell collection.   "
213425|NCT00646776|"     The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered     with atazanavir and ritonavir (ATV/RTV)   "
213426|NCT00646789|"     To evaluate the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent     mild-to-moderate asthma patients to permit further clinical investigation.   "
213427|NCT00646802|"     Eligible patients will be informed and asked to enroll in the study at hospital admission. A     transvaginal ultrasound examination will be performed to determine cervical length. If an     eligible woman accepts to participate, patient will be randomized to one of the study arms     assigned in a double blind basis. Patient will receive the medication (vaginal capsule of     progesterone or placebo). The patient will administer herself one vaginal capsule in a daily     basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate     that the use of a maintenance treatment with vaginal progesterone is able to reduce the     incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal     and neonatal data will be collected.   "
213428|NCT00646815|"     The purpose of this study is to further characterize the treatment related changes in insulin     sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with     growth hormone deficiency (GHD).   "
213429|NCT00646828|"     Vascular and cardiac alterations are associated with aldosterone effects are evidenced in     experimental models and aldosterone receptor blockade is of clear benefit in cardiac disease     (heart failure). The study aims at assessing vascular and cardiac alterations in adults with     a chronic increase in circulating aldosterone without hypertension. The investigated     population will be patients with a rare disease, pseudohypoaldosteronism type 1, due to     heterozygous inactivating mutations of the mineralocorticoid receptor.   "
213430|NCT00646841|"     The primary objective was to determine the effects of the Gastrointestinal Therapeutic System     (GITS) formulation of Doxazosin when used in combination therapy with the 5 major classes of     antihypertensive agents as measure by 24-hour diastolic blood pressure.   "
213431|NCT00646854|"     The purpose of this study is to determine efficacy and safety of the monoclonal antibody     MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma.   "
213435|NCT00646906|"     This research study investigates whether the ability of aspirin to reduce the risk of heart     attacks may be diminished by the administration of acetaminophen. Patients who have heart     disease are often prescribed aspirin because of its unique ability to permanently prevent     platelets from aggregating and forming a blood clot. Such blood clots cause heart attacks     when they form in a blood vessel that supplies the heart with oxygen rich blood. Some of     these same patients also take acetaminophen everyday for relief from arthritis pain. Higher     doses of acetaminophen may also have the ability to prevent the platelets from clotting,     however only temporarily. Therefore, this study evaluates whether the timing of the     administration of acetaminophen (before or after aspirin) interferes with the permanent blood     clotting effects of aspirin.      The primary hypothesis is that acetaminophen given two hours before aspirin will antagonize     the effects of aspirin, while reversing the order of administration will not.   "
213440|NCT00646971|"     Patients with sleep apnea syndrome have repeated apneic events that induce periodic     hypoxia-reoxygenation, drawing away an overproduction of oxidants. This exaggerated     generation of oxidants is associated with a dysfunction of the vascular endothelium that     evolves, in its turn, towards cardiovascular diseases such as systemic hypertension, stroke,     and myocardial infarction. The major aim of our study is to examine the effect of CPAP     treatment on biochemical (markers of oxidative stress) and functional (endothelium-dependent     vascular relaxation reactivity) abnormalities at 1 and 4 weeks of treatment.   "
213441|NCT00646984|"     Aim: To assess the safety on the progression of HIV infection and the efficacy on the     evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven     strategies of intermittent treatment in chronically HIV-1-infected persons.      Design: Pilot, prospective, open, randomized, controlled 3-year study.      Setting and patients: University hospital. Patients with viral load <200 copies/mL and CD4     cell count >450/mm3 for at least the last 3 months. Three arms with 50 patients each, that     will be randomized either to continue antiretroviral therapy, or to discontinue it as long as     either HIV-1 RNA be lower than 30000 copies/mL or CD4 cell count be higher than 300/mm3.      Study end-points: evolution of plasma metabolic parameters, body fat, and bone mineral     density; incidence of adverse effects due to antiretroviral therapy and symptoms consistent     with acute retroviral syndrome; incidence of virological failure (plasma HIV-1 RNA >200     copies/mL while on therapy), immunological failure (CD4 cell count <200/mm3 while on     therapy), or clinical failure (development of AIDS-defining illnesses); cost of     antiretroviral therapy administered and time free of therapy in the arms assigned to     intermittent treatment; and the evolution of T lymphocyte subpopulations and the development     of proliferative and cytotoxic responses against HIV.   "
213442|NCT00646997|"     We aimed to demonstrate the impact of left atrial functions which were evaluated by three     different echocardiographic modalities , on postoperative atrial fibrillation.   "
213443|NCT00647023|"     The incretin hormones are secreted from the gastrointestinal tract in response to nutrient     ingestion, and are responsible for 70 % of insulin secretion in response to glucose. The     incretin response is attenuated in subjects with type 2 diabetes and other conditions     associated with insulin resistance. Polycystic ovary syndrome (PCOS) is characterised by     irregular periods and increased androgen levels. It is the most common endocrine disorder     amongst young women at fertile age, and the most common cause of female infertility. Insulin     resistance plays an important role in the development of the disease, and women with PCOS are     at increased risk of developing tyoe 2 diabetes. the incretin hormones have not previously     been investigated in women with PCOS, and the purpose of the present study was to investigate     the secretion of the two most important incretin hormones Glucose-like peptide-1 (GLP-1) and     Glucose dependent insulinotropic peptide (GIP) during a three hour oral glucose tolerance     test.   "
213444|NCT00647036|"     We hypothesise that the addition of glutamine supplementation to both parenteral nutrition     and enteral feeds in surgical newborn infants leads to a reduction in bacterial invasion.   "
213445|NCT00647049|"     The purpose of this study is to determine whether combined chemotherapy [rituximab plus high     dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed     by high dosage carmustin/thiotepa] followed by peripheral blood stem cell transplantation is     effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL].   "
213446|NCT00647075|"     The purpose of this study is to assess the effects of a dietary supplement, the traditional     Asian mushroom Yunzhi, as adjuvant in the treatment of patients with breast cancer.   "
213447|NCT00647088|"     Pathophysiology of Aortic Valve Stenosis remains poorly known. The aim of the present study     is to identify genetic factors involved in this disease using a case control trial design.   "
213451|NCT00647140|"     Medullary thyroid carcinoma (MTC) is a rare tumor arising from C cells of the thyroid gland     and belonging to the endocrine tumors. 18F-DOPA PET, based on tha capacity of endocrine tumor     cells to take-up, decarboxylate and store amino-acids, such 3-4-dihydroxyphenylalanine(DOPA),     is used for imaging endocrine tumors. The aim of the study was to evaluate the contribution     of 18F-DOPA whole-body PET for the detection of recurrences in patients with proven recurrent     MTC without evidence of recurrence or metastases on several imaging modalities.   "
213452|NCT00647153|"     RATIONALE: Diagnostic procedures, such as immunoscintigraphy, using a radiolabeled monoclonal     antibody may help find and diagnose colorectal cancer.      PURPOSE: This clinical trial is studying how well immunoscintigraphy using a radiolabeled     monoclonal antibody works in finding tumor cells in patients with colorectal cancer.   "
213453|NCT00647166|"     To determine whether a combination of corticosteroids and azathioprine can achieve a higher     remission rate and a lower subsequent relapse rate in patients with newly-diagnosed     microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with     polyangiitis (Churg Strauss syndrome) with no poor prognosis factor (FFS=0), and without     significantly increasing the rate of adverse events, as compared to corticosteroids alone.     The study hypothesis is a reduction of the absolute risk of treatment failure or relapse     within the first 24 months following initiation of therapy of least 25%.   "
213454|NCT00647179|"     The purpose of this study is to investigate the effects of chronic elevated growth hormone on     metabolism and insulin sensitivity by studying acromegalic patients before and after     treatment.   "
213455|NCT00647192|"     The purpose of this study is to determine whether Eplerenone reduces atrial fibrillation (AF)     recurrences within the first 8 weeks after electrical cardioversion of persistent AF.   "
213456|NCT00647205|"     The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube® and     T-SPOT.TB® for the diagnosis of latent tuberculosis in HIV infected antiretroviral naive     patients: 80 originated from low TB prevalence countries, without any active TB; 80 HIV     infected antiretroviral naïve patients originated from high TB prevalence countries, without     any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with     active TB.   "
213471|NCT00647400|"     To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants     with psoriasis   "
213502|NCT00647816|"     The objective of this study was to investigate the bioequivalence of Mylan's propranolol     hydrochloride extended-release 160 mg capsules to Wyeth's Inderal LA® 160 mg capsules     following a single, oral 160 mg (1 x 160 mg) dose administration under fasting conditions.   "
213457|NCT00647218|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel and     radiation therapy before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells     that remain after surgery.      PURPOSE: This clinical trial is studying how well giving paclitaxel together with radiation     therapy works in treating patients undergoing surgery for stage II or stage III breast     cancer.   "
213458|NCT00647231|"     The objective of this study is to characterize the analgesic properties of single dose study     of HKT-500 in subjects with pain caused by mild to moderate OA of the knee   "
213459|NCT00647244|"     To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in     HIV-infected patients   "
213460|NCT00647257|"     This is a an investigator-initial, multicenter, open-label, randomized, parallel-group     comparative study to evaluate the effect on the incidence of AF and pacemaker dependence in     SSS patients receiving physiological atrial-based pacing alone or adding losartan 100mg to     physiological atrial-based pacing treatment. The duration of the study will be approximately     13 months, comprising 4-week pre-study period, and 12-month treatment period.   "
213461|NCT00647270|"     To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and     demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of     40 mg adalimumab every other week.   "
213462|NCT00647283|"     In liver transplantation up to 20% of recipients can completely discontinue immunosuppressive     therapy maintaining normal graft function, and are conventionally considered as operationally     tolerant. Discontinuation of immunosuppressive drugs in operationally tolerant recipients     could lessen the side effects of chronic immunosuppressive therapy. However, this strategy     results in the development of rejection in a high proportion of recipients who require     lifelong immunosuppression. Thus, there is a need to identify predictive factors of     successful drug withdrawal and to define the clinical and histological outcomes of     operationally tolerant liver recipients.      The main objective of this study is to establish the safety of attempting immunosuppressive     (IS) drug withdrawal in stable liver transplant recipients, using standard clinical,     biological and histopathological methods, to screen and follow-up patients, and to confirm     the benefit of maintaining immunosuppressive drug interruption in patients who are tolerant     to their liver transplant. The secondary objective of this study is to identify predictive     factors of operational tolerance and to attempt to develop a multi-parameter decision rule     to predict patient tolerance or non-tolerance in order to improve patient screening and     follow-up. In a diagnostic observational sub-study, peripheral blood and liver tissue samples     collected before immunosuppressive drug withdrawal will be employed to validate the     diagnostic accuracy of a previously identified set of tolerance biomarkers and to identify     potential new biomarkers capable of predicting the outcome of the immunosuppressive     withdrawal protocol.   "
213463|NCT00647296|"     This is a 2-part study of KNS-760704 in patients with ALS.        -  Part 1 is a randomized, placebo-controlled, multi-center study to evaluate the safety,          tolerability, and clinical effects of oral administration of 3 dosage levels of KNS          760704 vs. placebo for 12 weeks.        -  Part 2 is a randomized, double-blind, 2-arm, parallel group, extension study evaluating          the safety, tolerability, and clinical effects of oral administration of 2 dosage levels          of KNS-760704 for up to 76 weeks.   "
213464|NCT00647309|"     Elevated troponin is powerful and independent adverse prognostic marker in patient with ACS.     However, non specific (non cardiac) troponin elevation is a common finding among hospitalized     patients and worse prognosis too.      The aim of this study is examine the prevalence of incidental cardiac troponin rise in a     group of patient aged 65 and over admitted to geriatric department with hip fracture, and     influence of troponin elevation on outcomes like ACS, death, motor and cognitive function.   "
213947|NCT00644202|"     The purpose of this study is to examine how adults can improve their physical activity levels     and eating habits using an interactive web-based weight control program and regular contact     with a dietician.   "
213465|NCT00647322|"     The primary aim of the study is to determine the effect of reducing the number and/or dose of     anti epileptic drugs on an individual's quality of life and seizure control in people with     difficult to control epilepsy and who are on polytherapy.      This is a randomised trial so children will be divided into two groups, with reduction of     anti epileptic drugs in the first group (withdrawal group) and no change to their medications     in the second (control group). Irrespective of the group the child is assigned to (withdrawal     group or control group), we will ask parents to complete several questionnaires on 2     occasions: the first time will be immediately after the child enters the study (i.e. baseline     assessment), and a second and last one will be 6 months after entering the study (i.e.     follow-up assessment). These questionnaires aim to quantify aspects related with quality of     life, AED side effects, seizure severity, and behaviour.   "
213466|NCT00647335|"     The purpose of this study is to look at genes (DNA) and how they affect health and disease.     Genes are the instruction manual for the body. The genes you get from your parents decide     what you look like and how your body behaves. They can also tell us a person's risk for     certain diseases and how they will respond to treatment. We will collect a saliva sample for     genetic research.   "
213467|NCT00647348|"     To determine whether simvastatin at a dose of 80mg can reduce the rate of whole brain     atrophy, as measured by MRI, over a 2-year time-period when compared to placebo.   "
213468|NCT00647361|"     Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA     delivers assist to spontaneous breathing based on the detection of the electrical activity of     the diaphragm. We study the effect of NAVA on cardiac performance in critically ill,     mechanically ventilated patients.   "
213469|NCT00647374|"     The proposed project will study the consequence of short term limb immobility on the patterns     of brain activity using functional imaging (fMRI)   "
213470|NCT00647387|"     The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA)     in September, 2007. This study is designed to further evaluate the safety and effectiveness     in subjects implanted with the AMPLATZER Muscular VSD Occluder.   "
213472|NCT00647413|"     Background: Infants are at risk for tobacco-attributable diseases by being exposed to     environmental tobacco smoke (ETS). International literature has shown that a home smoking ban     can reduce ETS. The purpose of this study is to examine whether a brief feedback about     urinary cotinine in infants and a counselling session about the consequences of ETS leads to     a reduction of ETS.      All families with children up to an age of three years in the study region will be contacted     by mail and asked for participation in this study. They will be randomised into an     intervention and one control group. The intervention group will receive a ETS counselling     session and detailed analysis of urinary cotinine (a biomarker of ETS) at their home. They     will further receive written feedback approx. 2 weeks later. The control group will be     visited and will answer a questionnaire and will receive brochures about ETS. They will     receive a standard analysis feedback of urinary cotinine. There will be oine further     assessment/ visit 12 months later. The outcome of this study is an anlysis of urinary     cotinine and smoking behaviour and changes in cotinine and smoking behaviour.   "
213473|NCT00647426|"     This is an open-label, single institution, phase II study of Sorafenib in combination with     docetaxel and carboplatin in patients with advanced non-small cell lung cancer. Docetaxel and     carboplatin will be given on day 1 of every three week cycle. Patients will take Sorafenib     twice a day on the 1st day of treatment and continue to take the medication every day until     progression of disease, prohibitive toxicity, or patient withdrawal from the study.     Chemotherapy courses will repeat every 21 days in the absence of disease progression or     unacceptable toxicity for a total of four cycles.   "
213474|NCT00647439|"     This study will identify genes that are associated with inflammation or degeneration of the     retina (membrane lining the back of the eye that relays vision signals to the brain). It is     thought that many retinal conditions are due to an altered immune system and are based on how     the person s genes function and communicate.      People 4 years of age or older who have a retinal condition such as uveitis, age-related     macular degeneration or diabetic retinopathy may be eligible for this study. Healthy     volunteers and healthy people who have a family member with one of these conditions are also     eligible. Patients with inherited retinal degeneration are excluded.      Participants undergo the following tests and procedures:        -  Eye examination to assess visual acuity (eye chart test) and eye pressure, and to          examine the pupils, lenses, retina and eye movements. Photographs of the inside of the          eye may also be taken. The pupils are dilated with drops for this examination.        -  Blood draw for genetic testing.      Participants may also undergo one or more of the following tests:        -  Optical coherence tomography. This is a type of photograph of the back of the eye to          measure thickness of the retina.        -  Fluorescein angiography and indocyanine green angiography. Pictures of the eye s blood          vessels are taken using either a fluorescein or indocyanine green dye. The dye is          injected into a vein in an arm and travels to the blood vessels in the eyes. A camera          takes pictures of the dye as it flows through the blood vessels.        -  Electroretinogram (ERG) to measure retinal function. The patient sits in a dark room for          30 minutes with his or her eyes patched. Then, a small metal disk electrode is taped to          the forehead, the eye patches are removed, the surface of the eye is numbed with eye          drops, and contact lenses are placed on the eyes. The patient then watches flashing          lights. The contact lenses sense small electrical signals generated by the retina when          the light flashes.   "
213475|NCT00647452|"     Purpose:      To investigate VLDL-TG metabolism in exercise in healthy volunteers to determine the     contribution of VLDL-TG in exercise and eventual gender differences   "
213476|NCT00647465|"     Influenza vaccination reduces the morbidity and mortality associated with influenza infection     in at risk groups including the elderly and individuals with an impaired immune response, but     is not totally protective in all recipient. Cytokines including type I interferons are known     to play a key role in the innate immune response to virus infection and in the induction of     the primary adaptive-immune response. Thus, we evaluated the safety of sublingual     administration of IFNa and its effect on immune response to influenza vaccination in a     randomized double-blind placebo controlled study in elderly institutionalized individuals.   "
213477|NCT00647478|"     The aim is to assess the relationship between levels of IGF-I system components and cognitive     status in patients with Alzheimer's disease (AD), in elderly subjects with normal cognitive     function, and in patients with mild cognitive impairment (MCI).   "
213478|NCT00647491|"     The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics     of three doses of adalimumab in adult Japanese subjects with RA   "
213680|NCT00650351|"     The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin     extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single,     oral 1000 mg (1 x 1000 mg) dose administered under fed conditions.   "
213479|NCT00647504|"     Prospective clinical observational registry study including consecutive patients with     clinical signs or symptoms due to in-stent restenosis (ISR) or definite (ARC criteria) stent     thrombosis (ST).      Study hypothesis:      Initial Stent implantation quality (due to technique/problems) are possible major     determinants of ST and ISR in real life practice.      Both early, late, and very late ST, and ISR are important factors for long term outcome after     initial stent implantation.      Primary objective:        -  To elucidate the possible cause(s) of thrombosis or restenosis after stent implantation          in real life practice by clinical, angiographic and IVUS evaluation.      Secondary objective:        -  To describe the clinical manifestation [stable angina pectoris (AP), unstable AP,          non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation MI] of the index event          (inclusion).        -  To describe the characteristics of patient, lesion and procedure of the initial          percutaneous coronary intervention (PCI).        -  To describe the antithrombotic pharmacological therapy preceding the index event.        -  To describe clinical outcome (death, MI, revascularization, CCS angina class) following          treatment of the index event during 12 month follow-up.        -  To describe safety of the IVUS procedure (product or procedural related complications/          malfunctions).   "
213480|NCT00647517|"     Tramadol 37.5 mg/APAP 325 mg combination tablets (ULTRACET®) were effective and safe as addon     therapy with COX-2 NSAID for treatment of osteoarthritis (5) and chronic low back pain     (6).There is no clinical trial regarding tramadol usage in chronic inflammatory arthritis     such as rheumatoid arthritis (RA) or ankylosing spondylitis. It would be important to do a     pilot clinical trial on add-on effect of tramadol to NSAID in patients with AS or RA.   "
213499|NCT00647764|"     Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an     experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in     patients with cancer.   "
213500|NCT00647777|"     The objective of this study was to investigate the bioequivalence of Mylan olanzapine 5 mg     tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose     administered under fed conditions.   "
214704|NCT00654173|"     The purpose of this study is to compare the efficacy and safety of rosuvastatin with     simvastatin and atorvastatin in reducing levels of low density lipoprotein cholesterol in     subjects with hypercholesterolaemia   "
213481|NCT00647530|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs     to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after     surgery. It is not yet known whether chemotherapy is more effective with or without     panitumumab in treating patients with colon cancer.      PURPOSE: This randomized phase III trial assessing whether preoperative chemotherapy and/or     an anti-EGFR monoclonal antibody improve outcome in high risk operable colon cancer.   "
213482|NCT00647543|"     The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol     on patients from Thailand with high cholesterol.   "
213483|NCT00647556|"     The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel     0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with     tolerability assessment as a secondary objective.   "
213484|NCT00647569|"     The aim of the present project is to investigate whether use of biological mesh at the donor     site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional     hernia formation compared to the usual abdominal wall closure after abdominal rotation flap     operation in surgery for advanced pelvic cancer.   "
213485|NCT00647582|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy during and after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying the side effects of giving radiation therapy during     and after lumpectomy and to see how well it works in treating women with stage I or stage II     breast cancer.   "
213486|NCT00647595|"     The purpose of this study is to examine the effect of exercise during pregnancy upon maternal     metabolism, including weight gain, fat distribution, and levels of glucose and cholesterol.     We will also conduct a pilot study to examine the feasibility of studying the health of     infants born to women in this study.   "
213487|NCT00647608|"     The objective of this study was to investigate the bioequivalence of Mylan's propranolol     hydrochloride extended-release 160 mg capsules to Wyeth's Inderal® LA 160 mg capsules     following a single, oral 160 mg (1 x 160 mg) dose administered under fed conditions.   "
213488|NCT00647621|"     The objective of this study was to investigate the steady-state bioequivalence of Mylan's     extended phenytoin sodium capsules, 100mg (3x100mg), to Pfizer's Dilantin® Kapseals®, 100mg     (3x100mg), under both fasting and fed conditions.   "
213489|NCT00647634|"     The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 3 mg     Extended-release tablets to Pharmacia & Upjohn's Xanax XR® 3 mg tablets following a single,     oral 3 mg (1 x 3 mg) dose administered under fasting conditions.   "
213490|NCT00647647|"     The objective of this study was to investigate the bioequivalence of Mylan's terbinafine     hydrochloride 250 mg tablets to Novartis' Lamisil® 250 mg tablets following a single, oral     250 mg (1 x 250 mg) dose administered under fasting conditions.   "
213491|NCT00647660|"     The objective of this study was to investigate the bioequivalence of Mylan's     nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets     following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose administered under fasting     conditions.   "
213492|NCT00647673|"     The objective of this study was to investigate the bioequivalence of Mylan's verapamil HCl     extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules     following evening administration of a single, oral 300 mg (1 x 300 mg) dose under fasting     conditions.   "
213493|NCT00647686|"     The objective of this study was primarily to investigate the bioequivalence and secondly to     assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system     with and without an overlay system following a single 25 µg/hr application worn for 72 hours.   "
213494|NCT00647699|"     Prospective, randomized multicenter study to determine the safety and effectiveness of     performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with     progressive keratoconus.   "
213495|NCT00647712|"     The objective of this study was to investigate the bioequivalence of Mylan's divalproex     sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a     single, oral 500 mg (1 x 500 mg) dose administered under fasting conditions.   "
215276|NCT00668057|"     This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with     matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.   "
213496|NCT00647725|"     Painless labor is an essential part in woman's health care. Labor analgesia in the active     phrase is in popular use currently. However, parturients are still haunted by the labor     delivery pain in the latent phrase up to 7-8 hours, especially for the nulliparas. Therefore,     we hypothesized that labor analgesia in the latent phrase of the first delivery stage would     provide superior health care for laboring women. In addition, such analgesia technique would     not prolong the time of uterine dilation and labor delivering.   "
213497|NCT00647738|"     The objective of this study was to investigate the bioequivalence of Genpharm's baclofen     tablets following a single, oral 20 mg (1 x 20 mg) dose compared to the Baclofen USP (Watson     Laboratories Inc., USA) administered under fasting conditions. Twenty-seven (27) healthy,     light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this     two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M.D. at     Algorithme Pharma Inc. Montreal, Canada.      Statistical analysis of the data reveals that 90% confidence intervals are within the     acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters     AUCT, AUCI and Cmax. This study demonstrates that Genpharm's baclofen 20 mg tablets are     bioequivalent to Baclofen USP 20 mg tablets (Watson Laboratories Inc., USA) administered     under fasting conditions.   "
213498|NCT00647751|"     The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25     mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg     (2 x 25 mg) dose administration under fed conditions.   "
213503|NCT00647829|"     The study was performed to evaluate the analgesic efficacy, safety, and tolerability of     valdecoxib 20 mg twice daily (BID), valdecoxib 40 mg once daily (QD), and placebo in patients     with moderately to severely painful symptomatic sore throat over a 24-hour period. In     addition, the study was to validate a new scale and criteria for measuring pain in sore     throat and evaluate the effects of selective serotonin reuptake inhibitors and past sore     throat pain on pain score and efficacy of analgesics. The study also examined what type of     medications are commonly used for sore throat and whether this information has relevance to     analgesic efficacy.   "
213504|NCT00647842|"     The objective of this study was primarily to investigate the bioequivalence and secondly to     assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system     with and without an overlay system following a single 25 µg/hr application worn for 72 hours.   "
213505|NCT00647855|"     The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine     sodium 300 μg tablets to Abbott's Synthroid® 300 μg tablets following a single 600 μg (2 x     300 μg) dose administered in healthy volunteers under fasting conditions. Single-dose     pharmacokinetic parameters for baseline corrected total L-thyroxine and non-baseline     corrected total L-triiodothyronine were calculated using noncompartmental techniques.   "
213506|NCT00647868|"     In this study the serum concentration of testosterone and its main metabolite DHT will be     measured in hypogonadal men using intranasal testosterone (Nasobol). Different treatment     regimens (once and twice daily) and administration times will be tested. The serum levels     obtained will be compared with those of healthy men.      It is expected that intranasal administration of Nasobol will restore testosterone and DHT     levels to nearly normal.   "
213507|NCT00647881|"     The objective of this study was to investigate the bioequivalence of Mylan's paroxetine     hydrochloride controlled-release 25 mg tablets to GSK's Paxil CR™ 25 mg tablets following a     single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.   "
213508|NCT00647894|"     The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 1 mg     Extended-release tablets to Pharmacia & Upjohn's Xanax XR 1 mg tablets following a single,     oral 3 mg (3 x 1 mg) dose administered under fasting conditions.   "
213509|NCT00647907|"     The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment     of fungal infections   "
213510|NCT00647920|"     A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as     Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with     Methotrexate   "
213511|NCT00647933|"     The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety     of Org 36286 after a single subcutaneous administration in healthy females.   "
213512|NCT00647946|"     A previous study substituting zidovudine or stavudine to abacavir in patients with severe or     moderate lipoatrophy has shown an increase in limb fat by DEXA. This study was conducted over     a 24-week period and although improved outcomes were documented by objective measures, DEXA     scans, subjective observation did not correspond. Longer-term follow up of these patients is     required.      This 48 week study is designed to compare the substitution of the thymidine analogues     zidovudine (ZDV) or stavudine (D4T) with either tenofovir DF or abacavir, in patients treated     with highly active antiretroviral therapy (HAART), and show improved outcomes on total limb     fat mass, improved body shape by dual energy x-ray absorptiometry (DEXA) and computed     tomography (CT) scans and improved cholesterol and triglycerides.   "
213681|NCT00650364|"     The objective of this study was to investigate the bioequivalence of Mylan midodrine HCl 5 mg     tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose     administration under fasting conditions.   "
213513|NCT00638508|"     After surgery it is normal to experience some pain at the site of operation. In order to     reduce the pain, medication such as Morphine is injected into a vein using a Patient     Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient     when needed. However, Morphine is an opioid drug, which can cause side effects such as     sedation, nausea, vomiting, and reduced breathing on prolonged use. In addition to the opioid     drugs, local anesthetics, and other drugs called Non steroidal anti inflammatory drugs     (NSAIDs) have been injected locally to provide prolonged pain relief without the side effects     of morphine. Recently a portable device called ON-Q pump has been developed to continuously     infuse the local anesthetic through 2 small catheters inserted at the wound site. The ON-Q     Pump is a small tennis ball sized unit made of a soft synthetic material that slowly infuses     the drug through the catheters by elastic force. This pump is very safe and is attached to a     bedside pole or the patient's hospital gown. This pump has already been approved by the FDA     for clinical use, and has been reported to provide effective pain management after some     surgical procedures.      The primary aim of the present study is to evaluate the relative efficacy of the drugs     Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the pain following     gynecologic surgery. Ketorolac and Ropivacaine are approved drugs that are frequently used     for post operative pain relief. Our hypothesis is that these two drugs in combination will     provide better analgesia than Ketorolac alone.   "
213523|NCT00638638|"     Mechanical recanalization of the culprit artery in acute myocardial infarction using stents     provides in 2003, TIMI 3 flow restoration in more than 90% of patients. However, the     prognosis of this condition remains poor, to a large degree because of microcirculatory     dysfunction that is observed, in near than 20 to 40 % of patients, during or following     primary percutaneous intervention. The lack of ST-segment elevation resolution after     angioplasty with stenting is a marker of microcirculatory dysfunction and is associated with     a poor prognosis. Routine administration with primary stenting of the platelet glycoprotein     IIb/IIIa inhibitor Abciximab in acute myocardial infarction is still a matter of debate with     conflicting results emerging from two major clinical studies ADMIRAL and CADILLAC. However,     evidences are in favour of a benefit of this treatment especially when administrated early     (in a pre-hospital manner) before percutaneous coronary intervention.Our primary purpose is     to investigate the benefit of an early (i.e. pre-hospital) vs. a conventional (i.e.     per-angiography) administration of Abciximab on ST-segment elevation regression at one hour     after primary percutaneous angioplasty.   "
213524|NCT00638651|"     The purpose of this study is to evaluate the efficacy of tattoo removal using topical     imiquimod, 5% cream in conjunction with the 1064nm Nd:YAG laser. This procedure for tattoo     removal will be compared to a laser removal alone.   "
213514|NCT00638521|"     Organ failure following trauma is a leading cause of morbidity and mortality. It appears that     the development of organ failure is a direct result of an altered immune response. This     altered response results in the production of circulating factors in the blood that causes     direct injury to the injured patients' organs. The mechanism in which this altered immune     response occurs is unknown. Based on work we have performed in our laboratory, we believe     that this response is initiated on the cell membrane of particular immune cells known as     macrophages. Although the cell membrane may appear uniform, it is not. The membrane is     composed of specific segments that allow proteins to associate with each other forming     receptors that are required for immune cell activation. These specific membrane components     are composed of various lipids and cholesterol, and have been termed lipid rafts. Based on     our laboratory work it appears that these lipid rafts can be altered following injury. In     particular both the lipid and protein content within these raft segments may be altered     allowing immune cells to become active leading to the production of factors that directly     injure normal cells and organs. Thus, we plan to examine if these laboratory findings can be     seen in patients suffering from trauma who develop clinical organ failure at Harborview     Medical Center. If this is accomplished, this data will lead to the development of both     prognostic and therapeutic interventions for the optimal care of injured patient   "
213515|NCT00638534|"     The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5     days in children with acute otitis media (AOM).      Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of     telithromycin 20 mg/kg qd for 5 days in children with AOM.   "
213516|NCT00638547|"     This protocol will examine whether the enzyme alpha-L-iduronidase (Laronidase), delivered     into the spinal fluid of patients with Hurler syndrome at intervals before and after bone     marrow transplant, is a safe and effective approach to slow the neurologic degeneration seen     in Hurler patients undergoing transplantation.   "
213517|NCT00638560|"     The aim of the study is to compare the effects of an intensive 4 weeks exercise training     program with or without additional treatment with antioxidants. 16 volunteers are included     into the study and randomized into a treatment (n=8,Vitamine E 400 IU od + vitamine C 1g     twice daily) and a non-treatment (n=8, training only) group. Before and after the training     program, skeletal muscle biopsies will be taken to measure PGC-1alpha and PPARgamma mRNA     expression. In addition before and after the training program individuals will have the     following measurements: body weight, waist circumference, body fat content (DEXA scan),     euglycemic-hyperinsulinemic clamps, ergospirometer (VO2 max), routine laboratory     measurements, serum malondialdehyde concentrations.   "
213518|NCT00638573|"     The phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv)     glucose, even at identical plasma glucose (PG) profiles (isoglycemia), is called the incretin     effect. In type 2 diabetes mellitus (T2DM) the incretin effect has been shown to be markedly     reduced or even abolished. It is not known whether the reduced incretin effect in T2DM is a     primary event leading to T2DM or if it is merely a consequence of the diabetic state. To     answer this question the investigators plan to estimate the incretin effect in 8 patients     with secondary diabetes mellitus (DM) to chronic pancreatitis (CP) and compare it to the     incretin effect of 8 patients with CP and normal glucose tolerance (NGT). Eight patients with     T2DM and 8 healthy control subjects are studied for comparison. The incretin effect is     measured by a 50-g oral glucose tolerance test and an isoglycemic intravenous glucose     infusion.   "
213519|NCT00638586|"     Transradial access is a recently developed alternative for diagnostic andf interventional     cardiac catheterization. We sought to compare the differences between patients that have     undergone PTCA transradial and transfemoral access from the nursing point of view:        1. Anxiety levels        2. Pain at access point, pain in general and level of pain during mobility        3. Differences in feelings of embarrassement        4. Differences in satisfaction   "
213520|NCT00638599|"     Airway management in anesthesia is critical to guarantee appropriate treatment of possible     respiratory complications and successful operative practice. LMA® is an alternative to     tracheal tube in some surgeries like as mastectomy on breast cancer. Given no need using     muscular relaxants in mastectomy, the investigators hypothesized that LMA® would be a     superior manner in airway management in radical modified mastectomy on breast cancer than the     tracheal tube, and the LMA® might produce less influence on patients' circulatory     homeostasis, and easier to be placed before operation.   "
213521|NCT00638612|"     The purpose of this Phase 1 study is to evaluate the safety and potential efficacy of Gene     Mediated Cytotoxic Immunotherapy for pancreatic cancer. The approach uses an adenoviral     vector (disabled virus) engineered to express the Herpes thymidine kinase gene (AdV-tk),     followed by an antiherpetic prodrug, valacyclovir.   "
213682|NCT00650377|"     The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg     tablets and Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose     administration under fed conditions.   "
213522|NCT00638625|"     The purpose of this study is to compare the features that the pathologist sees, when     examining a lung tumor under the microscope, to the way that the tumor appears on the     computed tomography (CT) scan. Features of the tumor may include abnormal blood vessels and     areas in which tumor cells are dying. The samples that are taken during the needle biopsy     contain information from one small part of the tumor. The investigators believe that they can     show where in the tumor the samples came from, based on the CT scans during the biopsy     procedure. If the investigators can accurately determine where in the tumor their samples     came from, they can compare the features of that part of the tumor, as seen on the CT images,     to the features of that part of the tumor as seen under the microscope. This research study     also will give the investigators an idea of how much the biopsy samples are distorted in the     process of preparing them for examination under the microscope.   "
213567|NCT00639210|"     A Finnish Breast Cancer Group Study (BREX 01-2004). A multicenter phase III open randomised     trial of the efficacy of exercise in the prevention of long-term adverse effects of adjuvant     treatments and breast cancer recurrences in women with primary breast cancer. The aim of the     study is to investigate whether regular exercise training could reduce the long-term side     effects of adjuvant treatments of primary breast cancer and improve quality of life and well     being.   "
215309|NCT00668486|"     The purpose of this study is to prove the absence of photo irritation and photo sensitivity     potential of the product Dermacyd Breeze.   "
213525|NCT00638664|"     We are seeking volunteers to participate in a research study to determine the optimal imaging     parameters for visualization of the heart and its great vessels so that errors in computer     data analysis is minimized and clinical accuracy is maximized.      Participation in this study will involve having an MRI of the heart. This study will allow us     to determine the ability to measure the volumes of your heart chambers in both the left and     right side of your heart without using any aggressive (invasive) technique or the use of     ionizing radiation (x-rays or gamma rays). The study will also allow us to measure changes in     the cardiac chamber volumes during the cardiac cycle and determine whether this can be done     rapidly and accurately. The study will also allow us to determine whether this technique can     be used for routine clinical use.   "
213526|NCT00638677|"     Aims:        1. To develop a food supplement containing a health-promoting probiotic bacteria (B. lactis          BB12) and xylitol to be administered with a novel soft, possibly occlusion-friendly          pacifier.        2. Test in a clinical study how feasible the method is and to study how the intervention          affects caries occurrence.      Main hypothesis:      The administration of B. lactis BB12 and xylitol affects beneficially the dental health of     the child.   "
213527|NCT00638690|"     This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus     prednisone with placebo plus prednisone in patients with metastatic castration-resistant     prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the     previous chemotherapies must have contained docetaxel.   "
213528|NCT00638703|"     The main purpose of this study is to determine if Oxalobacter formigenes is effective at     lowering urinary oxalate levels in patients with primary hyperoxaluria.   "
213529|NCT00638716|"     This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study.      The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment     with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin     monotherapy.   "
213530|NCT00638729|"     alpha2-agonists like clonidine offer several useful effects that make these drugs an     interesting alternative to benzodiazepines for pharmacological premedication. We therefore     sought to determine the effect of pre-anesthetic medication with clonidine vs. midazolam in a     randomized, double-blind, placebo controlled study. Effects of pre-anesthetic medication were     assessed on (1) bispectral index (BIS),(2) sedation score and visual analog scales for     anxiety and pain, (3) neuropsychologic tests to assess cognitive function and (4) circulating     stress hormones.   "
213531|NCT00638742|"     To evaluate the steady-state systemic plasma concentrations of latanoprost acid following     administration of latanoprost 0.005% (1.5 ug) in pediatric and adult subjects with glaucoma     or ocular hypertension.   "
213532|NCT00638755|"     The purpose of this study is to evaluate the effect of nasal CO2 on nasal congestion and     other symptoms related to Perennial Allergic Rhinitis.   "
213533|NCT00638768|"     The aim of this pilot study was to determine the effect of physiotherapy on impairments and     health-related quality of life in people with a painful osteoporotic spinal fracture. It is     hypothesised that physiotherapy will reduce impairments and improve quality of life in this     patient group.   "
213534|NCT00638781|"     The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment     in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within     a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and     tolerability of 3 doses of desmoteplase compared with placebo with special consideration of     intracranial hemorrhage and major systemic bleedings.   "
213535|NCT00638794|"     Prospective, multicenter, registry of at least 11,000 (and up to 15,000) consecutive patients     with coronary artery disease undergoing stent-assisted percutaneous coronary intervention     (PCI) using DES without major procedural complications.   "
213536|NCT00638807|"     To compare the efficacy and safety of celecoxib versus placebo for the treatment of knee     osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and     ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen   "
213537|NCT00638820|"     We believe that hematopoietic stem cell transplantation (HSCT) will help subjects with     Osteopetrosis generate functioning osteoclasts, and by so doing assist in the resolution of     the abnormal bone architecture, and the anemia and bone marrow failure that is also     characteristic of this disease. However, we have found in past studies that approximately 30%     of Osteopetrosis patients do not engraft. Therefore, in this study, we plan to use a     different combination of pre-transplant drugs to try to make transplants safer for this     disease, as well as to provide a second infusion of stem cells in patients with matched     related or unrelated donors. The purpose of this research is to find a safer and more     effective means of performing stem cell transplantation in patients with Osteopetrosis, using     chemotherapy and radiation designed to bring about engraftment and lessen transplant     mortality.   "
213538|NCT00638833|"     To assess the efficacy of Memantine in improving the cognitive impairment in patients with     Multiple Sclerosis (MS)   "
213539|NCT00638846|"     Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked     (subject), daily wear, randomized, bilateral, parallel group study.   "
213540|NCT00638859|"     The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5-7     days in children with community-acquired pneumonia (CAP).      Secondary objectives are to assess Pharmacokinetics, Efficacy and Acceptability of     telithromycin 20 mg/kg qd for 5-7 days in children with CAP.   "
213541|NCT00638872|"     The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in     improving the healing of diabetic foot ulcers.   "
213542|NCT00638885|"     The purpose of this project is to measure brain markers and cognitive factors in twins with a     history of military service with and without PTSD, and to follow them over time and measure     changes in brain function and cognitive variables.   "
213568|NCT00639223|"     This study will examine the effect of red yeast rice extract compared to pravastatin on     muscle related complaints in individuals with high cholesterol who have previously been     unable to tolerate statin medications due to muscle pain. The study will determine whether     red yeast is associated with a lower level of muscle related complaints compared to     pravastatin.   "
213543|NCT00638898|"     RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the     growth of tumor cells by stopping them from dividing or killing them. Giving     colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the     blood so they can be collected and stored. Chemotherapy is then given to prepare the bone     marrow for the stem cell transplant. The stem cells are then returned to the patient to     replace the blood-forming cells that were destroyed by the chemotherapy.      PURPOSE: This clinical trial is studying how well giving busulfan, melphalan, and topotecan     hydrochloride together with a stem cell transplant works in treating patients with newly     diagnosed or relapsed solid tumor.   "
213544|NCT00638911|"     The aim of this therapeutic observation is to demonstrate the efficacy and safety of     telmisartan or telmisartan and HCTZ in the treatment of patients with mild-to-moderate     essential hypertension under normal conditions of use after market launch.   "
213545|NCT00638924|"     To analyze the alterations of physiologic variables in healthy sedentary women in the Shuttle     Walk Test, verify the distance reached and interruption causes of the test.   "
213546|NCT00638937|"     This phase II trial is studying how well saracatinib works in treating patients with     recurrent, stage IIIB or stage IV non-small cell lung cancer previously treated with     combination chemotherapy that included cisplatin or carboplatin. Saracatinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
213547|NCT00638950|"     The effects of n-3 LC-PUFA-supplemented dairy products on inflammation and immunological     parameters, biomarkers of oxidative stress, serum lipids, and disease activity were     determined in patients with rheumatoid arthritis (RA).   "
213548|NCT00638963|"     The purpose of this study is to determine whether temozolomide can be used as a prophylaxis     against brain recurrence in participants with metastatic breast cancer.   "
213549|NCT00638976|"     Randomized, blind controlled, Multicenter, spontaneous, prospective trial, roughly 20     enrolling centers in Italy, placebo and active drug supply given by GlaxoSmithKline (GSK).   "
213550|NCT00638989|"     To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous     administration compared with intravenous administration.   "
213551|NCT00639002|"     The purpose of this study was to determine clinical efficacy and safety of ruxolitinib     (INCB018424), a small molecule Janus kinase 2 (JAK2)-inhibitor, in patients with refractory     or relapsed multiple myeloma.   "
213552|NCT00639015|"     The present study was conducted as a prospective, randomized, controlled study to compare:        -  the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in          patients with catecholamine-dependent septic shock        -  to test the hypothesis that norepinephrine may likewise better preserve hepatosplanchnic          perfusion versus phenylephrine in patients suffering from septic shock   "
213553|NCT00639028|"     The aim of our study is to determine the most efficient radiologic examination to assess the     ankle sprain seriousness and so improve the therapeutic care.   "
213554|NCT00639041|"     The study was performed to investigate the effects of n-3 LC-PUFA supplemented dairy products     cardiovascular risk factors in hypertriglyceridemic patients.   "
213555|NCT00639054|"     Observational study investigating prognostic factors in newly diagnosed and relapsed multiple     myeloma patients by use of clinical data, biochemical markers (blood samples), cytogenetic     markers and gene expression profiling (myeloma cells from fresh bone marrow samples).     Enabling future genetic studies by establishing a biobank of bone marrow and peripheral blood     samples.   "
213556|NCT00639067|"     To demonstrate and validate a breath test for detection of early stage lung cancer that could     potentially reduce number of deaths.   "
213564|NCT00639171|"     Magnetic Resonance Spectroscopy (MRS) is a novel imaging technique for noninvasive probing of     biochemical properties of tissue. While MRS does not generate images of tumor per se it     allows biochemical spectroscopic data to be obtained in vivo from user defined     region-of-interest. In this manner, biochemical information elucidated by MRS can be     interpreted in relation to detailed anatomy and images of metabolite distribution can be     created. The aim of MRS is to identify presence and concentration of metabolites     characteristic for normal and abnormal (tumor) cellular activities hence allow differential     normal tissue from pathological tissue, as well as allow differentiating malignant from     benign tumors.   "
213787|NCT00651742|"     The purpose of this study is to determine whether S-1 is effective in slowing tumor activity     in patients with locally advanced or metastatic pancreatic cancer who have not had     chemotherapy. The study is also looking at the safety of S-1.   "
213557|NCT00639080|"     Purpose:      To assess prior need for lipid lowering therapy in patients with type 2 diabetes.      Background/Hypothesis:      At present, lipid lowering therapy, usually with a HMG-CoA reductase inhibitor or statin,     is recommended therapy for selected patients with type 2 diabetes mellitus (DM). The use of     statins for primary prevention of CVD is not clear. Some primary prevention studies have     found a statistically significant benefit but others have not (CARDS and ASPEN).      Although low-density lipoprotein (LDL) has traditionally been a key marker of cardiovascular     disease risk (CVD) risk and thus a guide to statin treatment, in recent years apolipoprotein     B (apoB) has emerged as an independent risk factor for CVD.      In a recent study, Tildesley H. et al. showed that in 500 patients with type 2 DM not on     lipid lowering therapy there was discordance between LDL and apoB values. Specifically, it     was found that among patients who fail to achieve the LDL-C target, 13% of men, 24% of women     less than 50 and 13% of women greater than 50 meet the apoB target. In other words, while the     LDL level would indicate treatment, the apoB level would not.      Objectives:      The investigators propose to measure lipid parameters during lipid lowering therapy and     compare this with lipid parameters at one and two months after discontinuation of therapy in     selected patients with type 2 DM at low risk for CVD. Lipid parameters to be measured     include: high-density lipoprotein (HDL) - cholesterol, LDL-cholesterol, triglycerides, total     cholesterol, total cholesterol: HDL-cholesterol ratio and apoB. As well, A1C will be     measured.   "
213691|NCT00650494|"     The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir     hydrochloride 1000 mg tablets to GSK's Valtrex® 1000 mg tablets following a single, oral 1000     mg (1 x 1000 mg) dose administration under fed conditions.   "
213558|NCT00639093|"     The investigators reported in a pilot study presented at last year's Cybertherapy Conference     (Girard & Turcotte, 2007) that using an action-cue exposure strategy in virtual reality     (ACE-VR; crushing virtual cigarettes) might be useful in the treatment of tobacco addiction.      The investigators are pursuing research in this area with a randomized control trial based on     90 smokers who will receive a brief psychosocial smoking cessation program (25 people are     enrolled so far and we expect to finish the study before the conference). During the first     four weeks of an eight-session psychoeducational and motivational program, all participants     will be immersed in VR. During the immersions in VR, 45 of the participants will use a     virtual arm to catch and crush virtual cigarettes. The other half of the sample will use the     virtual arm to catch virtual fruits (control condition).      The smoking frequency, and abstinence, will be assessed with a daily diary and exhaled carbon     monoxide tests (the CO2 tests will provide an objective confirmation of the abstinence     reported in the diaries). The success the program will be compared based on the number of     subjects who quitted or reduced their smoking frequency. The severity of addiction will be     assessed with two questionnaires, the Fagerstrom and the Horn tests. Craving and withdrawal     effects will be measured with the Minnesota Nicotine Withdrawal Scale (MNWS) and the Brief     Questionnaire of Smoking Urges (QSU-Brief) at the baseline and at the visits from weeks 1     through 4, 6, 12 and at the end of the program. Before the VR immersion, the Immersive     Tendencies Questionnaire will be administered and after each VR session participants will     fill two questionnaires addressing presence and cybersickness. The comparative impact of both     treatments will be tested with repeated measures ANOVAs (and planned contrasts) with     sufficient power to detect medium effect sizes.      The main goal of our study is show that crushing virtual cigarettes can boost the impact of a     behavioural program dedicated to cigarette addiction.   "
213559|NCT00639106|"     Following mastectomy (removal of your breast), reconstruction of your breast(s) can be     performed using tissue expanders and implants. At the same operation as your mastectomy, a     tissue expander is put under the skin and muscles of your chest.      Following your surgery, the tissue expander is gradually filled with salt water over a period     of months. Once the expander is filled to the size of your new breast, a second operation is     performed. At this time, the tissue expander is removed and a permanent breast implant is     placed. This is a standard procedure. We are interested in learning about the use of AlloDerm     in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in     order to cover and protect a tissue expander. We want to know if the use of AlloDerm can     decrease your pain or discomfort after surgery and after the filling of your tissue expander.      AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your     body to reject it are removed. When it is placed in your chest, your own cells will then grow     into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will     either have reconstruction with AlloDerm or without AlloDerm.   "
213560|NCT00639119|"     The progressive myoclonus epilepsy of the Unverricht-Lundborg disease (ULD) type is an     autosomal recessive disease characterized by progressive stimulus-sensitive and     action-related myoclonic jerks.      The mainstay of the current treatment in myoclonic epilepsies including ULD are valproic acid     and clonazepam among several other antiepileptic drugs. Unfortunately the disease may often     be resistant to antiepileptic drugs leading to major reductions in daily activities and     disability to walk without assistance. Therefore new treatment modalities are needed.     Experimental treatments of ULD patients with dopamine agonists have relieved myoclonic     symptoms. Further, in accordance with this, a recent study indicates decreased dopaminergic     neurotransmission in the basal ganglia of ULD patients, determined by PET.      The purpose of this study is to investigate the effect of dopaminergic medication (ropinirole     hydrochloride, Requip ®) on relieving the symptoms of ULD patients. Patients will undergo     sixteen weeks intervention period. The main efficacy determinants are changes in unified     myoclonus rating scale (UMRS), nerve conduction, multi-modality evoked potentials including     visual evoked potential (VEP), somatosensory evoked potential (SSEP) and brainstem auditory     evoked potential (BAEP), blink reflex habituation and electroencephalography (EEG).     Tolerability and the safety of the medication are determined. The study setting is placebo     controlled, crossover, two-group and double blind study.   "
213561|NCT00639132|"     There have not been longitudinal studies which track patients' neurologically or     developmentally in a systematic manner. By simultaneously tracking patients' neurodevelopment     along with neuroimaging and neurophysiologic studies it becomes much easier to draw     conclusions on the differential effects of the disease process and any available treatments     that patients might receive. In addition, many of the gene mutations, which cause MLD have     not been linked to the age of onset or the expected disease course.   "
213562|NCT00639145|"     The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated     by HIV-positive pregnant women and their infants in South Africa and Zambia.   "
213563|NCT00639158|"     The primary purpose of this study is to compare the safety and efficacy of ABT-335     (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin     coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.   "
213576|NCT00639327|"     The purpose of this study is compare overall survival of the test arm (CPT-11/S-1     combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced     gastric cancer.   "
213577|NCT00639353|"     This study seeks to evaluate the clinical performance of a recently released contact lens     designed to correct astigmatism to an established contact lens that has historically been     used in these patients.   "
213565|NCT00639184|"     We plan to test a home-based parent-provided early developmental intervention (EI) both in     infants with mild to moderate birth asphyxia and in infants without perinatal complications     who will constitute a healthy comparison group in a randomized controlled trial. The trial     will evaluate the effect of a resource-intensive early intervention (EI) program on the     outcomes in infants born in rural communities in Zambia, India, and Pakistan. It will consist     of frequent interaction (every 2 weeks the first year and every 4 weeks the second and third     years) between parents and the parent trainer. The control group will receive enhanced health     counseling (HC).      The overall goal will be to implement and evaluate an EI program for infants following birth     asphyxia, which is sustainable in developing countries. The challenge will be to adapt     programs demonstrated to be effective in developed countries to the circumstances of the     developing world, while reducing the demands on resources. Because there are limited data on     normative development and EI programs in developing countries, a group of infants without     perinatal complications will also be randomized to the same conditions in order to provide a     comparison of what may be achieved from the intervention in healthy infants in developing     countries. A final aim will be to address individual variation in EI effects that could be     due to child and/or family characteristics.      A randomized controlled experimental design will be used, in which infants who survive     following birth asphyxia are randomly assigned to either EI or enhanced health education     counseling (HC). The trial will randomize infants to a home-based parent-provided early     developmental intervention (EI) with frequent home interaction between parents and parent     trainers vs. HC. A group of infants without birth asphyxia or other major perinatal     complications also will be randomized. Children will be examined by masked examiners at three     time points (12, 24, and 36 month's assessments).   "
213566|NCT00639197|"     The purpose of the study is to determine if tunneling standard short-term central lines for a     short distance under the skin, with the assistance of ultrasound imaging, reduces the risk of     central line infections for catheters placed in the neck vein.      Previous work has shown that these lines can be tunneled without ultrasound guidance. We wish     to determine if the use of ultrasound makes the tunneling procedure safer and easier.   "
213569|NCT00639236|"     The use of inhaled hypertonic saline has been extensively documented in asthma,     bronchiectasis, cystic fibrosis and COPD as method of bronchial challenge and sputum     induction, but studies that evaluated others endpoints are required. The objective of this     study was to analyse the effects of inhaling hypertonic saline compared with placebo with     respect to functional exercise capacity, dyspnoea and quality of life. In a double-blind     randomised parallel placebo-controlled trial, conducted at the Clínicas Integradas of the     Evangelical Faculty of Paraná,sixty-eight patients (age 67 ± 6.5 years; FEV1 38.9 ± 16.2     predicted) were randomised to inhale 3% hypertonic saline (n=34) or placebo (n=34), combined     with a program of exercise, three times a week, for 8-weeks.   "
213570|NCT00639249|"     The purpose of this study is to evaluate the safety and tolerability of SA4503 in patients     recovering from a recent stroke. Secondary, to evaluate the efficacy of SA4503 compared to     placebo.   "
213571|NCT00639262|"     Sorafenib™ has the potential to inhibit tumor growth, tumor angiogenesis , and enhance     radiation response. This study will test the combination of Sorafenib™ and radiation therapy     with or without temozolomide to determine tolerance of the combined treatments. Defining safe     dosing of Sorafenib™ in this combination therapy will be achieved.   "
213572|NCT00639275|"     Patients with Parkinson's disease (PD) frequently experience upper gastrointestinal     disorders. During the disease, weight loss is often noticed. Recently, many studies have     demonstrated that STN-DBS improved extrapyramidal symptoms. Interestingly, PD patients gain     weight after STN-DBS, at least in part due to a decrease in resting energy expenditure.      Purpose: To evaluate benefits of STN-DBS on upper gastrointestinal symptoms and motility.      Patients et method: PD patients waiting for STN-DBS, will be assessed in a preoperative time     (2 times at, at least, 3 month intervals, to evaluate the natural history of the disease on     upper gastrointestinal symptoms and motility) and in a postoperative time, after 6 months of     chronic STN-DBS. Each assessment will include : 1/ questionnaires about frequency and     severity of upper gastrointestinal symptoms; 2/ a nutritional assessment (body mass index,     dietary assessment); 3/ the gastric emptying measurement with the 13C-octanoic acid breath     test; 4/ the colorectal transit time measurement with radio-opaque markers 5/ an indirect     calorimetry to estimate resting energy expenditure; 6/ and plasmatic leptin and ghrelin     concentrations, hormones involved in the homeostatic regulation of appetite.      Perspectives: This physiopathological study should allow us to understand the mechanisms of     the effects of STN-DBS on upper gastrointestinal symptoms and weight regulation in PD     patients.   "
213573|NCT00639288|"     Objective: To develop a detailed treatment manual that modifies the existing CPT-C treatment     protocol to allow for concurrent treatment of PTSD and AD, and to obtain some pilot data     regarding its efficacy.      Hypothesis: We predict that CPT-C will significantly reduce the number of drinking days     (measured by the Timeline Follow Back Method [TLFB]) and reduce the symptoms of PTSD     (measured by the [CAPS and PCL] scores).      Design: This is a non-randomized, prospective study in which all participants will receive     the modified CPT-C for 12 weeks by trained CPT-C clinicians, with each session lasting     approximately 1-1.5 hours). Modifications to CPT-C include psychoeducation about alcohol use     as an avoidance of PTSD symptoms integrated throughout treatment, integration of coping     skills training for AD, weekly breathalyzer tests to measure blood alcohol level, and use and     collection of daily dairies of alcohol use.   "
213574|NCT00639301|"     The purpose of this study is to find out about the quality of life and health in a group of     adults who had retinoblastoma when they were children. By quality of life, we mean how you     are feeling about being satisfied with things in your life, including your physical health,     your emotional health, and your ability to carry out daily activities. We hope that this     information will help us provide better care to future children with retinoblastoma and     better follow-up care for survivors of retinoblastoma.   "
213575|NCT00639314|"     The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed     gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life     (QOL).   "
242767|NCT01033318|"     The goal of this study is to identify at least one safe and well tolerated dose of MK1809     that has similar pharmacokinetic qualities as 100 mg losartan.   "
213578|NCT00639366|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known     whether radiation therapy directed at the head is effective in preventing brain metastases in     patients with advanced cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy to the head to see how     well it works in preventing brain metastases in women receiving trastuzumab and chemotherapy     for metastatic or locally advanced breast cancer.   "
213579|NCT00639379|"     The purpose of this study is to evaluate and compare the clinical performance of two toric     contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized,     bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance     of the test lens over the control lenses for comfort, vision, and toric fit characteristics     as well as corneal integrity   "
213580|NCT00639392|"     The long-term goal of this study is to learn if Zoledronic Acid can prevent or reduce pain in     sickle cell disease. The goal of this study is to learn about the safety of Zoledronic Acid     in persons with sickle cell disease who experience chronic pain requiring medical treatment     or use of narcotics.   "
213581|NCT00639405|"     The purpose of this study is to design a method to better localize parathyroid adenomas. This     study will include approximately 6 patients who have not had surgery and another 25 patients     who have already had surgery over the course of one year.   "
213582|NCT00639418|"     The purpose of this study is to describe flu vaccine coverage in children under 18 years of     age and to examine correlations between in-office flu vaccine coverage and the use of various     tactics to increase vaccine coverage.   "
213659|NCT00648037|"     The purpose of this study is to determine if we can prevent Epstein Barr Virus lymphomas by     the monthly administration of an (antibody) protein against B lymphocytes called Rituximab.     Although this medicine has been approved by the Food and Drug Administration to treat     patients with other types of lymphomas, and has been used to treat a small number of patients     with EBV lymphomas and other types of B-cell leukemias, it has not been approved to try and     prevent EBV-lymphomas. Use of Rituximab to try to prevent EBV-lymphomas is therefore     experimental.   "
213583|NCT00639431|"     Because bilateral lower extremity amputees do not have an intact limb for use with the     mirror, we are now proposing to conduct a pilot trial of two treatments for phantom limb pain     (PLP) - direct observation of another person's foot moving versus mental visualization. The     trial will last for 4 months and during the first month data will be gathered daily on the     number of episodes of phantom limb pain, the average length of episodes, and the average     intensity of pain in each phantom leg. In addition, the rapidity of pain relief, the length     of therapy needed to sustain long-lasting pain relief, and whether use of these two treatment     methods during rehabilitation can provide sustained and/or permanent pain relief will be     determined. This study will test the hypothesis that direct observation of a limb while     performing phantom limb movements will reduce phantom limb pain more than mental     visualization of the phantom limb alone in subjects who have sustained a traumatic bilateral     lower limb amputation.   "
213584|NCT00639444|"     The purpose of this study is to determine whether age at introduction of gluten-containing     cereals (e.g. wheat) plays a role in influencing the risk of celiac disease (CD) development     in infants with a first-degree relative affected by CD.   "
213585|NCT00639457|"     The purpose is to examine the safety and efficacy of 16wks of pioglitazone (Actos; 30mg/d)     with and without aerobic and strength exercise training for reducing glucose intolerance and     central adiposity in HIV-infected people. We anticipate that pioglitazone + exercise training     will improve glucose metabolism and insulin sensitivity, and reduce central adiposity more     than pioglitazone alone. These improvements should translate into reduced cardiovascular     disease risk in HIV-infected people.   "
213586|NCT00639470|"     The objective of this study is to test legal guardians reading comprehension of their child's     post-operative medication administration using three different versions of written medication     information (standard fact sheets, easy-to-read fact sheets, and easy-to-read fact sheets     accompanied by illustrations).   "
213587|NCT00639483|"     To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus     risperidone alone in patients with schizophrenia   "
213588|NCT00639496|"     The purpose of this study is to determine whether NAC added to prednisone, and azathioprine     has a better effect on lung function, radiology and clinical condition than placebo +     prednisone in combination with azathioprine after 6 and 12 months.   "
213589|NCT00639509|"     This phase II trial is studying how well IMC-A12 works in treating patients with advanced     liver cancer. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them.   "
213590|NCT00639522|"     The purpose of this study is to investigate the maximum tolerated dose and pharmacokinetics     of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced     gastric carcinoma.   "
213591|NCT00639535|"     This is a study looking at advanced imaging such as PET/CT and MRI to see if they can provide     a more accurate assessment of the patient with dense breasts or difficult to interpret     mammograms. In addition, the ability to determine whether one or the other is more accurate     or whether both together would be appropriate in this clinical situation, may be able to be     measured.      The MRI studies are very sensitive for detection of breast histopathology but less specific     in differentiating between small low grade malignancies are more benign pathologies.     Multifocal pathology can be challenging in determining site(s) for biopsy.      PET scanning is specific in the measurement of metabolic glucose activity of various     histopathologies and is accurate in differentiating aggressive from benign pathology in     multifocal breast disease. A further drawback of PET is the lack of ability to observe     lesions less than 3-4mm in diameter.      In select cases the combination of MR and PET/CT is able to come to a more conclusive     diagnosis - specifically with bilateral or multifocal breast disease.   "
213620|NCT00639925|"     The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402     restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination     with gemcitabine   "
213621|NCT00639938|"     The increase in pediatric HIV infection has a substantial impact on childhood mortality in     the developing world. A number of recent studies suggest that as many as half or more of     mother-to-child HIV transmissions in developing countries occur in late pregnancy or during     labor and delivery. Interventions targeted during the perinatal period have shown to be     effective and to have a significant impact in reducing transmission. The purpose of this     study is to investigate the effectiveness of nevirapine (NVP) plus immunoprophylaxis or     extended NVP dosing regimens in HIV-infected pregnant women and their infants during the     perinatal period.   "
215730|NCT00673465|"     The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and     to determine the influence of race/ethnic origin on therapeutic response.   "
213592|NCT00639548|"     Most critically ill patients receive sedative and analgesic drugs to attenuate discomfort and     pain. The excessive use of sedatives and analgesics has undesirable effects for patients.     Whereas undersedation is mostly easy to identify, oversedation with its associated problems     is more difficult to recognize. Stopping sedation daily helps to avoid gross oversedation,     but this is not always possible. Monitoring the depth of sedation is difficult and is     currently based on clinical assessment and the use of clinical scoring systems. These scoring     systems cannot be applied continuously, they are subjective and the level of consciousness     can be altered when sedation is assessed.      Several methods based on the electroencephalogram have been tested to avoid these problems,     but the results have been disappointing so far, so the BIS Monitor an dthe Entropy monitor.We     have previously shown that the time-locked cortical response to standard external stimuli     (long-latency auditory evoked potentials or event-related potentials; ERPs) can discriminate     between clinically relevant light to moderate and deep sedation levels in healthy volunteers,     when sedation is induced with a combination of propofol or midazolam with remifentanil.      We therefore hypothesized that ERPs may be used to monitor the depth of sedation in ICU     patients as well. As the first step to test this hypothesis, we evaluated the use of ERPs to     assess the level of sedation in patients undergoing elective major surgery and admitted to     the ICU for short term postoperative mechanical ventilation.   "
213593|NCT00639561|"     The main objective of the study is to realized a collection of feces in order to study the     modification of the intestinal microflora according to alimentary fibres   "
213594|NCT00639574|"     The administration of néfopam after initial treatment by kétoproféne, could obtain, in     patients remaining pain and classically need morphine, analgesia at least the same as     morphine alone. The use of néfopam second line after ketoprofen could reducing (or even     eliminating) the need for morphine (and its side effects), allowing a reduction in the length     of stay of patients in the emergency unit.      The main objective is to show that the addition of a néfopam initial treatment with the     kétoproféne, reduces, in patients with ureteral calculi, the percentage of patients requiring     the use of a treatment by morphine.      The secondary objective is to reduce the side effects caused by the morphine, shorten the     time to install the appropriate level of analgesia while reducing the risk of failure of the     titration morphine, reduce the time spent on titration of morphine and reduce the length of     stay patient intake in emergency unit.   "
213595|NCT00639587|"     Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in     Japan. The objective of the study was to compare the efficacy and safety of cetirizine     hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial     allergic rhinitis.   "
213596|NCT00639600|"     This research project is supported by a multicentric network of collaborators whose goal is     to assess the efficacy of transplanting allogenic pancreas islets to restore insulin     secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney     transplantation and to improve their metabolic control.   "
213597|NCT00639613|"     The purpose of this study is to determine whether excessive secretion of glucagon in type 2     diabetes originates from the pancreatic alpha-cells or endocrine cells in the mucosa of the     small intestinal.   "
213598|NCT00639626|"     This is a study to find out if Levemir® (a long acting or basal insulin) is safe and     effective in treating cystic fibrosis related diabetes (CFRD).   "
213599|NCT00639639|"     RATIONALE: Vaccines may help the body build an effective immune response to kill cancer     cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy     together with radiation therapy and chemotherapy may kill more cancer cells.      PURPOSE: This randomized phase I/II trial is studying how well vaccine therapy works in     treating patients with newly diagnosed glioblastoma multiforme recovering from lymphopenia     caused by temozolomide.   "
213600|NCT00639652|"     Currently, we conduct a prospective, randomized trial comparing the outcome of surgical     excision with the outcome of curettage in nodular and superficial BCCs. Larger BCCs and     micronodular or sclerosing BCCs are not included in the randomized study. They are mainly     operated using three-dimensional histology (3D-histology, micrographic surgery). In this     observational study we measure the cosmetic result and the recurrence rate of all BCCs not     included in the randomized trial.   "
213601|NCT00639665|"     Observing how cocoa effects the cardiovascular and renal system.   "
213602|NCT00639678|"     To evaluate the safety and tolerability of raxibacumab in healthy subjects.   "
213603|NCT00639691|"     This study has the objective of providing compassionate use access to omalizumab (Xolair) and     to evaluate the Safety of Xolair in subjects with severe allergic asthma who remain     symptomatic despite optimal therapy according to GINA step 4 treatment guidelines.   "
213604|NCT00639704|"     The purpose of this study is to compare the MRI results with the new SPECT image     reconstruction method, this study will allow us to determine whether a new more accurate     method of looking at the heart by nuclear study can be used in routine clinical use.   "
213622|NCT00639951|"     The purpose of this study is to compare whether a same total dose given up front as a single     dose is more effective and as safe as the same dose given as a fractioned dose.      Evaluate the Utility of the the Dry Tube Test Evaluating its Correlation with Coagulation     Test Results (fibrinogen, platelets, INR, PT and PTT).      Explore the Evolution of some Serum Markers (CK, DHL, metalloproteinase), Amount of Venom and     Antivenom Levels and the Progression of Local Lesions.   "
213645|NCT00640250|"     We propose a prospective, multi-center, double-blind, randomized study comparing the     diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue     106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a     clinical history of contact dermatitis and a positive patch test (current or previous) to the     corresponding reference petrolatum allergen (sensitives).   "
213683|NCT00650390|"     The study was to explore the efficacy of adalimumab in subjects previously treated with     infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore     the safety of adalimumab in subjects previously treated with infliximab.   "
244519|NCT01055964|"     The aim of this study is to identify the pharmacokinetic differences between two oral forms     of Tacrolimus and consequent nephrotoxicity.   "
213605|NCT00639717|"     This research study investigates the benefits and possible risks of adding both etanercept     (Enbrel) and ECP (extracorporeal photopheresis) to the conventional preventative (or     prophylactic) treatments for graft-versus-host disease (GVHD). GVHD is a common, serious, and     too often fatal, complication after matched unrelated donor stem cell transplantation,     regardless of the pre-transplant conditioning regimen used (full or reduced intensity).      Reduced intensity transplants which employ lower doses of chemotherapy during the     conditioning phase of the transplant, are less toxic than full intensity transplants. Reduced     intensity transplants may extend the unrelated donor transplant option to older patients or     to patients with existing medical conditions or illness, where a full intensity transplant is     not possible. To be successful, reduced intensity transplants need to offset any lower     effectiveness in killing cancer cells during the conditioning phase, with the establishment     of a donor cell, graft-versus-leukemia effect (GVL). The GVL effect and GVHD are associated     with each other and therefore, the goal of GVHD prophylaxis for this study is not so much to     prevent all GVHD, but rather to prevent serious and fatal acute GVHD.      Most GVHD-related deaths are either the direct consequence of severe GVHD or from infections     associated with intense immunosuppression, a consequence of the standard treatments for acute     GVHD, which almost always include high-dose steroids. A more effective prophylaxis therapy     that allows for the GVL effect to develop, while limiting the exposure to high-dose steroids     may reduce transplant mortality and morbidity. We also will study how key chemical and     cellular factors relate to clinical outcome.   "
213606|NCT00639730|"     This research is being done to find out if the Atkins Diet can be used safely and effectively     to reduce seizures in children who have Sturge Weber syndrome.      The ketogenic diet is a proven therapy for epilepsy, but can be difficult to use in children.     The Atkins Diet is a high fat, high protein, low carbohydrate diet introduced in the 1970s to     help with weight loss. It is different from the ketogenic diet in four major ways: no calorie     restriction, no fluid restriction, no protein restriction, and is easy to start outside the     hospital. People on the Atkins Diet become ketotic (produce high levels of ketones, a certain     substance in the body), like patients on the ketogenic diet, and the investigators believe     this may lead to seizure control.      Children aged 2-18 with Sturge Weber syndrome and seizures at least monthly, who have used at     least two anti-seizure drugs may join. 5 children in total will be enrolled.   "
213607|NCT00639743|"     Heparin is the reference therapy for most patients with pulmonary embolism. Some patients     with sub-massive pulmonary embolism defined by normal blood pressure and dysfunction of the     right ventricle have a higher mortality risk. It has been suggested that thrombolytic     treatment, a drug that dissolves blood clots more rapidly, may reduce the mortality in those     patients. The studies reported to date were unable to confirm or refute this hypothesis     because the number of patients included in those studies is too low. The aim of the study is     to compare thrombolytic treatment with heparin (which is the reference therapy for pulmonary     embolism) in a large group of patients with sub-massive pulmonary embolism.   "
213608|NCT00639756|"     Studies in animals have found that allopurinol can markedly improve fructose induced     metabolic syndrome. In this study we test the hypothesis that allopurinol may lower BP,     reduce triglycerides, and improve metabolic parameters in subjects placed on a high fructose     diet.   "
213609|NCT00639769|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating     recurrent or metastatic head and neck cancer.   "
213610|NCT00639782|"     The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is     reduced as compared to the SJM prosthesis.   "
213611|NCT00639795|"     The purpose of this study is to compare:        1. The degree of systemic postoperative inflammation (cytokine measurement) with the degree          of post-operative pain        2. The degree of pain and nausea and        3. The pre and post operative pulmonary functions      following Video Assisted Thorascopic Surgery (VATS) performed under general anesthesia with     the addition of intra-operative single-injection paravertebral blockade vs general anesthesia     with a sham intra-operative paravertebral nerve blockade   "
213612|NCT00639808|"     The purpose of this study is to determine whether TZP-101 is safe in people with diabetes.     Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic     patients.   "
213613|NCT00639821|"     This study investigated the mucosal gene expression defects associated with active Crohn's     disease (CD)and ulcerative colitis (UC), and studied the effect of infliximab induced     downregulation of inflammation and mucosal healing on these abnormalities, using whole genome     gene expression microarrays.   "
213614|NCT00639834|"     The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate     is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in     the severity patients' arthritis will also be analysed.   "
213615|NCT00639847|"     This study compared an in-home asthma management program provided by nurses or respiratory     therapists to see if those receiving program had fewer hospitalizations, clinic and emergency     room visits and higher levels of satisfaction and health related quality of life.   "
213616|NCT00639860|"     The purpose of this study is to evaluate clinically, histologically and radiographically the     healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12     weeks following exodontia.   "
213617|NCT00639873|"     A randomized, controlled clinical trial conducted in Southeastern Bangladesh using artesunate     monotherapy to determine the baseline sensitivity of P. falciparum to artemisinins.   "
213618|NCT00639899|"     In varicocele the venous pressure in the prostatic bed is increased .This may result in     raised hydrostatic pressure which in turn may stimulate prostatic hypertrophy.      Restoring normal venous drainage is expected to lower hydrostatic pressure followed by     inhibition of prostatic growth and possibly leading regression in prostatic dimensions.   "
213619|NCT00639912|"     The aim of the study is to test the efficacy of low versus high volume hydration and two     different solutions (sodium chloride versus sodium bicarbonate) in preventing contrast     induced nephropathy (CIN) in ST elevation myocardial infarction (STEMI) patients undergoing     primary PCI.   "
213623|NCT00639964|"     Justification:      Intrauterine exposure to type 1 or type 2 diabetes increase the risk of macrosomia (35 % to     50 % versus 10 % in general population) despite a good glycemic control. The consequences are     : shoulder's dystocia, lung immaturity, caesarean section, neonatal hypoglycaemia and a high     frequency of obesity and metabolic disorders in adults.      The mechanisms of macrosomia are unclear; chronic hyperglycemia and subsequent     hyperinsulinaemia observed during the diabetic pregnancy might explain only partially the     fetal weight. Considerable interest has been generated over the last decade on the lipids and     fatty acids alterations in diabetes pregnancies. Change in lipoproteins metabolism have been     described associated with macrosomia. Maternal nutrition before and during pregnancy plays an     important role in fetal growth and subsequent development of an increased susceptibility to     obesity and diabetes in later life.      Main objective:      Looking for an association between maternal and fetal blood lipid parameters and birth weight     and body fat in a context of type 1 or type 2 diabetes.      Secondary objectives:        -  Identify lipid markers associated with fetal macrosomia.        -  Analyze the placenta by measuring the expression of genes implicated in the storage and          the transfer of fatty acids.        -  Analyze and compare the expression level of placental genes subjected to parental          imprinting and validated in animal models.   "
213660|NCT00648050|"     The objective for this study was to investigate the bioequivalence of Mylan's verapamil HCl     extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules     following evening administration of a single, oral 300 mg (1 x 300 mg) dose administration     under fasting conditions.   "
213624|NCT00639977|"     To evaluate the short-term effect of acupuncture on the intraocular pressure (IOP).      Methods: A randomized controlled trial. Healthy volunteers will be randomly allocated to     three groups: Acupuncture group - will be submitted to a 20-minute session of acupuncture     with needles inserted in specific points (Tong Zi Liao, Yang Bai and Jing Ming); Sham group -     will be submitted to a 20- minute session of acupuncture with needles inserted in false     points located 1 cm from true points in areas without acupuncture's meridians; and Control     group - no intervention. IOP measurement by a masked investigator using Goldmann applanation     tonometry immediately before the intervention, as well as 30 minutes and 24 hours after the     acupuncture.   "
213625|NCT00639990|"     The hypothesis is that brain injury patients have alterations of the respiratory system     related to intraabdominal pressure. Furthermore application of moderate levels of PEEP may     improve respiratory function in these patients.   "
213626|NCT00640003|"     This research is being done to find out if Baclofen, a medicine that is often used for the     treatment of abnormal stiffness, might also be useful to treat some of the neurologic     problems caused by ataxia telangiectasia (A-T). The investigators also want to find out if     there are better ways to measure the problems of ataxia and abnormal eye movement for future     studies of medication in ataxia telangiectasia.   "
213627|NCT00640016|"     To investigate the effects of CAT-354 on airway hyper-responsiveness (AHR) in uncontrolled     asthma.   "
213628|NCT00640029|"     Until now, arthrodesis (intervertebral fusion) is the formal treatment for the lumbar and     cervical degenerative disc disease : arthrodesis has been the standard surgical treatment for     the patients when nonsurgical management has failed. However , it has shown out some     drawbacks : pseudoarthrosis may appear in the short term, and junctional degeneration in the     long term.      The replacement of the intervertebral disc by a prosthesis (arthroplasty) has been since a     few years a major alternative therapeutic to the arthrodesis.: it demonstrates great     functional results and less post-interventional complications. It is indicated to restore a     normal function of the spine (motion is kept)and to avoid deterioration of the adjacent     spinal segments over the long time.      In this clinical study, we will distinguish the cervical discal pathology and the lumbar     discal pathology.      The purpose of this study is to analyze the results of the arthroplasty in terms of     functional effects, quality of life, anatomical results and economical results.   "
213629|NCT00640042|"     The purpose of this study is to provide information in a broad, real world population of     chronic pain patients assessing both pain control with AVINZA as well as the potential risk     for misuse and abuse.   "
213630|NCT00640055|"     The NICHD Global Network (GN) for Women's and Children's Health Research, a multi-site,     international research network, provides a unique infrastructure to implement an expanded     perinatal verbal autopsy study using the FIRST BREATH trial as its platform. The FIRST BREATH     trial is an ongoing study of neonatal resuscitation training in rural community settings     within Global Network sites in Central Africa, Asia and Latin America.      This study uses a validated VA questionnaire to determine COD of stillbirths and early     neonatal deaths among participants in the FIRST BREATH study. We propose to expand the     usefulness of perinatal verbal autopsy methodology in two ways. First by assessing whether     the Community Coordinator (a non-physician health worker) can assign COD with a high level of     concordance comparable to a Physician Panel, and second, whether the FIRST BREATH Birth     Attendant can provide as reliable perinatal information as the mother during the VA     interview. Our primary hypothesis is that the COD assigned by the FIRST BREATH Community     Coordinator will be the same as the COD assigned by the Physician Panel in greater than 70%     of early neonatal deaths (ENDs), when both use the same VA and FIRST BREATH data.   "
213631|NCT00640068|"     The ACIC is a Collaborative Quality Improvement (CQI) program involving the collection of     data related to: indications for Coronary Computed Tomography (CCTA), patient health     characteristics, acquisition techniques of CCTA scans, physician interpretation of results     and short-term outcomes over a 90 day period.   "
213632|NCT00640081|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor     cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. It is not yet known whether giving combination chemotherapy together with     intermittent cetuximab is more effective than combination chemotherapy given together with     continuous cetuximab in treating colorectal cancer.      PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together     with intermittent cetuximab to see how well it works compared to combination chemotherapy     given together with continuous cetuximab as first-line therapy in treating patients with     advanced or metastatic colorectal cancer.   "
213643|NCT00640224|"     The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl     estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory     markers, vascular markers and bone development in overweight adolescent females with     polycystic ovary syndrome (PCOS).   "
213661|NCT00648063|"     The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg     tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose     administered under fasting conditions.   "
213662|NCT00648076|"     The objective of this study was to investigate the bioequivalence of Mylan's divalproex     sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a     single, oral 500 mg (1 x 500 mg) dose administered under fed conditions.   "
213663|NCT00648089|"     EPOMI is a randomized, open-label, parallel phase II clinical study that will evaluate the     effects of a single erythropoietin administration on infarct size and cardiac remodeling in     patients with acute myocardial infarction. Eligible patients will be randomly assigned to     receive conventional therapy and single infusion of 1000U/kg of epoetin beta or conventional     therapy alone. Infarct size and cardiac remodeling parameters will be assessed by cardiac     magnetic resonance imaging (MRI) within 3-7 days of the randomization and repeated 3 months     later.   "
213725|NCT00650936|"     The purpose of this study is to prospectively evaluate the incidence of hemodynamic     compromise and to obtain long-term survival data on patients with the AMPLATZER Septal     Occluder   "
213633|NCT00640094|"     Background: Experimental studies have documented the beneficial effects of the endogenously     produced antioxidant, melatonin, in reducing tissue damage and limiting cardiac     pathophysiology in models of experimental ischemia-reperfusion. Melatonin confers     cardioprotection against ischemia-reperfusion injury most likely through its direct free     radical scavenging activities and its indirect actions in stimulating antioxidant enzymes.     These actions of melatonin permit it to reduce molecular damage and limit infarct size in     experimental models of transient ischemia and subsequent reperfusion.      Study design: The Melatonin Adjunct in the acute myocaRdial Infarction treated with     Angioplasty (MARIA) trial is a prospective, randomized, double-blind, placebo-controlled,     phase 2 study of the intravenous administration of melatonin. The primary efficacy end point     of this study is to determine whether melatonin treatment reduces infarct size determined by     cardiac magnetic resonance 5-7 days post-reperfusion. Other secondary end points will be the     clinical events occurring within the first year: death, sustained ventricular arrhythmias,     resuscitation from cardiac arrest, cardiogenic shock, heart failure, major bleedings ,     stroke, need for revascularization, recurrent ischemia, re-infarctions and rehospitalization;     and changes in left ventricular ejection fraction from baseline to 4 months of follow-up.      Implications: The MARIA trial tests a novel pharmacologic agent, melatonin, in patients with     acute myocardial infarction and the hypothesis that it will confer cardioprotection against     ischemia-reperfusion injury. If successful, the finding would support the use of melatonin in     therapy of ischemic-reperfusion injury of the heart.   "
213634|NCT00640107|"     Magnetic Resonance Imaging (MRI) is a non-invasive diagnostic imaging technology that     produces images of the body. This technology does not utilize radiation, as does Computed     Tomography (CT) but relies on radio waves and a strong magnet to produce images.      The purpose of this study is to evaluate new commercially available MR imaging sequence     and/or hardware that have been installed on an existing MR unit or to evaluate a new MR unit.     The study also serves to familiarize the MR technical staff with how to operate the new     equipment. The information obtained will be used to optimize new MR equipment that has been     installed on the MR scanner   "
213635|NCT00640120|"     The WIM-PC™ device, indicated for acoustic pulmonary function measurement that quantifies the     presence of wheezing. This study was designed in order to evaluate the efficacy and safety of     using the WIM-PC™ device for wheeze detection during dynamic bronchial situations in infants     that were hospitalized as a result of asthmatic attack.   "
213636|NCT00640133|"     This study will evaluate the safety and effectiveness of deep brain stimulation in treating     people with severe and otherwise treatment-resistant obsessive-compulsive disorder.   "
213637|NCT00640146|"     The purpose of this study is to examine the safety and activity of MNTX in relieving     opioid-induced constipation following orthopedic procedures.   "
213638|NCT00640159|"     Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is     primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction     with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations     for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in     the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B     (MAO-B) activity is generally considered to be of primary importance.      Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg     daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of     selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in     the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and     avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a     lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no     empirical data indicating whether the use of the new approved formulation of selegiline ODT     (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is     believed that clinical efficacy will be preserved or enhanced, by delivering more active     drug, with improved patient preference for the ODT formulation due to the once-daily dosing .      The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in     the treatment of PD was established in a multicenter randomized placebo-controlled trial     (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months'     duration. Patients randomized to orally disintegrating selegiline received a daily dose of     1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were     all treated with levodopa and could additionally have been on dopamine agonists,     anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks,     orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less     OFF time compared to baseline. Placebo treated patients had 0.6 hours per day less OFF     time compared to baseline. These differences were significant (p < 0.001). Adverse events     were very similar between drug and placebo.   "
213639|NCT00640172|"     Eligible elderly men and women with anemia will undergo a full hematologic evaluation plus     additional laboratory tests to determine the etiology of the anemia. In a subset of subjects,     bone marrow aspirate and biopsies will be obtained for a planned analysis of erythroid     progenitor and stem cells. Plasma; serum; and bone marrow samples will be will be compared to     elderly non-anemic controls. Bone marrow samples will also be compared to non-anemic young     controls (purchased).   "
213640|NCT00640185|"     The purpose of this study is to test if the investigational medication ABT-089 is a safe and     effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).   "
213641|NCT00640198|"     -  Aphasia, the loss or impairment of language caused by brain damage, is one of the most          devastating cognitive impairments of stroke. Aphasia can be treated with combination of          speech-language therapy and drugs. Conventional speech-language therapy in chronic          aphasic subjects is of little help and several drugs have been studied with limited          success. Therefore other therapeutic strategies are warranted.        -  Recent data suggest that drugs (memantine) acting on the brain chemical glutamate may          help the recovery of cognitive deficits, included language, in subjects with vascular          dementia. The present study examines the safety profile and efficacy of memantine paired          with intensive language therapy in subjects with stroke-related chronic aphasia (more          than 1 yr. of evolution).   "
213642|NCT00640211|"     This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as     prophylaxis against pandemic influenza infection in patients who are prescribed a long term     course in the context of a place of employment or profession. The study is observational     only. The primary measure used in this study will be the incidence of symptomatic pandemic     influenza in patients receiving prophylaxis. Seroconversion to pandemic influenza, the     incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir     prophylaxis will also be examined. This project will commence upon pandemic influenza being     declared in Australia, Hong Kong or Singapore. Data will be analysed as quickly as possible     to help inform the continued use of neuraminidase inhibitor therapy as a cornerstone of the     public health agency response to pandemic influenza.   "
213646|NCT00640263|"     The ANRS 12174 study is a clinical trial that will compare the efficacy and safety of     prolonged infant peri-exposure prophylaxis (PEP) with Lopinavir/Ritonavir (LPV/r) versus     Lamivudine to prevent HIV-1 transmission through breast milk in children born to     HIV-1-infected mothers not eligible for HAART and having benefited from perinatal     antiretroviral (ART) regimens. The study will recruit 1500 mother-infant pairs in 4 African     countries.      Study design:      PROMISE PEP is a multinational, randomised double-blind controlled clinical trial.      Intervention:      Infants will be randomised to receive LPV/r or 3TC twice daily from day seven (± 2 days)     after birth until 4 weeks after cessation of breastfeeding (BF). We will recommend exclusive     BF (EBF) up till including the 26th week of life followed by a relatively rapid (maximum of 8     weeks) cessation period. The maximum duration of PEP will thereby be 38 weeks.      Primary objective:      To compare the efficacy of infant LPV/r (40/10mg twice daily if 2-4kg and 80/20mg twice daily     if >4kg) vs. Lamivudine 7,5mg twice daily if 2-4kg, 25mg twice daily if 4-8kg and 50mg twice     daily if >8kg) from day 7 until 4 weeks after cessation of BF (maximum duration of     prophylaxis: 50 weeks for a maximum duration of breastfeeding of 46 weeks) to prevent     postnatal HIV-1 acquisition between 7 days and 50 weeks of age.      Secondary objectives:        -  To assess the safety of long-term infant prophylaxis with LPV/r versus Lamivudine          (including resistance, adverse events and growth) until 50 weeks.        -  HIV-1-free survival until 50 weeks        -  To build clinical trials capacity at the four study sites.      Main endpoint:      Acquisition of HIV-1 (as assessed by HIV-1 DNA PCR) between day 7 and 50 weeks of age      Study population:      HIV-uninfected infants at day 7 (± 2 days) born to HIV-1 infected mothers not eligible for     HAART who choose to breastfeed their infants and who have benefited from the national     prevention of mother to child transmission (PMTCT) program during pregnancy and delivery. The     study will recruit 1500 mother-infant pairs in Burkina Faso, South Africa, Uganda and Zambia.      Study duration:      Infants will be followed up for 50 weeks and the total study duration is five years.      Expected outcome:      This study will inform on the relative advantages (efficacy) and drawbacks of two     interventions to support HIV-1-infected women not eligible for HAART to safely breastfeed     their babies. If found to be safe and efficacious, the regimens would avoid the existing     contradiction between optimal infant feeding and the prevention of MTCT through breast milk.     Clinical trial capacity development will improve the future quality of trials conducted in     these countries.   "
213647|NCT00640276|"     We will identify the influence of long-term treatment of Pitavastatin compared to     non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic     syndrome component score. And we will additionally observe the changes of CVD risk factors     like lipid profile, abdominal fat, insulin resistance and so on.   "
213648|NCT00640289|"     Congenital deficiency of Factor XIII is a rare but potentially life threatening disorder. It     is inherited in an autosomal recessive fashion. Infusion of Factor XIII has proved to be     useful for prevention and treatment of bleeding episodes, especially of spontaneous     intracranial bleedings. In this study, Fibrogammin P will be given to patients with     congenital Factor XIII deficiency and congenital/acquired FXIII deficiency to prevent     bleeding and to treat established bleeding episodes. For Factor XIII prophylaxis to prevent     hemorrhages, the dosage will depend on the weight of the subject. The frequency of Factor     XIII administration will be determined by the factor's circulating half-life. During the     first month only, a Factor XIII pharmacokinetic study will be determined over a 4-week     period. Safety data will include accrual of information on viral safety, liver function,     complete blood counts and adverse events. Historical data concerning spontaneous bleeds will     be collected whenever possible two years prior to treatment with Fibrogammin P.   "
213649|NCT00640302|"     This aim of this project is to evaluate the efficacy of neuraminidase inhibitors in patients     who have a clinical diagnosis of pandemic influenza infection. The study is observational     only. The primary measure used in this study will be mortality. Symptom severity and     duration, treatment limiting side effects, demographic information and resistance will also     be examined. This project will commence upon pandemic influenza being declared in Australia,     Hong Kong or Singapore. Data will be analysed as quickly as possible to help inform the     continued use of neuraminidase inhibitor therapy as a cornerstone of the public health agency     response to pandemic influenza.   "
213650|NCT00640315|"     This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic     effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to     chronic obstructive pulmonary disease (COPD).   "
213651|NCT00640328|"     The trial consists of a dose escalation, to establish the safety of ofatumumab in RRMS     patients. A 48-week treatment period followed by an individualized follow-up period until     normalization of peripheral B-cell counts or Immunoglobulin G (IgG) levels.   "
213652|NCT00640341|"     The objective of this study is to evaluate the performance of the PureVision Contact Lens     compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear     basis.   "
213653|NCT00647959|"     The objective of this study was to investigate the bioequivalence of Mylan's doxycycline     monohydrate 150 mg tablets to Par's Adoxa® 150 mg tablets following a single, oral 150 mg (1     x 150 mg) dose administered under fasting conditions.   "
213654|NCT00647972|"     The objective of this study was to investigate the bioequivalence of Mylan olanzapine 20 mg     tablets to Eli Lilly Zyprexa® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose     administration under fasting conditions.   "
213655|NCT00647985|"     The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180     mg tablets to Aventis' Allegra® 180 mg tablets following a single, oral 180 mg (1 x 180 mg)     dose administered under fed conditions.   "
213656|NCT00647998|"     Numerous neuroprotectants have been effective when given prior to ischemic stroke in animals,     yet they have all have failed when given after ischemic stroke in humans. A novel approach to     ischemic neuroprotection is needed. Many patients who undergo cardiac, vascular, and     neurosurgical procedures develop ischemic central nervous system (CNS) complications. These     high risk surgeries present a unique opportunity to administer neuroprotectant medication     prior to the injury, greatly increasing the likelihood that it will have a positive impact on     outcomes. Patients undergoing descending thoracic aortic (DTA) and thoracoabdominal aortic     (TAA) surgery have a particularly high rate of both brain and spine ischemia. In addition,     these surgeries require placement of a lumbar cerebrospinal fluid (CSF) drain, allowing     access to CSF in order to monitor markers of injury and penetration of medication into the     CNS. We are performing a pilot dose finding trial of prophylactic darbepoetin alfa, a     long-acting erythropoiesis medication with putative neuroprotectant properties, in patients     undergoing DTA and TAA surgery.   "
213657|NCT00648011|"     The objective of this study was to investigate the bioequivalence of Mylan's quinapril HCl     and hydrochlorothiazide 20 mg/25 mg tablets to Parke-Davis' Accuretic™ 20mg/ 25 mg tablets     following a single, oral 20/25 mg (1 x 20/25 mg) dose administration under fed conditions.   "
213658|NCT00648024|"     The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1     mg capsules to Shire US's Agrylin® 1 mg capsules following a single, oral 1 mg (1 x 1 mg)     dose administration under fasting conditions.   "
213678|NCT00648284|"     The primary objective of this study is to assess the total CV risk in patients with type 2     diabetes and also to assess the impact of rosiglitazone in the total CV risk and the     parameters of metabolic syndrome.   "
213664|NCT00648102|"     This research study is for individuals who have advanced breast, colon, pancreatic, ovarian     or bladder cancer. Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine)     to see if it can be used to make the immune system attack the cancer. The study includes     administration of additional treatments, in combination, thought to enhance the immune     response effect. This study specifically administers the vaccine systemically to explore     whether dendritic cell targeted vaccines can generate more robust effects via intravenous     injection. (CDX 1307-02)   "
213665|NCT00648115|"     The purpose of this research is to test the usefulness of a vocational rehabilitation program     for veterans with a history of felonies who also have a mental illness or have substance     dependency.   "
213666|NCT00648128|"     The objective of this study was to investigate the bioequivalence of Genpharm's     clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the     Biaxin® filmtab® (Abbott Laboratories USA) administered under fed conditions. Forty-four (44)     healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized,     in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard,     M.D. at Algorithme Pharma Inc. Montreal, Canada.      Statistical analysis of the data reveals that 90% confidence intervals are within the     acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters     AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets     are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered     under fed conditions.   "
213667|NCT00648141|"     To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac     for the treatment of ankylosing spondylitis   "
213668|NCT00648154|"     The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg     tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose     administered under fed conditions.   "
213669|NCT00648167|"     This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a     treatment for hyperphosphatemia in patients with End-Stage Renal Disease.   "
213670|NCT00648180|"     The objective of this study was to investigate the bioequivalence of Mylan's doxycycline     monohydrate 100 mg tablets to Par's Adoxa® 100 mg tablets following a single, oral 100 mg (1     x 100 mg) dose administered under fed conditions.   "
213671|NCT00648193|"     The objective of this study is to investigate the bioequivalence of Mylan's paroxetine     hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x     40 mg) dose administered under fasting conditions to healthy adult volunteers.   "
213672|NCT00648206|"     This study intends to supply information about the prevalence of psychoactive drugs and     alcohol in suspected DUI samples which are suspected of only one of these rather than both     drugs and alcohol.      Police samples for suspected DUI samples that have been sent for alcohol analysis or drug     analysis only will be screened for drugs and alcohol respectively.   "
213673|NCT00648219|"     The objective of this study was to investigate the bioequivalence of Mylan's olmesartan     medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1     x 40 mg) dose administered under fed conditions.   "
213674|NCT00648232|"     This study will compare the effectiveness of brief versus detailed HIV counseling sessions,     paired with referrals to either HIV-specific medical care or usual care, in reducing HIV risk     behavior and in increasing treatment adherence in Uganda.   "
213675|NCT00648245|"     The symptoms associated with COPD include overproduction of mucus and inflammation in the     lungs. Overproduction of mucus results in impaired lung function and it encourages bacterial     growth and associated COPD exacerbations. Therefore, a treatment that inhibits mucus     overproduction or blocks inflammation could benefit COPD patients. The drug under evaluation     in this study, BIO-11006 Inhalation Solution, is a new drug that may inhibit overproduction     of mucus and may have important anti-inflammatory properties.   "
213676|NCT00648258|"     To evaluate the efficacy, safety, and tolerability of valdecoxib by comparing valdecoxib 10     mg daily (QD) with naproxen 500 mg twice daily (BID) in treating the signs and symptoms of     osteoarthritis (OA) of the knee or hip. The study was designed to collect comparative     information for the local population (Taiwan).   "
213677|NCT00648271|"     The objective of this study was to investigate the bioequivalence of Mylan's metoprolol     tartrate tablets to Novartis' Lopressor® tablets following a single, oral 50 mg (2 x 25 mg     tablets for Mylan's formulation and 1 x 50 mg for Lopressor®) dose administered under fed     conditions.   "
213684|NCT00650403|"     The objective of this study is to investigate the bioequivalence of Mylan's paroxetine     hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x     40 mg) dose administered under fed conditions to healthy adult volunteers.   "
213685|NCT00650416|"     The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12.5     mg tablets to GSK's Coreg® 12.5 mg tablets following a single, oral 12.5 mg (1 x 12.5 mg)     dose administered under fasting conditions.   "
213686|NCT00650429|"     This study was conducted to examine the efficacy and tolerability of ziprasidone     intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the     treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin     American population.   "
213687|NCT00650442|"     The primary objective of this study was to compare the adhesive quality of the current Mylan     estradiol placebo transdermal system, with that of an alternate second generation Mylan     estradiol placebo transdermal system following a single system application. As a secondary     objective, primary dermal irritation was assessed after removal of each transdermal system.   "
213688|NCT00650455|"     The objectives of the study were to evaluate the efficacy, safety, and tolerability of     valdecoxib 10 mg once daily (QD) or naproxen 500 mg twice daily (BID) versus placebo, and to     assess the efficacy of valdecoxib 10 mg QD versus naproxen 500 mg BID, in treating the signs     and symptoms of rheumatoid arthritis (RA) in a severe Rheumatoid Arthritis population.   "
213689|NCT00650468|"     A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy     in Kidney Transplant Patients receiving Prograf and Cellcept   "
213758|NCT00651365|"     This purpose of the study is to determine what dose of JNJ-38877605 is safe and if     JNJ-38877605 has any effect in patients with advanced or refractory solid tumors for which     there are not alternative therapies.   "
213692|NCT00650507|"     This study will be the first large scale randomized study of remote ischemic preconditioning     (RIPC) ever performed and will define the role of this novel therapy as a clinical tool. This     study will also be the first to define preoperative gene expression profiles associated with     poor postoperative outcomes in a control (SHAM) population of children undergoing cardiac     surgery. Finally, the role of RIPC in modifying these gene expression profiles will be     examined. Therefore, mechanistic insight into the proven ability of RIPC to improve markers     of tissue injury, and the expected improvement in clinically relevant endpoints, will be     examined.   "
213693|NCT00650520|"     The objective of this study is to assess the single-dose relative bioavailability of Mylan     Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg     bromocriptine mesylate tablets, following the administration of a 10 mg dose, under fed     conditions.   "
213694|NCT00650533|"     The objective of this study was to investigate the bioequivalence of Mylan's glimepiride 1 mg     tablets to Aventis Amaryl® 1 mg tablets following a single, oral 1 mg (1 x 1 mg) dose     administered under fed conditions.   "
213695|NCT00650546|"     We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28     weeks improves liver histology in diabetic patients with biopsy-proven NASH.   "
213696|NCT00650559|"     There is a growing population of end-stage COPD patients for whom surgical treatments like     lung transplantation and lung volume reduction surgery are not possible. In such patients,     size mismatch between large emphysematous lungs and a restricted chest wall is a major cause     for the reduction of dynamic lung volumes and consequent dyspnea. We hypothesized that     enlargement of the thorax would be a potential alternative strategy to volume reduction     surgery as it may improve lung mechanics by resizing the chest to the lung and does not     further deprive patients from lung tissue which is already scarce.   "
213697|NCT00650572|"     This is a Phase 1 study during which patients with advanced HER2+ solid malignancies or HER2+     metastatic breast cancer will receive investigational study drug ARRY-380.      This study has 2 parts. In the first part, patients with advanced HER2+ solid malignancies,     who have already received at least one previous standard therapy, will receive increasing     doses of study drug in order to achieve the highest dose of study drug possible that will not     cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in     Part 1 (Completed).      In the second part of this study, patients with HER2+ metastatic breast cancer, who have     already received at least one previous standard therapy, will receive the best dose of study     drug determined from the first part of the study and will be followed to see what side     effects and effectiveness the study drug has, if any, in treating the cancer. Approximately     20 patients from the US will be enrolled in Part 2 (Active, not recruiting).   "
213698|NCT00650585|"     The purpose of this study is to replicate a longitudinal evaluation of Project ALERT, a     substance abuse prevention program that targets middle school students.   "
213699|NCT00650598|"     To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading     dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac     sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee     arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered     for 6 (±1) days.   "
213700|NCT00650611|"     The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in     children and teens with psychotic disorders   "
213701|NCT00650624|"     To determine the therapeutic dose range of valdecoxib by comparing the efficacy of three     dosing regimens (5 mg, 10 mg and 20 mg once daily) with placebo for relief of the signs and     symptoms of osteoarthritis of the knee. To assess safety and tolerability of multiple doses     of valdecoxib in patients with osteoarthritis of the knee.   "
213702|NCT00650637|"     The purpose of this study was to determine the efficacy and safety of calcium carbonate for     the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of     calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated     diarrhea.   "
213719|NCT00650858|"     The specific objective of this trial is to determine the lowest dose and dose frequency     possible with the best pharmacokinetic and safety profile and it's ability to remove a blood     clot from the ventricular system.   "
213703|NCT00650650|"     The standard imaging procedure to diagnose a nasal fracture still is radiography (lateral     nasal view and occipitomental view). But technological advances in ultrasonography during the     last few decades have made high-resolution ultrasound devices available to the majority of     medical centers. It has been shown that the bony structures of the nose can be well examined     by ultrasound in the last few years. The hypothesis: Is ultrasound of equal diagnostic     accuracy in diagnosing nasal fractures as radiography is being tested in the investigators'     study. Patients with suspected nasal fracture undergo ultrasound examination in addition to     the routine x-ray imaging. After completion of treatment, the readings of both ultrasound and     radiographs are compared in terms of sensitivity and specificity to diagnose nasal fractures.   "
213704|NCT00650663|"     The purpose of this study is to evaluate whether coadministration of ezetimibe 10 mg/day with     simvastatin 20 mg/day for 12 weeks will result in greater reduction of LDL-C, total     cholesterol (TC), triglycerides (TG), non HDL-C, and apolipoprotein B (ApoB), and greater     increase in HDL-C, compared with simvastatin 20 mg/day as monotherapy for 12 weeks in     African-American subjects with primary hypercholesterolemia. This study is being performed to     better define the efficacy of ezetimibe coadministered with simvastatin in this population.   "
213705|NCT00650676|"     Blind Adults that willing to participate in the study will be tested with well-established     measuring techniques of Balance control using force plate in the movement and Rehabilitation     Laboratory at Ben-Gurion University. An automated algorithm will be used to extract     standardized stabilogram-diffusion parameters from each of the COP data sets collected during     quiet standing. These parameters include diffusion coefficients, critical displacement,     critical time and scaling exponents for both lateral and anterior-posterior sway directions     (Collins & De Luca, 1993). the subjects will be tested in 3 task conditions (eyes     blindfolded, eyes blindfolded holding stick, eyes blindfolded holding a dog). Participants     will be required to stand on the platform 10 times for 30 s For each trial, they will be     instructed to sway as little as possible.   "
213706|NCT00650689|"     The primary objective is to evaluate the efficacy and safety of coadministration of ezetimibe     10 mg with atorvastatin 10 mg in untreated subjects with primary hypercholesterolemia and     coronary heart disease for whom diet and exercise have failed. The primary variable is     LDL-cholesterol (LDL-C), and the secondary variable is total cholesterol (TC), HDL-C, and     triglycerides (TG). The following variables were used to assess the safety and compliance of     the drug: vital signs and laboratory values. Variables were measured before the first     administration of the drug and at the last administration of the drug, after 6 weeks of     treatment. Adverse events were also assessed.   "
213707|NCT00650702|"     The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe     and effective in controlling intraocular pressure in patients with open-angle glaucoma or     ocular hypertension.   "
213708|NCT00650715|"     The purpose of this study was to investigate the acute and chronic effect of whole-body     vibration exercise on serum insulin-like growth factor-1 levels in women with fibromyalgia     (FM). It was hypothesized that women with FM would exhibit an increase in IGF-1 following     both acute and chronic WBV. Twenty-four women with FM were randomized into two groups:     Vibration Group (VG) and Control Group (CG). The VG underwent a protocol with WBV exercise     twice a week for a total of six weeks, whereas the CG performed the same protocol without     vibratory stimulus. Both groups continued with their usual pharmacological treatment. Serum     IGF-1 levels were determined using Enzyme-Linked Immunosorbent Assay (ELISA). To test the     effect of chronic WBV, serum IGF-1 measurements were taken at baseline and at weeks 1,3, and     6 of intervention. To test the effect of acute WBV, within week 1, serum IGF-1 measurements     were taken before and immediately following a session of WBV.   "
213709|NCT00650728|"     As the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left     atrium may damage the esophagus and create esophageal perforations and esophageal left atrial     fistula. The aim of the present study is to compare different methods for visualization of     the esophagus to prevent this complication.   "
213710|NCT00650741|"     The purpose of the study is to investigate the sensitivity and specificity of the Endotect     compared with an ultrasound device in a flow-mediated vasodilatation (FMD) test.   "
213711|NCT00650754|"     The experimental focus of this project is on the interaction of DHEA treatment on pregnancy     in women with otherwise unexplained infertility and evidence of premature ovarian aging     (POA).   "
213712|NCT00650767|"     This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the     effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in     patients on stable doses of methotrexate, and to further evaluate the safety of the study     drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and     Romania will be enrolled in this study.   "
213713|NCT00650780|"     We have just completed a randomized, clinical trial of 100,000 IU Vitamin D3 given as a     single dose at the beginning of winter. We found a wide range of responses to the dose. This     study proposes that genetic differences account for some of the variation in response of     25(OH)D levels after treatment with oral Vitamin D.   "
213714|NCT00650793|"     The purpose of the study was an Open Label Extension to a completed study that evaluated the     efficacy and safety of 3 fixed dosages of Extended Release OROSÂ® Paliperidone   "
213715|NCT00650806|"     The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in     promoting weight loss in patients who are overweight or obese and who do not have diabetes.   "
213716|NCT00650819|"     This is a multicenter, randomized, double blind; active-controlled parallel groups study     enrolling subjects with primary hypercholesterolemia. Subjects receive ezetimibe,     simvastatin, or the combination once daily for 8 weeks to determine the effect on     LDL-cholesterol.   "
213717|NCT00650832|"     The purpose of this study is to determine the antiviral activity, safety and tolerability of     TMC114, formulated as an oral tablet, and administered with a low dose of ritonavir   "
213718|NCT00650845|"     Although there is a well documented risk of acute renal failure with the iodinated contrast     agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity     remains controversial. The aim of this study was to evaluate the safety profile of gadoterate     meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of     patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate     meglumine.   "
213720|NCT00650871|"     A study to investigate the effects of GW679769 on sleep and cognition. Potential subjects     participate in a clinical screening visit and a two-night PSG recording session in the sleep     laboratory. Eligible subjects then participate in three separate two-night PSG sessions in     which they are randomized to receive placebo or one of two doses of GW679769 60 minutes prior     to bedtime, one treatment for each session in a balanced order. Each treatment session is     separated by a two-week drug-free period and occur on the same day of the week. A safety     follow-up visit occurs 2 weeks after the last treatment session.   "
213721|NCT00650884|"     The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is     effective in reducing pain from Plantar Fasciitis (Fasciopathy).   "
213722|NCT00650897|"     Patients with diabetes and major depression treated with Escitalopram might experience     significant improvement in depression and anxiety scores; functional ability;     diabetes-related self-care; and pain symptoms   "
213723|NCT00650910|"     This is a two part study looking at the effect of lapatinib on concentrations of digoxin in     the blood when both drugs are dosed together in Part 1; and looking at the safety and     antitumor effect of lapatinib when used together with possible additional anticancer therapy     as chosen at the doctor's discretion.   "
213724|NCT00650923|"     This phase I trial is studying the side effects and best dose of aflibercept when given     together with radiation therapy and temozolomide in treating patients with newly diagnosed or     recurrent glioblastoma multiforme, gliosarcoma, or other malignant glioma. Aflibercept may     stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses     high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving aflibercept together with radiation therapy and     temozolomide may kill more tumor cells.   "
213726|NCT00650949|"     This study seeks to (i) determine the safe dose of CYT997 when given in combination with     carboplatin in patients with relapsed glioblastoma multiforme (glioma) and (ii) to determine     whether the combination of CYT997 with carboplatin is a useful treatment for glioma.   "
213727|NCT00650962|"     1. Pre-shock cardiopulmonary resuscitation might benefit the survival of out-of-hospital          cardiac patients with ventricular fibrillation / ventricular tachycardia in a post-hoc          analysis of a prehospital trial conducted in Europe (L.Wik,2002). However, it's          effectiveness in the Asian countries, where most firstly recorded rhythm in          out-of-hospital cardiac arrests patients were asystole/pulseless electric activity          rather than ventricular fibrillation / ventricular tachycardia, were not explored yet.        2. This trial was designed to exam if pre-shock cardiopulmonary resuscitation by emergency          medical technicians improves the outcome of all out-of-hospital cardiac arrest patients          in an Asian metropolitan city.   "
213728|NCT00650975|"     1. Assess whether excimer laser coronary atherectomy (ELCA) before direct infarct-related          artery (IRA) stenting results in improved reperfusion success in patients presenting          with acute ST wave elevation myocardial infarction (STEMI) and angiographically evident          thrombus.        2. Validate an ELCA technique for the treatment of STEMI, at high-volume centers          experienced in the treatment of acute myocardial infarction (AMI).   "
213729|NCT00650988|"     This is a single center study to evaluate the efficacy and safety of a new ablation technique     involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper     endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or     intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal     wall, in whom there are no standard treatment options available.   "
213730|NCT00651001|"     A Food Frequency Questionnaire (FFQ), will be provided to 800 adults to assess overall     fructose intake and this will be related to a number of features related to the metabolic     syndrome, including serum leptin, characteristic features of metabolic syndrome (body mass     index, waist circumference, plasma lipids, blood pressure, HOMA index,fasting glucose and     fasting insulin levels) and other as: CRP, fibrinogen, homocysteine and uric acid.   "
213731|NCT00651014|"     The study was designed to assess whether 6 weeks of co-administration of ezetimibe and     simvastatin is more effective than simvastatin monotherapy in allowing patients in the CHD     risk strata of the NCEP III guidelines to achieve their LDL-C target goal of <=3.0 mmol/L. As     this study was to be conducted in Canada, the target LDL-C goal for patients with CHD, or     type II diabetic patients >30 years old with no CHD, was <2.5 mmol/L.   "
213732|NCT00651027|"     The metabolism of PF-00868554 is primarily mediated by CYP3A, and it is anticipated that     hepatic impairment will modify PF-00868554 plasma concentrations. Hence, it is important to     determine the impact of varying degrees of hepatic impairment on the pharmacokinetics, safety     and toleration of 200 mg PF-00868554 administered as a single-dose.   "
213733|NCT00651040|"     Therapeutical trial in patients with idiopathic polymyositis (PM) and dermatomyositis (DM) is     proposed. The study will investigate the safety and efficacy of combined methotrexate (MTX) +     glucocorticoids (GC) treatment compared with GC alone.      This will be a randomised, open-label, assessor-blind, international multicenter trial,     performed in several European centres interested in research on inflammatory myopathies     (IIM).      A total number of 50 patients with PM/DM will be randomised into two groups (1: MTX+ GC and     2: GC only). Patients will be equally distributed between the two groups providing 25     patients per treatment arm. The randomisation will be based on random numbers generated by a     computer program. After being enrolled in the study, the patients will receive 12 months of     therapy followed by a 12-month follow-up period.      The primary endpoint is the total dose of GC ( in mg/kg weight), which will be administered     for 12 months between baseline and the end of treatment.      There are several of secondary objectives, which will be pursued during and after the trial.     Disease activity and damage will be prospectively assessed by tools for myositis disease     activity (MYOACT and MITAX) and for myositis damage (MYODAM and MDI), global assessment of     activity and damage by patients and by physician, muscle endurance, muscle strength by manual     muscle testing, enzyme levels, GC related side effects, functional ability measured by HAQ,     quality of life by SF-36, and number of patients with treatment failures. The other aims will     also include (i) search for reliable prognostic parameters in the further prognosis of     patients with PM/DM and (ii) studies on the pathogenic aspects of IIM. The investigations of     serum, lymphocytes, muscle tissue and MRI will be organized. DNA and RNA will be stored for     future genetic studies.      Patients with definite or probable PM or DM diagnosed according to diagnostic criteria will     be enrolled. They will have disease activity that according to physician's own judgement     requires high dose immunosuppressive treatment (based on clinical assessment of weakness,     elevation of muscle enzymes and, if available, on magnetic resonance imaging findings).     Patients should be previously untreated with the exception of GC treatment up to 8 weeks.      Patients with other than primary idiopathic PM or DM, such as drug-induced myositis, myositis     in association with other connective tissue disease, inclusion body myositis, malignancy     related myositis, and juvenile DM will be excluded.      All patients will start with prednisone 1 mg/kg/day and the dose will be tapered if patients     meet definition of improvement, which has been proposed by IMACS group. MTX will be     administered orally, once weekly, with a starting dose 10 mg. This will be increased     gradually to 25 mg/week if tolerated by week 5. Patients will be first assessed after 2 weeks     and than monthly for a period of 48 weeks. There will be a follow-up after a further 1 year     in order to find out the impact of the early treatment on the long-term disease outcome.      All efficacy analyses will be performed using intention-to-treat population (ITT). In     addition, the primary and secondary variables will be analysed using the per-protocol     population, which will contain all patients in the ITT population, who also reached Week 48     without any major protocol violations. The safety population, which will contain any patient     who received at least one dose of study drug, will be used for all safety analyses.   "
213734|NCT00651053|"     This is a investigator-initiated, single-center, prospective study to evaluate endoscopic     ultrasound (EUS) as a diagnostic test for chronic pancreatitis (CP). EUS detects     abnormalities of the pancreas that may represent scarring from CP. The validation of any new     test requires a comparison with the best available reference standards. There is no true     gold standard for diagnosis of CP; however, pancreatic function testing (PFT) is highly     sensitive for exocrine dysfunction as a surrogate for early fibrosis, and is widely     considered the non-histologic gold standard. There are no well-designed prospective studies     comparing EUS with PFT as reference standard.      EUS detects parenchymal and ductal features of CP said to correlate with fibrosis. We     hypothesize that a predominance of parenchymal fibrosis results in diminished acinar-cell     secretion of enzymes. Conversely, a predominance of ductal fibrosis results in impairment of     ductal secretion of bicarbonate. Because secretin and cholecystokinin (CCK) PFTs measure     unique aspects of pancreatic function (duct-cell and acinar-cell function, respectively), the     use of both hormonal stimulants will allow the most comprehensive investigation of the     significance of EUS features. There are no studies comparing EUS with combined or dual     performance of secretin and CCK PFTs.      The primary objective of this study is to determine the test characteristics of EUS for     diagnosis of CP compared with dual secretin- and CCK- stimulated PFTs as reference standard.     Secondary objectives include to: 1. Determine the optimal number and relative functional     importance of specific EUS criteria, 2. Compare the test characteristics of linear- and     radial-array EUS.      190 patients evaluated for pancreatitis or pancreatic-type abdominal pain will undergo the     new test (radial and linear EUS) and the reference standard (CCK and secretin PFTs). The     EUS examinations will be videotaped and interpreted in a blinded fashion. EUS scores will be     compared with PFT results to allow the calculation of sensitivity and specificity of linear     and radial EUS. Receiver operating characteristics (ROC) analysis will be used to determine     the optimal number of EUS criteria for diagnosis.   "
247072|NCT01078233|"     The main objective of the study is to monitor health outcomes associated with antiretroviral     drugs in a population of HIV-infected patients.   "
213735|NCT00651066|"     The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin     (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an     alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic     induction effect appears to be less important on the associated antiretroviral therapy (ART)     drugs.      This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in     combination with different ART regimens in Vietnamese HIV infected patients with pulmonary     tuberculosis, in order to define optimal doses that will be further tested in a larger phase     III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.   "
213736|NCT00651079|"     To determine safety, tolerability and Pharmacokinetics of GSK1247303   "
213737|NCT00651092|"     The aim of the study is to compare endoscopic submucosal inferior turbinectomy to blunt     turbinectomy in terms of subjective and objective parameters.   "
213738|NCT00651105|"     The purpose of this study is to assess the GLP-1 and non-GLP-1 effects of LAF237 on glucagon     secretion, using treatment observations of the overall glycemic response.   "
213739|NCT00651118|"     The purpose of this study is to determine if two allergy medications (azelastine and     fluticasone) are more effective than placebo or either medication alone (azelastine or     fluticasone)   "
213740|NCT00651131|"     The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients     with superficial and deep post-surgical Gram-positive wound infections   "
213741|NCT00651144|"     The purpose of this study is to obtain data of the coadministration of ezetimibe and     rosuvastatin to support the concomitant use of these two drugs in patients requiring     additional cholesterol-lowering management. Treatment is administered for 14 days.   "
213742|NCT00651157|"     This phase II trial is studying the side effects and how well viral therapy works in treating     patients with metastatic melanoma. Viral therapy may be able to kill tumor cells without     damaging normal cells.   "
213743|NCT00651170|"     Median nerve block is widely practised, avoiding general anaesthesia in a number of cases and     producing excellent post-operative analgesia in orthopedic surgery. Even realised by     experienced anaesthetists,a failure rate of 5-15% is noticed. The principal aim of the study     is to observe the local anesthetic solution diffusion after a conventional median nerve block     technique using neurostimulation. The secondary objective is to compare diffusion and of     block efficacy..   "
213744|NCT00651183|"     The objective of this PMS study is the evaluation of depressive symptoms measured with     Unified Parkinson's Disease Rating Scale (UPDRS) Part I (mentation, behavior and mood) and     with Hospital Anxiety and Depression Scale Depression Subscore (HADS-D) under pramipexole     treatment in early and advanced PD patients. In addition it will be investigated whether     improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part     III). 250 patients diagnosed with Parkinson's disease (PD) will be investigated by 80     specialists (neurologists or neurologists/psychiatrists) across Austria. Pramipexole will be     taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule     independently of food intake) and can be titrated upwards, as required, at weekly intervals     to a maximum total daily dose of 4,5 mg (TID) as per Summary of Product Characteristics     (SPC).   "
213745|NCT00651196|"     An increased skeletal fracture risk in diabetes has only recently been recognized. This human     study is designed to elucidate the effect of Type 1 diabetes on bone remodeling and on     structure.   "
213746|NCT00651209|"     This study will evaluate the use of telbivudine for patients with HBeAg-positive CHB with an     option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve     HBV DNA non-detectability.   "
213747|NCT00651222|"     The purpose of this study is to review cause of death in patients undergoing prostate     brachytherapy at a single institution. Furthermore, we are analyzing patients undergoing     androgen deprivation therapy and whether or not this contributed to cardiovascular deaths,     specifically myocardial infarction.   "
213748|NCT00651235|"     To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive     dilation of aortic root in patients with Marfan syndrome.   "
213749|NCT00651248|"     The purpose of this study is to identify the relation of the salivary flow and the buffer     capacity of the saliva with medicine, buccal discomfort and auto-related illnesses in aged     people.   "
213750|NCT00651261|"     The purpose of this study is to compare the effects, good and/or bad, of a standard     chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined     with or without midostaurin (also known as PKC412), to find out which is better. This     research is being done because it is unknown whether the addition of midostaurin to     chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been     tested in over 400 patients and is being studied in a number of illnesses, including AML,     colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as     FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells     will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells     with the abnormal FLT3 gene.   "
213751|NCT00651274|"     This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing     treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg     alone in further reducing LDL-C concentrations.   "
213752|NCT00651287|"     The purpose of this study is to determine the response rate for the therapeutic goal     (diastolic blood pressure (BP) less than 90 mmHg and systolic BP less than 140 mmHg) at Week     6 for quinapril 20 mg and at Week 12 for quinapril 20 mg, quinapril 40 mg, and quinapril 20     mg plus hydrochlorothiazide 12.5 mg; and to determine the mean decrease in diastolic and     systolic BP measurements and the change in heart rate at Week 6 and Week 12 compared with     baseline.   "
213753|NCT00651300|"     The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal     surgery. Morphine intake is compared between patients on placebo and patients on     parecoxib/valdecoxib.   "
213754|NCT00651313|"     The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective     for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared     to placebo (inactive gel).   "
216015|NCT00679133|"     In this study, MGCD265, a new anticancer drug under investigation, is given daily on a 7 days     on / 7 days off schedule to patients with advanced malignancies to study its safety profile.   "
213755|NCT00651326|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such     as flutamide, bicalutamide, leuprolide, buserelin, and goserelin, may lessen the amount of     androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells.     Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet     known whether giving androgen suppression therapy together with radiation therapy is more     effective with or without docetaxel in treating prostate cancer.      PURPOSE: This randomized phase III trial is studying androgen suppression therapy, radiation     therapy, and docetaxel to see how well they work compared with androgen suppression therapy     and radiation therapy in treating patients with high-risk localized prostate cancer.      CLOSURE: This trial closed to further accrual in November 2009. The study endpoints will not     be reached.   "
213756|NCT00651339|"     Children suffer from Cerebral Palsy that willing to participate in the study will be tested     with well-established measuring techniques of Balance control using force plate before 2     month after BOTOX injection in the movement and Rehabilitation Laboratory at BGU. An     automated algorithm will be used to extract standardized stabilogram-diffusion parameters     from each of the COP data sets collected during quiet standing. These parameters include     diffusion coefficients, critical displacement, critical time and scaling exponents for both     lateral and anterior-posterior sway directions (Collins & De Luca, 1993). Each of the Times     (before 3 month and 6 month after the THA) in two task conditions (eyes closed and eyes close     conditions). Participants will be required to stand on the platform 5 times for 30 s For each     trial, they will be instructed to sway as little as possible. In addition Gait analysis will     be also examined.   "
213757|NCT00651352|"     Open label, single dose, four-way crossover in healthy smokers. Each subject will be treated     with a single dose or four study treatments in a randomized sequence.   "
213759|NCT00651378|"     This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin     10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d     or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal     LDL-cholesterol of <2.5 mmol/L. Treatment phase is 6 weeks.   "
213760|NCT00651391|"     The purpose of this study is to evaluate the effect of ezetimibe coadministered with     simvastatin compared with simvastatin alone when administered for 12 weeks on endothelial     function as assessed by brachial artery reactivity testing (BART) using high-frequency     ultrasound to image the brachial artery vasomotor response to a flow-mediated stimulus     (high-shear stress) in subjects with high cholesterol. The secondary objectives include     evaluation of nitroglycerin-induced vasodilation. In addition, lipid parameters     (low-density-lipoprotein cholesterol [LDL-C], high-density-lipoprotein cholesterol [HDL-C],     triglycerides [TG], total cholesterol [TC]) and C reactive protein (CRP) will be assessed by     treatment group.   "
213761|NCT00651404|"     To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin     10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg     daily in reducing the concentration of LDL-cholesterol (LDL-C) at endpoint after 6 weeks of     treatment.   "
213762|NCT00651417|"     Participants will be diagnosed with localized prostate or breast cancer and be scheduled to     undergo external beam radiation therapy. Participants will either receive a placebo or     organic germanium to be taken 5 times a day starting the day of their first radiation and     continuing through the 1 month follow-up visit. Weekly Quality of life forms will be     completed through the one month follow up visit and then at the 3 month follow up visit. Labs     will be done prior to the start of treatment, at the end of treatment and at the one and     three month follow-up visits.   "
213763|NCT00651430|"     Adults suffer from Osteoarthrosis of hip joint that willing to participate in the study will     be tested with well-established measuring techniques of Balance control using force plate     before 3 month and 6 month after Total Knee Arthroplasty (THA) in the movement and     Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized     stabilogram-diffusion parameters from each of the COP data sets collected during quiet     standing. These parameters include diffusion coefficients, critical displacement, critical     time and scaling exponents for both lateral and anterior-posterior sway directions (Collins &     De Luca, 1993). Each of the Times (before 3 month and 6 month after the THA) in two task     conditions (eyes closed and eyes close conditions). Participants will be required to stand on     the platform 10 times for 30 s For each trial, they will be instructed to sway as little as     possible. In addition step execution test and Late life function and disability     questionnaires will be also examined.   "
213764|NCT00651443|"     The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects     with previously untreated follicular NHL.   "
213765|NCT00651456|"     Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of     MPM will improve overall survival and quality of life beyond that achieved with chemotherapy     alone.   "
213766|NCT00651469|"     The objectives of this study were to evaluate the efficacy and safety of drospirenone 3     mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with     moderate acne vulgaris during 6 treatment cycles.   "
213767|NCT00651482|"     To determine the safety and efficacy of the combination of bevacizumab and everolimus     (RAD001) for the treatment of metastatic renal cell cancer   "
213784|NCT00651703|"     The purpose of this study is to evaluate a specific cellular immune response in melanoma     patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with     different adjuvants.   "
213785|NCT00651716|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors predict whether patients undergoing donor stem cell transplant will develop acute     graft-versus-host disease.      PURPOSE: This clinical trial is studying T cells to see how well they help in predicting     acute graft-versus-host disease in patients undergoing donor stem cell transplant.   "
213786|NCT00651729|"     The purpose of this study is to evaluate the safety of repeated doses of Botulinum Toxin Type     A for the treatment of focal upper limb poststroke spasticity   "
213768|NCT00651495|"     Chronic diseases are the primary cause of morbidity and mortality for older Americans. Active     patient participation in treatment decision-making has the potential to significantly improve     outcomes in chronic disease care, but interventions to increase participation remain     underused. Some studies have found that older individuals are less interested in     participating in clinical decision-making, but other studies find that exposing patients to     decision aids (PtDAs) increases their desire to take an active role in making decisions with     their physicians. The present study targets hard-to-reach seniors by showing decision aids     focused on chronic disease management in senior centers. Decision aids will be made available     in two senior centers through a lending library and by conducting group screenings of the     decision aids followed by moderated discussion of the content with participants. A randomized     encouragement design will be used to test the effectiveness of a modest financial incentive     on increasing seniors' participation in group screenings. The investigators will evaluate the     effects of the intervention on seniors' decision-making role preferences, attitudes,     perceived social norms and self efficacy for asking questions of their physician,     health-related quality of life, physical activity, and changes in prescribed treatment     regimens and self-care.   "
213769|NCT00651508|"     The purpose of this study is to determine the Objective Response Rate of KOS-1584, as a     single agent in patients with stage IIIB/IV NSCLC whose disease has progressed following     initial chemotherapy.   "
213802|NCT00651937|"     The goal of this clinical research study is to learn whether higher doses of stem cells can     help to decrease the symptoms that occur after melphalan. Another goal of the study is to see     how the dose of infused stem cells affects the levels of certain proteins in your blood.     Researchers also want to learn how the dose of stem cells that you receive affects the     quality of your life during the weeks after the transplant procedure.   "
213847|NCT00652522|"     It is the purpose of the study to show the benefit of the endocardial catheter ablation by     pulmonary vein isolation in patients with persistent or longstanding persistent atrial     fibrillation, low LVEF and requiring ICD or CRT-D therapy compared to the best medical     treatment with antiarrhythmic drugs.   "
213770|NCT00651521|"     The prevalence and mortality rate of cardiovascular disease (CVD) in chronic kidney disease     (CKD) patients is high. The prevalence of coronary artery disease (CAD) in CKD population     ranges from 38 to 65%, with an average of 3.3 coronary lesions per person. The relative risk     for death from myocardial infarction and CAD is 1.18 in CKD patients with GFR < 60 ml/min.     Because of this high prevalence of CAD and its high mortality, reducing and preventing CAD     risk factors is crucial in the clinical management of CKD patients.      Low glomerular filtration rate (GFR) constitutes an important independent risk factor for     CAD. Several pathogenic factors play role in the genesis of cardiovascular dysfunction in     chronic kidney disease. Increased traditional CAD risk factor, endothelial dysfunction,     sympathetic hyperactivity, renin-angiotensin system activation, increased glycosylated end     products, all contribute to the characteristic medial calcification of cardiovascular disease     in CKD patients. Hypertension, fluid overloading and anemia further aggravated the cardiac     loading, leading to myocardial hypertrophy with chamber dilatation, heart failure and death.      The mortality rate of CAD in CKD patients is extremely high. The NHANES II (National Health     and Nutritional Evaluation Survey) found an increased of mortality rate> 51%, when the GFR     decreased from > 90 to < 70 ml/min. The 1-year mortality rate in different CKD stage were     0.7% (normal renal function patients), 2.0% (patients with proteinuria), 3.5% (overt     proteinuric patients) and 12.1% (dialysis patients), respectively. However, the clinical     feature and outcome of CAD in different stage of CKD remains unclear.      We conducted a retrospective cohort study involving all patients admitted for coronary     angiography from 1992 to 2004. The patients were categorized into five stages of CAD to     compare the risk factor, clinical feature and outcome. Determination of this relationship can     help to establish factors for early detection of CAD in CKD patients and also prognostic     factor to improve outcome of these patients.   "
213771|NCT00651534|"     This study will examine the effects of formulation on the relative bioavailability of     SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a     single oral dose of each formulation, with five formulations of SB-751689 tested in total.     Blood samples will be taken up to 24 hours postdose after each dose administration. This     study will provide information for future possible formulation development of SB-751689 for     Phase III.   "
213772|NCT00651547|"     The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone     in the treatment of asthma in children aged 6 to 11 years   "
213773|NCT00651560|"     This study is intended to allow physicians to check the superior clinical efficacy of Vytorin     compared to atorvastatin, as the most adequate therapy using the ATP-III goals achievement     and cardiovascular risk reduction in adult patients with dislipidemia.   "
213774|NCT00651573|"     The primary purpose of this study is to determine the best blood level to begin transfusing     red blood cells in individuals undergoing cardiac surgery.      The secondary aim is to determine the impact of red cell transfusion on health-related     quality of life following surgery.   "
213775|NCT00651586|"     This study evaluates the safety and efficacy of gatifloxacin 0.3% ophthalmic solution     compared with ciprofloxacin 0.3% ophthalmic solution in patients with acute bacterial corneal     ulcers   "
213776|NCT00651599|"     Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in     Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and     tolerability of Angeliq.   "
213777|NCT00651612|"     This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or     ocular hypertension patients   "
213778|NCT00651625|"     The study design is a randomized study to directly compare the performance and the outcome of     syringe and needle procedures with a standard syringe or the new reciprocating procedure     device (RDP), which is a type of safety syringe. Over a 5 year period, 820 subjects who     require and assent to a syringe and needle procedure for their usual and customary care will     be randomized to either a conventional syringe or the RPD with one arm with and without     ultrasound guidance. The RPD is designed to be safer, faster, less painful, and more     effective for the patient, and the mechanics of the RPD are intended to provide the physician     with better needle control, resulting in less needle trauma to patient tissues, and thus,     reduced bleeding and pain for the patient. This clinical trial will address whether the RPD     is indeed superior to the conventional syringe for shots, injections, and needle procedures,     and whether it is a safer, less painful syringe.   "
213779|NCT00651638|"     To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as     defined by CYP 2C19 genotype   "
213780|NCT00651651|"     The purpose of this study is to compare Symbicort with its monocomponents budesonide and     formoterol in the treatment of asthma in children and adults   "
213781|NCT00651664|"     This is a multicenter, dose escalation, phase 1 study of MLN8237 in adult patients with     advanced malignancies (excluding those with primary bone marrow involvement, such as     leukemias and multiple myeloma).   "
213782|NCT00651677|"     We hypothesize that hand-assisted laparoscopy will overcome technical difficulties related to     pure laparoscopic rectal surgery and allow surgeons to expand application of laparoscopic     techniques to treating patients with rectal cancer. In this study, we plan to randomly assign     patients diagnosed with rectal cancer to undergo either standard laparoscopic surgery or     hand-assisted laparoscopic surgery. We will then compare both peri-operative and long-term     outcomes of patients.   "
213783|NCT00651690|"     This study evaluates the responsiveness of 7 functional tasks to botulinum toxin Type A     treatment in poststroke patients with spasticity of the upper-limb flexors   "
213788|NCT00651755|"     The goal of this clinical research study is to learn the effect of combining aprepitant with     CHOP or R-CHOP in patients with Non-Hodgkin's Lymphoma (NHL) that is either newly diagnosed     or has come back. Researchers also want to see if aprepitant can help to prevent nausea     and/or vomiting that may be caused by chemotherapy treatment with CHOP or R-CHOP, in these     patients. CHOP consists of four drugs - Cyclophosphamide (also called Cytoxan/Neosar),     Doxorubicin (or Adriamycin), Vincristine (Oncovin) and Prednisolone while R-CHOP includes     Rituximab and CHOP.   "
213789|NCT00651768|"     The purpose of this study is to compare the long term safety of Symbicort with budesonide     alone, in adolescents and adults with asthma.   "
213790|NCT00651781|"     The primary aim of this study is:      • To analyze the efficacy (in order to evaluate the response) of a sequential treatment     scheme of Bortezomib in combination with Fludarabine,Cytarabine and Idarubicin continued with     Bortezomib monotherapy for patients with relapsed or refractory AML ≥18 years old.      The safety aim of this study is:      • To evaluate the safety and tolerance of the sequential treatment scheme proposed with     Bortezomib combined with Fludarabine, Cytarabine and Idarubicin and in monotherapy, measured     on clinical toxicities and laboratory incidences.      The biological aim of this study is:      • To evaluate the Minimal Residual Disease (MRD)impact that will be monitored by     multiparametric flow cytometry carried out at different moments during the treatment.   "
213910|NCT00643721|"     Evaluation of hydration status during exercise and heat exposure.   "
213791|NCT00651794|"     The Neonatal Resuscitation Program (NRP) is the curriculum used to teach providers how to     care for newborns in the delivery room. Breakdowns in teamwork and communication contribute     to NRP quality problems. Adding teamwork instruction to NRP may be a method to improve     communication, teamwork, and the overall quality of neonatal resuscitation. This study uses     simulation to incorporate team training into NRP and to evaluate both the effectiveness and     duration of the team training. Furthermore, because high fidelity simulation is very     expensive and not widely available, we will compare NRP with low fidelity team training to     NRP with high fidelity team training.      Our hypotheses are:        1. NRP with low fidelity team training results in a) better teamwork, and b) better quality          of care compared with standard NRP.        2. NRP with high fidelity team training does not result in better teamwork or better          quality of care than NRP with low fidelity simulation.        3. NRP with high fidelity team training does not produce a longer lasting effect on          teamwork than NRP with low fidelity simulation.   "
213792|NCT00651807|"     This trial is conducted to evaluate the effect of etonogestrel in comparison to placebo on:        -  the prostate volume and the urinary complaints;        -  the urinary flow and the urinary volume in the bladder after voiding;        -  the progression of the disease;        -  the sexual function, well-being and urinary complaints-related Quality of Life. In          addition the safety and the way the drug is absorbed and excreted by the body will be          analyzed.   "
213793|NCT00651820|"     A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6     and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment     versus vehicle alone.   "
213794|NCT00651833|"     The purpose of this study is to determine whether S-1 in combination with Cisplatin is     effective as 1st line therapy in slowing tumor activity in patients with advanced non-small     cell lung cancer. The study is also looking at the safety of S-1.   "
213795|NCT00651846|"     The objective of this study was to investigate the impact of the oral contraceptive YASMIN     (containing: drospirenone 3 mg/ethinyl estradiol 30 mcg) in comparison with the oral     contraceptive MICROGYNON (containing: levonorgestrel 150 mcg/ethinyl estradiol 30mcg) on     factors of blood coagulation and fibrinolysis in female subjects   "
213796|NCT00651859|"     This study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01%     ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic     solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular     hypertension   "
213797|NCT00651872|"     This project has the long-term goal of designing and validating a psychometrically sound     inventory of PTSD-related functional impairment for active duty service members and veterans.     The inventory will include assessments of multiple dimensions of functional impairment and     their impact on quality of life and explicitly show how PTSD symptoms are related to     functional impairment. By creating and validating an inventory to assess PTSD-related     functioning--as they are perceived and reported by active military personnel and veterans--we     hope to offer a useful tool for clinicians, researchers and military leaders. A measure of     PTSD-related functional impairment will have enormous value from a health care perspective in     terms of identifying individuals with the disorder and for promoting more efficient     allocation of resources and efforts towards those who are in most need. We anticipate that     the end product of this study, an efficient, empirically-based measure of PTSD-related     functional impairment will have an immediate impact on the assessment and treatment of     military-related PTSD, in terms of promoting more efficient allocation of resources and     efforts towards those who are in most need. Such a measure will also assist with PTSD-related     compensation and pension procedures and decisions by providing a means to more accurately     assess PTSD-related functional impairment.   "
213798|NCT00651885|"     In chronic CLI patients who are appropriate candidates for endovascular procedures - and many     patients are not because of their advanced age and disease state - the treatment regimen may     include endovascular procedures such as percutaneous transluminal endovascular intervention,     as well as reconstructive surgical procedures such as grafts or bypasses. Amputation is a     last resort where limb salvage cannot be achieved. Despite the success of percutaneous     intervention for small coronary vessels with lumen diameters less than 3 mm, similar     techniques have had limited success in the lower extremity vessels. Infra-popliteal, or below     the knee endovascular intervention, is commonly plagued by subacute thrombotic closure and     restenosis in as many as 50% of treated patients. As a result of the limited success, these     percutaneous procedures have been reserved for the severest cases whereby limb loss is     imminent without intervention. In this context, the sickest of all patients are enrolled in     these trials and poor outcomes are common regardless of the intervention. Agents that promote     intracellular cAMP accumulation, including prostacyclin analogues and phosphodiesterase     inhibitors, suppress smooth muscle proliferation, promote vasodilatation and inhibit platelet     aggregation. These properties suggest that prostacyclin analogues such as treprostinil will     be useful adjuncts to peripheral endovascular intervention and perhaps increase the number of     patients with CLI that can benefit from peripheral endovascular intervention. An orally     available prostacyclin analogue could represent an important treatment advance in the     prevention of restenosis following infrapopliteal angioplasty. In the present study, the     safety and efficacy of oral UT-15C sustained release (SR) tablets will be compared to placebo     in patients with CLI undergoing an infra-popliteal endovascular intervention.   "
216104|NCT00680303|"     The purpose of this study is to evaluate the efficiency of the Lidcombe Program for early     stuttering by varying the time between clinic visits during the first stage of the program.   "
213799|NCT00651898|"     The purpose of this study is to see if the combination of a circulating water mattress     beneath the patient combined with forced air warming over top of the patient will prevent     hypothermia (low body temperature) just as well as a garment that circulates warm water     around the patient, during your major abdominal surgery. Patients will be randomly assigned     to one of these two groups.   "
213800|NCT00651911|"     An open-label study to determine the efficacy and safety of Rasburicase used for the     prevention and treatment of tumor lysis syndrome   "
213801|NCT00651924|"     This study is designed to develop and test the use of Interactive Voice Response (IVR)     technology to deliver pain management treatment. IVR allows individuals to receive and     provide information by using their touchtone telephone. This will allow more people with     chronic pain to receive treatment even if they are not able to drive to an appointment     regularly. In the first part of the study, the investigators will develop new materials like     patient handbooks and pre-recorded explanations about common pain control techniques. In the     second part of the study, a small number of persons with chronic pain will receive treatment     using the new materials. We will ask for their feedback about how well they liked using the     new materials and if the materials are understandable. This will allow us to revise the     materials if we need to prior to studying them with a larger group of people with chronic     pain.   "
213803|NCT00651950|"     The study hypothesis is that nurses and doctors can use a transcutaneously powered ultrasonic     flow sensor to make repeatable and accurate hydrocephalic shunt flow measurements.      The study participants will align the flowmeter probe with a flow sensor hidden under a thick     saline pad that simulates skin. A hidden pump will provide a known flow through the flow     sensor as the participants make their measurements. Each participant will repeat these     measurements over a period of weeks, and the data will tell whether operator skill influences     flow measurement accuracy.   "
213804|NCT00651963|"     Gather additional efficacy and safety (pharmacovigilance) information in the usual daily care     in patients with Dyslipidemia on ezetimibe under real conditions in Colombia associated with     statins.   "
213805|NCT00651976|"     RATIONALE: Hormone therapy using letrozole may fight breast cancer by lowering the amount of     estrogen the body makes. Giving letrozole before surgery allows us to monitor the effects of     letrozole on the tumor on a molecular level and determine markers of response to treatment.      PURPOSE: This study will show us how well letrozole works in treating postmenopausal women     with stage I, II or III breast cancer that can be removed by surgery.   "
213806|NCT00651989|"     Optical coherence tomography (OCT) is a well-established and safe technique that offers the     possibility of visualizing retinal structure and measuring retinal thickness. Time-domain     (TD)OCT is considered the gold standard technique for retinal thickness measurements.     Spectral-domain (SD) OCT has to face the gold standard technique prior to obtain scientific     and clinical consensus.      In our study in healthy subjects foveal thickness will be measured with both TD and SD OCT ,     and the data will be compared to evidence any difference between the two retinal measurements     techniques.   "
213807|NCT00652002|"     The purpose of this study is to compare Symbicort with budesonide alone and with formoterol     alone in the treatment of asthma in adolescents and adults   "
213808|NCT00652015|"     In-Stent-Thrombosis is a rare but serious complication after implantation of stents during     PTCA.   "
213809|NCT00652028|"     The objective of this study is to characterize the pharmacokinetic and pharmacodynamic     profile of dexmedetomidine administered as an intravenous loading dose followed by a     continuous intravenous infusion in pediatric subjects ages ≥2 through <17 years old.   "
213810|NCT00652041|"     Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and     response duration) and security of a sequential scheme of treatment with Bortezomib in     combination with Melfalan and Prednisone (V-MP) (patients > 75 years) or Bortezomib and     Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients <= 75 years) follow     by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients     with refractary or relapse multiple myeloma.   "
213811|NCT00652054|"     The purpose of this study is to determine whether S-1 is effective as 2nd line therapy in     slowing tumor activity in patients with metastatic pancreatic cancer who have previously     received 1st line treatment with a gemcitabine regimen. The study is also looking at the     safety of S-1.   "
213812|NCT00652067|"     This protocol is an single patient IND to provide clofazamine to treat one patient who has     MAI and is resistant to or can not tolerate standard of care. The drug is not otherwise     available.   "
213813|NCT00652080|"     The purpose of this study is to determine the safety and tolerability of pharmaceutical     compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma     and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell     carcinoma by Compound 31510 topical cream.   "
213814|NCT00652093|"     The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone     hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of     pain and reducing the severity of pain associated with walking in patients lumbar spinal     stenosis that have clinical symptoms of neurogenic claudication. Neurogenic claudication is     defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all     of one or both legs provoked with walking and standing and relieved by sitting, squatting, or     forward flexion posturing. The secondary objective is to examine the functional benefit of     oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect to     improvement in duration and distance of walking.   "
213815|NCT00652106|"     This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed     combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol     ophthalmic solutions   "
214671|NCT00653744|"     The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin     with 6 weeks of treatment with Atorvastatin in African American subjects with     hypercholesterolemia.   "
213816|NCT00652119|"     The goal of this clinical research study is to learn about the safety and tolerability of     paclitaxel and carboplatin when given in combination with Avastin to patients with ovarian,     primary peritoneal, or fallopian tube cancer.      Objectives:      Primary study goals:      To investigate the safety and tolerability of carboplatin and paclitaxel administered IP in     combination with IV Avastin To determine if Avastin influences the pharmacokinetics of IP     administered chemotherapeutic agents      Secondary study goals:      To determine the systemic exposure to paclitaxel and carboplatin during initial and late     cycles of IP dosing.      To collect overall survival (OS) and progression-free survival (PFS) To determine changes in     IP VEGF levels To determine site of first recurrence Information on CA-125 response and     clinical response will be descriptive as secondary goals of this study      Exploratory goal:      To estimate proportion of patients completing entire course of treatment   "
213817|NCT00652132|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Chemoprotective drugs, such as sodium thiosulfate, may protect normal cells from the side     effects of chemotherapy. It is not yet known whether giving sodium thiosulfate is effective     in reducing hearing damage caused by cisplatin in treating young patients with liver cancer.      PURPOSE: This randomized phase III trial is studying how well sodium thiosulfate works to     decrease hearing loss caused by cisplatin in treating young patients with stage I, stage II,     or stage III childhood liver cancer.   "
214129|NCT00655187|"     This study aims to evaluate the effectiveness of Rotarix™ vaccine in the general population     in Singapore by monitoring the overall reduction in RV SGE and also by assessing the direct     protection offered by the vaccine in hospitalised infants through a case-control study.   "
213818|NCT00652145|"     The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin     (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of     relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels     <50µg/g stool will be observed for 48 weeks. All patients will have FCP concentration     measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All     patients with persistently elevated FCP will receive one or both of the following     interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of     Lialda. Reduction in FCP levels below 50µg/g stool 6 weeks after randomization will be the     primary outcome. The proportion of patients achieving this outcome will be compared between     groups using Fisher's exact test. All randomized patients as well as those who were excluded     from the randomized trial because of a low FCP concentration at baseline will be followed to     week 48 to determine the rate of clinical relapse.   "
213819|NCT00652158|"     This is a phase 1 clinical trial designed to evaluate increasing durations of MLN8054 oral     dosing in patients with advanced malignancies. MLN8054 will be given once daily for 4 to 7     consecutive days per week for 2 to 3 weeks. Following the 2- to 3-week treatment period there     will be a 2 week recovery period.   "
213820|NCT00652171|"     This study reports a clinical trial evaluating lamotrigine safety and efficacy as an     antidepressant augmentation agent in treatment resistant depression, therefore adding more     empirical evidence to the limited number of studies on the use of lamotrigine.   "
213821|NCT00652184|"     A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01     (sorivudine) cream 3%.   "
213822|NCT00652197|"     The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in     hydrocephalic shunts.      The ultrasonic sensor will measure cerebro-spinal fluid drainage in hydrocephalus patients     with external ventriculostomies and extra-ventricular drainage systems. The sensor     measurements will be compared with the volume of fluid collected by the drainage bag.      After a 24-hour measurement period, the doctor will change the drainage bag position to     simulate the patient sitting up and leaning back, to see if this temporarily stops flow     through the drainage line.      This data will show whether the sensor accurately measures typical drainage flows seen in     hydrocephalus patients. This research will help develop an implantable flow monitor for     pediatric hydrocephalus patients.   "
213823|NCT00652210|"     Multiphoton microscopy (MPM) has been shown to be able to image tissue at a cellular level.     Our project will initially evaluated the ability of MPM imaging to distinguish normal bladder     urothelium from atypical and malignant urothelium in the ex vivo setting. After development     of sufficient criteria, we plan to develop an endoscopic bladder probe that will provide a     non-invasive means to image the interior of the bladder at the cellular level, which would     provide direct evidence of the presence of tumor without a biopsy. After exhibiting     usefulness of MPM imaging for bladder cancer, we will look at other organs beginning with the     colon.   "
213824|NCT00652223|"     The purpose of the study is to test the safety, tolerability, immunogenicity and clinical     efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and     asthma due to house dust mite allergy in a single-center, open-label setting.   "
213825|NCT00652236|"     The purpose of the study was to determine the cost-effectiveness of a function-centred     treatment (FCT) compared with a pain-centred treatment (PCT) in patients with chronic low     back pain (LBP) in an in-patient setting. Follow-up lasted three years. Direct and indirect     costs were recorded by questionnaires sent to health insurances, employers and Swiss     Disability Insurance Company.   "
213826|NCT00652249|"     The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a     malfunctioning shunt valve.      The study will simulate an implanted shunt flow monitoring system by placing the flow sensor     and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will     be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting     up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's     pressure release settings for each cycle of raising/lowering the bag.      By monitoring shunt flow during these changes, the doctors hope to develop new ways to     diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.   "
213827|NCT00652262|"     BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with     spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be     improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not     sufficiently effective   "
213843|NCT00652470|"     The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH)     have a better long-term outcome at 5 years when they are treated with a new procedure,     endoscopic third ventriculostomy (ETV), than infants treated with the more traditional     treatment, insertion of a cerebrospinal fluid (CSF) shunt.   "
213828|NCT00652275|"     This study will be the fourth time that the candidate malaria vaccine Merozoite Surface     Protein - long synthetic chain, will be tested in malaria endemic populations.in the     past,once tested in adults and twice in children proved to be safe in all three occasions for     this phase IIb study in children to proceed. This study will include children who will be     randomly allocated to either receive the malaria vaccine adjuvanted with Aluminium Hydroxide     or the Verorab control. Each participant will receive 3 immunizations, without the clinical     investigators or the participants themselves knowing what has been given. They will then be     followed-up for immediate reactions to vaccination, extended safety profile and immunological     response associated with protection from malaria. These children will be followed up for over     a longer term of two years. Blood will be taken to evaluate the biological safety parameters     and also the immune responses.   "
213829|NCT00652288|"     The aim of this study is to evaluate the variations in pharmacokinetic and pharmacodynamic     properties of rapid-acting insulin analogs when given as a bolus by subcutaneous insulin     infusion pump as typically encountered in the care of children with type 1 diabetes.      The specific factors under investigation are:        -  the effects of puberty        -  type of insulin analog        -  site of catheter insertion        -  and age of catheter   "
213830|NCT00652301|"     To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and     simvastatin given alone on intestinal cholesterol absorption.   "
213831|NCT00652314|"     This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial     to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat.      Within this clinical evaluation, Thrombi-Gel will be compared to the current standard of     care, a gelatin sponge (Gelfoam) plus Thrombin JMI, by using a 2:1 randomization ratio.     Subjects will be randomized to one of two (2) treatment groups. One (1) group will be treated     with Thrombi-Gel, while one (1) group will be treated with the gelatin sponge plus thrombin.     All study data will be analyzed according to the subjects' assigned randomization group     assignment, regardless of the treatment actually delivered.   "
213832|NCT00652327|"     This is a randomized, open label, parallel group comparison study. Following a 1-week     screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to     ongoing statin treatment (ezetimibe plus simvastatin, atorvastatin or pravastatin at doses of     10/20, 10/10 or 10/20 mg), or doubling the dose of ongoing statin (simvastatin 40 mg,     atorvastatin 20 mg, or pravastatin 40 mg). Study drug will be administered once daily in the     evening for 8 weeks. Patients will be instructed to follow a National Cholesterol Education     Program (NCEP) or similar cholesterol-lowering dietary regimen throughout the study.   "
213833|NCT00652340|"     This study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and     erlotinib as measured by time to disease progression to test the hypothesis that down     regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor     will have a clinical benefit compared with erlotinib alone.   "
213834|NCT00652353|"     The purpose of this study is to evaluate wether the use of a mnemonic strategy could improve     the recall of the Ottawa Ankle and foot Rules' guidelines among medical students and     residents   "
213835|NCT00652366|"     This study will compare the efficacy and safety of escalating versus standard doses to rash     of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer.     During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus     gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not     developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1     will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2     weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other     dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients     will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle.     The anticipated time on study treatment is until disease progression, and the target sample     size is 100-500 individuals.   "
213836|NCT00652379|"     The purpose of this study is to investigate if co-treatment of acromegalic patients, who     beforehand are considered well-controlled on SA monotherapy, with pegvisomant and SA will     improve insulin sensitivity and glucose tolerance, and if these effects of co-treatment can     be obtained at a neutral cost as compared to SA mono therapy.      Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and     intramyocellular fat.   "
213837|NCT00652392|"     The purpose of this study is to compare a dose of Symbicort taken once daily with other     dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in     adolescents and adults   "
213838|NCT00652405|"     Moderate alcohol consumption has consistently been associated with lowered risk of developing     type two diabetes mellitus compared to abstainers and heavy drinkers. However, the underlying     mechanism for the lower risk of type two diabetes is not clear.      Hypothesis: moderate alcohol consumption for four weeks changes gene expression pathways of     inflammatory status, insulin sensitivity and lipid and carbohydrate metabolism in adipose     tissue in both lean and obese postmenopausal women.      Hypothesis: Oral sensory stimulation by means of alcohol in the oral cavity will induce a     cephalic phase reflex as indicated by increased autonomic & endocrine responses in     postmenopausal women.   "
213839|NCT00652418|"     The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of     0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three     regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179     not assessable: caused by contrast media in the evaluation of structural abnormalities.     Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with     arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also     assessed.   "
213840|NCT00652431|"     This is a single-center, randomized, open-label, 3-period, 3-treatment multiple-dose     crossover study designed to assess the interaction between VYTORIN® (Ezetimibe and     Simvastatin) and NIASPAN® (Niacin Extended-Release Tablets) in healthy subjects. Treatment     spans 7 days   "
213841|NCT00652444|"     The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.   "
213842|NCT00652457|"     To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in     patients with Huntington's disease (HD).   "
213845|NCT00652496|"     This study evaluates the safety and efficacy of different formulations of bimatoprost     ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or     ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03%     given to the fellow eye of each patient   "
213846|NCT00652509|"     Behavior change and self-efficacy are key for patients with diabetes to sustain blood sugar     goals, but most care systems do not provide effective support to assist patients in     successful ongoing self-management. After initial education, many programs are limited by     allowable Medicare reimbursement for diabetes education which currently requires physician     referral and cannot exceed two hours of training per year for a beneficiary, plus one hour of     nutritional services. These services are usually provided either on an individual basis or     occasionally through a traditional group class approach. For patients with established type 2     diabetes who are not achieving optimal glycemic control, we propose to develop and formally     evaluate in a randomized trial a novel group experience to educate and motivate patients with     established type 2 called IDEA, (Interactive Dialogue to Educate and Activate). This     multi-site, randomized, prospective trial will randomize 621 patients with inadequately blood     sugar control levels to one of 3 study groups: (1) IDEA - patients receive group sessions     totaling 8 hours, with an average of 10 patients per group, using conversation maps as a     conduit to facilitate dialogue between providers and patients (2) Individual Education (IE) -     patients receive 2 hours with a nurse educator and 1 hour with a dietitian, and (3) Usual     care (UC)- patients receive no research intervention. The primary analyses will involve mixed     model regression to assess whether IDEA improves outcomes compared to IE and UC. Blood sugar     level, blood pressure, and lipids will be evaluated 6 and12 months post-randomization and     behavioral, emotional, and satisfaction outcomes through survey at baseline, 3, 6, 9 and 12     months. Depending on 12 month results, a longitudinal four year post intervention analysis is     planned to assess sustainability of treatment effects and cost-effectiveness.   "
213848|NCT00652548|"     This studies investigates the hypothesis that bedside ultrasound is as accurate as plain     x-rays for diagnosing clavicle fractures in children in a pediatric emergency department.     Children with shoulder injuries are enrolled and receive both an ultrasound imaging     (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or     better)accuracy, with less cost, time, and radiation.   "
213849|NCT00652561|"     The purpose of this study is to determine whether S-1 is effective as 2nd line therapy in     slowing tumor activity in patients with advanced non-small cell lung cancer. The study is     also looking at the safety of S-1.   "
213850|NCT00652574|"     The goal of this clinical research study is to learn how dasatinib affects biomarker levels     in patients with malignant pleural mesothelioma that may be able to be removed by surgery.     The safety and effectiveness of this drug will also be studied.      This research study is financially supported by the United States Department of Defense.   "
213851|NCT00652587|"     The purpose of this study is to evaluate whether hepatectomy combining with adjuvant     transcatheter arterial chemoembolization (TACE) for Stage IIIA hepatocellular carcinoma (HCC)     resulting better long-term survival outcome when compared with hepatectomy alone.   "
213852|NCT00652600|"     To compare the single-dose bioavailability of Propranolol 160 Mg ER Capsules with Inderal-La   "
213853|NCT00652613|"     Head & Neck squamous cell carcinomas are the commonest cancers afflicting the developing     countries. Traditionally surgery or radiotherapy alone in the early stages and surgery with     postoperative radiotherapy in advanced stages have been the mainstay of treatment. Of late     there has been a paradigm shift in the management of these cancers, particularly those of the     oropharynx and laryngopharynx, where chemoradiation has been advocated as part of organ     preservation protocol with good outcomes. Conventional radiotherapy involves the use of 2 or     3 field technique with or without compensators to encompass the volume at risk to radical     doses of 66-70 Gy typically needed to sterilize gross disease. This strategy however is     associated with considerable acute morbidity (mucositis, dysphagia, dermatitis) and     debilitating late toxicity (xerostomia). Three dimensional conformal radiation therapy     (3D-CRT) and intensity modulated radiation therapy (IMRT) have the potential to improve the     dose distribution, with increased doses to the target volumes and reduced doses to     surrounding normal structures, thereby improving the therapeutic ratio.   "
213854|NCT00652626|"     The purpose of this study is to evaluate three things. The first being whether azacitidine is     absorbed in the body at the same rate or proportion for different concentrations. The second     is to determine the effect renal impairment has or does not have on the absorption of     azacitidine. The third is to determine if azacitidine is safe and well tolerated in patients     with renal function impairment.   "
213855|NCT00652639|"     To compare the single-dose bioavailability of Clonazepam tablets 1 mg and Klonopin tablets 1     mg   "
213856|NCT00652652|"     This is a randomized, open-label, three-way crossover design study with 3 treatment     groups:TREATMENT A: Furosemide;TREATMENT B: Nesiritide administered IV bolus, followed by an     infusion for 6 hours;TREATMENT C: Treatment B for at least 15 minutes, then administration of     treatment AAll sequences involving both furosemide and nesiritide had the nesiritide infusion     started first, at least 15 minutes before furosemide was administered. Each treatment will be     administered according to 1 of 6 sequences to which patients are randomized. Patients will     remain in the Clinical Research Unit for 7 days, with treatments administered on Days 2, 4,     and 6, with equilibrium (rest) days on Days 1, 3, and 5. All patients will be followed for     safety throughout the treatment phase, and by telephone between 7 and 14 days after they are     discharged from the Clinical Research Unit.   "
213857|NCT00652665|"     To compare the single-dose Bioavailability of Kali and Aventis   "
213858|NCT00652678|"     Some patients who undergo breast cancer treatment with lumpectomy followed by radiation     therapy develop significant late skin and soft tissue changes, resulting in a poor cosmetic     outcome. The goal of this study is to try to predict severe tissue reactions by using a     combination of three of the latest blood tests, one of which we have developed ourselves.   "
214017|NCT00645125|"     To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin     oral antibiotic suspension medications in pediatric subjects. It is designed to determine if     Omnicef or amoxicillin is preferred to the other with regard to taste or smell.   "
214018|NCT00645138|"     The purpose of this project is to determine if there is a difference between paravertebral     block and general anesthesia in terms of time to discharge from the Post-Anesthesia Care Unit     and pain level in patients undergoing outpatient breast cancer surgery.   "
213859|NCT00652691|"     RATIONALE: Giving colony-stimulating factors, such as G-CSF help stem cells move from the     patient's bone marrow to the blood so they can be collected and stored. Combination     chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem     cells are returned to the patient to replace the blood-forming cells that were destroyed by     the chemotherapy.      PURPOSE: This randomized trial is studying the side effects and best dose of topotecan when     given together with high-dose cyclophosphamide, and carboplatin followed by an autologous     peripheral blood stem cell transplant in treating patients with recurrent ovarian cancer or     primary peritoneal cancer.   "
213860|NCT00652704|"     To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent     to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)   "
213861|NCT00652717|"     Collecting local data, safety and experience trial.   "
213862|NCT00652730|"     To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl     Tablets   "
213863|NCT00652743|"     Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus     found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is     imminent and could be severe. Prevention and control will depend on the rapid production and     worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must     be developed and tested in clinical trials to determine the best formulation and vaccination     schedule.      The purpose of this study is to assess the immune response of a candidate pandemic vaccine.     The protocol posting deals with objectives & outcome measures of the secondary phase of this     study. The objectives and outcome measures of the primary phase are presented in a separate     protocol posting (NCT number = 00449670).   "
213864|NCT00652756|"     The purpose of this study is to evaluate the use of the VersaMed iVent ventilator in the     acute care setting, hypothesizing that, in comparison to the standard approach, the use of     the VersaMed will facilitate transport and reduce transport-associated complications while     providing equivalent ventilatory support and transport success rates for both intubated     patients and patients receiving noninvasive ventilation.   "
213865|NCT00652769|"     In the UK, staging of lung cancer is time consuming (taking on average more than 3 weeks),     costly and inaccurate in up to 20% of cases. The investigators wish to determine whether     using the newer techniques of endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS)     improves lung cancer staging. The investigators' hypothesis is that EUS (endoscopic     ultrasound) or EBUS (endobronchial ultrasound guided transbronchial needle aspirate) as a     first test after CT scan in the diagnosis and staging of lung cancer will result in a     reduction in the time from first outpatient appointment to treatment decision, a reduction in     the total number of scans and investigative operations, fewer outpatient attendances and a     reduction in healthcare costs.   "
213866|NCT00652782|"     A study to determine the most appropriate dose of MK7418 in heart failure patients presenting     with symptoms of volume overload requiring increased diuretic doses.   "
213867|NCT00652795|"     To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline     capsule (Monodox)(Oclassen).   "
213868|NCT00652808|"     This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was     at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal     anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic     osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and     tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA     of the knee.   "
213869|NCT00643188|"     Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. The     incidence and prevalence of AF increase exponentially with increasing age and AF is     associated with higher mortality, more frequent hospitalization, and lower quality of life.     Furthermore, AF is often associated with heart failure. The majority of AF is initiated by     ectopic foci found primarily in the pulmonary veins. It was shown that catheter ablation of     those veins could eliminate episodes of AF. In patients with heart failure, catheter ablation     could improve cardiac function, symptoms and quality of life. It remains still unknown     whether AF ablation is more effective than conventional treatment in terms of mortality and     morbidity.   "
213870|NCT00643201|"     The purpose of this study is to evaluate the effects of an investigational blood thinner,     apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep     vein thrombosis (DVT) or pulmonary embolism (PE)   "
213871|NCT00643214|"     To determine if Tetrix Cream,, when applied to the skin lesions on patients with contact     dermatitis, slows or interferes with the healing of the lesions.   "
213872|NCT00643227|"     The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained     release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g     by mouth once daily, when used to treat adults with mild to moderate community acquired     pneumonia (CAP), and that both treatments were safe.   "
213873|NCT00643240|"     RATIONALE: Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing     substances to them without harming normal cells. This may be effective treatment for     leukemia.      PURPOSE: This phase I trial is studying the best dose of yttrium Y 90-labeled monoclonal     antibody BU-12 in treating patients with advanced relapsed or refractory acute lymphoblastic     leukemia or chronic lymphocytic leukemia.   "
213874|NCT00643253|"     We will conduct a randomized, controlled trial of routine, pre-natal care practice-site based     pre- and post-natal breastfeeding promotion interventions in low-income minority women, with     stratification for maternal country of origin. Our primary outcome measure is breastfeeding     duration and extent, i.e. intensity. Our secondary outcomes measures are: a) infant weight,     and b) participant/ provider experiences of the intervention.      The Provider Approaches to Improved Rates of Infant Nutrition & Growth Study (PAIRINGS) trial     randomizes women to a Prenatal Care Provider (PNC) + Lactation Consultant (LC) intervention,     or Control group. The PNCs will use a brief, computer prompted protocol throughout pregnancy     and at follow-up of maternal-infant dyads. The LC will meet women, one-on-one while pregnant,     at daily hospital rounds, during well-infant care and (as needed) home visits. Post-partum     interviews at 1,3 and 6 months will collect infant feeding data.      Primary Outcomes (Hypotheses): Breastfeeding        1. Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences, by          treatment group, in BF intensity. Intensity will be assessed via 7 day recall of the          frequency of breastmilk feedings vs. other liquids and solids.        2. Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences, by          treatment group, in the rate of exclusive BF.           Secondary Outcomes (Hypotheses): Infant Growth        3. Weight-for-Length, by Breastfeeding Intensity: There will be a significant association          between BF intensity and weight-for-length z scores at 4,6,9, and 12 month well-child          visits.        4. Weight Gain, by Breastfeeding Intensity: There will be a significant association between          BF intensity and weight gain from the 4th -12th month of age.        5. Weight-for-Length, by Treatment Group: There will be a significant association between          treatment group and weight-for-length z scores at 4,6,9, and 12 month well-child visits        6. Weight Gain, by Treatment Group: There will be a significant association between          treatment group and weight gain from the 4th - 12th month of age.   "
213875|NCT00643266|"     We have developed a training intervention that successfully improves older adults' memory. We     have also shown that older adults whose memory is as good as younger adults' memory (Hi-Old)     use an altered pattern of memory-related brain activity compared to younger adults, whereas     healthy older adults with poorer memory (Lo-Old) do not. We have also shown that individuals     with amnestic Mild Cognitive Impairment (aMCI) have impairments of conscious, effortful,     Recollection-based memory processes, whereas their automatic, Familiarity-based memory     processes are intact. Our primary current goal is to investigate whether our successful     memory intervention will improve Recollection and produce induce altered patterns of brain     activity in the Lo-Old and aMCI.      Young, Lo-Old, Hi-Old, and aMCI will be scanned using functional magnetic resonance imaging     while performing two memory tasks. Half of the Lo-Old and half of the aMCI will then receive     the memory intervention, while the other half in each group will receive a control program     consisting of information and games about aging. The Lo-Old and aMCI will then be rescanned     while performing the two memory tasks. We predict that the memory intervention will improve     performance on a number of memory tasks, and will induce altered patterns of brain activity.     In the Lo-Old, their brain activity after the memory intervention will look more like the     Hi-Old, while brain activity will become more focal in the aMCI.   "
213876|NCT00643279|"     The purpose of this clinical research study is to evaluate the safety of an investigational     implantable hemodynamic monitor (IHM). The IHM is implanted surgically under the skin in the     upper chest area and records the force with which the heart pumps blood (heart pressures).     This study will also determine how doctors use the information related to heart pressures in     the management of heart failure.   "
213877|NCT00643292|"     A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy,     safety, and compliance of a single dose of azithromycin extended release compared with a     10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent     or recurrent ear infections   "
213878|NCT00643305|"     The purpose of this study is to determine whether motivational interviewing and skills     building interventions reduce HIV risk behavior for adults with serious and persistent mental     illness.   "
213879|NCT00643318|"     The purpose of this study is to assess the short and long-term outcomes after CyberKnife     stereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients who     are medically inoperable.   "
213880|NCT00643331|"     This clinical trial aims to evaluate the effects of a 12 month gym- and home-based exercise     program on bone density and falls risk factors in postmenopausal women with low bone density.     It is hypothesised that the exercise program will lead to improvements in bone density and     falls risk factors such as balance and muscle strength compared with usual care.   "
213881|NCT00643344|"     The purpose of this study is to determine whether an innovative program that combines     mindfulness-based stress reduction and mindful eating practices with diet and exercise     guidelines (CALMM+ intervention) will lead to greater weight loss and more favorable body fat     distribution than a conventional weight-loss program(Diet-Ex intervention).   "
213882|NCT00643357|"     The purpose of this study is to assess the efficacy and the safety of Kalinox® 170 bar, over     a period of three consecutive care procedures in burned children. It's a international     (Spain, France, Tunisia and Belgium) study with 8 investigator centers.   "
213883|NCT00643370|"     Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation     treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In     some situations, tumors move enough during breathing so that some or all of the tumor may be     missed by a radiation treatment. One way to decrease the amount a lung tumor moves during     radiotherapy treatments is for patients to held their breath briefly during a radiation     treatment. By doing this, a patient's lung tumor may not move as much as it would during     regular breathing. In this study, the investigators aim to study patients with lung cancers     which move during breathing. Patients will be asked to hold their breath after inspiration     while a CT scan of their lung tumor is obtained. The purpose of this study is to study how     much less patients' lung tumors move when they hold their breath   "
213884|NCT00643383|"     A multi-center placebo controlled, double-blind, trial comparing the analgesic efficacy and     safety of Acetram Contramid® BID versus placebo for the treatment of acute low back pain in     patients between 18 and 80 yrs of age.   "
213885|NCT00643396|"     The majority of patients with small cell lung cancer have incurable extensive stage disease.     The usual initial treatment for this condition is chemotherapy which produces responses in     about 50-80% of patients. Despite this, the cancer usually returns. Once common body region     where it re-grows is in the chest, which can cause symptoms such as shortness of breath,     cough, difficulty swallowing, pain and bleeding. These symptoms can worsen a patient's     quality of life and in some situation be life-threatening. In this study , we propose to give     patients who have extensive stage small cell lung cancer which responds to chemotherapy     radiotherapy treatments to the chest. By giving this type of radiation before the cancer has     a chance to re-grow, we hope to control the disease within the chest and prevent future     symptoms that it may cause if the cancer were to re-grow in the chest. Patients treated on     the protocol will be checked regularly for disease control, quality of life and radiation     side effects, if any.   "
213886|NCT00643409|"     The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin     sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once     a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to     evaluate the safety of both treatments.   "
213887|NCT00643422|"     In this study the reproducibility of optical coherence tomography measurements should be     evaluated.   "
213888|NCT00643435|"     Patient self-efficacy, or confidence in one's ability to take the necessary steps to achieve     a goal, has been shown to influence a number of important health behaviors and outcomes.     However, current ways of increasing patient self-efficacy are time and labor intensive and     occur away from doctor visits, where most health care is delivered. We developed, and are     testing in a study the effectiveness of a new way of teaching doctors how to talk to patients     during office visits in a way that will boost their patients' self-efficacy for changing     important health behaviors.   "
213889|NCT00643448|"     Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at     initiation of treatment and at steady state   "
213891|NCT00643474|"     This randomized, parallel study compares 2 groups of type 2 non-insulin treated (NIT)     diabetes patients using the Accu-Chek Aviva glucometers. One group (Intensive Group) will     perform a 4-point daily glucose monitoring profile 3 times a week Monnier-based. These     patients will also receive specific glycemic targets and suggestions on how to reach them     following lifestyle recommendations. At the same time, investigators will use SMBG results,     downloaded from glucometers, to improve patients' therapy. The second group (Control Group),     will follow the SMBG standard care usually adopted in their centers. To be eligible, patients     do not to have performed a previous intensive SMBG management (the execution of SMBG     measurements used to modify lifestyle, diet or physical activity, in a systematic/structured     manner and/or to manage therapeutic approach). The anticipated duration of the trial is 12     months, and the target sample size is 1000 individuals.   "
213892|NCT00643487|"     Anterior knee pain has been an enigmatic problem for orthopedic surgeons. Recent studies, as     well as the clinical observation of the principle investigator have suggested that     arthroscopic resection of the infrapatellar plica (IPP), a vestigial remnant from embryonic     development of no known clinical or biological significance, may eliminate this pain. The     mechanism whereby this pain is related to the IPP is unclear. This study will document the     mechanical behavior of the IPP as recorded on video among a group of subjects who are     undergoing arthroscopy. Radiographic verification of the observed behavior will be obtained     by injection of contrast material, and then fluoroscopic recording of a standard series of     motions. The plica will be resected to avoid any possibility of residual symptoms related to     its presence, a further fluoroscopy of the knee without plical attachment, and the procedure     terminated.   "
213893|NCT00643500|"     Patients with partial-onset seizures seen in community-based practices were to be included in     this therapeutic use study        -  to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the          favorable safety of the drug found during clinical development        -  to obtain further information about optimal dosing in daily clinical practice. Compared          to previous registration trials, the study population corresponded more closely to that          seen in daily clinical practice.   "
213894|NCT00643513|"     To study QoL related response, symptom spectrum and severity in disseminated breast cancer     patients receiving Faslodex hormonal therapy.   "
213895|NCT00643526|"     The main purpose of this study is to evaluate how well the autoinjector works in a group of     people who are likely to use the autoinjector for injecting their medicine in the future.     However, no active medicine is given by the autoinjector.   "
213896|NCT00643539|"     The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin     pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin     pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15     years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were     assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.   "
213897|NCT00643552|"     This project will evaluate muscle strength and its relationship to everyday function in     individuals with Down Syndrome.   "
213898|NCT00643565|"     This open-label two-arm study will assess the safety and efficacy of a combination of     bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in     childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma     soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard     chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of     induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1     of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy     with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time     on study treatment is 1-2 years.   "
213899|NCT00643578|"     The purpose of this study is to find out whether a difference between two doses of formoterol     can be detected by methacholine challenge.   "
213900|NCT00643591|"     The objectives of the trial are:        -  To determine the localisation within the primary tumor of the therapy resistant cells,          before and during radiotherapy to determine a possible accurate boost volume.        -  To determine changes during treatment intra- and extratumoral within the irradiated          area.(Intratumoral: change of up-take - decrease, increase, change of localization/          Extratumoral: effects of temporal changes in up-take - e.g. due to oedema).   "
213901|NCT00643604|"     The purpose of this 8-week study is to compare the effects of switching from therapy with     epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing     to Remodulin will have on patient satisfaction with their treatment and impact on quality of     life.   "
213902|NCT00643617|"     The purpose of this study is to investigate the effects of CyberKnife radiosurgery in     patients with early stage organ-confined prostate cancer and to evaluate the effects of this     treatment on the quality of life over time.   "
213903|NCT00643630|"     To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury     to the skin   "
213904|NCT00643643|"     To investigate the relationship between the pharmacokinetics and pharmacodynamics of     UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).   "
213905|NCT00643656|"     A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the     realization of liver biopsy in order to relax him and to reduce his pain during this painful     medical treatment. This single investigator centre and national clinical trial is done     blindly : half of patients will receive 50% nitrous oxide / 50% oxygen premix and half of     them a placebo gas (mixture of 50% oxygen and 50% nitrogen). 94 patients will be included in     this clinical protocol.   "
213906|NCT00643669|"     The objective of this study was to describe the intraocular pressure-lowering efficacy of     AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated     control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP     was measured every 4 hours, beginning at 8 AM for 24 hours.   "
213907|NCT00643682|"     The purpose of this study is to determine whether adding a simple educational card to     standard pre-procedure instructions improves the quality of bowel preparation for     colonoscopy.   "
214019|NCT00645151|"     The purpose of this study is to determine the percentage of patients who would reach a     cholesterol goal after atorvastatin treatment.   "
213908|NCT00643695|"     In this study, depressed veterans with hepatitis C will be randomly assigned to the control     group or to the exercise intervention group. The exercise intervention is designed to begin     slowly for most participants and to progress within each participant's target heart rate     range for moderate intensity exercise. The exercise intervention is a 12 week home based     walking program. Ideally individuals will walk for 30 minutes, at a moderate intensity, a     minimum of three times per week. However, the duration and relative intensity will be     tailored for each individual.      Central Hypothesis Veterans who receive the exercise intervention will be significantly less     symptomatic for depression than veterans in the control group.   "
213909|NCT00643708|"     BACKGROUND: A new effective way, transvaginal ultrasound-guided ovarian interstitial     laser-coagulation treatment, in management of anovulation in patients with polycystic ovary     syndrome (PCOS), has been presented in the data published. But, the optimal number of laser     coagulation points in the ovarian interstitial to be applied at the procedure is unclear.     This clinic trial aims to explore an optimal laser dose for this new protocol. METHODS:     Fifty-six PCOS women with clomifene citrate-resistant underwent ultrasound-guided     transvaginal ovarian interstitial YAG-laser treatment. By random list table，all subjects were     randomly divided into four groups in terms of the number of laser coagulation points made in     their ovaries as follows: group A, one coagulation point per ovary; group B, two points;     group C, three points; group D, four to five points. The size of each point was about 10 mm     in diameter on the ovarian plane monitored by transvaginal ultrasound. Postoperative     ovulation rate, pregnancy rate and some biochemical parameters were compared among four     groups.   "
213911|NCT00643734|"     The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release     (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the     treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and     safety of both treatment regimens.   "
213912|NCT00643747|"     The purpose of the study is to determine whether gene therapy is safe and effective for the     treatment of severe childhood blindness caused by mutations in RPE65.   "
213913|NCT00643760|"     The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262),     hereafter referred to as GEn is effective in the treatment of neuropathic pain associated     with diabetic peripheral neuropathy(DPN)   "
213914|NCT00643773|"     The purpose of this study is to determine whether long term leucine supplementation has a     positive effect on body composition and muscle characteristics in elderly, type 2 diabetes     patients.   "
213915|NCT00643786|"     The usefulness of re-oxygenation after inhalation of 50% nitrous oxide and 50% oxygen premix     (Kalinox 170 bar) during dental care is studied and the pollution resulting from     administration of Kalinox is also investigated.   "
213916|NCT00643799|"     To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee     osteoarthritis   "
213917|NCT00643812|"     Rates of suicide among young Alaska Native males are over ten-fold higher than among a     similar age cohort in the rest of the United States. A high proportion of these deaths are     associated with firearms. Firearms are an important part of the subsistence lifestyle of this     population, however restriction of access to guns by youth may be a promising strategy to     reduce the risk of suicides in this population. Previous research conducted in the first     phase of this project has demonstrated that about 75% of homes in rural southwest Alaskan     villages have guns, and only about 15% of these guns are locked; 6% are loaded.      The aims of this specific phase of the study to execute a randomized trial of an intervention     to improve firearm storage practices among residents of selected villages. Our hypothesis is     that households receiving training and equipment to store firearms in gun lockers will be     more likely to store their guns locked at 12 months, compared to households not receiving the     intervention.   "
213918|NCT00643825|"     This study will test the hypothesis that prolonged adjuvant Temozolomide (TMZ) may delay     relapses in patients with glioblastoma compared to the standard care consisting in     observation with brain MRI every 3 months and rechallenging with TMZ at relapse (Stop and Go     arm).   "
213919|NCT00643838|"     A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the     realization of dental cares. This openly clinical trial is done in 36 French primary care     dental centers, especially on anxious and phobic patients but also on infants or mental     deficient adults. At least 480 patients will be included in this clinical protocol.   "
213920|NCT00643851|"     The purpose of this clinical research study is to learn if initiating treatment with     BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in     patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes,     when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety     of this treatment will also be studied   "
213921|NCT00643864|"     The purpose of this project is to assess the effects of four weeks of mirror-box training on     weakness of one arm secondary to stroke. Primary measures are function and strength.     Secondary measures will evaluate muscle tone, flexibility, and the subject's perception of     their everyday function and improvement. Research Hypothesis: For chronic upper limb     hemiparesis secondary to stroke, four weeks of mirror-box training with movement of the     unaffected limb only results in a mean increase of 10 points on the Fugl-Meyer Test of Motor     Recovery (Upper Extremity).   "
213922|NCT00643877|"     The purpose of this study is to investigate whether preoperative hepatic and regional     arterial chemotherapy are able to prevent liver metastasis and improve overall survival in     patients receiving curative colorectal cancer resection.   "
213948|NCT00644215|"     purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and     MMC drop in management of early bleb failure .      Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after     filtering or combined surgery with MMC which don't respond to high frequent topical steroids     and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin     drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and     first and third month will be obtained.Patients will follow for at least 3 months and IOP     ,bleb configuration will check as primary outcome measures.Preoperative and postoperative     data,complications,and the need for further surgical procedures will be evaluated.   "
213923|NCT00643890|"     The purpose of this study is to determine the safety and efficacy of AAV-GAD gene transfer     into the subthalamic nucleus (STN) region of the brain. This study involves the treatment of     subjects with medically refractory Parkinson's disease (PD). The gene transfer product, a     disabled virus with a gene called GAD, will be infused into the STN bilaterally using     stereotactic surgical techniques. The overall goal of this approach is to normalize the     activity of the STN and reduce the motor symptoms of PD.      Because the change in UPDRS demonstrated a positive outcome, the sham surgery subjects from     the blinded portion of the study will be invited to crossover into the Open-label Arm portion     of the study. The Open-label Arm will further evaluate the safety and efficacy of AAV-GAD     gene transfer into the subthalamic nucleus (STN) region of the brain.   "
213924|NCT00643903|"     This study will evaluate the effectiveness of cognitive behavioral coping training in     improving side effect management and treatment adherence in HIV-infected patients who are     taking antiretroviral medications.   "
213925|NCT00643916|"     The purpose of this clinical trial is to describe the safety and immunogenicity of one or two     doses of Menactra® (TetraMenD) administered in children less than 2 years of age.      Primary Objective:      To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when     administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of     one dose of Menomune® when administered to children aged 3 years to <6 years of age.   "
214003|NCT00644943|"     The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7     mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based     on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months     and 6 years of age, with AOM.   "
213926|NCT00643929|"     A long term observational ocular safety study in adults who have received study medication     (either active drug or placebo) in a phase II or III clinical study evaluating eltrombopag.     The study will follow subjects for 2.5 years following their last ocular assessment on their     prior treatment study (regardless of the therapeutic indication) and will describe long-term     ocular safety with respect to changes in the lenses over time from all subjects.   "
213927|NCT00643942|"     The clinical objective of this study is to quantify the levels of corneal and conjunctival     staining in a healthy, non-dry eye population. This is a descriptive study without test     article administered.   "
213928|NCT00643955|"     Evaluation of muscle strength and central activation of muscle in individuals with Down     Syndrome   "
213929|NCT00643968|"     Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain     plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)      Main Secondary objectives:      Comparison of the two arms for genotypic resistance profile in case of virological failure      CD4 changes from baseline      Evolution of the lipid profile and morphological changes in fat distribution, and safety      Efficacy and genotypic profile data, results of lipid markers, morphological changes and main     biological parameters   "
213930|NCT00643981|"     The purpose of this research study is to determine if the infusion of a combination of stem     cells obtained from the bone marrow of the same patient will contribute to the formation of     new blood vessels in patients with symptomatic severe coronary ischemia. In this trial we     will study the safe use of this therapy and its effects on making new blood vessels will be     evaluated.      Coronary ischemia is intractable angina due to severe coronary artery disease which can     seriously decrease blood flow to the heart.      CI needs a comprehensive treatment since the condition will not improve on its own. The     overall goal of the treatment is to increase blood flow to the heart and improve symptoms of     angina.      The study hypothesis is based on the concept that the process of formation of new blood     vessels is complex and requires the participation of several types of stem cells and growth     factors. The lack of any of these components will produce vessels which are immature and     unable to provide appropriate blood supply to the heart.      Patients eligible to participate in this study are those suffering from severe blockages to     the vessels of the heart and are not candidates for percutaneous revascularization or     surgical procedures.      Once the final mixture of stem cells is prepared, the cells will be intracoronary infused     through a catheter into the blocked vessel of the heart.      Studies will be performed to evaluate if the intracoronary infusion of stem cells is safe,     feasible and works.      Patients will be evaluated for 6 months after cell transplant.   "
213931|NCT00643994|"     The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients     with early stage organ-confined prostate cancer.   "
213932|NCT00644007|"     The purpose of this study is to evaluate the efficacy and safety of SK3530 in men with ED and     hypertension who were taking antihypertensive medication.   "
213933|NCT00644020|"     The investigation is a randomized, double-blind, placebo involved and multi-center clinical     trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo     group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with     branch vein thrombosis. They receive investigational drug 40 days after resection surgery.     Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.   "
213934|NCT00644033|"     The primary objective of this study was to determine whether frovatriptan was effective in     the prevention of menstrually associated migraine (MAM) headaches when compared to placebo.     Secondary objectives included determining the effectiveness of frovatriptan in reducing the     incidence, severity and duration of MAM headaches and associated symptoms, to evaluate the     safety and tolerability of the two frovatriptan dosing regimens and to compare the     effectiveness of these regimens in the prevention of MAM headaches. In this cross-over study,     patients treated each of 3 perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg     daily (QD) and 2.5 mg twice daily (BID) for 6 days, starting 2 days before the anticipated     onset of a MAM headache.      A statistically significant reduction in the incidence of MAM headache (p<0.0001) was     observed with both dosing regimens of frovatriptan when compared to placebo. Additionally,     the frovatriptan BID regimen was superior to the frovatriptan QD regimen in the prevention of     MAM headache (p<0.001). Significant reductions in MAM headache severity and duration, the     incidence of associated symptoms and characteristics, and the use of rescue medication were     observed when the PMP was treated with frovatriptan, compared to placebo. Both dose regimens     of frovatriptan were equally well tolerated and no cardiovascular or other safety and     tolerability concerns arose with repeated administration of frovatriptan over a 6 day period.   "
213982|NCT00644657|"     This study will explore the effect of clopidogrel on coated-platelets in patients who are     given a loading dose before diagnostic catheterization or percutaneous coronary intervention.     We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and     therefore more hypercoagulable.   "
213935|NCT00644046|"     The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in     Taiwan (1, 2). More than 45,000 patients are under renal replacement therapy in the year 2004     (2). The disease had not only caused a significant impact in personal life, but also a great     burden on social security and government-run health insurance. However, despite this high     prevalence, the awareness of chronic kidney disease (CKD) in general population remains low     (3, 4). The patients always come out too late for the intervention to slow down the     progression of renal failure. Furthermore, most of them are not well prepared for the renal     replacement therapy. The facts result in high mortality and morbidity in this specific     population (5). It is mandatory to screen out and treat these patients early enough. However,     these patients are deep into the community as the asymptomatic nature of CKD.      The major purpose of the study is to screen the community for the early CKD and provide the     appropriate intervention at time. The study will collect the characteristic demographic     epidemiological data and find out risk factors for CKD of this geographic area, provide     multidisciplinary education of CKD and establish timely referral for appropriate nephrologist     care for treatment and monitoring of complications.   "
213936|NCT00644059|"     This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5     mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza     and non-adjuvanted influenza control vaccines in subjects 6 to <72 months of age.   "
213937|NCT00644072|"     Background:      SNX-5422 is an experimental drug that inhibits a protein called Hsp90, which is important for     the growth of tumor cells.      SNX-5422 has shown some activity against tumors in the laboratory and animal studies.      Objectives:      To determine the highest safe dose, or maximum tolerated dose (MTD), of SNX-5422 that can     safely be given to patients with solid tumor cancers and lymphomas when taken twice a week.      To learn how the body's blood and tissue cells react to SNX-5422.      To examine the effects of SNX-5422 on tumors and lymphomas.      Eligibility:      Patients 18 years of age or older who have solid tumor cancers or lymphomas that do not     respond to standard therapy or for whom no acceptable standard treatment is available.      Design:      SNX-5422 is taken by mouth twice a week in 28-day cycles. Treatment may continue as long as     the cancer does not worsen and side effects are acceptable. Three to six patients are     enrolled in the study at a time. Each group is given a higher dose of SNX-5422 than the     previous, as long as the preceding dose was tolerated and until the MTD is determined. When     the MTD is found, six more patients are enrolled at that dose level.      During the treatment period, patients undergo the following tests and procedures:        -  Clinic visits for a physical examination each treatment cycle to check on health status.        -  Blood tests for routine laboratory values, to determine how the body handles SNX-5422,          and to examine the effects of SNX-5422 on blood cells and other targets.        -  Urine tests as needed, depending on the results of blood tests.        -  CT scans, or other imaging tests every 8 weeks to evaluate the tumor response to          treatment.        -  Tumor biopsy (surgical removal of a tissue sample for examination under a microscope)          before the first dose of SNX-5422 and again 24 hours after the first dose to see how the          drug affects the tumor. This test is optional.   "
213938|NCT00644085|"     To investigate the effect of daily administration of low-dose aspirin, compared to placebo,     on IVF and ICSI outcome.   "
213939|NCT00644098|"     The purpose of this study is to investigate whether the addition of capsules containing     soluble fibre complex emulsified with medium chain triglycerides and taken before with meals     will lead to a significant amount of weight loss, reduced glycemic volatility and diminished     cardio metabolic risk factors in overweight and obese individuals when compared to a placebo     control.      We believe that those participants taking 3-6 capsules per day of the treatment capsules over     a 14 week period will loose a significant amount of weight compared to the placebo group.   "
213940|NCT00644111|"     Minimally invasive (MIS) lumbar decompression and fusion is a new procedure that aims to     reduce post-operative pain, opioid consumption and related side effects, and length of     hospital stay. Current research demonstrates a modest improvement in these areas beginning on     the third post-operative day. MIS fusion, however, incurs significant cost as the average     time of the procedure is approximately one third greater (from 148 minutes to 191 on     average). Epidural analgesia has clearly demonstrated benefits for conventional open     laminectomy. In order to fully maximize the benefits of an MIS technique, early     post-operative analgesia/pain must be improved. The aim of this study is to combine two     techniques to ultimately improve patient outcomes and satisfaction. This will be a randomized     trial involving 32 patients undergoing MIS decompression and fusion with half the study group     receiving active epidural and IV-PCA and the other half receiving epidural placebo and     IV-PCA.      The hypothesis is that epidural analgesia will reduce post-operative opioid consumption,     improve pain scores, and decrease time to ambulation as well as discharge from hospital after     MIS decompression and fusion.   "
213941|NCT00644124|"     The purpose of this study is to determine the selected dose of aflibercept when it is     combined with R-CHOP treatment (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone     +/- intrathecal Methotrexate) administered every 2 weeks or every 3 weeks, in non Hodgkin     B-cell lymphoma, and to determine how the body handles aflibercept when it is administered     with R-CHOP.   "
213942|NCT00644137|"     The goal of this study is to examine the effects of a GABA (gamma amino butyric     acid)-enhancing medication, pregabalin (300 mg/day), on smoking behavior, tobacco withdrawal     and cigarette craving in smokers. We hypothesize that in smokers, pregabalin at 300 mg/day,     will be more effective than placebo in decreasing smoking behavior and attenuating tobacco     withdrawal and cigarette craving.   "
213943|NCT00644150|"     This study will evaluate the effectiveness of a physician training program, the Ai Shi Zi     program, in improving HIV/sexually transmitted infection diagnosis, treatment, and management     by Chinese physicians and in reducing the number of subsequent infections in their patients.   "
213944|NCT00644163|"     This study will evaluate the effectiveness of a risk-reduction program in preventing the     transmission of HIV and sexually transmitted diseases among African-American heterosexual     couples, with one partner having been previously diagnosed with an HIV infection.   "
213945|NCT00644176|"     The objective of this trial was to characterize the pharmacokinetics of the currently     marketed azithromycin immediate release tablet formulation (AZ-IR) versus the azithromycin     sustained release liquid formulation (AZ-SR) in lung tissue and bronchial washings, the     latter consisting of the epithelial lining fluid (ELF) and cellular elements, mainly alveolar     macrophages (AM).   "
213946|NCT00644189|"     Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and     works in two different ways. It affects the development of new cancer cells by blocking two     enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call     can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing     cancer cells to die by disturbing components within the cancer cell. This causes the release     of a substance that is fatal to the cell.      This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin     lymphomas.   "
213949|NCT00644228|"     This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see     how well it works compared to dexamethasone and lenalidomide alone in treating patients with     previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may     stimulate the immune system in different ways and stop cancer cells from growing. Drugs used     in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether     lenalidomide and dexamethasone is more effective with or without bortezomib in treating     multiple myeloma.   "
213950|NCT00644241|"     India is the Diabetes Capital of the World with 41 million Indians having diabetes i.e.     every fifth diabetic in the world is an Indian1. Type 2 Diabetes Mellitus (T2DM) constitutes     the major chunk of diabetes and has insulin resistance as the hallmark feature in the     pathogenesis. However, with the progression of the disease the insulin resistance becomes     stable whereas β - cell function shows a gradual decline due to its ongoing apoptosis2. This     ultimately leads to inability of the β - cells to cope up with the increased demand of     insulin caused due to insulin resistance and manifests as hyperglycemia. As β - cell failure     is progressive and inexorable, as demonstrated in United Kingdom Prospective Diabetes Study3,     most of the patients with T2DM would eventually require insulin and it would be difficult to     achieve to attain a strict glycemic control . It is well known that diabetes related     complications which account for morbidity and mortality in this disease can be prevented or     delayed by strict glycemic control. However, even with intensive insulin therapy it has been     shown that glycemic control can never be perfect with patients exhibiting hyperglycemia or     hypoglycemia during 24 hour glucose profile4. Also insulin therapy is not physiological as     there is no hepatic first - pass metabolism of insulin which is required for halting the     hepatic glucose output, which is responsible for fasting hyperglycemia5. This led the     researchers to evolve various strategies of β - cell replacement therapy e.g. pancreatic     transplantation and islet cell transplantation. Initially the results of islet cell     transplantation were dismal but after the induction of glucocorticoid free immunosuppressive     therapy and the use of adequate number of islet cells from multiple donors, the results of     islet cell transplantation have been better6. However, islet cell transplantation has its own     limitations viz insufficient supply, being technically demanding and requirement of lifelong     immunosuppressive therapy in the recipient.      These shortcomings can be overcome by the use of stem cells which is an inexhaustible source     of β -cells. Stem cells are primitive cells capable of differentiating into mature cells of     the body of various lineages. Stem cells can be obtained from various sources like blastocyst     (embryonal stem cells), umbilical cord or bone marrow. There is an evidence to suggest that     stem cell transplantation can lead to improvement in pancreatic endocrine function and     improvement in glycemic control in diabetic mice7,8,9,10 through various mechanisms such as     transdifferentiation or regeneration of endothelial cell in the damaged islets which in turn     lead to regeneration of islet cells by paracrine action11. However, till date there is no     study that demonstrates that stem cell therapy can be effective in patients with T2DM for     their glycemic control.      The investigators propose to carry out autologous bone marrow - derived stem cell     transplantation (ABMSCT) in patients of T2DM, obtained from their own bone marrow and its     superselective injection into the gastroduodenal artery after purification without any     immunosuppressive regimen.      Aim:      The aim of this study is to reverse hyperglycemia and insulin dependency by ABMSCT in     patients with type 2 diabetes mellitus.      Hypothesis:      The investigators hypothesize that ABMSCT into the pancreas of patients with T2DM, aged more     than 30 years with insulin requirement of 0.7 U/ kg body weight/day or 50 U / day whichever     is lesser, will lead to abolition or reduction of insulin requirement by more than or equal     to 50% in these patients over a period of 6 months. It is assumed that ABMSCT will lead these     patients to regenerate functional β - cells by transdifferentiation or by regeneration of     endothelial cell which in turn cause β - cells neogenesis by paracrine effect.      Objectives:      Primary objective:        1. Abolition or reduction of insulin requirement by > 50% by the end of 6 months of ABMSCT.        2. To evaluate the increment of Glucagon stimulated C - peptide response at the end of 6          months of ABMSCT, as compared to the baseline values.      Secondary objective:        1. Any reduction in requirement of insulin dosage.        2. Improvement of HbA1c levels as compared to baseline.   "
213951|NCT00644254|"     Extracapsular lymph node involvement (ECLNI) has been identified as a pathological variable     associated with worse outcome in esophageal, gastric and colorectal cancer. No studies so far     have studied its prognostic impact in ductal pancreatic adenocarcinoma (DPAC). The goal of     the investigators is to determine the prognostic value of ECLNI in a prospective consecutive     series of 145 patients with DPAC, who underwent resection of their primary tumor between 1998     and 2005.   "
213952|NCT00644267|"     We have established a Telemedicine System for chronic disease management. Based on a personal     health record, we have successfully used this system in diverse populations, in over 600     patients, and in multiple disease states (heart failure, CVD risk reduction, gestational     diabetes). In this proposal, we will enhance this Telemedicine system to support patient     centered care (PCC) by increasing access, incorporating hypertension treatment guideline,     quality measures, automating reminders and feedback for both patients and health care     providers.      Inner-city, primarily African-American patients (N=252) with uncontrolled hypertension     (BP<140/90 mmHg) and who are followed by primary care physicians will be randomized to either     a usual care or a telemedicine group (Telemedicine plus usual care). Blood pressure, weight,     BMI, blood glucose and lipids, and physical activity will be measured at baseline and at 6     months. We hypothesize that more subjects in the telemedicine group will achieve goal blood     pressure than in the control group. This will occur through increases in knowledge,     self-management, shared decision-making, and improved doctor-patient interaction. Primary     end- point will be the proportion of subjects who achieve goal blood pressure. Secondary     end-points will include:      Rate of self-monitoring, steps per day, weight, CVD knowledge, number of patients at     medication guidelines, and increased satisfaction with practice. Telemedicine utilization     will also be determined. We believe that telemedicine can facilitate PCC and reduce blood     pressure in a cost effective manner.   "
213953|NCT00644280|"     To determine whether ranibizumab therapy before and after tube insertion for glaucoma     surgeries can maintain the patency of the tube and prevent scar formation, and increase the     chances for a successful procedure compared to observation.   "
213954|NCT00644293|"     To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day     course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and     adults with strep throat, and to assess efficacy and safety for both treatment regimens.   "
213955|NCT00644306|"     In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been     usedsince the 1960s and is regarded as the standard of care in very elderly patients. We     assess whether the addition of thalidomide at 100 mg/day to this combination would improve     survival.   "
213956|NCT00644319|"     RATIONALE: Morphine and ibuprofen help lessen pain caused by pleurodesis. It is not yet known     whether one drug is more effective than the other in lessening pleurodesis-related pain or     whether the size of the chest drain tube affects pain.      PURPOSE: This randomized clinical trial is studying ibuprofen to see how well it works     compared with morphine in treating pain in patients undergoing pleurodesis for malignant     pleural effusion.   "
213957|NCT00644332|"     According to the American Heart Association (AHA) 2011 update of heart disease and stroke     statistics, more than 9 million adult patients in the United States (US) have angina. This     update also notes that a study of 4 national cross-sectional health examination studies found     that, among Americans 40 to 74 years of age, the age-adjusted prevalence of angina was higher     among women than men. Per ACC/AHA guidelines, the goal of antianginal therapy is the complete     or near complete elimination of anginal chest pain and a return to normal activities and     functional capacity. However, evaluating angina and responses to antianginal therapy is often     not straightforward. This is particularly true of female patients with angina. Because angina     and response to antianginal therapy may differ in men and women, an instrument designed     specifically to address symptomatology in women with angina could enhance our understanding     and characterization of angina and responses to therapy in this population. The current study     will evaluate the validity, reliability, and responsiveness of the newly developed Women's     Ischemia Symptom Questionnaire (WISQ) based on changes in angina symptomatology in a female     angina population treated with ranolazine, compared with the widely used Seattle Angina     Questionnaire (SAQ).   "
213958|NCT00644345|"     Microvolt T-Wave Alternans (MTWA) is a relatively new non-invasive method for identifying     patients at increased risk of sudden death from ventricular arrhythmias. MTWA can be measured     during a routine exercise test, during pharmacologic stress or during cardiac pacing. Its     clinical performance compares favorably with that of other non-invasive risk stratifiers and     invasive electophysiologic studies. The purpose of the present study is to define the     reproducibility of MTWA testing.   "
213959|NCT00644358|"     This open label 52-week clinical trial is designed to assess the safety and tolerability of     vilazodone and to analyze genetic markers of response to vilazodone in adult patients     diagnosed with MDD. This study will enroll approximately 600 patients.   "
213960|NCT00644371|"     To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative     conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic     transplantation of haematopoietic stem cells from family donor's peripheral blood.   "
213961|NCT00644384|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of acitretin may stop cancer from growing in patients at high risk for basal cell carcinoma     or squamous cell carcinoma of the skin.      PURPOSE: This randomized trial is studying how well acitretin works in preventing skin cancer     in patients at high risk for skin cancer.   "
213962|NCT00644397|"     Internal fixation of femur fractures improves alignment and provides stability to the bone     and the surrounding soft tissues. This generally allows for early motion of the adjacent     joints; thus maximizing overall function of the limb. Open reduction and internal fixation     with plates and screws is the standard method that has been used in the treatment of distal     femoral fractures. One common traditional method of internal fixation is the 95-degree angled     blade plate. Recent advances in technology for distal femur fractures include the LCP™     Condylar Plate. This implant differs from the blade plate, because the LCP offers multiple     points of fixed angle contact between the plate and screws in the distal femur. The     introduction of plates with the option of locked screws has provided means to increase the     rigidity of fixation in osteoporotic bone or in periarticular fractures with a small distal     segment, and the LCP may be technically easier to apply than the blade plate. To the     investigators' knowledge, there have been no published clinical or biomechanical studies     specific to the LCP Condylar Plate, although the early results of LCP implants for other     fractures are promising. The investigators believe that locked plating represents a valuable     advancement in fracture treatment. However, the limitations of this new technology and the     indications for its use have not been completely elucidated. Furthermore, the cost of the new     technology is approximately seven times more than the traditional treatment. This is a     randomized, prospective, multi-center study to compare the blade plate and the LCP in the     distal femur. All patients 16 years of age or older, regardless of race or gender, with a     supracondylar fracture of distal femur will be considered. Whether patients are treated with     a blade plate or/and LCP, they will be receiving standard orthopedic care for their injury.     Neither of these methods currently places a patient at increased surgical or post-surgical     risk for problems with infection, nonunion, malunion, or other complications. Because of the     study, early and late complication rates and functional outcomes after these treatments may     be better defined, allowing for optimization of care of people with these injuries in the     future. This should reduce not only direct and indirect costs to the individual, but also     costs to society.   "
213963|NCT00644410|"     It is a single centre, randomised controlled study of the effect of NOGA-guided direct     intramyocardial injection of mesenchymal stromal cells on the development of new myocardium     and blood vessels in patients with heart failure.      Stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before     injected into the myocardium.      The patients will be followed with safety, clinical, MRI and CT endpoints for 1 year.   "
213964|NCT00644423|"     An increasing literature shows that omega-3 fatty acids provide numerous health benefits,     including a variety of psychiatric symptoms and disorders including stress, anxiety,     cognitive impairment, mood disorders (major depression and bipolar disorder) and     schizophrenia. Omega-3 fatty acids may additionally represent a promising treatment strategy     in patients with PTSD. Moreover, given its beneficial cardiovascular effects, adjunctive     omega-3 fatty acids may also benefit the general health status of these veterans, who     frequently present with a variety of comorbid medical disorders.   "
213965|NCT00644436|"     To determine if Tetrix Cream remains on the hands after gentle washing with soap and water   "
213966|NCT00644449|"     This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least     as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of     chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of     both treatment regimens   "
213967|NCT00644462|"     The PulmoTrack® 2010 with WIM-PC™ Technologies device, indicated for acoustic pulmonary     function measurement that quantifies the presence of wheezing. This study was designed in     order to evaluate the efficacy and safety of using the WIM-PC™ device for wheeze detection     during dynamic bronchial situations in asthmatic adult.   "
213968|NCT00644475|"     BACKGROUND The effects of ACE-inhibitors on fibrinolysis are well documented. Experimental     and clinical studies have shown that ACE inhibitors induce a reduction in plasma PAI-1 levels     in many cardiovascular diseases, like hypertension, coronary heart disease, and heart     failure. Their effects on t-PA are more controversial, due to the fact that t-PA exists in     several forms, including free and bound to PAI-1. Indeed an increase in t-PA activity has     been observed in humans and it seems related to bradykinin increase which is known to     stimulate endothelial t-PA synthesis. These favourable effects on fibrinolysis could be     related not only to the Angiotensin II reduction and the bradykinin increase but also to the     improvement in insulin sensitivity, as insulin has been suggested as one of the main     regulators of fibrinolytic activity.      To date conflicting results have been reported about the effects of ARBs on fibrinolysis.     Some studies have reported small improvements, others no significant effect. These     conflicting results may be due to possible methodological bias but a possible     pathophysiological explanation might be that receptor subtypes other than AT1 mediate the     effect of Angiotensin-II on endothelial PAI-1 expression, i.e. the AT4 receptors, and during     AT1 receptor blockade there is an important increase not only of Angiotensin-II, but also of     all its catabolites including Angiotensin IV. The dissimilar effects on of ACE Is and ARBs     may also depend on their different action on the RAS and their different effect on insulin     sensitivity: ACE-Is improve insulin sensitivity, while the majority of ARBs have been     reported to have a neutral effect. Moreover, unlike ACE-Is, ARBs do not affect the metabolism     of bradykinin, which is known to stimulate t-PA synthesis and release.      AIM OF THE STUDY The aim of this study is to verify the effect of imidapril compared to     candesartan on insulin sensitivity, evaluated through the euglycemic hyperinsulinemic clamp,     and on fibrinolysis, evaluated through the plasma PAI-1 and t-PA activity, in mild to     moderate hypertensive patients.   "
213969|NCT00644488|"     The purpose of this clinical study is to assess the safety and tolerability of BMS-641988     once daily orally in Japanese patients with castration resistant prostate cancer   "
213970|NCT00644501|"     The study is an open-label extension study, offering patients who participated and completed     previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2     additional years. The expectation is first to demonstrate that extended treatment with     DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only     patients who completed the previous 2-year study and still have beta-cell function above a     threshold level will be eligible for this extension study.   "
213971|NCT00644514|"     The purpose of this study is to identify the mediators and genes in airway epithelial and BAL     cells that are differentially regulated following inhalation of endotoxin lipopolysaccharide     (LPS) among study participants with allergic asthma and normal phenotypes. This approach is     designed to identify novel genes associated with both asthma pathogenesis and asthma     susceptibility. LPS, or endotoxin, a cell wall component of gram-negative bacteria, is     ubiquitous in the environment, and is thought to influence both susceptibility and severity     of asthma.      240 subjects (healthy adult men and women (age >18-40) with and without atopy and asthma)     will complete the screening evaluations in order to establish 3 study groups of 60 subjects     each. Each qualified subject will undergo an inhaled LPS endotoxin challenge followed by     bronchoscopy after 24 hours, which will consist of a bronchoalveolar lavage (BAL) and     endobronchial brush biopsies. BAL involves squirting a small amount of sterile salt water     into one of the airways then gently taking it back out through the bronchoscope. The brush     sample involves gently moving a small brush back and forth in an airway to collect cell     samples. Samples of whole blood will also be obtained at various time points. RNA will be     isolated from these cell populations in order to assess differential gene expression     expression using microarrays.   "
213983|NCT00644670|"     The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering     cholesterol and getting these high risk patients to their goals of LDL <115 mg/dl across     starting doses of 10 mg, 20 mg, or 40 mg with one step titration.   "
214020|NCT00645164|"     The product is being tested to see if exposure to light causes photoallergic reactions on the     skin.   "
213984|NCT00644683|"     Premenopausal women who are diagnosed with breast cancer are frequently treated with     chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary     loss of menstrual periods to permanent menopause. It is difficult to predict how an     individual's ovarian function will be affected by chemotherapy. There are a number of     hormones which can be measured in the blood which are related to fertility and ovarian     function. The levels of these hormones may change with chemotherapy, and may relate to the     effect of chemotherapy on the ovaries.      In this study, we plan to enroll 28 women ranging in age from 25 to 50 who are diagnosed with     breast cancer and will be treated with chemotherapy. We will check blood levels of the     hormones before, immediately after, and 1 year after treatment with chemotherapy. We will     only be checking these blood tests for this study; the type of chemotherapy given will be up     to the patient and her oncologist. We will also ask some questions about factors that can     influence the levels of these hormones, such as number of children, age of menopause of other     family members, and smoking history. The results from this study will be used to help us     develop future studies looking at changes in ovarian function with chemotherapy, and the     effects of other breast cancer therapies, such as endocrine therapy, on the ovaries.   "
213972|NCT00644527|"     Depressive symptoms are highly prevalent in the population. According to data from a Zurich     longitudinal study, the lifetime incidence rate for severe depressive symptoms is 95%. Not     all persons with depressive symptoms, however, need psychotherapeutic, psychiatric or     pharmaceutical treatment. Many people specifically or unspecifically use music to influence     their mood and clinical evidence demonstrates that active involvement in music supports an     individual's treatment success during psychiatric therapy. The gray area of depressive     symptoms that do not require medical treatment, but which contribute to a considerable     disturbance of an individual's quality of life and ability to work, is the focus of the     proposed study.      The study investigates whether listening to specific music programs arranged to influence     depressive symptoms for 30 minutes in the morning and 30 minutes in the evenings can result     in improvement of an individual's symptoms, as compared to listening to no prescribed music     or no music treatment at all. Of specific interest is the use of music in the evening, which     may contribute to the achievement of restive sleep.      The study's objective is to determine if the utilization of two specific music therapies to     treat depressive symptoms, compared to a waiting list control intervention and an     intervention listening to Mozart over a 5 week period, leads to an improvement of the     depressive pathology among patients with moderate depressive disorders or patients with     dysthymia. The study is designed as a simple blinded placebo-controlled study.   "
213973|NCT00644540|"     The purpose of this research is to evaluate the immunogenicity of a single dose of Influenza     Vaccines (0.5mL or 0.25mL) in healthy children aged up to 35 months or 36 up to 48 months. To     evaluate the safety and tolerability of a single 0.25mL IM of injection influenza vaccines in     healthy children aged up to 35 months; to evaluate the safety and tolerability of a single     0.50mL IM injection of influenza vaccines in healthy children aged up to 48 months.   "
213974|NCT00644553|"     To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin     extended-release tablets (2 x 500 mg QD) with that of a 14-day course of     amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects     with Acute Bacterial Sinusitis (ABS).   "
213975|NCT00644566|"     Due to the shortage of child psychiatrists and the high prevalence of child mental health     disorder, pediatricians and other pediatric primary care providers often assume     responsibility for the management of various psychiatric disorders, including ADHD, Attention     Deficit Hyperactivity Disorder. However, pediatricians have not been well-trained during     residency to deal with the complexities of ADHD management. In addition, the system of care     under which pediatricians practice do not afford the time availability that is required to     properly manage a child with ADHD. On the other hand, if a pediatrician wishes to refer a     patient to a child mental health specialist, many obstacles, including but not limited to     stigma, insurance issues, and long waiting lists, often interfere with the patient actually     receiving services for his/her ADHD. This research project seeks to examine an innovative     model of care in which a child psychologist is located on the premises of a pediatric office     and is available to share the care of patients with the pediatrician in order to address     ADHD. We hypothesize that parents as well as pediatricians will be more satisfied with this     model of care and that patients will ultimately have better outcomes. The beginning of our     pilot has shown under-identification to be a barrier to care as well, and thus we propose to     implement a quality improvement initiative to screen children for psychosocial issues as     well. As we have had trouble with recruitment and unfortunately have had more children     randomized to TAU than shared care, we propose in December 2007 a phase 2 of our study where     all subjects, instead of randomization, are entered into shared care.   "
213976|NCT00644579|"     As many as 85 % of renal transplant patients may suffer from viral warts with a high degree     of treatment resistance. Promising results of hLAC (human lactalbumin complex with lipid)     point to a beneficial effect without noticeable side effects of bLAC (bovine lactalbumin     complex with lipid). The aim of first clinical trial with bLAC is to show proof of concept in     treatment of cutaneous wart lesions on hands and/or feet after local administration of bLAC     in two dose groups to immune suppressed, kidney transplanted patients.   "
213977|NCT00644592|"     This is a research study of how a cholesterol medication known as fenofibrate works     differently in people with different genetic backgrounds. Genetics refers to certain things     that are passed to a person by their parents, such as eye color or hair color. Genetic     differences lead to people having different eye and hair color. There are also genetic     differences in a protein called liver X receptor-alpha (LXRA), which may be important in     predicting the response to fenofibrate.   "
213978|NCT00644605|"     To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day     [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and     tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension     who are aged 18 years and over. To investigate the plasma concentration-effect relationship     and to determine the population pharmacokinetic (PK) parameters.   "
213979|NCT00644618|"     For patients with unresectable locally advanced pancreatic cancer, the combined use of     external-beam radiation therapy (EBRT) and systemic chemotherapy of 5-FU has been widely     recognized as the most effective chemoradiotherapy approach.But most patients succumb to     local recurrence and metastasis after treatment, and the prognosis remains poor On the basis     of the development and superiority of the interstitial brachytherapy and the radiosensitizing     effect of gemcitabine, we performed a clinical study to explore the interaction of improved     I-125 brachytherapy and gemcitabine and compare the regimen to the standard gemcitabine     treatment specifically in patients with non-metastatic, unresectable pancreatic cancer.   "
213980|NCT00644631|"     To compare the effects of sildenafil versus placebo on the female partner's sexual     satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject     Questionnaire (FePEDS-Q): Over the past 4 weeks, when you had sexual intercourse, how often     was it satisfactory for you? For ED subjects, determine difference in the Erectile Function     domain of International Index of Erectile Function (IIEF) between sildenafil citrate and     placebo at end of the treatment phase and determine the overall relationship between improved     erectile function and increased ED subject and female partner satisfaction.   "
213981|NCT00644644|"     -  Reduction in time to detection of Clinically Significant events        -  Reduction of time to Intervention during Clinically Significant events        -  Reduction in the number of admissions to Intensive Care   "
213985|NCT00644696|"     This Phase One pediatric trial seeks to take advantage of the susceptibility of neuroblastoma     to proteasome inhibitors, proven in vitro, along with the proven in vitro synergy of     bortezomib with irinotecan and the successful Phase One pediatric trials of bortezomib to     create a treatment using these two drugs in combination to treat refractory/recurrent     neuroblastoma in children and young adults 25 and under.   "
213986|NCT00644709|"     A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high     cardiovascular risk at the LDL cholesterol goal of <115 mg/dL   "
213987|NCT00644722|"     New single use laryngoscope metal blades are available for intubation. This type of blade is     safer than the reusable ones concerning the interhuman cross infection risk. No clinical     studies have compared the two types of blades in the emergency context. The primary aim of     this study is to demonstrate that single use blades are as efficient as the reusable ones     concerning intubation conditions.   "
213988|NCT00644735|"     A study to look at the rates of remission (non re-appearance of erosive esomeprazole) when     treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that     is in remission (i.e. previously healed EE).   "
213989|NCT00644748|"     The purpose of this study was to evaluate the efficacy, safety, and tolerability of     gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of     life of all treated patients was also assessed.   "
213990|NCT00644761|"     Open-label pharmacokinetic drug interaction study.   "
213991|NCT00644774|"     To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and     azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.   "
213992|NCT00644787|"     The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day     application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so     the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl     1-day application transdermal patch to fentanyl 3-day application (JNS005) transdermal patch     in participants with cancer pain.   "
213993|NCT00644800|"     To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the     treatment of the acute exacerbation of non-organic psychosis of any etiology, including     schizophrenia, acute mania, delusional disorder and others.   "
213994|NCT00644813|"     A significant subset of patients with scapula fractures also involves the glenoid neck (bone     joining the shoulder joint the scapular body). There is little evidence pertaining to the     best treatment or precise definition of these lesions. This study will be designed as a     prospective, non-randomized cohort study that will collect outcome and radiological data on     patients who have sustained a fracture of the glenoid neck (bone joining the shoulder joint     the scapular body) for a period of 1 year. All patients who have sustained extraarticular     scapula fractures (any fracture not involving the glenoid surface) will be considered.     Information will be collected with respect to the radiographic characteristics of osseous     injuries as well as functional outcome over time.   "
213995|NCT00644826|"     The purpose of this study is to determine whether preventive home visits for people aged 80     and over are effective in the prevention of nursing home admission in Germany.   "
213996|NCT00644839|"     Experiment in the test tube indicated that CP-945,598 becomes less soluble with increase of     pH (less acidity). Changes in stomach acid levels may affect the solubility of CP-945,598,     therefore, alters its availability in the blood. Omeprazole decreases acid levels in stomach.     This study will compare the time course of drug concentrations in the body, safety, and     tolerability of CP-945,598 given with and without omeprazole.   "
213997|NCT00644852|"     The purpose of the study is to evaluate the characteristics, clinical responses, and safety     issues of patients receiving long-term treatment of Risperidone long-acting injectable. The     goal is to evaluate patient outcomes based on pre-existing risk or disease factors and past     medication use.   "
213998|NCT00644878|"     This exploratory study will evaluate the change in molecular response in chronic myelogenous     leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal     molecular response to imatinib   "
213999|NCT00644891|"     To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin     oral antibiotic suspension medications in pediatric subjects. It was designed to determine if     Omnicef or amoxicillin is preferred to the other with regard to taste or smell.   "
214015|NCT00645099|"     The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and     olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids     (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density     lipoproteins (HDL)) in the blood as the primary parameter. Approximately 456 adult patients     will participate in this study.   "
214016|NCT00645112|"     To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5     days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a     total of 5 days, in children between 6 months and 6 years of age, with AOM.   "
214737|NCT00660478|"     Randomized clinical comparison of the serolimus eluting Cypher stent and the zotarolimus     eluting Endeavor stent.   "
214000|NCT00644904|"     Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at     risk and with MS have relatively low Vitamin D levels compared to their normal counterparts.      This trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of     40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS     characteristics will be divided into two groups: one group receiving the high dose Vitamin D     regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that     patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events     and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher     doses will demonstrate improved relapse and disability status compared to controls, and that     the treatment group will show improved markers of bone health and immune indicators of     reduced inflammation.   "
214001|NCT00644917|"     The product is being tested to see if exposure to light causes toxic reactions on the skin.   "
214002|NCT00644930|"     Background and objective: To determine the efficacy of non-invasive positive pressure     ventilation (NPPV) and its effects upon intubation rate and mortality in ARDS.   "
214004|NCT00644956|"     The objective of this study was to determine and compare the minimum time required to achieve     penile rigidity greater than or equal to 60% at the base of the penis that is sustained for     at least 3 minutes measured by Rigiscan®, following visual sexual stimulation post dose of     100 mg sildenafil citrate and 20 mg tadalafil in men with erectile dysfunction (ED).   "
214005|NCT00644969|"     Study will determine whether patients with schizophrenia or schizoaffective disorder can be     helped to quit smoking safely while using varenicline and receiving smoking cessation     counseling.   "
214006|NCT00644982|"     To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality     of life.   "
214007|NCT00644995|"     This randomized pilot study will evaluate the feasibility and acceptability of a phone-based     wellness program for improving mood, physical activity, and smoking abstinence rates among     people with depression who also are physically inactive and smoke cigarettes.   "
214008|NCT00645008|"     Undergoing cardiopulmonary bypass surgery and the subsequent admission to the intensive care     unit (ICU) is known to be a stressful event to the patient. As patients prepare for     open-heart surgery it is natural for them to feel anxious and concerned about all the various     procedures involved in the process. Members of both the surgical and anesthesia team explain     the purpose of each procedure and all issues associated with the procedures in great detail     in order to better prepare the patient, ease their anxiety and aid their recovery.      The underlying assumption for past investigations into overall patient satisfaction has been     that the stressors inherent in the experience of illness and hospitalization have an adverse     effect on patient recovery and can possibly prolong the recuperative process. Previous     studies have shown that the specific performance of a team in regard to the effects of the     stressors on the patient's status is key to providing optimal patient care in the ICU     environment. Since the ICU stay is a difficult experience in the life of a patient, stressor     predictability might allow for better physical and psychological conditions for the patient's     recovery.      Although there is a myriad of published research available on the potential stressors related     to an ICU stay, there is a dearth of investigation into the inherently more intense     circumstances surrounding a stay in the Cardiothoracic Intensive Care Unit (CT-ICU). By     examining the stressors in the CT-ICU changes can be made by the medical care team and/or     hospital that can ultimately enhance the patient experience in the CT-ICU.      The purpose of this study is to reduce or completely eliminate stressors present in the     CT-ICU as identified by the cardiac bypass patient. Identification of events and conditions     considered stressful in the ICU will allow the professional team to determine which stressors     are amendable to intervention and tailor patient care accordingly.   "
214009|NCT00645021|"     CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect     its elimination from the body via metabolism. This study will therefore compare the     pharmacokinetics (time course of drug concentrations in the body), safety, and tolerability     of CP-945,598 in patients with mild and moderate hepatic impairment and healthy control     subjects.   "
214010|NCT00645034|"     To investigate the effects of a single dose of sildenafil (100 mg) or placebo on blood     pressure and pulse rate in subjects taking doxazosin for benign prostatic hyperplasia (BPH).     To investigate the pharmacokinetics of doxazosin when co-administered with sildenafil 100 mg,     and to investigate the safety and toleration of sildenafil 100 mg when co-administered with     doxazosin.   "
214011|NCT00645047|"     Post-Traumatic Stress Disorder (PTSD) is considered a major public health problem in the U.S.     due to its high prevalence and high rates of disability associated with the disorder. For     thousands of veterans, PTSD is a chronic disorder, resulting directly from military service     that causes substantial psychological suffering and social disability. Barriers to PTSD care     include poor access, mistrust, and lack of benefit from traditional treatments. This project     addresses two very important and timely questions. First, can telemedicine be used as a tool     to extend effective, specialized mental health services such as, cognitive processing therapy     (CPT), to veterans with poor access to care? Second, does therapy delivered by telemedicine     effect the quality of care in terms of clinical outcomes (PTSD severity, Quality of Life),     and the quality of patient-therapist interaction (patient satisfaction & communication)? By     answering these questions, this study will provide valuable knowledge for VA researchers,     clinicians, and policy makers. The study findings will have direct implications related to     making specific recommendations regarding telemedicine utilization to deliver specialized     mental health services for veterans suffering from PTSD.   "
214012|NCT00645060|"     RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 DOTA anti-CEA monoclonal     antibody M5A, can find tumor cells and carry tumor-killing substances to them without harming     normal cells. This may be an effective treatment for advanced cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 DOTA     anti-CEA monoclonal antibody M5A in treating patients with advanced solid tumors.   "
214013|NCT00645073|"     To compare the safety and efficacy of a ten-day course of therapy of cefdinir, 600 mg QD, to     a ten-day course of therapy of levofloxacin, 500 mg QD, in the treatment of acute bacterial     sinusitis.   "
214014|NCT00645086|"     To compare the efficacy of a 5-day course of clarithromycin extended-release tablets (2 x 500     mg QD) with that of a 7-day course of clarithromycin immediate-release tablets (1 x 500 mg     BID) in the treatment of acute bacterial exacerbation of chronic bronchitis.   "
214021|NCT00645177|"     The purpose of this study is to determine the effect of ABT-869 plus paclitaxel compared to     paclitaxel alone on disease progression in metastatic breast cancer.   "
214022|NCT00645190|"     The purpose of this randomized, double-blind, active-controlled, flexible dosage, multicenter     study is to evaluate the effectiveness and safety of galantamine tablet (16-24mg/day) for 16     weeks in the treatment of mild to moderate Alzheimer's Disease (AD) comparing with Donepezil.   "
214023|NCT00645203|"     To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months     and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent     otitis media.   "
214024|NCT00645216|"     CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity     of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare     the time course of drug concentrations in the body, safety and tolerability of CP-945,598     given with or without grapefruit juice in healthy obese/overweight subjects.   "
214025|NCT00645229|"     The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute     exacerbation of schizophrenia or schizoaffective disorder, including patients with recent     onset of symptoms   "
214026|NCT00645242|"     The purpose of this study is to evaluate the safety and efficacy of fluconazole for the     treatment of tinea capitis in pediatric patients aged 3 to 12 years.   "
214027|NCT00645255|"     The study was designed to evaluate the long term efficacy and safety of Meridia 15 mg daily     in obese subjects.   "
214028|NCT00645268|"     To determine the effect on erectile function in a population of type 2 diabetic men with     erectile dysfunction who have undergone the following treatment regimen: pre-treatment with a     daily dose of double-blind sildenafil versus placebo for 4 weeks (Phase I) followed by an     as-needed, flexible-dose, open-label treatment phase with sildenafil for 12 weeks (Phase II).     To assess safety and tolerability of this dosing regimen and to investigate its effects on     endothelial function and subject's responses to the Self-Esteem And Relationship (SEAR)     questionnaire.   "
214029|NCT00645281|"     The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting     the primary symptom or complaint of patients with OAB.   "
214030|NCT00645294|"     Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents     infected with chronic hepatitis B.   "
214031|NCT00645307|"     The purpose of the study was an Open Label Extension to the recurrence prevention study to     evaluate long-term safety and tolerability of paliperidone ER in subjects with schizophrenia.   "
214032|NCT00645320|"     The purpose of this study is to evaluate the efficacy and tolerability of ziprasidone in     patients who successfully completed a study of ziprasidone treatment of psychosis (Protocol     A1281074).   "
214033|NCT00645333|"     New and better therapies for locally advanced and metastatic breast cancer are needed     because, even if standard treatment is successful in shrinking the cancer, there is still a     high chance that the cancer will recur. Recent research suggests that breast tumors have a     small number of cells in them that are breast cancer stem cells, which are very resistant     to standard treatment. It is thought that the reason that many patients cannot be cured of     their breast cancers is that the stem cells are unable to be killed and remain in the body     after standard treatment. Laboratory research has shown that a new drug, MK-0752, can target     stem cells and prevent tumor recurrences when the drug is combined with docetaxel, a     chemotherapy drug commonly used to treat breast cancer.      We know that MK-0752 is safe when given by itself to people. We do not know if treatment with     MK-0752 and docetaxel combined is safe or if it will kill breast cancer stem cells in     people with breast cancer. This clinical trial is being done to determine the safety of     several doses of MK-0752 in combination with docetaxel. Preliminary data about the     effectiveness of MK-0752 in combination with docetaxel will be collected. Also, tumor biopsy     samples will be taken from some patients who have tumors that can be easily biopsied. The     samples will be used to perform research tests to help determine if the breast cancer stem     cells are being killed by the drug combination.   "
214034|NCT00645346|"     The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity     of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect     humans from infection.   "
214035|NCT00645359|"     This research study is designed to test whether the results of a diffusion MRI scan performed     after one cycle of chemotherapy for lymphoma can accurately predict the outcome of treatment     for individual patients.   "
214036|NCT00645372|"     The purpose of this study is to compare the efficacy and safety of ziprasidone and     risperidone for the treatment of schizophrenia in Chinese patients   "
214037|NCT00645385|"     Subjects with newly diagnosed brain tumors who undergo surgical resection and whose pathology     in the operating room shows a high grade glioma will be eligible.      During a screening visit, the study will be discussed, inform consent discussed and signed, a     medical history will be taken and a physical examination and laboratory tests will be     performed. If these tests are all within acceptable ranges, the subject will be considered     for inclusion on this treatment protocol. If the results of any tests are extremely different     from normal expected values, she/he may not be able to participate.      Prior to surgery, the subject will have a contrast enhanced MRI and MRS. The neurosurgeon     will attempt to remove the majority of the tumor in the operating room and will send a     portion of the specimen removed to the pathologist immediately. This is called a frozen     section. If the pathologist believes that the tumor is a high-grade malignant brain tumor,     then the surgeon will place up to 8 dime-sized chemotherapy wafers in the tumor cavity of the     brain. The remainder of the tumor specimen will be given to the pathologist to review more     closely in the laboratory. If the frozen section does not show that the tumor is a high-grade     malignant brain tumor, the subject will not receive the Gliadel wafers and will be removed     from the study. The surgeon will then discuss with the subject the appropriate treatment     options for the disease he or she has.      During recovery in the hospital, another contrast enhanced MRI will be performed within the     first 72 hours after surgery. This is a standard of care for patients who are not involved on     this protocol as well. The subject will have another contrast enhanced MRI and MRS performed     at the 21st Day after his or her surgery. After Day 21, He or she may begin other forms of     treatment. The last contrast enhanced MRI and MRS assessment will be performed 12 weeks after     the surgery and the implantation of the Gliadel wafers. Further MRI and MRS may be performed     subsequently at the discretion of the doctor.      Throughout the course of treatment, clinical data will be collected.   "
214038|NCT00645398|"     The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo     for the symptomatic relief of pain associated with fibromyalgia. If this objective is met,     then the second objective will be to evaluate the efficacy and safety of pregabalin versus     placebo for the management of fibromyalgia (pain, patient global assessment, and functional     status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to     improve sleep, fatigue, and mood disturbance associated with fibromyalgia.   "
214147|NCT00655421|"     A feasibility study to compare the test characteristics of three different oral cancer     screening techniques performed by trained primary health care workers:1)Unaided Visual     Inspection, 2)VelScope Assisted Examination, and 3) Examination after application of     Toluidine Blue dye.   "
214039|NCT00645411|"     The present study is the first study designed to evaluate safety, tolerability and     immunogenicity of the cell culture-derived influenza vaccine in healthy children and     adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and     safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to     enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3     to 8 years of age (Cohort 3).   "
214040|NCT00645424|"     The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the     treatment of Taiwanese patients with diabetes and high cholesterol.   "
214041|NCT00645437|"     The primary objective was to evaluate the pharmacokinetics and safety of two dosing regimens     of levofloxacin in patients with varying degrees of renal function.   "
214042|NCT00652821|"     To compare the relative bioavailability of Kali and Ortho-McNeil's products   "
214128|NCT00655174|"     The purpose of this study is to determine if fluvoxamine or sertraline reduce the fequency or     severity of aggressive behaviour, obsessive symptoms, or anxiety in young children with     autism. The within-patient variability in this patient population using standard     neuropsychological instruments will also be determined and a predictor model for SSRI     responsitivity based on baseline neuropsychological testing will be developed.   "
214043|NCT00652834|"     The purpose of this study is to learn more about symptoms and gastrointestinal lesions     associated with taking myfortic® by switching patients to a delayed release formulation that     is developed to alleviate GI symptoms. A comparison of the frequency and severity of GI     symptoms observed in patients treated with MMF (cellcept®) after conversion to myfortic® will     be measured by using a self-assessed questionnaire called Gastrointestinal Symptom Rating     Scale (GSRS). To prove the incidence and improvement of GI lesions in patients treated with     MMF (cellcept®) after conversion to myfortic® will be measured by using Small Bowel Capsule     Endoscopy (SBCE).   "
214044|NCT00652847|"     To compare the percent (%) change in plasma LDL-C concentration, after a six week course of     treatment with ezetimibe 10 mg/day co-administered with an existing statin versus doubling of     the existing statin dose   "
214045|NCT00652860|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. GM-CSF may stimulate     the immune system in different ways and stop tumor cells from growing. GM-CSF, given by     inhalation, may interfere with the growth of tumor cells and prevent metastases from forming.     Radiation therapy uses high energy x rays to kill tumor cells. Giving combination     chemotherapy together with radiation therapy and GM-CSF before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed. Giving these     treatments after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with radiation therapy and GM-CSF before and after surgery works in treating patients with     stage III soft tissue sarcoma that can be removed by surgery.   "
214046|NCT00652873|"     To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus     Dostinex (reference)   "
214047|NCT00652886|"     -To compare the single dose bioavailability of Kali and BTG   "
214048|NCT00652899|"     RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, and total-body     irradiation before a donor natural killer cell infusion helps stop the growth of tumor cells.     It also helps stop the patient's immune system from rejecting the donor's natural killer     cells. Aldesleukin may stimulate the natural killer cells to kill ovarian, fallopian tube, or     primary peritoneal cancer cells. Treating the donor natural killer cells with aldesleukin may     help the natural killer cells kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving laboratory-treated donor natural     killer cells together with aldesleukin works when given after cyclophosphamide, fludarabine,     and total-body irradiation in treating patients with recurrent and/or metastatic ovarian,     fallopian tube, or primary peritoneal cancer.   "
214049|NCT00652912|"     To compare the single-dose bioavailability of Clonazepam ODT 1 mg and Klonopin Wafers 1 mg     ODT   "
214050|NCT00652925|"     To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such     as pain and swelling.   "
214051|NCT00652938|"     Infection with human papillomavirus (HPV) has been clearly established as the necessary cause     of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and     thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical     cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent     vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and     safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18     L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.   "
214052|NCT00652951|"     The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal     conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a     three-dose primary immunisation course during the first 6 months of life and as a booster     dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on     nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two     years of life will also be assessed. The Protocol Posting has been updated in order to comply     with the FDA Amendment Act, Sep 2007.   "
214053|NCT00652964|"     Detect the PHOX2B Mutation-confirmed congenital central hypoventilation syndrome   "
214054|NCT00652977|"     The aim of the investigation was to assess whether routine use of the modified Ritgen´s     maneuver decreases the risk of anal sphincter injury at delivery, compared with simple manual     protection of the perineum.Ritgen´s maneuver means that the fetal chin is reached for between     the anus and the coccyx and pulled anteriorly, while using the fingers of the other hand on     the fetal occiput to control speed of delivery and keep flexion of the fetal neck.   "
214055|NCT00653003|"     To compare the single-dose Bioavailability of Kali and Aventis   "
214056|NCT00653016|"     The purpose of this study is to document the experience of transdermal contraceptive patch     over a period of 9 cycles, compared to their previous contraceptive method.   "
214125|NCT00655135|"     The objectives of this study were to assess the safety and tolerability of LDP-02 in patients     with active Crohn's disease who were not receiving corticosteroids or immunosuppressives, to     assess the ability of LDP-02 to reduce Crohn's disease activity, and to obtain     pharmacokinetic (PK) and pharmacodynamic(PD)information for LDP-02 in patients with active     Crohn's disease.   "
214171|NCT00655733|"     Double-blind, randomized, multicenter, placebo-controlled study The purpose of this study is     to evaluate the efficacy and safety of HMPL-004 in patients with active moderate Crohn's     Disease,compared with placebo.   "
214087|NCT00654641|"     Wound complications after Cesarean section (C-section) are common in obese women.     Approximately 25% of obese women having a C-section will have a wound complication. This     research study is designed to assess whether applying a source of vacuum (suction) to the     wound can reduce the risk of wound complications. The investigators plan to enroll 220 women     into the study.      Women will be randomly selected to receive standard stitching and stapling of the incision     (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be     seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of     wound complications in each group will be compared. If the wound suction technique is     successful in preventing wound complications, this may substantially reduce pain and     suffering in a large number of women undergoing C-section for delivery.   "
214088|NCT00654654|"     The purpose of this study is to evaluate the safety profile and the treatment effect of     autologous human fibroblasts and placebo when administered to facial wrinkles and creases   "
214057|NCT00653029|"     Approximately 1.1 million people a year suffer a mild traumatic brain injury (MTBI), or     concussion, in the United States. Although most MTBI patients fully recover, as many as 28%     have physical, cognitive, and/or emotional symptoms up to 6 months post-injury. When symptoms     persist past three months, it is known as post-concussion syndrome (PCS). The cause of PCS is     unknown, as structural neuroimaging and neuropsychological (NP) testing results are often     normal. However, recent functional magnetic resonance imaging (fMRI) research in concussed     adults showed differences in brain activity compared to controls on working memory tasks,     despite normal structural MRI and neuropsychological findings. We propose improving this     research by assessing brain activation patterns during simple versus complex attention and     working memory tasks in 10 concussed adults via fMRI. This will be the first study to examine     brain activation patterns associated with the degree of effort applied to testing, a factor     known to confound interpretation of NP test performance. Validated computerized measures of     selective attention (Modified Stroop Interference Task), working memory (n-back), and effort     (Green's Medical Symptom Validity Test; MSVT) will be used. Ten paid controls will be used     for comparative purposes. We hypothesize that concussed patients will show less brain     activation than controls on complex versus simple working memory tasks and that activation     patterns in concussed patients will generally be lower in those with suboptimal effort. We     will also characterize self-reported emotional and physical symptoms in the PCS patients,     which has not been done in prior fMRI research with this population.   "
214058|NCT00653042|"     The purpose of this study is to assess the effects of nesiritide compared to placebo when     given with standard of care therapies, on kidney function, heart function and the need of     other treatments in heart failure patients undergoing heart bypass graft surgery that     requires the use of a cardiopulmonary bypass machine (CPB pump or heart-lung machine).   "
214059|NCT00653055|"     To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus     Dostinex (reference)   "
214060|NCT00653068|"     This phase III trial is studying giving combination chemotherapy together with 3-dimensional     conformal radiation therapy and an autologous peripheral blood stem cell transplant to see     how well it works in treating young patients with atypical teratoid/rhabdoid tumor of the     central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood     stem cell transplant stops the growth of cancer cells by stopping them from dividing or     killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from     the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation     therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells     are then returned to the patient to replace the blood-forming cells that were destroyed by     the chemotherapy or radiation therapy.   "
214061|NCT00653081|"     The purpose of this study is to compare Supervised Exercises with another non-operative     frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with     subacromial impingement syndrome.   "
214062|NCT00653094|"     Today, there is no available equipment specifically designed for the procedure of     instillation of fibrin glue for the repair of perianal fistulae. The currently used equipment     involves surgical tools generally used for fistula surgeries, and injection syringes designed     for general use. The injection of biological adhesives is performed using standard adhesive     syringes that are not specially designed for use in perianal fistulae. The use of the     semi-flexible metal probes can cause trauma to tissue and injure the fistula tract, creating     an additional path, and the injection syringe and catheter are often inconvenient for     perianal use. This study was design to test the use of Halevy kit, by gastroenterology     specialist, as a non traumatic probing, mechanical debridement and injecting or inserting     device for treatment substances in perianal fistulas. In this study a gastroenterologist will     perform the procedure, in each procedure a trained colorectal surgeon will be present during     the surgery to oversee the procedure and to provide surgical help if required.   "
214063|NCT00653107|"     We wish to improve the swallowing function of patients with advanced cancer of the     oesophagus, by carrying out a randomised clinical study in which we compare primary stenting     followed by brachytherapy in the stent, 8 G x 3 with standard brachytherapy 8 Gy x 3.      The aim of the study is to investigate whether patients who receive a stent followed by     brachytherapy have a better swallowing function without more pain at week +2,compared to     patients who receive brachytherapy alone.   "
214064|NCT00653120|"     To compare the single-dose bioavailability of Propranolol 160 Mg ER capsules with Inderal-La   "
214065|NCT00653133|"     This two tiered study is a multi-center, open label, surveillance study of the use of     continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound     guided continuous nerve block techniques. This study was developed to investigate specific     aspects of complication rates related to continuous nerve block techniques in patients     undergoing orthopedic surgical procedures.   "
214066|NCT00653146|"     RATIONALE: Mindfulness-based stress reduction (MBSR) may reduce patient stress and improve     quality of life. It is not yet known whether mindfulness-based stress reduction is effective     in improving immune response to human papillomavirus in patients with cervical dysplasia.      PURPOSE: This randomized clinical trial is studying whether mindfulness-based stress     reduction (MBSR) or a general diet and physical activity program has any effects on immune     response to human papillomavirus in patients with cervical dysplasia.   "
214067|NCT00653159|"     This is a pilot study to determine the feasibility for a randomized controlled trial of two     forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the     Copper T 380A.   "
214068|NCT00654394|"     The purpose of this study is to examine the changes in the carotid artery when subjects     receive high or low doses of rosuvastatin.   "
214069|NCT00654407|"     The purpose of this study is to determine whether treatment with rosuvastatin following     atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk     of Coronary heart disease compared to atorvastatin and simvastatin alone.   "
214144|NCT00655382|"     The purpose of this study is to assess the effects of the Stapled Trans Anal Rectal Resection     (STARR) procedure for patients with obstructive defecation syndrome. This involves a dynamic     pelvic MRI and obstructive defecation score (ODS) at 6 month post STARR procedure.   "
247883|NCT01101841|"     To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for     treatment of vasomotor symptoms (VMS) associated with menopause   "
214070|NCT00654420|"     This is a Phase I/IIa study to evaluate safety and efficacy of dalotuzumab (MK-0646) in     combination with erlotinib in participants with recurrent Non-Small Cell Lung Cancer (NSCLC).     The Phase I part of this study will determine the highest tolerated dose of dalotuzumab to be     given in combination with erlotinib. The primary hypothesis for the Phase I part of the study     is that administration of erlotinib in combination with dalotuzumab in participants with     recurrent NSCLC is generally well-tolerated as evidenced by accumulated safety data from this     trial. The Phase II part of this study will investigate how well dalotuzumab works in     conjunction with erlotinib at treating recurrent NSCLC. The primary hypothesis for the Phase     II part of this study is that administration of erlotinib in combination with dalotuzumab in     participants with recurrent NSCLC results in improvement in Progression Free Survival (PFS)     compared to participants treated with erlotinib alone. PFS is defined as the time from     randomization until either the emergence of radiographic evidence of disease progression (as     documented by an independent core laboratory) or death due to any cause, whichever occurs     first.   "
214071|NCT00654433|"     Eligible research subjects will receive an unrelated umbilical cord blood transfusion as a     possible cure for their inherited metabolic disease. A portion of cord blood cells (ALD-101)     will be separated from the cord blood unit and given approximately 4 hours after the standard     cord blood transfusion.      The study will test if the supplemental cells will increase the speed at which normal levels     of circulating blood cells are re-established after transplant.   "
214072|NCT00654446|"     The purpose of this study is to assess the effects on the kidney of rosuvastatin and     simvastatin in subjects with Fredrickson Type IIa & Type IIb Dyslipidaemia   "
214073|NCT00654459|"     Some nutraceuticals are often advised for their lipid lowering effects. Although many     clinical trials have been conducted to assess their efficacy many doubts remain whether they     could be considered an effective alternative to statins therapy.      The aim of this study was to evaluate the lipid lowering effects and the improvement of     endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product     (Armolipid Plus)   "
214074|NCT00654472|"     To compare mitral valve area in rheumatic mitral valve stenosis with cardiac magnetic     resonance imaging and conventional transthoracic echocardiography.   "
214075|NCT00654485|"     The purpose of this study is to compare the efficacy of treatment with rosuvastatin with     atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in     subjects with metabolic syndrome.   "
214076|NCT00654498|"     To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared     to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)   "
214077|NCT00654511|"     The primary purpose of this study is:        1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and          post-operative analgesia.        2. To determine an analgesic dose response relationship for dexmedetomidine.        3. Compare recovery characteristics of dexmedetomidine to fentanyl.   "
214078|NCT00654524|"     The purpose of this study is to identify the recurrent rate and pregnancy rate of advanced     endometriosis after laparoscopic surgery plus GnRHa goserelin acetate treatment.   "
214079|NCT00654537|"     To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin &     simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with     hypercholesterolaemia.   "
214080|NCT00654550|"     Phase 1 randomized, prospective, double-masked, vehicle-controlled, dose-escalation study to     evaluate the safety, tolerability and clinical effect of Nexagon™ in subjects following     bilateral PRK for the correction of mild to moderate myopia.   "
214081|NCT00654563|"     The study is designed to collect data regarding the clinical course and outcome of patients     suffering from memory disorders. Visits are charged to the individual's insurance inclusive     of Medicare. Patients benefit from expert evaluation and treatment recommendations.     Participants may be eligible for participation in experimental treatments in the future.   "
214082|NCT00654576|"     Antipsychotic alone is limit to improve the overall outcome of schizophrenia and has a high     discontinue rate.To solve these problems, we provide practical and available psychosocial     intervention. We hypothesize that there will be significant difference in the overall     effectiveness between antipsychotic and antipsychotic combination with psychosocial     intervention.   "
214083|NCT00654589|"     The purpose of this study is to investigate the effects of iron chelation using deferasirox     in patients who show signs of iron overload after an allogeneic stem cell transplantation The     iron overload must be due to blood transfusions.   "
214084|NCT00654602|"     The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing     low density lipoprotein cholesterol levels to internationally recognised goals in subjects     with dyslipidaemia.   "
214085|NCT00654615|"     Wrist fractures are the most common type of fractures that occur in the shoulder, arm, and     hand. Approximately 250,000 to 300,000 wrist fractures occur in the United States each year.     Although some wrist fractures can be treated using casts, many other fractures must be     treated with surgery. The surgery involves using metal plates and screws to put the broken     pieces of bone together so that they can heal. The purpose of this study is to compare two     specific types of surgery that are used to treat broken wrists. One type uses pieces of metal     that are placed on the outside of the broken pieces of bone that are screwed in place while     the broken bones heal. The other type of surgery involves placing a piece of metal inside the     bone marrow to hold the broken pieces of bone together as they heal. Individuals with broken     wrists who participate in this study will be randomly assigned to receive one of the two     types of surgical treatment. Both surgical treatments are approved and are not experimental.     Study participants will be followed closely after surgery to determine the time required for     them to return to their usual daily activities involving the use of their arms and hands.     Although both groups of study participants are expected to experience the same outcomes at     one year, those participants that receive the device placed inside the bone marrow may return     to their normal functional activities earlier than the ones treated with the plate placed on     the outside of the bone. Study participants and their surgeons will complete data sheets and     questionnaires that will document their progress following treatment of their wrist     fractures.   "
214086|NCT00654628|"     The purpose of this study is to determine the safety and tolerability of     ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.   "
214089|NCT00654667|"     Sirtuin activators may prove useful in treating age-related diseases and extending lifespan     in humans. Resveratrol (RSV), a polyphenol found in red wine, has been shown in vitro to     enhance SIRT1 activity. RSV is associated with some of the beneficial effects of red wine or     the French Paradox. Recently RSV has been associated with increasing lifespan in mice on a     high calorie diet and improved metabolic profile and activity levels. The effect of this     small molecule in humans is unknown. Preclinical observations suggest that RSV is safe and     has enormous potential in the treatment of obesity and insulin resistance in humans. This     pilot study will examine the effect of RSV on improving the metabolic profile of adults with     insulin resistance. Specifically, this randomized double blind placebo controlled study will     examine the effects of 4 weeks of supplementation with RSV 5.0 grams daily, compared to     placebo control (PC) on the metabolic profile of 36 men and women over the age of 50 with     insulin resistance (IR) consuming a typical western diet consisting of at least 40% calories     from fat.   "
214090|NCT00654680|"     Investigate efficacy and safety of Vardenafil in patients with spinal cord injury   "
214091|NCT00654693|"     -  Determine the accuracy of the NTX wireless monitoring system alerts        -  Evaluate patient compliance with wearing device        -  Determine false alarm rates   "
214092|NCT00654706|"     The objective of this study is to explore the neurocognitive efficacy of Sertindole versus     comparator in patients with schizophrenia using the MCCB.   "
214093|NCT00654719|"     The purpose of this study was to determine the effects of a high caloric drink on weight and     several other clinical markers including quality of life in patients with unintentional     weight loss (cachexia) due to chronic heart failure.   "
214094|NCT00654732|"     The goal of this clinical research study is to compare the effectiveness of receiving     Adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD)     therapy alone to receiving ABVD with rituximab.   "
214095|NCT00654745|"     To determine if olmesartan plus amlodipine combination therapy alone and with     hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive,     type 2 diabetic subjects.   "
214096|NCT00654758|"     The primary purpose of this study is to examine the safety of volociximab in combination with     a standard treatment of carboplatin and paclitaxel in subjects previously untreated with     chemotherapy for advanced stage (IIIB/IV) non-small cell lung cancer (NSCLC).   "
214097|NCT00654771|"     The purpose of this prospective study was to examine whether protein/creatinine ratios in     catheterized urine specimens correlate to clean catch specimens in pregnant patients being     evaluated for preeclampsia.   "
214098|NCT00654784|"     Idebenone is a synthetic analogue of coenzyme Q10 and is a powerful antioxidant and essential     constituent of the process of energy production on the cellular level. It can protect     mitochondria from oxidative damage and boost their impaired function. It is thought that this     mechanism will slow decline in heart function that is part of the disease process of Duchenne     Muscular Dystrophy (DMD). It is possible that patients may benefit in terms of muscle     strength and respiratory function. This pilot trial is designed to investigate this.   "
214099|NCT00654797|"     The Purpose of this study is to:        1. Introduce the refined, validated, and safe computerized bedside decision support tool          for blood glucose management in critically ill adult and pediatric ICU patients that was          studied in Phase 1 into a second group of naïve ICUs, none of which participated in          eProtocol-insulin development, refinement or validation        2. Monitor how often low blood sugar levels occur during use of the bedside tool.        3. Determine how the computerized tool effects the workload of the ICU nurses.   "
214100|NCT00654810|"     The purpose of this study is to examine the effect of age and the effect of exercise     intensity of rehabilitation programs on claudication pain symptoms and leg circulation of     younger and older patients with intermittent claudication.   "
214101|NCT00654823|"     We propose to develop a personalized pharmacogenetic approach including the major genetic     markers of warfarin (coumadin) dosing and patients' age and weight. The known genetic     determinants include several functional and common polymorphisms in CYP2C9 and VKORC1 genes,     which explain the low-end of warfarin dosing range and mostly occur in patients of Caucasian     and Chinese origins. We identified a new VKORC1 polymorphism that is specifically indicative     of the high dose requirements and is dominant over the dose-reducing effect of the known     CYP2C9 and VKORC1 markers. This marker is significantly over-represented in Jews of Ethiopian     origin, but is also common in Ashkenazis, it is also linked to the VKORC1 genetic markers     characteristic of the Afro-American population (published in Blood 2007, 109:2477-80). This     information prompts the development of a more inclusive and universal diagnostic approach to     the individualized warfarin therapy.      The present study aims at evaluation of our novel pharmacogenetic model for predicting     warfarin (coumadin) dose response on the basis of patient's genetic markers of warfarin     sensitivity and resistance, and other patient specific factors. To this end, we proposes to     re-evaluate our previously developed pharmacogenetic model in stabilized warfarin treated     patients (N=200) and then to implement it in a prospective study of patients new on warfarin     as compared to the traditionally treated patients (N=500).   "
214172|NCT00655746|"     The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of     dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of     dasatinib before and after 5 days of dosing with omeprazole in healthy subjects   "
214102|NCT00654836|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry cancer-killing     substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood     flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel together     with bevacizumab works in treating patients with locally recurrent or metastatic breast     cancer.   "
214130|NCT00655200|"     This study is conducted in Asia. The aim of this observational study is to evaluate the     safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino     patients with Type 1 and Type 2 Diabetes Mellitus.   "
214103|NCT00654849|"     Objective: To compare the safety and efficacy of the use of bipolar plasmakinetic vessel     sealing (Gyrus Pk) usage versus standard technique when performing total abdominal     hysterectomy for benign disease.      Material and Methods: controlled randomized trial involving 94 women who underwent total     abdominal hysterectomy. 47 procedures were performed using bipolar plasmakinetic vessel     sealing and the remaining 47 with the standard sutures technique. The primary outcomes were     improvement in terms of blood loss, procedure time, length of hospital stay, and overall cost     of the procedure. Statistical methodology considered significant P <0.05.   "
214104|NCT00654862|"     Intake of cocoa-containing foods has been found to lower blood pressure (BP) in several     clinical trials. It is supposed that the cocoa polyphenols represent the active principle,     lowering BP by increasing the formation of vasodilative nitric oxide. However, direct     evidence for this assumption from controlled clinical studies is lacking. Moreover, in     hypertensive subjects vascular dilation appears to be impaired due to endothelial dysfunction     and vascular smooth muscle remodeling, but it is unclear whether the BP response to cocoa     phenols differs between subjects with high blood pressure and optimal blood pressure.      The investigators hypothesized that (1) intake of cocoa phenols cause a dose-dependent, acute     elevation of circulating bioactive NO levels and a reduction in BP, and that (2) the NO     elevation and BP reduction are impaired in patients with hypertension.      To test this hypothesis, the investigators will conduct a prospective, randomized,     placebo-controlled, double-blind, sample size-calculated, three-period crossover study with     pre-planned statistical analysis and trial monitoring, in which cocoa phenols will be orally     administered to subjects with mild essential hypertension or subjects with optimal blood     pressure. The effects on blood pressure, heart rate, arterial function and plasma levels of     cocoa phenols, circulating bioactive nitric oxide, and plasma markers of oxidative stress     will be evaluated. After a 7-day cocoa-free run-in period and a 12-hour overnight fast, 48     subjects (24 with hypertension and 24 sex-, and age (+/- 2yrs)-matched subjects with optimal     blood pressure) will receive either a single dose of 1000 mg cocoa polyphenols, 250 mg cocoa     phenols or placebo (in capsules of equal form and weight). Each intervention will be followed     by a 7-day cocoa-free washout period before cross-over to the subsequent intervention.     Subjects will be allocated to the intervention sequence by permuted block randomization (i.e.     permuted blocks of 2 subjects with high BP and 2 subjects with optimal BP each, are assigned     to permutations of the tree interventions). Measurements of hemodynamic and plasma parameters     will be performed directly before and 30, 60, 90, 120, 180, 300, and 480 min after capsule     administration. Included subjects will be counseled to maintain their usual diet and physical     activity and to abstain from all cocoa products during the study. Analysis of the data will     be performed on an intention-to-treat basis.   "
214105|NCT00654875|"     This study will compare the safety and efficacy of once daily dosing of aliskiren to twice     daily dosing of aliskiren in patients with moderate hypertension   "
214106|NCT00654888|"     To relieve pain in patients with symptomatic bullous keratopathy (BK) until keratoplasty and     in patients without visual prediction.      The automated lamellar keratectomy represents a alternative in treatment of pain in     symptomatic patients with BK.   "
214107|NCT00654901|"     This is a follow-up of Study A3L11 (NCT00404651).      Immunogenicity        -  To describe the antibody persistence following a primary series vaccination of either          DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.        -  To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of          subjects.      Safety      - To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.   "
214108|NCT00654914|"     The primary objective of this study is to assess the efficacy together with safety of a     flexible regimen, for a period of twelve weeks, of three doses (5 mg, 10mg and 20mg) of Bay     38-9456, a phosphodiesterase type V inhibitor, in males with erectile dysfunction treated     with sildenafil in the previous <6 months .At entry, once the Inclusion and Exclusion     criteria are confirmed, the study medication will be administered for twelve weeks in an open     label design. Vardenafil will be administered, as needed, at a fix dose of 10 mg once daily     for the first four weeks of treatment. At the Investigators' discretion, on the basis of     efficacy and safety evaluations, the patients may, then, receive the same dose strength of     their assigned study medication or, at the subsequent clinic visit(s), the next lower dose (5     mg vardenafil) or the next higher dose (20 mg vardenafil) for the subsequent four weeks of     treatment. Previous dose level of vardenafil is either maintained, increased or decreased by     one step according to the three applicable dose strengths (5 mg, 10 mg, 20 mg ). The highest     dosage of vardenafil (20 mg) per day will not be exceeded. After twelve weeks of treatment,     the patient will be contacted twenty four hours following the last visit in order to collect     data concerning serious adverse events.   "
214109|NCT00654927|"     The purpose of this study is to evaluate the long-term safety, tolerability and activity of     Fampridine-SR in subjects with multiple sclerosis who have previously participated in either     an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible     regardless of whether they received active drug or placebo during their participation in the     previous study.   "
214110|NCT00654940|"     The purpose of this study is to assess whether a cross-over type study design in     post-traumatic neuropathic patients can be used to assess the activity of potential analgesic     agents   "
214111|NCT00654953|"     To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in     combination with gabapentin. The purpose of this study is to examine whether the     antidepressant sertraline alone or combined with gabapentin delays time to relapse relative     to placebo in recently abstinent cocaine-dependent volunteers who are also depressed. In     addition, whether depressive symptoms or genetic factors influence treatment response to the     study medications will be examined. Our hypothesis is that those on combined     sertraline-gabapentin will show a longer period of abstinence than those on sertraline alone     or placebo.   "
214145|NCT00655395|"     -  The purpose of the Phase I portion of this study is to evaluate the safety of this          combination of medications and to determine the appropriate dose of VNP40101M to be used          in combination with infusional cytarabine (araC) in elderly patients with Acute Myeloid          Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS).        -  The purpose of the Phase II portion of the study is to evaluate the effectiveness          (overall response rate) for patients treated with VNP40101M and infusional cytarabine          induction therapy.   "
214126|NCT00655148|"     The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial     investigating the immunogenicity and safety of two DTaP-IPV combination vaccines:      A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line     (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney     cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5,     and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection     in the opposite thigh.      Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for     antibodies against diphtheria, tetanus, pertussis, polio and prp.   "
217160|NCT00696709|"     The purpose of the study is to see if an investigational vaccine for shingles is safe and     well tolerated and brings about an acceptable antibody response.   "
214112|NCT00654966|"     Urotensin II (U-II) is newly discovered protein that may play an important role in human     health and disease. U-II has been found to be a potent vasoconstrictor (narrower of blood     vessels) which therefore may be involved in important diseases such as chronic heart failure     - CHF (weak heart muscle disease). Many vasoconstrictors have been found to have effects on     key organs such as the heart. Preliminary data by our group have demonstrated this is true of     U-II. Recent evidence shows that in CHF, U-II levels in the blood are increased.      The proposed study seek to determine the effect of blocking a possible downstream mediator of     U-II on blood vessels by administration of soluble epoxide hydrolase inhibitor (sEHI). There     will be 2 study groups 1) Healthy volunteers and, 2) CHF patients.      Each arm of the study will run independently and will require 16 participants each (16 normal     subjects and 16 CHF subjects). Participants will be screened to ensure that they are     eligible. CHF patients will be required to withdraw from their CHF medication 24 hours prior     to the study day (except for diuretics). On the study day, sEHI will be administered on the     skin of participants in 3 asceding dosages. The technique to be used is iontophoresis. This     is a non invasive technique in which a small amount of the compound is placed on the skin of     the forearm. The drug is delivered across the skin by passing a small electric current over     the area. The change in blood flow is then measured and analysed. We will also administer     U-II agonist, noradrenaline, and distilled water (all via iontophoresis). Noradrenaline will     be used a positive constrictor control. Change in blood flow will be assessed by Laser     Doppler Velocimetry.      If it is found that the sEHI is able to prevent blood vessel constriction in CHF patients,     then it may represent a major therapeutic advance in the management of CHF.   "
214113|NCT00654979|"     To determine the safety and effectiveness of the SafeFlo filter for permanent protection     against pulmonary emboli. All patients will be selected to receive the filter according to     the stated inclusion / exclusion criteria after consultation between the attending physician     and interventional radiologist. Patients with a permanent implantation will be followed for     up to 6 months. Clinical success will be defined as no occurrences of any of the following     events: recurrent pulmonary embolism, IVC occlusion or filter embolization. The proportion of     permanent filter patients considered to be a clinical success will be the primary efficacy     parameter.   "
214114|NCT00654992|"     The purpose of this study is to determine whether erythropoietin is effective in preventing     acute kidney dysfunction after coronary artery bypass grafting surgery.   "
214115|NCT00655005|"     RATIONALE: Collecting information by questionnaire about the quality of life of patients with     head and neck cancer may help doctors learn more about the disease.      PURPOSE: This clinical trial is testing a questionnaire for assessing pain control, head and     neck symptoms, and general symptoms of illness, demographics, moods, alcohol and tobacco     history, and quality of life related to cancer in patients with newly diagnosed head and neck     cancer.   "
214116|NCT00655018|"     No proven treatment exists for nonalcoholic fatty liver disease (NAFLD) in children and     adolescents. We aim to determine the efficacy of lifestyle intervention with or without     antioxidant therapy in pediatric NAFLD.   "
214117|NCT00655031|"     Pomegranate has a long history of use in folk medicine. There is vast data on the health     benefits of pomegranate fruit and juice. Multiple studies have established the strong     antioxidative effects of pomegranate polyphenols (primarily the ellagitannin punicalagin) and     their health effects. A vast number of animal and human clinical studies have provided     evidence on effect of pomegranate products on reducing symptoms of common cold, reducing     blood pressure, improving endothelial function, anti-tumor activity, and its     anti-atherosclerotic activity. This study will evaluate the protective effect of a     pomegranate concentrate (POMx) in decreasing the incidence and duration of the common cold     among healthy adults.   "
214118|NCT00655044|"     This study is conducted in Europe. The aim of this observational study is to evaluate the     incidence of serious adverse drug reactions while using Levemir® under normal clinical     practice conditions.   "
214119|NCT00655057|"     This study will examine changes in brain dopamine transporter activity before and after     antidepressant therapy.   "
214120|NCT00655070|"     The purpose of this study is to evaluate whether the use application of low frequency     ultrasound, administered by the Timi3 ultrasound device, increases myocardial blood flow to     the heart, in subjects with reduced myocardial blood flow at rest (hibernating myocardium).     The primary endpoint of the trial is to assess the increase in myocardial blood flow from     baseline to post Timi3 Ultrasound treatment in a hypoperfused region of myocardium. Positron     emission tomography (PET) imaging will be used to noninvasively evaluate cardiac blood flow.     The hypothesis is that ultrasound increases blood flow in hibernating myocardium.   "
214121|NCT00655083|"     The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after     single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral     absorption is evaluated through the drug recovery in urine.   "
214122|NCT00655096|"     This study will allow National Eye Institute (NEI) doctors the opportunity to examine people     with eye disease, whether the diagnosis is known or not, to determine if they are eligible     for other NEI research studies. No treatment is offered in this study.      People of all ages with various eye conditions, including genetic conditions, eye movement     disorders, inflammatory eye diseases, retinal diseases and external eye diseases, may be     eligible for this study.      Participants undergo various tests and procedures to diagnose or evaluate their eye disease.     The procedures may include the following:        -  Personal and family medical history        -  Physical examination and blood tests, including genetic testing.        -  Eye examination with dilation to measure visual acuity and eye pressure and to examine          the front and back parts of the eye.        -  Questionnaire about vision and daily activities.        -  Conjunctival swab or lacrimal bland biopsy, or both: A sample of cells from the eyes is          collected by swabbing the surface of the eye or by surgically removing a small sample of          the surface of the eye or tear gland.        -  Electroretinogram to examine retinal function: The subject sits in the dark with his or          her eyes patched for 30 minutes. The patches are removed, the surface of the eyes is          numbed, and contact lenses that can sense signals from the retina are placed on the          eyes. The subject then watches flashing lights.        -  Fluorescein angiography to examine the blood vessels in the eye: A dye is injected into          a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A          camera takes pictures of the dye as it flows through the blood vessels.        -  Optical coherence tomography to measure retinal thickness: A machine used to examine the          eyes produces cross-sectional pictures of the retina.        -  Microperimetry to test how sensitive different parts of the retina are to changing          levels of light. The subject sits in front of a computer and presses a button when he or          she sees a light on the screen.        -  Oculography to record eye movements: Eye movements are measured by contact lenses or          goggles that the subject wears while watching a series of spots on a computer screen.   "
214123|NCT00655109|"     To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center,     double-masked, randomized, placebo controlled parallel treatment conjunctival allergen     challenge (CAC) study in patients with allergic conjunctivitis   "
214124|NCT00655122|"     The primary objective was to study the clinical benefit with dalteparin sodium in     thromboprophylaxis in primary care medical subjects. The secondary objective was a     pharmacoeconomic evaluation of hromboprophylaxis with dalteparin sodium in primary care     medical subjects.   "
214146|NCT00655408|"     This work aims at establishing the effectiveness of weekly doses of ferrous sulfate     administered by mothers compared with weekly supplements administered directly by healthcare     professionals, to reducing anemia prevalence.   "
214131|NCT00655213|"     In case of sinus node dysfunction, it is often necessary to choose the safer option provided     by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode.      In addition to saving energy, the latter mode allows spontaneous ventricular activation, the     haemodynamic consequences of which are, in most cases, better than those obtained with dual     chamber pacing.      Recent studies as the MOST study suggest also that ventricular desynchronization imposed by     right ventricular apical pacing even when AV synchrony is preserved increases the risk of     atrial fibrillation in patients with SND. Similar results were already given by anterior     studies (PIPAF) which, taking into account the percentage of ventricular pacing, suggested     that AF prevention algorithm in combination with a preserved native conduction are efficient     in reducing AF burden.      However, current practice is to implant a dual chamber pacemaker to prevent the risk of     atrioventricular block (AVB) even if DDDR pacing with a fixed long AV delay was found     inefficient in reducing ventricular pacing and was associated with a high risk of     arrhythmias.      The Symphony 2550 cardiac pacemaker offers pacing modes that automatically switch from AAI(R)     mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder,     irrespective of whether or not these are accompanied by an atrial arrhythmia, returning     spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. These 2     particular modes are called the AAI SafeR and DDD/AMC (R) mode.      The main differences between both modes are that (i) AAI SafeR does not trigger any AV Delay     after a sensed or paced atrial event which allows long PR intervals or even limited     ventricular pauses with no switch to DDD(R), while (ii) DDD/AMC (R) is able to optimize AV     Delay after switching to DDD(R) according to measured spontaneous conduction times and to     provide an acceleration in case of vaso-vagal syndrome. This pacing mode has previously been     assessed in clinical studies.      This study intends to demonstrate that the automatic modes switching significantly reduce the     percentage of ventricular pacing in patients implanted with a spontaneous AV conduction and     reduce the occurrence of atrial arrhythmias, on a mid-term follow-up period, in comparison to     standard DDD pacing with long AVDelay.   "
214132|NCT00655226|"     The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is     effective in the prevention of depression during interferon and ribavirin treatment for     hepatitis C infection.   "
214133|NCT00655239|"     This study will evaluate the effectiveness of intensive computerized cognitive training in     preventing the onset of psychotic disorder and improving adaptive functioning in adolescents     at high risk of schizophrenia.   "
214134|NCT00655252|"     This expanded access study is designed to provide RAD001 to patients with MRCC who are     without satisfactory treatment alternatives, until RAD001 becomes commercially available.   "
214135|NCT00655265|"     This study is designed to assess whether colesevelam given as third line treatment added to a     maximal tolerated and stable dose of a statin and ezetimibe is able to further decrease the     level of LDL cholesterol in a safe and efficient manner in difficult to treat Familial     Hypercholesterolaemia patients who are not at their target level of LDL cholesterol.   "
214136|NCT00655278|"     This study will evaluate the safety and efficacy of T2000 when used to treat patients with     moderate to severe essential tremor over an 18 month period.   "
214137|NCT00655291|"     The purpose of this study is to determine if XP20B is an effective treatment for the relief     of pain following bunionectomy surgery.   "
214138|NCT00655304|"     The main objective of this study is to investigate the effect of Prometheus liver support     dialysis on intracranial pressure, cerebral metabolism and circulation in patients with acute     liver failure.   "
214139|NCT00655317|"     Postoperative ileus, the transient cessation of normal bowel function, is a universal aspect     of colon surgery. Its occurrence may lead to increased patient discomfort and additional time     and cost to hospital stay. Evidence from previous studies indicate that acupuncture may be     beneficial in decreasing time to recovery of bowel function and decrease the body's     inflammatory response. However, this has not been studied in a randomized, prospective     fashion in colon surgery. The goal of this study is to determine if acupuncture may be     utilized as a therapeutic modality to decrease time to return of bowel function and discharge     from the hospital.   "
214140|NCT00655330|"     This is a prospective randomized controlled, open-labeled study to identify the efficacy of     probucol in combination with valsartan in patients with Diabetes nephropathy. The reduction     of urinary albumin or proteinuria will be the primary outcome studied. The expected study     duration will be 48 weeks.   "
214141|NCT00655343|"     The study aim is to evaluate the influence of the anti-T-lymphocyte globulin ATG-Fresenius S     given pre-transplant in addition to standard GvHD prophylaxis with cyclosporine A and a short     course of methotrexate with respect to efficacy and safety.   "
214142|NCT00655356|"     The purpose of this study is to evaluate the safety profile and the treatment effect of     Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold     wrinkles.   "
214143|NCT00655369|"     In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive     treatment effect relative to placebo on the primary endpoint, the weekly version of the     Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of     varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be     explored in Nonrestorative Sleep subjects.   "
214148|NCT00655434|"     This study is designed to compare the performance of the Focus Diagnostics' HerpeSelect®     Express, a Herpes Simplex Virus 2 Rapid Test, to a currently marketed device. The intent is     to show the rapid test device is comparable to the currently marketed device. HerpeSelect®     Express is a rapid test intended for qualitatively detecting the presence or absence of human     IgG class antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (capillary).   "
214149|NCT00655447|"     At the time of hysterectomy for benign disease, the overall health benefits of preserving     ovarian function in a large population of women have not been established.   "
214150|NCT00655460|"     The Purpose of this study is to:        1. Refine and validate a computerized bedside decision support tool blood glucose          management in critically ill adult and pediatric ICU patients.        2. Monitor how often low blood sugar levels occur during use of the bedside tool.        3. Determine how the computerized tool effects the workload of the ICU nurses.   "
214151|NCT00655473|"     This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic     plaque in patients with coronary heart disease (CHD) including patients with other CHD risk     factors. After a pre-randomisation period during which positron emission tomography computed     tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either     RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at     intervals during the study. The anticipated time on study treatment is 2 years, and the     target sample size is 100 individuals.   "
214152|NCT00655486|"     The purpose of this study is to allow eligible subjects from the parent study, SP925     [NCT00655551] to continue lacosamide and to obtain additional long-term safety data   "
217161|NCT00696722|"     The purpose of this study is to determine whether atazanavir use is of influence on the     endothelial dysfunction associated with type 2 diabetes mellitus.   "
214153|NCT00655499|"     RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     irinotecan, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving panitumumab together with irinotecan may kill     more tumor cells.      PURPOSE: This phase II clinical trial is studying giving panitumumab together with irinotecan     to see how well it works as third-line therapy in treating patients with metastatic     colorectal cancer.   "
214154|NCT00655512|"     to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1%     cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream   "
214155|NCT00655525|"     The overall goal of this study is to examine the role of fish oil supplementation in     ameliorating the inflammatory state of uremia and the related muscle protein catabolism     associated with this disease state. We hypothesize that if administered for a period of 3     months, fish oil will improve the chronic uremic inflammation. We further hypothesize that     fish oil administration will improve the muscle protein breakdown associated with uremia and     inflammation.   "
214156|NCT00655538|"     This study will assess the safety, tolerability and efficacy of RO4607381 in patients with     coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive     either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by     flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time     on study treatment is up to 12 months, and the target sample size is up to 500 individuals.   "
214157|NCT00655551|"     The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered     in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with     partial-onset seizures.   "
214158|NCT00655564|"     The purpose of this research study is to see how well the medication Alefacept (Amevive®)     works for continuous treatment of chronic plaque psoriasis. The US Food and Drug     Administration (FDA) has approved Alefacept in an intermittent dosage schedule of 15 mg     weekly injection for 12 weeks followed by 12 weeks off treatment.   "
214159|NCT00655577|"     The significance of this population-based study is in producing new information for planning     interventions and rehabilitation programs for the elderly, planning education of health care     personnel and planning national health education programs for different age groups.      The study consists of an epidemiological cross-sectional study and a randomized controlled     intervention study. The study population consisted of all the 1689 home-dwelling women born     during 1924-1927 residing in Oulu, Northern Finland, who were asked to a screening visit     including bone mineral density (BMD) measurement of the distal radius in 1997. 1222 women     attended the clinic and were afterwards mailed a postal questionnaire focusing on lifelong     risk factors for osteoporosis, e.g. the amount of physical activity at work and during     leisure time, daily intake of calcium and use of alcohol and cigarettes. Those with BMD value     more than 20% lower than the reference value, underwent a densitometry of the hip. All women     with femoral neck BMD more than 20% below the reference value (n=160) were randomly selected     to either exercise (n=84) or control (n=76) group. At baseline and after that annually during     the 30-month intervention, balance, muscle strength, aerobic capacity, walking speed,     cognitive functions and mood are measured from all the participants. Hip BMD will be measured     annually. The exercise group participates in a supervised training program with weekly     sessions from the beginning of October to the end of April. In addition to the supervised     sessions the participants train daily at home. From April to October the exercises are     performed purely at home. The training regimen consists of balance, strength and impact     exercises. The intervention group keeps diary of their daily physical activity. The number     and severity of falls are recorded from both the groups.      The purpose of the study is:        1. to identify factors accounting for low BMD in elderly home-dwelling women with severe          osteopenia.        2. to evaluate how supervised regular weight-bearing exercise program affects BMD in          elderly home-dwelling women with severe osteopenia        3. to evaluate how supervised regular balance and muscle training affects balance and          muscle strength in elderly home-dwelling women with severe osteopenia.           In addition the aim is to:        4. study how regular supervised exercise affects the incidence and severity of falls, mood          and cognitive functions in women with severe osteopenia.      Hypothesis and research methods      The main hypothesis is that long-term supervised, mainly home- based regular impact-type and     balance and muscle exercises can improve balance and muscle strength of lower extremities and     maintain bone mass in elderly women. We also hypothesize that the incidence of falls is lower     in the exercise group than in the controls and that the falls are more injurious in the     control group than in the intervention group during the follow-up period   "
214160|NCT00655590|"     Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on     sperm function   "
214173|NCT00655772|"     A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.   "
214174|NCT00655785|"     The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402     restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination     with gemcitabine   "
214215|NCT00656318|"     Thus, the proposed study has the following Specific Aims and Hypotheses:        1. To determine in menstruating women ages 18-45 whether an OCP containing ethinyl          estradiol (EE) and the progestin ethinydiol diacetate (ED) increases cortical GABA          concentrations as measured using proton magnetic resonance spectroscopy (1H-MRS) above          that of an OCP containing EE and the progestin norethindrone (NOR).        2. To determine the relationship between changes in occipital GABA concentrations with          acute OCP administration and negative affect with chronic OCP administration over two          menstrual cycles.   "
214161|NCT00655603|"     Incretinbased treatment of patients with type 2 diabetes mellitus (T2DM) has increasing     interest. The incretin glucagon-like peptide-1 (GLP-1) stimulates beta-cells to increased     secretion and production of insulin. Glucose sensitivity is enhanced, apoptosis inhibited -     progression in disease is potentially stopped. The alpha-cell is also influenced by GLP-1 as     infusion lowers plasmaglucose (PG) levels in patients with type 1 diabetes mellitus (T1DM)     (C-peptide negative) by inhibition of glucagon and thereby decreased hepatic     glucoseproduction (HGP). Further Vilsboll et al has proved normalization of the     glacgonostatic effect of glucose in patients with T2DM. As an attempt to elucidate     glucose-intolerance in patients with T2DM further Knop et al investigated the     glucagonresponse to both oral glucose tolerance test (OGTT) and a following iso-glycemic     clamp. He saw a sufficient suppression of glucagon when glucose was introduced intravenously     but the suppression of glucagon was attenuated and delayed when glucose was given orally.      The aim of this study is to elucidate the glucose intolerance further. Due to the complex     interactions and mutual feed-back regulation between the pancreatic hormones and the PG level     this protocol includes five days. All days include a euglycemic-clamp, patients with T2DM     (n=10) are clamped at their fasting PG as are healthy control subjects (n=10). During the     clamp either GLP-1 alone; GLP-1 in combination with somatostatin, insulin and glucagon; or     somatostatin, insulin and glucagon are infused and blood samples are drawn.      The design of the study makes it possible to isolate the effect of each hormone. Further the     investigators will be able to enlighten the effect of GLP-1 on the increase in glucose     turn-over it induces.      The essential part in this design will be hormone concentrations and the response parameter     the amount of glucose (AUC) it takes to create the euglycemic-clamp.   "
214162|NCT00655616|"     The purpose of this study is to determine whether patients with asthma who carry a genotype     associated with adverse outcomes with long-acting beta-2 agonists like salmeterol show     greater benefit from the use of an asthma drug that works via alternative pathways like     montelukast.   "
214178|NCT00655837|"     The purpose of this study is to determine safety and tolerability of combination therapy of     SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also     intended to estimate how well your disease responds to this treatment.   "
214163|NCT00655629|"     This study investigates the safety and efficacy of a new dosage form of Vardenafil, an     orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo     (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase,     patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be     determined by laboratory and other evaluations. Efficacy will be determined by the results of     different questionnaires and the patient diary that will be used.   "
214164|NCT00655642|"     The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and     promethazine for the treatment of nausea in the adult emergency department population.      We hypothesize that a single intravenous dose of ondansetron is more effective in reducing     nausea than a single IV dose of metoclopramide, promethazine or normal saline placebo in     undifferentiated adult emergency department patients.   "
214165|NCT00655655|"     RATIONALE: Everolimus and vatalanib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving everolimus     together with vatalanib may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus and     vatalanib in treating patients with advanced solid tumors.   "
214166|NCT00655668|"     This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide     monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study     will be conducted in two phases: a Treatment Phase and a Follow-up Phase.      Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive     single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles).     Subjects may continue participation in the Treatment Phase of the study for a maximum     duration of 24 months, or until disease progression or unacceptable adverse events develop.      All subjects who discontinue the Treatment Phase for any reason will continue to be followed     until progression of disease or until next lymphoma treatment is given, whichever comes     first, during the Follow-up Phase.      Objectives:      Primary:      • To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell     Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor     control rate, duration of response, time to progression and progression free survival.      Secondary:      • To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed     or refractory T-cell NHL.   "
214167|NCT00655681|"     Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk     for low bone density      Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre     operatively and studied with DXA scan. After surgery, children will be randomized to receive     either pamidronate or saline. Repeat DXA scan will determine bone lost after end of     immobilization or nonweightbearing.   "
214168|NCT00655694|"     Chronic obstructive pulmonary disease (COPD) is a chronic disease characterized by     progressive airflow obstruction, chronic cough and dyspnoea in advanced stages.      Techniques such as genomics, proteomics and metabonomics, Technologies that aim to identify     and quantify the dynamic set of all small molecules and metabolites present in an organism or     a biological sample, offer the prospect of efficiently distinguishing individuals with     particular diseases. The advantages of proteomics and metabonomics is that it can be carried     out on a standard preparation of serum, plasma or urine, circumventing the need for     specialist preparation of cellular mRNA required for genomics This methodology is based on     mass spectrometry (MS), gas chromatography-mass spectrometry (GC-MS), and nuclear magnetic     resonance (NMR) to analyze metabolites. High-performance liquid chromatography (HPLC) may     also be applied. Several peak alignment algorithms have been developed to match the     chromatograms before applying pattern recognition. Based on the pattern recognition, several     potential biomarkers may be found and further identified by MS.. Finally, a number of     potential biomarkers will be identified for distinguishing asthma and COPD.      We hope to develop a better understanding of lung disease. Information from these studies     will only be used for research purposes, to help develop safer and more effective treatments     for asthma and COPD.   "
214169|NCT00655707|"     This is a prospective dose escalation study of the administration of adult human stem cells     in patients with end stage liver failure. Successive groups of two patients will receive     ascending doses of autologous adult human stem cells starting at 1x10[9] cells. Following     expansion in an approved GMP facility the cells will be infused into either the hepatic     artery or portal vein of research participants.      The aim of this trial is to determine the maximum tolerated dose of autologous adult stem     cells when infused into either the hepatic artery or the portal vein. The maximum dose that     would be given would be 5x10 to the ten [10].      To assess improvement in liver function as measured by serological and biochemical analysis     and determine whether there are any symptomatic improvements as reported by the patients.   "
214170|NCT00655720|"     A study to evaluate the growth and development of term infants fed either an extensively     hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an     extensively hydrolyzed formula without probiotics   "
214175|NCT00655798|"     In the present study it is hypothesized that a reduction of the inflammatory status may     prevent the occurrence of disorders and diseases related to overweight.      In this study the effects of nutritional compounds will be studied in overweight men with a     low grade inflammatory status. We will investigate the effects of 3 different food treatments     as compared to a placebo on markers of inflammation and on parameters of glucose and fat     metabolism. The three different food treatments are a food mix and two yogurts each     containing different probiotic strains. The food mix is composed of a mix of nutritional     components, each reported to affect inflammation parameters and (or) anti-oxidant status but     different in their -hypothesized-mode of action.   "
214176|NCT00655811|"     The purpose of this research is to study how people respond differently to capsaicin in     different racial groups and the effect it has on your pain levels. Capsaicin is a natural     product made from hot chili peppers that is useful for treating the itch symptoms of skin     disease.   "
214177|NCT00655824|"     A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and     who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the     trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9     treatment courses) of ofatumumab in RA patients who previously received ofatumumab or placebo     in Trial Hx-CD20-403.   "
214179|NCT00655850|"     This study is being done to determine the overall progression-free survival (PFS) in patients     with advanced or metastatic (Stage IIIB - pleural effusion/IV), non-squamous histology NSCLC     treated with metronomic chemotherapy plus Avastin. Also, currently there are no defined     markers that predict for clinical benefit to Avastin. Preliminary studies show that there are     several observations that support the concept of metronomic chemotherapy with or without the     combination of an anti-angiogenic agent. The metronomic chemotherapy with Avastin was shown     to enhance the clinical endpoints of the study (response rate and progressive-free survival).     Proof of metronomic scheduling requires the development of appropriate intermediate surrogate     markers. Several markers will be assessed.   "
214180|NCT00655863|"     The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by     itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.   "
214181|NCT00655876|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by     blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin     together with radiation therapy is more effective with or without cetuximab in treating     esophageal cancer.      PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and     cisplatin together with radiation therapy works with or without cetuximab in treating     patients with locally advanced esophageal cancer.   "
214182|NCT00655889|"     The purpose of this study is to evaluate the safety profile and the treatment effect of     Isolagen TherapyTM in subjects with maxillary lesions who were treated in a previous study     (IT-G-002)   "
214183|NCT00655902|"     The aim of the present study is to assess the effect of a high intake of industrially     produced trans fatty acids for 16 weeks on abdominal obesity and risk markers of type 2     diabetes and heart disease in healthy, moderately overweight, postmenopausal women.   "
214184|NCT00655915|"     This study will investigate whether symptomatic improvement following carpal tunnel     corticosteroid injection can be correlated to symptomatic improvement following carpal tunnel     release and therefore serve as a prognostic indicator.      Clinical question: Does response to corticosteroid injection in CTS predict outcomes of     surgical treatment?      Secondary Questions:        1. Can we confirm previous retrospectively collected data that a certain percentage of          conservatively managed patients with steroid injection will avoid surgery, and that          patients who undergo surgery will have better outcomes than those who do not.        2. Are there differences between worker's compensation and non-worker's compensation          patients with regard to the primary clinical question?        3. What are Carpal Tunnel Release outcomes for the subset of patients with negative          electrophysiologic studies?        4. What are the outcomes of patients who undergo carpal tunnel release vs. those who choose          not to undergo carpal tunnel release?      A prospective cohort design study is the appropriate study design in order to measure the     association between a predictor (response to injection) and outcome (response to surgery).   "
214185|NCT00655928|"     The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day     pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on     blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.   "
214186|NCT00655941|"     Obesity and osteoarthritis (OA) co-exist in an increasing part of the population.      The two diseases intertwine in several ways. The evolution in the population shows a tendency     towards deterioration of both by increasing general age and weight. The two diseases share     pathogenetic features and the development of one disease increases the risk of the other and     may be the onset of a vicious circle.      There is a link between treatments of these two diseases as well. There is now solid (gold)     evidence that by treating effectively the obesity of patients with co-occurring OA, the     functional status is dramatically ameliorated; the short-term results are equal to that of a     joint replacement. The long-term efficacy of a weight loss remains to be shown. OA is     definitely one of many diseases in which obesity must be taken seriously into account when     planning a correct treatment of patients. This trial has two phases, the first (16 weeks)     consisting of a dietary intervention with low-energy diet and the second (52 weeks) a     randomized, three group (each n>50 patients) controlled study of maintenance of weight loss     by either continuing dietary instruction, exercise, or a control group. The hypothesis is     that maintenance of an initially induced weight loss is dependent on attention rather than     any specific therapy.   "
214187|NCT00655954|"     -  Osteoprotegerin (OPG) is a secreted glycoprotein containing 401 amino acids. It is a          member of the tumour necrosis factor (TNF) receptor superfamily. It was firstly          discovered as a protein regulating bone metabolism, inhibiting osteoclastogenesis,          consequently, inhibiting bone resorption        -  Evaluation of OPG level as disease markers has also been reported. It has been showed          that patients with coronary artery disease had higher serum OPG levels than healthy          volunteers. Moreover, serum OPG levels correlate with the number of stenotic coronary          arteries        -  OPG is detected in lung using Northern blot analysis        -  It is likely that OPG would contribute to the pathogenesis of COPD and could be an          effective disease marker of the disease   "
214202|NCT00656149|"     1. To evaluate improvements in hand function in stable, cervical spinal cord injured (SCI)          subjects treated with functional electrical stimulation (FES)-assisted exercise;        2. To compare the information obtained from existing qualitative and quantitative hand          function tests with newly developed tests of sensorimotor performance.      Hypotheses:        1. the performance of tasks representative of activities of daily living (ADL) will improve          with daily tele-supervised exercise of the affected hand.        2. The improvements will be greater in one exercise protocol than the other, the protocols          being a) FES-assisted exercise on a workstation, b) cyclical FES, weight training and          precision tasks.        3. Scores derived from quantitative data obtained from sensors on the workstation will          correlate with the qualitative scores of the primary outcome measure, the ARAT hand          function test.   "
214188|NCT00655967|"     Alcohol abuse and dependence are very prevalent and result in significant morbidity,     mortality and cost to society (Harwood 2000). Pharmacotherapies to assist with alcohol     dependence consist of disulfiram, naltrexone and acamprosate. Of these, acamprosate is unique     in that it is not metabolized by the liver, but rather completely excreted renally. In     contrast, naltrexone is metabolized by the CYP450 system of the liver and less than 2% is     excreted unchanged and can cause liver damage (PDR 2005). Multiple cases of hepatitis,     including both cholestatic and fulminant hepatitis, as well as hepatic failure resulting in     transplantation or death, have been reported with administration of disulfiram (PDR 2005).     The incidence of liver disease among alcoholics is high and increases with age and years of     drinking and this may preclude the use of antabuse or naltrexone to help alcohol dependent     patients with liver disease or that are elderly . Thus acamprosate has a unique safety     profile that would make it ideally suited for treating alcohol dependence in the elderly,     even in the presence of hepatic impairment. The current study is to evaluate the safety     profile of acamprosate in elderly patients with alcohol dependence.      Acamprosate, calcium acetyl homotaurinate, has been approved in most European countries and     the U.S. for the maintenance of abstinence in recently detoxified alcoholics. The mechanism     of action involves primarily the restoration of a normal N-methyl- D -aspartate (NMDA)     receptor tone in glutamatergic systems (Rammes et al 2001). Several trials of acamprosate     confirm its efficacy in the maintenance of abstinence in alcohol dependence (Lesch et al.     2001; Slattery et al. 2003; Mann et al. 2004; Verheul et al. 2004). It also reduces the     severity of relapse in alcoholics in abstinence based treatment programs (Chick et al. 2003).     There is limited data on the safety of acamprosate in the elderly (PDR 2005).      For the purposes of this study, elderly will be defined as 60 years or older.      STUDY OBJECTIVE: To determine the short-term safety of Acamprosate in the treatment of     alcohol dependence in the elderly.   "
214189|NCT00655980|"     In this study, we want to find out if laughing gas (nitrous oxide) leads to a higher rate of     cardiac complications after surgery in patients with a specific genetic profile (mutations in     the MTHFR gene) and if this risk can be prevented by giving patients vitamin B12 and folate     during surgery.   "
214190|NCT00655993|"     Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in     COPD patients.   "
214191|NCT00656006|"     A Study of Albuferon with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis     C Genotype 2 or 3.   "
214192|NCT00656019|"     This study will assess whether levels of vitamin D impact the characteristics of a woman's     breast cancer at diagnosis, and whether a short course of vitamin D in women with low levels     of vitamin D changes the gene expression of their breast cancers.   "
214193|NCT00656032|"     The broad goal of this study is to understand the mechanisms by which Vitamin D receptor     activation leads to changes in insulin signaling in advanced uremia. We hypothesize that     1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin     resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in     End Stage Renal Disease patients.   "
214194|NCT00656045|"     The purpose of this investigation is to conduct an 8-week pilot study to examine the effects     of two different leisure-time activity prescriptions on dietary intake, leisure-time     activities, and weight loss in 26 adults receiving a standard 8-week behavioral weight loss     intervention.   "
214195|NCT00656058|"     Background:      Bronchiolitis obliterans is a form of chronic graft-versus-host disease (GVHD) that sometimes     develops after stem cell transplantation (SCT) or bone marrow transplantation (BMT).      In bronchiolitis obliterans, immune cells that normally fight infections attack the lungs of     the transplant recipient, causing destruction of lung tissue and fibrosis (scarring). When     fibrosis develops, the lungs cannot work properly.      Montelukast (Singulair) is a drug that has been used for many years to treat asthma. Its use     as a treatment for bronchiolitis obliterans is experimental.      Objectives:      To see if montelukast improves or stabilizes lung function in patients who develop     bronchiolitis obliterans after BMT or SCT.      To assess the safety of montelukast in patients with bronchiolitis obliterans after BMT or     SCT      To see if montelukast affects the cells that damage the lungs.      To see if montelukast improves other forms of chronic GVHD, quality of life, and overall     survival in patients with bronchiolitis obliterans after BMT or SCT.      Eligibility:      Patients 6 years of age and older with bronchiolitis obliterans following stem cell     transplantation.      Design:      Patients take one montelukast tablet daily for 6 months and undergo the following procedures     during this period:        -  Lung function tests. The patient breathes into a machine that measures the amount of air          that goes into and out of the lungs. This test is done once a month for 3 months, then          at 6 months, 12 months and 24 months.        -  Medical history and physical examination at the study site about every 3 months for the          first year of the study and then at 12 months and 24 months. Patients also have physical          examinations monthly for the first 6 months at their primary doctors office. Tests may          include blood and urine tests, chest computed tomography (CT) scans, echocardiogram          (heart ultrasound), 2- and 6-minute walk tests, and quality-of-life questionnaires.        -  Bronchoalveolar lavage in patients 18 years of age and older. The subject s mouth, nose          and airways are numbed with lidocaine. Some patients may need sedation or anesthesia for          the procedure. A tube (bronchoscope) is then passed through the nose into the airway,          and a small amount of fluid is put into the lung. The fluid is then removed and tested          for infections or other lung problems.        -  Apheresis to collect white blood cells. Whole blood is collected through a tube inserted          into a vein in the arm. The white cells are extracted in a cell separator machine, and          the rest of the blood is returned to the body through a tube placed in a vein in the          other arm. The cells are used to study GVHD and bronchiolitis obliterans.        -  Patients who wish to continue montelukast therapy after 6 months may do so under the          care of their primary doctor, if both agree to the continuation....   "
214196|NCT00656071|"     By examining the intraoperative anesthetic characteristics of patients who developed ARDS     postoperatively, we hope to identify variables which have a positive or negative association     on the development of ARDS.   "
214197|NCT00656084|"     To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone,     and Rituxan in relapsed or refractory MCL   "
214198|NCT00656097|"     The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in     combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo     in combination with rabies vaccine in healthy adult subjects.   "
214199|NCT00656110|"     The purpose of this study is to determine whether, in a randomized, placebo-controlled trial,     restless legs syndrome (RLS) can be caused by pinched and damaged foot nerves called     neuromas.   "
214200|NCT00656123|"     RATIONALE: Vaccines made from tumor cells may help the body build an effective immune     response to kill tumor cells. Giving vaccine therapy together with chemotherapy may be a more     effective treatment for colorectal cancer.      PURPOSE: This phase I trial is studying the side effects of vaccine therapy given together     with cyclophosphamide in treating patients who have undergone surgery for liver metastases     due to metastatic colorectal cancer.   "
214214|NCT00656305|"     A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic     Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not     Candidates for Radiation Therapy   "
214201|NCT00656136|"     This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients     with NSCLC who have received previous treatment with at least one but not more than two lines     of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either     gefitinib or erlotinib for a period of at least 12 weeks and then progressed.      The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a     single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population.     Patients on both treatment arms will receive best supportive care in addition to study     treatment.      Patients enrolled into the trial will be treated and followed until death or lost to     follow-up.   "
214203|NCT00656162|"     Fractures of an elbow are common in children. Accurate initial diagnosis is crucial for the     management of the fractures of an elbow. In young children the fractures may be suspected     clinically but missed on x-rays due to mostly non-ossified cartilage that is not visible on a     regular x-ray. We propose that every x-ray negative, but clinically suspicious elbow trauma     in children can be additionally evaluated using high resolution US.   "
214204|NCT00656175|"     Ritonavir-boosted protease inhibitor (PI) regimens have become a backbone for treatment of     people with HIV. However, adverse drug effects, particularly lipodystrophy/lipoatrophy are     closely associated with these regimens. Therefore, there is a need for a drug with comparable     effectiveness to the ritonavir boosted PIs without the side effects of dyslipidemia, which     has been associated with elevated cholesterol and cardiovascular disease      Raltegravir is an HIV integrase inhibitor in phase III clinical development. To date there     are no approved drugs that target the same stage of the HIV-1 lifecycle. However, data from     studies indicate that raltegravir is generally safe and well tolerated and has strong     antiretroviral activity when used in combination with licensed antiretroviral medications.      This study aims to demonstrate that patients substituting raltegravir for a PI or NNRTI based     antiretroviral regimen will be associated with a 10% reduction in body fat over 24 weeks.      The study will consist of a total of 10 subject visits over a period of 48 weeks.     Approximately 40 female patients will participate in this study (approximately 10 at UCLA).   "
214205|NCT00656188|"     This study tested the hypothesis that vardenafil was both clinically effective and     well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.   "
214206|NCT00656201|"     The goal of this research study is to compare the pregnancy rates for two different types of     progesterone supplementation after in-vitro fertilization (IVF).   "
214207|NCT00656214|"     the purpose of this study was to evaluate that if lycopene, a potent antioxidant can be used     in the treatment of oral lichen planus. this could be useful as lycopene has no reported side     effects and hence it can used in place of steroids which are commonly used for this condition     and have many reported adverse effects.      lycopene can be used in the treatment of this condition as free radicals have been found to     play a role in the cause of this disease and also lower levels of lycopene were seen in these     patints.   "
214208|NCT00656227|"     This trial will investigate whether four doses of RN1001 (20ng, 50ng, 100ng and 200ng) are     efficacious in preventing or reducing the resultant scar, as compared to placebo, when     applied intradermally to wound margins following excision of benign naevi situated on the     head and neck.   "
214209|NCT00656240|"     To investigate the intraocular pressure (IOP)-lowering effect and safety of DE-104 ophthalmic     solution in patients with Primary Open-Angle Glaucoma or Ocular Hypertension   "
214210|NCT00656253|"     This study was designed to evaluate the symptomatic effects or potential disease progression     slowing down effect of a kind of Herbal Medicinal Mixture in Parkinson's disease (PD)     patients. The treatment phase includes 12 months period of Herbal Medicinal Mixture per day     or placebo and 1 month wash-out period without herbal medicine and placebo.   "
214211|NCT00656266|"     The objective of this study is to compare the effects of two liver transplant     immunosuppression regimens on renal function. Patients receiving the standard combination of     prednisone and high-dose tacrolimus, a drug with known nephrotoxicity (Arm A) will be     compared to patients receiving prednisone, low-dose tacrolimus and mycophenolate mofetil     (MMF) (Arm B). MMF is an immunosuppression agent that has no associated nephrotoxicity. The     primary end point of the study will be renal function as measured by glomerular filtration     rate (GFR). Thirty pediatric liver transplant recipients will be randomized to these two arms     in a 1:1 ratio (i.e. 15 patients in each group). Secondary end points will measure patient     and graft outcome and incidence of immunosuppression-related complications, including:     neurotoxicity, diabetes mellitus, growth retardation, vomiting, diarrhea, gastrointestinal     hemorrhage, thrombocytopenia, anemia, leukopenia, acute or chronic liver graft rejection,     posttransplant lymphoproliferative disease (PTLD), viral infections, fungal infections and     bacterial infections.   "
214212|NCT00656279|"     A low phosphorus diet is recommended for patients with chronic kidney disease who exhibit     high levels of phosphorus. The purpose of this study is to determine the effects of a more     intensive, innovative dietary phosphorus educational intervention on reducing serum     phosphorus levels, as well as improving dietary adherence, dietary satisfaction and     phosphorus knowledge level in patients with chronic kidney disease.   "
214213|NCT00656292|"     The purpose of the present study is to quantify the degree of modulation, if any, in the     perioperative inflammatory response associated with statins use. Specifically, we hypothesize     that:      In a population of patients undergoing elective orthopedic spine surgery, administration of a     specific statin (Simvastatin, Zocor®, Merck Pharmaceuticals), will be associated with a     decrease in perioperative inflammatory markers when compared to patients not taking statins   "
214216|NCT00656331|"     The purpose of this study is to compare the effects of the cholesterol medication taken with     each blood pressure medication alone on heart disease risk factors including blood pressure,     cholesterol, inflammation, blood sugar control, blood vessal function, and other heart     disease risk factors.   "
214217|NCT00656344|"     This study is exploring the use of an intervention designed to treat PTSD in individuals with     comorbid PTSD and substance abuse resulting from the attacks of September 11 or from military     service in Iraq. A cognitive behavioral treatment protocol will be used to treat PTSD. The     exposure component of the protocol will be enhanced with the use of virtual reality in which     the client will view a virtual environment while describing their trauma.   "
214218|NCT00656357|"     This study will assess the potential interaction and subjective effects between intravenous     cocaine and SYN117 in non-treatment seeking cocaine dependant subjects   "
214219|NCT00656370|"     Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates     of different solutions subcutaneously (SC) infused and preceded by human recombinant     hyaluronidase (hylenex) 150 units.      In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR)     solution. Each subject will receive 500 milliliters (mL) of solution, consisting of NS in one     thigh and LR in the other thigh. Immediately prior to the infusions, each thigh will have 150     units of hylenex.      In Stage 2, the comparison will be NS solution and buffered NS solution.   "
214220|NCT00656383|"     Individuals referred to home care for leg ulcer management were randomized to nurse home     visits (usual care) or nurse-run community clinics (intervention). The primary outcome will     be the time to healing rates at three months. Secondary outcomes are: time to healing of all     ulcers within the 12 month follow-up period, time to first recurrence of a healed ulcer, the     number of weeks patients were free from ulcers, function, pain, and health related quality of     life, client and provider satisfaction. We hypothesize that nurse-run neighborhood clinics     result in better healing rates, more cost-effective care, and improved client and provider     satisfaction than the home visiting model.   "
214221|NCT00656396|"     Bleeding is a frequent complication during surgery. The peri-operative administration of     blood products, including packed red blood cells, thrombocytes and fresh frozen plasma (FFP),     is often deemed necessary. Therefore the transfusion of allogenic blood products mandates     strategies to optimize the clinical decision to transfuse. The decision to administer FFP is     usually made in the absence of any data. Point of care testing of prothrombin time ensures     that a major parameter of coagulation is readily available. The test is fast, easy to     perform, inexpensive and may enable physicians to rationally determine the need for FFP.     Objective of the study is to determine the effectiveness of point of care coagulation testing     of prothrombin time to reduce the administration of FFP.   "
214222|NCT00656409|"     Ataxia Telangiectasia (AT) is an autosomal recessive inherited condition caused by mutations     in the ATM gene1. Patients suffer from neuro-degenerative problems, usually commencing in the     second year of life, and affecting predominantly the cerebellum. They also develop the     characteristic superficial telangiectases. Between 60 and 80% of affected children are     immunodeficient. This is associated with deficiency of immunoglobulin A (IgA ) 2, of IgG23     and of antibody responses to pneumococcal polysaccharides4. Patients suffer recurrent     sino-pulmonary infections but a recent study suggests poor correlation between immune status     and immunological parameters5. If uncontrolled, recurrent pulmonary infections can contribute     to the development of chronic lung disease and bronchiectasis. Preventative management     includes continuous prophylactic antibiotic treatment in some with the need for replacement     immunoglobulin therapy in only a small proportion of cases. Antibiotics have been reasonably     effective in this situation but the emergence of resistance amongst community acquired     pneumococcal isolates is a cause for concern. Appropriate immunisation strategies may also     have a role.      This study is designed to look at antibody responses in a one versus two dose regimen in a     cohort of AT patients recruited through the AT Society a national charitable organisation     involved in providing support to families with this condition and in fostering education and     research in the field.   "
214223|NCT00656422|"     The main objective of this clinical trial is to investigate hepatic fat as the primary     endpoint along with body fat, and weight changes after initiation of a basal insulin therapy     together with data acquisition that is today's standard in studies investigating obesity and     eating patterns with insulin detemir and insulin glargine.   "
214224|NCT00656435|"     Persistent or recurrent vitreous hemorrhage after vitrectomy for diabetic retinopathy     complications is a common occurrence with an incidence of 12% to 63%. This complication may     prolong vitreous clear-up and delay visual rehabilitation significantly, and sometimes     requires additional procedures or surgery.      The causes of bleeding are diverse. Evidence suggests fibrovascular proliferation from the     sclerotomy sites or from the vitreous base may be an important source of recurrent vitreous     hemorrhage; other sources of bleeding include iatrogenic intraoperative injury of retinal     vessels, and incomplete removal of fibrovascular tissues.      We have reported on the possible benefit of peripheral retinal cryotherapy and cryotherapy     treatment of sclerotomy sites to prevent delayed-onset recurrent vitreous hemorrhage, and the     possible benefit of intravitreal long-acting gas to reduce the occurrence of early     postoperative recurrent vitreous hemorrhage, especially for cases with active fibrovascular     proliferation. However, minor recurrent vitreous hemorrhage and prolonged reabsorption of     lysed blood clots from surgical trauma remain important factors to cause media opacity long     enough to prevent quick visual rehabilitation.      Intravitreal bevacizumab has been noted to induce rapid regression of retinal and iris     neovascularization in proliferative diabetic retinopathy. Further, presurgical administration     of intravitreal bevacizumab may reduce intraoperative bleeding during membrane dissection in     PDR with traction retinal detachment. We hypothesize that presurgical treatment of     intravitreal bevacizumab may reduce intraoperative bleeding and the amount of residual blood     clots, while intraoperative infusion of long-acting gas may facilitate post-operative     recovery of surgically injured retinal vessels. These combined effects would thus enhance     early clear-up of vitreous opacity from clot lysis and recurrent retinal bleeding. To     investigate this hypothesis, a clinical prospective study was undertaken to evaluate the     effects of bevacizumab pretreatment combined with intravitreal infusion of long-acting gas on     the clearance speed and the recurrence rate of early postoperative vitreous hemorrhage in     vitrectomy for active diabetic fibrovascular proliferation.   "
214225|NCT00656448|"     The goal of this clinical research study is to find out if Procrit (epoetin alfa) will help     decrease the need for blood transfusions in patients who have Acute Myelogenous Leukemia     (AML) or High-risk Myelodysplastic Syndrome (MDS) and are receiving chemotherapy. Researchers     also want to learn about the remission rates (rates of recovery) in patients with cancer who     have received treatment with epoetin alfa. The safety and effectiveness of this therapy will     also be studied.   "
214226|NCT00656461|"     This is an open-label study to determine the highest dose of MKC-1 that may be administered     daily on a continuous basis for patients with advanced or refractory solid tumors.   "
214227|NCT00656474|"     Study is intended to evaluate safety and efficacy parameters in patients treated with     GLYC-101 gel or placebo after laser ablation.   "
214228|NCT00656487|"     The purpose of this study is to find out more about cognitive functioning in people who are     cannabis dependent, relative to people who do not use cannabis, and how their brains process     information after one month of not using cannabis. An additional goal is to characterize the     severity of cannabis dependence using precipitated and naturalistic withdrawal with a double     blind, placebo controlled, single administration of rimonabant. Research assessments occur     bi-weekly throughout this 28 day study.   "
214229|NCT00656500|"     Elective surgery represents a teachable moment to deliver tobacco interventions. The overall     goal of this proposal is to increase the utilization of the QUITPLANSM Helpline by surgical     patients who smoke. Two specific aims will be pursued using a multidisciplinary research     team. In the first aim, we will develop a practice-based intervention to promote QUITPLANSM     Helpline utilization by surgical patients (Specific Aim 1A) using a combination of key     informant interviews (approximately 30 subjects), and focus groups (approximately 25     subjects) then develop methods to educate providers in its implementation (Specific Aim 1B)     and test their effectiveness in approximately 20 providers. In the second aim, we will     perform a randomized clinical trial of this intervention in 300 patients scheduled for     elective surgery, with the primary outcome being utilization of the QUITPLANSM Helpline     (Specific Aim 2). Subjects will be randomized to receive either the intervention developed in     Specific Aim 1, or a brief control intervention.   "
217213|NCT00697398|"     Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic     stimulation (rTMS) was thus suggested in this indication.   "
214230|NCT00656513|"     RATIONALE: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) and     pilocarpine may help to relieve chronic xerostomia (dry mouth). It is not yet known which     remedy is more effective in treating chronic dry mouth caused by radiation therapy in     patients with head and neck cancer.      PURPOSE: This randomized phase II/III trial is studying ALTENS to see how well it works     compared with pilocarpine in treating chronic dry mouth caused by radiation therapy in     patients with head and neck cancer.   "
214231|NCT00656526|"     To relieve post laminectomy pain, we have tried intraoperative perineural injection of     lidocaine right after the exposure in expecting that this would be preemptive analgesia by     blocking the nerve transmission so that postoperative pain starts later and lighter.   "
214232|NCT00656539|"     The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic     solution, 1% on signs and symptoms of blepharitis.   "
214233|NCT00656552|"     Escitalopram has been claimed to have the highest selectivity for the human serotonin     transporter relative to the noradrenaline or dopamine transporters. This might be associated     with greater clinical efficacy. Most adverse events reported by escitalopram-treated patients     are mild and transient.      In this study, we compare escitalopram with placebo in the treatment of PE.   "
214234|NCT00656565|"     Adequate administration of drugs via dry powder inhalers is dependent on adequate inspiratory     flow rates and volumes. These vary according to the device being used and its resistance. The     dry powder inhaler device under investigation is a device approved by the Therapeutic Goods     Administration (ARTG no. 196255) for use with dry powder mannitol. Dry powder mannitol is     currently being investigated as a treatment for bronchiectasis. We wish to measure the     inspiratory flow characteristics of both the low and high resistance devices amongst a group     of subjects with bronchiectasis.      We propose that the majority of subjects investigated with varying lung function will achieve     adequate flow during a controlled inspiration.   "
214235|NCT00656578|"     The primary purpose of this study is to compare the analgesic efficacy of a single     intraoperative administration of 4975 vs. Placebo in the management of acute postoperative     pain in patients undergoing bunionectomy.      Secondary objective of this study is to evaluate the safety and tolerability of a single     intraoperative administration of 4975.   "
214236|NCT00656591|"     An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for     Pregnant Women in Nepal to Reduce Fetal & Infant Mortality and to Improve Fetal Growth &     Cognitive Development in Infancy   "
214237|NCT00656604|"     RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance     imaging(DCE-MRI), magnetic resonance spectroscopy (MRS), and tissue proteomics, may help     doctors find and diagnose breast cancer and plan the best treatment.      PURPOSE: This clinical trial is studying MRI and MRS with or without tissue proteomics     analysis to see how well they work in evaluating healthy women and women who are undergoing     surgery for breast cancer.   "
214238|NCT00656617|"     The goal of this clinical research study is to find the highest safe dose of vorinostat that     can be given in combination with idarubicin and ara-C for the treatment of AML and high-risk     MDS.      Once the highest safe dose is found, researchers will then try to learn if this combination     treatment can help to control AML and high-risk MDS in newly diagnosed patients. The safety     of this treatment combination will also be studied.   "
214239|NCT00656630|"     The purpose of this study is to develop and validate a human laboratory model for prediction     of medication efficacy in clinical trials for relapse prevention in alcohol dependence.   "
214240|NCT00656643|"     The purpose of this study is to determine the safety and efficacy of an ocular sirolimus     (rapamycin) formulation at various doses in patients with diabetic macular edema.   "
214241|NCT00656656|"     Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies     against certain proteins important for maintaining skin integrity. Protein A immunoadsorption     is a dialysis-like technique selectively removing the antibodies from patient's blood.     Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for     production of antibodies in the patients blood that, in turn, lead to clinical signs of     pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that     may be used to suppress autoantibody production in pemphigus. While each of these three     therapies had been used to treat pemphigus, none was shown effective in all cases. The     hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and     dexamethasone is more effective that either of these treatments alone in achieving a rapid     and durable improvement or cure in patients with pemphigus.   "
214269|NCT00648440|"     The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5     mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose     administration under fed conditions.   "
214959|NCT00657527|"     The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8     weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with     coronary artery disease.   "
214242|NCT00656669|"     The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant     (given before surgery) treatment for patients that have either inoperable or operable breast     cancer. This treatment can help shrink the tumors so they can be removed to help prevent the     cancer from spreading to other parts of the body. This study is being done to test the impact     of adding sunitinib as a single-agent (Segment 1), followed by sunitinib plus paclitaxel     (Segment 2), followed by doxorubicin and cyclophosphamide (Segment 3). We hope the addition     of sunitinib will make the treatment more effective, but we don't know if this is true.   "
214243|NCT00656682|"     The purpose of this study is to determine if providing free-of-charge access to a group-based     lifestyle intervention delivered in partnership with the community is cost-effective for the     prevention of type 2 diabetes.   "
214270|NCT00648453|"     To determine whether in the laser Doppler flowmetric parameters characteristic of endothelial     dysfunction at patients with clinically manifest atherosclerosis any change can be detected     at plavix (clopidogrel) treatment. Laser Doppler /LD/ measurement combined with iontophoresis     evaluates the effect of acetylcholine /ACh/ /endothelium dependent/ and sodium nitroprusside     /NSP/ /endothelium independent/ on the microcirculation of the skin   "
214244|NCT00656695|"     Cyclosporine is the key drug in organ transplantation. In Iran the investigators have more     than 2500 new renal transplantation each year and because of this the government pay a huge     amount of money for subsiding the imported cyclosporine in the form of Neoral. Recently an     Iranian drug company introduced this drug in the name of Iminoral which has been approved by     different authorities in Iran and abroad, (including the Ministry of Health in Iran and also     European Directorate for the Quality of Medicines Certification Unit and FDA(Department of     Health and Human Services,Center for Drug Evaluation and Research)). The investigators study     is the first clinical trial to compare the effect of Iminoral versus Neoral in preventing     acute rejection in renal transplantation and also to compare the side effects of these two     drugs.   "
214245|NCT00656708|"     The purpose of this study is to determine whether Kerlix AMD gauze will decrease the     incidence of healthcare associated infections in burn patients. Kerlix AMD gauze will be     applied to all patients with open wounds admitted to the burn unit during the prospective     portion of the study. All consenting patients will be assessed for hospital associated     infections and outcomes. We hypothesis that burn patients will have a decreased number of     hospital associated infections compared to historical controls.   "
214246|NCT00656721|"     Considering that respiratory physiotherapy lack scientific evidence to support its     application in the treatment of several obstructive diseases, this investigation was designed     to evaluate the hypothesis that Flutter Valve can improve the airway clearance of     hypersecretive bronchiectasis patients.   "
214247|NCT00656734|"     To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear     cell renal cell carcinoma (Kidney cancer).   "
214248|NCT00656747|"     A study to assess the safety and efficacy of moxifloxacin compared to that of     amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic     bronchitis.   "
214249|NCT00656760|"     Historically metastatic squamous cell carcinoma in a cervical lymph node from an occult     primary malignancy of the head and neck was evaluated with panendoscopy and biopsies of high     risk areas, such as the base of tongue, nasopharynx, and tonsils. This diagnostic protocol     identifies the primary malignancy in about 50% of cases. In recent years, the availability of     CT has slightly increased the detection rate to 65% when used as an adjunct to the     traditional work-up. Studies using PET as an adjunct are conflicting with detection rates     ranging up to 75%. Currently, no prospective study has analyzed the role of the PET-CT fusion     in the work-up of an occult primary malignancy of the head and neck. This study will compare     the detection rate of the traditional work-up to a new protocol involving a pre-operative     diagnostic PET-CT.   "
214250|NCT00656773|"     Obtaining high-quality analgesia in prehospital patients with severe pain is an important     treatment objective for medical team. Opioids are recognized as the treatment of choice for     relief of severe acute pain. Recommended initial analgesia of patients with severe acute     pain, defined as a visual analog scale or a numerical rating scale (NRS) score of 60/100 or     higher, in a prehospital setting in France consists of the administration of opioids by the     medical staff of mobile intensive care units. The intravenous administration of morphine is     usually considered as the gold standard for postoperative acute pain relief because of its     rapid transport from the blood to target tissues after intravenous injection, its     long-lasting analgesic effect without any plateau, and its well-known pharmacokinetics.     Nevertheless, the short-acting opioid sufentanil might be preferable to the traditional     long-acting morphine for prehospital analgesia because of its even faster onset of action and     shorter duration than morphine. There is no study, to our knowledge, comparing the clinical     efficacy of sufentanil vs morphine in a prehospital setting. This randomized double-blind     group clinical trial is designed to determine the best intravenous opioid titration protocol     by comparing sufentanil and morphine for medical prehospital treatment of adult patients with     severe acute pain. Eligible patients with a numerical rating scale (NRS) score of 60/100 or     higher will be randomly allocated to receive either 0.15 µg/kg sufentanil then 0.075 µg/kg     every 3 minutes (group A) or 0.15 mg/kg morphine then 0.075 mg/kg every 3 minutes (group B)     intravenously. The decision to provide opioid analgesia including titration of subsequent     doses of narcotic is the responsibility of physicians and intravenous analgesia will be given     and titrated according to the pain score every 3 minutes. The drugs will be administered by     the physician from syringes of similar appearance prepared by the nurse who is not otherwise     involved in the study. The protocol-defined primary outcome measure is the percentage of     patients with pain relief (with a NRS score of 30/100 or lower) 15 minutes after the first     injection. Secondary outcomes include pain score comparisons every 3 minutes within the first     30 minutes and comparison of adverse events. The physician blinded to the analgesic treatment     groups will do all assessments of patients. The safety evaluation will include non invasive     monitoring of blood pressure, heart rate, respiratory rate, oxygen saturation by pulse     oximetry (Spo2), and a sedation scale (0, patient is awake; 1, patient is with intermittent     sleeping; 2, patient is sleeping, awakened by verbal stimulation; 3, patient is sleeping,     awakened by tactile stimulation; 4, patient is not aroused by stimulation) at these periods.     Fifteen minutes after the first injection, overall patient and investigator satisfaction with     analgesia was recorded.   "
214251|NCT00656786|"     This is a clinical research study of an experimental new medication, Menadione Topical Lotion     (MTL). The study lotion is experimental and has not been approved for public use. Hana     Biosciences, Inc., the company that is developing MTL, is the sponsor of this study. EGFR     inhibitors are used to treat non-small cell lung cancer (NSCLC), pancreatic cancer,     colorectal cancer, breast cancer and head and neck cancer. One of the side effects of EFGR     inhibitors is skin toxicities including an acneform skin rash.      This study is a Phase 1 study. The main purposes of this study are:        -  Evaluate the safety and tolerability of Menadione Topical Lotion as an emergent and          pre-emergent treatment for EGFR inhibitor-associated rash        -  Evaluate the systemic absorption and bioavailability of Menadione Topical Lotion as an          emergent and pre-emergent treatment for EGFR inhibitor-associated rash      It is planned that up to 24 patients undergoing EGFR inhibitor therapy will take part in this     study at multiple clinical centers.   "
214252|NCT00656799|"     The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium     complex; it's safety and efficacy in participants with severe renal impairment.   "
214253|NCT00656812|"     The purpose of this trial is to evaluate whether a Rituximab plus 2 CdA combination therapy     is effective and safe in the treatment of patients with advanced or relapsed lymphoma of the     mucosa associated lymphoid tissue (MALT).   "
214271|NCT00648466|"     The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan     succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1     x 100 mg) dose administration under fasting conditions.   "
214272|NCT00648479|"     We intend to include10 patients in this study and trial. Prior to treatment they will sign an     informed consent form, stating that they are acquainted with the surgical procedure and     study, and that they consent to participate in the study.      Five patients will undergo regular operation with Universal tibial reamed nail (AO-Synthes)     using the fluoroscopy device: OEC 9800 (GENERAL ELECTRIC). five patients will undergo the     same operation using the new navigation system:The Guiding star method.      The allocation will be random.   "
215294|NCT00668291|"     Cohort CNC-PPNAD will be investigated with clinical, genetic, biological and imaging work-up     every year during 3 years. Cohort L-MC will be investigated clinically at inclusion and a     PERKAR1A genotype will be performed.   "
214254|NCT00656825|"     Transforming growth factor-beta 1 (TGF-β1) is consistently over expressed in most fibrotic     diseases and displays a variety of profibrotic effects in fibroblasts. Activation of TGF-β     receptors induces the activation of several kinase signalling cascades leading to the     phosphorylation of SMAD proteins as well as to the activation of SMAD-independent kinases     that collectively activate ECM synthesis and fibroblast growth and differentiation into     myofibroblasts. TGF-β1 is one of the main mediators in the fibrotic process, associated to     both scarring and a long list of pathologies related to chronic inflammation and which affect     all type of organs and tissues. An increase in TGF-β1 mRNA and protein levels has been     described in these processes. Peptide 144 (P144) is the acetic salt of a 14mer peptide from     human TGF-β1 type III receptor (betaglycan). P144 TGF-β1-inhibitor has been specifically     designed to block the interaction between TGF-β1 and TGF-β1 type III receptor, thus blocking     its biological effects. P144 has shown significant antifibrotic activity in mice receiving     repeated subcutaneous injections of bleomycin, a widely accepted animal model of human     scleroderma, and could contribute to the development. The purpose of this study is to assess     the tolerability and safety of topical application of P144 in healthy volunteers.   "
214255|NCT00656838|"     FIBER is 4-year study that will evaluate the implementation of a large-scale population-based     colorectal cancer screening patient reminder and coordinated follow-up program. The CRC     screening program began in 2007 with Kaiser Permanente Northwest (KPNW),a not-for- profit,     integrated health system in Oregon and Washington. FIBER consists of 1)a practical randomized     controlled trial at the start of the program, followed by 2) a longer-term cohort study as     all remaining eligible patients receive the program, and 3)a qualitative evaluation. FIBER     will evaluate the factors that are associated with implementation success across multiple     levels: patient, primary care provider (PCP) team, specialists (gastroenterologists, general     surgeons, pathologists), and other health plan staff and systems.   "
214256|NCT00656851|"     We hypothesize that the hearts of HIV+ people with The Metabolic Syndrome use and oxidize     fats and sugars inappropriately, and that this may impair the heart's ability to pump blood.     We hypothesize that exercise training or pioglitazone (Actos) will improve fat and sugar     metabolism in the hearts of HIV+ people with The Metabolic Syndrome. This study will advance     our understanding of cardiovascular disease in HIV+ people, and will test the efficacy of     exercise training and pioglitazone for improving insulin resistance, heart metabolism and     heart function in this at risk population.   "
214257|NCT00656864|"     Incretin hormones are hormones produced by the gut in response to food intake. These hormones     help the body to control the metabolism of glucose (sugar). In particular, two incretin     hormones (GLP-1 and GIP) cause the pancreas to secrete more insulin in response to high blood     glucose levels. This helps the body to metabolize the glucose more effectively, lowering     blood sugar levels. GLP-1 and GIP do not work as well in patients with type 2 diabetes (T2DM)     as in subjects who do not have diabetes. This study tests whether a medicine called     pioglitazone (Actos), which is commonly used to treat T2DM, improves the ability of GIP to     increase insulin secretion.      To address this question the investigators will recruit patients with T2DM whose diabetes is     controlled with either diet and exercise or with metformin (another medicine commonly used to     treat T2DM). Subjects will undergo measurement of body fat by DEXA scanning and a series of     studies to characterize their metabolism. These studies include an oral glucose tolerance     test (a test sometimes used to diagnose diabetes), a mixed-meal challenge (to measure how     much GLP-1 and GIP are produced in response to a meal) and measurement of insulin secretion     in response to glucose and GIP given through a vein. The investigators will also obtain small     samples of fat (from just under the skin of the belly) using a needle to measure levels of     the receptor for GIP. Subjects will then be randomly assigned to 12 weeks of treatment with     either pioglitazone or matching placebo (an inactive tablet that does not contain     medication). The dose of pioglitazone will be increased during the first 4 weeks to the     maximum prescribed dose of 45 mg per day. Subjects will be seen every 2-4 weeks during the     treatment phase of the study. After 12 weeks of treatment all studies performed at the     beginning of the study will be repeated. The pioglitazone treatment will continue until the     end of testing, approximately 4 weeks.      The results of this study may give us information about why glucose control deteriorates in     T2DM. This information might also lead to new ways to prevent or treat T2DM.   "
214258|NCT00648297|"     The objective of this study was to investigate the bioequivalence of Mylan's     nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets     following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose administered under fed conditions.   "
214259|NCT00648310|"     Despite the great number of reports about the efficacy of oestrogens or antimuscarinics on     OAB symptoms, so far no author has tried to investigate whether the concomitant     administration of these two drugs, acting on two different pathophysiological mechanisms,     could have a synergic effect reducing the rate of non-responders to treatment.   "
214260|NCT00648323|"     The primary objectives were to determine the efficacy and safety of the GITS formulation of     Doxazosin in Taiwanese patients with prostate enlargement.   "
214261|NCT00648336|"     The objective of this study was to investigate the bioequivalence of Mylan's mercaptopurine     50 mg tablets to Gate's Purinethol® 50 mg tablets following a single, oral 50 mg (1 x 50 mg)     dose administered under fasting conditions.   "
214262|NCT00648349|"     The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole     sodium delayed-release 20 mg tablets to Eisai's Aciphex® delayed-release 20 mg tablets     following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.   "
214263|NCT00648362|"     The objective of this study was to investigate the bioequivalence of Mylan's glimepiride 1 mg     tablets to Aventis Amaryl® 1 mg tablets following a single, oral 1 mg (1 x 1 mg) dose     administered under fasting conditions.   "
214264|NCT00648375|"     This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in     people with post-traumatic stress disorder.   "
214265|NCT00648388|"     The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100     mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg)     dose administered under fasting conditions.   "
214266|NCT00648401|"     The objective for this study was to investigate the bioequivalence of Mylan's verapamil HCl     extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules     following a single, oral 300 mg (1 x 300 mg) dose administration under fed conditions.   "
214267|NCT00648414|"     The objective of this study was to investigate the effect of clinical procedures on the drug     delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals     Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen     Pharmaceutica by ALZA Corporation.   "
214268|NCT00648427|"     The objective of this study was to investigate the bioequivalence of Mylan's paroxetine     hydrochloride controlled-release 25 mg tablets to GSK's Paxil CR™ 25 mg tablets following a     single, oral 25 mg (1 x 25 mg) dose administered under fasting conditions.   "
214273|NCT00648492|"     The objective of this study is to investigate the bioequivalence of Mylan's metformin     hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single,     oral 500 mg (1 x 500 mg) dose administered under fed conditions.   "
214274|NCT00648505|"     The objective of this study was to investigate the bioequivalence of Mylan's glipizide and     metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets     following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fed     conditions.   "
214275|NCT00648518|"     The objective of this study was to investigate the bioequivalence of Mylan's metformin     hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single,     oral 750 mg (1 x 750 mg) dose administered under fasting conditions.   "
214276|NCT00648531|"     The objective of this study was to investigate the bioequivalence of Mylan balsalazide     disodium 750 mg capsules and Salix Colazal® 750 mg capsules following a single, oral 2250 mg     (3 x 750 mg) dose administration under fasting conditions.   "
214277|NCT00648544|"     This study was designed to compare the rate and extent of absorption of pravastatin sodium     from the following formulations under fed conditions:        1. Pravastatin Sodium 80 mg Tablets (Genpharm Inc. Canada)        2. Pravachol® 80 mg Tablets (Bristol-Myers Squibb Co., U.S.A.) Bioequivalence of these          formulations was assessed for pravastatin.      Based on the results from this study, these two 80 mg pravastatin tablet formulations     demonstrated bioequivalence under the single-dose fed conditions.   "
214278|NCT00648557|"     The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine     sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x     200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine     healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label,     randomized, two-period, two-treatment, single-dose crossover study conducted by Dr. James D.     Carlson at PRACS Institute, Ltd., Fargo, ND. Statistical analysis of the data revealed that     90% confidence intervals were within the acceptable bioequivalent range of 80% and 125% for     the natural log transformed parameters LNAUC0-48hr and LNCPEAK for baseline corrected total     L-thyroxine. This study demonstrated that Mylan's 200 μg levothyroxine sodium tablets are     bioequivalent to Abbott's Synthroid® 200 μg tablets following a single, oral 600 μg (3 x 200     μg) dose under fasting conditions   "
214279|NCT00648570|"     The objective of this study was to investigate the bioequivalence of Mylan's escitalopram     oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x     20 mg) dose administered under fasting conditions.   "
214280|NCT00648583|"     The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24     mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose     administered under fed conditions.   "
214281|NCT00648596|"     To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall     Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the     Erectile Function [EF] domain of the International Index of Erectile Function [IIEF]).     Furthermore, to determine if the improvement obtained in self-esteem was related to the main     erectile dysfunction (ED) co-morbidities type and/or number.   "
214282|NCT00648609|"     The purpose of this study is to compare in home support services for patients with COPD with     usual care. The study is designed to evaluate the impact of an interdisciplinary palliative     care team on community based self management of advanced COPD.      A total of thirty patients will be enrolled into this study. Twenty patients will be randomly     assigned to receive usual care, and ten patients will be randomly assigned to usual care plus     in home support services. This study will use objective criteria to identify patients with     COPD likely to benefit from home based palliative care services. The patients will undergo     initial assessment by medical, social work, and spiritual care personnel followed by a family     meeting to establish a care plan. Periodic scheduled visits, and as needed unscheduled visits     to address urgent needs will occur over one year's time in an attempt to return patients with     COPD to the center of decision making regarding their care, avoid acute exacerbations and     thereby avoid unscheduled clinic and ER visits. Patients will complete the QOL survey and     symptom assessment scale upon initial intervention. After obtaining information from all     patients who qualify for the study, participants will be randomized into cohorts. Those who     are randomized to serve as cases will be provided with community based self management     services by an interdisciplinary palliative care team. The control group will receive     standard care. At the conclusion of 12 months both cases and controls will again complete the     QOL survey,medical utilization, and symptom assessment.   "
214283|NCT00648622|"     The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12.5     mg tablets to GSK's Coreg® 12.5 mg tablets following a single, oral 12.5 mg (1 x 12.5 mg)     dose administered under fed conditions.   "
214284|NCT00648635|"     The goal of this study is to learn how the treatment given to patients with recurrent rectal     cancer affects their well being and quality of life.   "
214306|NCT00648934|"     The objective of this study was to investigate the bioequivalence of Mylan's topiramate     sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a     single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.   "
214285|NCT00648648|"     This study will investigate MK1775 alone and in combination with one of the following three     drugs: gemcitabine, cisplatin, and carboplatin in patients with advanced solid tumors. The     purpose of the study is to test safety and tolerability of MK1775 alone and in combination,     and to find the maximum tolerated dose (MTD) of MK1775 as monotherapy and in combination     therapy.   "
214286|NCT00648661|"     The objective of this study was to investigate the bioequivalence of Mylan's escitalopram     oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x     20 mg) dose administered under fed conditions.   "
214287|NCT00648674|"     Single site clinical study utilizing the novel technology of microarrays to identify and     characterize the molecular mechanisms through which Apligraf promotes healing of venous leg     ulcers.   "
214332|NCT00649272|"     The objective of this study was to investigate the bioequivalence of Oxybutynin Chloride     Extended-Release Tablets, 15 mg (Mylan Pharmaceuticals Inc.) to Ditropan XL® Extended-     Release Tablets, 15 mg (ALZA Corporation; Distributed and marketed by: Ortho-McNeil     Pharmaceuticals Inc.) following a single, oral 15 mg dose (1 x 15 mg tablet) under fasting     conditions.   "
214288|NCT00648687|"     Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have     ophthalmologic examination for ROP at 6 weeks old. They will be randomized blindly to receive     2 ml of 12.5% dextrose in water (D12.5W) orally five minute before examination (intervention     group) or nothing (control). NIPS scale will be applied two minutes before examination and     two minutes after examination.   "
214289|NCT00648700|"     The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine     sodium 300 μg tablets to Lloyd's Levothroid® 300 μg tablets following a single 600 μg (2 x     300 μg) dose administered in healthy adult volunteers under fasting conditions. Statistical     analysis of the data revealed that 90% confidence intervals were within the acceptable     bioequivalent range of 80% and 125% for the natural log transformed parameters LNAUC0-48hr     and LNCPEAK for baseline corrected total levothyroxine.   "
214290|NCT00648713|"     The objective of this study was to investigate the bioequivalence of Mylan's terbinafine     hydrochloride tablets to Novartis' Lamisil® tablets following a single, oral 250 mg (1 x 250     mg) dose administered under fed conditions.   "
214291|NCT00648726|"     To validate the efficacy and safety of azithromycin for the treatment of Chinese patients     hospitalized with community-acquired pneumonia (CAP), compared with cefuroxime or the     combination of cefuroxime plus oral erythromycin.   "
214292|NCT00648739|"     The purpose of this study is to determine the safety and best dose of ALXN6000 in treating     relapsing or refractory B-CLL or MM and to study how ALXN6000 may help the immune system     fight cancer.   "
214293|NCT00648765|"     The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1     mg capsules to Shire US's Agrylin® 1 mg capsules following a single, oral 1 mg (1 x 1 mg)     dose administration under fed conditions.   "
214294|NCT00648778|"     The objective of this study was to investigate the bioequivalence of Mylan loxapine succinate     25 mg capsules to Watson Loxitane 25 mg capsules following a single, oral 25 mg (1 x 25 mg)     dose administration under fasting conditions.   "
214295|NCT00648791|"     The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg     tablets to Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose     administration under fasting conditions.   "
214296|NCT00648804|"     The objective of this study was to investigate the bioequivalence of Mylan's ondansetron     orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a     single, oral 8 mg (1 x 8 mg) dose administered under fed conditions.   "
214297|NCT00648817|"     Metabolic changes commonly occur in HIV therapy. The purpose of this study is to assess the     impact on insulin sensitivity from the administration of tenofovir disoproxil fumarate 300 mg     compared with placebo in non-HIV-1 infected healthy adult males. Additionally, endothelial     function, adipocytokines and lipids will be monitored.   "
214298|NCT00648830|"     The objective of this study was to investigate the bioequivalence of Genpharm's     clarithromycin tablets following a single, oral 250 mg (1 x 250 mg) dose compared to the     Biaxin® filmtab® (Abbott Laboratories USA) administered under fasted conditions. Thirty-four     (34) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were     randomized, in this four-period, two-treatment crossover bioequivalence study conducted by     Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.      Statistical analysis of the data reveals that 90% confidence intervals are within the     acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters     AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 250 mg tablets     are bioequivalent to Biaxin® filmtab® 250 mg tablets (Abbott Laboratories USA) administered     under fasted conditions.   "
214299|NCT00648843|"     The objective of this study was to investigate the single-dose relative bioavailability of     Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following     an oral, single 20 mg (4 x 5 mg) dose under fed conditions.   "
214300|NCT00648856|"     The objective of this study was to investigate the bioequivalence of Mylan's sertraline     hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100     mg (1 x 100 mg) dose administration under fed conditions.   "
214301|NCT00648869|"     Single-dose, randomized, open-label, cross over study. The study will have an open-label, 3     period, 3 treatments, and randomized design.      Each volunteer will receive a Metformin gum 2x250mg, Metformin gum 1x250mg & Metformin tablet     500mg   "
214302|NCT00648882|"     The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine     sodium 300 mcg tablets to Abbott's Synthroid® 300 mcg tablets following a single, oral 600     mcg dose (2 × 300 mcg) administered under fasting conditions.   "
214303|NCT00648895|"     The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another     beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the     mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other     biomarkers.   "
214304|NCT00648908|"     The purpose of this study is to evaluate the safety, tolerability and activity of     Fampridine-SR when administered for up to 36 additional months, or until it becomes     commercially available whichever comes first, in subjects who previously participated in     Acorda Therapeutics Protocol MS-F203.   "
214305|NCT00648921|"     The objective of this study was to investigate the bioequivalence of Mylan's olanzapine 5 mg     tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose     administered under fasting conditions.   "
214307|NCT00648947|"     The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel     bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a     single, oral 75 mg (1 x 75 mg) dose administered under fasting conditions.   "
214333|NCT00649285|"     The objective of this study was to investigate the bioequivalence of Mylan's nitrofurantoin     monohydrate/macrocrystals capsules to Procter & Gamble's Macrobid® capsules following a     single, oral 100 mg (1 x 100 mg) dose under fed conditions.   "
214334|NCT00649298|"     This study will assess clinical outcomes of extended weekly hours of haemodialysis (>= 24     hours per week) compared with standard hours of haemodialysis (<=18 hours/week) in people     with ESKD.   "
214335|NCT00649311|"     The purpose this study is to compare the efficacy of eplereonone and losartan in patients     with mild to moderate hypertension.   "
214308|NCT00648960|"     The objective of this study was to investigate the bioequivalence of Genpharm's     clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the     Biaxin® filmtab® (Abbott Laboratories USA) administered under fasting conditions. Sixty-four     (64) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were     randomized, in this two-period, two-treatment crossover bioequivalence study conducted by     Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.      Statistical analysis of the data reveals that 90% confidence intervals are within the     acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters     AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets     are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered     under fasting conditions.   "
214309|NCT00648973|"     The study was to determine if the drug worked to relieve nasal congestion experienced by     people with seasonal allergies.   "
214310|NCT00648986|"     The purpose of this study is to determine whether topical tazarotene (Tazorac), a     receptor-selective synthetic retinoid that normalizes epidermal differentiation, ameliorates     signs and symptoms of brittle nails.   "
214311|NCT00648999|"     To demonstrate that patients treated with Kaletra have an improvement in their quality of     life compared to the quality of life they had with their previous NRTI therapy.   "
214312|NCT00649012|"     The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl     45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose     administration under fed conditions.   "
214313|NCT00649025|"     The medications being used in this study are individually approved by the Food and Drug     Administration (FDA). The medication under investigation is a combination of two medications     in one inhaler. The purpose of this study is to determine how well your asthma is controlled     when taking one of the three treatment.   "
214314|NCT00649038|"     The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and     hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets     following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fed     conditions.   "
214315|NCT00649051|"     The objective of this study was to investigate the bioequivalence of Mylan metolazone 2.5 mg     tablets to Celltech Zaroxolyn® 2.5 mg tablets following a single, oral 10 mg (4 x 2.5 mg)     dose administration under fasting conditions.   "
214316|NCT00649064|"     The purpose of this study is to see if differences exist in outcome in patients with     schizophrenia or schizoaffective disorder who were switched from other antipsychotics to     ziprasidone.   "
214317|NCT00649077|"     The objective of this study was to investigate the bioequivalence of Mylan's meloxicam 15 mg     tablets and Boehringer Ingelheim's Mobic® 15 mg tablets following a single, oral 15 mg (1 x     15 mg) dose administration under fasting conditions.   "
214318|NCT00649090|"     The purpose of this study was to give access to postmenopausal women with estrogen sensitive     primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use     of tamoxifen and to collect all serious adverse events.   "
214319|NCT00649103|"     The objective of this study was to investigate the bioequivalence of Mylan quinapril     hydrochloride 40 mg tablets compared to Parke-Davis Accupril® 40 mg tablets following a     single, oral 40 mg (1 x 40 mg) dose under fasting conditions.   "
214320|NCT00649116|"     The objective of this study was to investigate the bioequivalence of Mylan's metoprolol     tartrate tablets to Novartis's Lopressor® tablets following a single, oral 100 mg (1 x 100     mg) dose administered under fed conditions.   "
214321|NCT00649129|"     The objective of this study was to investigate the single-dose relative bioavailability of     Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following     an oral, single 20 mg (2 x 10 mg) dose under fasting conditions.   "
214322|NCT00649142|"     Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair.     However no prospective study has investigated potential predisposing factors for development     of pain, including genetic, psychosocial and detailed neurophysiological assessment of     surgical method.      The current study will assess the above factors in a prospective study.   "
214323|NCT00649155|"     The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin     extended-release 500 mg tablets to Bayer's Cipro® XR 500 mg tablets following a single, oral     500 mg (1 x 500 mg) dose administered under fasting conditions.   "
214324|NCT00649168|"     The objective of this study was to assess the single-dose relative bioavailability of Mylan     Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine     mesylate capsules, following the administration of a 10 mg dose, under fed conditions.   "
214325|NCT00649181|"     The objective of this study was to investigate the bioequivalence of Mylan metolazone 5 mg     tablets to Celltech Zaroxolyn® 5 mg tablets following a single, oral 10 mg (2 x 5 mg) dose     administration under fasting conditions.   "
214326|NCT00649194|"     The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole     sodium delayed-release 20 mg tablets relative to Eisai's Aciphex® delayed-release 20 mg     tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.   "
214327|NCT00649207|"     This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given     together with Whole Brain Radiation Therapy (WBRT) in treating patients with brain     metastases.   "
214328|NCT00649220|"     To investigate the potential to reduce concomitant antipsychotic medication use in subjects     with moderate dementia of Alzheimer's type, treated with memantine.   "
214329|NCT00649233|"     The objective of this study was to investigate the bioequivalence of Mylan metoprolol     tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets     following a single, oral 100/50 mg (1 x 100/50 mg) dose administration under fed conditions.   "
214330|NCT00649246|"     This is an observational study designed to help researchers understand the genetics and     pathogenesis of type 1 diabetes, and to identify biomarkers for disease and disease     complication prediction.   "
214331|NCT00649259|"     The objective of this study was to investigate the single-dose relative bioavailability of     Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following     an oral, single 20 mg (2 x 10 mg) dose under fed conditions.   "
214336|NCT00649324|"     The objective of this study was to investigate the bioequivalence of Mylan's     hydrochlorothiazide 50 mg tablets to Ivax's Hydrochlorothiazide 50 mg tablets following a     single, oral 50 mg (1 x 50 mg) dose administered under fasting conditions.   "
214337|NCT00649337|"     The purpose of this study is to determine whether addition of automated whole breast     ultrasound to the usual screening mammography in a population of asymptomatic women with     mammographically dense breasts will result in a significantly greater number of breast     cancers discovered than would be found by mammography alone.   "
214338|NCT00649350|"     The objective of this study was to investigate the bioequivalence of Mylan's metformin     hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single,     oral 750 mg (1 x 750 mg) dose administered under fed conditions.   "
214339|NCT00649363|"     The objective of this study was to investigate the bioequivalence of Mylan's ondansetron     orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a     single, oral 8 mg (1 x 8 mg) dose administered under fasting conditions.   "
214340|NCT00649376|"     The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180     mg tablets to Aventis' Allegra® 180 mg tablets following a single, oral 180 mg (1 x 180 mg)     dose administered under fasting conditions.   "
214341|NCT00649389|"     To determine the effectiveness of four different strength combinations of three approved     anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for     lowering blood pressure.   "
214342|NCT00649402|"     The objective of this study was to investigate the bioequivalence of Mylan amlodipine and     benazepril HCl 10 mg/20 mg to Novartis Lotrel® 10 mg/20 mg combination capsules following a     single, oral 10 mg/20 mg (1 x 10 mg/20 mg) dose administered under fed conditions.   "
214343|NCT00649415|"     To compare the analgesic efficacy, safety, and tolerability of valdecoxib versus piroxicam in     subjects with moderate to severe menstrual cramping pain associated with primary     dysmenorrhea.   "
214344|NCT00649428|"     The purpose of this study is to evaluate the safety profile and the treatment effect of     Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold     wrinkles.   "
214345|NCT00649441|"     The objective of this study was to investigate the bioequivalence of Mylan's quinapril HCl     and hydrochlorothiazide 20 mg/25 mg tablets to Parke-Davis' Accuretic™ 20 mg/25 mg tablets     following a single, oral 20 mg/25 mg (1 x 20 mg/25 mg) dose administered under fasting     conditions.   "
214346|NCT00649454|"     The objective of this study was to investigate the bioequivalence of Mylan's glipizide and     metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets     following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fasting     conditions.   "
214347|NCT00649467|"     The objective of this study was to investigate the bioequivalence of Mylan's topiramate     sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single,     oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.   "
214348|NCT00649480|"     The objective of this study was to investigate the bioequivalence of Mylan balsalazide     disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg     (3 x 750 mg) dose administration under fed conditions.   "
214349|NCT00649493|"     The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole     sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20     mg) dose administration under fed conditions.   "
214350|NCT00649506|"     The objective of this study was to evaluate the relative bioavailability of Mylan's     nitrofurantoin macrocrystals 100 mg capsules to Procter & Gamble's Macrodantin® 100 mg     capsules following a single, oral 100 mg (1 x 100 mg) dose in 28 healthy, adult, non-tobacco     using volunteers under fed conditions.   "
214351|NCT00649519|"     The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and     benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a     single, oral 10 mg/20 mg (1 x 10mg/20mg) dose administered under fasting conditions.   "
214352|NCT00649532|"     The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24     mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose     administered under fasting conditions.   "
214353|NCT00649545|"     The primary objective of this study is to assess the safety (by collecting adverse events and     serious adverse events) of adalimumab administered every other week to patients with     moderately to severly active rheumatoid arthritis who have failed prior disease-modifying     anti-rheumatic drugs (DMARDs).   "
214354|NCT00649558|"     The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl     45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose     administration under fasting conditions.   "
214355|NCT00649571|"     The objective of this study was to investigate the bioequivalence of Mylan's doxycycline     monohydrate 100 mg tablets to Par's Adoxa® 100 mg tablets following a single, oral 100 mg (1     x 100 mg) dose administered under fasting conditions.   "
214357|NCT00649597|"     The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and     hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets     following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting     conditions.   "
214358|NCT00649610|"     The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with     diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on     the patient's level of disability and quality of life was also studied.   "
214359|NCT00649623|"     The objective of this study was to investigate the bioequivalence of Mylan's olmesartan     medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1     x 40 mg) dose administered under fasting conditions.   "
214360|NCT00649636|"     The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine     hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg     (1 x 40 mg) dose administration under fasting conditions.   "
214361|NCT00649649|"     The objective of this study was to investigate the bioequivalence of Mylan quinapril     hydrochloride 40 mg tablets compared to Parke-Davis Accupril® 40 mg tablets following a     single, oral 40 mg (1 x 40 mg) dose under fed conditions.   "
214362|NCT00649662|"     The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin     extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single,     oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.   "
214363|NCT00649675|"     The objective of this study was to investigate the bioequivalence of Mylan's meloxicam 15 mg     tablets and Boehringer Ingelheim's Mobic® 15 mg tablets following a single, oral 15 mg (1 x     15 mg) dose administration under fed conditions.   "
214364|NCT00649688|"     The objective of this study was to investigate the bioequivalence of Mylan metoprolol     tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets     following a single, oral 100/50 mg (1 x 100/50 mg) dose administration under fasting     conditions.   "
214365|NCT00649701|"     The purpose of this study is to develop and test the efficacy of online HIV risk reduction     interventions among men who have sex with men.   "
214366|NCT00649714|"     The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100     mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg)     dose administered under fed conditions.   "
214367|NCT00649727|"     The objective of this study was to investigate the single-dose relative bioavailability of     Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following     an oral, single 20 mg (2 x 10 mg) dose under fed conditions.   "
214368|NCT00649740|"     The objective of this study was to investigate the bioequivalence of Mylan's topiramate     sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single,     oral 25 mg (1 x 25 mg) dose administered under fasting conditions.   "
214369|NCT00649753|"     The purpose of this study is to evaluate the relationship of pelvic blocking and protocol for     cranial adjusting with specific pain areas as outlined by Dr. Bertrand DeJarnette in the     Category II/sacroiliac protocol. An algometer will be used to determine the level of pain at     specific points before and after each treatment of pelvic blocking with or without cranial     adjusting.   "
214370|NCT00649766|"     The purpose of this project is to test two different types of health messages, one that is     developed for a specific group (targeted) and the other that is more personalized to     individuals (tailored), to see which is better at changing how often people have their eyes     examined. We hypothesize that people who get the tailored messages will be more likely to get     a dilated eye exam than people who receive the targeted messages.   "
214371|NCT00649779|"     The objective of this study was to investigate the bioequivalence of Mylan's albuterol     sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single,     oral 8 mg (1 x 8 mg) dose administered under fasting conditions.   "
214372|NCT00649792|"     The purpose of the study is to evaluate the safety, tolerability and activity of     Fampridine-SR when administered for up to 36 additional months in patients who previously     participated in the MS-F204 study or until it becomes commercially available, whichever comes     first.   "
214373|NCT00649805|"     The objective of this study was to investigate the bioequivalence of Mylan's verapamil HCl     extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules     following by a single, oral 300 mg (1 x 300 mg) dose administration sprinkled on one     tablespoon of applesauce under fasting conditions.   "
214374|NCT00649818|"     The objective of this study was to investigate the bioequivalence of Mylan's lorazepam 2 mg     tablets to Wyeth's Ativan 2 mg tablets following a single, oral 2 mg (1 x 2 mg) dose     administered under fasting conditions.   "
214375|NCT00649831|"     This study compared the clinical efficacy and safety of azithromycin with that of     amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with     an exacerbation of chronic bronchitis.   "
214376|NCT00649844|"     The purpose of this study is to compare the efficacy and safety of ziprasidone and clozapine     in schizophrenic patients who are resistant and/or intolerant to antipsychotic treatment   "
214377|NCT00649857|"     The objective of this study was to investigate the bioequivalence of Mylan's cetirizine HCl     tablets to Pfizer's Zyrtec® tablets following a single, oral 10 mg (1 x 10 mg) dose     administered under fed conditions.   "
214378|NCT00649870|"     The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir     hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a     single, oral 1000 mg (1 x 1000 mg) dose administration under fed conditions.   "
214379|NCT00649883|"     This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or     0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in     healthy children aged 6 to <60 months.   "
214380|NCT00649896|"     The primary objective of this study was to compare the adhesive quality of a new formulation     of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following     a single system application in 80 healthy postmenopausal female volunteers. As a secondary     objective, primary dermal irritation was assessed after removal of each transdermal system.   "
214381|NCT00649909|"     The efficacy of low dose aspirin appears to be substantially lower in diabetic patients,     compared to patients without diabetes.      We will perform an observational study where we follow up patients with uncontrolled type 2     Diabetes Mellitus and low response to aspirin (Aspirin Resistance), during a period of 6     months in the diabetic clinic. Our hypothesis is that glucose control will improve the     response to aspirin in those patients.   "
214382|NCT00649922|"     To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal     virus in subject with RA receiving adalimumab or placebo   "
214383|NCT00649935|"     The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600     mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg)     dose administered under fed conditions.   "
214384|NCT00649948|"     The objective of this study was to investigate the bioequivalence of Mylan's metformin     hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single,     oral 500 mg (1 x 500 mg) dose administered under fed conditions.   "
214445|NCT00657852|"     The aims of this study are to prospectively evaluate the efficacy of two intravenous     infusions of pamidronate 90 mg, associated with calcium and calcidiol, in the early     post-transplant period, on bone loss in liver transplant recipients, and to asses the safety     of this treatment.   "
214385|NCT00649961|"     Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may     reduce this risk. The unborn baby receives melatonin from the mother but following premature     delivery there maybe a period of prolonged melatonin deficiency. This deficiency may be     harmful because studies suggest that melatonin is important in protecting the brain and     reducing the risk of brain injury after preterm birth. The purpose of this study is to find     the ideal dose of melatonin to give to preterm babies. We intend to study a total of 24     babies less than 31 weeks gestation and who are less than 7 days old.   "
214386|NCT00649974|"     The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir     hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a     single, oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.   "
214387|NCT00649987|"     The objective of this study was to investigate the bioequivalence of Mylan's albuterol     sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single,     oral 8 mg (1 x 8 mg) dose administered under fed conditions.   "
214388|NCT00650000|"     The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg     tablets to Cephalon Provigil® 200 mg tablets following a single, oral 200 mg (1 x 200 mg)     dose administration under fasting conditions.   "
214389|NCT00650013|"     The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5     mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose     administration under fed conditions.   "
214390|NCT00650026|"     Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody     Adalimumab in Subjects with Active Rheumatoid Arthritis   "
214391|NCT00650039|"     The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and     valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain     after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary     objectives were to compare each valdecoxib dose with placebo on additional measures of pain     intensity, health outcomes, the use of rescue medication, and the occurrence of     opioid-related symptoms, and to evaluate their safety.   "
214392|NCT00650052|"     The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100     mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg)     dose administered under fasting conditions.   "
214393|NCT00650065|"     The objective of this study was to investigate the bioequivalence of Mylan cetirizine HCl 10     mg tablets to Pfizer's Zyrtec® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose     administration under fasting conditions.   "
214394|NCT00650078|"     The purpose of the study is to compare the safety and efficacy, with regards to the signs and     symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease     Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.   "
214395|NCT00650091|"     Idiopathic pulmonary fibrosis (IPF) is a long-term lung disease that affects an individual's     ability to breathe. In this randomized, double-blind, placebo-controlled trial, we assigned     patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment     to one of three groups — receiving a combination of prednisone, azathioprine, and NAC     (combination therapy), NAC alone, or placebo — in a 1:1:1 ratio.   "
214396|NCT00650104|"     The purpose of this study is to obtain information on the long-term safety, tolerability, and     therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for     patients who participated in either Study 167 or Study 164 to continue receiving ropinirole     XL if they chose to do so.   "
214397|NCT00650117|"     The objective of this study was to investigate the effect of three different types of     occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h     manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25     mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation. The acute irritation of     each type of overlay worn with each fentanyl treatment was also assessed after patch removal.   "
214398|NCT00650130|"     The aim of this study is to get new information on the whole blood-plasma-oral fluid ratios     of psychoactive drugs which are encountered in traffic.      Samples are taken from drivers suspected of being under the influence of drugs or medicines.     The samples are analysed with immunological methods and GC-MS.      Observations from Police and a physician on impairment are combined with the results of the     different bodily fluids. Observational evaluations and substance concentrations are compared.   "
214399|NCT00650143|"     Trial design:      This Phase III, investigator-driven, randomised, placebo-controlled efficacy and safety study     will compare the effects of Sitagliptin in combination with granulocyte-colony stimulating     factor (Lenograstim, G-CSF) on the improvement of myocardial function in patients undergoing     routine percutaneous coronary revascularisation for acute myocardial infarction (time from     onset of infarction to intervention 2 to 24 hours). The primary objective of this study is to     compare between a treatment of G-CSF plus Sitagliptin, (G-CSF/Sitagliptin treatment group,     n=87) versus Placebo (control treatment group, n=87) in change of global myocardial function     from baseline to 6 months of follow-up.   "
214400|NCT00650156|"     Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid     Arthritis   "
214401|NCT00650169|"     The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel     bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a     single, oral 75 mg (1 x 75 mg) dose administered under fed conditions.   "
214402|NCT00650182|"     The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl     system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.   "
214403|NCT00650195|"     The objective of this study was to investigate the bioequivalence of Mylan metolazone 10 mg     tablets to Celltech Zaroxolyn® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose     administration under fasting conditions.   "
214404|NCT00650208|"     The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25     mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg     (2 x 25 mg) dose administration under fasting conditions.   "
214457|NCT00658008|"     This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects,     ages from 18 to 65, with generalized anxiety disorder.   "
214405|NCT00650221|"     The objective of this study was to compare the rate and extent of absorption of pravastatin     sodium from a test formulation of Pravastatin Sodium 80 mg Tablets versus the reference     Pravachol® 80 mg Tablets under fasting conditions.      Based on the results from this study, the two 80 mg pravastatin tablet formulations     demonstrated bioequivalence under the single-dose fasting conditions.   "
214406|NCT00650234|"     The objective of this study was to investigate the bioequivalence of Mylan's metformin     hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single,     oral 500 mg (1 x 500 mg) dose administered under fasting conditions.   "
214407|NCT00650247|"     The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan     succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1     x 100 mg) dose administered under fed conditions.   "
214408|NCT00650260|"     Hypothermia is a common and serious complication during anesthesia and surgery.     Anesthetic-induced hypothermia results from the inhibition of thermoregulatory control and     exposure to cold operating room environment.      Various warming methods, such as warm blankets, forced-air warmers and circulating water     mattresses, are currently used to prevent and treat mild perioperative hypothermia. All are     cutaneous approaches that rely on heating the peripheral tissues in order to increase the     thermal core temperature. Application of cutaneous warming system blankets/pads are limited     by location/extent of operative site; for example, in certain procedures such as     laparatomies, reconstructive plastic surgery or orthopedic surgery, only a limited amount of     skin surface is available for warming application. The Dynatherm vitalHEAT technology takes     advantage of the body's natural thermoregulatory system to channel thermal energy to the     body's core non-invasively at a rapid rate. The vital heat (vH2) system is designed to treat     hypothermia during the peri-operative period through a combination of localized heat and     vacuum application to one hand & forearm; this application 1) opens the arteriovenous     anastamoses located in the palm of the hand and 2) conductively warms the extremity thus     effectively warming the blood flow to the body's core. The vital heat vH2 system is a     portable and compact warming device which provides a non-invasive approach to warming     patients during surgery.      The primary objective of this study is to determine if the Dynatherm Medical vitalHEAT (vH2)     Temperature Management System is as effective as the forced-air warming Bair Hugger™ (Arizant     Healthcare, Eden Prairie, MN) for maintenance of intraoperative body temperature in patients     undergoing abdominal surgery under general anesthesia. The critical endpoints to be evaluated     in making this determination are 1) % of subjects with an average intraoperative esophageal     temperature of ≥ 36º C and 2) % of subjects with an initial post anesthesia care unit     sublingual temperature of ≥ 36º C. Secondary objectives include 1) comparison of the core     body temperatures @ 60 minutes post anesthesia induction, 2) comparison of temperature trends     during surgery and 3) comparison of the subjects' post anesthesia care unit temperature     trends and hypothermic symptoms such as shivering.   "
214409|NCT00650273|"     The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600     mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg)     dose administered under fasting conditions.   "
214410|NCT00650286|"     The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg     tablets to Cephalon Provigil® 200 mg tablets following a single, oral 200 mg (1 x 200 mg)     dose administration under fed conditions.   "
214411|NCT00650299|"     The objective of this study was to investigate the bioequivalence of Mylan's alprazolam     Extended-release 3 mg tablets to Pharmacia & Upjohn's Xanax XR® 3 mg tablets following a     single, oral 3 mg (1 x 3 mg) dose administered under fed conditions.   "
214412|NCT00650312|"     The objective of this study is to investigate the bioequivalence of Mylan metformin     hydrochloride ER tablets to Glucophage® XR tablets following a single, oral 500 mg (1 x 500     mg) dose administration under fasting conditions.   "
214413|NCT00650325|"     The objective of this study was to investigate the bioequivalence of Mylan's sertraline     hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100     mg (1 x 100 mg) dose administered under fasting conditions.   "
214414|NCT00656877|"     The study to determine the if the incidence of Fat Embolism is decreased using Computer     Assisted technology when performing a Total Knee Arthroplasty.   "
214415|NCT00656890|"     The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen     in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in     patients administered MDX-1100.   "
214416|NCT00656903|"     This study will use an eye imaging test called high speed indocyanine green angiography     (HS-ICG), which examines leaky vessels in the eye, to try to find out why individuals respond     differently to ranibizumab (Lucentis) treatment for wet age-related macular degeneration     (AMD). The drug was recently approved by the Food and Drug Administration to treat this     disease, but the response to the treatment varies markedly among individuals.      People 50 years of age and older with wet AMD and vision that meets the research protocol     criteria may be eligible for this study. Participants undergo the following procedures:      Ranibizumab injections in the study eye once a month for 4 months. Additional injections are     given only if the study eye shows signs of bleeding or leaking fluid. The eye is numbed     before the injection and the eye area is cleaned with an antiseptic. Antibiotic drops are     used for 3 days following the injection to prevent infection.      Clinic visits once a month for 2 years for evaluations to monitor the response to treatment.     The evaluations may include the following examinations and tests:        -  Eye examination with dilation, optical coherence tomography and photography: The          examination measures visual acuity, thickness of your retina (the back of the eye)          andeye pressure. Bright lights will also be used so that the doctor can see the back of          your eye. Photographs of the eye may be taken.        -  Fluorescein angiography to examine the blood vessels in the eye: A dye called          fluorescein is injected into a vein in the arm. The dye travels through the veins to the          blood vessels in the eyes. A camera takes pictures of the dye as it flows through the          blood vessels. This test is done eight times during the study.        -  Indocyanine green angiography to examine the blood vessels in the eye: The procedure is          the same as for fluorescein angiography, but it uses a dye called indocyanine green.          This test is done once a month for the first year of the study and then every 3 months.   "
214417|NCT00656916|"     The goal of this clinical research study is to compare lung function of patients who inhale     steroids in the early stages of post-transplant constrictive bronchiolitis (PTCB) to patients     who continue with standard of care.   "
214502|NCT00658606|"     Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic     plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic     subjects as both modalities have an effect on T cells   "
214418|NCT00656929|"     Background: Vitamin D has been shown to be an important immune system regulator. Vitamin D     insufficiency during the winter may cause increased susceptibility to infections,     particularly viral upper respiratory tract infections (URIs).      Objective: To determine whether vitamin D supplementation during the winter season prevents     or decreases URI symptoms in adults.      Methods: A randomized, double-blind, placebo-controlled trial was conducted in 162 adults.     Participants were randomized to receive vitamin D3 50 mcg (2000 IU) daily or matching placebo     for 12 weeks from December 2006 to March 2007. A biweekly questionnaire was used to record     the incidence and severity of URI symptoms   "
214419|NCT00656942|"     The MGH Center for Translational Pain Research is seeking patients with chronic pain for a     research study. The study is looking at the effect of opioid (narcotic) pain medicines on     pain sensation, threshold and tolerance.   "
217223|NCT00697528|"     Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation     forms and stages, made with Color Doppler Imaging   "
214421|NCT00656968|"     Helicobacter pylori is a bacteria that infects the lining of the stomach and is associated     with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain     forms of gastric cancer. Curing this infection generally requires that patients take 2 or     more antibiotic medications and a stomach acid suppressing medication for about two weeks.     Current treatments do not always cure the infection and a new treatment is being tested in     this study. The drugs involved in the new 4 drug treatment have been widely used for     treatment of this infection. It remains unknown what is the best and most cost effective way     to give them. This study will compare three different ways of using these drugs.      Subjects must have active Helicobacter pylori infection in order to participate in this     study.   "
214422|NCT00656981|"     The objectives of this study were to evaluate the efficacy and safety of drospirenone 3     mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with     moderate acne vulgaris during 6 treatment cycles   "
214423|NCT00656994|"     The purpose of this study is to determine the long-term effects of Ramelteon, once daily     (QD), on endocrine function values.   "
214424|NCT00657007|"     The purpose of thie study is to evaluate the safety, tolerability, immunogenicity,     pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.   "
214425|NCT00657020|"     A single center, double blind, randomized, placebo controlled, two-treatments, two-period     crossover study conducted in adult smokers.   "
214426|NCT00657033|"     Study to investigate the efficacy and safety of vardenafil flexible dose versus placebo in     males with erectile dysfunction, and their female partners' sexual quality of life.   "
214427|NCT00657046|"     In clinical trials in Japan, droxidopa has been shown to be effective in affecting blood     pressure changes upon orthostatic challenge in patients with autonomic dysfunction, as well     as reducing the severity and frequency of symptoms of orthostatic hypotension in these     patients. The efficacy of droxidopa in ameliorating symptoms in patients undergoing dialysis     has also been demonstrated in the literature and clinical trials conducted in Japan. The     current study will investigate the clinical efficacy of two different doses of droxidopa in     patients with intradialytic hypotension over a 4 week treatment period with a placebo     control. The clinical efficacy will be evaluated by changes in hypotension- related symptoms,     as well as changes in blood pressure prior to, during and following, HD sessions as compared     to their pre-treatment baseline values.   "
214428|NCT00657059|"     A multi-center, randomized, controlled clinical trial to evaluate the short-term and     long-term efficacy and safety of mycophenolate mofetil (MMF) in reducing proteinuria and     preserving renal function in patients with IgAN who have pre-treated (and continue to be     treated) with angiotensin II receptor blockers (ARB), compared to the corticosteroids.   "
214429|NCT00657072|"     Damage to the ligaments of the wrist occurs frequently, however, it is not well publicized or     understood. Our previous and current biomechanical studies have shown that damage to certain     wrist ligaments is the likely cause of wrist instability and pain. Based on our three     dimensional models and animations of actual cadaver motions with various ligaments intact or     sectioned, we have identified several changes in how the carpal bones move and are positioned     relative to the radius with various levels of instability. Using this information, we have     developed a mathematical model that can predict in cadaver wrists which groups of ligaments     have been injured. We started, under IRB approval, a prospective clinical study to evaluate     the reliability of this mathematical model. During the past 5 years we have studied 13     patients with suspected wrist ligament injuries who were previously scheduled for surgical     treatment. CT scans have been performed of the injured wrist and for comparison purposes, the     contralateral, uninjured wrist. During these 5 years, there were no problems with the conduct     of the study. During these 5 years the only changes to the original study application were        -  a) to include a CT scan of the contralateral wrist for comparison purposes        -  b) a paper handout given to potential subjects        -  c) to add additional people to the study team.      The principal investigator, blinded to the results of the CT scan, surgically explores and     treats these patients in the same manner that he would for any patient with suspected wrist     ligament injuries. During the surgery, the investigator determines the integrity of the     various wrist ligaments. The prediction of which ligaments are damaged, based upon the CT     scan information and mathematical model is compared to the actual surgical findings. The     importance of this study is to develop a tool that will allow one to rapidly and non     invasively diagnose wrist instability and initiate treatment before further damage is done.   "
214430|NCT00657085|"     To observe the qualitative comparison of follicular damage between treatment with the     LightSheer Duet hand pieces (ET and HS) as assessed by horizontal biopsy.   "
214431|NCT00657098|"     Angiogenesis inhibitors and EGFR inhibitors not only have anti tumor activity but also modify     physiological processes. This study evaluates effects on vascular function, endocrine     function and metabolism. Changes in these parameters will be analysed for predictive value     for treatment efficacy.   "
214564|NCT00659425|"     To estimate maximum cummulative dose (MTCD) of CAT-8015 that can be safely administered to a     patient.   "
214955|NCT00657475|"     The purpose of this study is to demonstrate superiority on postoperative bleeding from the     use of a heparin half dose compared to a conventional dose, under mini-extra corporeal     circulation, without increased risk to the patient.   "
214432|NCT00657111|"     The purpose of this study is to test the safety and tolerability of an investigational     inhaled flu medication, CS-8958. Study participants will include 38 elderly males and     females, age 65 and older. Participants will be divided into 1 of 4 possible treatment groups     (Groups A, B, C and D) to receive the study drug or placebo (substance containing no     medication). Group A will receive 5 mg CS-8958, Group B will receive 10 mg CS-8958, Group C     will receive 20 mg CS-8958 and Group D will receive 40mg CS-8958. Safety information will be     reviewed prior to administering a higher dose of treatment. Study procedures will include     blood and urine samples, ECGs (measure of heart activity), and a 7 day clinic stay.     Participants will be involved in study related procedures for up to 6 weeks.   "
214433|NCT00657124|"     To elucidate the effect of preoperative supplementation of carbohydrate and branched-chain     amino acids on postoperative insulin resistance in patients undergoing hepatic resection, we     set a randomized trial.   "
214434|NCT00657137|"     This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with     placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate     urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate     selection criterion for patients who will benefit from future treatment with apricoxib.   "
214435|NCT00657150|"     The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral     dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily.     Safety and efficacy will be compared between the treatment groups.   "
217224|NCT00697541|"     Phase II systemic bioavailability crossover study to measure the exposure of Col-118 topical     0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2%   "
214436|NCT00657163|"     Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no     treatment able to enhance recovery has yet been validated. Some drugs may have a positive     effect when combined with physical rehabilitation. Previous studies have shown a potential     effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our     group has demonstrated in a small group of stroke patients (n=8) that a single dose of     fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and     modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind,     randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin     (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic     stroke.   "
214437|NCT00657176|"     This is an open-label, non-randomized, single-center, dose-escalation study in patients with     advanced solid tumors. Six dose levels (100, 200, 400, 600, 800, and 1000 mg/day) are planned     for the study. In this study, OPB-31121's potential for toxic effects will be evaluated in     patients with advanced solid tumors to evaluate the recommended dose for use in subsequent     studies. The pharmacokinetics and antitumor effect of the compound will also be investigated.   "
214438|NCT00657189|"     The primary objective of this study is to evaluate the safety and tolerability of multiple     doses of MEDI-545 in subjects with moderately to severely active Lupus.   "
214439|NCT00657202|"     The purpose of this research study is to determine if ranibizumab can prevent the growth of     neurofibromas. We will also be collecting extra blood and serum samples to help us learn more     about NF1. Ranibizumab is a drug that affects the development of blood vessels that feed     tumors. It targets a substance in the body called VEGF (Vascular Endothelial Growth Factor).     VEGF helps tumors to grow and survive by supporting the growth of blood vessels that bring     nutrients to the tumor. VEGF is made by cancerous tumors and also by non-cancerous tumors     such as neurofibromas.   "
214440|NCT00657787|"     The overall objective of this project is to develop the first longitudinal registry of     combat-exposed men and women with PTSD. This registry will provide essential data on the     natural history, including progression and remission, and outcomes associated with PTSD in     military service men and women who have utilized the Department of Veterans Affairs (VA)     health care system. Additional goals of this project are to determine risk factors for PTSD     among combat-exposed service men and women (by incorporating a combat-exposed non-PTSD group     of veterans into analyses), and to assess the joint effects of combat exposure and PTSD on a     broad range of outcome measures (by incorporating a non-combat-exposed group of veterans into     analyses). Thus, the registry will allow an evaluation of current theoretical models of     symptom development and progression in a large sample of service men and women who utilize     the VA medical system.      In addition to the PTSD registry, we will collect information on two comparison groups of     OIF/OEF-era veterans to conduct nested case control studies within the general VA health care     utilization database. First, a comparison group of combat veterans who are high utilizers of     VA medical care, but who have not received a diagnosis of PTSD will be identified. This group     will be used in analyses to identify risk factors for PTSD. Additionally, the rate of PTSD     symptoms will be evaluated in this comparison group to estimate the prevalence of missed PTSD     diagnoses among combat veterans with high rates of service utilization, and the resulting     impact on utilization and outcomes. A second comparison group will consist of veterans with     similar service record and demographic backgrounds, who were not deployed to the OIF/OEF war     zones. Thus, the proposed project will create a PTSD registry from the VA database to assess     the natural history and progression of PTSD in combat veterans from OIF/OEF and also to     conduct case-control studies nested within the VA database. The case-control comparisons will     be used to evaluate key hypotheses related to the specific aims of the overall project.   "
214441|NCT00657800|"     Patients will be recruited from comparable inpatient units that have been randomized as     either interventional (Group 1) or control (Group 2) units. Patients in the interventional     group will receive a comprehensive individualized diabetes education program coordinated by a     certified diabetes educator. Patients in Group 2 will receive education from clinical staff     as it is typically provided. Assessment of patient satisfaction with both inpatient and     outpatient care, quality of life, and diabetes self-management skills (including emergency     room visits and readmissions) will be measured using surveys completed during hospitalization     and 4 months after discharge to determine any differences between the two groups.   "
214442|NCT00657813|"     The main objectives of this proposal are as follows:      To assess the dynamic uptake and washout of 123-I MNI-330, a potential imaging biomarker for     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in     similarly aged Alzheimer's (AD) subjects and healthy controls      To perform blood metabolite characterization of 123-I MNI-330 in healthy and AD subjects to     determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-330 as a     single photon computed tomography (SPECT) brain imaging agent      Evaluate the test/retest reproducibility of 123-I MNI-330 and SPECT in AD subjects and     healthy controls   "
214483|NCT00658346|"     Infections with HIV-1 group O are found in 1 to 3 % of persons living with HIV in Cameroon.     The natural history and treatment response is not well understood. The natural resistance to     non nucleoside reverse transcriptase inhibitors and their possible low sensitivity to     protease inhibitors complicate the choice of an adequate treatment options.      This observational study is aimed at evaluating the antiretroviral treatment response of     HIV-1 group O infected patients in comparison with HIV-1 group M infected patients. The     proposed standardized follow-up will facilitate a better understanding of the natural history     and treatment specificities to improve the patients management.      This is a non randomized study, open label, with standardized follow-up. A total of 171     patients   "
214443|NCT00657826|"     The initial clinical investigation titled ATS 3f(r) Aortic Bioprosthesis Model 1000 Study,     was a prospective, non-randomized, multi-center study designed to evaluate the the safety and     effectiveness obtained from 800 patient years using a common clinical protocol. Twenty-three     (23) sites internationally and in the United States combined enrolled 405 patients. The     objective of the study was to evaluate the safety and effectiveness of the ATS 3f(r) Aortic     Bioprosthesis Model 1000 equine pericardial prosthesis in a a patient population undergoing     isolated aortic valve replacement of his / her native aortic valve, or replacement of a     failed prosthesis with or without concomitant procedures.      Addendum: After receiving PMA approval in October of 2008 of the 21mm-29mm sizes, this IDE     was expanded to comply with the conditions set forth in the approval notice. Study Protocol     S2001 Rev. E is a continuation of the original protocol, but is only enrolling subjects who     require a 19mm ATS 3f(r) Aortic Bioprosthesis, Model 1000 and is described as A     multi-center, non-randomized trial, designed to obtain 800 patient years. Each enrolled     patient will be followed for a minimum one year and annually thereafter until size 19mm     product approval or study cessation. Preoperative, discharge or 30 days (which ever comes     last), 3-6 month, and annual follow-up data are required.   "
214444|NCT00657839|"     Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign     Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve     the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily     administration of 10 mg BID.   "
214446|NCT00657865|"     This project investigates the effect of ACE-inhibition on cellular metabolism by gene     expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril     intake.      This should contribute to our understanding of the pathomechanisms involved in diabetes and     the clinical effect of ACE-inhibition on patients with diabetes/metabolic syndrome.   "
214447|NCT00657878|"     This study aims to test the hypothesis that the artificial prolongation of the platinum-free     interval with a non-platinum treatment will improve the effectiveness of overall therapy in     patients with ovarian cancer progression occurring 6-12 months after first-line treatment     with a platinum-derivative.   "
214448|NCT00657891|"     We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood     tests will be done in a test tube to see if they react differently before and after     treatment. The blood cells will be mixed with to whatever the person is allergic.   "
214449|NCT00657904|"     The purpose of this trial is to study the effect - in terms of time to progression and     overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in     subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the     prostate gland.   "
214450|NCT00657917|"     The primary objective of this protocol is to treat laboratory confirmed cutaneous     leishmaniasis with WR 279,396 in military health care beneficiaries. In this study cutaneous     leishmaniasis is defined as Old World Leishmaniasis if acquired in the Southwest Central     Asia/Middle East.   "
214451|NCT00657930|"     This study is conducted in Europe. The aim of this observational study is to gain practical     experience with once-daily Levemir administration in type 2 diabetes patients who were     previously treated with Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of     their ICT under normal clinical practice conditions in Hungary.   "
214452|NCT00657943|"     Type 2 Diabetes Mellitus patients (T2DM) have an increased mortality rate due to     macrovascular disease. The primary objective of the study is to evaluate the effect of an     18-month treatment with metformin versus placebo in combination with one of three insulin     analogue regimens following a treat-to-target principle. The primary outcome measure is     change in wall thickness of the carotic arteries(CIMT)measured by ultrasound. A total of 900     patients with T2DM and HbA1c above 7.5% will be included.   "
214453|NCT00657956|"     Hip and knee replacement arthroplasty are profoundly successful operative interventions,     however, some joint replacements do fail and the life expectancy of a hip or knee     arthroplasty is finite. This fact has largely been responsible for the continued development     of new devices and techniques for joint arthroplasty surgery. Unfortunately, the introduction     of new technologies and devices is not a benign process, and even subtle changes to existing     implants can have a disastrous effect on patient outcome. The fact that new technologies and     devices can lead to poor results has led some authors to advocate a phased introduction of     new technologies. A key component of the phased introduction approach advocates the use of     roentgen stereophotogrammetric analysis (RSA) early in the testing process. RSA is a highly     accurate radiographic technique developed in Lund, Sweden and has for some time been the gold     standard in Europe for assessing the stability of implants within bone. The purpose of this     study is to utilize RSA to elucidate the migration patterns of the foam metal backed Advance     Knee Arthroplasty components during the first 2 years postoperatively and to determine in     what proportion of cases adequate fixation is achieved. In addition outcome measures will be     recorded to quantify changes in functional status of subjects after surgery and bone mineral     density will be monitored to quantify bone in-growth around the implant. Migration patterns     will be compared to results obtained from previous studies of uncemented and cemented total     knee arthroplasty components conducted at this centre.   "
214454|NCT00657969|"     The main purpose of this study is to look for genetic and environmental risk factors of     cervical artery dissections, a major cause of ischemic stroke in young adults, in a large     multicenter case-control trial   "
214484|NCT00658359|"     This is a study that will follow transplant patients from Study A3921030 to monitor for long     term safety, tolerability and efficacy for 5 additional years, except in Portugal where the     study will follow transplant patients through Month 36 posttransplant. Patients will continue     their study medications that were previously assigned.   "
214485|NCT00658372|"     This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects,     ages 18 to 65, with generalized anxiety disorder.   "
216164|NCT00681109|"     The purpose of this study is to determine the effectiveness and safety of Topical     Interleukin-1-Receptor Antagonist in treatment of signs and symptoms of posterior     blepharitis.   "
214455|NCT00657982|"     The mechanisms responsible for the development of hormonal refractory prostate cancer (HRPC)     have been elusive. Genetic inactivation/loss of the PTEN tumor suppressor gene occurs in     30-60% of advanced prostate cancers and in 20% of the localized form. Researchers hypothesize     that PTEN loss is a landmark genetic event in prostate cancer progression into the fatal HRPC     form. One consequence of PTEN loss is activation of the oncogenic Akt and phosphorylation of     downstream Akt targets including mTOR. mTOR controls many important cellular processes     including cell cycle regulation.      We propose to evaluate pharmacodynamic assessments of the mTOR inhibitor RAD001 in     intermediate and high risk prostate cancer patients in the neoadjuvant setting. Patients will     be admitted to 6 weeks treatment with RAD001 10 mg/day followed by either radical     prostatectomy or radiotherapy combined with hormonal treatment. Immunohistochemistry with     antibodies for phosphorylated p70S6K , pS6, Akt as well as antibodies for VEGF, BCL2 and PTEN     in prostate cancer tissues before and after 6 weeks RAD001 treatment will be performed.     Additionally, Patients will be evaluated by FDG-PET scan before (as baseline) and after     RAD001 treatment. A link between mTOR signaling and glycolysis regulation was established and     may provide a mechanism to assess drug-target interaction of RAD001 in prostate cancer.      The secondary endpoint of the trial will be to determine the response proportion to RAD001     treatment by assessing time to biochemical failure followed by radiation therapy or radical     prostatectomy. The data will be compared to a matched cohort of high and intermediate-risk     prostate cancer patients admitted to the same treatments modalities without receiving RAD001.   "
214456|NCT00657995|"     This study evaluated a closed-loop system providing continuous monitoring and strict control     of perioperative blood glucose following pancreatic resection.   "
214458|NCT00658021|"     The primary objective of this study is to test the hypothesis that glycemic control, as     measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is     superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2     diabetes who are naïve to antidiabetes agents, or patients who are being treated with     metformin, an SU, or a combination of metformin and an SU.   "
214459|NCT00658034|"     This is a randomized, placebo controlled study in cancer patients reporting fatigue     persisting for at least two months following completion of chemotherapy. Subjects will     receive 6 weeks of either acupuncture or placebo treatment as a means of evaluating whether     acupuncture reduces chronic fatigue after chemotherapy.   "
214460|NCT00658047|"     The purpose of this trial is to assess the clinical effect of CH-1504 at doses of 0.25, 0.5     and 1.0 mg per day in patients with active rheumatoid arthritis by determining the proportion     of patients achieving an American College of Rheumatology (ACR) 20% improvement response.   "
214461|NCT00658060|"     Familial Mediterranean fever (FMF) is an inherited disorder of unknown etiology,     characterized by recurrent episodes of fever, peritonitis and/or pleuritis.      Fever is the cardinal manifestation of FMF and is present in most attacks accompanied by     abdominal pain.      Another clinical manifestation in patients with FMF is exertional muscle pain, usually in the     thigh, which appears even after minor exercise or physical activity in young patients with     generally good health (other than FMF) and in good physical condition. Some patients also     complain of ankle edema after relatively minor physical activity, which subsides after a     night rest. Although these manifestations are quite common in FMF patients and form part of     the minor criteria for the diagnosis, the etiopathogenesis has not been examined.      The purpose of the suggested study is to evaluate and characterize the anatomical and     biochemical changes in the muscles of the thigh and in the ankle triggered by physical     activity in FMF patients complaining of exertional lower leg myalgias and edema after minor     physical exercise.   "
214462|NCT00658073|"     The goal of this study is to evaluate autologous MSCs as an alternative for antibody     induction therapy in renal transplantation.   "
214463|NCT00658086|"     To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected     lung transplant patients   "
214464|NCT00658099|"     This trial is conducted in Europe. The aim of this observational study is to evaluate the     change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal     clinical practice conditions.   "
214465|NCT00658112|"     The purpose of this research study is to see how often benzoyl peroxide is applied for acne.     Use of medication was monitored electronically.   "
214466|NCT00658125|"     Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75     million people in the US and Canada. People with AD have difficulty remembering general facts     and previously experienced autobiographical events. Animal and human research demonstrates     that this type of memory depends on neural function within specific brain areas, and that it     may be possible to enhance memory with electrical stimulation of these brain areas. We have     recently shown that deep brain stimulation (DBS) of a brain area called the fornix enhances     memory in a human.      Hypotheses: We hypothesize that fornix DBS will safely enhance memory in early AD patients by     activating memory circuits in the brain.      Methods: Six early AD patients will take part in a phase I clinical study over a 1-year     period. The study involves bilateral fornix DBS implantation, detailed neuropsychological and     neurological testing, and brain imaging to detect alterations in brain activity induced by     stimulation. These assessments will occur one month before surgery, then again at one month,     6 months, and 12 months after surgery.   "
214467|NCT00658138|"     The purpose of this study is to evaluate the performance of a new dental adhesive system in     the restoration of Class I and Class II cavities in adult teeth.   "
214468|NCT00658151|"     The hypothesis is that there are unique sonographic characteristics of antibiotic-associated     diarrhea. We will compare the ultrasound findings in patients who received antibiotics and     developed diarrhea to toxin analysis for clostridium difficile in stool in order to find     differences in the sonographic findings in the positive and negative cases.   "
214499|NCT00658567|"     This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103)     compared to placebo in patients with Parkinson's disease psychosis.   "
214500|NCT00658580|"     The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival     in comparison to a regimen containing etoposide and without platinum derivative.   "
214469|NCT00658164|"     Patients will be randomized to lifestyle changes alone or lifestyle changes associated with     iron depletion.      Iron depletion will be achieved by removing 350 cc of blood every 10-15 days according to     baseline hemoglobin values and venesection tolerance, until ferritin < 30 ng/ml and     transferrin saturation < 25%. Weekly phlebotomies will be allowed for carriers of the C282Y     HFE mutation. Smaller phlebotomies (250 cc) will be allowed for carriers of beta-thalassaemia     trait. Maintenance phlebotomies (as much as required) will then be instituted to keep iron     stores depleted (ferritin < 50 ng/ml and transferrin saturation < 25%, MCV <85 fl). Before     starting treatment, patients will undergo ECG, and in the presence of hyperglycemia or     hypertension also echocardiography (see exclusion criteria).      Change in diabetes medication dosage or start of new therapy will be allowed for HbA1C values     <6% or ≥ 7%. According to accepted criteria, previously untreated patients should be treated     with metformin. If possible, newly diagnosed hypertension should be treated with     Ace-inhibitors.   "
214470|NCT00658177|"     Study to investigate the efficacy and safety of Vardenafil   "
214471|NCT00658190|"     The purpose of this study is to assess whether a system that couples automated screening of     Pap Tests with transmission of machine selected digital images, and review by cytologists at     a remote location, performs to a clinically effective standard of accuracy.   "
214472|NCT00658203|"     The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT)     achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical     procedure.      PEA optimised configuration (PEA-CRT) is obtained, during patient's follow-up, using the Peak     Endocardial Acceleration sensor features onboard the device.   "
214473|NCT00658216|"     The purpose of this study is to test the usefulness of measuring plasma brain natriuretic     peptide (BNP) for diagnosis and prognosis in very elderly dyspneic patients.   "
214474|NCT00658229|"     The purpose of this study is to determine the effectiveness of a four months strength     training program on physical and psychological health in patients with prostate cancer during     androgen deprivation therapy. It is hypothesized a beneficial effect of the intervention on     physical and psychological health in patients with prostate cancer treated with androgen     deprivation.   "
214475|NCT00658242|"     Craniofacial reconstruction procedures are undertaken in young children to improve     appearance, prevent functional disturbances, and enhance psychosocial development. These     procedures involve wide scalp dissections and multiple osteotomies and have been associated     with significant morbidity. The most commonly seen perioperative complications are associated     with the rate and extent of blood loss. This prospective observational registry will be a     research tool which will provide a means to evaluate perioperative management of these     children at CHOP.   "
214476|NCT00658255|"     The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort     with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.   "
214477|NCT00658268|"     The primary focus of this study is to investigate whether increased bone density of the graft     in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative     to the femur.   "
214478|NCT00658281|"     The goal of this clinical research study is to use the On Board Imager kilovoltage (OBI KV)     system and cone beam computed tomography (CBCT) scanning or CT-on-rail system to look at how     well a routine device called an electronic portal imaging device (EPID) can set up a patient     to receive radiation therapy on the lymph nodes in the neck.   "
214479|NCT00658294|"     The aim of this study is to evaluate PET-CT and EmII/3-10 serology as potential markers to     assess the parasitocidal effect of benzimidazoles        -  Trial with medicinal product   "
214480|NCT00658307|"     It has been suggested that the therapeutic effects of repetitive transcranial magnetic     stimulation (rTMS) are mediated through changes in cortical inhibition (CI). However, in     healthy subjects the effects of rTMS on CI have been inconsistent. The aim of this study is     to explore different rTMS - stimulus conditions neurophysiological and molecular mechanisms     in the human motor cortex. Fifty-six healthy subjects will be randomized into three different     treatment groups and receive 1 active or sham rTMS session (6000 rTMS pulses) at 90% of their     motor threshold (MT). Cortical inhibition will be indexed pre and post treatment using     short-interval intracortical inhibition (SICI), cortical silent period (CSP) and     long-interval cortical inhibition (LICI).      Based on previous studies we hypothesize that:        -  Hypothesis 1: rTMS will result in a greater CI (i.e., prolonged CSP, increased LICI but          not SICI) compared to sham rTMS.        -  Hypothesis 2: 20 Hz rTMS will result in a significantly greater CI compared to 1 Hz          rTMS.        -  Hypothesis 3: There will be distinctive transcription profiles associated with increases          in CI from rTMS that can be detected with whole-genome microarray analysis of peripheral          leukocytes.   "
214481|NCT00658320|"     The 12 Month Core Study (CRAD001A1202) was designed to evaluate the efficacy and safety     comparing concentration-controlled everolimus (1.5 mg/day starting dose) with reduced dose     cyclosporine and corticosteroids versus 2 g/day mycophenolate mofetil (MMF) with standard     dose cyclosporine and corticosteroids in de novo renal transplant recipients.      Extension Study (CRAD001A1202E1): Until 24 months after renal transplantation, the study was     designed to evaluate the long-term safety and efficacy comparing concentration-controlled     everolimus with reduced dose cyclosporine (Neoral®) and corticosteroids versus mycophenolate     mofetil with standard dose Neoral® and corticosteroids in de novo renal transplant     recipients. Beyond 24 months after renal transplantation, the study was designed to provide     everolimus treatment for patients in everolimus group until everolimus is approved and     marketed in Japan.   "
214482|NCT00658333|"     To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic     acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms   "
214501|NCT00658593|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. It is not yet known whether gemcitabine is more effective when given     together with or without capecitabine in treating patients with biliary cancer.      PURPOSE: This randomized phase III trial is studying giving gemcitabine together with     capecitabine to see how well it works compared with giving gemcitabine alone in treating     patients with locally advanced, unresectable, or metastatic biliary cancer.   "
214486|NCT00658385|"     Betathalassemia major is a disease of the blood and bone marrow. You were born with it and it     has made you unable to make normal hemoglobin and red cells. You have been receiving red     blood cell transfusions all your life. These transfusions do not cure your disease. The     problem with transfusions is that they contain a lot of iron. With time iron builds up in     your body and will eventually hurt some of your organs . Because of this buildup of iron ,     you are taking medicine that helps your body get rid of the extra iron.      Today, the only other treatment is bone marrow or stem cell transplant. It can only be done     when a matched donor is available. This is most often a brother, sister, or parent. Bone     marrow transplant may cure betathalassemia major. If you have a transplant and it is     successful, you will no longer have the disease. Without a matched sibling or parent, the     standard treatment is to keep having transfusions.      In the near future, we will be testing a new treatment for making normal hemoglobin and     normal red blood cells. We have recreated the healthy hemoglobin gene in a test tube. We are     able to use it and put it back into cells. This is called gene therapy. We have been able to     put this gene into the stem cells of mice with thalassemia. These mice were cured. We now     plan to take that gene and put it into stem cells from people who have betathalassemia major.     We will then inject those stem cells back into that person's blood.      In general, we can obtain more stem cells from the blood of a person than from the bone     marrow . In order to do so, we must give that person a blood growth factor. The growth factor     stimulates the bone marrow to make more stem cells. That growth factor is called granulocyte     colony stimulating factor (GCSF), or Filgrastim.      The purpose of this trial is to find out if the drug GCSF has any side effects on you, and if     you will make more stem cells in response to it. This trial is not a gene therapy trial. This     trial will not help your thalassemia.   "
214487|NCT00658398|"     The purpose of this study is to evaluate the effect of a brief computer program to prevent     alcohol misuse for patients consulting in an emergency department and screened for alcohol     misuse.   "
214488|NCT00658411|"     The objective of this research study is to determine the safety and feasibility of chelation     therapy with deferoxamine for patients with iron overload who are receiving a stem cell     transplant. Patients who have iron overload prior to stem cell transplantation may have more     toxicity from the transplantation procedure, and thus may benefit from an attempt at iron     chelation pre- and peri-transplantation. In this study we are examining the use of     deferoxamine starting 2 weeks to 3 months prior to transplantation and continuing through the     preparative regimen.   "
218905|NCT00716443|"     Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane®     injections for the correction of nasolabial folds.   "
214489|NCT00658437|"     The trial is designed as a phase II evaluation of the effect of CY-503 on progression free     survival (PFS) in patients with stage IV malignant melanoma after failure of prior therapy.     The aim of the study is at least a rate of 25% (PFS >/= 3 months).   "
214490|NCT00658450|"     The purpose of this study is to determine whether computerised cognitive rehabilitation     training improves cognition in children who have had cerebral malaria.   "
214491|NCT00658463|"     Statins have been shown to reduce significantly the risk for cardiovascular events in     patients with type 2 diabetes and statin therapy is largely recommended in this high     cardiovascular risk population. However, a residual cardiovascular risk is observed in     patients with type 2 diabetes treated by statins. This may be due to the fact that statins do     not correct all lipid abnormalities associated with diabetic dyslipidaemia, such as hyperTG     and low HDL-cholesterol.      Rosuvastatin is a statin which, in addition to its efficacy to reduce LDL-cholesterol, has     been show to decrease significantly plasma triglycerides. However, the effects of     rosuvastatin on triglyceride rich lipoproteins and HDL remains unknown. The purpose of this     study is to analyze the effect rosuvastatin 20 mg on the metabolism of triglyceride rich     lipoproteins and HDL in patients with Type 2 diabetes using and in vivo kinetic study of     VLDL1-apoB,VLDL2-apoB,IDL-apoB and HDL-apoA1.   "
214492|NCT00658476|"     Adolescence is the highest risk period for depression onset. More than 1.3 million youths     suffer from major depression annually in the United States, and there is evidence for an     increasing trend. Because many adolescents have their first depressive episode in adolescence     and adolescent depression often leads to recurrent mood disorders in adults, effective     treatment during early illness can minimize the negative consequences of initial and repeated     episodes. Although some antidepressants (particularly Selective serotonin reuptake inhibitors     (SSRIs)) are effective treatments for juvenile depression, recent warnings about suicide and     the use of SSRls highlight the need for new and safe treatment for juvenile depression. Data     in adults suggest that supplementation with polyunsaturated fatty acids (PUFA) might be     useful for the treatment of depression. The purpose of this study is to investigate the     safety and efficacy of PUFA for the treatment of adolescent depression.   "
214493|NCT00658489|"     The purpose of Bright Futures is to promote and improve infant, child, and adolescent     health within the context of family and community. CORNET (COntinuity Research NETwork of the     Ambulatory Pediatric Association) is a national practice-based research network of resident     continuity practices, whose mission is to establish a self-sustaining collaborative research     network among pediatric continuing clinic clinicians who will produce quality research in     primary care, health care delivery, and education.   "
214494|NCT00658502|"     Our study has three parts has three parts, and the main aim of the study is to find out if     corneal hysteresis was associated with myopia or even a predictor of myopia poor control     predictor:        -  Part 1 of our study: patients with anisomeropia whose spherical equivalent refraction as          measured by cycloplegic autorefraction between the two eyes differ greater than 1.5 D.        -  Part 2 of our study: Minus spherical equivalent refraction as measured by cycloplegic          autorefraction.        -  Part 3 of our study: patients with minus spherical equivalent refraction as measured by          cycloplegic autorefraction who are under regular atropine for the treatment of          myopia;patients who are prescribed with atropine treatment are in need of myopia control          instead of for research interest   "
214495|NCT00658515|"     This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and     mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS)     and evaluate the long term safety profile of the drug. Eligible patients in stable condition     will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a     background of standard medication for ACS (including aspirin, antihypertensives and statins).     The anticipated time on study treatment is 2+ years, and the target sample size is 15,600     individuals.   "
214496|NCT00658528|"     The purpose of this study is to determine the safety and efficacy of Rabeprazole extended     release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among     subjects with erosive gastroesophageal reflux disease (GERD).   "
214497|NCT00658541|"     The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem     tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem     tartrate tablets)in adult subjects under fed conditions.   "
214498|NCT00658554|"     This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal     healthy volunteers using a randomized crossover design.   "
214503|NCT00658619|"     Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal     implant. Patients will receive implant in one eye and sham treatment (meaning no treatment)     in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1.     Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the     safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy     from age-related macular degeneration. Patients will be followed for up to 2 years.   "
214504|NCT00658632|"     The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB)     Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive     gastroesophageal reflux disease (eGERD).   "
214505|NCT00658645|"     The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance     phase of schizophrenia compared to placebo.   "
214506|NCT00658658|"     The primary objective of this study was to evaluate the safety and pharmacokinetics of up to     3 different dose schedules of panitumumab in pediatric patients with solid tumors.   "
214507|NCT00658671|"     A dose-escalation trial designed to assess the safety and tolerability of treatment with     ENMD-2076 administered orally over a range of doses in patients with advanced cancer that is     refractory to current treatment or for which no curative therapy exists.   "
214508|NCT00658684|"     To assess the long term safety, tolerability and efficacy of fesoterodine in patients with     OAB.   "
214509|NCT00658697|"     In this research study, we aim to evaluate the feasibility, toxicity and efficacy of early     multimodality systemic therapy (a combination of docetaxe, bevacizumab, and androgen     deprivation therapy(ADT) in men with biochemical recurrence (BCR) or who have a rising     Prostate Specific Antigen (PSA) after treatment of their prostate cancer with surgery or     radiation)   "
214510|NCT00658710|"     The aim of this multi-center, randomized controlled study is to acquire and compare     information on gait performance in patients with chronic hemiplegia (six months to two years     post-stroke) who either continue to attend two physical therapy sessions per week for two     months or who stop physical therapy sessions for two months.Following the initial screening,     subjects will be randomized into two groups: one who continues attending two physical therapy     sessions per week for two months, or the other one who stops physical therapy sessions for     two months. Before and after those two months, a 3 days recording will be made using an     ambulatory system called TRIDENT.   "
214511|NCT00658723|"     The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to     SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft     tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.   "
214512|NCT00658736|"     This is a triple-blind, parallel group, randomized controlled trial to assess the benefit of     triamcinolone injection as a therapeutic measure for control of chronic pancreatitis pain.     The treatment group will undergo EUS-CPB with bupivicaine plus triamcinolone (therapeutic     block). There control group will undergo EUS-CPB with bupivicaine alone (diagnostic     block).   "
214513|NCT00658749|"     This is a phase one study to evaluate the safety, tolerability, and bioavailability of     nebulized AIR645.   "
214514|NCT00658762|"     This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects ages     18 and older with generalized anxiety disorder.   "
214515|NCT00658775|"     The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and     safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the     treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).   "
214516|NCT00658788|"     The primary objectives of this study are to evaluate the safety & efficacy of consecutive     treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.   "
214517|NCT00658801|"     The only curative option for pancreatic cancer patients is surgery, but the patients within     20% of them are possible for a radical surgery. Accordingly, concurrent chemo-radiation     therapy is generally used for palliation of unresectable pancreatic cancer patients. So far,     the use of 5-fluorouracil (5-FU) was the traditional method of chemotherapy. However, these     days, oral anti-cancer medicine, capecitabine(Xeloda®), was developed and considered as an     alternative medicine of 5-fluorouracil (5-FU). Furthermore, according to the recent results     of clinical trials, the clinical use of capecitabine(Xeloda®) with radiation therapy was     proved to be very effective and safe. Proton therapy is a new radiation therapy which     remaining energy is released when they reach the tumor, delivering the most effective dose of     radiation and which can minimize the exposure to normal tissues. The purpose of this trial is     to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.   "
214518|NCT00658814|"     This phase II trial is studying the side effects of giving azacitidine together with     gemtuzumab ozogamicin to see how well it works in treating older patients with previously     untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can     block cancer growth in different ways. Some block the ability of cancer cells to grow and     spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.   "
214519|NCT00658827|"     The purpose of this study is collection and analysis of information pertaining to pregnancy     outcomes in women exposed to infliximab during pregnancy, relative to the background risk in     similar but non-biologic exposed patients; and information pertaining to health status,     during the first year following delivery, of infants born to women following prenatal     exposure to infliximab and their unexposed counterparts.   "
214579|NCT00659620|"     Mesenchymal Stem Cell (MSC) have been shown to have immunosuppressive and repairing     properties. the investigators will infuse expanded MSC into patients who develop Chronic     Allograft Nephropathy. The purpose of this study is to find out MSC is more effective in     preventing organ rejection and maintaining kidney function.   "
214580|NCT00659633|"     The purpose of this study is to study if lidocaine, given intravenously, reduces pain.   "
214520|NCT00658840|"     The only curative option for pancreatic cancer patients is surgery, but the patients within     20% of them are possible for a radical surgery. Accordingly, concurrent chemo-radiation     therapy is generally used for palliation of unresectable pancreatic cancer patients. So far,     the use of 5-fluorouracil (5-FU) was the traditional method of chemotherapy. However, these     days, oral anti-cancer medicine, capecitabine(Xeloda®), was developed and considered as an     alternative medicine of 5-fluorouracil (5-FU). Furthermore, according to the recent results     of clinical trials, the clinical use of capecitabine(Xeloda®) with radiation therapy was     proved to be very effective and safe. The purpose of this trial is to improve the therapeutic     effects by using proton therapy and chemotherapy concurrently.   "
214521|NCT00658853|"     4 times 4 minutes interval training with and without hyperoxia is more effective than low     intensity endurance training.   "
214522|NCT00658866|"     Background/rationale: Ertapenem is an innovative antimicrobial agent, which is approved in     the European Union for diabetic foot infections of the skin and soft tissue. Although its     antimicrobial spectrum and activity against ESBL-strains are promising to treat infected     ulcers associated with diabetes, there is a lack of data on tissue pharmacokinetics of     ertapenem in this patient population. However, for antimicrobial efficacy it is important to     show that the antibiotic achieves sufficient concentrations at the site of infection, i.e. in     tissue. A recent clinical study by Burkhardt et al. (Journal of Antimicrobial Chemotherapy,     2006) using the microdialysis technique showed that the free tissue concentrations after a     single dose of 1 g ertapenem are sufficient and adequate to kill most relevant bacteria,     suggesting efficacy of ertapenem for soft tissue infections. It is well known that there is     no accumulation of ertapenem in plasma after multiple doses of 1 g every 24 h in patients     without significantly impaired renal function. The single dose study by Burkhardt et al. also     suggests that only negligible drug accumulation can be expected in soft tissues of healthy     young volunteers after multiple doses. However, it was shown for other antibiotics that     tissue PK may be significantly different under pathologic conditions, leading to impaired     penetration, but subsequent accumulation after multiple doses due to a longer tissue half     life than in healthy volunteers. Since the properties of inflamed tissue may diverge from     those of healthy tissue it is important to evaluate which concentrations of ertapenem are     reached in inflamed tissue after multiple doses.      Clinical study: In the present study we will measure the concentrations of ertapenem over     time in plasma and infected tissue of 10 diabetes patients after multiple doses. The     microdialysis technique will be used. The ertapenem concentrations will be measured in     inflamed tissue and in non-inflamed subcutaneous tissue to identify the effect of     inflammation on pharmacokinetics. The findings of the present study will help to confirm the     efficacy of ertapenem for the indication of diabetic soft tissue infections.   "
214523|NCT00658879|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
214524|NCT00658892|"     RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them.      PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal     antibody in treating patients with stage IV melanoma.   "
214525|NCT00658905|"     The purpose of this study is to evaluate the efficacy in preterm infants following treatment     with BSSL when administered in infant formula.   "
214526|NCT00658918|"     The primary objective of this study is to demonstrate the safety of three dose levels of     ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once     daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to measure     serum concentrations of ciclesonide and its active metabolite under steady state conditions     at three time points corresponding to the presumed peak and trough exposure after six weeks     of administration.      In addition, reflective (24-hour) total nasal symptom score (TNSS) over the six weeks of     treatment at various timepoints and a physician assessment of nasal symptoms at endpoint were     summarized.   "
214527|NCT00658931|"     The primary objective of this pilot project is to evaluate the efficacy of Cymbalta for     bereavement-associated depression. Participating patients will be treated with Cymbalta in     doses up to 60mg daily for eight (8) weeks. The primary outcome measure for this study will     be the 17-item Hamilton Rating Scale for Depression (HRSD-17). In pursuit of this objective,     we will test the following hypothesis: After eight weeks of open-label treatment with     Cymbalta for bereavement-associated depression, at least half of the participants will     achieve remission, as measured by a score of 7 or less on the HRSD-17.      Secondary objectives of this project are:        -  To determine the tolerability of Cymbalta treatment among patients with          bereavement-associated depression (as measured by adverse events and the proportion of          participants who discontinue Cymbalta before completing eight weeks of study treatment);        -  To determine the effect of Cymbalta treatment on grief in patients with          bereavement-associated depression (as measured by the Texas Revised Inventory of Grief          and the Inventory of Complicated Grief after eight weeks of treatment compared to          baseline); and        -  To determine the effect of Cymbalta treatment on health status, pain, and other          co-morbid symptoms in patients with bereavement-associated depression (as measured by          the Edmonton Symptom Assessment System and the Medical Outcomes Study 12-item Short Form          Health Survey administered at Weeks 2, 4, and 8 and compared to baseline).   "
214528|NCT00658944|"     To investigate the role of preoperative maximum urethral closure pressure and Valsalva leak     point pressure in predicting outcome in patients who underwent trans-obturator tape for the     treatment of female stress urinary incontinence.   "
214529|NCT00658957|"     The purpose of this study is to determine the safety and efficacy of the topical gentamicin     collagen sponge (gentamicin sponge) combined with standard of care (daily wound care,     off-loading, diabetic control and debridement by a physician or podiatrist), compared with     placebo sponge combined with standard of care, in preventing infection of diabetic lower     extremity skin ulcers.   "
214530|NCT00658970|"     The purpose of this Phase 1 study is to determine the safety and tolerability of KX2-391 in     cancer patients.   "
214531|NCT00658983|"     Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of     chronic lower leg ulcers.   "
214532|NCT00658996|"     Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily     Toric Contact Lens   "
214581|NCT00659646|"     The purpose of this study is to determine whether the gentamicin-collagen sponge when     combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and     effective in treating moderately infected skin ulcers compared to treatment only with     standard daily wound care and an oral antibiotic (levofloxacin).   "
214582|NCT00659659|"     Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of     MEDI-563 on eosinophil counts in airway mucosal biopsies   "
214533|NCT00659009|"     Ascent to altitude lowers oxygen saturation. In addition, sleep lowers oxygen saturation at     any altitude. In a prior study, we observed that sleep at 8000 feet resulted in pronounced     reduction in oxygen saturation, but did not result in reduced post sleep neurobehavioral     performance or impaired sleep quality or quantity. We plan to do a more sophisticated     physiological evaluation of the respiratory mechanisms responsible for the reduced oxygen     saturation and determine if there are any adverse consequences to this level of intermittent     hypoxia. We anticipate that central respiratory apnea is the physiologic mechanism, and that     there will not be persistent changes in autonomic nervous activity measured by heart rate     variability.   "
214542|NCT00659126|"     This phase II trial studies how well magnetic resonance imaging (MRI) using contrast imaging     agent ferumoxytol works in comparison to standard imaging agent gadolinium in measuring     tumors in patients undergoing treatment for brain tumors or other tumors that have spread to     the brain. Diagnostic procedures, such as MRI, may help find and diagnose disease and find     out how far the disease has spread. MRI scans use radio waves and a powerful magnet linked to     a computer to create detailed pictures of areas inside the body. The contrast imaging agent     ferumoxytol consists of small iron particles taken by the blood stream to the brain and to     the area of the tumor. It is highly visible on the MRI, and may help visualize the blood flow     going through the tumor better than gadolinium can. Using a more sensitive and faster 7 Tesla     (7T) magnet MRI in conjunction with a contrast imaging agent may provide a better way to     measure tumors than the 3 Tesla (3T) magnet MRI in patients with brain tumors.   "
214543|NCT00659152|"     Patients affected by acute lung injury-acute respiratory distress syndrome (ALI-ARDS) undergo     a positron emission tomography (PET) scan in order to analyse lung function.   "
214587|NCT00659724|"     The purpose of this study is to collect information on the ease of use and thrombogenicity of     the Polyflux HD-C4 Big and Fresenius Optiflux 180NR or 200NR dialyzers under conditions of     routine clinical use for hemodialysis.   "
214534|NCT00659022|"     Study Hypothesis      • As well as in animal models as in patients with colorectal cancer resection of the primary     tumor resulted in increase in vascular density, metabolism and secondary tumor growth of the     distant metastases. These data strongly suggest an inhibitory effect of the primary tumor on     the outgrowth of its metastases.      In this study we investigate whether pre-operative treatment with the anti-angiogenic agent     bevacizumab and/or chemotherapy before resection of the primary colorectal tumor shifts the     balance between angiogenic and anti-angiogenic factors in favor of the anti-angiogenic     factors and results in reduced growth of the liver metastases.      Eligibility        -  Histological proven colorectal cancer without signs of bowel obstruction or bleeding        -  Synchronous liver metastases        -  WHO performance status 0-1      Treatment        -  Arm A: immediate surgery of the primary colorectal tumor, no neoadjuvant therapy        -  Arm B: neoadjuvant treatment with bevacizumab during 7 weeks prior to surgery of the          colorectal primary        -  Arm C: neoadjuvant treatment with CAPOX during 7 weeks prior to surgery of the          colorectal primary        -  Arm D: neoadjuvant treatment with bevacizumab and CAPOX during 7 weeks prior to surgery          of the colorectal primary      Primary endpoint Difference in response of liver metastases to resection of the primary tumor     between the experimental groups and the control group, as determined by histopathological     scoring of vascular density, apoptotic and mitotic index and by measurement of the metabolic     activity of liver metastases by FDG-PET and SUV measurements.      Secondary endpoints Toxicity of neo-adjuvant treatment Complications of surgery   "
214535|NCT00659035|"     Many patients seen at Pain Centers are advised not to drive if they are on long-term opioid     medications. Although such advice is routinely given considering patients' safety,     unnecessary restrictions to driving can cause inconvenience to the patients and delay their     treatment. Such restrictions also pose social and legal questions to patients and physicians.      The investigators would like to test such patients' ability to drive under oral opioids using     a driving simulator at the Pain Center. This simulator is like a video game with computer and     a steering wheel to simulate real life driving. The driving simulator provides measure on     several outcome measures, such as attention, reaction time, etc. allowing us to specifically     address question pertaining to any cognitive or behavioral differences.   "
214536|NCT00659048|"     The primary objective of this study is to demonstrate that there are no clinically relevant     additive inhibitory effects on the HPA-axis when ciclesonide nasal spray is concomitantly     administered with orally inhaled HFA-BDP. The secondary objectives are to evaluate safety and     tolerability of the combined dosing regimen of orally inhaled HFA-BDP and ciclesonide nasal     spray.   "
214537|NCT00659061|"     The purpose of this study is 1) to evaluate the effectiveness in reducing anemia among     children 6-24 months of age by providing daily micronutrient Sprinkles through the Government     of Pakistan's Lady Health Worker program; 2) to assist in the monitoring the National     Sprinkles Pilot Project.   "
214538|NCT00659074|"     Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg     ODT   "
214539|NCT00659087|"     Hospital stays after total joint replacement surgery have been getting shorter over the past     10 years. This is mostly due to new ways to manage pain and early rehabilitation. To be able     to go home safely soon after surgery, patients need to:        -  1) have adequate pain control        -  2) be able to move through activities of daily living on their own (using aids)      Femoral nerve block, in combination with pain medications, is one of the new treatment     strategies that are currently being used at other hospitals in Canada, the United States and     the United Kingdom. Nerve blocks involve a needle filled with local anesthetic into the nerve     that allows the feeling of pain around the knee. With good pain management, patients will be     able to more quickly bend their knee and regain the ability to walk with aids and move from     sitting and lying positions to standing and walking. Once they can do these activities with     adequate pain control, they can be discharged from hospital to continue recovery at home. The     purpose of this study is to examine a new way of managing postoperative pain and encourage     early knee flexion and mobility, while maintaining pain control for patients after total knee     replacement. We believe that patients who receive the nerve block in addition to the regular     pain medication will have more knee flexion at discharge and experience less pain than     patients who only receive usual pain medications.   "
214540|NCT00659100|"     The purpose of this study is to assess consumers' behaviors related to gabapentin self-     selection and use, relative to warnings and directions for use, as described in the proposed     over-the-counter (OTC) product label.   "
214541|NCT00659113|"     RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy together with more than one drug (combination chemotherapy) may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving S-1 and cisplatin together with     radiation therapy works in treating patients with stage IIA, stage III, or stage IVA     esophageal cancer that can be removed by surgery.   "
214583|NCT00659672|"     The purpose of this study is to determine if consumption of whey protein, compared with soy     protein or a carbohydrate food decreases blood pressure along with reducing risk factors for     heart disease.   "
214584|NCT00659685|"     Single-dose cross over comparative bioavailability of Ondansetron 16 mg ODT and Zofran 16 mg     ODT   "
214585|NCT00659698|"     This study evaluated that strict control of perioperative blood glucose following hepatic     resection by using an artificial pancreas would improve postoperative surgical site     infection.   "
248526|NCT01108445|"     To compare the anti-tumor activity of everolimus and sunitinib in subjects with metastatic     renal cell carcinoma (mRCC) with non-clear cell pathology.   "
214588|NCT00659737|"     Recent evidence suggests multiple drug therapy is superior to single agents. The study     compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time,     and unplanned hospital admission in patients with high risk for PONV treated with oral     aprepitant with or without transdermal scopolamine preoperatively.   "
214589|NCT00659750|"     The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as     a nasal spray once daily in patients with PAR. The secondary objectives are to evaluate     Quality-of-Life and safety.   "
214544|NCT00659165|"     Patients with diabetes treated with insulin often gain weight, which may deter patients from     adhering to insulin treatment. Detemir is one type of long acting insulin approved by the     Food and Drug Administration for use in people with diabetes. It is similar to other long     acting insulins (Neutral Protein Hagedorn [NPH], glargine) except that it has been associated     with less weight gain compared to other types of insulin. The reasons for this are still     unclear. One possibility is that detemir insulin acts differently than do other insulins in     affecting how diabetic patients eat meals. The purpose of this study is to determine whether     appetite and calories eaten during a meal are affected by the type of insulin used to treat     diabetes. This is a pilot study which means we are gathering preliminary information to     determine if a larger study can be done.   "
214545|NCT00659178|"     The purpose of this study is to identify a dose of SB-485232 which is safe, tolerable and     biologically active when used in combination with pegylated liposomal doxorubicin (Doxil) in     patients with epithelial ovarian cancer. This study will use a standard treatment regimen of     pegylated liposomal doxorubicin (Doxil) in combination with rising doses of SB-485232. The     dose selected from this study will be used in a future studies to evaluate the efficacy of     this combination.   "
214546|NCT00659191|"     This study is a Phase I single and repeat dose escalation study of GSK1265744 in healthy     subjects and a single repeat dose cohort in HIV-1 infected subjects. The study is planned to     consist of three parts. Part A will enroll two cohorts with a total of 18 subjects in a     single dose escalation to evaluate safety, tolerability and PK. Part B plans to enroll three     cohorts of 10 subjects to evaluate repeat doses of GSK126744 on safety, tolerability and PK.     Part A and B will enroll healthy volunteers. Part C will enroll HIV-1 patients in a single     cohort of 10 subjects. This cohort will evaluate the effects of repeat dose on safety,     tolerability, PK and efficacy.   "
214547|NCT00659204|"     The purpose of this pilot study is to compare the antimicrobial efficacy of silver     nanoparticle gel to a commercialized alcohol-based hand gel on bacterial counts isolated from     the hands of 40 volunteers seeded with Serratia marcescens, a surrogate microbial marker.     Specific aims of this study are: Aim #1: Compare the immediate antimicrobial efficacy of a     one-time application of silver nanoparticle gel (SilvaSorb , AcryMed, Inc., Portland, OR)     versus an alcohol-based hand gel (Purell, GoJo Industries, Akron, OH) in reducing transient     bacterial counts isolated from hands seeded with S. marcescens.      Aim # 2: Compare the persistent antimicrobial efficacy of a one-time application of silver     nanoparticle gel (SilvaSorb) versus an alcohol-based hand gel (Purell) over a 10 minute time     frame in producing a persistent reduction on transient bacterial counts isolated from hands     seeded with S. marcescens.      Aim # 3: Compare user acceptability of silver nanoparticle gel (SilvaSorb) versus an     alcohol-based hand gel (Purell) using a self-assessment questionnaire.   "
214548|NCT00659217|"     Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing     properties. Manifestations of systemic lupus eryhematosus(SLE) may in most patients be     ameliorated with medications that suppress the immune system. Nevertheless, there remains a     subset of SLE patients for whom current strategies are insufficient to control disease. The     investigators will infuse expanded autologous MSC into patients with lupus Nephritis. The     purpose of this trial is to evaluate whether this new therapeutical approach will result in     improvement in the lupus disease.   "
214549|NCT00659230|"     This study proposes a multi-site, randomized, double-blind, placebo-controlled clinical trial     of the dopamine-ß-hydroxylase (DBH) inhibitor, nepicastat, for the treatment of posttraumatic     stress disorder (PTSD) in outpatients who have previously served in a combat zone during     Operation Iraqi Freedom and Operation Enduring Freedom (OIF/OEF)or other Southwest conditions     since 19800. A DBH inhibitor's mechanism of action is to decrease neuronal noradrenaline (NA)     release by inhibiting DBH conversion of dopamine (DA) to NA. Animal models of PTSD and human     studies have found a substantial increase in NA activity for these animal models and for PTSD     in humans. Furthermore, recent clinical studies have improved PTSD hyper-arousal symptoms by     reducing the NA over-activity using agents like NA post-synaptic antagonists. Key support for     the proposed study is based on a similar improvement in PTSD symptoms after treatment with     the DBH inhibitor, disulfiram.      In the experience of the clinical investigators, the most common chief complaint of the     OIF/OEF veterans with PTSD is hyperarousal (DSM-IV criterion D symptom cluster). These     symptoms significantly interfere with social, occupational, and interpersonal function.     Standard treatments with antidepressants are not fully effective in treating the symptoms of     PTSD in veterans; thus, new treatments are needed. An intervention, such as nepicastat, aimed     at reducing hyperarousal, as well as other PTSD symptoms, would have significant impact of     restoring overall function and quality of life in OIF/OEF veterans with PTSD. Since     hyperarousal symptoms responded relatively quickly to medications of this type, our study in     120 outpatient veterans with PTSD will compare nepicastat 120 mg/day vs. placebo in a 6-week     double-blind, randomized clinical trial (RCT). The veterans will be followed for an     additional 8 weeks after the RCT, during which, those who have a priori defined positive     clinical response to the study medication, nepicastat vs. placebo, will be continued on the     study medication, in order to assess further improvement and safety. Those patients who do     not have a positive clinical response during the 6 week RCT will be offered the addition of     the standard first-line PTSD pharmacotherapy, paroxetine, during the 8 weeks extension phase.     Thus, weeks 7-14 offer an opportunity to evaluate longer-term nepicastat efficacy and to     compare the treatment response of nonresponders after augmentation with paroxetine.   "
214550|NCT00659243|"     The purpose of this study is to evaluate the efficacy in preterm infants following treatment     with BSSL when administered in pasteurized breast milk.   "
214603|NCT00659932|"     This study was designed to assess whether a cognitive behavior therapy (CBT) program for     diabetes clinic patients was acceptable, improved quality of life and produced measurable     change in levels of depression, anxiety and stress.   "
214972|NCT00657709|"     The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to     lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with     routine infant vaccines.   "
214565|NCT00659438|"     This randomized, double-blind phase II trial is to assess the efficacy and safety of     bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with     castration-refractory metastatic prostate cancer without any clinical symptom related to     disease progression. The study is blinded, and subjects will be randomised (1:1 ratio) to     either ZD6474 300 mg or placebo. The blinded design ensures robust, unbiased data collection     and assessment. Placebo control is necessary to ensure a robust assessment of PSA PFS, and is     acceptable in this subject population where all subjects will also received bicalutamide 150     mg o.d. Subjects will continue study treatment until they reach objective biological disease     progression or unacceptable toxicity or withdrawal of consent or until end of trial (which     event occurs first). The end of study is fixed 12 months after the last randomised patient's     first dose of study treatment.   "
214775|NCT00661180|"     The purpose of this study is to evaluate the anti-cancer activity and safety of Bay 43-006,     in patients who have Chronic Myelogenous Leukemia that resisted to Gleevec treatment, one of     the standard medication administered for these patients.   "
214551|NCT00659256|"     This study will examine the effects of treatment for hepatitis C on atherosclerosis, or     hardening of the arteries. Hepatitis C is a disease of the liver caused by a virus that can     cause permanent damage to that organ. Treatment can clear the virus in at least half of     patients and reduce the risk of serious complications of the disease. Atherosclerosis is an     accumulation of cholesterol and fat in the arteries that can narrow blood vessels, leading to     chest pain, heart attack or stroke.      Because the liver controls cholesterol and fat levels in the blood, hepatitis C infection may     be a risk factor for atherosclerosis by increasing cholesterol and fat in blood vessels.     Treatment of the hepatitis C may reduce the risk of atherosclerosis and its consequences.     This study will determine what effect hepatitis C treatment has on the rate of     atherosclerosis and narrowing of blood vessels and on the risk of heart attack or stroke.      Patients 30 years of age and older with current or past infection with hepatitis C may be     eligible for this study. Participants undergo the following tests and procedures:        -  Questionnaires regarding risk factors for heart disease and stroke        -  Measurements of blood pressure, heart rate, weight, height, waist and hips        -  Blood tests        -  CT scans and ultrasound tests to measure the degree of blood vessel hardening and          narrowing in the heart and neck region   "
214552|NCT00659269|"     Many types of chemotherapy may cause nerve damage as a side effect. This neurotoxicity can     manifest as peripheral sensory neuropathy (characterized by numbness, tingling, or pain). The     goal of this study is to determine the efficacy of the combination of vitamin B6 and B12 in     preventing chemotherapy induced neuropathy.   "
214553|NCT00659282|"     This study is conducted in Asia, Europe, Japan and North America. The aim of this     observational study is to evaluate the safety and effectiveness while using NovoMix® 30     during 26 weeks under normal clinical practice, in the countries participating in the study.     The primary outcome is the incidence of major hypoglycaemic events reported as serious     adverse drugs reaction conditions on hypoglycaemic events.   "
214554|NCT00659295|"     This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this     observational study is to evaluate the incidence of serious adverse reactions (SARs) while     using Levemir® (insulin detemir) under normal clinical practice conditions.      Study conducted globally in 26 countries. Some countries participated in the study for only 3     months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey),     while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece,     India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and     United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.   "
214555|NCT00659308|"     The purpose of this study is to determine whether amniotic membrane transplantation is as     effective as anterior stromal puncture in the relief of symptomatic bullous keratopathy.   "
214556|NCT00659321|"     Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial     dyslipidemia in patients with metabolic syndrome. Nicotine acid decreases postprandial     hyperlipidaemia in patients with metabolic syndrome which reduces the low-grade inflammation     and the risk of atherosclerosis.   "
214557|NCT00659334|"     Combidex (ferumoxtran-10) is an ultra-small iron oxide particle covered with a sugar coating.     It has been evaluated as an MRI contrast agent for use in imaging well perfused organs such     as the liver and spleen and for imaging lymph nodes. In this study, Combidex is being used to     compare the standard imaging agent, Gadolinium, in imaging brain tumors and the area adjacent     to the tumor location. Combidex may provide the ability to better see brain tumors and     inflammatory lesions on magnetic resonance imaging (MRI) scans. Combidex may be useful in its     ability to cross blood vessels into brain tumors, and because of its size and ability to get     into the area next to brain tumors, could assist in the treatment of brain tumors with other     drugs in the future.   "
214558|NCT00659347|"     The primary objectives of this placebo-controlled trial are to evaluate effectiveness and     safety of DOV 21,947 at two oral dose levels.   "
214559|NCT00659360|"     This phase II trial is studying how well AZD0530 works in treating patients with recurrent     locally advanced, or metastatic soft tissue sarcoma. AZD0530 may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
214560|NCT00659373|"     RATIONALE: Learning about the long-term effects of adjuvant tamoxifen (T), adjuvant tamoxifen     with ovarian function suppression (T+OFS), and exemestane with ovarian function suppression     (E+ OFS) on brain function may help doctors plan cancer treatment.      PURPOSE: This study is looking at brain function in premenopausal women who are receiving     adjuvant tamoxifen (T) alone against those receive adjuvant tamoxifen (T+OFS) or exemestane     (E+OFS) with ovarian function suppression (OFS) for early-stage breast cancer on clinical     trial IBCSG-2402.   "
214561|NCT00659386|"     Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with     progressive cardiac dysfunction and evolution to dilated cardiomyopathy.      Objective: Whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional     heart failure therapy achieves virus reduction, thereby resulting in improvement of cardiac     function.      Study design: A interventional study of virus presence and cardiac functional capacity before     and after IVIg therapy.      Study population: Patients with idiopathic cardiomyopathy and symptomatic heart failure for     more than 1 year and a significant PVB19 viral load in endomyocardial biopsies (EMB) and     treated with high dose of IVIg were included.      Intervention (if applicable): Patients were treated with a total dose of 2 g/kg of immune     globulin administered as 0.5 g/kg IV over a period of 6 hours on each of 4 consecutive days.      Main study parameters/endpoints: EMBs: virus (PVB19, enteroviruses, adenoviruses,     Epstein-Barr virus, human herpes virus-6 and cytomegalovirus), inflammation (lymphocytes an     macrophages) and fibrosis. Cardiac functional capacity: NYHA classification,     echocardiographic evaluation (left ventricular ejection fraction, end-systolic diameter,     end-diastolic diameter).   "
214562|NCT00659399|"     The purpose of this study is to assess feasibility and safety of using once daily     Fondaparinux Sodium (ARIXTRA®) in patients with ovarian cancer who are in 'clinical     remission' (no clinical evidence of disease) after chemotherapy but at high risk of ovarian     cancer recurrence.   "
214563|NCT00659412|"     Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing     alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension     with only alefacept + MTX treatment.   "
214566|NCT00659451|"     The anthypertensive treatment with Losartan may have benefits beyond blood pressure reduction     on myocardial structure and function in hypertensive diabetic patients. We will evaluate the     effect of losartan treatment on structural characteristics of myocardium in hypertensive     diabetic patients:        1. left ventricular mass, intraventricular septal thickness, fractional shortening.        2. myocardial qualitative alteration and heterogeneity of myocardial tissue that describes          myocardial texture and echodensity, related to collagen deposition; myocardial          qualitative alteration will be evaluate by ultrasonic myocardial integrated backscatter          signals (IBS) both as peak end diastolic signal intensity and as cardiac cyclic          variation        3. alteration of diastolic function as studied by Doppler flow velocities across the mitral          valve (Pulse Wave Doppler) and pulse wave Tissue Doppler Imaging parameters        4. aortic strain and distensibility (that is in relation with LVH)        5. epicardial adipose tissue measurement (this parameter is related to the visceral fat and          may be an easy method to indicate patients with high cardiovascular risk).   "
214567|NCT00659464|"     PURPOSE OF THE STUDY      This study will explore the use of multi-site NIRS monitoring during tilt table testing,     combining somatic and cerebral saturations data with hemodynamic data to establish the     non-invasive assessment of global cardiac output distribution trends.      HYPOTHESIS / SPECIFIC AIMS      Study Aims: To evaluate the utility of multi-site NIRS monitoring in the cardiovascular     hemodynamic assessment of children and adolescents during tilt table testing by establishing     a non-invasive method to predict cardiac output maldistribution with the use of two-site NIRS     monitoring in children and adolescents with syncope.   "
214568|NCT00659477|"     Aim of the study is to compare two treatment regimens (insulin Lantus as basal insulin vs     insulin NPH) plus oral antidiabetics in type 2 diabetic patients and confirm superiority of     insulin glargine. Comparison is focused on: blood glucose (BG) variability of the two     treatment regimens, quality of diabetes compensation (HbA1c, FBG/Fasting blood glucose), body     weight development, dose of insulin and occurrence of symptomatic hypoglycaemia and other     adverse events.   "
214569|NCT00659490|"     The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by     the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of     AZD1940 to placebo (inactive substance) on pain. A number of patients will instead receive     the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen,     will be allowed if a need for additional painkillers would arise. A number of patients will     receive Naproxen as control.   "
214570|NCT00659503|"     The primary objective of this placebo-controlled EEU study is to determine the time to onset     of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR.   "
214571|NCT00659516|"     The smart capnography respiratory index is a software tool that constitutes a representation     of 4 parameters: End Tidal CO2, respiratory rate, O2 saturation and heart rate already     displayed on a monitor in the form of a single respiratory index integer value ranging from 1     to 10 with trend information. The index is to be used to identify and display status and     changes in patient respiratory status in a simple manner based on the summary of changes in     the 4-above mentioned parameters. the respiratory index is to be used in varied clinical     environments and is intended for use in adult and pediatric patients.   "
214572|NCT00659529|"     The purpose of this study is to determine whether sildenafil can decrease inflammation in CF     lung disease.   "
214573|NCT00659542|"     The purpose of the study is to investigate whether chronic postoperative pain is less     frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared     to conventional sutures in inguinal hernioplasty.   "
214574|NCT00659555|"     This is a two-period study to evaluate the effect of repeat oral dosing of ketoconazole on     the pharmacokinetics of single dose pazopanib administered as an eye drop   "
214575|NCT00659568|"     RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of metformin when     given together with temsirolimus in treating patients with metastatic or unresectable solid     tumor or lymphoma.   "
214576|NCT00659581|"     The primary objective of this post marketing survey is to prospectively investigate patients     with hypertension treated with Micardis Tablets (hereinafter this drug) in routine clinical     settings for 3 years in order to determine the following:        1. Adverse events and adverse drug reactions under long-term use        2. Blood pressure measurements during the survey period        3. Determination of the incidence of cerebrovascular and cardiovascular events under use of          this drug in routine clinical settings        4. Patient's lifestyle and background factors that are considered to affect the occurrence          of cerebrovascular and cardiovascular events   "
214577|NCT00659594|"     The primary objective of this placebo-controlled EEC study is to determine the time to onset     of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR.   "
214578|NCT00659607|"     This Post Marketing Surveillance (PMS) study aims to review the followings by investigating     the actual practice of MicardisPlus Tablet on the market:        1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs))        2. Frequency of incidence and its change in adverse events (AEs)        3. Factors on the safety profile of the study drug        4. Factors on the efficacy profile of the study drug   "
214656|NCT00653549|"     To compare the single-dose bioavailability of Torsemide tablets with Demadex   "
214586|NCT00659711|"     Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in combination     with metformin or a thiazolidinedione for control of type 2 diabetes mellitus. Sitagliptin     has been shown to have fewer side effects in the control of blood glucose values.      Obesity and diabetes are states of increased inflammation and can influence the free radicals     and inflammatory markers (chemicals in the blood which increase due to inflammation in the     body) and are also major risk factors for atherosclerotic disease. In this study we want to     see the effect of sitagliptin on these markers. We believe that Sitagliptin may exert an     anti-inflammatory effect in the human. The purpose of this study is to determine if the     addition of sitagliptin to diabetic patients will provide added benefit. We believe that     sitagliptin provides these added benefits by suppressing free radicals (charged substances     that cause damage to the body) and inflammation.   "
214590|NCT00659763|"     The purpose of this study is to determine whether a clinical diagnosis of irritable bowel     syndrome based on patient reported symptoms and a few blood tests is safe, and to determine     whether a clinical diagnosis is as good for the patient and as economical for the society as     a diagnosis based on exclusion of a number of organic diseases by performing a number of     blood tests, fecal analyzes and a scopic examination of bowel.      The purpose of the second part of the study is to determine which intestinal parasites the     patients have in their bowel and whether these parasites are the cause of the disease.   "
214591|NCT00659776|"     The purpose of this study is to address safety and efficiency of a new iron particle contrast     agent, ferumoxytol. This product may be more useful in viewing the vessels of the brain and     areas in the brain on magnetic resonance imaging (MRI), or magnetic resonance angiography     (MRA), than the standard substance, gadolinium, injected during MRI and MRA.      Other ways in which ferumoxytol may help include the following:        1. Ferumoxytol may provide the ability to better see inflammatory lesions on magnetic          resonance imaging (MRI) scans        2. Ferumoxytol may be useful in its ability to cross blood vessels into inflammatory          processes, and        3. Ferumoxytol, because of its size and ability to get into the area next to your          inflammatory lesion and could assist in the treatment of inflammatory lesions          association with cardiac surgery or CNS vascular surgery.   "
214592|NCT00659789|"     Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure     the infection, making it a life-long treatment that requires sustained patient compliance and     imposes significant individual and societal financial burdens on healthcare services.     Furthermore, ART side effects often require medication that increases the inconveniences and     financial burdens of HIV management. Of further concern is the emergence of viruses resistant     to ART that can result in treatment failure.      ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV     immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this     study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.   "
214593|NCT00659802|"     The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with     active mild to moderate ulcerative colitis (UC), compared with placebo.   "
214594|NCT00659815|"     The objective of the study is to evaluate the product performance of Bausch & Lomb ReNu     MultiPlus Multi-Purpose Solution in a new packaging configuration   "
214595|NCT00659828|"     We will assess the endocrine and immune effects of leptin replacement in leptin-deficient     children, from a consanguineous Turkish family. We hypothesize that leptin replacement will     have significant effects on immune and endocrine function.   "
214596|NCT00659841|"     The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as     a nasal spray once daily in patients with SAR. The secondary objectives are to evaluate     Quality-of-Life and safety.   "
214597|NCT00659854|"     Cow's milk allergy may be involved in the evolution of sleep apnea in infants. The study will     assess the effects of specifies diet changes (i.e. non-milk based formula) on the infant.     Specifically , infants will be investigated by sleep studies in order to test this     hypothesis.   "
214598|NCT00659867|"     This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study     in subjects with long standing ulcerative colitis in clinical remission with indication for     surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and     EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted     biopsies or by standard endoscopy with random and targeted biopsies. The aim is to     investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard     endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the     proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy     versus standard endoscopy.   "
214599|NCT00659880|"     This study will follow patients after routine surgery of a meniscal allograft transplant.   "
214600|NCT00659893|"     Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25     cm2 treatment areas, as compared to individual 25 cm2 treatment areas.   "
214601|NCT00659906|"     The purpose of this study is to conduct a 12-month randomized controlled trial comparing the     effects of strength training exercise to stretching and relaxation exercise (control) on body     composition (bone, muscle and fat mass), energy balance, bone turnover, and physical function     (strength, power, gait, balance and self-report physical function and symptoms) in women who     experienced premature menopause from chemotherapy for breast cancer.   "
214602|NCT00659919|"     Administration of trazodone for the treatment of neuroleptic induced acute akathisia in a     cross-over fashion of 6 days duration. 3 days of placebo and 3 days of trazodone.   "
214604|NCT00659945|"     Hypothesis: Aprepitant plus ondansetron is more effective than ondansetron plus placebo for     prevention of postoperative emesis in patients at moderate-to-high risk for PONV for up to 48     hours after surgery.      Specific Aim: To determine the incidence of PONV during the first 48 hours after surgery; in     patients who have received aprepitant plus ondansetron versus ondansetron plus placebo for up     to 48 hours after surgery.   "
214605|NCT00659958|"     The purpose of this study is to acquire additional information about the appropriate level of     dosing of Zonisamide when it is prescribed for patients with partial onset epileptic crisis     who are already being treated with two other antiepileptic drugs.   "
214606|NCT00659971|"     The purpose of this study is to determine the optimal dose of PAC113 mouthrinse for treatment     of oral candidiasis in HIV seropositive patients.   "
214607|NCT00659984|"     RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry     radiation directly to tumor cells and not harm normal cells. A bone marrow or peripheral stem     cell transplant using stem cells from the patient may be able to replace blood-forming cells     that were destroyed by I 131 MIBG.      PURPOSE: This phase II trial is studying the side effects and best dose of iodine I 131 MIBG     followed by a stem cell transplant in treating young patients with relapsed or refractory     high-risk neuroblastoma.   "
214705|NCT00654186|"     This is a single institution, open label, phase II study in androgen-independent prostate     cancer patients who are chemotherapy-naïve. Patients will receive Revlimid® 25 mg daily on     Days 1-21 followed by 7 days of rest repeated every 28 days. Treatment continues until     disease progression, patient's withdrawal, unacceptable toxicity or the investigator's     discretion.   "
214608|NCT00659997|"     Field epidemiological studies undertaken during 2005 in four village locations in Northern     Unguja, Zanzibar examined mothers and their pre-school aged children for helminth infections.      The prevalence of Ascaris lumbricoides was found to have remained relatively high despite     community-wide treatment with the mass administration of Albendazole (a WHO recommended     de-wormer) in coordination with community vitamin A supplementation.      One hypothesis for this is that the children and mothers had Ascaris infections more tolerant     to Albendazole that subsequently failed to clear. It is necessary to compare the present drug     efficiency of Albendazole (first-line de-wormer) with Levamisole (second-line de-wormer) on     STH infections such patients a case-control setting to shed light on the putative resistance     of local Ascaris/Trichuris to albendazole.      In so doing, this should clarify whether there is resistance developing towards Albendazole     and have possible implications for introducing combination therapies of Levamisole and     Albendazole for first line de-worming mothers and their children in the future.   "
214609|NCT00660010|"     The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and     effective in treating children with Central Precocious Puberty (CPP), and to assess long term     effects of leuprolide acetate treatment after therapy is discontinued.   "
214610|NCT00660023|"     This single-arm study will assess the efficacy and safety of monthly administration of     intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of     hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine     clinical practice in Hungary. Participants currently receiving maintenance treatment with     intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the     starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been     receiving.   "
214611|NCT00660036|"     The purpose of this study is to investigate the combination of gemtuzumab ozogamicin,     mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.   "
214612|NCT00660049|"     The purpose of this study is to evaluate the feasibility and usability of a new portable and     compact wound dressing device for the treatment of small chronic skin wounds.   "
214613|NCT00660062|"     The main purpose of this study is to investigate the relapse preventing efficacy of     escitalopram in a dose range and nortriptylin in a single dose in patients having been     treated successfully with a course of electroconvulsive treatment (ECT).   "
214614|NCT00660075|"     Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-4), and has     been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes     mainly through incretin hormone-mediated improvements in islet function. Although clinical     studies to date indicate that fasting lipid levels are minimally affected by DPP-4 inhibitor     treatment, animal studies suggested that DPP-4 inhibition reduce intestinal triglyceride (TG)     absorption and apolipoprotein production and increased chylomicron catabolism. Therefore, the     present study was designed to examine the effects of sitagliptin on postprandial lipemia in     patients with type 2 diabetes. A possible reduction in postprandial atherogenic     triglyceride-rich lipoproteins (TRL) levels by sitagliptin would add to therapeutic utility     of this DPP-4 inhibitor and suggest the potential to reduce cardiovascular risk in patients     with type 2 diabetes.   "
214615|NCT00660088|"     AC-1202 (Ketasyn) is a nutritional beverage currently being studied in neurodegenerative     conditions including Alzheimer's disease. The current study is a randomized, open-label trial     to compare the safety, tolerability, and PK profiles of 3 formulations of Ketasyn     administered on a daily basis for 14 days, with and without a 7-day titration period, in     normal, healthy elderly volunteers.   "
214616|NCT00660101|"     To determine if a vaccine made from the patient's own tumor tissue can stimulate an immune     response against the patient's tumor cells. To determine the safety of the vaccine.   "
214617|NCT00660114|"     This open label, non-interventional study is to show the efficacy of Pulmicort®Respules® in     cough variant asthma in patient aged 5-year old or younger in outpatient department   "
214618|NCT00660127|"     The purpose of this research study is to assess whether seeing other people itch affects itch     perception in patients with atopic dermatitis and healthy subjects.   "
214619|NCT00660140|"     To determine the activity of gemcitabine combined with carboplatin in the treatment of     patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer.   "
214620|NCT00660153|"     The FOLFOX6 regimen is a standard chemotherapy regimen for the treatment of patients with     colorectal cancer and other gastrointestinal cancers. Tivozanib (AV-951) is a targeted     anti-angiogenesis agent that has demonstrated acceptable tolerability in a phase I clinical     trial. This study is designed to test the hypothesis that tivozanib (AV-951) can be combined     with standard FOLFOX6 chemotherapy for the treatment of patients with colorectal and other     gastrointestinal cancers. The purpose of this study is to determine the maximum dose of     tivozanib (AV-951) that can be safely combined with FOLFOX6 chemotherapy, and to evaluate the     safety profile, tolerability, and pharmacokinetics of this combination.   "
214657|NCT00653562|"     To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography   "
214621|NCT00660166|"     The purpose of this research study is to examine the safety of infusing escalated doses of     allogeneic (from a relative of the patient), enriched natural killer (NK) cells after     autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion     of these NK cells early after an autologous stem cell transplant will help to eliminate and     eradicate any residual cancerous cells that remain in the body and may have survived the     chemotherapy or radiation.   "
214622|NCT00660179|"     The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two     different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with     symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992)     prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk     profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.   "
214623|NCT00660192|"     The hypothesis of this study is that injection of botulinum toxin A into the muscles around     the head (frontal, temporal, posterior neck, occipital) can reduce the intensity and     frequency of migraine headaches by 50%.   "
214895|NCT00662740|"     The primary objectives of this study are to assess bronchodilator efficacy as determined by     FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as     determined by the SGRQ and the effect on COPD exacerbations.   "
214624|NCT00660205|"     Cancer is a well known risk factor for venous thromboembolism (VTE) such as deep venous     thrombosis (DVT) and pulmonary embolism (PE). Today we know that patients with     adenocarcinomas of the gastro intestinal tract (GI-tract) often is in a hypercoagulable     state.      In our observational study we collect patients admitted to department with a tentative     diagnosis of upper GI cancer including pancreas cancer and offer them flow doppler     ultrasounds of both legs for diagnosis of DVT in the entire treatment time. The routine     CT-scan of the chest is modified to diagnose PE. This will be compared with blood samples     analysed for coagulation markers including D-dimer - a fibrinogen degradation product.   "
214625|NCT00660218|"     This study involves two phases. Phase I of this study is designed to find out the maximum     dose of paclitaxel poliglumex which can be safely given to subjects when combined with     cetuximab and radiotherapy in head and neck cancer. Once the maximum safe dose of paclitaxel     poliglumex is found, Phase II of the study will continue to find out whether the addition of     paclitaxel poliglumex increases tumor response and survival compared to treatment with     cetuximab and radiotherapy alone.      An additional 20 patients have been added, to balance data. These patients must be HPV     negative.   "
214626|NCT00660231|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and bexarotene, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase II trial is studying giving gemcitabine together with bexarotene to see     how well it works in treating patients with progressive or refractory stage IB, stage II,     stage III, or stage IV cutaneous T-cell non-Hodgkin lymphoma.   "
214627|NCT00660244|"     The purpose of this study is to investigate efficacy and tolerability under anastrozole     (Arimidex) treatment.   "
214628|NCT00660257|"     A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate     the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1)     vaccine (whole-virion, aluminium-adjuvanted).   "
214629|NCT00653172|"     The purpose of this study is to compare the efficacy, safety and tolerance of 2 different     dose levels of oral NXL103 with oral comparator in the treatment of community acquired     pneumonia in adults   "
214630|NCT00653185|"     The purpose of this study is to determine the efficacy, safety and tolerability of SYR-472,     once daily (QD), in subjects with Type 2 Diabetes Mellitus.   "
214631|NCT00653198|"     This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as     a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised     children born after 1 March 2006, which corresponds to the date of introduction of Rotarix™     in the national immunization program.   "
214632|NCT00653224|"     The study objective is to investigate the efficacy of levocetirizine in reducing symptoms     associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life.   "
214633|NCT00653237|"     We evaluate two new developed airway devices, which provide patent airway during general     anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a     difficult airway by using an extrication device collar). We then place consecutively both     airway devices in the mouth and check for ease of insertion and time used.   "
214634|NCT00653250|"     RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This clinical trial is studying celecoxib in treating patients with stage I, stage     II, or stage IIIA non-small cell lung cancer.   "
214635|NCT00653263|"     Methamphetamine use has escalated in recent years. Methamphetamine use has also spread     throughout the country. Although much information has been gathered on the treatment of     cocaine abuse, very little information has been obtained on the treatment of methamphetamine     abuse. One of the first steps in developing appropriate treatment is to examine the effects     of stopping a particular substance's use on individuals abusing that substance. To date this     has not been well studied for people abusing methamphetamine. The purpose of this study is to     better understand and develop accurate ways of measuring symptoms associated with stopping     the use of methamphetamine in people that are abusing methamphetamine. If the withdrawal     symptoms are able to be effectively measured, this will help to develop treatments targeted     at alleviating these symptoms. These symptoms are often associated with relapse to use of     that substance.   "
214636|NCT00653276|"     Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of     a single oral dose cyclosporine in young healthy males and females.   "
214658|NCT00653575|"     This study will evaluate whether childhood experiences are related to current sexual behavior     of adult women.   "
214659|NCT00653588|"     The purpose of this study is to compare the effect of 8 weeks of treatment with Rosuvastatin     with 8 weeks of treatment with Atorvastatin on low density lipoprotein cholesterol level in     subjects with hypercholesterolemia and coronary heart disease (CHD) or at high risk of CHD..   "
214849|NCT00662142|"     The goal of this study is to determine if 8-week dietary treatment with the omega-3 fatty     acid docosahexaenoic acid (DHA) improves attention performance and associated cortical     activity and metabolism in 8 - 10 year old males that were not breast-fed during infancy.   "
214637|NCT00653302|"     Primary objective:        -  Efficacy assessment of the percentage of positive responders patients receiving Lantus          plus glucophage association. Positive responders patients are defined by a final value          of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final          - HbA1c basal).      Secondary objectives:        -  Determination of the predictive criterion of HbA1c final,        -  Determination of the predictive criterion of weight variation,        -  Description of the glycemic and therapeutic criteria in the both groups of responders          (positive and negative responders),        -  Assessment of the lipidic parameters according to the HbA1c and weight changes during          the study (final value - basal value).      Safety:        -  Adverse Event (AE)/Serious Adverse Event (SAE) assessments   "
214638|NCT00653315|"     To compare the relative bioavailability of Kali and Ortho-McNeil's   "
214896|NCT00662753|"     The purpose of this study is to determine if the use of home blood pressure monitors plus     nurse telephone monitoring is more effective than the use of blood pressure monitors alone in     improving control of high blood pressure in an urban medical clinic.   "
214639|NCT00653328|"     RATIONALE: There is emerging data to suggest that the optimal use of angiogenesis inhibitors     may be in combination with chemotherapy. The optimal use of atrasentan may be in combination     with chemotherapy in women with relapsed and refractory ovarian cancer,fallopian tube cancer,     and peritoneal serous papillary adenocarcinoma. Due to its manageable toxicity profile, ease     of administration, and activity in both platinum sensitive as well as platinum-resistant     patients, Doxil has become the 2nd-line treatment of choice for women with advanced stage     ovarian cancer that has progressed following 1st-line platinum/taxane therapy.      PURPOSE: To determine if a treatment combination of atrasentan + Doxil is an effective 2nd     line treatment in patients with recurrent ovarian cancer, fallopian tube cancer, or     peritoneal cancer.   "
214640|NCT00653341|"     The primary objective of this study is to compare the percentage of subjects who reach the     target HbA1c level (< or = 7.0% at endpoint) and do not experience symptomatic nocturnal     hypoglycemia during treatment with insulin glargine or NPH human insulin.   "
214641|NCT00653354|"     To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib     compared to placebo on the first post-operative day in patients with moderate or severe pain     following bunionectomy surgery.   "
214642|NCT00653367|"     The purpose of this study is to investigate if controlled nerve section reduces chronic pain     after thoracotomy.   "
214643|NCT00653380|"     To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent     to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals).   "
214644|NCT00653393|"     To compare the single-dose Bioavailability of Tranylcypromine and Parnate   "
214645|NCT00653406|"     The purpose of this study is to explore the pharmacokinetic profile and safety after biweekly     (every 2-week) intramuscular (IM) injections (6 injections) of risperidone long acting     injectable 25, 37.5, or 50 mg/dose in schizophrenic patients. The efficacy of the study     medication will also be assessed.   "
214646|NCT00653419|"     To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl     Tablets   "
214647|NCT00653432|"     The purpose of this study is to determine whether intra-articular hyaluronic acid provides     symptomatic relief of osteoarthritis of the knee.   "
214648|NCT00653445|"     The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared     with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density     lipoprotein level goals.   "
214649|NCT00653458|"     To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg   "
214650|NCT00653471|"     The purpose of this study is to compare the accuracy of EtPCO2 measurements taken with a     nasal cannula using the Microcap (Oridion Capnography Inc., Needham, MA) micro-stream device     and the TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). Three groups of     non-intubated, spontaneously breathing patients will be included: 1) lean patients without     obstructive sleep apnea (OSA); 2) obese patients without OSA; and 3) obese patients diagnosed     with OSA. This latter group has a higher prevalence of oral breathing.      Additionally, to test the efficacy of oral guides, we propose to compare the accuracy of     EtPCO2 measurements from the Microcap with two different nasal cannulas, one with (Smart     CapnoLine PlusTM, Oridion Medical, Jerusalem, Israel) and one without (CapnoLineTM H, Oridion     Medical) an oral guide to trap gas expired from the mouth. The TG-920 main-stream system     requires its purpose-designed YG-122T cannula so that is the only one that will be tested     with the Nihon-Kohden product.   "
214651|NCT00653484|"     RATIONALE: Calories and physical exercise may affect the risk of developing cancer. It is not     yet known whether a low-calorie diet and/or physical activity program is effective in     preventing cancer in participants at increased risk of developing colorectal cancer.      PURPOSE: This randomized clinical trial is studying diet and physical activity in healthy     overweight, obese, or inactive participants at risk of developing colorectal cancer.   "
214652|NCT00653497|"     The purpose of this study was to estimate the cost and outcomes of the Arthritis Foundation     aquatic exercise classes.        -  DESIGN. Randomized trial of 20-week aquatic classes.        -  SUBJECTS AND METHODS. Recruited 249 adults from Washington State aged 55 to 75 with a          doctor-confirmed diagnosis of osteoarthritis        -  MEAURES. The Quality of Well-Being Scale (QWB), Current Health Desirability Rating          (CHDR), Health Assessment Questionnaire(HAQ), Center for Epidemiologic          Studies-Depression Scale (CES-D), Perceived Quality of Life Scale (PQOL)   "
214653|NCT00653510|"     The purpose of the study is to characterize the changes in amino acid, lipid and glucose     metabolism in patients with type 2 diabetes exposed to acute hyperglycemia. Moreover we wish     to assess the effect of acute hyperglycemia on cardiac output.   "
214654|NCT00653523|"     Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin     in patients with hypercholesterolemia who have not reached low density lipoprotein     (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase     inhibitors.   "
214655|NCT00653536|"     Patients with acute ischemic stroke and persistent arterial occlusion following failed     mechanical revascularization, who can undergo NeuroFlo treatment within 18 hours of last time     symptom free, will be eligible for enrollment to assess the safety and feasibility of the     NeuroFlo catheter in treating ischemic stroke patients with persistent arterial occlusion     following attempted thrombectomy. The NeuroFlo catheter is designed to partially obstruct the     abdominal descending aorta thereby increasing blood flow to the brain. Cerebral perfusion is     improved by diverting more blood through vessels as well as by expansion of the collateral     circulation. Improved regional perfusion leads to clinical improvement.   "
214672|NCT00653757|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Using scintigraphy     to plan specialized radiation therapy that delivers a high dose of radiation directly to the     tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This phase I/II trial is studying the side effects and best way to give     intensity-modulated radiation therapy and to see how well it works in treating patients with     stage I, stage II, stage III, or stage IV prostate cancer.   "
214773|NCT00661154|"     To determine whether using a radiolabelled analog of 5-FU, [18F]-5-fluorouracil, for PET/CT     imaging can visually demonstrate differential chemotherapy delivery to known tumor sites     before and after administration of bevacizumab and determine the optimal timing of     bevacizumab administration to maximize the chemotherapy delivery into the tumor for improved     cancer treatment.   "
214660|NCT00653601|"     Patients who have undergone placement of coronary stents require dual antiplatelet therapy     with Plavix and aspirin to prevent the serious complication of in-stent thrombosis. Some of     these patients will require surgery while on dual antiplatelet therapy. This poses a     challenge because being on Plavix is associated with higher risks of perioperative bleeding,     but stopping Plavix puts patients at increased risk for in-stent thrombosis.      Currently, the ACC/AHA guidelines recommend discontinuation of Plavix five days prior to     surgery to prevent bleeding complications. However, there are no universal recommendations     for preventing in-stent thrombosis. Some experts recommend the use glycoprotein IIb/IIIa     inhibitors (short-acting antiplatelet agents) as bridging therapy during the high-risk     perioperative period. Although these agents should be beneficial based on theory, there is     currently no published data on their effectiveness for this purpose.      The current study proposes to evaluate the value of Aggrastat (a short-acting intravenous     platelet glycoprotein IIb/IIIa inhibitor) in decreasing the risk of in-stent thrombosis     without increasing the risk of perioperative bleeding.   "
214661|NCT00653614|"     The study will be performed as a multi-center, randomized, double-blind, parallel-group trial     in fertile women aged between 18 and 35 years inclusive. A total of 600 volunteers will be     randomized into one of the six treatment groups. The study will be performed only in Germany.     The investigational drug is an oral contraceptive. It contains the estrogen estradiol (E2)     and the progestogen drospirenone (DRSP). As the contraceptive efficacy has not yet been     proven for these new regimens, even a protection against unwanted pregnancies cannot be     assured. The treatments will be applied daily for 7 cycles of 28 days each without pill-free     interval, i.e., for 196 consecutive days. Treatment will be initiated after a screening     period of approximately 1 to 2 weeks, the latter focused on confirmation of the baseline     safety status. Tablet intake will start on the first day of the first menstrual/withdrawal     bleeding after Visit 2, regardless of whether the volunteer is a first user (starter) or     switching from another COC. In the following cycles, tablet intake is not to be triggered by     any bleeding events. The primary objective of this study is to evaluate and compare the cycle     control and bleeding patterns of six different treatment regimens with E2/DRSP during     administration for 7 treatment cycles. Volunteers will be provided with a diary to document     the intake of study medication, any bleeding events, and days without bleeding, pregnancy     test results. Safety will be also assessed. During the whole study period, 4 visits are     planned. At Screening and Final examination, a thorough physical examination and a     gynecological examination (including breast palpation and cervical smear ) will be performed.     Blood samples will be taken for safety laboratory parameters.Additional examinations can be     performed any time, if this becomes necessary for medical reasons. At Visit 3 or in case of     premature discontinuation of study the investigator will discuss options for follow-up     contraception with the volunteer. The volunteer can start the intake of a post-treatment OC     on the day after the last tablet intake of study medication, after a negative urine ß-HCG     test (home pregnancy test) result.   "
214662|NCT00653627|"     This is a human pilot study of 16 healthy BCG-naïve volunteers to quantify BCG from the BCG     vaccination site. Volunteers will be vaccinated with BCG. The first 8 will go on to have a     punch biopsy and suction blister of the vaccination sites at 2 weeks post vaccination (arm A)     the second 8 will have a biopsy and blister at 1 or 4 weeks post-vaccination (arm B). Methods     of mycobacterial quantification on these tissue samples will then be compared   "
214663|NCT00653640|"     The purpose of this study is to determine whether body weight supported treadmill training is     more effective than traditional physical therapy at restoring gait in persons recovering from     traumatic brain injury.   "
214664|NCT00653653|"     Using a prospective study design of two three month periods (before and after genotyping) in     which the patients will self-monitor their health status and possible medical events it is     hypothesized that it will be shown that patients having their medication altered to fit their     genetic status and/or having their medication altered because of inherent interaction     potential will have less recordable events after genotyping and medical analysis than before.      It is well known that ADRs (recordable adverse events to medication) are responsible for a     large number of deaths and hospitalizations. Furthermore it is well recorded that genotyping     of individual cytochrome P450 enzymes (2D6, 2C9, 2C19, among others) is directly related to a     metabolic phenotype - fast metabolisers, slow metabolisers, intermediate and normal     metabolisers. These differing phenotypes have altered metabolism of many medications and in a     number of retrospective clinical trails it has been shown that ADRs and effect can be     reduced/bettered through genotyping and alteration of medication.   "
214665|NCT00653666|"     The purpose of this study is to learn more about how long children with CPT-1 deficiency can     wait between meals without developing low blood sugar or symptoms of low blood sugar. The     other purpose is to learn more about how much fat is stored in the liver of a child with     CPT-1 deficiency.   "
214666|NCT00653679|"     This study examines the muscle protein signalling response after resistance and endurance     exercise. We hypothesize that the signalling response after endurance and resistance exercise     will be partly similar.   "
214667|NCT00653692|"     This project examines fetal neurobehavior and maternal physiology in poly-drug dependent     women. This study also evaluates infant neonatal abstinence syndrome, infant neurobehavior     and vagal tone in the post-partum period.   "
214668|NCT00653705|"     The aim of our study is to assess the effect of daily consumption of yogurt containing     probiotic bacteria BB12 on the health and growth of healthy children 12-48 months of age in     out of home child care.   "
214669|NCT00653718|"     In 2005, the EBCIG demonstrated the efficacy of tamoxifen in improving overall survival in     hormone receptor positive breast cancers. However, tamoxifen shows partial estrogen agonist     activity, which is responsible for the drug's detrimental effects such as endometrial     carcinoma, thromboembolism, and tamoxifen resistance. More recently, aromatase inhibitors     have been shown to be superior to tamoxifen in the metastatic and adjuvant settings. The ATAC     trial demonstrated improved disease-free survival (DFS) for 5 years of anastrozole compared     to 5 years of tamoxifen 3. The BIG 1-98 trial results demonstrated that after a median     follow-up of 25.8 months, letrozole improved DFS and distant DFS when compared to tamoxifen.     Based on these results, adjuvant hormonal therapy with Aromatase Inhibitors (AI) has become     the preferred therapy for post-menopausal woman.      However, AI therapy is also associated with toxicities that merit in-depth studies, one of     them being an increase in musculoskeletal pain. In the ATAC trial, at a median follow-up of     5.7 years, arthralgia was significantly higher (35.6% vs. 29.4%) and fractures were also     increased (11.0% vs. 7.7%) when anastrozole was administered for 5 years following surgery     with or without chemotherapy 3. The incidence of arthralgia was also significantly higher in     the MA-17 trial, with 25% of patients receiving letrozole developing arthralgia compared with     21% in the placebo group following 5 to 6 years of tamoxifen 5.      Traditionally in cancer clinical trials, the reporting of musculoskeletal pain has been based     on the Common Terminology Criteria for Adverse Events, which covers a wide range of     symptoms and does not facilitate the documentation of a pain syndrome in a specific manner.     Therefore, there is a need to design a study that will describe the nature of the pain     associated with the administration of AI therapy using tools that have been validated for     capturing a multidimensional phenomenon such as pain.   "
214670|NCT00653731|"     The purpose of this study is to determine whether the interventions of Snoezelen, structured     reminiscence therapy and 10-minutes activation are effective to reduce apathy in long term     care residents with dementia.   "
214673|NCT00653770|"     This is a Phase I study whose primary outcome is to assess the safety of a new tuberculosis     vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost     regime, to healthy volunteers, who have previously been vaccinated with BCG. The secondary     outcome is to assess the cellular immune response in the same population. The trial consists     of 36 subjects in 3 groups. The first group will be vaccinated with FP85A alone, the second     group will be vaccinated with MVA85A followed by FP85A 28 days later and the third group will     be vaccinated with FP85A followed by MVA85A 28 days later.   "
214674|NCT00653783|"     The overall goal of PROBE is to evaluate the feasibility and potential utility of three     markers (alpha-synuclein, transcriptomic profiles and olfactory function) to determine the     risk or prognosis of PD.   "
214675|NCT00653796|"     This study was designed to assess whether co-administration of ezetimibe 10 mg with     atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with     atorvastatin 10 mg alone for reducing LDL-concentrations.   "
214676|NCT00653809|"     The goal of this study is to examine the activation of markers of endothelial and     cardiovascular dysfunctions, from women with high-risk pregnancies. Information from this     study will hopefully provide enough information to determine a link between race, the advent     of high risk pregnancies and cardiovascular markers. With this information it might be     possible to intervene with approved pharmacological treatments.   "
214677|NCT00653822|"     The objective of this study is to compare the pharmacokinetic and pharmacodynamic properties     and safety profile of alefacept in Caucasian and Japanese healthy subjects   "
214678|NCT00653835|"     This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg     will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C     concentrations when administered for 6 weeks.   "
214679|NCT00653848|"     As docetaxel is proven to be effective in late stages of prostate cancer with a large tumour     burden it should be effective in primarily treated intermediate and high risk prostate cancer     as an adjuvant treatment after radiotherapy to prevent early relapse. This will therefore be     tested in a randomised phase III trial where patients will be randomized either to docetaxel     or surveillance   "
214680|NCT00653861|"     Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™     without Lidocaine for procedural pain in the treatment of nasolabial folds.   "
214681|NCT00653874|"     Objectives: Bilirubin measured by transcutaneous bilirubinometry (TcB) is a reasonably     accurate estimate of serum total bilirubin (STB). Observational studies indicate that     replacing clinical assessment of bilirubin (CaB) with TcB may result in reduced need for     blood sampling for STB estimation. Objective of this study was to determine if routine use of     transcutaneous bilirubinometry decrease the need for blood sampling for confirmation of STB     in healthy term and near term neonates?      Study design: Study was conducted as a randomized controlled trial at a tertiary care     neonatal unit. Healthy neonates born at 35 or more completed weeks of gestation were eligible     for enrolment if they had clinically evident jaundice during first week of life. In each     enrolled neonate, level of jaundice was assessed by two methods - CaB followed by TcB     (BiliCheck®, SpectRx Inc, Norcross, GA). By random allocation method, one of these estimates     was used for deciding the need for blood sampling to confirm STB. Need for blood sampling was     defined to be present if the bilirubin assessed by the allocated method exceeded 80% of     age-specific cut-off for phototherapy as per American Academy of Pediatrics 2004 guidelines.     Study had ethics clearance and written informed consent was obtained from parents.   "
214682|NCT00653887|"     Looking for a modification of the cortical excitability of the motor area corresponding to     the external anal sphincter after biofeedback sessions.   "
214683|NCT00653900|"     A large number of patients are currently on Antiplatelet inhibition using aspirin or Plavix     therapy (A Thieno pyridine - ADP mediated platelet inhibitor). A group of these patients     often require Cardiac and/or Vascular surgical procedures. These patients are at a higher     risk for perioperative bleeding complications and higher re-operation/re-exploration for     bleeding and subsequent blood product transfusions.      The aim of this protocol is to assess platelet function via the Verify Now device prior to     surgery. The Verify Now device requires a small drop of fresh blood for each sample and is an     FDA approved device.      Our initial goal is to establish if a certain degree of platelet function abnormality can     predict a higher bleeding complication or higher transfusions (Phase I, 20 patients). This     initial study will allow us to determine a sample size for Phase II. Phase II will maintain     the same protocol, however after completion of Phase I, a more accurate sample size     determination can be made. Additionally, we want to establish if knowledge of platelet     dysfunction will change procedure technique or preparation to lower bleeding and/or lead to     cancellation/rescheduling of procedure (Phase III).      Participants will be those patients who are taking plavix and are undergoing vascular or     cardiac surgery. They will undergo a platelet function evaluation measured as Platelet     Response Unit (PRU) via the verify now device on admission/pre surgery. This test involves     taking 1 drop of blood from the patient, one time, before the procedure. The Verify Now     device is FDA approved.      Perioperative bleeding will be assessed by absolute drop in hematocrit immediate post-op     compared to the immediate preoperative value. An additional discharge hematocrit will be used     if no blood products have been used during the initial hospital stay. Hematocrit evaluation     via a complete blood count is a part of standard patient care. Additionally, utilization of     blood products (factors, PLT, PRBC's, etc.) will be assessed.      In order to conduct the research, patients will be identified by reviewing the OR schedule.     All consecutive patients on ASA/Plavix will be mailed a letter in order to introduce them to     the study. The letter provides a phone number to call if the patient does NOT want to receive     a phone call from the investigative staff. This letter is uploaded under item 18-02 of the     study application. If patients do not call the office, then the investigative staff will call     the potential participants to introduce the study. Final consent will be completed in PACU on     arrival at the hospital for planned surgical procedure.      A Hematocrit will be performed on the consented patient preoperatively, immediately post-op,     and at discharge. A PRU will be assessed using a few drops of the patients' blood     preoperatively (PACU). Patients' records will be reviewed to assess use of blood products. No     additional follow up is required.      Patients' care will be no different than current standard of care, other than the 1 verify     now test, which is done before the procedure.   "
214684|NCT00653913|"     This study was designed to evaluate the pharmacokinetic interaction and safety of     coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male     subjects or adult male subjects having no obvious disease other than high cholesterol levels.   "
214685|NCT00653926|"     The primary aim of this study is to evaluate if intra- and postoperative administration of     ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay.     Secondary end-points are morphine consumption, pain intensity and side effects. In an attempt     to assess the safety of this technique, knee function and patient satisfaction scores are     assessed up to 6 months after surgery.   "
214703|NCT00654160|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when     given together with fluorouracil and leucovorin in treating patients with advanced     gastrointestinal cancer.   "
214686|NCT00653939|"     The purpose of this study is to determine the safety, tolerability and efficacy of     combretastatin A4 phosphate (CA4P), also known as fosbretabulin, in combination with     bevacizumab (Avastin), carboplatin and paclitaxel in patients with chemotherapy naïve     non-small cell lung cancer (NSCLC). This is a randomized parallel arm study. All participants     will receive carboplatin, paclitaxel and bevacizumab, and half will additionally receive     CA4P. Patients who complete the first 6 cycles of therapy and have not experienced disease     progression will receive maintenance therapy with bevacizumab alone or with bevacizumab plus     CA4P.      The rationale for this study is the potential additive or synergistic actions of vascular     disrupting agents like CA4P with anti-angiogenic agents like bevacizumab.   "
214687|NCT00653952|"     The objective of this study is to compare the efficacy and safety of CAELYX versus Paclitaxel     HCl in patients with epithelial ovarian carcinoma following failure of first-line,     platinum-based chemotherapy. The primary endpoint is time to progression (TTP) following     treatment with either CAELYX or Paclitaxel HCl; the secondary endpoints are response rates,     time to response, duration of response,quality of life assessment, and survival following     treatment with either CAELYX or Paclitaxel HCl. Up to a total of 438 protocol-eligible     patients with epithelial ovarian carcinoma following failure of first-line, platinum-based     chemotherapy will be enrolled in order to obtain 350 evaluable patients.   "
214688|NCT00653965|"     The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin     with 6 weeks of treatment with Atorvastatin in Hispanic subjects with hypercholesterolemia   "
214689|NCT00653978|"     The aim of the present study was to compare the effect of unilateral versus bilateral     stenting in patients with malignant hilar obstruction.   "
214690|NCT00653991|"     This study will evaluate the effectiveness of an interactive virtual environment computer     game in reducing risky sexual behaviors among men who have sex with men.   "
214691|NCT00654004|"     Several hormones involved in body weight regulation increase the subject's ability to burn     fat for energy. The purpose of this study is to investigate how burning fat for energy may     affect those hormones and body weight in children. The study will also determine if eating a     diet higher in protein alters the amount of fat you burn and how these hormones control body     weight.   "
214692|NCT00654017|"     The study was done to evaluate the efficacy, safety, and tolerability of orally administered     sildenafil taken as needed about one hour before sexual activity after a 10-week period in     male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.   "
214693|NCT00654030|"     Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective     immune response to kill tumor cells.      The Purpose of this study is to evaluate the effects of a lung cancer vaccine in patients     with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial     definitive therapies.   "
214694|NCT00654043|"     To compare the single-dose bioavailability of Torsemide tablets with Demadex   "
214695|NCT00654056|"     The purpose of the study is to investigate some of the mechanisms behind severe insulin     resistance and to determine the dose response to insulin in patients with type 2 diabetes     mellitus.   "
214696|NCT00654069|"     The purpose of this study is to determine whether oxycodone HCl and niacin are effective in     the treatment of pain following bunionectomy surgery.   "
214697|NCT00654082|"     To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as     required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED)     associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL)     of these patients.   "
214698|NCT00654095|"     Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin     in participants with hypercholesterolemia who have not reached low density lipoprotein     (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase     inhibitors.   "
214699|NCT00654108|"     Enterotoxigenic Escherichia (E.) coli (ETEC) bacteria are the main cause of traveler's     diarrhea and are significant pathogens affecting children and elderly individuals of     developing countries. The purpose of the study is to determine the safety of the ETEC-Cholera     vaccine and the body's ability to protect itself against ETEC and cholera infection after     receiving the vaccine. The study will enroll a total of 64 healthy volunteers, 18 to 45 years     old at the Cincinnati Children's Hospital. The study will provide increasing doses of the     vaccine or placebo (inactive substance) to 4 groups consisting of 16 participants each.     Participants will remain in the inpatient unit for observation for about 11 days. All     subjects will be treated with Cipro, an antibiotic, for 5 days. Study procedures include:     blood samples, vital signs, physical examinations, and stool samples. Volunteers will be     involved in the study for about 8 months including telephone contacts.   "
214700|NCT00654121|"     Prophylactic administration of metabolically active insulin can prevent or delay clinical     onset of diabetes in a high risk group of nondiabetic siblings as defined by positivity for     autoantibodies against IA-2 (IA-2-A).   "
214701|NCT00654134|"     The purpose of this study is to determine the inflammatory response to 20,000 endotoxin units     (EU) of CCRE (Clinical Center Reference Endotoxin) inhalation in a cohort of healthy     volunteers. Preferably these subjects will have participated in ozone exposure studies,     allowing a direct comparison of their responses to both endotoxin and ozone. Additionally,     cardiovascular endpoints will be investigated with the CCRE exposure.   "
214702|NCT00654147|"     A prospective, randomized, open-label pilot study to assess virologic suppression and     immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the     protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and     two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.      Immunology Substudy added to determine the kinetics of recovery of CD4 T cells and     subpopulations (regulatory T cell [T regs], TH-17 and TH1) after treatment initiation with     Raltegravir based regimens and their relationship with functional CD8 T cells and if     Raltegravir containing therapies leads to decreases in markers of gut microbial translocation     and of cellular and soluble markers of immune activation.   "
214805|NCT00661570|"     The purpose of this study is to investigate long-term clinical feasibility of a new voice     prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation     after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life,     and reason for replacement.   "
214706|NCT00654199|"     The purpose of this study is to:        1. assess the existence of inter-ventricular and intra-ventricular asynchrony in cardiac          surgery patients before (PRE) and after cardiopulmonary bypass surgery (POST)        2. investigate whether a modification of usual pacing practices (RA-LV pacing) can achieve          inter- and intra-ventricular synchrony and improve heart function, as evaluated by          hemodynamic and echocardiographic indexes, when compared with the patient's native          rhythm (normal sinus rhythm (SR), or conventional pacing modes   "
214707|NCT00654212|"     Objective: Whether temporary endoscopic decompression by Self-expanding metal stents (SEMS)     could allow these patients to undergo successful laparoscopic resection (endo-laparoscopic     approach) has never been previously studied. This randomized trial aims to compare this     approach with emergency open surgery in the management of obstructing left-sided colon     cancer.   "
214708|NCT00654225|"     The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin     with 6 weeks of treatment with Atorvastatin in South Asian subjects with     hypercholesterolemia.   "
214709|NCT00654238|"     The goal of this study is to determine the activity of sorafenib in patients with advanced     (metastatic or recurrent) thyroid cancer.   "
214710|NCT00654251|"     Measuring the various difficulties patients with spinocerebellar ataxias (SCA) report in an     accurate manner is important to be able to test any therapy that may be developed. As basic     research identifies some therapy of this type, clinicians are planning studies that can     either prove or disprove that such treatments actually have an effect. Walking problems and     problems with eye movements that can give rise to visual complaints are common in the SCA's.      Existing neurological scales such as the SARA are based on the usual neurological     examination items that can carry a degree of subjective bias. Also the intervals between     numbers on such scores often do not carry the same weight so that the difference between a     score of 1 and 2 may not be equal to difference between 2 and 3. Lastly, such scales done in     the clinic setting capture only a brief period of a patient's day. We propose that     examination of home based gait monitoring, timed tests of motor function and quantitative     measures of visual problems in patients with SCA are more useful in measuring the disability     in these patients.   "
214711|NCT00654264|"     This is an unblinded pilot study comparing (against a randomized control day without water     immersion) the diuretic and natriuretic effects of water immersion in patients with right     heart failure.   "
214712|NCT00654277|"     To compare the single-dose bioavailability of Ondansetron 8 mg oDT and Zofran 8 mg ODT   "
214713|NCT00654290|"     Atrial fibrillation is the most common arrhythmia post coronary bypass surgery, currently     B-blockers are the class I indication to prevent AF post CABG. We decide to evaluate use of     propranolol and amiodarone separately and together to find a better prophylaxis for AF     peri-CABG   "
214714|NCT00654303|"     The purpose of this study is to assess the long term safety of Crestor.   "
214715|NCT00654316|"     Tuberculosis (TB) kills about three million people annually. It is estimated that one third     of the world's population are latently infected with Mycobacterium tuberculosis (M.tb).     Multi-drug resistant strains of M.tb, and co-infection with M.tb and HIV present major new     challenges. The currently available vaccine, M. bovis BCG, is largely ineffective at     protecting against adult pulmonary disease in endemic areas and it is widely agreed that a     new more effective tuberculosis vaccine is a major global public health priority1. However,     it may be unethical and impractical to test and deploy a vaccine strategy that does not     include BCG, as BCG does confer worthwhile protection against TB meningitis and leprosy. An     immunisation strategy that includes BCG is also attractive because the populations in which     this vaccine candidate will need to be tested will already have been immunised with BCG.      M.tb is an intracellular organism. CD4+ Th1-type cellular responses are essential for     protection and there is increasing evidence from animal and human studies that CD8+ T cells     also play a protective role2. However, it has generally been difficult to induce strong     cellular immune responses in humans using subunit vaccines. DNA vaccines induce both CD4+ and     CD8+ T cells and thus offer a potential new approach to a TB vaccine. DNA vaccines encoding     various antigens from M. tuberculosis have been evaluated in the murine model, and to date no     DNA vaccine alone has been shown to be superior to BCG.      A heterologous prime-boost immunisation strategy involves giving two different vaccines, each     encoding the same antigen, several weeks apart. Such regimes are extremely effective at     inducing a cellular immune response. Using a DNA- prime/MVA-boost immunisation strategy     induces high levels of CD8+ T cells in animal models of malaria and HIV5, and high levels of     both CD4+ and CD8+ T cells in animal models of TB. BCG immunisation alone induces only CD4+ T     cells in mice. A prime-boost strategy using BCG as the prime and a recombinant MVA encoding     an antigen from M.tb that is also present in BCG (antigen 85A: 'MVA85A') as the boost,     induces much higher levels of CD4+ T cells than BCG or MVA85A alone. In addition, this regime     generates specific CD8+ T cells that are undetectable following immunisation with BCG alone.   "
214716|NCT00654329|"     A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an     α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.   "
214717|NCT00654342|"     The technique of sentinel lymph node mapping in patients with colon cancer varies among     reports, and the optimal method remain to be established. The purpose of this study was to     determine the optimal injection technique for sentinel lymph node mapping for colon cancer.   "
214718|NCT00654355|"     The purpose of this research study is to better understand how the study drug works when     people use it to treat atopic dermatitis.   "
214719|NCT00654368|"     The purpose of the study is to evaluate the use of etanercept in the treatment of rheumatoid     arthritis with or without methotrexate treatment over a 24 month period   "
214720|NCT00654381|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and     voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with     insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension     treatment to 52 weeks.   "
214721|NCT00660270|"     To describe the overall survival and disease-free survival in pancreatic cancer patients     treated with adjuvant chemoradiation with cisplatin, continuous infusion 5FU and interferon     alpha followed by gemcitabine.      To describe the toxicities associated with adjuvant chemoradiation with cisplatin. 5FU and     interferon alfa followed by gemcitabine in patients with pancreatic cancers.   "
214722|NCT00660283|"     To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer     implantation, followed by concomitant limited field radiation therapy and temozolomide,     followed by dose dense temozolomide in subjects undergoing initial surgery for     newly-diagnosed high grade glioma.   "
214774|NCT00661167|"     The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for     recurrence or unresectable gastric cancer patients who have received one prior regimen     containing fluoropyrimidine and developed disease progression or recurrence.   "
214723|NCT00660296|"     CO2 insufflation instead of air for colonic distension in colonoscopy is considered to reduce     pain after and during colonoscopy. There is limited data, that Co2 is similar effective in     sedated patients. Furthermore it had not been investigated if patient's compliance for     participating in cancer screening could be improved by using Co2.      The aim of the study is to assess postoperative pain and satisfaction after colonoscopy by     comparing C02 with air.   "
214724|NCT00660309|"     The study objective was to assess the effect of single and multiple doses of aliskiren on     renal plasma flow, glomerular filtration rate and to compare the effects of single and     multiple doses of aliskiren versus captopril or irbesartan on renal blood flow, glomerular     filtration rate, and retinal blood flow in patients with type 2 diabetes mellitus.   "
214725|NCT00660322|"     Asthma is the most common chronic disease of childhood and a major cause of morbidity in the     United States. If asthma symptoms are controlled, a child with asthma can stay well and lead     a normal life. Daily use of inhaled steroids controls symptoms and reduces morbidity and     emergent health care utilization in children with persistent asthma, and is safe for     long-term use. However, inhaled steroids are underused in community asthma care.      The Telephone Asthma Program (TAP) is a series of brief, telephone calls with a trained coach     to help the parent manage the child's asthma care. The coach will teach self-management     skills, help the parent to use the child's asthma medicines effectively, provide support and     remind the parent to go for follow-up care with the pediatrician. We hypothesized that the     Telephone Asthma Program will reduce the incidence of acute exacerbations of asthma that     require emergent care, improve the quality of life of children with asthma and their parents,     and increase the daily use of inhaled steroids in children with persistent asthma. We     evaluated the Telephone Asthma Program in a randomized controlled trial involving 362     children aged 5 to 12 years old cared for by community pediatricians. Eligible children were     randomized to the TAP program or usual care by their pediatrician.   "
214726|NCT00660335|"     The purpose of this study is to evaluate the safety and effectiveness of RG1068 (synthetic     human secretin) with MRCP in subjects with abnormalities of the pancreas.   "
214727|NCT00660348|"     RATIONALE: Giving medications in different ways may change their effectiveness in controlling     pain. It is not yet known whether intrathecal therapy is more effective than standard therapy     in controlling pain in patients with pancreatic cancer.      PURPOSE: This randomized clinical trial is studying standard pain control to see how well it     works compared with intrathecal therapy in controlling pain in patients with locally     advanced, unresectable, or metastatic pancreatic cancer.   "
214728|NCT00660361|"     Human immunodeficiency virus/Hepatitis B virus (HIV/HBV) co-infections are frequently     observed due to shared routes of transmission, with reported figures indicating 6-9% of     HIV-infected individuals in developed countries are chronically infected with HBV. HIV     infection impacts on the natural progression of HBV infection, increasing levels of HBV     replication and the risk of liver-associated mortality. Liver diseases associated with HBV     are affected by the antiviral drugs used for HIV infection (toxic side effects), the current     immune function in the patient, by improvements in the immune system brought about by control     of the HIV infection, and by the development of resistance to the antiviral agents used for     both the hepatitis B and the HIV infection. Tenofovir (TDF) is a newer antiviral drug that is     frequently used for HIV infection and is also highly active against hepatitis B; however it     is still unknown whether resistance to TDF will eventually develop and how this will affect     the long-term outcomes   "
214729|NCT00660374|"     This trial is conducted in South America. This trial aims for a comparison of the safety and     efficacy of insulin NPH and a new insulin formulation on blood glucose control.   "
214730|NCT00660387|"     The primary objective of this study was to demonstrate the superiority of levodopa -     carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12     weeks.   "
214731|NCT00660400|"     The purpose of this study is to find out if treating people who have high-risk     myelodysplastic syndrome (MDS) with 5-Azacitidine (Vidaza) prior to their allogeneic     hematopoietic cell transplant (HCT) is helpful in preventing their myelodysplastic syndrome     from coming back.      In previous research, 5-Azacitidine appeared to help the bone marrow of a patient with MDS     begin to function more normally. This means bone marrow cells can grow and do their work the     way they were meant to. 5-Azacitidine is approved by the Food and Drug Administration (FDA)     for the treatment of MDS. The effect of 5-Azacitidine in patients receiving hematopoietic     cell transplants have not been studied.   "
214732|NCT00660413|"     The purpose of this study was to compare two methods for neuromuscular monitoring,     acceleromyography and mechanomyography for establishing the dose-response relationship and     the potency of a neuromuscular blocking agent using rocuronium as an example. We hypothesized     that there would be no significant difference between potencies estimated using     acceleromyography and mechanomyography.   "
214733|NCT00660426|"     Dose escalation of oxaliplatin, gemcitabine and capecitabine in the treatment of patients     with advanced gastrointestinal malignancies and other solid tumors.   "
214734|NCT00660439|"     This study compares Narrative Exposure Therapy with a Waiting list control group, both     consists of traumatized patients with diagnosed Posttraumatic Stress Disorder. The main aim     is to investigate if the patients psychiatric symptoms and levels of the stress hormone     cortisol will improve more after Narrative Exposure Therapy than the Waiting list (i.e. no     intervention).   "
214735|NCT00660452|"     A phase III study to assess the efficacy and safety of sublingual immunotherapy with STALORAL     dust mites solution compared with placebo for reduction of asthma symptoms.   "
214736|NCT00660465|"     The purpose of this study is to explore how arterial PaCO2 effect regional Blood Oxygen Level     Dependent (BOLD) signal, and indirectly the brain regional O2 level .   "
214738|NCT00660491|"     Postprandial lipemia and exercise oppose each other in terms of cardiovascular risk, however     the mechanism of their interaction is not well understood.      Therefore we want to study vascular function, as assessed by brachial artery (BA) flow     mediated dilation (FMD), in healthy men before and after a high fat meal (HFM) preceded     (16-18 hrs) by rest, a single bout of continuous moderate intensity exercise (CME), and high     intensity interval exercise (HIIE).   "
214897|NCT00662766|"     The study was performed to investigate the effects of the consumption of black currant seed     press residues, which were baked into bread.   "
214739|NCT00660504|"     This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from     growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with     cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease     small cell lung cancer The subject, who is randomized to AP group may be involved into a     pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.   "
214740|NCT00660517|"     The purpose of this study is to determine if two allergy medications (azelastine and     fluticasone) are more effective than placebo or either medication alone (azelastine or     fluticasone)   "
214741|NCT00660530|"     Patients with end-stage renal disease (ESRD) commonly develop hyperphosphatemia due to the     loss of excretory function of the kidney. This in turn may lead to the development of     secondary hyperparathyroidism (SHPT) and renal osteodystrophy. Lanthanum carbonate, a     phosphate binding agent, works by releasing lanthanum ions in the gastrointestinal tract to     bind dietary phosphate and is effective in the management of hyperphosphatemia and in     preventing secondary hyperparathyroidism.      Patients taking lanthanum carbonate as part of their phosphate binder therapy are counseled     to chew the tablets completely before swallowing, with or immediately after meals. However,     ESRD patients who are intubated or are receiving enteral tube feedings are unable to chew the     lanthanum carbonate tablets. For such patients, medications are commonly crushed and     administered through a gastrostomy tube (G-tube). Some patients may also prefer to crush the     lanthanum carbonate tablets and mix it with food instead of chewing. To date, it is not known     if crushing the lanthanum carbonate tablets prior to administration and taking it with food     will be as efficacious as chewing it.      The objective of this study is to compare the efficacy of phosphate binding between chewed     and crushed lanthanum carbonate in patients undergoing hemodialysis.   "
214742|NCT00660543|"     This pilot clinical trial studies how a magnetic resonance imaging (MRI) study with     ferumoxytol works as a contrasting agent in assessing early response in patients with     glioblastoma multiforme receiving temozolomide and radiation therapy. Ferumoxytol is a very     small form of iron particles that are injected into the body and taken up by certain tissues     which may make these tissues easier to see during imaging. Diagnostic procedures, such as an     MRI study with ferumoxytol, may help measure a patient's response to earlier treatment.   "
214743|NCT00660569|"     The purpose of this study is to identify the potential issues during short and mid term     utilization of Pulmicort hydro fluoroaklane (HFA) pressurized metered-dose inhaler (pMDI)and     describe associated factors.   "
214744|NCT00660582|"     The Nordic FLOX-regime consists of a combination of bolus 5-FU, leukovorin and oxaliplatin     (Eloxatin®). Cetuximab (Erbitux®) is an antibody against the epidermal growth factor receptor     (EGFR). The combination of FLOX and weekly Erbitux has been investigated in the Nordic VII     study where 571 patients were randomized to FLOX (regime A) or FLOX + Erbitux (regime B or     C). Effect-data has not yet been published but the combination is well tolerated, and other     studies have shown that Erbitux administered with chemotherapy seem to be more efficient than     chemotherapy alone.      The main purpose with this study is to investigate the effect of FLOX and Erbitux given every     second week as first line treatment for patients with metastatic colorectal cancer and K-RAS     wildtype tumor.      The latest accessible data regarding treatment towards EGFR and K-RAS mutations shows that     patients with K-RAS wildtype responds better to treatment than patients with K-RAS mutations.   "
214745|NCT00660595|"     This pilot trial in Finland is designed to evaluate in a randomized fashion change of     agitation in acute schizophrenic patients (Schizophrenia or Schizoaffective psychosis or     Schizophreniformic psychosis)Diagnostic and Statistical Manual (DSM - IV) with the first     visits on days 1, 2, 4 or 5 and 7 ± 1.   "
214746|NCT00660803|"     Characterize the demographic and clinical features, as well as the main treatment results,     among patients with advanced breast cancer treated with fulvestrant in Brazil.   "
214747|NCT00660816|"     RATIONALE: Pemetrexed disodium and erlotinib hydrochloride may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. It is not yet known whether giving pemetrexed     disodium or docetaxel together with erlotinib hydrochloride is more effective than giving     pemetrexed disodium or docetaxel alone in treating non-small lung cancer.      PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium or     docetaxel together with or without erlotinib hydrochloride works in treating patients with     stage IIIB or stage IV non-small cell lung cancer.   "
214748|NCT00660829|"     The Purpose of this study is to determine if one allergy medication (0.15% azelastine     hydrochloride) is more effective than Placebo alone.   "
214749|NCT00660842|"     The purpose of this study is to study efficacy and the effects on quality of life in women     with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and     paclitaxel compared to those treated with standard every 3 weeks schedule of the same     chemotherapy.   "
214750|NCT00660855|"     The objectives of this study were to assess the analgesic efficacy and safety of     parecoxib/valdecoxib on post-laparoscopic surgery analgesia.   "
214751|NCT00660868|"     Signal processing in the olfactory neuron could be influenced by inhibition of enzymes like     phosphodiesterase. Pentoxifylline is a unspecific phosphodiesterase inhibitor. The hypothesis     is that pentoxifylline could lead to increased sensitivity to odors.   "
214752|NCT00660881|"     The primary objective of the study is to assess the safety of epratuzumab in patients with     SLE.   "
214803|NCT00661544|"     1. To evaluate the toxicity and safety of a combination of arsenic trioxide with ascorbic          acid and high-dose Melphalan in patients with multiple myeloma        2. To evaluate the efficacy of a combination of arsenic trioxide with ascorbic acid and          high-dose Melphalan in patients with multiple myeloma        3. To determine the effects of arsenic trioxide on melphalan pharmacokinetics   "
214772|NCT00661141|"     This trial will evaluate if fomepizole (4-methylpyrazole)can treat symptoms associated with     alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) Deficiency, an inherited     metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath     and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol.     Long-term, serious health risks have been associated with repeated exposure to acetaldehyde,     a carcinogen, among ALDH2-deficient individuals.   "
214753|NCT00660894|"     RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. It is not yet known whether giving tegafur-uracil together with     leucovorin is more effective than giving S-1 in treating patients with stage III colon     cancer.      PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with     leucovorin to see how well it works compared with giving S-1 in treating patients with stage     III colon cancer that has been completely removed by surgery.   "
214754|NCT00660907|"     This study is being carried out to see if dapagliflozin as an addition to metformin is     effective and safe in treating patients with type 2 diabetes when compared to glipizide     (sulphonylurea) as an addition to metformin treatment.   "
214755|NCT00660920|"     The purpose of this study is to determine the maximum tolerated dose or a recommended dose of     oral AP24534 in a defined schedule in patients with refractory or advanced chronic     myelogenous leukemia and other refractory hematologic malignancies.   "
214756|NCT00660933|"     The aim of the study is to compare the effect of intravenous versus oral iron in women with     severe postpartum anemia.   "
214757|NCT00660946|"     To determine whether point of care (POC) International Normalized Ratio (INR) test results     correlate with plasma INR measures in hemodialysis patients.   "
214758|NCT00660959|"     The present study is designed to confirm and extend the observation from previous studies     that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with     SIADH.   "
214759|NCT00660972|"     The HIV integrase inhibitor, raltegravir (RAL), which was recently approved by the FDA, has     been shown in several trials to be highly effective. The purpose of this trial is to estimate     the viral load decay rate in treatment-naive HIV infected participants receiving RAL and     emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).   "
214760|NCT00660985|"     Phase 4 commitment pharmacokinetic study to determine systemic exposure to adapalene.   "
214761|NCT00660998|"     Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction   "
214762|NCT00661011|"     The purpose of this study is to determine if radical radiochemotherapy on the mediastinum     after lobectomy can be associated with significant long term survival in patients with     initially unresectable stage III NSCLC responding to induction chemotherapy but in which the     residual disease is too large to be treated by radiotherapy.   "
214763|NCT00661024|"     Some recent studies have shown that intraoperative neuromonitoring (IONM) can aid the     recurrent laryngeal nerve (RLN) identification during thyroid surgery. However, the role of     IONM in reducing the incidence of RLN injury rate and the value of this method in predicting     postoperative RLN function remain controversial. Only a few published series represent level     III of evidence and grade C of recommendation according to the evidence-based criteria     (Sackett's classification, modified by Heinrich). Thus, the aim of this randomized clinical     trial was to compare the impact of RLN visualization versus IONM on their morbidity following     thyroid surgery.   "
214764|NCT00661037|"     The aim of this prospective observational study is to evaluate the safety, over a follow-up     of 2 years, of two strategies, consisting in performing or not performing defibrillation     testing(DT) during first implant of implantable cardioverter defibrillator   "
214765|NCT00661050|"     Complementary and alternative medicine (CAM) is the term for medical products and/or     practices that are not part of the current standard of care. Standard care is what medical     doctors, doctors of osteopathy and allied health professionals, such as registered nurses and     physical therapists, practice. Alternative medicine means treatments that you use instead of     standard ones. Complementary medicine means nonstandard treatments that you use along with     standard ones. The purpose of this study is to determine whether there is any improvement in     symptoms reported by patients with chronic painful bladder syndrome when participating in     alternative medical therapy/ exercise and meditative techniques. The specific alternative     techniques participants will be randomized to in this trial include: Tai Chi instruction or     walking exercise combined with sitting meditation.   "
214766|NCT00661063|"     Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo     in patients with diabetic neuropathic pain   "
214767|NCT00661076|"     This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS +     adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B     patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg     po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a     further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po     daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180     micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free     follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size     is <100 individuals.   "
214768|NCT00661089|"     The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles     around the shoulder is effective in treating shoulder pain and improving function in patients     with shoulder pain and involuntary muscle tightness after a stroke.   "
214769|NCT00661102|"     This 3 arm study will compare the prophylactic effect of topical corticosteroids, Bepantol or     placebo on hand-foot syndrome in patients receiving Xeloda for treatment of metastatic breast     cancer, metastatic colorectal cancer or adjuvant treatment of colorectal cancer. Patients who     have been receiving oral Xeloda for at least 5 days will be randomized to receive     prophylactic treatment with either placebo, topical corticosteroids or Bepantol. The     anticipated time on study treatment is until disease progression or development of hand-foot     syndrome, and the target sample size is 500+ individuals.   "
214770|NCT00661115|"     To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.   "
214771|NCT00661128|"     Sudden cardiac arrest (SCA) is a sudden, unexpected loss of heart function. It is a leading     cause of death, and more than 400,000 people in the United States die each year as a result     of SCA. This study will analyze genetic samples of people who have experienced SCA and people     who have not experienced SCA to determine if there is a genetic basis for SCA.   "
214806|NCT00661583|"     The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs     monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.   "
214776|NCT00661193|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may     kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well erlotinib works when given alone     or together with carboplatin and paclitaxel in treating patients with stage IIIB or stage IV     non-small cell lung cancer.   "
214777|NCT00661206|"     The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy     after DES implantation is not inferior to that of a 12 month therapy.   "
214778|NCT00661219|"     The study will last three months. During the first month of treatment the subject will     receive either 10 mg vardenafil or placebo. After 1 month of treatment the doctor, can choose     to increase the dosage from 10 mg to 20 mg or decrease the dosage to 5 mg. The doctor will     again evaluate, after 2 months of treatment if the subject wants to increase the dosage from     10 mg to 20 mg or, if already done, to continue with the dosage of 20 mg or decrease to 10 mg     or 5 mg. It will not be possible after this point to increase or decrease the dosage for the     rest of the study. The subject will be asked to attend the clinic on four separate occasions     over a period of 3 months. Every visit will last about 1 hour. At the first visit the doctor     will ask the subject about their medical history, and the subject will be given a medical     examination (including your heart rate, blood pressure and weight). The medical examination     will also include an ECG. The subject will be asked to provide a blood and urine sample,     which will be analysed and screened for drugs of potential abuse (e.g.cocaine, narcotics,     sedatives, hypnotics). The subject will then be asked to fill in a questionnaire about their     mood and feelings. The subject qualifies, they will have an interview with a trained mental     health care provider who will assess their level of depression. At the end of the visit, the     doctor will provide the subject with a diary in which they must record details about their     attempts at sexual activity during the next 4 weeks. The subject will be asked to make at     least 4 attempts at sexual intercourse on 4 separate days and to record the attempts in the     diaries. After 4 weeks the subject will return to the clinic. They will be asked to fill in     different questionnaires about their sexuality, mood and feelings, general quality of life,     self-esteem and sexual activity in the last 4 weeks. Two additional blood and urine samples     will be collected. An interview with the trained mental health care provider who will     re-assess their level of depression. At this visit all information collected so far will be     assessed and the doctor will check to see if the requirements to enter the treatment period     are fulfilled. The subject may be excluded from further participation in the study, for     example due to results of the blood analysis or if your level of depression did not meet the     criteria for the study. If the subject is able to participate to the study they will be given     the study drug. At each visit, adverse events will be discussed and whether there is any     change in medicine. Vital signs and ECG will be obtained at visit one, two, five and/or     Premature Termination. At every visit the subject will receive a diary in which they must     record details about their attempts at sexual activity during the period between each visit     and the number of tablets taken. Subjects will also be asked to fill in different     questionnaires about their sexuality, mood and feelings, self-esteem and sexual activity.     Subjects will also be contacted by telephone, at 2, 6 and 10 weeks after starting the study     medication, 24 hours after the last dose of study medication. The doctor will give the study     drug on 3 occasions. Should the subject or doctor prematurely stop trial participation the     subject will be required to return to the clinic for a physical examination, vital signs and     have blood samples and ECG obtained. They will also be asked to fill in different     questionnaires.   "
214779|NCT00661232|"     The purpose of this study is to test the hypothesis of whether contrast enhanced Magnetic     Resonance Imaging can be used to predict improvement of the wall motion in regions of the     heart with abnormal movement following bypass surgery or percutaneous angioplasty in various     institutions across three continents.   "
214780|NCT00661245|"     The TOGA® trial is a prospective, multi-center, randomized sham-controlled trial designed to     determine the safety and effectiveness of the TOGA System for the treatment of morbid     obesity. The study will also determine the effect of the treatment on co-morbidities and     quality of life.      Subjects will be blinded to treatment or sham. Sham arm may crossover to TOGA treatment at 12     months.   "
214781|NCT00661258|"     This study focuses on collecting and analyzing quantitative data related to adherence to     antiretroviral treatment from patients in Dali, China, over a one-year time-frame and     generating preliminary data on an intervention designed to improve adherence to     antiretroviral treatment among the study population.   "
214782|NCT00661271|"     Our uncontrolled study of mindfulness-based stress reduction (MBSR) for urban youth suggests     benefits in mental health and quality of life outcomes. To evaluate further the specific     effects of MBSR, we are conducting a small randomized controlled trial of the MBSR program     compared with a health education program.   "
214783|NCT00661284|"     A 52-week follow up study to investigate the duration of maintenance of efficacy in patients     with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment   "
214784|NCT00661297|"     Study to investigate the efficacy and safety of Vardenafil   "
214785|NCT00661310|"     The purpose of this study is to measure the effects of an enhanced service where a     pharmacists is part of the healthcare team on the ward (focusing on drug-related problems and     transferring information between primary and secondary care). Primary outcome measure is     visits to hospital during a 12-month follow-up period, and the population is patients 80     years and older.   "
214786|NCT00661323|"     Magnetic resonance imaging (MRI) and echocardiography are two imaging methods that are used     to obtain pictures of the heart and assess heart function. This study will evaluate a new,     four-dimensional echocardiography approach of obtaining heart images to determine if it is as     effective at evaluating heart function as MRI.   "
214804|NCT00661557|"     In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a     previous study (whose objectives & outcome measures are presented in a separate protocol     posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation     technology.      These subjects will be compared to subjects vaccinated with the new vaccine, but who were not     previously vaccinated with a meningococcal polysaccharide vaccine.   "
248527|NCT01108458|"     A phase 2 study combining pertuzumab with erlotinib for patients with gemcitabine refractory     pancreatic adenocarcinoma   "
214787|NCT00661336|"     RATIONALE: Buthionine sulfoximine may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of     tumor cells. The tumor is said to be resistant to chemotherapy. Giving buthionine sulfoximine     together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed.      PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when     given as an isolated limb infusion together with buthionine sulfoximine in treating patients     with persistent or recurrent stage III malignant melanoma.   "
214788|NCT00661349|"     In retrospective studies, acceleration of hepatic fibrosis has been seen in Nevirapine (NVP)     treatment when compared with Protease Inhibitors (PI) boosted with ritonavir treatment in     patients with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) infection. The     high incidence in our country of HIV-HCV co-infection, the availability of a new Kaletra     (LPV/r) formulation (more convenient and better tolerated than soft capsules) as well as the     possibility of analyzing hepatic fibrosis evolution in a fast and bloodless way, make     attractive a study that, in a prospective way, could check the benefits of substituting NVP     by LPV/r on hepatic fibrosis in this community.   "
214789|NCT00661362|"     Saxagliptin is a new investigational medication being developed for treatment of type 2     diabetes. This study is designed to evaluate the efficacy and safety in adult patients who     have inadequate glycaemic control when treated with metformin in addition to diet and     exercise.   "
214790|NCT00661375|"     To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with     unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine     containing regimen.   "
214791|NCT00661388|"     This single arm study will assess the efficacy and safety of subcutaneous methoxy     polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin     levels in predialysis patients with renal anemia who are not currently treated with     erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous     injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. The anticipated     time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
214792|NCT00661401|"     Objective: Measure serum IgG antibody to Streptococcus pneumoniae serotypes 1, 3, 5, 6B, 9V e     14, Haemophilus influenzae type b and tetanus toxoid in patients with primary antibody     deficiencies who were treated with subcutaneous immunoglobulin infusions.   "
214793|NCT00661414|"     The purpose of this study is to determine the safety, tolerability and highest dose of ASONEP     that can safely be administered to patients with cancer who are no longer being helped by     standard treatments.   "
214794|NCT00661427|"     The purpose of this study is to find out what effects, good and/or bad, 2 doses of Cetuximab     will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not     work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we     will try to determine if 500 mg/m2 and 750 mg/m2 given every other week can work better. We     do not know if it will help. We can use what we learn from this research study to help other     people with the same disease.   "
214795|NCT00661440|"     The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in     the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition,     a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be     included; this subgroup will be analyzed in an exploratory manner only.   "
214796|NCT00661453|"     This is a multi-center trial to test safety and evaluate early treatment intervention with     valproic acid and carnitine in moderating SMA symptoms of Type I infants.   "
214797|NCT00661466|"     The purpose of this study is to determine whether the CollaRx Bupivacaine Implant     (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication     needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.   "
214798|NCT00661479|"     This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on     visual function of a single injection of Brimonidine intravitreal implant in one eye of     patients with Retinitis Pigmentosa.   "
214799|NCT00661492|"     To determine the time to progression produced by the combination of Novantrone (mitoxantrone)     and Erbitux (cetuximab) versus Novantrone alone in metastatic AIPC patients previously     treated with docetaxel-based chemotherapy. TTP is defined as time from the start of treatment     date to the date the patient is first recorded as having disease progression, even in     patients who discontinue study treatment early due to toxicity.   "
214800|NCT00661505|"     This single arm study will assess the efficacy, safety and tolerability of once-monthly     administration of intravenous Mircera for the maintenance of hemoglobin levels in     hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous     injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time     on study treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
214801|NCT00661518|"     Rationale: Aneurysm development, progression and rupture are characterised by extensive     inflammation, dominated by the infiltration of T-cells, B-cells and macrophages. Recent     studies into the pathophysiology of aneurysm wall degradation suggest a close relation     between increased mechanical stress and the local activation of infiltrated lymphocytes and     macrophages. The non-invasive detection of aneurysm wall inflammation, using     18-fluorodeoxyglucose positron emission tomography (FDG-PET) might therefore provide valuable     information on the extend of the disease and could clarify the role of mechanical stress on     the propagation of aneurysm wall inflammation.      Objective: Correlation of FDG uptake and in vitro aneurysm wall tensile strength. (primary     objective). The effect of aneurysm sac depressurisation, after endovascular aneurysm repair,     on aneurysm wall inflammation (secondary objective).      Study design: Observational case series (pilot). Study population: Patients scheduled for     conventional (open) and endovascular aneurysm repair.      Main study parameters: Standard uptake value (SUV) measurements to asses FDG uptake in the     aneurysm wall and in vitro aneurysm wall strength (N/mm).      Nature and extent of the burden and risks associated with participation,      benefit and group relatedness: Patients scheduled for conventional (open) or endovascular     aneurysm repair are admitted to the hospital the day before surgery. At that point all     patients will be evaluated using FDG-PET. Although intake of sugar-free liquids is permitted,     glucose intake is restricted 6 hours prior to FDG-PET imaging. One hour after intravenous     injection of 200-220 MBq FDG, whole body emission and transmission images will be acquired.     To determine inflammation markers ( e.g. CRP), blood and urine samples will be collected     prior to the operation and again 6 weeks after surgery. For in vitro aneurysm wall tensile     strength testing wall specimens will be harvested during conventional aneurysm repair.   "
214802|NCT00661531|"     This trial seeks to confirm the response rate for estrace treatment in a patients with     hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine     therapies.   "
214807|NCT00661596|"     Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The     purpose of this national study was to determine if vardenafil is effective in treating     impotent men (erectile dysfunction) and evaluate its influence in self-esteem and     self-confidence. During the visits the patients was asked some questions about erections, and     he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual     activity.   "
214808|NCT00661609|"     The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a     novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor     cell division leading to tumor growth), can reduce tumor sizes in patients with bladder     cancer   "
214809|NCT00661622|"     Patients with uveal melanoma metastatic to the liver will be treated with embolization of the     hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or     normal saline will be injected into one of the liver arteries with an oily contrast dye,     Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge     (embolization). It is hoped with this novel approach that:        -  tumor cells will die due to a loss of their blood supply,        -  local inflammatory reactions induced by GM-CSF will kill remaining tumor cells, and        -  a systemic immune response against tumor cells may develop.   "
214810|NCT00661635|"     To evaluate the analgesic efficacy, general safety, and effects on health outcome measures     and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients     with moderate or severe pain following laparoscopic cholecystectomy surgery.   "
214811|NCT00661648|"     This study evaluated that strict control of perioperative blood glucose following pancreatic     resection by using an artificial pancreas would improve postoperative surgical site     infection.   "
214812|NCT00661661|"     The purpose of this study is to determine the long-term effectiveness and safety of     CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this     study after they have completed participation in another qualifying study of CP-690,550.   "
214813|NCT00661674|"     Opioid medications are commonly used for pain relief. When given over time, physical     dependence can occur. This results in unpleasant side effects--such as agitation and     nausea--if opioid medications are suddenly stopped. We are interested in knowing if a     medication named Ondansetron can help ease or prevent symptoms associated with opioid     withdrawal. We are also interested in knowing if a similar (but more potent FDA-approved     drug, palonosetron) can more effectively treat withdrawal symptoms with or without     combination with an antihistamine called hydroxyzine (vistaril).   "
214814|NCT00661687|"     The objective of this study is to evaluate the performance of the PureVision Lens designs     when worn on a 30-day continuous wear basis   "
214815|NCT00661700|"     To find out more information on how treating impotence with vardenafil in comparison to     placebo affects the quality of life (QoL) of men and their partners. Subjects will receive     10mg vardenafil or placebo for 4 weeks followed by an 8 week period when the dose of     vardenafil may be reduced to 5mg or increased to 20mg. Subjects will then receive their     'preferred' dose for 14 weeks. During this time Quality of Life Measures will be collected     via questionnaires   "
214816|NCT00661713|"     The proposed study is aimed to assess the antibody response and short-term persistence of     Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal     vaccination schedule in an adolescent population.   "
214817|NCT00661726|"     Thalassemia intermedia (TI) is an inherited blood disorder that can cause anemia due to low     levels of hemoglobin. Decitabine is a medication that may be effective at increasing     hemoglobin levels. This study will evaluate the safety and effectiveness of decitabine at     increasing hemoglobin levels in people with TI.   "
214818|NCT00661739|"     The aim of the study is to establish a feasible combination of bendamustine and paclitaxel in     a weekly schedule. The two agents have different toxicity profiles and are well tolerated     when given in a weekly fashion. The combination might be of special interest for elderly     patients with hormone insensitive breast cancer   "
214819|NCT00661752|"     A new, innovative software image processing method, wide beam reconstruction (WBR), utilizes     resolution recovery and incorporates Poisson noise-reduction into the reconstruction process     of NM images. This method facilitates the reconstruction of low count density myocardial     perfusion SPECT images. Preliminary research indicates that SPECT acquisition time     consequently can be reduced by 60% (less than 5 minutes) for rest and by 75% (just over 3     minutes) for stress, while tomographic image quality is maintained, or even improved. Such a     decrease in image acquisition time decreases patient discomfort during the tomographic     acquisition, decreases the opportunity for patient motion, and improves laboratory     efficiency.   "
214820|NCT00661765|"     1. To evaluate the absorption and elimination of varenicline Formulation A transdermal          delivery system [TDS (patch)] compared to varenicline immediate release tablet          (CHANTIX®).        2. To evaluate the adhesion of the varenicline Formulation A patch.        3. To evaluate the safety and tolerability of a single application of the varenicline patch          and a single oral dose of the varenicline immediate release tablet (CHANTIX®).   "
214821|NCT00661778|"     This study assessed the efficacy and safety of Avastin in combination with docetaxel and     cisplatin as first-line treatment of patients with metastatic or locally advanced non-small     cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m^2,     and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.   "
214822|NCT00661791|"     The purpose of this study was to determine whether massage with or without physical exercise     impacted weight gain or length of hospital stay for premature infants.   "
214823|NCT00661804|"     Thalassemias are inherited blood disorders that can cause anemia and other health problems.     The goal of this study is to collect information on complications of the disease among people     who currently have or previously had thalassemia.   "
214824|NCT00661817|"     Obesity is a serious health problem that is a contributing factor for heart disease and high     blood pressure. This study will evaluate a lifestyle modification program that aims to     encourage weight loss and improve the health of people with high blood pressure from low     income and minority communities.   "
215199|NCT00660673|"     The primary objective is to provide continued access to subjects who would like to continue     levodopa-carbidopa intestinal gel (LCIG), after completion of an open-label study (S187.3.003     or S187.3.004).   "
214825|NCT00661830|"     This trial will be conducted to evaluate the efficacy, safety and tolerability of a     combination of gemcitabine plus sorafenib in comparison of gemcitabine plus placebo as a     first-line palliative therapy in chemo-naive advanced or metastatic CCC. There is strong     scientific rationale for exploring the role of sorafenib in combination with gemcitabine in     advanced CCC.      Sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and     angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the     receptor tyrosine kinases VEGF-R2, R3 and PDGFR-β.      Mutations in these signaling pathways display by far the most common genetic alterations in     CCC and overexpression correlates to poor prognosis. Furthermore, there is no evidence of a     consistent or meaningful pharmacokinetic interaction between sorafenib and gemcitabine,     suggesting that sorafenib can safely be combined with gemcitabine.      Clinical results of a combination of sorafenib and gemcitabine in a phase I study in     pancreatic cancer suggested a therapeutic effect, and the safety and efficacy results     together with the knowledge of the molecular pathology of CCC provide a rationale for a     randomized, placebo-controlled phase II trial consisting of gemcitabine plus sorafenib in     advanced CCC.   "
214826|NCT00661843|"     Insomnia is common in the elderly population and is associated with increased health     problems, reduced quality of life and greater use of sleep inducing drugs. This research aims     to examine the effectiveness of Yoga practice to treat insomnia in elderly people, determine     the ability to enhance their quality of life and determine if it is suitable to western     culture and conditions.   "
214827|NCT00661856|"     The aim of the present study was to investigate the effects of soy and soy plus isoflavones     on bone mineral Density and physical performance in post menopausal women.   "
214828|NCT00661869|"     Obesity is increasing at an alarming rate in patients with schizophrenia, possibly in     association with the increased use of atypical antipsychotics. In order to address the weight     and metabolic syndrome issues, Manhattan Psychiatric Center (MPC) has implemented the     Solutions for Wellness and Team Solutions Program. This program is designed to create a     supportive, educational and monitoring environment to stabilize both the psychiatric and     medical conditions and to prepare patients for independent management of their psychiatric     and physical health condition in the community.   "
214829|NCT00661882|"     RATIONALE: Gathering information about patients with cancer may help doctors learn more about     the disease and plan early diagnosis and treatment.      PURPOSE: This clinical trial is studying computer tools for improving early diagnosis and     treatment in patients with pancreatic cancer, are at risk for pancreatic cancer, or have a     non-cancerous pancreatic disorder.   "
214830|NCT00661895|"     Clinical trials have yet to test the adequacy of HTN control in African Americans (AA) when     both control and intervention groups are given free antihypertensive medications and are     involved in usual versus intensive intervention strategies. Because of this, it has not yet     been determined whether the method of prescribing antihypertensive medications according to     JNC 7 guidelines is more, less, or equally as effective as prescribing antihypertensive     medications and providing intensive behavioral and clinical interventions. Knowledge in this     area of HTN treatment should better able medical and health practitioners to help their AA     subjects control HTN. The BEAT Hypertension Clinic will evaluate this method of HTN control     by proposing a program that will evaluate the difference in HTN control among subjects     receiving usual care and free medications and subjects also receiving free medications, but     additionally being treated in a clinic that operates in a more intensive manner in     relationship to patient behavior modification, patient-clinician interactions, and physical     and social environments. At the conclusion of the study, the BEAT Hypertension Clinic     investigators will report findings and help to answer the question of whether medication     alone or medication combined with intensive behavioral and clinical treatment is more     effective in HTN control in the AA population.   "
214831|NCT00661908|"     Diabetic subjects often report of problems at the workplace or when contracting insurances     because of their diabetes.      By distributing a self-report questionnaire to insulin-treated Type 1 and Type 2 diabetic     subjects we wanted to analyse the frequency of work- and insurance-related discrimination.     Furthermore we wanted to detect socio-demographic and diabetes-related factors which are     associated with increased discrimination at workplace and by insurances. We hypothesized that     diabetes-related discrimination at workplace and by insurances exists and that certain     factors like having severe hypoglycaemic events, being type 1 diabetic or being overweight     would be associated with more problems at work or with insurances.   "
214832|NCT00661921|"     The purpose of this study is to investigate the effects of blocking IL-1 signaling with AMG     108 in type 2 diabetes mellitus patients on glycemic control, as measured by change in HbA1c     from baseline to end of treatment (EOT).   "
214833|NCT00661934|"     The study goal is to investigate the effect of dialysis/medicinal treatment on cardiac     function and heart sounds by recording heart signals from the chest wall.   "
214834|NCT00661947|"     The purpose of this study is to determine whether sucrose vs high fructose corn syrup from a     soft drink results in differences in various metabolic byproducts such as fructose, glucose,     serum uric acid, triglyceride and lactate.   "
214835|NCT00661960|"     This research is being done to study how the immune system in the small intestine improves     after taking antiretroviral (anti-HIV) medications. The main purpose is to measure the     increase in the numbers of immune cells in the intestine to see if one type of HIV medication     gives different results than other types of HIV medications.   "
214836|NCT00661973|"     The main objective is to evaluate how treatment with inhaled corticosteroids (ICS) affects     the characteristics of airway smooth muscle (ASM) cells from asthmatic subjects. Our     hypothesis is that airway smooth muscle cell dysfunction plays an important role in the     pathogenesis of asthma, and that treatment with inhaled corticosteroids reverses the     abnormalities in airway smooth muscle cell function.   "
214837|NCT00661986|"     Low habitual intake of low-dose dark chocolate (6 g/day) has been shown to have a beneficial     effect on arterial blood pressure in one previous study. The trial will assess if ingestion     of a higher but still moderate dose (25 g/day) over 3 months will have a more pronounced     effect. The population will consist of cardiovascular high-risk patients only (who will     potentially benefit most from blood-pressure lowering).   "
248570|NCT01109030|"     The purpose of this study is to determine whether Pioglitazone as an adjunct to Citalopram is     effective in treatment of moderate to severe depression   "
214838|NCT00661999|"     RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells     contain iron that is needed to carry oxygen to the tissues. It is not yet known whether     giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective     than giving darbepoetin alfa together with a placebo in treating anemia caused by     chemotherapy.      PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with     iron to see how well it works compared with giving darbepoetin alfa together with a placebo     in treating anemia caused by chemotherapy in patients with cancer.   "
214892|NCT00662701|"     The purpose of this study is to compare 2 invasive strategies for Atrial Fibrillation     treatment, Endocardial catheter ablation isolation of the Pulmonary veins versus minimally     invasive thoracoscopic surgical epicardial isolation. Both strategies are in use for several     years now, and have been reported as a successful strategy with success rates of 60-90%.     However, it is not known which technique is preferable in a given patient population in terms     of efficacy to cure AF, safety, or patient discomfort. Therefore, in the present trial a     randomized study is proposed to provide more insight into the relative merits of both     techniques   "
214839|NCT00662012|"     Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the     world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a     threat for military soldiers in areas where this disease is found. Sodium stibogluconate     (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND)     product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and     viseral leishmanias. This drug is not licensed for commercial use in the United States     because of very limited need for the product in the U.S.A. The objective of this protocol is     to provide sodium stibogluconate for the treatment of cutaneous leishmaniasis and mucosal     leishmaniasis (pentavalent antimonials curently considered the drug of choice for these     infections) Provide sodium stibogluconate as a second line treatment for viscerotropic and     visceral leishmaniasis (liposomal amphotericin is the drug of choice for these types as it is     FDA approved for vusceral leishmaniasis).   "
214840|NCT00662025|"     To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese     patients with advanced/metastatic breast cancer.   "
214841|NCT00662038|"     This is an open-label, multi-center, extension study for patients with IPF who complete a     qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain     additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a     qualifying InterMune clinical trial of pirfenidone.   "
214842|NCT00662051|"     Asthma is a chronic inflammatory disorder of the airways affecting approximately 15 million     individuals in the U.S. The rate of asthma exacerbations among women is twice that of men     after adolescence, and a large proportion of females with asthma report worsened asthma     symptoms during different phases of the menstrual cycle. Hormonal influences have been     hypothesized to account for these differences. Decreased peak flow rates and increased     symptoms have been found in females during the premenstrual phase of the menstrual cycle when     estrogen and progesterone levels are low. Estrogen and progesterone have both been found to     reduce smooth muscle contractility and increase bronchial smooth muscle relaxation. A     perimenstrual shift toward a Th2 (allergic) phenotype characterized by a decreased     interferon-gamma to interleukin-10 ratio has been demonstrated in healthy women not using     oral contraceptives compared to midcycle; however, the effect was blunted in healthy oral     contraceptive pill users, implying hormonal modulation of the allergic phenotype. Several     case reports have demonstrated a therapeutic benefit of oral contraceptives in decreasing     asthma exacerbations and corticosteroid requirements. Human studies have demonstrated that     estrogen decreases pro-inflammatory cytokine generation, neutrophil recruitment, and inhibits     inducible nitric oxide synthase activity, which could lead to lower exhaled nitric oxide     levels.      The measurement of the fractional concentration of exhaled nitric oxide (FENO) is a     non-invasive method to assess airway inflammation in adults and children with asthma. The     hypotheses of the current study are that women using oral contraceptives will have lower FENO     levels and better asthma control as assessed by the Asthma Control TestTM during different     phases of the menstrual cycle. This study may identify clinically important changes in FENO     levels and asthma control during the menstrual cycle and modification of these effects by     oral contraceptive pills. This data may lead to future studies aimed at identifying     therapeutic roles for hormones in asthma therapy in women.   "
214843|NCT00662064|"     The function of the lower urinary tract is simple - urine storage and voiding. However,     despite this simplicity of function, the control of the lower urinary tract is a rather     complex, multilevel process (urothelium, detrusor, peripheral nerves, spinal cord and higher     cerebral centres) and the mechanisms involved remain poorly elucidated.      This study is designed to gain a more in depth understanding of the lower urinary tract     function. Using bladder biopsies, tissue staining for characteristic markers present on     nerves and other cells will be performed. We hypothesize that certain markers are altered in     disease and turn back towards the control level of healthy people or patients with successful     medical treatment.   "
214844|NCT00662077|"     This project wills to determine the incidence of osteoporosis in our population of     HIV-infected patients and to assess the efficacy and security of ibandronate, whose efficacy     in post-menopausal women has already been proved.   "
214845|NCT00662090|"     The aim of the study is to improve the accuracy of diagnosis for children and adolescents     with MDS by a standardized review of morphology and standardized cytogenetic and molecular     analysis.      The primary objectives of the study are:        -  To evaluate the frequency of the different subtypes of MDS in childhood and adolescence          by a standardized diagnostic approach        -  To evaluate the frequency of cytogenetic and molecular abnormalities:      Specifically using array-CGH to evaluate the frequency of subtle chromosomal imbalances, i.e.     gains and losses of defined chromosomal regions, and amplifications.      Specifically using mFISH to identify unknown chromosomal aberrations, particularly subtle     translocations involving new candidate genes, and to better define chromosomal breakpoints.      The secondary objectives of the study are:        -  To assess survival for children and adolescents with MDS and JMML        -  To evaluate relapse rate, morbidity and mortality in children with MDS and JMML treated          by HSCT   "
214846|NCT00662103|"     RATIONALE: Aerobic exercise, resistance exercise, and flexibility and relaxation training may     reduce fatigue and improve the health and quality of life of breast cancer survivors. It is     not yet known which type of exercise is more effective for inactive older female breast     cancer survivors.      PURPOSE: This randomized clinical trial is studying aerobic exercise to see how well it works     compared with resistance exercise or flexibility and relaxation training in improving the     health and quality of life of inactive older female breast cancer survivors.   "
214847|NCT00662116|"     This study is being done to evaluate the safety and effectiveness of alagebrium in subjects     diagnosed with diastolic heart failure. The primary assessment for effectiveness is the     assessment of exercise tolerance.   "
214848|NCT00662129|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel albumin-stabilized     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Giving combination chemotherapy together with bevacizumab may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized     nanoparticle formulation and gemcitabine together with bevacizumab works in treating patients     with metastatic breast cancer.   "
214893|NCT00662714|"     Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections     with respect to blood glucose control, weight and pulmonary function over 2 years in patients     with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the     phase III trial.   "
214894|NCT00662727|"     Low intensity shockwaves have been proven in animal studies to induce local growth of new     blood vessels from existing ones.      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients     with refractory angina not amenable to revascularization with angioplasty or bypass surgery.   "
214850|NCT00662155|"     The lack of scientific attention devoted to the placebo effect as a phenomenon in its own     right probably reflects the paucity of theoretical positions within which to organize the     existing data and design new research. The proposed investigation 1) is an attempt to advance     from a descriptive to an experimental analysis of the placebo effect, taking into account     classical conditioning effects, and 2) examines the clinical implications of partial     reinforcement as it is applied to the treatment of insomnia. Subjects with primary insomnia     will be treated with zolpidem for a period of one month and then randomized to one of four     groups for a period of 12 weeks: one receiving full dose zolpidem on a nightly basis     (continuous reinforcement), one receiving full dose zolpidem on 14 of 28 nights where placebo     is provided on non-drug nights (partial reinforcement), one receiving full dose zolpidem on     14 of 28 nights where no pills are imbibed on non-drug nights (intermittent dosing), and one     receiving 5 mg dose zolpidem on a nightly basis (continuous reinforcement with half the     standard dose). Following treatment, subjects will be entered into an extinction protocol     during which they will 1) continue on the schedule assigned during the experimental period,     2) receive only placebo, or 3) receive neither drug nor placebo. Sleep and daily functioning     will be monitored on a daily basis via sleep diaries for the duration of the study. It is     hypothesized that, holding cumulative dose constant, a partial schedule of reinforcement will     enable patients to better maintain their clinical gains as compared to subjects that receive     either continuous reinforcement with half the standard dose or half the frequency of use.      Relevance: The proposed research is not an attempt to offer a behavioral alternative to drug     treatment; it is an attempt to acknowledge and capitalize on a behavioral dimension in the     design of drug treatment protocols. The value of the proposed research resides in its     capacity to provide for the long term treatment of insomnia in a manner that increases the     durability of pharmacotherapy while reducing the overall amount of medication required. If     proven effective in the current application, this new approach to pharmacotherapy and placebo     effects is likely to stimulate new interdisciplinary research for the treatment of a variety     of chronic diseases.   "
214851|NCT00662168|"     This proposed pilot study is to conduct detailed interviews into the medical, environmental,     and family histories The second phase of this study project is to and to collect blood     specimen to obtain DNA. The Blood specimen and DNA will be processed by the Rutgers     University Cell and DNA Repository (RUCDR) and stored for a second phase of this pilot. The     purpose is to rule out Familial Multiple Endocrine Neoplasia (MEN 1), and succinate     dehydrogenase complex, subunit D (SDHD), gene inactivation thought to be associated with     different types of carcinoid cancer.   "
214852|NCT00662181|"     A follow-up study on the randomized, controlled, double-blind HIGH: low study. We will     examine the participants from the HIGH: low study min. 6 months after finishing the HIGH: low     study. We will look at the parameters: quality of life, sugar-metabolism, fat-metabolism,     fat-redistribution and cytokines. The study will use the participants control visit, and the     only additional examination will be the danish MOS-HIV questionnaire.   "
214853|NCT00662194|"     Data from this study will provide the first information how the innate immune system may be     altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor     changes with HIV co-infection therapy.   "
214854|NCT00662207|"     The purpose of this investigation is to evaluate methods in spinal cord injured individuals     to improve reflex urination. Anal dilation will be investigated to reduce high urethral     resistance and a vibrator on the patient's bottom will be tested to induce more sustained     bladder contractions for better bladder emptying.   "
214855|NCT00662220|"     Optimal ribavirin dosages are essential in achieving SVR (sustained virological response).     Several studies have shown higher SVR rates in patients receiving higher doses of ribavirin.     Therefore we propose a randomized controlled open label multicenter trial to investigate     wether high (25-29mg/kg) dose ribavirin can improve outcome in patients in infected with     hepatitis C virus genotype 1 or 4 compared to standard dose (12-15mg/kg).   "
214856|NCT00662233|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating     patients with sarcoma.   "
214857|NCT00662246|"     The radical treatment for Hepatocellular carcinoma (HCC) is surgery. However, it is only for     10 to 20% of all patients and 10 to 30% of them have relapsed every year after surgery. For     an inoperable case, we can consider Liver transplantation. But there is not enough organ     donor and it is very expensive. In that case, various treatment modalities for HCC (i.e.,     transcatheter arterial embolization [TAE] and percutaneous ethanol injection [PEI],     radiofrequency ablation etc.) have become clinically available. In addition, after these     treatment, radiation therapy can be conducted as a combined treatment. If it is difficult,     radiation therapy can be conducted alone. In this case, radiation therapy can use     fractionated stereotactic radiation therapy [FSRT] or 3D simulation to minimize the exposure     to normal tissues. In recent years, Proton therapy is a new radiation therapy which remaining     energy is released when they reach the tumor, delivering the most effective dose of     radiation. The purpose of this trial is to improve the therapeutic effects by using proton     therapy.   "
214858|NCT00662259|"     The purpose of this study is to find out how an anti-anxiety drug or placebo affects the     activity of your brain when you are at rest and when you are viewing emotional material, such     as, emotional faces and pictures.   "
214859|NCT00662272|"     This study is designed to assess safety, tolerability and immunogenicity of Fluzone® vaccine     with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy     adults 18-49 years of age.   "
214860|NCT00662285|"     Description of the effect of standard iron supplement on iron status in blood donors      Hypothesis:      For each person in each group (group a without iron supplement or group b with iron     supplement) individual biological variation in reticulocytes, tested day 1 and day 8 will be     described. Groups a and b will be compared on iron status from day 1 and day 8.        -  H1 null: There is no significant intraindividual difference in reticstatus at day 1 and          at day 8, in group a.        -  H2 null: There is no significant intraindividual difference in reticstatus at day 1 and          at day 8, in group b        -  H3 null: There is no significant difference in iron status for the two groups, a and b,          at day 1 and at day 8.   "
214861|NCT00662298|"     The purpose of the study is to evaluate whether severe asthmatic subjects have abnormal     prednisolone absorption, and how this might affect the anti-inflammatory effects of     prednisolone.      The aims of the study are        1. to compare the effect of high dose prednisolone on clinical and physiological responses        2. to determine the effect of long-term oral prednisolone therapy on corticosteroid          responsiveness and prednisolone pharmacokinetics        3. to measure the effect of high dose prednisolone for 14 days on p38 MAPK activity, GR          translocation and activation of NF-kB        4. to validate an easier method of measuring corticosteroid insensitivity using whole          blood, and a spot prednisolone serum level as a measure of adherence to prednisolone          therapy   "
214862|NCT00662311|"     This phase I/II trial studies the side effects and best dose of vorinostat when given     together with paclitaxel and radiation therapy and to see how well it works in treating     patients unable to tolerate cisplatin with stage III non-small cell lung cancer (NSCLC) that     cannot be removed by surgery. Vorinostat may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving vorinostat together with paclitaxel and radiation therapy may kill more tumor cells   "
214863|NCT00662324|"     The purpose of this study is to develop a Question Prompt List (QPL) about clinical trials     for cancer patients and find out what cancer patients and their caregivers think of the QPL.     A QPL is a list of questions patients might want to ask their doctors during their     appointments.      We will conduct three focus groups to talk about using QPL's as a new way to recruit patients     like you to clinical trials. The three groups will be made of patients who have and have not     participated in clinical trials, their caregivers and doctors. This study is also being done     to learn about how the QPL affects the question asking behavior of patients during their     appointments with doctors at Memorial SloanKettering Cancer Center (MSKCC).   "
214864|NCT00662337|"     The purpose of this study is to determine if two formulations of diphenhydramine     hydrochloride are bioequivalent.   "
214865|NCT00662350|"     To measure intra-prostatic temperatures and evaluate the shape and size of necrotic lesions     achieved under the standard treatment protocol in men with benign prostatic hyperplasia     (BPH).   "
214866|NCT00662363|"     Patients requiring opioids for post-operative pain control following elective orthopedic     procedures which has resulted in constipation symptoms, and who are in inpatient     rehabilitation will be randomized to two different treatment arms: lubiprostone or senna.     Baseline scores regarding constipation and a quality of life bowel questionnaire will be     compared the day following 6 days of treatment intervention.   "
214867|NCT00662376|"     The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects     of the oral nutritional supplement (PreOP Booster) given to patients prior to     gastrointestinal surgery.   "
214868|NCT00662389|"     The purpose of this feasibility study is to gain an initial assessment of the acute safety     and performance of the Apsara Thermal Wand System in human facial tissue.   "
214869|NCT00662402|"     In this study we wish is to determine whether extensive (up to 15 hours) multidisciplinary     consultation in biostatistics, study design, data management, ethics, and writing provided by     the UCSF Clinical and Translational Science Institute's (CTSI) Consultation Services program,     improves peer review scores of career development grants compared to usual levels of     consultation.      We hypothesize that extensive multidisciplinary consultation will improve peer review scores     of career development grants compared to usual levels of consultation.      We hypothesize that extensive multidisciplinary consultation will lead to greater numbers of     funded grants when compared to the usual levels of consultation.   "
214870|NCT00662415|"     Almost everyone who has a traumatic limb amputated will experience a phantom limb - the vivid     impression that the limb not only still is present, but also in many cases, painful.     Preliminary data from study WRAMC WU# 05-71034, Pilot study to assess the efficacy of     mirror-box and mental visualization treatments on phantom limb pain demonstrates that 4     weeks of mirror therapy is effective for treating phantom limb pain (PLP) and suggests that     vision is a key component modulating PLP and may be the explanation for the efficacy of     mirror therapy, as subjects view the reflected image of their intact limb while attempting to     move the amputated, or phantom, limb. We propose conducting a study using functional magnetic     resonance imaging (fMRI) to identify brain regions critical for the mirror effect and to     study the relationship of visual activation to the sensation of phantom pain. Subjects will     have an fMRI scan prior to starting therapy, 2 weeks after starting mirror therapy and again     after 4 weeks of mirror therapy. Data will be gathered daily on the number of episodes of     phantom limb pain, the average length of episodes, and the average intensity of pain.   "
214871|NCT00662428|"     The cost-effectiveness of a new, guideline oriented sequential inpatient - outpatient     treatment model will be investigated. Secondary outcomes are: patient satisfaction,     practitioners' satisfaction and influence on work.   "
214872|NCT00662441|"     Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection     sufficient for satisfactory sexual performance. An ideal treatment option should be effective     and reliable, have minimal side effects, be simple to use and affordable. The purpose was the     evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile     Dysfunction (ED).   "
214873|NCT00662454|"     The purpose of the blood spot validation portion of the study is to test if measuring female     hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw     from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two     populations of oral contraceptive users: heavier and lighter women.   "
214890|NCT00662675|"     The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT     in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with     clinical symptoms of exocrine pancreatic insufficiency (EPI).   "
214891|NCT00662688|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from     forming in patients being treated with chemotherapy. It is not yet known whether gemcitabine     is more effective when given alone or together with dalteparin and/or capecitabine in     treating patients with pancreatic cancer.      PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots     in patients with pancreatic cancer receiving treatment with different combinations of     gemcitabine and capecitabine.   "
214956|NCT00657488|"     The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial     treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with     thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs)     in the treatment of refractory or relapsed multiple myeloma after at least two courses of     treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the     safety of the treatment.   "
214874|NCT00662467|"     Following severe heart attacks involving the front wall of the heart (anterior myocardial     infarction), patients are at risk of developing blood clots in the main pumping chamber that     can cause a stroke. In the past, studies have shown that a blood thinner (warfarin) can     decrease the risk of stroke and clot formation if administered to patients after an anterior     myocardial infarction.      However, in today's current practice, certain heart attack patients are commonly treated with     two blood-thinning medications (aspirin and clopidogrel) to prevent recurrent heart attacks.      Thus, a clinical problem is created as physicians are not clear how to treat patients after     an anterior myocardial infarction who are at risk of a clot but require aspirin and     clopidogrel to keep their blood vessels open. Adding warfarin to the combination of aspirin     and clopidogrel will possibly decrease the risk of stroke but increase the risk of bleeding.     Currently, there is no good evidence to help guide physicians. As demonstrated by a survey     done at the Hamilton Health Sciences, there is a fifty/fifty split between physicians who use     dual (aspirin and clopidogrel) versus triple (aspirin, clopidogrel, and warfarin) therapy in     the treatment of similar patients as described above.      The purpose of this study is to address the bleeding and stroke complications in patients     after a severe anterior myocardial infarction. Half of the eligible patients will receive     dual therapy and half will receive triple therapy. We will compare the incidence of stroke,     blood clots, and bleeding complications between the two groups at 3 months.   "
214875|NCT00662480|"     Well-documented health benefits may be achieved through prophylactic screening for     cardiovascular disease. The advantages are fewer premature deaths and a reduction in the     number of hospital admissions and amputations. Furthermore, hospitals will benefit from the     derived reduction in the pressure on surgery and intensive care capacities at vascular     surgery departments.      It therefore seems extremely relevant to offer joint screening for abdominal aortic aneurysm,     peripheral arterial disease and hypertension, even if the benefit and costs of such a measure     are not currently known.      Consequently, the primary objective of the study is to establish the effect and     cost-efficiency of a joint circulation screening programme for 40,000 men aged 65-74 years in     a randomised, clinically controlled study.      The project manager will train six nurses to measure ABI and perform ultrasound scans of the     aorta. The nurses form three teams which will each be equipped with a portable Doppler, blood     pressure cuff and portable ultrasound scanner. Each team will operate from the hospitals in     the Region. Civil registration number (in Danish: CPR), name and address information will be     supplied by the Clinical Epidemiological Department (CED), which will also perform the     randomisation in groups of approx. 1,000 to avoid too long a period from data extraction to     invitation. Half of the randomised subjects will be invited to participate in a circulation     examination focused on PAD, AAA and hypertension, while the other half will be controls Men     with positive findings are informed and proper preventive actions is taken. Annual controls     are offered, and AAA exceeding 5.5 cm in diameter is offered operation.      The primary efficiency variables are death, cardiovascular death and AAA-death. The secondary     efficiency variables are hospital services related to cardiovascular conditions and costs for     such services in accordance with current DRG rates.      The entire population, the controls as well as the screening group, will be monitored for a     period of 10 years. Information concerning deaths, including date of death, is obtained from     the Civil Registration System, information on visits to outpatient clinics and hospital     admissions caused by cardiovascular conditions including amputations is obtained from the     National Patient Registry. From the Danish Causes of Death Registry information on cause of     death is collected. The information is classified with regards to cause; AAA or     cardiovascular. The cardiovascular interventions are identified in the vascular surgery     database (Karbasen). Major follow-up is performed at 3, 5 and 10 years.      A steering and data validation group will be formed including the project manager and a     representative from the Clinical Epidemiology Department. Furthermore, a vascular surgeon     from each of the two affected departments in the region will participate.      Total mortality, cardiovascular and AAA-related mortality and initial cardiovascular hospital     service are compared for the two groups using Cox proportional hazards-regression analysis     which facilitates description of the risk ratio. The cost-efficiency calculation will be     adjusted for quality of life.   "
214876|NCT00662493|"     Pain at the front of the knee is a common condition treated by physical therapists. Treatment     may consist of generalised strengthening exercises directed at the quadriceps muscle or     specific retraining aimed at restoring motor control at the knee. This study compared these     two exercise programs in a group of people who were painfree at the time to evaluate their     effect on motor control. It was hypothesised that only the motor retraining program would     influence motor control at the knee.   "
214877|NCT00662506|"     This phase I/II trial is studying the side effects and best dose of cediranib to see how well     it works when given together with temozolomide and radiation therapy in treating patients     with newly diagnosed glioblastoma. Cediranib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs     used in chemotherapy, such as temozolomide, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy     uses high-energy x-rays to kill tumor cells. Giving cediranib together with temozolomide and     radiation therapy may kill more tumor cells.   "
214878|NCT00662519|"     The primary purpose of this study is to find out if giving a 12 week course of Neulasta     (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D)     is safe. The secondary purpose of this research study is to determin if giving GCSF to     patients with T1D changes the immune system or preserves insulin production.   "
214879|NCT00662532|"     This study is for people at least 21 years old who have signs of problems, like swollen gums     and shrinking bones, by dental implants.   "
214880|NCT00662545|"     This study will evaluate HIV-HBV infected individuals who have evidence of HBV replication in     the blood after taking 48 weeks of more of the HBV active medication tenofovir in combination     with emtricitabine or lamivudine. Eligible participants will be randomized to receive 24     weeks of entecavir (ETV) 1 mg versus continued standard of care antiretroviral therapy. After     24 weeks, individuals on entecavir or who remain HBV viremic on standard of care will receive     ETV o for an additional 24 weeks. The hypothesis is that intensification with entecavir will     reduce HBV DNA at 24 weeks more than continued antiretroviral therapy without entecavir.   "
214881|NCT00662558|"     To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low     Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6   "
214882|NCT00662571|"     In 2004, acamprosate was approved in the U.S. for abstinence maintenance, by decreasing     craving, in alcoholic patients who have undergone detoxification. while a new anti-craving     drug was encouraging, only 36.1% of the subjects treated with acamprosate remained abstinent     for 6 months. Having the ability to identify treatment responsive individuals would have a     major impact on the use of acamprosate.   "
214883|NCT00662584|"     Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method that holds     promise for treating several psychiatric disorders. Yet the most effective location and     parameters for treatment need more exploration. Also, whether rTMS is an effective treatment     for individuals with a DSM-IV diagnosis of Generalized Anxiety Disorder (GAD) has not been     empirically tested. The goal of this pilot study is to evaluate whether fMRI guided rTMS is     effective in reducing symptoms of GAD.   "
214884|NCT00662597|"     The purpose of this study is to determine if adding ASA404 to standard chemotherapy makes the     cancer treatment more effective in patients with advanced lung cancer.   "
214885|NCT00662610|"     To assess the effect of naproxcinod vs. naproxen on arterial blood pressure patients with     osteoarthritis and controlled essential hypertension   "
214886|NCT00662623|"     The purpose of this study is to examine the effect of different methods of providing     education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and     how that education might help to improve health outcomes and the amount of time CPAP is used.   "
214887|NCT00662636|"     RATIONALE: Dasatinib and lapatinib ditoslylate may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib and     lapatinib ditoslylate when given together in treating patients with advanced solid tumors     that cannot be removed by surgery.   "
214888|NCT00662649|"     This extension study of was designed to evaluate the long-term safety, tolerability, and     efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was     an extension to the 24-month Core study (CFTY720D2301/NCT00289978).   "
214889|NCT00662662|"     The goal of this behavioral research study is to learn if certain sexual behaviors increase     the risk for developing head and neck cancers associated with a virus called human     papillomavirus (HPV-16). Knowing this information could help doctors better teach patients     about avoiding certain risk factors, which may help to prevent the disease.   "
214957|NCT00657501|"     This study is a randomized, double-blind, placebo-controlled, multi-center study of the     safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal     women.   "
214898|NCT00662779|"     It is our primary hypothesis that pretreatment with arformoterol will provide superior     protection against EIB in children with mild-moderate asthma compared to placebo added to the     current asthma regimen.      Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB     compared to inhaled formoterol by dry powder inhaler.   "
214899|NCT00662792|"     The primary objective of this trial is to establish superiority of the once-daily Tiotropium     plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in     night-time lung function response over the comparator treatments inhaled in their established     dose regimens when administered for 6-week periods to patients with chronic obstructive     pulmonary disease (COPD). The main secondary objective is to evaluate the safety of the     Tiotropium plus Salmeterol Inhalation Powder versus the comparator treatments.   "
214900|NCT00662805|"     Primary objective: Evaluation of the safety of Seretide discus administration in subjects     with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1),     treatment phase (visits 2-5. In the case of AE, there will be another visit (visit 6) as a     follow up visit - follow up phase.   "
214901|NCT00662818|"     The purpose of this study is to evaluate the safety and efficacy of telcagepant in the     treatment of acute migraine in participants with stable vascular disease.     Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The     primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.   "
214902|NCT00662831|"     The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot     ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area     including intact skin healing.   "
214903|NCT00662844|"     That on average it will require a vitamin D dose of 1700IU/day to increase the serum     25hydroxyvitamin D level from 20 to 30ng/ml in young Caucasian women and a dose of 1860 to     2480 IU/day in African American   "
214904|NCT00662857|"     28 subjects to be enrolled for a screening period, 3 dosing visits & a follow-up visit.     Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one     30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin     analogue).   "
214905|NCT00662870|"     This study was designed to assess the lot comparability of DAPTACEL, as well as the safety     and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.      Stage I Primary Objectives:        1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered          with other recommended vaccines.        2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of          DAPTACEL when co-administered with other recommended vaccines.        3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB          concurrently administered in a different injection site with DAPTACEL when these          vaccines are co-administered with other recommended vaccines.      Stage II Primary Objectives:        1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib          or other infant vaccines.        2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when          co-administered with ActHIB in toddlers.   "
214906|NCT00662883|"     To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal     absorption of PMI-150 (intranasal ketamine HCl)   "
214907|NCT00662896|"     To assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in     patients with osteoarthritis and controlled essential hypertension   "
214908|NCT00662909|"     The study is intended to test the efficacy, safety and tolerability of two doses of     mirabegron against placebo to treat patients with symptoms of overactive bladder   "
214909|NCT00662922|"     Hypoglycemia occurs frequently during intensive blood glucose control in critically ill     patients. The incidence of hypoglycaemia is associated with impaired outcome. However, it is     hitherto unknown if hypoglycaemia itself predisposes patients to neurological impairment,     e.g. cognitive dysfunction, or if it is the underlying medical condition that makes the     patient prone to a high risk of hypoglycaemia and, concomitantly, neurocognitive impairment.     Therefore we investigate neurocognitive function in patients who had hypoglycemias during     their intensive care stay and compare the results to patients without hypoglycaemia whose     medical conditions are matched to the hypoglycaemia patients.   "
214953|NCT00657449|"     The study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the     signs and symptoms of acute first- or second-degree ankle sprain. The study also evaluated     the disability status, tolerability and safety of these treatments.   "
214910|NCT00662935|"     The aim of this study is to evaluate the efficacy and safety of deep brain stimulation (DBS)     in chronic and treatment-resistant CH. Inclusion criteria are: patients with chronic CH     (>3years), with daily attack and non response to adequate treatment. Electrodes are implanted     stereotactically in the postero-inferior hypothalamus. In this crossover, randomized,     placebo-controlled double-blinded study, the efficacy of DBS is evaluated using comparison of     two one-month sequences: one with stimulation on and the other with stimulation off     (placebo sequence). Efficacy is defined as ≥50% decrease of weekly frequency of CH attacks.     After the randomized period, long-term efficacy and safety are evaluated after one year of     stimulation in open conditions.   "
214911|NCT00662948|"     After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin,     vincristine and prednisone) the patients are randomized to:      A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg      B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months   "
214912|NCT00662961|"     To compare periosteum versus bone fixation in forehead lift.   "
214913|NCT00662974|"     In this study we intend to randomly assign each parturient one of two commonly used oils to     be applied during the second stage of labor, one of them containing vitamin E. We will verify     if perineal massage increases the chances of delivering with an intact perineum comparing the     two oils. As secondary objectives, we will evaluate the effects of perineal massage on     specific tear location, the severity of perineal tears and the amount of suture material     required for repair.   "
214914|NCT00662987|"     To determine whether a 3-day course of postoperative antibiotics is effective as a 7-day     course in reducing pain and reducing time to resumption of normal diet and activity following     pediatric tonsillectomy   "
214915|NCT00663000|"     Observational, Cross-sectional, longitudinal, multi-center, diagnostic study      Cross-sectional part of the study: To evaluate the influence of acromegaly on glucose     tolerance      Longitudinal part of the study: To evaluate the changes of impaired glucose tolerance during     standard treatment of acromegaly. Adult patients with established acromegaly      Cross-sectional part of the study: 150 patients      Longitudinal part of the study: 58 patients   "
214916|NCT00663013|"     The investigators propose to study the effects of virtual reality (VR) on patients' pain     perception during burn wound care. Such variables include psychiatric diagnosis and standard     pain coping (i.e. pain catastophizer vs. non-pain catastrophizer).Aims: The investigators     intend to evaluate the use of virtual reality in pain distraction for burn patients     undergoing burn wound care. To that end our aims are: 1) To determine if pain perception will     be less during the portion of the procedure in which the patient is immersed in the VR     session in comparison to the portion of wound care which will occur without VR immersion. 2)     To determine if anticipatory anxiety will be less for the portion of wound care that includes     the virtual reality in comparison to the portion without virtual reality. 3) To determine if     current psychiatric diagnosis, especially acute stress disorder and depression, is related to     higher pain perception and greater decrease in pain with the virtual reality distraction. 4)     To determine if being a pain catastrophizer is related to higher pain perception and     greater benefits from the   "
214917|NCT00663026|"     The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of     mild to moderate Alzheimer disease. Subjects will be in the study for six months and will     receive subcutaneous injections once per week.   "
214918|NCT00663039|"     Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom     domains and functional impairments. Existing treatments of schizophrenia, although effective     against positive symptoms, fail to benefit negative symptoms, the focus of the current     protocol. One of the strategies of novel drug development depends on identifying heritable     physiological deficits that mark the disease liability and are thought to occur along the     causal pathway of negative symptoms. These heritable physiological deficits are often found     in the biological relatives of schizophrenia proband; particularly those who have     schizophrenia related personality styles [defined by schizophrenia spectrum personalities     (SSP) in the diagnostic system], even though they do not have the full-blown illness. The     current protocol will pilot a strategy of targeting biomarkers of negative symptoms using     intranasal oxytocin in relatives of schizophrenia patients. The drug probe studies in such     non-clinical sample have several advantages including the absence of other drug treatment     that may modulate the response, and the lack of generalized deficits causing problems with     task comprehension/engagement that may mute the therapeutic signal. In addition, finding of     efficacy of the experimental drug on the target physiological deficit and the associated     symptoms has clinical implications on its own rights. This is because about 25% of subjects     with schizophrenia spectrum personality disorders experience serious functional impairments.      Oxytocin is an extensively used drug, which is well tolerated with few serious side effects.     Several lines of evidence suggest its putative role in the treatment of negatives symptoms,     particularly a lack of social drive and related symptoms.   "
214919|NCT00663052|"     The purpose of this study is to compare the safety and efficacy of different doses of     etanercept for the treatment of moderate to severe psoriasis.   "
214920|NCT00663065|"     This is study to determine the safety of PAZ-417 in healthy adults over 65.   "
214921|NCT00663078|"     The purpose of this study is to develop a structured CBT group intervention for women with     depression of mild or moderate severity and to pilot a randomized controlled trial to compare     this intervention with usual care in socially deprived areas in Bristol, incorporating     qualitative methods to assess acceptability.   "
214922|NCT00663091|"     To test safety and efficacy of Bacteriophage on Venous Leg Ulcers.   "
214923|NCT00663104|"     The aim of the study is to compare the effect of a progressive, periodized exercise training     designed to impact bone, CHD-risk-factors and menopausal complaints versus the combined     effect of exercise and phytoestrogen (cimicifuga racemosa; CR). After randomization, 84     females 1-3 year postmenopausal with no medication or illness affecting bone metabolism     exercise over 12 months (EG; 42 with, 42 without CR), 42 women serve as wellness-control.     Three group training sessions/week will be performed in the EG. Both groups will be     individually supplemented with calcium and Vit-D (cholecalciferol).   "
214954|NCT00657462|"     This project will study whether reminder prompts increase PAML Builder application feature     utilization.   "
214924|NCT00663117|"     It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the     bowel and quality of life in subjects with active Crohn's disease compared to placebo. In     order to test this hypothesis the following specific aims are proposed:        1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of          Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain          assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and          quality of life surveys;        2. Examine the effects of naltrexone given over 3 months compared to 6 months for          durability of response;        3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's          disease, and        4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin          levels of subjects on therapy.      Purpose statement: The purpose of this study is to evaluate the effects of low dose     naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this     compound in those with active Crohn's disease.   "
214925|NCT00663130|"     Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes     post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe     ED   "
214926|NCT00663143|"     Thiazolidinediones (TZDs) are a commonly used antidiabetic drugs currently used by over a     million patients in the United States. Recent studies have shown that treatment with TZD may     increase the risk of bone fractures. The cause of bone loss is not known. We believe that TZD     may cause increased accumulation of fat in the bone marrow, which may cause decrease bone     formation and weak bones. .   "
214963|NCT00657579|"     To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering     intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular     Hypertension   "
214927|NCT00663156|"     This research study is to evaluate the natural history of fat transplanted from a person's     body to their breasts. We are seeking a natural, safe, and effective alternative to breast     implants. Patients will undergo liposuction of their body followed by infiltration of this     harvested fat around their breasts. The study protocol will involve preoperative and     postoperative photographs, mammograms, and MRI to look for changes in the breast shape and     size, as well as any internal changes in the breast tissue.   "
214928|NCT00663169|"     This is an exploratory proof-of-concept study to evaluate the safety and efficacy of     canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.   "
214929|NCT00663182|"     The aim of this study is to evaluate the effect of Entecavir for patients With decompensated     HBV-Related cirrhosis.   "
214930|NCT00663195|"     The purpose of this study is to evaluate the effects of spironolactone on circulating MMP     levels and insulin resistance in patients with chronic heart failure.   "
214931|NCT00663208|"     The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during     dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C     infection   "
214932|NCT00663221|"     We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone     reshaping in menopausal women.   "
214933|NCT00663234|"     Treatment of HIV with combination antiretroviral regimens frequently results in the     suppression of HIV viral load, significant immune recovery, and delayed disease progression.     However, treatment with these regimens, particularly protease inhibitors (PIs), has been     associated with significant increases in cholesterol and triglycerides in HIV-infected adults     and children. The purpose of this study was to evaluate the safety and effectiveness of     escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and     triglyceride levels, in HIV-infected children receiving stable antiretroviral regimens.   "
214934|NCT00663247|"     Diverticulosis (bulges in the bowel wall) affects two third of the elderly population in the     UK. Diverticular disease and its complications are responsible for 68000 hospital admissions     and 2000 deaths per year. It commonly produces recurrent short lived abdominal pain, changes     in bowel habit and incontinence. The causes of symptoms are not known and the treatments     unsatisfactory. Recent studies have found an association between inflammation, alteration of     bowel nerves and symptoms. Mesalazine is an anti-inflammatory drug used in inflammatory bowel     conditions, such as ulcerative colitis and crohn's disease. We plan to perform a randomized     double blind (neither the patients or the doctors known which treatment the patient is     taking) placebo (sham medication) controlled trial of mesalazine in symptomatic diverticular     disease patients. We anticipate a reduction in the amount of inflammation, bowel nerve     changes and symptoms in patients taking mesalazine compare to those taking the placebo.   "
214935|NCT00663260|"     The purpose of this study is to determine whether dapagliflozin is effective in the treatment     of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment   "
214936|NCT00657228|"     To determine if intravenous unfractionated heparin (with standard therapy) for treatment of     anaphylaxis results in faster time to recovery.   "
214937|NCT00657241|"     14-week single blind, double baseline, forced-titration, cross-over comparison of the cardiac     benefits of Coreg CR compared to valsartan added to existing ACE inhibition   "
214938|NCT00657254|"     The study was designed to allow for the continuation of treatment with Sorafenib as a single     agent to those patients who participated in a previous Sorafenib study that had reached its     designated end-date and who were, in the opinion of the Investigator and the Sponsor, still     benefiting from treatment.   "
214939|NCT00657267|"     Temozolomide (Temodar) is an FDA approved medication for the treatment of newly diagnosed     glioblastomas. In this study, we will be using temozolomide to treat recurrent glioblastomas.     We will be using a different dose and schedule than the FDA approved dose and schedule. The     purpose of this study is to determine if patients that have failed standard temozolomide     treatment will respond to temozolomide when given at a different dose and schedule (21 days     every 28 days).   "
214940|NCT00657280|"     This study will investigate the effects of sitagliptin, a medicine commonly used to treat     type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure     which is not due to heart attacks. We hope to determine whether improving the heart's ability     to use glucose in the blood may help improve the function of the heart as well. If so, this     may suggest that even people who do not have frank diabetes but who do have heart failure may     benefit from using this medication.      This study will also investigate the effect of sitagliptin on the body's use of sugar, and of     the effect of sitagliptin on blood flow to the heart.   "
214941|NCT00657293|"     Patients with chronic lung disease often report shortness of breath when they use their arms     for simple activities of daily living such as dressing, lifting, shaving, bathing and     brushing their hair and teeth. The best type of arm training for these patients is still     unknown.      The objectives of this study are to:        -  develop a feasible and safe arm training program (ATP) for these patients;        -  examine the effects of this ATP on quality of life, arm function, arm exercise capacity          and symptoms during activities of daily living;        -  examine the effects of ATP on breathing responses during arm exercises.   "
214942|NCT00657306|"     Relative adrenal insufficiency (RAI) is an well known condition in patients with septic     shock. Liver failure (including chronic liver failure)and sepsis are both characterized by     hyperdynamic circulatory failure (with low arterial pressure) and high levels of     pro-inflammatory cytokines.      Hydrocortisone has been shown to have a beneficial effect on clinical outcome. The aim of     this study is to evaluate the incidence of RAI in the different settings of ascites in     cirrhosis and the usefulness of hydrocortisone in this context.   "
214943|NCT00657319|"     This observational study is conducted in Europe. The objective of this retrospective     observational cohort analysis is to assess the changes of glycaemic control and quality of     care in those Type 2 diabetic patients who were previously treated with Mixtard® insulins     after 6 months of their switch to analog premix insulin NovoMix® 30 therapy.   "
214964|NCT00657605|"     This study will test the hypothesis that leptin contributes to the regulation of the dynamics     of human endocrine function.   "
220145|NCT00726128|"     To prospectively collect radiographic and outcome data on patients who are having cervical     spine fusion surgery with the VueLock™ Anterior Cervical Plate System   "
214944|NCT00657332|"     This research involves the study of neuroendocrine tumors in order to better understand how     the disease grows and spreads. This study requires will use tissue collected from from     biopsies performed during your regular medical care (i.e. tissue leftover after your     diagnosis has been made) and/or blood and urine samples. This study may lead to the     development of special materials that could be used, in the future, to treat neuroendocrine     tumors or to follow the response of neuroendocrine tumors to treatment   "
214945|NCT00657345|"     Significant progress has been made in the treatment of women with Her2 positive breast cancer     who are treated with trastuzumab, a humanized monoclonal antibody that inhibits Her2. Despite     this progress not all patients with Her2 positive metastatic breast cancer respond to     trastuzumab and patients with metastatic disease who do respond usually develop progressive     disease during treatment with trastuzumab. The mechanism of such resistance is unknown. We     propose to investigate the mechanism of trastuzumab resistance in Her2 positive breast     cancer. The hypothesis to be examined in the basic science section of this study is that     IRS-1 and IRS-2 are modifiers of HER2 signaling and that these adapter proteins could be     predictive indicators of treatment response to Herceptin in patients that are candidates for     this targeted therapy. The connection between IRS-1 and IRS-2 expression and Herceptin     response and clinical outcome in HER2 positive human breast tumors will be evaluated to     determine if IRS expression correlates with resistance to Herceptin therapy and with the     aggressive behavior of these tumors. This study will establish if the IRS proteins influence     HER2 function in tumors and if they are predictive markers for evaluating treatment options     for HER2 positive patients.   "
214946|NCT00657358|"     The purpose of this study is to study if lidocaine, given intravenously, reduces pain.   "
214947|NCT00657371|"     The purpose of this study is to demonstrate efficacy of the Avantis Third Eye Retroscope     auxiliary imaging system.      The primary objective of this study is to assess the degree to which incorporating the Third     Eye Retroscope auxiliary imaging system in a screening colonoscopy setting results in the     detection of additional polyps.      Specifically, the primary goals are to estimate (1) the proportion of polyps detected under     this protocol that would have been missed without the Third Eye Retroscope, and (2) the     proportion of patients found under this protocol to have polyps who would have incorrectly     been classified as polyp-free had the Third Eye Retroscope not been used.   "
214948|NCT00657384|"     Blood loss was reported as a prognostic risk factor of morbidity and overall survival after     hepatic resection. The aim of this study prospective randomized was compare the efficacy of     the administration of tranexamic acid versus placebo to reduce perioperative bleeding after     major hepatectomy (> 3 hepatic segments).   "
214949|NCT00657397|"     The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved     through the possibility of prescribing buprenorphine in primary care has been successful in     reducing HIV prevalence among drug users but still inadequate for reducing the spread of HCV.     To date, methadone in France can only be initialised in drug centres but GPs can prescribe     methadone after stabilisation of dosages.      This study was born as an answer to a request from the French Minister of Health that     supports the initialisation of methadone in primary care in order to improve coverage by OST     (now 70%) in drug users.   "
214950|NCT00657410|"     RATIONALE: Drugs, such as prednisone and dexamethasone, may change the immune system and be     an effective treatment for primary immune thrombocytopenic purpura. It is not yet known which     drug is more effective in treating primary immune thrombocytopenic purpura.      PURPOSE: This randomized phase III trial is studying high-dose dexamethasone to see how well     it works compared to standard-dose prednisone in treating patients with newly diagnosed,     previously untreated primary immune thrombocytopenic purpura.   "
214951|NCT00657423|"     To study the impact of endostar combined with docetaxel and cisplatin on the angiogenesis of     non-small cell lung cancer, patients will be randomly assigned to the group one (endostar     combined with docetaxel and cisplatin) and group two (docetaxel and cisplatin).        -  The serum concentrations of Endostatin,VEGF and bFGF are determined.        -  Blood circulating endothelial cells (CECs) and circulating hematopoietic progenitor          cells (CPCs) will be measured by flow cytometer.        -  Statistical analysis will be applied to study the relationship between the levels of          Endostatin, VEGF, bFGF, CECs and CPCs and the clinical outcomes such as objective          response rate(ORT), time to progression (TTP), mean survival time(MST), toxicity and          quality of life (QOL).   "
214952|NCT00657436|"     The purpose of the study is the evaluation of multiple biomarkers related to acute coronary     syndromes, including myeloid-related protein 8/14 (MRP 8/14), along with established clinical     markers, for early diagnosis and risk stratification in patients presenting with acute chest     pain at the emergency department.      Study hypothesis: MRP 8/14, alone or together with other established or new biomarkers,     increases the earliness, sensitivity, and specificity of diagnosing acute coronary syndromes.   "
214960|NCT00657540|"     The purpose of this study is to test the effectiveness and safety of a new antivenom called     Analatro® for treating black widow spider bites in patients who present to a hospital     emergency room within 24 hours of symptom onset. This study will be a phase III,     multi-center, double-blind, randomized controlled study that takes place in emergency     departments. The primary aim of this study is to determine the proportion of patients in     which pain control was not achieved by 48 hours post treatment. Secondary aims are as     follows: 1) a reduction in pain intensity at the end of the treatment phase compared to     baseline; 2) the proportion of patients with a clinically significant decrease in pain     intensity at 30 minutes post-treatment; 3) the proportion of patients in which drug-related     adverse events occurred; and 4) to determine if serious, drug-related adverse events in     Analatro-treated patients occurred at a rate greater than one in 10 (10%).   "
214961|NCT00657553|"     To evaluate whether using the drug bortezomib at the start of remission will prevent relapse     for a longer period of time.   "
214962|NCT00657566|"     The major hypothesis to be tested is that the treatment of intraabdominal infections that     have been adequately treated operatively or by percutaneous techniques with three to five     days of antibiotics will result in outcomes equivalent to the current standard where     treatment is carried out until the patient has returned to normal (normal white blood cell     count, temperature, and intestinal function), and that patients treated for three to five     days will receive fewer days of antibiotics than the control group that has traditionally     received seven to 14 days of treatment.   "
214965|NCT00657618|"     Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the     world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a     threat for military soldiers in areas where this disease is found. Sodium stibogluconate     (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND)     product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and     visceral leishmanias. This drug is not licensed for commercial use in the United States     because of very limited need for the product in the U.S.A. The primary objective of this     protocol is to collect safety and efficacy data on the use of Pentostam for treatment of     laboratory-confirmed leishmaniasis with SSG 20mg/kg/d IV for 10 days or 20 days and visceral     and mucocutaneous leishmaniasis with SSG 20mg/kg/d IV for 28 days.   "
214966|NCT00657631|"     Symptoms of schizophrenia have historically been treatment resistant despite advances in     psychopharmacology. Acceptance and Commitment Therapy (ACT) has been shown through some     preliminary research to be effective with psychotic symptoms (Bach & Hayes, 2002). ACT is     considered part of the third wave of CBT along with Dialectical Behavior Therapy (DBT;     Linehan, 1993) and Mindfulness-based Cognitive Therapy (MBCT; Segal, Williams, & Teasdale,     2001). The target of change in ACT is acceptance of symptoms as experiences that a person can     have without experiencing distress, and while living a life in accordance with one's values.      The current study assessed the effectiveness of ACT (8 sessions) for delusions. Participants     received treatment as usual throughout the study. The intervention followed the protocol of     ACT described in Hayes, Strosahl and Wilson (1999) in which treatment will consist of     building acceptance, willingness, and commitment to change, clarifying values, defusion of     thoughts and feelings, as well as defusion of self. These therapeutic aims attempted to be     achieved by the practice of various exercises in and out of session as well as the discussion     of various metaphors within session. It was hypothesized that participants will exhibit     decreased distress due to delusions, decreased delusional conviction and a reduction of     overall anxiety levels from participants' baselines.   "
214967|NCT00657644|"     To find out more information on how effective and safe vardenafil is at treating impotence in     men living in Russia.   "
214968|NCT00657657|"     In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at     0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for     immunological memory to hepatitis B vaccine via assessment of the response to a vaccine     challenge dose.   "
214969|NCT00657670|"     This research project will compare two methods of correcting refractive error (long or     short-sightedness) with spectacle lenses. The primary outcome is the proportion of the     population requiring spectacle correction who's needs are met through each scheme. Secondary     outcomes are the cost effectiveness of these schemes and development of guidelines for     identification of those amongst the population suitable for 'ready-made' spectacles.      There are two sites involved in this research. Those with uncorrected refractive error will     be identified by their distance vision. Those who have impaired vision (at least 20/40) which     improves with spectacles will be invited to participate in this research. Participants will     be randomly allocated to one of two groups. The first group will receive spectacles with full     correction in both eyes and the second group will receive spectacles from a limited     inventory. The two schemes will be compared by how many people continue to use the     spectacles, vision with the new spectacles, change in the level of visual functioning and     quality of life after wearing new spectacles for one month. At the one month visit, if the     spectacles provided are not useful, one new pair of custom spectacles will be dispensed.   "
214970|NCT00657683|"     The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity     of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect     humans from infection.   "
214971|NCT00657696|"     Within every primary care clinic is a small team of people who provide care to a group of     patients who consider this clinic to be their medical home. Rapid advances in medical     knowledge and technology require that these teams constantly adapt so that they can provide     the best care to their patients. The goal of this study is to examine how people in these     primary care teams learn and relate to each other as they change an adapt. This will be done     by observing and interviewing people who work in these teams and by giving them and their     patients a survey to fill out. We will then look at the performance of these clinics to see     if it is related to how they learn and the quality of their relationships. Our ultimate goal     is to design effective interventions that will improve the quality and outcomes of care     received by Veterans in primary care outpatient clinics within the VHA.   "
214973|NCT00657722|"     In order to improve effectiveness of the surgical operation thanks to a reduction in the rate     of failure, this study will allow us to identify predictive angiographic and CT finding of     surgical failure, starting from standardized reading grids, in order to have a better     selection of the operable patients.   "
214974|NCT00657735|"     The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in     subjects with bipolar depression , currently treated with mood stabilizer and previously     unsuccessfully treated with antidepressant medications   "
214975|NCT00657748|"     The aim of this study is to determine whether oral supplementation with lithium and acetate     may improve the biological and clinical prognosis in patients with Canavan Disease.   "
214976|NCT00657761|"     The metabolic effects of T-20 are not completely known, since the drug is used in combination     with other antiretroviral agents. A short-term study in healthy volunteers, with a     double-blind crossover design vs. placebo will illustrate if there may be some direct     metabolic effects without the influence of HIV infection and the concurrent use of other     drugs.   "
214977|NCT00657774|"     The medications being used in this study are individually approved by the Food and Drug     Administration (FDA). The medication under investigation is a combination of the two     medications in one inhaler. The purpose of the study is to determine how the medication     affects the amount, if any, of cortisol produced by the adrenal glands.   "
214978|NCT00663273|"     The purpose of this study is to demonstrate the safety of the gynecological formulation in     normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.   "
214979|NCT00663286|"     The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with     acne vulgaris.   "
214980|NCT00663299|"     To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the     treatment of aneurysms.   "
214981|NCT00663312|"     Parkinson' disease is a neurodegenerative disorder characterised by bradykinesia, rigidity,     rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine     agonists usually leads to a dramatic improvement of symptoms, but disease progression     nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus     (STN) leads to a spectacular clinical improvement in patients with motor complications and is     now considered as the gold standard surgical treatment.      However, this surgery induces a post-operative body weight gain which may limit the benefits     of this technique and induce critical metabolic disorders such as profound alterations in the     central control of energy metabolism. Previous data seems to show that glucose metabolism is     also altered.      The aim of this prospective study was to identify if the STN stimulation could modify glucose     metabolism regulation especially the endogen glucose production (by liver) Hypothalamus is     able to detect glucose concentration variations and to control/adjust glucose levels by     modulating the hepatic glucose production. As hypothamus and STN are anatomically closed, we     hypothesise that the STN stimulation could modulate the hypothalamus function and     consequently modify glucose production.   "
214982|NCT00663325|"     The purpose of this study is to demonstrate the safety of the gynecological formulation in     normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.   "
214983|NCT00663338|"     The aim of this study is to assess the effect of the drug rotigotine on the syndrome of     hemispatial neglect and motor deficits following strokes affecting the right hemisphere of     the brain.   "
214984|NCT00663351|"     This Post-Approval study is prospective follow-up study designed to evaluate the long-term     safety and effectiveness of the Reflection Ceramic Acetabular System.   "
214985|NCT00663364|"     Dry skin is a physiological condition and is characterized in contrast to greasy skin by     roughness, desquamation and lack of brightness of the skin surface. Subjectively, feelings of     tension, burning and itching can occur. Dry skin needs special care due to its structural and     functional characteristics.We monitor an application test the Dermatocosmetics Oilatum     Physiogel AI Lotion and Physiogel Lotion. This is to be accomplished with patients having dry     skin. The influence on the roughness of skin, desquamation, feeling of tingle, burning and     itching should be documented. If sleep quality is disturbed by tingle or itch, this will be     monitored, too.   "
214986|NCT00663377|"     The purpose of this study is to evaluate the effects of losartan, an ARB, on glucose     metabolism and inflammatory cytokines in CHF patients treated with ACE inhibitors.   "
214987|NCT00663390|"     The purpose of this study is to demonstrate the safety of the gynecological formulation in     normal and usual usage condition of Dermacyd Delicata Pocket.   "
214988|NCT00663403|"     Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant     microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU)     considering the severity of illness and high risk for infection within this hospital     environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of     ICU patients who develop acute renal failure will require some form of renal replacement     therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most     common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer     periods of time. The current data demonstrating the ability of continuous hemodialysis to     remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is     to determine the extent of daptomycin removal from critically ill patients receiving     continuous hemodialysis. Findings from this trial will be used to develop new dosing     recommendations for daptomycin in continuous hemodialysis.   "
214989|NCT00663416|"     Primary objective: To assess the neurological outcome in acute ischemic stroke patients     treated with NTx™-265, when compared with patients given a placebo control.      Secondary objective: To assess the safety and tolerability of NTx™-265 when given to acute     ischemic stroke patients.   "
214990|NCT00663429|"     This study is an extension study to the Callisto protocol CP-106. Subjects must have     completed all 12 treatment cycles of CP-106 without disease progression as per RECIST     criteria,to be eligible to to be enrolled in this study. This study will evaluate the safety     and efficacy of atiprimod treatment in patients with low to intermediate grade neuroendocrine     carcinoma who have metastatic or unresectable local-regional cancer and who have either     symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or     progression of neuroendocrine tumor(s).   "
214991|NCT00663442|"     Children between 6-17 are evaluated for ADHD and and a blood sample is obtained for DNA     extraction. If eligible, they participate in a 4 week, double blind, placebo controlled trial     with weekly switches. In randomized order, children receive 18, 36, 54 mg. OROS     methylphenidate and placebo. Each week, parent report measures, clinical interviews, and     safety assessments are conducted.      Hypothesis: Efficacy and adverse events will be dose dependent. Dopamine Transporter Genotype     will predict response   "
214992|NCT00663455|"     The purpose of this study is to determine if a safe reduction of cyclosporine A in pediatric     and adolescent patients with stable renal graft function, reduces signs of     calcineurin-inhibitor toxicity.   "
214993|NCT00663468|"     The purpose of this study is to determine the performance and efficacy during 6 and 12 month     post operation.        1. determine changes in patient pain level        2. determine changes in patient functionality        3. determine changes in patient life quality   "
214994|NCT00663481|"     The purpose of this study is to determine the safety and tolerability of CoFactor in healthy     subjects.   "
214995|NCT00663494|"     The purpose of this study is to evaluate the production of MMP in failing hearts.   "
214996|NCT00663507|"     The purpose of this research is to better characterize the components and mechanisms of the     immune systems of persons with sickle cell disease who have had a kidney transplant and are     immunosuppressed. If we can improve our scientific understanding of the fundamental     mechanisms involved in patient outcomes, we can potentially maximize the benefits that we     seek from transplantation in sickle cell patients with end stage renal disease.   "
215076|NCT00665626|"     The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor,     R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment     of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy.   "
214997|NCT00663520|"     The purpose of this study is to determine if women with chest pain and clean heart blood     vessels have impaired blood flow to the heart due to problems with the small blood vessels     that provide blood and oxygen to the heart. Impairment in the small blood vessels will be     tested using ultrasound pictures of the heart, called myocardial contrast echocardiography.     Since these small blood vessels are not seen in a coronary angiogram, which is an x-ray of     the heart vessels using a dye containing iodine injected in the heart vessels, the problem     may remain undiagnosed in women until the heart muscle becomes severely damaged.      A second purpose is to identify if there is a common trait in the population of women with     this tiny blood vessel dysfunction, which will be investigated by checking blood levels of     certain chemical and hormones related to heart disease. Finally, we would like to investigate     the relationship between depression and stress, and heart disease. We will do this by     measuring cortisol (a hormone that serves as a measure of stress) and administering     questionnaires that help to identify depression and stress.   "
214998|NCT00663533|"     The purpose of this research study is to study an experimental vasectomy device called the     Vas-X. This is an experimental study of this new approach to vasectomy.   "
214999|NCT00663546|"     This study, conducted by the National Center for Parasitology, Entomology and Malaria Control     of Cambodia s Ministry of Health and the National Institute of Allergy and Infectious     Diseases, will explore whether the following factors confer protection against malaria and     associated anemia: certain blood groups, the hemoglobin E variant, G6PD-deficiency and     alpha-thalassemia. Malaria is caused by parasites (P. falciparum and P. vivax) that are     transmitted to humans through mosquito bites. This protocol includes two studies, a cohort     study and a P. vivax collection study.      Individuals are eligible for enrollment in the studies as follows:      Cohort study:      Residents of all ages of Kandal, Ekapheap and Sangkumthmey villages (Thmar Da commune) who     plan to remain in Thmar Da commune for the next 5 years.      P. vivax collection study:      2 years of age and older      Participating in NIAID protocol 05-I- N210 ( Severe Malaria and Anti-malarial Drug Resistance     in Cambodia ) and diagnosed with P. vivax malaria      Participants undergo the following procedures:      Cohort study:      Baseline evaluation, including the following:        -  Collection of demographic information        -  Malaria history, temperature measurement and review of current symptoms, if any        -  Blood draw of 300 microliters        -  Additional blood draw of 10 milliliters in selected adults 18 years of age and older      Treatment with artesunate-piperaquine at a commune health post for subjects who develop     malaria      Contact once a year for 5 years to determine continued residency in Thmar Da commune      P. vivax collection study:        -  Medical history and physical examination        -  Hemoglobin level measurement        -  Blood draw        -  Treatment with chloroquine        -  Blood draw 3 to 5 weeks after treatment in some patients 18 years of age or older   "
215000|NCT00663559|"     The purpose of this trial is to determinate the efficacy of Sunitinib in patients with renal     cells carcinoma metastasic or locally avanced in patints not candidates to inicial curative     nefrectomy.   "
215001|NCT00663572|"     Influence of neonatal nutrition and growth on psychomotor development of 2 years preterm     infants.-Joint influence of environmental factor (early nutrition) and genetics factors on     feeding behaviour setting- up in a particular population of infants of whom nutrition and     life conditions during first weeks of life were purely controlled.   "
215002|NCT00663585|"     Participants completing training in intensive meditation and continuing frequent practice for     one year would experience reduced frequency, duration and severity of headaches along with     improved awareness of the triggers of their symptoms, improved quality of life and mental     health, improved heart rate variability, and reduced inflammation.   "
215003|NCT00663598|"     Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily     life conditions in a large number of subjects with erectile dysfunction (ED)   "
215004|NCT00664677|"     This study is designed to determine the safety, maximum tolerated dose,dose limiting toxicity     of Terameprocol(EM-1421)and determine the pharmacokinetics (clearance from the blood)of     Terameprocol(EM-1421)given as intravenous infusion three times a week in patients with     leukemia.   "
215005|NCT00664690|"     Sixty adults having shoulder and forearm surgery will receive either placebo or celebrex     started preoperatively and continued for 3 days. Rescue medications required as well as pain     scores will be assessed using a patient diary to evaluate the effect of celebrex in     controlling transitional pain   "
215006|NCT00664703|"     The study will evaluate the effectiveness of the nonstimulant medication lobeline in     improving symptoms of attention deficit hyperactivity disorder in adults.   "
215007|NCT00664716|"     Safety and efficacy of BG9924 in RA participants that have had an inadequate response to     disease-modifying anti-rheumatic drug (DMARD) therapy.   "
215021|NCT00664898|"     This is an open-label, multicenter, Phase Ib study to be conducted at approximately eight     sites in Europe and the U.S. designed to evaluate the safety, pharmacokinetics, and activity     of SGN-40 when combined with bortezomib in patients with multiple myeloma that is relapsed or     refractory after at least one prior systemic treatment regimen.   "
215253|NCT00667758|"     The purpose of this study is to compare the safety and efficacy of gonadotropin-releasing     hormone (GnRH) antagonist therapy versus placebo in patients with moderate to severe     rheumatoid arthritis.   "
215008|NCT00664729|"     Reductions in fat oxidation and resting metabolic rate (RMR) are associated with normal aging     and are accelerated with menopause. As a result, postmenopausal women have an increased risk     of abdominal obesity and ultimately the metabolic complications that lead to the insulin     resistance syndrome and its associated risks (hyperlipidemia, type 2 diabetes, and coronary     heart disease). Thus, there is a need to determine the most successful treatment to reduce     visceral obesity in postmenopausal women. The purpose of this study is to determine if     dietary-induced weight loss alone and/or weight loss combined with exercise at low and high-     intensities differentially affect the reduction in visceral adipose tissue in postmenopausal     women with abdominal obesity.   "
215009|NCT00664742|"     This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release     (80 mg once daily) in patients with metabolic syndrome   "
215058|NCT00665392|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) together with cetuximab may kill more tumor cells.      PURPOSE: This phase II clinical trial is studying how well cetuximab given together with     combination chemotherapy works in treating patients with stage III or stage IV oropharynx     cancer that can be removed by surgery.   "
215010|NCT00664755|"     This component builds directly upon the results of the previously funded project in     systematically investigating the impact of short-term ovarian hormone fluctuation on females     as they try to quit smoking with the aid of either transdermal nicotine patch (TNP) or     varenicline. Each participant will receive a standardized impulsivity evaluation and a     laboratory-based cue reactivity assessment before the initiation of smoking cessation.     Progesterone and estrogen levels will be measured at each of nine visits, thereby providing     an index of reproductive hormone variation over the course of each participant's quit     attempt. This novel approach of integrating a human laboratory cue reactivity paradigm     directly with a treatment outcome study will permit us to assess whether or not smoking cue     reactivity has predictive utility with respect to cessation outcome. Subjects will be     randomized to receive one of two active pharmacotherapeutic interventions for smoking     cessation: TNP vs. varenicline in a randomized, single-blind, double dummy design. While TNP     has demonstrated modest efficacy in improving smoking cessation outcomes, there is some     evidence that its efficacy may be more robust in men as compared to women. This project will     provide important information about a) the impact of ovarian hormone levels on smoking     cessation outcomes, b) the relationship between smoking cue reactivity and smoking cessation,     and c) comparison between a new pharmacotherapeutic agent and TNP in women.   "
215011|NCT00664768|"     This study involves the use of 2 different Neocate formulas: a control formula called Neocate     Infant and a test Neocate formula. These kinds of formulas are for use in children from birth     to 8 months of age with Cow Milk Allergy (CMA), other food allergies, and other     gastrointestinal disorders. The purpose of this study is to compare the control and test     Neocate formulas for safety, tolerability, and effectiveness (in promoting growth) when used     in subjects with CMA.      This study will also look at the test Neocate formula to see if it is hypoallergenic when     used in subjects with CMA.   "
215012|NCT00664781|"     RATIONALE: rucaparib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying the side effects and best dose of rucaparib and to     see how well it works in treating patients with locally advanced or metastatic breast cancer     or advanced ovarian cancer.   "
215013|NCT00664794|"     Surgical repair of full-thickness tears of the rotator cuff is a controversial issue, with     several procedures currently being used to treat the tear. The two most common treatments at     this point in time are arthroscopic cuff repair with and without acromioplasty. However, an     arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as     one that includes acromioplasty, but without threatening the shoulder stability that is     provided by the acromion and coracoacromial ligament. This prospective study examines the     hypothesis that appropriate shoulder function can be restored through execution of the     traditional arthroscopic cuff repair without acromioplasty.   "
215014|NCT00664807|"     To generate a list of potential genetic markers that correlate with an increased risk of     life-threatening arrhythmias.      To evaluate ECG-based risk markers such as heart rate variability and T-wave Alternans for     their association with arrhythmic events.   "
215015|NCT00664820|"     The purpose of the present study is to examine the utility of probiotics as an adjunctive     therapy (in addition to patients' pharmacotherapy) for the treatment of Rheumatoid Arthritis.      We hypothesize that specifically selected probiotics, Lactobacillus rhamnosus GR-1 and L.     reuteri RC-14, can alleviate symptoms of RA and thereby increase the daily activity of these     patients.   "
215016|NCT00664833|"     This is a multicentre, cluster-randomized, open-label flexible dose study with a 2x2     factorial design with administration of vardenafil at a dose of 5, 10 and 20 mg doses in     males with erectile dysfunction.The treatment period is for 12 weeks, after a 4 week     unmedicated period for subjects taking ED medication. For ED treatment-naïve subjects (ie,     previously not treated with ED medication), the unmedicated period can be only 2     weeks.Approximately 150 investigational centres may be utilised with approximately 10     subjects screened and entered into a 4 week treatment free period at Visit 1 to subsequently     enroll approximately 1380 subjects to therapy. Each centre should enroll 10 subjects. Sites     should try to recruit approximately 50% of subjects who have not previously tried oral PDE5     inhibitor therapy for erectile dysfunction. An attempt should be made to enroll subjects     whose partners are interested in being involved.Sites will be randomized in a 1:1:1:1 ratio     to receive either the education intervention at the Primary care Physician (PCP) level, at     the subject level, both levels or no intervention (usual care). The PCP education program is     an accredited CME program and included a comprehensive overview on the screening and     diagnosis of ED, the available treatment options and appropriate treatment selection, as well     as subject and partner counseling. The subject education was a two-pronged approach which     included physician-to-subject instruction and a direct-to-subject education method. After the     unmedicated period, treatment was initiated with vardenafil 10 mg tablets for 4 weeks. This     will be followed by a flexible dose titration period of 4 weeks during which subjects may     maintain the previous dosage regimen or will step up to 20 mg of vardenafil or will step down     to 5 mg vardenafil. There is a final 4 week treatment period where the previous dosage     regimen is either maintained, increased or decreased by one step according to the three     applicable dosage strengths of vardenafil (5, 10 or 20 mg). The highest applicable dosage     regimen of 20 mg vardenafil will not be exceeded. A 24 hour follow-up phone call is required     within 24 hours of the last dose of vardenafil to collect data concerning serious adverse     events, if needed.   "
215017|NCT00664846|"     The purposes of the study are to analyse the cross-section data of secondary stroke     prevention in China and to carry out a standard medical management including medicine and     interactive education program,and to evaluate the efficacy and safety of the standard medical     management in secondary stroke prevention.   "
215018|NCT00664859|"     The current study is designed to test the long-term (12-month) safety and efficacy of     LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia   "
215019|NCT00664872|"     The purpose of this study is to determine the case manager are effective in the treatment of     suicide attempters.   "
215020|NCT00664885|"     This study is a randomized controlled trial to test whether Culturally Sensitive     Collaborative Treatment (CSCT) would improve the outcome of depressed patients visiting     non-psychiatric settings in Taiwan.   "
215022|NCT00664911|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating     older patients with solid tumour.   "
215059|NCT00665405|"     Pregnancy promotes respiratory system's restrictive component. This study observes the     generation of atelectasis during labor.   "
215077|NCT00665639|"     To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin     for the treatment of esophageal candidiasis   "
215307|NCT00668460|"     The purpose of this study is to demonstrate the absence of irritation potential (primary     dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the     product Dermacyd Pocket BR.   "
215023|NCT00664924|"     The Remote Physiological Monitoring System (RPM™) is a wireless technology for physiological     monitoring. The RPM™ is designed to capture, transmit and remotely monitor the vital signs of     a patient or group of patients. The RPM™ allows the patient to carry an unobtrusive unit and     sensor array, which is able to store and/or forward its data via existing communication     networks. This data is archivable and can be made available to a monitoring station or     stations. This approach obviates the need to provide new and expensive infrastructure to     support the system since it is designed to 'piggy-back' on the existing network.      A major clinical advantage of the RPM™ and the principal reason why it may offer a benefit to     patients, is that it provides continuous remote monitoring of vital signs, in contrast to the     current situation for ward patients, where there is intermittent vital signs monitoring. This     is a major advantage for patients and hospital staff, since there is increasing evidence that     demonstrate early recognition and treatment of clinical events, e.g., shock, can save lives;     the concurrent cost and labour saving is a further obvious benefit.      The RPM™ uses wireless technology to overcome the portability problems associated with     conventional patient monitoring systems. The RPM™ consists of the following system     components:        1. Physiological Monitoring Unit (PMU)        2. Data Aggregation Server (DAS)        3. Clinical Monitoring Position (CMP) To validate the RPM™ device for regulatory approval,          BRYTECH will evaluate the RPM™ in a clinical setting, thereby ensuring that the system          is trustworthy and acceptable to health professionals as a monitoring system in          patients. The study proposes to evaluate the accuracy and reliability of the RPM™          compared to monitors commonly used in the medical practice under the standard conditions          of medical practice The study also proposes to evaluate notification and alarm systems,          the communications interface and non-interference with existing systems, devices,          networks and procedures as well as the incremental nursing workload associated with the          integration of the RPM™ in a clinical environment. The RPM™ and reference physiological          monitoring devices will be compared for physiological monitoring capabilities in 40          patients.   "
215024|NCT00664937|"     Exercise-induced bronchoconstriction (EIB) is a condition where airways tighten when you     exercise and may cause coughing, wheezing, or shortness of breath. In many patients, this     condition can cause lung function to drop making it harder to breath. An instrument called a     spirometer is commonly used to measure lung function. This traditional means of assessing     lung function in asthma is limited in its ability to provide information as to where in the     lung the tightness is. Hyperpolarized helium magnetic resonance imaging (3He MRI) is a novel     way to see the where air is going in the lungs using an MRI and special gas. The ability to     see where the air can and cannot reach in the lungs may help show more accurately if a     medication is working to make the asthma better. The purpose of this study is to examine     patients with EIB in order to see if 3He MRI provides a better way to measure lung function.     Patients will be given either montelukast sodium, a drug to improve the ability to breath     with EIB, or placebo and then put on a treadmill to induce an occurrence of airway     constriction. The patient's lung function will be measured more than once using both the     spirometer and the 3He MRI.   "
215025|NCT00664950|"     Elderly patients with an intertrochanteric hip fracture will be randomized to receive either     a sliding hip screw (SHS) (control group) or InterTAN intermedullary nail (IMN) (experimental     group) for surgical fixation of their hip fracture. This study will assess functional and     mortality outcomes for elderly patients with hip fractures.   "
215026|NCT00664963|"     The purpose of this study is to compare the effectiveness of the treatment with     balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX     uncoated stent in patients with ischemic infrapopliteal arterial disease.   "
215027|NCT00664976|"     This project is a randomized controlled trial of electroconvulsive therapy (ECT) compared to     treatment as usual (TAU) in the treatment of treatment resistant depression (TRD) in bipolar     disorder. The purpose of the trial is to document the effect size, relative effect size and     adverse effects of ECT in this condition. A specific purpose is to gain more knowledge about     the effect on cognitive function.   "
215028|NCT00664989|"     Hypothesis: What is the difference in disease specific quality of life between patients who     receive a humeral surface replacement hemiarthroplasty verusu a conventioanl stemmed     hemiarthroplasty   "
215029|NCT00665002|"     The purpose of this study is to determine whether the WT-1 vaccine causes an immune response     and is safe. The WT-1 vaccine is made up of protein pieces that the patient's immune system     can recognize as abnormal.   "
215030|NCT00665015|"     Pleural effusion is a common complication of cardiac surgery. The aim of this study was to     determine the prevalence, characteristics and determinants of clinically significant pleural     effusions, defined as those requiring therapeutic pleural drainage.   "
215031|NCT00665028|"     After surgery, patients who have cardiogram changes consistent with a lack of oxygen to the     heart muscles, also known as myocardial ischemia, have been found to have 9 times the chance     of having an event such as a heart attack during the subsequent 30 days. It is not known if     monitoring and treating ischemia will prevent events such as heart attacks. It is not known     if such monitoring and treatment can be done on the regular surgical wards. In this pilot     study, we hope to demonstrate that such a study is feasible, and the maintenance of blinding     is possible. The primary outcomes are to show that such monitoring after surgery is possible     in ≥ 95% of patients, to show that response and treatment to such ischemia in ≤ 1 hour is     possible in ≥ 90% of patients, and that blinding between the standard and active treatment     groups is possible for 50% ± 1 s.d.. With the pilot study data, if successful, we will be     applying for peer-reviewed funding for a full study.   "
215032|NCT00665041|"     Assess the tolerability of quinagolide 200 μg/day in a dose-titration regimen in oocyte     donors undergoing controlled ovarian hyperstimulation and at risk of developing OHSS     Secondary Objectives      Estimate the effects of a quinagolide dose-titration regimen compared to placebo in     peritoneal fluid accumulation, incidence of ascites, OHSS symptoms and clinical laboratory     parameters of haemoconcentration   "
215033|NCT00665054|"     Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male     subjects suffering from erectile dysfunction as compared to placebo- To assess the influence     of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile     dysfunction following treatment with vardenafil as compared to placebo   "
215045|NCT00665223|"     The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic     treatment of Huntington's disease.   "
215133|NCT00666367|"     This project aims to explore the relationship between Vitamin D deficiency and COPD     progression via a prospective randomized placebo-controlled study. For this purpose, study     was powered to 120 patients hospitalized with an exacerbation of COPD randomly assigned to a     monthly oral dose of Vitamin D versus placebo. Taking into account dropouts, 182 patients are     randomized during the course of the study   "
215074|NCT00665600|"     To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of     treatment in COPD.   "
215075|NCT00665613|"     The purpose of this study is to determine if osteoporosis is an unrecognized complication of     chronic anticoagulation with warfarin.   "
215034|NCT00665067|"     Researchers will use abnormal blood and/or bone marrow cells, or materials derived from these     abnormal cells, like DNA, RNA, protein or plasma, in laboratory studies. Toenail clippings     will provide normal material like DNA for comparison with the abnormal material derived from     the blood and/or bone marrow. The results of these studies will be correlated with subjects'     disease symptoms and response to their experimental treatment. The MPD-RC researchers are     interested in studying molecules from the blood and bone marrow, the exact molecules changing     over time with the investigators choosing only the most promising for investigation.      The investigators are attempting to better understand the causes of MPD and to develop     improved methods for the diagnosis and treatment of these diseases. These syndromes carry a     high risk of developing leukemia. It is important to continue to learn more about these blood     cancers and to learn more about the effectiveness and potential side effects of various     treatments. It is believed that further basic knowledge about these cancer cells as well as     the effects of treatment will lead to the improvement of current therapies and the     development of entirely new treatments for these diseases. The MPD-RC is hoping to determine     if a number of laboratory tests (biomarkers) will allow for the prediction of response in     future patients to the treatment they would receive.   "
215035|NCT00665093|"     This trial is conducted in Europe. The aim of this observational study is to evaluate the     glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under     normal clinical practice conditions.   "
215036|NCT00665106|"     Evaluation of safety and tolerability of a single injection of NOVA63035 Corticosteroid     administered at one of four doses in patients with diabetic macular edema (DME) secondary to     diabetic retinopathy   "
215037|NCT00665119|"     Sedation is widely used in mechanically ventilated patients. Propofol, benzodiazepines and     opioids are the most used drugs. The study hypothesis is that sedation with remifentanil (an     opioid drug) could improved respiratory pattern and effort in mechanically ventilated     patients with rapid shallow breathing or high respiratory rate.   "
215038|NCT00665132|"     This study is being done to see how well a new investigational medical device, the StimRouter     (STR) System, will work to treat the chronic pain in people who have failed previous     treatments for Carpal Tunnel Syndrome (CTS) pain, including surgery. These people have been     treated for CTS pain before including surgical carpal tunnel release, but without good     results, and they are still having pain. The study will look at both the good and bad effects     of the StimRouter System for treating this kind of pain and as a general peripheral nerve     stimulation device for treating chronic pain. The study will also help to understand other     possible uses for the StimRouter System.   "
215039|NCT00665145|"     The primary and secondary objectives of this study are:      Primary: To evaluate stem-cell-mobilization in subjects with diabetic neuropathy receiving     SB-509. Stem cell mobilization will be assessed by evaluating the presence of stem cells     circulating in peripheral blood.      Secondary: To evaluate the safety of SB-509 in subjects treated with SB-509 with diabetic     neuropathy; and to compare the effect of SB-509 versus placebo on a pre-defined     multi-endpoint analysis that includes visual analog scale for pain intensity (VASPI), total     neuropathy score (TNS), evoked nerve conduction velocity (NCV) and quantitative sensory     testing (QST)   "
215040|NCT00665158|"     We will perform a randomized, controlled trial, the primary aim of which is to assess the     effectiveness of a behavioral-based physical activity program in the prevention and treatment     of obesity and related co-morbid conditions in a primary care setting. We hypothesize that     the prevention and/or reduction of obesity and related co-morbidities in patients randomized     to an individualized education and behavior counseling group will be greater by comparison to     those randomized to a group that receives standard care alone.   "
215041|NCT00665171|"     Background: Infertility affects up to 15% of married couples. About half are attributable to     female factors, among which anovulation is the leading cause. Some 5% of all women of     reproductive age are anovulatory due to the polycystic ovarian syndrome (PCOS). PCOS causes     also major health and cosmetic problems and significantly affects quality of life. PCOS is     associated with cardiovascular morbidity and Type 2 diabetes mellitus, but it is unclear     whether these are caused by the ovarian dysfunction or result from a common denominator.      Working hypothesis and aims: Whole genome analysis of multigenerational families in which at     least one woman is affected by PCOS may significantly reduce the numbers needed to verify the     specific genes, involved in the causation of PCOS.      Methods: Registration of multigenerational families and production of personal files with     full workup for the presence of PCOS or its absence (in the women participants). Drawing of     blood, extraction and preservation of DNA. Analysis of all informative SNPs in the genomes of     the participants on a specific microarray chip. Statistical analysis of the results.      Expected results: Verification of the loci and putative genes, associated with the appearance     of PCOS.      Importance: Elucidation of the specific genes underlying the pathology of PCOS. Probable     implications to Medicine: Paving the way for targeted treatment of the problems, associated     with PCOS, based on the clear knowledge of its underlying cause(s).   "
215042|NCT00665184|"     Parkinson disease is a degenerative neurologic condition characterized by slowness of     movement, tremor, and loss of balance control. It results in significant degrees of     disability for affected individuals. Exercise and medication management are two treatments     frequently used to treat Parkinson disease, and although some individuals benefit from these     treatments, by what effect exercise works is presently not known. We will examine muscle     structure and movement control responses to strengthening exercises and compare them to the     therapeutic response observed as a result of medication intake. This process will allow us to     better understand the mechanisms underlying the therapeutic effects of strengthening exercise     for persons with Parkinson disease.   "
215043|NCT00665197|"     Hypothesis: In the management of advanced oesophageal cancer, to determine if a shorter     regime of external beam radiotherapy (using higher daily doses, and combined with     intraluminal high dose rate brachytherapy) is not inferior in the palliation of dysphagia     than a more protracted course of external beam radiotherapy (using lower daily doses and     combined with equal intraluminal high dose rate brachytherapy).   "
215044|NCT00665210|"     Hip implants come in different sizes. Currently, surgeons predict the implant size that will     be needed using an analogue method whereby photos of the implant sizes are overlaid on the     x-rays. In this study, we propose to use a digital, computerized method of templating which     we expect will be more accurate than the overlay method.   "
215046|NCT00665236|"     Treatment of migraine continues to be a major health problem today, despite many new     pharmacological therapies. Limited clinical experience suggests that craniosacral therapy     (CST) may be effective in the treatment of headache, including migraine. The primary aim of     this proposal is to gather quality preliminary data on the usefulness of CST as an adjunct to     conventional care for patients with migraine and to determine the feasibility of a larger,     randomized clinical trial of CST in patients with migraine. Craniosacral therapists use a     technique of gentle palpation of the head, neck and spine to release restrictions in cranial     and peri-spinal tissues that are believed to contribute to a variety of health problems     including headache. It is estimated that more than 2 million visits to CST practitioners are     made each year, with more than 10 per cent of those for the complaint of headache. There has     been no rigorous research examining the usefulness of CST for patients with migraine despite     the impression of beneficial effects. Our limited preliminary data show significant,     sustained benefit of CST in a small group of patients with migraine. The First Specific Aim     is to determine the feasibility of developing a clinical trial comparing craniosacral therapy     versus low-strength static magnets (attention-control complementary therapy) as a treatment     for preventing migraine headaches. Patients with migraine, with or without aura, under care     of a neurologist will be studied. After an 8-week baseline period, they will be randomized to     one of two groups: 1) usual medical care plus 8 weeks of CST; or 2) usual medical care plus 8     weeks of attention-control complementary treatment. Primary outcome measures will include: 1)     headache-related quality of life, 2) headache frequency, and 3) perceived benefit in those     receiving treatment. The Second Specific Aim is to identify relevant secondary outcomes     associated with usual care plus adjunctive craniosacral therapy for migraine. Data collection     will include demographics, headache intensity and duration, health status, headache-related     disability, health care utilization, and medication use. The Third Specific Aim is to     identify and find solutions for potential problems in conducting a larger clinical trial to     assess the efficacy of CST for the prevention of migraine. Patients will be recruited from     the University of North Carolina Headache Clinic and from local neurological practices.     Duration of the study for each subject is 16 weeks. Length of the entire project is 2 years.   "
215047|NCT00665249|"     The purpose of this pilot study is to investigate the critical components of motivational     interviewing (MI), a psychotherapeutic intervention, in reducing heavy or problematic     drinking. The study will disaggregate MI into its component parts and test full MI compared     to MI without its directive strategies. This study will test whether the directive elements     of MI are critical or whether MI effects may be attributable solely to its Rogerian,     non-directive components. For more information, go to www.projectmotion.org   "
215048|NCT00665262|"     Ten patients 70 years and older having elective total hip/knee replacement surgery will be     recruited to receive a continuous IV infusion of naloxone and oral tramacet for analgesia.     Postoperative analgesia, satisfaction, side effects, need for rescure analgesia, and length     of stay.   "
215049|NCT00665275|"     This is an observational study aiming to study the use of complementary and alternative     medicine (CAM) drugs and methods among patients with inflammatory rheumatic diseases, at     Rheumatology clinics in western Sweden and also to investigate possible associations between     CAM using habits and other characteristics of the patients.   "
215050|NCT00665288|"     The goal of this study is to conduct a survey to better understand the factors associated     with undertaking cardiopulmonary resuscitation (CPR) training and performing CPR in an     emergency situation.   "
215051|NCT00665301|"     The purpose of this study is to compare cardiac output results obtained using the     thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted     cardiac output results obtained from the non-invasive FloWave™ 1000 device.   "
215052|NCT00665314|"     Some patients with multiple myeloma or lymphoma will need treatment with high dose     chemotherapy to treat their condition. This potent treatment will kill many of the     blood-forming cells in the bone marrow. The patient will therefore need these blood-forming     cells replaced after the chemotherapy treatment. This is done by collecting some of teh     patients own blood-forming stem cells before chemotherapy, storing them and then infusing     them into the patient after chemotherapy (in the same way as a blood transfusion is given).     The stem cells will then make their way unto the bone marrow and re-populate it. Having stem     cells collected and returned later is called an Autologous Transplant.      In most patients these blood-forming stem cells (which normally live in the bone marrow) are     mobilized into the blood stream where they are then collected by a process called apheresis     (a bit like donating blood). This process of mobilization is not always successful. In this     study patients who did not collect enough stem cells in a previous cell collection attempt to     have an autologous stem cell transplant will participate. Patients will be mobilized with     G-CSF (current standard treatment to mobilize stem cells) and the effect of adding AMD3100 to     G-CSF will be studied by comparing outcomes in patients who get G-CDF with placebo     (non-active substance which looks like AMD3100) to patients who get G-CSF with AMD3100.      AMD3100 is a member of a new class of medications called chemokine inhibitors. The drug     triggers the movement of stem cells out of the bone marrow into the blood stream. In previous     studies with healthy volunteers and cancer patients, when AMD3100 and G-CSF were used in     combination, a greater number of stem cells were mobilized into the blood stream than by     using g-CSF alone.      The purposes of this study are to measure how many stem cells can be collected, the number of     days to collect those cells and the safety of a mobilization regimen of AMD3100 with G-CSF     compared to G-CSF with placebo. If enough cells are collected to have a transplant, the study     will also evaluate how well the cells grow when transplanted.   "
215053|NCT00665327|"     This study was to assess the safety of sequential intravenous (IV)/oral (PO) moxifloxacin     (Avelox®) compared with sequential IV/PO levofloxacin (Levaquin®) in the treatment of elderly     subjects (aged &#8805; 65 years) with community-acquired pneumonia (CAP) who required initial     IV therapy. This study also included an assessment of the clinical and bacteriologic     effectiveness of both drugs.   "
215054|NCT00665340|"     This study was conducted to evaluate in adult men with erectile dysfunction (often called     impotence), the effect of vardenafil HCl on the quality of their erections. Many men     experience occasional erectile problems during their lives. The causes of erectile     dysfunction are varied and may be due to physiological or emotional reasons. This study is     designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl.     In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like     the real drug but it is not. It contains no active ingredients.   "
215055|NCT00665353|"     Insulin resistance is common in people coinfected with HIV and Hepatitis C virus (HCV) and is     associated with poor responses to treatment for HCV. Pioglitazone is an FDA-approved     medication for the treatment of type 2 diabetes. It works by increasing the body's     sensitivity to insulin. The purpose of this study is to determine whether treatment with     pioglitazone prior to HCV treatment with peginterferon and ribavirin is safe and effective in     improving the treatment outcome in insulin-resistant, HIV/HCV-coinfected people for whom     previous treatment with peginterferon and ribavirin was unsuccessful.   "
215056|NCT00665366|"     The purpose of the study is to determine whether aripiprazole provides additional clinical     benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12     weeks.   "
215057|NCT00665379|"     The purpose of this trial is to study the effect of the 3M Coban 2 Layer Compression System     (hereafter C2L) in the treatment of leg lymphedema compared to the traditional treatment with     Trico bandages.   "
215071|NCT00665561|"     The study will assess if use of maraviroc along with an optimized background regimen of     antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen     of antiretroviral drugs.   "
215072|NCT00665574|"     To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and     ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients     who have failed to respond adequately to conservative non-pharmacologic therapy and simple     analgesics   "
215060|NCT00665418|"     To describe laryngeal and respiratory reflex responses after controlled laryngeal stimulation     in pediatric patients anesthetized with sevoflurane and to compare the evoked responses at     two levels of anesthesia. To determine whether laryngeal and respiratory reflex responses     after controlled laryngeal stimulation are completely suppressed in subjects when     anesthetized with a MACEI95 (EI = endotracheal intubation) sevoflurane Hypothesis: The     incidence of apnea with laryngospasm evoked by laryngeal stimulation will be reduced by 20%     (from 25% to 5%) when the end-tidal concentration of sevoflurane is increased from 2.5%     (MAC50) to 4.7% (MACEI95)   "
215061|NCT00665431|"     We will evaluate the efficacy of PN 400 and an active comparator in patients that have     Osteoarthritis of the knee.   "
215062|NCT00665444|"     The proposed study is a non-randomized, open label trial that will examine the potential to     reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and     functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention     of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided     in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in     duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet     with their study psychiatrist at least bi-monthly throughout their participation, more     frequently when clinically necessary (e.g. during medication tapering or if manic/depressive     symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough     assessments will be conducted at Baseline, Week 2, and Month 3.   "
215063|NCT00665457|"     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This phase II clinical trial is studying biomarkers and side effects in women     receiving chemotherapy and celecoxib for stage II or stage III breast cancer that can be     removed by surgery.   "
215064|NCT00665470|"     Background:      This study uses a new experimental procedure for treating melanoma that uses the patient's     own lymphocytes (type of white blood cell), which are specially selected to target and     destroy their tumor.      Objectives:      To determine whether this experimental treatment can cause the patient's tumor to shrink.      To test the safety of the treatment and its effects on the immune system.      Eligibility:      Patients with metastatic melanoma 18 years of age and older for whom standard treatments are     not effective or who cannot take high-dose interleukin-2 (IL-2).      Patients must have the tissue type human leukocyte antigens (HLA-A)0201.      Design:      Workup: Patients have scans, x-rays, laboratory tests, and other tests as needed.      Patients have leukapheresis (a procedure for collecting lymphocytes that is similar to     collecting whole blood) to collect cells for laboratory treatment and later reinfusion.      Chemotherapy: Patients have low-dose chemotherapy for 1 week to prepare the immune system to     receive the cultured lymphocytes.      Cell infusion and IL-2 treatment: Patients receive the lymphocytes by infusion through a vein     and then either high-dose IL-2 infused through a vein or low-dose IL-2 injected under the     skin. High-dose IL-2 is given as infusions through a vein every 8 hours for up to 15 doses.     Low-dose IL-2 is given as injections under the skin daily for 5 days, followed by a 2-day     rest, with this regimen repeated for a total of 5 weeks.      Recovery: Patients rest for 1 to 2 weeks to recover from the effects of chemotherapy and     IL-2.      Tumor biopsy: Patients may be asked to have a biopsy (removal of a small piece of tumor)     after receiving treatment to look at the effects of treatment in the tumor.      Follow-up: After treatment is completed, patients return to the clinic for physical     examinations, review of side effects, laboratory tests and scans every 1 to 6 months until     the disease worsens.      Retreatment: Patients whose tumor did not grow after treatment or showed evidence of     shrinking may be able to be retreated if their tumor begins to grow. They receive the same     regimen of chemotherapy, lymphocyte infusion and IL-2 treatment....   "
215065|NCT00665483|"     Multicenter Skin Prick Test   "
215066|NCT00665496|"     This purpose of the study was to evaluate the earliest time to onset of action in adults with     erectile dysfunction (often called impotence). In this study vardenafil has been compared to     placebo. Patients were asked to fill in questionnaires and a diary in which they filled in     details about attempts at sexual activity during study period. Patients received also a     stopwatch to record the time of onset of erection. Stopwatch should be started immediately     prior to initiating sexual activity and stopped when an erection perceived to be adequate for     penetration was obtained.   "
215067|NCT00665509|"     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of     these vaccines are required to be involved in ongoing clinical trials and to present the     results to the competent authorities each year. The current study is a phase IIIa clinical     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It     is part of the ongoing clinical trial program for Influvac® and will be done to assess the     immunogenicity and safety and tolerability of next season's trivalent influenza subunit     vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects     >= 61 years of age (elderly).   "
215068|NCT00665522|"     The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine     conditions and obtain a more comprehensive understanding of the safety of the system and     complications that may not be spontaneously reported.   "
215069|NCT00665535|"     The purpose of the study is to determine the optimal frequency of repositioning nursing     facility residents with limited mobility who are cared for on a high density foam mattress in     order to prevent bed sores. It is hypothesized that participants at moderate risk (Braden     Scale Scores 13-14) who are turned every 3 or 4 hours and participants at high risk (Braden     Scores 10-12) turned every 3 or 4 hours will not have a higher incidence of ulcers than those     residents turned every 2 hours.   "
215070|NCT00665548|"     The purpose of the study is to use different x-ray and magnetic resonance (MR) imaging     techniques to take pictures of the knee. There are two specific purposes to the study:        1. whether the different x-ray and MRI techniques will give the same or different          information about the knee joint and        2. which part of the knee joint will show the biggest change using the different x-ray and          MRI techniques. The study is not designed to test a hypothesis.   "
215073|NCT00665587|"     Aim of the project is to assess the long-time clinical impact of surgical ablation (MAZE     procedure) on patients who suffer from atrial fibrillation but are indicated to a cardiac     surgery for other predominant cardiac diagnosis (heart valve surgery, coronary     revascularization or combined surgery). In recent years, those patients are more and more     frequently indicated to some type of MAZE procedure, without the real benefit of this     procedure for patients has been assessed with an enough large, randomized study. Even though     it is well known, that MAZE procedures declines the early postoperative incidence of atrial     fibrillation, convincing data about its mid-term and long-term impact on patients and about     the appearance of recidives of atrial fibrillation in long-time horizon are still missing.     Our hypothesis assumes, that MAZE procedure will significantly decrease the appearance of     atrial fibrillation one year after the operation, without increasing mortality or incidence     of serious postoperative complications in thirty postoperative days.   "
215078|NCT00665652|"     The purpose of the study is to learn about the effects of the drug, lenalidomide (Revlimid®),     on neuropathy (damage to the nerves that affect feelings and strength) associated with     Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS).   "
215079|NCT00665665|"     This trial will be conducted in the United States of America (USA). The aim of the trial is     to investigate whether the drug is safe, well tolerated and to investigate the efficacy of     NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and     placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase     1 part of trial conducted between November 2007 and April 2008).   "
215080|NCT00665678|"     Background: Innovation: Over 150,000 soldiers are currently deployed in Iraq as part of     Operation Iraqi Freedom (OIF), and 12% of returning OIF veterans have posttraumatic stress     disorder (PTSD). Research from our group and others showed lasting neurobiological     consequences of PTSD, including increased amygdala function and decreased medial prefrontal     function, verbal declarative memory problems, and smaller hippocampal volume that reverses     with treatment with the serotonin reuptake inhibitor (SSRI) paroxetine or the anticonvulsant     phenytoin. Recently we found that three months of treatment with paroxetine in PTSD patients     resulted in an increase in hippocampal N-acetyl-aspartate (NAA), a marker of neuronal     integrity, as well as decreased brain metabolism in the amygdala and a reversal or stress     induced decreases in medial prefrontal function. Subjects treated with placebo did not have     an increase in NAA, however subsequent treatment for three months with open label paroxetine     resulted in an increase in NAA to the level seen in the subjects treated with paroxetine in     the double-blind phase. Paroxetine was associated with a decrease in amygdala metabolism     measured with positron emission tomography (PET) and increased medial prefrontal function.     Intervening soon after the trauma is critical for long-term outcomes, since with time     traumatic memories become indelible and resistant to treatment. Diminished efficacy of     treatment over time is shown by the fact that trials of Vietnam veterans have shown less     efficacy over the years. Animal studies show that pretreatment before stress with     antidepressants reduces chronic behavioral deficits related to stress; although for ethical     and other reasons no studies have provided pretreatment before trauma exposure in humans. In     our current VA Merit funded program we are looking at the effects of early interventions for     Iraq soldiers with paroxetine, looking at chronicity of PTSD, cognition, cortisol response to     stress, hippocampal volume and NAA, as outcomes. We now propose to add measurement of neural     correlates of paroxetine response using PET.      Objectives/Hypotheses: The objectives of this research are to:        -  Assess the efficacy of paroxetine versus placebo in the treatment of early PTSD in OIF          veterans        -  Assess the effects of paroxetine versus placebo on amygdala metabolism and medial          prefrontal response to stress in OIF veterans with PTSD.        -  Assess the ability of brain imaging to predict treatment response and to identify          veterans with early PTSD who will benefit from early interventions.      Hypotheses are that paroxetine will be associated with: 1) an improvement in PTSD symptoms     compared to placebo based on the change in the CAPS from baseline to three months of     treatment in veterans of OIF; 2) increased medial prefrontal function and decreased amygdala     metabolism in veterans of OIF.      Specific Aims:        -  Compare paroxetine to placebo in the treatment of early PTSD in OIF veterans        -  Measure amygdala metabolism and medial prefrontal response to stress with PET in OIF          veterans with PTSD before and after paroxetine or placebo treatment.   "
215081|NCT00665691|"     Researchers are studying ways to predict if cancer patients are at risk for poor nutrition     during their chemotherapy treatment. They hope to identify children with nutrition problems     early in treatment. This may help prevent weight loss and other nutrition problems later in     treatment.   "
215082|NCT00665704|"     The purpose of this study is to develop an evidence-based Tobacco Tactics website tailored to     veterans based on an intervention tested in the VA.   "
215083|NCT00665717|"     The purpose of this trial is to determine the effect of raltegravir on pravastatin     pharmacokinetics and vice versa by intrasubject comparison.   "
215084|NCT00665730|"     This study will examine the safety and efficacy of Sepraspray in the following model of     abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via     laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be     evaluated laparoscopically at ileostomy take down. NOTE: A decision was made to terminate     this study in June 2008 due to low enrollment.   "
215085|NCT00665743|"     We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent     formulations.   "
215086|NCT00665756|"     In the management of open angle glaucoma, frequently more then one procedure is necessary to     control the intra ocular pressure. There is still no consensus whether this second     intervention should be a second trabeculectomy or a shunt device. In the present study we     compare a second trabeculectomy versus Ahmed silicone shunt device in open angle glaucoma     patients with previous trabeculectomy without proper IOP control.   "
215101|NCT00665951|"     This pilot pharmacokinetic study is designed to exclude a large difference (>40%) in     pharmacokinetics (esp. AUC) between two new Lopimune formulations and the branded     formulation. The formal bioequivalence study with adequate power will be conducted by the     manufacturer. In order to get data independently from the manufacturer and to have this     information in an earlier phase, this small pilot study is initiated.      The initial study showed a declined bioavailability of the granules under fasting conditions.     The study has been extended with an arm determining the pharmacokinetics of the granules     after food (compared to the oral solution taken with food).   "
215134|NCT00666380|"     The purpose of this study is to determine whether an investigational malaria vaccine is safe     and induces an immune response against malaria when tested in adults living in the United     States.   "
215135|NCT00666393|"     The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40     mcg system for the management of postoperative pain in pediatric inpatients.   "
215087|NCT00665769|"     Annually, almost 5,000 extremely low birth weight (9 ounces to about 2 lbs) infants born in     the US survive with severe bleeding in the brain (intraventricular hemorrhage); this     devastating complication of prematurity is associated with many problems, including mental     retardation, cerebral palsy, and learning disabilities, that result in profound individual     and familial consequences. In addition, lifetime care costs for these severely affected     infants born in a single year exceed $3 billion. The huge individual and societal costs     underscore the need for developing care strategies that may limit severe bleeding in the     brain of these tiny infants. The overall goal of our research is to evaluate disturbances of     brain blood flow in these tiny infants in order to predict which of them are at highest risk     and to develop better intensive care techniques that will limit severe brain injury.        1. Since most of these infants require ventilators (respirators) to survive, we will          investigate how 2 different methods of ventilation affect brain injury. We believe that          a new method of ventilation, allowing normal carbon dioxide levels, will normalize brain          blood flow and lead to less bleeding in the brain.        2. We will also examine how treatment for low blood pressure in these infants may be          associated with brain injury. We believe that most very premature infants with low blood          pressure actually do worse if they are treated. We think that by allowing the infants to          normalize blood pressure on their own will allow them to stabilize blood flow to the          brain leading to less intraventricular hemorrhage.        3. In 10 premature infants with severe brain bleeding, we have developed a simple technique          to identify intraventricular hemorrhage before it happens. Apparently, the heart rate of          infants who eventually develop severe intraventricular hemorrhage is less variable than          infants who do not develop this. We plan to test this method in a large group of          infants, to be able to predict which infants are at highest risk of developing          intraventricular hemorrhage and who could most benefit from interventions that would          reduce disturbances of brain blood flow.   "
215088|NCT00665782|"     RATIONALE: Gathering information about how patients respond to stress and measuring stress     levels in women with newly diagnosed breast cancer may help doctors provide better methods of     treatment and on-going care.      PURPOSE: This research study is measuring stress in women with newly diagnosed stage I, stage     II, or stage III breast cancer or ductal carcinoma in situ of the breast.   "
215151|NCT00666601|"     The purpose of this study is to measure the penetration of TR-700 into subcutaneous adipose     tissue and skeletal muscle after a single oral dose of 600 mg TR-701   "
215089|NCT00665795|"     The purpose of this protocol is to study orbital structures in Graves´ Disease using     multidetector computed tomography and color doppler imaging.      Some changes in orbital structures detected by imaging exams could predict severity of the     ocular Graves´disease. Thus the study could be useful in improve medical management of     patients with Graves´ Disease.   "
215090|NCT00665808|"     This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON     INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when     using Levemir® versus Protaphane® in combination with OADs in daily settings.   "
215091|NCT00665821|"     The purpose of this study is to assess the effect of two different types of health education     programs on the disability, beliefs related to low back pain and duration of sick leave in     patients seen at a workers' health care organization   "
215092|NCT00665834|"     This is a 3-month, randomized, parallel-group study with 2 periods, comparing the efficacy     and the safety of rosuvastatin 20 mg versus atorvastatin 80 mg in patients with an acute     coronary syndrome (ACS).   "
215093|NCT00665847|"     The purpose of this study is to determine the safety and antiviral activity of etravirine in     treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.   "
215094|NCT00665860|"     The purpose of this study is to determine whether soy isoflavone supplementation is safe and     effective to prevent bone loss in postmenopausal women.   "
215095|NCT00665873|"     BACKGROUND: The growing use of totally implantable venous access devices (TIVAD) has caused     the simultaneous increase of various complications. The infection of the TIVAD or the     subcutaneous pocket in which the device is positioned is one of the most encountered     complications. The aim of this study is to evaluate the role of the antibiotic in the     prevention of the infection of the surgical site and the TIVAD until 30 days after the     implant.      METHODS: The authors enrolled one hundred consecutive patients divided into two randomized     arms: group A (antibiotic), group B (no antibiotic), each of 50 patients. All the patients     were affected by solid tumors needing chemotherapy continuously. TIVADs were implanted     surgically in cephalic vein. Signs or symptoms considered were: pain, localized swelling,     redness, and heat. White cell count was considered on the first, third, and seventh     postoperative days, and the tests were made in the in-hospital laboratory. Body temperatures     were checked twice daily for 7 days.   "
215096|NCT00665886|"     The purpose of this study is to investigate, in a prospective and randomized fashion, the     clinical performance of a closed intravenous system versus an open conventional one, with     respect to ease of handling and effectiveness (as defined by time of survival without     complications), security provided to professionals and patients against accidental blood     exposure or needlestick injury, catheter-related complications such as phlebitis, pain and     blockage and overall costs of the two systems.   "
215097|NCT00665899|"     The purpose of the proposed study is to evaluate the efficacy of a new couple-based     intervention for women with recently diagnosed, early stage breast cancer and their spouses     or male partners. This cancer-focused relationship enhancement intervention adapts     well-validated cognitive-behavioral interventions to teach patients and partners specific     relationship skills, such as problem-solving skills, communication, and maximizing positive     interactions, that they can use in addressing breast cancer. This project's major goals are     to improve the patient's individual functioning and specific aspects of the couple's     relationship affected by breast cancer (e.g., mood, role functioning, sexual functioning, and     social support). In the current investigation, cancer-focused relationship enhancement will     be compared to (a) a couple-based Cancer Education intervention and (b) a Treatment-as-Usual     condition.   "
215098|NCT00665912|"     The purpose of this study is to determine whether the use of platelet-rich plasma (PRP) and     concentrated platelet-poor plasma (PPPc) can reduce the duration of post-operative air leak     after lobectomy for lung tumours.   "
215099|NCT00665925|"     The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor,     R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally,     once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an     inadequate clinical response to methotrexate.   "
215100|NCT00665938|"     The purpose of this study is to compare physical development of infants fed one of three     study formulas.   "
215136|NCT00666406|"     The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate     rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe     hemophilia A (factor VIII level < 1%).   "
215266|NCT00667927|"     This study proposes to transfer marker genes (detectable genetic traits or segments of DNA     that can be identified and tracked) into aliquots of marrow obtained for Bone Marrow     Transplant (BTM) in patients in remission of Acute Myelogenous Leukemia (AML).   "
215102|NCT00665964|"     Methodology: This study will be a randomized, multi-center evaluation comparing N2vac     polyethylene inserts and patellas with X3 inserts and patellas when used in the Triathlon PS     total knee system.      Study Duration: 12-18 month enrollment period + 10 year follow-up for each case years total     duration      Multi-centre study      Objectives      Primary: To compare the 10 year implant survival of the Triathlon PS total knee system when     X3 polyethylene components are used to the same knee system when N2Vac components are used.      Secondary: To compare pain, function, radiographic outcomes, and health related quality of     life of subjects in both treatment groups. Safety will be assessed by comparison of adverse     events between the groups.      Number of Subjects 384 cases (197 each group)   "
215103|NCT00665977|"     1. CPAP compliance will be significantly higher in both the heated humidity with          Thermosmart™ and the nasal steroid phases compared to the double placebo phase.        2. CPAP compliance will be comparably improved in the heated humidity with Thermosmart™          phase versus the nasal steroid phase.        3. Improvement in nasal symptoms in using CPAP will be significantly improved in both the          heated humidity with Thermosmart™ and the nasal steroid phases compared to the double          placebo phase, and comparable between the heated humidity with Thermosmart™ phase versus          the nasal steroid phase.        4. Secondary to improvements in CPAP compliance, measures of daytime functioning and          quality of life will improve in the heated humidity with Thermosmart™ versus double          placebo.   "
215104|NCT00665990|"     Phase I Study of Bevacizumab and Sorafenib Combined with Low Dose Cyclophosphamide in     Patients with Refractory Solid Tumors and Leukemia. Patients with solid tumors (including     central nervous tumors) that are recurrent or refractory to standard therapy, or for whom     standard therapy is not available. Once a maximum tolerated dose (MTD) has been established     in patients with recurrent or refractory solid tumors, the tolerability of this dose will be     tested in patients with refractory or recurrent leukemia and an expanded cohort of patients     with refractory or recurrent solid tumors.   "
215105|NCT00666003|"     Fluid and volume management are a challenging part of critical care and the difficulties     increase in the face of renal failure. Utilizing the Crit-Line to monitor blood volume     changes in conjunction with arterial pressure cardiac output monitoring may lead to better     understanding of the impact fluid removal during dialysis has on hemodynamics.   "
215106|NCT00666016|"     The purpose of this study is to assess the safety, the tolerability and the short term effect     on liver enzymes of TRO19622 500 mg for one month in patients with Non-Alcoholic     Steatohepatitis (NASH).   "
215107|NCT00666029|"     To characterize features of metabolic syndrome in volunteers. To undertake a randomised trial     to determine whether treatment with a statin improves muscle microvascular blood flow.   "
215108|NCT00666042|"     The study compares the amounts of Vigamox absorbed when administered as eye drops or in a     spray form. Both administrations will be prior to patients undergoing elective cataract     surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. The     hypothesis is that there will be no difference between the 2 modes of administration.   "
215109|NCT00666055|"     The purpose of this research study is to learn about levels of antiretroviral drug levels and     response to HIV virus in the genital tract of women who are post-menopausal. The     investigators in this study think that the levels of hormones post-menopausal HIV-infected     women may have in their bodies may affect the levels of antiretroviral drug, and therefore     affect how much HIV virus they have in their bodies. Since women who have already gone     through menopause have different levels of hormones, such as estrogen, than women who are     pre-menopausal, the investigators would like to check the levels of antiretroviral drugs in     their blood, their genital secretions, and their genital tissue.   "
215110|NCT00666068|"     In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine     responses when hormones are injected. This is at least true for those with a complete     insufficiency of the anterior pituitary. For example, administration of corticotropin     releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore,     pure hormone effects can be investigated.      It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved     in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was     reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was     therefore to study the effect of CRH on patients with hypopituitarism.      To date, there is no information on sleep of patients with hypopituitarism. Secondary     objective is therefore to compare sleep of patients with hypopituitarism with sleep of     age-matched healthy controls.   "
215111|NCT00666081|"     This is a two-part study in subjects with hematologic malignancies designed to find the     maximum tolerated dose (MTD) of GSK690693 (Part 1). Part 2 is designed to determine the     efficacy of GSK690693 in a subset of subjects with hematologic malignancies.   "
215112|NCT00666094|"     To test the hypothesis that there is no difference in change in HbA1C among men with type     2-diabetes after an exercise intervention with strength versus endurance training.   "
215113|NCT00666107|"     This study will investigate the efficacy and safety of the quadrivalent vaccine (Gardasil)     against the human papilloma virus (HPV) in HIV (human immunodeficiency virus) infected males.   "
215114|NCT00666120|"     To compare the number of infants who discontinue from study formula due to formula     intolerance as documented by the investigator.      Hypothesize there will be no difference between formula groups.   "
215129|NCT00666315|"     New haemostatic techniques have been developed with the advent of laparoscopic surgery. Among     other things, ultrasound instruments have been used for the dissection, division and     coagulation of vessels and other tissue. Previous studies in Thyroidectomy observed a     clinically and economically significant reduction in operating time with no increase in the     complication rate when the Harmonic device has been used. The aim of the present clinical     trial is to evaluate potential advantages of a new Harmonic device (FOCUS), developed     especially for Thyroid procedures, in the use of HS in thyroidectomies when compared with EC     in terms of operative time, number of ligatures, QoL, blood loss, pain intensity at the     surgical site, amount of drainage, and complications, including the incidence of RLN palsy     and hypoparathyroidism.   "
215130|NCT00666328|"     The purpose of this study was to determine the efficacy and safety of clevidipine for     treating acute hypertension (high blood pressure, defined as systolic blood pressure >160     mmHg) in patients with intracerebral hemorrhage (i.e., bleeding in the brain; stroke).   "
215115|NCT00666133|"     Preeclampsia is a condition unique to pregnancy characterized by the new onset of     hypertension and proteinuria. Eclampsia, characterized by maternal seizures, is a serious     complication increasing the risk of maternal and infant mortality and morbidity. Magnesium     sulfate is the drug of choice for prevention and treating convulsions in severe preeclampsia     and eclampsia.      Magnesium sulfate is administered parenterally by intramuscular (IM) or intravenous routes     (IV). In general a loading dose of 4 to 5 grams of magnesium sulfate is administered     intravenously followed by an IM injection every 4 hours or by a continuous IV infusion. The     IV regimen achieves more stable serum levels of magnesium but requires the use of an infusion     pump for safe delivery and has a greater potential for inadvertent overdose. Although     magnesium sulfate has been demonstrated as a safe and effective drug for the treatment and     prevention of severe preeclampsia and eclampsia, concerns about the safety of the drug     remain. The IM dosing regimen, while potentially safer, requires repeated painful IM     injections. These limitations in administration hinder the widespread use of magnesium     sulfate despite its demonstrated benefits.      The goal of this research is to develop a system of care that avoids overdose and facilitates     the use of magnesium sulfate for the treatment of preeclampsia. To this end, a primary     objective of this research is to demonstrate the safety of a simple, inexpensive flow     controlled pump system (Springfusor®). This randomized study will compare the administration     of magnesium sulfate by the Springfusor® controlled pump with an IM regimen, the standard of     care in most hospitals in India. The study will document the efficacy and acceptability of     each treatment for patients and staff and compare the cost and time elements involved in     providing each method.   "
215152|NCT00666614|"     The purpose of this pilot study is to determine if patients randomized to a hospital sleep     environment intervention would have improved sleep quality and reduced fatigue as compared to     the patients not receiving the intervention (standard care).   "
215116|NCT00666146|"     We propose to recruit 150 case families (i.e., families with a schizophrenia proband), 150     control families, and 45 control subjects who exhibit schizophrenia spectrum personality     symptoms in the absence of a family history of schizophrenia. Participants will undergo a     number of clinical, electrophysiological, perceptual, and cognitive assessments. These data     will be used to identify phenotypes likely to be associated with genetic risk for     schizophrenia, and to determine how these phenotypes aggregate in families. Some of the     analyses will focus on examining associations between candidate genes and these alternative     phenotypes. Thus if we are not able to recruit relatives we may still collect these     phenotypic data in probands and their genetic sample for future genotype/phenotype     association studies. Testing procedures require a 10-12 hour time commitment and testing will     be completed over 2 or more days. Participants will be asked to give a blood (or saliva if     difficult to obtain blood sample for instance because of fear of blood draws), which will be     stored for future genetic analyses.   "
215117|NCT00666159|"     Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in     pediatric patients with Atopic Dermatitis   "
215118|NCT00666172|"     Employees in developed societies are becoming increasingly sedentary at work and at home due     to technological advances. Physical inactivity coupled with excess intake of calorie-rich     foods are responsible for the epidemic of obesity. In population cohorts, physical inactivity     and obesity increase the risk of cardiovascular disease and death. Because of the impact on     productivity and health care costs, many businesses and other organizations have initiated     wellness programs, often with facilities at the work site to encourage exercise. Although     these programs have often resulted in improved fitness for participants, weight loss has been     more difficult to achieve. In this regard, in our initial study of NIH employees     participating in NHLBI's Keep the Beat program--two-thirds of whom were overweight or     obese--we found improved exercise fitness after 3 months of participation, with exercise     averaging 20 minutes each work day, but no significant weight loss. Associated with greater     fitness in our participants was improvement in endothelial function, an important biomarker     of cardiovascular risk. Because level of fitness is a strong predictor of cardiovascular (and     total) mortality in population studies, some investigators and thought leaders have proposed     that it is acceptable to be fat and fit. We found in our study, however, that exercise     alone has little effect on insulin sensitivity and other biomarkers of risk, including     C-reactive protein, which could limit further improvement in endothelial function and even     greater risk reduction. We propose to test in this protocol whether weight loss through     supervised nutritional counseling and daily exercise at worksite facilities confers health     benefits beyond those achieved with improved fitness alone, such as improvement in     endothelial function, arterial compliance, insulin sensitivity, markers of inflammation in     blood and high-density lipoprotein (HDL) structure and function. Because obesity in a     sedentary workforce environment is especially prevalent among women, with additional     contribution of menopause to obesity, our study will be restricted to overweight and obese     women to allow appropriate analysis in a cohort of manageable size for our testing resources.     The primary endpoint will be differential improvement in endothelial function, as determined     by brachial artery reactivity to shear stress, from baseline to 6 months in participants     randomized to exercise coupled with weight-loss intervention versus subjects randomized to     exercise alone. Secondary analyses will include comparisons of adiposity, arterial stiffness,     insulin sensitivity, HDL subparticles and function, and markers of inflammation and     adipokines in blood, with exploratory analyses of minorities and age/hormonal interactions.     Demonstration of improved vascular function and other biomarkers of cardiovascular risk with     improved fitness combined with weight loss may serve as an incentive for greater     participation in organization-initiated wellness programs with emphasis both on exercise and     on personalized nutritional counseling.   "
215119|NCT00666185|"     To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment     of patients with Esophageal Candidiasis   "
215120|NCT00666198|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
215121|NCT00666211|"     RATIONALE: An Opioid Titration Order Sheet that allows healthcare providers to adjust the     dose and schedule of pain medication may help improve pain treatment for patients with     cancer. It is not yet known whether the use of an Opioid Titration Order Sheet is more     effective than standard care in treating pain caused by cancer.      PURPOSE: This randomized phase III trial is studying an Opioid Titration Order Sheet to see     how well it works compared with standard care in treating patients with cancer pain.   "
215122|NCT00666224|"     The primary objective is to assess the effect of treatment with glatiramer acetate (GA)     compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the     occurrence of the second clinical attack) during the double-blind period. The secondary     objective is to assess, within the time frame of the up to 3-year double-blind,     placebo-controlled study period, the effect of GA on clinical and Magnetic Resonance Imaging     (MRI) parameters. The long-term objectives of the study (exploratory in nature) are to     assess, within the time frame of 5 years, the neuroprotective effect of early versus delayed     treatment with GA as reflected by clinical and MRI parameters measuring the accumulated     irreversible brain tissue damage.      A pre-planned interim analysis was performed on all efficacy and safety data accumulated in     the database up to October 14, 2007, i.e. when 81% of exposure to treatment in the     double-blind, placebo-controlled period had been collected. Upon review of the interim     analysis results, the Data Monitoring Committee (DMC) recommended that the double-blind     portion of the study be stopped and that subjects be switched to the 2-year Open-label     period, during which time they would have the option of receiving GA therapy. The sponsor     (Teva) adopted the DMC recommendations and took the necessary action towards its     implementation.   "
215123|NCT00666237|"     The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the     long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with     mitomycin C in eyes that have not had previous ocular surgery.   "
215124|NCT00666250|"     An antioxidant dietary supplement made from cocoa powder, and extracts of acai, grape and     blueberry will be tested for effects on blood sugar, blood pressure, cholesterol and related     parameters in human subjects.   "
215125|NCT00666263|"     The purpose of the study is to evaluate the efficacy (effect on grip strength and disability)     and safety/tolerability of IGIV, 10% in subjects with Multifocal Motor Neuropathy.   "
215126|NCT00666276|"     Drug use investigation of Zyvox for patients with Methicillin-resistant Staphylococcus aureus     (MRSA) infection disease.      The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of     adverse drug reactions in this surveillance, and 3)factors considered to affect the safety     and/or efficacy of this drug.   "
215127|NCT00666289|"     Myeloproliferative disorders occur in families, thus giving rise to the theory that it is a     genetic disease that may be caused by an abnormal gene in the DNA that can be passed from one     generation of family members to another. DNA can be gathered from family members through     blood samples and the investigators will investigate (through DNA testing) to see if there     are abnormal genes that may be responsible for causing the MPDs. Understanding which genes     are responsible for causing MPDs can help develop ways to identify people who may be at risk     for developing an MPD, allow for the development of better treatments, possibly a cure, or     even prevent the development of MPDs.   "
215128|NCT00666302|"     A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients     with Atopic Dermatitis   "
215131|NCT00666341|"     Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen     (Phleum pratense)   "
215137|NCT00666419|"     A large study in Mallorca, Spain showed that nonspecific low back pain is quite prevalent in     adolescents 13-15 years of age (Kovacs, 2003). Since below the age of seven years hardly any     child has suffered low back pain, the purpose of this study is to determine the prevalence of     low back pain in children 10-12 years of age, and to investigate the risk factors associated     with its occurrence.   "
215138|NCT00666432|"     Briefly, this multisite study is designed to identify endophenotypes (i.e., heritable     biomarkers) associated with either schizophrenia or bipolar disorder alone, or both together.     The subsequent genetic analyses will search genomic loci and candidate genes associated with     each of the independent endophenotypes. This is a five site study that is slotted for NIMH     funding.   "
215200|NCT00660686|"     The purpose of this study is to conduct a 12-month randomized controlled trial comparing the     effects of strength and impact exercise training to flexibility/relaxation training on body     composition (bone, muscle and fat mass), physical function (strength, gait, power, balance     and self-report physical function and symptoms) in men currently treated with hormone therapy     for prostate cancer.   "
215139|NCT00666445|"     This study is designed to test the hypothesis that the Synchronous Neural Interaction™ Test     is useful for diagnosing Probable Alzheimer's Disease according to standard criteria.     Subjects diagnosed with Alzheimer's Disease as well as age-matched normal control subjects     will be evaluated for symptoms of Alzheimer's Disease and those meeting inclusion criteria     will undergo a brief, non-invasive scan of brain function using a magnetoencephalography     (MEG). The scan itself lasts 1 minute while the subject is asked to stare at a dot projected     in front of them on a video screen. Orasi Medical believes that patterns of brain activity     measured at rest are indicative of Alzheimer's Disease pathology.      The protocol is amended to add a follow-up assessment for previously enrolled and completed     subjects who agree to participate in the follow-up assessment approximately 9 - 15 months     after initial study enrollment. Subjects who agree to participate in the follow-up assessment     will undergo the same standardized tests and MEG scan procedure as completed in the initial     study.   "
215140|NCT00666458|"     Saxagliptin is a new investigational medication being developed for treatment of type 2     diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in     addition to metformin and compare to sitagliptin in addition with metformin.   "
215141|NCT00666471|"     Epistaxis is a common disorder with 60% of the population suffering from one episode and 10%     of these cases requiring medical attention. Between March 2006 and March 2007, in Calgary,     Alberta, there were 1500 presentations of epistaxis to adult emergency rooms with 7% of these     (105 patients) requiring packing with admission. Common methods to control epistaxis include,     nasal packing (88%), operative arterial ligation (10%), and arterial embolization (2%). A     cost analysis demonstrated that nasal packing had a lower cost compared to embolization and     arterial ligation, and all modalities had similar lengths of stay (Goddard, Otolaryng Head     Neck Surg. 2006). Arterial ligation is the current recommended therapy for recurrent or     refractory epistaxis, with a success rate of 98%. With the advancement of endoscopic     techniques, emergency room Minimally Invasive Control of Epistaxis (M.I.C.E.) allows for     selective packing and cauterization, which provides the patient with retained function of     their nasal cavity and prevents a hospital admission, resulting in significant cost savings.      Hypothesis:      Does the M.I.C.E. procedure provide significant cost savings compared to operative     sphenopalatine artery ligation? Null hypothesis is that there is no difference in hospital     admission rates between M.I.C.E. and operative sphenopalatine artery ligation.   "
215142|NCT00666484|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. It is not yet known     which regimen of combination chemotherapy is more effective for Hodgkin lymphoma.      PURPOSE: This phase II trial is studying the side effects of three different regimens of     combination chemotherapy and to see how well they work in treating younger patients with     Hodgkin lymphoma.   "
215143|NCT00666497|"     The purpose of the study is to determine how effective azacitidine, MGCD0103, and the     combination of azacitidine and MGCD0103 are in treating AML or MDS in people over 60 years of     age.   "
215144|NCT00666510|"     Intraoperative bronchospasm challenges anesthesia's safety. This study aims to investigate     high concentration of exhaled nitric oxide as a marker of intraoperative bronchospasm.   "
215145|NCT00666523|"     The objective of the study is to test the effects of a herbal supplement, Phytalgic, on the     symptoms of osteoarthritis of the knee or hip, in patients with OA using NSAIDs or analgesics     on a regular basis.   "
215146|NCT00666536|"     The purpose of this trial is to compare blood pressure lowering efficacy of moderate     Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 /     10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan   "
215147|NCT00666549|"     This study that will allow for the preservation and/or storage of a small portion one or more     of the following tissues:        -  Peripheral blood        -  Bone marrow        -  Bone marrow biopsy        -  A phlebotomized unit of blood        -  Spleen cells        -  Toenail clippings      This material will be used for the study of Myeloproliferative Disorders (MPD) by     researchers. The goals of this research study are to understand the causes of MPDs, how to     diagnose them more easily and how to treat them better. MPD is a disease affecting     hematopoietic stem cells. Hematopoietic stem cells are cells that make blood cells. These     stem cells grow in the center portion of the bones called bone marrow. Under some conditions,     these cells are also found in blood. There are several diseases, which are classified as MPD.     These include polycythemia vera (too many red blood cells), essential thrombocythemia (too     many platelets), and idiopathic myelofibrosis (abnormal blood cells and fibers build up in     the bone marrow). These syndromes carry a high risk of developing leukemia. It is important     to continue to learn more about these blood cancers and to learn more about the effectiveness     and potential side effects of various treatments.   "
215148|NCT00666562|"     Green tea extract contains ingredients that may slow the growth of certain cancers. It is not     yet known whether green tea extract is more effective than a placebo when given before     surgery in treating patients with bladder. This randomized phase II trial is studying green     tea extract to see how well it works compared to a placebo when given before surgery in     treating patients with nonmetastatic bladder cancer.   "
215149|NCT00666575|"     The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a     potential over-the-counter population with reports of occasional sleeplessness   "
215170|NCT00666848|"     This study will measure the effect of the anti-diabetic agent sitagliptin on blood pressure     in individuals with the metabolic syndrome. We will also measure the effect of sitagliptin on     blood pressure in people already taking a blood pressure medication called an ACE inhibitor.   "
215150|NCT00666588|"     This phase II trial is studying the side effects and best dose of bortezomib and to see how     well it works when given together with combination chemotherapy in treating younger patients     with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop     the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used     in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) together with bortezomib may     kill more cancer cells   "
215153|NCT00666627|"     A study to determine if the three licensed bisphosphonates (alendronate, ibandronate and     risedronate):a) affect the peripheral skeleton differently, as assessed by quantitative     ultrasound of bone (QUS), peripheral quantitative computed tomography (pQCT) and dual−energy     x−ray absorptiometry (DXA)? b) have different effects on bone cells and their activity as     assessed by flow cytometry and biochemical markers of bone cell activity? The aim of the     study is to compare the effects of three licensed bisphosphonates on bone quantity and     quality. There has been no such study before. Most of the measures of bone quantity and     quality used in this protocol have not been studied with any of these three agents. The     novelty of the study necessitates the establishment of reference ranges and this explains the     need for the inclusion of a group of young women.   "
215154|NCT00666640|"     The study aims to determine the efficacy and best methods for predicting hip fractures and     diagnosing post-menopausal osteoporosis using three dimensional structural engineering models     (SEMs) of proximal femoral bone produced using a Hologic Discovery duel-energy x-ray     absorptiometry scanner and Hologic's new 3D Hip(TM) software in comparison to three     dimensional SEMs produced using quantitative computed tomography - the current gold standard.   "
215155|NCT00666653|"     The purpose of this study is to determine whether there is a benefit to giving a dopamine     agonist to a patient with Parkinson's disease who is already being treated with levodopa.   "
215156|NCT00666666|"     This phase II trial is studying how well giving gossypol together with androgen ablation     therapy works in treating patients with newly diagnosed metastatic prostate cancer. Gossypol     may stop the growth of tumor cells by blocking blood flow to the tumor. Androgens can cause     the growth of prostate tumor cells. Luteinizing hormone-releasing hormone agonists and drugs,     such as bicalutamide, may lessen the amount of androgens made by the body. Giving gossypol     together with androgen ablation therapy may be an effective treatment for prostate cancer   "
215157|NCT00666679|"     This study assesses inhaled corticosteroid plus montelukast compared with inhaled     corticosteroid therapy alone for treatment of patients with chronic asthma.   "
215158|NCT00666692|"     The primary purpose of this study is to examine the safety of volociximab (V) in combination     with a standard treatment of carboplatin (C), paclitaxel (P), and bevacizumab (B) in subjects     previously untreated with chemotherapy for advanced stage (IIIB/IV) non-squamous non-small     cell lung cancer (NSCLC).   "
215159|NCT00666705|"     An open label study to evaluate an interaction between maraviroc and raltegravir in healthy     subjects.   "
215160|NCT00666718|"     This study is designed to look at if a basal bolus regimen of insulin lispro protamine     suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin     glargine (when one basal bolus regimen is injected once daily together with insulin lispro     injected 2-3 times daily).   "
215161|NCT00666731|"     RATIONALE: Gathering information about patients with breast cancer and their families may     help the study of breast cancer in the future.      PURPOSE: This clinical trial is gathering information about patients with breast cancer and     their families.   "
215162|NCT00666744|"     The aim of the study is to evaluate the functional recovery in two groups of primary stroke     patients presenting with moderate/severe disability over a six month period through the     implementation of a randomised controlled trial. The first group or the experimental group     will receive routine therapy and additional lower limb exercise therapy in the form of family     assisted exercises. The second group or the control group will receive routine therapy with     no additional formal input from their family members. A secondary aim of the project is to     evaluate the impact of the FAME programme on the person with stroke and the individual (s)     assisting in the delivery of exercises.   "
215163|NCT00666757|"     The purpose of this study is to compare duloxetine with other antidepressants in the     treatment of severe depression.   "
215164|NCT00666770|"     The purpose of this study is to assess the effect of gabapentin as compared to placebo on     sleep in subjects with transient insomnia.   "
215165|NCT00666783|"     This clinical study was designed to demonstrate that a single, intravenous dose of     palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed     CINV and was also well tolerated in the Chinese cancer patients.   "
215166|NCT00666796|"     The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and     ethanol   "
215167|NCT00666809|"     There is incidental evidence (casuistic findings) that the treatment with vardenafil of male     patients suffering from erectile dysfunction and comorbid tinnitus experienced an improvement     of their tinnitus.      Randomized, parallel-group, double-blind, placebo-controlled trial over 16 weeks (12 weeks of     treatment + 4 weeks follow-up) with 10 mg vardenafil BID p.o. in men and women with chronic     tinnitus.   "
215168|NCT00666822|"     RATIONALE: Understanding how well patients comply with their treatment regimen may help     doctors plan the best treatment and ongoing care.      PURPOSE: This clinical trial is studying whether patients comply with their hormone therapy     regimen in women with estrogen receptor-positive stage I, stage II, or stage IIIA breast     cancer.   "
215169|NCT00666835|"     This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving     about 462 clinically stable hemodialysis patients aged 18 years or above suffering from     anemia and treated previously with a stable dose of ERYPO® intravenously.   "
215171|NCT00666861|"     A randomised, cross-over trial targeting a small sample of older (age 45-65 years) overweight     adults with type 2 diabetes the aims of this pilot study are to:        1. Determine the feasibility of investigating the acute effects of prolonged sedentary          behaviour (sitting) in this target group.        2. Compare the acute effects of a single prolonged (8 hour) bout of sedentary behaviour          (sitting) on glucose and triglyceride concentrations and key muscle and adipose          regulatory enzymes to a similar bout of sedentary behaviour combined with intermittent          bouts of light-intensity activity.   "
215201|NCT00660699|"     To assess the feasibility of administering induction chemotherapy with gemcitabine and     docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation     gemcitabine/docetaxel chemotherapy.   "
215202|NCT00660712|"     A registry study to identify the patient-diagnosis-treatment characteristic profile of     patients with bipolar disorder in Turkey.   "
215172|NCT00666874|"     Obesity is an independent risk factor for cardiovascular disease, which may be mediated by     increased secretion of proinflammatory cytokines by adipose tissue.      To determine the effect of a program of changes in lifestyle designed to obtain a sustained     reduction of body weight on markers of systemic vascular inflammation and insulin resistance.      Randomized single-blind trial conducted from February 1999 to February 2002 at a university     hospital in Italy.      One hundred twenty premenopausal obese women (body mass index 30) aged 20 to 46 years without     diabetes, hypertension, or hyperlipidemia.      The 60 women randomly assigned to the intervention group received detailed advice about how     to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet     and increased physical activity. The control group (n = 60) was given general information     about healthy food choices and exercise.   "
215173|NCT00666887|"     The aim of the trial is to demonstrate that 100 mg of oral minocycline twice daily reduces     the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to     placebo, over a 6 month follow-up period (primary outcome).      A key secondary outcome is to confirm that this early treatment benefit is maintained at two     years.   "
215174|NCT00666900|"     The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating     patients with acne vulgaris.   "
215175|NCT00666913|"     RATIONALE: Gathering information about the frequency and intensity of hot flashes in patients     with breast cancer and in patients who have a high risk of developing breast cancer may help     doctors learn more about menopausal symptoms.      PURPOSE: This clinical trial is looking at menopausal symptoms in women with breast cancer or     at high risk of breast cancer who received treatment on another clinical trial.   "
215176|NCT00666926|"     Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase     (FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography [PET]     scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and     prostatic neoplasms, and patients with other malignancies appropriate for serial biopsy.     Screening consists of a Fluorodeoxyglucose Positron Emission Tomography [FDG-PET] and tumor     imaging, medical history, physical examination, Eastern Cooperative Oncology Group [ECOG]     performance status, blood draws, a pregnancy test for female patients of childbearing     potential. Treatment consists of PF00562271 tablets continued until progression of disease,     unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial     FDG-PET and blood tests for biomarkers related to FAK and PYK2 kinase activities.   "
215177|NCT00666939|"     The purpose of this study is to assess the effect of gabapentin as compared to placebo on     sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a     sleep phase advance.   "
215178|NCT00666952|"     Morbid obesity currently affects more than 11 million US adults and is strongly associated     with type 2 diabetes, cancer, cardiovascular disease, and arthritis. Bariatric (weight loss)     surgical procedures have been shown to significantly reduce body weight and improve the     health and quality of life of morbidly obese adults, at least in the short term. However,     bariatric surgery also presents substantial risks, including a 10% to 20% risk of serious     complications and up to a 2% risk of death in the first 30 days after surgery. Thus, a     morbidly obese patient's decision regarding bariatric surgery should be based on his or her     evaluation of accurate information on the possible risks and benefits of the various     treatment options. Anecdotal reports suggest that bariatric treatment decisions may be more     heavily influenced by insurance coverage and reimbursement rates than patient preferences.      The main objective of the current proposal is to examine the impact of a bariatric decision     aid, Weight loss surgery: Is it right for you?, on decision quality in primary care and     bariatric specialty practice settings. We propose a randomized controlled trial to assess the     effect of this bariatric decision aid on bariatric-specific measures of patient knowledge,     values and choice of weight management strategy. We will also investigate the effect of the     decision aid on decisional conflict and decisional self-efficacy and examine medical,     psychological, and behavioral factors as mediators and moderators of treatment choice. This     information will help to elucidate the value of this decision aid in improving decision     quality.      The primary aims of this of this research are to:        1. Determine if the bariatric decision aid results in superior bariatric surgery decision          quality than an NIH booklet on weight loss surgery ('usual care').        2. Determine if the bariatric decision aid results in less decisional conflict and superior          decisional self-efficacy than usual care.        3. Determine if there is a differential effect of the interventions on decision quality          among treatment seekers and non-treatment seekers.        4. Investigate medical, psychological, and behavioral factors as mediators of treatment          choice.      The secondary aims of this study are to:        1. Understand the current weight control attitudes and practices among morbidly obese          patients who are not actively seeking bariatric surgical treatment.        2. Assess the rates of bariatric surgery, health care costs, health care use and outcomes,          and changes in BMI over time across the intervention groups, as well as across study          subgroups, such as those who did and did not choose to have bariatric surgery.      We hypothesize that the decision aid will result in greater knowledge and greater values     concordance, less decisional conflict and superior decisional self-efficacy than the NIH     booklet.   "
215179|NCT00666965|"     The primary objective of this study is to investigate efficacy and safety of SPM 962 in     Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group     comparative study following once-daily multiple transdermal doses of SPM 962 within a range     of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.   "
215180|NCT00666978|"     RATIONALE: A stop-smoking plan that includes health education counseling and bupropion may     help African-American smokers stop smoking. It is not yet known whether health education     counseling is more effective with or without bupropion in helping African Americans stop     smoking.      PURPOSE: This clinical trial is studying health education counseling and bupropion to see how     well they work compared with a placebo and health education counseling in helping African     Americans smokers stop smoking.   "
215181|NCT00666991|"     The purpose of this study is to evaluate the safety, pharmacokinetics and preliminary     efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in     patients with refractory malignancies principally confined to the peritoneal cavity.   "
215182|NCT00667004|"     Efficacy study of ecabet ophthalmic solution in dry eye disease   "
215183|NCT00667017|"     RATIONALE: Immunotoxins, such as RFT5-dgA immunotoxin (also called anti-CD25 immunotoxin     IMTOX25), can find certain cancer cells and kill them without harming normal cells.      PURPOSE: This phase II trial is studying the side effects of anti-CD25 immunotoxin IMTOX25     and how well it works in treating patients with relapsed or refractory cutaneous T-cell     non-Hodgkin lymphoma.   "
216247|NCT00674479|"     The goal of this clinical research study is to learn if ruxolitinib can help to control     advanced hematological malignancies. The safety of this drug will also be studied.   "
215203|NCT00660725|"     This is a research study that will try to find the highest and safest dose of an experimental     drug, vandetanib, that can be given in combination with two standard chemotherapy agents,     gemcitabine and oxaliplatin, to subjects with advanced solid malignancies.   "
215281|NCT00668122|"     To assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR)     tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet     500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial     urinary tract infections (cUTI).   "
215184|NCT00667030|"     Over half of adults in this country are overweight. This increases risk for heart and blood     pressure problems, cancer, stroke and arthritis. While it is difficult to lose large amounts     of weight and keep it off, even small amounts of weight loss can improve health. Furthermore,     fat is increasingly recognized as a source of substances that increase inflammation. It may     be that some of the adverse consequences of being overweight are due to increased     inflammation. We are asking you to volunteer for a research study in which you may lose a     moderate amount of weight and increase your activity. It is important that you read and     understand the information on this form.      The purposes of these studies are to determine the influence(s) of age and body composition     on the production of inflammatory chemicals by fat (adipose tissue), the mechanisms     controlling this, and if a weight loss and aerobic exercise intervention results in a     decrease in inflammation.   "
215185|NCT00667043|"     The aim of this study is to increase knowledge about drug properties and effects during     therapeutic hypothermia. The primary end point of this study is the time from termination of     sedation to extubation in patients treated with therapeutic hypothermia, after treatment with     the combination remifentanil and propofol versus that of fentanyl and midazolam.   "
215186|NCT00667056|"     A study of subjects with a known nickel allergy comparing Tacrolimus to placebo, both     associated with nickel patches to determine the safety and efficacy of treating Chronic     Allergic Contact Dermatitis with Tacrolimus Ointment   "
215187|NCT00667069|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such     as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses     high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and     radiation therapy soon after surgery or later after surgery is more effective in treating     prostate cancer.      PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy     soon after surgery to see how well it works compared with giving them later after surgery in     treating patients who have undergone surgery for intermediate-risk stage III or stage IV     prostate cancer.   "
215188|NCT00667082|"     This is a clinical trial examining the safety, pharmacokinetics, pharmacodynamics and     efficacy of IV NPI-0052 (a proteasome inhibitor) in combination with oral vorinostat     (Zolinza; a HDAC inhibitor) in patients with non-small cell lung cancer, pancreatic cancer,     melanoma or lymphoma. Proteasome inhibitors block the breakdown of proteins by cells and HDAC     inhibitors block modification of proteins regulating gene expression in cells. Both of these     actions preferentially affect cancer cells, and the combination of the two has been seen to     have a greater effect in laboratory studies.   "
215189|NCT00667095|"     The purpose of this study is to determine whether women with overactive bladder (OAB) who     receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl     Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms     when compared to a similar group of women with OAB who receive instillation of DMSO only.   "
215190|NCT00667108|"     The purpose of this study is to assess the effect of gabapentin as compared to placebo on     sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a     sleep phase advance.   "
215191|NCT00667121|"     RATIONALE: Studying samples of blood in the laboratory from patients receiving tamoxifen may     help doctors learn more about the effects of other drugs on the level of tamoxifen in the     blood.      PURPOSE: This clinical trial is studying levels of tamoxifen in the blood of women with     breast cancer and in women at high risk of breast cancer who are receiving tamoxifen together     with venlafaxine, citalopram, escitalopram, gabapentin, or sertraline.   "
215192|NCT00667134|"     This study is to determine if subjects with .systemic sclerosis have stimulatory     autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF     receptor in skin sites with varying degrees of skin thickening   "
215193|NCT00667147|"     This study uses the drugs Abraxane (also called ABI-007) and Vandetanib (also called Zactima     and ZD6474). Abraxane has been approved by the Food and Drug Administration (FDA), for the     treatment of breast cancer. Vandetanib is an experimental drug and has not been approved by     the FDA for the treatment of any condition. Vandetanib has shrunk some non-small cell lung     cancer, prostate cancer and thyroid cancer in some studies in humans. This combination of     drugs is not approved for the treatment of any condition by the FDA.      This study is being done in two phases. The first phase of the trial has two main objectives:     1) To find the highest daily dose of vandetanib that can be given safely with once weekly     Abraxane and 2) To find the highest daily dose of vandetanib that can be given safely with     Abraxane given every three weeks. Participants will be randomly assigned (like flipping a     coin) to receive Abraxane weekly (Arm A) or once every three weeks (Arm B). The dose of     Abraxane given will remain the same for the whole study - 100 mg/m2 when given weekly and 260     mg/m2 when given every three weeks. Participants will be entered onto each arm of the study     in groups of three, and higher doses of vandetanib will be given each group of participants.     The increase of vandetanib will stop once more than one participant has serious side effects.     The highest dose of vandetanib that can be given with Abraxane (without serious side effects)     in each Arm will be called the pilot dose.      In the second phase of the study twenty participants will be randomly assigned to Arm A or     Arm B and receive the pilot dose of vandetanib that was reached in the first phase of the     study. The purpose of the second phase of the study is to see how many tumors shrink when     participants receive the pilot dose of the drug combination on each Arm, as well as to gather     more information about the side effects.   "
215194|NCT00660608|"     Fifty patients will be enrolled into the study. The purpose of the study is to investigate     the relevance of Hct levels in determining need for transfusion during operations employing     bypass as well as to test the hypothesis that, while HCt levels may decrease during surgery ,     red blood cell mass and tissue oxygenation remain fairly constant.   "
215195|NCT00660621|"     To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer     implantation, followed by concomitant limited field radiation therapy and temozolomide,     followed by dose dense temozolomide and bevacizumab in subjects undergoing initial surgery     for newly-diagnosed high grade glioma.   "
215196|NCT00660634|"     To investigate whether endovascular revascualrization of infrainguinal arterial obstructive     disease has an effect on brachial artery reactivity   "
215197|NCT00660647|"     Optimized treatment algorithm in early rheumatoid arthritis:      Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the     treatment of early rheumatoid arthritis.      A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the     additive effect of adalimumab concerning inflammatory control and inhibition of erosive     development.      Optimized Treatment Algorithms for Patients with Early RA   "
215198|NCT00660660|"     The purpose of this research study is to compare the safety and effectiveness (how well the     medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any     medication) taken daily in relieving nighttime heartburn and problems sleeping in patients     with gastroesophageal reflux disease (GERD).   "
216248|NCT00674492|"     Qualitative pilot study of patients' views of their experience with antiviral treatment for     hepatitis C.   "
215204|NCT00660738|"     Objectives: to evaluate and compare the responses to the various functional tests, and the     concordance between the six-minute walk test in hallway (6MWT) and the of oval track     (6MWToT), of treadmill (6MWTT), and of treadmill with inclination (6MWTTI), the six-minute     step test (6MST) and the sit-to-stand test (STST), in patients with Chronic Obstructive     Pulmonary Disease (COPD), and to correlate the responses with functional state and quality of     life. Methods: Ten patients with COPD (71±8years, FEV1<80%predicted) were assessed using the     functional tests. A dyspnea was assessed using the London Chest Activity of Daily Living and     the Medical Research Council scales; and the quality of life was assessed using the St     George's Respiratory Questionnaire (SGRQ).   "
215205|NCT00660751|"     The role of central serotonergic and adrenergic systems in the effectiveness of DNIC (Diffuse     Noxious Inhibitory Control) will be tested before and after taking Duloxetine and Placebo in     a double blind study.   "
215206|NCT00660764|"     In an observational multi-centre study (HEROS), the effects of starting treatment with     rosuvastatin were assessed, on low-density lipoprotein cholesterol (LDL-C) goal achievement,     in patients with a dissimilar high-risk profile who had not been treated with cholesterol     lowering drugs at least in the past three months. Also set-up costs of rosuvastatin treatment     and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were     studied.   "
215207|NCT00660777|"     Background: Upper airway muscle weakness plays an important role in the genesis of     obstructive sleep apnea (OSA). Oropharyngeal exercises are derived from speech therapy     consisting of isometric and isotonic exercises directed to tongue, soft palate and lateral     pharyngeal wall. We hypothesized that oropharyngeal exercises will attenuate OSA severity.      We will include 30 moderate OSA patients (apnea-hypopnea index (AHI), between 15 and 30     events/hour) that will randomize to 3 months of general measurements and daily nasal lavage     (n=15, control) or daily oropharyngeal exercises (~30 min) plus nasal lavage (n=16). Full     polysomnography, anthropometric measurements, questionnaires derived from Berlin, Epworth and     Pittsburgh evaluating quantitatively (range) snoring frequency (0-4) and intensity (1-3),     daytime sleepiness (0-24) and sleep quality (0-21), respectively will be performed at     baseline and study end.   "
215208|NCT00660790|"     The aim of the study is to develop a model that allows early identification of type-2     diabetic patients who will face progressive atherosclerosis despite intensive,     multifactorial, target oriented treatment   "
215209|NCT00667160|"     A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic     Dermatitis in pediatric patients   "
215210|NCT00667173|"     The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating     patients with rosacea.   "
215211|NCT00667186|"     Late diagnosis of HIV infection is believed to be responsible for high rates of HIV     transmission. The purpose of this study is to determine whether targeted screening versus     routine screening will identify a greater number of HIV infected participants. This study     will also compare the costs of the resources used for targeted screening versus routine     screening.   "
215212|NCT00667199|"     The purpose of this study is to evaluate the efficacy and safety of the investigational     radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and     bone metastases that no longer respond to hormonal treatment.   "
215213|NCT00667212|"     The goal of this study is to examine the effectiveness two forms of psychotherapy (also known     as talk therapy ) for individuals with anger and aggression problems. Anger and aggression     are everywhere - on the road, in the schools, at little league games, at home, and at work.     In this study we are testing usefulness of anger management techniques in reducing symptoms     of Intermittent Explosive Disorder (IED) and impulsive, aggressive behavior.   "
215214|NCT00667225|"     The University of North Carolina Department of Dermatology is conducting a clinical trial to     evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a     common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many     flesh-colored bumps on the skin. It goes away on its own, though can last several months to     several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is     well tolerated by the majority of children.   "
215215|NCT00667238|"     The purpose will be to study the functional impact of pediatric chronic pain on children, and     their families. Focus will be on the impact of pain on school functioning, social     functioning, psychological functioning and family functioning of pediatric chronic pain.   "
215267|NCT00667940|"     We will conduct a faculty development workshop with intent to improve interrater reliability     and rater accuracy. Outcomes will include interrater reliability, accuracy, and workshop     evaluations.   "
215268|NCT00667953|"     This study has been designed to evaluate the side effects of Gleevec when given in     combination with Temzolomide; and to learn more about how these drugs work in the body and     whether this combination is useful in treating patients with melanoma.   "
215269|NCT00667966|"     Assess efficacy of Vardenafil in patients with traumatic spinal cord injury   "
215274|NCT00668031|"     The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during     surgery, is safe and can help reduce the amount of bleeding and the need for a blood     transfusion during hip replacement surgery. Patients undergoing major surgery are at risk for     significant blood loss. Because of this, there is a need for drugs that will help slow the     amount of bleeding during surgery.   "
215277|NCT00668070|"     The aim of this study is to explore the effect of a new drug (ASP9831) in patients with     non-alcoholic steatohepatitis (NASH) by assessing clinical signs, laboratory data and     biomarkers during a 12 week treatment period   "
215278|NCT00668083|"     Observational Retrospective trial on sequential hormonal therapy in patients with Prostate     Cancer   "
215279|NCT00668096|"     The objective of this study was to evaluate the efficacy and tolerability of the     phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of     subjects with erectile dysfunction of different aetiologies and severity, who have not been     previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.   "
215280|NCT00668109|"     Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes,     hypertension or hyperlipidemia   "
220428|NCT00736983|"     To assess whether a combination of ciprofloxacin and adalimumab is more effective than     adalimumab alone for the treatment of perianal fistulas in Crohn's disease   "
215216|NCT00667251|"     RATIONALE: HER2/neu is a receptor (protein) which is found in unusually high amounts in     approximately 1 in 5 cancer patients. Scientific evidence suggests that having high amounts     of the HER2/neu receptor is important for breast cancer to grow and spread. Women with     previously untreated metastatic breast cancer (breast cancer that has spread to other organs)     and with high levels of the HER2/neu receptor receive as their usual treatment chemotherapy     with one of the approved chemotherapy drugs paclitaxel or docetaxel (called taxanes)     together with another approved drug called trastuzumab. Chemotherapy drugs, such as     paclitaxel and docetaxel, work either by killing tumour cells or by stopping them from     dividing. Trastuzumab is an antibody that is given through a vein in the arm and it works by     specifically targeting the HER2/neu i.e. it attaches to it and turns it off. Although     some of the patients who receive this taxane plus trastuzumab treatment feel better for some     months, the cancer usually starts to grow again. Lapatinib is a new drug. Like trastuzumab,     it also works by specifically targeting the HER2/neu receptor, but it does so in a     different way. Lapatinib is not an antibody. It is a pill that is taken daily by mouth.     Because lapatinib works in a different way than trastuzumab, it may be worse, as good as or     better than trastuzumab in keeping metastatic HER/neu positive cancer from growing. However,     this is not known.      Purpose: This randomized Phase III trial is comparing chemotherapy (a taxane) given together     with lapatinib with chemotherapy (a taxane) given together with trastuzumab in women with     HER2/neu positive breast cancer.   "
215217|NCT00667264|"     Research study to determine if putting local anesthetic—or numbing medication—through one or     two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom     limb and/or stump pain.   "
215218|NCT00667277|"     Myelofibrosis is the gradual replacement of bone marrow (place where most new blood cells are     produced) by fibrous tissue which reduces the body's ability to produce new blood cells and     results in the development of chronic anemia (low red blood cell count). One of the main     distinctions of myelofibrosis is extramedullary hematopoiesis, the migration or traveling     of the blood-forming cells out of the bones to other parts of the body, such as the liver or     spleen, resulting in an enlarged spleen and liver.      There is not a standard treatment for myelofibrosis, therefore there is no medication that is     specifically used in the treatment of myelofibrosis. Bevacizumab (Avastin®) targets and stops     a growth factor in the body that helps produce the type of fibrous tissue that is gradually     replacing the bone marrow in the bones.      The purpose of this study is to find out how safe and effective bevacizumab is in treating     myelofibrosis. The investigators also wish to find out important biologic characteristics or     features of myelofibrosis (how it works and operates) during the time of study participation     through an additional correlative biomarker study (MPD-RC #107). The purpose of the biomarker     study is to understand the causes of MPD and to develop improved methods for the diagnosis     and treatment of these diseases, while the main study is trying to find out how well     bevacizumab will work in treating the disease.   "
215219|NCT00667290|"     The purpose of this study is (1) to determine whether a 3-month exercise rehabilitation     program will improve claudication distances, free-living daily physical activity, and     health-related quality of life of older, revascularized patients with peripheral arterial     disease, and (2) to determine whether the primary mechanisms by which exercise rehabilitation     affects the above functional outcomes are through alterations in walking efficiency,     peripheral circulation, and cardiopulmonary function.   "
215220|NCT00667303|"     The Study aims to prospectively survey the incidence of respiratory virus infections using     molecular methodologies, in children undergoing hematopoietic stem cell transplantation   "
215221|NCT00667316|"     The purpose of this study is to determine, in Spanish workers, the influence of different     factors (personal, psychological, work related and clinical) on the risk of being on sick     leave during the 18 months after baseline assessment, and on the duration of that sick leave.   "
215222|NCT00667329|"     The goal of this clinical research study is to see how well the drugs 2CdA, cyclophosphamide,     and rituximab (rituxan) shrink a lymphoma called Waldenstrom's macroglobulinemia. After these     drugs are given for 2 courses, a second goal is to see how long a remission lasts. A third     goal is to see how often repeat remissions can be achieved when the lymphoma returns later     and the same drugs are restarted.   "
215223|NCT00667342|"     This study adopts a novel strategy for first-line treatment of osteosarcoma by combining     chemotherapy with anti-angiogenic therapy using bevacizumab (Avastin®), a humanized     monoclonal antibody against vascular endothelial growth factor (VEGF). Chemotherapy for     localized disease comprises a 3-drug regimen (cisplatin, doxorubicin, and high-dose     methotrexate). Chemotherapy for metastatic or unresectable disease comprises a     cisplatin-based regimen that includes high-dose methotrexate, doxorubicin, ifosfamide, and     etoposide.   "
215224|NCT00667355|"     To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with     active ankylosing spondylitis   "
215225|NCT00667368|"     The purpose of this study is to determine whether regular screening (every 2 months) and     treatment for bacterial vaginosis (BV [infection of the vagina]) will reduce the number of     incidences of chlamydia and gonorrhea (sexually transmitted diseases) over the course of a     year. Chlamydial and gonococcal infections will be determined by vaginal swab testing at 4,     8, and 12 months after enrollment. Subjects will include 1500 women aged 15-25 years who have     clinical evidence of BV, with no symptoms. Subjects will be randomly assigned to 1 of 2     possible study groups: the intervention group (treatment of BV) or the control group (no BV     treatment). Every 2 months, subjects will complete a home self-testing kit for screening of     BV using a swab. If BV is detected by self-test, the subjects in the interventional group     will receive a 7 day course of the antibiotic metronidazole. Participants will be involved in     study related procedures for up to 12 months.   "
215226|NCT00667381|"     This study is designed to evaluate the routine use of vascular ultrasound as an aid for     proper placement of a femoral arterial sheath during cardiac catheterization and peripheral     arterial angiography.   "
215275|NCT00668044|"     This was a non randomised, multi center, italian study performed in burn patients receiving     an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study was     to validate a pharmacokinetics model useful to verify if a standard dose regimen of     ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead     is over or under dosed.   "
215227|NCT00667394|"     Background:      In order to survive, brain tumors must have a network of blood vessels to supply it with     oxygen and nutrients. The tumors produce substances that enable new blood vessels to form.      Tandutinib and Bevacizumab are experimental drugs that may prevent new blood vessel formation     and thereby slow or stop tumor growth in the brain.      Objectives:      To determine the safety and side effects of Tandutinib in combination with Bevacizumab in     patients with brain tumors.      To evaluate the response of brain tumors to treatment with Tandutinib and Bevacizumab.      Eligibility:      Patients 18 years of age and older with a malignant brain tumor for whom standard treatments     (surgery, radiation and chemotherapy) are no longer effective.      Design:      Patients receive treatment in 4-week cycles as follows: Tandutinib by mouth twice a day every     day and intravenous (through a vein) infusions of Bevacizumab over 90 minutes (or less if     well tolerated) every 2 weeks. Treatment may continue for up to 1 year, and possibly longer,     as long as there are no signs of tumor growth or serious treatment side effects.      Patients are evaluated with magnetic resonance imaging (MRI), computed tomography (CT) and     positron emission tomography (PET) scans before starting treatment and then periodically to     determine the response to treatment.      Patients have physical and neurological examinations every 4 weeks and blood tests every 2     weeks. They complete quality of life questionnaires every 4 weeks.   "
215228|NCT00667407|"     To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the     Treatment of Acute Asthma.   "
215229|NCT00667420|"     A pilot study to determine the safety of using perioperative panitumumab with EOX     (epirubicin, oxaliplatin, and capecitabine) in patients with adenocarcinoma of the esophagus     and stomach.   "
215230|NCT00667433|"     This is a single arm, longitudinal study to examine the safety, tolerability, and     pharmacokinetic and metabolic characteristics of Raltegravir among 40 African-American,     HIV-infected, patients.   "
215231|NCT00667446|"     The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30     mg) is safe in treating children with Central Precocious Puberty over a longer period of time     (36 months).   "
215232|NCT00667459|"     The purpose of this clinical trial is to evaluate the safety and effectiveness of the     PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical     degenerative disc disease at a single level from C3-C4 to C6-C7.   "
215233|NCT00667472|"     The purpose of this study is to improve port wine stain therapeutic outcome in response to     laser therapy. The researcher want to determine whether the combined use of pulsed dye laser     therapy and topical ranibizumab will improve port wine stain therapeutic outcome.   "
215234|NCT00667485|"     The goal of this trial is to determine the toxicity and maximum dose of rapamycin and     bevacizumab given together to subjects with advanced cancers. This study will also look at     the pharmacokinetics and antitumor activity of the combination.   "
215235|NCT00667524|"     A database analysis and review of histological slides (retrospective) and a patient     questionnaire analysis (prospective) will be conducted in Bern (Switzerland) to evaluate the     efficacy and safety of esophageal dilation and its effect on the underlying eosinophilic     inflammation in patients with Eosinophilic Esophagitis. This trial is investigator driven.   "
215236|NCT00667537|"     Primary objective: To investigate the biodistribution, radiation dosimetry, and     pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body     weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology     standardization], 6 weeks apart).      Secondary objectives: To determine the safety of IV injections of Xofigo after two separate     injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic     bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w.     (=110 kBq/kg based on the 2015 National Institute of Standards and Technology     standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect     survival data at 6 and 12 months after the first injection   "
215237|NCT00667550|"     This is a prevalence study evaluating lower urinary tract, prolapse, bowel, and sexual     symptoms in women with a colorectal disorder who are planning to undergo surgery.      The purpose of this study is to identify the number of women who complain of lower urinary     tract and bowel problems, including frequency, urgency, urinary incontinence, fecal     incontinence, pain with intercourse, and other sexual problems prior to undergoing surgical     management for a colorectal disorder.   "
215238|NCT00667563|"     RATIONALE: Vaccines made from virus proteins may help the body build an effective immune     response to prevent cervical cancer.      PURPOSE: This pilot study is looking at the side effects of a human papillomavirus vaccine     and how well it works in preventing cervical cancer in women in India with HIV-1 infection.   "
215239|NCT00667576|"     The purpose of this study was to investigate the initial dose and dose adjustment range for     paricalcitol injection in patients with chronic kidney disease on hemodialysis who have     secondary hyperparathyroidism.   "
215240|NCT00667589|"     The purpose of this study is to evaluate treatments for a rash caused by sorafenib.   "
215241|NCT00667602|"     The primary immunogenicity objective is to assess and compare the immunogenicity of one dose     of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured     by the percentage of subjects with serum bactericidal titers directed against N. meningitidis     serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).   "
215270|NCT00667979|"     Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection     sufficient for satisfactory sexual performance. However, there remains no prospectively     obtained data on the maximal time of effectiveness of vardenafil. The goal of the current     study was to determine if vardenafil will significantly increase the percentage of successful     intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12,     18, and 24 hours were assessed in this pilot study to better quantify the effect of     vardenafil.   "
215271|NCT00667992|"     This study is being carried out to see if budesonide with HFA is effective, safe and well     tolerated compared with budesonide CFC. Budesonide HFA has been already given in other     research studies, in both healthy volunteers and subjects with asthma.   "
215272|NCT00668005|"     Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure   "
215273|NCT00668018|"     Assess efficacy of vardenafil within 6 hours after intake   "
215242|NCT00667615|"     The purpose of this study is to replace a drug with many side effects, procarbazine, with a     new novel drug, vorinostat, in a drug combination for the treatment of patients with diffuse     large B-cell lymphoma. Vorinostat is the first of a new type of chemotherapy drug, known as a     histone deacetylase inhibitor, to be approved by the Food and Drug Administration. It is     approved for the treatment of certain lymphomas of the skin. It alters the cancer cell     pathway by preventing cancer cells from reproducing. Vorinostat will be added to a     combination of four other effective chemotherapy drugs that have been used for many years for     the treatment of diffuse large B-cell lymphoma: rituximab, cyclophosphamide, etoposide and     prednisone. The doses of vorinostat will be increased or decreased depending on the side     effects that occur in each of the first few patients in the trial to find the safest dose     with the least side effects. This is termed the phase I part of the clinical trial. Once the     best dose of vorinostat is found, the rest of the patients in the clinical trial will be     treated with this dose. This is termed the phase II part of the trial. The object of the     trial is to find out what effects, good and/or bad, the combination of vorinostat, rituximab,     cyclophosphamide, etoposide and prednisone will have on you and your lymphoma.   "
215243|NCT00667628|"     The purpose of this study is to determine whether TAC-101 combined with Transcatheter     Arterial Chemoembolization (TACE) is more effective than TACE alone in slowing tumor activity     in patients with advanced hepatocellular carcinoma. The study is also looking at the safety     of TAC-101 in combination with TACE.   "
215244|NCT00667641|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving paclitaxel together with bortezomib may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel and     bortezomib in treating patients with metastatic or unresectable malignant solid tumors.   "
215245|NCT00667654|"     This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when     delivered as an intra-articular injection in the knee. Secondary objectives will be to     explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.   "
215246|NCT00667667|"     There is general agreement that physical exercise can positively influence osteoporotic     fracture risk along two pathways: first by reducing the risk of falls via an improvement of     fall related neuromuscular abilities; second by increasing bone strength.      Whole body vibration (WBV) training has recently been proposed as a new approach for     prevention and treatment of osteoporosis. Animal studies have shown evidence that WBV may be     an effective method to improve bone mass, architecture and strength. However, the results of     human WBV training studies are rather heterogeneous.      In the Erlangen Longitudinal Vibration Study II (ELVIS II), a randomized, controlled 12 month     lasting study the investigators determine the effect of a thrice weekly WBV training on two     different devices on the osteoporotic risk factors: bone mineral density, falls and     neuromuscular performance. Particular the investigators compare a bipedal vertical     oscillating Plate with a plate which rotates around a central axis leading to a     side-alternating loaning.   "
215247|NCT00667680|"     tDCS applies a small amount of direct electric current (DC) to the brain by means of two     electrodes: the one is an active electrode, localized on the effective site, and the other is     a reference electrode, localized on some silent part of the body. Anodal transcranial     direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPFC) has been     associated with working memory enhancement and improvement of mood. This study will     investigate the possible antidepressant effects of tDCS in patients with therapy resistant     major depressive episodes.   "
215248|NCT00667693|"     This study will compare the Macintosh laryngoscope with the Pentax. The Pentax AWS is a novel     airway management device that is designed to facilitate laryngoscopy and endotracheal     intubation.   "
215249|NCT00667706|"     The sleeve gastrectomy that has been utilized as a first-stage bariatric procedure to reduce     surgical risk in high-risk patients by induction of weight loss is now gaining popularity as     a standalone procedure for the treatment of morbid obesity. It appears to be a technically     easier and/or faster laparoscopic procedure than Roux-en-Y gastric bypass. It brings good     weight loss results, in some studies even comparable to the RYGB and Biliopancreatic     Diversion with Duodenal Switch.      The mechanism of action is assumed to be purely restrictive, but some neurohumoral     interaction may exist. Almost no data exist on the influence of the sleeve gastrectomy on the     medical and general quality of life or resolution of comorbidities.      The rates of the comorbidities resolution 12 to 24 months after sleeve gastrectomy has been     reported in the range that seems to be higher than for the purely restrictive procedures.      Our goal is to to compare the surgical and weight loss outcomes between the two procedures,     their influence on resolution of common comorbidities and on quality of life change.      150 eligible candidates will be randomized into two groups, one will undergo Laparoscopic     Sleeve Gastrectomy, the other will have Laparoscopic Roux-en-Y Gastric Bypass done. Detailed     evaluation and preoperative questionnaires will be used to obtain demographic and medical     data, and quality of life will be assessed.      General metabolic and nutritional work up will be done, and will be reassessed at different     intervals up to 5 years, in order to compare the short and long term results of the two     procedures.   "
215250|NCT00667719|"     This study will test the safety of the combination of     aliskiren/amlodipine/hydrochlorothiazide in patients with essential hypertension   "
215251|NCT00667732|"     This study is designed to look at how using glargine insulin with oral diabetes medications     and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics.      The main study will last 32 weeks. However, all participants completing 32 weeks will be     invited to continue for another 24 weeks taking the insulin and oral medication and exenatide     treatment. This extension comparing insulin and oral medication with insulin and oral     medication and exenatide will look at the long term weight loss/gain and blood sugar level     control effects of this new drug regimen.      There is also a sub-study in the Clinical Research Center (CRC), which requires two 38-hour     inpatient stays during the main study. This study offers the opportunity to study 24-hour     blood sugar and metabolic patterns quantitatively.   "
215252|NCT00667745|"     This study evaluated whether lithium included as part of optimized medication treatment     improved overall level of illness, symptoms of mania and depression, and quality of life in     people with bipolar disorder.   "
215254|NCT00667771|"     This study will determine whether naltrexone, a medicine used to treat alcoholism, can lessen     the craving for alcohol during alcohol withdrawal and examine how the drug affects brain     activity during alcohol infusion.      People between 21 and 50 years of age who are right-handed, alcohol-dependent, and have at     least one family member with a history of alcoholism, may be eligible for this study.      Participants are admitted to the NIH Clinical Center for 1 month for the following     procedures:      Screening        -  Medical history, alcohol-use history and family history of alcoholism        -  Physical examination, psychological tests and blood tests        -  Medicine to lessen alcohol withdrawal symptoms, if necessary      Days 1-7        -  Alcohol detoxification        -  Medical and psychological evaluations        -  Assignment to naltrexone or placebo group      Days 7 through 28        -  Drug treatment: Take naltrexone or placebo capsule every morning        -  Additional alcohol-dependence treatment: Cognitive and behavioral therapies and          participation in self-help groups, such as Alcoholics Anonymous        -  Weekly questionnaires to measure mood and desire for alcohol        -  Blood tests        -  Alcohol craving stimulation test (day 7): Subjects handle and sniff water and then their          favorite alcoholic beverage. They then rate their urge to drink alcohol and their level          of anxiety and their heart rate is measured.        -  Alcohol infusion test (day 9): Subjects have an MRI scan during infusion through a vein          of saline (salt water), followed by infusion of alcohol. For this test, a catheter          (plastic tube) is placed in a vein in each arm, one for administering the saline and          then alcohol; the other for drawing blood samples to measure blood alcohol level and          body chemistries. Before, during and after the infusion, subjects are asked to respond          to questions about their feelings, cravings and mood changes.      Follow-up      Subjects are asked to participate in a 3-month outpatient assessment program involving five     outpatient visits (at 1, 2, 4, 8 and 12 weeks after discharge). At each visit, they fill out     questionnaires and to take a breathalyzer test and blood and urine tests for drugs. They may     continue naltrexone therapy and weekly group therapy sessions during this time. Subjects who     do not participate in the assessment program are contacted at home by phone once a week for 1     month and then every other week for the next 2 months to monitor alcohol abstinence.   "
215255|NCT00667784|"     The goal of this research study is to understand what it is like for a young person to have a     sick family member and what it is like to donate bone marrow or stem cells for a sick family     member.      Primary Aims:        1. Compare minor donor adjustment to minor non-donor adjustment, including anxiety,          self-esteem, traumatic stress, achievement, and behavior.        2. Evaluate minor donor adjustment across time, including self -esteem, traumatic stress,          anxiety, achievement, and behavior.        3. Investigate the effect of the following on donor well-being:             -  Donor variables: 1) the impact of the harvest, including type of harvest (needle               aspiration of bone marrow or peripheral blood stem cell collection by apheresis               after injection of G-CSF), pre-procedural anxiety and perceived pain; 2) age of               donor at time of transplant, 3) gender, 4) preparedness for transplant, 5) sibling               order (for sibling participants), and 6) donor's decision-making and ambivalence               regarding donation.             -  Recipient variables: 1) the recipient's level of well-being or death, 2) genetic               versus acquired disease types, and 3) familial relationship of donor to recipient.             -  Family support variables: 1) the distress of the family, 2) the quality of the               relationship between the potential donor and the recipient, and 3) parent's               well-being (post-traumatic stress disorder or PTSD, depression).      Secondary Aim:      Evaluate satisfaction with the donor program.   "
215256|NCT00667797|"     An analysis of the costs and outcomes associated with hospitalization and treatment of     Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD.   "
215257|NCT00667810|"     This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in     patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab     or placebo. Each patient's participation will last approximately 1.5 years.   "
215258|NCT00667823|"     The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055     302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in     patients with symptomatic PAH.   "
215259|NCT00667836|"     We propose to establish a multi-center study to investigate the outcome of scoliosis and     spinal abnormalities in patients with NF1.      The three specific aims of this study are:      Specific Aim 1 - To assess health status and health-related quality of life (HRQL) in     children and adolescents with NF1 and scoliosis. We hypothesize that children and adolescents     with NF1 and scoliosis will experience an additional burden of morbidity due to scoliosis and     a downward trajectory of health status and HRQL over time.      Specific Aim 2 - To assess the natural history and short-term response to therapy in a cohort     of children with NF1 and scoliosis prospectively diagnosed during the course of the four-year     study period. We hypothesize that some NF1 patients with idiopathic scoliosis will modulate     to the dystrophic form. We also hypothesize that NF1 patients with earlier presentation are     more likely to have or modulate to the dystrophic form.      Specific Aim 3 - To assess biochemical markers of bone metabolism in NF1 individuals. We     hypothesize that NF1 individuals will have statistically significant differences in     biochemical markers of bone metabolism compared to controls. We also hypothesize that NF1     individuals with scoliosis will have differences in biochemical markers of bone metabolism     compared to NF1 individuals without scoliosis.   "
215260|NCT00667849|"     The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on     tibial fractures treated with intramedullary nailing.   "
215261|NCT00667862|"     This Phase II single dose study is designed to characterize the safety, tolerability and     efficacy of i.v. panobinostat as a single-agent treatment in patients with hormone refractory     prostate cancer.   "
215262|NCT00667875|"     The principal aim of this exploratory study is to examine whether the addition of     aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week     randomized, placebo-controlled clinical trial, in which all subjects will be provided medical     management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication     treatment will reduce drinking compared to placebo treatment alone in the context of medical     management and whether naltrexone plus aripiprazole will reduce drinking compared to     naltrexone treatment alone in the context of medical management.   "
215263|NCT00667888|"     The goal of this clinical research study is to compare using external beam radiotherapy with     intensity modulated beams for fewer days at a higher dose per day to the same type of therapy     for more days at a lower dose per day in the treatment of prostate cancer. The safety of     these treatments will also be studied and compared.   "
215264|NCT00667901|"     RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective     treatment for melanoma.      PURPOSE: This early phase I trial is studying how well riluzole works in treating patients     with stage III or stage IV melanoma that can be removed by surgery.   "
215265|NCT00667914|"     The intention is to evaluate the effectiveness of a multi-factorial medical treatment of     patients with hip fractures in a specially designed unit for elderly hip fracture patients     (orthogeriatric unit) as compared to traditional care in an orthopedic unit.   "
215283|NCT00668148|"     This multicenter study will enroll approximately 185 participants with metastatic or advanced     sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication.     Participants will be stratified into five tiers according to diagnosis:        1. Ewing's sarcoma/PNET        2. rhabdomyosarcoma        3. leiomyosarcoma        4. adipocytic sarcoma        5. synovial sarcoma.      A total of 85 patients will be enrolled initially, 17 in each tier. Participants will receive     single agent IMC-A12 every 2 weeks. A treatment cycle will be defined as 6 weeks, with     radiological evaluation every cycle.      Safety and response in the initial 17 patients in each tier will be used to determine whether     to extend enrollment to the target total of 37 patients per tier.   "
215284|NCT00668161|"     There is strong observational epidemiologic evidence that physical activity is inversely     associated with risk of colon cancer occurrence in both men and women. This association has     been found in over 30 observational studies, and appears to be independent of effects of     diet, body fat mass, and other potential confounding factors. Prior to large-scale     recommendations regarding exercise as a means of preventing colon cancer, however, more     information is needed regarding the type of exercise, when it must be initiated, and how much     must be done, in order to produce a protective effect. Information on the mechanisms and     biological pathways through which exercise might protect the colon will aid in developing the     answers to these questions.      This is a randomized controlled trial of a one-year moderate/vigorous exercise intervention     vs. delayed- exercise control on various biomarkers of colon cancer risk in persons that have     undergone a colonoscopy within the past 36 months.. The trial is designed to establish the     effects of the exercise intervention on colorectal cell proliferation and terminal     differentiation, and on factors that may lie in the pathway between exercise and     proliferation and apoptosis, in colon and rectal epithelium. It will provide data on: 1) the     efficacy of a one-year moderate intensity aerobic exercise program in modulating these     processes to a pattern considered low risk for colon cancer, and 2) the mechanisms whereby     exercise may lower colon cancer risk in humans. To the investigators' knowledge, this will be     the first study of its kind.   "
215285|NCT00668174|"     The goals of the study are to examine the effect in postmenopausal women of a one-year     moderate intensity exercise intervention, as compared with a sedentary pattern (low-level     stretching program), on: serum estrogens, androgens, sex hormone binding globulin, insulin,     triglycerides, glucose, aromatase, FSH, LH, as well as parameters of body fat mass.   "
215286|NCT00668187|"     Hypothesis: To characterize and describe disease progression and heterogeneity of the     gangliosidosis diseases.      This research study seeks to develop a quantitative method to delineate disease progression     for the gangliosidosis diseases (Tay-Sachs disease, Sandhoff disease, and GM1 gangliosidosis)     in order to better understand the natural history and heterogeneity of these diseases. Such a     quantitative method will also be essential for evaluating any treatments that may become     available in the future, such as gene therapy. The data from this study will be necessary to     provide end-points for future therapies, guide medical decisions about treatment, provide     objective measurement of treatment outcomes, and accurately inform parents regarding     potential outcomes.   "
215287|NCT00668200|"     This study will evaluate the impact of investigator and patient education and educational     materials to foster calcium and vitamin D supplementation to mitigate the potential for     hypocalcemia post Reclast® administration in patients with Paget's disease of bone.   "
215288|NCT00668213|"     Objective:      The objective of this study was to determine whether the antioxidant supplements used in     AREDS shifted the plasma pool of the AREDS subjects to a more reduced state. The AREDS     subjects were randomly assigned to one of four treatment groups:        1. antioxidants (500mg Vitamin C, 4000IU Vitamin E, 15mg beta carotene)        2. zinc (80mg zinc oxide, 2mg cupric oxide)        3. antioxidants plus zinc;        4. placebo.      None of the subjects received supplemental GSH or cyst (e) ine.      Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in     elderly Americans, with an estimated 15 million people having some form of this disease. AMD     primarily affects the central vision and many patients develop severe visual handicaps.      Currently there are no clear established understandings of the etiology or pathogenesis of     this disease.   "
215289|NCT00668226|"     The purpose of this study is to prove the absence of photo irritation and photo sensitivity     potential of the product Dermacyd Delicata Pocket BR.   "
215290|NCT00668239|"     This study compares the use of intravitreous triamcinolone and laser therapy to treat     maculopahty in patients with type 2 diabetes mellitus in a short-tem period of 6 months   "
215291|NCT00668252|"     The purpose of this study is to determine whether the number of circulating EPC is different     between healthy women and men.   "
215350|NCT00669019|"     This phase II trial is studying how well saracatinib works in treating patients with stage     III or stage IV melanoma that cannot be removed by surgery. Saracatinib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth   "
215292|NCT00668265|"     This is a 16 week study of the efficacy of quetiapine in treating symptoms of generalized     anxiety disorder (GAD) in subjects with comorbid opiate dependence. The study will be     conducted in a prospective, randomized, double-blind, and placebo-controlled fashion. Study     subjects will be inpatients at a residential drug-treatment facility, enrolled in a 1 year     methadone-to-abstinence treatment plan. Subjects will be randomized to receive either     quetiapine or placebo in addition to ongoing drug addiction treatment. Subjects will be     followed for 16 weeks and a variety of psychometric assessments will be made.      Hypothesis One: Compared to placebo, Quetiapine will demonstrate a greater reduction in     symptoms of anxiety in subjects with GAD and remitted comorbid opiate abuse.      Exploratory Hypotheses: Compared to placebo, Quetiapine will demonstrate a greater     improvement in psychosocial functioning and compliance with community norms in subjects     enrolled in a residential drug addiction treatment facility.   "
215293|NCT00668278|"     Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask     Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak     airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs.      Hypothesis      There is no difference between the performance* of the I-gel and disposable laryngeal mask     airways for controlled ventilation under general anesthesia.      *as defined by peak airway pressure and sealing pressures.   "
215295|NCT00668304|"     This study evaluated the time to bacteriological eradication of common pathogens during     moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the     time to resolution of key symptoms associated with sinusitis.   "
215296|NCT00668317|"     The study aim is to determine the effect of 8 weeks of anti-reflux treatment (full acid     suppression) on bronchial hyper-responsiveness and whether there is a symptomatic     improvement.   "
215297|NCT00668330|"     The primary aim of the present study was to investigate the prevalence of low bone mineral     density (BMD) and vertebral fractures, as determined by a standardized assessment, and to     elucidate the role of bone qualities, including micro-architecture, bone remodeling, bone     turnover, mineralization and inflammation on bone density and prevalent vertebral fractures     in a large population of systemic lupus erythematosus (SLE) patients.      The secondary aim of the study is to evaluate the following parameters in women with steroid     induced OP (SIOP) before and after 1 year of treatment using:        1. The changes in BMD using dual energy X-ray absorptiometry (DXA)        2. Bone mineralization and architecture in-vivo using a newly available high-resolution          human micro-computed tomography (ExtremCT), which can provide us with new insights into          how the degree and distribution of mineralization are affected by long-term oral          Ibandronate treatment.        3. Changes in perfusion and marrow edema before and after treatment of Ibandronate using          dynamic Magnetic Resonance Imaging (MRI) in these patients with SIOP.        4. The investigators prospectively evaluate the correlation between the changes in brachial          arterial endothelial function and lumbar spine BMD in female lupus patients over the          period of 1 year.   "
215298|NCT00668343|"     Patient with relapsing remitting multiple sclerosis taking avonex are included in this double     blind randomized control trial. Simvastatin is compared to placebo. end points of edss ,     total attack, new enhancing lesion and newt2 lesion in mri is evaluated as end point.   "
215299|NCT00668356|"     The purpose of this study is to show that the administration of 400/mg/m2/day of     didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of     didanosine during fasting, in HIV infected children treated by a ARV combination including     ddI   "
215300|NCT00668369|"     Viral infections can profoundly influence alloimmune responses and hamper allograft tolerance     induction. Persistent hepatitis C virus (HCV) infection occurs in 50% of liver and 20% of     kidney transplant recipients, but the impact of HCV on the acquisition of allograft tolerance     has not been elucidated. Liver transplantation constitutes a unique clinical model to address     this question, given that up to 20% of liver recipients can completely discontinue     immunosuppressive drugs and attain operational tolerance.      The goal of our study is to determine the influence of HCV-driven immune responses on the     acquisition of operational tolerance in liver transplant recipients following drug weaning,     and to assess whether immunosuppression withdrawal ameliorates HCV-induced liver damage.      This is a prospective trial in which immunosuppressive drug weaning will be offered to     HCV-positive liver recipients (selected on the basis of a high likelihood of tolerance) as a     strategy to improve HCV-mediated liver disease.   "
215301|NCT00668382|"     This is a Phase I pilot study to evaluate the toxicity and feasibility of intratumoral     injection (Glycosphingolipids) GSL alpha-GAL (beta-galactosidase) in patients with advanced,     refractory solid tumors who have failed standard therapies or are not eligible for standard     treatment.   "
215302|NCT00668395|"     1. To see how the liver breaks down efavirenz by an enzyme called CYP2B6. It is suggested          that when Efavirenz is taken repeatedly it may increase the amount of CYP2B6 in your          liver and thus speed up your liver's ability to get rid of efavirenz from your body.          This may render efavirenz and other medications ineffective.        2. To see how efavirenz interact with other drugs taken at the same time with it.        3. To see if genetic differences can change the way how the liver breaks down efavirenz and          its interactions with other co-administered drugs.   "
215303|NCT00668408|"     In patients with both COPD and CHF, moderate chronic hypoxemia is caused by a combination of     intrapulmonary and extrapulmonary factors. The hypothesis of this study is that adequate     medical therapy for both conditions can correct the moderate hypoxemia by improving the     underlying mechanisms without the need of LTOT. If this hypothesis is correct, the study will     provide a valuable information to the Italian Agency of drugs (Agenzia Italiana del Farmaco,     AIFA) to reduce the inappropriate use of LTOT for COPD patients with moderate hypoxemia and     CHF, and will help the Italian National Health Service to reduce both the direct and indirect     costs of unnecessary LTOT.   "
215351|NCT00669032|"     The main objective is the long-term comparison (3 years and 4 months) of the efficacy and     safety of repeated intra-articular administration of hyaluronic acid in the treatment of     osteoarthritis of the knee.   "
215304|NCT00668421|"     Myelofibrosis is the gradual replacement of bone marrow (place where most new blood cells are     produced) by fibrous tissue which reduces the body's ability to produce new blood cells and     results in the development of chronic anemia (low red blood cell count). One of the main     distinctions of myelofibrosis is extramedullary hematopoesis, the migration or traveling of     the blood-forming cells out of the bones to other parts of the body, such as the liver or     spleen, resulting in an enlarged spleen and liver.      Treatment for myelofibrosis is unsatisfactory and there is no medication that is specifically     used in the treatment of myelofibrosis. There is a protein that is found to be present in the     majority of myelofibrosis patients (JAK2) and the drug Lestaurtinib is being studied to see     if it will stop this protein from functioning and thereby help control the disease.      This study is divided into two Phases (1 & 2). In phase 1 we will be looking for the dose of     study medication (Lestaurtinib) that will be the highest dose a patient can take without     experiencing serious side effects, maximum tolerated dose (MTD).      In phase 2, after the MTD dose has been established in phase 1, we will be investigating how     well CEP-701 (Lestaurtinib) works at suppressing the protein (JAK2).      The investigators also wish to find out important biologic characteristics or features of     myelofibrosis through an additional correlative biomarker study (MPD-RC #107). The     correlative biomarker study is a study that is related to the main study, but is looking to     answer different questions than the main study. The purpose of the biomarker study is to     understand the causes of MPD and to develop improved methods for the diagnosis and treatment     of these diseases, while the main study is trying to find out how well CEP-701 (Lestaurtinib)     will work in treating the myeloproliferative disease.   "
215305|NCT00668434|"     Sciatica is a condition that causes a sharp, burning pain in the back, buttock, and leg. The     condition is caused by injury to or compression of the sciatic nerve, which is located in the     back of the leg. This study will determine the effectiveness of the steroid prednisone in     decreasing pain and improving function in people with sciatica.   "
215306|NCT00668447|"     The purpose of this study is to test the effect of 1 year of added dietary soy protein and/or     soy isoflavones on bone mineral density in late postmenopausal women.   "
215310|NCT00668499|"     This will be a single institution non-randomized phase I/II trial for patients with malignant     mesothelioma stage II and above, who have not received prior chemotherapy for their disease.      The purpose of this phase is to select a dose of VEGF-AS (antiangiogenesis drug)to be given     with standard doses of pemetrexed followed by cisplatin on day 1 of a 21-day cycle.   "
215311|NCT00668512|"     This is a Phase I pilot study to evaluate the toxicity of two intra-tumoral injections of GSL     alpha-GAL in patients with advanced or metastatic cutaneous melanoma. Patients who have     failed standard therapies or are not eligible for standard treatment will be eligible for     this study.   "
215312|NCT00668525|"     This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram     in adult patients (18 to 65 years of age) with moderate to severe depression. Patients     completing the study may be eligible to enter a long-term open-label extension study with     escitalopram.   "
215313|NCT00668538|"     The purpose of this study, is to study the uptake of the pharmaceutical antifungal miconazole     when used as a vaginal suppository in young women. The investigators want to know if the     uptake is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).   "
215314|NCT00668551|"     To eliminate barriers (such as travel and cost) to specialized Parkinson disease (PD) care,     two movement disorder specialists at the University of Rochester will be providing     telemedicine visits for patients with PD who reside in the Presbyterian Home for Central New     York in New Hartford, NY, or for individuals who participate in the local support group that     meets at the nursing home. Participants will attend 3 telemedicine visits at the Presbyterian     Home over the course of 6 months.      We hypothesize that this telemedicine model will in time improve access to care and hence the     quality of life and quality of care of individuals with PD.   "
215315|NCT00668564|"     The primary objective of this clinical trial is to evaluate the ability to achieve and     sustain donor engraftment in patients with lysosomal and peroxisomal inborn errors of     metabolism undergoing hematopoietic stem cell transplantation (HCT).   "
215316|NCT00668577|"     The purpose of this study is to demonstrate the absence of irritation potential (primary     dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the     product Dermacyd Pocket BR.   "
215317|NCT00668590|"     Mounting evidence documents the positive impact of using patient decision aids (PtDA) to     facilitate shared decision-making (SDM) between patients and physicians in preference     sensitive contexts. But overall use of PtDAs across the broader US healthcare system remains     low. More compelling evidence is needed to make the case for policies that would accelerate     adoption of PtDAs in routine clinical practice in primary care settings that serve diverse     and economically disadvantaged populations. The investigators believe that it is now time to     move beyond the subjective evaluations of PtDAs that are commonly reported in clinical trials     of PtDAs, to evaluate whether these tools can also change health behavior and improve health     outcomes. Therefore, the investigators will build on their expertise in working with     community-based physicians to evaluate a newly developed PtDA focused on diabetes, using a     mixed-methods approach. The investigators patient sample will be drawn from primary care     practices serving African American, Latino and Caucasian patients. The investigators will     conduct a 2-group randomized controlled trial to evaluate the effects of the diabetes PtDA,     combined with telephone coaching, in increasing patient self-care and self-efficacy,     increasing diabetes knowledge and improving clinical measures including glycosylated     hemoglobin A1c, lipids and blood pressure. The investigators will also explore variation in     effects of the patient decision aid, comparing African American, Latino and Caucasian     patients and conduct in-depth interviews with a randomly selected subset of trial     participants to explore patient perceptions of the decision aid and variation across     racial/ethnic groups. The investigators hypothesize that, compared to the control condition,     participants assigned to receiving the video PtDA program and telephone coaching will report:     greater self-efficacy and diabetes knowledge, more engagement in self-care behaviors, better     glycemic control as measured by hemoglobin A1c, as well as lower quantitative LDL and blood     pressure levels. The conceptual model guiding the investigators trial is the Integrative     Model of Behavior Change. The model includes three primary determinants of behavior:        1. attitudes toward performing the behavior        2. perceived social norms about performing the behavior        3. self-efficacy. The investigators expect the diabetes PtDA to affect each of these          constructs directly or indirectly.   "
215352|NCT00669045|"     The POST study comprised patients whose data were entered into the NRMI 4 and 5 databases.     NRMI is a prospective, observational study of patients presenting with AMI in the United     States. NRMI was launched in 1990 and to date has enrolled more than 2.5 million AMI     patients. More than 1,700 hospitals have participated in NRMI during the last 16 years. The     NRMI 4 and 5 substudies were sponsored by Genentech and collected data on approximately     160,000 AMI patients (both ST elevation and non-ST-elevation MI) hospitalized in the United     States each year. This corresponds to approximately 18% of the AMI patients in the United     States.   "
215318|NCT00668603|"     Recent large randomized, placebo-controlled studies assessing the health effects of HT     question the overall benefits of long term HT, especially with respect to cardiovascular     disease. However, recently menopausal women with severe hot flushes were mostly excluded from     these trials. This was unfortunate since vasomotor symptoms may reflect different vascular     sensitivity to estrogen or its deficiency, and therefore, the vascular responses to HT in     women with and without hot flushes can differ.      Aims of the present project are        1. to compare vascular, cardiac and sympathetic function in recently menopausal women with          or without severe vasomotor symptoms        2. in a randomized placebo controlled clinical trial investigate vascular response to oral          and trans-dermal HT.   "
215319|NCT00668616|"     The purpose of this study is to determine whether a treatment with 4 cycles anthracycline +     cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than     therapy with 4 cy<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel   "
215320|NCT00668629|"     The purpose of this study is to prove the absence of photo irritation and photo sensitivity     potential of the product Dermacyd Tina Gel Sweet Flower.   "
215321|NCT00668642|"     The purpose of this study is to determine if the drug dutasteride increases expression of     genes that slow the growth of prostate cancer during treatment with intermittent androgen     ablation therapy (hormone therapy).   "
215322|NCT00668655|"     The purpose of this study is to determine the cosmetic appearance of metronidazole gel     (MetroGel®) 1% with commonly marketed facial foundations.   "
215323|NCT00668668|"     The purpose of this study is to demonstrate the absence of irritation potential (primary     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the     product Dermacyd Tina Gel Sweet Flower.   "
215324|NCT00668681|"     This study is intended to provide data to verify safe delivery of a staple previously     intended for use in open surgical procedures. A newly modified delivery system will provide     endovascular access for implantation of a staple during endovascular graft procedures.   "
220460|NCT00730275|"     This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to     17 year old diabetic patients.   "
215325|NCT00668694|"     In developing countries, poor nutrition, high morbidity, poverty, poor parental education and     stimulation in the home, all detrimentally affect children's development. These conditions     frequently occur together increasing the risk of poor development. Iron deficiency anemia     (IDA) affects large numbers of young children and is associated with poor child development.     There is some question as to whether infants with IDA can catch up in mental development to     non-IDA infants. We plan to examine the effect of psychosocial stimulation on IDA children's     growth and development using a randomized controlled trial and compare them with non-anemic     children. The study will be located in poor villages accessible to Dhaka. Villages will be     randomized to either receive psychosocial stimulation or none. Children, aged 6-12 months,     with IDA (hemoglobin (Hb) 80.0-109g/L, ferritin<12μg/L & Transferrin Recepter (TfR) >7)     (n=212) or without anemia (Hb>109g/L, ferritin>12μg/L, C-reactive protein (CRP) <5 & TfR<7)     (n=212) will be identified in those villages. Intervention will include weekly home visits     for 9 months by a play leader, who will demonstrate play with home made toys and teach the     mothers about child development. All IDA children will be given 30 mg ferrous-sulphate daily     for 9 months. At the beginning and end of the study, the following measurements will be made:     Bayley Scales of Infant Development (mental and motor indices), Wolke's behavior ratings, Hb,     serum ferritin, CRP, Transferrin receptor, anthropometry, home stimulation, and mothers'     knowledge and practices of child development. Stool microscopy, maternal-urinary iodine (as a     proxy to assess children's iodine status), dietary history, child rearing practices     (parenting) of mothers, perinatal history and socioeconomic conditions will be assessed at     the beginning and children's language development at the end. Depending on availability of     funds serum TSH will also be measured in children to exclude iodine deficiency. We will also     measure mothers' nutritional and mental status to assess its relationship with children's     development. The treatment effect will be examined by intention to treat analysis using     multiple regression of the outcome variables controlling for initial measures and multilevel     analysis will be conducted to control for differences at village level. The findings of this     project will have implications both for international and national policies on early     childhood development programs for IDA children.   "
215326|NCT00668707|"     There is evidence to support the use of melatonin, a natural health product, as an additional     treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20     milligrams of melatonin for one year can lower the incidence of developing lung cancer     recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are     eligible for surgical resection can participate in the trial. The study will also be     assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression     amongst the participants.   "
215327|NCT00668720|"     Tinnitus is a phantom auditory perception of meaningless sound, meaning that there is     registration of sound in the absence of an external or internal acoustic stimulus. It is a     common problem (prevalence 7-19%) which may interfere with the ability to lead a normal life.     Unfortunately, it is a very difficult symptom to treat because there are hardly any     therapeutic options for the cause of tinnitus. Most therapies focus on alleviating the     condition rather than treating the cause. Tinnitus is thought to be generated in the brain,     as a result of functional reorganization of auditory neural pathways and tonotopic maps in     the central auditory system, following damage to the peripheral auditory system. Repetitive     Transcranial magnetic stimulation (rTMS) is a therapy, based on this concept of     reorganization in the auditory cortex. It uses a pulsed magnetic field to disrupt the neural     circuit and to thereby (temporarily) excite or inhibit certain brain areas, leading to the     suppression of tinnitus.   "
215328|NCT00668733|"     The objective of this study was to obtain long-term sustained clearance rates for subjects     previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and     GW01-0705.   "
215329|NCT00668746|"     This study will look at the safety of using the study medicine for a long time. It will see     if the germs get used to the medicine, making it not work as well, if it's used by people     with gum disease for a long time.   "
215330|NCT00668759|"     The primary objective of the study is to demonstrate the superiority of vernakalant injection     over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR)     within 90 minutes of the start of drug administration. The secondary objective is to compare     the safety of vernakalant to amiodarone.   "
215331|NCT00668772|"     The primary objectives of this study are to assess bronchodilator efficacy as determined by     FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as     determined bt the SGRQ and the effect on COPD exacerbations   "
215332|NCT00668785|"     This is a randomized, open-label Phase II study evaluating the safety and efficacy of     intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic     Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema.   "
215333|NCT00668798|"     Cytomegalovirus infection threatens preterm infant. We investigated, whether thawed breast     milk is a mode of transmission   "
215334|NCT00668811|"     This study is comparing a drug called Sutent with standard of care treatment for people with     advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and     effective treatment options are limited, new therapies are desperately needed.      This study is designed to see if Sutent following therapy with radioactive iodine will target     cancer cells and delay disease progression better than standard therapy alone. Newly     diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard     care are possible candidates. By entering into this study, participants agree to take oral     Sutent for approximately one year after completing standard therapy. During this time, study     participants will be followed closely by their doctor.   "
215335|NCT00668824|"     Magnetic Resonance Imaging (MRI) is an effective and radiation free method of diagnosing     Congenital Heart Disease (CHD). MRI works by taking images of the anatomy and physiology.     These images also provide information on the hearts function and blood flow. The clarity of     these images is enhanced by the use of contrast agents (dyes). However these agents only stay     in the blood vessels for a short time and therefore limit the time in which the better     quality images can be obtained. This study aims to determine whether MRI using Vasovist (a     dye that stays in the vessels for a prolonged period of time) can improve the diagnosis of     Congenital Heart Disease (CHD) by allowing more areas to be imaged and the improved     assessment of various parameters (anatomy, volumes, flow) as well as vastly improving image     quality.   "
215336|NCT00668837|"     Open-Label Extension to the double-blind effectiveness and safety study R076477-SCH-305 to     evaluate long-term safety and tolerability in patients with schizophrenia.   "
215337|NCT00668850|"     To compare the efficacy of Generex Oral-lyn™ RapidMist™ System and standard regular human     insulin therapy as measured by HbA1c, in type-1 diabetes mellitus subjects on BID NPH     intermediate acting insulin therapy.   "
215338|NCT00668863|"     To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan,     5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients   "
220999|NCT00747539|"     This study will evaluate the impact of standard hepatitis C virus treatment on brain deficits     in people who are infected with both HIV and the hepatitis C virus.   "
215339|NCT00668876|"     The purpose of this study is to determine whether immunonutrition is effective on surgical     site infection and Th1/Th2/Th17 differentiation in patients undergoing     pancreaticoduodenectomy   "
215340|NCT00668889|"     The purpose of this study is to prove the absence of photo irritation and photo sensitivity     potential of the product Dermacyd Tina Gel Tangerina Mix.   "
215341|NCT00668902|"     The purpose of this study is to determine the function of an enzyme that breaks down drugs     and helps the removal of drugs from your body. This enzyme is called cytochrome P450 2C19 and     is located in your liver. Exposure to other medications or variations in genes that you have     inherited from your parents, may speed up or slow the function of this enzyme. As a result,     some patients may develop unwanted effects from a drug while some other patients may not get     benefit from taking the same drug. The aim of this study is to determine the function of this     enzyme in your liver. We will do this by performing a series of breath tests and blood     samples after you take pantoprazole. Pantoprazole is approved as an oral and intravenous drug     by the Food and Drug Administration (FDA).   "
215342|NCT00668915|"     Total joint arthroplasty are common operations among the elderly population. The     postoperative patients' rehabilitation process may be influenced by a variety of factors,     such as age, BMI, perioperative hemoglobin levels, pain perception, comorbidities, etc.     Nevertheless, only a few well controlled studies evaluated the effect of various factors on     patients' rehabilitation short-term outcome. Furthermore, no scale has been developed, that     can predict patients' rehabilitation and functioning levels 6 weeks postoperatively. In the     current study we wish to evaluate the effect on patients' function that the following factors     have: age, BMI, admission and discharge hemoglobin levels, pain perception, type of operation     (TKA versus THA), intensity of postoperative physiotherapy, involvement of other joints by     the primary pathology, comorbidities, and self assessed health status.      In order to quantify patients' level of functioning, several tests will be used: hand grip     strength, Timed up and go test (TUG) and Oxford knee and hip score. The factors that will be     found statistically significantly associated with level of functioning, will be used in an     attempt to develop a scale that will predict the level of functioning 6 weeks     postoperatively.      Such a scale can allow preoperative identification of patients at high risk of postoperative     low functioning levels and the application of a unique rehabilitation program, for only these     patients, in order to optimize their functioning.   "
215343|NCT00668928|"     A large and growing segment of the population is prediabetic. Dietary interventions that     improve insulin sensitivity may be important in preventing the progression to full-blown     diabetes in these individuals. Foods and dietary compounds that increase insulin sensitivity     are likely to help maintain a healthier body composition. This pilot study will provide data     to evaluate the role of dietary plant polyphenols in improving insulin sensitivity.   "
215344|NCT00668941|"     Osteoporosis is a disease that affects millions of individuals in the United States and     abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study     will compare continuous versus cyclic treatment with teriparatide combined with alendronate,     another drug for osteoporosis, or teriparatide alone in women with osteoporosis.   "
215345|NCT00668954|"     This is a research study designed to look at how pomegranate juice (or a placebo juice)     affects the body through the measurement of specific biomarkers, which are indicators of     health.   "
215346|NCT00668967|"     The purpose of this study is to demonstrate bioequivalence of single doses of two verapamil     formulations   "
215347|NCT00668980|"     The aim of this study is to characterize the process of constitution of symbolic     representation in infants with Down syndrome, as well as to investigate the relationship     between gestures and the emergence of oral language. The investigators hypothesis is that     children with Down syndrome could present difficulties during the constitution of symbolic     representation that may be related to later deficits on expressive language, generally     observed in these children.   "
215348|NCT00668993|"     This pilot study will examine one issue only in weight loss - food cravings in overweight     (i.e. BMI between 25-29.9) or obese (BMI greater than 30) consumers. Food craving is     hypothesized to be an important intervening causal variable and the development of obesity.      This randomized clinical trial will explore whether a relatively under researched energy     based therapeutic procedure, Emotional Freedom Techniques (EFT), can reduce food cravings in     participants under laboratory-controlled conditions, and compare this to a waitlist group.     The following foods will be tested: chocolate, salty foods (e.g. chips, crisps, salted nuts),     sweet carbohydrate foods (eg. cakes, biscuits, soft/soda drinks), carbohydrate foods which     are neither sweet nor salty such as white refined foods such as bread), and caffeinated     items.      Research examining energy based procedures (e.g. EFT) combines cognitive strategies with     somatic procedures adapted from acupuncture and related systems for altering the cognitive,     behavioural, and neurochemical foundations of psychological problems. It is often referred to     as psychological acupuncture. Few adequately controlled studies have been conducted on EFT     however acupuncture has been quite extensively studied, with hundreds of research reports     published (see attached references).      Screening will occur over the telephone with one of the chosen self report questionnaires -     the Food Craving Inventory (FCI; White et al., 2002). The FCI is a reliable and valid measure     for the assessment of cravings for specific types of foods: High Fats, Sweets,     Carbohydrates/Starches, and Fast Food Fats, all of which comprise the higher order construct     of food craving or the FCI Total score (White et al., 2002). Higher numbers for each of the     subscales reflect greater cravings for that food type with the highest score being 185.     Scores of 93 or higher during the screen will be used to admit subjects to the next     diagnostic interview phase of the trial. In addition, subjects will be asked their weight and     height in order to ascertain their BMI and this will be confirmed in the diagnostic interview     with a standardized weight machine.      The Structured Clinical Interview (SCID-II; Spitzer, Williams, Gibbon, & First, 1990) has 12     groups of questions corresponding to12 personality disorders and will be used as a diagnostic     tool in a face-to-face interview with subjects who are suitable from the telephone screen.     The aim is to exclude any active diagnoses from the DSM-IV in order to obtain the purest non     clinic sample possible. All subjects will be notified by letter of the outcome of their     diagnostic interview and those unsuitable for the trial will be told they did not meet     selection criteria. Suitable practitioners who would be able to provide individual support     for the food cravings will be provided in written format. Subjects who meet a diagnostic     category will be informed of this and appropriate referral will be offered.      Participants will be randomly assigned (using the NHMRC Clinical Trials Centre service) to a     free group EFT treatment condition or a non treatment waitlist control condition of the same     duration (4 weeks). This design ensures that potential treatment gains are neither due to the     mere passage of time nor regression to the mean. To limit attrition from waitlist conditions,     several contacts will be made with the waiting clients. Prescheduled phone contacts, for     example, may maintain adherence to the waitlist condition.      Prior to treatment all subjects will be weighed and height measured for their BMI status and     food craving outcome measures (pre, post and follow-up) will be measured using:        1. SUDS rating (subjective) in daily food diaries (food diaries were chosen as a method          that best measures real-life eating behaviour)        2. Power of Food Scale (Didie, 2003)        3. Food Craving Inventory (White et al., 2002)      Three aspects of eating behaviour will be measured using the Revised Restraint Scale (Herman     & Polivy, 1980). The items are summed for a total score that ranges from 0 to 40. High scores     indicate chronic dieting in which the individual is constantly cycling on and off the diet,     typically without any substantial weight loss. Dietary restraint appears to play a causal     role in the development of eating disorders and obesity and loss of control over intake. Food     cravings may trigger these eating behaviours.      The Symptom Assessment 45 (SA-45, Strategic Advantage, 1998) will be used to assess     symptomatology across nine psychiatric domains and as measures of the outcome of the     psychological intervention.      Demographic information will be collected in questionnaire format at the beginning of the     study.      The EFT intervention will consist of 4 sessions (2 hours duration) with homework and will be     based on standard delivery of EFT, as per founder Gary Craig's training for level 1 EFT     certification ( see http://www.emofree.com/WorkShop/workshop-guidelines.htm#Level%201).   "
215349|NCT00669006|"     To establish the infrastructure for a national neuropathic pain database.      To determine the longterm outcome of the management of chronic neuropathic pain including     pain relief, disability, and quality of life.   "
249289|NCT01119027|"     The purpose of this study is to improve the investigators understanding of different training     methods in laparoscopic colon surgery.   "
215353|NCT00669058|"     The purpose of this study is to demonstrate the absence of irritation potential (primary     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the     product Dermacyd Tina Gel Tangerina Mix   "
215354|NCT00669071|"     This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide     0.01%, hydroquinone 4%, tretinoin 0.05%) when used sequentially with a series of intense     pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a     10 week treatment period.   "
215355|NCT00669084|"     This study, sponsored by NIAID and the University of Bamako, Mali, will identify genetic and     other factors that may protect against severe malaria in some children.      Children between 6 months and 17 years of age who live in Kenieroba, Fourda or Bozokin     villages in Mali may enroll in the study. Participants have a blood sample collected by     finger prick with a small needle. The blood is examined for gene variants that influence the     severity of disease in children exposed to the malaria parasite.      Children who develop a fever or other symptoms of malaria are evaluated and treated in     Kenieroba s health center for up to 5 years from entering the study, or until they reach 18     years of age. The children are treated with artesunate and amodiaquine. Children with severe     disease are treated with quinine. One tablespoon of blood is drawn from the children for     study.      At the end of the dry season and the wet season, a subset of 200 healthy children are asked     to provide 1 or 2 tablespoons of blood, drawn through a needle placed in a vein in the arm.     Additional research blood samples may be requested from children between 2 and 17 years old.     Blood will not be taken from any child more than twice a year.   "
215356|NCT00669097|"     This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of     TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg     dose of TKI258 followed after 15 days by daily dosing of 400mg TKI258. Cohort 2 (9 patients)     will receive 400mg TKI258.   "
215357|NCT00669110|"     The primary purpose of this study is to evaluate the long-term safety and tolerability of     Desvenlafaxine Succinate Sustained-Release (DVS SR) in child and adolescent outpatients with     major depressive disorder. A secondary aim is to evaluate the efficacy of DVS SR in the     treatment of child and adolescent outpatients with major depressive disorder in an     exploratory manner.   "
215358|NCT00669123|"     The purpouse of this study is to determine the efficacy and safety of chondroitin sulphate     conventional treatment in patients with both knee osteoarthritis and plaque psoriasis.   "
215359|NCT00669136|"     To evaluate the safety, toxicity and immunological effects of adjuvant administration of an     experimental therapy consisting on priming with three intramuscular administrations of a     plasmid expressing human AFP (phAFP) together with a plasmid expressing human GM-CSF     (phGM-CSF), followed by a single intramuscular boost with an AFP adenoviral vector (AdVhAFP)     to patients with locoregionally pre-treated hepatocellular carcinoma (HCC).   "
215360|NCT00669149|"     The purpose of this study is to determine whether adjunction of intravenous anticoagulant     therapy (enoxaparin, HNF, bivalirudin) to antiaggregation with clopidogrel and aspirin     improves in-hospital results of percutaneous transluminal coronary angioplasty (ptca) in     selected patients.   "
215361|NCT00669162|"     Following a radical prostatectomy and lymph node sampling, eligible patients will undergo     post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal     therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3     months for 2 times).   "
215362|NCT00669175|"     When narcotic pain medicine, like fentanyl or morphine, is given to adults and children for     several days, they often develop a tolerance to the medicine. This means they may need higher     doses over time to get the same amount of pain control. When it is time to stop the medicine,     the dose has to be decreased slowly so that the patient does not have withdrawal symptoms.      Naloxone is a medicine that at high doses can reverse the effects of narcotics. At very small     doses it may help prevent tolerance and lessen the severity of withdrawal symptoms. This     could mean less narcotic pain medicine is needed over fewer days.      The purpose of this research study is to see if giving naloxone to neonates who require     narcotic infusions is safe and effective. Safety will be measured by the incidence of side     effects. Efficacy will be measured by monitoring for changes in pain and sedation scores and     need for more pain medicine.   "
215363|NCT00669188|"     This study will investigate factors surrounding use and application of scientific literature     in patient-provider interactions and will examine facets of the patient-provider interaction     itself as studied in a virtual encounter using virtual reality.      Healthy third- or fourth-year medical students or first-year medical interns in internal     medicine and family practice specialties may be eligible for this study. Participants are     recruited from the Washington, D.C., area.      Study subjects perform two tasks and complete two sets of questions. The first task involves     reading scientific content on a health topic of public interest and explaining the article as     if to a patient. The second task involves interacting with a virtual patient in a virtual     environment clinical scenario. While in the virtual environment, the subject wears a     head-mounted video unit that allows him or her to see elements of the environment. The     activities in the virtual environment take about 15 minutes. The total time for the study is     about 60 minutes.   "
215364|NCT00669201|"     Purpose:Evaluate the feasibility of T2 cartilage mapping on MRI of the wrist and correlate     with T2 mapping of knee cartilage.      Study protocol: Phase 1. 10 healthy volunteers, Phase 2. 10 volunteers with osteoarthritis of     the wrist, Phase 3. 50 patients for studies for routine MR of the wrist.      MRI protocol: 3 T unit((Signa EXITE HDx),T1, T2 and T2 mapping sequences on axial and coronal     orientation.   "
215365|NCT00669214|"     This was a Phase IV randomized, double-blind, placebo-controlled study designed to evaluate     the safety and efficacy of subcutaneous efalizumab in adult patients (18 years of age and     older) with chronic moderate to severe plaque psoriasis with involvement of the scalp who had     no previous exposure to efalizumab. The study consisted of a screening period, a double-blind     treatment period, an open-label treatment period, and an observation/follow-up period. The     study enrolled 100 patients. 11 patients were excluded from all analyses because of data     issues.   "
215390|NCT00669539|"     This study will evaluate the effectiveness of refractive correction alone for the treatment     of previously untreated strabismic or combined-mechanism amblyopia in children 3 to <7 years     old with visual acuity of 20/40 to 20/400   "
215366|NCT00669227|"     Autologous stem cells may improve myocardial regeneration after intracoronary administration     in patients with acute myocardial infarction. The primary hypothesis of this prospective,     placebo-controlled, double-blind trial is that the increase of ejection fraction determined     by magnetic resonance imaging between baseline and 6 months follow-up is superior in active     treated patients compared to patients receiving placebo. The study includes an integrated     pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by     cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size     will be calculated. The primary endpoint is the improvement in left ventricular ejection     fraction with an assumed 2.5% higher improvement in the cell treated population compared to     the placebo treated group.   "
215367|NCT00669240|"     The purpose of this study is to determine the safety and efficacy of varenicline in the     real-world environment of smokers attending primary care in routine clinical practice with     the addition of being offered behavioral support Life REWARDSTM. This is a     non-interventional study.   "
215368|NCT00669253|"     Conventional non-surgical periodontal treatment, that is, root debridement using manual and     ultrasonic means at baseline and surgery using the same means after 6 months in case of     persistent deep pockets (Group 1)/ Er:YAG laser used in a non-surgical approach at baseline     and surgery using the same laser after 6 months in case of persistent deep pockets (Group 2)/     Surgery at baseline using manual and ultrasonic means (Group 3). All patients will undergo     supragingival maintenance on a yearly basis.   "
215369|NCT00669266|"     The pathogenesis of adrenal tumors is still not fully elucidated and the treatment options     for malignant tumors are poor. The current study investigates different aspects of the     pathogenesis of adrenal tumors and evaluates different therapeutic options in patients with     adrenocortical carcinoma.   "
215370|NCT00669279|"     The purpose of this research study is to determine whether atenolol or controlled release     carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure     measured in the aorta, a large blood vessel carrying blood away from the heart, may be a     better measure of the harmful effects of high blood pressure on the body's organs. In the     past, blood pressure has only been measured in the arms. However, blood pressure in the arms     may not accurately reflect the blood pressure in the aorta and thus may mislead doctors     treating high blood pressure. For this reason, we are testing whether two different     medications for blood pressure, both in a class called beta blockers, have similar effects on     blood pressure in the arm and aorta.   "
215371|NCT00669292|"     This is a single institution phase I / II trial to evaluate the safety and efficacy of     URLC10-177 and TTK-567 emulsified with Montanide ISA 51 in combination with different doses     of CpG7909 in patients with advanced or recurrent esophageal cancer.   "
215372|NCT00669305|"     Human participants affected with sickle cell disease or thalassemia will donate bone marrow     for use in experimental laboratory models to study potential new treatments. This is an     observational study using bone marrow from human participants. The investigators will use     sickle cell and thalassemia mouse models to observe and evaluate the possibility of     correcting these disorders through genetic alterations or drug treatment.   "
215373|NCT00669318|"     RATIONALE: Drugs used in chemotherapy, such as pentostatin, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Giving pentostatin     together with alemtuzumab and rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving pentostatin together with     alemtuzumab and rituximab works in treating patients with relapsed or refractory chronic     lymphocytic leukemia or small lymphocytic lymphoma.   "
215374|NCT00669331|"     No gold standard therapy exists for clearing mucus from the airways of patients with     bronchiectasis. While rhDNase has a proven place in the treatment of cystic fibrosis (CF), it     failed to improve Forced expiratory volume in one second (FEV1) in a short-term non-CF     bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF     bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline     has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be     examined as a long term treatment option in bronchiectasis.      The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with     inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with     inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration;     improvement in quality of life and respiratory symptoms in patients with bronchiectasis and     pulmonary function in cystic fibrosis. The results of this current study in combination with     a recently completed 3 month study seek to confirm these early findings and to extend the     evidence to support its use as a mucoactive therapy in subjects with bronchiectasis.      We hypothesize that mannitol will improve the overall health and hygiene of the lung through     regular and effective clearing of the mucus load. As a consequence of the reduction in mucus     load and inflammatory process, the frequency of bronchiectasis related pulmonary     exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in     hospital and community health care costs are expected to change in line with improvements in     respiratory health.      Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52     week period. We will test these hypotheses using 400 mg mannitol twice daily (BD) against     control.   "
215375|NCT00669344|"     The study is a 24-week prospective, double blind, randomized, placebo-controlled pilot study     of 9 mg / day Rivastigmine in patients with Vascular Cognitive Impairment Not Dementia (CIND)     to evaluate efficacy, safety and tolerability in Asian patients. The hypothesis is that     patients receiving Rivastigmine would improve in executive functioning domains.   "
215376|NCT00669357|"     Abiocor is a post market approval study for an Implantable Replacement Heart. This post     approval study is currently on hold.   "
215377|NCT00669370|"     To determine the quality of life in patients with gastric cancer who receive combination     treatment with docetaxel and capecitabine. Secondary endpoints are time to progression,     overall response rate and overall survival.      Study treatment will continue until disease progression or unacceptable toxicity.   "
215391|NCT00669552|"     T-wave alternans is a test that looks at microvolt changes in the T-wave on a beat to beat     basis. The presence or absence of such changes has been shown to predict or exclude future     arrhythmic events. The mechanism of T-wave alternans is unclear, but may relate to calcium     metabolism in the heart, and may be affected by conditions such as ischemia or heart failure.      The purpose of this study is to determine whether T-wave alternans, as measured through the     lead of an implantable defibrillator, is produced by acute ischemia induced by occlusion     during percutaneous coronary interventions.   "
249578|NCT01122953|"     To investigate the bioequivalence between two compounds (phenytoin and epamin) by a     randomized, single dose study under fasting conditions in healthy volunteers.   "
215378|NCT00669383|"     One course of steroids given to a mother before a premature delivery helps the lungs of the     premature infant and decreases breathing problems. One course of antenatal steroids is the     standard of care for threatened premature deliveries. It is unclear as to how long the     benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if     the steroids are given at least 24 hours before but within 7 days of a premature delivery. It     is difficult to predict the timing of a preterm delivery so deliveries often do not occur     within this time period. We hypothesize that the benefits of the steroids to the lungs wear     off if the steroids are given more than 14 days before a preterm delivery, and that in these     circumstances an extra course of steroids will help the premature baby's lungs and the     premature baby will have less breathing problems as shown by lung function testing.   "
215379|NCT00669396|"     The purpose of this study is to see if women presenting for emergency contraception (EC) are     willing to accept the copper intrauterine device (IUD). This study will also compare the use     of effective methods of contraception between women who selected the copper IUD or Plan B 6     months after they received EC.   "
215380|NCT00669409|"     To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese     patients with moderate to severe pain from OA of the knee (Part I). To evaluate the     preliminary analgesic efficacy of PF-04383119 in Japanese patients with moderate to severe     pain from OA of the knee in comparison with placebo (Part I and Part II).   "
215381|NCT00669422|"     This study will collect patient demographic, oncology history, and physician reported outcome     information following the initial round of chemotherapy received after a commercial ChemoFx®     Final Report for the generation of hypotheses of potential patient cohorts for further     sub-studies.   "
215382|NCT00669435|"     Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes     secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin,     resistin and adiponectin; these proteins have a wide range of biological effects and are     associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin     II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or     obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker     (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the     antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be     added to both groups. The aim of this study is to evaluate the effect of losartan and     simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or     obese hypertensive normocholesterolemic patients with hepatic steatosis.   "
215383|NCT00669448|"     OBJECTIVES      The objective is to evaluate the effect of an 8-week mindfulness-based cognitive therapy     (MBCT) programme on psychological - and somatic symptoms, and illness perceptions in     individuals with self- reported multiple chemical sensitivities.      PARTICIPANTS      Participants will be recruited among respondents to a survey on the consequences of     self-reported symptoms related to inhalation of airborne chemicals conducted by the Danish     Research Centre for Chemical Sensitivities.      DESIGN      The pilot trial is designed as a randomized trial on the effect of MBCT versus treatment as     usual.      INTERVENTION      The MBCT programme includes 2½ hours of group training at the Psychiatric Centre,     Rigshospitalet once a week for 8 weeks. Furthermore participants are encouraged to practice     at home for up to 45 min per day, 6 days a week during the entire course.      OUTCOME MEASURES      Effect of MBCT will be estimated from individual scores on psychometric scales   "
215384|NCT00669461|"     Delayed colonic transient time secondary to a multi-degenerative process is the most likely     cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to     accelerate colonic transit time in healthy volunteers in addition to activating the chloride     channels in the intestinal cells, it has the potential to improve constipation in patients     with PD with no subsequent adverse events on the control of the neurological manifestation of     PD. So we hypothesize the following:        1. Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients          with PD induced constipation compared to baseline.(primary)        2. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week,          compared to baseline. (secondary)        3. Lubiprostone will improve health related quality of life in subjects with PD induced          constipation. ( secondary)   "
215385|NCT00669474|"     Part 1: patients with essential hyperhidrosis are treated one time with suction curettage in     both axillae.      Part 2: patients with axillary hyperhidrosis receive one treatment with suction curettage in     one axilla, and at the same time one treatment with BOTOX injections in the other axilla.   "
215386|NCT00669487|"     This protocol aims to determine the risk/benefits of this policy by comparing head-to-head a     regimen of GPO-VIR Z or TDF/FTC/NVP for 18 months in ARV-naïve patients to a 6-month lead in     with GPO-VIR S followed by 12 months of GPO-VIR Z. The primary outcomes to be assessed will     be anemia, neuropathy, lipoatrophy and renal function.   "
215387|NCT00669500|"     Primary Aim # 1: Determine the willingness of the public to participate in an intervention     trial - NutritionQuest's Alive!TM - available in a public forum.      Aim #1 Hypotheses: Less than 10% of individuals visiting the NutritionWeek site will register     to participate in the Alive!TM Intervention; 70% of these individuals will complete the full     intervention.      Primary Aim # 2: To determine among individuals enrolled in the Alive!TM intervention,     changes in measurements of body composition from pre- to post-intervention.      Aim #2 Hypotheses: Participation in Alive!TM will result in positive changes in body     composition, including reduction of body weight, percent body fat and blood LDL and an     increase in blood HDL cholesterol.      Purposes:        1. Educate the public on the relationship between diet, weight and chronic disease        2. Collect data for future research        3. For participants of the Oregon Museum of Science and Industry (OMSI) portion of this          study, we also provide a diet assessment and optional 3-month intervention      Recruitment:      Researchers will have a display at OMSI coincidental with the Body Worlds 3 exhibit and at     local health fairs. Participants will be recruited from the attendees of the OMSI Body Worlds     3 exhibit as well as general OMSI visitors from July through October 2007 and from health     fairs at later dates.      Subject procedures:      No identifiable information will be collected; only gender, year of birth, race and ethnicity     are collected on any participant.      Subjects under age 18 can participate in any or all of the following: a brief online,     touch-screen assessment of eating and physical activity (health screening for immediate,     printed feedback), physiologic measurements (height, weight, hip and waist circumference,     percent body fat, blood pressure).      Subjects who are age 18 and over can participate in any or all of the following: a brief     online, touch-screen assessment of eating and physical activity (health screening for     immediate, printed feedback), physiologic measurements (height, weight, hip and waist     circumference, percent body fat, blood pressure), finger prick to assess blood glucose and     lipid levels as well as DNA sample (mouthwash swish).      For participants of the OMSI portion of this study, adults may also choose to join a 3-month     online lifestyle intervention (Alive!™). Participants who enroll in the 3-month intervention     will receive 12 intervention messages over a 3-month period. Each of the messages will take     about 5 to 10 minutes to read. At the end of this 3-month period, participants will receive a     post-assessment health screening at the Oregon Health & Science University (OHSU) Clinical     and Translational Research Center. This post-assessment will include completion of a diet and     physical activity assessment, fasting blood measures of glucose and lipids, blood pressure,     weight and height.      All visitors to the display area and all research subjects will be offered educational     materials.      Instruments used, for OMSI participants only:      The Alive!TM lifestyle intervention is a web-based diet assessment program designed to help     individuals evaluate their diet and make healthy changes via tailored e-mail correspondence.     This program is operated by NutritionQuest out of Berkeley, California; utilizing the Block     questionnaires, designed and validated over many years by Dr. Gladys Block, and now in use by     researchers and health practitioners world-wide.      Data analysis:      De-identified data will be stored for future analyses and will be used in descriptive     analyses to provide information on the distribution of body size variables and how they     relate to reported dietary intake. DNA data from cheek cell samples will be linked by     identification number to dietary intake and physiologic measures. Though de-identified, this     data may still be used to identify genetic profiles of individuals with various physiologic     parameters.      For OMSI participants only:      Alive!TM lifestyle intervention data will be used to determine predictors of change in     physiologic and reported intake measures pre and post-intervention, using analysis of     variance. At the time of analyses ALL data (including Alive!TM participant data) will be     de-identified.   "
215388|NCT00669513|"     Background: Sleep curtailment is common and is associated with increased mortality due to     cardiovascular causes. However, the mechanisms are not completely understood.We hypothesized     that partial sleep deprivation caused however significant changes in sympathetic activity and     endothelial function in healthy volunteers.      Methods: Thirteen young healthy male volunteers will be monitored during 12 days by sleep     diary and wrist actigraphy. The subjects will keep under their usual daily activities and     randomized to 5 nights of prolonged sleep (control) or partial sleep deprivation, interposed     by 2 nights of unrestricted sleep (wash out). At the end of each period, the subjects will be     evaluate by: 1. electrocardiogram and beat-to-beat blood pressure with spectral analysis of     heart rate and blood pressure in the supine position and after head up tilt test maneuver; 2.     resting plasma norepinephrine; 3. venous endothelial function (dorsal hand vein technique).   "
215389|NCT00669526|"     This project assesses the clinical and cost effectiveness of brief cognitive-behavioral     therapy (CBT) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in     pediatric primary care. This study is designed to compare the impact of brief CBT delivered     on-site in pediatric primary care to referral to specialty mental health care (SMHC), as well     as obtain an estimate of the total costs of the CBT protocols for depression and anxiety and     the cost-effectiveness of the protocols compared to referral to and utilization of SMHC     services.   "
215392|NCT00669565|"     This is a phase II, multicenter, single-arm, open-label safety and efficacy study of     bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced     or metastatic breast cancer.   "
215393|NCT00669578|"     RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in     different ways and stop cancer cells from growing. CC-4047 may also stop the growth of cancer     cells by blocking blood flow to the cancer.      PURPOSE: This trial is studying the side effects and best dose of CC-4047 and to see how well     it works in treating patients with myelofibrosis.   "
215394|NCT00669591|"     The purpose of the study is to determine the overall response to a combination of bavituximab     and docetaxel in patients with advanced breast cancer   "
215395|NCT00669604|"     Prevention of HIV-1 transmission from mother-to-child by non-breast-feeding is complicated by     increased infant mortality in developing countries. However, extensive counselling about     formula feeding turned out safe in Vietnam, a middle-income country.Extensive counselling     together with formula feeding and antiretroviral therapy reduced vertical transmission of     HIV-1 considerably.   "
215396|NCT00669617|"     This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to     placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg   "
215397|NCT00669630|"     This study will train Lay Health Promoters (LHPs) from African-American churches to     administer healthy living lessons and activities to their congregations in order to improve     overall health and address cardiovascular disease. The primary hypothesis is that LHP     training combined with a well supported maintenance strategy will be more effective than LHP     training alone in reducing risk factors for cardiovascular disease.   "
215398|NCT00669643|"     The purpose of this randomized trial is to verify if leprosy patients, despite of their     classification, can be treated with the same regimen without compromising patient cure and     acceptability of the treatment. At present, patients classified as multibacillary leprosy are     treated for 12 months with three drugs, and patients classified as paucibacillary leprosy are     treated for 6 months with two drugs. The study is going to test a unified regimen for     paucibacillary and multibacillary patients by treating leprosy patients with three drugs for     6 doses.   "
215399|NCT00669656|"     This study is about Prostate Health Cocktail, a combination supplement that contains vitamin     D3, vitamin E, selenium, green tea extract, saw palmetto, lycopene, and soy derivatives. This     product is currently available on the market, as herb and vitamin supplements are not     regulated by the FDA. Each ingredient has been studied in prostate cancer cells and/or in     patients with prostate cancer. At the doses included in this supplement, no serious side     effects have been reported.      The purpose of this study is to find out whether Prostate Health Cocktail can lower your PSA.     Additionally, we will be looking to see whether taking this treatment causes any unexpected     side effects, and whether certain blood tests can inform us about your disease status in     addition to your PSA   "
215400|NCT00669669|"     This phase I/II trial studies the side effects and best dose of temozolomide when given     together with radiation therapy, carmustine, O6-benzylguanine, and patients' own stem cell     (autologous) transplant in treating patients with newly diagnosed glioblastoma multiforme or     gliosarcoma. Giving chemotherapy, such as temozolomide, carmustine, and O6-benzylguanine, and     radiation therapy before a peripheral stem cell transplant stops the growth of cancer cells     by stopping them from dividing or killing them. Giving colony-stimulating factors, such as     filgrastim or plerixafor, and certain chemotherapy drugs, helps stem cells move from the bone     marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is     then given to prepare the bone marrow for the stem cell transplant. The stem cells are then     returned to the patient to replace the blood-forming cells that were destroyed by the     chemotherapy and radiation therapy.   "
215401|NCT00669682|"     T-wave alternans is a test that is currently being used to risk stratify patients with     structural heart disease for sudden cardiac death. The mechanism of T-wave alternans is     unclear, but may share a common abnormality with conditions of cardiac fluid overload such as     heart failure, which is altered intracellular calcium handling. Current Medtronic implantable     defibrillators have the capability of monitoring cardiac fluid status via transthoracic     impedance measurements.      The purpose of this study is to determine if a correlation exists between T-wave alternans     status and cardiac volume status, as determined by transthoracic impedance measurements.     Secondarily, the study seeks to examine the relationship between arrhythmia frequency and     T-wave alternans or cardiac volume status.   "
215402|NCT00669695|"     The aim of this clinical trial is to evaluate the effect of Atorvastatin on the endothelial     function improvement during the obstructive sleep apnea syndrome (OSAS) after 3 months of     treatment, by a double-blind, randomized, placebo-controlled, multi-center study.      An interim analysis will be performed when 25 patients per group will be included.   "
215403|NCT00669708|"     Dry skin is a physiological condition and is characterized in contrast to greasy skin by     roughness, desquamation and lack of brightness of the skin surface. Subjectively, feelings of     tension, burning and itching can occur. The skin reacts more intensive on external and     physical noxae. Dry skin is caused by a lack of moisture. This is most common during the     winter months, when heating systems dry the air. Bathing with hot water, spending extended     periods of time in the hot sun, and the skin's natural aging process also remove moisture and     oils from the skin. It is diagnosed through clinical observation. People suffering from dry     skin often desire to improve this condition for optical cosmetic reasons and due to the     occasional feeling of tension. The aim of this investigation is to observe the improvement     (or not) of dry itchy skin by a lotion containing a cooling compound   "
215404|NCT00669721|"     A randomised, prospective, cross over study will be done to determine whether the     anticoagulation therapy with UFH or LMWH used for hemodialysis sessions modifies     osteoprotegerin and RANKL plasma levels.   "
215405|NCT00669734|"     This phase I trial studies the side effects and best dose of vaccine therapy when given     together with sargramostim in treating patients with locally advanced or metastatic     pancreatic cancer that cannot be removed by surgery. Vaccines made from a gene-modified virus     may help the body build an effective immune response to kill tumor cells. Colony-stimulating     factors, such as sargramostim, may increase the number of immune cells found in bone marrow     or peripheral blood. Giving vaccine therapy directly into the tumor together with     sargramostim may cause a stronger immune response and kill more tumor cells.   "
215406|NCT00669747|"     The primary objective of this study is to compare the safety of 100 mg carboplatin     administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal     carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15     intraductal infusion. Secondary objectives are to characterize the biologic and clinical     effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram,     histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.   "
215420|NCT00669929|"     The primary objective of the proposed project is to estimate the economic impact of a     national rotavirus immunization program in preventing rotavirus diarrhea among Korean     children.   "
215421|NCT00669942|"     Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a     single dose (intravenous infusion) in patients with active rheumatoid arthritis in     combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.   "
215422|NCT00669955|"     This study aims at evaluating efficacy and safety of quadruple therapy (bismuth,     metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin,     clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that     quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed     H. pylori positive status will be randomized to one of the treatments described above. At     week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm     eradication.   "
215423|NCT00669968|"     How does PET myocardial perfusion imaging involving CT angiography and measurement of     coronary flow reserve affect patient care.   "
215407|NCT00669760|"     Staphylococcus aureus is not only one of the first pathogens infecting the airways of cystic     fibrosis (CF) patients, but also a highly prevalent microorganism (>60% of all CF patients;     European and American CF registries; (4,25), which often persists for several years in the     respiratory tract of CF patients.      The purpose of this study is to dissect infection by S. aureus from colonization. Therefore,     the following non-interventional prospective, longitudinal multicenter study will be     conducted to develop the following hypothesis:      CF patients with high bacterial loads are more likely to be infected by S. aureus than     patients with low bacterial loads.      Primary endpoint: bacterial load of sputum cultures      Secondary endpoints:        -  nasal carriage        -  molecular analysis of S. aureus (Monoclonal/polyclonal)        -  serum: S. aureus-specific antibodies, S100A12, IL-8, TNF-alpha        -  sputum: S100A12, IL-8, myeloperoxidase        -  S. aureus therapy regimens        -  lung function tests: FEV1, deltaFVC , deltaMEF25        -  BMI development      Inclusion criteria: S. aureus cultures for more than 6 months within the last year, children     (>6 years) and patients, who are able to perform lung function tests Exclusion criteria: P.     aeruginosa and/or B. cepacia cultures from the specimens for more than 6 months within the     last year before recruitment or during the study period In addition to microbiological     investigations and clinical laboratory tests, the actual clinical situation will be evaluated     and reported during the study period. The results of this observational study will be used to     carefully plan a clinical interventional study. Furthermore, with the results it might be     possible to characterize a subpopulation of patients, which is at greater risk for S. aureus     infections.   "
215408|NCT00669773|"     Primary Objectives        1. Validate our previously generated tumor gene expression and proteomic profiles in this          independent sample to determine the predictive power to distinguish good from poor          clinical and pathological responders to adriamycin or docetaxel.        2. Validate our previously generated plasma proteomic profiles in this independent sample          to determine the predictive power to distinguish good from poor clinical and          pathological responders to adriamycin and docetaxel.      Secondary objectives        1. To correlate adriamycin and docetaxel pharmacokinetics with             1. Genetic polymorphisms of drug metabolizing enzymes and transporters, including               MDR-1, Cyp3A, GSTs, and the nuclear receptors.             2. Drug toxicity and tumor response.             3. Peripheral mononuclear cell gene expression profiles        2. To study ondansetron pharmacokinetics and correlate that with genetic polymorphisms.   "
215409|NCT00669786|"     A randomized controlled trial comparing the ongoing pregnancy rate (primary end-point) in 280     patients undergoing IVF/ICSI after stimulation with hp-hMG or rFSH controlled with a GnRH     antagonist. Non significant differences were observed between hp-hMG and rFSH in terms of the     ongoing pregnancy rate per started cycle (35.0% vs. 32.1%; p=0.61); R.R: 1.09 (95% CI:     0.78-1.51; Risk Difference: 2.9%). No differences were observed for implantation, clinical     pregnancy and pregnancy loss rates. Patients receiving rFSH obtained more oocytes (14.4 ± 8.1     vs. 11.3 ± 6.0; p=0.001). Estradiol was higher at the end of stimulation in the hp-hMG group,     while Progesterone was higher in patients stimulated with rFSH.   "
215410|NCT00669799|"     Chronic rhinosinusitis is a pervasive and costly disease. Recent estimates describe over 20     million Americans suffering from this diagnosis at a cost of over $4.3 billion per year.     Primary intervention consists of oral antibiotics and nasal steroid sprays. A role for     antifungal irrigation has also been proposed. Topical antibiotics are used by some     physicians, but there are few reports in the published literature describing their use and     establishing or refuting their efficacy.      Sykes in 1986 performed a randomized, prospective, double-blinded study with 50 patients     using topical nasal sprays with dexamethasone, tramazoline, and neomycin; dexamethasone and     tramazoline without antimicrobial; and placebo. Both of the treatment groups showed     improvement over placebo, but in those groups there was no significant difference in response     rates between those patients receiving neomycin and those who did not. There were no adverse     events reported. In the same year, Cuenant et al. reported success with neomycin-tixocortol     irrigations in the treatment of chronic rhinosinusitis.      Scheinberg and Otsuji and Vaughn and Carvalho describe their use of various nebulized     antimicrobials (including aminoglycosides) in patients with recurrent sinusitis. Both are     uncontrolled, retrospective studies showing improvement in symptom scores. Neither study     reported any major side effects. Leonard and Bolger describe a case report and review their     success with the use of topical Ceftazidime in 50 patients. Only one patient reported     stinging sensation during administration. They reported no problems with antibiotic     resistance.      Studies by Davidson et al. , and Moss and King describe the use of topical antibiotics for     sinusitis in patients with cystic fibrosis. They report improvement in sinusitis symptoms and     reduction of need for revision sinus surgery in patients treated with surgery followed by     topical intranasal tobramycin. They report no significant side effects.      Dudley described the use of topical gentamicin in a case report of a patient with atrophic     rhinitis. The patient had resolution of her complaints without any adverse symptoms. He also     describes a study by Thornell showing success with streptomycin nasal sprays and reports work     by Rubinstein demonstrating safe administration of gentamicin into the nose without     absorption by the nasal mucosa.      On balance, the literature describes topical antibiotics as a safe, but variably efficacious     treatment for chronic rhinosinusitis. There is a paucity of prospective, randomized, blinded,     and controlled studies. The purpose of this protocol is to describe a scientifically rigorous     study of the use of broad spectrum antibiotic nasal sprays for chronic sinusitis.      The patient population for this study will consist of patients who have a history of multiple     sinus infections each year that require treatment with antibiotics. The patients in this     study will have had recurrent infections despite prior medical and surgical intervention.     They will fulfill the criteria for chronic rhinosinusitis without nasal polyposis.      Treatment will include conventional treatment with oral antibiotics and a topical nasal     steroid. In addition, patients will be randomized to receive either topical antibiotics or a     vehicle placebo. The study will follow patients for a three month period.      Patients will be monitored for improvement in radiographic findings and quality of life when     compared to a randomized and double-blinded placebo group. The patient population identified     for inclusion in this study will also be evaluated for allergy and humoral and innate     immunodeficiency. Nasal lavage will be obtained from the study population and pre and     post-treatment comparisons will be performed.   "
215411|NCT00669812|"     RATIONALE: Giving chemotherapy before a peripheral blood stem cell transplant stops the     growth of cancer cells by stopping them from dividing or by killing them. After treatment,     stem cells are collected from the patient's blood and stored. More chemotherapy is given to     prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the     patient to replace the blood-forming cells that were destroyed by the chemotherapy.      PURPOSE: This phase II trial is studying high-dose chemotherapy given together with     peripheral blood stem cell transplant in treating patients with intestinal T-cell lymphoma.   "
215412|NCT00669825|"     ALV003-0812 is a study of the safety and tolerability of a study drug (ALV003) in healthy     adult volunteers and in patients with well-controlled celiac disease, following a meal that     contains gluten.   "
215413|NCT00669838|"     Prospective, randomized double-blinded study to investigate hemodynamic changes in valvular     cardiac patients during dental treatment with the use of a local anesthesia containing     epinephrine.   "
215414|NCT00669851|"     This study evaluated and optimized settings for, and evaluated the performance of,     AI-700-enhanced echocardiographic imaging on several ultrasound imaging platforms, as well as     collected additional safety data for AI-700 in healthy volunteers and stable cardiac     patients.   "
215415|NCT00669864|"     This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose     control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese     subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.   "
215416|NCT00669877|"     The goal of this clinical research study is to learn if intensive chemotherapy given over 6     months can help to control or cure Burkitt's leukemia, Burkitt's lymphoma, or small     non-cleaved cell B-cell leukemia or lymphoma. Another goal is to see how well this treatment     works when given with Rituximab. The safety of the combined treatment will also be studied.   "
215417|NCT00669890|"     The addition of gemtuzumab ozogamicin (GO) in combination with Busulfan/Cyclophosphamide     followed by AlloSCT in patients with high risk CD33+ AML/JMML/MDS will be safe and well     tolerated.      This study will attempt to determine the maximum tolerated dose of the immune therapy     (gemtuzumab) when given in combination with the myeloablative (high dose) drugs used in this     study for allogeneic stem cell transplant. (Part A)   "
215418|NCT00669903|"     This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of     multiple ascending doses of AZD0328 in patients with schizophrenia   "
215474|NCT00664261|"     RATIONALE: The Clinical Effort Against Secondhand Smoke (CEASE) program may be more effective     than standard care in increasing the number of parents who stop smoking.      PURPOSE: This randomized clinical trial is studying how well the CEASE program works compared     with standard care in helping parents stop smoking.   "
215419|NCT00669916|"     This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study     comparing 3 mg/kg of AIN457 to placebo. Subjects with a diagnosis of moderate to severe     stable plaque psoriasis will be randomized to receive either AIN457 or placebo. AIN457 or     placebo will be administered by single infusion at baseline and subjects will be observed for     up to 26 weeks following the infusion.   "
215424|NCT00669981|"     This study will evaluate the effectiveness of cognitive behavioral couples therapy designed     for post-traumatic stress disorder in reducing symptoms of post-traumatic stress disorder and     in improving relationship functioning.   "
215425|NCT00663611|"     Background:      - In elderly individuals, an age-associated decline in the immune system s ability to     function is believed to contribute to increased incidence of infection, autoimmune disorders,     and cancer. This decline in immune system function may be related to the decline in the body     s production of growth hormone, which helps regulate human development and may contribute to     the health of the immune system. Researchers are interested in studying whether growth     hormone, given as an infusion over time, can improve the function of the immune system and     other body systems associated with good health.      Objectives:      - To study the effects of growth hormone administration on the immune systems of healthy men.      Eligibility:      - Healthy men between 25 and 50 years of age.      Design:        -  This protocol will involve three separate studies: Study I, Study IB, and Study II.          Participants in Study I and Study IB may participate in Study II as directed by the          researchers.        -  Participants will be screened with a full medical history and physical examination, and          will provide blood, urine, and stool samples; have a glucose tolerance test; and have          other tests as required by the researchers.        -  Participants will have an infusion pump with a small catheter inserted beneath the skin          to administer the study chemicals (either growth hormone or placebo).        -  Study I and Study IB participants will receive pulses of growth hormone through the          infusion pump at regular intervals to monitor the body s response to the hormone. Study          IB participants will receive a higher dose of growth hormone than Study I participants.        -  Throughout the study period, all participants will have frequent blood and urine tests,          as well as tests of glucose tolerance and metabolism, imaging studies, and other tests          as required by the researchers.        -  Study II participants will be divided into two groups. The first group will receive          pulses of either growth hormone or placebo infusion at intervals throughout the day for          4 weeks, followed by an 8-week period without infusions. The second group will receive          conventional once-a-day infusion of growth hormone or placebo for 4 weeks, followed by          an 8-week period without infusions.        -  Throughout the study period, all participants will have frequent blood and urine tests,          as well as tests of glucose tolerance and metabolism, imaging studies, and other tests          as required by the researchers.   "
215426|NCT00663624|"     In the Emergency Department (ED), diabetes is commonly encountered as a secondary diagnosis     and many patients with uncontrolled diabetes are admitted to the hospital after initial     evaluation in the ED. Currently there are no guidelines in the US for the management of     hyperglycemia in patients with diabetes during the duration of evaluation and treatment in     the ED. It is known that high blood glucose levels in hospitalized patients with diabetes are     associated with increased risk of medical complications. In this study, we hypothesize that a     defined two-step approach to the management of high blood sugars with insulin injections     initiated in the ED may decrease length of stay in the ED or hospital, improve clinical     outcome and prevent some hospital complications. In the first phase, patients with diabetes     admitted to the ED that have a high blood sugar (BG 200mg/dL) will be randomized to receive     scheduled aspart or the usual care as dictated by the ED physicians. In the second phase,     patients enrolled in the first phase that are subsequently admitted to the hospital will     receive a combination of detemir and aspart insulin or usual care as dictated by the     Admitting Medicine Team. Detemir is a long-acting insulin which is given subcutaneously     (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously     several times a day and frequently before meals. Detemir and aspart insulins are approved for     use in the treatment of patients with diabetes by the FDA. Usual care can be oral     anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous     insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin     or insulin glargine.      This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta     and at Rush University Medical Center, Chicago, IL. Dr. Smiley will serve as principal     investigator at the Atlanta site. A total of 120 patients will be recruited at Grady and 120     patients at the Rush University Medical Center, Chicago, IL. This study is supported by Novo     Nordisk.   "
215427|NCT00663637|"     The purpose of this study is to measure secretion accumulation within endotracheal tubes of     mechanically ventilated patients and test the efficacy, safety and clinical impact of     removing the secretions using novel airway management catheters (Complete Airway Management     Catheters: CAM Rescue Cath and CAM Endotrach Cath).   "
215428|NCT00663650|"     This study is an equivalency study designed as a randomized clinical trial. Patients with a     biopsy proven nodular periocular basal cell carcinoma (BCC) who have agreed to have surgical     excision will be eligible. Study patients will undergo surgical excision of the lesion and     then be randomized to having frozen section or permanent section pathological control. For     those patients randomized to permanent section control the sample will be sent to pathology     and surgical reconstruction will be performed. Patients randomized to frozen section will     have additional margins re-excised before reconstruction depending on the pathologic results.     Tumor clearance rates after surgical excision will be compared between the two techniques as     a primary study question. Patients will be followed long-term to determine recurrence rates     in the two groups. The study is designed to determine if the two techniques are equivalent     within a given margin of error with respect to outcome measures.   "
215429|NCT00663663|"     Treatments teaching people how to manage pain have been used to treat chronic pain in the     general population. The purpose of this study is to see if these treatments delivered over     the telephone can benefit persons with multiple sclerosis, spinal cord injury or an acquired     amputation. Specifically, we want to determine if these treatments can help reduce the     negative consequences that pain often causes in terms of a person's mood, daily activities,     and enjoyment of life. We are also interested in finding out if these treatments decrease a     person's pain.   "
215446|NCT00663897|"     Functional dyspepsia is a common symptom complex with significant impact on quality of life.     There is no standard treatment for functional dyspepsia but therapeutic efficacy of proton     pump inhibitor (PPI) and prokinetic agent have been proved in subsets of patients. This study     has two aims:        -  first is to compare the therapeutic efficacy of lansoprazole (a PPI) and mosapride (a          prokinetic agent) for functional dyspepsia        -  second is to investigate whether different subgroups of functional dyspepsia (e.g.,          epigastric pain syndrome and postprandial distress syndrome) respond differently to PPI          and prokinetic agent.   "
250289|NCT01126008|"     This phase II trial is evaluating the efficacy of concurrent chemoradiation therapy with     weekly docetaxel and cisplatin combination regimen.   "
215430|NCT00663689|"     This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and     toxicity of erlotinib in patients with asymptomatic brain metastasis advanced NSCLC who was     benefitted by first line chemotherapy. Patients with stage IV NSCLC who have one or more     asymptomatic brain metastasis who was benefitted by first line chemotherapy will receive oral     erlotinib 150mg once daily until disease progression or unacceptable toxicity. These     patients' direct DNA sequencing of tumor tissue EGFR exons 18-21 will be analyzed The     response was evaluated by RECIST criteria after the patient received erlotinib 6 weeks.If the     patients present with progress disease of brain metastasis after the therapy of erlotinib,     the patients will receive irradiation of brain metastasis.If the response is stable     disease,partial response or complete response,he will be examined by brain MRI every 12     weeks.   "
215431|NCT00663702|"     The purpose of this study is to determine whether switching to subcutaneous administration of     abatacept will be safe in participants with rheumatoid arthritis who previously received     long-term therapy with intravenous abatacept   "
215450|NCT00663949|"     Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and     morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic     patients they can not hinder the progression of renal disease completely. Pentoxifylline as a     TNFa blocker may hinder progression of diabetic nephropathy in combination of captopril.   "
215432|NCT00663715|"     Sciatic nerve blocks are frequently used for anesthesia or analgesia for surgery of the lower     legs. Currently, if ultrasound is used to find the sciatic nerve, the leg must be raised to     locate the nerve with the ultrasound probe on the back of the thigh. In pediatric surgery,     the patients are anesthetized (asleep) before the block is given. It is difficult for one     person to administer the sciatic nerve block using this method. We would like to identify the     sciatic nerve using ultrasound on the side of the thigh and its location to the adjacent     structures.   "
215433|NCT00663728|"     This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting,     as compared to placebo (dummy medication with no pharmacological activity), on the duration     of erection from the moment when the patient perceived his erection to be hard enough for     penetration until withdrawal from the partner's vagina leading to successful completion which     may or may not have included ejaculation. The patient used the stopwatch for the above     assessments. The efficacy of oral ED treatments is measured by questionnaires and patient     diaries.   "
215434|NCT00663741|"     This study is to investigate safety, pharmacokinetics and preliminary efficacy profile of     sorafenib in combination with S-1 plus cisplatin in Asian patients with unresectable /     recurrent gastric cancer.   "
215435|NCT00663754|"     This study will evaluate the effectiveness of dissonance-based eating disorder prevention     programs in reducing body dissatisfaction among young women with body image concerns.   "
215436|NCT00663767|"     This is a Phase 2 study designed to test the ability of investigational study drug     ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to     further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled     in this study.   "
215437|NCT00663780|"     The objective of the study is to identify variations in subjects genetic makeup that     segregate responders from non-responders in respect of response to Juvidex in the clinical     trial RN1004-0082   "
215438|NCT00663793|"     We propose a study to determine the single-dose pharmacokinetics of these two novel     formulations of testosterone in normal men with experimentally induced hypogonadism.   "
215439|NCT00663806|"     Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an     educational brochure. - Women with urinary tract infections were treated with Cipro XR. They     were also given a brochure with information about urinary tract infections and later tested     on the information.   "
215440|NCT00663819|"     The primary purpose of this prospective, randomized multicenter center study is to evaluate     and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a     bioabsorbable staple line reinforcement material compared with standard non-reinforced     colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative     anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.   "
215441|NCT00663832|"     This Phase Ib dose escalation study is designed to characterize the safety, tolerability and     preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and     prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.   "
215442|NCT00663845|"     This study is being conducted in US to obtain information on the efficacy, safety, and     duration of erection of flexible-dose regime of vardenafil compared to placebo (dummy     medication with no pharmacological activity), in patients with co-morbid factors associated     with erectile dysfunction (also called impotence). The duration of erection endpoint will be     assessed by patient utilized stopwatch timings during each attempt at sexual intercourse.     Elevated levels of total cholesterol or low levels of HDL may result in atherosclerosis and     induce erectile dysfunction. Vardenafil (Levitra) is approved by the Food and Drug     Administration for the treatment of erectile dysfunction. While there is no intent to assess     the effect vardenafil has on blood lipids, the study will provide prospective data on men     diagnosed with both ED and dyslipidemia.   "
215443|NCT00663858|"     Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is     characterized by an enlargement of the prostate occurring in human male over the age of 50     which increases in prevalence with age, and among those aged 50 to 80, about 40% report     moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve     patients' quality of life which primarily depends on the severity of the symptoms of BPH.     Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.      For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection     in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to     52) are eligible to receive the active drug during the open-label part of the study (Week 52     to 90).   "
215444|NCT00663871|"     Omega-3 fatty acids are a certain kind of fish fat that has recently been shown to have     health benefits. This study will examine the effectiveness of fish oil supplementation for     reducing the early signs of heart disease risk and for improving mood, impulsivity, and anger     levels.   "
215445|NCT00663884|"     We will evaluate the efficacy and safety of combination therapy of 10 mg mitiglinide or 0.2mg     voglibose with insulin glargine for 16 weeks after single administration of insulin glargine     for 4 weeks in type 2 diabetic patients whose glycemic control were not enough despite     administration of oral antidiabetic drug or insulin glargine.   "
250336|NCT01126632|"     Observing the effects of an Olympus cap on the visibility and in adenoma detection during     colonoscopy.   "
215447|NCT00663910|"     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma     skin cancer that has been treated with topical aminolevulinic acid may help doctors predict     how patients will respond to photodynamic therapy.      PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with     nonmelanoma skin cancer.   "
215448|NCT00663923|"     The purpose of this study is to determine whether cross-cylinder approach is more effective     than routine method in laser correction of astigmatism.   "
215449|NCT00663936|"     The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to     treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive     assessment.      The secondary objectives of the study are to evaluate the safety of T-817MA and the     activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to     evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the     ADCS-CGIC.   "
215451|NCT00663962|"     With Institutional Ethics Board approval and signed informed consent, a pilot investigation     was conducted in which 15 adult patients scheduled to undergo a thoractomy were randomly     assigned to receive 1) 150 mg pregabalin 1 hour preoperatively and then 7 days     postoperatively (BID) or 2) 300 mg pregabalin 1 hour preoperatively and 7 days     postoperatively (BID) or 3) placebo for same regimen to assess the feasibility, safety and     compliance of this drug regimen on this patient population. This assessment was necessary in     order to plan a future fully powered randomized controlled trial looking at the efficacy of     perioperative pregabalin ifor reducing the incidence/severity of chronic post-thoracotomy     pain.   "
215452|NCT00663975|"     Hypothesis:DCI 1020 capsules are safe and effective in treating exocrine pancreatic     insufficiency in CF patients <= 2 years of age.      The results of this study are intended to be submitted to the FDA as part of the NDA package     for marketing approval of PANCRECARB (DCI 1020).   "
215453|NCT00663988|"     Progress in composite tissue allotransplantation provides a new remedy for severely     disfigured patients. We plan to carry out allograft composite tissue transplantation after a     careful systemic preparation.   "
215454|NCT00664001|"     Acute mountain sickness (AMS), high altitude pulmonary edema (HAPE), and high altitude     cerebral edema (HACE) are complications of rapid ascent to high altitude. Several features     suggest that raised intracranial pressure (ICP) may be an important factor in the     pathogenesis of AMS. Magnetic resonance imaging of HACE patients has demonstrated that the     oedema in HACE is of the vasogenic, rather that cytotoxic, type. Thus it is likely that     cerebrovascular permeability has an important role in the development of AMS and HACE.      Reactive oxygen species (ROS) have been shown to alter the permeability of the blood-brain     barrier in severe ischaemia, causing vasogenic cerebral oedema. Endogenous antioxidant     systems may have some capacity to respond to oxidative stress in hypoxia. The plasma     concentration of urate, a powerful endogenous antioxidant, rises on acute exposure to high     altitude and may play a crucial antioxidant role in systemic hypoxia. This antioxidant     prevents free-radical induced cerebral oedema in animal models.      There are numerous sources of ROS in hypoxia, including the mitochondrial electron transfer     chain, haemoglobin (Hb) autoxidation and xanthine oxidase activity. There have been several     reports of raised markers of oxidative stress in humans at moderate altitude (<3000m).      Oral antioxidant supplementation with preparations containing vitamins C and E in humans at     altitude has been shown to decrease breath pentanes (a marker of oxidative stress), and     improve erythrocyte filterability. In a small randomised controlled trial, Bailey and Davies     demonstrated a significant reduction in symptoms of AMS in subjects taking an oral     antioxidant cocktail.      The antioxidants alpha-lipoic acid, vitamin C and vitamin E act synergistically to provide     membrane protection from free radical damage, and may protect against hypoxia-induced     vascular leakage. We hypothesised that this combination of antioxidants would reduce the     severity of acute mountain sickness, and reduce pulmonary artery pressures, in healthy     lowlanders acutely exposed to high altitude.   "
215455|NCT00664014|"     This is a randomized, double-blind, multicenter, placebo-controlled (standard therapy +     placebo), phase 2 efficacy and safety study of the Tolvaptan tablets in treatment of patients     with non-hypovolemic non-acute hyponatremia arising from a variety of etiologies. 240 (120 in     each group) patients are to be enrolled randomly into Tolvaptan group or placebo group.     Subjects in Tolvaptan group will receive standard therapy + Tolvaptan (15-60mg/day), while     those in control group receiving standard therapy + placebo. The starting dose of tolvaptan     is 15mg and it could be titrated up to 30mg and then,if necessary, to the maximum of 60mg     according to a certain titration scheme based on patients' response of serum sodium level.     The study includes a 2-day screening period from day -2 to day -1, 7-day inpatient study     treatment (day 1 to day 7 ). After study treatment, subjects will be Followed-up on safety     events on day 14 - 16. The Primary Efficacy Variable is the change of serum sodium from     baseline. For patients with Congestive Heart Failure (CHF) or hepatic cirrhosis, change of     body weight, fluid balance and symptoms improvement of CHF and hepatic edema will be assessed     as secondary efficacy variables.   "
215456|NCT00664027|"     To determine the effects of three different doses of bardoxolone methyl administered orally     on the kidney function (glomular filtration rate) in patients with diabetic nephropathy.   "
215457|NCT00664040|"     Cardiovascular disease (CVD) is the leading cause of death in the United States and many     people that die of heart disease have no previous symptoms. This study will look specifically     at the response to four short-term environmental exposures including: the body's response to     a cold stimulus, to a high fat milk shake, to aspirin, and to a high and low salt diet. These     interventions are all known to influence CVD and people can have different responses to these     interventions, which may be due, at least in part, to differences in genetic make up.   "
215458|NCT00664053|"     The purpose of this study is to examine whether muscle strength and balance will improve in     women with frailty selected for dehydroepiandrosterone sulfate (DHEAS) levels below 550 ng/dl     treated with DHEAS supplementation and Hatha yoga. Investigators believe the effects of both     treatments will improve outcomes more than either treatment alone and may be additive; in     addition, lean body mass, skeletal muscle mass, markers of bone turnover and physical     performance will improve following treatment with DHEA and/or yoga.   "
215459|NCT00664066|"     This is a post-authorisation safety study to assess the incidence and severity of all     pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect &     describe less common adverse drug reactions, and to summarise DYNEPO drug utilisation.   "
215786|NCT00675727|"     This study examines the safety of treating patients with advanced stage melanoma with the     vaccine CADI-05. In addition, preliminary data regarding the clinical response and immune     response will be collected.   "
215460|NCT00664079|"     Thyroid hormones are substances naturally made by the body and are important to many of your     body's basic functions such as breathing and brain function. We are investigating whether or     not these hormones are at lower levels in critically ill children which could lead to further     health problems. We hope to get a better understanding of hormone levels and their effects on     critically ill children to better help other children in the future.   "
215477|NCT00664300|"     Gilles de la Tourette's syndrome is a childhood onset inherited neuropsychiatric disorder     characterised by the presence of both multiple motor tics and one or more vocal tics     (noises), with psychiatric and/or behaviour disorders (such as obsessive compulsive     behaviour…).      This disease is associated with an dopamine system imbalance which could be responsible of a     specific trouble in the recognition in some facial expression. This has been already shown in     Gilles de la Tourette patients with obsessive compulsive behaviour.      We hypothesise that patients with Gilles de la Tourette's syndrome present a dysfunction of     voluntary and automatic treatment of emotional information.      The main purpose of this study is to show if patients with Gilles de la Tourette's syndrome     present a lack of specific facial expression recognition of emotion and determinate more     precisely if this alteration involves the cortical way (high frequency way) or the under     cortical way (low frequency way).   "
215461|NCT00664092|"     The primary aim of this project is to study more closely the role played by post-release     aftercare in the outcomes of criminal offenders who received in-prison substance abuse     treatment. Prison-based therapeutic communities (TC) (Pelissier et al., 2001; Wexler, 1995)     have demonstrated efficacy, especially when combined with post-release TC aftercare (Melnick     et al., 2001). The aims of this project are important from a public health perspective as     there may be treatment matching, case management, and financing factors that could be     manipulated to enhance the cost-effectiveness of community-based substance abuse treatment     for offenders leaving prison. It is possible that both TC and Oxford House(OH) aftercare     modalities increase abstinence social support, self-efficacy, and employment, which mediate     reductions in drug use, reincarceration, and health problems, but overall benefits are likely     to be greater for TCs because they employ professional services and empirically based     behavioral strategies. However, OHs might have advantages compared to more traditional     post-incarceration modalities (e.g., low costs). Bringing scientific methods to the     examination of TCs and the OH community-based recovery models for addiction might help to     identify the active ingredients of these recovery settings.   "
215462|NCT00664105|"     RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination     with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of     docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20     mg/m2 appears to be a well-tolerated weekly dose when combined with either cisplatin 25     mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with radiation     therapy.      PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly     docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic     docetaxel/carboplatin consolidation therapy on overall response rate, survival,     progression-free survival, safety and toxicity in patients with locally advanced NSCLC.   "
215463|NCT00664118|"     Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first     stage of labor would be an effective and safe health care procedure for nulliparas. Doulas,     women with labor experience trained for parturients, is a new way to alleviate the     psychological stress from the laboring pain. Previous data in our study showed that doula     accompany is a good method in shortening the progress of labor used in the active phrase of     the first stage of labor, and decreasing the rate of cesarean delivery. Investigators     hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be     a superior means for effective pain relief, decreased rate of cesarean section, and shortened     duration of labor.   "
215464|NCT00664131|"     Treatment of acute lymphoblastic leukemia achieves high cure rate, but is potentially     neurotoxic.      Long-term neurologic morbidity in survivors and its effect on function are inadequately     studied.      Neurologic outcomes will be assessed through an investigator administered questionnaire     followed by comprehensive neurologic examination by the study neurologist.   "
215465|NCT00664144|"     The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and     treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult     patients, previously treated or not with urate oxidase, with relapsing aggressive     non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky     disease at diagnostic of relapse.      The secondary objectives were to :        -  evaluate the efficacy of rasburicase in terms of renal protection,        -  evaluate the safety of rasburicase in the two cohorts of patients,        -  correlate efficacy and safety results with antibodies generation/level.   "
215466|NCT00664157|"     Parkinson'disease is a neurodegenerative disorder characterised by bradykinesia, rigidity,     rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine     agonists usually leads to a dramatic improvement of symptoms, but disease progression     nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus is     now considered the gold standard surgical treatment.      Parkinson'disease mainly affects the nigrostriatal dopaminergic system which is linked to the     limbic system and could be responsible of a specific trouble in the recognition in some     facial expression.      We hypothesise that patients with Parkinson'disease present a dysfunction of voluntary and     automatic treatment of emotional information.      The main purpose of this study is to show if patients with Parkinson'disease present a lack     of specific facial expression recognition of emotion and determinate more precisely if this     alteration involves the cortical way (high frequency way) or the under cortical way (low     frequency way).      We also examine the role of L-Dopa and the deep brain stimulation on emotion perception   "
215467|NCT00664170|"     The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere     in patients with advanced cancer.   "
215468|NCT00664183|"     The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic     retinopathy patients.   "
215469|NCT00664196|"     This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells     (designer T cells) in hormone refractory prostate cancer.   "
215470|NCT00664209|"     The purpose of this study is to determine whether treatment of H. pylori (an infection of the     stomach) improves treatment effectiveness in patients with Parkinson's disease and motor     fluctuations.   "
215471|NCT00664222|"     The purpose of this study is to evaluate the effects of spironolactone and furosemide on     insulin resistance in patients with chronic heart failure.   "
215472|NCT00664235|"     Long-wave infrared imaging can be used to identify skin temperature changes associated with     underlying tissue changes. We want to determine if the use of Long Wave infrared Imaging is     as effective as the Braden Score in predicting nosocomial pressure ulcers.   "
215473|NCT00664248|"     The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with     acne vulgaris.   "
215475|NCT00664274|"     This project will explore the relationship between catechol-O-methyltransferase (COMT)     Val158/108Met genotype and response to a 12-week computerized neurocognitive rehabilitation     (CRT) given to chronic schizophrenic patients.   "
215478|NCT00664313|"     The antibiotic linezolid when given for the treatment of multi-drug resistant tuberculosis is     safe and tolerated at a low dose (600 mg daily) for a limited duration (16 weeks)   "
215479|NCT00664326|"     This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to     evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or     unresectable renal cell cancer (RCC).   "
215480|NCT00664339|"     We evaluated the preventive impact of vaccination on subsequent death events in 117 severe     congestive heart patients requiring ventilator support without endotracheal intubations and     aggressive medical therapy.      They were randomly allocated in a single-blind manner as a unique intramuscular influenza     vaccination or as controls.      The first primary outcome evaluated at 6 months follow-up - cardiovascular death - occurred     in 3% of the patients in the vaccine group Vs 17% in controls (p=0.022). The composite end     point occurred in 33% of the patients in the vaccine group Vs 74% in control group, p =     <0.001.   "
215481|NCT00664352|"     The objective of this study is to compare the efficacy of two concentrations of Juvidex with     placebo on the healing of split thickness skin graft donor sites   "
215482|NCT00664365|"     This study is the first administration of GSK958108 to man. The study will evaluate the     safety, tolerability and pharmacokinetics of single ascending doses of GSK958108 and evaluate     the effect of food on GSK958108 pharmacokinetics   "
215483|NCT00664378|"     This is a clinical research study that is designed to test the safety of CYT997 when given to     patients with multiple myeloma and to test if CYT997 has any activity against that cancer.   "
215484|NCT00664391|"     The purpose of this study is to demonstrate the safety of the gynecological formulation in     normal and usual usage condition of Dermacyd Breeze.   "
215485|NCT00664404|"     Objectives:        -  To evaluate neural correlates associated with emotional processing during nicotine          withdrawal preferentially involving the amygdala and associated areas within the          corticolimbic and mesolimbic circuitry. We hypothesize that relative to a pre-quit          baseline, post-quit nicotine withdrawal will result in increased activity to negative          emotional cues, in contrast to other cues, in one or more areas of interest, and          particularly in the right cerebral hemisphere.        -  To determine if bupropion and varenicline moderate patterns of brain activation during          post-quit nicotine withdrawal. We hypothesize that relative to placebo, bupropion and          varenicline will attenuate the effects of post-quit nicotine withdrawal on emotional          processing, reducing activation to negative emotional cues, relative to other cues, in          one or more areas of interest, and particularly in the right cerebral hemisphere.        -  To determine if genotype (DRD2 TaqA2 allele and the ins variant of the -141C ins/del          DRD2) moderates patterns of brain activation during post-quit nicotine withdrawal.   "
215486|NCT00664417|"     Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza     vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity     using adjuvants were initiated. The present study is part of this endeavor. It is primarily a     formulation/dose-finding study with a secondary aim at generating safety and immunogenicity     data for the final formulation for the development of a pre-pandemic vaccine.   "
215487|NCT00664430|"     The primary objective of this study is to evaluate the efficacy and safety of paricalcitol in     participants with moderate to severe secondary hyperparathyroidism (SHPT) undergoing     hemodialysis who are resistant to treatment with calcitriol.   "
215488|NCT00664443|"     The overall goal of this study is to better understand the factors leading to successful     dispatch-assisted CPR instructions and to ultimately save the lives of more cardiac arrest     patients. Specific objectives are to: 1) Determine the ability of 9-1-1 dispatchers to make     the diagnosis of cardiac arrest over the phone; 2) Quantify the frequency and impact of     perceived agonal breathing on cardiac arrest diagnosis; 3) Measure the frequency with which     dispatch-assisted CPR instructions can be successfully completed in out-of-hospital cardiac     arrest cases; and 4) Measure the impact of dispatch-assisted CPR instructions on bystander     CPR and survival rates for out-of-hospital cardiac arrest.   "
215489|NCT00664456|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Luteinizing     hormone-releasing hormone agonists may lessen the amount of androgens made by the body.     Internal radiation uses radioactive material placed directly into or near a tumor to kill     tumor cells. Giving luteinizing hormone-releasing hormone agonist together with an iodine I     125 implant may be an effective treatment for patients with prostate cancer.      PURPOSE: This randomized phase III trial is studying how well giving luteinizing     hormone-releasing hormone agonist therapy together with an iodine I 125 implant works with or     without additional luteinizing hormone-releasing hormone agonist therapy in treating patients     with previously untreated prostate cancer.   "
215490|NCT00664469|"     In South Asian Canadians with documented coronary artery disease or diabetes and     hypercholesterolemia with LDL-C levels > 2.0 mmol/L after 4 weeks of monotherapy with any     statin: To compare the percent (%) of patients who achieve an LDL-C concentration of     2.0mmol/L after a 6-week course of treatment with ezetimibe 10 mg/day co-administered with     any statin at any dose versus doubling of the current statin dose.   "
215491|NCT00664482|"     Argos Therapeutics, Inc., (Argos) proposes to study AGS-006 in a subject with newly diagnosed     resectable pancreatic cancer. The AGS 006 immunotherapeutic may potentially offer a desired     additional option to conventional treatments for pancreatic carcinoma.   "
215493|NCT00664508|"     The purpose of this study is to describe the 3D joint biomechanics of the lower extremities     of patients having had a total hip replacement or hip resurfacing surgery as compared to a     healthy age and weight matched control group during level walking, stair ascent and descent,     and entering and exiting the front seat of a car.   "
215494|NCT00664521|"     The primary objective of this study is to assess the safety and tolerability of combined     treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA)     receiving re-treatment with rituximab.   "
215495|NCT00664534|"     This study is designed to look at how best to start and then gradually intensify (as needed)     the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.   "
215496|NCT00664547|"     The purpose of the trial was to examine the independent effects of equivalent diet- or     exercise-induced weight loss on obesity and related cardiovascular health risk factors. We     hypothesized that exercise would result in greater reductions in obesity and health risk     factors that equivalent diet (caloric restriction).   "
215497|NCT00664560|"     We will evaluate the efficacy of PN400 and an active comparator in patients that have     Osteoarthritis of the knee.   "
215498|NCT00664573|"     To observe the long-term treatment with BG9924 when administered to participants with RA who     previously participated in a Biogen Idec Study.   "
215499|NCT00664586|"     This is a Phase I continuous infusion study designed to explore if constant concentration     over time adds to the effectiveness of terameprocol without increasing toxicity. It will also     explore weekly dosing as an option.      Tumor response assessments will be performed following every two (2) cycles of therapy. All     subjects will undergo a follow-up visit 30 days following their last dose of terameprocol.     Circulating tumor cells (CTC) will be quantified pre dosing and on day 15 after first dose of     each cycle. Needle biopsy specimens will be taken prior to therapy and one week after first     dose, if possible, to assess for tumor markers (cdc-2 and survivin). Tumor markers, for     example prostate specific antigen (PSA) will also be measured on day 15 of each cycle (if     elevated on study entry). Pharmacokinetic parameters will be derived from analysis of blood     samples collected during the first 24 hour infusion.   "
215500|NCT00664599|"     The purpose of this study is to find if Rituximab can improve severe ocular lesions of     Behcet's Disease.   "
215501|NCT00664612|"     Intubation is frequently required for trauma patients as part of the resuscitative effort.     When the stability of the cervical spine is unknown, the potential for spinal cord damage     during intubation is significant; the question of the safest intubating technique has not     been resolved. Previous Studies have evaluated Macintosh Laryngoscopy, Bullard Laryngoscope,     face mask ventilation, fibre-optic guided oral and nasal intubation, esophageal Combitube®,     Laryngeal Mask Airway® (LMA), and Intubating Laryngeal Mask Airway® (ILMA) use with respect     to cervical spine movement. Our previous study evaluated the Intubating Lighted Stylet     (Lightwand®) and GlideScope® versus the Macintosh Laryngoscope.      Another method of securing endotracheal intubation, approved and in routine use, is the     AirTraq® videolaryngoscope (ProMedic, Inc, Bonita Springs, FL, USA). The AirTraq     videolaryngoscope is a videolaryngoscope with an external video display of the glottic     opening and an endotracheal tube track to guide the ETT through the vocal cords     (www.airtraq.com). When a clear view of the vocal cords is obtained, the endotracheal tube     may be advanced into the trachea. This technique can be performed rapidly and safely and     there is the perception that it involves less cervical spine movement than direct     laryngoscopy.      We propose to study the AirTraq videolaryngoscope to determine if its use would result in     reduced cervical spine movement during intubation.   "
215502|NCT00664625|"     The primary purpose of this study is to evaluate the safety profile and tolerability of     single oral doses of BMS-791325 in subjects with chronic hepatitis C infection   "
215503|NCT00664638|"     To investigate the clinical utility of renal denervation in the treatment of refractory     hypertension.   "
215504|NCT00664651|"     Our primary research question is to find out whether there is a genetic component to the     development of joint contractures following knee surgery, through the application of lab     techniques.   "
215505|NCT00664664|"     This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in     otherwise healthy adults with primary insomnia primarily with complaints of maintaining     sleep.      Participants will be required to maintain a daily sleep dairy for up to 3 weeks while on     study.   "
215506|NCT00669994|"     This trial evaluated how effective and safe Cipro XR was in treating female patients with     signs and symptoms of a lower urinary tract infections. After 3 days of treatment, patients     were evaluated to determine if signs/symptoms disappeared and the infecting bacteria was     eliminated.   "
215507|NCT00670007|"     This study is a continuation of the placebo-controlled study CE1226_4001 (NCT00261833) to     evaluate the efficacy and safety of Zemaira® intravenous (i.v). administration in subjects     with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a     disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by     volume-adjusted lung density, measured yearly by computed tomography (CT).   "
215508|NCT00670020|"     The purpose of this study is to determine whether supplemental perioperative oxygen     significantly decreases the incidence of post-Cesarean endometritis and wound infection among     women who undergo Cesarean section after the onset of labor.   "
215509|NCT00670033|"     The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost     New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or     ocular hypertension.   "
215510|NCT00670046|"     RATIONALE: Valproic acid may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It is not yet known whether valproic acid is more effective than     observation in treating patients with prostate cancer.      PURPOSE: This randomized phase II trial is studying how well valproic acid works in treating     patients with progressive, non-metastatic prostate cancer.   "
215544|NCT00671008|"     This trial is conducted in Europe.      The aim of this observational study is to evaluate the glycaemic control in patients with     type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.   "
216161|NCT00681070|"     Our research hypothesis in this study is that there is no difference in long-term cosmetic     outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric     facial lacerations.   "
215511|NCT00670059|"     BACKGROUND: Single-embryo transfer is a well-accepted strategy to avoid multiple pregnancies     in an assisted reproductive technology programme. The selection of the embryo with the     highest implantation potential is a crucial step. Besides the morphological quality and     embryo kinetics up to the blastocyst stage, pre-implantation genetic screening (PGS) of     aneuploidy has been advocated as an adjuvant approach by which to select the right embryo for     transfer.      METHODS: Couples with a female partner younger than 36 years were randomly assigned to     undergo transfer of a single blastocyst in a cycle with or without PGS using fluorescence in     situ hybridization for the chromosomes X, Y, 13, 16, 18, 21 and 22.   "
215564|NCT00671281|"     Sinus surgery is a common, day surgery procedure performed by general and subspecialty     trained otolaryngologists. In most cases, this is a safe surgery with a low incidence of     complications. When there is significant bleeding or enough bleeding to obscure important     anatomical landmarks, there is a higher chance of complications. These complications can     include blindness, meningitis or cerebrospinal fluid leak. Our hypothesis is that in patients     taking oral tranexamic acid three days before surgery and six days after, there will be less     intraoperative bleeding, better surgical visualization and less postoperative bleeding     events.   "
215512|NCT00670098|"     The main purposes of the study are to compare changes in sexual function, changes in sex     hormones, and changes in body image and marital satisfaction at 12, 24, 36 and 48 months     postoperatively in two groups: individuals who undergo a bariatric surgical procedure and     extremely obese individuals with similar obesity-related comorbidities who do not seek     surgery (treatment comparison group).      The mechanisms by which extreme obesity affects sexual functioning have received little     attention. Recent epidemiologic studies suggest that obesity and physical inactivity are     independently related to the likelihood of developing sexual dysfunction over time. For     example, men with a BMI greater than 29 kg/m2 have a 30% greater risk of developing erectile     dysfunction and up to 50 % of ED cases can be attributed to hypertension and cardiovascular     disease, both commonly associated with obesity. Many treatments for hypertension have also     been shown to interfere with sexual function.      Changes in sex hormones with increasing BMI have not received much attention either. Obesity     has been associated with decreases in testosterone and sex hormone binding globulin for men     and increases in testosterone and estrogen for women. Several studies have shown improvement     in sex hormone levels in both men and women following weight loss. Sexual functioning has     never been assessed in association with weight loss and whether through improvements in body     image, sex hormones, or obesity related comorbidities, bariatric surgery may have a profound     effect on sexual functioning.      Dr. Ray Rosen, the Principal investigator for this sub study, has conducted a previous     investigation focused on sexual functioning after weight loss in a behavioral weight loss     program. Specifically, he looked at short and long term sexual function outcomes associated     with Type-2 diabetes. His previous work in this area has shown that patients are willing to     participate in studies of sexual function.      The Psychosocial Changes study assesses sexual function in two ways. Participants first fill     out a packet of questionnaires covering topics related to depression, quality of life, body     image, and marital and sexual functioning. They also give a blood sample in order for us to     assess levels of sex hormones including testosterone, luteinizing hormone, estradiol,     follicle stimulating hormone, and others.   "
215513|NCT00670111|"     This study will look at how pacing your heart may assist your daily activities and how you     are feeling.   "
215514|NCT00670124|"     Treatment options in patients with high intracranial pressure due to acute liver failure are     limited. This study intends to evaluate the effect of prophylactic hypothermia on preventing     high intracranial pressure and compromised cerebral oxidative metabolism.   "
215515|NCT00670150|"     The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated     APL will be assessed.   "
215516|NCT00670163|"     This study will evaluate the effectiveness of community-level behavioral and biomedical     interventions, each alone and combined, in reducing sexual risk behavior and HIV/sexually     transmitted infections in Peruvian men who have sex with men.   "
215517|NCT00670176|"     Pre- and postoperative cardiopulmonary rehabilitation reduces complications after coronary     artery bypass surgery. This study was conducted as a randomized trial to verify this     hypothesis in our institution. ICSC   "
215518|NCT00670189|"     The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with     advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule   "
215519|NCT00670202|"     To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of     vascular dysfunction in patients with atherosclerosis.   "
215520|NCT00670215|"     The primary purpose of this clinical trial is to compare in a double-blind randomized trial,     the efficacy and safety of ciprofloxacin MR 1000 mg tablets given as a single-dose or as a     multiple-dose regimen for the prevention of infectious complications in patients undergoing     transrectal needle biopsies of the prostate (TRNBP).   "
215521|NCT00670228|"     Primary objective:      To demonstrate that in hyperglycemic subjects with anterior STEMI (ST Elevation Myocardial     Infarction) undergoing Percutaneous Coronary Intervention (PCI), tight glycemic control using     insulin glulisine and insulin glargine, i.e. Intensive Insulin Therapy (IIT), results in     reducing infarct size at day 60 versus (vs) Standard Glycemic Care (SGC).      Secondary objectives:      To demonstrate that tight glycemic control using insulin glulisine and insulin glargine     reduces markers of inflammation and improves Left Ventricular (LV) function and     Cardio-Vascular (CV) outcomes from baseline values, in hyperglycemic subjects with STEMI     undergoing Percutaneous Coronary Intervention (PCI).   "
215522|NCT00670241|"     This study will compare efficacy and safety of once daily treatment of calcipotriol plus     betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle     alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks     followed by an observation period of up to 8 weeks to investigate the occurence and the time     to relapse and occurence of rebound after discontinuation of the investigational products.     Only subjects with controlled disease will be considered for this observation phase of the     study. Controlled disease is defined as Clear or Almost Clear severity category based     on Investigator's global assessment (IGA).   "
215523|NCT00670254|"     Severe sepsis is a disease with a high mortality. Development of shock is a most serious     complication and increases the risk of death considerably. Application of low dose     hydrocortisone is currently recommended only in patients after severe septic shock has been     established. Hydrocortisone therapy has a hemodynamic stabilizing effect and may reverse     shock, however, the preventive application has not been investigated in a larger study. The     study investigates whether low dose hydrocortisone prevents the development of shock in     patients with severe sepsis. It is postulated that shock prevention may also affect morbidity     and mortality.   "
215524|NCT00670267|"     The purpose of this study is to confirm previous observations in asthmatics that chronic     nadolol treatment reduces asthmatic airway hyper-responsiveness.   "
215561|NCT00671242|"     Purpose: L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for PET. We have     conducted a clinicopathologic study to elucidate the correlation of angiogenesis with 18F-FMT     and 18F-FDG uptake in the patients with non-small cell lung cancer (NSCLC).      Method: Thirty-seven NSCLC patients were enrolled in this study, and a pair of PET study with     18F-FMT and 18F-FDG was performed. Uptake of PET tracers was evaluated with standardized     uptake value. VEGF, CD31, CD34, LAT1 and Ki-67 labeling index of the resected tumors were     analyzed by immunohistochemical staining, and correlated with the clinicopathologic variables     and the uptake of PET tracers.   "
215562|NCT00671255|"     This purpose of this study is to evaluate the safety and effectiveness of Ramelteon, once     daily (QD), in elderly participants with chronic insomnia.   "
215565|NCT00671294|"     This purpose of this study is to assess the efficacy and safety of Ramelteon, once daily     (QD), in elderly subjects with chronic insomnia.   "
215566|NCT00671307|"     This study is designed to assess the pharmacokinetics and safety of an infusion of a single     dose of recombinant plasma gelsolin (rhu-pGelsolin) when given to patients admitted to the     Intensive Care Unit with documented low levels of natural gelsolin. It is believed that this     drug will raise the gelsolin levels in these patients and decrease the probability that they     will develop complications from their underlying disease such as organ system failure or     death.   "
215525|NCT00670280|"     This study is about reducing the risks of smoke-related infant health problems. Research has     shown that infants exposed to secondary smoke have higher risks of delayed lung development,     respiratory illnesses, wheeze, cough, asthma, middle ear disease, and sudden infant death     syndrome. Infants who have experienced low birth weight or required mechanical ventilation     may be at an even greater risk for the negative effects of smoking. The purpose of this study     is to evaluate the effectiveness of a 3-session program aimed at assisting the primary care     giver in reducing risks to their child's health by decreasing infant smoke exposure in their     home and/or reducing overall cigarette use.      Caregivers will not be required to quit smoking to take part in this program. This     information will, in the future, help to identify and improve ways of reducing health     problems and perhaps death in children.   "
215526|NCT00670293|"     This study will use positron emission tomography imaging to investigate changes in dopamine     systems in people with anorexia nervosa before and after weight restoration.   "
215527|NCT00670306|"     Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human     males over the age of 50 which increases in prevalence with age and 40% of males reported     moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of this     study is to collect safety and efficacy data for this dosage regimen of cetrorelix pamoate.      For this study, study medication (Cetrorelix pamoate) is administered by injection in the     buttocks (Intramuscular).   "
215528|NCT00670319|"     To study the effect of long-term treatment with raloxifene, compared with placebo, on the     rate of new vertebral fractures in osteoporotic postmenopausal women with and without     existing vertebral fractures.   "
215529|NCT00670332|"     This study will demonstrate whether patients with prognostically-significant myocardial     abnormalities detected with AI-700 contrast ECHO have a rate of cardiac death or MI that is     higher than that of patients with normal AI-700 contrast ECHO.   "
215530|NCT00670345|"     This prospective randomized double-blind placebo vs control study aims at verifying the     efficacy of tranexamic acid administration in reducing perioperative bleeding in patients     undergoing open radical prostatectomy. Two recent meta-analysis confirmed that tranexamic     acid administration does not increase mortality, myocardial infarction, deep venous     thrombosis, pulmonary embolism, stroke and renal failure.      200 patients undergoing open radical prostatectomy will be enrolled. Patients will receive a     slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by     250 mg/h of tranexamic acid by continuous infusion.      Patients belonging to the control group will receive the same volume of saline infusions.   "
215531|NCT00670839|"     HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic     and severe liver disease, with a major risk of cirrhosis and liver cancer.      However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected     patients, compared to non HIV-infected individuals, and, in case of response, its durability     has to be carefully followed up. This study compares the efficacy of two strategies of     revaccination in HIV-infected patients who didn't respond to previous hepatitis B     vaccination. Failure is defined by two conditions: non response to the primary immunization     (2 to 4 single-dose injections received before the screening visit) and failure to a single     20 µg boost before being included in the study.   "
215532|NCT00670852|"     To investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis     correlates with bony apposition on computed tomography scans, decreased radiolucent lines and     component loosening, and functional outcomes. We hypothesize that by utilizing autologous     bone graft from the resected humeral head, placed around the anchor peg glenoid prosthesis at     implantation, there is a low incidence of glenoid loosening. We suggest that the absence of     radiolucent lines correlated with excellent shoulder function.   "
215533|NCT00670865|"     The purpose of this study is to determine whether a semi-automated electronic patient     discharge summary program leads to increased community physician and housestaff satisfaction     and patient outcomes as compared to conventional discharge reports.   "
215534|NCT00670878|"     This is an open-label, multicenter randomized controlled, Phase III study comparing the     disease free survival after randomisation in patients treated with 3 cycles of     Epirubicin-Fluorouracil-Cyclophosphamide (FEC)-chemotherapy, followed by 3 cycles of     Docetaxel (D)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil- Cyclophosphamide     (FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)- chemotherapy. Patients will be     required to have HER2-neu positive disease and histopathological proof of axillary lymph node     metastases (pN1-3) or high risk node negative, defined as: pT>=2 or histopathological grade     3, or age <= 35 or negative hormone receptor', but are not allowed to have evidence of     distant disease. Patients will have to be entered into the study no later than 6 weeks after     complete resection of the primary tumor. No other antineoplastic treatment other than     surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be     allowed prior to study entry and during the course of the study.   "
215545|NCT00671021|"     The well established importance of regular aspirin administration stands on firm grounds, as     large meta-analyses have shown this therapy to significantly reduce the risk of death.     However, not all patients benefit of aspirin administration to the same extent, thus     high-lighting a sub-population of patients with inadequate platelet response to ASA. The     mechanisms underlying reduced ASA efficacy remain elusive. A recent report has suggested that     platelets, long believed to be incapable of de novo protein synthesis, may retain their     ability to form the cyclooxygenase enzyme, once it has been inactivated by aspirin. This may     explain the inefficacy of the drug to induce sustained platelet inhibition in certain     patients.      The current study aims to evaluate, in patients suffering from stable coronary artery     disease, the stability of platelet inhibition by aspirin during the normal once daily dosing     regimen.   "
215546|NCT00671034|"     This randomized clinical trial is studying giving calaspargase pegol together with     combination chemotherapy to see how well it works compared with giving pegaspargase together     with combination chemotherapy in treating younger patients with newly diagnosed high-risk     acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving     more than one drug (combination chemotherapy) may kill more cancer cells.   "
215563|NCT00671268|"     Efficacy and Safety from a high-dosed subcutaneous recombinant preparation   "
215535|NCT00670891|"     Autism is a developmental and behavioral pattern which includes the triad of impairments, 1.     social interaction 2. social communication 3. imagination. Inevitable difficulties in the     treatment, managing and handle with autistic children are the main problems. Their memories     are seemingly in picture or photo records, which are difference from normal population. There     are many concepts but no concise in causative factors, including useful treatments, useless     and prolong remaining in many studies.      HBOT (Hyperbaric Oxygen Therapy) is a quite modern treatment in Thailand for nitrogen     imbalance (decompression sickness syndrome or Caisson disease). How can we apply it to treat     the autism? A hypothesis shows evidence that neurons surrounding the permanently damaged     epicenter of injury can be reactivated with increased oxygen. Oxygen exists in the blood in     two forms, combined with hemoglobin and dissolved in plasma. More oxygen is transported by     hemoglobin, but oxygen is delivered to the tissues in dissolved form by the liquid portion of     blood. HBOT can increase in plasma oxygen to the tissues including the brain. A little change     in oxygen can make the better improvements in : cognitive ability, socialization, sleep,     calmness, decreased stimming and language. It can make increased in Glutathione (GSH), and     Glutathione (GSH) can decreased in oxidative stress with effected to remove metal compounds     (mercury) to improve the autism.      This clinical trial study divided into 3 group populations 1. general autism 2.     post-treatment chiropractic autism 3. medicated autism. This comparative study shows the     major clinical symptoms before and after the treatment with HBOT. This study results and     analysis are the most important for our further projects planning.   "
215536|NCT00670904|"     This randomized trial compared the effectiveness of a three session pharmacist-delivered     group program for smoking versus one 5 to 10 minute standard care session delivered over the     telephone on 7-day point prevalence quit rates. Participants in both groups were offered     their choice of bupropion IR or nicotine patch at no cost. At 6 months after the established     quit date, self-reported cessation was biochemically verified using tests for urinary     cotinine.   "
215537|NCT00670917|"     RATIONALE: Acupressure may help relieve pain in cancer patients undergoing bone marrow     aspiration and biopsy. It is not yet known whether magnetic acupressure is more effective     than sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration     and biopsy.      PURPOSE: This randomized clinical trial is studying magnetic acupressure to see how well it     works compared with sham acupressure in reducing pain in cancer patients undergoing bone     marrow aspiration and biopsy.   "
215538|NCT00670930|"     This study aims to investigate the effect of omalizumab on the number of tissue eosinophils     and other markers of airway inflammation and remodeling, including thickness of the lamina     reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway     inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists.     This study will also investigate the correlation between systemic and pulmonary inflammation,     and the correlation between clinical outcomes and changes within the tissue, to assist in the     future identification of patients with tissue eosinophilia and their response to treatment,     without the need for invasive bronchoscopy.   "
215539|NCT00670943|"     The well established importance of regular administration of antiplatelet drugs stands on     firm grounds, as large meta-analyses have shown these therapies to significantly reduce the     risk of death. Plavix® (clopidogrel) is widely used following coronary angioplasty, to reduce     the risk of periprocedural thrombotic complications, for up to one year. As the current     recommendations suggest clopidogrel use for no longer than one year, the drug is normally     discontinued within that period. In the limited state of knowledge on antiplatelet drug     withdrawal, an early sound of alarm has risen from early thromboembolic complications     reported after the interruption of antiplatelet treatment used in prevention of ischemic     vascular disease. Although little information is available, discontinuation of     thienopyridines has been associated with increased thromboembolic complications, mainly acute     stent thrombosis. These complications may signal a platelet sensitization effect to     aggregating stimuli by antiplatelet drugs taken chronically.      The current study aims to evaluate the impact of clopidogrel discontinuation on platelet     function, in order to shed light on underlying mechanisms leading to increased risk of acute     thrombo-occlusive events.   "
215540|NCT00670956|"     Congenital cystic adenomatoid malformations (CCAMs) are theorized to be growing immature lung     tissue. Administration of maternal steroids in the mid-trimester may stop the growth or     decrease the size of the CCAM, thus increasing normal lung tissue and improving survival in     fetuses with large CCAMs. This is a prospective, blinded, randomized trial comparing     administration of a single course of antenatal steroids (Betamethasone) to control (i.e.,     placebo). The primary outcome variable will be incidence of hydrops. One month postnatal     survival and relative size of the CCAM as determined by CCAM volume:head circumference ratio     (CVR) between treatment/no treatment groups will be secondary outcome variables. Change in     size of CCAM will be serially followed for both groups with individual growth curves being     plotted prenatally and these will be compared with pathology weigh and volume to evaluate     treatment effect. Other prenatal data collected will include: incidence of polyhydramnios,     incidence of premature rupture of membranes, incidence of material complications. We will     also compare mode of delivery, postnatal respiratory compromise, need for resection in the     first week of life, and occurrence of complications during newborn administration   "
215541|NCT00670969|"     The purpose of this study is to determine, in a group of overweight or obese volunteers, if a     handheld indirect calorimeter can accurately measures oxygen consumption to determine resting     metabolic rate compared to a portable indirect calorimeter.   "
215542|NCT00670982|"     The purpose of this research study is to determine the effects of the combination of     bevacizumab, vinorelbine, and trastuzumab on participants and their cancer.   "
215543|NCT00670995|"     There have been a number of tobacco prevention programs developed and tested in the past few     years, and some of the comprehensive programs have been promoted by the Office on Smoking and     Health at the Centers for Disease Control (CDC). However, the use of these programs and     integration into school-based curriculum has been lacking due to a number of factors. We are     proposing to develop an interactive computer-based program for tobacco prevention aimed at     middle school students. The CD-ROM is designed to be an adjunct to the existing health     education curriculum provided for 6th through 8th grade students.   "
250378|NCT01133431|"     To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in     healthy male subjects.   "
215547|NCT00671047|"     The goal of this study is to enable the study sponsor to develop a new blood test method for     clinicians to accurately predict which individuals with lupus will flare, when the flare will     occur, and flare severity. Ultimately such a newly derived test would allow treating     physicians to start pre-emptive therapy early, with the goal of achieving remission quickly     and with a shorter duration of treatment; identify individuals who will have less severe     flares and will thus require less aggressive treatments; or intensify and lengthen treatment     for those individuals who will need such therapy.      The design of this study is to follow individuals with a known diagnosis of SLE for changes     in disease activity during the course of one year of observation. Clinical data and blood and     urine samples will be collected at scheduled monthly visits. The clinical data and blood     samples will be used for identifying gene expression profile(s) that are associated with     increases in SLE disease activity (lupus flares).   "
215548|NCT00671060|"     The purpose of the proposed study is to test - in a randomized, blinded trial - two different     doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for     fetal death at 14 - 28 weeks, inclusive, of pregnancy. At such an advanced stage of     pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely     evacuation is vital in order to avoid the possibility of, among other things, potentially     life-threatening maternal coagulopathies. Current approaches to uterine evacuation in these     cases include dilatation and evacuation (D&E) surgery (in less advanced pregnancies) and     labor induction with a variety of products. Misoprostol has been demonstrated to be as     effective as, or more effective than, either oxytocin or prostaglandin E2 analogues for this     indication in a number of small, non-FDA-approved trials which have been published in the     peer-reviewed literature. In the absence of more formal study of this treatment, however,     dosages are not standardized, pathways of administration vary, and other uncertainties     linger. The purpose of the protocol proposed herein is to formally establish, via a     randomized, double-blinded study, the safety and effectiveness of misoprostol for this     indication, and to compare the value of two distinct doses, so that providers may     henceforward proceed with greater authority and confidence.   "
215549|NCT00671073|"     This study will assess the safety and efficacy of a range of oglemilast doses. The study will     be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to     one of three doses of oglemilast or placebo.   "
215550|NCT00671086|"     The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD),     in subjects with chronic insomnia.   "
215551|NCT00671099|"     The purpose of this study is to evaluate efficacy and safety of Polyunsaturated Fatty Acid     for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental     injuries.   "
215552|NCT00671112|"     RATIONALE: Everolimus and bortezomib may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when     given together with bortezomib in treating patients with relapsed or refractory lymphoma.   "
215553|NCT00671125|"     The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily     (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of     sleep   "
215554|NCT00671138|"     The disappearance of intestinal parasites from humans in developed countries may be     responsible for the upsurge in many diseases including Celiac Disease, Crohn's, ulcerative     colitis, asthma and hay fever. A parasite's survival relies on its ability to interfere with     the host's immune response. The mechanisms employed to do this are similar to those required     by a person to regulate against the so-called autoimmune disorders, diseases in which the     system turns on itself. The investigators suspect that when parasites are excluded from the     environment, some individuals become sufficiently self-reactive to develop an autoimmune     disease. American researchers have successfully treated patients with Crohn's and ulcerative     colitis using a pig whipworm (Trichuris suis). The investigators have undertaken a similar     preliminary study using a human hookworm in Crohn's patients.      Using a small group of healthy people with celiac disease, the investigators will test if a     human hookworm, Necator americanus, inhibits immune responsiveness to gluten. Celiac disease     is a very common autoimmune-like disease (1% of Americans are affected although only a     minority are aware they have the condition). In this condition, an individual becomes     reactive to gluten, a protein in foods derived from wheat, barley, oats and rye.      What makes celiac disease such a good model for Crohn's disease is that similar immune     changes are common to both, but in celiac disease the people are usually well, are not taking     powerful immune suppressive drugs and the provocative antigens (the molecules that engage the     immune system and provoke the disease) are known and can be excluded or introduced. As well     as being of direct benefit to people with celiac disease, this study may give direction as to     the potential of this parasite to manage inflammatory bowel disease.      People with proven celiac disease who live in Brisbane, a modern Australian city, will be     invited to participate. Enrollment will require that the candidate has been avoiding gluten     for six months.      The study is a blinded study (where the researchers and study subjects do not know who has     gotten the parasites) aimed at comparing the disease activity and immunity after a controlled     breach of the gluten-free diet in individuals with celiac disease, before and after hookworm     infection. The disease severity and the immune system of celiac subjects before and after     being inoculated with N. americanus will be examined using conventional and experimental     investigations. This group's immunity will be compared to that of a group of matched, celiac     control subjects (not infected with hookworm), before and after eating four pieces of     standard white bread each day for three to five days. Twenty people, ten subjects per arm,     will be recruited. Ten larvae initially, then five more after twelve weeks will be placed on     the skin under a light dressing for thirty minutes.      The investigators aim to test whether the hookworm infection will change the immune processes     and suppress gluten sensitivity in people with celiac disease. Outcomes to be measured will     be those that reflect the activity of celiac disease.   "
215555|NCT00671151|"     Molecular mechanisms of COPD exacerbations and the modulating effect of low dose theophylline     on that inflammation are elucidated in this project. NF-kappa B-dependent pathway and     acetylation status of nuclear histones are to be studied.Design: controlled, prospective and     randomized study with or without theophylline, a potent HDAC activator.Objectives: 1) To     determine NF-kB activation, histone deacetylase (HDAC) and histone acetyl-transferase (HAT)     activity in sputum macrophages and blood monocytes during an episode of exacerbation and 3     months later, once stability is achieved. To correlate these measurements with inflammatory     and oxidative stress markers and with pulmonary function and clinical variables. 2) To assess     the effect of theophylline on previous molecular, functional and clinical data. Method: 25     patients with COPD will be recruited during an episode of exacerbation requiring     hospitalization. NF-kB activation, HDAC and HAT activity, markers of inflammation and     oxidative stress will be determined with specific assays. These determinations will be     repeated once the patient is stable and compared with smokers and non smoker controls with     normal lung function   "
215556|NCT00671177|"     Recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the     rectum and left colon through the colonoscope as it is being inserted during a colonoscopy     examination can allow easier endoscope advancement. This method may prevent stretching of the     colon, and ultimately reduce pain induced during colonoscopy. Improvements in patient comfort     and cooperation, may increase the efficiency and success rate of complete colonoscopy. The     purpose of the study is to test the efficacy of the water immersion technique in patients     colonoscopy.   "
215557|NCT00671190|"     The purpose of this study is to determine the phase-advance in circadian rhythms in healthy     adults subjects taking ramelteon, once daily (QD).   "
215558|NCT00671203|"     Patients undergoing surgery on their Aorta can get ischemia, a lack of blood flow, to their     intestines and colon. This is very serious, as 2 out of 3 patients who have this problem die     before leaving the hospital. A device developed by Spectros, called T-Stat, is approved by     the US FDA to detect ischemia, and has been reported to detect ischemia in AAA aneurysm     surgery and stenting, allowing the surgeon or interventional radiologist to take action     quickly, while the colon ischemia is still treatable.      This purpose of this study is to establish how T-Stat can best be used to prevent deaths.   "
215559|NCT00671216|"     GW642444 and GSK233705 are in development for treatment of Chronic Obstructive Pulmonary     Disease. Development of these two inhaled drugs as a combination therapy would have potential     for improved patient benefit as they both work through different mechanisms and the combined     bronchodilatory effect might be additive. This study will look at the this combination, for     the first time, in healthy subjects.   "
215560|NCT00671229|"     The purpose of the study is to determine the role of nitric oxide (NO) in asthma. We     determine the effect of promoter polymorphisms in the gene for the NO producing enzyme,     nitric oxide synthase (NOS2), on exhaled NO in healthy African Americans and Caucasians. We     compare exhaled NO levels between African Americans and Caucasians. Information on race or     ethnicity, serum samples, blood pressure, exhaled breath condensate and health questionnaires     will be collected.   "
215567|NCT00671320|"     To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day     until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in     treating acute first or second degree ankle sprain. The study also compared valdecoxib and     diclofenac with respect to time to onset of pain relief (measured after the first dose),     tolerability (adverse events) and time to return to Normal Function/Activity, among other     measures.   "
215568|NCT00671333|"     The purpose of this study is to compare the effectiveness of two types of operative treatment     in terms of resolving symptoms, improving function and also with respect to x-ray outcomes.      The hypothesis is that insertion of a spacer will provide similar symptomatic relief, but     improved long term gains in key and tripod pinch strength when compared to LRTI.   "
215569|NCT00671346|"     Two large homocysteine-lowering B-vitamin intervention trials have been performed in Norway     during the period 1998 to 2005, NORVIT and WENBIT. The main objective in these trials was to     study the clinical effects of homocysteine-lowering therapy with folic acid and vitamin B12     in patients with established coronary artery disease. Follow-up was terminated for NORVIT on     Marc 31st 2004 and for WENBIT October 5th 2005, and none of the two trials proved any     protective effect of the B-vitamin intervention on cardiovascular outcomes.      There is so far no data on possible long-term effects following years of such B-vitamin     treatment.      Thus, the main objective of the combinded NORVIT-WENBIT study will will be to evaluate the     long-term effect of the B-vitamin intervention on incident life-style diseases including     cardiovascular disease, diabetes, osteoporotic fractures and cancer.      A secondary object will be the identification of risk phenotypes or genotypes, and if such     risk associations are midified by the B-vitamin intervention   "
215570|NCT00671359|"     This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of     TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.   "
215571|NCT00671372|"     This study will assess the safety and pharmacokinetics of adding dulanermin to     Camptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plus     bevacizumab (only for Cohort 6 subjects who have not received prior bevacizumab therapy).   "
215572|NCT00671385|"     The purposes of this study is to establish normal optical values of breast tissue in the     general population. This will allow for establishing normals for breast composition, and is     expected to be useful in the classification of breast lesions into groups such as cysts,     benign growths, inflammatory lesions, and possibly early breast cancer.   "
215573|NCT00671398|"     The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily     (QD), in healthy subjects within a sleep lab.   "
215574|NCT00671411|"     The purpose of this study is to evaluate the blood flow in kidney masses by using ultrasound     microbubble contrast material, and to see if results from ultrasound contrast studies can     predict if a kidney mass is benign or malignant. Patterns of blood flow in the kidney mass     will be examined to see if:        1. benign kidney masses can be distinguished from kidney cancers and        2. if slow growing, lower risk cancers have different blood flow compared to clear cell          cancer which is the most common type of kidney cancer.   "
215575|NCT00671424|"     Many patients with type 2 diabetes also have conditions that are treated with diuretics. The     patients may also be treated with GSK189075 for their diabetes. This study is planned to     assess possible effects of administering GSK189075 in combination with two frequently used     diuretics.   "
215576|NCT00671437|"     The purpose of this study is to collect data and evaluate how the tumor is broken down in     response to standard of care cetuximab treatment by evaluating the FDG-PET/CT scans,     toxicity, see how well the FDG-PET/CT scans predict response to treatment and survival.   "
215577|NCT00671450|"     In an on-going study of visual characteristics of personnel diagnosed with a mild traumatic     brain injury (MTBI) related to their service in Iraq and Afghanistan we found a high rate of     binocular vision problems (such as double/blurry vision, reading difficult, etc.). These     individuals are also usually diagnosed with post traumatic stress disorder (PTSD). PTSD is     known to cause some vision symptoms. We wish to conduct this study on individuals with PTSD     (but not an MTBI) to see if they have symptoms similar to those in individuals who have MTBI.     This will provide us with information useful in determining the specific cause of the visual     symptoms in the MTBI population.   "
215578|NCT00671463|"     The purpose of this study is to investigate an intervention to prevent complications after     pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before     surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are     common after pancreas surgery and can result in serious problems and post-operative pain. The     study will compare two groups. One group will have the stent before surgery, and the other     group will have standard pancreas surgery, no endoscopy, and no stent.   "
215619|NCT00672022|"     We want to see if Zavesca (or miglustat) is safe and can be tolerated by patients with acute     infantile onset GM2 gangliosidosis - classical Tay-Sachs and infantile onset Sandhoff     disease. We know that miglustat inhibits the formation of GM2 ganglioside, the compound that     is stored in the brains of children with Tay-Sachs and Sandhoff disease. Since it inhibits     the synthesis of ganglioside, miglustat may be able to reduce or delay the onset of clinical     symptoms.   "
215579|NCT00671476|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed.      PURPOSE: This clinical trial is studying the side effects of doxorubicin hydrochloride     liposome and to see how well it works in treating women with ductal carcinoma in situ     undergoing surgery.   "
215580|NCT00671489|"     The purpose of this study is to evaluate the efficacy and safety of Polyunsaturated Fatty     Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental     injuries.   "
215581|NCT00671502|"     The purpose of this study is to determine if two sustained released formulations of     carisoprodol are more effective than placebo.   "
215582|NCT00671515|"     The goal of this study is to begin to test whether or not pioglitazone, an FDA approved     medication used to treat high blood sugar, may be safe and effective in treating Major     Depressive Disorder (MDD) in patients with comorbid Metabolic Syndrome (METSYN).   "
215583|NCT00671528|"     This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial     comparing three creams in the treatment of impetiginous eczema:        -  Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin          sulfate)        -  Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream        -  Arm C: Betamethasone diproprionate cream      At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1     randomization ratio to receive one of the three possible treatments for a maximum period of     28 days or until 5 days after total remission of the signs and symptoms, but never more than     28 days. Assessments will be made of level of improvement of the target area in each     treatment group, number of days for total remission, and safety profile.      Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned     participants were enrolled). Statistical analyses were not performed.      Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were     initiated.   "
215584|NCT00671541|"     The purpose of this study is to evaluate a stenting material called Nasopore. This is a     synthetic material approved by FDA for use as a stent in postoperative sinus surgery     patients. This study will compare the Nasopore stent to other approved stenting materials.   "
215585|NCT00671554|"     The purpose of this study is to determine if treatment with the autologous cellular vaccine,     Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage     IV malignant melanoma.   "
215586|NCT00671567|"     The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily     (QD), in adult subjects with chronic insomnia.   "
215587|NCT00671580|"     The purpose of this study is to evaluate the potential effect and safety of two different     doses of PZ-601 and to compare this with another antibiotic that is approved by the US Food     and Drug Administration (also known as FDA) to treat adults with skin and skin structure     infections.   "
215588|NCT00671593|"     The purpose of this study is to identify the genes in important airway cells that are     specifically expressed following inhalation of house dust mite allergen among study subjects     with either allergic asthma or healthy normal phenotypes. This approach is designed to     identify novel genes associated with both asthma pathogenesis (differentially expressed in     the exposure-response study) and asthma susceptibility (genetically associated with asthma in     a linkage/association study) for drug targets.   "
215589|NCT00671606|"     The goal of this clinical research study is to learn if a procedure called intraoperative     (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients     with endometrial cancer.   "
215590|NCT00671619|"     Objectives:      To evaluate the safety, tolerability and pharmacokinetics of ESBA105 administered topically     to the eye for up to 28 days in healthy volunteers.      To determine the systemic exposure to ESBA105 upon single and repeated-dose topical     application to the eye in healthy volunteers.   "
215591|NCT00671632|"     The purpose of this study is to determine the relative abuse potential of ramelteon, once     daily (QD), compared to triazolam in subjects with a history of drug abuse.   "
215592|NCT00671645|"     -  feasibility and tolerance of preoperative therapy with Bevacizumab in combination with          Capecitabine and radiotherapy for patients with locally advanced, locally operable          rectal carcinoma        -  collection of response rate (T- and M-downstaging, pathological complete remission)   "
215593|NCT00671658|"     The goal of this clinical research study is to learn if intensive chemotherapy (with     monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed     by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic     leukemia (ALL) or lymphoblastic lymphoma.   "
215594|NCT00671671|"     Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics,     safety and efficacy in subjects with no or inadequate response to prior treatment.   "
215595|NCT00671684|"     The purpose of this study is to compare the diagnostic yield with endoscopic mucosal     resection (EMR) in hirschsprung's disease versus that of standard rectal suction biopsy. In     order to compare EMR versus rectal suction biopsy, patients' diagnostic specimens will be     analyzed by tissue size, the presence of submucosal tissue, and positive acteylcholinesterase     staining. Additionally, the proportion of patients who would have required subsequent full     thickness surgical biopsy with each technique will be compared. Biopsy results will be     compared with clinical data including history, Bristol stool scale, anorectal manometry     results and SITZ markers studies. Finally, the estimated costs that would have been incurred     with each method will be evaluated.   "
215596|NCT00671697|"     This study is designed to test the combination of decitabine, arsenic trioxide and ascorbic     acid in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia   "
215597|NCT00671710|"     Tumors of the central nervous system are potentially curable. For tumors of comparable     histology and grade, resectability is the most important prognostic factor affecting survival     particularly in children. However, the infiltrative nature of the malignant cells produces     indistinct borders between normal and malignant tissues, and the lack of easily identifiable     tumor margins confounds attempts toward total resection. The investigators propose to     identify the borders of tumors intraoperatively using protoporphyrin fluorescence of the     malignant cells and thereby provide more complete tumor resection.   "
215598|NCT00671723|"     Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it     is currently heavily used in this population. In fact, per evidence of barcode scanning via     Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non     Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed     that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline .     Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is     an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic     fibrosis.      We hereby propose a prospective randomized trial to compare the efficacy of hypertonic     saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis,     mechanically ventilated patient.   "
215599|NCT00671736|"     This is a dose-finding study for the investigational product Lancovutide (Moli1901) in the     exploratory phase IIb to establish minimum effective dose, optimal dose, and maximum safe     dose. Additionally, the tolerability of Moli1901 shall be investigated.   "
215600|NCT00671749|"     This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel     0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel)     applied in the morning, in Subjects with Acne vulgaris.   "
215601|NCT00671775|"     There is growing evidence that obesity is associated with adverse neurocognitive outcome.     Recent studies demonstrate that elevated body mass index (BMI) is an independent risk factor     for Alzheimer's disease, structural brain abnormalities, and cognitive dysfunction in older     adults. Preliminary work from our lab extends these findings and shows structural brain     differences and cognitive dysfunction also exist in obese young and middle-aged adults.      Bariatric surgery is increasingly viewed as an effective intervention for morbid obesity,     though its effects on cognition are unknown. Post-operative nutritional deficiencies are     common and can adversely impact cognitive performance. However, substantial weight loss     resolves or improves many medical conditions with reversible cognitive effects, suggesting     bariatric surgery may provide cognitive benefits.      No study to date has examined the cognitive effects of bariatric surgery. To do so, the     proposed study will prospectively assess cognitive performance in 125 bariatric surgery     patients enrolled in the LABS project and 125 matched controls. Bariatric surgery patients     will complete a computerized cognitive test battery at four time points: pre-operatively, 12     weeks post-operatively, 12 months post-operatively, and 24 months post-operatively. Matched     control participants will complete the test battery at similar intervals. Demographic,     medical, and psychosocial information will be collected to elucidate possible mechanisms of     change. We hypothesize that the substantial weight loss following bariatric surgery will be     associated with improved cognitive performance.   "
215602|NCT00671788|"     Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. This phase II trial is studying how well dasatinib works in treating patients with     persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary     peritoneal cancer.   "
215603|NCT00671801|"     The goal of this clinical research study is to find the highest tolerable dose of     lenalidomide combined with Camptosar (irinotecan) as well as to see if this drug combination     can help control malignant gliomas.      Researchers will also study if a special magnetic resonance imaging (MRI) technique (dynamic     MRI scan) is useful in looking at the effect of treatment on the tumor. Another goal is to     learn the effect of lenalidomide on tumor tissue in patients who need surgery for the     disease.   "
215605|NCT00671827|"     The goal of this observational study is to collect information about the length of surgery,     the procedures performed during surgery, and any possible side effects of robot-assisted     gynecologic cancer surgeries. The researchers also want to learn if patients who have     robot-assisted surgeries have fewer complications during recovery.   "
215606|NCT00671853|"     The primary objective is to test the hypothesis that Quetiapine XR (Extended Release)     monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression     and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a     substance use disorder. The secondary aim is to generate an estimate of effect size to power     a definitive large-scale, multi-site collaborative R01 and to configure the use of the     primary and secondary outcome measures in the definitive large-scale study.   "
215607|NCT00671866|"     During 1987-1991, WHO supported studies of exposures and short term neurobehavioral effects     in a cohort (n=200) with occupational and community exposures to pesticide drift containing     organophosphates from orchards and cotton fields in the Hula Valley. We aim (1) to re-examine     neurobehavioral outcomes in members of the original cohort and (2) to examine cognitive     effects in children with residential exposures. In adults, we will carry out assays of alkyl     phosphates, PON1 (paraoxonase-1), NTE (Neuropathy Target Esterase), neurobehavioral tests of     cognitive and performance skills, nerve conduction measurements and mood status. We will     carry out Psycho-Didactic tests in children. The findings will advance knowledge on delayed     term health effects of lengthy everyday exposure to OP pesticides and guide regulatory     policy.   "
215608|NCT00671879|"     The purpose of this study is to determine if two sustained released formulations of     carisoprodol are more effective than placebo.   "
215609|NCT00671892|"     The overall goal of this project is to identify genes that are involved in the development of     airflow obstruction and airway inflammation in asthmatics, and to determine whether     polymorphisms in these differentially expressed genes predispose individuals to develop     asthma. In this project, we hypothesize that polymorphisms of genes expressed by the airway     epithelia in asthmatics following specific airway challenges predispose individuals to the     development of asthma.   "
215620|NCT00672035|"     The main purpose of this study is to evaluate the body's immune response to the LT patch at     different doses.      The secondary purpose of this study is to evaluate the safety of the LT patches at different     doses and the safety of the skin preparation system. Another secondary purpose is to compare     the safety and the body's immune response to LT patches placed on the upper arm versus the     lower back.   "
215621|NCT00672048|"     The purpose of this study is to develop new ways of assisting patients with glaucoma and     their eye doctors in using the recommendations from practice guidelines.   "
215610|NCT00671905|"     The investigators have recently shown that anatomic ganglionated plexi (GP) ablation is     inferior to circumferential pulmonary vein (PV) ablation for the treatment of paroxysmal AF.     In this study, however, 26% of patients subjected to GP ablation alone without     circumferential lesions were free of AF-recurrence up to one year after the ablation     procedure. The investigators hypothesized that a combination of circumferential ablation with     high-frequency-stimulation-identified GP ablation is superior to conventional circumferential     ablation for the prevention of recurrences of paroxysmal atrial fibrillation (AF). The     investigators are, therefore, conducting a randomized study comparing conventional     circumferential ablation to a combination of circumferential ablation plus specific right and     left atrial GP ablation in patients with drug-refractory paroxysmal AF.   "
215611|NCT00671918|"     Data from this pivotal clinical trial will be used to support a marketing application (i.e.,     NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes)     in the lymphatic pathway draining the primary site of a tumor.   "
215812|NCT00676065|"     The objective of this study is to characterize and compare the risks of long-term use of oral     contraceptives containing drospirenone and of other established oral contraceptives.   "
215612|NCT00671931|"     Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the     anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the     development of neurological deficits remains the most feared complication of spine surgery.     During scoliosis surgery it is very important to monitor the spinal cord to detect spinal     cord injury with surgical manipulation. Continuous or intermittent intraoperative     electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures     to provide the surgeon with information concerning the integrity of neurological structures     at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the     various intravenous anesthetic drugs, the combination of propofol, remifentanil and     dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice     is to use the three drugs in combination at doses that do not depress the signals but there     is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring     signals. The lack of data results in wide variability in dosing with consequent variability     in patient response.      Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of     transcranial motor-evoked potentials (TcMEP) either independently or by interaction with     propofol in a dose dependent manner.   "
215613|NCT00671944|"     Osteoporosis is a major health problem in men and women in this country and the incidence of     this disease is rising. We think that environmental factors such as nutrition may play a role     in the increasing prevalence of osteoporosis. In particular, we think that a diet that is too     low in protein may be contributing to bone loss. The primary purpose of this study is to     compare the long-term impact of a low protein diet on measures of bone and calcium     metabolism.   "
215614|NCT00671957|"     The aim of this study is to assess whether the energy you burn daily increases after you have     bariatric surgery. Until now, there hasn't been an effective way of measuring all activity on     a daily basis. Physical Activity Monitoring System (PAMS) has been created just for this     purpose. PAMS is a garment that can be worn under your clothes, that records body position     and movement through space. We will use the PAMS along with special water to measure your     total daily energy expenditure right before surgery, and again 6 months and 24 months after     surgery.      Study subjects will be initially recruited from OHSU IRB-Approved advertisements. Interested     study subjects will be screened through an informal telephone interview. If there are no     health conditions that exclude participation, subjects will be asked to give IRB-approved     consent.      Subjects will be consenting to undergo three 18 day phases. Each phase will consist of 15     daily visits to the Clinical & Translational Research Center (CTRC), and 3 full day and     nights in the CTRC.   "
215615|NCT00671970|"     Primary objective:      To estimate 6-month progression free survival probability of pts w recurrent malignant     gliomas treated w erlotinib + bevacizumab.      Secondary Objectives:      To evaluate safety & tolerability of erlotinib + bevacizumab among pts w recurrent malignant     gliomas To evaluate radiographic response of pts w recurrent malignant gliomas treated w     erlotinib + bevacizumab To evaluate pharmacokinetics of erlotinib when administered to pts w     recurrent malignant gliomas; & to examine relationship of clinical response to Epidermal     Growth Factor (EGFR) expression, amplification, & v-III mutation, phosphatase and tensin     homolog (PTEN) expression, vascular endothelial growth factor (VEGF) expression, vascular     endothelial growth factor receptor 2 (VEGFR-2) & phosphorylated protein kinase B (PKB/Akt) in     archival tumor samples   "
215616|NCT00671983|"     Obstructive sleep apnea (OSA) is a syndrome characterized by repetitive episodes of airway     obstruction during sleep, which result in low oxygen level in the blood and bad sleep     quality. Both of these effects are implicated in medical, neurological and cognitive     disorders in subjects with OSA. The purpose of this study is to examine how OSA affects     medical and neurobehavioral outcomes after gastric bypass surgery for weight loss in morbidly     obese patients.   "
215617|NCT00671996|"     The present feasibility study is designed to find out whether pre-treatment with the compound     mangafodipir lowers the frequency and severity of side effects during adjuvant chemotherapy     according to the FOLFOX6 regimen in patients operated upon colon cancer in stage Dukes' C.   "
215618|NCT00672009|"     The purpose of this research study is to determine the safety and effectiveness of the     investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive     surgery.      Prostate cancer is a common and important health issue facing men in the United States. Most     patients with prostate cancer are identified when the disease is limited to the prostate     gland itself (localized prostate cancer). A standard treatment for some patients with     localized prostate cancer is removal of the prostate gland in an operation known as a     radical prostatectomy. A sub-set of patients with localized prostate cancer can be     identified who are at high-risk of suffering a recurrence of prostate cancer after radical     prostatectomy. For these patients, additional treatments are being investigated to combine     with surgery in the hopes of increasing the chances for cure.      Several kinds of chemotherapy medicines have been used for advanced prostate cancer which     returns after initial therapy. Epothilones are a newly developed class of chemotherapy drugs     that appear promising for the treatment of many forms of cancer. Ixabepilone is drug in the     epothilone class of chemotherapy medicines that has shown encouraging results for the     treatment of advanced prostate cancer and other cancers in clinical trials.      This trial will include men with high-risk localized prostate cancer who will receive     treatment with ixabepilone (4 cycles over 12 weeks) prior to radical prostatectomy. The goal     of this trial will be to determine if analysis of genes and proteins in prostate cancer     tissue taken before and after treatment can be used to predict ixabepilone response. In     addition, this trial will evaluate the safety and feasibility of administering ixabepilone     prior to radical prostatectomy for patients at high-risk of developing recurrent prostate     cancer.      The study has three phases: Screening, Treatment and Follow-up        -  Screening: Eligibility will be verified        -  Treatment: Subjects will receive Ixabepilone, which will be administered every 21 days          for 4 cycles prior to surgery        -  Follow up: Subjects will be followed every 6 months for up to 5 years.      In addition, tissue will be collected at the time of surgery for genetic and protein studies.     Blood will also be collected pre and post therapy for proteomic and/or genetic studies.   "
215622|NCT00672061|"     The purpose of this study is to assess the safety of ramelteon, once daily (QD), in     individuals with obstructive sleep apnea.   "
215636|NCT00672256|"     The broad objective of this proposal is to identify functional neuroanatomical correlates of     impairments in response inhibition during smoking abstinence. We will measure changes in     performance and regional blood oxygenation levels using functional magnetic resonance imaging     (fMRI)while smokers complete tasks designed to assess decision making and response     inhibition.      Our primary hypothesis is that smoking abstinence will result in impaired response inhibition     accompanied by decreases in blood-oxygenation-level-dependent (BOLD) fMRI signal in brain     regions associated with these cognitive processes including frontal cortex and the ventral     striatum. Abstinence may also result in performance-related increases in activation in brain     regions associated with effortful processing including the anterior cingulate cortex in     effort to compensate for deficits in other regions.   "
215637|NCT00672269|"     There is a high incidence among the first degree relatives of the carcinoid patients,     indicating the involvement of genetic components in its initiation and pathogenesis.   "
215624|NCT00672087|"     The etiology and pathogenesis of interstitial cystitis (IC) and its related condition in men,     chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has remained elusive. This has     hampered development of mechanistic treatment strategies for these common, chronic and     distressing medical conditions. We believe that IC and perhaps CP/CPPS are a spectrum of     complex but inter-related genetic and acquired diseases resulting from the interaction of     several genes regulating immune/inflammatory and neurogenic parameters and environmental     factors/circumstances or exposure, culminating in the combination of pain, frequency, urgency     and sexual specific symptoms. New research has delineated the dynamic and powerful     association of the immune and neurogenic system in pain activation. An immune-modulated     neurogenic model of IC illuminating the action of immune derived substances and pain related     substances might be important in discovering the determinants of pain, voiding dysfunction     and gender specific sexual problems. This inter-related dynamic model of IC disease     pathogenesis could be explored for potential avenues leading to novel diagnostic and     treatment strategies. We plan to identify and evaluate the sensitivity and specificity of     several novel nerve and inflammation related markers in the diagnosis and follow up of IC     (and CP/CPPS). By correlating the levels of urine immune and pain related substances to     disease mechanisms, severity and progression, we may be able to create a human disease     specific model for diagnosis and treatment.   "
215625|NCT00672100|"     Objective: To determine a minimally effective initial local anesthetic bolus required to     provide satisfactory analgesia using continuous brachial plexus infusion following     arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial     doses.   "
215626|NCT00672113|"     This study compares the effect of Adalat LA to Coracten on drug levels as well as changes in     blood pressure and heart rate in fed hypertensive subjects. Subjects are dosed with either     Adalat or Coracten for first 2 weeks, followed by the other drug for 2 weeks, and then     switched back to the original drug for one day. Blood samples, blood pressure, and heart rate     are taken before and after each treatment period.   "
215627|NCT00672139|"     This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the     safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will     be tested in late stage, advanced illness patients who have constipation caused by opioid     pain relievers. This study will last 3 months.   "
215628|NCT00672152|"     The purpose of this study is to determine the safety and effectiveness of administering Wilms     tumor gene 1 (WT1) cancer peptides. Cancer peptides are short pieces of protein that are made     in a laboratory to be like the peptides that can be found in cancer. These peptides are     intended to be given as a vaccine to activate the immune cells in a person to attack     his/her cancer. These peptides are mixed with an oily substance called Montanide ISA-51 and a     white cell growth factor called Granulocyte-macrophage colony-stimulating factor (GM-CSF)     which may help make the immune response stronger.   "
215629|NCT00672165|"     The purpose of this study is to find a safe dose of actinium-225 when it is labeled to     HuM195. This will be done with a phase I trial, in which a preset schedule of doses gets     more powerful for each new group of patients as the trial progresses. If too many serious     side effects are seen with a certain dose, no one will be treated with a higher dose, and     some additional patients may be treated with a lower dose to make sure that this dose is     safe. The starting dose of actinium-225 in this study is less than doses that are known to be     safe in animals.      Antibodies are proteins that are produced by the immune system and help the body to fight     foreign substances, such as bacteria or viruses. HuM195 was made by putting human leukemia     cells into mice. Most of the mouse parts of this antibody were replaced with human parts.     Only the part of the antibody that binds to the leukemia cells was kept from the mouse.     HuM195 attaches to leukemia cells but does not attach to most normal cells. It can kill small     amounts of disease by identifying the leukemia cells as foreign. HuM195 has worked less     well against large amounts of leukemia since the normal immune cells needed to kill leukemia     cells are lowered in most patients with leukemia.   "
215630|NCT00672178|"     The purpose of this study is to determine the safety and efficacy of combined stereotactic     body radiotherapy (SBRT) + sorafenib in the treatment of patients with Stage IV renal cell     carcinoma (RCC) who have recurred locally, developed progression of an unresectable primary     or progression of extra-cranial and/or extra-pulmonary metastases while on sorafenib. All     subjects will remain on sorafenib during SBRT.   "
215631|NCT00672191|"     The purpose of this study is to examine the ability of AGS-004 to control HIV-1 replication     and to determine if HIV-1 immunotherapy made with dendritic cells is safe and well tolerated,     to determine if immunotherapy increases the body's immune response to HIV-1; and, to     determine if after stopping anti-HIV drugs, immunotherapy can control the HIV-1 virus.   "
215632|NCT00672204|"     The primary objective of this protocol is to test the safety and efficacy of a treatment     regimen consisting of maintenance therapy with efalizumab and sirolimus for 1 year followed     by withdrawal of efalizumab and maintenance therapy with sirolimus, for the prevention of the     destruction and rejection of islet transplants in type 1 diabetic recipients.      Genentech, the manufacturer of efalizumab voluntarily withdrew the drug from the U.S. market     in April of 2009. Previously transplanted subjects have been transitioned to alternative     immunosuppressives and no new subjects will be transplanted under this protocol.   "
215633|NCT00672217|"     The primary goal of the proposed study is to examine a cognitive behavioral intervention for     insomnia (CBTI) in women after breast cancer treatment. Chronic Insomnia is a highly     prevalent and distressing symptom in cancer patients. CBTI is considered the treatment of     choice for chronic primary insomnia. Few studies have been conducted in cancer survivors to     evaluate the effect of CBTI on sleep and clinically relevant outcomes.   "
215634|NCT00672230|"     The clinical trial aspect of this study is the provision of a lutein supplement to lactating     women and compare the amount of lutein in the milk and blood with lactating women who do not     receive the lutein supplement.   "
215635|NCT00672243|"     Primary objective:      To determine the 6-month progression free survival of patients with recurrent glioblastoma     multiforme (GBM) treated with Erlotinib plus Sirolimus.      Secondary objectives:      To further define the safety and tolerability of Erlotinib plus Sirolimus when administered     to patients with recurrent GBM; and to evaluate progression free survival, radiographic     response and overall survival of patients with recurrent GBM treated with Erlotinib plus     Sirolimus.   "
215638|NCT00672282|"     The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy,     versus placebo, in subjects who have either undergone a primary therapy (principally radical     prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.   "
215639|NCT00672295|"     Primary objective to determine the maximal tolerated (MTD) of dasatinib in combination with     paclitaxel and carboplatin during the first cycle of treatment.      Secondary objectives to describe the toxicity of this combination of therapy; to describe the     pharmacokinetics and pharmacodynamics parameters related to this combination; to describe the     clinical activity as defined as the response rate (complete and partial response rate) and     progression-free survival > 6 month; to compare the SRC pathway microarray signature in pre     and post-treatment cancer specimens; to evaluate SRC pathway downstream substrates, FAX,     paxcillin, and CRK-L in pre and post-treatment cancer specimens.   "
215640|NCT00672308|"     In cholera, the function of small intestine is affected resulting in increased secretion of     electrolytes and water and their reduced absorption leading to profuse watery diarrhoea. The     human colon has the capacity to absorb water and electrolytes. A number of recent studies     have shown that short chain fatty acids (SCFAs) such as acetate, butyrate and propionate     stimulates absorption of sodium in the colon, which is not affected by cyclic AMP. It has     also been shown that SCFAs inhibits c-AMP mediated chloride secretion in the colon. Benefiber     (partially hydrolyzed guar gum) is water soluble fibre, and when added to ORS it undergoes     fermentation in the colon liberating SCFAs. SCFAs not only serves as metabolic fuel to the     enterocytes but they also enhance colonic absorption of salts and water. Thus, they have     potentials to reduce the severity of diarrhoea in patients with cholera. The aim of this     study is to assess the efficacy of Benefiber-added WHO-ORS in the management of adults with     cholera. In this randomized, controlled clinical trial, a total of 174 adult males with     cholera would be studied. Study patients would be selected from those who attend the Dhaka     Hospital of ICDDR,B with a history of diarrhoea of less than 24 hours and signs of severe     dehydration. They would be rehydrated using intravenous fluid (cholera saline) over 4 hrs     during which a stool specimen would be subjected for dark-field microscopy for identification     of V. cholerae. Those identified to have cholera would be randomized in equal numbers to     receive either: a) Benefiber (25 g/L) added WHO-ORS, b) Benefiber (50 g/L) added to the new     formulation (Na+ 75, glucose 75, Cl- 65, K+ 20 mmol/L, citrate 10 mmol/L, osmolarity 245     mosmol/L) of WHO-ORS , or c) the same WHO-ORS but without Benefiber for maintenance of     hydration until resolution of diarrhoea. All patients would be treated with a single, 300 mg     dose of doxycycline capsules and would be provided with the standard hospital diets. Fluid     intake (intravenous fluid, ORS, and plain water) and output (stool, urine, and vomit) will be     measured for each 6-hourly periods of the study. Patients would be hospitalized until     resolution of their diarrhoea. Stool output, intake of intravenous fluid and ORS, the     duration of diarrhoea, and the proportion of patients requiring unscheduled intravenous     fluid therapy would be compared between the treatment groups. If Benefiber is found     effective, it would be possible to formulate improved ORS for better case management of     cholera.   "
215641|NCT00672321|"     RATIONALE: Gathering information about vitamin D supplementation and sun exposure in patients     with melanoma may help doctors learn more about the disease and find what may affect cancer     relapse.      PURPOSE: This clinical trial is studying vitamin D supplementation and sun exposure in     patients who have undergone surgery for stage IB, stage II, or stage IIIA melanoma.   "
215642|NCT00672334|"     With over one million operations a year, cardiac surgery with cardiopulmonary bypass is one     of the most common major surgical procedures worldwide (1). Acute kidney injury is a common     and serious postoperative complication of cardiopulmonary bypass and may affect 25% to 50% of     patients (2-4). Acute kidney injury carries significant costs (4) and is independently     associated with increased morbidity and mortality (2,3). Even minimal increments in plasma     creatinine are associated with an increase in mortality (5,6).      Multiple causes of cardiopulmonary bypass-associated acute kidney injury have been proposed,     including ischemia-reperfusion, generation of reactive oxygen species, hemolysis and     activation of inflammatory pathways (7-10). COMT LL genotype appears to increase the risk of     vasodilatory shock and AKI after cardiac surgery. To date, no simple, safe and effective     intervention to prevent cardiopulmonary bypass-associated acute kidney injury in a broad     patient population has been found (11-14).      Urinary acidity may enhance the generation and toxicity of reactive oxygen species induced by     cardiopulmonary bypass (10,15). Activation of complement during cardiac surgery (16) may also     participate in kidney injury. Urinary alkalinization may protect from kidney injury induced     by oxidant substances, iron-mediated free radical pathways, complement activation and tubular     hemoglobin cast formation (9,17,18). Of note, increasing urinary pH - in combination with     N-acetylcysteine (19,20) or without (21) - has recently been reported to attenuate acute     kidney injury in patients undergoing contrast-media infusion.      In a pilot double-blind, randomized controlled trial the investigators found sodium     bicarbonate to be efficacious, safe, inexpensive and easy to administer. These findings now     need to be confirmed or refuted by further clinical investigations in other geographic and     institutional settings.      Accordingly, the investigators hypothesized that urinary alkalinization might protect kidney     function in patients at increased risk of acute kidney injury undergoing cardiopulmonary     bypass needs to be confirmed in an international multicenter, double-blind, randomized     controlled trial of intravenous sodium bicarbonate.   "
215643|NCT00672347|"     Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better     postoperative analgesia than either drug alone after urogenital pediatric surgery.   "
215644|NCT00672360|"     New evidence suggests that autistic disorder (AD) may be associated with abnormalities in     folate metabolism, which is a process that affects genetic expression by facilitating the     formation of methyl donors for DNA methylation. Limited data show that some children with AD     show behavioral improvements with folic acid (FA) therapy, while others show a worsening     effect. If behavioral worsening is linked with abnormalities in folate metabolism, then     nutritional modifications could normalize these processes and result in clinical     improvements. To address this premise, we propose a randomized, placebo-controlled crossover     pilot study with two phases. The first phase will focus on the behavioral and biochemical     responses of children with AD to high-dose folic acid supplementation. Because FA is an     inactive folate that requires biochemical conversion to become active, and select genotypes     impede this conversion, our general hypothesis is that FA will yield behavioral improvements     in some children but exacerbate problem behaviors in others. During the second phase,     children who had a worsened behavioral response to FA during phase 1 will participate in an     open-label trial of high-dose Metafolin® supplementation. The focus here would similarly be     on the behavioral and biochemical outcomes of participating children following treatment with     the study supplement. Because Metafolin® is an active folate metabolite that should not be     affected by genotypes in the folate pathway, our general hypothesis for phase 2 is that     Metafolin® would yield behavioral improvements without the risk for behavioral worsening.     Results from this project may provide support for continued study of the potential     relationship between folate metabolism and problem behaviors among children with AD,     potentially justifying the need to examine effects of folate supplementation among a larger     sample of affected children.   "
215645|NCT00672373|"     The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in     the treatment on Tardive dyskinesia   "
216598|NCT00684788|"     The purpose of this study is to determine whether employment-based naltrexone treatment     proves effective in promoting depot naltrexone adherence and drug abstinence.   "
215646|NCT00672386|"     The purpose of this study is to investigate the effectiveness and safety of 12 weeks of     treatment with R256918 in patients with Type 2 Diabetes Mellitus who are taking metformin.     The primary measure of effectiveness is the change in concentration of glycated hemoglobin     (HbA1c) during treatment. Glycated hemoglobin is a substance in red blood cells that is     formed when blood sugar (glucose) attaches to hemoglobin and is a measure of diabetic status.     Additional measures include fasting glucose, and lipid levels, and body weight. Safety     assessments performed during the trial include laboratory tests, vital sign measurements, and     adverse event reporting.   "
215647|NCT00672399|"     This Phase 1, randomized, three period, placebo- and positive-controlled,double-blind,     double-dummy, crossover study will be performed with approximately 80 healthy male and female     subjects. The effects of single doses of exenatide (10 μg, subcutaneous), moxifloxacin (400     mg, oral) or placebo(subcutaneous or oral) on QT interval will be assessed.   "
215648|NCT00672412|"     In 2005, there were 50,620 HIV-infected children living in Thailand. Current anti-HIV     regimens, comprised of individual pills for each drug, frequently lead to missed doses. To     properly control their infection, regimens that are tolerable and effective in children and     without pill burden are necessary. The primary purpose of this study is to evaluate the     safety and bioavailability of GPO-VIR Z30, a combination fixed dose tablet containing     zidovudine (ZDV), lamivudine (3TC), and nevirapine (NVP), in HIV-infected children in     Thailand.   "
215649|NCT00672438|"     Proposed twin study will test to what degree inter-individual differences in pain sensitivity     and amount of pain relief in response to opioid therapy are inherited or alternatively, are     due to environmental factors. This knowledge is important to guide future studies trying to     explain such inter-individual differences. For example, finding that differences are largely     due to environmental factors would discourage genomic studies and emphasize epidemiological     studies.   "
215650|NCT00672451|"     Rhubarb extract is a chinese herbal preparation that is used in china and other asian     countries to treat constipation and chronic kidney disease. Use of angiotensin converting     enzyme inhibitors (ACEI) in diabetic kidney disease has been shown to be beneficial in     slowing progression. The purpose of this study is to determine the combined effect of rhubarb     plus enalapril (an ACEI)in slowing the rate of decline of CKD in people with kidney disease     from diabetes.   "
215651|NCT00672464|"     Primary Objective: To compare added metformin and/or added simvastatin versus no intervention     in reducing or eliminating increased cardiovascular risk (as estimated by elevation in     non-HDL cholesterol levels) during the treatment of schizophrenia with olanzapine.      Secondary Objective(s): To compare added metformin and/or added simvastatin versus no     intervention in reducing or eliminating increased cardiovascular risk (as estimated by     elevation in triglyceride levels) during the treatment of schizophrenia with olanzapine. To     compare added metformin and/or added simvastatin versus no intervention in reducing or     eliminating increased cardiovascular risk (as estimated by C-reactive protein levels) during     the treatment of schizophrenia with olanzapine   "
215652|NCT00672477|"     This study will evaluate the safety and efficacy of methylnaltrexone administered as     subcutaneous injections in subjects who have opioid-induced constipation and an advanced     illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving     opioid-induced constipation in these subjects.   "
215653|NCT00672490|"     To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct     therapy to lithium in the treatment of patients with acute mania in bipolar disorder.     Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria     (296.4X Bipolar I Disorder, Most Recent Episode Manic; 296.0X Bipolar I Disorder, Single     Manic Episode) are required to have a YMRS total score of ≥20 at enrolment and randomisation   "
215654|NCT00672503|"     The purpose of this study is to identify risk factors associated with indwelling urinary     catheters, as well as to assess the nurses' knowledge and adherence to hospital policies. The     study will also include a very extensive literature search in an attempt to create a national     standard or guideline.   "
215655|NCT00672516|"     We believe ongoing bleeding during complex cardiac surgery can be accurately measured and     that administration of a specific blood product replacement strategy designed to optimally     slow or stop the bleeding can be followed by the during the operation.      Patients at risk of significant bleeding after complex cardiac surgery will be approached to     allow their operation to be watched by study personnel to see if ongoing blood loss can be     accurately measured and to see how quickly a prescribed, standardized blood product     replacement protocol to control the bleeding does slow or stop the bleeding. Permission to     review the medical record to see if bleeding risk features can be identified and permission     to follow the patient after surgery to see how they recover is also requested.   "
215656|NCT00672529|"     The purpose of this study is        1. To pilot the research methodology for a randomized trial on an orthomolecular treatment          regime versus placebo as add-on therapy for children with asthma;        2. To obtain a preliminary estimate of the effectiveness of an orthomolecular treatment          regime for allowing tapering of inhaled corticosteroids in clinically stable asthmatic          children. The obtained estimate will allow sample size calculations for a full-scale          randomized trial; and        3. To obtain preliminary information about the safety and tolerability of an orthomolecular          treatment regime.   "
215657|NCT00672542|"     Transfection with siRNA targeting the immunoproteasome alters proteasome-mediated antigen     processing by the dendritic cell, generating TAA-derived peptides that we hypothesize, based     on preclinical results, will induce enhanced anti-melanoma immune responses. This phase I     study, open to subjects with metastatic melanoma, will assess the safety of vaccination with     melanoma tumor associated antigen-encoding RNA-transfected mature dendritic cells derived     from monocytes that have been either untreated, transfected with control siRNA, or     transfected with siRNA targeting the inducible immunoproteasome beta subunits LMP2, LMP7, and     MECL1. A combination of RNAs encoding melanoma tumor associated antigens MART-1, tyrosinase,     gp100, and MAGE-3 will be utilized for dendritic cell transfection. The vaccine will be     administered by intradermal injection in the extremities. Clinical and laboratory toxicities     will be characterized for each study arm. As a secondary objective, this phase I study will     also assess the anti-melanoma immune responses, as well as clinical responses, induced by     vaccination with this dendritic cell-based product.   "
215658|NCT00672555|"     The investigators think, that the treatment of pilonidal sinus with excision and covering of     the defect with a Limberg-flap is a very good treatment option. The investigators are     introducing this treatment for recurrences of this illness in our clinic and want to analyse     the feasibility, the results, the complications and the patients opinion after the treatment.      If the results are good, a prospective randomised study is a further option.   "
215659|NCT00672568|"     The purpose of this study is to evaluate the safety, tolerability and explore the efficacy of     a single intraoperative injection of 4975 in patients undergoing arthroscopic surgery for     rotator cuff repair of the shoulder   "
215731|NCT00673478|"     The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic     exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus     tiotropium qd and salmeterol bid following 4-week treatment periods in patients with chronic     obstructive pulmonary disease (COPD).   "
215660|NCT00672581|"     This study is designed to compare how ZD4054 (Zibotentan) is taken up, how it is broken down     and removed from the body in subjects with liver cirrhosis and hepatic impairment compared to     healthy subjects of a similar age, sex and weight. As for all clinical trials, safety and     tolerability of the drug will be evaluated as well to develop dosing recommendations for     dosing of ZD4054 (Zibotentan) in subjects with varying stages of hepatic impairment.   "
215661|NCT00672594|"     The purpose of this study is to look at blood and tissue samples for changes following the     use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib     malate, is safe and works in men with prostate cancer. Sunitinib malate , also known as     Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors     of intestines and kidney but it is being tested in research studies for use in men with     prostate cancer.   "
215662|NCT00672607|"     To compare the efficacy and safety of Agnucaston tablets with placebo for the treatment of     Premenstrual Syndrome (PMS) and assess if Agnucaston tablets are superior to placebo on     efficacy or not.   "
215663|NCT00672620|"     The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily     (QD), in adults with major depressive disorder.   "
215664|NCT00672633|"     The investigators will conduct a randomized clinical trial to evaluate the efficacy of Lovaza     (formerly known as Omacor) in reducing triglyceride levels in youth ages 10-19 years old     whose baseline triglycerides range from 150 mg/dl to 1000 mg/dl. Seventy subjects will be     recruited at baseline and randomized to the treatment condition, Lovaza 4 grams/day for 6     months or the control condition, a corn oil placebo, 4 tablets a day for 6 months.     Participants in both the treatment and control groups will receive the standard of care,     which is dietary advice to follow a low, refined carbohydrate and low saturated fat diet that     emphasizes increasing intake of fruits and vegetables and eating 2 servings per week of     fishes rich in omega-3 fatty acids, consistent with the American Heart Association     recommendations. The primary outcome will be change in fasting triglycerides from baseline to     3 months. The investigators hypothesize that patients who receive LOVAZA will have     significantly greater reductions in plasma triglyceride levels when compared to patients on     placebo at 3 months.   "
215665|NCT00672646|"     The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by     the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of     AZD1386 to placebo (inactive substance) on pain. A number of patients will instead receive     the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen,     will be allowed if a need for additional painkillers would arise. A number of patients will     receive naproxen as control.   "
215666|NCT00672659|"     The primary objective is to demonstrate whether the addition of pipamperone 5 mg twice daily     (bd) to citalopram, 40 mg daily in patients suffering from MDD will improve the efficacy of     citalopram 40 mg in these patients.      Secondary objectives are to demonstrate whether the addition of pipamperone 5 mg twice daily     (bd) to citalopram, 40 mg daily in patients suffering from MDD:        1. Will increase the rate of resolution of symptoms with citalopram 40 mg.        2. Show the combined product to be safe and tolerable.      Patients are scheduled to receive study medication for eight weeks and a final follow-up     check will be carried out 28 days after completing the study.      All patients will receive active citalopram from baseline and will be randomised to receive     either active pipamperone or a placebo equivalent for eight weeks during which time they will     attend for 6 study visits.   "
215667|NCT00672672|"     The purpose of this study is to determine if the use of autologous platelet gel (APG) on     sternal incision and conduit sites will improve wound healing and decrease the incidence of     infection in patients undergoing coronary artery bypass grafting surgery   "
215668|NCT00672685|"     Epidemiological and fundamental research carried out in recent years has highlighted the role     played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing     age and Alzheimer's disease. In addition, it has been recognized for some years, following     several convergent studies on the prevention of cognitive decline, that nutrition, physical     exercise, cognitive training and social activities play a significant role in the maintenance     of cognitive faculties. At present, there are a number of epidemiological arguments in favour     of a protective role of each of these factors taken in isolation. It can be postulated that a     multi-domain intervention may potentiate the protective role of omega-3 fatty acids.      The main objective of this study is to assess the efficacy of isolated supplementation with     omega-3 fatty acid, an isolated multi-domain intervention (nutrition, physical exercise,     cognitive stimulation, social activities), or their combination on the change of cognitive     functions in frail elderly subjects aged of 70 years and older over 3 years.      Secondary objectives:        -  To assess the efficacy of each treatment strategy on the change of functional capacities          and the prevention of dependency,        -  To study the long-term safety and tolerability of V0137,        -  To study compliance and adhesion to the multi-domain intervention programme,      Ancillary studies :      To assess the impact of an intervention program on brain metabolism in FDG PET (MAPT-NI : :     impact of multidomain intervention on brain metabolism (FDG-PET))        -  To evaluate the impact of preventive strategies (Omega-3 treatment and multidomain          intervention ) of MAPT study on brain atrophy (MRI),        -  To evaluate the presence and density of ß-amyloid in MAPT subjects using AV45 PET scans          (MAPT AV45),        -  To determine if sleep disorders at early stage of Alzheimer 's disease could be          predictive of cognitive decline and used as diagnosis tools (Mapt SLEEP)        -  To evaluate the impact of omega-3 fatty acids on the body composition measured by DXA          scans (MAPT-DXA)   "
215669|NCT00672698|"     The purpose of this study is to establish the surgical risk factors and differences between     different diseases in elderly patients submitted to elective surgery in our institution.   "
215670|NCT00672711|"     The association between the COMT haplotypes and the presence or absence of CPSP or CRPS will     be assessed stratifying the patients based on the individual categories of trauma or elective     surgery.   "
215671|NCT00672724|"     The purpose of this study is to evaluate subjectively reported treatment effects of     ramelteon, once daily (QD), in adults with chronic insomnia.   "
215672|NCT00672737|"     We would like to test the effect of opioid medication on pain sensitivity in subjects who     have been diagnosed with a sleep disorder called Obstructive Sleep Apnea (OSA) compared to     other subjects without OSA. Patients with OSA may have an altered sensitivity to the     sedative, analgesic, and respiratory depressant effects of opioids.   "
215673|NCT00672750|"     This will be a retrospective review of approximately 900 patients who have undergone     laparoscopic myomectomy since 1999. patients will be contacted by phone and surveyed. All     patients who have had laparoscopic myomectomy will be included. Only those not wishing to     take part in the survey will be excluded. The data will then be compiled for statistical     analysis , looking at pain, bleeding and subsequent fertility.   "
215674|NCT00672763|"     The purpose of this study is to determine whether the addition of vitamin D to standard     corticosteroids improves onset of remission in active Crohn's Disease, a form of Inflammatory     Bowel Disease (IBD).   "
215675|NCT00672776|"     Posttraumatic stress disorder (PTSD) is a major public health problem in this country. It is     estimated that at least one out of every seven women in our society have been the victim of     childhood sexual abuse at least once before their 18th birthday. Previous studies have shown     that stress is associated with damage to neurons of the hippocampus, a brain area involved in     learning and memory. Also, imaging studies of brain function are consistent with dysfunction     of the medial prefrontal cortex during presentation of traumatic cues. We have previously     shown that serotonin reuptake inhibitor medications (paroxetine; Paxil) can change memory     function and hippocampal structure in PTSD. We now propose to perform a placebo controlled     study with Paxil CR (paroxetine hydrochloride controlled-release tablets), which is thought     as paroxetine with less side-effects. The main purpose of this study is to determine the     effects of Paxil CR on memory deficits measured with neuropsychological testing, hippocampal     volume measured with a magnetic resonance imaging (MRI), medial prefrontal lobe cortical     function estimated with PET, and cortisol response (reflecting the intensity of stress) in     men and women with PTSD. We plan to recruit 40 subjects. After completing physical     examination and evaluating neuropsychiatric history, patients will undergo an initial group     of tests which includes memory testing, MRI and PET brain scan, and measurement of cortisol     in their saliva. Afterwards, half will receive Paxil CR 12.5 to 62.5 mg and half will receive     a placebo (sugar pill) in the beginning of the first 12 weeks as Double Blind Phase. After     12 weeks, they will be administered memory tests, PET and MRI scan for the post-treatment     phase. After this period, Paxil CR will be offered to the placebo group and followed for an     additional 12 weeks. They will have final memory tests, and a MRI scan. We hypothesize that     Paxil CR exerts its efficacy by acting on abnormal neural circuits, including hippocampus and     prefrontal cortex, in PTSD.   "
215676|NCT00672789|"     Medication non-adherence is a true public health problem. Despite advancements in the     molecular understanding of disease and improvements in therapy, patient health outcomes will     not improve unless patients take prescribed medications regularly. Decreasing the gap between     efficacious and effective therapy for patients with SCD is an essential research agenda.     Hydroxyurea has been shown to be safe and efficacious in children and infants. However, the     effectiveness of the prophylaxis depends on adherence to the recommended regimen. Medication     adherence in SCD has previously been found to be sub-optimal in patients taking penicillin,     desferoxamine, and pain medication. Adherence to HU has been studied to some extent in     children with SCD. Based on estimates of adherence in other chronic illness we expect     approximately 50% of patients to be >80% adherent with their HU administration. There is no     gold standard for improving adherence to treatment. There have been a few attempts in the SCD     population to improve adherence. These include a day camp to promote education about     desferoxamine and peer support, a combination of a slide-show about SCD and it complications,     weekly phone calls by the clinic social worker and a calendar, and a seven-phase educational     program. Given the striking improvements in the peripheral blood smear findings of patients     with SCD on HU therapy, with reduction in the numbers of sickled cells, we hypothesize that     viewing the peripheral blood smear of patients with poor adherence to HU compared to a blood     smear of someone on HU can be used to improve adherence in non-adherent patients.      We will conduct a randomized trial between the intervention of regularly showing children and     their parents the peripheral blood smear and standard care, including reminders of the     importance of compliance and review of complete blood count parameters, including WBC, MCV,     and Hgb concentration. The outcome measures will be increase in hemoglobin concentration and     %HbF and increase in perceived QOL. QOL will be measured with age-appropriate and     parent/proxy PedsQL™. Medication adherence will also be monitored throughout the study with     pharmacy prescription refills, physician assessment, and self-report via a visual analogue     scale. Adherence estimates, hemoglobin concentration, %HbF and QOL will be measured at     baseline, 3 months and 6 months.   "
215677|NCT00672802|"     This purpose of this study is to assess the safety of ramelteon, once daily (QD), in subjects     with chronic obstructive pulmonary disease.   "
215678|NCT00672815|"     The purpose of this study was twofold: 1) to assess awareness of and adherence to Texas SB42     among a representative sample of public middle schools in Texas; and 2) to assess the impact     of SB42 on the frequency of school PE class, the quality of school PE, and prevalence of     child self-reported physical activity behaviors and child overweight along the Texas-Mexico     border.   "
215679|NCT00672828|"     RATIONALE: An interactive computer program may be more effective than a brochure in     increasing colorectal cancer screening among African Americans.      PURPOSE: This randomized clinical trial is studying an interactive computer program to see     how well it works compared with a brochure in increasing colorectal cancer screening among     African Americans.   "
215680|NCT00672841|"     This is a single center, prospective, open label assessment of β-D-glucan surveillance with     preemptive anidulafungin therapy versus standard care for the prevention of invasive     candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be     stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance     using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will     receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single     determination. Subjects in the standard care arm will have biweekly blood draws for     β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in     the standard care arm is at the discretion of the treating physicians. The primary study     end-points are the feasibility of a preemptive antifungal strategy in a SICU setting,     β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin.     Risks associated with study participation include the risks associated with blood draws,     study drug related side effects, and the potential for loss of confidentiality.   "
215681|NCT00672854|"     Many hospitalized patients who are malnourished or not eating receive intravenous feeding or     total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of     infections and hospital complications. We do not know why TPN increases hospital     complications, but it may be caused by the high sugar or fat content in TPN solutions.   "
215682|NCT00672867|"     The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus     Adefovir dipivoxil in patients with LC-B.   "
215683|NCT00672880|"     This study is for people with chronic low back pain who may also be feeling discouraged,     frustrated, or depressed. This study is testing a new therapy that is designed to     specifically help these patients foster a better self-image. We hope this therapy will help     them feel less discouraged and depressed and, possibly, even help reduce their stress enough     that they may feel less pain.   "
215699|NCT00673088|"     The objective of this study was to assess the single dose bioequivalence of Roxane's     Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting     conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over     design.   "
215700|NCT00673101|"     The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers     in patients treated with methotrexate.   "
215732|NCT00673491|"     The purposes of this study are to determine whether clinical pathways: 1)improve the quality     of the care provided to patients affected by stroke in terms of clinical outcomes, efficiency     continuity of care and patients' satisfaction; 2) facilitate the use of evidence based     medicine in clinical practice.   "
215733|NCT00673504|"     Primary objective: to evaluate whether the addition of sunitinib prolongates the     Progression-Free Survival (PFS) in patients with advanced pancreatic cancer receiving     first-line gemcitabine chemotherapy.   "
215911|NCT00677378|"     We would like to evaluate the changes in nerve innervation and TRPV1 receptor expression     along with microscopic changes associated with heart burn and abdominal pain   "
215684|NCT00672893|"     Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the     lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds).     Airflow in the lungs during the respiration cycle creates vibrations that propagate through     the lung tissue; these vibrations are affected by the structural properties of the lungs and     may vary in space, time and frequency. Moreover, any structural alteration, such as a     bronchial obstruction or space occupying infiltration, is reflected in a corresponding     modification of the vibration response.      As obstructions that occur in airways alter airflow, the VRI may provide additional lung     function information prior to treatment for airway obstruction and during follow-up.     Moreover, the VRI may provide the physician immediate evaluation of the improvement of air     flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a     non-invasive, radiation free procedure which is simple and doesn't require the level of     patient effort required for lung function test and other evaluation.   "
215685|NCT00672906|"     While parents are considered essential for the effective treatment of adolescents with     anorexia nervosa, the most effective manner to involve parents in treatment is unknown. Given     reports of high caregiver burden among parents of this clinical group, finding treatments     that minimize parent burden while improving the child's eating disorder symptoms is     essential.      This investigation will examine the preliminary effectiveness of a parent skills group and     adolescent skills group compared to family therapy for the treatment of adolescent anorexia     nervosa. The target of this intervention is the improvement of eating disorder symptoms in     the child and improving self-efficacy, emotion regulation, and perceived burden in the     parent.      The effectiveness of this experimental treatment group (Group Parent Training for the     parents/Adolescent Skills Training for the adolescent) will be compared to the Maudsley model     of family therapy. The effectiveness of the group program will be examined by exploring     changes within individuals over time as well as via comparisons across treatment conditions.     Results from this investigation will be used to calculate treatment effect sizes in the     design of a larger, fully powered, randomized clinical trial.   "
215686|NCT00672919|"     The purpose of this study is to measure the triglyceride changes in subjects with type 2     diabetes mellitus taking pioglitazone, once daily (QD), following treatment conversion from     rosiglitazone.   "
215687|NCT00672932|"     This pilot study focuses on the persistence of central nervous system (CNS) immune activation     that has been observed in the presence of 'effective' combination antiretroviral therapy     (cART). Attention to this issue is based on the fear that chronic CNS immunoactivation can     cause indolent brain injury that will eventually compromise brain function as patients     survive for years on treatment. A leading hypothesis explaining this continued     immunoactivation is that viral replication continues within the brain at a level too low for     detection in cerebrospinal fluid (CSF), yet sufficient to stimulate local immunoactivation.     Based on this hypothesis, we propose to use augmented treatment with raltegravir to test     whether additional suppression of this hypothesized CNS HIV-1 replication will reduce     continued CNS immunoactivation.   "
215688|NCT00672945|"     A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 in subjects with     Alzheimer's Disease receiving a stable dose of donepezil. The study consists of a 26-week     double-blind treatment period.   "
215689|NCT00672958|"     The purpose of this study is to determine the efficacy and safety of once daily vortioxetine     (Lu AA21004) in adults with major depressive disorder.   "
215690|NCT00672971|"     The purpose of this study was to evaluate the efficacy of a dimethicone foam in the control     of head lice and to compare the efficacy to a permethrin based product.   "
215691|NCT00672984|"     To assess the effect of immediate-release guanfacine hydrochloride, administered at     therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females   "
215692|NCT00672997|"     The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness     of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma     or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997)     and Japan (C-08-08, NCT00760539).   "
215693|NCT00673010|"     One of the most effective treatments for metastases from thyroid cancer is a form of     radioactive iodine known as 131-I. For more than 50 years, 131-I has been used to find and     destroy thyroid cancer cells that have spread to other parts of the body. In many cases this     treatment destroys the metastatic cells. However, in some patients it does not appear to work     completely. This study is designed to use a slightly different form of radioactive iodine     (called 124-I) which can precisely predict the amount of radiation that each metastatic     lesion will receive.      124-I was developed at Memorial Sloan-Kettering in the 1950s and has been used here and at     many other medical centers around the world for diagnostic studies. It has been found to be     very safe and effective at finding metastatic lesions. The high resolution of newer PET     scanners now allows us to carefully determine how much radiation each metastatic lesion will     receive. If 124-I can accurately predict which patients will not respond to 131-I treatments     we can then avoid exposing those patients to unnecessary radiation. For the rest of the     patients we can custom tailor the 131-I dose to destroy the metastatic lesions.   "
215694|NCT00673023|"     The purpose of this study is to determine whether plasma lipoproteins and lipid     responsiveness to a dietary modification is influenced by CETP gene polymorphism.   "
215695|NCT00673036|"     The Fast-MI registry was designed to evaluate the real world management of patients with     acute myocardial infarction (MI), and to assess their in-hospital, medium and long-term     outcomes   "
215696|NCT00673049|"     The objective of this study is to test a clinical benefit of the addition of CP 751,871 to     erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The     primary endpoint is Overall Survival (OS).   "
215697|NCT00673062|"     This study is to evaluate the effectiveness of a new drug on congestion in subjects with     seasonal allergic rhinitis. This effect will be compared to placebo and to the decongestant,     pseudoephedrine.   "
215698|NCT00673075|"     This study is being done to see if the blood pressure lowering effect of an approved drug     nebivolol is comparable to that of another approved drug carvedilol for the treatment of     hypertension in patients who have coronary artery disease.   "
251382|NCT01146535|"     This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in     combination with oseltamivir (Tamiflu) to treat influenza.   "
215701|NCT00673114|"     Subjects will be diagnosed with a hematological malignancy (cancer of the blood), which is     unlikely to be cured with conventional non-transplant therapy. The best results of bone     marrow transplant are obtained with the donor is a relative that has identical tissue type     (HLA-type). These subjects will not have such a donor available but they will have a     appropriately matching unrelated umbilical cord blood unit (UCB). However, the cord blood     unit does not contain a high enough number of cells and may take longer to engraft (or grow).     The purpose of this study is to determine whether the addition of stem cells from a family     member to supplement a standard unrelated cord blood transplant is safe and will increase the     success of the cord blood transplantation procedure. Subjects enrolled in this study will     receive an unrelated cord blood transplant plus a haplo-identical (half-matched), T-cell     depleted stem transplant from a related donor. The goal of this study is to determine whether     the addition of the related stem cells accelerates bone marrow recovery and improves     long-term disease free survival.   "
215702|NCT00673127|"     The combination of ketaconazole and hydrocortisone is commonly used for the treatment of     prostate cancer. The purpose of this study is to determine if the addition of a drug called     dutasteride to this approved combination will make the combination more effective in treating     prostate cancer.   "
215703|NCT00673140|"     Amyotrophic Lateral Sclerosis (ALS, sometimes called Lou Gehrig's s Disease, or Maladie de     Charcot) is a progressive, usually fatal, neurodegenerative disease caused by the     degeneration of motor neurons, the nerve cells in the central nervous system that control     voluntary muscle movement.      This study will investigate the use of far infrared radiation for the control, management and     treatment of ALS.   "
215704|NCT00673153|"     RATIONALE: Vorinostat may stop the growth of cancer cells by interfering with various     proteins needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin (GO),     can block cancer growth in different ways. GO finds cancer cells and helps kill them by     carrying a cancer-killing substance to them. Giving vorinostat together with gemtuzumab     ozogamicin may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving vorinostat together with gemtuzumab     ozogamicin works in treating older patients with previously untreated acute myeloid leukemia.   "
215705|NCT00673166|"     We observed in a randomised intervention trial in Bissau that mortality due to malaria could     be reduced by half by adding a small monetary incentive to the staff and strict follow-up of     a standard protocol for available drugs. The Government and donors are not able to sustain     such incentives. We intend to evaluate whether strict organisation of a cost recovery system     and the use of part of the funds for staff incentives would improve performance of the staff     and contribute to reduction of hospital and post-discharge mortality.   "
215706|NCT00673179|"     The goal of this clinical research study is to learn if giving certain combinations of     chemotherapy drugs before and after surgery, mostly in the outpatient clinic instead of in     the hospital, can result in fewer hospital stays during treatment for osteosarcoma. The drugs     and schedules will vary depending on the status of the cancer and its level of risk for     spreading, but they will include combinations of doxorubicin (non-liposomal), cisplatin,     methotrexate, and ifosfamide, as described below.   "
215707|NCT00673192|"     Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of     the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women     worldwide dying of cervical cancer each year. Human papilloma viruses (HPV) have been     consistently implicated in causing cervical cancer especially those high-risk types (HPV     16,18,31,45) have been strongly associated with cervical cancer. Around 50-80 % of women are     infected by HPV within their whole lives. However, only 1% of HPV-infected women have     cervical cancer eventually. Seventy and 91% of HPV infection could be cleaned up by host     immune responses within 1 and 2 years later. It shows that host immunity plays an important     role in the progression, persistence, or regression of HPV infection.      There are two main defense lines in the host immunity including innate immunity and adoptive     immunity. Adoptive immunity plays more important roles in the defense of HPV infections than     innate immunity. The adoptive immunity could be further divided into humoral immunity and     cell-mediated immunity. Humoral immunity regulated by Th2 helper T lymphocytes to generate     memory B cells to produce antibody which provide the protective function to HPV infection.     Cell-mediated immunity regulated by Th1 helper T lymphocytes to induce antigen-specific     cytotoxic T cells which could kill the HPV-infected cells. Although there are many researches     focused on the immunity to HPV infection, there is no conclusion about the relationship     between humoral and cell-mediated immunities on HPV infection and roles of humoral and     cell-mediated immunities in the prognosis of HPV-infected population and cervical cancer     patients.      Our research team has focused on the establishment of platforms on cell-mediated immunity to     HPV infection and on the correlation of cell-mediated immunity and prognosis of HPV-infected     population and cervical cancer patients for years. In order to survey the host immunity to     HPV infection more comprehensively, we propose this proposal. First, we would like to set up     the platforms to elucidate the humoral immunity to HPV infection in normal population and     patients with CIN lesion or cervical cancer. Second, we would to survey the correlation     betweem humoral immunity and status and clinico-pathologic items of HPV-infected populations.     Our research results will have a more comprehensive overview in the host immunity to HPV     infection and its related diseases. It could provide more information in the prevention and     treatment of HPV infection in the future.   "
215708|NCT00673205|"     The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy,     versus placebo, in subjects who have either undergone a primary therapy (principally radical     prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.   "
215709|NCT00673218|"     If you are allergic to ragweed, and not taking certain medications, you will be asked to have     blood drawn. We will perform experiments on your blood cells.   "
215710|NCT00673231|"     This study is being carried out to see if Dapagliflozin in addition to insulin is effective     and safe in treating patients with type 2 diabetes when compared to placebo (identical     looking inactive treatment) in addition to insulin   "
215711|NCT00673244|"     The principal objective is to safely determine if we can identify the severity of Acute     Kidney Injury (AKI) early in the course of the disease. Once enrolled, we will draw blood and     urine for relevant biomarkers. Our goal is to validate if any of these biomarkers can predict     the course of AKI (recovery v. RRT v. death)   "
215712|NCT00673257|"     RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the     laboratory may help doctors learn more about how patients respond to treatment with certain     chemotherapy drugs.      PURPOSE: This laboratory study is looking at the pharmacokinetics of daunorubicin in treating     young patients with cancer.   "
215713|NCT00673270|"     Septic shock (associated with relative adrenal insufficiency) is characterized by decreased     arterial responsiveness to catecholamines. The association of hydrocortisone and     fludrocortisone has demonstrated an improvement in survival in septic shock patients. If     hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone     remains to be elucidated. The purpose of our study is to investigate the effect of a     physiological dose of fludrocortisone and/or hydrocortisone on phenylephrine-mean arterial     pressure dose-response relationship in healthy volunteers with aldosterone suppression     induced by intravenous sodium loading.   "
215714|NCT00673283|"     This project proposes a new method, Bi-plane Correlation Imaging (BCI), for improved     detection of subtle lung nodules. In BCI, two digital radiographs of the chest are acquired     within a short time interval from slightly different posterior projections. The image data     are incorporated into an enhanced Computer-aided Diagnosis (CAD) algorithm in which nodules     present in the thoracic cavity are detected by examining the geometrical correlation of the     detected signals in the two views. The data are alos viewed stereoscopically for visual     diagnosis. The expected high sensitivity/specificity of the method has the potential to     change the current state of practice, perhaps leading to a preventive lung cancer screening     program for high-risk populations, similar to the mammography screening program currently in     place for breast cancer.   "
215715|NCT00673296|"     Diabetic premacular hemorrhage occurs when blood from preretinal neovascular tissue is     entrapped between the retina and the posterior hyaloid in the macular area. It may occur     spontaneously or secondary to traction from a localized posterior vitreous detachment. This     complication may greatly disturb the central vision and may be an important stimulant of     fibrovascular proliferation.      Bevacizumab (Avastin, Genentech, Inc.) is a humanized monoclonal antibody against vascular     endothelial growth factor (VEGF), which has been used to treat a variety of neovascular     ocular diseases. In proliferative diabetic retinopathy, intravitreal bevacizumab has been     shown to induce prompt regression of neovascularization and may enhance resolution of     vitreous hemorrhage.      In this study, we propose that simultaneous intravitreal injection of gas and bevacizumab may     be a useful treatment option in diabetic premacular hemorrhage with active fibrovascular     tissue. In this procedure, gas is used to displace the blood while bevacizumab may render the     neovascularization less active to decrease the likelihood of recurrent hemorrhage.   "
215716|NCT00673309|"     The purpose of this study is to find ways to improve wound healing and decrease the negative     effects of trauma from burn injury.   "
215717|NCT00673322|"     The purpose of this study is to collect data on the safety and effectiveness of 2nd     generation designer T cells in patients with colorectal cancer. Designer T cells are prepared     by collecting white blood cells from the participant, and then modifying these cells in the     laboratory so that they recognize the tumor antigen (CEA). These modified cells are then     given back into the participant so that they can attack and kill tumor cells.   "
215718|NCT00673335|"     RATIONALE: Letrozole may prevent breast cancer in postmenopausal women with a BRCA1 or BRCA2     mutation.      PURPOSE: This randomized phase III trial is studying letrozole to see how well it works     compared with a placebo in preventing breast cancer in postmenopausal women with a BRCA1 or     BRCA2 mutation.   "
215719|NCT00673348|"     Voriconazole (VCZ), the antifungal drug active against Candida and Aspergillus is a substrate     of CYP2C19, whose proportion of poor metabolizers is about ~20% in Asian population. The     AUC's of VCZ differs over 4 folds by CYP2C19 genotypes of homozygotic wild type,     heterozygote, and homozygotic poor metabolizers. The Asian population enrolled in the     metabolism of VCZ were mainly Japanese and Chinese, without Korean subjects. The proportion     of poor metabolizers in Korean population is known to be around 12% (Pharmacogenetics. 1996     Dec;6(6):547-51). The importance of CYP2C19 genotypes on the pharmacokinetics (PK) of     voriconazole is well established, Hence, it is desirable to individualize the dosage regimen     of VCZ according to the genotypes of patients. Fungal infection in immunocompromised patients     is a life threatening condition which needs critical care. Although the PK change by     genotypes are well known, its clinical implication or need for different dosage regimen by     genotypes is not established, yet.   "
215720|NCT00673361|"     This research study is testing the chemo-switch strategy in melanoma, using biochemotherapy     initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide)     together with sorafenib. The purpose of this study is to find out what effects (good and bad)     biochemotherapy followed by temozolomide plus sorafenib have on melanoma.   "
215721|NCT00667498|"     The primary objective of this randomized, parallel group, double-blind, placebo-controlled     study is to determine whether treatment with metformin enhances insulin sensitivity in a     group of ethnically diverse obese insulin-resistant adolescents with normal glucose     tolerance.   "
215722|NCT00667511|"     The purpose of this study is to determine whether or not nocturnal hemodialysis is equivalent     to short daily hemodialysis on a per treatment basis, using the NxStage System One in the     home setting.   "
215723|NCT00673374|"     To determine the correlation between the region of abdominal tenderness determined by the     examining physician and the location of acute pathology diagnosed on abdominal CT. We     hypothesize that the acute pathology diagnosed by CT will lie within the region marked on the     abdominal wall by the examining physician prior to CT.   "
215724|NCT00673387|"     A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety,     tolerability and effect on body weight of a range of doses of metreleptin and pramlintide,     each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.   "
215725|NCT00673400|"     The stapled transanal rectal resection (STARR procedure) is an effective treatment for     obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new     technique has been developed using the new Contour® TranstarTM stapler, which was     specifically designed to facilitate the STARR procedure. The investigators would like to     evaluate the morbidity and quality of life.   "
215726|NCT00673413|"     The present work had as purpose to analyze estomy-individuals according to the feelings of     their current situation.   "
215727|NCT00673426|"     The purpose of this study was to evaluate safety, not inferiority clinical and     pharmacodynamic profile of the drug Enoxaparin Sodium produced by laboratory Blausiegel when     compared with Clexane product, produced by Laboratory Sanofi-Aventis in 60 patients with     Chronic Renal Desease.   "
215728|NCT00673439|"     The purpose of this study is to determine how safe and effective fondaparinux is in treating     patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).   "
215729|NCT00673452|"     The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once     daily in comparison to placebo on symptom improvement in patients meeting criteria for     fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo,     however, all patients will receive duloxetine at some point in the study.   "
215734|NCT00673517|"     Although mechanical ventilation is life saving, it is associated with a number of severe     complications collectively referred to as ventilator induced lung injury (VILI). VILI     contributes to the high morbidity and mortality associated with the acute respiratory     distress syndrome (ARDS). Within the context of a randomized study evaluating the feasibility     of conducting a study comparing high frequency oscillation to conventional lung protective     ventilation in early severe ARDS, we are evaluating the effect of both ventilator strategies     on biological markers of VILI.   "
215735|NCT00673530|"     The purpose of this study is to determine whether there is a positive correlation between an     evidence based clinical nutrition concept and relevant clinical outcomes in malnourished     hospitalised patients when severity of disease is adjusted.   "
215736|NCT00673543|"     Preterm birth occurs in 25% of women with insulin requiring diabetes in pregnancy. The     administration of corticosteroid therapy to accelerate fetal lung maturation is indicated in     women at risk for preterm birth. The purpose of this study is to compare the timing, duration     and severity of maternal hyperglycemia after corticosteroid administration in women with     insulin-requiring diabetes compared to those without diabetes in pregnancy.      This is a prospective, observational study. Hourly glucose levels will be obtained for a     total of 7 days after corticosteroid administration using the Dexcom Seven continuous glucose     monitoring system. In addition, hemoglobin A1C will be obtained to assess the overall level     of glycemic control of the participant prior to the corticosteroid therapy.   "
215737|NCT00673556|"     To assess the efficacy and safety of Alefacept compared to placebo for the treatment of     Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and     inappropriate   "
215738|NCT00673569|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that may occur in DNA and identify biomarkers related     to cancer. It may also help doctors learn how well patients will respond to treatment.      PURPOSE: This phase II trial is studying how well a laboratory test predicts response to     erlotinib in patients with metastatic or unresectable non-small cell lung cancer that did not     respond to previous treatment.   "
215739|NCT00673582|"     Rosuvastatin is a drug used to lower cholesterol, which also has other cardiovascular     benefits. The goal of this project is to determine if rosuvastatin is effective at slowing     the development of heart disease in people with HIV. We expect that after 2 years of     treatment people treated with rosuvastatin will show significantly better results than people     treated with a placebo.   "
215740|NCT00673595|"     The purpose of this study is to evaluate endothelial function and autonomic regulation (for     example, heart rate and blood pressure) in smokers before and after short-term smoking     cessation. The endothelium is the thin layer of cells that lines the interior surface of     blood vessels. The endothelium releases nitric oxide, which promotes dilation of the blood     vessels and inhibits inflammation. Previous studies have shown that tobacco use is associated     with endothelial dysfunction, and tobacco use increases heart rate and blood pressure.      We hypothesize that 2 weeks of smoking cessation will improve endothelial function. We will     also determine if endothelial function and autonomic regulation after short-term smoking     cessation differs for patients that achieve abstinence with the smoking cessation agent     varenicline compared to placebo.   "
215741|NCT00673608|"     This study will evaluate the change in cardiac iron load over a 53 week period measured by     MRI in 2 cohorts of patients   "
215742|NCT00673621|"     This study will compare the rate and extent of absorption of TI Inhalation Powder in subjects     with asthma and subjects with normal lung function. 24 eligible subjects will be enrolled     into the treatment phase of the trial.   "
215743|NCT00673634|"     The purpose of this clinical trial is to evaluate whether pre-oxygenation of obese patients     with BiPAP 4cm H2O, renders any benefit to the quality of pre-oxygenation measured by the     expired oxygen fraction (FeO2) and whether it is as well tolerated as the traditional method     of spontaneous breathing for 3 minutes.   "
215744|NCT00673647|"     The purpose of this study is to evaluate the effectiveness of the cognitive-behavioral     treatment program CANDIS among n=450 patients with cannabis use disorders in a mulicenter     randomized-controlled clinical trial (n=11 outpatient treatment centers).   "
215745|NCT00673660|"     The purpose of the study is to show the compliance rates of the patients to statin treatment     and the reasons of non-compliance.   "
215746|NCT00673673|"     This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of     FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or     unresectable gastroesophageal and gastric adenocarcinoma. Our primary objective is to     determine the time to progression in patients treated with FOLFOX in combination with     bevacizumab.   "
215747|NCT00673686|"     In this study a comparison was made on the influence of missing pills on follicular ripening.     By missing a given number of pills, an effect on contraceptive robustness of the two     investigated contraceptive pills was measured by ultrasound comparison of follicular size and     other parameters which indicate how far ovulation might be.   "
215748|NCT00673699|"     The purpose of this study is to determine if endoscope with NBI(narrow banding imaging)can     detect intestinal metaplasia( consider pre malignant condition) and use a targeting biopsy in     case of suspected intestinal metaplasia   "
215784|NCT00675701|"     This is a Phase 1, double-blind, randomized, repeat-dose, single -dite, 4-arm parallel group     study to define the ECG effect of lixivaptan using a therapeutic and supratherapeutic dose     compared to placebo and moxifloxacin (a positive control in healthy adult men and women.   "
215750|NCT00675246|"     This study aims to determine the effectiveness of antenatal corticosteroid therapy in late     preterm babies. The investigators hypothesis is corticoid accelerates fetal lung maturation     even after 34 weeks and reduces risk of respiratory distress syndrome and other neonatal     morbidities.   "
215787|NCT00675740|"     The aim of this study is to prospectively assess the relative benefits of either treatment     with rosiglitazone or physical exercise on endothelial function in patients with impaired     fasting glucose or impaired glucose tolerance and coronary artery disease (CAD).   "
215813|NCT00676091|"     The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy     infants in Brazil for safety and tolerability, and to determine the immune response to the     vaccines.   "
215751|NCT00675259|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation and carboplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some find tumor cells and help kill     them or carry tumor-killing substances to them. Others interfere with the ability of tumor     cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking     blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel     albumin-stabilized nanoparticle formulation and carboplatin together with bevacizumab works     in treating women undergoing surgery for stage II or stage III breast cancer.   "
215752|NCT00675272|"     Brain death patients who are selected for organ donation very often suffer from haemodynamic     instability. To treat this, high amounts of vasoactive drugs(norepinephrine) may be needed to     raise blood pressure. However,norepinephrine may have negative influence on several organs     causing reduced blood flow ischemia. Our hypothesis is that hydrocortisone treatment may     reduce the amount of vasoactive drugs needed to keep the blood pressure stable in patients     selected for organ donation.   "
215753|NCT00675285|"     Leukotriene receptor antagonists (LTRAs) reduce fractional exhaled nitric oxide (FENO)     concentrations in children with asthma, but the effect of LTRA withdrawal on FENO and lung     function is unknown. We will aim to study the effect of treatment and withdrawal of     montelukast, a LTRA, on airway inflammation as reflected by FENO and lung function in     children with asthma.      A double-blind, randomized, placebo controlled, parallel group study will be undertaken in 18     atopic children with mild persistent asthma who will be treated with oral montelukast (5     mg/day for 4 weeks) and 18 atopic children with mild persistent asthma who will receive     matching placebo.      A follow-up visit will be performed 2 weeks after montelukast or placebo withdrawal.   "
215754|NCT00675298|"     Urologic pelvic pain syndrome (UCPPS), variably termed painful bladder syndrome/interstitial     cystitis (PBS/IC) in females and chronic prostatitis/chronic pelvic pain syndrome in men     (CP/CPPS), is a chronic, debilitating clinical syndrome presenting as severe pelvic pain with     extreme urinary urgency and frequency in the absence of any known cause. The etiologic     mechanisms underlying UCPPS are unknown, but recurrence, risks to siblings of affected     individuals, concordance among monozygotic twins, and our own preliminary studies indicate a     strong genetic contribution to the cause of UCPPS. The overall goal of this proposal is use     novel approaches to understand the basis of UCPPS, to identify candidate genes containing     mutations that result in UCPPS and determine how the different encoded proteins of these     genes interact with one another in a common biological pathway. Ultimately, understanding how     mutations in at least five different genes yield the symptoms of UCPPS should lead to     improved diagnosis and possible therapies.   "
215755|NCT00675311|"     The primary objective of this study is to determine whether remote monitoring in diabetes     management is more effective at helping patients manage their disease than a standard disease     management program.   "
215756|NCT00675324|"     Bowel preparation can be a troublesome procedure for patients undergoing colonoscopy. For     patients with cardio-vascular and kidney disorders it may be dangerous with traditional bowel     preparation with regard to salt and electrolyte balance. This study's purpose is to find out     if nutritional drinks can replace traditional bowel preparation before colonoscopy in regard     to Bowel purity degree, disturbances in the salt and electrolyte balance in the nutritional     group versus the group that gets traditional bowel preparation. And if the patients tolerate     nutritional drinks better than traditional bowel preparation.   "
215757|NCT00675337|"     This is a pilot study designed to assess the safety of placing an infant on the mother's     abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of     placing the infant on the mother's abdomen on the infant's iron stores. It is possible that     placing the infant on the mother's abdomen (above the placenta) may lower the infant's iron     stores during early infancy.   "
215758|NCT00675350|"     PK Study of Homoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to     Patients With Advanced Solid and Hematologic Tumors   "
215759|NCT00675363|"     The purpose of this study is to determine whether the use of both a nurse-driven sedation     protocol and daily sedative interruption, compared with a sedation protocol alone, result in     better outcomes for mechanically ventilated adults.   "
215760|NCT00675376|"     Most people undergoing lung transplantation have chronic obstructive pulmonary disease     (COPD), a disease in which the lung airways are partly damaged and obstructed, making it     difficult to breathe. This study will enroll people with COPD who are undergoing a lung     transplant to examine how their quality of life changes after the transplant procedure.   "
215770|NCT00675506|"     Obesity, a condition that occurs when a person has too much body fat, affects about 31% of     people in the United States. It is associated with increased risk of diabetes, high blood     pressure, high cholesterol, and cardiovascular disease. Abdominal obesity, in particular, is     also associated with low levels of growth hormone, a hormone that affects rate of growth and     the way the body uses energy. Growth hormone releasing hormone (GHRH) is a substance that     makes the body naturally increase its own growth hormone levels. Administering GHRH to people     who are obese may help return their growth hormone levels to normal and, in turn, may lead to     reduced abdominal fat and improved cardiovascular function. This study will evaluate the     effectiveness of synthetic GHRH in decreasing the amount of abdominal fat and improving     cardiovascular function in people who are obese.   "
215797|NCT00675870|"     The purpose of this study is to determine whether NRX 195183 is effective in the treatment of     relapsed or refractory Acute Promyelocytic Leukemia   "
215798|NCT00675883|"     A phase IV, observational, survey-based study to measure compliance with Avonex® PS therapy     in patients with Relapsing-Remitting Multiple Sclerosis, and to compare persistence on     therapy 22 months after initial prescription of AVONEX® PS between patients enrolled in the     current MS AllianceTM program versus patients enrolled in this program prior to October 2007.   "
216129|NCT00680628|"     The purpose of this study is to determine if tenecteplase plus enoxaparin is safe and     effective in the treatment of patients with severe submassive pulmonary embolism.   "
215761|NCT00675389|"     The provision of antiretroviral therapy (ART) in rural, resource-limited settings entails     substantial challenges due to limitations in the health service infrastructure and in human     resources for HIV/AIDS care. In addition, long geographical distances between providers, care     facilities, and patients can represent a significant barrier to appropriate and timely care.     The use of peer health workers as frontline adherence supporters and clinical monitors in     order to improve care in underserviced settings has been implemented by a number of programs,     but the effect of peer support on HIV care outcomes has not been extensively evaluated.     Mobile phones have also been proposed as a potential method of improving access to health     care in resource-limited environments by expediting communication and data transfer, but     rigorous studies on their effectiveness in Africa have not yet been conducted.      The Rakai Health Science Project (RHSP) was founded in 1987 to study the HIV epidemic in the     rural setting of Rakai District in southwest Uganda. Since June 2004, the US President's Plan     for AIDS Relief (PEPFAR) has enabled the RHSP to provide ART through a community-based     distribution system which includes clinical monitoring via a decentralized, mobile clinic     approach. By late 2006, the program has screened 4,397 HIV-infected individuals and initiated     ART in 849 patients. One of the challenges of providing ART in this setting has been the     distance between many patients' homes and the clinic and medical staff trained in HIV care.     This distance and the lack of communication channels make frequent clinic contacts difficult     and has raised concerns about adherence and management of drug toxicity. This study will     investigate whether peer health workers can help support this AIDS care program and improve     patient outcomes.      This study is a three armed, community-randomized operations research trial to assess the     effectiveness of peer health workers, with and without mobile phones, in improving the     delivery of HIV care in the resource-limited Rakai setting. The three arms will be: a)     communities with peer health workers, b) communities with peer health workers and mobile     phones, and c) control communities without peer health workers.      Study hypotheses include:        -  Peer health workers, by supporting adherence and by managing simple clinical issues,          will reduce virologic treatment failure and improve ARV adherence compared to patients          in communities without peer educators.        -  Mobile phone technology used by peer health workers, by more rapidly addressing          adherence and clinical problems, will reduce treatment failure and improve adherence          compared to patients in communities with peer health workers without mobile phones.   "
215762|NCT00675402|"     Given that previous studies demonstrated the feasibility of the required MRI techniques, we     propose to study the macro- and microvascular adaptations in PAOD patients undergoing     supervised exercise therapy. It is expected to provide valuable insights into the     contribution of each vascular mechanism to the rehabilitation and to identify which vascular     mechanism fails or is insufficient for a successful rehabilitation. Improvement of future     treatment requires the identification of relevant adaptive mechanisms. With this we will     provide early noninvasive MRI readout tools to diagnose and monitor the potential     rehabilitation during any form of therapy for PAOD that affects the peripheral vasculature.   "
215763|NCT00675415|"     Subjects undergoing elective ERCP and EUS will receive standard monitoring and sedation. In     addition, capnography which measures carbon dioxide levels and can graphically assess     respiratory activity will be used. Subjects will be randomized to either a capnography     blinded or titration arm. In the capnography titration arm, the endoscopy team would be made     aware of capnographic abnormalities as they arise throughout the procedure. In the     capnography blinded arm, this information will not be available to the endoscopy team and     represents standard of care. It is our hypothesis that using capnography can prevent low     oxygen levels known as hypoxemia, during these procedures.   "
215764|NCT00675428|"     The primary objectives of the study are to evaluate the safety profile and the anti-tumor     activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple     myeloma. Secondary objectives are to assess the pharmacokinetic (PK) profile of natalizumab     in this study population and to assess peripheral blood mononuclear cell (PBMC) saturation of     very late antigen-4 (VLA-4, an α4-integrin) and evaluate possible correlations with clinical     activity.   "
215765|NCT00675441|"     The goal of this clinical research study is to learn if Revlimid® (lenalidomide), along with     standard-of-care steroid treatment you are already receiving, can help to control Chronic     Graft-Versus-Host Disease (cGVHD). The safety of this study drug in combination with the     steroids will also be studied.      Primary Objectives:        -  To assess the response rate of chronic GVHD to Lenalidomide after failing steroids        -  To evaluate the safety and tolerability of Lenalidomide in patients with chronic GVHD      Secondary Objectives:        -  To assess the steroid-sparing capacity of Lenalidomide (as proportion of patients able          to discontinue steroids while receiving or following therapy with Lenalidomide)        -  To assess changes in QOL after treatment with Lenalidomide        -  To analyze survival at 6 and 12 months after initiation of Lenalidomide        -  To evaluate relapse of underlying malignancy as well as second malignancies at 6 and 12          months after initiation of Lenalidomide   "
215766|NCT00675454|"     Emphysema is a lung disease that involves damage to the air sacs in the lungs and can lead to     breathing difficulties. Treatment options for people with emphysema include pulmonary     rehabilitation, lung volume reduction surgery, and lung transplantation. This study will     observe people with emphysema to assess the effect of these treatment therapies on their     quality of life and long-term health.   "
215767|NCT00675467|"     The goal of this study is to learn about the communication, decision-making, symptom     management, emotional adjustment, and spiritual needs of parents and pediatric patients     treated at the Children's Cancer Hospital at M. D. Anderson (MCACC).      Primary Objectives:        1. Determine the palliative care service needs of pediatric cancer patients and their          parents, including communication, decision-making, symptom management, emotional and          spiritual support when receiving treatment for early cancer, treatment for advanced          disease, and treatment in the end-of-life period.        2. Identify intra-group differences in the categories listed in Objective 1 for pediatric          cancer patients receiving treatment (a) for early cancer, (b) for advanced disease, and          (c) at end-of-life.      Secondary Objectives:      1. Inform the development of a Pediatric Palliative Care Program at the Children's Cancer     Hospital at The University of Texas M. D. Anderson Cancer Center (MCACC or MDACC) based on     identified needs as determined by primary study aims 1 and 2.   "
215768|NCT00675480|"     The purpose of the study is to determine whether thrombus removal with aspiration     thrombectomy for acute myocardial infarction reduces the infarct size.   "
215769|NCT00675493|"     This trial is conducted in Europe. The aim of this observational study is to evaluate the     blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes     under normal clinical practice conditions in Romania.   "
215771|NCT00675519|"     Compared with control participants at post-intervention follow-ups, unhealthy drinkers who     receive the screening and brief intervention will (1) report reduced alcohol consumption     among all patients, and (2) report reduced alcohol-related problems and health care     utilization.   "
215785|NCT00675714|"     The purpose of the program is to study and characterize the outcome of burn injury with     particular attention to improving the rehabilitation of burn survivors, including children.     Various agents are assessed for effectiveness on long term burn outcome, such as growth     hormone, oxandrolone, propranolol,ketoconazole, inhospital exercise and home exercise.   "
215772|NCT00675532|"     In opioid dependent patients treated with long-acting injectable naltrexone (Vivitrol ®), we     will compare the efficacy of a primary care model of counseling (Condition 1) versus     individualized cognitive-behavioral psychotherapy (Condition 2) for the treatment of opioid     dependence. Treatment will last 12 weeks, and participants will be given 380mg of naltrexone     per injection (3 injections in total; each lasting 4 weeks). Primary outcomes will be 1)     percent of opioid negative urines and 2) treatment compliance as measured by attendance and     time in treatment. Secondary outcomes are opiate craving, opiate withdrawal symptoms,     perceived stress scores, severity of addiction problems, and patient satisfaction. Findings     will elucidate whether injectable, long-acting naltrexone would be safe and effective in a     primary care setting where medication would be administered in the absence of traditional     cognitive-behavioral psychotherapy and indicate whether cognitive-behavioral psychotherapy     adds to treatment effects above and beyond primary care counseling. If positive, this small     controlled study will provide effect size estimates for a larger trial to assess Vivitrol ®     in a primary care setting.   "
215773|NCT00675545|"     The primary objective is to determine the efficacy of docetaxel plus carboplatin as first     line treatment in patients with hormone refractory prostate cancer.   "
215774|NCT00675558|"     Despite progress in understanding the pathophysiology of obesity, current strategies for its     medical management remain largely ineffective. Most efforts have focused on reducing caloric     intake or increasing energy expenditure, either through behavior modification (e.g. dieting,     regular exercise) alone, or augmented by pharmacologic efforts to decrease appetite, inhibit     fat absorption, or alter metabolism. Bariatric surgery remains the only proven long term     treatment of morbid obesity.      Super morbidly obese (SMO: Body Mass Index (BMI) > 50) and super super morbidly obese (SSMO:     BMI > 60) patients lose considerable weight, but stabilize at Body Mass Indexes (BMIs) that     are still obese or even morbidly obese after risking considerable morbidity and/or mortality.     Among commonly performed bariatric surgeries, a laparoscopic two-stage procedure, in which an     initial restrictive procedure is followed after a weight loss of ~100 lbs by a more complex     procedure that creates malabsorption, is gaining interest. Initial studies have demonstrated     very good long-term weight loss with minimal morbidity, and no operative mortality in these     high risk patients.      Availability of biospecimens obtained at each stage of this protocol will allow participating     scientists a unique opportunity to test in human tissues hypotheses developed in animals.     Studies proposed under this application focus on fatty acids and overall fat disposition in     fat depots (adipose tissue) of your body, and the role of adipose tissue hormones and     inflammatory processes in obesity and its associated health related issues.   "
215775|NCT00675584|"     Asthma affects about 4 million children in the United States and is a leading cause of     hospitalizations and school absenteeism. Continuous wheezing in very young children may     develop into asthma. Low doses of inhaled corticosteroids (ICS) are commonly prescribed to     treat children with particularly bad wheezing episodes. This study will compare the safety     and effectiveness of low doses of ICS taken daily versus higher doses of ICS taken only     during respiratory tract illnesses for toddlers with continuous wheezing or coughing     illnesses.   "
215776|NCT00675597|"     The purpose of this study is to determine whether a combination of the drugs docetaxel     (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than     cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients.      Another purpose of this study is to determine whether a third drug, bevacizumab (Avastin®),     may be delivered safely with docetaxel plus vinorelbine in patients who are eligible to     receive bevacizumab.   "
215777|NCT00675610|"     The goal of this research is to improve communication between the patients with HIV and their     health care providers. The overall purpose of doing so is to reduce disparities in medication     self-efficacy, adherence to therapy, and HIV viral load suppression. The investigators will     conduct a randomized controlled trial to test the effectiveness of a combined provider and     patient communication intervention conducted at two separate visits compared to usual care in     improving the quality of patient-provider communication, patients' medication self-efficacy,     patient adherence to therapy, and HIV RNA suppression.   "
215778|NCT00675623|"     The Connection Study is a six-month confirmatory Phase 3 study to determine the safety and     efficacy of Dimebon in the treatment of mild-to-moderate Alzheimer's disease (AD).   "
215779|NCT00675636|"     RATIONALE: Gathering medical and family history information from patients and family members     may help doctors better understand hereditary colorectal cancer and hereditary polyposis     syndrome and identify patients at high risk of developing hereditary colorectal cancer.      PURPOSE: This research study is collecting information from patients and family members with     hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing     hereditary colorectal cancer.   "
215780|NCT00675649|"     The purpose of this study is to assess the safety and effects (good and bad) of golimumab     therapy in patients with severe, persistent asthma.   "
215781|NCT00675662|"     Randomised controlled trial of a lifestyle intervention programme for mothers and children     aged 1-5 years aimed at prevention of overweight and obesity.   "
215782|NCT00675675|"     The study aims to clarify the functional anatomy of key brain circuits associated with     cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare     and contrast hypothesized mechanisms related to increased tic control associated with Habit     Reversal Training, a behavioral treatment that been previously shown to be effective in     treating CTD. We also seek to better understand the relationship between fMRI and     quantitative EEG in relevant brain circuits with the hope of establishing EEG as a valid and     cost-effective marker of treatment responsiveness. A total of 25 subjects will be randomized     to 10 weeks of Habit Reversal Training (HRT), a behavioral treatment, and 25 to 10 weeks of     minimal-contact waitlist. Treatment responders will be re-assessed at three months. Waitlist     nonresponders will be provided with 10 weeks of HRT. Study assessments, including a     neurocognitive battery and quantitative EEG will be administered at baseline, Wk 5, Wk 10,     and 3-month follow-up. Neuroimaging (fMRI) will be conducted at baseline and Wk 10.   "
215783|NCT00675688|"     The purpose of this study is to determine whether bazedoxifene/conjugated estrogens     combinations are effective for the prevention of endometrial hyperplasia and for the     prevention of osteoporosis in postmenopausal women.   "
215788|NCT00675753|"     A multilocus interaction of three pro-inflammatory cytokine single nucleotide polymorphisms     (SNPs), -3448 Tumor Necrosis Factor-α, -7227 Interleukin 6, and 33314 Interleukin 6R was     reported by Menon and associates in 2006. The researchers reported that they were able to     predict spontaneous preterm birth in 65.2% of a population restricted to European-American     mothers. Expansion of this research is needed to determine if the results are also applicable     in Black populations.      Statement of Purpose The purpose of this research is to determine if the multi-locus genetic     interaction of tumor necrosis factor-α (-3448), interleukin 6 (-7227), and interleukin 6R     (33314), as described by Menon et al. (2006), is associated with preterm birth in Black     mother-infant dyads.      Research Aims and Hypotheses:      Primary Aim 1.0: To determine if carriage of one of the high risk genetic patterns, as     identified by Menon et al. (2006), is present in 65% of Black mothers with preterm births and     35% of Black mothers with term births.      Hypothesis 1.0: There is no statistically significant difference in the occurrence of one of     the eight high risk genetic patterns, as identified by Menon et al. (2006), in a population     of Black mothers with preterm births (case) and Black mothers with term births (controls).      Primary Aim 2.0: To determine if carriage of one of the high risk genetic patterns, as     identified by Menon et al. (2006), is present in 65% of Black preterm newborns and 35% of     Black term newborns.      Hypothesis 2.0: There is no statistically significant difference in the occurrence of one of     the eight high risk genetic patterns, as identified by Menon et al. (2006), in a population     of Black preterm newborns (case) and Black term newborns (controls).   "
215789|NCT00675766|"     While the numbers of HIV infected veterans under the age of 50 are declining, the percentage     of HIV infected veterans over the age of 50 is increasing with the largest percentage     increases in the 50-59 age group and the 70+ age group. With increasing incidence rates of     new cases among individuals over 50 years of age and the longer life expectancies of the     current HIV-infected population, it becomes increasingly important to better understand the     impact of the aging process on the clinical and behavioral manifestations of HIV/AIDS.      The project seeks to determine the effect of age on neuropsychological performance in HIV+     persons. This objective seeks to determine the degree to which older age represents an     independent risk factor for neuropsychological impairment in HIV infected persons, with a     particular emphasis on those cognitive processes that are preferentially impacted by both the     normal aging process as well as HIV infection. Additionally, another aim of the study is to     determine the impact of neuropsychological decline on everyday functional abilities among     older vs. younger HIV+ adults. This objective seeks to determine the effects of advancing age     and neuropsychological impairment on the ability of HIV+ persons to discharge more demanding     requirements of independent living (e.g., driving, financial management, medication     adherence). The project will last for a duration of 5 years.   "
215790|NCT00675779|"     The purpose of this study is to determine whether atorvastatin (alone or in combination with     oral contraceptive) is effective in treatment of pelvic pain and inflammatory response in     women with endometriosis.   "
215791|NCT00675792|"     The primary purpose of this study is to compare the incidence of      residual neuromuscular blockade at the time of tracheal extubation after reversal of     rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg     neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch     (T4/T1) ratio of      < 0.90.   "
215792|NCT00675805|"     In patients treated with the monoclonal antibody infliximab (Remicade®) -which binds to and     blocks tumor necrosis factor alpha (TNF-alpha) - an infusomat filter is routinely used to     prevent the very same early adverse events observed in individuals receiving intravenous     immunoglobulins (IVIG). We recently used such a filter in a patient suffering from malaise     and vomiting in the context of an IVIG substitution therapy. In this patient symptoms     improved and IVIG-induced complement-activation was reduced (unpublished observation).      Based on this simple observation we hypothesize that this simple and approved filter-system     may be efficient in retaining complement-activating immunoglobulin G (IgG) aggregates in     IVIG-preparations. This effect may reduce complement activation - and consecutive     inflammation - thereby diminishing adverse events.      In this prospective study we propose to investigate how complement activation and side     effects after IVIG infusion relate in individuals receiving conventional (i.e. unfiltered)     vs. filtered IVIG-preparations.   "
215793|NCT00675818|"     Acute kidney injury (AKI) in the intensive care unit is common, devastating and costly.     However, minimal evidence exists to guide the prescription of optimal renal replacement     therapy (RRT). An important area of uncertainty surrounds the relative effects of convective     versus diffusive modes of clearance. Although both clearance modes provide similar degrees of     small molecule clearance, convective modes permit the enhanced clearance of larger-sized     molecules which may mediate kidney and systemic toxicity in the setting of AKI.      Continuous renal replacement therapies (CRRTs) are frequently applied in critically ill     patients with AKI. Convective clearance, as applied through continuous venovenous     hemofiltration (CVVH) and diffusive clearance, as applied through continuous venovenous     hemodialysis (CVVHD), may be readily compared in the context of patients receiving CRRT.      The purpose of this study is to examine the feasibility of conducting a larger study that     will determine whether convective clearance (hemofiltration) confers improved outcomes as     compared to diffusive clearance (hemodialysis) in patients with AKI.   "
215794|NCT00675831|"     The purpose of this research study is to evaluate the safety and efficacy of cell depletion     in a donor lymphocyte infusion (DLI) product with the use of the CliniMACS machine.     Previously, patients with hematologic malignancies who have relapsed after transplant have     been given infusions of donor white blood cells calsed donor lymphocyte infusion (DLI) as a     way to boost their immune function and fight cancer. Information from other research studies     suggests that lowering the number of a certain type of white blood cell called CD25+ Tregs in     the DLI may allow for a greater effect. In this research study, we are looking for the     appropriate dose of DLI depleted of the CD25+ Treg white blood cells that can be given     safely.   "
215795|NCT00675844|"     Extension study for subjects currently participating in protocols ACH443-015 and ACH443-018.   "
215796|NCT00675857|"     The main objectives of the current study are to establish the safety and clinical     proof-of-concept of NC-503 in inadequately controlled patients with Type 2 diabetes and     features of metabolic syndrome treated with either metformin, a sulfonylurea agent, or     metformin in combination with a sulfonylurea agent.   "
215799|NCT00675896|"     To compare the efficacy of Quetiapine SR versus placebo over 8 weeks in unipolar     non-psychotic adult outpatients depression and comorbid fibromyalgia. This will be measured     by the last observation carried forward (LOCF) mean change from baseline to week 8 on the     Hamilton Depression Scale (HAM-D) total score.      For the purposes of this study, response regarding improvement in depressive symptoms will be     defined as a 50% decrease in HAM-D scores over 8 weeks. Furthermore, proportion of patients     achieving remission is defined as an HAM-D total score of 7 at end of treatment. The anxiety     comorbid symptoms often associated with major depression will be assessed with the HAM-A (14     items) scale. Proportion of patients responding and achieving remission of anxiety symptoms     are defined respectively as a reduction of 50% in the HAM-A total score from baseline and a     HAM-A total score of 7 at the end of treatment.   "
215800|NCT00675909|"     Lacerations (deep cuts) are a frequent cause of visits to emergency departments and     laceration repair is one of the most common procedures performed in that setting. Children     are often anxious when they visit the emergency department, and visits where they anticipate     needing painful procedures can be particularly stressful. Though we can manage the pain     associated with many minor procedures, we are frequently unable to adequately support the     child and treat their problem if we don't manage their anxiety as well. Methods of calming     that do not require medication (e.g. distraction, parental support) can help, but many     patients still require sedative medications.      The goal of sedation in the pediatric emergency department is to relieve the child's anxiety     while minimizing the risk of adverse events. Unfortunately, when sedative medications are     used in doses that do not slow breathing, they often fail to manage the child's anxiety     adequately. In addition, many sedative agents require the placement of an intravenous line,     which is itself a painful procedure that can create, rather than relieve, anxiety.      Currently, there is no ideal sedative agent that is safe, effective, and easy to administer.     Oral midazolam is one of the most commonly used sedative medications for laceration repair in     children. In a dose of 0.5mg/kg it has been shown to be safe. Unfortunately, it provides     adequate sedation in only about two thirds of patients and has a delayed onset of up to 20     minutes. The remaining children must either endure the procedure in an agitated state or     suffer placement of an intravenous line to administer additional sedative medications.      We aim to find a method of providing sedation for laceration repair that has a higher success     rate than oral midazolam as currently prescribed without increasing the risk of     complications. We would like to evaluate new methods for administering midazolam using     alternate routes and dosages. Previous studies have looked at the use of midazolam absorbed     directly by mucous membranes such as inside the nose (intranasal) and inside the mouth     (buccal). The use of intranasal midazolam has had some success especially given its rapid     onset of action (about 5 minutes), but has been limited by the irritant effects of the drug.     When placed in the mouth, many children swallow the drug or spit it out rather than allowing     it to be absorbed by the mucous membrane. There has been some improved success when the drug     was placed under the tongue, but this is typically difficult for young children. However, a     new device called an atomizer has been developed that allows for improved intranasal and     buccal administration. The atomizer has a small adapter placed on the end of a syringe,     which spreads the medication out in a fine mist over a wide area. It can be sprayed in the     mouth inside the cheek (buccal), avoiding the need to keep the medication under the tongue.     While some pediatric institutions have already started giving midazolam with the atomizer,     and are reporting anecdotal success with these methods, its safety and effectiveness have not     been rigorously studied.      We propose to compare three approaches to sedation: commonly used doses of oral midazolam,     atomized intranasal midazolam and atomized intraoral midazolam. Children under the age of 7     requiring sedation for wound repair will be eligible for enrollment. After informed consent,     children will be randomized to one of the three methods described above. Their level of     sedation will be determined using two scores validated for use in children (the sedation     score and the modified CHEOPS score). Physician, nurse and parent impressions of sedation     will also be compared.      By comparing our current approach to these new methods, we will be able to determine which     method is best. If we can identify a method for administering the sedative drug midazolam     that is safe, well tolerated, and more effective, we will have made a valuable and important     contribution to the care of injured children in the emergency department.   "
215801|NCT00675922|"     Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound     healing, length of hospital stay).   "
215802|NCT00675935|"     The goal of our project is to prevent patient falls by translating an individual patient's     fall risk assessment into a decision support intervention that communicates fall risk status,     and creates a tailored evidence-based plan of care that will be accessible to members of the     care team to prevent falls.   "
215803|NCT00675948|"     The purpose of this study is to assess the safety and tolerability of long term therapy with     Sativex® and GW-2000-02.   "
215804|NCT00675961|"     The primary goal of this study is to assess the effectiveness of two alcohol interventions     administered singly or in combination as an integrated component of TB care provided to     patients with co-occurring TB and AUDs in Tomsk, Russia. Here we propose two parts of this     study:      First, a pilot study to provide Naltrexone to TB patients will be conducted. If feasibility     and safety are demonstrated, then we will conduct a randomized clinical trial (RCT) of the     following four study arms:        1. A Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard          referral to and management by an addictions specialist);        2. Naltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU        3. BCI + Naltrexone/BBCET plus TAU        4. TAU The RCT will be conducted only if Naltrexone use proves safe and feasible in the          pilot study. However, because the pilot does not have a control group and nor is it a          Phase I clinical trial, we define safety here as demonstration of appropriate adverse          event management and adequate safety monitoring procedures, all of which will also be          used in the RCT.      The specific aims of the pilot are:        1. To determine the feasibility of administering Naltrexone to patients receiving TB          treatment, and        2. To assess the safety of administering Naltrexone to patients receiving TB treatment.      The investigators aim to test the following hypotheses for the pilot: co-administration of     Naltrexone with TB treatment is feasible and safe in a population of TB patients with AUDs.      The specific aims of the RCT are:        1. To compare TB treatment outcomes among patients in each of the three intervention arms          with the control arm of treatment as usual, and        2. To compare the change in mean number of heavy drinking days in last month of study          period compared with baseline among patients in each of the three intervention arms with          the control arm of treatment as usual.      The investigators aim to test the following hypotheses for the RCT: Individuals receiving one     of the three interventions (Naltrexone, BCI or the combination of Naltrexone/BCI) will     experience better TB outcomes and a greater change in the mean number of heavy drinking days,     compared with individuals receiving treatment as usual.   "
215805|NCT00675974|"     1. Will Pressure Garment Therapy better control hypertrophic scarring than no Pressure          Garment Therapy.        2. How will Pressure Garment Therapy affect functional capacity or scar contracture          development across joints either in number or severity.        3. Will Pressure Garment Therapy diminish discomfort due to pruritus.   "
215806|NCT00675987|"     The main purposes of this study are to find out if the study drug losartan (Cozaar) or     placebo (sugar pill) has an effect on insulin sensitivity (how your body responds to     insulin) and to measure the effect of the study drug losartan or placebo on how the arteries     in your arm dilate (enlarge to carry more blood).      We hope to learn if taking losartan changes the amount of certain proteins in the blood that     effect blood vessel function.      Losartan is approved by the US FDA to treat high blood pressure. It will take approximately 4     months for you to complete this study.   "
215807|NCT00676000|"     Vaginal prolapse is a common condition that is treated with surgical correction. Recently     surgeons have been using mesh to augment the repair of vaginal prolapse. Common complications     of this surgery include vaginal pain, pain during sex, infection or erosion of the mesh in     the vagina. There are different ways to close the vaginal wall over the mesh used in these     procedures. Currently, there is no accepted standard method of closing the vaginal wall. The     purpose of this study is to find out the best way to close the surgical wound in the vagina.     We will compare interrupted closure (separate stitches) to continuous closure (one long,     running stitch). We hope to show in our study that one method of closure is better than the     other.   "
215808|NCT00676013|"     The purpose of this study is to determine if using a DERMAL LAYER under skin grafts:        1. will reduce scar formation of skin grafts        2. will reduce burn wound contractures        3. will improve functional outcome of joints requiring grafts        4. will reduce healing times and potential complications of donor sites      Compare scarring outcome of Dermal products   "
215809|NCT00676026|"     The goal of this series of challenge studies is to examine the impact of menstrual cycle     phase on cortical GABA response to administration of agents with either direct     (benzodiazepines) or indirect (progesterone, fluoxetine) GABA modulating properties. While     the impact of these agents on cortical GABA levels in women with premenstrual dysphoric     disorder (PMDD) is of interest, this study is designed primarily for those women without a     psychiatric illness.   "
215851|NCT00676598|"     Therapeutic hypothermia has been shown to improve survival and neurologic outcome in patients     resuscitated after ventricular fibrillation arrest.      Few studies have examined whether therapeutic hypothermia is effective outside the research     setting, or with other presenting rhythms.      Our institution, a large community teaching hospital, instituted a therapeutic hypothermia     protocol in November 2006 for all resuscitated cardiac arrest patients.      The investigators seek to determine the mortality rate of our protocol and compare our     complication rates with those of previously published studies.   "
215810|NCT00676039|"     Generic medications should be the equivalent of brand medications with the exception of their     price. Before a generic medication is introduced, its bioequivalence within a window of 80 to     125% of the original has to be demonstrated. There are reports that this criterion is not     always followed in post-marketed periods. Such investigations were triggered by the     observation that some patients previously stable on original medications relapsed when     switched to a presumable equivalent generic. Several factors could account for this problem.     Given reports of such problems occurring with the antidepressants citalopram and venlafaxine,     some pharmacokinetic properties of specific brands of generics and the originals will be     examined for these two medications. Twelve healthy male volunteers will participate in this     crossover study. It is anticipated that there will be significant differences emerging     between the two formulations given the clinical reports of patients deteriorating when     switched from the original to the generic preparations.   "
215814|NCT00676104|"     The primary goal of this project is to demonstrate the feasibility and clinical benefits of a     new rapid treatment for secondary treatment for secondary brain injury called Discrete     Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced     hypothermia in the adult brain without significant whole body hypothermia. Discrete Cerebral     Hypothermia System holds a great potential for protecting the brain from the devastating     secondary complications of trauma without the associated deleterious system effects.   "
215815|NCT00676117|"     The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H)     during repeated oral administration with and without co-administration of loxoprofen and the     pharmacokinetic profile of loxoprofen during repeated oral administration with and without     co-administration of Esomeprazole (D961H).   "
215816|NCT00676130|"     The primary aim of this study is to quantify the effectiveness of Bactrim as additional     therapy for the treatment of uncomplicated cellulitis in adults, by comparing: standard     therapy plus Bactrim, versus standard therapy plus placebo.      The primary hypothesis of this study is that, in light of increasing CA-MRSA prevalence,     subjects treated with standard therapy plus Bactrim will have higher cure rates than those     treated with standard therapy plus placebo.   "
215817|NCT00676143|"     This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in     patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab     or placebo. Each patient's participation will last approximately 1.5 years.   "
215818|NCT00676156|"     The purpose of this study is to learn about an investigational drug known as oral lipoic acid     (LA) that may help treat multiple sclerosis. This study will measure how a person's body     absorbs and breaks down the drug (pharmacokinetics) and will compare four different forms of     the drug from four different manufacturers as well as LA in conjunction with fish oil.   "
215819|NCT00676169|"     The purpose of this study is to better define risk factors preceding first isolation of     Pseudomonas aeruginosa (Pa) from respiratory cultures in cystic fibrosis (CF) lung disease     and to better define clinical outcomes associated with acquisition of Pa. This study will     also collect and bank DNA samples for current and future studies designed to enhance the     understanding of the pathogenesis of CF.   "
215820|NCT00676182|"     The scientific objective of this program is to meet the rehabilitation needs of combat     wounded Veterans with mild to moderate Traumatic Brain Injury (TBI) via telerehabilitation     and determine the effect of this modality of care on patients' physical health and outcomes     including function and community participation. The investigators will also evaluate the     benefits and limitations of rehabilitation using telehealth from the Veteran and caregiver     perspectives and evaluate the impact of rehabilitation via telehealth on Veterans     Administration (VA) healthcare facility use.   "
215821|NCT00676195|"     The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC)     in children with Autism.   "
215822|NCT00676208|"     While medical training has increasingly included chronic care management, quality care     necessitates education approaches that go farther. In April 2005, the Louis Stokes Cleveland     Veterans Affairs Medical Center (VAMC) implemented a weekly Diabetes Shared Medical     Appointment (SMA). SMAs offer an important opportunity to improve chronic care and a unique     setting for training physicians. In order to equip physicians with needed resources to manage     chronic care, the ways in which SMA experiences are processed and integrated into learning     about interdisciplinary approaches and expanding trainees' understanding of chronic care     issues need to be examined.   "
215823|NCT00676221|"     Hypothesis: Presently, some patients' mycophenolate mofetil (MMF.,Cellcept) related     gastrointestinal (GI) symptoms are not being spontaneously reported. It is postulated that a     conversion to enteric-coated mycophenolate sodium (EC-MPS.,Myfortic) from MMF will reduce the     objectively measured GI symptom burden and improve GI-related quality of life.      Primary Objective: To determine the incidence of GI-related symptoms and the health related     quality of life of renal transplant patients that are currently tolerating MMF. Assessed by     GSRS and GIQLI.      Secondary Objective: To determine the impact on GI symptoms and the health related quality of     life of renal transplant patients converted from MMF to Myfortic. Assessed by GSRS and GIQLI.   "
215824|NCT00676234|"     Pilot study aiming to assess the effect of two doses of rhu EPO on urine NGAL concentration     and on serum cystatin C and creatinine levels in critically ill patients at risk of ARF.   "
215852|NCT00676611|"     The purpose of this research is to study a specific acetabular (hip socket) fracture pattern     and how its treatment affects the functional, clinical, and x-ray outcomes. There are no     experimental procedures involved.   "
215938|NCT00670371|"     The objective is to find determinants for the subjective and objective burden of informal     caregivers to patients who are requiring continued antipsychotic treatment for functional     psychoses among factors related to the patient, the health care and support provision system     and the informal caregiver him/her-self.   "
215825|NCT00676247|"     Although several studies have contrasted the hemodynamics of cerebral arteries using cranial     Doppler ultrasound between full-term and preterm infants, the assessments were mostly     conducted in the first days of life. Furthermore, the clinically significant hemodynamic     parameter has been established from a small sample of infants that its validity on other     populations remains unclear. Therefore, the purpose of this study is twofold:        1. to examine the hemodynamics of cerebral arteries in full-term and very low birth weight          preterm infants at term age        2. to assess the validity of the hemodynamic parameters in relation to concurrent          neurobehavioral function.      This study will enroll normal full-term infants and very low birth weight preterm infants who     have no major neonatal disease. Cranial Doppler ultrasound examination will be performed on     all infants at term age. Hemodynamic parameters will include peak systolic velocity, end     diastolic velocity, resistance index and pulsatility index for the bilateral anterior     cerebral arteries and middle cerebral arteries. Neurobehavioral development will be     administered on the same day using the Neonatal Neurobehavioral Examination- Chinese version.   "
215826|NCT00676260|"     The purpose of this study is to measure microcirculation in type 2 diabetes patients with     peripheral edema who are taking pioglitazone, once daily (QD).   "
215912|NCT00677391|"     The primary objective of this study was to evaluate the efficacy and the safety of     sibutramine vs. placebo in combination with a hypocaloric diet on weight-loss in overweight     and obese Malaysian subjects.   "
215827|NCT00676273|"     The purpose of this study is to determine whether TVT-Secur (TVT-S) (Hammock method) and     TVT-Obturator (TVT-O) suburethral sling procedures have equivalent patient satisfaction and     clinical efficacy in the treatment of stress urinary incontinence alone or the stress     component in mixed urinary incontinence.   "
215828|NCT00676286|"     This study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers     and determine if these tests can detect cancers that become aggressive.   "
215829|NCT00676299|"     The purpose of this study is to assess JNJ-26483327 (a drug in development for cancer) for     the safety of the drug in patients with advanced solid tumors that have not responded or are     no longer responding to available therapies. The absorption, breakdown and elimination of the     drug will also be studied.   "
215830|NCT00676312|"     This study is designed to investigate the safety and tolerability of PTH134 in healthy     subjects and to assess the exposure from PTH134.   "
215831|NCT00676325|"     A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the     anterior vaginal wall prolapse.   "
215832|NCT00676338|"     This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy     to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione)     in drug naive patients with type 2 diabetes treated with diet and exercise.   "
215833|NCT00676351|"     A significant proportion of asthma is diagnosed during childhood. Bronchiolitis is the most     common lower respiratory tract illness (LRI) in early life and the present work is a     prospective study undertaken to highlight the possible relationship between LRI in early life     and trigger of atopy and asthma in 3 year-old childhood, using paediatric lung function     testing.      Twenty nine infants (8 females and 21 males) were included in our study. The beginning of the     study started at least three weeks after the first bronchiolitis episode. Pulmonary function     test was realized using an infant specific body plethysmography (Babybody, Erich Jaeger,     Germany). Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary     function was evaluated by measuring respiratory resistances using oscillometry and occlusion     systems (Masterlab-IOS, Erich Jaeger, Germany). If measured data showed an obstruction, a     bronchodilatator was inhaled to assess reversibility. When results were normal, a bronchial     provocation test, using inhaled metacholine, was performed.      Skin prick tests (SPTs) were performed during the first exam, and at 24 and 36 months     (Stallergenes-DHS).      Collection of data was largely incomplete due to a number of patients lost of follow up.     Based on the available data, it can be conclude that most of lung tests results were in the     normal range but a non negligible bronchial hyper reactivity was documented (41% of     patients).      This study must be continued to increase the number of included patients and to continue     their follow up during a longer time.   "
215834|NCT00676364|"     The purpose of this study is to evaluate the amount of anxiety and pain felt by children     during procedures that require a needle stick after using a topical anesthetic or placebo     cream.   "
215835|NCT00676377|"     Postoperative ileus (POI) in the absence of any mechanical obstruction remains a commonly     encountered clinical problem.So, this study aimed to show the effective way to decrease the     rate of postoperative Ileus (POI).   "
215836|NCT00676390|"     The treatment and follow-up of congestive heart failure (CHF) represents a major part of     France's health expenses. The beneficial effects of cardiac rehabilitation is well     established, especially regarding the reduction of dyspnea, exercise limitation and fatigue     and leads ultimately to a better quality of life. Maintaining these benefits in secondary     prevention requires an improvement in daily physical activity, which is challenging and     supposes a close follow-up difficult to perform on a daily living basis. However, a better     knowledge of the type and dose of daily physical activity of this population would be very     beneficial for the practitioner to prescribe or advise individually the type and the dose of     physical activity required to maintain the benefits of cardiac rehabilitation. To date, only     a physical activity questionnaire adapted to CHF could provide information regarding both the     type and dose of daily physical activity. Such a questionnaire has been developed by our     research team and allows an estimation of daily energy expenditure as well as the daily     energy expended in its physical activity dimensions (rest, activities < 3 MET, activities     between 3 and 5 MET, and activities > 5 MET). During its first step of validation, daily and     physical activity energy expenditure estimated by this questionnaire was correlated to     various factors of physical condition and notably, to peak V'O2 (R=0.71), prognostic factor     largely recognized in CHF. A second step of validation was a pilot study comparing the     estimation of daily energy expenditure by the questionnaire with a measurement of free-living     daily energy expenditure with the doubly labelled water (DLW) method in 11 middle-aged males     patients suffering CHF (NYHA I to III). Daily energy expenditure estimated from the     questionnaire was very close to daily energy expenditure measured from the DLW method (R2 =     0.81; individual relative error < 7%). However, the high cost of the DLW method reduced the     population studied to a small sample, which is a major limitation of this study since the     sample was somewhat different to general CHF population in France.   "
215837|NCT00676403|"     To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients   "
215871|NCT00676858|"     The purpose of this study is to use transesophageal echocardiography (TEE) to determine the     incidence, severity, and clinical significance of gas bubbles during argon plasma coagulation     (APC).   "
215892|NCT00677131|"     The primary purpose of this study is to evaluate the patient education efficacy of the     pharmacists in National Taiwan University Hospital. We randomize patient family into one of     the following three groups:        1. To read the package insert of the drug        2. To read the education information provided by Pharmacy of NTUH        3. Oral education provided by the pharmacist      Then we will evaluate the difference on patient knowledge of reconstitution, storage, and     administration of oral antibiotic suspension from powder dosage form between these three     groups.   "
215838|NCT00676416|"     The change of airway responsiveness and alveolar macrophage (AM) immunity occurs during the     pathogenesis of asthma. Macrophage-associated airway protection in patients with asthma is     affected positively or negatively by propofol general anesthesia. The investigators     hypothesized that the effects of propofol on asthmatic AMs and corresponding airway     reactivity in vivo is different from the in vitro research. Through in vivo airway     hyperresponsiveness (AHR) observation and clinical investigation of AM immune functions from     asthma patients undergoing propofol general anesthesia to clarify the precise effects of     propofol on AM immunity, and to provide theoretical basis for the clinical administration of     propofol in asthmatic patients. This would optimize the practice of clinical anesthesia,     especially for those with the tendency of AHR.   "
215913|NCT00677404|"     The purpose of this study is to investigate the efficacy and safety of autologous     transplantation of mononuclear cells with and without G-CSF in patients with chronic lower     limb ischemia.   "
215927|NCT00677586|"     The purpose of this study is to investigate the safety of simultaneous liver resections     compared to staged hepatectomies of colorectal cancer with liver metastasis and to compare     the long-term survival between the two groups.   "
215839|NCT00676429|"     To investigate and compare the efficacy, safety and tolerability of ziprasidone versus     placebo in the treatment of conduct disorder (CD), oppositional defiant disorder (ODD) and     disruptive behavior disorder not otherwise specified (DBD-NOS) of older children and     adolescents in an outpatient setting.      Conduct and other behavior disorders are some of the most common forms of psychopathology in     children and adolescents. The main characteristic of these disorders is a repetitive and     persistent pattern of antisocial, aggressive or defiant behavior that involves major     violations of age-appropriate expectations or norms. According to the guidelines of the     German Society for Child & Adolescent Psychiatry & Psychotherapy (Deutsche Gesellschaft für     Kinder- und Jugendpsychiatrie und -psychotherapie DGKJPP), the European Society for Child and     Adolescent Psychiatry (ESCAP), and the American Academy of Child and Adolescent Psychiatry     (AACAP) currently no standard pharmacotherapy is established and recommended for children and     adolescents. However Risperidone has been shown to be effective in the treatment of patients     with disruptive behavior disorders and below average IQ.   "
215840|NCT00676442|"     We will evaluate the effect of food on the bioavailability of the components of PN400   "
215841|NCT00676455|"     The purpose of this study is to evaluate the ability of a new type of CT computer     program(MeVis™)to accurately analyze and measure the size and changes in metastatic Liver and     Lung tumors. This study will evaluate the data from current CT evaluation methods using the     MeVis™ 3-D software.   "
215842|NCT00676468|"     Combining fish oil supplementation and Montelukast [a commonly used cyst LT1 receptor     antagonist to treat exercise-induced bronchoconstriction (EIB)] will provide a greater     antiinflammatory effect against developing EIB that either agent alone   "
215843|NCT00676481|"     The purpose of this study is to test data collection options in emergency departments (EDs)     and to enhance ED patient awareness of the risk of HIV infection.   "
215844|NCT00676494|"     The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active     removal of atherosclerotic debris and thrombus in peripheral vasculature.      This is a prospective, single arm, multi-center study to obtain safety and performance data     for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for     percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the     lower limb peripheral vasculature.   "
215845|NCT00676507|"     Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune     response to kill tumor cells. It is not yet known whether vaccine therapy is more effective     than a placebo as maintenance therapy in treatment of subjects with non-small cell lung     cancer.      Purpose: This randomized phase III trial is studying vaccine therapy to see how well it works     compared with a placebo in treating subjects with stage III or stage IV non-small cell lung     cancer.   "
215846|NCT00676520|"     XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives     of this study are        -  To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in          real world settings, and        -  To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT)          initiative. This initiative is designed to evaluate the composite of all death,          myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free          from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and          that have been treated with drug eluting stents (DES) and extended dual antiplatelet          therapy.   "
215847|NCT00676533|"     The primary objective of this clinical trial was to determine the time to improvement of the     signs and symptoms (eg, dysuria, frequency, urgency, gross hematuria, suprapubic pain,     hesitancy, low back pain) of acute, uncomplicated, symptomatic, lower UTIs in women treated     with Cipro XR 500 mg once daily for 3 days.   "
215848|NCT00676559|"     This study looks to continue the study of anti-vegf therapy in patients with macular edema,     and compare it to an anti-inflammatory therapy and a combined Anti-vegf and     anti-inflammatory.   "
215849|NCT00676572|"     This research aims to find out how the inflammation in patients suffering from severe asthma     is different from that in non−severe asthma, and how it may prevent corticosteroids from     working efficiently in severe asthma.      It will look,in particular, at a protein enzyme called p38 mitogen−activated protein kinase     (p38 MAPK for short)which controls the activation of several important pathways in the cell.     We wish to find out whether this enzyme is more active in cells obtained from patients with     severe asthma compared to those with non−severe asthma. We would like to understand how this     enzyme can cause the cell to respond less well to the anti−inflammatory effects of     corticosteroids. We also wish to find out whether any specific inhibitors of p38 MAPK can     improve severe asthma by improving the effects of corticosteroids on these cells.      We hypothesise that activation of the intracellular MAPK signalling pathway underlies the     inflammatory processes of severe asthma, and leads to the diminution of the anti-inflammatory     actions of CS through histone modification.   "
215850|NCT00676585|"     The major goal of this project is to determine whether the use of physiologic doses of     corticosteroids will decrease time to shock reversal, alters the inflammatory cascade, and     alters microcirculatory flow in post-cardiac arrest patients.   "
215891|NCT00677118|"     The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant     chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC,     in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC)     patients.   "
215893|NCT00677144|"     The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (OS) and     Oxaliplatin and Capecitabine (XELOX) in patients with advance or recurrent colorectal cancer.   "
215910|NCT00677365|"     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which     has been particularly problematic to eradicate and been implicated as the major cause of     morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung     increases the local concentrations of antibiotic at the site of infection resulting in     improved antimicrobial effects compared to systemic administration. Bacterial resistance to     current aerosol antibiotic treatments indicate a need for improved therapies to treat CF     patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and     other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to     have antimicrobial effects on even the most resistant organisms.   "
215853|NCT00676624|"     Uveitis is an inflammatory disease of one or both eyes. Uveitis will in severe cases lead to     permanent loss of vision/blindness on the affected eye. Uveitis can be caused by autoimmune     disease, infections and rarely trauma, but 50 % of the cases remain of unknown origin.     Intraocular infections are from previous studies, known to be responsible for approximately     40 % of the cases of severe forms of uveitis. Most infectious causes of uveitis have the     potential to be treated with antibiotic.      Most infectious causes of uveitis are under normal condition only possible to detect by using     very specific detection methods. Further more it is often necessary to study a sample from     with-in the eye (vitrectomy to get a proper diagnosis. The knowledge about witch kind of     infections that causes uveitis, are therefore limited to the kind of infections that are     tested for.      Our hypothesis are that infections are a frequent cause of severe uveitis in Denmark, and     that by using a broad diagnostic approach it is possible to identify new or less recognized     infections agents that are associated with uveitis. By this study we want to describe the     prevalence and distribution of infections among patients with severe uveitis. In this study     are we only including patients with a severe form of uveitis from a referral-hospital     setting, where vitrectomy is done for a diagnostic purpose.      The patients will undergo a standard diagnostic examination including the most common     infectious causes of uveitis. Beside this we will look for a broad range of infection, which     has previously been described in the litera-ture to cause uveitis, but are not normally     tested for. Further more, we will use broad ranged molecular diagnostic methods to look for     new previously unknown bacterial causes of uveitis. Such study has not previously been done     previously in Denmark. As control group are included patients that undergo vitrectomy for due     either one of the two diseases epiretinal fibrosis or macula hole. All patients and     controls will be interview using a standardized questionnaire about risk factors for     acquiring these infections.   "
215854|NCT00676637|"     The purpose of this study is evaluate adherence to DuoTrav® when reinforced by the use of the     Travalert™ Dosing Aid.   "
215855|NCT00676650|"     This study will compare the safety and efficacy of sunitinib in combination with prednisone     versus placebo and prednisone in patients that have metastatic castration-resistant prostate     cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen.     This is a second-line study.   "
215856|NCT00676663|"     The purpose of this study is to evaluate the safety and efficacy of entinostat in combination     with exemestane in the treatment of advanced breast cancer.   "
215857|NCT00676676|"     The purpose of the study is to determine whether adding a low dose of testosterone to current     antidepressant therapy improves depression and fatigue in women who remain depressed despite     necessary adequate doses of anti-depressants. Testosterone will be given over an 8-week     period.      Testosterone is a hormone that occurs naturally in the body. In women it comes from the     ovaries and adrenal glands and is found in amounts that are ten to twenty times lower than in     men.      In early research studies, testosterone has been shown to have some antidepressant effects in     the following groups of subjects:        -  Women with anorexia nervosa        -  Women who have low testosterone levels because their pituitary glands do not work        -  Men with Selective Serotonin Reuptake Inhibitor (SSRI)-resistant depression.      However, testosterone administration in women with SSRI or Serotonin-norepinephrine reuptake     inhibitor (SNRI) -resistant depression has not been studied.   "
215858|NCT00676689|"     To assess the safety and effectiveness of pulmonic THV implantation in subjects with     dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation     (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by     TTE.   "
215859|NCT00676702|"     The purpose of the study is to evaluate the enzyme activity and safety of pancrelipase in     patients with severe Exocrine Pancreatic Insufficiency (EPI)   "
215860|NCT00676715|"     This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and     Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as     measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants     with Relapsing Remitting Multiple Sclerosis (RRMS).   "
215861|NCT00676728|"     The purpose of this study is to explore the safety, pharmacokinetic (what the body does to     the medication), pharmacodynamic (what the medication does to the body), and activity of     JNJ-26481585 in patients with advanced or refractory leukemia and myelodysplastic syndrome     (MDS).   "
215862|NCT00676741|"     The study is conducted in Europe. The aim of this observational study is to evaluate the     blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir®     for the treatment type 2 diabetes.      Full acronym for this study: COMMIT - CLEAN SWITCH   "
215863|NCT00676754|"     The purpose of this study is to better understand tuberculosis (TB) and the risk of infection     with TB, in Peru. TB is a disease that is caused by bacteria and transmitted through droplets     in the air that come from the lungs of an infected person. The risk of infection will be     compared between two groups: household members, who live with people having TB that does not     respond well to treatment and household members, who live with people having TB that responds     well to treatment. Study participants will include 4,500 TB infected people and 22,500 of     their household contacts. Study procedures include answering a questionnaire, TB skin tests,     blood samples, and a chest x-ray. Individuals with symptoms indicating TB will be asked to     provide sputum samples. Individuals with TB will be involved in the study for up to 48     months; household contacts will be involved in the study for 12 months. The knowledge gained     from this study will be used to improve tuberculosis control.   "
215864|NCT00676767|"     The purpose of this study was to determine how blood glucose changes after eating energy bars     containing resistant starch type 4 compared with bars made with puffed wheat in healthy older     adults.   "
215865|NCT00676780|"     The purpose of the study is to see if a green tea extract can beneficially alter several     markers of cancer risk and progression.   "
215866|NCT00676793|"     To see if an extract of green tea can affect certain markers of breast cancer and breast     cancer progression in women with a recent biopsy positive for cancer and who are scheduled     for surgery.   "
215867|NCT00676806|"     This study is designed to determine whether Umbilical Cord Transplantation (UCB) can be     substituted for adult bone marrow cells in the standard stem cell transplant regimens used at     this hospital for subjects who do not have stem cell donors.   "
215868|NCT00676819|"     This trial is conducted in Europe. The aim of this trial is to investigate if the     pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are     different in elderly (65 years of age or older) with type 2 diabetes.   "
215869|NCT00676832|"     The purpose of this study is to determine whether COLAL-PRED is a safe and effective     treatment for patients with moderate to severe ulcerative colitis.   "
215870|NCT00676845|"     This study will analyse the dose-dependent effect of olmesartan medoxomil on the change in     arterial stiffness in subjects with hypertension and metabolic syndrome   "
215872|NCT00676871|"     Phase 1:        -  Evaluate the safety and tolerability of MEDI-538 given by escalated doses with          continuous IV infusion for 4 weeks in adult patients with CLL.        -  Determine the maximum tolerated dose (MTD) of MEDI-538 administered by continuous IV          infusion for 4 weeks in this patient population        -  Describe the pharmacokinetics (PK) of MEDI-538        -  Describe the immunogenicity (IM) of MEDI-538        -  Determine the overall response, which is defined as follows: (1) conversion from PD/SD          to PR/nPR/CR or conversion from PR to nPR/CR using standard NCI-WG criteria; or (2)          conversion from MRD positivity to MRD negativity using 4-color flow cytometry; and        -  Describe any antitumor activity (ie, time to response and duration of response) of          MEDI-538 in this patient population.      Phase 2:        -  To determine the overall response in adult patients with CLL who have residual disease          following previous therapy for CLL.        -  Describe the safety,PK,and IM of MEDI-538        -  Determine the time to MRD relapse        -  Determine the antitumor activity (ie, time to response, duration of response,and time to          progression [TTP])of MEDI-538 in this patient population.   "
215873|NCT00676884|"     The primary objective of this study is to investigate the effect of AERODERM (also known as     pitrakinra, AER 001, BAY 16-9996) on Eczema Area and Severity Index (EASI) score in subjects     with moderate to severe atopic eczema   "
215874|NCT00676897|"     Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo   "
215875|NCT00676910|"     The purpose of this study is to assess the safety of JNJ-26854165 (a new drug in development     for cancer) in patients with advanced or refractory solid tumors on the maximum dose     tolerated by these patients.   "
215876|NCT00676923|"     The goal of this project is to examine the physical mechanisms that contribute to     improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of     bariatric surgery.   "
215877|NCT00676936|"     Study hypothesis: corticosteroids are effective for pain in cancer patients. We will perform     a double-blind, randomized, placebo-controlled multicentre trial evaluating the effect of     Methylprednisolone 16 mg twice daily in cancer patients with pain (average pain last 24 hrs     NRS > 4 (Numerical rating scale, 0 No pain, 10 worst pain).   "
215878|NCT00676949|"     The purpose of this study is to evaluate the clinical safety and efficacies of     cyclophosphamide combined cancer specific epitope peptides cocktail for advanced/relapsed     solid tumors including GI/lung/cervical cancers   "
215879|NCT00676962|"     The investigators propose to test the effect of external facilitation on the extent that     brief cognitive behavioral therapy (CBT) for depression is incorporated into routine practice     in primary care and community based clinics in the VA. The investigators will provide     training in brief CBT to mental health providers in participating clinics. To the     investigators' knowledge, this will be the first study of the effect of external facilitation     on outcomes of a training intervention.   "
215880|NCT00676975|"     To test the efficacy of Traditional Chinese Medicine in relieving symptoms and change of     quality of life of patients with Irritable Bowel Syndrome.   "
215881|NCT00676988|"     To assess the relationship between the change in Crohn's Disease Activity Index (CDAI) scores     and trough serum infliximab concentration in subjects who are scheduled to receive infliximab     infusions at an interval of 8 weeks.   "
215882|NCT00677001|"     The purpose of this study is to assess the safety of R306465 (a drug in development for     cancer) in patients with advanced cancer on the maximum dose that can be tolerated. Also, the     absorption, breakdown and elimination of the drug will be studied.   "
215883|NCT00677014|"     The primary objective of SMART-AV is to assess the effect of SmartDelay for determining     optimal AV delay timing during CRT compared to both a fixed AV delay and     echocardiography-determined optimal AV timing chronically over a 6-month period.   "
215884|NCT00677027|"     The purpose of this study is to evaluate the safety of increasing doses of MM-10-001 and to     determine the dose of MM-10-001 that enhances the immune system in normal healthy subjects.   "
215885|NCT00677040|"     This study involves women who have had a diagnosis of breast cancer, and have had a     lumpectomy with radiation treatments completed in the past year.      The study will determine the level of oxygen in the skin of the breast that has been     radiated, compared with the normal skin of the opposite breast.      The purpose of this study is to determine if there is a decrease in oxygen levels in the skin     which has been radiated, hopefully to find a treatment to limit skin damage caused by     radiation treatments, for women with breast cancer in the future.   "
215886|NCT00677053|"     The purpose of this study is to determine the safety and tolerability of multiple doses of     TAK-442once daily, (QD) or twice daily (BID), in subjects with acute coronary syndrome     (unstable angina, myocardial infarction).   "
215887|NCT00677066|"     Home oxygen therapy is considered an appropriate and relatively safe option for children with     chronic respiratory problems such as chronic lung disease of prematurity, but the use of home     oxygen therapy for children with acute respiratory problems is limited. With the recent     establishment of a Hospital in The Home (HiTH) program at our institution, we sought to     determine the safety, parental satisfaction and economic advantage of home oxygen therapy for     children with acute bronchiolitis compared with traditional inpatient hospitalization.   "
215888|NCT00677079|"     The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in     patients with breast cancer gene-associated (BRCA) ovarian cancer.      Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were     to be treated in a first stage, then if 2/12 patients responded to treatment as defined by     Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated     in the second stage.   "
215889|NCT00677092|"     The purpose of this study is to determine the efficacy of imatinib mesylate in reducing     cutaneous thickening and tethering in patients with nephrogenic systemic fibrosis (NSF). The     study will also work to assess the safety and tolerability of imatinib mesylate in patients     with chronic kidney disease and NSF.   "
215890|NCT00677105|"     The purpose of this study is to assess the safety of the drug (JNJ-24681585 a drug in     development for cancer) in patients with advanced or refractory solid malignancies or     lymphoma on the maximum dose that can be tolerated by these patients. The absorption,     breakdown and elimination of the drug will be studied and in some patients, the effect of the     food on these processes will also be examined.   "
215894|NCT00677157|"     This study will examine people who have pain or fatigue symptoms with a known or unknown     diagnosis to determine eligibility for other research studies. No treatment is offered under     this protocol.      People 18 years of age or older with symptoms of pain and fatigue may be eligible for this     study. Participants undergo standard examinations needed to diagnose or evaluate their     symptoms. The results of the test are used to screen subjects for possible participation in     other Nursing Institute studies. The study requires from one to three visits at NIH over 12     months for procedures that may include the following:        -  Medical history, physical examination and questionnaires related to symptoms and quality          of life.        -  Blood tests        -  Electrocardiogram        -  Tender point testing. Pressure is applied to areas of the shoulder, hip, neck, chest,          elbow and knee to identify tenderness.   "
215895|NCT00677170|"     This study is an open-label, multicenter, Phase 1, dose escalation study of MLN4924 in adult     patients with nonhematologic malignancies. This study will be the first to administer MLN4924     in humans. The patient population will consist of adults with any form of nonhematologic     malignancy for which standard, curative, life prolonging, or palliative treatment does not     exist or is no longer effective.   "
215896|NCT00677183|"     The purpose of this study is to document how often specific genotypes known to be associated     with adult-onset NASH (Non-Alcoholic Steatohepatitis) occur in a pediatric cohort and     investigate whether these genotypes are associated with increased susceptibility to NASH.   "
215897|NCT00677196|"     The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of     pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).   "
215898|NCT00677209|"     House dust mite allergy is a common problem, resulting in asthma, chronic swelling of the     eyes, and running nose. The investigators test a possibility to immunize subjects sensitized     against house dust mite with extracts from their own gut bacteria auto-vaccination.   "
215899|NCT00677222|"     The purpose of this study is to determine if escalating doses of AMI MultiStem® delivered by     catheter can safely be given to patients that have had a recent heart attack treated with     stent implantation.   "
215900|NCT00677235|"     The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR     Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or     other synthetic arteriovenous (AV) access grafts.   "
215901|NCT00677248|"     Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in     the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has     in clinical trials demonstrated pronounced reduction of several independent risk factors for     the development of atherosclerotic cardiovascular diseases.      The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to     ezetimibe following 10 weeks of exposure compared to placebo. The aim of the study is to     assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 and to define a     clinically relevant dose or dose range for future studies.   "
215902|NCT00677261|"     Many methods of pain relief have been implemented in an attempt to provide safe and effective     analgesia for patients following total knee arthroplasty. Numerous studies have demonstrated     that nerve blocks can provide superior pain control and reduce side effects. There are two     major nerves that provide sensation to the knee: the femoral nerve provides sensation to the     front of the knee and sciatic nerve provides sensation to the back of the knee. Putting local     anesthetic close to these nerves provides superior pain control. The literature has supported     the use of femoral nerve block for analgesia as well as improved functional outcome after     total knee arthroplasty. The purpose of this study is to see if the same is true for sciatic     nerve block for the back of the knee. We also would like to study an alternative approach to     make the back of the knee pain free. This involves injecting local anesthetic directly into     this area at the end of your surgery.Patients will be randomized into 3 groups: sciatic     block, posterior infiltration of local anesthetic and placebo.This study will help further     define the role of sciatic nerve block as well as the alternative technique of local     anesthetic infiltration in the perioperative analgesic regimen of total knee arthroplasty     surgery, in an effort to develop a standardized perioperative protocol for this patient     population. The advent of this protocol should allow reduced risk, improved analgesia, and     potentially earlier discharged from hospital with better function.   "
215903|NCT00677274|"     Epidural analgesia in the early stage of labor at cervix < 4.0cm was considered as a risk     period for increasing the rate of cesarean delivery. The more recent studies and the     investigators' previous data indicated epidural analgesia can be performed as early as the     cervical dilation approximately 2.0cm. The investigators hypothesized that different cervix     diameter had different rate of cesarean delivery. This trial would investigate the     correlation amongst different cervical dilation and the risk of cesarean section in     nulliparous women at term.   "
215904|NCT00677287|"     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402     restricted epitope peptides RNF43, TOMM34, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51     in combination with Tegafur/Uracil/Folinate chemotherapy.   "
215905|NCT00677300|"     The purpose of this study is to determine whether a combination of raltegravir and darunavir     is as effective as standard regimens in the treatment of HIV-infected patients who have not     previously used antiretroviral drug (treatment naive)   "
215906|NCT00677313|"     This is an open-label study to provide metreleptin for the treatment of diabetes mellitus     and/or hypertriglyceridemia associated with lipodystrophy. This study intends to provide     guidance to investigators with respect to identification of appropriate subjects for     metreleptin treatment, guidance on metreleptin dosing, and collection of safety and efficacy     data following metreleptin treatment in this population   "
215907|NCT00677326|"     The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201     restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in advanced     breast cancer patients.   "
215908|NCT00677339|"     The purpose of this study is to determine whether adjunctive L-arginine and vitamin D can     improve response to standard short course TB therapy in people with newly diagnosed pulmonary     TB.   "
215909|NCT00677352|"     To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with     panic disorder.   "
215914|NCT00677417|"     The values of laboratory examinations which are useful for the diagnoses of appendicitis are     white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation     rate (ESR). However up to date there is no laboratory marker for the pre-operative diagnosis     of appendiceal perforation in acute appendicitis. Recently hyperbilirubinaemia has been     associated with appendiceal perforation. Aim of this retrospective study is therefore to     investigate if hyperbilirubinaemia has a diagnostic value for the pre-operative diagnosis of     appendiceal perforation in patients with appendicitis.   "
215915|NCT00677430|"     The first objective of this study is to assess the accuracy of digital image-processing     techniques to provide measurements of human breast physical dimensions. The ultimate     usefulness of these techniques is to develop quantitative outcome measures of the visual     appearance of breast after local treatments for breast cancer. These measures will be used to     improve clinical outcomes from multimodality therapy that includes surgery and radiotherapy     and form the basis for the future development of patient decision making aids. The second     objective is to evaluate the relationship between patient reported body image outcomes and     measurement of human breast physical dimensions for patients with breast cancer.   "
215916|NCT00677443|"     Primary objective :      To compare the combination of S-1 and oxaliplatin(SOX) to the combination of capecitabine and     oxaliplatin(COX) therapy for advanced or metastatic colorectal carcinoma.      Secondary objectives :        1. To evaluate and compare the efficacy (overall survival and response rate) in the two          treatment groups.        2. To evaluate and compare the quality of life of the patients and safety profiles of the          two treatment groups.   "
215917|NCT00677456|"     There are four capital reconstructions after total gastrectomy which is widely used in China.     Life quality is the only standard to evaluate postoperative results of different     reconstructions. In order to determine the best reconstruction after total gastrectomy, we     designed this study to compare life qualities of four reconstructions.   "
215918|NCT00677469|"     The enterohepatic circulation of thyroid hormones is increased in thyrotoxicosis.Bile-salt     sequestrants (ionic exchange resins) bind thyroid hormones in the intestine and thereby     increase their fecal excretion. Based on these observations, the use of cholestyramine has     been tried. The present study evaluates the effect of low doses of cholestyramine as an     adjunctive therapy in the management of hyperthyroidism   "
215919|NCT00677482|"     Cytomegalovirus (CMV) is the most common viral infection in patients who have undergone a     transplant.Serious infections due to CMV can affect many parts of the body including the     lungs, the gut, and the liver. The purpose of this study is to assess how the virus interacts     with the patient's immune system, so that in the future it may be possible to develop better     ways to prevent and treat the virus infection.   "
215920|NCT00677495|"     Undetected or untreated CD may cause severe complications later in life, such as autoimmune     disorders.      It is recommended for subjects with autoimmune diseases or at risk for CD to be screened for     CD and to repeat serological screening about every three years to detect cases of clinically     silent, late-onset CD.      Celiac disease (CD) auto-antibodies against tissue transglutaminase (anti-tTG) are produced     in the intestinal mucosa even when not measurable in serum. By using the phage display     libraries technique it is possible to investigate in vivo (intestinal biopsy) early antibody     responses in autoimmune disease. In particularly, this technique demonstrated that the     humoral response against tissue transglutaminase occurs at the intestinal mucosal level, and     that the human VH5 gene is the commonly used variable region by the celiac patients to build     the anti-tTG. The intestinal mucosa production of IgA anti-tTG could be important in the     diagnostic work-up of early-stage CD, when mucosal histology is not yet diagnostic.      The investigators propose to 1) first degree relatives of CD patients, 2) subjects with     autoimmune disease, 3) symptomatic subjects (genetically predisposed to gluten intolerance)     tested negative for CD related autoantibodies and with apparently normal intestinal mucosa a     prospective study to uncover early-stage of gluten intolerance by measuring the mucosal VH5     restricted gene family anti-tTG clones in two biopsies: before and after one year of gluten     free-diet (GFD).      Aims of this clinical trial are:        1. to measure by means of phage display libraries the gluten dependent humoral immune          response (anti-tTG) of the intestinal mucosa in subjects with high risk of untreated CD,          without CD-related intestinal lesions.        2. to demonstrate the mucosal gluten-dependent immune response before and after 12 months          of gluten-free diet        3. to demonstrate that dietary intervention might modify the clinical condition (e.g          improvements of the gastrointestinal complaints or extra-gastrointestinal symptoms) of          the enrolled patients and the improvement of the intestinal inflammation with the          disappearance of the mucosal anti-tTG.        4. to evaluate the specificity of the double staining technique for detecting IgA          antitransglutaminase mucosal deposit with the phage display antibodies assay   "
215921|NCT00677508|"     We propose to develop parent and child disease-specific instruments to assess health related     quality of life (HRQoL) in children with constipation and fecal incontinence.   "
215922|NCT00677521|"     The objective of this study is to demonstrate a reduction of intrahepatic fat as measured     with Proton Magnetic Resonance Spectroscopy after 12 weeks administration of oral acarbose.     The study will also examine the hypothesis of whether the chronic administration of acarbose     in patients with NAFLD will influence postprandial substrate metabolism reflected in the RQ     measured by indirect calorimetry.   "
215923|NCT00677534|"     The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a     potential contributor to the morbidity witnessed in patients with end-stage renal disease   "
215939|NCT00670384|"     The purpose of this study is to identify an effective dose of allergen-specific immunotherapy     for short ragweed (Ambrosia artemisiifolia) administered by an oral/sublingual route.   "
215924|NCT00677547|"     Influenza virus is an important cause of morbidity in the transplant population and can lead     to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for     organ transplant patients, studies have shown that the standard inactivated influenza vaccine     has poor immunogenicity in this population. One major hurdle in the evaluation of the     response of influenza vaccine in immunocompromised patients is the lack of correlation     between humoral response and efficacy of the vaccine. In patients with poor immune responses,     cellular immunity may have a better correlation than humoral immunity with vaccine     protection. We plan to assess the utility of 3 assays that evaluate the cell-mediated immune     response (granzyme B, interleukin-10 (IL-10), and interferon-gamma (IFN-)) after influenza     vaccine in kidney transplant recipients. Results from this study have the potential to     directly improve patient care. The new monitoring assays may more accurately determine the     risk for development of influenza infection, and therefore allowing a better prevention     strategy.   "
215925|NCT00677560|"     Spirometry is a useful clinical tool for the assessment and monitoring of lung disease,     however, it does not provide information on peripheral airways resistance. On the contrary,     impulse oscillometry (IOS) may provide information not only on airway resistance (Rrs) but     also on the elastic properties of the lung (Xrs).      Even though patients with asthma may show some reduction of the caliber of the small airways     these changes are more a feature of patients with COPD. We hypothesize that IOS measurements     may detect these differences and provide different resistance profiles for asthma and COPD.   "
215928|NCT00677599|"     The purpose of this placebo controlled trial is to determine whether a year long intervention     with flavonoids (found in cocoa and soy) is more effective in reducing the risk of     cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy     (statins). A range of markers of cardiovascular disease risk are being studied and volunteers     are also providing urine and blood samples. 152 postmenopausal women, from the locality, will     be recruited for this study.   "
215929|NCT00677612|"     The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201     restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination     with Tegafur/Uracil/Folinate chemotherapy.   "
215930|NCT00677625|"     The purpose of this study is to collect data to examine and characterize the clinical     outcomes of pediatric patients diagnosed with any liver disease at Children's Hospital of     Wisconsin.   "
215931|NCT00677638|"     A prospective single arm study evaluating feasibility and safety of a catheter-based     transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with     severe aortic valve disease, specifically aortic stenosis, who are at elevated risk for     standard surgical valve replacement.   "
215932|NCT00677651|"     This project was created to assess sex differences in adipose tissue gene expression in     different locations in the body. The primary objectives are to understand:        1. The mechanisms of differential body fat distribution in men and women        2. How body fat distribution is affected by reproductive hormones        3. The mechanisms linking fat distribution to health risks such as diabetes   "
215933|NCT00677664|"     The purpose of this study is to evaluate the effects of Copaxone injections in retinal     function and integrity in diabetic patients who underwent pan-retinal photocoagulation.   "
215934|NCT00677677|"     Human papillomavirus (HPV) affects a significant number of transplant patients. In women,     human papillomavirus (HPV) causes genital warts, pre-cancerous areas of the cervix, and     cervical cancer. In men, the virus can cause warts of the anal and genital areas. Men can     also sexually transmit the virus to their partners. A patient who has had an organ transplant     is at higher risk of infections as well as cancers because of the lifelong immune suppressive     medications. HPV vaccination is effective in the prevention of cervical cancer and is now     recommended for all females aged 9-26 years by Alberta Health and Wellness and the Canadian     National Advisory Committee on Immunization (NACI). However, how well the vaccine works in     transplant patients is not known.      This study is being done to look at response of the immune system to HPV vaccine in men and     women up to the age of 35 who have had an organ transplant. Men are also included in this     study because they have the potential to get anal / genital warts and transmit the virus to     their partners. The total duration of the study is three years. Fifty female and male solid     organ transplant recipients (lung, heart, liver, kidney, pancreas, small bowel or combined     organ transplants) on immunosuppression will be enrolled in the study.   "
215935|NCT00677690|"     The purpose of this study is to elucidate whether combination of usual pulmonary     rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise     capacity in patients affected by chronic obstructive pulmonary disease (COPD).   "
215936|NCT00677703|"     Teen girls and young women taking birth control pills may forget to take their pills or may     stop taking them altogether. This places them at risk for unintended pregnancies. Most young     women own cell phones and use them for text messaging. We will test whether contraceptive     continuation is affected after six months of daily text message reminders.   "
215937|NCT00670358|"     RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer     cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Drugs used in     chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving lenalidomide together with rituximab and combination chemotherapy     may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide     when given together with rituximab and combination chemotherapy and to see how well they work     in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large cell     or follicular B-cell lymphoma.   "
215940|NCT00670397|"     RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells.     The drug becomes active when it is exposed to light. When the drug is active, tumor cells are     killed.      PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic     therapy using HPPH in treating patients with recurrent dysplasia, carcinoma in situ, or stage     I oral cavity cancer.   "
215941|NCT00670410|"     Neuroblastoma is a malignant tumor of the sympathetic nervous system. It is the second most     common malignant tumor of childhood. Although modest advances have been made over the past 20     years children with high-risk neuroblastoma continue to have an unsatisfactory long-term     survival. This study will administer induction chemotherapy followed by high-dose     (myeloablative) chemotherapy with autologous stem cell transplantation, followed by radiation     therapy, then immunotherapy with a non myeloablative allogeneic stem cell transplant for     treatment of neuroblastoma. The purpose of this clinical research trial is to study the     feasibility of giving immunotherapy with a non-myeloablative allogeneic transplant     (NAT/AlloSCT), following myeloablative therapy and autologous stem cell transplant     (MAT/AutoSCT). This study will also determine the side effects as well as the response rate     for each group of patients (treatment arm).   "
215942|NCT00670423|"     The purpose of this study is determine the highest dose of bortezomib, a new drug for     graft-versus host disease prevention, that can be given in combination with sirolimus and     Tacrolimus, without causing severe side effects. This research is being done because there is     no treatment that is 100% effective in preventing graft versus host disease.      The goals of this study are to:        1. Collect peripheral blood stem cells (PBSCs) from donors for transplant.        2. Determine the largest possible dose of bortezomib that can be given to recipients with          various blood cancers in a safe manner.        3. Monitor the recipient for risk of infection or side affects associated with the          transplant.        4. Monitor the recipient for increased immunity following transplantation.   "
215943|NCT00670436|"     The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting     PTCA-balloon in combination with bare-metal stenting for treatment of chronic total     occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.   "
215944|NCT00670449|"     This study was an extension study of NCT00537082. This study was designed to evaluate the     efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720)     to relapsing multiple sclerosis.   "
215945|NCT00670462|"     This study is a randomized clinical trial comparing state-of-the-art, standard behavior     therapy for weight loss (SBT) with a maintenance tailored treatment (MTT) with varied     behavioral prescriptions, goals, and formats over time. The overall hypothesis in the study     is that the two treatment approaches will show different patterns of weight loss over time,     and in particular that the MTT approach would be associated with better long-term maintenance     of weight loss.   "
215946|NCT00670475|"     this is a randomized double blinded trial which is conducted to measure the efficacy of     topical virgin olive oil on osteoarthritis of knee that will be done in contrast to standard     piroxicam gel.   "
215947|NCT00670488|"     Treatment of patients with locally advanced or metastatic solid tumors who have failed     standard therapy or no other standard therapy exists.   "
215948|NCT00670501|"     The primary objective of this study is to demonstrate a reduction in the proportion of new     vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment     with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and     vitamin D alone.   "
215949|NCT00670514|"     Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking     cessation support in a dental clinic setting.      Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment     intensity (HTI).      Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183     days).   "
215950|NCT00670527|"     The objective of this trial is to assess the value of 18F-choline PET/CT for the detection of     regional lymph node metastases from prostate cancer. In addition, the investigators want to     evaluate whether 18F-choline PET/CT can replace lymphadenectomy for the staging of prostate     cancer.   "
215951|NCT00670540|"     The purpose of this study is to determine different risk factors of thromboembolic disease.     Different points will be studied        1. do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT),          proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical          significance (risk factors and prognosis) ?        2. Is it necessary to obtain a detailed history of thromboembolic disease ?        3. Do older patients have particular risk factors ?        4. Do preventive treatments modify the level of risk factors and the clinical signs of          thromboembolic disease ?        5. Do predictive clinical scores have the same performance for both in and outpatients ?        6. Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but          no clinical thromboembolic symptoms, develop a low risk ?        7. The evolution of the disease in patients with negative or positive Venous          ThromboEmbolism (VTE) exploratory tests.   "
215952|NCT00670553|"     The purpose of this study is to assess the feasibility of combined administration of     different LBH589 dosages with radiotherapy in order to establish the dosage to be evaluated     in future studies.   "
215953|NCT00670566|"     The primary objective is to evaluate the antihypertensive efficacy of a fixed combination of     Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive     patients.      The secondary objective is to get systolic blood pressure and diastolic blood pressure goal     attainment rate from CoAprovel in Chinese hypertensive patients.   "
215975|NCT00677729|"     Inhaled 3% hypertonic saline (HS) administered every 2-8 hours to infants admitted to     hospital with viral bronchiolitis has been shown to improve airway clearance and reduces     length of stay.      Hypothesis: When infants first present to the ER, frequent administration of HS over a brief     time period will provide significant symptom improvement such that the need for hospital     admission will be reduced.      Objective: To determine in a randomized, controlled and double-blind fashion if the short     term intensive use of inhaled 3% hypertonic saline (HS) in the Emergency Room (ER) can reduce     the rate of hospital admission for infants presenting with moderately severe viral     bronchiolitis.   "
215976|NCT00677742|"     The purpose of this study is to determine whether getting more packs of birth control pills     leads to improved continuation, when compared with getting the traditional supply.   "
215954|NCT00670579|"     Pulmonary infections are the major cause of mortality and morbidity in cystic fibrosis (CF);     patients frequently have to take antibiotics which often cannot be given orally or by aerosol     but have to be administered intravenously. In order to reduce the number of venepunctures,     totally implanted venous access devices (TIVAD) or Ports have been used to administer     antibiotics and other infusions.      The use of Port systems has been increasing in recent years, especially for those patients     requiring frequent intravenous treatments. Having a TIVAD in place makes venous access     quicker and also reduces trauma, suffering and pain. However, there are important     complications associated with TIVADs which can be early (pneumothorax, arterial puncture,     severe bruising) or late (infections, thromboembolic complications and occlusion).      Although the use of TIVADs in CF is increasing, there is little CF-specific literature     available on the epidemiology and risk of TIVAD complications. Also, literature is scarce     about clinical criteria for deciding to insert a TIVAD. Therefore, so far clinical decisions     were based mainly on experiences of TIVAD use in other diseases, such as cancer.      With this prospective observational study we will survey a large population of Italian CF     people with TIVAD in order to: collect data about current clinical conditions of CF people     with TIVAD; investigate about clinical criteria that led to the decision of positioning a     TIVAD; observe the possible onset of late complications.   "
215955|NCT00670592|"     This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults     with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.   "
215956|NCT00670605|"     RATIONALE: Gathering information about the number of young patients with cancer and the     outcome of these patients may help doctors learn more about cancer.      PURPOSE: This research study is looking at the medical records of young patients undergoing     cancer treatment at the Vanderbilt-Ingram Cancer Center to determine how often cancer occurs     and the outcome of these patients.   "
215959|NCT00670644|"     RATIONALE: Identifying why patients don't do self care for lymphedema may help doctors plan     better at-home self-care treatment.      PURPOSE: This research study is looking at self-care practices for lymphedema in patients     with breast cancer.   "
215960|NCT00670657|"     Patients will receive 2mg/kg/day IV daily administration of AmBisome® over 30-60 minutes as a     reaction to signs/symptoms and positive Candida culture   "
215961|NCT00670670|"     Influence of CPP-ACP paste on the evolution and appearance of white spot lesions in     orthodontic patients after removal of the fixed appliances.   "
215962|NCT00670683|"     This study is conducted in Asia. This study is a prospective, open, uncontrolled,     observational surveillance study with Levemir® FlexPen® conducted in Korea.      The aim of this observational study is to evaluate the short term and the long term safety     and efficacy of Levemir® FlexPen®. The study is planned and conducted as per requirement from     Korea Food and Drug Administration (KFDA).   "
215963|NCT00670696|"     Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of     tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute     application time for venopuncture and a 45 minute application time for venous cannulation.     The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in     preventing venous cannulation related pain when applied for the recommended treatment     durations of 30 minutes and 45 minutes respectively.   "
215964|NCT00670709|"     The pace of basic science research defining the mechanisms of selective neuronal degeneration     in Huntington disease (HD) has far exceeded the pace of translation of this information into     clinically effective treatments for the disease. One reason for this bottleneck between bench     and bedside is the paucity of available surrogate markers for HD. Identification of surrogate     markers is critical for the design of future clinical trials. Such markers could provide a     reliable signal of early brain dysfunction in HD and could be used as a biomarker in trials     of agents that could prevent onset or delay progression of disease.      Frontal-subcortical networks are known to be affected in HD and contribute to the cognitive     dysfunction characteristic of the disease. Quantitative EEG (QEEG) can be used to assess the     integrity of this circuitry; characteristic QEEG abnormalities long have been known to be     present in the early stages of the illness (Bylsma et al., 1994). More recent research has     suggested that a comprehensive topographic approach to QEEG analysis may reveal additional     changes in brain activity (Bellotti et al., 2004) that may be indicative of subclinical     disease (de Tommaso et al., 2003). This proposal aims to determine whether quantitative EEG     techniques can be used to identify HD-specific abnormalities and thus serve as surrogate     markers of disease.      The goals of this pilot project are three-fold. First, we will determine if there are QEEG     differences between normal control subjects and those with mild or moderate HD. Second, we     will examine associations between severity of HD and the QEEG differences detected and     determine if these QEEG differences are present when comparing the least affected HD subjects     and normal controls. Third, we will examine associations between QEEG variables of interest     and other clinical variables, including age of onset of symptoms, number of CAG repeats,     severity of motor and behavioral symptoms as measured by the Unified Huntington Disease     Rating Scale (UHDRS) subscores, and severity of cognitive impairment as measured by the     cognitive subscore of the UHDRS and Mini-Mental State Examination (MMSE).   "
215965|NCT00670722|"     This study is conducted in Europe. An observational study evaluating the blood glucose     control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment     of Type 2 diabetes mellitus in Czech Republic.   "
215977|NCT00677755|"     The purpose of this study is to compare the efficacy, safety and acceptability of     pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical     termination of pregnancy by mifepristone EC failure.   "
216016|NCT00679146|"     Primary Objective :      To demonstrate the superiority of the oral fixed - combination of a muscle relaxant,     thiocolchicoside (TCC) to a non steroidal anti-inflammatory drug, ketoprofen, over oral TCC,     on average pain within the last 24 hours in adults suffering from acute non specific low back     pain with an episode of recent onset      Secondary Objective :      To compare the safety of the oral combination to that of oral TCC alone   "
251694|NCT01149785|"     The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the     single dose pharmacokinetics of crizotinib in healthy volunteers.   "
215966|NCT00670735|"     The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic     funding to conduct multi-institutional research (clinical trials and observational studies)     on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has also received     an NIH NINDS Challenge Grant to support the network infrastructure which allows for the     conduct of this and other network studies. The HCRN consists of multiple Clinical Centers and     the Data Coordinating Center (DCC). The HCRN Core Data Project will obtain data about all     neurosurgical hydrocephalus events from the network Clinical Centers, and create a database     to be used by HCRN investigators. The ongoing maintenance of the Core Data Project serves two     main purposes: 1) it will help investigators understand the variability, progression, and     current treatment practices for hydrocephalus in children, with an ultimate goal of better     guiding and assessing therapeutic intervention and providing recommendations on patient care     and, 2) it will provide pilot and descriptive data necessary for hypothesis generation and     study design (i.e. preliminary power analyses, recruitment projections) for studies under     development by the HCRN. This multi-institutional database will be maintained throughout the     lifetime of the HCRN, and may be useful for tracking trends in pediatric hydrocephalus over     time. The Core Data Project will be an invaluable resource to the HCRN and will help     stimulate new research protocols, identify potential need for future expansion of the network     to incorporate additional patient populations, and provide a descriptive understanding of     children with hydrocephalus cared for within the network.   "
215982|NCT00677820|"     This prospective annual release study was designed to assess the safety of a trivalent     influenza virus vaccine using a new strain recommended for the 2008-2009 influenza season not     previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy     adults received a single dose of vaccine or placebo and were followed for 180 days.   "
215983|NCT00677833|"     The primary objective is to confirm the hypothesis that azithromycin used in combination with     chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic,     uncomplicated malaria due to P. falciparum in children in African countries.   "
215991|NCT00677937|"     The study aims to identify people at high diabetes risk within the local population and then     implement and evaluate a pragmatic and low-cost diabetes prevention programme containing     structured education on lifestyle, physical activity and food choices. An ongoing support     framework will continue to reinforce and maintain the participant's individual goals to     prevent the development of diabetes and reduce cardiovascular risk.      Therefore the principal question is: can we significantly reduce the incidence of diabetes     through structured education in a high risk multi-ethnic UK population?   "
215967|NCT00670748|"     Background:      -This study uses an experimental cancer treatment that uses the patient s own lymphocytes     (type of white blood cell), which are specially selected and genetically modified to target     and destroy their tumor.      Objectives:      -To test the safety of the treatment and determine if it can cause the patient s tumor to     shrink.      Eligibility:        -  Patients greater than 18 years and less than or equal to 66 years of age whose cancer          has spread beyond the original site and does not respond to standard treatment.        -  Patients have tissue type human leukocyte antigen (HLA)-A*0201.        -  Patients cancer cells have the ESO-1 gene.      Design:        -  Workup: Patients have scans, x-rays, laboratory tests, and other tests as needed.        -  Patients have leukapheresis to collect cells for laboratory treatment and later          reinfusion. For this procedure, whole blood is collected thorough a tube in a vein, the          desired cells are extracted from the blood, and the rest of the blood is returned to the          patient.        -  Chemotherapy: Patients have low-dose chemotherapy for 1 week to prepare the immune          system to receive the treated lymphocytes.        -  Cell infusion and aldesleukin (IL-2) treatment: Patients receive the lymphocytes by a          30-minute infusion through a vein. Starting within 24 hours of the infusion, they          receive high-dose aldesleukin infusions every 8 hours for up to 5 days (maximum15          doses).        -  Recovery: Patients rest for 1 to 2 weeks to recover from the effects of chemotherapy and          aldesleukin.        -  Tumor biopsy: Patients may be asked to undergo a biopsy (surgical removal of a small          piece of tumor) after treatment to look at the effects of treatment on the immune cells          in the tumor.        -  Follow-up: After treatment is completed, patients return to the clinic once a month for          several months for physical examinations, a review of side effects, laboratory tests and          scans. They may undergo leukapheresis at some visits to look at the effect of treatment          on the immune system and check the viability of the infused cells. Patients then return          to the National Institute of Health (NIH) clinic once a year for 5 years and then          complete a follow-up questionnaire for another 10 years.        -  Retreatment: Patients whose tumor shrinks or disappears following treatment and then          recurs may receive one additional treatment, using the same regimen of chemotherapy,          lymphocyte infusion and IL-2 treatment.   "
215968|NCT00670761|"     This randomized study will examine the efficacy, safety and acceptability of misoprostol for     treatment of incomplete abortion.      Women diagnosed with incomplete abortion will be randomized to receive one of the following     regimens:      In Tanzania and Mozambique:        1. 600 mcg of oral misoprostol in one dose, or        2. Standard surgical treatment (MVA)      In Moldova and Madagascar:        1. 600 mcg of oral misoprostol in one dose, or        2. 400 mcg of sublingual misoprostol in one dose.      In Burkina Faso and Vietnam:      1. 400 mcg of sublingual misoprostol in one dose.      We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual     misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.   "
215969|NCT00670774|"     A strongly positive crossmatch has long been considered an absolute contraindication to     kidney transplantation and most patients with anti-HLA antibody never were able to receive a     kidney transplant. Over the past decade, significant progress has been made in overcoming     early antibody-mediated renal allograft injury. Our group has performed more than 200 such     transplants providing the possibility of transplant to previously untransplantable patients.     Despite our best efforts, transplantation in these patients is still complicated by a high     rate of acute humoral rejection.      Patients included in this study will be those who have demonstrable anti-HLA antibody     specific for their living donor. It is our hypothesis that blockade of terminal complement     activation at the time of transplant in combination with our current protocols will reduce     the incidence of AHR in patients with anti-donor HLA antibody.   "
215970|NCT00670787|"     The purpose of the study is to determine whether combination pill of losartan potassium and     hydrochlorothiazide will improve medication compliance among patients with high blood     pressure.   "
215971|NCT00670800|"     The purpose of this study is to evaluate the effects of insulin resistance on brain function     in women with Polycystic Ovary Syndrome (PCOS). PCOS affected women will be evaluated prior     to and following 4-month treatment with Metformin. Additionally, brain function in women with     PCOS will be compared to the brain activity in normal control subjects with regular menstrual     cycles.   "
215972|NCT00670813|"     The study aims to investigate whether the administration of the stimulant modafinil during a     40 hour sleep deprivation period in depressed patients can intensify the antidepressant     effect of the sleep deprivation as assessed by a reduction in the Hamilton Depression score     (HAMD, 6-item version). We postulate that this also correlates with a reduction of the     polysomnographically assessed overall amount of sleep during this period.   "
215973|NCT00670826|"     Medications used to put people to sleep during surgical procedures also cause changes in the     body's ability to control its temperature. These changes can make a person's temperature drop     below normal. To minimize this drop in body temperature, different types of body warming     products are used during surgery. This study is designed to compare the the temperatures of     people under general anesthesia after 60 minutes of warming with each product. The study     hypothesis is that the people warmed with the Dynatherm Medical vitalHEAT vH2 System will     decrease less in the first 60 minutes of warming time than people warmed with the Arizant     Bair Hugger System.   "
215974|NCT00677716|"     Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a     targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and     deliver radiation directly to the center of the tumor mass while minimizing effects on normal     tissues. Cotara® thus literally destroys the tumor from the inside out. This may be an     effective treatment for glioblastoma multiforme, a malignant type of brain cancer.   "
251695|NCT01149798|"     This phase II trial on the assumption that abraxane and cisplatin combination therapy is     efficacy in metastatic breast cancer.   "
215978|NCT00677768|"     The purpose of this study is to collect 650 blood and 300 cerebrospinal fluid (CSF) samples     from people with amyotrophic lateral sclerosis (ALS), pure lower or upper motor neuron     diseases, as well as other neurodegenerative diseases and from people with no neurological     disorder. Through comparison of these samples, the researchers hope to learn more about the     underlying cause of ALS, as well as find unique biological markers, which could be used to     diagnose ALS and monitor disease progression.      Additionally, up to 600 blood samples will be collected for a sub-study for DNA analysis.     Studying components of the blood, such as DNA, may help us understand what happens when genes     function abnormally and how it might be related to disease.   "
215979|NCT00677781|"     Microparticles are cellular fragments which are released actively or passively under     conditions of inflammation and stress. The impact of surgical operations on quantity and     quality of microparticles remains unknown. In this observatory study we investigate     quantitative and qualitative aspects of microparticles during cardiac and abdominal     operations.   "
215980|NCT00677794|"     There remains debate regarding whether small bowel cleansing is required prior to video     capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing     with no preparation, preparation with picosalax, and preparation with polyethylene glycol.   "
215981|NCT00677807|"     This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against     placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients   "
215984|NCT00677846|"     Background:      During the repair process of deep venous thrombosis, capillary formation is seen from day 18     to day 25. Contrast agent investigation is well known to detect small vessels in arterial     disease. We intend to use this method to detect early vascularisation in the thrombus, in     order to get more information about the evolution of the thrombosis in vivo.      Aims of the study:      Investigation of a newly diagnosed occluding venous thrombus with duplexsonography, using     contrast agent and compare the degree of vascularization in the same patient after 3 weeks     and 3 months. The relative signal intensity difference (baseline to peak) of the time     intensity curve (TIC) is measured in defined region of interests (ROI). Comparison of the     visibility of revascularisation between color duplexsonography, power mode and contrast agent     will be done.      Method:      Patients with venous thrombosis of the proximal limb veins (femoral or popliteal vein) will     be investigated with ultrasound agent in supine position. 5 ml of the contrast agent sulfur     hexafluoride is given intravenously into a vein of the dorsal foot. The measurements are done     in a defined area, where the thrombus is fully occluding in color Doppler investigation. The     regions of interest will be the vessel walls and the centre of the thrombus in cross section     view. The signal intensities are measured at baseline and peak (in decibel) in the centre and     in the peripheral part of the vein. 20 patients with acute deep venous thrombosis will be     included in this pilot study and investigated at baseline, after 3 weeks and 3 months.      Previously (before contrast agent application), the veins are investigated with color - and     power Doppler to test visibility in comparison to the contrast agent investigation.   "
215985|NCT00677859|"     The purpose of this study is to determine if MultiStem® can safely be given to patients with     acute leukemia, chronic myeloid leukemia, or myelodysplasia after they have received     hematopoietic stem cell transplantation.   "
215986|NCT00677872|"     A 3-month open label study to evaluate the safety and efficacy of PRX-08066 in patients with     pulmonary hypertension and COPD.   "
215987|NCT00677885|"     This study will measure the function of a protein called P-glycoprotein (P-gp), which is     found at the blood-brain barrier, a membrane that normally prevents toxic material from     entering the brain. Impaired P-gp function may allow toxins to enter the brain and cause some     people to develop certain brain diseases.      Healthy subjects and people with Alzheimer s disease, Parkinson s disease or frontotemporal     dementia who are 35 years of age or older and in overall good health may be eligible for this     study.      Participants undergo the following procedures during three outpatient visits to the NIH     Clinical Center:        -  Medical history, psychological evaluation, physical examination and blood and urine          tests, including tests for illegal and addictive drugs.        -  PET scan: This test uses small amounts of a radioactive chemical called a tracer that          labels active areas of the brain so the activity can be seen with a special camera.          Before starting the scan, a catheter (plastic tube) is placed in a vein in the arm to          inject the tracer. The subject lies on the scanner bed, with a special mask fitted to          the head and attached to the bed to help keep the head still during the scan so the          images obtained are clear. A brief initial scan is done to calibrate the scanner. Then,          a radioactive tracer called [(15)O]H(2)O is injected into the catheter and the PET          camera takes pictures of blood flow to the brain for about 60 seconds. Next, another          tracer, [(11)C]dLop, is injected into the catheter and pictures are taken for about 2          hours to determine how much of this tracer is allowed to enter the brain.        -  Magnetic resonance imaging (MRI): This procedure is done within 1 year (before or after)          the PET scan. MRI uses a magnetic field and radio waves to produce images of the brain.          For this procedure, the patient lies on a table that can slide in and out of the scanner          (a tube-like device), wearing earplugs to muffle loud knocking and thumping sounds that          occur during the scan.   "
215988|NCT00677898|"     The purpose of this study is to determine if individuals with serious mental illnesses     exposed to a patient-centered computerized tool versus printed educational materials have     higher rates of screening for the metabolic side effects of second-generation antipsychotic     medications and different patterns of communication with their prescribers about screening.   "
216012|NCT00679094|"     This randomized phase I trial is studying the side effects and best dose of Bowman-Birk     inhibitor concentrate in healthy men. Chemoprevention is the use of certain drugs to keep     cancer from forming. The use of Bowman-Birk inhibitor concentrate may prevent cancer.   "
216013|NCT00679107|"     This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the     treatment of spinal decompression and lumbar spinal fusion.   "
216014|NCT00679120|"     The purpose of this scientific study is to clarify whether there is a relationship between     the appearance of radiolucent lines in bone-cement interphase of the tibial component of the     different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses.     This will be accomplished in a se-ries of three different Oxford Uni Knees.   "
215989|NCT00677911|"     Principal Investigator/Program Director (Last, First, Middle): Darnall, Beth APS Future     Leaders in Pain Small Research Grants Application Page 5 Continuation Format Page      Summary: Chronic pain is stressful, both physically and psychologically. Stressful     experiences induce autonomic nervous system arousal, which reliably leads to inflammation and     immune suppression. Inflammation then exacerbates existing pain and may be a key factor in     both the genesis and maintenance of pain. Stress-induced immune effects are detected two     hours (2 hrs) post-stressor, suggesting only a few stressful experiences per day may be     sufficient to sustain elevated pain levels1. Cognition has emerged as a potential mediating     factor in the relationship between pain and stress. Mentally recreating an emotionally     stressful event induces de novo physiological stress1. In other words, thinking about an     emotionally charged event down-regulates autonomic stress responses and subsequent immune     effects. Therefore, exploring cognition as a mediating factor between stress, pain, and     inflammation will inform our understanding of pain pathways, as well as improve treatment for     pain.      Study Rationale: The acute stress response induces immunosuppression; however, this     relationship has been studied in arbitrary models only (shock avoidance, job interview). This     study employs the novel approach of examining stress and immune responses to a personally     relevant stressor (pain); prior studies used arbitrary models only (shock avoidance, job     interview). Pain offers a highly salient and personal context well-suited for investigation     of negative cognitive perseveration. Pain is acutely sensitive to exacerbation via     inflammation, and thus the relevance of examining immune effects of rumination on future     negative expectations (expecting the worst) is underscored.      Goal: To test the biological consequences of negative expectations, achieved via an active     10-minute negative cognitive perseveration on a personally relevant stressor: future     worsening of one's chronic pain condition. Biological stress response will be measured via     heart rate (HR), blood pressure (BP) and serum cortisol. Impact of negative cognition on     inflammation will be measured using interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor     necrosis factor-alpha (TNF-α) as biomarkers of immune function, controlling for depression     and pain catastrophizing. This study aims to inform the understanding of pain mechanisms.      Aim 1: Determine the magnitude of an autonomic stress response to an induction of negative     cognition.      Aim 2: Determine immune effects of the experiment-induced stress response.      Aim 3: Establish whether a pre-existing tendency to catastrophize mediates the relationship     between experiment-induced negative perseveration and immune effects.      Aim 4: Establish whether stress-related increases in IL-6 remain elevated post 2 hrs.   "
215990|NCT00677924|"     The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in     combination with Irinotecan for the treatment of patients with Colorectal Cancer   "
215992|NCT00677950|"     The trial was designed to demonstrate the comparability of the overall success rate in the     OP-1 Putty treatment group to the autograft treatment group.   "
216036|NCT00679406|"     The purpose of this study is to adapt and test the effects of a 4-week behavioral treatment     that targets chronic insomnia (lasting >1 month) in service members returning from Operation     Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF).   "
215993|NCT00677963|"     The first goal of this study is to investigate whether CE-US is able to accurately identify     and quantify neovascularisation in carotid artery plaques. Since this is one of the first     studies systematically evaluating the ability of ultrasound in combination with air bubbles     to evaluate neovascularisation in carotid artery plaques, the examination will be performed     twice with an interval of 1/2 hour on the day before surgery, thus studying the reliability     of the method.      The second goal of this study is to investigate whether MRI at 3.0 T with a custom-designed     3T carotid coil, using a recently developed pulse sequence, is able to accurately identify     and quantify neovascularisation. And the third goal of this study is to make an intermodality     comparison of CE-US and MRI regarding their ability to identify and quantify plaque     neovascularisation.   "
215994|NCT00677976|"     The purpose of the study is to map regions of brain activation following rectal stimulation     in children with irritable bowel syndrome (IBS) and healthy controls.   "
215995|NCT00677989|"     The purpose of this study is to conduct a prospective observational study for the open     approach and laparoscopic approach for perforated appendicitis. It is also designed to     investigate if carbon dioxide pneumoperitoneum will have unwanted effect when treating     perforated appendicitis with laparoscopic operation.   "
215996|NCT00678002|"     The goal of this study is to compare parent and child perceptions of wellness and     vulnerability in children who have undergone solid organ transplant. It is hypothesized that     there will be significant differences between parent and child perceptions.   "
215997|NCT00678015|"     This is a Phase II, single center study measuring the pharmacokinetic parameters of NDGA     administration and assessing the proportion of patients who experience a 50% decline in PSA.   "
215998|NCT00678028|"     Due to genetic polymorphism about 15%-30% of the world population have low levels of MBL     (Mannose Binding Lectin) in serum (below 500ng/mL). Different studies reported correlation     between polymorphism in the MBL gene with low levels of MBL in serum and higher frequency of     recurrent infections, severity of sepsis, ARDS and other infections. Urinary Tract Infection     (UTI) is one of the very common infection in women. Since MBL is part of the innate immunity     and there are proofs of relation between patients with recurrent infections and lack of MBL,     we decided to explore a possible relation between low levels of MBL and different genotypes     of MBL in young women and the risk to develop recurrent UTI.   "
215999|NCT00678041|"     Urinary tract infection (UTI) is the most common complication after surgery for prolapse or     urinary incontinence. UTIs are painful and have the potential to turn into kidney infections.     We are asking women who self-catheterize after surgery to try either an antibiotic or a     placebo pill so we can see if we can prevent UTIs without causing side effects.      This study will not require any additional visits or blood draws. You will be asked to answer     some questions, keep a brief diary of your experience, and immediately report any symptoms of     a UTI to your doctor.   "
216000|NCT00678912|"     The purpose of this study is to determine whether a computer-driven system (Smartcare/PS)     decreases weaning duration from mechanical ventilation when compared to usual care in     children.   "
216001|NCT00678925|"     Studies have shown that choline is a necessary part of the human diet. Choline is important     in making membranes for all the cells in the body, and for making chemicals that are     responsible for nerve function. Studies have also shown that choline improves memory of rats     when they are given choline at early stages in their lives. The purpose of this study is to     find out whether choline supplementation (provided as a choline dietary supplement) in     pregnant women will improve memory function of their babies after they are born.      In this study, we hypothesize that high dietary choline consumption during pregnancy and     lactation will:        1. Increase maternal choline concentration in plasma        2. Increase breast milk choline concentration        3. Enhance memory performance in the children born of supplemented mothers   "
216002|NCT00678938|"     The study takes up two problems: 1) Little research exists about general population     interventions for smokers not ready to quit within the foreseeable future. 2) There is little     evidence for smoking reduction as a behavioural goal in interventions. Interventions based on     the Transtheoretical Model of Behavior Change (TTM) using computer expert-system technology     yield delayed and smaller effects in smokers in the precontemplation stage of change compared     to smokers in more advanced stages of change. Reducing the number of cigarettes smoked per     day is currently discussed as an intermediate goal for this subgroup. Epidemiological and     clinical studies revealed that smokers are able to maintain a substantial reduction. No     undermining effects with respect to smoking cessation have been found. However, there are no     studies that test the efficacy of behavioural interventions for smoking reduction using     population based recruitment. Objectives: Testing the efficacy of TTM based interventions for     general population smokers not intending to quit smoking, i.e. a smoking-reduction and a     smoking-cessation tailored intervention using computerized expert-system technology.   "
216003|NCT00678964|"     60% of all malignant diseases occur in patients who are 65 years or older. For these     patients, aggressive treatments are often not suitable due to reduced life-expectancy,     reduced general condition, comorbidities, and reduced vital functions which can lead to     increased adverse effects of chemotherapy. Therefore, it is important to investigate     alternative therapy options for elderly patients.      Erlotinib is an orally applied medication which is associated with reasonable toxicity. This     targeted agent may prove an effective and well-tolerated first-line therapy in elderly     patients with advanced non small cell lung cancer.      Therefore, the aim of this study is to investigate the progression-free survival of the     combination of vinorelbine and carboplatin in comparison to erlotinib. Given that there will     be no significant reduction of efficiency this may provide elderly patients of more than 70     years of age with an active oral substance without subjecting them to the sometimes severe     adverse effect of the chemotherapy.   "
216064|NCT00679770|"     The purpose of the study is to determine the safety and efficacy of 2.5%, 5.0%, and 7.5%     AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual     onychomycosis of the great target toenail.   "
216065|NCT00679783|"     This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with     recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers     to identify objective response rate and to assess for early markers of activity and to assess     correlative markers that may provide helpful information for subsequent clinical trials.     Approximately 110 patients from 7 centers in Canada will be enrolled into this study.   "
216004|NCT00678977|"     This is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and     tolerability and to determine the optimal tolerated regimen(OTR) of pazopanib in combination     with gemcitabine (Arm A) or pazopanib, gemcitabine, and cisplatin (Arm B) in patients with     advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses     of pazopanib and gemcitabine or pazopanib, gemcitabine and cisplatin. Dose escalation schemas     for each study arm are described in the protocol. For each arm, the OTR will be defined as     the highest dose combination of the agents where no more than one out of six patients     experiences a dose-limiting toxicity. Six to twelve additional patients in each arm will be     studied with the OTR to evaluate toxicity and pharmacokinetics. This will allow an assessment     of potential drug-drug interactions. Antitumor activity will be assessed using RECIST     criteria.   "
216005|NCT00678990|"     In this study the islets will be surface modified to carry immobilised heparin (Corline     Heparin Conjugate) prior to transplantation. The primary objective is to investigate safety     and efficacy of allogeneic islet transplantation using islets coated with immobilised     heparin. The modification with heparin has been shown to protect the islets from being     attacked by the immediate defence systems in blood (coagulation and inflammation), so that a     larger portion of the islets will survive the initial phase and engraft. Evaluation will be     based on metabolic and blood chemistry parameters.   "
216006|NCT00679003|"     Inflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in     significant life disruption, hospitalization and surgery. While psychosocial factors are not     believed to cause IBD, such factors can contribute to the ability of individuals with IBD to     cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms.     The goal of this study is to evaluate the efficacy of a social learning and cognitive     behavior therapy approach for treating children with IBD. The primary outcomes of interest     are IBD symptoms, medical visits, quality of life, and overall disability.   "
216007|NCT00679029|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide,     paclitaxel, and gemcitabine hydrochloride, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as bevacizumab, can block tumor growth in different ways. Some block the ability of     tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by     blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab     after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying the side effects and how well giving combination     chemotherapy together with bevacizumab works in treating women with HER2/neu-negative stage     II or stage III breast cancer   "
216008|NCT00679042|"     In an earlier Phase 1/2 clinical trial using the Edmonton Protocol of steroid free     immunosuppression, investigators at University of Illinois at Chicago (UIC) demonstrated the     safety of islet preparation, iset transplantation, and medical treatment at UIC. Therefore,     the primary purpose of the present Phase 3 clinical trial is to demonstrate the safety and     efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic     patients using the UIC protocol that was developed and proven effective during the Phase 1/2     clinical trial.   "
216009|NCT00679055|"     A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary     hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a     decrease in lower extremity atherosclerotic plaque macrophage content when compared to     placebo (an approximate decrease of up to 30% is expected).   "
216010|NCT00679068|"     Bosentan has been largely used in the treatment of pulmonary hypertension (PH). It can     improve exercise capacity, lower Borg dyspnoea score nad these effects are usually associated     with the concomitant improvement in cardiopulmonary haemodynamics.      No physiological study has so far verified the hypothesis that Bosentan may laso have an     effect on the respiratory side of the cadio-pulmonary system (i.e. on pulmonary mechanics     and work of breathing)   "
216011|NCT00679081|"     The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in     the treatment of subjects with Miller Class I or II recession defects who desire root     coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative     to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and     wound healing.   "
216017|NCT00679159|"     This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children     and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and     highly immunogenic in a wide range of subjects in previous clinical trials. In this trial,we     will vaccinate 24 children with 5 x 10^7pfu of MVA85A and three groups of 36 infants with 2.5     x 10^7, 5 x 10^7 or 1 x 10^8 pfu.      Participants will be identified from the general population living in Worcester, Western     Cape, South Africa   "
216018|NCT00679172|"     This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever     vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility.     The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.   "
216019|NCT00679185|"     RATIONALE: Expressive writing may help relieve symptoms and improve quality of life in breast     cancer survivors with chronic lymphedema.      PURPOSE: This clinical trial is studying expressive writing in improving the quality of life     in women with breast cancer and lymphedema.   "
216034|NCT00679380|"     This will be a multicentre, randomised, double-blind, double-dummy, parallel group     comparative study in patients with mild or moderate, active ulcerative colitis. The study     will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to     Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment     period.      After the screening visit, patients will enter a washout period of 2 days, then they will be     randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg),     budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and     capsules), all administered once a day after breakfast. Hence, each patient will receive, in     the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet     and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo     budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three     placebo Entocort® matching capsules.   "
216020|NCT00679198|"     SPECIFIC AIMS: We propose a three-year study to develop a high-intensity intervention to     improve osteoporosis care and test a novel intervention in a group-randomized trial of 27     home health offices and 1,000 patients referred to home health care with a history of     fracture.      Aim 1. Develop an intervention to promote osteoporosis treatment that includes: (1) training     to enhance nurse-patient and nurse-physician risk communication regarding osteoporosis and     fracture risk; (2) automated prompts within the home health agency's electronic medical     record system to promote appropriate osteoporosis management; and (3) implementation of     osteoporosis-related standardized care pathways and order sets.      Aim 2. Conduct a group-randomized trial to test the effectiveness of the intervention to     promote initial use of osteoporosis medications and adherence to treatment after discharge     from home health. We hypothesize that:      H1: Patients in the intervention group will have increased initial receipt of osteoporosis     prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis     compared to patients receiving usual care; H2: Patients in the intervention group will     demonstrate increased persistence in the use of these therapies compared to those receiving     usual care.      Secondary Aims (SA) will include exploratory analyses of fracture related morbidity and     mortality, patient-reported quality of life, and health services utilization and costs.   "
216021|NCT00679211|"     Study of trastuzumab emtansine (T-DM1) administered to patients with human epidermal growth     factor receptor 2 (HER2)-positive metastatic breast cancer.   "
216022|NCT00679224|"     The purpose of the programme is to collect safety data on ambrisentan when used in clinical     practice   "
216023|NCT00679237|"     Study hypothesis: Multifactorial risk reduction in coronary heart disease can reduce the risk     of new coronary heart disease and death   "
216024|NCT00679250|"     Allergic rhinitis is a common condition characterize by inflammation of the upper airways.     Third generation antihistamines have been demonstrated effective in the treatment of this     condition. Allergen challenge can be use to assess the effects of drugs in allergic rhinitis,     adenosine monophosphate may also be used as a means to investigate these effects but as yet     its effects have yet to be compared to allergen challenge. We intend to compare the effects     of levocetirizine at a single dose of 5mg on allergen and AMP challenge compared to placebo     in a double blind cross-over study. The study will include 20 patients with allergic     rhinitis. Each patient will have allergen and AMP challenge on placebo and active treatment.     The primary outcome variable will be the change in concentration of AMP/Allergen required to     produce a 20% drop in nasal flow as manifest by peak nasal inspiratory flow. A 1 doubling     dose change in concentration of challenge medium to cause a 20% drop in nasal flow will be     deemed significant. We will also measure time to recovery after both challenges. AMP     challenge is a safe alternative to allergen challenge and does not have the risk of     anaphylaxis.   "
216025|NCT00679263|"     The purpose of this study is to evaluate the safety and tolerability of MN-221 at two     different dosing rates administered through a continuous infusion in subjects diagnosed with     moderate to severe asthma.   "
216026|NCT00679276|"     Chart review conducted on all patients having had Prolift surgery since 2005 by Dr. Lary     Sirls, Dr. Predeep Nagaraju and Dr. Kenneth Peters at William Beaumont Hospital.   "
216027|NCT00679289|"     This study will evaluate the safety and effectiveness of the combination regimen of KW2871     and high dose Interferon-alfa2b (HDI) in patients with metastatic melanoma (skin cancer that     has spread to other parts of the body).      KW2871 is an antibody that is made in a laboratory. Antibodies are part of the immune system.     KW2871 attaches to the GD3 ganglioside (a molecule that is found on melanoma cells). This may     help slow or stop the growth of melanoma tumors.      Interferon-alfa 2b is a man-made version of interferon. Interferons are among a number of     substances produced by the immune system in response to the presence of enemy cells. Not only     does it interfere with foreign invaders that may cause infection, but it can prevent the     growth and spread of other diseased cells as well, including some types of cancer cells.     Interferons have been shown to be effective against a variety of tumors.   "
216028|NCT00679302|"     The purpose of this study is to determine if antibiotics are required in the management of     skin abscess following incision and drainage.   "
216029|NCT00679315|"     The purpose of this study is to explore the efficacy of Alfuzosin (10 mg, qd) in reducing the     score of International Prostate Symptom Score (IPSS) from baseline to 8 weeks of treatment in     female patients with voiding dysfunction.   "
216030|NCT00679328|"     This study is to evaluate the safety and effectiveness of the OP device for the treatment of     nonunion bone fractures and to compare the healing rates of the OP Device to that of     autograft.   "
216031|NCT00679341|"     This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial     designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the     combination of trastuzumab and docetaxel in patients with human epidermal growth factor     receptor 2 (HER2)-positive, unresectable, locally advanced breast cancer and/or metastatic     breast cancer who have not received prior chemotherapy for metastatic disease.   "
216032|NCT00679354|"     This phase II trial studies how well cilengitide works in treating younger patients with     recurrent or progressive high-grade glioma that has not responded to standard therapy.     Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.   "
216033|NCT00679367|"     RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different     ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping     them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune     system in different ways and stop the abnormal plasma cells from growing. Giving melphalan     together with lenalidomide and dexamethasone may be an effective treatment for primary     systemic amyloidosis.      PURPOSE: This phase II trial is studying the side effects and how well giving melphalan     together with lenalidomide and dexamethasone works in treating patients with primary systemic     amyloidosis.   "
216035|NCT00679393|"     A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres     across Canada. It will compare patients who receive open reduction, internal fixation for     Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same     type of fracture. Patients will be followed up for a period of two years from the time of     operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12     months, and 24 months.   "
216037|NCT00679419|"     It is the aim of the multi-centric and prospective registry to analyze in patients with CAD     the impact of different grades of renal failure on the outcome and course of the patients and     to correlate these with clinical variables.      In particular, the registry has the following objectives:        -  prospective consecutive assessment of all patients with coronary artery disease and          renal failure in the participating hospitals of the registry        -  evaluation of the outcome and course of patients with regard to their different stages          of renal failure at baseline        -  analysis of the impact of different therapeutic strategies on acute and long-term          outcomes        -  identification of clinical risk factors, novel biomarkers and genetic markers for an          unfavorable long-term outcome   "
216038|NCT00679432|"     The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets     to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if     Budesonide MMX™ is effective in the treatment of ulcerative colitis.   "
216039|NCT00679445|"     The objective of this clinical study is to evaluate the safety and feasibility of focal     delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) in     patients with age related macular degeneration that have failed Primary Anti-VEGF therapy.   "
216040|NCT00679458|"     This study compares two medications for analgesic potency and side effects in a sample of     individuals with moderate pain. After screening, eligible participants will be randomly     assigned to begin blinded treatment with one of two medications. Participants receive 5 daily     doses of medication (no more than 2 days between each dose) followed by crossover to the     opposite treatment condition for 5 additional daily doses. Each study day, participants will     provide a daily pain assessment, receive administration of study medication, and will then be     monitored and assessed for pain and side effects over 6 hours.   "
216041|NCT00679471|"     The purpose of this study is to see how full-term and pre-term infants' brains relate to     their movement and development throughout the first two years of life. All infants who     participate in this study will have a magnetic resonance image (MRI) of the brain prior to     discharge from the hospital. Infants will then have follow-up appointments every 3-6 months     at home or at the Infant Motor Behavior Laboratory at the University of Delaware. The     follow-up sessions will test how infants change their movements to respond to interesting     objects or sounds in their environment. It is hoped that the results of this study will     assist clinicians in developing better testing and treatment methods for those infants at     risk for developmental problems.   "
216042|NCT00679484|"     This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a     prognostic biomarker of heart failure, at week 24   "
216043|NCT00679497|"     The purpose of this clinical trial is to study a modified pox viral vector considering:        1. HIV subtype B accounts for the most frequent virus strain in Europe and North America,          as well as in many parts of the world.        2. This novel vaccinia construct expressing HIV subtype B gag, pol, env and nef antigens is          to be studied in humans for the first time.   "
216044|NCT00679510|"     Patients with rheumatoid arthritis are at increased risk of having cardiovascular deaths. Our     study is aimed at looking at the effects of proven cholesterol lowering treatment drug called     rosuvastatin in rheumatoid arthritis patients on few cardiovascular markers. Endothelial     behaviour improved on treatment.   "
216045|NCT00679523|"     The purpose of the study is to determine the safety and efficacy of 5.0% and 7.5% AN2690     Solution in the treatment of distal, subungual onychomycosis of the great target toenail.   "
216046|NCT00679536|"     The study proposes the use of Fludarabine, Busulfan, Anti Thymocyte Globulin Rabbit (ATG) and     Total Body Irradiation as a preparative regimen before hematopoietic stem cell transplant     from unrelated donor peripheral blood stem cells (PBSC). The hypothesis states that the 100     day mortality after this type of transplant will be significantly below the accepted     standards, which is about 30% for unrelated donors.   "
216163|NCT00681096|"     An examination of the various factors that cause lower back pain in nurses in four hospitals     in Israel such as; socio-demographic, professional, posture while ambulating patients and job     environment.   "
216047|NCT00679549|"     This study will evaluate whether treating sleep apnea while in the hospital would help heart     failure, and assist recovery from the worsening of the heart function more than the current     clinical standard of waiting for treatment until the subject have left the hospital.      Heart failure affects more than 2% of the US population and is the only cardiovascular     disorder with rising incidence. The annual cost of CHF in 2005 was $ 27.9 billion, large     percentage of which is the cost of hospitalizations for exacerbation of CHF. Half of patients     with CHF have some form of sleep apnea, and most of them go undiagnosed. Patients with CHF     and OSA benefit from treatment with CPAP as an outpatient. The society can benefit from     developing recommendations for approaching sleep apnea in the hospitalized CHF patient, which     may shorten length of stay, improve functional status of discharged patient, and reduce     rehospitalizations.   "
216048|NCT00679562|"     Primay objective:      To evaluate the potential of the products in eliciting adverse skin reaction.   "
216049|NCT00679575|"     The main objective of this case-referent study is to assess the impact of statins usage on     the risk of having a first myocardial infarction (MI) in a real life situation in France   "
216050|NCT00679588|"     The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous     (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for     the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal     surgery.      The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to     document Semuloparin sodium (AVE5026) exposure in this population.   "
216051|NCT00679601|"     The purpose of the study is to determine the absorption and systemic pharmacokinetics of     AN2690 following daily application to all ten (10) toenails for 28 days.   "
216066|NCT00679796|"     This study is undertaken to evaluate the effectiveness of currently licensed varicella     vaccines under conditions of routine use in a setting where varicella vaccine is included in     the childhood immunization calendar.   "
216067|NCT00679809|"     The purpose of this study is to describe the features of continuity and quantify fatigue in     three ICU resident work schedules, estimate the frequency of preventable adverse events, and     inform the design and demonstrate the feasibility of a future multi-centre study.   "
216052|NCT00679614|"     Patients over 70 years of age, scheduled for joint replacement surgery will be randomized to     tramacet/ naloxone plus morphine PCA or to morphine PCA to assess quality of analgesia in the     postoperative period.      The primary objective is to determine opioid use during combined use of oral tramacet and     naloxone infusion perioperatively in elderly patients (70 yrs and older) having elective     knee/ hip arthroplasty under spinal anesthesia.      Secondary objectives are to determine the incidence VAS scores ≥4 and adverse effects such as     nausea, vomiting, sedation, respiratory depression, pruritus, confusion, and time of     independent mobilization.      Hypothesis: Perioperative naloxone infusion and tramacet provides adequate analgesia in     elderly patients undergoing total knee/hip arthroplasty and is associated with 80% reduction     in opioid use and reduced opioid-induced side effects.   "
216053|NCT00679627|"     The purpose of this study is to compare the effectiveness and safety of 2 years of treatment     with galantamine as compared with placebo of patients who have mild to moderately severe     Alzheimer's disease (AD).   "
216054|NCT00679640|"     The purpose of this study is to describe the way candesartan is used in heart failure     treatment in France (treatment initiation and monitoring), treatment stops occurrence and     reasons for and patients clinical evolution   "
216055|NCT00679653|"     To study the effect of sibutramine treatment on weight reduction and blood pressure     improvement in three groups with antihypertensive therapy whose blood pressure was not     adequately controlled with antihypertensive combination treatment.   "
216056|NCT00679666|"     Prospective, randomized, single site to determine the safety and effectiveness of performing     corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive     keratoconus or corneal ectasia.   "
216057|NCT00679679|"     Polycystic ovary syndrome is a frequent cause of abnormal menses and infertility. It has also     been related to cardiovascular disease.      The objective of this trial is to evaluate the clinical and metabolic efficacy of metformin     plus life style modifications in women with polycystic ovary syndrome compared with life     style modifications and placebo   "
216058|NCT00679692|"     BACKGROUND The insulin-like growth factor system (IGFs) plays an important role in cell     growth and differentiation. Nevertheless, the roles played by insulin-like growth factor-1     (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) and human growth hormone     (HGH) in the progression of chronic liver disease remain to be elucidated and investigated.      METHODS The subjects in the present study included 60 healthy controls, 30 hepatitis     patients, 60 liver cirrhosis patients and 60 untreated hepatocellular carcinoma patients.     Blood was drawn by venipuncture into Venoject tubes. To find the possible correlations     between liver damage and IGFs, serum IGF-1, GH, IGFBP-3 concentration and related biochemical     parameters were measured. We used immunoradiometric assay to determine the levels of IGF-1,     HGH and IGFBP-3 in serum.   "
216059|NCT00679705|"     This trial will consist of two parts:      A pilot study in a three-way cross over trial to determine the highest well tolerated dose of     Ritodrine (Pre-Par®), the impact of Atosiban (Tractocile®) on the hemodynamics and hence the     design of the final study.      The final study is planned as a three-way crossover trial to investigate and compare the     cardiovascular effects of Ritodrine, Atosiban and placebo to relate those effects to the     pharmacokinetics of Ritodrine and Atosiban (PK/PD modelling).   "
216060|NCT00679718|"     To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in     patients with moderate to severe dry eye disease.   "
216061|NCT00679731|"     This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in     subjects with moderate to severe plaque psoriasis.   "
216086|NCT00680056|"     The primary objective is to comparatively evaluate the isolated effects of a long-acting     beta2-adrenergic (formoterol fumarate 12µg b.i.d. via Aeroliser) and combined with a     long-acting anti-cholinergic (tiotropium bromide 18µg o.d via Handihaler) on breathlessness,     dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic     obstructive pulmonary disease. The study hypothesis is that combining long acting     bronchodilators with different action mechanisms would promote synergistic effects on     clinical outcomes.   "
216102|NCT00680277|"     The goal of this protocol is to determine the vitamin A value (equivalence) of spirulina. The     investigation will use intrinsically deuterium labeled spirulina and an isotope vitamin A     reference dose, 13C10- retinyl acetate (13C10 RAc), in males (n=20). Up to 45 blood samples     (10 ml/sample) will be collected from each subject over a two-month period to evaluate the     bioavailability and bioconversion of spirulina ß-carotene to vitamin A.   "
216062|NCT00679744|"     Adult Tay-Sachs disease and Sandhoff diseases are caused by deficiency of an enzyme called     β-hexosaminidase A, or Hex A in short. This enzyme is located in a particular cellular     component, called lysosomes, inside the brain cells. The reason that Hex A of patients with     Adult Tay-Sachs disease or Sandhoff disease is deficient is because this enzyme had gone     through mutation, resulting in it not working very well. In healthy people, Hex A efficiently     breaks down GM2-ganglioside, which is a by-product from cells of our body. However, patients     with Adult Tay-Sachs disease or Sandhoff disease cannot efficiently break down     GM2-ganglioside in the body. Therefore, these patients have high levels of this by-product in     the brain cells, which causes the brain to be unable to function normally.      There is a drug called Pyrimethamine. This drug is used by doctors to treat specific types of     infections called malaria and toxoplasmosis. Our laboratory test tube studies have shown that     Pyrimethamine can help the Hex A enzyme to function in a normal manner. If Hex A can function     normally in presence of Pyrimethamine, this drug should be able restore the brain malfunction     of these patients since Hex A can now efficiently break down GM2-ganglioside with     Pyrimethamine treatment.      Although results from laboratory test tube studies are promising and Pyrimethamine should     theoretically restore brain function of these patients, we do not know if Pyrimethamine is     safe or if it would actually work in patients. This study is the first study (a Phase I     study) of testing Pyrimethamine to treat Adult Tay-Sachs and Sandhoff diseases. The objective     of this study is to see if Pyrimethamine is safe in these patients and to see if it can     restore the brain function of these patients.   "
216063|NCT00679757|"     This study is looking at the prevalence of sleep apnea in a wound center population. It uses     both screening surveys and take home devices. Some measures of wound healing ability are     being looked at as well.   "
216068|NCT00679822|"     The objective of this protocol is the evaluation of our clinical screening program for sleep     disorders in patients with heart failure.      These patients have very high prevalence of Sleep Disordered Breathing (SDB), including     central and obstructive sleep apnea. There is also strong evidence that SDB, if unrecognized     and untreated, will worsen heart failure and may leads to serious complications. Effective     treatment of SDB results in improvement in heart failure and functional status. So far there     are no guidelines in the area of screening in this patient population. The only test that     would reliably rule out or confirm SDB is the polysomnography (PSG) this test is expensive     and technically demanding. With the current approach to diagnosis and treatment of SDB, it     routinely takes up to 5-6 months between the emergence of clinical suspicion of SDB and the     initiation of appropriate treatment with CPAP. This delay and cost of this traditional     approach, is a significant obstacle to providing highly needed care to this very vulnerable     population.      In OSU we have a state of the art Heart Failure Program and a Sleep Heart program that was     created to develop an approach to prompt diagnosis and treatment of SDB in our heart failure     patients. We designed an algorithm that employs validated questionnaires and FDA approved     devices. We need, however to validate our algorithm against the gold standard: the PSG.     Furthermore, we need to analyze the prevalence and risk factors of each sleep disorder in     light of the recent changes in the management of heart failure, which may have influenced the     risk factors and prevalence as we knew them. This protocol includes a combination of     clinically indicated procedures, and others that are repeated for validation purposes. The     accumulation and analysis of data is also done for research purposes.   "
216069|NCT00679835|"     This is a research study designed to look at the pharmacokinetics (distribution, breakdown,     and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years     who have infections that are caused by a specific group of bacteria (called Gram-positive     bacteria).   "
216070|NCT00679848|"     The purpose of this study is to evaluate the safety, technical feasibility, and initial     effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR     performed using the Bard RESTORe Suturing System   "
216071|NCT00679861|"     Primary care physicians can play an important role in reducing tobacco smoking in the     population. The general practice is a suitable setting for implementing proactive smoking     interventions, because a large proportion of the population can be regularly reached in a     favorable psychological state. Further, a trustful interpersonal relationship between the     practitioners and their patients is supposed to increase the susceptibility to preventive     measures. However, currently general practitioners are not capitalizing this advantage     although evidence based treatments are available, which are effective and cost-effective.     Outreach programs combining educational and practice-based measures have been found to be     effective in engaging practitioners in screening and in giving advice. Computer expert-system     and brief counseling interventions, which are based on the Transtheo-retical Model of     behavior change (TTM), are promising approaches for the entire population of practitioners     and smoking patients. For large scale implementation, data are needed about the degree of     integration in every day routine clinical practice that could be achieved by implementing     such interventions. Objectives: Evaluating different strategies for the implementation of     proactive smoking interventions in general practices. Methods: In a randomized controlled     trial, 150 randomly selected general practices of a defined German region will be included.     The procedure comprises the implementation of 1) an on-site computer expert-system     intervention, 2) a counseling intervention provided by the practitioner, or 3) the computer     expert-system plus the counseling intervention. During an implementation phase of one month,     two on site training sessions and support by phone will be provided. Routine use of the     interventions will be monitored for the following 6 months. Main outcome measures are the     number and rate of identified and treated smokers. A follow-up assessment will be realized 12     months after practice attendance to determine the smoking status of the treated smokers.   "
216101|NCT00680264|"     The purpose of this study is to determine the radiographic and clinical outcomes of Scoliosis     surgical treatment in patients with Cerebral Palsy.   "
216072|NCT00679874|"     Consecutive patients with a first diagnosis of breast cancer will be identified at the Tom     Baker Cancer Centre (TBCC) and included into the study, if they are going to receive     chemotherapy with anthracyclines and / or Trastuzumab and do not have contra-indications for     the CMR study. Besides the usual clinical care for these patients (e.g. blood samples before     each cycle of chemotherapy; MUGA scans to follow cardiac size and function), the patients     will undergo serial contrast-enhanced CMR studies (before, during and 9-12 months after     completion of the chemotherapy); patients will be seen at an outpatient clinic in the Dept.     of Cardiac Sciences / Heart Function Clinic for a clinical assessment (including ECG,     additional blood test like Troponin-T, BNP, 6-minute-walk-test) and recommendations will be     made to medical treatment in patients with evidence for heart failure.      Time points for the CMR and clinic assessments will be co-coordinated with regularly     scheduled test by the TBCC to avoid unnecessary burden for the patients. The oncologists at     the TBCC will be blinded to the results of the CMR studies and to laboratory results, unless     the participating cardiologists identify a clinical need for communication.      Standardized CMR protocols will be employed and all interpretations will be blinded to the     time course of the chemotherapy and cardiotoxic side effects.      We will test the hypothesis, whether CMR can be useful in patients with potentially     cardiotoxic chemotherapy to:        -  Identify patients at risk for the development of grade 2-4 cardiotoxic side effects as          classified by the NCI guidelines (common toxicity criteria, 2001, 1-12)        -  Identify imaging parameters to predict early or late Cardiotoxicity        -  Provide additional clinical information to optimize medical treatment for heart failure   "
216073|NCT00679887|"     The purpose of this study is to find the efficacy of treating the trigger points located     around the shoulder in patients suffering from chronic shoulder pain.   "
216074|NCT00679900|"     The primary objective is to compare the potential for next-day residual effects of     eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning     using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic     primary insomnia and sleep maintenance difficulties.      The secondary objectives are to compare the clinical safety of both products, including the     potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to     compare the efficacy of both products on subjective sleep parameters and to compare the     effects of both products on patient's daytime functioning.   "
216075|NCT00679913|"     This study was designed to test the hypothesis that more extensive nodal and soft-tissue     clearance in patients with adenocarcinoma of the head of the pancreas would improve survival     without an increase in morbidity and mortality.   "
216076|NCT00679926|"     Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r,     800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50     copies/ml in antiretroviral naïve patients through 48 weeks of therapy.   "
216078|NCT00679952|"     Pancreaticojejunal anastomosis leakage is a major complication after pancreatoduodenectomy     and various technical methods have been examined to improve the situation.However, none of     methods have been successful at improving results according to the findings of prospective     randomized studies. We propose that active drainage of pancreatic juice using suction     drainage might maximize the advantage of a stent and finally reduce pancreaticojejunal     anastomosis leakage.   "
216079|NCT00679965|"     The purpose of the study is to determine the safety and efficacy of 2.5%, 5.0%, and 7.5%     AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual     onychomycosis of the great target toenail.   "
216080|NCT00679978|"     Osteoporotic vertebral fracture (VF) and osteonecrosis of the femoral head (OFH) are major     concerns in patients with systemic rheumatic diseases treated with high-dose glucocorticoids     (GCs). The investigators examined and compared the incidence and risk factors of VF with     those of OFH in patients who had recently received high-dose GC therapy to clarify the     relationship between these two complications.   "
216081|NCT00679991|"     PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the     outside surface of the blood vessel. The purpose of this study is to determine if PRT-201,     when applied to a limited segment of blood vessel immediately after surgery to create an     arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow     through the AVF.   "
216082|NCT00680004|"     This pilot study aims to quantitatively characterize the stresses and forces on an implanted     endograft during the cardiac cycle in patients scheduled for standard endograft follow-up.     The developed techniques will be applied in future studies for characterizing and comparing     the currently commercially available endografts so as to gain insight into the mechanisms     underlying potential endograft failure. In addition, to assist in developing endografts with     long-term durability and functioning characteristics for the benefit of the patient   "
216083|NCT00680017|"     The objective of this study is to evaluate the safety and efficacy of the combination of     ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.   "
216084|NCT00680030|"     In the current study we plan to evaluate the effects of the conversion from gastric banding     to gastric bypass on esophageal function using combined monitoring. The primary aim of the     current study is to evaluate esophageal function before and 3-months after the conversion     from gastric banding to gastric bypass. A second objective is to evaluate the severity of     symptoms, esophageal dysmotilities, endoscopic abnormalities and bolus retention found in     patients referred for conversion from gastric banding to gastric bypass. Our hypothesis is     that esophageal motility disorders associated with gastric banding are reversed by conversion     to gastric bypass.   "
216085|NCT00680043|"     The purpose of this study is to evaluate the safety and efficacy of peginesatide for the     treatment of anemia in participants with chronic kidney disease who are on dialysis and are     not taking any treatment to increase their red blood cell production.   "
216103|NCT00680290|"     The purpose of this study is to 1) assess the effect of routine exercise on the quality of     life of patients with permanent atrial fibrillation, and 2) assess the effect of exercise on     cardio-hemodynamics in patients with atrial fibrillation.   "
216087|NCT00680069|"     The purpose of this research study is to study the safety and effectiveness of vaccinating     individuals who have previously received an avian influenza vaccine derived from one type of     H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second     reason for this study is to compare responses in people who have received two different but     similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the     H5N1 vaccine used in this study. The information obtained may provide important information     into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy     adult volunteers, ages 19 and older, in the United States. Study procedures include: physical     exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of     vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side     effects. Study participation will be approximately 7 months.   "
216088|NCT00680082|"     To describe the way statins are used in France in primary care, that is to determine patients     profile (particularly CV risk factors), to determine the way statins are initiated by general     practitioners, to evaluate aftercare and to assess patients treated by rosuvastatin   "
216089|NCT00680095|"     The purpose of this study is to determine the cumulative irritation potential of the products     listed by the Sponsor.   "
216090|NCT00680108|"     The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic     Solution when applied topically as eyedrops in patients with mild to moderate dry eye     disease.   "
216091|NCT00680121|"     B1AS tests the hypothesis that increased vitamin B1 (thiamine) intake can repair brain     systems damaged by alcohol and help people with alcohol problems control their alcohol use. A     strong, man-made form of thiamine (Benfotiamine) is used to increase blood thiamine to much     higher levels than can be achieved using normal vitamin supplements. Drinking patterns are     examined over 6 months of continued supplement use. Men and women with a recent history of     alcohol problems are eligible to participate.   "
216092|NCT00680134|"     The purpose of the study is to determine the safety and efficacy of 1% and 5% AN2690     solutions in the treatment of distal, subungual onychomycosis of the great toenail.   "
216093|NCT00680147|"     This will enroll 300 mothers of teenage girls and boys to identify barriers to HPV     vaccination among low-income, African-American teens.   "
216094|NCT00680160|"     The purpose of the study is to determine the absorption, systemic pharmacokinetics and     accumulation in the nail of AN2690 during a 28 day period of daily application of a 7.5%     solution of AN2690 to all 10 toenails of up to 25 otherwise healthy adult patients with     onychomycosis.   "
216095|NCT00680173|"     Our previous collaborative studies has developed a molecular diagnosis tool, which is     characterized with a prediction model consisting single nucleotide polymorphisms (SNPs), for     assessing the efficacy of interferon combined therapy for chronic hepatitis C (CHC) patients     prior to treatment.      Aims of this project:        1. To analyze and validate the gene expression profiling dependent of treatment response to          peg-interferon-α plus ribavirin combination therapy in CHC genotype-1 patients.        2. To select the candidate genes and establish a monitoring model assessing the efficacy of          interferon treatment.   "
216096|NCT00680186|"     The general aim of this study is to determine the comparative safety and efficacy of     dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN)     to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute     symptomatic VTE.      The primary objective is to investigate the efficacy of dabigatran compared to warfarin     during the 6 month treatment period. The investigation of other selected efficacy aspects and     safety are regarded as secondary objective of this trial.   "
216097|NCT00680199|"     Chronic insomnia is thought to occur as a result of hyperarousal. While there is a wealth of     data to support this position, there is a lack of research to define how hyperarousal     interferes with sleep initiation, maintenance, and the perception of sleep quality and     quantity. We propose to use Event-related Potential (ERP) techniques to evaluate information     processing at sleep onset and during sleep. ERP measures of information processing have been     well established in good sleepers; they have not been, however, applied to the problem of     insomnia. The goal of the project is to examine the premise that the occurrence and severity     of insomnia is fundamentally related to a neurobiologic preparedness to attend to and     identify environmental stimuli. Following an extensive screening, patients with insomnia     and good sleepers will participate in two experimental conditions, requiring that they spend     four nights in the sleep laboratory over a two week period. ERP data will be gathered prior     to, following, and during sleep.      The ultimate objectives for this line of research are to determine 1) if insomnia is     associated with a failure to inhibit information processing at sleep onset and/or during     sleep, 2) if the failure to inhibit information processing at sleep onset and/or during sleep     is associated with the occurrence and/or severity of insomnia symptoms, 3) what brain regions     are functioning differently so as to give rise to information processing abnormalities, and     4) the extent to which pharmacologic and/or Cognitive Behavioral treatment for insomnia     alters information processing abnormalities and/or the associated brain activity.   "
216098|NCT00680212|"     Our objectives will be to test the following hypotheses and to make the following     determinations: (1) The absorption and bio-conversion of provitamin A carotenes taken by     children are different between spinach, Golden Rice, and ß-C in oil capsules. (2) The     absorption of provitamin A carotenes and their bioconversion to vitamin A are different in     children with or without adequate vitamin A nutrition. (3) To define the vitamin A     equivalence(s) of dietary spinach, Golden Rice, and a ß-C in oil dose by using an isotope     reference method in children with or without adequate vitamin A nutrition and to compare     those values with values derived from model based compartmental analysis. (4) To determine     the number and time of blood samples needed for future studies in various field settings on     the retinol equivalence of a large number of plant sources.   "
216099|NCT00680225|"     To report preliminary results on safety and tolerability of intravitreal injection of     Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green     (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.   "
216100|NCT00680238|"     Objective: To compare pregnancy rates and implantation rates when embryos are selected based     on a single Day 3 (D.3) score vs. a GES score plus sHLA-G expression.   "
216105|NCT00680316|"     This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed     to evaluate the effect of Pulmozyme on pulmonary function, health-related quality of life     (HRQOL), and respiratory symptoms in 3- to 5-year-old children with cystic fibrosis (CF).     Approximately 40 patients were planned to be enrolled in this study. However, only 3 patients     were eligible for random allocation and received treatment: 1 patient in the Pulmozyme group     and 2 patients in the placebo group. All 3 patients completed the study assessments but did     not have usable pulmonary function test (PFT) data.   "
216106|NCT00680329|"     The purpose of this study is to evaluate adherence to DuoTrav® when reinforced by the use of     the Travalert™ Dosing Aid.   "
216107|NCT00680342|"     Silymarin (Legalon), also known as milk thistle, is an alternative medicine commonly found in     health food and vitamin stores. People with liver disease sometimes use silymarin because it     is thought to have liver protecting effects; however, this benefit has not been proven. The     purpose of this research study is to determine the effectiveness of silymarin and assess the     safety of different silymarin doses in patients with varying severity of liver disease     compared to a placebo (lactose pill).      Eligible subjects will be randomized to treatment with placebo or one of two dosages of     Legalon® 420 mg or 700 mg administered orally thrice daily. Investigators and subjects will     be masked to treatment assignment. The study design includes a screening period during which     patients will undergo full medical evaluation to verify protocol eligibility and a treatment     period of 24 weeks during which time clinic visits and laboratory studies will be performed     every 2-4 weeks to monitor for safety and efficacy of therapy. Subjects will continue to be     followed for an additional 12 weeks after the completion of study medication to monitor for     adverse events and investigate post-treatment outcomes. Participation in this research study     requires the subject to travel to the clinic for at least 10 visits so recruitment will be     limited to a geographically restricted area around participating clinical centers.   "
216108|NCT00680355|"     This investigation protocol uses an isotope reference method to evaluate bioavailability of     ß-C in rice and its bioconversion to vitamin A.      A well-nourished population will be fed hydroponically grown Golden Rice containing ~ 1 mg of     β-carotene at day 8 after a reference dose of vitamin A at day 1. The blood samples will be     collected up to 33 days after the doses. The absorption kinetics will be determined by     tracking both vitamin A and β-carotene in human serum. Blood responses to Golden Rice     β-carotene will be determined and evaluated. The vitamin A value of Golden Rice can thus be     quantitatively determined.   "
216109|NCT00680368|"     OBJECTIVES: To develop, assess feasibility, and test the validity of the Resident Supervision     Index (RSI), a survey tool for medical residents designed to measure quantitatively the level     of supervision the resident received while caring for an outpatient during a patient care     encounter.      RESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index     (Index) applied to outpatient care encounters for content validity, test-retest reliability,     and construct validity.   "
216118|NCT00680485|"     This study will evaluate the safety, tolerability and exposure of repeat escalating oral     doses, a loading dose/maintenance dose regimen of GSK580416 and when co administered with     ketoconazole, a PGP/CYP3A4 inhibitor.   "
216110|NCT00680381|"     The purpose of this study is to test different treatments to reduce relapse for drug-abusing     adolescents who have completed family therapy. Adolescents receive 12 weeks of family     therapy, designed to strengthen family relationships and develop skills for helping the     adolescent avoid drug use. Then they are randomly assigned to receive one of three eight-week     follow-up treatments: phone calls from a project therapist, group therapy, or a customized     schedule of therapist visits with the adolescent, the adolescent's family and teachers,     coaches, probation officers and others who can help the adolescent reach or maintain     abstinence. Families are assessed using questionnaires and interviews before, during and     after treatment, to provide information about family functioning, the adolescent's drug use,     the adolescent's peers and other factors that may contribute to treatment success or failure.     Adolescents also provide urine specimens for drug screening at assessment visits. Study     investigators expect the study will show that a functional family environment and insulating     adolescents from the influence of peers who use drugs will help prevent relapse for     adolescents who have received family therapy.   "
216111|NCT00680394|"     A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and     acceptability of two medical abortion regimens up to 63 days' LMP. The first regimen will     include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second     regimen will include two 800 mcg doses of buccal misoprostol. We hypthesize that both methods     work well, but that the mifepristone regimen will have an efficacy rate of approximately 95%,     and misoprostol alone will be closer to 90%. We will consider a greater than 5% difference to     be clinically meaningful.   "
216112|NCT00680407|"     Silymarin, also known as milk thistle, is an alternative medicine commonly found in health     food and vitamin stores. People with liver disease sometimes use silymarin because it is     thought to have liver protecting effects; however, this benefit has not been proven. The     purpose of this research study is to determine the effectiveness of silymarin and assess the     safety of different silymarin doses in patients with varying severity of liver disease     compared to a placebo (lactose pill).      Following a screening visit, patients with histologically confirmed NASH will be randomized     to either placebo or one of two active treatment groups of silymarin (Legalon®). One active     treatment group will receive 420 mg, each dose given three times daily, the other active     treatment group will receive 700 mg, each dose given three times daily. Patients will be     treated for 48-50 weeks. Participation in this research study requires the patient to travel     to the clinic for at least 11 visits so recruitment will be limited to a geographically     restricted area around participating clinical centers. Liver biopsy must be performed up to     12 months prior to, and immediately after, the treatment phase.   "
216124|NCT00680563|"     This single arm study will assess the efficacy and safety of subcutaneous Mircera for the     correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who     are not currently treated with ESA. Eligible patients will receive monthly subcutaneous     injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study     treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
216162|NCT00681083|"     Patients who have Obstructive Sleep Apnea (OSA) may have different Continuous Positive Airway     Pressure (CPAP)when titrated with different levels of humidification. It is hypothesised that     patients with ThermoSmart® technology (heated breathing tube technology) will have lower     titrated pressures than those who are titrated using conventional humidification (non heated     breathing tube).   "
216113|NCT00680420|"     Pancreas cancer and precancerous cysts can be difficult to diagnose. Sometimes biopsies do     not show cancer when cancer is actually present. We hypothesize that genetic differences     exist in tissue that is malignant compared to nonmalignant. When patients present with a     pancreas mass or cyst, we biopsy it by fine-needle aspiration during upper endoscopy with     ultrasound guidance. We would like to use tissue obtained via endoscopic ultrasound guided     fine needle aspiration to perform DNA microarray analysis, and compare the differences in     gene expression level in the benign tissue compared to cancerous tissue in order to improve     our diagnostic capabilities. DNA microarray measures gene expression level rather than     germline mutations. The true diagnosis will be based on cytology, surgical pathology, or     clinical followup. The performance of the microarray test as a diagnostic test will be     compared to the performance of cytology.   "
216114|NCT00680433|"     Research into the mechanisms underlying memory impairment in ECT suggests that its     development may be prevented by the administration of certain medications at the time of ECT     treatment. For example there are reasons to believe that ketamine, also used as an     anaesthetic agent, may have such protective properties.      In this clinical study patients undergoing a course of ECT will be offered the opportunity to     receive a small dose of ketamine (or a placebo) as part of their anaesthetic at the time of     ECT treatment. Mood changes and any memory changes will be evaluated to see if the subjects     who received ketamine had less memory side effects than those who did not, while still     improving their depression.   "
216115|NCT00680446|"     The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in     patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement     therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.   "
216116|NCT00680459|"     Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections      Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct     therapy with antibiotics to treat central venous line infections      Study Design Randomized Controlled Trial      Study Protocol Only those patients meeting all inclusion criteria and no exclusion criteria     will be eligible to participate in this study. Once identified, signed informed consent will     be obtained from the patient's guardian and the patient himself/herself depending on age.     Patients will be randomized into 2 groups: Group 1 - those patients who will receive ethanol     lock therapy and Group 2- those patients who will receive placebo therapy in the form of a     heparin lock solution.      Outcome Measures Treatment success as defined by-        -  Clearance of the infection as documented by negative blood cultures on day 6 (one day          after completed of lock treatment)        -  Preservation of the line at 30 days post treatment (day 35 of the study), this will be          documented by a chart review in CIS and telephone interview to ensure no further growth          from blood cultures or infections      Treatment failure as defined by-        -  Clinical worsening during treatment        -  Removal of the line due to persistent infection or sepsis        -  Recurrence of infection with the same pathogen within 30 days   "
216119|NCT00680498|"     This is a one-year, randomized, single-center open-label pilot study of the safety and     efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to     either combination treatment, or ranibizumab monotherapy (control group).      The combination treatment group will receive ranibizumab, followed 1 week later by     verteporfin PDT. Additional treatments will be based on evidence of active disease     (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed     monthly, and repeat PDT will be allowed every 3 months.      The control group will receive standard-of-care ranibizumab monotherapy according to the     protocol currently followed by most retinal specialists. Ranibizumab injections will be given     at baseline and months one and two. Additional injections will be given at each monthly visit     at which there is evidence of active disease by visual acuity, OCT and FA criteria.   "
216120|NCT00680511|"     The AIMS study compares a methamphetamine-specific treatment intervention to a     treatment-as-usual Functional Family Therapy (FFT) approach for adolescents ages 15 to 19.     Adolescents are assigned to one of two treatment conditions: (1) 16 weeks of FFT designed to     strengthen family relationships and develop skills for helping the adolescent avoid drug use;     or (2) 16 weeks of a combination of FFT and a methamphetamine-specific intervention involving     group and individual therapy sessions; Families are assessed using questionnaires and     interviews, and adolescents participate in neuropsychological testing, before, during, and     after treatment to provide information about family functioning, the adolescent's drug use,     the adolescent's peers, and other factors that may contribute to treatment success.     Adolescents also provide urine specimens for drug screening at assessment visits. Through a     partnership with Oregon Health and Science University (OHSU), adolescents will participate in     functional magnetic resonance imaging appointments at the hospital to examine regional brain     blood flow during tasks designed to measure impulsivity and risk-taking behaviors. As a     treatment development grant, study investigators will study adolescents' acceptance of and     response to the newly developed methamphetamine-specific treatment approach.   "
216121|NCT00680524|"     Objective: OEF/OIF (Operation Enduring Freedom and Operation Iraqi Freedom) veterans are     presenting with high rates of PTSD. Translating Initiatives for Depression into Effective     Solutions (TIDES) is a model of phone-based care being implemented nationally as a model to     address those patients suffering from depression, PTSD, or alcohol use disorders. However,     evidence-based treatments do not yet exist for phone-based management of OEF/OIF veterans who     suffer from PTSD.      Research Plan:      This is an open trial to assess feasibility of augmenting standard treatment of PTSD with     TIDES based telephone-based nurse care management.   "
216122|NCT00680537|"     This is a clinical research study to determine if a prescribed physical therapy intervention     after subcutaneous implantation of an implanted cardioverter-defibrillator (ICD) or pacemaker     reduces the incidence of rotator cuff tendonitis when compared to usual post procedural care.   "
216123|NCT00680550|"     To describe the clinical indications for Reveal XT in diagnosis and continuous monitoring of     arrhythmia and to explore the clinical applications and outcome of arrhythmia monitoring on     patient care.   "
216125|NCT00680576|"     The purpose of this study is to find out more about how to provide effective further     treatment for adolescents who have received six weeks of group therapy for substance-use     problems and continue to use drugs. Treatments used in the study include a group therapy     (MET/CBT), an individual therapy (CBT), and a family therapy (FFT). The study will look at     whether abstinence or a very low level of use is a better guide for deciding whether further     treatment is needed, how well different combinations of treatment work to reduce substance     use, and whether it is possible to predict in advance which adolescents will respond best to     which types of treatment. Study investigators expect that a treatment strategy using what is     learned about these issues in the first half of the project to develop an adaptive     treatment model will work better than a fixed treatment to reduce adolescent substance use.   "
216126|NCT00680589|"     The goal of this study is to find out about the safety of injecting the gene (DNA) for mouse     TYRP2 in patients with melanoma. DNA is a material that contains the information needed to     produce many substances in the body. TYRP2 is a substance found in melanoma cells that helps     to produce their black color. The DNA used in this study is the gene for mouse TYRP2.      The gene is introduced into bacteria, which are grown in large quantities. The DNA vaccine is     then made from bacteria that is inactive.      We would like to see if we can immunize patients against TYRP2 by injecting mouse TYRP2 DNA.     We will also follow the patients closely to see if there are any side effects. Mouse TYRP2     DNA is very similar to human TYRP2 DNA. We believe, based on lab experiments, that injection     of mouse TYRP2 DNA could result in the production of immune substances (antibodies and T     cells) that recognize melanoma cells. Antibodies are substances produced by your immune     system to defend your body against bacteria and viruses. T cells are a type of white blood     cell that can also fight infections. The small differences between mouse and human TYRP2 may     allow your immune system to make the antibodies and T cells against melanoma. There is no     evidence yet that injection of TYRP2 DNA results in any clinical benefit in patients.   "
216127|NCT00680602|"     First line treatments fo Obsessive Compulsive Disorder (OCD) are Selective Serotonin     Recapture Inhibitors (SSRIs) and Cognitive Behaviour Therapy (CBT) including exposure with     response prevention. The aim of the present study is to evaluate the clinical efficacy of     GCBT and SSRIs for OCD patients. Other clinical trials have compared these treatments, but     with OCD patients without any other psychiatric disorder. In this study patients with current     age between 18 and 65 years, with YBOCS score of at least 16 and psychiatric comorbidities     will be not excluded. Exclusion criteria will be: OCD secondary to brain trauma, stroke or     malformation; current abuse of alcohol or other psychoactive substance, current presence of     psychotic symptoms, suicidal risk, psychiatric or clinical comorbidity that might get worse     with the medications used in the trial. So, the present study investigates the efficacy of     these treatments for a heterogeneous OCD population, trying to identify if the usual     treatments are efficient when applied in the public health system that treat not just     patients with only OCD diagnosis. Patients will be randomized for GCBT and SSRI, and after     treatment will be evaluated by researchers blind to the treatment received.   "
216128|NCT00680615|"     To compare the efficacy of a targeted, tailored, and highly interactive smokeless tobacco     cessation website to a website with more static information that is similar to websites that     can be found through a typical Internet search.   "
216130|NCT00680641|"     To determine the effects of 2 months therapy with simvastatin 40mg once per day compared to     placebo in a double-blind placebo-controlled study of patients with COPD.   "
216131|NCT00680654|"     This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic     effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of     sildenafil 20 mg.   "
216132|NCT00680667|"     RATIONALE: Coriolus versicolor mushroom extract may slow the growth of cancer cells and may     be an effective treatment for breast cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of coriolus versicolor     extract in treating women with stage I, stage II, or stage III breast cancer who have     finished radiation therapy.   "
216133|NCT00680680|"     To determine whether the addition of a dual Five Alpha Reductase Inhitor (Dutasteride) will     alleviate urinary retention secondary to BPH in who have failed a voiding trial without a     catheter. Following treatment with an Alpha Blocker alone.   "
216134|NCT00680693|"     Irritable bowel syndrome (IBS) is a common and disabling functional disorder characterized by     significant abdominal discomfort and disturbed defecation. It affects over 10% of U.S. adults     (14% women, 8% men), resulting in major disability, impaired quality of life, and a     significant health-care burden. Conventional management of IBS is only partially effective in     some patients and includes use of medications, behavioral modification, dietary approaches,     and lifestyle changes such as exercise and stress reduction. Although behavioral treatments     such as cognitive behavioral therapy and hypnosis have been among the most effective     treatments, they are costly to deliver.      Mindfulness meditation, a complementary/alternative medicine (CAM) therapy taught in groups,     is a unique self-regulatory, mind-body approach in which practitioners learn to attend to     present-moment experiences, letting go of fixation on negative emotions and thoughts of past     and future. It has been found to be effective in reducing chronic pain and stress and in     ameliorating disorders with similarities to IBS, including fibromyalgia, headache, and     depression.      The overall goals of this exploratory, pilot study of women with IBS are to compare     mindfulness meditation training to a patient support group (a previously validated control     condition) in a small, randomized controlled clinical trial, in order to assess the     feasibility of a larger, definitive trial. Specific aims are to evaluate primary and     secondary outcome measures, to assess expectancy of benefit and scales measuring mindfulness     (process measures), and to identify barriers to conducting such a trial in our setting. Sixty     women meeting Rome II diagnostic criteria for IBS will be randomly assigned to one of two     treatments - mindfulness meditation training or a support group - and will undergo 8 weekly     group sessions plus a single day-long session. The primary outcome measure is improvement on     the validated Irritable Bowel Symptom Severity Scale from pretreatment to the end of     treatment, with follow-up at 3, 6, and 12 months. Additional variables address alternative     endpoints (e.g., Adequate Relief of IBS symptoms, disease specific quality of life) and     mechanism of treatment effects (e.g., coping scales, psychological symptoms, Visceral     Sensitivity Scale). The multidisciplinary research team includes physicians, psychologists,     and educators.   "
216145|NCT00680849|"     This study is a 5-year continuation of The Mediterranean Lifestyle Program. The purpose of     this follow-up study is to determine the long-term effects from prior participation in an     intervention promoting healthful eating, exercise, quitting smoking, stress management, and     social support. Participants are post-menopausal women with type 2 diabetes.   "
216146|NCT00680862|"     Qualitative assessment of implementing routine HIV rapid testing in primary care clinics     within VA   "
216135|NCT00680706|"     Heart failure remains an increasing cause of morbidity and mortality in the United States     even in the face of recent advances in the treatment of cardiovascular disease. There is an     urgent need to reevaluate the treatment of heart failure. Shifting substrate utilization used     in energy metabolism from fatty acids to glucose is beneficial to the heart presumably by     increasing the efficiency of ATP production. Several new drugs for the treatment of cardiac     ischemia work by this mechanism. There is increasing evidence that patients with heart     failure may also benefit by the same type of intervention. Patients with heart failure are     known to have low serum thiamine levels because of poor dietary intake and increased urinary     excretion. Inadequate thiamine will deleteriously shift substrate utilization from glucose to     fatty acids.      We hypothesize that thiamine supplementation will be beneficial for patients with heart     failure by increasing glucose and decreasing fatty acid utilization. This will be initially     tested in a pilot double-blinded placebo controlled study of thiamine supplementation in     diabetic and non-diabetic patients presenting to the emergency department with acute     decompensated heart failure.   "
216136|NCT00680719|"     This project involves two studies focusing on the engagement and treatment of adolescents     diagnosed with substance use disorders. Study 1 will evaluate a promising parent-based     engagement intervention, Community Reinforcement Training, designed to facilitate the entry     of resistant drug-abusing adolescents in treatment. The approach will be compared with an     Engagement As Usual intervention condition. Study 2 involves a controlled clinical trial     evaluating the efficacy of an HIV/AIDS prevention intervention embedded in family-based drug     abuse treatment for reducing HIV/AIDS risk behaviors and substance use. Adolescents who are     successfully engaged in treatment through Study 1 will be randomly assigned to receive either     family therapy alone or family therapy with the integrated HIV/AIDS prevention intervention.     Both studies are being conducted in Portland, Oregon.   "
216137|NCT00680732|"     Our objective was to investigate the importance of malaria infection/disease during pregnancy     and more particularly during the first trimester; we also looked at the maternal-foetal     interactions and their influence on the subsequent child's response to malaria infections     during the first year of life. This study was carried out !in the same population recruited     for the IUGR study (NCT00642408).   "
216138|NCT00680745|"     This study is being carried out to see if dapagliflozin in addition to glimepiride     (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared     to glimepiride alone.   "
216139|NCT00680758|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving more than one drug (combination chemotherapy) together with     everolimus may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of cisplatin,     paclitaxel, and everolimus when given together for the treatment of patients with metastatic     breast cancer.   "
216173|NCT00681226|"     Leg pain caused by peripheral arterial disease (PAD) can severely impede walking ability. Our     preliminary findings indicate that the drug ramipril is much more effective in improving     walking ability than current therapies. To be accepted as a new treatment for PAD these     findings require validation in a much larger clinical trial.We propose to examine the effects     of ramipril therapy for 6 months in a randomized, controlled trial of patients with PAD. If     positive, this study will identify ramipril as a potential new therapy for PAD.   "
216140|NCT00680771|"     Chronic insomnia affects approximately 8-9% of the population. The prevalence of this     disorder rises dramatically across the lifespan, especially so in women. When it is chronic,     insomnia is associated with increased fatigue, cognitive impairment, mood disturbance,     physical complaints, diminished quality of life and increased health care consumption. There     is also more limited evidence (based on epidemiologic studies or experimental studies in     healthy subjects) that insomnia and/or sleep loss may be a risk factor for hypertension     and/or cardiovascular disease and increased mortality.      Despite its prevalence and consequences, the pathophysiology of insomnia and, specifically,     the pathway by which morbidity risk is conferred, has been relatively unstudied. With respect     to medical illness in particular, insomnia may confer risk in several ways, including: 1) an     inherent compromise in the restorative/conservative function of sleep, 2) the deleterious     effects of hyperarousal and/or HPA axis abnormalities on end organ integrity and function,     and/or 3) diminished immunocompetence. This study focuses on the last of these possibilities,     the relationship between immune function and sleep.      The study compares immune response to a vaccine challenge in two groups: good sleepers and     patients with chronic insomnia. The primary study hypothesis is that the insomnia group will     have a decreased rate of adaptive immune response to the vaccine challenge than that of the     good sleeper group.   "
216141|NCT00680784|"     The objective of this study is to demonstrate the multiple-dose efficacy and safety of     HKT-500 for the treatment of ankle sprain.   "
216142|NCT00680797|"     The goal of this research study is to study the effect of testosterone or estrogen on blood     sugar control and fat metabolism. Changes in hormone levels with age may affect risk factors     for heart disease such as diabetes. Diabetes is a glandular condition associated with lack of     the hormone insulin or an insensitivity to it resulting in problems with blood sugar control     and fat metabolism. The effect of commonly used hormonal supplements such as testosterone by     older adults on insulin and body composition is not well understood. In this study, the role     of testosterone and estrogen on your ability to control blood sugar and your body composition     will be assessed.      The investigators plan to study 60 subjects. All of these subjects will be healthy older men     between the ages of 60-85 years old who are not on testosterone therapy. Subjects that are     screened who have any clinically significant abnormalities detected on their screening     physical exam or laboratory testing (e.g. Prostate Specific Antigen > 4), who have a history     of prostate cancer, polycythemia, or who cannot take testosterone will not be included.      If a subject is eligible to participate after initial screening, that subject will take     medications to adjust their hormone levels and have tests performed that measure insulin     sensitivity and adiposity before and after these hormone medications. The outcomes that will     be measured are: 1) insulin sensitivity, 2) hormone levels (total and free testosterone     levels, sex hormone-binding globulin levels) and 3) body composition and abdominal adiposity.   "
216143|NCT00680823|"     Objective: To determine if lower paracervical intramuscular ropivacaine injection is an     effective treatment for pediatric headache in an emergency department setting.   "
216144|NCT00680836|"     The purposes of this study are to estimate the burden of disease due to chronic     gastrointestinal illness in PG veterans, to evaluate whether Small Bowel Bacterial Overgrowth     (SBBO) is associated with chronic diarrhea in PG veterans, and to determine whether     eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG     veterans.   "
216147|NCT00680875|"     The purpose of this research is to create an effective, disseminable, and exciting     computer-based tobacco prevention program for 5th and 6th grade students. The goal of this     school-based program is to decrease children's behavioral intentions and willingness to use     tobacco, and to prevent or delay their initiation of tobacco use.      We will augment the 5th grade program with a booster program in 6th grade, and evaluate the     long-term efficacy of the entire tobacco prevention program by conducting a randomized     controlled trial in elementary and middle schools.   "
216148|NCT00680888|"     Observational study aimed to describe the adherence in a population of adolescents and     children treated on quetiapine from a first psychotic episode whose more important secondary     objective is to identify possible predictive factors influencing the adherence to treatment     with Quetiapine   "
216149|NCT00680901|"     This is an international multi-center trial that will enroll patients with locally advanced,     unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose     tumors have amplification of the ErbB2 (HER2) gene. The trial will investigate whether     lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx),     extends the time to progression and overall survival. Tumor ErbB2 (HER2) status must be known     before trial entry. CapeOx is administered to all patients, and patients will be randomly     assigned to receive either lapatinib or placebo.   "
216150|NCT00680914|"     The purposes of this study are:      To demonstrate the immunogenicity in terms of antibody response following primary vaccination     of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™     when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during     the first 6 months of life.      To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and     serious adverse events following primary vaccination of Korean infants with the pneumococcal     conjugate vaccine GSK 1024850A.   "
216151|NCT00680927|"     The purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics     of the Reveal® XT in a clinical setting and to verify overall system performance, R-wave     sensing performance, to obtain user feedback, from both patient and physician, and collect     data on device safety.   "
216152|NCT00680940|"     The purpose of this study is to determine whether Mycobacterium w in combination with     Paclitaxel plus Cisplatin are effective in Advanced Non Small Cell Lung cancer.   "
216153|NCT00680953|"     Evaluate the efficacy and safety of denosumab in the treatment of involutional     (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral     fracture(s)   "
216154|NCT00680966|"     The purpose of this study is to determine whether it is more effective to treat adolescents,     with diagnoses of both depression and substance use disorder, with a treatment addressing the     substance use first and then treating the depression or to first treat the depression and     then treat the substance use or whether treating both disorders simultaneously is most     effective.      It is expected that treatment of both disorders at the same time will be the most effective.   "
216155|NCT00680979|"     This study will examine whether interpersonal psychotherapy (IPT) can help reduce excessive     weight gain in adolescent girls. It will compare the effectiveness of IPT with a teen health     education program in preventing weight gain.      Adolescent girls between 12 and 17 years of age who are at risk for becoming overweight     adults, by virtue of being above average weight and experiencing episodes of loss of control     over eating, may be eligible for this study. Candidates are screened in two visits with the     following procedures:      Visit 1        -  Height and weight measurements.        -  Interview and questionnaires about the child s general health, social and psychological          functioning and eating patterns and behaviors.      Visit 2        -  Physical examination, blood and urine tests.        -  DXA scan to measure body fat, muscle and bone mineral content.        -  Laboratory test meal. The child fills out a rating scale about her level of hunger and          is then given a food buffet from which she is instructed to eat as much as she wants.          Immediately after eating, the child again completes the hunger rating forms.        -  Interview about the child s mood and psychological functioning.      Participants are assigned at random to either the IPT or teen health education program. All     participants have a 1- to 1 1/2-hour individual session with a therapist, followed by 12     weekly group sessions of 1 1/2 hours each in their assigned program. They are assessed at the     end of the program with questionnaires and body measurements. They return to the clinic after     6 months for body measurements, blood test, DXA scan, questionnaires, interview and a test     meal, and again at 1 year for body measurements, questionnaires and a DXA scan.   "
216156|NCT00680992|"     To determine how safe denosumab is in treating subjects with giant cell tumor of bone   "
216157|NCT00681005|"     Backgrounds & Aims: Proton-pump inhibitor (PPI) test has been proposed as a valuable tool in     the diagnosis of gastroesophageal reflux disease (GERD) in Western populations. We assumed     that a higher prevalence of poor metabolizers in Chinese population might affect the     diagnostic accuracy of a PPI test.      Methods: In this open-label, randomized trial, patients with symptoms suggestive of GERD were     randomly assigned to receive a 2-week test with daily rabeprazole 40-mg or daily pantoprazole     80-mg after diagnostic endoscopy. Therapeutic response was assessed with a five-grade daily     record. Genotypes of cytochrome P450 (CYP) 2C19 polymorphism were determined.   "
216158|NCT00681018|"     To evaluate weight gain of preterm infants fed fortified human milk.   "
216159|NCT00681031|"     Primary objective:      To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry     potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by     gpELISA) from pre-vaccination to 4 weeks post-vaccination      Secondary objectives:      To describe the safety profile of ZOSTAVAX® at minimum release specification approaching     expiry potency   "
216160|NCT00681044|"     RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells     by stopping them from dividing or killing them. Giving colony-stimulating factors, such as     G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the     blood so they can be collected and stored. Chemotherapy is then given to prepare the bone     marrow for the stem cell transplant. The stem cells are then returned to the patient to     replace the blood-forming cells that were destroyed by the chemotherapy.      PURPOSE: This phase II trial is studying the side effects of high-dose melphalan given     together with stem cell transplant and to see how well it works in treating patients with     immunoglobulin deposition disease or light-chain deposition disease.   "
216165|NCT00681122|"     This observational study is restricted to postmenopausal women with hormone-sensitive early     breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or     letrozole, according to the current product SmPCs. There is no Investigational Medicinal     Product (IMP) to be taken in this observational study. The adjuvant AI medication must not     have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In     Daily practicE through Educational approach), impact of educational material on women's     compliance and persistence rates will be evaluated.   "
216166|NCT00681135|"     The purpose of this study is to determine whether the use of a sonic toothbrush alone is more     effective than two other toothbrushing protocols on dental plaque elimination in patients     with fixed orthodontic appliances.   "
216167|NCT00681148|"     The purpose of this study is to see if botox injection into the prostate during seed     implantation (brachytherapy) for prostate cancer a) improves urinary symptoms or avoids need     for urinary tract instrumentation over the 6-8 month post-operative period when one wants to     avoid manipulating the radioactive seeds, and b) speeds up the drop in PSA. Patients will be     randomized to botox vs saline injection, at the completion of the seed implantation     procedure.   "
216168|NCT00681161|"     The purpose of this study is to determine if obstructive sleep apnea (OSA) causes autonomic     dysfunction independent of its effects on hyperglycemia.   "
216169|NCT00681174|"     The main hypothesis of this study is that preoperative administration of controlled-release     (CR) oxycodone may reduce acute postoperative pain and improve time to discharge from the     post-anesthesia care unit in patients undergoing video-assisted thoracoscopy for spontaneous     pneumothorax.      The study drug will be compared with intravenous morphine administered 30 minutes before the     end of anesthesia.   "
216170|NCT00681187|"     The primary aim of this study is to assess which method of lanreotide Autogel administration     patients with neuroendocrine tumours prefer - self/partner administrations or healthcare     provided administrations. The study will also assess if self/partner administration can be     performed without loss of efficacy and with a preserved safety profile. The impact of     self/partner administration on resource utilisation and costs will be studied. In addition,     we will also assess the healthcare provider's experience of the two administration practices.   "
216171|NCT00681200|"     High blood pressure is a common health problem among people in the United States. This study     will compare the effectiveness of a meditation program versus a health education program at     decreasing stress and lowering blood pressure levels among African-American adults with high     blood pressure.   "
216172|NCT00681213|"     Comparison of outcomes/safety/and tolerability of SRL/FK/Pred vs. FK/MMF/Pred vs.     SRL/Neoral®/Pred in cadaveric and non-HLA identical LRD kidney transplants.   "
216194|NCT00673790|"     This study is being done to see if the blood pressure and metabolic effects of an approved     drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and     placebo in hypertensive patients.   "
216174|NCT00681239|"     The modified Atkins diet (MAD) is a relatively new, alternative dietary therapy for     intractable childhood and adult epilepsy. Recent evidence suggests that a strict, highly     ketotic, first month may be advantageous to both immediate and long-term efficacy. KetoCal®     is a pre-mixed powder that can be used to create a 4:1 ketogenic diet shake as a meal     substitute. The investigators hypothesize that substituting KetoCal® for a lunch during the     initial month of the MAD will lead to improved seizure reduction over the MAD alone, as well     as improved tolerability and lipid values.   "
216175|NCT00681252|"     The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201     restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.   "
216176|NCT00681265|"     This study is an exploratory trial evaluating the tear film break-up time after a single eye     drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear     film break up time will be greater for test than control eye.   "
216177|NCT00681278|"     This study will address the treatment rate and control rate of hypertension, treatment     pattern and factors to affect blood pressure control by examining (retrospective) medical     records of hypertension patients having Type 2 Diabetes mellitus, among outpatients coming to     the Endocrinology Department in 20 general hospital settings nationwide.   "
216178|NCT00681291|"     This is a prospective, randomized, controlled, third-party blinded, multicenter,     interventional evaluation of inguinal hernia repair comparing Strattice to light weight     polypropylene mesh. Performance and outcomes measures to be compared include postoperative     resumption of activities of daily living, nature and incidence of short- and long-term pain     and complications, and incidence of hernia recurrence.   "
216179|NCT00681304|"     This is a pilot study. The main purposes for doing the study are to see if there is a     relationship between lumpectomy volume and position as measured by USEI and by CT. This is     not a study to see if the use of USEI is better than the current method of using CT for daily     radiation therapy positioning.   "
216180|NCT00681317|"     This is a study to evaluate safety, tolerability, PK and PD effects of orally administered     AZD6280 after single and repeated ascending doses.   "
216181|NCT00681330|"     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402     restricted epitope peptides URLC10, TTK, and KOC1, emulsified with Montanide ISA 51.   "
216182|NCT00681343|"     To observe in a randomized prospective pilot study the effectiveness and toxicity of     Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD)     kidneys, compared with our standard treatment protocol of Zenapax® and maintenance     immunosuppression   "
216183|NCT00681356|"     Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients     undergoing total knee replacement   "
216184|NCT00681369|"     the purpose of this study is to describe the way Faslodex is used in France, in patients     suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to     determine patients profile   "
254574|NCT02805699|"     The purpose of this study is to confirm the efficacy and safety of BaofeiKang Granule in the     treatment of Combined Pulmonary Fibrosis and Emphysema patients.   "
216185|NCT00681382|"     This study was aimed at clarifying how the asthma medication is used in practice and how     asthma affects everyday life. Total of 106 GPs were asked to recruit patients using inhaled     steroid as maintenance treatment for asthma to take part in a telephone survey. Altogether     142 patients were interviewed.   "
216186|NCT00681395|"     To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination     ABT-143 relative to that from the co-administration of the two monotherapies.   "
216187|NCT00681408|"     Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20%     chance of progression to cirrhosis. It is closely associated with obesity, hyperlipidemia and     insulin resistance. Therapy usually includes recommendations to increase exercise and to     begin weight reducing diets but these goals are variably achieved and their relative effects     in conjunction with pharmacological intervention have not been well defined. Moreover, these     lifestyle changes can confound results of treatment trials if not quantified through     conditioning testing and measures of body fat. Polyunsaturated fatty acids, especially     formulation rich in omega-3, are widely accepted and endorsed in the medical community for     their beneficial effects on hyperlipidemia and coronary disease risk reduction. Recent data     suggests that omega-3 fatty acids ameliorate hepatic steatosis in humans and in animal models     of NASH by reducing hepatic fat content. We hypothesize that a one year course of omega-3     fatty acid (3gm/day) will produce improvement in NASH histological injury independent of     changes in weight (BMI) or degree of conditioning measured by the lactate threshold. The     effects of the supplement will be compared to a placebo group and controlled for these     lifestyle changes.   "
216188|NCT00673712|"     The main goals of the study are as follows: (1) to determine the correlation between pain     management using continuous infusion of local anesthetics and the incidence of pneumonia and     surgical infection in cardiac surgery patients; and (2) to evaluate the relationship between     hospital-acquired pneumonia and surgical infection and patient outcomes, including length of     hospital stay.   "
216189|NCT00673725|"     To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD   "
216190|NCT00673738|"     This research is being done to find out if a treatment consisting of a combination of     thoracic radiotherapy with cetuximab, given together, and followed by chemotherapy with     docetaxel and cetuximab (also given together) will kill the cancer cells in the patient's     body and shrink the size of their tumor without causing unacceptable side effects. This may     allow patients to live longer or decrease the frequency and/or severity of the symptoms     caused by the cancer without increasing the frequency and/or severity of the symptoms caused     by the treatment.   "
216191|NCT00673751|"     The aim of the study is to investigate the effect of the enteric hormone Glucagon-like     Peptide (GLP-2) on patients with short bowel syndrome   "
216192|NCT00673764|"     To evaluate the effect of 2 different lubricant eye drops on visual function of patients with     dry eye   "
216193|NCT00673777|"     The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201     restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.   "
216195|NCT00673803|"     Studies showed that a sharp posterior optic edge of an intraocular lens (IOL) inhibits     migration of lens epithelial cells in between posterior capsule and optic of the IOL and     therefore reduces the rate of posterior capsule opacification (PCO). In present time most     IOLs implanted have a sharp posterior optic edge. Due to differences in IOL production     different IOLs have different rates of PCO.      Progression in cataract surgery technique allow phacoemulsification through micro-incisions.     Therefore there is need for IOLs that can be implanted through incisions of about 2.5 mm.      This study investigates the effect of two different hydrophobic acrylic IOLs with a sharp     posterior optic edge on the rate of PCO after implantation through a micro-incision. The     results will be compared intraindividually.   "
216196|NCT00673816|"     This open-label study will pilot the use of systemic sunitinib malate, a dual inhibitor of     vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF), in five     participants with Von Hippel-Lindau (VHL) to investigate its potential efficacy as a     treatment for retinal angiomas. Participants will have visual dysfunction with either visual     acuity loss or visual field loss from retinal angiomas secondary to genetically confirmed     VHL. This open-label study will pilot the use of systemic sunitinib malate in five     participants to investigate its potential efficacy as a treatment for retinal angiomas     associated with VHL. Participants will receive nine months of sunitinib malate therapy (six     cycles total - one cycle consists of 50 mg oral dose once daily for four weeks followed by a     two week rest period). The primary outcome will be a change in the best-corrected visual     acuity of more than or equal to 15 letters from baseline to the Week 36 visit. The secondary     ocular outcomes will focus on retinal thickness and leakage of the retinal angioma at the     Week 36 visit. Optical coherence tomography will document changes in retinal thickening and     fluorescein angiography will be used to determine leakage of the retinal angioma.   "
216197|NCT00673829|"     The purpose of this study is to collect data on the safety and effectiveness of 2nd     generation designer T cells in patients with breast cancer. Designer T cells are prepared by     collecting white blood cells from the participant, and then modifying these cells in the     laboratory so that they recognize the tumor antigen (CEA). These modified cells are then     given back to the participant so that they can attack and kill tumor cells.   "
216198|NCT00673842|"     This study will assess whether an implantable defibrillator will increase the likelihood of     survival in patients who have had a heart attack in the prior 5 years, have abnormal test     results from a 24 hour heart monitor, and who have low normal heart function.   "
216199|NCT00673855|"     To evaluate the acute comfort and blurring profile between two artificial tears in dry eye     patients.   "
216200|NCT00673868|"     This study examines the immunologic and virologic effects of prophylactic CMV specific CTL in     recipients of T cell depleted stem cell transplant (TCD SCT) at Duke University Medical     Center (DUMC), by measuring levels of CMV DNA and virus specific T cell precursors at     intervals post-infusion.   "
216201|NCT00673881|"     The objectives of the study are:        1. To evaluate the effect of ABT-335 (choline fenofibrate) on several parameters of RCT          (reverse cholesterol transport) in men and post-menopausal women diagnosed with          dyslipidemia (i.e., low high-density lipoprotein [HDL] cholesterol levels and elevated          triglyceride [TG] concentrations).        2. To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL.        3. To obtain pilot data for power calculations for subsequent comparative study.   "
216202|NCT00673894|"     This study will investigate the effect of glutamine, an amino acid, on GLP-1, insulin and     glycaemia in normal lean subjects and patients with type 2 diabetes.   "
216203|NCT00673907|"     The study intends to focus on health effects and symptoms related to particle exposure from     wood burning stoves      The objective is to determine whether moderate exposure to particles from wood smoke in a     real life situation causes an systemic inflammatory response in peripheral blood or in lower     airways. 24 healthy subjects (normal healthy subjects and mild asthmatics to study the     asthmatic response) is selected for the study. A randomized double blind crossover procedure     will be followed with a PM exposure concentration of 200ug/m3, 400ug/m3 or clean air as the     control exposure. Exposure will take place in a climate chamber using wood burning in an     appropriate wood stove.   "
216204|NCT00673920|"     This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in     patients with active rheumatoid arthritis who have an inadequate response to methotrexate     therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on     Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3)     infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment     period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a     single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2     will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a     stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated     time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial     is 300.   "
216205|NCT00673933|"     In this multicenter study, patients with dark skin and acne vulgaris will be included. The     patients will receive treatment with MAL PDT and placebo PDT.   "
216206|NCT00673946|"     To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute     bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within     72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage     points above the true measurements is significantly lower in comparison to those whose     monitors display true saturations.   "
216207|NCT00673959|"     To evaluate the acute comfort and blurring profile between two artificial tears products in     dry eye patients   "
216208|NCT00673972|"     The purpose of this study is to compare postprandial distress syndrome and epigastric pain     syndrome in demographics psychological features, infection of Helicobacter pylori, gastric     emptying and therapeutic response to lansoprazole.   "
216209|NCT00673985|"     The main objective of this study is to assess the safety and effectiveness of the Edwards     Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the     treatment of occlusive superficial femoral artery (SFA) disease by reducing the     re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone   "
216210|NCT00673998|"     An age-related decrease in muscular strength may have a detrimental effect on muscle fatigue     and recovery. To date, only one study has determined the effect of varied rest intervals (RI)     between exercise sets in active younger and older women. They reported that active younger     and older women require similar RI between sets to recovery full isokinetic knee extension     peak torque (PT). However, we are unaware of any published studies comparing RI PT recovery     between younger and older men. Thus, the purpose of this study was to compare the effect of     two different RI's between sets of isokinetic knee extension exercise on PT, and Total Work     (TW) between untrained younger and older men.   "
216211|NCT00674011|"     This research study will look at the effect of an anti-angiogenesis medication called     Bevacizumab on blood vessels. Anti-angiogenesis medicines fight cancer by cutting off a     tumor's blood supply, starving the tumor of nutrients and oxygen. Previous studies have shown     these types of drugs can cause hypertension. The purpose of this study is to help researchers     better understand why these drugs cause hypertension. This information will assist     researchers in learning how to control this side effect.   "
216212|NCT00674024|"     Background:        -  Pazopanib is an experimental drug that was designed to enter cancer cells and block the          activity of proteins that are important for cancer cell growth and survival.        -  This is the first study in which pazopanib is given to patients with different degrees          of liver function. The safe dose for patients with normal liver function is already          known.      Objectives:        -  To determine the safety and side effects of pazopanib given at different dose levels to          patients with cancer who have different degrees of liver function.        -  To find out how much pazopanib is in the blood at specific times.        -  To determine if pazopanib is effective in treating advanced cancer in patients with          different degrees of liver function.      Eligibility:      - Patients 18 years of age and older with an advanced solid tumor or lymphoma that cannot be     treated successfully with standard therapies and who have normal or abnormal liver function.      Design:        -  Treatment:        -  Patients are divided into 4 groups, based on their liver function. The first three          patients in each group receive a low dose of pazopanib. The next three in each group          receive a higher dose of pazopanib if no serious side effects were reported in the          previous three. The dose is increased in succeeding groups of three patients until the          maximum study dose is reached.        -  Patients take pazopanib once a day by mouth in 21-day treatment cycles. Treatment          continues until the cancer worsens, the patient develops severe side effects, the          patient no longer wants to continue the study, or the doctor removes the patient from          the study for other reasons.        -  Monitoring:        -  Blood pressure: Patients monitor and record their blood pressure twice a day after          starting treatment.        -  Blood tests: Patients have weekly routine blood tests. In addition, at week 3 of the          first cycle and again after the highest safe dose has been determined, several blood          samples are collected at frequent intervals to determine how the body handles the drug.        -  Imaging studies: X-rays or scans or both are done to measure the extent of disease every          3 cycles.        -  Physical examinations are done at periodic intervals.   "
216213|NCT00674037|"     Patients' recruitment is difficult in clinical trial. Financial incentives are frequently     proposed to clinicians in private funded trials. However, the effect of these financial     incentives has never been evaluated.      The purpose of this study is to evaluate the effect of financial incentive on the rate of     recruitment of patients in a cohort study.   "
216214|NCT00674050|"     This study will investigate the effects of inhaled albuterol & fluticasone on one dose of TI     Inhalation Powder. A total of 12 eligible subjects will be enrolled.   "
216215|NCT00674063|"     Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg     with moderate to severe Chronic Plaque Psoriasis   "
216216|NCT00674076|"     We hypothesize the width air-colum of retropalatal region and tongue voulme by ultrsound     through submental area is different between normal control with those with obstructive sleep     apnea syndrome who was comfirmed by polysomography.   "
216217|NCT00674089|"     Vitamin A is an essential micronutrient for the normal functioning of the visual system,     growth and development, immunity and reproduction. Its deficiency causes anemia, growth     retardation and xerophthalmia. Vitamin A deficiency also increases the incidence and/or     severity of infectious episodes and affects child survival. Reduced child survival is the     most severe and potentially the most widespread consequence of Vitamin A deficiency.     Improvement in vitamin A status is now regarded as one of the most cost effective preventive     measures for the reduction of child mortality and morbidity.      Over the past decade several studies have examined the effect of vitamin A on reducing     mortality among children aged ≥6months at the time of intervention. Impact of vitamin A     supplementation can significantly reduce total mortality but it is only established through     supplementation programs in children age 6 months or older. It was assumed that breast milk     protects infants from vitamin A deficiency, but recent evidence has challenged this. Infants     born with low stores of vitamin A and if the mother breast milk has a low concentration of     vitamin A, as found in developing countries, the infants might be unable to meet their daily     requirements and improve body reserves. There is association between mortality and degree of     vitamin A deficiency, greater the degree of deficiency, higher the mortality.      The role of vitamin A in child survival is now well established and over 60 countries have     vitamin A supplementation programs nationally. However, most are still using vitamin A     supplements in the second half of infancy, even though over 75% of all under 5 deaths take     place in the first 6 months of life. If neonatal vitamin A supplementation can be found to be     effective and a service delivery mechanism also found, this will represent a major advance in     reaching the MDG 4 targets. This is thus persuasive reason to explore this particular     preventive strategy, especially in terms of packaging with other postnatal care activities.     However, given that in some instances it has been difficult to disentangle the effect of     vitamin A dosing from concomitant vaccinations such as BCG, the current evidence needs     further evaluation in effectiveness settings. We propose to evaluate the effectiveness of     early neonatal vitamin A administration (single dose 50,000 units) to the newborn to see its     effect on infant mortality less than 6 months of age as part of postnatal package through     National Program.      Government has launched the National Program for Family Planning and Primary Health Care     since April 1994. Primarily it is being implemented in the community through Lady Health     Workers (LHWs) of the National Program.      The LHWs are females, with a minimum of eight years of education, residents of the locality     in which they are working. The Programme is being currently implemented in all the districts     throughout the country and 93,000 LHWs are working covering primarily women and children of     the rural population. These LHWs deliver services related to family planning, maternal and     child health, immunization, nutrition and treatment of minor ailments to her average     registered population of 100-150 households or ~1000 population. Over 3,000 Supervisors have     been recruited and trained to supervise the work of LHWs.   "
216218|NCT00674102|"     The safety, tolerability, efficacy and pharmacokinetics of ASA404 when administered in     combination with paclitaxel and Carboplatin are assessed. ASA404 is administered     intravenously every 21 days to Japanese patients with Non small cell lung cancer.   "
216219|NCT00674115|"     Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to     compare effects on stomach acid; 30 participants will continue treatment for 7 days and will     have repeat evaluations at Day 7. The other 30 participants will receive a single     administration of sodium bicarbonate.   "
216220|NCT00674128|"     The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as     effective as polyglactin 910 suture for surgical closure of cardiac device pockets.   "
216221|NCT00674141|"     The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in     relapsing MS patients   "
216222|NCT00674154|"     The primary aim of the study is to assess whether 6-months of vitamin D supplements can     decrease PTH compared with placebo treatment in primary hyperparathyroidism.   "
216223|NCT00674167|"     -  To assess the radiological response, curative resection rate of preoperative          docetaxel/cisplatin/capecitabine(DCX).        -  To correlate treatment response with serum RUNX3 promoter hypermethylation.        -  To determine the toxicities of preoperative DCX        -  To determine the time to progression/overall survival of preoperative DCX   "
216224|NCT00674180|"     This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in     2001 that evaluated the costs and effects of incremental components of a weight-loss program.     Data analysis will involve cross-sectional and predictive analyses and may include:     regression analyses to determine predictors of weight loss and cardiovascular risk,     correlations between weight reduction strategies and biological indices, and interactions     between biomarkers of inflammation and traditional cardiovascular risk factors. This data     will also be available for economic modeling.   "
216225|NCT00674193|"     This laboratory study is evaluating how well dactinomycin and vincristine work in treating     young patients with cancer. Studying samples of blood and urine in the laboratory from     patients with cancer may help doctors learn how dactinomycin and vincristine affect the body     and how patients will respond to treatment.   "
216226|NCT00674206|"     The purpose of this study is to investigate if the combination of gemcitabine and oxaliplatin     is effective for triple negative breast cancer.   "
216227|NCT00674219|"     The objective of this study was to obtain preliminary open-label data on the efficacy and     tolerability of memantine, an anti-glutamatergic medication with a unique pharmacodynamic     profile, in individuals with OCD and individuals with GAD. Because glutamatergic     hyperactivity in frontal and frontal-subcortical circuits may play a role in the symptomatic     expression of OCD, and possibly GAD, agents that reduce glutamatergic neurotransmission     should provide unique anti-stress and anti-obsessional benefits. Memantine is a specific,     uncompetitive antagonist at the NMDA receptor that blocks sustained activation of the NMDA     receptor by high concentrations of glutamate under pathological conditions but rapidly leaves     the NMDA channel upon transient physiological activation by low concentrations of glutamate.   "
216228|NCT00674232|"     This study aims to compare the efficacy, side effects profile and acceptability of a single     dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local     protocols for the treatment of incomplete abortion.   "
216229|NCT00674245|"     The purpose of this research study is to determine if treatment with pantoprazole 40 mg daily     versus a placebo improves sleep quality in patients with gastroesophageal reflux disease     (GERD). Another purpose is to determine if treatment with pantoprazole 40 mg once daily     versus a placebo improves sleep outcomes in patients with gastroesophageal reflux disease     using spectral analysis of sleep electroencephalogram (EEG).   "
216230|NCT00674258|"     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402     restricted epitope peptides URLC10, TTK and KOC1 emulsified with Montanide ISA 51.   "
216231|NCT00674271|"     The aim of this study is to investigate the relation between individual differences in     pattern recognition molecules (PRM's) in the innate immune system and the prevalence and     development of vascular complications in patients with type 2 diabetes.      This is based on the hypothesis that pattern recognition molecules (PRM's) in the innate     immune system contributes to a chronic low grade inflammation in diabetic patients. Variation     in PRM's - at the genome, proteome as well as the functional level - are therefore associated     with the degree of chronic low grade inflammation, and probably also with the prevalence of     vascular complications.   "
216232|NCT00674284|"     We study the relationship between patient outcomes and sequential changes of serum cortisol     level.   "
216233|NCT00674297|"     The purpose of this study is to determine whether a drug named Fluvastatin is beneficial and     safe in reducing the risk of cardiovascular disease and blood clots in patients with     antiphospholipid antibodies or Antiphospholipid Syndrome (APS).   "
216234|NCT00674310|"     The objective of this study was to assess the single dose bioequivalence of Roxane's     Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions     using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.   "
216235|NCT00674323|"     This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination     treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving     complete regression of polyps in patients with symptomatic macular polypoidal choroidal     vasculopathy.   "
216249|NCT00674505|"     To evaluate the procedural safety and filter efficiency of the FiberNet® Embolic Protection     System when used in conjunction with the Boston Scientific Express SD Stent System for     primary stenting of ostial atherosclerotic renal lesions in patients with atherosclerotic     renal artery stenosis.   "
216303|NCT00675207|"     The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and     brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy     (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension.   "
216236|NCT00674336|"     Norwalk virus and related Norwalk-like viruses are the most common cause of outbreaks of     stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United     States. These viruses are sometimes found in drinking water, ice, shellfish and in other     foods. They can be spread easily from contact with water, food, objects or hands that have     even small amounts of feces from someone who was sick.      The purpose of this research study is to the effectiveness of high hydrostatic pressures     processing (HPP) treatment on norovirus infected shellfish. Norwalk virus can survive in     shellfish and still be able to cause sickness. HPP inactivates microorganisms living both on     the surface and on the interior of the food. The goal of the study is to determine whether     HPP treatment on oysters spiked with norovirus will reduce infection rates in people     consuming raw infected oysters.   "
216237|NCT00674349|"     Ovarian cancer is the first mortality rate of gynecologic malignancies. The incidence of     ovarian cancer increased in recent 10 years and it has become the ninth cause of malignancies     in the women in Taiwan. From the above-mentioned data, ovarian cancer indeed is a disease     that should be respected, however, there were only few of research work focusing on it in     Taiwan. Despite the widespread use of aggressive cytoreductive surgery and the introduction     of chemotherapy regimens, the overall survival has changed little over the last two decades.     The basic problem in treating epithelial ovarian cancer is that once it has spread beyond the     ovary, it is exceedingly difficult to control and ultimately to cure. More than 70% of     ovarian cancer patients were advanced stage when diagnosed. To study the mechanisms of     carcinogenesis, progression, and metastasis of ovarian cancer will help us understand this     disease and develop new treatment strategies for ovarian cancer in the future.      We have established an ascitogenic itnraperitoneal tumor cell line-WF3 in the mouse model in     our previous two-year project of NSC grant (grant number (NSC90-2314-B-002-457 and     NSC91-2341-B-002-315). Our group found that, mesothelin, this molecule is highly related with     the carcinogenesis, tumor progression and tumor metastasis in our animal model and human     cancer tissues. To further evaluate the role of mesothelin in ovarian cancer and elucidate     the potential of mesothelin as a target antigen for immunotherapy,   "
216238|NCT00674362|"     To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with     stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission     in patients with moderate to low disease activity rheumatoid arthritis   "
216239|NCT00674375|"     The evaluation of chest pain in the primary care office is a challenging problem, with many     patients suffering from missed diagnoses of acute myocardial infarction and many other low     risk patients receiving unnecessary evaluations. This project will provide primary care     physicians evaluating patients complaining of chest pain with computerized alerts that     differentiate high-risk patients from low risk patients, and provide individualized     evaluation and treatment recommendations.   "
216240|NCT00674388|"     The Study is designed to collect information about adverse events that occur in children     undergoing anesthesia in participating hospitals. Demographic information will be collected     on all anesthetics. An analysis of each adverse event will be performed and entered into the     database. From this information we will devise strategies to prevent these adverse events.   "
216241|NCT00674401|"     The purpose of this study is to assess the value of ablation of high frequency sources     following circumferential pulmonary veins isolation in patients with paroxysmal and     persistent atrial fibrillation.   "
216242|NCT00674414|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow     to the tumor. It is not yet known whether giving everolimus together with trastuzumab is more     effective than giving trastuzumab alone in treating women with breast cancer.      PURPOSE: This randomized phase II trial is studying trastuzumab and everolimus to see how     well they work compared to trastuzumab alone before surgery in treating patients with breast     cancer that can be removed by surgery.   "
216243|NCT00674427|"     This study is for patients with relapsed of disease after allogeneic bone marrow      The donor's T cells are activated by exposure to 2 compounds or antibodies that bind (or     stick to) two compounds on T cells called CD3 and CD28. When these antibodies stick to both     CD3 and CD28 on the T cells, the T cells becomes stimulated (or activated) and grows. CD3     and CD28 are the coating of a T cell and a T cell is part of the body's immune system.      It is believed that when T cells are exposed to both of antibodies to CD3 and CD28 compounds     at the same time, they become activated or stimulated and may be more effective in fighting     infections or cancer cells. We call this therapy activated donor lymphocyte infusions, or     activated DLI (aDLI).      This current study is being performed to see whether it is safe and effective to administer     higher doses of activated DLI or repeated doses of activated DLI.      All patients will receive standard donor lymphocyte infusions first, and in addition will     receive activated donor lymphocytes approximately 12 days later (DLI followed by aDLI).     Depending on the response to this treatment, and depending on possible side effects (such as     graft-vs-host disease as described below), patients in remission will then receive additional     aDLI every 3 months for 4 more times, and patients not in remission within 6-12 weeks will     receive higher dose aDLI. The timing of the higher dose aDLI will be determined by your     physician depending on your disease and the rate of progression of your disease. The aDLI can     be given as early as 6 weeks, or as late as 12 weeks (3 months).   "
216244|NCT00674440|"     Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these     children may require surgery. In this study, researchers affiliated with the University of     Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of     hyperinsulinism that may be cured by surgery. Eligible participants in this study will have     positron emission tomography (PET) scans with F-DOPA prior to surgery.   "
216245|NCT00674453|"     The objective of the study is to demonstrate the effects that lasofoxifene has on serum     markers of bone metabolism.   "
216246|NCT00674466|"     This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The     objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with     CJC-1134-PC in patients who are currently on metformin monotherapy.   "
216250|NCT00674518|"     This study will compare three methods of counseling to determine which is most effective at     motivating participants to adopt healthy lifestyle habits. The three methods are: individual     counseling, working in groups with a health educator, and receiving advice from a physician.     The health goals for subjects in this study are: 1) increase physical activity to 30 minutes     each day, 2) reduce fat intake to less than 30% of total calories, 3) increase consumption of     fruits and vegetables to at least 5 servings each day, and 4) reduce percentage of body fat     to a healthy level.   "
216251|NCT00674531|"     Atherosclerosis is one of the first causes of morbidity-mortality in industrialized     countries. Numerous works suggest that some infectious agents could be involved in the     inflammatory process leading to the development of this pathology, such as Chlamydophila     pneumoniae, cytomegalovirus or herpes simplex virus. Enteroviruses are small RNA viruses that     have been incriminated in various acute or chronic cardiac diseases (pericarditis,     myocarditis, dilated cardiomyopathy) and exhibit a tropism for vascular endothelia. Different     clinical and experimental arguments suggest that they could play a cofactor role in the     occurrence or maintenance of atherosclerosis lesions. A multicenter study developed in     collaboration with colleagues of the University Hospital of Reims (France) showed that it was     frequent to detect enterovirus RNA in cardiac biopsies from patients with myocardial     infarction. Furthermore, a pilot study conducted in the University Hospital of Saint-Etienne     (France) on atheromatous arterial samples from 18 patients allowed the detection of     enterovirus RNA in 20% of them.   "
216252|NCT00674544|"     Childhood obesity and low fitness tracks into adulthood and carries significant     co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel     lifestyle intervention in preschool children in the French and German speaking part of     Switzerland during one school-year results in a smaller increase in body mass index (BMI) and     a larger increase in aerobic fitness.   "
216253|NCT00674557|"     RATIONALE: Exemestane may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. ATN-224 may stop the growth of breast cancer by blocking blood flow     to the tumor. It is not yet known whether giving exemestane together with ATN-224 is more     effective than giving exemestane alone in treating patients with recurrent or advanced breast     cancer.      PURPOSE: This randomized phase II trial is studying the side effects of exemestane given     together with or without ATN-224 and to see how well it works in treating postmenopausal     women with recurrent or advanced breast cancer.   "
216254|NCT00674570|"     This is a research study examining the use of two medications, Hydrocortisone and     D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear     responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder     (PTSD). These responses will be tested using a fear learning and memory task administered by     computer.   "
216255|NCT00674583|"     The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal     vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine     antibody response against meningococcal serogroup C disease.   "
216282|NCT00674934|"     Multiple sclerosis (abbreviated MS) is an autoimmune condition in which the immune system     attacks the central nervous system (CNS), leading to demyelination. This study will     investigate the use of far infrared radiation for MS control, management and treatment.   "
216283|NCT00674947|"     Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with     relapsed or refractory solid tumors.   "
216256|NCT00674596|"     Long pentraxin 3 (PTX3) is a recently discovered multimeric inflammatory mediator     structurally linked to CRP and serum amyloid P-component. There is no data about the effects     of Renin angiotensin system blockage (RAS) on PTX3 levels in diabetic patients with     proteinuria. The aim of this study was to find out whether the beneficial effects of RAS     blockage in diabetic proteinuria has any relation with the alteration of PTX3 levels. We     searched for the effects of ACE inhibitor ramipril on the clinical and laboratory parameters     of diabetic patients with proteinuria.   "
216257|NCT00674609|"     The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in     the management of subjects with intractable cancer-related pain.   "
216258|NCT00674622|"     Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition     affecting young and middle-aged adults-most commonly manual workers and recreational     athletes. It results in significant pain and disability, limiting work productivity and an     individual's ability to participate in and enjoy recreational activities. Like many other     chronic musculoskeletal conditions LE often shows an incomplete response to acute treatments,     leading to chronic pain and disability. Prolotherapy (PrT) involves the injection of an     irritant or proliferant solution into tendons, ligaments, and joints to treat chronic     musculoskeletal pain. We will be conducting a 3-group randomized, blinded trial to determine     the safety and efficacy of PrT injections in the treatment of chronic LE. Additionally, we     will seek to determine to what extent any beneficial effect of PrT is derived from deep     needle placement vs. a specific effect of the injectate. The specific aims for this study     are: 1) to determine if PrT is a safe, well-tolerated, and effective treatment for     individuals with chronic LE; and 2) to determine whether the deep needle placement alone is     responsible for the therapeutic effect, independent of injectate. In order to accomplish     these aims, we will measure indicators of pain and disability using self-rating scales,     questionnaires and physical measures. Subjects will be stratified prior to randomization on     two factors: 1) unilateral vs. bilateral LE; and 2) treatment with steroids within the prior     6 months. If effective, subjects receiving PrT will show greater reduction of pain and     functional impairment compared with the other two groups. This research will guide future     studies on prolotherapy by determining what may be the best control condition. Additionally,     further studies may explore the mechanism responsible for any beneficial effect.   "
216259|NCT00674635|"     This is a randomized, double-blinded, placebo-controlled adaptive, dose finding study to     investigate the safety, tolerability, PK, PD and efficacy of single and repeat intravenous     infusions of GSK315243A in patients with active rheumatoid arthritis. The study is divided     into 2 parts: Part A is an adaptive, dose finding phase which will provide safety,     tolerability, PK and PD on single intravenous infusions. Part B is a repeat dose phase which     will provide safety, tolerability, PK, PD and efficacy following repeat intravenous infusions     of a selected dose level.   "
216273|NCT00674817|"     GSK961081 is a potent dual pharmacophore that demonstrates both antimuscarinic and     beta-agonist pharmacology in preclinical studies, both pharmacologies being of long duration.     If reproduced in man, GSK961081 has the potential to deliver a medicine that can be given     once daily. The bronchodilatation after inhalation of single doses of GSK961081 alone and in     the presence of the short acting beta agonist salbutamol and the short acting muscarinic     antagonist, ipratropium bromide will be measured in this study. Any residual     bronchodilatation post-inhalation of GSK961081 and demonstrated by addition of salbutamol or     ipratropium bromide may provide an indirect assessment of the beta-agonist and antimuscarinic     components of GSK961081   "
216304|NCT00675220|"     This study is conducted in Asia. The aim of this observational study is to collect efficacy     and safety data in diabetic patients with acute hyperglycemia using NovoRapid™ FlexPen™ as     per normal clinical practice.   "
216305|NCT00681421|"     The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201     restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.   "
216260|NCT00674648|"     The purpose of this study is to test the safety of a transfusion of specialized white cells     from your transplant donor's blood, called T-cells, that have been grown and immunized     against the CMV virus in the test tube. If the transplant donor is immune to CMV (ie: the     donor has antibody to CMV in the blood), the T-cells will be selected and grown from the     blood of the transplant donor. However, if the transplant donor is not immune to CMV, or if     T-cells from the donor are not readily available, CMV-immune T-cells grown from the blood of     another normal donor who is partially matched to the patients tissue type can be used. The     transplant physician will explain which of these treatments is available to the patient.      This trial is called a phase I trial because phase I trials are designed to test the safety     of different doses of an experimental treatment. We want to find out what effects, good     and/or bad, a dose/doses of these immune T-cells will have on the patient and on the CMV     infection.      Specifically, we wish to test CMV immune T-cells grown from your blood using a new method     developed at our center. In this method, fragments of an important CMV protein, called     CMVpp65, are chemically synthesized and then used to immunize T-cells in the test tube.   "
216261|NCT00674661|"     Prospective, randomized multicenter study to determine the safety and effectiveness of     performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with     ectasia after refractive surgery.   "
216262|NCT00674674|"     1. To find the optimal dose of topotecan that can safely be given directly into the spinal          fluid (called intrathecal administration) of children whose cancer has spread to the          lining of the brain and/or spinal cord.        2. To find out what effects (good and bad) topotecan has when given directly into the          cerebrospinal fluid in children with neoplastic meningitis (cancer that has spread to          the lining of the brain and spinal cord).             -  Cerebrospinal fluid is the fluid that circulates around the brain and spinal cord.        3. To determine if intrathecal topotecan is beneficial to patients.        4. To better understand how topotecan is handled by the body after intrathecal          administration.        5. To evaluate the cerebrospinal fluid for signs (markers) of tumor spread.   "
216263|NCT00674687|"     The purpose of this study is to assess the reproducibility and the effect of gabapentin on     quantitative sensory testing assessments in neuropathic pain subjects.   "
216264|NCT00674700|"     The purpose of this study is to assess the efficacy of two doses of sublingual immunotherapy     (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared     to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage   "
216265|NCT00674713|"     The aim of the study is to investigate if P6 acupuncture made after induction of general     anaesthesia might be effective for the prevention of PONV as ondansetron and if the     acupuncture-ondansetron combination could enhance single therapy efficacy in patients     undergoing laparoscopic cholecystectomy.   "
216266|NCT00674726|"     The investigators are studying prospectively the difference in axilo-rectal temperature in     patients with acute appendicitis and using as a control group patients consulting with acute     gastroenteritis at our emergency unit.   "
216267|NCT00674739|"     The purpose of this study is to determine whether imiquimod creams are effective in treating     external genital warts (EGW). The secondary objective of this study is to provide information     on recurrence of EGW. Additionally the study will also look at any adverse events associated     with the use of the creams.      External genital and perianal warts are caused by the infection of human papillomavirus or     HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like     small flesh-colored, pink, or red growths on or around the external skin of sex organs or     perianal area. The warts may look similar to the small parts of a cauliflower or they may be     very tiny and difficult to see. They often appear in clusters of three or four, and may grow     and spread rapidly. They usually are not painful, although they may cause mild pain,     bleeding, and itching.   "
216268|NCT00674752|"     The purpose of this study is to assess the effect of gabapentin on polysomnographic     assessments in transient insomnia induced by a sleep phase advance.   "
216269|NCT00674765|"     The purpose of this study is to examine the effects of quetiapine in reducing percent heavy     drinking days and increasing percent abstinent days in alcohol dependent patients who are     frequent heavy drinkers.   "
216270|NCT00674778|"     Previous randomised studies showed that radial artery catheterisation for percutaneous     cardiovascular procedures has a superior safety profile than femoral access, however the     confirmation of these benefits in the real world by a large, specific, observational study is     still lacking.      We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular     procedure by designing a prospective registry monitoring a consecutive sample of patients in     a short period of time at nine Roman hospitals reflecting the contemporary state of health     care.   "
216271|NCT00674791|"     This study will evaluate the safety and feasibility of administering a peptide vaccine     consisting of twelve different tumor-rejection antigens to patients with high risk (TxN2-3M0)     or metastatic breast cancer with no evidence of disease following their completion of     systemic therapy. The vaccine is designed to elicit immune responses against twelve different     pathways that are essential to tumor growth, survival and metastasis.   "
216272|NCT00674804|"     This study will investigate how patients are informed of their cancer diagnosis or recurrence     and will explore their experience in learning about the diagnosis. Specifically, it will:        -  Distinguish methods of telling the diagnosis and identify its relationship to the type          of cancer.        -  Determine if the way a patient is informed of their diagnosis is associated with their          level of satisfaction with the method of being informed.        -  Identify who informs the patient of their diagnosis..        -  Determine patient satisfaction with their diagnostic consult.        -  Identify indicators of satisfaction with the diagnostic consultation.      Patients 18 years of age or older who are enrolled in or being screened for enrollment in a     phase I, II or III clinical trial in the National Cancer Institute's Medical Oncology,     Metabolism, Surgery or Neuro-Oncology branch may be eligible for this study.      Participants complete a 15-minute questionnaire that includes questions related to the how     they were informed of their cancer diagnosis.   "
216306|NCT00681434|"     This randomized, single-blind study compares the effectiveness of bilateral training to     unilateral training for individuals with moderate hemiparesis. We hypothesize that bilateral     training will be superior to unilateral in the proximal extremity but not the distal one.   "
216274|NCT00674830|"     The main goal of this population-based study is to assess the efficacy of two forms of     cognitive-behavioral therapy (CBT) to treat various levels of insomnia symptoms in women with     breast cancer: a professionally administered form and a patient self-administered form. It is     hypothesized that the two treatment conditions will be associated with significantly greater     improvements in sleep, psychological distress, fatigue, cognitive functioning, and quality of     life, relative to the control condition (i.e., usual care). It is also hypothesized that the     magnitude of effect sizes obtained in association with treatment at each time assessment will     be greater for the professionally administered treatment than the self-administered     treatment.   "
216275|NCT00674843|"     The muscular dystrophies (MD) are a group of more than 30 neuromuscular disorders that are     characterized by progressive skeletal muscle weakness, defects in muscle proteins and the     death of muscle cells and tissue. This study will investigate the use of far infrared     radiation for managing muscular dystrophies.   "
216276|NCT00674856|"     To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal     function   "
216277|NCT00674869|"     This randomized clinical trial is aimed at testing the efficacy of pit and fissure sealants,     in a current environmental context different from that of the seventies and eighties. It has     a split mouth design. 4OO subjects are included and the duration of follow up is 2 years.   "
216278|NCT00674882|"     This protocol allows for ongoing data collection to assess the long-term clinical and     psychosocial outcomes of pediatric patients who have received a hematopoietic stem cell     transplant at St. Jude Children's Research Hospital.   "
216279|NCT00674895|"     Parkinson's disease (PD) is a degenerative disorder of the central nervous system that often     impairs the sufferer's motor skills and speech. This study will investigate the use of far     infrared radiation to manage, control and treat PD.   "
216280|NCT00674908|"     The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence     of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib     combination Vaccines) with single sequence of Shan 5 in infants.   "
216281|NCT00674921|"     According to the national guidelines in Uganda and to the World Health Organization     guidelines, HIV-infected patients should receive cotrimoxazole prophylaxis indefinitely.     There are, however, concerns regarding the indefinite application of cotrimoxazole     prophylaxis among patients immunologically stabilized on HAART (e.g. high pill burden,     drug-drug interactions, toxicity and poor adherence because of treatment fatigue). To date no     empirical evidence is available regarding the safety and optimal timing for the cessation of     cotrimoxazole prophylaxis among HAART patients who successfully restored immunological     competence.      Research question: Does morbidity significantly differ between continuation (orthodox) and     cessation (experimental) of cotrimoxazole prophylaxis among immuno-competent patients stable     HAART in the resource-limited setting of Uganda?   "
216793|NCT00688402|"     The purpose of the study is to compare different formulations of AZD3355 in regard to     possible adverse events such as sensations of numbness, tinglings and heat in the skin.   "
216284|NCT00674960|"     Pick's disease, also known as Pick disease,or FTD is a rare fronto-temporal neurodegenerative     disease. This study will investigate the use of far infrared radiation for the control,     management and treatment of Pick's disease.   "
216285|NCT00674973|"     This study is designed to identify biomarkers which may predict improvement in progression     free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who     failed one prior regimen of standard chemotherapy or who are deemed unsuitable for     chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient     population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po     daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study     treatment is until disease progression, and the target sample size is 100-500 individuals.   "
216286|NCT00674986|"     This randomized, parallel group study will determine whether the use of episodic, intensive     glucose monitoring via the Accu-Chek 360 view blood glucose analysis system has a positive     effect on overall glycemic control. Patients will be randomized into either the 'usual care'     group, or the 'interventional group' supplemented with the Accu-Chek 360 view blood glucose     analysis system. The effect of each treatment regimen on glycemic control will be assessed by     measurement of change in baseline HbA1c values at 12 months. The anticipated time on study     treatment is 1 year, and the target sample size is 504 individuals.   "
216287|NCT00674999|"     To determine if Amnion, used on partial thickness burn injuries would provide an improvement     in rate of healing, pain control and scarring as compared to standard medical treatments.   "
216288|NCT00675012|"     The main objective of the trial is to document the safety of NGR-hTNF administered at low and     high doses in combination with a standard oxaliplatin based regimen in patients with     metastatic colorectal cancer not amenable to any clinical improvement by current standard     treatments   "
216289|NCT00675025|"     The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in     children with Down syndrome who have finished the preceding 10-week, double-blind study of     donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic     visit.   "
216301|NCT00675181|"     Does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the     vasospastic syndrome (VS)?      The main questions are:      Do women with VS exhibit...        -  a different basal metabolic rate        -  a reduced choroidal blood flow        -  a reduced increase of oxygen consumption after intake of ice-water        -  a different oxygen consumption after melatonin intake        -  a different choroidal blood flow after melatonin intake        -  a different oxygen consumption after melatonin intake and after intake of ice-water….?   "
216302|NCT00675194|"     The purpose of this study is to determine which Arm (capecitabine + irinotecan versus     capecitabine + cisplatin) shows higher response rates in the treatment of advanced     gastric-oesophagal cancer      Furthermore, comparison of progression-free survival, 1-year survival, Quality of Life and     safety   "
216290|NCT00675038|"     Many hematological disorders are treated by giving red blood cells. Over a long period of     time iron from the red blood cell will accumulate in the tissues of the heart, liver, and     endocrine glands. This condition is referred to as iron overload and may become life     threatening due to the effects of the iron on these tissues. The normal method for evaluation     of iron overload is a liver biopsy. This procedure is invasive and has potential risks, such     as bleeding and infection.      It is very desirable to establish a method for assessing iron overload which is not invasive.     New magnet resonance imaging (MRI) relaxation techniques (T2*MRI) can be used to indirectly     assess the liver iron content and iron in the heart. Results of T2*MRIs show excellent     correlation with liver iron content and heart function. The use of this method of assessment     will minimize the risk and inconvenience of liver biopsy and possibly allow more frequent     evaluations for iron overload, thus better treatment for these patients.      Participants in this study will undergo both liver biopsy for liver iron content and T2* MRI     of the liver and the heart. Results from the procedures performed in this study will be     compared, with the end result being the possible elimination of invasive procedures to     diagnose iron overload.   "
216291|NCT00675051|"     Pulmonary hypertension is a progressive and life threatening condition. It is characterized     by severe remodeling of the pulmonary vessel wall, obstructive plexiform lesions, multi-focal     thrombosis, and enhanced vasoconstriction. All of these characteristics contribute to     increased pulmonary vascular resistance.      Circulating endothelial microparticles (EMPs) play an integral role in the pathogenesis and     perpetuation of pulmonary hypertension. Levels of EMPs are considered a reliable biological     parameter of endothelial injury.      We propose to assess the evolution of both circulating and pulmonary venous EMPs in patients     with PH. Assessments will be made before and after initiation of Endothelin-1 (ET-1) Receptor     blocker therapy, and correlated to their patterns with the changes in mean PAP, the 6 Minutes     Walking Distance test, and circulating Endothelin-1 values. Measurements of the endothelial     microparticle circulating levels (assessed by flow cytometry methods) will be made before, 1     month and 3 months after initiation of therapy.   "
216292|NCT00675064|"     This study will examine safety of single doses of GSK369796 in healthy subjects, along with     some test to examine how quickly GSK369796 gets in your blood, and how long it takes your     body to get rid of it.   "
216293|NCT00675077|"     Huntington's disease (HD) is a fatal disease with profound neurological and behavioral     features. HD is typically characterized by uncontrollable movements and psychological     disturbances.      This study will investigate the use of far infrared radiation for control, management and     treatment of HD.   "
216294|NCT00675090|"     This is a safety and tolerability study to investigate the effect of GSK239512 on mild to     moderate Alzheimers disease patients. The dose of GSK239512 will be titrated to reach the     most well tolerated dose in the patients.   "
216295|NCT00675103|"     The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24     week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase     i.v. was at least one year before study entry.      This study is limited to four study centers in the US.   "
216296|NCT00675116|"     This is a study to evaluate the safety, tolerability and pharmacokinetics of GW823296     following 28 days, once-daily repeat oral doses.   "
216912|NCT00690339|"     Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing     primary augmentation, primary reconstruction, or revision of existing breast implants.   "
216297|NCT00675129|"     The purpose of the study is to evaluate the efficiency of dialectical behavior therapy (DBT)     in treatment of adolescents with deliberate self harm compared to Enhanced Usual Care (EUC).     Eighty patients in the age of 12-18 yrs old will be included in the study. The main inclusion     criterion is repetitive deliberate self-harm. The patients will receive 16 weeks treatment in     outpatient clinics in Oslo, after having been randomized to DBT or EUC. They will be assessed     on five different time-points: baseline (before starting treatment), 6 weeks (after start of     treatment), 12 weeks, 16 weeks and 68 weeks.      The main study hypothesis is:        -  DBT will be significantly more effective in treatment of self-harm behavior, as          measured/indicated by reduction in number of self-harm episodes with or without intent          to die, as well as reduction of number of emergency room visits.        -  It is also hypothesized that DBT will significantly reduce the level of suicidal          ideation and depressive symptoms compared to EUC.   "
216298|NCT00675142|"     The timing of IUI following ovulation induction has been the subject of many studies and a     consensus has developed that a single insemination approximately thirty-six hours after     ovulation induction is sufficien. The introduction of GnRH antagonists preventing a premature     LH surge and early ovulation has added a new dimension to fertility treatment. It allows     greater accuracy in predicting the timing of ovulation and has been shown to be at least as     effective, if not more effective, as ovarian stimulation without antagonists. We hypothesize     that by utilizing GnRH antagonists we can increase pregnancy rates during IUI by timing the     IUI as close as possible to the moment of ovulation guaranteeing the highest and freshest     concentration of motile spermatozoa in the fallopian tube at the time the oocyte is released     from the ovary. We therefore propose a randomized open three arm prospective trial utilizing     superovulation with GnRH antagonists whereby the IUI is timed to take place 36, 42 or 48     hours after ovulation induction.   "
216299|NCT00675155|"     A stroke is a sudden loss of brain function. It is caused by the interruption of flow of     blood to the brain (ischemic stroke) or the rupture of blood vessels in the brain     (hemorrhagic stroke). This study will investigate the use of far infrared radiation for     stroke rehabilitation.   "
216300|NCT00675168|"     The prognosis of lung cancer depends much on the stage of the disease at the time of     diagnosis. Only 16 % of lung cancer can be offered curative intended surgery. Chest x-ray is     the gate-keeper in lung cancer diagnosis, but it has a miss rate of 20-60 %. A false negative     chest x-ray often causes prolonged delay in diagnosis - often months.      Recently a 48 hour diagnosis guaranty has been implemented, which helps accelerate the     system delay (delay from referral to diagnosis). But chest x-ray is still the gate-keeper; if     the chest x-ray is negative further examination ceases.      PET/CT has a higher sensitivity (96 %), than chest x-ray. In the latter years only little     improvement in the survival rate of lung cancer has been made. Screening studies is currently     been performed, but it's time for innovative thinking. PET/CT has established its place in     the staging of lung cancer. But studies like this may help to place PET/CT in the chain of     examination making it more cost-beneficial.      The overall aim of this study is to improve patient course with earlier diagnosis of lung     cancer.   "
216307|NCT00681447|"     1. To demonstrate clinically significant improvements in patients undergoing lumbar          interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome          measures of pain and function.        2. To evaluate and compare the adverse event profile in all patients.   "
216308|NCT00681460|"     Gestational diabetes (GDM) is a condition that manifests as high blood sugar levels     (hyperglycemia) during pregnancy in previously healthy women. It develops as a result of     increased maternal body's resistance to insulin - a major hormone that allows for utilisation     of glucose (sugar taken in with food) within cells. It was found out that GDM occurs more     frequently in overweight women but also in women with a history of certain conditions such as     polycystic ovary syndrome (PCOS). Usually, GDM disappears after pregnancy is completed but it     is associated with some serious hazards for women and her unborn child, if untreated     properly. Diet is a first-choice treatment but sometimes insulin therapy must be initiated if     keeping a diet alone is not enough to maintain blood sugar within recommended values. Insulin     therapy is effective but it requires several injections during each day and insulin is a     strong acting hypoglycemic agent that may induce rapid falls in blood sugar, also dangerous     for mother and unborn child.      In the investigators study, the investigators would like to investigate if metformin that is     a commonly used hypoglycemic drug can be effectively used for GDM treatment. Metformin has     been used successfully for a long time to treat type 2 diabetes mellitus and PCOS and,     according to current data, it is not dangerous neither for mother nor for baby when used     during gestation.   "
216309|NCT00681473|"     In this research study, we are looking to study the side effects from the use of proton     radiation in treating people with low-grade gliomas that are recommended radiation treatment.     We expect response of the tumors to be the same with proton radiation as compared to standard     3D conformal radiation therapy, but also expect less side effects from radiation.   "
216310|NCT00681486|"     The study is designed to evaluate whether ghrelin treatment can improve appetite in weight     losing cancer patients.   "
216311|NCT00681499|"     Patients with malignant diseases are increasingly receiving more extensive hepatic     resections, with im-proved preoperative and postoperative care leading to a reduced     postoperative morbidity and mortality. In this setting, postoperative quality of life may     become as important as overall patient survival. In this study we will be investigating the     effect of the initial disease for which hepatic resection was carried out on short- and     long-term quality of life.   "
216312|NCT00681512|"     The purpose of this study is to determine how berries affect cancer tumors in patients with     non-small cell lung cancer.   "
216313|NCT00681525|"     The objective of this study is to evaluate the potential PK interaction between ABT-335,     atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.   "
216314|NCT00681538|"     The purpose of this study is to determine whether Sativex® versus Placebo is effective in the     relief of symptoms of spasticity in subjects with multiple sclerosis, who have been     identified as having a capacity to respond to Sativex.   "
216342|NCT00682227|"     The purpose of this study is to evaluate the safety and immunological monitoring for peptide     vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or     metastatic esophageal squamous cell carcinoma   "
216315|NCT00681551|"     To verify the number of metastatic brain tumors detected in contrast-enhanced MRI, which is     the primary variable, increases after an additional dose of Magnevist (SH L 451A) comparing     images after an initial dose (0.1 mmol/kg) with those after an additional dose (0.1 mmol/kg,     a total dose of 0.2 mmol/kg) intra-individually in patients with metastatic brain tumors.     Safety was also to be assessed.   "
216316|NCT00681564|"     The purpose of this study is to determine the effect of periodontal therapy on endothelial     function and other biomarkers of cardiovascular disease   "
216317|NCT00681577|"     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402     restricted epitope peptides URLC10, KOC1, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.   "
216318|NCT00681590|"     This study will evaluate the safety over 6 months of two different doses of vitamin D     (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation     with vitamin D improves physical performance.   "
216319|NCT00681603|"     1. Purpose:Our animal study demonstrated the effectiveness of subconjunctival injection of          bevacizumab in the inhibition of corneal neovasculization formation. The purpose of this          human interventional study is to report the treatment outcome of subconjunctival          injection of bevacizumab in patients with corneal neovascularization.        2. Material and methods: We enrolled 13 patients with unilateral or bilateral clinically          significant corneal neovascularization during Aug. 2007 to Jan. 2008. Subconjunctival          injection of bevacizumab once per month for at most 7 times was performed according to          clinical response.        3. Main outcome measurements: resolution of corneal neovascularization, reduction of lipid          infiltrate, improved visual acuity.   "
216320|NCT00681616|"     An investigation of a new catheter and pressure monitor system that may help to prevent a     complication called compartment syndrome from developing in an injured leg. Compartment     syndrome occurs when too much fluid builds up in the muscles of the injured leg. This causes     a lot of swelling and increases pressures within the leg that can cause permanent damage     muscles and nerves in the leg.   "
216321|NCT00681629|"     The purpose of the study is to investigate the well-being of schizophrenic patients treated     with quetiapine XR combined with participation in the integrated care program compared to a     treatment with quetiapine XR alone over a period of 18 month   "
216322|NCT00681642|"     Human serum eye drops have been successfully used in the treatment of severe ocular surface     disorders and the enhancement of corneal wound healing. Umbilical cord serum is also proven     to be effective in treatment of dry eye and persistent corneal epithelial defects. However,     there are limited studies comparing the corneal epithelial wound healing promoting effects     between these two blood derived products. The purpose of this study is to test the corneal     epithelial wound healing promoting effects between auto serum and human cord blood serum.     Primary cultured bovine corneal epithelial cells were used as the model to investigate wound     healing, cell proliferation and migration by means of scratch corneal wound healing assay     evaluation, MTS assay and Boyden chamber migration assay in response to human serum and     umbilical cord serum. The concentrations of EGF, TGF-β1, and fibronectin were also compared     between human serum and umbilical cord serum with ELISA kits.   "
216458|NCT00683800|"     The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate     (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor     Symptoms (VMS) in menopausal women.   "
216323|NCT00681655|"     This study will study the presence of a particular form of a gene, GABRA2, to characterize     functional responses of the human brain to alcohol administration and will evaluate that     relationship in the context of factors known to increase the risk for future alcoholism.   "
216324|NCT00681668|"     The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female     patients with postpartum depressive disorder with psychotic symptoms   "
216325|NCT00681681|"     The purposes of this study are to quantify and compare vascular function in men and women,     and to determine the effect of age, race-ethnicity, cardiovascular risk factors, biological     markers and hormonal markers on vascular measures to establish gender-specific models.   "
216326|NCT00681694|"     The purpose of this research study is to assess outcomes of treatment for early prostate     cancer. Current treatments for early (non-metastatic) cancer may cause long-term impairments     in the patients quality of life. In this study we will compare the outcomes of patients     treated with two alternative brachytherapy (seed implants) techniques using a series of     questionnaires.   "
216327|NCT00681707|"     This study will address the treatment rate and control rate of hypertension, treatment     pattern and factors that affect BP control by examining retrospective medical records of     hypertension patients recovering from stroke, among outpatients coming to the Neurology     Department in 10 university hospitals nationwide.   "
216328|NCT00681720|"     The study is carried out in order to determine the relationship between the dose of AZD7325     and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to     the GABAA receptors.   "
216329|NCT00681733|"     1. To assess the metabolic factors in lean and obese patients with NASH.        2. To compare the efficacy of pentoxifylline versus pioglitazone on the metabolic profile          and liver histology of NASH patients.   "
216330|NCT00681746|"     The study is carried out in order to determine the relationship between the dose of AZD6280     and the blood concentration of AZD6280, and to investigate to which extent AZD6280 binds to     GABAA receptors   "
216331|NCT00682084|"     The purpose of this study is to investigate the effect og chronic elevated levels of cortisol     on metabolism and insulin sensitivity.   "
216332|NCT00682097|"     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of     multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes     mellitus. Successive cohorts of patients will be randomized to receive either active drug, at     escalating doses, or placebo. The anticipated time on study treatment is <3 months, and the     target sample size is <100 individuals.   "
216333|NCT00682110|"     The purpose of the study is to determine if the less invasive monitors are as reliable for     measuring heart function in patients undergoing liver transplantation as the more invasive     pulmonary artery.   "
221721|NCT00753025|"     The purpose of this study is to determine whether autologous bone marrow derived cells and     isolated CD133+ fraction are effective in the treatment limb ischemia   "
216334|NCT00682123|"     There is compelling evidence that some dietary supplements consumed by the general population     are manufactured and stored under conditions that lead to contamination of the end product     with small amounts of extraneous materials. In most cases, this is harmless, but for athletes     liable to drug testing as a consequence of their participation in sport, the potential     consequences of even trivial amounts of a prohibited substance may be catastrophic. Quality     control procedures for pharmaceutical products normally specify the absence of contaminants     at a level of more than 0.1%, ie 1mg/g. However, in the case of an anabolic steroid such as     nandrolone, the amount that will cause a positive test has been estimated to be about 1-3µg     (Geyer et al, 2004). In the case of a supplement that is taken in high doses (20-30 g/d),     such as for example creatine, this means that a contamination level of something closer to     0.00001% (ie 1µg/g) may cause a positive test. This work have been supported by recent     findings from our laboratory (Judkins et al, 2006). These data demonstrate that as little as     10μg of 19-noradrostenedione (19-NorAD) added to a creatine supplement resulted in a positive     doping test in all volunteers testing. This is one thousand times less that the purity level     specified for pharmaceutical agents and at this level, these contaminants are without any     pharmacological action.      Proposals are under development to regulate the sale of dietary supplements for use by     athletes to avoid accidental doping positives as a result of ingestion of contaminated     supplements. This requires a knowledge of the amounts of contaminant that is likely to cause     problems. The aim of the present study was to examine the urinary excretion pattern of     nandrolone metabolites following 1µg, 2.5µg and 5µg doses of 19-norandrostendione in both     male and female subjects. The quantity of 19-norandrostenedione administered in this study is     representative of the amount previously reported as an undeclared contaminant in some dietary     supplements. Given the speculation surrounding positive doping cases being attributed to     ingestion of sports supplements contaminated with pro-hormones, this presents an important     consideration for both athletes and doping agencies, as well as supplement manufacturers.   "
216335|NCT00682136|"     The aim of the study is to establish the efficacy of local anaesthetic TAP (transversus     abdominis plane) blocks in providing pain relief in the first 24hrs following open or     laparoscopic elective abdominal colorectal operations.      TAP blocks involve the injection of local aesthetic (ropivicaine) into the transversus     abdominis plane in the abdominal wall. This injection takes place after induction of     anaesthesia, but before the commencement of surgery. TAP blocks have been proposed as a     potential safer alternative to epidural anaesthesia. The blocks have been extensively used in     the Hunter New England system over the last 18 months. As yet there is no clear evidence for     there efficacy, hence the need for this trial.      This trial would establish the efficacy of this practice. If the technique proves effective     it could be widely used and provide a simpler method of managing post operative pain.   "
216336|NCT00682149|"     There has been an increase in the prevalance of type 2 diabetes in developed countries in     recent years. The major contributing factors have been genetic predisposition, environmental     factors, and unhealthy eating habits and stress. Adverse effects on cardiovascular and renal     systems after prolonged hyperglycemia bring serious burden to patients, to their families and     to the society.      Oxidative stress has been defined as the imbalance between the production of reactive oxygen     molecules and antioxidant protective molecules. It has been claimed that oxidative stress     that the organism is exposed to and disturbance in anti-oxidant mechanisms have been     important in the initiation of diabetes and its complications. Malondialdehyde is the final     product of lipid peroxidation and it is an aldehyde as well. It has been accepted that     malondialdehyde has been a biomarker in measuring oxidative stress.      Type 2 diabetic people who are between 40 -65 years of age will be the subjects of our study.     The levels of fasting glucose, HbA1c, LDL, triglyceride, AST and ALT and also     malondialdehyte, hydrogen peroxide and oxidative stress will be determined in patients blood     after making them consume a 1500 calory standard diet for 2 weeks, The patients will be     randomly divided into two grouos at the end of the two weeks. Group 1 will take placebo in     addition to the diet, Group 2 will receive polyphenol containing capsules with pomegranate     extract (500 mg), green tea extract (300 mg) and a little bit of (60 mg) vitamin C for three     months. At the end of three months the measurement of biochemical parameters will be     repeated.      Patients with cardiac, renal, liver disease and smokers will be excluded from the study.      Patients in both groups will have a diet rich in vegetables, three servings of fruit, maximum     three slices of bread with a total calory of 1500.      In addition to these, both groups will have a weekly aerobic exercise regimen of 150 minutes     conducted after breakfast.      The biochemical results of the two groups will be compared at the end of the experiment and     they will be statistically evaluated.   "
216459|NCT00683813|"     Cardiac rehabilitation programs (CRP) are a proven treatment for those with ischemic heart     disease (IHD). These programs have been demonstrated to improve adherence to regular physical     activity, a healthy diet and smoking cessation, as well as modify risk factors for IHD such     as hypercholesterolemia, hypertension, obesity and type 2 diabetes. In addition, CRP are cost     effective and can result in a 25% reduction in reoccurrence of mortality. Despite the known     benefits of CRP, as little as 10% to 25% of eligible patients attend these programs. One of     the main barriers to attendance is proximity to a CRP, as the majority of these programs are     limited to hospitals in large urban areas. However, cardiovascular diseases do not     discriminate by geography, resulting in a geographic inequity of care for patients living in     rural, remote and smaller urban/sub-urban centres. Currently there are no CRP specifically     designed for patients in rural and remote areas. The use of the Internet may present itself     as a viable alternative. We have recently completed a pilot study of a virtual CRP (vCRP)     that demonstrated significant improvements in exercise capacity and risk factors. This     investigation will study the vCRP in a group of IHD patients who do not have access to     hospital-based CRP.      Hypotheses A. Participation in a 4 month Internet-based cardiac rehabilitation program will     result in significant improvements in exercise capacity compared to usual care, in patients     with diagnosed IHD.      B. Participation in a 4 month Internet-based cardiac rehabilitation program will result in     significant improvements in exercise capacity after one year compared to usual care, in     patients with diagnosed IHD.      Study Population Men and women over 18 years will be identified from consecutive in-patients     of the British Columbia Provincial Heart Centre at St. Paul's Hospital in Vancouver who     reside in either the Northern Interior or Coast Garibaldi health areas. Patients will be     eligible if they have IHD, Internet access, no previous experience with cardiac     rehabilitation and no physical limitations to exercise. A total of 74 patients (37 per group)     will be recruited and randomized to either usual care, or a 4 month 'virtual' cardiac     rehabilitation program delivered via the Internet.      Usual Care Group Patients randomized to usual care will be provided with simple guidelines     for safe exercising and healthy eating habits, and return to the care of their primary care     physician. Patients will return at 4 and 16 months later for outcome assessment. There will     be no contact between the study personnel and usual care patients for the duration of the     study, nor will there be any attempt to control the level of patient care.      Intervention The vCRP has been developed to mimic hospital-based CRP and includes online     intake forms, one-on-one chat sessions with vCRP nurse, dietitian and exercise specialist,     data collection (exercise heart rate, blood pressure, glucose- if diabetic), peer-support     group chat sessions, ask-an-expert chat sessions, education, progress reports and online     resources. Upon randomization to the intervention, patients will receive access to the     website, a heart rate monitor and a blood pressure monitor and trained in their use. The     heart rate monitors allow for exercise heart rate data to be stored and downloaded to their     home computer and then uploaded to the vCRP webserver. The exercise data will be reviewed     weekly. A letter to the patient's primary care physician will be sent to outline the vCRP     intervention, the treatment algorithms to be used and indicate under what circumstances the     vCRP nurse and/or patient may contact them with regards to their management. Patients will     receive one-on-one counselling by the nurse, dietitian and exercise specialist via chat     sessions at 3 to 4 week intervals. After the 4 month intervention, patients will be     discharged into the care of their primary care physician.      Outcomes Participants will be assessed at baseline, 4 and 16 months for risk factors and     lifestyle behaviours. The primary outcomes will be the change in exercise capacity as between     the two groups from baseline to 4 months, and from baseline to 16 months. Exercise capacity     will be assessed as total time on a symptom-limited exercise stress test.   "
255784|NCT02619877|"     This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU     in patients with Diabetic Foot Ulcer, compared to standard therapy.   "
216337|NCT00682162|"     Chronic rhinitis without an allergic or infectious aetiology (vasomotor rhinitis) is a common     disease for which there are only poor therapeutic treatment options. The current placebo     controlled partially double blinded pilot study evaluated the effects of acupuncture on the     symptoms of vasomotor rhinitis.   "
216338|NCT00682175|"     To determine the association of both neurohormonal and hemodynamic alterations associated     with metabolic abnormalities in acute heart failure syndrome.   "
216339|NCT00682188|"     Overweight in adolescents has nearly tripled in the past two decades and has serious physical     and psychosocial consequences, both during adolescence and into adulthood. School nurses have     tremendous potential to prevent and treat overweight in this population, as over 95% of     adolescents have contact with the school health system each year and school nurses have the     credibility and skills to provide guidance regarding weight, diet and physical activity. The     goals of the proposed exploratory study are to adapt an innovative, theory-based school     nurse-delivered counseling intervention model used effectively for smoking cessation for the     treatment of adolescent overweight, and test its feasibility and potential efficacy in     reducing BMI, improving diet, increasing physical activity and decreasing sedentary behavior.     If the results of this exploratory study prove promising, the efficacy of the intervention     will be evaluated in a large scale randomized controlled trial.   "
216340|NCT00682201|"     Prospective, observational study of the changes in hemodynamic variables such as blood     pressure, cardiac output, systemic vascular resistance, and of changes in respiratory     variables such as vital capacity, and functional residual volume.A cohort study of 100     healthy pregnant women tested with non-invasive methods during pregnancy and 6 months after     delivery.   "
216341|NCT00682214|"     Hypovitaminosis D is common in Asian Indians despite plenty of sunshine and relates to their     skin pigmentation and poor sunshine exposure. Serum 25(OH)D levels are <20 ng /ml in up to     90% of them and therefore, based on the modern cut off, majority of apparently healthy normal     Asian Indians would be classified as vitamin D deficient. Though, several investigators have     highlighted the paradox of hypovitaminosis D in sunny Indian environment, there are only     limited studies which have assessed its functional significance. To date, the significance of     low serum 25(OH)D in them have been analyzed in terms of its inverse relationship with serum     parathyroid hormone levels and variable association with reduced bone mineral content at hip     and spine on DXA. Recently we have shown impairment in the absorption of intestinal calcium     in 25(OH)D and its reversal after eight weeks of cholecalciferol supplementation. Present     study is being taken to further understand the functional significance of 25(OH)D in terms of     its effect on Skeletal muscle strength including its energy metabolism, bone mineral     homeostasis and Th1/Th2 cytokines expression in Asian Indians with chronic biochemical     hypovitaminosis D   "
216343|NCT00682240|"     Imaging of retinal morphological changes with time secondary to laser treatment as assessed     with high definition optical coherence tomography (OCT). Furthermore changes in retinal     function as an effect of treatment will be documented by visual acuity testing using ETDRS     charts and microperimetry. The change in vascular leakage will be assessed by performing     fluorescein angiography, flare counts will be performed monthly.   "
216344|NCT00682253|"     A new imaging modality combining CT and tomographic bone scintigraphy (SPECT/CT) has enabled     the combination of functional and anatomical imaging. Its use in cancer patients has not yet     been evaluated or validated against a relative gold stand or clinical follow up. The purposes     of this study are: 1: to validate the use of conventional planar bone scintigraphy and SPECT     combined with low-dose or diagnostic CT and compare this to 3 Tesla MRI and clinical follow     up. 2: to compare the specificity of low-dose and diagnostic CT, respectively, combined with     bone SPECT. 3: to construct an algorithm for optimal evaluation of disease dissemination in     breast cancer patients   "
216345|NCT00682266|"     The aim of the present study was to determine the effects of a multidisciplinary approach and     intensity-controlled interval training on cardiovascular risk factors in overweight     adolescents   "
216346|NCT00682279|"     This is an open-label, Phase I study of oral topotecan administered in combination with     lapatinib in subjects with advanced solid tumors. This Phase I study will evaluate the     safety, tolerability, and pharmacokinetics of oral topotecan administered in combination with     lapatinib. This study will be conducted in two parts. Part 1 of the study will investigate     the impact of lapatinib on the bioavailability of oral topotecan (bioavailability phase) and     Part 2 of the study will consist of dose finding to determine the maximum-tolerated dose     (MTD) regimen of the combination (dose escalation phase). In Part 2 of the study, the dose of     oral topotecan will be escalated while lapatinib will be given initially as fixed doses. The     primary objective of the study is to determine the MTD regimen of oral topotecan administered     for five-consecutive days every 21 days in combination with daily lapatinib in subjects with     advanced solid tumors.   "
216347|NCT00682292|"     To compare renal allograft rejection rates during the first year among high-immunological     risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.   "
216348|NCT00682305|"     The present study is a multicenter, prospective phase II-study investigating the combination     of treosulfan, etoposide, and cyclophosphamide as conditioning regimen for patients with     acute lymphoblastic leukemia who are not eligible for a TBI-containing regimen.   "
216374|NCT00682669|"     Asthma is one of the four most common chronic disorders in adults, affecting 14 million     adults in the United States and costing an estimated 7.9 billion dollars in medical care and     5.3 billion dollars in lost work or school. About 40% of asthmatics report using some form of     complementary and alternative medicine approach to help reduce their asthma symptoms, but     there is little evidence for their effectiveness. Mindfulness-based stress reduction (MBSR)     is a group based program shown to reduce medical symptoms and improve quality of life for     patients with many different chronic diseases. The goals of the proposed randomized     controlled trial are to collect preliminary data on the effect of MBSR on quality of life,     symptoms, and lung function in mild and moderate-severity asthmatics and to refine     recruitment and data collection procedures for a future, larger clinical trial.   "
216349|NCT00682318|"     The American Heart Association and the American College of Cardiology (AHA/ACC) recently     encouraged increased consumption of omega-3 fatty acids in the form of fish or capsule form     (1 g/day) for risk reduction and stated that for treatment of elevated triglycerides,     higher doses are usually necessary for risk reduction (Smith SC et al. Circulation     2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy     of the omega-3 treatment with data derived from single randomized trials or non-randomized     studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to     elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but     even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama     2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective     effects of omega-3 FAs.      The objective of the clinical study is to study the effects of fish oil on blood and urinary     markers of inflammation and cell stress. By using different permutations of high-dose     supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish     doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3     fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell     stress.   "
216350|NCT00682344|"     Levobupivacaïne (Chirocaine®) is a new local anaesthetic recently marketed in France. The     goal of this prospective work is to study the pharmacokinetic aspect of this drug after     injection around the sciatic nerve (subgluteal way).   "
216351|NCT00682357|"     Oral and nasal steroids may enhance osteoporosis by suppressing bone formation.     Intra-articular steroids may also suppress bone formation, however, the duration or     relationship to a steroid dose has not been established. It is hypothesized that     intra-articular steroids suppress bone formation transiently, returning to pretreatment     levels within four weeks in subjects with osteoarthritis.   "
216352|NCT00682370|"     Heme oxygenase 1 (HO-1) serves as a protective gene. It has been shown that one factor     modulating HO-1 activity is a genetic variation in the HO-1 gene (functional GT length     polymorphism in the promotor region). Heme arginate is a strong inducer of HO-1 as shown in     several animal experimental studies. The aim of this clinical trial is to evaluate the HO-1     stimulation of heme arginate in healthy humans.   "
216353|NCT00682383|"     To determine the safety and efficacy of administering filgrastim with concurrent     chemoradiotherapy and the potential benefit of administering pegfilgrastim with consolidation     chemotherapy in patients with unresectable locally advanced NSCLC patients.   "
216354|NCT00682409|"     Classical imaging techniques are inaccurate to detect residual cholesteatoma. The aim of our     study is to evaluate the value of diffusion-weighted MR imaging and delayed contrast enhanced     T1 weighted spin-echo sequences in the detection of residual cholesteatoma in children, in a     large serie of surgically verified cases.   "
216355|NCT00682422|"     The aim of this qualitative study is to explore parental and child perceptions of     participating in a family-based behavioral intervention targeting healthy behaviors.   "
216356|NCT00682435|"     We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone     followed by an additional 1mg. Eligible patients will be given 1 mg IV hydromorphone. At 15     minutes, these patients will be asked the question, Do you need more pain medication? Those     that answer yes will receive an additional 1mg IV hydromorphone. Those that answer no     will not receive additional pain medications at that time period (15 minutes). Thus, we wish     to give up to 2 mg IV hydromorphone titrated to patients' pain, which we believe will result     in less incidence of oxygen desaturation.      If our study shows that this regimen is safe, its efficacy can be assessed in future trials.     Positive results of those trials may lead to the use of this regimen to improve pain     management in the emergency department.   "
216357|NCT00682448|"     We hypothesize that metformin co-administered with olanzapine will be well tolerated and     associated with significantly less insulin resistance, weight gain and dyslipidemia as     compared to olanzapine plus placebo.   "
216358|NCT00682461|"     This study is to evaluate the oral tolerability of a nicotine prototype   "
216359|NCT00682474|"     The purpose of this study is to conduct a randomized controlled school-based trial to     evaluate the effectiveness of a four-session school nurse-delivered smoking cessation     intervention in increasing abstinence rates among high school students who smoke.   "
216360|NCT00682487|"     Aim of the study:      To evaluate whether hair cortisol levels are elevated in patients admitted with acute MI     compared to controls.      Study steps:        1. Introduction of the study to the participants and inform consent signing        2. Collection of clinical and demographic data        3. Scalp hair sampling- samples will be sent for laboratory analysis        4. Analysis of the results   "
216361|NCT00682500|"     This study will determine if administration of an suspension of calfactant, a lung     surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome     within 48 hours of requiring mechanical ventilation can decrease the mortality in patients     with lethal disease and shorten the course of respiratory failure in patients with sub-lethal     disease.   "
216362|NCT00682513|"     The purposes of this study are to identify persons with rapid-onset dystonia-parkinsonism     (RDP) or mutations of the RDP gene, document prevalence of the disease, and map its natural     history.   "
216373|NCT00682656|"     The adequate treatment of the American tegumentary leishmaniasis is crucial since the     disease, differently from the caused by the Old World species, is painful and not     self-healing and may lead to the disfiguring mucosal involvement. So far, pentavalent     antimony compounds have been considered the treatment of choice for cutaneous leishmaniasis     (CL), however, these drugs present high frequency of side effects and important disadvantages     as parenteral administration and need for careful renal and cardiac monitoring. Azithromycin     is a macrolide antibiotic, non-expensive, largely commercially available that has shown     in-vitro and in vivo activity against different species of Leishmania.      The main objective of this study is to evaluate the efficacy and safety of oral azithromycin     for the treatment of CL. The efficacy of oral treatment of azithromycin 500 mg/day for 20     days is going to be compared with the standard treatment of intramuscular injections of 20     mg/Kg/day of pentavalent antimonials (Glucantime®) for 20 days in patients with CL from two     endemic regions of Brazil: the metropolitan region of Belo Horizonte and Montes Claros (MG)in     the southeast Brazil and in Corte de Pedras (Bahia), Northeastern Brazil. The patients follow     up lasts for 12 months.   "
216363|NCT00682526|"     Aim: To determine the impact of wireless transmission of prehospital ECGs to a hand-held     computer on time to treatment and myocardial salvage in acute MI patients.      Background: The TIME-1 investigators documented a 27% (109 to 80 minutes) reduction of time     from EMT arrival at the scene to successful primary PCI implementing pre-hospital ECG     transmission to the ED. ECG transmission directly to a physician's cellular phone/PDA through     a wireless modem has only recently become an option. The recently completed TIME-NorthEast     (NE) study tested the Welch Allyn version of this system and the results show a reduction in     time to reperfusion for acute MI patients by 66 minutes (116 to 50).      Methods: This study will involve approximately 20 sites around the country. The study will be     divided into two phases: a consecutive control data collection phase (Phase I) and an     intervention with concurrent control phase (Phase II). Phase II will begin after installation     of Welch Allyn ECG transmission equipment. The primary end-point will be time to reperfusion     and secondary end-points will include myocardial salvage, aborted infarction and hospital     mortality. ECG measurements will be made at a central ECG core lab by a blinded investigator.      Data Analysis: Patient characteristics for the three periods were compared with the     chi-square statistic for categorical variables and one-way analysis of variance for age. The     Wilcoxon rank-sum statistic was used to compare time-to-reperfusion in the pre-study and     study periods as well as in the Group 1 post-study period. Comparisons were performed     separately for EMS and self-transport groups.   "
216364|NCT00682539|"     The purpose of this study is to investigate the change in macular edema and the absolute     change in visual acuity following intravitreal administered injections of Bevacizumab     (Avastin®) or Ranibizumab (Lucentis®) compared with Triamcinolone (Volon A®) in patients with     clinical significant diabetic macular edema.      The investigators monitor the change in macular edema measured with standard optical     coherence tomography (OCT) and the absolute change in visual acuity analyzed by standardized     charts according to the protocol used in the Early Retreatment in Diabetic Retinopathy Study     (ETDRS).   "
216365|NCT00682552|"     Relationship between HPV infection and cervical cancer is well established. Among the HPV     types identified to date, 15 are classified as high risk HPV (HR-HPV). Detection of HR-HPV     has been proposed to optimize cervical cancer screening.   "
216366|NCT00682565|"     This study investigates whether symptom-limited exercise capacity in ischemic cardiomyopathy     patients with angina is deleteriously affected by treatment with CK-1827452.   "
216387|NCT00682838|"     Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of     up to one-fifth of all Veterans. Because of disappointingly low adherence to the     gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute     of Medicine has stated that new adherence strategies are needed that improve the quality of     care, reduce social and economic costs, and help OSA patients live happier, healthier, and     more productive lives through improved clinical management. The combination of a     self-management approach along with emerging wireless technologies has strong potential to     increase treatment adherence and improve outcomes.   "
216367|NCT00682578|"     Malaria is a major public health problem in many provinces of Afghanistan the failure rate of     chloroquine (CQ) and amodiaquine (AQ) treated Plasmodium falciparum(Pf) malaria has risen to     more than 60% overall and as high as 90% in Jalalabad. CQ remains fully effective against P     vivax, and sulphadoxine-pyrimethamine (SP) remains effective against P falciparum (10-15% of     cases fail to cure). The current malaria treatment protocol still continuing CQ for P.vivax     and adopted Artmisinine based combination therapy (ACT) for treating (Pf) malaria, as most     than 50% malaria has being diagnosed clinically, so due to this and other operational reasons     the protocol needs to be simplified.      By comparing 56 day PCR corrected cure rate of DHA-PPQ with the standard treatment regimen as     primary objective and comparing the safety, gametocytecidal effect and parasite clearance     time as secondary objectives, our study titled: Randomized, Open Label, controlled,     non-inferiority clinical trial for comparison of Efficacy & safety, will provide scientific     evidence to lead the simplification and improvement of the standard malaria treatment regimen     in Afghanistan; to adopt a policy of treating both vivax and falciparum malaria with the same     drug regimen.      With a significance level (α) = 0.05 and a power=80%, the calculated sample size is 274 per     study arm. Therefore about1100 patients (274 per study-arm: 548 patients with falciaprum     malaria and 548 patients with vivax malaria) will be recruited in Malaria reference Centers     (MRCs) of three malaria endemic provinces (Nangarhar in the east, Thakhar in the north-east     and Faryab in the north-west of country) after signing written inform consent form, according     the inclusion and exclusion criteria and will be treated as out patients by giving the     randomized drug dose under observation of study team and followed-up daily for 3 days (as     treatment course of either arm is once daily dose for three days) and after than weekly up to     day 56. and the study is planed to conducted in 3 provinces of Afghanistan for approximately     2 years.      Patients will be assessed clinically as well necessary laboratory tests will be performed and     all the bio-medical findings will be recorded in special patient case record form, the     electronic form of which will be broth to Trop. Med of Mahidol University for final analysis.     The patients will be receiving the reasonable transportation cost for follow-up visits as     well as one bed-net at the end of enrollment.   "
216368|NCT00682591|"     Prospective, longitudinal multi-center study performed in 15 participating substitution     centers in Germany.      Aims:      - Primary objective: To compare the impact of the different substitution drugs (methadone,     buprenorphine, and suboxone) on the neurocognitive, emotional, and quality-of-life-related     tolerability in opioid dependent patients under HCV treatment.      - Secondary objective: To investigate if IFN therapy impairs efficacy (with respect to e.g.     retention rates, concomitant drug use and in particular neurocognitive function) and     tolerability of agonist maintenance treatment with methadone, buprenorphine, or suboxone   "
216369|NCT00682604|"     This research had as a goal to characterize the social demographic profile, nutritional     status, the presence of chronic non-transmissible diseases and food intake of the community     health agents who belong to five family health units in the east zone of Sao Paulo City.   "
216370|NCT00682617|"     Osteoarthritis is the most common form of arthritis in the United States. It is estimated     that 20 million Americans have arthritis, and the annual societal cost is $95 billion.     Several exercise studies have shown modest improvements in disability, physical performance,     and pain in subjects with knee osteoarthritis. While similar results have been suggested in     hip osteoarthritis, well-designed randomized clinical trials have not been conducted.     Exercise programs appear beneficial but without adherence, the beneficial effects of exercise     for knee and hip osteoarthritis decline over time. A well-designed, evidence-based,     arthritis-specific study controlling for exercise duration, frequency and adherence is     needed. The objective of this study is to determine the effects of structured exercise     programs on self-reported pain and disability in adults with hip osteoarthritis. This     prospective, randomized study with a wait-list control is designed to develop preliminary     data to support an R01 funding request for a large, randomized clinical trial. All exercise     interventions and outcome assessments will take place at OHSU in the Orthopaedics and     Rehabilitation Clinics, Rehabilitation Services physical therapy gym, and the General     Clinical Research Center. Subjects will be selected to include individuals representative of     the larger population with documented hip osteoarthritis. This three-month study will     evaluate the effects of an aerobic and resistance exercise program on pain and disability in     individuals with hip osteoarthritis. Outcome assessment will follow the Outcome Measures in     Rheumatology (OMERACT) recommendations for a core set of outcome measures for clinical trials     in arthritis and assess pain, physical function, patient global assessment, and joint     imaging. Data analysis will focus on comparing pre- and post-intervention endpoints using     conventional statistical analyses such as repeated-measure analysis of variance for repeated     continuous measures (e.g. walking distance), and non-parametric methods such as Chi-square or     frequency analysis for proportions (e.g. visual pain scores).   "
216371|NCT00682630|"     The objective of the study is to determine the bioequivalence of the combination of     pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference     tablet administered as a single total dose of 720:240 mg in healthy adults.   "
216372|NCT00682643|"     The purpose of this study is to assess long-term ocular safety of fluticasone furoate nasal     spray in adult and adolescent subjects diagnosed with perennial allergic rhinitis.   "
216375|NCT00682682|"     Ultimately, the purpose of the present study is to help improve pain control in burn patients     during wound care and physical therapy, where pain levels with opioids alone are often     excessively high.      This study measures how much virtual reality pain distraction reduces pain compared to     traditional opioid pain meds, and whether there is additional pain reduction when Virtual     Reality distraction + Opioids are combined. In addition to studying the amount of pain     reduction, this study will also measure side effects (if any) of the two treatments (Virtual     Reality pain distraction and Opioids) alone and when combined.      Healthy volunteers will be recruited from advertisements will undergo a trial of the pain     testing. They will receive a series of brief stimuli (at a painful but tolerable safe     intensities they select and approve during baseline testing), separated by intervals of no     pain.      Participants will rate how much pain they felt after each brief stimulus, and will fill out     side effects questionnaires after finishing the pain session.      Subjects will participate in each of the four conditions in which the order is randomized.        -  No opioids (0ng/ml hydromorphone) + no virtual reality Snow World distraction        -  No opioids + yes virtual reality Snow World distraction        -  Moderate dose of pain medicine (4ng/ml hydromorphone) + no virtual reality        -  Moderate dose of pain medicine + yes virtual reality Snow World distraction      It is our hypothesis that VR distraction + opioids will show a reduced perception of pain in     subjects more than opioids alone or no intervention (control).   "
216376|NCT00682695|"     The purpose of this study is to find risk factors for hemorrhagic stroke.   "
216388|NCT00682851|"     This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test     and BVBlue Test) that give results in 10 minutes are as accurate as standard tests to     diagnose common vaginal infections.   "
216389|NCT00682877|"     The purpose of this study is to determine the correlation between gastric residence time of     the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled     meal as measured by gastric emptying scintigraphy for subjects 65 years of age and older.   "
216390|NCT00682890|"     The purpose of this research study is to determine if adding Metformin, a drug that reduces     insulin resistance, to birth control pills will reduce the risk of developing type 2     diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS   "
216942|NCT00690729|"     This 16-week program examines cognitive behavioral bibliotherapy to typical     therapist-directed cognitive behavior therapy for children and adolescents with Obsessive     Compulsive Disorder.   "
216377|NCT00682708|"     Malnutrition is a critical public health problem in developing countries. Malnutrition may be     linked to more than one half of the deaths in children under 5 years old. In July 2001, after     an intervention related to a measles epidemic, Medecins sans Frontieres-France opened a     nutritional program in Maradi, in the South of Niger. The introduction of ready to use     therapeutic foods (RUTF), in particular Plumpy'Nut (Nutriset, France) allowed for the     treatment of the majority of children at their homes using ambulatory treatment. Children     with complicated cases were cared for in an inpatient center. With ambulatory treatment the     number of children cared for in the MSF program reached close to 70000 in 2006.      This study aimed to assess the effect of a 3-month distribution of RUTF in the context of a     preventative supplementary feeding program. The primary hypotheses were that short-term RUTF     supplementation at the village-level would prevent declines in weight-for-height and reduce     the incidence of wasting in children 6 to 60 mo of age over a period of 8 mo. Because RUTF     may have additional health effects, the intervention effect on height-for-age, stunting,     mortality and morbidity from malaria, diarrhea, and respiratory infection were also examined.   "
216378|NCT00682721|"     We will be examining the effects of suppressive valacyclovir therapy on the stability of     vaginal flora in women who are seropositive for HSV-2. We have preliminary data that suggests     the presence of HSV-2 increases the risk for Group B Streptococcus colonization as well as     many other deleterious organisms (e.g. Streptococcus pseudoporcinus), in addition to     increasing the risk for acquisition of BV-associated vaginal flora. We will be examining the     effects of suppressive therapy on the vaginal flora of any HSV-2 seropositive woman.   "
216379|NCT00682734|"     Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do     not know the best dose to administer. This study compares three different doses of     metoclorpamide.   "
216380|NCT00682747|"     The purpose of this study is to determine whether hyperbaric oxygen is effective in the     treatment of a dry mouth that occured after radiotherapy for head and neck tumours.   "
216381|NCT00682760|"     To compare the efficacy and safety of Korean botulinum toxin A (KbtxA, Pacific     Pharmaceuticals, Korea) against Botox in the treatment of essential blepharospasm, we     performed a double-blinded, randomized, comparative trial comparing KbtxA and Botox for     treatment of blepharospasm in 60 patients of the intention to treat population and 52     patients (26 patients from each group) of the per protocol population. The improvement of     severity of spasm (SS) at 4 weeks post-injection as a primary efficacy outcome, qualifying     non inferiority to the control group, Changes in eyelid closure force (CF) and functional     visual status (FVS) after injection for secondary efficacy outcomes, and adverse effects for     safety evaluation. Improvement of SS was noted in 90.3% of the KbtxA group and 86.2% of the     Botox group. There were no significant differences between treatment groups in the changes of     CF and FVS after injection (p>0.05). Adverse effects developed in 16.1% of the KbtxA group     and 27.6% of the Botox group, but no serious adverse events were found in either group. KbtxA     was not inferior to Botox in treatment efficacy and was clinically safe with no serious     adverse effects when used to treat essential blepharospasm.   "
216382|NCT00682773|"     Oral anticoagulant therapy with warfarin is essential for the prevention of strokes and other     thromboembolic events related to various medical conditions; however, use of this therapy can     be associated with an increased risk of serious bleeding. In a previous AHRQ-funded study, we     have demonstrated that the prevalence of conditions for which warfarin is indicated is high     among frail elderly nursing homes residents, use of warfarin in this setting is very common,     and the quality and safety with which warfarin is used is far from optimal. The research     described in this application resonates with AHRQ's stated priorities for FY2006. The premise     underlying the proposed intervention study is that errors in prescribing and monitoring     warfarin for nursing home residents are related more to problems in the system of care, than     to deficits in the knowledge base of health care providers. We propose a low technology     intervention for improving the quality and safety of anticoagulant therapy with warfarin in     the nursing home setting. The intervention focuses on maximizing the effectiveness of     communication between the nursing staff and physicians of nursing home residents on warfarin.     The intervention will build on an established approach for situation briefing drawn from the     U.S. armed forces: SBAR - Situation, Background, Assessment, Recommendation. We will test the     effectiveness of this approach through a matched, cluster-randomized trial, with     randomization at the level of the nursing home. Our study has the following specific aims:     (1) to determine whether a nursing home warfarin management protocol emphasizing facilitated     communication to physicians will improve the quality of anticoagulation management, which     will be assessed using widely accepted quality measures; (2) to determine whether the     intervention will lower the rates of adverse events (bleeds and thromboembolic events) among     warfarin-treated residents of intervention group nursing homes compared to control nursing     homes; and (3) to produce a toolkit for use by nursing homes that will allow dissemination of     this approach to enhancing the quality and safety of warfarin for the frail elderly. If     successful, this approach may serve as a model for improving the safety of other medication     categories associated with high rates of preventable adverse drug events, and for protecting     nursing home residents, and frail elderly cared for in other settings, who are at special     risk for medication-related problems.   "
216383|NCT00682786|"     Determine if genotype-directed neoadjuvant chemoradiation, using information from the     thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging     in high risk patients compared to historical controls.   "
216432|NCT00683449|"     The objective of this clinical study is to examine the safety and effectiveness of     intravenous MN-221 compared to placebo when administered as an adjunct to standard therapy in     subjects experiencing an acute exacerbation of asthma.   "
216384|NCT00682799|"     This is a prospective, non-randomized multi-center multi-national study to evaluate the     chimerism measured by STR and SNP in patients with hypoplastic RC and normal karyotype     transplanted with a preparative regimen of reduced intensity.      Primary objectives:        -  To study hematopoietic chimerism in whole blood and different cell population (CD14,          CD15, CD 56, CD3, CD19) as well as in dendritic cells and regulatory T-cells after SCT          with RIC in patients with RC        -  To compare the results of chimerism obtained with standard STR PCR (sensitivity 1%) with          those obtained with SNP PCR (sensitivity 0.1- 0.01%)      Secondary objectives:        -  To evaluate the relationship between mixed chimerism and hematological engraftment, OS          and EFS        -  To study the impact of mixed chimerism in plasmacytoid dendritic and regulatory T-cells          on the incidence of acute and chronic GVHD   "
216385|NCT00682812|"     The aim of this study is to evaluate the significance of an elevated high-risk HPV (HR-HPV)     viral load.   "
216386|NCT00682825|"     The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and     Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of     patients remembering being awake during surgery. The BIS monitor may be able to measure how     asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be     compared with using the concentration of anesthetic gas to guide anesthesia.   "
216462|NCT00683852|"     The purpose of this study is to determine whether a reduced dose of aripiprazole is effective     in treating patients with major depressive disorder   "
216391|NCT00682903|"     The objective of the project is to evaluate advantages from the use of a bearable continuous     interstitial glucose monitoring device (GuardianR) during educative sessions of diabetic     patients dedicated to functional insulin therapy teaching. This concept of intensified     treatment is based on testing and explanation of simplified decision making algorithms to     adapt insulin dose to every true life conditions. As self monitoring of capillary glucose     level is needed to validate those algorithms, we postulate that using a device able to     permanently control interstitial glucose readable by both medical team and patient himself     (during the session and the 5 following days after discharge) could significantly improve     safety and efficiency of such educative session.   "
216392|NCT00682916|"     Obesity and type 2 diabetes have clearly been linked together and identified as epidemics in     much of the developed world. Historically several different dietary fibers have been used as     means of reducing body weight and the related development of type 2 diabetes. These studies     have generated mixed, if not inconsistent, results suggesting that none of these fibers     promise a solution to either of these two conditions. We are proposing to investigate the     effects of including a new soluble fiber, a-cyclodextrin, FBCx® (to be called Y288 in this     study), into the diet of adult overweight volunteers.   "
216393|NCT00682929|"     The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral     cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe     and effective in reducing the symptoms of spasticity and tremor in patients with     secondary-progressive or primary progressive multiple sclerosis.   "
216394|NCT00682942|"     The investigators aim to compare four different lung recruitment techniques (described in     literature) to Computed tomography scan analysis.   "
216395|NCT00682955|"     This project is aimed to evaluate the efficacy of two different zinc formulations     (dispersible Zinc tablets versus Zinc suspension) for the treatment of acute diarrhea in     hospital based settings. Additionally we intend to compare the effectiveness of treatments of     different groups on the basis of usage of Zinc in the treatment of diarrhoea, and to monitor     additional treatment components such as ORS, antibiotic usage rates.   "
216396|NCT00682968|"     Hypertension affects nearly 50 million Americans [1] and is the most common chronic condition     among veterans. Unfortunately, many patients with established hypertension have poorly     controlled blood pressure (BP); control rates in the VA are at approximately 70% currently.     While clinician failure to aggressively manage hypertension through therapeutic     intensification (clinical inertia, or failure to intensify pharmacotherapy appropriately)     contributes to poor blood pressure control, even when doctors do intensify therapy, 43-78% of     patients fail to adhere to recommended therapies, indicating that adherence remains a central     problem in hypertension care. This suggests important opportunities for interventions to     improve risk factor control by working through clinicians, their teams, or their delivery     systems, as well as with patients, to address both patient adherence and clinical inertia.   "
216397|NCT00682981|"     The Phase I portion of this protocol will determine the best phase II dose and schedule of     obatoclax with carboplatin and etoposide in patients with extensive-stage small cell lung     cancer. The Phase II portion will evaluate the response rate to this regimen.   "
216428|NCT00683397|"     Consecutive patients with acute or previous venous thromboembolism are enrolled in this     registry. Using a standardized questionnaire, clinical data detailing venous thromboembolism     and contributing VTE risk factors are recorded. Results of technical and laboratory     investigations including screening for thrombophilic disorders were additionally entered into     the database.   "
216429|NCT00683410|"     To collect post-marketing information on the safety of Prevenar in Filipino patients   "
216398|NCT00682994|"     The goal of this research study is to learn about any differences in certain health-related     preferences between patients with cancer and their families.      The main preferences being studied are how decisions are made about healthcare, as well as     how much information people want to know about cancer.      Specifically, researchers will compare questionnaire and interview data from     Hispanic-Americans living in the United States (the M. D. Anderson part of this multicenter     study) with Hispanics living in Latin America (in particular, Argentina, Chile, and     Guatemala).   "
216399|NCT00683007|"     The purpose of this study is to examine how the heart functions when a calculated amount of     blood is removed and how two fluids, Lactated Ringer's (considered the standard replacement     fluid) and Hypertonic Saline, re-expand the vascular system.   "
216400|NCT00683020|"     To measure the effects of a Medical health plan-directed automated telephone self-management     support system (ATSM) on patient outcomes among ethnically diverse health plan enrollees with     diabetes.   "
216401|NCT00683033|"     Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate     abuse or dependence will meet with research staff on two days for quit preparation sessions     (2 per day). These sessions include testing a breath sample for evidence of smoking twice     each day (separated by at least 5 hours), counseling based on Public Health Service (PHS)     guidelines for quitting smoking during the second session each day, and setting a quit date.     After these sessions, participants will be randomly assigned to one of two 4-week conditions:     (a) standard care or (b) standard care plus prize CM for smoking abstinence with the     opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g.,     CO ≤ 6ppm; cotinine ≤ 30ng/mL). Nicotine withdrawal and related measures will be assessed     throughout the intervention. Follow-up data will be collected through 6-months post-quit     date.   "
216402|NCT00683046|"     Objectives:        1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and          non-myelo-ablative ablative stem cell transplantation in patients with hematologic          malignancies.        2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based          in vivo T-cell depletion, in patients with hematologic malignancies undergoing          non-myelo-ablative stem cell transplantation.        3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion          and non-myelo-ablative ablative stem cell transplantation in patients with hematologic          malignancies.   "
216403|NCT00683059|"     The purpose of this study is to determine what effects the drug Abraxane has on bladder     cancer.   "
216463|NCT00683865|"     Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease   "
216404|NCT00683072|"     Although patient-ventilator asynchrony is a frequent phenomenon, its course following     management is unknown. As the aid of a data recording system, we try to observe the     consequence of patient-ventilator asynchrony following management. Our target is aimed at the     patients with high asynchronization index ( > 10%) as this group of patients have been shown     to have prolonged course in intensive care unit and are also prone to be tracheostomized   "
216405|NCT00683085|"     Pancreatic cancer is the fourth leading cause of cancer death in the United States, and no     combination therapy is far superior to gemcitabine alone. Vascular endothelial growth factor     receptor type 1 (VEGFR1) is expressed on the tumor vessels and a candidate of tumor     vessel-specific peptide vaccination strategy to induce T cell immune response. We conducted     the study to confirm the safety and efficacy of combined modality intervention using     conventional dose of gemcitabine with peptide vaccination targeting tumor-vessel specific     VEGFR1 in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.      Gemcitabine 1,000 mg/m^2 (body surface area) will be administered on day 1, day 8, day 15,     day 29, day 36, and day 43, respectively.      VEGFR1-derived HLA-A*02:01-restricted peptide (VEGFR1-A02-770; TLFWLLLTL) emulsified with     Montanide ISA51 will be subcutaneously injected twice weekly for 8 weeks (total 16 doses).   "
216406|NCT00683098|"     Evaluation of long-term results for chronic pain and impairment of daily activities after     endoscopic total extraperitoneal repair of recurrent inguinal hernia with inguinal pain     questionnaire (IPQ).   "
216407|NCT00683111|"     Aspirin and clopidogrel +/- heparin or thrombolytic co-therapy is well established and     effective treatment for unstable cardiac patients. However, the major complication was     gastrointestinal bleeding (GIB) due to peptic ulcer. In the prevention of GIB, anti-ulcer     drug either H2-receptor antagonist (H2RA) and proton pump inhibitor (PPI) were commonly     prescribed. There has been no prospective controlled study to compare the efficacy of these     two classes of anti-ulcer drugs.   "
216408|NCT00683124|"     The major clinical problems in patients with Marfan Syndrome (MFS) are aortic root dilation     (ARD), dissection and rupture. Although the available treatments (beta-blockers, BBs) improve     the evolution of the disease, they do not protect MFS patients from progression of ARD and     dissection. A key molecule that negatively influences cell growth, differentiation, survival     and death in MFS is TGFb which is antagonised by existing drugs employed in the clinical     practice, the Angiotensin II receptor blockers (ARB).   "
216409|NCT00683137|"     The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to     placebo in patients with moderate or severe pain following bunionectomy surgery, and to     evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures     and on the occurrence of opioid related symptoms.   "
216425|NCT00683358|"     Feasibility and efficacy of combined modality intervention using chemotherapeutic agent     gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in     case of advanced/inoperable or therapy-resistant pancreatic cancer patients.      Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43,     respectively.      HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with     Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).   "
216426|NCT00683371|"     Mucosal biopsies, endoscopically-guided brush samples of mucus, and a saline lavage taken     from the maxillary sinuses of ten CRS patients undergoing sinus surgery are analyzed using     three microarrays in order to detect bacteria, fungi and viruses. Ten control patients with     normal sinuses will have the same samples taken. The hypothesis is that bacterial, fungal,     and viral communities present in the maxillary sinus of patients with CRS are significantly     different from those patients with healthy sinuses, and that microorganisms identified in     patients with or without CRS will differ from previously published data obtained using other     techniques.   "
216410|NCT00683150|"     Primary Objective:      The primary objective of the study is to characterize and measure the impact of major surgery     on the kinetics of endothelial function during the perioperative period. Reactive hyperemia,     characterized by Digital Thermal Monitoring (DTM), will be utilized to characterize this     during the perioperative period in patients undergoing major abdominal or thoracic surgery.     This will attempt to characterize the relationship between impaired endothelial function, the     extent of surgical insult, and the risk for adverse postoperative outcome.      Secondary Objectives:      Secondary objectives of this study will evaluate the following:        -  The incidence of major complications in correlation to reduced preoperative reactive          hyperemia        -  The incidence of major complications in correlation to reduced postoperative reactive          hyperemia (calculated as absolute value and as the change from baseline [delta]).        -  It is anticipated that two factors (namely, preoperative cardiovascular risk and the          extent of the intraoperative inflammatory response) will predominantly contribute to the          impaired microcirculatory/hyperemic/endothelial function and should therefore be          accounted for in this study. The correlation between impaired reactive hyperemia and          these two contributory factors will be evaluated.             1. Preoperative cardiovascular risk will be assessed using risk scoring systems that               attempt to infer patient risk according to preoperative co-morbidities, namely The               ASA Physical Status Classification System24, The Lee Modified Cardiac Risk Index,25               and The University of Texas M. D. Anderson Cancer Center Modifiers to the Lee               Modified Cardiac Risk Index (an unvalidated scoring system that considers factors               unique to the cancer surgical population), and The Metabolic Syndrome. The latter               represents a larger at-risk patient population who has yet to develop symptomatic               cardiac lesions (and therefore will not be identified by the Lee modified Cardiac               Risk Index).             2. Intraoperative inflammatory response will be assessed using quantitative assays for               C-RP, and cytokines.        -  Multivariate analysis will analyze for intraoperative perturbations—including          hemodynamic (heart rate, blood pressure), temperature, and fluid shifts (blood loss,          transfusions.   "
216411|NCT00683163|"     This study will test in several innovative ways, several different combinations of PTH and     oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The     intension is to provide other options for treatment than the current standard 2 year course     of drug therapy. These options may lead to treatment where the two years of therapy are     spread over several years.   "
216412|NCT00683176|"     The purpose of this study is to evaluate the effect of choline fenofibrate on the regression     of macular edema in eyes of subjects with type 2 diabetes mellitus (T2DM) presenting with     diabetic macular edema (DME)   "
216413|NCT00683189|"     Objectives/Purpose:      To determine the safety and efficacy of a Vitamin K (Vit K) antagonist (warfarin) in treating     Metachromatic Leukodystrophy (MLD).   "
216414|NCT00683202|"     In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian     responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects     undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian     hyperstimulation.   "
216464|NCT00683878|"     The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can     help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well     controlled on TZD alone. The safety of this treatment will also be studied   "
216415|NCT00683228|"     This is a pilot study that aims to        1. Evaluate the effectiveness of using a structured tobacco cessation education program,          CEASE (Clinical effort against second hand smoke exposure), NY, delivered by pediatric          residents in the outpatient continuity clinic of the pediatric residency program in          reducing the exposure of infants to second hand smoke.        2. Evaluate the efficacy of using a second hand smoke exposure biomarker, Urine cotinine          level measurement and feedback as an adjunct to counseling.   "
216416|NCT00683241|"     This study is open to women with recurrent epithelial ovarian carcinoma or primary peritoneal     cancer. Subjects will be asked to donate either a piece of their tumor or malignant effusion     in order to make the first part of the vaccine or lysate. If enough of the lystate had been     collected to make the first part of the vaccine, then subjects may enroll in the study as     long as they meet the rest of the entry criteria.      After is determined that a subject is eligible to enroll into the study, you will have to     donate some blood in order to make the second part of the vaccine. After this, the blood and     vaccine are mixed together to make the vaccine called DCVax-L. You will be given two dose of     a drug called Avastin every other week (Avastin will be given through your vein) and a oral     chemotherapy called Cytoxan. One week after your last dose of oral Cytoxan, you will receive     3 vaccines given every other week for the next month. After the first two doses of vaccine,     you will also receive more Avastin. During the study you will be seeing your study team to     have physical exams, blood drawn in order to monitor your health and have blood drawn for     research. The study team will contact you for the next 5 years in order to determine how you     are doing.   "
216417|NCT00683254|"     Commercially-available internal nasal stents placed inside the nostril should produce     decreased nasal obstruction detectable subjectively (volunteers will fill out a survey) and     objectively (degree of obstruction will be measured with a rhinomanometer which measure     resistant of airflow while breathing through nose).   "
216418|NCT00683267|"     Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in     patients undergoing total hip replacement   "
216419|NCT00683280|"     In total, 70 smokers will be randomized to: varenicline alone (an FDA-approved smoking     cessation medication) or varenicline plus contingency management (CM) (a behavioral procedure     with rewards for target behaviors, like smoking abstinence). Patients in both conditions will     receive varenicline for 12 weeks with standard smoking cessation therapy and regular breath     and urine sample monitoring for smoking. Patients assigned to CM will earn chances to win     prizes for each breath sample that tests negative for smoking, and urine samples that test     negative for smoking will result in even greater chances for prizes. More CM patients are     expected to achieve and maintain abstinence than patients receiving varenicline alone.   "
216420|NCT00683293|"     The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic     hysterectomy regarding operating time peri-operative outcome and costs.   "
216421|NCT00683306|"     The purpose of this study is to provide gefitinib treatment to patients who, on completion or     closure of other gefitinib clinical studies, were either receiving placebo treatment, or are     continuing on the same dose and regimen of gefitinib established in their preceding study,     for as long as the patients continue to derive benefit.   "
216422|NCT00683319|"     RATIONALE: Gathering information about how young patients with ependymoma respond to standard     combination chemotherapy and learning about the long-term effects of this treatment may help     doctors plan better treatment.      PURPOSE: This phase III trial is observing young patients with ependymoma undergoing standard     combination chemotherapy.   "
216423|NCT00683332|"     The purpose of this study is to collect post-marketing information on the safety of Tygacil     in Filipino patients.   "
216424|NCT00683345|"     Fatigue is a prevalent phenomenon in Primary Sjøgrens syndrome (PSS). Observations indicate     that the cytokine IL-1 is of importance for this phenomenon. In this study the investigators     block IL-1 by giving Anakinra (an IL-1 receptor antagonist) to patients with PSS.   "
216427|NCT00683384|"     The purpose of this study is to collect post-marketing information on the safety of Enbrel in     Filipino patients.   "
216433|NCT00683462|"     A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will     be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with     DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping     will be completed at screening and slow metabolisers will be excluded from participation in     this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made     during each treatment period. Safety and tolerability assessments will be a major component     of the trial and all serious adverse events (SAE) will be immediately (within 24 hours)     reported to both Targacept and to AstraZenca.   "
216434|NCT00683475|"     The purpose of this study is to determine whether IMC-A12 or IMC-1121B (ramucirumab) with     Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent     prostate cancer (APIC).   "
216435|NCT00683488|"     This is an exploratory study that will adapt and test a combined cognitive behavioral     treatment and contingency management intervention for alcohol and/or marijuana abuse for use     in HIV-infected adolescents.   "
216436|NCT00683501|"     A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase 1I Study     to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in     Previously Untreated Patients with intraocular Hypertension   "
216437|NCT00683514|"     This is a multicenter, open-label, randomised, phase III study of 2 cycles of oral     vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either     two more cycles of consolidation therapy with oral vinorelbine and cisplatin plus Best     Supportive Care (BSC) or BSC alone in patients with unresectable locally advanced non small     cell lung cancer (NSCLC).      The primary objective is to compare progression-free survival in both arms, the secondary is     to evaluate the response rate, overall survival in both arms, to evaluate the safety profile     in both arms and to assess quality of life by the LCSS questionnaire.   "
216438|NCT00683527|"     To examine if early iron supplementation (starting oral iron at 14 days of life) would     improve the nutritional iron status(measured by serum ferritin) of very low birth weight     infants at postnatal age of 60 days, when compared to the standard regime of starting iron at     2 months of life.   "
216439|NCT00683540|"     The Veterans Administration (VA) has embraced the use of implementation research as a     critical way to improve care by facilitating the adoption of proven medical practices. Yet     implementation science still remains rudimentary. Challenges exist in judging the success of     an implementation project. Rather than relying solely on hard outcomes, an investigator must     also assess how effectively an intervention is put into place at a site. This assessment     comes via a formative evaluation (FE) plan. The FE plan can contain such diverse data     elements as the number of fliers distributed about the intervention, how often an     intervention advocate speaks to participants, the content derived from team meeting notes,     and themes extracted from focus groups. The diversity of such data elements can appear     foreign to investigators trained in traditional health services research. The FE plan can     also lead to confusion about what to measure, when, and how to integrate the various measures     into a unified whole. Complicating matters is the fact that FE is often qualitative--such as     interviews, focus groups, and meeting notes which can make data difficult for investigators     to interpret. Thus, there is a pressing need to provide clarity on how FE is to be used in     implementation studies. This Short Term Project proposal offers a three-part approach toward     specifying the best FE practices: first, a systematic review of the literature; second,     qualitative interviews with VA implementation investigators; and third, a panel discussion of     national experts, funded through a VA Implementation Collaborative Award. The panel     discussion will outline FE guidelines based on the researchers expertise, the systematic     review, and the qualitative interviews.   "
216440|NCT00683553|"     This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic     study. The study will be conducted in approximately 10 sites in the United States. Up to 48     patients at high risk for AKI (CCF score ≥ 5 OR an estimated GFR (eGFR) <60 mL/min/1.73 m2)     who have undergone major cardiovascular surgery will participate. Patients will receive a     single IV injection of I5NP or placebo following cardiovascular surgery. I5NP will be     administered 4 hours (+/- 30 minutes) following removal of the cardiopulmonary bypass machine     (CBM).      The duration of the study is approximately 44 days, inclusive of a 14 day screening period.     Patients will be contacted by phone at 6 and 12 months for follow-up questions. Patient     visits are screening, day of surgery, hospital in-patient Days 1, 2, 3 - 5 and Day 7 or     hospital discharge. Safety follow-up will continue until 30 days post-surgery. 2 phone calls     will be made at 6 and 12 months after date of surgery.   "
216441|NCT00683566|"     Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is     abnormally synchronized and rhythmic. The oscillatory activity prevails at 8-30 Hz in     untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels     inversely correlates with motor impairment. Moreover, these different levels in BG-cortical     loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment     following treatment with dopaminergic drugs and is partially suppressed prior to and during     voluntary movements. An unanswered question is how do BG-cortical loops become so prominently     engaged in this oscillatory activity? One possible explanation is that the resonance     frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that     oscillations in this band are transmitted particularly well. So we hypothesize loop     resonances in the 8-30 Hz frequency band at rest, which should be suppressed during movement     and following dopaminergic therapy.   "
216442|NCT00683579|"     ATN 071 is a prospective cohort study comparing neurocognitive functioning in four groups of     youth, age 18-24: Two groups with CD4+ T cells above 350 cells/mm3 and HIV RNA >1,000     copies/ml, one initiating HAART (Group 1) and the other not initiating treatment (Group 2);     and two groups with CD4+ T cells < 350 cells/mm3, one initiating treatment (Group 3) and the     other not initiating treatment (Group 4). Groups 2 and 3 represent standard of care. Group 1     and a portion of group 2 will be co-enrolled in ATN 061 and will be randomly assigned to     group by that protocol.   "
216443|NCT00683592|"     This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is     designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers     of treatment response associated with vilazodone use in adult patients diagnosed with MDD by     the DSM-IV-TR criteria.   "
216444|NCT00683618|"     This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with     Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and     history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less     than 10%, following 6-week treatment and a possible 6 week extension treatment.   "
216445|NCT00683631|"     The purpose of this protocol is to provide access to Therasphere treatment for patients with     liver tumors.   "
216446|NCT00683644|"     There is widespread belief and some evidence to indicate that zinc can successfully treat     tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of     this study is to establish the effectiveness of zinc for the treatment of tinnitus in     individuals 60 years of age and older. Subjects will be randomly assigned to either receive     zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed     over to the other group.   "
216447|NCT00683657|"     This protocol will compare 24 hour glucose control for subject taking saxagliptin and     metformin extended release (XR) versus metformin XR alone   "
216448|NCT00683670|"     The purpose of this study is to investigate a method of using dendritic cells (a kind of     white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma     cells.   "
216465|NCT00683891|"     AZUR Pharma has received several reports from practicing psychiatrists prescribing FazaClo     showing that FazaClo patients start losing body weight instead of keep gaining it, after     being switched from other clozapine products or other atypical antipsychotics treatments.     Another important clinical observation reported by doctors is a considerable reduction in     hypersalivation when FazaClo administration is compared to other antipsychotic treatments.     Based on the findings described above, and on the real need for effective and safer     treatments for schizophrenia, AZUR Pharma has decided to design and conduct an observational     study in a large number of patients taking FazaClo to prove the received clinical reports     from physicians. Better understanding and evaluation of these beneficial findings are     necessary to provide physicians information for improved treatment decision.   "
216466|NCT00683904|"     The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity,     and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with     non-small cell lung cancer.   "
216449|NCT00683683|"     Background: One of the 2010 Impact Goals of the Emergency Cardiac Care (ECC) Committee of the     American Heart Association is to double survival from cardiac arrest. Currently,     approximately 60% of adults and 50% of paediatric patients that regain spontaneous     circulation following cardiac arrest die before leaving the hospital. A key piece of the     chain of survival is this fifth link; the care of patients post-arrest. Although there are     several modalities recommended for post arrest care, therapeutic hypothermia is the only     in-hospital therapy that has been demonstrated in randomized clinical trials to improve     patient outcome after cardiac arrest. Despite the strong evidence for its efficacy and the     apparent simplicity of this intervention, recent surveys show that hypothermia is delivered     inconsistently, incompletely, and with undue delay in hospitals receiving resuscitated     patients; only 26% of physicians and 26% of hospitals regularly institute a hypothermia     protocol.      Primary Objective: To design and apply a knowledge translation program for the 2005 AHA     guideline on hypothermia post cardiac arrest and enable effective implementation of     hypothermia in 100% of eligible OHCA patients. The integration of two robust data collection     systems, which include both pre-hospital and in-hospital indicators, will give complete     process of care and clinical outcome information for all cardiac arrest patients.      Primary Endpoint: the proportion of eligible out of hospital cardiac arrest patients cooled     to 32-34°C within 6 hours of ED arrival.      Study Design: This project will be implemented through an established research collaborative     of 43 hospitals in southern Ontario currently participating in the Toronto site of the     Resuscitation Outcomes Consortium. A stepped wedge study design will be employed, whereby the     intervention will be rolled-out sequentially to the participating hospitals over a number of     time periods as sites reach pre-defined benchmarks. The multifaceted KT strategy will include     1) local multidisciplinary champions in ED, ICU, and Cardiology 2) A simple protocol for     application of hypothermia, tailored to local needs and policy; 3) Identification of     perceived and actual barriers to knowledge use; 4) Development of an implementation tool kit     and 5) Providing timely feedback on benchmarks for hypothermia and outcomes   "
216450|NCT00683696|"     The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on     mortality and morbidity of subjects with heart failure due to left ventricular systolic     dysfunction, already receiving optimized HF medication, with a narrow QRS width (< 130 ms)     and echocardiographic evidence of ventricular dyssynchrony.   "
216451|NCT00683709|"     Bipolar Disorder (BD) and Schizoaffective Disorder (SA) clients.        -  determine if after 12 months of treatment with clozapine, the BMI changes with clients          who are councelled as usual regarding weight gain while on Clozapine.        -  determine if after 12 months of treatment with clozapine, the BMI changes with intense,          structured councelling about diet and exercise.   "
216452|NCT00683722|"     The objective of the present study is to establish the safety and efficacy of multiple     administrations of PROCHYMAL™ (human adult stem cells) in subjects with moderate to severe     Chronic Obstructive Pulmonary Disease (COPD).   "
216453|NCT00683735|"     Objective: To assess the effect if co-administration of sitagliptin and metformin compared to     placebo on the incretin effect (based on the comparison of the insulin secretory response to     oral glucose load and an 'isoglycaemic' intravenous glucose load). Hypothesis: Treatment with     co-administration of sitagliptin and metformin provides a greater incretin effect compared to     placebo.   "
216454|NCT00683748|"     After transplantation, if insufficient immunosuppression is achieved, rejection and graft     loss follows. If to much immunosuppression is given, the patient suffers risk for infections     and malignancies. Despite careful dosing and monitoring of drug levels, the biological     effects of the immunosuppression given is difficult to predict and varies significantly. As a     result, the degree of immunosuppression (or immunosuppressive status) remains unknown and     clinical problems related to under- or over-immunosuppression are common. Thus, a method to     determine the degree of immunosuppression would be of great and direct clinical importance     and the results would be improved. T cells are the principal cells of the immunesystem     causing rejection. Furthermore, all immunosuppressive regimes targets T cells. Thus, T cell     reactivity could reflect the biological effects of the immunosuppression and the     immunosuppressive status. In addition, T cells are of crucial importance in the immunedefence     against viral diseases. Therefore, data on virus specific T cell reactivity could aid in     diagnosis, monitoring and treatment of viral disease. The proposed study aim to develop a     clinically useful method to monitor cellular immunity and the degree of immunosuppression     after transplantation by determinations of the specific T cell reactivity to several     clinically relevant viruses.   "
216455|NCT00683761|"     The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the     treatment of adult patients with progressive or recurrent malignant gliomas.   "
216456|NCT00683774|"     Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the     kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating     DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin     directly by inhibition of islet insulin release with diazoxide in obese women with PCOS     1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.   "
216457|NCT00683787|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more     effective when given together with or without vandetanib.      PURPOSE: This randomized phase II trial is studying docetaxel to see how well it works     compared with docetaxel given together with vandetanib in treating patients with metastatic     stomach cancer or gastroesophageal junction cancer.   "
216460|NCT00683826|"     Protein-rich diets appear to show some benefits in promoting weight loss. It is thought that     increased intake of leucine may account for some of this effect. This study is designed to     assess whether any of the beneficial effects of dietary leucine supplementation observed in     mice also apply to humans.      Specifically, our team would like to determine whether oral leucine supplementation in     overweight/obese humans increases metabolic rate, reduces body weight, improves glucose     utilization and/or, reduces circulating fat levels in the blood. We hope that the results     obtained from this pilot study will highlight the specific aspects of metabolic improvement     associated with increased daily leucine intake. This study will should provide data that can     be used to design more definitive trials with regard to dietary leucine supplementation.      Hypothesis      This pilot study is designed to accomplish the following two goals:        1. to assess whether any of the beneficial effects of dietary leucine supplementation          observed in mice also apply in humans. Specifically, we want to determine whether oral          leucine supplementation in overweight/obese individuals' increases basal metabolic rate,          reduces body weight, improves glucose tolerance and/or insulin sensitivity, and/or          reduces circulating Low-density Lipoprotein (LDL)-cholesterol levels.        2. To provide data that can be used to design more definitive trials with regard to dietary          leucine supplementation.      We hope that the results obtained from this pilot study will highlight the specific aspects     of metabolic improvement associated with increased daily leucine intake. This would in turn     lead to more rigorous clinical trials involving larger sample sizes, and with diverse     populations of different gender, age, and ethnic groups. Future trials may also be directed     to determine minimal doses and durations of leucine supplementation that are capable of     achieving clinically significant improvement in the cardio-metabolic risk profile in people.   "
216461|NCT00683839|"     The study will examine the effectiveness of public health dental practitioners using a brief     office based intervention designed to help patients quit smoking or smokeless tobacco use, as     compared to usual care.   "
216467|NCT00683917|"     PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.   "
216468|NCT00683930|"     This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally     twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other     corticosteroids. During the study, patients had their corticosteroid dose gradually reduced     if they responded to treatment. The anticipated time on study treatment was 12 months, and     the target sample size was <100 individuals.   "
216469|NCT00683943|"     This study will evaluate the side effects and tolerability of the drug lithium in patients     with spinocerebellar ataxia type I (SCA1) an inherited disorder caused by loss of nerve cells     in parts of the brain. Symptoms include ataxia (difficulty walking) and loss of muscle     coordination and strength. Recent studies suggest that lithium may be helpful in treating     some SCA1 symptoms.      People between 18 and 65 years of age with SCA1 who have only difficulty walking or who have     difficulty walking as well as tremor, hand incoordination or speech problems, may be eligible     for this study. Participation requires three hospital admissions at the NIH Clinical Center     and one outpatient visit.      Participants undergo the following tests and procedures:      Admission 1 (2-6 weeks)        -  Medical history, physical examination, blood and urine tests, electrocardiogram.        -  Evaluation of SCA1 symptoms (balance, walking, dexterity, tremor, memory, mood and          concentration).        -  Monitoring of liquid intake and output (urine) and weight changes.        -  Lithium treatment Start treatment and remain in hospital until the blood level of the          drug is stabilized; continue treatment at home after hospital discharge.      Admission 2 (2-4 days, 4 weeks after hospital discharge).        -  Repeat of some or all of the procedures done at the first admission.        -  Continue lithium in hospital and at home after discharge, with local physician checking          laboratory values as needed.      Admission 3 (2-4 days, 8 weeks after Admission 2).        -  Repeat of some or all of the procedures done at other admissions.        -  Stop lithium.      Outpatient Visit (4 weeks after Admission 3)        -  Evaluation of SCA1 symptoms.        -  Blood and urine tests.   "
216470|NCT00683956|"     Numerous efforts have focused on the development of closed-loop systems to control anesthesia     using the electrical activity of the brain (EEG) and EEG-based parameters as surrogate     measures of anesthetic depth. New systems have been recently developed to considerably     improve anesthetic control using model-based, patient-adaptive methods. The purpose of this     study is to evaluate the clinical efficacy of a new intelligent software, ReinLoop, in     delivering closed-loop, patient-specific hypnosis.   "
216471|NCT00683969|"     The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients     with myasthenia gravis receiving prednisone, or other corticosteroids. During the study,     patients will undergo gradual corticosteroid dose reduction, if they respond to treatment.     The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
216472|NCT00683982|"     Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be     clinically important in time of hospitalization and reduction of duration of diarrhea     secondary to rotavirus?   "
216473|NCT00683995|"     This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as     rescue medication for breakthrough pain.   "
216594|NCT00684736|"     Septic shock is a major cause of mortality and morbidity worldwide. Serotonin (5-HT) is     released by activated platelets into the circulation, and is mediator of endothelial     dysfunction. 5-HT metabolism is known in immune system via specific 5-HT receptor, also in     effects on the peripheral nervous system. Kinetic of 5-HT, tryptophan, kynurenine, MAO     activity and IDO activity in human septic shock was never investigated.   "
216474|NCT00684008|"     This is a phase I inter-patient dose escalation open labeled study assessing multiple doses     of CYT107 in patients of at least 15 years of age, who are recipients of HLA matched ex vivo     T cell depleted bone marrow or peripheral blood stem transplants.      The dose escalation design is aimed at establishing the absence of significant toxicity and     to define a biologically active dose in this patient population.      At each dose level, eligible patients will receive 3 doses of CYT107 injected subcutaneously     (under the skin of the arm, legs, or stomach) once a week for 3 weeks.      Groups of three patients will be entered at each dose level of CYT107. Three dose levels are     planned: 10 mcg/kg/week, 20 mcg/kg/week and 30 mcg/kg/week. Three patients must complete day     42 of the study at a dose level without a dose limiting toxicity (DLT) before there is     escalation to the next dose level.   "
216475|NCT00684021|"     Heart attacks are a leading cause of death for both men and women in the United States. A     heart attack occurs when blood flow to the heart is restricted, commonly due to a blood clot     that has formed in one of the coronary arteries. If the clot becomes large enough, blood flow     to the heart can be blocked almost completely and the heart muscle in that area can suffer     permanent injury or death. Although a percutaneous coronary intervention (PCI) can be used to     open up the blocked artery and restore blood flow to the heart muscle, there may be a     significant amount of heart tissue that has been irreversibly damaged. Recent studies have     shown that adult stem cells from bone marrow may be able to improve heart function after a     heart attack. This study will evaluate the safety and effectiveness of using adult stem cells     for improving heart function in people who have had a recent heart attack and a PCI.   "
216476|NCT00684034|"     The influence of hemodialysis on oxidative stress, endothelial activation, inflammation and     on the redox state of lymphocytes should be clarified as well as the putative relationships     between all these parameters.   "
216477|NCT00684047|"     The purpose of this study is to evaluate the safety and hemostasis effectiveness of human     plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.   "
216478|NCT00684060|"     More than 1 million Americans suffer heart attacks each year. Although current treatments are     able to stabilize the condition of the heart, none is able to restore heart function as it     was prior to the heart attack. Adult stem cells, which are immature cells that can become     many different types of cells, may offer a potential means of reversing or preventing     permanent damage caused by a heart attack. Recent studies have shown promise in using adult     stem cells from bone marrow to reverse damage to the heart muscle caused by a heart attack,     but more research is needed to assess the safety and effectiveness of stem cell use and to     discover the best time to administer treatment. This study will evaluate the safety and     effectiveness of using adult stem cell infusions 2 to 3 weeks after a heart attack for     improving heart function in people who have had a recent heart attack and a common procedure     called a percutaneous coronary intervention (PCI).   "
216479|NCT00684073|"     This study is designed to determine if opioid dependent subjects who are already receiving     Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex®     to Suboxone®. Subjects who are selected to participate in this study will continue their     prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the     study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone®     (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5).     The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects     will continue their pre-study prescribed dosage of Subutex®.   "
216480|NCT00684086|"     We propose a diabetes self-management program evaluation and dissemination project with three     components.        1. A six-month randomized trial to evaluate the effect of a community-based small group          Diabetes Self Management Program (DSMP) on the health related quality of life, metabolic          control and health care utilization of people with type 2 diabetes.        2. A long-term (12 month) longitudinal evaluation of the same program.        3. Two 5 day workshops to train others in California in how to lead and administer the          program.   "
216481|NCT00684099|"     This trial will determine the maximum tolerated dose the recommended phase II dose and the     efficacy of this combination in locally advanced or metastatic NSCLC patients   "
216482|NCT00684112|"     The primary aim of this study is to determine whether the use of gabapentin will improve     postoperative analgesia and reduce opioid consumption and side effects in children undergoing     corrective spinal surgery for idiopathic scoliosis. Secondary aims are to evaluate whether     use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases     persisting pain and improves patient satisfaction.   "
216483|NCT00684125|"     The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular     surgery is higher than after other cardiac surgical procedures. The aim of this study is to     evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft     silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using     large chest tubes. A prospective randomized trial.   "
216484|NCT00684138|"     Randomized, parallel group, subject masked, multi-center six (6) month follow-up study     comparing ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 implanted in both eyes     to ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.   "
216485|NCT00684151|"     The first phase of the study is a hospital-based cross-sectional, epidemiological survey. The     required sample size is 1,260 patients from 50 hospitals across Thailand. Each of the     hospital will enroll 10 to 40 consecutive patients, depending on case availability on the     date conducting the survey, with dyslipidemia and classified as high risk as defined by the     protocol. Lipid levels will be based on serological analysis conducted by a local laboratory.      For the second phase, each subject will be followed for survival status at 36 months after     enrollment. Such follow-up will be done by searching the Thai National Vital Event     Registration Database using subjects' Population Identification Number. All activities     regarding case selection and data collection will be done by well trained clinical research     associates (CRAs). The CRAs are from Khon Kaen University where the Statistical Coordinating     Center (SCC) for this project is based and are independent of the investigator. Random     auditing visits will also be performed by auditors independent of the SCC. These are to     ensure not only high quality data but also protecting right and well being of subjects.   "
216486|NCT00684164|"     Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in     particular those with neurological injury. Hyponatremia has been associated with worse     outcome, problems with memory and concentration and impaired balance. Standard treatment for     low sodium (salt) levels is to give the patient a salt containing solution thru a catheter     (small flexible tube) in a vein in the arm or leg. One of the major complications of this     treatment is excess body fluid which may cause heart problems or accumulation of fluid in the     lungs and may require additional medications to remove extra water from the body.      FDA approval has recently been granted for a new drug - Conivaptan - for use in hyponatremic     conditions. Conivaptan works by excreting free water from the body and thereby produce     concurrent rise in serum sodium concentrations. Conivaptan has not been evaluated     specifically in patients with brain injuries. The primary objective of this study is to     demonstrate the safety and efficacy of intravenous Conivaptan for the treatment of     hyponatremia in patients with brain injury. If effective, Conivaptan may represent a safe     treatment option.   "
216487|NCT00684177|"     The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin     ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which     includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of     age and older will be treated with topical retapamulin or placebo ointment twice daily for 5     days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14;     7-9 days after the end of therapy) in the intent-to-treat clinical population.   "
216488|NCT00684190|"     The purpose of the study is to evaluate if AZD3355 and Nexium interact with each other or     not, i.e. show the same or altered plasma concentration profiles when co-administered     compared to administered alone.   "
216489|NCT00684203|"     The study is designed to assess safety and effects of vorapaxar, when added to standard of     care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study     may also provide information about the effect of vorapaxar on preventing heart attack and     stroke in this subject population.   "
216490|NCT00684216|"     This trial studies the effects on quality of life and on time to second progression of the     sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment.     It is anticipated that the time on study (which is the time between randomization and the     discontinuation of the second treatment in the sequence) will be similar for both arms of the     study. The quality of life during this period, however, could be better in the patient group     receiving the most effective first agent in the sequence. If this proves to be true, the     conventional wisdom that endocrine therapy should be continued until no further endocrine     options remain, must be abandoned.   "
216491|NCT00684229|"     This study will compare recurrence rates in patients with colorectal cancer who will be     randomly assigned to epidural anesthesia/analgesia combined with general anesthesia or to     general anesthesia followed by opioid analgesia.   "
216492|NCT00684242|"     The goal of this clinical research study is to learn if lenalidomide can help to treat     uncontrolled pain caused by advanced cancer.      Primary Objectives:      1. Determine efficacy of Lenalidomide for the treatment of refractory cancer pain, as     measured by the change on Edmonton symptom assessment scale (ESAS).      Secondary Objectives:        1. To determine the effect of Lenalidomide on fatigue, sleep, depressed mood, nausea and          appetite/anorexia.        2. Determine changes in serum levels of inflammatory cytokines (IL-1beta, IL-6, TNF-alpha,          interferon(IFN)-alpha and IFN-gamma, and C-reactive protein) before and after treatment          with Lenalidomide.        3. Effect of Lenalidomide on T-cell subsets especially T-regulatory cells        4. Effect of Lenalidomide on the expression of costimulatory receptors, CD80, CD86, and          CD40, on myeloid and plasmacytoid dendritic cells        5. Safety (type, frequency, severity, and relationship of adverse events to study          treatment)   "
216493|NCT00684255|"     The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative)     chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family     donors and matched unrelated cord blood donors) will be well tolerated.   "
216494|NCT00684268|"     By chance the investigators found that iv. silibinin has a potent antiviral effect against     the hepatitis C virus. Based on the results of the dose finding study (published) te optima     dosing schedule is explored.This study will be evaluate whether the highest active dose given     for the optimal time combined with standard of care will result in a sustained virologic     response (=cure of hepatitis C).   "
216495|NCT00684281|"     The aim of this project is to follow cohort of patients with aMCI in order to establish     whether there are distinct subgroups in terms of evolution or aetiology, with distinct memory     profiles and profiles of mesiotemporal atrophy and metabolic change   "
216496|NCT00684294|"     Preliminary studies with a variety of vaccines suggest target accessibility (potential     immunogenicity) in a variety of solid tumors to immune directed approaches. However, four     primary factors limit the generation of effective immune mediated anticancer activity in     therapeutic application:        1. identifying and/or targeting cancer associated immunogen(s) in an individual patient        2. insufficient or inhibited level of antigen presenting cell priming and/or presentation        3. suboptimal T cell activation and proliferation        4. cancer-induced inhibition of the anticancer immune response in both afferent and          efferent limbs.      In an effort to overcome these limitations, we have designed a novel autologous vaccine to     address inability to fully identify cancer associated antigens, antigen recognition by the     immune system (i.e. antigen to immunogen), effector potency, and cancer-induced resistance.     We have completed clinical investigations using two different gene vaccine approaches to     induce enhancement of tumor antigen recognition which have demonstrated therapeutic efficacy.     Specifically, both the use of a GMCSF gene transduced vaccine and a TGFβ2 antisense gene     vaccine, in separate trials, have demonstrated similar beneficial effects without any     evidence of significant toxicity in advanced cancer patients. The GMCSF transgene directly     stimulates increased expression of tumor antigen(s) and enhances dendritic cell migration to     the vaccination site. TGFβ2 blockade following intracellular TGFβ2 antisense gene expression     reduces production of immune inhibiting activity at the vaccine site. These agents have never     been used in combination but the rationale of integrating enhancement of an anticancer immune     response concurrently with a reduction in cancer-induced immune suppression is conceptually     sound. We will harvest autologous cancer cells from patients with advanced refractory cancer.     We have constructed a TGFβ2 antisense / GMCSF expression vector plasmid and have successfully     demonstrated preclinical activity of the vector function following transfection by     electroporation and irradiation of autologous cancer tissue.   "
216497|NCT00684307|"     The main purpose of this study is to provide dose-guiding information by assessing the safety     and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of     AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for     an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial     fibrillation (AF) with one or more additional risk factors for stroke.   "
217244|NCT00697801|"     The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics     of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.   "
216498|NCT00684320|"     Generalized Social Phobia is characterized by severe social anxiety that leads to functional     impairment (Schneider et al., 1992). Despite its high prevalence, many individuals do not     receive treatment or are unresponsive to current therapies. Thus there is a clear need to     continue to develop highly effective and efficient treatments for social phobia. This three     year project aims to test a computerized treatment for social phobia in a double-blind,     placebo-controlled study designed to modify attention biases that may maintain anxiety.   "
216499|NCT00684333|"     Subcutaneous injections are a widely used method for drug delivery. One of its major     drawbacks is the pain inflicted during the process. Sindolor has developed the chemical-free     EZ-Ject Injector device, based on employing cutaneous local anesthesia on the injection site     by an electronic anesthetic system. The purpose of this study is to determine the safety and     efficacy of the EZ-Ject for subcutaneous injections.   "
216500|NCT00684346|"     The purpose of this study is to determine if 18Fluorodeoxyglucose (FDG) Positron Emission     Tomography (PET) imaging can detect changes in airways inflammation in Cystic Fibrosis (CF)     patients after treatment for a pulmonary exacerbation.   "
216501|NCT00684359|"     Single center randomized parallel group study to determine if:        1. there is a temporary increase in platelet reactivity after abrupt discontinuation of          clopidogrel due to a potential rebound phenomenon.        2. the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty          with adjunct drug eluting stent implantation compared to 12 month continuation of          clopidogrel on platelet reactivity. And the association with MACE up to 12 months post          coronary angioplasty.   "
216502|NCT00684372|"     Hypothesis: Early detection, and treatment, of BK virus infection after kidney     transplantation will prevent BK virus associated kidney transplant injury.      BK virus associated nephropathy (BKVN) is estimated to cause a progressive kidney transplant     injury in 1-10% of renal transplant recipients. Diagnostic and monitoring strategies for BKVN     is still being developed. Detectable virus in the blood by polymerase change reaction-test     (PCR) is predictive of BKVN. Additionally, PCR provides a objective estimate of the degree of     infection.      If early detection and treatment of BK virus infection is effective in preventing subsequent     kidney transplant injury has not been studied. However, renal injury and dysfunction develops     late in the natural course of BKVN and it seems likely that screening in combination with     early treatment would be beneficial for long-term transplant survival.      There is no established treatment for BK virus infection. Nevertheless, in kidney     transplanted patients diagnosed with BK virus infection, immunosuppression is reduced to     allow the patients own immune system to handle the virus. However, reduction of     immunosuppression has not been associated with rejection. This indicate that these patients     were over-immunosuppressed, predisposing them to BKVN. Therefore, to compare the degree of     immunosuppression in BKVN patients (over-immunosuppressed) to other patients (not     over-immunosuppressed) could yield interesting information. One possibility would be to     quantify these patients specific cellular immune response to BK virus but also to other     viruses (T cell reactivity).      Leflunomide (Arava) is an immunosuppressive drug, approved for the treatment of rheumatoid     arthritis, and has been used in more than 300,000 patients worldwide. Furthermore,     leflunomide has been used safely in humans after clinical kidney and liver transplantation     for more than 300 days. In addition to leflunomide's value in preventing rejection, it has     been shown to exert inhibitory effects on different viruses. Recently published pilot studies     suggest that leflunomide treatment of patients with BKVN significantly reduces the amount of     BK virus in blood and prevents recurrence of kidney transplant injury. At Karolinska     University Hospital, leflunomide has been used for treatment of BKVN and, in some of the     patients, renal function has stabilized and BK virus load has decreased significantly.   "
216503|NCT00684385|"     The purpose of this study is to provide ZD1839 for those patients with locally advanced     and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent     and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded     access basis due to their inability to meet eligibility criteria for on-going recruiting     trials, inability to participate in other clinical trials (e.g., poor performance status,     lack of geographic proximity), or because other medical interventions are not considered     appropriate or acceptable.   "
216504|NCT00684398|"     This study aims to understand predictors of adaptation and quality of life among adults     affected with neurofibromatosis type 1 (NF1) and autosomal dominant neurocutaneous condition.     NF1 carries a significant psychosocial burden for affected individuals. Aspects of NF1 that     are especially challenging include the unpredictable nature of the disease, variability in     severity of symptoms and medical complications, uncertainty in progression, and vulnerability     to stigmatization due to the highly visible and often cosmetically disfiguring features of     the condition. The literature suggests that because of these and other challenges posed by     NF1, affected individuals may struggle to adapt to their condition and, consequently,     experience poor quality of life. In this study, Lazarus and Folkman s Tranactional Model of     Stress and Coping is used as a framework to conceptualize adaptation and quality of life to     NF1. A cross-sectional design with quantitative methodology will be employed to investigate     the relationships of appraisals and stigma as predictors of adaptation and quality of life.     Adults affected with NF1 will be recruited via regional and national NF organizations and     websites, as well as through ongoing NIH clinical research protocols for NF1. Eligible     participants will be invited to complete a web-based, self-administered survey.   "
216505|NCT00684411|"     The purpose of this research study is to evaluate the overall response rate to imatinib     mesylate in participants with relapsed or refractory T cell non-Hodgkin's lymphoma. This drug     has been used in chronic myeloid leukemia and information from those other research studies     suggests that it may help to treat T cell non-Hodgkin's lymphoma.   "
216506|NCT00684424|"     The primary efficacy parameter will be the responder rate, defined as the proportion of     subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase   "
216507|NCT00684437|"     Objectives:      Smokers with varying levels of health literacy as assessed by the S-TOFHLA (i.e., inadequate,     marginal, adequate) recruited from the community will listen to one of 4 different types of     messages emphasizing the health consequences of smoking recorded on a computer in the form of     audio scripts (i.e., a human voice pre-recorded on a computer will read each message).     Messages written at a 5th to 6th grade reading level will be concurrently presented in     written form via a computer monitor and be manipulated in terms of 1) emotionality (i.e.,     primarily fact- vs. primarily emotion-based), and 2) framing (i.e., gain-framed messages that     highlight the potential benefits of quitting smoking vs. loss-framed messages that emphasize     the potential costs of failing to quit smoking). Emotionality and framing will be completely     crossed to create four different types of messages, 1) factual gain-framed (FGF), 2) factual     loss-framed (FLF), 3) emotional gain-framed (EGF), and 4) emotional loss-framed (ELF).      The primary objectives are to:        1. Examine whether main effects emerge for health literacy as assessed by the S-TOFHLA          (inadequate, marginal, adequate) and the different message types (fact- vs.          emotion-based and gain- vs. loss-framed) on the primary explicit and implicit outcomes:          a) intention to quit, and b) implicit and explicit attitudes toward smoking.        2. Examine whether health literacy interacts with the different types of messages          (fact-based vs. emotion-based and gain-framed vs. loss-framed) to influence the primary          explicit and implicit outcome measures: a) intention to quit smoking, and b) implicit          and explicit attitudes toward smoking.           A secondary, exploratory aim is to:        3. Examine potential associations between a) the primary explicit and implicit outcomes,          and b) the secondary explicit and implicit outcomes: knowledge, risk perception,          attitudes, self-efficacy, message evaluations, implicit fear of disease, and implicit          associations between smoking and disease.   "
216614|NCT00686036|"     The purpose of this study is to determine whether treatment with Zactima for up to 18 months     will prolong the off-treatment interval in patients who are undergoing intermittent androgen     deprivation therapy.   "
216508|NCT00684450|"     Safe use of cardiopulmonary bypass (CPB) requires massive doses of intravenous unfractionated     heparin. At end-CPB, residual heparin is neutralized with intravenous injection of protamine     sulfate. This prospective, randomized, controlled study will be conducted in 82 voluntary     subjects admitted for elective, first intention, cardiac surgery requiring cardiopulmonary     bypass. Each will be randomly assigned to one of two groups. The control group will be     submitted to a standard protamine infusion of 1.3mg :100U of the total heparin dose given     during bypass. The test group will receive an infusion of protamine (over 15 minutes) until     activated clotting time (ACT) values (determined every 3 minutes) depict a plateau, sign that     the optimal protamine to heparin ratio has been attained. The investigators hypothesize this     new in vivo titration method to be as efficient as the standard protocol (adequacy of heparin     neutralization, % heparin rebound, bleeding, and transfusion), and potentially safer by its     ability to prevent protamine overdose and its deleterious impact on platelet function.15      Principal Objective      Evaluate a new in vivo method of titration of protamine sulfate.      Secondary Objective      Evaluate the impact of this method on the adequacy of heparin neutralization by measuring:        1. platelet count        2. postoperative bleeding        3. transfusion exposure a        4. incidence of heparin rebound   "
216509|NCT00684463|"     The purpose of this study is to evaluate the efficacy and safety of single IV doses of     Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting     associated with moderate and highly emetogenic chemotherapy.   "
216510|NCT00684476|"     Maintenance venom immunotherapy administered at 6-month intervals to bee-venom allergic     patients failed to provide protection from systemic reactions after sting challenges. These     patients should continue their immunotherapy at 1-3 month intervals.   "
216511|NCT00684489|"     Plasma renin values determine whether volume or vasoconstrictor (renin) factors predominate     in elevating blood pressure and are useful in selecting effective antihypertensive     therapy.2,3      The researchers hypothesize that:        1. Plasma renin-guided therapeutics will improve systolic and diastolic blood pressure          control in patients with untreated hypertension as well as in patients with treatment          refractory or resistant hypertension that are managed by Clinical Hypertension          Specialists.        2. Renin-guided therapeutics will reduce the number of medications required to maintain          blood pressure control to <140/90 mmHg in hypertensive patients receiving 3 or more          medications, while under the care of a Clinical Hypertension Specialist.        3. Renin-guided therapeutics selection will reduce the total cost of antihypertensive care          provided by Clinical Hypertension Specialists.   "
216620|NCT00686114|"     This study is multi-center randomized phase III one to evaluate the difference in     local-control and survival rate between patients receiving concurrent chemoradiotherapy     combined Tarceva or not.   "
216917|NCT00690404|"     A open label two way crossover formulation and food effect study in healthy volunteers to     assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an     oral solution   "
216512|NCT00684502|"     The purpose of this study is to investigate the safety and tolerability of AZD2066 using     multiple escalating dose panels. There will be separate panels for young healthy volunteers     and elderly healthy volunteers. Each panel will contain 10 volunteers who will randomly     receive AZD2066 or placebo. One panel will be run at a time with a fixed dose given. After     the completion of each panel, a Safety Review Committee will decide if the study can proceed     to the next dose panel.   "
216513|NCT00684515|"     The study is designed to assess safety of Vorapaxar when added to standard of care (aspirin)     in Japanese subjects with cerebral infarction. The study will assess incidence and     tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on     expression of markers of inflammation.   "
216514|NCT00684528|"     Comparison between the effectiveness of one anti-diabetic drug (Metformin, To combination of     this drug and additional drug (Janufer), In the community setting.   "
216515|NCT00684541|"     Generalized Social Phobia is characterized by severe social anxiety that leads to functional     impairment (Schneider et al., 1992). Despite its high prevalence, many individuals do not     receive treatment or are unresponsive to current therapies. Thus there is a clear need to     continue to develop highly effective and efficient treatments for social phobia. This three     year project aims to test a computerized treatment for social phobia in a double-blind,     placebo-controlled study designed to modify interpretation biases that may maintain anxiety.   "
216516|NCT00684554|"     The study will assess the effectiveness of at-home vs. in-office induction for patients     entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care     clinic.   "
216517|NCT00684567|"     The purpose of this study is to evaluate the safety of combination therapy of radiotherapy     and temozolomide (concomitant radiotherapy phase), and then temozolomide monotherapy     (monotherapy phase), in patients with newly diagnosed glioblastoma multiforme. Progression     free survival and response rate will also be calculated.   "
216518|NCT00684580|"     Progress in the development of curative therapy for pediatric malignancies has resulted in     increasing numbers of long-term childhood cancer survivors. This protocol is a means to     provide continuing review of outcome and late toxicity for all patients actively being     treated and previously treated for childhood cancer at St. Jude Children's Research Hospital.   "
216519|NCT00684593|"     This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis     Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the     Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin,     and 4) to determine the multiple-dose pharmacokinetics of Navarixin.   "
216520|NCT00684606|"     The purpose of the present study is to evaluate the possible benefit of concurrent IV     Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.   "
216521|NCT00678054|"     This is a Phase II study to test the efficacy of exogenously administered GM-CSF in prostate     cancer patients who have failed definitive local therapy, and have only serologic (PSA)     evidence of progression.   "
216522|NCT00678067|"     To examine whether Docosahexaenoic Acid (DHA) and Docosahexaenoic + Eicosapentaenoic Acids     (DHA+EPA) supplementation in addition to National Cholesterol Education Program Step I Diet     in Hypercholesterolemic Children increases Docosahexaenoic Acid (DHA) plasma levels in the 2     intervention groups versus placebo. Secondary outcome measure: effect of DHA and DHA+EPA     supplementation on blood lipid profile   "
216631|NCT00686270|"     This study will examine the long term safety of apricitabine in HIV-1 infected patients from     studies AVX-301 or AVX-302. Eligible patients are those who have either (a)completed studies     AVX-301 or AVX-302; or (b)met the criteria for virological failure/lack of response, and     consequently wish to withdraw early from studies AVX-301 or AVX-302.   "
216523|NCT00678080|"     Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages,     birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range     decreases these pregnancy complications. We hypothesize that metformin will achieve similar     levels of blood sugar control compared to insulin. In doing so, metformin will prevent the     increased risk of pregnancy complications associated with T2DM in pregnancy. We propose a     pilot study of a randomized, controlled trial of metformin versus insulin in the treatment of     T2DM during pregnancy.   "
216524|NCT00678093|"     Mulligan's mobilisation techniques are believed to increase the range of movement (ROM) in     patients with low back pain. The primary aim of this study was to investigate the mechanical     effects of Mulligan's SNAG technique on lumbar flexion ROM. The secondary aim was to     measure the intra- and inter-day reliability of lumbar ROM employing the same procedure, and     utilising a 3-D motion analysis system for measuring range of motion (ROM).   "
216525|NCT00678106|"     Adolescent subjects hospitalized for the treatment of bacterial infections will be given 1     gram of dalbavancin through their veins and levels of dalbavancin in blood and urine will be     measured at different time points. Safety labs will also be checked on a regular basis to     assess the safety of dalbavancin.   "
216526|NCT00678119|"     Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in     combination with sunitinib in subjects with previously untreated advanced stage RCC.   "
216534|NCT00678236|"     The goal of this scientific study is to determine whether there are differences in early     migration and prosthesis-near bone density when a standard knee prosthesis is fixed with     Refobacin Bone Cement R or with Refobacin Plus Bone Cement. Migration will be evaluated with     RSA and bone density around the prosthesis with DEXA. The study will be successful if the     prosthesis is fixed and remains in place throughout the entire period of the study, that is,     that there is no increasing migration as measured by RSA. The cement type that ensures the     largest number of solidly fixed prostheses during the two-year evaluation period will be the     best.   "
216535|NCT00678249|"     This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients     with stenoses at the venous anastomosis of a synthetic AV access graft.   "
216654|NCT00686569|"     Postoperative anastomotic leakage is a serious complication in patients with oesophageal or     cardia cancer. Early diagnosis and treatment are mandatory. The primary aim of the present     study is to investigate the clinical use of mediastinal microdialysis and whether is able to     detect anastomotic leakage prior to the development of clinical symptoms.   "
216527|NCT00678132|"     Background:        -  AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a          protein that is involved in repairing DNA damage; PARP inhibitors interfere with that          process.        -  Cisplatin and gemcitabine are approved by the United States Food and Drug Administration          to treat certain cancers.      Objectives:        -  To determine the optimum doses of AZD2281, cisplatin and gemcitabine in combination that          can safely be given to patients with solid tumor cancers.        -  To evaluate the response of the tumor to the drug combination and determine the side          effects of the treatment.      Eligibility:      -Patients 18 years or older with an advanced solid tumor cancer for whom standard treatments     are not effective.      Design:        -  In this dose escalation study, the first small group of patients receives the smallest          study doses of the study drugs. Subsequent groups receive incrementally higher doses as          long as the preceding group does not experience unacceptable side effects. When the          highest safe dose is determined, additional patients entering the study receive that          dose.        -  Patients receive treatment in 21-day cycles as follows:        -  Days 1-4: AZD2281 by mouth twice a day        -  Day 3: gemcitabine thorough a vein over 1 hour; then cisplatin through a vein over 1          hour.        -  Day 10: gemcitabine through a vein over 1 hour.        -  Evaluations during treatment include the following:        -  Physical examination, vital signs check and blood tests every 3 weeks.        -  CT scans every 6 weeks to evaluate the tumor.        -  Treatment may continue until it is no longer beneficial.   "
216528|NCT00678145|"     Many studies have demonstrated that when people with diabetes are intensively treated with     insulin in order to maintain their glucose within the normal range, all the complications of     diabetes can be prevented or delayed. However, such treatment carries a significant risk of     severe hypoglycemia (excessively low blood glucose levels), which may be life-threatening.     Thus, ideal treatment with insulin in patients with diabetes can be seen as a double-edged     sword: intensive treatment will delay the complications but is also associated with an     increased risk of disabling hypoglycemia. In normal conditions, when hypoglycemia occurs, the     body responds by secreting a variety of hormones and by activating the autonomous nervous     system which ultimately will result in increasing the blood glucose to normal levels.     Patients with diabetes, lose this capacity to effectively respond to hypoglycemia and become     more susceptible to a fall in plasma glucose. Paradoxically, repeated episodes of     hypoglycemia—especially in the most vulnerable persons with type 1 who need insulin for     life--induce a metabolic deterioration that further increases the risk of developing     hypoglycemia.      Our proposal focuses on understanding the mechanisms the body uses in order to respond to     hypoglycemia and on potential tools (medicines) that may be used in order to prevent this     metabolic deterioration associated with repeated episodes of hypoglycemia.      Based on previous data generated in our laboratory (and others), we propose that repeated     episodes of hypoglycemia are associated with a deterioration in the body sensor for     hypoglycemia in diabetes. Moreover, since many studies have shown that such deterioration in     the response to hypoglycemia can be induced also by exercise (patients with diabetes are at     greater risk for hypoglycemia after exercise), we propose that exercise (and other stresses)     affect the hypoglycemia response by endorphin release (endorphins are proteins responsible     for inhibition of the neuroendocrine response system).      Developing a method that will decrease the incidence of severe hypoglycemia will result in     safer control of blood glucose, a decrease in the complications of diabetes, and ultimately     in a better quality and longer life for many patients with diabetes.   "
216529|NCT00678158|"     The purpose of this research study is to find out what IG-IMRT radiation dose works best for     treatment of disease in bone or soft tissues. This protocol will study what dose level may     work most effectively. The first part of study will treat 10 patients with 22 Gray. Gray (Gy)     is the unit that is used to describe the dose of radiation that is being given to a person     with cancer. After we confirm that 22 Gy is a safe and sufficient amount of radiation, we     will then treat another group of patients with 24 Gy and so on until we reach 28 Gy. Each     dose level starting with 24 Gy will enroll at least 20 patients per treatment site (bone,     bowel and/or spine). Patients will be enrolled in each treatment category until 20 patients     in each strata reach an evaluable time point of 3 months post-RT. When we understand what     dose works best and has the least amount of bad effects, the study will then look to see how     well the patients do after the radiation therapy. This study is trying to see how your doctor     can best treat the cancer that has spread to the other parts of your body.   "
216530|NCT00678171|"     This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of     single-level TLIF of the lumbar spine.   "
216531|NCT00678184|"     We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium     handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans     during normal and high sodium intake.   "
216542|NCT00678340|"     Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF     occurs in up to 10% of the population over the age of 60. It is associated with tiredness,     impaired functional capacity and is the cause of up to 10% of strokes.      Ablation is a procedure performed with small tubes (catheters) that are introduced through     the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been     shown to cure 90% of patients with intermittent (paroxysmal) AF.      The investigators currently use either one of two different catheters to create these burns     inside the heart. The investigators do not know which is the best catheter to use in patients     with paroxysmal atrial fibrillation.      The investigators study will randomly allocate patients to have their ablation performed by     either one of the catheters to give a fair comparison between the two. The investigators     objective is to study the differences between these two catheters.   "
216532|NCT00678197|"     The long-term consequences of poverty on child health, including cognitive development, are     one of the world's great tragedies. In the Philippines, diarrhea, acute lower respiratory     infections, and the attendant problems of malnutrition, are the leading causes of childhood     illness. The Philippine government plans to launch a broad national Health Sector Reform     Agenda (HSRA) that will address the problems of poverty and illness in children. The     introduction of these reforms provides an exceptional opportunity to conduct a social     experiment. Four institutions, already involved in the design and implementation of the HSRA,     plus leading experts in international health, government, and health measurement will     collaborate on this project to collect longitudinal data and measure the impact of HSRA     reforms on child health outcomes in a population. We will measure the health impacts of two     experimental interventions: (1) expansion of health insurance coverage, and (2) capitation of     providers. Our research will measure the impact of health reforms on the physical and     cognitive health outcomes of children age 0-4. We will use a block design of 21 sites     throughout the Philippines: seven for each of the two interventions, and seven matched     controls. We will measure the quality of clinical practice using vignettes and will measure     health outcomes using objective clinical tests. We will also use an advanced sampling     strategy and panel data to link clinical practice with population health outcomes. This     unparalleled research opportunity will yield significant insights about specific, unanswered     questions of tremendous importance: Does health care serve as a social intervention that     ameliorates the effects of morbidity and malnutrition on cognitive development? How effective     are government policies at creating incentives to improve the quality of clinical practice?     Do financial and organizational policies actually lead to better health and developmental     outcomes? The results from this study will provide insights into the linkages between     increased access, high quality care, and health outcomes in children.   "
216533|NCT00678210|"     The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3     dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic     plaque psoriasis.   "
216938|NCT00690677|"     The purpose of this study is to determine the effects of the study drug, LBH589, on patients     with metastatic colorectal cancer that has continued to grow despite previous treatment.   "
216536|NCT00678262|"     Abstract:      Pain, a subjective sensation, has been increasingly studied, as it has been recognized as an     important factor in patients' recovery and quality of life. Pain is charted today as one of     the vital signs. For standardization, pain is charted by a number from 0 to 10 indicating its     level. The most common practiced pain assessment tool today is the VAS- Visual Analog Score     (facial or numerical), by which the patient himself indicates the level of the pain he or she     endures. It has been found that the correlation between the reported pain by the patient and     the assessed pain by the caregivers or the medical personnel becomes poor as pain     intensifies.      Objective assessment of anesthesia using the heart rate and its spectral analyses was done in     the past. By using this modality, works on neonatal pain were conducted. In adults, works     have shown that there is possibility to assess pain using this modality, though no repeated     proof for its ability to detect pain was published.      We know that physiological signals such as ECG consist of mixtures of variety of patterns and     phenomena accruing at different patterns and time points. Traditional analysis methods are     designed and optimized to handle signals that include a single class of patterns such as pure     harmonics or piece-wise constant functions. However, such basic operations that use a single     representation method usually yield mediocre results when applied to real complex biological     signals as ECG and EEG especially in the case where the Signal to Noise Ratio (SNR) is very     low. Recent trends in digital signal processing (DSP) use the novel idea of merging several     different representation methods to create a so called over-complete dictionary, examples of     this approach include the Matching Pursuit algorithm and the Basis Pursuit algorithm. We     intend to develop and apply the novel signal processing tools to the ECG signals during     painful experience for the first time. We believe that such tools have the potential to     provide much better insight of the signal basic components and their relation to pain.   "
216537|NCT00678275|"     This multicenter, prospective phase III-study is to compare the administration of ATG     FRESENIUS to the NON-administration of ATG FRESENIUS in a myeloablative conditioning regimen     followed by allogeneic hematopoeitic stem cell transplantation from an HLA-identical sibling     in patients with acute Leukemia. This clinical trial is to show that the administration of     ATG FRESENIUS reduces the risk of chronic Graft-versus-Host disease after allogeneic stem     cell transplantation from HLA-identical siblings.   "
216538|NCT00678288|"     This study is to assess sorafenib as second treatment for patients that have previously     received only sunitinib as first-line treatment for advanced renal cell cancer, and who     either responded and then progressed with sunitinib or were intolerant to sunitinib. This     study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose     interferon (3 million international unit (MIU) five times a week) can treat kidney cancer     more effectively than the current approved dose alone and if it is safe. In addition, for     patients that respond to treatment with sorafenib alone or in combination with interferon     before progressing, patients may receive sorafenib alone at an increased dose of 300mg     twice-daily, provided that toxicities are acceptable and at the discretion of the     investigator.   "
216539|NCT00678301|"     The purpose of this study is to assess the immunogenicity in terms of antibody response and     the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse     events following primary vaccination of African Sub-Saharan infants with pneumococcal     conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell     pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4     months of life.   "
216540|NCT00678314|"     This study was done with the primary aim of assessing the efficacy (as calculated by pain     intensity difference) of patient controlled regional analgesia (PCRA) technique against oral     analgesics, which has been the standard of care at our hospital. Secondary objectives were to     analyze the volume and dose of LA that should be given, patient satisfaction and the     long-term outcome for patients treated with the PCRA technique.   "
216541|NCT00678327|"     RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before,     during, and after chemotherapy may help doctors assess a patient's response to treatment and     help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in     assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma.      PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it     works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage     III, or stage IV Hodgkin lymphoma.   "
216543|NCT00678353|"     This study is to provide additional data to support the safety and efficacy of OP-1 Putty as     a replacement for autograft in patients undergoing posterolateral spinal fusion.   "
216544|NCT00678366|"     The study intends to investigate the use of a novel gaz-composition used during laparoscopy     upon pain and inflammation in the post-operative period.   "
216545|NCT00678379|"     Tonsillectomy is associated with a significant decrease quality of life in children secondary     to pain, which is worsened with swallowing. The objective of the current study is to conduct     a prospective, double-blind, placebo-controlled, randomized clinical trial using a     pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in     reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline     injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) +     clonidine (25 µg).   "
216546|NCT00678392|"     The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in     delaying tumor progression in patients with metastatic renal cell cancer after failure of one     first line regimen.   "
216547|NCT00678405|"     The aim of this study is to evaluate the impact of a Breathlessness Intervention Service     (BIS) on the quality of life of patients and families affected by intractable breathlessness.     The questions to be addressed by this research are:        1. Is BIS more effective than standard care for patients with intractable breathlessness          from advanced malignant or non-malignant disease?        2. Does it reduce patient and carer distress due to breathlessness, and increase patients'          sense of mastery of the symptom?        3. What are the experiences and views of those who use BIS, their informal carers and the          clinicians who refer to it?        4. Does BIS offer value for money for the NHS?   "
216548|NCT00678418|"     This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of     VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon     discharge from inpatient treatment for opioid dependence.      The study was conducted in 2 parts, Part A and Part B. The clinical portion of both parts has     completed. Results for Part B are not yet available.   "
216599|NCT00684801|"     RATIONALE: A disease management program may be more effective than standard therapy in     improving quality of life and controlling symptoms in patients with cancer.      PURPOSE: This clinical trial is studying a disease management program to see how well it     works compared with usual care in patients with stage III or stage IV lung cancer, stage III     or stage IV pancreatic cancer, stage III or stage IV ovarian cancer, or stage III or stage IV     colorectal cancer, and their caregivers.   "
216549|NCT00678431|"     Alzheimer's disease (AD), one of the leading causes of morbidity and mortality in the elderly     is characterized by progressive cognitive decline and certain neuropathological features.      Currently, there is great interest in the well-documented mitochondrial (oxidative) lesion in     AD. Disturbed oxidative metabolism is a well described abnormality in AD. Several     observational studies have shown that moderate consumption of wine is associated with a lower     incidence of Alzheimer's disease (Truelsen et al., 2002; Luchsinger et al., 2004). Wine is     enriched in antioxidant compounds with potential neuroprotective activities. In the early     1990s the presence of Resveratrol in red wine was detected where it is suspected to afford     antioxidant and neuroprotective properties (Miller and Rice-Evans, 1995).      Blass and Gordon (2004) have demonstrated positive effects in AD with an oral preparation of     glucose, malate and resveratrol. Glucose is the physiological precursor of the substrates of     oxidative metabolism in the brain, malate is a primer of the energy-providing Krebs-cycle.     Glucose and malate therefore can provide reducing equivalents (electrons) to regenerate the     reduced form of resveratrol, and do so under the normal regulation of brain cell metabolism.     All three ingredients are classified by the FDA as Generally Recognized As Safe.   "
216550|NCT00678444|"     To compare patient satisfaction and anxiety scores between female subjects undergoing urinary     incontinence and/or pelvic reconstructive surgery who are instructed preoperatively in the     technique of clean intermittent self-catheterization (CISC) by means of an instructional     video and those who do not receive specific preoperative instruction in CISC, other than     basic informed consent regarding risks of postoperative urinary retention.   "
216551|NCT00678457|"     This study would like to test whether the combination of ondansetron and olanzapine will be     superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.   "
216552|NCT00678470|"     This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in     this 6 month study to evaluate whether the response to intralesional alefacept injections     prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes     in psoriasis patients. One lesion with a psoriasis severity assessment score greater than 3     and an induration score greater than 1 will be identified on each patient. Each lesion will     receive only one intralesional alefacept injection during the first three weeks of the study     (1 lesion per week). Following a 2 week observation period, subjects will undergo a standard     12 week course of weekly intramuscular alefacept injections. The Psoriasis Area Severity     Index (PASI) score will be used to determine the effectiveness of the intramuscular alefacept     treatments. An 8 week follow-up period will begin after the last dose of alefacept is     administered where safety and efficacy measures will continue to be monitored as outlined in     the study procedures. The hypothesis is that the response to intralesional alefacept     injections, whether it is positive or no benefit, will predict the clinical response to     intramuscular alefacept administration.   "
216553|NCT00678483|"     The primary objective of this study is to assess, over a period of 12 months, the effect on     weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in     overweight/obese patients after an initial treatment period of 6 months with rimonabant 20     mg.      Secondary objectives are to assess the effect of rimonabant over a period of 12 months on     waist circumference, high-density lipoprotein (HDL)-Cholesterol and triglycerides (TG),     fasting plasma glucose (FPG), fasting insulin and to evaluate the long-term safety and     tolerability of rimonabant 10 mg and 20 mg over a period of 12 months after randomization in     overweight/obese patients.   "
216579|NCT00678834|"     Levels of tocotrienol in human tissues following supplementation is not currently known. The     objective of this present study is to determine the levels of this form of vitamin E in the     human tissues such as skin, heart, lung, liver, adipose tissue, Brain and cerebrospinal fluid     (CSF) following oral supplementation   "
216595|NCT00684749|"     At a national level of 15%, the reoperation rate following augmentation mammaplasty is too     high. We are conducting a survey to examine the pre-operative methods by which plastic     surgeons determine implant volume, size, shape and location; and to determine if the Mentor     BodyLogicTM System can successfully improve outcomes. We will evaluate how measurements     taken using BodyLogicTM influence choice of implant and whether there are any     re-operations, particularly for size change. We hypothesize that using this system will help     surgeons choose appropriate implants that will decrease the rate of reoperations, especially     for size change.   "
216596|NCT00684762|"     The purpose of this study is to evaluate and compare the relative bioavailability of a test     formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after     a single oral dose administered under fasting conditions.   "
216554|NCT00678496|"     Guidance issued by the UK National Institute for Health and Clinical Excellence (NICE)     recommends the use of computerised cognitive behavioural therapy (CCBT) 'Beating the Blues'     (BtB) in treatment of depression. However CCBT has not been designed specifically for use by     people with Multiple Sclerosis (MS) and may not be effective or appropriate for use by people     with physical disabilities or cognitive symptoms. There would therefore be value in     conducting a trial of the effectiveness of CCBT for depression in people with MS. The aim of     this pilot study is to test the feasibility of a randomised control trial (RCT) of CCBT for     depression in people with MS. The objective is to undertake a pilot RCT of comparison of CCBT     with usual care including 3 month follow up to identify a realistic patient recruitment rate     and provide reliable estimates of other parameters needed for designing a definitive RCT     including the sample size. Other outcomes to be measured include estimates of the effect on     depression and quality of life. Participants will be assessed as experiencing clinical levels     of depression and be recruited from two participating MS Centres. The outcomes of the study     will be (1) preliminary indication of the impact of CCBT on depression in MS; and, (2) a well     researched protocol for a definitive RCT of the effectiveness of CCBT in treating depression     in people with MS.   "
216555|NCT00678509|"     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402     restricted epitope peptide TTK emulsified with Montanide ISA 51.   "
216556|NCT00678522|"     We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium     excretion, glomerular filtration rate, tubular function and vasoactive hormones in patients     with type II diabetes, not in treatment with insulin.   "
216557|NCT00678535|"     The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line     treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a     clinically relevant benefit for subjects with advanced gastric adenocarcinoma including     gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).      Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall     survival, overall tumor response, quality of life (QoL) and safety.   "
216558|NCT00678548|"     Chronic pain after spinal cord injury in or below the level of injury is a common problem and     can be severe.      The purpose of our study is to investigate the effect of pleasant guided imagery on spinal     cord injured patients with chronic pain in or below the level of injury.   "
216559|NCT00678561|"     Study will test effectiveness of an experimental drug applied once or twice daily to two     psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.   "
216560|NCT00678574|"     The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the     pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring     cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance     spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and     post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®,     Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid     levels with cortical GABA levels at these same time points. Neurosteroids to be measured     include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with     PMDD will be compared to those of healthy subjects.   "
216561|NCT00678587|"     The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts     thereby reducing the need for platelet transfusions in chronic liver disease patients with     thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag     will be measured by the proportion of subjects who avoid platelet transfusions, before,     during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events     will be monitored during this time. The number of transfusions, safety events and medical     resource utilisation will be monitored during this time and for up to 30 days after     undergoing an invasive procedure to help further evaluate clinical benefit.   "
216562|NCT00678600|"     The purpose of this study is to determine whether alerts independent of the ambulatory health     record are more effective in eliciting physician responses and therefore have greater impact     on HIV disease outcomes than traditional static alerts.   "
216563|NCT00678613|"     Cirrhotic patients are predisposed to bacterial infection. A large proportion of which is     spontaneous bacterial peritonitis(SBP), which are mainly caused by enteric bacteria.SBP in a     cirrhotic patients is associated with a high mortality rate in the order of 30-80% per     year.It has been demonstrated that cirrhotics who have an ascitic fluid protein concentration     less than 1gm% are most susceptible to develop SBP by virtue of having low opsonising     activity of ascitic fluid.Patients with liver cirrhosis have significant degrees of imbalance     of intestinal flora.Translocation of intestinal bacteria being the major mechanism for the     production of SBP.      Long-term antibiotic (norfloxacin) is very effective in preventing SBP caused by gram     negative bacteria.But the problem with the long-term antibiotic prophylaxis is the potential     for the development of infection with antibiotic-resistant bacteria.Further, quinolones have     no effect on gram positive bacteria which is becoming one of the important cause of SBP.      Such experiences necessitate the need for strategies, other than antibiotic, to prevent     intestinal bacterial overgrowth, bacterial translocation and SBP in patients with     cirrhosis.Probiotics have been used successfully to alter the gut flora in many clinical     conditions where growth and localization of non pathogenic bacteria replaces the pathogenic     bacteria in the intestine.The probiotic bacteria, among which the most common are the lactose     fermenting Lactobacilli, inhibit the growth of pathogenic bacteria by acidifying the gut     lumen, competing for nutrients, and by producing antimicrobial substances. They adhere to the     gut mucosa and by that are thought to prevent bacterial translocation from the gut.      The purpose of this study is to determine the effectiveness of probiotics in the prevention     of spontaneous bacterial peritonitis in patients with cirrhosis with low protein ascites and     those already have developed an episode SBP.   "
216564|NCT00678626|"     This study will assess the effectiveness of CP- 751,871 when given in combination with     docetaxel to women with the first occurrence of advanced breast cancer disease. The     effectiveness will be measured by progression-free survival duration. Patients will be     followed for 2 years from the date of randomization.   "
216565|NCT00678639|"     The purpose of this study is to investigate the best way to evaluate patients with chest pain     in the emergency department. It compares receiving treatment in an observation unit with     admission to the hospital. Patients treated in the observation unit will undergo cardiac     Magnetic Resonance Imaging (MRI) testing. Patients treated with hospital admission will     undergo the testing their doctor determines is best for them. All patients will undergo     follow up to find out if they have had any heart related events.   "
216566|NCT00678652|"     The purpose of this study is to determine whether a vaccine based on outer membrane vesicles     (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a     vaccine. If so, the NOMV in this vaccine will be combined with NOMV from two other     genetically modified strains as a potentially globally effective vaccine against group B     meningococcus.   "
216567|NCT00678665|"     Pain, a subjective sensation, has been increasingly studied, as it has been recognized as an     important factor in patients' recovery and quality of life. Pain is charted today as one of     the vital signs. For standardization, pain is charted by a number from 0 to 10 indicating its     level. The most common practiced pain assessment tool today is the VAS- Visual Analog Score     (facial or numerical), by which the patient himself indicates the level of the pain he or she     endures. It has been found that the correlation between the reported pain by the patient and     the assessed pain by the caregivers or the medical personnel becomes poor as pain     intensifies.      Objective assessment of anesthesia using the heart rate and its spectral analyses was done in     the past. By using this modality, works on neonatal pain were conducted. In adults, works     have shown that there is possibility to assess pain using this modality, though no repeated     proof for its ability to detect pain was published.      We know that physiological signals such as ECG consist of mixtures of variety of patterns and     phenomena accruing at different patterns and time points. Traditional analysis methods are     designed and optimized to handle signals that include a single class of patterns such as pure     harmonics or piece-wise constant functions. However, such basic operations that use a single     representation method usually yield mediocre results when applied to real complex biological     signals as ECG and EEG especially in the case where the Signal to Noise Ratio (SNR) is very     low. Recent trends in digital signal processing (DSP) use the novel idea of merging several     different representation methods to create a so called over-complete dictionary, examples of     this approach include the Matching Pursuit algorithm and the Basis Pursuit algorithm. We     intend to develop and apply the novel signal processing tools to the ECG signals for the     first time. We believe that such tools have the potential to provide much better insight of     the signal basic components and their relation to pain.   "
216600|NCT00684814|"     The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem     tartrate tablets to an equivalent oral dose of the commercially available reference drug     product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions.   "
216568|NCT00678678|"     Objective: To compare the effects of the EPAP and the incentive spirometry flow-oriented in     the pulmonary function after bariatric surgery.      Method: Twenty-eight women, non-smokers, with no lung disease and BMI of 35-49,99 kg/m2,     undergoing bariatric surgery by laparoscopy, were studied. Before surgery the patients were     divided in two groups: Spirometer Group (SG) (n=13) and EPAP Group (EG) (n=15). Pulmonary     function was evaluated by spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion,     on the preoperative and on the second postoperative day. Physiotherapy started on the day of     surgery, each modality (incentive spirometry or EPAP) performed lasting 15 minutes. The     deambulation and active exercises of upper and lower limbs were standardized for groups.   "
216569|NCT00678691|"     Armodafinil (NuvigilTM) is an isomer of a drug currently approved by the FDA for the     treatment of fatigue secondary to narcolepsy, sleep apnea, and shift work sleep disorder     called modafinil (ProvigilTM). There is considerable off label evidence for modafinil's     ability to reduce fatigue related to multiple sclerosis, Parkinson's disease, cancer related     fatigue, and depression related fatigue. There are preclinical studies showing that modafinil     can alleviate fatigue secondary to medication side effects (diazepam, chlorpromazine). This     multi-layered evidence base suggests that modafinil may be able to alleviate fatigue     regardless of medical illness. Armodafinil now has four completed Phase III FDA regulatory     studies revealing that it is well tolerated and effective for fatigue associated with     obstructive sleep apnea (Effects of Armodafinil in the Treatment of Residual Excessive     Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea Syndrome: A 12-Week, Multicenter,     Double-Blind, Randomized,Placebo-Controlled Study in nCPAP-Adherent Adults. Thomas Roth et     al. Clinical Therapeutics/Volume 28, Number 5, 2006), shift work sleep disorder, and     narcolepsy. Armodafinil is not yet FDA approved. It is felt to be a cleaner, safer, more     potent isomer. Theoretically, fatigue is interpreted and possibly dictated centrally and     armodafinil's proposed mechanism (similar to that of modafinil) of elevating central     histamine activity may allow the brain to interpret a lower fatigue state, thus allowing     patients to function better during the day with less peripheral fatigue.      Fibromyalgia (FM) is an illness that may involve medical, rheumatological, autoimmune, sleep,     endocrine and psychiatric pathology. It is a syndrome of recurrent pain at trigger points.     Greater than 90% of these patients will report fatigue as a key symptom as well. There are     several investigation lines into the treatment of FM induced pain. Exercise, behavioral     therapy, amitryptiline, duloxetine, tramadol, sodium oxybate all have randomized trials and     almost all focus on pain. There are very few studies, if any, that look at FM induced fatigue     which certainly ads to FM patients' daily incapacity and lowered productivity/quality of     life.      Armodafinil is a drug with minimal adverse effects (headache, insomnia, GI distress, anxiety,     dry mouth, dizziness and an assumed low level addiction which is comparable to modafinil)     which is well tolerated in current regulatory studies. It may have a safer tolerability     profile than the FM medications noted above. As modafinil is often studied and often added as     an augmentation agent to patients' regimens who suffer from fatigue in other medical     illnesses, the authors feel that armodafinil would also be effective in this population. The     authors wish to conduct a study to determine if armodafinil is safe and tolerable in the     treatment of FM induced fatigue. This initial controlled study may allow for continued     regulatory studies with this product in FM subjects. We propose a double-blind placebo     controlled study to determine if armodafinil is safe and effective in reversing FM induced     fatigue.   "
216570|NCT00678704|"     The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was     confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was     no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg     regimens. Overall the tolerability was considered good with both regimens.   "
216571|NCT00678717|"     The purpose of this study is to assess the effect of the spinal cord stimulator (A small wire     is surgically implanted under the skin. Low-level electrical signals are then transmitted     through the lead to the spinal cord to alleviate pain. Using a magnetic remote control, the     patients can turn the current on and off, or adjust the intensity.) on the autonomic nervous     system (sympathetic and parasympathetic). Some studies support that the spinal cord     stimulation suppresses or decreases sympathetic outflow (the sympathetic nervous system is     the one that provide us with the flight and fight response and the parasympathetic nervous     system is the one that works while we sleep, rest and digest.). The sympathetic nervous     system is important in blood pressure regulation also. However, there are not reports     regarding the effect of the spinal cord stimulation on blood pressure regulation in chronic     visceral pain patients. Most clinical trials are focus on the effect of the spinal cord     stimulation on pain relief. We think we could use blood pressure, heart rate and special     analysis of these signals and their relationship to other pain measurements to assess the     effect of the spinal cord stimulation in an objective way.   "
216572|NCT00678730|"     This study attempts to examine genetic influences on the effects of tetrahydrocannabinol     (Δ9-THC), the active ingredient of marijuana, cannabis, ganja, or pot.   "
216573|NCT00678743|"     The primary objective of this trial is to assess the continued efficacy of Omacor     co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol     (non-HCL-C) levels.   "
216574|NCT00678756|"     Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected     psoriatic skin   "
216575|NCT00678769|"     This phase I trial studies the side effects and best dose of cixutumumab and temsirolimus in     treating patients with locally advanced or metastatic cancer. Monoclonal antibodies, such as     cixutumumab, can block cancer growth in different ways. Some block the ability of cancer     cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. Temsirolimus may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may kill more     cancer cells.   "
216576|NCT00678782|"     To assess the therapeutic efficacy, of the clinical response of intraarticular (IA)     etanercept (E) 12.5 mg or placebo (P: NaCl) injections into single knee arthritic joint of     patients with refractory knee joint synovitis (KJS), administered once every two week, for     eight weeks, with cross over after 2 weeks, in two groups of randomly assigned patients, for     whom traditional systemic disease-modifying antirheumatic drugs (DMARDs) is insufficient or     inappropriate. The primary outcome measure is the Thompson articular index of KJS disease     activity.   "
216577|NCT00678795|"     The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in     reducing the daily number of episodes on incontinence.   "
216578|NCT00678821|"     This study will determine if a rehabilitation exercise program can help people with pulmonary     hypertension (PH) increase their physical activity. Patients with PH have an increase in     blood pressure in the pulmonary blood vessels (artery, vein or capillaries) that leads to     shortness of breath, dizziness, fainting and other symptoms.      Healthy volunteers and people with pulmonary hypertension between 21 and 75 years of age may     be eligible for this study.      All participants undergo the following tests and procedures:        -  Medical history and physical examination        -  6-minute walk test: Subjects walk as fast as they can for 6 minutes on a walking track          to determine their ability to participate in physical activity.        -  Questionnaires: Subjects complete nine questionnaires related to their fatigue, daily          physical activity, mood, and so forth.        -  Maximum treadmill test: The exercise begins at an easy level and gradually increases          until the subject says he or she can no longer continue or the investigator decides it          is not safe to continue. Subjects are fitted with a mask, electrodes and light sensors          to measure how well the heart is working and how well the muscles use oxygen.      Patients with pulmonary hypertension undergo the following additional procedures:        -  Activity monitoring: Patients wear a monitor for 3 days that measures movement and heart          rate.        -  Group assignment: Patients are randomly assigned to Group 1 (education plus aerobic          exercise) or Group 2 (education followed by exercise).        -  Group 1 patients will attend classes three days a week at either Inova Fairfax Hospital          Pulmonary Rehabilitation Center or The National Institutes of Health for 10 weeks. Two          sessions a week will include a 1 hour education session as well as a 30-45 minute track          or treadmill exercise session. The third session will only include exercise. During the          education patients will learn about a healthy lifestyle with pulmonary hypertension.          After the 10 weeks of education and exercise, subjects repeat the 6-minute walk test,          maximum treadmill test and questionnaires.        -  Group 2 patients participate in 2; 1-hour educational session at either the Inova          Pulmonary Rehabilitation Center or The National Institutes of Health for 10 weeks. After          the classes, they repeat the 6-minute walk test, maximum treadmill test and          questionnaires. The following 10 weeks will consist of 3 days a week of 30-45 minute          track or treadmill walking at either Inova or NIH, after which they again repeat the          questionnaires, treadmill and walk tests.   "
216601|NCT00684827|"     The purpose of this study is to compare the safety and tolerability of levalbuterol HFA     metered dose inhaler (MDI) versus racemic albuterol HFA MDI.   "
216602|NCT00684840|"     The purpose is to study the extent to which stress and other factors, including money, the     amount of drug available and the amount of work effort, affect drug choice.      This study will assess whether exposure to yohimbine, a drug stressor, increases opioid     craving- and -seeking behavior. We will determine whether these behavioral outcomes are     associated with biobehavioral stress markers: increased saliva cortisol levels,     cardiovascular response (heart rate and blood pressure), and negative mood state.   "
216603|NCT00684853|"     The purpose of this study is to determine the association of bevacizumab and PDT is safety     and effective in the treatment of exudative AMD   "
216604|NCT00684866|"     The purpose of this study is to compare the safety and tolerability of levalbuterol HFA     metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years     of age with asthma   "
216983|NCT00691288|"     The overall objective of this study is to evaluate the safety and efficacy of fish oil     omega-3-fatty acid supplementation in treating pediatric HAART-associated     hypertriglyceridemia.   "
216580|NCT00678847|"     Indication: Subjects with chronic venous leg ulcers      Primary Objective:      • To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic     venous leg ulcers      Secondary Objective(s):        -  To evaluate the percentage of wound healing every two weeks        -  To evaluate the complete ulcer healing every two weeks        -  To evaluate the time to complete ulcer healing        -  To evaluate the recurrence rate at the end of the follow-up period        -  To evaluate pain        -  To evaluate the quality of life      Study Design and Treatment Scheme:      This is a Kingfisher Healthcare NV sponsored, national, multicenter, randomized, prospective     study in which data will be collected of subjects with chronic venous leg ulcers receiving     standardized conventional therapy (SCT). Subjects will be randomized into two groups     receiving SCT + placebo or SCT + bio-electrical stimulation therapy (BEST) to evaluate the     effect of BEST on the wound healing process.      Patients answering the eligibility criteria will receive standardized conventional therapy     during 4 weeks before actual study start and will then again be evaluated on eligibility     according to wound healing rate. Only patients with a wound surface that has not     significantly changed (both increased or decreased) will be randomized in the treatment     period.      During the treatment period patients will receive SCT with placebo or SCT in combination with     bio-electrical stimulation therapy on a daily basis for two hours, during 8 weeks.      Patients will be in follow-up period for a maximum of 8 weeks after treatment period.   "
216581|NCT00678860|"     This study will test and compare computerized and paper versions of eye questionnaires.     Questionnaires are used in medicine to gain a better understanding of how a disease can     impact a person's quality of life. Computerized versions of such questionnaires are often as     good as or better than paper versions, but there has been no direct comparison of the two.     This study may help in the development of eye questionnaires used to understand symptoms and     monitor patients in clinical trials.      People 21 years of age and older with ocular surface disease (OSD) and matched control     subjects without OSD may be eligible for this study. All participants undergo the following     procedures:        -  Medical and eye history.        -  Vision test and examination of the front part of the eye.        -  Tear measurement: A small piece of paper is placed on the surface of the eye to measure          the amount of tears produced. The consistency of the tears is measured by looking at how          fast they evaporate from the surface of the eye.        -  Completion of either paper-based or computer-based version of a questionnaire 15 minutes          after the eye examination and completion of the other version within 1 week at home.          (Subjects who complete the paper version in the clinic are told how to access the          computer version online at home or on a library computer; those who complete the          computer version in the clinic are given a paper version to take home.)   "
216582|NCT00678873|"     The investigators aim to investigate the safety, feasibility and short-term outcomes of     Single Incision Laparoscopic Cholecystectomy.      The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and     feasible.   "
216583|NCT00678886|"     The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads     to greater improvement in insulin secretion as compared with placebo infusion. Insulin     secretion will be assessed using mixed meal-stimulated C-peptide.      Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3     otelixizumab, 1/3 placebo). These study agents will be administered as an addition to     insulin, diet, and other physician determined standard of care treatments.      DEFEND-1 is now closed to enrollment.      DEFEND-2 will begin early in 2010. It is very similar to DEFEND-1 and will again require     subjects with new onset type 1 diabetes. Please check back here for more details.      In the meantime, established and new onset type 1 diabetes patients in North America are     welcome to consider the TTEDD study:      http://www.clinicaltrials.gov/ct2/show/NCT00451321?term=TTEDD&rank=1   "
216584|NCT00678899|"     The purpose of this study is to evaluate the safety and efficacy associated with the     provision of acoustic and electric sound processing to individuals who demonstrate     significant residual low-frequency hearing and profound high-frequency (above 1500 Hz)     sensorineural hearing loss. Delivery of acoustic-electric stimulation will be provided by the     Nucleus Hybrid L24 cochlear implant system.   "
216585|NCT00684619|"     The purpose of this study is to determine whether Nelarabine is effective in the treatment of     patients with T-ALL/NHL in order to achieve a complete remission followed by an early stem     cell transplantation.   "
216586|NCT00684632|"     This study is designed to determine whether KW-2246 is superior to placebo and not inferior     to immediate-release morphine for the relief of breakthrough pain in cancer patients.   "
216587|NCT00684645|"     Primary objective: to increase knowledge about safety, tolerability, quality of life and     efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment     response, hypothyroidism prevalence.The efficacy will be assessed using the Objective     Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance     data.   "
216588|NCT00684658|"     The purpose of the study is to compare the effects of a 5-week internet-based coping skills     training program (TeenCope) with a 5-week internet education program (Managing Diabetes) in     youth (age 11-14) with type 1 diabetes on intensive insulin therapy.   "
216589|NCT00684671|"     Only subjects who participated in the primary study will be invited to participate in the     extension phase and the challenge dose phase of this study.   "
216590|NCT00684684|"     The purpose of this study is to evaluate the safety and feasibility of the Chartis System in     measuring air flow and pressures in isolated lung compartments during bronchoscopy.   "
216591|NCT00684697|"     Premature infants with iron deficiency if supplemented with more elemental iron than the     routine 2mg/kg/day will have improved brain development.   "
216592|NCT00684710|"     This study will provide an initial assessment of the safety, tolerability, and     pharmacokinetics (PK) of PAZ-417 after administration of ascending single oral doses to     healthy young Japanese male and healthy elderly Japanese male subjects.   "
216593|NCT00684723|"     The purpose of this study is to evaluate and compare the relative bioavailability and     therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent     dose of Mevacor® tablets after a single oral dose administered under fed conditions.   "
216597|NCT00684775|"     The purpose of this study is to determine whether employment-based naltrexone treatment     proves effective in promoting depot naltrexone adherence and drug abstinence.   "
216605|NCT00684879|"     This study will explore the factors that influence screening behaviors of adults diagnosed     with hereditary hemorrhagic telangiectasia (HHT), an inherited condition in which blood     vessel defects called arteriovenous malformations (AVMs) result in direct connections between     arteries and veins. Patients most commonly have small AVMs called telangiectases on the     tongue, face, hands, mouth, and throat and the mucosal linings of the nose and     gastrointestinal tract. Recurrent nosebleeds are a hallmark of the disease. Large AVMs can     also occur in various organs, causing sudden and life-threatening complications.      The study will examine how patients think and feel about their condition and what actions     they take to screen for internal symptoms of the disease.      Men and women 18 years of age and older who have HHT may be eligible for this study.     Participants fill out a 30-minute questionnaire, available in print or online, that includes     questions about the participant s        -  beliefs about HHT        -  actions taken to screen for internal symptoms of HHT        -  experience with HHT        -  current health status, family history and demographic information   "
216606|NCT00684892|"     The purpose of this study is to evaluate the safety and feasibility of the Chartis System in     measuring air flow and pressures in isolated lung compartments in emphysema patients prior to     endobronchial lung volume reduction (ELVR).   "
216607|NCT00684905|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such     as leuprolide and bicalutamide, may lessen the amount of androgens made by the body. Implant     radiation therapy kills tumor cells by placing material such as radioactive iodine directly     into or near a tumor. Giving leuprolide and bicalutamide together with implant radiation     therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving leuprolide and     bicalutamide together with implant radiation therapy and to see how well it works in treating     patients with locally recurrent prostate cancer after external-beam radiation therapy.   "
216608|NCT00684918|"     This protocol will evaluate the efficacy of obatoclax in older patients with previously     untreated AML.   "
216609|NCT00684931|"     The aim of this study is to investigate the integrity of connectivity between the neocortex     and the cerebellum in the Attention Deficit Hyperactivity Disorder (ADHD). Fibers integrity     will be measured using magnetic Resonance Imaging Techniques.   "
216610|NCT00684944|"     This is an open label, dose-ranging study of two doses of TRx0014 in patients with mild or     moderate Alzheimer's Disease. The trial is made available to any patient ongoing on treatment     in the clinical trial designated TRx-014-001 at termination of that study. Treatment for each     individual patient will continue for as long as the treating physician feels there is benefit     to the patient. This current protocol covers each patient for 12 months in the first     instance.   "
216611|NCT00685997|"     Background:      The malignant lymphomas, Hodgkin´s disease (HD) and non-Hodgkin´s lymphoma (NHL), comprise     approximately 5-6% of all malignancies in adults and account for 10% of childhood cancers.     Once the diagnosis has been established histologically, extent of disease (staging) and     response to therapy will be assessed by means of a computed tomography (CT) scan of the body.     The staging at presentation is important for determining prognosis and choice of treatment.     Unfortunately, CT is accompanied by a significant amount of radiation exposure which may     induce second cancers. This is especially important in childhood, because rapidly dividing     cells are more sensitive to radiation induced effects and children will have more years ahead     in which cancerous changes might occur. New magnetic resonance imaging (MRI) techniques offer     an alternative way for staging and follow-up of cancers, including the malignant lymphomas.     Whole-body MRI (WB-MRI) is a radiation-free method which allows imaging of the body with     excellent soft tissue contrast in a single examination.      Purpose:      The aim of this study is to examine if WB-MRI can replace CT in staging of patients with a     malignant lymphoma.      Design:      This will be a multicenter, prospective, diagnostic cohort study (timeschedule: 36 months).     135 eligible patients will undergo WB-MRI on top of the protocolar imaging routinely done.      Study population:      Patients aged 8 years and older with a histological diagnosis of HD or NHL.      Statistical analysis:      The challenge of this study will be to show non-inferiority of WB-MRI compared to CT in     staging malignant lymphoma. Testing of this hypothesis will be one-sided and performed using     recently proposed techniques by Lui et al.      Radiation-related risk assessment:      A risk model will be used, based on the BEIR VII report, for modelling the late-term     mortality from radiation induced tumors after exposure to ionizing radiation.      Economic evaluation:      Actual costs (from a societal perspective) will be determined for the two diagnostic tests.     In case of clinical equivalence and similar costs or cost savings associated with MRI the     latter can be considered dominant, obviating further economic evaluation. Otherwise, through     modelling of expected long term health impact and associated outcomes such as quality of life     and costs the incremental cost effectiveness will be evaluated.   "
216612|NCT00686010|"     To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C     and on the inhibition of CETP activity versus placebo, in patients presenting with mild     dyslipidaemia. These objectives will be tested after 4 weeks of treatment.   "
216613|NCT00686023|"     Hypothesis: Inflatable intra medullary femoral nailing is superior to DHS in terms of blood     loss, operative complications and postoperative rehabilitation in the management of     pertrochanteric femur neck fractures.   "
216615|NCT00686049|"     The goal of this study is to assess the reliability of the HIV      Treatment Readiness Measure (HTRM) to assist clinicians in:      (1) determining whether or not youth living with HIV are ready to initiate HAART and (2)     identifying youth who may be in need of additional support services to facilitate their     adherence to HAART. The current study will examine the psychometric properties of the HTRM     and establish its test-retest reliability over a two week period. If the HTRM is found to be     reliable, a subsequent study will examine its predictive validity.   "
216616|NCT00686062|"     This is a randomized study of an interactive, computerized descision-assisting tool for     prenatal testing decision making (PT Tool) versus standard educational booklets distributed     to all pregnant women by the State of California (control). We hypothesize that, compared to     controls, women randomized to view PT Tool will have greater knowledge about prenatal testing     and its potential outcomes and better risk comprehension, and that they will be more     satisfied with the intervention and have lower decisional conflict.   "
216617|NCT00686075|"     Primary objective of this study is to describe the safety and tolerability of multiple doses     of MEDI-534 in children 6 to less than (<) 24 months of age and in infants 2 months of age.   "
216618|NCT00686088|"     The purpose of this study is to determine the therapeutic activity of different     concentrations of PRX302 at increasing volumes and/or number of deposits per gram of     prostate. Therapeutic activity will be determined based on changes in PSA levels, PSA     velocity, PSA doubling time and tumor burden following treatment.   "
216619|NCT00686101|"     This proposed 2-year questionnaire study examines views and attitudes regarding health risks     of cigarette smoking, smoking patterns and motivators for cessation in smokers who suffer     from schizophrenia compared to a sample of smokers without a major psychotic disorder.   "
216621|NCT00686127|"     This trial is part of a larger, longitudinal study of symptoms that occur in the breast     surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop     pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a     lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women     who wear the lidocaine patch will report a decrease in pain and decreased interference with     function compared to women who wear the placebo patch.   "
216622|NCT00686140|"     A double-blind, randomized, placebo-controlled trial of celecoxib as an add-on therapy to     risperidone compared to risperidone plus placebo in the treatment of 200 treatment-naive     first-episode patients with schizophrenia. The study addresses an immune dysfunction     hypothesis of schizophrenia.   "
216623|NCT00686166|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed.      PURPOSE: This phase II trial is studying the side effects and how well giving oxaliplatin,     capecitabine, and cetuximab together with radiation therapy followed by surgery works in     treating patients with stage II or stage III rectal cancer.   "
216624|NCT00686179|"     The purpose of this study is to evaluate the effects on cardiac repolarisation of     supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped     as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using     moxifloxacin as positive control.   "
216625|NCT00686192|"     We hope to determine if supplementing the diet of women who habitually consume low levels of     calcium, with 1500 mg of calcium a day for three months will increase fat oxidation and     decrease fat storage. We will also measure concentrations of lipids, glucose, hormones and     enzymes associated with fat and carbohydrate metabolism to determine alterations and     mechanism of the metabolic changes.   "
216626|NCT00686205|"     To test blood samples from volunteer donors of whole blood and blood components using a new     investigational test that detects human immunodeficiency virus (HIV) infection. Results will     be compared to the current HIV screening assay.   "
216627|NCT00686218|"     RATIONALE: Panobinostat and imatinib mesylate may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when     given together with imatinib in treating patients with previously treated chronic phase     chronic myelogenous leukemia.   "
216628|NCT00686231|"     The radial artery, which is located on the outer side of the forearm, can be used in     interventional procedures, such as cardiac catheterization, to provide access to the arterial     blood supply. In order to facilitate successful catheterization of the artery, a dilated     artery and one free of arterial spasm is desirable. The proposed study will randomize twenty     three healthy subjects to determine the effect of topical nitroglycerin on radial artery     vasodilation. In the first phase of the study, which is a dose escalation study, each subject     will receive either one or two inches of nitroglycerin in a blinded manner on one wrist and     placebo on the other. Radial artery diameter will be measured with ultrasound at regular     intervals up to two hours. The subjects will then return at a later date at which point they     will receive the alternate dose on one wrist and placebo on the other. In the second phase of     the study, we will randomize the same patients to a mixture of topical nitroglycerin and     lidocaine or topical lidocaine alone. Measurements of radial artery diameter will be     performed as in the first study.   "
216629|NCT00686244|"     Prospective, randomized, single center, controlled intervention study to investigate the     effect of a systematic combined personal and IT-based training on the outcome of patients     with metabolic syndrome.   "
216630|NCT00686257|"     The purpose of this study is to compare the Total Face Mask™ (Respironics, Inc., Pittsburgh,     PA) (covering whole face) and the standard oronasal facemask (covering nose and mouth) for     the emergency treatment of patients with acute respiratory failure with the machine blowing     air into the mask placed on the face (noninvasive positive pressure ventilation) (NPPV).   "
216632|NCT00686283|"     This study aims to determine the likely benefits of a study that would use the novel     techniques both of writing an exercise prescription and of including the family and/or     community in sticking to the exercise prescription by youths with diabetes, who often suffer     eventual cardiovascular complications that might be lessened by the exercise.   "
216633|NCT00686296|"     To evaluate wound healing with the use of Taliderm™ dressing and compare it to wet to dry     dressing in the treatment of open wounds after incision and drainage.   "
216634|NCT00686309|"     Asthma is a major health problem worldwide. The measurement of fractional exhaled nitric     oxide (FENO) has been established as a valuable non invasive and simple tool in the diagnosis     of asthma and may also act as a useful surrogate inflammatory marker on which to base     treatment decisions in asthma management algorithms. The measurement is useful also in other     respiratory diseases. Current methods of measuring FENO include on line measurements by heavy     duty expensive analyzers which are not widely and easily available. Off line measurements of     breath samples which can be analysed later may be a simple solution. We hypothesize tha toff     line measurements of NO will be as reliable and valid as those measured on-line   "
216635|NCT00686322|"     Present study is to investigate efficacy and toxicity profiles of induction one cycle of     paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2     cycles of PC consolidation chemotherapy.   "
216636|NCT00686335|"     The purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the     efficacy and safety of modified release Prednisone on signs and symptoms.   "
216637|NCT00686348|"     To assess the safety and effectiveness of Somatuline® Depot (lanreotide) Injection when     administered by a health care professional (HCP), the patient, the patient's partner or     parent/guardian as part of their routine acromegaly care.   "
217029|NCT00691886|"     To achieve safe,consistent, continuous sedation using Dexmedetomidine in advaced bronchoscopy     procedures that may reduce the need for rapid pain sedative infusion.   "
216638|NCT00686361|"     Cystic Fibrosis (CF) is a complex disease with a wide range of clinical problems. Despite     enzyme replacement therapy, children with cystic fibrosis (CF) may still have problems     absorbing some nutrients. Detailed studies of the nutrient status of children with CF and     have found low amounts of choline, an essential dietary nutrient, and altered levels of some     amino acids in almost all patients. Choline is an essential dietary nutrient that is     important in many important body functions, which include proving a source of methyl groups,     the structure of cell membranes and in acetylcholine. Most choline is present in our diets in     a fat known as phosphatidylcholine. Research studies have shown that children with cystic     fibrosis do not absorb fat, including phosphatidylcholine very well. In previous studies, we     showed that choline provided as a dietary supplement for 2 weeks improved choline status in     children with cystic fibrosis.      The purpose of this research is to find out if choline supplements over a longer duration of     6 months will improve and maintain normal choline status in children with CF.   "
216639|NCT00686374|"     Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated     Clinical Response in M06-806.   "
216640|NCT00686387|"     The purpose of this study is to establish a Brain and Spinal Tumor Tissue/Specimen repository     to serve as a resource for current and future scientific studies.   "
216641|NCT00686400|"     Environmental risk factors for the development of schizophrenia include infections during the     perinatal period or later in life with Toxoplasma gondii (TG) being one of the candidate     agents. A recent review (Torrey and Yolken, 2003) on TG in schizophrenia and other serious     mental disorder reported higher antibodies to TG in patients compared to controls in 18 of 19     studies, one having been conducted by the investigators group. In a second, independent study     on first-episode schizophrenia (n=56) and control subjects (n=32), sera were sampled and     standard instruments used to assess diagnoses and psychopathology, respectively to screening     controls.      For the total sample, contacts with animals during pregnancy and age emerged as a     non-significant predictors of TG IgG titers. Means of patients' and controls' TG IgG titers     did not differ significantly but variances did; a subgroup of patients' titers reached much     higher levels than those of controls. Patients in the high TG IgG subgroup were older     (p=0.001), also they were older when psychiatric symptoms appeared, more individuals had     regular animal contacts during pregnancy, or rural upbringing including regular animal     contact, more consumption of raw meat, and a higher absolute treatment response (all trend     levels). Regarding the short term course of patients, the investigators detected decreasing     IgG titers in several individuals A power analysis demonstrated that results fell short of     significance due to lack of statistical power. Based on the power analysis, the investigators     propose an opel label, multicenter study at three regionally different sites within Germany     (Halle, Hamm, Heidelberg). The investigators intent to study 173 first-episode patients with     schizophrenia, schizoaffective, and schizophreniform disorder and 173 matched controls.      The investigators hypothesize that - according to the heterogeneity of the illness - a     subgroup of patients will exhibit higher TG IgG titers compared to the remaining patients and     to controls; that this subgroup will have had regular contact with animals during pregnancy     and early life as well as developmental delays; and that clinical improvement, response to     treatment, and subjective well-being will run parallel with TG IgG decrease.      Patients shall be assessed on admission to hospital, at discharge and at 6- and     12-month-follow-up with respect to TG antibody titers, symptomatology, neuropsychology,     predictors of outcome, quality of life, and neurological soft signs. In controls two     assessments shall be performed, 12 months apart. All foreseen assessments will be performed     using standard measurement instruments with sound reliability and validity such as the SCID     and the PANSS. Exposure to cats, other warm-blooded life-stock, and raw meat will be assessed     using a special questionnaire.   "
216642|NCT00686413|"     The study is being performed in order to learn more about AZD3480 (potential as treatment for     patients with Alzheimer's Disease) and to investigate how much of AZD3480 is bound to the     nicotinic receptors in the brain at different concentrations of AZD3480 in blood, as well as     to investigate the period of time for this binding.   "
216643|NCT00686426|"     The goal of the current study is to determine the role of dairy in similarly preventing     weight and fat re-gain in obese adults who have successfully completed a weight loss diet     program.240 obese subjects will undergo a meal-replacement-based weight loss plan designed to     produce a 10 kg weight loss in 8-12 weeks. Upon achieving the weight loss goal, subjects will     be randomly assigned to either a low-dairy or high-dairy eucaloric weight maintenance diet     for two years. Macronutrient distribution will be maintained constant and set at     approximately the U.S. average. Primary outcomes include changes in body weight, body fat and     anatomical distribution of fat (via dual x-ray absorptiometry) and resting metabolic rate and     substrate oxidation (via respiratory calorimetry); Secondary outcomes include blood pressure,     circulating glucose, insulin, lipids and calcitrophic hormones. on prevention of weight     regain in humans has not yet been assessed in clinical trials.   "
216644|NCT00686439|"     We will conduct a pilot study of the effectiveness of adalimumab for inflammatory     osteoarthritis.   "
216685|NCT00686972|"     This study is being conducted to evaluate changes in sugar, metabolism, heart function and     changes in body composition as patients lose weight following bariatric surgery. The     investigators will compare improvements of the above changes as a function of the four     different types of bariatric surgery. The investigators believe the most beneficial and     safest procedure will be the Roux-en-Y.   "
216645|NCT00686452|"     Swimmers show the highest prevalence of asthma among elite athletes, certainly due to     chlorine exposure. The consequences of a chronic exposure to chlorine compounds by swimmers     and the mechanisms of asthme in this population are still poorly documented. Specific     diagnostic criteria have been proposed by the International Olympic Committee - Medical     Council (IOC-MC) and World anti-doping agency (WADA) to determine the presence of asthma in     athletes. Using the more specific bronchial provocation tests, our aims are        1. to compare the prevalence of asthma in swimmers and control subjects        2. to analyze the Influence of chlorine exposure on bronchial inflammatory processes in          swimmers versus control subjects        3. to study the time-course of changes in airway symptoms, responsiveness, inflammation and          remodeling after cessation of training   "
216655|NCT00686582|"     The objective of the current study is to show that the immune response of subjects previously     vaccinated with one or two doses of IMVAMUNE® can be boosted two years later with one     IMVAMUNE® vaccination. Assessment of individual antibody titers within short time intervals     following the booster vaccination will provide information on how fast and effective     measurable antibody titers can be reactivated.      In summary, this study is intended to confirm that a single dose of IMVAMUNE® can reactivate     antibody titers in subjects after being primed with one or two doses of IMVAMUNE®.   "
216656|NCT00686595|"     This study will evaluate the efficacy, tolerability, and effect on the quality of life of     infliximab in adults with moderate-to-severe psoriasis who are resistant to etanercept after     12 weeks of treatment or have failed 24 weeks of treatment with etanercept. Infliximab will     be administered as an intravenous infusion of 5 mg/kg at Baseline (Week 0), Visit 3 (Week 2),     Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).   "
216657|NCT00686608|"     The purpose of this study is to identify how certain parts of the brain that control appetite     respond to changes in dietary carbohydrate and fat.   "
216646|NCT00686465|"     Sometimes, cancer comes back after it has been successfully treated—a situation called     recurrent cancer. When recurrent cancer is suspected, the standard approach to diagnosis is     to perform a combination of imaging tests, such as x-rays, ultrasound, computed tomography     (CT), magnetic resonance imaging (MRI), and nuclear medicine scans. Sometimes, however, after     performing these tests it still may not be clear whether or not the cancer has come back.      Some studies have shown that a diagnostic imaging test called Positron Emission     Tomography/Computed Tomography (PET/CT) may be helpful in the diagnosis of recurrent lung,     breast, head and neck, ovarian or esophageal cancer or lymphoma. However, it is not clear if     PET/CT can offer better results than standard approaches to diagnosis.      This feasibility study is needed to determine how common it is for a diagnosis of recurrent     cancer to be unclear even after standard diagnostic imaging tests have been completed. If the     enrollment goal is reached (~60 patients enrolled in 18 months), a larger clinical trial is     being planned to determine if PET/CT is helpful in making the diagnosis of recurrent cancer     in situations where standard imaging tests have not been helpful. It is also expected that     the results of this feasibility study will help to define exactly which patients should be     enrolled in this larger clinical trial of PET/CT.   "
216647|NCT00686478|"     This study assesses the intervention with antifibrotic agents, specifically interferon (IFN)     to reduce the magnitude and duration of hypertrophic scar. Burn patients with hypertrophic     scar are randomly assigned to either an intervention IFN group or a placebo control group by     subcutaneous injection three times a week. Patients are assessed using cutometer, mexameter,     standardized photography, urinalysis, blood work, tissue biopsies and the Vancouver Burn Scar     Assessment (VBSA) which rates selected HTS based on color, vascularity, height, pliability,     itchiness and pain sensitivity. Once on treatment patients are assessed monthly for the six     month treatment period.   "
216648|NCT00686491|"     Eleven National Sports Teams are located in the Quebec Metropolitan Area. In these groups,     many athletes are aiming for Olympic medals in Beijing 2008 and Vancouver 2010 Olympic Games.     A consultation of the coaches of these National Teams revealed that although a large     proportion of these athletes present various cardio-respiratory symptoms, they do not have a     rapid access to a systematic medical evaluation and follow-up. Furthermore, little is done in     regard to prevention and optimization of treatment of pulmonary and cardiac conditions in the     elite athlete's population of the Quebec area.      Cardiorespiratory problems are therefore commonly found in high-level athletes. However,     these pathologies are not well characterized in athletes and the associated symptoms often     not well perceived. These problems can be serious and it is important to detect them before     they appear1 while setting up a systematic medical follow-up. Health professionals should     monitor health of the young athletes and help to reduce the risks associated with high level     exercise. The following project is an evaluation and follow-up program of high-level     athletes, aiming at gathering key-information on long-term effects of high-level training on     cardio-respiratory and metabolic parameters. Our aims will be        1. to establish a long-term program of systematic evaluation and follow-up of          cardiorespiratory health and performance of high elite athletes.        2. to evaluate the prevalence of respiratory, circulatory and metabolic problems among          high-level athletes        3. to evaluate the effects of treatments on cardiorespiratory conditions and exercise          performance in athletes who need asthma medication.   "
216649|NCT00686504|"     The study is carried out in order to determine the relationship between AZD2066 exposure and     mGluR5 receptor occupancy in the brain and to demonstrate that AZD2066 can displace     [11C]AZ12713580 from mGluR5 binding-sites in the Central Nervous System   "
216650|NCT00686517|"     The objective of this study is to evaluate the efficacy of three regimens of pegylated     interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in     participants with acute hepatitis C. After 12 weeks of observation from disease onset,     participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN     monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3)     a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the     treatment period, participants will enter a 12-month follow-up.   "
216651|NCT00686530|"     Examination of the fetal brain at autopsy is technically challenging because of marked     fragility of the brain tissue. Studies have found postmortem fetal MR to be particularly     useful in examining gross structural abnormalities in fetal brain and spine. We have recently     included postmortem MR as part of the radiological studies for fetal autopsy workup. Using     the same MR data, the development of normal layering of the brain, also called laminar     organization, can also be assessed. This laminar organization of the brain is often disturbed     in congenital malformations. Our aim is to study the disturbance in laminar organization of     the postmortem brain with MR, using structural MR and a type of MR sequence called diffusion     tensor imaging, which is well suited for assessing the organization of the developing brain.     The postmortem MR findings will be compared with gold standard of histopathology. This will     help us understand the abnormal development of gray and white matter in brain malformations.     Knowledge gained from studying the abnormal laminar organization in brain malformations will     serve as a reference for future studies of fetal brain malformations in-utero using MRI.   "
216652|NCT00686543|"     The purpose of this study is: to explore the potential for different dosing strategies of     posaconazole oral suspension (POS) to increase plasma levels and to profile the     pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal     function and at high risk for Invasive Fungal Infection.   "
216653|NCT00686556|"     RATIONALE: Giving chemotherapy and total marrow irradiation before a donor umbilical cord     blood or hematopoietic stem cell transplant helps stop the growth of cancer cells. It may     also stop the patient's immune system from rejecting the donor's stem cells. When the healthy     stem cells from a donor are infused into the patient they may help the patient's bone marrow     make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from     happening.      PURPOSE: This phase I trial is studying the side effects and best dose of total marrow     irradiation when given together with combination chemotherapy and umbilical cord blood     hematopoietic stem cell transplant in treating patients with acute leukemia, acute myeloid     leukemia or multiple myeloma that did not respond to previous therapy.   "
216658|NCT00686621|"     The purpose of this study is to provide posaconazole compassionate treatment to patients with     invasive fungal infections: 1) which are resistant to standard antifungal therapies; 2) for     which there are no effective therapies; 3) with a prior history of serious, severe, or     life-threatening toxicities while receiving standard antifungal therapies, or 4) with     pre-existing organ dysfunction which precludes the use of standard antifungal therapies.   "
216659|NCT00686634|"     This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in     comparison to thiazolidinediones as the third-line oral agent, in patients with type 2     diabetes mellitus.   "
216660|NCT00686647|"     The purpose of this study is to evaluate a new angioplasty catheter, AngioSculpt® for the     treatment of bifurcation lesions (blockages occurring at branch points) in coronary arteries.   "
216661|NCT00686660|"     This is a multi-center prospective follow-up study.        -  to choose the stable COPD patients in community        -  to compare different modes of exercise (cycling and walking)        -  to compare the effect of different exercises on the quality of life,exercise          endurance,dyspnea and depression   "
216662|NCT00686673|"     This study is a randomized controlled trial that will compare two arms: an experimental     intervention group that receives a decision aid consisting of an educational video and     targeted manual providing a protocol for the family members' disclosing terminal illness to     the patients and aimed at improving communication, satisfaction with decision making process,     and quality of life between patients and their family versus an attention control group that     receives a video and non-tailored manual on pain control.   "
216663|NCT00686686|"     Subjects with psoriasis will receive intravenous infliximab 5 mg/kg given over a 2-hour     period at Weeks 0, 2, and 6 (induction therapy) to evaluate the efficacy of infliximab at     Week 18. Subjects who achieved >=75% improvement in Psoriasis Pustulosa Palmoplantaris Area     and Severity Index (PPPASI) score at Week 8 AND had deterioration of PPPASI score of 50% from     Week 8 until Week 12 were to receive an additional infusion at Week 12.   "
216664|NCT00686699|"     This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce     drug-induced involuntary movements in participants with schizophrenia or schizoaffective     disorder. Participants were to be evaluated for two 14-day treatment periods with a 3-week     washout period between treatment periods. The primary outcome measure, Extrapyramidal Symptom     Rating Score (ESRS), was to be evaluated frequently during the treatment periods.   "
216665|NCT00686712|"     To compare the efficacy and safety of once-nightly insulin glargine versus a single morning     injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients     inadequately controlled on combination oral agents.   "
216666|NCT00686725|"     The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery     temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the     standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma     multiforme.   "
216667|NCT00686738|"     The purpose of this study is to develop indices predicting response to pre-operative     chemotherapy in osteosarcoma patients. Histologic response to pre-operative chemotherapy is     very important for the ultimate outcome of osteosarcoma patients. Conventional methods such     as CT or MRI evaluating tumor response to chemotherapy is not so efficient in tumors like     osteosarcoma. Instead, the investigators will test whether blood TGF-b1 levels, PET/CT     findings, MRS findings as well as the level of NF-kB expression in tumor tissues can predict     chemotherapy response in osteosarcoma.   "
216668|NCT00686751|"     The purpose of this study to examine whether vitamin D can reduce the activation of the     immune system during dialysis. When activated, the immune cells release certain substances,     called cytokines, which can be measured from small blood samples. We want to study to what     degree the immune system is activated during a regular dialysis treatment and whether the     time point of vitamin D administration, either right before the start or right at the end of     a dialysis treatment, has an impact on the activation of the immune system.   "
216669|NCT00686764|"     Background: The formation of neuromas, a fusiform swelling of a nerve or nerve ending, is a     well documented response to limb amputation. Likewise, Residual Limb Pain (RLP), pain felt     from the remaining portion of the amputated limb, is common among amputees. Neuromas are     found in more than 90% of lower extremity amputations, of which 30-50% are pain-generating     for the patient . And while surgical techniques reveal the commonly held belief that neuroma     formation is one of the causal drivers behind RLP, there has been no study to demonstrate     that the two events - namely the magnitude of neuroma formation and the magnitude of pain     experienced by amputees - are correlated. If this correlation, or lack thereof, were     elucidated with the use of ultrasonography, this would provide the preliminary data which     could lead to further studies in neuroma minimization and/or proliferation.      Objective: This study seeks to use ultrasonography (US) to quantify the degree to which     neuroma size and the nature of surrounding tissue correlate with the experience of RLP in     trans-femoral amputees.      Setting and Subjects: This study will enroll 30 trans-femoral amputees, male and female, who     are over the age of 18. The study will take place in the OHSU Orthopaedic Outpatient Clinic,     and OHSU Imaging Department.      Intervention: None. This is an observational clinical study in which we will characterize the     sciatic nerve/neuroma and surrounding tissue using ultrasound.      Measurements: We will use US to measure the cross sectional area of the neuroma at its widest     point and compare this to the cross section of the same neuron at the lesser trochanter.     Furthermore, we will describe the morphology of the neuroma. To quantify the subject's pain     experience we will utilize the Questionnaire for Persons with Transfemoral Amputation     (Q-TFA), Trinity Amputation & Prosthetic Experience Scale (TAPES), Visual Analog Scale (VAS),     and the Short Form 36 (SF-36).      Analysis: The statistical analysis will employ a Pearson correlation coefficient and linear     regression analysis.   "
216670|NCT00686777|"     The objective is to evaluate the efficacy and safety of the combination therapy with     subcutaneous (SC) Pegylated Interferon (PEG-IFN) alfa-2b 1.5 ug/kg/week plus low-dose     ribavirin administered for 48 weeks in participants with chronic hepatitis C virus (HCV) who     are infected with HCV genotype 1 high viral load, and weigh 50 kg or less.   "
216671|NCT00686790|"     The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5     mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected     with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic,     biochemical, and histological response will be evaluated.   "
216672|NCT00686803|"     The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of     subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension.     Including in this evaluation is the effect PL3994 has on blood pressure.   "
216673|NCT00686816|"     This is a six (6) month, single center, randomized, double-blind, parallel,     controlled-feeding weight-loss study comparing two dietary groups (triglyceride and olestra)     in pre-diabetic obese women.   "
216674|NCT00686829|"     The purpose of this study is to provide open-label vicriviroc to HIV treatment-experienced     subjects who successfully completed 48 weeks of treatment on ACTG protocol A5211 (or who     responded favorably to treatment but discontinued participation due to viral tropism shifts),     and subjects who screened for ACTG A5211 and met all inclusion and exclusion criteria, but     were unable to enroll due to protocol closure. Vicriviroc will be administered in combination     with an optimized background antiviral regimen, chosen by the investigator based on results     of genotype and phenotype testing, the subject's history of prior antiretroviral drug use,     and drug toxicity. OBT must include at least 3 antiviral drugs (not including vicriviroc), 1     of which is a ritonavir-boosted protease inhibitor.   "
216675|NCT00686842|"     RATIONALE: PTC299 may stop the growth of Kaposi sarcoma by blocking blood flow to the tumor.      PURPOSE: This phase I/II trial is studying the side effects and best dose of PTC299 and to     see how well it works in treating patients with HIV-related Kaposi sarcoma.   "
216676|NCT00686855|"     The purpose of this research study is to determine the effectiveness of topical steroid     therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment     of oral chronic Graft-Versus-Host Disease (cGVHD)   "
216677|NCT00686868|"     This study will examine the safety and tolerability, PK and PD of subcutaneously administered     GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose     escalation/de-escalation phase to investigate the minimal efficacious dose based on PD     markers with an acceptable safety profile.   "
216678|NCT00686881|"     The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b)     monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in     participants with chronic hepatitis C (CHC) and liver fibrosis (Metavir fibrosis score of F2     and F3) who were previously treated with interferon. The trial will evaluate the effect of     treatment on the progression of liver fibrosis, liver inflammation, and liver function.     Treatment will be administered for up to 156 weeks with a 4-week follow-up.   "
216679|NCT00686894|"     Subjects will be given 3 infusions of infliximab according to the label at week 0, 2, and 6.     Subjects will be followed for a maximum of 18 weeks or until relapse. This study will assess     the ability of the Power Doppler Ultrasonography (PDUS) to be a reliable marker of enthesitis     response and relapse in subjects treated with infliximab.   "
216680|NCT00686907|"     The primary two foci of this five-year study will be to assess inter-individual variability     in the timing of the body clock of blind individuals, and to optimize the melatonin dosing     regimen for synchronizing body clocks of blind individuals to the 24-hour day.   "
216681|NCT00686920|"     This study will look at the safety of a drug used in patients who have had hepatic     encephalopathy in the past.   "
216682|NCT00686933|"     The objective of this study is to evaluate the long-term effects and tolerability of ABT-089     in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).   "
216683|NCT00686946|"     The National Register of Antipsychotic Medication in Pregnancy (NRAMP)is an observational,     nationwide study involving women of child-bearing age who take antipsychotic medication     during pregnancy. It follows the pathway of mother and baby during pregnancy and for the     first 12 months of the baby's life, in order to develop evidence-based guidelines for the     best use and effect of antipsychotic medication during pregnancy, thereby informing clinical     treating teams with regard to the management of their patients in this vulnerable population     group.      The investigators hypothesize that the provision of such evidence-based guidelines will     improve the management and outcomes for mother and baby during pregnancy, birth and the     postnatal phase, providing a positive impact on maternal and child health and wellbeing for     present and future generations.   "
216684|NCT00686959|"     This study will compare the overall survival of participants with locally-advanced, Stage III     Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.   "
216686|NCT00686985|"     Phase II studies with docetaxel in first line - and second line treatment of SCLC     demonstrated that docetaxel is an active agent in these patient groups. Therefore docetaxel     seems suitable for evaluation in combination with other cytotoxic drugs active in this     disease. A phase II study in previously untreated patients with SCLC shows that the     combination docetaxel and cisplatin/carboplatin is an active and well tolerated regimen in     extensive SCLC.   "
216687|NCT00686998|"     This study is designed to assess the effects of AZD 2624 in patients with schizophrenia   "
216688|NCT00687011|"     The purpose of this study is to determine if a single intravenous (IV) dose of palonosetron     0.25 mg plus a single IV dose of dexamethasone 8 mg is effective to prevent nausea and     vomiting induced by moderately emetogenic chemotherapy in subjects with cancer.   "
216689|NCT00687024|"     Focal cortical dysplasia (FCD) is a common finding in epilepsy surgery in pediatric patients.     Children with intractable epilepsy would have extensive tests to identify the cause of     epilepsy; this includes MR brain, video EEG and magnetoencephalography (MEG). The white     matter next to FCD is frequently found to be abnormal on pathology. Diffusion tensor imaging     (DTI) can be used to study the abnormal white matter and the area that often extends beyond     the area that is visible.   "
216690|NCT00687037|"     To prove the safety, in normal conditions, of the odontological use formulation of the     product Cepacol Canela Power.   "
216691|NCT00687050|"     End-stage renal disease is often accompanied by malnutrition due to less appetite, metabolic     changes or both. Human immunodeficiency virus-infection may exacerbate the state of     malnutrition. In a pilot study, we recruit both HIV invected and non-infected patients on     hemodialysis. Non-HIV patients will be randomized to peroral supplemental nutrition or no     peroral supplemental nutrition. All HIV patients will receive peroral supplemental nutrition.     The nutritional state will be determined in magnet resonance tomography at the start and at     the end of the study (muscle diameter of triceps m.) and with laboratory parameters (plasma     albumin and others). The hypothesis is that supplemental peroral nutrition (a total 250 kcal     per day) will stop loss of muscle mass in end-stage renal disease patients (compared to their     counterparts without supplemental peroral nutrition) as well as in the high risk group of HIV     patients. This pilot study may lead to larger randomized clinical trials and, may affect     dietary recommendations.   "
217030|NCT00691899|"     The purpose of this study is to investigate the effects of MK0822 in prolonging the time to     first bone metastasis in men with castration-resistant prostate cancer.   "
216692|NCT00687063|"     The study is conducted in Asia. The aim of this observational study is to evaluate the weight     change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under     normal clinical practice conditions in India.   "
216693|NCT00687076|"     Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of     a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which     can result in reduced blood flow to the legs and feet, occasionally causing leg pain and     fatigue. Early identification of PAD and treatment with lifestyle changes or medications can     help to keep legs healthy and lower risk for heart attack and stroke, but endovascular or     surgical procedures may be necessary for people with severe PAD. Even after endovascular     intervention, PAD symptoms must be continually monitored to prevent the development and     progression of blockages in the arteries. The best approach for monitoring symptoms is still     undetermined. This study will compare the effectiveness of an intensive combination of lipid     modifying medications versus standard lipid modifying medications in treating people with     significant PAD who have had an endovascular intervention.   "
216694|NCT00687089|"     People who addicted to Heroin and other opiates suffer from a disease with approved genetic     basis. It causes to a behavioral response as searching and using those drugs even though they     know it causes severe damages as physiological, familiar and legal affairs.      The popular treatment's goal is to clean the people from any drug. In a medical and     pharmacological point of view there is no sense in this approach for all people. This point     of view believes that Buprenorphine (Subutex) is a correct pharmacological treatment.      The hypothesis of this research is that people using Buprenorphine have difficulties in     gaining weight, in sexual and cognitive function (according to subjects' reports)   "
216695|NCT00687102|"     The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive     aging in selected cognitively-healthy women.   "
216696|NCT00687115|"     This study will investigate how to better predict why some individuals gain or lose weight     more easily than others. It will examine whether the increase in the amount of energy a body     burns in 24 hours with overeating or the decrease over 24 hours with fasting can help     determine how easily someone gains or loses weight.      Healthy people between 18 and 60 years of age who have a body mass index (BMI) between 18.5     kg/m(2) and 24 kg/m(2) (for overfeeding study) or a BMI greater than 27 kg/m(2) with a body     weight less than 350 pounds (weight loss study) may be eligible for this study. The study     requires a 10-week admission to the NIH Clinical Center (2-week baseline, 6-week     overfeeding/weight loss, 2-week post-weight change).      Participants undergo the following tests and procedures during the hospital admission:        -  Medical history, physical examination and laboratory studies        -  Questionnaires to assess eating behavior, food preferences, body composition, and          activity level        -  Body composition assessment (height, weight, waist circumference, and fat mass and          muscle content through DXA and MRI scans)        -  Oral glucose tolerance test        -  Meal test to measure the response of certain hormones to food        -  Activity monitors to determine activity level        -  Metabolic chamber study to measure calories burned over 24 hours and monitor body          temperature        -  Free-living energy use study to measure calories burned under normal home conditions          over 7 days        -  Fat and muscle biopsies        -  Dietary intervention: Measurements of food intake and energy loss over a 6-week          overfeeding (1.5 times the subject s normal food intake) or weight loss (one-half the          subject s normal food intake) program      Followup procedures after the inpatient stay:        -  Height and weight measurements at 6 months (overfeeding study participants) and monthly          for the first year, at 3-month intervals for the second year, and then yearly for 3 more          years (weight loss study participants)        -  Yearly visits (2-night inpatient stay) for all participants for repeat meal test, DXA,          oral glucose tolerance test, behavioral questionnaires and, in women who can become          pregnant, pregnancy test   "
216697|NCT00687128|"     This study investigates the degree of improvement in insulin resistance and features of the     metabolic syndrome in non-diabetic overweight or obese subjects after training in a     low-intensity, moderate-intensity or non-aerobic exercise program, as well as self-initiated     exercise behavior after the assigned exercise program.   "
216698|NCT00687141|"     The primary purpose of this study is to investigate the safety and tolerability of AZD0328     following once-daily dosing for 13 days in elderly healthy volunteers and to define maximum     tolerated dose.   "
216784|NCT00688285|"     To determine whether the use of educational sessions and computerized clinical reminders can     improve primary care doctors' delivery of care to CKD patients compared to educational     sessions alone. Hypothesis: Clinical reminders will improve the care delivered to CKD     patients   "
217734|NCT00695656|"     To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics,     health care management) of hypertensive patients seen in general practitioner consultation.   "
216699|NCT00687154|"     The development or worsening of macular edema following full scatter photocoagulation is a     well recognized occurrence. However, there is limited literature in this regard.      The purpose of this study is to determine the incidence and extent of macular edema following     scatter laser photocoagulation surgery using optical coherence tomography (OCT) in eyes     without macular edema prior to scatter laser photocoagulation and to explore whether the     incidence and extent of macular edema varies according to the number of sittings included in     the treatment regimen.      Study eyes will receive one of two types of scatter photocoagulation with results compared     through use of OCT and photography images, as well as visual acuity testing.   "
216700|NCT00687167|"     The purpose of this study is to evaluate the relative bioavailability (rate and extent of     absorption) of a test formulation of zonisamide capsules compared to the reference     formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under     non-fasting conditions.   "
216701|NCT00687180|"     A study with 20 de novo patients with autoimmune hepatitis, 10 receiving azathioprin and 10     receiving mycophenolat mofetil.   "
216702|NCT00687193|"     To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for     the treatment of signs and symptoms in patients with active RA who failed an adequate trial     of therapy with at least 1 DMARD in a 12-week therapy.   "
216731|NCT00687583|"     A breathing tube, which is used to secure the airway and allow ventilation of the lungs     during general anaesthesia, is inserted into the windpipe either through the nose or mouth.     In children, different formulas exist to determine the appropriate size of the tube according     to age, and how far it should be advanced into the airway. Head movement can alter the     position of the breathing tube, making it go in or come out too far. Different types of     breathing tubes may also differ in their change of position with head movement. The aim of     this study is to assess the accuracy of the formulae commonly used in our institution for     depth of breathing tube placement, and to measure the degree of tube displacement on head     movement with different types of tubes.   "
216760|NCT00687973|"     Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination     amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than     an atenolol/amlodipine combination based regimen.   "
216703|NCT00687206|"     Patients with slight increase in blood pressure levels have an increased cardiovascular risk.     In particular this has been demonstrated also in subjects with high-normal blood pressure in     whom an exaggerated blood pressure increase, during exercise, and structural left ventricular     abnormalities have been shown. On the other hand, the last American and European guidelines     for management of hypertension recommend more aggressive treatment in young-middle aged     subjects to achieve a better control of cardiovascular risk due to blood pressure increase.     In agreement with these recommendations the investigators share the idea that a good blood     pressure control should be achieved not only at rest, but also during psycho-physical stress     conditions that frequently occur during daily life. On this basis, the investigators decided     to evaluate the efficacy and tolerability of the association of valsartan and     hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood     pressure and first degree arterial hypertension with evidence of organ damage.      The aim of this study is to assess if an early and adequate therapy could bring to a better     pressure control (even during physical activity) and a regression of organ damage without     interfering with metabolism and erectile function   "
216704|NCT00687219|"     The objective is to evaluate the efficacy and safety of combination therapy with     peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks     in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants     who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment     will be discontinued from therapy.   "
216705|NCT00687232|"     The purpose is to investigate safety and tolerability of single and multiple ascending     inhaled doses of AZD4818 in healthy Japanese male volunteers.   "
216706|NCT00687245|"     The purpose of this study is to determine the area under the plasma concentration-time curve     (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg or 20 mg esomeprazole in     pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD.   "
216707|NCT00687258|"     The main purpose of this longitudinal study is to point out the effect of VitabranE on the     ESA resistance and on the anemia observed in HD patients undergoing EPO maintenance therapy.      As a secondary purpose we will consider the effect of VitabranE on inflammation and oxidative     stress parameters as a function of the changes observed in the anemia parameters.   "
216708|NCT00687271|"     The purpose of this study is to test the safety and effectiveness of MK6213 as compared to     MK6213/Atorvastatin in patients (18 to 75 years) with high cholesterol.   "
216709|NCT00687284|"     This study is conducted in Europe. An observational study evaluating glycaemic control in     patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in     Slovakia.   "
216710|NCT00687297|"     It has been shown in previous studies that the ability to treat lung cancer could be     significantly improved by not only targeting the tumor cells directly with chemotherapy, but     also by cutting off the blood supply to the cancer cells. Blood vessels that supply the tumor     are formed through a process called angiogenesis. Vandetanib is an investigational drug that     acts by producing what is called an anti-angiogenic effect. An Anti-angiogenic effect is able     to inhibit the development of new blood vessels required by tumors to survive by blocking the     growth factors needed to form new blood vessels.      The purpose of this study is to determine if the addition of vandetanib to a standard     chemotherapy regimen will slow or stop the growth of the cancer for a longer period of time     compared to the time period generally gained from the use of standard chemotherapy alone   "
216711|NCT00687310|"     The primary purpose of this study is to assess whether tailored patient education for     patients on Symbicort® Turbuhaler® therapy improves patient satisfaction, adherence and     Quality of Life.   "
216712|NCT00687323|"     The primary objective of this study is to evaluate the safety, tolerability, and efficacy of     temozolomide in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) participants     who are not candidates for standard induction therapy and exhibit low MGMT expression.   "
216713|NCT00687336|"     The goal of the study is to compare the effectiveness of empirical Helicobacter pylori     treatment compared with treatment depending on diagnostic tests for Helicobacter pylori in     patients with Upper gastrointestinal bleeding due to peptic ulcer. Main hypothesis is that     empirical treatment will reduce the number of patients lost to follow-up thus improving the     cure rates of Hp infection.   "
216714|NCT00687349|"     This research study is a randomized trial to evaluate a training program that is designed to     improve the communication skills of clinicians. The training program focuses on care for     patients with serious illnesses and their family members, and assesses effectiveness using     patient and family outcomes. The long term goal of this research is to improve communication     skills of doctors and nurses, thereby improving patient and family outcomes.   "
216715|NCT00687362|"     Middle Eastern subjects with moderate-to-severe chronic plaque psoriasis will be administered     infusions of infliximab (Remicade) at 5 mg/kg of body weight at Weeks 0, 2, 6, 14, and 22.     The safety and efficacy of infliximab monotherapy will be evaluated.   "
216732|NCT00687596|"     The purpose of this study is to determine whether TAC-101 as a second line therapy for     patients who received Sorafenib as first line therapy is effective in slowing tumor activity     in patients with advanced hepatocellular carcinoma. The study is also looking at the safety     of TAC-101 following treatment with Sorafenib.   "
216733|NCT00687609|"     The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD     (Attention Deficit/Hyperactivity Disorder) symptoms in adolescents with ADHD and comorbid     cannabis abuse.   "
216734|NCT00687622|"     MEK111054 is a first-time-in-human, open-label study to determine recommended dose and     regimen for the orally administered GSK1120212. The study consists of three parts. Part 1     will identify the maximum tolerated dose. Part 2 will explore the safety, tolerability, and     effectiveness of GSK1120212. Part 3 will determine a range of effective doses.   "
216761|NCT00687986|"     The standard treatment for an early stage I lung cancer is surgery. However, surgery can be     associated with complications and long-term impairment of the quality of life of patients.     Stereotactic radiotherapy (SRT) is a outpatient technique which allows for local control     rates that are comparable to those achieved using surgery. In this study, patients with stage     IA non-small cell lung cancer will be randomized to either surgery or SRT in order to study     the local and regional tumor control, quality of life and treatment costs at 2- and 5-years.   "
216716|NCT00687375|"     Laparoscopic inguinal hernia repair (LIHR) has got comparable results in comparison to open     hernia repair (OHR). Many studies have shown that LIHR gives similar results in terms of     recurrence as compared with OHR but with the added advantage of less chances of post     operative, pain, wound infection and early return to activity. LIHR was started using the     transabdominal preperitoneal (TAPP) approach. Another technique of LIHR that has evolved is     totally extra peritoneal (TEP) repair. There is only one study of 52 patients comparing TAPP     with TEP repair and thus there is insufficient information as to which of the 2 techniques is     better. Therefore, we have designed the present study to compare the transabdominal     preperitoneal (TAPP) technique with totally extra peritoneal (TEP) technique of laparoscopic     inguinal hernia repair. The advantages of TEP may include - no breach of peritoneum so less     risk of bowel injury and post-operative adhesions. We will be using a modified technique of     TEP repair where we will not use tacker to fix the mesh to reduce the cost of the procedure.     On the other hand, TAPP is easy to perform and probably better for irreducible hernia. There     is no such comparative study reported in the literature. We have been performing both TAPP     and TEP procedures for hernia repair regularly in the department.      RESEARCH HYPOTHESIS: TEP repair of inguinal hernia is better than TAPP repair in terms of     reduced cost and avoidance of peritoneal incision.      OBJECTIVE: To compare the Transabdominal preperitoneal (TAPP) vs. Totally extra peritoneal     (TEP) techniques of laparoscopic inguinal hernia repair.   "
216717|NCT00687388|"     Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms     from benign prostatic hyperplasia   "
216718|NCT00687401|"     Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic     therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions     (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The     efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).   "
216719|NCT00687414|"     Aim of the study is to analyze the expression of genes and sequences encoding the human     mammalian diaphanous (mDia) related formin proteins to test the hypothesis that defects in     the mDia expression or function might drive the pathophysiology of myelodysplastic syndrome,     acute myeloid leukemia and other myeloproliferative diseases.   "
216720|NCT00687427|"     The purpose of this study is to investigate the extent of return to work (RTW) after     traumatic hand injury and to identify factors that are related to RTW.   "
216721|NCT00687440|"     The purpose of this study is to evaluate, in a first stage, the safety (incidence of cardiac     toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the     tumor response rate of this regimen. This study will be conducted in approximately 30     centers. A total of approximately 70 to 95 subjects will be enrolled.   "
216722|NCT00687453|"     To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH     insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly     NPH insulin alone.   "
216723|NCT00687466|"     The purpose of this study is to evaluate whether the anticipated use of glargine in CF     patients with glucose intolerance may prevent the worsening of nutritional status and     pulmonary function.   "
216724|NCT00687479|"     The project objective is to validate a new indirect estimate of insulin status in both     pregnant African-American women and Caucasian women in southern Louisiana who are at risk for     gestational diabetes mellitus. There are racial differences in carbohydrate metabolism that     are potentially linked to complications during pregnancy and to increased risks of obesity     and diabetes in later life. The investigators will explore the use of indexes of insulin     status to identify the metabolic risk profile of pregnant women which may vary by race.     Understanding whether there are differences which vary by race may influence clinical     screening and treatment of pregnant women.   "
216725|NCT00687492|"     The survey will try to establish the proportion of patients on lipid-lowering pharmacological     treatment reaching the LDL-C goals according to the third NCEP ATP guidelines, overall and by     country.   "
216726|NCT00687505|"     The primary purpose of this study is to evaluate the safety and tolerability of FP-1039, a     new biologic treatment for cancer.   "
216727|NCT00687518|"     The aim of this study is to measure the variations of serum and urinary hepcidin levels     following a single intravenous injection of erythropoietin in healthy volunteers. Hepcidin is     a major regulator of iron homeostasis. It acts by binding on ferroportin, and limits cellular     efflux of iron through enterocytes and macrophages. Anemia and hypoxia are known to modulate     hepcidin synthesis. In these situations, erythropoietin synthesis is increased, so it can be     postulated that erythropoietin could modulate hepcidin synthesis.   "
216728|NCT00687531|"     Open label, 12-week clinical trial to assess efficacy, safety, treatment adherence and     Quality of Life impact of Mometasone Furoate dry powder 400 mcg once-daily in persistent     mild-moderate asthmatic patients at least 12 years old.      Protocol deviations may have occurred that resulted in quality issues associated with     reporting of the data.   "
216729|NCT00687544|"     In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected     with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin     (RBV) combination therapy. The efficacy rate (sustained virologic response, end of treatment     virologic response, and sustained biochemical response), the subject morbidity rate as caused     by other opportunistic infection (eg, bacterial pneumonia, tuberculosis, and other bacterial     infection), and the safety and tolerability of this combination therapy will be examined.   "
216730|NCT00687570|"     Traditionally bowel preparation before surgery of rectal cancer could be troublesome for     patients especially for patients with kidney and cardio- vascular diseases, where salt and     electrolyte balance can be a problem.      Cleaning the bowel without complications for the patient is one of the aims for this study.      The other aim is to see if patient nutritional status improves with nutritional drinks as a     complement to food intake 4-6 weeks before surgery.   "
216786|NCT00688311|"     The goal of this study is to test the hypothesis that daily ingestion of a 'synbiotic' for 4     weeks will improve intestinal function, ease immune system overactivation, and increase blood     CD4 count in HIV-infected individuals. A 'Synbiotic' is a mixture of probiotic bacteria and     dietary fiber.   "
217899|NCT00703703|"     This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine     on cardiovascular parameters in healthy subjects 50 years of age and older   "
216735|NCT00687648|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, and     prednisolone, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Estrogen can cause the growth of breast cancer     cells. Hormone therapy using anastrozole, letrozole, or exemestane may fight breast cancer by     lowering the amount of estrogen the body makes. It is not yet known whether giving     combination chemotherapy together with aromatase inhibitor therapy is more effective than     combination chemotherapy alone in treating breast cancer.      PURPOSE: This randomized phase II trial is studying giving cyclophosphamide, methotrexate,     and prednisolone together with aromatase inhibitor therapy to see how well it works compared     with cyclophosphamide, methotrexate, and prednisolone in treating postmenopausal women with     metastatic breast cancer.   "
216736|NCT00687661|"     Kidney disease is a fundamental part of medicine because of its prominence in Western     society. Common conditions such as diabetes, hypertension and kidney infections can all     progress to End-Stage Renal Disease (ESRD) also known as Stage 5 chronic kidney disease (CKD     5). Once ESRD has begun, kidney function is poor at best, thus the body is unable to     effectively clear harmful toxins from the blood.      A common feature of ESRD is vascular calcification, a process where blood vessels (especially     arteries) attract deposits of the mineral calcium. Over time, these deposits harden and     thicken in the layers of blood vessels, which limit blood flow to body tissues and can     produce significant disease including hypertension, heart disease and stroke. Although the     process of vascular calcification is unknown, there is mounting evidence that it is mediated     by cellular events that are similar to those seen in bone formation with in the body     (osteogenesis). With this point in mind, it has been suggested that agents medicine employs     to limit excess bone formation will reduce the rate of vascular calcification in CKD Stage 5.      This study will employ one group of drugs called bisphosphonates which have been used to     limit bone formation. It will study their effect on vascular calcification in adult dialysis     patients.   "
216737|NCT00687674|"     RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Lenalidomide may stimulate the immune system in different ways and     stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Sorafenib and lenalidomide may also stop the growth of cancer cells by     blocking blood flow to the cancer. Giving sorafenib together with lenalidomide and     dexamethasone may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib when     given together with lenalidomide and dexamethasone and to see how well they work in treating     patients with relapsed or refractory multiple myeloma.   "
216738|NCT00687687|"     To estimate the antitumor activity of paclitaxel, carboplatin, plus BSI-201 in patients with     recurrent or advanced uterine carcinosarcomas.      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
216739|NCT00687700|"     Study will investigate the pharmacodynamics of a dual pharmacophore in which a combination of     GSK961081 and Propanolol is used to give a total effect of bronchodilation.   "
216740|NCT00687713|"     This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects     with methamphetamine dependence who report using methamphetamine 29 or less days during the     30 days prior to the start of signing consent.   "
216741|NCT00687726|"     1. Simple home-based standing balance training and isometric knee extension exercise for 4          weeks would improve functional ability and knee muscle strength of patients with knee          osteoarthritis.        2. The outcome of standing balance training is different from isometric knee extension          exercise.   "
216742|NCT00687739|"     The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency     accelerates fat gain and abdominal fat accumulation in women.   "
216743|NCT00687752|"     310 singleton pregnancies (22-35 weeks) enrolled into the study. We assessed sonographically     the fetal larynx in an axial plane through the mandible and observed the fetal deglutition     movements .   "
216806|NCT00681824|"     The purpose of this study is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a     double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa     surgery as an adjunct to dura and dura substitute sutures in preventing postoperative     cerebrospinal fluid (CSF) leakage.   "
216744|NCT00687765|"     The phase I portion of study is designed to determine the Maximum Tolerated Dose (MTD) of     BSI-201 with two clinically relevant dosing regimens of temozolomide (TMZ). Secondary     objectives in the phase I trial include determining the PK of BSI-201 in malignant glioma     patients and correlating BSI-201 PK with degree of PARP-1 inhibition. A safety run-in will     confirm the safety of BSI-201 added to standard TMZ and radiation therapy and the phase II     portion of the study will assess the efficacy and tolerability of the MTD dose of BSI-201     with daily TMZ and radiation therapy followed by adjuvant TMZ in patients with newly     diagnosed GBM and assess overall survival as the primary outcome measure. Information on each     phase of the study will be listed when each phase opens for enrollment.      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
216757|NCT00687934|"     An open-label dose escalation study of patients with solid tumors treated with STA-9090     (ganetespib)   "
216758|NCT00687947|"     The aim of the present study is to explore the importance of migraine phenotype on the     headache/migraine responses after CGRP in FHM-patients, MA-patients and healthy volunteers.   "
216745|NCT00687778|"     F18-FDG is the widely used PET tracer in the routine practice of oncologic disease imaging     using the technology of PET-CT. However, FDG-avidity is a characteristic of the individual     tumor. There are various types of human malignancies, which are not taking FDG in access. In     these cases FDG is not a sensitive tracer of imaging. In search for other tumor PET tracers,     C11-Acetate has been shown recently in a few early studies to have a potential value in     imaging of non-FDG-avid tumors.      The purpose of the current study is to assess the role of 11C-acetate PET in various tumors,     which often are not detected by 18F-FDG and were not widely assessed until now.   "
216746|NCT00687791|"     The objective of this study is to determine the safety and effectiveness of the OculusGen™     (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy surgery. The primary     endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint     is to prove the safety via the incidence of complications and adverse events.   "
216747|NCT00687804|"     CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab     (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in     patients with visual impairment due to diabetic macular edema.      CRFB002D2301E1: A 24 month open-label extension study for participants who completed the 12     month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as     symptomatic treatment for visual impairment due to diabetic macular edema.   "
216748|NCT00687817|"     The primary objective of this study is to determine the overall response rate (complete     response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel     in patients with previously untreated locally advanced or metastatic non-small cell lung     cancer.   "
216749|NCT00687830|"     The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon     colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day     of the colonoscopy will be compared with that given on the morning of an afternoon     colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are     blinded to the randomization process.   "
216750|NCT00687843|"     Since it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric     cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using     TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.   "
216751|NCT00687856|"     Heart failure is a progressive disorder in which the weakened heart is not able to     efficiently pump blood throughout the body. When the body's cells do not receive enough     blood, this can result in fatigue, shortness of breath, and difficulty carrying out daily     activities. The left ventricular assist device (LVAD) is a device that is used to provide     mechanical circulatory support to patients with end-stage heart failure who are awaiting     heart transplants. Although LVAD support helps maintain the pumping ability of the heart and     dramatically improves heart failure symptoms, the quality of life with LVAD support is far     from ideal. It has been shown that LVAD support in selected patients may restore the failing     heart enough to eliminate the need for heart transplant, but more information is needed to     assess heart recovery and to guide weaning of LVAD support. Using data collected from     patients who have undergone LVAD implantation, this study will attempt to better assess heart     recovery and to generate criteria for identifying patients eligible for the removal of LVAD     support.   "
216752|NCT00687869|"     Primary objective of this study is to determine whether a case management of stroke patients     after discharge to home or to nursing home results in improving physical and cognitive     capacity one year after discharge.   "
216753|NCT00687882|"     The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to     evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3     months) anticoagulation in children with first-episode acute venous thrombosis. The first     stage of the trial has consisted of a pilot/feasibility component, which then continues as     the definitively-powered trial.   "
216754|NCT00687895|"     General objective: To improve the quality of fever case management in children in government     health facilities in Tanzania Hypothesis:The training of health workers, as well as     provision, training and use of microscopes for malaria diagnosis will improve the treatment     of clinical episodes of fever in children while reducing the amount and costs of drugs   "
216755|NCT00687908|"     The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide     2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously     treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline     Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.   "
216807|NCT00681837|"     The purpose of this study is to assess prevalence of gastrooesophageal reflux during     childhood and teenage years in France and to describe patients'symptoms and gastrooesophageal     reflux management   "
216808|NCT00681850|"     Demonstrate that the use of benchmarking improves quality of patient care, in particular the     control of diabetes, lipids and blood pressure, by determining the percentage of patients in     the benchmarking group achieving pre-set targets for HbA1c 14,18, LDL-cholesterol16,18 and     Systolic Blood Pressure17,18 versus control group (non-benchmarking group) after 12 months of     follow-up.   "
216756|NCT00687921|"     18F-fluoride is a positron-emitting bone-seeking agent with favorable pharmacokinetic     properties. Its uptake mechanism resembles that of 99mTc-MDP. After IV administration,     18F-fluoride diffuses through the bone capillaries into the bone extracellular fluid (ECF).     Its plasma clearance is more rapid than that of 99mTc-MDP and its single-passage extraction     efficiency is higher. The fast blood clearance of 18F-fluoride results in a better target-     to- background ratio. Bone uptake of 18F-fluoride is two-fold higher than that of 99mTc-MDP.     Combining the favorable pharmacokinetic characteristics of 18F-fluoride with the high     performance of PET technology, 18F-fluoride is a valuable imaging modality of the skeleton.      There are only few manuscripts on the role of static 18F-fluoride PET for detection of     lesions in patients referred for non-oncologic indications The purpose of the study is to     prospectively assess the added value of Fluoride PET/CT in the clinical setting of acute knee     injury. The findings of Fluoride PET/CT will be correlated with those found on arthroscopy     and MRI which the currently used diagnostic techniques with a high, however, not perfect     diagnostic accuracy regarding the issue of bone injury which is a critical component on the     long term outcome after knee injury.   "
216762|NCT00687999|"     The influence of insulin sensitivity and glucose tolerance on the effects of antiviral     therapy for HCV remains unclear. The aim of the present study was (1) To elucidate the     clinical and virological factors associated with sustained viral response in patients with     combination therapy with PEG-IFN and ribavirin. (2) To clarify the influence of diabetes     mellitus (DM), impaired glucose tolerance test (IGT) and insulin resistance (IR) on the HCV     response to combination therapy with PEG-IFN and ribavirin. (3) To test the influence of     combination therapy on HOMA IR   "
216763|NCT00688012|"     A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy     men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.   "
216764|NCT00688025|"     The present protocol will utilize simultaneous recording of brain activity during attention     and memory tasks in insomnia participants after ramelteon vs. zolpidem vs. placebo     administration. The investigators hypothesize that amplitudes of associated with memory will     be unchanged by ramelteon, whereas zolpidem will significantly reduce brain activity     associated with stimulus processing as evidenced by abnormal reduction in the amplitude of     specific brain regions relative to placebo.   "
216765|NCT00688038|"     The goal of this clinical research study is to learn how well magnetic resonance thermal     imaging (MRTI) can check the amount of tumor being destroyed using a therapy called laser     ablation (a procedure that uses lasers to create heat that is designed to destroy cancer     cells).   "
216766|NCT00688051|"     Nonadherence to treatment regimes among patients with cystic fibrosis (CF) is well documented     in the literature. Unfortunately, few interventions have been successful at improving     adherence rates in this patient population. Within the pediatric population, specifically     adolescents, attitude toward treatment directly effects adherence to treatment. Changing     attitude includes making conscious decisions regarding adherence or non-adherence and should     include an understanding of what outcomes will likely result from nonadherence.      This study will determine if attitudes can be enhanced and adherence to treatment regimen     improved in Cystic Fibrosis (CF) adolescent patients by using a simulation game My Life with     CF . The target population is CF patients ages 12-21 years. Attitudes will be assessed     utilizing four attitude scales in CF adolescents pre and post experiencing the simulation     game. In the simulation game, patients make life decisions, including CF therapy decisions,     using a fictional character diagnosed with CF. The game has been designed to help players     understand the long-term effects of health care choices. Data from this pilot study will     assess changes in attitudes and reported changes in adherence.   "
216767|NCT00688064|"     The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide     (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to     Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg     Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens     will also be evaluated.   "
216785|NCT00688298|"     The pre-pubic approach of the tension free vaginal sling placement is a new approach in the     treatment of SUI. The retropubic approach of the tension free vaginal sling is the standard     method of device delivery; in addition a suprapubic and a transobturator approach are     alternative methods of delivery. All of these delivery approach systems are intended to place     the mesh tension free in the mid-urethra.      There are currently no studies that investigate the pre-pubic delivery approach in the United     States. However, the largest series of cases in Europe using the pre-pubic system was done by     Ulmsten (published in the European Journal of Obstetrics and Gynecology and Reproductive     Biology) 107 (2003) 205-207, titled  Pre-Pubic tension free vaginal tape application: an     alternative to classic tension free vaginal tape application in selected patients with SUI.      The primary objective of this study is to evaluate the feasibility of using a pre-pubic     approach to the placement of a mid-urethral vaginal mesh.        -  Demonstrate the mesh can be properly placed in the mid-urethra using a pre-pubic          approach;        -  Assess the performance of the delivery device by measuring the ease of use, technical          complexity, and instrument difficulties   "
216768|NCT00688077|"     Introduction:      Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an     FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important     regulator of FGF-23 production and secretion in healthy humans.      Aim:      In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.      Study Design:      placebo-controlled, cross-over study      Method:        -  All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml          NaCl 0.9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously        -  On both occasions frequent bloodsampling will take place, out an indwelling catheter in          de forearm vein.        -  Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes        -  Mealtimes: Calcium and Phosphate intake standardized on both occasions        -  All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics,          San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that          measures only intact FGF-23        -  Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca,          albumin, PO4, PTH, 25-OHD and 1,25-OHD      Endpoint:      A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of     calcitonin 200 IU.   "
216769|NCT00688090|"     A dose comparison of a multi-component active immunotherapy designed to stimulate an immune     reaction to specific tumor associated antigens which are highly expressed on melanomas.   "
216770|NCT00688103|"     Multi-center, parallel-group, randomized, open control study. All patients will be selected     to two treatment groups.        1. Etanercept alone treatment group (25mg, twice/week, s.c.)        2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)   "
216771|NCT00688116|"     An open-label dose escalation study of patients with solid tumors treated with STA-9090     (ganetespib)   "
216772|NCT00688129|"     The KITS project is a 5-year randomized trial to evaluate a program designed to enhance     academic and social-emotional aspects of school readiness for foster preschoolers.   "
216773|NCT00688142|"     The investigators hypothesize that in patients with shift work sleep disorder, armodafinil     will specifically increase brain activity in the frontal cortex parallel with improvements in     deficits of fundamental mechanisms of attention.   "
216792|NCT00688389|"     The study will collect the blood samples from 350 healthy persons and 350 persons infected     with dengue fever.   "
216774|NCT00688155|"     The purpose of this pilot study is to develop and conduct well-designed trial to assess     whether a multi-factorial intervention involving physical activity and cognitive training     reduces the risk of significant cognitive decline in older individuals.   "
216775|NCT00688168|"     The goal of this research study is to learn about the pain and/or other symptoms that     patients may experience either while you are being monitored by your doctor before a decision     is made to start you on treatment for your MM, or during and after treatment for MM, and how     these symptoms may affect therapy. A second goal is to learn how differences in genes may     affect the symptom burden from cancer and cancer therapy.   "
216776|NCT00688181|"     Registry to gather information about the long term use of the Prefyx PPS System which     utilizes a pre-pubic surgical approach (device is to be placed in front of the pubic bone)     for the treatment of SUI. No additional procedures are required beyond the physician's     standard of care.   "
216777|NCT00688194|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     fulvestrant and exemestane, anastrozole, or letrozole may fight breast cancer by blocking the     use of estrogen by the tumor cells and by lowering the amount of estrogen the body makes.     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. It is not yet known whether fulvestrant is more effective with or without lapatinib     and/or aromatase inhibitor therapy in treating breast cancer.      PURPOSE: This randomized phase III trial is studying fulvestrant with or without lapatinib     and/or aromatase inhibitor therapy to compare how well they work in treating postmenopausal     women with metastatic breast cancer that progressed after previous aromatase inhibitor     therapy.   "
216778|NCT00688207|"     The present pharmacokinetic study is designed to assess the pharmacokinetics of RSG XR as     monotherapy in patients with mild Alzheimer's disease (AD) as such information will not be     obtained from the current phase III trials . The study aims to enroll fourteen patients     (seven of each APOE genotype). Each patient will receive a single oral dose of 4mg of RSG XR     in the morning under fasted conditions and PK samples will be taken up to 36h.   "
216779|NCT00688220|"     The purpose of this research is to determine whether a new type of fabric, Celliant, can     reduce elbow and wrist pain associated with chronic medical conditions such as carpel tunnel     syndrome, arthritis or tennis elbow and whether it can increase blood flow and oxygenation     levels in the arms and hands after wearing the material.   "
216780|NCT00688233|"     For improving the appearance of protruded upper front teeth when lower front teeth may touch     palatal mucosa or have proximity to that; the innovated Seifi's Functional Appliance may be     used.   "
216781|NCT00688246|"     RATIONALE: Learning about the effect of exemestane on bone mineral density in postmenopausal     women at increased risk of breast cancer may help plan treatment, decrease the risk of broken     bones, and help patients live more comfortably.      PURPOSE: This research study is measuring bone mineral density in postmenopausal women at     increased risk of developing breast cancer who are receiving exemestane on clinical trial     CAN-NCIC-MAP3.   "
216782|NCT00688259|"     This is a study comparing the benefits of two types of individual psychotherapy     (cognitive-behavioral therapy for psychosis and supportive therapy) in outpatients with     schizophrenia or schizoaffective disorder. Treatment lasts 6 months and there are multiple     assessment points.   "
216783|NCT00688272|"     This study is designed to investigate the safety profile and the photoirritant potential of     eltrombopag in healthy subjects. The study is placebo- and positive controlled, randomized,     parallel group with three treatment arms: eltrombopag (75 mg QD), placebo, and a positive     control (ciprofloxacin, 500 mg BID). Eltrombopag will be administered in a double-blind     fashion with respect to placebo and the positive control, ciprofloxacin, will be administered     under observer-blinded conditions. Twelve to fifteen subjects will be recruited into each     arm, to assure total enrollment of 36 evaluable subjects. The primary endpoint is the     photosensitizing potential of eltrombopag as measured by photoirritant index (PI) and change     in minimum erythemal dose (MED) in comparison with placebo.   "
217900|NCT00703716|"     The purpose of this study is to evaluate the stabilization of trochanteric fracture using a     screw-plate TRAUMAX   "
216787|NCT00688324|"     NMDA receptors are brain receptors that are stimulated by glutamate. Poorly functioning NMDA     receptors are thought to be involved in the pathology of schizophrenia. This hypothesis is     based on the observation that PCP, which blocks the NMDA receptor, produces symptoms and     cognitive impairments similar to schizophrenia. Efforts to enhance the function of the NMDA     receptor with glycine and D-cycloserine have met with limited success. An alternative     approach would be to use the drug acamprosate.      Acamprosate, FDA-approved for maintenance of sobriety after detoxification from alcohol,     seems to act through modulation of the NMDA receptor. In the lab, acamprosate has been noted     to act as an antagonist when the NMDA receptors are maximally stimulated but as an agonist     when NMDA receptor stimulation is minimal. This smart drug action makes acamprosate     appealing for use in schizophrenia. If acamprosate works as a smart drug in patients, then we     would predict that it would enhance the function of NMDA receptors in schizophrenia and     improve cognition and the symptoms of the illness. Additionally, acamprosate seems to     modulate the NMDA receptor in novel ways distinct from glycine and D-cycloserine.      We will also see if the response to acamprosate differs based on whether participants do or     do not have a past history of alcohol use disorders.   "
216788|NCT00688337|"     In the current study FDG (Fluorodeoxyglucose) uptake, FLT uptake     (F18-Fluoro-3'-deoxythymidine) and their ratios will be correlated with the risk score     results of the Oncotype gene-expression assay in patients with clinically negative nodal     disease planned for surgical removal of the tumor.   "
216789|NCT00688350|"     The purpose of this study is to test an intervention to help older adults do a better job of     following blood pressure medication regimens prescribed by their health care providers.   "
216790|NCT00688363|"     The purpose of this randomized, prospective trial is to determine wether (a) a once weekly     glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated     haemoglobin are effective interventions to improve HbA1c after one year in typ 2-diabetic     patients on conventional insulin treatment.   "
216791|NCT00688376|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil     in children with persistent attention impairment that is present at least 12 months after the     completion of cancer treatment.   "
216794|NCT00688415|"     This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may     stimulate the immune system to help fight cancer. The purpose of the study is to assess the     safety of the investigational drug and to identify the highest dose that is well-tolerated.     The pharmacology of VTX-2337 will also be evaluated.   "
216795|NCT00688428|"     The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is     pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet   "
216796|NCT00688441|"     The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the     treatment of Seasonal Allergic Rhinitis   "
216797|NCT00688454|"     The study explores efficacy and safety of the lipid-lowering therapy with CRESTOR in     statin-naive patients and in patients with previously unsuccessful statin therapy. This study     was designed to investigate the dynamic of the lipid parameters and therapy tolerability     during 8-10 weeks treatment with CRESTOR   "
216798|NCT00688467|"     Evaluation of treatment in participants with mild asthma.   "
216799|NCT00688480|"     Cardiovascular related disease is the main cause of death in patients with kidney disease,     and oxidative stress is thought to be a major contributor by promoting thickening of the     heart muscle and stiffening of the arteries. Allopurinol, a drug used safely in the treatment     of gout for many years, has been found to dramatically reduce oxidative stress. It is     therefore hoped that it also reduce the thickened heart muscle and stiffened arteries. If it     did, it is likely to reduce the appallingly high cardiac death rate in this group of kidney     disease patients.   "
216800|NCT00688493|"     The main purpose of this study is to examine the effect of dapagliflozin on electronic     measures of heart beats in healthy males   "
216801|NCT00681759|"     The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in     patients with cardiovascular disease taking low dose aspirin   "
216802|NCT00681772|"     Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection     sufficient for satisfactory sexual performance. An ideal treatment option should be effective     and reliable, have minimal side effects, be simple to use and affordable. The aim of this     study was to investigate safety, tolerability and efficacy of vardenafil following a flexible     dose treatment schedule in subjects with varying aetiology.   "
216803|NCT00681785|"     The rationale for thrombophrophylaxis is well known. Without prophylaxis the incidence of     objectivlely confirmed, hospital-acquired deep venous thrombosis is approximately 10% to 40%     among medical or general surgical patients. In urology the prevalence is 15-40%. The Seventh     ACCP Conference on Antithrombotic and Thrombolytic Therapy1 recommend against specific     prophylaxis in patients undergoing transurethral procedures. Our study is the first     double-blind, placebo-controlled study with Dalteparine as thrombophrophylaxis in     transurethral surgery. The aim of the study is to proof that thrombophrophylaxis causes not     more complications in transurethral surgery than without.   "
216804|NCT00681798|"     The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended     dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine   "
216805|NCT00681811|"     This is a multi-center, open-label, extension study of patients with late infantile MLD who     have previously completed clinical study HGT-MLD-048 (NCT00633139), defined as the completion     of all Week 52 procedures. This group of patients will be offered ongoing treatment with     HGT-1111 in this protocol. One infusion will be given every other week until the product is     commercially available, the patient discontinues, or the study is terminated by the Sponsor,     provided no safety issues have emerged.   "
217247|NCT00697840|"     The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity     of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when     administered at 0, 6 months   "
216809|NCT00681863|"     The primary objective of this open-label, flexible dose study is to assess the safety and     efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years     inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of     Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641     (NCT 00681863) or 248.644 (NCT 00558467).   "
216810|NCT00681876|"     This phase II study will evaluate the efficacy of the combination of two monoclonal     antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed     after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.   "
216811|NCT00681889|"     The purpose of this study is to determine the effectiveness and safety of ranibizumab     (Lucentis) in treatment of corneal neovascularization.   "
216812|NCT00681902|"     The purpose of this study is to explore to what degree, if any, Jet lidocaine will reduce or     alleviate pain, as compared to Jet normal saline, in children undergoing needle insertion in     the Pediatric Emergency Department (PED). If effective, Jet lidocaine would afford a novel     rapidly acting local anesthesic for children in the PED.   "
216813|NCT00681915|"     This is a study to evaluate safety, tolerability, PK and PD effects of orally administered     AZD7325 after single and repeated ascending doses.   "
216814|NCT00681928|"     RATIONALE: Gathering information about cognitive function over time in postmenopausal women     with breast cancer may help doctors learn about the long-term effects of aromatase inhibitor     therapy and plan the best treatment.      PURPOSE: This clinical trial is studying cognitive function in older postmenopausal women     with stage I, stage II, or stage III breast cancer receiving hormone therapy and in healthy     volunteers.   "
216815|NCT00681941|"     Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this     study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this     study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an     effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD     patients not on dialysis. Total length of participation is approximately 14 weeks.   "
216816|NCT00681954|"     The purpose of the study is to determine whether transfusion is associated with mild     pulmonary changes.   "
216817|NCT00681967|"     To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation     radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and     Iressa   "
216818|NCT00681980|"     Is the valproic acid efficacy to treat TSP/HAM   "
216819|NCT00681993|"     Breast conserving therapy, (BCT), which consists of wide local excision of the tumor followed     by 6 weeks of whole breast irradiation, (WBI), is integral to the management of breast     cancer. Evidence now suggests that WBI may not be necessary and treatment to the involved     area only, partial breast irradiation, (PBI), may suffice. PBI can be achieved by     interstitial or intracavitary brachytherapy, intra-op, or post op external beam radiation     therapy. The feasibility, toxicity and efficacy of PBI are currently being studied in both     the U.S. and Europe. Review of smaller studies suggests that PBI will prove to be comparable     to WBI. Chemotherapy combined with radiation has been shown to increase local control in BCT     when compared to radiation alone. However there is little data on how sequencing or timing of     these therapies with respect to one another affect outcome. As a result there is no consensus     about the optimal combination. There are real and potential benefits to concurrent     chemo-radiation therapy. Concurrent therapy 1) allows both treatments to start closer to     surgery, theoretically maximizing the benefits of each modality; 2) shortens the overall     treatment program; and 3) may also improve local control via chemo-sensitization of residual     cancer cells. However, concurrent chemotherapy and WBI have been associated with prohibitive     skin toxicity. Since less breast tissue is treated with PBI, this skin toxicity may no longer     be prohibitive. We have shown in J0381 that PBI and concurrent dose dense AC is safe. As a     follow-up, we propose a phase I/II trial addressing the toxicity and efficacy associated with     PBI delivered concurrently with various chemotherapy regimens.   "
216820|NCT00682006|"     The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and     meticulous hand washing by primary health care providers of newborn infants will reduce the     incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord     care.   "
216821|NCT00682019|"     The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil     therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile     dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual     intercourse. In addition it should have been determined, if subjects with ED from a broad     etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours     prior to sexual intercourse.   "
216822|NCT00682032|"     The purpose of this study is to determine how beta-glucan affects the immune system in     subjects with non-small cell lung cancer.   "
216823|NCT00682045|"     The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. T-SPOT.TB     assay) for diagnosis of latent tuberculosis infection (LTBI) in renal transplant recipients.     For this purpose, the investigators enrolled renal transplant recipients and observed the     developement of tuberculosis within 1 to 2 years after the transplantation.   "
216824|NCT00682058|"     The aim of this study is to measure important components of weight change in patients who     underwent bariatric surgery on measures of fat mass and its distribution and fat-free mass     (FFM) (bone mineral density, skeletal muscle, and specific organs) at 60 months (T60) and 84     months (T84) post-surgery, and to compare compartment sizes with stable weight controls.   "
216825|NCT00682071|"     Ultrasound (US) guided embryo transfer (ET) appears to improve pregnancy outcomes in IVF-ET.     Most reports are done using a transabdominal (TAS) approach, in contrast to a transvaginal     ultrasound (TVS) which does not require a full bladder. We sought to determine if either     approach was better with respect to clinical outcomes.   "
216826|NCT00688506|"     Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians     once conventional therapies fail.      We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in     men. In addition, we postulate that combined sono-electro-magnetic therapy as well as placebo     therapy has a significant effect on brain activity detectable by functional MRI.   "
216827|NCT00688519|"     The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with     plaque-type psoriasis.   "
216828|NCT00688532|"     A retrospective cohort study performed in the GPRD,UK. All patients with incident prostate     cancer identified between 1 Jan 1999 and 31 Dec 2005 and a frequency-matched cohort of the     general population will be followed- up for two outcomes; CHD including acute myocardial     infarction or death from coronary heart disease and HF until Dec 31, 2006. Outcomes will be     validated through requests to primary care physicians. Incidence rate´ratios of CHD and HF in     the two cohorts will be calculated. In the cohort of prostate cancer the relative risk of CHD     and HF associated with the use of bicalutamide compared to non-use will be estimated.   "
216829|NCT00688545|"     This multi-center observational Registry will collect long-term safety data on patients     treated with celecoxib or non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) as     used in clinical practice for the treatment of Juvenile Idiopathic Arthritis (JIA).   "
216830|NCT00688558|"     The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of     JTT-705 compared with placebo when co-administered with simvastatin 40 mg in patients with     low HDL   "
216831|NCT00688571|"     This non-randomized, prospective, interventional observational multi-center study is designed     to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary     Valve (TPV) in the post market environment over a period of five years after transcatheter     implantation in patients with dysfunctional RVOT conduits. In addition, the quality of life     of implanted subjects will be assessed over five years.   "
216832|NCT00688584|"     The major objective of this proposal is to conduct a randomized controlled trial of an     ultra-brief, personalized feedback intervention (a pamphlet) for problem drinkers. Subjects     will be recruited via a telephone survey which will collect baseline data. The households of     half of the subjects will receive the pamphlet as unaddressed ad mail shortly thereafter.     Follow-up interviews will be conducted, by telephone, three and six months after the mailing     of the pamphlets.      Hypothesis 1: Respondents from households who receive the pamphlet will display significantly     improved drinking outcomes at the three-month and six-month follow-ups as compared to     respondents from households in the no intervention control condition.      Hypothesis 2: More calls will be received on a help-line listed on the pamphlet (and     advertised elsewhere) from residents of households who receive the pamphlet as compared to     residents from households who do not receive the pamphlet.      Hypotheses 3 - 6 deal with mediator and moderator hypotheses, exploring the role of perceived     risk, perceived drinking norms, and drinking for social reasons.   "
216833|NCT00688597|"     The main purpose of this study is to determine the safety and tolerability of three different     doses of AT2220 in people affected by Pompe disease. The study will also evaluate the effects     of AT2220 on functional parameters in Pompe disease.   "
216834|NCT00688610|"     Antibiotics in patients with acute respiratory tract infections in primary care in     consideration of procalcitonin as additive parameter.      The purpose of this study is to compare the ordinary manner of antibiotic- prescription with     the prescription in consideration of procalcitonin-value in patients with acute respiratory     tract infections.   "
216835|NCT00688623|"     To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line     treatment of patients with metastatic papillary carcinoma of the kidney.   "
216836|NCT00688636|"     A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's     disease 12 months after curative, resective ileal or ileocolonic surgery in patients     receiving post-operative infliximab or placebo   "
216837|NCT00688649|"     Disease-related malnutrition is common across healthcare settings in the UK and if left     untreated, may have severe consequences. One of the strategies commonly used to combat     malnutrition is the use of oral nutritional supplements (ONS). However, there is uncertainty     about the optimal way of delivering ONS to patients to maximize compliance and nutrient     intake.      This randomised study will investigate the effect of different modes of delivery (ad libitum     versus instructions on timing/serving volume) of ONS used in addition to the diet on total     nutrient intake, compliance, nutritional status and outcome in participants at risk of     malnutrition.      Participants will be randomised to receive one of two ONS (high energy or standard) for 4     weeks in addition to food, either taken 'Ad libitum', or according to instruction on what to     take and when. The primary outcome measure is nutrient intake. Secondary outcome measures     include compliance and acceptability of ONS, appetite, anthropometry, muscle strength,     quality of life and gastro-intestinal tolerance.   "
216838|NCT00688662|"     The Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction(SOD) study     (EPISOD) is a randomized sham-controlled study of biliary and pancreatic sphincterotomy as     treatment for patients with pain after cholecystectomy fitting the criteria for sphincter of     Oddi dysfunction type III.   "
216839|NCT00688675|"     Document how Swiss GPs allocate their GERD patients to the three GERD patient segments     (according to King et al.) and how treated GERD patients are affected by their GERD treatment   "
216840|NCT00688688|"     The study is intended to test the safety, tolerability, efficacy of two doses of long term     once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and     secondly to compare these with active comparator.   "
216841|NCT00688701|"     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in     comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period     of 12 weeks of treatment.      The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on     glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin     (HbA1c) reduction (absolute change) at Week 12.      Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on     glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration     regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour     postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and     tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.   "
216842|NCT00688714|"     AZD6482 is a new drug substance aiming to prevent blood clots which may arise in     atherosclerotic blood vessels and cause myocardial infarction or stroke. This is the first     study with AZD6482 in humans. The primary aim for this study is to evaluate the safety and     tolerability of AZD6482 in healthy human volunteers. How the substance is metabolised and     eliminated from the body will also be studied. This will be done by comparing the effect of     single ascending doses of AZD6482 to placebo (inactive substance).   "
216843|NCT00688727|"     The purpose of this study is to determine whether adults with disoociative (psychogenic     non-epileptic) seizures receiving cognitive behavioural therapy (CBT) show a greater     reduction in seizures and health service use and greater improvement in employment status and     overall psychosocial functioning than patients who receive standard care.   "
216844|NCT00688740|"     The purpose of this study was to compare disease-free survival after treatment with docetaxel     in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with     doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary     lymph nodes.   "
216845|NCT00688753|"     To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line     treatment of patients with metastatic papillary carcinoma of the kidney.   "
216846|NCT00688766|"     IPI-504-06 is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to     evaluate the efficacy and safety of IPI-504 as compared to placebo in patients with     metastatic and/or unresectable GIST following failure of at least imatinib and sunitinib.      Approximately 195 patients will be randomized using a 2:1 ratio to receive either IPI-504     (N=130) or placebo (N=65). Upon unblinding, patients receiving either IPI-504 or placebo may     receive IPI-504 in the open-label portion of the study if defined inclusion criteria are met.      Early and frequent imaging timepoints (Weeks 2, 5, 8, 14 and every 6 weeks thereafter) are     incorporated into this study to capture progression events and limit patient exposure to     ineffective agents.   "
216847|NCT00688779|"     Investigate safety/tolerability after a single dose intranasal administration of AZD8848     comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients     out of season   "
216848|NCT00688792|"     A questionnaire will be used in order to find out the reasons for poor adherence for     long-term treatment in children with asthma. The hypotheses is maternal factors including the     knowledge that asthma is a chronic disease and fear to administer inhaled steroids are major     obstacles for appropriate adherence.   "
216884|NCT00689975|"     RATIONALE: Studying diet and exercise interventions in overweight and obese patients with     breast cancer may help doctors learn more about how to help patients lose weight and change     their body composition.      PURPOSE: This randomized clinical trial is studying diet and exercise to see how well it     works compared with normal care in overweight or obese women who have undergone treatment for     stage I, stage II, or stage III breast cancer.   "
216849|NCT00688805|"     Background:        -  Relapse to drug abuse is thought to result, in many cases, from exposure to cues that          trigger drug-related memories or emotional associations for example, the association          between the sight of a crack pipe and a set of responses such as rapid heartbeat and          desire for cocaine. This type of memory is reconsolidated (actively re-stored) each time          it is reactivated; however, the reconsolidation process can be disrupted by the drug          propranolol, which weakens the link between that memory and an emotional response.        -  Propranolol is traditionally used to treat high blood pressure and other heart-related          conditions. Researchers are interested in studying whether propranolol disrupts          reconsolidation of drug-cued memories in individuals who are addicted to cocaine.      Objectives:      - To examine whether propranolol can interfere with reconsolidation of cocaine-related     memories and reduce cravings and drug use in substance abusers.      Eligibility:      - Individuals between 18 and 55 years of age who are current cocaine users enrolled in a     methadone treatment program.      Design:        -  The study will involve four long sessions (visits 1, 4, 6, and 14) and 10 short          sessions. The short visits will be for monitoring of participants use of drugs and          alcohol; the longer visits will involve more tests and lab sessions. Participants will          be randomized to either the propranolol or placebo group.        -  The long sessions will involve the following procedures:        -  An interview session to develop a personalized drug script/cue set.        -  A two-hour intervention session with baseline measures, drug administration (propranolol          or placebo), and two script-guided imagery sets. This is the only administration of          propranolol during the study.        -  Two follow-up test sessions, 1 and 5 weeks after the intervention session.        -  Participants will make brief visits to our outpatient clinic for twice-weekly monitoring          of ongoing drug use via urine screens and self-report, starting 1 week before the          intervention session and ending 5 weeks later.   "
216850|NCT00688818|"     This multi-centred study will be conducted at three centres. The design will be a randomized,     placebo-controlled, parallel-group one. This investigation will evaluate the efficacy of     add-on Quetiapine XR (extended release) treatment for patients who meet diagnostic criteria     for depressive disorders and one or more comorbid anxiety disorder.   "
216851|NCT00688831|"     The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the     medication is metabolised by the body (how it is taken up into the body, distributed around     the body and disappears from the body   "
216852|NCT00689559|"     The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or     not, i.e. show the same or altered plasma concentration profiles when co-administered     compared to administered alone.   "
216853|NCT00689572|"     This study will evaluate the efficacy of ondansetron compared with placebo in the treatment     of cocaine dependence.   "
216854|NCT00689585|"     Pain remains the most debilitating symptom for adult patients suffering from complex regional     pain syndrome (CRPS). Most CRPS patients gain little to no relief from current painkillers.     The purpose of this study is to evaluate the efficacy and safety of ethosuximide in search of     much-needed adjunctive therapy to relieve the pain and suffering associated with CRPS.   "
216855|NCT00689598|"     To determine whether or not spironolactone can prevent or delay the occurrence of atrial     fibrillation.   "
216856|NCT00689611|"     Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent     event or death compared with those who quit. Many patients attempt to stop smoking after a     heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been     shown to be effective for the general population. However, bupropion is the only non-nicotine     replacement therapy shown to improve abstinence rates in healthy young smokers. Furthermore,     nicotine replacement therapies (NRTs) are contraindicated in the immediate period following a     heart attack because of the undesirable effects of nicotine. Although bupropion has been     successfully used to reduce smoking rates in healthy young populations, its efficacy and     safety in the setting of patients recovering from an ACS is unknown. These patients, if they     continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion     is effective in this population, it will have a major impact on secondary prevention of     recurrent clinical events in patients who suffer a heart attack.   "
216857|NCT00689624|"     This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young     patients with good performance status with unresectable metastatic colorectal cancer.   "
216858|NCT00689637|"     The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or     not, i.e. show the same or altered plasma concentration profiles when co-administered     compared to administered alone.   "
216859|NCT00689650|"     The objective was to evaluate the efficacy of 1540 nm fractional laser treatment of mature     burn scars.   "
216860|NCT00689663|"     Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as     a fundus first dissection.      Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way     of dissection has to be established. Patients are at 4 hospitals randomised to the different     techniques and the different methods of dissection.   "
216861|NCT00689676|"     The aim of the present study is to describe the performance of very low birth-weight preterm     toddlers regarding expressive language and cognitive development during sensorimotor and     beginning of pre-operational periods, as well as to compare the performance presented by     these children to that presented by their full-term peers, according to Genetic Epistemology     theoretical principles.      The hypothesis of this study is that very-low birth weight preterms would present a poorer     performance, concerning expressive language and cognition development,than their full-term     peers.   "
216862|NCT00689689|"     The purpose of this study is to answer the question as to whether or not a fully coated     cementless stem is equal to or better than a cemented stem in patients over 72 years with     good bone quality.   "
216863|NCT00689702|"     This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added     to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced     primary resectable rectal cancers.   "
216885|NCT00689988|"     Children with Down syndrome (DS) have language development particularities that have negative     effects in the communication capacity. By this way, Augmentative and Alternative     Communication (AAC) is indicated to this population. The aim of this study was to verify the     AAC impact in the lexical gain of children with DS.   "
216886|NCT00690001|"     To assess the HIV resistance rate to variable antiretroviral agents in Taiwan, especially in     patients with treatment failure, and to know the correlation between the drug resistance     pattern and the HIV subtype, we will enroll a total of 150~200 HIV-1-infected subjects to     perform genotypic resistance testing and try to establish facility of phenotypic resistance     testing.   "
216913|NCT00690352|"     This social science study hypothesizes that convicted felony drug offenders in Nebraska who     participated in Specialized Substance Abuse Supervision (SSAS) as part of their probation or     parole showed significantly better outcomes (specifically, less recidivism) at six months     post-entrance to SSAS compared to those who did not participate in SSAS.   "
216864|NCT00689715|"     Cystic lesions of the pancreas are defined as round, fluid-filled structures within the     pancreas detected by radiologic imaging. With widespread use of cross-sectional imaging     modalities for various indications, such lesions are now detected in nearly 20% of abdominal     imagings, with the majority discovered incidentally. These lesions encompass a wide spectrum     of histopathologic entities and biologic behavior, ranging from benign to malignant.     Substantial morphologic overlap restricts the accuracy in diagnosing specific type of cystic     lesion in spite of recent advances in diagnostic modalities. It is a challenging issue to     differentiate each cystic lesion and make a management plan since cystic lesions that are     relatively common and asymptomatic may possess malignant potential. Although inflammatory     pseudocysts were thought to account for 80-90% of cystic lesions of the pancreas, with cystic     tumors accounting for the remaining,10 the latter may occur much more frequently than     traditionally estimated.      To date, surgical resection is generally recommended for malignant and potentially malignant     lesions. However, surgical resection of the pancreas still carries substantial morbidity and     sometimes mortality, especially for the cystic lesion located in the head portion. Therefore,     management should be individualized by risk-benefit analysis for each patient.      Recently, a pilot study of EUS-guided ethanol lavage for cystic tumors of the pancreas     reported that complete resolution was achieved in only one-third of patients even though     epithelial lining ablation was demonstrated in all resected specimens. Therefore, more     effective treatment modalities or ablation agents are required to improve treatment     responses. Intratumoral or intraperitoneal injection of chemotherapeutic agent has been used     for endobronchial lesions of lung cancer, brain tumors and advanced ovarian cancer.13-16     EUS-guided injection of antitumor material has been reported in advanced pancreatic cancer.     Although local injection of chemotherapeutic agents into pancreatic cystic tumors has not yet     been reported, it is reasonable to suggest that such an approach may have an additive effect     on ablation of the epithelial lining of cystic tumor when combined with ethanol lavage.      Paclitaxel, a widely used chemotherapeutic agent, inhibits cell processes that are dependent     on microtubule turnover. Due to its highly hydrophobic nature,19 paclitaxel is expected to     exert its effect longer when instilled within a closed cavity such as a cyst. The hydrophobic     and viscous nature of paclitaxel may reduce the possibility of it leaking through a puncture     site and causing complications.      The present study evaluated safety, feasibility and response following EUS-guided ethanol     lavage with paclitaxel injection (EUS-EP) for treating cystic tumors of the pancreas.   "
216865|NCT00689728|"     The purpose of this study is to explore whether LY2127399 is effective in relieving signs and     symptoms of RA in patients with a history of inadequate response or intolerance to at least 1     TNFα inhibitor therapy. Examples of these TNFα inhibitor therapies that are currently on the     market include Enbrel® (etanercept), Remicade® (infliximab), and Humira® (adalimumab).   "
216866|NCT00689741|"     The purpose of this phase IIB MedImmune-sponsored study was to evaluate the efficacy of the     HPV-16/18 VLP vaccine in the prevention of infection with HPV-16 and/or HPV-18 in adolescent     and young adult women. A vaccine that prevents, or even reduces, the incidence of the common     types of high-risk HPVs, particularly HPV-16 and HPV-18, could result in significant     reduction in the incidence of cervical cancer and cancer-related mortality, as well as a     reduction in the incidence of surgical procedures following abnormal Pap smears.   "
216867|NCT00689754|"     Upper gastrointestinal tract hemorrhage (UGIH) remains a major cause of morbidity and     mortality . Nasogastric aspiration (NGA) is routinely performed in patients with UGIH to     obtain important clinical data and make therapeutic decisions. But routine use of NGA remains     controversial with studies reporting its usefulness and its redundant clinical information.     Early esophagogastroduodenoscopy (EGD) is recommended by most gastrointestinal societies to     allow for risk stratification and to perform endoscopic treatments. The results of the NGA     may assist to differentiate between high-risk versus low-risk lesions. Our hypothesis is that     presence of NGA can identify lesions that require endoscopic treatment and provides important     clinical information to guide the treating physician. In addition, we hypothesized that the     results of the NGA influence the clinical decision of the treating physician regarding the     prediction of the need for endoscopic therapy. This observational randomized cross-sectional     study will enroll consecutive patients with presumed UGIH and randomized them to NGA and no     NGA recording its results. All patients will receive an EGD and its results will also be     recorded. Subsequently, we will evaluate if the NGA is important in identifying     endoscopically significant lesions. The information gained will help guide clinicians     evaluating patient with UGIH.   "
216868|NCT00689767|"     This First In Man study is a prospective, multicentre, single blind, randomized, controlled     clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the     CINATRA™ Coronary Stent System. The study will enroll up to 100 evaluable patients at up to 7     sites. Clinical follow up will occur at 1 month, 6 months, and 1, 2, 3, 4 and 5 years post     procedure. Repeat angiography and IVUS will be performed at the 6 month follow up time point     for all subjects.   "
216869|NCT00689780|"     A Phase I, Multi-Centre, Randomised, Double-blind, Placebo-controlled Study to Investigate     the Safety, Tolerability and Pharmacokinetics of AZD1940, Including an Interaction Study,     After Administration of Oral Multiple Ascending Doses in Adult Subjects with Chronic Low Back     Pain   "
216870|NCT00689793|"     The purpose of this study is to determine the subjective response of iron substitution     (Tardyferon®) on fatigue in women blood donors with a mean serum ferritin < 30ng/ml and to     assess variation of ferritin and hemoglobin after a blood donation.   "
216871|NCT00689806|"     This study has two purposes:        1. to determine whether lovastatin, a commonly used medication to lower cholesterol in the          blood, can produce beneficial changes in airway inflammation and in the airway smooth          muscle        2. to examine whether lovastatin will have favorable changes in asthma symptoms of patients          with moderate or severe asthma.   "
216883|NCT00689962|"     I hypothesize that absorbable screw fixation of the foot's Lisfranc ligaments does not yield     significant differences in postoperative foot stability, ligament function, and symptoms when     compared to steel screw fixation. In addition, absorbable screw fixation of the Lisfranc     ligaments offers the advantage that a second surgical procedure to remove the screw is not     necessary.   "
216910|NCT00690313|"     Antibiotic eye drops are being used before and after intravitreal injections. Currently there     is no study indicating the benefit of there usage or their dosage.      In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior     to the injection versus 1 day prior to intravitreal injection.   "
216914|NCT00690365|"     This is a single-arm, phase IV, open-label, prospective, non interventional study in     approximately 600 patients that will be followed for 6 months in order to evaluate the safety     and efficacy of quetiapine. Patients will be switched over a 4 to 7 day cross-titration     period from their previous antipsychotic medication to quetiapine according to the approved     SPC.   "
216915|NCT00690378|"     The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the     treatment of complicated urinary tract infections as compared to a comparator group.   "
216916|NCT00690391|"     The purpose of this study is to define if palliative surgery in patients with cancer improves     quality of life and prognosis.   "
216872|NCT00689819|"     This project will evaluate the clinical and cost effectiveness of a novel, multidisciplinary     approach to identify and treat pre-clinical cardiac dysfunction (PCCD) in asymptomatic     hypertensive patients identified in a single center urban emergency department. Premature     onset of pressure-related cardiac complications of hypertension (especially heart failure)     has important implications for long-term survival, quality of life and healthcare costs. This     project will target patients who have already developed pressure-related cardiac structural     abnormalities yet remain symptom free. These individuals are at tremendous risk for     progression to clinically overt heart failure and its associated consequences. We hypothesize     that detection and treatment of patients with hypertension who have pre-clinical structural     cardiac damage will enable forestallment of the disease process and offer the opportunity to     reduce the burden of cardiac morbidity associated with hypertension. This project will     implement a program to prospectively identify PCCD (using echocardiography) and provide     treatment. At present, the optimal blood pressure goal for patients with PCCD is unknown so     this study will randomize patients to 2 levels of blood pressure control: normal, which is     consistent with current national guidelines and intensive, which will aim for a markedly     lower blood pressure (< 120/80). Enrolled patients will receive active treatment and     follow-up for 1 year. At the end of 1 year, we will evaluate: 1) the ability of this program     to achieve blood pressure goals; 2) the cost effectiveness; and 3) the proportion in each     blood pressure group who have evidence of disease regression on echocardiography.   "
216873|NCT00689832|"     Children with atopic eczema and a poor response to topical corticosteroid applied either     Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more     weeks once a day if needed.   "
216874|NCT00689845|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as rituximab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Giving rituximab together with one of five different     combination chemotherapy regimens may kill more cancer cells.      PURPOSE: This clinical trial is studying giving rituximab together with combination     chemotherapy to see how well it works in treating patients with primary mediastinal diffuse     large B-cell lymphoma.   "
216875|NCT00689858|"     TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase     I study in healthy Volunteers were designed   "
216876|NCT00689871|"     Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women     undergoing primary augmentation, primary reconstruction, or revision of existing breast     implants.   "
216877|NCT00689884|"     The purpose of this study is to determine the efficacy of Pegfilgrastim in the mobilization     of autologous peripheral blood stem cells (PBSCs), defined as cell yield ≥ 3 x 10e6 CD34+/kg     and to assess the costs related to Pegfilgrastim use in the mobilization of autologous PBSCs.     Also to determine the side effects of Pegfilgrastim in the mobilization of autologous     peripheral blood stem cells.   "
216878|NCT00689897|"     The objective of this study is to evaluate the associations between deqi, the effects of     acupuncture and personality in primary dysmenorrhea and to characterize the nature of the     deqi phenomenon on terms of the prevalence of sensations as well as the uniqueness of the     sensations underlying the deqi experiment.   "
216879|NCT00689910|"     This study will evaluate the pharmacokinetic disposition of raltegravir in pregnant HIV-1     infected women. These results will be compared to pharmacokinetic data obtained following     pregnancy as well as to studies previously carried out in nonpregnant women and male     patients. By determining the disposition characteristics for this specific patient     population, antiretroviral (ARV) dosing can be optimized during pregnancy. Appropriate dosing     is necessary to minimize adverse effects, slow progression of disease, and further reduce the     risk for vertical transmission. Data will also be obtained on genital tract penetration and     placenta transfer of raltegravir to the newborn.      The subjects enrolled in this study will take an antiretroviral based regimen containing     raltegravir twice daily both during and after their pregnancy. The specific regimen will be     chosen by their own primary care provider based on their antiretroviral history and     resistance testing. They will undergo a series of blood sampling for pharmacokinetic analysis     over 12 hours on two occasions; a) during their 3rd trimester and b) approximately 3 months     postpartum. Concentrations of raltegravir in the infant will be assessed by cord and infant     blood sample at delivery and a blood sample at approximately 3 months of age.      Hypothesis: The pharmacokinetic exposure of raltegravir as measured by the 12 hour area under     the plasma concentration versus time curve (AUC0-12h) during third trimester pregnancy is     similar to the AUC0-12h estimated three months post-partum.   "
216880|NCT00689923|"     Th low viscosity cement injection is safe in vertebroplasty procedure with Comparacle out     come in pain relief.   "
216881|NCT00689936|"     The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose     dexamethasone to that of the combination of melphalan, prednisone and thalidomide.   "
216882|NCT00689949|"     The major objective of the proposed study is to demonstrate the suitability of new markers     for folate status in humans, which avoid blood sampling, as required for the established     marker RBC folate concentration, but can be obtained from spot urine samples. For this reason     urine and blood will be collected from volunteers, twice at baseline and in a subgroup after     6 and 12 weeks of intake of a folic acid supplement      Specific hypotheses to be tested:      Correlation study:        -  The 24 h urinary excretion of total p-ABG, as extrapolated via urinary creatinine          concentration from the total p-ABG concentration in a spot sample is significantly          correlated to RBC and plasma folate levels in the studied subjects        -  The 24 h urinary excretion of FIGLU, as extrapolated via urinary creatinine          concentration form the FIGLU concentration in a spot sample is significantly correlated          to RBC and plasma folate levels in the studied subjects      Intervention study:      Changes in folate status (RBC folate) after supplementary intake of folate result in     increased urinary excretion of total p-ABG and FIGLU in subjects identified with a low folate     status and in subjects identified with a high folate status among the study participants of     the correlation study   "
217950|NCT00704379|"     The purpose of this study is to examine the efficacy of sertraline to prevent the onset of     mood and anxiety disorders during the first six months after traumatic brain injury.   "
216887|NCT00690014|"     The process of drug elimination that occurs within the kidneys is complex, and involves     filtration, secretion and absorptive mechanisms. Many drugs, metabolites and toxins,     including organic anions and cations, rely on renal mechanisms for elimination from the body.     Failure to recognize the contribution of renal mechanisms involved in drug elimination during     the drug development process can result in drug interactions or toxicity in clinical trials.     This is increasingly important due to the use of OAT1 inhibitors such as probenecid that are     being used in adjuvant treatment regimens. Thus, in order to more fully understand the     effects renal disease, drugs and nephrotoxins on the renal transport pathways of tubular     secretion in humans, novel approaches that incorporate both in vitro (experimental) as well     as clinical observations (clinical trial), also called in-vitro/in-vivo correlations (IVIVC)     need to be developed. These methods can then be used to identify and evaluate specific kidney     probe drugs that undergo extensive tubular secretion. Such approaches are needed to     characterize drug clearance by tubular mechanisms and to identify potentially significant     drug-drug interactions prior to exposure to patients in Phase 2 and 3 clinical trials. This     investigator-initiated pilot project aims to determine the pharmacokinetics of selected     FDA-approved compounds (PAH, iothalamate) for use in IVIVC model development. The proposed     research is innovative, because it involves a translational approach to development of an     IVIVC model applied to renal drug clearance. It is our expectation that the resultant     approach will further our understanding of pharmacogenomics, inter-subject variability and     renal drug clearance. This approach will generate important new information regarding in     vitro drug-drug interactions in light of many new and potent OAT1 blocking agents being     introduced for the treatment of human diseases. In future studies, we hope to fully     characterize the effects of diseases such as diabetes, hypertension, and nephropathy on renal     drug transport mechanisms using IVIVC models. We expect that results from this NIH-funded     study will provide needed preliminary data to design future pharmacogenomic and drug     interaction studies in humans.   "
216888|NCT00690027|"     In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on     mortality rate, duration of life, quality of life, and economic costs of treatment of:        -  Emergency portacaval shunt, and        -  Emergency and long-term endoscopic sclerotherapy.   "
216889|NCT00690040|"     The purpose of this study is to compare between single balloon catheter and double balloon     catheter for ripening the cervix among pregnant with unfavorable cervix.   "
216890|NCT00690053|"     Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients     having a hypoxic tumour who could be treated with specific anti-hypoxic treatments such as     bio-reductive drugs or hypoxic radio-sensitizers. Several 2-nitroimidazoles to which the     compound to be tested, HX-4, belongs, labelled with Fluor-18 have already been used in     patients. However, bad image quality and unpredictable kinetics limit their use. In extensive     pre-clinical models, the combination of HX-4 labelled with Fluor-18 is a promising non-toxic     new probe to determine hypoxia.   "
216891|NCT00690066|"     The purpose of this study is to establish the safety and efficacy of multiple administrations     of PROCHYMAL® in subjects recently diagnosed with type 1 diabetes mellitus.   "
216892|NCT00690079|"     The study is being performed in order to learn more about the safety and tolerability of     AZD1386. AZD1386 is primary intended for treatment of chronic pain.   "
216893|NCT00690092|"     Adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. The skin test     antigen was evaluated in three different populations of adult volunteers to determine the     safety and efficacy of the product in the assessment of delayed-type hypersensitivity to     Coccidioides immitis. Induration greater than or equal to 5 mm after 48 hours was considered     positive for exposure to C. immitis.   "
216894|NCT00690105|"     Patients with facial atopic eczema and a poor response to topical corticosteroid applied     either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3     more weeks once a day if needed or change for the other ointment.   "
216895|NCT00690118|"     Primary objective:      Efficacy of pioglitazone (45 mg/day) as add-on therapy to standard therapy with riluzole in     patients with ALS compared to placebo in terms of survival (mortality defined exclusively as     death).      This is a prospective, multicentre, randomised, stratified, parallel-group, double-blind     trial comparing placebo with 45 mg pioglitazone as add-on therapy to 100 mg riluzole in ALS     in 220 enrolled patients. For entry, the El Escorial Criteria for diagnosis will be used. The     duration of treatment will be 18 months. The primary endpoint will be subjected to a     confirmatory analyses. Secondary variables will be incidence of tracheotomy or non-invasive     ventilation, ALS Functional Rating Scale, Quality of life and safety variables.   "
216896|NCT00690131|"     This 3-year study will involve the design and small-scale clinical trial of a behavioral     treatment program for smoking cessation in people with severe mental illness (called     Behavioral Treatment for Smoking Cessation in Serious and Persistent Mental Illness or BTSCS)     in two psychosocial rehabilitation programs (PRPs) in Baltimore. Our aims are: (1) Develop     intervention materials and examine feasibility, acceptability, and safety; (2) Measure the     effects of the intervention at post-treatment and 3-month follow-up on rates of smoking     cessation, number of quit attempts, rates of smoking reduction and intention/motivation to     quit smoking.   "
216897|NCT00690144|"     The purpose of this study is to determine whether the use of high-fidelity simulation in     health care education is an effective training and evaluation model.   "
216898|NCT00690157|"     Main goal of the study is the risk stratification of patients with advanced heart failure     referred for orthotopic heart transplantation (OHT) according to HFSS score, other risk     factors and biological markers and verification of their prognostic value in Polish     population.   "
216899|NCT00690170|"     This study examines the interactive effects of ketamine and nicotine.   "
217248|NCT00697853|"     This study is undertaken to assess the immune response and safety profile of 4 lots of the     novel adjuvanted hepatitis B vaccine that were formulated following different processes, with     Engerix™-B as the control vaccine   "
216911|NCT00690326|"     Type 2DM is present in the populations of almost all the countries in the world and is a     significant disease burden in most countries .Evidences suggest that population in India     develop Type 2 DM at an increasing rate as they reject their traditional life styles.      Awareness and knowledge regarding Diabetes and role of physical inactivity in producing     complications is still grossly inadequate( Mohan. D, Raj.D Awareness and knowledge of     Diabetes in Chennai.The Chennai urban Rural Epidemiology study(CURES-9)J Assoc. Physicians     India 2005 April;53:283-7).Exercise is a low cost , non pharmacological intervention that has     been shown to be effective in metabolic control. Exercise is still vastly under-utilized in     the management of Type 2 DM.      Most proximal behavioral cause of insulin resistance is physical inactivity.(Michael J.     LaMonte, Steven N. Blair et al.( Physical activity and Diabetes prevention J Appl Physiol.     99: 1205-1213,2005)      This study was designed to promote physical activity among type 2 DM female subjects aged     35-65 yrs attending Diabetic clinic of a tertiary care hospital in Kerala.   "
216900|NCT00690183|"     Increased numbers of circulating stem cells and physical activity are both associated with     improved health in older persons. This pilot study is the initial step in developing a     collaborative, translational research project investigating whether physical activity may in     part exert a positive influence on aging via the mobilization of stem cells. The specific aim     of this pilot project is to collect preliminary data to explore the relationship between     physical activity and stem cell populations found in the blood and to determine the variance     in the number of circulating stem cells. We hypothesize that stem cell decrease with age, but     that persons who are more physically active will have a higher number of stem cells in the     blood. A maximum of 40 persons will be recruited to participate. Persons are eligible to     participate if they are age 60 or older, haven't been hospitalized recently, do not have an     immunologic or blood disease, do not have an infection, and are not undergoing chemotherapy.     Subjects will have 2 visits to the UNMC Clinical Research Center (CRC). The first assessment     will include an evaluation of health, physical activity and lifestyle via questionnaires.     Height, weight and abdominal girth will be measured, and blood will be drawn for immune and     stem cell assessment. Subjects will be given a pedometer and accelerometer to wear daily for     7 days. Subjects will return to the CRC for a second visit at which the pedometer and     accelerometer will be returned and blood will be drawn. Stem cell and immune assays will be     repeated to evaluate the variability of these measures over time. The correlation between     stem cell numbers and physical activity will be analyzed. The data will be used to perform     sample size calculations for the development of future studies.   "
216901|NCT00690196|"     Breast Cancer is the most common cancer in women. After completion of successful therapy, may     behavioral symptoms persist with over 20% of breast cancer survivors reporting chronic     insomnia of greater than 6 months duration that fulfils clinical diagnostic criteria with     associated functional limitations, decreased quality of life, and possible effects on     long-term survival. Behavioral interventions are highly efficacious in the treatment of     insomnia and preferred over hypnotic medication when insomnia is chronic. However, insomnia     studies conducted in cancer are scarce. The proposed research builds upon program of study     that has examined the efficacy of mind-body intervention, Tai Chi Chih (TCC), on health     outcomes including sleep impairments. Preliminary studies show that TTC, a slow moving     meditation, contributes to improvement in subjective sleep quality, sleep amounts and sleep     efficiency. The investigators have further found that sleep, fatigue and proinflammatory     cytokine activity are reciprocally related and that TCC decreases the mechanism through TCC     carries its effects on sleep outcomes.   "
216902|NCT00690209|"     Surgical revascularization has proven its efficacy in term of morbidity and mortality in     patients with multivessel coronary disease and poor left ventricular function. Nevertheless,     if left ventricle is severely dilated, the improvement of global contractility and reduction     of volumes is frequently absent after CABG even if substantial amount of myocardial viability     is present. A value of > 140 ml for end systolic volume has been proposed as the cut off for     the absence of recovery after revascularization.      Recently, a reduction of cardiac volumes and improvement of regional and global contractility     has been demonstrated in patients with advanced ischemic heart disease, severe dilation of     left ventricle and poor candidates for revascularization after injection of stem cells in     territories with residual viability.   "
216903|NCT00690222|"     The purpose is to determine if an intracameral solution of 0.2% tropicamide and 2%     phenylephrine can dilate the pupil for cataract surgery as well as pre-operative topical 1%     tropicamide and 5% phenylephrine. We will be looking at two separate groups of patients,     those with and those without pseudoexfoliation syndrome.      We will be looking at how each method affects the size of the pupil at the beginning and at     the end of cataract surgery. In addittion, we will look at what effect the two different     methods have on blood pressure and heart rate in the pre-operative, peri-operative and     post-operative periods.   "
216904|NCT00690235|"     Primary Objective:      To test the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight     gain in persons with schizophrenia who are currently taking either drug; measures of the     metabolic syndrome will be evaluated as well.      Secondary Objective To evaluate the action of pramlintide on cognition in schizophrenia and     on psychotic symptoms of the illness.   "
216905|NCT00690248|"     Observational, non-interventional, transversal, multicenter, open label (No treatment is     involved). The primary objective is to detect the prevalence of depressive symptoms in     bipolar patients admitted to a psychiatric Unit due to an acute mania episode. Secondary     objectives include 1) to evaluate, the relationship between depressive symptoms and severity     of mania; 2) to evaluate, the relationship between depressive symptoms and anxiety; 3) to     evaluate, the relationship between depressive symptoms and psychotic symptoms; 4) to     evaluate, the relationship between depressive symptoms and insight; 5) to evaluate, the     relationship between depressive symptoms and clinical global impression; 6) to evaluate, the     relationship between depressive symptoms and previous treatment with antipsychotics (whatever     the antipsychotic was); 7) to evaluate, the relationship between depressive symptoms and     length of admission; 8) to evaluate factors (demographic, evolution…) which could be involved     in the presence of depressive symptoms within an acute manic episode; 9) to evaluate, the     difference on the initial prescription due to the detection of depressive symptoms; 10) to     evaluate, if exists, differences on the previous psychiatric diagnosis in patients with and     without depressive symptoms. The primary endpoint is score of the MADRS (Montgomery-Asberg     Depression Rating Scale) in bipolar patients with acute mania   "
216906|NCT00690261|"     The purpose of this study is to evaluate the correlation between M1/M2 phenotype of tumor     associated macrophage (TAM) in lung cancer patients and clinical outcome.   "
216907|NCT00690274|"     To evaluate the cognitive enhancing effect of BF2.649 and to evaluate the effect of BF2.649     on symptom severity in persons with schizophrenia or schizoaffective disorder.   "
216908|NCT00690287|"     The purpose of this study is to assess the effect of AZD6370 on blood sugar and to study     safety and tolerability in patients with type 2 diabetes.   "
216909|NCT00690300|"     The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in     patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of     a palliative first line therapy.   "
219333|NCT00715286|"     To determine the impact of Neoadjuvant chemotherapy on surgical debulking rate, overall and     disease-free survival and quality of life (QOL) in patients with advanced EOC.   "
216918|NCT00690417|"     The purpose of the research is to describe vitamin D levels and bone status in a rural     Wisconsin population. It is probable that individuals of varying age and ethnicity require     different amounts of D to achieve optimal status. These likely scenarios will be explored in     various populations. We hypothesize that the increase in serum 25(OH)D resulting from daily     D3 ingestion is less pronounced with advancing age and different in Native than Caucasian     Americans. In addition, the women in the middle age group, between the ages of 55 and 65,     will have ultrasound tests completed to assess the impact of the Vitamin D supplementation on     cardiovascular health.   "
216919|NCT00690430|"     The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of     paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are     inadequately controlled by currently available somatostatin analogues.   "
216920|NCT00690443|"     Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus     monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy     parameter is percent change in LDL-C after 8 weeks of therapy.   "
216921|NCT00690456|"     The primary objective of the study is to determine the effect of rimonabant 20 mg daily when     added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in     patients with type 2 diabetes.      Secondary objectives include evaluation of other markers of glycemic control, lipid profile,     body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when     added to metformin over a period of 47 weeks.   "
216922|NCT00690469|"     This laboratory study is looking at genetic mutations and environmental exposure in young     patients with retinoblastoma and in their parents and young healthy unrelated volunteers.     Gathering information about gene mutations and environmental exposure may help doctors learn     more about the causes of retinoblastoma in young patients.   "
216923|NCT00690482|"     The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic     Obstructive Pulmonary Disease   "
216924|NCT00690495|"     The purpose of the study is to determine whether a modified propofol preparation shows any     effect on the incidence of injection pain in adults undergoing elective surgery under general     anesthesia.      Study hypothesis: The use of a modified propofol preparation will reduce the incidence of     injection pain in the study group.   "
216933|NCT00690612|"     The HIP study is designed to follow the clinical experience of young hypertensive children     receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11     years old. The study is open label with no concurrent control group. To be eligible for HIP,     children must have completed Study 328 without discontinuation due to a study drug-related AE     and in the investigator's opinion, have an on-going clinical indication for an orally     administered suspension of candesartan cilexetil to control blood pressure. Children will     return to clinic every 3 months (more frequently at the investigator's discretion) for safety     and efficacy evaluations. Safety will be monitored by serum chemistries, urinalyses,     echocardiograms and by physical examinations at specified clinic visits. Blood pressure and     heart rate will be measured at each clinic visit. Study drug is administered orally once a     day. Investigators determine the efficacious dose ( 0.05 mg/kg; 0.2 mg/kg; 0.4 mg/kg) on a     vist-by-vist basis depending on the child's BP response. It is anticipated that study dose     will align closely with the effective anti-hypertensive dose determined in Study 328. If the     child's hypertension is not well-controlled, dose adjustments up to a maximum of 0.4mg/kg/day     and/or the addition of other antihypertensive medications are permitted, with the exception     of other angiotensin receptor blockers. The HIP study offers eligible children up to two     additional years of treatment with the liquid formulation of Atacand.   "
216925|NCT00690508|"     Background:      The intra-tracheal intubation of a patient is a most delicate medical procedure performed     under often life-threatening conditions in in- and out-of-hospital acute care medicine.     Correct placement of the tube after intra-tracheal intubation is thus absolutely vital.     Incorrect position of the tube can be fatal through loss of the airway or through barotrauma     of the airway and lungs possibly leading to cardiac arrest. The mid-tracheal point of the     trachea is the perfect place for an intra-tracheal tube to be to guarantee ventilatory     support without problems for neonates and children. Supra-sternal palpation of the tube tip     (SSTTP) is a method validated in newborns only, which has a very high accuracy rate in     placing the tube-tip at the mid-tracheal point. In addition, it is easy to learn and without     side effects. In infants and children, SSTTP is widely used in Switzerland although never     validated in a controlled trial.      Objective:      To validate supra-sternal palpation of the endo-tracheal tube tip as a valuable measure to     correctly determine the depth of intubation in infants from one month of age to children up     to eight years of age, when correct depth of the tube-tip is defined as tube-tip being within     plus/minus 0.25cm of the line between the medial points of the claviculae (IMP) for infants     and within plus/mius 0.25 respectively plus/mius 0.38cm for toddlers and children.      Hypothesis:      Supra-sternal Tube Tip Palpation (SSTTP) is a valid and easy to perform measure to identify     the correct depth of intubation after oral or nasal tracheal intubation in infants, toddlers     and children. Correct depth is defined as tube tip placed within plus/minus 0.25cm of the IMP     for infants and within plus/minus 0.25 respectively plus/minus 0.38cm for toddlers and     children.      Study design and methods:      Sixty-four toddlers and children and 18 infants will be enrolled into the study. Three     Respiratory Therapists (RT) from the Pediatric Intensive Care Unit (PICU) will be trained in     SSTTP before the start of the study. Successful training of the RTs will be confirmed by     x-ray before final qualification as Expert in SSTTP. All patients with an intubation     requiring a post-manipulation x-ray in the PICU at CHEO will be enrolled into the study. No     randomization will be necessary; all infants and children in need of an intubation will be     enrolled into the study. Potential patients will be excluded if there is presence of     anatomical malformation or any other reason that would prevent accurate SSTTP, or if there is     no Expert in SSTTP available. The location of the tip of the tube after SSTTP will be     measured on standard post-intubation x-rays by a radiologist. The tube-tip location     difference will be calculated as the difference between the actual tube-tip location and the     IMP.   "
216926|NCT00690521|"     The purpose of this research study is to compare the effectiveness of hydrochlorothiazide or     metolazone in combination with furosemide. Patients with heart failure suffer from swelling     because of too much fluid in the body. Furosemide, hydrochlorothiazide, and metolazone are     all water pills used to treat the swelling. For most patients, taking furosemide alone is     successful. However, sometimes patients need to add another water pill. Doctors usually add     either metolazone or hydrochlorothiazide. It is not clear which water pill is better when     added to furosemide. The purpose of this study is to determine which water pill when added to     furosemide is the best at reducing excess fluid in the body.   "
216927|NCT00690534|"     Muscle loss with aging is a significant contributor to disability in older people. Our     general hypothesis is that loss of muscle with aging, known as sarcopenia, may be due to     inability of muscle to grow in response to insulin. Our goal is to determine the mechanisms     underlying this age-related insulin resistance of muscle proteins, which will allow us to     define in the future specific interventions to target this defect and provide the scientific     basis for the prevention and treatment of sarcopenia.   "
216939|NCT00690690|"     The overall goal of this study is to develop and evaluate a brief, video-based, group-level     intervention designed to reduce sexual risk taking among culturally diverse English- and     Spanish-speaking Latino men who have sex with men (MSM).   "
216928|NCT00690547|"     Force enhancement (FE) describes the phenomenon of strength potentialization of a muscle cell     or the complete muscle during and after active extension compared to the strength of an     isometric contraction with same muscle length. The underlying physiological mechanism of this     phenomenon is not completely known today. In vitro trials indicate that the interaction of an     active and a passive component on the cellular level are responsible for the higher strength     measurements. So far FE could be shown in vitro and in vivo on muscle fibers and small human     muscles. Further research is needed for verification of the existence of FE in voluntary     motor activity in everyday life. In order to approach this objective the investigators will     scrutinize the functionality of the deliberately activated musculus (m) quadriceps femoris     during and after active extension on the basis of in vivo studies.   "
216929|NCT00690560|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and     cyclophosphamide, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may     be effective in treating cancer and blocking the body's immune response. Monoclonal     antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or carry cancer-killing substances to them. Giving     chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer     cells.      PURPOSE: This phase II trial is studying how well giving doxorubicin together with     vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y     90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell     lymphoma.   "
216930|NCT00690573|"     To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with     Polyarticular Juvenile Rheumatoid Arthritis   "
216931|NCT00690586|"     The purpose of this study is to describe the hormones controlling fluid balance in pediatric     patients with nephrotic syndrome. Further more, an analysis of the urinary and plasma     proteins will be done using proteomics. Different composition of proteins in the urine or     plasma might indicate if the patients will respond to treatment or not.   "
216932|NCT00690599|"     The aim of the study was to evaluate the socioeconomic patient's profile and their level of     satisfaction in the general dental practice clinic. A cross-sectional quantitative study was     accomplished with 80 patients assisted at the referred service. A solely-applied     questionnaire was used regarding the following aspects: structure and environment, fear and     anxiety, reliability, empathy and commitment, resolutivity and quality of the accomplished     services. It was observed that the assisted patients' profile consisted predominantly of a     female sample (71,2%), that completed the medium learning (31,2%) and/or that didn't finish     the fundamental level (26,2%). Moreover 50% of them presented a family income of 1 to 2     minimum salaries and 41,2% were unemployed. As the quality of the rendered technical service,     nearly 70% of the users considered it great, as well as the clinic's structure and     environment. Regarding the satisfaction with to the received treatment, 76,2% of the     interviewees gave the maximum score of 10 and 95% would recommend the attendance to others.     It is concluded that the patients are satisfied with the clinical attendance accomplished by     the students in the general practice dental clinic at UNIFOR, in what refers to its technical     and functional quality.   "
216965|NCT00691041|"     The purpose of the study is to examine the efficacy of a network-oriented outreach     intervention to reduce HIV and sexually transmitted infection (STI) related risk behaviors     among African American men who have sex with men (AA MSM)and their social network. The     hypothesis is to determine whether the new intervention is more efficacious at reducing high     risk sexual behaviors than the standard normal of care provided to the public (a single     session of individual HIV counseling and testing.   "
216934|NCT00690625|"     This study is designed to evaluate the effectiveness of topical application of omega-3 fatty     acids (6% by volume) containing cream on persons with a TMD disorder, specifically with a     diagnosis of Myofacial Pain. Omega-3 fatty acids have minimal side effects when applied     topically. If Omega-3 fatty acids used in this study are shown to reduce myofacial pain then     this formulation could potentially be used for treatment of TMD patents with myofacial pain     in the future. Omega-3 fatty acids are natural ingredients with almost no side effects.     Topical application can lead to fewer side effects than systemic medications. In addition,     there is no substantial morbidity & mortality associated with topical application of Omega-3     fatty acids. It is hypothesized that subjects receiving topical application of omega-3 fatty     acids will demonstrate reduced subjective masseter muscle pain in comparison to subjects     receiving placebo cream. This is a pilot study to assess the topical application of Omega-3     fatty acids on muscle pain in the muscles of mastication.   "
216935|NCT00690638|"     A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate     Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus   "
216936|NCT00690651|"     After a patient has fractured an ankle that then requires surgery, the recommendation is to     remain in bed, with the operated leg elevated on pillows for 48 hours. This is a     precautionary measure, as yet unsubstantiated by research, which is thought to minimize ankle     swelling that can inhibit the healing of the surgical wound. However, prolonged bed rest can     lead to other complications such as blood clots in the lungs or leg veins, or chest     infections such as pneumonia. Prolonged bed rest is also known to cause weakness and a loss     of fitness such that recovery may be slower. In this research the investigators will be     randomly allocating patients to mobilize within 24 hours post operatively or to rest in bed     for 48 hours with their leg well elevated. The investigators will measure length of stay and     wound healing and integrity at 14 days. This study aims to investigate whether getting     patients out of bed within 24 hours of surgery can accelerate recovery and reduce acute     hospital length of stay without affecting wound healing. If bed rest for 2 days is not     necessary, there will be benefits for the patient in terms of general health and ability, and     for the hospital in terms of cost savings through shorter lengths of stay and patient through     put. The investigators already know that early mobilization is beneficial following other     types of orthopedic surgery such as hip fractures. This study aims to investigate if early     mobilization following surgical management of ankle fractures is safe with specific regard to     wound integrity and wound outcomes. This study will also investigate the effect of earlier     mobilization on the length of time spent in the acute hospital and for those discharged     directly home, the amount and type of support required. If early mobilization is found to be     safe for wound healing and results in shorter in-hospital stays, this research will provide     the confidence to endorse a change to current clinical practice.   "
216937|NCT00690664|"     The purpose of this research study is to better understand African American hair and scalp,     its biologic appearance and how this relates to African Americans' perceptions of their hair     and scalp health. Since most hair studies have looked at Caucasian hair and scalp, we will     use a population of Caucasian subjects for comparison in evaluating various hair and scalp     parameters.   "
216943|NCT00690755|"     The investigators are examining the activation of insulin signaling factors in skeletal     muscles of human diabetics. The investigators are characterizing the defects in signaling,     and are examining the effects of anti-diabetic agents and exercise on signaling to glucose     transport biochemical machinery and whole body glucose disposal.   "
216944|NCT00690768|"     The purpose of this study is to compare the amount of intraoperative intraocular bleeding     during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD)     with and without preoperative intravitreal bevacizumab treatment.   "
216945|NCT00690781|"     The purpose of this study is to minimize the loss of lean body mass that occurs during a     weight-loss program in obese people by changing the nature of ingested protein and the     pattern of protein feeding   "
216946|NCT00690794|"     The purpose of the study is to compare two ophthalmic solutions in patients with open-angle     glaucoma or ocular hypertension.   "
216947|NCT00690807|"     PH-10 is a formulation of rose bengal disodium (RB) for topical administration to the skin.     PH-10 is capable of undergoing photochemical reactions when activated by ambient light. This     phase 2 study will assess whether topical PH-10 applied once daily to mild, moderate or     severe areas of atopic dermatitis (including atopic eczema) may ameliorate inflammation of     the skin when activated by ambient light.   "
216948|NCT00690820|"     This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat     and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to     Cystic Fibrosis.   "
216949|NCT00690833|"     The purpose of this research study is to better understand how this study drug works when     people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug     Administration (FDA) for atopic dermatitis.   "
216950|NCT00690846|"     The purpose of this research study is to see if Humira (adalimumab) is effective and safe in     the treatment of pyoderma gangrenosum.   "
216963|NCT00691015|"     RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.     It may also stop the patient's immune system from rejecting the donor's stem cells. The     donated stem cells may replace the patient's immune cells and help destroy any remaining     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can     also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus,     and antithymocyte globulin before and after transplant may stop this from happening.      PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with     tacrolimus and antithymocyte globulin and to see how well it works in preventing     graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem     cell transplant.   "
216951|NCT00690859|"     Observational, prospective (1 year follow up), multicenter, non-interventional open label     study in order to assess the factors that predict onset of mood disorders episodes     (depression, mania, hypomania and mixed) in stabilized patients with bipolar disorder I or II     in Spain. Other objectives are        1. to describe the clinical course of illness in a cohort of patients with TB I or II:          duration, severity, polarity and seasonality        2. to describe clinical and functional situation of patients during the different phases,          evaluating prognostic meaning of subsyndromal symptoms        3. to evaluate the economical impact on health service of these patients (hospitalization,          primary care, treatments…).      Target population is ambulatory bipolar I and II patients, clinically stabilized for at least     the two months prior to recruitment and who had at least one acute episode (depressive,     manic, hypomanic or mixed) within the year prior to recruitment. The primary endpoint is the     onset of mood disorders episodes (depression, mania, hypomania and mixed) during the     follow-up period and evaluation of which factors predict onset of mood episodes   "
216952|NCT00690872|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving an infusion of a person's T lymphocytes that have been treated in the     laboratory may help the body build an effective immune response to kill tumor cells. Giving     combination chemotherapy together with laboratory-treated T lymphocytes may kill more tumor     cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine and carboplatin together     with laboratory-treated T lymphocytes works in treating patients with metastatic or locally     recurrent Epstein-Barr virus-positive nasopharyngeal cancer.   "
216953|NCT00690885|"     The purpose of this study is to determine whether lozenges containing interferon-alpha can     reduce the frequency and severity of coughing in patients with chronic obstructive pulmonary     disease (COPD) and idiopathic pulmonary fibrosis (IPF).   "
216954|NCT00690898|"     Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and     mainly due to benign tumour localized in the pituitary gland.      The disease develops insidiously, causing a gradual progression of symptoms; consequently     most patients are diagnosed in their fourth decade of life.      Administration of somatostatin analogues such as lanreotide have been shown to result in     normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement     of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate     whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the     benefits of this potential tumour shrinkage on disease symptoms and patient's quality of     life.   "
216955|NCT00690911|"     The purpose of the study is to see if Humira is effective and safe in the treatment of     sarcoidosis.   "
216956|NCT00690924|"     RATIONALE: Calcitriol may prevent lung cancer in patients with metaplasia or dysplasia of the     lungs.      PURPOSE: This clinical trial is studying the side effects and best dose of calcitriol in     preventing lung cancer in current smokers and former smokers at high risk of lung cancer.   "
216957|NCT00690937|"     A total of 120 patients will be entered in this study to assess the safety and efficacy of     enteric coated sevelamer (ECS) to lower LDL cholesterol. Patients will be randomized into two     active treatment groups, two placebo groups and one active control group.   "
216958|NCT00690950|"     Hypothesis: Dutasteride will perform better than finasteride in decreasing prostate volume,     improving symptoms based on International Prostate Symptom score,and lower pvr based on the     scientific information that dutasteride inhibits both Type I and II 5-alpha-reducatase vs.     finasteride which only inhibits the Type II enzyme   "
216959|NCT00690963|"     Patients who have inoperable non-small cell lung cancer are presently treated with     chemotherapy and radiation therapy. Despite this combined approach, the vast majority of     patients will have their cancer recur after treatment. A recurrence is not curable at this     time. Because of the sensitivity of surrounding structures to chest irradiation, it has not     been possible to give radiation doses that can cure many of these tumors. Intensity-modulated     radiation therapy is a special form of radiotherapy delivery that allows doctors to reduce     the amount of radiation dose to normal tissues and therefore reduce side effects. The     reduction of radiation side effects may allow more radiation to be delivered to tumors,     therefore improving tumor control and possibly longevity of patients. The purpose of this     study is to determine whether the combination of custom designed intensity-modulated     radiotherapy (based on individual tumor anatomy) with regular chemotherapy, will be safe     enough to allow further intensification of radiation treatment.   "
216960|NCT00690976|"     The purpose of this project is to determine the acceptability, feasibility, and the     preliminary efficacy of an HIV prevention behavioral intervention (Proyecto SOL) to reduce     behaviors associated with HIV acquisition among Hispanic men who have sex with men (HMSM).     The primary goal of the intervention is to motivate and assist participants in forming and     carrying out a Safer Options for Life plan, thereby reducing their risk of HIV acquisition     or transmission.   "
216961|NCT00690989|"     This is a retrospective review of the records of patients seen at the Kilgo Headache Clinic     in Alabama between 7/1/05 and 6/30/07. The goal of the study is to identify factors at the     time of the initial office visit that can be used to predict failure to follow-up.   "
216962|NCT00691002|"     There are few therapies suitable for the treatment of psoriasis on the face and skin folds.     As these areas are sensitive, irritation and other adverse reactions are more common than     elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once     daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus     hydrocortisone 10 mg/g with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10     mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis     vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the     safety and efficacy will be evaluated for up to 60 weeks treatment as required of     calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face     and intertriginous areas (= open-label phase).   "
216964|NCT00691028|"     The purpose of this study is to assess the efficacy, safety and pharmacokinetics of     maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with     methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis     (RA) showing an insufficient response to MTX.   "
216966|NCT00691054|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle     formulation works in treating patients with locally advanced or metastatic pancreatic cancer     that did not respond to first-line therapy with gemcitabine.   "
216967|NCT00691067|"     We propose to conduct placebo-controlled trial of the glucocorticoid receptor antagonist     mifepristone in Gulf War veterans (GWV) with chronic multisymptom illness (CMI) to examine     its effects on physical and mental health and cognitive functioning. In addition, we propose     to examine whether HPA axis biomarkers or their response to mifepristone are useful     predictors of clinical response.   "
216968|NCT00691080|"     The investigators will examine whether sleep problems in children with autism spectrum     disorder (ASD) are related to alterations in the production of melatonin (MT), a hormone that     plays an important role in regulating sleep-wake cycle. Children with ASD experience high     rates of sleep disturbances that potentially contribute to problems with thinking and     behavior. It is unclear if changes in MT production cause sleep problems in children with     ASD. MT is frequently used to treat these sleep problems; however, it has not been well     established whether MT is an effective treatment. Our hypotheses concerning MT is children     with ASD and sleep problems will have a delayed sleep-wake cycle and/or decreased MT     production. This study will compare children diagnosed with ASD to healthy control children     with no ASD diagnosis. All subjects will be recruited from one of three sites: Baylor College     of Medicine, Oregon Health & Science University and Columbia University. The investigators     will use a standardized questionnaire to determine whether the child has sleep problems. The     investigators will measure MT levels in saliva in ASD children with sleep problems and in a     group of control children without sleep problems. Total 24-hour MT production will be     determined from urine samples in these same two groups.   "
216969|NCT00691093|"     This is a observational study in patients treated with fesoterodine (Toviaz), who have failed     on previous treatment for overactive bladder. It will collect epidemiological data and     investigate the efficacy and tolerability of fesoterodine.   "
216970|NCT00691119|"     The purpose of this study is to find out if it is possible to study relaxation and     visualization therapy (RVT) with individuals that have breast cancer. We will also look at     what effects, the good and bad, RVT has when used with radiation therapy. We are interested     in how RVT may relate to energy, quality of life, stress, and the immune system. Relaxation     and Visualization therapy will lead participants through a practice of physical relaxation     and then a step by step visualization. In this study, participants will be led through an RVT     exercise, providing an interactive process. In addition, women will perform solitary RVT     exercises at home on weekends. Participants for this study will be drawn from two OHSU     physicians' regular patient base. To be sure that we are testing the effects of RVT alone, we     will use three groups. The three groups will be RVT, education, and a control. The RVT group     will receive RVT with radiation, and the education group will receive breast cancer related     health education with radiation. The third group will receive no treatment beyond radiation.     This third group is called the control. The entire study will last for approximately twelve     weeks. For the first 6 weeks, each participant will be receiving radiation therapy. We will     be particularly interested in the effects that RVT may have on energy, quality of life,     stress, and the immune system. No experimental drug or device will be used during the study.   "
217176|NCT00696917|"     This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL     vaccine and to compare their safety and immunogenicity with that of Engerix™-B.   "
216971|NCT00691132|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of phenethyl isothiocyanate may prevent lung cancer in people who smoke cigarettes.      PURPOSE: This randomized clinical trial is studying phenethyl isothiocyanate to see how well     it works in preventing lung cancer in smokers.   "
216972|NCT00691145|"     The objective of this study is to assess the efficacy and safety of 0.1% and 0.03% Tacrolimus     ointment for 12 months in adults with moderate to severe atopic dermatitis.   "
216973|NCT00691158|"     The purpose of this study is to identify how certain parts of the brain that help control     body weight respond to an infusion of hormones called leptin and amylin.   "
216974|NCT00691171|"     The purpose of the study is to examine the impact of augmented, high-quality     physician-coordinated care executed via an electronic health record (EHR)-based intervention     on quality of care for gastroesophageal reflux disease (GERD) and for gastroprotection for     patients on chronic non-steroidal anti-inflammatory drugs (NSAIDs) at increased risk for     upper GI tract ulcers and ulcer related complications.   "
216975|NCT00691184|"     In this study, the safety and pharmacokinetics of 10 % terbinafine hydrogen chloride (HCl)     nail lacquer wre investigated by comparison with vehicle control and 1% terbinafine cream   "
216976|NCT00691197|"     Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses   "
216977|NCT00691210|"     The purpose of this study is to test the safety of a combination of two anticancer medicines,     called vorinostat and etoposide, with a high dose of a vitamin called niacinamide. These     medications will be tested at different dose levels. The investigators want to find out what     effects, good and/or bad, it has on patients and their recurrent lymphoma. The first two     drugs, vorinostat and niacinamide, suppress survival signals that lymphoma cells depend on.     The third drug, etoposide can kill sensitive lymphoma cells alone or in combination with     other chemotherapy drugs. Vorinostat is an anticancer agent that been approved by the Food     and Drug Administration for use in cutaneous T-cell lymphoma. It is being evaluated in this     study in combination with other anticancer medicines for use in other types of lymphoma.     Vorinostat's use in combination with anticancer regimens is experimental. Niacinamide is a     vitamin that is investigational or experimental when given at high doses as an anticancer     agent. Niacinamide has not yet been approved by the Food and Drug Administration for use in     lymphoma. Etoposide has been approved by the Food and Drug Administration for use in     aggressive non-Hodgkin's lymphoma. However, the way it will be given in this clinical study     is experimental.   "
216989|NCT00691366|"     The purpose of this research is to study heart rate patterns in people with moderate to     severe atopic dermatitis and how itching affects those patterns.   "
217249|NCT00697866|"     The purpose of the present study is to evaluate the immunogenicity and safety of three     consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate     vaccine will be assessed using Engerix™-B as control.   "
216978|NCT00691223|"     Focal dermal hypoplasia, or Goltz syndrome, results from genetic changes, or mutations in the     PORCN gene located on the X chromosome. This neurodevelopmental disorder is characterized by     birth defects of the skin, skeleton, eyes, and in some cases other organs. Our team is     working to obtain a better understanding of how mutations in PORCN lead to the clinical     features of Goltz syndrome. We are also trying to identify the genetic change in those     patients where no mutations in PORCN have been found. We are also investigating conditions     with phenotypes similar to Goltz syndrome to determine if they also have mutations in PORCN.     We are collecting blood samples from patients and their parents. DNA from these samples is     isolated and then used for genetic testing. We also review medical records to compare     clinical symptoms with the detected mutations to determine if there is a correlation.   "
216979|NCT00691236|"     This trial will be a pilot study to find out if zoledronic acid improves the response to     chemotherapy in high grade osteosarcoma. In arm A of the study, 40 adult patients will be     randomised into two groups. One group will get standard chemotherapy and the other group will     get Zoledronic acid in addition to chemotherapy. The investigators will assess the     histological necrosis as well as disease status for up to 2 years.      In Arm B, adult patients with relapsed disease or advanced disease who are unable to take any     other therapy and are given only symptomatic care will be given 6 doses of zoledronic acid     and followed up for disease status. This will be to determine the role of zoledronic acid as     a single agent.   "
216980|NCT00691249|"     This study will test the effects of resistant starch type 4 on blood sugar and hunger in     adults with Type 2 diabetes.   "
216981|NCT00691262|"     Objective of this study is to further assess the response to treatment and safety of 0.03%     tacrolimus (FK506) ointment when used for 6 months in pediatric patients with moderate to     severe atopic dermatitis, known to be responsive to topical steroids.   "
216982|NCT00691275|"     Dehydration due to vomiting is a common complication of acute gastroenteritis in children.     Persistent vomiting following rehydration is a problem in outpatient management using oral     rehydration therapy.      Four previous studies have examined the role of the medication, ondansetron, in treating     nausea and vomiting in children with gastroenteritis and have suggested that it may be     beneficial [1-4]. A previous study has also shown that the administration of intravenous     fluid alone to children with dehydration due to gastroenteritis helps resolve nausea and     vomiting in the majority of patients [5]. None of the previous studies compared the efficacy     of intravenous ondansetron with that of intravenous fluid alone in the prevention of vomiting     . In addition, the previous studies were limited by poorly defined inclusion criteria and     outcome measures.      The proposed study seeks to more clearly define the role of intravenous ondansetron in the     management of children suffering dehydration due to acute gastroenteritis. If ondansetron     further reduces the incidence of vomiting compared with intravenous fluid alone, more     children with dehydration due to acute gastroenteritis may be successfully discharged to home     from the emergency department instead of admitted to the hospital. If it does not, the     widespread use of ondansetron for such patients could be discouraged and money could be     saved.      Hypothesis:      Patients receiving ondansetron in addition to intravenous fluids for the treatment of     dehydration due to vomiting caused by gastroenteritis will not have a significant reduction     in the occurrence of persistent vomiting as compared to those who receive only intravenous     fluids.   "
222190|NCT00762788|"     The study is to clinically evaluate currently marketed contact lenses when used in an     extended wear modality of up to seven days/six nights.   "
216984|NCT00691301|"     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving pemetrexed together with cisplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving pemetrexed together with     cisplatin and to see how well it works in treating patients with advanced, persistent, or     recurrent cervical cancer.   "
216985|NCT00691314|"     The purpose of this study is to evaluate the efficacy and safety of stent implantation in     patients with symptomatic extra- and intracranial artery stenosis and to determine its role     in secondary prevention of ischemic stroke.   "
216986|NCT00691327|"     Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women     undergoing primary reconstruction or revision of existing breast implants.   "
216987|NCT00691340|"     Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy     is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the     final end point in blinding diseases of the optic nerve such as glaucoma. It is known that     neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies the     investigators could demonstrate that the process of apoptosis is reflected in circulating     leukocytes by different parameters, like differential mRNA expression and an increased     fragmentation of the DNA. Such alterations point out a relationship between cellular stress     and apoptotic events.      Based on the results of mRNA-expression the investigators also expect alterations on the     protein level.      This study is, therefore, designed to characterize the proteome related to the proteins     involved in cell death related pathways.      Thus, the expression pattern of several proteins in leukocytes from patients with primary     open angle glaucoma will be analyzed by techniques like Western-blot and tandem mass     spectrometry. These samples will be compared with samples from healthy controls. In addition,     they will also be compared with samples from patients with Alzheimer's disease. Since     glaucoma is a neurodegenerative disease, these patients will be included as positive controls     in this study.   "
216988|NCT00691353|"     Cross - Sectional study requiring one visit at the investigators office for the data     collection.        -  Target Group: Patients that suffer from Bipolar Disorder Type 1.        -  YMRS - HAMILTON and GAF scales are going to be used to assess the clinical outcome. The          findings are going to be based on the different scores reported by Specialists (before          the patients started to use as a therapy atypical antipsychotics / at the time that the          visit actually takes place for the cause of the study.) We predefine the time period          that the patient should be using atypical antipsychotics at minimum (2 months).        -  The first 9 consecutive patients that visit the Specialist and meet the entry criteria          and signs the ICF will be recruited in the study.   "
216990|NCT00691379|"     This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus     bevacizumab as first line treatment in patients with metastatic triple negative breast     cancer. Furthermore, the efficacy of the combination therapy will be correlated with the     presence of circulating tumor cells (CTCs) in this population   "
216991|NCT00691392|"     This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in     patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background     Therapy (defined as treatment with > 4 drugs with activity against tuberculosis to which the     patient's isolate is believed to be sensitive by history or based on drug sensitivity     testing).   "
216992|NCT00691405|"     A dose ranging study to evaluate the safety, tolerability and efficacy of arformoterol (given     once or twice a day) in subjects with COPD.   "
216993|NCT00691418|"     This is a feasibility study to determine if it will be possible to conduct a larger study of     the effect of docosahexaenoic acid (DHA), an omega fatty acid, on increased length of     gestation among women who have had a previous preterm delivery.   "
216994|NCT00691431|"     This study compared the clinical outcomes between fellow eyes randomized to either IntraLase     femtosecond laser-created flaps or Hansatome mechanical keratome-created flaps during     wavefront-guided laser in situ keratomileusis.   "
216995|NCT00691444|"     The primary focus of this five-year study will be to optimize the melatonin dosing regimen     for synchronizing the body clocks of blind children to the 24-hour day.   "
216996|NCT00691457|"     Three arm study comparing three novel contact lens solutions.   "
216997|NCT00691470|"     The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The     study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in     the desired therapeutic range. Patients who require chronic anticoagulation with one or more     of the following conditions are eligible for the study: atrial fibrillation or atrial     flutter, prosthetic heart valve, venous thromboembolic disease, or history of myocardial     infarction or cardiomyopathy will be enrolled.   "
216998|NCT00691483|"     The hypothesis is that varenicline will be effective (compared with placebo) for smoking     cessation when subjects are allowed to set their own quit date within the first 5 weeks of     treatment.   "
216999|NCT00691496|"     The purpose of this project is to test the efficacy of an HIV prevention behavioral     intervention to reduce sexual risk among African-American men who have sex with men (MSM).   "
217000|NCT00691509|"     RATIONALE: Eating a diet rich in phytoestrogens may slow the growth of breast cancer cells     and prevent further tumor progression. Learning about the lifestyles of women with breast     cancer, their intake of phytoestrogens derived from food and supplements, and their use of     complementary or alternative medicine (CAM) practices may help doctors learn more about     breast cancer.      PURPOSE: This clinical trial is studying the effect of dietary and supplemental     phytoestrogens and CAM therapies in preventing progression and improving survival of women     with breast cancer.   "
217001|NCT00691522|"     This is a phase II, multicenter, open-label, imaging study of hCRF in the reduction of PBE in     patients with primary malignant or metastatic brain tumors. Approximately 30 to 60 patients     will be assigned to 1 of 3 treatment groups and receive study drug for up to 28 days   "
217002|NCT00691535|"     We hope to learn more about the biology of psychiatric illness with the hope of improving the     diagnosis and treatment of such psychiatric conditions as major depression.   "
217003|NCT00691548|"     Non invasive imaging of cetuximab uptake with PET could help to select the patients who could     be treated by cetuximab, a registered but expensive monoclonal antibody against EGFR. Other     monoclonal antibodies labelled with Zirconium-89 have already been used with success in     patients. The combination of cetuximab labelled with Zirconium-89 is a promising new probe to     determine cetuximab uptake, which has been tested in various pre-clinical animal models in     Maastricht with excellent results.      We propose a two step study design (see figure 1). As our ultimate goal for the future is to     determine the uptake of 89Zr-cetuximab in the tumour before and during therapy, we need to     investigate the toxicity of two consecutive low doses of 89Zr-cetuximab in the first place.     However, as in future studies and in some patients, it is also possible that a single, larger     dose of 89Zr-cetuximab is needed to obtain the best image quality, we will also investigate     the toxicity of a single larger dose.      Step 1: Determination of the toxicity of two low doses of 89Zr-cetuximab In three patients a     standard loading dose of 400 mg/m2 of cetuximab will be administered, partly labelled with     89Zr (60 MBq, 2.5mg) on day 0.      On day 14, a second injection with dose of 250 mg/m2 of cetuximab, partly labelled with 89Zr     (60 MBq, 2.5mg), will be given.      Step 2: Determination of the toxicity of one larger dose of 89Zr-cetuximab A standard loading     dose of 400 mg/m2 of cetuximab will be administered in 3 patients, a part labelled with 89Zr     (120MBq, 5mg).   "
217004|NCT00691561|"     The purpose of this study to conduct a small randomized control trial to compare the relative     effectiveness of a single-session of HIV testing and counseling risk reduction intervention     (HCT-only) to an enhanced intervention that includes the standard HCT intervention plus a     theory-based and culturally-tailored group-level intervention designed to reduce or eliminate     HIV and STI risk behaviors (HCT-plus) among African-American men who have sex with men     (AA-MSM).   "
217005|NCT00691574|"     The goal of this pilot project is to determine whether melatonin levels are disordered in     patients with Smith-Magenis Syndrome (SMS) and whether melatonin treatment can correct     abnormal circadian rhythms in SMS patients. In addition, the study investigates the effects     of bright light in an elderly control population that exhibits low melatonin secretion.   "
217006|NCT00691587|"     Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy     people, but is a significant problem for critically ill or immunocompromised individuals.     Experts estimate that there are greater than 100,000 patients in the United States, Europe     and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently     represent only about 20% of the patients in the hospital who get Pseudomonas infections.   "
217007|NCT00691600|"     The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm     with antibiotic versus non-antibiotic treatment after incision and drainage. We will also     compare successful rates of cure and time to healing with IV antibiotics and 23-hour     observation unit stay versus hospitalization with IV antibiotics for abscesses greater than 5     cm but less than 10 cm in pediatric patients.   "
217008|NCT00691613|"     Rationale:      The investigators hypothesize that EPO protects against apoptosis after acute ischemia in man     and that it is detectable using the annexin-A5 model.      Objective:      Does infusion of a single dose of Epoetin Alfa, a short-acting EPO, protect against apoptosis     in man after acute ischemia?      Study design:      A double blinded randomised cross-over study.      Study population:      12 Healthy male volunteers, between 18 and 40 years old.      Intervention:      All 12 volunteers will receive a single dose of EPO and placebo in a randomized order. A six     week wash-out period is obtained in order to avoid interference of both treatments.      Main study parameters/endpoints:      The percentage of difference between radioactivity (quantified as counts per pixel) of the     experimental and control thenar muscle at one and four hours after reperfusion.   "
217009|NCT00691626|"     The purpose of this study is to compare the effectiveness of two talk therapies for OEF/OIF     Veterans at the Michael J. Crescenz and the West Haven VA Medical Centers. Participants will     randomly receive one of two individual treatments intended to improve the sleep disturbance     and nightmares of returning Veterans.   "
217010|NCT00691639|"     The objective of this study is to obtain blood samples from patients who are or were     participants in any Alcon AL-3789 clinical trial. Association will be conducted to search for     genetic markers in patients with glaucoma or ocular hypertension.   "
217011|NCT00691652|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Giving clofarabine together with rituximab     may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when     given together with rituximab and to see how well they work in treating patients with     relapsed B-cell non-Hodgkin lymphoma.   "
217012|NCT00691665|"     Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis   "
217013|NCT00691678|"     Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint     pain/stiffness associated with aromatase inhibitors.   "
217014|NCT00691691|"     Patients with primary hepato-biliary malignancies or liver metastases from gastrointestinal     cancer suffer substantial morbidity and mortality from their hepatic disease. Curative     resection is feasible only for selected subgroups of patients. The majority of patients have     unresectable and incurable disease. Aggressive arterial and systemic chemotherapy have been     used in recent years with improved response and survival. However, a significant number of     patients, at least one-third of patients with liver metastases from colorectal cancer and     two-third or higher of unresectable hepatobiliary cancer, continue to die of liver failure     from progressive disease in the liver. Percutaneous ethanol injections, chemoembolization,     cryotherapy and thermal ablation using radiofrequency have been used to treat selected     patients with smaller tumors (3-4 cm) in areas away from major blood vessels and the biliary     tract. However, most unresectable liver cancers did not fit the criteria for these     treatments. Therefore, other regional therapeutic option like external radiation therapy may     be considered for local control in the liver or symptom palliation   "
217201|NCT00697242|"     In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B     vaccines with and without MPL will be evaluated in older healthy subjects   "
217015|NCT00691704|"     The purpose of this study is to evaluate the effectiveness of induction therapy with     lenalidomide and low dose dexamethasone followed by sequential low dose bortezomib followed     by low dose Melphalan and Prednisone, then followed by low dose lenalidomide for multiple     cycles in subjects with high risk Multiple Myeloma (MM). The primary objective is to evaluate     the efficacy as measured by the progression free survival (PFS) at 2 years of low dose     sequential therapy following four cycles of induction therapy with lenalidomide/low-dose     dexamethasone in subjects with symptomatic high risk multiple myeloma, who have received no     prior treatment. A total of 35 subjects were estimated to be accrued to this Phase II trial     over a period of subjects who are still progression-free at 2 years. Two years will be as     measured from date of registration to the trial. Progression will include disease progression     (DP) as well as death due to any cause. Data will be analyzed and reported by the PI after 1     and 2 years of initiation of the study. All subsequent data collected may be analyzed and     reported in a follow-up clinical report. The PI and independent reviewers will meet to review     the efficacy and safety data and determine a risk/benefit analysis in this subject     population.   "
217016|NCT00691717|"     The purpose of this study was to evaluate the safety and intraocular-lowering efficacy of     anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the     treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or     ocular hypertension.   "
217017|NCT00691730|"     This research study is looking at kidney and blood pressure changes in patients receiving     bevacizumab, aflibercept, sunitinib, or cediranib for cancer. Studying samples of blood and     urine from patients with cancer in the laboratory may help doctors learn more about changes     that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict     how patients will respond to treatment with an antiangiogenic drug.   "
217018|NCT00691743|"     The current epidemiological study will be undertaken in GP's and specialized private doctors.     In total, 85 general practitioners, orthopedics, rheumatologists and cardiologist will take     part in the study. Data will be collected for 850 patients who visit their physician for     medical conditions that require the use of acetylsalicylic acid and/or NSAIDS. The first 10     consecutive patients who visit their GP/orthopedic/rheumatologist/cardiologists and are     currently receiving acetylsalicylic acid and/or NSAIDS will be included in the study.   "
217019|NCT00691756|"     The purpose of this randomized trial was to determine whether renal perfusion with cold blood     provides better protection against renal ischemia than perfusion with cold crystalloid in     patients undergoing TAAA repair with left heart bypass.   "
217020|NCT00691769|"     The purpose of this research study is to see if a specific protein that we are interested in     is involved in scarring hair loss. If these proteins are involved, further genetic work may     also better define the disease as well as future treatment options.   "
217021|NCT00691782|"     The purpose of this research study is to better understand African American women's hair and     hair styling practices and how these practices affect attitudes and viewpoints regarding     exercise.   "
217022|NCT00691795|"     Epidural analgesia is widely regarding as the most effective analgesic strategy for labor     pain. Modern practice is to utilize dilute local anesthetics as a continuous infusion along     with an opioid, e.g., our common recipe of 12 ml/hr of 0.0625% bupivacaine with 2     micrograms/ml fentanyl, after the initial dose to maintain patient comfort until delivery.     This dose of the infusion often provides adequate comfort without interfering with the     mobility of the patient and her ability to effectively push during delivery. However, this     low dose epidural infusion strategy often results in recurrence of pain after an initial pain     free period.      This breakthrough pain is treated by administering small boluses of analgesics via the     epidural catheter. The pain occurring in labor is initially of visceral origin and is     mediated by pain fibers originating from the low thoracic and upper lumbar segments of the     spinal cord. As labor progresses to the late first phase (also known as transitional stage),     pain sensations originating from the distension of the pelvic floor, vagina and perineum adds     a somatic component to labor pain. This type of breakthrough pain is often difficult to     treat.      Although requests from patients to alleviate late stage breakthrough pain are common, no one     knows the most effective strategy for pain management in this stage of labor. This study is     designed to compare the efficacy of two treatments for controlling late first stage     breakthrough pain during labor with an epidural infusion in place: clonidine-bupivacaine     versus fentanyl-bupivacaine.      Women who have labor epidural analgesia in place will be enrolled to be randomized if and     when they present with breakthrough pain in the late first stage or second stage of labor (≥     8 cm dilated). They will receive 8 ml of a solution containing 10 mg bupivacaine and 75     micrograms of either fentanyl (an opioid or narcotic) or clonidine (an alpha-2 agonist     known to be effective as an epidural analgesic).      Pain relief, labor progress and outcome will be assessed to compare fentanyl versus     clonidine.      It is the hypothesis of this study that clonidine added to bupivacaine is a better analgesic     than fentanyl added to bupivacaine for breakthrough pain in advanced labor.   "
217023|NCT00691808|"     The purpose of the study is to determine the safety, tolerability, and effectiveness of 2     dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment     (AAMI).   "
217024|NCT00691821|"     The purpose of this study is to assess the difference in the percent reduction in wound     surface area, without surgery, of chronic pressure ulcers of the pelvic region for Negative     Pressure Wound Therapy (NPWT) compared to the standard dressing. This study is designed to     provide evidence regarding NPWT as compared to standard dressing regimens and compare the     efficacy, safety, effectiveness and cost-effectiveness.   "
217025|NCT00691834|"     The purpose of this study is to test bone marrow mononuclear cells for patients with recent     heart attack who are at high risk of experiencing heart failure. This study drug is made of     you own cells. Studies similar to this one have suggested that the use of cell-based transfer     after heart attack can improve the recuperation of the heart. The purpose of this study is to     assess whether cell transfer can improve the healing of the heart after a heart attack.   "
217026|NCT00691847|"     Determine if edema plays a role in refractive surgery   "
217027|NCT00691860|"     Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the     lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce     parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position.     Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In     the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study     group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the     mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity   "
217028|NCT00691873|"     In patients with at least moderate persistent allergic asthma controlled with inhaled     steroids, omalizumab (administered per US product label), when compared to placebo, will     provide the participants with significantly improved tolerability of specific allergen     immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).   "
217031|NCT00691912|"     Today metastatic breast cancer is regarded as cureless. The treatment is palliative in intent     and the goals of treatment include improvement of quality of life and if possible     prolongation of life. Treatment in metastatic cancer will usually involve hormone therapy     and/or chemotherapy. Weekly application of chemotherapeutical drugs may lead to less drug     concentrations in healthy tissue and therefore toxicities maý be reduced.   "
217032|NCT00691925|"     Using Contact lens following refractive procedure to reduce pain.   "
217033|NCT00691938|"     This study is designed to evaluate the combination of LBH589 and decitabine in patients age ≥     60 years with high risk Myelodysplastic Syndrome (IPSS Int-2 or High) or Acute Myeloid     Leukemia.   "
217034|NCT00691951|"     A reduced response to inhaled corticosteroids (ICS) has been reported in smoking compared to     non-smoking asthmatic patients. However, the comparative response to other currently     prescribed medications such as combination therapy of long-acting beta agonists and ICS     remain to be further evaluated.      No significant differences were found between our group of subjects in regard to changes in     asthma control pulmonary function and airway inflammation following budesonide or the     association of budesonide with formoterol for a period of 2 months. This should be further     explored in larger groups of subjects.   "
217035|NCT00691964|"     Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque     psoriasis   "
217036|NCT00691977|"     The purpose of the study is to assess the safety of four different doses of radiation therapy     followed by to surgery to remove prostate tumor.   "
217037|NCT00691990|"     Protocol Synopsis        -  Design: Prospective, single-center randomized study Patient Population: Male or female          subjects 18 years of age or older who are scheduled for total thyroidectomy        -  No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to          enroll        -  Duration of Treatment: During the operation        -  Duration of Follow-up: Follow-up will be performed daily while hospitalized, and by          phone till the 7th postoperative day        -  Endpoints: To evaluate the safety and cost-effectiveness of each technique   "
217038|NCT00692003|"     Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study     is intended to provide evidence that zonisamide is safe and effective in the treatment of     primary generalised tonic-clonic seizures. The total trial duration will be 5.5-6.5 months.     After that subjects who have completed the study will be eligible to enrol in an open-label     extension study until zonisamide is marketed for this indication or further development in     this indication stops. This extension study will be described in a separate protocol     (E2090-E044-316).   "
217039|NCT00692016|"     The purpose of this study is to provide information on how well an extended release     formulation (a medication that is released and absorbed over a longer period of time than a     regular release formulation of the medication) of naproxen sodium is absorbed into the     bloodstream after eating a high calorie breakfast and also after fasting (not eating for 14     hours).   "
217040|NCT00692029|"     To assess the relationship between pre-teen/teen height, age, weight, gender, and body     proportions and shape and size of youth and comfort and safety when operating adult All     Terrain Vehicles (ATV).   "
217041|NCT00684957|"     The purpose of this study is to see if giving growth hormone or insulin-like growth factor-1     (IGF-1) to subjects with growth hormone deficiency effects cardiovascular risk factors     differently.   "
217042|NCT00684970|"     Hamsa-1™ is an anti-angiogenic drug combination designed for the treatment of cancer. The     investigational product Hamsa-1™ comprises of four well-known active components. The therapy     is administrated at a unique dosing regimen that was found to be effective and advantageous     in terms of safety.The product is formulated as an oral suspension, conveniently     administrated by the patients at home and not requiring medical staff assistance. This Phase     IIb clinical trial aims to evaluate the efficacy of Hamsa-1™ for the treatment of metastatic     Castration Resistant Prostate Cancer (CRPC) patients.   "
217043|NCT00684983|"     This randomized phase II trial studies capecitabine and lapatinib ditosylate to see how well     they work compared with capecitabine, lapatinib ditosylate, and cixutumumab in treating     patients with previously treated human epidermal growth factor receptor 2 (HER2)-positive     stage IIIB-IV breast cancer. Drugs used in chemotherapy, such as capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Lapatinib ditosylate may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as cixutumumab, can block the ability of tumor cells to grow and spread. It     is not yet known whether capecitabine and lapatinib ditosylate are more effective when given     with or without cixutumumab in treating breast cancer that has spread nearby or to other     areas of the body.   "
217044|NCT00684996|"     This phase I/randomized phase II trial is studying the side effects and best dose of     bevacizumab and to see how well it works when given together with or without MEDI-522 in     treating patients with unresectable or metastatic kidney cancer. Monoclonal antibodies, such     as bevacizumab and MEDI-522, can block tumor growth in different ways. Some block the ability     of tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Bevacizumab and MEDI-522 may also stop the growth of tumor     cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more     effective when given together with or without MEDI-522 in treating kidney cancer.   "
217045|NCT00685009|"     Excessive memory decline or dementia affects an increasing number of women as they become     older. The frequency of dementia doubles every 5 years beginning at age 60, making the     discovery of ways to prevent or slow the disease imperative. Previous studies have indicated     that changes in memory may be associated with the female hormonal decline that occurs after     menopause, but more research is needed to establish the link between menopause and poorer     memory function. It is believed that taking the female hormones estrogen and/or progesterone     may help improve women's health by protecting against memory decline. This study will     evaluate the effects of female hormone replacement therapy (HRT) on the development and     progression of memory loss in older women enrolled in the Women's Health Initiative (WHI)     study.   "
217046|NCT00685022|"     The purpose of this study is to compare the safety and tolerability of levalbuterol HFA     metered dose inhaler (MDI) versus racemic albuterol HFA MDI.   "
217047|NCT00685035|"     Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher     inflation pressures combined with both low and high oscillator frequencies will result in     greater sputum production compared to sine waveform HFCWO with lower inflation pressures and     mid-frequency oscillations.   "
217048|NCT00685048|"     This project evaluates the efficacy of brief interventions for individuals seeking treatment     for substance use disorders who also have gambling problems. In total, 220 problem gambling     substance abusers will be randomized to one of three conditions: (a) a control condition     consisting of 10 minutes of psychoeducation about gambling, (b) 10 minutes of brief advice     about problem gambling and how to reduce it, or (c) four session of motivational and     cognitive-behavioral therapy. Gambling, substance use and psychosocial problems will be     assessed using standardized instruments at pre-treatment, month 2, 5, 8, 12, 16, 20 and     24-month follow-up evaluations.   "
217049|NCT00685061|"     To compare in a randomized prospective study the effectiveness and toxicity of Thymoglobulin     vs. Campath-1H used for induction therapy vs. our conventional therapy in recipients of first     cadaver (CAD) kidneys.   "
217050|NCT00685074|"     The purpose of the study is to see if a brief computer program can help new mothers cut down     or quit tobacco, alcohol, or drug use.   "
217051|NCT00685087|"     To prospectively define the natural history and the clinical, laboratory and     histomorphometric features of chronic pancreatitis (CP) of varying etiology. To identify     clinical and laboratory parameters that correlate with the pathophysiologic state in patients     with CP. To quantify the behavioral abnormalities associated with CP. To determine     psychological and behavioral correlates of CP disease progression and outcomes.   "
217052|NCT00685100|"     Background: To identify characteristic morphological changes of the retina, their change over     time and the association with visual function after combined photodynamic therapy (PDT) and     intravitreal triamcinolone (IVTA).      Methods: In this retrospective study, 40 patients (40 eyes) were treated with PDT and same     day IVTA. Optical coherence tomography (OCT), fluorescein angiography (FA) and evaluation of     distance visual acuity (VA) were performed. Main outcome measures were the anatomical changes     within intra- and subretinal compartments and their detailed analysis and grading.   "
217127|NCT00692120|"     Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been     assumed that these two forms maintain blood vitamin D equally. However, this may not be the     case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D.     Additionally, it will evaluate whether once per month vitamin D dosing is as effective in     maintaining blood vitamin D levels as daily dosing.   "
217053|NCT00685113|"     This is a multicenter study to evaluate the efficacy and safety of 2 different doses of     DR-3001. For eligible subjects the duration of the study will be approximately 20 weeks; this     will consist of a 4-week screening period, a 12-week treatment period and a 4-week follow-up     period. Subjects will have physical and laboratory exams, including blood draws at each     scheduled visit. Subjects will be required to insert a vaginal ring (replacing it every 4     weeks) and to keep a daily record of their toilet voids (including time,type and volume) for     3 days at several specified time points.   "
217054|NCT00685126|"     The purpose of this study is to compare the efficacy of two dose levels of levalbuterol     compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48     months old.   "
217055|NCT00685139|"     The purpose of this study is to evaluate and compare the relative bioavailability of a test     formulation of zonisamide capsules to an equivalent dose of a reference formulation,     Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting     conditions.   "
217056|NCT00685152|"     This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and     safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for     6 weeks. The primary objective is to evaluate the change in PTSD symptoms before and after     six weeks of high-frequency rTMS treatment as measured by the Clinician Administered PTSD     Scale (CAPS) in both active and control groups.   "
217057|NCT00685165|"     The purpose of this study is to compare the bioequivalence of a test formulation of primidone     tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets)     in adult subjects under fasting conditions.   "
217058|NCT00685178|"     This is an outpatient clinical trial of topiramate for addressing cocaine dependence and     reduction of cocaine associated behaviors in opiate dependent drug users maintained on     methadone treatment.      The study aims to answer whether topiramate        1. is safe and acceptable to methadone patients        2. reduces cocaine use        3. helps with collateral problems such as alcohol abuse, tobacco dependence, anxiety, PTSD          and/or pain symptoms. The study will also evaluate topiramate effect on neuro-cognitive          performance.   "
217059|NCT00685191|"     The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating     raltegravir-based salvage therapy and quantify the corresponding changes in levels of     cellular HIV-1 DNA.   "
217060|NCT00685204|"     Milataxel is a new taxane that may have several advantages over the currently available     taxanes. The current study is designed to determine the response rate of oral Milataxel in     patients with malignant Mesothelioma. The study specifically targets patients who have     recurring or progressive disease following previous chemotherapy.   "
217061|NCT00685217|"     This randomized multi-centre trial will recruit women with stress urinary incontinence who     need surgical treatment for their condition. 300 women will be allocated either to receive a     TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the     procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after     surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists,     urologists and general obstetrician-gynaecologists: all clinicians will have received     adequate training.   "
217087|NCT00685555|"     The purpose of this research is to increase community awareness about the relationship     between physical activity, screen time, and nutrition and how these factors influence healthy     weight management.      The problem of obesity is at epidemic proportions and has become the most important public     health problem confronting the United States today. Of greatest concern is the 300% increase     in obesity rates among children and youth over the past twenty years. Childhood obesity is a     precursor of adult obesity.   "
217062|NCT00685230|"     There is no FDA approved therapy for the treatment of scorpion envenomation, Centruroides     scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging     from trivial to life threatening. Patients stung by Centruroides scorpions develop a clinical     syndrome which may require sedation with benzodiazepines and observation for 6 to 28 hours of     intensive care monitoring. A safe therapy is necessary to halt the progression of symptoms     early in the clinical course while avoiding the clinical deterioration that can occur en     route to a tertiary facility. Alacramyn® is anticipated to be safer and more effective than     the present standard of care, midazolam, and faster-acting such that the need for transport     of most rural patients will be eliminated and will reduce hospitalization time.      The working hypotheses are as follows:        1. The investigational antivenom is safe as treatment of scorpion sting envenomation.        2. The investigational antivenom is effective as treatment of scorpion sting envenomation.   "
217063|NCT00685243|"     1. Evaluate the efficacy of the Fraxel SR laser to improve the cosmetic appearance of          surgical scars, both in terms of pigmentary and textural changes.        2. Evaluate the efficacy of the V-Beam Pulse Dye laser, a standard non-ablative laser which          is utilized for the treatment of the erythematous and telangiectasia component of          surgical scars.        3. Comparison of the outcome of the half of the surgical scar treated with Fraxel SR laser          versus the outcome of the contralateral half of the surgical scar which will be treated          with the V-Beam Pulse Dye Laser.   "
217064|NCT00685256|"     RATIONALE: A study that evaluates the support of a decision guide used together with genetic     counseling may improve communication between mothers undergoing BRCA1/2 testing and their     minor-age children.      PURPOSE: This randomized phase III trial is studying standard genetic counseling given     together with a decision guide to see how well it works compared with genetic counseling     alone in improving communication between mothers undergoing BRCA1/2 testing and their     minor-age children.   "
217065|NCT00685269|"     The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with     mild to moderate OSAS.   "
217066|NCT00685282|"     The general hypothesis of the research is that stress decreases fertility and that Cognitive     Behavioral Therapy will reduce stress and increase fertility. Secondarily, we hypothesize     that stress has a detrimental effect on DNA integrity and that stress reduction will reduce     DNA damage in the cell.   "
217067|NCT00685295|"     Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does     the comparator Percocet   "
217068|NCT00685308|"     This is a prospective, multi-center, non-randomized trial to study one-year outcomes of the     Wingspan system for the treatment of Chinese patients with symptomatic atherosclerotic severe     intracranial stenosis.   "
217128|NCT00692133|"     Non-interventional, prospective study to validate Spanish version of TOOL questionnaire in     patients with schizophrenia and bipolar disorder under antipsychotic treatment   "
217129|NCT00692146|"     A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate     the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms     and heat sensitivity in healthy volunteers   "
217069|NCT00685321|"     Objectives:The purpose of the study is to explore the efficacy and safety of H1-Coil deep     brain rTMS in subjects with negative symptoms and cognitive deficits of schizophrenia     (deficit syndrome), currently treated with atypical antipsychotics.      Patient Population: The intention is to treat 45 patients diagnosed with schizophrenia, who     are currently suffering mainly from negative symptoms and cognitive deficits (deficit     syndrome). The patients will be of all racial, ethnic and gender categories, ranging from 18     to 65 years of age, and have PANSS negative≥21 and PANSS positive<24. Patients will be     recruited from both academic and private research centers.      Structure: The study is a randomized, prospective, 8 weeks, double blind study. Blinding: The     treatment administrator and the study personnel and patients will be masked to the treatment     being administrated.      Concurrent Control: The study group will receive active rTMS treatment and the control group     will receive an inactive, sham treatment.   "
217070|NCT00685334|"     This study will compare the effectiveness of two atypical antipsychotic medications,     olanzapine and aripiprazole, in treating people with anorexia nervosa.   "
217071|NCT00685347|"     The purpose of this study is to investigate, using an exercise challenge approach, the dose     response of levalbuterol HFA MDI in pediatric subjects with asthma   "
217072|NCT00685360|"     This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of     multidrug resistant tuberculosis (MDR TB) for 56 days. In addition to an optimized background     regimen (OBR).patients will receive will be randomized to:        -  100 mg OPC-67683 BID        -  200 mg OPC-67683 BID        -  placebo BID After 56 days subjects will complete their OBR.   "
217073|NCT00685373|"     This will provided long-term safety and efficacy data for ACZ885 (a fully human     anti-interleukin-1β [anti-IL-1β] monoclonal antibody) given as an injection subcutaneously in     patients who participated in the CACZ885A2102 (NCT00487708), CACZ885D2201 (NCT00685373) or     CACZ885D2304(NCT00465985) studies or newly identified patients with the following     cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome,     Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease.      The duration of this study was 6 months with a maximum duration of 2 years   "
217074|NCT00685386|"     The purpose of this study it to conduct a randomized, controlled, double-blinded trial of     carbon dioxide (CO2) versus air insufflation during endoscopic retrograde     cholangiopancreatography (ERCP).   "
217075|NCT00685399|"     This study was performed to evaluate the efficacy and safety of AIN457 for patients with     active uveitis that requires systemic immunosuppression.   "
217088|NCT00685568|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of celecoxib may keep polyps and colorectal cancer from forming in patients with familial     adenomatous polyposis.      PURPOSE: This randomized phase I trial is studying the side effects and best dose of     celecoxib in treating young patients with a genetic predisposition for familial adenomatous     polyposis.   "
217089|NCT00685581|"     The investigators' project has for principal objective to evaluate the impact of three     specific ruminant milk fats with a Trans Fatty Acid content ranging from 2.9% to 12.2%     obtained by modification of the cow's diet on cardiovascular risk factors in healthy     subjects.   "
217076|NCT00685412|"     DNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages     over traditional vaccines such as live attenuated virus and recombinant protein-based     vaccines. DNA vaccines appear to be well tolerated in humans. Therefore, we have developed     our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of both HPV     subtypes 16 and 18. We have chosen to deliver our candidate vaccines via electroporation (EP)     using the CELLECTRA™ constant current device to deliver a small electric charge following     intramuscular (IM) injection, since animal studies have shown that this delivery method     increases the immune response to our DNA vaccine leading to a decrease in the size of tumors     caused by HPV 16 and 18. The vaccine is proposed to be given to patients with a history of     CIN 2 and 3 that have been treated by surgery. We will determine which dose the DNA vaccine     will be the best tolerated and elicit the strongest immune response.   "
217077|NCT00685425|"     The purpose of this study is to investigate, using an exercise challenge approach, the dose     response of levalbuterol HFA MDI in adolescent and adult subjects with asthma   "
217078|NCT00685438|"     With the increasing tourism and adventure travel into extreme environments comes the need to     reassess the required protection against ultraviolet (UV) radiation and possible other     oxidative stresses. This is an observational study of UV radiation exposure and skin erythema     while at extreme altitude (Mt. Everest). In addition to UV exposure, skin erythema,     antioxidant use (such as vitamins C and E) will be measured.      Hypothesis:        1. UV radiation at extreme altitude has larger effects on the skin than at sea level;          therefore requiring an adjustment of the antioxidant use for adequate protection.        2. The skin is an accurate reflection of UV and oxidative stress exposure        3. The efficacy of oxidatives stress is reflective of the ethnicity of the individual.   "
217079|NCT00685451|"     The purpose of this phase of the study is to assess the feasibility of a cognitive behavioral     therapy for post-traumatic stress disorder (PTSD) in persons receiving outpatient services at     an addiction treatment program. The next phase of the study will be a more rigorous     investigation of the efficacy of the PTSD therapy within addiction treatment settings.   "
217080|NCT00685464|"     The aim of this study is to investigate wether intracoronary use of bolus Abciximab is     superior to intravenous bolus in patients undergoing percutaneous coronary intervention.   "
217081|NCT00685477|"     This is a clinical research study to establish normal values for the infusion of a synthetic     form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is     released from the small bowel to stimulate the pancreas and gallbladder to help digest and     absorb food. Some people have gallbladder problems and need to be tested with the synthetic     cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out     how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying.     The findings in normal subjects will be used to establish normal values that can then be     compared with patients with suspected gallbladder disease.   "
217082|NCT00685490|"     To evaluate the long term outcomes of pars plana vitrectomy (PPV), with and without internal     limiting membrane (ILM) peeling, in eyes with persistent macular edema secondary to branch     retinal vein occlusion (BRVO).      Results suggest the following hypothesis:        -  PPV, with and without ILM peeling, appears to be beneficial in eyes with persistent          macular edema due to BRVO        -  Effectiveness is maintained long term        -  ILM peeling does not significantly affect postoperative best corrected visual acuity          (BCVA)   "
217130|NCT00692159|"     This study is being performed to evaluate the safety and tolerability of TRC102 in     combination with Alimta. In addition to safety, this study will also evaluate     pharmacokinetics and tumor response.   "
217131|NCT00692172|"     An extension study to evaluate safety and tolerability of up to 3 additional courses of IM     alefacept in patients with chronic plaque psoriasis who have been previously treated with 1     or 2 courses of IM alefacept.   "
217083|NCT00685503|"     This study will examine whether the drug ranibizumab (Lucentis) can help prevent vision loss     in people with macular telangiectasia, a condition in which new blood vessels grow in the     retina at the back of the eye and can leak. Such changes in blood vessels are seen in other     diseases associated with changes in a body chemical called vascular endothelial growth factor     (VEGF). Ranibizumab is an anti-VEGF drug that is effective in treating another eye disease,     age-related macular degeneration, with similar changes in eye blood vessels.      People 18 years of age and older with macular telangiectasia in both eyes and new blood     vessel growth in at least one eye may be eligible for this study. They must have vision     better than 20/400 in the study eye.      Participants undergo the following procedures:        -  Ranibizumab injections in the study eye at least four times over 12 weeks. Depending on          the response to treatment and the side effects, additional injections may be given every          4 weeks for up to 1 year. The eye is numbed before the injection and the eye area is          cleaned with an antiseptic. Antibiotic drops are used for 3 days following the injection          to prevent infection.        -  Evaluations before starting treatment, at the time of each injection, and 8 weeks after          the last treatment:             -  History and physical examination.             -  Eye examination with dilation, microperimetry and photography: The eye examination               measures visual acuity, eye pressure and eye movements. For the microperimetry               test, subjects sit in front of a computer screen and press a button when they see a               light on the screen. Measurements and photographs of the retina are also taken.             -  Fluorescein and indocyanine green angiography to examine the blood vessels in the               eye: A dye called fluorescein or indocyanine green is injected into a vein in the               arm. The dye travels through the veins to the blood vessels in the eyes. A camera               takes pictures of the dye as it flows through the blood vessels.             -  Pregnancy test: Women who are able to become pregnant have a urine pregnancy test               before each ranibizumab injection.   "
217084|NCT00685516|"     RATIONALE: Green tea contains ingredients that may prevent or slow the growth of certain     cancers. It is not yet known whether green tea is more effective than black tea or water in     treating prostate cancer.      PURPOSE: This randomized phase II trial is studying green tea to see how well it works     compared with black tea and water in treating patients with prostate cancer undergoing     surgery.   "
217085|NCT00685529|"     The purpose of this study is to compare the blood levels of arformoterol tartrate inhalation     solution to racemic formoterol in male and female subjects with mild to moderate Chronic     Obstructive Pulmonary Disease (COPD).   "
217086|NCT00685542|"     Ostearthritis is one of the most common arthritis, affecting more than 30% of aged people     world-widely. The disease is characterized by pain and stiffness of the affected joints and     is the most common cause of disability in aged people. It commonly affects knee, hip, hand     and spine joints. Diacerein is a drug developed specifically for the treatment of     osteoarthritis. It has inhibitory effects on interleukin-1 (IL-1) and metalloproteases which     are known to play key roles in the pathogenesis of osteoarthritis while exerting no effect on     phospholipase A2, cyclooxygenase or lipoxygenase. It showed anti-inflammatory effects on     animal models and reduced structural changes in several animal models. Therefore, we     investigate the role of diacerein in patients with hand osteoarthritis.   "
217090|NCT00685594|"     The prevalence of type 2 diabetes is increasing, which for most societies has considerable     consequences not only regarding health but also economy. Type 2 diabetes develops through a     prediabetic stage with impaired glucose tolerance. Intervention at this stage with change     in lifestyle or with medication may prevent such progression. There are indications that     vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may     increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with     vitamin D may improve glucose tolerance and potentially prevent the development of type 2     diabetes in subjects at risk. However, this has so far not been demonstrated in a     prospective, randomised clinical study. In the present study we will therefore include 600     subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso     study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo     for 5 years. A glucose tolerance test will be performed each year, and development of type 2     diabetes will be the main endpoint.   "
217091|NCT00685607|"     For six hours following drug administration, subjects will rate the severity of specific     symptoms. At the end of the six hour study, subjects will rate the overall effectiveness of     the product.   "
217092|NCT00685620|"     Purpose of the project is to examine the effectiveness of Reinforcement-Based Treatment (RBT)     on drug abuse and psychosocial outcomes of iner city opiate abusers who have recently     completed a brief detoxification.   "
217093|NCT00685633|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such     as bicalutamide, may lessen the amount of androgens made by the body. Enzastaurin may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not     yet known whether giving bicalutamide together with enzastaurin is more effective than     bicalutamide alone in treating prostate cancer.      PURPOSE: This randomized phase II trial is studying bicalutamide to see how well it works     compared with giving bicalutamide together with enzastaurin in treating patients with     prostate cancer.   "
217094|NCT00685646|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen blockade therapy     may lessen the amount of androgens made by the body. Zoledronic acid may help relieve some of     the symptoms caused by bone metastasis. It is not yet known whether androgen-blockade therapy     is more effective with or without zoledronic acid in treating patients with prostate cancer     that has spread to the bone.      PURPOSE: This randomized phase III trial is studying androgen-blockade therapy given together     with zoledronic acid to see how well it works compared with androgen-blockade therapy alone     in treating patients with prostate cancer and bone metastases.   "
217132|NCT00692185|"     This study will evaluate the effectiveness of the antipsychotic medication olanzapine in     treating outpatients with anorexia nervosa.   "
217095|NCT00685659|"     This study tests the effectiveness of two 24 month, telephone-based adaptive continuing care     interventions for patients with cocaine dependence. The two interventions are predicted to     produce better drug use outcomes than standard care. Furthermore, the intervention that also     includes monetary incentives for continued participation is hypothesized to produce better     retention and drug use outcomes than the intervention without incentives. Economic analyses     will determine the cost-effectiveness and benefit-cost of the interventions relative to     standard care, and to each other.   "
217096|NCT00685672|"     Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural     solution given to women in childbirth   "
217097|NCT00685685|"     The purpose of this study is to evaluate and compare the relative bioavailability and     therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent     dose of Mevacor® tablets after a single oral dose administered under fasting conditions.   "
217098|NCT00685698|"     Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections   "
217099|NCT00685711|"     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with     allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived     peptide desensitising vaccine, currently being developed for the treatment of cat allergy.     This study will investigate the safety of Cat-PAD administered as increasing single doses.   "
217100|NCT00685724|"     Pathological gambling is serious problem, with significant psychological, financial, and     public health consequences. Nevertheless, controlled trials examining the efficacy of     therapeutic interventions for pathological gamblers are sparse, and many pathological     gamblers recover on their own, or with only minimal interventions. In this initial study of a     SMART design for pathological gamblers, we will offer a brief intervention to all (n = 100),     and subsequently randomize individuals based upon their initial treatment response to varying     intensities of additional care from none to 8 sessions of individual cognitive behavioral     therapy (CBT) plus 14 weeks of Aftercare. Gambling outcomes will be assessed pre-treatment     and at about weeks 10, 24, 36 and 52.   "
217101|NCT00685737|"     The Purpose of this study is to determine the safety and tolerability of 1-MNA, a drug that     is intended to be used in the treatment of elevated levels of blood fats. This study will     determine the way that 1-MNA is handled by the body, and will also determine its effect on     commonly measured blood fat parameters.   "
217102|NCT00685750|"     This study intends to analyze the expression of specific sets of markers in tumor samples and     in serum from patients with Non-Small Cell lung Cancer (NSCLC) or Stage III or IV melanoma.     The data obtained in this study will be used to guide future development of immunotherapies     for melanoma or NSCLC patients. Moreover, the analyses will contribute to definition of     markers potentially predictive of clinical response to specific anticancer therapies.   "
217103|NCT00685763|"     The purpose of this study is to find out what effects, good and/or bad, proton radiation and     chemotherapy has on you and your pancreatic cancer.   "
217104|NCT00685776|"     This study will evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to     placebo, on plasma concentrations of Low Density Lipoprotein Cholesterol and assess the     safety and tolerability of anacetrapib (100 mg) in participants with CHD/CHD risk-equivalent     disease on stable dose regimen of statin with or without other lipid-modifying therapy. The     two year extension to this study will further evaluate the long-term safety profile and     efficacy of anacetrapib in CHD/CHD-risk equivalent patients who are on ongoing therapy with a     statin with or without other lipid-modifying therapy.   "
217106|NCT00685802|"     The purpose of this study is to evaluate and compare the relative bioavailability of a test     formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after     a single oral dose administered under fasting conditions.   "
217107|NCT00685815|"     To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS)     symptoms and brain concentrations of iron.   "
217108|NCT00685828|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. It is not yet known which dose of imatinib mesylate is more     effective in treating gastrointestinal stromal tumor.      PURPOSE: This randomized phase III trial is studying two different doses of imatinib mesylate     to compare how well they work in treating patients with unresectable or metastatic     gastrointestinal stromal tumor.   "
217109|NCT00685841|"     A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily     compared to placebo in subjects with COPD.   "
217110|NCT00685854|"     This study will examine whether the drug ranibizumab (Lucentis) can help prevent vision loss     in people with macular telangiectasia, a condition in which new blood vessels grow in the     retina at the back of the eye and can leak. Such changes in blood vessels are seen in other     diseases associated with changes in a body chemical called vascular endothelial growth factor     (VEGF). Ranibizumab is an anti-VEGF drug that is effective in treating another eye disease,     age-related macular degeneration, with similar changes in eye blood vessels.      People 18 years of age and older with macular telangiectasia in both eyes with no new blood     vessel growth in either eye may be eligible for this study. They must have vision better than     20/400 in the study eye.      Participants undergo the following procedures:        -  Ranibizumab injections in the study eye at least four times over 12 weeks. Depending on          the response to treatment and the side effects, additional injections may be given every          4 weeks for up to 1 year. The eye is numbed before the injection and the eye area is          cleaned with an antiseptic. Antibiotic drops are used for 3 days following the injection          to prevent infection.        -  Evaluations before starting treatment, at the time of each injection, and 8 weeks after          the last treatment:             -  History and physical examination.             -  Eye examination with dilation, microperimetry and photography: The eye examination               measures visual acuity, eye pressure and eye movements. For the microperimetry               test, subjects sit in front of a computer screen and press a button when they see a               light on the screen. Measurements and photographs of the retina are also taken.             -  Fluorescein and indocyanine green angiography to examine the blood vessels in the               eye: A dye called fluorescein or indocyanine green is injected into a vein in the               arm. The dye travels through the veins to the blood vessels in the eyes. A camera               takes pictures of the dye as it flows through the blood vessels.             -  Pregnancy test: Women who are able to become pregnant have a urine pregnancy test               before each ranibizumab injection.   "
217148|NCT00696540|"     We will study if small children who become ill with respiratory distress during the RSV     epidemic are better relieved with salbutamol nebulizations diluted in hypertonic (3%),     instead of normal (0.9%) saline.   "
217149|NCT00696553|"     To test the effects of nutrition versus nutrition with resistance exercise on muscle mass     loss, fatigue and outcomes of concurrent chemo radiation.   "
217111|NCT00685867|"     The study is a two-arm controlled multi-centre trial of two strategies to reduce nosocomial     MRSA transmission and infection among surgical patients. Enrolment and primary analyses will     be performed at the hospital level. A total of ten adult surgical departments with at least 3     surgical subspecialties each will participate in the study. Sites of the study are located in     9 countries (UK, France, Spain, Germany, Switzerland, Italy, Serbia, Greece and Israel).      The primary objective is to determine the effect of an early MRSA detection & decolonization     & isolation strategy compared to an enhanced standard control strategy on     healthcare-associated MRSA isolation rates among surgical patients at risk of MRSA carriage,     who are hospitalized for at least 24 hours.   "
217112|NCT00685880|"     Arthritis of the base of the thumb is a common debilitating problem. It is believed that     laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be     treated by securing the joint surgically or symptoms can be treated with hand therapy and/or     injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease     looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that     prolotherapy injections for thumb arthritis will be equally or more beneficial to the     patients than steroids.   "
217113|NCT00685893|"     The purpose of this research study is to evaluate an intervention to improve the care given     to patients who are dying in the intensive care unit (ICU) and their families. This study is     a multi-center randomized trial of a multi-faceted quality improvement intervention designed     to improve the quality of palliative and end-of-life care in the ICU setting. The     intervention targets the hospital and the outcome evaluation occurs at the level of the     individual patient and family with surveys completed by family members and nurses as well as     standardized medical record review.   "
217114|NCT00685906|"     The purpose of this study is to examine the effect of co-administration of AZD6140 and     Nordette® on the blood levels of certain female hormones.   "
217115|NCT00685919|"     The purpose of the proposed research is to determine how changes in kidney dopamine (DA)     activity influence urinary sodium excretion. We will decrease DA activity in the kidney by     inhibiting DA synthesis via carbidopa administration. We want to compare findings in normal     volunteers and in patients with postural tachycardia syndrome (POTS). We will test the null     hypothesis (Ho) that the effects of oral carbidopa administration on urinary sodium excretion     will not differ between patients with POTS and healthy volunteers.   "
217116|NCT00685932|"     The purpose of this study is to investigate whether the use of the Mobius® retractor     decreased post-operative pain after cesarean section verses conventional retractor use. Based     on clinical experience and a pilot study, we suspect that the retractor will decrease overall     pain as well as lateral pain.   "
217117|NCT00685945|"     The purpose of the study is to determine if giving isosorbide,a drug that is used to treat     chest pain, affects blood vessel release of an anti-clotting factor.   "
217118|NCT00685958|"     The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous     blood clots in patients with hip fracture surgery.   "
217119|NCT00685971|"     The main aim of the research question to test the primary hypothesis of this study, namely,     Does 12 weeks of an additional 5000 IU daily of cholecalciferol increase serum 25OHD levels     in adults with Cystic Fibrosis (CF) who have vitamin D deficiency relative to placebo?   "
217120|NCT00685984|"     Silent myocardial ischemia is usual in type 2 diabetic patients and associated with coronary     stenoses and endothelial dysfunction or both. We therefore hypothesized that peripheral     endothelial dysfunction is a marker of silent myocardial ischemia. The aim of the study is,     in 120 asymptomatic type 2 diabetic patients, to evaluate the relations between coronary     status, assessed with myocardial scintigraphy and subsequent coronary angiography in case of     abnormality, and peripheral endothelial function, according to post-occlusive hyperaemia     endothelium-dependent brachial artery dilation.   "
217123|NCT00692068|"     Residual renal function is reported to contribute to the survival and cardiovascular disease     of peritoneal dialysis patients. Oxidative and carbonyl stress are increased in peritoneal     dialysis patients and are associated with cardiovascular risk. The aim of this study was to     determine the relations between residual renal function and oxidative and carbonyl stress in     peritoneal dialysis patients.   "
217124|NCT00692081|"     Emotional and behavioural problems as well as a lack of social competence are supposed to be     common phenomena in adolescents with borderline intellectual functioning, consequently     impairing their social and vocational integration. Considering the lack of evaluated group     interventions for this population, a cognitive-behavioural training is developed and its     effectiveness is examined in a population of students attending special vocational schools.      77 adolescents with borderline intelligence are enrolled participated in the study. They are     randomized either to the intervention group, who received 9 group sessions over a period of 3     months additionally to the standard vocational training (Social Competence Training for     Adolescents with Borderline Intelligence, SCT-ABI) or to the control group who received only     the standard vocational training. Outcome measures at the end of the intervention and at a     6-months follow-up assessment comprise self-reports, caregiver-reports, and behavioural     observations of cognitive, emotional, and behavioural factors of social competence.   "
217125|NCT00692094|"     The primary focus of this five-year study will be to optimize the melatonin dosing regimen     for synchronizing the body clocks of elderly blind individuals to the 24-hour day.   "
217126|NCT00692107|"     3-D conformal radiotherapy offers the opportunity to reach higher tumor doses with acceptable     complication rates compared to conventional radiotherapy. There are retrospective and     preliminary prospective reports of a better local control / disease free survival (including     PSA control) using higher tumor doses. A prospective randomised phase III study is required     to validate these reports. The purpose of this randomized phase III study is to investigate     and compare the tumor control and toxicity in prostate cancer patients treated to 68 Gy and     78 Gy;   "
217276|NCT00698230|"     Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin     therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.   "
217133|NCT00692198|"     Chronic obstructive pulmonary disease (COPD) is a serious respiratory disease in which the     airways in the lungs are partially blocked, resulting in symptoms of chest tightness,     coughing, and difficulty breathing. Currently, there are many available treatments for     managing COPD symptoms and improving quality of life, including medications, lifestyle     changes, oxygen therapy, and pulmonary rehabilitation. For people with severe COPD that is     characterized by very low blood oxygen levels at rest, long term oxygen therapy can help to     prolong life and promote feelings of well-being. However, the effectiveness of supplemental     oxygen therapy for people with COPD that is characterized by only moderately low blood oxygen     levels at rest or normal blood oxygen at rest and desaturation on exercise is not known. This     study will evaluate the effectiveness of supplemental oxygen therapy in treating people with     COPD who have moderately low blood oxygen levels at rest or who have normal blood oxygen     levels at rest, but have low or very low blood oxygen levels during exercise.   "
217134|NCT00692211|"     We will evaluate if we can increase colorectal cancer screening rates by directly sending     screening tests to patients rather than waiting for them to come to clinic visits. We are     also evaluating a new test--fecal immunochemical tests--which does not require patients to     make dietary or medication changes. We will see if patients are more likely to complete these     tests than the standard fecal occult blood tests.   "
217135|NCT00692224|"     The purpose of this study is to determine the effect of 10 mg of oral zinc given daily     between days 2 and 7 of life to term or near term neonates with serum bilirubin levels of     more than 6 mg/dL at 24 ± 6 hours of life on hyperbilirubinemia and phototherapy.   "
217136|NCT00692237|"     Type 2 Diabetes Mellitus (T2DM) represents a model of endothelial dysfunction, where chronic     nitric oxide deprivation, hyperglycaemia and hyperinsulinemia and fibrogenic mediators lead     to cardiovascular remodelling associated with diabetic cardiomyopathy and in consequence to     secondary complications of diabetes. Specific anti-oxidative and anti-fibrotic therapies are     not currently available. Sildenafil (Viagra) has demonstrated the capability of significantly     improving endothelial dysfunction and cardiac fibrosis in experimental animal models.      The purpose of the present study is performed to establish the effect of chronic high dose     sildenafil treatment on heart performance in diabetic subjects.   "
217137|NCT00692250|"     This study is designed to assess any potential interaction between colesevelam and     ciclosporin in healthy volunteers.   "
217138|NCT00692263|"     Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a     single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and     pharmacodynamic(PD) measurements are done for the next 24 hours.      It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is     seen in Pk or PK of tramadol   "
217139|NCT00692276|"     The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the     safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy     adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been     unresponsive to conservative care.   "
217140|NCT00692289|"     This is an open label, non-interventional quality of life analysis for Arimidex treated     postmenopausal patients in early breast cancer by investigator's questionnaire   "
217141|NCT00692302|"     This study will evaluate the effectiveness of an individually tailored suicide prevention     treatment program called SAFETY in reducing suicide and suicide attempts in adolescents.   "
217158|NCT00696683|"     This retrospective study was conducted to collect data from approximately 100 patients from 6     months to 18 years of age who were stung by a scorpion but were not treated with antivenom.     The study consisted of a review of hospital records of patients who were admitted for     intensive care management of scorpion envenomation, at the only two hospitals in North     America known to admit children routinely for scorpion sting management without antivenom.     The standard of care consisted of symptomatic and supportive care, including airway     maintenance, fluid and electrolyte support and, if necessary, sedation.   "
217159|NCT00696696|"     This study tests the combination of two targeted therapies,along with chemotherapy treatment     in the treatment of pancreatic cancer.   "
217142|NCT00692315|"     An open label trial was undertaken in 40 autistic children to determine whether treatment     with metabolic precursors methylcobalamin and folinic acid would improve plasma biomarkers of     oxidative stress and measures of core behavior using the Vineland Adaptive Behavior Scales     (VABS). Metabolites involved in methionine and glutathione synthesis and VABS behavior scores     were measured before and after a three month intervention period.      The results indicated that pre-treatment metabolites in autistic children were significantly     different from values in age-matched control children. The three month intervention resulted     in significant increases in cysteine, cysteinylglycine, and glutathione (GSH, p < 0.001). The     oxidized disulfide form of glutathione (GSSG) was decreased (p < 0.008) and the glutathione     redox ratio (GSH/GSSG) was increased after treatment (p < 0.001). Although significantly     improved, these metabolites remained below control levels after intervention (p > 0.01).     Similarly, increases in VABS composite score and sub-scores for Socialization, Communication,     and Daily Living Skills increased after treatment (p < 0.007) but also remained below     standard scores.   "
217143|NCT00692328|"     To investigate how levodopa and acupuncture affect fatigue and muscle function in people who     suffer from Parkinson's disease. Subjects may choose to participate in levodopa or     acupuncture part, or both. Study procedures include an exercise protocol, transcranial     magnetic stimulation (a non-invasive type of brain stimulation that cause small muscle     twitch), a blood draw, and personality surveys.   "
217144|NCT00692341|"     This study will evaluate the effects of mild and moderate impairment of hepatic function on     the single-dose pharmacokinetics, safety and tolerability of AG-013736.   "
217145|NCT00692354|"     The primary objective of this study was to determine the safety, tolerability, dose-limiting     toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once     daily, to patients with advanced solid tumours.      The secondary objectives of this study were:        -  To determine pharmacokinetic parameters for CHR-2797 when administered orally at          increasing dose levels;        -  To investigate the pharmacodynamic effects of CHR-2797 in blood mononuclear cells and,          when possible, tumour cells; - To enable a preliminary assessment of anti-tumour          activity of CHR-2797.   "
217146|NCT00692367|"     The primary objective of this study will be to determine the effects of physical activity in     patients during substantial surgery-induced weight loss.      A randomized controlled physical activity intervention trial in a group of patients     undergoing bariatric surgery for weight loss. The study will involve two sites with an active     bariatric surgery program, which have a strong track record of bariatric surgery research.     The study will include 160-200 subjects. Changes in the primary outcome variables will be     determined in previous gastric bypass patients as a result of 6 months of moderate physical     activity compared to an educational control group not engaged structured exercise.   "
217147|NCT00696527|"     The purpose of this observational study is to describe radiological, clinical and     histological characteristics of women with infiltrative breast cancer.   "
217150|NCT00696566|"     The principal research question is: Can platelet P2Y12 receptor blockade by the     antithrombotic drug clopidogrel be significantly enhanced by coadministration of the     antibiotic rifampicin?      Clopidogrel is an antithrombotic drug in clinical use that reduces the risk of heart attack     and coronary stent thrombosis. However some patients respond poorly to clopidogrel, at least     partly because they fail to convert it effectively to its active form, and consequently are     at higher risk of arterial thrombosis. Preliminary evidence indicates that the antibiotic     rifampicin enhances the effectiveness of clopidogrel by increasing its conversion to its     active form by the liver. We wish to study further the extent of rifampicin's effect on     clopidogrel to see whether this might be useful in clinical practice.   "
217151|NCT00696579|"     A significant number of patients with high risk superficial bladder cancer has progression to     invasive disease. No consensus exists regarding the optimal treatment to decrease the     recurrence and progression rate. The aim of this research is to evaluate the safety,     tolerability and efficacy of adjuvant intravesical gemcitabine vs. BCG in the treatment of     high-risk superficial bladder cancer   "
217152|NCT00696592|"     This phase II study was designed to evaluate the safety, tolerability, and efficacy of     bevacizumab treatment in conjunction with PDT at the low fluence rate compared with     bevacizumab alone or combined with PDT at the standard fluence rate, in patients with all     types of choroidal neovascularization secondary to AMD.      Hypothesis: bevacizumab in combination with PDT (low and standard fluence rate) will i) delay     time to retreatment, ii) reduce the average number of treatments required compared to     bevacizumab alone and iii) at low PDT fluence rate will improve long-term safety profile.   "
217153|NCT00696605|"     The are 2 principal goals in this study:        1. To measure plasma copeptin levels in healthy subjects and to correlate them with plasma          AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states.        2. To measure plasma copeptin concentrations in patients with chronic renal failure under          the same conditions described above, in order to characterize the impact of renal          function on circulating copeptin levels in correlation to plasma AVP and urine          osmolality.   "
217154|NCT00696618|"     This study is looking at 3 different types of enemas used before receptive anal intercourse     in men who have sex with men (MSM). We are investigating whether the enemas cause any damage     to the lining of the colon, how far up the colon the enemas travel after they are given, and     how much study participants like using each of the enemas.   "
217155|NCT00696631|"     The purpose of this study is to assess the efficacy, tolerability and safety of dronedarone     versus placebo in patients with symptomatic congestive heart failure (CHF) and left     ventricular dysfunction (LVD) when added to evidence based treatments for CHF.   "
217156|NCT00696644|"     This observational study will evaluate the incidence of new vertebral and non vertebral     fragility fractures in patients with severe osteoporosis treated with anabolic drugs. This     study will also evaluate BMD, compliance to treatment, back pain and the health-related     quality of life.   "
217157|NCT00696657|"     This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly     to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or     liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was     double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy     parameter was HbA1c and the treatment duration was 12 weeks.   "
217162|NCT00696735|"     Follicular lymphomas are a subgroup of B-cell non-Hodgkin lymphomas, accounting for 15% to     30% of newly diagnosed lymphomas.1-3 Median survival varies from 5 to 10 years depending on     the prognostic factors at diagnosis and response to first-line therapy.4-6 Whatever the     treatment, no plateau appears on survival curves, and virtually all patients relapse;     follicular lymphomas are ultimately progressive, and fatal.2,3,5 No reference first-line     treatment is clearly defined. One of the most active therapies is still doxorubicin-based     chemotherapy with or without interferon.7-9 New therapeutic approaches including purine     analogs and anti-CD20 monoclonal antibody are promising and are progressively included in the     management of these lymphomas.2,3,10-13 The role of high-dose therapy (HDT) as a salvage     treatment for patients with relapsing follicular lymphoma is demonstrated by some authors;     several reports have shown the superiority of HDT followed by autologous stem-cell     transplantation, purged or unpurged, compared with conventional chemotherapy in terms of no     relapse and overall survival.14-18 Only a few reports have been published showing HDT results     as a first-line treatment for poor-risk patients with follicular lymphoma, and the results     remain controversial.19-26 These data prompted the French Groupe Ouest-Est des Leucémies et     Autres Maladies du Sang (GOELAMS) to conduct a prospective randomized trial using patients     with newly diagnosed follicular lymphoma with a high tumor burden. A combined     doxorubicin-based chemotherapy associated with interferon was compared to front-line HDT     followed by purged autologous stem-cell transplantation.   "
217163|NCT00696748|"     The objective of the study is to assess the effect of the testosterone therapy on the body     composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic     syndrome and hypogonadism.   "
217323|NCT00698867|"     The purpose of this study is to perform a five-year, multi-center prospective evaluation of     the Discovery™ Elbow System for outcome and durability. Relief of pain and restoration of     function will determine long-term clinical outcome while durability will be measured by the     absence of revisions.   "
217164|NCT00696761|"     Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of     α1-blockers for treating BPH has been well documented and they are recommended for the     treatment of BPH by clinical guidelines.      It is not well known if a stratification based on the grade of BOO and bladder contractility     has any predictive value for patients who are treated with an α1-selective blocking agent. In     our study, we investigated possible differences in treatment outcome between patients with     and without BOO, and with or without proper contractility who are treated with alfuzosin. So     we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH     patients by the grade of BOO and/or bladder contractility.   "
217165|NCT00696774|"     The purpose of this study is to help answer the following research question: Whether     switching to duloxetine improves depressed mood when current treatment did not work well for     patients with depression.   "
217166|NCT00696787|"     The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of     pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.   "
217167|NCT00696800|"     To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa     (Organon 36286) to induce multifollicular development for controlled ovarian stimulation     using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single     injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in     initiating multifollicular growth.   "
217168|NCT00696813|"     The purpose of this non-interventional, observational and international registry study is to     document the prescribing patterns in daily clinical practice and to assess long term     treatment outcomes related to initiation of treatment with oral antipsychotics in a     naturalistic setting.   "
217169|NCT00696826|"     A study to compare the plasma concentrations of MK0431 at different times in patients with     hepatic insufficiency vs healthy control subjects.   "
217170|NCT00696839|"     The hypothesis is that participants in the intervention group will experience fewer/less     intense side effects from anti-HIV medications, if they receive training sessions on the use     of guided imagery, relaxation, and reframing of the medication-taking experience. Such     training is not part of the usual care of HIV patients.   "
217171|NCT00696852|"     In this study, we will conduct a preliminary, yet comprehensive evaluation of Mindfulness and     Yoga, as compared to an exercise and education-based stress-reduction program. and     simultaneous evaluation of the effect of an 8 week program of Mindfulness, 12 weeks of Yoga     practice, and 12 weeks of an exercise and education-based program.      105 otherwise healthy individuals, who have cardiovascular risk factors and mild to moderate     stress or anxiety will be randomly assigned to one of the three intervention groups: an 8     week program of Mindfulness, 12 week program of Yoga practice, and 12 week exercise and     education-based group program. All subjects will perform daily practice that will continue     after the weekly sessions end, allowing a follow up assessment at 24 weeks. Self-reported     mood and psychological distress and physiological indicators of function of the ANS and     stress hormones will be assessed at baseline, 8 weeks, 12 weeks and 24 weeks. Blood and urine     samples will be collected at baseline and 8 weeks to determine levels inflammatory and     atherosclerosis markers.      We anticipate that the study will provide information on the efficacy of the Mindfulness and     Yoga interventions as stress-reduction practices, variability in potential markers for     activation of the brain/cardiovascular system connections, and preliminary estimates of     effect size for each of these markers. Thus, the study will provide the data needed for     designing a future study that will rigorously address these questions in a larger, randomized     trial of Mindfulness and Yoga in patients with cardiovascular risk.   "
217172|NCT00696865|"     This multiple ascending dose study will evaluate safety and tolerability after repeated     ascending doses of AZD2624   "
217173|NCT00696878|"     The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin     alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated     COS cycles using a multiple dose GnRH antagonist protocol.   "
217174|NCT00696891|"     This study is conducted to compare the immunogenicity, reactogenicity and safety of     Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population   "
217175|NCT00696904|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333     in healthy volunteers and the antiviral activity in HCV infected subjects.   "
217177|NCT00696930|"     Subjects will be screened to determine OctreoScan® uptake. And upon meeting the eligibility     criteria, 90 subjects will complete a symptom assessment scale at baseline and throughout the     study at specific time points. Actual treatment will consist of three six-week cycles of a     fixed total dose of 13.3 GBq (360 mCi) of 90Y-SMT487. The total dose will be divided into     three equal doses and administered as a single activity of 4.4 GBq (120 mCi) of 90Y-SMT487     once every six weeks for three cycles. An amino acid infusion will be administered along with     each dose. Long-term follow up will occur at 6 and 12 months after Day 1/ Cycle 1. Survival     will be assessed every six months.   "
217178|NCT00696943|"     The purpose of this study is to evaluate the potential of [18F]-ML-10 to serve as a     non-invasive imaging tool for the early detection of apoptosis in brain metastases in     response to radiation therapy, in patients subjected to stereotactic radiosurgery (SRS). Such     early detection may improve clinical management of patients with brain metastases, as it may     help early identification of non-responders, and subsequently potentially lead to     optimization of radiation techniques such as the need for whole brain radiation therapy     (WBRT), addition of brain penetrating chemotherapy or an early decision on referral of the     patient with non-responsive lesions to surgery or to systemic chemotherapy. The experimental     design of the present study aims to evaluate the potential of non-invasive PET examination     with [18F]-ML-10, to provide the clinician with an assessment of response early in the course     of treatment, via non-invasive molecular imaging of radiation-induced apoptosis. This     information on tumor responsiveness is currently available only several weeks to months after     completion of radiotherapy.   "
217735|NCT00695669|"     The purpose of the study is to characterize the immunogenicity & safety of 2 doses of GSK's     avian flu vaccine GSK 1557484A given according to different regimens to adults aged 18 to 64     years   "
217179|NCT00696956|"     The study will be performed as a randomized, double blind trial (in respect of the primary     end point) with treatment of the stenotic lesion using uncoated PTA-catheters as control     group. 114 patients will be included in the trial at about 5 study centers. Follow-up     includes control angiography after 6 and 18 months and clinical follow-up examinations up to     18 months. Primary objective:      Efficacy of paclitaxel coated PTA balloons in inhibiting restenosis of below the knee     arteries (late lumen loss)      Secondary objective:      Various angiographic and clinical efficacy measures, safety and tolerance of pacli-taxel     coated PTA balloons in inhibiting restenosis of below the knee arteries Descriptive     statistics, comparison by t-test, chi-square test for binary events 10.1 Descriptive     statistics As far as applicable descriptive statistics will be applied to data and will be     referring to individual changes versus baseline (predilatation or immediately     postdilatation). The groups will be compared to each other testing the statistical     significance of differences (p ≤ 0.05). Con-tinuous data will be expressed as mean ± standard     deviation.      Categorical variables will be compared using the chi-squared test, and continuous variables     will be compared using Student's t test or ANOVA analysis.      In addition to the assessment of the primary endpoint and the secondary endpoints a     multi-variate analysis to investigate the influence of risk factors on the interventional     outcome (interventional success, early restenosis/occlusion, LLL, stent integrity) and     clinical outcomes will be performed. For this analysis the following factors will be     considered: age, diabetes, neurological status (only Rutherford 5), lesion length, grade of     dissection and calcification, reststenosis, number of run-off vessels, stent administration     in the index lesion(s).      10.2 Estimated number of patients The primary endpoint of the study is late lumen loss (LLL)     at 6 months evaluated by quantitative angiography. Because no data according this endpoint     are available for both the control group and the group which will be treated with the     paclitaxel coated balloon an assumption according the LLL at 6 months was made according the     expectations of the principle investigator. An estimate for LLL as % of MLD in the control     group is 50% and in the drug coated balloon group 30 %. The standard deviation is calculated     to be 30% of LLL. A sample size of 37 patients in each group will allow the detection of a     statistically significant difference (p<0.05) with 80% power. Based on the Below study     which enrolled patients with comparable arterial lesions in Tuebingen and the data of the     Basil study, it is estimated that 35% of the patients who will be enrolled in the study will     not be available for follow-up investigations in order to calculate the MLD.      In order to meet a statistical endpoint a total of 114 patients will be enrolled.   "
217180|NCT00696969|"     The overall objective of this trial is to identify a safe and effective combination,     (coadministration) short course treatment for the treatment of visceral leishmaniasis which     could be easily deployed in a control programme and will reduce the risk of parasite     resistance occurring.      Safety and tolerability should be such that the combination can be easily deployed.   "
217181|NCT00696982|"     Recently a new category of antihyperglycemic therapy aiming to modulate the incretin system     has emerged. These drugs induce insulin secretion without inducing hypoglycemia. The effect     of the incretin modulators drugs on hypertension, arterial stiffness, inflammation and     oxidative stress parameters have not been fully investigated yet.GLP-1 analogue has been     suggested to have an effect on endothelium and the development of hypertension. Nystrom et al     have demonstrated that GLP-1 improves endothelial dysfunction in a small group of type 2     diabetes subjects, with coronary heart disease. We hypothesize that DPP-4 inhibitor will have     an effect on hypertension and arterial stiffness by effect on the NO pathway.The aim of this     study is to investigate the effect of two insulin inducers drugs, sulfonyl urea and DPP-4     inhibitor on 24 hours blood pressure monitoring, arterial stiffness, oxidative stress and     inflammation.   "
217182|NCT00696995|"     This study is conducted in Europe. The aim of this observational study is to evaluate the     incidence of serious adverse drug reactions when initiating or switching to insulin therapy     with NovoMix® 30 in subjects with type 2 diabetes under normal clinical practice conditions   "
217183|NCT00697008|"     To evaluate symptomatic outcome and HRQoL in GERD patients treated following a new CP     Guideline.   "
217184|NCT00697021|"     TEG is an established technique to assess the quality of clot formation' used mainly in     surgery and obstetrics to determine possible bleeding diathesis. Recently it became to be     used in cardiology, where it can be a valuable tool to assess a response to antiplatelet     therapy and its association with the outcome. However, there is a few data about use of TEG     in STEMI patients undergoing PCI. Our study is designed to assess by TEG the platelet's     response to clopidogrel treatment during acute STEMI in patients undergoing primary PCI and     the correlation of this response with the long term outcome, and ability to dose adjustment     according to a specific measurement by TEG in order to prevent future MACE.   "
217185|NCT00697034|"     The purpose of this research study is to examine the role of nerves in the skin in psoriasis     and to better understand the effects of capsaicin in psoriasis.In this study, capsaicin will     be compared to a moisturizer (aquaphor ointment).   "
217199|NCT00697216|"     This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine     administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month     vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.   "
217200|NCT00697229|"     The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of     MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in     healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months   "
217186|NCT00697047|"     SOS is a four-arm randomized controlled study of ways to increase screening for colorectal     cancer. About 40-50% of the people age 50 and older are not up to date on screening. This is     a very important problem because screening both prevents colorectal cancer and decreases     colon cancer deaths.      We are studying 3 different levels of support to help people get screened and follow-up after     positive screening tests. These involve comparing to usual care stepwise increasing in     intensity approaches; an automated approach of mailing information and home screening tests,     this plus phone assistance by a medical assistant, both of these plus phone counseling and     care management. We will also compare nurse assisted follow-up after a positive screening     test compared to usual care      By doing this study we hope to increase colon cancer screening rates, and also follow-up     rates for positive screening tests.   "
217187|NCT00697060|"     Protocol AMP-024 is a Phase 2 study of imexon plus docetaxel for patients with previously     treated lung cancer that has spread in the body. Docetaxel is approved by the Food and Drug     Administration (FDA) as a second line therapy for this cancer. The imexon is administered on     days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is     to determine if the combination of imexon plus docetaxel is safe and effective.   "
217188|NCT00697073|"     This study is meant to assess the safety and tolerability of idebenone in patients with     Friedreich's Ataxia over a 12 months period.   "
217189|NCT00697086|"     The purpose of this study is to assess the efficacy of dronedarone for the control of     ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to     assess the tolerability of dronedarone in the target population.   "
217190|NCT00697099|"     The primary objective was to compare the efficacy of once daily [q.d.] subcutaneous [s.c.]     injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of enoxaparin for the     prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective total hip     replacement surgery.      The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing     elective total hip replacement surgery, and to document AVE5026 exposure in this population.   "
217246|NCT00697827|"     The purpose of this study is to evaluate the safety and effectiveness of the In-Space     compared to the X STOP Interspinous Process Distraction (IPD) device (X STOP) for the     treatment of patients experiencing intermittent neurogenic claudication secondary to moderate     degenerative lumbar stenosis at one or two lumbar levels.   "
217191|NCT00697112|"     The purpose of this observational study is to examine the clinical outcomes of the use of     sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD)     under conditions of routine clinical practice. The primary objective is to identify the     current criteria/reasons to use sirolimus as base therapy in this selected population and     define and understand the emerging patterns of immunosuppressive treatment with sirolimus.   "
217192|NCT00697125|"     The purpose of this study is to evaluate the immunogenicity and reactogenicity of various     formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult     volunteers following the 0, 1, 6 months schedule   "
217193|NCT00697138|"     Cocaine dependence is a significant public health concern. The proposed research will provide     important clinical information regarding the efficacy of agonists replacement therapies for     managing cocaine dependence.   "
217194|NCT00697151|"     The study sought to assess the rate of recurrent stroke and death in stroke patients with a     patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter     study conducted at 48 U.S. Institutions.   "
217195|NCT00697164|"     Malaria remains one of the most common life-threatening illnesses in the tropics with a     dramatic toll of more than one million deaths each year. A majority of malaria cases are     non-complicated and only few evolve towards severe malaria resulting from the combination of     parasite-specific virulence factors and host inflammatory responses. Cerebral malaria (CM)     kills more than 1 million African children each year. CM carries a fatality rate of about 20%     in adults, higher in children, despite timely and adequate chemotherapy. Moreover, the more     rapid clearance of parasitaemia with new antimalarial drugs is not associated with improved     survival, suggesting the potential interest for adjunctive therapies in the early phase of     the disease.      Cerebral malaria leading to seizure and coma is associated with severe intracranial     hypertension caused by brain-swelling. Recent imaging and post-mortem findings in adult     cerebral malaria have confirmed the presence of diffuse cerebral oedema with thalamic and     cerebellar white matter hypoattenuation, diffuse petechial hemorrhages and symmetric ischemic     changes involving the thalamus and the cerebellum. However, the nature of the pathogenetic     processes leading to cerebral malaria is incompletely understood but mechanisms linking     cytokines with endothelial cells activation in the cerebral microvasculature have been     recently stressed. The effect of new neuroprotective therapies has not yet been investigated,     although the manifestations of cerebral malaria partly share features with neurological     stroke or acute non-specific neurological disorders. The hormone erythropoietin (EPO) is     probably one of the more enthusiastic drugs in this area.      EPO is as a member of type I cytokine superfamily with multiple functions, including a     prominent role for erythropoiesis and neuroprotection. Systematically administered EPO     crosses the blood brain barrier via the abundant expression of EPO receptors at brain     capillaries, and acts as an anti-apoptotic and cytoprotective cytokine. Moreover, EPO     prevents inflammation by inhibiting pro-inflammatory cytokines including TNFα, preserves     endothelial cells integrity and prevents blood-brain barrier permeability. We propose a     randomized clinical trial to investigate the safety and efficacy of EPO in patients     presenting cerebral malaria and hospitalized at Gabriel Toure hospital, Bamako, Mali, to     reduce the incidence of premature death in hospitalized patients.   "
217196|NCT00697177|"     Gastric reflux into the oesophagus may further lung damage in respiratory disease. The     proportion of adults with chronic lung disease and gastric reflux is unknown. Adults with     this disease regularly complete physiotherapy but the contribution of physiotherapy to reflux     is unknown. This study will measure gastric reflux in adults with chronic lung disease, using     24 hour acid monitoring. It is anticipated that approximately 50% of adults with chronic lung     disease will have gastric reflux. After monitoring, the number of gastric reflux episodes     will be calculated. The results will identify the extent of the gastric reflux problem in     these patients and will enable appropriate medical treatment and modifications to     physiotherapy, which may improve lung function and quality of life.   "
217197|NCT00697190|"     This study will evaluate the fitting characteristics and physiological response of two toric     lenses manufactured by Vistakon.   "
217198|NCT00697203|"     This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with     pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised     to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po     daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The     anticipated time on study treatment is 3 months and the target sample size is 100-500     individuals.   "
217202|NCT00697255|"     The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286)     regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily     dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone     (recFSH) can induce monofollicular growth (one follicle ≥18 mm and no other follicle ≥15 mm     at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.   "
217203|NCT00697268|"     This study will compare levels of p11 protein in people with and without major depressive     disorder (MDD) and examine if p11 levels in patients are affected by treatment with     citalopram (Celexa).      Healthy normal volunteers and patients with chronic or recurrent major depression between 18     and 65 years of age may be eligible for this study.      Participants undergo the following tests and procedures:      Healthy Volunteers        -  Psychiatric interview and medical examination, questions about family history        -  Blood draw      Patients with MDD      Phase 1 - Evaluation and Discontinuation of Medications        -  Physical examination, electrocardiogram, blood tests        -  Gradual antidepressant medication withdrawal, followed by 2- to 6-week drug-free period.          If needed, medicines for anxiety and difficulty sleeping may be prescribed.      Phase 2 Citalopram Treatment        -  Start daily citalopram treatment        -  Evaluations at the start of phase 2 and every week for 8 weeks with following          procedures:        -  Symptoms ratings interview and questionnaires        -  Review of side effects and new medications        -  Blood pressure and pulse measurements        -  Blood and urine tests      At the end of the study, plans are developed for long-term treatment and transfer of care to     the patient s own physician.   "
217204|NCT00697281|"     The primary objective of this study is to evaluate a range of dose levels for efficacy in the     control of symptoms of allergic rhinitis   "
217205|NCT00697294|"     Vitamin D deficiency is widespread and linked to decreased bone mineral content. Little data     exists regarding the vitamin D status and the relationship of 25-hydroxyvitamin D (25-OHD)     status to functional bone health outcomes in Hispanic infants. To evaluate this, we plan an     observational cohort of full term, healthy, exclusively breastfed Hispanic and Caucasian     infants. We hypothesize serum 25-OHD measured in cord blood will be significantly lower in     Hispanic than Caucasian infants, with 25-OHD less than 20 ng/mL found in at least 50% of     Hispanic neonates. Secondary aims evaluate the relationship between 25-OHD levels and bone     mineral status at baseline and after 3 months of 400 IU/day supplemental vitamin D3. Whole     body bone density scan (DXA) and bone ultrasound (SOS U/S) will be measured shortly after     birth, then again after supplementation. Data from this study will provide information needed     to design further randomized trials and interventions.   "
217206|NCT00697307|"     The purpose of this study was to determine the bioequivalence of a norelgestromin/ethinyl     estradiol (NGMN/EE) transdermal contraceptive system.   "
217207|NCT00697320|"     This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to     observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German     clinics. The observational study observes patients with congenital haemophilia with     inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII     deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven®     for treatment of a bleeding episode or for the prevention of a bleeding when undergoing     surgery or an invasive procedure.   "
217208|NCT00697333|"     Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on     a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic     tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of     FDG-positive lesions.      Primary endpoint is the local disease control in the chest.   "
217209|NCT00697346|"     This is an open-label, multicenter, phase 1 study of MLN8237 in participants with advanced     hematological malignancies for whom there are limited standard treatment options.   "
217210|NCT00697359|"     The primary aim of the study is to assess the efficacy of continuous rhythm monitoring with     an implantable loop recorder (ILR) compared to conventional ambulatory electrocardiography in     detecting episodes of atrial fibrillation after pulmonary vein isolation (PVI). The secondary     aim is to assess the efficacy of PVI during a two years follow-up and to assess the     reliability of the implantable loop recorder in detecting atrial fibrillation.      50 patients will be enrolled into the study. After enrollment an implantable loop recorder     will be implanted at least 6 weeks before scheduled PVI. All patients will be followed for 24     months after PVI. During the follow-up period a 72-hours ambulatory electrocardiographic     monitoring will be performed at 1, 6, 12, 18, and 24 months. Transthoracic echocardiography     will be performed at enrollment, 3, 12, and 24 months after PVI. Moreover, quality of life     will be assessed at baseline, and 6 and 12 months after PVI.   "
217211|NCT00697372|"     BACKGROUND:      Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI). The     selection of the type of DES and the technique for stent implantation have not been     clarified. The side-branch (SB) is emerging as critical point, accounting for more than a     third of the significant restenosis in the DES era. A series of data supports the adoption of     a conservative strategy: stenting the main vessel (MV) only and reserving a conservative     approach on the SB. Yet, the clinical relevance in terms of inducible ischemia of sub-optimal     angiographic result has not been clarified.      AIMS OF THE STUDY:      The aims of the present study are:        1. to compare in a prospective randomized study the acute 3D angiographic results and the          late clinical outcome of Sirolimus-eluting (SES) vs Everolimus-eluting stent (EES)          obtained using a provisional TAP-stenting technique.        2. to prospectively assess the clinical relevance (inducible ischemia) of suboptimal          angiographic result in the SB after stenting.      METHODS TO BE APPLIED:      150 consecutive patients with bifurcated lesions undergoing PCI with the provisional     TAP-stenting technique will be randomized to SES or EES implantation. Procedural and post-PCI     details will be prospectively recorded. The subgroup of patients in which complete     revascularization has been achieved will enter a systematic assessment of inducible ischemia     by early and late exercise tests.      Off line 3D QCA assessment will be performed and used to divide the study population in 2     groups according to the SB residual stenosis:        -  Group O (optimal SB angiographic result): post-PCI SB area stenosis<50%        -  Group S (sub-optimal SB angiographic result): post-PCI SB area stenosis>50%.      PRIMARY STUDY END-POINTS.        1. COMPARISON BETWEEN SES AND EES:           SB acute angiographic result; SB trouble; target bifurcation failure.        2. SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization:          inducible ischemia at the early exercise test or occurrence of early spontaneous          ischemia related to the SB.   "
217212|NCT00697385|"     The high percentage of failure using available non-surgical options to treat menorrhagia in     women with bleeding disorders shows a continuing need for innovative treatments. This has led     to development of this protocol in order to make available tranexamic acid as a potentially     effective menorrhagia therapy option in women with an underlying bleeding disorder. We     anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in     bleeding disorder patients.   "
217214|NCT00697411|"     Based on our current understanding of Aicardi syndrome, the condition is hypothesized to     occur due to a genetic change on the X-chromosome. Our team is investigating Aicardi syndrome     to identify the specific gene location associated with the disorder. We are collecting blood     and skin biopsy samples from patients and their parents. A permanent cell line is prepared     and DNA from the blood and skin samples and cell lines is isolated and then used for genetic     testing. Our current research includes microarray analysis which we are using to look for     duplications or deletions of genetic material, mutation analysis of candidate genes by     sequencing, review of medical records to identify trends suggesting possible candidate genes     of interest, and X chromosome inactivation studies.   "
217227|NCT00697580|"     We are conducting an intervention study to examine the effects of a 16-week exercise and diet     interventions on prevention of disease, specifically type 2 diabetes and heart disease, in     Latino youth. Eighty overweight Latino boys and girls will be recruited and placed in one of     the following intervention groups: 1) Control Group (delayed intervention), 2) Dietary     Education Group (nutrition education focused on reducing sugar & soda, increased fiber &     whole grain intake), 3) Combination of Strength Training (twice/week for 60 min, progressive     increases in exercise volume and intensity) + Dietary Education (nutrition education focused     on reducing sugar & soda, increased fiber & whole grain intake) or 4) Combination of Circuit     Training (twice/week for 60 min, aerobic + strength training exercises) + Dietary Education     (same as above). We will assess which intervention group has the most effects on health     parameters such as weight, body composition, and insulin related measures.   "
217215|NCT00697424|"     Obstructive Sleep Apnoea (OSA) is a common sleep-breathing disorder affecting around 2-4% of     the population and is characterised by loud snoring, periodic collapse of the upper airway     particular to sleep, sleep fragmentation, and sometimes daytime sleepiness. Health     consequences include impaired cognitive functioning, quality of life, mood, and increased     cardiovascular disease risk. Epidemiological studies have demonstrated that increased     morbidity and mortality in a dose response manner with increasing severity of sleep     disordered breathing.      The standard treatment for OSA is nasal Continuous Positive Airway Pressure (CPAP), which     consists of pressurized air applied to the nose via a mask. Generally a single, optimal     pressure is prescribed for a patient based on a full night or partial night study during     which the pressure is adjusted by a technician until all sleep disordered breathing (SDB)     events are abolished. Despite therapy efficacy, compliance to CPAP therapy is sub-optimal.      Due to low compliance it has become common for healthcare providers to follow up subject     therapy efficacy through reporting software inherent in many current CPAP devices. Healthcare     providers can use this reported data to make appropriate treatment decisions. For this reason     the data needs to be accurate. The SleepStyle™ 200 Auto Series CPAP humidifier is an auto     adjusting CPAP which stores comprehensive compliance data. The aim of this study is to     compare the reliability of the SleepStyle™ 200 Auto Series CPAP data to laboratory-based PSG     in detecting sleep disordered breathing.      Hypothesis: The SleepStyle™ 200 Auto Series reporting features accurately detects indices of     sleep disordered breathing.   "
217216|NCT00697437|"     Primary Objective:        -  To confirm if ketoconazole inhibition of CYP3A activity affects fractional excretion of          docetaxel in the urine.      Secondary Objective:        -  To compare the metabolite ratios of the major metabolites of docetaxel in the presence          and absence of CYP3A inhibition.   "
217217|NCT00697450|"     This study is conducted in Europe. Observational study evaluating the body weight progress     during the treatment with insulin detemir (Levemir®) in Type 2 patients, previously treated     with other basal insulins   "
217218|NCT00697463|"     Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young     individuals sustain one or more low-trauma fractures. Teriparatide [PTH(1-34)], which is FDA     approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating     bone formation. We hypothesize that teriparatide will significantly increase bone density     (BMD) and improve bone structure in premenopausal women with IOP.   "
217219|NCT00697476|"     The purpose of this study is to evaluate the maximum tolerated dose, the activity and the     safety profile of the combination of vorinostat and topotecan in patients with recurrent     small cell lung cancer   "
217220|NCT00697489|"     The incidence of pelvic organ prolapse (POP) in parous women is estimated over 50%. A variety     of urinary, bowel and sexual symptoms may be associated with POP. Moreover, a proportion of     women who underwent a surgical correction of POP may occur post-surgical urinary incontinence     and, thus, if this last presents as genuine stress-type or mixed-type, a second surgical     intervention may be required. At this proposal, with the aim to reduce the incidence of     postoperative urinary incontinence, the addition of a preventive continence procedure to a     POP repair intervention has been widely proposed, but the potential benefits needs to be     balanced against potential disadvantages.      Based on these considerations, the aim of this trial will be to compare two different     surgical strategies for women with POP without urinary stress incontinence. Specifically, the     efficacy to associate and to follow a preventive continence procedure to the correction of     POP will be compared.   "
217221|NCT00697502|"     Hypothesis:      Patients with TYMS 2R/2R or 2R/3R appear to be more sensitive to fluoropyrimidines,     conferring a higher risk of grade 3-4 fluoropyrimidine related toxicity and a higher response     rate compared with 3R/3R. The genotype 3R/3R is more common in East Asia and is associated     with greater tolerability to fluoropyrimidine as measured by lower toxicity but also lower     response rates. As sensitivity to fluoropyrimidine appears to be affected by TYMS genotype,     we hypothesise that patients with TYMS 3R/3R are more tolerant to standard doses of     capecitabine and require higher doses to overcome fluoropyrimidine resistance. We designed     this study to develop TYMS genotype specific dosing of capecitabine.      Aims:        1. To determine the maximal tolerated dose (MTD) of capecitabine twice a day for two weeks          followed by one week rest period (intermittent schedule) in patients with the advanced/          and or metastatic cancer based on TYMS genotype.        2. To determine a suitable phase II dose of intermittent schedule capecitabine.        3. To determine the safety and toxicity of this regimen.        4. To perform plasma pharmacokinetics of capecitabine.        5. To determine the relationship between genes of relevance in the fluoropyrimidine pathway          with pharmacokinetics and toxicity.   "
217222|NCT00697515|"     To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult     workplace environment (AWE) setting   "
217225|NCT00697554|"     The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated     with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B. The     immunogenicity and safety of the novel adjuvanted vaccine will be compared to Engerix™-B as     the control vaccine   "
217226|NCT00697567|"     The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is     to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate     vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.   "
217228|NCT00697593|"     To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic     or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or     phototherapy dose.   "
217245|NCT00697814|"     Prolactinomas are usually associated with hypogonadotropic hypogonadism in both sexes.     Clomiphene citrate is a well known selective estrogen receptor modulator that increases     gonadotropin secretion via hypothalamic-pituitary action. We conducted a prospective, open     label clinical trial of CC to evaluate its effects in reverting persistent HH in male     patients with prolactinomas under dopaminergic agonist treatment.   "
217229|NCT00697606|"     Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such     diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and     surgeons suffer when adhesions are encountered, since the surgery becomes more intense,     lengthy, and complicated. Seprafilm® has been shown to limit the formation of adhesions in     gynecologic and abdominal surgery. Limited data is available on the effectiveness of     Seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean     section. Adhesions at the time of repeat cesarean make the surgery frustrating and complex,     with difficult lysis of adhesions being the cause of morbidities such as bladder damage,     increased blood loss, and longer operating times. The objective of this definitive project is     to define the extent of reduction of adhesion formation of Seprafilm® when used at the time     of primary cesarean section. Women undergoing primary cesarean section will be randomized for     Seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be     determined.   "
217230|NCT00697619|"     The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic     treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy     variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal     patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic     treatment alone.   "
217232|NCT00697645|"     This study will determine the safety and efficacy of transcranial magnetic stimulation (TMS)     in treating acute ischemic stroke (stroke resulting from a blood clot in the brain).      TMS was found to be effective and safe in the set up of depression. TMS acts by generating     magnetic fields in the brain which simulate neuro-chemical changes and stimulate neuronal     activity translating into increased secretion of growth factors such as brain derived     neurotrophic factor (BDNF). This is followed by positive effects of these growth and survival     factors on neuronal sprouting, re-organization and also potentially on neurogenesis. Hence it     is postulated that TMS will have a positive effect on the recovery rate and extent of     recovery after stroke. Brainsway innovative project involves the development and use of deep     Transcranial Magnetic Stimulation in humans to treat a host of behavioral disorders,     including depression and addiction. Brainsway developed a novel coil design for stimulation     of deep structures in the human brain and conducted several safety and efficacy studies and     recently completed a large study (70 subjects) demonstrating effectiveness in depressive     patients. Deep TMS produces directed electromagnetic fields that can induce excitation or     inhibition of neurons deep inside the brain. The treatment is non-invasive, with no     significant side effects, and no need of hospitalization or anesthesia. Consistent with     animal studies using brain stimulation deep TMS of the prefrontal cortex was found to exert     potent antidepressant effects on patients not previously responsive to antidepressant drugs     in two different studies. Therefore, it is expected that TMS will also be safe in patients     with stroke.      Patients between 18 and 80 years of age who have had a mild or moderate acute stroke may be     eligible for this study. Candidates will be screened with a medical history and physical     examination, blood tests, rating of neurological deficits such as cognition deficits or     problems walking that resulted from the stroke, and a computed tomography (CT) or a magnetic     resonance (MRI) scan of the head. CT involves the use of specialized X-rays and MRI involves     a magnetic field to obtain images of the brain.      All participants will receive standard medical and rehabilitation therapy for stroke. In     addition, patients recruited for the study will receive x sessions of TMS with the Brainsway     device delivered over the motor strip of the affected hemisphere. Each session will last for     y minutes. Sessions will begin on day 3 after stroke onset and will be given on an alternate     day basis for 14 days (7 treatments). Patients will be monitored daily until discharge from     the hospital, or until day 17, whichever is earlier. Assessments will include physical     examinations and safety evaluations including blood tests to and MRI or CT scans to evaluate     both the response to treatment and side effects if needed. Patients will return for a     follow-up examination 30 and 90 days after treatment conclusion to evaluate their recovery     rate and functional status.   "
217233|NCT00697658|"     The purpose of this study is to explore efficacy, tolerability and safety of paliperidone     Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone     ER in a naturalistic setting.   "
217234|NCT00697671|"     The prognosis of pediatric patients with hematologic malignancies whose disease is primarily     refractory or those who experience a chemotherapy resistant bone marrow relapse is extremely     poor. When new agents or chemotherapeutic regimens are unable to induce remission in this     patient population, hematopoietic stem cell transplant (HSCT) is also a poor alternative.     Thus, in this very high risk group, additional attempts at remission induction with various     combinations of chemotherapy alone will unlikely improve outcome and will contribute to     overall toxicity. Alternative therapies are needed in these patients with chemotherapy     resistant disease.      Immunotherapy with natural killer (NK) cell infusion has the potential to decrease toxicity     and induce hematologic remission. NK cells can kill target cells, including leukemia cells,     without prior exposure to those cells. In patients undergoing allogeneic HSCT, several     studies have demonstrated the powerful effect of NK cells against leukemia. Furthermore, NK     cell infusions in patients with primary refractory or multiple-relapsed leukemia have been     shown to be well tolerated and void of graft-versus-host disease effects. In this high risk     group, complete leukemic remission has been observed in several of these patients after NK     cell infusion.      With the current technology available at St. Jude, we have developed a procedure to purify NK     cells from adult donors. This protocol will assess the safety of chemotherapy and IL-2     administration to facilitate transient NK-cell engraftment in research participants who have     chemotherapy refractory hematologic malignancies including acute lymphoblastic leukemia,     chronic myelogenous leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome, or     non-Hodgkin's lymphoma. In this same cohort, we will also intend to explore the efficacy of     NK cells infused in those participants who have chemotherapy refractory disease.   "
217235|NCT00697684|"     This study will examine the safety of clofarabine, TLI and ATG as a reduced conditioning     regimen prior to allogeneic transplantation. The impact of the conditioning regimen on the     presence of the circulating regulatory as compared to activated T cell populations will be     assessed.The recovery of DC populations post-transplant will be examined, along with the     effect of the regimen on disease free and overall survival.   "
217236|NCT00697697|"     The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic     children, 12 months to 8 years of age, over a 40-week period.   "
217237|NCT00697710|"     The purpose of this randomized, double-blind, placebo-controlled, sequential-cohort,     dose-escalation study was to assess the safety, tolerability, pharmacokinetics, and     pharmacodynamics of S-777469, a CB2 cannabinoid receptor agonist, in subjects with mild to     moderate atopic dermatitis.   "
217238|NCT00697723|"     The aim of this study is to evaluate the different performance of arterial and venous graft     with intra-aortic balloon pump support following coronary artery bypass.   "
217239|NCT00697736|"     Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in     particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension     (PAHT).      In one hand, this PAHT is an evolutionary turn in symptomatology and prognosis, and on the     other hand, the tracking and the analysis of its effects on the right ventricular function     are difficult with the conventional techniques.      So, the analysis of the right ventricular function appears capital, because:        -  it is recognized like an essential determinant of the symptoms and effort capacity,        -  its prevalence, physiopathology and prognostic values remain unknown in this pathology,        -  its interest in the starting of the treatment remains to be specified.      The aim of this trial is to identify in a population of 150 patients presenting a systemic     scleroderma without PAHT:        -  the incidence of a right ventricular dysfonction, evaluated by the analysis of the          myocardic regional function with myocardial tissular Doppler mode,        -  the physiopathology of this damage by correlation with the tests of respiratory function          and the not invasive hemodynamic datas at rest and exercise.        -  the prognosis value of the abnormalities of the right ventricular function by a          follow-up of these patients over a 5 years period.      This trial should allowed to define the place of the new right ventricular function markers     in the evaluation of the functional consequences, the forecast and perhaps the care of     systemic sclerodermic patients.   "
217240|NCT00697749|"     This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and     Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2     genotype   "
217241|NCT00697762|"     The purpose of the study is to evaluate the effectiveness and safety of adjunctive RWJ-333369     at a dose of 200 or 400 mg/day in comparison with placebo in Korean and Japanese partial     epilepsy patients who have poor seizure control with one or two antiepileptics (AEDs).   "
217242|NCT00697775|"     In this study the safety and immunogenicity of 2 different formulations of the candidate     HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to     that of Engerix™-B in healthy adolescents aged 11 to 15   "
217243|NCT00697788|"     Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care     units. We are studying whether this drug is cardiovascularly safe in pediatric patients who     have recently been burned.   "
217250|NCT00697879|"     CHR-3996 is one of a new class of anti-cancer agents - histone deacetylase inhibitors (HDACi)     - that has exhibited pleiotropic activity both in vitro and in vivo against a range of human     cancer cells. Regulation of the acetylation of both histone and non-histone proteins by     histone deacetylase enzymes is one of the key mechanisms involved in epigenetic control of     gene expression. HDACi have demonstrated activity in both in vitro cytotoxicity, and in vivo     tumour xenograft studies   "
217251|NCT00697892|"     The purpose of the study is to determine in healthy volunteers whether certain anti-HIV     medications (lopinavir/ritonavir and efavirenz) affect the drug levels of certain     anti-malarial medications (artesunate/ amodiaquine and artemether/ lumefantrine) and vice     versa. Since these drugs are degraded using overlapping pathways in the liver, it is     predicted that changes in both drug level and overall drug exposure will be observed.   "
217252|NCT00697905|"     The aim of the study is to assess if gemcitabine in combination with carboplatin as 1st line     chemotherapy in patients with metastatic or recurrent nasopharyngeal carcinoma has reasonable     efficacy and a favourable toxicity profile that warrants further comparative study. A     parallel group of randomly selected patients of equal number to the carboplatin and     gemcitabine combination arm will be treated with the cisplatin and 5-FU combination     chemotherapy (active control arm).      The hypothesis is that this combination of chemotherapy is at least as active and less toxic     than the reference regimen of cisplatin in combination with 5-fluorouracil (5-FU).   "
217253|NCT00697918|"     The purpose of this study is to evaluate the long-term safety of RWJ-333369 at doses between     200-800 mg/day in Korean and Japanese patients who have completed the preceding study     (333369-KJ-02).   "
217254|NCT00697931|"     The purpose of this study is to compare the immunogenicity and reactogenicity of the     adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected     according to a three dose schedule (0, 1, 6 months) in an adult non-responder population   "
217255|NCT00697944|"     To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in     intensive care patients with a sepsis and rising candida colonisation.      Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome®     administered with an interval of one week, in patiens with a high risk of developing a fungal     infection) should decrease the incidence of actual systemic infections.      The incidence of such actual fungal infections will be assessed directly and its impact on     patients' survival and intensive care resourches assessed   "
217256|NCT00697957|"     Ageing populations have made osteoporosis and fragility fractures a major public health     concern worldwide. Half of all women and 30% of all men will suffer a fracture related to     osteoporosis during their lifetime. While medical prevention of this immense problem is     impossible at population level, it is necessary to find efficient preventive strategies.     Exercise is one of the major prevention approaches because one reason behind the increasing     burden of osteoporosis is the modern sedentary lifestyle. However, the optimal type,     intensity, frequency, and duration of exercise that best enhances skeletal integrity are     still largely unknown.      We conducted a 12-month population-based randomized controlled exercise intervention in 120     premenopausal women. The aim was to investigate the effect of impact exercise on bone mineral     density, geometry and metabolism in healthy women with the intention of assessing the     intensity and amount of impact loading with a novel accelerometer-based measurement device.     Training effects on risk factors of osteoporotic fractures, physical performance and risk     factors of cardiovascular diseases were also evaluated.      This study demonstrated that 12 months of regular impact exercise favoured bone formation,     increased bone mineral density in weight-bearing bones, especially at the hip, and led to     geometric adaptations by increasing periosteal circumference. Bone adaptations had a dose-     and intensity-dependent relationship with measured impact loading. Changes in proximal femur     were threshold-dependent, indicating the importance of high impacts exceeding acceleration of     4 g as an osteogenic stimulus. The number of impacts needed to achieve this stimulation was     60 per day. Impact exercise also had a favourable effect on physical performance and     cardiorespiratory risk factors by increasing maximal oxygen uptake, dynamic leg strength and     decreasing low-density lipoproteins and waist circumference. Changes were dose-dependent with     impact loading at wide intensity range.      Bone adapts to impact loading through various mechanisms to ensure optimal bone strength. The     number of impacts needed to achieve bone stimulation appeared to be 60 per day, comparable to     the same number of daily jumps. If done on a regular basis, impact exercise may be an     efficient and safe way of preventing osteoporosis.   "
217257|NCT00697970|"     The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant     hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2     months with a booster at month 12   "
217258|NCT00697983|"     Background: Osteoporosis is a high-prevalence disease with a strong genetic component.     Nucleotides, including ATP (adenosine 5'-triphosphate) and its purinergic receptors, play a     role in bone physiology. Single nucleotide polymorphisms (SNPs) in the P2X7 receptor gene     were recently found to be associated with fracture risk in a cohort of postmenopausal women.      Objective: To investigate associations between purinergic receptor SNPs and osteoporosis risk     in humans. Genetic data from a fracture cohort in the Netherlands with high prevalence of     osteoporosis will be analyzed. Furthermore, effects of aberrant purinergic receptor     signalling on bone turnover markers will be assessed ex vivo.      Design: The cohort will include app. 1,000 fracture patients of 50 years and older, who will     be recruited at the Maastricht University Medical Center during standard medical follow-up     after a clinical fracture. The standard medical follow-up includes assessment of bone mineral     density (BMD) by Dual-Energy X-ray Absorptiometry (DXA), if necessary followed by medication     for osteoporosis. Prior to medication, blood samples will be collected from fracture patients     to be genotyped for purinergic receptor SNPs and analyzed for biochemical markers of bone     turnover. Systemic correlates of osteoporosis will be compared between osteoporotic subjects     (i.e. low BMD) and non-osteoporotic controls (i.e. normal to high BMD). Subsequently, whole     blood assays in patient subgroups (n=20 per subgroup), based on BMD and purinergic receptor     SNPs, will be performed to evaluate ex vivo effects of ATP and related nucleotides bone     markers.      Study population: Patients of 50 years and older attending an outpatient osteoporosis clinic     at the Maastricht University Medical Center for standard medical follow-up after a clinical,     non-pathological fracture.      Primary outcome parameters: BMD and purinergic receptor SNPs.      Secondary outcome parameters: Bone markers.   "
217259|NCT00697996|"     Rituximab will be tested for its safety and potential efficacy in treating B cell dense renal     allograft rejection episodes in children receiving renal transplants at Stanford University   "
217317|NCT00698789|"     Determine the effect of treatment with INCB019602 administered as an add-on to stable dose     metformin therapy in type 2 diabetic subjects on safety and glycemic control.   "
217260|NCT00698009|"     Primary:      Evaluate safety, feasibility, persistence, and anti-tumor effect of infused haploidentical     donor-derived natural killer (NK) cells and low-dose interleukin-2 (IL-2).      Secondary:        -  Quantification of cytokine levels;        -  Assessment of NK cell immunophenotype and function.   "
217261|NCT00698022|"     This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the     administration of risperidone alone or in combination with mifepristone in healthy adult male     volunteers to determine the average change in absolute weight at Day 28 compared to baseline.   "
217262|NCT00698035|"     The purpose of this clinical research study is to determine whether the ESTRING or a special     preparation of a testosterone cream inserted vaginally are safe for use in breast cancer     patients. This study will also evaluate if either of these treatments can improve symptoms of     vaginal dryness or decreased sexual interest that are related to your treatment for breast     cancer.   "
218932|NCT00716794|"     This is a phase I/II, open-label, dose escalation study of HE3235 administered orally to     patients with advanced prostate cancer who have failed hormone therapy and at least one     taxane based chemotherapy regimen.   "
217263|NCT00698048|"     Patients with severe infection can develop very low blood pressure. There are many mechanisms     leading to this, and one of them appears to involve a hormone called vasopressin. In children     as compared to adults, the mechanism and response to low blood pressure are different for     reasons that are not clear. One possibility is the difference in the production and/or     response to vasopressin. Vasopressin has become part of the treatment of children with low     blood pressure in the setting of severe infection, when other treatment has failed, but its     use is on the basis of animal and adult studies. The exact timing and dose is uncertain.      In this research study, the patients will receive standard treatment for sepsis and septic     shock, and the investigators will measure the blood levels of vasopressin and a related     compound called copeptin (both are required to understand the mechanism of control involved).     Blood will need to be taken from patients without any sepsis so as to be able to compare the     values in health and in sickness. The patient groups the investigators have chosen for this     are those children who will have blood taken anyway as part of their routine care. The aim of     this study is to develop an understanding of the body's hormonal response (with respect to     vasopressin) to severe infection in children. The long-term aim is to improve the care of     critically ill children with severe infection by using the most appropriate dose of     vasopressin at the most appropriate time.   "
217264|NCT00698061|"     Subjects who had not responded to previous hepatitis B vaccination were vaccinated with     either the adjuvanted HBV-MPL vaccine or Engerix™-B vaccine according to a three-dose     vaccination schedule (0, 1, 2 months) and boosted at Month 12 as per their group allocation.     The immunogenicity and safety of the HBV-MPL vaccine were compared with the control vaccine,     Engerix™-B.   "
217265|NCT00698074|"     The primary aim of this study will be to assess whether Biventricular pacing improves     exercise capacity, and Quality of Life in patients with symptomatic drug resistant     Non-Obstructive Hypertrophic Cardiomyopathy, using a Biventricular pacemaker.   "
217266|NCT00698087|"     The purpose of the study is to compare the safety, reactogenicity and immunogenicity of     different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B     when administered at 0, 2 months with a booster at month 12 if necessary   "
217267|NCT00698100|"     The overall goal of this study is to find out about the safety of injecting the genes (DNA)     for human and mouse tyrosinase in patients with melanoma. There is no evidence yet that     injection of tyrosinase DNA results in any clinical benefit. Tyrosinase is the substance     found in melanoma cells that helps to produce their black color. The DNA used in this study     was purified from bacteria which contains the gene for tyrosinase. DNA is material which     contains the information needed to produce many substances in the body.   "
217268|NCT00698113|"     The purpose of this study is to determine how parents of children with cancer rate a     parent-delivered massage therapy educational program for usability and satisfaction, and if     massage therapy, provided by parents to their child with cancer, reduce symptoms of anxiety     and depression in the child, and parenting stress in the parent.   "
217269|NCT00698126|"     This trial is conducted in Europe. The aim of this observational study is to evaluate the     incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with     NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.   "
217270|NCT00698139|"     Many patients with heart failure are unable to increase their heart rate appropriately when     their body needs increased blood flow. As a result, they may be unable to mobilize excess     fluid that their body retains. We hypothesize that we can provide assistance to their body in     mobilizing this fluid by artificially increasing their heart rate using a pacemaker. We plan     to conduct a prospective clinical trial to evaluate this hypothesis.      We will use a cross over design to study patients who already have biventricular pacemakers     implanted or a narrow QRS and volume overload. We will screen them using a blood test that is     a rough estimate of volume overload. Patients who meet the inclusion criteria will be     randomly assigned to have their pacemakers adjusted or to have no intervention during the     first of 2 visits. They will be unaware of which group they are in. Following adjustment,     they will be monitored for six hours.      Prior to the pacemaker adjustment, several tests will be performed to evaluate heart function     and the levels of hormones related that are affected by heart failure. These tests will be     repeated at the end of the six hour intervention period in each visit. At the end of the     visit patients who had their pacemakers adjusted will have it reset to their original     settings.   "
217271|NCT00698152|"     The purpose of this data collection is to determine long term survival rate of ArComXL®     highly cross-linked polyethylene   "
217272|NCT00698165|"     Objective of study is to assess the costs of care, objective and subjective caregiver burden     and quality of life in relation to disease severity measured by cognitive function, ADL     capabilities and presence of behavioral disturbances in Alzheimer's disease   "
217289|NCT00698412|"     Sixty four participants were enrolled in a randomized, controlled clinical trial to evaluate     the effectiveness of daily cane use on pain, function, quality of life and energy consumption     during the gait in patients with knee osteoarthritis.   "
217318|NCT00698802|"     This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose     control of biphasic human insulin 100 IU/mL and EX1000.   "
217273|NCT00698178|"     Gastroesophageal reflux disease (GERD) is a common and important disorder. Previous studies     have demonstrated the association of obesity with GERD, and now obesity is regarded as a risk     factor for GERD. Moreover, body mass index (BMI), an indicator of general obesity, correlates     with severity of symptoms and degree of erosive esophagitis. Waist circumference, an     indicator of abdominal obesity, has stronger correlation with intra-abdominal pressure and     low-grade inflammatory state when compared with BMI. Nevertheless the association of waist     circumference with severity of GERD has not been studied.      The primary aim of this study is to compare BMI with waist circumference for their     independent association with severity of GERD. The secondary aim is to evaluate independent     risk factors of severity of GERD.   "
217274|NCT00698191|"     This study will explore a new approach to treat patients with a medical condition known as     systemic lupus erythematosus (SLE) who have been resistant to previous treatments using a new     population of cells with capability to restore a normal immune system that will no longer     attack the body.      The stated hypothesis is that the SLE condition is caused by an abnormal immune system that     can be restored by replenishing the body with a new population of progenitor cells.   "
217275|NCT00698204|"     Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation     therapy given for treatment of head and neck cancer. These lesions are painful, compromise     nutrition and quality of life and may necessitate interruptions in radiation therapy, thus     adversely affecting cancer therapy outcomes. This study examined the use of an     anti-inflammatory medicine to reduce pain and severity of oral mucositis.   "
217277|NCT00698243|"     The primary objective of this study is to determine the maximum tolerated dose (MTD) and to     establish the recommended phase 2 dose of oral OSI-027 when administered via 3 schedules,     namely, intermittent, weekly, and continuous in patients with advanced solid tumors or     lymphoma, namely, intermittent, weekly, and continuous.   "
217278|NCT00698256|"     The aim was to investigate the effects of the consumption of high doses of plant stanol     esters on concentrations of serum lipids, carotenoids and fat soluble vitamins. In addition,     we investigated the metabolism of absorbed plant sterols from intestine without and with the     consumption of plant stanol esters.   "
217279|NCT00698269|"     This study is conducted in Asia. The aim of this observational study is to evaluate the     safety and efficacy of modern insulins after switch from any other anti-diabetic treatment     under normal clinical conditions in the Gulf countries.   "
217280|NCT00698282|"     The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in     healthy Japanese subjects   "
217281|NCT00698295|"     The purpose of this study is to evaluate clinical meaning of EEG changes in     antipsychotic-treated patients with schizophrenia.   "
217282|NCT00698321|"     This study will evaluate the effectiveness of a school-based HIV/sexually transmitted disease     prevention program in reducing sexual risk behaviors of youth attending school in Liberia.   "
217283|NCT00698334|"     Tuberculosis (TB) is the most common opportunistic infection among HIV infected persons     living in developing countries. Directly observed treatment, short-course (DOTS) is the     internationally recommended strategy for the treatment of TB. However, the efficacy of DOTS     for the treatment of HIV-associated TB is not well studied. This study aims to compare the     efficacy of thrice weekly DOTS in HIV-infected versus HIV-negative patients with TB.   "
217284|NCT00698347|"     The purpose of this prospective clinical data collection is to document the performance and     clinical outcomes of the M2a-Magnum™ Hip System   "
217285|NCT00698360|"     Rationale: Investigation of the circadian rhythm of erythropoietin and melatonin in patients     with various degrees of renal insufficiency      Objectives:      Primary objective: Is there a circadian rhythm of epo and melatonin in patients with various     degrees of renal insufficiency?      Primary Objective: Is there a circadian rhythm of epo and melatonin in patients with various     degrees of renal insufficiency compared to patients with a normal renal function?      Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various     degrees of renal insufficiency?      Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various     degrees of renal insufficiency compared to patients with a normal renal function?      Study design: Comparative study in 4 groups with various degrees of renal insufficiency,     duration for each patient 24 hrs. Total duration of study 12 months, patients admitted to the     hospital (on nursing ward)      Study population: Patients with various degrees of renal insufficiency      Main study parameters/endpoints: Analysis of the existence of a circadian rhythm in patients     with a normal renal function and in patients with variable degrees of renal insufficiency      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Better knowledge of the circadian rhythm in renal insufficiency. This could lead     to a more efficient administration of erythropoietin and melatonin in the future.      Extent of burden is 1 venapunction for placement of infusion needle, the withdrawal of 11     times 5 ml blood in 24 hrs, continuous measurement of body temperature via capsule, 24-hour     continuous ambulant blood pressure monitoring.   "
217286|NCT00698373|"     L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography     (PET). The aim of this study was to determine whether PET-CT with 18F-FMT provides additional     information for the preoperative diagnostic workup as compared with 18F-FDG PET. Tumor uptake     of 18F-FMT was compared with several immunohistochemical markers including L-type amino acid     transporter 1 (LAT1).   "
217287|NCT00698386|"     The primary objective of the study is to evaluate the efficacy of oral Zinc administration in     new smear positive pulmonary tuberculosis patients. Evidence is available suggesting that     zinc deficiency rapidly diminishes antibody- and cell-mediated immune responses in both     humans and animals and renders the individual susceptible to a variety of pathogens. This     micronutrient has also been found to be useful in the treatment of lung tuberculosis in     limited number of patients.      We are conducting this study in category-I patients (As per World Health Organization, Geneva     classification of tuberculosis) having lung tuberculosis to see the efficacy and also to see     any change in the immunological parameters.   "
217288|NCT00698399|"     This is an observational study examining serum markers in patients who are undergoing either     a cadaveric liver transplant or a living related liver transplant.   "
222615|NCT00768326|"     The main purpose with the study is to evaluate the efficacy and safety of Lu 31-130 in     patients suffering from schizophrenia compared to placebo.   "
217290|NCT00698425|"     The purpose of this study is to evaluate the safety and tolerability of a single     iontophoretic dose of buffered solution administered through the EyeGate® II Drug Delivery     System in healthy adult human volunteers.   "
217304|NCT00698607|"     Objectives        1. To evaluate the safety and long-term effectiveness of coronary stenting with the          Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa          Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting          coronary stent system(SECSS) (CypherTM, Cordis Johnson & Johnson, Warren, NJ) in the          treatment of coronary stenosis.        2. To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with          12-month clopidogrel therapy.      Study Design: Prospective, open label, two-arm, randomized multi-center trial to test the     non-inferiority of EECSS compared with the SECSS, and to test the non-inferiority of 6 months     duration compared with 12 months duration of clopidogrel therapy. Patients will be randomized     in a two by two factorial manner according to the type of drug eluting stent (EECSS vs.     SECSS) and the duration of dual anti-platelet therapy (6 months vs. 12 months). Randomization     will also be stratified per hospital for the presence of DM and the presence of long lesions     (lesion length ≥ 28mm)      Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea.      Patient Follow-Up: Clinical follow-up will occur at 1, 3, and 9 months, and at 1, 2, 3, 4,     and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office     visits.      Primary Endpoint        -  In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs.          SECSS.        -  Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven          target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months          of clopidogrel therapy      Secondary Endpoint        -  All Death        -  Cardiac death        -  Myocardial infarction        -  Target vessel revascularization (TVR) (all and ischemia-driven)        -  Target lesion revascularization (TLR) (all and ischemia-driven)        -  Stent thrombosis        -  Acute success (device, lesion, and procedure)        -  Bleeding        -  Cerebrovascular accident        -  In-stent LL at 9 months        -  Angiographic pattern of restenosis at 9-month angiographic follow-up        -  In-stent and in-segment % diameter stenosis (%DS) at 9 months        -  In-stent % volume obstruction (%VO) at 9 months        -  Incomplete stent apposition post index procedure        -  Persisting incomplete stent apposition, late-acquired incomplete stent apposition,          aneurysm, thrombosis, and persisting dissection at 9 months   "
217291|NCT00698438|"     the purpose of this study was to compare standard trabeculectomy to the Ex-PRESS mini     glaucoma shunt implantation under a scleral flap in eyes with open-angle glaucoma.In this     report, we describe the results of a prospective, randomized trial in which subjects with     bilateral primary open-angle glaucoma underwent the two procedures in fellow eyes.Design:     Prospective, randomized clinical trial.      Participants: 15 subjects with bilateral primary open-angle glaucoma Methods: Subjects     underwent the two procedures in fellow eyes. Safety and efficacy were evaluated for up to two     years.      Main Outcome Measures: Mean IOP and surgical success rates. Results: Mean IOP was similar in     Ex-PRESS and trabeculectomy eyes at all time points except month 9, when Ex-PRESS eyes had     lower mean IOP (13.2 mmHg vs 16.5 mmHg, respectively; p=0.025). Percent IOP reduction was     also similar at all time points except postoperative day 1, when trabeculectomy eyes were     lower (75.5% vs 65.8%, respectively; p=0.003), likely due to a higher rate of early hypotony     in trabeculectomy eyes versus Ex-PRESS eyes (47% vs 7%, respectively). Complete (without     medications) and qualified (with or without medications) successes were more common at all     IOP cut-off values in Ex-PRESS eyes than trabeculectomy eyes at last visit (p=0.015, p=0.015     respectively). Postoperative complications were uncommon in both groups, but trabeculectomy     eyes required more postoperative interventions than Ex-PRESS eyes.   "
217292|NCT00698451|"     The purpose of this study is to evaluate the response rate (Complete Response (CR) and     Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in     patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal     cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten     28-day cycles. Patients will be followed for six months following treatment to assess     progression-free survival.   "
217293|NCT00698464|"     The purpose of this study is to evaluate the effect of varying degrees of hepatic function     (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in     subjects.   "
217294|NCT00698477|"     Primary Objectives        1. To identify hypermethylated genes in paired pretreatment breast tumor tissue and plasma          samples from locally advanced and metastatic breast cancer patients using a known gene          panel which includes APC1, Cyclin D2, RARB, RASSF1A, Twist, Hin1 and GSTP1.           Rationale: We and others have determined the optimal panel of genes that are able to          detect free DNA in plasma and serum. We will determine if the same panel of genes is          effective for detecting tumor DNA in the plasma of locally advanced and metastatic          breast cancer patients. Further, to determine if the methylation profile of the plasma          DNA for these genes is the same or different from the primary tumor at presentation, we          will analyze the primary tumor DNA from fresh frozen samples.        2. To identify methylation pattern changes in the same subset of patients' plasma samples          at 24 hours after completion of cycle 1 of chemotherapy and within 24 hours before cycle          2.      Rationale: The optimal timing of sampling for methylation analysis that is reflective of the     tumors response to chemotherapy is not known. How soon methylation changes are observed,     whether they are high within 24 hours, as that tumor responds to chemotherapy, or whether     changes can be observed only some time after one cycle of chemotherapy will be studied. (3)     To also identify methylation pattern changes in breast tumor tissue after one cycle of     chemotherapy.      Rationale: To look for a correlation with plasma methylation patterns      Secondary Objectives      (1) To correlate our observed patterns of methylation pre- and post-treatment with clinical     parameters such as clinical and/or radiological response and patient outcome.   "
217295|NCT00698490|"     The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive     subjects, the humoral and cellular immune response of herpes simplex candidate vaccines     containing gD from two different cell lines and using gD-Alum as control.   "
217296|NCT00698503|"     The purpose of this prospective clinical data collection is to document the performance and     clinical outcomes of the M2a- 38™ Hip System   "
217297|NCT00698516|"     Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both     endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will     increase delivery of topotecan to tumor cells and may enhance activity of topotecan in     patients with previously treated small cell lung cancer and improve progression free     survival.   "
217298|NCT00698529|"     This study will compare the effectiveness of face-to-face training versus Web-based training     seminars in disseminating HIV prevention interventions to nongovernmental organizations in     Eastern Europe and Central Asia.   "
217299|NCT00698542|"     The Patient Safety Screening Tool (PSST) for Sepsis solution is a tool to assist with the     early detection of Sepsis and management of the administration of bundle packages as defined     by the Institute for Healthcare Improvement (IHI). This web based application relies on     integration with bedside medical equipment (BME) data as well as Lab and Registration data so     that clinical workflow items can be automated in the fight against Sepsis.   "
217300|NCT00698555|"     This study will evaluate the immunogenicity and safety of different formulations of the     candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that     of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal     dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months   "
217301|NCT00698568|"     This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine     with adjuvant in initially HSV seropositive or seronegative subjects who have no genital     herpes disease.   "
217302|NCT00698581|"     Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited     number of AEDs are approved for use as monotherapy. The objective of this study is to     evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure     patients from combination treatment to monotherapy   "
217303|NCT00698594|"     The purpose of the trial is to compare the efficacy and safety of sublingual seasonal and     annual immunotherapy in children with allergic rhinitis allergic to grass pollens.   "
217305|NCT00698633|"     The purpose of this prospective clinical data collection is to document the performance and     clinical outcomes of the M2a- Taper™ Hip System   "
217306|NCT00698646|"     The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy     with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with     monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70     years) with stage 1 or 2 hypertension   "
217307|NCT00698659|"     1. To determine the effect of anti-vascular endothelial growth factor (VEGF) on endothelial          function and on retinal microvasculature        2. To determine endothelial dysfunction as a marker of early response and as an indicator          for the development of hypertension and proteinuria in patients treated with anti-VEGF          agents        3. To characterize the effect of anti-VEGF therapy on the pulmonary function of patients          with malignancy (primary or secondary) involving the lung   "
217308|NCT00698672|"     The purpose of this study is to compare wear and migration of the following hip prostheses:        1. Charnley monoblock 22.2mm caput and OGEE polyethylene acetabular component        2. Spectron EF stem with Reflection polyethylene cup and 28 mm CoCr caput        3. Spectron EF stem with XLPE cup and 28 mm CoCr caput        4. Spectron EF stem with Reflection polyethylene cup and 28 mm Oxinium caput        5. Spectron EF stem with XLPE cup and 28 mm Oxinium caput   "
217309|NCT00698685|"     This study tests the hypothesis that a purely immunosuppressive preparative regimen allows     engraftment of related or unrelated allogeneic hematopoietic stem cells in subjects with     high-risk malignancies, without causing the post-transplant myelosuppression (e.g.,     neutropenia, thrombocytopenia) that occurs with currently used reduced-intensity     (nonmyeloablative) preparative regimens. This study incorporates both safety and efficacy     endpoints and evaluates a novel preparative regimen of alemtuzumab plus continuous-infusion     pentostatin, two immunosuppressive agents with different mechanisms of action, in recipients     of related or unrelated allogeneic hematopoietic stem cell transplantation.   "
217310|NCT00698698|"     Diabetes mellitus is becoming a global epidemic. There is a need to devise a non invasive     method for detection of diabetes and its related complication. Tear proteins are easy to     collect causing no harm to a patient and different studies indicate that tear proteins of     diabetic patients are significantly different from non diabetic population. This difference     in the composition of tear proteins become more pronounced with advancement of diabetic     retinopathy.   "
217311|NCT00698711|"     The purpose of this research is to help us study a vaccine treatment for patients with     prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections     and other foreign substances. The immune system is made up of many different types of cells,     which fight infection and disease in your body. A vaccine may stimulate the immune system to     destroy the cancer cells. It may also help to slow the growth of the cancer. The vaccine is a     solution given as an injection given into or under the skin. It is made up of several parts.     The first part is MUC-2, a protein present in many cancers, especially prostate cancer. MUC-2     is attached to a material called KLH or keyhole limpet hemocyanin. KLH is purified from a     snail- like marine mollusk called a keyhole limpet and has been used for many years to boost     immune responses in animals and in people. Attaching MUC-2 to KLH helps the immune system     react to MUC-2. The mixture of MUC-2 attached to KLH is in turn mixed with a material called     QS21, from the bark of a tree, which also helps the immune system to make more cancer-     fighting cells. A vaccine like the one you will receive has been given to laboratory animals     and been shown to produce an immune response in these animals.   "
217312|NCT00698724|"     To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone     versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual     acuity and OCT measurements.   "
217313|NCT00698737|"     This research study takes place at Wayne State University and will take about 11 weeks to     complete. This is a treatment research study for individuals who currently have cocaine abuse     or dependence, and who may also have heroin dependence. The purpose of this study is to test     whether oral sustained release d-amphetamine (SR-AMP) is safe and more effective than placebo     for preventing relapse to cocaine use for individuals who abuse or are dependent upon     cocaine. We are also interested whether, for patients who are dependent on cocaine and     heroin, whether SR-AMP is safe and effective for preventing cocaine relapse in combination     with buprenorphine.   "
217314|NCT00698750|"     The purpose of this study is to perform a five-year, prospective evaluation of the Copeland™     Humeral Resurfacing Head Prosthesis for outcome and durability. Relief of pain and     restoration of function will determine long-term clinical outcome while durability will be     measured by the absence of revisions.   "
217315|NCT00698763|"     The primary objective is to explore the safety of low doses of oral levosimendan in patients     with recent history of an ischaemic cerebrovascular event (stroke or TIA). The main focus     will be on the evaluation of proarrhythmic potential of the different dose regimens.   "
217316|NCT00698776|"     This is a single arm open label trial to test the tolerability of the combination of monocyte     derived DCs loaded with KRN7000 (DC-KRN7000) and Lenalidomide (LEN) in patients with     asymptomatic myeloma. Phase I component of the study will evaluate the optimal dose of LEN,     with particular emphasis on safety. After an interim analysis of these data, a single dose     level will be chosen for phase II component in additional patients.   "
217319|NCT00698815|"     This randomized phase II trial studies pemetrexed disodium and sunitinib malate to compare     how well they work when given alone or together as second-line therapy in treating patients     with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as     pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow     to the tumor. It is not yet known whether pemetrexed disodium and sunitinib malate are more     effective when given alone or together in treating non-small cell lung cancer.   "
217320|NCT00698828|"     To evaluate SUN11031 for injection compared to placebo in subjects with cachexia associated     with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on physical     performance and body composition.   "
217321|NCT00698841|"     The purpose of this study is to determine whether corrected QT (QTc) interval changes occur     on an electrocardiogram (ECG) when cetuximab is administered to the study population.   "
217324|NCT00698880|"     Portal vein embolization (PVE) induces shrinkage of the embolized lobe and compensatory     enlargement of the non-embolized lobe, but it does not always induce sufficient liver     regeneration. There was no effective method to accelerate liver regeneration in addition to     PVE yet.      This study intends to assess the effect of ipsilateral hepatic vein embolization (HVE)     performed after Portal vein embolization (PVE) on liver regeneration. During a 1-year study     period, preoperative HVE would be performed on 10 or more patients who had shown limited     liver regeneration after PVE awaiting right hepatectomy. Sequential application of PVE and     HVE may be safe and effective in facilitating contralateral liver regeneration by inducing     more severe liver damage than PVE alone.   "
217325|NCT00698893|"     The purpose of the study is to evaluate the safety and reactogenicity of candidate gD     vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in     these subjects will also be evaluated.   "
217326|NCT00698906|"     This study will evaluate the immunogenicity and safety of different formulations of the     HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of     Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose     of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months   "
217327|NCT00698919|"     Sepsis is a common cause of morbidity and death in intensive care units. Clinical and     laboratory signs of systemic inflammation, including changes in body temperature,     tachycardia, or leukocytosis, are neither sensitive nor specific enough for the diagnosis of     sepsis. The diagnosis of sepsis is difficult, because clinical signs are unspecific. These     signs include tachycardia, leucocytosis, tachypnoea, and pyrexia, which are collectively     termed a systemic inflammatory response syndrome (SIRS). SIRS is very common in critically     ill patients, being found in various conditions including trauma, surgery, burns,     pancreatitis, post-cardiac arrest syndrome, cardiac surgery. Microbiological culture can be     used to distinguish sepsis from non-infectious conditions. However, this method lacks     sensitivity and specificity, and there is often a substantial time delay. So these signs can     also be misleading because critically ill patients often present with the systemic     inflammatory response syndrome without infection. This issue is of paramount importance,     since therapy and outcome differ greatly between patients with and those without sepsis;     clinicians are often prone to overuse antibiotic therapy being afraid of not treating a     potential infection or superinfection. Moreover, the widespread use of antibiotics for all     such patients is likely to increase antibiotic resistance, toxicity, and costs. On the     opposite, any delay in administration of antibiotics can be extremely detrimental for the     infected patient with an exponential increase of the odd ratio for death. Search for early     biomarker tools for the diagnosis of infection, initially promising, are quite challenged and     controversial nowadays because they can be more related to the inflammation response,     irrespective to the insult. Furthermore up to 40% of the infections remain strongly suspected     but not bacteriologically documented. Persisting researches are ongoing to find new markers     to better discriminate SIRS related to infection process from to SIRS not related to     infection. Cytokine profiles using multiplex analysis seems more related to the severity of     the SIRS than the trigger of the SIRS (infectious or non infectious diseases). Thus, new     tools have been developed to identify bacteria by detecting their DNA by various techniques.     These techniques have many potential interests over conventional microbiologic tests by     decreasing turnaround time (within a few hours 2-6 hours), reducing inhibitory effects of     prior use of antibiotics, detection of slow or fastidious growing organisms. However these     tests remain to be validated in a clinical setting.      The goal of the current study is to evaluate the diagnostic value of plasma detection of     bacterial DNA in ICU patients with a clinical suspicion of bacterial infection.   "
217328|NCT00698932|"     Saxagliptin is a new investigational medication being developed for treatment of type 2     diabetes. This study is designed to evaluate the efficacy and safety in adult patients with     inadequate glycaemic control with diet and exercise.   "
217329|NCT00698945|"     To assess the additional benefit of common adjunctive classes on the diurnal IOP curve in     patients assessed as needing additional treatment to reach target intraocular pressure (IOP).     To demonstrate superiority of IOP control with Istalol 0.5% QD compared to Brimonidine     Tartrate 0.2% BID as adjunctive therapy in adults with uncontrolled IOP's (determined by P.I.     based on target pressures) currently treated with Latanoprost 0.05% in the study eye(s).   "
217330|NCT00698958|"     A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive     mechanical ventilation in patient with hypercapnic respiratory failure secondary to     neuromuscular diseases or alterations in thoracic cage in comparison with hospital     adaptation.   "
217331|NCT00698984|"     The purpose of this study is to obtain information about the effect of a combination of     genistein, PUFAs, vitamin K and D (BONISTEIN(R) bone blend) on bone health, determined as     bone mass density/content and bone biomarkers after 6-months treatment in 70 healthy     postmenopausal women. In addition, safety and tolerability will be investigated.   "
217332|NCT00698997|"     Goals of the current project: (1) Does the Early Start Denver Model experimental intervention     for toddlers with autism reduce disability associated with autism significantly more than     standard community interventions?; and (2) What environmental, child, and biological     characteristics mediate and moderate intervention response and outcomes at age 4?   "
217333|NCT00699010|"     The purpose of this study is: (1) to assess the effect of oxycodone HCl on niacin-induced     dysphoric effects when oxycodone HCl is administered in combination with niacin in subjects     with a history of opioid abuse; (2) to assess the abuse liability of 4 times the usual     recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40     mg alone in subjects with a history of opioid abuse.   "
217334|NCT00699023|"     The purpose of this study is to determine whether ezetimibe in association with statins is     more effective than statins alone on postprandial lipemia in type 2 diabetic patients.   "
217348|NCT00688987|"     Replacing glucocorticoid in a dose dependent manner (including doses within the physiological     range) to subjects with adrenal insufficiency will increase visceral fat accumulation     independently of total fat mass.   "
217335|NCT00699036|"     The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with     rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven     nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are     there differences in the efficacy (as measured by histopathology and insulin resistance) of     three different therapeutic modalities used to treat NASH?   "
217336|NCT00699049|"     The purpose of this study is to explore additional benefit of solifenacin after 12-week     treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.   "
217351|NCT00689026|"     A large population-based study has shown diabetes to be an independent risk factor for colon     cancer compared to the general population. Thus, the completion of an adequately prepped     colonoscopy is requisite in providing diabetics with adequate colon cancer screening.      Recent data has shown that diabetic patients have poorer response to bowel cleansing compared     to non-diabetics (with a standard PEG prep, only 62% of diabetic patients had their     colonoscopy preps rated as good or better vs. 97% of normal patients, p<0.001). This may be     due to the fact that a majority of diabetic patients report constipation as a common     gastrointestinal complaint.      We postulate that lubiprostone (Amitiza), in combination with PEG, will have additional     efficacy over standard PEG preparation, and provide optimal safe and effective colonic     cleansing for diabetics.   "
217337|NCT00688844|"     HYPOTHESIS: The investigators hypothesize that KuvanTM therapy could influence nutritional     and body composition parameters and neurotransmitter concentrations in pediatric and adult     PKU subjects.      SUMMARY: Though the investigators know that KuvanTM lowers blood Phe levels and improves     tolerance for natural protein in at least half of the PKU (Phenylketonuria) patient     population, investigators do not know the full effects this medicine will have on the     patient's diet, or what impact the medicine or diet changes will have on the body composition     or nutrient status of PKU patients. Since KuvanTM may also help the body produce     neurotransmitters, investigators also want to find out if taking KuvanTM changes     neurotransmitter levels in PKU patients, and if PKU patients who are benefitting from KuvanTM     feel less stigmatized and have a better outlook on life as a result of the treatment.      Therefore, the research study has several objectives. These are to investigate the impact     KuvanTM therapy has on (1) body composition parameters of PKU patients: such as lean body     mass, percent body fat, bone density, weight gain, and growth (2) dietary changes, and the     effect of those changes, on intake of calories and essential nutrients (3) changes in blood     biomarkers of certain nutrients (4) blood and urine neurotransmitter levels, since these     changes could indicate improved neurological functioning, (5) and quality of life of PKU     patients, who may feel less burdened due to the dietary freedom KuvanTM provides.   "
217338|NCT00688857|"     This is a single-center, randomized, open-label, multi-dose crossover study assessing the     pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy     volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of     diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy     volunteers under fed conditions. Secondary objectives are to assess diazoxide choline     pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and     tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets     in healthy volunteers.   "
217339|NCT00688870|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of a     13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal     conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan.   "
217340|NCT00688883|"     To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.   "
217341|NCT00688896|"     The purpose of this study is to evaluate the effect of two dose levels of JTT-705 when     co-administered with pravastatin 40 mg on HDL-C and LDL-C and the inhibition rate of CETP     activity and to document short term safety.   "
217342|NCT00688909|"     This study will evaluate whether patients who are intolerant and discontinue anastrozole due     to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking     letrozole   "
217343|NCT00688922|"     The purpose of the Study is to determine whether early treatment with pravastatin can reduce     adverse cardiac events in patients with acute myocardial infarction and minimally to mildly     elevated serum Low Density Lipoprotein -Cholesterol (LDL-C) levels.   "
217344|NCT00688935|"     The primary goal of this study is to identify the presence of desynchronized circadian     rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples,     and to rule out any primary sleep disorders.   "
217345|NCT00688948|"     Multiple Sclerosis is often associated with severe functional deficits resulting in a range     of progressive impairments. Approximately 80% of patients have bladder symptoms at the time     of diagnosis and up to 97% will have bladder symptoms during the course of the disease. To     date, the vast majority of treatment has been centered on the use of medications to control     bladder spasms and the use of catheters to help patients empty the bladder. There have been     very few studies looking at medications like Alfuzosin that may help in controlling bladder     symptoms in Multiple Sclerosis. Alfuzosin has been shown to significantly improve voiding     symptoms and bladder emptying in patients with prostatic enlargement. There have been no     controlled studies yet to determine whether this treatment helps patients with Multiple     Sclerosis. The purpose of this study is to determine if Alfuzosin improves bladder symptoms     and quality of life in patients with Multiple Sclerosis.   "
217346|NCT00688961|"     Omacor (now Lovaza) is a pharmaceutical omega-3 fatty acid product. Omega-3 fatty acids can     affect blood clotting by altering the function of the blood platelets. Aspirin can do the     same. The purpose of this study is to determine the individual and combined effects of these     two agents on platelet function using a whole blood method.   "
217347|NCT00688974|"     Wight loss surgery provides good glycemic control in type 2 diabetes. The technique of     Roux-en-Y gastric bypass is more effective than the Adjustable Gastric Band on weight     loss.      This longitudinal cohort study will compare the effectiveness of the Roux-en-Y gastric bypass     and Adjustable Gastric Banding on glycemic control in type 2 diabetes and explore the     responsible mechanisms.      The evaluation will be made preoperatively and 1 year later as assessed by the decline in     HbA1c. An evaluation will also be carried out after a weight loss of 10% to indicate whether     the observed difference is independent of weight loss.   "
217349|NCT00689000|"     This is an open-label, non-randomised, multi-centre phase I-II study of CHR-2797 administered     orally once a day. The study involves two distinct phases:        -  Phase I: an open-label, dose-escalating phase of the study to explore the safety,          tolerability, and pharmacokinetics (PK) of CHR-2797.        -  Phase II: the recommended dose level of CHR-2797, as determined in phase I, will be          administered to a further cohort of approximately 40 patients to determine whether          CHR-2797 has sufficient biological activity against the disease(s) under study.   "
217350|NCT00689013|"     The purpose of this study is to determine whether pharmacist-driven patient interventions can     have an effect on the number of herpes zoster (Zostavax) vaccinations given in a community     pharmacy setting.   "
217352|NCT00689039|"     The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how     the medication is metabolised by the body (how it is taken up, distributed, and how it     disappears from the body). The study is performed in healthy volunteers.   "
219906|NCT00731601|"     A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators     hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.   "
217353|NCT00689052|"     The primary objective of this study is to assess the efficacy and safety of an     extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment     of fibromyalgia.      The objective of the open-label phase is to assess the safety profile and effect of     Pramipexole (PPX) extended-release (ER) in fibromyalgia patients over a 24-week period.   "
217354|NCT00689065|"     Rationale: CALAA-01 is a targeted therapeutic designed to inhibit tumor growth and/or reduce     tumor size. The active ingredient in CALAA-01 is a small interfering RNA (siRNA). This siRNA     inhibits tumor growth via RNA interference to reduce expression of the M2 subunit of     ribonucleotide reductase (R2). The CALAA-01 siRNA is protected from nuclease degradation     within a stabilized nanoparticle targeted to tumor cells.      PURPOSE: This phase I trial will:        -  Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CALAA-01 when          administered intravenously to patients with relapsed or refractory cancer.        -  Characterize the pharmacokinetics (PK) of CALAA-01 after intravenous administration.        -  Provide preliminary evidence of efficacy of intravenous CALAA-01 by evaluating tumor          response.        -  Recommend a dose of intravenous CALAA-01 for future clinical studies.        -  Evaluate immune response, by measuring antibody and cytokine levels, and the effect of          intravenous CALAA-01 on complement.   "
217355|NCT00689078|"     The purpose of the study is to determine whether prednisolone acetate 1% ophthalmic     suspension is effective in preventing signs and symptoms of allergic conjunctivitis in     comparison with prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2%     ophthalmic suspension and placebo in a modified conjunctival allergen challenge (CAC) model.   "
217356|NCT00689091|"     Awareness during anesthesia is a problem receiving increased attention by patients,     clinicians, and the general public. The incidence of intraoperative awareness has been     reported to be between 1-2/1000 cases, but recent data suggest that this may be an     overestimate. The Bispectral Index (BIS) Monitor is an electroencephalographic method of     assessing depth of anesthesia that has been shown in one study to reduce the incidence of     awareness during anesthesia in the high-risk population (Myles et al, 2004). In the study of     Myles et al, the number needed to treat (NNT) in order to prevent one case of awareness in     the high-risk population was 138, with an associated cost of approximately US$2200. Since the     NNT and the associated cost of treatment would be much higher in the general population, the     efficacy of the BIS monitor in preventing awareness in all anesthetized patients needs to be     clearly established. Furthermore, recent data suggest that the BIS may not be useful in the     high-risk population. The investigators propose a prospective, randomized, controlled trial     comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of     anesthetic depth.   "
217357|NCT00689104|"     The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron     against placebo and compare the efficacy and safety with active comparator in patients with     symptoms of overactive bladder.   "
217358|NCT00689117|"     The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in     subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel,     Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.   "
217359|NCT00689130|"     The present study is designed to compare prospectively whether sBIS, sEMG, or CVI variability     (brain monitoring) can be used to predict unwanted intraoperative responses (high blood     pressure, fast heart rate, tearing, etc.) to stimulation (pain) and to determine whether     these intraoperative findings are related to patient-assessed postoperative pain scores.      The hypothesis is that increases in these variability measures are associated with increased     probability of unwanted responses. If confirmed, these variability measures may help     anesthesia providers by highlighting periods of inadequate analgesia (pain relief).   "
217360|NCT00689143|"     This exploratory study is the first study in a clinical program where the overall objective     is to develop a novel pharmaceutical therapy comprising local administration of GM-CSF for     the treatment of periodontitis. The project hypothesis is based on GM-CSF's antibacterial and     putative bone regeneration properties. Periodontitis is the major cause of tooth loss in     people over 35 years of age. An effective pharmacological treatment is today lacking and the     actual therapy would represent a new treatment option for the large patient group suffering     from the disease.   "
217361|NCT00689156|"     The Danish Breast Cancer Cooperative Group (DBCG) wishes to clarify if recurrence-free and     overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin     and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast     cancer.   "
217362|NCT00689169|"     The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen     utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined     with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to     65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma   "
217376|NCT00689351|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of a     13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal     conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.   "
217363|NCT00689182|"     Hypothesis: The reduction of total body iron by phlebotomy will be safe and feasible in the     post-HSCT setting      Iron overload is common after hematopoietic stem cell transplantation. It is associated with     chronic liver disease, with increased rates of infection and decreased survival.      Eligible, consenting patients will have once monthly phlebotomy procedures (500ml) for 12     months.      SAFETY: At each visit, patients will have a comprehensive assessment prior to starting and     after completing the phlebotomy. This assessment will include determination of pain at     phlebotomy site, local infection and an assessment of symptoms of anemia including     presyncope, fatigue and dyspnea. The patient's pulse, blood pressure, respiratory rate and     temperature will also be determined before and following the phlebotomy.      EFFICACY: Iron stores will be measured serially in each patient. Measurements will be     performed prior to the start of phlebotomy, and at 6 months and 12 months following the start     of the series of 12 phlebotomies. These evaluations will be undertaken regardless of the     number of phlebotomies which the patient actually undergoes. Iron stores will be estimated by     measuring serum ferritin and transferrin saturation levels. Total body iron will be estimated     from hepatic and cardiac iron concentration as measured by magnetic resonance imaging (MRI).     Gandon et al. (12) described a non-invasive technique using MRI to measure hepatic iron     stores. Iron is a paramagnetic substance which causes local magnetic field inhomogeneities     leading to dephasing and signal loss in MRI. Gradient echo sequences are most susceptible to     their effects because they do not use a 180° refocusing pulse, unlike conventional spin-echo     sequences. Gandon et al. used multiple gradient echo sequences, compared the signal in liver     to adjacent muscle and used this ratio to correlate with hepatic iron levels measured on     tissue biopsy samples using spectrophotometric analysis. Multiple sequences were used because     the nomogram comparing the L/M signal ratio is linear over only a small concentration of     tissue iron.   "
217509|NCT00700804|"     The primary objective is to determine whether meat interacts positively with calcium to     improve calcium retention. The secondary objective is to determine whether any interaction     between dietary protein and calcium affects biomarkers of bone metabolism.   "
217364|NCT00689195|"     Curcumin as well as the ashwagandha extract are ingredients from traditional indian medicine     and have been shown to be potent anti-cancer compounds in laboratory as well as animal     studies. This study will test the safety and efficacy of a curcumin formulation and the     ashwagandha extract in high grade relapsed or metastatic osteosarcoma where no other second     line chemotherapy is being given. The pharmacokinetics will be studied along with response as     measured on CT scans and PET scans as well as the quality of life and any toxicity.   "
217365|NCT00689208|"     The present study on pharmacological intervention in autonomic nervous     dysregulation(parasympathetic dysfunction,) regarding insulin resistance, is a concept     testing in humans tohelp identify potential new pharmacological target sites in the central     nervous system.   "
217366|NCT00689221|"     CENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational     integrin inhibitor, cilengitide, in combination with standard treatment versus standard     treatment alone in newly diagnosed glioblastoma subjects with a methylated     O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor     tissue.      The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling     element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be     a predictive marker for benefit from temozolomide (TMZ) treatment.   "
217367|NCT00689234|"     The purpose of the study is to investigate the impact of unilateral or bilateral diaphragm     plication in a prospective randomised controlled way on symptoms, pulmonary function     including gas exchange, respiratory muscle strength, exercise capacity and breathing during     sleep in patients with proven uni- or bilateral phrenic nerve paralysis present for at least     1 year without any evidence of spontaneous recovery.   "
217368|NCT00689247|"     The purpose of this study is to learn more about how AZD1305 is handled by the body, i.e the     absorption, distribution, metabolism and excretion of AZD1305.   "
217369|NCT00689260|"     This study will help to determine whether an injection log on a recombinant human growth     hormone (rhGH) delivery device improves subjects' adherence with injection schedules.     Adherence will be compared between a group of subjects who are aware of the injection log on     the easypod™ rhGH delivery device and a group of subjects who are not aware of the easypod™     injection log. It is the study hypothesis that subject non-adherence rate is different for     those who are aware of the injection log capability versus those who are unaware of the     injection log capability. Subject perception will also be evaluated by comparing the ease and     convenience of use and subject preference for the easypod™ compared to two other rhGH pen     injection devices.   "
217370|NCT00689273|"     To evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics in     patients with osteoarthritic pain of the knee. The most painful knee joint will be identified     as the index joint at screening, and this joint will be used for all pain assessments     throughout the study.   "
217371|NCT00689286|"     Osteoarthritic changes in the knee are a common cause of pain that restricts the subject's     ability to move and may lead to surgical intervention with total knee replacement. Quadriceps     muscle strengthening has been shown to improve the dynamic stability of the knee, decreasing     pain during locomotion and increasing knee function. However, the gains associated with     improved quadriceps strength have been difficult to achieve on a routine clinical basis     because the currently available ways to increase muscle strength- through voluntary exercise     or surface electrical stimulation- have significant practical problems that limit their use.     The aim of this prospective study is to evaluate the safety and effectiveness of     neuromuscular stimulation using implantable microstimulators called BIONs to improve the     strength, range of motion, and health of the knee in patients with knee osteoarthritis. This     investigation is expected to last 12 weeks for each study participant; the trial will be     completed over a 3-year period. Patients recruited into the study will have advanced knee     osteoarthritis for which total knee replacement surgery is being considered. The proposed     study extends a feasibility study carried out in Milan, Italy on five patients with knee     osteoarthritis, who were implanted with BIONs.   "
217372|NCT00689299|"     The purpose of this study is to identify an effective dose of allergen-specific immunotherapy     for cat hair (Felis domesticus) administered by the oral/sublingual route.   "
217373|NCT00689312|"     The primary objective of this study is to compare the mean taste scores for three fruit     flavored oral rehydration solutions in children aged 5-10 years old. The secondary objective     is to compare the proportions of children who indicate a taste preference for one of the     solutions.   "
217374|NCT00689325|"     To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with     atypical antipsychotics.   "
217375|NCT00689338|"     To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal     infections in intensive care and critical care unit patients.   "
217377|NCT00689364|"     Comprehensive therapy of traditional Chinese medicine (CTTCM) could relieve risk of     recurrence and metastasis for stage II & III colorectal cancer, the investigators take this     clinical trial with retrospective-prospective cohort study based on previous studies by     international multi-center way.      If the study shows a positive result, a pragmatic randomized controlled study with     prospective, multi-centre and large-sample design will be given continuously. The aim is to     establish recommended programs suggested by CTTCM strategies under conventional Western     medicine therapy (CWMT) for stage II & III colorectal cancer.   "
217378|NCT00689377|"     Non interventional study aimed to establish the prevalence of lower extremity peripheral     arterial disease (PAD), defined as an ankle-brachial index (ABI) not above 0.90 in subjects     with a moderate risk of cardiovascular disease, with no overt cardiovascular diseases nor     diabetes mellitus.   "
217401|NCT00699192|"     To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80     mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and     amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential     hypertension. All three regimens are expected to be well tolerated.   "
217379|NCT00689390|"     Study P05063 is a 3-year long-term follow-up (LTFU) study in participants previously treated     with boceprevir (BOC) or narlaprevir (NAR) in a Phase 1, 2, or 3 clinical study. Participants     will be followed for up to 3.5 years after the end of their participation in the treatment     protocol to document maintenance of the antiviral response (for sustained responders) and to     characterize the long-term safety after use of this therapeutic regimen. LTFU procedures     include collection of plasma samples for measuring Hepatitis C Virus ribonucleic acid     (HCV-RNA) by polymerase chain reaction (PCR) and HCV sequence analysis. No drug therapy will     be administered as part of this study.   "
217380|NCT00689403|"     To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.   "
217381|NCT00689416|"     The primary aim of this study is to investigate the effect of 40 mg dose of rosuvastatin on     carotid plaque inflammation measured with MRI and PET scanning, to evaluate whether these     techniques are promising for future proof of principle studies. A number of patients will     receive placebo as a control.   "
217382|NCT00689429|"     A chart review will be performed to extrapolate information including sex, height, weight,     date/time admitted to HMC, injury data, comorbidities, fracture pattern, antibiotic usage,     surgical history, wound history, fracture healing, and length of time to return to work.     Dr.'s Goodspeed and Reid will conduct a radiographic review independently for each subject,     classifying all fractures according to the Orthopaedic Trauma Association classification     guide. If a discrepancy in classification is found, then both will discuss together and come     to a consensus.   "
217383|NCT00689442|"     The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of     JTT-705 compared with placebo when co-administered with atorvastatin 20 mg in patients with     low HDL   "
217384|NCT00689455|"     The aim of the study, is to assess the prevalence of Metabolic Syndrome in Italy on a     regional basis, defined according to NCEP/ATPIII Guidelines criteria.   "
217385|NCT00689468|"     This study was designed to evaluate the efficacy of the herb Echinacea purpurea and of     cranial osteopathic manipulative treatment to prevent otitis media (middle ear infections) in     young children.   "
217386|NCT00689481|"     The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with     plaque-type psoriasis.   "
217387|NCT00689494|"     Measure blood progesterone by using cervical device contraception.   "
217388|NCT00689507|"     H9S-MC-JDCF was a multicenter non-randomized, single-arm, open-label, dose-escalation, dose     confirmation, Phase 1 study of intravenous (IV) LY2127399 in combination with bortezomib in     patients with refractory or relapsed MM.   "
217389|NCT00689520|"     The purpose of this study is to evaluate whether low-molecular-weight heparin could be     equally or more effective than oral anticoagulation in the long-term treatment of deep venous     thrombosis.   "
217390|NCT00689533|"     Primary Objective: To evaluate the use of unilateral or bilateral VEPTR devices, with or     without expansion thoracoplasty, for preventing further progression of the Cobb angle,     allowing for spinal growth and improving pulmonary function in the treatment of children with     progressive scoliosis without rib abnormalities.   "
217391|NCT00689546|"     It has been observed that several of patients having prolonged or complicated course of acute     viral hepatitis have underlying diabetes. It is possible that with impaired hepatocyte     regenerating capacity, these patients run a more prolonged and complicated course.      We hypothesize that acute hepatitis infection has a prolonged and complicated course among     diabetic patients.   "
217392|NCT00699062|"     The distal lung contributes to asthmatic airway remodeling which is observed from early onset     of the disease. Cysteinyl leukotrienes (CysLT) play important role in the pathogenesis of     airway remodeling and antileukotrienes work to exert a certain degree of anti-inflammatory     effect. The cysteinyl leukotriene antagonist Montelukast has been in vivo shown to     significantly inhibit ovalbumin induced airway smooth muscle hyperplasia and subepithelial     fibrosis in sensitized mice. This study aims to evaluate if Montelukast could reverse airway     remodeling in asthma patients by a non-invasive approach-HRCT.   "
217393|NCT00699088|"     The purpose of this prospective clinical data-collection is to document the performance and     clinical outcomes of the Balance® Microplasty™ Hip System.   "
217394|NCT00699101|"     This multiple site, prospective, non-randomized study has been designed to compile     information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected     patients through evaluation of dosimetric success as compared with a single central lumen     balloon device and through treatment outcomes.   "
217395|NCT00699114|"     The purpose of this placebo controlled clinical trial is to evaluate the dose response     relationship of ibuprofen in doses from 400 mg to 800 mg and paracetamol (acetaminophen)in     doses from 500 mg to 1000 mg compared with paracetamol (acetaminophen)1000 mg plus codeine 60     mg on acute postoperative pain after surgical removal of impacted third molars.   "
217427|NCT00699738|"     This study will evaluate the physiological and pathophysiological determinants of pregnancy     and feeding method on the maternal cardiovascular system. This includes non-invasive     measurements.   "
217396|NCT00699127|"     Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of     questions, and look for information all the time. Organizing the information given to parents     could reduce their anxiety. The parents will be divided into two groups: one group will get     organized information, by a lecture at the first week of their infant's life, and the other     group will not. Of course, questions will be answered all the time. The parents will answer a     questionnaire on the first week of the infant's life, and on the last week, just before     releasing the infant home.   "
217397|NCT00699140|"     The purpose of this study is to determine whether IGIV3I Grifols 10% is effective in the     treatment of immune thrombocytopenic purpura.   "
217398|NCT00699153|"     Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic     base, when compared to vehicle for the treatment of inflammation following cataract surgery.   "
217399|NCT00699166|"     This study will evaluate the tolerability, safety and efficacy of DNK333 against diarrhea     caused by Irritable Bowel Syndrome in women.   "
217400|NCT00699179|"     This study is conducted in Europe. This observational study is aimed to reflect the     post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used     under normal clinical practice conditions in Serbia.   "
217437|NCT00699868|"     This prospective study evaluate the immune status of patients admitted in ICU.CMV remains     dormant in the body, but in people with immune deficiency, CMV could reactivate and cause     life-threatening pneumonia.   "
217402|NCT00699218|"     This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will     benefit patients with bipolar depression safely. Based on published studies, this study     hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some     patients who have failed at least two medications.   "
217403|NCT00699231|"     This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an     MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in     haemodialysis patients with or without previous vaccination against hepatitis B   "
217404|NCT00699244|"     Does ultrasound increases the success rate and if there is a difference in success rate     between placing the local anesthetic centrally versus peripherally.   "
217405|NCT00699257|"     The purpose of this prospective data collection is to document the performance and clinical     outcomes of the Oxford® Partial Knee System.   "
217406|NCT00699270|"     The purpose of this prospective clinical data collection is to document the performance and     clinical outcomes of Biomet Humeral Stems   "
217407|NCT00699283|"     Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited     number of AEDs are approved for use as monotherapy. The objective of this study is to     evaluate the efficacy of BRV in the conversion of partial onset seizure patients from     combination treatment to monotherapy.   "
217408|NCT00699296|"     This study will assess the safety, efficacy and pharmacokinetics of oral LBH589 in Japanese     adult patients with refractory cutaneous T-Cell Lymphoma and adult T-cell leukemia/lymphoma.     LBH589 is administered orally once a day for three days per week.   "
217409|NCT00699309|"     The purpose of this prospective clinical data-collection is to document the performance and     clinical outcomes of the Taperloc® Microplasty™ Hip System.   "
217410|NCT00699322|"     This research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and     improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in     type 2 diabetic patients with inadequate glycemic control on metformin   "
217411|NCT00699335|"     The aim of the study was to evaluate the efficacy and safety of Matrifen® in patients with     severe and chronic pain who could only be sufficiently treated with opioid analgetics (WHO     class 3).   "
217412|NCT00699348|"     This single arm study will assess the efficacy, safety and tolerability of once-monthly     administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the     maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia.     Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will     receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on     the erythropoietin stimulating agent [ESA] dose administered on week -1). Subsequent doses     will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per     deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample     size is 100-500 individuals.   "
217413|NCT00699361|"     Recently literature revealed facts, that show H+/K+ ATPase expression is not limited tot he     stomach. H+/K+ ATPase was also found in smooth muscle cells and in other tissues (McCabe,     R.D. et al., Am J Physiol. 1992). For myocard a localisation is only proven for rats yet     (Beisvag, V. et al., Acta Physiol Scand. 2003). Moreover biochemical hints lead us to a     highly probability of a myocardial H+/K+ ATPase (Nagashima, R. et al., Jpn Heart J. 1999).   "
217414|NCT00699374|"     The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally     once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients     with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A     and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be     given until disease progression, occurrence of unacceptable toxicity, or other withdrawal     criteria are met. After discontinuation of study treatment, patients will be followed up in     order to collect information on further antineoplastic therapy and survival.   "
217428|NCT00699751|"     ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical     study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone     refractory prostate cancer and skeletal metastases.   "
217429|NCT00699764|"     The purpose of the study is to evaluate the safety of Herpes Simplex candidate vaccine (gD2t)     with adjuvant and its efficacy to prevent genital herpes disease in HSV positive or negative     consorts of subjects with genital herpes disease.   "
217430|NCT00699777|"     This study is a randomized, open-label, crossover study to assess the bioequivalence of 1     risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral     dose. Approximately 320 subjects will be enrolled from 4 study centers in the U.S.   "
217431|NCT00699790|"     The purpose of the study is to determine whether a CCR2 antagonist (BMS-741672) improves     glucose homeostasis in drug-naive type 2 diabetic patients   "
217415|NCT00699387|"     Background: Chagas disease is a parasitic infection caused by the Trypanosome cruzi. The     initial phase of the infection happens mainly in children. Up to 10% of infected children     die. Survivors often develop chronic infection leading to heart disease and other     complications in 30% of patients. These complications often result in death or severe     handicaps in early adulthood, depriving societies of individuals in their most productive     years.      There are 20 million people infected in Latin America. Complications lead to 20,000 deaths     every year.      Treatment during the acute phase with benznidazole leads to a high cure rate. However, there     are very few studies of this drug and virtually none in children, even though benznidazole     was developed over 30 years ago.      Hypotheses and Specific Aims: We hypothesize that the pharmacokinetics of benznidazole in     children is different from adults, and that obtaining information on how it is absorbed,     distributed and eliminated in children will allow optimization of treatment of Chagas disease     in this population. This will in turn improve the outlook for children by reducing mortality     and long term complications. We aim to study the pharmacokinetics of benznidazole in children     receiving the drug for treatment of Chagas disease, and to correlate it with treatment     effectiveness and incidence of adverse effects.      Potential Impact: This novel knowledge will allow better and more rational approaches to the     treatment of Chagas disease. It will also set the foundation for further studies that will be     able to test improved therapies that may increase treatment response in vulnerable children.   "
217416|NCT00699400|"     Phase IV, prospective multicenter, observational Registry will track cycle outcomes for     subjects who are thawing frozen oocytes for subsequent use through in vitro fertilization     (IVF) and embryo transfer (ET)   "
217417|NCT00699413|"     The purpose of this study is to evaluate the effects of a combination of hydroxcycitrate     (HCA) and niacin-bound chromium, in conjunction with nutrition education, over a twelve week     period. Participants will be evaluated with regard to BMI, percent body fat, insulin     activity, and hunger.   "
217418|NCT00699608|"     This study will explore potential next-day residual effects of a single evening dose of 3mg     of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.   "
217438|NCT00699881|"     The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with     FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy   "
217439|NCT00699894|"     Postoperative nausea and vomiting (PONV) persists as one of the more common complications of     surgery. Although rarely life-threatening, it is the postoperative outcome that is most     unfavorable to patients, even more undesirable than pain. Orthognathic surgery corrects     conditions of the jaws and face related to structure, growth, sleep apnea, bad bite, or     congenital malformations. The bones of the face and jaws are cut and placed in a new     position. There is a high rate of PONV in orthognathic surgery (56%). It is particularly     challenging to the patient as their jaws are kept closed together with wires or elastic     bands. Nausea in a patient with restricted mouth opening can be psychologically unnerving and     puts them at risk for fluid in their lungs.      Gan and colleagues showed a higher efficacy of aprepitant over ondansetron in preventing PONV     and nausea severity after open abdominal surgery. From this study, the FDA approved the use     of aprepitant for PONV prevention in patients >18 years of age. Gan suggested further     investigation in different populations.      Our randomized, double-blind, prospective study will compare the efficacy of aprepitant PO     versus ondansetron IV in a high risk setting for PONV: adolescents undergoing orthognathic     surgery.      Our study will involve 200 consecutive, adolescent patients (ages 15-25) who will undergo at     least a Le Fort 1 osteotomy (upper jaw surgery) under general anesthesia and require hospital     admission for at least one night. We will exclude patients who are currently taking     medications that have interactions with aprepitant (pimozide, terfenadine, astemizole,     cisapride), those who have a known vomiting disorder such as bulimia, and those who have     vomited for any reason within 24 hours of surgery. The procedure will be performed by 5     surgeons and general anesthesia will be administered by 3 anesthesiologists at one     institution. A study coordinator, who will not be involved in the treatment, will create the     randomization schedule in order to ensure blindness. The patients will be randomized to     either of two groups: 1) aprepitant 40 mg PO 2) ondansetron 4 mg IV. Appropriate verbal and     written consent will be obtained by the priniciple investigator or surgeon.      On the day of the procedure, all patients will receive a pill (aprepitant or aprepitant     placebo) at least 1 hour prior to induction of anesthesia and an IV infusion (ondansetron or     saline) over 2-5 minutes prior to intubation. The timing and doses of medications will be     consistent with manufacturer's recommendations. An established protocol will ensure every     patient will receive the same anesthetic regiment. Patient's fluid status will be closely     monitored and hydrated appropriately according to known fluid balance calculations.      Efficacy will be assessed based on criteria set by Gan et al and will be based on the     presence/absence of a vomiting episode, use of rescue medication and subjective evaluation of     nausea. Patients will be monitored continuously in the PACU and on the hospital floor by the     caring team (nurse, resident, anesthesiologist, surgeon) for any emetic episode or use of     rescue therapy. An emetic episode is defined as an act of vomiting (oral expulsion of stomach     contents) or retching (non-productive vomiting). Nausea will be assessed at intervals of 0,     2, 6, 24 hours after surgery with T0 being time of extubation. Patients will rate nausea on a     11-point verbal rating scale, with 0 being not nausea to 10 being the worst nausea.     Rescue medication will be offered if the patient has more than one episode of vomiting or     retching, if the patient has nausea lasting longer than 15 minutes, or if the patient     requests it for established nausea or vomiting.   "
217419|NCT00699621|"     -  To prove whether use of antiplatelet agents results into a rapid enlargement of hematoma          after onset of acute intracerebral hemorrhage.        -  To prove the efficacy and safety of platelet transfusion for prevention of hematoma          growth in patients who were stricken by acute intracerebral hemorrhage while being on          antiplatelet medication.   "
217420|NCT00699634|"     The purpose of this proposed study is to conduct a randomized double-blind placebo controlled     trial assessing the benefit of nabilone in pain management and improvement of quality of life     in patients with phantom limb pain.      Our Hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the     phantom limb pain and improve quality of life, compared to the placebo controlled group. This     will be evident by finding significant differences in Visual Analogue Scale pain scores,     frequency of phantom pain episodes, the Depression, Anxiety and Stress Scale, and the     Groningen Sleep Quality Scale and daily prosthetic wearing time.   "
217421|NCT00699660|"     This project evaluated the impact of semi-structured, standardized interviews on the initial     PTSD C&P on the examination.   "
217422|NCT00699673|"     Objective: The purpose of the present study is to assess if perioperative variation of Brain     Natriuretic Peptide (BNP) levels is a predictor of mortality and morbidity after cardiac     surgery.Material and Methods: 500 consecutive patients will be enrolled prospectively in this     study before cardiac surgery under cardiopulmonary bypass. BNP levels will be measured prior     to surgery and at postoperative day 1. Variations of BNP levels will be analyzed to determine     if it is a predictor of mortality and morbidity after cardiac surgery. This dynamic     evaluation will be compared to other tools of risk stratification in cardiac surgery as the     EuroScore. All patients will be followed 3 years after the procedure.      Hypothesis: Perioperative BNP variations may be more sensitive than pre- or postoperative BNP     levels alone. Furthermore the perioperative homeostasis will be measured to assess its impact     on BNP secretion during the perioperative period.   "
217423|NCT00699686|"     Endothelial progenitor cell (EPC) level represents a surrogate marker of cardiovascular risk     and an indicator of the ongoing vascular damage. Moreover, EPCs are involved in the     pathogenesis of virtually all diabetic complications. Therefore, ways to modulate EPCs are     currently considered of utmost importance, especially in high-risk subjects. While many drugs     with pleiotropic vasculoprotective effects have shown ability to positively modulate EPCs,     there is no data on the effects of specific insulin formulations.      This is a human randomised cross-over comparison trial. The purpose is to compare the effects     of two basal insulin analogues (detemir and glargine) added to oral antidiabetic therapy in     poorly-controlled type 2 patients with cardiovascular disease on endothelial function and EPC     levels.      The aim is to test whether optimized glycemic control with add-on basal insulin analogues     improves endothelial damage and regeneration in type 2 diabetes with macroangiopathy and to     compare the effects of glargine vs detemir on markers of endothelial damage and regeneration.      EPC level is the most innovative outcome measure of this study and represents the primary     endpoint. Endothelial dysfunction/damage, evaluated using soluble markers, will be the     secondary outcome. Given the supposed inverse correlation between EPC and endothelial damage,     it is expected that EPC increase reflects amelioration in endothelial biology, a result that     may have significant clinical implications in this cohort of high-risk patients.   "
217424|NCT00699699|"     This observational non-interventional study is designed to demonstrate the improvement of     physical function in COPD patients on treatment with Spiriva Respimat and allows adverse     events to be recorded and evaluated.   "
217425|NCT00699712|"     To access the efficacy of intravenous (IV) administration of CD-NP on changes in cardiac     output and wedge pressure in patients with stabilized acute heart failure   "
217426|NCT00699725|"     Prospective multicentric study to evaluate the compliance of gastroprotective treatment in     NSAID patients at risk of GI complications. Secondary objectives: To identify the factors     associated to treatment compliance (both NSAID and PPI), to evaluate the relationship between     compliance and NSAID-associated GI events   "
217433|NCT00699816|"     To prove that the efficacy and safety of 'Green Cross CELL* Immuncell-LC group' is superior     to 'non-treatment group(Control group)' in patient undergone curative resection(PEIT, RFA or     operation) for hepatocellular carcinoma in Korea   "
217434|NCT00699829|"     Mohs' micrographic surgery (MMS) is a treatment of choice for high recurrence risk basal-cell     carcinomas (BCC). Realized under local anaesthesia, it induces very low recurrence rates and     spares unnecessary excision of intact surrounding tissues, thus decreasing the needs for     flaps, skin grafts, and allows immediate reconstruction…. Its disadvantages are mainly: need     for a significant training of the operator, the pathologist and the non-medical personnel;     longer duration of the procedure, with higher a priori costs, and constraints for the patient     related to the duration of the intervention. Traditional surgical excision with immediate or     differed reconstruction is the technique of reference. Provided that re-excisions are     performed as long as previous ones do not guarantee free margins, it gives good results. Its     real costs are poorly known and can be enhanced by several considerations: multiplicity of     the operational acts if the initial excision is insufficient, more complex reconstruction     procedures, duration of post-operative dressings, ….      The investigators' objective is to know the costs of the surgical treatment of the high risk     CBC, comparing the CMM with the surgical excision with immediate or differed reconstruction,     along with its effectiveness defined by the absence of recurrence. by its impact on the     quality of life of the patient. It is a prospective, multicentric, comparative, not     randomized, open, cohort study, of the type here and elsewhere. Patients with high-risk     CBC, as defined by the French ANAES Guidelines (2004), will be included:        -  clinically morpheaform aspect or ill-limited margins, aggressive histological forms;        -  already recurred BCC (except for superficial BCCs));        -  nodular BCC located in the high-risk zone (nose, peri-orificial areas of the head) and          with diameter larger than 1 cm.      The effectiveness will be measured by the rate of recurrence at 5 years (as measured by the     prolongation of the follow-up after the surgical procedure). The utility from the patient     point of view will be evaluated by a specific dermatologic quality of life questionnaire     (Skindex) and by a generic questionnaire (Euroqol 5D), supplemented by a questionnaire of     satisfaction of the care (Attkisson). The economic perspectives studied will be those of the     hospital, of the payer and of the society. Direct medical costs will be evaluated by     micro-costing. The main production factors implied in the realization of one CMM or one     traditional surgery in dermatology/surgery and anatomopathology wards will be identified,     counted, and developed. The measuring units will be the estimate of the time devoted to each     individual procedure, reported to the total activity of each ward and the wages of the     various categories of personnel implied, and the unit costs in consumable and redeemable     material, reported to their utilisation factor. The hospital indirect costs will be estimated     by the financial services of the hospitals. Accrual of 150 CMM and 300 traditional excisions     will be performed within a two year period of time.   "
217435|NCT00699842|"     Revlimid® (Lenalidomide) is indicated for a type of blood cancer, myelodysplastic syndrome     (MDS), at 10mg for a specific type of myelodysplastic syndrome with a genetic abnormality     called deletion 5q in Low and Intermediate-1 (INT-1) patients (staging system according to     International Prognostic Scoring System (IPSS)). The purpose of this Phase I/II study is to     determine the optimal dose of Revlimid® (Lenalidomide) in MDS Low and MDS INT-1 patients     without deletion 5q by slowly increasing the dose while monitoring blood counts for safety     evaluation as well as observe other adverse events. Efficacy will also be observed for the     phase II portion of the study.   "
217436|NCT00699855|"     Primary objective is to assess the relationship between changes from serum biomarkers     observed after 1 month of Saizen® therapy and change in height, weight after up to 5 years of     treatment with Growth Hormone in children with Growth Hormone Deficiency (GHD) and Turner     Syndrome (TS).   "
217440|NCT00699907|"     RATIONALE: Studying samples of blood and tissue in the laboratory from patients with a high     risk of developing ovarian cancer may help doctors identify and learn more about biomarkers     related to cancer. It may also help doctors learn more about the effects of flutamide on     biomarkers.      PURPOSE: This phase II trial is studying the effect of flutamide on biomarkers in blood and     tissue samples from patients at high risk of ovarian cancer.   "
217441|NCT00699920|"     Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction)     adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus     Coartem, based on the first malaria attack of each patient.      Secondary objectives:      For the first attack:      To compare the 2 groups of treatment in terms of:        -  Day 42 efficacy        -  Parasitological and fever clearance        -  Clinical and Biological tolerability        -  Evolution of gametocyte carriage      For attack 2nd and following:      To compare the 2 groups of treatment in terms of:        -  Day 28 and Day 42 clinical and parasitological effectiveness        -  Clinical and Biological tolerability        -  Proportion of patients without fever at Day 3        -  Proportion of patients without parasites at Day 3        -  Evolution of gametocyte carriage        -  Compliance      During the total follow up of the cohort:      To compare the 2 groups of treatment in terms of:        -  Treatment incidence density        -  Impact of repeated treatment on clinical and biological tolerability        -  Impact on anaemia        -  Impact on Hackett score.   "
217442|NCT00699933|"     The study aims to evaluate the course of patients with acute pancreatitis. Thereby we analyze     different diagnostics and compare ultrasound, MRI and CT-scan in detection of necrotic areas     and evaluate interventional therapy methods like percutaneous drainage techniques regarding     the outcome. Laboratory values were assessed as well.   "
217443|NCT00699946|"     In this study we wanted to determine if perioperative administration of olanzapine prior to     knee or hip replacement surgery in high risk patients would prevent the onset of     postoperative delirium.   "
217444|NCT00699959|"     The purpose of this observational study is to compare frequency of attainment control goals     through the more represented cardiovascular factor risk, dyslipidemia, among coronary     patients with or without heart failure in cardiology consulting.   "
217445|NCT00699972|"     The purpose of this study is to evaluate the safety, efficacy and tolerability of perampanel     when given as an adjunctive therapy in subjects with refractory partial seizures.   "
217446|NCT00699985|"     To find the overall psychological profile of patients with Behcet's Disease (BD) and compare     it with Non-BD patients.patients were checked for psychological symptoms by Symptom Check     List 90 Revised (SCL90-R)   "
217447|NCT00699998|"     This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a     medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute     coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary     revascularization).   "
217448|NCT00700011|"     The investigators hypothesize that, in addition to its apoptotic effect, clofarabine induces     DNA hypomethylation. If the investigators' hypothesis is correct, findings from the present     proposal will not only contribute to information relating to the mechanisms of action of     clofarabine but also provide the opportunity for combined epigenetic targeting of MDS using     clofarabine with either another hypomethylating agent or a histone deacetylase inhibitor.      Clofarabine has demonstrated anti-cancer activity through inhibition of DNA synthesis and     repair, induction of apoptosis, and possibly through other mechanisms. Numerous responses     have been observed after treatment with clofarabine in heavily pre-treated     relapsed/refractory patients with ALL, AML and high risk MDS.      In the present proposal, the investigators will study the clinical and laboratory effects of     2 different dosages of clofarabine in patients who have failed the hypomethylating agent,     5-azacytidine. This study will recruit patients who have received at least six cycles of     5-azacytidine without response or whose disease has progressed or relapsed while on     5-azacytidine. The first cohort of patients will receive clofarabine 10 mg/m2/day for five     days and the second cohort of patients 5 mg/m2/day for five days, both every four to six     weeks. The investigators will determine the frequency of response to the two dosages of     nucleoside analog in this group of patients. Measurement of responses will include     improvement in the peripheral blood count, reduction in the blood and platelet transfusion     need and eradication of cytogenetically abnormal clones. Successful completion of this study     will define the position of clofarabine in MDS in the era of epigenetic targeting.   "
217449|NCT00700024|"     The purpose of this study is to determine the effect of training and testim on Hypogonadism.   "
217450|NCT00700037|"     To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of     coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary     syndrome.   "
217496|NCT00700635|"     To explore the potential benefit of the administration of Menactra vaccine as a two-dose     regimen to children.      Primary Objective:      To assess, by age group, the immune response to Menactra vaccine after each vaccine     injection.   "
218521|NCT00713336|"     This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a     positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer   "
217451|NCT00700050|"     The general objective is to elucidate the mechanisms whereby sex hormones may modulate the     severity of respiratory disease. An important component of this proposal is a systematic and     intensive approach to characterize how the cellular and cytokine components of airway     inflammation respond to fluctuations in sex hormone levels.      The effects of menstrual fluctuations in levels of sex hormones on inflammation and bacterial     load in respiratory secretions of CF patients will also be determined.   "
217452|NCT00700063|"     This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and     0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the     face or scalp.   "
217453|NCT00700076|"     Org 25935 is a new putative antipsychotic agent developed by N.V. Organon.The primary     objective of this study is to investigate the effect of Org 25935 on ketamine-induced     impairments in immediate recall.   "
217502|NCT00700713|"     Study will evaluate the persistence of antibodies approximately three years after an initial     dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and     age-matched Menactra naive participants.      Objectives:        -  To assess the persistence of antibody responses three years after one or two doses of          Menactra® vaccine in subjects who participated in study MTA26.        -  To describe the antibody responses to a single dose of Menactra® vaccine in subjects who          had previously received one or two doses of Menactra® vaccine and in Menactra®          vaccine-naïve subjects.        -  To describe the safety profile of a single dose of Menactra® vaccine in subjects.   "
217454|NCT00700089|"     Background      Previous suicide attempts is a high-risk factor with a repetition rate between 12-30 percent.     Compliance with after treatment is often poor. A systematic review by Hawton, 1999 states a     lack of evidence on psychosocial interventions due to selections bias or statistical power.      Objective      The aim is to investigate if assertive outreach, incorporating hands-on guidance and     motivational support of compliance with follow-up treatment after suicide attempts is able to     reduce the frequency of non-fatal and fatal suicide acts in a one-year follow-up period.      Method and Design      A randomized, controlled intervention trial in a prospective design. The patients included     will be randomized to either standard treatment (n = 120) or intervention treatment (N =     120), representing 6 - 8 assertive outreach contacts with a research nurse after suicide     attempts or deliberate self-harm. The outreach contacts are thought of as supporting and     guiding home visits towards compliance with after care or follow-up treatment Inclusion     criteria Males and females, aged 12 years or older with a recent suicide attempt or act of     deliberate self-harm, living independently and not diagnosed with severe mental illness     (psychosis, severe dementia)      Outcome      The primary outcome measure is repeated fatal suicidal act (fatal or non fatal)assessed by     the Danish Cause of Death Register and the rate of repeated suicide attempts/deliberate     self-harm registered in the medical records by the collaborating wards and units in their     routine procedure of treating people applying for help in relation to suicidal behavior.   "
217455|NCT00700102|"     This study will evaluate the efficacy and safety of adding bevacizumab to crossover     fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have     experienced disease progression under first line treatment with standard chemotherapy plus     bevacizumab. Participants will receive chemotherapy alone, or in combination with     bevacizumab. The anticipated time on study treatment is until disease progression or     unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after     stopping chemotherapy.   "
217456|NCT00700115|"     This study will examine the effectiveness and safety of raltegravir (isentress) when used     together with lopinavir/ritonavir (kaletra) for the treatment of HIV-infection. Isentress is     a recently, Food and Drug Administration (FDA) approved, HIV medication that has strong     effects against the HIV virus. Isentress has been shown in other studies to be safe and well     tolerated by HIV patients. Combining this drug with kaletra might enable us to construct a     HIV regimen that does not include the more toxic drugs of the nucleoside reverse     transcriptase inhibitor class.      Eligible volunteers will undergo the following as part of the study procedure:        1. Sign the study consent form and the HIPAA Authorization Form.        2. Two-third of subjects, the intervention group (selected by random chance) will have          their HIV drug treatment changed to kaletra + isentress.        3. The other one-third will continue their usual HIV medications (this will be the control          group).        4. Make 9 study related visits to the Ponce clinic during the 48 weeks study period. During          these visits, medical information will be collected, and blood tests will be performed.        5. Perform Dexa-scan on two separate occasions at Emory University Hospital Radiology.      Information collected will be used to assess the effectiveness of this treatment in keeping     the HIV virus suppressed, how well these two drugs together is tolerated by HIV-infected     patients, and the blood levels of these two drugs when given together.   "
217457|NCT00700128|"     This study will examine the combined effects of a continuous oral contraceptive (OC) regimen     with supplemental frovatriptan therapy on headache severity and occurrence in subjects with     documented Menstrually Associated Migraines (MAM). The subjects enrolling in the study will     have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal     contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen     following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs,     the subject will institute a 4-day hormone-free interval (HFI). In an attempt to     prevent/lessen the severity of headache during the HFI, subjects will be randomized to     prophylactic administration of a triptan or placebo during this period. If no BTB/BTS occurs     after 80 days of continuous pills, the subject will institute a 4-day HFI during which they     will be randomized into triptan or placebo groups.      The purpose of this research study is to examine the effects of continuous oral contraceptive     pills and frovatriptan on headaches that occur around the time of your period. Many woman     take continuous oral contraceptive pills (OC) and when OCs are stopped they may get     headaches. This study will look if taking frovatriptan around the time of the period will     affect the headache, and how it will be affected. Frovatriptan is an FDA approved drug for     migraine headaches.      This study is a prospective pilot trial.The study will last approximately 35-39 weeks.   "
217458|NCT00700141|"     Considering the total number of thyroid procedures in Germany (100000 - 120000 cases per     year), TachoSil® is a valuable tool to support surgical haemostasis, avoiding lymph leaks and     support speech-nerve saving approaches. The aim of this study was to evaluate a patient and     procedure profile where TachoSil® is most beneficial.   "
217459|NCT00700154|"     Normoglycemia is important for the outcome of surgical and medical conditions. Insulin     infusions have been studied to achieve normoglycemia during these circumstances and have     proved to be useful. Insulin given by subcutaneous injections has longer duration compared to     intravenous given insulin which makes it more difficult to control. The hypothesis behind the     trial is the concept that insulin infusion is more effective in reaching normoglycemia in     diabetic subjects during treatment for ulcer infections and/or planned cardio-vascular     surgery.        -  The study evaluates a target controlled insulin infusion or conventional therapy as          antidiabetic treatment during ulcer infection and after cardio- vascular surgery.        -  Secondary efficacy parameter will be hospital stay, laboratories for inflammation and          oxidative stress.   "
217503|NCT00700726|"     The purpose of this study is to determine if a simple blood test can help in disease     management, particularly asthma. This will be researched by looking at certain features of     the blood and to compare asthmatics without allergies to those that have allergy-induced     asthma.   "
217504|NCT00700739|"     The purpose of the study is to evaluate the performance of the Discover cervical Artificial     disc in the treatment of degenerative disc disease in one level of the cervical spine.   "
217505|NCT00700752|"     This study seeks to evaluate the clinical and subjective performance of two established soft     contact lenses.   "
217460|NCT00700167|"     Cancer cells make proteins called antigens that act as markers for the tumor cells. These     antigens cannot cause the cancer itself. Special white blood cells, called T cells or T     lymphocytes, recognize and respond to antigens. In many diseases, these and other cells in     the immune system help your body get rid of the disease. However, T cells are normally     resting, and they need other proteins on the diseased cell surface to begin working.     Unfortunately, cancer cells do not usually make all the other proteins that T cells need to     work. Therefore, T cells do not normally work against the cancer cells. We think this is one     of the reasons that cancers grow and are not rejected by the body in the first place.      Another white blood cell, called a dendritic cell, does have most if not all of the special     proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not     normally have the cancer proteins on their surface. The challenge then is to combine the     cancer markers (antigens) with these dendritic cells to make a vaccine. We think that the     body's T cells might then react against the tumor and help destroy it. This study will see if     putting tumor antigens made in a lab onto dendritic cells will make T cells work against     tumor cells. We want to answer this question by injecting you with dendritic cells loaded     with the antigens. Then we will check for a response based on lab studies and your own     clinical course. We will compare your response against melanoma with your response against a     common antigen, to which almost everyone has already been exposed. Flu, for example, is a     common antigen to which most people have been exposed. We also need to test your response to     an antigen that your body has not likely seen before. For example, we plan to use KLH     (keyhole limpet hemocyanin), which is a pigment or color protein made from a sea creature     known as a keyhole limpet. Each of these, the flu and KLH antigens, which should be harmless     to you, will be used along with the dendritic cell-tumor vaccine. This will help us find out     if the vaccine is working, based on the lab studies we will check before and after the     vaccinations.   "
217461|NCT00700180|"     This study will explore the correlation of biomarkers with response rate, and the overall     efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in     patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be     randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week     cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive     treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles.     The anticipated time on study treatment is until disease progression, and the target sample     size is 100-500 individuals.   "
217462|NCT00700193|"     The purpose of this study is to determine the Safety, Tolerability & Immunogenicity of CSL     Limited's Influenza Virus Vaccine in a two dose primary vaccination series, with a 12-month     booster vaccination, in a paediatric population equal to or greater than 6 months to less     than 9 years old.   "
217463|NCT00700206|"     This is a randomized, open label, multicenter, Phase 2 study comparing two dose schedules of     Telintra in patients with Low or Intermediate-1 risk MDS. Patients at least 18 years of age     presenting with histologically confirmed Low to Intermediate-1 risk MDS with documented     significant cytopenia for at least two months by the IWG criteria are eligible.   "
217464|NCT00700219|"     The purpose of this study is to collect clinical specimens and corresponding clinical data to     develop a non-invasive test for detection of intra-amniotic infection and prediction of     preterm birth in women and intact amniotic membranes. The specimens collected will be used to     develop a specific biomarker panel and algorithm using immunoassays for optimal detection of     intra-amniotic infection in women with preterm labor and intact amniotic membranes.   "
217465|NCT00700232|"     Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a     subtype of progressive familial intrahepatic cholestasis, have been reported in women     suffering from intrahepatic cholestasis of pregnancy. The true incidence and the role of     these ABCB4 gene mutations in patients suffering from intrahepatic cholestasis of pregnancy     have not been clearly established.      The aim of the present study is to describe the nature and frequency of these mutations in a     series of patients with intrahepatic cholestasis of pregnancy and to compare with a control     group of pregnant women without intrahepatic cholestasis of pregnancy.   "
217466|NCT00700245|"     The human adipose and muscle -tissue produce and release a number of bioactive proteins which     contributes to the chronic low grade of inflammatory status which is associated with obesity     and plays an important role in the pathogenesis of type 2 diabetes and cardiovascular     diseases.      Study 1: Our aim is to investigate if exercise has independent and additive effects in     combination with diet-induced weight loss on circulating levels of inflammatory markers and     mRNA levels in subcutaneous adipose tissue (SAT) and skeletal muscle tissue (SM.      Study 2: Our aim is to investigate whether gender and weight status plays a role in the     metabolic response during two hours of acute exercise   "
217467|NCT00700258|"     The purpose of this registry is to obtain a general view as regards efficacy, tolerability     and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with     advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and     gastro-intestinal stroma tumors (GIST) under the conditions of routine use   "
217468|NCT00700271|"     This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label,     blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients     with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5     mg alone.   "
217469|NCT00700284|"     The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring     to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent     7-day exposure to a placebo ring containing no investigational agent. They then underwent     7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed     in terms of safety and tolerability as well as drug delivery.   "
217470|NCT00700297|"     Colchicine was first used in Behcet's Disease (BD), in 1977. There are controversial reports     of the efficacy of Colchicine in BD. For some experts the unresponsiveness of some patients     could be explained by genetic difference between the Silk Road BD and sporadic BD from other     parts of the world.      To test this hypothesis (the inefficacy of colchicine in the Silk Road BD), we designed a     randomized double-blind controlled crossover study in Iran, which is in the middle of the     Silk Road, and has the second highest prevalence of BD in the world.   "
217471|NCT00700310|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel     when given as an adjunctive therapy in subjects with refractory partial seizures.   "
217472|NCT00700323|"     To assess the effect of phosphatidylserine-omega-3 consumption on the immune system     parameters in children suffering from attention and concentration deficits.   "
217506|NCT00700765|"     This study is conducted in Asia. The aim of this observational study is to evaluate the     incidence of adverse events while using Levemir® under normal clinical practice conditions.   "
217602|NCT00702026|"     The purpose of this study is to determine whether a specifically designed multispecies     probiotic decreases visceral hypersensitivity in IBS-patient (defined by an increased pain     tolerance threshold). Moreover, the effect on general symptom scores and inflammatory and     microbiological parameters will be studied.   "
217473|NCT00700336|"     The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined     with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid     malignancy that is metastatic or unresectable and for which standard curative or palliative     measures do not exist or are no longer effective or would otherwise be eligible for cisplatin     and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined     based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet     combination will be assessed during the phase I part of the trial.      The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at     the MTD determined in the phase I part) in previously untreated, unresectable malignant     pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed,     cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be     stratified according to histology and performance status.   "
217474|NCT00700349|"     This study involves randomization of individuals who were initially rejected from a     micro-lending organization in South Africa. Subjects were placed into two arms: (1) not     receiving a loan; (2) being reconsidered for a second look. Of those in the second arm, 53%     were then selected by the organization's loan officers to receive a standard loan for     first-time borrowers. Mental health and financial data were collected at one timepoint:     approximately 6-12 months after the subjects first applied for the loan.   "
217475|NCT00700362|"     Normoglycemia is important for the outcome of surgical and medical conditions. Insulin     infusions have been studied to achieve normoglycemia during these circumstances and have     proved to be useful. Insulin given by subcutaneous injections has longer duration compared to     intravenous given insulin which makes it more difficult to control. The hypothesis behind the     trial is the concept that insulin infusion is more effective in reaching normoglycemia in     diabetic subjects during foot ulcer infection and surgical wound infection.        -  The study evaluates a target controlled insulin infusion or conventional therapy as          antidiabetic treatment during foot ulcer infection and surgical wound infection.        -  Secondary efficacy parameter will be hospital stay, laboratories for inflammation and          oxidative stress.   "
217476|NCT00700375|"     This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients     undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.   "
217477|NCT00700388|"     Mechanical devices to increase the individual's bronchial hygiene are commonly used in     patients with chronic retention of secretions and abnormal cough reflex. In this clinical     context a new technology (namely TPEP® - Temporary Positive Expiratory Pressure) has been     recently developed with the aim to improve the respiratory condition in patients suffering     from chronic respiratory diseases. This trial has the aim to assess the clinical efficacy of     TPEP in patients with chronic hypersecretion and airways obstruction, but with a normal     competence of the cough reflex   "
217478|NCT00700401|"     This single arm study will investigate the predictive value of a week 4 virological response     on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3,     treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180     micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4     will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up.     Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive     PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months,     and the target sample size is 100 individuals.   "
217479|NCT00700414|"     This study aims to collect demographic and medical information including detailed family     history of cancer of children and adolescents with adrenocortical tumors in order to learn     more about the clinical and epidemiological aspects, treatment modalities, and outcome of     patients with this rare disease, worldwide.      In addition, investigators at St. Jude Children's Research Hospital (SJCRH) plan to perform     molecular studies of tumor cells aimed to clarify the role of the TP53 gene and other genetic     pathways in these tumors. They aim to obtain relevant biological material from participants     with adrenocortical tumor (ACT), their biological parents, and relatives for determination of     the TP53 germline status, molecular studies of the TP53 gene, and other molecular pathways.   "
217480|NCT00700427|"     LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with     Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label     conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study.     Those patients that meet the response criteria will continue the blind phase of the study up     to a year. During that period, patients that respond to atomoxetine will be randomized to     continue the treatment with atomoxetine or with placebo (neither the patients nor     investigators know if patients receive atomoxetine or placebo).   "
217481|NCT00700440|"     This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT +     concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.   "
217482|NCT00700453|"     1. Young adults who are exposed to 7-10 days of play of violent video games will show          reduced activation in certain regions of the dorsolateral prefrontal cortex and anterior          cingulate cortex.        2. Young adults who are exposed to 7-10 days of violent video games will show increased          activation in regions of the amygdala.        3. Young adults who abstain from violent video games for a week, after 7-10 days of play of          violent video games, will show increased activation of regions in the dorsolateral          prefrontal cortex and anterior cingulate cortex and decreased activation of the          amygdala, on pre-post fMRI and compared to young adults who continue to play violent          video games.        4. Young adults who complete a computerized attention-training program after 7-10 days of          violent video games will show increased activation of regions in the dorsolateral          prefrontal cortex and anterior cingulate cortex and decreased activation of the          amygdala, on pre-post fMRI and compared to young adults who continue to play violent          video games.   "
217507|NCT00700778|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of recombinant human chorionic gonadotropin may prevent breast cancer in premenopausal women     with BRCA1 mutations.      PURPOSE: This clinical trial is studying recombinant human chorionic gonadotropin in     preventing breast cancer in premenopausal women with BRCA1 mutations.   "
219907|NCT00731614|"     The goal of this study is to test whether a combination of cognitive-behavior therapy and     mirror training reduces phantom limb pain for veterans with amputations.   "
217483|NCT00700466|"     Chronic beta-adrenoceptor blockade is known to improve outcome of high risk patients whereas     amelioration of autonomic activity was demonstrated to be a major cause of outcome     improvement. Therefore, perioperative beta-adrenoceptor blockade is recommended in patients     with Revised Cardiac Risk Index score of three or greater. The investigators hypothesise that     preoperative intravenous beta-adrenoceptor blockade for treatment of hypertension and/or     tachycardia improves autonomic activity reflected by increase of Total Power of Heart Rate     Variability.      Material and Methods: After IRB approval 20 patients scheduled for elective cardiac surgery     were included into the study. Routine medication was continued throughout the study as     recommended by the guidelines. HRV (TP and Low to High Frequency ratio (LF/HF) reflecting     sympathetic to parasympathetic balance) was analysed prior to induction of general anesthesia     and beta-adrenoceptor blockade in all patients (Baseline). Patients were assigned by their     baseline hemodynamics. Patients with hypertension (systolic blood pressure > 140mmHg or     diastolic blood pressure > 90mmHg) or tachycardia (heart rate > 80bpm) were assigned to group     BETA-BLOCK. In this group metoprolol-boli (2mg) were administered intravenously in stepwise     manner until hemodynamic values decreased to normal. Total dosage was recorded. After     normalisation of hemodynamics, second HRV analysis was performed (Intervention). Normotensive     and normocardic patients were assigned to group CONTROL. No intervention was performed.     Statistics: Mann Whitney U test for comparison between groups and between events Baseline and     Intervention within group BETA-BLOCK, p<0.05.   "
217484|NCT00700479|"     A randomized crossover trial to determine the effects of sodium loading and aldosterone     infusion on endothelial function in normal subjects.   "
217485|NCT00700492|"     A randomized study to investigate if hormonal luteal support after intra-uterine insemination     (IUI) in ovulation induction cycles with human menopausal gonadotropin increases the     pregnancy rate   "
217486|NCT00700505|"     To determine the safety and efficacy of the ThermaRx heating device for the application of     controlled low level heat to improve symptoms of LUT dysfunction (hesitancy, urgency).   "
217487|NCT00700518|"     The purpose of this study is to evaluate the blood flow response to topical Glyceryl     Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon.   "
217488|NCT00700531|"     Hypothesis: Free light chain removal haemodialysis will increase the rate of renal recovery     in patients with cast nephropathy, severe renal failure and de novo multiple myeloma.      This study will randomise patients with multiple myeloma and severe renal failure to     treatment to remove free light chains by haemodialysis or not.   "
217489|NCT00700544|"     A multicenter randomized trial evaluating the possible benefit of androgens during post     remission therapy in an attempt to improve the outcome of AML in older patients.All patients     received the ICL regimen as induction and were randomized to receive, after achieving CR or     PR, a maintenance therapy including or not androgens. Patients randomized with androgens     additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to     2 years   "
217490|NCT00700557|"     The purpose of this study is to know the efficacy of the treatment with probiotics,     Lactobacillus casei and Bifidobacterium breve, on clinical evidences and occurence of     relapses on antibiotic-associated diarrhea.   "
217491|NCT00700570|"     This single arm study will assess the resection rate of liver metastasis, time to disease     progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin     and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable     liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle,     oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5     and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and     the target sample size is <100 individuals.   "
217492|NCT00700583|"     The aim of the present study was to determine whether the combined administration of a     diuretic agent, hydrochlorothiazide, at night would improve the frequency of nocturia     unresponsive to alpha-blocker monotherapy in men with LUTS.   "
217493|NCT00700596|"     This study evaluates the effects of Salvinorin A (SA). SA is the active ingredient of the     plant Salvia divinorum that is known to have been used by Mexican Indians as part of     religious rituals. The purpose of this project is to understand what people experience when     they consume Salvinorin A.   "
217494|NCT00700609|"     The purpose of this project is to assess the effectiveness of a family-based therapy     (Attachment based family therapy-ABFT) for Norwegian adolescents (13-17 years) referred to     specialist mental heath clinics.   "
217495|NCT00700622|"     The objective of this study is to demonstrate that TI® Inhalation Powder combined with     Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.   "
218522|NCT00713349|"     The objective of the study is to compare the healing of wounds induced by cryo-injury when     treated with white petrolatum versus an ointment vehicle.   "
217497|NCT00700648|"     This study is conducted in Asia. The aim of this observational study is to evaluate the side     effects profile and benefits of using intravenous insulin aspart infusion in hospitalised     subjects under normal clinical practice conditions in India.   "
217498|NCT00700661|"     A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to     5 Years.   "
217499|NCT00700674|"     To determine if the usage of EEG Entropy helps to reduces the incidence of POCD in elderly     patients after general anesthesia.   "
217500|NCT00700687|"     We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different     treatments   "
217501|NCT00700700|"     A new therapy for patients with advanced heart failure (HF) involves the implantation of a     specialized pacemaker device (Cardiac Resynchronization Therapy, CRT) that attempts to     restore the synchronized contraction of the ventricular chambers of the heart. In some     people, CRT improves exertional breathlessness and allows them to exercise for longer     periods. However, to date, the mechanisms by which CRT improves symptoms and exercise     tolerance is unknown. This study will use in-depth cardiopulmonary exercise testing and     pulmonary function testing to explore these mechanisms in greater detail.   "
217508|NCT00700791|"     The overall goal of this study is to determine the efficacy of tocotrienol (TCT), a natural     form of vitamin E, in preventing or reducing scar formation in human skin wounds as well as     the basal levels of TCT in normal human skin and adipose tissue.   "
217510|NCT00700817|"     This trial is conducted in Europe and North America. The aim of this trial is to compare the     effect on blood sugar control of liraglutide or sitagliptin, both in combination with     metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.      The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:        1. Week 27-52 after randomisation           - All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and          dosing regimen.        2. Week 53-78 after randomisation             -  Subjects receiving sitagliptin at the end of week 52 after randomisation will               discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or               liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and               increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.             -  Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after               randomisation will continue the treatment at unchanged dose and dosing regimen.               Trial completion is planned for June 2010.   "
217511|NCT00700830|"     This study is conducted in Africa. The aim of this study is to assess the safety and efficacy     of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical     practice conditions in Algeria.   "
217512|NCT00700843|"     Obtain long-term follow-up results for bariatric patients who underwent medical management or     surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC).   "
217513|NCT00700856|"     Background: In patients with type 2 diabetes inadequately controlled with metformin, two main     therapeutic options are equally plausible: add-on a sulfonylurea (SU) or a thiazolidinedione     (TZD). Since the two classes of drugs clearly differ in terms of mechanisms of action, side     effects, economic costs and cardiovascular risk factors profile, a direct comparison of the     two therapeutic strategies would be most appropriate.      Aims: 1) To evaluate the effects of add-on pioglitazone as compared with add-on a SU on the     incidence of cardiovascular events in type 2 diabetic patients inadequately controlled with     metformin; 2) To compare the two treatments in terms of glycemic control, safety, and     economic costs.      Methods: multicentre, randomised, open label, parallel group trial of 48 months duration.     Eligible participants (type 2 diabetic males and females, aged 50-75 years, BMI 20-45 Kg/m2,     in treatment for the last two months with metformin 2 gr/die in monotherapy and with HbA1c >     =7.0% and <= 9.0%) will be randomized to add-on: a SU - glibenclamide (5-15 mg/die),     gliclazide (30-120 mg/die), glimepiride (2-6 mg/die), chosen according to local practice - or     pioglitazone (15-45 mg/die). A HbA1c value > 8.0 % on two consecutive occasions will lead to     addition of insulin to ongoing oral therapy.      Primary efficacy outcome: a composite endpoint of all-cause mortality, non fatal MI     (including silent MI), non fatal stroke, and unplanned coronary revascularization.      Secondary outcomes. Principal secondary outcome: a composite ischemic endpoint of sudden     death, fatal and non fatal acute MI (including silent MI), fatal and non fatal stroke, major     amputations (above ankle), endovascular or surgical intervention on the coronary, leg or     carotid arteries.      Other secondary outcomes      - a composite cardiovascular end point including the primary end point plus hospitalization     for heart failure, endovascular or surgical intervention on the coronary, leg or carotid     arteries, silent MI, angina - by WHO criteria and confirmed by a new electrocardiogram     abnormality - intermittent claudication with an ankle/brachial index lower than 090; events     of heart failure; a microvascular endpoint including: plasma creatinine increase of 2 times     above the baseline value or creatinine clearance reduction of 20ml/min/1. 73m2 or development     of overt nephropathy (dialysis or plasma creatinine >3,3 mg/dl) or macroalbuminuria; glycemic     control (changes from baseline in HBA1c, time to failure of glycemic control, i.e., HBA1c     >8.0% on two consecutive occasions three months apart); major CV risk factors (lipids, blood     pressure, microalbuminuria, inflammation markers, waist circumference); safety and side     effects; direct and indirect costs.      Data regarding CV endpoints, safety, tolerability, and study conduct will be monitored and     analyzed by an independent committee, and will be not available to the study investigators     until the closing of data collection. Efficacy end points will be analyzed on an     intention-to-treat basis.   "
217514|NCT00700869|"     The purpose of this study is to determine if a weaning strategy from artificial ventilation     governs by respiratory behaviour status assessed by our method is safe enough.   "
217515|NCT00700882|"     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with     locally advanced or metastatic mucosal melanoma or acral melanoma.   "
217516|NCT00700895|"     Interethnic differences in warfarin dose requirements in the Asian population have been well     described. Our previous studies showed that warfarin maintenance doses in our multi-ethnic     population were closely related to patient demographics and genetic polymorphisms in     cytochrome(CYP)P4502C9 and vitamin K epoxide reductase complex subunit 1(VKORC1). A     retrospective regression model combining these predictors accounts for 57.8% of the     variability in warfarin dose.   "
217517|NCT00700908|"     Aim 1. Determine the impact of a daily, automated telephone intervention on HbA1c levels     compared to standard care in older patients with type 2 diabetes.      Aim 2. Determine the impact of the automated telephone intervention compared to standard care     on adherence to prescribed SMBG frequency in older patients with type 2 diabetes.      Aim 3. Determine the impact of the automated telephone intervention compared to standard care     on self-reported diabetic control problems in older patients with type 2 diabetes.      Aim 4. Determine the impact of the automated telephone intervention compared to standard care     on self-reported attitudes and health beliefs concerning diabetes in older patients with type     2 diabetes   "
217518|NCT00700921|"     This study will test whether lovastatin helps to modify lung inflammation in patients with     COPD (Chronic Obstructive Pulmonary Disease).   "
217519|NCT00700934|"     The aim of this study is to describe the natural history of patients with alpha-1 antitrypsin     associated emphysema and to figure out associated prognostic factors.   "
217520|NCT00700947|"     The purpose of this study tests whether a beta-blocker drug will benefit patients with     chronic mitral regurgitation.   "
217521|NCT00700960|"     This study is conducted in Europe. The aim of this observational study is to describe the     conditions for the concomitant administration of a slow-acting insulin analogue with oral     antidiabetics (OADs) in order to improve blood glucose control in type 2 diabetes.   "
217522|NCT00700973|"     This project is intended to help substance use disorder patients who perpetrate interpersonal     violence against other adults.   "
217523|NCT00700986|"     The purpose of the study is to determine whether treatment with a single 800mg dose of     AZD9056, a medication which has been developed as a possible treatment for Rheumatoid     Arthritis, has an effect on the function of the retina   "
217524|NCT00700999|"     The purpose of this study is to examine if treatment of post-traumatic stress disorder in     combat veterans with paroxetine changes brain responses as measured by functional magnetic     resonance imaging and if brain responses can predict who will get better with treatment.   "
217525|NCT00701012|"     The purpose of this study is to evaluate the defecatory function when nerve fibers around the     inferior mesenteric artery(IMA) and left colic artery(LCA) are preserved(so called low     ligation ) or not(high ligation) in the rectosigmoid and rectal cancer surgery.   "
217535|NCT00701155|"     This study is conducted in Africa. The aim of this observational study is to evaluate the     incidence of serious adverse drug reactions while using insulin Levemir® under normal     clinical practice conditions in Egypt.   "
217526|NCT00701025|"     The term exercise-induced bronchospasm (EIB) describes acute, transient airway narrowing that     occurs during, and most often after, exercise. Manifestations of EIB can range from mild     impairment of performance to severe bronchospasm and respiratory failure.      The pathogenesis of EIB remains controversial and the role of airway inflammation has not yet     been definitively characterized. We plan on comparing markers of inflammation in asthmatic     participants with and without EIB at baseline and after bronchoprovocation with eucapnic     voluntary hyperventilation testing (EVH). We also will collect demographic information as     well as information about asthma control and exercise habits.   "
217540|NCT00701220|"     The purpose of this study is to see if taking a cholesterol lowering drug (LIPITOR®) will     increase the number of endothelial progenitor cells (EPC's) circulating in the blood of heart     failure patients taking this cholesterol-lowering drug, and if this will also show an     improvement in the damaged areas of the patient's hearts as documented by MRI scans.   "
217541|NCT00701233|"     To compare local steroid injections to local Botulinum toxin A injection in a double-blinded     study.   "
217601|NCT00702013|"     The P-glycoprotein (P-gp) is a membranous transporter that modulates the intracellular     concentrations of many drugs and plays thus a major role in the efficacy of the therapeutics     that act within the lymphocytes, such as antiretroviral drugs. We aim at studying the     evolution of this transporter's expression and activity on lymphocytes in relation with the     human development from newborns to adults. We also aim at studying the influence of HIV and     antiretroviral treatments on this transporter, especially anti-protease drugs, within the     children population.   "
217527|NCT00701038|"     Congestive heart failure affects 2.3 percent of the population (approximately 4,900,000) with     an incidence of 10 per 1,000 of the population after the age of 65 (1). The admission rate     for patients with heart failure is on the rise, so is the mortality associated with it and     its national annual bill, now exceeding $21 billion (1). Obstructive Sleep Apnea (OSA) is     present in 11-37 percent of patients with heart failure (2,3), and tends to increase in     severity when the heart failure is less controlled (4, 5). Therefore, the actual prevalence     of OSA in patients hospitalized with acute heart failure is likely higher. There is now     evidence that treatment of OSA with nasal Continuous Positive Pressure (nCPAP) in outpatients     with stable heart failure improves left ventricular ejection fraction, and quality of life     (6), and confers a reduction in fatal and non-fatal cardiovascular events (7). However, there     has not been any evaluation of the role of diagnosis and treatment of OSA in patients     hospitalized with acute heart failure. This uncertainty about the true prevalence and role of     OSA in exacerbations of heart failure, and the role of its treatment in the acute setting may     explain why aggressive diagnostic and therapeutic strategy for OSA in patients admitted to     the hospital with acute heart failure is not part of the standard clinical practice in acute     care centers. Given the rising admission rate, and mortality associated with heart failure,     an evaluation of the role of OSA and its treatment in this patient population is highly     significant.   "
217528|NCT00701051|"     Diabetes and its associated complications affect more than 20 million Americans, and the     prevalence of type 2 diabetes and impaired glucose tolerance rises dramatically with age such     that 40% of Americans over age 60 are affected. In older adults, glucose metabolism may be     affected by reduced skeletal muscle capillary supply, which limits insulin, glucose, and     oxygen delivery to skeletal muscle. Reduced capillary supply to skeletal muscle is found in     older individuals with impaired glucose tolerance and we hypothesize that this is due to     reduced vascular growth factor expression, and chronic inflammation. Further, we hypothesize     that reversal of a sedentary lifestyle through aerobic exercise training will increase     insulin signaling and vascular growth factor expression, as well as decrease inflammation, to     increase capillary supply to skeletal muscle, which contributes to improved glucose     metabolism in older adults. This study will: 1) Determine the mechanisms underlying reduced     skeletal muscle capillarization in older adults with impaired glucose tolerance; and 2)     Determine the effect of aerobic exercise training-induced increases in skeletal muscle     capillarization on glucose metabolism in older adults.   "
217529|NCT00701064|"     The investigators are testing novel treatments for combat PTSD: bright light exposure and     negation ion exposure.   "
217530|NCT00701077|"     The Brugada syndrome is a rare disease potentially leading to severe arrhythmic events in     otherwise healthy subjects.In many patients an Implantable cardiovertor defibrillator (ICD)     is implanted to prevent sudden cardiac death. ICD are however associated with potential     complications and are not available in all countries.Pharmacological blockade of specific ion     channels (Ito) represents a promising therapeutic approach in this syndrome.The     3,4-diaminopyridine (3,4-DAP) is a pharmacological Ito blocker that can be used in humans.The     aim of the study is to evaluate the effect of 3,4-DAP on ventricular arrhythmia inducibility     in Brugada patients requiring an electrophysiological study for arrhythmic risk     stratification.   "
217531|NCT00701090|"     A study to see if better control of type 2 diabetes can occur in patients taking a stable     dose of metformin when they are also provided either sitagliptin or glimepiride. This study     will also see if this treatment is safe and tolerable.   "
217532|NCT00701103|"     This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly,     every other week. or a every three week infusion.      The hypothesis of this study is that administration of dalotuzumab as a one- to two-hour     weekly, every other week, or every three week infusion in participants with advanced cancer     will be generally safe and tolerated at a dose which achieves a trough concentration ≥3     μg/mL.   "
217533|NCT00701129|"     The purpose of this study was to evaluate the efficacy, clinical benefits and safety of a     prophylactic immunomodulatory regimen given prior to first treatment with alglucosidase alfa     (Myozyme®) in patients with infantile-onset Pompe disease.      The objectives were to assess the efficacy of a prophylactic immunomodulatory regimen given     prior to first treatment with alglucosidase alfa, as assessed by anti-recombinant human acid     alpha-glucosidase (anti-rhGAA) antibody titers, and antibodies that inhibit the activity     and/or uptake of alglucosidase alfa; to evaluate the clinical benefit as measured by overall     survival, ventilator-free survival, left ventricular mass index (LVMI), gross motor function     and development, disability index and the incidence of adverse events (AEs), serious adverse     events (SAEs), and clinical laboratory abnormalities.   "
217534|NCT00701142|"     The primary purpose is to show that administration of Haemocomplettan® P significantly     reduces the amount of blood products needed during aortic surgery.   "
217536|NCT00701168|"     The purpose of this protocol is to provide supervised and limited access to Therasphere®     treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis     who cannot be treated by surgical removal of the affected part of the liver. Patient response     to treatment and any side effects of Therasphere® treatment will be examined.   "
217537|NCT00701181|"     To evaluate the effectiveness of study drug in improving visual acuity compared to laser     treatment in the patients with diabetic macular edema   "
217538|NCT00701194|"     The Early Intervention Foster Care [EIFC] project is an efficacy trial of the Oregon Social     Learning Center Multidimensional Treatment Foster Care Program, a preventive intervention     that targets 3 commonly co-occurring variables among young foster children: (1) behavioral     problems, (2) physiological dysregulation within the neuroendocrine system (i.e., HPA axis     activity), and (3) developmental delays.   "
217539|NCT00701207|"     The purpose of this study is to compare peoples with disease (sarcoidosis) to those without     disease. We want to see if people with sarcoidosis have a different immune response to those     people without disease.      The goal of this study is to see if the nicotine patch is an anti-inflammatory treatment for     sarcoidosis.   "
217542|NCT00701246|"     Iron deficiency anemia is the most common nutritional problem in the world.      The objectives of this study are:        -  to evaluate the prevalence of anemia in children from 6 to 24 months of age and the          therapeutic and prophylactic response to ferrous sulfate plus folic acid on hemoglobin          levels.        -  to compare the effect of folic acid supplementation with ferrous sulfate on the linear          and weight growth of anemic and non-anemic      Study hypothesis:        -  The ferrous sulfate plus folic acid can improve the response on hemoglobin levels.        -  The folic acid supplementation with ferrous sulfate have effect on the linear and weight          growth of anemic and non-anemic.   "
217543|NCT00701259|"     Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic     stomach contents move upward into the esophagus from the stomach. This study will investigate     the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing     frequent nighttime heartburn.   "
217544|NCT00701272|"     The main objective of this study is to assess whether a recently-developed bioassay for the     molecule secreted fibrinogen-like protein 2 (sFGL2) can be used to predict the recurrence     and/or progression of Hepatitis C Virus disease in post liver transplant patients. The     hypothesis is that patients with chronic HCV have higher than normal levels of sFGL2 in their     blood both pre- and post-transplantation and that this will inhibit their ability to clear     HCV, and influence the progression of HCV disease when it recurs.   "
217545|NCT00701285|"     We want to evaluate the utility of statins on heart function according to potency. Patients     with chronic ischemic heart failure are administered pitavastatin 4mg or pravastatin 10mg for     52 weeks. Then we evaluate the effect of pitavastatin and pravastatin primarily on rate of     hospitalization for cardiovascular cause and lipid profile secondarily biomarker,     echocardiography parameter, 6-minute walk, change of NYHA class distribution, cardiovascular     mortality.   "
217546|NCT00701298|"     This phase I trial is studying the side effects of decitabine when given together with or     without interferon alfa-2b, and the best dose of interferon alfa-2b, in treating patients     with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as decitabine,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Biological therapies, such as interferon alfa-2b, may stimulate     the immune system in different ways and stop tumor cells from growing. It is not yet known     whether decitabine is more effective when given with or without interferon alfa-2b in     treating solid tumors.   "
217547|NCT00701311|"     Prostatitis is the most common urologic diagnosis in men under the age of 50 and the third     most common diagnosis in older men. In Chronic Prostatitis (CP) or Chronic Pelvic Pain     Syndrome (CPPS), men have lower urinary tract symptoms, pelvic pain, sexual dysfunction and     decreased quality of life. Little is known about the cause of CP/CPPS. Likewise, no     definitive therapy exists for CP/CPPS. We plan to study the use of CC-10004 in men with     CP/CPPS.   "
217548|NCT00701324|"     The main objective of this trial is to provide safety data in terms of drug-related adverse     events (AE) for the recommendation of the dose for further trials in the development of BI     811283.      Secondary objectives are the collection of antitumour efficacy data and the determination of     the pharmacokinetic profile of BI 811283.   "
217549|NCT00701337|"     The aim of this pilot study conducted in post-menopausal women is to evaluate the effect of     17ß-estradiol administration on inflammatory-immune cells, namely antigen-presenting cells     (monocytes/dendritic cells), and more precisely on their activation by inflammatory stimuli.     This study will allow us to determine our ability to recruit menopausal women and to     characterize the optimal primary end-point among the numerous criteria tested   "
217550|NCT00701350|"     The purpose of this study is to investigate the expression of protein biomarkers in cervical     vaginal fluid in women with preterm premature rupture of membranes (PPROM)   "
217551|NCT00701363|"     The purpose of the study is to assess the efficacy of an extended injection interval schedule     of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long     term treatment with octreotide LAR 10 or 20 mg   "
217552|NCT00701376|"     Liver disease in the morbidly obese is thought to occur due to the long-term presence of fat     deposits in the liver, resulting in inflammation and scarring of the liver over time, which     reduces liver function. However, many of these patients are unaware that their liver is     damaged. There is currently no consensus regarding what the long-term effects of gastric     bypass surgery are on pre-existing liver disease in morbidly obese patients. This study will     determine the long-term effects on the liver after this type of surgical procedure.   "
217553|NCT00701389|"     Study to understand the effects of migraine treatments on blood pressure in participants with     migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure     following the coadministration of telcagepant and sumatriptan is similar to that following     administration of sumatriptan alone. That is, the true mean treatment difference (sumatriptan     with telcagepant sumatriptan alone) in time-weighted mean arterial pressure for 2.5 hours     following dosing is less than 5 mmHg.   "
223873|NCT00782665|"     This study is designed to demonstrate that women in labor become infected without exhibiting     any clinical signs or symptoms of infection.   "
217554|NCT00701402|"     The purpose of this observational study is to describe the time to lipid-lowering drug     implementation in the management of dyslipidemic patients, according to the cardiovascular     risk level.   "
217555|NCT00701415|"     The purpose of this study was to determine whether 2 alternative dosing regimens of Fabrazyme     (Agalsidase beta) (1.0 mg/kg every 4 weeks or 0.5 mg/kg every 2 weeks) were effective in     treatment-naïve pediatric participants without severe symptoms. Participants were to be     treated for 5 years.   "
217556|NCT00701428|"     Obstructive sleep apnea (OSA) is a highly prevalent condition in hypertensive patients. The     renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An     angiotensin-II-antagonist, Losartan, is an effective antihypertensive drug. However, some     patients respond to this drug worse than the others, and it is a clinical praxis to either     increase the dosage and/or add another drug. There is limited data regarding the impact of     antihypertensive drugs in OSA patients, i.e., whether or not OSA may constitute the subgroup     of therapy-resistent hypertensive patients. In the literature, there is no data, either,     whether or not CPAP treatment may have an additive blood pressure lowering impact in this     certain subgroup.   "
217721|NCT00695487|"     The investigators evaluate if intravenously applied THC (Cannabis) reduces postoperative     Nausea and vomiting. THC will be given during anesthesia before emergence. We measure how     long and how effective it reduces PONV   "
217557|NCT00701441|"     Obstructive Sleep Apnea (OSA) is the most common sleep disorder affecting up to 9-24 percent     of middle aged adults, and is becoming increasingly implicated in the pathogenesis of     hypertension, and other cardiovascular disorders. Up to half of patients with OSA have     hypertension, and their risk of developing hypertension increases with the increasing     severity of Sleep Apnea. Patients with OSA and no hypertension have endothelial dysfunction,     which is believed to be the precursor for most cardiovascular disorders.      The upper airway collapse and obstruction that occur in OSA result in a pattern of     intermittent hypoxia, that has been shown to be the cause of the hypertension, and     endothelial dysfunction found in patients with OSA. Intermittent hypoxia results in oxidative     stress, which in turn is linked to the pathogenesis of hypertension and endothelial     dysfunction.      This protocol evaluates the role of the oxidative stress in endothelial function and blood     pressure in patients with OSA. This is a pilot clinical study that will compare oxidative     stress parameters, and endothelial function in patients with OSA before starting treatment     with continuous positive airway pressure (CPAP) and 12 weeks post being on CPAP. These     patients will be compared to control patients with no history of OSA. the study does not     involve assignement to different treatments. All patients will receive the indicated     treatment for OSA and measurements will be collected before and 12 weeks after adequate     treatment.   "
217558|NCT00701454|"     The purpose of this study was to determine the prevalence and risk factors of diabetes,     hypertension, hyperlipidemia among Thai muslim population aged 35-75 years.   "
217559|NCT00701467|"     To investigate changes in HRV during the time before a spontaneous episode of ventricular     tachyarrhythmia.   "
217560|NCT00701480|"     Skin cleanser for daily used is essential and one of the most common questions asked by acne     patients. There are studies reported beneficial effects of cleansers in acne treatment.     Extracts of plants as active ingredients in skin cleansers are increasingly popular     worldwide. Roselle is a common tropical shrub. Usually, the calyces of the plant have been     used to make beverages but it also used in Thai traditional medicine for several purposes     including as antiseptic and astringent. The extract of roselle showed antioxidant and     keratolytic effects from previous studies which fit to the pathogenesis of acne. The aims of     the study is to determine the safety and efficacy of skin cleanser contained roselle extract     in acne.   "
217561|NCT00701493|"     The primary purpose of this study is to estimate the bioavailability of the oral liquid     formulation of topiramate relative to the commercially available oral sprinkle capsule     formulation in healthy patients. If appropriate, bioequivalence between the oral liquid     formulation and the sprinkle capsule formulation will be assessed.   "
217562|NCT00701506|"     The purpose of the study is to investigate the benefits of the Patterned Neuromuscular     Electrical Stimulation (PENS) for the treatment of osteoarthritis. The rationale for this     investigation is to assess the benefit of PENS in the alleviation of symptoms of     osteoarthritis and elucidating the mechanism of action of PENS.   "
217563|NCT00701519|"     OSA is associated with large negative swings in the intrathoracic pressure, significant     increase in the sympathetic nerve activity and repetitive surges in blood pressure, along     with episodic hypoxia and hypercapnea (8,9). These autonomic and respiratory changes may     increase the cardiac muscle workload, cardiac dysrrhythmia, and exacerbate ischemia     (10,11,12). Treatment with CPAP is the most successful therapeutic modality available for     OSA. It is still not clear whether establishing the diagnosis of OSA and initiating treatment     with CPAP while still in the hospital carries any benefit in the management of patients with     acute heart failure. This study will evaluate the effect of work up and treatment of OSA on     the outcome of patients hospitalized with acute CHF.   "
217564|NCT00701532|"     -Context: Study objectives Primary: impact of modafinil versus placebo on DAT density     modifications in the striatal and extra-striatal regions in cocaine dependent subjects     hospitalised from D3 to D21.      Primary Hypothesis:      More rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo     from D3 to D21 during cocaine detoxification.   "
217565|NCT00701545|"     As part of CSL Behring Canada's continued commitment to ensuring the safety of the new low     volume preparation of Humate-P®, CSL Behring Canada proposes to conduct a prospective,     multi-center structured data collection of routine management of patients with von Willebrand     disease treated with Humate P® ivr in Canada. The surveillance will be non-interventional and     non-experimental. During the observation period, the routine medical care of the patient will     be documented.      It is expected that there will be no difference in the safety and tolerability of Humate-P®     ivr compared to Humate-P®   "
217566|NCT00701558|"     This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in     chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell     lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination     with gemcitabine 1000 mg/m^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The     anticipated time on study treatment is until disease progression, and the target sample size     is <100 individuals.   "
217567|NCT00701571|"     The purpose of this study is to compare the analgesic efficacy of three different types of     video/audio distraction in normal volunteers subjected to carefully controlled and     non-injurious thermal pain delivered to the skin of the lower back, simulating discomfort of     a lumbar puncture. Two of the distraction techniques include immersive virtual reality (VR).     The most efficacious distraction technique will be used in a subsequent clinical study in     cancer patients.   "
217568|NCT00701584|"     Diet has been found to influence hormone production and metabolism which in turn could affect     the incidence of hormone related cancers. Consumption of soy-containing foods, known to be     rich in phytoestrogens, is thought to be one of the chemoprotective factors against breast     cancer in Asian populations. Phytoestrogens have a wide range of metabolic effects and may     have a role in effecting breast cancer risk. Although there is mounting evidence of the     positive influence of phytoestrogens on breast cancer risk, very little research has been     carried out in humans as to the effects of phytoestrogens on breast cancer recurrence and     survival. The DietCompLyf study aims to explore this effect by carrying out an observational     study in 3,000 breast cancer women in the UK. The effects of diet, lifestyle practices and     use of complementary treatments will also be investigated. Participants are recruited 9-15     months post-diagnosis and followed up for 5 years. Questionnaires as well as blood and urine     samples are collected annually.   "
217569|NCT00701597|"     Several lines of evidence suggest now that ocular perfusion abnormalities may contribute to     the progression of glaucoma. It has been hypothesised that increased endothelin-1 plasma     levels, as seen in patients with glaucoma, may be related to these alterations in ocular     blood flow. We could show in recent experiments that administration of ET-1 decreases ocular     blood flow, whereas blocking of the ET-A receptors do not affect basal vascular tone in     healthy subjects. In the current study we set out to evaluate the effect Bosentan, a     non-selective ETA-receptor antagonist in patients with open-angle glaucoma. This should allow     us to test the hypothesis that administration of an ET-1 receptor antagonist increases ocular     blood flow in patients with glaucoma.      Investigations will be done with a retinal vessel analyzer to determine retinal vessel     cross-sectional diameters, with laser Doppler flowmetry and laser Doppler velocimetry to     determine subfoveal macular blood flow and optic nerve head blood flow and with laser     interferometric measurements to determine fundus pulsation amplitude in the macula. The     intraocular pressure will be measured with applanation tonometry. This will be assessed at     baseline and in response to peroral application of Bosentan or placebo.      The study objective is therefor, to evaluate the contribution of ET-1 to ocular blood flow     dysregulation in patients with open-angle glaucoma.   "
217570|NCT00701610|"     Von Willebramd Factor (VWF) is an adhesive glycoprotein synthesized by megakaryocytes and     endothelial cells.VWF has a central role in primary hemostasis and is a critical ligand for     platelets adhesion and aggregation (1, 2).VWF is the carrier of circulating factor 8 as well.     VWF is stored in Wiebel-Palade bodies in endothelial cells and in platelets alfa granules in     a form of Ultra-large (UL) multimers.      The VWF multimers are composed from subunits which are linked by disulfide bonds that     alternate between 2 C- terminal ends and 2 N- terminal ends in a head-to-head and     tail-to-tail fashion (3, 4). The biological activity of VWF has been shown to be related to     the size of the multimers.      VWF is released from endothelial cells toward the plasma as a multimers ranging from     500-20,000 kD. The UL multimers are hemostaticallly more effective than the smaller forms.     They spontaneously bind to platelets which lead to the formation of microthrombi in the     circulation. This mechanism is downregulated by the plasma protease ADAMTS-13(A Disintegrin     And Metalloprotease with ThromboSpondin motif).If the proteolysis become defective the ULVWF     will bind to platlets resulting in systemic thrombotic microangiophaties (TMA) such as     thrombotic thrombocytopenic purpura(TTP)(5,6).      ADAMTS-13 belongs to the ADAMTS family of metalloproteases.The structure of ADAMTS-13 is     conserved throughout vertebrates, indicating its important function (7).The metalloprotease     function was first describe 11 years ago and has been cloned and characterized (8-13).The     ADAMTS family of metaloploproteases is required in other systems such as genitourinary system     (ADAMTS1), collagen system (ADAMTS2) and as a cleaving protease of VWF (VWFCP) - ADAMTS13.     When VWF multimer is subjected to sufficient fluid shear stress ADAMTS-13 cleaves VWF at a     unique 842Tyr- 843Met bond in domain A2 (14,15).This cleavage produce VWF subunit fragments     of 176 kDa and 140 kDa.      The activity of ADAMTS-13 depends on both Zn+2 and Ca+2 ions (16). Low levels or deficiency     of ADAMTS-13 is seen in patient with TTP(17,18). Mannuccio et al (19) showed that low levels     of ADAMTS-13 are seen in other conditions such as healthy adults older than 65 years,     patients with cirrhosis, uremia, acute inflammation, postoperative period. In neonate and     preterm infants the data is limited. Few studies have shown that levels of ADAMTS-13 are low     in neonate (19-21).Tsai et al (22) observed that ADAMTS-13 activity is normal in cord blood     compared to adults. In preterm infants a pilot study showed that preterm have low levels of     ADAMTS-13(23).      The aim of our study is to check ADAMTS-13, VWF multimers, VWF antigen and VWF collagen     binding activity in healthy and sick neonate and in preterm infants.   "
217571|NCT00701623|"     Burns are injuries caused by agents thermal, chemical, electrical or radioactive who act in     the tissue lining of the human body and may partially or totally destroy the skin and its     annexes, to the deeper layers, as subcutaneous tissue, muscles, tendons and bones .      Studies show that topical heparin has, in addition to the already known anticoagulant     activity, anti-inflammatory properties, analgesic, and neoangiogenic, stimulating blood flow     and increasing the repair of the fabric as well as the restoration of collagen and     reepiteliztion. Moreover, the use of heparin reduces the need for painful medical procedures,     as debridations, surgeries and transplants The intention of this work is to verify the     effectiveness and safety of sodium heparin in the treatment of burns of the skin.   "
217572|NCT00701636|"     This investigation is a prospective, open-label pharmacokinetic study of daptomycin     prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular     replacement.   "
217573|NCT00701649|"     CYT006-AngQb is a vaccine that induces a B-cell mediated immune response characterized by the     generation of specific antibodies (IgG and IgM) against Angiotensin II. The vaccine is     administered by subcutaneous injection.      The objectives of the study are:        -  To evaluate safety and tolerability of 5 s.c. injections of 300µg CYT006-AngQb with          Alhydrogel™ in patients with mild to moderate essential hypertension (hypertension Grade          I and II).        -  To assess pharmacodynamic effects, i.e. anti-Ang II immune response and renin-          angiotensin system (RAS) biomarkers.        -  To explore the effect on blood pressure using ABPM.   "
217574|NCT00701662|"     The objective of this study is to assess efficacy, safety, and convenience of purified human     antibodies administered under the skin in the treatment of MMN patients.   "
217582|NCT00701766|"     The present trial will be performed to determine the MTD and to evaluate the efficacy of BI     2536 in the treatment of elderly patients with relapsed or refractory AML. Different     schedules will be compared to identify the better dosing schedule for the further development     programme of BI 2536. Dose escalation starting with the maximum tolerated dose previously     determined in patients with advanced solid cancers will be performed to determine the maximum     tolerated dose for AML patients.   "
217575|NCT00701675|"     Generalized anxiety disorder (GAD) is a very common disorder in the geriatric population with     prevalence rates reaching 7% and even higher rates of 8% among elderly veterans. However,     despite such high prevalence treating clinicians are presently forced to address treatment     issues in this population without the guidance of scientific data. This proposal aims to     begin to address this void.      In light of emerging information regarding efficacy of the newer anti anxiety agents,     specifically the selective serotonin reuptake inhibitors (SSRIs), in the treatment of young     adult GAD patients it is time to prospectively evaluate the safety and efficacy of these     medications in the treatment of elderly GAD patients. Therefore, this study will examine the     effects and safety of the SSRI sertraline at different doses (50mg and 100mg per day) for     older patients with GAD.   "
217586|NCT00701818|"     The specific objectives of this thesis are in a cohort of patients with an acute ischemic     stroke,        1. To establish the degree of coronary arteriosclerosis.        2. To describe left ventricular systolic and diastolic function in relation to changes of          NT-proBNP.   "
217587|NCT00701831|"     Primary objective:        -  To observe the efficacy of the forced titration to reach good glycemic control in Lantus          treated patients      Secondary objectives:        -  To assess the forced titration on physician and patient satisfaction        -  To evaluate the impact of training tools by means of patient profile   "
217588|NCT00701844|"     The Sharing Our Strength study is being conducted to help us understand people's experiences     with hematopoietic stem cell transplantation and to test a new program designed to help     people recover physically and emotionally after transplant.   "
217742|NCT00695786|"     The goal of this clinical research study is to learn if revlimid (lenalidomide) in     combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma can     control the disease. The safety of this combination will also be studied.   "
217576|NCT00701688|"     Mucositis is a well-known complication of both autologous and allogeneic hematopoietic stem     cell transplantation (HSCT). Many who suffer this disorder require total parental nutrition     and intravenous narcotics for pain control. Palifermin (Kepivance[TM]) is a human     keratinocyte growth factor that is produced by recombinant DNA technology in E. coli.     Palifermin is a FDA-approved, commercially available pharmacologic agent that is manufactured     by Amgen. As keratinocyte growth factor receptors have been found within the epithelium of     gastric mucosa, the use of palifermin has been proven to decrease the frequency and duration     of severe mucositis in adult studies. Whereas the appropriate dosing regimen has been     determined for adults at 60mcg/kg/day, the dosing of palifermin has not been established in     the pediatric setting. This initial pediatric study of palifermin will determine the maximum     tolerated dose, evaluating the use of this agent at three dose levels, below, at, and above     the recommended adult dose. Non-hematologic, life-threatening NCI grade IV or grade V     toxicities definitely related to the administration of palifermin from the first infusion     until day +6 after HSCT (post palifermin administration day +3) will comprise the safety     endpoints of the study.      The study is designed to evaluate palifermin at 3 dose levels. The study population will be     recipients of either a matched family member donor or matched unrelated donor HSCT. The     pharmacokinetics of palifermin at each dose level will be described to help determine the     appropriate dose for future studies, which will evaluate efficacy   "
217577|NCT00701701|"     An exploratory, open-labeled study of patients with Pompe disease, who have previously     received Myozyme (alglucosidase alfa) treatment, to evaluate the efficacy, safety and     clinical benefit of 2 Immune Tolerance Induction (ITI) regimens in combination with Myozyme.     Eligible patients who are currently receiving Myozyme therapy will be enrolled into the     study, and will be followed for a minimum of 18 months on-study (a 6-month ITI treatment     module and a 12-month follow-up module on Myozyme alone). Eligible patients will be followed     for a minimum of 18 months on treatment or, if a patient is <6 months of age at the time of     enrollment, until the patient is 2 years of age. Both cross-reacting immunologic material     (CRIM)-negative and CRIM-positive patients can be eligible for Regimen A depending if they     meet the required criteria. Regimen B however, is limited to CRIM-negative patients.   "
217578|NCT00701714|"     This is a randomized, controlled, double-blind, multicenter multinational safety study     involving about 300 predialysis patients aged 18 years or above suffering from anemia.      Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to     achieve a hemoglobin target range of 10.0 -12.0 g/dL.   "
217579|NCT00701727|"     This is a prospective, placebo-controlled, cross-over trial comparing the the effects of     approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) treatment on     several parameters of reverse cholesterol transport (RCT) in men and post-menopausal women     diagnosed with hypercholesterolemia. The primary hypothesis is that the ezetimibe treatment     will increase the excretion of endogenous (plasma-derived) cholesterol as fecal sterols, with     secondary hypotheses that there will be a significant increase in de novo cholesterol     synthesis, treatment will increase cholesterol efflux from tissues into the bloodstream, and     increase global RCT.   "
217580|NCT00701740|"     A clinical and histological randomized controlled phase II trial to evaluate the efficacy and     safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or     sterilized women aged 40-55y. The subjects were included in two randomly selected groups: A-     21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen SPF 60 during three     months; B- 11 women received only same moisturizer/sunscreen.   "
217581|NCT00701753|"     An individual's genetic make-up is known to determine their response to antipsychotic     medication. Genetic markers that determine efficacy and side effects of medication may be     identified and used to predict treatment outcome.      The study is a naturalistic study of routinely prescribed antipsychotics using outcome     measures undertaken as part of the routine clinical care of the cohort. These clinical data     are linked with genetic information obtained from DNA and RNA from blood samples undertaken     as part of the study.      No alteration is made to the subjects treatment regime or medication.      The study is a two stage investigation:        -  The first stage involves the collection of a databank of clinical information and blood          samples for DNA and RNA extraction from patients treated with antipsychotic medication.        -  The second stage is a molecular genetic investigation of treatment-related genetic          factors that may contribute to response prediction and predisposition to side effects.      From these genetic studies pharmacogenetic prediction tests will be validated and/or     developed.   "
217583|NCT00701779|"     This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg),     administered once daily for one year in combination with Tamsulosin (0.4mg), administered     once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as     needed basis, on the improvement of symptoms and clinical outcome in men with moderate to     severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9     months), the subject will be counseled on withdrawal of Tamsulosin. After randomization,     study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic     visits)   "
217584|NCT00701792|"     Liver transplantation has been universally recognized to improve survival of patients     suffering from end-stage (Pugh C) alcoholic cirrhosis. However, for Pugh B patients, the     benefit of liver transplantation remains to be demonstrated. The aim of the present study was     to compare the outcome of Pugh B patients with alcoholic cirrhosis randomly assigned for     immediate liver transplantation (group 1) or standard treatments (group 2).   "
217585|NCT00701805|"     The purpose of this study is to evaluate the long-term safety of paricalcitol injection.     Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in     dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309     (NCT00667576).   "
217600|NCT00702000|"     To better understand ICU-acquired weakness in patients requiring mechanical ventilation in     the Intensive Care Unit.   "
217589|NCT00701857|"     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may make     tumor cells more sensitive to radiation therapy. Giving pemetrexed together with cisplatin     and radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when     given together with cisplatin and radiation therapy in treating patients with stage III or     stage IV esophageal cancer or gastroesophageal junction cancer.   "
217590|NCT00701870|"     TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra     treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung     cancer receiving first‑line therapy with carboplatin and docetaxel.   "
217591|NCT00701883|"     A Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy,     safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin     resistance and obesity in overweight, hyperlipidemic patients, both as monotherapy and in     combination with Atorvastatin      Total participation for each patient is approximately 16-17 weeks, which may include up to a     2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up.     During the run-in period patients taking statins, statin combination or Zetia will undergo a     'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their     same diet prior to entering the study). They will be asked to defer initiating any weight     loss diets or meaningful changes in their activity level until after they have completed the     study. Once randomized into the double blind study, patients will visit the clinic every two     weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the     double-blind study medication will be discontinued. Patients will attend a follow up visit     two weeks after their final dose for safety evaluation.   "
217592|NCT00701896|"     People that are infected with HIV appear to be especially susceptible to the adverse effects     of cigarette smoking. The purpose of this study is to determine if quitting smoking by using     a specialized smoking cessation treatment can prevent one from developing accelerated lung     damage, particularly emphysema.   "
217593|NCT00701909|"     This is a randomized double-blind study to determine if the administration of a small-dose of     ketamine (an anesthetic)added to morphine (an opioid) contributes to reducing pain intensity     during open wound care procedure (WCP)in patients who have had a traumatic injury and are in     an Intensive Care Unit. Patients will be randomized to receive morphine plus saline (a     placebo) or morphine plus ketamine before the WCP. The second time the patient is scheduled     for WCP (no less than 24 hours), patients will be crossed over to receive the treatment they     did not receive the first time. It is hypothesized that patients who receive the combination     of morphine and ketamine will have better pain control during the procedure than patients who     just receive morphine.   "
217594|NCT00701922|"     The present study was conducted to study the impact community acquired respiratory virus     (CARV) infections in an outpatient setting on graft function of lung transplant recipients.     The study was aimed to identify risk factors for CARV infections.      The study was further intended to investigate an association of Epstein-Barr virus (EBV),     cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify     risk factors for virus detection in blood.   "
217595|NCT00701935|"     A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of     twice-daily subcutaneous injection with exenatide versus treatment with matching placebo     injection on abdominal visceral fat content.   "
217596|NCT00701948|"     This study aims to evaluate new dosage of inflammatory markers or new inflammatory markers     for the diagnosis of nosocomial bacterial infection. We made the hypothesis that these new     dosages or new inflammatory markers could be more useful than dosage of inflammatory markers     already used in clinical practice (especially the use of a combination of interleukins (6 or     8) and C-reactive protein for the management of newborns with a clinical suspicion of     nosocomial bacterial infection and especially could allow to avoid excessive treatment with     antibiotics   "
217633|NCT00694343|"     The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal     hypotension in women undergoing spinal anesthesia for cesarean section   "
217634|NCT00694356|"     This clinical study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity     of dalotuzumab (MK-0646) in participants with relapsed or refractory locally advanced or     metastatic solid tumors using once weekly and once every other week dose infusion regimens.      The primary study hypothesis is that administration of dalotuzumab as a once weekly and an     every other week infusion will be generally safe and well tolerated   "
219193|NCT00719537|"     This study investigates whether low dose aspirin combined with progesterone will decrease the     risk of preeclampsia in pregnant women with a history of preeclampsia in a previous     pregnancy.   "
217597|NCT00701961|"     Malaria in pregnancy is a major public health problem in Sub-Saharan Africa. Over the past     decades, P. falciparum has shown increasing resistance to chloroquine and     Sulphadoxine-Pyrimethamine, which has prompted a change in treatment approach; artemisinin     containing combination therapies (ACTs) are now the standard treatment of P. falciparum     malaria in areas with established resistance to traditional therapies. However, a standard     approach for using ACT in pregnancy does not exist in Africa, where some countries keep on     using quinine, while others allow the use of ACTs. Thus, there is need of establishing the     safety and efficacy of ACTs in malaria-infected pregnant women. Since the pharmacokinetic of     antimalarials may be altered during pregnancy and since available pharmacokinetic data are     still somewhat limited, we propose to carry out a study confirming or disproving existing     pharmacokinetic data (collected in South-East Asia), before starting any larger African     efficacy and safety trials. The fixed-dose combination mefloquine-artesunate (MQ-AS),     developed by the Drugs for Neglected Diseases Initiative, will be used in the study, which     will compare the pharmacokinetics of MQ-AS for treatment of P.falciparum in 24 pregnant women     in the second and third trimesters, to the pharmacokinetics of this regimen in 24 matched     non-pregnant P.falciparum infected women. The study will be carried out in Burkina Faso.   "
217598|NCT00701974|"     Skin ulcers can be defined as open injuries, loss of substances with the skin or mucous     tissue, caused by disintegration and tissue necrosis. Chronic skin ulcer is any injury that     heal in a period not less than 6 weeks. Several etiological causes for the emergence of skin     ulcers. Around 73% are venous, arterial are 8%, 3% are diabetic, 2% are traumatic and 14% are     from other causes.      Clinical studies show that collagenase is an effective drug and presents high tolerabildade     in the treatment of ulcerative burns and injuries of various etiologies. Evidence show     statistically significant reduction of inflammation, the formation of granulation tissue,     decrease in injuries and reepitelization.   "
217599|NCT00701987|"     A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four     weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic     melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on     histological remission of cutaneous metastatic melanoma and induction of apoptotic     biomarkers.   "
217603|NCT00702039|"     Multiple studies in various specialties, including ophthalmology, are reported in the     literature that show that playing music during a procedure (dubbed music therapy) increases     patient satisfaction and may reduce patient anxiety and stress levels.      There is no study in the literature that assesses the effects of listening to music in     patients undergoing intravitreal injections. This study aims to assess whether listening to     music improves patient satisfaction or reduces their anxiety levels in subjects undergoing     intravitreal injections.   "
217604|NCT00702052|"     This study is to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in     patients with Mantle Cell Lymphoma who are refractory or intolerant to Velcade® therapy and     who have received at least one prior antineoplastic agent other than Velcade®, either     separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade®     therapy is determined by the study investigator based on clinical evaluations. Patients are     considered refractory to Velcade® if they have documented radiological progression on or     within 12 months of the last dose of Velcade® when given alone or, on or within 12 months of     the last dose of the last component of a combination therapy which included Velcade®.   "
217605|NCT00702065|"     This is a multi-center, multi-regional observational,24 month study.      Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be     collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health     outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.   "
217606|NCT00702078|"     We want to improve the treatment of patients suffering from COPD (3-4) by early medical     intervention in the patients home. A close cooperation between the hospital and the primary     healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality     of life. Following up from the hospital and the primary healthcare in cooperation may lead to     earlier detection and treatment of exacerbations in COPD.      The main outcome variable will be number of hospitalizations assessed simply by counting. The     second objective will be Quality of life and activation assessed by different questionnaires     included in St.George´s Respiratory Questionnaire.   "
217607|NCT00702091|"     The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under     fasting conditions.   "
217608|NCT00694018|"     The objective of this study was to assess whether an Internet-mediated pedometer based     intervention would increase walking and improve function among individuals with chronic back     pain.   "
217609|NCT00694031|"     Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional     hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and     a sample size of around 750 will be necessary to detect a 35% reduction in mortality.   "
217610|NCT00694044|"     1. Characterize the tolerability and safety of repeated doses of varenicline in healthy          non-smoking elderly subjects.        2. Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly          subjects.        3. Evaluate the potential effects of repeat doses of varenicline on cognition in healtly          non-smoking elderly subjects.   "
217611|NCT00694057|"     This is a phase II, double-blind, randomized, placebo-controlled study of the safety,     tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients     receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or     placebo) for a treatment period of 12-weeks.   "
217612|NCT00694070|"     The purpose of this study is to evaluate a diabetes data management program in the hands of     potential users, both health care professionals and lay users.   "
217613|NCT00694083|"     A clinical study evaluates the safety, tolerability, and pharmacokinetics of ridaforolimus     (MK-8669) in participants with locally advanced or metastatic solid tumors.   "
217635|NCT00694369|"     The purpose of this study is to compare the pain relieving effect of different doses of     MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental     pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and     patient evaluation.   "
217614|NCT00694096|"     This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments in     20 evaluable patients with metastatic renal cell cancer (RCC) and an early post therapy     assessment at baseline and at various early time points (1 week in 5 patients, 2 weeks in 5     patients, 3 weeks in 5 patients and 4 weeks in 5 patients) after institution of standard     approved sunitinib therapy at 37.5 mg/day. The clinical imaging biomarkers will include an     assessment of tumor metabolism [Bannasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005,     Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A,     Weber 1977B] (dynamic FDG-PET); tumor proliferation [Rasey 2002,Shields 2001, Shields 1998,     Vesselle 2002, Schwartz 2003] (dynamic FLT-PET); tumor blood flow (H215O-PET, DCE MRI)[Lodge     2000], tumor perfusion (DCE-MRI)[Tofts 1999, Tofts 1997, Parker 1999]; and tumor blood volume     (H215O-PET, DCE MRI)[Lodge 2000, Tofts 1999, Tofts 1997] in the same patient at baseline and     then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or     4 weeks). We hypothesize that by using this set of imaging assessments it will be possible to     determine an individual or more likely a set of imaging derived biomarkers that will     accomplish several of the goals of the initiative which is providing funding for the study.   "
217615|NCT00694109|"     To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in     participants with familial hypercholesterolemia or severe hypercholesterolemia on     lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7     (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials.   "
217616|NCT00694122|"     1. To investigate the effect of insulin glargine (Lantus™) vs NPH insulin regarding          glycemic control during the early AM (dawn phenomenon) in individuals with type 1          diabetes.        2. To measure hormones implicated in the pathogenesis of the dawn phenomenon in individuals          with type 1 diabetes.   "
217617|NCT00694135|"     The purpose of this study is to define a safe and effective dose of iontophoretic delivery of     dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in     patients with non-infectious anterior segment uveitis.   "
217618|NCT00694148|"     NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the     muscle, NT 201 causes a reversible local relaxation of the injected muscle. Botulinum toxin     type A is widely used for aesthetic treatment of mimic wrinkles. This study will investigate     the safety and efficacy of NT 201 in the treatment of glabellar frown lines.   "
217619|NCT00694161|"     Open-label, multicenter, international, single-treatment study designed to determine TTR     stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical     outcomes in patients with V122I or wild-type TTR amyloid cardiomyopathy.      The study will be conducted in two parts. Part 1 will include a six-week dosing period during     which all enrolled patients will self-administer oral Fx-1006A 20 mg soft gelatin capsules     once daily for six weeks. At Week 6, blood samples will be collected from each patient to     determine TTR stabilization. Patients who complete the Week 6 visit will continue taking     daily oral Fx 1006A 20 mg for up to a total of 12 months during Part 2 of this study. If it     is determined that a patient is not stabilized at Week 6 (based on TTR stabilization data),     the patient will be discontinued from the study. Safety and clinical outcomes will be     evaluated during Part 2 of this study.      Two whole blood samples for pharmacodynamic assessments (TTR stabilization) and     pharmacokinetic assessments (Fx-1006A concentrations as well as calculated steady-state     parameters) will be collected at Baseline and Week 6. At Months 6 and 12, two whole blood     samples will be collected for pharmacodynamic assessments, and four whole blood samples (two     samples per time point) will be collected for pharmacokinetic assessments to be utilized in     population pharmacokinetic modeling.      Echocardiography, chest x-ray, cardiac MRI, and 24-hour Holter monitoring will be conducted     at Baseline, and Months 6 and 12. Six-minute walk test and quality of life utilizing the     Patient Global Assessment, KCCQ, and SF-36 will be assessed at Baseline, and Months 3, 6, and     12. NYHA Classification will be assessed at Baseline, Week 6, and Months 3, 6, and 12. Serum     markers of troponin I and T, and NT-pro-BNP levels will be assessed at each study visit.      Safety and tolerability will be assessed throughout the study. Vital signs, 12-lead ECG,     blood and urine samples for clinical laboratory tests (serum chemistry, hematology,     coagulation panel, and urinalysis), AEs, and concomitant medications (including diuretic     usage) will be assessed at each study visit. Abbreviated physical examinations will be     conducted at Baseline, Weeks 2 and 6, and Months 3 and 6, and a complete physical examination     will be conducted at Month 12.      Clinic visits will be conducted during Screening (Days -30 to -1) and Baseline (Day 0);     procedures scheduled for the Baseline visit may be conducted over a period of one week to     accommodate patient scheduling. All Baseline procedures must be completed prior to the first     self-administered dose on Day 1. Day 1 will be defined as administration of the first dose of     study medication, which patients will self-administer at home. During treatment, clinic     visits will be conducted at Week 2 (± 2 days), Week 6 (± 1 week), Month 3 (± 1 week), Month 6     (± 2 weeks), and Month 12 (± 2 weeks). Procedures scheduled for the Month 6 and 12 visits may     occur over one week during the visit window to accommodate patient scheduling. Monthly     telephone contacts (± 1 week of the scheduled date) will be made during months in which no     clinical site visits are scheduled (Months 4, 5, 7, 8, 9, 10, and 11) for assessment of AEs     and concomitant medications. A final telephone contact to assess AEs and concomitant     medication usage will be made 30 days after the last dose of study medication for each     patient.      Patients who discontinue from the study at any time will have a final visit performed,     including all safety assessments, at the time of discontinuation. Any patient discontinuing     after the Month 6 visit will also have all exploratory assessments performed.   "
217620|NCT00694174|"     The purpose of this study is to assess whether an instrument, the Laser Doppler Imager, is     able to measure the effect of pain related changes in skin blood flow in newborn infants. The     study will also determine whether the use of sucrose (sugar water) when given by mouth has     any effect on pain related skin blood flow changes.   "
217621|NCT00694187|"     The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon     Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design   "
217622|NCT00694200|"     To evaluate the efficacy of metronomic oral vinorelbine taken three times a week without     break plus bevacizumab as salvage treatment in patients with metastatic breast cancer.   "
217623|NCT00694213|"     The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled     in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations     with the Biojector® 2000, and will be followed for 6 months to evaluate the safety of and the     immune system's response to the vaccine. The safety and immune system's response will be     studied throughout the trial.   "
217624|NCT00694226|"     The objective of the study was to assess the efficacy in decreasing the likelihood of     substance use of a brief motivational enhancement intervention in adolescents referred to     psychiatric treatment.      237 adolescents consecutively admitted to a psychiatry department completed an evaluation of     their substance use. Subjects identified as users were randomly allocated to one of two     groups: an experimental group that received a brief intervention aimed at increasing their     awareness of the risks of substance use, or a control group. All subjects received standard     treatment according to the primary diagnosis. Structured questionnaires assessing knowledge,     attitudes, perception of risks and intention of use of psychoactive substances were     administered upon admission and 1 month later.   "
217625|NCT00694239|"     The RATCHET study assesses if patient knowledge of estimated cardiovascular risk at current     and recommended target blood pressure levels improves compliance in the management of     hypertension.   "
217626|NCT00694252|"     This study will evaluate the efficacy of lapatinib in eradicating chemo- resistant tumour     cells circulating in the blood of patients with breast cancer.   "
217627|NCT00694265|"     In wrists with carpal tunnel syndrome (CTS) the sonographically measured largest     cross-sectional area (CSA) of the median nerve is increased. We compared the changes in     largest CSA in wrists undergoing surgical decompression and wrists undergoing conservative     treatment of CTS.   "
217628|NCT00694278|"     The aim of this study and the primary outcome is to clinically evaluate effect of     laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. Secondary outcomes will     evaluate CCK, FFA, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Patients will be     followed closely to ensure the desired results are sustained in long term   "
217629|NCT00694291|"     The purpose of this study is to measure the benefit of sorafenib in patients with a rising     PSA after treatment with radiation therapy or surgery who are NOT receiving with androgen     ablation therapy.   "
217630|NCT00694304|"     The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine     over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed     8-week acute treatment.   "
217631|NCT00694317|"     The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon     Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fed conditions using a     single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design   "
217632|NCT00694330|"     This research study is testing the safety of a vaccination of cells called GM-K562 cells     mixed with the participants own irradiated tumor cells. The GM-K562 cells have been modified     in the laboratory to secrete the protein GM-CSF. This protein can be effective in stimulating     an immune response to cancer. This newly developed vaccine may stop cancer cells from     growing.   "
217636|NCT00694382|"     The primary objective was to compare the efficacy of once daily subcutaneous injections of     Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE]     in cancer patients at high risk for VTE and who were undergoing chemotherapy.      The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to     document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of     VTE and to assess the survival status at one year in this population.   "
217637|NCT00694395|"     To identify the circumstance during decision making processes to seek medical help in     patients with symptoms of acute ischemic stroke.   "
217638|NCT00694408|"     Objective:      The overall objective is to investigate whether a steroid free immunosuppressive regimen is     as safe and effective as a steroid containing regimen following pediatric liver     transplantation and whether it promotes tolerance.   "
217639|NCT00694421|"     This study will test the hypothesis that constitutionally poorer Eustachian tube function     predisposes to middle-ear pathology during a viral upper respiratory infection.   "
217640|NCT00694434|"     Evaluation of embryo quality in the fresh cycle as a predictor of outcome from frozen embryo     transfer.   "
217641|NCT00694447|"     The hypotheses of this study are: In the older population with knee OA,        -  When acupoints are chosen for both sleep and pain, there are additive effects on sleep          improvement and pain relief (i.e. no interaction).        -  Main effects of acupuncture on sleep improvement and pain relief are anticipated when          acupoints are separately targeted for sleep and for pain, respectively.   "
217642|NCT00694460|"     This study evaluated the safety and immunogenicity of rabies vaccine and Japanese     encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies     vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis     vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic     when administered concomitantly to toddlers.   "
217643|NCT00694473|"     We hypothesize that measurements of interstitial fluid (ISF) glucose by the FreeStyle     Navigator (Abbot Diabetes Care), a continuous glucose monitoring system, will correlate with     blood glucose (BG) values in surgical and ICU patients with a clinically useful degree of     accuracy.   "
217644|NCT00694486|"     This study will compare Eustachian tube function (ETF) testing in adults with intact tympanic     membranes (TM) using a pressure chamber to that obtained using standard methods requiring a     non-intact TM.   "
217645|NCT00694499|"     Little is known about the role of collateral damage in patients with high grade liver     injuries (LI). This retrospective single centre study investigates the safety of the     non-operative management of patients with high grade blunt liver injuries (NOMLI) and the     impact of to the LI collateral intra- and extra-abdominal damage on interventions and     outcome. We first hypothesized that NOMLI can be safely achieved also in high-grade liver     injured patients, the management of trauma patients with LI mainly consist of the treatment     of collateral damages and their complications, and causes of death are in the majority of     cases not liver related. A retrospective study involving 183 patients with blunt hepatic     injuries was therefore carried out to investigate these hypotheses.   "
217646|NCT00694512|"     The purpose of this study is to learn more about how diet affects the hormone ghrelin.     Ghrelin is made in the stomach and causes appetite to increase. Learning about ghrelin will     help the investigators understand more about obesity.   "
217647|NCT00694525|"     21-hydroxylase deficiency (21-OHD) is an inherited disorder that results from a mutation on     the CYP21A2 gene. It affects the adrenal glands and is the most common cause of congenital     adrenal hyperplasia (CAH). 21-OHD CAH causes the body to produce an insufficient amount of     cortisol and an excess of androgen, the type of hormone that produces male characteristics.     The primary treatment for 21-OHD CAH, glucocorticoid replacement therapy, has been shown to     cause bone loss. However, the elevated hormone levels caused by 21-OHD CAH may increase     production of the protein osteoprotegerin (OPG), which in turn may protect against bone loss.     This study will compare bone density and OPG levels in women who have 21-OHD CAH and have     undergone a lifetime of glucocorticoid replacement therapy to that in women who have neither     of these criteria. In doing so, the study will aim to determine the relationship between OPG     and bone loss.   "
217648|NCT00694538|"     The purpose of this study is to determine the advantages of the interferential laser therapy     in shoulder pain reduction compared with the conventional low level laser therapy modality.   "
217649|NCT00694551|"     Pilot Immunotherapy Study of Combination Prostate Specific Membrane Antigen (PSMA) and T-cell     receptor γ alternate reading frame protein (TARP) Peptide With Poly IC-LC Adjuvant in Human     Leukocyte Antigens (HLA)-A2 (+) Patients With Elevated prostatic specific antigen (PSA) After     Initial Definitive Treatment      The purpose of the study is to see if the PSMA/TARP proteins in the vaccine, along with the     Hiltonol, can arouse and train the immune system to kill the prostate cancer cells. Prostate     cancer is the most common cancer and is the second leading cause of cancer deaths in U.S.     males. It is curable when it is confined to the prostate (kept from spreading) using surgery     or radiation treatments. In some patients the cancer can come back after these treatments.     Treatment options for prostate cancer that comes back include procedures or medications which     may have significant risks and side effects. Another plan is being looked at that uses the     body's immune system to attack prostate cancer cells. A vaccine has been developed that has     proteins found in prostate cancer cells. One of the proteins is called PSMA and the other is     called TARP. In addition to these proteins, another substance called Poly IC-LC (Hiltonol)     will be added to the vaccine to boost its ability to start the immune system.   "
217650|NCT00694564|"     This pilot study will investigate the efficacy of SAM-e for the treatment of recurrent     abdominal pain in children. This will be an open-labeled study and all participants will     receive SAM-e therapy. Given that SAM-e has been demonstrated to improve symptoms of     depression and pain with minimal side effects as compared to other antidepressant therapy, we     hypothesize that SAM-e will reduce pain symptoms among children with recurrent abdominal     pain.   "
217651|NCT00694577|"     The purpose of this study is to determine the feasibility of partial breast irradiation in     participants with early invasive or non-invasive breast cancer.   "
217843|NCT00702975|"     A phase II study of combination therapy of carboplatin -gemcitabine plus bevacizumab beyond     progression in patients with locally advanced and/or metastatic non-small cell lung cancer     (NSCLC) who have not received prior chemotherapy.   "
217652|NCT00694590|"     The purpose of this research study is to determine if plerixafor can make CLL/SLL (Chronic     Lymphocytic Leukemia/ Small Lymphocytic Lymphoma) cells more sensitive to being killed by     rituximab, an anti-cancer drug that is commonly used in treating CLL and SLL. In this study,     plerixafor will be added to standard treatment with rituximab. Subjects will be monitored to     see how well they tolerate the use of these drugs together and how well they work to treat     the leukemia.      The primary objective is to determine the maximum tolerated dose (MTD) of plerixafor when     combined with rituximab as treatment for previously treated patients with CLL or SLL.   "
217653|NCT00694603|"     The purpose of this research study is to find out how well cetuximab works in treating NSCLC     in patients who have been previously treated with a class of drug called tyrosine kinase     inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells     called epidermal growth factor receptor or EGFR. EGFR helps cancer cells grow.   "
217654|NCT00694616|"     Metabolic syndrome is a constellation of risk factors for cardiovascular disease. The     prevalence of metabolic syndrome in persons with obstructive sleep apnea syndrome (OSAS) is     known to be very high, about 70%. However, it is unclear whether this association is causal     or not. Results of earlier studies have been conflicting. The investigators hypothesize that     treatment with auto-titrating continuous positive airway pressure (auto-CPAP) for a duration     of 3 months improves the metabolic syndrome in subjects with OSAS.   "
217655|NCT00694629|"     Protocol Synopsis The goal of this Phase 2 clinical trial is to evaluate the antimicrobial     activity and safety of an experimental intensive phase (first 8 weeks of treatment)     tuberculosis treatment regimen in which rifapentine is substituted for rifampin.      Primary Objective        -  To compare the antimicrobial activity and safety of standard daily regimen comprised of          rifampin (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE) to          that of an experimental regimen comprised of rifapentine (approximately 10 mg/kg/dose) +          isoniazid + pyrazinamide + ethambutol (PHZE).      Secondary Objectives        -  To determine and compare for each regimen the time to culture-conversion, using data          from 2-, 4-, 6-, and 8-week cultures (10, 20, 30, 40 doses).        -  To determine and compare for each regimen the proportion of patients with any Grade 3 or          4 adverse reactions        -  To determine the correlation of the MGIT/BACTEC liquid culture growth index and other          mycobacterial and clinical biomarkers with time to culture conversion and treatment          failure        -  To store serum for future assessment of biomarkers of TB treatment response and          hypersensitivity to study drugs.        -  To compare adverse events and 2-month culture conversion rates among HIV-infected          patients vs. HIV-uninfected patients        -  To determine the tolerability and safety, and estimate the antimicrobial activity, of          experimental regimens that include isoniazid + pyrazinamide + ethambutol plus either          rifapentine 15 mg/kg/dose or rifapentine 20 mg/kg/dose, all administered daily.          Assessment of these doses of rifapentine will be performed as an extension to the main          study after enrollment in the main study has been completed.      Design      This will be a prospective, multicenter, open-label clinical study. Adults suspected of     having pulmonary tuberculosis who meet eligibility criteria will be randomized to receive     either the experimental intensive phase tuberculosis treatment regimen or the standard     intensive phase tuberculosis treatment regimen. Randomization will be stratified by     presence/absence of cavitation on baseline chest radiograph, and by geographic continent. All     doses of study drugs will be given under direct observation and administered 5 days per week.     After a subject completes intensive phase therapy, he/she then will be treated with a     non-experimental continuation phase tuberculosis treatment regimen.      The study extension will be a prospective, multicenter clinical trial. Eligibility criteria     will be the same as for the main study. Participants will be randomized to one of four     regimens: the standard intensive phase treatment regimen, an investigational regimen in which     rifapentine 10 mg/kg/dose is substituted for rifampin, an investigational regimen in which     rifapentine 15 mg/kg/dose is substituted for rifampin, or an investigational regimen in which     rifapentine 20 mg/kg is substituted for rifampin. Randomization will be stratified by the     presence/absence of cavitation on baseline chest radiograph, and by study site. Study drugs     will be administered 7 days per week. After a subject completes intensive phase therapy,     he/she then will be treated with a non-experimental continuation phase tuberculosis treatment     regimen. Subjects will have blood drawn for one pharmacokinetic determination of rifapentine     concentration at or after the week 2 visit during intensive phase therapy.      This study is being conducted in 2 phases.        1. The main study compares a 10 mg/kg dose of rifapentine, open label, against 10 mg/kg          rifampin in an otherwise standard intensive phase regimen of treatment for pulmonary          tuberculosis. The projected sample size was 480 enrollments; 530 patients were actually          enrolled.        2. The study extension evaluates higher doses of rifapentine, with the specific rifapentine          doses (10 mg/kg, 15 mg/kg, and 20 mg/kg) blinded to patients and clinicians, with data          collection and endpoints otherwise similar to the main study. The projected sample size          for the study extension is 320 enrollments.   "
217656|NCT00694642|"     The purpose of this study is to determine whether transendocardial injections of autologous     endothelial progenitor cells CD 133 is safe and feasible in patients with refractory angina.   "
217657|NCT00694655|"     The objective of this study is to study immune memory generated against the yellow fever     vaccine (YFV) in participants who recently received the YFV vaccine. Volunteers who are     planning to travel to yellow fever endemic areas will be recruited into this study.     Volunteers will receive the yellow fever vaccine at the Hope Clinic of Emory University or at     their private health care provider's office. Blood tests will be drawn before the vaccination     and at upto 8 visits following vaccination. A volunteers's study participation may will last     as short as 1 month or as long as one year depending on the immune responses.      We plan to compare the immune responses in younger people (18 to 45 years) to that of older     people (55 or above).   "
217658|NCT00694668|"     Background:      In recent years, there has been a marked rise in the frequency of young people engaging in     Deliberate Self-Harm (DSH). DSH refers to all kinds of self-harming behaviour, with and     without suicidal intent. Early identification and treatment of persons who engaged in DSH is     important because every episode of DSH increases the risk of future episodes and, eventually,     suicide. A number of comprehensive treatment programs have been developed and proven to be     effective in reducing DSH in adults. Especially the modification of inadequate emotion     regulation strategies seems to be essential in the prevention of future episodes of DSH. The     first short-term results of a Dutch time-limited and structured individual     cognitive-behavioral treatment (CBT) for DSH in adolescents and young adults also showed     positive effects on repetition of DSH and associated problems.      Objective:      To study the effects and costs of the total individual CBT package and one of the components     of the total CBT treatment package (i.e. mindfulness training) in a group format compared to     Treatment-as-Usual (TAU) on the short and long term.      Design:      Multi-center randomized controlled clinical trial with repeated measurements at baseline     (M0),and posttreatment (M6)), 12 (M12) and 18 months (M18) after baseline.      Procedure:      Young persons aged 15-35 who recently have engaged in DSH and have been referred to the     Leiden University Medical Centre, the mental health centre Rivierduinen or the University     Medical Centre St. Radboud following an act of DSH will be invited to participate. Persons     reporting severe psychiatric disorders requiring intensive inpatient treatment or serious     cognitive impairments will be excluded.      Interventions:      Participants are randomly allocated to CBT, Mindfulness-Based Cognitive Therapy(MBCT) or     Treatment-as-Usual (TAU). The CBT treatment consists of up to 12 weekly sessions of     individual treatment mainly consisting of emotion regulations skills, cognitive     restructuring, and behavioural skills training. The MBCT training consists of 8 2-hour     sessions in a group format within a three months time frame.      Outcome measures:      The same outcome measures to assess the clinical effects of treatment as in the previous     study will be used (repetition of DSH, depression (BDI-II), anxiety (SCL-90),     self-concept(RSC-Q), and suicide cognitions (SCS)) allowing a historical comparison of     treatment effectiveness across both randomized clinical trials. In addition at all     assessments health-related quality of life, use of medical resources and loss of productivity     will be assessed (EuroQol, VAS and TTO). In addition,problems in emotion regulation (an     important risk mechanism for repetition of DSH) will be assessed before and after treatment.      Economic evaluation:      Differences in societal costs (intervention, other (health) care and productivity)will be     compared to differences in the frequency of DSH and quality adjusted life years (EuroQol, VAS     and TTO).      Data-analysis/power:      Based on our previous study at least a medium effect of treatment on repetition of DSH may be     expected. Assuming a medium effect of one of the treatments compared to TAU (delta =.75) and     an attrition rate of about 20 %, at least 42 patients per study arm are needed to detect a     minimal clinical relevant difference in repetition of DSH with a power of 80% and alpha set     at .05.   "
217659|NCT00694681|"     Working toward Wellness is a telephone care management and outreach monitoring program     designed to help Medicaid recipients who are experiencing major depression to enter and     remain in evidence-based treatment. To study the effects of Working toward Wellness,     individuals receiving Medicaid in Rhode Island who are eligible for mental health services     through United Behavioral Health were screened by telephone for depression. Those who were     found to have major depression and who agreed to be in the study were randomly assigned.     Program participants received intensive monitoring from Master's level clinicians called care     managers to facilitate and support clinical treatment. The control group received usual care     that included only referrals to mental health treatment providers. The study hypothesis is     that telephonic care management would increase visits to mental health professionals and use     of appropriate medication, which in turn would reduce depression severity and lead to greater     employment and productivity at work.   "
217660|NCT00694694|"     This trial sets out to determine whether the combination of azithromycin and artesunate     (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania,     artemether-lumefantrine (AL). There are two reasons this is important        1. there are only a limited range of drug combinations which work against malaria in this          area of Tanzania        2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if          the combination is an effective antimalarial it might have a place where there are no          diagnostic facilities as syndromic treatment for fever.      Artesunate and azithromycin have both been used alone or in combination with other drugs in     children in Tanzania for many years, and are considered safe. There is trial evidence for the     effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory)     evidence that it works against the malaria parasite.      The trial randomizes children with non-severe malaria to the new combination AZ+AS or the     standard care arm AL. The primary outcome is the parasitological failure rate by day 28-     meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary     outcomes include safety.   "
217661|NCT00694707|"     This is an study to evaluate the safety, efficacy, and tolerability of RGH-188 relative to     placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.   "
217662|NCT00694720|"     The primary objective of this study is to assess the activity on breathing parameters of 4     escalating doses of AVE0657 in comparison to placebo in patients with Cheynes-Stokes     Breathing Syndrome.   "
217663|NCT00694733|"     The purpose of this study is to determine if estrogen or testosterone can affect cortisol     levels and where fat builds up in our bodies.   "
217664|NCT00694746|"     This trial will provide preliminary data to test the hypothesis that a six-month treatment     period with fish oil for overweight adolescent with mild to moderate persistent elevation of     ALT levels and presence of hepatic steatosis on CT-scan is safe and will result in decreased     ALT.   "
217665|NCT00694759|"     The purpose of this study is to determine if insulin resistance (how well the body uses     insulin and clears sugar) can affect cortisol levels in normal healthy women and women with     polycystic ovary syndrome of all body weights.   "
217666|NCT00694772|"     Removal of the adenoid and tonsils, known as an adenotonsillectomy (AT) is one of the most     frequently performed surgical procedures in North America. The two most prevalent indications     for this procedure in children are recurrent bacterial tonsillitis and obstructive sleep     apnea (OSA). OSA is a common childhood condition that is characterized by upper airway     obstruction, disturbed sleep and disrupted normal respiratory gas exchange. In the majority     of children with OSA, overgrowth of the adenoid and tonsils is the primary underlying     aetiology, making tissue removal via AT the standard of care. The purpose of this study is to     evaluate the effectiveness of two different surgical techniques, electrocautery-tonsillectomy     and coblation-tonsillotomy, in the treatment of obstructive sleep apnea (OSA) in children.   "
217667|NCT00694785|"     To evaluate the effect of ARC1779, a therapeutic oligonucleotide (aptamer) in patients with     Type2B von Willebrand Disease.   "
217668|NCT00694798|"     The primary purpose of this study is to evaluate the response rate of this treatment (Mw) in     patients with BCG refractory superficial transitional cell carcinoma. Other objectives     include detecting the effect of Mw on Time to Tumor progression and evaluating safety.   "
217669|NCT00694811|"     The primary objective of the study is to test the hypothesis that prolonged re-feeding after     VLED induced weight loss improves weight maintenance and eating behaviour   "
217670|NCT00694824|"     A not randomized , cross sectional study will be done to determine the possible association     of coronary artery calcification (CAC) score assessed by multirow spiral computed tomography     (MSCT) with specific and non specific uremic factor of vascular calcification.   "
217671|NCT00694837|"     The objectives of the trial are:      To assess safety, tolerability and activity of nelfinavir given neo-adjuvant and concomitant     to chemoradiotherapy with temozolomide in patients with a newly diagnosed glioblastoma     multiforme.      To describe the possible effect of nelfinavir on functional imaging To describe the activity     of nelfinavir in vivo on blocking the AKT pathway.   "
217736|NCT00695682|"     Injections of medicine into the middle of the eye (intravitreal injections) are commonly used     in a multitude of retinal diseases. We are looking for new treatments that may be beneficial     in treating retinal disease and improving patients' vision.      Infliximab (Remicade) is a genetically engineered antibody against a molecule in the body     called TNF-α. It neutralizes the effects of TNF-α by binding to it. Intravenous Infliximab     has been used for inflammatory arthritic conditions and Crohn's disease since 1998. We do not     know if infliximab injections into the eye are safe. We are performing this pilot study to     determine if they can be safe.   "
217672|NCT00694850|"     The purpose of this study is to assess multiple ascending doses of a new drug (BAY63-2521)     given orally, to evaluate if it is safe and can help to improve the well-being, symptoms     (e.g. disturbed breathing) and outcome of pulmonary hypertension associated with lung     fibrosis. Patients living with pulmonary hypertension associated with interstitial lung     disease have a risk of increased number of hospitalisations because of worsening of their     condition. Until now there is no approved medication for this disease. The current treatment     of pulmonary hypertension associated with interstitial lung disease consists: of oxygen and     medical treatment with vasodilators, e.g. so-called Calcium-antagonists. Therefore, there is     a need for new drugs in the treatment of pulmonary hypertension associated with interstitial     lung disease.   "
217673|NCT00694863|"     The purpose of this study is to determine whether treatment with long-acting synthetic     adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous     nephropathy and high for renal failure.   "
217674|NCT00694876|"     The purpose of this study is to determine how health literacy impacts glaucoma patient     adherence (as measured by following up with the doctor) in Tamil Nadu, India. We hypothesize     that individuals with better health literacy will have higher rates of follow-up with their     ophthalmologist.   "
217675|NCT00694889|"     The aim of this study is to investigate the efficacy of neuroscience-guided computerized     cognitive training exercises on the remediation of cognitive deficits and symptoms associated     with recent-onset schizophrenia and to examine the influence of subject characteristics,     brain structure and function, and pharmacotherapy on the response to remediation.   "
217676|NCT00694902|"     This study is the first administration of GSK610677 to man. The main aim of this clinical     study is to investigate the safety and tolerability of different doses of the investigational     medicinal product GSK610677. 2 cohorts of 8 subjects (Cohorts I and II) will be enrolled into     this study. Individual subjects in each cohort will have up to 3 treatment periods. In each     treatment period, subjects will receive a single inhaled dose of GSK610677 or placebo.     Predicted doses are: 10, 30, 50 100 250 and 500ug.For individual subjects in each cohort,     there will be a minimum wash out period of at least 10 days. In this period safety and     tolerability data will be collected prior to dose to the next level.After safety review     meetings between the site and the sponsor following the administration of the 500 ug dose, it     was decided to add an extra cohort (Cohort III) of 8 subjects and administer 1000µg. Each     subject in Cohort III will undergo a screening visit, one treatment period, and a follow up     visit.   "
217677|NCT00694915|"     The purpose of this study is to determine and compare the effect of this treatment on     recurrence rate and to assess the toxicity in both arms of patients with STCC. Other     objectives include determining the effects of this treatment on quality of life, and     comparing the effect of Mycobacterium w on time to tumor progression.   "
217678|NCT00694928|"     This study will evaluate the efficacy and safety of a vaginal product compared with that of     another vaginal product in the treatment of vaginal infections.   "
217679|NCT00694941|"     The objective of this study is to investigate the long term safety of ALS patients taking     ONO-2506PO.   "
217680|NCT00694954|"     The role of capsule endoscopy (CE) in patients with obscure / occult gastrointestinal (GI)     bleeding remains unclear. This pragmatic randomized controlled trial is designed to determine     the diagnostic yield and clinical outcomes of patients with obscure GI bleeding who receive     CE compared to those who receive usual standard care.   "
217681|NCT00694967|"     We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P)     will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared     to cerclage therapy. The purpose of this study was to compare medical therapy with 17P to     surgical therapy with transvaginal cerclage in patients with an ultrasound diagnosed short     cervix and funnel in the mid-trimester.   "
217682|NCT00694980|"     This is a randomized , double-blind, placebo-controlled study of approximately 70 patients     with ulcerative colitis.   "
217683|NCT00694993|"     This is a double-blind, placebo-controlled, randomized single dose escalation study and a     double-blind, placebo-controlled, randomised parallel group 14-days once daily repeat dose     study to investigate safety, tolerability and pharmacokinetics of an intranasal H1/H3 dual     antagonist compound in healthy male subjects.   "
217684|NCT00695006|"     To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR)     remain elusive. The purpose of this study was to compare the effects of manual therapy,     exercise, and cervical traction to manual therapy, exercise, and sham traction on pain,     function and disability in patients with CR.   "
217685|NCT00695019|"     The purpose of this study is to determine whether lozenges of interferon-alpha that are     dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who     had a complete virologic response after receiving a combination of injected interferon-alpha     and oral ribavirin.   "
217686|NCT00695032|"     RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is evaluating kidney damage in patients receiving cisplatin and     ifosfamide for solid tumors.   "
217687|NCT00695045|"     This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain     relief and side effect profiles of same in the setting of Total Knee Replacement.We     hypothesized that a dose greater than that used in Total Hip Replacement was needed and     wished to find a dose which was effective but had a low side effect profile.   "
217737|NCT00695695|"     This study will explore how caregivers adjust to having a child with Down syndrome.      Primary caregivers 18 years of age and older of a child with Down syndrome may be eligible     for this study. Participants complete a 20- to 30-minute survey that explores the subject s     thoughts and feelings about being a caregiver to a child with Down syndrome. Questions     explore the impact on the subject of being a caregiver for a child with Down syndrome, the     subject s uncertainties related to the child s condition and goals for the child related to     social skills, behavior, learning and education, physical and mental health, independence,     and other goals. It also asks questions about the caregiver, the family and the child with     Down syndrome.   "
217688|NCT00695058|"     During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in     pressure was observed in the external urethral sphincter along with an increase in bladder     capacity. In a subsequent study it was demonstrated that TMNS in women could induce pressure     increment of the external urethral sphincter. A pilot study have since shown that after 6     weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able     to contract their pelvic floor muscles and had become free of symptoms. Another pilot study     has shown promising effect on the overactive bladder syndrome.      The present study aims to treat urinary incontinence and includes 3 groups of patients with     40 patients in each group: Women suffering from urinary stress incontinence, women suffering     from urge incontinence and men suffering from urinary incontinence after a prostatectomy. A     medical vibrator is used and in each group the subjects will be randomized to active     treatment or placebo treatment.      In women the stimulation will be performed at the perineum every day for 6 weeks with an     amplitude of 2 mm and a frequency of 100 Hz. In men the vibration parameter/location will be     determined by the results of a pressure profile study also included. Results will be     evaluated on the basis of questionnaires, micturition diaries and diaper tests.      If we are able to demonstrate a significant reduction in the incontinence symptoms in the     subjects we asses that vibration can be a way of reestablishing a normal function of the     pelvic floor muscles and bladder function in incontinent patients.   "
217689|NCT00695071|"     The objective of this clinical trial is to document the steady state pharmacokinetics and     safety of a new itraconazole 200 mg film coated tablet.   "
217690|NCT00695084|"     This trial will evaluate whether progressive multiple sclerosis associated with hemiparesis     may benefit from Constraint-Induced Movement Therapy.   "
217691|NCT00695097|"     The aim of the study is to find out if Rituximab, which is an antibody against specific white     cells involved in rejection, when combined with standard anti-rejection treatment can more     effectively reverse the rejection process.      Our hypothesis is that with acute rejection there is activation of B cells and the subsequent     development of anti-donor antibodies that ultimately lead to graft loss. More effective     therapy targeted at B cells may abort the development of anti-HLA antibodies, prevent renal     injury and have a favorable effect on long-term graft outcome.   "
217692|NCT00695110|"     The purpose of this pharmacokinetic study is to determine whether oral testosterone ester     formulations can be used effectively to treat men with low testosterone.   "
217693|NCT00695123|"     This study will determine eligibility for participation in research studies on blood     disorders conducted by the National Heart, Lung and Blood Institute and the National     Institute of Diabetes, Digestive, and Kidney Diseases.      Healthy volunteers, patients with blood disorders under study by NHLBI and NIDDK and     potential stem cell donors for patients with blood disorders who are 8 years of age and older     may be eligible for this screening protocol. (Healthy volunteers who qualify for research     protocols would serve as control subjects.)      Participants undergo the following tests and procedures:      Healthy Volunteers        -  Medical history, physical examination, blood tests and urine sample collection.        -  Buccal mucosa sample collection. (Cells are collected from the inside of the cheek by          gentle scraping with a bristly brush.)        -  Bone marrow aspiration (only for volunteers 18 years of age and older).      Potential Stem Cell Donor      -Same as for healthy volunteers plus evaluations that may include electrocardiogram,     echocardiogram, imaging studies (X-rays, CT scans, MRI scans and others), heart evaluation,     and lung function tests.      Patient with Blood Disorder      -Same as for stem cell donors plus additional evaluations and treatments that may include     radiation oncology evaluation, catheter placement, blood transfusions, kidney and liver     biopsies. Short courses of drug treatment for induction of fetal hemoglobin in sickle cell     patients, and/or iron chelation in patients receiving chronic red cell transfusions may be     included as well.   "
217712|NCT00695370|"     Hypothesis: pegfilgrastim at 300 µg/kg in hematological steady state provides an efficient     stem cell mobilization in children with malignancies      Design: phase 2 study.      Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a     standard apheresis (less than 2 blood volume processed)   "
217713|NCT00695383|"     This randomized controlled trial was designed to investigate whether a daily training session     using a bedside cycle ergometer, started early in stable critically ill patients with an     expected prolonged ICU stay, could induce a beneficial effect on exercise performance,     quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard     physiotherapy program.   "
217889|NCT00703573|"     The purpose of this study is to evaluate the safety and efficacy of 2 doses of S-777469 in     patients with atopic dermatitis.   "
217694|NCT00695136|"     This study will test whether donepezil (Aricept(Registered Trademark)), a drug that is     approved by the Food and Drug Administration to treat Alzheimer's disease, can increase rapid     eye movement (REM) sleep in children with autism and autism spectrum disorder (ASD). Some     children with autism and ASD spend very little time in REM sleep. In some studies, decreased     REM sleep has been associated with learning and behavior problems. Donepezil can increase REM     sleep in some adults with different disorders. If it can increase REM sleep in children in     this study, it might be able to be used in future studies to see if it can help learning and     behavior problems in children with autism and ASD.      Children between 2 and 10 years of age with autism or an ASD whose percentage of REM sleep     time is well below the average for children of the same age may be eligible for this study.     Candidates are screened with a medical history, physical and neurological examinations, blood     tests, electroencephalogram (EEG) and a sleep study. The sleep study requires an overnight     stay at the NIH Clinical Center in which the child is monitored with electrodes for EEG and     heartbeat recording, a tube taped below the nose to measure airflow, a probe on a finger to     record oxygen levels and a small watch-like machine on the wrist to record movements.      Participating children may be required to have up to six overnight stays for sleep studies at     the Clinical Center. The children start by taking 1.25 mg of donepezil for 2 to 4 weeks. Then     they are admitted to the NIH Clinical Center for a sleep study, blood tests and EKG. Those     whose REM sleep increases to normal levels stay on 1.25 mg of donepezil for 8 more weeks,     after which they are admitted to the Clinical Center for a final physical examination, blood     draw and sleep study. That ends their participation in the study.      Children whose REM sleep does not increase to normal on 1.25 mg of donepezil are given a     higher dose (2.5 mg) for 2 to 4 weeks, and the above procedure is repeated. Those whose REM     sleep does not increase to normal on 2.5 mg of donepezil take 5 mg of the drug for 2 to 4     weeks, and the above procedure is repeated once more. Children whose REM sleep does not     increase to normal on 5 mg of donepezil stop the medication and end their participation in     the study.      At each study visit, study researchers talk to the parents and examine the children to     determine if donepezil is affecting the child's behavior and if the child is hav...   "
217695|NCT00695149|"     This clinical trial aims to treat a damaged spinal cord by injecting your own bone marrow     stromal cells (autologous bone marrow stromal cells) into cerebrospinal fluid through the     lumbar puncture, and assess the safety and efficacy of the procedure.   "
217738|NCT00695708|"     The purpose of this study is to reveal the effects of computer-aided cognitive-auditory     training on cerebral reorganization in schizophrenia.   "
217739|NCT00695734|"     This study aims to compare the performance of the tuberculin skin test, used for more than 50     years as a diagnostic tool for latent tuberculosis infection, with 2 blood tests which have     recently become commercially available (Interferon-gamma release assays) in a population of     immunosuppressed individuals with chronic renal failure undergoing long term hemodialysis   "
217740|NCT00695747|"     The purpose of this study is to compare the safety & effectiveness of the two types of     cataract and glaucoma surgeries. Results from this study may improve the surgical and post     surgical management and long term management of patients with these conditions in the future   "
217741|NCT00695773|"     This study is aimed at discovering the differences in outcomes, regarding quality of life     issues(continence, impotence) of patients who have had either laparoscopic or open surgical     technique for prostate cancer.   "
217696|NCT00695162|"     Study Objectives:        -  1. To examine the extent to which noise typical of nursing units reduces speech          intelligibility in acutely ill hospitalized patients        -  2. To examine the extent to which noise typical of nursing units impairs recall in          acutely ill hospitalized patients        -  3. To quantify severity of reduced performance associated with age, familiarity with the          healthcare setting, hearing and health status.      Plan:      One hundred and twenty inpatients from the four medical/surgical nursing units at the     Portland VA Medical Center, 60 with normal hearing and 60 with hearing impairment will be     recruited to participate in the study. Following assessment to ascertain eligibility and     obtaining informed consent, patients will be tested in a sound booth housed at the National     Center for Rehabilitative Auditory Research (NCRAR). Designed so that each patient serves as     his or her own control, we can accommodate considerable baseline variability between patients     without adversely affecting required sample size. Patients' performance in speech     intelligibility and recall tests will be measured using a constant level of speech, in     controlled environments of no noise (baseline), white noise, hospital noise and hospital     noise with speech, all delivered via headphones in pseudo-random order. Performance will be     measured in each type of noise at decibel levels equivalent to those currently experienced on     nursing units and at lower levels that prior studies have shown are more conducive to     effective communication      By selecting measures that are particularly relevant to the safe care of hospitalized     patients, and that have been studied extensively in healthy populations in highly controlled     conditions, we expect to find compelling and unambiguous evidence that hospitalized patients     correctly hear and recall very little of what is said to them during their hospitalizations.     The majority of hospitalized patients stay on acute care nursing units during most or all of     their hospitalizations, making this an appropriate population to study in the context of     their responses to the noises typical in these environments. Perhaps most importantly, this     study will heighten awareness of health-care personnel to the levels of impairment suffered     by their patients - both in their ability to correctly interpret speech and to recall it - in     the typical noisy environments of nursing units.   "
217697|NCT00695175|"     To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics,     health care management) of hypertensive patients seen in private cardiology consultation by     holding account of type of exercise of the cardiologist (private exclusive or mixed hospital     and private).   "
217698|NCT00695188|"     The primary objective is to determine whether erythrocyte polyglutamate levels are associated     with objective clinical response in patients with rheumatoid arthritis after oral     administration of low-dose methotrexate.The secondary aim of this study is to compare the     efficacy and safety of standard dose methotrexate versus a higher starting dose.   "
217699|NCT00695201|"     The purpose of this study is to see how well patients tolerate the side effects of treatment     with Floxuridine, Oxaliplatin and Irinotecan. We also want to know if these methods used     together are a useful way of treating cancer. We have studied these drugs and know the best     doses of each when they are used alone. We do not yet know how well the drugs work with each     other. This study will tell us the best doses of each drug when they are given over the same     period of time.   "
217700|NCT00695214|"     Prospective, interventional cohort study of drug-induced sleep endoscopy (DISE) to evaluate     the upper airway in a cohort of obstructive sleep apnea (OSA) surgical patients. This study     has investigated the reliability of this technique, demonstrating moderate-substantial     interrater and test-retest reliability. This research has also compared DISE findings to     those of the lateral cephalogram X-ray and examined DISE findings in individuals who have not     responded to previous sleep apnea surgery. These papers have been published and available     through PubMed. Additional research is ongoing, with examination of DISE findings, comparison     to other evaluation techniques, and the association between DISE findings and surgical     outcomes.   "
217714|NCT00695396|"     The purpose of this study is to demonstrate that Epoetin alfa treatment reduces red blood     cell transfusions in anemic patients with myelodysplastic syndromes (MDS). Myelodysplastic     syndromes are a group of disorders characterized by progressive bone marrow failure and an     increased risk of development of leukemia.   "
217830|NCT00702806|"     The primary objective of this trial was to investigate the appropriate dose of a single     injection of Org 36286 to initiate multifollicular growth for the first seven days in a     controlled ovarian hyperstimulation (COH) protocol for IVF and IVF/ICSI. After seven days,     participants were converted to treatment with Puregon® 150 IU and administration of the GnRH     antagonist Orgalutran® to finalize the stimulation cycle. Secondary objectives were the     safety (including the absence of antibody formation) and the direct effects of Org 36286 on     reproductive functions (steroidogenesis, oocyte maturation, embryo quality and implantation).   "
217701|NCT00695227|"     The purpose of this project is to develop an accurate method to identify patients that suffer     from acid reflux, but may not present with classic reflux symptoms (such as heart burn).     Additionally, it is the purpose of this project to utilize the Unsedated Small-caliber     Endoscopy (USE) to assess the prevalence of Barrett's esophagus in a population of patients     with laryngopharyngeal reflux (LPR) symptoms and to define normal patterns of LPR.     Laryngopharyngeal reflux (LPR) is when a small amount of stomach contents and acid are pushed     up through the esophagus and may affect the vocal cords and upper respiratory tract.      It is suspected that patients with LPR symptoms may have a prevalence of Barrett's esophagus     similar to that found in a population with typical reflux symptoms. We propose to     systematically test this hypothesis using the USE.      This project is designed to improve the methods of identifying patients with a form of acid     reflux that is often undetected, and thus untreated. If this project is successful then more     patients with Barrett's esophagus will be identified; furthermore, screening and treatment     for this pre-cancerous condition will be improved.   "
217702|NCT00695240|"     This prospective randomized controlled study will determine the efficacy of continuous local     anesthesia at decreasing pain scores compared to patient controlled analgesia for pelvic     organ prolapse procedures including posterior colporrhaphy and sacrospinous ligament     fixation.   "
217703|NCT00695253|"     The purpose of this study is to evaluate the safety and effectiveness of the Talent     Endoluminal Spring Graft System, an investigational device, to treat abdominal aortic     aneurysms (AAA). The treatment population will include patients with an abdominal aortic     aneurysm who meet the inclusion/exclusion criteria. All patients in the treatment population     will undergo post-procedure follow-up evaluations at one (1), six (6), and 12 months and     annually thereafter up to five (5) years post-procedure.   "
217704|NCT00695266|"     To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics,     health care management) of hypertensive patients seen in hospital out patient's department by     a cardiologist or a nephrologists.   "
217722|NCT00695500|"     This study will determine whether varenicline, a drug that acts on the brain's nicotine     receptors and is used to help smokers stop smoking, will have an impact on alcohol     self-administration.      People between 24 and 60 years of age who regularly consume alcoholic drinks (more than 15     drinks per week for women, and more than 20 drinks per week for men) may be eligible for this     study. The study requires five outpatient visits and one overnight hospital admission at the     NIH Clinical Center.      Participants undergo the following procedures:      Visit 1 (outpatient: 4-5 hours)        -  Standard assessments, including vital signs measurements, breathalyzer test, blood and          urine tests (including pregnancy test for females), questionnaires about mood, symptoms,          alcohol use and smoking, if applicable        -  Questionnaires about medical and psychological status        -  Health assessment and assessment of alcohol drinking behavior      Visit 2 (outpatient: 8 hours)        -  Standard assessments (see above)        -  Computer-Assisted Self-infusion of Ethanol (CASE) session: Subjects will receive a          priming intravenous infusion of alcohol. After 25 min, they will be allowed to give          themselves additional exposures of alcohol over a period of 2 hours by pressing a button          on a computer that controls the infusion pump.      Visit 3 (outpatient: 2 hours)      -Standard assessments      Visit 4 (outpatient: 8 hours)        -  Standard assessments        -  Brain functional magnetic resonance imaging scan (MRI). This test uses a magnetic field          and radio waves to produce images of the brain. The patient lies on a table that can          slide in and out of the scanner, wearing earplugs to muffle loud sounds that occur          during the scanning process. Initial pictures are taken of the brain's structure and          additional scans measure brain activity while the subject performs simple tasks.        -  Alcohol Infusion. Subjects receive an intravenous infusion of alcohol while in the MRI          scanner to measure the brain s response to alcohol.      Visit 5 (overnight)        -  Standard assessments        -  Repeat CASE session        -  Interview about the subject's experiences participating in the protocol, including any          symptoms and urges to drink      Visit 6 (outpatient)        -  Standard assessments (without blood tests)        -  Interview about participation in the study      Telephone follow-up      After 3 weeks, subjects are called to check on their symptoms and gather information on their     drinking and, if applicable, smoking.   "
217705|NCT00695279|"     This protocol (GENEFU) provides a mechanism for the 15-year followup period that the FDA     requires for all participants in gene transfer protocols and assures that adequate followup     can be maintained for a wide variety of participants on different individual gene therapy     protocols at St. Jude Children's Research Hospital.      GENEFU serves as an umbrella protocol for long-term follow-up (LTFU) for recipients of gene     therapy/gene marked (GT/GM) products at St. Jude Children's Research Hospital. The FDA has     recommended methods to assess the risk of delayed adverse events after GT/GM and has provided     specific requirements regarding the duration and design of LTFU observations. This protocol     is intended to provide LTFU in accordance with the FDA guidelines for those who received a     GT/GM product as part of a St. Jude-sponsored clinical trial or compassionate use treatment     plan. The protocol calls for a physical examination or general health evaluation and     collection of required blood samples annually for up to 15 years after the last receipt of a     GT/GM product.      Goals will be to obtain clinical histories in order to detect late clinical outcomes     suggestive of retroviral or lentiviral disease, including but not limited to cancer/second     malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders. Blood     samples will be archived and tested when clinically or scientifically indicated, as in the     event of development of a second malignancy. This prospective cohort study will utilize     descriptive statistics in the analysis of long-term late effects outcomes. It offers a     uniform approach to long-term safety monitoring in research participants who have received a     gene-transduced product as part of St. Jude-sponsored GT or GM protocols and compassionate     use treatment plans.   "
217706|NCT00695292|"     This proposed Phase II trial will investigate the combination of irinotecan and carboplatin     followed by sunitinib in the first-line treatment of patients with extensive-stage SCLC.   "
217707|NCT00695305|"     A study in patients with atherosclerosis to assess safety, effect and PK of rilapladib vs.     placebo over 12 weeks of dosing.   "
217708|NCT00695318|"     This study will compare the safety and efficacy of Medidur FA treatment in one eye to the     sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.   "
217709|NCT00695331|"     The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol     solution with intravenous oxytocin for labor augmentation in women without adequate uterine     contractions.   "
217710|NCT00695344|"     The purpose of this study is to evaluate if there is a significantly less incidence of major     clinical events due to graft vascular illness in recipients of a cardiac transplant on     treatment with an immunosuppressive combination, which includes Everolimus, compared to those     that continue the previously used immunosuppressive treatment.   "
217711|NCT00695357|"     Cross-sectional, one visit study. All the data will be collected through questionnaires.     Descriptives statistics will be applied to the data. 832 patients will participate to the     study and 104 physicians.   "
217730|NCT00695604|"     The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids     (ICS) vs. placebo in adults with chronic stable asthma.   "
217715|NCT00695409|"     This phase II clinical trial studies how well yttrium Y 90 ibritumomab tiuxetan, rituximab,     and high-dose chemotherapy followed by peripheral blood stem cell transplant in treating     patients with relapsed B-cell non-Hodgkin lymphoma. Monoclonal antibodies, such as yttrium Y     90 ibritumomab tiuxetan and rituximab, can block cancer growth in different ways. Some block     the ability of cancer cells to grow and spread. Others find cancer cells and help kill them     or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies can find tumor     cells and carry tumor-killing substances to them without harming normal cells. Giving     monoclonal antibody therapy, radioimmunotherapy (RIT), and high-dose combination chemotherapy     before a peripheral blood stem cell transplant may be an effective treatment for non-Hodgkin     lymphoma.   "
217716|NCT00695422|"     RATIONALE: Diagnostic procedures, such as anal swab collection, digital rectal examination,     and anal endoscopy and biopsy, may help find and diagnose anal and genital human     papillomavirus infection and squamous intraepithelial lesions and help doctors plan better     treatment.      PURPOSE: This clinical trial is studying ways to detect anal and genital human papillomavirus     infection and squamous intraepithelial lesions in HIV-positive patients enrolled in an AIDS     cancer clinical trial.   "
217717|NCT00695435|"     To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension,     Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic     Solution in normal volunteers.   "
217718|NCT00695448|"     This is an open-label, multi-center Phase I study conducted to define the recommended Phase 2     dose, toxicity profile, pharmacokinetics and biologically active dose range of GSK1059615.   "
217719|NCT00695461|"     Intestinal pathogenes are often involved in postoperative complications after colon surgery.     Probiotic bacteria, i e live bacteria which have beneficial effects on the host when     ingested, have been shown to reduce bacterial translocation in animal studies. However, in     humans studies results have varied. The purpose with this study was to find whether high     doses of Lactobacillus plantarum 299v affects the potentially pathogenic microflora of the     gut, bacterial translocation and cell proliferation in patients undergoing planned colon     surgery.   "
217720|NCT00695474|"     The purpose of the study is to describe vitamin D status among patients with type 2 diabetes     and to determine the association between serum 25-hydroxyvitamin D and glycemic control,     markers of inflammation and blood pressure   "
217733|NCT00695643|"     The purpose of the study is to determine whether mesalazine granules compared to placebo is     effective in prevention of recurrence of disease.   "
217723|NCT00695513|"     An important group of protein-bound uremic retention solutes originate from protein     fermentation in the colon. P-cresol is a putrefaction metabolite of tyrosine. Indole is     generated by fermentation of tryptophan. After absorption, the majority of p-cresol and     indole are further metabolised and conjugated to form p-cresylsulphate and indoxyl sulphate.     There is clear evidence, both in vitro and in vivo, that accumulation of these conjugated     fermentation metabolites in kidney disease is correlated with clinical (cardiovascular)     endpoints.      Bacterial protein fermentation can be influenced by altering the colonic microenvironment,     influencing the ratio of available carbohydrates to nitrogen, by shortening the colonic     transit time or a combination of these. From a theoretical point of view, functional foods,     i.e. pro-, pre- and synbiotics, fulfil these criteria.      Prebiotics have been defined as non-digestible food ingredients that beneficially affect the     host by selectively stimulating growth, and/or activity, of one or a restricted number of     bacteria in the colon. Dietary fibre may suppress the generation of bacterial protein     fermentation either by altering the colonic microenvironment or by shortening the colonic     transit time. Animal and clinical studies evaluating the effect of dietary fibre supplements     on the generation of bacterial fermentation metabolites have provided conflicting results.     These discrepancies may be related to specific properties of the dietary fibre investigated.     Dietary fibre may impair protein assimilation and the fermentability may vary to a     substantial extent.      Inulin and oligofructose have attracted much attention recently as nonabsorbable     carbohydrates with prebiotic properties. When inulin and oligofructose were added to a     controlled diet, significant increases were noted in colonic bifidobacterial populations, and     it has been proposed that these changes promote both colonic and systemic health through     modification of the intestinal microflora. Inulin and oligofructose are rapidly and     completely fermented by the colonic microflora with the production of acetate and other     short-chain fatty acids. In healthy individuals, supplementation with a mixture of inulin and     oligofructose was shown to lower p-cresol generation. Although data in healthy volunteers are     promising, no data are available in hemodialysis patients.   "
217724|NCT00695526|"     Cranberry, containing flavonoids, is effective on improvement of lipid profiles in     non-diabetic subjects. The Hypothesis of is to assess the effect of cranberry on lipid     profiles in type 2 diabetic patients using oral antidiabetic drugs.   "
217725|NCT00695539|"     This is a single-arm, phase IV, open-label, prospective, non interventional study to evaluate     the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in     approximately 900 Greek subjects with hypercholesterolemia under normal clinical practice.   "
217726|NCT00695552|"     This trial investigates the biological effect of exercise training on depression.     Participants will randomly be allocated to either a aerobic exercise group performing     exercise on stationary bikes or a group performing low-impact exercise such as stretching     exercises. Both groups will attend sessions three times per week for 3 months. Before and     after the intervention the investigators will measure the severity of depression using the     Hamilton depression rating scale (HAM-D17).   "
217727|NCT00695565|"     The purpose of this study is to determine whether ARC-4558 is effective in managing pain     associated with painful diabetic neuropathy.   "
217728|NCT00695578|"     The purpose of this research study is to evaluate the use of Biafine Cream on wounds created     by removal of actinic keratosis using cryotherapy in a clinical setting.   "
217729|NCT00695591|"     Lay Summary Patients with severe neuromuscular develop hypoventilation, which leads to     elevated carbon dioxide levels. Measuring only oxygen saturation levels with pulse oximetry     may be inadequate. End tidal carbon dioxide levels or arterial blood gases should be measured     periodically, depending on the clinical condition of the patient. A thorough review of     systems will help define any problems. Patients who are hypoventilating often have elevated     carbon dioxide levels at night and complain of a morning headache, restlessness or     nightmares, and poor quality sleep. This may cause daytime sleepiness. Insufficient     respiration with hypoxia may occur later, especially if the lung is damaged by chronic     aspiration.      We propose to evaluate the use of the Nonin LifeSense monitor in home evaluation of     respiration, oxygen level, heart rate, and carbon dioxide level and to develop interpretation     of the results that will lead to appropriate interventions for apnea, and insufficient     respiration.      Relevance to MDA Fewer than one per cent of the Muscular Dystrophy Association have     pulmonologists as co-directors.Late referral of progressive restrictive lung disease leads to     invasive support of respiratory failure. Early initiation of non invasive ventilation     techniques requires patience on the part of the caregiver and exploration of mask interfaces     and ventilation techniques. In addition, the development of new therapies, currently     manifested through enhanced diagnostic accuracy, will require new signal for initiation and     in the assessment of success or failure.      Aims Aim 1. To assess the utility of a small portable device (LifeSense Monitor Nonin Medical     Inc. Plymouth Minnesota) with extended recording capabilty to provide accurate diagnosis of     hypoventilation.      Aim 2. To provide an easily interpretable report defining sleep hypoxemia, hypercapnea, and     apnea.      Aim 3. To promote early evaluation and treatment of the respiratory problems in centers that     do not have pumonologists as these are essential to prognosis, whether of survival or of     quality of life, in neuromuscular diseases.   "
217731|NCT00695617|"     The optimal anticoagulation procedure during MARS treatment has not been defined. In various     multi-centre trials, such as MARS-RELIEF, anticoagulation procedures are left to the     discretion of the treating physician. On the one hand, given the increased risk of bleeding     associated with liver failure, high dosage of anticoagulation therapy should be avoided. On     the other hand, contact of blood or blood components with the extracorporeal circuit will     likely result in coagulation activation or even loss of coagulation factors.      Citrate anticoagulation has gained popularity, especially in hemodialysis patients. It     results in a highly effective anticoagulation, exclusively confined to the extracorporeal     circulation. Moreover, dependent on the type of dialyser membrane, citrate anticoagulation     resulted in reduced activation of other cellular components.      In contrast to hemodialysis patients, experience with citrate anticoagulation during     treatment with artificial liver devices is limited. The liver contributes substantially to     the metabolism of exogenous citrate. As a result, cirrhotic patients have decreased     endogenous citrate clearances. Importantly, blood purification devices contribute     substantially to overall citrate clearance, thereby preventing accumulation of citrate.     Several centres, including our own, have gained experience with citrate anticoagulation     during fractionated plasma separation and adsorption (FPSA), a related liver dialysis device,     in the treatment of liver failure patients.      Citrate anticoagulation during MARS treatment has not been studied so far.   "
217732|NCT00695630|"     An increase in the utilization of anesthesia and sedation medications by     non-anesthesiologists, including dentists, has grown dramatically. This has been prompted, in     part, by the need for pharmacological tools to address high levels of fear and anxiety about     dental care among the US population and the evidence of oral health disparities among those     who are fearful . Given the prevalence of dental fear in the general population and in the     various populations with the greatest burden of oral diseases, effective sedation techniques     are needed that are safe and effective in the hands of general dentists that make up the     front line in the efforts to reduce oral health disparities. This study is to determine     whether, when compared to a saline placebo, a single intraoral submucosal administration of     the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or     less the central nervous system (CNS) depression produced by a paradigm of stacked sublingual     dosing of triazolam (3 doses of 0.25 mg over 90 minutes).   "
217743|NCT00695799|"     The pollution of the operating room environment by anesthetic agents had been questioned,     studied and documented in the past. These investigations demonstrated the existence of     teratogenic effects in animals and the possibility of a decrease in mental performance,     reduced fertility, fetal loss, spontaneous abortion and addictive potential in humans with     chronic exposure to trace amounts of anesthetic agents. These findings led to the     establishment of exposure limits and industry standards by consumer protection agencies, such     as National Institute for Occupational Safety and Health (NIOSH). However, these standards     applied to inhalation anesthetic agents that were excreted from the lungs of patients during     expiration. These concerns about operating room pollution weaned away with the introduction     of intravenous anesthetic agents, such as propofol, because it was believed propofol was     excreted by systems other than the lungs. Recent research points to the contrary and     demonstrates the excretion of propofol vapor in the expired gases of patients. Furthermore,     animal experiments in our laboratory establish the existence of a biological mechanism     responsible for addiction in animals exposed to trace amounts of propofol. We propose to     study the exposure levels of anesthesia care providers in the operating room, during propofol     use, under standardized conditions. Our findings will help to establish preventive measures     for propofol addiction in anesthesia care providers.   "
217744|NCT00695812|"     Background: Autism is a complex developmental disorder involving difficulties in verbal and     nonverbal communication, social-emotional functioning, and markedly restricted interests and     activities. Strong evidence from research conducted with family members of children with     autism supports the role of genetic factors in its etiology. Thus, some family members are     characterized by the broad autism phenotype (BAP) which involves a clinical picture of milder     but qualitatively similar difficulties.      Working hypothesis and aims: Researchers recently initiated prospective longitudinal studies     investigating the early developmental profiles of young siblings of children with autism     (SIBS-A). Such longitudinal SIBS-A study is currently conducted at the Hebrew University and     includes the oldest siblings studied to date. Our main aim is to identify siblings who     manifest any autism or BAP characteristics.      Methods: Two groups, SIBS-A (n = 42) and siblings of children with typical development     (SIBS-TD, n = 62), were seen at ages 4, 14, 24, 36, 54 months and 7 years. We plan to     continue the investigation at age 10 years, a time when school related abilities and     social/emotional competences are more consolidated and to investigate the developmental     trajectories of children's abilities from age 4 months to 10 years using growth curve     analyses.      Expected results: We expect that compared to SIBS-TD, significantly more 10-year-old SIBS-A     will display difficulties related to ASD or BAP related difficulties. We also expect to     identify different patterns of stability and/or change in the development of children's     abilities from age 4 months to 10 years, between the two groups.      Importance: This study provides a useful approach for the examination of the main research     hypothesis regarding the development of SIBS-A. One of the main advantages of using the     growth curve analysis is the identification of early predictive markers for future     development.      Probable implications to Medicine: This research has significant implication for early     identification and the search into the causes of autism and the BAP, as well as for     implementation of early treatment and prevention programs. By highlighting expressions of ASD     and the BAP in siblings, we may identify early clinically predictive behavioral markers     associated with their onset and contribute to the investigation of underlying genetics     mechanisms.   "
217745|NCT00695825|"     Recent population studies have shown that the glycemic index (GI) of food products is     positively associated with the risk of developing type 2 diabetes and cardiovascular disease     (CVD). In the pathogenesis of type 2 diabetes and CVD, inflammatory processes play a pivotal     role. In a previous intervention study (11 weeks), however, we found no effects of lower-GI     vs. higher-GI diets on fasting inflammatory markers in subjects with increased risk of     developing the metabolic syndrome. People, however, spent most of their time in the     postprandial period. Therefore, there is a need to study the postprandial effects of low-GI     vs. high-GI diets. In addition, it needs to be emphasized the GI is derived from studies in     lean subjects, while especially overweight and obese people suffer from metabolic aberrations     related to the development of type 2 diabetes and CVD. AIM: To investigate in obese subjects     the postprandial effects of a low-GI vs. high-GI food product on metabolic risk markers. A     second research objective is to compare these effects with those in lean subjects.   "
217746|NCT00695838|"     The purpose of this observational study is to assess the impact of abdominal fat on severity     and frequency of GERD symptoms .   "
217840|NCT00702936|"     The purpose of this study is to compare the antinflammatory and endothelial progenitor cell     (EPC) mobilizing effect of Ramipril and Telmisartan in patients presenting with acute     coronary syndrome   "
225344|NCT00801944|"     Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose     increase. Primary efficacy assessment of OAB symptoms by patient diaries.   "
217747|NCT00695851|"     The purpose of this study is to find out whether giving a drug called PCK3145 can reduce the     level of a protein in the blood called MMP-9 as well as to find out how long the drug will     remain in your system over time. This drug has been tested previously in prostate cancer     patients abroad and has been shown to be safe with minimal side effects. However, we do not     know whether changes in MMP-9 levels correlate with tumor shrinkage or symptom improvement.     We would also like to evaluate the potential pain relief (analgesic) effect of PCK3145 at     15mg/m² i.v. weekly for 12 weeks on patients with both symptomatic and asymptomatic castrate     metastatic prostate cancer who are dependent on opioid analgesics. We would also like to     monitor pain through a brief pain questionaire, and determine the impact on markers of bone     turnover.   "
217748|NCT00695864|"     We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve     withdrawal symptoms experienced while the patient is being weaned off opioid medications.     This medication has shown anecdotal evidence of being affective for the treatment of     withdrawal symptoms and we hope to determine whether this is affective.   "
217749|NCT00695877|"     Successful control of the HIV epidemic will require a safe and effective vaccine to be     developed. A successful vaccine will need to stimulate a widespread immune response. The     purpose of this study is to determine the safety of and immune response to an adenovirus     serotype HIV vaccine in HIV uninfected adults.   "
217750|NCT00695890|"     Null hypothesis (HO): There will be no difference in pupillometry readings when using any of     the maintenance anesthetic techniques within subjects.      Alternate hypothesis (HA): Pupillometry readings will be affected by a change in the     anesthetic technique   "
217751|NCT00695903|"     The overall goals of this study are to compare the safety and efficacy of daptomycin     monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels     of 15 to 20 μg/mL for the treatment of methicillin-resistant S. aureus bacteremia (MRSA),     including right-sided infective endocarditis (RIE).   "
217752|NCT00695916|"     To see if performing breast MRI before a lumpectomy will help the surgeon successfully remove     the entire cancer with normal tissue margins in a single operation thereby reducing the need     for additional surgical procedures. The study will also measure how well MRI can find     unsuspected cancers in the same breast as the known cancer; how well MRI will find     unsuspected cancers in the opposite breast; how often MRI will generate false positive MRI     findings; whether routinely incorporating breast MRI delays care or adds unnecessary cost;     and, whether breast MRI is able to reduce the frequency of cancer recurrence in the treated     breast or elsewhere in the body.   "
217753|NCT00695929|"     Many pediatric patients undergoing cardiac surgery under cardiopulmonary bypass for repair of     complex congenital malformations, require inotropic support for low cardiac output syndrome.     Milrinone through its positive inotropic and vasodilatory effects is widely used for this     purpose. The aim of the study is to compare Milrinone with Levosimendan, a novel inotope with     calcium-sensitizing properties. We hypothesized that using Levosimendan would result in     reduced serum lactate through a higher cardiac index.   "
217754|NCT00695942|"     Venous thromboembolic (VTE) disease is the first cause of maternal mortality in the world.     Some other pregnancy pathologies called Placental Vascular Pathologies (PVP) are linked to     VTE by biological thrombophilia and are the principal cause of perinatal mortality. the     identification of predictive factors of risk of occurrence or recurrence of two pathologies     could enable us to propose an appropriate monitoring of patients at risk.   "
217755|NCT00695955|"     This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan     medoxomil in individuals with essential hypertension.   "
217756|NCT00695968|"     To determine the sensitivity, specificity, and accuracy of preoperative ultrasound,     elastography, mammography and breast MRI in women with dense breast tissue diagnosed with     breast cancer; to test whether elastography or MRI can improve upon routine mammogram and     conventional ultrasound in women with dense breast tissue.   "
217757|NCT00695981|"     This study aims at determining the effectiveness and cost-effectiveness of surgical     management of full-thickness rotator cuff tears compared to conservative treatment. The     research setting is prospective, randomised, and controlled.      The aim of the study is to search out evidence based data of indications for rotator cuff     repair. The investigators also aim at offering patients the most efficient and effective     treatment and reduce the number of operations that do not have sufficient effectiveness. The     data obtained will facilitate developing guidelines for referrals to a specialist when     rotator cuff tear is suspected.      The investigators hypothesize that there are subgroups of patients suffering from rotator     cuff tears that benefit from surgery whereas other subgroups are best treated conservatively.   "
217758|NCT00695994|"     The aims of this study are:        1. to compare the toxicity profile and efficacy of gemcitabine/carboplatin or docetaxel in          East Asian and Caucasian patients.        2. to determine the genotype distribution of genes involved in docetaxel and gemcitabine          pathways in East Asian and Caucasian patients.        3. to evaluate the association between genotypes and             1. treatment toxicity             2. treatment efficacy             3. pharmacokinetics.   "
217759|NCT00696007|"     The purpose of this study is to test the effectiveness, safety and side effects of two     chemotherapy drugs (gemcitabine and cisplatin) when combined with surgery after chemotherapy     for patients with upper urinary tract cancer. The hypothesis is that undergoing chemotherapy     prior to surgery will have a beneficial effect on prognosis and may improve overall survival     as in patients with bladder cancer, and will allow better tolerance of chemotherapy than if     it were given after surgery.   "
217760|NCT00696020|"     The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL     administered with 5 micrograms tiotropium bromide solution for inhalation, delivered by the     Respimat inhaler, once daily for four weeks in patients with chronic obstructive pulmonary     disease (COPD).   "
217772|NCT00696176|"     The primary goal of this study is to evaluate the safety of a transcription factor decoy     targeting Signal Transducer and Activator of Transcription 3(STAT3) in patients with head and     neck cancer. The rationale for targeting STAT3 using this approach is to decrease     STAT3-mediated gene regulation. The study has the following scientific objectives:        1. To assess the safety of a single dose of intratumoral STAT3 decoy.        2. To estimate the effect of STAT3 decoy therapy on STAT3 activation levels, STAT3-mediated          gene expression, and apoptosis in treated tumors.   "
217761|NCT00696033|"     Aims :        -  exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy          volunteers, on the neural correlates of encoding and retrieval of information during a          word-stem completion task (implicit memory), using fMRI        -  comparing lorazepam effects to diazepam (0.3 mg/kg)effects        -  exploring benzodiazepines effects, after a single oral intake, on the neural correlates          of successful encoding of information within explicit memory using fMRI      Hypothesis :        -  both diazepam and lorazepam will impair explicit memory performance, but lorazepam only          will impair perceptual priming        -  lorazepam and diazepam will modify the normal correlates of information encoding within          explicit memory        -  lorazepam only will alter the neural correlates of perceptual priming   "
217762|NCT00696046|"     Compared to other stemcell sources cord blood (CB) is easier and safer to procure, has no     donor attrition, a limitless supply, reduced viral transmission, less acute & chronic GVHD,     is rich in hematopoietic progenitor cells, and immaturity of T-cell-mediated immunity. CB has     delayed neutrophil and platelet engraftment, a prolonged immune reconstitution, uncertain     graft-vs-tumor activity, and cell doses from single CB units (U) are a limiting factor for     larger recipients Using the intravenous route (IV), a close match between the patient (pts)     and the donor or CBU can improve a pts outcome after transplant. Even though a closely     matched CBU is preferred, the studies suggest the match may not have to be as close as is     needed for marrow or peripheral blood transplants If one has an uncommon tissue type, the     doctor may not find a closely matched adult donor and a CBU may be an option, are stored and     ready to use. GVHD is a complication after an allogeneic transplant. Studies founded that     after a CBtransplant, fewer pts get GVHD than after marrow or peripheral blood transplants.     Pts in the studies who did get GVHD after CBtransplant tended to get less severe cases We     hypothesized that direct intrabone transplant of CBcells could improve haematologic recovery     due to a better stem cell homing, based on the following observations: stem cells recirculate     in animals irradiated with limb shielding; a limited fraction (10-15%) of cells injected iv     to the haematopoietic sites, possibly because the large majority is lost in other organs; in     a mousemodel, HSC directly injected ib repopulated the marrow of lethally irradiated mice     10times more efficiently than HSC cells injected iv; delayed engraftment after CB transplant     is possibly not caused by insufficient stem cell numbers; indeed, children grafted with CB     cells have superior stem cell reservoir 1year posttransplant when compared to marrow     transplant recipients Based on these data, we set-up a phase I-II study to evaluate whether     ib injection could be safely performed and whether this procedure could ensure engraftment     and shorten the time of complete hematopoietic recovery in adults with high risk     haematopoietic malignancies compared to the published data. Neutrophil recovery >80% at day60     and Platelets recovery >80% at days100 were defined as success. 1° endpoint was the     probability of neutrophils and platelets recovery after ib CB transplant, 2° included     incidence of acute GVHD, relapse, overall survival   "
217763|NCT00696059|"     Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis     (RA) patients have found that erosive damage may heal in some RA patients treated with     anti-TNF. Repeated examinations of adalimumab (Humira) treated RA patients, using computed     tomography (CT), magnetic resonance imaging (MRI), ultrasonography (US) and radiography will     allow detailed assessment of the extent of bone repair/healing during adalimumab (Humira)     therapy.   "
217764|NCT00696072|"     The purpose of this study is to find out what effect the combination of letrozole (brand     name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to     letrozole alone   "
217765|NCT00696085|"     The goal of this study was to determine whether a series of blood markers of alcohol use     obtained from alcohol using pregnant women could help them to change their behavior.   "
217766|NCT00696098|"     Short chain fatty acids (mainly butyrate, acetate, and propionate) are produced in the large     intestine by bacterial fermentation of undigested carbohydrates, such as dietary fibres.     Butyrate is an important energy source of the intestinal epithelium and has a pivotal role in     the regulation of epithelial cell proliferation and differentiation, immune function and     mucosal protection.      Non-digestible carbohydrates (prebiotics) increase the concentrations of colonic butyrate,     which has been proposed to be responsible for its beneficial effects. Furthermore, butyrate     enemas have been proven to be effective in the treatment of active ulcerative colitis.      In the present study, the direct effects of butyrate on inflammation and parameters of     colonic defence and mucosal integrity of the distal colon will be studied in 40 patients with     diarrhoea predominant IBS (D-IBS) and 40 patients with ulcerative colitis in remission     (UCrem) using rectal enemas. These patients groups were chosen because they have a low-grade     inflammation in the large intestine, and can therefore be used as a model to study the     mechanistic effects of butyrate. The design used to study the effects of butyrate in both     patient groups will be a double blind randomized placebo-controlled parallel design.   "
217767|NCT00696111|"     The purpose of this study is to look at the metabolic (use of energy) and hormonal features     of sleep problems in women with polycystic ovary syndrome (PCOS).   "
217768|NCT00696124|"     The purpose of this study is to determine the safety, tolerability and preliminary efficacy     of intramuscular injections of VM202 for subjects with critical limb ischemia.      Subjects selected for this study will have critical limb ischemia that has not responded to     standard therapy with symptoms including pain at rest and/or ischemic ulcers.   "
217769|NCT00696137|"     This study is designed to provide continued access to BEMA Fentanyl for those subjects who     previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the     treatment of their breakthrough cancer pain.   "
217770|NCT00696150|"     Studies have suggested a link with effective pain relief and reduced illness and death in     very unwell patients. This study will determine the most effective method of injecting local     anaesthetic around the nerves which supply the hip joint. Local anaesthetic will be injected     around the hips nerve supply using either ultrasound, loss of resistance or electrical nerve     stimulator to guide the positioning of the needle on patients due for elective total hip     replacement. The patient will then be observed for 30 minutes and the patient ability to move     or feel the upper leg will recorded. A standard anaesthetic and a hip replacement operation     will then be performed. Standard pain relief protocols will be used the operation and after     the operation. After the operation we will record the amount of morphine used and how happy     the patients have been with their treatment at 6 hours after the operation and at 24 hours     after the operation. The first day the patient is able to walk on their new hip replacement     will also be recorded.   "
217771|NCT00696163|"     This study is conducted in Asia. The aim of this observational study is to evaluate the     quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart     30) for the treatment of diabetes mellitus under normal clinical practice conditions in     India.   "
217842|NCT00702962|"     The Phase I portion of the study is to assess the maximum tolerated dose of vorinostat when     combined with carboplatin plus etoposide. The Phase II portion is to determine     progression-free survival among patients with extensive disease small cell lung cancer     receiving carboplatin plus etoposide with vorinostat.   "
217773|NCT00696189|"     The concept of ocular perfusion pressure (OPP), is defined as the difference between the mean     arterial pressure (MAP) and the intraocular pressure (IOP.)It has been hypothesized that     unopposed decreases in MAP, increases in IOP or a combination of the two may result in hypo     perfusion of the eye and can cause an ocular infarction at the level of the retina or optic     nerve, leading to varying degrees of visual loss which is frequently bilateral and     irreversible.      Both the prone position and downward head tilting (Trendelenburg position) have been     associated with increases in IOP compared to the supine horizontal position (2,4,5,6), but it     is not known whether the Trendelenburg position during surgery and anesthesia is associated     with POVL.   "
217774|NCT00696202|"     In this trial the efficacy and safety of Mirena was investigated during the first year of use   "
217775|NCT00696215|"     The objective of the study is to assess the effects of rasagiline on cognitive functions in     patient with Parkinson's disease. Patients on any dopaminergic medications will be assigned     to receive rasagiline 1 mg or placebo over 3 months. Cognitive functions will be assessed by     selected neuropsychological tests representing each cognitive domain.   "
217776|NCT00696228|"     To test the effects of a modified Atkins high fat diet on endothelial function, insulin     resistance and energy balance.   "
217777|NCT00696241|"     The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil,     once daily (QD), compared to placebo and olmesartan in participants with essential     hypertension.   "
217778|NCT00696254|"     The aim of this study is to investigate the effect of general anaesthetics on nerve     excitability. We use the method of threshold tracking to measure selected parameters of nerve     excitability.   "
217779|NCT00696280|"     Delayed emesis following administration of carboplatin-based chemotherapy despite prophylaxis     with standard antiemetic prophylaxis (5-HT3 and corticosteroid) remains a clinically     significant and distressing problem for patients with cancer. The incidence of delayed emesis     appears to be higher in women compared to men.   "
217802|NCT00702156|"     The principal research objectives are to demonstrate cardioselective beta-blockade using     bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality     of life in patients with heart failure and coexistent moderate or severe chronic obstructive     pulmonary disease with or without significant reversibility. Patients will be followed up for     4 months during which bisoprolol will be up-titrated to the maximum clinically tolerated     dose. Health status will be assessed using a generic and two disease specific questionnaires,     and pulmonary function by spirometry, body box plethysmography, and cardiopulmonary exercise     testing.   "
221750|NCT00753415|"     This is a two-part study to test the safety, tolerability, and immune response for V934/V935     vaccine using a new prime-boost regimen in participants with selected solid tumors.   "
217780|NCT00696293|"     The following primary hypotheses will be tested:        1. During Step 1: Major Depressive Disorder (MDD) or Chronic Low Back Pain (CLBP) in < 40%          of the initial 60 subjects treated with duloxetine (DUL) + Clinical Management(CM)          during the first 8 weeks will respond (response is defined as a Montgomery Asberg          Depression Rating Scale (MADRS) score </=9 and at least a 30% improvement in back pain          as measured with the 20-point numeric rating scale.        2. During Step 2: More DUL+Problem Solving Therapy for Depression and Pain (PST-DP) than          DUL+CM treated subjects will achieve response during the second 8 weeks, defined as a          MADRS score </=9 and at least a 30% improvement in back pain as measured with the          2-point numeric rating scale.        3. Improvement in depression scores will be correlated with improvement in CLBP scores.      The exploratory hypotheses to be tested are that:      During Step 2: Compared to subjects treated with DUL+CM, subjects treated with DUL+PST-DP     will have improved outcomes in: 1) disability, 2) sleep, 2) functioning/quality of life, 3)     caregiver burden/depression, and 5) analgesic use.   "
217781|NCT00696306|"     The purpose of the study is to use diffusion tensor imaging (DTI) derived axial diffusivity     and susceptibility weighted imaging (SWI) to evaluate the severity of acute ischemic stroke     and to predict its functional outcome.   "
217782|NCT00696319|"     The study that is registered in ClinicalTrials is a part study of an overall study with the     title 'Dynamic stability of the ACL-injured knee'. The aim of the overall study is to     prospectively follow a cohort of newly injured patients with total rupture of the anterior     cruciate ligament in the knee, in order to document results from different rehabilitation     regimes after the injury.      The title of the part study is 'Neuromuscular changes in ACL-deficient individuals before and     after an intensive perturbation training program. A case-control study.' The aims of the part     study are:        1. To describe muscle activation patterns, joint angles and forces during gait and          one-legged hop in newly injured ACL-deficient individuals before and after execution of          an intensive training program consisting of either perturbation training or conventional          balance- and stability training        2. To describe eventual changes between the two groups that may indicate superiority of          either one of the methods      The study will include 25 subjects in each group. The intervention consists of two different     rehabilitation protocols for neuromuscular training. Subjects will be tested in a     biomechanical laboratory before and after intervention, with use of 3D camera systems, force     plates and electromyographic measurements (EMG). Main outcomes are eventual differences in     muscle activation patterns, joint angles and forces during selected phases of walking and     one-legged hopping. Secondary outcomes of interest are self-assessment of knee function,     isokinetic strength and functional one-legged hop tests.      Status: Inclusion to the main study started in January 2007. Data collection for the     case-control part study will take place in 2008-2009. The part study study should be finished     in 2010, where results will be included in a PhD dissertation. The PhD student responsible,     Ingrid Eitzen, is enrolled in the Doctoral program at the Faculty of Medicine, University of     Oslo. She is employed at Orthopaedic Centre, Ullevaal University Hospital and part of The     Norwegian Research Center for Active Rehabilitation (NAR). The project is included in the NAR     research program. In addition, the overall study is organized as a formalized collaboration     with the University of Delaware, US, where they also will follow a cohort of 150 subjects.   "
217783|NCT00696332|"     The purpose of this study is to assess the efficacy, tolerability and safety of oral     administration of talampanel compared to a placebo in subjects with ALS.   "
217784|NCT00696345|"     Epigenomics is developing a colon cancer screening assay based on differential methylation of     specific CpG sites for the detection of early stage disease. A genome-wide methylation     analysis and oligonucleotide array study using DNA from various stages of colon cancer and     normal tissue have been completed to obtain candidate CpG markers. Based on results obtained     in the above studies, Epigenomics has moved to the final stages of feasibility with a     specific, highly sensitive real-time marker assay that is able to detect colon cancer DNA in     blood plasma.   "
217785|NCT00696358|"     308 nm excimer lamp and 308 nm excimer laser have both provide interesting results in     treating vitiligo. They have the same wavelength but the type of emission of the photons is     different. To date there is no direct comparative data concerning these two devices in this     indication.      The aim of the study is to make an intra-individual prospective comparison between these two     phototherapies.   "
217786|NCT00696371|"     This study will use positron emission tomography (PET) to measure a receptor in the brain     that is involved in inflammation. It will test two radioactive chemicals used in the     procedure to see if the newer chemical, [(11)C]B, is as good or better than the older one,     [(11)C]A, for measuring brain inflammation.      Healthy volunteers 18 years of age and older may be eligible for this study. Participants     undergo an evaluation, [(11)C]A PET scan, [(11)C]B PET scan and magnetic resonance imaging     (MRI), as follows:      Evaluation      Medical history and physical examination, blood and urine tests      PET scans        -  [(11)C]A scan. A catheter (plastic tube) is placed in an arm vein for injection of the          [(11)C]A isotope. Some patients also have a catheter placed in an artery in the wrist to          collect arterial blood samples during the scan. Subjects then lie on the scanner bed and          a special mask is fitted to the head to help keep the subject s head still during the          procedure. Following an 8-minute scan to calibrate the scanner, the [(11)C]A is injected          into the catheter in the vein and pictures are taken that show where chemicals related          to inflammation are present. The procedure takes about 2.5 hours.        -  [(11)C]B scan. The procedure is the same as above for [(11)C]A, except the isotope used          is [(11)C]B.      MRI scan.      This test uses a strong magnetic field and radio waves to obtain images of body organs and     tissues. The subject lies on a table that can slide in and out of the scanner (a metal     cylinder), wearing earplugs to muffle loud noises that occur during the scan.   "
217787|NCT00696384|"     The purpose of this study is to determine the long term safety and tolerability of azilsartan     medoxomil, once daily (QD), in participants with Essential Hypertension.   "
217788|NCT00696397|"     The purpose of this research is to study the sleep patterns of people with moderate to severe     atopic dermatitis and how itching affects those patterns. This study will also measure your     body's activity during sleep using non-invasive tests described below.   "
217803|NCT00702169|"     Background: Patients that suffer from respiratory failure and need mechanical ventilation are     at risk of further deterioration due to complications induced by progression of lung disease     or the mechanical ventilation. The complications usually develop in a progressive manner, but     are currently detected relatively late, when there is already severe and life threatening     deterioration in patient oxygenation and sometimes irreversible damages.      Objective:To measure chest wall dynamics, derived from sensors placed on the chest and     abdomen.      Methods: The system comprises of patches attached to the chest wall and upper abdomen that     include mechanical sensors that measure the mechanics of lung inflation and deflation.   "
217804|NCT00702182|"     The purpose of this study is to define the schedule and dose of oral vinorelbine (Navelbine)     to be used with erlotinib in non-small cell lung cancer.   "
217789|NCT00696410|"     Heart failure affects over 5.3 million Americans and, while other cardiovascular diseases     have enjoyed a reduction in mortality rates over the last decade, the mortality from heart     failure continues to rise[1]. Thus, identifying novel therapies that can reduce heart failure     development and/or progression are warranted. Unifying to most cardiomyopathic processes is     an impaired handling of reactive oxygen species (ROS)[2-4]. Reactive oxygen species are     generated as byproducts of inflammation and oxidative stress that occur in the setting of     normal myocardial aerobic metabolism. Metallothionein, glutathione reductase, and superoxide     dismutase are major antioxidants in the myocardium that help combat oxidative stress and     prevent myocardial damage. In certain clinical settings, including cardiac ischemia,     diabetes, and heavy metal excess (copper, iron), myocardial oxidative stress levels are     greatly increased. When pro-oxidant levels exceed myocardial antioxidant capabilities,     ROS-induced membrane, protein, and DNA inactivation can lead to the development of cardiac     dysfunction.      One means of preventing the development or progression of cardiomyopathy is to reduce     oxidative stress through up-regulation of intramyocardial antioxidants. Murine studies of     cardiomyopathy have shown that oral administration of zinc acetate may succeed as an indirect     myocardial anti-oxidant because zinc sufficiently up-regulates the intramyocardial production     of superoxide dismutase (a zinc-dependant anti-oxidant enzyme) and metallothionein (a super     antioxidant) [5-8]. Zinc also directly reduces prooxidant Cu levels by reducing     gastrointestinal zinc absorption. However, to date, no studies have examined the impact of     zinc acetate supplementation in subjects with cardiomyopathy and systolic failure on     antioxidant capacity and remodeling.      The hypothesis of this pilot study is that administration of oral zinc acetate to humans with     cardiomyopathy will lead to an up-regulation of myocardial anti-oxidant capabilities,leading     to a favorable reduction in oxidative stress. This study will provide preliminary data to     support a randomized, placebo-controlled trial of zinc therapy in heart failure as a means of     improving or preventing the progression of systolic dysfunction in subjects with     mild-moderate heart failure.   "
217790|NCT00696423|"     This protocol posting deals with objectives & outcome measures of the booster phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals'     DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to     24 months of age, in terms of safety and immunogenicity.   "
217791|NCT00696436|"     The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil,     once daily (QD), compared to placebo, valsartan and olmesartan in participants with essential     hypertension.   "
217792|NCT00696449|"     The primary objective of this study is to investigate potential differences between four     treatment intervention groups in the adherence to treatment with Differin® Gel, 0.1%.     Differin is approved by the Food and Drug Administration (FDA) to treat acne.   "
217793|NCT00696462|"     The purpose of this study will be to assess whether forced air warming decreases the rate of     surgical site infections following cesarean section.   "
217794|NCT00696475|"     Hypertriglyceridemia affects 30% of the population in the US. Very high level of     triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that     hypertriglyceridemia is an independent risk factor for cardiovascular disease.      Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for     the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant     hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential     therapeutic agent for hypertriglyceridemia.      Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has     been formulated as a controlled-release tablet suitable for once per day dosing. This current     study is designed to assess the effect of diazoxide choline on triglycerides in subjects with     baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose     and insulin, body weight as well as the safety and tolerability of diazoxide choline will be     assessed.   "
217795|NCT00696488|"     The purpose of this research study is to measure adherence to the study drug (Carac) for the     treatment of actinic keratoses.   "
217796|NCT00696501|"     The purpose of this study is to collect data while monitoring muscles and nerves during spine     surgery. The data being collected and analyzed will be used to learn more about how the     body's nerves and muscles are distributed and develop a map of human muscle innervation     patterns.   "
217797|NCT00696514|"     It is hypothesized that vitamin B12 and folic acid supplementation reduces the number of     incident fractures. The proposed study, a randomized placebo-controlled intervention trial,     compares daily supplementation with folic acid (400 mcg) and vitamin B12 (500 mcg) to a     placebo for a period of two years or longer in 3000 men and women aged 70 years and older,     with initial basal plasma total homocysteine (tHcy) levels >= 15 micromol/L. Fracture     incidence and time to fracture will be assessed and used as the efficacy measure.      Metabolic studies in a sub sample of the population will be included aiming to contribute to     an understanding of the biological mechanisms underlying the associations found between     markers of B-vitamin status and bone quality.   "
217798|NCT00702104|"     RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to     treat.      PURPOSE: This research study is looking at whether patients who are being screened for     prostate cancer have been previously screened.   "
217799|NCT00702117|"     The study evaluates 3 different populations:      It is an open, randomized, parallel-group study comparing the effectiveness of intravenous     (iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :        1. recent-onset atrial fibrillation versus iv flecainide        2. sustained monomorphous ventricular tachycardia versus iv procainamide      The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline     versus iv flecainide in the diagnosis of Brugada syndrome   "
217800|NCT00702130|"     Statins present anti-inflammatory and immunomodulatory effects. They may modify the     regulation of cytokines, (released from the cellular damage) and may reduce the production of     C-reactive protein levels. It has been hypothesized that these pleiotropic characteristic of     statins might be useful in the management of various diseases, including pneumonia. Indeed, a     recent study showed that statin treatment is associated with reduced risk of pneumonia in     diabetic patients. However, the relationship between statins and reduced risk of pneumonia is     not consistent . In addition there is no prospective study to investigate the role of statins     in severe forms of pneumonia such as the VAP.      On this base the investigators aim to study prospectively the effect of statins on the     outcome of patients with VAP in the ICU settings. The investigators therefore contacted a     double open label randomized trial to investigate whether the use of pravastatin reduces the     incidence of Ventilator Associated Pneumonia in the ICU and whether it is related with     favorable outcome of patients with Ventilator Associated Pneumonia.   "
217801|NCT00702143|"     Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy     control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment     (MCI).   "
217805|NCT00702195|"     The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa     clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment     programs was safe for pregnant subjects and their offspring. Data from subjects who     participated in Trials 38805 and 38807 and became pregnant were evaluated.   "
217806|NCT00702208|"     The aim of this study is to see whether a new self-sampling device, the Delphi Screener     (Delphi Devices, Scherpenzeel, Netherlands), can be used for cervical cancer screening. The     results using the new device will be compared to results using the current gold standard. The     gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often     referred to as a 'Pap smear'). Additionally, women will be asked about the acceptability of     using the device and how easy it is to understand the user instructions.      The Delphi Screener is a sterile, plastic, syringe-like device containing buffered saline     which allows a woman to collect her own vaginal lavage (to 'self-squirt'). The hypothesis is     that the device may work well for cervical cytology and will be acceptable to the women in     the study.   "
217807|NCT00702221|"     Angiotensin Therapeutic Vaccine (ATV), which contains the novel adjuvant, CoVaccine HT™ , is     being developed for the treatment of high blood pressure (hypertension), a major risk factor     for serious diseases such as heart attacks and strokes. Many patients with high blood     pressure fail to take their medicines as prescribed because they generally feel well, which     often results in poor control of the condition. As a result, it is estimated that about 70%     patients with hypertension do not have their blood pressure adequately controlled despite     advances in the treatment of high blood pressure.      The main aim of this study is to find out if an injection of ATV given in the arm once every     3 weeks on 3 occasions results in lowering overall blood pressure measurements throughout the     day. The other aims are to find out if ATV is safe and to see how well it is tolerated   "
217808|NCT00702234|"     The objective of this trial is to evaluate whether corifollitropin alfa (Org 36286) treatment     for the induction of multifollicular growth in women undergoing controlled ovarian     stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection     (ICSI) is safe for pregnant participants and their offspring. In addition, a primary efficacy     variable, live birth rate, was evaluated.   "
217809|NCT00702247|"     To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant     approach in newly diagnose myeloma patients younger than 65 years   "
217810|NCT00702260|"     The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under     fed conditions.   "
217811|NCT00702273|"     To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are     cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), in order to estimate the     cumulative pregnancy rate for each treatment group.   "
217812|NCT00702286|"     Catheter associated urinary tract infection is one of the most common types of catheter     acquired infections and adds greatly to patient morbidity, mortality and medical cost.     Urinary catheters may readily acquire biofilms when inserted. The longer the catheter remains     in place, the greater the tendency of these organisms to develop biofilms and result in     urinary tract infections, which are difficult to treathe UroShield System is intended to     prevent bacterial biofilm formation by means of the Active NanoShield technology it has     developed. A number of scientific concepts and principles shown in prior studies have shown     some promising results in the treatment of biofilm based sequele using ultrasound energy. The     NanoShield technological basis of the UroShield System has taken these concepts to a level     where acoustical waves in the ultrasound range can be created by low cost disposable     actuators which actually create a physical coating on all of the surfaces of the catheter     thereby interfering with the attachment of bacteria which is the initial step in biofilm     formation.   "
217813|NCT00702299|"     RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving pemetrexed together with cisplatin and paclitaxel and giving them     in different ways may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal     pemetrexed when given together with intraperitoneal cisplatin and paclitaxel in treating     patients with stage III ovarian epithelial cancer, primary peritoneal cancer, or fallopian     tube cancer.   "
217814|NCT00702312|"     The aim of this study is to assess the benefits of using low-salt and healthy eating     educational programme, designed specifically for Bangladeshi kidney patients, compared to the     usual diet advice given by the clinic dietitians.   "
217815|NCT00702325|"     To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to     that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African     American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.   "
217816|NCT00702338|"     The objective of follow-up study P05713 is to evaluate whether corifollitropin alfa (Org     36286) treatment for the induction of monofollicular growth in women who underwent ovulation     induction (OI) in base study P05693 (NCT00697255) is safe for pregnant participants and their     offspring.   "
217817|NCT00702351|"     To evaluate the induction of multiple follicular growth after single dose administration of     100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist.   "
217818|NCT00702364|"     Atomoxetine is the only medication that is currently approved by the FDA for the treatment of     attention deficit hyperactivity disorder in adults. It has gained recent interest as an     alternative medication for treating attentional problems related to traumatic brain injury     (TBI), but it's effectiveness in this population has not been studied. There are a number of     advantages of Atomoxetine over traditional neuro-stimulant medications currently used for     attentional disorders after traumatic brain injury. This study will use a randomized     double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine     to improve attention, behavioral function, and depression in adults with TBI   "
217819|NCT00702377|"     To evaluate the safety and efficacy of two artificial tears in dry eye patients.   "
217870|NCT00703326|"     The objective of this study is to compare the progression-free survival (PFS) of the drug     combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated     participants with human epidermal growth factor receptor 2 (HER2)-negative, unresectable,     locally-recurrent or metastatic breast cancer.   "
217820|NCT00702403|"     This phase I/II trial is studying the side effects and best way to give nilotinib when given     alone or sequentially after imatinib mesylate after donor stem cell transplant in treating     patients with acute lymphoblastic leukemia or chronic myelogenous leukemia. Nilotinib and     imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth.   "
217821|NCT00702416|"     This study has been designed to assess the possible advantages of using ultrasound imaging to     block the brachial plexus (i.e., nerves of the upper limb) in patients undergoing shoulder     surgery.      The ultrasound technique will be compared with the current gold standard, electrical nerve     stimulation.      The aim of this study is to define which technique is better in terms of time to onset of     anesthesia.   "
217822|NCT00702429|"     Our design is to test in hospital practice a selection of immune parameters that could assess     the pathophysiology and progression of periodontal lesions.   "
217823|NCT00702442|"     Protocol title: Role of low dose droperidol in postoperative vomiting      Purpose: Evaluate the efficacy of droperidol to postoperative nausea and vomiting when     administrated at the introduction to anesthesia, prior to surgery      Design: Prospective, randomized, placebo-controlled study      Patient Population: Male or female subjects 18 years of age or older who are scheduled for     laparoscopic cholecystectomy      No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to enroll      Duration of Treatment: Prior operation      Duration of Follow-up: Follow-up will be performed for 24 hours postoperatively      Endpoints: To evaluate the effectiveness of low dose droperidol when administered Prior     surgery   "
217824|NCT00702728|"     This study is being proposed with the objective to assess the potential benefits of induced     diuresis by furosemide with matched hydration therapy compared to standard hydration in the     prevention of contrast-induced nephropathy (CIN). It is expected that matched hydration will     prove to be as effective as hydration alone, will avoid an overnight stay prior to the     procedure, and thus will prove to be a less costly and more clinically manageable solution to     the prevention of CIN.   "
217825|NCT00702741|"     The objective of the present study is to establish the long-term safety of an intra-articular     injection of human mesenchymal stem cells (hMSCs) (Chondrogen).   "
217826|NCT00702754|"     Five hundred patients with a confirmed clinical diagnosis of Cervical Dystonia (CD)are     planned for enrollment into this open label study. These patients will be Type B toxin naive     patients with CD. During this study patients will receive repeat injections of MYOBLOC when     deemed appropriate by the Investigator. However, it will be recommended that injections occur     not more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be     targeted for at least two years, with potential exposure for up to 7 years in patients with     earliest enrollment   "
217827|NCT00702767|"     This study was completed in October 2006. No further participates are being recruited.   "
217828|NCT00702780|"     This study aimed to test whether escitalopram would slow the brain atrophy in patients with     mild to moderate AD over the 52-week period.   "
217829|NCT00702793|"     This is a 15 week trial to determine (1) the safety and tolerability of varenicline when used     for smoking cessation/reduction in individuals with schizophrenia; (2) if treatment with     varenicline affects the symptoms of schizophrenia.   "
217841|NCT00702949|"     RATIONALE: Pregabalin may help relieve hot flashes in women with a history of breast cancer     or those who have no history and do not wish to take estrogen therapy for fear of increased     risk of breast cancer. It is not yet known what dose of pregabalin may be more effective in     treating hot flashes.      PURPOSE: This is a randomized phase III trial to determine the efficacy of two doses of     pregabalin, in comparison to placebo, in the prevention of hot flashes.   "
217831|NCT00702819|"     Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed     countries around the world, and an increasing cause of blindness in developing countries.      The retina lines the inside of the eye. It functions as film within the camera which is the     eye. When an infant is born prematurely, the vascular network necessary to nourish the retina     has not fully developed. As a consequence, in some infants abnormal vessels proliferate     instead of the normal ones - a condition known as ROP. The abnormal vessels carry scar tissue     along with them, and may lead to retinal detachment and blindness if the eye is not treated.      The Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Study     demonstrated that ablation of the peripheral avascular retina reduced the risk of poor     structural and visual outcome due to retinal distortion or detachment in ROP (1980's). The     ablated retina is not functional and is not amenable to regeneration.      Peripheral retinal ablation is not universally effective in fostering regression of ROP. This     is particularly true for an aggressive form of ROP (aggressive posterior ROP, or APROP) which     typically afflicts profoundly premature and infirm neonates. In this subset of infants,     progression of ROP to bilateral retinal detachment and blindness occurs despite timely and     complete peripheral retinal laser ablation.      Rationale The development of ROP is largely dependent on vascular endothelial growth factor     (VEGF). When an infant is born prematurely the relatively hyperoxic environment the baby is     introduced to shuts down the production of VEGF. Retinal maturation is delayed. Subsequently,     at a time when intraocular VEGF levels would normally be declining late in the third     trimester of pregnancy, abnormally high levels of VEGF are seen due to large areas of     avascular retina and associated tissue hypoxia.      The availability of FDA-approved drugs for anti-VEGF treatment renders it possible to treat     such eyes off-label. Available drugs include pegaptanib sodium (Macugen) for partial blockage     of VEGF-A, or drugs such as ranibizumab (Lucentis) and bevacizumab (Avastin), which cause     complete blockage of VEGF-A.      As VEGF is required in the developing retina for normal angiogenesis, and our goal is not to     penetrate tissue, but to block the excessive levels of VEGF trapped within the overlying     vitreous which is responsible for the abnormal vasculature in ROP.      For purposes of this study the investigators have chosen bevacizumab (Avastin), which will:     a) attain complete blockage (vs. Macugen) of intravitreal VEGF-A, and; b) which is limited in     its ability to penetrate tissues because it is a full antibody (vs. Lucentis, an antibody     fragment specifically designed for better tissue penetration), and is more likely to restore     VEGF homeostasis within the developing retina.   "
217832|NCT00702832|"     The aim of this study is to assess if early supported vestibular rehabilitation can reduce     dizziness and improve daily life activities in patients with acute vestibular injury.      The study question is: Does early supported vestibular rehabilitation have an additional     effect on dizziness symptoms and daily life functions compared to standard treatment?   "
217833|NCT00702845|"     Clinical trial objectives are to investigate the efficacy and safety of a single injection of     100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for     controlled ovarian stimulation (COS), using daily recFSH as a reference.   "
217834|NCT00702858|"     This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases     joint and bone pain associated with Aromotase Inhibitor therapy (AIT).      Another purpose of the study is to find out if Blue Citrus improves how you feel while taking     AIT and if your quality of life improves.   "
217835|NCT00702871|"     Objective of this study was to determine incidence, risk factors, etiological micro-organisms     and their antimicrobial susceptibility pattern and outcome of VAP; and to study effect of     ranitidine vs. sucralfate, used for stress ulcer prophylaxis, on gastric colonization and on     occurrence of VAP.      Methods: Design: Prospective randomized study. Setting: ICUs of Medicine Department and     Anesthesiology Department, Maulana Azad Medical College and Lok Nayak Hospital, University of     Delhi, New Delhi. Patients: 50 patients of age more than 12 years, who had been on ventilator     for more than 48 hrs. Intervention: Endotracheal Aspirate and blood sample of all patients     were cultured to determine micro-organisms causing VAP and their antimicrobial susceptibility     pattern. Patients were divided into 2 groups on random basis. The first group was given     ranitidine for stress ulcer prophylaxis while the second was given sucralfate. Thereafter,     difference in gastric colonization (on basis of quantitative culture of nasogastric aspirate)     and on occurrence of VAP in both the groups was compared.      Study Hypothesis: Study was designed to create data about Ventilator associated pneumonia in     developing countries like India. This data is crucial for providing information for deciding     future guidelines for treatment of and prevention of Ventilator associated pneumonia. Further     to test the hypothesis that H2 blockers, by virtue of raising gastric Ph, increase gastric     colonization by pathogenic organism and increase incidence of Ventilator associated     pneumonia; patients were divided into two groups on random basis, as described above.   "
217836|NCT00702884|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with     relapsed or refractory esophageal or gastroesophageal junction cancer.   "
217837|NCT00702897|"     OBJECTIVE: To retrospectively analyze the results of ambulatory treatment on Taiwanese     patients with primary varicosities of the lower extremities including the use of endovenous     laser, phlebectomy, and sclerotherapy.      METHODS: We routinely used tumescent anesthesia and ultrasound-guided approaches for the     application of endovenous laser. Vein access was achieved by either a percutaneous or stab     wound. The laser power was usually 10 - 20 watts; laser treatment usually was begun from 4-10     cm below the saphenofemoral junction, and stopped around the knee, not over 10 cm below the     knee. In the same operation, we used Mueller's phlebectomy and/or sclerotherapy if there were     prominent branch varicosities. We instructed each patient to walk around immediately after     the operation, to go home, and to come back 1-3 days later for follow-up. Ultrasound scan and     venous function follow-up was scheduled at 1 month, 6 months, 12 months, and then annually.   "
217838|NCT00702910|"     This study will involve the use of a new medicine called GW642444 being developed for the     treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the     study is to see how safe and how well tolerated the study drug is when inhaled in two     different formulations as a fine powder by asthmatic patients. In addition, the study is     designed to examine the effect of the study drug on the lungs, how the study drug affects     parts of the body other than the lungs and to see how the body affects the study drug when it     is given in single doses.   "
217839|NCT00702923|"     The current protocol will evaluate the safety of combining treatment with     bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with     PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with     safety the primary endpoint. Secondary endpoints will be to determine whether prostate     associated immune responses are seen, and whether treatment is associated with an increase in     PSA doubling time and PSA recurrence at one year, as markers of clinical activity. Cohorts of     six patients will be treated in each dose level. The investigators hypothesize that     short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell     mediated tissue destruction that can be augmented with a monoclonal antibody blocking CTLA-4,     and that this will have therapeutic benefit in patients with recurrent prostate cancer.   "
217844|NCT00702988|"     The objective of this trial was to evaluate whether Org 36286 treatment for the induction of     multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro     fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant     subjects and their offspring.   "
217845|NCT00703001|"     The Waukesha Smiles Project will compare approaches to improve oral health habits and     increase access to basic dental care for low-income children in Waukesha, Wisconsin through a     school-based outreach program of oral health promotion, screening and referral.   "
217846|NCT00703014|"     The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the     induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS)     prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for     pregnant participants and their offspring. The primary endpoint was the take-home baby rate     calculated as the number of participants with an ongoing pregnancy in Base Trial P05787     (NCT00696800) with at least one live born infant relative to the number of participants in     the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer     (ET).   "
217847|NCT00703027|"     We tried to use data mining method to find out the new model of factors that affects the     progression of diabetes mellitus.   "
217848|NCT00703040|"     This first phase of a two-phase study involves three components:        1. Review of existing linkage-to-care protocols and sources of referrals for care;        2. Semi-structured telephone or face-to-face interviews with a minimum of two personnel per          site who are associated with linkage to medical care. (Preference will be given to          personnel with direct experience in linkage to care); and        3. Structured observations of referral sessions.   "
217849|NCT00703053|"     Severe disease in humans due to bird influenza viruses (H5N1) has led to concern that this     virus may result in a widespread outbreak of bird flu. The purpose of this study is to     evaluate the dose and dosing schedule for 2 different types of H5N1 vaccine. Participants     will be randomly assigned to 1 of 9 possible vaccine groups. All participants will receive 2     doses of Clade 1, Clade 2, or combination Clade 1 and 2 on Day 0. All participants will     receive a second dose of the same vaccine or a different vaccine type on study day 7, 14, 28     or 180. Study participants will include about 500 healthy adult subjects, ages 18-49 years     old, who have no history of prior H5 flu exposure or vaccination. Study procedures may     include medical history, physical exam, and blood sampling. Subject participation may last up     to 372 days. Several DMID studies have recently evaluated H5N1 vaccines in healthy adults,     04-063, 05-0090, 05-0015, and 05-0043.   "
217850|NCT00703066|"     The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already     publicly used vaccine against rabies. 30 Gabonese children aged 1-5 years will be enrolled     and randomly allocated to receive either malaria vaccine or rabies vaccine without the     investigator or the participants knowing what they received. They will receive 3 doses each     at one month intervals, and will be followed up for one year to evaluate safety parameters.     30 and 100µg doses for the candidate malaria vaccine GMZ 2 will be evaluated for safety.      This is the second time that candidate malaria vaccine GMZ 2 is being tested in Africa, the     first time being in Gabonese adults where the product was found to be safe.   "
217851|NCT00703079|"     To investigate the 60 month impact of surgery and somatostatin analogues (SSA) on glucose     metabolism in acromegaly we will analyzed data from 100 patients with acromegaly according     with different treatments (group A=with SSA only; group B= SSA followed by surgery; group C=     surgery only; group D= surgery followed by SSA). At diagnosis and after 6-12 and 60 months     were analyzed as primary outcome measure changes in fasting glucose and as secondary outcome     measures changes of glycated hemoglobin (HbA1c) and insulin levels, HOMA-R and HOMA-β,     representing insulin resistance and β-cell function, respectively.      We will enrol 100 patients and expect half of them to have IGT or diabetes mellitus. We do     not expect changes according with different treatment after 60 months while SSA-treated     patients might experience deterioration of glucose tolerance after 6-12 months. We intend to     look for predictors of deterioration of glucose tolerance.   "
217852|NCT00703092|"     The purpose of this study is to determine whether 6 months of fiber supplementation will     improve ovulation in women with polycystic ovary syndrome (PCOS).   "
217853|NCT00703105|"     The purpose of this study is to determine if an immune modifying drug (Ontak) alone or as     part of a vaccine therapy will produce remissions in patients with advanced ovarian cancer.     This research is being done because we want to find new therapies for treatment of relapsed     or refractory (resistant to ordinary treatment) ovarian cancer. The use of ONTAK and vaccine     therapy is research.      A new experimental approach for treating refractory or relapsed ovarian cancer involves using     the patients own immune system to kill the cancer cells. These immune cells are called     monocytes and are harvested from blood. The process of Leukapheresis collects the monocytes     called Dendritic Cells. This is usually a 3 hour process done in the comfort of a hospital     bed in the apheresis lab, similar to giving blood for donation. Approximately 300cc's are     collected during this process, the equivalent of about 10 ounces of blood. Once these     dendritic cells are collected - a special laboratory grows and processes them into a vaccine     using a patient's own tumor cells. This preparation is then given back to the patient     hopefully to stimulate the immune system to kill cancer cells. This type of treatment is     considered biological research.      This study also involves a drug called ONTAK, which is made using certain proteins from     diphtheria toxins and interleukin-2 (chemotherapy drug). This drug will act on immune     suppressing cells normally present in your body making vaccine therapy possibly less     effective. Ontak helps set up your immune system to be boosted by the vaccine injections. The     use of Ontak followed by the vaccine to stimulate your tumor killing immune cells has not     been done in ovarian cancer before and is research.   "
217854|NCT00703118|"     The purpose of this study is to determine the safety, efficacy and tolerability of using two     regimens of telaprevir (with and without delayed start) with standard treatment compared to     standard treatment alone in participants with chronic, genotype 1, hepatitis C.   "
217855|NCT00703131|"     The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study     the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal     fistulas.   "
217856|NCT00703144|"     The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients     with renal failure undergoing continuous veno-venous hemodiafiltration.   "
217857|NCT00703157|"     Prospective randomized interventional trial comparing the efficacy of circumferential     pulmonary vein ostia ablation using surgical versus catheter techniques in the treatment of     paroxysmal atrial fibrillation. Success rate determined by REVEAL-XT (AF implantable     monitoring device).   "
217871|NCT00703339|"     The purpose of this study is to establish single-dose tolerability of inhaled treprostinil     sodium in idiopathic pulmonary fibrosis (IPF) patients with pulmonary hypertension, and to     explore the acute hemodynamic effects over a range of tolerable doses. The safety and     pharmacodynamic information obtained from this study will inform the design and conduct of     future studies in inhaled treprostinil sodium in this population.   "
217895|NCT00703651|"     This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the     trivalent inactivated split virion influenza vaccine when administered by intradermal route     with that of the current pharmaceutical presentation administered by intramuscular route.      Primary Objective:      To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated     split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57     years.      Secondary Objective:      To evaluate the safety profile during the 21-day period following each vaccination in each     study group   "
217858|NCT00703170|"     Rationale:      The Mammalian Target of Rapamycin (mTOR) is a large polypeptide serine/threonine kinase of     289 kDa; kinases have been shown to be important regulators of cancer cell cycle,     proliferation, invasion, and angiogenesis, and mTOR has been shown to have a key role in the     signaling of malignant cell growth, proliferation, differentiation, migration, and survival.     Inhibition of mTOR would result in arrest of cell growth in the G1 phase of the cell cycle.      Temsirolimus (CCI-779) is a soluble ester analogue of rapamycin (sirolimus) which has shown     impressive in vitro and in vivo cytostatic activity in selectively inhibiting mTOR. In animal     models, temsirolimus has demonstrated an impressive cytostatic effect on a wide variety of     cancer cells. In vitro, it inhibited the growth of human T-cell leukemia, glioblastoma,     melanoma, prostate, breast, renal cell, and pancreatic cells, all of which showed particular     sensitivity to temsirolimus, with significant growth inhibition at concentrations of less     that 0.01micrometer. In Phase I trials, temsirolimus has been investigated as a single agent     on a weekly schedule as well as daily for 5 days every other week, and evidence of activity     was observed over the entire dose range (15 - 220 mg/m2) in patients with both breast and     renal cancer. There was no apparent relationship between exposure and clinical benefit,     suggesting that the inhibition of mTOR may be achieved at doses well below dose levels that     result in dose limiting toxicities. Major tumor responses were noted in Phase I trials in     patients previously treated with lung, breast, renal as well as neuroendocrine tumors. Minor     responses were noted in soft tissue sarcoma, endometrial, and cervical carcinoma.      Pegylated liposomal doxorubicin has been FDA approved for use in refractory metastatic     ovarian cancer and AIDS-related Kaposi's Sarcoma. It has also been shown to be effective in     previously treated metastatic breast cancer.      Combination studies in preclinical models suggest that rapamycin and its analogues are at     least additive in effect with standard chemotherapy and radiation. In addition, studies in     breast cancer cell lines suggest that the mTOR inhibitors may reverse resistance to     anti-estrogen agents. Thus, we are proposing that the combination of temsirolimus and     liposomal doxorubicin will be highly effective in metastatic solid tumor malignancies.      Objectives:      Primary        -  To define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of          temsirolimus in combination with pegylated liposomal doxorubicin in patients with          resistant solid malignancies.        -  To determine the incidence and severity of other toxicities of temsirolimus in          combination with pegylated liposomal doxorubicin in patients with resistant solid          malignancies.      Secondary        -  To assess the pharmacokinetic profile of temsirolimus in combination with pegylated          liposomal doxorubicin.        -  To determine any anti-tumor activity and response to the combination of temsirolimus and          pegylated liposomal doxorubicin in treatment of patients with resistant solid          malignancies.   "
217859|NCT00703183|"     The purpose of this study is to evaluate the safety and tolerability of a new investigational     drug (ACU-4429) in healthy human volunteers.   "
217860|NCT00703196|"     RATIONALE: Supplements, such as folic acid, may stop or delay the development of cervical     cancer in women infected with human papillomavirus.      PURPOSE: This phase II trial is studying how well folic acid supplements work in preventing     cancer in women infected with human papillomavirus.   "
217861|NCT00703209|"     The UT Southwestern Medical Center at Dallas would like to give you information about a     research study that is being done for patients with painful diabetic neuropathy and have not     responded to medical treatment. Doctors from the departments of Internal Medicine, Physical     Medicine and Rehabilitation, Neurology, Pain Management and Plastic Surgery are conducting a     research study to examine the effects of nerve decompression on decreasing the pain     associated with diabetic neuropathy and increasing the sensation at the bottom of the foot.   "
217862|NCT00703222|"     The investigators intend to test the safety, and immunologic and clinical efficacy of a     combination of 2 allogeneic neuroblastoma tumor cell line vaccines, one of which has been     genetically modified to secrete the cytokine/chemokine combination of IL-2 and lymphotactin,     in patients undergoing chemotherapy for newly diagnosed, high risk neuroblastoma who receive     single autologous stem cell rescue as consolidation therapy.      This protocol will be carried out as a Phase I/IIa study to evaluate the safety and toxicity     of adding a previously unstudied, unmodified, irradiated neuroblastoma cell line (SKNLP) to a     studied, safe dose of a gene modified, IL-2/Lptn secreting neuroblastoma cell line     SJNB-JF-IL2/Lptn to be given as a vaccine to patients diagnosed with high risk neuroblastoma.   "
217863|NCT00703235|"     Diabetic macular edema is a common cause of visual loss among diabetic patients. Studies have     demonstrated the role of vascular endothelial growth factor (VEGF) in the pathogenesis of     edema.      This study designed to evaluate the effect of Intravitreal injection of a recombinant     monoclonal anti-VEGF antibody, Bevacizumab, for treatment of diabetic macular edema.   "
217864|NCT00703248|"     Treatment options that increase immune function, such as Osteopathic Manipulation Treatment     (OMT) lymphatic techniques, may provide improved short or long term performance of the immune     system. However, the efficacy of OMT to boost immune function among people living with HIV     has not yet been examined in a controlled study. Our experiment is designed to examine the     short (45 minutes) term impact of OMT on the white blood cells counts of HIV positive men who     are either antiretroviral therapy (ART) naïve or have not taken ART for at least 12 months     prior to enrollment in the study.   "
217865|NCT00703261|"     The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose     Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.   "
217866|NCT00703274|"     The purpose of this study is to refine and evaluate the Preventing Recurrence of     Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC)     intervention. PROTECT DC is a program consisting of in-hospital education coupled with     community-based stroke navigators and is designed to reduce the rate of vascular events or     death in a population of underserved individuals with stroke.   "
217890|NCT00703586|"     Hypothesis: Intensification of current ARV regimens with maraviroc will result in more     complete suppression of viral replication, particularly in the gastrointestinal mucosa with     resultant reduction in markers of immune activation and improved GI immune reconstitution.   "
217891|NCT00703599|"     The purpose of this study is to determine whether intravenous administration of autologous     adipose stem cells is safe and beneficial in patients with type 1 diabetes.   "
217867|NCT00703287|"     The investigators wish to establish on a small scale the effectiveness of adding the     physiotherapy programme developed by Jean-Pierre Bleton to the present standard treatment for     cervical dystonia with a view to undertaking a larger UK-wide trial looking at overall     cost-effectiveness. Specifically, the investigators wish to establish:        1. Whether this specific physiotherapy program for cervical dystonia improves patient          outcomes in terms of neck position, pain, disability, and quality of life compared to          simple physiotherapy advice?        2. What is the minimal clinically important change in the new CDIP-58 quality of life          measure for cervical dystonia from a patient's perspective that could then be used to          plan a definitive trial of this technique?        3. What are the economic implications of the specialized physiotherapy programme?   "
217868|NCT00703300|"     This phase I trial is studying the side effects and best dose of bortezomib when given     together with decitabine in treating patients with acute myeloid leukemia. Bortezomib may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving bortezomib     together with decitabine may kill more cancer cells.   "
217869|NCT00703313|"     The primary objective of this study is to compare the concentration in human tears of     levofloxacin and the active comparators at 15 minutes, 2,6, 12, and 24 hours after     instillation of a single drop of medication.   "
217901|NCT00703729|"     The purpose of this study is to evaluate and compare clinical post-operative outcomes for     patients using active cooling and compression device and those using ice bags and elastic     wrap after acromioplasty or arthroscopic rotator cuff repair.   "
217872|NCT00703352|"     BACKGROUND: There is no clinical evidence supporting medical treatment for the failing     systemic right ventricle in patients with transposition of the great vessels with atrial     switch. Cardiac magnetic resonance studies have shown a significant degree of myocardial     fibrosis in right ventricles in the systemic position, which predisposes to systolic and     diastolic dysfunction. Aldosterone is a widely recognized neurohormonal marker involved in     the formation of myocardial fibrosis and the treatment with aldosterone antagonists has shown     a decrease in ventricular mass in hypertensive patients, presumably related to reduction of     myocardial fibrosis.      HYPOTHESIS: Low dose of eplerenone, a selective mineralocorticoid receptor blocker, in     patients with systemic right ventricle can reduce the ventricular mass by means of a     reduction in myocardial fibrosis, resulting in improved systolic function.      PATIENTS AND METHODS: Randomized, double blind, parallel clinical trial comparing eplerenone     (50mg daily) with placebo.      Study population: Adult patients (>18 years) diagnosed with repaired transposition of the     great arteries with atrial switch (Senning or Mustard techniques) routinely followed at a     tertiary referral center.      Duration: 12 months. Outcomes: Right ventricular mass, myocardial fibrosis mass and ejection     fraction assessed by cardiac magnetic resonance.   "
217873|NCT00703365|"     This study is to evaluate the efficacy and safety of Sorafenib in combination with     Gemcitabine in patients with advanced/unresectable HCC.   "
217874|NCT00703378|"     Primary Objective      1. To develop a pharmacokinetic-pharmacodynamic (PD) model for optimisation of docetaxel     dosing      Secondary Objectives        1. To establish an exposure-toxicity (neutropenia) relationship for docetaxel        2. To determine the exposure breakpoint for docetaxel toxicity based on a neutropenia PD          model        3. To identify demographic, pathophysiological and/or phenotypic covariates predicting          docetaxel clearance        4. To prospectively validate this PK-PD model for optimisation of docetaxel dosage and          determination PK variability and toxicity   "
217875|NCT00703391|"     The purpose of this study is to assess the tolerability (effect of drug on body) and     pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD   "
217876|NCT00703404|"     This study will evaluate the effectiveness of first-line HIV treatment (fixed-dose     combination of the generic antiretroviral drugs nevirapine, stavudine and lamivudine)     provided by the Malian National HIV Treatment Program. Antiretroviral therapy has become a     priority because of its proven effectiveness in decreasing sickness and death from HIV     infection. Reliable information on its efficacy is needed.      Patients 18 years of age and older who enter the Malian National HIV Treatment Program and     have not had prior antiretroviral treatment may be eligible for this study.      Primary Objective      The primary objective is to measure the virologic treatment response at 24 weeks to the     Malian-approved fixed-dose regimen (FDC) of nevirapine, stavudine and lamivudine (Triomune)     in patients who are na(SqrRoot) ve to antiretroviral therapy in Bamako, Mali compared to a     historical cohort as a prelude to further clinical research investigations in Mali.      Secondary Objectives        1. To assess the association of the 24 week response with the response at one year as          measured by suppression of viremia to less than 50 copies/mL        2. To evaluate the baseline clinical and HIV-associated characteristics of a cohort of          persons who are enrolled in protocol-mandated monitoring.      Participants undergo treatment in the government-sponsored program. Clinical visits are     scheduled at study days 0 (antiviral therapy start day) and 14, and at 1, 3, 6, 9 and 12     months. Patients undergo a medical history, including all confirmed and probably diagnoses     made since the previous visit and current status, physical examination and blood tests for     CD4 and viral load at each visit.      Study start date: July 2008   "
217892|NCT00703612|"     The purpose of this study is to determine whether intravenous administration of autologous     adipose-derived stem cells is of benefit in the management of types 2 diabetics.   "
217914|NCT00703898|"     Although nevirapine is used as an alternative to efavirenz for initial regimen in developed     countries, nevirapine has still been a key antiretroviral drug in many resource-limited     countries including Thailand due to its accessibility and affordability. In addition, a     component of stavudine and lamivudine is still widely used as a backbone in the     antiretroviral regimen in this setting.To date, data on the durability of a regimen of     stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited     settings.   "
217915|NCT00703911|"     This study was conducted in Africa, Europe, the Middle-East and South America. The primary     objective of this registry was to observe the use of single dose and multi-dose use of     activated recombinant human factor VII and to compare short-term outcomes, including     effectiveness, safety, quality of life and treatment satisfaction with the approved     treatments.   "
217877|NCT00703417|"     For this cross-sectional case control pilot study 30 women, 55-75 years old with type II     diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously     diagnosed by a physician, use of hypoglycemic medications, or fasting glucose > 126 mg/dl     (7.0mM) in accordance with the American Diabetes Association criteria. The diabetic patient     population will be divided into 2 groups: patients with status post low energy fractures of     the proximal humerus, the proximal femur, the ankle and the foot (n=10) versus diabetic     patients with no fractures or low energy trauma fracture history (n=10). An additional group     of 10 diabetic postmenopausal women will be recruited and will have magnetic resonance     imaging (MRI) of the lower back only. Caucasian, Asian and Hispanic women will be combined     since a previous study suggested that BMD is very similar in these 3 population and that     ethnic differences are minimal. In addition a population of 10 age-matched, BMI-matched,     race-matched healthy women, without osteoporotic fractures will be examined. In all of these     volunteers a medical history will be obtained to ensure good health status and rule out     chronic diseases that would have an impact on bone metabolism. Patients will undergo MRI, QCT     and high-resolution peripheral quantitative computed tomography (HR-pQCT) examinations to     determine bone mineral density and bone structure/quality.      The hypothesis of this pilot project is that type II diabetic patients with and without     low-energy fractures have a different trabecular bone architecture and composition, which is     also different when compared to normal age-matched healthy patients. Architectural     differences in these three patient groups may be visualized with high resolution MRI and     high-resolution peripheral quantitative computed tomography (HR-pQCT) and will be most     pronounced at the calcaneus and the distal tibia. Analyzing structure parameters obtained     from high resolution MRI and spectroscopy may improve our understanding of the     pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly     diabetic population.   "
217878|NCT00703430|"     Alzheimer's disease (AD), is associated with behavioral disturbances in approximately 50% of     AD patients in Beijing. Agitation, and aggression specifically, is considered the most     serious noncognitive symptom experienced in patients with dementia. Memantine is a recognized     treatment for Alzheimer's disease either alone or in combination with cholinesterase     inhibitors. Its efficacy in vascular dementia is also established. Family members continue to     play a central role in home care for the demented elderly in China. This proposal is to     conduct a study in Beijing, China to investigate the efficacy and safety of Memantine in the     treatment of agitation and aggression in AD patients. In addition, this proposal aims to     explore the impact of memantine on caregiver burden of AD patients in Chinese culture.   "
217879|NCT00703443|"     The purpose of this study is to determine the genetic basis of cardiomyopathies and heart     failure.   "
217894|NCT00703638|"     RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by     blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving sorafenib together with pemetrexed and cisplatin may kill more     tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when     given together with pemetrexed and cisplatin in treating patients with advanced solid tumors.   "
217880|NCT00703456|"     The aim of this study is to determine the effect of a balance training intervention on the     change in hyper-reactivity to unloading reaction, ankle joint laxity, ankle joint     proprioception and evertor muscle weakness in individuals with functional ankle instability     (FAI) using quantitative biomechanical and neuromuscular measurements.      We hypothesize that experimental FAI group will demonstrate a significant decline in     unloading reaction following balance training while FAI control group will not show a     significant decline in unloading reaction without training. We further hypothesize that     experimental FAI group will demonstrate a significant improvement in the FAI score after the     balance training measured by Ankle Instability questionnaire. Following balance training,     there will be a significant correlation between the change in FAI score and change in the     unloading reaction in the experimental group.   "
217881|NCT00703469|"     This study examines the safety, tolerability, and immunogenicity of a single dose of MDX-1106     in patients with active hepatitis C genotype 1 or mixed hepatitis C genotype infection.   "
217882|NCT00703482|"     The purpose of this study was to study the effect of different combinations of fenofibrate     and coenzyme Q10 on ventricular diastolic function in patients with Type II diabetes   "
217883|NCT00703495|"     The purpose of this study is to investigate the relationship among regional transcranial     oxygen saturation (rSO2), brain tissue oxygen pressure (PbtO2) and cerebral perfusion     pressure (CPP) in patients with severe traumatic brain injury (TBI).   "
217884|NCT00703508|"     1. The polycystic ovary syndrome is the major cause of infertility in the United States.          Metformin has been shown to increase frequency of ovulations in PCOS, and is used in          clinical practice to treat infertility, but some women with PCOS do not respond to          metformin treatment.        2. Knowing that a specific gene predicts the effect of metformin on ovulation would          facilitate more efficient and effective treatment of infertility in PCOS.   "
217885|NCT00703521|"     Background. The World Health Organization recommends pre-exposure vaccination (PreP) to     protect children living in canine rabies endemic countries. Including PreP in national     childhood immunization programs (EPI) is a viable option.      Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to     receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM     (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of     Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or     JEV alone was administered concomitantly one year after primary vaccination. Safety was     evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to     booster and on days 7 and 28 post-booster, and at two and three years post primary     vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA,     JEVNA).   "
217886|NCT00703534|"     This research study is being done to gather information about how to do further clinical     studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).   "
217887|NCT00703547|"     A single blind, randomized, placebo-controlled, crossover study in twenty four healthy male     subjects. Subjects will be divided into two cohorts with alternate panel design. The study is     investigating the safety, tolerability and pharmacokinetics of single oral escalating doses     of GSK586529.   "
217888|NCT00703560|"     The purpose of this study is to evaluate what happens to hepatitis C virus in response to     treatment with pegylated interferon and ribavirin in patients with HCV compared to those with     HIV and HCV.      This research is being done to help us identify how the composition of HCV changes with     interferon in different populations. We will examine how quickly HCV is cleared from your     body and what factors may influence that clearance. This information may help us find better     treatments for HCV.   "
217893|NCT00703625|"     Rationale:      The Mammalian Target of Rapamycin (mTOR) is a large polypeptide serine/threonine kinase of     289 kDa; kinases have been shown to be important regulators of cancer cell cycle,     proliferation, invasion, and angiogenesis, and mTOR has been shown to have a key role in the     signaling of malignant cell growth, proliferation, differentiation, migration, and survival.     Inhibition of mTOR would result in arrest of cell growth in the G1 phase of the cell cycle.      Temsirolimus (CCI-779) is a soluble ester analogue of rapamycin (sirolimus) which has shown     impressive in vitro and in vivo cytostatic activity in selectively inhibiting mTOR. In animal     models, temsirolimus has demonstrated an impressive cytostatic effect on a wide variety of     cancer cells. In vitro, it inhibited the growth of human T-cell leukemia, glioblastoma,     melanoma, prostate, breast, renal cell, and pancreatic cells, all of which showed particular     sensitivity to temsirolimus, with significant growth inhibition at concentrations of less     that 0.01micrometers. In Phase I trials, temsirolimus has been investigated as a single agent     on a weekly schedule as well as daily for 5 days every other week, and evidence of activity     was observed over the entire dose range (15 - 220 mg/m2) in patients with both breast and     renal cancer. There was no apparent relationship between exposure and clinical benefit,     suggesting that the inhibition of mTOR may be achieved at doses well below dose levels that     result in dose limiting toxicities. Major tumor responses were noted in Phase I trials in     patients previously treated with lung, breast, renal as well as neuroendocrine tumors. Minor     responses were noted in soft tissue sarcoma, endometrial, and cervical carcinoma.      Docetaxel is a taxane analog which is active against many solid tumors including breast,     non-small cell lung, prostate, gastric, ovarian, head and neck, and pancreatic cancers, soft     tissue sarcoma, and melanoma. It has been shown in several Phase III studies to have     clinically significant activity in several solid tumors.      We propose treating patients with resistant solid malignancies with docetaxel and     temsirolimus. In a study using human breast cancer cell lines, mTOR inhibition with rapamycin     had a synergistic cytotoxic effect with paclitaxel. Given the novel mechanism of action of     mTOR inhibitors and known synergistic activity of an mTOR inhibitor, rapamycin, with a     taxane, paclitaxel, in vitro, we envision that this regimen would be highly active in     patients with solid tumor malignancies.      Objectives:      Primary        -  To define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of          temsirolimus in combination with pegylated liposomal doxorubicin in patients with          resistant solid malignancies.        -  To determine the incidence and severity of other toxicities of temsirolimus in          combination with pegylated liposomal doxorubicin in patients with resistant solid          malignancies.      Secondary        -  To assess the pharmacokinetic profile of temsirolimus in combination with pegylated          liposomal doxorubicin.        -  To determine any anti-tumor activity and response to the combination of temsirolimus and          pegylated liposomal doxorubicin in treatment of patients with resistant solid          malignancies.   "
217896|NCT00703664|"     This phase II trial studies how well bortezomib and vorinostat work in treating patients with     recurrent mantle cell lymphoma or recurrent and/or refractory diffuse large B-cell lymphoma.     Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.   "
217902|NCT00703742|"     The purpose of this study is:        1. to find out the structural or functional effects of selective serotonin reuptake          inhibitors (SSRI) in major depressive disorder (MDD);        2. find special abnormalities in depression secondary to other disease, e.g., autoimmune          disease like systemic lupus erythematosus (SLE).        3. find the relationship between the efficacy of antidepressant and the change of          neuroimaging in MDD        4. to find possible predispose to MDD        5. to explore the DNA methylation status in depression;   "
217903|NCT00703755|"     The purpose of this study was to study the effect of different combinations of fenofibrate     and metformin on the cluster of metabolic syndrome (MetS) biochemical abnormalities, and to     determine the dose combination allowing normalization of MetS patients.   "
217904|NCT00703768|"     The purpose of this study is to evaluate if there is a difference in quality of life (as     measured by FACT-P) in patients treated with androgen deprivation therapy (ADT) for     biochemical failure (PSA recurrence) following surgery or radiation for prostate cancer     depending on when ADT is initiated.   "
217905|NCT00703781|"     Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery   "
217906|NCT00703794|"     The data collected in this study will be used to support International Regulatory     submissions. The study objective is to evaluate the continued safety and efficacy of the     AXIUM Progressive Coil System.      This Device has been used clinically at approximately 150 Institutions under FDA 510(k)     clearance since April 24, 2007. The device received CE authorization on June 30, 2007.     Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.   "
217907|NCT00703807|"     Endometrial cancer is the most common malignancy of the female reproductive tract. The     majority of patients with endometrial cancer are diagnosed at an early stage and cured with     surgery with or without adjuvant radiotherapy. However, a significant number of patients     present with metastatic disease outside of the pelvis or develop recurrent disease after     primary therapy.      mTOR inhibitors have been shown to be promising agents in reducing tumor growth in vitro and     in vivo, in several solid cancers. Inhibitors of mTOR are primarily cytostatic in cancer     cells; combination therapy with cytotoxic chemotherapeutics and other biologic agents may     prove to be the most advantageous use of these drugs. mTOR inhibition with a rapamycin     analogue demonstrated in vitro antiproliferative activity on endometrial AN3 CA and HEC-1-A     tumor cells, and this inhibition of proliferation was found to be concentration dependent.     Topotecan is an active agent in the treatment of advanced and recurrent endometrial cancers.   "
217908|NCT00703820|"     The purpose of this study is to assess the feasibility and efficacy of a novel form of     therapy—haploidentical NK cell transplantation—in patients with standard-risk AML. In     addition, we will investigate the efficacy of clofarabine + cytarabine (Clo/AraC) in newly     diagnosed patients with AML and attempt to optimize outcome through the use of MRD-adapted     therapy and further improvements in supportive care.   "
217909|NCT00703833|"     The study will look at the effectiveness of MK0777 in patients with Generalized Anxiety     Disorder.   "
217910|NCT00703846|"     Extina (ketoconazole) Foam, 2% was approved for marketing in the United States (US) in June     2007. Extina foam is indicated for topical treatment of seborrheic dermatitis in     immunocompetent patients 12 years of age and older. The approved dosing regimen is twice     daily for 4 weeks. The treatment of recurrent seborrheic dermatitis demands a topical     preparation that is safe for both short-term and chronic application. This study is being     conducted in order to obtain long-term safety data on the use of Extina (ketoconazole) Foam,     2% in the treatment of seborrheic dermatitis.   "
217911|NCT00703859|"     This is a study to see whether radiotherapy plus chemotherapy (Temozolomide) plus     Dichloroacetate (DCA) improves overall survival and offers better control of the disease in     patients with newly diagnosed Glioblastoma Multiforme Tumours.   "
217912|NCT00703872|"     A Phase II, Open Label, Multi-Center, Proof-Of-Concept Study determing whether treatment with     HDV-Interferon (HDV-IFN), by oral or subcutaneous (injection) routes, and ribavirin results     in similar efficacy [Rapid Virologic Response (RVR)] and safety as the reported efficacy and     safety with pegylated alpha-interferon-2a and ribavirin (historical control) in patients with     chronic hepatitis C (treatment naïve by oral route and non-responders by SC route     respectively).   "
217913|NCT00703885|"     The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy     controls to examine the acute effects of certain anxiolytic medications on brain function.   "
217916|NCT00703924|"     This study is to determine the effectiveness and safety of WR 279,396, a topical cream for     the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo     control under double-blind conditions in a local population group in Tunisia where     leishmaniasis is endemic.   "
217917|NCT00703937|"     The objective of this study is to evaluate the safety of FCM in patients with anemia who are     not dialysis dependent.   "
217918|NCT00703950|"     The aim of this study is evaluates the effect of the use of bottle and cup in breast sucking     patterns in preterm infants. It will be a randomized blind study. One group will be     randomized to use bottle to feed and another one to use a cup to feed. As secondary     endpoints, weight gain, days of life to begin full oral feeding, length of hospital stay and     breast feeding rates will be observed.   "
217946|NCT00704327|"     The purpose of this study is to evaluate whether or not cerebral atrophy scores obtained from     a brain MRI can correlate with Cognitive Test results. These results hope to demonstrate a     link between cerebral ischemic/degenerative changes shown on the MRI and cognition functions     results.   "
217919|NCT00703963|"     Patients who receive a mechanical heart valve to replace a diseased heart valve must take an     anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation.     Until recently, the testing of the level of anticoagulation was performed at medical     laboratories or hospitals.      The purpose of this study is to see if patients who test their level of anticoagulation by     themselves at home and then call their doctor with the result have better control of their     anticoagulation as compared to patients whose anticoagulation is checked only by their     physician.   "
217920|NCT00703976|"     The purpose of this study is to compare the effects (good and bad) of chemoradiotherapy with     or without Bevacizumab (Avastin). Chemoradiotherapy is the combination of chemotherapy (the     drugs pemetrexed and cetuximab) and radiation. Pemetrexed is not approved by the Food and     Drug Administration (FDA) for head and neck cancer when used in combination with radiation     therapy. Cetuximab is also approved by the FDA for head and neck cancers in patients who have     failed other chemotherapy treatments. Bevacizumab is approved by the Food and Drug     Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of     chemotherapy. In this study, the use of bevacizumab is investigational.   "
217921|NCT00703989|"     Benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental     diabetic retinopathy and incipient nephropathy in these models. In cultured vascular cells,     it also reduces aldose reductase gene expression, activity, and sorbitol levels. It does so     by activating the enzyme transketolase. α-lipoic acid, a potent antioxidant, has also been     reported to reduce both diabetic microvascular and macrovascular complications in animal     models. To determine whether benfotiamine in combination with α-lipoic acid would normalize     markers of ROS-induced pathways of complications in humans, we performed a pilot study in     subjects with Type 1 diabetes using one daily dose of benfotiamine in combination with     α-lipoic acid.   "
217922|NCT00704002|"     This is a prospective, randomized, multi-center pilot study of isolated, displaced neck     fractures of the fifth metacarpal. The patients are randomly assigned to osteosynthesis with     antegrade intramedullary splinting or conservative treatment.   "
217923|NCT00704015|"     The purpose of this study was to evaluate if an intervention with smoking cessation starting     during the acute hospitalization period and continuing during the acute postoperative phase     of 6 weeks would reduce the frequency of overall postoperative complications and wound     infections in patients with acute musculoskeletal injuries requiring surgical treatment. The     secondary aims were to study the short and the long term (1 year) abstinence rate, functional     outcome, health related quality of life as well as costs.   "
217924|NCT00704028|"     The objective of this study is to evaluate the safety of FCM in patients with anemia who are     not dialysis dependent.   "
217925|NCT00704054|"     Ridaforolimus (Deforolimus, AP23573, MK-8669) is an mTor inhibitor shown to have promising     activity in adults with a variety of solid malignancies, particularly the sarcomas. To date,     no studies to evaluate appropriate dosing or to obtain pharmacokinetic data in pediatric     patients have been conducted. Sarcomas are the second most common solid malignancies in     children and young adults, and for those patients with recurrent or refractory disease, new     therapies are needed. This initial evaluation of ridaforolimus will help define appropriate     dosing and toxicity evaluations, as well as establish the first pharmacokinetic and biologic     correlative data in pediatric patients treated with ridaforolimus.   "
217926|NCT00704067|"     The 12-month study will investigate a cognitive training augmentation of supported employment     to improve cognitive performance and work outcomes, which are expected to result in improved     quality of life and community integration for veterans with mild to moderate traumatic brain     injuries. The primary hypothesis is that compared to veterans who receive enhanced supported     employment, those who receive supported employment plus cognitive training will work more     weeks during the 12 months.   "
217927|NCT00704080|"     The purpose of this study is to determine the safety and tolerability of XL765 in combination     with Temozolomide in adults with anaplastic gliomas or glioblastoma on a stable Temozolomide     maintenance dose. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In     preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce     apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown     to inhibit the growth of tumor cells. Temozolomide (TMZ, Temodar®) is an orally administered     alkylating agent with activity against malignant gliomas. It is approved by the Food and Drug     Administration for the following indications: 1) treatment of newly diagnosed glioblastoma     multiforme (GBM) patients when given concomitantly with radiotherapy and then as maintenance     treatment; 2) refractory anaplastic astrocytoma (AA), ie, patients who have experienced     disease progression on a drug regimen containing nitrosourea and procarbazine. Temozolomide     is commonly used in the treatment of other anaplastic gliomas (AG) including oligodendroglial     tumors and mixed gliomas.   "
217941|NCT00704262|"     There are few therapies suitable for the treatment of psoriasis on the face and skin folds.     As these areas are sensitive, irritation and other adverse reactions are more common than     elsewhere on the body. The purpose of the study is to monitor the effect of once daily     treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus     hydrocortisone 10 mg/g on the hypothalamic-pituitary-adrenal axis and on the calcium     metabolism in patients with psoriasis vulgaris on the face and on the intertriginous areas   "
217928|NCT00704093|"     Right ventricular (RV) apical pacing induces a left bundle branch block (LBBB) type     electrical activation sequence in the heart. This abnormal activation pattern of the     ventricles may have detrimental effects on cardiac structure and function. RV pacing has been     shown to impair left ventricular (LV) function both in normal and failing hearts.     Importantly, it has been demonstrated that this deterioration in LV function is related to     the presence of LV dyssynchrony during RV pacing.      The exact effects of RV pacing on myocardial perfusion, oxidative metabolism and cardiac     efficiency have not been fully elucidated. The objective of the present study is to evaluate     the effect of RV pacing on both global and regional oxidative metabolism and perfusion, and     myocardial efficiency. In addition, the effect of RV pacing induced LV dyssynchrony on     myocardial oxidative metabolism and efficiency will be studied.      Our hypothesis is that LV dyssynchrony during RV pacing results in regional abnormalities in     LV perfusion and oxidative metabolism. LV dyssynchrony will also result in altered myocardial     efficiency.   "
217929|NCT00704106|"     We propose a largely retrospective study with short-term prospective follow-up in a subgroup     of patients who have not yet been treated with 48 weeks of entecavir following partial     response to adefovir. The aim of the study is to describe sequential virologic response to     adefovir and entecavir.   "
217947|NCT00704340|"     DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and     spinal procedures. This study was completed to further evaluate the safety of the DuraSeal     Sealant in a post-approval setting as compared to control (defined as methods typically     employed by surgeons to seal the dura).   "
217930|NCT00704119|"     RhuDex® (code number AV1142742) is a novel, orally bioavailable, low molecular weight     modulator of co-stimulation of T lymphocytes. RhuDex® binds to the protein CD80 (also known     as B7-1) on the surface of antigen-presenting cells and inhibits its interaction with CD28     (but not with CTLA-4) presented by CD4+ T lymphocytes.      RhuDex® is being developed for the treatment of rheumatoid arthritis. To improve oral     bioavailability, the study drug has to be co-administered with an alkaline buffer that     increases gastric pH values. In previous in vitro and phase I studies, meglumine has been     identified as the most effective buffer. Study CT 5002 is designed to evaluate the     bioavailability of four increasing doses of RhuDex®, combined with a fixed amount of     meglumine using a tablet formulation, under fed and fasted conditions as well as with     co-administration of the proton pump inhibitor pantoprazole. Furthermore, dose/plasma     concentration proportionality for single dosing and accumulation effects for repeat dosing of     RhuDex® will be evaluated.   "
217931|NCT00704132|"     A clinical study to determine the safety, efficacy and the way sitagliptin works in patients     with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.   "
217932|NCT00704145|"     A prospective Optical Coherence Tomography (OCT) study on the completeness of strut coverage     and vessel wall response, at different time points (3-6-9 Months), following TAXUS Liberte     stent implantation (staged procedures) in patients with multi vessel native coronary artery     lesions   "
217933|NCT00704158|"     This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally     advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV)     once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose     (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally     advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial     to further evaluate the safety and efficacy of CR011-vcMMAE.   "
217934|NCT00704171|"     To further characterize the PleuraSeal Sealant System as compared to standard of care     (sutures and staples only) in subjects undergoing an elective pulmonary lobectomy and     segmentectomy via open thoractomy.   "
217935|NCT00704184|"     A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered     with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response     (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in     participants with chronic HCV infection. The primary hypothesis was that the proportion of     participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater     than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were     co-administered with Peg-IFN/Ribavirin.   "
217936|NCT00704197|"     The purpose of this study is to characterize differences in the structure and function of the     body fat from two different parts of the body in young, healthy men and women. We will also     compare how differences in metabolism relate to characteristics of body fat and its     functions.   "
217937|NCT00704210|"     Objective To demonstrate the effectiveness of a conservative treatment approach for chronic     low back pain that addresses the underlying problem of intervertebral disc lesions and     degenerative disc disease, namely vertebral pressure on vital structures of the lumbar     region.   "
217938|NCT00704223|"     This study is conducted in Europe. The aim of this observational study is to evaluate the     incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions     in Austria.   "
217939|NCT00704236|"     The purpose of this study is to evaluate the efficacy of Traditional Chinese Treatment(TCT)     on insulin sensitivity and other related factors in type 2 diabetes by using an double-blind,     randomized, parallel control and prospective study This traditional compound Chinese herb     preparation is referred to this study, with three kinds of plants: 50 mg of Coptis Chinensis,     30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica, all of which are selected     by The Chinese Academy of Medical Sciences among those traditionally considered effective and     safe in the treatment of diabetes.      Patients enrolled were randomized into TCT group and placebo group administrated with TCT and     placebo respectively. Glucose disposal rate (GDR), fasting plasma glucose (FPG), postprandial     plasma glucose (PPG), HbA1C and other metabolic components were assessed at baseline and end     point   "
217940|NCT00704249|"     This study aims to compare the trough plasma concentrations of nevirapine after 7 days of     treatment at the full dose from baseline with dose escalation in patients taking efavirenz     who switch to nevirapine due to neuropsychiatric adverse reactions.   "
217942|NCT00704275|"     To compare the efficacy, safety and tolerability of 0.05% topical cyclosporin eye drop to     Refresh in moderate to severe dry eye patients. Null hypothesis is: there is no difference     between these two groups.   "
217943|NCT00704288|"     The purpose of this study is to evaluate the objective response rate and 6-month     progression-free survival rate of XL184 in subjects with recurrent or progressive     glioblastoma multiforme. XL184 is a new chemical entity that inhibits VEGFR2, MET and RET,     kinases implicated in tumor formation, growth and migration.   "
217944|NCT00704301|"     Delirium in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to     investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol     shortens the duration of delirium in comparison to placebo added to the treatment with     haloperidol.   "
217945|NCT00704314|"     We aimed to address the issue whether statins affect insulin resistance. To this end, we     combined the available state-of-the art technology for detailed assessment of both whole-body     and tissue specific insulin sensitivity in vivo in humans (euglycemic-hyperinsulinemic clamp,     stable isotope [6,6-2H2]glucose dilution technique, proton nuclear magnetic resonance     spectroscopy - 1H MRS - of liver and skeletal muscle). Outcome measures were determined     before and after 8 weeks therapy with 80 mg Simvastatin in hypercholesterolemic patients with     type 2 diabetes.   "
217951|NCT00704392|"     The purpose of this study is to determine the safety, tolerability, and highest safe doses of     XL647 in combination with XL147 in adults with solid tumors. XL647 is a small molecule that     potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), and ErbB2. XL147     is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to     inhibit growth and induce apoptosis (programmed cell death) in tumor cells.   "
217952|NCT00704405|"     The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of     Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary     hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily     (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC)     participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of     study therapy (SVR24).   "
217953|NCT00704418|"     Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery   "
217954|NCT00704431|"     Subjects will receive their first dose of darapladib in the clinical research unit (CRU), and     the remaining 9 days of dosing will occur at home. Subjects will record any adverse events     throughout the dosing period in a paper diary. Subjects will return to the CRU 10-14 days     after the last dose of darapladib for a follow-up visit. The total study duration for each     subject including the screening, treatment and follow-up periods will be approximately 4     weeks.   "
217955|NCT00704444|"     This study is a non-interventional (observational) study in Japan to confirm the safety and     efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs     in daily medical practice throughout a 12-week period. It is being conducted as a     post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's     guideline on Good Post-marketing Study Practice.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
217956|NCT00704457|"     Urine will be collected and sent to the University of Maryland. Urines will be analyzed for     urine markers.   "
217957|NCT00704470|"     In Intensive Care Medicine, critical incidents are not rare and may result in fatal outcome.     High fidelity patient simulators are commonly used in training curricula for healthcare     professionals especially in anesthesiology, emergency medicine, and intensive care medicine.     Several different course concepts have previously been published. As we know from recently     published data, up to 80% of all critical incidents in the field of medicine are caused by     human error. The authors of the present study aimed to investigate the effects of two     different course concepts (one addressing technical skills in intensive care medicine and on     addressing non-technical skills) on stress and performance. Stress and performance are     measured in a pre-intervention and a post-intervention testing scenario.   "
217958|NCT00704483|"     This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum     phosphate levels in Chronic Kidney Disease patients on hemodialysis   "
217959|NCT00704496|"     The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a     decongestant, will decrease nasal congestion leading to increased patency of the nose and a     decrease in nighttime sleep fragmentation in individuals with year round perennial allergic     rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and     fatigue.   "
217960|NCT00704509|"     The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance     phase of schizophrenia compared to placebo.   "
217961|NCT00704522|"     Patients receiving a patient assistance program during therapy for Hepatitis C will be     enrolled into this study. All patients will receive PegIntron pen and Rebetol according to     label and the patient assistance program. This study will be compared to similar studies from     other clinics using various patient support programs for the purpose of designing future     comparative phase IV studies.   "
217962|NCT00704535|"     The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of     Ezetimibe when used alone or in combination with a statin in patients with     hypercholesterolemia   "
217963|NCT00704548|"     Few trials have investigated the hypotensive effect of the Statins. Most were not     specifically aimed at this pleiotropic effect or had methodological problems. The possible     hypotensive effect may explain part of the favorable results of the Statins use on     cardiovascular prevention independently from its action on the cholesterol profile.      The purpose of this study is to determine the effect of Simvastatin on the blood pressure   "
217964|NCT00704561|"     The objective of this study is to evaluate the completeness of struts coverage and vessel     wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR     drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform)     implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction     (STEMI). To investigate the completeness of the coverage as well as the number of uncovered     stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high     resolution (~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.   "
225446|NCT00796627|"     This research is being done to increase knowledge about wound healing and different factors     that may affect healing in burn patients.   "
217965|NCT00704574|"     This observational study is conducted in Europe. The trial aims to observe the incidence of     serious adverse drug reactions in children and adolescents with type 1 diabetes during     Levemir® treatment.   "
217966|NCT00704587|"     The purpose of this study is to investigate every possible applicability of flow cytometrical     analysis in the intracellular detection of tumor-related material in activated macrophages in     the broadest range of cancer types.   "
217967|NCT00704600|"     The aim is to study safety and activity of nelfinavir , added to standard chemoradiotherapy     in patients with locally advanced rectal cancer. Furthermore analysis of the effect of     nelfinavir combined with chemoradiation on tumour tissue will be studied   "
217968|NCT00704613|"     The planning target volume (PTV) and planning organ at risk volume (PRV) margins used for     pediatric radiation therapy are empiric, and quantitative assessment of these margins is     needed to improve therapy planning and delivery.   "
218015|NCT00692393|"     This study compares primary resection with anastomosis and Hartmann's procedure in an adult     population with acute perforated colonic diverticulitis (Hinchey Stage III and IV) METHODS:     The primary end point was postoperative mortality. Secondary end points included surgical and     medical morbidity, operative time, and length of postoperative hospitalization.   "
217969|NCT00704626|"     Under normal conditions our immune system protects us against infections and tumors. The     immune system does this by recognizing that the infecting organism or the tumor is foreign to     the body and attacking it. One way the immune system attacks a foreign target is by making     proteins called antibodies that bind to the target. Sometimes, for reasons we poorly     understand, the immune system wrongly identifies part of our own body as being foreign and     attacks it. This can result in disease such as some forms of diabetes and thyroid disease, as     well as some neurological diseases. In this study, one tablespoon of blood will be removed     from each subject and tested to see if the immune system is making antibodies against     components of the nerves and muscles. We also hope to learn if these antibodies contribute to     the development or worsening of illnesses of the nervous system. Only one blood draw is     required, but subjects may be asked to give up to 8 additional blood samples to see if the     level of antibodies changes over time. Any additional blood draws would be performed at     regularly scheduled clinic visits. There would be at least 3 months between blood draws over     a period of up to 3 years, if requested by the physician.      Depending on your diagnosis, the physician may also request the collection of mouth (buccal)     cells. This takes about one minute and is painless. The cells are collected by swishing a     swab around your mouth. This cheek swab would be done with each blood draw.      Please note that this study is conducted ONLY at UC Davis and that all participants must be     seen in our clinic located in Sacramento, CA. Results of the testing performed in this study     are not given to the participants. This study is not intended to treat or diagnose any     condition.   "
217970|NCT00704639|"     This is a Phase II study of cetuximab, carboplatin and radiotherapy (RT) in patients with     Locally Advanced Head and Neck Carcinomas (LAHNC) who are unfit for cisplatin.      The aim of this study is to show the feasibility and safety profile of the combination of     cetuximab, carboplatin and RT in treatment of patients with LAHNC.   "
217971|NCT00704652|"     The purpose of this study is to determine whether systemic administration of darbepoetin     alpha results in the progression or regression of diabetic macular edema.   "
217972|NCT00704665|"     Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It     has ani-fibrotic properties. Previous studies have shown that relaxin is safe at     concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if     skin improvement and improvement in functional ability can be achieved.   "
217973|NCT00704678|"     This study will determine the titration regimen for SBR759 compared to sevelamer HCl in     lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis   "
217974|NCT00704691|"     The purpose of this study is to:        -  assess the effectiveness of lenalidomide for the treatment of patients with relapsed and          or refractory peripheral T-cell lymphomas; and,        -  assess the safety of lenalidomide.      There are reports suggesting a therapeutic benefit of thalidomide in patients with refractory     and/or relapsed Non-Hodgkin's Lymphoma's (NHL) which have led to the formal investigation of     lenalidomide in the treatment of relapsed NHL's.   "
217975|NCT00704704|"     Study Objectives The aim of the study is to evaluate the safety and efficacy of the     combination of 5-Aza-Cytidine + Thalidomide on the course of hrMDS patients.      Primary end point:      • To evaluate the overall response rate (CR+PR) of the combination of 5-Aza-Cytidine +     Thalidomide in hrMDS patients (INT-2 and High risk as defined by IPSS).      Secondary end points:        -  To evaluate the safety of the combination of Thalidomide+5-Aza-Cytidine in high risk MDS          patients.        -  Hematological improvement rate.        -  Cytogenetic response.        -  Progression free survival (PFS).        -  Quality of life assessment (FACT: MDS and peripheral neuropathy QOL Questionnaires).      Study design:      This is a multicenter, phase II, single arm study designed to evaluate the safety and     efficacy of the combination of Thalidomide+5-Aza-Cytidine in high risk MDS patients (INT-2     and High risk defined by IPSS) who are older than 18 years of age. Potential study subjects     will sign an informed consent prior to undergoing any study related procedure. Number of     patients to be enrolled 50.      Treatment plan: 5-aza-cytidine (75 mg m2/d) will be injected subcutaneously in 5-day cycle     every 28 days, for a total of 12 cycles.      Thalidomide will be given at the dose of 50 mg/d, from day 1 until for 6 months together with     5-aza-cytidine .      Treatment period includes 5-aza-cytidine (75 mg m2/d) will be injected subcutaneously in     5-day cycle every 28 days. Total number of 12 cycles or until progression or toxicity. Cycle     delay of maximum 2 weeks in case of hematological toxicity grade 3-4 at investigator     discretion.      Duration of the follow up period is 6 months. Duration of study The duration of the treatment     period is approximately 12 months. This time is required to complete the treatment, and to     determine the safety profile and the response rate. The duration of the Follow period will be     approximately a half year. The occurrence of PD will determine the duration of     progression-free survival of each patient.   "
217976|NCT00704717|"     The objective of this study is to evaluate patient satisfaction in hepatitis C patients     receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is     correlated with adherence to the prescribed regimen which, in turn, is affected by the ease     of use and accuracy of treatment administration. Since the PegIntron pen is a novel device,     the results of this study will be used to improve the training of patients and healthcare     providers in PegIntron pen use.   "
217996|NCT00704990|"     Attention deficit/hyperactivity disorder (ADHD) is a chronic neurobehavioural disorder often     diagnosed in childhood years. Complementary/alternative treatments including natural health     products (NHPs) are used by children with ADHD despite limited information on their safety or     usefulness. Some evidence suggests children with ADHD have a greater need for zinc,     magnesium, vitamin B6 and vitamin C. This study will supplement a small number of children     diagnosed with ADHD with therapeutic levels of these nutrients over 10 weeks to get a better     understanding of the safety and possible benefit of using these nutrients to treat symptoms     associated with ADHD.   "
217977|NCT00704730|"     The purpose of this research study is to evaluate the progression-free survival (PFS) with     XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally     advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to     receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits     VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.      The Clinical Steering Committee for this study, comprised of study doctors who specialize in     medullary thyroid cancer, has provided guidance regarding the design of the study. The     committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven     Sherman, MD.   "
217978|NCT00704743|"     Displaced fractures of the distal radius requiring closed reduction (otherwise known as     Colles fractures) are common in the emergency department. The purpose of the study is to     determine if there is any difference between 3 methods of immobilization for these fractures:     circumferential cast, volar-dorsal splint, and modified sugar tong splint. Maintenance of     position was assessed at 4 weeks after the injury and wrist strength and function were     assessed at 2 months and 6 months. We hypothesize that there will not be a clinically     important difference between these methods of immobilizing for displaced fractures of the     distal radius requiring closed reduction.      Extended description of the protocol, including information not already contained in other     fields.      Objectives:      Primary: To determine the effectiveness of three immobilization methods (circumferential cast     [CC], volar dorsal splint [VDS], modified sugar-tong [MST] splint) in maintaining the     position of displaced distal radius fractures after successful closed reduction.      Secondary to assess long term functional outcomes associated with fiberglass splint     immobilization versus standard cylindrical casting in patients maintaining initial     non-operative reductions.      Design: Randomized prospective single blind controlled trial Patients/Participants: Patients     over 18 years of age who presented to the emergency department with a displaced fracture of     the distal radius, requiring closed reduction.      Outcome Measurements: Loss of reduction (radiological slippage or the need for surgical     fixation during the 3-4 week primary immobilization period after initial successful     reduction). Secondary outcomes were DASH score, return to work, activities of daily living     (ADL), wrist pain, range of motion (ROM) and grip strength.      Study Phase Phase 3 Study Type Interventional - Assigned to treatment Recruitment status     Completed 2003 Record Verification Date March 2003 Anticipated trial start date November 1998     Last Follow-Up Date December 2002 Data Entry Closure Date January 2004 Study Completion Date     July 2004 Purpose Treatment Allocation Randomized      Masking Single Blind Control Active Assignment Parallel Endpoints Efficacy Primary outcome     Radiologic slippage of fracture at 4 weeks post reduction      Key secondary outcomes Functional outcomes: DASH score, return to work, activities of daily     living (ADL), wrist pain, range of motion (ROM) and grip strength   "
217979|NCT00704756|"     This is an observational study of patients undergoing treatment with PegIntron and Rebetol     for chronic hepatitis C in clinical practice in Belgium. Treatment will not be administered     as part of the study. Safety parameters will be assessed retrospectively. Efficacy     parameters, such as relapse rates and sustained virologic response rates, will be assessed     prospectively. The objective of the study is to examine any associations between safety,     virologic, histologic, demographic parameters and patient outcome (relapse rates and     sustained virologic response rates).   "
217980|NCT00704769|"     Evaluate the safety and general clinical response of desloratadine syrup in the relief of     symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.   "
217981|NCT00704782|"     The purpose of this study is to assess the safety and efficacy of Dimebon in combination with     donepezil (Aricept) in the treatment of Alzheimer's disease.   "
217982|NCT00704795|"     In order to evaluate the potential role of the gastrointestinal (GI) tract in the     postprandial hyperglucagonemia, which characterizes type 1 diabetes mellitus (T1DM) (as well     as type 2 diabetes mellitus (T2DM)), we wish to investigate the secretion of glucagon in     patients with T1DM without residual beta-cell function during 50-g oral glucose tolerance     test (OGTT) and during isoglycemic iv glucose infusion. By evaluating C-peptide negative     patients with T1DM we aim to describe the glucagon response to glucose (+/-stimulation of the     GI tract) independently of the potentially very important regulation of glucagon secretion by     endogenous insulin secretion. A more detailed understanding of the inappropriate glucagon     secretion in T1DM is highly needed in order to establish new intervention strategies in the     future treatment of the growing numbers of T1DM patients.   "
217983|NCT00704808|"     The purpose of this surveillance is to collect more safety and efficacy data in non-study     patients during concomitant and adjuvant temozolomide therapy.   "
217984|NCT00704821|"     Formation of new blood vessels (angiogenesis) is important for tumor growth in advanced     cancer. It is known that tumors make a protein called vascular endothelial growth factor     (VEGF). VEGF stimulates the formation of blood vessels that supply the tumor with nutrients     and oxygen. PTC299 is an oral investigational new drug that has been shown to decrease     production of VEGF in animal models of human cancer. In these animal models, oral PTC299     administration decreases VEGF levels in the tumor and in the bloodstream, decreases blood     vessel numbers in the tumor, and significantly slows or halts tumor growth. When given in     combination with the chemotherapeutic drug, docetaxel, PTC299 increases the antitumor     activity over use of docetaxel alone. Safety studies in research animals indicate good     tolerability at doses and drug levels that are higher than those planned for the clinical     studies. Results from Phase 1a studies in healthy volunteers indicate that PTC299 achieves     levels of PTC299 in the bloodstream that are known to be active in animal models of human     cancer. This Phase 1b study is designed to test the hypothesis that PTC299 will be tolerable     and will show evidence of anti-VEGF and antitumor activity when administered orally to     patients with cancer.   "
217985|NCT00704834|"     The purpose of this study is to test differences in RNA levels between Multiple Sclerosis     (MS) patients and normal subjects. RNA provides a message from genes altered in diseases.     We will also test DNA to determine if there are any small mutations called SNPs in any of the     genes. The last tests are two separate tests for markers of inflammation called cytokines and     eicosanoids. This research may lead to the discovery of biological markers for MS that are     useful for diagnosis and treatment.   "
217986|NCT00704847|"     The purpose of this phase III study is to Evaluate the Efficacy and Safety of Oral Salmon     Calcitonin in the Treatment of Patients with Osteoarthritis of the Knee   "
217997|NCT00705003|"     The primary objective of this study are to evaluate the synergistic effect of a combination     product, consisting of drug BCI-024 (buspirone) and drug BCI-049 (melatonin), in reducing     symptoms of depression in patients with Major Depressive Disorder.      The safety and tolerability of the combination product will also be evaluated as measured by     adverse events and vital signs.   "
218010|NCT00705198|"     The purpose of this study is to confirm the safety and efficacy of temozolomide in patients     with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy)     and relapsed malignant glioma (as monotherapy) when used in the daily medical practices.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
217987|NCT00704860|"     Reduction of volume of the hippocampus has been associated with major depression in many     studies. It has been suggested that antidepressants may protect against hippocampus volume     loss in humans associated with multiple episodes of depression and may also reverse the     reduction of volume caused by the depression. In addition, genetic markers for serotonin are     implicated with depression, and may be an indication of reduced response to antidepressant     treatments.      This study aims to enroll patients who are defined as having treatment resistant depression     (no remission after at least 2 treatments trials with an antidepressant). They will receive     an MRI scan at the initial visit and either 6 months after sustained remission or 12 months     after they enter the study for non-remitters. They will also be asked to give a blood sample     for genotyping. They will be matched by age and handedness to healthy volunteers with no     personal history of depression who will also receive an MRI scan and genotyping.      The first aim is to compare hippocampal volume of depressed subjects to healthy controls. It     is anticipated that subjects will initially have smaller hippocampal volume but of those who     sustain remission, there will be a small increase in hippocampal volume. It is also     anticipated that specific genetic markers will be related to individuals response to     antidepressant treatments.   "
217988|NCT00704886|"     BACKGROUND: Advance care planning (ACP) is the process in which patients plan for future     medical care under circumstances of impaired decision-making. Video is an underutilized     medium that can assist clinicians in discussions of future health states, such as the state     of advanced dementia. Video may enable patients to visualize the future by concisely     providing complex information vital for ACP. This study will examine whether the use of video     could facilitate a more comprehensive understanding of advanced dementia and inform     clinician-patient discussions about the level of care a patient would want in the event of     advanced dementia.      RESEARCH PLAN: We propose to conduct a randomized trial studying ACP for 200 elderly subjects     using a video depiction of a patient with dementia compared to the traditional verbal     narrative. Specific aims 1 and 2 assess the effect of a video of advanced dementia on the     clinical decision making of elderly subjects compared to the traditional verbal narrative.   "
217989|NCT00704899|"     To compare the efficacy of physiotherapy and anti-depressants in disability reduction in     patients of Fibromyalgia syndrome.   "
217990|NCT00704912|"     The goal of this three-armed randomized controlled trial is to establish the relative roles     of treatment of hyperandrogenism versus obesity (as the largest modifiable factor     contributing to insulin resistance) in treating infertility and improving pregnancy outcomes     among obese PCOS women. The investigators hypothesize that the key to restoring ovulation     leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the     key to avoiding later pregnancy complications is to improve insulin sensitivity with weight     loss.   "
217991|NCT00704925|"     A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for     treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome (LEMS). This is an expanded     access trial, which means that although data from this study will be collected and reported     to the US Food and Drug Administration (FDA)and the drug manufacturer, this is not a formal     study of drug in LEMS.      If you decide volunteer, you will be evaluated by a neurologist to determine your eligibility     to receive 3, 4-DAP by a review of your medical history, medication regimen (the medications     you are taking) and a neurological examination. If you are a female of child-bearing     potential, a serum pregnancy test will be done to ensure that you are not pregnant. Once it     is determined that this treatment is appropriate for your care, you will begin taking 3, 4     DAP by mouth in slowly increasing doses. Treatment will begin with 5mg three times a day, as     clinically needed, and if tolerated. You will be monitored for strength and side effects by     routine clinic visits at initial intervals of once a month, increasing to intervals of every     6 months as permitted. Blood will be drawn (approximately 1 tablespoon) at every clinic visit     or as often as the investigator deems necessary to assess your liver/kidney function and     blood counts. You will have an EKG (a test to see how your heart is functioning) at your     first study visit, after 6 months of taking 3,4 DAP and again every 2 years. Treatment will     be continued indefinitely if a good clinical response is achieved. This study is planned to     last indefinitely.      The dosage of 3, 4DAP is individually adjusted. The usual range is 10-15 mg 3-4 times per day     for the full effect and will increase by 50% every two weeks to 10-15 mg three to six times a     day, as needed and if tolerated. Dosages above the full effect level will not provide an     additional benefit and should not be used. 3, 4 DAP is a convulsant (causes seizures). A     total of 100 mg/day is the maximum dosage allowed.   "
217992|NCT00704938|"     RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and     stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor     cells. Vaccines made from a gene modified virus and a person's dendritic cells may help the     body build an effective immune response to kill tumor cells. Giving gene-modified lymphocytes     together with high-dose aldesleukin and vaccine therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gene-modified lymphocytes together     with high-dose aldesleukin and vaccine therapy works in treating patients with progressive or     recurrent metastatic cancer.   "
217993|NCT00704951|"     The purpose of this program is to determine the frequency of the use of Posaconazole in     immunocompromised patients refractory to first line therapy receiving therapeutic treatment     based on different pathogens in comparison to other antifungal therapy.      A further objective is to determine the frequency of the use of Posaconazole in     immunocompromised patients receiving prophylactic treatment in comparison to other antifungal     prophylaxis.   "
217994|NCT00704964|"     The objective of this study is to assess the impact of participant care and support on     treatment adherence. PegIntron pen and Rebetol will be administered to participants with     Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as     providing high vs low level of participant management based on information about the level of     participant support and management captured on the site questionnaire. Data on each     participant will be collected by a physician on an electronic participant case report form     (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed     based on the high vs low level of participant management.      The hypothesis is that Physicians investing more time and effort into participant management     achieve higher treatment completion rates among their hepatitis C patients than physicians     offering less participant management measures.   "
217995|NCT00704977|"     Purpose of this study is to evaluate efficiency and safety of Alcohol 20% for peeling     pterygium and to compare 3 different methods of operative wound closure: Bare sclera, Sliding     flap, Amniotic membrane + biological glue   "
218105|NCT00693602|"     This is a compassionate use protocol for patients with acute lymphoblastic leukemia (ALL) who     have developed hypersensitivity or intolerance to E. coli L-asparaginase and/or     PEG-L-asparaginase.   "
217998|NCT00705016|"     The purpose of this open-label, randomized, controlled, Phase 1/2 study of the integrin     inhibitor cilengitide is to evaluate the safety and efficacy of the combination of different     regimens of cilengitide added to cisplatin, 5-fluorouracil (5-FU), and cetuximab in     participants with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).      The Phase 1 part was conducted in dedicated study centers. In the Phase 2 part of this trial,     cilengitide is administered at two different doses to two experimental groups. The third     group will only receive cisplatin, 5-FU and cetuximab. In the Phase 1 part of this trial, the     dose of cilengitide in combination with cisplatin, 5-FU and cetuximab was determined.      Cilengitide is an experimental anti-cancer substance interacting with so-called integrins.     Integrins are protein molecules that are known to be present on the surface of certain cancer     cells. Integrins are also found on certain cells that belong to growing blood vessels     (endothelial cells). Integrins potentially facilitate the blood vessels' support of the tumor     (angiogenesis) as well as the tumor's growth and further spread throughout the body     (metastasis). By inhibiting integrins on the tumor cell surface, cilengitide potentially     kills cancer cells, and potentially sensitizes cancer cells to other co-administered     therapeutics. By inhibiting integrins on the endothelial cell surface, it potentially     inhibits the ingrowth of additional blood vessels towards the tumor.      Cilengitide is given as an intravenous infusion (given by a drip in one vein of your arm). If     any unacceptable side effect occurs, treatment with the study drug will be stopped.   "
217999|NCT00705042|"     The purpose of this study is to evaluate the Pharmacokinetics (PK) and safety and     tolerability of etanercept, 25 and 50 mg, administered as a single dose to healthy male     Chinese subjects.   "
218000|NCT00705055|"     The hypothesis to be tested: After the construction of a database of anthropometric     measurements, the system would extract important features of a given facial surface and be     able to match it with existing morphometric figures. A given combination of normal and     abnormal measurements will open a probable diagnosis and a list of differential diagnosis     that will be expressed as percent of matching in a descendent order to the examiner.   "
218001|NCT00705081|"     The purpose of this study is to evaluate the safety and tolerability of the low-density     lipoprotein-cholesterol (LDL-C) lowering in an Indonesian population treated with ezetimibe     co-administered with a statin in routine daily practice. In addition, the study will     investigate whether and to what extent the target levels set by the participating doctors are     achieved by the co-administration therapy.   "
218002|NCT00705094|"     For many years, researchers and doctors have studied different kinds of treatments to improve     the survival of men with testicular cancer. However, recent research has shown that many     years later, men who had testicular cancer appear to be at higher risk for developing heart     disease (heart attack or heart failure), especially if they received chemotherapy. Since     these studies were done many years after men received treatment, there was no way to know if     other factors contributed to the health problems they experienced. This study is being done     because it would be helpful to study heart function and cardiovascular disease risk factors     of men who have been diagnosed with testicular cancer, before and after they receive     chemotherapy treatment compared to men who receive treatment with surgery alone.   "
218003|NCT00705107|"     Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance     of achieving a sustained virologic response in patients with hepatitis C. The objective of     this study is to evaluate the proportion of patients who complete treatment with PegIntron     pen and Rebetol while participating in a patient assistance program. The patient assistance     program can consist of prophylactic treatment (eg, with growth factors, psychiatric     medications) or other interventions (eg, psychotherapy, patient support groups, visiting     nurse, nurse telephone calls, educational literature).   "
218004|NCT00705120|"     This protocol was a prospective, Phase I study of allogeneic bone marrow transplantation     (BMT) as the primary therapy for Osteogenesis Imperfecta Types II and III. Compatible sibling     donors and unrelated donors were stratified and analyzed according to the type of donor. All     patients with a sibling donor will received a chemotherapy conditioning regimen; a non-T cell     depleted allogeneic marrow, and GVHD prophylaxis. All patients with an unrelated donor will     receive a chemoradiotherapy conditioning regimen, a T-cell depleted allogeneic marrow, and     GVHD prophylaxis. The primary objective of this study was to investigate the safety and     toxicity of these BMT procedures in this particular population.   "
218005|NCT00705133|"     Our hypothesis is that IV or SQ Treprostinil can improve 6 minute walk distance, hemodynamics     and quality of life in patients with interstitial lung disease and severe secondary pulmonary     arterial hypertension.   "
218006|NCT00705146|"     Osteoarthritis (OA) of the thumb carpometacarpal (CMC) joint is a common condition that is     seen regularly in outpatient occupational therapy and physiotherapy departments. Prevalence     rates of symptomatic thumb OA have been found to be as high as 25%. The conservative     treatment of choice consists of splinting. There are many different types of thumb splints     available, but no specific guidelines as to which is preferred. There is limited evidence to     support the benefits of splinting.      The purpose of this study is to compare the effectiveness of two different thumb splints: the     Comfort Cool, a prefabricated neoprene splint and a custom made neoprene and thermoplastic     thumb splint. These are two of the most commonly prescribed splints in local occupational     therapy departments.   "
218007|NCT00705159|"     The objective of this study is to evaluate the safety and effectiveness of Zylet in     comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of     blepharoconjunctivitis in pediatric subjects.   "
218008|NCT00705172|"     This study is conducted in Europe. The aim of this observational study is to collect data     from children with Prader-Willi Syndrome, who have been treated off-label with Norditropin®     for more than 12 months to seek approval for Norditropin® treatment with Prader-Willi     Syndrome.   "
218009|NCT00705185|"     The purpose of this study is to develop a blood test for major depression and measure the     effects of ziprasidone monotherapy on these markers.      Specific Aim: Using a multiplex biomarker assay we will measure levels of 16 biomarkers in     patients with MDD enrolled in this ancillary study (adjunct to study NCT00555997) and compare     these results to those of healthy controls (defined as research subjects who have not met     criteria for any lifetime Axis-I disorder (DSM-IV)) from an existing dataset at PHB.   "
218011|NCT00705211|"     This study is a non-interventional (observational) study in Japan to confirm the safety and     efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs     in daily medical practice throughout a 52-week period. It is being conducted as a     post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's     guideline on Good Post-marketing Study Practice.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
218012|NCT00705224|"     Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard     treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice     in Russia. The objective of this study is to examine the influence of insulin resistance on     the safety and efficacy of treatment with pegylated interferon and ribavirin and to determine     the prevalence of insulin resistance in different populations of CHC patients.   "
218013|NCT00705237|"     This pilot study will evaluate the accuracy and ease of use of the LUMA light wire and     whether trans-illumination of the sinuses is comparable to fluoroscopy during balloon     dilation procedures.   "
218014|NCT00692380|"     Radiation therapy technology that allows increased radiation dose to the tumor while sparing     healthy tissue will improve the balance between complications and cure.   "
218064|NCT00693043|"     This study will evaluate the potential to decrease the use of IV anesthesia drugs in patients     undergoing pleuroscopy administering lidocane standardly applied to the skin in combination     with atomized lidocaine applied into the pleural cavity.   "
218016|NCT00692406|"     The broad objective of this proposal is to identify functional neuroanatomical correlates of     impairments in sustained attention during smoking abstinence. We will measure changes in     performance and regional blood oxygenation levels using fMRI while smokers and non-smokers     complete a task designed to assess sustained attention—or the continuous monitoring of     stimuli.      Our primary hypothesis is that smoking abstinence will result in impaired sustained attention     accompanied by decreases in blood-oxygenation-level-dependent (BOLD) fMRI signal in regions     associated with sustained attention including right fronto-parietal cortex, thalamus and     reticular activation system. Abstinence may also result in performance-related increases in     activation in brain regions associated with effortful processing including the anterior     cingulate cortex. We also hypothesize that smokers during the satiated state will exhibit     brain activity more similar to that of non-smokers.      In addition to task related brain responses, we will also measure changes in absolute     regional cerebral blood flow (rCBF) and hypothesize that abstinence will result in     significant decreases in regions associated with arousal (e.g., reticular activation system);     information processing (e.g., thalamus); and emotional regulation (e.g., anterior cingulate     cortex, prefrontal cortex).   "
218017|NCT00692419|"     This study is seeking to identify the most effective strategy to manage pain, sexual     dysfunction, and depression in patients receiving chronic hemodialysis therapy.   "
218018|NCT00692432|"     Introduction: In recent scientific literature, 2 proteins, macrophage migration inhibitory     factor (MIF) and high-mobility group-1 protein (HMG-1), have emerged as important mediators     of inflammation and sepsis.      Hypothesis: MIF and HMG-1 will be present in the serum of children who have undergone     cardiopulmonary bypass. MIF will be present in the myocardium of children who have undergone     cardiopulmonary bypass. The presence of MIF and HMG-1 in the serum and MIF in the myocardium     of children undergoing bypass will correlate with clinical outcome.      Methods: We will study a group of infants and children undergoing operative repair of     congenital heart disease during which there is an expectation of cardiac tissue removal.     Patients will have an assessment of cardiac function by echocardiography as well as blood     assays for tumor necrosis factor (TNF), interleukin-6, interleukin-8, interleukin-10, MIF,     and HMG-1 prior to surgery. Cardiac tissue, removed as a planned part of the procedure, will     be obtained from the cardiothoracic surgeons and assayed for MIF and for apoptosis, a     potential mechanism of myocardial dysfunction mediated by MIF and/or HMG-1. The patient will     be admitted to the cardiac intensive care unit post operatively for routine care. Blood will     be obtained at 1, 8, 24, 28, and 72 hours post operatively for the cytokine assays detailed     above. The blood will be drawn from indwelling arterial or venous catheters routinely placed     at the time of surgery. The amount of blood drawn (-4cc per sample) is unlikely to cause any     hemodynamic compromise or result in additional blood product replacement.      Sample size and Analysis Plan: 30 subjects will be enrolled to determine the presence or     absence of MIF/HMG-1 in the serum and cardiac tissue pre and post cardiopulmonary bypass.     Descriptive statistics of patient demographics and clinical outcome variables will be     correlated to serum and myocardial concentrations of the various cytokines.   "
218019|NCT00692445|"     This is a multi-center, double blind, randomized, placebo-controlled, parallel group,     flexible dose titration study conducted in centers in the USA and India. Following a washout     period, subject will be treated with citalopram 20 mg once daily for 4 weeks, then with 40 mg     once daily for 4 weeks. Subjects who tolerate 40 mg citalopram, but whose MADRS score is <     50% from baseline, but no lower than 17, will be considered partial or non-responders and     will be randomized to receive either placebo or TC-5214 as add-on therapy. TC-5214 or placebo     will be started at 2 mg daily (BID dosing), and be titrated based on tolerability and     therapeutic response up to 8 mg daily. Approximately 560 subjects will enter the Open Label     Phase and approximately 220 will enter the double blind phase of the study.   "
218020|NCT00692458|"     The purpose of this study is to test MK0822 on reducing the risk of bone metastasis in women     with breast cancer.   "
218021|NCT00692471|"     We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep     disturbances in patients with orthostatic intolerance compared with healthy control subjects.     In this pilot study, we will test the null hypothesis (Ho) that there are no differences in     the sleep quality between patients with orthostatic intolerance and healthy control subjects.   "
218022|NCT00692484|"     Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior     to surgery.   "
218023|NCT00692497|"     We want in this study to investigate the cost-effectiveness and waiting time of direct     electronic referral and booking of outpatient surgery compared to the traditional patient     pathway where the patient is seen at the outpatient clinic prior to surgery.   "
218024|NCT00692510|"     The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4,     2C8, 2B6 and UGT1A1 activity.   "
218025|NCT00692523|"     This study is a pilot, randomized trial that will examine whether the Nintendo Wii virtual     gaming system is safe and feasible for use in patients who have had a recent stroke.   "
218106|NCT00693615|"     The goals of this study are to describe the safety, reactogenicity and immunogenicity of     MEDI-517 with and without adjuvant in HPV-naïve humans. Long-term immune data is collected.      This study was originally performed by MedImmune. However, GSK is now responsible for the     clinical development of the HPV vaccine.   "
218026|NCT00692536|"     This study will compare a high-protein/low-carbohydrate diet (modified paleolithic diet, MPD)     with a diet high in slow carbohydrates (Nordic Nutrition Recommendations, NNR). The diets     will be compared with respect effects on weight reduction, metabolic regulation, and     long-term compliance to the diet regimes. Seventy-two postmenopausal overweight healthy women     have been recruited and will be followed for two years.      The following variables will be studied:        -  Anthropometry        -  DEXA        -  OGTT        -  Liver fat content measured with 1H-MRS        -  Hepatic 11β-HSD1 activity, measured with cortisone/cortisol conversion test   "
218027|NCT00692549|"     A randomized trial of the use of ultrasound by emergency physicians in the placement of     intravenous catheters in emergency patients who are found to have difficult intravenous     access (defined as two failed attempts by nursing staff).   "
218028|NCT00692562|"     The aim of this study was to evaluate the efficiency and safety of simultaneous islet-kidney     transplantation in patients of type 1 diabetes with end-stage renal disease using a     glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Islet     transplantation can result in insulin independence with excellent metabolic control when     glucocorticoid-free immunosuppression is combined with the infusion of an adequate islet     mass. Alemtuzumab (Campath-1H ®) is a 150-kDa humanized IgG1 monoclonal antibody that targets     the CD52 antigen. Prolonged lymphocyte depletion can be expected following alemtuzumab     treatment.   "
218029|NCT00692575|"     This study seeks to determine if problem-based telephone counseling improves quality of life     and emotional well-being for caregivers of persons with moderate to severe traumatic brain     injury (TBI).   "
218065|NCT00693056|"     The primary objective of this Phase IIa trial is to determine the effective doses and     treatment period for an upcoming RX-10100 Phase IIb trial in subjects with erectile     dysfunction (ED). The secondary objectives of this trial are to evaluate the safety and the     quality of life in subjects with ED receiving RX-10100 treatment.   "
218030|NCT00692588|"     Objectives:      To study the changes in brain structure and function using MRI scans in patients treated for     Alzheimer's disease.      Methods:      A pilot study of treating Alzheimer's disease with antibiotics showed some promise that this     treatment could delay the deterioration of the mind with this disease. This study is being     replicated on a larger scale, providing a more definitive answer to this question. In     addition to looking at changes of the mind (through cognitive tests), we would like to use     MRI scans in these patients before and after treatment to study the structural changes and     the chemical changes in the brain. This would provide a non-invasive look at the bran     processes that protect the brain from the effect of Alzheimer's as well as confirming that     the disease has been modified with treatment.      Impact:      The novel treatment of Alzheimer's with antibiotics has provided a potential breakthrough in     the field. In addition to verifying changes in the brain, MRI scans can observe HOW this     process could occur, thus opening doors to other new treatments for Alzheimer's and perhaps     even cures.   "
218031|NCT00692601|"     Capsiate is a non-pungent analogue of capsaicin, the component of hot peppers that makes them     hot or spicy. Unlike capsaicin, capsiate is not spicy or hot. Ingestion of capsiate has been     shown to increase resting oxygen consumption, body temperature, and the burning of fat. As     such, capsiate appears to act in a manner similar to that of many other substances that     energize us, increase our alertness and cause a rushing feeling by affecting a system in our     body that is responsible for the release of adrenaline. The major difference, however, is     that capsiate is broken down in the stomach into two components: vanilla and a fatty acid,     and is not absorbed as capsiate into the blood stream at all. This implies that the way     capsiate works is likely by acting on the cells in the gut (before it is broken down)rather     than affecting all other cells in the body as it would do if it ended up in the blood.     Therefore, the gut cells are thought to be the ones responsible for triggering the full-body     adrenaline response. In any case, the use of capsiate has been shown to be effective in     preventing weight gain and as such it may represent a possible therapy for treating obesity.     Many obesity-related programs not involving medication advocate the use of diet and/or     exercise. However, one of the biggest problems with weight loss from dieting alone is a     general decrease in our body's ability to burn the food we eat as energy. This very problem     is the reason for why people turn to adrenaline-releasing drugs like caffeine and ephedra.     Unfortunately though, if too much is consumed, there is a high risk of bad side-effects.     However, low dose caffeine/ephedra compounds (that are within specified FDA limits) have     recently been reported to be effective. Moreover, these compounds are used with great     frequency by people attempting to lose weight.      Given that capsiate increases body temperature, promotes the burning of body fat and has an     exceptionally great side-effect profile, it looks to be a very effective supplement for use     in treatment of obesity and overweight. As such, it would be important to test this     supplement along with exercise. This is because consuming capsiate with exercise may enhance     its effectiveness in increasing the burning of body fat. The primary purpose of this study is     to examine the response of young healthy males to a 90 minute bout of moderate intensity     cycling after having consumed 0 mg, 3 mg, or 10 mg of capsiate.   "
218032|NCT00692614|"     This study will evaluate the treatment effect of three doses of the I-vation TA implant     (MK0140) in diabetic patients with clinically significant macular edema.   "
218033|NCT00692627|"     acidosis, acute renal failure and acute pulmonary oedema are common, and frequently fatal,     manifestations of severe P. falciparum malaria. The course of all three might be ameliorated     by optimising a patient's intravenous fluid therapy. The fluid treatment of severe malaria is     presently empirical, by defining cardiovascular responses to volume replacement we would     provide a physiological basis for resuscitation strategies.      We will use pulse contour cardiac output monitoring (PiCCOTM) to guide the fluid     resuscitation of patients admitted to intensive care with severe malaria. With data collected     during the patients' admission we hope to:        1. Assess the degree of hypovolaemia in adults with severe malaria and its contribution to          microcirculatory dysfunction and acidosis.        2. To assess the relationships between volume status, haemodynamic parameters and the renal          and pulmonary manifestations of severe malaria.        3. To assess the utility of central venous pressure measurement as a guide for fluid          administration in patients with severe malaria        4. To investigate the prognostic and clinical utility of central venous oxygen saturation          in severe malaria      In this way we hope to develop a greater understanding of the pathophysiology of haemodynamic     derangement in severe malaria. By comparing the PiCCO derived data with simpler clinical     parameters, we hope to determine potential fluid resuscitation strategies - relevant for a     resource poor setting - whose efficacy could be confirmed in future trials.   "
218044|NCT00692783|"     C. dubliniensis has been identified as pathogen in Oropharyngeal Candidiasis(OPC)particularly     among HIV patients. Azole therapy is a cornerstone in OPC, but resistance within C.     dubliniensis isolates to diflucan is common.This is a prospective collection of biological     specimens from oropharyngeal cavity with the purpose of determining the prevalence of C.     dubliniensis in HIV/AIDS patients at the Duval County Department of Health Comprehensive care     Center. It is hereto proposed an estimation of azole-resistance in these isolates.   "
218034|NCT00692640|"     The purpose of this study is to evaluate the safety and tolerability of XL147 in combination     with erlotinib (Tarceva®) in subjects with solid tumors. XL147 is a new chemical entity that     inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce     apoptosis (programmed cell death) in tumor cells. Erlotinib is an orally administered     inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a     single agent for the treatment of patients with locally advanced or metastatic non-small-cell     lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in     combination with gemcitabine for first line treatment of patients with locally advanced,     unresectable or metastatic pancreatic cancer.   "
218035|NCT00692653|"     The purpose of this study is to determine whether or not participation in an experimental     program called the P4 program is useful to men who are faced with choices about treatment     for their early stage prostate cancer. The P4 program consists of a series of questions and     information for the participant.      Before seeing the cancer specialist, participants will answer several questionnaires on a     computer. This will take about 20-30 minutes. Participants may choose to do this on a     computer at home or on a touch-screen computer in the clinic. Half the participants will then     be shown several highly rated informational websites about prostate cancer treatments. The     other half, based on the individual participant's answers, will receive the P4 program's     customized written and on-screen information. Reading the information and watching videos     will take about 20 minutes.      About one month later, and again 6 months, participants will complete follow-up     questionnaires electronically or by mail. These questionnaires will help us understand how     each participant's decision for treatment of their prostate cancer went. Answering these     questionnaires should take about 20 minutes each time.   "
218063|NCT00693030|"     Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the     use of overlapping drug-eluting stents. Whether the substantial impairment of arterial     healing observed at sites of overlap in preclinical pathologic studies persists in patients     undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels     requiring stents in overlap are prospectively randomized to receive multiple     sirolimus-,paclitaxel polymer-or zotarolimus eluting stents versus bare metal stents. The     completeness of stent struts coverage and/or late malapposition are evaluated by Optical     Coherence Tomography at 6 months follow-up   "
218036|NCT00692666|"     Letigen® was a combination drug containing ephedrine, an adrenergic agonist with lipolytic     and appetite-inhibiting properties. The drug was used as adjuvant treatment of obesity from     1990 and up to 2002 when it was withdrawn from the market by the manufacturer. The basis for     this was a number of spontaneous reports about patients that died during treatment with     Letigen®.      The causal relation has never been addressed. There are only sparse data from randomised     studies and the above-mentioned reports are not conclusive.      We propose a controlled study based on data from Statistics Denmark that hold a complete copy     of the Prescription Register of the Danish Medicines Agency and the Danish Hospital Discharge     Register. The aim of the study would be to determine whether there is an excess frequency of     deaths and serious cardiovascular events that can not be explained by particular     characteristics of users of the drug. A well-known problem in such observational studies is a     fundamental incomparability between users and non-users of drugs. In the present setting, it     should be expected that use of Letigen® is associated with high BMI, smoking, alcohol abuse,     type-2 diabetes, mild hypertension, low physical activity and other indicators of unhealthy     lifestyle. Thus, an uncritical comparison between users and non-users of Letigen® regarding     serious cardiovascular events will probably show an excess frequency that can not necessarily     be attributed to the drug. This problem can be addressed by a special epidemiological     technique - the case-crossover design - which is particularly robust to such comparability     problems. In brief, only cases should be included. Controls are the same persons at an     earlier time, , where the case-defining disease has not yet developed. The exposure of cases     will be compared with the exposure of the same persons' case history.      To account for the effect of chronic exposure, we also perform, as a secondary analysis, a     conventional case-control study nested within the cohort of Letigen users, and employing a     risk-set sampling technique.   "
218037|NCT00692692|"     We propose to evaluate the question of whether there is a significant difference between the     traditional method of serratus flap tissue expander reconstruction and the acellular matrix     method.   "
218038|NCT00692705|"     The study is carried out in order to investigate if [11C]AZD2995, compared to [11C]AZD2184,     is a more suitable PET ligand for in vivo imaging of β amyloid depositions in the human     brain. In the study the two PET ligands will be examined in both healthy volunteers and     patients with Alzheimer's Disease.   "
218039|NCT00692718|"     Our study is to investigate the effect of N-3 Fatty Acids for the prevention of atrial     fibrillation in patients with acute heart failure or acute myocardial infarction   "
218040|NCT00692731|"     The primary objective of this trial is to evaluate the influence of consuming a tea catechin     containing sports beverage on body fat mass during exercise-induced weight loss among     overweight and obese men and women.   "
218041|NCT00692744|"     In all the Western populations, the annual incidence of subarachnoid hemorrhage (SAH)     increase with age. In patients older than 70 years, the occurrence of SAH exposes them to     high risk of morbidity and a poor quality of life.      In this age bracket, the single randomized which compared endovascular coiling to     microsurgical clipping (ISAT Study) showed that the relative risk of morbidity increased     after coiling. Moreover, some prospectives studies about endovascular coiling described     favorable outcome in 48% to 63% of patients, complete occlusion in 51% to 69% and a     procedural complication rate in 13% to 19%. From prospectives series, the proportion of     favorable outcome after microsurgical clipping was estimated around 66% but the procedural     complications are few reported. The outcome for patients treated conservatively was     catastrophic. Lastly, the hydrocephalus in this age class is common, occurring in 55% of     patients.      The study hypothesis is that, in this age class, no difference exists between the 2     obliteration procedures.      An accurate evaluation of result in term of functional disability, quality of life and     prognosis predictive factors seems a judicious question.   "
218042|NCT00692757|"     The purpose of this study is to determine whether hypochlorous acid is an effective     antiseptic agent to prevent surgical site infection.   "
218043|NCT00692770|"     To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of     Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or     local ablation).   "
218091|NCT00693420|"     This study evaluates the safety and effectiveness of topical bimatoprost solution for     enhancing eyelash prominence.   "
218255|NCT00709267|"     The purpose of the study is to determine the bioavailability of orally administered folic     acid compared with the i.v. administered folic acid, and to use the samples collected to     validate the analytical methods for estimation of folic acid in plasma and red blood cells     (RBCs).   "
218045|NCT00692796|"     The purpose of this study is to determine the effects of Pulmonary Rehabilitation (PR) on     shortness of breath, exercise capacity, symptom control, mental health, cognitive function,     and quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). Pulmonary     rehabilitation has already been shown to benefit patients with other chronic respiratory     diseases, such as chronic obstructive pulmonary disease (COPD). We believe that pulmonary     rehabilitation will benefit patients with IPF as well.   "
218046|NCT00692809|"     HIV induced altered representation and function of regulatory T cell subsets (NKT and Treg     cells) impair the protective T cell response against M.tuberculosis and disrupts LTBI, thus     facilitates faster progression and development of severe forms of clinical TB in HIV-TB     co-infection.   "
218047|NCT00692822|"     To perform a laboratory sensitivity testing survey of antibiotic agents against Neisseria     gonorrhea isolates from men with symptomatic urethritis seen at an STD clinic.   "
218048|NCT00692835|"     Protocol Synopsis        -  Protocol title: Immediate postoperative course of patients with mini Video Assisted          Thyroidectomy (miVAT) versus classic Thyroidectomy (cTT)        -  Purpose: Comparison of the immediate postoperative course and complications of the          patients using the two techniques        -  Design: Prospective, single-center randomized study        -  Patient Population: Male or female subjects 18 years of age or older with nodular goiter          who are scheduled for total thyroidectomy (miVAT or T)        -  No. of Subjects: 100 patients divided into two groups, estimated up to 1 year to enroll        -  Duration of Treatment: During the operation        -  Duration of Follow-up: Follow-up will be performed daily while hospitalized, and by          phone till the 7th postoperative day        -  Endpoints: To evaluate the safety and cost-effectiveness of each technique   "
218049|NCT00692848|"     Serious bacterial infections are often difficult to detect in children with fever without     source. Procalcitonin is a better blood marker of infection than White blood cell count and     possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription.     Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in     children 1 to 36 month old with fever without source and our hypothesis is that it will lower     the antibiotic prescription rate   "
218050|NCT00692861|"     This study, done in collaboration with Cornell University in New York, will explore the     potential role of the body s immune response to gluten in ataxia. Celiac disease is an     autoimmune disorder that is triggered by the ingestion of wheat gluten and related proteins     in genetically susceptible individuals. Some people with celiac disease also develop ataxia,     which is a loss of muscle coordination, leading to imbalance. The cause of the associated     ataxia is not well understood, but it is suspected to be related to the immune response     towards gluten in these patients. Preliminary results indicate that antibodies in people with     celiac disease can react with brain proteins, which might have a role in the associated     neurologic deficits. The aim of this study is to characterize the immune response in the     ataxia that is associated with celiac disease.      People 18 years of age and older with 1) ataxia and no celiac disease, 2) ataxia plus celiac     disease and 3) matched healthy control subjects will be enrolled at the NIH. People with     celiac disease only will be enrolled at Cornell University.      All participants have a blood sample drawn for various tests of immune function as well as     genetic tests. Healthy volunteers also have a history and physical examination if they have     not had one done at NIH in the past year. Some patients may require additional clinical     evaluations for clinical or diagnostic reasons.   "
218051|NCT00692874|"     This is an open label, non-interventional quality of life analysis for Zoladex treated     prostate cancer patients by investigator's questionnaire   "
218052|NCT00692887|"     Study come to investigate the correlation between visual fields (VF) defects map generated by     preferential hyperacuity perimeter (PHP) and features of the choroidal neovascular lesions     (CNV) demonstrated by Optical Coherence Tomography(OCT).      To investigate the Foresee PHP ability to asses treatment progression post treatment.   "
218053|NCT00692900|"     The purpose of this study is to determine the safest and maximum tolerated dosing regimens     for intraperitoneal oxaliplatin with intravenous docetaxel and intravenous oxaliplatin with     intraperitoneal docetaxel for recurrent ovarian, primary peritoneal, or fallopian tube     cancer.   "
218054|NCT00692913|"     A study designed to see if the study drug will increase blood levels of vitamin D, bone     mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of     falls as compared to women receiving standard care for osteoporosis.   "
218055|NCT00692926|"     The main purpose of this investigational (not approved by the FDA) Phase I research is to     test whether transplantation of umbilical cord blood cells can be safely supplemented with a     transfusion of a portion of these cells that have been sorted (collected from a special     machine called a cell sorter) and then either infused a few hours after the standard     transplant or for some patients grown in a special system in the laboratory prior to the     transplant, designed to increase the number of stem cells transplanted. This system is     currently in the early phases of testing.   "
218056|NCT00692939|"     The objective of this study is to evaluate the safety and effectiveness of administering     high-dose chemotherapy followed by infusion of autologous CD34-selected peripheral blood stem     cells (PBSC) in pediatric and young adult patients with severe Crohn's disease.   "
218057|NCT00692952|"     A multicentric clinical trial in three Chinese Maternal and Child Hospitals was conducted to     evaluate the efficacy, safety and acceptability of newly-developed vaginal contraceptive gel,     the optimized benzalkonium chloride (BZK) gel containing 18mg BZK, with comparison to a     currently marketed (in China)contraceptive gel LELEMI® containing 50mg Nonoxynol-9 (N-9).   "
218058|NCT00692965|"     The purpose of our study is to survey the quality of sleep and sleep disordered breathing in     a HIV infected inner city ambulatory African-American Population aged 50 years and older.      Hypothesis: African-American HIV infected individuals aged 50 years and older have a high     prevalence of sleep disorders and lower quality of sleep.   "
218107|NCT00693628|"     We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly     than control subjects who wear no shrinkers. We also expect them to experience greater     reduction in residual limb volume during the early stages of postoperative care leading up to     prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting,     increased time to the first prosthetic socket replacement, and fewer socket replacements by     the end of the transition to stable phase.   "
218059|NCT00692978|"     Asthma is most effectively treated by delivering inhaled drugs from an inhaler (puffer)     directly into the lungs. Inhaled steroids are used in asthmatic patients to dampen down lung     inflammation, which unchecked, can often lead to patient symptoms. Inhalers deliver a mist     containing particles of lots of different sizes (like hairsprays). Medical puffers used by     patients produce a 'coarse' mist of drug particles, which have the potential for side     effects, as different sized particles will reach different parts of the airways and include;     the mouth, the throat, the windpipe, and the bloodstream (all places we do not want the     inhaled drug to go − and can give rise to important side effects)and, the lungs (where we do     want the drug to 'deposit').      Our aim in this study is to test an inhaled steroid by giving it to subjects as a 'fine' mist     containing drug particles of nearly all one size using a research nebuliser (a Spinning Top     Aerosol Generator). We shall use small, intermediate and large drug particle mists. We aim to     find out how much of the drug goes to the blood stream for each particle mist and compare it     with the standard puffers used in routine clinical practice.      We hope this study will provide information to the rationale that by improving the efficiency     of drug delivery (by changing drug particle size) one may improve inhaled drug delivery and     ultimately, clinical patient benefit.      Healthy volunteers and asthmatic patients will be recruited at the Royal Brompton Hospital     London. The study is funded by GlaxoSmithKline, Research & Development, U.K.   "
218060|NCT00692991|"     Coronary artery disease (CAD) is caused by a narrowing of the blood vessels that supply blood     and oxygen to the heart. Balloon angioplasty and stent placement are two treatment options     for people with reduced heart function caused by CAD. This study will use magnetic resonance     imaging (MRI) procedures to evaluate heart function over time in people with CAD who have     undergone a balloon angioplasty or stent placement procedure.   "
218061|NCT00693004|"     A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 monotherapy in     subjects with Alzheimer's disease. The study consists of a 3-month double-blind treatment     period and an optional 3-month extension period.   "
218062|NCT00693017|"     This study is intended to provide evidence that zonisamide is safe and effective in the     treatment of myoclonic seizures. The total planned trial duration will be 6.5 months. After     that, subjects who have completed the study will be eligible to enroll in an open-label     extension study until zonisamide is marketed for this indication or further development in     this indication stops. This extension study will be described in a separate protocol     (E2090-E044-318).   "
221915|NCT00757822|"     This study will compare two different drug regimens (oral dronabinol versus intravenous     ondanseteron) for the prevention of post-operative nausea and vomiting (PONV).   "
218066|NCT00693069|"     Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces     peri-procedural and long-term ischemic complications. Documented reduced response to     clopidogrel has been associated with subsequent major adverse cardiovascular events.     Strategies to optimize platelet inhibition pre-PCI are under investigation.      This study sought to evaluate the effect on platelet aggregation of four different dosing     regimens of clopidogrel given before elective PCI.   "
218067|NCT00693082|"     The overall aim of this study is to explore the effects of flaxseed supplementation and     determine whether it is a feasible and potentially effective dietary intervention among women     with polycystic ovarian syndrome (PCOS). Women, ages 18-45, with clinically confirmed PCOS     (N=20) will be scheduled for baseline measures and then instructed and given supplies     necessary to follow a flaxseed supplemented (30 g/day) diet for a period of three months,     whereupon follow-up measures will be taken. Subjects will be asked to resume their typical     (unsupplemented) diet for another three months and a second set of follow-up measures will be     taken. Baseline levels of bioavailable and total testosterone, fasting insulin, glucose, and     triglycerides (TG), total/LDL/HDL cholesterol, body weight, degree of hirsutism and acne, and     menstrual cyclicity will be compared to levels at 3 and 6 month follow-up. The overall     hypothesis (based upon our work in men at risk for prostate cancer and data from one     case-study conducted in a woman with confirmed PCOS) is that during the time women receive     flaxseed supplementation they will experience reduced serum levels of testosterone, and total     and LDL cholesterol, as well as clinical evidence of hirsutism. Given the pilot nature of     this study, statistical analyses will be limited to simple descriptive statistics. We have     observed no negative side effects, other than minor gastro-intestinal occurrences (i.e.,     temporary increased flatulence, borborygmi, increased number of stools, etc.) associated with     flaxseed supplementation in our previous studies either with short or long-term use. Flaxseed     supplementation will be discontinued if indicated and the events reported to the     institutional review board.   "
218068|NCT00693095|"     The purpose of this research study is to learn if your own immune cells can be activated and     multiplied in order to help your body fight off the tumor cells in your brain. The safety of     this procedure will also be studied. This procedure, called CMV-autologous lymphocyte     transfer or CMV-ALT is investigational which means that it is not approved by the US Food and     Drug Administration (FDA) and is still being tested in research studies. Autologous     lymphocyte transfer or ALT means that you will receive your own immune cells back (and not     from another donor) as a treatment after they have been activated and grown to large numbers     in a clinical lab.      It is believed that the body's immune (protection) system can attack tumor cells and kill     them. Immune cells called T-lymphocytes (T-cells) can recognize special proteins on the     surface of tumors as a signal to attack and fight the cancer. In most patients with advanced     cancer, the immune system does not adequately destroy the tumor because the white blood cells     or T-cells are not stimulated enough.      Before your T-cells can become active against tumor cells, they require strong stimulation.     There are special stimulator cells in the body called Dendritic Cells (DCs) that can take     up proteins released from cancer cells and present pieces of these proteins to T lymphocytes     to create this strong stimulation. Dendritic cells taken from your blood will be pulsed or     loaded with genetic material called RNA (ribonucleic acid), which stimulates the DC to change     the RNA into a protein called pp65. This protein is produced by a common virus called     Cytomegalovirus (CMV) that 70-80% of us have been exposed to in our lifetime. Recently, we     have found that this virus is present in many malignant brain tumors. Brain tumors are very     aggressive and, for reasons we do not yet understand, are difficult for the body to attack.     The CMV virus is a target in the tumor that, if attacked by your immune systems cells, may     prevent your tumor from growing. We have found that we can grow immune cells to very large     numbers from the blood of people who have evidence of prior exposure to this virus. You will     therefore be tested to determine if you have pre-existing antibodies to this virus in order     to participate in this study.      We will use your DCs to activate and grow immune cells from your blood to large numbers in a     clinical laboratory. These CMV-specific immune cells, called CMV-ALT, will be returned to     your body when they have become activated. It is hoped that these cells will seek out and     kill tumor cells that express the CMV viral protein and not attack normal cells. The transfer     of immune cells that stimulates your immune system is called adoptive immunotherapy. We will     evaluate two doses of immune cells in this study (Dose 1 and Dose 2). Depending on when you     are enrolled in this study you will receive either Dose 1 or 2. The first six patients     enrolled on this study will receive Dose 1 (the lower dose) and the next six patients will     receive Dose 2 (the higher dose). We do not know at this time if either dose is more     effective or safer to administer which is why we are testing both doses. Dose 2 will be a     larger number of immune cells if the treatment is found to be safe in the first six patients     treated during this study.      In this study we will also see, in some randomly selected patients, if giving an injection of     the DC pulsed with pp65 RNA into the skin improves the function of the CMV-ALT treatment or     not. You will receive three injections under the skin of either some of the same DC that were     used to stimulate your immune cells in the clinical laboratory or three injections of saline     (salt solution) under the skin starting with the infusion of the CMV-ALT. It is unknown if a     DC injection will be beneficial to the immune cells or not so the responses will be compared     in patients who receive DC versus saline injection with their CMV-ALT. After these three     injections, blood will be collected to compare the responses between patients that received     saline to those that received DC injections.   "
218069|NCT00693108|"     it has been shown that androgens in non human primates may favour follicular growth in the     ovaries when animals are treated with gonadotropins which are the hormones used in patients     receiving treatment with in vitro fertilization. Therefore, this study investigates the     potential usefulness of testosterone treatment preceding gonadotropin administration in in     vitro fertilization patients having a previous poor response to gonadotropins alone.   "
218070|NCT00693121|"     Patients with traumatic brain injury often experience a period of acute confusion that may     include agitation as they recover from their injuries. While this confusion generally     resolves with time, patients may pose increased risk of injury to themselves or others during     this period. Their behavior may also increase stress for family members and interfere with     their ability to benefit from rehabilitation therapies. A number of different medications     have been used to treat confusion to decrease agitation, decrease risk of injury, and improve     participation in rehabilitation therapies. To this point, there has not been a research or     scientific basis for knowing which medication is the best for a specific patient. The overall     goal of this study is to conduct a scientific investigation to help determine which     medication works best to treat confusion.      Study hypothesis: Amantadine will reduce the severity and number of symptoms of acute     confusion after traumatic brain injury.   "
218108|NCT00693641|"     The purpose of the study is to investigate the effectiveness of a sun lotion containing a     specific Jellyfish sting inhibitor versus regular sun lotions as controls. In addition, to     investigate the effectiveness of hot/cold immersion for the treatment of Cyanea sp stings     versus local pain relief with prescription free pharmaceutical drug (Xylocain 30 mg/ml (3%)     lidocain).   "
218071|NCT00693134|"     Children can have or develop certain problems with their heart function, specifically with     the heart muscle or myocardium. This problem can be caused by many things specifically by     infection resulting in myocarditis (inflammation of the heart muscle) or dilated     cardiomyopathy (caused by many factors including high blood pressure and heart attacks). The     body goes through many processes to repair the injured tissue including using proteins that     cause the muscle mass to increase called matrix metalloproteinases (MMPs). The body also uses     proteins that direct the MMPs to stop increasing the muscle mass called tissue inhibitory of     metalloproteinases (TIMPs). Currently, there are no published studies that explain or     evaluate the relationship that MMPs and TIMPs have in myocarditis and dilated cardiomyopathy     in children.      The investigator wishes to perform a prospective study of the serum levels of these proteins     and their regulators in children with myocarditis and/or dilated cardiomyopathy and compare     them with children that have no heart disease.   "
218072|NCT00693147|"     Protocol Synopsis        -  Protocol title: Late postoperative course of patients with mini Video Assisted          Thyroidectomy (miVAT) versus classic Thyroidectomy (T)        -  Purpose: Comparison of the late postoperative course and complications of the patients          using the two techniques        -  Design: Prospective, single-center randomized study        -  Patient Population: Male or female subjects 18 years of age or older with nodular goiter          who are scheduled for total thyroidectomy (miVAT or T)        -  No. of Subjects: 100 patients divided into two groups, estimated up to 1 year to enroll        -  Duration of Treatment: During the operation        -  Duration of Follow-up: Follow-up will be performed by evaluation at the 3rd and 6th          postoperative month ±5 days        -  Endpoints: To evaluate the long term safety of each technique   "
218073|NCT00693160|"     This research study is being done because pain is a significant problem for patients with a     variety of medical problems and following surgery or traumatic injury. Currently available     pain medications may not treat all types of pain or may treat pain only at doses that produce     side effects and complications. The medication in this study may have a role in better     treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic,     pain reliever), given into the fluid in the back near the spine has any effect on pain or     discomfort in the skin sensation that will take place after applying capsaicin (chili pepper)     cream. The sunburn-like sensation that people experience after having capsaicin cream applied     is similar to, but much milder than, the pain that some people have after surgery and after     certain types of nerve injuries. This study will test the effects of combining two     medications that are often given together to control postoperative pain or pain from a nerve     injury. The investigators are especially interested in answering two questions about the     effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous [IV] narcotic     painkiller):        1. How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on          your skin, which develops after applying capsaicin cream?        2. What pain relieving effects does spinal ketorolac have when given with IV remifentanil?   "
218074|NCT00693173|"     The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with     identical radiation treatment technique and parameters. After the two setups have been     planned, the treating faculty reviews the setups and will choose the setup he feels that will     give the patient improved dosimetry to the local regions and hopefully reduce toxicity and     improve treatment tolerability.   "
218075|NCT00693186|"     Primary objective:        -  To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA          during the first two years of life the percentage of subjects with an anti-HBs antibody          titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10          µg .      Secondary objectives:        -  Additional immunogenicity assessments        -  Standard safety assessment.   "
218076|NCT00693199|"     The aim of this study was to investigate the efficacy and safety of low dose amlodipine     alone, or combined with low dose terazosin in male patients with both lower urinary tract     symptoms and hypertension.   "
218077|NCT00693212|"     The first phase was a double-blind crossover design of methylphenidate in the treatment of     adult ADHD. The second phase consisted of an open-label extension trial of methylphenidate in     adult ADHD. It was hypothesized that methylphenidate would prove more effective than placebo     in treating ADHD symptoms during the first phase. It was also hypothesized that     methylphenidate responders from the double-blind trial would continue to benefit from     treatment in the second phase. Improvement would include both ADHD symptoms and social     adjustment.   "
218078|NCT00693225|"     The purpose of this study was to determine the effect of morning versus bedtime     administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients     with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of     Zegerid would be superior in healing esophagitis compared to morning administration prior to     a meal.   "
218079|NCT00693238|"     The purpose of this trial is to give a shorter course (5 ½ weeks) of radiation that has as     little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks)     of radiation, without decreasing the chance of killing prostate cancer cells.   "
218080|NCT00693251|"     It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.   "
218081|NCT00693264|"     The purpose of the study is to learn about an herbal product called Hoodia gordonii. We want     to know if Hoodia gordonii affects blood pressure, heart rate (pulse), heart pressures, and     the heart's electrical conduction system. To participate in this study you must be a healthy     volunteer with no known medical problems.   "
218092|NCT00693433|"     This phase I trial is studying the side effects and best dose of temsirolimus when given     together with dexamethasone in treating patients with recurrent or refractory multiple     myeloma. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving temsirolimus together with dexamethasone may kill more cancer cells.   "
218109|NCT00693654|"     The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in     the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled     comparative trial.   "
218082|NCT00693277|"     1. Research question Can a web-based nutritional educational intervention improve          phosphorus knowledge and control of phosphorus intake?        2. Experimental design           Following enrollment and informed consent, subjects will be randomized to one of two          arms (group1: usual care; group 2: usual care plus Internet-based nutrition module). All          subjects will undergo baseline data collection, consisting of:             1. Short form of the test of functional health literacy in adults: categorizes               individuals as having adequate, marginal or inadequate health literacy.             2. Chronic Kidney Disease (CKD) Knowledge Assessment Tool: addresses nutritional               knowledge of CKD.             3. SF-12 Health Survey version 2: a 12-item measure of health related quality of life.             4. Kidney Disease Self-Management Survey: a 58-item Likert scale based on theories               important for self-management in chronic disease.             5. 3-Day Dietary Diaries             6. Lab work:           i. Serum phosphorus, calcium and parathyroid hormone levels. ii. Circulating endothelial          cells, a novel marker for vascular damage.           Following baseline data collection, group 1 will continue with their scheduled clinic          visit, while group 2 will spend approximately 30 minutes completing a web-based          nutrition module. After completion of the module, patients will proceed with their          scheduled clinic visit.           All subjects will then be asked to return in 30-60 days to repeat some of the survey          information and blood work        3. Major risks to subjects There is the potential for some mild discomfort from the          necessary blood draws, which occur twice per subjects.        4. Potential benefits to subjects Subjects randomized to the web-based module may receive          an educational benefit from it.        5. Consent procedures Only individuals who can provide their own consent can participate.          Upon agreeing to enroll, a study coordinator or investigator will provide the subject          with a copy of the consent form, and will remain available to answer any questions.   "
218083|NCT00693290|"     Study hypothesis The overall aim of this study is to compare two bowel preparations that are     used prior to a colonoscopy procedure.      The principal research questions are:        1. Does the use of a low residue diet increase patient concordance to the bowel preparation          instructions?        2. Does the use of a low residue diet decrease the adequacy of assessment of the mucosa?        3. Does the use of a low residue diet increase the willingness of patients to undertake          repeated examination as is required for disease follow−up?        4. Does body weight affect perceived tolerability of either group?   "
218084|NCT00693303|"     The purpose of this study was to examine the changes in handwriting performance in elementary     aged children who received handwriting training which included use of the My Scrivener     stylus. Training on the My Scrivener stylus provided additional feedback to the children     which is hypothesized to produce significant improvement.   "
218085|NCT00693316|"     The purpose of this study is to evaluate the safety and tolerability of escalating doses of     ORM-12741 in healthy volunteers.   "
218086|NCT00693329|"     This is a multi-center clinical study designed to assess the performance of the Triage NGAL     test as an aid in the early risk assessment for contrast-induced nephropathy (CIN).     Approximately 260 adults at risk for CIN undergoing intra-arterial angiography involving     administration of iodinated contrast agent(s) will be enrolled.   "
218087|NCT00693342|"     RATIONALE: Vaccines made from tumor antigens may help the body build an effective immune     response to kill tumor cells. Biological therapies, such as OPT-821, may stimulate the immune     system in different ways and stop tumor cells from growing. Giving vaccine therapy together     with OPT-821 may kill more tumor cells. It is not yet known whether giving vaccine therapy     together with OPT-821 is more effective than OPT-821 alone in treating ovarian epithelial     cancer, fallopian tube cancer, or primary peritoneal cancer.      PURPOSE: This randomized phase III trial is studying vaccine therapy and OPT-821 to see how     well they work compared with OPT-821 alone in treating patients with ovarian epithelial     cancer, fallopian tube cancer, or primary peritoneal cancer in complete remission.   "
218127|NCT00693901|"     Engaging in physical activity is an important health behavior for maintaining good health and     preventing disease. Public parks offer community members readily accessible areas for     recreation and exercise. Modifying park programs and facilities to meet the specific needs of     community members may encourage people to engage in more physical activity. Furthermore,     using feedback from the community might be the best way to determine how park funds should be     allocated for modifications. This study will compare two approaches to park programming and     will determine which approach is best at increasing physical activity within the community.   "
218088|NCT00693355|"     Short chain fatty acids (mainly acetate, propionate and butyrate) are produced in the large     intestine by bacterial fermentation of unabsorbed carbohydrates, such as dietary fibers.     Mainly butyrate is an important energy source of the mucosa and has a pivotal role in the     regulation of mucosal proliferation, immune function and mucosal protection.      High fiber diets increase the concentrations of colonic butyrate, what has often been     proposed as one of its protective mechanisms. Furthermore, butyrate enemas have been proved     effective in the treatment of ulcerative colitis. In the present study the direct effects of     butyrate on the distal colon will be studied in 30 healthy volunteers using rectal enemas.     The study has been divided into two parts, each part studying different parameters, which     interfere when measured synchronously and, therefore, need to be studied separately.      A. The effects of butyrate enemas on colonic permeability (n=15) B. The effects of butyrate     enemas on parameters of colonic defense, integrity and inflammation (n=15) The effects of     butyrate will be studied in a healthy and in a stressed colon. This way the protective     effects of butyrate on intestinal stress can be studied. Prior to the main study, two small     pilot studies will be carried out. In the first pilot study the retrograde spread of a rectal     enema will investigated (n=2). In the second pilot study the dose and the type of a suitable     stressor that will induce reversible damage to intestinal mucosa will be determined (n=12).   "
218089|NCT00693381|"     Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and     steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12     weeks it was stopped. For the others MMF remained at initial dose.   "
218090|NCT00693407|"     Visceral hypersensitivity as evidence of central sensory sensitization is evident in many     patients with functional disorders such as functional dyspepsia (FD) and irritable bowel     syndrome (IBS). We recently demonstrated both somatic hypersensitivity and abnormal     endogenous pain modulation in IBS, both of which indicate central sensitization as a crucial     mechanism in IBS. Endogenous pain mechanisms regulate, fine-tune and integrate sensory and     homeostatic, including neuroendocrine, immune, motor and autonomic nervous system processes.     Hitherto, no studies have investigated the role endogenous pain modulation in FD. Abnormal     modulation could explain several of the symptom complexes associated with FD and provide a     rationale for exploration of new treatments.      The current study was designed to        1. investigate the gastric sensitivity in FD patients and healthy controls during gastric          capsaicin stimulation        2. assess the endogenous pain inhibitory modulation system in FD patients and healthy          controls during heterotopic stimulation   "
218093|NCT00693446|"     Experience with tacrolimus in pancreas transplantation has become a standard for     immunosuppression in almost all pancreas centers over the world. Several centers have shown     very good results in simultaneous pancreas-kidney (SPK) transplant recipients receiving     antithymocyte globulin induction and maintenance immunosuppression consisting of calcineurin     inhibitor and mycophenolate mofetil with or without corticosteroids.      The use of sirolimus in SPK transplant patients has for the moment only been studied, with     good results, in association with tacrolimus or cyclospsorine (CsA). In renal     transplantation, there is also evidence that sirolimus (Rapamune) is a potent     immunosuppressant that significantly reduces the incidence of acute rejection when given with     CsA, effective as base therapy in the post-induction period. Because of Rapamune's     effectiveness and different safety profile, it might be advantageous in terms of reduced     nephrotoxicity to avoid completely calcineurin inhibitors without increased incidence of     acute rejection.      To explore this further, the following study is designed to assess the use of SRL versus TAC,     both treatment groups including rATG plus MMF and a 3-month course of steroids in de novo     simultaneous pancreas-kidney transplant recipients.   "
218094|NCT00693459|"     The purpose of this research study is to test the effectiveness of a new anoscope used while     performing a traditional hemorrhoidectomy.   "
218095|NCT00693472|"     This study is designed to evaluate the effectiveness of preladenant in the prevention (Part     1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute     psychosis using the Barnes Akathisia Scale.   "
218096|NCT00693485|"     A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and     effects on visual function of brimonidine intravitreal implant in patients with glaucomatous     optic neuropathy. Patients will be followed for up to 1 year.   "
218097|NCT00693498|"     Background: Children having open heart surgery to repair congenital heart defects demonstrate     a large inflammatory response to the heart-lung machine and to surgery itself. In general,     the more intense their inflammatory response, the more critically ill they are following     surgery. These children routinely require large numbers of blood transfusions during and     following surgery as part of their medical management that adds to their heightened     inflammatory state. Whether additional steps to wash blood products and remove the     substances contributing to post-transfusion inflammation will limit this response, and     improve the health of children following open heart surgery, remains to be studied.      Aims: To compare the inflammatory response in children having open heart surgery who receive     washed versus unwashed blood transfusions.      Methods: We will randomly assign children having open heart surgery to one of two groups:     group 1 will receive blood transfusions per the current standard of care, group 2 will     receive blood transfusions that have been washed in addition to the current standard of care.     We will then use blood tests to measure the inflammatory response in children of each group.     We will compare the results to determine whether washing blood transfusions decreases     inflammation and post-operative complications following open heart surgery.      Conclusion: We believe that washing blood transfusions given to children following open heart     surgery will decrease their inflammatory response and improve their overall health.   "
218098|NCT00693511|"     The overall goal of this project is to examine the physiological and metabolic effects of a     16-week circuit-training (strength training + aerobic activities) program, with and without a     behavioral component utilizing motivational interviewing, in 45 overweight Latina adolescent     girls (14-18 years of age). This 16-week randomized control study will examine the     incremental effects of the following 3 intervention groups on insulin sensitivity, insulin     secretion, adiposity, and habitual and ad libitum physical activity:        -  Control group (delayed circuit training intervention; n=15)        -  Circuit training group (strength + aerobic training; 2 times per week; n=15)        -  Circuit training (same as above) + weekly motivational interviewing sessions (n=15)      Specific Aim 1: To examine the effects of a 16-week circuit training program on adiposity,     insulin dynamics, other associated hormones and adipocytokines, cardiorespiratory fitness,     and muscular strength in overweight Latina adolescent girls. Hypothesis 1: Participation in     the circuit-training program will result in significant improvements in both physiological     and metabolic outcomes, including: a) body composition as measured by DEXA, b) fat     distribution as measured by MRI, c) adipose tissue hormones (e.g. leptin, adiponectin, TNF-α)     as measured by fasting blood samples, d) insulin sensitivity and secretion as measured by     frequently sampled intravenous tolerance test, e) aerobic fitness as measured by the single     stage submaximal treadmill test, and f) increase muscular strength as measured by repetition     maximums.      Specific Aim 2: To examine the incremental effects of adding the motivational interviewing     sessions to the circuit training on self-selected ad libitum physical activity during a     5-hour observational period, habitual physical activity levels using 7 day accelerometry, and     the meanings and motivation to exercise using questionnaires before and after the     intervention. Hypothesis 2: The addition of motivational interviewing will encourage and     empower participants to be more active outside of the intervention and foster healthy     physical activity behaviors in daily life. Improvements in physical activity behaviors will     lead to greater improvements in all other health outcomes listed in specific aim 1 compared     to circuit training alone and control group.   "
218099|NCT00693524|"     Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a     combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab),     in comparison with a standard steroid + tacrolimus double drug regimen   "
218100|NCT00693537|"     Patients with type 2 diabetes mellitus suffer from accelerated coronary artery disease. We     will assess the effects of exercise training on coronary endothelial function, vascular     structure, and inflammation both in serum and skeletal muscle biopsies, as well as expression     of diabetes candidate genes.   "
218101|NCT00693550|"     RATIONALE: Gathering information about allergies to metals may help doctors learn whether     having an allergy to metal used in dental work increases the risk of developing oral cancer.      PURPOSE: This clinical trial is studying contact allergies to dental metal as a possible risk     factor for oral cancer.   "
218102|NCT00693563|"     The purpose of this study is to evaluate whether scheduled telephone intervention with     individuals with spinal cord injury (SCI) and their caregivers in the first year following     discharge from acute inpatient rehabilitation will reduce rehospitalizations and emergency     room visits as well as improve adjustment to SCI.   "
218103|NCT00693576|"     Patients with panel reactive antibodies have many difficulties to find a crossmatch-negative     kidney for transplantation and are at the risk of post transplantation rejection more than     other transplanted patients. We evaluated the effect of simvastatin on PRA and post     transplant outcome of these sensitized patients. We also performed a descriptive study.   "
218104|NCT00693589|"     Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts)     with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to     improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and     inflammatory markers. B-group vitamin-supplements have variable been reported to have     positive or neutral effects on endothelial function. Therefore, we want to compare the effect     of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm     resistance vessels in pts with cardiovascular disease.   "
218110|NCT00693667|"     The primary objective of this clinical study is to evaluate the effectiveness and safety of     PH3 for the prevention of osteoporosis.      The secondary objectives are to identify the optimal dosage for subsequent studies and to     provide basis for the next confirmatory study in study design, endpoints, and study     methodologies.   "
218111|NCT00693680|"     Examination of the effect of zinc supplementation on imipramine therapy in major depression.   "
218112|NCT00693693|"     The purpose of this research study is to better understand adherence to Locoid when people     use it to treat atopic dermatitis.   "
218113|NCT00693706|"     The purpose of the study is to compare the safety of & immune response to a single dose of     GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed,     egg-based trivalent influenza vaccine [Fluarix] in healthy adults.   "
218114|NCT00693719|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan and etoposide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving irinotecan together with etoposide     works in treating patients with recurrent, locally advanced, or metastatic breast cancer.   "
218153|NCT00705289|"     This 14-week non-interventional study will observe patients with rheumatoid arthritis (RA)     who are being treated with infliximab for the first time, in order to learn about their     disease characteristics. Patients in this study will be treated for RA with infliximab and in     a usual manner as decided by their physician.   "
218115|NCT00693732|"     Visceral and somatic hypersensitivity as evidence of central sensory sensitization occur in     the majority of Irritable Bowel Syndrome (IBS) patients. We recently demonstrated abnormal     endogenous pain modulation as a cause of the sensitization in IBS and identified the     underlying dysfunctional neuromatrix using functional MR-imaging (fMRI). Endogenous pain     mechanisms regulate, fine-tune and integrate sensory and homeostatic, including     neuroendocrine, immune and autonomic nervous system processes. Specific measures of     sensitization and endogenous pain modulation correlate with clinical measures of somatic and     neuropathic pain, suggesting usefulness as surrogate markers for clinical pain outcomes.     Validation of experimental measures as surrogate markers in IBS would provide a considerable     advance in pathophysiological and therapeutic research in this pharmacoeconomically     burdensome disease.   "
218116|NCT00693745|"     This is a multi-center prospective pilot clinical study to assess the utility of the Triage     NGAL Test - alone and in conjunction with the Triage BNP test - as an aid in the early risk     assessment for heart-failure-related adverse clinical outcomes (deaths, readmissions, and     additional emergent outpatient visits) through Day 30 and Day 90 in patients presenting with     acutely decompensated heart failure (HF). Its utility as an aid in the early risk assessment     for renal dysfunction in patients with acutely decompensated heart failure undergoing     treatment with IV diuretics will also be assessed.   "
218117|NCT00693758|"     The ability of a new SSFP-based BOLD MRI sequence to assess myocardial oxygenation changes in     response to coronary flow changes induced by adenosine and increased CO2-partial pressure     will be examined in healthy volunteers and patients with suspected coronary artery disease.     Also the susceptibility of a new SSFP-based BOLD sensitive MRI sequence to changes in     arterial oxygenation will be examined. This will help understand the physiologic basis of     oxygen sensitive imaging of the heart.   "
218118|NCT00693771|"     Primary objective:      To show an improvement in HbA1c control after 4 months of treatment with insulin glargine +     Oral Anti Diabetic (OAD) in patients previously uncontrolled on premixed insulin (with OAD)      Secondary objective:      Improvement of Fasting blood glucose (FPG) after 4 months treatment (% of patients treated to     target HbA1c ≤7.0% and/or FBG≤6.0mmol/L). Frequency of hypoglycemic episodes, quality of life     with basal+ OAD regimen.   "
218119|NCT00693784|"     The purpose of this study is to assess the safety of the Biostat Disc Augmentation System for     the treatment of chronic low-back (lumbar) pain due to symptomatic internal disc disruptions     (IDD) and to obtain preliminary efficacy information.   "
218120|NCT00693797|"     As there are no clinical data in cardiology about the relationship between metabolism     collagen changes and their clinical significance, the investigators will check the hypothesis     that collagen metabolism changes, detected by biochemical markers for collagen metabolism,     could predict the left ventricle remodelling and prognosis in patient with clinically     significant pressure overloaded left ventricle.   "
218121|NCT00693823|"     This study is a comparison of two different ways to treat blockage in the artery of the     thigh. The first is an older way with incisions in the groin and just above the knee. A     plastic tube is then inserted to make a bypass from the groin to the knee. The second     treatment offered is through a needle hole in the groin. A thin plastic tube covering a metal     stent is inserted into the artery and released to bypass the blockage from inside the artery.     No incisions are needed. Patients are enrolled and then selected for one treatment method or     another by chance. The patients will be followed for two years to see how the two different     treatment methods work compared to each other.   "
218122|NCT00693836|"     RATIONALE: Gathering information about genetic and environmental factors from patients with     lung cancer and their partners and first-degree relatives may help doctors learn more about     the disease.      PURPOSE: This clinical trial is looking at the patterns, causes, and control of disease in     patients with lung cancer in the North Trent (England) region.   "
218123|NCT00693849|"     The aim of this study is to identify genetic, physical (brain) and psychological (cognitive)     markers (or combinations of them) that predict specific response to a range of     antidepressants treatment (Escitalopram, Venlafaxine, Sertraline) in patients diagnosed with     major depressive disorder. This study is focused on outcomes which may impact on how     personalised medicine is implemented in depression.   "
218124|NCT00693862|"     The purpose of this study is to show that higher minimum concentration values are obtained     following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment     with corresponding dosing regimen.   "
218165|NCT00705458|"     The purpose of this study is to determine whether coronary artery CT scanning or nuclear     stress testing is better at diagnosing chest pain patients with coronary artery disease to     select appropriate candidates for coronary catheterization and re-vascularization.   "
218125|NCT00693875|"     Medical literature about awareness during general anesthesia is rare in China, and some small     sampled studies in China showed a significantly higher incidence (1.5～6%) of intra-operative     awareness compared with western countries. The investigators sponsored this multicenter,     large sampled, prospective study to determine the incidence of intra-operative awareness in     China, and the preservation effect of BIS monitor on the incidence of awareness.   "
218126|NCT00693888|"     The Geriatric Center Ulm scientifically supported a three-year pilot study (ProjektDEMENZ     Ulm), in which numerous findings on the system of care regarding people suffering from     dementia and their relatives were determined.      One of the most important conclusions is the significant lack of information on the     well-functioning network of the care system in Ulm. The full potential of the network is not     being exploited.      The situation in the Alb-Donau-Kreis - the area surrounding Ulm - is very similar.      The investigators' aim is to improve the utilization of the system of care for those     suffering from dementia in Ulm/Alb-Donau-Kreis by using a newly designed advisory approach     (Lighthouse Project on Dementia, Ulm, ULTDEM study).      The purpose of the study is to prove the effectiveness of this procedure by using a     prospective, open, randomized, controlled, interventional study.      After the randomization, the interventional group is given comprehensive, individual advice     about available treatment possibilities for people suffering from dementia.      In addition, they have the opportunity to re-evaluate their present diagnostic procedure.      The participants of the control group receive the standard treatment. Inclusion criterion is     the application of a care level ( level 0 or 1). Recruitment will take one year. A final     assessment will be taken every six months.   "
218154|NCT00705302|"     The aim of this study is to determine the long term effect of a self-help group in a patient     education program for patients with chronic obstructive pulmonary disease (COPD).   "
218128|NCT00693914|"     Children treated with radiation therapy for brain tumors are at risk for cognitive problems.     These problems have typically been demonstrated on global cognitive measures including     measures of intellectual functioning (IQ). Identification of specific areas of impairment can     assist in isolating vulnerable brain areas and developing targeted interventions.      In this study, we assess brain tumor survivors, solid tumor controls and healthy sibling     controls using measures of working memory (online maintenance and manipulation of     information) in order to identify a specific cognitive process that may underlie the observed     decline in IQ. We are also exploring relationships among working memory performance with IQ,     clinical characteristics and a specific genetic factor of interest.   "
218129|NCT00693927|"     Prospective randomized study of allogeneic minitransplantation from HLA-identical family or     unrelated donors comparing unmanipulated or CD8-depleted PBSC. The conditioning regimen will     be 2 Gy TBI alone (related donor with low-risk of transplant rejection) or 2 Gy TBI and 3 x     30 mg/m2 fludarabine (unrelated donor or high risk of transplant rejection). Patients will     receive a short but intensive immunosuppressive treatment (cyclosporine and mycophenolate     mofetil) to ensure both graft-versus-host and host-versus-graft tolerance. The rationale for     using PBSC instead of marrow transplant is to avoid general anesthesia of the donor and to     minimize the risk of rejection. The rationale for CD8+ depletion is to diminish the risk of     GVHD after PBSC transplantation or DLI.   "
218130|NCT00693940|"     Lower extremity peripheral arterial disease (PAD) is a disease in which fatty build-up, or     plaque, accumulates in the arteries of the legs. People with lower extremity PAD often     experience leg pain while walking, which is caused by reduced blood flow to the legs. Regular     walking has significant benefits for people with blood flow problems in their legs, but     previous studies have shown that most men and women with PAD do not walk for exercise on a     regular basis. A group home-based walking program may help people with PAD to walk more often     and improve their lower extremity functioning. This study will evaluate the effectiveness of     a home-based group mediated cognitive behavioral (GMCB) exercise program in helping people     with lower extremity PAD to increase their walking frequency and improve their lower leg     functioning.   "
218131|NCT00693953|"     Individuals with Autism Spectrum Disorder will have abnormal DESA® results. Our objective is     to use neuroelectrical measures to determine the degree of processing abnormalities in     individuals with Autism. The study will survey processing patterns and will locate and     evaluate the degree(s) of abnormalities for further study. The abnormal results of     comprehensive neuroelectrical evaluations of individuals with Autism when compared to the     normative database will provide objective, verifiable, neurophysiological information with     which to form novel approaches to the disorder.   "
218132|NCT00693966|"     The purpose of this Phase II study is to provide data regarding the safety and immunogenicity     for a range of dose levels of MEDI-517 in women who are HPV-16/18 seronegative and negative     for high-risk HPV DNA. The study is designed to evaluate safety and immunogenicity data for     MEDI-517 when formulated with either AS04 or aluminum hydroxide. Extended follow-up will     provide long-term immune response data.      This study was originally performed by MedImmune. However, GSK is now responsible for the     clinical development of the HPV vaccine.   "
218133|NCT00693979|"     This study is to compare the safety and performance of two stents coated with the same drug     (the TAXUS Element Paclitaxel-Eluting Coronary Stent System and the TAXUS Express2     Paclitaxel-Eluting Coronary Stent System).   "
218134|NCT00693992|"     This randomized phase III trial studies sunitinib malate to see how well it works when given     as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients     with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with     combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth and by blocking the growth of new blood vessels     necessary for tumor growth. It is not yet known whether sunitinib malate is effective in     helping tumors continue to shrink or stop growing.   "
218135|NCT00694005|"     Few data are available about the late patency of side branches in association with the     currently used stent types and implantation techniques.   "
218136|NCT00699426|"     To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk     factors on type 2 diabetic patients.      Study Hypothesis:        1. Nexium causes an increased gastrin secretion that increases the insulin secretion and          thereby a reduction of HbA1c        2. Probiotics changes the gut flora and bloodpressure        3. Probiotics causes a change in inflammation and thrombosis.   "
218137|NCT00699439|"     The primary idea is that the use of a computerized reminder system to help with the guideline     implementation will increase utilization and adherence of guideline-driven care, leading to     improved patient outcomes. The hypothesis we aim to address is that an automatic,     computerized reminder system for detecting asthma patients in the pediatric ED will increase     paper-based guideline utilization compared to paper-based guideline without the system.      We aim to implement a real-time, computerized asthma detection system and integrate the     system with the pediatric emergency department information system, and evaluate the effect of     the asthma detection system on reminding clinicians to use the paper-based asthma guideline.   "
218138|NCT00699452|"     The present study defines a blinded, randomized, placebo-controlled, prospective study, the     aim of which is to determine the influence of effective treatment with Type 1 angiotensin II     (Ang II) receptor (AT-1R) antagonist, using candesartan (target dose 16 mg) on stenotic     aortic valves. The investigators will specifically quantify whether candesartan attenuates     the key pathogenic mechanisms of aortic valve stenosis, namely inflammation, fibrosis,     elastin degradation, calcification, and neovascularization.   "
218139|NCT00699465|"     -  To evaluate the efficacy of using IPC during the acute phase of ICH in the prevention of          VTE.        -  To assess the safety and efficacy of additional therapy with enoxaparin.        -  To compare the efficacy and safety of the European and American guideline          recommendations.        -  To provide an efficient and safe thromboprophylaxis for several weeks until the patient          is able to walk.   "
218155|NCT00705315|"     This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus     bevacizumab as first line treatment in patients with metastatic and HER2 negative breast     cancer.   "
218140|NCT00699478|"     Pernicious anemia develops in 50% of total gastrectomized due to gastric cancer patients.     Lack of intrinsic factor, which is secreted by parietal cell from stomach wall causes     deficiency of cobalamin, which, in final, causes pernicious anemia. Thus, patients who had     undergone total gastrectomy needs to be provided externally with cobalamin. Until now,     intramuscular injection of cyanocobalamin has been the choice of treatment for cobalamin     deficiency, but it has demerits in that it causes discomfort of coming to the hospital to get     an injection, and in its high costs.      However, in pernicious anemia in old age and absorption disorder patients, it has been     reported that oral administration of cobalamin had effect of elevating serum vitamin B12.     Thus, this study was designed to prove the effect of oral administration of vitamin B12 in     total gastrectomized patients with cobalamin deficiency.   "
218141|NCT00699491|"     This phase I/II trial is studying the side effects and best dose of IMC-A12 when given     together with temsirolimus and to see how well they work in treating patients with locally     recurrent or metastatic breast cancer. Monoclonal antibodies, such as cixutumumab, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them.     Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Giving IMC-A12 together with temsirolimus may kill more tumor cells.   "
218142|NCT00699504|"     To assess the safety of cangrelor on cardiac repolarization as measured by electrocardiogram     (ECG) at therapeutic and supratherapeutic doses.   "
218143|NCT00699517|"     The primary objective of the study is to compare the progression-free survival (PFS) in the 2     treatment arms      The secondary objectives of the study are :        -  To compare the overall survival in the 2 treatment arms        -  To compare the objective response rate in the 2 treatment arms        -  To assess the safety profile of AVE8062 (in combination with the background cisplatin          therapy)        -  To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a          population approach, in all patients enrolled in selected centers.   "
218144|NCT00699530|"     The purpose of this study is to investigate the effects of chronic elevated levels of     Prolactin on metabolism and insulin sensitivity by studying patients with hyperprolactinemia     before and after treatment.   "
218145|NCT00699543|"     Objectives      : To evaluate the clinical efficacy, angiographic outcomes, and safety of the new     paclitaxel-eluting coronary stent (CoroflexTM Please, B Braun, Germany), compared with     another paclitaxel-eluting coronary stent system (TaxusTM, Boston Scientific, USA) in the     treatment of coronary stenosis.      Study Design      : Prospective, open label, 2: 1 randomized multi-center trial. Patients will be randomized     according to the type of drug eluting stent ( CoroflexTM Please vs. TaxusTM). Randomization     will also be stratified per hospital for the presence of DM and the presence of long lesions     (lesion length > 28mm)      Patient Enrollment      :915 patients enrolled at 13 centers in Korea.      Patient Follow-Up      :Clinical follow-up will occur at 1, 4, 9, 12 months and 2, 3years after intervention.     Investigator or designee may conduct follow-up as telephone contacts or office visits.      Primary Endpoint      :Clinically driven Target vessel Revascularization (TVR) at 9 months.      Secondary Endpoints      :A. Clinical safety and efficacy end points        1. Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction          (Q-wave and non-Q wave), TVR)        2. Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically          driven TVR)        3. Stent thrombosis      B. Angiographic efficacy end points        1. in-stent binary restenosis by QCA        2. in-stent and in-lesion late loss by QCA        3. in-stent and in-lesion MLD and percentage diameter stenosis by QCA immediately after the          index procedure and at 9 months of follow-up   "
218146|NCT00699556|"     This study examines the effect of combined nicotine replacement therapy (transdermal patch +     nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and     self-administration behavior.   "
218147|NCT00699569|"     To study the effect of daily intake of hyperimmune colostrum on prevention and treatment of     oral mucositis in patients with head and neck cancer undergoing high-dose radiation.   "
218148|NCT00699582|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel     when given as an adjunctive therapy in subjects with refractory partial seizures.   "
218166|NCT00705471|"     A multi-centre retrospective review of fistulizing Crohn's disease (CD) patient charts will     capture data to measure health care resource utilization associated with the use of     Infliximab for treatment of CD. Three health science centres/hospitals from Ontario are     targeted to participate in the study, each site is expected to provide 30-40 patient charts     with a target of 108 charts total.   "
218149|NCT00699595|"     To investigate if labor pain is affected by mother's hormone levels.      The hormonal effects of pregnancy are well documented. Although differences in pain     sensitivity between women and men are partly attributable to social conditioning and to     psychosocial factors, many laboratory studies of humans have described sex differences in     sensitivity to noxious stimuli, suggesting that biological mechanisms underlie such     differences. Some animal studies have suggested that sensitivity to pain decreases during     pregnancy because of the progressive activation of endogenous pain inhibitory systems. This     effect may be mediated by pregnancy-associated hormones, in particular progesterone.   "
218150|NCT00705250|"     The standard treatment for patients with HL that has not responded to treatment or has come     back after treatment is stem cell transplant. When patients are not eligible for transplant     or when HL comes back after transplant, there are no standard treatment options. These     patients can receive chemotherapy or participate in clinical trials. Bendamustine HCl is a     chemotherapy agent that is effective in treating patients with various diseases, including     non-Hodgkin's lymphoma, multiple myeloma, and breast cancer. It was recently approved for the     treatment of chronic lymphocytic leukemia. In addition, small studies from Eastern Europe     have shown that bendamustine HCl is likely effective for treating HL. This study will find     out the effect of bendamustine HCl for transplant-ineligible patients with HL that has not     responded to or has come back after treatment.   "
218151|NCT00705263|"     The current gold standard for treatment of chronic hepatitis C is pegylated interferon plus     ribavirin. Drug administration accuracy and ease of use will definitely determine treatment     effectiveness. This is the idea behind the development and usage of the PegIntron pen     (PegPen). Therefore, it is worthwhile to evaluate patients' satisfaction with this novel     device. The results of the study will be used to improve PegPen training techniques for     patients and health care providers.   "
218152|NCT00705276|"     To prove the absence of photo irritation and photo sensitivity potential of the product     Dermacyd Femina Delicata.   "
218156|NCT00705328|"     This study is designed to provide clear evidence for health and social policymakers about the     influence of alternate service-delivery models and practices on enhancing and sustaining     low-income family linkages to available services. A challenge faced by Canadian health and     social service providers is to promote health for low-income families in a proactive and     cost-effective manner. Families with low incomes experience an array of health and social     barriers that compromise their resilience, lead to negative family outcomes, and act as     barriers to available services. Family barriers are compounded by service delivery barriers     and result in reduced opportunities for effective, primary-level services and in increased     use of secondary-level services (e.g., emergency room visits, emergency intervention, police     involvement), with the obvious increase in costs. Randomized-controlled trials are rare in     community-based intervention research.      This Families First Edmonton randomized-controlled trial (RCT) will enable testing of     innovative service-delivery models and provide an opportunity for evidence-based decision     making for Canadian policy makers. Critical information will be provided about        1. optimizing cost effectiveness for public systems        2. the long-term effects on the health of low-income family members        3. mechanisms that intervene between the interventions and their effect on the health of          low-income family members        4. building on previous research and on community-based initiatives        5. promoting knowledge transfer   "
218157|NCT00705341|"     The purpose of this research is to evaluate the methacholine challenge test as an accurate     indicator of asthma in patients receiving treatment for asthma. Phase 1 on the study compares     methacholine challenge test results from asthma patients to those from people who do not have     asthma. In phase 2, test results for people with asthma on low dose inhaled corticosteroid     will be compared to results on high dose inhaled corticosteroids. Both males and females with     stable asthma (asthma participants) and without asthma (controls) enrolled. Participants will     be between 12 and 69 years of age.   "
218158|NCT00705354|"     This study will compare the incidence of post-op infection after sinus surgery using     conventional post-op oral antibiotics to the incidence of infection after sinus surgery when     a bio-resorbable antibiotic soaked nasal sponge is used in the nasal cavity in lieu of     post-op oral antibiotics. The nasal sponge is a routine nasal dressing used after sinus     surgery and will therefore be placed in all patients.   "
218159|NCT00705367|"     The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via     intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in     mainland Chinese subjects with systemic lupus erythematosus (SLE)   "
218160|NCT00705380|"     This study will evaluate the effectiveness of cognitive behavioral therapy with a panic     control treatment component in treating adolescents with panic disorder.   "
218161|NCT00705406|"     The purpose of this study is to determine whether peramivir is safe and effective in the     treatment of uncomplicated seasonal influenza.   "
218162|NCT00705419|"     Nonrandomized, prospective, observational, multi-site registry to assess long-term safety,     clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or     discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects     will be followed for up to 5 years.   "
218163|NCT00705432|"     This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG)     + Ribavirin (RBV) (weight-based dosing [WBD]) in previously untreated adult participants with     chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active     anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy     with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy     after a 4-week lead-in period may allow for both increased rates of sustained virologic     response (SVR) and shorter treatment durations (in some populations) than treatment with     PegIntron plus ribavirin alone.      The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black     participants). Participants from each cohort are assigned (randomized) to one of three study     arms, all of which have a 4-week lead-in period with (PEG + RBV).   "
218164|NCT00705445|"     Information on the mechanisms of zinc is still in developing phase. Ecological and biological     implications of long term zinc supplementation at population level requires assessment. The     trial aims to assess the impact of routine supplementation of zinc among young growing     children and evaluate its impact on intestinal microbial flora and relationship with gut     mucosa integrity and co-morbidities.   "
218168|NCT00705497|"     Background: This prospective study was designed to be the first to evaluate the toxicity of     radiofrequency ablation (RFA) in patients with recurrent pediatric solid tumors.      Methods: From 2003 through 2006, we conducted a phase I, IRB-approved study of RFA for     recurrent solid tumors. A multidisciplinary cancer management team selected appropriate     candidates for the study. Imaging-guided RFA was performed percutaneously. Response was     assessed at 3 months. Repeat RFA was performed for some incompletely ablated or new lesions.   "
218169|NCT00705510|"     To evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan)     versus an artificial tears alone in patients with meibomian gland dysfunction that have     abnormal tear quality and quantity by subjective symptoms and signs including tear breakup     time   "
218170|NCT00705523|"     The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the     treatment of alcohol dependence.   "
218182|NCT00708305|"     The purpose of this study is to investigate the efficacy of different sodium fluoride (NaF)     containing toothpastes in prevention of dental caries. Change from baseline fluoride data at     various time points up to four hours after a single brushing with NaF containing toothpastes     will be evaluated.   "
218171|NCT00705536|"     The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of     Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a     single subcutaneous (SC) injection of 20 units (U) with or without coadministration of     recombinant human hyaluronidase PH20 (rHuPH20).      The study hypothesizes that the time required to reach maximum insulin concentration (tmax)     when insulin is administered with rHuPH20 will be comparable or shorter than the time     required without rHuPH20.   "
218172|NCT00705549|"     This is a prospective pilot phase II trial, in patients with wet stage IIIb and IV NSCLC     using chemotherapy regimens which will be defined according to the pharmacogenomic profile     (tumoral expression of ERCC1, BRCA1 and RRM1) of the tumor cells.   "
218173|NCT00705562|"     The objective of the study is to assess comparative gastrointestinal tolerance of normal term     infants to various milk-protein infant formulas.   "
218174|NCT00705575|"     This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy     to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients     with Stage II hypertension over a period of 12 weeks.   "
218175|NCT00705588|"     Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in     constriction and high pressures. Treatment is given with a variety of drugs including the     prostanoid class (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors     (e.g. sildenafil).      Although these drugs are known to be effective alone, little is known about combining them     together in various combinations.      In this trial we will add a long-acting PDE-5 inhibitor to the treatment of patients with     pulmonary arterial hypertension who currently are receiving only a prostanoid drug.   "
218176|NCT00708227|"     This study will help to find out if having a certain genetic makeup influences how a person     with asthma responds to salmeterol, one of the two drugs in Advair(R).   "
218177|NCT00708240|"     Although research suggests that patients with obsessive-compulsive disorder (OCD) exhibit     specific deficits in their high cognitive processes, it is still unknown how these deficits     relate to the clinical symptoms of the disorder, and to the response to treatment. There are     two aims for the proposed research. The first is to examine how high cognitive processes and     brain activity are affected in OCD. The second aim is to investigate the effects of a     specific psychotropic medication (escitalopram) on high cognitive processes and brain     activity in OCD. We will investigate how 40 youth with OCD (recruited in specialized clinics)     differ from 40 healthy youth (recruited from the local community) on selected cognitive tests     and brain imaging paradigms, as well as explore how treatment with medication can correct or     reverse the observed differences. The final goal of our research is to learn more about the     mechanisms of action for available treatments, in order to refine and improve short- and     long-term therapeutic strategies for a highly debilitating and often lifelong disorder.   "
218178|NCT00708253|"     Background: The small bowel has been a black box for gastrointestinal (GI) endoscopy as,     until recently, most of the small bowel was not accessible with conventional endoscopes.     Double-balloon enteroscopy (DBE) is an endoscopic procedure for visualizing the entire small     bowel. The method was first described by Yamamoto and colleagues in 2001. Both endoscopic     diagnosis and treatment can be easily performed using DBE. The first larger series, recently     published, demonstrate that DBE is feasible in visualizing large parts of the small bowel.     Although DBE has widely been used routinely for examining the small intestine there are a few     issues which may limit its use. The preparation and handling of the DBE-endoscope is often     interpreted as being complex (such as attaching the balloon to the tip of the endoscope,     inflating/deflating the two balloon systems).      Recently, a novel balloon enteroscope system has been developed using only a single balloon     (single balloon enteroscope, SBE). SBE was designed to facilitate diagnosis and treatment of     the small bowel. The endoscopist needs to manipulate only one single balloon; thereby, time     and complexity for preparation of the system and for the examination itself may be reduced.     However, the new SBE system may be less efficient for deep intubation of the small bowel and     may cause adverse effects due to the hooking of the endoscope during straightening of the     endoscope.      Study Aim: The primary aim of the present study is to compare the new SBE system with the     standard DBE system with respect to completeness of visualisation and insertion depth of the     small bowel, as well as complications during the procedure.   "
218190|NCT00708409|"     With the current knowledge of aortic valve replacement modalities, no specific     recommendations can be given and the decision for a particular prosthesis or procedure is     rather arbitrarily. The investigators hypothesize that the autograft procedure according to     Ross is superior in terms of hemodynamic (especially regression of left ventricular     hypertrophy) and major adverse valve related events even in a long-term course   "
218191|NCT00708422|"     The purpose of this randomized, double-masked, parallel-group, multicenter study is to     evaluate ocular surface effects after the administration of travoprost with SofZia®     preservative system or Xalatan once daily for 12 weeks.   "
218256|NCT00709280|"     The purpose of this study is to assess whether 7% hypertonic saline (HS) is an effective and     safe therapy in infants and young children with CF.   "
218179|NCT00708266|"     This is a mono-center randomized controlled trial to be performed in the Center of Medical     Research (ZMF) at Medical University Graz and is composed by one screening visit (V1) and two     study visits (V2 and V3). In the visit V1, complete medical examination will be performed and     blood samples will be withdrawn to check overall conditions of the healthy volunteers. Those     who accomplish the necessary conditions will be enrolled in the trial to receive either     saline or lipid-heparin solutions in a randomized, cross-over design during visits V2 and V3.     Volunteers will arrive at ZMF after overnight fasting, when two venous catheters will be     placed in forearm veins. One venous catheter will be used for continuous infusion of     lipid-heparin solution (Intralipid 20%, 40 ml/h, Fresenius Kabi plus Heparin 250U/h, IMMUNO     Baxter AG) or saline, and Inulin (Inutest 25%, Fresenius Kabi). The second venous catheter     will be used for blood sampling (arterialized venous blood). Subsequently, two open flow     microperfusion (OFM) macro-perforated catheters will be inserted in the subcutaneous tissue     of abdominal wall for continuous sampling of interstitial fluid. Study visits will last for     28 hours for continuous sampling, with four additional hours for observation after infusion     discontinuation, during visits V2 and V3. Concentrations of different cytokines,     non-esterified fatty-acids, insulin, glucose, triglycerides and inulin will be     retrospectively quantified in the frozen samples.      The primary hypothesis is that cytokine concentrations in subcutaneous tissue and/or in     circulation can be modified by lipid-heparin infusion.   "
218180|NCT00708279|"     The purpose of this study is to assess the effectiveness of osteopathic manipulation in     decreasing angina pectoris symptoms.   "
218181|NCT00708292|"     This is a Phase I-Ib/II, open-label, multicenter study of AUY922 administered intravenously     in patients with multiple myeloma to determine the maximum tolerated dose. The Phase II part     will investigate the efficacy of AUY922 in patients with multiple myeloma. Additionally, the     study includes a Phase Ib combination part of AUY922 administered in combination with     bortezomib, to determine the maximum tolerated dose of the combination drugs in patients with     multiple myeloma.   "
218183|NCT00708318|"     This was a pilot, phase I, two-period, fasting, bioavailability, safety,and pharmacokinetic     study evaluating single dose of i.v. fentanyl (200 µg) and single doses of 2 mL or 3 mL     inhaled AeroLEF (500 µg/mL) delivered by nebulization with the AeroEclipse BAN device     administered in normal healthy non-smoking subjects.   "
218184|NCT00708331|"     The purpose of this study is to evaluate the safety and efficacy of Hydrophilic Acrylic     Intraocular Lens after cataract surgery   "
218185|NCT00708344|"     To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide     (HCTZ) using either a usual or an active elective titration regimen. The main efficacy     criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's     office with an automatic device, after a 10-week treatment period in hypertensive patients     insufficiently controlled by monotherapy.   "
218186|NCT00708357|"     Nitric oxide (NO) is a potent endothelium-derived vasodilatator that plays a major role in     the control of ocular blood flow. Endothelial NO synthase (eNOS) is one of three isoforms of     NOS producing NO through hydroxylation of L-arginine. The eNOS gene is located on the long     arm of chromosome 7, and different polymorphic variations have been identified. These single     nucleotide polymorphisms (sNP´s) have the ability to change transcription activity and     therefore enzyme levels. Recent data indicate that the T -786C polymorphism (especially the     homozygous variant) is associated with reduced eNOS activity and consequently impaired NO     production.      In the present study the investigators want to investigate if the T -786C eNOS gene     polymorphism determines choroidal and optic nerve head blood flow.   "
218187|NCT00708370|"     This study is a local PCO sponsored, interventional, non-drug study to evaluate the efficacy     of a health tele-counselling program in reducing cardiovascular risk in dyslipidemic     patients.   "
218188|NCT00708383|"     Human conception in vivo occurs in a complex milieu that includes proteins. It has been     speculated that the addition of proteins more complex than human serum albumin to culture     media may improve IVF outcomes. Whether the expense, labor and risk of adding additional     human-derived protein to IVF media are warranted is a question unanswered. Patients,     undergoing routine IVF or ICSI, will be assigned to one of two treatment groups in a     randomized, prospective clinical trial . Embryos will be cultured in either media     supplemented with human serum albumin (HSA) as a solitary protein supplement or in media     supplemented with HSA + SSS from the 2-PN stage until the time of embryo transfer. Clinical     endpoints monitored will be implantation rate, clinical pregnancy rate and live birth rate.     It is expected that the supplementation of commercial embryo culture media containing HSA     with the more complex protein source, SSS, will result in an overall increase in     implantation, clinical pregnancy, and live birth rates. In the balance, protein enrichment of     media may represent opportunities to simultaneously increase the live birth rate and reduce     the incidence of multiple gestations.   "
218189|NCT00708396|"     The purpose of the study is to evaluate tolerability and efficacy of escitalopram (Cipralex)     treatment in doses beyond 20mg (20-40 mg/d) in patients with OCD and schizophrenia, non     responsive or partially responsive to recommended doses (evaluation according to Y-BOCS).      An open label, prospective study. The study will include 20 patients recruited from the     inpatient wards and from the outpatient clinic who have a DSM-IV diagnosis of schizophrenia     or schizoaffective disorder and OCD.      Before entering the study all patients will be interviewed by 2 senior board certified     psychiatrists in order to confirm the diagnosis of schizophrenia or schizoaffective disorder     and OCD according to DSM-IV criteria.      After confirming the diagnosis of schizophrenia/schizoaffective disorder and OCD each patient     will be evaluated by PANSS, Y-BOCS and GCI-S scales. Those patients who score above 12 points     on the Y-BOCS will be eligible for the study.      Rating scales (PANSS, Y-BOCS, CGI-S, CGI-I) will be completed on a weekly basis during the     whole 13 weeks period. In addition patients will be asked to report medication side effects     and will also be clinically evaluated for side effects by the physician. Special attention     will be paid to worsening of psychosis or OC symptoms. All patients whose mental status will     deteriorate or those who cannot tolerate the drug will be dropped-out and intent to treat     analysis will be made.   "
218192|NCT00708435|"     The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N     (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by     coumarin derivatives in subjects who require immediate correction of INR (International     Normalized Ratio)and to stop an acute major bleeding.   "
218193|NCT00708448|"     This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments     using positron emission tomography (PET) imaging in 21 patients with Stage IIIB/IV or     recurrent non-small cell lung cancer (NSCLC) and an early post therapy assessment at baseline     and at various early time points (2 weeks in 7 patients, 4 weeks in 7 patients, and 6 weeks     in 7 patients) after institution of erlotinib (anti-EGFR) (Tarceva) and bevacizumab     (anti-VEGF) (Avastin) for first-line treatment of Stage IIIB/IV or recurrent non-squamous     NSCLC. The proposed PET imaging and blood derived biomarkers trial is a companion study to an     approved therapeutic trial (IRB# 24377). The therapeutic trial of erlotinib (Tarceva) and     bevacizumab (Avastin) for first-line treatment of Stage IIIB/IV or recurrent lung cancer with     drug costs exceeding $150,000 per patient/year (study drug budget exceeds $5 million) was     funded for study at the HCI and the HICCP, statewide trial network. The proposed imaging     study has been funded by the University of Utah Synergy Grant Program. The clinical imaging     biomarkers will include an assessment of tumor metabolism [Banrasch 1986, Frauwirth 2002,     Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977,     Warburg 1956, Weber 1977A, Weber] (dynamic FDG-PET); tumor proliferation [Rasey 2002,Shields     2001,Shields 1998, Vesselle 2002, Schwartz 2003] (dynamic FLT-PET); tumor blood flow and     perfusion( H215O-PET)[Lodge 2000]; and tumor blood volume of distribution ( H215O -PET)[Lodge     2000] in the same patient at baseline and then in the same patient at one of the post therapy     time points (2 weeks, 4 weeks, or 6 weeks). The investigators hypothesize that by using a set     of imaging derived biomarkers and biomarkers from blood they can predict response, either     prior to or at an earlier time point than would normally be determined with standard imaging     techniques, in patients with lung cancer receiving combined bevacizumab and erlotinib.   "
218194|NCT00708461|"     The primary aim of this research is to evaluate the efficacy of a multicomponent     worksite-based, environmental intervention in reducing weight increase and obesity over time     in working adults.   "
218195|NCT00708474|"     This study compares the fill of bone graft sites in the knee. It is hypothesized that harvest     sites, voids, and defects caused by trauma that are treated with the OsseoFit™ Porous Tissue     Matrix™ device will achieve a better fill grade than those treated with the conventional     method.   "
218196|NCT00708487|"     The potentially damaging effect of free O2 radicals to cultured embryos may be reduced by     adding scavengers to the culture media or by reducing the incubator O2 levels. However,     lowering the O2 in the culture environment can be expensive, troublesome and may not be     justifiable. The objective of this study is to evaluate the effect of lowered incubator O2     tension on live birth rates in a predominately day-5 embryo transfer program. The hypothesis     of this study is that a lowered (more physiological)oxygen concentration in embryo culture     incubators will increase live birth rates for in vitro fertilization patients. 230     first-cycle women undergoing routine IVF or ICSI with ejaculated sperm will be randomized in     a prospective clinical trial and stratified for patient age and physician. Embryos of     patients will be randomly assigned for culture in either a 21% O2 (atmospheric) or 5% O2     (reduced) environment. Clinical endpoints monitored will be rates of implantation, clinical     pregnancy, live birth and blastocyst cryopreservation.   "
218197|NCT00708500|"     This study involves treatment with boceprevir or placebo in combination with pegylated     interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) in adult     subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness     (a decrease in hepatitis C virus RNA [HCV-RNA] viral load >=2 log10 by Week 12 or     undetectable HCV-RNA at end of treatment) but who failed to achieve sustained virologic     response (SVR) on prior treatment with any combination therapy of peginterferon alpha and     RBV. This trial includes three arms, one control arm (PEG2b + RBV for 48 weeks) and two     experimental arms (PEG2b + RBV + boceprevir). One of the experimental arms, Arm 3, consists     of treatment with all three drugs for 44 weeks after the lead-in. The other experimental arm,     Arm 2, consists of all three drugs for 32 weeks after the lead-in. Participants in Arm 2 who     were undetectable for HCV-RNA at Treatment Week 8 will complete treatment at that point.     Those who were not undetectable for HCV-RNA at Treatment Week 8 will receive an additional 12     weeks of PEG2b + RBV + boceprevir placebo. It is hypothesized that the addition of a third     active anti-HCV drug may lead to more rapid viral response than therapy with two drugs, and     therefore, the addition of boceprevir to PEG2b plus RBV therapy after a 4-week lead-in period     may allow for both increased rates of SVR and shorter treatment durations (in some     populations) than treatment with peginterferon plus RBV alone.   "
218198|NCT00708513|"     The purpose of this study is to demonstrate the safety and benefit of auto-transfusion     filtered blood in patients undergoing major surgical oncology procedures.   "
218199|NCT00708526|"     The proposed study will measure the time from the end of surgery until the time patients meet     the discharge criteria from the postoperative anesthesia care unit and the time from the end     of surgery until the patients regained cognitive function after anesthesia.   "
218200|NCT00708539|"     To compare the effect of Crinone 8% administered once daily versus other vaginal progesterone     in terms of ongoing pregnancy rate 5 weeks after embryo transfer as well as patient     convenience.   "
218201|NCT00708552|"     The study is designed to investigate the efficacy, safety and tolerability of SB-742457     versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an     experimental treatment which increases the levels of certain chemicals in the brain that are     often decreased in patients with Alzheimer's disease.   "
218202|NCT00708565|"     The objective of this study is to determine if single dose administration of inhaled iloprost     will reduce pulmonary artery pressure, reduce hypoxic pulmonary vasoconstriction and improve     arterial oxygenation at rest and during exercise at high altitude.   "
218203|NCT00708578|"     Primary objective:      To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin     glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level      Secondary objective:      To compare the incidence of hypoglycemia in each treatment group   "
218204|NCT00708591|"     To determine the maximum tolerated dose, observed toxicities, and dose limiting toxicities,     and antitumor response of rapamycin plus ketoconazole in patients with advanced cancers.   "
218205|NCT00708604|"     The purpose of this study is to determine the safety of islet transplantation in patients     with type 1 diabetes who have had a successful kidney transplant and have been maintained for     at least three months on anti-rejection medications consisting of any combination of     sirolimus, tacrolimus, MMF or prednisone (5 mg/day or less). Another purpose is to determine     the effectiveness of an islet transplant in inducing insulin independence and whether or not     an islet transplant improves quality of life for kidney transplants patients with type 1     diabetes.   "
218393|NCT00710801|"     The purpose of this study is to learn about how different immunosuppressant therapies impact     on recurrent hepatitis C virus infection in the new liver after liver transplant. We will be     evaluating if Cyclosporin A has a superior effect against recurrent Hepatitis C virus (HCV)     infection than Tacrolimus.   "
218206|NCT00708617|"     Apart from Fibrotest, non-invasive markers have been validated only for chronic hepatitis C.     However as for chronic C hepatitis, non invasive tests (Fibrotest and transient elastometry)     are already used in current practice. The aim of this study is to validate the diagnostic     value of FIBROSCAN by comparison with liver histology. FIBROSCAN will be also compared to     Fibrotest and FIBROSCAN-Fibrotest association to each test alone in order to optimize this     diagnostic strategy.      Studied variables will be significant fibrosis (≥ 2 in the METAVIR score) and presence of     cirrhosis (score : F4). Diagnostic values of the scores will be expressed by sensitivity,     specificity, positive and negative predictive values, and ROC curves. Areas under ROC curve     of the scores will be compared using Z test.   "
218207|NCT00708630|"     This study aims to investigate the effect of providing additional information about possible     mild side effects of the yellow fever vaccination on the reporting of physical symptoms.     Additionally, the project aims to investigate the relationship between individual     characteristics (trait anxiety and perceived sensitivity to medication) and the reporting of     physical symptoms, as well as possible interactions between the level of information provided     and individual characteristics. We hypothesize that more information about mild symptoms     provided to participants will increase the number of reported symptoms after vaccination.   "
218208|NCT00708643|"     This study seeks to evaluate the clinical and subjective performance of a new daily     disposable soft contact lens.   "
222556|NCT00767533|"     To learn whether or not an Interferon defect in cell signaling, recently discovered in immune     cells from melanoma patients as well as breast cancer patients, is common to all cancers.   "
218209|NCT00708656|"     The purpose of this study is to compare the safety and effectiveness of dosing mesalazine 800     mg tablets (Asacol®) at 2.4 g once daily versus divided doses three times daily in the     maintenance of remission of ulcerative colitis.   "
218210|NCT00708669|"     To evaluate the procedural, short and long term clinical outcomes of the TAXUS stent compared     to Cypher stent in coronary arteries of ≥ 2.5 and ≤ 3.75 mm in the reference vessel diameter     with a lesion of ≤ 46 mm (by visual observation) in routine clinical settings in Japan.   "
218211|NCT00708682|"     The purpose of this study will be to evaluate safety, tolerability and immunogenicity of     13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations     in Mexico.   "
218212|NCT00708695|"     This study is a longitudinal follow-up of 670 primarily African-American women and their     17-year-old firstborn children enrolled since 1990 in a highly significant randomized     controlled trial (RCT) of prenatal and infancy home visiting by nurses. Nurses in this     program are charged with improving pregnancy outcomes, child health and development, and     maternal economic self-sufficiency. This follow-up examines whether earlier program effects     on maternal and child functioning lead to less violent antisocial behavior, psychopathology,     substance use and use-disorders, and risk for HIV; whether these effects are greater for     those at both genetic and environmental risk; and whether program effects replicate those     found with whites in an earlier trial.   "
218213|NCT00708708|"     This prospective observational cohort study will assess the average duration of the drug free     interval between etanercept treatment cycles in usual care settings in Germany.   "
218214|NCT00708721|"     Study and Dose Rationale The safety profile of clofarabine appears acceptable within the     target populations studied to date in the clinical studies summarized in Section 2.3.     clofarabine has demonstrated anti-cancer activity through inhibition of DNA synthesis and     repair, induction of apoptosis, and possibly through other mechanisms. The effect of     clofarabine on DNA methylation has not been determined. Numerous responses have been observed     after treatment with clofarabine in heavily pre-treated relapsed/refractory patients with ALL     or AML.      Recently 2 small studies were conducted at the M.D. Anderson Cancer Center looking at the use     of clofarabine in the treatment of MDS.31 The first study randomized patients in a Bayesian     fashion to 15 vs. 30 mg/m2 given IV daily for 5 days every 4 to 8 weeks. In the 15 mg/m2 arm     3 of 7 patients had a complete remission according to the International Working Group (IWG)32     criteria for response. In the 30 mg/m2 arm, 2 of 6 patients had a complete remission while 1     patient had hematologic improvement according to IWG criteria. In the second study, patients     were treated with oral clofarabine at a dose of 40 mg/m2 daily for 5 days every 4 to 8 weeks.     Two of 7 patients had hematologic improvement according to IWG criteria. The main toxicities     in both trials were prolonged myelosuppression and liver function abnormalities.      Preclinical animal models have shown increased clofarabine activity against multiple     different tumors with repetitive daily dosing for prolonged periods of time.33 The use of an     oral therapy is advantageous for the treatment of a chronic malignancy such as MDS.     Furthermore, based on the pre-clinical data mentioned above daily repetitive dosing over a     protracted period may provide increased efficacy. Since most MDS patients are elderly and may     not tolerate aggressive therapy, a schedule of administration of low dose oral clofarabine     over a protracted period may provide the advantage of increased efficacy without severe     toxicity. The safety of a protracted daily dosage of oral clofarabine in humans has not been     determined. The dosing scheme for this study will therefore include a dose escalating phase I     component followed by a phase II component. The starting dose will be 5 mg (fixed dose)     orally daily for 10 days. This dose will be escalated in cohorts of 3 patients as tolerated     up to a maximal dose of 15 mg (fixed dose) orally for 10 consecutive days. Note that at the     latter dose a patient will receive a total of 150 mg of clofarabine per cycle, which far     lower than the MD Anderson study of oral clofarabine in MDS whereby patients received 200     mg/m2 per cycle.      OBJECTIVES:      Study Overview The purpose of this study is to determine the efficacy and toxicity of     Clofarabine administered orally at a low daily dose for the treatment of myelodysplastic     syndromes.   "
218215|NCT00708734|"     This is a one year pilot study evaluating the feasibility of a 10 week, twice weekly, group     functional exercise sessions in individuals with knee osteoarthritis and its effect on gait     and balance measures.   "
218216|NCT00708747|"     Morbidity and mortality in patients suffering from systemic inflammatory response syndrome     (SIRS) remain high. The primary aim of the present study is to assess the efficacy of a     standardized 5% serum-protein solution containing immunoglobulins on serum cytokine levels.     The secondary aim is to evaluate survival of the patients.   "
218217|NCT00708760|"     We propose to develop and evaluate an interactive education software for administering     moderate sedation by non-anesthesiologists.   "
218218|NCT00708773|"     Describe the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan in     cancer patients with advanced solid tumors with UGT1A1 6/6 and 6/7 genotypes.   "
218219|NCT00708786|"     The purpose of this study is to report the incidence of ventricular arrhythmias correlated to     the SAS and to focus on the interest of diagnosing Sleep-disorders breathing in ICD patients.     This diagnosis will be assessed by an ambulatory nasal pressure recording with portable     multi-channel recorder associated to a complete SAS related symptoms questionnaire.This     clinical trial will be the first step to gather information about the suspected sleep     relation between ventricular arrhythmias and Sleep breathing disorders, in order to improve     the management and treatment of such arrhythmias in next generation of defibrillators which     will integrate a minute ventilation sensor able to monitor breathing.   "
218220|NCT00708799|"     The purpose of this study is to determine whether macrolide treatment of patients with severe     sepsis has an advantageous immunomodulatory and clinical effect compared to severe septic     patients without macrolide therapy. Our main hypothesis is macrolide use in addition to     standard therapy in severe septic patients has an advantageous immunomodulatory and clinical     effect compared to patients with severe sepsis not treated with a macrolide.   "
218221|NCT00708812|"     In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between     July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai     Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital.     All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy,     patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus     TC or TC alone for 3 cycles, 21 days as one cycle.   "
218222|NCT00708825|"     Background: A conventional configured prosthetic arteriovenous graft (AVG) usually wastes     most upper arm vessels that a reverse-loop design may conserve. This study examined the     feasibility of the AVG construction and its outcome.      Methods: Retrospective review of clinical outcomes of reverse-loop upper arm AVG patients.     Measures included hemodialysis function, duplex scan, procedural complications, and follow-up     interventions   "
218223|NCT00708838|"     The examination of the percentage of peripheral T cells carrying VLA-1 in ischemic heart     disease patients. The hypothesis is that the percentage levels of cells carrying this     integrin rise according to the severity of the ischemic heart disease.   "
218246|NCT00709150|"     This study will evaluate the effectiveness of culturally adapted depression treatment for     reducing depressive symptoms and improving adherence to diabetes self-care regimens in     Hispanics with depression and diabetes.   "
218224|NCT00708851|"     The purpose of this study is to determine if combining a daily at-home regimen using an LCD     Solution with a 3 times weekly outpatient narrowband UVB phototherapy regimen could be a     safe, effective, rapid, and, convenient treatment for plaque psoriasis.   "
218225|NCT00708877|"     Today, available therapies for hilar cholangiocarcinomas (CCA) are not satisfactory. Although     these tumors are rare, their study is important because of the high death rates in afflicted     patients, rivaling that of pancreatic cancer. Surgical resection offers the only current hope     for long-term survival, averaging only 20% in major series1. The reality is such that for the     majority of patients, CCA is a diagnosis of despair.      Although surgery has offered the only hope of cure, one of the major limiting factors in     achieving long-term survival following surgical resection of CCA is the technical ability to     achieve negative resection margins. The presence of malignant cells at the surgical margins     following resection is a major prognostic factor predicting recurrence and death.     Theoretically, the likelihood of achieving negative margins can be increased with total     hepatectomy and orthotopic liver transplantation (OLT). Previous experience with OLT     performed in isolation for hilar CCA's has been discouraging with dismal survival rates.     However, a recent report has demonstrated that long-term survival can occur in carefully     selected patients by combining the benefits of radiotherapy, chemosensitization, and OLT.     With this strategy, patients survival rates of 92%, 82%, and 82% at 1, 3, and 5 years after     transplantation have been achieved. It is not clear that these preliminary results can be     confirmed at other centers, nor is it clear what selection criteria should optimally be used     for this treatment strategy.      Our hypothesis is that select patients undergoing liver transplantation for CCA in the     context of multi-modality neoadjuvant therapy exhibit survival equivalent to other     established indications for liver transplantation as previously demonstrated. We will also     attempt to extend previously published criteria for liver transplantation in the setting of     CCA by offering this protocol to patients with evidence of intrahepatic disease and regional     nodal disease. Patients undergoing transplantation for CCA will be followed longitudinally     for their entire post-transplant course and compared with a matched cohort of liver     transplant recipients in regard to post-transplant survival, survival on the waiting list, as     well as complications pre-and post-transplantation. Explanted livers will be examined for the     presence of residual tumor.      Data will be collected on the rate of regional lymph node metastasis, invasion of adjacent     organs and tissues, and the rate of peritoneal metastases. The rate of tumor recurrence,     site, and time to recurrence will also be assessed.   "
218226|NCT00708890|"     The Twelve Step groups are the most available and widespread self-help groups for patients     with alcohol or drug related disorders. In a public health perspective, self-help groups     (SHGs) may be considered as a supplement to professional treatment and provide aftercare soon     as professional treatment has ended.      There is a need to investigate if U.S. findings and procedures concerning referrals from the     health services to Twelve Step Groups (TSGs) can be replicated and accommodated to a cultural     setting which is unfamiliar with these groups. There is also a particular need in the     Norwegian treatment system to develop alternative treatment strategies for patients     undergoing detoxification to improve their chances of long-term recovery, due to deficient     formal follow-up alternatives.      We plan to carry out a RCT-study. One hundred and sixty patients entering a detoxification     treatment center (Addiction Unit, Sørlandet Hospital, Kristiansand, Norway) will be assigned     to two different groups: One given standard information about TSGs (brief advice) and one     given intensive referral (motivational sessions and contact with TSG volunteers). A follow up     assessment is planned at 6 months to determine whether intensive referral results in more TSG     attendance, and if this mediates less substance use and better functioning outcomes.      This study introduces a new concept in the Norwegian health care system and relies on a     systematic cooperation with user organizations (SHGs) and user volunteers. Thus the study     focuses strongly on user resources.   "
218227|NCT00708903|"     The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart     (cardiac repolarization).   "
218228|NCT00708916|"     The purpose of this study is to determine the clinical and immunological effects of the     phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous     lupus erythematosus.   "
218229|NCT00708929|"     Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic     component. Most importantly a genetic polymorphism in the gene encoding for the complement     factor H (CFH) has been recently identified which is highly associated with an increased risk     of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated     to play a role in the development of the disease.      Given that it is known that impaired regulation of choroidal vascular tone is present in     patients with AMD, the current study seeks to investigate whether the Tyr402His polymorphism     is associated with altered choroidal autoregulation in healthy subjects. For this purpose a     total of 100 healthy volunteers will be included in order to test the hypothesis that an     impaired regulation of choroidal blood flow is present in subjects with homozygous Tyr402His     variant.   "
218230|NCT00708942|"     The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade     cervical precancerous lesions (dysplasia) in women.   "
218409|NCT00711022|"     The purpose of the study is to evaluate ASTRA TECH Implant System, OsseoSpeed™ implants, in     patients with totally edentulous upper jaws and poor bone quality and quantity, when     provisional artificial teeth are attached within 24 hours. The primary objective is to     investigate implant survival rate.   "
218231|NCT00708955|"     This study will evaluate and provide standard treatments for people with various eye     conditions. It will provide a resource for enrollment into new research protocols throughout     the Eye Institute and will allow institute specialists the opportunity to maintain their     expertise and gain additional knowledge of the course of various eye disorders. The     information obtained will allow for the evaluation of standard treatments and may lead to     ideas for future research.      People with diagnosed or undiagnosed eye disease and first-degree relatives of people with a     genetic or developmental eye disease may be eligible for this study. Participants are     evaluated and treated in the National Eye Institute. Blood or other tissue samples (e.g.,     urine, stool, hair, saliva or cheek swab) may be collected for future laboratory studies.   "
218232|NCT00708968|"     The purpose of this study is to determine if a family-based intervention (The FOCUS Program)     can improve the long-term quality of life and other psycho-social outcomes of men with     prostate cancer and their spouses.   "
218233|NCT00708981|"     The purpose of this study is to compare the progression of kidney disease in subjects with     Diabetes mellitus type 2 and Advanced Diabetic Nephropathy treated by routine follow-up as a     general care and in subjects treated by multi-factorial intervention in the Diabetes-Renal     Clinic.   "
218234|NCT00708994|"     The study examines the effects of delta-9-tetrahydrocannabinol (Δ9-THC), the principal active     ingredient of cannabis, on neural synchrony. Neural synchrony is studied using     electroencephalography (EEG).   "
218273|NCT00709501|"     The purpose of the study is to determine whether using a web-based weight loss website can     help overweight individuals lose weight.   "
218397|NCT00710853|"     The purpose of this study is to compare the effects of an 8-week intervention using YiRen     Qigong, Tai Chi or Hatha yoga in older adults (age 70 and above) residing at a Gencare senior     living facility. Outcome measures completed at the beginning and end of each intervention     period will be blood pressure, heart rate, perceived quality of life (PQOL)and a symptoms     questionnaire (SF-36), ability and speed of walking 20 feet (for ambulatory participants),     and neck and arm range of motion.   "
218235|NCT00709007|"     Though the HIV epidemic in India is predominantly among heterosexual populations, it is     estimated that there are approximately 1.1 million injection drug users (IDUs) in India with     HIV prevalence as high as 64% among IDUs in certain cities. In April 2004, the government of     India launched a free-antiretroviral therapy roll-out program aimed at initiating 100,000     persons on HAART. Similar guidelines are currently being followed for the delivery and choice     of HAART for IDU and non-IDU populations. However, IDUs have certain issues that complicate     the delivery of HAART that need to be addressed by delivery programs such as delayed access     to care, poor perceived adherence, and more rapid disease progression. This proposal will     assess the feasibility and effectiveness of directly administered antiretroviral therapy     (DAART) in conjunction with opioid substitution as a mode of delivery of HAART to IDUs in     Chennai, India. To evaluate this objective we will conduct a randomized controlled pilot     study of DAART vs self-administered therapy (SAT) among 100 HIV-1 infected treatment naïve     IDUs who are enrolled in an opioid substitution program in Chennai and compare the following     outcomes between the two arms: Primary Endpoint: Proportion of participants with viral load     (VL) <400 copies/ml at 24 and 48 weeks; Secondary Endpoints: (1) Incidence of mortality and     AIDS-defining illnesses at 24 and 48 weeks, (2) Changes in absolute CD4+ count from baseline     at 24 and 48 weeks, and (3) Incidence of antiretroviral drug resistance at 24 and 48 weeks.     Intention-to-treat analyses will be used. The study objective is in line with the priority     areas identified in the Indian National AIDS Control Program Phase III (NACP III) and the     results of this study will help inform the government of India on appropriate modes of     delivery of HAART to IDUs. This study will also be among the first studies to be conducted in     India to evaluate two different modes of delivery of HAART to IDUs.   "
218236|NCT00709020|"     RATIONALE: White button mushroom extract may stop or delay the recurrence of breast cancer in     postmenopausal breast cancer survivors.      PURPOSE: This phase I trial is studying the side effects and best dose of white button     mushroom extract in preventing the recurrence of breast cancer in postmenopausal women who     are breast cancer survivors.   "
218237|NCT00709033|"     Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma or     chronic Lymphocytic Leukemia. Their lymphoma or CLL has come back or has not gone away after     treatment. Because there is no standard treatment for the cancer at this time or because the     currently used treatments do not work fully in all cases, patients are being asked to     volunteer to take part in a gene transfer research study using special immune cells.      The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancers. This research study combines two different ways of fighting disease:     antibodies and T cells. Antibodies are types of proteins that protect the body from     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special     infection-fighting blood cells that can kill other cells, including cells infected with     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with     cancers. They have shown promise, but have not been strong enough to cure most patients.      The antibody used in this study is called anti-CD19. This antibody sticks to lymphoma cells     because of a substance on the outside of these cells called CD19. CD19 antibodies have been     used to treat people with lymphoma and CLL. For this study, the anti-CD19 antibody has been     changed so that instead of floating free in the blood it is now attached to T cells. When an     antibody is joined to a T cell in this way it is called a chimeric receptor. These chimeric     receptor-T cells seem to be able to kill tumors, but they don't last very long and so their     chances of fighting the cancer are limited.      Investigators found that T cells work better if they also attach a protein called CD28 to the     T cells. This protein makes the T cells more active and survive longer.      Also they found that T cells that are also trained to recognize the virus that causes     infectious mononucleosis (called Epstein Barr Virus or EBV) can stay in the blood stream for     many years.      These CD19-CD28 chimeric receptor T cells and CD19 chimeric-EBV specific T cells are     investigational products not approved by the FDA.      The purpose of this study is to find the biggest dose of chimeric T cells that is safe to     administer, to see how long each of the T cell populations (CD19-CD28 and CD19-EBV-specific)     last, to assess what the side effects are, and to evaluate whether this therapy might help     people with lymphoma or CLL.   "
218238|NCT00709046|"     The study was designed to evaluate the efficacy an adjuvant use of standard dose or high dose     of proton pump inhibitor after combined endoscopic hemostasis therapy.   "
218239|NCT00709059|"     The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol     combination in treating patients with chronic hepatitis C in a primary care setting. Patients     received no antiviral therapy prior to the current study. Only patients infected with     Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will     also explore the influence of liver fibrosis stage on the chances of achieving a sustained     virologic response.   "
218240|NCT00709072|"     This study aims to determine the percentage and predictors of stuttering relapse following     treatment with the Lidcombe Program. It will also investigate the effectiveness of sending     reminder messages to parents to assist in reducing relapse.   "
218241|NCT00709085|"     The purpose of this study is to identify genetic determinants of susceptibility to liver     cirrhosis and hepatocellular carcinoma. It will assist in predicting individual risks of     disease progression and would help to clarify pathophysiologic mechanisms of liver cirrhosis     and hepatocellular carcinoma.   "
218254|NCT00709254|"     This study was designed to assess single-dose and multiple-dose PK and safety parameters     utilizing a dosage of 3 mL (500 µg/mL)AeroLEF delivered via nebulization with the AeroEclipse     BAN device. The study was conducted in opioid naïve subjects who were not blocked with     naloxone or other opioid receptor antagonists.   "
218242|NCT00709098|"     Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial     hypertension in New York Heart Association (NYHA) class II to IV , naive to PAH treatment or     currently being treated with a stable dose of either bosentan or sildenafil and who complete     PROWESS 15 will be enrolled in the PROWESS 15 Extension study. This is a double-blind (12     week), randomized study to compare the safety and tolerability of inhaled iloprost power     disc-15 and power disc-6 in patients with symptomatic pulmonary arterial hypertension (PAH).     After completion of the double blind period, patients will be entered in the open label     period using iloprost power disc-15.   "
218243|NCT00709111|"     Despite viral suppression, antiretroviral therapy (ART) does not restore CD4+ T-cell counts     in some subjects. The purpose of this study is to assess whether adding maraviroc (MVC) to a     suppressive ART will result in a significant CD4+ T-cell count increase over 24 weeks in     subjects with suboptimal CD4+ T-cell recovery despite sustained virologic suppression.   "
218244|NCT00709124|"     The purpose of this study is to investigate whether neuromuscular electrostimulation (NMES)     will decrease ICU-associated weakness. The investigators believe that 60 minutes of daily     NMES will improve strength and function in those who have had extended ICU stays, as well as     decrease critical illness myopathy as an etiology of weakness in the critically ill.   "
218245|NCT00709137|"     Joint National Committee 7 (JNC-7) defines resistant hypertension as a persistent elevation     of blood pressure (BP) above goal - ≥ 140/90 mm Hg for the general hypertensive population or     ≥ 130/80 mm Hg for persons with diabetes mellitus or chronic kidney disease - for at least     three months despite treatment with three or more optimally dosed antihypertensive agents,     including a diuretic. The exact prevalence of resistant hypertension is uncertain but may     include 5-20% of hypertensive persons in primary care settings and 15-35% of the older,     higher cardiovascular risk hypertensive patients incorporated into recent clinical trials of     antihypertensive therapy. Observational studies demonstrate that patients with resistant     hypertension experience a higher rate of cardiovascular and renal target organ damage such as     left ventricular hypertrophy, microalbuminuria, and renal insufficiency and more     cardiovascular disease (CVD) events than patients whose hypertension is well-controlled.     Additionally, resistant hypertension patients may be subjected to the considerable expense of     multiple office visits, diagnostic testing for secondary causes of hypertension, and referral     to hypertension specialists. Because multiple factors can contribute to resistant     hypertension, an explicit, sequential approach to evaluation and management is essential to     optimize blood pressure, reduce cardiorenal morbidity and mortality, and avoid unnecessary     expense. A number of observational studies have suggested the potential efficacy of both     spironolactone and amiloride when added to a 3 drug antihypertensive regimen, but to date no     randomized study has directly compared the two agents. The goal of this study is to determine     whether spironolactone or amiloride is the more effective fourth agent to add to a three drug     regimen in patients with resistant hypertension.   "
218247|NCT00709163|"     Nesiritide is a rapid vasodilator that mimics the action of an endogenous hormone - human     B-type natriuretic peptide (BNP). BNP is produced naturally in the ventricles of the heart in     response to stretch.      Nesiritide decreases systemic vascular resistance (SVR), pulmonary capillary wedge pressure     (PCWP), right atrial pressure (RAP), and mean pulmonary arterial pressure. Nesiritide does     not affect the heart rate, but does increase the stroke volume and consequently cardiac     output, resulting in a decrease in the symptoms of decompensated heart failure. It is     generally well tolerated, with the major negative side effect being hypotension. When     compared to standard therapy consisting of dobutamine and nitroglycerin, nesiritide had     similar vasodilatory effects, but showed a lower incidence of arrhythmia.      Nesiritide has been approved for IV treatment of patients with acutely decompensated     congestive heart failure. Although studies have tested the effectiveness and safety of     nesiritide in adult CHF patients, this has not been done in children.      Subjects enrolled in this study will be pediatric (<21 years) patients carrying a diagnosis     of dilated cardiomyopathy with decompensated congestive heart failure. The standard of care     for these patients is to undergo cardiac catheterization with placement of a Swan-Ganz     catheter for hemodynamic monitoring. Subjects will be randomly assigned to receive either     Nesiritide or placebo (5% Dextrose). The infusion will then be continued for a total of     twenty-four hours. During this one day period, measurements of systemic blood pressure,     central venous pressure (right atrial pressure), pulmonary capillary wedge pressure, cardiac     output, mixed venous saturation, pulmonary vascular resistance, and systemic vascular     resistance will be measured at regularly scheduled intervals. The Swan-Ganz catheter will     remain in place for 2 hours after the discontinuation of study drug, and then removed.      The objectives of this study are:        1. To assess the efficacy of Nesiritide therapy in decreasing the pulmonary capillary wedge          pressure, right atrial pressure, and systemic vascular resistance in children with          dilated cardiomyopathy.        2. To assess the efficacy of Nesiritide in decreasing pulmonary edema and increasing          cardiac index in the above mentioned population.        3. To assess the safety of both bolus administration and continuous infusion of Nesiritide          in children with dilated cardiomyopathy.        4. To assess the pharmacokinetics of Nesiritide in this population.   "
218248|NCT00709176|"     The purpose of this study is to assess the quality of life of patients with advanced cancer     and their family caregivers and to evaluate two doses of a family-based program of care     versus control.   "
218249|NCT00709189|"     The purpose of the study is to determine the bioequivalence of NGM and EE in 2 formulations     of 250 mcg NGM/35 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid. The     pharmacokinetics of blood folate from the formulation of 250 mcg NGM/35 mcg EE containing 400     mcg folic acid and from 400 mcg folic acid administered alone is characterized.   "
218250|NCT00709202|"     The study attempts to evaluate a histamine analog long used for the treatment of Meniere's     disease , betahistine, that,.shows promise in reversing the antihistaminergic effects thought     to be involved in antipsychotic induced weight gain.      The investigators hypotheses therefore are as follows:        -  Youth who have gained a developmentally inappropriate amount of weight on SGAs will see          their weight stabilize or even decrease with betahistine augmentation as compared to          placebo augmentation.        -  Betahistine augmentation in SGA treated youth will increase levels of satiety in a          standardized meal situation and decrease caloric intake.as compared to placebo          augmentation.        -  Metabolic effects of betahistine augmentation in SGA treated youth will be reflected in          a normalization of adipose distribution when compared to placebo augmentation, in          particular with regards to the ratio of visceral to peripheral adipose tissue.        -  Betahistine augmentation in this population will lead to a normalization in physiologic          and lab values related to the development of metabolic syndrome as compared to placebo          augmentation.   "
218251|NCT00709215|"     This is a two-part, open-label, Phase I/II study in subjects with relapsed or refractory     TdT-positive leukemia for which no standard therapies are expected to result in durable     remission.   "
218252|NCT00709228|"     To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral     Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis     C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the     proportion of patients (%) with sustained virological response at 24 weeks post follow up     treatment.   "
218253|NCT00709241|"     This prospective observational study is designed to confirm the prognostic and economic     impact of depression in ambulatory patients with systolic or diastolic heart failure, to     explore the impact of other psychosocial patterns such as type D personality, anxiety     disorders, locus of control, perceived social support, anger, hopelessness, and to evaluate     potential pathophysiological and behavioral pathways.   "
218257|NCT00709293|"     The restoration of normal blood flow following a period of ischemia may result in ischemia /     reperfusion injury (I/RI), which is characterized by inflammation and oxidative damage to     tissues. Varying degrees of I/RI occur upon reperfusion of a donor heart after cold storage.     Medications containing antibodies against immune cells have been used for many years as     powerful immunosuppressants. These medications, called polyclonal antibody preparations, are     generally only used immediately following transplantation and/or to treat rejection. At our     institution, one such antibody preparation (Thymoglobulin) is used in most pediatric heart     transplant recipients for 3-5 days immediately after transplantation. Because standard     immunosuppressive medications (called calcineurin inhibitors) are toxic to the kidneys, the     use of Thymoglobulin allows us to delay the initiation of calcineurin inhibitors until the     kidneys of completely recovered from the shock of the transplant surgery.      We hypothesize that Thymoglobulin may be beneficial in reducing the damage caused by I/RI.     Thus, the present study seeks to evaluate the effectiveness of an intra-operative dose of     Thymoglobulin (in addition to the standard doses post-operatively) at reducing the effects of     I/RI. The study will be a double-bind placebo-controlled trial involving 20 subjects.     Biologic markers for I/RI will be assessed at periodic intervals for six months     post-transplantation. Subjects receiving intra-operative doses of Thymoglobulin will be     compared to the controls in order to assess the effectiveness of intra-operative     Thymoglobulin in ameliorating the effects of I/RI.   "
218325|NCT00710190|"     The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex     Hypertension Therapy System in patients with refractory hypertension.   "
218258|NCT00709306|"     The purpose of the proposed project is to investigate the efficacy and longevity of two novel     approaches to changing skin protection behaviors: 1) UV-detect photos that reveal currently     existing skin damage and 2) motivational interviewing (MI), a person-centered, yet directive     counseling style used to enhance internal motivation to change health behaviors. The proposed     investigations include a pilot study to refine the methodology; a small formal randomized     controlled efficacy trial; and a dismantling study. These studies will also expand current     knowledge and research in several major ways: 1) the use of UV-detect photos will enable     highly salient and personalized feedback, 2) MI will be used in a previously untried health     domain (skin cancer prevention), 3) objective skin color changes will be measured using     state-of-the-art skin reflectance spectrophotometry, and 4) the proposed studies will test     aspects of several major psychological theories (e.g., Transtheoretical Model,     Prototype/Willingness Model) to identify moderators/mediators of outcome.   "
218259|NCT00709319|"     The study is designed as a prospective cohort study to assess changes in visual acuity and     retinal thickening and surgical complications in subjects undergoing vitrectomy for diabetic     macular edema.      The study also aims to identify subgroups in which there appears to be a benefit of     vitrectomy and subgroups in which vitrectomy does not appear to be beneficial and to obtain     data that can be used to plan a randomized trial.      Subject will be followed through 2 years, with a primary outcome at 6 months post vitrectomy     surgery. The vitrectomy procedure will be performed based on the investigators usual care and     is not considered part of the research although the procedure performed will be collected.   "
218260|NCT00709332|"     The purpose of the study is to assess the effect of folic acid administration on the blood     level and the breakdown products of oral contraceptive (OC) [250 mcg NGM/35 mcg EE] tablets.   "
218261|NCT00709345|"     This study will evaluate the effectiveness of a cognitive behavioral treatment in reducing     significant medical risk factors often associated with people who have a serious mental     illness and are taking atypical antipsychotic medications.   "
218262|NCT00709358|"     The primary purpose is to improve and quicken the microbial diagnosis in severe infections,     since only one third of the cases are documented by blood cultures and adequate     anti-infective therapy in the 48 hours reduced mortality and morbidity.      Our hypothesis is that detection of microbial DNA in blood by real time PCR may increase the     number of cases diagnosed for bacteraemia or fungemia and shorten the time to positive     results, which will provide information for an adequate anti-infectious therapy.   "
218263|NCT00709371|"     The purpose of this study is determine if the combination of zonisamide SR and bupropion SR     are is more effective than either drug given alone or placebo in the treatment of obesity.   "
218264|NCT00709384|"     The investigators performed a prophylactic peroperative linear lesions connecting the     tricuspid annulus with a right atriotomy and the atriotomy with the inferior caval vein to     prevent atrial flutter on 15 consecutive adult patients undergoing surgery for congenital     heart disease. Conduction time between electrodes placed on both sides of the lesions is     measured on the second postoperative day. Coronary angiography and electrophysiology study     using an electroanatomic mapping system to assess conduction across the line are performed     three month after the operation.   "
218265|NCT00709397|"     This study is designed to determine how quickly HIV-1 is cleared from the blood in     treatment-experienced patients beginning a salvage therapy regimen that includes the     integrase inhibitor raltegravir. The hypothesis is that HIV-1 is cleared as rapidly in these     patients as in treatment-naive patients starting a raltegravir-based regimen.   "
218266|NCT00709410|"     The purpose of this study is to conduct cholera vaccinations in high-risk populations in     Zanzibar in order to estimate herd protection conferred by the vaccine,estimate effectiveness     of the vaccine, and describe the interaction of vaccination and improved water supply on the     burden of cholera and diarrhoeal diseases.   "
218267|NCT00709423|"     A number of common eye diseases such as retinal artery and vein occlusion, diabetic     retinopathy, age-related macular degeneration, glaucoma and anterior ischemic optic     neuropathy are associated with ocular perfusion abnormalities. Although this is well     recognized there is not much possibility to improve blood flow to the posterior pole of the     eye in these diseases.      Since many years, moxaverine is used in the therapy of perfusion abnormalities in the brain,     the heart and the extremities. This is based on a direct vasodilator effect of the drug, but     also on the rheological properties of red blood cells. Whether moxaverine affects blood flow     in the eye is unknown. The present study aims to investigate whether moxaverine may improves     blood flow in the eye after systemic administration.   "
218268|NCT00709436|"     The purpose of this research study is to evaluate the safety and analgesic efficacy of     PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain     following orthopedic trauma, injury, or surgery.   "
218269|NCT00709449|"     A number of common eye diseases such as age-related macular degeneration and glaucoma are     associated with ocular perfusion abnormalities. Although this is well recognized there is not     much possibility to improve blood flow to the posterior pole of the eye in these diseases.      For many years, moxaverine has been used in the therapy of perfusion abnormalities in the     brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the     drug, but also on the rheological properties of red blood cells. In a recent study the     investigators have shown that intravenous moxaverine increases choroidal blood flow in     healthy young subjects. The present study aims to investigate, whether moxaverine also     improves blood flow in the diseased eye after systemic administration.   "
218270|NCT00709462|"     This research study is for individuals who have advanced breast, colon, pancreatic, ovarian     or bladder cancer. Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine)     to see if it can be used to make the immune system attack the cancer. The study includes     administration of additional treatments, in combination, thought to enhance the immune     response effect. (CDX 1307-01)   "
218271|NCT00709475|"     This study is conducted in Asia. The aim of this observational study is to evaluate the     incidence of serious adverse drug reactions while using insulin detemir under normal clinical     practice conditions in the Gulf countries   "
218272|NCT00709488|"     This is a phase 1 study to evaluate the safety and effectiveness of using the Litx™ BPH     System in patients with LUTS due to benign prostatic hyperplasia (BPH).   "
218274|NCT00709514|"     The primary objective of this Phase 2 study is to evaluate the efficacy of DCB-WH1 ointment     in wound closure as compared to vehicle control when applied topically to chronic diabetic     foot ulcers for 12 weeks. The secondary objective of this study is to collect safety     information of DCB-WH1 ointment.      This is a randomized, double-blind, parallel group, vehicle-controlled, multi-center study of     DCB-WH1 ointment applied topically to grade 1 foot ulcers (according to Wagner grading     system) in 50 subjects with diabetes mellitus.   "
218275|NCT00709527|"     The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic     profile of multiple doses of ARC1905 intravitreous injection when administered in combination     with multiple doses of Lucentis® 0.5 mg/eye, or with one induction dose of Lucentis 0.5     mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related     macular degeneration (AMD).   "
218276|NCT00709540|"     This is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study     to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACE-011 in     healthy postmenopausal women.   "
218277|NCT00709553|"     The purpose of the study is to to assess the effect of multiple oral doses of ZD4054     (Zibotentan) on the pharmacokinetics of a CYP450 3A Probe (midazolam) in healthy male     subjects.   "
218278|NCT00709566|"     Hip osteoarthritis is a major cause of disability and reduced quality of life. Physiotherapy,     which encompasses a range of interventions such as exercise therapy, manual therapy,     education and electrophysical agents, is a core component of management. To date, exercise     therapy to date has the greatest evidence of effect . However, this evidence is limited as     only a short-term benefit has been identified and improvements in pain and function decline     over time. There is some limited evidence for a beneficial effect of manual therapy over     exercise. However, clinically these interventions are used in combination, not in isolation.     To date, no research has investigated the combined effect of exercise and manual therapy in     hip OA.      A multi-centre randomised controlled trial that compares the clinical effectiveness of a     combination of manual therapy and exercise to exercise therapy only will be conducted.   "
218279|NCT00709579|"     Methodology :Phase III study, single centre, double blind, versus excipient, randomised,     controlateral design.      Selection of the patients :Number of subjects required 60 :        -  30 patients needing an oral corticotherapy        -  30 patients needing a topical corticotherapy   "
218280|NCT00709592|"     One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal     Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem     cells to replace the tumor cells.   "
218281|NCT00709605|"     This study will compare the immune response and side effects of an experimental HIV vaccine     given by two different methods of administration by needle injection or by use of a     needle-free device called the Biojector 2000 (Registered Trademark). The vaccine, called     VRC-HIVADV014-00-VP, or rAd5, is made using an adenovirus that has been modified to contain     DNA that codes for three HIV proteins. It cannot cause HIV or adenoviral infections.      Healthy volunteers who are not infected with the HIV virus may be eligible for this study.     Subjects are recruited for two study groups: Group 1 comprises volunteers who are 18 to 50     years old and have never received an HIV vaccine and Group 2 comprises volunteers who are 18     to 55 years old and participated in a prior study in which they received at least one     injection of the study rAd5 vaccine.      Subjects in both groups are randomly assigned to receive the vaccine by needle or Biojector     2000 (Registered Trademark) into a muscle in the upper arm. They call a study nurse 2 days     after the injection, record their temperature and symptoms on a diary card at home for 5 days     after the injection for later review, and visit the clinic two weeks after the injection for     a checkup.      The injection is given on the day of enrollment. Additional visits are scheduled at weeks 2,     4, 12 and 24, when subjects are checked for health changes or problems, their use of     medications and how they are feeling. Blood samples are collected at all clinic visits.     Subjects are tested for HIV at the beginning and end of the study, are asked about their     sexual behavior and drug use, and are counseled about HIV risk reduction. Women are tested     for pregnancy at the beginning and end of the study.      Participants in Group 2 may undergo apheresis at the 4-week visit. This procedure is done to     collect white blood cells for tests to examine the immune response to the vaccine. Blood is     collected through a needle in the vein of one arm and directed through a machine that     separates the cell components. The white cells are removed and the rest of the blood is     returned through the same needle.      Subjects are asked about any social effects they may have experienced from participating in     the study. These effects are monitored to make sure participants receive any needed     assistance and to learn ways to prevent these problems in the future.   "
218282|NCT00709618|"     This is an open-label, single-arm, multi-center, Phase II study to determine the activity of     vinorelbine plus lapatinib in either first- or second-line setting in women with ErbB2     overexpressing metastatic breast cancer (MBC). Sixty subjects will be enrolled in the study.     Subjects will receive vinorelbine intravenously once weekly for 3 weeks, followed by a rest     week in a 4-week cycle) plus lapatinib daily. Subjects will receive treatment until disease     progression or withdrawal from the study. The primary objective of this study is to evaluate     overall tumor response rate of lapatinib in combination with vinorelbine. Secondary     objectives include progression-free survival, overall survival, duration of response, time to     response and time to progression and safety. Safety and efficacy assessments will be     performed at 4, 8 and 12 week intervals, and at the end of treatment.      Subject: Metastatic Breast Cancer, ErbB2, First-line or Second-line therapy, Lapatinib,     Vinorelbine   "
218283|NCT00709631|"     Primary aim of the study : to evaluate the prevalence of ulcerated cutaneous carcinoma or     malignant degeneration, in leg ulcers, presumed of vascular origin and without evidence of     healing despite 3 months of adequate treatmentSecondary aims of the study : to evaluate the     interest of immunostainings for desmogleins 1-2 and p16 on biopsies to differentiate between     pseudo epitheliomatous hyperplasia and squamous cell carcinoma ; and the prognosis of     diagnosed carcinomas at 12 monthsStudy hypothesis : systematic biopsies of hard-to-heal leg     ulcer may help to detect ulcerated carcinomas misdiagnosed as vascular ulcer or malignant     degeneration of leg ulcer.   "
218284|NCT00709644|"     The purpose of the study is to determine the bioequivalence of Norgestimate (NGM) and Ethinyl     Estradiol (EE) in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1     containing 400 mcg folic acid. The pharmacokinetics of blood folate from the formulation of     250 mcg NGM/25 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered     alone is characterized.   "
218326|NCT00710203|"     DPN is a disorder among darkly pigmented patients, manifested by small, benign, variants of     seborrheic keratoses, predominantly on the face.      The purpose of this study is to determine the efficacy of a 585 nm PDL for the treatment of     Dermatosis Papulosa Nigra, and compare it to therapy with curettage (scraping the lesions     off) and electrodesiccation (burning the lesions off).   "
218327|NCT00710216|"     This study examines the effect of telbivudine compared to lamivudine on the early viral     kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral     load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy.   "
218285|NCT00709657|"     Age related macula degeneration is one of the most common sight threatening diseases of the     elderly. The so called wet form of AMD is caused by choroidal neovascularisation (CNV) of     pathological vessels, which lead to leakage, bleeding and macular edema. Several lines of     evidence suggest that vascular endothelial growth factor (VEGF) plays a key role in the     induction CNV. Recent evidence indicates that overexpression of VEGF in the retinal pigment     epithelium may lead to the development of CNV in experimental models, and intravitreal     injection of a VEGF blocker prevents the development of experimental CNV. This hypothesis is     also supported by the promising effects of anti-VEGF treatment in patients with choroidal     neovascularisation. The substances currently in clinical use include ranibizumab (Lucentis®),     bevacizumab (Avastin®) and pegaptanib (Macugen®).      However, from a physiological point of view, VEGF also serves as a survival factor for     existing vessels and for neuronal cells. Moreover, it has been reported that VEGF induces     vasodilatation, most probably by an increased production of nitric oxide. Accordingly one may     hypothesize that anti-VEGF treatment is associated with ocular vasoconstriction with unknown     long term results. Thus, in the current study, the investigators set out to investigate     whether the ocular perfusion is affected by a single intravitreal anti-VEGF.   "
218286|NCT00709670|"     The aim of this study is to define the best prognostic strategy for patients presenting     suspected acute CORONARY syndrome, between MSCT and stress echocardiography.   "
218287|NCT00709683|"     This study is conducted in Africa. The aim of this observational study is to evaluate the     incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice     conditions.   "
218288|NCT00709696|"     The purpose of this study is to test the ways that a drug called varenicline helps smokers to     quit smoking. Varenicline is also called Chantix® and is approved by the United States Food     and Drug Administration (FDA) to help people quit smoking. We will test how varenicline works     by having you quit smoking and complete tasks that assess how you think and feel. We predict     that varenicline help reduce anxiety, improve attention and concentration, and reduce how     satisfying cigarettes are.   "
218289|NCT00709709|"     Many recent publications have reported encouraging results on diagnostic cardiac multislice     CT performance in 1) coronary artery disease, 2) coronary arterial bypass graft potency and     3) intrastent restenosis.      These single center studies were made on a limited number of patients (range, 50-130) and     focused mainly on one of the indications mentioned above.      Moreover, results were often given after exclusion of low quality examinations. At last, no     study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in     these populations.   "
218290|NCT00709722|"     The aim of the open multi-center study is to determine an efficient and safe dose and dosing     schedule of NKT-01 in induction of response in treatment of lupus nephritis.   "
218291|NCT00709735|"     The consolidation of learning is enhanced by adrenalin and other stress hormones. This memory     enhancing effect is opposed by propranolol. In posttraumatic stress disorder (PTSD), a     psychologically traumatic event may overstimulate stress hormones such as adrenalin, which in     turn overly strengthen consolidation of the memory of the event, leading to an excessively     powerful and persistent memory. Administration of propranolol after a psychologically     traumatic event could reduce subsequent PTSD. Unfortunately, there exists a window of     opportunity for influencing the consolidation of a traumatic event into long-term memory. In     persons who have already developed PTSD, this would have closed months or years earlier.     However, recent developments in animal research suggest that reactivation (retrieval) of a     consolidated memory can return it to a labile state, from which it must be restabilized in     order to persist. This process, which has been termed reconsolidation, can be reduced in     animals by propranolol.      In a preliminary study performed by the PI and colleagues in Canada, civilian participants     with PTSD described the traumatic event during a script preparation session, which served to     reactivate their traumatic memory. They then received either propranolol or placebo. A week     later, during script-driven imagery of their traumatic events, physiologic responses were     smaller in the participants who had received post-reactivation propranolol compared to     placebo, suggesting that the traumatic memory had been weakened by the propranolol. These     results suggest that that post-reactivation propranolol recapitulates its effects on     consolidation, this time by blocking reconsolidation of the traumatic memory.      Several important questions remain unanswered. First, does propranolol also weaken traumatic     memories in combat-related PTSD? Second, does this weakening effect only occur when the     propranolol is given after combat memory reactivation? If not, this would refute the     reconsolidation hypothesis and suggest that propranolol affects non-specific mechanisms.     Third, how long does the traumatic memory weakening last?      The proposed project will investigate these questions by performing an improved,     double-blind, placebo-controlled study in Iraq and Afghanistan veterans with combat-related     PTSD. Participants will be randomly assigned to one of two groups: post-reactivation     propranolol or non-reactivation propranolol. Participants in the non-reactivation propranolol     group will receive propranolol in the absence of traumatic memory reactivation. Participants     randomized to the post-reactivation propranolol group will receive matching placebo capsules.     Two days later, all participants will return for a script preparation session, at which time     they will describe the details of their traumatic event. Participants randomized to the     post-reactivation propranolol group will then receive propranolol, whereas participants     randomized to the non-reactivation propranolol group will receive placebo. Participants will     then return for psychophysiologic script-driven imagery testing one week and six months     later. We hypothesize that those who receive propranolol after reactivation of their memories     of their traumatic combat event(s) will show significantly smaller psychophysiologic     responses during script-driven imagery testing compared to participants who receive     propranolol in the absence of combat memory reactivation, supporting the inference that     post-reactivation propranolol blocks the reconsolidation of traumatic combat memories.   "
218292|NCT00709748|"     The purpose of this study is to determine whether transcutaneous electrical nerve stimulation     (TENS) delivered via the Empi Select TENS device provides relief of chronic lower back pain.   "
218421|NCT00712036|"     The purpose of the study is to determine whether one of three levels of counseling intensity     will be associated with better treatment outcomes when combined with methadone maintenance     treatment for heroin-addicted adults drawn from a methadone treatment program waiting list.   "
218293|NCT00709761|"     This is an open-label, single-arm, multi-center, Phase II study to determine the activity of     nab-paclitaxel plus lapatinib in the first and second-line setting in women with ErbB2     overexpressing metastatic breast cancer (MBC). Sixty subjects will be enrolled in the study.     Subjects will receive nab-paclitaxel (100 mg/m2 intravenously once weekly for 3 weeks,     followed by a rest week in a 4-week cycle) plus lapatinib (1000 mg once daily). Subjects will     receive treatment until disease progression or withdrawal from the study. The primary     objective of this study is to evaluate overall tumor response rate of lapatinib in     combination with nab-paclitaxel administered in women with ErbB2 overexpressing MBC who have     received no chemotherapeutic regimen in the metastatic setting. Secondary objectives include     progression-free survival, overall survival, duration of response, time to response and time     to progression and safety. Safety and efficacy assessments will be performed at 8 and 12 week     intervals, and at the end of treatment.      Subject: Metastatic Breast Cancer, ErbB2, First-line therapy, Lapatinib, Nab-paclitaxel   "
218294|NCT00709774|"     The aim of this study is to investigate the effects of the right ventricular septal pacing on     left ventricular function compared with right ventricular apical pacing.   "
218295|NCT00709787|"     To assess the pattern of hypertension in the population in terms of presence of additional     risk factors (ARF) and cardiovascular risk stratification.   "
218296|NCT00709800|"     The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled     in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations     with a needle and will be followed for 6 months to evaluate the safety of and the immune     system's response to the vaccine. The safety and immune system response will be studied     throughout the trial.   "
218297|NCT00709813|"     Patient-provider shared decision making and the inclusion of patients' illness experiences     and preferences in patient care are prioritized areas in health care. CHOICE is a     computer-based support system for patient-centered symptom management of cancer patients     developed for this purpose. In this randomized clinical trial at Rikshospitalet-     Radiumhospitalet HF 145 adult stem-cell transplantation and newly diagnosed lymphoma and     leukemia patients used CHOICE for assessments of their symptoms, problems and priorities for     care at in-and outpatient visits during treatment and rehabilitation. In the experimental     group this information was shared with physicians an nurses for subsequent care planning, but     not in the control group.      This study tested effects of CHOICE on symptom- related patient care and outcomes of symptom     relief, patients' needs for care over time and patient satisfaction;(2) analyzed how     patients' symptoms, needs for care varied during illness/treatment stages; and (3) evaluated     CHOICE' ease of use and user satisfaction. Controlling for gender, age, diagnosis, and     type/stage of treatment, education, depression, health related quality of life, and social     support, repeated measurement models were used to test differences and variations in outcome     variables within and between groups and over time.   "
218298|NCT00709826|"     This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with     placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.   "
218299|NCT00709839|"     The purpose of this study is to investigate the effect of hydrocortisone on glucose-induced     insulin secretion and sensitivity, by means of an intravenous glucose tolerance test with     frequent sampling (FSIGT) followed by minimal model analysis. In a randomized single-blind     cross-over design, the subjects will receive either hydrocortisone or placebo 4 minutes     before an intravenous glucose load.   "
218300|NCT00709852|"     This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called     gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look     at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol     when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol     Injection will be compared to the results of MR images taken without contrast and with the     results of the MR images taken with ProHance.   "
218301|NCT00709865|"     The purpose of the current study is to assess the safety and tolerability of intravenous     tonapofylline.   "
218302|NCT00709878|"     The purpose of this study is to characterize the microscopic findings of skin rash associated     with the use of chemotherapeutic anticancer agents known as epidermal growth factor     inhibitors (EGFRIs).   "
218303|NCT00709891|"     This study provided data on the performance of the Cobas® 4800 HPV Test for identifying     histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase was     conducted in approximately 45,000 women undergoing routine cervical cancer screening, of whom     approximately 7,400 were selected to undergo colposcopy and biopsy/endocervical curettage     (ECC) at baseline. These subjects included women with cytology that is 'not normal' and a     selection of those with 'normal' cytology who entered a follow-up phase and underwent     cytological evaluation annually for 3 years. In this follow-up phase, colposcopy and     biopsy/ECC were performed only in women with cervical cytology considered 'not normal' at any     of the annual follow-up visits.   "
218304|NCT00709904|"     The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC)     injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an     initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having     undergone hip fracture surgery.      The secondary objective is to evaluate the safety of extended AVE5026 administration.   "
218305|NCT00709917|"     This study is conducted in Europe.      The aim of this observational study is to investigate the switch from metformin alone to     metformin combined with repaglinide in type 2 diabetic patients not achieving adequate     glycaemic control on maximal dose of metformin given alone and to analyse different     epidemiological parameters.   "
218306|NCT00709930|"     This study will evaluate the efficacy and safety of weak extremely low frequency     electromagnetic fields (ELF-EMF) in mild and moderate essential hypertension.   "
218352|NCT00710541|"     Non-invasive ventilation is frequently applied in patients with acute exacerbation of COPD,     but no evidence exists about the effect of long term application/home application.      This study tests the hypothesis, that a daily, 6 hour application of non-invasive ventilation     over one year improves survival, exercise capacity, and quality of life in patients with     advanced stages of COPD.   "
218353|NCT00710554|"     The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in     relieving peripheral neuropathic pain associated with allodynia.   "
218307|NCT00709956|"     Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial     pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human     immunodeficiency virus (HIV) or drugs/toxins in New York Heart Association (NYHA) functional     class II to IV at baseline, naive to PAH treatment or currently being treated with a stable     dose of either bosentan, ambrisentan or sildenafil will be enrolled in the PROWESS 15 study.     This randomized, double blind, placebo-controlled, crossover, and single-dose study will     determine whether a single inhaled dose of iloprost using the power 15 disc improves exercise     capacity compared to placebo in patients with pulmonary arterial hypertension (PAH).   "
218308|NCT00709969|"     This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose     regimen) in African infants / children with acute uncomplicated falciparum malaria.   "
218309|NCT00709982|"     The purpose of the study is to assess the effect of folic acid administration on the blood     level and the breakdown products of OC study drug (250 mcg norgestimate[NGM]/35 mcg Ethinyl     Estradiol [EE]) tablets. The effect of study drug tablet intake on the blood level of folic     acid is also determined.   "
218310|NCT00709995|"     This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in     metastatic Renal Cell Cancer.   "
218311|NCT00710008|"     First degree relatives of type 2 diabetic patients (T2DM) suffer an increased risk of     developing this disease themselves, starting with impaired insulin sensitivity. This risk can     be minimized by lifestyle interventions such as regular exercise training. Until this day,     little is known about the short-term effects of exercise training on insulin sensitivity and     the lipid content of the liver and skeletal muscle.   "
218312|NCT00710021|"     The purpose of this study is to explore the impact of vitamin D3 on the expression of alpha     interferon (IFN alpha) expression in systemic lupus erythematosus (SLE) patients with vitamin     D deficiency.   "
218398|NCT00710866|"     The purpose of this study is to compare the antibody response and reaction rates in children     age 6-23 months when they are given either the currently recommended schedule of two 0.25ml     doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month     apart.   "
218313|NCT00710034|"     For the primary goals, we hypothesize that 1) the oral tobacco product will be more     efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2)     among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette     smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal     nicotine use will be observed during and beyond the treatment period.      For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal     symptoms and negative affect from cigarette abstinence, but smokers who are assigned to the     oral tobacco product will be more likely to report liking the effects from their assigned     product compared to those smokers assigned to medicinal nicotine; 2) greater physiological     effects (e.g., vitals) will be observed for the oral tobacco product compared to medicinal     nicotine; 3) the toxicant exposure and toxicity will be reduced dramatically when smokers     switch from cigarettes to each of these products; however, this reduction will be greater     with the use of medicinal nicotine; 4) although the abstinence rates will be higher for oral     tobacco products, and initial product costs will be lower, relative to the medicinal nicotine     intervention, the likelihood of longer duration of oral tobacco use will increase the oral     tobacco cost over time for the user; and 5) switching to low-nitrosamine oral tobacco will     reduce life-years lost compared to continuing smoking and will be a cost-effective (in terms     of life-years saved) substitution strategy compared to medicinal nicotine.   "
218314|NCT00710047|"     The purpose of the study is to assess the effect of food on the pharmacokinetics of a 10 mg     single oral dose of ZD4054 (Zibotentan)   "
218315|NCT00710060|"     This study will evaluate the effectiveness of a community-level HIV prevention program in     promoting safer sexual behaviors and reducing the transmission of HIV/sexually transmitted     diseases among at-risk populations in China, India, Peru, Russia, and Zimbabwe.   "
218316|NCT00710073|"     Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians     once conventional therapies fail.      We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in     men.   "
218317|NCT00710086|"     Labor analgesia is an essential health caring procedure for women. However, epidural     analgesia cannot be performed on all subjects for different contraindications, such as lower     platelet counter, back infection at the puncture site, and fear of epidural injection etc.     Therefore, intravenous analgesia is an alternative for such conditions. Given the influence     of intravenous administration of drugs on fetus, the drug selection is very important.     Remifentanil, a super-short efficacious opioid, can last for 3-4 minutes after injection,     which is similar in both maternal and fetal environment. Thus the fetus-associated side     effects would be less than other drugs. The investigators hypothesized that remifentanil     would be a superior intravenous drug used with patient-controlled technique for labor     analgesia.   "
218318|NCT00710099|"     Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study     investigates cutaneous microcirculation when we associate sildenafil per os with SNP via     iontophoresis.   "
218319|NCT00710112|"     The purpose of this study is to determine if sequence variations in genes involved in the     development and function of vulnerable organs increases susceptibility to chronic lung     disease (CLD) and other diseases affecting premature infants, such as necrotizing     enterocolitis (NEC), sepsis, patent ductus arteriosus (PDA) and intraventricular hemorrhage     (IVH). The study will also determine whether measurement of certain biomarkers in serum will     identify infants who will develop these complications of prematurity. Previous studies from     this institution and others have identified genetic variants in some genes, such as toll like     receptor genes are associated with higher risk of CLD or NEC. The interaction of these     variants with other gene variants that can influence the risk of these diseases remains     unclear.   "
218320|NCT00710125|"     This is a Phase 1 safety and dose escalation study to define the maximum tolerated dose (MTD)     and identify the dose limiting toxicities (DLT) following IV administration of GPX-150 once     every 3 weeks. Escalating doses starting at the dose of 14 mg/m2 and increasing to the dose     of 265 mg/m2 will be administered IV once every 3 weeks for up to 8 cycles of treatment.     Patients who have previously received an anthracycline are limited to 4 cycles of treatment.   "
218321|NCT00710138|"     During fetal life and infancy, an adequate cobalamin status is important for normal growth     and central nervous system development. During the last years we have detected cobalamin     deficiency in a number of infants admitted to the Pediatric Department with various symptoms,     including neurological symptoms and feeding problems. Cobalamin treatment is given to the     infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved     physical condition.      In this study we want to establish the prevalence of cobalamin deficiency in infants with     developmental delay and regression and other vague neurological symptoms. Cobalamin status     will be investigated in all children aged 8 months and younger, admitted to the Pediatric     Department with these symptoms. In a randomised intervention trial we will evaluate the     effect of cobalamin supplementation in children with these symptoms and metabolic evidence of     impaired cobalamin status.      Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin     deficiency, will lead to loss of symptoms and in improved physical condition.   "
218322|NCT00710151|"     This research is being done to investigate cognition in long term survivors of Primary     Central Nervous System Lymphoma (PCNSL). Sometimes caregivers as well as patients who no     longer have the disease report cognitive problems such as reduced memory or attentional     dysfunction and decreased quality of life. Unfortunately, little is known about what may     contribute to this cognitive dysfunction in part because PCNSL is a rare disease and     sensitive tests have not often been used in the research studies. This project is being     conducted to help understand what factors, such as radiation, may contribute to cognitive     dysfunction and better define the relationship between brain structure and thinking in people     who have had PCNSL.   "
218323|NCT00710164|"     This study will determine if Xiaoshuanchangrong (XSCR) capsule will improve recovery from an     acute stroke. The study is designed to look at both overall recovery and recovery of motor     function, for example muscle strength and coordination.   "
218324|NCT00710177|"     The purpose of this study is to determine if normally occurring variations in a specific gene     called PTGS-1 are associated with an increased risk of narrowing of the ductus arteriosus     from exposure to over-the-counter pain medicines (NSAIDs).   "
218328|NCT00710229|"     Angiogenesis plays a key role in the development of choroidal neovascularizations (CNV) in     age-related macular degeneration. Vascular endothelial growth factor (VEGF) is the most     important factor involved in this angiogenetic processes in the eye. This forms the basis for     new therapeutic interventions in exudative AMD. Currently two drugs have been approved by the     FDA and one drug is used off-label. All these drugs are administered intravitreally. The     present study aims to directly compare the effects ranibizumab and bevacizumab in a     randomized controlled study in patients with neovascular AMD.   "
218329|NCT00710242|"     The study is a Proof-of-concept study to evaluate if DF01 can prevent protracted labor. Time     to delivery will be measured from the time of at least 3 cm cervix dilatation and 3     contractions of minimum one minute's duration/10 minutes.   "
218330|NCT00710255|"     This research is being conducted to help us better understand what causes exercise induced     asthma. The investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and     adenosine, play an important role. The investigators will be measuring these chemicals in the     exhaled breath of volunteers with exercise induced asthma as they undergo a test to mimic     exercise induced asthma. The investigators will determine how the levels of these chemicals     change in association with how lung function changes before, during and after an episode of     exercise induced asthma.   "
218331|NCT00710268|"     Phase I, open label, dual centre, dose finding study to evaluate the safety and tolerability     of continuous twice daily oral dosing with AZD2281 when administered in combination with     Bevacizumab 10mg/kg given every 2 weeks to patients with advanced solid tumours.   "
218332|NCT00710281|"     Using phase contrast MR Angiography with NOVA® Software, this study intends to     identify,evaluate and map intracranial aneurysm development as well as develope a predicator     for future morphological changes of aneurysms and possible risk of future rupture.   "
218333|NCT00710294|"     This clinical investigation is designed to describe the long-term safety and efficacy of the     CVRx Rheos Baroreflex Hypertension Therapy System in patients who participated in the     DEBuT-HT study beyond the original follow up period (4-months or longer). The information     obtained in this trial is intended to support regulatory approvals and market release of this     therapy.   "
218334|NCT00710307|"     The purpose of the protocol is to describe the distribution of IGF-1 deficiency in the     studied population of Idiopathic Short Children without Growth Hormone Deficiency or any     other identified cause of short stature and not treated with recombinant Growth Hormone or     IGF-1   "
218335|NCT00710320|"     We aim that uncovering patients during induction of general anesthesia does not decrease core     body temperature in pediatric patients.   "
218336|NCT00710333|"     This trial will assess the safety and efficacy of 500ng Juvista per linear cm of wound margin     administered by intradermal injection following the excision of keloid scars on the ear lobe.     Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for     patients as they are very difficult to conceal and are usually bilateral. As the recurrence     rate and growth rate of keloids can vary significantly between individuals, trial subjects     will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be     treated with Juvista following keloid excision and one with placebo.   "
218337|NCT00710346|"     The purpose of this study is to collect information and tissue samples from women with     uterine fibroids. The samples will be used to study genes, proteins and other substances in     order to better understand the disease process and improve fertility and reproductive health.      Women who are scheduled to undergo hysterectomy, myomectomy or other surgery due to uterine     fibroids or to an unusual variant of fibroid disease, such as HLRCC or benign metastasizing     leiomyomatosis, may be eligible for this study.      Tissue samples are collected from participants during surgery. The samples are coded and     catalogued for research use. Data collected regarding the surgery include the sample     location, surgery type, reason for surgery and the primary and secondary diagnoses.     Additional data collected about the participant include date of birth, race, ethnicity,     weight, height, smoking status, information about menstrual cycles, medications and family     history.   "
227376|NCT00822250|"     The purpose of this study is to determine the molecular mechanism of this disease and to     research the relationship between cystinosis and skin phenotype.   "
218338|NCT00710359|"     During fetal life and infancy, an adequate cobalamin status is important for normal growth     and central nervous system development. During the last years we have detected cobalamin     deficiency in a number of infants admitted to the Pediatric Department with various symptoms,     including neurological symptoms and feeding problems. Cobalamin treatment is given to the     infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved     physical condition.      In this study we want to establish the prevalence of cobalamin deficiency in infants with     gastrointestinal symptoms and/or feeding problems. Cobalamin status will be investigated in     all children aged 8 months and younger, admitted to the Pediatric Department with these     symptoms. In a randomised intervention trial we will evaluate the effect of cobalamin     supplementation in children with these symptoms and metabolic evidence of impaired cobalamin     status.      Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin     deficiency, will lead to loss of symptoms and in improved physical condition.   "
218339|NCT00710372|"     The study medication CYT006-AngQb is a vaccine, consisting of angiotensin II (Ang II), the     naturally occurring octapeptide coupled onto the surface of virus-like particles (VLP). This     form of presenting Ang II to the immune system induces a B-cell mediated immune response     characterized by the generation of specific antibodies (IgG and IgM) against Ang II. The     CYT006-AngQb vaccine is administered by subcutaneous (s.c.) injection. Immunization against     angiotensin II may offer a valuable alternative to conventional drugs for the treatment of     hypertension.   "
218340|NCT00710385|"     The study is designed to compare the abuse liabilities of intravenous buprenorphine and     buprenorphine/naloxone in individuals who are physically dependent on sublingual     buprenorphine. We hypothesize that the abuse liability of buprenorphine/naloxone is lower     than that of buprenorphine alone.   "
218341|NCT00710398|"     Diets all share the same principle: eat less energy than you need. This results in weight     loss. However, the weight loss is usually a combination of a loss of body fat and muscle     mass. Additionally, one's bones may begin to weaken, albeit very slowly, while on a diet,     which could have serious long-term consequences. Thus, the investigators believe that the     goal of any weight loss strategy should be to lose body fat and spare muscle. The     investigators reasoning is two-fold. 1) Fat is not only stored under the skin, but also in     and around the internal organs. When this occurs, the organ itself may not function properly.     Losing fat mass is a very good thing from a health standpoint, since fat is not just a     storage site for extra energy. Scientists have now shown that 'extra' body fat itself can     actually secrete substances and when these substances get into your blood, they cause many     problems and may even contribute to the development of diabetes. 2) Sparing muscle as an     individual loses weight is very important. Muscle is a very 'metabolically active' tissue and     is, by analogy, like the body's furnace. Muscle burns fuel from the food individuals eat and     also from stored fuels, like fat. Hence, it's easy to see why you don't want to lose muscle     because you'd be losing one of your body's best fat burners. More importantly, muscle is also     a big storage site and furnace for blood sugar. In people with diabetes (elevated blood     sugar), a big part of the problem is with their muscles - they simply do not take up and     store or burn enough sugar. For these reasons, your goal should be to lose fat and preserve     muscle while dieting.      There are many different diets to choose from (e.g. high protein, low carbohydrate, high fat,     high fiber, etc.). A diet that has been shown to be quite successful, however, is one that is     higher in protein (but not excessive). Thus, in this study, the investigators are proposing     to test whether a higher protein (with dairy) and calcium diet promotes body fat loss and     muscle mass retention. The investigators believe that a diet higher in protein (with an     emphasis on dairy), but still within accepted healthy ranges, with higher dietary calcium may     result in greater loss of body fat and retention of muscle than a diet with a conventional     amount of protein and adequate calcium or a conventional amount of protein with little     calcium (i.e. low dairy). Based on previous research, the investigators think that people     with low calcium intakes to begin with would stand to benefit the most. There is also a good     reason to think that the high protein/high calcium diet may result in greater reductions in     blood cholesterol and blood sugar, both of which would reduce a person's risk for heart     disease and diabetes.      The investigators will test this diet in premenopausal women who are overweight or obese. The     investigators believe that this group is a good one to target for several reasons. First,     women of this age who are overweight or obese are, if they continue to carry this excess     weight, are at serious risk for developing chronic diseases such as heart disease, diabetes,     and possibly cancer at an early age. Second, these women will often begin to gradually     consume less dairy because many perceive dairy foods as fattening. Thus, if the investigators     proposals are correct the investigators will hopefully be able to equip health professionals     with a tried and tested, palatable, dietary strategy in a population segment who, because of     their age, would benefit greatly were their disease risk to be reduced.   "
218342|NCT00710411|"     The purpose of this study is to determine the inflammatory response after multiple trauma in     humans.   "
218343|NCT00710424|"     The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in     relieving pain due to Diabetic Neuropathy.   "
218399|NCT00710879|"     This study evaluates a multi-purpose solution when used on a daily wear basis by currently     adapted soft contact lens wearers.   "
218400|NCT00710892|"     Patients are being asked to participate in this study because they will be receiving a stem     cell transplant as treatment for their disease. As part of the stem cell transplant, they     will be given very strong doses of chemotherapy, which will kill off all their existing stem     cells. Stem cells are created in the bone marrow. They grow into different types of blood     cells that we need, including red blood cells, white blood cells, and platelets.      We have identified a close relative of the patients whose stem cells are not a perfect match     for the patient, but can be used. This type of transplant is called allogeneic, meaning     that the cells come from a donor. With this type of donor who is not a perfect match, there     is typically an increased risk of developing graft-versus-host disease (GvHD) and a longer     delay in the recovery of the immune system. Seventy to ninety percent (70-90%) of people who     receive unchanged marrow or stem cells from this type of donor will develop severe GvHD.      GvHD is a serious and sometimes fatal side effect of stem cell transplant. GvHD occurs when     the new donor cells recognize that the body tissues of the patient are different from those     of the donor. When this happens, cells in the graft may attack the host organs, primarily the     skin, liver and intestines, causing severe rashes, diarrhea, liver disease, and even death.     GvHD is caused by a type of immune cell in the graft called T cells. Because there is a high     risk of GvHD with the type of transplant the patient will receive, we will selectively remove     the T cells from the graft that the patient will receive. This process, which is called CD34     selection, is discussed in more detail in the separate consent form for the transplant.      While this stem cell selection procedure will reduce the risk of GvHD, it will also result in     slower recovery of the immune system. As the immune system is responsible for fighting     infections in the body, a longer recovery time after a transplant means that the patient may     be at increased risk for infections which can become life threatening. In some patients, the     immune system can also fight leukemia cells and reduce the risk of relapse.      In the laboratory, we have seen that cells made to carry a gene called iCasp9 can be killed     when they encounter a specific drug called AP1903. To get the iCasp9 into the T cells, we     insert it using a virus called a retrovirus that has been made for this study. The drug     (AP1903) that will be used to activate the iCasp9 is an experimental drug that has been     tested in a study in normal donors, with no bad side effects. We hope we can use this drug to     kill the T cells. Other drugs that kill or damage T cells have helped GvHD in many studies.     However we do not yet know whether AP1903 will kill T cells in humans, even though it has     worked in our experimental studies on human cells in animals. Nor do we know whether killing     the T cells will help the GvHD. Because of this uncertainty, patients who develop significant     GvHD will also receive standard therapy for this complication, in addition to the     experimental drug. We hope that having this safety switch in the T cells will let us give     higher doses of T cells that will make the immune system recover faster. These specially     treated suicide gene T cells are an investigational product not approved by the Food and     Drug Administration.   "
218344|NCT00710437|"     During elective carotid endarterectomy surgery, dexmedetomidine, an FDA approved medication,     is now given as part of our standard anesthetic regimen based upon its reported ability to     decrease anesthetic requirements and improve the peri-operative hemodynamic profile without     compromising the EEG monitoring that is used during these procedures. Although this is     consistent with our clinical impression, the effects of dexmedetomidine on the perioperative     course and EEG monitoring have not been objectively evaluated at our institution.   "
218345|NCT00710450|"     Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood.     This blood will be used to be stimulated with to whatever the patient allergic. In the     laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and     IL-3. These are chemicals responsible for allergy symptoms.   "
218346|NCT00710463|"     Hypothesis: Hospital based, comprehensive pulmonary rehabilitation of patients with COPD in     GOLD stage IV can be optimized by application of nocturnal non invasive ventilation.      This hypotheses shall be tested by an observational trial, comparing rehabilitation effects     of a prospectively observed group receiving non invasive ventilation, compared wiht a     historical control group of patients who did received the same treatment without non invasive     ventilation.   "
218347|NCT00710476|"     In order to reach fertilization in the context of IVF, the presence of high concentrations of     spermatozoa is associated with a higher degree of sperm metabolism and a higher concentration     of sperm degradation products, which may adversely affect not only sperm and oocyte viability     and the fertilization rate. The effect of a high concentration of sperm used for oocyte     insemination appears also to be negative on embryo development (Dumoulin et al 1992*). If     that is true, lowering the sperm concentration for oocyte insemination might improve embryo     quality and result in a higher implantation rate per embryo. Therefore, we tested the     hypothesis that the percentage of 8 cell-embryos on day 3 after IVF is significantly higher     (40%) after insemination with a low sperm concentration (150 000/ml spermatozoa) than after     insemination with a higher sperm concentration (30%; group 600 000/ml spermatozoa).   "
218348|NCT00710489|"     The purpose of the potential research study participant registry is to keep potential     research subjects informed about any future research studies in which they may meet the     criteria for enrollment. The purpose of this study is also to assist current and future     clinical trials with recruitment of subjects.   "
218349|NCT00710502|"     Cholecystectomy is one of the most common general surgery procedures performed in the US     today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract     disease has been estimated to cost U.S. healthcare $5 billion/year. Laparoscopic     cholecystectomy was introduced in the early 1990s and has become the standard surgical     approach for the treatment of gallbladder disease. More than 500,000 cholecystectomy     procedures are performed in the US every year. Laparoscopic cholecystectomy is now performed     as an outpatient basis and is related to a very low complication rate. Laparoscopic     cholecystectomy requires the use of multiple trocar incisions.      Natural Orifice Translumenal Endoscopic Surgery(NOTES) is a new type of surgical procedure     currently being studied around the world. The idea of NOTES was developed several years ago     in response to the concepts that patients would        1. realize the benefits of less invasive surgery by reducing the recovery time,        2. experience less physical discomfort associated with traditional procedures        3. have virtually no visible scarring following this type of surgery.      All of these advantages have spurred research and investigation forward, encouraging     physicians and researchers to develop new equipment and techniques to use during NOTES     procedures. Although the Natural Orifice Translumenal Endoscopic Surgery approach may hold     tremendous potential, there are many issues that need to be addressed before this technique     is introduced into clinical care.      The purpose of this study is to determine the safety, feasibility and short-term clinical     outcomes (Phase I trial) of transvaginal NOTES cholecystectomy in female patients with     symptomatic cholelithiasis and compare it to Laparoscopic Cholecystectomy (Phase II).      Hypothesis 1: Transvaginal NOTES cholecystectomy is safe and feasible in female patients with     symptomatic cholelithiasis.      Hypothesis 2: The short term outcomes of Transvaginal NOTES cholecystectomy are comparable to     Laparoscopic Cholecystectomy in female patients with symptomatic cholelithiasis.      Aim 1: Determine the safety of Transvaginal NOTES cholecystectomy. Aim 2: Determine the     feasibility of Transvaginal NOTES cholecystectomy. Aim 3: Determine the short-term outcomes     of Transvaginal NOTES cholecystectomy. Aim 4: Compare the short-term outcomes of Transvaginal     NOTES cholecystectomy to Laparoscopic cholecystectomy.   "
218350|NCT00710515|"     The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking     food at the same time as the capsules compared to taking capsules on an empty stomach   "
218351|NCT00710528|"     The purpose of this study is to determine the dose that can be safely given to see what     effect it may have on your cancer and to determine how the drug is distributed in the body.   "
218354|NCT00710567|"     Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the     DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge     to cardiac transplantation.      Study Population The patient population for this trial consists of patients with end stage     heart failure awaiting cardiac transplantation. Patients must be listed for transplant with     UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in     the study regardless of gender, race or ethnicity.      Study Design This is a multi-center, prospective, single arm study in which the lower     one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur     within an 18-month time period at up to 40 centers. All patients will be followed for all     endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or     death, whichever occurs first. For those patients who remain on support after 180 days,     survival and device reliability data will continue to be collected on a regular basis. If     patients are transplanted, survival at day 30 post cardiac transplantation will also be     assessed.   "
218355|NCT00710580|"     Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque     psoriasis   "
218356|NCT00710593|"     The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and     behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.   "
218396|NCT00710840|"     Osteoarthritis (OA) is a long-term degenerative joint disease that disables about 10% of     people over the age of 60 and compromises the quality of life of more than 20 million     Americans. A procedure called total knee arthroplasty (TKA), in which the affected surface of     the knee joint is replaced by plastic or metal, has been successful in restoring comfort and     mobility to formerly arthritic joints. This study will compare quadriceps muscle strength,     knee range of motion, and pain in people who have had a traditional TKA with those who have     had a minimally invasive TKA.   "
218357|NCT00710606|"     There are over 60 million women of reproductive age in the U.S. and a majority of these women     qualify as overweight or obese. Evidence suggests that there is an association between     increased body weight and decreased contraceptive efficacy. Studies with the combined     hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®)     demonstrate higher failure rates in heavier versus lighter women.      Weight related differences in the effectiveness of NuvaRing® need further study. A single     secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no     difference in pregnancy rates among women in the highest weight decile (>166#) versus the     rest of the study population using the ring. (Westhoff, 2005) The finding of no difference,     however, was influenced by too few obese subjects in the analysis which contributed to wide     confidence limits. Additional studies are needed to explore how well the contraceptive ring     functions to maintain effective serum steroid concentrations to suppress ovarian activity in     obese women.      This investigation focused on evaluating mean serum concentrations of hormones released in     obese and normal weight women using the NuvaRing® . This study was a prospective clinical     trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those     with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined     hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects     (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2)     and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers     included sonographic evidence of follicular development and ovulation as well as circulating     E2 levels which strongly correlate with follicular development and endometrial proliferation     during the second month of NuvaRing® use. Assessment of these parameters will translated to     understanding contraceptive-mediated suppression of ovarian function in these two groups.     Subjects also logged patterns of ring use and bleeding patterns during the study period.   "
218358|NCT00710619|"     This study is conducted in the United States of America (USA). The aim of this study is to     investigate the at-home-administration of bypassing agents for treatment of bleeding episodes     in patients with congenital haemophilia with inhibitors to factors VIII and IX. We are     further investigating how bleeding episodes affect the quality of life of the patient and     their family or caregivers.   "
218359|NCT00710632|"     RATIONALE: Screening tests may identify people with cancer who are at high risk of losing     weight and help doctors plan better treatment.      PURPOSE: This clinical trial is studying how well a new screening tool works in predicting     weight loss in patients with cancer.   "
218360|NCT00710645|"     This is a single-site, pilot study. In this study, we hope to learn if the Lido Workset is a     sensitive measure of limb spasticity in patients with Multiple Sclerosis (MS). The Lido     Workset is a FDA approved, non-invasive device which has been used to assess motor function     and spasticity. The testing will take approximately 25 minutes. Subjects will lie down on a     table and have a leg attached to the Lido Workset device arm. The Lido Workset will move the     leg back and forth many times at different speeds. The Lido Workset will also analyze     resistance to passive (while subject is not moving or resisting movement) movement of the     wrist and knee.   "
218361|NCT00710658|"     Cancer patients often experience multiple physical, functional and psychosocial symptoms, but     have limited support while being at home between treatments and during rehabilitation.     WebChoice is a novel Internet support system that extends traditional health services into     patients' homes. The system allows patients to monitor symptoms over time, and provides     access to evidence-based self-management options tailored to their reported symptoms as well     as a communication area where patients can ask questions to a clinical nurse specialist in     cancer care and exchange experiences with other cancer patients.      This randomized clinical trial:        1. Tests the effects of WebChoice on primary outcomes of symptom distress, quality of life,          depression and health service use, and secondary outcomes of self-efficacy, social          support . We will also analyze:        2. Relationships between primary and secondary outcomes;        3. How patients' symptom distress varies over time;        4. Patients' preferences for participation in decision making about symptom management        5. How patients use WebChoice, such as frequency of use, duration, most used components;        6. How patients' experience WebChoice's usefulness and ease of use;        7. Patterns and content of patients' communication with the cancer nurse and other          patients.      325 cancer patients (189 breast cancer and 136 prostate cancer patients) were recruited from     throughout Norway through advertisements and invitation letters and the Norwegian Cancer     Registry. Patients were randomly assigned to WebChoice or the control group that received     usual care. Patients are being followed with 5 repeated measures over 12 months. Data are     being collected through questionnaires, from system logs, and from interviews that were     conducted in subset of experimental group patients. The primary hypothesis will be tested     with Repeated Measures ANCOVA techniques. The other research questions will be answered using     various inferential and descriptive techniques and through content analysis of messages and     transcripts of patient interviews. This study can make a significant contribution to reduce     unnecessary suffering and improve the quality of life for a large group of cancer patients.   "
218362|NCT00710671|"     The proposed study will use both qualitative and quantitative research methods (mixed     methods) to gather data that will support the eventual development of interventions for young     men who have sex with men (YMSM) living with behaviorally acquired HIV infection. The overall     goal of the study is to gain an understanding of the psychosocial/developmental needs of YMSM     by focusing on two critical developmental issues—identity development and future life goals.   "
218363|NCT00710684|"     The study is designed to investigate the safety and efficacy of SB-742457 when added to     stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.   "
218364|NCT00710697|"     The purpose of this study is to investigate what effects, if any, picoplatin has on the heart     rhythm.   "
218365|NCT00710710|"     The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI     2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line     therapy. A secondary aim is to identify the most suitable dosage regimen for the further     phase II and III clinical programme of BI 2536. To achieve this objective, two dosage     regimens are compared in patients receiving first line therapy.   "
218366|NCT00702455|"     The goal of this project is to test whether a phone and mail-based program designed to help     people who have recently lost weight helps them keep the weight off over a 2 year period.   "
218367|NCT00702468|"     The purpose of this study is to evaluate the maintenance of effect after long-term treatment     with Sativex® in subjects with symptoms of spasticity due to Multiple Sclerosis (MS) who have     been receiving long-term benefit from treatment with Sativex®.   "
218368|NCT00702481|"     The purpose of this study is to define the response and toxicities with the addition of     Nimotuzumab to chemoradiation for head and neck cancer.   "
218369|NCT00702494|"     TB-403 is a monoclonal antibody directed against Placental Growth Factor (PlGF). The antibody     binds to PlGF and inhibits the binding to it's receptor, VEGF-1. By preventing this binding,     growth of tumor vessels are inhibited and tumor growth prevented.      In this study we are investigating the tolerability and safety of TB-403 in patients with     solid tumors who receives multiple intravenous doses of TB-403.   "
218370|NCT00702507|"     The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate     ointment in newborns and infants with a yeast infection in the diaper area causes the yeast     to become resistant to the drug.   "
218371|NCT00702520|"     The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, Org 36286)     treatment for the induction of multifollicular growth in women undergoing Controlled Ovarian     Stimulation (COS) prior to in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection     (ICSI) is safe for pregnant participants and their offspring.   "
218372|NCT00702533|"     Background:      - Acid-related gastrointestinal disorders are numerous and may require chronic treatment and     maintenance, but they are often difficult to diagnose and treat. Gastric analysis is a     critical tool for diagnosing and treating acid-related disorders; however, at present it     requires a technically difficult procedure, using a nasogastric tube, that is costly,     invasive, and uncomfortable. Recently a new tool, the SmartPill, has been developed that can     measure acid levels, temperature, and pressure throughout the stomach, small intestine, and     colon by swallowing a small capsule. Researchers are interested in comparing current methods     of measuring stomach acid with the SmartPill by studying both healthy volunteers and     individuals with acid-related gastrointestinal disorders.      Objectives:      - To evaluate the usefulness and accuracy of the SmartPill for gastric analysis, compared     with current procedures.      Eligibility:        -  Phase 1A/1B: Healthy volunteers between 18 and 60 years of age.        -  Phase 2: Individuals at least 18 years of age who have been diagnosed with          Zollinger-Ellison Syndrome or acid hypersecretion.        -  Phase 3: Individuals at least 18 years of age who have been diagnosed with refractory          gastroesophageal reflux disease, peptic ulcer disease, or idiopathic gastric          hypersecretion.      Design:        -  This study involves a screening visit, a 3-day inpatient study visit, and possible          additional outpatient visits.        -  Participants will be screened with a medical history and physical examination, as well          as blood and urine samples.        -  Phase 1A/1B: Participants will have a 3-day inpatient study visit with the following          procedures:        -  Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a          special diet for the next day s test.        -  Gastric analysis using a nasogastric tube to collect stomach acid secretions.        -  SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24          to 48 hours to collect readings.        -  Participants in Phase 1A will have a second outpatient SmartPill study 7 days after the          first SmartPill study. Participants in Phase 1B will not have the second SmartPill          study.        -  Phase 2 and Phase 3: Participants will have a 3-day inpatient study visit with the          following procedures:        -  Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a          special diet for the next day s test.        -  Gastric analysis using a nasogastric tube to collect stomach acid secretions.        -  SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24          to 48 hours to collect readings.        -  Phase 2 and 3 participants will have outpatient study visits only if directed by the          study researchers.   "
218373|NCT00702546|"     Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET)     cycles performed after the embryos are cryopreserved in the base study P05690 in order to     estimate the cumulative pregnancy rate for each treatment group.   "
218374|NCT00702559|"     Most patients with end-stage renal disease require hemodialysis. An arteriovenous fistula     (AVF) or a prosthetic arteriovenous graft (AVG) is the preferred accesses for this. After its     surgical creation, the fistular vein immediately faces a tremendous blood flow and the venous     lumen is gradually dilated and the wall thickened, producing an access that can be routinely     needled and deliver sufficient blood flow for dialysis. However, many hemodialysis patients     will experience access stenosis, dysfunction, and even thrombosis, which are the most common     complications of a hemodialysis access.      Most physicians, in-charge nurses of the hemodialysis unit, patient, and/or the family use     traditional stethoscope as a convenient method to evaluate the patency and function of a     hemodialysis access before, during, and after each session of dialysis. The acoustic signal     of an access is always affected by environmental noises, non-specific in nature, and the     sensitivity to detect stenosis is very low.      With the development and use of electronic stethoscope, the proprietary ambient noise     acoustically cancels out an average of 75% of distracting room noise, greatly enhancing     overall utility. However, the output acoustic signals are still apprehended by the ear, which     is the main source of bias and errors of detection.      Our study purpose is to apply the signal processing technology to transfer the acoustic     signals into simple visual signals that provide an easy way to read. It can be used by a     professional medical staff, a non-professional person responsible for taking care, or even     the patient himself, disability or not, as an early screening detector of stenosis or     dysfunction of a hemodialysis access.   "
218375|NCT00702572|"     The primary objective of the study is to establish the phase II recommended dose of     Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and     bevacizumab for patients with previously untreated advanced non-small cell lunc cancer.   "
218376|NCT00702585|"     The objectives of this trial were to investigate the feasibility and the optimal dose of a     single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group     II anovulatory infertility and to assess the safety (including the absence of antibody     formation) of Org 36286.   "
218377|NCT00702598|"     This study will investigate the additional benefits of telephone-based cognitive behavioral     therapy (Tel-CBT) as added treatment to an antidepressant (escitalopram) in working people     with major depressive disorder (MDD) versus treatment with escitalopram alone. Outcomes will     include depression symptom rating scales and measures of work absence and productivity. The     hypothesis is that Tel-CBT and escitalopram will result in better outcomes than escitalopram     alone in working patients with MDD.   "
218378|NCT00702611|"     The purpose of this study is to evaluate the efficacy of the addition of GMA apheresis to     steroid conventional treatment for achieving and maintaining remission in Active steroid     dependant Ulcerative Colitis patients   "
218481|NCT00712816|"     The purpose of the study is to evaluate the effectiveness of a device that delivers cold and     intermittent compression as compared to ice and compressive wraps on patients who have     undergone knee replacement.   "
218379|NCT00702624|"     The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286)     treatment for the induction of multifollicular growth in women undergoing controlled ovarian     stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection     (ICSI) is safe for pregnant participants and their offspring.   "
218380|NCT00702637|"     The purpose of this study is to determine whether Modafinil is effective in: (1) reducing     fatigue and excessive daytime sleepiness (EDS) in individuals with Traumatic Brain Injury     (TBI); and (2) improving cognitive function and quality of life in individuals with TBI.   "
218381|NCT00702650|"     Testosterone replacement treatment is the most effective way of treating hypogonadism in men.     Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous     solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of     this product. The study will also assess safety of the product.   "
218382|NCT00702663|"     The aim of this study is to observe and evaluate initiate serum anti-HBs titers during     entrance health examination among undergraduate freshmen in a university who showed a     complete 4-dose HBV vaccination in infancy and whose serum status was (1) HBsAg negative and     anti-HBc negative and (2) anti-HBc positive alone. For those students whose anti-HBs <10     mIU/ml, additional HBV vaccination boosters were given according to routine governmental     suggested schedules. The anamnestic effect then is observed in both groups. The results of     this study may contribute to the analysis of the effectiveness of anti-HBV vaccination twenty     years after the commencement of the program and the necessity of initiating HBV booster     program among Taiwanese young adults.   "
218383|NCT00702676|"     This study will compare the tolerability of Quetiapine Fumarate immediate release formulation     and Quetiapine Fumarate extended release formulation during initial dose escalation in     healthy volunteers.   "
218401|NCT00710905|"     The objective of this study is to prospectively evaluate the visual parameters in a series of     patients after phacoemulsification cataract surgery in a series of patients bilaterally     implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.   "
218384|NCT00702689|"     Background:      Chronic graft-versus-host disease (GVHD) is a common complication of stem cell transplant,     resulting from the donor's immune cells attacking the cells of the body of the recipient. One     effect of GVHD is fibrosis (scarring) of the skin that can lead to impaired function,     decreased quality of life and increased risk of death. This is known as sclerotic skin     changes of GVHD, or sclerodermatous graft versus host disease (ScGVHD).      Imatinib mesylate (Gleevec) is a drug that has been approved by the Food and Drug     Administration to treat cancer in humans and fibrosing conditions in animals.      Objectives:      To see if imatinib mesylate can improve ScGVHD and evaluate its effect on other GVHD symptoms      To assess the side effects of imatinib mesylate in patients with GVHD      To evaluate blood, body fluids and tissue samples in patients to try to better understand the     biology of ScGVHD      Eligibility:      Patients 4 years of age and older with ScGVHD      Design:      Initial treatment: Participants take imatinib mesylate tablets once a day for up to 6 months,     as long as their GVHD does not get worse and they do not develop unacceptable side effects of     the drug.      Evaluations: Participants are evaluated at 1, 3 and 6 months at the National Institutes of     Health (NIH) Clinical Center with procedures that may include the following:      Medical history and physical examination      Blood and urine tests      Lung function test      Skin biopsy      Magnetic resonance imaging (MRI) scan      Specialty consultations (e.g., physical or rehabilitative therapy, dentist, eye doctor,     dermatologist)      Electrocardiogram (EKG)      Echocardiogram (ultrasound test of the heart)      Muga scan (nuclear medicine test of the heart)      Quality-of-life questionnaires      Apheresis (procedure for collecting quantities of white blood cells)      Office visits with local physician once a week for 1 month, then once every 2 weeks for 5     months      Followup visits at National Institutes of Health (NIH) every 6 months for 1 year      Continuing treatment: Patients who improve continue to receive imatinib mesylate for up to 6     months after their best response and are followed for up to 2 years. Patients who continue to     respond or who become worse after stopping treatment may receive additional treatment for up     to 2 years.   "
218385|NCT00702702|"     Eligible female subjects will be randomly assigned to one of the three treatment groups.     Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily     during study drug treatment. The study duration is approximately six months, which is     comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a     one-month follow-up period.   "
218386|NCT00702715|"     The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on     efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison     to subjects with normal renal function.   "
218387|NCT00710723|"     In assisted reproduction technology (ART), cryopreservation of embryos maximizes the     potential of IVF cycles. Currently different cryopreservation methods are used, the     conventional slow freezing method and vitrification. There is, therefore an immediate need to     assess which cryopreservation technique is preferential in human IVF. In this prospective     randomised study conventional slow freezing and vitrification, using the Hemi-straw carrier     system, of human day 3 embryos were compared.   "
218388|NCT00710736|"     This is a Phase 1 study during which patients with advanced/metastatic solid tumors will     receive investigational study drug ARRY-334543 and capecitabine. Patients will receive     increasing doses of study drug in combination with capecitabine in order to achieve the     highest dose of study drug possible that will not cause unacceptable side effects. Patients     will be followed to see what side effects the combination causes and what effectiveness the     combination has, if any, in treating the cancer. Approximately 30 patients from the US and     Canada will be enrolled in this study.   "
218389|NCT00710749|"     Crossover comparison of different flow meters with a digital home flow meter as a reference.     Main hypothesis: Reapeated home flow measurements with a disposable device will provide a     better understanding of the patients urinary flow than a single measurement performed in the     clinic.   "
218390|NCT00710762|"     The primary objective of this study is to estimate the Progression Free Survival Rates (PFS)     of patients with relapsed ovarian cancer after 9 months of continuous treatment with either     BIBF 1120 or matching placebo.   "
218391|NCT00710775|"     The study will be conducted in patients who are undergoing surgical aortic valve replacement     on cardiopulmonary bypass. Following surgical access of the native aortic valve and prior to     removal of the valve, the native valve will be dilated using a standard valve dilation     balloon. The Heart Leaflet Technologies(HLT- Heart Leaflet Technologies Inc.) aortic valve     device will be released in the native valve and measurements will be taken of the device     relative to the anatomic structures of the heart. Once completed, the implant is removed from     the native valve and the surgical valve replacement procedure is completed.      The purpose of this study is to confirm that the dimensions of the HLT valve are appropriate     for patients with aortic valve stenosis.   "
218392|NCT00710788|"     Research proposal to evaluate the impact of different phosphate binders on the progression of     cardiovascular calcification and QT dispersion in new haemodialysis patients.   "
218394|NCT00710814|"     This is a pilot and feasibility study to examine a novel intervention using leptin in     weight-reduced individuals who have undergone bariatric surgery but still remain obese.     Leptin, a peptide hormone secreted from adipose tissue, is a regulator of food intake and     energy expenditure. Administration of leptin resulted in profound weight reduction in the few     reported cases of obese individuals with genetic leptin deficiency. However, most obese     people have increased leptin levels. Such individuals are said to be in a leptin-resistant     state, whereby administration of physiological concentrations of leptin are ineffective at     producing significant weight reduction. Roux-en-Y gastric bypass surgery (RYGBP) is more     effective than diet alone in producing long-term reduction of body weight. Yet even after     surgery there is a plateau in weight loss though the individual may still be obese and have     or be at risk for obesity related morbidities. The investigators have shown that plasma     leptin levels are significantly lower in women after RYGBP compared with BMI-matched     controls. This state of relative hypoleptinemia or leptin insufficiency suggests that     post-RYGBP individuals may be in a leptin-sensitive state and, thus, would undergo further     weight loss when administered doses of leptin that would not normally result in significant     weight reduction. This study will examine the effects of leptin administered by     self-injection twice per day on body weight and endocrine function. All individuals will     received leptin and placebo and different times during the 34 week study period.   "
218395|NCT00710827|"     To evaluate the safety and efficacy of Nebido compared to placebo in elderly men aged 50 and     over with symptomatic late onset hypogonadism   "
218402|NCT00710931|"     The objective of this study is to prospectively evaluate the visual parameters in a series of     patients after phacoemulsification cataract surgery in a series of patients bilaterally     implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).   "
218403|NCT00710944|"     The purpose of this study is to evaluate survival for ASTRA TECH Implant System, OsseoSpeed™     implants following immediate loading in extraction sockets versus immediate loading in healed     ridges. Patients in need of single standing implants replacing teeth in the maxilla within     zone 15-25 will be included and followed for 5 years. Primary objective is implant survival     rate at 12 months.   "
218404|NCT00710957|"     Projections from NHANES III indicate that approximately 12,000,000 U.S. adults ≥ 60 years of     age have vitamin D insufficiency (serum 25(OH)D < 50 nmol/L). A growing body of evidence     suggests that vitamin D status may be important in biologic processes involved in the     maintenance of physical function. To test the hypothesis that vitamin D insufficiency is     associated with poorer muscle strength and physical performance, we propose to evaluate the     role of vitamin D status (serum 25(OH)D) on physical function and falls in the CHS All Stars     cohort, a population of advanced age. The specific aims are as follows:      Specific Aim 1. To describe the prevalence and correlates of vitamin D insufficiency in     adults of advanced age.      Specific Aim 2. To examine the cross-sectional association between vitamin D status and     muscle strength (leg and grip strength), physical performance (3 m/15 ft walk time, repeated     chair stands, and standing balance), self-reported physical function (mobility, ADL and IADL     disability), and falls.      Specific Aim 3. To examine the longitudinal association between vitamin D status at baseline     and incident disability (mobility, ADL and IADL disability) over 3 years of follow-up.      Research Hypotheses: Low vitamin D status (25(OH)D < 50 nmol/L) will be associated with (a)     lower levels of muscle strength and physical performance; (b) higher levels of self-reported     limitations in physical function and falls; and (c) greater odds of incident disability.   "
218405|NCT00710970|"     The major objective of this two-stage phase II study is to determine whether tamoxifen is     deserving of further study in metastatic bladder cancer. Tamoxifen is expected to function as     a cytostatic (and not cytotoxic) agent, and may produce more disease stability than     regression. Sustained stable disease is considered to be clinically important and the more     likely event. Hence, 4-month freedom from progression is chosen as the primary end-point     instead of response rate. Freedom from progression is defined as the period from start of     therapy to the time of objective radiologic progression. A total of 25 subjects will be     enrolled, 15 during stage 1 and 10 during stage 2 of a two-stage minimax design phase II     study.      Pre-therapy evaluation (within 3 weeks of initiation of therapy):        -  History and physical examination (H and P)        -  Performance status (PS) assessment        -  CBC (complete blood counts)        -  CMP (complete metabolic profile)        -  Pregnancy test (in women younger than 50)        -  Computed tomography (CT) scan of the chest, abdomen and pelvis        -  Bone scan if bone pain or raised alkaline phosphatase        -  Biopsy (may use previous biopsy specimen)        -  Samples of plasma from the routine CBC and CMP will be banked indefinitely for future          biomarker studies at the Scott Department of Urology.      Treatment plan: Therapy will be administered as an outpatient. Tamoxifen is administered at     20 mg/day as a single daily oral dose. Clinical assessment of patients by a history and     physical examination will be performed every 4 weeks (one cycle). Objective radiological     assessment of response will be made every 8 weeks or earlier if clinically indicated. A CT     (computerized tomography) scan of the abdomen, pelvis and chest will be performed at baseline     and every 2 cycles. A response is confirmed by repeating the scans in 4 weeks. Bone scan is     performed if the patient complains of new bone pain or has raised alkaline phosphatase. A     radiologist who is blinded to the treatment regimen reads the scans. The RECIST criteria are     used to define response. Tamoxifen is continued until progressive disease or intolerable side     effects occur.   "
218406|NCT00710983|"     Our group has discovered that routine vaccinations in childhood may have non-specific and     sex-differential effects on overall mortality. The effects are so large that they may have     marked effects on overall mortality and seriously distort female-to-male mortality rates in     high-mortality settings. We recently experienced periods during which oral polio vaccine     (OPV) was lacking. Hence, some children did not get the recommended OPV at birth. We were     following all infants as a part of a vitamin A supplementation trial. Surprisingly, we     discovered that not receiving OPV was associated with significantly lower mortality in boys,     but not in girls. We bled a subgroup of the children. Receiving OPV at birth significantly     dampened the immunological response to BCG given at birth in both sexes. Based on these     observations, receiving OPV at birth may have two negative effects, first, it may increase     male mortality, and second, it may interfere with immunity against tuberculosis. OPV at birth     is given for logistic reasons, to boost polio immunity. There have been no polio cases in     Guinea-Bissau for the last 10 years. Hence, there is every reason to test in a randomised     trial whether not receiving OPV at birth is associated with 1) mortality, morbidity and     growth and 2) immunological response to BCG.   "
218407|NCT00710996|"     To determine what effect a blue light filtering Intraocular Lens (IOL) has on macular pigment     levels.   "
218408|NCT00711009|"     The purpose of this study is to compare the safety, tolerability, and antiviral activity of     the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase     inhibitors to lopinavir/ritonavir tablets when administered in combination with a human     immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1     infected subjects.   "
218410|NCT00711035|"     This trial is designed to evaluate the feasibility, safety and efficacy of most closely     HLA-matched multivirus specific CTL lines (CHM-CTLs) in HSCT patients with EBV, CMV or     adenovirus infections that are persistent despite standard therapy.      The primary objective of the study is to assess safety and feasibility of administering CTLs.     Survival data will be collected by asking the transplant center to submit the routine     Transplant Essential Data form that is sent to the Stem Cell Transplant Outcomes Database at     100 days and 1 year and includes data on survival status and other outcome measures.   "
218411|NCT00711048|"     The purpose of the study is to compare sensitivity and sensitization of visceral pain in the     esophagus using different pain stimuli   "
218412|NCT00711061|"     The purpose of this study is to compare the cardiovascular risks of growth hormone deficient     young adult males who have completed growth hormone therapy to healthy young adult males.   "
218413|NCT00711932|"     The goal of this study is to determine the apoptosis-inducing efficacy of TRA-8 in patient     ovarian cancer tissues using a tissue slice technology. In addition, we want to evaluate the     expression of apoptosis regulatory proteins using multiplex proteomic technology and its     correlation with TRA-8-induced cytotoxicity in patient ovarian cancer tissues.   "
218484|NCT00712855|"     The purpose of this study is to evaluate the safety and tolerability of escalating doses of     mapatumumab in combination with sorafenib in subjects with advanced Hepatocellular Carcinoma     who are positive for hepatitis B surface antigen or hepatitis C antibody.   "
218414|NCT00711945|"     Pediatric Crohn's Disease is a life long disease , presenting early in life.As such , it is     imperative to be able to evaluate the risk for more severe disease and poorer outcomes when     making the decision which therapies to offer our patients. These decisions should be based     according to longer-term disease outcomes, such as whether they prevent disease relapse or     prolong remission [10-12]. However, for the most part, previous studies were not designed to     yield predictive parameters that could allow a clinician to differentiate which patients are     at a higher risk for relapse, or more likely to to have serious attacks or complications of     the disease or therapy. The ability to predict these risks would impact dramatically the way     CD patients are treated, allowing the clinician to tailor therapy, both type and intensity,     to each patient's individual risk for relapse and outcomes.In the present first phase of the     study , we will attempt to identify factors that predict relapse of the disease, focusing on     the use of calprotectin at onset and after clinical remission, and on the use of anti-glycan     antibodies, as well as disease severity, site and phenotype.   "
218415|NCT00711958|"     This is a randomized, double-blind, multicenter clinical phase III study involving about 105     cancer patients aged >18 years who are receiving palliative chemotherapy and who are     suffering from chemotherapy associated anemia. A standard treatment group (ERYPO®) will be     included to provide a reference reflecting current standard medical practice.   "
218416|NCT00711971|"     This study is designed to test whether an alternative medicine treatment, fish oil, will     prevent depressive symptoms in pregnant and postpartum women who have been found to be at     risk for depression. Epidemiologists have observed that people who live in countries where     people on average eat a diet high in fish have a lower risk of depression than people who     live in populations that eat less fish. Postpartum depression is also less common in these     countries. The omega-3 fatty acids found in fish oil are thought to be responsible for this     beneficial effect of eating fish. The two major omega-3 fatty acids found in fish are     eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an essential building     block of the brain and nerve tissue. EPA may act to optimize the electrical signals between     nerve cells and brain cells and may help the immune system to function well.      Some researchers have treated people who are already suffering from depression with fish oil.     Some of these studies have shown a benefit for the fish oil treatment and others have not.     These studies have tested EPA and DHA alone and in various combinations. Currently, it is not     known whether EPA or DHA is more effective in preventing and treating depression. Some of the     researchers involved in this study have learned how to identify mothers who are most at risk     for developing depression during and after pregnancy. This study is designed to learn whether     EPA-rich and DHA-rich fish oil supplements will prevent depressive symptoms in women who are     at risk to develop depression.   "
218417|NCT00711984|"     Renal artery stenosis (RAS) usually refers to a disease of the large extra-renal arterial     vessels and most frequently is caused by atherosclerotic obstructions. The prevalence of     atherosclerotic RAS increases with age, male gender, traditional cardiovascular risk factors     (hypertension, diabetes, smoking, hyperlipidemia) and atherosclerotic comorbidities like     coronary artery or peripheral artery disease (PAD). A prevalence up to 40% has been reported     in patients with PAD. Undoubtedly, atherosclerotic RAS is a progressive disease, as more than     half of the patients exhibit an increasing degree of stenosis within five years after     diagnosis, and one out of five patients with a critical stenosis (>60%) suffers renal atrophy     and renal failure during this period. RAS may be treated conservatively by so called best     medical treatment, surgically, or by endovascular interventions using balloon angioplasty and     stenting.      The purpose of the investigators study is to determine the incidence and the predictors of     RAS in patients with PAD, and to compare the effect of renal artery stenting versus best     medical treatment in patients with hypertension and ostial renal artery stenosis in a     randomized controlled trial.   "
218418|NCT00711997|"     This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and     preliminary efficacy of DTA-H19 administered intratumorally in patients with unresectable,     locally advanced pancreatic cancer.      Primary Objective: The primary objective is to determine the maximum tolerated dose (MTD) of     intratumoral DTA-H19 and identify any dose limiting toxicities (DLTs).      Secondary objectives include determining the adverse events (AEs) profile, effects on     clinical laboratory analytes, vital signs, PK, tumor response, and possible tumor     resectability after 4 intratumoral administrations of DTA-H19.   "
218419|NCT00712010|"     The purpose of the clinical study is to investigate the effect of the protein quality of     high-protein meal replacements on the management of post-prandial blood glucose in healthy     men.   "
218420|NCT00712023|"     The purpose of this study is to determine whether a custom-made forced-air warming mattress     can prevent heat loss in patients undergoing vascular surgery better than a circulating-water     mattress   "
218422|NCT00712049|"     Dyslipidaemia is characterized by low plasma levels of high-density lipoprotein cholesterol     (HDL-c), elevated triglycerides and an increase in low density lipoprotein (LDL-c) particles,     and has been unequivocally established as a most important cardiovascular risk factor. While     statins are effective in reducing plasma levels of LDL-c, these drugs have only modest     effects on raising HDL-c (typically by less than 10%), even with aggressive statin therapy.     However, increasing evidence suggests that low HDL-c might be at least as relevant as high     LDL-c in promoting the development and progression of atherosclerosis. The beneficial effect     of raising HDL-c on clinical outcome has already been demonstrated by several studies.      Nicotinic acid is the most potent agent available for raising plasma levels of HDL-c by up to     29% at clinically recommended doses, and substantially lowers triglycerides and LDL-c.     Furthermore, nicotinic acid is also the most potent lipid lowering agent available that     reduces Lp(a), an independent marker of cardiovascular risk. In a recent study patients with     coronary artery disease had a 21% increase in HDL-c and a 13% decrease in triglycerides, and     these beneficial effects on lipid status may have contributed to a stabilization or     regression of carotid intima-media-thickness (IMT).The impact in patients with advanced     atherosclerosis like peripheral artery disease (PAD) in unknown.      The investigators hypothesized that nicotinic acid in addition to statin therapy may inhibit     progression of peripheral arterial atherosclerosis. Therefore, the aim of the present     randomized controlled trial is to investigate the effects of nicotinic acid (daily dose     starting with 500 mg, up to 2000mg) in addition to simvastatin (40 mg daily) versus     simvastatin (40mg daily) monotherapy in patients with low serum HDL-C levels and PAD with     respect to changes of carotid and femoral IMT, changes of patients´ lipid status and     occurrence of major adverse cardiovascular events (MACE).   "
218423|NCT00712062|"     The purpose of this study is to determine if pemetrexed is effective in the treatment of     primary central nervous system lymphoma (PCNSL) that has either worsened during treatment or     has returned after completing treatment.   "
218424|NCT00712075|"     Aging and psychosis are major priority areas for VA. This project is a continuation of a     Merit Review Program, in which we developed, manualized and conducted randomized controlled     trials of a novel psychosocial rehabilitation intervention for older people with     schizophrenia, called cognitive-behavioral social skills training (CBSST). We found that     CBSST improved community functioning in these patients. CBSST, however, is an intensive     program that would burden VA mental health clinics with demands for additional staff and     financial resources and burdens older veterans with travel and time demands. To reduce these     burdens and barriers to implementation of CBSST, we are developing a computer-assisted CBSST     intervention that takes advantage of available handheld computer technology. Therapist     contact is cut 50% and replaced by handheld computer-assisted CBSST intervention tools. The     project will examine whether computer-assisted CBSST is as effective as the full CBSST     program, while improving client satisfaction and reducing burden and cost.   "
218425|NCT00712088|"     This project will test the efficacy of a behavioral intervention to reduce sexual risk for     HIV infection among African American Men who Have Sex with Men (MSM).   "
218426|NCT00712101|"     The purpose of this study is to examine whether intracoronary abciximab bolus application     with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary     intervention is beneficial for patients with STEMI in comparison to standard i.v. bolus     application with respect to 90-day mortality, reinfarction and new congestive heart failure.   "
218427|NCT00712114|"     The purpose of this pilot, exploratory study is to evaluate the safety, tolerance,     pharmacokinetics and potential anti-inflammatory activity of an investigational agent,     HE3286, when administered orally for 29 days to patients with rheumatoid arthritis that are     taking a stable dose of methotrexate.   "
218428|NCT00712127|"     The purpose of this project is to establish a Center of Excellence in Research on Obesity     that will focus on severe obesity. The prevalence of severe obesity (i.e., Class 2 and 3     obesity; body mass index > 35 kg/m2 and 40 kg/m2) is increasing more rapidly than is     overweight and Class 1 obesity. Treatment guidelines for severe obesity are uncertain.      Three novel hypotheses regarding the pathogenesis of severe obesity will be tested: a) using     non-invasive methods to measure energy expenditure; b) conducting an annotated lipomic search     for bio-markers of impaired fat oxidation; and c) examining the role of obesity-induced     inflammation as a cause for leptin resistance. Responses will also be measured following     intervention with diet and activity.   "
218429|NCT00712140|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. It is not yet known which regimen     of trastuzumab is more effective in treating early breast cancer.      PURPOSE: This randomized phase III trial is comparing two trastuzumab regimens to see how     well they work in treating women with HER2-positive early breast cancer.   "
218430|NCT00712153|"     Coronary artery disease is a major cause of morbidity and mortality across the world and     coronary artery bypass surgery (CABG) is the most common surgical procedure for treatment.     Patients with recurrent ischemic symptoms after CABG are most likely to have occluded or     significantly stenosis in grafts or native coronary arteries. Therefore, there is a need to     evaluate the patency of these vessel conduits after CABG. Until now, selective coronary     angiography is the traditional gold standard for the assessment of both native coronary     arteries and bypass grafts. But it is an invasive procedure that requires x-ray exposure,     hospitalization, and includes a risk for complication. However, there is an alternative     noninvasive method, multislice computed tomography (MSCT), with high specificity and     excellent sensitivity for the detection of the coronary artery disease. It is even cheaper     and takes shorter time to perform. Accordingly, the purpose of this study is to use MSCT to     evaluate the patency and the quality of all grafts and native coronary arteries after CABG     for more than two years. In addition, we will elucidate the relationship of these data and     CABG procedures to review our experience.   "
218431|NCT00712166|"     The purpose of this study was to evaluate the safety and efficacy of a 28-day course of     aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung     disease (forced expiratory volume in 1 second [FEV1] >75% predicted, and Pseudomonas     aeruginosa (PA) infection.   "
218432|NCT00712179|"     This is a research study to understand how people who have experienced a stroke walk in order     to develop better and more effective types of therapy. Data collected from people who have     experienced a stroke and healthy individuals will be used to compare a neurologically healthy     person to someone, which has sustained an injury.   "
218456|NCT00712491|"     The purpose of this study is to determine the safety and efficacy of an ocular sirolimus     (rapamycin) formulation via different injection routes in patients with treatment-naive     sub-foveal choroidal neovascularization secondary to age-related macular degeneration.   "
220638|NCT00741325|"     This is a long-term observational study of patients that were treated with at least 1 dose of     study treatment (plerixafor or placebo) in the AMD3100-3101 protocol (NCT00103610).   "
218433|NCT00712192|"     Although the long saphenous vein remains the most commonly used conduit in coronary     revascularization, traditional open vein harvest may lead to significantly impaired wound     healing and post-operative pain. To this end, endoscopic saphenous vein harvesting techniques     have been shown to reduce post-operative morbidity. Studies have shown that endothelial     integrity and luminal nitric oxide synthase (NOS) are better preserved with novel no-touch     techniques; however, the effect and the associated mechanism of endoscopic vein harvest on     endothelial integrity and function remain unknown. Therefore, in the present proposal, we     will collect the saphenous vein segements immediately after harvesting, reperfusion, and     grafting, and then use enzyme-linked immunosorbant assay (ELISA), immunohistochemical     staining (IHC), and real-time polymerase chain reaction (RT-PCR) to detect the expression and     distribution of endothelial NOS (eNOS), endothelin-1 (ET-1), vascular cell adhesion     molecule-1 (VCAM-1), intracellular adhesion molecule-1 (ICAM-1), and platelet endothelial     cell adhesion molecule-1(PECAM-1) at protein and RNA levels in the endothelium of saphenous     veins. The major aim of this study is to elucidate the effect and mechanism of endoscopic     saphenous vein harvesting on endothelial properties as compare to conventional open vein     harvest technique.   "
218434|NCT00712205|"     The investigators want to test the hypothesis, that vitamin D3 improves pulmonary function     and quality of life in patients with asthma relatively resistant to glucocorticoids.   "
218435|NCT00712218|"     To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with     advanced ovarian cancer and intra-abdominal complete debulking.      Secondary: progression-free survival, complications and quality of life; Exploratory: Role of     number of resected lymph nodes for primary and secondary objectives   "
218485|NCT00712868|"     To demonstrate the safety and acceptability of the gynaecological formulation.   "
218436|NCT00712231|"     There have been numerous studies comparing various ACD measurements in phakic eyes,while     researches comparing ACD in pseudophakic eyes are less extensive. With the recent popularity     of presbyopia correction, measuring the ACD will facilitate differentiating pseudophakic     accommodation from pseudoaccommodation. It is thus mandatory to verify the accuracy of ACD     measurement of these devices since the innovation of various IOLs in the recent decade makes     this task more complicated. In this study, we will assess the limitations of using Pentacam     for ACD measurement in pseudophakic eyes and compare Pentacam measurement with IOLMaster and     A-scan measurements.   "
218437|NCT00712244|"     A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices     (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior     chamber space maintenance during non-eventful cataract surgery.   "
218438|NCT00712257|"     A Multicenter study to evaluation the safety and performance of Spectranetics Laser with     Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis   "
218439|NCT00712270|"     This study is being conducted to find a way to predict how individual schizophrenic patients     will respond if they are treated with different types of antipsychotic drugs. This could help     doctors prescribe the medication that will work best for each individual.   "
218440|NCT00712283|"     Determination of the ability to drive and operate machines after single and multiple oral     dose of Neramexane as compared to placebo   "
218441|NCT00712296|"     The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine     intervention (ASHMI) in adult asthmatics   "
218442|NCT00712309|"     1. Does primary stenting have a lower 12-month restenosis rate than PTA alone in the          treatment of atherosclerotic lesions of the popliteal artery?             -  Alternative hypothesis: Primary stenting with the Edwards LifeStent is associated               with a lower restenosis rate than PTA alone in patients with atherosclerotic               lesions of the popliteal artery at 12 months             -  Null hypothesis: Primary stenting with the Edwards LifeStent is not associated               with a lower 12-month restenosis rate than PTA alone in patients with               atherosclerotic lesions of the popliteal artery        2. Does comparison of the two intervention groups (PTA alone, stenting) disclose          differences in terms of the secondary endpoints?        3. How do the intervention methods compare in terms of safety/incidence of adverse effects?        4. What are the long-term clinical implications of the two treatment methods?   "
218443|NCT00712322|"     This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral     suspension in children, ages 2-15 years, with neurogenic detrusor overactivity. The results     will support a benefit-risk based dosage recommendation for phase IIIa clinical trials.   "
218444|NCT00712335|"     The purpose of this study is:        1. To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices          between smokers and non-smokers.        2. To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.   "
218445|NCT00712348|"     This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase     alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase     (Cerezyme®) enzyme replacement therapy.   "
218446|NCT00712361|"     1. Aim:           SoftTouch is a non-invasive device intending for use in the temporarily quantitative          measurement of peripheral blood biomarkers. The aim of the clinical trial is to study          the accuracy of the SoftTouch device compared with registered (FDA-approved) invasive          and non-invasive devices.        2. Hypothesis:      Human physiological biomarkers may be measured from the color distribution of the internal or     external (skin) tissue. The technology of the SoftTouch finger-mounted device is based on the     color distribution of the peripheral blood tissue, which enables the measurement of certain     biomarkers and vital signs under consideration.   "
218457|NCT00712504|"     This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib     malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be     tested in patients with advanced solid tumors, including non small cell lung cancer.   "
218458|NCT00712517|"     The study will test the hypothesis that patients anesthetized with propofol suffer less     postoperative pain than those anesthetized with sevoflurane.   "
218480|NCT00712803|"     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and     subtropical regions of the world. The purpose of this study is to evaluate the safety of and     immune response to a new dengue virus vaccine in healthy adults.   "
218447|NCT00712374|"     In areas of seasonal malaria transmission the burden of severe disease and mortality due to     malaria is mainly among children under 5 years of age. Intermittent preventive treatment     (IPT) with antimalarial drugs given to all children once a month during the transmission     season is a promising new strategy for malaria prevention. Studies in Senegal, Ghana, Mali     and The Gambia have shown this approach can be highly effective. In Senegal, seasonal IPT     with sulfadoxine-pyrimethamine (SP) and one dose of artesunate resulted in a 90% reduction in     incidence of clinical malaria in a recent trial in Senegal (Cisse et al., Lancet 2006). The     purpose of the present project is to determine the public health impact and cost     effectiveness of this intervention when it is delivered through the routine health service to     communities in rural areas in Senegal. Demographic surveillance will be set up in the rural     population of three districts (Mbour, Bambey and Fatick) which comprises approximately     540,000 people, including 100,000 children under 5 yrs, and is served by 54 health posts, as     an expansion of the area covered by the existing DSS of Niakhar. Information about births,     deaths and migrations, household characteristics such as socioeconomic status, and     vaccination status of children and their use of bednets, will be recorded in 6-monthly rounds     of all households. In selected areas, deaths among children under 10 years will be     investigated using verbal autopsies. Over four years from September 2008 - November 2011,     seasonal IPT (three monthly administrations of SP (sulfalene-pyrimethamine) plus amodiaquine     during the transmission season each year to children 3-59 months of age) will be introduced     gradually, in a step-wedge design, by 9 health posts in 2008, by an additional 18 posts in     2009, and another 18 in 2010 and 9 in 2011. At the end of each transmission season, a     cross-sectional survey of 2400 children under 5 yrs of age, in which finger prick blood     samples will be taken, will be used to estimate the prevalence of molecular markers of drug     resistance to Plasmodium falciparum, the prevalence of anaemia and the nutritional status of     children. Malaria incidence will be monitored by passive surveillance through health posts,     health centres, and hospitals. Cost effectiveness will be assessed. Due to changes in the     epidemiology of malaria in the study area, the upper age limit for inclusion was increased     from 5 to 10 years old from September 2009.   "
218448|NCT00712387|"     The hypothesis of this trial is to demonstrate that training junior surgeons on a virtual     reality (VR) simulator in addition to didactic teaching will improve their intraoperative     performance compared to those trainees who receive the traditional teaching paradigm (i.e,     operating under the guidance and instruction of a consultant general surgeon).      We anticipate that the VR trained group will make less critical intraoperative errors and     will perform faster than their traditionally trained colleagues.      Other study questions include:        1. Does objective assessment of fundamental abilities (FA) such as visuo-spatial ability          predict intra-operative performance?        2. Do FA predict rate of learning to reach proficiency?   "
218486|NCT00712881|"     Evaluate the efficacy and safety of treatment with MYOCET® in combination with     Cyclophosphamide and Trastuzumab, 4 cycles, followed by Docetaxel plus Trastuzumab, 4 cycles,     in women with stage II or III breast cancer whose tumour overexpresses the HER2 gene.   "
219928|NCT00731887|"     To examine long term physical and psychosocial outcomes of pediatric burn survivors. We want     to learn about thoughts, feelings, coping style, social support, and overall adjustment     following burn injury.   "
218449|NCT00712400|"     Latanoprost is a synthetic prodrug of 17-phenyl-substituted prostaglandin F2α analog. Used at     a dose of one drop per day, it has been reported to produce a 30 to 35% reduction in     intraocular pressure. Its mechanism of activation involves augmentation of the eye's natural     uveoscleral outflow capacity .      There is evidence that ocular blood flow plays a role in the clinical course of glaucoma.     Glaucoma medication that lowers IOP simultaneously increases ocular blood perfusion pressure,     which in turn may increase ocular blood flow.      This could well contribute to the partially contradicting results concerning ocular     hemodynamic effects of latanoprost. In vitro studies indicate that latanoprost has no effect     on ocular vascular tone in therapeutical doses. By contrast, it has been reported in several     studies that latanoprost 0.005% increases pulsatile ocular blood flow in patients with     primary open angle glaucoma and normal tension glaucoma. This increase in pulsatile ocular     blood flow mainly reflects an increase in the choroidal circulation.      Little is known about the potential effect of latanoprost on choroidal blood flow regulation     in humans. The present study therefore tries to elucidate whether treatment with latanoprost     may alter choroidal blood flow regulation during artificial changes in ocular perfusion     pressure. In addition, the present study aims to clarify whether the change in choroidal     blood flow after latanoprost administration are due to direct vasoactive effects or due to     the increase in ocular perfusion pressure. The second alternative may have important     implications on our understanding of glaucoma treatment, because reduction of IOP may then     per se result in normalization of ocular blood flow regulation.   "
218450|NCT00712413|"     The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera     approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given     twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will     receive Pylera treatment and omeprazole twice daily.   "
218451|NCT00712426|"     Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those     affected and their families. There are no treatments that slow the progression of HD, only     mildly effective symptomatic therapies are available.Creatine monohydrate is considered a     nutritional supplement. The purpose of CREST-E is to test whether high-dose creatine can slow     the progressive functional decline that occurs in persons 18 years or older with early     clinical features of HD. The long-term safety, tolerability and effectiveness of up to 40     grams daily creatine compared to placebo is studied. A variety of biological processes are     assessed for markers of disease activity or progression and creatine effects. Up to 50 active     research centers globally will enroll 650 subjects.   "
218452|NCT00712439|"     The purpose of this study is to determine whether a new Gabapentin tablet, is safe and     effective for the treatment of painful diabetic peripheral neuropathy.   "
218453|NCT00712452|"     The objective is to evaluate the influence of chemotherapy, either for auto-immune disease,     either for carcinologic disease, on clinical and biological markers of ovarian reserve, for     young patients, with normal reproductive functions.   "
218454|NCT00712465|"     The primary purpose of this study is to learn more about how digoxin is handled by the body,     i.e. absorption, distribution, metabolism and excretion, when administered alone and in     combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled     by the body when administered alone and in combination with digoxin and to learn more about     how AZD1305 and digoxin administered alone and in combination affect the body.   "
218455|NCT00712478|"     This study is conducted in Europe. The aim of this observational study is to determine     diabetes control improvement, during the third month of follow-up after insulin     intensification to at least 3 daily insulin injections, in assessing the proportion of     uncontrolled fasting and postprandial glycaemia values recorded on a diary.   "
218459|NCT00712530|"     -  DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered          topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir          migrate to lymph nodes and express HIV-like particles that induce immune responses to          kill HIV-infected cells.        -  Hypothesis: Single DermaVir immunization is safe and immunogenic measured by induction          of HIV-specific precursor/memory T cell responses.        -  GIHU004 was a phase I dose escalation study conducted in Hungary. It evaluated the          safety and immunogenicity of three dosing regimens of topical DermaVir immunization for          the treatment of HIV-infected individuals on fully suppressive highly active          antiretroviral therapy (HAART).   "
218460|NCT00712543|"     This study will evaluate whether patients have an overall preference for Kristalose® or     liquid lactulose based on taste, consistency, and portability.   "
218461|NCT00712556|"     RATIONALE: Diagnostic procedures, such as fluorine 18-fludeoxyglucose positron emission     tomography (PET) scans, may help doctors predict a patient's response to treatment and help     plan the best treatment.      PURPOSE: This phase I trial is studying fluorine 18-fludeoxyglucose PET scan to see how well     it predicts outcomes in patients who have undergone high-dose chemotherapy and autologous     stem cell transplant for non-Hodgkin lymphoma.   "
218462|NCT00712569|"     The purpose of this study is to learn about how patients who have looked up cancer-related     information on the internet talk with their doctors. We are interested in these conversations     even if the patients do not think they will talk about the information with their doctor     during their visit. We will audio record doctor-patient visits and listen to these recordings     to learn about how patients who have looked up cancer-related internet information talk to     their doctors and how their doctors talk to them. We will also give patients questionnaires     before and after their appointments to learn about what they think about communicating with     their doctors.   "
218463|NCT00712582|"     About 60% of patients with DLBCL can be cured with a chemotherapy program. It is called     RCHOP-21 (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). It is given     once every 3 weeks, for 18 weeks. Each three weeks is a cycle. Some factors predict that you     may not be cured with R-CHOP-21. The most common ones are:        -  Stage - how much DLBCL, PMBL, or FL3B you have        -  LDH - a blood chemistry marker; and        -  Whether you can do your normal daily activities. (performance status) We think that the          best way to cure more patients with poor risk factors is to add new treatment to R-CHOP.          You will get different chemotherapy after 4 cycles. This type of treatment is called          risk-adapted therapy.   "
218464|NCT00712595|"     The objectives of this study are to estimate the efficacy and safety of the daily     administration of mifepristone 5 mg versus 10 mg for three months for the treatment of     uterine fibroids.      The hypothesis of the study is that both mifepristone doses reduce the volume of the myoma in     about 40% after 3 months of treatment.   "
218465|NCT00712608|"     A study to evaluate the growth and development of term infants fed either a marketed cow's     milk formula, or an experimental cow's milk formula with prebiotics + a different calcium     source + a different level of fatty acids and fat, or an experimental cow's milk formula with     prebiotic + a different calcium source + a different level of fatty acids and fat   "
218466|NCT00712621|"     Rationale: Determining quality of life in breast cancer patient after completing chemotherapy     or radiation therapy or surgical procedures or any combination therapy.      Intervention includes supportive care in terms of psychological support and moral boosting     efforts by counseling breast cancer survivors which may enhance the well-being and quality of     life of women who are treated with chemotherapy or radiation therapy or surgical procedures     or any given combination therapy.      PURPOSE: Randomized clinical trial study to compare the effectiveness of support system and     counseling of breast cancer survivors on the well-being of women, who have completed various     modes of treatment of breast cancer with the subjects who have no support system.      Study Type: Quality of life and survival      Study Design: Two arm randomized controlled clinical trial to study quality of life and     survival of breast cancer patients after completion of chemotherapy or radiation therapy or     surgery or any combination therapy. The stages from I to IV (metastases to other sites of the     body) are included.   "
218467|NCT00712634|"     RATIONALE: Vaccines may help the body build an effective immune response against     cytomegalovirus.      PURPOSE: This randomized phase I trial is studying the side effects and best dose of     cytomegalovirus vaccine in healthy participants.   "
218468|NCT00712647|"     The Carotene and Retinol Efficacy Trial (CARET) was a randomized, double-blind,     placebo-controlled trial of the cancer prevention efficacy and safety of a daily combination     of 30 mg of beta-carotene and 25,000 IU of retinyl palmitate in 18,314 persons at high risk     for lung cancer. CARET began in 1985, and the intervention was halted in January 1996, 21     months ahead of schedule, with the twin conclusions for definitive evidence of no benefit and     substantial evidence of a harmful effect of the intervention on both lung cancer incidence     and total mortality. CARET continued to follow and collect endpoints on their participants     through 2005. During the active intervention phase of CARET, serum, plasma, whole blood, and     lung tissue specimens were collected on participants. These biospecimens make up the CARET     Biorepository.      The CARET Biorepository is a valuable resource for population-based studies of the major     human cancers. During CARET's twenty years of follow-up (1985-2005), we have received reports     of 1,445 participants with lung cancer, 901 with prostate cancer, 433 with breast cancer, 334     with bladder cancer, 332 with colon cancer, and 1,429 with other cancers. CARET is one of the     few trials that has prospectively collected serum, plasma, whole blood, blood spots (for     DNA), and lung cancer tumor specimens, as well as smoking history and serial food frequency     questionnaires (in some individuals for up to 12 years) in populations at high risk for lung     cancer. This wealth of information in over 18,000 individuals makes the CARET Biorepository a     special resource for cancer researchers.   "
218469|NCT00712660|"     Information Technology-aided Program of Relapse Prevention in Schizophrenia (ITAREPS) will     decrease the number of hospitalizations in patients with schizophrenia or schizoaffective     disorder who are treated in the outpatient psychiatric setting, as evidenced by the reduction     of the total number of hospitalizations due to relapse of psychosis at the end of the     12-months follow-up period in the active ITAREPS group compared to the control     (treatment-as-usual) group.   "
218470|NCT00712673|"     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in     comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of     treatment, followed by an extension.      The primary objective is to assess the effects of lixisenatide as an add-on treatment to     metformin in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.      The secondary objectives are to assess the effect of lixisenatide, in comparison to placebo,     when administered in the evening within 1 hour prior to the meal in terms of HbA1c reduction,     percentage of patients reaching HbA1c less than (<) 7 percent (%), percentage of patients     reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), plasma glucose,     plasma insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test     (only in morning injection arms), body weight, beta-cell function assessed by homeostasis     model assessment (HOMA)-beta, fasting plasma insulin (FPI) and adiponectin; to evaluate     safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development,     beta-cell function 4 weeks after study drug discontinuation (only in patients from the     morning injection arms in some selected centers).   "
218471|NCT00712686|"     The purpose of this study is to compare the efficacy and tolerability of aripiprazole to     olanzapine over 26 weeks for the treatment of schizophrenia   "
218472|NCT00712699|"     This study will evaluate the safety and effectiveness of extended release mixed amphetamine     salts in treating preschool children with attention deficit hyperactivity disorder.   "
218473|NCT00712712|"     RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to     remove bone metastases.      PURPOSE: This phase II trial is studying how well morphine works after radiofrequency     ablation of painful bone metastases in patients with cancer.   "
218474|NCT00712725|"     The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of     MK3207 in the treatment of acute migraine.   "
218475|NCT00712738|"     This study will determine if nifedipine, a medication used to treat high blood pressure, can     help treat iron overload, a condition in which the body contains too much iron. Iron overload     can be caused by the body's inability to regulate iron or by medical treatments, such as     multiple blood transfusions. Over time, it can cause problems with the liver, heart and     glands. Treatments include reducing iron intake in the diet or removing the excess iron using     medical therapies. Recently, nifedipine was found to cause iron loss in the urine of small     animals. This study will see if the drug can increase the removal of iron into the urine in     humans as well.      People 18 years of age and older with iron overload may be eligible for this study to undergo     the following procedures:      Study Day 1      Participants come to the NIH Clinical Center for a medical history, physical examination,     blood and urine tests, electrocardiogram (EKG) and echocardiogram (heart ultrasound).      Study Day 2      Participants will collect three urine samples: one is collected over 4 hours, followed by a     second over 4 hours. Both of these samples are collected at NIH in the outpatient day     hospital. At home, a third urine sample will be collected over 16 hours. For 1 week before     the collections, participants are asked not to drink tea or eat foods high in Vitamin C or     iron. They are also asked not to take any iron chelating medications.      Study Day 3      Participants repeat the same urine collections as on day 2. They collect a 4-hour urine     sample at the outpatient day hospital at NIH. They will then take a 20-mg tablet of     nifedipine, and remain in the clinic 4 hours for blood pressure monitoring. A second urine     sample during this time. They then return home to collect the final 16-hour sample, which     they bring to the clinic the following day. Again, they are instructed to avoid a diet high     in vitamin C, iron rich foods, tea, and to avoid taking any iron chelating medications.   "
218476|NCT00712751|"     We know that treatment for rectal, colorectal or anal cancer can impact sexual function. This     study aims to learn:        -  How the treatment affects emotional and social well-being.        -  How a new sexual health educational program affects you.      Cancer patients seek education for lots of reasons. It often helps them cope because they can     express their feelings with a trained professional. This study is open to individuals who     have been treated for rectal, colorectal or anal cancer. It involves a new type of sexual     health counseling program. It will teach participants skills that they can use to improve     their sex lives. These skills may also improve physical and emotional well-being. We will     compare the new type of sexual health program with the standard care patients receive after     treatment for rectal, colorectal or anal cancer.   "
218477|NCT00712764|"     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in     perfusion pressure. For a long time it had been assumed that the choroid is a strictly     passive vascular bed, which shows no autoregulation. However, recently several groups have     identified some autoregulatory capacity of the human choroid. In the brain and the retina the     mechanism behind autoregulation is most likely linked to changes in transmural pressure. In     this model arterioles change their vascular tone depending on the pressure inside the vessel     and outside the vessel. In the choroid, several observations argue against a direct     involvement of arterioles. However, the mechanism behind choroidal autoregulation remains     unclear. Adenosine, an endogenous purine metabolic end product with a potent vasodilatory     effect on multiple vascular beds, leads to an increase in retinal and choroidal vessel     diameter. The present study aims to investigate whether adenosine plays a role in choroidal     autoregulation during a decrease in ocular perfusion pressure, which will be achieved by an     increase in intraocular pressure.      Pressure/flow relationships will be investigated in the absence and presence of adenosine.   "
218478|NCT00712777|"     Topical brimonidine is a recently introduced alpha 2 receptor agonist which is used in the     therapy of intraocular pressure (IOP) reduction in patients with open angle glaucoma.     Although adequate IOP reduction is achieved in many patients there is a considerable degree     of variability in IOP reduction among subjects. The reason for this interindividual     variability is not entirely clear. Obviously differences in pharmacokinetic properties due to     variable penetration of the drug through the cornea may be responsible. Alternatively,     polymorphisms of the alpha-2 receptor may account for the differences in IOP-lowering     efficacy of topical brimonidine. This hypothesis is tested in the present study.     Polymorphisms of the alpha-2 receptor have been described in a number of previous studies. In     addition, polymorphisms in the alpha-2 receptor gene have been shown to be functionally     important, particularly a polymorphism of the alpha-2B receptor, which has a high allele     frequency in caucasians.   "
218479|NCT00712790|"     This Phase I/II trial will evaluate the safety and activity of chemo-radiotherapy comprising     a regimen of Sorafenib chemotherapy plus SIR-Spheres yttrium-90 microspheres     (chemo-radiotherapy, also known as chemo-SIRT), for first-line treatment of patients with     primary hepatocellular carcinoma (HCC) in whom surgical resection is not feasible.      This study is designed as a prelude to a planned future randomised comparative study that     will compare the efficacy of Sorafenib plus SIR-Spheres versus Sorafenib alone, in this     patient population.   "
221622|NCT00751608|"     This study will evaluate the effect of APL180 on endothelial function measured by forearm     venous occlusion plethysmography in patients with familial hypercholesterolemia.   "
218482|NCT00712829|"     This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly     administered a single 10.0 mCi dose of 123I-MIP-1072 or 123I-MIP-1095 (study drugs). The     second (alternate) study drug will be administered approximately 14 days after the first. A     final follow-up visit will occur approximately 2 weeks after the injection of the alternate     study drug.   "
218483|NCT00712842|"     A variety of studies demonstrate that ocular blood flow is altered in diabetes and retinal     perfusion abnormalities have been proposed to contribute to the pathogenesis of diabetic     retinopathy.      Various animal and human studies have demonstrated that retinal and optic nerve blood flow     increase in response to diffuse luminance flicker. Based on studies with ERG, this effect has     been attributed to augmented activity in the retinal ganglion cells and associated axons     indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a     variety of studies describe the effects of flickering light on retinal and optic nerve head     blood flow, the knowledge about this coupling in the diabetic retina is sparse.      In view of the fact that neural activity and blood flow are strongly coupled in the human     retina, one could hypothesize that neurodegenerative changes in the retina could contribute     to the vascular dysregulation and in turn lead to changes of ocular perfusion. The     investigators set out to investigate whether the coupling of neural activity and blood flow     is impaired in patients with early stage diabetic retinopathy compared to those in healthy     volunteers.   "
219930|NCT00731913|"     To better understand surgeon preference when using synthetic, absorbable, monofilament suture     by comparing two similar appearing FDA-approved sutures, Monosyn (Aesculap) and Monocryl     (Ethicon).   "
218487|NCT00712894|"     The purpose of this study is to evaluate the efficacy of three different vasodilators     including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during     direct percutaneous coronary intervention for acute myocardial infarction.   "
218488|NCT00712907|"     High arterial blood oxygen tension leads to vasoconstriction of retinal vessels, possibly     related to an interaction between reactive oxygen species and endothelium-derived vasoactive     factors. Vitamin C is a potent antioxidant capable of reversing endothelial dysfunction due     to increased oxidant stress. Vitamin C appears to have vasodilatory properties, but the     underlying mechanisms are not well understood.      In the present study we hypothesized that hyperoxic vasoconstriction of retinal vessels could     be diminished by vitamin C.      Ocular blood flow will be determined by non-invasive methods, including laser Doppler     velocimetry and the Zeiss retinal vessel analyser.   "
218489|NCT00712920|"     The purpose of this study is to determine if two allergy medications are more effective than     placebo.   "
218490|NCT00712933|"     This is a long-term continuation study to provide continuing treatment to subjects with SLE.   "
218491|NCT00712946|"     The goal of this study is to evaluate the possible preoperative predictive value of altered     heart rate variability (HRV) and baroreflex sensitivity in different sleep stages for     postoperative adverse cardiac events (i.e. arrhythmia or myocardial ischemia needing     hospitalization or medication, myocardial ischemia assessed by enzyme release, myocardial     infarction, sudden cardiac death, stroke) in arteriosclerosis obliterans patients.   "
218492|NCT00712959|"     The purpose of this study is to collect additional immunogenicity and safety data on     re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health     need to establish broader population immunity against pertussis, as well as diphtheria and     tetanus.      Primary Objective:        -  To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.   "
218493|NCT00712972|"     The goal of our study is to present important anatomic considerations which should be     considered before knee injection is performed. Additionally, we have developed important     procedural augments to the traditional para-patellar injection techniques in order to exceed     the accuracy and safety previously reported for the infra-patellar approaches We have     developed an injection technique which mechanically is similar to current techniques     practiced and poses no additional risks or discomfort to the patient. The basis of our     technique and its success is through recognition of anatomic factors and avoidance of     possible iatrogenic injuries which exist when using other knee injection technique. The focus     of our study is to validate the clinical accuracy we have been obtaining using our technique     through fluoroscopically confirmed visualized confirmation of repeated intra-articular     deposit. Additionally we want to document the range of needle length we require to properly     access the knee joint in our population to substantiate the importance of needle length.     Needle length is a critical factor in obese patients whom have larger infra-patellar fat     pads.      Our hypothesis is that when using a 6 inch 22 gage needle for intra-articular knee injections     through the medial joint line approach, while utilizing the medial wall of the lateral     femoral condyle as an intra-articular stop point for needle insertion, the accuracy of     intra-articular deposit will exceed the values currently reported in the literature which is     approximately 75% success rate.      To prove this point we will be injecting 2 cc of radiocontrast dye into the joint space and     than immediatly view the joint flouroscopicly after the knee has been brought through 10     cycles of flexion and extension.   "
218494|NCT00712985|"     The purpose of this research is to establish if a once a year dose of Zoledronic Acid is     sufficient to suppress and maintain urine and serum bone density markers (NTx) and serum CTx     within normal range at 12 months post-dosing in postmenopausal early breast cancer patients     receiving additional treatment with non-steroidal aromatase inhibitors.   "
218505|NCT00713128|"     This is a study to determine how much nausea and or vomiting is caused by irinotecan-based     chemotherapy in patients with colorectal cancer. Patients with colorectal cancer scheduled to     receive their first cycle of an irinotecan-based chemotherapy regimen are eligible. Any     chemotherapy agents administered in combination with irinotecan must have low-minimal     potential to cause nausea and or vomiting. Examples of acceptable regimens would be     irinotecan in combination with infusional fluorouracil and leucovorin (FOLFRI) with or     without bevacizumab and irinotecan in combination with cetuximab. Patients who have received     prior non-irinotecan-based chemotherapy are eligible providing they experienced no vomiting     and no greater than mild nausea with their prior chemotherapy.   "
218519|NCT00713310|"     The overall objective of this study is to assess the safety and efficacy of high dose and low     dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks     to children and adolescents with mildly-to-moderately active ulcerative colitis.   "
218495|NCT00712998|"     The clinically widely used X-ray computed tomography examination has a low-grade radiation     effect and recently has attracted much attention concerning the possible adverse effects of     radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells     mainly because it can interact with water (which makes up to 80% of cells) to generate     reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we     can reach, there is no report concerning the relation between X-ray computed tomography     examination and the blood ROS concentration. Therefore, we wish to conduct this study to     clarify if the routinely applied X-ray computed tomography examination may induce a higher     concentration of ROS in the peripheral blood.      Study subjects will be participants of health check program at our hospital. The only     enrollment condition will be a scheduled X-ray computed tomography examination for either     lung (20 cases) or heart (20 cases) of the study subject. Another 20 participants receiving     health check program without X-ray computed tomography examination will be included as the     control group. The formal consent will be delivered to the participants of health check     program several days before their admission for health check and will be retrieved before the     proceeding of health check.      Measurements and comparison of ROS concentration will be performed in the sampled peripheral     blood before and after the performance of X-ray computed tomography examination during a     regular health check program. Totally 120 blood samples will be collected from included 60     study subjects within 3 months. Reactive oxygen species（ROS）levels will be measured by a     chemiluminescence (CL) analysing system (CLD-110, Tohoku Electronic Industrial, Sendai,     Japan).   "
218496|NCT00713011|"     The study consists of a 12 week run-in period when all subjects are stabilized on a single     dose of Avalide (300 mg/12.5 mg or 300mg/25mg dose) per day. After this 12 week run-in ends,     subjects will be randomly assigned to start the addition of either Adalat XL or Tiazac XC for     18 weeks of treatment. Subjects will have a 1 in 2 chance of receiving the study drug Adalat     XL and a 1 in 2 chance of receiving the drug Tiazac XC. An end of treatment visit will be     done 18 weeks after start of study drug. The expected duration of the study is 30 weeks. The     purpose of this study is to compare the change in proteinuria, through a urine test, while     taking study drug until high blood pressure (BP) is reduced to near normal levels in study     subjects with diabetic nephropathy and hypertension.   "
218573|NCT00714025|"     An open-label, single arm, non-randomized, single stage phase II study. 3 phases:Baseline,     treatment/duration and Follow-up. All patients will be treated with RAD001 10 mg daily dose     until disease progression or unacceptable toxicity death, or discontinuation from the study,     for any other reason   "
218497|NCT00713024|"     Patients with neuropathic pain exhibit hyperalgesia and allodynia. Although both peripheral     and central determinants are recognized for the pathophysiological basis of neuropathic pain     following peripheral injury, the modulating effect on pain processing in brain by peripheral     mechanisms remains elusive. Here, we will systematically compare the sensory symptoms and     brain activation to innocuous and noxious thermal stimulation applied to the distal leg, foot     dorsum or forearm between patients with peripheral neuropathy and healthy controls.     Functional magnetic resonance imaging will be used to define brain activation to somatic     stimulation with noxious and innocuous stimuli. The blood-oxygenation-level-dependent signals     will be correlated with visual analogue scale scores and sensory and affective components     obtained from the Short-Form McGill Pain Questionnaire. Brain activation during thermal     stimulation in patients with neuropathic pain will be clarified, and we will also analyze the     potential relationships between the topography, quality and intensity of the different     painful symptoms (i.e. spontaneous ongoing pain, paroxysmal pain, allodynia, hyperalgesia)     and the magnitude and pattern of brain activation during thermal stimulation. This will add     in our understanding in the pathophysiology of brain modulation in pain and provide     clinically useful message toward the potential therapeutics in the management of neuropathic     pain.   "
218498|NCT00713037|"     Before radiation treatment is given to treat chordomas, CT and MRI scans are used to create a     three dimensional picture of the tumor using x-rays. The CT and MRI scans are used to     determine the size and location of the area that will receive radiation treatment. The     purpose of this research study is to see if combining the images from the FMISO-PET scan and     the CT and MRI scans in radiation treatment planning changes the size and location of the     area that will receive radiation treatment when compared to planning the radiation treatment     with CT and MRI scans alone.   "
218499|NCT00713050|"     Our overall goal is to advance the state of functional brain imaging in aphasia, and then to     apply the method to an intensive, imitation-based treatment for non-fluent aphasia.   "
218500|NCT00713063|"     The purpose of this study is to test the effect of a moderate-intensity aerobic exercise     intervention for smokers interested in quitting smoking. We expect that this project will     contribute much needed knowledge about the role of aerobic exercise in smoking cessation. If     the efficacy of moderate-intensity, aerobic exercise for smoking can be established, smokers     may have a valuable adjunct to more traditional smoking cessation approaches.   "
218501|NCT00713076|"     Measure wettability of hydrogel and silicone hydrogel contact lenses presoaked in a     Multi-Purpose Solution.   "
218502|NCT00713089|"     This study aims to document prospectively the incidence of allergies of eczema, asthma and     allergic rhinitis in 2 diverse cohorts (Singaporean and Indonesian) with contrasting     lifestyles and socioeconomic development. The profile of microbial colonization in terms of     species variety, as well as their genetic diversity will be studied in Singapore and     Indonesia cohorts and to correlate these with clinical allergy.   "
218503|NCT00713102|"     The goal of this retrospective study is to describe emergency relevant illnesses occurring in     airline passengers.   "
218504|NCT00713115|"     The study is a prospective radonmized comparison between needlescopic adrenalectomy and     conventional laparoscopic adrenalectomy for benign adrenal tumors less than 5 cm. The     operative success rate, operative time, intraoperative blood loss, intraoperative or     postoperative complication, postoperative pain, postoperative hospital stay, convalescence,     and wound cosmesis were compared.   "
218518|NCT00713297|"     The objective of this prospective study is to build a real-time interactive platform where     doctors and pharmacists may communicate and solve patients' drug-related problems (DRP)     immediately and document accordingly. This study will also design a computerized physician     order entry (CPOE) system utilizing default protocol for chemotherapy order entry.   "
218506|NCT00713141|"     Primary Objective        -  To investigate and clearly document the presence and extent of cognitive decline, if          any, in women of Asian origin following standard-dose systematic adjuvant chemotherapy          for the treatment of breast cancer        -  Investigation and establishment of a relationship between degree of oxidative DNA and          lipid damage as indicated by plasma and urinary biochemical markers.      Secondary Objective      • To validate the use of hydrogen peroxide and serum amyloid as biomarkers of damage   "
218507|NCT00713154|"     The purpose of this study is to determine if MTS-01 is effective in preventing     radiotherapy-induced hair loss in patients receiving whole brain radiotherapy   "
218508|NCT00713167|"     Antioxidants are potent scavengers of free radicals and serve as inhibitors of neoplastic     processes. A large number of synthetic and natural antioxidants are known to induce     beneficial effects on human health and disease prevention. Cardioprotective ability of grape     seed extract polyphenols (GSEP) was studied in animals and humans. It has been suggested that     grape seed proanthocyanidins have cardioprotective effects against reperfusion-induced injury     of free radicals after ischemia. In another study, it is suggested that proanthocyanidins,     the major polyphenols in red wine, might trap reactive oxygen species in aqueous series such     as plasma and interstitial fluid of the arterial wall; thereby inhibiting oxidation of     low-density lipoprotein (LDL) and showing an antiatherosclerotic activity. The only human     model study designed to evaluate the effect of a standardized formulation of a GSEP     (leucoselect-phytosome [LP]) on the susceptibility of LDL to oxidation in a group of heavy     smokers, revealed that the antioxidant potential of GSEP may be effective in oxidative stress     (smoking); however more investigational data are needed before wider use in clinical     settings. Based on these observations, the investigators decided to evaluate the effect of     GSEP in reducing OX-LDL in patients diagnosed with mild hyperlipidemia.   "
218574|NCT00714038|"     Quality Improvement in Primary Care: delegation of check-ups to nurses in general practice   "
218575|NCT00714051|"     The purpose of this study is to test the effectiveness of a fall prevention program for older     adults. Participants assigned to the intervention group will train weekly on a special     treadmill that will simulate tripping. Patients not assigned to the tripping program will     walk on a standard treadmill.   "
218509|NCT00713180|"     The aim of the study is to find out why pterygium occurs and recurs in a rural African     population. Participants will be interviewed on personal and lifestyle information, family     history of pterygium, environmental exposure and history of previous eye inflammation. They     will undergo eye examination and photography. Those with pterygium will be operated on to     remove pterygium and followed up to detect any recurrence and complications of surgery. The     excised pterygium will be examined pathologically and genetically; participant's blood will     also be examined genetically. Data will be analyzed for statistically significant differences     in findings between pterygium and pterygium free participants.      The study hypothesis is that multiple factors are responsible for the occurrence and     recurrence of pterygium in a rural african population.   "
218510|NCT00713193|"     This research involves the use of immune base therapy as an adjunct to plasma exchange, the     present standard of care for thrombotic thrombocytopenic purpura (TTP). Funding source -FDA     OOPD   "
218511|NCT00713206|"     This prospective, randomized-controlled, clinical study evaluates the ability of the NanoTite     implant system to achieve integration and provide long-term support of a prosthesis when     placed immediately in fresh sinus augmentation material. Control cases will be those where     the sinus augmentation material is allowed four months of healing prior to NanoTite implant     placement. In addition to implant performance, radiographic evidence of crestal bone     regressive modeling will be used to evaluate differences between test and control cases.      Study (null) hypothesis: The implants placed into sinus augmentation sites at the time of     grafting will have the same integration success and maintenance of integration as for the     implants placed after four months of graft healing.   "
218512|NCT00713219|"     This is a study for patients who have head and neck cancer that has recurred in the body area     where they previously received radiation, and for whom surgery is not planned. A widely     accepted treatment option in this situation is chemotherapy alone. Another approach that has     been used in clinical trials is to treat patients with a repeat course of radiation. In these     studies, some patients received chemotherapy at the same time as the radiation.      In this clinical study, we wish to treat with radiation plus two drugs during the course of     reirradiation, Taxotere® (docetaxel) and Erbitux® (cetuximab). Docetaxel and cetuximab both     are chemotherapy drugs which are administered by vein. Both drugs help radiation kill cancer     cells.      The radiation will be administered using a strategy called intensity-modulated radiation     therapy (IMRT), which focuses the radiation beam on the tumor.      Docetaxel and cetuximab are both approved for the treatment of patients with head and neck     cancer.      However, the combination of radiation + docetaxel + cetuximab for patients with recurrent     head and neck cancer is considered to be a topic for clinical research. The purpose of this     study is to determine the good and bad effects of treatment with radiation + docetaxel +     cetuximab.   "
218513|NCT00713232|"     We will construct a Chinese Picture Naming test which include 60 items with various word     frequency and familiarity and is arranged by their familiarity in daily life.      Then we will collect the normative data for this test using normal subjects of various age     and educational level.   "
218514|NCT00713245|"     This study is to observe the progression of disease in late-onset Pompe disease   "
218515|NCT00713258|"     The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in     reducing back pain intensity over a 24-week treatment period in postmenopausal women with an     osteoporosis related vertebral fracture(s).      Secondly the objectives are to investigate any differences in patient reported outcomes     between the two treatment arms over a 24-week treatment period in postmenopausal women with     an osteoporosis related vertebral fracture(s).   "
218516|NCT00713271|"     The purpose of this study is to investigate the safety and tolerability of multiple once     daily ascending doses of AZD3199 in healthy men   "
218517|NCT00713284|"     The purpose of this study is to determine whether the combination of Myfortic and sirolimus     is effective at preventing rejection while preserving kidney function in stable kidney     transplant recipients.   "
218520|NCT00713323|"     The purpose of this study is to assess the safety and tolerability of long term therapy with     Sativex® in relieving neuropathic pain.   "
218523|NCT00713362|"     We hypothesize that VATS is more effective than CTD for management of primary spontaneous     pneumothorax with aspiration failure. To this end, we will compare two groups of patients who     had experienced unsuccessful aspiration of primary spontaneous pneumothorax stratified by     treatment.   "
218524|NCT00713375|"     Dysregulation of autonomic nervous system is evident in patients with spontaneous     intracranial hemorrhage. In this study, we utilize a non-invasive method (heart rate and     blood pressure variability analysis to analyze the autonomic activities in this group of     neurosurgical patients. Our aim is to determine the utility of this modality in risk     stratification and outcome prediction in these patients.   "
218525|NCT00713401|"     Assess the tolerability and safety of a rapid bolus of tecadenoson at different dose levels     when given alone and in combination with a beta-blocker (esmolol) in patients with atrial     fibrillation to control rapid heart rate. Explore the pharmacokinetic and pharmacodynamic     effects when given alone and in combination with beta-blocker (esmolol).   "
219050|NCT00711568|"     The purpose of this study is to determine whether repetitive high field transcranial magnetic     stimulation of the left or right frontal lobes is beneficial for the treatment of depression     that is refractory to antidepressant medication.   "
218526|NCT00713414|"     This study will examine how the brain controls speech in patients with spasmodic dysphonia, a     voice disorder that involves involuntary spasms of muscles in the larynx (voice box), causing     breaks in speech. Although the causes of spasmodic dysphonia are unknown, recent studies     found changes in brain function in patients with the disorder that may play a role in its     development.      People between 21 and 80 years of age with adductor spasmodic dysphonia may be eligible for     this study. Candidates are screened with the following procedures:      Medical history and physical examination.      Nasolaryngoscopy to examine the larynx. For this test, the inside of the subject s nose is     sprayed with a decongestant and a small, flexible tube called a nasolaryngoscope is passed     through the nose to the back of the throat to allow examination of the larynx. The subject     may be asked to talk, sing, whistle and say prolonged vowels during the procedure. The     nasolaryngoscope is connected to a camera that records the movement of the vocal cords during     these tasks.      Voice and speech recording to measure the type and severity of voice disorder. Subjects are     asked questions about their voice disorder and their voice is recorded while they repeat     sentences and sounds.      Participants undergo positron emission tomography (PET) and magnetic resonance imaging (MRI)     of the brain, as follows:      PET: A catheter is placed in a vein in the subject s arm to inject a radioactive substance     called a tracer that is detected by the PET scanner and provides information on brain     function. [11C]flumazenil is used in one scanning session and [11C]raclopride is used in     another. For the scan, the subject lies on a bed that slides in and out of the     doughnut-shaped scanner, wearing a custom-molded mask to support the head and prevent it from     moving during the scan. For the first scan the subject lies quietly for 60 minutes. For the     second scan, the subject lies quietly for 50 minutes and is then asked to say sentences     during another 50 minutes. The amount of radiation received in this study equals to a uniform     whole-body exposure of 0.9 rem, which is within the dose guideline established by the NIH     Radiation Safety Committee for research subjects. The guideline is an effective dose of 5 rem     received per year.      MRI: This procedure uses a strong magnetic field and radio waves instead of X-rays to obtain     images of the brain. The subject lies on a table that slides into the scanner, a narrow metal     cylinder, wearing ear plugs to muffle loud knocking sounds that occur during the scan. Images     of the brain structure are obtained while the subject lies still in the machine for 10     minutes. This is followed by functional MRI (fMRI) for 60 minutes, in which pictures are     taken while the subject speaks, showing changes in brain regions that are involved in speech     production.   "
218527|NCT00713427|"     This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to     collect data to support regulatory clearance by the FDA in the United States and to determine     the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment     for malignant bile duct obstruction.   "
218528|NCT00713440|"     The purpose of this study is to evaluate whether the reduced incretin effect and the     paradoxical glucagon responses during oral glucose ingestion and isoglycaemic iv glucose     infusion observed in patients with type 2 diabetes are causes (non-inducible in lean healthy     subjects without family history of diabetes) or consequences (inducible) of the diabetic     state.   "
218529|NCT00713453|"     This study is to study the response of muscle cells from Pompe disease after enzyme     replacement therapy   "
218530|NCT00713466|"     The purpose of this study is to determine if utilizing CLIPP (Computer-Assisted Learning     Pediatrics Program) cases in the pediatric clerkship will standardize students' exposure to     essential pediatric conditions and enhance their learning experience.   "
218531|NCT00713479|"     More people worldwide use amphetamine-type stimulants than any illicit drug besides cannabis,     and methamphetamine (MA) abuse and dependence is the fastest growing drug problem in the     United States. Much work remains in identifying an effective pharmacotherapy for MA     dependence. The neurobiological actions produced by MA involve dopamine (DA), serotonin, and     norepinephrine, but also include alterations to cholinergic neurotransmitter systems.     Candidate compounds that target acetylcholine (ACh) are attractive options for development     that have not received adequate attention. Varenicline is a drug that increases the release     of DA in the brain and it is logical to assume that it would to some extent compensate for     the reduction in these neurotransmitters that occurs in MA withdrawal.      Current research has linked certain genes that are related to neurotransmitters with drug     abuse and memory impairment (e.g., A1 allele for the D2 dopamine receptor and     catechol-O-methyltransferase). We will take blood samples and test for these genes in order     to relate the findings to brain function.      This is a double-blind, placebo-controlled, within-subjects study to determine the safety and     tolerability of MA in MA-dependent volunteers treated with varenicline and placebo.   "
218532|NCT00713492|"     This study will test the reliability of a procedure for self-administering ethanol (alcohol)     intravenously (through a vein), using a computer-assisted method. People ordinarily     self-administer alcohol through drinking alcoholic beverages, but blood alcohol levels     resulting from drinking vary greatly among individuals. For research on alcohol dependence     and treatment, a tool for achieving precise blood levels is needed. In addition to testing     this method of alcohol administration, the study will examine self-administration behavior     and resulting breath alcohol concentration, the effects of alcohol on the participants, and     differences between men and women in alcohol self-administration.      Healthy normal volunteers between 21 and 45 years of age may be eligible for this study.     Participants are assigned to one of two study groups. Group 1 undergoes three 7-hour study     sessions and group 2 participates in two sessions, each of which includes the following     procedures:        -  Breathalyzer and urine tests for alcohol and illicit drug use.        -  Urine pregnancy test for women.        -  Light lunch.        -  Questionnaire about health and recent drinking.      Alcohol infusion: Subjects are seated in a comfortable chair and instructed on how to use a     computer to give themselves a short infusion of alcohol through a catheter (plastic tube)     that has been inserted into a vein in their the arm. Sensors are placed on their chest to     monitor heart beat and their neck to record skin blood flow. At the start of the session,     subjects complete questionnaires about any drug effects and urges to drink they may be     feeling. They are trained on how to use the computer to administer alcohol and are then     allowed to self-administer alcohol through the catheter any time they like, as long as their     peak breath alcohol level does not exceed 0.1 g% (a level that would result from ingestion of     4 to 6 drinks in most people). If that point is reached, the computer automatically     inactivates self-administration until the level is lowered again. Breathalyzer readings are     taken every 15 to 30 minutes. Subjects may read, watch television or videos or listen to     music during the sessions.      Recovery: At the end of the 2.5 hours of self-administration, the catheter is removed and     subjects can eat, read, watch television and relax in the clinic until their breath alcohol     level falls below 0.02 g%, usually after 2.5 to 3 hours, when they can go home by taxi or     with a pre-arranged designated driver.   "
218533|NCT00713505|"     RATIONALE: An educational and skills training program for the parent of a childhood cancer     survivor with neurobehavioral dysfunction may help improve the child's school performance,     thinking ability, and behavior.      PURPOSE: This randomized clinical trial is studying an educational and skills training     program for parents of childhood cancer survivors who have neurobehavioral dysfunction.   "
218534|NCT00713518|"     The aim of the study is to evaluate whether PF-04523655 is effective in the treatment of     neovascular/wet AMD and at which dose.   "
218535|NCT00713531|"     The purpose of this study is to assess populations in Thailand at high risk for HIV-1     infection for potential efficacy trials of candidate HIV vaccines to include:        1. assess incidence of HIV-1 and volunteer retention        2. describe early viral load and CD4 counts        3. assess participant willingness to participate in HIV vaccine efficacy trials and other          HIV prevention trials        4. describe volunteer risk behavior   "
218622|NCT00705939|"     Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the     human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme     glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in     the cells of the monocyte-macrophage system.      This is an extension trial to Study NCT00376168 and NCT00712348.   "
218623|NCT00705952|"     The purpose of the study is to assess whether weight loss achieved through a programme of     intensive lifestyle management can result in enhanced production of Glucagon-Like Peptide-1     (GLP-1) together with improvements in the release of insulin and glucagon and thus     improvements in glycaemic control (HbA1c), in patients with new onset type 2 diabetes.      This is a cohort study with comparisons made between assessments at baseline, after an     initial four months of intensive intervention and after a further four months follow up     (maintenance period). Each patient will participate in the study for 8 month. The entire     study period will be 24 months.      All patients with new onset type 2 diabetes (within 2 weeks of diagnosis) will be recruited     from those referred to the Type 2 Diabetes Education Programme in the community (FOCUS), as     per standard practice. The investigators will also hope to recruit direct from local GP     surgeries who will be advised of the study. At this point, patients will be given a study     information sheet with a contact number if they wish to participate in the study.      Individuals who are unable to give consent, who would be unable to attend all the programme     sessions for medical or other reasons, who are prescribed oral hypoglycaemic, antiobesity or     any other prescription medications that may interfere with the study results or whose BMI is     < 25, will be excluded. The investigators will also exclude those who cannot converse     competently in English as special arrangements would need to be made for such people     attending the programme and this would be impractical in a group setting.      Those willing to participate will be invited for an individual appointment with the     dietitian, during which the study structure, aims and procedures will be explained and     consent to participate in the study will be obtained. For the first session of the programme,     participants will be asked to attend following an overnight fast. Blood samples will be taken     for basal measurement of glucose, HbA1c, lipids, insulin, glucagon, GLP-1, leptin, ghrelin     and adiponectin. They will then be given a standard 75 g glucose load and sampling repeated     at 30 mins (for peak GLP-1 levels). Baseline measurements of weight, height, percent body     fat, waistline circumference and blood pressure will also be taken during this session.     Following the assessment, patients will participate in the first session of the education     programme. The full assessment will be repeated at 4 and 8 months intervals.      The weight management programme will be run by the Specialist Dietitian. It will consist of 2     phases: an initial 4 month intensive weight loss phase, followed by a 4 month weight loss /     maintenance phase. The initial four month programme will consist of 8 group education     sessions and at least 3 phone calls. The following 4 month programme will consist of 5 group     sessions, at least 3 phone calls and 1 individual appointment. Each education session will     last 60min. Before the 1st session and, at 4 month and 8 month sessions, bloods will be     taken, as above. Before the rest of the sessions, there will be 15 minutes devoted to weight     assessment. The programme will be based on portion control and healthy eating and will be     supported by behavioural and cognitive change interventions. Such interventions will include     self monitoring, stimulus control, goal setting, problem solving and relapse prevention. The     specialists from Bournemouth HealthLink (a partnership backed by the local NHS, Council and     University) will take part in helping participants to increase their activity levels.      The aim is to achieve weight loss of 5% over the first 4 months with, as a minimum, weight     maintenance or possible further reduction over the subsequent four months.   "
218536|NCT00713544|"     This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid     Arthritis (RA) and if so how it compares to placebo (a substance which does not have any     action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when     added to treatment with methotrexate. The purpose of this study is also to find out which     dose of AZD5672 is the most effective at treating RA and to find out how well the body     tolerates AZD5672 when taken for up to 12 weeks.   "
218537|NCT00713557|"     SRACE is an multicenter observational database of outcomes for patients who are hospitalized     with an acute coronary events. SRACE includes over 20 hospitals in Shanghai China that have     enrolled a total of more than 3,000 patients since 2005, with an annual enrollment of 500     patients. The major purpose of the SRACE program is to evaluate the prognosis of patients     admitted to the hospital due to acute coronary events, comparing different therapeutic     strategies, in-hospital transferring system, and so on. All participating physicians receive     confidential quarterly reports showing ther outcomes side-by-side with the aggregate outcomes     of all participating hospitals.   "
218538|NCT00713570|"     Genetic research has provided the most exciting breakthroughs in neuroscience and cognitive     science. Partially genetically determined cognitive impairments have been described in people     with COMT, 5HT6, BDNF (Swillen et al., 2000; Moss et al., 1999, Henry et al., 2002, Bilder et     al., 2002)and biological systemic pathway candidate genes.      Selective inhibitors of COMT proved to improve cognitive function in animals and in patients     with Parkinson's disease (Carlsson, et al, 2000). Recent studies suggested that variation in     COMT activity might have neurobiological effects specific to the prefrontal cortex; the COMT     (Val) allele with high activity impairs tasks of prefrontal cognition in people with     schizophrenia (Egan et al., 2001) and higher loading of the COMT (Met) allele is associated     with better cognitive performance on attention and processing speed in people with chronic     schizophrenia (Bilder et al., 2002). Moreover, prefrontal dopamine levels are increased in     COMT knockout mouse model (Gogos et al., 1998). This suggests that in people who have     heterozygosis on COMT, dopamine levels could be abnormal. Thus, variation in COMT expression     could also affect performance on prefrontal cognitive tasks. In the previous study, we found     the neuropsychological profile in students with COMT (Met) allele is better in object     perception, problem solving and planning, and abstract and social thinking (Henry et al.,     2002).      5-HT6 inhibitor has been reported to raise extracellular acetylcholine levels in the cortex     and hippocampus (Dawson et al., 2001 and Riemer et al., 2003). Acetylcholine release in     hippocampal and cortical regions is known to be important for memory acquisition and     retention, and several groups have demonstrated that 5-HT6 blockade overcomes     scopolamine-induced amnesia. We hypothesize that variations in COMT and 5-HT6 are associated     with genotype that will cause a poor/better performance in cognitive tasks.      With the aim to establish the possible correlation between candidate genes (COMT, 5HT6,BDNF     and biological systemic pathway candidate genes. etc) and cognitive ability, which will     provide us an understanding on factors and its extent that affect students' thinking, and     then develop appropriate teaching models or strategies for assisting students in learning. It     seems timely, therefore, to consider how we might implement our increased understanding of     brain development and brain function to explore educational questions.   "
218539|NCT00713583|"     Cocaine dependence is a major public health problem and the development of a treatment for     this disorder is a priority. To date, treatment interventions based on positive incentive     principles have shown the strongest effects for improving substance use outcomes. One such     example is contingency management (CM) interventions in which nondrug rewards are used to     compete with cocaine. Recent evidence suggests that certain medications improve response to     CM interventions, particularly agents that target dopamine reward systems in the brain. A     promising dopamine-enhancing medication is levodopa. We have observed the strongest effects     of levodopa when the medication is administered in the context of CM therapy, perhaps through     mechanisms that enhance reward saliency. The proposed study is designed to further evaluate     this promising treatment approach. Cocaine dependent outpatients will participate in a     randomized, 2-group (levodopa vs. placebo), double-blind clinical trial. CM will be     behavioral therapy platform for both treatment groups. Potential treatment predictors related     to reward saliency and motivation will be assessed before and during treatment. We will test     the primary hypothesis that CM+levodopa will be more effective than CM+placebo in reducing     cocaine use. This study is expected to validate the usefulness of a new     behavioral-pharmacological treatment approach for cocaine dependence.   "
218540|NCT00713596|"     The purpose of this study is to determine whether the use of fibrin glue during nasal surgery     leads to a shorter recovery period with less bruising and/or swelling.   "
218541|NCT00713609|"     Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative     for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a     combination product including these actives for the treatment of acne vulgaris.      You may be suitable to take part in this study because you have acne vulgaris on your face.     Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms,     legs, and back.   "
218542|NCT00713622|"     Zonisamide (Zonegran) and sodium valproate (Epilim) are both medicines approved to treat     epilepsy. The purpose of this study is to find out the extent to which zonisamide may affect     memory and concentration, compared to sodium valproate.   "
218543|NCT00713635|"     The purpose of this study is to investigate the prenatal impact of abnormal cardiac structure     on neurodevelopmental outcomes in children with congenital heart disease.   "
218544|NCT00713648|"     The trial is conducted in Europe, North America and Asia. The aim of this trial is to     evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited     FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of     bleeding episodes.   "
218545|NCT00713661|"     The primary objective is to evaluate if the application of TachoSil® on a colorectal     anastomosis is feasible and safe.      The secondary objective is to establish and describe optimal application methods to be used     for educational purposes in future trials.   "
218546|NCT00713674|"     The purpose of this study is to examine treatment method of Methicillin-resistant     Staphylococcus aureus (MRSA) decolonization in patients.   "
218547|NCT00713687|"     In patients with cholangiocarcinoma therapeutic effects have been reported for     Gemcitabine/Oxaliplatin. Furthermore, photodynamic therapy (PDT) has significantly improved     patients survival in two randomised trials. PDT induces tumor necrosis only in an area of few     millimetres, while tumor parts which are located beyond this area remain untreated. An     additive effect could result from PDT as a local therapy in combination with systemic     chemotherapy.   "
218548|NCT00713700|"     The objective of this study is to investigate the safety and effectiveness of the ADO II in     patients with a PDA.   "
218648|NCT00706277|"     The aim of the study is to investigate the effects of total intravenous anesthesia (TIVA;     propofol, remifentanil) and balanced anesthesia (BAL; induction with propofol and fentanyl;     maintenance of anesthesia with sevoflurane and nitrous oxide) on pulmonary function 30     minutes after emergence from the general anesthesia.   "
218549|NCT00713713|"     Mechanical ventilation with low tidal volume (about 6 ml.kg-1) reduces mortality in ALI/ARDS     patients respect to high tidal volume ventilation (about 12 ml.kg-1).      This finding is usually explained by alveolar tidal overdistension associated to high tidal     volume. Stretch-induced lung injury may trigger a cytokine-mediated inflammatory response.     This may contribute to the development of systemic inflammatory response and multiple system     organ failure and death.      High tidal volume strategies might affect organ function by pathways not mediated by     inflammatory response.      It is well recognized the inverse relationship between tidal volume and cardiac output during     mechanical ventilation. Nevertheless there are no clinical studies about cardiac output     changes induced by low (6 ml.kg-1) and high tidal volume (12 ml.kg-1) in ALI/ARDS patients.      The study hypothesis is that high tidal volume ventilation reduces cardiac output in ALI/ARDS     patients respect to low tidal volume strategy. Thereafter reduced hemodynamic impact could     explain beneficial effect of low respect to high tidal volume ventilation.      If study hypothesis is confirmed, other studies should define the main cause of mortality     reduction related to low tidal volume strategies and if appropriate hemodynamic monitoring     and support should be required when low tidal volume strategies are harmful (i.e. traumatic     brain injury).   "
218550|NCT00713726|"     In newborn infants submitted to surgical procedures, tramadol may provide an effective     analgesia and decrease the time on mechanical ventilation support and the time to achieve     full enteral feeding.   "
218551|NCT00713739|"     The goal of this study is to conduct a prospective controlled trail of four currently     approved Department of Defense (DOD) - formulary medications for use as medical expulsion     therapy (MET) for kidney stones. Between 8% and 15% of Americans will develop symptomatic     urolithiasis in there life. Several medications, including steroids, calcium channel     blockers, alpha-adrenergic antagonists and non-steroidal anti-inflammatory drugs, have been     utilized to aid in the spontaneous passage of distal ureteral calculi. Recently, use of     selective alpha-blockers has shown promise for medical expulsion therapy (MET) of distal     ureteral calculi. None of these studies have been widely publicized outside the specialty of     urology. Recent studies have shown a success rate of nearly 90% when the selective     alpha-blocker tamsulosin (Flomax) was used for MET. MET has also been shown to result in a     decreased narcotic requirement, shorter time to stone passage, and reduced requirement for     further interventions. The investigators will evaluate the effectiveness of MET as initial     management for kidney stones using DOD-approved formulary medications.   "
218552|NCT00713752|"     The purpose of this study is to establish normal values for neuropsychological testing in HIV     negative Thais stratified by age (1 decade) and education (no certificate or primary school     certificate, less than high school certificate or vocational certificate, high school     certificate or higher vocational certificate or diploma, Bachelor degree or higher.   "
218553|NCT00713765|"     The aims of this study are to 1) examine the effects of AZD3480 and donepezil on the blood     concentrations of each other and 2) assess the safety and tolerability of the combined     administration of AZD3480 with donepezil.   "
218554|NCT00713778|"     The purpose of this study is to investigate the impact of electrocoagulation on ovarian     reserve after laparoscopic excision of ovarian cyst and the possible mechanisms.   "
218555|NCT00713791|"     This study is designed to see how different formulations of ZD4054 (Zibotentan) are absorbed     by the body. As for all clinical trials, safety and tolerability of the drug will be     evaluated.   "
218556|NCT00713804|"     People who have experienced mental illnesses like schizophrenia, bipolar disorder or     schizoaffective disorder often have a poor understanding of the causes of their illness, and     that they are often very worried about how the illness affects their families. In particular,     affected individuals worry that there is a high chance that any children that they have will     become affected with the same illness. Often, because of this fear, affected individuals     choose not to have children.      Genetic counseling is a process where information about the causes of illnesses, and about     chances for family members of individuals with these illnesses to become similarly affected     is provided in a supportive environment by a specially trained healthcare professional. This     study will investigate whether genetic counseling can reduce perceptions of risk and stigma,     and increase perceived control and knowledge about the causes of the illness, amongst     individuals who have a major mental illness.   "
218557|NCT00713817|"     The purpose of this study is to assess the maintenance of effect after long-term treatment of     Sativex® in subjects with neuropathic pain.   "
218602|NCT00705679|"     A new approach to HIV prevention currently being studied includes the use of microbicides,     substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and     emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral, FDA-approved, anti-HIV drugs,     and tenofovir gel is an experimental microbicide. The purpose of this study is to determine     the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal placebo gel, and     the safety and effectiveness of oral TDF and oral FTC/TDF compared to an oral placebo in     preventing HIV infection among women at risk for sexually transmitted infections.   "
218558|NCT00713830|"     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in     comparison to placebo, as an add-on treatment to sulfonylurea without or with metformin, over     a period of 24 weeks of treatment, followed by an extension.      The primary objective is to assess the effects of lixisenatide when added to sulfonylurea     with or without metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c)     reduction (absolute change) at Week 24.      The secondary objectives are to assess the effects of lixisenatide on percentage of patients     reaching HbA1c less than (<) 7 percent (%); percentage of patients reaching HbA1c less than     or equal to (<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed     by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG),     glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a     sub-study in all patients in selected centers; to evaluate safety, tolerability,     pharmacokinetics (PK) and anti-lixisenatide antibody development.   "
218588|NCT00714220|"     The work of Nau et. al (Nau KL, Bromberg MB, Forshew DA, Katcha Vl. Individuals with     amyotrophic lateral sclerosis are in caloric balance despite losses in mass. J Neurol Sci     1995;129 :47-49) showed that patients in the early stages of ALS initially increase their     body fat. Another study showed that advanced ALS patients on mechanical ventilation were     actually hypometabolic, supporting a hypothesis that ALS patients' daily oral intakes of     calories fail to match their energy requirements, thus exacerbating their condition. This     current study investigates and compares substrate utilization using a metabolic cart in     controls and in ALS patients who are on and off ventilatory support to examine differences in     substrate utilization between the two groups of ALS patients and the controls. (Substrate     utilization is essentially the percentage of fats, carbohydrates, and protein utilized by the     body.) The study will increase our understanding of the nutritional needs of ALS patients and     improve our ability to provide the best possible nutrition in progressive illness.   "
218559|NCT00713843|"     Background of the study: Manual Therapy applied to patients with non-specific neck pain has     been investigated several times, both internationally and nationally. In the Netherlands     different types of manual therapy treatment exist. Manual Therapy, as practiced under the     Utrecht School, has not been subject of a randomized controlled trial. There is a need to     evaluate the effectiveness of this type of manual therapy.      Objective of the study: This trial will investigate the effectiveness of Manual Therapy in     the short and long-term up to 52 weeks in patient with (sub) acute (minimal two weeks) and     chronic (maximum 52 weeks) since last episode of neck pain. Functional state, pain and global     perceived effect are the outcome variables.      Study design: The study is a single blind randomized controlled trial.      Study population: Men and women aged 18 to 70 years old with neck pain for at least two     weeks.      Intervention: The experimental group will be treated with manual therapy for a period of six     weeks. The control group will be treated with physical therapy (usual care) also for a period     of six weeks.      Primary study parameters / outcome of the study: Global Perceived Effect (GPE) and the Neck     disability index (NDI-DV ) will be applied.      Secondary study parameters / outcome of the study: Visual Analogue Scale (VAS) for pain and     SF36 (Quality of life). The Multidimensional Health Locus of Control(MHLC ),     Credibility/Expectancy Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ-DLV) will     also be measured.   "
218560|NCT00713856|"     The study objective is to compare the clinical outcomes using wavefront guided PRK with iris     registration and conventional laser PRK using FDA-approved laser technology on the same     patient.   "
218561|NCT00713869|"     Over the past several decades, considerable effort has been expended toward the successful     cryopreservation of various human cells. While attempts at cryopreservation have been     directed at different tissue types, one of the most vigorously pursued targets has been     reproductive tissue. Historically, cryopreservation of human sperm has existed for several     decades. The earliest reports of pregnancies (Trounson et al., 1983) and births (Zeilmaker et     al., 1984) from the cryopreservation of human embryos occurred in the early 1980s. Presently,     the freezing and storage of human embryos following in vitro fertilization (IVF) is standard     practice at most fertility clinics. In 2003, the CDC Assisted Reproductive Technology success     rates report stated that 4,246 live births occurred out of 17,517 non-donor frozen embryo     cycles. . Because the human egg is a relatively voluminous cell with abundant cytoplasm,     crystallization at the time of freezing may result in damage to the organelles. Secondly, a     mature metaphase II oocyte contains a fragile spindle apparatus involved in cleavage.      The purpose of this research study is to evaluate a method of freezing and thawing oocytes.     This evaluation will be made by comparing the survival rates and rates of fertilization,     cleavage and embryo quality of fresh oocytes and frozen-thawed oocytes which will be     inseminated during the IVF (in vitro fertilization) treatment cycle. In addition, the same     comparisons will be made between frozen oocytes from infertile women and those of egg donors.     You are being asked to be in this study because you are currently undergoing in vitro     fertilization.   "
218562|NCT00713882|"     The aims and objectives of this research are to identify chronic health conditions,     psychological disease, quality of life issues, and patient preferences for survivorship care     in patients who have survived aggressive lymphoma.      Subjects will be asked to participate in an oral interview with the primary investigator,     either in-person or over the telephone. It is estimated that the survey will take about an     hour.   "
218563|NCT00713895|"     The research study examined the feasibility, implementation, and efficacy of the interactive     expert system intervention for smoking cessation in the Chinese American population.   "
218564|NCT00713908|"     The purpose of this study is to evaluate how often women have problems passing their urine     (voiding) after TVT (Tension Free Vaginal Tape) surgery. This will help us to better     understand normal voiding function after surgery as well as to find factors that may help us     predict who will have problems after surgery.   "
218565|NCT00713921|"     Develop and quantify methods for evaluating bladder dysfunction in diabetes and stroke   "
218603|NCT00705692|"     Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to     Hepatitis B virus (HBV) vaccination in hemodialysis patients. The aim of this study was to     evaluate the effect of levamisole supplementation on tetanus-diphtheria (Td) vaccine response     rate in hemodialysis patients.   "
221900|NCT00757627|"     The purpose of this study is to collect disease burden of OA and the effectiveness and     patient satisfaction of treatment by Etoricoxib in the normal practice setting.   "
218566|NCT00713934|"     Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is     one of the only effective therapies available to such patients. However, lack of donors,     surgical complications, rejection, and high cost are it`s serious problems. The potential for     stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently     confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases,     and several clinical studies have applied BMC injection to induce regeneration of myocardium     and blood vessels. In this study we will evaluate safety and feasibility of autologous bone     marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation     through the portal vein in patients with decompensate cirrhosis.   "
218567|NCT00713947|"     Low dose of aspirin is the main cause of gastro-duodenal ulcer. The best prevention is not     definite particularly in patients without history of ulcer and infected by H. pylori.The aim     of the study is to evaluate the gastric damage induced by aspirin in patients with H. pylori     infection but who have any history of ulcer.   "
218568|NCT00713960|"     Quality Improvement in Primary Care: delegation of check-ups to nurses in general practice   "
218569|NCT00713973|"     Background: Compare the American and Brazilian protocols for prophylaxis of deep vein     thrombosis (DVT), seeking to draft a new protocol, more comprehensive and applicable.     Methods: A prospective study was conducted over a year, covering 212 patients, comparing the     protocols on the stratification of risk of DVT, and the type of prophylaxis indicated. A new     protocol was proposed, applied and compared to previous.   "
218570|NCT00713986|"     Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This     study objective is to test the efficacy regarding pain attenuation of 3 interventions     (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus     control in healthy newborn infants submitted to intra-muscular vaccination for Hepatitis B at     48-72 hours of life.   "
218571|NCT00713999|"     A cross-sectional study of urogenital schistosomiasis and sexually transmitted infections     (STI) prevalence and associated morbidity in a rural community in Madagascar. Clearance of     infections and resolution of morbidity were subsequently studied in two phases following     systematic anti-STI and anti-schistosoma treatment, respectively.   "
218572|NCT00714012|"     Our objective is to develop intuitive, meaningful and ergonomically efficient informative     displays specific to the user's domain.   "
218576|NCT00714064|"     PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination     for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can     prevent ear disease in infants. Mothers will receive the 23 valent pneumococcal     polysaccharide vaccine (23vPPV) either: a) during the third trimester of pregnancy; b) soon     after child birth; or c) seven months after child birth (control group). The adult     diphtheria, tetanus and acellular pertussis vaccine (dTpa) will be used as the control     vaccine for the birth dose.      The study aims to recruit 210 Indigenous women aged 17-39 years who have an uncomplicated     pregnancy. Following recruitment, subjects will be randomly assigned to one of the three     groups.      Each mother and infant will be followed from pregnancy until the baby is seven months of age.     All routinely recommended vaccinations on the standard vaccination schedule will continue to     be offered by the subject's vaccine provider in accordance with current clinical practice.      The primary outcome will be prevalence of middle ear disease at seven months of age, defined     as middle ear effusion or tympanic membrane perforation or acute otitis media. Pneumatic     otoscopy, video-otoscopy and tympanometry will be used in the ear examinations. The primary     analyses will be a direct comparison of the proportion of infants in the control group who     have nasopharyngeal carriage of one or more vaccine type pneumococci at seven months of age     compared to infants in each of the other two groups. A similar comparison of the proportion     with middle ear disease will be undertaken between the control group and the respective     intervention group.   "
218577|NCT00714077|"     The purpose of this study is:        -  To compare the long-term of survival and local/regional control between the two          postoperative concurrent chemoradiotherapy regimens: capecitabine vs. oxaliplatin and          capecitabine,for stage II and III rectal cancer        -  To compare the toxicity profile between the two different concurrent chemoradiotherapy          regimens.   "
218578|NCT00714090|"     The purpose of this study is to assess the efficacy of add-on therapy with repetitive     Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive     disorders compared to venlafaxine only (the optimal medication) and to rTMS only.   "
218579|NCT00714103|"     The goal of this clinical research study is to find the highest safe dose of the drug     8-chloro-adenosine that can be given in the treatment of chronic lymphocytic leukemia (CLL).     Another goal is to learn how effective the drug is at treating leukemia.   "
218580|NCT00714116|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK),     and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).   "
218581|NCT00714129|"     The worldwide epidemic of obesity is paralleled with increased cases of non-alcoholic liver     disease (liver fat accumulation) and diabetes. Fat belongs in the adipose tissue, and if     excess fat accumulates in the liver or muscle, these tissues cannot use sugar efficiently. It     has been discovered that when large quantities of fructose (a sugar present in soft drinks)     are consumed, the conversion of carbohydrate (CHO) to fat in the liver increases.      We hypothesize that: 1) subjects with fatty liver have a higher CHO uptake and conversion to     fat in their liver when compared to matched control subjects with normal liver fat content;     and that: 2) when subjects with fatty liver are fed a diet limiting fructose and simple     sugars will decrease their liver CHO fat content. This reduction in liver fat will normalize     the way the liver responds to sugar and insulin, reversing the pre-diabetic state.      The measurement of these parameters will be done using state-of-the-art techniques such as     safe non-radioactive isotope tracers and non-invasive magnetic resonance spectroscopy.      For more information, please call 415-206-5532 for a phone screening   "
218604|NCT00705705|"     This study will determine whether an HIV prevention program that targets the inner workings     of social networks at high risk for HIV and other sexually transmitted diseases is effective     in reducing frequency of high-risk sexual behaviors among network members.   "
218605|NCT00705718|"     To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of     Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.   "
218582|NCT00714142|"     Two investigational chemical tracers, 62Cu-ethylglyoxal bis(thiosemicarbazone) (62Cu-ETS) and     15O-water, will be used in this study to look at how blood moves through the kidneys. The     purpose of the study is to see if 62Cu-ETS is effective in showing the blood supply to the     kidneys compared to 15O-water. The tracer mixes with the blood and moves through the body.     Using positron emission tomography (PET scan) the researchers can see the tracer and can     learn more about how the blood moves through the kidneys. The study invites participants who     are healthy, without any heart or kidney disease, patients who have kidney disease that     require dialysis, and patients who may have a blockage in one of the arteries supplying blood     to the kidneys.   "
218583|NCT00714155|"     The purpose of this study is to evaluate the long-term success rate of the colpocleisis     procedure and its effect on quality of life in women who have this surgery. We want to see if     women who have this surgery have problems with recurrent pelvic organ prolapse, urinary     incontinence, or bowel problems after the surgery. We also want to see how the surgery     affects women's sexuality.   "
218584|NCT00714168|"     The number of overweight and obese adults in the United States is increasing at a rapid rate.     A stepped-care weight loss program, which at key times increases the frequency of contact     between an individual trying to lose weight and the program staff, may be beneficial for     achieving long-term weight loss. This study will compare a standard behavioral weight loss     program with a stepped-care weight loss program in their abilities to help people who are     overweight or obese to lose weight.   "
218585|NCT00714181|"     RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine and temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of hydroxychloroquine     when given together with temozolomide in treating patients with metastatic or unresectable     solid tumors.   "
218586|NCT00714194|"     This is an intervention study whose purpose is to determine whether daily interruption of     sedative infusion contributes to the reduction of the occurrence of delirium and improves     sleep perception in critically ill patients. Patients in a trauma intensive care unit (TICU)     receiving mechanical ventilation and continuous infusion of sedatives will be enrolled in the     study. A patient will be entered into the study after the family member has consented to have     the patient participate.   "
218587|NCT00714207|"     The purpose of this study was to determine if a school-based multi-session group smoking     cessation program is more effective than a single session group program.   "
218660|NCT00706433|"     The purpose of this study is to determine and compare the safety and efficacy of multiple     broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle     (VEH-PDT) in subjects with moderate to severe facial acne vulgaris.   "
218589|NCT00714233|"     A 24 week study to compare the use of Metformin, birth control pills and a carefully planned     intensive lifestyle program that includes weight loss and exercise. These approaches will be     compared to placebo (a pill that contains no active substances. Metformin, birth control     pills and the lifestyle management program will be used on this research study to compare     their ability to:        1. reduce fasting glucose levels        2. reduce androgen hormone levels        3. improve sex steroid binding, and        4. improve lipids (fatty substances in the blood)   "
218590|NCT00714246|"     This is a phase I/II study. The phase I portion of the study will determine the maximum     tolerated dose of bortezomib when administered in combination with carboplatin & docetaxel     and to determine the efficacy of the combination for patients with advanced NSCLC. Phase II     will determine time to progression and overall survival and determine changes in serum     proteomics patterns before & after combination therapy.   "
218591|NCT00714259|"     A non-myeloablative treatment strategy and uniform selection criteria will enable patients     with a variety of low grade B-Cell malignancies to attain long term disease control without     unacceptably high treatment related mortality.   "
218592|NCT00714285|"     The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza     vaccine candidate compared to a licensed trivalent influenza vaccine in adults.   "
218593|NCT00714298|"     Early diagnostic of non ST elevation coronary syndrome in patients admitted to the emergency     room is difficult. Two news biochemical markers have been assessed and studies have suggested     that heart fatty binding protein and ischemia modified albumin are early markers of     myocardial necrosis and myocardial ischemia. The aim of the study is to analyse the     predictive value of association of heart fatty binding protein and ischemia modified albumin     for non ST segment elevation acute coronary syndrome diagnosis in the first hour of     management in the emergency room.   "
218594|NCT00714311|"     The purpose of this study is to find out whether Transference-Focused Psychotherapy (TFP) is     effective in the treatment of Borderline Personality Disorder.   "
218595|NCT00714324|"     The purpose of this study is to determine if patients are able to reliably screen themselves     for nutrition risk.   "
218596|NCT00714337|"     To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to     the AZD1386 oral solution.   "
218597|NCT00714350|"     Our objective is to develop intuitive, meaningful and ergonomically efficient informative     displays specific to the user's domain. Specifically we aim to enhance and refine the display     prototype of ABG information to include gas-exchange, acid-base balance, lung mechanics,     ventilation, oxygenation, and metabolism information.   "
218598|NCT00714363|"     The objective of the study is to compare clinical outcomes from LASIK and SBK using     FDA-approved laser technology on the same patient   "
218599|NCT00714376|"     The purpose of this study is to assess the response to Taxotere (docetaxel) chemotherapy     given as a primary treatment to patients with early and rapid PSA rising after prostatectomy     for high risk disease.   "
218600|NCT00714389|"     The goal of this study to determine normal values for certain urinary measurements in order     to better understand voiding dysfunction in women.   "
218601|NCT00714402|"     The purposes of this study are:        1. To determine whether procalcitonin level at admission of pediatric patients with          bacterial infections can be used as a marker for prediction of defervescence and          hospitalization length        2. To examine the kinetics of procalcitonin in pediatric patients with bacterial infections          and persistent fever   "
218606|NCT00705731|"     This study will compare patient adherence to different colorectal cancer (CRC) screening     tests to identify the most cost-effective strategy to decrease mortality from CRC. We     hypothesize that different types of tests will have different adherence rates, that these     rates will alter the cost-effectiveness analysis, and that we can identify patient variables     associated with non-adherence to specific CRC screening strategies.   "
218607|NCT00705744|"     To prove the absence of photo irritation and photo sensitivity potential of the product     Dermacyd Femina.   "
218608|NCT00705757|"     The purpose of this study is to study changes in skin color that may be caused by using one     of the three eye medicines: Xalatan, Travatan or Lumigan.   "
218609|NCT00705770|"     The purpose of this study is to determine whether Anecortave Acetate is effective for     lowering intraocular pressure caused by open-angle glaucoma.   "
218854|NCT00715767|"     This is a randomized, multi-center intervention trial comparing two educational programs on     healthcare provider performance in the Botswana national hospital system. This study     addresses the critical question of how to effectively and consistently measure and associate     CPR knowledge and psychomotor skills, enabling the optimization of the learners' environment.   "
218610|NCT00705783|"     The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an     intramuscular depot formulation of aripiprazole as maintenance treatment in patients with     schizophrenia.      The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient     to be converted from their current antipsychotic treatment to oral non-generic aripiprazole     monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2, the patient was     stabilized on oral non-generic aripiprazole monotherapy (oral stabilization phase from a     minimum of 4 weeks to a maximum of 12 weeks). Once the patient was stabilized in Phase 2,     they entered Phase 3, the single-blind intramuscular (IM) depot aripiprazole stabilization     phase. The goal of the phase was to stabilize the patient on the IM depot aripiprazole     formulation for a minimum of 12 weeks to a maximum of 36 weeks. When the patient was     stabilized, they were eligible to be randomized into the double-blind IM depot maintenance     phase (Phase 4). During Phase 4, the patient was assessed for exacerbation of psychotic     symptoms and/or impending relapse for up to 52 weeks.   "
218611|NCT00705796|"     Exogenously administered testosterone will override the normal negative feedback of     endogenous testosterone on the hypothalamus and pituitary. Constantly, relatively high and     constant testosterone levels will cause a drop in FSH and LH production by the pituitary.     Since FSH and LH are signalling hormones to the testes, endogenous testosterone production     and spermatogenesis will be down-regulated. It is expected that intranasal dosing in the     morning will mimic the normal physiological pattern of testosterone production thereby     avoiding negative side-effects on spermatogenesis. Trans-dermal gels give testosterone levels     more or less constant over the day and will very likely have inhibitory effects on     spermatogenesis.      The main objective of this study is to show that twice daily intranasal dosing does not have,     or has a smaller inhibitory effect on spermatogenesis in comparison to transdermal     testosterone gels.   "
218612|NCT00705809|"     Background:        -  The T-Cell Project, sponsored by the International T-cell non-Hodgkin Lymphoma Study          Group, is a consortium of institutions interested in achieving more detailed information          on clinical and biological characteristics of T-cell lymphomas.        -  The T-Cell Project serves as a repository for data on patients with peripheral T-cell          lymphoma (PTCL) worldwide. Its overall goal is to improve T-cell subtype classifications          and evaluate treatment strategies for each subtype.      Objectives:      -To implement a standardized epidemiologic questionnaire into the ongoing T-Cell Project to     allow evaluation of various potential risk factors for PTLCs.      Eligibility:      -Untreated patients 18 years of age and older who were diagnosed with PTLC September 1, 2006,     or later.      Design:      -Patients complete a questionnaire containing the following information:      Demographic information      Smoking history and alcohol use      Personal history or cancer      History of cancer among first-degree relatives      Medical history      History of transplants      History of blood transfusions      Medication use      Occupational and residential history      Pesticide treatment      -The information collected is linked to clinical and pathologic information in the T-Cell     Project database.   "
218613|NCT00705822|"     To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and     experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values.      To determine the time to treatment failure in both strategies To determine the overall and     specific cause survival To evaluate the safety profile To analyze the Quality of Life   "
218614|NCT00705835|"     The purpose of this research is to help us study a vaccine treatment for patients with     prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections     and other diseases, such as cancer. Your immune system is made up of many different types of     cells which fight infection and disease in your body. A vaccine may stimulate the immune     system to destroy the cancer cells. It may also help to slow the growth of the cancer. The     vaccine is a solution given as an injection into or under the skin. It is made up of several     parts. The first part is PSMA, a protein present in many cancers, especially prostate cancer.     It is referred to as rsPSMA when made in a laboratory for this study and is mixed with a     material called Alhydrogel® (aluminum hydroxide suspension) which helps the immune system to     make more cancer-fighting cells.   "
218615|NCT00705848|"     It is not clearly understood what causes tracheobronchomalacia (weakening of the windpipe and     airways) or tracheal stenosis (narrowing of the windpipe). We plan to take biopsies (small     pieces of tissue) and brushings (to collect the cells that form the lining of the airway)     from the airways of patients with these diseases and analyze these samples in a laboratory to     try and determine the mechanism of disease. We will compare the results with that of patients     with normal airways.   "
218616|NCT00705861|"     The purpose of this study is to evaluate the efficacy and safety of SK3530 on erectile     dysfunction in Patients with Diabetes Mellitus.   "
218617|NCT00705874|"     This study will aims to determine the maximum tolerated dose of CGC-11047 when used in     individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or     cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047     will be escalated until the maximum tolerated dose is established.   "
218618|NCT00705887|"     The specific aims of this research are:      Aim 1 - To describe the UV protection behaviors and beliefs of young adult patients in a     dermatology clinic.      Aim 2 - To examine whether or not the UV protection behaviors and beliefs of young adult     dermatology patients are associated with age, gender, level of education, marital status,     contact with skin cancer, time outdoors, skin type, the reason for their visit, and the date     of data collection.      Aim 3 - To test the efficacy of a motivational enhancement approach to UV protection     counseling for young adult dermatology patients, as manifested by favorable changes in UV     protection stages of change, UV protection self-efficacy, and UV protection attitudes.   "
218619|NCT00705900|"     The purpose of this study is to compare the safety and effectiveness of a new topical LCD     solution and a commercially available calcipotriol (Vitamin D) cream in reducing the symptoms     of plaque psoriasis and improving the quality of life in adults.   "
218620|NCT00705913|"     The purpose of this study is to compare sizing,implant techniques, and hemodynamics between     the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.   "
219379|NCT00722813|"     This is a research study to determine patient preferences between two different diagnostic     tests; a CT angiogram (CTA) and a catheter angiogram, both of which are used at the     University to screen for and detect heart disease.   "
218624|NCT00705965|"     In patients with coronary artery disease (CAD), depressive symptoms are frequent and highly     relevant for quality of life, health behaviour, health care costs, and prognosis. The aim of     the current study is to evaluate the effects of a psychotherapy intervention on symptoms of     depression in patients with CAD. Therefore, depressed patients diagnosed with CAD will be     randomised into a controlled intervention trial, comparing a stepwise psychotherapy     intervention with usual cardiological care. The manualized psychotherapy intervention starts     with three individual sessions offered on a weekly basis. Afterwards, symptoms of depression     will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25     sessions of psychodynamic group psychotherapy over a total period of one year. The     psychodynamic approach was chosen in order to specifically take into account personality     traits such as negative affectivity and social inhibition, the components of the Type D     personality, which may explain why recent cognitive behavioural psychotherapy (CBT) trials     produced only small effects in depressed CAD patients. The investigators expect that the     intervention will reduce depressive symptoms as well as the prevalence of depressive     disorders. It will also improve both behaviourally and physiologically mediated     cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs.     Subgroup analyses will be performed in order to identify gender-specific treatment effects,     effects on immunological stress reactivity, and genetic predictors of treatment success.   "
218625|NCT00705978|"     This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term     safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be     assessed and correlated with CFA.   "
218626|NCT00705991|"     Das Hauptziele der Studie ist das ROTEM® zu validieren durch die Untersuchung von:      i) Reproduzierbarkeit von ROTEM® ii) Präzision der ROTEM®-Tests, sowie iii) der Zeitspanne,     während derer die Ergebnisse in Zitrat-Blut reproduzierbar sind      Die durchzuführenden Tests sind FIBTEM, EXTEM, INTEM in ROTEM® um die Funktion der     Thrombozyten während der Lagerungszeit zu untersuchen.      Nur Zitrat-Blut wird den Patienten abgenommen, die Reklazifikation findet kurz vor der     Durchführen der Tests stattfinden, um so nahe wie möglich an der klinischen Praxis zu sein.   "
218627|NCT00706004|"     The purpose of this study is to determine the short term safety and effectiveness of     lubiprostone when used for constipation in adults with cystic fibrosis.   "
218628|NCT00706017|"     This observational study is conducted in North America. The aim of this observational study     is to evaluate the incidence of adverse events while using Levemir® under normal clinical     practice conditions.   "
218629|NCT00706030|"     The purposes of this study are to identify the highest tolerable dose of neratinib (HKI-272)     in combination with vinorelbine and to assess the safety of the combination of the two drugs     as well as to obtain preliminary information on whether the combination of the two drugs has     any effect on solid tumors.      The study will be conducted in two parts. In the first part, testing will be done on up to 12     subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with     advanced solid tumors. In the second part of the study, approximately 60 additional subjects     with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib (Tykerb®),     are planned to be added to better define the tolerability and preliminary activity of HKI-272     in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast     cancer with prior lapatinib (Tykerb®) exposure are also planned to be enrolled in part 2 for     exploratory analyses.   "
218630|NCT00706043|"     Low back pain is a very common disease. Among the persons suffering of acute low back pain,     about 10% are at risk of developping chronic pain. A screening questionnaire assessing this     risk has been developed and validated in Swedish and English (Orebro Musculoskeletal Pain     Screening Questionnaire, Linton, 2003). The aim of our study is to validate a french     translation of this questionnaire. Patients suffering from acute low back pain will be asked     to fill in several questionnaires at day 0, and 6 and 12 month later.   "
218631|NCT00706056|"     The objective of this study is to determine whether systemic blood pressure in the body is     related to the development and progression of normal tension glaucoma in the eye. The study     aims to clarify whether subjects with episodes of hypotension (low blood pressure) at night     are at increased risk for sight loss and the development of normal tension glaucoma.   "
218632|NCT00706069|"     This study will evaluate the toxicity and secondary the efficacy of the combination     vinorelbine plus capecitabine in metastatic breast cancer patients   "
218633|NCT00706082|"     A two-stage prospective observational cohort study in scleroderma patients to evaluate     screening tests and the incidence of pulmonary arterial hypertension and pulmonary     hypertension   "
218634|NCT00706095|"     This is an open-label, three-parallel group pharmacokinetic study. Patients with advanced     solid tumors will be assigned to one of three groups to receive I.V. doses of eribulin     (E7389). The three groups are: normal hepatic function, mild hepatic impairment (Child-Pugh     A) and moderate hepatic impairment (Child-Pugh B) according to the Child-Pugh System for     classifying hepatic impairment.   "
218635|NCT00706108|"     The impact of different coordination patterns on team performance during anesthesia     inductions are analyzed using videotapes. These records are examined using various     categorization systems (ETHZ), focussing on changes of coordinative behaviour with shifting     situational requirements. A rating system comprising multiple categories is used to evaluate     team performance. An integrated simulator study facilitates validation of the rating system.   "
218636|NCT00706121|"     RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on     the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors     predict a participant's response to treatment and help plan the best treatment.      PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on     colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.   "
218637|NCT00706134|"     This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in     elderly patients with essential hypertension when given with a light meal.   "
218855|NCT00715780|"     This study is conducted in Asia. The aim of this observational study is to evaluate the     incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy     while using insulin under normal clinical practice conditions. The switch from OAD treatment     to insulin therapy will be determined by physician.   "
218638|NCT00706147|"     The purpose of this study will be to demonstrate the safety, tolerability, and efficacy of     arimoclomol in subjects with SOD1 positive familial Amyotrophic Lateral Sclerosis (ALS). This     type of ALS is HEREDITARY (runs in families), and at least one other person in the family     must have had ALS.      Study hypotheses: Arimoclomol, taken at a dose of 200 mg three times daily will improve     survival as defined by time to death, tracheostomy or permanent assisted ventilation. In     addition, it will be safe and well tolerated in subjects with SOD1 positive familial ALS.      Funding Source - FDA-OOPD   "
218639|NCT00706160|"     This study will examine how certain language skills, such as naming objects, understanding     spoken language and reading are organized in the brain and how they are affected by seizures.      People with epilepsy who are considering surgery and healthy volunteers who are right-handed     and between the ages of 7 and 55 may be eligible for this study. Participants undergo the     following procedures twice, and, in some cases, possibly three times, in two or three visits     of 2 to 4 hours each.      Neuropsychological tests: Testing includes questionnaires, pen-and-pencil or computerized     tests and motor tasks.      Structural MRI: This procedure uses a strong magnetic field and radio waves to obtain     pictures of brain structure. During the test, the subject lies in the scanner (a metal     cylinder surrounded by a magnetic field) for about 90 minutes, wearing earmuffs to muffle     knocking noises the machine makes. Subjects may be asked to lie still for up to 10 minutes at     a time.      Functional MRI: This procedure is similar to structural MRI, except a coil is placed over the     head and the subject performs simple tasks during the procedure. The pictures obtained show     what parts of the brain are being used to perform the task. The test lasts about 60 minutes,     with subjects asked to lie still for up to 10 minutes at a time.      Magnetoencephalography (MEG) and electroencephalography (EEG): For MEG, the subject sits in     an MEG recording room with a cone containing magnetic field detectors lowered onto his or her     head. Very small magnetic changes produced by the activity of the brain are recorded while     the subject sits quietly or performs a research task. An EEG recording of the electrical     activity of the brain is done at the same time as the MEG.   "
218640|NCT00706173|"     Developing novel and effective pharmacologic interventions for this post-traumatic stress     disorder is important. The investigators propose to replicate findings of an earlier     published pilot study using low dose hydrocortisone as a treatment for PTSD. In order to do     so in a more meaningful way, the investigators will conduct a larger but similar randomized     double-blind placebo-controlled, cross-over design treatment study examining the use of low     dose hydrocortisone (or placebo) for 4 weeks in combat veterans suffering from PTSD.      The investigators hypothesize that, as described by Aerni et al. (2004), administration of     daily hydrocortisone will lead to a reduction in PTSD symptom severity, but particularly for     re-experiencing types (e.g., flashbacks, nightmares)of symptoms. The investigators also hope     to examine potential predictors and moderators of treatment response based on subjects'     clinical characteristics, as well as serum cortisol and ACTH levels.   "
218641|NCT00706186|"     Eligible patients will undergo this open label initial safety and feasibility study     investigating the use of 6 g/day sodium oxybate in mild AD. A total of 5 visits are included     with this trial and total subject participation duration of 7-8 weeks. The screening phase     will include an initial screening visit and a screening PSG night. After successful     screening, subjects will complete a baseline PSG night and undergo a third PSG night to     monitor initial safety and compliance with study drug at a dosage of 4.5 g/day of sodium     oxybate. Thus the subject will undergo three consecutive nights of PSG in the sleep center.     The patient will maintain a dosage of 4.5 g/day for a duration of 7 days leading to Treatment     Visit 1. After successful assessment at Treatment Visit 1, the dosage will be increased to 6     g/day for the duration of the trial. At Treatment Visit 2 (day 21), the dosage will be     increased to a dosage of 9 g/day, if tolerated by the patient. The remaining visit will occur     at 6 weeks after baseline, with Treatment Visit 3 consisting of two consecutive nights of     PSG. Participation will be complete after this visit. Phone follow-up will be made at one     week post completion visits to assess any wash-out symptoms. Please refer to Figure for flow     of the study design.   "
218642|NCT00706199|"     Antigen expression levels in bone marrow from volunteering donors will be analyzed. The     results of this analysis will be used to establish a clinical test to identify cancer     patients who could qualify to receive an investigational treatment being developed by     GlaxoSmithKline.   "
218643|NCT00706212|"     PET CT is one of the imaging tools that are used for staging of urological malignancies.      C11 Choline is a novel isotope with the advantage of its minimal secretion in the urine. This     advantage makes it a potentially better metabolic marker then others such as FDG. Preliminary     studies showed ~95% sensitivity in the diagnosis of TCC. Our Goal is to continue the     evaluation of this method as a diagnostic and follow up tool in different urological     malignancies.   "
218680|NCT00706719|"     The study was designed to determine if Androxal® would affect sperm parameters (count,     concentration, volume) in men with secondary hypogonadism who have been previously treated     with topical testosterone.   "
218644|NCT00706225|"     Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which     is being studied for possible prevention and treatment of postmenopausal osteoporosis.      PREMARIN® (conjugated estrogens [CE]) is approved by FDA to treat moderate to severe symptoms     of menopause (i.e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of     postmenopausal osteoporosis.      The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution,     breakdown and elimination in the body) of a single dose of PREMARIN® when administered     together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women.      Information will also be obtained regarding the safety and tolerability of the study     medications when given together to healthy postmenopausal women.   "
218645|NCT00706238|"     This study is being done to evaluate the safety and the clinical activity of MAGE-A3     Antigen-Specific Cancer Immunotherapeutic in patients with unresectable and progressive     metastatic cutaneous melanoma.   "
218646|NCT00706251|"     For patients with chronic epiphora, Dacryocystorhinostomy is currently the gold standard     treatment, with a success rate of 80-90% according to literature. Another available     treatment, which is far less used, in nasolacrimal intubation, using a silicone tube.      In our study, we would like to find the efficacy of nasolacrimal duct intubation, which was     performed in our medical center on a few hundred patients with mild epiphora.      Study hypothesis: nasolacrimal intubation in adults, with a clinically mild epiphora, is     close in it's efficacy to the Dacryocystorhinostomy procedure.   "
218647|NCT00706264|"     Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in     pregnant women with short cervical length at 18-22 weeks scan.   "
218649|NCT00706290|"     RATIONALE: Providing cognitive-behavioral therapy (CBT) may reduce anxiety and improve     quality of life of patients with advanced cancer.      PURPOSE: To examine the development and pilot testing of a brief cognitive-behavioral therapy     intervention to treat anxiety and improve quality of life in patients with advanced cancer.      Hypothesis: Patients with anxiety associated with advanced cancer who receive CBT will report     significantly fewer anxiety symptoms compared to those in the comparison condition.   "
218650|NCT00706303|"     Training patients to alter their own therapy early in the course of a developing exacerbation     (self-management) has been shown to improve outcomes in asthma, but there is no good evidence     on this for patients with Chronic Obstructive Pulmonary Disease (COPD). Case management, with     patients having an identified contact who helps them access care when necessary, has been     shown to improve outcomes in recent studies. A combined approach, called supported     selfmanagement, may be particularly suitable for this socially and often educationally     disadvantaged group of patients.We propose to identify 500 patients at the time of an     exacerbation to test this combined strategy in a randomised manner. The primary outcome     measure will be readmission to hospital or death due to COPD, important in terms of patient     preferences, quality of life and health costs. This will provide important information about     intermediate care for COPD patients which should influence service provision within the NHS     in Scotland   "
218651|NCT00706316|"     Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant     spread, NPC is sensitive to radiotherapy and chemotherapy; however, if NPC relapses or     spreads to other organs, treatment options are limited. This grant proposes to evaluate the     safety and tolerability of a novel treatment for patients with NPC that has either relapsed     or spread to distant organs. Epstein-Barr Virus (EBV) is known to play a role in the     development of NPC, and studies have shown that NPC tumor cells express proteins that are     related to EBV. Some of these proteins can trigger a response from the immune system,     specifically the activation of cytotoxic T lymphocytes (CTLs), a type of immune cell that     might exert anti-tumor effects. In this project, we will take blood from NPC patients,     generate CTLs targeted against EBV, and re-infuse these back into patients in an attempt to     achieve anti-tumor activity. Patients will also receive an antibody called CD45 Mab prior to     CTL infusion in order to allow for better expansion of the infused CTLs in the patients.   "
218652|NCT00706329|"     The purpose of the study is to test the use of Deflux injections in a minimally invasive     closure of umbilical (belly button) hernias in infants between birth and five years. The     study is designed to demonstrate that the use of this device can safely and effectively close     an umbilical hernia.   "
218653|NCT00706342|"     The purpose of this study is to determine whether Fostamatinib Disodium is safe and effective     in the treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP).   "
218654|NCT00706355|"     PF-04217903 may work in cancer by blocking the cell growth, migration and invasion of tumor     cells. PF-04217903 is a new member in a class of drugs called c-Met/hepatocyte growth factor     receptor tyrosine kinase inhibitors. This research study is the first time PF-04217903 will     be given to patients. PF-04217903 is taken by mouth daily.   "
218655|NCT00706368|"     Symptoms of vaginitis are common among adolescent females, although studies have shown that     neither experienced clinicians nor patients can accurately diagnose the cause of vaginitis     based on symptoms alone. The purpose of this study is to investigate the accuracy and     acceptability of self-diagnostic methods for vaginitis in adolescent females.   "
218667|NCT00706550|"     The purpose of this study is to evaluate the best timing for administering pneumococcal     vaccine (PV) to HIV-infected adults that have CD4 cell counts of more than 200 and are not     yet receiving combination antiretroviral treatment (ART). Participants in this study will be     assigned by chance to receive vaccination with PV prior to starting ART or after at least 6     months of ART. Antibody levels to components of the PV will be measured at 6 months and 12     months after vaccination. The results will tell us if patients that receive PV after 6 months     of ART have better response to the vaccine than those that get vaccinated prior to treatment.   "
218668|NCT00706563|"     This study is designed to test the immunogenicity and reactogenicity of the     Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for     the 2008-2009 season.   "
218678|NCT00706693|"     The purpose of this study is to determine the most effective treatment option for managing     naturally occurring hypoglycemia in children with type 1 diabetes.      Hypotheses:        1. Sucrose and Fructose are equally effective as glucose in the treatment of spontaneous          hypoglycemia in children with type 1 diabetes.        2. Children and teens will use a variety of treatment practices for the management of          hypoglycemia.        3. Children and teens will prefer the mode of treatment that was most effective in treating          hypoglycemia.   "
218656|NCT00706381|"     Postprandial thermogenesis, or thermic effect of food are terms that describe the increase in     utilization of energy by the human body following a meal. The mechanisms involved in this     process are believed to differ according to the type of food consumed, whether fat, protein     or carbohydrate.      The bile acids (BAs), unique substances secreted by the gall bladder into the gut after a     meal, play an important role in the absorption of fat and the management of cholesterol     stores in the body. Recent studies suggest that BAs may also serve as regulators of energy     expenditure (consumption) in the cells of our body by increasing the production of T3, an     active form of thyroid hormone. T3 in turn is believed to increase the efficiency with which     our bodies burn calories thereby generating heat. Although this process has been shown to be     effective in rodents who demonstrated weight loss after treatment, the role of BAs in humans     is poorly understood. Thus we do not know whether endogenous (produced by the body) or     exogenous (taken as medication) BAs play a significant role in the maintenance of body     weight. We hypothesize that, similarly to rodents, humans will respond to BAs by increasing     energy expenditure via the production of the active form of thyroid hormone.      This randomized, cross-over study will look at changes in thyroid hormones and energy     consumption in response to stimuli of endogenous BA secretion including dietary content, and     to the intake of pharmacological doses of bile acids.      Following a two-day period of equilibration diet, 30 healthy volunteers will be randomly     assigned to receive either a high-fat or high-carbohydrate isocaloric meal followed by a     6-hour metabolic chamber stay; the next day they will be crossed-over to the alternate     intervention. During the following three days, the study subjects will again be randomized to     receive either an intravenous injection of sincalide (the C-terminal octapeptide fragment of     cholecystokinin) 0.04 mcg/kg or placebo and P.O. placebo, or I.V. placebo and 15 mg/kg of BA     (ursodiol) with similar metabolic chamber stays and cross-over design.      The following parameters will be recorded and compared to placebo:      Energy expenditure      Substrate utilization      Spontaneous movements      Skin and core temperature      Serial changes in circulating thyroid hormones      Serial changes in bile acid serum concentrations      The data gathered from this study will provide greater insight into the physiological and     molecular mechanism(s) regulating the relation between endogenous bile acid secretion and     energy metabolism in response to meals, as well as the role of BAs per se on energy     metabolism.   "
218657|NCT00706394|"     Study of anatomical fixation with a 34mm proximal extension   "
218658|NCT00706407|"     The purpose of this experiment is to confirm the results of previous testing of Urodynamix's     Uro-NIRS device. Together Urodynamix and Laborie have created a device that includes standard     Laborie medical equipment and the experimental Urodynamix device. Collectively this     integrated device is considered an investigational device, and the results from this study     may be used to support a submission to the US Food and Drug Administration for the approval     of the integrated device.      This research is being done because we want to test the ability of the integrated Laborie and     Urodynamix device to provide a non-invasive method to provide additional information to     assist with the diagnosis of or treatment plan of patients suffering from urinary problems.     The current technologies rely solely on the measurement of internal pressures of the bladder,     which involves the insertion of catheter into the subject's urethra.   "
218659|NCT00706420|"     The purpose of this study is to evaluate the safety and effectiveness of islet cell     transplantation alone (ITA) in patients with difficult to control type I diabetes. Difficult     to control type 1 diabetes is defined as wide swings in blood glucose that disrupt the     patient's life and result in frequent episodes of low blood glucose despite the proper use of     standard insulin therapy and frequent blood glucose monitoring.   "
218856|NCT00715793|"     The combination of TMZ and DAC may effect dual modulation of DNA repair genes resulting in     improved clinical response.   "
218661|NCT00706446|"     This study is looking at the effects of certain long-acting bronchodilators on patients with     asthma who have specific genetic variations. The investigators are interested in a certain     common genetic variation in the receptor for beta-agonists, which is found in as many of     one-sixth of the population. There is evidence that patients with asthma who have this     variation may not do as well when treated with albuterol on a regular basis. The     investigators will be looking at whether patients with this variation have more asthma     exacerbations over the course of a year when treated with salmeterol or formoterol, which are     long-acting forms of albuterol; and whether these patients have fewer exacerbations when     treated with tiotropium, which is a different long-acting bronchodilator that does not act at     this receptor. In both groups patients will also be receiving inhaled steroids.   "
218662|NCT00706459|"     In this study, we will use advanced and newly available MR imaging techniques at 3 Tesla     (including in situ axial loading and quantitative T1rho, T2, and diffusion measurements) to     assess the intervertebral discs and adjacent vertebrae in patients with lumbar back pain     scheduled for back surgery (n=20), patients with degenerative disease without classic     discogenic back pain (n=10), patients who had discectomies for herniated discs (n=5), and     age-matched volunteers without back pain (n=10). In all patients standard imaging procedures     will also be performed, including radiographs, standard MRI at 1.5 Tesla and discography. All     patients will have specimen of the intervertebral disc harvested at surgery and pathologic     analysis and spectroscopy of these specimen will be performed. Post-surgical findings/outcome     combined with discography will serve as a standard of reference for the identification of the     painful disc(s). The diagnostic performance of the new techniques in assessing the painful     disc will be evaluated. We will collect disc specimens from 50 patients undergoing back     surgery but did not have pre-surgical MR imaging. These disc specimens will be analyzed in     the same manner as the specimens collected from surgical patients who had pre-surgical MRI.     This study will serve as a pilot study for a larger project focusing on advanced imaging of     the painful intervertebral disc.      We hypothesis that advanced, dedicated MR examinations at 3T can identify painful degenerated     discs in patients with chronic lumbar back pain.   "
218663|NCT00706485|"     The purpose of this clinical trial is to determine the feasibility of the Y-90 plaque     applicator. The Y-90 plaque application is designed to deliver high doses of radiation to     tumors in the spine that involve dura (the tough outer layer of the spinal cord). Tumors in     the spine need a high dose of radiation to kill cancer cells. The nearby spinal cord is a     sensitive area which does not safely tolerate high doses of radiation. The Y-90 plaque     applicator is a special technique used to deliver the radiation dose to the tumor cells and     avoid the spinal cord.   "
218664|NCT00706498|"     A study to investigate the activity of BI 2536 in Prostate Cancer   "
218665|NCT00706511|"     The purpose of this study is to look at the metabolic (use of energy) and hormonal features     of sleep problems in men and women.   "
218666|NCT00706537|"     CP-945598 is a potent and selective Cannabinoid-1 (CB1) receptor antagonist currently being     developed for the treatment of obesity. CP-945598 is also being considered as a potential     treatment for non-alcoholic steatohepatitis (NASH). This study will investigate the     steady-state safety, toleration and pharmacokinetics of multiple oral dose administration of     CP-945598. Results will be used to estimate the pharmacokinetic characteristics in NASH     patients and underwrite the safety of this compound prior to any further studies in NASH     patients.   "
218669|NCT00706576|"     Hepatocellular cancer, one of the world's most deadly tumors, is associated with chronic     liver injury and cirrhosis. With the increasing occurrence of viral hepatitis, the incidence     of this cancer in the United States continues to rise. Surgical resection offers the only     hope for cure; but sadly, few patients are candidates for surgery due to their liver disease.     Liver transplant can be an effective treatment, but due to a scarcity of organs, most     patients do not qualify for this therapy either. Patients who are not candidates for these     procedures have very few therapeutic options as chemotherapy and radiation have little     efficacy. New therapies are desperately needed.      Opioid Growth Factor (OGF) inhibits the growth of a number of cancer lines in vitro by a     receptor-mediated mechanism. In pancreatic cancer this phenomenon has been well defined not     only in vitro but in animal models. Based upon these findings, a phase I trial has been     conducted demonstrating that OGF can be administered safely to patients with pancreatic     cancer. The investigators hypothesize that administration of OGF will inhibit the course of     cancer progression in human subjects with unresectable hepatocellular cancer and cirrhosis.     As a first step in testing this hypothesis, the investigators propose a phase I trial to     study the toxicity and pharmacokinetics of this therapy in patients suffering from inoperable     hepatocellular cancer and cirrhosis.   "
218670|NCT00706589|"     The purpose of this trial is to demonstrate the efficacy and safety of aripiprazole in     children and adolescents aged 6~18 years with chronic tic disorders or Tourette's disorder   "
218738|NCT00707512|"     The primary objective of the study is to determine the incidence and pattern of serious     and/or clinically significant infections, malignancies, and other serious adverse event (SAE)     in participants with Crohn's Disease (CD) treated with natalizumab. The secondary objective     of this study in this study population is to evaluate disease severity over time in     participants with CD treated with natalizumab based on changes in the Harvey-Bradshaw Index     (HBI).   "
218880|NCT00716105|"     The purpose of this study is to determine whether infants fed a formula with protein levels     different than a standard infant formula have similar growth and development.   "
218881|NCT00716118|"     Our aims is to document the possible effect of cryo- preservation at the meiotic spindle and     mitochondrial levels.   "
218671|NCT00706602|"     Background: COPD is a systemic illness; morbidity and mortality due to this disease are on     the increase, and it has great impact on patients' lives. Most COPD patients are managed by     general practitioners (GP). GPs base their initial assessment of patients' disease severity     mainly on lung function and then inform patients about adequate treatment. However, lung     function correlates poorly with COPD-specific health-related quality of life and exacerbation     frequency. Preventive cardiology embraced risk index-guided treatment successfully. COPD     disease severity indices that better represent the clinical manifestations of COPD are needed     that can be used to guide risk-stratified treatment.      Objectives: (1) The development and validation of a practical COPD disease severity index to     predict the course of health-related quality of life over time. (2) The validation of the     ADO-Index (Age, Dyspnea, Obstruction) to predict 3-year mortality in COPD patients in primary     care. (3) Link evidence on treatment effects to the COPD risk indices to guide COPD treatment     selection.      Methods: We are in the process of conducting two linked prospective cohort studies with 413     COPD patients (GOLD stages 2-4) from GPs in Switzerland and the Netherlands. We performed a     sound baseline assessment including detailed patient history, lung function, measurement of     exercise capacity and blood sampling. During the follow-up of at least five years, we update     the patients' profile by registering health status, exacerbations and health-related quality     of life and, after 2 years, lung function and measurement of exercise capacity. For aim 1, we     will identify the best combination of variables predicting the course of health-related     quality of life over time using multivariable regression analysis. For aim 2, we will assess     discrimination and calibration of the ADO index to predict 3-year mortality. For aim 3, we     will estimate treatment effects for individual patient profiles using complex statistical     models such as Markov models.      Significance of project: After this study, different risk scores will be available for use in     primary care so that general practitioners can estimate what impact COPD will have on the     patients. By linking these risk scores to evidence form treatment studies, it will be     possible to show for an individual patient how COPD and different treatments impacts on     mortality, symptoms and exacerbations. Thereby, patients and physicians can make more     informed treatment decisions balancing the benefits and downsides of different treatments.   "
218672|NCT00706615|"     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating women with previously treated metastatic breast cancer.   "
218673|NCT00706628|"     The primary objective of this trial is to estimate and compare the 12-week progression-free     rate of BIBF 1120, BIBW 2992 or sequential administration of BIBF 1120 and BIBW 2992 in     patients with HRPC as determined by radiographic, bone and PSA criteria.   "
218674|NCT00706641|"     This pilot study is designed to determine feasibility and safety of treatment with dasatinib     administered orally once daily for 4 weeks duration prior to radical cystectomy for     urothelial carcinoma of the bladder.   "
218675|NCT00706654|"     The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an     intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients     with schizophrenia      The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject     to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole     monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be     stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in     Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are     eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During     Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending     relapse for up to 38 weeks.   "
218676|NCT00706667|"     Study Design: Single-centre, block randomised, blinded, controlled, phase IIIb, parallel     group pilot study.      Primary Objective:      • To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or     without erythropoietin vs. no treatment (standard therapy) on the preoperative anaemia status     in patients undergoing orthopaedic surgery      Secondary Objective:        -  To gain informations for the design of a possible follow-up study        -  To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with          or without erythropoietin vs. no treatment (standard therapy) on pre- and postoperative          Hb levels, iron status, transfusion rate, days until discharge.        -  To evaluate the tolerability and safety of Ferinject®      Study Centres:      This is a single centre study      Patients:      A total of 75 completed patients (50 patients in the intravenous iron treatment groups and 25     patients in the no treatment group will be recruited.   "
218677|NCT00706680|"     This study has been designed to test whether using Thymoglobulin with low dose Cyclosporine     and early steroid dosage reduction will minimize both kidney rejection and the development of     new onset diabetes mellitus after renal transplant.   "
218679|NCT00706706|"     To investigate safety and efficacy of single agent sunitinib malate as first-line systemic     therapy in Chinese patients with metastatic renal cell carcinoma.   "
218681|NCT00706732|"     The objective of this study is to evaluate the safety of the vaccine and the immune response     to the vaccine in healthy adult volunteers 65 years of age or older. Volunteers will be     assigned by randomization to receive either the vaccine or an inactive substance (placebo) by     injections in the arm on two occasions over one month. The study will last approximately 10     months and will have a total of 7 visits.   "
218694|NCT00706901|"     Two approaches for providing evidence-based substance abuse treatment (EBT), group     motivational interviewing (GMI) and the In-Home-Messaging-Device (IHMD), are interventions     that have the characteristic ability for increasing accessibility to evidence-based treatment     among patients with substance use problems and are proposed for investigation. GMI is based     on motivational interviewing, an intervention that has shown consistent significant effects     in promoting treatment retention and reduced substance use among individuals with substance     use disorders, and is delivered in a group format. IHMD is a user-friendly computerized     Tele-mental Health communication tool that allows interaction through the telephone line     between a Veteran and the health care provider in an individual's home or residential     placement. The current proposal aims to determine whether GMI and IHMD lead to a     significantly greater increase in treatment engagement and reduction in alcohol use compared     to a treatment control condition (TCC) among Veterans with a substance use problem and a     co-existing psychiatric disorder.   "
218682|NCT00706745|"     Rationale: Cis-9, trans-11 conjugated linoleic acid (CLA) can protect against the     atherosclerosis development in several animal models. Studies in transgenic mice have shown     that mechanisms might involve beneficial effects on lipoprotein metabolism and insulin     sensitivity and in addition activation of anti-inflammatory pathways. A very limited amount     of human studies have not shown similar beneficial effect of cis9,trans11-CLA on insulin     sensitivity in obese subjects, yet cis9,trans11-CLA did improve the lipoprotein profile in     healthy subjects. The effect of cis9,trans11-CLA supplementation on alternative early     biomarkers of atherosclerosis, like aortic pulse wave velocity, and alternative biomarkers     identified through platelet proteomics, has not been assessed before, and may add valuable     insights into the mechanism of this functional fatty acid in humans.      Objective: To assess the effect of increased intake of cis9 trans11-CLA on development of     atherosclerosis, as assessed with aortic pulse wave velocity and on alternative biomarkers.      Study design: The study is designed as a double blind randomised placebo controlled parallel     group trial.      Study population: 400 men and women, between 40 and 70 years of age, with a body mass index     of 25 kg/m2 or above. Subjects with previous symptomatic vascular disease or diabetes     mellitus and subjects on blood pressure lowering or lipid lowering medication are excluded.      Intervention: Subjects in the intervention arm will receive daily 4 g of CLA oil (2.6 g     cis9,trans11-CLA), 2 capsules to be taken in the morning and 2 in the evening. The subjects     in the control arm receive 4 identical placebo capsules.      Main study parameters/endpoints: The main study outcome is difference between treatment arms     in change in aortic pulse wave velocity after 6 months intervention.   "
218683|NCT00706758|"     In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan     to compare the effects of a structured patient group education (IBS school) with receiving     only written information in the form of a IBS-guidebook. The effects of the interventions on     GI and psychological symptom severity, knowledge and quality of life will be assessed with     validated questionnaires at baseline and 3 and 6 months after the intervention.   "
218684|NCT00706771|"     The investigators will determine the feasibility, safety and efficacy of intravenous sodium     bicarbonate in reducing progression to overt acute renal failure in patients with the     systemic inflammatory response syndrome, and low urine output or early acute renal impairment     as defined by serum neutrophil gelatinase-associated lipocalin (NGAL).   "
218685|NCT00706784|"     This research study is looking at how well a new drug delivery system, called the vaginal     ring, works to get hormones into your body as a form of birth control.   "
218686|NCT00706797|"     To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN)     + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in     subjects with moderate RA who were treated with MTX monotherapy, but continue to have     moderate disease activity.   "
218687|NCT00706810|"     Meningiomas account for 20% of primary adult brain tumors, occurring at an annual incidence     of 6 per 100,000 (Louis, Scheithauer et al. 2000). Complete surgical resection is the     treatment of choice but may not possible when the tumor invades critical structures (e.g.,     skull base, sagittal sinus) (Mirimanoff, Dosoretz et al. 1985; al-Rodhan and Laws 1990;     Al-Rodhan and Laws 1991; Newman 1994; De Monte 1995; Levine, Buchanan et al. 1999; Barnett,     Suh et al. 2000; Ragel and Jensen 2003). Up to 20% of meningiomas exhibit a more aggressive     phenotype that does not respond to standard therapies (Kyritsis 1996). Adjuvant therapies are     critical for patients with this subset of meningiomas. Radiation therapy and stereotactic     radiosurgery are good adjuvant therapies but are limited by radiation neurotoxicity, tumor     size constraints, and injury to adjacent vascular structures or cranial nerves (Goldsmith,     Wara et al. 1994; Barnett, Suh et al. 2000; Goldsmith and Larson 2000). Standard     chemotherapeutic treatments have been disappointing (Kyritsis 1996). Even drugs like     temozolomide that have shown efficacy against malignant brain tumors have failed to inhibit     the growth of refractory meningiomas in a phase II study (Chamberlain, Tsao-Wei et al. 2004).   "
218688|NCT00706823|"     The purpose of this study is to evaluate a new disposable supra-glottic airway device, the     i-gel airway (Intersurgical Ltd., Wokingham, England). We propose to test its ease of     insertion, position within the airway, drain tube patency and anatomic sealing properties     during mechanical ventilation in non-obese anesthetized patients undergoing elective general     surgery. The study device will be compared to the current standard in the industry, the LMA     Unique.   "
218689|NCT00706836|"     The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy     controls to examine the acute effects of certain anxiolytic medications on brain function. In     this case, the medication pregabalin will be used. The investigators hypothesize that     pregabalin (at doses of 50 mg and 200 mg, versus placebo) will yield a reduction in amygdala     and insula activity (in a dose-dependent fashion) during emotion processing using fMRI.   "
218710|NCT00707135|"     The goal of this study is to determine the rapamycin dose equivalent to the recommended phase     II/III dose of temsirolimus and determine the observed toxicities and anti-tumor response of     rapamycin in patients with advanced cancers.   "
218690|NCT00706849|"     The purpose of this study is to determine whether mipomersen safely and effectively lowers     low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial     Hypercholesterolemia (HeFH) and coronary artery disease (CAD) who are already on a stable     dose of other lipid-lowering agents (including maximally tolerated statin therapy).   "
218691|NCT00706862|"     The purpose of the study is to determine whether the combination of talactoferrin,     carboplatin and paclitaxel improves progression free survival and overall survival in     patients with non-small cell lung cancer compared to the combination of paclitaxel and     carboplatin alone   "
218692|NCT00706875|"     The purpose of this study is to collect information on the effects of treatment for     gestational trophoblastic disease (GTD). We plan to use the findings from this study to     better understand GTD survivors' health and quality of life.      We would like to know more about the health, quality of life and pregnancies of women treated     for GTD. This information will be used to try and improve the treatments for women who have     this disease.   "
218693|NCT00706888|"     We put forward that polyphenols and vitamins have a cardiovascular prevention effect for     subject with cardiovascular risk.   "
218695|NCT00706914|"     This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of     aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the     evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs.     formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in     patients with moderate to severe COPD.   "
218696|NCT00706927|"     Glaucoma is one of the most common causes of blindness in the industrialized nations. For a     long time glaucoma has been defined as a disease in which high intraocular pressure (IOP)     leads to irreversible optic disc damage and subsequent visual field loss. However, recent     investigations show that IOP is not the only factor that is involved in the glaucomatous     process leading to retinal ganglion cell death. The role of vascular factors in the     pathogenesis of glaucoma has recently received much attention based on animal experiments and     epidemiological studies. The main focus of glaucoma is still directed towards a decrease in     IOP. There is, however, also considerable interest whether antiglaucoma drugs influence     ocular perfusion. Although measurement of ocular blood flow is still difficult, a number of     innovative techniques have been realized which cover different aspects of ocular perfusion.     In the present study Xalacom® (latanoprost/timolol) and the fixed combination of Combigan®     (brimonidine/timolol) will be compared with respect to their IOP lowering efficacy as well as     their ocular hemodynamic effects.   "
218697|NCT00706940|"     Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months     and during 6-month follow-up after discontinuation of study treatment.   "
218698|NCT00706953|"     The purpose of this study is to evaluate the safety and effectiveness of using pegylated     liposomal doxorubicin and bortezomib in the treatment of patients with relapsed multiple     myeloma who had been previously treated with bortezomib. Multiple myeloma is a cancer that     begins in plasma cells, a type of white blood cell. These cells are part of the immune     system, which helps protect the body from germs and other harmful substances. In time,     myeloma cells collect in the bone marrow and in the solid parts of bone. Multiple myeloma     treatment may include stem cell transplantation, however, not all patients with multiple     myeloma are candidates for stem cell transplantation and many patients who receive     transplants relapse. As a result, additional first and later-line therapeutic options are     needed for patients who are not candidates for transplantation, or whose disease relapses     after transplantation or other therapies. Pegylated liposomal doxorubicin in combination with     bortezomib is approved for the treatment of patients with multiple myeloma who have not     previously received bortezomib and have received at least one prior therapy. The combined use     of pegylated liposomal doxorubicin and bortezomib in this study is designed to evaluate the     overall response rate and safety in patients with multiple myeloma who have been previously     treated with bortezomib.   "
218699|NCT00706966|"     RATIONALE: Diagnostic procedures, such as MRI and magnetic resonance spectroscopy imaging,     may help in learning how well dutasteride works in patients with benign prostatic hypertrophy     and low-risk prostate cancer.      PURPOSE: This clinical trial is studying MRI and magnetic resonance spectroscopy imaging in     patients receiving dutasteride for benign prostatic hypertrophy and low-risk prostate cancer.   "
218700|NCT00706979|"     A sample of smokers who have no current plans to quit will be recruited for this study and     randomized to one of two intervention conditions:        1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or        2. PQA aided by advice and self-help materials plus nicotine replacement therapy (NRT).      This study will test whether adding free nicotine replacement therapy to brief advice to     undertake a practice quit attempt will motivate more smokers to make a serious attempt to     stop smoking than brief advice without NRT. All treatments and assessments will be delivered     via telephone and mailing. The primary outcome of interest is the incidence of a serious     attempt to permanently stop smoking made over a six-month study period.      Our specific hypotheses are as follows:      Hypothesis 1: Helping smokers to make a practice quit attempt aided by NRT will result in a     higher incidence of making a serious effort to quit smoking permanently, compared to an aided     practice quit attempt without NRT. We also expect provision of NRT will increase point     prevalence abstinence at 6 month follow-up.      Hypothesis 2: This relationship between NRT-aided practice quit attempts and quit behaviors     will be mediated by a) increased smoking related self efficacy, b) increased belief in the     efficacy of NRT, c) fewer concerns about adverse events of NRT, d) increased social support     for not smoking, and e) less withdrawal distress and craving during the practice quit     attempt.   "
218747|NCT00707629|"     To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years     diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3     years) compared to a group of children matched for age, sex, glycemic control, and diabetes     duration treated with insulin injections. Outcome measures will assess: clinical variables,     cognitive status (intelligence, neuropsychological functioning), academic achievement,     behavior, parenting stress, and quality of life.      It is hypothesized that long term insulin pump therapy initiated during early childhood can     delay the progression of neurocognitive complications of diabetes, decrease parental stress,     and improve school performance and quality of life, as compared to insulin injections.   "
218701|NCT00706992|"     Background:        -  Melanoma antigen recognized by T cells (MART-1) is a gene that is present in melanoma          cells.        -  This study tests an experimental treatment that uses the patient's own lymphocytes (type          of white blood cell), which are specially selected and genetically modified with a gene          called anti-MART-1 transduced cells (F5) to target and destroy their tumor. Some of the          cells are given as an infusion and others are given as a vaccine.        -  The anti-MART-1 F5 cells are currently being studied in other patients in combination          with chemotherapy and IL-2 (aldesleukin) therapy.      Objectives:      -To determine if the anti-MART-1 F5 treatment can improve the immune system's ability to     shrink tumors and to prevent melanoma from recurring.      Eligibility:        -  Patients 18 years of age and older whose melanoma has been removed and are currently          disease-free, but who are at risk for recurrence.        -  Patients who do not have ocular or mucosal melanoma.        -  Patients with tissue type human leukocyte antigens (HLA-A)*0201).      Design:        -  Workup: Patients have scans, x-rays, laboratory tests, other tests as needed and          leukapheresis, a procedure for collecting white cells to modify in the laboratory and          later reinfuse into the patient.        -  Patients are assigned to one of four study groups:             -  Group 1 receives anti-MART-1 F5 cells by 30-minute infusion through a vein on day               0.             -  Group 2 receives anti-MART-1 F5 cells on day 0 followed by injections of MART-1               vaccine, which contains MART-1 and an oil-based liquid called Montanide ISA-51 VG.               The vaccine is repeated on day 30.             -  Group 3 receives anti-MART-1 F5 cells on day 0 followed by injections of low-dose               IL-2 for 5 days (days 0-4).             -  Group 4 receives anti-MART-1 F5 cells on day 0 followed by MART-1 vaccine and               low-dose IL-2 for 5 days. The vaccine is repeated on day 30.        -  Recovery: Patients are monitored closely and given medicines to prevent or treat any          side effects of therapy.        -  Leukapheresis: Patients undergo leukapheresis at 1 and 3 months after therapy to collect          cells to examine the effects of the treatment on the immune system.        -  Follow-up: Patients return to National Institutes of Health (NIH) 35 days after          completing treatment and then at 3 months and every 6 months thereafter for evaluation          with a physical examination, review of side effects, laboratory tests and scans. They          have blood tests at 3, 6 and 12 months after treatment and then once a year after that.          A biopsy may be requested after treatment ends to examine the effects of treatment on          the immune system. All patients return to NIH for a physical examination once a year for          5 years and then complete a follow-up questionnaire for another 10 years.   "
218702|NCT00707005|"     The purpose of this study is to determine the in vitro antibiotic susceptibility patterns of     conjunctival bacterial flora isolated preoperatively from patients undergoing refractive     surgery.   "
218703|NCT00707018|"     Comparison of immobilization in internal versus external rotation after first time anterior     shoulder dislocation.   "
218715|NCT00707200|"     The purpose of this study is to determine the importance of key blood group molecules in the     clinical outcome of Plasmodium falciparum malaria infection in children.   "
218798|NCT00714493|"     The purpose of this study is to assess the effectiveness of treatment in patients with active     rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment     with etanercept or adalimumab in addition to methotrexate.   "
219394|NCT00723008|"     To find out if Cranial Electrotherapy Stimulation is a useful treatment for people who have     been burned and have Post Traumatic Stress Disorder. CES may be helpful in giving relief to     some or all of those symptoms.   "
218704|NCT00707031|"     The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in     comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a period of 24     weeks of treatment, followed by an extension.      The primary objective is to assess the effects of lixisenatide in comparison to exenatide     (Byetta®), as an add-on treatment to metformin, on glycemic control in terms of glycosylated     hemoglobin (HbA1c) reduction (absolute change) at Week 24.      The secondary objectives are to assess the effects of lixisenatide on percentage of patients     reaching HbA1c less than 7 percent (%) or HbA1c less than or equal to (<=) 6.5%, fasting     plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact     of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper     gastrointestinal disorders - quality of life [PAGI-QOL]).   "
218705|NCT00707044|"     Objective: To evaluate the safety and cost-effectiveness of Short Stay Intensive Care (SSIC)     treatment for low-risk coronary artery bypass patients Design: Randomized clinical     equivalence trial Setting: University Hospital Maastricht, the Netherlands Patients: low-risk     coronary artery bypass patients Interventions: 600 patients were randomly assigned to undergo     either SSIC treatment (8 hours Intensive Care) or control treatment (care as usual, overnight     Intensive Care).      Measurements: The primary outcome measures were Intensive Care (IC) readmissions and total     hospital stay. The secondary outcome measures were total hospital costs, Quality of Life     (QoL), postoperative morbidity and mortality. Hospital costs consisted of the cost of     hospital admission(s) and outpatient costs.   "
218706|NCT00707057|"     The purpose of this study is to evaluate the efficacy and safety of multiple doses of     Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of     third molar teeth.   "
218707|NCT00707070|"     It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy     and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis.     PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24     will be the secondary end points. Safety measures will be the monitoring of serum parameters     including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.   "
218708|NCT00707083|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. It is not yet known which     combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.      PURPOSE: This randomized clinical trial is studying the side effects of two combination     chemotherapy regimens and to see how well they work in treating children with newly diagnosed     acute lymphoblastic leukemia.   "
218709|NCT00707122|"     BACKGROUND The association between mortality and hypoalbuminemia has been observed in several     diseases. Nonetheless, the efficacy of albumin on survival in critically ill patients is     controversial. Several meta-analyses have reported either negative, neutral, or beneficial     effects of albumin administration. To clarify this controversy, a large multicenter     prospective study has been performed, comparing the effects of 4% albumin vs. saline for     volume replacement in critically ill patients. Although no difference in the overall     mortality has been observed, a predefined subgroup analysis has shown a trend of longer     survival in septic patients treated with albumin. As fluid replacement has been shown to be     critical in sepsis, and based on both its primary (oncotic) and secondary properties     (anti-inflammatory), it is conceivable that the use of albumin for volume replacement and for     treating hypoalbuminemia may have a beneficial effects on survival of septic patients.      OBJECTIVES Primary objective: to verify whether volume replacement with albumin (treated     group) and its maintenance within plasmatic physiologic range (equal or above 30 g/l)     improves survival of patients with severe sepsis of septic shock, as compared to crystalloids     (control group). Secondary objectives: to verify the differences in organ dysfunctions,     hospital and intensive care unit (ICU) length of stay between the treated and control group.      METHODS About 1350 patients with severe sepsis or septic shock will be randomized to receive     either albumin or crystalloids as fluid therapy. Volume replacement will be performed for     both groups according to the early-goal directed therapy. Treated group will receive 60 gr     albumin infusion after randomization, and 40-60 gr albumin daily infusion to maintain serum     album level equal or above 30 g/l. Control group will receive crystalloids for the entire     study; albumin administration will be allowed only when daily serum albumin level will be     lower than 15 g/l. Patients will be treated until the 28th day after randomization or until     ICU discharge, whichever comes first.      EXPECTED RESULTS Primary outcomes: absolute risk reduction of overall mortality of 7.5% at     28th day, with a further control at 90th day, following randomization. Secondary outcomes:     reduction of number and severity of organ dysfunctions (as assessed by the Sequential Organ     Failure Assessment score), reduction of ICU and hospital length of stay.   "
218711|NCT00707148|"     The purpose of this study is to look at the safety and immunogenicity of a combination     vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis     (Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety of     the newborn infant and the effect of the mother's vaccination on the infants' immune     responses prior to vaccinating infants with another combination vaccine to protect against     diphtheria, tetanus, and pertussis will be evaluated. Participants will be 18-45 years old.     Pregnant volunteers will be 30-32 weeks pregnant and at a low risk for pregnancy     complications. Pregnant volunteers will receive 2 injections (1 vaccine and 1 placebo,     inactive substance); non-pregnant volunteers will receive 1 injection of vaccine. Blood     samples will be collected from the mother and infant, along with the baby's growth     measurements. Participation for mother infant pairs is about 15 months and about 7 months for     non-pregnant women.   "
218712|NCT00707161|"     The study is a prospective phase II trial of radiation therapy concurrent with cisplatin     chemotherapy in the treatment of locally advanced or metastatic melanoma in patients who are     deemed to require radiation therapy by treating physicians for purposes of local control or     palliation. Eligibility criteria include pathologically confirmed melanoma. Patients will     undergo radiation therapy (20 treatments of 2.5 Gy for a total of 50 Gy) concurrent with     cisplatin chemotherapy.   "
218713|NCT00707174|"     This study is designed as a randomized, prospective study to test the efficacy of imiquimod     plus tazarotene in the treatment of LM. Eligible and consented patients will be randomized to     one of two treatment groups: 1) topical imiquimod group, or 2) topical imiquimod combined     with topical tazarotene group. All patients will undergo a staged surgical excision with rush     permanent sections to confirm negative histologic margins. This will be followed by a     surgical repair of the defect and long-term follow-up of five years to rule out recurrences.     Both groups will have a polygonal excision using 2mm margins per stage.   "
218714|NCT00707187|"     Purpose of the study is to evaluate the effectiveness and safety of a new investigational     dur, IC351. Study is designed to gather information regarding the possible usefulness of     IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud     phenomenon as well as the vaginal dryness and discomfort associated with scleroderma   "
218716|NCT00707213|"     Patients must be currently treated at the Huntsman Cancer Institute or Intermountain Primary     Children's Medical Center to be eligible for this study.      Although there have been many advances in the assessment and treatment of infections     responsible for febrile neutropenia in cancer patients, it still remains a common     complication of cancer therapy and accounts for the majority of chemotherapy-associated     deaths. This National Cancer Institute (NCI) funded proposal using the R-21 Quick-Trials     Exploratory Grant mechanism is to conduct an exploratory/pilot project in a group of patients     with persistent febrile neutropenia to provide critical information that will support the     concept, and aid in the design, of a larger multi-center clinical trial. The ultimate goal of     our interdisciplinary team of oncologists, infectious diseases experts, imagers, and     biostatisticians is to conduct a prospective, multi-center trial to establish the utility and     cost-effectiveness of PET/CT using the widely available glucose analogue     [18F]fluoro-2-deoxy-D-glucose (FDG) in identifying sites of infection in cancer patients with     persistent febrile neutropenia without an obvious identifiable source thus improving targeted     therapy.   "
218717|NCT00707226|"     After focusing many years only on intraocular pressure (IOP) as the primary risk factor,     recently the impact of ocular blood flow is getting more consideration for the     pathophysiology of glaucoma. The circadian change of intraocular pressure (IOP) is well     investigated, but diurnal variations in ocular blood flow are yet to be evaluated, especially     in glaucomatous eyes.      This study is performed to investigate circadian variation of ocular blood flow assessed by     laser interferometric fundus pulsation amplitude (FPA) and laser Doppler flowmetry (LDF) in     glaucomatous eyes during topical antiglaucoma therapy at 8:00, 12:00, 17:00 and 21:00, to     compare these circadian variation of ocular blood flow in glaucomatous eyes with variations     in healthy eyes and to relate blood flow variations with IOP variations.   "
218718|NCT00707239|"     This study will compare the safety and efficacy of a tigecycline regimen versus an     imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with     hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have     ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and     compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from a     minimum of 7 & up to 14 consecutive days, the exact duration will be at the decision of the     investigator based on the subject's condition. Additional protocol specified antibiotics may     be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit will     be done 10 to 21 days after the last day of therapy. The total duration of subject     participation will be between 17 and 44 days, including a follow up period of 30 days after     the last day of therapy for SAEs.      Subjects will be followed for safety and efficacy. The safety assessment will include:     physical examinations, vital signs, assessment of the clinical signs and symptoms of     pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology,     serum chemistries, and coagulation parameters, & a serum or urine pregnancy test before study     entry for women of childbearing potential. The clinical and microbiological efficacy will     both be evaluated.   "
218719|NCT00707252|"     The purpose of this study is to study if the addition of the green tea extract, Polyphenon E,     to Erlotinib is safe and if it has potential to improve outcomes in second line therapy for     Advanced Stage IIIb/IV Non-small cell lung cancer.   "
218720|NCT00707265|"     The purpose of this study was to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System as a     method of facilitating spinal fusion in patients with degenerative disc disease.   "
218748|NCT00707642|"     The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in     healthy adults.   "
218749|NCT00707655|"     The purpose of this study is to investigate the safety of zalutumumab in combination with     radiotherapy as the treatment of patients with head and neck cancer who are not eligible for     platinum based chemotherapy.   "
218750|NCT00707668|"     This is an observational study on the prevalence and incidence of diabetes and osteoporosis     in a rural area of Korea.   "
218751|NCT00707681|"     To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients     using European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30     questionnaire.   "
218721|NCT00707278|"     The study is a prospective phase I trial of radiation therapy concurrent with capecitabine     and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma.     Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the     pancreas that is surgically unresectable. Patients will undergo radiation therapy (28     treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin     chemotherapy. The primary objective of the study is to determine the maximum tolerated doses     of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy     with or without surgery in this patient population.      Secondary objectives of the study are to determine the tumor response rate, survival rate,     local control rate and the rate of distant metastases following capecitabine, oxaliplatin,     and radiation therapy with or without surgery and to determine the rate at which patients     with unresectable disease become resectable.   "
218722|NCT00707291|"     The goal of this study is to look at contact lens on the eye and its interaction with the eye     during wearing.   "
218723|NCT00707304|"     The purpose of this study is to determine whether talactoferrin can improve overall survival     in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two     or more regimens.   "
218724|NCT00707317|"     Until recently, the tuberculin skin test (TST) was the only available diagnostic assay for     detection of latent infection with M. tuberculosis (LTBI). Despite the low overall incidence     of symptomatic tuberculosis infection in low-prevalence countries, the potential mortality     and morbidity mandate constant vigilance to identify patients at risk for reactivation. Due     to systemic immunosuppression, immunocompromised patients with latent M. tuberculosis     infection are at increased risk of progression to active disease. This applies to patients     with various causes of immunodeficiency such as HIV-infected patients, allogeneic stem cell     and solid organ transplant recipients, patients with rheumatoid arthritis and patients with     chronic renal failure. Therefore, current guidelines aimed at preventing tuberculosis     infection in immunocompromized individuals recommend a generalized screening for evidence of     latent infection to target appropriate preventative prophylaxis. At present, tuberculosis     control programs exclusively rely on the tuberculin skin test to identify a latent infection     in asymptomatic individuals.      Recently, novel in vitro assays termed T cell interferon-gamma release assay (TIGRA) have     become available that are based on the detection of interferon-gamma (IFN-gamma) production     in T cells or supernatants after stimulation with highly specific antigens of M.     tuberculosis. Two TIGRA are commercially available, the ELISPOT based T.SPOT.TB and the ELISA     based QuantiFERON-TB Gold test (now available as an IN-TUBE version).      The aim of the study is a prospective comparison of the two commercially available approved     TIGRA (QuantiFERON-TB Gold In-Tube and T.SPOT.TB) with the established Mendel-Mantoux     skin-test in immunocompromized patients (main focus on sensitivity and specificity).      The study hypotheses are as follows:        1. In immunocompromised patients, the two commercially available approved TIGRA          (QuantiFERON-TB Gold In-Tube and T.SPOT.TB) have increased sensitivity and specificity          as compared to the established Mendel-Mantoux skin-test.        2. Results from QuantiFERON-TB Gold In-Tube and T.SPOT.TB do not differ in          immunocompromised patients.   "
218725|NCT00707330|"     The purpose of the study is to examine whether Klacid® (Clarithromycin) will induce oxidative     stress (stress from oxygen) in healthy subjects. This is done by measuring the content of a     particular substance in the urine sample, which is released when the body is exposed to     oxidative stress. In addition, there will also be taken blood samples, which is analysed for     another substance that is indicative of oxidative stress.   "
218737|NCT00707499|"     The purpose of this clinical research study is to learn the safety and biodistribution of     BMS747158 in normal, healthy volunteers.   "
218726|NCT00707343|"     Despite significant advances in the understanding of brain tumor biology and genetics as well     as improvements in surgical techniques, radiotherapy administration, and chemotherapy     methods, many primary brain tumors remain incurable. Most primary brain tumors are highly     infiltrative neoplasms, and are therefore unlikely to be cured by local treatments such as     surgery, focal radiotherapy, radiosurgery or brachytherapy. A particularly problematic aspect     of the management of patients with brain tumors is the eventual development of enhancing     lesions on MRI after radiation therapy. The treating physician is then left with the dilemma     of what this enhancing lesion may represent (radiation necrosis versus recurrent tumor). The     differential diagnosis is between recurrent tumor or radiation necrosis however the amount of     each contributing to the enhancing mass on MRI is difficult if not impossible to assess. This     particular problem is very common and most patients develop some degree of radiation necrosis     after therapy with radiation. Differentiation of necrosis from recurrence is particularly     challenging. MRI is typically unable to make this important distinction as there is simply an     enhancing mass, the etiology of which could be either necrosis or recurrence. Other imaging     methods such as FDG-PET have been used but this technique is also complicated in that the     normal brain has FDG uptake and it is often difficult to differentiate recurrence from     necrosis. [F-18]FLT may prove to be the most reliable method in making this important     differentiation (necrosis versus recurrence) as normal brain and necrotic brain do not have     proliferative activity and thus no [F-18]FLT uptake whereas tumor will have proliferative     activity and thus [F-18]FLT uptake.   "
218727|NCT00707356|"     The aim of this clinical study is to determine the optimal treatment conditions to achieve     prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in     patients with localized prostate cancer.      The secondary objectives is to evaluate safety and quality of life ; to assess the     pharmacokinetic parameters and to model the relationship between concentration and effects;     and to assess the effects, the safety and quality of life of a second WST11 VTP treatment in     patients with persistent or recurrent localized prostate cancer after a first VTP;   "
218728|NCT00707369|"     The purpose of this study is to determine the size of the benefit of an adjunctive empiric     antibiotic therapy compared to standard mechanical debridement and oral hygiene instructions     in a representative sample of German periodontitis patients.   "
218729|NCT00707382|"     The purpose of this study is to determine whether genotyping for CYP2D6 and 2C19     polymorphisms or intense clinical monitoring of treatment and adverse effects improves the     antipsychotic treatment in patients with schizophrenia. This study is designed as a     three-armed prospective randomized controlled clinical trial and includes 300 patients with     schizophrenia. Patients are followed for a period of one year.      During the study period the following effect measures are registered:        -  Time to discontinuation of all antipsychotic medications        -  Number of changes in medication dose        -  Number of changes in medication        -  Compliance (patients´ adherence to medical treatment)        -  Clinical symptoms        -  Adverse effects   "
218730|NCT00707408|"     This is a multicenter open-label phase II trial of high dose imatinib mesylate in patients     with AML in first or second relapse, or with refractory disease. Daily dosing of imatinib 600     mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day     imatinib is permitted for 2 additional months in the event of response failure. Response is     assessed after 1, 2 and 3 months of treatment by bone marrow aspirate.   "
218731|NCT00707421|"     Antiglaucoma medication have been shown to induce subclinical conjunctival inflammation in a     considerable proportion of glaucoma patients. Today, trabeculectomy still remains the gold     standard as surgical treatment of medically uncontrolled glaucoma disease. However, this     procedure is associated with variable possible complications, of which subconjunctival     fibrosis is the most frequent one. The latter results in a non-functional filtering bleb. As     a consequence, either additional interventions such as laser suture lysis, needling, bleb     revision or additional IOP-lowering medication is necessary. Previous studies demonstrated a     benefit of the use of topical steroids postoperatively in reducing inflammation and     subsequent subconjunctival fibrosis. In this perspective, we will prospectively explore the     usefulness of topical NSAID or corticosteroid therapy preoperatively as compared to placebo     in subjects scheduled for first-time trabeculectomy, without interrupting topical     antiglaucoma therapy. This will allow us to determine wether the impact of longterm topical     antiglaucoma therapy on subclinical conjunctival inflammation which possibly result in     postoperative fibrosis and bleb failure can be reversed by anti-inflammatory medication     before filtering surgery.   "
218732|NCT00707434|"     The goal of this clinical research study is to learn if The Guardian® blood-sugar monitoring     device can be used reliably in patients with high blood sugar who are receiving care in the     ICU. Researchers will compare blood-sugar measurements from the study device with blood-sugar     measurements from the standard fingerstick method of blood-sugar testing. This is being     done to see if the new device can accurately measure blood sugar.   "
218733|NCT00707447|"     A type 2 diabetes prevention programme, named PREDIAS was developed. It consists of 12     lessons delivered as group sessions. Die efficacy of PREDIAS was studied in a randomized     controlled study with 12 month follow up. Control group received written information about     diabetes risk. Primary outcome variable was weight reduction at 12 months follow up.     Secondary variables were impact of the intervention on glycemic parameters, lipids, eating     and exercise behavior and other metabolic risk factors   "
218734|NCT00707460|"     The purpose of this study is to evaluate whether or not a traditional First Nations diet     (high protein) and/or a dietary intervention based upon current Canadian dietary     recommendations (high carbohydrate/high fiber) effects risk factors for type 2 diabetes     mellitus and/or cardiovascular disease in a remote fly in First Nations community (Sandy Lake     First Nation).      This pilot has been developed in conjunction with Sandy Lake First Nation to answer the     research question: Will a traditional diet or a diet based upon current Canadian dietary     recommendations result in decreasing risk for type 2 diabetes in Sandy Lake?   "
218735|NCT00707473|"     The goal of this clinical research study is to learn if docetaxel, 5-fluorouracil, and either     cisplatin or carboplatin in combination, then followed by chemoradiotherapy is effective in     controlling cancers of the paranasal sinuses.   "
218736|NCT00707486|"     The purpose of this study is to determine if the HemCon Dental Dressing is effective in     stopping bleeding during dental surgeries.   "
218739|NCT00707525|"     There is a considerable concern about the effects of controlled ovarian hyperstimulation     (COH) for In Vitro Fertilization- Embryo Transfer (IVF-ET) on embryo quality and on the     incidence of chromosomal abnormalities in oocytes and embryos.      The main question remaining is if COH may increase the aneuploidies rate in young and healthy     women. Therefore, the primary endpoint of the present study is to analyse the incidence of     chromosomal abnormalities in this group of patients (oocyte donors), either in oocytes     obtained after a natural cycle or in those retrieved after a COH cycle. To get rid of the     male factor influence, donated sperm will be used.   "
218740|NCT00707538|"     The purpose of this clinical research study is to learn the biodistribution of injection of     BMS747158 at stress and assess the safety of two doses of BMS747158   "
218741|NCT00707551|"     The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is     handled by the body, i.e the absorption, distribution, metabolism and excretion, when     administered in combination with AZD1305.   "
218742|NCT00707564|"     The purpose of this study is to determine if the HemCon Dental Dressing is effective in     stopping bleeding during dental surgeries in patients taking anticoagulant medications.   "
218743|NCT00707577|"     This research study is being done: 1) to determine if the MGH Be Fit program helps employees     to change their nutrition and exercise habits and lower their risk for chronic diseases, such     as heart disease and diabetes and 2) to determine if a maintenance program following the Be     Fit 12 week program will help employees to keep the positive health changes.   "
218744|NCT00707590|"     To assess the safety and tolerability and the PK/PD relationship of BMS-767778 administered     as single and multiple oral doses in healthy subjects, and in subjects with T2DM   "
218745|NCT00707603|"     Chronic hepatitis C (CHC) is among the commonest chronic infectious disease in Australia with     >200,000 exposed persons. Amongst non-infectious chronic conditions- Type 2 diabetes, obesity     and heart disease are extremely common. This study will examine the relationship between     insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to     CHC   "
218746|NCT00707616|"     Type 2 diabetes is a common metabolic disorder arising from a complex interaction between     genetic predisposition and the environment. The development of this disorder is preceded by     impaired glucose tolerance and elevated fasting glucose which also carry adverse     cardiovascular risk. To date a few common genetic variants have been reliably associated with     predisposition to type 2 diabetes. However, it is uncertain how these genes interact to alter     insulin secretion and insulin action prior to the development of type 2 diabetes. We propose     to utilize an established population-based cohort to determine how common genetic variants     associated with type 2 diabetes alter the response to an oral glucose challenge in people     without overt type 2 diabetes. This will enable us to understand how common variants alone or     in combination alter whole-body glucose physiology and predispose to type 2 diabetes.   "
218752|NCT00707694|"     We believe extreme longevity is due to specific genes which function to delay aging and     prevent disease. The purpose of our research is to identify the genes/mutations associated     with healthier aging; to understand the biological functions of these genes/mutations; and to     develop therapies to replicate these preservative genetic activities in individuals who do     not have the genetic profile for longevity.   "
231039|NCT00876486|"     Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in     subjects with recurrent or metastatic breast cancer.   "
218753|NCT00707707|"     This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination     with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative     breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study     to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to     be used in the randomized Phase II part. The safety and tolerability of AZD2281 in     combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5     countries will be enrolled in Phase I.   "
218754|NCT00707720|"     The Barosense Trans-oral Endoscopic Restrictive Implant System (TERIS) is an investigational     system being evaluated for safety The system uses endoscopic guidance to trans-orally implant     a restrictive reservoir for food entering the stomach in obese and morbidly obese subjects to     induce early and prolonged satiety. The Intended Use of the system is for the treatment of     obesity.   "
218755|NCT00707746|"     The purpose of this study is to determine safety and efficacy of mipomersen (ISIS 301012) in     the reduction of total cholesterol, low density lipoprotein cholesterol (LDL-C), and     apolipoprotein B (apoB) in high risk subjects intolerant to statins.   "
218799|NCT00714506|"     This research study will assess the effects of two different programs on weight, body     composition, mobility and improved health. Measures of health will include functional     abilities, and physical performance. The 2 programs being tested will be provided the same     physical activity program which will include aerobic activity and resistance (weight)     training. The intervention study will last up to 1 year with follow-up at 6 months and yearly     phone calls thereafter.   "
219931|NCT00731926|"     oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance   "
218756|NCT00707759|"     The present study investigates the safety and efficacy of steroid withdrawal at six days     post-transplant in pediatric renal recipients under concomitant immunosuppression based on     antibodies anti IL2 (interleukin 2), Tacrolimus (TAC) and Mycophenolate Mofetil (MMF). To     investigate the impact of this protocol in growth, bone metabolism, insulin- sensitivity and     evaluate the expression of IL17 (interleukin 17) and mRNA FOXP3 (messenger ribonucleic acid     forkhead box protein 3) as early markers of acute rejection (blood, urine and renal biopsy).      Hypothesis:Steroid withdrawal in renal pediatric transplant patients improves growth and bone     metabolism without increasing the risk of acute rejection. The expression of FoxP3/IL17 in     urine cells could be an early molecular markers of acute rejection.   "
218757|NCT00707772|"     Hemophilic patients are a known high risk groups for acquiring the hepatitis C. The     surveillance data from Ministry Of Health in IR.Iran had shown that 60% of them are infected     with HCV infection. We are trying the PEGASYS plus Ribavirin in Hemophilic patients with HCV.   "
218758|NCT00707785|"     The purpose of the study is to determine whether vitamin A can improve survival and     facilitate recovery from sepsis and necrotizing enterocolitis in hospitalized neonates.   "
218759|NCT00707798|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of     pneumococcal vaccines in young adults. Subjects will be vaccinated twice with an interval of     two months.   "
218760|NCT00707811|"     Trouble breathing (dyspnea) is a nonspecific symptom associated with many diseases such as     chronic obstructive pulmonary disease (lung disorder in which the flow of air to the lungs is     blocked), asthma, pneumonia, pulmonary hypertension (high blood pressure in the lungs),     congestive heart failure (fluid build-up in the lungs because the heart is not pumping     normally) and pulmonary embolism (blood clot in the lungs). The purpose of this study is to     test two blood markers called ST2 and IL-33. Blood markers are proteins or other compounds in     your blood that physicians use to diagnose different diseases and to determine what the     course of an illness will be. In preliminary research studies, ST2 and IL-33 have been     elevated in patients with a wide variety of diseases where the lungs are the primary organs     involved. This research study will further investigate the ability of ST2 and IL-33 to     predict the severity of disease and the possible use of ST2 and IL-33 in the diagnosis of     various lung diseases.   "
218761|NCT00707824|"     Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in     patient undergoing cesarean section?   "
218762|NCT00707837|"     An evaluation of a preterm infant formula containing ingredients similar to those found in     breastmilk   "
218763|NCT00707850|"     Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis     and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk     for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon     alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.   "
218764|NCT00707863|"     The purpose of this study is to find out what parts of the brain have increased or decreased     activity when people are depressed and how antidepressant medicine changes this activity in     depressed patients. The genetic samples collected are to look at variation in a gene     (serotonin transporter gene), which affects the functioning of the chemical serotonin in the     brain   "
218765|NCT00707876|"     The purpose of this study is to compare the difference between two magnetic resonance imaging     (MRI) techniques for visualizing arteries. The study hypothesizes that one method that relies     upon imaging flowing blood in the pelvic and leg arteries will not be as accurate or     efficient as injecting a safe imaging agent to change the appearance of the blood on the MRI.     Both methods will be compared with Digital Subtraction Angiography (DSA).   "
218766|NCT00707889|"     To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on     disease progression in advanced colorectal cancer.   "
218767|NCT00707902|"     The aim of the study is to show non-inferiority of an echinacea/sage spray compared to a     chlorhexidine/lidocaine-spray in the treatment of acute sore throat during five days of     treatment.      Main outcome parameter is the non-inferiority in number of responders between the two     treatment groups. A responder is defined as a reduction by 50% of the total baseline score     taken prior to treatment start. The symptoms are assessed with a symptom score.   "
218815|NCT00714714|"     A study to compare the skin irritation potential of two marketed gels for acne treatment,     each applied to half of the face of healthy volunteers.   "
218830|NCT00715455|"     The purpose of this study is to determine if it is feasible and safe to use the REG1     Anticoagulation System instead of unfractionated heparin during percutaneous coronary     intervention (PCI) in subjects with coronary artery disease (CAD).   "
218768|NCT00707915|"     Benzodiazepines (BZDs) have been reported to cause negative impacts on motor as well as     cognitive functions, which in turn could result in lethal incidents including falls     especially in the elderly. This notwithstanding, few trials have evaluated a feasibility and     benefits of discontinuing BZD-derivative hypnotics in a systematic manner in this frail     population. In this 8-week open-label study, we examined changes in motor and cognitive     functions following the discontinuation of BZD hypnotics in older persons.      OBJECTIVES & HYPOTHESES        1. Primary Objective The primary objective is to examine the feasibility of discontinuing          BZD-derivative hypnotics in older people.        2. Secondary Objectives             1. One of the secondary objectives is to examine the magnitude of discontinuing               BZD-derivative hypnotics in the stability of body.             2. Another secondary objective is to examine the magnitude of discontinuing               BZD-derivative hypnotics in cognitive function.      Hypotheses      1. More than 80% of the participants will complete and tolerate all the study procedures.      2a. Participants will show an improvement in the stability of body. 2b. Participants will     show an improvement in the cognitive function globally as well as specifically in attention.   "
218769|NCT00707928|"     Primary objective The primary objective of this study is to see whether intravenous (IV) NTG     100-200 microgram can effectively help extract retained placenta as compared to placebo, in a     randomized controlled multicenter study.      Secondary objective is to compare the hypotensive effects of NTG as compared to placebo,     including others side effects such as headache, blood loss, or others.   "
218800|NCT00714519|"     This study will assess if a clinical trial regarding healing of partial thickness wounds can     be executed in nursing homes.   "
218801|NCT00714532|"     This study aims at developing and testing a stage-based scheduled smoking intervention that     targets to encourage smokers to reduce smoking and to facilitate smoking abstinence. We     hypothesize that smokers who receive the staged-based scheduled smoking intervention will be     more likely to report smoking abstinence, quit attempts, and smoking reduction at 12 months.   "
219932|NCT00731939|"     The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.   "
218770|NCT00707941|"     Background In preparation for a global influenza pandemic, there is an urgent need for     representative data from populations and settings where the pandemic is most likely to arise.     There are no data on oseltamivir efficacy from Asian urban slum populations concerning     duration of illness and viral shedding, nor whether efficacy depends on starting treatment <     48 hours or ≥ 48 hours after illness onset. Finally, there are no data on the capacity of the     drug, in such settings, to affect household and community transmission rates.      Aims and Objectives This proposal aims to compare the duration of clinical illness among     patients treated with oseltamivir vs placebo < 48 hours and ≥ 48 hours after illness onset.     It will compare the duration of viral shedding among all treatment groups vs placebo, risk of     transmission to household contacts by treatment group and whether neuraminidase inhibitor use     creates resistance. Secondarily it aims to measure the effect on influenza.      Design and Methods A double-blind placebo controlled clinical trial design among a population     in an urban slum under current influenza disease burden surveillance will be enrolled.     Infection status will be confirmed by rRT-PCR. Patients ≥ 1 year old will be randomised to <     48 hour and ≥ 48 hour treatment arms. Family members and neighbours will also be assessed by     PCR and a basic reproductive number calculated (R0).      Relevance These findings will address whether oseltamivir can affect illness duration and     severity, affect transmission, incidence and resistance in high risk urban Asian settings     where a pandemic is most likely to arise.   "
218771|NCT00707954|"     The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of     TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period     and then 14 consecutive days). Dose escalation design is utilized in this study, and dose     escalation of TA-7284 will be starting with 25 mg (step 1). Subsequent doses of 100 mg (step     2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of     the previous step.   "
218772|NCT00707967|"     This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB     vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.   "
218773|NCT00707980|"     The purpose of this study is to determine the long-term efficacy and safety of vortioxetine,     once daily (QD), in adults with major depressive disorder.   "
218774|NCT00707993|"     The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily     (QD), compared to glipizide in elderly diabetic patients who have not received treatment or     are on a single oral medication.   "
218775|NCT00708006|"     The purpose of this study is to evaluate the safety and tolerability of HGS1029 in subjects     with advanced solid tumors and to determine a phase 2 dose.   "
218776|NCT00708019|"     This study will test two different doses of a psychoeducational intervention to improve     cancer pain management. In addition, the study will determine if the changes in pain     management behaviors that the patients and family caregivers learn continue to be used when     the intervention stops. It is hypothesized that patients and family caregivers who receive     the high dose intervention will have a greater decrease in pain intensity scores.   "
218777|NCT00708032|"     This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens     on the neophyte population.   "
218779|NCT00708058|"     This is a study to determine the feasibility of obtaining information stored in existing     Medtronic internal defibrillators in patients who present to the Emergency Department(ED) for     any reason. In addition, the study will determine if this information is useful to the ED     physician in managing the patient's care, specifically as it relates to heart failure.   "
218780|NCT00708071|"     The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant     with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to     reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).   "
218781|NCT00708084|"     The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in     combination with rabies vaccine compared with human rabies immune globulin (HRIG) in     combination with rabies vaccine in healthy children and adolescents.   "
218782|NCT00708097|"     This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries     lesions in an in situ model   "
218783|NCT00708110|"     GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV     infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging,     placebo-controlled 'proof of concept' study is to be conducted to compare antiviral effect,     safety, tolerability, and pharmacokinetics of GSK1349572 monotherapy versus placebo over 10     days in ART-naïve and experienced, but integrase inhibitor naïve (meaning never having had an     integrase inhibitor) HIV-1 infected adults who are not currently receiving antiretroviral     therapy. This study consists of a screening visit, a treatment period and a follow-up     evaluation. Thirty subjects will be randomized to receive one of three doses of GSK1349572 or     placebo q24h over 10 days. Antiviral effect measures include viral load and CD4 cell count.   "
218784|NCT00708123|"     This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries     lesions in an in situ model.   "
218802|NCT00714545|"     This study is a prospective study of patients treated at Scripps Clinic with intracoronary     brachytherapy for recurrent restenosis within drug eluting stents.   "
218803|NCT00714558|"     The purpose of the study is to compare the pharmacokinetics of fentanyl following i.v. and     oral administration in healthy volunteers, and to assess the bioavailability of fentanyl     following oral administration. Moreover, safety is assessed.   "
218785|NCT00708136|"     The proposed project is a Randomized Controlled study design. Seniors (age >65) willing to     participate in the study will be shortly interviewed to assess eligibility according to the     inclusion-exclusion criteria. The first 60 subjects who upon questioning were judged to meet     the following inclusion criteria:        1. able to stand independently 90 seconds        2. able to walk 10 meters (with cane if necessary)        3. able to understand verbal instructions.      The exclusion criteria will be:        1. Serious visual impairment        2. Inability to ambulate independently (cane acceptable, walker not).        3. Severely impaired cognitive status (score less then 24 in Mini Mental State          Examination).        4. Persons with impaired communication capabilities.      The whole project will be conducted over a period of 24 months. The proposed study is a     randomized experimental intervention/ control group design. A total of 60 elderly volunteer     subjects will be randomly assigned to two groups, exercise group (30) and control group (30).     Twelve training periods will be performed with 8 subjects participating in training during     each period (4 exercise groups). The exercise group will meet on 24 occasions over a period     of 12 weeks (2 times/week).      Gait and balance function will be tested in both groups with well established measuring     techniques before and after the training period. The measuring techniques        1. Medical background variables.        2. Berg Balance Scale.        3. Late life Function and Disability Instrument.        4. Get up and go test - stand up and walk 3 meters turn around and walk back to the chair.        5. Fall Efficacy Scale        6. Fall incidence and fall severity.        7. 6-minute walk test. The control group will not perform any specific balance training          during the 12 week period.      These individuals from control will participate in a separate exercise program after the     training period.      The water training intervention is performed on different levels where each level reflects     different increasing demands on the postural control system. The water exercises also include     perturbation exercises that trigger specific reflex-like balance responses. On each level the     instructor can instantly modify an exercise to be more or less challenging for each     participant.   "
218786|NCT00708149|"     The purpose of this study is to determine whether lansoprazole administered nasogastrically     is effective for stress ulcer prophylaxis in respiratory intensive care unit.   "
218787|NCT00708162|"     The purpose of this study is to compare the safety, tolerability and efficacy of a regimen     containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a     background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or     2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults     who have documented resistance, or at least six months experience prior to screening with two     or more different classes of ARV agents.      Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen     (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to     known drug interactions, participants in the Elvitegravir group receiving RTV-boosted     atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will     receive elvitegravir at a lower dose (85 mg).   "
218788|NCT00708175|"     The purpose of this study is to evaluate the effect of pioglitazone on bone metabolism in     postmenopausal women with impaired fasting glucose.   "
218789|NCT00708188|"     This is a prospective study including acute ischemic stroke patients aged 18 to 90.     Multidetector raw CT is performed in acute ischemic stroke patients. Heart, neck vessels and     brain arteries are studied during the same acquisition. Results are compared with the     standard methods including transesophageal echocardiography (TEE), Doppler ultrasound (DUS)     and MR angiography (MRA) of neck vessels. The main criteria is the ability of CT to classify     the stroke etiology correctly according to the TOAST classification in comparison with the     standard methods.   "
218790|NCT00708201|"     This study is being conducted to determine whether alvimopan can accelerate recovery of     gastrointestinal function following radical cystectomy when compared with a placebo.     Secondary objectives of the study are:        -  to evaluate the effect of alvimopan on hospital length of stay        -  to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related          morbidities        -  to evaluate the overall and cardiovascular safety of alvimopan   "
218791|NCT00708214|"     Progression-free rate after 16 weeks of BIBW 2992 administration in association with     letrozole   "
218792|NCT00714415|"     The purpose of this observational study is to describe the incidence of adverse events among     patients treated with BeneFix® in usual health care settings in Germany.   "
218793|NCT00714428|"     Objectives: The ultimate goal of this research program is to promote seamless, comprehensive     care for Operation Enduring Freedom/ Operation Iraqi Freedom (OEF/OIF) veterans. The purpose     of this study is to develop a psychometrically sound tool to measure health-related quality     of life (HRQOL) applicable to wounded warriors with TBI (deployment-related TBI).   "
218794|NCT00714441|"     To date, there have been few practical, evidenced based interventions that are directed at     patients with Type II Diabetes who are experiencing depressed and/or emotional distress in     primary care settings. This study will (1) combine two existing, evidenced-based,     interventions (a computer automated, diabetes specific self-management program (CASM) vs. a     self-care program plus a live problem solving distress-reduction program (CAPS) vs. a     lifestyle and activities education program (LEAP-AHEAD)) into a practical, 3-arm clinical     trial with a highly distressed multi-ethnic patient sample, and (2) evaluate the intervention     using the RE-AIM framework, sharing the results through a comprehensive dissemination     package.      Hypothesis 1: The combined CASM and CAPS arms will be superior to the LEAP-AHEAD group on the     primary outcomes at follow-up.      Hypothesis 2: The CAPS arm will be superior to the CASM arm on primary outcomes at follow-up.   "
218795|NCT00714454|"     12-week study to compare the efficacy and safety of a course of a twice daily treatment with     APS in the form of a lotion to its vehicle for the treatment of acne.   "
218796|NCT00714467|"     In this study, we choose to specifically recruit Chinese, the largest ethnic group of the     Asian and Pacific Islander community,2 as an initial step to increase our understanding of     the role of family or supportive others in the process of smoking cessation among Asian     Americans. We propose the following specific aims for the study:        1. Examine the effectiveness of proactive recruitment of Chinese smokers into a smoking          cessation treatment program through their family or friends.        2. Test the efficacy of a family assisted intervention using the stages of change approach          in promoting smoking cessation in the context of an expert system intervention.        3. Explore the role of supportive and non-supportive behaviors in relation to both          short-term and long-term smoking cessation outcomes in the presence of the expert system          intervention.   "
218797|NCT00714480|"     This study proposes to examine the effect of TMG therapy upon the cellular elements within     the central (bone marrow) and peripheral (lymph node) lymphoid compartments of humans.     Briefly, bone marrow aspirates and lymph nodes will be obtained at the time of transplant,     from renal transplant recipients receiving TMG induction therapy. For comparative purposes,     peripheral blood samples will also be obtained. Lymphocytes from these compartments will be     assessed for CD antigen expression, apoptosis, cytokine production following memory immune     responses, and functional assays to assess potential regulatory T-cell (Treg) activity.   "
218804|NCT00714571|"     Memory deficits are common after traumatic brain injuries (TBI) and are characteristic of     various forms of dementia, such as Alzheimer's disease and its common precursor mild     cognitive impairment (MCI). This project intends to assess the efficacy of cognitive     rehabilitation in these patient populations. We will also use neuroimaging (functional     magnetic resonance imaging - fMRI) to assess changes in brain activity that occur following     cognitive rehabilitation.   "
218805|NCT00714584|"     The purpose of the study is to compare the pharmacokinetics of naltrexone following i.v. and     oral administration in healthy volunteers, and to assess the bioavailability of naltrexone     following oral administration. Moreover, safety is assessed.   "
218806|NCT00714597|"     The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.]     injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the     primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute     medical illness.      The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026     exposure in this population.   "
218807|NCT00714610|"     The objective of this study is to compare serum chromium and cobalt levels of patients who     have undergone metal on metal total hip arthroplasty. It is unknown if the presence of     bilateral well-functioning large-head metal-on-metal (MOM) total hip arthroplasties (THAs)     leads to higher serum metal ion concentrations than unilateral MOM THA. Elevated levels     (chromium, 17 μg/L; cobalt, 19 μg/L) have been associated with poorly functioning MOM THA     with metallosis. Fourteen patients having undergone bilateral and 25 patients having     undergone unilateral large-head primary MOM THA were compared. Harris Hip Scores, University     of California Los Angeles activity scores, radiographs, serum creatinine, and serum cobalt     and chromium levels were obtained.   "
218808|NCT00714623|"     This study is a prospective, non-randomized, open-label registry of consecutive patients with     CAD treated by stent-assisted PCI using at least one CypherTM stent. Up to 1000 pts will be     included in the registry. The registry is conducted for the evaluation of the impact of     CypherTM Sirolimus-eluting stent implantation in the real world of interventional     cardiology. Informed consent will be obtained from patients meeting the inclusion criteria     before the initiation of any study specific procedures. Consecutive patients treated with the     use of the CypherTM stent will be included in the registry. Baseline and post-procedure blood     samples will be used to perform platelet function analysis using the Accumetrics Ultegra RPFA     (Rapid Platelet Function Assay).      All patients will be followed from enrollment through the hospital discharge for any     clinically significant event (death, myocardial infarction, TLR, TVR, major or minor     bleeding). A follow-up telephone assessment of death, myocardial infarction,     revascularization, and medical treatment will be conducted by experienced research personnel     at 30 days, 6 months, 1 year and at least 2 years. All site reported deaths, myocardial     infarctions and revascularizations will be adjudicated by an independent Clinical Events     Committee for all 1000 patients enrolled in the trial. An interim analysis of the first 750     patients will be conducted and data forwarded to FDA.   "
218809|NCT00714636|"     The purpose of a CSF repository is to collect samples of spinal fluid from controls and     patients with neurologic disorders including but not exclusively ALS, Dementia, CRPS,     neuropathies, and other neuromuscular diseases. This CSF repository will allow the use of CSF     in biochemical studies of various neurologic diseases. It would also provide a supply of the     necessary normal and disease control patients. CSF would be obtained from patients who are     undergoing spinal taps for other reasons including diagnosis, treatment, or participation in     clinical trials. We are proposing to collect an additional < 3 ml of CSF from a lumbar     puncture that is already being performed for diagnostic or therapeutic reasons, in order to     store it in our laboratory for use in future research studies. No lumbar punctures will be     initiated specifically for this protocol.   "
218810|NCT00714649|"     Primary diagnose HNSCC carcinoma patients eligible for curative surgery will be proposed the     addition of 2 or 3 neoadjuvant cetuximab infusions. The main objective is to reduce to a     minimal delay the time elapsing between last infusion and surgery.      Iterative biomarkers will be taken at 6 time points permitting to investigate expression gen     profile and protein mutation.   "
218811|NCT00714662|"     To investigate the influence of different dialysis frequencies on the outcome of end-stage     renal disease patients undergoing chronic hemodialysis therapy.   "
218812|NCT00714675|"     The aim of this study is to evaluate the effects of a supplementation of citrulline for three     weeks in elderly malnourished and hospitalised subjects on muscle protein synthesis.   "
218813|NCT00714688|"     The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release     (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with     attention deficit/hyperactivity disorder (ADHD).   "
218814|NCT00714701|"     CAPS4 is a study at Johns Hopkins Hospital to study the diagnosis and long-term outcomes of     screening patients with an increased inherited risk for pancreatic cancer.   "
218816|NCT00714727|"     The object of this research study is to test a standardized set of acupuncture points on     migraine patients to reduce frequency and intensity of headaches. Acupuncture has been     studied in prior research but the treatment points have varied between subjects, making it     difficult to replicate studies.   "
218817|NCT00714740|"     The purpose of the study is to investigate the effect of acetazolamide as a treatment for     sleep related breathing disturbances in patients with the obstructive sleep apnea syndrome     living at low altitude during a sojourn at moderate altitude   "
218818|NCT00715299|"     This is a research study to examine a new type of walking therapy for people after they have     had a stroke. We will study how people move and how their muscles work to see how the therapy     helps people to walk better and to see how the therapy can be improved.   "
218851|NCT00715728|"     This study will test the hypothesis that an electric heating device, the Hot Dog warming     system is as effective as the Bair Hugger forced air heating system.   "
218852|NCT00715741|"     The purpose of this study is to determine whether breathing high levels of oxygen during     surgery affects oxygen levels after surgery. The second purpose of this study is to determine     whether giving positive end expiratory pressure PEEP and high oxygen together affects     patients oxygen levels after surgery.   "
218819|NCT00715312|"     Rationale: The effect of positional distribution of dietary fatty acids on markers of     inflammation and blood lipids metabolites on diets containing fatty acids such as oleic acid     that are associated with reduced risk of cardiovascular disease is not widely studied.      Hypothesis: There would be difference detected in the concentrations of markers of     inflammation and blood lipid metabolites in human volunteers fed controlled diets.      Study design: A randomized, double-blind, crossover clinical trial that involves 41 healthy     volunteers. The volunteers will be selected based on inclusion and exclusion criteria. They     will consume controlled diets for 5 weeks that provides 15% of energy from protein, 30% of     energy from fat, and 55% of energy from carbohydrates. Volunteers will be assigned to each     test diets which is cooked with novel olein, palm stearin or partially hydrogenated soybean     oil in random order until all three diets has consumed by each person.      Main study parameters: LDL-cholesterol   "
218820|NCT00715325|"     The purpose of this study is to determine whether the ProtectiScope CS is capable to perform     diagnostic and therapeutic colonoscopy.   "
218821|NCT00715338|"     Collect exhaled breath condensates from patients scheduled for a routine surgical procedure     before, during, and after surgery for measurements of IsoFs      Draw blood from patients scheduled for a routine surgical procedure before, during, and after     surgery for measurements of serum thrombomodulin.   "
218822|NCT00715351|"     This trial is conducted in Europe. The aim of this observational study is to evaluate the     glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes     with Levemir® compared to Insulatard® under normal clinical practice conditions.   "
218823|NCT00715364|"     To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke     patients.      To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265,     when compared with patients given a placebo control.   "
218824|NCT00715377|"     Anticholinergic antiparkinsonian agents often cause side-effects including cognitive     impairment, dry mouth, and constipation while they diminish antipsychotic-induced     parkinsonian symptoms. The introduction of second generation antipsychotics (SGA) brought     fewer neurological side effects. However, anticholinergic coprescription rates are still as     high as 12-65% in patients on SGA that are much higher than the incidence of EPS reported in     clinical trials (3-20%). This apparently discrepancy is likely explained, in part, by the     established tradition of routine use of this medications. Older patients are particularly     sensitive to anticholinergic side-effects due to age-related changes in pharmacokinetics and     pharmacodynamics. In this study, we will examine the safety and benefits of reducing the dose     of a frequently prescribed anticholinergics, benztropine, on cognitive function,     extrapyramidal symptoms, and psychotic symptoms in older subjects with a primary psychotic     disorder.   "
218825|NCT00715390|"     To describe the types and incidence of cardiac dysrhythmias that occur under anesthesia in     the present anesthesia environment.   "
218826|NCT00715403|"     The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms     of incidence and intensity of Adverse Events and changes in safety laboratory parameters.      Secondary objectives are the collection of further safety data (vital signs), efficacy data     and the determination of pharmacokinetic characteristics during long-term therapy with BIBF     1120.   "
218827|NCT00715416|"     The investigators evaluated whether primary implantation of a self-expanding nitinol stent     yielded anatomical and clinical benefits superior to those afforded by percutaneous     transluminal angioplasty with optional secondary stenting.   "
218828|NCT00715429|"     1. Research question: Does vitamin D reduce the frequency and severity of nocturnal leg          cramps in older persons who previously took quinine for leg cramps?        2. Experimental Design: This is a randomized, double blind, placebo controlled study of 70          men and women veterans receiving care at the Madison VA Medical Center or at the          University of Wisconsin Hospitals and Clinics. Individuals age 50 or more who have          previously taken quinine for nocturnal leg cramps and meeting baseline criteria are          eligible to enroll. Enrollees meeting laboratory criteria, including low-normal vitamin          D levels, will undergo a 2-week diary run-in period to confirm cramp frequency. Those          who report two or more leg cramps in each week will continue in the study and will be          randomized to vitamin D or placebo. After a two-week wash-in, subjects will take a          vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly          vitamin D (50,000 units) maintenance dose for 7 weeks. Subjects will record by diary the          number and severity of leg cramps from the start of the diary run-in until a week          after the last dose of study drug. Study investigators will call subjects at scheduled          intervals to assess compliance, tolerability, and diary use.        3. Major risks to subjects: No major risks are anticipated. Excessive vitamin D can          increase blood calcium levels (hypercalcemia), with symptoms such as thirst, nausea, and          weakness. However, symptomatic hypercalcemia has not been reported except for those          taking more than 40,000 units daily for several months. This is far above the cumulative          dose in our study.        4. Potential benefits: Subjects may not receive any benefit. Vitamin D may alleviate leg          cramps for subjects who receive it.        5. Consent Procedure: Flyers describing the study and telephone contact information will be          mailed to patients who have received quinine during the period 2002-2007. The PI or          Co-PI will return calls to describe the study and answer any questions. For persons          meeting preliminary (pre-lab) study criteria, two copies of the consent form will be          mailed, with the patient mailing back one signed consent to the PI.   "
218829|NCT00715442|"     The goal of this clinical research study is to learn if Sutent® (sunitinib malate), given     before surgery, can help control renal cell carcinoma. The safety of sunitinib malate will     also be studied.   "
218831|NCT00715468|"     Treatment with MMF often results in adverse GI events, which can lead to dose reductions of     MMF and decreased graft function. Enteric-coated mycophenolate sodium (MYFORTIC*) was     developed as an alternative formulation of MPA to improve upper GI tract side effects. An     improvement in the severity of GI side effects could result in an increased tolerance to MPA     and an improvement in patient quality of life. This study will use the GSRS to evaluate     improvement in gastrointestinal symptoms.   "
218832|NCT00715481|"     Reduced glomerular filtration rate (GFR) has been recently shown to be a powerful predictor     of cardiovascular morbidity and mortality in the general population, independent of     traditional cardiovascular risk factors.      This observational study is aimed at assessing the association of reduced estimated GFR with     cardiovascular morbidity and mortality in a large italian population (at least 15,000     subjects) of type 2 diabetic outpatients over a 4-year follow-up.   "
218853|NCT00715754|"     The purpose of this research is to study whether fetal biometrics obtained by 2-D ultrasound     can predict infant adiposity by air displacement plethysmography at birth.   "
218833|NCT00715494|"     Intensive care unit (ICU) hospitalization saves lives but often does so at a high personal     cost to ICU survivors who frequently experience significant cognitive impairment and an array     of physical and functional disabilities that limit their recovery and quality of life. While     the problems experienced by these patients are likely amenable to rehabilitation, few ICU     survivors receive focused rehabilitation following hospital discharge. The purpose of this     study is to initiate and test the feasibility of a complex intervention incorporating a     cognitive, physical, and functional rehabilitation program at the time of hospital discharge     and implement this 12 week program using in-home visits and tele-technology. We hypothesize     that this interdisciplinary rehabilitation program, initiated at hospital discharge and     implemented using in-home visits and tele-technology, will result in improved recovery of     neuropsychological and physical performance and overall functional status.   "
218834|NCT00715507|"     To assess the clinical utility of the graphical medication monitor, results of the     anesthetics for which the display was present will be compared to the results of the     anesthetics in which there was no display.   "
218835|NCT00715520|"     Enhance motor cortex reorganization with noradrenergic drugs and non-invasive repetitive     transcranial magnetic stimulation.   "
218836|NCT00715533|"     The purpose of this study is to compare clinical and economic parameters of stroke patients     who have received acute MRI imaging (test group) to patients who have received routine CT     imaging (control group) in the clinical setting of acute stroke.   "
218837|NCT00715546|"     The aim of this study is to determine the safety of the autologous transplantation of     adipose-derived stem cells in the treatment of lipodystrophies.   "
218838|NCT00715559|"     The purpose of this study is to determine whether cysteamine bitartrate, an FDA-approved drug     for a non-psychiatric condition, is safe and effective for the treatment of major depression.   "
218839|NCT00715572|"     The objective of this study was to analyze the features of monotherapy with L-T4 in     comparison with combined therapy with L-T4 and L-T3 in patients with primary hypothyroidism.   "
218840|NCT00715585|"     This study examines the impact of certified diabetes education, and the role of different     educational approaches to medical nutrition therapy. in addition the role of patient health     literacy level is assessed   "
218841|NCT00715598|"     The purpose of the study is to improve a questionnaire (the Pain Quality Assessment Scale)     used for measuring different types of pain people may experience. An improved version of this     questionnaire will help researchers better understand the impact of pain treatments on     different types of pain through the use of this questionnaire.   "
218842|NCT00715611|"     For patients with this type of cancer, the standard of care is treatment with chemotherapy.     Radiation therapy is typically not used. This is because radiation to the entire lining of     the lung has many side effects that are often severe including damage to the lung     (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy     (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy.     This type of radiation therapy specifically targets the lining of the lung, where you have     your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is     to test the safety and implementation of standard pleurectomy/decortication (removal of the     surface lining of the lung) performed at other centers. Patients will undergo     pleurectomy/decortication chemotherapy and hemithoracic pleural IMRT to the pleura in     patients with malignant pleural mesothelioma.   "
218843|NCT00715624|"     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in     comparison to placebo, as an add-on treatment to basal insulin with or without metformin over     a period of 24 weeks of treatment, followed by an extension.      The primary objective is to assess the effects of lixisenatide when added to basal insulin on     glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24.      The secondary objectives are to assess the effects of lixisenatide when added to basal     insulin on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal     challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of     patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in     7-point self-monitored plasma glucose (SMPG) profiles, change in basal insulin and total     insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide     antibody development.   "
218844|NCT00715637|"     Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been     extensively studied in patients with malignant solid tumors. Amonafide has also been studied     in patients with AML.      The purpose of this study is to assess the relative efficacy and safety of amonafide in     combination with cytarabine compared to daunorubicin with cytarabine in subjects with     documented secondary AML.   "
218845|NCT00715650|"     This study will address the problem that claimants with psychiatric disabilities who apply     for and receive disability benefits go on to work less than those whose claims are denied.   "
218846|NCT00715663|"     This study is conducted in Asia. The aim of this observational study is to evaluate safety,     efficacy and convenience in using NovoMix® 30 FlexPen® in type 2 diabetes under normal     clinical practice conditions.   "
218876|NCT00716053|"     The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in     treating patients with advanced upper lobe predominant emphysema.   "
218847|NCT00715676|"     This study will evaluate the effect of a 1-year administration of the vitamin D analog     2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density     (BMD), safety, and tolerability.   "
218848|NCT00715689|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone     deficient adults   "
218849|NCT00715702|"     The purpose of the study is to investigate the pharmacokinetics of a single dose of AZD5672     in patients with renal impairment by comparing with healthy volunteers   "
218850|NCT00715715|"     Patients with chronic hepatitis B constantly produce the virus in the body. The disease of     chronic hepatitis B is the body responding to the virus. Use of steroids can adjust this     response. After taking steroids, viral production usually increases and liver function tests     increase. After stopping steroids, viral production usually decreases. Many studies in the     past have studied taking a low dose steroid before treating hepatitis B. Those studies have     shown that low dose steroids help your body to clear the virus. The goal of this study is to     improve the liver function by slowing viral growth.   "
218857|NCT00715806|"     The objective of the study is to determine the ability of open magnetic resonance imaging     (MRI) scanners to reduce claustrophobic reactions, thereby enabling more examinations of     severely anxious patients. The investigators hypothesize that anxiety-based claustrophobia     that prevents MR examinations without sedation can be reduced using an open MR scanner design     thereby improving clinical management of those patients.   "
218858|NCT00715819|"     Stanford University Dermatology Clinics and Lucile Packard Children's Hospital are evaluating     the use of the otoscope for the diagnosis of skin lesions. We are particularly looking for     children and/or adults with nodules, cysts, tumors, or pilomatricomas. The study will take     15-30 minutes and we will use light to examine and take a picture of your skin lesion. There     is no monetary compensation for participating in the study.   "
218859|NCT00715832|"     The study uses a molecule or particle that is found only on cancer cells and is unique to     cancer cells, as it is not detected on normal tissue. The molecule is known as oncofetal     antigen or OFA. Because OFA is unique to cancer, the investigators feel OFA could be used to     educate the patients' own defenses to more effectively fight the cancer on her own, he or she     is harboring. Although investigators found OFA to be present in large concentrations on all     cancers, it was found to be especially abundant in breast cancers. Therefore, the     investigators feel that this molecule would be a good target for stimulating patient defenses     especially against breast cancer cells. To accomplish this, certain defense cells (immune     cells) will be washed out from the patients' blood using a machine to which the patient is     connected through two small cannulas placed into veins located in the patients' arms. Those     cells will be manipulated in the laboratory with artificially engineered OFA. These     reeducated cells will be injected into the skin of patients. There will be a series of     three skin injections in 4 week intervals. It is hoped that this treatment will convert the     patients' defenses to a point that effective anti cancer responses will be induced.     Effectiveness of the treatment will be monitored with blood tests and assessment of the size     of the cancers.   "
218860|NCT00715845|"     The purpose of this study is to determine if blowing carbon dioxide into the surgical field     during open-heart surgery to displace retained chest cavity air from the atmosphere will     decrease the number of microembolic being introduced into the heart chambers and brain.   "
218861|NCT00715858|"     The purpose of this study is to examine the cerebrospinal fluid (CSF) of patients with     Alzheimer's disease for biomarkers of inflammation and their response to the antibiotics     doxycycline and rifampin. The results of this preliminary analysis will be used in defining     the direction of further research.   "
218862|NCT00715871|"     The purpose of this study is to determine whether the Smoke-Break nicotine delivery device     can help smokers quit smoking, while avoiding many of the side effects associated with other     smoking cessation products.   "
218863|NCT00715884|"     The objective of this study is to show similar (non-inferior) safety and effectiveness     between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a     prospective, multi-center, randomized clinical study for the treatment of de novo native     coronary lesions.   "
218864|NCT00715897|"     The aim of the current work was to evaluate, for the first time in a prospective randomized     study, the effect of HBOT on patients with chronic neurological deficiency due to stroke.   "
218865|NCT00715910|"     In this study, the concentration of antibody to the vaccine one year, three and five years     after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine     GSK134612 and Menactra® in a previous study (whose objectives & outcome measures are     presented in a separate protocol posting with NCT number =00454909) will be evaluated. The     safety and immune response to a booster dose of vaccine GSK134612 administered at 5 years     post-primary vaccination and a primary vaccination of a newly enrolled group with GSK 134612     vaccine will also be evaluated.   "
218866|NCT00715923|"     Subjects enrolling into a nutrition study of the effects of tea on fat absorption will be     randomized to receive either a standard informed consent document or a modified document that     is shorter and more easily understood than the standard document. The hypothesis is that     using a shorter form that is more easily understood and more visually simple will lead to     greater subject satisfaction in the consent process and will not compromise subject     comprehension of key study aspects. Consent for study inclusion has been waived by the IRB     because informing subjects of the nature and process of the study would likely affect the     findings, and both the standard and modified consent forms were approved for use in the     nutrition study.   "
218867|NCT00715936|"     The purpose of this study is to evaluate whether the integration of an early child     'stimulation and care for development' intervention, either alone or in combination with an     'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with     infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial     outcomes on child development (cognitive, language, motor and social emotional development)     and child growth.   "
218892|NCT00716261|"     Our hypothesis is that intensive training with positive biofeedback may enhance postural     control and stability in Parkinson's disease patients and in elderly fallers.   "
218868|NCT00715949|"     Brain injuries from trauma are common in children, often resulting in death and disability.     Most brain injuries are minor, yet their treatment can be challenging. Because there are many     different scales used to characterize the severity of brain injury, there is no consensus     regarding how to manage patients with minor brain injuries. Specifically, there is no     agreement on recommendations regarding the safety of return to activities following injury.     In young athletes with minor brain injuries (i.e. concussions) there is strong data     suggesting that return to baseline neurologic function is often delayed by days or weeks.     Children allowed to return to activities too soon may be at a higher risk for a second     concussion, may delay recovery or, in rare cases, die. Researchers have designed a     computer-based testing system (ImPACT©) to objectively test for neurologic deficits following     injury. This test has been used primarily in athletes following a concussion but is also     applicable to children with brain injuries from non-sports related traumas. We propose to     utilize this testing in pediatric patients admitted to the hospital with minor brain injury.     The test would be administered at the time of the hospitalization as well as in the     outpatient trauma clinic at the time of routine follow up. The test would allow us to     determine if there are neurologic deficits, potentially subclinical, in these brain injured     patients and how quickly they recover from their injuries. If successful, the testing will     likely be useful in other clinical settings such as the primary care office (e.g.     pediatrician), specialty care office (e.g. sports medicine), or emergency room to determine     if an injured child requires additional intervention.   "
218869|NCT00715962|"     Low mobility, defined as being limited to bed or chair, is common during acute     hospitalization. This study will evaluate the impact and safety of a hospital walking program     for older patients during acute general medical hospitalization. Participants who are 65     years of age or older, will be randomized to usual care (UC) or to a hospital walking program     (WP), which includes twice daily walks with assistance, provision of necessary ambulatory     devices, and a behavioral intervention strategy designed to encourage out of bed activity.     Throughout hospitalization, the WP and UC veterans will were wireless monitors on the thigh     and ankle that measure activity. The primary goal will be in increase the length of time     veterans spend out of bed and to assure this out of bed activity is safe.   "
218870|NCT00715975|"     The Psoriasis and a chronic dermatosis characterized by abnormal proliferation of cells     epithelial, vessel dilation and inflammation locally, which presents erythematous-scaly     lesions in various areas of the body, preferably in the scalp, region and religious joints as     elbows and knees. It occurs equally in both sexes and can appear at any age, and the mean age     for the onset of the disease and around 27.3 years.      The halobetasol propionate and an ultra-potent corticoid. Its chemical structure and similar     to the Clobetasol corticoid this, until then classified as the most potent corticoid used     worldwide in clinical practice. However, the molecular structure of Halobetasol gives it     increased its activity antiinflammatory and anti-proliferative.      The objective of this study is evaluating the efficacy and tolerability of the drug     Halobetasol propionate cream formulation as a treatment in patients with plaque psoriasis     mild to moderate, compared to the substance of similar power, Clobetasol propionate - Psorex     - Cream.   "
218871|NCT00715988|"     The Primary objectives of this proposal are to determine the population kinetics for     methadone and its enantiomers in preterm newborns and infants at 29 weeks to 48 weeks post     menstrual age (PMA) who are 1 week old and older and establish any correlations of the     kinetics with PMA to determine the bioavailability for enterally administered methadone in     these newborns and young infants.      The secondary objectives of this proposal are to explore possible genotypic changes in     CYP3A4-3A7-3A5, CYP2B6, CYP2C8, CYP2C19, and CYP2D6 and PGO on the kinetics of methadone in     neonates and young infants and to test the safety of methadone in this population by     correlating the plasma concentrations of the methadone enantiomers, S-methadone and     R-methadone, with changes in cardiac repolarization by measurement of corrected QT, heart     rate, and blood pressure.   "
218872|NCT00716001|"     This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the     prevention of contrast-induced nephropathy.   "
218873|NCT00716014|"     Pachyonychia congenita (PC) is a rare, autosomal dominant keratin disorder affecting the     nails, skin, oral mucosae, larynx, hair and teeth. Pathogenic mutations in keratin K6a, K6b,     K16 or K17 act via a dominant negative mechanism, leading to manifestations of the disease.     The most disabling PC symptom is a painful plantar blistering and keratoderma that requires     use of ambulation devices in more than 50 percent of patients. Despite our understanding of     the molecular basis of PC, current treatment is limited to mechanical removal of the thick     calluses, non-specific topical keratolytics, and oral retinoids, none of which alleviates     blistering or plantar pain satisfactorily. A public charity, PC Project, has been founded to     support the development of treatments for PC (www.pachyonychia.org). In collaboration with     this charity, a small company, TransDerm, Inc., has developed a small interfering RNA (siRNA)     that specifically targets a mutation in one of the PC keratins, K6a. As this siRNA targets a     single nucleotide mutation, it will only be effective against PC subjects harboring this     specific mutation. There are currently only six known patients who carry this mutation in the     International Pachyonychia Congenita Research Registry, but three of these patients live in     Salt Lake City (a mother and two of her children). We propose to perform a Phase Ib clinical     trial to test the safety and tolerability of TD101 in PC patients carrying an N171K mutation.     We will complete treatment of the adult patient prior to recruitment of the minors.   "
218874|NCT00716027|"     The purpose of this study is to determine whether a modified behavioral treatment for weight     loss that includes one-on-one treatment for individuals struggling to lose weight is     associated with more weight loss than a standard behavioral treatment.   "
218875|NCT00716040|"     All eligible patients will be invited to use electronic monitoring of medication (MEMS)     during the next six months. After two months with MEMS the enrolled patients will be     randomized to intervention group or to control group. The intervention group will be     submitted to four social-psycho sessions with a pre-trained health professional. The control     group will receive the usual care of the health service.      The study will compare the rate of adherence to antiretroviral therapy between the     intervention group and the control group. The duration of the study will be of six months.     The analysis will be based on intention-to-treat.   "
218877|NCT00716066|"     This phase II trial studies the side effects and how well carmustine, etoposide, cytarabine     and melphalan together with antithymocyte globulin before a peripheral blood stem cell     transplant works in treating patients with autoimmune neurologic disease that did not respond     to previous therapy. In autoimmune neurological diseases, the patient's own immune system     'attacks' the nervous system which might include the brain/spinal cord and/or the peripheral     nerves. Giving high-dose chemotherapy, including carmustine, etoposide, cytarabine,     melphalan, and antithymocyte globulin, before a peripheral blood stem cell transplant weakens     the immune system and may help stop the immune system from 'attacking' a patient's nervous     system. When the patient's own (autologous) stem cells are infused into the patient they help     the bone marrow make red blood cells, white blood cells, and platelets so the blood counts     can improve.   "
218878|NCT00716079|"     The purpose of this academic lead study is to determine if a treatment strategy of early     intensive blood pressure (BP) lowering compared to conservative BP lowering policy in     patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH)     improves the outcome of death and disability at 3 months after onset.   "
218879|NCT00716092|"     The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control     and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic     control.   "
218882|NCT00716131|"     Despite significant progress in the identification of mechanisms involved in motor neuron     degeneration in Amyotrophic Lateral Sclerosis (ALS) and other motor system diseases, the     actual pathogenesis and cause of these diseases remains unknown. Effective treatment of these     diseases are dependent on the elucidation of their causes. The availability of diseased and     control human tissues will be a critical resource for this research progress. . Samples of     serum, spinal fluid, and urine from patients with motor system diseases can be used to study     biochemical and genetic differences compared to tissues of neurologic disease controls and     normal controls. Furthermore, the availability of autopsied CNS, PNS, as well as other     tissues from patients with ALS or suspected ALS are useful for current and future research     studies into the disease. Therefore, we propose to institute a Tissue Bank containing blood,     urine, and cerebrospinal fluid donated from not only ALS and other motor neuron disease     patients, but also those with other neurologic diseases and normals whose tissue can be used     as controls. In addition there will be an autopsy band for post-mortem specimens of ALS and     other motor neuron disease patients. Each specimen, whether from a living patient or autopsy     will be de-identified and accompanied by a standard set of clinical information collected     from the medical records in order that each specimen is characterized with the relevant     clinical information to maximize the usefulness of the specimens.      Once established, this tissue bank will provide a resource in which a large number of samples     will be readily available and expedite research by circumventing the delays in collecting     specimens prospectively. These specimens will be used for research in the ALS Center of Hope     at Drexel University College of Medicine and shared with any outside investigator with a     valid IRB approved protocol.   "
218883|NCT00716144|"     Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or     placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and     efficacy of R115866 will be evaluated during the treatment period and the 8-week post     treatment follow-up period.   "
218884|NCT00716157|"     Questionnaire study to observe the incidence and pattern or nausea and vomiting in patients     receiving combined chemotherapy and radiation. 83% of patients experience radiation     therapy-induced vomiting; significant nausea and vomiting could develop with concurrent     chemotherapy despite standard anti-nauseous medication prophylaxis.   "
218885|NCT00716170|"     In order to investigate the mechanisms underlying the hyperglucagonemia characterizing     patients with type 2 diabetes mellitus (T2DM) we wish to test the following hypothesis: Do     pancreatic alpha-cells exhibit inappropriate glucagon responses to substances released from     the small intestine (GIP, GLP-2 and GLP-2) in patients with T2DM?   "
218886|NCT00716183|"     A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of     Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for     4 weeks. The three lactobacilli strains were originally isolated from milk of healthy women.     On days 0 and 28, milk samples will be collected, and staphylococci/streptococci and     lactobacilli will be counted and identified. Evolution of clinical signs will be recorded by     midwifes on days 0, 7, 14 and 28.   "
218887|NCT00716196|"     Objective: The purpose of this study was to compare the performance of the monolayer     preparation (Cyto Lyt or Thin prep) to the routine use of Papanicolau methods on the analysis     of specimens obtained using EUS-FNA.   "
218888|NCT00716209|"     The proposal seeks to establish:        -  A comprehensive compilation (database) of clinical information comprising clinical,          histopathological, treatment and follow-up characteristics of past and future          gastrointestinal cancer (GIC) cases in Singapore that can be shared by investigators.          The characteristics will include clinical (eg age, sex, stage), histopathological (eg.          grade, type), treatment (eg. treatment status, regimens) and outcome data (eg. survival,          toxicity) from medical records.        -  A collection (bank) of corresponding frozen and fixed tissue, blood and processed          samples (enriched blood mononuclear cells, protein, RNA, DNA, tissue arrays) in          Singapore that can be shared by the investigators.        -  A gastrointestinal cancer co-operative group (GCCG) of clinicians and scientists          researching prognostic and predictive markers in GIC, which will benefit from the          multi-disciplinary knowledge, information and samples of its members.        -  To characterise genetic polymorphisms related to Gastrointestinal cancer chemotherapy          treatment in controls (healthy volunteers)   "
218889|NCT00716222|"     There is a well-documented relationship between short sleep duration and high body mass index     (BMI). The mechanism linking short sleep duration and weight gain is unknown. Current studies     in healthy young volunteers have shown that experimental sleep restriction is associated with     dysregulation of the neuroendocrine control of appetite and with alterations in glucose     metabolism. The goal of our study is to determine the metabolic and hormonal modifications     induced by chronic sleep curtailment in obese adolescents and young adults and to observe if     short sleep is a negative prognostic factor in their weight evolution.   "
218890|NCT00716235|"     The purpose of this study is to characterize the profile of executive functions and eye     movements in several populations of children with developmental disabilities.   "
218891|NCT00716248|"     Patients with rheumatoid arthritis who have been well controlled with methotrexate plus     infliximab may remain in remission or low disease activity without infliximab. And the chance     of sustained remission increase by the addition of another DMARD, bucillamine, at the time of     discontinuing infliximab. The BuSHIDO trial is the prospective, randomized, controlled study     comparing MTX monotherapy and MTX plus bucillamine combination therapy as to the rate of     disease flare after discontinuing infliximab.   "
218893|NCT00716274|"     This study will evaluate the effects of atomoxetine on brain activation during attention and     reading tasks via functional Magnetic Resonance Imaging (fMRI) in patients ages 10 to 16     years old with ADHD and comorbid dyslexia   "
218894|NCT00716287|"     Anti-angiogenic targeted therapies are used in a wide range of solid tumors including NSCLC,     breast cancer, GISTs, CRC, renal cell carcinoma and hepatocellular carcinoma. Somatic     mutations in genes related to tumorigenesis have been associated with treatment response     whereas germline gene variants have been associated with tumor risk, prognosis and treatment     related toxicity.Study objectives are:        1. To characterise the prevalence and clinicopathological associations of germline and          somatic variation in genes involved in the angiogenic pathway in healthy donors and          unselected cancer patients        2. To examine the association between angiogenic gene variants and outcome in patients          receiving anti-angiogenic therapy   "
218895|NCT00716300|"     The aim of the study is to examine the kinetic, anti-oxidant, anti-inflammatory and cellular     cholesterol efflux properties of high-density lipoprotein (HDL) in subjects with the     metabolic syndrome (MetS) and lean individuals.   "
218896|NCT00716326|"     The aim of this study is to investigate the effectiveness of TENS in addition to routine care     in patients with chronic pain of predominantly neuropathic origin, compared to treatment with     routine care alone.      Hypothesis:      An eventually neuropathic pain component is needed to be identified and alleviated in chronic     pain patients to improve the quality of rehabilitation.      0-hypothesis:        -  TENS is not better than than placebo, medication or standard rehabilitation program.        -  A neuropathic pain component does not demand special considerations in rehabilitation of          chronic pain patients.   "
218897|NCT00716339|"     Purpose:      The aim of this study was to compare the effect of ciliary body training as proposed by     manufacturers of accommodating IOLs and patient motivation on the pseudoaccommodative ability     with a standard intraocular lens (SA60AT).      Setting:      Department of Ophthalmology, Medical University of Vienna.      Methods:      This randomized, controlled, examiner-masked study comprised 80 eyes of 40 patients that     underwent standard cataract surgery. Patients were randomly assigned to a motivated or     non-motivated (control) group. In the motivated group, subjects were told to take part in a     special protocol to improve their near-reading ability after cataract surgery and were     instructed not to use near adds for at least 3 months. Follow-up examinations included     best-corrected distance visual acuity (VA), distance-corrected near VA, best-corrected near     VA, defocus curve and reading speed, as well as pilocarpine-, cyclopentolate- and     nearpoint-induced IOL shift assessed with partial coherence interferometry.   "
218898|NCT00716352|"     This is a multi-centre UK study designed to evaluate if an educational intervention programme     delivered to health care professionals can improve the use of evidence based treatments in     the management of patients admitted to hospital with non-ST elevation Acute Coronary     Syndrome. A total of 38 centres participated, half received the educational intervention.     Patients were followed to hospital discharge. Patients were followed up at 6 months. Longer     term follow up through the Office Of National Statistics will be performed.   "
218899|NCT00716365|"     USF Hemostasis - USage of HemCon for Femoral Hemostasis after Percutaneous Procedures. A     Comparative Open Label Study The purpose of this trial is to test HemCon pad after diagnostic     percutaneous coronary angiography as an adjunct to manual compression to better control     vascular access site bleeding and reduce time-to-hemostasis.      We hypothesize that the use of HemCon bandage (containing a carbohydrate called chitosan,     found in the shells of shrimp, lobster and beetles) will shorten the time needed to achieve     hemostasis, time to patient's ambulation, and patient's satisfaction without increasing     vascular complications.      278 patients undergoing diagnostic coronary angiography receiving 2500 u intravenous Heparin     will be studied and randomized for manual homeostasis with either a HemCon or a regular pad.     Primary efficacy endpoint will be time to hemostasis. Secondary endpoints will be safety     (complication rate) and satisfaction of patients regarding time to sitting incline and time     to ambulation. 25% of patients from each arm will be randomized for Duplex examination of the     femoral artery at the access site.   "
218900|NCT00716378|"     This study, conducted at the University of Massachusetts at Amherst, will examine how male     teenage driving performance varies in the presence or absence of male teenage passengers. It     will explore what information teen drivers and their passengers use when making decisions     that affect their performance on the road.      Male drivers under 18 years of age who have a Junior Operator's or Full License and have     driven at least once in the month before enrolling in the study may be eligible to     participate.      In a university laboratory, participants sit in a 1995 Saturn sedan and operate the controls     of the car just as they would those of any other car, during simulated drives in urban,     suburban and rural areas. They are fitted with a head-mounted eye tracker that records their     point of gaze in real time. On one drive, the subject drives alone; on another, a male     passenger rides along. After the drives, the subject fills out some questionnaires.   "
218901|NCT00716391|"     An Open Label Randomized, Multi-Centre Phase III Trial of TPF Chemotherapy Plus Concomitant     Treatment With Cisplatin and Conventional Radiotherapy Versus TPF Chemotherapy Plus     Concomitant Cetuximab and Conventional Radiotherapy in Locally Advanced, Unresectable Head     and Neck Cancer.   "
218902|NCT00716404|"     This is a prospective, observational, multi-center study with consecutive enrollment. Up to     1,000 patients will be enrolled. The objective of this post-marketing surveillance study is     to collect clinical usage patterns of the Benephit Infusion Systems. As a result, FlowMedica     will be able to:        1. Better understand and quantify usage patterns including patient characteristics,          adjunctive procedures, and infusion agents.        2. Collect user-interface information and overall customer satisfaction.        3. Monitor post-marketing device performance.   "
218903|NCT00716417|"     Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone     chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU.      The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.   "
218904|NCT00716430|"     The main hypothesis to be tested is that the use of a quality improvement programme will lead     to measurable improvements in the management of care and use of evidence based treatments for     patients presenting to hospital with non-ST elevation acute coronary syndromes.   "
218906|NCT00716456|"     The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that     initially became smaller after taking erlotinib and then started to get bigger despite     continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug     administration for treatment of head and neck and colon cancer. The goal of the phase I     portion of this trial is to find out the highest dose of cetuximab that can be taken together     with erlotinib. This study will also give an idea of how well cetuximab shrinks lung cancer     when given with erlotinib.      The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that     initially became smaller after taking erlotinib or gefitinib and then started to get bigger     despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug     administration for treatment of head and neck and colon cancer. The goal of this phase is to     determine if cetuximab given with erlotinib causes lung cancers to shrink in size.   "
219395|NCT00723021|"     Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in     patients with asthma   "
218907|NCT00716469|"     Plexiform neurofibromas (PN) represent one of the most significant complications of NF1. They     are a significant cause of morbidity in neurofibromatosis type 1 (NF1) by causing pain,     impaired function, and disfigurement. They may become life-threatening through mechanical     compression of vital organs such as the trachea, great vessels, or spinal cord, and may     significantly interfere with normal function when located in the extremities or orbit. The     only effective therapy for PN is total surgical excision. However, due to local infiltration     of normal tissue, gross total resection is usually not feasible, and often PN are completely     unresectable due to their location, size, and multiplicity. To date, other therapeutic     modalities, including radiotherapy and chemotherapy, have not shown efficacy in PN.      In the present study, local photodynamic therapy will be investigated. Photodynamic therapy     (PDT) utilizes a drug, called a photosensitizer or photosensitizing agent, and a particular     type of light. When photosensitizers are exposed to a specific wavelength of light, they     produce a form of oxygen that kills nearby cells. PDT is expected to result in treatment     response with shrinkage of tumor. The main purpose of the study is to determine the maximum     amount of light that can be safely used with LS11 for PDT in children with plexiform     neurofibromas.   "
218908|NCT00716482|"     Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast     ultrasound examination provides useful information for the radiologist when imaging lesions     in the breast, as compared to conventional grayscale ultrasound alone.   "
218909|NCT00716495|"     In this open-label study of patients with advanced melanoma 20 evaluable patients will be     recruited.      The drug substance, AGI-101H, is a whole cell, allogeneic melanoma vaccine, representing a     mixture (1:1 ratio) of two therapeutic gene modified human melanoma cell lines, referred to     as Mich1H6 and Mich2H6, which has been gamma-irradiated to render the cells non-proliferative      Patients will receive treatment for up to 26 weeks. Progression at any time point requiring     systemic treatment with, for example with chemotherapy or cytokines will lead to withdrawal     of this patient from the study.      The dose chosen is 5 x 107 viable cells/dose.   "
218910|NCT00716508|"     We will compare two groups for acute patella tendon repair: one treated with surgical anchors     and the second, with transpatellar tunnels.   "
218911|NCT00716521|"     This study will assess the feasibility of conducting sleep studies in a clinical research     unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy     technologies will be compared for evaluating sleep stages and sleep architecture.   "
218912|NCT00716534|"     This study is designed to determine the clinical efficacy and toxicity of ABT-869 in     combination with carboplatin and paclitaxel in the treatment of subjects with advanced or     metastatic NSCLC.   "
218913|NCT00716547|"     The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg     and 100 mg ketoprofen in Diractin®.   "
218914|NCT00716560|"     The purpose of this study is to observe the incidence of nausea with systemic chemotherapy     that includes consecutive days (more than one day)of cisplatin medication.   "
218915|NCT00716573|"     After transplantation, renal impairment, incidence and progression of atherosclerosis lead to     modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI     and/or introduction of everolimus. The risk or benefits of these strategies were not clearly     evaluated by specific clinical trials.      This study is specifically designed for evaluating the impact of everolimus introduction,     with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and     clinical outcomes, specially on :        -  Renal function improvement        -  Vasculopathy and major cardiac event reduction        -  Maintenance of immunosuppressive efficacy   "
218916|NCT00716586|"     Seven patients with X-linked retinoschisis were treated with dorzolamide and the response to     this treatment was monitored using OCT. These patients were also tested for the causative     gene mutation and the resultant mechanism of functional loss of retinoschisin. It was     observed that a response to dorzolamide may be seen irrespective of the mechanism that leads     to decrease in function of retinoschisin.   "
218928|NCT00716742|"     To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal     clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each     follow-up visit (follow-up visits are variable as per physician discretion) and at final     follow-up visit.   "
218929|NCT00716755|"     Since side effects of antipsychotics, dopamine D2 receptor blockers, frequently occur in     older patients with schizophrenia and the risk is dose dependent, clinical guidelines     universally advocate the use of lower doses. However, there is no report to test this dosing     guideline with measurements of D2 receptor blockade caused by antipsychotics. In this study,     dopamine D2 receptor occupancy will be measured, using Positron Emission Tomography (PET), in     40 patients aged 50 and older with schizophrenia-spectrum disorders before and after a     gradual 40 % dose reduction of antipsychotics that was safely achieved in the past study     while setting a target dose still above the lower limit of the dose range recommended in     clinical guidelines for older patients. Our goal is to relate changes in clinical outcome,     including subjective and objective clinical ratings, to dopamine D2 receptor occupancy, and     compare these results with the data for younger patients in the literature.   "
223133|NCT00765674|"     This study evaluated the efficacy (blood pressure lowering effect) and safety of     aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.   "
218917|NCT00716599|"     Malaria remains one of the most devastating infectious diseases in the world. Despite the     potential for serious adverse outcomes with each episode of malaria, most cases in endemic     areas are diagnosed on clinical grounds alone. Even the simple technique of light microscopy,     the gold standard for malaria diagnosis, is inaccessible to most individuals in resource-poor     malarious areas. New diagnostic methods that are practical for limited health-care settings     are urgently needed. Immunochromatographic rapid diagnostic tests (RDTs) for malaria are easy     to use, require little infrastructure or expertise, show good accuracy, and are increasingly     advocated for routine use in malaria-endemic areas. A major challenge now is to implement     RDTs effectively in typical African clinical settings. We plan to evaluate the clinical     effectiveness and safety of a training curriculum incorporating RDT use in peripheral     government health centers in Uganda. Results from this study will provide evidence for     scale-up of RDT implementation in Uganda, as planned by the Uganda Ministry of Health from     mid-2008, as well as in other sub-Saharan African countries.      The aim of this study is to evaluate the clinical effectiveness and safety of a basic     training program incorporating RDTs, as compared with standard-of-care presumptive treatment,     for the management of patients who present with suspected malaria at peripheral health     centers in Uganda. Our hypothesis is that training in fever case management and RDT use will     allow health center staff to reduce unnecessary antimalarial prescriptions without     compromising patient outcomes, compared with the current practice of presumptive antimalarial     therapy for all febrile patients.   "
218918|NCT00716612|"     The purpose of this study is to determine whether Coenzyme Q 10 supplementation will decrease     the rate of Muscle Pain in patients with previous statin related Muscle Pain.   "
218919|NCT00716625|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
218931|NCT00716781|"     Intrapartum antibiotic prophylaxis has greatly decreased but not abolished early-onset     neonatal sepsis caused by GBS. According to current recommendations, the evaluation of     infants at risk for GBS sepsis should include a complete blood count (CBC), WBC differential,     a blood culture (BC) and a period of observation. The usefulness of CBC and BC in the     evaluation process is not firmly established.   "
218920|NCT00716638|"     This study will evaluate the effectiveness of trauma-focused cognitive behaviour therapy     (TF-CBT) versus eye movement desensitization and reprocessing (EMDR) in the treatment of     trauma survivors with post-traumatic stress disorder (PTSD). Patients will be randomly     assigned to TF-CBT or EMDR. Follow-up assessments will be conducted at 3 and 12 months     post-treatment. In addition to comparing the efficacy of the two protocols, an additional     focus will lie on identifying predictors for treatment outcome.   "
218921|NCT00716651|"     Churg-Strauss syndrome is a rare type of systemic vasculitis which occurs almost exclusively     in patients with asthma and which is characterized by prominent blood and tissue     eosinophilia. The disease has a chronic smoldering course with a permanent need for medium to     high corticosteroid doses. Available unselective immunosuppressive agents are often     insufficient to reduce corticosteroid doses, to induce complete remission and to protect     patients from disease flares which occur in more than 50 % of cases.      Interleukin-5 is the most potent cytokine regulating the production of eosinophil     granulocytes which are the major effector cells in Churg-Strauss syndrome. Recently, an     increased production of interleukin-5 was demonstrated in Churg-Strauss syndrome. Mepolizumab     is a monoclonal IgG antibody targeting interleukin-5 and is effective in the treatment of the     HES. The hypothesis of this study is, that mepolizumab will induce remission and allow for     steroid reduction.   "
218922|NCT00716664|"     The pilot study aims to evaluate the effects of a treatment series of gentle joint and muscle     movements (in addition to normal optimal care)on lung function, exercise capacity and posture     in stable adults with cystic fibrosis.   "
218923|NCT00716677|"     We plan to use the Life Shirt to record tidal volume, respiratory rate and breathing pattern     over a 6 hour period in patients admitted with difficult asthma. The Life Shirt will also be     used to collect the same data over the same time period in a group of healthy controls. This     data will then be correlated with the assessment of the supervising consultant as to whether     the patient has any element of dysfunctional breathing contributing to their symptoms. It is     hoped that the data obtained may in future be used to offer treatment to those patients with     dysfunctional breathing.   "
218924|NCT00716690|"     The proposed research focuses on the development of innovative protocol of mismatched stem     cell transplantation with combined 2 different haplo stem cell transplantation (SCT) donors     which are mismatched to the recipient (and preferably to each other), in a patient in need     for SCT, lacking an HLA match related or an unrelated donor. This innovative protocol named     multi donor stem cell transplantation (MDT) is designed to facilitate engraftment even when     reduced intensity conditioning or a low cell dose are used, improve the graft vs. leukemia     (GVL) effect and enhance immune reconstitution (using quantitative and qualitative     parameters).   "
218925|NCT00716703|"     Computed tomography (CT) scan using intravenous contrast (CT IV) as the sole type of contrast     material, was studied as one method of evaluating children with suspected appendicitis. We     felt that this technique could provide physicians with a faster and better-tolerated     alternative to CT imaging which involves patients drinking oral contrast or needing rectal     contrast administered.      SPECIFIC AIMS        1. To test an imaging protocol using CT IV for the evaluation of suspected appendicitis in          children in the setting of a pediatric emergency department (ED).        2. To determine test performance characteristics (specificity, sensitivity and diagnostic          accuracy) of CT IV in detecting appendicitis in children.   "
218926|NCT00716716|"     The primary objective of the study is to assess safety of FIXFc at doses ranging from 1 to     100 IU/kg.   "
218927|NCT00716729|"     The aim of this study is to develop an evaluative questionnaire, to evaluate patients with     hip and groin disability, and a strength measurement for the hip, for patients with hip and     groin disability.      Both measurement instrument are aimed for evaluating the natural course and different     treatment modalities in patients with hip and groin disability.   "
218977|NCT00717379|"     To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two     regimens of steroid in an adult kidney transplanted population.   "
218930|NCT00716768|"     Laparoscopic techniques have been applied widely to the management of various common     pediatric surgical diseases. Current evidence lacks sufficient quality to justify the     widespread adoption of the laparoscopic approach to the repair of inguinal hernias within     children. It is important to critically evaluate the efficiency and the potential risks of     these new techniques before they can supplant open techniques as the treatment modality of     choice. Numerous large case series of laparoscopic inguinal hernia repair have been reported     with average length of stay, complication rates, recurrence rates and pain management scores     that mirror those of open inguinal hernia repair. Only one randomized controlled trial has     been performed to compare the open versus laparoscopic technique which has not provided     answers regarding the potential benefits on young infants. Benefits of an open approach in     children includes a shorter operative time, while the laparoscopic procedure is associated     with less pain and a better cosmetic result.      This study will compare open versus laparoscopic repairs of inguinal hernias. The primary     outcome variable will be total dose of acetaminophen administered postoperatively for pain     management. Secondary outcome variables include 1) Incidence of intraoperative complications     such as compromise of testicular vessels, perforation of abdominal viscera; 2) Short-term     outcomes such as operative time, rate of conversion from open to laparoscopic procedure,     requirement for reoperation within 30 days, wound infection, acute hydroceles and     post-operative length of stay; 3) Long-term outcomes such as recurrent inguinal hernia,     testicular atrophy and; 4) Cost of hospitalization will be compared between the open and     laparoscopic groups.      Comparisons will be made in two groups of patients- patients with 1) unilateral hernias and     2) bilateral hernias and will last for 2 years. 102 patients in the unilateral arm and 50     patients in the bilateral arm will be randomized to each treatment group and each subject     will be followed for up to 12 months following the surgical intervention. Two study     evaluations by telephone (in addition to a single outpatient clinic visit already required as     part of standard post-operative care) will be required of each research subject and his/her     parent/guardian. The telephone evaluations will occur at 3 and 12 months following surgery.     The standard post-operative clinic visit is scheduled at 2 weeks following surgery.   "
219453|NCT00723814|"     To monitor the blood pressure level of the patient   "
218933|NCT00716807|"     Patients with chronic masticatory muscle pain (i.e., pain greater than three months) or     patients with burning mouth syndrome participate in this study. The aim of the study is to     compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered     with either placebo or naloxone, a drug used to treat opiate overdose. A second goal is to     determine if there are sex differences in these two drug regimens. Drugs will be administered     with single-use intranasal spray devices. All participants will receive two sprays (one spray     per nostril). One of the two sprays will be nalbuphine (5 mg). The other spray will be     naloxone in half the participants and placebo in the other half.   "
218934|NCT00716820|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
218935|NCT00716833|"     This randomised placebo controlled double-blinded bicentre study (phase III) was designed to     evaluate the preemptive and postoperative analgetic impact of etoricoxibe in open abdominal     and thoracic surgery. Etoricoxib selectively inhibits isoform 2 of cyclo-oxigenase enzyme     (COX-2).      Therefore 120 patients (ASA-risk 1-2) with upcoming abdominal or thoracic surgery should be     included into this study. Patients are randomly allocated to either the preemptive or the     postoperative Etoricoxibe group. These two groups are divided each into two arms. Preemptive     group patients get Etoricoxibe either twice (before and after surgery) or just a single     preoperative dose. Postoperative group patients get placebo before surgery and either a drug     application or a placebo again after surgery (so called 2x2 factorial study design).      Cumulative use of morphine as assessed within first 48 hours after surgery is the primary     trial outcome indicating the analgesic potency of Etoricoxibe.      In addition, changes in patients level of sensibilisation will be measured with help of     quantitative sensory testing (a standardised procedure) before and after surgery (secondary     outcome). In addition pharmacogenetic testing will provide information about genetic     aberrations (so called polymorphisms) of the patients enzymes that should be compared to the     individual reaction regarding Etoricoxibe.      The results will give hint about the analgesic impact of etoricoxibe in acute postoperative     pain. There will be findings for preemptive analgesia and nerval processes. All this could     lead to an improvement of postoperative pain relief while administrating preemptively a COX-2     selective inhibitor before surgery.   "
218936|NCT00716846|"     The purpose of this study is to investigate whether statins have any influence on cytochrome     P450 (CYP) 3A4 enzyme activity using a probe drug midazolam.   "
218937|NCT00716859|"     To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and     timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are     diagnosed with glaucoma.   "
218938|NCT00716872|"     The purpose of this study is to determine whether an Internet-based program, Sleep Healthy     Using the Internet (SHUTi, or Shut-Eye), can help to improve the sleep of people who are in     remission from cancer and experiencing symptoms of insomnia.   "
218939|NCT00716885|"     1. To assess whether a correlation exist between the degree of pulmonary clearance of free          radical positive white bloodcells and platelets and the degree of pulmonary congestion          in congestive heart failure (CHF) patients        2. To asses whether cardiac resynchronization therapy improves pulmonary clearance of free          radical positive white blood cells and platelets in CHF patients by alleviating          pulmonary congestion        3. Interaction of oxidative stress with circulating endothelial progenitor cells (EPCs) and          presence of apoptotic endothelial (progenitor) cells   "
218940|NCT00716898|"     The purpose of the study is to determine the Pharmacokinetics of Low Molecular Weight Heparin     (LMWH) in Cancer patients, and compare it to the Pharmacokinetics of LMWH in Patients without     cancer. We also intend to detect any correlation between heparanase blood and urine levels     and the Pharmacokinetics of LMWH.   "
218941|NCT00716911|"     RATIONALE: Tests that measure certain changes in blood in patients at high risk of     cytomegalovirus infection may help doctors learn more about predicting cytomegalovirus     infection after donor stem cell transplant.      PURPOSE: This clinical trial is studying tests that measure changes in the blood in patients     at high risk of cytomegalovirus infection after undergoing donor bone marrow transplant or     peripheral stem cell transplant.   "
218942|NCT00716924|"     Primary Objective: To test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24     hours prior to PCI produce a greater decrease of periprocedural release of biochemical     markers (CK, CK-MB, and troponin-T and/or I) of myocardial necrosis, compared to 300 mg     loading dose, given ≥ 6 and ≤ 24 hours prior to PCI or 600 mg loading dose of clopidogrel,     administered immediately (≤ 45 minutes) before PCI.   "
218943|NCT00716937|"     Recurrence, Complications, Work-off date, Healing time and Patients Willingness in Karydakis     Technique for Treatment of Sacrococcygeal Pilonidal Sinus versus Healing by Secondary     Intention (EHSI) Technique in Imam Khomeini Hospital from 2008 to 2011   "
218944|NCT00716950|"     Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events     of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but     often this result can be obtained with a combination therapy. Some evidences demonstrate     sartans and calcium channels blockers can be very useful and safe, but it is also important     to verify which association can give side effects or give some pharmacokinetic interactions     that can negatively influence the clinical combination efficacy.   "
218945|NCT00716963|"     The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded,     randomized, crossover study in which single doses of placebo, will be compared to Fluticasone     propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen     challenge, at cessation of the early allergic reaction (at 20% fall in FEV1 from     post-allergen peak)   "
218946|NCT00716976|"     RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving     cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than     no additional treatment in preventing hearing loss.      PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it     works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed     germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other     malignancy.   "
218947|NCT00716989|"     The goal of the vaccination is to induce humoral (antibody) and intracellular (T lymphocyte)     responses. Various data show that intradermal vaccination is more efficient than     intramuscular vaccination: the humoral response is statistically better after intradermic     vaccination, compared to intramuscular vaccination, even in target populations such as older     subjects or immunosuppressed patients   "
218948|NCT00717002|"     The overall objective of the study is to assess the feasibility of the use of blood for the     detection of EGFR mutations in patients with non-small cell lung cancer (NSCLC)      Specific aims are:        1. To assess the use of immuno-separation techniques to enrich the tumor cell population in          the blood of NSCLC patients.        2. To assess the use of denaturing high performance liquid chromatography (DHPLC) assay for          the detection of EGFR mutations in the blood of NSCLC patients.   "
218949|NCT00717015|"     We hypothesized that subjects with CYP2D6*10 alleles may have a lower steady state levels of     endoxifen due to reduced conversion of tamoxifen to endoxifen.      Primary objectives:        -  To determine the steady state pharmacokinetics of tamoxifen and its metabolites        -  To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of          tamoxifen and its metabolites in hormone receptor positive women who are taking          tamoxifen as adjuvant treatment for breast cancer.   "
218950|NCT00717028|"     The investigators objective is to describe functional endoscopic evaluation of swallowing     findings in children with cerebral palsy.   "
218951|NCT00717041|"     Many older adults have undetected health problems and lack basic prevention measures. Failure     to identify and treat these conditions can lead to unnecessary morbidity and mortality and a     decreased quality of life. Traditional screening and intervention programs, usually based in     primary care providers' offices, have been insufficient, particularly in medically     underserved populations. Alternate sites for screening and intervention have begun to receive     attention and may hold promise.      The emergency department (ED) is the entry point for access to medical and social services     for many patients and has the potential to serve as a site to identify older adults with     unmet needs. However, we do not know the prevalence of depression and cognitive impairment     and how they differ by mode of arrival of the patient to the ED. Second, a question remains     as to the validity of screening patients during an acute illness. Upon completion, this study     will describe the epidemiology of the population of older adults presenting to the ED.   "
218952|NCT00717054|"     The purpose of this study is to compare the incidence of nausea, vomiting, need for rescue     medication, prolonged PACU time, and unplanned hospital admission in patients with high risk     for post-operative nausea and vomiting (PONV) treated with oral aprepitant with or without     transdermal scopolamine preoperatively.   "
218953|NCT00717067|"     The purpose of this study is to assess whether a dosing adjustment is needed in patients with     renal impairment.   "
218954|NCT00717080|"     This is a Randomized Controlled Trial to study the role of Capsular Tension Ring in patients     with Retinitis Pigmentosa   "
218955|NCT00717093|"     The primary goal of this study is to compare efficacy of varenicline to placebo for cessation     of use of smokeless tobacco.   "
218956|NCT00717106|"     The purpose of this study is to obtain information on real-world device performance clinical     assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring     System.   "
218957|NCT00717119|"     Retrospective cohort study to evaluate the effect of the association of PPIs with NSAIDs in     work leave time.   "
218958|NCT00717132|"     To determine the cost effectiveness of treating the child alone and parent alone to     traditional family-based method of obesity treatment. It is hypothesized that a family-based     approach will be more cost effective, and will support the savings and effectiveness of     treating multiple family members together.   "
218959|NCT00717145|"     Randomized, open-label, multi-center, 4-treatment, 4-period crossover study. The study will     consist of a screening visit, study center admission (preceding Treatment Periods 1, 2, 3,     and 4), 4 treatment periods (4 days each), 3 washout periods (14 to 17 days in duration     separating each treatment period), and exit procedures.   "
218960|NCT00717158|"     The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of     life outcomes of a nutrition intervention involving lifestyle case management and medical     nutrition therapy by a registered dietitian compared to usual medical care in obese persons     with type 2 diabetes. The intervention is aimed at moderate weight loss (> 5-10%),     improvement in diet quality and an increase in physical activity.   "
218961|NCT00717171|"     The purpose of this study is to determine whether a functional electrical stimulation device,     the SurgiStim3, decreases pain, pain medications and/or edema in patients undergoing anterior     cruciate ligament repair.   "
219020|NCT00711165|"     A post-marketing study to look at the effects of Asmanex on markers of airway inflammation.   "
219021|NCT00711178|"     A randomised, multi-center study of daylight mediated photodynamic therapy (PDT) with Metvix     in patients with multiple actinic keratosis on the face and/or scalp.   "
218962|NCT00717184|"     1. To demonstrate the feasibility of leukapheresis and ex vivo activation of autologous NK          cells in patients with metastatic NPC        2. To demonstrate the safety of low dose systemic IL-2 in combination with escalating doses          of autologous Ex Vivo Activated NK cells in patients with metastatic NPC        3. To assess immune measurements such as quantitation of regulatory T cells, EBV specific T          cells, serum cytokine levels, and NK cell function after treatment with IL-2 and          autologous Ex Vivo Activated NK cells   "
218963|NCT00717197|"     The purpose of this study is to determine if capecitabine is effective in the treatment of     high grade gliomas that have returned after completing treatment.   "
218981|NCT00717431|"     The primary goal is to determine whether hippocampal electrical stimulation (HS) is safe and     more effective than simply implanting an electrode in the hippocampus without electrical     stimulation (HI), in patients with mesial temporal lobe epilepsy (MTLE). This will be     assessed by the rate of complex partial seizures per person-month over 6 months of follow-up     in HS vs. HI. There are two treatment arms: 1) Hippocampal Electrode Implantation with     Stimulation (HS). 2) Hippocampal Electrode Implantation without stimulation (HI). The     investigators expect to demonstrate that HS is safe and superior to HI in controlling     seizures in patients with MTLE.   "
218997|NCT00717639|"     This study aims at investigating the diagnostic accuracy of magnetic resonance angiography     using the contrast agent Vasovist® in the detection of relevant vascular narrowing of the     lower extremity. Patients who have been scheduled for intra-arterial conventional angiography     are eligible for this trial.   "
218964|NCT00717210|"     Background: The optimal treatment of anaplastic gliomas is controversial. Standard of care in     most centers is still radiotherapy. This phase III study compared the efficacy and safety of     radiotherapy vs chemotherapy in patients (pts) with newly-diagnosed, supratentorial gliomas     of WHO grade III.      Methods: Pts were randomized 2:1:1 between June 1999 and February 2005 in 34 German centers     to receive (i) a 6-week course of radiotherapy (1,8-2 Gy fractions, total dose 54-60 Gy) or     (ii) four 6-week cycles of CCNU at 110 mg mg/m2 on day 1, vincristine at 2 mg on days 8 and     29 and procarbazine at 60 mg/m2 on days 8-21 or eight 4-week cycles of 200 mg/m2 temozolomide     on days 1-5. Treatment was stopped prematurely at disease progression or occurrence of     unacceptable toxicity. At this time or at disease progression, treatment in the radiotherapy     group was continued with one of the chemotherapies (1:1 randomization) and with radiotherapy     in both chemotherapy groups. The primary endpoint was time-to-treatment-failure (TTF) defined     as progression after radiotherapy and one chemotherapy in either sequence, or any time before     if further therapy could not be employed. Assuming a 50% improvement in TTF of starting with     chemotherapy, 318 pts were to be enrolled to provide 80% power to achieve statistical     significance at a one-sided level of 0.05.   "
218965|NCT00717223|"     The purpose of this study is to see if a patient's ability (and/ or parent) to read, write,     and do basic math problems affects blood sugar control in children with type 1 diabetes     mellitus.   "
218966|NCT00717236|"     This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab     pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.   "
218967|NCT00717249|"     This study compares the performance of an investigational contact lens to a currently     marketed lens.   "
218968|NCT00717262|"     The purpose of this study is to evaluate the safety, activity and pharmacokinetics of a new     investigational drug (HQK-1001) in healthy human volunteers. This study will also evaluate if     there are differences in these parameters when HQK-1001 is administered in a fed versus a     fasted state.   "
218969|NCT00717275|"     The purpose of this study is to determine if administering temozolomide after completion of     stereotactic radiosurgery helps control existing brain metastases and prevents the     developement of new brain metastases.   "
218970|NCT00717288|"     In this study we will determine the proper method for transitioning patients from a     continuous insulin infusion to periodic injections of a newer long-acting insulin called     detemir (Levemir).   "
218971|NCT00717301|"     The purpose of the study is to determine if a specific blood protein, S-100B, can help     predict who will have a traumatic abnormality on head CT scan after a concussion. We will     compare the levels of this protein in the subject's blood to the initial head CT scan and to     how the subject is feeling one month after injury. We hope that the information we collect in     this trial will help us determine who needs a head CT scan after a concussion and who may be     more likely to have trouble recovering from a concussion.   "
218972|NCT00717314|"     This 2 arm study will compare the efficacy and safety of switching to CellCept combined with     different regimens of reduced calcineurin inhibitors (CNI) in patients with liver     transplants. Patients currently receiving CNI treatment will be randomized into one of 2     groups to receive either 1) CellCept 2.0g/day po bid + 50% reduction of CNI from baseline or     2) CellCept 2.0g/day po bid + >=75% reduction of CNI from baseline. The anticipated time on     study treatment is 1 year, and the target sample size is <100 individuals.   "
218973|NCT00717327|"     Do adolescents know about their medications?   "
218974|NCT00717340|"     This is a standard Phase 1b and 2a, multi-center, study design that will examine the safety,     tolerability, maximum tolerated dose, and overall response rate of tivozanib (AV-951) and     paclitaxel in a breast cancer.   "
218975|NCT00717353|"     Primary        1. To determine the presence and frequency of novel and known UGT1A6 and UGT2B7          polymorphisms in healthy Chinese, Malay and Indian subjects.        2. To determine the presence and frequency of novel and known UGT1A6 and UGT2B7          polymorphisms in Chinese lung cancer patients with squamous cell and adenocarcinoma          subtype.        3. To analyze the functional variations in UGT1A6 and UGT2B7 polymorphisms.      Secondary      1 To study the correlation of UGT1A6 and UGT2B7 polymorphisms with lung cancer type.   "
218976|NCT00717366|"     This sequential study will assess the efficacy and safety of multiple doses of intravenous     Mircera, and will determine the optimum starting dose for maintenance treatment of anemia in     children with chronic kidney disease on hemodialysis. Pediatric patients will remain on     epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they     will receive intravenous Mircera monthly, at a starting dose related to the previous weekly     epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be     selected to receive a higher or a lower dose. The anticipated time on study treatment is 3-12     months, and the target sample size is <100 individuals.   "
218978|NCT00717392|"     Hippotherapy is every program of horseback riding meant to treat people with physiological,     mental, social, cognitive or behavioral problems. The purpose of the current research is to     evaluate the efficacy of hippotherapy for children with developmental disabilities. The     hypothesis is that children with developmental disabilities who are treated with hippotherapy     will show better outcomes than children with the same problems who are not treated with     hippotherapy.   "
218979|NCT00717405|"     This single arm study will assess the efficacy and safety of preoperative treatment with     Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory     HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of     pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is     3-12 months, and the target sample size is <100 individuals.   "
218980|NCT00717418|"     This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other     non-prescription treatments in patients with dry eye disease. Patient and physician     assessments completed at baseline, at each follow-up visit (follow-up visits are variable as     per physician discretion) and at final follow-up visit.   "
218998|NCT00717652|"     The objective of this study is evaluating the clinical activity of the association (tretinoin     + arbutin + triamcinolone) in the treatment of epidermal melasma.   "
218982|NCT00717444|"     In this Stage 1 therapy development project, we plan to develop, formalize, and derive effect     size estimates of a contingency management (CM) therapy that focuses on improving health,     especially as related to increasing low intensity physical activities, such as walking,     resistance training, and stretching. The Healthy Activities for Prize Incentives (HAPI)     intervention will be targeted toward and tested within HIV-positive substance abusers who     attend HIV drop-in centers. After initial therapy development in a Stage 1a pilot project     with 9 patients, the therapy manuals and materials will be adapted and refined. In a Stage 1b     controlled trial, we will recruit and randomize 70 substance abusing HIV-positive patients to     (a) HAPI plus 12-step facilitation therapy or (b) contingency management for abstinence plus     12-step facilitation therapy. Each intervention will consist of one weekly individual therapy     session for 16 weeks. All participants will provide urine and breath specimens twice weekly     that will be tested for opioids, cocaine, methamphetamine, marijuana and alcohol. Patients in     both conditions will earn the chance to win prizes for submitting drug-negative specimens,     and those randomized to the HAPI condition will also earn the chance to win prizes for     engaging in healthy activities. Physical activity levels, drug use, psychological symptoms,     and subjective and objective indicators of health (body mass index, waist circumference,     blood pressure, viral load) will be measured pre-treatment and at months 2 and 4     (post-treatment), as well as at a 7-month (3 months after treatment) follow-up evaluation.     Compared to those receiving 12-step facilitation with contingency management for abstinence,     we expect that those in the HAPI condition will participate in more physical activities,     decrease drug use to a greater extent, evidence reduced depression, and show trends toward     improvements in health indices. If effect sizes in at least the small to medium range are     noted across all domains, we will consider the therapy appropriate for further evaluation in     a Stage 2 therapy development study.   "
218983|NCT00717457|"     This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared     with exenatide in patients with type 2 diabetes mellitus inadequately controlled with     metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive     taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly)     or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in     a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either     alone or in combination. The anticipated time on study treatment is 3+ years, and the target     sample size is >500 individuals.   "
218984|NCT00717470|"     To compare how well the new formulation of Tacrolimus® used once daily, in combination with     other drugs helps prevent the rejection of a new kidney after transplantation compared to the     twice daily dose of Tacrolimus   "
218985|NCT00717483|"     The landmark study Diabetes Control and Complication Trial (DCCT) clearly showed that     intensive insulin management delays the onset and progression of longterm complications in     adolescents with type 1 diabetes mellitus (T1DM). The same clinic trial also showed increased     rate of severe hypoglycemia which required assistance. The risks of severe hypoglycemia,     defined as loss of consciousness or seizure associated with hypoglycemia, include lower     HbA1C, younger age, higher insulin dose, male sex, lower parental socioeconomic status,     non-Hispanic white ethnicity, longer duration of disease, the presence of psychiatric     disorders, and underinsurance.      The purpose of this protocol is to explore the relationship between hypoglycemic seizures and     BMI.   "
218986|NCT00717496|"     This randomized controlled trial will evaluate an innovative telephone-based breastfeeding     education and promotion intervention that will be implemented in a low-income, predominately     Latina population. The trial will assess the impact of the intervention on duration of     breastfeeding and exclusivity of breastfeeding at 1, 2, 3 and 6 months post-partum.   "
218987|NCT00717509|"     We are going to investigate the association of multiple genetic polymorphisms with the     metabolic side effects in patients with schizophrenia taking clozapine.   "
218988|NCT00717522|"     The purpose of the study is to determine the safety and efficacy of single agent CC-4047     (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are     refractory to prior anticancer therapy.   "
218989|NCT00717535|"     RATIONALE: Studying umbilical cord blood in the laboratory and gathering information about     current and previous pregnancies from African-American umbilical cord blood donors may help     doctors learn more about the umbilical cord blood of these donors.      PURPOSE: This clinical trial is looking at umbilical cord blood from African-American donors.   "
218990|NCT00717548|"     The purpose of this study is to perform an evaluation of a trauma-focused short-term     intervention (Narrative Exposure Therapy; Schauer, M., Neuner, F. & Elbert, T.) on a variety     of clinical outcome measures (PTSD, Depression, Somatic Complaints, Dissociation) in women     after sexual exploitation and women trafficking.   "
218991|NCT00717561|"     The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is     as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by     oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired     pneumonia.   "
218992|NCT00717574|"     The study hypothesizes that adding 60% nitrous oxide to a steady state sevoflurance or     propofol anesthetic will lead to a decrease in both BIS and Entropy indices during a constant     level of surgical stimulus   "
219022|NCT00711191|"     This study aims to seek evidence that activation of certain cells of the immune system will     be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence     of clinical anti-tumor activity will be sought.   "
224007|NCT00784446|"     Assessment of safety and toxicity, definition of the dose limiting toxicity (DLT) of the     combination therapy consisting of Capecitabine, Oxaliplatin, Bevacizumab and Imatinib.   "
218993|NCT00717587|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed. Giving it after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well sunitinib works when given before and after     surgery in treating patients with stage IV kidney cancer.   "
218994|NCT00717600|"     Many children who catheterize their bladders because of spina bifida or other neurologic     disorders have bacteriuria. This can lead to urinary tract infections by bacteria from the     gut which colonize the vagina and are carried into the bladder during catheter passage. We     seek to test whether oral administration of probiotic bacteria can displace these     vagina-derived uropathogens and reduce or prevent bacteriuria in girls with spina bifida who     empty their bladders through catheterization.   "
218995|NCT00717613|"     This study includes an interview with men who have selected watchful waiting or active     surveillance for their localized prostate cancer, in lieu of active treatment (such as     surgery or radiation). We hope to understand the educational and support needs of men on     surveillance so that we can develop a new intervention that will improve quality of life for     such men.   "
218996|NCT00717626|"     The primary objective of this study is to test the feasibility of a large-scale clinical     trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy     outcomes so that we can better plan a large-scale study; we will estimate the effect size and     variability of effect and resource utilization of once-daily prophylaxis to allow us to set a     sample size for a definitive trial.   "
218999|NCT00717665|"     This study is an open randomized controlled trial of 12-month duration, which compares the     use of a home blood pressure (BP) tele-management system to the usual approach of home BP     monitoring in older diabetic patients with uncontrolled systolic hypertension. The purpose of     this study is to determine whether home blood pressure tele-management system will markedly     improve blood pressure control in a primary care setting.   "
219000|NCT00717678|"     The purpose of this study is to compare the efficacy and safety of Prograf extended     release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.   "
219001|NCT00717691|"     The purpose of this study is to regain range of motion of the great toe with dynamic     splinting which will help reduce great toe's pain and swelling.   "
219002|NCT00717704|"     Patients are being asked to take part in this study because they have been diagnosed with an     advanced solid tumor that is not responding to standard treatments. This study will find the     highest dose of ixabepilone and dasatinib in combination that can be given without causing     severe side effects.      Both ixabepilone and dasatinib have individually been tested in many (several thousand)     patients, however the combination of the two drugs has not yet been tested in humans.      All patients who will take part in this study will receive combined drug therapy of dasatinib     and ixabepilone. Dasatinib is a pill that is taken by mouth. Ixabepilone is a medicine that     will be given by vein (IV).      All participants will receive ixabepilone by vein once every three weeks as well as dasatinib     by mouth once daily.   "
219003|NCT00717717|"     The PACT Study (Physical Activity after Cancer Treatment) is a unique study within the field     of cancer rehabilitation in Denmark. It differs from other studies mainly due to the     intervention itself. A combination of physiological, health educational and therapeutic     elements will be tested. These components are incorporated into a one-year training program     for mixed groups (i.e. men + women, with varying cancer diagnoses) to encourage them to     enhance their well.-being and quality of life. The overall aim of this approach is to place     increased focus on the treated cancer patient's introduction to and exploitation of both     physiological and psychosocial yields through physical exercise. Whether or not the study     results bear a positive effect, they are expected to support new knowledge in rehabilitation     for cancer survivors.   "
219004|NCT00717730|"     Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or     without simultaneous administration of vitamin B12 reduces the rates of acute lower     respiratory tract infections (ALRI), clinical pneumonia and diarrhea.      Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of     folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a     low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months     will be identified through a survey. Eligible and willing Children aged 6-30 months will be     randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by     the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child     weight and length taken. The baseline blood samples will be collected. The supplements will     be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by     field workers.   "
219005|NCT00717743|"     To define the frequency of T regulatory cells in peripheral blood of RCC patients before and     after nephrectomy.      Study hypothesis: That nephrectomy results in a normalisation of peripheral blood T regs in     early stage RCC, and a lowering of T regs in advanced RCC.   "
219006|NCT00717756|"     This study will determine whether lenalidomide has activity in patients with advanced liver     cancer that have had growth of their cancer after sorafenib.   "
219007|NCT00705601|"     To begin to refine development of the RSQ (Restorative Sleep Questionnaire) measure in     subjects with NRS (Nonrestorative Sleep) by generating item content pertaining to morning     refreshment and uncovering problems in instrument administration in subjects with     nonrestorative sleep   "
219008|NCT00705614|"     Prospective, observational, parallel-group, postmarketing safety surveillance registry in     participants treated with Remicade or standard therapy for active or fistulizing Crohn's     disease (CD). The follow-up period is up to 5 years. The participants in the standard therapy     group may switch over to Remicade any time during the follow-up period   "
219037|NCT00711399|"     The study goal is to create a database of respiratory sounds recordings, to evaluate and     validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing     the severity of the respiratory symptoms before and after the administration of the     treatment.   "
219094|NCT00717990|"     This study will evaluate the efficacy of Irinotecan,Capecitabine and Avastin combination in     patients with no response to previous treatment with 5-Fluorouracil,Leucovorin,Eloxatin and     Avastin.   "
219009|NCT00705627|"     Locoregionally advanced nasopharyngeal carcinoma (NPC)(stage III, IV in UICC 2002     Classification) can be divided into two groups according to the risk of metastasis: high-risk     metastasis group (T4 or N2-3) and low-risk metastasis group (T3N0-1). In low-risk metastasis     group, concurrent chemoradiotherapy (CCRT) might decrease local recurrence and distance     metastasis, which benefits overall survival. On the other hand, neoadjuvant chemotherapy is     also associated with lower distance metastasis of advanced stage NPC. Nevertheless, CCRT     alone or neoadjuvant chemotherapy alone leads to unsatisfactory results regarding to distance     metastasis in patients with high-risk metastasis group. In this case, it is utmost important     to investigate the new treatment combining neoadjuvant chemotherapy plus CCRT in order to     improve overall survival of locoregionally advanced NPC with high-risk metastasis.      In our study, in order to investigate the effect and adverse reaction of neoadjuvant     chemotherapy plus CCRT on distance metastasis and locoregionally relapse, four hundred     patients with high risk of distance metastasis will be randomly divided into two groups,     comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to     find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of     distance metastasis.   "
219010|NCT00705640|"     RATIONALE: Vaccine therapy may help the body build an effective immune response to kill tumor     cells.      PURPOSE: This randomized clinical trial is studying how well vaccine therapy works in     treating patients with advanced melanoma.   "
219011|NCT00705653|"     This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and     to establish what happens to the drug once inside the body. An escalating dose of PG-11047     will be investigated in this study and the maximum tolerated dose of the drug will be     established.   "
219012|NCT00705666|"     In February 2002, a French Consensus Conference on the management of patients with chronic     hepatitis C in France was organized. The jury issued several recommendations on pegylated     alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is     of interest to understand the evolution of hepatitis C management in France in real clinical     practice. This observational study will permit the identification of patients who are treated     and will provide information on the use of PegIntron/ Ribavirin.   "
219014|NCT00711087|"     The purpose of this study is to see what the effect of Botox has on bladder function for     those who have recently suffered spinal cord injury. We also will study bladder tissue levels     of NGF (nerve growth factor) that can tell us how the nerves to the bladder are healing after     injury.      Consenting male and female cervical and high thoracic (T10 and above) SCI patients will be     identified within the first 6-7 weeks after SCI and randomized to two external urethral     sphincter injection groups. Each group will be injected within 8 weeks after SCI (Day 0) and     3 months later (Day 90). The injection paradigm will consist of: Group 1-100 units of BTX-A     (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90; Group 2-sham     saline injections on both Day 0 and Day 90. Injections will be performed under local     anesthesia using standard flexible cystoscopic equipment.      Use of placebo is justified because: 1. there have been documentation of nerve     desensitization with dry needling (i.e. acupuncture) and wet needling (i.e.     saline)--therefore, to truly demonstrate benefit of Botox over just the needle insertion into     the sphincter muscle or injection of the diluent saline, a sham saline injection group is     included, 2. the injection procedure itself is minimally invasive and not expected to result     in any complications.      Subjects who qualify and have signed the informed consent document will be randomized into     two groups, those receiving the BTX-A and those receiving placebo. Blinding will be performed     by the TIRR pharmacy department who will provide Botox and placebo in identical syringes so     that the treating staff will be blinded. Pharmacists will ensure patients receive the same     agent at the time of the second injection. Unblinding will occur at the end of the study or     if complications necessitate breaking of the code. Both groups will undergo urodynamic     testing to document before and after treatment data. Bladder biopsies will be taken prior to     treatment in both groups that will be analyzed for nerve growth factor. Three day voiding     diaries will be kept and reviewed with the study coordinator at the follow up visits. Quality     of life questionnaires will be completed at each follow up visit. The treatments will take     place on Day 0 and Day 90. Follow up visits will occur at Day 120, 16 month, and 28 months.   "
219015|NCT00711100|"     Recently, tobacco companies have developed new oral tobacco products that are purportedly     less harmful than conventional tobacco products. These products have not been tested by     independent research for their health effects or consumer palatability. In addition, it is     not known if these products will be used in addition to cigarette smoking or as a substitute     to cigarettes. These two studies will examine four oral tobacco products to answer some of     these questions.      The goals of this first study will be to examine: 1) the brand of oral tobacco products which     is preferred by cigarette smokers and the pattern and amount of product use when used as a     switching tool; 2) the characteristics that are associated with product choice; 3) nicotine     exposure from these products; and 4) the withdrawal symptoms from the tobacco products and     potential for continued use.      Specifically, our primary aims hypotheses were: 1) the product that will be chosen by most     smokers will be based on taste and sensory aspects of the product with products higher in     nicotine content more likely to be chosen as the preferred product; and 2) subjects will     experience no difficulty using the product for complete cigarette substitution, but a small     minority will engage in dual product use.      For the secondary aims, we hypothesized: 1) that compared to the subjects' own brand of     cigarettes, the biomarkers for exposure for the oral tobacco products will be significantly     lower; 2) withdrawal symptoms from the oral products are likely to occur, but are likely to     be mild compared to cigarette withdrawal.   "
219016|NCT00711113|"     The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture     Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading     protocol. Primary objectives are implant stability, marginal bone adaptation and survival     rate.   "
219017|NCT00711126|"     This study will involve the use of a new medicine called GW642444 being developed for the     treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the     study is to see how safe and how well tolerated the study drug is when it is given as a     liquid by mouth or by injection into a vein. In addition the study will measure how much of     the medicine gets into the bloodstream when it is given by mouth, by injection into a vein     and inhaled, and how long the body takes to get rid of it.   "
219018|NCT00711139|"     The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE     AD01 applied during AFFiRiS 001   "
219019|NCT00711152|"     1. To recruit 600 type 2 diabetic patients managed in a community setting.        2. To enrol into the Joint Asia Diabetes Evaluation (JADE) Program.        3. All patients will undergo annual comprehensive assessment (CA) at a diabetes centre with          personalized JADE report (JADE) at basline. Half of the randomized patients will be          managed with additional support by a trained community health worker (CHW) (JADE+CHW).        4. All patients will undergo annual comprehensive assessments for comparison of attainment          of treatment targets for 3 years   "
219023|NCT00711204|"     A 12-week, multicenter, randomized, double-blind, placebo-controlled phase IV study.     Approximately 200 subjects will be enrolled, half will receive active drug (donepezil     hydrochloride) and half will receive matching placebo at approximately 50 research sites     within the US, the European Union, South Africa and Australia. Eligible subjects will reside     at home, in an assisted living facility, or nursing homes age and will be 50 years or older,     with a diagnosis of Alzheimer's disease in the severe stage. All subjects must start with 5mg     a day (one 5 mg tablet of donepezil HCL or matching placebo). Dose will be increased to 10 mg     a day (two tablets of 5 mg donepezil HCL or matching placebo) after 4 weeks. Dose may be     decreased based on side effects. The primary efficacy measure will be the Cornell Scale for     Depression in Dementia (CSDD). Secondary measures will include Functional Assessment Staging     (FAST), Mini-Mental State Examination (MMSE), NPI-10 (Neuropsychiatric Inventory), DEMQOL     Proxy ( Quality of Life). Blood levels of cytokines and safety will also be assessed.   "
219024|NCT00711217|"     The study objective is to compare outcomes in subjects with a diabetic foot ulcer after 16     weeks of consuming a medical food versus a calorically similar control drink.   "
219051|NCT00711581|"     The purpose of this study is to determine the safety and efficacy of the Endograb system     which is an internal laparoscopic retractor device. This retractor device is inserted into     the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate     dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal     incisions in a laparoscopic operation.   "
219455|NCT00723840|"     This observational study will evaluate the social cost and quality of life of participants     who have had Crohn's Disease for at least 6 months and have active disease despite drug     therapy. Participants are followed for a total of 18 months.   "
219025|NCT00711230|"     DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a     single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These     particles are safe; replication, integration and reverse transcription deficient. DermaVir is     targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with     DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected     cells.      GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded,     multicenter study to assess the safety, tolerability, immunogenicity, and preliminary     antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with     HIV-infection.   "
219026|NCT00711243|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, oxaliplatin, and fluorouracil, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when     given with oxaliplatin and fluorouracil and to see how well they work in treating patients     with metastatic or unresectable stomach cancer, gastroesophageal junction cancer, or other     solid tumor.   "
219027|NCT00711256|"     The investigators want to investigate whether sunscreen is removed by clothing and to what     extend when the amount of sunscreen applied varies.Does clothing reduce the SPF when clothes     are put on 20, 8, or 4 minutes after sunscreen application? The investigators also want to     investigate the persistence of sunscreen during eight hours indoor. How much does the SPF     reduces? Furthermore, we want to investigate whether sunscreen in the layers 2, 1, and 0.5     mg/cm2 reduce the vitamin D production in the skin.   "
219028|NCT00711269|"     The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients     with schizophrenia.   "
219029|NCT00711282|"     The purpose of this study is to evaluate the clinical performance of implants placed in     individuals who are about to loose one or more of their upper teeth. The main objective is to     study how the surrounding bone tissue reacts to two different shapes of implants. Clinical     performance, in wider terms, means esthetics and long lasting function. Half of the patients     will receive a cylindrically shaped implant and the other half will receive a     conical-cylindrical implant. The implants will be placed and after a healing period of 16     weeks the gum will be re-opened and the bone tissue response clinically evaluated. Permanent     artificial tooth/teeth will be attached six weeks after that.   "
219030|NCT00711295|"     The purpose of this study is to assess the safety and tolerability of, and the immune     response to a non-adjuvanted H5N1 influenza vaccine in an adult and elderly population and in     specified risk groups. Furthermore, persistence of H5N1 influenza antibodies after     vaccination with this vaccine will be assessed.   "
219031|NCT00711308|"     The purpose of this study is to evaluate the feasibility of the long-term treatment of     pulmonary embolism with tinzaparin compared to oral anticoagulants.   "
219032|NCT00711321|"     The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE     AD02 applied during AFFiRiS 002   "
219033|NCT00711347|"     An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract     surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy     Iris Syndrome exists.   "
219034|NCT00711360|"     The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of     measuring the intrathoracic impedance on a daily basis and transmission of impedance trend     data via the Home Monitoring technology. In future, this will allow for automatic early     detection of imminent decompensation at a presymptomatic stage and immediate initialization     of clinical meaningful therapeutic interventions preventing heart failure related     hospitalizations. The aim of this investigation is to record long-term impedance trends in     heart failure patients with and without heart failure related events (hospitalizations due to     acute decompensation) in order to develop algorithms for device-based early detection and     warning of HF deterioration accompanied by pulmonary congestion.   "
219035|NCT00711373|"     This is a clinical trial of unilateral and bilateral hand transplantation. This will be done     by the surgical transfer of a hand from a non-living donor to restore function of     non-functioning or amputated hand. Recipients must currently take the same type of drugs as a     kidney transplant patient to prevent rejection of the hand.   "
219036|NCT00711386|"     To determine safety, tolerability and Pharmacokinetics of GSK706769   "
224027|NCT00784732|"     This study will compare the effectiveness of QAV680 against placebo in treating the symptoms     of seasonal allergic rhinitis in an Environmental Exposure Chamber.   "
219038|NCT00711412|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin     together with radiation therapy works in treating patients with esophageal or     gastroesophageal junction cancer.   "
219039|NCT00711425|"     The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture     Osseospeed™, in patients with tooth loss in the posterior mandible in an early loading     protocol. Primary objectives are implant stability, marginal bone adaptation and survival     rate.   "
219040|NCT00711438|"     The aim of this study is to test the feasibility of conducting a pragmatic fast track     Randomized Controlled Trial (RCT) of the Breathlessness Intervention Service (BIS) versus     standard care for patients with COPD and their carers, and to begin testing the effectiveness     of the intervention.   "
219041|NCT00711451|"     The purpose of this study is to evaluate whether manual removal of the placenta during a     cesarean delivery results in higher changes in the resistance of blood flow throughout the     body, also called systemic vascular resistance (SVR)   "
219116|NCT00718523|"     This study will determine the value of adding AMG 479 (fully human monoclonal antibody     against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with     optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian     epithelial (including fallopian tube and primary peritoneal) carcinoma.   "
219042|NCT00711464|"     Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This     includes many types of cognitive dysfunction, such as in attention, memory and language.     These problems may explain why patients with schizophrenia think and act in unusual ways, and     often have problems managing aspects of their lives that healthy adults take for granted.     Unfortunately, the biochemical aspects of these dysfunctions are presently unknown, and it is     not clear whether current psychiatric medications can improve these functions. A recent     FDA-approved medication that may improve this function is modafinil. Studies in animals and     healthy adults show that this medication can improve many of these cognitive functions. We     plan to study the effects of modafinil on these cognitive processes, by giving various doses     of this medication to patients before they perform tasks of these cognitive processes. We     will also enroll healthy adults in these same procedures in order to determine how these     effects are manifest in normal-range cognitive function. We predict that when patients or     control participants receive modafinil, they will perform better on cognitive tests, and that     these benefits will depend on the dose given.   "
219043|NCT00711477|"     The purpose of this study was to assess the effect of naltrexone SR/bupropion SR (NB) on     brain function in response to food cues using functional magnetic resonance imaging in     overweight or obese subjects.   "
219044|NCT00711490|"     Objective: Diabetic macular edema (DME) is a frequent manifestation of diabetic retinopathy,     a leading cause of blindness in the United States. The only proven treatment for DME is laser     photocoagulation. Sirolimus has been shown to inhibit the production, signaling and activity     of many growth factors relevant to the development of diabetic retinopathy. Therefore, this     study will investigate the safety and efficacy of multiple sirolimus injections in patients     with DME.      Study Population: Eligibility criteria include central macular thickening > 260 microns and     visual acuity 20/32 or worse in one or both eyes.      Design: Five participants will be enrolled into this open-label pilot study. After receiving     a 20 μL (440 μg) subconjunctival injection in the study eye at baseline and Month 2, the     participants will be re-evaluated every two months for at least one year for possible     additional injections. During follow-up, participants will not undergo re-injection if they     show significant clinical improvement or treatment success, defined as no intraretinal fluid     or cysts present on optical coherence tomography (OCT) OR 100% reduction in excess retinal     thickness over 260 microns on OCT OR no leakage on fluorescein angiography (FA). Beginning at     Month 4, participants will be assessed for treatment failure, defined as loss of 15 or more     letters of vision compared to baseline at two consecutive visits OR a 50% or greater increase     in total retinal thickness as measured by OCT at two consecutive visits. Individual     participants deemed treatment failures will continue receiving sirolimus injections, but will     be allowed to receive focal laser therapy for any amenable leaking microaneurysms at Month 4.     Beginning at Month 6, focal laser therapy will be permitted for both treatment failures and     participants who do not meet the criteria of a treatment success. Participants will have the     option of continuing treatment until a common termination date of one year.      Outcome Measures: The primary outcome is the change in visual acuity in the study eye at six     months compared to baseline. Secondary outcomes include changes in visual acuity in the study     eye at one year as compared with baseline, changes in retinal thickness as measured by OCT     and changes in fluid leakage in the macula as demonstrated by FA at six months, one year and     throughout the study period in the study and fellow eyes. Safety outcomes include number and     severity of systemic and ocular toxicities, adverse events and infections, and the number of     participants withdrawn from study therapy.   "
219045|NCT00711503|"     A draw trial of the effect of Interleukin-1 Receptor Antagonist (anakinra, Kineret®) on the     insulin production in patients with new onset Type 1 diabetes.      Kineret® is already being used in the treatment of patients suffering from rheumatoid     arthritis and preclinical studies are now suggesting that it may also be useful for patients     with Type 1 diabetes. The active substance in Kineret is interleukin-1 receptor antagonist, a     blocker of an immune-signal molecule named interleukin-1.      The trial is a blinded randomised trial, in which the patient is allocated to receive the     active drug (Kineret®) or placebo (saline). The hypothesis is that anti-IL-1 treatment as     add-on therapy to conventional insulin therapy will preserve or enhance beta-cell function.   "
219046|NCT00711516|"     The primary objective of this study is to determine whether treatment with armodafinil will     provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive     Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.   "
219062|NCT00711724|"     The primary objective is to establish the concurrent validity of the clinician administered     Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS) and the patient administered     Attention Deficit Hyperactivity Disorder Self Report Scale (ASRS) v1.1 Symptom Checklist.   "
219063|NCT00711737|"     The purpose of this study is to explore the changes in metabolic parameters in patients     treated with escitalopram for six months for major depression, generalized anxiety disorder     or panic disorder, with or without agoraphobia.   "
219064|NCT00711750|"     Objectives: Examine the acute utility of immediate maintained cannulations of a newly     implanted prosthetic arteriovenous access. Background: Recurrent failure of central     catheterization is not uncommon. An alternative access is necessary for acute hemodialysis     after the exhaustion of central veins. Methods: We constructed the access by cannulating two     dialysis needle-catheters and securing them on the skin after the implantation of the graft.     The access was used immediately and maintained for one week and thereafter used as a     long-term access.   "
219047|NCT00711529|"     Premenopausal women with breast cancer who receive endocrine therapy (e.g. tamoxifen) and/or     chemotherapy are at risk for experiencing premature menopause because of their treatment. The     resulting symptoms, most notably hot flashes, can cause significant detriment to a patient's     quality of life. Treatment for menopausal symptoms with the gold standard of hormone     replacement therapy is not done routinely as it is unclear whether it can increase risk of     tumor recurrence. In addition, many medical oncologists feel it is contraindicated in this     population, especially among women whose breast cancers have estrogen receptors. This has     lead to an increased interest in options other than estrogen replacement in the treatment of     hot flashes, though most investigations of alternative medications have shown a suboptimal     response.      Recent studies have suggested that non-drug treatments using alternative or complementary     therapies may be effective. Specifically, hypnosis has been promoted as a means to control     hot flashes, though it has not been tested in a randomized fashion. In accordance with the     National Cancer Institute's recent initiatives to expand the goals of clinical trials to     include symptom management studies, our purpose is to evaluate the role of complementary and     alternative therapies for improvement of symptoms in women with breast cancer. Specifically,     we plan to evaluate the use of hypnotherapy for the treatment of therapy-induced hot flashes     in breast cancer survivors. We intend to recruit 60 women into a pilot feasibility trial     comparing hypnotherapy to the drug gabapentin (Neurontin®) for the treatment of     therapy-induced hot flashes in eligible women who are receiving care at the Breast Health     Center. We have chosen gabapentin based on recent studies showing it may be an effective     non-estrogen treatment for this indication.      We will identify patients who are experiencing at least one daily hot flash as a result of     the treatment they received for their breast cancer for participation. When enrolled, they     will be randomized into either the treatment arm, in which they will receive daily     gabapentin, or the experimental arm, in which they will undergo weekly hypnotherapy.      Our study hypothesis is that hypnotherapy will be more effective than gabapentin in the     control of hot flashes in this population.   "
219048|NCT00711542|"     Coronary flow reserve is an important measure of the integrity of the coronary     microcirculation. Moreover, impaired coronary flow reserve is a predictor of future     cardiovascular events and poor prognosis in patients after acute myocardial infarction.      After acute myocardial infarction, coronary flow reserve remains significantly reduced. A     previous randomized, double-blind Placebo-controlled trial (REPAIR-AMI) demonstrated complete     normalization of coronary flow reserve after intracoronary application of autologous bone     marrow-derived progenitor cells (but no effect in the placebo group) in patients with ST     segment elevation myocardial infarction. The current study is planned to extend these     findings to patients with Non-ST segment elevation myocardial infarction, since these     patients have an equally reduced outcome.   "
219049|NCT00711555|"     The purpose of the study is to assess the effect of Emend (aprepitant) on nausea and vomiting     associated with chemotherapy. Chemotherapy commonly causes nausea and vomiting and this     affects patients' quality of life and attitudes toward treatment. Although nausea and     vomiting associated with chemotherapy has been decreasing due to improved therapy, some     patients will still experience this side effect. Therefore, new medications are needed to     decrease the amount of nausea and vomiting patients have with chemotherapy. Emend     (aprepitant) is a new medication used to treat nausea and vomiting with chemotherapy, but it     has only been studied in patients receiving only one dose of chemotherapy that makes most     people sick. However, there is little experience with this medication in patients receiving     multiple days of chemotherapy that causes nausea and vomiting.   "
219052|NCT00711594|"     The objective of the Phase I step is to estimate the MTD at a dose level up to 50 mg/day     (i.e., overseas recommended Phase II dose) in patients with advanced NSCLC and to determine     the recommended dose for the Phase II step.      The objective of the Phase II step is to estimate the efficacy of BIBW 2992 monotherapy in     patients with first generation EGFR-TKI-resistant advanced NSCLC at the recommended dose     determined in the Phase I step.   "
219053|NCT00711607|"     The primary purpose of this trial is to assess the pharmacokinetic profile of NOMAC, E2 and     E1 after multiple and single dose administration of the combined oral contraceptive NOMAC-E2   "
219054|NCT00711620|"     The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe     sepsis.   "
219055|NCT00711633|"     The intestinal flora is a complex ecosystem which is known to play various important     functions in the gut. Recent data have reported a delay in intestinal colonization in     preterm. Modulating the intestinal flora through dietary supplementation with probiotics or     prebiotics has been shown to improve digestive and general outcomes in full-term infants.The     aim of this study was to evaluate the clinical tolerance, the effect on gut microbiota, and     the mucosal inflammatory responses to a fermented milk in preterm infants.   "
219056|NCT00711646|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in     subjects diagnosed with MS and spasticity.   "
219057|NCT00711659|"     The study proposes that a workshop-based educational experience which utilizes a standardized     preceptor training session, a standard skills assessment checklist, and videotaped feedback     will improve student comfort and confidence in performing the pediatric physical examination     and will provide information to improve the curriculum offerings.   "
219058|NCT00711672|"     The purpose of this study is to determine if the degree of agreement between patients and     their physicians regarding the story of the illness correlates with improved patient     symptom control and quality of life. Another goal of the study is to examine the actual     language used by patients and physicians in a specific clinical situation.   "
219059|NCT00711685|"     Sternal or mediastinal infections after heart operation occurs infrequently but carries a     high cost in money, morbidity, and mortality. At our hospital, Staphylococcus species cause     most of these infections and is uniformly sensitive to vancomycin. However, the relative low     concentration of vancomycin in sternal bone was noted given intravenously. Topical vancomycin     was therefore considered to apply on the cut edege of sternal bone before closure in patients     receiving coronary artery bypass graft to evaluate the effect on reducing the infection rate     of staphylococcus related mediastinitis (6). In addition, we try to observe that prophylactic     use of topical vancomycin will increase the risk for acquiring resistant pathogen such as     VISA (vancomycin-intermediate S. aureus), VRSA (Vancomycin-resistant S. aureus), VRE     (vancomycin-resistant enterococcus)   "
219060|NCT00711698|"     This research is being done to find out the best way to give narcotics for pain relief in     adults with sickle cell disease and painful crisis. This study is a comparison of two ways of     giving narcotics. The first way is what occurs now in the Emergency Acute Care Unit (EACU)     where patients are given a single intravenous (iv) dose of a narcotic which is repeated by     the nurse as needed to control the pain. The second way is to provide a single iv dose of     narcotic and then allow the patient to push a button and receive one or more additional doses     of narcotic when he/she thinks it is needed. Our hypothesis is that PCA will be a more     effective way of controlling pain.   "
219061|NCT00711711|"     The purpose of this study is to evaluate the efficiency of manual lymphatic drainage to     decrease the swelling of the knee after total knee replacement surgery   "
219065|NCT00711763|"     The aim of our work is to study the effect of total parenteral nutrition (TPN) cycling in     preterm infants on hypercalcuria (excessive calcium excretion in urine). TPN cycling refers     to administering the TPN over a portion of the day rather than the whole day. Our hypothesis     is that cyclic TPN includes more hypercalcuria in preterm infants as compared to continuous     TPN.      Objectives:      Measure Urinary Calcium(Ca) during the periods of continuous and cyclic TPN.      Compare the amount of Ca losses in the urine continuous vs. cyclic TPN   "
219066|NCT00711776|"     This study is designed to show bioequivalence between Current and New formulation of     Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects   "
219067|NCT00711789|"     The purpose of this study is to determine the effect of a systemic infusion of angiotensin II     on haemodynamics and urine output in critically ill patients with severe sepsis/septic shock     and acute renal failure.      It will also help determine the feasibility of conducting a definitive and adequately powered     randomised controlled trial of angiotensin II in such patients that would assess mortality     and need for renal replacement therapy as endpoints.   "
219068|NCT00711802|"     This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess     the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to     17 years, inclusive, with complicated skin and skin structure infections (cSSSI) caused by     Gram-positive pathogens.   "
219069|NCT00711815|"     This is a research study looking at gene characteristics in blood and Pap smear samples in     hopes of identifying markers that will predict if the HPV infection is present or not.   "
219070|NCT00711828|"     This phase II trial is studying how well giving rituximab and cyclophosphamide together with     bortezomib and dexamethasone (R-CyBor-D) works in treating patients with relapsed or     refractory low-grade follicular lymphoma, Waldenstrom macroglobulinemia, or mantle cell     lymphoma. Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving     rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.   "
219071|NCT00711841|"     Corticotherapy accelerates maternal postpartum recovery in women with class I HELLP syndrome.     The benefit of faster and better recovery would be observed in fewer complications, less     utilization of blood products and shorter hospital stay.   "
219072|NCT00711854|"     MRSA infections often require systemic antibiotic therapy and represent an important     healthcare burden. Currently available treatment options are either only available in     parenteral form (vancomycin) or expensive (linezolid). Thus, there is an urgent, unmet need     to better investigate in-expensive but highly active alternatives to currently recommended     standard treatment options. The purpose of the proposed study is to test the hypothesis that     a combination of TMP-SMX and rifampicin is not inferior to linezolid for treatment of MRSA     infections.   "
219073|NCT00711867|"     The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post     anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System     under general anesthesia for total knee arthroplasty will be equivalent to that of patients     warmed with the Arizant Bair Hugger System.   "
219074|NCT00711880|"     The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in     relieving peripheral neuropathic pain associated with allodynia.   "
219075|NCT00711893|"     The purpose of this evaluation is to assess the acceptance level of specific programming     recommendations based on the patient's clinical needs and primary indications when using the     feature 'Indications Based Programming' (IBP) available in the ZOOMVIEW Software Application     for the TELIGEN DR / VR and COGNIS family of devices compared to daily life programming     chosen by physicians.   "
219076|NCT00711906|"     Malaria is a major contributor of disease burden in Sub-Saharan Africa, and pregnant women     and children are the most vulnerable population. Malaria in pregnancy increases the risks of     abortion, prematurity, maternal anaemia, low birth weight (LBW), perinatal, neonatal and     infant mortality. For prevention and control of malaria in pregnancy, Intermittent Preventive     Treatment (IPT), insecticide treated nets (ITNs) and case management for malaria and anemia     are recommended.      HIV infection in pregnancy increases the risk of malaria, LBW, post-natal mortality and also     of anaemia. In pregnant women, HIV infection decreases the efficacy of IPT with the medicine     sulfadoxine-pyrimethamine (SP), which is the only treatment with proven efficacy and safety     in IPT and is recommended by the World Health Organization (WHO). Unfortunately, there is a     documented increase of resistance to SP, so cotrimoxazole (CTX) could be an alternative: many     studies in Zambia and Uganda demonstrated that it reduces mortality and morbidity in HIV     infected persons, and CTX prophylaxis significantly improves birth outcomes in     immuno-suppressed HIV women. Unfortunately, there is not yet information on its effectiveness     for preventing placental malaria infection, maternal anaemia and LBW. Thus in this study, we     aim to establish the safety and efficacy of daily CTX in preventing malaria infection during     pregnancy and its consequences, both in HIV infected and non-infected pregnant women. This     information is urgently needed to assist to issue guidelines on IPT in pregnancy.   "
219077|NCT00711919|"     This study is aimed to analyze the effects of aggressive and conventional lipid lowering     therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with     hyperlipidemia and abnormal thickening of IMT.   "
219078|NCT00717769|"     The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in     adult subjects with atopic dermatitis   "
219079|NCT00717782|"     Thrombosed external haemorrhoids are one of the most frequent anorectal emergencies. They are     associated with swelling and intense pain. This study evaluated the efficacy and safety of an     intersphincteric injection of botulinum toxin for pain relief in patients with thrombosed     external haemorrhoids   "
219080|NCT00717795|"     The purpose of this study is to learn how many lung cancer survivors will agree to a physical     activity program. We also want to know if lung cancer survivors benefit from this program.     This information will help us to develop our services for lung cancer survivors.   "
219081|NCT00717808|"     The treatment of rheumatoid arthritis has improved considerably in recent years with the     understanding that better outcomes can be achieved by optimising the dosage schedule of     conventional drugs that suppress the inflammatory response in joints. Furthermore, the     development of protein based drugs that are given parenterally (i.e. by subcutaneous     injection or intravenous infusion), known as biologics, have given rise to even better     clinical results. However, despite this over 60% of patients with rheumatoid arthritis can     still be expected to have an unacceptably high degree of disease activity and the     prohibitively high cost of biologic therapy has resulted in rationing following NICE review.     Therefore there is a need for more effective and less costly treatment.      The proposed study is designed to test potential drug interactions between one such candidate     oral treatment, tranilast, and the gold standard therapy for rheumatoid arthritis,     methotrexate, which is given as a once weekly oral, intramuscular or intradermal regimen. The     drug to be tested, tranilast, an analogue of a naturally occurring molecule that regulates     inflammatory responses, is currently used in the treatment of allergic inflammation and has     recently been shown to be effective in an animal model of multiple sclerosis. Tranilast is an     analogue of a naturally tryptophan metabolite. Laboratory studies of cell biology indicate     that this molecule inhibits a number of key inflammatory pathways and the function of white     blood cells that play a critical role in the inflammatory features of rheumatoid arthritis.     The aim of this study is to assess whether tranilast may be useful for the treatment of RA.     In an animal model of rheumatoid arthritis, initial assessment showed that prophylactic     administration of tranilast interfered with the development of disease. Therapeutically, in     an animal model of arthritis, tranilast was very effective, and reduced all aspects of the     disease, including joint swelling, clinical score, and histological damage in a     dose−dependent fashion, and reduced pain. This degree of benefit compares well with     therapeutics that have been highly successful in humans, such as anti−TNF therapy.     Furthermore studies at the Kennedy Institute of Rheumatology Division, Imperial College     suggest that tranilast has a greater analgesic effect than the potent steroid dexamethasone     at effective anti−inflammatory doses   "
219167|NCT00719199|"     Open-label phase 1b trial. Study treatment will be administered in 3 week cycles.      There are two distinct parts in this study:        -  Part 1: Dose escalation from IMO-2055        -  Part 2: Once a recommended phase 2 dose is found additional tolerability and          pharmacodynamics will be explored   "
219082|NCT00717821|"     This 2 arm study will compare the hemoglobin maintenance with once monthly Mircera     administration versus epoetin beta or darbepoetin alfa in patients with chronic kidney     disease on hemodialysis. Patients will be randomized to receive either monthly s.c. or i.v.     Mircera (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of     epoetin beta or darbepoetin alfa previously administered), or standard therapy (iv or sc     epoetin beta once, twice or thrice weekly, or iv or sc darbepoetin alfa once a week or twice     a week). The anticipated time on study treatment is 3-12 months, and the target sample size     is 500+ individuals.   "
219083|NCT00717834|"     The primary objective of this study is to assess the safety and tolerability of the Ross     River Virus (RRV) Vaccine in a healthy young adult population. Other objectives of this study     are to assess the immunogenicity of the RRV Vaccine in a healthy young adult population and     to identify the optimal dose level of the RRV Vaccine in a healthy young adult population.   "
219084|NCT00717847|"     We hypothesize that Epidermal growth factor receptor tyrosine kinase inhibitors modulate     tumor changes that may be reflected in the alteration of serum proteins.      Study objectives are:        -  To establish serum proteomic changes in patients with non-small cell lung cancer (NSCLC)          receiving erlotinib or gefitinib.        -  To identify a serum protein profile that predicts erlotinib or gefitinib sensitivity or          resistance in NSCLC patients with and without EGFR mutations.        -  To study the toxicity of erlotinib or gefitinib by correlating clinical toxicity with          serum protein profile.   "
219085|NCT00717860|"     The purpose of this study is to investigate the safety and efficacy of MK0991 in patients     with deep-seated mycoses.   "
219086|NCT00717873|"     To compare the outcomes of patients treated with the Vest and conventional chest     physiotherapy to determine if the Vest provides equivalent therapy   "
219087|NCT00717886|"     This study is being done to see if lymph nodes that drain the arm also drain the breast. An     axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent     cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are     removed. They are then examined to see if they have cancer cells. Removing these lymph nodes     has some side effects. The most common is lymphedema. This is the build-up of fluid in the     arm. This study will tell us if it may be possible in the future to identify lymph nodes that     just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future     patients.   "
219088|NCT00717899|"     Haifa bay region is located close to a major industrial zone. The aim of the study is to     evaluate the health status of school children living in Haifa bay region.The health status     will be evaluated using health questionnaires and spirometry.   "
219089|NCT00717912|"     The purpose of the study is to determine the glycemic index and the insulinemic index of a     sweetener syrup   "
219090|NCT00717925|"     To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544)     in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).   "
219091|NCT00717938|"     The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will     result in a significant increase of overall survival in patients with small cell lung cancer,     receiving standard chemotherapy.   "
219092|NCT00717951|"     Docetaxol plus capecitabine regimen is the standard treatment for the     anthracycline-pretreated patients with advanced breast cancer. Cisplatin is an important drug     for advanced breast cancer and potential effective drug for triple negative breast cancer.The     study primary objective:Assess ORR,TTP,TTF and 2 year PFS rate between docetaxol+capecitabine     and docetaxol+cisplatin.      The second objective:Assess the safety and QOL.   "
219093|NCT00717977|"     The Juvenile Diabetes Research Foundation (JDRF) Glucose Sensor Study group is carrying out a     large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use     of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma     glucose testing. Although the primary outcome in the >= 7.0% cohort is differences in HbA1c     levels, important secondary outcomes are differences in the percent of glucose sensor values     either above or below the target glucose range of 70-180 mg/dl and differences in glucose     variability. Prevention of biochemical hypoglycemia is a particularly important outcome in     the low HbA1c cohort. Since CGM systems measure interstitial rather than plasma glucose and     CGM values differ from simultaneous plasma glucose values by up to 18%, it would be extremely     useful for comparative purposes to establish a reference range of sensor values in healthy,     non-diabetic control subjects for this study and other future investigations. The objective     of this protocol is to establish such reference sensor glucose ranges in each of the 3     devices being utilized in the JDRF study.   "
219095|NCT00718003|"     The literature to date indicates that noninvasive positive pressure ventilation (NIPPV)     provides effective noninvasive ventilator support, prolongs survival, and improves quality of     life (QOL) in Amyotrophic Lateral Sclerosis (ALS) patients. It is generally recommended to     patients when their pulmonary function testing demonstrates a drop to 50% forced vital     capacity (FVC). One result of using NIPPV may be a reduction in the work of the breathing     which would lead to decreased caloric needs. However, the work of breathing and the effects     of noninvasive ventilation on caloric use have not been studied in patients with ALS. This is     extremely important since there may be a reduction in the caloric needs when ALS patients are     placed on NIPPV and if the caloric intake is not adjusted, overfeeding can occur. Overfeeding     with too many calories can lead to an increase in carbon dioxide which would actually worsen     the respiratory failure.      The overall aim of this project is to evaluate how many calories are used by ALS patients     while at rest, when placed on NIPPV, and when breathing against a resistance. This will be     accomplished using a metabolic cart during these activities. At present, the metabolic cart     is routinely used in ALS patients at the time of feeding tube placement to calculate caloric     needs. Using the cart to calculate the caloric expenditure on and off the ventilator will aid     in calculating the work of breathing and the effects of NIPPV on work of breathing.   "
219168|NCT00719212|"     The purpose of this study is to obtain an estimate of the objective response rate (ORR) of     AMG 479 in patients with recurrent platinum-sensitive ovarian epithelial (including fallopian     tube and primary peritoneal) carcinoma failing frontline chemotherapy.   "
219096|NCT00718016|"     The goal of this project is to determine whether this device is a practical and realistic     means for ALS patients to operate their computers with only the use of facial, brainwave, and     eye movements. This study is intended to evaluate both the complexity of the system and the     degree to which complications of ALS (such as severity of involuntary movements) may     interfere with the use of cyberlink.   "
219097|NCT00718029|"     The purpose of this study is to measure concentrations of Raltegravir in cerebrospinal fluid.      The hypotheses are:        -  Raltegravir concentrations in CSF will be measurable        -  Raltegravir concentrations in CSF will remain constant, while plasma concentrations vary          widely leading to highly variable CSF-to-plasma ratios.        -  Following at least 4 weeks of Raltegravir-containing combination therapy, HIV RNA levels          in CSF will be below 50 copies/mL in all subjects.   "
219098|NCT00718042|"     Protocol designed to test blood samples from blood donors of whole blood and blood components     using a new investigational screening test (PRISM Chagas) that detects antibody to T. cruzi     (Chagas infection). Results will be compared to the current T. cruzi antibody screening     assay. Specimens positive with the screening assay will be further tested with a new     investigational Chagas confirmatory assay [Enzyme Strip Assay (ESA) Chagas]. Additional     specimens collected under separate protocols or sourced from suppliers will also be provided     to the clinical sites for testing with PRISM Chagas assay and ESA Chagas.   "
219099|NCT00718055|"     The purpose of this study is to determine whether MRI with manganese containing contrast     agent detects more livermetastasis compared to CT scan   "
219100|NCT00718068|"     Patients in critical care often require supplemental potassium chloride if levels in their     blood are below acceptable level. Common practice is to administer a single dose of potassium     chloride under controlled conditions via a drip, before checking if a further dose is     required. The purpose of this study is to ensure that it is safe to administer potassium     chloride continuously with the dose varied according to patient needs.   "
219101|NCT00718081|"     The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a     placebo (or sugar pill) for the treatment of post-operative pain in subjects following     abdominal surgery. We hypothesize that subjects receiving placebo will have poor pain relief     and will drop out of the study sooner and more often than the ARX-F01 treated subjects.   "
219102|NCT00718094|"     Green tea consists of several components, with most research focusing on the polyphenol     fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied     extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has     been shown to effectively reduce the inflammation associated with animal models of     inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the     form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.   "
219103|NCT00718107|"     The purpose of this study is :        1. To assess the ALS patient's satisfaction related to a hospital stay on the neurology          floor of Hahnemann Hospital.        2. To compare the reported satisfaction of those individuals who stayed in a standard          hospital room with those who stayed in Room 1455. Room 1455 is a room specifically set          up with assistive technology related to environmental controls for individuals with          disabilities.        3. To look at frequency of use of the various pieces of adaptive equipment.   "
219104|NCT00718367|"     The objective of the study is to determine whether a specific immune microenvironment in the     primary tumor is associated with a favorable clinical course after nephrectomy and in the     absence of adjuvant treatment.   "
219105|NCT00718380|"     The objective of this study is to evaluate the pharmacokinetics, safety and tolerability of     ABT-869 in Japanese patients with solid tumors up to the Recommended Phase Two Dose that was     determined in a previous the M04-710 study.   "
219112|NCT00718471|"     Randomized evaluation of enoxaparin (0.5mg/kg IV) versus UFH (50-70IU/kg with GPIIb/IIIa     inhibitors; 70-100IU without GPIIb/IIIa inhibitors). Anticoagulation can be continued after     the procedure using the same agents as those allocated per randomization (enoxaparin SC, UHF     IV or SC)   "
219113|NCT00718484|"     This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris     administered with doxorubicin in combination, compared with single-agent doxorubicin     administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS).     Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive     palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will     be anthracyclin naïve.   "
219146|NCT00718926|"     Dry eye disease is related with oxidative stress at the ocular surface. GSH is one of the key     factor of protect from oxidative stress. To evaluate thiol status of ocular surface cells by     monitoring GSH concentration, we can evaluate the severity of dry eye.   "
219106|NCT00718393|"     Amyotrophic lateral sclerosis is a uniformly progressive and fatal neurodegenerative disorder     for which there is no known cure. In a novel attempt to widen the search for potential     therapeutic agents, a NINDS- led cooperative group performed an in-vitro screening program of     1040 FDA approved drugs in over 28 assays relevant to various neurodegenerative disorders.     Several cephalosporins showed hits in ALS relevant assays. Efficacy was noted in models     suggesting increased expression of the astrocytic glutamate transporter, EAAT2, as well as     models of superoxide dismutase mediated toxicity. Ceftriaxone is a third generation     cephalosporin with good CNS penetration, a long half-life, and was effective in both types of     ALS assays. Ceftriaxone has calcium binding activity, antioxidant properties, and rescues     motor neurons in culture from chronic glutamate toxicity. Since completion of the original     NINDS screen, Ceftriaxone has been shown to increase by three fold EAAT2 activity in rodent     brains, due to ceftriaxone's ability to increase EAAT2 promotor activation This program is     for the use of ceftriaxone in ALS for compassionate care. Currently ceftriaxone is approved     by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for     treating ALS. However, there is an ongoing phase I study -by NEALS Consortium and the     National Institute of Health- with three cohorts -a placebo group and two groups receiving     either 2 or 4 grams of ceftriaxone daily-. Unfortunately there are only a limited number of     patients being enrolled and the next phase of the project will not be undertaken until next     year. At this point there are ALS patients unable to participate in this Phase I trial and     unlikely to be alive when the next phase of study begins. Some of these patients want to     receive the drug and are willing to pay for the drug and nursing care. We are therefore     requesting a compassionate use protocol for these patients who request the medication and are     willing to pay for the drug and nursing care to administer it. Dr. Terry Heiman-Patterson     will supervise the administration and safety monitoring including labs for renal and hepatic     function as well as IV site inspection.   "
219107|NCT00718406|"     The primary aim was to evaluate the relief of chest pain during the first 30 minutes among     patients who received metoprolol alone as compared with metoprolol plus morphine   "
219108|NCT00718419|"     To determine whether further study of single-agent enzastaurin is warranted in patients with     previously treated Waldenstrom's Macroglobulinemia or Multiple Myeloma based on response.   "
219117|NCT00718536|"     The co-administration of raltegravir with medicinal products that are knouwn to be potent     UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. So once     daily raltegravir (800 mg QD), instead of twice a day (400 mg BID), could be an appropriate     therapeutic option in HIV-infected patients also receiving atazanavir-containing     antiretroviral regimens. In this study, pharmacokinetic data supporting this hypothesis are     recovered.   "
219169|NCT00719225|"     To make belatacept available for recipients of a renal allograft who are currently intolerant     to or have contraindications to CNIs and/or m-TOR inhibitors and are either:        -  unable to construct an adequate immunosuppression regimen due to non-renal toxicity /          contraindication (and withdrawing the causative agent would lead to renal graft loss)      OR        -  at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other          options for renal replacement therapy   "
219109|NCT00718432|"     Frailty, osteoporosis, and depression are three highly prevalent geriatric syndromes. Having     these conditions are associated with adverse outcome in physical health, mental health,     quality of life, and daily functioning. They are associated with higher mortality rates as     well as increased health care cost. Risk factors, pathogenesis, clinical phenotypes, and     interventions of these three geriatric syndromes are often related. Frailty is often defined     as accumulations of multi-system deficiencies with increased vulnerability to multiple worse     outcomes. Multifactorial, interdisciplinary integrated care models targeting frail older     adults may have positive impacts on measurements associated with not only frailty, but also     depression, or osteoporosis. The objective of this proposed study is to conduct a randomized     control trial (RCT) to exam the effectiveness of integrated interventions on multiple     outcomes among community-dwelling Taiwanese elders with high risks for frailty and/or     osteoporosis, depression. We also plan to determine the differential effects of intervention     between urban and rural area.   "
219110|NCT00718445|"     In order to streamline disease research in ALS and other motor neuron diseases, we have     joined a consortium of clinical centers (Hershey and University of Pittsburgh) who will     collaborate on clinical and basic research projects. As part of this collaboration,     de-identified clinical data from subjects at each institution will be entered into a joint     database kindly provided and maintained by the ALS Hope Foundation. This database is password     protected and contains only de-identified information. In addition to clinical data, any     research specimens that are available through IRB approved tissue collections will be linked     to the subject so that the collaborating investigators can share samples and have the maximum     information. This will enhance the usefulness of each specimen.      Once established, the database will provide a resource in which clinical data on a large     number of patients along with tissue (blood, urine, muscle, csf, and autopsy) samples will be     readily available. This will expedite research by circumventing the delays in collecting     specimens prospectively and increase the number of specimens available by allowing the     collaborating researchers access to each others specimens. In each case there will be a     formal request placed to use specimens that are at the other institutions. These specimens     will be used for research in the ALS Center of Hope at the Drexel University College of     Medicine and shared with outside investigators with valid IRB approved protocols.   "
219111|NCT00718458|"     Amyotrophic lateral sclerosis (ALS) is a progressive neuromuscular condition characterized by     weakness, muscle wasting, fasciculations and increased reflexes. Depending on the site of     onset, individuals with ALS progressively lose control of their skeletal muscles; bulbar or     the extremities. As symptoms worsen and spread, muscle atrophy becomes apparent and upper     motor neuron symptoms such as spasticity complicate gait (in lower limb involvement) and     manual dexterity (in upper limb involvement). The patients progress to a state of profound     disability and have great difficulty in communicating; some may even be entirely locked in     to their bodies. The capacity for simple communication could greatly improve their quality of     life.      New technologies are giving people with disabilities alternate communication and control     options. One such instrument is the EEG-based Brain-Computer Interface (BCI) which can     provide both communication and control functions to those who have lost muscle control. By     recording electroencephalographic (EEG) signals or brain waves from the scalp and then     decoding them, the Wadsworth BCI allows people to make selections on a computer screen [i] In     this study we will be investigating the feasibility of using EEG-based Brain-Computer     Interface technology as a communication solution for individuals with ALS. The specific     question addressed will be: Can individuals with ALS use the BCI for communication when they     present with extreme loss of neuromuscular control and severe communication impairments? The     goal of the project is to determine whether this device is a practical and realistic means     for individuals with ALS to communicate. The study is intended to evaluate both the     complexity of the system and the degree to which each participant will be able to     communicate. Trials will consist of asking the subject to follow a series of simple     instructions and complete certain tasks while using the BCI.      This study design requires that the individual live in the Philadelphia region. Please     contact the Wadsworth Center of the New York State Department of Health and State University     of New York at Albany directly if you reside outside of this area.   "
219416|NCT00723320|"     The purpose of this study is to determine whether atorvastatin, aggressive lifestyle     intervention, and their interaction are effective in delaying the progress of pre-clinical     atherosclerosis.   "
219114|NCT00718497|"     New technologies are giving people with motor disabilities alternative communication and     control channels. The investigators are interested in using the Cyberlink Control System as a     hands free means to access a computer for people with Amyotrophic Lateral Sclerosis (ALS).     The goal of this project is to determine whether this device is a practical and realistic     means for ALS patients to communicate with only the use of facial muscle, brainwave, and eye     movements.      The benefit of this study may be of substantial value to many people with severe motor     impairment. Additionally, it is hoped that some of the study subjects may benefit by     incorporating hands-free computer use into their daily lives.      This study is intended to evaluate the effectiveness of the cyberlink as a tool for daily     communication compared to the standard manual letter board.   "
219115|NCT00718510|"     STUDY OBJECTIVES: To determine whether the addition of L-arginine to treatment as usual (TAU)     in schizophrenia further improves and enhances therapeutic efficacy (positive, negative and     depressive symptoms) and effectiveness of antipsychotic treatment      STUDY POPULATION: Patients diagnosed (DSM-IV criteria) with schizophrenia or schizoaffective     disorder      Total expected number of patients: 14      INVESTIGATIONAL COMPOUND: L-arginine capsules, 3 grams of L-arginine given twice a day (total     daily dose of 6 grams/day)      DURATION OF ACTIVE TREATMENT: 3 weeks followed by wash-out phase of 5 days and 3 weeks of     second treatment phase (cross-over design)      EVALUATION CRITERIA: Primary (efficacy) outcomes: PANSS scores. Secondary outcomes: Calgary     Depression Scale for schizophrenia, CGI; AIMS, UKU-assessment of side-effects      ASSESSMENT SCHEDULE: Treatment arm 1: Baseline, weeks: 1,2,3, wash-out phase; week 4,     cross-over phase: treatment phase-2; weeks 5,6,7      STATISTICAL CONSIDERATIONS: Analysis of variance of outcome measures with treatment as the     between-subject factor and pre- and post-treatment scores as within- subjects factors.      DURATION OF STUDY PERIOD: Patient recruitment to be completed in 12 months, study full     completion 18 months.   "
219200|NCT00719628|"     The purpose of this study is to investigate if there is an association between the depth of     anaesthesia and the presence of cognitive deterioration after surgery.   "
219118|NCT00718549|"     This study will assess the effect of maintenance treatment with MabThera,in comparison with a     2 year observation period (no treatment),in patients with progressive B-cell chronic     lymphocytic leukemia who have had previous first-line induction treatment with MabThera (RCC     regimen).After 6 months of induction therapy with RCC (MabThera + cladribine +     cyclophosphamide) patients will be randomized either to receive maintenance treatment with     MabThera (375mg/m2 iv every 12 weeks, or to receive no treatment (observation only).The     anticipated time on study treatment is 2+ years, and the target sample size is 100-500     individuals.   "
219119|NCT00718562|"     This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal     tumors patients who failed imatinib and sunitinib therapy.   "
219120|NCT00718575|"     Standard liver retrieval procedures for transplantation from a deceased donor inevitably     result in a reperfusion injury to the liver tissue. The purpose of this research study is     to find out whether treatment of the liver with a preconditioning protocol before its     removal from the donor will help reduce any of this injury.      The preconditioning treatment being tested has two components. Firstly, a solution of     glucose+insulin is infused and secondly, blood flow to the liver is stopped briefly (10     minutes) and then resumed. Both strategies, individually, have been shown to reduce liver     tissue injury in human studies.      We hypothesize that combining both strategies will have a clinical benefit to patients and     will improve liver function following transplant.   "
219121|NCT00718588|"     This is a Phase I multicenter study that will be conducted in the United States and consists     of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo     controlled MAD stage. The study will be conducted in approximately 65 adult patients between     18 and 80 years old who have RA.   "
219122|NCT00718601|"     The purpose of this study is to determine safety and the maximum tolerated dose (MTD) of     GRN163L and Velcade with and without Decadron when administered to patients with refractory     or relapsed multiple myeloma.   "
219123|NCT00718614|"     There is evidence from a variety of animal studies that choroidal blood flow is under neural     control. Recent results in humans indicate that a light/dark transition is associated with a     short lasting reduction in choroidal blood flow. Several observations indicate that the     changes in choroidal perfusion are triggered at least in part by neural mechanisms.     Particularly, we have shown that during unilateral dark/light transition both eyes react with     choroidal vasoconstriction strongly indicating a neural mechanism for blood flow regulation.     Investigation of changes in choroidal blood flow during light/dark transition may represent     an interesting approach to study neural dysregulation at the level of the eye in patients     with IDDM. Accordingly, the hypothesis of reduced choroidal blood flow responses to a     light/dark transition in patient with IDDM will be tested. This response in choroidal blood     flow will be correlated to parameters of diabetic neuropathy and diabetic retinopathy.   "
219124|NCT00718627|"     Urea cycle disorders are rare inherited diseases that generally have a poor outcome. In this     study, neonates and infants with UCD will be included within the first 3 months of life and     will be treated by repetitive application of human liver cells to reduce the risk of     neurological deterioration while awaiting OLT.   "
219125|NCT00718640|"     The purpose of this study is to evaluate the effectiveness and safety of bortezomib in     participants previously treated for multiple myeloma (cancer of plasma cells in bone marrow     causing numerous tumors and characterized by the presence of abnormal proteins in the blood)     with limited kidney function.   "
219126|NCT00718653|"     Age-related macular degeneration (AMD) is the leading cause of blindness in the United     States. Low dietary intake or low blood levels of lutein and zeaxanthin, which are the only     pigments found in the macular region of the human retina, has been associated with an     increased risk for AMD. We have reported that the dietary supplementation of lutein and     zeaxanthin can increase the macular pigments (MP) of the eye. MP effectively absorbs blue     light as well as quenches reactive oxygen species (ROS). Green tea polyphenols are also     effective scavenger of ROS in vitro.      Our goal is to elucidate how to effectively increase MP by physiologic levels of antioxidant     supplementation. We hypothesize that lutein and tea polyphenols protect the macula of the eye     by increasing MP carotenoids effectively through an antioxidant mechanism.   "
219127|NCT00718666|"     In this study, the concentration of antibody to the vaccine one year, three and five years     after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine     GSK134612 in a previous study (whose objectives & outcome measures are presented in a     separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune     response of a booster dose of vaccine GSK134612 administered at 5 years post-primary     vaccination will also be evaluated. In addition, the immune response to a dose of vaccine     GSK134612 administered to age-matched controls not previously given a meningococcal vaccine     will be evaluated.      This protocol posting has been updated further to protocol amendment 2, dated 28 october     2010. The sections impacted are summary, study design, outcome measures, intervention, and     eligibility criteria.   "
219128|NCT00718679|"     This study is placebo controlled, double blind, randomised, two arm dose escalation of a new     product for specific immunotherapy in cat allergic patients   "
219129|NCT00718692|"     This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label     trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will     receive a single IV dose of Sym001.   "
219130|NCT00718705|"     The purpose of this study is to test the effectiveness of an antibiotic treatment (Josamycin)     in the case of positive PCR for Ureaplasma spp. and/or Mycoplasma hominis in the second     quarter on the risk of premature birth.   "
219131|NCT00718718|"     The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under     the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing     signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate     (MTX) therapy.   "
219132|NCT00718731|"     This is a first-in-humans study of GSI-136, a drug being developed for the treatment of     Alzheimer Disease. The main purpose of this study is to determine whether GSI-136 is safe and     tolerable in healthy young and healthy elderly subjects. The amount of drug in the body and     the effects of the drug on the body will also be evaluated at certain timepoints.   "
219133|NCT00718744|"     The main purpose of the trial is to prove the therapeutic value of the product and enable an     effective and safe dosage schedule to be recommended   "
219134|NCT00718757|"     The purpose of this study is to estimate the maximum tolerated dose of dexamethasone given     for 5 consecutive days when combined with fixed doses of irinotecan (given IV, qd x 5, 2 days     off, qd x 5) and vincristine (given IV, 2 doses total on days 1 and 8 of schedule) in     children with relapsed or refractory hematologic malignancies. In addition we will also study     the pharmacokinetics of irinotecan when given without and then with dexamethasone in each     patient, evaluate the relationship between irinotecan pharmacokinetic parameters and toxicity     and describe any antitumor effects.   "
219135|NCT00718770|"     This study plans to learn more about a drug called bexarotene for the treatment of advanced     thyroid cancer. Subjects are asked to be in this study because they have thyroid cancer that     will not respond to radioactive iodine therapy and shows signs of aggressive behavior.      Bexarotene has been FDA approved for the treatment of a type of skin cancer called cutaneous     T-cell lymphoma, but has not been FDA approved for this use. Bexarotene is investigational in     the treatment of thyroid cancer.      The purpose of this research study is to test how well the study drug works in humans. The     study doctors want to know if:        1. The subjects thyroid cancer gets smaller while you are taking the study drug.        2. The subjects thyroid cancer takes up radioactive iodine better after treatment with the          study drug than before treatment.   "
219136|NCT00718783|"     Retinoblastoma is a childhood tumor of the retina that affects approximately 1 in 18,000     children. Retinoblastoma is more prevalent in Central America, where most patients present     with advanced intraocular and extraocular disease. Therefore, we have formed collaboration     with Central American investigators to provide us with frozen retinoblastoma tumors from     patients undergoing routine enucleation. The objective of this protocol is to begin to     identify the mutations and gene expression changes that occur in retinoblastoma cells     following RB1 gene inactivation in order to more effectively target chemotherapy for treating     bilateral retinoblastoma.   "
219137|NCT00718796|"     This study is designed to test the ability of a comprehensive naturopathic approach to reduce     important risk factors for the development of cardiovascular disease. Treatment will take     place over the course of one year and the comparator/control group will be followed by their     medical doctors and be given conventional care.   "
219138|NCT00718809|"     This phase II trial is studying how well saracatinib works in treating patients with relapsed     or refractory thymoma or thymic cancer. Saracatinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth   "
219139|NCT00718822|"     The purpose of this study is to assess whether reduced oxygen tension in embryo culture has     any effect on clinical outcome.   "
219140|NCT00718835|"     The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such     as methadone or buprenorphine maintenance, is more than three-fold that of the general     population and is associated with increased morbidity and mortality. The overarching goal of     this project is to systematically develop a voucher-based contingency-management (CM)     intervention for promoting initial and longer-term abstinence from cigarette smoking in     patients receiving methadone or buprenorphine treatment for their opioid abuse.   "
219141|NCT00718848|"     Background: Recent data indicate that home nocturnal hemodialysis (8 hours of hemodialysis at     home for 5-6 nights per week) may have substantial cardiovascular benefits, including     regression of left ventricular (LV) hypertrophy, improved LV ejection fraction and blood     pressure control. Nevertheless, this dialysis modality is only feasible in a highly-selected     minority of ESRD patients, who can self-manage their dialysis treatment at home. In-centre     nocturnal hemodialysis (INHD), administered as 7-8 hours of hemodialysis in hospital for 3     nights per week, represents an appealing and practical alternative. As this is a novel form     of therapy, there has been no definitive study examining the cardiovascular impact of INHD to     date.      Objective: To determine the effects of INHD on LV mass, global and regional systolic and     diastolic function, and other cardiovascular biomarkers in patients with ESRD.      Hypothesis: Conversion from conventional hemodialysis to INHD is associated with favourable     changes in cardiac structure and function in patients with ESRD.      Rationale for Using Cardiac MRI: Cardiac magnetic resonance imaging (CMR) has emerged as the     new gold standard for measuring LV mass, volume, global and regional myocardial function. Its     accuracy and precision make it the imaging modality of choice for studying the small number     of patients currently undergoing or awaiting INHD.      Study Design and Population: This is a prospective cohort study of adult ESRD patients who     are currently receiving conventional in-centre hemodialysis and will be converted to INHD.     Patients will be managed as per standard clinical practice (e.g. blood pressure, anemia     management) established for the INHD program, and no therapeutic intervention will be     performed as part of this study. All eligible patients will undergo two serial CMR     examinations: within 2 weeks prior to conversion and at 52 weeks following conversion to     INHD. We also plan to recruit a population of control patients who have elected to remain on     conventional HD. These individuals will be asked to undergo the same set of investigations at     baseline and 12 months thereafter.      Outcome: The primary endpoints are the temporal changes in LV mass and size, global and     regional diastolic and systolic function at 52 weeks after conversion to INHD, as measured by     cardiac MRI. Secondary endpoints include changes in myocardial tissue characteristics, blood     pressure, mineral metabolic parameters, anemia control, serum troponin, norepinephrine, brain     natriuretic peptide, markers of inflammation and quality of life.      Significance: The provision of an enhanced dialysis regimen has emerged as the most promising     avenue through which to modify the dismal cardiovascular outcomes in patients receiving     chronic hemodialysis. INHD represents a means of administering such therapy to a broad     spectrum of dialysis patients for whom home therapies would not be feasible. The proposed     study will be the first to precisely define the cardiac impact of INHD using CMR. The     findings may justify large randomized controlled trials evaluating clinical outcomes. If INHD     is proven to be effective, it will have a major impact on the management and outcome of many     patients with ESRD in Canada.   "
219142|NCT00718861|"     This second extension will evaluate the efficacy and long term safety of zoledronic acid in     women with post-menopausal osteoporosis   "
219143|NCT00718874|"     A diet (42% carbohydrate) specialized to the unique metabolic characteristics of peripubertal     African AMerican girls (hyperinsulinemic, low insulin sensitive) will be more effective in     maintaining glucose and insulin homeostasis compared to a standard diet (55% carbohydrate)   "
219144|NCT00718887|"     Switching to Entecavir will result in superior antiviral efficacy as compared to continuing     with Adefovir in patients with a suboptimal response to Adefovir   "
219145|NCT00718913|"     This study will determine the feasibility of adjuvant chemotherapy and chemo-radiotherapy for     patients with surgically resected adenocarcinoma of the stomach and gastro-esophageal     junction.   "
219545|NCT00725010|"     The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new     concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a     routine care setting.   "
219147|NCT00718939|"     The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind     trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be     followed up to one year post implant.   "
219148|NCT00718952|"     The purpose of this study is to evaluate the efficacy and safety of vardenafil in the     treatment of pulmonary arterial hypertension.   "
219149|NCT00718965|"     The present study is aiming at assessing the efficacy and safety of AVE5530 (25mg and 50mg)     in a double-blind comparison with placebo in the management of patients with primary     hypercholesterolemia. The main objective is to evaluate the effects of AVE5530 on LDL-C level     reduction as adjunct to a controlled diet. The effects of AVE5530 on other lipid parameters     will be assessed as secondary objectives.   "
219150|NCT00718978|"     The aim of this work was to present the investigators experience in the use of autologous     three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes,     melanocytes and fibroblasts attached to a scaffold of hyaluronic acid. This method represents     a surgical alternative in the treatment of a variety of pathologies, including burns, ulcers     and giant nevi.   "
219151|NCT00718991|"     This investigation is designed to assess the immediate and long-term angiographic patency     outcomes of excimer laser recanalisation followed by PTA in the treatment of long (>50 mm)     infrapopliteal lesions in patients with critical limb ischemia (CLI)      The Spectranetics Turbo elite™ excimer laser catheters are percutaneous intravascular devices     constructed of multiple optical fibers around a guidewire lumen. The laser catheters transmit     ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to the obstruction in     the artery. The ultraviolet energy is delivered to the tip of the laser catheter to     photo-ablate fibrous, calcific and atheromatous lesions, thus recanalizing diseased vessels.   "
219152|NCT00719004|"     The purpose of this study is to study normal sonographic(ultrasound)anatomy of the soft     tissues of the foot in normal volunteers.   "
220523|NCT00731094|"     The purpose of the study was to examine the effectiveness of an expert-system, print-based     physical activity (PA) intervention delivered to Veterans receiving primary care at the VA     Pittsburgh Healthcare System (VAPHS).   "
219153|NCT00719017|"     Recent findings have suggested that laparoscopic surgery is safe and effective, as well as     laparotomic one, for treating patients with early stage endometrial cancer (ESEC). Moreover,     our long-term previous data have shown a trend in vaginal cuff recurrence in subjects who     underwent laparoscopic approach to ESEC consisting of extrafascial hysterectomy, bilateral     salpingo-oophorectomy, pelvic +/- para-aortic nodes dissections, regardless grading or     lymphovascular space invasion.      Based on these considerations, the aim of the current protocol-study will be to compare two     different strategies for vaginal cuff recurrences prevention in patients affected by ESEC     treated with laparoscopic surgery. In particular, upper vaginectomy followed by observation     will be compared to post-operative brachytherapy.   "
219154|NCT00719030|"     The purpose of this study is to compare the effects of pomegranate polyphenol pills (POM-X)     and a placebo (sugar pill) on prostatic oxidative stress. The placebo is a pill that looks     like the POM-X pill but does not have an active ingredient.   "
219155|NCT00719043|"     The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is     immunogenic and safe when given to adults aged >=18 years.      This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009.     The impacted sections are study design and outcome measures.   "
219156|NCT00719056|"     This is a prospective, open-label, randomized clinical trial where patients were administered     prophylaxis for total hip or knee arthroplasty either with teicoplanin or with other     antibiotics. The study is aiming to evaluate any differences between these two different     strategies of antimicrobial prophylaxis in the occurrence of surgical site infections   "
219157|NCT00719069|"     This is a single dose inpatient and outpatient study to test whether an effect on the ability     of platelets to stick to white blood cells in subjects who smoke.   "
219158|NCT00719082|"     Falls are the greatest cause of accidental death in the elderly. There is no normative data     on large groups of geriatric subjects specific to their stability scores obtained by     computerized dynamic posturography (CDP). CDP is the standard test to obtain stability scores     and is utilized as the gold standard in posturographic evaluations and fall prevention      Hypotheses:      Human stability can be measured by CDP. Increased stability is associated with a lessor     probability of falls. Stability decreases as age increases and a normative data collection of     stability scores in the geriatric population will allow and promote clinical applications     which can be utilized in fall prevention.   "
219159|NCT00719095|"     There has been an alarming increase in abuse of prescription opioids in recent years. This     project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse     that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine     detoxification and naltrexone maintenance.   "
219160|NCT00719108|"     The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard     to its total and to its maximum serum insulin concentrations.   "
219161|NCT00719121|"     The purpose of this exploratory trial is to assess the anti-inflammatory effect(s) of topical     R115866 in a model of UVB-induced inflammation and in a model of cutaneous irritation.   "
219187|NCT00719459|"     The primary objective of this study is to assess the bioequivalence of the test product     Hospira Iron Sucrose 20 mg/mL (Hospira, Inc.) to the reference product Venofer® 20 mg/mL     following intravenous administration to healthy subjects.   "
219188|NCT00719472|"     This was a prospective, open-label, Phase III, multicenter, single-arm trial designed to     assess the safety, pharmacokinetics, and pharmacodynamics of an alternative dosing rate of     rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and     follicular non-Hodgkin lymphoma (NHL).   "
219189|NCT00719485|"     This study evaluated the hypothesis that the implementation of an educational program that     informs spine patients about their condition, treatment options, prioritization on the wait     list, and post-operative care would improve functional outcome and quality of life scores     following surgery   "
219190|NCT00719498|"     The purpose of this study is to test the possible neuroprotective effect of early high dose     erythropoietin alpha after out of hospital cardiac arrest (OHCA).   "
219191|NCT00719511|"     Evaluation of patch as specific immunotherapy in allergic patients   "
219162|NCT00719134|"     Evidence-based medicine depends on distinguishing between pharmacological effects and placebo     effects in randomized controlled trials (RCT). This proposal seeks to rigorously investigate     fundamental questions concerning pharmacological effects, placebo effects and their     interactions. Relief of symptoms of acute migraine will be the test condition for this     scientific experiment because of migraine's evident clinical significance and the possibility     of using participants as their own control during sequential acute migraine attacks. Our     overall goal is to elucidate how the pharmacological effects of 100 mg rizatriptan (an     FDA-proven effective medication for acute migraine) and the effects of placebo treatment can     be modified by varied knowledge and/or expectation (contextual) conditions. Such knowledge     has the possibility to suggest potentially more efficient methodologies to test new     medications that can be used to augment and enhance the apparatus of the RCT.      General Aim: To elucidate and clarify what is a pharmacological effect and what is a placebo     effect, how such effects vary in different knowledge/expectations contexts, and mutually     constitute one another and interact.      General Hypothesis: The measured pharmacological effect of an effective medication     (rizatriptan) and the measured effect of placebo treatment are determined significantly by     different knowledge/expectations contexts.   "
219163|NCT00719147|"     The primary purpose of this study is to compare the incidence of AVN in children with     hematologic malignancies treated with prednisone versus dexamethasone during continuation.   "
219164|NCT00719160|"     We have established that dietary protein is an important regulator of intestinal calcium     absorption in humans. However, we do not understand the mechanism by which dietary protein is     affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether     dietary protein-induced changes in gastric acid secretion explain the observed changes in     intestinal calcium absorption.   "
219165|NCT00719173|"     RATIONALE: Antiemetic drugs, such as aprepitant, may help lessen or prevent nausea and     vomiting in patients undergoing chemotherapy.      PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works     compared to placebo in preventing nausea and vomiting in patients undergoing chemotherapy for     breast cancer.   "
219166|NCT00719186|"     The primary research hypothesis is that ovulation induction with an aromatase inhibitor     (letrozole) is more likely to result in live birth than ovulation induction with a selective     estrogen receptor modulator (clomiphene citrate) in infertile women with PCOS. A safety     hypothesis will also be incorporated into the primary research hypothesis in which we     hypothesize both treatments are equally safe for mother and child.      Secondary research hypotheses include:        1. Treatment with letrozole is more likely to result in singleton pregnancy compared to          treatment with clomiphene citrate. Singleton pregnancy is defined as presence of a          single intrauterine gestational sac with a single fetal pole and observable heart          motion.        2. Treatment with letrozole will less likely result in a first trimester intrauterine fetal          demise than treatment with clomiphene citrate. A first trimester IUFD is defined as a          pregnancy that ends before 13 weeks gestation.        3. Treatment with letrozole is more likely to result in ovulation (increased ovulation          rate) compared to treatment with clomiphene citrate. Ovulation is defined as a midluteal          progesterone level ≥ 3 ng/mL.        4. The shortest time to pregnancy will be with letrozole.        5. Age, body mass index, SHBG, testosterone, LH, Anti-Mullerian Hormone (AMH), and degree          of hirsutism and acne will be significant predictors of ovulation and conception          regardless of treatment.        6. Improvement in SHBG, testosterone, AMH, and LH levels will be significant predictors of          ovulation and conception regardless of treatment.        7. DNA polymorphisms in estrogen action genes will predict response to study drug.        8. Quality of Life will be better on letrozole than clomiphene.        9. Letrozole will be more cost effective at achieving singleton pregnancies than          clomiphene.   "
221115|NCT00739414|"     This study will characterize the safety, tolerability, biological activity, and     pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has     progressed despite standard therapies, or for whom no standard therapy exists.   "
219170|NCT00719238|"     The long term goals of this project are to develop and implement a combined prenatal and     postnatal intervention to decrease early childhood caries. The program is based on risk     assessment, diet intervention and counseling. To accomplish these goals a pilot study is     needed to determine: 1) The ability to recruit and retain pregnant mothers in an intervention     program; 2) The levels of S. mutans in pregnant mothers; 3) The ability of a diet     intervention to decrease S. mutans in pregnant mothers.   "
219171|NCT00719251|"     The purpose of this study was to compare the effects of high voltage pulsed current and low     level laser therapy on the healing process of diabetic foot ulcers.   "
219172|NCT00719264|"     To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to     bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic     carcinoma of the kidney.   "
219173|NCT00719277|"     The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring     system.   "
219174|NCT00719290|"     The aim of the study is to determine which is the best treatment for people with cataract and     primary angle closure (PAC).In PAC, apposition of the iris tissue to the drainage channels     (Trabecular Meshwork-TM) of the eye results in damage and formation of adherences between     these structures (Peripheral anterior synaechiae-PAS) causing a mechanical obstruction of the     aqueous outflow via the TM. It is thought that cataract surgery combined with mechanical     separation of the iris from the TM with the breakage of PAS(we call this separation     'goniosynechialysis') would make the pressure even lower as it would cause the drain to open     to a greater extent than cataract surgery alone. This technique is not new, and the results     have been very encouraging. Comparing this technique to cataract surgery alone however, has     not been done and this is exactly what we would like to do in order to help us decide what is     the best treatment.      In summary, the investigators propose that cataract surgery with goniosynechialysis would     lower intraocular pressure to a greater extent than cataract surgery alone in patients with     significant PAS.   "
219175|NCT00719303|"     This randomized phase III trial studies whether changes in diet and physical activity can     increase the length of survival without the return of cancer (progression-free survival)     compared with usual care in patients with previously treated stage II, III, or IV ovarian,     fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program     and counseling may help patients make healthier lifestyle choices. It is not yet known     whether changes in diet and exercise may help increase progression-free survival in patients     with previously treated cancer.   "
219176|NCT00719316|"     The central hypothesis of this project is that Aliskiren causes a substantial decrease in     MSNA in hypertensive patients with CKD.   "
219192|NCT00719524|"     The purpose of this study is to determine the recommended dose of the combination of AVE8062     with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in     patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of     care.   "
219177|NCT00719329|"     Background: In developing countries, many babies are born at home and the umbilical cord     commonly becomes infected during the first week after birth, and can be deadly. Cleansing of     the cord with a low-cost antiseptic like chlorhexidine may reduce the risk of these     infections. Little is known, however, about the frequency of chlorhexidine cleansing needed     to impact upon the overall presence of bacteria on the stump, or regarding the changes in     bacteria during the first week of life when most cord infections occur.      Objectives: We will describe the profile of bacteria colonizing the umbilical cord stump of     infants in rural Bangladesh and examine the role of topical chlorhexidine in altering     colonization and progress of infection. We will compare the overall and bacteria-specific     rate of colonization of the cord stump between infants receiving chlorhexidine cleansing of     their cord through the first day or first week of life. We will also quantify the     relationship between colonization of the cord stump with specific pathogens and the presence     and severity of signs of umbilical cord infection (pus, redness, swelling) among these     newborns.      Potential Impact: More information is needed on the impact of single versus repeated     applications of chlorhexidine to the cord stump, as the number of cleansing may substantially     influence the feasibility of widespread scale-up in many populations. The data generated from     this proposed study will guide the most appropriate design of this simple intervention and     will help inform specific treatment protocols for effective management of infants with signs     of umbilical cord infections.   "
219178|NCT00719342|"     It has been shown that diffuse luminance flicker increases retinal and optic nerve head blood     flow. This indicates that a neuro-vascular coupling between neural activity and blood flow     exists in the retina as described previously for the brain. Although a lot of mediators such     as NO, pO2, pCO2, H+ and K+ have been proposed, the mechanism of this coupling is still a     matter of controversy. However, it has been shown in an animal experiment, that an increase     in blood flow, evoked by diffuse luminance flicker stimulation is paralleled by decrease in     pO2 in the tissue. In a recently performed study we could show that breathing of 100% O2 did     not influence flicker induced changes in the retina and optic nerve head. However, breathing     of 100% oxygen also leads to a pronounced vasoconstriction of the retinal vessels and in turn     to a increased tension of the vessel wall. Recent evidence indicates that a combination of     92% O2 and 8% CO2 can, at least partially, counteract the vasoconstrictory effect of O2 and     increases tissue pO2. Thus, in this study the investigators set out to investigate the     flicker light induced increase in blood flow under a mixture of O2/CO2 .   "
219179|NCT00719355|"     The purpose of this study is to compare the effects of polestriding (walking with poles) and     traditional walking on physical endurance in subjects with poor circulation in their legs.     Another goal is to evaluate the effectiveness of a walking program in increasing the amount     of oxygen in the calf muscles and therefore improving overall physical activity and quality     of life.   "
219180|NCT00719368|"     Sensory function is different in persistent postherniotomy pain patients than in operated     controls, suggesting this to be a neuropathic pain syndrome. By performing quantitative     sensory testing, the specific changes in pain patients will be revealed, thereby aiding in     designing future treatment trials. MRI scans of the groin regions in pain patients and     control patients will be evaluated by senior MRI specialists assessing potential pathology to     the region (Mesh, inflammation, edema, funicle etc.) Assessors will be blinded to clinical     status, and surgery.   "
219181|NCT00719381|"     The purpose of this study is to determine the effect of pioglitazone on reducing airway     inflammation in cystic fibrosis and characterize the amount and timecourse of pioglitazone     elimination from the body.   "
219182|NCT00719394|"     This is a first-in-human study of GSI-136, a gamma-secretase inhibitor being developed for     the treatment of Alzheimer disease. This study will take place in Japan only and will provide     an initial assessment of the safety, tolerability, pharmacokinetics (PK), and     pharmacodynamics (PD) of GSI-136 after administration of ascending single oral doses to     healthy Japanese male subjects and healthy Japanese elderly male subjects.   "
219183|NCT00719407|"     The purpose of this study is to determine the safety and pharmacokinetics of moderate to high     doses of erythropoietin in newborn infants with birth asphyxia.   "
219184|NCT00719420|"     More than half of the world's population is infected with Helicobacter pylori, a bacterium     that colonizes the human stomach. Although most infected subjects live free of symptoms and     disease outcomes (except superficial gastritis), only a few develop peptic ulcers or gastric     cancer, while some others may develop non-ulcer dyspepsia. Current clinical practice for the     management of peptic ulcer disease includes testing for and treating H. pylori, if present.     Although there are triple therapies that contain 2 antibiotics plus a bismuth compound, a     proton-pump inhibitor, or a H2-receptor antagonist which are effective at eliminating H.     pylori in Europe and North America, these treatments are dramatically less effective in     developing countries. Our recent meta-analysis showed quadruple therapies containing     clarithromycin, amoxicillin, metronidazole and a proton pump inhibitor to be effective in the     presence of clarithromycin or metronidazole resistance. However, this regimen has yet to be     tested in a developing country. Therefore, in the current randomized clinical trial in Pasto,     Colombia, we aim to examine the effectiveness of clarithromycin, amoxicillin, metronidazole     with and without a proton pump inhibitor compared to the Food and Drug Administration     approved 10-day regimen containing clarithromycin, amoxicillin and omeprazole. Since     antibiotic therapy is most effective within a specific gastric pH range, and since mutifocal     atrophy results in damage and loss of the acid producing parietal cells, we will test the     efficacy of our modified therapy stratified by diagnosis of multifocal atrophic gastritis.   "
219185|NCT00719433|"     The goal of this study is to determine whether task-oriented, robot-aided therapy is more     effective than conventional physical and occupational therapy at promoting functional     recovery of the affected arm in chronic hemiparetic stroke patients.   "
219186|NCT00719446|"     Acute lung injury (ALI) is a severe lung condition that causes respiratory failure. The ARDS     Network (ARDSNet) is a National Heart, Lung, and Blood Institute-sponsored network that is     focused on improving treatments for people with ALI and a similar condition called acute     respiratory distress syndrome (ARDS). This study will evaluate participants who were enrolled     in one of three ARDSNet studies to examine how the treatments carried out in the prior     studies affect participants' long-term health outcomes and quality of life.   "
219194|NCT00719550|"     Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally     advanced or metastatic gastric or esophagogastric junction adenocarcinoma.      Primary Objective(s):      Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX.      Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the     addition of AMG 102 to ECX on progression free survival (PFS).   "
219195|NCT00719563|"     RATIONALE: American ginseng may reduce fatigue in patients with cancer. It is not yet known     whether American ginseng is more effective than a placebo in treating cancer-related fatigue.      PURPOSE: This randomized phase III trial is studying American ginseng to see how well it     works in treating patients with fatigue caused by cancer.   "
219196|NCT00719576|"     The objective of this trial is to investigate how the outcome of the treatment with     autologous chondrocytes compares to microfracture technique in patients with symptomatic knee     disease.   "
219197|NCT00719589|"     The purpose of this study is to determine how many patients who have failed treatment with a     sacral lead can achieve good results with a pudendal, patients satisfaction with the results     of each lead, complication rates after pudendal lead placement, and how many patients have     required reprogramming of their device with EMG testing( a more costly procedure).   "
219198|NCT00719602|"     More than 1.5 million deaths of African children under 5 years of age have been due to     Plasmodium falciparum malaria. When HIV and malaria are present as coinfections, they enhance     each other's progression. The primary purpose of this study is to compare the malarial     infection levels in HIV-infected infants and children receiving protease inhibitor (PI)- or     non-nucleotide reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral     therapy (HAART).   "
219199|NCT00719615|"     The purpose of this study is to evaluate Vitamin D levels in thyroid cancer patients with     active disease compared with thyroid cancer patients in remission and patients with thyroid     nodules.   "
219201|NCT00719641|"     This study will test the use of a new device called a segmental stiffening wire (SSW) in     colonoscopy to correct a problem called looping. Colonoscopy is the best test for detecting     early colon cancer and removing growths called polyps, which can become colon cancer.     Sometimes the flexible tube (colonoscope) used in the procedure loops at a certain point as     it advances through the colon, making it difficult to move further and causing the patient     pain from excessive stretching of the colon. The SSW is designed to prevent this by     stiffening the part of the tube that would otherwise form the loop.      Healthy subjects between 50 and 80 years of age and healthy subjects 40 years and older who     have a family history of colon cancer may be eligible for this study.      Participants undergo colonoscopy a day after self-administering a bowel cleansing     preparation. The first part of the procedure is done similarly to that of a flexible     sigmoidoscopy, and no sedation or pain medication is used. The colonoscope is inserted into     the rectum and advanced about one-third the length of the colon. Pain or discomfort should be     mild to moderate cramping and a feeling of having to move the bowels. The subject is asked to     score his or her pain level at this point using a standard pain scale. If there is pain, the     procedure is stopped and an x-ray is taken to determine if the colonoscope has looped. If it     has, the loop is undone and the SSW is used. Another x-ray is then taken to document that the     loop has been prevented with the SSW, and the procedure is completed as per standard medical     practice. Subjects are taken to the recovery area, informed of the test results and then     discharged home in the care of an accompanying adult.   "
219202|NCT00719654|"     The hypothesis of this study is that many plasma proteins are altered in concentration and     structure in preeclampsia and the elucidation of these alterations will add to the poorly     understood pathophysiology of preeclampsia. In this study we will compare the maternal plasma     proteomes of early-onset severe preeclampsia versus healthy controls, compare protein     expression and quantification of the maternal plasma proteome at the time of diagnosis of     EOS-preeclampsia to the plasma proteome of the same affected subject at 48 hours post     delivery and we will verify the placental expression of differentially expressed or     post-translationally modified proteins found in the plasma of women with EOS-preeclampsia.   "
219203|NCT00719667|"     Comparison of two operative techniques (on-pump vs off-pump)of coronary revascularisation of     the best treatment concept for patients older or 75 years old.      Hypothesis: The coronary bypass operation without use of the heart-lung machine     (off-pump=OPCAB) reduces the combined endpoint in comparison with the conventional coronary     bypass operation (on-pump).   "
219204|NCT00719680|"     The purpose of this study is to determine whether a long-term use of a new human     immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary     immunodeficiency.   "
219205|NCT00719693|"     Single-dose, open-label, two-period crossover study of ABT-143   "
219206|NCT00719706|"     The primary objective of this 15-week clinical trial is to test the hypothesis that treatment     with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA),     has significantly greater efficacy than placebo as an augmentation treatment in bipolar     depressed patients who display an incomplete response to conventional treatments.   "
219217|NCT00719849|"     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor     umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It may     also stop the patient's immune system from rejecting the donor's stem cells. The donated stem     cells may replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving cyclosporine and mycophenolate     mofetil before and after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well donor umbilical cord blood transplant with     reduced intensity conditioning works in treating patients with advanced hematological cancer     or other disease.   "
219218|NCT00719862|"     The Purpose of this study is to determine if one allergy medication (0.15% azelastine     hydrochloride) is more effective than Placebo alone   "
219219|NCT00719875|"     The purpose of this study is to determine the safety profile, tolerability, pharmacokinetics     (PK), pharmacodynamics (PD), of oral vorinostat in combination with oral capecitabine given     on days 1-7 and 15-21 of a 28 day cycle in patients with advanced breast cancer, using RECIST     criteria.      This study was originally intended to be a phase 1/phase 2. The protocol was amended to make     this study a phase 1 only.   "
219207|NCT00719719|"     This study will explore the possible cause of unexplained, or idiopathic, anaphylaxis.     Anaphylaxis is a rapid, life-threatening, severe reaction that occurs suddenly after contact     with an allergy-causing substance, usually a particular food, drug or stinging insect. The     allergen triggers mast cells to release several substances, including histamine. Histamine is     responsible for many of the symptoms that may occur, such as flushing, hives, swelling of the     palms and soles or tongue and vocal cords, nasal congestion, itching and tearing of the eyes,     shortness of breath and wheezing, stomach pain, vomiting, low blood pressure, loss of     consciousness, shock, and, rarely, death. Severe episodes of anaphylaxis are treated with     epinephrine (adrenaline), followed by oral antihistamines and steroids. In more than half of     cases of anaphylaxis, a clear cause is not identified. These cases are called idiopathic     anaphylaxis. There is no cure or long-term preventive therapy for patients with recurrent     episodes of idiopathic anaphylaxis.      People between 18 and 55 years of age who have idiopathic anaphylaxis episodes at least 6     times a year (with at least one episode every 3 months) may be eligible for this study.      Participants are evaluated at the NIH Clinical Center with the following tests and     procedures:        -  Medical history, physical examination and blood tests.        -  Bone marrow biopsy. For this test, the skin over the hipbone and the outer surface of          the hipbone itself are numbed with local anesthesia. Then, a needle is inserted into the          hipbone and a small amount of bone marrow is drawn into a syringe. The needle also cuts          a small core of bone marrow, which is removed for analysis.        -  Other tests that may be needed for evaluation of the patient s condition.   "
219208|NCT00719732|"     A prospective evaluation of the visual parameters in a series of patients bilaterally     implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).   "
219209|NCT00719745|"     To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing     primary liver transplantation.   "
219210|NCT00719758|"     The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and     to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120   "
219211|NCT00719771|"     This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis     using the anchor pegged glenoid component and clinical and radiographic evaluations.   "
219236|NCT00720109|"     This phase II/III trial is studying the side effects and how well giving dasatinib together     with combination chemotherapy works in treating young patients with newly diagnosed acute     lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.   "
219251|NCT00720330|"     The investigators are conducting this study to find out if intravenous (injected through the     vein) infusion of lidocaine and ketamine administered with general anesthesia is as effective     as a paravertebral block in lessening pain after surgery and that both of these techniques     are superior to general anesthesia alone in reducing pain immediately after surgery and in     the long-term.   "
219252|NCT00720343|"     This research will test whether consuming additional choline before gynecological surgery     decreases postoperative pain.   "
219212|NCT00719784|"     Vibration Response Imaging (VRI) is novel technology which records breath sounds via     pizo-electric sensors and produces a digital image using a computer algorithm. It is     radiation free and is portable to the patient's bedside. Data exists to show that the     recordings from normal individuals differs from those who have pulmonary pathology. There is     also evidence that recordings have high levels of inter and intra-observer reliability.     However, data on specific VRI patterns for specific pathology is still needed before this can     be used as a diagnostic tool. We aim to perform an open label feasibility trial on inpatient     and outpatient pulmonary patients. Bedside clinical examination and chest auscultation will     be used as the reference gold standard. Other diagnostic modalities that have been used as     part of the patient's usual standard of care will also be used for comparison. Specifically     breath sound progression, the maximal sound energy shape/distribution and the presence of     artifactual sounds will be used to search for patterns that may be used for diagnosis.     Sensitivity and specificity will be calculated for each disease (eg. asthma, emphysema,     bronchiectasis, pneumonia, effusion, pneumothorax, etc)   "
219213|NCT00719797|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Giving combination chemotherapy together with bevacizumab may kill more tumor cells.      PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens     given together with bevacizumab to see how well they work as first-line therapy in treating     patients with metastatic colorectal cancer that cannot be removed by surgery.   "
219214|NCT00719810|"     The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341     (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in     the treatment of complicated skin and skin structure infections.   "
219215|NCT00719823|"     The objective of this study is to provide Maraviroc on a compassionate use basis to     antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent     unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a     viable regimen.   "
219216|NCT00719836|"     This study consists of two phases: the first portion of the study is a Phase 1 dose     escalation study to determine the maximum tolerated dose and the dose limiting toxicities of     SB1518 when given as a single agent orally once daily in subjects with advanced myeloid     malignancies; the second portion of the study is a Phase 2 study to define the efficacy and     safety profile of single-agent SB1518 at the recommended dose in subjects with chronic     idiopathic myelofibrosis (CIMF).   "
219243|NCT00720226|"     Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage     due to smoking. The goal of this study is to determine whether this drug which is also used     to treat hypertension can stabilize or improve lung function in people who have from chronic     obstructive pulmonary disease (COPD).   "
219220|NCT00719888|"     This phase II trial studies how well giving an umbilical cord blood transplant together with     cyclophosphamide, fludarabine phosphate, and total-body irradiation (TBI) works in treating     patients with hematologic disease. Giving chemotherapy, such as cyclophosphamide and     fludarabine phosphate, and TBI before a donor umbilical cord blood transplant helps stop the     growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting     the donor's stem cells. When the healthy stem cells from a donor are infused into the patient     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,     and platelets. Sometimes the transplanted cells from a donor can make an immune response     against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after     transplant may stop this from happening.   "
219221|NCT00719901|"     This phase I/II trial is studying the side effects and best dose of obatoclax when given     together with bortezomib and to see how well they work in treating patients with relapsed or     refractory multiple myeloma. Obatoclax and bortezomib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Giving obatoclax together with     bortezomib may kill more cancer cells.   "
219222|NCT00719914|"     The main purpose of this research study is to try to improve the results of the standard     treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose     of eptifibatide in the emergency room, shortly after arriving. This drug is usually given     through a vein in the arm. However, eptifibatide can also be injected directly into the     heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in     the heart. This new way of giving the drug is being studying.   "
219249|NCT00720304|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib     together with docetaxel and radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well erlotinib given together with docetaxel and     radiation therapy works in treating patients with stage III or stage IV squamous cell     carcinoma of the head and neck.   "
219223|NCT00719927|"     Latinas are more likely to be obese and physically inactive than white women. Therefore, a     behavioral weight loss program for Latinas will be tested in this pilot study. Thirty     overweight or obese Latinas will be recruited for a 12 week weight loss program at the Weight     Control & Diabetes Research Center. Participants will be provided with nutrition and physical     activity education and be taught behavioral skills to help them adopt lifestyle changes that     produce weight loss. Participants will be placed on a reduced calorie diet and instructed to     gradually increase their level of physical activity. To encourage participants to monitor     their daily eating and exercise activities, participants will be instructed to record these     activities in food and exercise diaries and submit them each week. Two treatment groups will     be tested. The first group will have participants attend sessions with a female friend     (comadre). The second group will have participants attend sessions without a comadre. The     aims of this study are to determine whether we can succeed in recruiting Latinas with their     comadres and whether we can reduce participant drop-out by having Latinas participate with     their comadres in a behavioral weight loss program.   "
219224|NCT00719940|"     Test of hypothesis that in contrast to non-treatment tinnitus specific cognitive behavioral     therapy intervention procedures that are manualized and structured within the disease     management program TCP are effective.   "
219225|NCT00719953|"     A Single-Center, Open Label Study to Assess the Efficacy of Cognitex in Elderly Subjects with     Memory Impairment   "
219226|NCT00719966|"     RATIONALE: Aromatase inhibitor therapy is used in treating postmenopausal women who have     hormone-dependent breast cancer. It is not yet known what effect aromatase inhibitor therapy     has on blood vessel function.      PURPOSE: This clinical trial is studying the effect of aromatase inhibitor therapy on blood     vessel function in postmenopausal women with breast cancer.   "
219227|NCT00719979|"     This study will develop and evaluate the effectiveness of a technology-assisted behavioral     intervention, consisting of Internet-based cognitive behavioral therapy combined with     telephone and email support, in reducing depressive symptoms and improving treatment     adherence in primary care patients with major depressive disorder.   "
219228|NCT00719992|"     The aim of this study was to assess the amount of additive value of HS-CRP levels to a     positive exercise tolerance test (ETT) in predicting coronary artery disease (CAD) using     coronary angiography as the gold standard. The investigators concluded that HS-CRP can be     used as a single predictor of coronary vessel involvement in patients with stable angina and     positive ETT.   "
219229|NCT00720005|"     The purpose of this study is to evaluate the visual outcomes and patient satisfaction after     bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare     it to a historical control group of patients implanted bilaterally with the spherical ReSTOR     multifocal   "
219230|NCT00720018|"     The primary objective is to compare the pharmacokinetics (PK) profiles among five NP101     patches in healthy volunteers.      The secondary objective is to evaluate the safety of NP101 in healthy volunteers.   "
219231|NCT00720031|"     Most of HLA-A2 melanomas express Melan-A/MART-1 antigen and are recognized by tumor reactive     Melan-A specific T lymphocytes. By using blood samples from HLA-A2 melanoma patients (stage     III and IV), our goal is to produce a tumor reactive Melan-A specific T cell clones and to     conduct a phase I-II clinical trial, based on the infusion of several millions to several     billions of these lymphocytes to the patient, in order to induce passive immunity against     this antigen. Production of the clones will be performed in the Unit for Cellular and Gene     Therapy from Nantes University Hospital. Therapeutic response, safety treatment but also     localization and survival of infused T cell clones will be assessed. This approach is     expected to precise the ability of the clones to migrate within the tumor and to transfer     specific immunity.   "
219232|NCT00720057|"     To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium     extended-release tablet, compared to placebo in postsurgical dental pain.   "
219562|NCT00718276|"     We compare the effect of HyD (25-hydroxyvitamin D) and vitamin D3 in their effect on     25-hydroxyvitamin D plasma levels over a course of 4 month. This is a pharmacokinetic study     including 35 postmenopausal women.        -  Trial with medicinal product   "
219233|NCT00720070|"     RATIONALE: Imaging procedures, such as PET/CT scan, produce pictures of areas inside the body     and may help doctors detect residual disease and plan the best treatment. Neck dissection is     surgery to remove lymph nodes and other tissues in the neck. It is not yet known whether a     neck dissection should always be performed in treating patients with head and neck cancer.      PURPOSE: This randomized phase III trial is studying PET/CT scan-guided watchful waiting     compared with neck dissection of locally advanced lymph node metastases in treating patients     who are undergoing chemotherapy and radiation therapy for primary head and neck cancer.   "
219234|NCT00720083|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Vandetanib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known     whether giving chemotherapy together with radiation therapy is more effective with or without     vandetanib in treating patients with head and neck cancer.      PURPOSE: This randomized phase II trial is studying giving chemotherapy together with     radiation therapy to see how well it works compared with giving chemotherapy and radiation     therapy together with vandetanib in treating patients with high-risk stage III or stage IV     head and neck cancer.   "
219235|NCT00720096|"     This pilot study will help us to determine the success of using a special technique called     microarray technology to examine cancer genes in order to predict how individual women will     respond to one of two therapies, liposomal doxorubicin or topotecan, and which will be more     effective in treating ovarian cancer that has returned (recurrent ovarian cancer). We believe     that this study may lead to a means by which microarray technology can predict the most     effective treatment decision, based on the genetic characteristics of her tumor tissue, for a     woman with recurrent ovarian cancer.      Another purpose of this study is to determine how quickly a woman with recurrent ovarian     cancer will respond to treatment (treatment response rate) and to evaluate the accuracy of     the genomic predictions.      Recent data suggest that microarray technology can predict a patient's response to     chemotherapy; this has not yet been proven in a forward-looking study which is why we are     conducting this research.   "
219250|NCT00720317|"     To more clearly ascertain the relationship between ocular manifestations of sickle cell     disease and diabetes, specifically; whether the presence of sickle cell trait exacerbates the     disease progression of diabetic retinopathy.   "
219237|NCT00720122|"     Adolescents and young adults with anorexia nervosa (AN) are at high risk for low bone mineral     density at a time when healthy adolescents are rapidly accruing bone, with implications for     peak bone mass and fracture risk in later life. They are also deficient in insulin-like     growth factor 1 (IGF-1), the bone trophic factor made in the liver in response to growth     hormone (GH), despite elevated levels of growth hormone. It is possible that deficiency of     insulin-like growth factor 1, a hormone very important for the maintenance of skeletal     integrity, may contribute to the severe osteopenia seen in anorexia nervosa. The physiologic     effects of recombinant human insulin-like growth factor 1 (rhIGF-1) treatment in adolescents     and young adults with anorexia nervosa have not been studied. The goal of this proposal is to     investigate the effects of recombinant human insulin-like growth factor 1 on bone density and     bone microarchitecture in adolescent girls and young adult women with anorexia nervosa over a     6 month period. We hypothesize that adolescent and young adult anorexia nervosa patients,     being insulin-like growth factor 1 deficient, will respond to exogenously administered     recombinant human insulin-like growth factor 1 with elevations in biochemical indices of bone     turnover and an increase in bone density and improvement in bone structure, or maintain bone     density (in contrast to the decrease in bone density expected in adolescent girls and women     with anorexia nervosa who are not treated).   "
219238|NCT00720135|"     RATIONALE: Biological therapies, such as fusion protein cytokine therapy, may stimulate the     immune system in different ways and stop cancer cells from growing. Monoclonal antibodies,     such as rituximab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Giving fusion protein cytokine therapy together with     rituximab may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of fusion protein     cytokine therapy when given after rituximab in treating patients with B-cell non-Hodgkin     lymphoma.   "
219239|NCT00720148|"     The purpose of this study is to test the effect of the combination of sunitinib and     bortezomib. We will see what effects it has on your cancer and find the highest dose of each     agent that can be given without causing severe side effects.   "
219240|NCT00720161|"     Obesity with insulin resistance in the paediatric population provides an increasing     challenge. Children with neurological or neuromuscular diseases are even more prone to     obesity: their locomotor impairment leads to an increasingly sedentary lifestyle, a decrease     in physical fitness and an increase in body fat (1-3). Obesity, in turn, can be associated     with a decrease in physical fitness and a further increase in body fat. In this study we want     to evaluate the effect of an insulin-sensitizer, metformin, in a group of overweight/obese     patients with neurological or neuromuscular diseases. Metformin is a well-established insulin     sensitizer.   "
219241|NCT00720174|"     This phase I trial is studying the side effects and best dose of cixutumumab given together     with doxorubicin hydrochloride and to see how well they work in treating patients with     unresectable, locally advanced, or metastatic soft tissue sarcoma. Monoclonal antibodies,     such as cixutumumab, can block tumor growth in different ways. Some block the ability of     tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Drugs used in chemotherapy, such as doxorubicin     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving monoclonal antibody cixutumumab together     with doxorubicin hydrochloride may kill more tumor cells.   "
219242|NCT00720200|"     The purpose of this study is to improve care in the Intensive Care Unit (ICU) by focusing on     communication with family members of patients who are too sick to make decisions about their     own care while they are in the ICU. The randomized trial will test the efficacy of a     communication intervention designed to improve communication between families and clinicians     through the use of a facilitator. Outcome evaluation occurs at the level of the individual     family with surveys completed by families and clinicians.   "
219244|NCT00720239|"     The study will test a new wound healing dressing called Taliderm® on leg ulcers caused by     chronic venous insufficiency (CVI). Some people with CVI have poor vein circulation that     causes ulcers to develop on the lower legs. This new dressing is hoped to help the ulcers     heal more quickly. The study hypothesis is to determine whether the TalidermR Wound Dressing,     a poly-N-acetyl glucosamine (pGlcNAc) derived membrane material expedites wound healing in     humans with venous stasis ulcers.   "
219245|NCT00720252|"     The purpose of this study is to measure prenatally with ultrasound the intratracheal flow     volume displaced during breathing cycle in premature fetuses and to check whether a     relationship exists between the inspired fluid and fetal lung maturation.   "
219246|NCT00720265|"     To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf     and MR4 in new kidney transplant recipients   "
219247|NCT00720278|"     The purpose of this study was to determine if two allergy medications are more effective than     placebo.   "
219248|NCT00720291|"     Most studies demonstrate that untreated bacterial vaginosis increases the rate of preterm     birth. Despite this, there is no evidence that screening and treatment of asymptomatic     bacterial vaginosis nor interpregnancy treatment of endometritis decreases the subsequent     rate of preterm birth. However, treatment of symptomatic bacterial vaginosis has been     associated with a modest reduction in subsequent preterm birth. Potential mechanisms for this     reduction include a decrease in peripheral maternal pro-inflammatory activation of the TH1     inflammatory cascade with treatment, however this direct pathway has not been elucidated. The     approved treatment for bacterial vaginosis during pregnancy consists of Metronidazole 500mg     BID for 7 days. A more complete understanding of the effect of Metronidazole on maternal     inflammation would be useful in designing strategies to reduce the rates of preterm birth.      This study proposes to determine the effect of standard treatment of BV carriage on maternal     serum markers of inflammation. This will be accomplished by giving patients with asymptomatic     BV either the standard treatment of metronidazole or a placebo for 7 days. Blood will be     drawn to compare levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha.   "
219253|NCT00720356|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab     together with erlotinib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib     works after radiation therapy and temozolomide in treating patients with newly diagnosed     glioblastoma multiforme or gliosarcoma.   "
219254|NCT00720369|"     We propose to study and compare measures of brain energy metabolism in geriatric bipolar     individuals and healthy older adults. We would also like to investigate changes in brain     energy metabolites and in vivo creatine kinase (CK) enzymatic activity associated with CoQ10     administration in older bipolar individuals.   "
219255|NCT00720382|"     The purpose of this study is to determine if one allergy treatment (0.15% azelastine     hydrochloride) is as safe as mometasone furoate (nasonex) alone.   "
219256|NCT00720395|"     This study will evaluate pregnant women who have bipolar disorder to gain a better     understanding of risk factors for bipolar disorder relapse during pregnancy and the     postpartum period.   "
219257|NCT00720408|"     The purpose of this study is to compare the efficacy and safety of Prograf extended     release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant     recipients   "
219258|NCT00720421|"     The purpose of the study is to determine the effects of the compound AZD7325 as compared to     lorazepam on sleepiness, concentration and brain activity.   "
219259|NCT00720434|"     The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase     inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of     PF-00868554 in combination with current standard of care therapy, pegylated     interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).   "
219260|NCT00720447|"     RATIONALE: Giving chemotherapy and monoclonal antibody therapy before a donor stem cell     transplant helps stop the growth of cancer cells. It also helps stop the patient's immune     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are     infused into the patient they may help the patient's bone marrow make stem cells, red blood     cells, white blood cells, and platelets.      PURPOSE: This phase II trial is studying donor stem cell transplant in treating patients with     mantle cell lymphoma.   "
219261|NCT00720460|"     This study will test new techniques to image the heart, blood vessels, and legs using     magnetic resonance imaging (MRI). The techniques will be used to plan and guide treatments     using minimally invasive methods.      Healthy normal volunteers 18 years of age and older may be eligible for this study.      For MRI, the subject lies flat on a table that can slide in and out of the scanner, a metal     cyclinder. Special antennas, covered in pads, are placed against the subject s body. The scan     time can vary from 20 minutes to 2 hours, with most scans lasting between 45 and 90 minutes.     The subject may be asked to wear adhesive patches on the chest for monitoring the heart and a     belt or finger pad for monitoring breathing. During the test, a contrast agent called     gadolinium may be injected. This substance brightens the heart and arteries during the scan,     providing a better picture of blood flow.      During the procedure, subjects may be asked to exercise their legs on a machine to evaluate     the effects of motion and exercise on the MRI exam.      Large blood pressures cuffs may be placed on either or both thighs or calves to try to     measure arterial flow to the legs. The cuffs are inflated to a pressure as high as at least     50 mmHg higher than thesubject s systolic blood pressure (up to 250 mmHg) for up to 10     minutes.      Subjects may be asked to return for repeated scans.   "
219262|NCT00720473|"     We propose to study the efficacy and tolerability of lamotrigine in the treatment of older     adults with bipolar depression and to compare measures of brain energy metabolism between     older subjects with bipolar depression and healthy age-matched controls in order to better     understand treatment response in geriatric bipolar depression.   "
219263|NCT00720486|"     This study will evaluate the effectiveness of an anger management treatment program, Juvenile     Justice Anger Management for Girls, in reducing anger-related behaviors displayed by girls in     the juvenile justice system.   "
219264|NCT00720499|"     The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL     administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the     Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary     disease (COPD).   "
219265|NCT00720512|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     It is not yet known whether combination chemotherapy is more effective with or without     bevacizumab in treating metastatic colorectal cancer.      PURPOSE: This randomized phase III trial is studying second-line combination chemotherapy to     see how well it works compared with or without bevacizumab in treating patients with     metastatic colorectal cancer who have received first-line chemotherapy and bevacizumab.   "
219266|NCT00720525|"     Over the past few years, there has been a growing appreciation that a large number of     patients with heart failure have a relatively normal (or preserved) ejection fraction     (NFNEF). Epidemiologically, HFNEF is most prevalent among elderly women, most of whom have     hypertension, diabetes, or both and often coronary artery disease (CAD). Increased arterial     stiffness and/or wave reflections have been described in the same patient groups. Therefore,     the investigators speculate that pulsatile hemodynamics, representing arterial stiffness     and/or arterial wave reflections, 1) may be altered in HFNEF patients, 2) this may contribute     to pathophysiology of HFNEF, and 3) this may be used for the diagnosis of the syndrome.   "
219281|NCT00720733|"     An intervention designed to increase positive affect in a population newly diagnosed with HIV     will be effective at improving affect and HIV-related outcomes such as mental and physical     health, coping and coping resources.   "
221116|NCT00739440|"     The purpose of this study is to compare the efficiency and safety of the treatment against     sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum   "
219267|NCT00720538|"     Several open-label studies reported thalidomide efficacy in inducing clinical remission and     steroid tapering in refractory Inflammatory Bowel diseases (IBD), both in adults and in     children.      This is a randomized placebo controlled (RCT) double blind study, to evaluate the efficacy of     thalidomide in inducing clinical remission at 8 weeks in refractory IBD patients aged 2-20     years.      The primary hypotheses of the study is that thalidomide would be more effective than placebo     in inducing clinical remission.      The RCT phase is followed by a open-label phase, to further evaluate efficacy and safety of     thalidomide in thalidomide responders, with a total follow up of one year.   "
219268|NCT00720551|"     The aim of this study is to calibrate the STISIM driving simulator under influence of three     different dosages of ethanol (0.05%, 0.08% and 0.11% BAC). The levels of performance     decrement for the three blood alcohol concentrations will serve as a standard for comparing     the effects that will be observed with psychoactive drugs in future trials. This will make     the results of these future studies more easily to interpret and will provide health care     providers and policy makers who read our scientific work with an easy-to-understand and     clinically relevant comparison.   "
219269|NCT00720564|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as arsenic trioxide and temozolomide, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Arsenic     trioxide and temozolomide may also make tumor cells more sensitive to radiation therapy.     Giving radiation therapy together with combination chemotherapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide     when given together with temozolomide and radiation therapy in treating patients with newly     diagnosed high-grade glioma.   "
219270|NCT00720577|"     Part A. The purpose of this study is to assess the effects of 6 weeks of treatment with,     simvastatin, losartan or pioglitazone compared to placebo on the RNA expression profile of     lower extremity peripheral arterial atherosclerotic plaque. Part B. The effect of     simvastatin, losartan or pioglitazone compared to placebo on protein and lipid biomarkers in     lower extremity peripheral arterial atherosclerotic plaque.   "
219271|NCT00720590|"     HIV protease inhibitors (PIs) are a class of antiretroviral drugs used to inhibit viral     replication. They do so by interfering with a key step in the replication process. Some HIV     PIs have been associated with an increased risk of adverse cardiovascular side effects.     Further study is needed, however, to assess the full extent of effect of newer HIV PIs,     including atazanavir and lopinavir/ritonavir, on cardiovascular disease risk. This study will     compare the effects of atazanavir, lopinavir/ritonavir, and placebo on certain cardiovascular     disease risk factors in healthy people without HIV.   "
219272|NCT00720603|"     The purpose of this program is to provide expanded access to plerixafor for patients with     NHL, HD, or MM who are to receive treatment with an autologous peripheral stem cell     transplant.   "
219273|NCT00720616|"     Study hypothesis:      Low dose growth hormone (GH), through its generation of free 'bioavailable' insulin-like     growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of subjects     with metabolic syndrome.      Study aims:      The purpose of this study is to determine the mechanism of how low dose GH treatment affects     the body's sensitivity to insulin actions and whether this low GH dose can affect the body's     handling of steroid hormone levels (cortisol clearance) and fat deposition in subjects with     metabolic syndrome.      Study design: Subjects that satisfy the criteria of metabolic syndrome (central obesity,     treated or untreated high blood pressure, high cholesterol and impaired fasting glucose     levels) will be invited to participate in this study. The subjects will be assessed at the     initial visit to ascertain their suitability before further participation in the study. If     eligible, an equal number of men and women will be randomized (like a flip of a coin) to     receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging     over for another 12 weeks of treatment after a 4-week washout period. Before, during and     after treatment, the subjects will be assessed at frequently with blood tests, scans and fat     biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and     Translational Research Institute (OCTRI). At the first, second and final visit, testing will     include scans to measure the amount of whole body fat and fat in the stomach area, muscle,     and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy)     analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by     growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in     the body (insulin sensitivity) will be collected at all visits of the study.   "
219840|NCT00722020|"     To determine whether or not high frequency chest wall oscillation (in the form of the VestTM)     is superior to regular asthma therapy in the management of children hospitalized with     moderate to severe asthma.   "
219274|NCT00720629|"     The purpose of this study was to test whether a new drug named visilizumab would decrease the     severity of graft-versus-host disease in patients treated with a mismatched donor.     Investigators planned to use visilizumab in combination with tacrolimus and methotrexate as     the study treatment.   "
219275|NCT00720642|"     To confirm that a definitive diagnosis can be made from the tissue sample collected using the     Intact BLES when defined radiology and pathology criteria are met.   "
219276|NCT00720655|"     The aim of the study is to examine the effects of fatty fish and white (lean) fish on     cardiovascular disease risk factor levels in subjects with established coronary heart disease     using multiple medications. The main end points are blood pressure, serum lipids,     inflammatory markers, arrhythmias and gene expression in peripheral mononuclear cells. The     study design was a controlled, parallel study lasting 8 weeks with three diet groups: fatty     fish, white fish and control group (lean pork, beef or chicken).   "
219277|NCT00720668|"     This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous     radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.   "
219278|NCT00720681|"     The purpose of this study is to review our experience with the operative management of acute     diaphyseal fractures of the humerus via an anterolateral approach with the use of small     fragment fixation at a Level I, urban, trauma center. We will report our clinical and     radiographic results, complication rate and final range of motion. A standardized outcome     measurement (DASH) will be reported. Muscle recovery of the triceps and biceps will be     evaluated by a standard protocol, accomplished with the assistance of a licensed physical     therapist. We hypothesize that open reduction and internal fixation of humeral diaphyseal     fractures via an antero-lateral approach with the use of small fragment fixation is a safe     and efficacious way to treat multiple trauma patients with these injuries.   "
219279|NCT00720707|"     The aim of this study is to compare the clinical outcomes of root coverage procedures, using     coronally advanced flap in combination with acellular dermal matrix with or without enamel     matrix derivatives .   "
219280|NCT00720720|"     The objective of this exploratory study is to analyse in humans any qualitative changes of     carotid artery atherosclerotic plaque under the influence of plant sterols consumption.   "
219282|NCT00720759|"     Each year 730,000 Americans experience a stroke. Forty percent are left with significant     paralysis of one arm. Certain types of physical therapy, for example constraint induced     movement therapy (CIMT), have been shown to be effective in improving arm function. However,     for most subjects, improvement is modest. In this trial, we test two approaches that may     increase the amount of improvement achieved: 1) distributing treatment over a greater amount     of time; and 2) adding a drug, d-cycloserine, which theoretically enhances the molecular     mechanisms of learning.   "
219283|NCT00720772|"     The present study will examine the treatment effect of sodium thiosulfate on coronary     calcification in patients on hemodialysis.   "
219284|NCT00720785|"     Natural killer (NK) cells are white blood cells that have a limited ability to kill cancer     cells. This ability might be enhanced if they are given 24 hours after an injection of the     drug bortezomib. This study will determine the following:        -  What dose of NK cells can be given safely to subjects with metastatic solid tumors or          leukemia.        -  The effectiveness and side effects of NK cell therapy        -  How the body handles NK cells.      People between 18 and 70 years of age who have a solid tumor or leukemia, and for whom     standard treatments are not effective, may be eligible for this study. Participants undergo     the following procedures:      Apheresis to collect NK cells. For this procedure, a catheter (plastic tube) is placed in a     vein in the subject s arm. Blood flows from the vein into a cell separator machine, which     separates the white cells from the other blood components. The white cells are extracted and     the rest of the blood is returned to the body through a second tube placed in a vein in the     other arm.      Chemotherapy with the drug pentostatin to suppress the immune system and prevent it from     attacking the NK cells that will be infused.      Chemotherapy with bortezomib to increase NK cell function.      Infusion of the NK cells. In this dose-escalating study, successive groups of patients     entering the study receive increasingly higher numbers of cells to determine the highest safe     dose level. Up to four dose levels may be studied.      Interleukin-2 drug therapy to maintain NK cell activity.      Evaluations during therapy including:        -  Clinical assessment, history and review of medications        -  Blood draws for routine and research tests.        -  Pharmacokinetics study after the NK infusion to see how the body handles the cells. For          this test, the number of NK cells in the blood are measured over time. This requires          drawing about 1 teaspoon of blood at 15 minutes, 30 minutes, 1, 2, 4, 8, 12, and 24          hours after the infusion (day 1); then every 24 hours on days 2 through 7, then once on          days 10, 14, and 21.        -  Bone marrow biopsy (subjects with leukemia only).        -  Chest x-ray.        -  CT scan, bone scan and PET scan, if indicated, for disease evaluation.      Subjects who respond well after one treatment cycle may be eligible to continue NK cell     therapy.   "
219285|NCT00720798|"     This single-arm study evaluated the long-term efficacy and safety of tocilizumab in     participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche     protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol     WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in     combination with standard anti-rheumatic treatment.   "
219286|NCT00720811|"     This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The     primary activity of the study wil be a two armed cluster randomised trial in two study sites     in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic     and the other meso-endemic for malaria. In one arm the children will be treated presumptively     for malaria with ACT (control arm) and the other arm the children will receive ACT only when     they have a positive RDT result (implementation arm). The children in the implementation arm     will also receive antibiotics if they have a raised respiratory rate. The primary outcome     will be the recovery rate in the intervention arm compared to that of the control arm on Day     3. In addition, an acceptability assessment of RDTs in the community will be undertaken both     before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy     will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to     demonstrate comparable levels of endemicity in control and intervention groups. These     activities will be carried out over a two year period.   "
219287|NCT00720824|"     A combination of topical anesthetic, plastic arm gripper, visual focusing task and hypnotic     suggestions will reduce the discomfort associated with immunization of pre-kindergarten aged     children.   "
219288|NCT00720837|"     The goal of this clinical research study is to learn about a new therapy device called the     Visualase® Thermal Therapy System (a device that uses a laser to kill tumor cells and is     guided using magnetic resonance thermal imaging [MRTI]). The Visualase® Thermal Therapy     System is used to treat metastatic brain tumors. Researchers want to find out if it is     possible to use this new device in patients with metastatic brain tumor(s), each measuring 3     centimeters (cm) or smaller. The safety of the device will also be studied.   "
219289|NCT00720850|"     The hypothesis of this study is that lenalidomide can be an effective drug in preventing     relapse of MDS and AML patients with chromosomal abnormalities involving monosomy 5 or del5q     after allogeneic HSCT. Due to its immunomodulatory action it might also be able to enhance a     T - or NK cell mediated graft versus leukemia (GVL) effects. Nevertheless, one has to keep in     mind a possible, yet unknown influence on modulation of clinical GVHD.   "
219290|NCT00720876|"     RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Giving vorinostat     together with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects of giving vorinostat together with     rituximab and to see how well it works in treating patients with indolent non-Hodgkin     lymphoma.   "
219291|NCT00720889|"     The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when     people sleep. However, it is still not known if differences in the amount of nighttime sleep     have an effect on the carbohydrate metabolism of people who have a relative with type 2     diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis     that individual differences in habitual sleep duration may be related to differences in the     carbohydrate metabolism of people who have a history of type 2 diabetes in their family.   "
219292|NCT00714753|"     RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor     to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This phase II trial is studying the side effects of internal radiation therapy when     given with or without external-beam radiation therapy and to see how well it works in     treating patients with localized prostate cancer.   "
219293|NCT00714766|"     Heat stress reduces the central blood volume and causes orthostatic intolerance. The     hypothesis is that infusion of volume may reduce effects of orthostatic stress during heat     stress.   "
221117|NCT00739453|"     Multicenter, open-label, phase 1, cohort dose escalation study to determine the Maximum     Tolerated Dose (MTD) of OSI-906 in combination with erlotinib   "
219294|NCT00714779|"     In this study we compare two treatments for major depression - fluoxetine and brief     psychodynamic psychotherapy. In addition to more traditional outcome measures, we also     measure the densities of 5HT-1A and D-2 receptors before and after the treatment. The main     hypothesis is that brief psychotherapy is as effective as fluoxetine.   "
219295|NCT00714792|"     The purpose of this study is to look for evidence of bacteria in the urine or bladder of     people with overactive bladder. Because you do not have overactive bladder, your     participation in this study will be used as a comparison to those who have overactive     bladder.   "
219296|NCT00714805|"     Recent evidence implicates abnormalities of autonomic function in ALS including problems with     gastrointestinal (GI) motility. GI complaints reported by ALS patients such as constipation,     diffuse abdominal pain, and a feeling of fullness or nausea may be attributed to autonomic     involvement. Toepfer et al. found delayed gastric emptying in most ALS patients, indicating     autonomic dysfunction (Gastrointestinal dysfunction in amyotrophic lateral sclerosis.     Amyotrophic Lateral Sclerosis Other Motor Neuron Disord 1999; 1:15—19). The same authors also     reported markedly prolonged colon transit time in ALS (Toepfer et al: Delayed colonic transit     times in amyotrophic lateral sclerosis assessed with radio-opaque markers. Eur J Med Res     1997; 2:473—476).      The present study will investigate the GI transit time in a large cohort of patients and     controls using a noninvasive technique that measure hydrogen gas production with the     digestion of lactulose in a measured substrate load presented to the bowel.   "
219297|NCT00714818|"     Women with a close relative who has experienced mental illnesses like schizophrenia, bipolar     disorder or schizoaffective disorder often have a poor understanding of the causes of the     illness, and are often very worried about the chance that any children that they have will     become affected with the same illness. Often, because of this fear, these healthy women     choose not to have children.      Genetic counseling is a process where information about the causes of illnesses, and about     chances for family members of individuals with these illnesses to become similarly affected     is provided in a supportive environment by a specially trained healthcare professional. This     study will investigate whether genetic counseling can reduce perceptions of risk and stigma,     and increase perceived control and knowledge about the causes of the illness, amongst women     who have a first degree relative with a major mental illness.   "
219298|NCT00714831|"     Declining physical activity and the associated rising burden of disease is a major     public-health problem and it has long been known that being physically active has positive     health effects. The virtual absence of a public health practice infrastructure for the     promotion of physical activity at the local level presents a critical challenge to control     policy for chronic disease. We aimed to assess the efficacy of a 3-months physical activity     program in primary health care to create adherence to physical activity in sedentary     individuals.   "
219299|NCT00714844|"     The purpose of the study is to investigate the weight-sparing effect of detemir and assess     glycemic control and treatment satisfaction when switching from NPH to detemir, to improve     metabolic control.   "
219300|NCT00714857|"     Dexmedetomidine is a new, highly selective and potent alpha2-adrenoreceptor agonist     registered for sedation of patients in intensive care units. Although the pharmacokinetics of     dexmedetomidine have been studied previously also in an ICU setting, there is no information     on the pharmacokinetics of long-lasting (>48 hours) dexmedetomidine infusions in humans.      The aim of this study is to study the pharmacokinetics of long-lasting dexmedetomidine     infusions in ICU patients using the population pharmacokinetics approach.   "
219313|NCT00715026|"     This is a post-approval study with prospective enrollment in the United States and a     retrospective enrollment outside the United States to obtain functional, quality of life and     radiographic data, which will facilitate assessment of the clinical performance of the Zimmer     Trilogy AB Acetabular Hip System.   "
219314|NCT00715039|"     The study is to assess the performance characteristics of a new measure to assess onset of     efficacy in a GAD patient population.   "
219909|NCT00731640|"     Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or     phakic eye.   "
219301|NCT00714870|"     We are currently experiencing an epidemic of obesity in the Pediatric Population. This     epidemic affects many areas including quality of life.      We have been conducting a nutrition and exercise program since 2003. We have noticed that     many of the participants seem to have a better quality of life after finishing the one year     program compared to when they started. We would like to objectively quantify this improvement     using a validated questionnaire at the beginning and at the end of the study. Questionnaires     will be given to participants and to their caretakers at the same time. There will be two     groups in the study: one intervention (minimum attendance of 4 sessions) and one control     group.   "
219302|NCT00714883|"     The primary objective of this study is to evaluate the target lesion failure rate of the NEVO     Sirolimus-eluting Coronary Stent System.   "
219303|NCT00714896|"     Examine the efficacy of a stepped-care smoking cessation intervention for current and former     smokers in chemical dependency treatment programs. We hypothesize that those who received the     stepped-care intervention will be more likely to report smoking abstinence and drug or     alcohol abstinence at 6 months.   "
219304|NCT00714909|"     In order to avoid to use a traumatic and iatrogenic examen (phlebography), the purpose of the     study is to validate echography doppler in the diagnosis of asymptomatic related catheter     related thrombosis.   "
219305|NCT00714922|"     The objective of the study is to compare clinical outcomes from PRK and SBK using     FDA-approved laser technology in the same patient   "
219306|NCT00714935|"     Decision Aids (DA) to inform patients about health care options and help them to participate     in their care choices are widely advocated. The main argument for offering patients a choice     is that patients' preferences vary, and health professionals cannot always know what is     best for an individual, specially when different outcomes have different benefits and risk     profiles. The standard modes of treatment for patients with coronary artery disease (CAD) are     coronary artery bypass graft (CABG) surgery, medication, and angioplasty. All three     treatments for CAD work better when combined with cardiac risk factor modification behavior     (CRFMB). CRFMB is important for the general public, but it is even more important for people     with CAD because people with CAD have more at stake. In this RCT study we will evaluate the     effectiveness of a CAD-DA with and witout an additional decision counseling program (DCP) on     health outcomes and quality of life to improve enhancement of adherence to cardiac risk     modification behavior. The CAD-DA is developed by the Ottawa Health Research Institute and     Division of Clinical Epidemiology at Montreal General Hospital, for CAD patients facing the     decision of making lifestyle changes to lower their cardiac risk factors. It provides     patients with information about what they can you do to prevent the disease from progressing.     The DCP is designed to systematically guide patients through the process of deciding what     cardiac risk modification behaviors are important for them to carry out. A RCT where 360 CAD     patients > 18 of age scheduled for an angiogram at Rikshospitalet University Hospital in     Norway (RH) will be randomly assigned to: (1) CAD-DA group where subjects will receive, for     take home, the CAD-DA prior to their scheduled angiogram; (2) DCP group where subjects in     addition to the CAD-DA will receive an individual decisional counseling program (DCP) from a     trained nurse counselor in their homes prior to their angiogram; and (3) the control group     who will receive usual care. Data will be collected at four points: at the initial visit     (T1), 2 months (T2), 4 months (T3) and 6 (T4) months after angiogram   "
222867|NCT00770107|"     Working Hypothesis: a treatment with thiamine improves functional status and heart function     of patients with congestive heart failure when on a diuretic treatment.   "
219307|NCT00714948|"     Standard chemotherapy drugs generally work by killing rapidly dividing cells in your body.     Cancers cells are some of the most rapidly dividing cells and that is why chemotherapy can be     effective in some patients. Gemcitabine and Cisplatin are an effective and standard drug     combination used to treat locally advanced and metastatic urothelial cancer. However, these     drugs do not shrink tumors in all patients and when they do, it is generally for a limited     amount of time. This has led scientists to look for different ways to treat cancer.      New drugs have been developed to treat cancer that work differently than standard     chemotherapy drugs. These drugs attempt to decrease the blood supply to tumors. By doing so,     this may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing.     Sorafenib is an example of a drug that works in this way.      In some patients with advanced kidney cancer, sorafenib alone has been shown to slow the     progression of their disease. The purpose of this study is to find out what effects, good     and/or bad, the combination of gemcitabine, cisplatin, and sorafenib has on you and your     cancer.   "
219308|NCT00714961|"     The purpose of this study is to determine if the combination of aspirin plus clopidogrel is     more effective than aspirin alone in preventing another heart attack, chest pain, stroke or     death in people who have already had a heart attack that was treated with fibrinolytic     therapy.   "
219309|NCT00714974|"     This is a prospective, randomized, blinded study in which patients will be enrolled into     either treated(BIS group) or untreated (non-BIS) group employing bispectral analysis to     measure the level of sedation/analgesia in patients receiving neuromuscular blocking agents.      To collect pertinent data on critically ill patients while they are receiving NMBA's. In     particular to correlate sedation/analgesic medication needs between a group whose medication     use is determined by the values obtained by bispectral analysis to a group who will have     medications delivered by the standard of care presently used in the intensive care unit in     which they are being treated.      To document that patients who are monitored with bispectral analysis are able to achieve an     appropriate level of consciousness in a shorter time and require less manipulation and     amounts of sedative or analgesic medications than those who are not monitored.   "
219310|NCT00714987|"     -  ARDS is a severe pathology with high mortality and morbidity.Actual ventilatory          management is clear for the set of the tidal volume and for the survey of the plateau          pressure for the patients who require mechanical ventilation.        -  The set of the PEEP (low or high levels) remains unclear : it seems that some patients          need low levels of PEEP whereas anther need high levels; but there is no validated data          that can discriminate them.        -  We hypothesized that patients with low levels of EVLW ( measured with the Picco® system          ) need low level of PEEP to ameliorate their oxygenation ( measured with the PaO2/FiO2          ratio ) whereas patients with high levels of EVLW) need high levels of PEEP.   "
219311|NCT00715000|"     This prospective randomised study comparing administration of a hypo-osmolar oral hydration     solution with the classical hydration via IV (intravenous) infusion in premature infants of     more than 32 weeks GA (gestational age) aims to determine whether administration of a     hypo-osmolar oral hydration solution is as efficient as intravenous infusion.   "
219312|NCT00715013|"     Patupilone trial for patients with recurrent glioblastoma, which are planned for     re-operation. Objectives: prolongation of PFS compared to patients with re-operation only,     Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone.     Translational research of tumor tissue exposed to patupilone.        -  Trial with medicinal product   "
219315|NCT00715052|"     Traumatic brain injuries (TBI) are a major cause of morbidity and mortality worldwide. Due to     improvements in emergency medical care, transportation and specialized trauma facilities, the     number of people surviving TBI with impairment has significantly increased in recent years.     The long term cognitive sequelae, which are often not visible persist far beyond the     resolution of the obvious physical disabilities. This combined with the relatively low     awareness of the general public has designated TBI as the silent epidemic (TBI CDC 2006).     Hyperbaric oxygen therapy (HBOT) has been suggested as a possible treatment modality for     these cases and preliminary studies are promising.      The purpose of this study is to evaluate the effectiveness of HBOT in the treatment of     chronic mild traumatic brain injuries (mTBI). Sequential SPECT scans of the brain and     neurocognitive testing will be used to evaluate cerebral blood flow (CBF) response, cognitive     and functional improvement following treatment.   "
219316|NCT00715065|"     We plan to study patient who faint in response to the sight of blood and compare them to     healthy subjects who do not. We are going to use a special type of MRI scan (functional MRI)     to determine if there are differences in brain activation in response to seeing bloody or     gory pictures that occur before the fainting occurs.   "
219317|NCT00715078|"     This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with     metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with     different concentrations of PA2024 antigen   "
219318|NCT00715091|"     This is a randomised, controlled, multi-centre clinical trial on AS patients. Experimental     intervention: continuous (daily) treatment with diclofenac cholestyramine 150 mg (Voltaren     Resinate), divided into 75mg Voltaren twice dailyControl intervention: treatment on-demand     (as needed) with diclofenac-cholestyramine 75 to 150 mg (Voltaren Resinate). The treatment     strategy of the control intervention (on-demand) reflects current clinical practice in AS.     Duration of intervention per patient: 2 years Follow-up per patient: safety assessment 3     months after termination of the trial.   "
219319|NCT00715104|"     This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant     treatment in men with localized prostate cancer.   "
219332|NCT00715273|"     Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls     of arteries. This study will examine the effectiveness of a combination of     cholesterol-lowering medications at decreasing the fat content of atherosclerotic deposits in     people who have coronary artery disease or carotid artery disease.   "
219320|NCT00715117|"     It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing     endogenous enkephalin levels in subjects with active Crohn's disease. This is especially     important in children who often are suffering from nutritional deprivation which retards     their growth.      The key objectives are to:        1. Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using          the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers,          weight, and pediatric quality of life survey.        2. To determine the safety and toxicity of low dose naltrexone in pediatric subjects with          active Crohn's Disease.        3. Assess the potential mechanism by which naltrexone exerts its action by measuring plasma          opioid (enkephalin and endorphin levels) and proinflammatory cytokines.   "
219321|NCT00715130|"     H1: The increase in body mass index between baseline and two year follow-up among     intervention worksites will be lower than that among control worksites, such that the     differential change will be negative on average.   "
219322|NCT00715143|"     The purpose of this study is to collect and evaluate long-term safety and effectiveness data     on the Exactech® NOVATION ™ Ceramic Articulation Hip System (NOVATION ™ Ceramic AHS). Ten     (10) years of follow-up data will be collected in this study. The first five (5) years of     subject follow-up will involve clinical (Harris Hip Score, adverse events), radiographic, and     self-assessment evaluation. The remaining five (5) years of subject follow-up will be     accomplished with an outcomes questionnaire that will be completed by the subjects to     evaluate the survivorship status of their hip replacement.   "
219323|NCT00715156|"     This study is aimed at verifying the role and the efficacy of the recombinants allergens Pru     p 1, Pru p 3 and Pru p 4, Bet v 1, Bet v 2 and Bet v 4 in the diagnosis of peach allergy   "
219324|NCT00715169|"     This study is a, randomized, double-blind, placebo-controlled phase 2a trial evaluating the     potential of MLN1202 to reduce circulating levels of C-reactive protein (CRP)in patients with     risk factors for Atherosclerotic cardiovascular disease (ASCVD). Patients with risk factors     for ASCVD will be screened for inclusion and exclusion criteria including assessment of     C-reactive protein. If the patient's CRP is greater than 3.0 mg/L on repeated measurements at     least 2 weeks apart, the patient will be enrolled, stratified by screening CRP levels (≤5.0     mg/L and >5.0 mg/L), and randomized to receive 1 dose of either placebo or MLN1202. Safety     will be assessed by vital signs, physical examination, clinical laboratories at baseline, and     adverse event (AE) reporting from Day 1 to Day 113 of the trial.   "
219325|NCT00715182|"     This is a phase I/II open-label study to delineate the safety, efficacy, pharmacokinetics     (PK) and pharmacodynamics (PD) of TKI258. The eligible subject population consists of     subjects who have been diagnosed with advanced or metastatic renal cell cancer that is     refractory to standard therapy or for which no curative standard therapy exists.   "
219326|NCT00715195|"     Comparison of two treatments of fibromyalgia; the QOL score should improve rather and, twelve     months after the end of the program, remain higher in Plurifocal educational group than in     control group   "
219327|NCT00715208|"     This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the     safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a     combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone     (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone     (VELCADE-R-CP) based on investigator preference. Following completion of the treatment     period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.   "
219366|NCT00722631|"     There is increasing evidence that inflammation plays a role in progression and     destabilization of atherosclerotic plaque. FDG-PET can visualize activated metabolic activity     of inflammatory cells. It is possible that FDG-PET can detect atherosclerotic plaque     inflammation and that FDG-PET can monitor the effect of pioglitazone on plaque inflammation.   "
219328|NCT00715221|"     We are proposing a clinical investigation of the pathogenesis of insulin resistance (IR) in     skeletal muscle and adipose tissue (AT), focusing specifically on the contributions of     glucose delivery, transport and phosphorylation. The primary methodology will be dynamic PET     imaging, using three tracers that respectively portray the kinetics of glucose delivery,     bi-directional trans-membrane glucose transport and glucose phosphorylation. The three     tracers are: 1) [15O]-H2O for quantifying tissue perfusion, this portrays the kinetics of     glucose delivery from plasma to tissue; 2) [11C]-3-O-methyl glucose, a tracer constrained to     bi-directional trans-membrane glucose transport; and 3) [18F]-fluoro-deoxy glucose, which     like [11C]-3-OMG is transported, but adds the subsequent metabolic step, that of glucose     phosphorylation.      We propose 2 specific aims to apply this methodology to investigate the pathogenesis of IR.     The 1st aim is to quantitatively assess the kinetics of glucose delivery, transport and     phosphorylation in skeletal muscle in type 2 DM and as compared to obese and lean     non-diabetic men and women. We will appraise the contribution of each step to the to the     pathogenesis of IR. We postulate more severe IR in oxidative muscle, with a dual impairment     of glucose transport and phosphorylation. The 2nd aim is to implement the triple-tracer     dynamic PET imaging protocol in adipose tissue (AT), examining normal insulin action in     non-obese volunteers and testing whether differences in AT insulin action are present in     obese insulin sensitive volunteers compared to obese IR participants and the relation of AT     IR to that of muscle and liver.   "
219329|NCT00715234|"     A study team with extensive experience in immunization delivery research will evaluate the     effectiveness of vaccination reminder/recall systems for adolescent patients in five types of     clinical settings including: urban pediatric, urban family medicine and rural family medicine     practices, public pediatric clinics, and school-based health centers. Randomized controlled     trials of reminder/recall for adolescents will be conducted at each type of site, with     randomization at the level of the patient.   "
219330|NCT00715247|"     The purpose of this project is to find genes whose mutations cause Polycythemia Vera,     Essential Thrombocythemia and Primary Myelofibrosis.   "
219331|NCT00715260|"     The purpose of this observational study is to better understand the natural history/natural     course of uremic pruritus (UP) - itching associated with chronic kidney disease(CKD). During     the lifetime of a CKD dialysis patient, UP tends to be a prolonged, frequent, and an intense     itch that is known to impair the patient's quality of life (QoL), including sleep and mood.      The study will follow hemodialysis (HD) patients longitudinally to characterize their     pruritus over time. The study will quantify and characterize UP and assess change over time;     collect data on conditions that may be affected by UP such as sleep, mood, socialization and     overall quality of life; collect data on use of medications, particularly anti-pruritic     treatments, sleep aids, and medications for depression and anxiety; and collect data on     medical resource use, particularly hospitalizations for treatment of skin and other     infections over the duration of the study.   "
219334|NCT00720902|"     This protocol will assess the cardiovascular risk associated with growth hormone deficiency     in adults. We will use multiple modalities to assess risk for heart attacks or strokes     including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are     growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize     that adults with growth hormone deficiency will have results suggestive of an increased risk     for cardiovascular disease.   "
219335|NCT00720915|"     The purpose of this study is to determine if the risk of recurrent venous thromboembolism     (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked     proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of     therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.   "
219336|NCT00720928|"     Objectives:      To describe the safety and efficacy of intravitreal flucinolone acetonide implants in the     management of patients having refractory ocular Behcet's disease      Hypothesis:      A descriptive observational study      Study design:      A 1-year, multi-center (including four Korean medical centers) observational study   "
219337|NCT00720941|"     This study is being conducted to provide a direct comparison of the efficacy, safety and     tolerability for pazopanib and sunitinib (SUTENT)   "
219338|NCT00720954|"     The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle     biopsy by the diagnostic efficacy and safety in patients with pleural effusion.   "
219339|NCT00720967|"     The purpose of this study is to determine whether preoperative hemodialysis or intraoperative     modified ultrafiltration are effective for patients with non-dialysis dependent severe renal     dysfunction undergoing open heart surgery.   "
219340|NCT00720980|"     Granuloma annulare is a benign, usually self-limiting, cutaneous dermatosis, which typically     presents as asymptomatic, flesh-colored or red papules, frequently arranged in an annular     pattern on the distal extremities. Although localized granuloma annulare is most commonly     observed, a generalized or disseminated form can occur. The etiology of granuloma annulare is     unknown, however, multiple inciting factors have been proposed. The purpose of the     investigators is to review the outcomes of treatment of granuloma annulare (GA) resistant to     standard regimens that resolved after a 3-months treatment course of monthly rifampin,     ofloxacin, and minocycline (ROM) therapy, successfully used to treat paucibacillary leprosy,     a disease with clinical and histopathologic similarity to GA.   "
219341|NCT00720993|"     The purpose of this study is to evaluate the gene expression patterns from colorectal mucosal     cells collected through the use of a standard anoscope and cytology brush. Patients will     include those scheduled for routine colonoscopy procedures and those with confirmed     colorectal cancer.   "
219375|NCT00722748|"     This proposal puts forward a research plan to initiate a genetic databank, henceforth     referred to as The Genebank at Scripps Clinic Registry. This database will usher in genomic     research at Scripps as we strive to stay at the forefront of cardiovascular research in the     new century. Human subject donation allows for the creation of the proposed genebank.   "
219417|NCT00723333|"     We will evaluate the records of 30 patients that have undergone allogeneic transplant,     specifically looking at engraftment rate, relapse rate, disease free survival, overall     survival, causes of death and other pertinent statistics. We will compare the outcomes to     appropriate historical controls.   "
219342|NCT00721006|"     The purpose of this research study is to compare in patients with double-sided claudication     if the transplant of a combination of stem cells obtained from the bone marrow of the same     patient will contribute to the formation of new blood vessels in one of the severly diseased     ischemic limbs(legs)versus the control limb that receives a placebo product.      Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood     flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain     and even skin ulcers or sores.      LI needs comprehensive treatment since the condition will not improve on its own. The overall     goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the     leg and feet. In many cases, current options for treatment including medications, surgery or     endovascular procedures have not been successful.      In the last few years, investigators have explored therapies aimed to increase blood flow to     the ischemic vessel by transplanting cells that will promote the development of new vessels     in the diseased leg.      The study hypothesis is based on the concept that the process of formation of new blood     vessels is complex and requires the participation of several types of stem cells and growth     factors. The lack of any of these components will produce vessels which are immature and     unable to provide appropriated blood supply to the leg.      Patients eligible to participate in the this study are those suffering from double-sided     claudication with poor circulation or severe leg blockages, which are not candidates for     surgical procedures.      Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will     be transplanted into the calf muscle of one the the diseased legs while the other diseased     leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem     cell transplant will be performed for six months post cell transplant.   "
219343|NCT00721019|"     The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when     people sleep. However, it is still not known if differences in the amount of nighttime sleep     have an effect on the carbohydrate metabolism of people who have a relative with type 2     diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis     that the carbohydrate metabolism of people who have a history of type 2 diabetes in their     family will be different after they have slept short hours for 10 days in comparison to when     they have slept longer hours for 10 days.   "
219344|NCT00721032|"     Ventricular tachycardia (VT) is a morbid arrhythmia responsible for many sudden deaths and     ICD shocks. Despite much progress in the treatment of arrhythmia, VT remains a therapeutic     challenge. Most patients with VT have an implantable cardioverter defibrillator (ICD) for     secondary prevention of sudden cardiac death, however, an ICD merely treats VT, it does not     prevent VT. In patients with recurrent VT and ICD shocks, two strategies are available to     decrease the burden of VT. The first is antiarrhythmic drugs, and the second is VT ablation.     The aim of this study is to compare the efficacy of antiarrhythmic drugs and VT ablation     guided by MRI. VT can sometimes be suppressed with antiarrhythmic medications, however, these     are often ineffective, and carry a high burden of side effects. Many forms of VT can be cured     by selective destruction of critical electrical pathways with catheter ablation. A major     limitation in the ablation of VT, however, is the time required to localize scar tissue and     important pathways for targeting of lesions. Magnetic resonance imaging can now obtain     reliable images of scar location within the ventricles. Recent advances in electroanatomical     mapping systems allow operators to import pre-acquired images into the mapping system. The     aim of this study is to examine the feasibility of importing historic MRI scar maps of the     ventricles into the electroanatomical system and using such images to guide catheter     ablation, as compared to antiarrhythmic drug suppression of VT. We suspect that MRI guidance     will be especially useful in patients with unstable VT, i.e. VT that causes an abrupt drop     in blood pressure, and thus cannot be maintained in the electrophysiology (EP) lab for     mapping and entertainment purposes. Patients referred for VT ablation have ICDs. Through     previously completed animal work (Circulation 2004; 110(5): 475-82) and a human trial (2006     Sep 19;114(12):1277-84) we have demonstrated the safety of MRI in the setting of pacemakers     and implantable defibrillators using appropriate precautions. Through careful device     programming and using MRI sequences with limited energy exposure (specific absorption rate <     2 W/kg) we will study the pre procedural myocardial anatomy of patients enrolled into this     study.      The primary endpoint will be lack of VT documented by implantable defibrillator (when     present) interrogation or Holter monitoring 6 months post ablation. The secondary endpoints     will be comparison of inducible arrhythmia at the end of the procedure, procedure time,     comparison of endocardial voltage mapping to scar on delayed enhancement MRI images, and     complications in each study arm.   "
219345|NCT00721045|"     This is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability     of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in     subjects who have cardiomyopathy of both ischemic and idiopathic etiology.   "
219346|NCT00721058|"     Rationale: Whole breast irradiation with 50 Gy after lumpectomy has been shown to reduce the     local recurrence rate with a factor 3 to 4. An additional boost of 16 Gy to the tumorbed has     been shown to improve the local control rate even further. However, this boost dose appears     to reduce not only the local recurrences in the tumorbed, but also elsewhere in the breast,     suggesting that the boost may not always be delivered at the correct region. In addition,     even with the boost dose of 16 Gy, the local recurrence rate in young patients is still quite     high - with the majority of recurrences in the tumorbed. Consequently, further improvement of     the local control, especially in young women, is still an important aim to pursue, in order     to maintain breast conserving therapy (BCT) as an acceptable treatment option in young women.     One way to improve local control may be to increase the dose [Young Boost Trial], but also to     improve the definition of the tumorbed, i.e. the target volume for boost irradiation.      Objective: The aim of this study is to investigate the effect of incorporating a     contrast-enhanced (CE)-CT-thorax in the target volume delineation process on 1) the coverage     of the tumorbed by the 85% isodose, 2) the size of the irradiated boost volumes, and 3) the     interobserver variation in target volume delineation.      Study design: A CE-CT scan of the thorax will be made prior to surgery, with the patient in     radiation treatment position. After breast conserving surgery, patients will be referred for     post-operative radiotherapy according to the standard guidelines. Prior to radiotherapy, a     standard CT thorax scan will be made for treatment planning.      The planning target volume (PTV) for the boost will be delineated according to the MAASTRO     protocol, by three independent observers (PTV-1A-C), using the planning CT only. Delineation     of the boost will be repeated after 3D registration of the pre-operative CT scan with the     planning CT-scan (PTV-2A-C). Thereafter, consensus will be obtained for the PTV-1A-C and the     PTV-2A-C, resulting in one PTV-1 and one PTV-2 for each patient. Radiation treatment plans     (RT-plans) will subsequently be designed for PTV-1 and PTV-2. Coverage of the treatment plans     by the 85% isodose for both PTV-1- and PTV-2, and the irradiated volumes (percentage of the     volume receiving 95% or more (V95)) will be calculated. Patients will be treated with the     treatment plan for PTV-2.      Study population: 60 breast cancer patients, to be treated with BCT, with a mass visible on     mammography and/or ultrasound > 0.5 cm, without contraindications for a CE-CT-thorax scan     will be included.      Intervention: < 3 weeks prior to lumpectomy a CE-CT-thorax scan will be made of the entire     thorax, with the patient in the same position as planned during the post-operative     radiotherapy. Intravenous contrast will be given according to the standard thorax protocol of     MAASTRO clinic.      Main study parameters/endpoints:      Primary endpoints are:        1. The percentage of the PTV-2 receiving < 85% of the dose, if treated with the RT-plan for          PTV-1.        2. Difference in V95 for the RT-plan designed for PTV-1- versus for PTV-2. Other endpoints          will be interobserver variation, as measured by 1) percent volume overlap; 2) difference          in standard deviation of the average PTV-1 and PTV-2; 3) center of mass assay.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Patients will only be included after written informed consent. The preoperative     CE-CT-thorax-scan yields little additional radiation exposure, which will however be     negligible compared to the radiation treatment to be given because of the breast cancer. In     addition, there is a small risk on an allergic reaction to the intravenous contrast, and on     renal complications. Therefore, renal function will be checked prior to giving contrast. A     kreatinine clearance < 60 ml/min will be a contra-indication for contrast. The pre-operative     CT-scan will be made in MAASTRO clinic, requiring an additional visit to MAASTRO clinic. A     possible benefit may be that the pre-operative CE-CT thorax may improve the definition of the     target volume, and thereby reduce the risk on a local recurrence.   "
221258|NCT00749125|"     This study will examine activation of a brain circuit that regulates emotion in depressed     patients before and after treatment to see which areas of the brain are involved in chronic     depression.   "
219347|NCT00721071|"     The objective of the study is to evaluate the clinical utility and the feasibility, in an     outpatient setting, of sputum induction using hypertonic saline. This study will also study     pilot techniques on a sub using a sub-sample to assess the lower airway inflammatory cells     and markers in relation to new emerging organisms in cystic fibrosis (CF) and antibiotic     therapy in CF.   "
219348|NCT00721084|"     Currently, it is not known if the amount of nighttime sleep has any effect on the overall     physical fitness, and on how much energy do people who have a relative with type 2 diabetes     (parent, sibling, or grandparent) use to perform activities of daily living. This study will     test the hypothesis that individual differences in nighttime sleep duration are related to     differences in the amount of energy used to perform activities of daily living and the     overall level of physical fitness of the individual.   "
219349|NCT00721097|"     Asthma is a chronic inflammatory disease, affecting up to 10 % of the general population in     developed countries. Corticosteroids are necessary to control symptoms, but induce adverse     events sometimes intolerable. In severe asthma, which represent 5 to 10% of global asthma,     corticosteroids frequently fail to prevent severe exacerbations, leading to emergency care,     hospitalization and sometimes death. The aim of this study is to identify predictive factors     specific for exacerbation outcome which will lead to a minor increase in treatment in order     to prevent exacerbations, while minimizing drug adverse effects.   "
219350|NCT00721110|"     This study is being done to determine if combined infusions of lidocaine and ketamine is     better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after     abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations     will be done through walking tests, pain and fatigue questionnaires and blood tests.   "
219351|NCT00721123|"     This open-label, international multi-center extension study WA18695 was designed to assess     the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid     arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in     the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to     treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.   "
219384|NCT00722878|"     Primary ciliary dyskinesia (PCD), also known as Kartagener syndrome, is a genetic disorder of     the cilia, which are microscopic hair-like cells. Cilia work to keep the respiratory system     clean by moving mucus that contains debris to the large airways, where it can be coughed out.     People with PCD have cilia that do not move properly and therefore are not effective in     cleaning the respiratory system. This study will determine when PCD starts and how it changes     over time, specifically in terms of how well the lungs work, what germs grow in lung     secretions, and how the lungs look on computed tomography (CT) scans.   "
219352|NCT00721136|"     Patients requiring long term anticoagulation often undergo transition of their warfarin to     heparin in anticipation of invasive surgical procedures such as pacemaker or ICD     implantation. This may require inpatient hospitalization several days prior to and after the     procedure, potentially increasing medical costs and patient inconvenience. Patients     undergoing such a process are initiated on heparin while their INRs drift to normal levels.     Immediately prior to surgery, heparin is discontinued and restarted several hours after the     procedure. Unfortunately, this process has resulted in a high incidence of surgical wound     hematomas and other bleeding complications often requiring longer periods of discontinued     anticoagulation or repeat surgical exploration. Previous investigators have tried to reduce     the incidence of wound hematomas by prolonging the time from surgical wound closure to the     reinitiation of heparin. A small randomized trial demonstrated that there was no significant     difference in the incidence of wound hematomas whether heparin was started 6 hours or 24     hours after surgery (J Am Coll Cardiology 2000;35:1915-8). This has led many investigators to     perform pacemaker and ICD implantation without reversal of warfarin therapy. A recent     retrospective observational study demonstrated that the incidence of wound hematomas in     patients with an INR of 2.6 was no different than patients with an INR of 1.5 (PACE     2004;27:358-60). Furthermore, a more recent, larger retrospective observational study     reported in abstract form at the recent Heart Rhythm Society Annual 2007 Scientific Meeting     demonstrated that not only is performing pacemaker and ICD implantations safe without     reversing warfarin anticoagulation, but the incidence of wound hematomas is significantly     smaller as compared to the strategy of reversing warfarin and initiating periprocedural     heparin.      Given these findings, the hypothesis of this randomized study is that pacemaker and ICD     implantation while fully anticoagulated on warfarin therapy is safe. Findings from this study     will have significant implications on the clinical practice of pacemaker or ICD implantation     in this patient population given that no randomized study on this subject has been performed     to date.   "
219353|NCT00721149|"     This trial evaluates the safety and effectiveness of catheter ablation for PAF. The     investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.     At the time of this study, the NAVISTAR® THERMOCOOL® Catheter was FDA-approved for commercial     distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory     monomorphic sustained ventricular tachycardia post myocardial infarction. The catheter was     approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.   "
219354|NCT00721162|"     The purpose of this study is to determine if ramucirumab given as monotherapy is effective in     the treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary     Peritoneal Carcinoma.   "
219355|NCT00721175|"     The purpose of this study is to compare the adequacy of unilateral endoscopic biliary     drainage using metallic stent with plastic stent in unresectable, complex, hilar,     cholangiocarcinoma and cost analysis.   "
219356|NCT00721188|"     The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron     Sucrose Injection) in NDD-CKD pediatric patients.   "
219357|NCT00721201|"     The purpose of this study is to assess the effects of reducing the activity of endogenous     glucocorticoid in patients with low-grade cortisol excess   "
219358|NCT00721214|"     The purpose of this study is to examine the feasibility and efficacy of using the     demethylating agent 5-Azacytidine prior to allogeneic stem cell transplantation in patients     with high risk myelodysplastic syndrome (MDS).   "
219359|NCT00721227|"     This trial will assess the feasibility of reduction gastroplasty with standard suture in     bariatric patients who are candidates for surgical weight loss intervention.   "
219360|NCT00722553|"     The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and     folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study     will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this     patient population. Additionally, this study includes the collection of blood samples to     investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the     activity of a drug in the body over a period of time, including how the drug is absorbed,     distributed in the body, localized in the tissues, and excreted from the body).   "
219361|NCT00722566|"     Randomized, open-label, international, multi-center, Phase 3 study in which patients are     randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.   "
219362|NCT00722579|"     The PRESILLION Study is a non-randomized, multi-center, single-arm study evaluating the     safety of an approved Cobalt Chromium bare metal stent system for the treatment of ischemic     heart disease attributable to a stenotic de novo lesion in a native coronary artery.      The study population will include 100 patients with up to two de novo native coronary artery     lesions with a maximum lesion length of 30mm in a maximum of two major coronary arteries with     reference vessel diameter >= 2.5mm and <= 4.0mm by visual estimation. Patients will be     followed for 1 month and 6 month post-procedure for assessment of MACE and all other adverse     events.   "
219363|NCT00722592|"     The objective of this study is to compare progression-free survival (PFS), based upon     investigator assessment using Response Evaluation Criteria In Solid Tumors version 1.0     (RECIST 1.0) and clinical findings, in participants with platinum-resistant ovarian cancer     who receive combination therapy with vintafolide and pegylated liposomal doxorubicin     (PLD/Doxil®/Caelyx®) with that in subjects with platinum-resistant ovarian cancer who receive     PLD alone.   "
219364|NCT00722605|"     The purpose of this study is to use cone-beam CT scans to more accurately position the tumor     during radiation and to see whether this method is more effective than the standard method of     using 2D images (portal images), which is a type of X-ray. Cone-beam CT is a type of CT     scanner attached to the treatment accelerator that produces 3D images of the patient.      The ability to eliminate the tumor with radiation depends in part on the accuracy of     delivering the radiation to the lung. The position of the tumor changes because of normal     breathing. Therefore, we want to improve the accuracy of the way the radiation is delivered     to the tumor. With cone-beam CT scans taken before and during your treatment, we will be able     to determine the location of the tumor with 3D images, measure how much the tumor moves as     you breathe, and then position you so that the tumor will get the best delivery of radiation.   "
219365|NCT00722618|"     The primary objective of this trial is to determine whether written educational materials     plus brief education by telephone will help patients better understand and participate in the     decision on how many embryos to transfer to the uterus during treatment of infertility with     in vitro fertilization (IVF). The main study hypothesis is that women and men who receive the     study's educational intervention will experience favorable changes in knowledge and beliefs     about benefits, susceptibility and severity of multiple gestation that impact decisions about     the number of embryos to transfer. Secondary objectives are to understand patient beliefs,     knowledge and information preferences regarding other possible risks of IVF, to compare     perception of IVF-related risks to familiar risks that are included in routine preconception     health promotion, and during IVF, and to prepare couples to manage IVF-related obstetrical     risks when they make the transition to prenatal care after becoming pregnant.      Medical Treatment Coverage: None, this study does not provide any monetary contribution to     medical treatment   "
219367|NCT00722644|"     The primary purpose of this 5-year study is to determine whether a Cognitive Behavioral     Stress Management (CBSM) intervention, demonstrated to be effective in reducing distress,     enhancing coping, and maintaining health among HIV+ non-drug abusers (see Schneiderman and     Antoni, 2000), can be effectively adapted for our target population of culturally diverse,     HIV+, low-income Recovering Drug Abusers (RDAs). Since the late 1980s, members of our     research team (i.e., Schneiderman, Antoni, Klimas, Fletcher) have been developing, refining     and evaluating the effects of CBSM among HIV+ Men who have Sex with Men (MSM). In the     early/mid 90s, we began to adapt and evaluate the effects of CBSM in other non-drug abusing     subgroups that were emerging with increasing levels of HIV seroprevalence (e.g., pregnant     women, African American and Hispanic men and women). After accumulating considerable support     for the effectiveness of CBSM in these subgroups in the late 90s, our research team (i.e.,     Malow, Schneiderman, Antoni, Klimas, Page) turned its attention to developing the CBSM for     one of the most neglected and understudied populations affected by the HIV/AIDS epidemic in     this country: inner city minority drug abusers. With supplemental funding on two NIH grants     to conduct formative stage1 pilot research, our project team has been able to develop and     document the feasibility and potential promise of the CBSM approach adapted/translated for     RDAs (CBSM-RDA). This application proposes to take the next logical step in continuing this     work: conducting a 3, 6, 8, 10, and 12 month follow-up outcome study comparing CBSM-RDA with     a matched attention, time and interest value Health Promotion Comparison (HPC) condition, in     225 male and 225 female HIV+ RDAs with respect to key biopsychosocial health endpoints:     distress (i.e., depressive symptoms, and mood state), quality of life, drug abuse relapse,     unsafe sex, Combination Antiretroviral Therapy (CART) medication adherence and health status     indicators (e.g., Viral Load, CD4 count, physical symptoms).   "
219368|NCT00722657|"     This study had a descriptive, retrospective, transversal character with quantitative     approach, which aimed to delineate the social-economics profile of the asthmatic patients     that used the health service available at the Care Nucleon Medical Integrate (NAMI)   "
219369|NCT00722670|"     We will iteratively adapt and modify the NC woman-focused intervention (Women's CoOp),     including the field manual and instrumentation, to focus on pregnant African-American women     who abuse crack, are currently in substance abuse treatment, and are at risk for HIV or are     HIV positive. We then will test the newly developed intervention in a Stage IB pilot-sized     randomized clinical trial (RCT) in a traditional substance abuse treatment clinic to     determine (a) feasibility; (b) relative efficacy compared with substance abuse     treatment-as-usual (TAU), across several domains of functioning (e.g., substance use, HIV     risk behaviors); and (c) the intervention's potential mechanisms of action.      The specific aims of this Stage IA/B study are as follows:      Aim 1. To adapt the culturally specific, manualized woman-focused intervention to     specifically address issues of pregnancy and substance abuse, relationships with men, social     support, parenting, HIV status, living with HIV, antiretroviral (ARV) treatment, and HIV     risk-reduction methods for pregnant and postpartum women.      Aim 2. To compare the relative efficacy of the woman-focused intervention for pregnant women     relative to standard substance abuse treatment to sustain reductions in substance abuse and     sexual risk behaviors, maintain retention in drug treatment, reduce violence, and improve     prenatal care and ARV treatment adherence (as needed) at 3- and 6-month follow-up.      Aim 3. To explore the intervention's potential mechanisms of action (e.g., by examining the     mediating effects of changes in knowledge about HIV risk behaviors, psychological distress,     readiness for change) and moderating factors (e.g., HIV status, age, stage of pregnancy,     relationships with men) that may influence response to the treatment.   "
219370|NCT00722683|"     The purpose of this study is to determine if performing ultrasound with an attachment made up     of two transducers will give us more information about the blood vessels in the breast than     the current attachment that has only one transducer and to decide if using an ultrasound     agent which enhances the ultrasound signal will help see smaller blood vessels than can be     seen without the agent.   "
219456|NCT00723853|"     The purpose of this research study is to evaluate two nutrition and exercise programs in     children ages 9-12 who are at risk for developing type 2 diabetes. This study also includes     the involvement of parents or guardians who are willing to participate in these programs with     the child.   "
219371|NCT00722696|"     The purpose of this study is to evaluate metabolic parameters in previously sedentary     individuals before and after eccentric endurance training (hiking downwards). Study     participants will regularly hike downwards over a difference in altitude of 540 meters during     8 weeks. For the opposite way, a cable car will be used. Metabolic profiles will be obtained     at baseline and after the 8 weeks period of eccentric endurance exercise.   "
219372|NCT00722709|"     Aim:      The general aim of this research group is to improve the recovery of patients after abdominal     surgery. The specific aim of this study is to conduct a randomized, double blinded,     controlled trial to investigate the effect of intra-peritoneal local anaesthesia application     on postoperative pain and post-operative fatigue. This will be conducted in the setting of an     enhanced recovery after surgery program (ERAS).      Methods:      Patients will be randomised by computer generated random numbers and opaque envelope method.     In the treatment arm patients will receive 10ml 0.75% ropivacaine diluted to 50mls with 0.9%     saline soon after the creation of the laparotomy . In the placebo arm, 50mls of 0.9% normal     saline will be used in a similar fashion. At closure, two small 2mm catheter belonging to the     On-Q pain buster system will be placed in the peritoneal cavity. This will be attached to a     pump which will contain either a 0.2% ropivacaine solution or 0.9% saline placebo running at     4mls/hr for 68 hours. All members involved in patient care (with the exception of one nurse)     will be blinded to the above. After 68 hours the pump will be stopped and the catheter will     be removed. Assessment of postoperative pain will be performed by visual analogue scale, and     fatigue assessment will be done using the Identity Consequence Fatigue Scale (ICFS) at     various intervals post-operatively. Blood tests for inflammatory markers including glucose,     cortisol, CRP, albumin and several cytokines as well as local anaesthetic levels will be     taken.      Significance to health:      This method of analgesia administration has not been investigated in open major colonic     surgery. This trial has wide reaching implications, with the potential to improve pain and     thus recovery after abdominal surgery.   "
219373|NCT00722722|"     Patients planning to have kidney transplantation who are sensitized to their donors have high     levels of donor specific alloantibodies. High levels of donor specific antibodies put kidney     transplant recipients at risk for rejection very early after transplant. This study is trying     to determine if the drug bortezomib (Velcade ™) can reduce donor specific alloantibodies to a     level that permits kidney transplantation without a high risk for rejection.   "
219374|NCT00722735|"     To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female     patients with uUTI.   "
219385|NCT00722891|"     This study will investigate the ocular response to lens wear in 30 subjects.   "
219376|NCT00722761|"     The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and     effective for treating acne on the trunk (the main part of the body that does not include the     arms, legs, and head).      Acne vulgaris is a very common skin disorder. It is caused when oil-producing skin glands     (sebaceous glands) become plugged. The plug can cause blackheads, whiteheads, pimples, and     cysts on the face, neck, upper chest, and upper back.      YAZ is a combination birth control pill. A combination pill means that it is made up of     more than one major ingredient. Nearly all birth control pills are made up of a combination     of estrogen and progestin hormones. Estrogens are steroid hormones produced by the ovaries     responsible for the typical female features. Progestins are steroid hormones produced by the     ovary and placenta responsible for making the uterus fit for pregnancy. YAZ also contains an     estrogen called ethinyl estradiol, and a progestin called drospirenone. People who develop     acne have sebaceous glands that are over-stimulated (that is, the sebaceous glands have     increased activity) by male sex hormones (androgens). The progestin in YAZ blocks the male     sex hormones (androgens) that cause acne.      The study drug being used in this study is called YAZ. It has been approved by the U.S. Food     and Drug Administration (FDA) to treat moderate acne in women who want an oral contraceptive     for birth control.      In this study, YAZ will be compared to a placebo for safety and effectiveness. A placebo     looks like the study drug but contains no active drug (like a sugar pill). We use placebos in     research studies to learn if the effects seen in research subjects are truly from the study     drug or from other reasons.   "
219377|NCT00722774|"     In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were     associated with significant morbidity and mortality. It is estimated that, in the United     States alone, the next influenza pandemic could cause approximately 200,000 deaths and     750,000 hospitalizations. Thus, the development of a vaccine against potential influenza     strains has become a priority. The purpose of this study is to determine the safety and     immune response to an H2N2 influenza vaccine candidate.   "
219378|NCT00722800|"     The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and     effective for treating hidradenitis suppurativa. Hidradenitis suppurativa (HS) is a chronic     (long lasting) skin disorder that mostly affects the armpits and groin area. It appears as     blackheads and one or more red, tender bumps that may enlarge, break open, and drain pus.     Scarring may result after several attacks of the disease.      The exact cause of HS isn't known. However, it is believed that the plugging of hair     follicles and bacterial infection that occur in acne also occur in HS. Many of the     medications used for treating acne are also used for HS. However, none of the medications are     consistently effective.      YAZ is a combination birth control pill. Nearly all birth control pills are made up of a     combination of estrogen and progestin hormones. YAZ contains ethinyl estradiol (an estrogen)     and drospirenone (a progestin). People who develop acne have sebaceous glands that are     over-stimulated by male sex hormones (androgens). Sebaceous glands secrete an oily substance     into a hair follicle to lubricate hair or skin. The progestin in YAZ actually blocks the male     sex hormones (androgens) that cause acne. Hormones seem to play a role in HS as the condition     occurs after puberty. It affects more women than men and HS often gets worse around the time     a women has her menstrual period.      YAZ has been approved by the U.S. Food and Drug Administration (FDA) to treat moderate acne     in women who desire an oral contraceptive for birth control.      This study uses a placebo. A placebo looks like the study drug but contains no active drug.     We use placebos in research studies to learn if the effects seen in research subjects are     truly from the study drug or from other reasons.   "
219380|NCT00722826|"     Patients with pulmonary regurgitation after surgical correction of ToF over 13 years old will     be recruited from the UCSF adult congenital heart disease clinic. Since there is no data in     the literature describing the prevalence of abnormal MRI volumetric and functional parameters     in asymptomatic patients with PR after ToF repair, a pilot study with 30 patients will be     conducted. Increase in sample size may be necessary in the future to accurately interpret the     data. After informed consent is obtained, clinical history and physical examination as well     as review of old charts will be performed to characterize these patient's clinical status.     All patients will undertake a graduated supine bicycle exercise test with MVO2 measurement to     assess exercise capacity.      MRI studies will be performed in a 1.5 tesla unit. SSFP cine images will be obtained in the     short-axis plane encompassing the entire heart. Velocity-encoded cine MR images will be     obtained perpendicular to the direction of blood flow in the main pulmonary artery.     Volumetric and flow analysis will be performed in a separate dedicated workstation by a     radiologist. End-diastolic volume, end-systolic volume, ejection fraction, total ejection     fraction and pulmonary regurgitant fraction will be calculated.   "
219381|NCT00722839|"     RATIONALE: Vaccines made from peptides may help the body build an immune response to kill     cytomegalovirus.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     preventing cytomegalovirus in healthy participants.   "
219382|NCT00722852|"     The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg     ketoprofen in Diractin®.   "
219383|NCT00722865|"     The purpose of this research study is to determine the effectiveness and safety of Avastin     when combined with standard chemotherapy for Hodgkin lymphoma. Avastin works differently than     standard chemotherapy drugs. It is a type of protein called an antibody which binds to a     substance called VEGF(Vascular Endothelial Growth Factor). VEGF stimulates the growth of the     blood vessels that feed tumors and encourages tumor cell growth. VEGF is produced in excess     by Hodgkin lymphoma cells, and is associated with a poorer outcome in patients with Hodgkin     lymphoma. When the activity of VEGF is interrupted in multiple other cancer types, the blood     vessels around the tumor cells die resulting in less nutrient delivery and death to the     tumor. Blocking of VEGF has also been shown to improve delivery of chemotherapy to cancer     cells, making standard chemotherapy work better. This trial uses Avastin in combination with     standard chemotherapy with the goal of improving the cure rate over chemotherapy alone.   "
219401|NCT00723112|"     The purpose of the study is to elucidate the causative molecular events responsible for the     abnormal erythropoiesis in MDS.   "
219466|NCT00723983|"     To compare the pharmacokinetics of NP101 with a currently approved oral formulation of     Imitrex® (50 mg) in migraine subjects both during an acute migraine attack and during a     non-migraine period.   "
219386|NCT00722904|"     Aortic coarctation is a relatively common cardiovascular condition with high associated     mortality if not treated. Even with successful repair, however, close follow up is needed as     late complications can result in significant cardiovascular morbidity. MRI, with is ability     to provide both anatomic and hemodynamic information, is becoming the imaging option of     choice for post-intervention surveillance. Time-resolved, three-dimensional phase contrast     magnetic resonance velocity (4D Flow) profiling enables the acquisition of multidirectional     blood velocity data. The technique is well suited for evaluation of blood flow patterns in     the thoracic aorta. By comparing aortic flow patterns in patients status post coarctation     repair with those of healthy volunteers using 4D Flow, this study intends to characterize     abnormal flow patterns in these patients with the eventual goal of better understanding and     predicting late complications so that preemptive intervention may be taken.      Given the potential use of 4D Flow for evaluation of other types of vascular pathology in the     aorta and other vascular regions, we hope to investigate the use of the technique on a     limited basis for a broader population of adult patients. Other research groups have had     success evaluating peripheral stenoses, as well as intracardiac and intracranial blood flow     patterns with 4D Flow.   "
219387|NCT00722917|"     The purpose of this study is to evaluate the safety and effectiveness of multiple doses of     TAK-379, once daily (QD), in subjects with type 2 diabetes mellitus.   "
219388|NCT00722930|"     To evaluate the complete clinical response rate according to the International Working Group     criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients     with high-risk follicular lymphoma with either partial or complete response to R-CHOP     induction chemotherapy   "
219389|NCT00722943|"     The purpose of this study is to see if daily massage therapy will help premature infants     respond to stress better, as well as improve their growth and neurobehavioral development.   "
219390|NCT00722956|"     The purpose of the study is to assess the pharmacokinetics of both AZD5672 (steady-state) and     atorvastatin (single dose) when co administered in healthy volunteers   "
219391|NCT00722969|"     Patients with advanced or metastatic (stage IIIB-IV) non small cell lung cancer who have not     received prior chemotherapy will be treated with erlotinib 150 mg once a day and sorafenib     400 mg twice a day. The objectives of the study are to assess the efficacy and safety of this     combination treatment. Additional exploratory study objectives are correlation of biomarkers     and imaging modalities potentially predictive for response and (progression free) survival.   "
219392|NCT00722982|"     Hypothesis: Migration of C-Stem AMT is equal to the well documented Exeter prosthesis      In Norway it is annually performed approximately 600 primary and 100 revisions THA.     Osteolysis around the prosthesis is one of the major difficulties while performing revision     surgery. C-stem is a triple tapered cemented prosthesis designed to increase the stress and     strain of proximal femur and thereby decreasing osteolysis. We are planning til include 70     patients and randomize to C-stem AMT or Exeter prosthesis. Both prosthesis will be combined     with previously non documented Marathon acetabular prosthesis.      The result will be followed clinically and with RSA and DXA. Soft endpoint after 2 years   "
219393|NCT00722995|"     The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit     than the gastric bypass   "
219396|NCT00723047|"     This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude     Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the     efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients     with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège,     Belgium approved the protocol for each participating centers. Recruitment took place at 12     sites (11 in France and 1 in Belgium)   "
219397|NCT00723060|"     OBJECTIVE: The objective of this study is to compare the effect and safety of conventional     dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive     disorder (OCD).      OVERVIEW OF STUDY DESIGN: Prospective, Randomized, Active-controlled, Double-blind,     Multi-center, Clinical Trials STUDY POPULATION: Patients with OCD EFFICACY EVALUATIONS:     Y-BOCS (D-YBOCS), HAM-D, HAM-A, CGI-S & -I, GAF, OCI-R SAFETY EVALUATION: Adverse Events /     Serious Adverse Events, UKU   "
219398|NCT00723073|"     Invasive fungal infections are an important cause of morbidity and mortality in patients with     neutropenia who are receiving chemotherapy for cancer. Early diagnosis of these infections is     difficult and fever may be the only sign. A delay in treatment while a diagnosis is pursued     may lead to increased morbidity and mortality. There are now several echinocandins available     with similar in vitro spectrum of activity. Caspofungin is the only echinocandin Food and     Drug Administration (FDA) approved for empiric antifungal therapy in febrile neutropenia.     Although all echinocandin antifungal agents have similar spectrum of activity, there are     limited data on the use of micafungin in patients with persistent fever and neutropenia (FN).     In November 2006 the Pharmacy and Therapeutics Committee at Brigham & Women's Hospital / Dana     Farber Cancer Institute (BWH/DFCI) switched from caspofungin to micafungin as our formulary     echinocandin. Given the limited clinical data on the use of micafungin as empiric antifungal     therapy in patients with FN, we sought to evaluate the safety and effectiveness of     micafungin, compared with caspofungin, for this indication using a sequential cohort analysis     of patients treated before and after the formulary change at Brigham and Women's Hospital.   "
219399|NCT00723086|"     The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks     repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic     hormone refractory prostate cancer.   "
219400|NCT00723099|"     This phase II trial is studying how well umbilical cord blood transplant from a donor works     in treating patients with hematological cancer. Giving chemotherapy and total-body     irradiation (TBI) before a donor umbilical cord blood transplant helps stop the growth of     cancer and abnormal cells and helps stop the patient's immune system from rejecting the     donor's stem cells. When the healthy stem cells from an unrelated donor, that do not exactly     match the patient's blood, are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells     (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil before and     after transplant may stop this from happening.   "
219402|NCT00723125|"     In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus     Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in     HER2(-) patients was 20%. The investigators' goal is to develop an induction chemotherapy     regimen that will have a pCR rate above 30% in patients with HER2(-) disease. Based on a     1-sided 95% confidence interval using normal approximation with an expected pCR rate of at     least 35%, approximately 28 patients are required for each cohort. With an assumed pCR rate     of at least 35%, the investigators will have approximately 70% statistical power to conclude,     with 90% certainty, that the pCR rate with the novel regimen exceeds 20%. The study will     accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed     10%.   "
219403|NCT00723151|"     The purpose of the study is to determine if a more intensive application of communication     intervention, i.e. 5 hours per week, will result in more frequent intentional communication     acts, greater lexical density, and a better verbal comprehension level than children who     receive the same communication intervention only one time per week.   "
219404|NCT00723164|"     The goal of this study was to investigate the effects of fentanyl-midazolam premedication     during sevoflurane induction pertaining to time to loss of eyelash reflex (LER), time and     conditions of insertion of proseal laryngeal mask airway (PLMA), as well as     cardio-respiratory data. Participants' anxiety level was also evaluated.   "
219405|NCT00723177|"     Repeated use and/or abuse of opioid medications is generally associated with a characteristic     withdrawal syndrome that develops after cessation of drug administration. The present study     is designed to evaluate the effectiveness of AV411 to alter opioid-induced withdrawal     symptoms.   "
219406|NCT00723190|"     The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of     CLONICEL (clonidine HCl sustained release) when administered chronically under regular     clinical conditions either as monotherapy or in combination with stimulant therapy to     children and adolescents with attention deficit hyperactivity disorder (ADHD).   "
219407|NCT00723203|"     RATIONALE: Panobinostat may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying the side effects of panobinostat and to see how well     it works in treating patients with relapsed or refractory acute lymphoblastic leukemia or     acute myeloid leukemia.   "
219408|NCT00723216|"     The primary objective of this study is to evaluate the effects of enoxaparin on venous     thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing     curative abdominal cancer surgery. The secondary objective is evaluate the incidence of     adverse events of enoxaparin in these patients.   "
219409|NCT00723229|"     We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in     patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID)     for HSV-2 suppression compared to taking no medication to better define the effect of     acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized,     open label, cross-over trial. We hypothesize that short bursts of HSV-2 reactivation will not     be suppressed by acyclovir.   "
219410|NCT00723242|"     The role of the dendritic cells, the most potent antigen presenting cells, in the     establishment of chronic hepatitis C is not established. The study aims to define whether the     dendritic cells are affected by the hepatitis C virus and whether that bears an impact on the     antiviral immune response they generate. The hypothesis is explored by investigating a group     of patients prior to and after the initiation of standard treatment for hepatitis C with     pegylated Interferon and Ribavirin.   "
219411|NCT00723255|"     This phase II trial is studying the side effects of giving bevacizumab together with     temsirolimus and to see how well it works in treating patients with recurrent or persistent     endometrial cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the     growth of tumor cells by blocking some of the enzymes needed for their growth. Giving     bevacizumab together with temsirolimus may kill more tumor cells.   "
219412|NCT00723268|"     The purpose of this study is to determine whether low doses of prednisolone, or colchicine     are effective in the treatment of oral aphthae.   "
219413|NCT00723281|"     The overall goal of this study is to determine if non-invasive imaging with state of the art     CT coronary angiography can be used to screen for transplant coronary artery disease in the     setting of heart transplant.      Our current protocol at UCSF for heart transplant patients involves screening with stress     tests as well as coronary angiograms with intravascular ultrasound to assess the diameter of     the lumen of the coronary arteries and to assess wall thickness.   "
219414|NCT00723294|"     This phase II trial is studying how well cryoablation therapy works in treating patients with     invasive ductal breast cancer. Cryoablation kills tumor cells by freezing them. This may be     an effective treatment for patients with invasive ductal breast cancer.   "
219415|NCT00723307|"     Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary     heart disease and on standard cardiovascular risk reducing agents including statins will have     a beneficial impact on carotid artery atherosclerosis compared to placebo.      Rationale: Once subjects have a heart attack, they remain at much higher than average risk of     another heart attack and stroke, despite the best current therapies to lower their     cholesterol and blood pressure and thin their blood. Many subjects with heart disease also     have problems metabolising (i.e. processing) sugar even if they do not have diabetes. There     is some evidence that metformin, a drug which improves sugar metabolism, decreases the risk     of future heart attacks in diabetic patients. However, whether metformin further reduces the     risk of heart disease beyond established treatments in people without diabetes is unknown.      Method: The investigators will test the ability metformin, a drug with proven safety, to slow     the progression of furring up (known as atherosclerosis) of blood vessels in non-diabetic     subjects with heart disease. This will be achieved by treating 2 groups of subjects with     metformin and placebo pills respectively. To measure atherosclerosis, the investigators will     carry out ultrasound scans of the big blood vessels in the neck at the start of the study,     after 1 year and after 1.5 years of therapy.The investigators will then be able to assess     whether metformin has had a beneficial impact.   "
219418|NCT00723346|"     Primary objective :        -  To explore the relation between 3 doses of GRASPA and duration of asparagine depletion          (< 2µmol/l)      Secondary objective :        -  Pharmacokinetic / Pharmacodynamic parameters        -  toxicity        -  Study duration : 2 years        -  Study treatment : Red blood cells loaded with L asparaginase versus native L          asparaginase        -  Associated treatments : COPRALL chemotherapy        -  Randomization : centralised randomisation on scratching list   "
219419|NCT00723359|"     This Phase I research study is to test the effects (good and bad) and best dose of BT062 in     treating patients with relapsed or refractory multiple myeloma.   "
219420|NCT00723385|"     The purpose of this study is to examine whether oral vitamin D supplementation in people with     inadequate vitamin D concentrations will lower LDL-cholesterol and total cholesterol     concentrations.   "
219421|NCT00723398|"     The overall hypothesis is that the combination of a low dose of the antiestrogen Raloxifene     with omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect due to     the crosstalk of their downstream cellular effects leading to decreased proliferation and     increased apoptosis of premalignant mammary cells. Based on the investigators hypothesis that     upregulation of functional estrogen receptors in the premalignant lesions is also responsible     for the development of hormone independent tumors, the investigators postulate that the     combination of antiestrogens and omega-3 fatty acids will reduce the development of both     hormone-dependent and -independent tumors. At present, there are no known interventions able     to decrease the development of hormone-independent tumors, which are more prevalent, more     aggressive, leading to the patient's demise. In addition, the investigators postulate that     this approach will be safe since it will combine a lower and hence a less toxic dose of     Raloxifene with the administration of omega-3 fatty acids which are known to have health     benefits, i.e., reduction in cardiovascular risk, beyond their possible chemo preventive     effect in breast cancer.   "
219422|NCT00723411|"     The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is     effective in preserving the body's own insulin producing capacity in patients recently     diagnosed with type 1 diabetes.   "
219423|NCT00723424|"     The purpose of the study is to examine the effect of AZD5672 (dosed to steady state) on the     pharmacokinetics of digoxin (single dose administration).   "
219487|NCT00724256|"     The purpose of this study is to evaluate the efficacy of oral ceftibuten for 7 days versus 10     days in acute pyelonephritis in children.      The main hypothesis is that the ceftibuten for 7 days will be not inferior to ceftibuten 10     days in the rate of renal scarring at 6-12 months.   "
219424|NCT00723437|"     Objective:      Efficacy of systemic retinoid therapy of nail psoriasis has never been assessed objectively.     Evaluate therapeutic efficacy of acitretin in patients with isolated nail psoriasis.      Design:      Open-study on thirty-six patients with moderate to severe nail psoriasis treated with     acitretin.      Participants:      Patients included 27 men and 9 women (mean age 41) with nail psoriasis. Intervention: Therapy     consisted of acitretin 0.2 to 0.3 mg/Kg/day for 6 months.      Main Outcome Measure(s):      Clinical evaluation, NAPSI and modified NAPSI scores before therapy, every 2 months during     therapy and 6 months after treatment.   "
219425|NCT00723450|"     The study will be a multi-center, parallel, group, placebo control, double-blind, randomized     controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged     10 to 17 years) diagnosed with Bipolar I disorder. The study consists of 4 phases: Screen     (approximately 2 weeks), Open label phase (up to 18 weeks), Randomized phase (up to 36 weeks)     and Taper and follow-up phase (up to 4 weeks).   "
219426|NCT00723463|"     The purpose of this study is to determine normal measurements (ADC values) from the head and     neck of healthy volunteers using 3T MRI.   "
219427|NCT00723476|"     This study will examine the efficacy of Family Centered Advance Care Planning in enhancing     quality of life, integrating effective end-of-life care, and preventing depression and     anxiety among HIV infected adolescents and their family members.   "
219428|NCT00723489|"     The main objective of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) is to     reduce the risk of the fatal reaction, eczema vaccinatum (EV), to the smallpox vaccination in     those with atopic dermatitis (AD). Since vaccination with live vaccinia virus (VV) in     individuals with AD increases the risk of EV, a yellow fever vaccine was chosen. The purpose     of this study is to determine the immune response to a yellow fever vaccine in adults with     AD.   "
219429|NCT00723502|"     The primary objective of this study is to compare the H. pylori eradication rates with     Finafloxacin in combination with Amoxicillin or Esomeprazole.      The secondary objective is to evaluate and compare the safety and tolerability of multiple     oral doses of Finafloxacin plus Amoxicillin versus Finafloxacin plus Esomeprazole.   "
219430|NCT00723515|"     The study hypothesis is the difference in therapeutic effect of two varnish formulations (G1     = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2). These products are commercially available in the     Brazilian and international market and they are used for dental caries as white spot lesions     control.   "
219431|NCT00723528|"     The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275)     compared with placebo in participants with moderate to severe plaque type psoriasis.   "
219432|NCT00723541|"     The purpose of this study is to develop a computer-aided diagnosis system to find breast     lesions, including masses and microcalcifications, which hopefully will improve breast cancer     detection and classification.   "
219433|NCT00723554|"     A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension     Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From     Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)   "
219434|NCT00723567|"     The purpose of this study is to find a gene or its mutation (an altered gene) that puts     individuals at risk for developing HE or HPP.   "
219435|NCT00723580|"     The study examines and illustrates the utility of utilizing actigraphic measurements to     assess treatment response.   "
219467|NCT00723996|"     The overall goal of the proposed research is to explore behavioral correlations between     colorectal cancer screening and screening mammography.   "
220680|NCT00741871|"     This is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose     limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced     lymphoid malignancies.   "
219436|NCT00723593|"     This study will determine the best location to biopsy the gastrointestinal (GI) tract for     early and accurate diagnosis of GI graft-versus-host-disease (GVHD). (A biopsy is the     surgical removal of a small piece of tissue for examination under the microscope.) GVHD is a     life-threatening complication of stem cell transplantation in which the donor s immune cells     destroy the patient s healthy tissues. It most commonly affects the skin, liver and GI tract.     This study will establish where to best biopsy tissue from the GI tract and study the tissue     to try to explore how GI GVD occurs and how it may be possible to better diagnose and treat     it.      Patients 18 years of age and older who have undergone or are who will undergo stem cell     transplantation and who are at high risk for developing GI GVHD may be eligible for this     study. Participants may enter the study before the transplant procedure or later if they     develop GVHD symptoms.      Participants undergo the following tests and procedures:      I. Before starting conditioning chemotherapy or radiation therapy for the transplantation        -  Medical history and physical examination        -  Sigmoidoscopy (endoscopy of the lower part of the large intestine) and biopsies        -  Blood draw        -  Stool sample collection      II. Two to 3 weeks after conditioning regimen        -  Sigmoidoscopy with biopsies        -  Blood draw        -  Stool sample collection      III. 30, 45, 60 and 90 days after transplantation      -Blood draw      IV. After completing the tests in part II and at the appearance of GI symptoms suspected to     be due to GVHD        -  Updated medical history and physical examination        -  Esophagogastroduodenoscopy (endoscopy of the esophagus, stomach and upper small          intestine)        -  Colonoscopy (endoscopy of the entire part of the large intestine) with biopsies        -  Blood draw        -  Stool collection      V. Two weeks after starting therapy in patients diagnosed with GVHD        -  Sigmoidoscopy with biopsies        -  Blood draw        -  Stool sample collection        -  PET/CT scan in selected patients (nuclear medicine and x-ray imaging of the GI tract   "
219437|NCT00723606|"     This local registration study is to confirm the hypothesis of the efficacy, tolerability and     safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in     schizophrenia   "
219438|NCT00723619|"     Synopsis: LUNOKID-Study      Investigation of Lung function Normal Values in Children and Adolescent in Germany      For the diagnostic work-up of childhood airway diseases lungfunction measurements play an     important role. As childhood represents a period of continuous development and growth, not     only is body size and weight increasing and body composition changing with age, but also is     the lung developing both in size and airway differentiation. Results from lung function     measurements in children and adolescents have thus to be related to lung function data which     have been determined in a normal healthy age-matched childhood population. The quality of the     reference values is therefore crucial for the interpretation of lung function results.      The reference values for children that are used today have been created between around the     1970th or 1980th, although the development and body size of children in the last decades has     considerably changed and accelerated.      The aim of the LUNOKID study is to create new reference values for lung function measures in     healthy children aged 4 to 18 years. Measurements will be performed in schools and     kindergartens in 3 regions of Germany (Wesel, Düsseldorf, Hannover).      A modified ISAAC questionnaire will be distributed to the parents to get information on the     family´s and child´s health history with regard to atopy, airway diseases or other diseases     that could influence the lung function results. A clinical examination on the day of lung     function performance should exclude acute infections or other diseases. Parents will have to     give informed consent to the study.      Study personal, especially trained in the lung function unit of the University Hannover, is     going to do all examination and lung function measures during the normal school hours at the     sites of the schools and kindergartens.      The following measurements will be performed according to the respective SOPs:        -  Body weight and hight        -  Exhaled NO, using the NIOX -MINO in children from the age of 5 years onwards, in 4 years          old children using the off-line method (both Aerocrine)        -  Spirometry including Flow volume curves (Parameter FEV1, FEV0.5, FEV 0.75, PEF, FVC, MEF          25, MEF 50, MEF 75) using a Spirometer by the company ndd Medizintechnik AG, Zürich        -  Ultrasonic pneumography (UPG) (tidal breathing), ndd Medizintechnik AG, Zürich      It is planned to have 50 valid measurements per gender and age group. Considering that about     50 % of the children (and 50-75% of the 4 years´old) have to be excluded for the normal     reference analysis either for health reasons or because the lung function measurement cannot     be correctly performed. The investigators therefore calculate to included in the study around     3300 children.      All data will be gathered and managed in a central database in the IUF in Düsseldorf. The     statical analysis will include regression analyses to calculate the reference values.      It is planned to have the new reference values included in the guidelines for diagnostic and     management of asthma in childhood, and in the software of lung function equipment. By now,     the study is approved by the Ethical Committee responsible for the PI in Wesel.   "
219439|NCT00723632|"     The objective of the study is to evaluate the costs associated with peginterferon alfa-2b     (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic.     Only costs associated with rescue medication, concomitant therapy, disease monitoring, and     medical intervention costs recognized by the treating institution as treatment-related     expenses will be included in the analysis. The study will also evaluate the correlation     between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant     history.   "
219440|NCT00723645|"     This is an observational, multicenter, nationwide study where information will be collected     on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral     response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus     ribavirin (RBV) administered according to the directions on the products' labeling. No     administration of treatment is planned as a result of study enrollment.   "
219454|NCT00723827|"     The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of     Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the     following points that are in question and doubt:        -  Incidence of adverse events under actual conditions of use (Serious and Nonserious          Adverse Events);        -  Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected          Adverse Reaction);        -  Adverse Event caused by misuse, abuse, or drug interactions;        -  Other information concerned with safety or efficacy.   "
219488|NCT00724269|"     The purpose of this study is to evaluate the corneal epithelium after soft contact lens wear     and use of two marketed multi-purpose solutions.   "
219441|NCT00723658|"     RATIONALE: Sometimes the cancer may not need treatment until it progresses. In this case,     observation may be sufficient. Giving combination chemotherapy together with bortezomib,     thalidomide, and rituximab before an autologous peripheral stem cell transplant stops the     growth of cancer cells by stopping them from dividing or killing them. Giving     colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the     blood so they can be collected and stored. More chemotherapy is then given to prepare the     bone marrow for the stem cell transplant. The stem cells are then returned to the patient to     replace the blood-forming cells that were destroyed by the chemotherapy.      PURPOSE: This observational and phase II trial is studying how well giving combination     chemotherapy together with bortezomib, thalidomide, and rituximab followed by two autologous     peripheral blood stem cell transplants works in treating patients with Waldenstrom     macroglobulinemia.   "
219442|NCT00723671|"     The purpose of this study is to find out if certain types of Magnetic Resonance (MR) scanning     will help to better detect markers in the brain that are related to the neuropsychiatric     symptoms of systemic lupus erythematosus (SLE). A small percentage of patients who have this     type of lupus experience symptoms that may result from a blood clot or change in blood vessel     structure in the brain. These neuropsychiatric symptoms can include an inability to think     clearly, a change in level of awake and/or awareness, and in the worst cases, seizure and     stroke. Another goal of the study is to find out if individuals with fibromyalgia (FM), or     chronic pain, have symptom-related markers in any of these scans as well. Better and earlier     detection of markers that are related to acute neuropsychiatric lupus (NPSLE) and FM will be     helpful to all who are affected by these diseases.   "
219443|NCT00723684|"     Background:      Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to     patients with ADHD in several mostly uncontrolled studies with relatively small sample sizes.     It is unknown how EEG-neurofeedback affects brain functioning and exerts therapeutic effects     in ADHD. This study is designed to examine the efficacy and safety of EEG-neurofeedback in a     scientific rigorously way and to study the underlying neurobiological mechanisms of     EEG-neurofeedback.      Objectives:        1. To investigate the efficacy of EEG-neurofeedback in reducing behavioral symptoms of          ADHD.        2. To investigate whether EEG-neurofeedback is able to improve neurocognitive functioning.        3. To investigate whether EEG-neurofeedback is able to improve neural functioning.      Study design:      Double-blind randomized placebo-controlled treatment study.Study population: 120 subjects     with ADHD (age 8-15, IQ of 80 or more). Intervention: 60 subjects with ADHD receive 30     sessions EEG-neurofeedback, and 60 subjects with ADHD receive placebo EEG-neurofeedback.      Main study parameter: ADHD-DSM-IV rating scale, rated by the investigator.      Hypothesis:      The hypothesis is EEG-Neurofeedback can reduce symptoms of ADHD.   "
219444|NCT00723697|"     The purpose of this study is to assess the risks of abuse, misuse and adverse events related     to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or     its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this     study. Data will be collected using physician questionnaires and self evaluation patient     questionnaires at the first visit and visits at 6 and 12 months.   "
219445|NCT00723710|"     Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment     with high-dose Intron A for one year. The objective of this study is to maximize treatment     compliance by proactive management of side effects in a day-to-day healthcare setting.   "
219446|NCT00723723|"     This observational study is being conducted in patients receiving statin treatment as     secondary prevention of coronary heart disease under the current standard of care in     compliance with European guidelines. The purpose of the study is to evaluate the percentage     of these patients that reach target LDL levels. Additionally this study will measure the     patient's compliance to treatment as assessed by counting the returned tablets. Both     assessments will be made at visits conducted 6-8 weeks after the first visit and 28-32 weeks     after the first visit.   "
219447|NCT00723736|"     The objective of this non-interventional study is to evaluate the safety of Aerius syrup in     pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria.     The patients will receive 2.5 ml (1.25 mg) once daily.   "
219448|NCT00723749|"     The aim of this post marketing surveillance study is to investigate the retention rate after     12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid     dependent patients under real life conditions.   "
219449|NCT00723762|"     The purpose of this study is to investigate potential mechanisms of valproic acid-associated     low serum albumin in medically fragile pediatric and young adult epileptic patients of a     long-term care facility.   "
219450|NCT00723775|"     To compare plasma GSK706769 PK following repeat administration of GSK706769 QD with and     without KALETRA (LPV 400 mg/RTV 100mg) q12h   "
219451|NCT00723788|"     Study to find out if MRI can diagnose appendicitis in children as well as or better than CT     scan and/or ultrasound scan performed at the same time. No additional contrast material or     sedation will be used to perform the MRI.   "
219452|NCT00723801|"     Marfan syndrome is an inherited connective tissue disorder with morbidity and mortality from     aortic dilation and dissection. The degree of aortic dilation and response to beta-blockade     (standard of care) vary in adults with Marfan syndrome. However, aortic stiffness is often     present, and can be a predictor of aortic dilation and cardiovascular complications. In     addition, adults with Marfan syndrome develop left ventricular diastolic dysfunction, which     can progress to heart failure. Aortic stiffness and diastolic dysfunction are important and     logical therapeutic targets in adults with Marfan syndrome.      TGF-beta mediates disease pathogenesis in Marfan syndrome and contributes to aortic     stiffness. The angiotensin receptor blocker, losartan, inhibits TGF-beta activity and     reverses aortic wall pathology in a Marfan mouse model. Losartan also decreases aortic     stiffness and improves diastolic function in hypertension, renal disease and hypertrophic     cardiomyopathy.      This trial is a randomized, double-blind trial of 50 adults with Marfan syndrome, treated     with 6 months of atenolol vs. losartan. Arterial tonometry for aortic stiffness and     echocardiography for diastolic function will be performed at the beginning and end of     treatment. A blood draw for serum markers of extracellular matrix turnover and inflammation     will also be performed at 0 and 6 months. We plan to determine whether losartan decreases     aortic stiffness and left ventricular diastolic dysfunction significantly more than atenolol.   "
219457|NCT00723866|"     Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy     (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined     application of the two modalities has rarely been studied. The aim was to investigate whether     combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity     function than BtxA plus conventional rehabilitation in chronic stroke patients with upper     extremity spasticity.   "
219458|NCT00723879|"     Patients receiving a patient assistance program during therapy for Hepatitis C will be     enrolled into this study. All patients will receive PegIntron and Rebetol (according to the     label) and the patient assistance program, which includes (1) medications used for treatment     (psychiatric medications); (2) other interventions (nurse support); and (3) educational     literature. This study will be compared to similar studies from other clinics using various     patient support programs for the purpose of designing future comparative phase IV studies.   "
219459|NCT00723892|"     Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles,     anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur     during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue     their treatment early. The goal of this study is to assess whether a psychotherapy support     program may contribute to a better adherence rate.   "
219460|NCT00723905|"     Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year,     starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade     Infusion Network (R.I.N.) will participate. This registry will be a multicentre, prospective,     observational program that will gather and analyze data on subjects being treated with     infliximab.   "
219461|NCT00723918|"     The purpose of this study is to evaluate the effectiveness of methadone alone and in     combination with SAB378 for the treatment of painful HIV-associated neuropathy.   "
219462|NCT00723931|"     Surveillance will be conducted at digestive departments of internal medicine in university or     general hospitals where participants with chronic hepatitis C are generally treated. The     purpose of this surveillance is to evaluate the postmarketing safety and efficacy of     PegIntron Injection under actual conditions of use and to examine adverse events, serious     adverse events, and adverse drug reactions.   "
219463|NCT00723944|"     This prospective, randomized study evaluates the performance and crestal bone changes     difference between the Osseotite Certain Prevail vs the non-lateralized design of the     implant.      Study (null) hypothesis: the crestal bone changes that take place after placement and loading     of the Osseotite lateralized implants will be the same as for similar but non-lateralized     Osseotite Certain implants.   "
219464|NCT00723957|"     The purpose of this study is to determine whether progression-free survival with ixabepilone     is superior to that achieved with paclitaxel plus carboplatin in participants with advanced     nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.   "
219465|NCT00723970|"     The study was designed to examine the efficacy and tolerability of quetiapine XR for the     treatment of women who suffer from depression in the context of the menopausal transition and     postmenopausal years. Besides the improvement of depressive symptoms, the investigators are     interested in examining the impact of this medication on vasomotor symptoms (hot flashes,     night sweats), sleep and overall quality of life.   "
219468|NCT00724009|"     For relapsed and refractory leukemia patients induction chemotherapy prior to initiating a     conditioning regimen will decrease residual leukemia (as measured by bone marrow leukemia     blast percentage) at the time of HCT. This should lead to reduced relapse while still     maintaining low transplant related mortality.   "
219469|NCT00724022|"     Current practice of immune suppressive standard therapy after renal transplantation in     non-risk patients is a triple therapy consisting of steroids, a calcineurin inhibitor and     MMF. The aim of this clinical trial is to combine a reduction of CNI using tacrolimus and a     concept of not using steroids in order to establish an immunosuppressive regimen in     immunologically non-risk patients that is efficient and causes as few side effects as     possible.   "
219470|NCT00724035|"     This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia     using two different nerve block techniques.      Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below     the collarbone) blocks will be performed to patients undergoing upper limb surgery.      The investigators will analyze how long it takes for anesthesia to be adequate for pain-free     surgery, thus determine the optimal technique for this kind of surgery.   "
219471|NCT00724048|"     The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic     treatment of Huntington's Disease.   "
219472|NCT00724061|"     RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells and slow the     growth of mycosis fungoides/Sezary syndrome. Ultraviolet light therapy uses a drug, such as     psoralen, that is absorbed by cancer cells. The drug becomes active when it is exposed to     ultraviolet light. When the drug is active, cancer cells are killed. Giving PEG-interferon     alfa-2b together with ultraviolet light therapy may kill more cancer cell.      PURPOSE: This is a pilot study of dose-escalating pegylated IFN-α-2b and PUVA or NB-UVB. The     purpose is to study the side effects and best dose of PEG-interferon alfa-2b to be given     together with ultraviolet light therapy in patients with stage IB, stage II, stage III, or     stage IVA mycosis fungoides/Sezary syndrome (CTCL).   "
219473|NCT00724074|"     The main purpose of this study is to determine if there is improvement in pain and other     patient outcomes when using a continuous wound analgesia system after total knee replacement,     compared to usual methods of pain control. Another purpose is to determine if the system     makes it easier for nurses to care for these patients.   "
219553|NCT00718159|"     The purpose of this study is to determine a safe dose of LY573636-sodium to be given to     patients with acute myeloid leukemia and to determine any side effects that may be associated     with LY573636-sodium in this patient population. Efficacy measures will also be used to     assess the activity of LY573636-sodium in acute myeloid leukemia and essential     thrombocythemia patients.   "
219474|NCT00724087|"     The use of energy from food changes when people sleep. However, it is still not known if     differences in the amount of nighttime sleep have an effect on the amount of energy that     people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to     perform their daily activities. This study is being done to test the hypothesis that the     daily use of energy in people who have a history of type 2 diabetes in their family will be     different after they have slept short hours for 16 days in comparison to when they have slept     longer hours for 16 days.   "
219475|NCT00724100|"     The purpose of this study is to determine the maximum tolerated dose of ALB 109564(a), a     novel tubulin inhibitor, and to assess safety, pharmacokinetics, and anti-tumor activity in     subjects with advanced solid tumors.   "
219476|NCT00724113|"     The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus     intensive mobilisation in shoulder capsulitis.   "
219477|NCT00724126|"     To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in     providing adequate relief of IBS symptoms.   "
219478|NCT00724139|"     The aim of this study is to evaluate the outcome of specific repetitive biomechanical     perturbation training on motor patterns.      The first hypothesis of this project is that footwear derived biomechanical challenges will     convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and     electromyographic) trough out the musculoskeletal kinematic chain.      The second hypothesis of the project is that repetitive exposure to in-situ (trough out the     gait sickle) introduction to a biomechanical stimulus would generate a process of motor     learning thus conveying plasticity of existing locomotor patterns and gait strategies.   "
219479|NCT00724152|"     This study examined how useful it is to teach veterans coping skills for dealing with     tinnitus, also called ringing in the ears. A psychological intervention, cognitive-behavioral     therapy, was used to teach coping skills even though tinnitus is not a psychological     disorder. Participants in Period 1 of the study were assigned to one of two groups for the     duration of the study and were blinded to their group assignment until the end of the study.     One group received education about tinnitus. The other group received education about     tinnitus plus additional ways to cope with problems associated with tinnitus such as sleep     disturbance and frustration. Participants were selected to participate if their tinnitus was     severe and they had been exposed to loud sound. Participants attended up to six weekly group     meetings. It was predicted that participants who were randomly assigned to the cognitive     behavioral therapy group would report a greater reduction in tinnitus severity than education     controls. During Period 2 of the study, a third standard care arm was added. Baseline and     outcome data of the 4 participants who completed the study after this third arm was added to     the study design are not reported.   "
219480|NCT00724165|"     The overarching goal of this project is to develop a culturally congruent intervention to     increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women).     The first phase will involve culturally and linguistically modifying an existing     evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive     Theory, to target sedentary Latinas. Then, we will conduct a pilot randomized clinical trial     to test whether the culturally-modified individually tailored intervention increases physical     activity levels in comparison to standard care comprised of bilingual health education     booklets.   "
219527|NCT00724776|"     This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of     albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients   "
224028|NCT00784745|"     The purpose of this study is to examine whether there is a causal relationship between     insulin resistance and/or glucose intolerance in the development of a defect incretin effect.   "
219481|NCT00724178|"     We have observed that vitamin D deficiency, as evidenced by low serum 25(OH)D concentrations,     is common in children and adolescents with HIV infection. To determine whether vitamin D and     calcium supplementation improve bone mineral content (BMC) and bone mineral density (BMD) in     HIV-infected children and adolescents, we propose a double-blind, randomized,     placebo-controlled trial comparing supplementation with oral vitamin D and calcium to     placebo.      The specific aims of this project are to:        1. Determine the effect of vitamin D and calcium supplementation on bone mineral accrual in          HIV-infected children.           We hypothesize that BMC and BMD will increase to a greater extent in HIV-infected          children who receive supplementation with vitamin D and calcium. This hypothesis will be          tested by comparing changes in BMC and BMD, measured by dual energy x-ray absorptiometry          (DXA), after one and two years of treatment in HIV-infected children and adolescents          receiving vitamin D and calcium supplementation compared to those receiving placebo.        2. Determine the effect of HIV infection and vitamin D and calcium supplementation on          indices of mineral metabolism and markers of bone turnover.           We hypothesize that indices of mineral metabolism and markers of bone formation and          resorption will return toward normal in HIV-infected children and adolescents who are          randomized to receive vitamin D and calcium supplementation. We will test these          hypotheses by comparing longitudinal changes in indices of mineral metabolism and bone          turnover markers in HIV-infected children and adolescents receiving vitamin D and          calcium supplement versus those receiving placebo        3. Evaluate if vitamin D stores are a determinant of bone mass in HIV infected children and          adolescents receiving HAART.      We hypothesize that vitamin D stores, as assessed by serum 25-hydroxyvitamin D levels, are an     important determinant of bone mass in HIV-infected children and adolescents receiving HAART.     We will test this hypothesis by evaluating whether measurements of bone mass are associated     with vitamin D stores, as measured by serum 25-hydroxyvitamin D levels and other indices of     mineral metabolism, in treated HAART-treated HIV-infected children and adolescents.   "
219482|NCT00724191|"     The purpose of this study is to determine if new MRI methods that measure various information     and chemical makeup in the brain, will give early information regarding response to treatment     in patients with brain tumors.   "
219483|NCT00724204|"     The aim of the trial is to evaluate safety of a follow on formula supplemented with     Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was     carried out. Eighty six months old children were recruited by the department of pediatrics of     Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a     follow on formula supplemented or not with the probiotic strain during 6 months. Fecal     samples were obtained at the recruitment, at 3 months and at the end of the trial. In     addition revision by the pediatrician was performed once a month and possible adverse effects     were recorded both by the pediatrician and by parents.   "
219484|NCT00724217|"     To determine the effects of a commercially available dietary modification plus nutritional     supplement regimen, the Standard Process 21 day Purification Program (SPPP), on serum lipids,     C-reactive protein (CRP), homocysteine, body mass index (BMI), body weight, blood pressure,     and heart rate variability (HRV) in normal weight (BMI < 26) and overweight (BMI 26 or above)     participants who have total cholesterol levels over 180.   "
219485|NCT00724230|"     The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol     combination therapy administered to patients with chronic hepatitis C. The study will exclude     (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with     low viral load. It is being conducted as a post-approval commitment, in accordance with the     Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
219486|NCT00724243|"     This study will gather information on the safety and efficacy of patients with rheumatoid     arthritis (RA) who are starting treatment with infliximab for the first time. Patients will     be treated in the usual manner according to local guidelines and normal clinical practice.   "
219489|NCT00724282|"     Available data suggest that obtaining adequate sleep is associated with a better ability of     the body to use carbohydrates as a source of energy and a lower risk of developing diabetes.     The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug     Administration for the treatment of people who complain of trouble falling or staying asleep.     This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the     sleep of people with insomnia may also improve the use of sugar in their body.   "
219490|NCT00724295|"     This is a post-marketing surveillance of patients with chronic hepatitis C treated with     PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the     study is to evaluate the safety and efficacy of the combination therapy. The study will also     compare the safety profile of the combination therapy among elderly patients and younger     patients.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
219491|NCT00724308|"     The purpose of this study is to evaluate whether a smoking cessation telephone care     coordination program is effective and feasible in VA Mental Health Clinics.   "
219492|NCT00724321|"     The objective of this study is to determine if single dose administration of inhaled iloprost     will reduce pulmonary artery pressure, reduce hypoxic pulmonary vasoconstriction and improve     arterial oxygenation at rest and during exercise at high altitude.   "
219493|NCT00724334|"     The purpose of this study is to evaluate the long-term effects of orally administered     SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001     study.   "
219494|NCT00724347|"     Many older subjects experience difficulty in understanding speech in noisy environments. Part     of this problem is related to changes that occur in the ear with age and compromise the     hearing of high-pitched sounds. Another part of the problem with speech understanding relates     to changes with age in the neural circuits of the brain that process different speech sounds.     Evidence suggests that these changes in neural circuits are particularly large if hearing     loss is present. Thus, while hearing aids may help compensate for hearing deficits by     amplifying speech sounds, additional treatment is necessary to restore optimal neural     connections in the brain so that speech sounds can be accurately distinguished from each     other. We are developing PC-based training programs in an attempt to restore optimal neural     connections. The current randomized trial will evaluate whether two months of training to     improve the ability to discriminate different consonant sounds in noise will also improve the     understanding of continuous speech and enhance auditory memory and other high-level auditory     functions.   "
219495|NCT00724360|"     This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive     B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg     intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till     progression. Response and HER2 expression are assessed each month by bone marrow aspirate.   "
219822|NCT00721773|"     This is a multicentre study examining the effectiveness of angiotension converting enzyme     inhibitor (ACEI), angiotensin receptor blocker (ARB) or a combination of both in reducing the     rate of decline in residual renal function (RRF) in continuous ambulatory peritoneal dialysis     (CAPD) patients.   "
219496|NCT00724373|"     The study is designed as a retrospective data review of medical records from participants     selected from specialist secondary and tertiary care centers across the United Kingdom (UK),     specializing in Hepatitis C treatment. The study is non-interventional and is designed to     identify subgroups of Hepatitis C Virus (HCV) genotype 1 participants in the 'real world',     including the relation between subgroup characteristics and treatment responsiveness.   "
219497|NCT00724386|"     The goal of this study is to determine the feasibility based on toxicity and response rate of     giving paclitaxel weekly with concomitant every-other week radiotherapy to limit skin     toxicity. This study will also seek to determine the maximally tolerated dose of Navelbine     added to this combination when followed by Filgrastim and the dose-limiting toxicities of     this regimen.   "
219498|NCT00724399|"     The purpose of this study is to evaluate women's level of knowledge and health practices     regarding cardiovascular health and identify barriers to appropriate health practice.   "
219499|NCT00724412|"     Comparison of two Dry Eye products   "
219500|NCT00724425|"     IPI-493 is a potent inhibitor of heat shock protein 90 (Hsp90) and is orally bioavailable via     a novel formulation.   "
219501|NCT00724438|"     Prior studies examining the pharmacokinetics, safety, and efficacy of the new     etonogestrel-containing single rod implantable contraceptive device, Implanon, did not     include women who exceeded 130% of ideal body weight. Yet, as these women comprise a     significant portion of the U.S. population, studies of Implanon in obese women are essential.     The proposed study represents an important first step in addressing the lack of data on     Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women     during the first 6 months of use and to provide data on the acceptability, side effect     profile, and ease of insertion, palpation, and removal in these women. We also aim to collect     samples for future validation studies of the use of the blood spot (finger-stick blood sample     on filter paper) as a method of determining plasma etonogestrel.   "
219502|NCT00724451|"     The goal of this study is to elucidate the reasons why patients with chronic hepatitis C     (CHC) would not be considered eligible for antiviral treatment. The study is conducted in     common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for     antiviral therapy will be treated at the discretion of the physician with either     peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in     accordance with approved labeling. A secondary objective of this study is to define     treatment failure and to evaluate the reasons for treatment discontinuation.   "
219503|NCT00724464|"     The objective of the study is to evaluate the rates of Hepatitis C virus (HCV) eradication     and relapse in participants treated with PegIntron and Rebetol in clinical practice in     Greece. Participants will not be treated as part of the study. Data on participants treated     in accordance with approved labeling will be collected retrospectively from approximately 30     sites in Greece.   "
219504|NCT00724477|"     The main objective of this study is to determine the percentage of patients who met the     low-density lipoprotein cholesterol (LDL-C) objective with INEGY, that were not under statin     monotherapy treatment.   "
219505|NCT00724490|"     The purpose of the study was to evaluate whether a unilateral Deep Brain Stimulation of the     right Nucleus Accumbens could lead to a more than 35% reduction of symptoms in patients with     a treatment resistant Obsessive Compulsive Disorder within two years.   "
219506|NCT00724503|"     This study is a randomized multi-center trial that will assess the effect of adding SIRT,     using SIR-Spheres microspheres, to a standard chemotherapy regimen of FOLFOX as first line     therapy in patients with non-resectable liver metastases from primary colorectal     adenocarcinoma.      Treatment with the biologic agent bevacizumab, if part of the standard of care at     participating institutions, is allowed within this study at the discretion of the treating     Investigator.   "
219507|NCT00724516|"     The purpose of this study is to evaluate the functionality of a new breast compression paddle     used in mammography for wire localization.   "
219508|NCT00724529|"     The purpose of this study is to understand the safety and effectiveness of infliximab when     used in clinical practice. This is a post-marketing surveillance study.   "
219509|NCT00724542|"     The purpose of this study is to determine whether therapeutic intervention on impaired     glucose tolerance in patients with coronary heart disease can decrease the incidence of new     onset DM.   "
219510|NCT00724555|"     The purpose of this study is to increase treatment of acute stroke with tissue plasminogen     activator (tPA) across the District of Columbia. This study, however, will not evaluate tPA     as an intervention.   "
219511|NCT00724568|"     This research study is evaluating an investigational combination of four drugs called     Revlimid® (lenalidomide), Velcade® (bortezomib), Dexamethasone and Doxil® (RVDD) as a     possible treatment for newly diagnosed multiple myeloma.   "
219512|NCT00724581|"     Patients undergoing lung resection due to pulmonary cancer can be compromised in their     postoperative period due to atrial fibrillation.      A retrospective analysis performed at our institution indicates that 30 % of the population     develope atrial fibrillation in the postoperative period.      Amiodarone is known to diminish the occurence of postoperative atrial fibrillation after     heart surgery, why this drug is chosen as a prophylactic agent for the mentioned population.      Amiodarone is administrated twice a day for 5 days at a dose of 600 mg oral treatment after     an initial loading bolus og 300 mg intravenously.   "
219513|NCT00724594|"     The purpose of this trial was to find the best dose of N-acetylcysteine (NAC) to decrease     brain injury in babies exposed to intrauterine infection without causing significant side     effects.   "
219528|NCT00724789|"     The primary purpose of this study is to collect data on the incidence of congenital     malformations in infants of women with an ongoing pregnancy after controlled ovarian     stimulation with recombinant follicle stimulating hormone /ganirelix followed by in vitro     fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI), and to compare this     incidence with that of a group of women who used a long protocol with a gonadotropin     releasing hormone agonist as historical controls.   "
219529|NCT00724802|"     Canavan disease is caused by Aspartoacylase deficiency. There is no treatment for the     disease, but there is a food additive that includes acetate . We suggest an early treatment     with acetate and a neurologic evaluation, including MRI, after 4 months of treatment. In any     case the treatment will be stopped at the age of 22 months, when myelinization is ended.   "
219514|NCT00724607|"     Active duty military personnel serving in the current and recent conflicts in Afghanistan and     Iraq are frequently exposed to blasts and other mechanisms of traumatic brain injury     (TBI).1,2 Although physical trauma is not unexpected during war fighting, survival after     blast-related head injury has become a common occurrence only in recent years. As such, the     associated cerebral damage is less well studied and understood.      The Brain Injury Outcomes (BIO) Study is a longitudinal study with the short-term objective     of better characterizing multi-modal outcomes in individuals who have sustained a brain     injury using a systems medicine approach. Long-term aims include monitoring participants for     signs of emerging symptoms or age-related vulnerabilities. Identification of abnormality     profiles for all severity levels of brain injury (from any source) reflects a second     long-range goal. Third, the investigators will examine and compare physiology between     Veterans who have sustained a Mild Traumatic Brain Injury (mTBI) with and without persisting     symptoms and various co-morbidities including posttraumatic stress disorder (PTSD). A control     group of Veterans who have not sustained a TBI will also be recruited for comparison. Fourth,     the investigators intend to facilitate the clinical use of advanced methodologies, such as     brain imaging and tissue measures, with the brain injured (and other populations). Finally,     the investigators will assess methods of analysis, combination and integration for     multi-modal data in search of diagnostic profiles. Increased knowledge of injury patterns and     the trajectory associated with brain injury could contribute to better methods of diagnosis,     monitoring and, perhaps, treatment.      This investigation has spawned several sub-studies, one of which was the Validation of Brief     Objective Neurobehavioral Detectors (BOND) of Mild TBI, which continues. The investigators     are collaborating with Harvard/Boston Children's Hospital in the Angiogenic Signaling     Signatures Identified in Stress and Trauma (ASSIST) sub-study. Oak Ridge National Laboratory     (ORNL) is integrating BIO Study multi-modal data.   "
219515|NCT00724620|"     This study aims to evaluate the efficacy and safety of peginterferon alfa-2b plus     weight-based ribavirin as initial treatment in chronic hepatitis C virus (HCV) genotype 1     patients. All patients will receive peginterferon alfa-2b plus oral ribavirin for 12 weeks.     At the end of this period, quantitative PCR will be used to determine the Early Viral     Response (EVR) at this point of treatment. Total treatment duration will be 48 weeks for     Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.   "
219516|NCT00724633|"     Patients currently receiving hemodialysis will be randomized to receive 1 of 3 dialysate     sodium prescriptions. The effects on blood pressure, interdialytic weight gain, thirst, and     intradialytic symptoms will be assessed.   "
219517|NCT00724646|"     Hattie Larlham is a specialized long-term care facility for pediatric and young adult     residents who are medically fragile and intellectually disabled, whose daily care is provided     by direct care staff, Habilitation Assistants (HA), in conjunction with nurses and other     direct care providers. The purpose of this study is to assess the perspectives of HA and     parents/legal guardians on end-of-life care in a long-term care facility for pediatric and     young adult residents who are medically fragile and intellectually disabled.   "
219518|NCT00724659|"     The purpose of this study is to determine the usefulness of contrast in ultrasonography of     the joints.   "
219519|NCT00724672|"     This 14-week study will observe the gene expression of certain immune cells in patients with     rheumatoid arthritis who receive etanercept, infliximab, and adalimumab. Patients at the     National Institute of Rheumatology and Physiotherapy, Budapest, who are already scheduled to     receive an anti-TNF agent will be asked to participate in this study. Patients will receive     their treatment (etanercept, infliximab, or adalimumab) as scheduled, and have blood samples     collected during the study and analyzed by the laboratory. Patient's response to their     treatment will also be studied based on x-rays and other examinations.   "
219520|NCT00724685|"     Continuous bupivacaine administration through an elastomeric pump (Pain Buster) has been     found effective for post operative analgesia in a large range of surgery. Ropivacaine is a     less toxic drug, never tested in the surgery of latissimus dorsi and serratus micro     anastomotic flaps (from the investigators knowledge). The aim of the study is to evaluate the     usefulness of this drug and device for post operative analgesia, associated with patient     controlled analgesia with morphine. For this purpose a controlled randomized double blind     trial against placebo (saline) is performed, enrolling 40 (20x2) patients during 3 years, in     order to measure total morphine consumption during the first 48 post operative hours and to     evaluate analgesia and sides effects of morphine in each group.   "
219521|NCT00724698|"     Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will     be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability     and clinical efficacy will be measured.   "
219522|NCT00724711|"     This protocol describes a prospective, randomized, open-label, multicenter study to evaluate     the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed     dose emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in virologically suppressed,     human immunodeficiency virus type 1 (HIV-1) infected subjects maintained on a     ritonavir-boosted protease inhibitor (PI/r)-containing antiretroviral (ARV) regimen. Duration     of treatment is 48 weeks.   "
219523|NCT00724724|"     The purpose of the study is to evaluate the efficacy and safety of Butylphthalide Soft     Capsules (En Bi Pu, NBP) in Secondary Prevention of Ischemic Stroke   "
219524|NCT00724737|"     The purpose of this study is to determine if functional MRI is precise enough to provide     information about the location of brain functions in patients who have brain tumors. This     might allow physicians to use a non-invasive procedure to assist with brain mapping prior to     surgery   "
219525|NCT00724750|"     The current standard for negative pressure wound therapy is the Vacuum Assisted Closure     Device (VAC), a commercial system that utilizes a computerized suction pump to apply negative     pressure to an open-cell poly-urethane foam dressing sealed over a wound. The VAC system is     effective but has some drawbacks:        -  The system is expensive.        -  There us conflicting data about the effectiveness of VAC therapy for infected wounds.        -  VAC therapy is difficult to use (and frequently fails) in wounds with excess fluid          drainage, and in wounds near body orifices.      Over the past 4 years, we have accumulated additional experience with negative pressure wound     therapy using wall suction applied to sealed gauze dressings with about 30 patients. We call     this method G-SUC and have used it when we have been unable to maintain a dressing seal with     the VAC system (due to excess drainage or wound location), for management if infected wounds.     We have found this method to be effective without any specific negative side effects.      Our specific aims are:        1. Compare the effectiveness of G-SUC and standard VAC therapy. Outcomes measured for each          method will include the proportional change in wound size over 1 - 2 weeks.        2. Compare the effectiveness of G-SUC and VAC system in controlling wound infections as          measured by the number of patients who are able to clear infection by 4 days.        3. Compare the failure of each method of therapy by documenting the number of dressing that          cannot be maintained because of fluid or suction.        4. Measure and compare the cost of wound treatment with the two methods including direct          cost and time spent at the bed side performing the dressing change.      Our hypotheses are:        1. G-SUC and VAC are equivalent for the treatment of uncomplicated wounds in the acute          care, in-patient setting.        2. G-SUC is more effective than VAC for management of infected wounds.        3. G-SUC is more versatile than VAC, and functional G-SUC dressings can be maintained in          situations where functional VAC dressings cannot.        4. Negative pressure therapy with G-SUC is less costly than VAC.   "
219526|NCT00724763|"     This research is designed to study the effects of needle acupuncture on blood pressure and     HRV by stimulating certain acupuncture points and meridians.   "
219530|NCT00724815|"     This study was a randomized, parallel group, double-blind, placebo controlled design to     compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch.     The primary objective of this study was to assess the proportion of subjects who were     headache pain free at two hours after patch activation.      Key secondary objectives included:        1. The proportion of subjects who were nausea free at two hours after patch activation.        2. The proportion of subjects who were photophobia free at two hours after patch          activation.        3. The proportion of subjects who were phonophobia free at two hours after patch          activation.   "
219531|NCT00724828|"     Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy     children and the carriage rate and distribution of Streptococcus pneumoniae serotypes   "
219532|NCT00724841|"     Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of     GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor     activity against a variety of cell lines and models from different tumor origins.   "
219533|NCT00724854|"     The objective of the study is to evaluate, in each group, the number of participants who     achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol.     The study will also assess whether RVR is a reliable predictor of sustained virologic     response (defined as undetectable viral load at 24 weeks post-treatment).   "
219534|NCT00724867|"     This is a continuation study to provide continuing treatment to subjects who completed study     HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of     belimumab(LymphoStat-B™) in subjects with SLE disease.   "
219535|NCT00724880|"     -  Running title: Effect of Clopidogrel on Postoperative Bleeding in Patients undergoing          Coronary Artery Bypass Surgery        -  Title: Clopidogrel and bleeding in patients undergoing coronary artery bypass grafting.          Is surgical delay necessary in patients using clopidogrel? And if so, which is the          safety time interval when clopidogrel should be stopped before surgery in order to avoid          bleeding and other related complications.        -  Background: By blockade of the platelet ADP receptor, clopidogrel inhibits the binding          of fibrinogen to the platelet GPIIb/IIIa receptor complex, thereby preventing platelet          aggregation from ADP stimulation. Some authors suggest that the platelet function is          completely recovered in 7 days after stopping clopidogrel in healthy subjects. Other          researches suggest full recovery of platelet function in 3 to 5 days.        -  Study objectives: To investigate if the interruption of the clopidogrel is necessary          before CABG in order to prevent bleeding and other complications.      To trace the increased risk patients for postoperative bleeding and to individualize the     therapy according to TEG measurements.        -  Design: A prospective, randomized mono- center study        -  Patients: Patients who are receiving elective or urgent CABG surgery and are pre-treated          at least 5 days before surgery with clopidogrel        -  Primary endpoint: To determine if there are significant differences in blood loss,          transfusions and rethoracotomies in the three selected groups of patients treated with          clopidogrel To asses the predictive value of the TEG clot strength in postoperative          bleeding in patients using Clopidogrel.        -  Secondary endpoints: Death, myocardial infarction, stroke, respiratory failure, renal          failure requiring dialysis, mediastinitis,readmission rates within 30 days from          discharge, and ICU and hospital lengths of stay        -  Risks: Using standard dose of aprotinin, we consider no increased risk in blood loss and          other related complications for this three groups of patients.        -  Possible benefits: Reduction of time delay in operating patients under treatment with          clopidogrel.      A more accurate time interval when clopidogrel should be stopped before surgery in order to     eliminate the risk of bleeding and associated complications.   "
219577|NCT00725179|"     Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to     assess length of oral vs IV treatment and overall healthcare costs.   "
221259|NCT00749138|"     A short 14 day phase 1 study examining 6 monotherapy doses of oral tamoxifen for safety in     chronic HCV patients who have failed standard treatment of peginterferon and ribavirin.   "
219536|NCT00724893|"     Treatment compliance is a key success factor in obtaining the full benefit of Pegetron     (peginterferon alfa-2b [PegIFN-2b] plus ribavirin combination) therapy for patients.     Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen     was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling.     The study will assess the effect of the newly approved Pegetron Redipen on treatment     compliance and its effect on sustained virologic response rates. Sustained virologic response     is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months     post-treatment.   "
219537|NCT00724906|"     This will be two separate but identical studies: ALSE-A-02a, ALSE-A02b. Each study is     designed to evaluate the diagnostic accuracy and safety of a single dose of 123I-ALTROPANE®     in subjects with upper extremity tremor for less than three years. Currently, no     radiopharmaceutical diagnostic imaging agent has been approved by the FDA in the U.S. for use     in diagnosing Parkinson disease and related Parkinsonian syndromes. The diagnosis of     Parkinsonian syndromes in the U.S. is based on clinical criteria only. The goal is to     demonstrate that 123I-ALTROPANE® paired with SPECT imaging permits a more accurate early     diagnosis of Parkinson disease than a clinical diagnosis by a general neurologist.   "
219538|NCT00724919|"     To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, post-     intervention in the selected medical centres   "
219539|NCT00724932|"     The current trial was designed to demonstrate faster recovery from a neuromuscular blockade     (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1     sugammadex compared to 50 µg.kg-1 neostigmine at reappearance of second twitch (T2) in     participants undergoing laparoscopic cholecystectomy or appendectomy under propofol     anesthesia, to compare safety and to evaluate operating room and Post Anesthetic Care Unit     (PACU) length of stay.   "
219540|NCT00724945|"     The purpose of the study is to compare the visual performance of two soft bifocal contact     lenses.   "
219541|NCT00724958|"     The current observational program was determined to collect data on the real life dosing     regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital     setting.   "
219542|NCT00724971|"     To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544)     in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).   "
219543|NCT00724984|"     The first part of the study will determine the highest dose of study drug that can be taken     without causing serious side effects in patients with lymphoma. The appropriate dose     determined from the first part of the study will be used in the second part of the study to     assess disease response in 2 different types of lymphoma patients.   "
219544|NCT00724997|"     The purpose of this phase I trial is to evaluate safety and tolerability of GHB01L1     administered as single dose intranasal aerosol for vaccination against influenza A (H1N1)     virus.      This study is performed further to assess local and systemic immune response and to analyse     pharmacokinetics (shedding) of a single dose GHB01L1 aerosol administered intranasally.   "
232299|NCT00893308|"     Patients' metabolic properties may affect their immune response. This study aims to assess     the effect of hosts' metabolic properties to viral infection.   "
219546|NCT00725023|"     Tennis elbow (Lateral epicondylitis) is a common condition seen in Family Medicine that gives     rise to pain, and can lead to loss of function and time off work.      The normal treatment for tennis elbow pain is oral pain relief medication (analgesia), and/or     physiotherapy, local massage or even surgery. In mainland China, tennis elbow pain has also     been treated using TDP © Heat-lamp therapy, and is considered to be an effective treatment     for this condition.      This study is a clinical trial that seeks to measure the effectiveness of the TDP © Heat-lamp     therapy to relieve tennis elbow pain without the use of oral pain medication.   "
219547|NCT00725036|"     This trial is conducted in Oceania.      The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to     s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.   "
219548|NCT00725049|"     This prospective randomized study will evaluate the integration success while supporting a     prosthesis for short implants placed into maxillary sites having minimal bone height that     would otherwise need sinus augmentation. The resources utilized during treatment will be     assessed.      Study (null) hypothesis: the overall benefit of using short length implants to avoid sinus     augmentation procedures will offset differences in the cumulative implant survival rates     observed between treatment groups.   "
219549|NCT00725062|"     RATIONALE: A donor peripheral stem cell transplant helps stop the growth of cancer cells.     When the healthy stem cells from a donor are infused into the patient they may help the     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Once the donated stem cells begin working, the patient's immune system may see the remaining     cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of     donor T cells may helps stop the patient's immune system from rejecting the donor's stem     cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of donor T cells in     treating patients with high-risk hematologic cancer who are undergoing donor peripheral blood     stem cell transplant.      Note: Only Phase I portion of study was performed. Due to slow accrual, study was closed     before Phase II portion of study.   "
219550|NCT00718120|"     This study will evaluate the immunogenicity and safety of GSK Biologicals' Trivalent split     virion influenza vaccine Fluviral for the 2008-2009 season in adults over the age of 18.   "
219551|NCT00718133|"     Haifa bay region is located close to a major industrial zone. The aim of the study is to     evaluate the health status of children living in Haifa bay region.      The health status will be evaluated using health questionnaires and spirometry.   "
219552|NCT00718146|"     This study is for a new marketing authorization application for the seasonal vaccine strains     in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza     vaccine from the Committee for Human Medicinal Products (CHMP)      Objectives:        -  To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion          influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG          CPMP/BWP/214/96.        -  To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009          formulation.   "
219554|NCT00718172|"     Up to 120 patients with chronic hepatitis C will be enrolled in a study of viral kinetics and     liver gene expression before and during combination therapy with peginterferon and ribavirin.     Adult patients with chronic hepatitis C virus (HCV) infection who have compensated liver     disease and have not received interferon in the past will be randomized into one of four     groups. Groups A and C will undergo liver biopsy before starting peginterferon therapy and     Groups B and D will undergo biopsy 6 hours after the initial dose of peginterferon.     Furthermore, Groups C and D will receive a run-in period of 4 weeks of ribavirin therapy     before starting peginterferon. All patients will receive the standard recommended doses of     peginterferon alfa 2a (180 mcg sc weekly) and ribavirin (1000 or 1200 mg daily for genotypes     1, 4-6 and 800 mg daily for genotype 2 and 3) for up to 48 weeks (24 weeks for genotype 2 and     3). All patients in Groups C and D, irrespective of genotype, will be pretreated with     ribavirin at a dose of 1000 or 1200 mg, depending on patient body-weight. After the initial     peginterferon injection, patients will have blood taken and symptoms recorded at 6, 24, 48,     72 hours and weekly thereafter for four weeks to assess viral kinetic response. Liver biopsy     tissue taken before or 6 hours after the initial dose of peginterferon will be assessed by     standard light microscopy and also subjected to RNA extraction and microarray analysis of     mRNA expression. Patients will be monitored carefully during therapy and tested regularly for     HCV RNA levels. Therapy will be given for 48 weeks, but will be discontinued early for     patients with genotype 1 infection if HCV RNA levels do not decline by at least 2 log IU/ml     by week 12 (lack of an early virological response) or do not decline to undetectable levels     by week 24 (lack of HCV RNA clearance). Patients with other genotypes with be treated for a     full course of therapy regardless of early responses. After completing therapy, patients will     be followed at 4 to 8 week intervals and undergo repeat medical evaluation with liver biopsy     24 weeks after stopping therapy.      The primary clinical criterion for success of therapy is a sustained virological response, as     marked by the absence of HCV RNA from serum at least 24 weeks after stopping. The focus of     this study, however, will be on viral kinetics comparing patients who were pretreated with     ribavirin (Groups C and D) to those who were not (Groups A and B) as well as on gene     expression studies assessing the effects of peginterferon on intrahepatic mRNA profiles by     comparing Group A and B and the effects of ribavirin by comparing Group A to Group C and     Group B to Group D. Results will also be compared between different HCV genotypes. These     studies are aimed at assessing the mechanisms of action of peginterferon and ribavirin     against HCV and evaluating the basis for the lack of virologic response to combination     therapy.   "
219555|NCT00718185|"     The study is being done to investigate what happens to sildenafil in the body and how long it     takes to get rid of this drug. Understanding how long the drug stays in the body and how it     is changed by the body will help doctors determine the best dose. We also want to learn how     well the medicine works based on the size of the dose or amount in the bloodstream.   "
219556|NCT00718198|"     This study is a retrospective cross-sectional study at one institution, where the     investigators compared diabetic patients admitted to Medicine Services from March-April 2006     (before CPOE was implemented) to patients admitted from October-November 2007 (one year after     CPOE implementation). Capillary blood glucose values, Hemoglobin AIC, diabetes medication     profile and demographic data were obtained to compare between groups. The investigators     hypothesized that a computer-based protocol that emphasizes basal-bolus and correctional     insulin orders and excludes sliding scale, in conjunction with nursing personnel inservicing,     improves outcomes.   "
219557|NCT00718211|"     To review the characteristics and treatment of gastrointestinal tumours at the two tertiary     centres in Singapore   "
219558|NCT00718224|"     The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with     Enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing     elective knee replacement surgery.      The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing     elective knee replacement surgery, and to document AVE5026 exposure in this population.   "
219559|NCT00718237|"     The purpose of the study is to evaluate whether V260 is effective and well tolerated in     Japanese healthy infants.   "
219560|NCT00718250|"     The purpose of this study is to assess the safety and tolerability of an 'AML Cell Vaccine'     in patients with poor prognosis acute myeloid leukaemia (AML).   "
219561|NCT00718263|"     This study will evaluate the safety and tolerability of nilotinib after failure of imatinib     therapy or imatinib therapy after nilotinib failure.   "
219563|NCT00718289|"     Background:      A concentrate for bicarbonate haemodialysis acidified with citrate instead of acetate has     been marketed in the recent years. The small amount of citrate used (one-fifth of the     concentration adopted in regional anticoagulation) protects against intradialyser clotting,     minimally affecting the calcium concentration. The aim of this study is to compare the impact     of a citrate- and acetate-based dialysate on systemic haemodynamics, coagulation, acid-base     status, calcium balance and dialysis efficiency.      Methods:      In 25 patients, 375 dialysis sessions, we will compare acetate (A) with citrate dialysate     with (C+) or without (C) calcium supplementation (0.25mmol/L) in a randomized single blind     cross-over study. Systemic haemodynamics will be evaluated using pulse wave analysis systems.     Coagulation, acid-base status, calcium balance and dialysis efficiency will be assessed using     standard biochemical markers.   "
219564|NCT00718302|"     The role of operative fixation of unstable, displaced lateral malleolus fractures is     well-established (Mayer, Mak, and Yablon). However, the optimal type of fixation remains the     subject of debate. Lag screw fixation alone is only appropriate for long oblique fractures in     younger patients (Tornetta). For all other patients, the choices for fibular stabilization     most commonly involve the use of plates and screws which can be placed on either the lateral     or posterior side of the bone, with or without lag screws. Lateral plating remains the most     popular option, but since the description of posterior plating in 1982 (Brunner), reports in     the literature have demonstrated some advantages of posterior over lateral plating (Ostrum,     Treadwell, Winkler, and Wissing) . These advantages include less dissection, less palpable     hardware, and decreased likelihood of intra-articular screw placement. However, there is only     a single retrospective study in the published literature directly comparing these two methods     (Lamontagne).   "
219565|NCT00718315|"     This 3 arm study will compare the efficacy and safety of three different dermatological     creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients     with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have     recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily     treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity     of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the     target sample size is 100-500 individuals.   "
219566|NCT00718328|"     Study Objective: To analyze if statins are effective in ameliorating perihematomal edema     evolution thereby reducing mortality and improving functional outcomes following spontaneous     intracerebral hemorrhage (ICH).   "
219567|NCT00718341|"     This study will evaluate the safety, tolerability and efficacy of multiple doses of AFQ056 in     patients with Fragile X Syndrome. The dose range will be 50 to 150 mg b.i.d. The primary     read-out of efficacy is reduction in Aberrant-Behavior Checklist score.   "
219568|NCT00718354|"     Due to evidence available both in terms of efficacy and safety of low molecular weight     heparin, its use for the prevention of thromboembolic disease in cancer patients undergoing     surgical intervention, and its extended use in higher doses for the prevention of recurrent     thromboembolism in cancer patients with established thrombosis, with a view that the     potential benefits for survival in cancer patients from low molecular weight heparin therapy     comes because of a biological activity, the dose of 1mg/Kg (50% of the full treatment dose)     for a period of 6 months coincident with 6 cycles of chemotherapy, has been chosen for this     study.   "
219569|NCT00725075|"     The purpose of this study is to determine whether MK-8435 (Org 25935) is more effective than     placebo in improving negative symptoms in participants with schizophrenia who are     concurrently treated with a stable dose of a second generation antipsychotic.   "
219570|NCT00725088|"     The purpose of this study is to determine whether exercise rehabilitation can reduce     mortality, reinfarction or heart failure of patients after acute myocardial infarction.   "
219571|NCT00725101|"     The Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments     (REFLECTIONS) Study is a 12-month, prospective observational study that will be utilized in     approximately 58 care settings in the United States (US) and Puerto Rico. It is designed to     examine treatment patterns and health outcomes of adult participants diagnosed by their     physician with fibromyalgia (FM) and who are starting any new pharmacologic agent for FM.      The primary benefit of this study is enhanced understanding of the disease state of FM and     the role that pharmacologic treatment plays, which may help to optimize management of FM.     This study will address current gaps in a rapidly growing body of literature on FM.   "
219572|NCT00725114|"     Different pathophysiologic mechanisms are responsible for the development of chronic pain     disorders. Pain pathways are triggered in part by ectopic discharges of voltage-sensitive     sodium channels, which are in abundance in both the peripheral and the central nervous     systems. Tetrodotoxin (TTX) is a selective blocker of Na+ channels and causes analgesia     either by decreasing the propagation of action potentials by Na+ channels and/or by blocking     of ectopic discharges associated with chronic pain. TTX is extracted from the puffer fish     (fugu). Results from animal pharmacology studies revealed that TTX is a more potent analgesic     than standard analgesic agents such as aspirin, morphine or meperidine.      At present, the management of severe cancer pain generally includes the use of opiates. This     can often result in undesirable side effects, and treatment with this type of medication is     not always effective. Because currently available pain-relieving therapy is unsatisfactory     for many patients, there is a need for new therapeutic approaches for the management of     moderate or severe cancer pain.      Recent studies indicate that intramuscular (into a muscle) or subcutaneous (under the skin)     injections of tetrodotoxin (TTX) may reduce pain in cancer patients who did not respond to     standard therapies.      The current proposed study (TEC-006) is designed to 1) demonstrate in a double-blind,     placebo-controlled trial that the subcutaneous 30 μg b.i.d. dose of TTX for 4 days is     effective in reducing pain outcome and improving quality of life; 2) characterize the onset     and duration of analgesia, and 3) demonstrate that TTX is well tolerated in patients with     inadequately controlled cancer-related pain.   "
219596|NCT00727337|"     The study is designed to examine the effectiveness of a computer-based auditory training     program to improve the benefits received by individuals who wear hearing aids. The study will     involve 3 groups - a computer-based training group, an active listening group which will     involve listening to books on CD, and a placebo group that receives no additional treatment.   "
219573|NCT00725127|"     Brief summary:      Aspirin (ASA) has been shown to provide marked benefits in primary and secondary prevention     of cardiovascular events. Substantial evidence suggests that low-dose ASA therapy should also     be used as a primary prevention strategy in men and women with diabetes who are at high     cardiovascular risk. On the other hand, there is current evidence on the potential benefits     of low-dose ASA therapy in subjects with impaired fasting glucose, including those with     metabolic syndrome. Most important, previous laboratory animal and clinical trial research     convincingly demonstrates administration time-dependent (with reference to circadian rhythms)     effects of ASA. Thus, the effects of ASA upon lipoperoxides, b-adrenergic receptors, and     blood pressure (BP) in clinically healthy subjects depend on the circadian timing of ASA     administration. The administration-time-dependent influence of ASA on BP was previously     demonstrated in a randomized trial on healthy women and other independent double-blind,     randomized, placebo-controlled clinical trials conducted, first, on clinically healthy     subjects, a second one on normotensive and hypertensive subjects, a third one on pregnant     women at high risk for preeclampsia and a fourth one in previously untreated patients with     mild hypertension. The findings of these BP studies are consistent; BP-lowering effect of     low-dose ASA is achieved when administered at bedtime but not upon awakening.      In keeping with the chronopharmacological effects of ASA and the previous findings suggesting     that ASA at low dose may exert a potential beneficial effect on BP, endothelium function and     cardiovascular function, this prospective, randomized, parallel-arm study will investigate     the potential influence of ASA on the primary prevention of cardiovascular, cerebrovascular     and renal events in subjects with either impaired fasting glucose (≥ 100 mg/dl) or previous     diagnosis of type 2 diabetes mellitus, who will receive low-dose ASA (100 mg/day) at     different circadian times (upon awakening or at bedtime) in relation to their rest-activity     cycle.   "
219574|NCT00725140|"     This is a observational, open, prospective, single arm cohort study within authorized SPC     conditions to describe the effectiveness of Almotriptan in treating acute migraine attacks     when pain is mild and in the first hour of pain in everyday primary care clinical practice.   "
219575|NCT00725153|"     The purpose of this study was to measure front surface deposits on contact lenses when worn     for ten hours.   "
219576|NCT00725166|"     To reach the goals of living longer in better medical conditions, many countries reach the     same conclusion: new strategies have to be developed to avoid, or at least limit, the effects     of age; this requires a better knowledge of the mechanisms of aging. Our project focuses on     the loss of muscle mass associated with aging, called sarcopenia. Sarcopenia unavoidably     leads to impaired mobility and poor balance, which contributes to loss of functional autonomy     and to increased prevalence for severe falls. Skeletal muscle also plays a central role as a     reserve for energy and amino acids. Hence, sarcopenia further triggers severe side metabolic     effects such as frailty among elderly persons. The precise mechanisms of muscle aging are     still mostly unknown, although many theories have been proposed.      The present study aims at better understanding the mechanisms of skeletal muscle loss     associated with aging. Using muscle biopsies from young and old subjects, the differential     expression profiles of mRNA will be obtained through chips that will evaluate more than 39000     transcripts. On the same samples, proteomic analyses will involve two complementary     approaches: (1) bidimensional electrophoresis (2DGE) coupled to mass spectrometry (MALDI-ToF)     for dominant proteins; (2) Western-blot (more than 800 antibodies) targeting regulating     proteins not detectable using 2DGE. Complementary histological studies     (immunohisto-fluorescence, confocal microscopy) will specify the localisation of the major     biomarkers in the muscle biopsies.      The results of that research will have applications in the medium term and will lead to     nutritional interventions to modulate specific metabolic pathways and improve the quality of     life in the elderly.   "
219578|NCT00725192|"     Sleep impairment is the most often reported of the 17 PTSD symptoms and is considered one of     the most refractory to treatment. This study proposes the use of sleep-directed hypnotherapy     to address sleep issues as a complementary element to empirically supported Cognitive     Processing Therapy (CPT) in treating PTSD in sexual and physical assault survivors.     Specifically the study aims to: 1) compare the results of sleep-directed hypnosis plus CPT     with CPT only, 2) to assess the relationship between sleep and PTSD symptoms, 3) to examine     relationships between sleep improvement, PTSD symptom improvement, and the therapeutic     elements (hypnosis, exposure, cognitive therapy) to determine mechanisms of action in the     intervention, 4) to assess the relationship between sleep and physical reactivity to     trauma-related cues and to other stimuli.   "
219579|NCT00725205|"     Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol     (Ribavirin) combination therapy as their usual medical treatment. The current study aims to     evaluate whether the previously introduced, and now widely accepted and implemented     educational program, which represents additional efforts in everyday practice to increase     patient compliance, will succeed in achieving adherence rate in treated participants similar     to the extent demonstrated by clinical trials.   "
219580|NCT00725218|"     Uterine contraction pain is a common problem after abortion. Optimal analgesic for such     suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable     non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of     prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress     the uterine contraction pain after abortion effectively.   "
219581|NCT00725231|"     Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is     significantly worse than that of aggressive B cell lymphomas. The prospects of elderly     patients are especially poor, with an estimated disease free survival of only 25% after three     years. Previous phase II trials have demonstrated a significant activity of the monoclonal     anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators     thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense     CHOP-14 in patients with previously untreated peripheral T cell lymphoma.   "
219582|NCT00725244|"     Aim:      To compare the efficacy, safety and number of sessions of bipolar eletrocoagulation (BEC) and     argon plasma coagulation (APC) in the management of the bleeding telangiectasias from chronic     radiation coloproctopathy (CRCP).      Methods:      Thirty patients with active bleeding from telangiectasias were enrolled in two groups (15 BEC     and 15 APC) and classified according of Saunders score. BEC settings were 50 W and APC     settings were 40 W and 1.0 l/min. Colonoscopy was the first exam to rule out synchronous     lesions and follow-up was performed with sigmoidoscopies. Clinical cure was defined as     cessation of bleeding and endoscopic cure was determined by absence of telangiectasias.     Failure was defined whenever more than 7 sessions or other therapy was necessary.   "
219597|NCT00727350|"     The study population will exist of patients with a histological diagnosis of NSCLC, stage T1,     T2 or T3NO who are not fit for or who refuse surgery. A prospective data analysis will be     performed on tumor response, potential acute and late toxicity and survival. A radiotherapy     dose of 4x15Gy or 3x 20Gy will be given over 2 weeks with dynamic 3D-conformal arc therapy     (Novalis TM)   "
219583|NCT00725257|"     The major environmental factors that increase the risk of type 2 diabetes, presumably in the     setting of genetic risk, are overnutrition and a sedentary lifestyle, with consequent     overweight and obesity. The high rate of weight regain has limited the role of lifestyle     interventions as an effective means of controlling glycemia long term. The aims of the     present study were: 1) To compare the effectiveness and safety of two nutritional protocols -     namely low-carbohydrate Mediterranean diet or low-fat diet - in newly-diagnosed, drug-naive     overweight patients with type 2 diabetes mellitus. The primary aim of the study was the     effect on hemoglobin A1c levels; secondary aims were time to introduction of the first     hypoglycemic agent, prevalence of the metabolic syndrome, percentage of patients meeting ADA     goals for risk factors (HbA1c, blood pressure, LDL-cholesterol, percentage of patients with     HbA1c < 7%.   "
219584|NCT00725270|"     This study tests the hypothesis that mifepristone will diminish cognitive distortion and     alleviate psychosis in patients with schizoaffective disorder.   "
219585|NCT00725283|"     This study is being done to evaluate the safety of a WT1 Antigen-Specific Cancer     Immunotherapeutic (WT1 ASCI) as post-consolidation therapy in adult patients with     WT1-positive Acute Myeloid Leukemia in first complete remission. It will also be analyzed to     what extent this treatment induces an immune response, specific to the malignancy.   "
219586|NCT00725296|"     This is a prospective, open-label, 1-arm, multicenter observational study to determine the     dose and time interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).   "
219587|NCT00725309|"     Chronic obstructive pulmonary disease (COPD) is a lung disease that is primarily caused by     cigarette smoking. The breakdown of elastin, a protein found in the lungs, can cause lung     damage and may contribute to the development of COPD. Some people may be more prone to     elastin damage and in turn to developing COPD than others. This study will examine whether     genetic factors are responsible for altering elastin function and increasing the risk of     developing COPD.   "
219588|NCT00725322|"     Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has     also been reported to be helpful for some pain conditions. The investigators have observed     prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin     Type A (BTA) in patients with certain types of neuropathic pain. The investigators propose to     study if addition of BTA extends pain relief compared to placebo when injected subcutaneously     into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is     perceived as painful).   "
219589|NCT00725335|"     This is a multi-centre prospective randomized controlled trial to explore the influence of     ischemia-reperfusion injuries elicited by pringle manoeuvre during radical excision on the     prognosis of Hepatocellular Carcinoma (HCC) patients.   "
219590|NCT00725348|"     This is a study of a new oral drug used for the treatment of psoriasis. All subjects will get     active medication, there is no placebo arm.   "
219591|NCT00725361|"     This is a research study of an investigational drug called ambrisentan (Letairis) in the     treatment and prevention of digital ulcers in patients with systemic sclerosis.   "
219592|NCT00725374|"     The primary purpose of this study is to compare changes in the expression of the     proliferation marker Ki-67 in malignant breast tissue after treatment with tibolone or     placebo in postmenopausal women who need to undergo surgery for primary breast cancer   "
221781|NCT00753844|"     The purpose of this study it to evaluate the safety and immune response of peptides (URLC10)     emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent     esophageal cancer.   "
219593|NCT00725387|"     Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool     for cancer detection and monitoring response to therapy. Sodium Fluorine-18 (F-18) was used     in the 1970s for bone scanning and can be used as a skeletal tracer in current PET/CT     scanners. The combined administration of F-18 and F-18 FDG in a single PET/CT scan for cancer     detection was not attempted to date. We hope to learn what is the best approach for detection     of cancer and thus to improve cancer treatment.   "
219594|NCT00725400|"     RATIONALE: Monoclonal antibodies, such as Cetuximab, can target tumor cells and either kill     them or deliver tumor-killing substances to them without harming normal cells.This is an     anti-cancer drug which has already been approved by the FDA for use in patients who have     Colorectal Cancer. Cetuximab can block tumor growth in different ways. Some block the ability     of tumor cells to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Radiation Therapy uses high-energy x-rays to kill tumor     cells and cause less damage to normal tissue . Giving the drug Cetuximab together with     Radiation Therapy may kill more tumor cells. Surgery is the most common treatment for     Colorectal Cancer to remove the tumor, as well as a small margin of surrounding normal tissue     and possibly nearby lymph nodes. Surgery is usually used in conjunction with other     conventional treatments such as Radiation Therapy. Radiation Therapy before surgery may make     the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation     Therapy after surgery may kill any tumor cells that remain after surgery.      Screening test such as Fecal Occult Blood Test (FOBT) and Colonoscopy has to be done. Tumor     markers for Colorectal Carcinoma are Carcinoembryonic antigen (CAE) and CA 19-9 and to assess     the response of tumor markers Carcinoembryonic antigen (CAE) and CA 19-9 will be used and     periodically Colonoscopy has to be done. Colorectal Cancer Surgery are Colon resection     (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation.      PURPOSE: Determine the tumor response rate treated with Cetuximab and Radiation Therapy Vs     Surgery before or after Radiation Therapy in patients with Colorectal Cancer from stage II to     IV   "
219595|NCT00727324|"     Ulcerative colitis is characterized by abnormal activation of, and damage to, the colon     epithelium, which is considered to be a central pathogenic mechanism. Activation of colon     epithelium cells in UC is associated with an abnormal high expression of Toll-like receptors,     including TLR-4, the major transducer of LPS, binding specifically the lipid A portion of     LPS. Alkaline Phosphatase binds and subsequently dephosphorylates LPS, thereby eliminating     the ability of LPS to activate TLR-4. This is expected to 1) prevent activation of the     intestinal epithelium and 2) prevent systemic inflammatory responses that result from     transmigration of endotoxin though the leaky inflamed intestinal mucosa. Therefore, it is     expected that administration of BIAP may attenuate or prevent the local and systemic     inflammatory response in patients with severe ulcerative colitis.   "
219598|NCT00727363|"     This study tries to determine whether the oral administration of a specific probiotic (good     bacteria) in premature infants hospitalized in a neonatal intensive care unit may prevent     infections and the development of a severe inflammatory disease of the bowel called     necrotizing enterocolitis. The investigators propose that premature infants not given     probiotics will colonize their gut with bad bacterias and develop infection.   "
219599|NCT00727376|"     To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during     radiation and/or chemotherapy treatment.   "
219600|NCT00727389|"     The objective of this study is to evaluate the capacity of muscular function and articular     amplitude in the aged women who participated in the Support Group and its influence on the     prevention of function decline of these women.   "
219601|NCT00727402|"     The LASH Contact Lens Study is a prospective longitudinal study of silicone hydrogel (SH)     contact lens wearers who sleep in their lenses for up to 29 consecutive nights (30 days) of     continuous wear (CW), with monthly disposal. Up to 207 healthy nearsighted or farsighted     patients with minimal or no astigmatism and no contraindications to CW lens use will be     followed for 1 year. The primary outcome measure is the time to development of a corneal     inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main     exposure of interest is corneal staining. Other key exploratory variables include bacterial     contamination of study lenses and inflammatory mediators found in the tear film.   "
219602|NCT00727415|"     This is a phase I - II multicenter, non-comparative, open label study in patients with     previously treated CLL aimed at defining the MTD of Lenalidomide given in combination with     Fludarabine, Cyclophosphamide and at evaluating the (CR) rate of FC given in combination with     the MTD of Lenalidomide (FCL).   "
219603|NCT00727428|"     The present study is intended to assess a novel formulation of FluLaval. The idea is to     obtain preliminary data on the safety and immune response to the FluLaval TF influenza     vaccine in adults. These data will serve as a basis for further studies involving different     populations. This protocol posting deals with objectives & outcome measures of the primary     phase/study.   "
219604|NCT00727441|"     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective     immune response to kill pancreatic cancer cells. Drugs used in chemotherapy, such as     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving vaccine therapy together with     cyclophosphamide may kill more tumor cells. It is not yet known whether vaccine therapy is     more effective with or without cyclophosphamide in treating patients with pancreatic cancer.      PURPOSE: This randomized clinical trial is studying the side effects of vaccine therapy and     to see how well it works when given with or without cyclophosphamide in treating patients     undergoing chemotherapy and radiation therapy for stage I or stage II pancreatic cancer that     can be removed by surgery.   "
219605|NCT00727454|"     Obstructive sleep apnea (OSA) is independently associated with important heart remodeling     that further contributes to overt heart failure. Recent evidences using echocardiogram     suggested that continuous positive airway pressure (CPAP) has beneficial effects mainly on     left ventricle parameters. However, the evidences regarding the right ventricle are scanty.     In addition, no previous studies evaluated morphological and functional characteristics in     OSA by magnetic resonance imaging (MRI) as well as the impact of CPAP.   "
219606|NCT00727467|"     The primary aim of the study is to evaluate the effect of an IACD i.e. Apple iPod-shuffle, on     freezing and gait speed in people with a diagnosis of PD through the implementation of a     randomised controlled trial. A secondary aim of the study is to evaluate the impact of such a     device on the quality of life of people with stroke through the administration of a     self-report questionnaire. The IACD will be pre-loaded with an individualised auditory cueing     frequency (metronome sound) matched to the walking speed of the individual with PD.   "
219607|NCT00727480|"     The purpose of this study is to develop a small, easily used device to detect a person's     blood flow in their fingertips.   "
219608|NCT00727493|"     The purpose of this study is to evaluate the influence of alendronate therapy on the wound     healing after dental implants in patients with osteoporosis.   "
219609|NCT00727506|"     Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992     administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade     III and IV).      Phase II Part: To estimate the efficacy and safety of BIBW 2992 monotherapy and BIBW 2992 /     TMZ combination therapy compared to TMZ monotherapy (three treatment arms) in patients with     recurrent GBM. To evaluate molecular determinants of response to BIBW 2992.   "
219610|NCT00727519|"     Pomegranate juice (PJ) consumption by hemodialysis patients will reduce the oxidative stress     and the incidence of infections, cardiovascular events and mortality.   "
219611|NCT00727532|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed.      PURPOSE: This clinical trial is studying how well sorafenib works in treating patients with     locally advanced or metastatic kidney cancer.   "
219612|NCT00727545|"     This was a double-blind community-based trial, placebo controlled. During 16 weeks, children     in the intervention group (GI, n=180) received iron fortified rice, and children in the     control group (GC, n=174) received rice with placebo. Anemia was considered present when     hemoglobin < 11.0g/dL. Comparison of mean variation on hemoglobin between groups was accessed     by using Student's t-test. Hemoglobin concentration improved in both groups, with mean     increase of 0.42 g/dL in GI (11.28±1.23 g/dL to 11.75±1.16 g/dL, p < 0.001), and 0.49 g/dL in     GC (11.06±1.13 g/dL to 11.51±1.16 g/dL, p < 0.001). Anemia decreased (p < 0.01) in both     groups (37.8% to 23.3% in GI and 45.4% to 33.3% in GC), with no differences between them.     Hemoglobin increase was significantly higher in children who received total amount of iron ≥     53.76 mg from fortified rice, compared to those who received less than this cut-off value     (0.94 g/dl vs 0.39 g/dl p=0.03). The results suggest that this type of intervention can be     useful in anemia control if fortified food intake is adequate.   "
219613|NCT00727558|"     This study seeks to evaluate the clinical performance of a new CE marked daily disposable     contact lens that contains a wetting agent to a recently improved daily disposable contact     lens.   "
219614|NCT00727571|"     This is a prospective, multicenter, observational, hypothesis-generating study exploring     mobility, Quality of Life and other physical performance measures among older, long-term stay     Nursing Home residents with CKD, with versus without anemia. Enrolled patients will     participate in the study up to a total of 26 weeks and be assessed at Weeks 1, 2, 14 and     26/End of Study. Based upon Week 1 hemoglobin and serum creatinine lab results, participants     will be categorized into 1 of 4 groups.   "
219615|NCT00727584|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known     which radiation therapy regimen is more effective in treating metastatic spinal cord     compression.      PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see     how well they work in treating patients with metastatic spinal cord compression.   "
219616|NCT00727597|"     The hope of this study is to gather data and information about the tolerability and     effectiveness of Lexiva versus Sustiva in patients who have have been generally     underrepresented in clinical trials.   "
219617|NCT00727610|"     Adverse Drug Related Events (ADREs) are a leading cause of Emergency Department (ED) visits     in Canada. However emergency physicians recognize only half of all ADREs in patients     presenting to the ED, missing opportunities to intervene. The objective of this study is to     develop a screening strategy that identifies patients with ADREs. Our hypothesis is that the     development of a user-friendly, reliable screening strategy for ADREs in patients presenting     to the ED is feasible. We believe that this will lead to improved patient care.   "
219618|NCT00727623|"     The purpose of this observational study is to assess predictors of in-hospital mortality in     patients with acute myocardial infarction admitted to Belgian hospitals.   "
219632|NCT00727831|"     RATIONALE: Drugs used in chemotherapy, such as methotrexate and leucovorin, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Glucarpidase may help return the level of methotrexate in the blood to a safe     range. Giving high-dose methotrexate together with glucarpidase and leucovorin may kill more     cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of methotrexate     when given together with glucarpidase and leucovorin in treating patients with newly     diagnosed primary central nervous system lymphoma.   "
219646|NCT00728013|"     In summary, the CHILLAS study will be the first multicenter study performed in a Chinese     population using a patient-level analysis to compare the effects and safety of intensive     statin therapy with that of moderate statin therapy. Therefore, it will determine whether     lower is better, that is, whether LDL cholesterol lowering to a level of approximately     100mg/dl provides a benefit inferior to that of LDL cholesterol lowering to a much lower     level; examine the role of inflammatory markers in predicting cardiac events and response to     statin therapy; and evaluate the effects of statin therapy on regression of coronary     atherosclerosis using IVUS.   "
219619|NCT00727636|"     Many IBD patients take immunosuppressive agents and we are uncertain as to their capacity to     mount a truly protective response after vaccination. If IBD patients do not have an adequate     immunological response, they may need to increase the dosage or get booster shots. Many     clinicians who treat patients with autoimmune diseases are asking if the vaccine is safe and     effective. Thus, this study has important clinical and public health significance because     more than one million people in the United States have been diagnosed with IBD.      There is not much studied about HPV and immunocompromised patients. Research on healthy women     who were immunized with a set of three HPV vaccines demonstrated significantly increased     antibody titers. In addition, they had significantly reduced HPV incident and persistent     infection and HPV-related disease (cervical, vulvar, and vaginal cancers, cervical     intraepithelial neoplasia, genital warts) through five years of follow-up compared to     controls who received a placebo. The HPV vaccine was well tolerated without significant side     effects.      The aims of this research are to measure the immune response in 9-26 year old IBD patients     who are on immunosuppressive agents after receiving the HPV vaccine compared with historical     controls. We will also evaluate the number and type of vaccine-associated adverse events as     well as the disease activity and flare-ups that occur after each dose of vaccine. We     hypothesize that IBD patients on immunosuppressive therapy will have have a similar immune     response to HPV types 6, 11, 16 and 18 at one month postdose 3 compared to healthy     age-matched historical controls.      The patient population includes IBD patients who are on immunosuppressive medications.     Recruiting approximately 100 patients will provide adequate power for the study. A blood     sample will be taken from all IBD patients to evaluate baseline antibody levels and markers     (e.g., ESR, CBC, albumin) before or immediately after immunization with the HPV vaccine. Lab     tests will be redrawn at 7 months to evaluate the level of antibody titers and follow the     markers. During the study, we will track basic laboratory measures, disease status by using     the Pediatric Crohn's Disease Active Index or Harvey-Bradshaw Index for UC, side effects from     the vaccinations, and other adverse events.   "
219620|NCT00727649|"     The purpose of this study is to evaluate and compare treatment with fiber and loperamide for     fecal incontinence.   "
219621|NCT00727662|"     This randomized controlled trial will compare the effectiveness of an Iyengar Yoga     intervention to a Wellness Seminar health education lecture series, for improvements in     energy, mood and biological functioning in breast cancer survivors with persistent,     post-treatment fatigue. It is anticipated that the Iyengar Yoga intervention will be feasible     and acceptable to breast cancer survivors with minimal side effects and that the Yoga     intervention will be effective in improving fatigue and physical performance.   "
219622|NCT00727675|"     This study involves the development of an integrated psychotherapy that addresses both     chronic pain and opioid dependence(POD).   "
219623|NCT00727701|"     The purpose of this study is to determine whether individualized wound prevention     instructions will lengthen the ulcer-free period in veterans with recently healed venous     ulcers.   "
219624|NCT00727714|"     The aim of the study is to examine possible changes in lung function, nitric oxide levels and     systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).   "
219625|NCT00727727|"     The objective of the Post Marketing Surveillance Study is to investigate the use of the     non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy     in patients with Morbus Parkinson. Neurologists in private practices in Germany should     document the safety and course of the disease/change of parkinsonian symptoms during     stabilisation on, or change over from other dopamine agonist treatment under routine     conditions. Piribedil should be prescribed according to its marketing authorisation.   "
219638|NCT00727909|"     This study is being conducted to evaluate the benefits of in-the-ear vs. open-fit     behind-the-ear hearing aids. We want to learn more about which patients prefer each type, so     we can make better choices about which type of hearing aid is best for which patients.     Participants in this study will try three different sets of hearing aids for 2 months each,     then we will evaluate the benefit of each type. Participants must be Veterans who are     eligible for audiology care at one of the three participating sites.   "
219626|NCT00727740|"     The purpose of this research study is to determine if indomethacin, an anti-inflammatory     medication in a class of medications known at NSAIDs (non-steroidal anti-inflammatory drugs)     can reduce the risk of pancreatitis after Endoscopic Retrograde Cholangio-Pancreatography     (ERCP.) The hypothesis is that indomethacin decreases the incidence and severity of post-ERCP     pancreatitis. Patients who are scheduled to undergo a ERCP will be enrolled. Following ERCP,     patients will be randomized to receive a dose of indomethacin or placebo (an inactive     substance) instilled into the duodenum via the biopsy channel of the duodenoscope. All     patients will be observed for 4 hours following ERCP which is part of routine clinical     practice. Patients with minimal pain will be discharged after this 4 hour observation period.     All patients will have baseline serum amylase levels which are repeated 2 to 4 hours after     the ERCP has been completed. Patients who have significant abdominal pain will be     hospitalized and evaluated for pancreatitis. Patients discharged to home will be contacted by     telephone the following day to ask them if they have had any complications of ERCP.   "
219627|NCT00727753|"     The objective of this study is to evaluate the effects of 2 intravitreal injections with     Ranibizumab or Avastin on endothelial function in subjects with neovascular macular     degeneration compared to patients with dry AMD.   "
219628|NCT00727766|"     This is a phase I study designed to test the safety of oral clofarabine when given as     consolidation therapy to older patients with AML in remission.   "
219629|NCT00727779|"     Prevention and treatment strategies for diabetes use exercise as the cornerstone. Even though     endurance training and strength training both improve insulin resistance, strength training     may be better suited for persons at risk for type 2 diabetes. We will expand our pilot     studies of muscle adaptation induced by resistance exercise training to determine the     biochemical mechanisms that will cause people with the Metabolic Syndrome to secure major     benefit from intense strength training.   "
219630|NCT00727792|"     The purpose of the study is to improve MRI examinations of the chest region that will result     in an improvement in patient care.   "
219631|NCT00727818|"     The purpose of this study was to evaluate by histology and histomorphometry, thirty human     osseous biopsies sampled from fifteen patients (2 biopsies per patient) following 3 months of     implantation. This study is part of a splitting-blind clinical investigation to compare the     performance and safety of INION GTRTM Biodegradable Membrane System to resorbable bilayer     Bio-Gide®-membrane of Geistlich biomaterials in enhancing bone regeneration after removal of     wisdom teeth.      The bone defect and alveolar cavity were augmented with Spongostan® dental 1x1x1cm, Johnson &     Johnson, Spreitenbach, Switzerland. The extraction sites were covered on one side with an     INION GTRTM Biodegradable Membrane System and on the other with Geistlich resorbable bilayer     Bio-Gide®-membrane.      This study was conducted in adaptation to the ISO 10993 Standard : Biological Evaluation of     Medical Devices, Part 6 (2007): Tests for Local Effects after Implantation.      This study was conducted in accordance with the requirements of the FDA (Department of health     and human services) Good Laboratory Practice (GLP) Regulations, 21 CFR 58 (revised as of     April 01, 2005) and in accordance with the requirements of the OECD Good Laboratory     Practices, reference ENV/MC/CHEM (98) 17, adapted by council on November 26th 1997.        -  Trial with medical device   "
221827|NCT00748306|"     The purpose of this study is to determine the safety and usefulness of GSK2190915 in     asthmatic patients who develop asthma symptoms following being challenged.   "
219633|NCT00727844|"     This study, conducted in Masan and Seoul, South Korea, investigated the effectiveness of     linezolid (LZD) in treating patients with extensively drug resistant tuberculosis (XDR TB).     Because regular medicines do not work well against XDR TB, many more people die from it than     from regular TB, which can be successfully treated by taking TB medication for 6 months.     Linezolid has been used to treat other kinds of infections, but has not been well studied for     TB. This study examined the side effects and effectiveness of prolonged treatment with     linezolid at two different doses.      People 20 years of age and older who have XDR TB were eligible for this 3-year study.      Participants underwent the following tests and procedures:        -  LZD treatment: Patients were randomly assigned to one of two study groups. Group 1          patients were observed for 2 months before starting LZD, while group 2 patients begin          taking LZD right away. Both groups began with a 600 mg daily dose of LZD. After patients          stopped coughing up TB germs (or after 4 months on LZD) they were randomly assigned          either to continue taking 600 mg of LZD for the rest of the study or to take a decreased          dose of 300 mg. In addition to LZD, patients continued to take their currently          prescribed TB medications.        -  Medical history.        -  Physical examinations each month during treatment.        -  Sputum collections once a week or more until 3 weeks after the patient was no longer          contagious.        -  Blood draws every week for 16 to 24 weeks and then once a month.        -  Urine collections at several time points.        -  Nerve and eye examinations before starting treatment and then monthly to look for          possible LZD side effects.        -  CT scans of the lungs three to four times the first year and once more later in the          study. For this test the patient lay on a table within the doughnut-shaped CT scanner          while special X-ray pictures are taken.      Patients who participated in a substudy had PET scans instead of the CT scans. For this test,     the patient was given an injection into a vein of a radioactive chemical that can be detected     by a special camera and viewed on a screen. The patient lay on a table within the     doughnut-shaped scanner while pictures were taken.   "
219634|NCT00727857|"     The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID),     combined with metformin versus pioglitazone taken alone and metformin taken alone in treating     Type 2 Diabetes Mellitus.   "
219635|NCT00727870|"     Shave biopsies are often uncomfortable during the healing process. This is a preliminary     study to determine if patients and clinicians prefer using PolyMem formulating dressings on     shave biopsy sites compared to the current standard of practice, which is antibiotic ointment     covered with a band-aid type dressing.   "
219636|NCT00727883|"     Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast     Cancer patients   "
219637|NCT00727896|"     Type 2 diabetes is a chronic metabolic disorder requiring lifestyle modification and     medicines, adherence to which has to be practised on a daily basis.      Motivation of patients to adhere to treatment is difficult in clinical practice. It is well     documented that majority of patients do not reach the glycaemic targets even in the centres     of excellence. Regular short service messages (SMS) through cell phones could have a positive     effect on behaviour and adherence to life style changes and compliance to drugs. It may be     practical and feasible to use information technology as an effective and simple tool for     motivating patients to adhere to the prescribed treatment regimen.      In diabetic patients, frequent reminders regarding the need for adherence to LSM and drugs by     the medical professionals will improve the compliance.   "
219665|NCT00728260|"     To further characterize the safety profile of Menactra vaccine and to identify any signals of     potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.   "
232300|NCT00893321|"     The purpose of this study is to compare muscle recession and myectomy on inferior oblique     muscle overactivity.   "
219639|NCT00727922|"     Oxaliplatin is a major antitumor agent but its use is limited by potentially disabling     neurotoxicity, characterized by a sensitive defect in the extremities.Mangafodipir is a MRI     contrast agent with antioxidant properties. Our previous laboratory works showed that     mangafodipir is able to prevent hematologic toxicity of several chemotherapy agents,     including oxaliplatin and to increase their antitumor activity. Preliminary clinical data     suggested that mangafodipir could prevent oxaliplatin neurotoxicity.The primary purpose of     the present study is to assess the protective effect of mangafodipir in patients who have a     already moderate oxaliplatin neuropathy and in whom the continuation of this treatment is     desirable because of significant antitumor effect.   "
219640|NCT00727935|"     Lateral episiotomy is a current care practiced with childbirth room. One of the problems     encountered with this surgical act is the residual pain on perineal scar level. Maximal     during the first 24 hours, this pain can persist several days or several weeks hampering to     variable degrees a normal recovery of autonomy and comfort of life. Some studies have shown     the interest of ropivacaine, local anaesthetic with a long action's duration for proctologic     surgeries and for the cure of inguinal hernia. A recent study shown the ropivacaine perineal     infiltration used prior perineorrhaphy allows an absence of post-partum pain for 24 to 27% of     cases and a first analgesics request delayed to ten hours.      Methodology: 165 parturients having an epidural analgesia and an episiotomy were enrolled.     The perineal infiltration was randomized according to 3 equal groups (placebo, ropivacaine     0,75%, lidocaine 1%) and realised prior perineorrhaphy. then The parturient were followed     during the 24 first hours. This study was designed as double blind and the study conduct was     standardized in order to get only variable such as the episiotomy infiltration.   "
219641|NCT00727948|"     Changes in major angiogenic proteins have been seen following initiation of tamoxifen and     aromatase inhibitor therapy in women with breast cancer. One source of these proteins is the     circulating platelet pool. The investigators hypothesize that in addition to their     anti-platelet properties, agents such as aspirin can be used as targeted anti-angiogenesis     therapy. The investigators will determine the influence of aspirin on the release of     angiogenic proteins from platelets in 35 patients with breast cancer.   "
219642|NCT00727961|"     The aim of this study is to evaluate efficacy and tolerability, and number of positive     response to treatment with CAELYX (50 mg/m^2), administered as monotherapy once per 4 weeks     to patients with metastatic epithelial ovarian cancer, resistant to previous platinum     therapy.   "
219643|NCT00727974|"     The purpose of this study is to determine if there are genetic variations that can explain a     genetic basis for cyclic vomiting syndrome (CVS).   "
219644|NCT00727987|"     The purpose of this study is to evaluate the safety and effectiveness of golimumab in     patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is     to evaluate the pharmacokinetics of golimumab.   "
219645|NCT00728000|"     The goal of this study is to determine the effect of chemotherapy on decreasing the size of     unresectable pancreas cancer thereby allowing it to be surgically removed. In addition, this     study may provide information on how tumors behave when exposed to certain types of     chemotherapy.   "
219647|NCT00728026|"     Retrospectively review the charts of all children who had heart rate variability, deep     breathing test, valsalva maneuver, tilt table test, thermoregulatory sweat testing,     quantitative sudomotor axon reflex test (QSART) completed and were cared for at Children's     Hospital of Wisconsin.   "
219648|NCT00728039|"     1. Characterize the quality of life of young children with CVS (i.e., psychological,          social, physical, school functioning) and the impact of the child's illness on the          parent's and family's quality of life (i.e., emotional, social, cognitive functioning,          communication, worry, daily activities and family relationships).        2. Assess symptoms of depression, anxiety, ADHD and behavioral problems in what our          preliminary data suggests is a psychiatrically vulnerable population.        3. Evaluate the associations between quality of life and psychiatric symptoms and the          frequency and intensity of CVS attacks.        4. Use the data generated from this study to develop a psychosocial intervention targeted          at young children with CVS and their families who evidence risk for functional          disability, with the aim of intervening as early as possible to limit the psychological          and social morbidity experienced by children with CVS and their and families.   "
219649|NCT00728052|"     Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise     healthy volunteers. This study is required because this drug is being developed for the     treatment of nicotine dependence. It is important to evaluate how this drug interacts in     healthy smokers. The study is planned to consist of a single part, with 4 dosing periods.     Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at     least 1 week of wash out between doses. In each dosing period 14 subjects will receive     escalating doses and 4 subjects will receive placebo. The actual doses used will be     determined based on the safety/ tolerability and pharmacokinetics during the previous dose.     It is expected that the duration of this study will be approximately 10 weeks.   "
219650|NCT00728065|"     Salvia hispanic (Salba) is postulated to increase satiety. This study determines the optimal     amount of Salba as well as whether liquid or solid enriched products will produce maximum     satiety. The results can gauge the effectiveness of Salba in weight loss programs. The study     has a randomized, double-blind crossover design which includes 10 test meals and capillary     blood sampling to perform glucose and insulin analyses (to determine blood glucose response     and blood insulin response).   "
219651|NCT00728078|"     The purpose of the investigators' study is to prospectively evaluate whether low-dose     thalidomide adjuvant therapy will improve the outcome of radiofrequency ablation for     hepatocellular carcinoma (HCC).   "
219652|NCT00728091|"     The primary objective of this study is to assess the efficacy of satavaptan versus placebo in     participants with dilutional hyponatremia due to SIADH.      Secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and     the clinical benefit in these participants.   "
219653|NCT00728104|"     This is a study with the principle goal being to learn about the use of L-Carnitine and     CoQ10, two vitamin supplements that are currently being used to treat Cyclic Vomiting     Syndrome, largely initiated by parents. We want to learn how effective these supplements are     compared to standard treatment, at what dose, and what onset of action in order to initiate     future prospective study on these supplements.   "
219654|NCT00728117|"     We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen     therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding     intolerance and shorten the time period that infants need to tolerate full enteral nutrition.     We also hypothesize that this intervention will minimize the alterations in intestinal     permeability that occur with these drugs and will improve the infants' hemodynamic response     to enteral nutrition   "
219655|NCT00728130|"     Hypothesis        1. The submandibular gland is not a lymphatic organ and usually remains uninvolved with          head and neck cancer despite the presence of metastatic disease in the lymph nodes that          surround it.        2. All the lymph nodes in the submandibular triangle can be removed without resection of          the submandibular gland.      Study Design      A better understanding of the frequency of submandibular gland involvement may lead to     refined treatment strategies for head and neck cancer, which can possibly spare removal of     the submandibular gland and potentially improve the long term side effects from therapy.   "
219656|NCT00728143|"     Our objective was to test whether the highly viscous polysaccharide incorporated into the     biscuit formulation would reduce the postprandial blood glucose response equally in healthy     subjects and individuals with type 2 diabetes.   "
219657|NCT00728156|"     Patients with diabetes are more likely to develop furring of their coronary arteries and     present with angina and heart attacks. Furthermore, after such an event, they have poorer     outcomes (higher rates of death) and survivors are more likely to have recurring symptoms.     Using a novel clotting chamber the investigators have shown that patients with diabetes are     more likely to develop blood clots. This study will look at the role of different blood     thinning medications in patients with diabetes. If successful, the investigators will provide     evidence to conduct large clinical studies to look at the role of additional blood thinning     medication in reducing heart attacks and strokes in patients with diabetes.   "
219658|NCT00728169|"     The purpose of this study is to identify community resources and challenges in improving the     health of community members with asthma.      The primary goal of this project is to use Community-Based Participatory Research methodology     to develop interventions aimed at improving asthma management in high-risk African American     asthmatics. This ground-up longterm approach has never been tested before in asthmatics.     The primary goal of this study will be accomplished with four specific aims:      Aim 1. Conduct focus groups to identify barriers to asthma management in the target     population.      Aim 2. Use a community advisory board (CAB) consisting of participants selected from the     various focus groups to gather information about solutions for the above barriers.      Aim 3. Use the information from the CAB to develop an intervention to improve asthma self     management behaviors in the target population.      Aim 4. Refine the developed intervention based on feedback from focus groups conducted in Aim     1.   "
219744|NCT00729326|"     This study is designed to compare the short-term effects and mechanisms of action of     exenatide with those of sitagliptin when either is added to an oral agent(metformin or a     thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with     inadequate glycemic control.   "
219659|NCT00728182|"     This is a randomized, double-blind, placebo-controlled, single-dose, design investigating the     safety, tolerability and efficacy of NA-1, a peptide designed to reduce ischemic brain     damage. Up to 200 male and female patients undergoing endovascular repair of brain aneurysm     will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after     completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo     interim procedures Days 2-4 and end-of study procedures on Day 30. Standard safety criteria     will be analysed. Efficacy endpoints include the ability of NA-1 to: 1) reduce the volume of     ischemic embolic strokes, 2) reduce the number of ischemic embolic strokes, 3) reduce     vascular cognitive impairment, and 4) reduce the frequency of large strokes induced by the     endovascular procedure. The plasma concentrations of NA-1 will also be analyzed.   "
219660|NCT00728195|"     The purpose of this study is to evaluate the efficacy and safety of 3 fixed doses of     JNJ-37822681 compared with placebo (an inactive substance that is compared with a drug to     test if the drug has a real effect in a clinical trial) after 6 weeks treatment and     olanzapine after 12 weeks treatment in participants with schizophrenia (psychiatric disorder     with symptoms of emotional instability, detachment from reality, often with delusions and     hallucinations, and withdrawal into the self).   "
219661|NCT00728208|"     This study will consist of 4 parallel cohorts of healthy volunteers (elderly male, elderly     female, young male and young female). Subjects will receive either GSK372475 1.5mg or placebo     for 28 days.   "
219662|NCT00728221|"     Ginseng has been used for many years in a wide array of anecdotal medicinal properties.     Animal and limited clinical research points to the vascular effects of Korean Red Ginseng     (KRG). The present project aims to assess the efficacy of KRG and contribution of its     factionated components on various indices of vascular function in healthy individuals. Our     primary objective is to compare the acute effects of KRG and placebo on endothelial function.     Moreover, our secondary objective is to evaluate the effect of isolated KRG factions on     arterial stiffness, blood pressure and vasoactive markers. We hypothesize that (1)     consumption of KRG will cause an improvement in endothelial function in healthy individuals,     as compared to placebo; (2) consumption of KRG will cause an improvement in arterial     stiffness and blood pressure in healthy individuals, as compared to placebo; (3) the     ginsenoside faction of KRG is primarily responsible for the anticipated vascular effects.   "
219663|NCT00728234|"     The study included analysis of longitudinal recordings of amplitude-integrated EEG (aEEG)     tracings on a weekly basis in preterm infants and evaluation of their neurodevelopmental     outcome at the age of three years.      Aim of the study was to observe if there is a correlation of the aEEG tracings of the first     weeks of life to later neurodevelopmental outcome and to evaluate if aEEG can be used as     prognostic tool.   "
219664|NCT00728247|"     Hypothesis: Kinematic parameters can be used to monitor changes in three-dimensional head     movements after Manual Therapy treatments.      Subjects who have some level of cervical dysfunction will be examined by an experienced     Osteopathic physician. During the clinical assessment of cervical lateral flexion, kinematic     data will be recorded. Subjects will be treated using manual therapy techniques and kinematic     data will be recorded again at set intervals after the treatment.   "
219666|NCT00728273|"     The aim of this study is to identify the effect of a school-based food fortification     intervention with multi-micronutrients with or without deworming to improve anemia,     micronutrient status, cognitive function, health (morbidity and reinfestation rate) and     growth (ponderal) in Vietnamese primary schoolchildren.   "
219667|NCT00728286|"     The purpose of this study is to assess platelet dependent thrombogenicity in patients after     acute coronary syndrome using an ex vivo arterial injury model.   "
219668|NCT00728299|"     Increases in carotid artery intima-media thickness (IMT) are correlated with increased risk     of stroke and myocardial infarction. The purpose of this study is to assess if pomegranate     juice will retard the carotid (IMT) progression rate in men and women who have one or more     existing cardiovascular risk factors (current cigarette smoking, hypertension, low     HDL-cholesterol, and/or high LDL-cholesterol) upon entrance into the study.   "
219669|NCT00728312|"     The purpose of this study is to test whether treatment with Aripiprazole leads to a reduction     in methamphetamine craving and use in patients diagnosed with methamphetamine dependence.     Patients presenting at the Omaha VA Medical Center for treatment of methamphetamine     dependence, and meet inclusion criteria for the study will be invited to participate.     Participation in the study will last for approximately 14 weeks.   "
219670|NCT00728325|"     This prospective randomized study evaluates the impact of Supportive Employment (SE) compared     to standard vocational rehabilitation (VRP) on occupational, sobriety, psychiatric, and     quality of life outcomes and health care costs for veterans with chronic posttraumatic stress     disorder (PTSD).   "
219671|NCT00728338|"     The purpose of this study is to determine the effects of supplementing diets of     hyperlipidemic men with DHA (docosahexenoic acid) on risk factors for cardiovascular disease.     We hypothesize that supplementing diets of hyperlipidemic men with DHA will decrease the     plasma concentrations of CRP (C-reactive protein), inflammatory cytokines, and soluble     adhesion molecules. We further hypothesize that DHA supplementation will decrease serum     triglyceride concentrations and increase HDL concentration.   "
219672|NCT00728351|"     The present study is designed to evaluate the efficacy and safety of fixed combination     therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes     inadequately controlled with prior metformin monotherapy.   "
219710|NCT00728858|"     Nifedipine and barnidipine act as calcium channel blockers, and are widely prescribed for     pressure control of prehypertension and stage 1 hypertension.      CYP3A4 is responsible for the metabolism of nifedipine and nifedipine, while the contribution     of CYP3A5 remains ambiguous. This study is aimed to analyze the association between     antihypertensive effects of nifedipine as well as barnidipine and single nucleotide     polymorphisms of CYP3A4, CYP3A5 and calcium channels.   "
220202|NCT00726895|"     The purpose of this study is to evaluate and compare the dose proportionality of 324 mg     Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg     capsules) in healthy adult volunteers when administered under fasting conditions.   "
219673|NCT00728364|"     Anderson-Fabry disease is a rare X-linked lysosomal storage disorder due to the deficiency of     alfa-galactosidase A (AGAL). The subsequent accumulation of glycosphingolipids may lead to to     cardiac, renal, and central nervous system impairment as well as premature death. Recently     published studies suggest that the true incidence of the disease may be underestimated in     certain risk groups, e.g. in patients with chronic kidney disease (CKD).      Therefore, the investigators initiated a multicenter case-finding study in Austria by     screening patients with chronic kidney disease not yet on renal replacement therapy.     Molecular isoforms of globotriaosylceramide (Gb3), characterized by different chain lengths     of their N-acyl residues, will be determined in a urine sample. Characteristic parameters,     including the ratio of C24/C18 isoforms will be used for identifying patients liable to have     the disease. A positive result will be confirmed by biochemical and genetic testing.      A sample size of 5.000 chronic kidney disease patients is envisaged allowing for detection of     1 to 25 patients with Anderson-Fabry disease.   "
219674|NCT00728377|"     Women diagnosed with gestational diabetes mellitus (GDM) are at substantially increased risk     of developing type 2 diabetes and obesity, currently at epidemic rates in the United States.     GDM, therefore, identifies a population of women at high risk of developing type 2 diabetes     and thus provides an excellent opportunity to intervene years before the development of this     disorder. It is well recognized that acute as well as chronic physical activity reduce     fasting plasma glucose as well as improve glucose tolerance in type 2 diabetes. Recent     studies have suggested that women with higher levels of physical activity have reduced risk     of GDM. Therefore, we will test the hypothesis that an exercise intervention is an effective     tool for preventing GDM among women with a history of GDM.   "
219675|NCT00728390|"     This study will explore the combination of the oral drug PF-00299804 and intravenous     CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given     separately to patients in prior studies, and this study is to establish the safety and     efficacy of the combination.   "
219676|NCT00728403|"     The study is a 2 phase double blind randomized placebo control trial. The objective is to     asses the metabolic and therapeutic effects of American Ginseng (Panax quinquefolius L.)     extract and Korean Red Ginseng (steamed Panax C.A. Meyer) extract in the management of type 2     diabetes in a 12 week period. One Hundred and twenty subjects with type 2 diabetes     (hyperglycemia key inclusion criteria: HbAlc≥6.5% - ≤ 8.1% ) will participate in the study     (36 men and 36 post-menopausal women).   "
219677|NCT00728416|"     This study seeks to prospectively demonstrate that Nasonex is better than placebo in     relieving nasal congestion in patients with seasonal allergic rhinitis.   "
219678|NCT00728429|"     RATIONALE: Aerobic exercise may help prevent side effects caused by chemotherapy and help     improve heart health.      PURPOSE: This randomized clinical trial is studying the side effects of aerobic exercise and     to see how well it works in patients receiving chemotherapy for cancer.   "
219679|NCT00728442|"     The objective of the study is to evaluate how the use of OncoDoc2, a computerized     guideline-based decision support system, could improve the compliance of multidisciplinary     staff meeting decisions with local clinical practice guidelines in the management of     non-metastatic breast cancer.   "
221623|NCT00751621|"     This study is a continuation of the study ZLB06_001CR with the objective of assessing     efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life     in patients with PID.   "
219680|NCT00728455|"     This trial will be conducted in the United States of America (USA). The aim of this clinical     trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated.      Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349     or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as     well as subject reported adverse events will be evaluated. If safe to proceed, the next group     of subjects will be given a higher dose and the safety evaluation performed again before     proceeding. In total, 5 dose levels will be evaluated.      Subjects will be administered a dose and remain in the clinic until the morning of Day 8     after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic     samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for     repeat blood draws and safety labs. Day 22 is the final study visit.   "
219681|NCT00728468|"     Research in test tubes suggests that may affect cytochrome P450 2D6 (CYP2D6), an important     enzyme that is responsible for eliminating many drugs that cancer patients need to take,     including dextromethorphan. The purpose of this study is to test the impact of PF-00299804 on     the activity of CYP2D6, and how the human body handles dextromethorphan.   "
219682|NCT00728481|"     The primary aim of this study was to determine the proportion of patients with esophageal     eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal     reflux disease (GERD).      This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD     would receive relief from taking the medication Nexium or a steroid called Pulmicort.      The study also evaluated the accuracy of pH monitoring (acid exposure) within the esophagus     as a predictor of endoscopic, histological and symptomatic response in patients with EE.   "
219683|NCT00728494|"     Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C.     Patients in the first one will receive a patient assistance program, and patients in the     second group will not. All patients will receive PegIntron and Rebetol according to label.   "
219711|NCT00728871|"     A. To investigate the relationship between serum titer of anti-HPV16 antibody and     clinicopathological factors of cervical cancer patients.      B. To investigate that if the serum titer of anti-HPV16 antibody could be a prognostic factor     in the cervical cancer patients.      C. To investigate the serum titer of anti-HPV16 antibody in HPV16-infected populations with     various disease status such as infection only, precancerous lesion, and early and advanced     cervical cancer.   "
219712|NCT00728884|"     This observational, prospective clinical study evaluates the performance of the Certain     Prevail implant system to show potential crestal bone and soft tissue preservation following     the crestal bone. It will also evaluate implant performance.      Study (null) hypothesis: The preservation of crestal bone for the Certain Prevail implants     will be the same as that for standard non-platform switched implants from contemporaneous     studies (historical controls).   "
219771|NCT00729677|"     RATIONALE: Learning how often patients experience nausea and vomiting after receiving     anti-vomiting medicine and chemotherapy for colorectal cancer may help doctors plan better     treatment and improve patients' quality of life.      PURPOSE: This clinical trial is studying delayed nausea and vomiting in patients with     colorectal cancer receiving standard anti-vomiting medicine during the first course of     chemotherapy.   "
219684|NCT00728507|"     Although effective therapy for tuberculosis is available, TB continues to cause significant     problems worldwide, and rates of multi-drug resistant (MDR) TB cases are on the rise. A major     obstacle to the control of TB is poor adherence with lengthy (usually 6 months) and     complicated treatment regimens. Incomplete TB treatment can lead to serious consequences such     as increased severity of illness and death, prolonged infectiousness and transmission in the     community, and the development of drug resistance. The development of new treatment     strategies with more stronger drugs could lead to shorter and simpler regimens. A TB     treatment regimen that allowed treatment duration to be meaningfully decreased would have     important public health implications.      This trial will compare the effect and safety of a new oral regimen to that of the standard     regimen for the first phase of treatment for pulmonary tuberculosis.      The experimental regimen will consist of the following:        -  Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered          once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.      The standard control intensive phase regimen will consist of the following:        -  Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once          daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.      Following intensive phase therapy (the study phase), all patients will be treated with a     non-experimental continuation phase regimen.      In mice, the combination of Moxifloxacin and Rifapentine have cured the animals significantly     faster than the standard regimen and this study will be the first step to see if the     potential is also there in humans.   "
219685|NCT00728520|"     The drug that will be used in this study is called Azacitidine. Azacitidine belongs to a     group of drugs which may restore normal control in cancer cells by affecting the genes and     proteins in the body. Azacitidine is approved by the FDA for the treatment of Myelodysplastic     Syndrome (MDS), a pre-leukemic bone marrow disease. The purpose of this study is to find out     what effect the drug Azacitidine has on Acute Myeloid Leukemia (AML) in elderly patients.   "
219686|NCT00728533|"     An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and     Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer     Requiring Androgen Ablation Therapy.   "
219687|NCT00728546|"     Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in     patients with anti-TB medication induced hepatitis.   "
219688|NCT00728559|"     In the literature there is conflicting data on administration of local analgesia in addition     to the general anesthesia to the trocar sites during laparoscopy, We believe that adding     local analgesia to the general anesthesia during laparoscopy is beneficial . the current     study will evaluate prospectivly the impact of local analgesia on postoperative pain and     recovery in patients undergoing operative laparoscopy   "
219689|NCT00728572|"     The purpose of this investigation is to determine the effect of Logan Basic Technique apex     contact adjustment (LBT); on the motor recruitment pattern in the erector spinae group via     surface EMG.   "
221897|NCT00757588|"     The purpose of this study is to compare the effects of saxagliptin with those of placebo as     add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and     52 weeks.   "
219690|NCT00728585|"     RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and     radiation therapy in young patients undergoing stem cell transplant.      PURPOSE: This randomized phase II trial is studying palifermin to see how well it works     compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation     therapy in young patients undergoing stem cell transplant.   "
219691|NCT00728598|"     Fractalkine (FKN) is a chemoattractant and adhesion molecule for leukocytes. Angiogenic     effect of FKN also has been reported. We investigate FKN-mediated angiogenesis in ocular     angiogenic disorders.   "
219692|NCT00728611|"     to evaluate the influence of PRGF treatment on patient suffering from OA knee   "
219693|NCT00728624|"     EGAST 2008 is a prospective, non interventional, multicentric study (approximately 2000     isolates from 15- 20 sites).      Objectives:        -  Comparison of antimicrobial susceptibility using disc-diffusion method        -  Assessing prevalence of beta-lactamase producing strains among clinical isolates          obtained from hospital in-patients   "
219694|NCT00728637|"     The primary objective of the FIT Heart Study was to test the effectiveness of a     hospital-based standardized screening and educational intervention targeted to family members     of patients hospitalized with CVD, to increase adherence to CVD prevention guidelines.   "
219695|NCT00728650|"     This study will review the treatment and outcomes of patients having primary and metastatic     hepatic malignancies. Patients treated with surgical resection, percutaneous radiofrequency     ablation (RFA), and transarterial chemoembolization (TACE) will be compared with patients not     receiving these treatments. Tumor recurrence and survival data will be compared to the     published literature to determine the efficacy of current treatment strategies in this     patient population.   "
219696|NCT00728663|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Cetuximab may also stop the growth of     prostate cancer by blocking blood flow to the tumor. Giving docetaxel together with cetuximab     may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with     cetuximab and to see how well it works in treating patients with metastatic prostate cancer.   "
219697|NCT00728676|"     To validate the outcome measures and the tolerability of Kuvan treatment in the improvement     of behavioral symptoms in 10 selected adults with Phenylketonuria (PKU) with or without     mental retardation.   "
219698|NCT00728689|"     The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a     single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy     volunteers.   "
219728|NCT00729118|"     RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Lenalidomide may stop the growth of multiple myeloma by blocking     blood flow to the cancer. Giving vorinostat together with lenalidomide may kill more cancer     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when     given together with lenalidomide after autologous stem cell transplant in treating patients     with multiple myeloma.   "
221840|NCT00748475|"     The purpose of the study is to examine the effect of alpha-neurofeedback while subjects     listen to a noise on tinnitus.   "
219699|NCT00728715|"     Some studies have concluded that high-dose inhaled steroids (IS) are effective in the     clinical control of patients with bronchiectasis, however the high doses needed provokes some     adverse effects and lower doses are not effective. Combined treatment with budesonide and     formoterol have demostrated to be effective in patients with asthma and COPD achieving the     reduction of steroid dose thanks to the adition of a long-acting beta 2 agonists. There are     no studies in the literature analysing the effect of combined treatment in patients with     bronchiectasis. The objective of this study is to compare the efficacy and safety of     formoterol-medium dose of budesonide in a single inhaler versus high-dose of budesonide in     the clinical control of patientes with non-cystic fibrosis bronchiectasis.      Study Design:      Randomized (3 months) parallel groups study.      Patients:      Patients with bronchiectasis diagnosed by high-resolution CT scan and chronic obstructive     airway obstruction.      Exclusion:      Asthma and current or past smokers.      Methods:      Run in period in all patients with high dose of budesonide (1600 mcg/day) for 3 months. After     that, randomization into two groups: 1. The same treatment (1600 mcg/day of budesonide) or     combined treatment with lower dose of budesonide (18 mcg/day of formoterol and 800 mcg of     budesonide) in a single turbuhaler inhaler during 3 months.      Studied variables:      Clinical, functional, quality of life, microbiological and number of side effects.   "
219700|NCT00728728|"     This study will investigate adjunctive pregnenolone for patients with schizophrenia and     schizoaffective disorder.   "
219714|NCT00728910|"     The investigators propose to investigate if using a combination of medications that may     improve cholesterol give additional benefit to that gained from the statin medication,     Lipitor. It is recommended that patients who meet certain criteria for risk of heart disease     take a statin medication to improve cholesterol and hopefully reduce risk of heart disease.     The combination therapy will include Lipitor, Niaspan, and investigational medication (known     as ABT335) in a class of drugs called fibrates. We are looking to see if and how these three     medications together might improve risk factors for atherosclerosis and influence HDL     cholesterol. The study will also look at the safety and any side effects that might be     associated with this combination of medications.   "
219735|NCT00729209|"     This is a Phase 1 study, involving a 29-day treatment period, designed to evaluate the     pharmacokinetics and the effectiveness of investigational study drug ARRY-371797 in treating     rheumatoid arthritis in patients receiving stable doses of methotrexate, and to further     evaluate the drug's safety. Approximately 30 patients from the US will be enrolled in this     study.   "
219736|NCT00729222|"     The study will estimate the effects of rolofylline, alone and in addition to loop diuretic     therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients     with heart failure and renal impairment.   "
221898|NCT00757601|"     This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of     single doses of MK1006   "
219701|NCT00728741|"     This study will locate areas in the brain that help people devise action plans to carry out     complex tasks requiring use of strategy. The ability to plan strategically is impaired in     patients who have had a stroke affecting the front parts of the brain. This study will use     functional magnetic resonance imaging (fMRI) to examine the activity of different areas of     the brain during the formulation and execution of plans.      Right-handed healthy volunteers between 18 and 60 years of age may be eligible for this     study. Participants come to the NIH Clinical Center four to five times to complete the     following procedures:      Visit 1 - Screening        -  Medical history        -  Physical and neurological examinations      Visit 2 - MRI brain scan (if one has not been done within the past year)      MRI - This test uses a strong magnetic field and radio waves to obtain images of the brain.     The scanner is a metal cylinder surrounded by a magnetic field. The subject lies on a table     that can slide in and out of the scanner, wearing earplugs to muffle loud noises that occur     during the scanning.      Visits 3 to 5 - Task training sessions and two fMRI scans      Functional MRI involves taking MRI scans while the subject performs a task in order to learn     about changes in brain regions that are involved in the performance of the task. Subjects are     trained in two tasks (see below) and then perform the tasks while in the MRI scanner.        -  Task 1: The subject presses computer keys in response to the direction of arrows shown          on the computer screen. The keys are pressed according to a given set of rules the          subject is taught.        -  Task 2: This task is similar to task 1, but the subject is also asked to remember          certain previous actions and responses.   "
219702|NCT00728754|"     This prospective, randomized study will evaluate the performance of the Osseotite Certain     Prevail implant when compared to that of the non-lateralized version of the implant.      Study (null) hypothesis: the crestal bone changes that take place after placement and loading     of the Osseotite lateralized implants will be the same as for a similar but non-lateralized     Osseotite Certain implant.   "
219703|NCT00728767|"     The purpose of the study is to determine whether a brief intervention (a short conversation     build on the principles of motivational interviewing) is effective in lowering self reported     alcohol use in heavy drinkers.   "
219704|NCT00728780|"     The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from     ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.   "
219705|NCT00728793|"     This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced     and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal     growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and     histone deacetylase (HDAC). The study is designed to establish the safety, including the     maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of CUDC-101.   "
219706|NCT00728806|"     This study will examine the peritoneal tissue, serum and dialysate proteins of peritoneal     dialysis (PD) patients with different types of peritoneal solute transport by differential     proteomics techniques.      This study will be performed to identify the molecular difference between different types of     peritoneal solute transport and explore biomarker for early detection as well as early     intervention of peritoneal ultrafiltration failure.   "
219707|NCT00728819|"     The purpose of this study is to compare two different marketed PICC (peripherally inserted     central catheter) designs. Clotting rates, procedural bleeding and ease of catheter insertion     will be compared. It is hypothesized that the non-tapered design has a lower clotting rate     and is easier to place than the tapered design. Bleeding rates are expected to be about the     same.   "
219708|NCT00728832|"     The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test     dose administration on the PK profile of a single epidural dose of DepoDur (extended-release     epidural morphine) in patients undergoing major upper abdominal surgery. A secondary     objective was to evaluate the safety and efficacy profile.   "
219709|NCT00728845|"     RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, carboplatin, and     paclitaxel and work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.     Giving hydroxychloroquine together with carboplatin, paclitaxel and bevacizumab may kill more     tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of     hydroxychloroquine when given together with carboplatin, paclitaxel, and bevacizumab and to     see how well they work in treating patients with recurrent advanced non-small cell lung     cancer.   "
219786|NCT00721305|"     The purpose of this study is to determine whether the long-term administration of statins may     benefit the clinical and immunological evolution in HIV-1-infected individuals before the use     of antiretroviral therapy is required.   "
219713|NCT00728897|"     Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because     we plan to have only single capsules administered in the later phase clinical trials but we     have not had a 100mg strength before. As this is a new previously untested strength we need     to ensure that the PK is similar to that achieved using 4 x 25mg. The study will also assess     the effect of high fat food on the PK of the 100mg capsule. The study is planned to consist     of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. There     will be a week wash out between each dose. In the three dosing periods subjects will either     received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or     100mg GSK598809 capsule in a fed state. Subjects will return to the centre for follow-up 7-14     days after the final dose. It is expected that the total duration of the study should be     approximately eight weeks.   "
219733|NCT00729183|"     This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with     Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The     primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine     compared to placebo at 12 months.   "
219734|NCT00729196|"     The purpose of this study is to determine whether a low-fat or low-glycemic load diet is more     effective for controlling weight and blood glucose in persons with type 2 diabetes.   "
219776|NCT00729742|"     This study will use imaging to look at tumor response to erlotinib (Part I) and the     combination of erlotinib and dalotuzumab (Part II).   "
219715|NCT00728923|"     Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3%     of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as     obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only     medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with     SRI treatment, most patients continue to experience significant OCD symptoms, impaired     functioning, and diminished quality of life. Recent evidence suggest that a different     neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target     glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from     OCD. In this study we are recruiting patients to receive the drug NPL-2003, which is thought     to modulate the neurotransmitter glutamate, added to whatever other OCD medications they are     taking in a 12-week open label study.   "
219716|NCT00728936|"     First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.   "
219717|NCT00728949|"     The purpose of this study is to determine whether IMC-A12 offers increased progression-free     survival (PFS) associated with IMC-A12 monotherapy and IMC-A12 in combination with an     antiestrogen therapy in patients with hormone receptor positive advanced or metastatic breast     cancer that have experienced disease progression on antiestrogen therapy.   "
219718|NCT00728962|"     This prospective, multicenter study evaluates the performance of the Osseotite Prevail     implant when to support a short fixed bridge with immediate occlusal loading, providing the     patient with the use of a temporary prosthesis until the final prosthesis is made.      Study (null) hypothesis: This is an observational study in which no concurrent control group     will be observed. Results of the study will be compared with the performance of other     Osseotite implants from published Osseotite multicenter studies.   "
219719|NCT00728975|"     The project's primary purpose is to establish a network of Hospice Palliative Care settings     using a common and consistent method of assessing and documenting bowel functioning in order     to be able to carry out future collaborative studies of constipation treatments. The     secondary goal is to gather normative data on current bowel care function and outcomes of     current treatments which can be used to determine sample size calculations for future     controlled trials of bowel management protocols. In order to complete this goal the project     requires a thorough assessment of current nursing practice in regard to bowel care.   "
219720|NCT00728988|"     This present study is specifically designed to examine the efficacy and safety of a high     pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic     of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.   "
219721|NCT00729001|"     This is a dose exploration study to assess the safety and immunogenicity of two doses of the     candidate HRV vaccine at different virus concentrations in the target age group (infants     approximately 2 months of age and previously uninfected with human rotavirus) and receiving     concomitant administration of routine vaccinations. The study also aims at exploring the     effect of unrestricted feeding on the immunogenicity of the vaccine.   "
219722|NCT00729014|"     The purpose of this study is to identify incidence of Chinese herb nephropathy in a medical     center   "
219723|NCT00729027|"     The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on     to ongoing statin treatment in a double-blind manner in comparison with placebo, in the     management of patients with primary hypercholesterolemia considered as inadequately     controlled despite their ongoing statin treatment.      The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C     level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters     will be assessed as secondary objectives.   "
219724|NCT00729040|"     The purpose of this study is to determine whether online peer support will increase adherence     to an internet-based pedometer walking program.   "
219725|NCT00729053|"     -  Multi-Center        -  Randomized        -  Open-Label Study of single agent IMO-2055        -  Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)   "
219726|NCT00729079|"     This pilot study is intended to demonstrate that we can actually deliver the Diabetes     Prevention Program intervention well and to show that it is likely effective. We will use     results from this pilot study to support our application to The National Institute of Health.     NIH is asking for health care centers to show ways to provide this treatment at a reasonable     cost. We propose to demonstrate successful and sustainable use DPP's lifestyle intervention     in a primary care health care setting (University of Rochester Primary Care).   "
219727|NCT00729092|"     Specific Aims:      • The primary objective is to delineate the brain structures that are involved in pain using     Positron Emission Tomography (PET) imaging.      Hypothesis:      Pain will result in increases in metabolism and neuronal activity in specific delineated     areas of the brain.   "
219729|NCT00729131|"     The research plan proposes to develop translational studies in humans that will identify host     susceptibility factors that confer vulnerability to the prototypal air pollutant, ozone.     Ozone is a ubiquitous urban air pollutant and associated with increased emergency room     visits, and co-associates with other air pollutants, to increase mortality in high risk     groups (cardio-pulmonary disease) of the population.The results will have significant impact     upon and aid in understanding mechanisms of pro-oxidant lung injury, airway     hyperresponsiveness, and adverse health effects, that occur during and following exposure to     inhalable airborne irritants.   "
219730|NCT00729144|"     This study focuses on the validation of the Adaptation Index instrument as a measurement of     adaptive behaviors used to reduce symptoms of FI and to describe the use of adaptive     behaviors among women with FI.   "
219731|NCT00729157|"     This phase II trial is studying how well aflibercept works in treating patients with     recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine     therapy. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor     and by carrying tumor-killing substances directly to thyroid cancer cells.   "
219732|NCT00729170|"     The aim of the project is to determine if milk supplementation during a caloric restriction     program facilitates the lost of weight, improves the appetite control and attenuates the     decrease of bone mineral content in low-calcium consumer women.   "
225296|NCT00801307|"     This clinical trial will include healthy volunteers, COPD patients and asthmatic patients who     will breathe He/O2 78:22, He/O2 65:35 and medical air consecutively in a randomised order.   "
219737|NCT00729235|"     This clinical investigation is a device-based open, prospective, multicenter two-arm     randomized trial, comparing patients who are treated in the slow VT zone versus patients who     are not treated in that zone.      The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin     Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and     health authorities will be informed prior to any use of a newer device if applicable.      All patients will have a 3-zone detection configuration programmed. The slow VT zone will be     defined by programming the detection parameters as follows:        -  Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we          recommend to adjust this parameter to: resting rate + 30 bpm)        -  VT detection rate: 150 bpm      PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.      The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF     are also left to the investigator's judgment.      Patients will be randomized at implant to have the slow VT zone programmed as a monitoring     zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm).     The randomization table will be generated by Sorin Group/ELA Medical.   "
219738|NCT00729248|"     The study is a laboratory investigation comparing the regulatory effects of different     immunosuppressive therapies in an in vitro human MLR assay of selecting specific     immunosuppressive therapy to promote a regulatory profile and determining possibly newer     accepted dosing and drug concentrations for agents most associated with this regulatory     profile.   "
219739|NCT00729261|"     Identifying the optimal time of extubation in a brain injured population should improve     patient outcome. Brain injured patients usually remain intubated due to concerns of airway     maintenance. Current practice argues that unconscious patients need to remain intubated to     protect their airways. More recent data however suggests that delaying extubation in this     population increases pneumonias and worsens patient outcomes.      We designed a safety and feasibility study of randomizing brain injured patients into early     or delayed extubation. The purpose was to gain insight into patient safety concerns and to     obtain estimates of sample size needed for a larger study.   "
219740|NCT00729274|"     The purpose of this study is to determine whether nebulized hypertonic saline solution     reduces the admission rate 48 hours after initial treatment in the emergency department, when     compared to normal saline solution (placebo). We hypothesise that patients with bronchiolitis     who receive nebulized hypertonic saline solution will have less respiratory distress, less     duration of symptoms and therefore less risk of being hospitalized than those receiving     normal saline solution.   "
219741|NCT00729287|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,     or coming back. The use of selenium may keep bladder cancer from growing or coming back. It     is not yet known whether selenium is more effective than a placebo in preventing cancer     recurrence in patients with bladder cancer.      PURPOSE: This randomized phase III trial is studying selenium to see how well it works     compared with a placebo in preventing cancer recurrence in patients with bladder cancer.   "
219742|NCT00729300|"     The problem of cocaine dependence remains a major medical, social, and legal concern. Several     studies have suggested that disulfiram may be beneficial for the treatment of cocaine     dependence. A common assumption has been that disulfiram treatment, by increasing DA     availability, enhances the aversive aspects of stimulants. This study aims to measure plasma     activity in those with the C/C DBH genotype, which is associated with higher DBH activity     subsequently making the disulfiram treatment more effective, as well as determine the effects     of treatment with disulfiram on cocaine self-administration using a human laboratory model of     cocaine self-administration.   "
219743|NCT00729313|"     The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the     treatment of patients with digestive fistulae.   "
219798|NCT00721461|"     A study to evaluate the tolerability of electrostimulation applications with an     investigational device known as the MedPulser DDS.   "
219745|NCT00729339|"     Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In     Taiwan, this disease is increasing gradually because the investigators' eating style is     closing to Western world.      Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent     is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of     prokinetic agent in the management of GERD.   "
219746|NCT00729352|"     The research plan proposes translational studies in relevant animal models and human subjects     in order to identify host (genetic) susceptibility factors that confer vulnerability to the     prototypal air pollutant, ozone. The results will have significant impact upon, and aid in,     understanding mechanisms regulating pro-oxidant lung injury, production and secretion of     airway mucins, and clearance of respiratory mucus, and adverse health effects, that occur     during and following exposure to airborne respiratory irritants.   "
219747|NCT00729365|"     The purpose of this study is to determine if the early treatment with a blood pressure     medication (an ACE Inhibitor) can prevent or delay the development of kidney disease     (microalbuminuria) in patients with Type 1 diabetes who have normal blood pressure and urine     albumin levels.   "
219748|NCT00729378|"     The Jump-In study will prospectively assess the effects of impact exercise on skeletal     development in young girls, including bone mass, bone mineral density, and bone geometry. We     hypothesize that girls who regularly participate in impact loading exercise will accrue     greater skeletal mass, increase bone density and undergo structural adaptations that in     combination will improve bone strength compared to girls who do not participate in impact     exercise.   "
219749|NCT00729391|"     The purpose of this study is to test the effectiveness of a woman-focused HIV prevention     intervention combined with voluntary counseling and testing (VCT), compared to VCT only, and     VCT combined with an attention-control nutrition intervention.   "
219750|NCT00729404|"     Investigation of two transdermal hormone patch formulations for contraception regarding     inhibition of ovulation over a period of 3 treatment cycles in healthy young female     volunteers   "
219823|NCT00721786|"     The purpose of this study is to determine the percentage of English- and Spanish-speaking     smokers worldwide who can stop smoking using an Internet stop smoking site.      Latinos and non-Latinos are welcome to participate.      We will stop recruitment on March 19, 2011. Participants will be able to use the site until     May 19, 2011.   "
219751|NCT00729417|"     Evaluation of Obstetrical Risk Factors for the development of Urinary and/or Fecal     Incontinence according to a questionaire      The questionaire will be filled by the study investigators after the women participating in     the study sign their consent. The study is based solely on a questionaire and does not     include any physical examination, blood exam or intervention.      The study will be performed on the premises of Maaynei Hayeshua medical center. The inclusion     criteria include women above the age of 18 who arrive to Maaynei Hayeshua Medical center for     any reason. The data will be transferred to a computerized data base and analyzed     statistically.   "
219752|NCT00729430|"     Doctors use magnetic resonance imaging (MRI) to obtain detailed pictures of the inside of the     body. This study will evaluate a new MRI technique in people who have recently had a heart     attack. Researchers will also examine the effect of fish oil supplementation on heart health     in study participants.   "
219753|NCT00729443|"     The study is carried out in order to investigate safety, tolerability and pharmacokinetics     after administrating single and fractionated doses of AZD3241 to healthy volunteers   "
219754|NCT00729456|"     This study was an attempt to confirm the results of an earlier experiment in which the     benefit of an education programme was assessed in a group of people with diabetes complicated     by ulceration of the foot. Foot ulcers are the source of considerable suffering and cost and     carry a high risk of amputation: they are difficult to heal and approximately 40% recur in     the first 12 months. The earlier experiment (published by Malone and colleagues in 1989)     indicated that a single hour-long education session appeared to lead to a three-fold     reduction in the numbers of ulcers which recurred after successful treatment. It was not     possible to confirm these findings in the present study in which patients from three     specialist clinics in Nottingham and Derby, UK, were allocated either to receive a     one-to-one, individually targeted, education programme in the own home (and reinforced after     one month by a telephone call), or to receive usual care. The group who received the     education reported better recommended foot care behaviour (intended to minimise the risk of     injury) at 12 months but despite this, there was no difference between the two groups in the     percentage who suffered either a new ulcer (41% education versus 41% usual care) or     amputation (10% and 11%, respectively). While the benefit of education is undeniable in     general, it was not possible to show that this particular teaching session had an impact on     the occurrence of new disease in this group of patients.   "
219755|NCT00729469|"     The purpose of this study is to determine the safety and efficacy of ospemifene in     postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain     associated with sexual activity.   "
219756|NCT00729482|"     This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free     survival rate (primary end-point) and response rate, toxicity, and overall survival     (secondary end-points) in patients with metastatic and/or advanced inoperable gastric cancer.      Eligibility criteria include histologically proven gastric/gastroesophageal junction cancer     who failed previous first-line standard treatment with fluoropyrimidine and platinum-based     chemotherapy.      Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted     according to the observed clinical toxicities. Treatment will be continued until disease     progression or patient's intolerability to the study drug.      Total of 54 patients will be enrolled to decide whether the proportion of patients who are     free from progression at 4 months (16 weeks), P, is less that or equal to 0.15 or greater     than or equal to 0.30 to assess the treatment outcome in 48 patients assuming drop-out rate,     10%.   "
219757|NCT00729495|"     Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is     bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be     randomized to yield approximately 80 completers. The study is an open label, randomized,     2-way crossover with single dosing followed by a 7-day washout period between treatment arms   "
219758|NCT00729508|"     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with     allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived     peptide desensitising vaccine, currently being developed for the treatment of cat allergy.     This study will investigate the efficacy of 4 treatment regimens of Cat-PAD in cat allergic     subjects following challenge to cat allergen in an environmental exposure chamber (EEC).   "
219759|NCT00729521|"     An important challenge for the field of injury prevention and control is the translation of     research findings into effective community-based prevention programs and practices. The     National Center for Injury Prevention and Control believes that dissemination research can     overcome this challenge by providing insight into the structures and methods needed to     translate injury control research into everyday practice. The proposed dissemination research     study will rigorously assess whether the use of a facilitative system can successfully     bridge the gap between injury prevention and control research and the implementation of     evidence-driven, community-based programs, policies, and practices. The facilitative system     links communities with academic partners to provide communities with the skills and resources     needed to help facilitate the community health improvement process. The system identifies     what assets are available within communities, as well as the skills and resources needed to     work through the community health improvement process. The facilitative system will then     provide technical assistance, best practices guides, and direct consultation in carrying out     all phases of the community health improvement process. This information is designed to     increase community capacity in community assessment, coalition development, accessing and     interpreting local injury prevention data, searching and selecting evidence-based research,     and program planning and evaluation. The study will use a randomized community trial design     to evaluate fall injury occurrence and process measures of program implementation in three     groups of communities:        -  a control group receiving no special resources or guidance related to fall injury          prevention or the community health improvement process;        -  a Standard Program group receiving modest funding to implement an evidence-based          fall prevention program in their local community;        -  a Facilitative System group receiving facilitative system support in addition to the          resources provided the Standard Program group.      We hypothesize that the Facilitative System program will be more effective at:        -  reducing fall-related injuries in the elderly;        -  building community coalitions that are goal-oriented and sustainable;        -  implementing community-based, evidence-driven fall prevention programs that are both          tailored to the community needs and yet faithful to empirically-tested fall prevention          research studies   "
219760|NCT00729534|"     This study will examine how research volunteers experience their participation in studies in     order to develop surveys to be used by research centers trying to improve the experience of     their participants.      People 18 years of age and older who have participated in an NIH research protocol within the     past 2 years as someone with a medical condition under study may be eligible for this study.      Eight participants will participate in a moderator facilitated focus group in a discussion     about being in research studies. An observer audiotapes the discussion and takes written     notes. The focus group discussion lasts about 1 to 1 (Omega) hours.   "
219761|NCT00729547|"     The investigators examined the therapeutic efficacy of neurofeedback in depression subjects.     The investigators hypothesize that 5 weeks neurofeedback training will be able to alleviate     depressive symptoms.   "
225396|NCT00802620|"     The purpose of this study is to compare amniotic membrane associated with conjunctival     autograft versus conjunctival autograft alone in the treatment of recurrent pterygia.   "
219762|NCT00729560|"     Polycystic Ovary Syndrome (PCOS) is the major cause of infertility in the United States. Many     women with PCOS demonstrate insulin resistance and a compensatory hyperinsulinemia.This is     due to both an intrinsic form of insulin resistance unique to PCOS and, in many cases,     acquired insulin resistance due to obesity. The importance of this observation lies in the     fact that hyperinsulinemia appears to play an important pathogenetic role in the     hyperandrogenism and anovulation of both obese and lean women with PCOS.   "
219763|NCT00729573|"     The MTN-003 HIV prevention study include the use of microbicides, substances that kill     microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil     fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to     determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on     bone mineral density (BMD).   "
219764|NCT00729586|"     This randomized phase II trial studies how well temsirolimus with or without megestrol     acetate and tamoxifen citrate works in treating patients with endometrial cancer that has     spread to other places in the body and usually cannot be cured or controlled with treatment,     has returned after a period of improvement, or is persistent. Temsirolimus may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can     cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate and     tamoxifen citrate may fight endometrial cancer by blocking the use of estrogen by the tumor     cells. It is not yet known whether temsirolimus is more effective when given alone or     together with megestrol acetate and tamoxifen citrate in treating endometrial cancer.   "
219765|NCT00729599|"     To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to     odontological usage.   "
219766|NCT00729612|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation and carboplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle     formulation given together with carboplatin works in treating patients with stage IIIB, stage     IV, or recurrent non-small cell lung cancer.   "
219767|NCT00729625|"     Many patients who have sustained strokes are unable to effectively use their hemiparetic     upper extremity. Limited mobility in the performance of daily activities, such as eating or     dressing, adversely affects their quality of life and compromises independence.     Rehabilitation techniques engaging the hemiparetic limb in repetitive task practice (RTP) may     improve upper extremity function and quality of life in patients with stroke, but costs limit     the number of patients that can utilize this type of therapy. Advances in microprocessor     design and function make the use of an assistive device as an adjunct to RTP plausible. An     innovative assistive repetitive motion (ARM) device using an air muscle has been developed     specifically for the rehabilitation of the hemiparetic upper extremity. The primary aim of     the proposed study is to collect pilot data to estimate the clinical effectiveness of using     the ARM device in conjunction with RTP to improve upper extremity motor function and the     quality of life of patients with stroke. Twenty sub-acute (3 to 9 mos. post-stoke) patients     will be randomized to a RTP only or ARM + RTP group. The RTP group will receive 15 days (4     hours per day) of intensive one-on-one RTP therapy. The ARM + RTP group will use the ARM     device for 2 hours per day and receive 2 hours of intensive RTP per day for 15 days. Clinical     motor function and quality of life measures will be taken before and after the interventions     and two months later. We hypothesize that the ARM + RTP group will exhibit greater     improvements in motor function and quality of life measures than the RTP only group.   "
219768|NCT00729638|"     The purpose of this research study is to determine the highest dose of lenalidomide and     RAD001 that can be given without causing too many serious side effects. Another goal of this     research study is to look at how the participants cancer may respond to the study treatment.     Additionally, we wish to learn more about how the body breaks down and gets rid of the study     drugs. We will also try to find substances in the blood (biomarkers) that may help predict     how myeloma will respond to study treatment.   "
219769|NCT00729651|"     To demonstrate the efficacy/safety of Fosamax Plus D   "
219770|NCT00729664|"     Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of     PD-L1 receptor occupancy in peripheral blood has been added.   "
219772|NCT00729690|"     This study involves research. Pregabalin is a Food and Drug Administration (FDA) medication     approved in the United States for the treatment of nerve pain related to diabetes and     post-herpetic neuralgia shingles, and for seizures in adults. The purpose of this research     is to study the effect of oral Pregabalin on spinal neurotransmitters in subjects undergoing     Total Knee Replacement Surgery (TKA). TKA is associated with considerable postoperative pain     which if unrelieved may result in prolonged hospital stay, inability to participate in     rehabilitation programs, poor outcomes, and greater use of health-care resources. This study     examines the effect of pregabalin administered for TKA on pain-related neurotransmitter     concentrations.   "
219773|NCT00729703|"     This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular     stimulation in combination with advanced dual chamber detection with slow VT management on     the clinical outcome for hospitalization and mortality and inadequate therapy in medically     stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do     not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It     compares a new pacing mode avoiding ventricular stimulation when not needed combined with     dual chamber detection with a pure ventricular back up pacing and single chamber detection     criteria with pure ventricular back up pacing. Therapies are compared in a prospective,     randomized, single-blinded, parallel trial with a 24-month randomized treatment period.     Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the     study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.   "
219774|NCT00729716|"     BioCart™II is a novel scaffold seeded with autologous chondrocytes to be used to repair     cartilage lesions of the knee. This study is designed to compare the efficacy and safety of     BioCart™II treatment compared to microfracture which is the classical method of treatment.   "
219775|NCT00729729|"     A comparative bioavailability study of PCA slow release versus immediate release     formulations, after a single dose to fasting healthy subjects.   "
219777|NCT00729755|"     Given 1) the established safety with short-term or long-term supplementation of Cr, 2) its     potential usefulness in improving brain energy metabolism, 3) the reported abnormality in     brain energy metabolism in MDD subjects, and 4) plausible association between depression and     inflammatory mediators, we hypothesize that oral Cr augmentation will help reduce symptoms in     MDD patients as well as normalize a deficit in brain energy metabolism and that improvement     of MDD and brain energy metabolism will be correlated with inflammatory mediators changes.      In this study, we plan to conduct an randomized, double-blind, placebo-controlled     augmentation study with creatine in addition to escitalopram. We will assess the efficacy and     safety of the Cr augmentation and evaluate changes relevant to brain energy metabolism and     inflammatory mediators.   "
219778|NCT00729768|"     This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to     evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both     are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction     therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A     total of 200 subjects undergoing either living or cadaveric renal transplantation will be     randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF +     corticosteroids.   "
219779|NCT00729781|"     The purpose of this study is to research a polyester polyethylene terephthalate (PET) implant     for the treatment of external nasal valve collapse (NVC). NVC is a condition which causes     narrowness and weakness in the nostril which results in nasal obstruction. Implants will be     placed in the affected nostril(s). The implants are intended to restore the shape and     stabilize the nasal wall to prevent nasal valve collapse and improve the symptoms associated     with nasal obstruction.   "
219780|NCT00729794|"     The simultaneous activation of adrenergic and vasopressin receptors, in conjunction with a     potential steroid-mediated enhancement of the vascular reactivity to epinephrine may have     beneficial effects in patients with cardiac arrest. This hypothesis is supported by the     single-center results of NCT 00411879. The investigators intend to either refute or provide     definitive evidence supporting this hypothesis (and its generalizability) by conducting the     present multicenter, randomized, controlled clinical trial of in hospital cardiac arrest.   "
219781|NCT00729807|"     RATIONALE: Drugs used in chemotherapy, such as pentamidine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well pentamidine works in treating patients with     relapsed or refractory melanoma.   "
219782|NCT00721240|"     The main aim of the study is to develop a method that allows responders to be distinguished     from non-responders before long-term treatment is initiated. Subsidiary aims are to record     changes in pulmonary functional parameters, NO concentrations and peak flow variability, the     use of beta2 sympathomimetics and the asthma symptom score.   "
219783|NCT00721253|"     This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to     subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA     IOL   "
219784|NCT00721266|"     This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-tumor activity     of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid     tumors. In the first part of the study, groups of patients will be sequentially enrolled to     receive ascending doses of RO5083945 administered weekly, every 2 weeks or every 3 weeks. The     starting dose of 50mg weekly will be escalated in subsequent groups of patients after a     successful assessment of the safety, tolerability and pharmacokinetics of the previous dose.     In Part 2 of the study, patients with EGFR+ and mutant KRAS colorectal cancer will be     enrolled, and will receive RO5083945 at the recommended dose and regimen identified in Part     1. The anticipated time on study treatment is until disease progression, and the target     sample size is <100 individuals.   "
219785|NCT00721279|"     The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment     effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International     Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time     to reaching maintenance dose of pramipexole   "
219799|NCT00721474|"     A Study to determine if a high-fat meal has an effect on the pharmacokinetics of bosutinib.   "
219787|NCT00721318|"     The chronic widespread pain (CWP) and fibromyalgia (FM) cause serious discomfort, but at the     same time they are not life threatening and they cannot be detected by any laboratory tests.     The problems connected with these conditions have gained little attention in Estonia so far.     It can be assumed that the CWP and FM often remain undetected and the sufferers live without     treatment they need.      So far, there are no data on the prevalence of the CWP and FM in Estonia available.      The goal of the current research is to assess the prevalence of the CWP and local pain     syndromes among Estonia's RA patients and among the control population in Tallinn and Harju     County; also the factors connected with the presence of the pain and the pain treatment in     use.      At the same time there will be a similarly designed research conducted in Jyväskylä Central     Hospital, which provides the opportunity to compare results in Estonia's and Finland's     research groups. The study on the distribution of the chronic pain among RA patients and     control population will allow to assess the magnitude of the problem in Estonia and to raise     the awareness of physicians about CWP and significance of its treatment.      Performing the study will provide an experience which forms the base for further     epidemiological and clinical research on CWP and FM   "
219788|NCT00721331|"     This will be a phase I, single center, randomized, vehicle-controlled, blinded study     comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1%     mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy     volunteers.   "
219789|NCT00721344|"     48 healthy adult male & female subjects will be enrolled in this study to determine the     effect of Technosphere® Inhalation Powder (FDKP) on the QT interval of the EKG. Eligible     subjects will be randomized into a dosing regimen after admission.   "
219821|NCT00721760|"     The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.]     injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the     prevention of Venous Thromboembolic Events [VTE] in patients undergoing hip fracture surgery.      The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing hip     fracture surgery, and to document AVE5026 exposure in this population.   "
219790|NCT00721357|"     Of the ~700,000 persons who suffer a stroke each year, only 50% recover the ability to     perform unlimited community walking. One mechanism contributing to locomotor dysfunction     post-stroke is an increased metabolic cost of walking relative to neurologically healthy     individuals 2-4. This increased cost likely limits the amount of walking performed, which     further reduces functional capacity, thus contributing to long-term spiral of disability and     decreased quality of life in these persons. In addition to increased metabolic cost,     increased estimates of mechanical work are also characteristic of hemiparetic walking 2,29.     Interestingly, although estimates of mechanical work reflect work done by locomotor muscles,     little is known about the impact that peripheral muscle properties have on estimates of     mechanical work. Furthermore, questions concerning how these properties relate to the     increased metabolic cost of walking remain unanswered. The short-term objective and purpose     of the proposed research is to determine the extent to which peripheral muscle     characteristics, as well as estimates of muscle mechanical energy expenditure (MMEE), relate     to the metabolic cost of walking post-stroke.   "
219791|NCT00721370|"     Sentinel lymph node (SLN) mapping is the standard of care for the surgical staging of breast     cancer. We propose a method of SLN mapping based on the use of invisible near-infrared     fluorescent light that has significant advantages for both patient and surgeon. The present     study is a 6-patient pilot study designed to optimize clinical workflow with the new imaging     system.   "
219792|NCT00721383|"     The purpose of this randomized clinical trial is to test a 12-month multi-component health     promotion intervention with home-based family caregivers of persons with Alzheimer's Disease     and other related dementias. Specific aims are to: 1) Test the primary hypothesis: The     Enhancing Physical Activity treatment intervention will be more effective in increasing     caregiver lifestyle physical activity than the Standard Care Intervention; 2) Test secondary     hypotheses: The Enhancing Physical Activity treatment intervention will be more effective     than the Standard Care Intervention in improving the following caregiver secondary outcomes:     mental health, physical health and physical function; and 3) Evaluate the process of     implementing a lifestyle physical activity intervention with family caregivers. The Standard     Care Intervention focuses on well-established care-related education and support needs. The     Enhancing Physical Activity treatment intervention focuses on two areas: increasing lifestyle     physical activity and addressing well-established care-related concerns that are likely to     interfere with increasing physical activity. A total of 190 middle-age to older     community-based primary caregivers of persons with Alzheimer's disease or other related     dementias who report some to moderate strain with caregiving activities will be randomly     assigned to either the Enhancing Physical Activity or Standard Care Intervention. Data will     be collected at baseline, 3, 6, 9, 12 and 18 months and include self-report and direct     observational methods. Data will be analyzed by using repeated measures models using the     generalized estimating equation approach. Family caregivers are a stressed population who     experience changes in their mental and physical health. However, effect sizes have been     minimal for interventions designed to only affect caregiver mental health. No study known to     us, has tested the added value of physical activity adoption in conjunction with more     traditional caregiver support and skill building. Study findings will enable us to evaluate     the behavioral , physical, and health-related quality of life effects achieved by the     combined intervention; and will add knowledge about the most effective ways of intervening     with family caregivers and other chronically stressed middle-age and older adult populations.   "
219793|NCT00721396|"     Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given     concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4     months of age, as measured by percentage of subjects with serum bactericidal activity (SBA)     titer ≥1:5, at 1 month after the third vaccination Secondary :To demonstrate that     immunogenicity of routine infant vaccines, when given concomitantly with rMenB+OMV NZ to     healthy infants at 2, 3 and 4 months of age, was non-inferior to that of routine infant     vaccines given without rMenB+OMV NZ. 2. To demonstrate that the immunogenicity of rMenB+OMV     NZ when given concomitantly with routine infant vaccines was non-inferior to that of     rMenB+OMV NZ given without routine infant vaccines at 2, 4 and 6 months of age. 3. To assess     prevalence of meningococcal B antibodies over the study period by evaluation of SBA, at     baseline and at 1 month after third vaccination, in subjects- received routine infant vaccine     without rMenB+OMV NZ.   "
219794|NCT00721409|"     The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess     the effect of the combination on advanced breast cancer   "
219795|NCT00721422|"     1. To investigate the effect of kidney function on the elimination of a single dose of PD          0332334 from the body.        2. To investigate the safety and tolerability of a single dose of PD 0332334 in patients          with impaired kidney function.   "
219796|NCT00721435|"     The study will evaluate and refine a breast screening and diagnosis device.   "
219797|NCT00721448|"     This will be a single centre study conducted at the 3rd hospital affiliated to Peking     University. Approximately 24 healthy Chinese volunteers, male and female, will be recruited     to obtain at least 20 evaluable volunteers. The primary objective of this study is to     characterize the pharmacokinetics of AZD6140 and its active metabolite AR-C124910XX after     single and multiple (twice daily) doses of AZD6140 90 mg and 180 mg in healthy Chinese     volunteers. The secondary objective of this study is to determine the safety and tolerability     of single and multiple (twice daily) 90 mg and 180 mg doses of AZD6140 by physical     examination, clinical laboratory tests, vital signs, and collection of adverse events in     healthy Chinese volunteers.   "
219800|NCT00721487|"     The primary aims of this study are to identify and characterize the immediate consequences of     patients who fail fluconazole treatment during the treatment of severe infection, and to     determine if fluconazole failures are more frequently associated with fluconazole-resistant     or fluconazole-susceptible strains of C. albicans.   "
219801|NCT00721500|"     This study seeks to evaluate the clinical fitting performance of a new daily disposable     contact lens to an existing daily disposable contact lens.   "
219802|NCT00721513|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy     uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with     cetuximab and radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and     fluorouracil together with cetuximab and radiation therapy works in treating patients with     locally advanced head and neck cancer.   "
219818|NCT00721721|"     High blood pressure is a serious health problem. In terms of diet recommendations, people     with this condition are encouraged to eat a low sodium and high potassium diet. It is     believed that genetics may play a role in the development of high blood pressure and may     affect changes in blood pressure levels, including changes brought on by sodium and     potassium. This study will identify genetic factors that may influence blood pressure changes     due to increased salt or potassium intake in people with mildly elevated blood pressure and     in their family members.   "
219803|NCT00721526|"     The proposed design is a single-group open-label trial. Qualified consenting participants     with active alcohol dependence and primary or secondary anxiety disorder will receive     monitored disulfiram and lorazepam, in the context of a structured Medication Management (MM)     model. In weeks 9-15 lorazepam is tapered, and disulfiram is stopped at the end of week 16.     Participants who achieve 4 weeks abstinence and meet criteria for a primary anxiety disorder     or mood disorder may receive ancillary medication consisting FDA-approved non-benzodiazepine     treatment, with specific options for each disorder described in the protocol. Participants     requiring continued treatment are referred to clinical treatment in the community at week 16,     and bridging prescriptions of anxiolytic/antidepressant medication may be provided. A final     follow-up assessment occurs at week 28. The primary outcomes are Percent Days Abstinent (PDA)     and retention in treatment. Secondary alcohol outcomes are consequences, drinks per drinking     day, remission status, and time to first heavy drinking day. Anxiety outcomes are Hamilton     Anxiety Scale scores and anxiety disorder diagnosis.   "
219804|NCT00721539|"     To assess the use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc.,     Sunnyvale, CA) in transoral surgeries in patients with benign and malignant lesions of the     oral cavity and laryngopharynx.   "
219805|NCT00721552|"     The investigators will assess whether the DPP-inhibitor sitagliptin will ameliorate     glucocorticoid-induced impairment of glucose metabolism and beta-cell dysfunction and thus     could be used as a prophylaxis for glucocorticoid-induced diabetes. Therefore the     investigators will administer in males with the metabolic syndrome 30 mg prednisolone daily     for two weeks and give simultaneously sitagliptin 100 mg daily. Subjects will undergo at     baseline and after two weeks of treatment several tests to assess changes in glucose     metabolism.   "
219806|NCT00721565|"     Translation of the current basic science information related to physical activity into     patient intervention programs is needed. This translation is critical to providing benefit to     the maximum number of patients. Little is known about the determinants of physical activity     among breast cancer patients undergoing hormonal therapy and few studies have attempted to     evaluate an exercise behavior change program aimed to improve exercise adherence among such     patients. The proposed project will evaluate use of an innovative behavioral and psychosocial     intervention to increase physical activity among breast cancer patients.   "
219807|NCT00721578|"     To collect and summarize information on the diagnosis, management, and clinical and     mycological outcomes of patients with systemic fungal infections in order to better     understand the effectiveness of antifungals in the treatment of Systemic Fungal Infections     (SFI) in India.   "
219808|NCT00721591|"     To determine, through pharmacokinetic parameters, the ideal dosing protocol for dalteparin (a     low molecular weight heparin) and unfractionated heparin for women desiring pregnancy who     have evidence of an acquired (specifically, antiphospholipid syndrome) or inherited     thrombophilia.   "
219809|NCT00721604|"     The purpose of this study is to verify the accuracy and applicability of predictors of fluid     administration efficacy in hypotensive critically ill patients.   "
219810|NCT00721617|"     Although a large number of obese patients develop high blood pressure, the cause is unknown.     The purpose of this study is to look at the effect of high fatty acids (a type of fat) in the     development of high blood pressure in obese people.   "
219811|NCT00721630|"     HER2 is a protein that sits on the surface of breast cancer cells in some people. Because you     are one of these people, your breast cancer is called HER2-positive. The HER2 protein is     involved in the growth of your breast cancer. Certain drugs can interfere with the ability of     the HER2 protein to cause breast cancer growth. Trastuzumab is one of these drugs. You must     have already received trastuzumab as treatment for your breast cancer to be considered for     this study.      Other drugs are being studied in women with HER2-positive breast cancer. Lapatinib (Tykerb™)     blocks signals that stimulate HER2-positive breast cancers to grow. The FDA approved     lapatinib for use with capecitabine (Xeloda™) in patients who have metastatic breast cancer     that has grown or spread after treatment with trastuzumab.      Capecitabine was approved by the FDA in 1998 for treating metastatic breast cancer.     Capecitabine is a pill that blocks the way cancer cells multiply and grow. Usually, this     medicine is taken twice a day for fourteen days. Then, patients do not take the pill for     seven days. With this schedule and dose, some patients have had side effects that interfered     with their comfort. We have used mathematical models to recommend a new schedule of     capecitabine. In animals, 7 days of treatment with capecitabine followed by a 7-day break was     safer and more active against breast cancer. The purpose of this study is to find out what     effect (both good and bad) capecitabine has on you and your breast cancer when given in this     new schedule and combined with lapatinib.   "
219812|NCT00721643|"     The absorption kinetics of polyphenols in angel's plant (Angelica keiskei), which is a dark     green leafy vegetable rich in antioxidant nutrients, will be determined in older adults in     this pilot study.   "
219813|NCT00721656|"     To evaluate the efficacy and safety of KLS-0611 compared to placebo in patients with dry eye     syndromes.   "
219814|NCT00721669|"     Primary objective is to evaluate the safety and PK of IMGN388   "
219815|NCT00721682|"     The hypothesis of this study is nonrecognition by the medical team of pain in maltreated     children. These children would have a particular painful behaviour, quiet. The management     of their pain would be then unsuited, which could explain their complex relation with the     pain in the adulthood. A pilot study realized in the CHU of Nantes on 11 files of maltreated     children showed that they had very low scores of evaluation of the pain, in spite of severe     traumatisms. There is, at the moment, no data in the literature on the acute pain of the     maltreated children.   "
219816|NCT00721695|"     This is an exploratory study to determine the safety and clinical benefit of OMS302 Injection     in subjects undergoing Cataract Extraction with Lens Replacement (CELR) using a coaxial     phacoemulsification process.   "
219817|NCT00721708|"     The absorption kinetics of dietary carnosine (β-alanyl-L-histidine) will be determined in the     healthy adults.   "
219819|NCT00721734|"     The purpose of this study is to assess the influence of renal impairment on carfilzomib in     patients with Multiple Myeloma (MM).   "
219820|NCT00721747|"     The purpose of this study is to determine how many pathological complete responses are     achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide     (MC) first line treatment in HER2 negative brest cancer patients.   "
219824|NCT00721799|"     This is an imaging protocol only, not a therapeutic study.      The primary goal of the proposed study is to examine the utility of a new imaging study,     Positron Emission Tomography with F-18 Fluorothymidine (FLT PET), in the early treatment     evaluation of head and neck cancer. FLT uptake in the tumor correlates with the rate of cell     proliferation. It is therefore hoped that changes in tumor FLT uptake after therapy will     reflect change in the number of actively dividing tumor cells and will provide early     assessment of treatment response.      Research subjects will undergo one PET scan with FLT. The scan is done prior to any     therapeutic intervention (radiation or chemotherapy) can be obtained up to 30 days prior to     the start of therapy. The uptake of FLT in the tumor will be analyzed to see if it can be     used as a predictor of treatment efficacy and/or outcome.      There is an optional biopsy component to this study. Should the attending physicians     (primarily the otolaryngologists) believe that the subject can safely undergo an outpatient     biopsy, and the subject agrees, a biopsy is performed. The biopsy will be done within 30 days     prior to treatment, similar to FLT PET scans. Tissue from the biopsy will be analyzed for     markers of cellular proliferation and these markers will be correlated with the findings of     FLT PET scan.      There will be a 2-year clinical follow-up to assess for treatment outcomes, local control,     and overall survival.   "
219825|NCT00721812|"     A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of     GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers   "
219826|NCT00721825|"     TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in     post-stroke recovery, and to assess the utility of the rehabilitation outcome measure     instruments used.   "
219827|NCT00721838|"     to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery   "
219828|NCT00721851|"     The primary aim of this study is to determine the potential utility of 320-slice volume-CT     for obtaining adequate diagnostic accuracy while at the same time improving image quality     compared with previous generations of CT scanners and simultaneously enabling a reduction in     both radiation exposure and contrast agent amount required.   "
219829|NCT00721864|"     This study is designed to better understand the molecular biology of paroxysmal nocturnal     hemoglobinuria (PNH) and to determine if prion protein (PrP) functions in long term     hematopoietic stem cell renewal.   "
219830|NCT00721877|"     Resveratrol may prevent cancer in healthy people. Studying samples of blood and urine in the     laboratory from participants who are taking resveratrol may help doctors learn more about how     this drug is used by the body. This phase I trial is studying the side effects of resveratrol     and to see how it works in healthy adult participants.   "
219860|NCT00722280|"     Overall Goal      To establish hand transplantation as a safe and effective reconstructive strategy for the     treatment of upper extremity amputations.      Specific Aim      To reduce the risk of rejection and enable allograft survival while minimizing the     requirement for long term high dose immunosuppression.      For this purpose, we propose to utilize the Pittsburgh Protocol, which is an     immunomodulatory strategy that has been implemented in solid organ transplants at UPMC. Early     results in living related liver and kidney patients have confirmed that this protocol     provides the means to allow graft survival with minimization of maintenance immunosuppression     and even allows weaning of some patients from long-term immunosuppression.We hypothesize that     a similar protocol can enable graft survival in highly immunogenic composite tissue     allografts like hand transplants while reducing the number,dosing and/or frequency of     immunosuppressive drugs associated with serious adverse effects.   "
219831|NCT00721890|"     Green tea is extracted from steam treated leaves, allowing the preservation of catechins, the     active elements of the infusion. Catechins are recognized for their anti-cancer activity.     Catechins act on the capacity of cancer to disseminate to other organs because of their     anti-protease action. Proteases are proteins capable of digesting the cancer environment and     facilitating the progression of cancer cells to blood vessels which will bring them to     distant organs. We know that ovarian cancer responds well to the initial treatment of     chemotherapy but tends to recur rapidly. We intend to provide green tea with higher     concentrations of catechins to women with complete remission of their ovarian cancer in an     attempt to delay cancer relapse. We also intend to identify, with molecular technologies, the     proteases involved in ovarian cancer recurrence and response to catechins. Our objective is     to test the hypothesis that green tea intake may delay ovarian cancer recurrence and to     develop tools to predict which women will best benefit of the addition of green tea to their     initial treatment.   "
219832|NCT00721903|"     The purpose of this study is to determine how well changes can be determined in malignant     masses from ultrasound scans.   "
219833|NCT00721916|"     This is a randomized, multicenter study designed to evaluate the progression free survival of     the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV     and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.   "
219834|NCT00721929|"     The purpose of this study is to determine if certain MRI sequences can accurately diagnose     adrenal masses of unknown origin.   "
219835|NCT00721955|"     Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in     bipolar 1 disorder patients.   "
219836|NCT00721968|"     To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400     in conjunction with cataract surgery, compared to cataract surgery only, in subjects with     mild to moderate open angle glaucoma.   "
219837|NCT00721981|"     The main purpose of this study is the identification, description, and segmentation of     non-small cell lung cancer (NSCLC) patients based on their value appraisal of treatment     outcomes and all intermediate states of health, to obtain patient preferences in direct     correlation with clinical data from patients suffering from NSCLC (stage IIIB / IV) who are     in transition from 1st to 2nd line treatment, and to gain utility scores by health state     derived from patients' perceived value and taken from their perspective.   "
219838|NCT00721994|"     primary endpoint of this Study is maintenance of at least good clinical status for a period     of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market     IDE.   "
219839|NCT00722007|"     The primary objective of this study is to evaluate the performance of the Cormet Hip     Resurfacing implant system in the post-approval environment.   "
219841|NCT00722033|"     Very low birth weight infants has increased dramatically their survival. Survival without     neurologic disturbance varies a lot between centers.There is evidence that fluctuations in     cerebral blood flow influences the appearance of intraventricular hemorrhage and itself     implies a detrimental neurologic developing.The electroencephalography is the result of     electric base membrane activity on rest, and it's influenced by the blood flow either. The     Amplitude-integrated electroencephalography is a novel tool, that is capable to be     continuously used at the patient bed and is easily to be read by the trained clinician.The     hypothesis is that common procedures as Surfactant instilation, Indomethacin and Aminophyline     infusion as the appearance of apneas alters the aEEG register. It is a prospective study that     tries to recruit 10 < 30 weeks of gestational age with aprofen consent to monitorize the aEEG     since birth to the seventh day of live.   "
219842|NCT00722046|"     Purpose of the study is to determine whether multiple dose administration of PF-04360365 is     safe and well tolerated in patient with mild to moderate Alzheimer's disease.   "
219843|NCT00722059|"     The purpose of this study is to compare 3D mammography with digital mammography in women with     dense breasts for the detection and evaluation of masses and/or breast cancer.   "
219844|NCT00722072|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Estrogen can cause the growth     of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking     the use of estrogen by the tumor cells. Giving sorafenib together with fulvestrant may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving sorafenib together with fulvestrant     works in treating patients with locally advanced or metastatic breast cancer that did not     respond to aromatase inhibitor therapy.   "
219845|NCT00722085|"     Amniotic Fluid Sludge Does Not Increase Risk of Preterm Delivery in Cerclage Patients.   "
219846|NCT00722098|"     The purpose of this study is to determine whether the combination of chemotherapy     (Cyclophosphamide) and CD34-DC vaccines results in the improved rate of clinical responses     for stage IV melanoma patients.   "
219847|NCT00722111|"     The purpose of this study is to determine whether stroke patients with swallowing problems     will show greater swallowing improvement with intense oral exercise than subjects who perform     either a low intensity oral exercise or a sham exercise.   "
219861|NCT00722293|"     This is an open-label, four-arm, Phase I, dose escalation study to evaluate the safety and     tolerability and to determine the optimal tolerated regimen (OTR) of pazopanib in combination     with epirubicin or doxorubicin in patients with advanced solid tumors. Patients will be     enrolled in cohorts of 3 to receive escalating doses of pazopanib and epirubicin or     doxorubicin. Dose escalation schemas for each study arm are described in the protocol. For     each arm, the OTR will be defined as the highest dose combination of the agents where no more     than one out of six patients experiences a dose-limiting toxicity. Twelve additional patients     in each arm will be studied with the OTR to evaluate toxicity and pharmacokinetics. This will     allow an assessment of potential drug-drug interactions. Antitumor activity will be assessed     using RECIST criteria.   "
219862|NCT00722306|"     To determine the mass balance of PD 0200390   "
222898|NCT00770510|"     The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in     Japanese participants with primary insomnia.   "
219848|NCT00722124|"     Cigarette smoking is of great public health importance and is the single most important     preventable cause of morbidity, mortality and excess health care costs in the United States.     After a steady decline for the last 50 years, the prevalence of tobacco use in the United     States has reached a plateau of approximately 21%. Currently available treatments among     adults are not efficacious for all tobacco users. New pharmacologic agents thus need to be     continually developed and tested.      The release of dopamine in the nucleus accumbens is one of the key components of the     pleasurable and rewarding effects of nicotine. Drugs that increase monoamine neurotransmitter     availability (particularly dopamine and norepinephrine) are likely to increase the reward     function and thus ameliorate withdrawal symptoms. S-Adenosyl-L-Methionine (SAMe), the primary     methyl donor for the central nervous system (CNS), donates methyl groups towards presynaptic     synthesis of CNS monoamine neurotransmitters. By facilitating the synthesis of dopamine and     norepinephrine in the brain, SAMe is likely to ameliorate the symptoms of nicotine     withdrawal, thus improving tobacco abstinence rates in smokers who are trying to stop     smoking. SAMe is well tolerated and is available over-the-counter.      To date, no prospective clinical trial evaluating the efficacy of SAMe for the treatment of     tobacco dependence has been published. We propose to evaluate the efficacy of SAMe for     increasing smoking abstinence and decreasing nicotine withdrawal symptoms in a randomized,     blinded, placebo-controlled, three-arm, parallel-group, dose-ranging phase II clinical trial.     Participants (N=120) will be randomly assigned to one of the three groups, and will receive     an 8-week course of SAMe 800-mg per day, 1600-mg per day, or a matching placebo. This study     is anticipated to provide the data needed to develop a larger randomized controlled clinical     trial submitted through the R01 funding mechanism, if the results appear promising.   "
219849|NCT00722137|"     This is a randomized, open-label, multicentre, prospective study to compare the efficacy and     safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly     diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone     marrow transplantation.   "
219850|NCT00722150|"     The purpose of this study is to determine the impact of varying doses of artesunate on     treatment outcome and whether higher doses of artesunate can overcome the problem of     compromised artemisinin sensitivity in the region.      To determine the safety and tolerability of this previously untested experimental high dose     (6 mg/Kg/D X 7 day, total 42 mg/Kg) artesunate monotherapy regimen.   "
219851|NCT00722163|"     In the first year of treatment after a FE of SCZ, 75% to 90% of patients achieve remission     from psychotic symptoms. However, approximately 40% of FE patients are non-adherent to     medication regimes and more than 60% have intermittent periods of gaps of non-adherence.     Relapse rates are high with 82% of patients relapsing at least once within 5 years.     Unfortunately even amongst those who do achieve full remission from psychotic symptoms,     functional recovery remains a major challenge for patients. All the evidence suggests that     individuals with SCZ do best with a combination of pharmacology and psychosocial     intervention. Cognitive-behavior therapy (CBT) is gaining recognition as an effective     treatment in SCZ and is in fact the only psychosocial treatment in SCZ with proven durability     at short term follow-up. Although it is currently being used, the investigators need to learn     more about the impact of CBT on FE SCZ especially as experts are advocating for CBT to be a     critical component of FE clinical services.   "
219936|NCT00731991|"     The general purpose of this research project is to use surface electromyography to compare     the effect of Active Release Technique versus Proprioceptive Neuromuscular Facilitation on     the electrical activity of the upper trapezius muscle at rest and during contraction.   "
219852|NCT00722176|"     A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The     Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To     Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum     Of Six Weeks With Bl-1020 (High Dose, Low Dose), Risperidone Or Placebo   "
219853|NCT00722189|"     An assessment of the efficacy and safety of Travogen cream and Travocort cream in the     treatment of local skin mycoses   "
219854|NCT00722202|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV     administered ERB-257 as single ascending doses to healthy Japanese male subjects   "
219855|NCT00722215|"     The number of people with kidney problems is increasing rapidly, related in part to the     increasing prevalence of diabetes. Patients with kidney problems tend to have protein leaking     into the urine (proteinuria). Both proteinuria and the kidney disease itself are associated     with an increased risk of heart disease. Reducing proteinuria is an important treatment goal     in people with kidney problems. Endothelin is a chemical produced both by blood vessels and     the kidney. Higher than normal levels of endothelin are thought to contribute to progression     of kidney disease and proteinuria. By using drugs that block the effects of endothelin     ('endothelin receptor antagonists') we can hopefully reduce both of these. The purpose of the     study is to ascertain whether endothelin receptor antagonists improve kidney function and     reduce proteinuria more so than other commonly used drugs.   "
219856|NCT00722228|"     This study is based on the finding that tumor cells that are grown in the laboratory can be     modified in such a way that, when injected to the patient, they will stimulate his/her immune     response. This approach will be evaluated in patients with colorectal, gastric, ovarian,     breast or lung epithelial cancer. Tumor cells grown in the laboratory will be modified to     make them stimulatory to the immune system, irradiated to kill them, and injected to the     patient eight times at two-week intervals . This protocol is expected to prolong survival of     metastatic epithelial cancer patients.   "
219857|NCT00722241|"     The purpose of this study is to evaluate the safety and effectiveness of the next-generation     DexCom SEVEN Continuous Glucose Monitoring System (SEVEN.2 System) when worn for up to 7-days     by subjects >18 years-old with diabetes mellitus requiring insulin therapy.   "
219858|NCT00722254|"     To determine the prevalence of myelofibrosis in patients with primary pulmonary hypertension,     and to discover if the fibrosis in these patients is primary (AMM) or secondary.   "
219859|NCT00722267|"     This study is investigating how patients with severe stable state COPD perceive the     variability of their symptoms throughout the day, the week and the year; the impact of these     variations on their daily activities or sleep quality and how they deal with their     treatments. For this purpose patients will be asked to answer a questionnaire over the phone   "
219878|NCT00722527|"     Our study is designed to characterize the clinical picture and genetic pattern of     Polycythemia and Thrombocytosis. The purpose of this project is to find a gene and its     mutation that causes these disorders. When this is accomplished, new therapies to control and     eventually cure the disorder can be designed.   "
219879|NCT00722540|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male     Japanese subjects.   "
219905|NCT00730145|"     1. Quantify how much PD-0332334 is removed from the blood with hemodialysis        2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving          regular hemodialysis treatments.        3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects          receiving hemodialysis.   "
219863|NCT00722319|"     Patients on warfarin treatment pose particular problems when undergoing percutaneous coronary     intervention with stent implantation (PCI-S), because of the poor definition of the optimal     antithrombotic strategies to be adopted both peri-procedurally and during the 4 (or more)     weeks after PCI-S, when dual antiplatelet therapy with aspirin and clopidogrel is     recommended. In the absence of solid evidence-based data, no definite recommendations for the     management of this patient subset are currently given in the guidelines on percutaneous     coronary intervention issued by the most prominent Cardiology Associations. Indeed, a high     variability has been reported in the current antithrombotic strategies, which may consist in     either the temporary substitution of warfarin by dual antiplatelet treatment or the     combination of warfarin and aspirin or clopidogrel or both. Peri-procedural bridging therapy     with either intravenous unfractionated or subcutaneous low-molecular-weight heparin is also     variably carried out. Purpose of this registry is to determine in patients on warfarin     treatment undergoing PCI-S: 1) the contemporary peri-procedural and medium-term     antithrombotic management; and 2) the relative safety and efficacy of the various     antithrombotic regimens.   "
219864|NCT00722332|"     The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B     in combination with antiviral therapy for the prevention of hepatitis B virus (HBV)     recurrence following HBV-related orthotopic liver transplant.   "
219865|NCT00722345|"     Exercise consultation, an intervention approach based on the transtheoretical model has been     successful in promoting physical activity (PA) among adults. It is unknown whether this     approach would be efficacious with youth. The purpose of this pilot study was to assess     whether exercise consultation would increase PA levels and improve anthropometric measures     and metabolic markers in obese adolescents.   "
219866|NCT00722358|"     The primary purpose of this study is to assess the change in HCV RNA during dosing with     BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection   "
219867|NCT00722371|"     A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration     in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.   "
219868|NCT00722384|"     To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal     injection in patients with wet age-related macular degeneration.   "
219910|NCT00731653|"     The objective of this study is to allow patients who have participated in the precursor study     of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01)     to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination     with an increased dose of BCI-049.      The safety and tolerability of this higher dose of the combination will be evaluated, as will     the treatment effect in reducing symptoms of depression in patients with MDD.   "
219869|NCT00722397|"     The TODAY study group has prepared a protocol with the primary objective of collecting blood     and phenotypic information to be used to explore relationships between candidate genes and     type 2 diabetes (T2D), as well as obesity, insulin resistance, and cardiovascular     complications of insulin resistance. Participation in the genetics study includes a blood     draw for analysis of diabetes type and DNA extraction, as well as collection of basic family     and medical history. Appropriate informed consent and assent are obtained from all     participants to extract DNA and send blood, genetic material, and medical history to the     Central Repository of the National Institute of Diabetes and Digestive and Kidney Diseases     (NIDDK) of the National Institutes of Health (NIH). The data are kept indefinitely by the     Central Repository. The NIDDK will issue requests for proposals (RFP) throughout the     scientific community for research that may help in the development of new diagnostic tests,     new treatments, and new ways to prevent diabetes and other related comorbidities.   "
219870|NCT00722410|"     Infection by Klebsiella pneumonia producing class A carbapenemases is a major clinical and     public health problem in Israel and worldwide. The aim of this study is to determine the     safety and efficacy of alteration of the gut microflora by probiotics, alone or in     combination with mechanical bowel cleansing, as a strategy to eradicate colonization of the     gastrointestinal tract by CRKP. We hypothesize that administration of probiotics will     decrease the rate of GI colonization by CRKP.   "
219871|NCT00722423|"     This is a prospective randomized controlled trial comparing two different clinic models for     patients with hepatitis C. These patients commonly have mental health problems that are     barriers to receiving HCV treatment. Patients giving informed consent will be randomized to a     usual care HCV clinic vs. a HCV clinic with the addition of an on-site mental health     practitioner who will address psychiatric and substance use issues with the goal of enabling     patients to undergo effective antiviral therapy. The major outcome of the study is the number     of patients in each group who are cured with antiviral therapy. Patients in both groups     receive current standard of care.   "
219872|NCT00722436|"     This is a randomized, blinded, prospective study that will investigate the potential benefit     of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric     patients undergoing craniofacial surgeries.   "
219873|NCT00722462|"     The present study is designed to test the hypothesis that acupuncture, before and after     embryo transfer, significantly improves pregnancy rates, compared to embryo transfer with     sham acupuncture and no acupuncture at all.   "
219874|NCT00722475|"     The investigators want to test whether infusions of intravenous immunoglobulin - a blood     product known to modify immune responses - in early pregnancy will increase the chance of a     subsequent live birth in women with three or more miscarriages after a birth and a total of     at least four miscarriages. This will be done in a trial where 82 patients will be randomly     allocated to infusions with intravenous immunoglobulin or placebo during pregnancy.   "
219875|NCT00722488|"     This is an open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult     patients with lymphoma or multiple myeloma. The patient population will consist of adults     with a confirmed diagnosis of lymphoma (Waldenstrom's macroglobulinemia is permitted) or     multiple myeloma that is relapsed and/or refractory after at least 2 prior standard     chemotherapeutic regimens and for which no curative option exists.      Patients in the expansion cohort, Schedule E, must specifically have Hodgkin lymphoma,     DLBCL-GCB subtype, DLBCL-non-GCB subtype, or Mantle Cell Lymphoma (MCL). Patients with     multiple myeloma will no longer be evaluated as a part of this study.   "
219876|NCT00722501|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     ascending single IV doses of ERB-257 in healthy subjects   "
219877|NCT00722514|"     Long term disease management is essential for Ankylosing Spondylitis (AS), a chronic     progressive systemic inflammatory disease of the axial skeleton. Extensive information about     the disease is a necessary first step. An education program for AS was implemented to improve     inpatient medical rehabilitation. In a controlled quasi-experimental multicentric study the     efficacy of this program was analysed.   "
219880|NCT00729820|"     Recently, a lot of evidence for a relation between measures of cognitive performance and     personality characteristics has been collected. The use of computer based latency measures is     often used to study mental processes in cognitive, as well as, in personality research On the     basis of these relationships we can ask a question that relates to the practical usefulness     (validity) of processing speed, accuracy of performance and personality measures in     predicting impulsive behavior.   "
219881|NCT00729833|"     The study is being conducted to determine the maximum tolerated dose, overall safety and     tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in     combination with advanced solid tumors.   "
219882|NCT00729846|"     To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and     the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic     therapy at standard or reduced fluence level in patients with subfoveal CNV due to     age-related macular degeneration.   "
219883|NCT00729859|"     The original purpose of this research study was to understand the effects of testosterone (T)     and estrogen on stem cells in the blood. The knowledge would be used to help understand the     effects of T and estrogen on cardiovascular (heart and blood vessel) disease, and to help in     the development of a safe male hormonal contraceptive.      The effect of androgens on the number of circulating endothelial progenitor (CEP) cells would     best be observed in group 1 (placebo). Upon observation of group 1 under original protocol,     changes in CEP cells were not significant but there were changes in markers of inflammation,     lipids, and HDL protein composition. A modification to the protocol and title were made to     reflect this for groups 2 and 3: Hormonal regulation of HDL-C in Men.   "
219884|NCT00729872|"     The purpose of this study is to verify the safety and tolerability of AG011 (genetically     modified L. lactis that has been engineered to secrete human Interleukin-10), and to     determine whether AG011 can successfully treat the symptoms of moderately active Ulcerative     Colitis (UC).   "
219911|NCT00731666|"     This study is designed to assess the effectiveness of the Coloplast Titan® Inflatable Penile     Prosthesis (IPP) at maintaining or increasing penile length after implantation of the device.     It will incorporate a modified method of cylinder sizing during implantation and a     max-inflate technique after implantation.   "
219885|NCT00729885|"     Benign Paroxysmal Positional Vertigo (BPPV) is one of the most common causes of vertigo and     the most common vestibular disorder of the inner ear. BPPV is the result of small     free-floating particles (canaliths) in the posterior semicircular canals where they aggravate     the sensory apparatus and induce sudden and severe attacks of vertigo when the head is turned     into certain positions.      The treatment of BPPV was revolutionized by the introduction of the Epley maneuver, a     sequence of head movements that use gravity to reposition the canaliths within the inner ear.     The Epley maneuver provides prompt relief from vertigo in approximately 80% of patients.      The innovation, the Vertigone goggle, provides both physician and patient with visual     feedback to guide them through an accurate Epley maneuver. This changes the current treatment     paradigm for BPPV, greatly increasing the availability of the maneuver to non-specialist     physicians, nurse practitioners, physician's assistants and physical therapists. The device     is designed so that the patient with recurrent vertigo can use the goggle to treat BPPV at     home. The goggle is currently a pre-market prototype.      The hypothesis for the study is that accuracy in the performance of the Epley maneuver     correlates with improved clinical resolution of vertigo in BPPV patients. If the hypothesis     is true, then there is a clear case for the utility of the visual feedback provided by the     VertiGONE goggle in performing the maneuver.   "
219886|NCT00729898|"     This study is conducted in Europe. The study aims to observe the incidence of serious adverse     drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.   "
219887|NCT00729911|"     1. To determine if catheter-based atrial fibrillation (AF) ablation is superior to          Amiodarone treatment for symptomatic persistent/permanent AF in ICD/CRTD patients with          an impaired left ventricular function.        2. Hypothesis: AF ablation is better than Amiodarone for subjects with symptomatic          persistent or permanent AF and impaired LV function in terms of recurrence of AF,          quality of life, 6-minute walk distance, EF and total number of hospitalizations.   "
219888|NCT00729924|"     This study is being done to find out how much of the drug raltegravir (RGV) gets into     cerebrospinal fluid (CSF), compared to how much get into the blood and to find out if normal     changes in a certain gene in your body affects how much RGV gets into the CSF.   "
219889|NCT00729937|"     The purpose of this study is to determine the optimal outpatient treatment strategy of     uncomplicated skin and soft tissue infection (SSTI) in areas of the United States where the     prevalence of Community-Acquired Methicillin-Resistant Staphylococcus (S.) aureus (CA-MRSA)     is high. Infection with the S. aureus bacteria that is resistant to antibiotics is a cause of     SSTIs. Three oral antibiotics will be tested for off patent treatment. Patients will receive     Trimethoprim/Sulfamethoxazole (TMP/SMX), placebo (substance containing no medication),     clindamycin, or cephalexin or some combination of these. The study population will include     2,235 volunteers, children 13 years of age and over and adults presenting to 5 large urban     Emergency Departments. Therapy for acute uncomplicated SSTIs, including abscess, infected     wound, and cellulitis will start on the day of enrollment. Participants may be involved in     study related procedures for about 9 weeks.   "
219890|NCT00729950|"     This is a Phase I, open-label, multicenter, pharmacokinetic study of MDX-010 in up to 90     evaluable subjects with surgically unresectable malignant melanoma.   "
219891|NCT00729963|"     The primary objective of this study is to observe if Sibutramine is effective in improving     the symptoms and signs of sleep apnea in obese patients. The secondary objectives are to     document the effects of Sibutramine on heart rate variability and 24-h arterial pressure     values. We hypothesized that sibutramine will improve sleep disordered breathing, cardiac     autonomic function and systemic blood pressure in obese patients with obstructive sleep apnea     (OSA).   "
219892|NCT00729976|"     Fever is one of the most common symptoms in pediatrics and one of the most common reasons for     visits in pediatricians' office and pediatric emergency departments. Many parents consider     fever to be the most terrifying symptom.      Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen     was available only in tablets suspension and as a liquid gel. All these dosage form are     administered orally. Rectal suppositories are often essential for treating febrile children     who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare     the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.   "
222899|NCT00770523|"     Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning     for Younger Patients with Hematologic Malignancies.   "
219893|NCT00729989|"     The stomach of the newborn baby is often emptied soon after birth to prevent breathing     problems (respiratory distress). Babies born with meconium-stained amniotic fluid and those     with increased secretions associated with birth by C-section are thought to be at particular     risk of breathing problems during the first minutes of life. Emptying the stomach by sucking     out all its contents (gastric suctioning) is alleged to lessen the risk of aspiration and     improve respiratory distress. This study will evaluate the usefulness of gastric suctioning     during neonatal resuscitation.   "
219894|NCT00730002|"     The purpose of this study is to determine if three functional Magnetic Resonance brain     imaging techniques: Magnetic Resonance Spectroscopy(MRS),Magnetic Resonance perfusion, and     Diffusion Tensor Imaging(DTI) can detect brain alterations distinctive for neuropsychiatric     systemic lupus erythematosus (NPSLE)and systemic lupus erythematosus(SLE).   "
219895|NCT00730015|"     The objective of this trial is to determine the efficacy and safety of linaclotide     administered to patients with chronic constipation (CC). The primary efficacy parameter is     the percentage of patients in each dosing group that meet the protocol definition for     Complete Spontaneous Bowel Movement (CSBM) Overall Responder.   "
219912|NCT00731679|"     To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in     providing adequate relief of IBS symptoms.   "
219937|NCT00732004|"     The principal aim of this project is to determine the time course of development of contact     lens and contact lens case contamination during daily wear of silicone hydrogel lenses. The     secondary aim of the study is to determine whether the time course of development of contact     lens and contact lens case contamination varies between two different contact lens care     systems.   "
219938|NCT00732017|"     The investigators hypothesis is that HVPC with negative polarity diminishes local     post-traumatic edema in ankle sprains. Therefore, the objective of this study was to analyze     the effect of HVPC on edema secondary to ankle sprains in humans.   "
219896|NCT00730028|"     The purpose of this clinical trial is to evaluate 2 different antibiotics, drugs that fight     bacteria, [clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX)] and wound care     for the outpatient management of uncomplicated skin and soft tissue infections (uSSTIs) in     children and adults. The study will occur in areas where community associated     methicillin-resistant Staphylococcus (S.) aureus are common. S. aureus is a type of bacteria.     A total of 1310 volunteers, greater than or equal to 6 months of age and adults 85 years or     younger, non-immunocompromised, with uSSTIs (in particular abscess and/or cellulitis) will be     enrolled in this study. Subjects will be treated with one of the following: CLINDA, TMP-SMX,     or placebo (contains no medication). Volunteers will be grouped based on the presence of     cellulitis or abscess, whether the abscess can be surgically drained, and its size. The     subject participation duration for this study is about 6 weeks.   "
219897|NCT00730041|"     The study will be done for the following purposes:        -  to see if Pillar implants in combination with CPAP therapy can help people with their          OSA by decreasing the CPAP pressures        -  to find out if receiving Pillar implants will increase CPAP use   "
219898|NCT00730054|"     The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to     relief acute main in an experimental human pain model. Of interest is also the effect of the     combination on respiration, sedation and cognitive behavior.   "
219899|NCT00730067|"     Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in     the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether     treatment of the increased pulmonary blood pressure betters the patients symptoms.      In this study 32 patients with increased pulmonary blood pressure due to COPD will be     randomized to 3 months treatment with placebo or sildenafil, which is known to lower the     pulmonary blood pressure in other types of pulmonary hypertension.      Our hypothesis is that treatment with sildenafil in these patients will improve the     functional capacity measured by the distance walked in 6 minutes and life quality.   "
219900|NCT00730080|"     Investigators at Washington University will examine the effects of sapropterin (Kuvan) on     brain and cognition in individuals with phenylketonuria (PKU) using neuropsychological and     neuroimaging procedures. Sapropterin is a medication developed by BioMarin Pharmaceutical     Inc. that is approved by the FDA for treatment of patients with PKU to reduce phenylalanine     (Phe) levels. Patients beginning treatment with sapropterin as standard clinical care will be     enrolled in the study. As a first step, patients with PKU will receive baseline     neuropsychological and neuroimaging evaluations 1 day prior to beginning treatment with     sapropterin. Screening for response to sapropterin will occur over 4 weeks. At the end of 4     weeks, response to sapropterin will be reviewed. Patients with a reduction of ≥ 20% in blood     Phe (i.e., responders) will receive follow-up neuropsychological and neuroimaging evaluations     after 6 months of treatment with sapropterin. Patients (both responders and nonresponders)     will receive long-term follow-up neuropsychological and neuroimaging evaluations 3 to 5 years     after initial enrollment in the study.      The focus of neuropsychological testing will be executive abilities, as these abilities are     particularly susceptible to disruption in individuals with PKU. We hypothesize that     improvements in these abilities will occur following treatment with sapropterin. For     neuroimaging assessments, structural magnetic resonance imaging (MRI) will permit evaluation     of changes in the structure and volume of the gray and white matter of the brain, whereas     diffusion tensor imaging (DTI) will permit evaluation of microstructural white matter     integrity.   "
219901|NCT00730093|"     During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through     increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is     crucial for the normal development af foetus during pregnancy.      In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the     woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation     for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test,     CobaSorb.   "
219902|NCT00730106|"     Gastroesophageal reflux disease (GERD) is diagnosed on the basis of characteristic reflux     symptoms (i.e. troublesome heartburn and/or acid regurgitation). Empirical therapy without     diagnostic endoscopy is suggested for those GERD patients presenting without alarm symptoms     in Western countries. Whether such treating instead of testing strategy should be applied     in Asia, an area with higher prevalence of Helicobacter pylori and gastric cancer, remains     uninvestigated.   "
219903|NCT00730119|"     This investigation is a multi-center study that will demonstrate that the GE Monitor meets     equivalency and/or accuracy and/or performance criteria. This investigation will compare the     test device(s) to itself, or one of the reference parameters, or a combination of parameters,     including NIBP, temperature, SpO2, respirations, and ECG.   "
219904|NCT00730132|"     This study is being performed to evaluate what variants of lipid-lowering therapy are used in     Russian clinical practice in coronary heart disease (CHD) patients with hypercholesterolemia     in whom the initial statin therapy did not achieve low density lipoprotein-cholesterol     (LDL-C) goals. Additionally, the efficacy and safety of all variants of modified     lipid-lowering therapy are to be evaluated.   "
219908|NCT00731627|"     Intracranial bleeding from ruptured blood vessels (called a subarachnoid haemorrhage -SAH)     affects 7000 patients each year in the UK and is a source of considerable death and     disability, even in young adults. Recent observations indicate that these bleeds can cause     reduced cerebral blood flow which leads to a bad outcome. High rates of death and disability     occur, and are particularly prevalent when low cerebral blood flow results in stroke.     Prevention of cerebral artery spasm and improvement in blood vessel reflexes are the target     of modern therapy. Candidate drugs include statins which have an impeccable safety record and     multiple potential beneficial actions (improve cerebral blood flow, reduce inflammatory     processes, reduce adverse blood coagulation) following SAH.      The investigators plan to use a statin, Simvastatin (40 mg) to improve cerebral blood flow     and reduce inflammation. We have already completed a phase 11 study (n=80) which demonstrated     potential benefits for acute statin therapy following SAH, and the investigators now wish to     conduct a multi-centre phase 111 study to explore any potential clinical benefits in a larger     population (n=1600). The purpose is to see whether the positive effects of statins seen in     our phase II study translate into clinical benefits - both short term (e.g. reduced need for     intensive care) and long term (outcome and wellbeing at 6 months).   "
219913|NCT00731692|"     The purpose of this study is to evaluate whether FTY720 is effective in delaying MS     disability progression compared to placebo in patients with PPMS. This was an open-label,     single-arm extension study to a double-blind, randomized multicenter, placebo-controlled,     parallel-group core study. The core study completed and eligible patients enrolled into the     extension study at the next scheduled or unscheduled core study visit. All patients,     regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension     study. The extension study was terminated early after the results of the core study became     available showing that the study did not meet its primary endpoint which was defined as     confirmed disability progression in this population   "
219914|NCT00731705|"     The doctors in the Bone Marrow Transplant Service at the Indiana University Cancer Center are     working to better understand how the immune cells that cause graft-versus-host disease (a     major complication of stem cell transplantation in which the donor immune cells attack the     patient's organs) can be selectively removed from the graft, leaving other immune cells that     fight infections.   "
219915|NCT00731718|"     The goal of this study is to see if heated air will kill head lice and their eggs. The     treatment visit is approximately 1 hour long with a follow up phone call.   "
219916|NCT00731731|"     This phase I/II trial studies the side effects and best dose of vorinostat when given     together with temozolomide and radiation therapy and to see how well they work in treating     patients with newly diagnosed glioblastoma multiforme. Vorinostat may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving vorinostat together with temozolomide and     radiation therapy may kill more tumor cells.   "
219917|NCT00731744|"     There is a growing interest in generating dendritic cells (DCs) for using as vaccines.     Several cytokines, especially stem cell factor (SCF) and FLT3-ligand (FL), have been     identified as essential to produce large numbers of myeloid precursors and even to increase     DC yield obtained by the action of granulocyte-macrophage colony-stimulating factor (GM-CSF)     and tumor necrosis factor alpha (TNF-α). However, there are few studies on the effect of the     early-acting cytokines, commonly used to expand CD34+ progenitor cells, on DC generation.      We have established a serious of functional analysis of maturated or immaturated DCs     including surface markers screening or cytokine production. Here, we design this two-year     project to evaluate the possible methodology in the generation of CD14+CD1a- and CD14- CD1a+     myeloid DC precursors from CD34+ cells. In the first year of the project, we will set up the     standard protocol to generate DC precursors from cord blood stem cells. In the first step, we     will isolate CD34+ cells from cord blood and amplify these cells. Purity of the CD34+ cell     populations obtained will be greater than 90%. In the next step, these primary cultures of     CD34+ cells will treat with early-acting cytokines such as GM-CSF and IL-4 to further     induction into dendritic cells. Functional analysis of dendritic cells would be performed in     this stage. In the second year of the project, we will further evaluate the induction of DCs     by CD34+ stem cells could be affected by combination of mesenchymal stromal cells. These     results of this research with CD34+-based DCs induction provide the basis for materials to     develop the DC-based vaccine against viral and fungal infections, and might be a powerful     tool in anti-tumor immunotherapy.   "
219918|NCT00731757|"     The purpose of this study is to determine the safety and efficacy of Humira in the treatment     of cutaneous sarcoidosis.   "
219929|NCT00731900|"     Topiramate (TPM) is an antiepileptic drug with a unique mode of action that is often useful     in patients refractory to other drugs. However its use is restricted by the high incidence of     cognitive adverse drug reactions (ADRs) that are associated with TPM exposure. TPM has been     shown to cause particular cognitive ADRs, characterized by verbal fluency, attention, working     memory and language deficits, at a much higher rate than other antiepileptic drugs. There do     not appear to be obvious differences between patients that do or do not experience cognitive     ADRs when on TPM (e.g. age, sex, concomitant medications, diagnosis), which suggests a     genetic contributor.   "
219919|NCT00731770|"     Fluticasone, an inhaled corticosteroid and salmeterol, a long-acting beta agonist, are     approved for use in the management of COPD. Fluticasone/salmeterol has been shown to     significantly improve FEV1 and decrease COPD symptoms (Calverley et al. 2003, 2007). Inhaled     corticosteroids have been shown to decrease frequency of COPD exacerbations (Gartlehner et     al. 2006) and long acting bronchodilators demonstrated a reduction in dyspnea, increased     airflow and reduction in hyperinflation in patients with symptomatic COPD (Ramirez-Venegas et     al. 1997). Specifically, salmeterol has also been shown to have a positive effect on symptoms     and health status of patients with COPD when added to usual treatment (Stockley et al. 2006).      Previous research of subjects from our group with asthma has shown salmeterol to be     associated with sustained improvements in morning PEF, protection from nighttime lung     function deterioration and improvement in patient perception of sleep (Wiegand et al. 1999).     This study has not been performed in patients with COPD nor has the effect of salmeterol with     fluticasone on sleep quality been assessed.      AIM: The aim of this study is to determine the effect of fluticasone/salmeterol on sleep     quality in patients with COPD and to compare efficacy of Advair 250 compared to placebo on     sleep.      The hypothesis is that there would be a significant improvement in sleep quality when     patients are placed on fluticasone/salmeterol as compared to placebo.   "
219920|NCT00731783|"     The purpose of this study is to determine whether measures to eliminate the Staph germ from     the skin of the index patient (with a special ointment and soap) are more effective when     performed by everyone in the household rather than the patient alone, and whether these     methods are effective in preventing future Staph infections. The investigators hypothesize     that there will be a greater number of households who are successful in eradicating the staph     germ from the index patient when all members of the household participate than households     where only the index patient is treated.   "
219935|NCT00731978|"     The purpose of this study is to evaluate if the InSpectra StO2 Monitor can safely guide the     amount of fluid needed during colorectal surgery.      The study hypothesis is that intraoperative fluid limitation can be safely accomplished when     guided by StO2 monitoring, and that this fluid restriction regimen will result in a reduction     in postoperative morbidity when compared to standard monitoring and fluid therapy.   "
219921|NCT00731796|"     This study is designed in two Phases. In phase 1, the Functional Outcome Measure will be     tested to determine its validity and reliability in three populations, subjects that have not     had a stroke and have no visual field defect, subjects that have had a stroke but do not have     a visual field defect, and lastly subjects that have had a stroke and have a visual field     defect. The second phase will employ an amended version of the functional outcome measure to     be administered to two groups of subjects. The first group of subjects will be those subjects     diagnosed with a visual field defect from retrochiasmatic insults and they will perform     vision restoration therapy. The second group with a similar diagnosis to the first but who do     not undergo vision restoration therapy.   "
219922|NCT00731809|"     18F-FDG PET/CT (2-[fluorine-18] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT)     is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in     the entire body. 18F-FDG uptake is caused by increased local metabolic activity. Such     increased uptake has been described not only in neoplastic lesions but also in inflammatory     lesions. In this condition, uptake has been correlated with local stimulation of tumor     necrosis factor, and with monocyte priming and activation. A physiologic variable uptake may     be observed in the bowel, especially the cecum, and has limited the use of PET in     inflammatory bowel diseases. The advantage of combined PET and CT devices lead to significant     improvements in the interpretation of the bowel areas, and greatly reduces the number of     false-positive findings in the gastrointestinal tract.   "
219923|NCT00731822|"     The purpose of this study is to assess the safety and efficacy of a single dosage strength of     GW685698/GW642444 in subjects with Chronic Obstructive Pulmonary Disease (COPD).   "
219924|NCT00731835|"     You are being asked to take part in this study because your doctor has determined that you     have an ischemic foot ulcer. This research study will compare two approved standard of care     treatment modalities for the management of ischemic foot ulcers. The ischemic foot ulcer     (wound) on your foot is a result of a blocked artery in your leg. The wound can sometimes be     healed with wound care alone, which includes dressing changes with creams and removing     (debriding) the dead tissue. Alternatively, the significant narrowing or blockage in one of     the arteries in your leg can be treated with several endovascular treatment techniques     including:        -  angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or        -  stent placement        -  atherectomy      The hypothesis of this study is that early endovascular or surgical intervention in subjects     with moderate arterial insufficiency and a non-healing foot ulcer results in a higher overall     incidence of wound healing in a significantly shorter period of time.   "
219925|NCT00731848|"     This study is an open-label extension to the double-blind GUP-0205-1 and double-blind     extension GUP-0205-1XX studies. High concentrations of anti-oxidants in pomegranate seeds     present a potential strategy to delay clinical prostate cancer progression and prolong the     interval from treatment failure to hormonal ablation. Eligible male subjects were previously     assigned to the placebo group in the double-blind core study or the double-blind extension     study and were diagnosed with disease progression while on placebo treatment. Upon satisfying     all entry criteria, the subjects will receive open-label pomegranate extract for up to 48     months in the absence of further disease progression or intolerable toxicity.   "
219926|NCT00731861|"     This study will evaluate PTK787, a new oral drug that stops blood vessel development, in     combination with Paclitaxel in patients with advanced solid tumors.   "
219927|NCT00731874|"     Tacrolimus (Prograf) is a medication that is commonly used in patients who receive a kidney     transplant. It is considered to be one of the most important medications that prevent     rejection of the transplant kidney by suppressing the immune system. Although tacrolimus is     good at preventing rejection, it does have some unwanted side effects. These side effects     include high blood pressure, increase in blood sugar, headache, and tremor. In addition,     tacrolimus causes some damage to the transplant kidney over time, by causing healthy tissue     to turn into scar tissue that does not function as well as healthy tissue. Therefore, kidney     function may be reduced over time. In the first three months after kidney transplant, Prograf     levels are kept between 8 to 10 ng/mL. This study will compare two groups of patients that     will both have their tacrolimus dose reduced slowly over three months to prevent rejection     while decreasing the risk of causing toxic effects to the kidney. One group will have their     Prograf levels kept between 6 and 8 ng/mL, while the second group will have their levels kept     between 3 and 5 ng/mL. We will then compare the two groups to see if there are any     differences in their kidney function over time.   "
219933|NCT00731952|"     The purpose of this study is to find out what effects (both good and bad) two medications     (VELCADE and Vorinostat) have on patients who have certain types of lung cancer. The study is     dose escalating meaning that patients will receive different doses of medication depending     on when they enter the study. Participation in the study will last approximately 3 months and     will include an initial screening visit, a visit once each week for 3 weeks to receive the     study medications, and then 2 additional visits around the time of your surgery to remove     your lung cancer tumor.   "
219934|NCT00731965|"     Background:      The safety of vaccination in patients with autoimmune diseases using immune suppressive     therapy is often discussed. Previous studies in Juvenile Idiopathic Arthritis (JIA) patients     showed no increase in disease activity after immunisation with dead vaccines. The safety of     the live attenuated Measles, Mumps, Rubella (MMR) vaccination was assessed retrospectively in     JIA patients and no increase in disease activity was found. However, this must be     prospectively confirmed. In addition, it is unknown whether vaccination is effective, since     the immune response to vaccination may be diminished due to immunosuppressive therapy for the     underlying disease. Finally, the influence of MMR vaccination on the immune system of JIA     patients has not been studied. Among others, regulatory T-cells (Tregs) should control the     immune response and prevent destructive autoimmune responses after environmental triggers     such as vaccination.      Objective:      The aim of the present study is to investigate the safety and efficacy of the MMR booster     vaccination and its influence on immune regulatory mechanisms in children with Juvenile     Idiopathic Arthritis.      Method:      JIA patients aged 4 to 8 years and treated by the pediatric rheumatology units from various     University Medical Centers in the Netherlands, are asked to participate in a prospective     study. In the Netherlands, measles-mumps-rubella (MMR) vaccination is included in the     National Vaccination Program and is normally administered at age 9. Included patients will be     randomised for early vaccination (age group 4 to 8yr at entry of the study) or at age 9 as is     routinely done according to the National Vaccination Program. Prior to and after vaccination     the investigators will assess disease activity and collect blood.      Outcome:      During a 12 month follow-up period the investigators will register disease activity and     side-effects at different moments in time to determine safety of vaccination. The efficacy of     the vaccine will be studied according to antibody levels and function against measles, mumps     and rubella in the blood. Tregs will be isolated and their functionality will be determined     using the blood cells collected during follow-up. This enables us to study the role influence     of vaccination on regulatory mechanisms in our immune system.   "
219939|NCT00732030|"     Study evaluates the visual outcomes and patient satisfaction after implantation of a toric     intraocular lens (IOL).   "
219940|NCT00732043|"     High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to     delay clinical prostate cancer progression and prolong the interval from primary treatment     failure to hormonal ablation. This is a 48 month extension to the double-blind GUP-0205-1     study, to compare the effects of daily consumption of pomegranate liquid extract versus     placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12, 24,     36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study.   "
219941|NCT00732056|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of GRN163L in     combination with paclitaxel and bevacizumab in patients with locally recurrent or metastatic     breast cancer (MBC)   "
219942|NCT00732069|"     Little is known about how some drugs affect inflammation or clotting factors in people     receiving hemodialysis. It is not yet known if these drugs help prevent heart damage as they     do in people not undergoing hemodialysis or whether they could increase the risk of heart     problems. The purpose of the study is to measure certain chemicals in the blood and see how     those chemicals may change during hemodialysis when certain drugs are given.   "
219943|NCT00732082|"     The overall purpose of this research is to evaluate the safety and toxicity of an     investigational medication, IMP321, in patients being treated with gemcitabine. IMP321 is a     synthetic protein (made in the laboratory to simulate a protein that your body makes on its     own) and was designed to stimulate the immune system with the overall objective of improving     the body's capacity to react to your pancreas cancer.   "
219944|NCT00732095|"     Research has found that natural recovery (self-change) is a very common pathway to change for     individuals with alcohol problems, accounting for nearly 75% of recoveries in several     national surveys.      Although few members of the public are aware that self-change is possible, it also is the     case that many individuals with alcohol problems do not enter treatment because of the stigma     or fear of being labeled. The proposed study is based on findings from a recent randomized     controlled trial designed to promote self-change in the community for problem drinkers who     had never been in treatment. Media advertisements were used to recruit 825 participants.     Eligible respondents were sent assessment materials to complete. After the assessment     materials were returned, participants were randomly assigned to receive two alcohol pamphlets     that were freely available in the community or personalized feedback based on their     assessment responses (e.g., how their drinking compared to national norms, health risks     associated with their drinking). A 1-year follow up found that while there were no     differences in drinking behavior between the groups, both groups had very substantial     reductions in their drinking 1-year pre- to 1-year post-intervention. In an attempt to     determine what accounted for the change, participants' reports of their drinking were     evaluated with regard to critical study elements (e. g., when assessment materials were     received). Surprisingly, results revealed that many changed after seeing the advertisement,     and before receiving the assessment materials to complete. This suggests that either seeing     the ad (Thinking about changing your drinking?) or a message in the ad (Did you know that     75% of people change their drinking on their own?) may have catalyzed the change. To     evaluate when change occurs and the mechanisms that may give rise to change, a randomized     controlled trial involving 3 groups will be conducted. The groups will differ in whether they     receive a message informing them that self-change is a common phenomenon (two groups will     receive the message, one will not) and the occasion when the message is delivered (consenting     to the study and before the assessment vs. with the intervention material). Comparisons made     possible by the experimental design will allow an evaluation of the message as a precipitant     of change. The use of Timeline Followback retrospective reports of daily drinking and     recording of critical dates will allow statistical analysis of patterns of inflection (i.e.,     change in drinking) related to seeing the ad, receiving the message, receiving and completing     the assessment materials, and receiving the intervention materials. Possible explanations for     how the message could function as a mechanism of behavior change are offered (e.g.,     catastrophe theory, cognitive social learning theory). The ultimate objective of this     research is to develop cost-effective, large scale interventions that can be viewed as an     early stage in a public health, stepped care model by encouraging self-change for individuals     with alcohol problems.   "
219945|NCT00732108|"     The purpose of this study is to determine whether topiramate effective in treating dizziness     symptoms that are associated with migraine headaches.   "
219946|NCT00732121|"     Background:      Incretin hormones are hormones produced by the gut in response to food intake. These hormones     help the body to control the metabolism of glucose (sugar). In particular, two incretin     hormones (GLP-1 and GIP) cause the pancreas to secrete more insulin in response to high blood     glucose levels. This helps the body to metabolize the glucose more effectively, lowering     blood sugar levels. In addition to their effects on the pancreas, GLP-1 and GIP have effects     on other tissues, including the brain, gut, fat cells and bone. A new class of oral drugs     developed for the treatment of type 2 diabetes mellitus (T2DM) called DPP-4 inhibitors     increases levels of the active forms of GLP-1 and GIP in the body by preventing their     breakdown. This study tests whether a medicine in this class called sitagliptin (Januvia),     which is commonly used to treat T2DM, affects markers of bone turnover in patients with T2DM.     The hypothesis is that treatment with sitagliptin will increase markers of bone formation and     decrease markers of bone resorption during a mixed meal, by enhancing active circulating     levels of GLP-1, GIP and GLP-2.      Methods:      To address this question we will recruit patients with T2DM whose diabetes is controlled with     either diet+exercise or with metformin (another medicine commonly used to treat T2DM).     Subjects will undergo measurement of body fat and bone mineral density by DEXA scanning and a     3-hour mixed meal test. During the mixed meal test blood samples will be taken to measure how     much GLP-1 and GIP are produced. Markers of bone formation will also be measured in blood     samples obtained during the mixed meal test. Subjects will then be randomly assigned to 8     weeks of treatment with either sitagliptin (100 mg/day) or matching placebo (an inactive     tablet that does not contain medication). Subjects will be seen 4 weeks after commencing     treatment to assess safety and tolerability. After 8 weeks of treatment the meal test will be     repeated. Subjects will then be washed off of their initial treatment (sitagliptin or     placebo) for 1 week (that is, they will receive no study medication during this period).     After the washout period, they will commence a second 8-week period of treatment with the     other study medication (that is, if they received sitagliptin initially, they will receive     placebo during period 2 and vice-versa). At the end of period 2, subjects will undergo a     third mixed meal test with measurement of GLP-1, GIP and markers of bone turnover.      Significance:      Recent studies suggest that oral antidiabetic medications of the thiazolidinedione class,     such as rosiglitazone (Avandia) and pioglitazone (Actos), may weaken bones, increasing the     risk of fractures in older women with diabetes. The proposed study will test whether drugs of     the DPP-4 inhibitor class, such as sitagliptin (Januvia), have beneficial effects on bone     turnover by increasing the activity of GLP-1 and GIP. Results of this pilot study may suggest     the need to perform longer-term studies to determine whether DPP-4 inhibitors increase bone     mineral density and reduce the risk of fractures in patients with diabetes.   "
219947|NCT00732147|"     Diabetes affects almost 21 million people in the United States. In this study we will test a     drug called Pramlintide(Symlin), and see how it works to lower blood sugar and fat levels     after a meal. Lowering high sugar levels and fat levels after a meal is very important in the     prevention of the problems that persons with type 2 diabetes often encounter. Hypothesis is     that Pramlintide will lower blood sugar and fat levels after a meal.   "
219948|NCT00732160|"     Determine the effect of aldosterone on how the body handles glucose (sugar).   "
219949|NCT00732173|"     RATIONALE: Participating in a diet and exercise program may improve the quality of life of     overweight and obese patients who are in remission from endometrial cancer.      PURPOSE: This randomized phase I trial is studying an exercise and healthy diet program to     see how well it works compared with standard care in patients in remission from stage I or     stage II endometrial cancer.   "
219950|NCT00732186|"     The purpose of the study is to assess the safety of ipilimumab and dasatinib combination     therapy in patients with CML   "
219951|NCT00732199|"     The purpose for this research protocol was to examine the role of breathing control     mechanisms that determine the development of sleep-disordered breathing in the elderly. This     proposal focused on key factors that contribute to the control of ventilation in elderly     adults during sleep. The investigators studied the age-specific changes in ventilatory     control in older and young adults during NREM sleep.   "
219962|NCT00732355|"     The study is designed to evaluate the performance of a rapid membrane test in a clinic or     doctor's office setting to identify potential patients infected with syphilis and compare the     results to currently licensed laboratory based tests.   "
219952|NCT00732212|"     The main purposes of this study are to compare clinical outcomes of two groups of patients     with similar medical conditions (one with non-variceal upper gastrointestinal (UGI) lesions     such as ulcers and another group with varices or portal hypertensive lesions) who are treated     either with current standard visually guided endoscopic treatment according to stigmata of     hemorrhage or with endoscopic Doppler endoscopic ultrasound probe (DEP) monitoring of blood     flow in the lesion.   "
219953|NCT00732225|"     A comparison of the ability of DisCoVisc to that of other Opthalmic Viscosurgical Devices     (OVDs) (DuoVisc®, BioVisc®, Healon5®, or Amvisc PLUS) regarding endothelial protection and     anterior chamber space maintenance during non-eventful cataract surgery.   "
219954|NCT00732238|"     The specific objective of this clinical trial is to demonstrate that a multifaceted approach     for treatment for catheter-related urinary tract infection (UTI) in patients with spinal cord     injury is effective and feasible. We plan to test the following hypothesis: a multifaceted     treatment approach that consists of immediate removal of the indwelling bladder catheter,     selecting antibiotics based on the finding from a urine culture that is obtained through the     newly inserted catheter, and a 5-day course of systemic antibiotics will effectively treat     catheter-related infection that is limited to the lower urinary tract of patients with spinal     cord injury.   "
219955|NCT00732251|"     The purpose of this study is to investigate the efficacy of allopurinol as an augmentation     agent for the prevention of mania in bipolar disorder patients with currently stable mood.   "
219956|NCT00732277|"     Severe bacterial infections affecting multiple body organs, called severe sepsis (including     meningococcal sepsis), remain an important cause of death and disability among children.     Although early recognition, powerful antibiotics, and good intensive care have improved     outcome, we need new ways to further reduce the number of deaths. Research in adults has     shown that steroid replacement therapy might be useful. However, children are known to     respond differently to adults and a definitive trial in children is needed because of the     potentially harmful as well as beneficial effects of steroids.      This pilot study will provide the necessary information to allow the rational design of a     large trial conducted at multiple hospitals investigating the role of corticosteroid     replacement therapy in childhood sepsis. The study will provide information on how to measure     the effects of steroids, information on length of therapy and a better understanding of how     steroids work in children. The results emerging from this study will ultimately allow     paediatric intensive care clinicians to know whether or not steroids are safe and/or useful.      The primary objective of this open−label study is therefore to gather clinical and laboratory     data with which to inform the design of a large phase 3 double blind randomised controlled     trial (RCT). The study will provide basic limited safety data, information on length of     therapy and an assessment of possible clinical and laboratory endpoints to be used in     addition to mortality.      Definition of sepsis:      Presence of a documented infection (eg clinical evidence of pneumonia, skin or soft tissue     infection, purpura fulminans, urinary tract infection, abdominal infection) or a diagnostic     positive blood culture (community or hospital acquired) within the last 72 hours and at least     two of the following, one of which must be abnormal temperature or leucocyte count[3] core     temperature of >38.5°C or <36°C; tachycardia (mean heart rate >2 SD above normal for age);     mean respiratory rate > 2 SD above normal for age; leucocyte count elevated or depressed for     age.      Definition of severe sepsis:      Sepsis plus cardiovascular organ dysfunction (the need for at least 5mcg/kg/min dopamine or     dobutamine, or any amount of adrenaline or noradrenaline support), acute respiratory distress     syndrome (ARDS), or 2 or more other organ dysfunctions.   "
220000|NCT00732862|"     Hypoglycemia or low blood sugar is a very serious complication that diabetics experience.     This is of great concern because there is a lack of available information of how Non Insulin     Dependent Diabetic Mellitus patients (NIDDM) defend themselves against a low blood sugar.     This is particularly disturbing since NIDDM patients are likely to require intensive     treatment, and as a result, the risks of severe hypoglycemia to the NIDDM patient increase.     The current proposal aims to provide information on how NIDDM patients can defend themselves     against hypoglycemia, thus decreasing their risks for this severe complication.   "
219957|NCT00732290|"     Clopidogrel is a platelet aggregation inhibitor witch prevents thrombotic events in patients     with atherosclerotic vascular disease. To date, 4 to 30 % of patients are considered as poor,     low or non-responder to this therapeutic. However, drug-drug interactions may lead to     decrease the clopidogrel responsiveness. Many arguments are in support to a drug-drug     interaction between clopidogrel and fluoxetine (selective serotonin reuptake inhibitor). On     the pharmacokinetic level, fluoxetine inhibits the cytochroms involved in the production of     clopidogrel active metabolite. On the pharmacodynamic level fluoxetine could increase the     risk of hemorrhage by inhibiting the serotonin platelet reuptake and thus enhance the     antiplatelet effect of clopidogrel.      The purpose of this study is to investigate the influence of fluoxetine on pharmacokinetic     and pharmacodynamic of clopidogrel.   "
219958|NCT00732303|"     Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent     activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this     study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC.   "
219959|NCT00732316|"     RATIONALE: Giving low doses of chemotherapy and antithymocyte globulin before a donor stem     cell transplant helps stop the growth of cancer and abnormal cells. It may also stop the     patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune cells and help destroy any remaining cancer and abnormal cells     (graft-versus-tumor effect).      PURPOSE: This phase II trial is studying how well a donor stem cell transplant works after     busulfan, fludarabine, and antithymocyte globulin in treating patients with hematologic     cancer or myelodysplastic syndrome.   "
219960|NCT00732329|"     The purpose of this study is to determine if a home based occupational therapy is effective     in the treatment of dementia.   "
219961|NCT00732342|"     310 alcohol abusing or dependent patients beginning intensive outpatient day treatment at     community-based clinics will be randomly assigned to one of four conditions: (a) standard     treatment as usual (ST) at the clinic without contingency management (CM); (b) standard     treatment with contingency management for 12 weeks with a 0.5 probability of winning prizes     for each negative sample submitted; (c) standard treatment with contingency management for 24     weeks with a 0.34 probability of winning prizes for each negative sample submitted; or (d)     standard treatment with contingency management for 24 weeks with a 0.5 probability of winning     prizes for each negative sample submitted. We expect that contingency management will     decrease alcohol use to a greater extent than non-contingency management treatment, and that     availability of contingency management for 24 weeks may result in longer term benefits than     12 week exposure to contingency management. This study will be the first to evaluate the     effects of probability of winning prizes on response to contingency management.   "
225397|NCT00802633|"     Evaluate the utility/safety of an FDA-approved tissue sealing device during radical     cystectomy as compared to an FDA-approved stapling device.   "
219963|NCT00732368|"     This study examined the safety and effectiveness of long-term administration of mometasone     nasal spray in patients with perennial allergic rhinitis. Patients received mometasone for 12     weeks plus an additional 12 weeks if patient agreed to continue. Dose of mometasone could be     decreased or increased during the study based on patient's response.   "
219964|NCT00732381|"     This study seeks to prospectively demonstrate that Nasonex is better than placebo in     relieving nasal congestion in patients with seasonal allergic rhinitis.   "
219965|NCT00732394|"     To administer the MSDR® (Musculoskeletal Disorder Reporting) instrument to document the     musculoskeletal profile of patients with chronic low back pain, a prospective,     non-randomized, multicenter treatment trial   "
219966|NCT00732407|"     Aliskiren is a novel renin inhibitor approved for the treatment of hypertension. The effect     of aliskiren on arterial stiffness, inflammation and oxidative stress has not been fully     investigated yet.The aim of this study is to investigate the effect of aliskiren on arterial     stiffness, platelet function and inflammation compared to losatan in patients with diabetes     mellitus.      We hypothesize that aliskiren will have a beneficial effect on arterial stiffness and     platelet function in patients with diabetes mellitus.   "
219967|NCT00732420|"     To determined what dose of topotecan can be safely given with daily pazopanib.   "
219968|NCT00732433|"     The purpose of this study is to develop computer programs to assist radiologists in finding     breast cancer on mammograms and to compare the computer's accuracy of detecting cancers on     direct digital and film mammograms.   "
219969|NCT00732446|"     Safety and efficacy of antibiotic steroid combination compared with individual administration     in the treatment of bacterial ocular inflammation and infection (blepharitis and/or keratitis     and/or conjunctivitis).   "
219970|NCT00732459|"     The purpose of this study is to investigate the protective effect of electro-acupuncture     preconditioning in patients underwent cardiac surgery.   "
219971|NCT00732472|"     The study drug which is an inhaled bronchodilator (lung airway relaxant)has been given to     both healthy volunteers and to COPD patients before. This study will assess a new formulation     of GSK573719. Many drugs are known to deteriorate over time. To make the study medicine less     likely to deteriorate in its container, it is mixed with an inactive substance that helps to     to maintain the quality of the study medicine. Previous studies have looked at GSK573719 with     another inactive substance called Cellobiose Octaacetate (COA). This study will be looking at     a new formulation of GSK573719 using Magnesium Stearate (MgSt) as the inactive substance.     MgSt itself is not a medicine but is approved as a food ingredient and has also has been     approved to be used in a number of marketed medical inhalers. The purpose of this study is to     assess the safety and tolerability of compound GSK573719 with Magnesium Stearate for     once-daily treatment of COPD(Chronic Obstructive Pulmonary Disease). This drug will be given     to 2 groups of 12 people for 7 days. Group 1 will receive 250mcg or placebo and group 2 will     receive 1000mcg or placebo. Group 2 will not be dosed until at least 6 people have completed     dosing in group 1 without any significant safety concerns. The following safety measures will     be assessed including: ECGs, heart rate, blood pressure, blood samples for safety labs, lung     function and 24 hour monitoring of the heart. We will also take blood and urine samples to     measure medication levels in the body.      GlaxoSmithKline will be funding the research and it will be recruiting at Synexus in 7 of     their centres in the UK.   "
219972|NCT00732485|"     Major burn injury causes significant insulin resistance on glucose and protein metabolism     that persists for up to 6 months after the acute injury      This project proposes to answer the following questions:        1. Will fenofibrate given to burn patients with insulin resistance restore their insulin          sensitivity?        2. What is the relationship between mitochondrial dysfunction in muscle tissue as the          causative mechanism of burn related insulin resistance?        3. To what extent will the restored insulin sensitivity affect glucose and protein          metabolism in muscle, regenerating wounds and the liver, i.e. ameliorate burn related          hyperglycemia and protein catabolism?   "
219973|NCT00732498|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as rituximab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90     ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them     without harming normal cells. Giving combination chemotherapy together with rituximab and     yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.      PURPOSE: This phase II trial is studying giving combination chemotherapy followed by     rituximab and yttrium Y 90 ibritumomab tiuxetan to see how well it works in treating patients     with relapsed stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.   "
219974|NCT00732511|"     We are comparing the blood pressure-lowering effects of two marketed medications, Coreg CR     and Toprol XL. Although both drugs reduce blood pressure by blocking the action of     noradrenaline on beta-receptors in the blood vessels, Coreg CR also blocks alpha-receptors,     which may provide added blood pressure-lowering. In addition, Coreg CR may have anti-oxidant     actions. Cells which line blood vessels (termed endothelial cells) make nitric oxide (NO),     which relaxes the muscle cells encircling the blood vessels, causing a reduction in blood     pressure. When body cells use oxygen, they normally produce free radicals, which can     destroy NO,leading to high blood pressure, heart damage and worsenimg of diabetes.     Antioxidants remove free radicals and prevent or repair this damage. In this study we will     measure endothelial cell function, blood vessel wall stiffness, NO in exhaled breath, and     blood levels of substances which reflect NO production and destruction to determine if a pure     beta-blocker (Toprol XL) differs from an alpha/beta blocker (Coreg CR) in these effects. We     will also examine the mechanism by which such differences might occur.   "
219975|NCT00732524|"     The purpose of this study is to compare two simple and safe emergency department discharge     therapy for Type 2 Diabetes patients with severe hyperglycemia and with no indications for     inpatient admission.   "
220031|NCT00733265|"     The main purpose of this study is to examine how AZD6140 affects patients with severe kidney     disease compared to volunteers with normal kidneys. Subjects in the study will receive one     dose of AZD6140.   "
219976|NCT00732537|"     Inhaled nitric oxide (iNO) improves oxygenation in term infants with respiratory failure.     However, iNO has been primarily used in infants receiving mechanical ventilation. This study     is a pilot study to determine if iNO given into an oxygen hood is effective in improving     oxygenation in term and near-term infants who have poor oxygenation but who are not yet     mechanically ventilated.   "
219977|NCT00732550|"     The purpose of this study is to determine the advantages of single trocar cholecystectomy     over standard laparoscopic cholecystectomy.   "
219978|NCT00732563|"     RATIONALE: Diagnostic procedures using fludeoxyglucose F 18 and a surgical probe may help     find lymph node metastases in patients with early-stage non-small cell lung cancer.      PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 works in detecting     lymph node metastasis in patients with stage I or stage II non-small cell lung cancer that     can be removed by surgery.   "
219979|NCT00732576|"     Omega-3 fatty acids are notably present in fish oil and krill oil, and are known to have     beneficial effects on the vasculature. Vitamin K2 is known for preventing vascular     calcification. In this study we investigate a potential synergy between the effects of either     fish or krill oil and menaquinone-7, which is one of K2 vitamins.   "
219980|NCT00732589|"     The purpose of this study is to compare suprascapular nerve block with therapeutic ultrasound     in stroke patients who have shoulder pain in weak side.   "
219981|NCT00732602|"     The purpose of this study is to determine whether Glucose-dependent Insulinotropic     Polypeptide (GIP) or Glucagon Like Peptide 2 (GLP-2) has an affect on the secretion of     Glucagon from the pancreas in patients with type 1 diabetes mellitus.   "
219982|NCT00732615|"     Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with     hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D     supplements.   "
219983|NCT00732628|"     The purpose of this study is to evaluate the safety and effectiveness of the Boomerang     percutaneous closure device following diagnostic cerebral angiography or neurointerventional     procedures.      Background:      Very few publications have evaluated this relatively novel percutaneous closure device.   "
219984|NCT00732641|"     This study aims to assess the efficacy of peginterferon α-2b, compared to a control arm not     receiving any maintenance treatment, in adult subjects with multiple myeloma who have     responded to a prior induction therapy. Peginterferon α-2b will be given once weekly as an     injection until disease progression or relapse, or for up to a maximum of 5 years (whichever     occurs first).   "
219985|NCT00732654|"     The purpose of this study is to determine if small oral and sublingual doses of milk protein     are safe and effective in decreasing sensitivity to cow's milk in allergic children.   "
219986|NCT00732680|"     Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable     distress. To date there is no definitive cure for these symptoms. Established treatment     modalities include saline irrigation, surgical implantation of materials or simply use of     cotton wads/ silicon cones to simulate the resistive action to airflow of the resected     turbinates.      This study will research the effectiveness of a new treatment modality in the treatment of     Empty Nose Syndrome. This novel treatment method involves the use of botulinum toxin type A     (Botox).   "
219987|NCT00732693|"     The aim of the study is to determine whether physiological sex steroid replacement improves     parameters of skeletal, cardiovascular and reproductive health of women treated with current     sex steroid replacement regimens.   "
221494|NCT00743912|"     The primary objective of this study is to determine if rifaximin, administered daily has an     effect on the cytochrome P450 (CYP) isoenzyme 3A4, by examining any changes in the     pharmacokinetics of midazolam (a CYP3A4 substrate), when co-administered.   "
219988|NCT00732706|"     Nerve blocks are an effective way to control pain after surgery. There are two major nerves     that provide sensation to the knee: the femoral nerve provides sensation to the front of the     knee and sciatic nerve provides sensation to the back of the knee. The femoral nerve has two     branches. To locate the nerve, we use a machine called (Nerve stimulator) which is attached     to the needle used for nerve block. Use of a nerve stimulator is standard practice for this     procedure. Ultrasound is being increasingly used to locate nerves but is not used     universally. We will use the nerve stimulator and ultrasound to locate the femoral nerve but     patients will randomly be selected to enter a group looking at the stimulation of one or the     other branches of the femoral nerve. The two branches when stimulated produce different     muscle contractions in the thigh. We do not know from research which is the optimal     contraction to position the needle to get the best block. After the knee replacement patients     will still have the same analgesic medication available as patients would have received if     they were not in the study.   "
219989|NCT00732719|"     To evaluate the safety of the prototype Compression Device in subjects with Oedema   "
219990|NCT00732732|"     Green banana has been traditionally used in diarrheal and other diseases. Recent studies have     shown that green banana is beneficial in children with diarrhea.      The purpose of this study is to try green banana in a portable, storable and dosable form in     infants with diarrhea.      Infants with diarrhea and meeting the inclusion criteria will receive either green banana     powder or placebo (microcrystalline cellulose). Their response will be monitored for 10 days.     The subjects, parents and researchers conducting the study will not know whether banana     powder or placebo is being given to that particular subject (double blind randomized study).      Two hundred patients will be enrolled in 24 months.   "
219991|NCT00732745|"     RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. It is not yet known whether     vandetanib is more effective than a placebo when given together with oxaliplatin and     docetaxel in treating advanced cancer of the esophagus or gastroesophageal junction.      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of     vandetanib when given together with oxaliplatin and docetaxel and to see how well it works in     treating patients with advanced cancer of the esophagus or gastroesophageal junction.   "
220681|NCT00741884|"     The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice     daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of     varenicline controlled release (CR) tablets in adult smokers.   "
219992|NCT00732758|"     The study objective is to characterize the threshold levels of serum 25-hydroxyvitamin D for     the definition of vitamin D insufficiency in 8-14 year old African American and Caucasian     children.      We propose a 6 month randomized placebo controlled trial of vitamin D (vitamin D3 1000 IU/day     vs. placebo) initiated during October through March (during fall and winter) in 8 to 14 year     old African American and Caucasian children. The results of the trial will help establish the     cutoff threshold value of serum 25(OH)D for defining vitamin D insufficiency in preadolescent     and adolescent children. Safety of vitamin D supplementation will be assessed by measuring     serum calcium at 0, 2 and 6 months and by monitoring for adverse events. Currently     recommended adequate intake for vitamin D of 200 IU daily may not meet the body's daily needs     for vitamin D. Therefore, it is likely that a higher level of daily vitamin D intake may be     needed to meet the body's skeletal and non-skeletal demands for vitamin D. Determining the     dietary required intake of vitamin D for the prevention of vitamin D insufficiency during     childhood has immense public health potential for addressing health disparities and ensuring     better bone health during adulthood. The primary outcome measure will be serum 25(OH)D and     parathyroid hormone (PTH). The secondary outcome measures will include: markers of bone     formation (serum P1NP) and bone resorption (serum CTX).We will also examine differences in     serum 25(OH)D, PTH, and markers of bone turnover in African American vs. Caucasian children.   "
219993|NCT00732771|"     The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can     lower BP in patients with Primary hyperaldosteronism.   "
219994|NCT00732784|"     This research study is being conducted through the University of Pittsburgh Cancer Institute     (UPCI). It will evaluate the concentrations of Gleevec®, an oral drug used to treat some     types of cancer, in the blood of healthy volunteers when taken with and without Tums Ultra®,     a calcium product often used in the treatment of upset stomach and as a calcium supplement.   "
219995|NCT00732797|"     The investigators primary aim is to test whether or not provision of the self-help booklet     teaching VR exercises, with up to one hour of telephone support from a vestibular therapist,     will be more effective than routine care in reducing symptoms in dizzy patients in primary     care. The investigators will also explore the extent to which patients may benefit from the     self-help booklet without support. The investigators will determine whether these models of     delivery are less costly than routine care of dizzy patients, as they should reduce the     number of patients seeking referral to secondary care for unnecessary assessments.   "
219996|NCT00732810|"     To determine the activity of SCH 727965 in participants with breast cancer and in     participants with nonsmall-cell lung cancer (NSCLC) compared to standard treatment. The     standard treatment used is capecitabine for breast cancer and erlotinib for NSCLC. The study     will also determine the activity of SCH 727965 treatment in participants who experience     cancer progression after standard treatment.   "
219997|NCT00732823|"     To evaluate the safety of the Compression Device to subjects with venous insufficiency and     oedema.   "
219998|NCT00732836|"     The goal of this clinical research study is find the highest tolerated dose of Abraxane     (nab-paclitaxel) that can be given directly into the liver of patients with advanced cancer     that has spread to the liver.   "
219999|NCT00732849|"     The study was designed to test the hypothesis that immunonutrition and enteral nutrition     would reduce the incidence of infectious complications in a population of malnourished     patients following elective upper GI surgery   "
220013|NCT00733031|"     The primary purpose of this study is to find out what the maximum tolerated dose is for an     experimental drug called AZD6918 based on the side effects experienced by patients with     advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918     will be administered twice daily. Then maximum tolerated doses in combination with either     gemcitabine or pemetrexed will also be investigated.   "
220001|NCT00732875|"     This trial is extension part of the P04280 (placebo-controlled, double-blind, randomized     study of chronic treatment with infliximab in approximately 140 patients, NCT00202852). This     study will be conducted at 6 study centers in South Korea. After completion of the last     follow-up visit at Week 30 and code break in main double-blind trial, subjects randomized to     the placebo group and those who were treated with an infliximab-containing regimen who     maintained clinical response at the time of study completion will be provided with open-label     infliximab for treatment of their conditions and additional safety data will be collected.   "
220002|NCT00732888|"     This research study is being conducted through the University of Pittsburgh Cancer Institute     (UPCI). It will evaluate the concentrations of Tasigna®, an oral drug used to treat some     types of cancer, in the blood of healthy volunteers when taken with and without Tums Ultra®,     a calcium product often used in the treatment of upset stomach and as a calcium supplement.   "
220003|NCT00732901|"     The purpose of this study is to examine the relationship between 5-HT2R function, impulsivity     and cue reactivity in cocaine dependent subjects and healthy controls and examine specific     effects of escitalopram and mirtazapine on impulsivity and cue reactivity in human cocaine     users.   "
220004|NCT00732914|"     Primary:      To evaluate if progression-free survival from first treatment to progression or death during     second-line therapy (total PFS) of sorafenib followed by sunitinib is superior compared to     sunitinib followed by sorafenib.      Secondary:        1. Time from first treatment to progression during second-line therapy (total TTP)        2. Time to first-line treatment failure (progression, death, discontinuation due to          toxicity) descriptively in each arm        3. PFS in first-line and second-line treatment, descriptively        4. Overall survival, descriptively (data cut-off same as for primary endpoint)        5. Disease Control Rate (DCR); Response rates in first-line and in second-line (CR, PR, SD          according to RECIST criteria)        6. Cardiotoxicity analysis by means of echocardiography and NT-pro BNP with an interim          analysis after 100 patients of each arm have completed the study        7. Safety and tolerability   "
220032|NCT00733278|"     This is a pilot study of up to 10 women, which will test the hypothesis that the placement of     copper IUDs through the uterine incision at the time of uncomplicated elective C-section is     technically feasible and acceptable to women seeking long-term contraception.   "
220033|NCT00733291|"     The purpose of this study is to evaluate daily disposable lenses inserted out of the blister     package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution     FID 107027.   "
220005|NCT00732927|"     Retinal vein occlusion (RVO) is the second commonest retinal disease after diabetic     retinopathy, and is a common cause of unilateral visual loss. There are two aims in the     management of RVO: the identification of modifiable risk factors and their medical management     and the recognition and management of sight-threatening complications. The management of the     disease includes laser therapy and the control of systemic associated diseases. Many other     treatments have been proposed but there is no evidence on their efficacy in modulating the     outcome of branch or central RVO. There are currently no adequate clinical trials that have     evaluated the efficacy and safety of antithrombotic agents in this setting. Antiplatelet     agents are frequently used in clinical practice. Anticoagulant drugs, either heparins or     coumarins, are also used in this setting as they represent the first line therapy for the     treatment of venous thromboembolism. Aim of this randomized controlled study is to to compare     the efficacy and safety of aspirin and of a low molecular weight heparin, parnaparin, in the     treatment of RVO. Study treatment is administered for 3 months. Primary end-point of the     study is the incidence of functional worsening of the eye with RVO at 6 months. Secondary     efficacy outcomes are the following: proportion of cases requiring laser treatment because of     the extension of the ischemic lesion and/or the presence of neovascularisation and/or macular     oedema, incidence of recurrent RVO objectively documented by fluorescein angiography. Safety     outcomes are defined by the incidence of major and minor bleeding events.   "
220006|NCT00732940|"     The purpose of this study is to test the safety and tolerability of repeated subcutaneous     (SC) doses of belimumab in subjects with SLE.   "
220007|NCT00732953|"     Percutaneous coronary intervention with stent implantation is limited on the one hand by     restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis     due to incomplete or not sufficient enough endothelialization of stent struts. The Genous     stent implantation allows a rapid layer over the stent struts with endothelial progenitor     cells allowing a fast endothelialization and probably reducing the risk of stent thrombosis.     Local therapy with drug-eluting balloons administering paclitaxel has been shown to reduce     restenosis in in-stent restenosis and de-novo lesions in vessels with small reference     diameter. The combination of a paclitaxel-eluting balloon and Genous stent implantation may     summarized both advantages: a rapid endothelialization limiting the number of stent     thrombosis and on the other hand a reduction of smooth muscle cell proliferation minimizing     the risk of restenosis with the subsequent need for revascularization.   "
220008|NCT00732966|"     Most Angiotensin receptor blocker's (ARBs) are metabolized by cytochrome P4502C9 (CYP2C9),     one of the major isoforms of the cytochrome P450 in human liver microsome. The purpose of     this study is to evaluate whether CYP2C9 polymorphism has a significant clinical influence on     the blood pressure lowering effect of losartan and valsartan. Weather there is a genetic     importance in choosing the right ARB for the right patient.   "
220009|NCT00732979|"     Intraoperative blood loss is a major concern during hepatic resection, as it has been shown     to adversely affect patients' perioperative outcome. Reduction of central venous pressure     during parenchymal transection has been shown to effectively lower liver hemorrhage. While     CVP reduction is mainly achieved via fluid restriction and diuretics, dehydration may impair     organ function. Moreover, it may lead to hemodynamic instability, particularly in case of     severe bleeding. For this reason the technique of infrahepatic inferior vena cava clamping     has been suggested which is able to lower CVP without the need for fluid restriction.      In the present study the two strategies to reduce CVP and by this intraoperative bleeding,     namely fluid restriction and inferior vena cava clamping are compared with intraoperative     blood loss as primary endpoint.   "
220010|NCT00732992|"     This study will assess if the combination of sunitinib and pemetrexed is tolerable when     coadministered at each recommended dose/schedule.   "
220011|NCT00733005|"     This study seeks to prospectively demonstrate that Nasonex is better than placebo in     relieving nasal congestion in patients with seasonal allergic rhinitis.   "
220012|NCT00733018|"     Diet macronutrient relative composition, quality and quantity determines lifestyle disease,     including cardiovascular disease, development. Our hypothesis is that a high content of     carbohydrates in the diet contributes to increased insulin level. Moreover, activating     enzymes promoting inflammatory processes and possibly chronic disease development in the     body.   "
220014|NCT00733044|"     Background: Tinnitus is a common chronic health condition that affects 10% to 20% of the     general population. Among severe sufferers it causes disability in various areas. As a result     of the tinnitus quality of life is often impaired. At present there is no cure or uniformly     effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests an     integral multidisciplinary approach in treating tinnitus is effective. The main objective of     this study is to examine the effectiveness, costs, and cost-effectiveness of an integral     treatment provided by a specialized tinnitus center versus usual care. This paper describes     the study protocol.      Methods/Design: In a randomized controlled clinical trial 198 tinnitus patients will be     randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus     sufferers referred to the audiological centre are eligible. Included patients will be     followed for 12 months.      Primary outcome measure is generic quality of life (measured with the Health Utilities Index     Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus     cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the     number of patients to include is 198. Economic evaluation will be from a societal     perspective.      Discussion/ Conclusion: This is, to our knowledge, the first randomized controlled trial that     evaluates an integral treatment of tinnitus that includes a full economic evaluation from a     societal perspective. If this intervention proves to be effective and cost-effective,     implementation of this intervention is considered and anticipated.   "
220034|NCT00733304|"     This is a two month study to allow continued treatment with pazopanib eye drops. Study may be     extended to 5 months.   "
220035|NCT00733317|"     The purpose of this study is to determine if adding nebulized budesonide to the systemic     steroid for treatment of acute wheezing has any additive benefit in the emergency room.   "
220278|NCT00734994|"     Hypothesis: In selected patients external hyperthermia will be used in combination with     intravesical Mitomycin-C (MMC) to treat recurrent transitional cell carcinoma (TCC) of the     bladder after local resection and standard adjuvant therapy and thus prevent or delay     recurrence and the need for radical cystectomy.   "
220015|NCT00733057|"     Current antipsychotics have only a limited effect on two core symptoms of schizophrenia,     negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline     which has a beneficial effect in various neurological disorders. Recent findings in animal     models and human case-reports suggest its potential for the treatment of these symptoms of     schizophrenia. The current study aims to examine the efficacy of minocycline as add-on     treatment for alleviating negative and cognitive symptoms in early-phase schizophrenia. The     study will utilize a longitudinal double blind, randomized, placebo-controlled design with     patients followed for six-months. Early-phase schizophrenia patients were recruited and     randomly allocated to a minocycline or placebo treatment (2:1 ratio; 200 mg/day). The primary     outcome measures are the Scale for Assessment of Negative Symptoms (SANS) and assessments of     executive functions.   "
220016|NCT00733070|"     A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™     Guidewire for crossing chronic total occlusion in Coronary arteries.   "
220017|NCT00733083|"     The aim of this randomized, double-blind study is to compare parenteral pre-emptive     oxycodone, morphine and dexamethasone with placebo in the treatment of postoperative pain in     paediatric patients 4 to 12 years of age. The investigators hope to find out whether there     are any differences in postoperative pain and/or adverse effects among these groups.   "
220018|NCT00733096|"     Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and     worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2     concluded them to be effective in the long-term. In our own double-blind, placebo-controlled     study evaluating epidural etanercept, the results showed significant benefit in favor of the     etanercept group, but no subject was included with a duration of pain > 9 months, and the     results of this study have yet to be replicated.      Currently, epidural steroid injections are the most frequently performed procedures in pain     clinics across the U.S. However, epidural steroids may benefit only a select group of     patients. The literature on treating sciatica is notable for a lack of randomized comparative     studies involving various treatments. The objective of this project is to conduct a 3-arm     study to determine the efficacy of 1) transforaminal epidural corticosteroids; and 2)     transforaminal epidural etanercept, in patients with lumbosacral radiculopathy.   "
220019|NCT00733109|"     The aim of this study was to compare two management options for CIN 2. This randomized     clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as     CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women     subjected to follow-up at 3-month intervals for 12 months.   "
220020|NCT00733122|"     This study is designed to determine the tolerability and immunogenicity of a 3-dose regimen     of Gardasil administered to healthy married females between 16 and 23 years of age, in India.   "
220021|NCT00733135|"     This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™     plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in     treatment of moderate to severely calcified peripheral arterial disease in the superficial     femoral and/or popliteal arteries.   "
220022|NCT00733148|"     The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients)     aims to develop a low-risk monitoring and control device which allows maintaining metabolic     control in intensive care units. A system will be developed comprising three subsystems: a     body interface for the delivery of biofluids, biosensors for the determination of glucose     concentration in these biofluids and an adaptive control algorithm that generates advice and     thus represents a decision support system with respect to insulin infusion rate to establish     glycaemic control in critically ill patients. Within a closed loop system, intensified     insulin treatment will make use of the calculations leading to external regulation of     glucose.      It is the aim of this study to evaluate the correlation between arterial blood glucose     concentrations and interstitial fluid glucose concentrations in post surgery patients in the     Intensive Care Unit (ICU). Interstitial fluid glucose concentrations are based on     microdialysis in subcutaneous adipose tissue and calculated using the ionic reference     technique.   "
220023|NCT00733161|"     The purpose of this study is to determine the effect of passive exercise on systemic     endothelial function in elderly patients with chronic heart failure.   "
220024|NCT00733174|"     Subjects with impaired glucose tolerance will be randomized to either rosiglitazone or     placebo for a 18 month period. The study will look at baseline, 12 month and 18 month data     for exercise tolerance, coronary artery calcification and diabetes indicators.   "
220025|NCT00733187|"     To estimate the effect of food on the oral bioavailability and effect of diurnal variation on     the pharmacokinetics of ABT-869.   "
220026|NCT00733200|"     The investigators conducted a prospective study to determine the safety and efficacy of minor     and major hepatectomy selected by predetermined criteria in 138 patients with hilar     cholangiocarcinoma. In selected patients, minor liver resection was a good treatment.   "
220027|NCT00733213|"     A retrospective, registry analysis of the socio-economic and demographic characteristics of     patients suffering from locally advanced or metastatic prostate cancer, as well as the     depiction of the therapeutic algorithms followed in the Greek clinical practice.        -  Target Group: Patients with locally advanced or metastatic prostate cancer.        -  The first 10 consecutive patients records that meet the entry criteria.   "
220028|NCT00733226|"     The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on     respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of     attacks and effect on serum cytokine levels.   "
220029|NCT00733239|"     This study involves giving psychoactive drugs intramuscularly (injected into the muscle of     the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the     difference between one drug and another, as well as measuring the effects of the drugs on     mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each     subject will receive 2-4 of the listed interventions.   "
220030|NCT00733252|"     RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and     diagnose lung cancer or precancerous cells.      PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway     works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung     disease.   "
220279|NCT00735007|"     The Electronic Device - The RebiSmart™ is an electronic injection device that is being     studied for the delivery of Merck Serono's Rebif® New Formulation. The RebiSmart™ device is a     stand-alone hand-held device with internal power supply. It is used for subcutaneous (under     the skin) injections with single-use sterile disposable needles. The device will be kept in a     storage box and placed in the refrigerator after each use.      The key features of the RebiSmart™ are as follows:        -  Battery powered electromechanical automatic injector;        -  Automatic needle attachment and detachment;        -  Hidden needle before and after injection;        -  Injection can only be initiated by pressing the injection button when in contact with          the skin;        -  Automatic needle insertion and injection of the preset dose into the subcutaneous (under          the skin) tissue;        -  Adjustable injection comfort parameters: Injection depth, needle insertion speed,          medication injection speed and time that the needle remains in the skin ;        -  Cartridges with 3 doses of Rebif® New Formulation; and        -  Several other electronic functions including history (date and time) of cartridge          changes and injections.      The Study Drug - Rebif® New Formulation (RNF) Rebif® is a medicine that is part of a family     of proteins called interferon beta-1a (IFN-β-1a) molecules that play an important role in the     immune system and help limit the damage that occurs with multiple sclerosis (MS). The     interferon in Rebif® is like your body's own natural human interferon, but is made outside     the body by a process called recombinant DNA technology. Merck Serono International S.A.     (the maker of Rebif®) has recently updated the method to make Rebif®, and it is referred to     as Rebif® New Formulation (RNF).      For the purpose of this study, the form of Rebif® New Formulation (RNF) will differ slightly     from the one you currently receive. RNF will be supplied in pre-filled cartridges containing     three doses of 44mcg / 0.5 ml IFN-β-1a. This is the amount required for you to administer     during the course of one full week of treatment. The dosage of RNF 44mcg is injected under     the skin three times per week. The RebiSmart™ device will be provided for the administration     of RNF. RNF should be administered, if possible, at the same time (preferably in the late     afternoon or evening) on the same three days (e.g. Monday, Wednesday, and Friday), with at     least 48 hours break between each administration. You will be asked to record the time and     date of each injection in the diary cards provided. You will be taught how to properly use     the device to inject the medication. You will also be reminded to rotate injection sites and     advised on the importance of avoiding already inflamed areas for future injections.      The goals of this research trial are:        -  To evaluate if the electronic device can be used (if it is suitable) by MS patients          performing self-injections of Rebif® New Formulation.        -  To determine MS patients overall satisfaction of the new RebiSmart™ device by          determining their ease in using it, how often side effects happen (flu-like symptoms,          injection site reactions and any other overall injection issues) that they may          experience while on the trial. This will be done by completion of the Patient User Trial          Questionnaire and the Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ).        -  To evaluate specific features of the RebiSmart™ device from the answers MS patients          provide in the User Trial Questionnaire. The MS patient and the person who will trains          them on the proper use of the device will complete this questionnaire.   "
220036|NCT00733330|"     The primary objective of this investigation is to compare the precision of long leg alignment     achieved by the two types of procedure. The secondary objectives of this investigation are     to:      Compare the accuracy of long leg alignment achieved by the two types of procedure.      Compare the number of optimal implantations achieved by the two types of procedure.      Compare the clinical performance of the knee replacement in subjects who have undergone one     of the two types of procedure.      Compare the functional outcome achieved by subjects who have undergone one of the two types     of procedure.      Compare the interface radiographic appearance 5 years post-operatively between the two types     of procedure.      Compare the accuracy and precision of long leg alignment achieved by the two types of     procedure 5 years post-operatively, i.e., at final follow-up and also the change in accuracy     and precision between the final follow-up and baseline.      Compare the Adverse Events experienced by the subjects who have undergone the two types of     procedure.   "
220037|NCT00733343|"     The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of     adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart     failure due to left ventricular systolic dysfunction, already receiving optimal medical     therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea.     Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control     group is 35% in the first year. It is assumed that the hazard rate is constant over time.   "
220038|NCT00733356|"     This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of     Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to     detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on     reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be     between the ages of 6 and 12 at the beginning of the study.   "
220039|NCT00733369|"     The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a     greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in     primary TKA.      The secondary objectives of this investigation are to evaluate the clinical and patient     outcomes and survivorship associated with the DePuy P.F.C. Sigma RP-F and RP Posterior     Stabilised (PS) Knee over 5 years.   "
220040|NCT00733382|"     Dexamethasone is a safe and cheap abortive therapy for migraine headache. The effect of it is     never evaluate and not correlate with the effect of popular anti migraine medication such as     dihydroergotamine. The investigators proposal is to compare its effect with     dihydroergotamine.   "
220041|NCT00733395|"     The purpose of this study is to examine how certain kinds of fruit juice that contain natural     antioxidants and natural anti-inflammatory properties may reduce exercise-induced muscle pain     and injury. Participants will be recruited from registered participants in the Hood To Coast     Relay. The Hood To Coast Relay Race Officials will post the study on their website to find     interested teams. Interested participants will then be contacted by the study staff by phone     regarding the study's inclusion and exclusion criteria and to schedule the initial health     screening visit. The participants will undergo an initial health screening and survey about     muscle soreness, and then drink the investigational juice twice daily for 8 days. On the 7th     day of drink administration, the participants will report to the starting location of the     Hood To Coast Relay to meet with the investigators for 30 minutes to survey muscle pain and     juice tolerability. The participants will then participate in the Hood To Coast Relay,     drinking 2 more bottles of juice over the duration of the relay. At the conclusion of the     relay, the participants will meet with study investigators to take the same short survey     about muscle pain and juice tolerability.   "
220084|NCT00733954|"     This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate     Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in     Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one     of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate     ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.   "
220042|NCT00733408|"     This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle     (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib     hydrochloride work in treating patients with metastatic breast cancer. Drugs used in     chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, can prevent cancer growth by     blocking the ability of cancer cells to grow and spread. Erlotinib hydrochloride may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial     evaluates a maintenance treatment with erlotinib and bevacizumab after Nab-paclitaxel and     bevacizumab which may control cancer growth with biologic therapies.   "
220043|NCT00733421|"     The effects of none-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase     inhibitors (Coxibs) on the formation of bone and fracture healing have been a matter of     debate since long.      There is, however, limited data in humans and further prospective randomised studies are     warranted. Ekman et al studied in a prospective randomised double blind study the effects of     celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery.     They found significant effects on reduction of pain and need for opioid analgesics     postoperatively but could see no negative effects the numbers of none-unions at a 1-year     follow up 3.      In a similar prospective randomised double-blind study design significant effects in     reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the     perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative     effects could bee seen on six month follow-up of the strength of the reconstructed ligament.      The aim of the present study is to further study the effects of the perioperative use of     etoricoxib, a selective cox-II-inhibitor (Coxibs), in a prospective randomised double-blind     study on bone healing, pain and need for rescue analgesia in patients undergoing elective     Hallux Valgus surgery with a standardised surgical technique including an osteotomy of     metatarsale I and excision of exostosis.      Study population 100 American Society of Anesthesiology (ASA) physiological status1-2     patients scheduled for elective hallux valgus (HV) surgery      The patients are going to be randomised into 2 groups, 50 patients in each;        1. etoricoxib 90 mg once daily x 5        2. tramadol 100 mg twice daily x 5      First line rescue medication t. paracetamol 1 gr up to 4 gram daily Second line rescue t.     oxycodone 10 mg      Primary study variables:        -  X-ray evaluation (computer tomography (CT)-investigation) of bone healing assessed a          CT-scan modelling of the osteotomy at twelve weeks after surgery        -  Number of patients requiring rescue medication        -  Patient assessment using brief pain inventory 24 hours and 2 weeks after surgery      Secondary study variables are;        -  Visual Analogue Scale (VAS) grading Day 1-7        -  Compliance to base medication        -  Need for rescue analgesia Day 1-7        -  Adverse Effects             -  Experience of any emetic symptoms             -  Experience of any gastrointestinal symptoms        -  Satisfaction with pain medication Day 20        -  Wound dressing Day 20        -  Clinical evaluation 17 weeks, final assessment   "
220280|NCT00735020|"     This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside     mixing formulation of adjuvanted influenza vaccines.   "
220044|NCT00733434|"     Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so     it is used by some surgeons after microsurgery to keep the patency of the anastomosed small     vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep     vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 after head     and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases     postoperative vessel patency rate in patients undergoing head and neck microsurgery, with a     comparable complication rate as the control group.   "
220045|NCT00733447|"     The purposes of this study are to confirm that the Freedom Driver System is a suitable     pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers     can be trained to manage the Freedom Driver System safely outside the hospital.   "
220046|NCT00733460|"     Safety and dosimetry of BFPET™ will be evaluated in healthy volunteers and Coronary Artery     Disease (CAD) patients , male or female and of age ranging between 20-80 years old.   "
220047|NCT00733473|"     The purpose of this study is to determine if adding nebulized budesonide to the systemic     steroid for treatment of acute wheezing has any additive benefit in children who have     hospitalized for acute wheezing.   "
220048|NCT00733486|"     The primary objective of this investigation is to determine the survivorship of the LCS     Complete AP Glide mobile bearing knee prosthesis at 5 years.      The secondary objectives of this investigation are to evaluate the clinical performance of     the LCS® Complete AP Glide mobile bearing knee prosthesis and to determine its long-term     survivorship.   "
220049|NCT00733499|"     The primary objective of this investigation is to test the hypothesis that the Duofix Tibial     component results in a reduction of immediate postoperative pain compared to the LCS Porocoat     version.   "
220050|NCT00733512|"     To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons     throughout the United States.   "
220051|NCT00733525|"     This study will compare the medical and cost effectiveness of a stepped approach, including     self-help and drug therapies, to the current best available care for bulimia nervosa.   "
220052|NCT00733538|"     -  Assessment of survival without progression of stage I MM in two groups: arm A: simple          survey and arm B: administration of Zoledronate.        -  Describe different progression's type noticed and define the prognosis factors of a fast          evolution.   "
220053|NCT00733551|"     This study will evaluate the safety, tolerability and exposure of repeat escalating oral     doses of GSK962040.   "
220054|NCT00733564|"     Anesthesia during uterine curettage is a problem. Paracervical block is used in general for     such an operation, though, the anesthetic efficacy is incomplete. Propofol is the     short-lasting intravenous anesthetic administrated popularly. Sevoflurane is a new     inhalational anesthetic well-known for it's easy come, easy go property. The investigators     hypothesized that propofol, sevoflurane and paracervical block had different anesthetic     efficacy during uterine curettage. Which one is the optimal selection for such operation     needed to be evaluated.   "
220055|NCT00733577|"     This is an escalating dose study in subjects with T2DM, which will consist of four     overlapping cohorts receiving 6 days of SB756050 to assess safety, pharmacokinetics, and     pharmacodynamics.   "
220056|NCT00733590|"     The overall hypothesis of this study is that subtle interactions between structural     (substrate) and functional (trigger) abnormalities of the heart, some of which are     genetically-determined, can be used to identify patients at high risk of sudden cardiac death     (SCD). Such information may be used to better define patients most likely to benefit from     replacement of an internal defibrillator (ICD). The prospective, observational study to     enroll, categorize and follow patients who receive an ICD pulse generator replacement for     primary prevention of SCD (PROSe-ICD) was established to :        1. to gain a better understanding of the biological mechanisms that predispose to SCD        2. to develop readily determined clinical, electrocardiographic, genetic and blood protein          markers identify patients with an increased risk of dying suddenly   "
220937|NCT00746720|"     The purpose of this study is to test the hypothesis that orally administered etoricoxib     (COX-2) modulates prostaglandin and cytokine synthesis in the central nervous system (CNS)     and in the periphery in surgical patients and thus reduces pain and suffering.   "
220057|NCT00733603|"     There are many different treatments that doctors recommend for patients with IC/PBS. Only a     few research studies have been done to evaluate treatments given to patients. Treatment     choices can be of two types: drug therapy and non-drug therapy. The two treatments used in     this study will be of the non-drug therapy type. One of the treatments being used in this     study is called Myofascial Tissue Manipulation. This is a kind of physical therapy that is     designed to work on specific muscles and tissue layers in a particular part of the body. In     this study, this treatment will focus on the areas around the pelvis and the pelvic floor.     The treatment will involve the physical therapist's use of hands and fingers to target     specific muscles and tissues located within your pelvis, rectum, and/or vagina (the pelvic     floor) as well as muscles and layers of tissue in your abdomen and legs. The other treatment     being used in this study is Global Therapeutic Massage. This treatment involves the physical     therapist's use of classic Western body massage techniques on the muscles of your arms, legs,     hands, neck, shoulders, back, stomach, buttocks, and feet to create an overall feeling of     well being.      The purpose of this research study is to find out if Pelvic Physical Therapy is safe and     effective on treating symptoms in women with interstitial cystitis as compared to a full body     therapeutic massage. This study will also measure the lasting effects of the treatment up to     3 months after your last study treatment.   "
220058|NCT00733616|"     The purpose of the study is to determine efficacy and safety of combination therapy with     adjusted-dose docetaxel-oxaliplatin-capecitabine in patients with advanced gastric     adenocarcinoma and intermediate general status.(defined as ECOG 2 or weight loss 10-25% or     older that 70 years and no comorbidities nor functional dependency nor geriatric syndrome)   "
220087|NCT00733993|"     This study is being done to find out if medicines that affect a neurotransmitter (chemical     messenger) in the brain called adenosine improve behavioral problems that are related to drug     abuse. Another purpose of the study is to find out how genes related to adenosine change how     people respond to these medicines. More information about how these medicines change     behaviors may be helpful to come up with new treatments for drug abuse.   "
220059|NCT00733629|"     Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an     disease that leads to the development of dilated and fragile blood vessels. We propose to     culture endothelial cells from patients with HHT, to culture cells that express the proteins     mutated in HHT, namely endoglin and ALK-1. We will study the properties of these cells which     will involve their growth in different conditions and anticipate that DNA, mRNA and proteins     will be extracted from these cells for study of cell responses and association with     expression levels of endoglin and ALK-1. We hypothesize that these cells which express     half-normal endoglin or ALK-1 will show altered protein synthetic differences when compared     to normal white blood cells. We anticipate that that these findings may help to explain     aspects of the HHT disease phenotype.   "
220060|NCT00733642|"     The purpose of this study is to determine whether single doses of PF-04360365 is safe and     well tolerated in patients with Alzheimer's Disease.   "
220061|NCT00733655|"     Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an     disease that leads to the development of dilated and fragile blood vessels. We propose to     obtain small skin samples from patients with HHT in order to analyze the samples using     histological methods, and study the properties of vascular endothelial cells derived from     patients. We hypothesize that these cells will show altered growth, migration, and protein     synthetic differences when compared to normal endothelial cells, which may be confirmed in     single time point analyses in histological samples. We anticipate that that these findings     may help to explain aspects of the HHT disease phenotype.   "
220062|NCT00733668|"     An open-label, non-comparative, multi-centre, phase II prospective trial to assess the     efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors     (SSRIs) in SSRI-resistant major depressive disorder.   "
220063|NCT00733681|"     The purpose of this study is to evaluate the long-term clinical and functional performance of     the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine     whether the implant design results in a longer-lasting knee replacement.   "
220064|NCT00733694|"     To determine how the LCS mobile bearing knee system works within the Asian Population.   "
220065|NCT00733707|"     The purpose of this study is to determine whether there is increased oral contraceptive pill     (OCP) adherence in women receiving daily text messaging reminders to take their OCP, compared     to women who do not receive reminders. The investigators hypothesize that women who receive     daily text messaging reminders to take their OCP will have increased pill adherence compared     to women who do not receive reminders.      The investigators also hope to determine whether there is a difference in OCP adherence as     measured by electronic monitoring device and wireless real-time data collection versus     traditional patient pill diaries. The investigators hypothesize that electronic monitoring     device and wireless real-time data collection will demonstrate lower adherence compared to     traditional patient pill diaries.   "
220066|NCT00733720|"     The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg,     8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral     naltrexone. This study will provide data to support the design of a similar study of the     depot formulation of naltrexone and ultimately to study this combination for the treatment of     cocaine dependence.   "
220067|NCT00733733|"     One of the greatest problems in renal transplantation is the shortage of donor kidneys.     Kidneys of non-heart-beating donors (NHB) are a possible solution, but transplantation is     accompanied with a high percentage of acute renal failure, caused by ischemia-reperfusion     injury. The increased ischemia-reperfusion injury results in an increased immune activation,     which can lead to more injury of the kidney and additional acute rejections. The hypothesis     of this trial is that ischemia-reperfusion injury can be diminished by ATG. ATG could have     additional favourable effects. To investigate this half of the patients is treated with     additional ATG to the standard immunosuppressive treatment. Calcineurin inhibitors are not     diminished during the first days after transplantation to investigate whether ATG has special     effects on ischemia-reperfusion injury.   "
220068|NCT00733746|"     PURPOSE: This phase II trial is studying how well gemcitabine and erlotinib work when given     before and after surgery in treating patients with pancreatic cancer that can be removed by     surgery. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed. Giving these drugs after surgery may     kill any tumor cells that remain after surgery.   "
220069|NCT00733759|"     Pulmonary arteriovenous malformations (PAVMs) are thin-walled abnormal vessels which provide     direct capillary-free communications between the pulmonary and systemic circulations.     Patients with PAVMs have usually have low blood oxygen levels and are at risk of other     complications including strokes, brain abscesses, pregnancy-related complications and     haemorrhage. We hypothesise that the complications of PAVM patients arise from their PAVMs     and not the more recognised intracardiac forms of shunting. We propose to perform     echocardiograms to enable assessment of the presence of other causes of capillary-free     communications between the pulmonary and systemic circulations.   "
220070|NCT00733772|"     The purpose of this study is to determine whether daily supplement of 30 grams flaxseed is     effective in the treatment of metabolic syndrome (MetS).   "
220071|NCT00733785|"     The present pharmacokinetic study is designed to further characterise the pharmacokinetics of     the RSG XR formulation and aims to assess dose proportionality, strength equivalence, the     food effect and the pharmacokinetics after repeat dosing.   "
220072|NCT00733798|"     The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the     treatment of adult patients with progressive and/or recurrent malignant melanoma.   "
220088|NCT00734006|"     The aim of the proposed research is to measure the effect of drug-induced sedation on the     functional connectivity between brain regions as indicated by EEG signal transmission within     the human brain. The results of this study will help to identify the neurophysiological     correlates of changes in conscious experience that occur during drug-induced sedation.   "
220089|NCT00734019|"     The study will determine the survivorship of the fixed bearing P.F.C. Sigma knee with a     cobalt chrome tibial tray at 5 years.   "
220073|NCT00733811|"     Changes in chelation treatment and transfusion practices, during the past two decades, have     dramatically improved the prognosis of thalassemia major patients.Deferiprone (DFP) has been     compared with deferoxamine (DFO), using different schedules of treatment, in the majority of     the 13 clinical trials published between 1990 and 2008.No statistically significant     difference was shown between these two interventions during, at most, 18 months of     treatment.Three randomised trials that compared sequential DFP-DFO treatment versus DFO alone     reported controversial results but this could be due to small sample sizes and short     treatment duration. In fact, no trial with treatment duration longer than 18 months15, which     reported on mortality, adverse events, serum ferritin concentrations, as well as costs has so     far been published.      This long-term sequential DFP-DFO treatment versus DFP alone treatment trial was conducted to     assess the impacts of these chelation treatments on serum ferritin concentrations, mortality,     adverse events, and costs in thalassemia major patients.   "
220074|NCT00733824|"     This study will evaluate the safety and efficacy of intravenous AMD3100 added to a standard     G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for     lymphoma.      The investigators hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100, a     significantly higher proportion of lymphoma patients will collect ≥ 2 x 10E6 CD34+ cells/kg.   "
220075|NCT00733837|"     The purpose of this study is to determine the relationship between cervical multifidi     thickness, cervical spine proprioception and possible reflex activation of cervical multifidi     through stimulation of joint mechanoreceptors. Cervical mechanoreceptors will be activated     with an innocuous, nonspecific stimulation. Participants will have cervical spine     proprioception assessed through joint position sense testing. The multifidus muscle thickness     and activation state is to be assessed by sonography. These measures are done pre & post to     the innocuous stimulation. There is no specific hypothesis.   "
220076|NCT00733850|"     Gemcitabine is usually used to treat cancer of the pancreas. The purpose of this study is to     determine if Kanglaite Injection (KLT) is safe in patients with cancer of the pancreas, and     whether it improves the effectiveness of gemcitabine. Additionally, the effect, if any, of     KLT on the signs and symptoms of cancer as well as the common side effects of chemotherapy     will be evaluated.      The research drug, KLT, is purified from a traditional Chinese medicine called coix seed. It     is approved in China for use in combination with chemotherapy to treat patients with advanced     lung cancer and liver cancer. It is also approved in China for use by itself to treat the     symptoms of cancer in patients with advanced cancer of any kind. In the US, KLT is purely     experimental and is not approved for any use. While a small number of cancer patients in the     US have received KLT alone in a Phase I study, this is the first US protocol to evaluate     whether or not KLT is useful in pancreatic cancer.      This phase II clinical study was completed in the US in June 2014. The clinical study report     was submitted to the FDA in January 2015. The designs of the phase III clinical study for KLT     has been cleared by the FDA in May 2015 and will be launched soon.   "
220077|NCT00733863|"     This study will evaluate the safety and tolerability of repeated subcutaneous injections of     CAD106 in patients with mild Alzheimer's disease.   "
220078|NCT00733876|"     The purpose of this trial is to determine if the administration of allogeneic MSCs at defined     doses is safe in patients who are at high risk of developing significant Acute Kidney Injury     (AKI) after undergoing on-pump cardiac surgery.   "
220079|NCT00733889|"     The purpose of the study is to determine efficacy ans safety of the combination of cetuximab     and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant therapy followed     concomitant chemoradiotherapy (cisplatin) plus cetuximab in patients with a locoregional     esophageal carcinoma   "
220080|NCT00733902|"     Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.   "
220081|NCT00733915|"     The main objective of this study is to evaluate how the LCS Complete mobile-bearing total     knee system and surgical instrumentation performs.   "
220082|NCT00733928|"     The primary objective of this investigation was to evaluate & compare the performance of the     P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using     RSA.      The secondary objectives of this investigation are to evaluate the clinical and patient     outcomes and survivorship associated with the P.F.C. Sigma Knee Cruciate-retaining     all-polyethylene and metal-backed tibia components.   "
220083|NCT00733941|"     Individuals who participate in regular physical exercise possess a lower prevalence of     cardiovascular risk factors such as hypertension, type 2 diabetes, obesity and     hypercholesterolemia, and aerobic exercise is therefore considered an important adjuvant     therapy in risk factor modification and to promote health.      The main focus of the present study is therefore to detect how rapid it is possible to     increase aerobic capacity with interval running exercise.      The hypothesis is that it is possible to improve maximal oxygen uptake faster when increasing     training frequency. The total gain in maximal oxygen uptake will however be the same between     the two groups when they have performed the same amount of training   "
221495|NCT00743925|"     The objective of this study is to evaluate the safety and efficacy of A 002 when added to     high dose atorvastatin in subjects with an acute coronary syndrome (ACS)   "
220085|NCT00733967|"     The primary aim of the study is to determine the safety and tolerability of treatment with     Varenicline in methamphetamine-dependent volunteers. The investigators also seek to determine     the effects of treatment with Varenicline, as compared to placebo, on craving for     methamphetamine or cigarettes following exposure to methamphetamine and smoking cues,     respectively. The effects of treatment with Varenicline, as compared to placebo, on     subjective effects produced by administration of methamphetamine or placebo will be attempted     to be determined. Lastly, the investigators hope to determine the effects of treatment with     Varenicline, as compared to placebo, on reinforcing effects produced by administration of     methamphetamine or placebo.   "
220086|NCT00733980|"     This six-week study will evaluate the efficacy, safety and tolerability of GSK561679 compared     to placebo in female subjects with major depressive disorder   "
220090|NCT00734032|"     The primary objective of this study is to examine the effects of SB-480848 on plasma     lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a     4-week treatment with SB-480848.   "
220281|NCT00735033|"     The objective of this study was to investigate the effects of the Swiss ball on patients with     hemiplegia due to CVA.   "
220091|NCT00734045|"     The primary objective of the study is to establish the correlation between NT-proBNP     measurements in fresh human whole blood samples and those in plasma samples from the same     study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and     measured by the StatusFirst™ CHF NT-proBNP device in conjunction with the DXpressTM Reader in     a laboratory setting.   "
220092|NCT00734058|"     The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System     and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of     atrial fibrillation.      The study will test the safety and effectiveness of the EndoPhotonix™ Laser Ablation Systems     to photocoagulate cardiac tissue during cardiac surgery, to create electrical isolation of     the pulmonary veins and create other electrical isolation lesions in order to treat atrial     fibrillation. The surgical procedure will be conducted during concomitant mitral valve repair     or replacement surgery or in combination with other cardiac surgery including aortic valve     surgery, tricuspid valve surgery, or coronary artery bypass surgery.   "
220093|NCT00734071|"     The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily     (QD), in treating Generalized Anxiety Disorder.   "
220094|NCT00725413|"     The primary purpose of this study is to investigate the contraceptive efficacy, safety and     acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in     various countries in order to obtain country-specific data.   "
220095|NCT00725426|"     Study to examine whether rifampin has an effect on the pharmacokinetics of bosutinib.   "
220096|NCT00725439|"     This study is looking at a new oral drug to treat acne. All patients in the study will get     active drug, there is no placebo arm.   "
220097|NCT00725452|"     Prospective, open-label-, 1-arm, multicenter observational study to determine the dose and     interval of Infliximab infusions for subjects with plaque psoriasis.   "
220098|NCT00725465|"     The purpose of this study is to evaluate prospectively the usefulness of     IC-CO2(intraoperative colonoscopy (IC) using carbon dioxide (CO2)) in our colon and rectal     surgical practice, coincident with laparoscopic surgery, and assess whether it provides     useful information that influences the type of surgical therapy intended. We also wish to     further define the safety and extent of bowel distension when using IC-CO2. Furthermore, we     wish to evaluate the therapy and technique of using this combined approach to the treatment     of colorectal polyps and other localized, benign lesions of the large intestine. In this     study, the colonoscope is used both as a diagnostic and therapeutic tool, and is often used     in order to avoid a major bowel resection, yet effectively treat localized lesions of the     large intestine.      The hypothesis of this study is that IC-CO2 will provide useful information which does affect     surgical decision making at the time of operation, and that it is safe and does not result in     any significant bowel distention during or immediately after the procedure. We additionally     hypothesize that certain localized lesions of the intestines may be treated using a combined     laparoscopic-IC-CO2 approach to effectively treat the underlying disease, minimize risks to     the patient, and avoid a major bowel resection.   "
220099|NCT00725478|"     The aim of the non-interventional Post Marketing Study is to investigate the use of the     non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy     in patients with Morbus Parkinson. Tolerability and course of the disease or change of     parkinsonian symptoms during stabilisation on, or change over from other dopamine agonists     will be documented under routine conditions. Piribedil should be prescribed according to its     marketing authorisation by the responsible neurologist.   "
220100|NCT00725491|"     The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in     Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant     follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing     COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).   "
220101|NCT00725504|"     Our goals for this study involve using intravenous lidocaine as it is normally used in the     Stanford Pain Management Center to assess the effect of intravenous lidocaine on chronic     pain. Studies have been done determining the efficacy of intravenous lidocaine for treating     pain but little research has been done to determine the effects of an intravenous lidocaine     infusion on the different components of the pain experience. Our study will incorporate pain     quality measures both before and during the infusions of lidocaine to determine changes in     present pain intensity.   "
220102|NCT00725517|"     The purpose of this study is to evaluate the efficacy and safety of a 7.5% Icodextrin     peritoneal dialysis solution for once-daily long dwell exchange in patients undergoing     Continuous Ambulatory Peritoneal Dialysis (CAPD) in Chinese uremic patients.Patients were     divided into Dianeal group or Extraneal group for long dwell time. Net ultrafiltration, small     solute clearance and relationship between different transport group were used to evaluate     efficacy of Icodextrin. Physical examination, vital signs and laboratory tests were used to     evaluate safety of Icodextrin.   "
220103|NCT00725530|"     The purpose of this study was to measure lipid deposits on commercially marketed contact     lenses when worn on an extended wear (overnight) basis for 7 days.   "
220104|NCT00725543|"     This is a prospective, open-label, 1-arm, multicenter observational study to determine the     dose and time span of Remicade between infusions for ankylosing spondylitis (AS).   "
220105|NCT00725556|"     The purpose of this study is to evaluate the process of development of autistic children, in     a direct and indirect intervention context from mother´s response in Autism Behavior     Checklist.   "
220131|NCT00725920|"     The study is 12-week randomized placebo controlled trial compared to topiramate to treat     patients with posttraumatic stress disorder, according to DSM-IV criteria.      Patients will receive topiramate or placebo, the dose will start with 25 mg/day and every     week 25mg will be increment according to patients tolerance to side effects.      Patients will be evaluated by blind raters using Clinician-Administered PTSD Scale (CAPS),     Beck Depression Inventory (BDI) , Beck Anxiety Inventory (BAI), 36-Item Short Form Health     Survey (SF-36), Social Adjustment Scale (SAS).      the outcomes will be improvement on Posttraumatic Stress Disorder (PTSD), Depression,     Anxiety, quality of life and social adjustment scale according to scales above.   "
220132|NCT00725933|"     Safety and Tolerability of BIIB028   "
220106|NCT00725569|"     The planned study will be conducted in a prospective, randomized, double blind placebo     controlled manner. Two anti-traumatic Homeopathic remedies (Arnica montana and     Staphysagria) will be used. The selection of these remedies was based on a previous trial     that showed a statistical difference in Hemoglobin levels favoring pregnant women treated     with these drugs following delivery.      The proposed study will focus on the post-operative recovery of women undergoing Cesarean     section. According to Homeopathic principles, these two remedies are believed to improve the     vital force, and will therefore improve convalescence following surgery in the study group.     The study will include 90 women between the ages of 18 and 50 years who are scheduled for     elective Cesarean Section. Exclusion criteria are: obesity (above 100kg), malignancy,     psychiatric illness, diabetes and multipara pregnancies. Participants will be inducted     following a detailed explanation by an MD and signing of an informed consent form, and then     subdivided randomly into three groups numbering 30 in each: Two groups will be treated with     homeopathic drugs of varied doses, and the third will get a placebo remedy which is     indistinguishable from the other drugs. Outcome measures will include: 1. Blood loss - as     estimated by a reduction in serum Hemoglobin levels. 2. Pain -to be evaluated by a numerical     rating score (NRS) 3. Analgesic use 4. Length of post-operative stay and complications. 5.     Quality of life outcomes - to be assessed using the MOS SF-36 questionnaire at one and four     weeks following surgery. Although not expected, adverse events will be monitored.      If, as we anticipate, the homeopathic treatment proves to be both safe and effective in     shortening the duration of post-operative healing, this will have significant implications,     with respect to both healthcare costs and patient suffering. It will also open the door for     further research in the field of trauma medicine, as well as other stress-related illness.   "
220107|NCT00725582|"     The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on     airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given     as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a     screening period and a treatment period which includes doses on day 1 and day 8.   "
220108|NCT00725595|"     The overall purpose of this study is to determine the effects of adaptive servo ventilation     (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of     breathing characterized by hyperpneas followed by hypopneas and or apneas. Clinically, the     physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced     exercise capacity and possibly ventricular arrhythmias. The intent of the proposed     intervention is to compare the efficacies of ASV and Bi-level ventilator on CSR.   "
220109|NCT00725608|"     The purpose of this study is to evaluate the acceptability and safety of switching to     Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication     dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to     study enrollment and who are willing to participate, will initiate therapy on Day 1 of the     study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and     determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will be     collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of     Month 12.   "
220110|NCT00725621|"     This is a prospective, open-label, 1-arm, multicenter observational study to determine the     average Remicade dosage and time span between 9 infusions in subjects with rheumatoid     arthritis (RA)   "
220111|NCT00725634|"     Phase 1 study to determine safety, tolerability, dose-limiting toxicities (DLTs), and     recommended Phase 2 dose of AV-299 administered IV as monotherapy to patients with relapsed     or refractory solid tumors, lymphoma, or multiple myeloma. The study will also determine the     safety, tolerability and DLTs of AV-299 in combination with erlotinib in patients with     relapsed or refractory solid tumors.   "
220112|NCT00725647|"     Premature babies are affected by a condition known as patent ductus arteriosus in which the     ductus arteriosus (a normal structure) fails to close after birth as it should. A very large     ductus can put extra strain on the heart and lungs, making the baby's breathing dependent on     a mechanical ventilator. Attending physicians can close the duct with medical\or surgical     treatment but assessing whether this is justified can be difficult. The physician usually     bases this decision on assessment of the baby's general condition and an ultrasound     evaluation of the heart (called an echocardiogram) but the last is particularly dependent     on availability of skilled operators.      The investigators have examined whether blood levels of a hormone called B-type natriuretic     peptide (Nt pro-BNP)in the first week of life predict the need to treat a ductus arteriosus.     This hormone is produced by the heart if it is under strain. If the test is helpful it could     reduce dependence of physicians on echocardiography by skilled operators.      Babies who were recruited had blood samples collected on days 1, 2, 3 and 7 for measurement     of Nt pro-BNP. Each baby also had an echocardiogram performed between the fifth and seventh     day of life. Decisions about treatment of the duct were made by attending physicians     independent of the study. Physicians, investigators and echocardiographers were blinded to     knowledge of the Nt pro-BNP concentration. Nt pro-BNP was also measured before and after     treatment in all babies who had a PDA treated and echocardiography performed to confirm     closure.      Receiver operating characteristics (ROC) curves were used to assess the predictive value of     Nt pro-BNP for samples collected at each time point. The investigators also compared the Nt     pro-BNP levels in samples collected before and after treatment to assess the usefulness of Nt     pr-BNP as an indicator of duct closure.   "
220125|NCT00725842|"     The objective of this study is to determine the relapse rate in the French patient population     with chronic hepatitis C (CHC) previously treated with PegInterferon Alfa-2b (Peg-IFN     alfa-2b) plus Ribavirin according to standard clinical practice. Treatment was to be     completed prior to the enrollment in the current study. The study will also aim to identify     factors that are predictive of relapse. Relapse rate is defined as the percentage of patients     with negative viral load at end of treatment who again have positive viral load at 6 months     after the end of treatment.   "
220126|NCT00725855|"     The purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50     sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize     the P50 ratio.      Data produced in this study will provide useful information regarding the value of P50 as an     efficacy biomarker, and provide evidence for the optimal dosing of MEM 3454 for additional     P50 studies.   "
220113|NCT00725660|"     BACKGROUND: Pre-eclampsia complicates about 2% of pregnancies. It accounts for at least 50     000 maternal deaths per year worldwide and is the second most common cause of maternal death     in the developing world. Also, Pre-eclampsia is the commonest cause of iatrogenic     prematurity, It frequently coexists with intrauterine growth restriction (IUGR) and placental     abruption, other important causes of adverse prenatal outcome.      There have been many studies investigating whether the disease can be prevented. In order to     achieve this, one needs to be able to identify firstly those women that are at highest risk     of the disease.      Early studies showed that impedance to flow in the uterine arteries decreases with gestation     in normal pregnancies, while in pregnancies with established pre-eclampsia or IUGR the     impedance is increased.      These observations led to a number of screening studies in the second trimester, which     assessed if it is possible to predict those pregnancies destined to have complications of     impaired placentation. These studies showed that women with increased impedance to uterine     artery blood flow have an increased risk of developing pre-eclampsia, and detection can be     further increased by using angiogenic factors (That are involved in the pathogenesis of Pre-     eclampsia and could be useful for early prediction of the disease: VEGF, PIGF, PP13, sFLT1)     in combination with uterine arteries Doppler study in the second trimester.      METHODS: In this study we would like to add uterine arteries Doppler to the early routine     detailed ultrasound examination (14-16 weeks), in 3000 women in Jerusalem. in addition we     would like to check angiogenic factors from the serum blood taken for the routine triple test     in these women (16-18 weeks).pregnancy outcome would be collected after labour from the     medical centers participating in this research.   "
220114|NCT00725673|"     Patients with COPD have been found to have an increased risk of osteoporosis. The underlying     mechanism is not clear yet. This case control study aims to identify risk factors for     osteoporosis in GOLD II COPD patients. COPD GOLD II patients with osteoporosis (cases) will     be matched by gender and age to COPD GOLD II patients without osteoporosis(controls).      Possible risk factors for osteoporosis are:        -  BMI/VVMI (body composition)        -  emphysema vs chronic bronchitis        -  physical capacity        -  Use of certain medication (eg corticosteroids, SSRI's)        -  Nutritional status        -  Infectious parameters Outpatients from the pulmonary ward of the Catharina Hospital          Eindhoven with GOLD II COPD according to the ATS and GOLD-guidelines will be included in          the study (after written informed consent).      A DEXA-scan will be made, if patients are osteoporotic or have a normal BMD they will be     included in the study.      A HRCT will be made, a six minutes walking distance will be performed, blood will be drawn     for lab. analysis, an X-ray of the vertebral collum will be made, impedance will be measured     and hight and weight will be measuered. Also patients will fill in a questionaire.      By univariate and multivariate analysis the collected data will be analysed to determine     possible risk factors for th development of osteoporosis in COPD GOLD II patients.   "
220115|NCT00725686|"     The aim of the study is to evaluate whether PF-04523655 is safe in the treatment of     neovascular/wet AMD   "
220116|NCT00725712|"     This clinical study is being conducted at multiple sites to determine the best confirmed     response rate, safety, and tolerability of GSK1363089 treatment in metastatic gastric     carcinoma.   "
220117|NCT00725725|"     The purpose of this study is to evaluate the effectiveness of Org 25935 vs. placebo given in     combination with cognitive-behavioral therapy (CBT) to reduce the symptoms of panic disorder.     It is hypothesized that treatment with Org 25935 at a dose of 4 mg or 12 mg will differ     significantly from placebo with respect to the Panic Disorder Severity Scale (PDSS) total     score over 3 weeks of therapy.   "
220118|NCT00725738|"     The purpose of this study is to evaluate the ejection fraction (EF) increase at 6 months     follow up and major adverse cardiovascular events (MACE) after intracoronary autologous stem     cell transplantation in ST elevation myocardial infarction patients versus a control group.   "
220119|NCT00725751|"     Although injection drug users represent the majority of new and existing cases of infection     with hepatitis C virus (HCV), many lack access to treatment because of concerns about     adherence, effectiveness, and reinfection. On the basis of a small but growing body of     evidence showing that injection drug users can undergo treatment for HCV infection     successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance     users be treated for HCV infection on a case-by-case basis. In this study, all patients will     receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European     labeling; one cohort of participants will also be receiving substitution therapy (opioid     medicines with long-lasting effects [methadone + buprenorphine] or morphine).   "
220120|NCT00725764|"     This study is being conducted to determine the best confirmed response rate, safety, and     tolerability of GSK1363089 treatment in adult subjects with squamous cell carcinoma of the     head and neck (SCCHN). GSK1363089 is a new chemical entity that inhibits multiple receptor     tyrosine kinases (RTKs) with growth-promoting and angiogenic properties. The primary targets     of GSK1363089 are the HGF and vascular endothelial growth factor (VEGF) RTK families (eg,     MET, VEGFR2/kinase insert domain receptor [KDR]). Since MET overexpression has been     associated with poorer prognosis and MET tyrosine kinase mutations have been reported in     SCCHN, inhibition of MET receptor and VEGFR2/KDR activation by agents such as GSK1363089 may     be of therapeutic benefit in this patient population.   "
220121|NCT00725777|"     Patients with non-falciparum infection will be given artemether-lumefantrine for three days     and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on     immunology will be performed.   "
220122|NCT00725790|"     The purpose of this study is to determine if 12 weeks of flexible-dose vardenafil therapy     demonstrates superior efficacy compared to placebo in subjects with ED solely secondary to a     traumatic spinal cord injury   "
220123|NCT00725803|"     The purpose of this study is to examine the safety, tolerability, pharmacokinetics (studies     how the body processes a drug), and initial activity of GS-9450 in preventing liver damage     due to scarring, or fibrosis, caused by Hepatitis C Virus (HCV) infection.   "
220124|NCT00725829|"     The aim of the current study is to evaluate whether treatment with high doses of simvastatin     can reduce coagulation activation in patients with acute coronary syndromes and if ezetimibe     in conjunction with simvastatin may affect blood clotting in a similar manner.      The investigators hypotheses are as follows:        1. Intensive lipid lowering treatment with simvastatin (40 mg/day) and simvastatin (40          mg/day) combined with ezetimibe (10 mg/day) initiated after acute coronary syndrome          leads to attenuation of blood coagulation including reduced thrombin generation,          thrombin-mediated coagulant reactions, and improved structure of plasma clots.        2. Anticoagulant effects of simvastatin are weaker than those observed during          administration of simvastatin and ezetimibe.   "
220157|NCT00726284|"     The purpose of this patient registry is to prospectively collect data on patients who are     having spinal surgery with EBI and Interpore Cross Spine Products.   "
220127|NCT00725868|"     In stent restenosis and myocardial infarction are have been linked the balance between injury     and healing of the endothelium These processes can be measured respectively using the number     of circulating endothelial cells and endothelial progenitor cells. We therefore aimed to     evaluate the relationship between the balance of injury and healing of the endothelium at the     time of PCI and major adverse cardiovascular events including death, myocardial infarction     and target lesion revascularization at 6 and 12 months follow-up.   "
220128|NCT00725881|"     The purpose of this study is to evaluate the safety and pharmacokinetics of multiple,     once-daily, intravenous doses of trans sodium crocetinate (TSC). The effectiveness of TSC in     alleviating the symptoms of intermittent claudication (IC) will also be assessed.   "
220129|NCT00725894|"     The purpose of this multi-center prospective clinical outcomes study is to determine validity     and safety of the pediatric locking nail for femoral fracture management in children with     open physes.   "
220130|NCT00725907|"     PRP will enhance ATFL tears healing by time and quality.   "
220133|NCT00725946|"     This is a pilot imaging study for women whose tumors express NIS [Na+I- symporter, sodium     iodide symporter]. Eligibility is limited to the presence of strong (3+) and/or plasma     membrane staining in > 20% of cells as determined by immunohistochemical methods. A total of     10 patients will be imaged with 124I PET/CT (serial scans over 24 hour period) to determine     radioiodide uptake and distribution in tumor tissue. Thyroid iodide uptake and retention will     be blocked beginning one week prior to 124I PET/CT scan with thyroid hormone (T3) and     methimazole (impedes organification). Tumor, organ and whole body dosimetry will be     calculated in each patient.   "
220134|NCT00725959|"     In this randomized controlled trial, we will identify social networks on My Space.com, an     randomly assign each network to control or intervention status. We will then intervene at the     level of the network with dynamic, interactive HIV prevention messages (intervention) or     static messages about HIV prevention (control). We will develop the intervention content with     input from our target audience (My Space.com users) and will measure baseline, and 3 and 6     month assessments of condom use and abstinence among all participants   "
220135|NCT00725972|"     Several recent clinical trials have documented that early aggressive resuscitation approached     guided by defined hemodynamic variables using thoughtful protocols may improve outcome. The     concept underscored by this newer trial was that appropriate resuscitation prevents     subsequent tissue injury even if overt shock is present, if the resuscitation is carried out     early enough.   "
220136|NCT00725985|"     A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of     oral cladribine versus placebo in subjects who had a first clinical demyelinating event     (clinically isolated syndrome). Subjects in either the cladribine or placebo group may also     enter treatment periods with open-label interferon-beta or open-label cladribine depending     upon the disease status. The primary objective of this study is to evaluate the effect of two     dosage regimens of oral cladribine versus placebo on the time to conversion to multiple     sclerosis (MS) (from randomization) according to the Poser criteria in subjects with first     clinical demyelinating event at high risk of converting to MS.   "
220137|NCT00725998|"     Introduction: In Cochlear Implant (CI) users, the recording of the electrically evoked     compound action potential (ECAP) of the auditory nerve represents an option to assess changes     in auditory nerve responses and the interaction between the electrode and the neural tissue     over time.      Aim: To study ECAP in children during the first year of CI use.      Material and methods: The ECAP characteristics have been analyzed in 13 children implanted     younger than three years old. SERIES STUDY.      Descriptors:      Cochlear Implantation,cochlear nerve,child.   "
220138|NCT00726011|"     Different pathophysiologic mechanisms are responsible for the development of chronic pain     disorders. Pain pathways are triggered in part by ectopic discharges of voltage-sensitive     sodium channels, which are in abundance in both the peripheral and the central nervous     systems. Tetrodotoxin (TTX) is a selective blocker of Na+ channels and causes analgesia     either by decreasing the propagation of action potentials by Na+ channels and/or by blocking     of ectopic discharges associated with chronic pain. TTX is extracted from the puffer fish     (fugu). Results from animal pharmacology studies revealed that TTX is a more potent analgesic     than standard analgesic agents such as aspirin, morphine or meperidine.      At present, the management of severe cancer pain generally includes the use of opiates. This     can often result in undesirable side effects, and treatment with this type of medication is     not always effective. Because currently available pain-relieving therapy is unsatisfactory     for many patients, there is a need for new therapeutic approaches for the management of     moderate or severe cancer pain.      Recent studies indicate that intramuscular (into a muscle) or subcutaneous (under the skin)     injections of tetrodotoxin (TTX) may reduce pain in cancer patients who did not respond to     standard therapies.      The current proposed study (TEC-006OL) is designed to provide the option for all patients who     participated in the TEC-006 study (both tetrodotoxin and placebo-treated) to receive or     continue to receive tetrodotoxin treatment.   "
220139|NCT00726037|"     This study is designed to determine the duration of T reg suppression in patients with     metastatic pancreatic cancer receiving Ontak. The goal is to define the optimal time for     future dendritic cell vaccine administration.   "
220158|NCT00726310|"     The purpose of this open, multi-center study is to prospectively collect outcome data on     patients who are having lumbar spinal fusion surgery with implantation of the SpineLink®     system.   "
220938|NCT00746733|"     The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR     with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how     much of the drug is absorbed into the body.   "
220140|NCT00726050|"     This study will use repetitive transcranial magnetic stimulation, or rTMS (magnetic     stimulation to the brain), to examine how the brain distinguishes between two signals that     are spaced very closely in time. The ability to tell the difference between sensory signals     is important to understanding sensory input. Understanding how this works may help to develop     new treatments for sensory deficits.      Healthy volunteers 18 years of age and older may be eligible for this study. Participants     undergo the following procedures during three visits to the NIH Clinical Center:      rTMS - all visits (sham rTMS on one visit) :      For TMS, a wire coil is held on the scalp. A brief electrical current passed through the coil     creates a magnetic pulse that stimulates the brain. During the stimulation, the subject may     be asked to tense certain muscles slightly or perform other simple actions.      Theta burst stimulation (TBS) - all visits (sham TBS on one visit):      Same as TMS, but brief pulses of electrical current are passed through the coil. Subjects     undergo intermittent TBS on one visit and continuous TBS on another.      Somatosensory evoked potential (SEP) - all visits:      SEP tests how sensory information travels along the nerves to the spinal cord and brain. A     small metal disk electrode placed on an arm delivers a small electrical shock. Electrodes     placed on the scalp record how the impulse travels over the nerve pathways to the cerebral     cortex of the brain. EEG (see below) records what sensory information the brain is detecting     and processing. Paired-pulse SEP is done before and after TBS.      Temporal discrimination threshold - all visits:      This test investigates the brain's ability to discriminate sensory information. Electrodes     are placed on the subject's wrist. Two electrical pulses are delivered to the nerve at the     wrist at different spaced intervals to determine when the subject feels the two pulses are     fused into one. This test is done before and after TBS.      Electroencephalography (EEG) - all visits:      This test records brain waves (electrical activity of the brain). Electrodes are placed on     the scalp with an electrode cap. The spaces between the electrodes and the scalp are filled     with a gel that conducts electrical activity.   "
220141|NCT00726063|"     This study will evaluate the contributions of the Nanotite implant design when used by     graduate students in their first year of placing implants.   "
220142|NCT00726076|"     The purpose of this study is to test a computer program for people with epilepsy. The program     was developed to help people with epilepsy improve their self-management skills for taking     medications, reducing stress, and sleeping well.   "
220143|NCT00726102|"     Inadequate feeding of infants and toddlers impairs physical and cognitive development and is     a major contributor to early childhood infectious disease illnesses and preventable     mortality. Optimal feeding has two broad components: Exclusive breast feeding (EBF) for the     first-6 months followed by continued breast feeding accompanied by complementary foods (CF)     that is adequate in quantity and quality. While EBF is theoretically straightforward, CF is     more complex. This is because CF is typically limited mainly or entirely to plant-based foods     in developing countries worldwide. Dependence on adequate, affordable locally-produced foods     for complete CF requires an inexpensive, regular source of meat especially to provide     'problem' micronutrients, notably, but not only, zinc and bioavailable iron. While the use of     micronutrient-fortified CF and of supplements, including SprinklesTM, is spreading, their     efficacy largely remains uncertain as does their availability, particularly on a sustainable,     affordable basis Achievement of the widespread regular use of meat as a CF requires: (1)     adequate local production of affordable small scavenging/foraging animals in poor rural and,     where feasible, periurban communities worldwide; (2) effective communication for behavioral     change/education so that young children, starting at age 6 months (when meat is readily     accepted by infants), receive priority in the use of this meat. Solid scientific evidence of     the value of international/national programs to achieve this goal is essential to provide the     basis and incentive for major international and national programs to promote the feeding of     meat as an early and regular CF. The acquisition of such evidence is the goal of this study      The intervention to be evaluated is meat fed daily as a complementary food from age 6-18     months. Thirty infants-toddlers in each of 60 rural communities (total of 1,800 subjects)     will participate. In a cluster design, twenty communities (test) will be randomized to     receive meat,twenty communities (control) will receive a plant recipe providing the same     amount of calories, twenty communities (fortified cereal) will receive a commercially     available fortified cereal providing the same amount of calories. This project will be     located in rural China in a county where high quality collaboration is already established,     and where we have recently demonstrated inadequate bioavailable zinc intake and zinc     deficiency in toddlers. We have also found a high (30%) incidence of stunting, now widely     used as an indirect indicator of populations with zinc deficiency. Other advantages of this     location include the willingness of doctors located in each rural community to provide the     test or control meal 7 days per week in their homes and the absence of any access to     supplements / fortified products which could complicate interpretation of data. The young     children in the test communities will receive certified safe lean pork 7 days per wk.     Starting with a very small quantity at 6 months, the quantity of lean pork will be increased     as infants are ready to take more up to a plateau of 2 oz/d. No subsequent increases are     planned because neither zinc nor iron requirements increase from 6-11 months to 12-18 months.     Lean pork will be used because pigs are ubiquitous in China and can be maintained cheaply by     scavenging/foraging on waste materials adjacent to human habitation. Test and control     clusters will also receive nutrition education to achieve maximal diversification of locally     available affordable foods. Longitudinal outcome measures include indices of physical growth,     especially length; infectious disease incidence and prevalence; cognitive development; zinc     and iron intake and biomarkers for these and other micronutrients. Zinc absorption will be     measured. Data will flow daily from communities to the district hospital in Xi-Chou, weekly     to the data manager in Shanghai and 3-monthly to the Data Monitoring Safety Board (DSMB) and     to the University of Colorado research group.   "
220144|NCT00726115|"     The main objectives of this study is to assess the safety and tolerability of ascending     single and multiple oral doses of SAM-531 in healthy subjects   "
220146|NCT00726141|"     Despite rising smoker rates, particularly in girls and young women, only few studies have     focused on smoking cessation in young smokers. Gynaecologist practices may be an ideal     setting to proactively intervene with young female smokers. Elevated health risks of smoking     while using hormonal contraceptives could be a successful approach to gain young women's     attention on smoking cessation. The purpose of this study is to evaluate the effectiveness of     a smoking cessation intervention for girls and young women visiting gynaecologist practices     and using hormonal contraceptives.   "
220147|NCT00726154|"     The objective of this pilot study is to test the feasibility of a larger planned trial. The     objective of this larger trial will be to determine the extent to which aspects of circadian     rhythmicity, including, sleep/wake rhythms, daily social routines (i.e., social rhythms),     circadian type (morningness/eveningness), endogenous circadian rhythms and polymorphisms     associated with altered circadian function in specific genes (namely, CLOCK, Period 2 and     Period 3) moderate treatment response in bipolar disorder.   "
220148|NCT00726167|"     The purpose of this study is to test a new method for diagnosing and monitoring     Ventilator-Associated Pneumonia, which is a major killer among ICU patients. The method     requires analysis of a small amount of the patient's blood for concentration of a hormone     called Procalcitonin.   "
220149|NCT00726180|"     The majority pf breast cancers present as ER-positive, many of which are able to be targeted     with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has     the potential to benefit patients by making hormonal therapies a therapeutic option and     possibly improving their overall prognosis.   "
220150|NCT00726193|"     The purpose of this clinical outcomes collection study is to analyze the effect of the EBI     OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no     visible progressive signs of healing) fracture in a prospective database.   "
220151|NCT00726206|"     The general movement and the electroencephalogram analysis of the preterm have a high     predictive value of the neuro-developmental outcome of the infants.   "
220152|NCT00726219|"     This study is designed to compare femoral perineural catheter insertion distances, in order     to help determine which is the best for pain relief after knee surgery.      Hypothesis: the quality of the femoral nerve block will not be inferior if the catheter is     inserted deeper (7cm compared to 3 cm)   "
220153|NCT00726232|"     To evaluate the safety and efficacy profile of different treatment regimens of Ruxolitinib     (INCB018424) administered to two groups of patients; those with polycythemia vera (PV) and     those with essential thrombocythemia (ET). Patients in each group will be refractory to     hydroxyurea or for whom hydroxyurea is contraindicated.   "
220154|NCT00726245|"     the improvement of symptoms and disease progress by the treatment of OA of the knee with PRGF   "
220155|NCT00726258|"     Thoracotomy for lung resection is deemed painful. Ketamine is now a renewed interest in     preventing acute postoperative pain. A previous study performed in the service testing the     association ketamine/morphine versus morphine PCA, postoperative, for patients who do not     benefit from postoperative epidural thoracic surgery, has demonstrated a reduction of     postoperative pain associated with a reduction of nocturnal arterial desaturation following     surgery when ketamine was added to morphine.   "
220156|NCT00726271|"     An innovative dietary approach to obesity, based on the set-point theory of body weight and     associative learning, was developed by Seth Roberts. Roberts's approach focuses on     dissociating flavor and calories by consuming small amounts of very bland but calorie-dense     foods such as extra-light olive oil between meals. Roberts believes that the dissociation     between flavor and calories lowers the body weight's set point, suppressing appetite and     thereby inducing weight loss without causing hunger. Studying the feasibility of this     approach is particularly relevant to patients taking drugs that cause increased appetite and     weight gain as a side effect, as increased hunger makes the usual calorie restriction     approach even more difficult than it normally is. Low-income people have a diet higher in     prepackaged standardized foods, which may be one contributing factor to their higher risk of     developing obesity.      Specific Aims        -  To test the acceptance of, and the patients' compliance rate to, the Shangri-La Diet        -  To ascertain whether a controlled clinical trial of the Shangri-La Diet would be          feasible.        -  To see if the weight loss documented anecdotally in many people is reproducible in          patients from low-income areas who are overweight and taking prescribed medications          associated with increased appetite and weight gain.      Analysis: The primary end point will be acceptability of the dietary intervention as measured     by the final interview and the evaluation form—is this something patients would be willing to     do over the long term? This will help determine whether a controlled trial of the dietary     intervention would be feasible, and provide information needed to design such a trial.     Secondary outcomes will be changes in the participants' weight, waist measurements, anxiety,     and depression scores   "
220159|NCT00726323|"     This clinical study is being conducted at multiple sites to determine the best confirmed     response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell     carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic     forms; subjects with either classification will be accepted into this study.   "
220160|NCT00726336|"     A study in healthy volunteers to determine whether there is a drug interaction between     GSK1349572 and tenofovir   "
220161|NCT00726349|"     The objective of our research program is to determine the transfusion threshold required to     maximize functional recovery after major orthopedic surgery (total hip/knee replacement) in     these, most often, elderly patient with serious comorbidities.      Hypothesis: we hypothesize that a threshold hemoglobin concentration exists below which     functional recovery becomes difficult, even if the vital prognosis of patients is not     impaired.   "
220162|NCT00726362|"     The primary objective is to survey the efficacy of various commercially available statins (a     class of lipid-lowering agents, for example, rosuvastatin, atorvastatin, simvastatin,     lovastatin, pravastatin and fluvastatin) under local clinical practice in treating patients     with hyperlipidemia. Surveillance data (Lipid Profile) will be collected during course of     usual clinical practice or captured upon its availability.   "
220175|NCT00726544|"     The purpose of this ascending-dose research study is to determine whether the administration     of ARC1779 Injection improves subject's health profile by protecting the brain, heart, and     kidney from damage due to formation of small blood clots in blood vessels. It will also     determine the safety of ARC1779 Injection, how ARC1779 Injection enters and leaves the blood     and tissue over time, and its effect on laboratory tests related to blood clotting, heart and     brain function, and other body systems.   "
220282|NCT00735046|"     A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive     behavioral therapy for patients with early dementia.   "
225398|NCT00802646|"     The purpose of this study is to determine if the epidural of local anesthetics has an effect     on fever that may occur in first time mothers during labor.   "
220163|NCT00726375|"     This is a clinical trial to see if treatment with etanercept for early skin graft-versus-host     disease (GVHD) can effectively treat and prevent progression of the disease without using     high dose steroids.      GVHD is a common complication following a bone marrow transplant from another donor. GVHD     occurs after transplant, when the donor's blood cells (called lymphocytes) recognize parts of     your body, such as the skin, as foreign. A certain chemical, called Tumor Necrosis Factor, or     TNF, also causes damage to the skin. The main effect on the skin is a red rash, when the skin     GVHD is mild, but in more severe forms the skin can blister.      We have been studying GVHD at the University of Michigan for the past decade. We know that     high levels of TNF makes GVHD worse. Our research has shown that adding an anti-TNF drug     (called etanercept or Enbrel®) to the standard GVHD treatment of high dose steroids leads to     improvement in the GVHD in twice as many patients compared to when steroids alone are used.     It is now standard practice at the University of Michigan and many other centers to treat     GVHD with both steroids and etanercept.      The management of early skin GVHD for most patients involves treatment with steroids, given     both as a cream and by either the mouth (in pills) or IV. Early skin GVHD is also called     grade I GVHD, which means the skin rash covers less than half of the body. Steroid treatment     can be effective; however, it also causes many complications such as an increased risk of     infection, weight gain, stomach ulcers, muscle weakness and bone damage, among many others.     We have developed this study to test whether starting treatment with etanercept and steroid     creams alone can treat the GVHD without requiring the use of high dose steroids. The goal is     to avoid the complications that come with high dose oral or IV steroid treatment. The high     dose steroid treatment would only begin if your GVHD got worse.   "
220164|NCT00726388|"     This is an open-label, multiple-dose, safety study of DIC075V in patients with acute     post-operative pain following abdominal or orthopedic surgery.   "
220165|NCT00726401|"     You are being asked to take part in a research study of COLD-fX, a product designed to boost     the immune system. COLD-fX is an extract from the roots of North American ginseng and it may     offer some benefit to people with seasonal allergies.      The purpose of the present study is to find out how effective and safe COLD-fX is in     improving quality of life and reducing symptoms of seasonal allergies such as hay fever.     COLD-fX is not yet approved for treatment of seasonal allergies. We are seeking to enroll 200     participants in the Capital Health region.   "
220166|NCT00726414|"     The purpose of this study is to evaluate and compare the relative bioavailability of Quinine     Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed     conditions.   "
220167|NCT00726427|"     The purpose of this study is to assess safety and tolerability of AZD1656 after single     ascending oral doses in healthy male subjects   "
220168|NCT00726440|"     The Capteur Evadiac study group, composed of French and Belgian diabetologists, has     designed a 1 year randomized controlled multicenter study in order to define what should be     the best clinical way of using continuous glucose monitoring in the long term to improve     metabolic control in uncontrolled type 1 diabetes patients.   "
220169|NCT00726453|"     The objective of the study is to assess the safety and effectiveness of the Resolute     Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native     coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.   "
220170|NCT00726466|"     Efalizumab is an immunosuppressive recombinant humanized IgG1 monocolonal antibody (150 Kd)     that binds to human CD11a (1) and is used for the treatment of plaque psoriasis. Efalizumab     was derived from the humanization of the murine efalizuman monoclonal antibody MHM24, which     recognizes human and chimpanzee CD11a. Humanization of MHM24 was accomplished by grafting the     murine complementarity determining regions (hypervariable region) into consensus human IgG1/     heavy and light chain sequences (Werther et al 1996). These same consensus human     immunoglobulin sequences have been successfully used in the humanization of other murine     antibodies, including those targeted to HER2 and IgE. Efalizumab inhibits the binding of     LFA-1 to intercellular adhesion molecule-1 (ICAM-1) thereby inhibiting the adhesion of     leukocytes to other cell types.      Ranibizumab is a recombinant, humanized, Fab fragment of a mouse monoclonal antibody targeted     against VEGF. As VEGF binds to cellular receptors, it stimulates angiogenesis and vascular     leakage. Blockade of VEGF by ranibizumab leads to reduced stimulation of cell proliferation     and permeability resulting in inhibition of angiogenesis and decreased leakage. Ranibizumab     intravitreal administration in neovascular AMD patients has been shown to effectively reduce     vascular leakage and growth of CNV and to stabilize or improve visual function.      To further improve visual acuity, a combination therapy using efalizumab and ranibizumab is     proposed. Efalizumab could target the adhesion factors that precede angiogenesis and improve     the outcome for AMD patients in combination with the anti-VEGF agent, Ranibizumab.   "
220171|NCT00726479|"     The primary objective of this study is to investigate the effect of 4-week treatment with 7.5     mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS and placebo on cough and sputum as     determined by the CASA-Q (Cough and Sputum Assessment Questionnaire   "
220172|NCT00726492|"     Osteoarthritis, a common disorder increasing in prevalence with advancing age, is     particularly debilitating when the knees are affected. This study examined the value of     hydrotherapy (exercise in water) and continuous short-wave diathermy (an electrical deep heat     treatment) for the relief of osteoarthritic symptoms.   "
220173|NCT00726505|"     The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss     in urine in healthy subjects and subjects with type 2 diabetes mellitus   "
220201|NCT00726882|"     The purpose of this follow-up study is to evaluate the frequency and persistence of specific     viral mutations in response to treatment with ABT-333 (dasabuvir).   "
220174|NCT00726531|"     The aim of the project is to evaluate the delivery, impact and cost effectiveness of a     community based exercise programme (FaME); compared to a home based exercise programme (OEP)     supported by similarly aged mentors; compared with usual care for primary care patients.      Primary Objective:        1. To determine the effect on continuation of exercise of two evidence based exercise          programmes designed for older people, compared with usual care i.e. with no special          interventions to promote physical activity.           Secondary Objective:        2. To determine the health benefits of the programmes to patients starting at various          levels of physical activity, particularly the effects on physical and psychological          status, health status and quality adjusted life years (QALYs).        3. To estimate the costs of the exercise interventions and to assess the cost-effectiveness          of community group exercise, and home-supported exercise compared with usual care.        4. To determine the acceptability of the programmes, adherence rates, enabling factors and          barriers to future implementation.        5. To determine participants' perceptions of the value of exercise, and the predictors of          continued exercise.   "
220303|NCT00735332|"     The objective of this study is to assess the efficacy and safety of TLN-232 used to treat     patients with metastatic melanoma that recur/progress after receiving first line systemic     therapy.   "
220176|NCT00726557|"     Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy     (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the     approved European labeling. The study will assess the tolerability, safety and efficacy of     the treatment with PegIntron plus Rebetol in this study population. The objective of the     study is to collect data on the prevalence of the hepatitis C infections in drug-substituted     patients. The study will also compare the feasibility of HCV (Hepatitis C Virus) treatment in     patients receiving Subutex® vs other drug substitution pharmacotherapies.   "
220177|NCT00726570|"     This study aims to assess possible alteration in coagulation (blood clotting) following     treatment with sequential compression devices (SCD) plus low-molecular weight heparin (LMWH)     as opposed to LMWH alone.      The investigators will examine coagulation in the early postoperative period of patients     undergoing major abdominal surgery during their stay in our Intensive Care Unit.      In addition to common laboratory tests, the investigators will examine coagulation using     TEG®, a device which allows a semi-quantitative examination of all phases of coagulation.   "
220178|NCT00726583|"     This study is being conducted to determine the safety and maximally tolerated dose of PX-866     when given orally on two different schedules: daily on days 1-5 and 8-12 of a 28 day cycle     and daily on days 1-28 of a 28 day cycle.   "
220179|NCT00726596|"     This phase II trial studies how well hydroxychloroquine works in treating patients with     previously treated prostate cancer. Autophagy destroys proteins and other substances in cells     and may be used by prostate cancer cells to survive. Hydroxychloroquine, which blocks     autophagy, may slow the growth of and possibly kill prostate cancer cells.   "
220180|NCT00726609|"     The purpose of this postmarketing surveillance study is to collect an extensive body of data     in a large patient population in every day life to investigate the safety and efficacy of     NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.   "
220181|NCT00726622|"     This study is being done to compare two types of surgery currently used for rectal cancer.     The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy     rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal     cancer in some medical centers, the effectiveness of this type of surgery compared to open     surgery is unknown. The study will compare the safety and effectiveness of the surgeries,     recovery from surgery in the hospital, overall recovery from surgery and cancer outcome.   "
220182|NCT00726635|"     The purpose of this study is to asses the impact of a tailored preoperative psychological     intervention on women with gynecological malignancies on psychological, physiological and     immunological parameters   "
220183|NCT00726648|"     Comparison of the effects of different CDP323 doses given over a period of four weeks on     blood biomarkers in subjects with relapsing forms of multiple sclerosis.   "
220184|NCT00726661|"     This is a multicenter, prospective observational cohort study (OCS) designed to follow     patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts     will be included:        -  Patients with human epidermal growth factor receptor 2-negative (HER2-negative) disease          receiving their first cytotoxic chemotherapy and/or targeted therapy (approximately 825          patients)        -  Patients with hormone receptor-positive (HR-positive) disease receiving their first          hormonal therapy for advanced disease (approximately 425 patients)      Patients who have received any chemotherapy for advanced disease more than 8 weeks prior to     enrollment to this OCS will not be eligible. A total of approximately 1,250 patients will be     enrolled. Approximately 150 study sites will be activated in order to achieve complete     enrollment by December 2010.   "
220185|NCT00726674|"     Treatment of diabetes mellitus type II with basal insulin, for patients treated in Clalit     outpatient clinics that are not adequately controlled with current treatment.   "
220186|NCT00726687|"     This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid     tumors.   "
220187|NCT00726700|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and     vincristine, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim,     may increase the number of immune cells found in bone marrow or peripheral blood and may help     the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such     as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them     or carry cancer-killing substances to them. Others interfere with the ability of cancer cells     to grow and spread. It is not yet known whether combination chemotherapy and pegfilgrastim is     more effective when given with or without rituximab in treating non-Hodgkin lymphoma.      PURPOSE: This phase II trial is studying the side effects of giving pegfilgrastim and     combination chemotherapy together with or without rituximab and to see how well it works in     treating older patients with aggressive B-cell non-Hodgkin lymphoma.   "
220188|NCT00726713|"     The purpose of this research study is to determine if Metanx improves sensory neuropathy in     persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a     physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which     are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be     randomly assigned to receive either Metanx or placebo for 6 months.   "
220189|NCT00726726|"     The purpose of this study is to determine whether BMS-708163 will effect the pharmacokinetics     of the commonly prescribed medicines midazolam, warfarin, caffeine,omeprazole and     dextromethorphan   "
220190|NCT00726739|"     RATIONALE: Aldesleukin may stimulate the white blood cells to kill tumor cells. Vaccines may     help the body build an effective immune response to kill tumor cells. Giving aldesleukin     together with vaccine therapy may kill more tumor cells. It is not yet known whether     aldesleukin is more effective with or without vaccine therapy in treating melanoma.      PURPOSE: This randomized phase II trial is studying how well aldesleukin works when given     with or without vaccine therapy in treating patients with stage IV melanoma.   "
220191|NCT00726752|"     This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses     and multiple doses   "
220192|NCT00726765|"     This is a multi-national, multi-site, observational study to determine which of two     strategies, when used by referring physicians is superior in the diagnosis of axial     spondyloarthritis (AS) by rheumatologists.   "
220193|NCT00726778|"     The main objective of this study is to investigate the effect of genetic and environmental     parameters on racial/ethnic differences in aspects of insulin secretion and action. The     genetic component will be modeled by estimating the degree of European genetic admixture     (ADM) obtained from approximately 50 ancestry informative markers (AIMs). The environmental     components will be modeled by measuring energy intake (food intake), energy expenditure     (physical activity) and socioeconomic status.   "
220194|NCT00726791|"     Chronic somatoform pain is common in psychiatric patients. Chronic somatoform pain causes     significant distress and disrupts social functioning. Moreover, chronic somatoform pain often     does not sufficiently respond to medication.      Chronic somatoform pain is associated with medial pain system. The medial pain system is     comprised of structures engaged in affect and motivation, such as medial thalamus and limbic     structures. The medial pain system gets inhibitory control from motor cortex. Functional     neuroimaging studies indicate that chronic somatoform pain is associated with hypoactivity of     motor cortex, defective inhibitory process, and hyperactivity of medial pain system.      Repetitive Transcranial Magnetic Stimulation (rTMS) is a safe and non-invasive tool to     modulate neurophysiologic activity of the focal brain. Therefore, pain relief by rTMS can be     obtained from motor cortex stimulation, restoration of defective inhibitory process, and     deactivation of medial pain system. Studies have shown that motor cortex stimulation using     rTMS can relieve pain in patients with neuropathic pain. However, to our knowledge, there is     no rTMS study on chronic somatoform pain in psychiatric patients. The purpose of this study     is to evaluate the effect of motor cortex rTMS on chronic somatoform pain.   "
220195|NCT00726804|"     Spondylarthropathy (SpA) comprises a group of rheumatic diseases mainly affecting the spine     and sacroiliac joints. In most of the patients disease activity alternates, and some patients     have symptom free periods. Tumor-Necrosis-Factor-alpha (TNF-alpha) antagonists have     significantly improved the treatment options for patients with spondyloarthritis. TNF-alpha     antagonist therapy is costly, implies an increased risk of infections, including reactivation     of tuberculosis, and the risk of long-term adverse events, as cancer, is fully clarified. It     is highly relevant to explore to which extent anti-TNF-alpha therapy can be discontinued in     SpA patients without immediate relapse of disease activity. Two studies have investigated     discontinuation of a TNF-alpha antagonist (infliximab and etanercept) in ankylosing     spondylitis, reporting flares in the majority of patients within the 1-year follow-up period,     with the longest times to relapse in patients with the lowest disease activity. The effect of     adalimumab discontinuation has never been studied, and, furthermore, the effect of     TNF-alpha-antagonist discontinuation has never been studied in patients with early     spondyloarthritis not fulfilling the New York criteria.   "
220196|NCT00726817|"     During this double blind, placebo controlled, randomised cross over study, healthy volunteers     received an enema once daily for one week containing either placebo (saline), 50mM butyrate     or 100mM of butyrate. Before and directly after each test period a barostat protocol was     performed to measure parameters for visceral perception.   "
220197|NCT00726830|"     RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is     not yet known whether methadone is more effective than morphine or oxycodone in treating pain     in patients with cancer.      PURPOSE: This randomized clinical trial is studying methadone to see how well it works     compared with morphine or oxycodone in treating pain in patients with cancer.   "
220198|NCT00726843|"     This study will examine the feasibility and acceptability of yoga for adolescents seen by a     medical practitioner for their headaches. The study will also examine whether yoga decreases     anxiety and improves quality of life. We hypothesize that yoga will be both acceptable and     feasible with a pediatric population. We also hypothesize that yoga will decrease anxiety and     improve quality of life.   "
220199|NCT00726856|"     This retrospective study evaluates the effectiveness and safety of ezetimibe plus statin or     ezetimibe plus fenofibrate in dyslipidemic patients that were treated with these dual     inhibition lipid lowering regimens as part of their normal standard of care. This study     assesses the percentage of patients who achieve LDL-C target goals and also evaluates the     patient compliance to treatment.   "
220200|NCT00726869|"     This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate     the combination of elotuzumab and bortezomib in subjects with MM following 1 to 3 prior     therapies. For the Phase 1 portion, elotuzumab will be administered by intravenous (IV)     infusion at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes     following the administration of bortezomib at 1.3 mg/m^2 IV bolus. Bortezomib will be given     in 21 day cycles (twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest     period). Elotuzumab will be administered as a separate infusion within 30 minutes following     bortezomib administration on the same days as the first and last dose of each bortezomib     cycle (i.e., Days 1 and 11).   "
220203|NCT00726908|"     High levels of the hormone insulin are associated with risk for heart disease and diabetes,     and may make it hard to lose weight. The types of food eaten may affect insulin levels. The     purpose of this study is to determine if manipulation of dietary carbohydrate content     improves insulin sensitivity (Si), augments weight loss, and promotes weight loss maintenance     in healthy adults.   "
220204|NCT00726921|"     This study investigates hypothesizes that the combination of dobutamine stress     echocardiography with dobutamine stress echocardiography with real time perfusion myocardial     contrast echocardiography and coronary computed tomography is a better modality for detecting     coronary artery disease in end-stage renal disease patients than coronary angiography, and in     predicting patient outcomes. Demonstrating this would lead to increased use of DSE with RTCE     and coronary CT at kidney transplant centers throughout the nation, leading to improved     anatomical and functional detection of CAD without the need for further invasive procedures.   "
220205|NCT00726934|"     The purpose of this study is to determine if FDA approved food safety guidelines are     equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of     infections during neutropenia in a sample of pediatric cancer patients.   "
220206|NCT00726947|"     The purpose of this study is to see if the investigators can use ultrasound imaging to     determine the type of clots in patients to help better manage their care.   "
220207|NCT00726960|"     The objective of this study is to determine whether aprepitant blocks the opiate reward     system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive     first line therapy for early heroin abuse.   "
220208|NCT00726973|"     The purposes of this study is to determine if combination reduced fluence photodynamic     therapy and Ranibizumab has:      Similar efficacy to Ranibizumab (Lucentis) alone. The ability to reduce the number of     intravitreal injection of Ranibizumab or a 13 month period The ability to reduce the number     of PDT treatments. The study will also collect information on the safety of combination     therapy and single therapy.   "
220209|NCT00726986|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving sorafenib together with     combination chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving sorafenib together with cisplatin     and etoposide works in treating patients with extensive-stage small cell lung cancer.   "
220210|NCT00726999|"     Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg     three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine     and placebo group with similar pills, also PCA morphine. The goal is to measure morphine     usage and incidence of morphine side effects (pruritis, days foley, days to first stool,     sedation, pain scores, PCA use).   "
220211|NCT00727012|"     This clinical study is a multicenter, prospective non-randomized observational study without     concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will     be included. The primary objective of the study is to demonstrate the effectiveness of the     SJM® Rigid Saddle Ring when used in mitral valve repair procedures.   "
220212|NCT00727025|"     Purpose: The aims of this randomized clinical trial are:        1. to assess scar quality from the patient and surgeon perspectives        2. to assess patient comfort in the days immediately following surgery        3. to assess the time taken to complete closure in the operating room.        4. the financial benefit or cost for the institution of using Steri Strip S will also be          estimated.      Two closure methods will be compared, a new coaptive film device (Steri Strip S) versus     standard subcuticular sutures. The linear incisions will include the standard incision     segments utilized for an inverted-T closure for bilateral breast reduction and the     transabdominal incision segments utilized for abdominoplasty or TRAM flap harvest.      Our hypothesis is that incisions segments closed with Steri Strip S compared to standard     subcuticular closure, will yield scars of better cosmetic quality, in shorter time to     closure, with novice and expert surgeons, for both bilateral breast reduction and     abdominoplasty surgical procedures.   "
220213|NCT00727038|"     Neovascular glaucoma is a potentially debilitating disease of the eye. Vascular eye disease     such as diabetes and vein occlusions can cause the retina to release factors that promote the     growth of abnormal blood vessels. These abnormal vessels can grow in the drainage mechanism     of the eye causing pressure in the eye to markedly increase. This can potentially cause     irreversible damage to the optic nerve from glaucoma leading to permanent blindness and     painful eyes. Conventional treatments including laser and freezing therapy take weeks to     cause regression in abnormal blood vessel growth. This delay often results in permanent     vision loss and pain. New medications targeted at more immediately reducing blood vessel     growth may aid in the treatment of this disease.   "
220214|NCT00727051|"     The overall goal of this study is to determine if non-invasive imaging with state of the art     CT coronary angiography can be used to screen for coronary artery disease in high risk     patients prior to liver and lung transplantation. The current protocol for coronary artery     disease assessment at UCSF before liver and lung transplantation involves screening with     stress tests and/or coronary angiograms in patients with increased risk of coronary artery     disease. Coronary angiogram will be used as gold standard for assessment of coronary CTA     accuracy.   "
220215|NCT00727064|"     The purpose of this study is to determine if the relative difference in Pharmacokinetics (PK)     between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with     desvenlafaxine SR and venlafaxine ER when a single dose is administered.   "
220216|NCT00727077|"     The objective of the study is to assess the safety and efficacy of Intron A (3 Mio I.E./m2, 3     times per week) and Rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common     medical practice at 10 sites in Germany. The primary objective is to determine if there are     any new severe adverse events observed with this recently approved dosing regimen. The study     will also evaluate the rates of eradication of the HCV virus.      This study was terminated due to low enrollment. At the time of termination, 3 participants     had enrolled. Therefore, these 3 participants transferred into study P04538 (NCT00727077) and     will be included in the P04538 (NCT00727077) data reporting.   "
220217|NCT00727090|"     Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia),     but there are few data in patients with neurologic disease. Very low serum sodium in patients     with brain injury can be life-threatening and is associated with cerebral edema (swelling of     brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or     stroke (cerebral infarction).      This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater     increase in sodium than usual care. Patients will be randomly assigned to usual care or the     lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other     interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics     and salt tablets. A blinded co-investigator will record neurologic examination results (NIH     Stroke Scale and Glasgow Coma Scale).   "
220218|NCT00727103|"     The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment     decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder.     Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g.     poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with     schizophrenia and comorbid nicotine and alcohol dependence.   "
220304|NCT00735345|"     The aim of this study is the evaluate the feasibility and safety of chemotherapy induction     treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in     the treatment of patients with non-metastatic esophageal cancer.   "
220305|NCT00735358|"     The recent practice guideline recommends endoscopic injection of cyanoacrylate (GVO) is the     preferred method to treat acute gastric variceal bleeding. The rebleeding rate remains high     following GVO.We hypothesized that a double-dose of cyanoacrylate may obliterate the varices     more effectively and achieve better hemostasis.   "
220219|NCT00727116|"     This project is designed to evaluate a statewide, hospital-based parent education program to     prevent abusive head trauma (AHT) in Pennsylvania, and investigate the additional     effectiveness and cost-effectiveness of booster sessions of parent education delivered to     parents at primary care provider offices in central Pennsylvania.      Specific Aims:        1. Assess the effectiveness of an established statewide program of hospital-based postnatal          parent education about violent infant shaking, provided at a single consistent point in          time between the infant's birth and hospital discharge, in reducing the incidence of          AHT.        2. Identify which component(s) are the most important mediators of the intervention's          effectiveness; determine whether the intervention effect is more directly related to          changes in perpetrator or caregiver behavior; and determine the effectiveness of the          intervention among various socioeconomic groups.        3. Determine the cost effectiveness of the hospital-based program.        4. Establish the feasibility, additional costs, and effectiveness of a combined program of          repeated exposure delivered both post-natally in the hospital and during follow up 2-,          4- and 6-month outpatient health maintenance visits with the pediatric care provider.   "
220220|NCT00727129|"     The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for     postmenopausal patients.   "
220221|NCT00727142|"     This study aims to provide class 1 evidence supporting or refuting the existence of normal     pressure hydrocephalus.   "
220222|NCT00727155|"     Medically ill patients with Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary     Disease (COPD) are at increased risk for developing symptoms of anxiety and depression and     are among the least frequent users of mental health services and treatments. To address the     needs of chronically ill patients, we created a time-limited psychosocial intervention to     maximize treatment benefits and improve the efficiency and ability of mental health care     practitioners to provide services within medical care settings. This study is separated into     two randomized study groups. The first group of participants will receive the ACCESS     intervention immediately. The second group of participants will be followed for a period of 6     months. After a period of 6 months, those who continue to have symptoms of depression and/or     anxiety will be offered the ACCESS intervention.   "
220223|NCT00727168|"     The purpose of this study is to study the prevalence of glaucoma in Korea, the investigators     selected Namil area in Geumsan city, located in central Korea. The residents aged over 40 in     this area are to be recruited to full ophthalmologic examination to detect and classify the     glaucoma.   "
220224|NCT00727181|"     This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve     by establishing associated adverse event rates, clinical status as indicated by New York     Heart Association (NYHA) functional classification, hemodynamic performance, and hematology     analysis.   "
220225|NCT00727194|"     The purpose of this study is to determine whether eculizumab is safe and effective in the     treatment of patients with generalized myasthenia gravis despite treatment with various     immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and     cyclophosphamide, that are currently available.   "
220226|NCT00727207|"     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well everolimus works in treating older patients     with mantle cell lymphoma who received previous first-line or second-line chemotherapy.   "
220227|NCT00727220|"     The purpose of the study is to examine glycemic and neuropsychological outcomes in very young     children with Type I diabetes who are being started on insulin pumps and to compare their     outcomes to children who are not utilizing insulin pumps. We propose to assess 40 children     with IDDM under 5 years of age. 10 patients examined will be using multiple daily injections     with basal glargine, 10 will be using NPH or Lente and rapid-acting insulin, and 20 will be     examined prior to and 12 months after the implementation of insulin pump therapy. These     subjects will be recruited and followed because they are currently undergoing treatment for     Type 1 diabetes. Children will be recruited based upon the insulin regimen that they and     their primary diabetes physician have chosen to utilize clinically. Insulin regimens will not     be changed by the study team. Outcome measures will examine: glycemic outcomes (overall     control, blood sugar variability), cognitive outcomes, parenting Stress, and changes in diet.   "
220238|NCT00734123|"     The incidence of cardiovascular diseases is still high and further efforts should be done in     primary prevention. The main objective is to quantify the burden of subclinical     atherosclerosis using non-invasive techniques,and to study the impact of this assessment and     consequent treatment in the progression of atherosclerosis and in the incidence of     cardiovascular diseases.   "
220239|NCT00734136|"     This Study will look at the effect of substances called angiogenic factors(development of     new blood vessels) have on the development of severe liver disease. The results may help to     understand the factors involved in the repair and regeneration of liver tissue and to see if     different types of liver disease are associated with different types of factors, especially     in the severe liver disease called hepatorenal syndrome.   "
220228|NCT00727233|"     Background:      Patients with neurofibromatosis type 1 are at increased risk of developing tumors called     plexiform neurofibromas (PN) that arise from nerves. These tumors are usually non-cancerous,     but they can cause serious medical problems.      Sorafenib was recently approved to treat patients with kidney cancer and is now being tested     in children with cancer. It affects several pathways thought to be important for the     development and growth of PN and may therefore shrink these tumors or slow their growth.      Objectives:      To determine the highest dose of sorafenib that can safely be given to children and young     adults with PN.      To identify the side effects of sorafenib in these patients.      To study how the body handles sorafenib by measuring the amount of drug in the bloodstream     over time      To determine how the drug affects blood flow and blood cells and proteins.      To determine if sorafenib can shrink or slow the growth of PN.      To determine the effects of sorafenib on learning, attention, memory, and quality of life.      Eligibility:      Patients between 3 and 18 years of age with NF1 who have inoperable PN that can cause     significant disability.      Design:      Patients take sorafenib tablets twice a day in 28-day treatment cycles. They may continue     treatment until their tumor grows or they develop unacceptable drug side effects. In this     dose escalation study, the dosage is increased with every 3 to 6 children who are enrolled     until the highest safe dose is determined. In any case, the dose will not exceed that used in     children with cancer.      Patients are monitored regularly with physical examinations, blood and urine tests, MRI scans     and quality-of-life questionnaires.      Patients whose bones are still growing have periodic x-rays of the hips and lower legs to     monitor for possible changes in the structure of growing bones.      Patients have periodic tests of learning and memory before starting treatment and before     cycles 4, 12, 18 and 24.      Patients have pharmacokinetic studies to examine how the body handles sorafenib. blood     samples are drawn before the first dose of sorafenib and then at 30 minutes, 1 hour, 2 hours,     3 hours, 5 hours, 8 hours, 10 to 12 hours, 24 hours and 30 to 36 hours following the first     dose.   "
225429|NCT00790985|"     To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of     the knee.   "
220229|NCT00727246|"     The purpose of this study is to determine whether an investigational drug, called     CDP-Choline, improves memory in people with traumatic brain injury (TBI). To do this, we     are asking for people with traumatic brain injury and people without traumatic brain injury     to be a part of this study. We will compare results between each group to see if this     investigational drug makes a difference with memory. We will also compare brain imaging     results and information collected before and after the taking of the study medication to see     if there are any differences. We hypothesize that there will be differences in brain     activation patterns between individuals with TBI and healthy controls, as well as differences     in performance on memory testing at baseline. We further hypothesize that, after treatment     with CDP-Choline, the patterns in neuroimaging findings and cognitive testing results for     individuals with TBI will more closely resemble results observed for healthy individuals. We     hope that what we learn from this study will be helpful in the future treatment of     individuals with head injury.   "
220230|NCT00727259|"     The current gold standard for treatment of chronic hepatitis C (CHC) patients is with     pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will     definitely determine treatment effectiveness. This is the idea behind the development and     usage of the PegPen. The goal of this study is to determine the satisfaction grade with this     novel device.   "
220231|NCT00727272|"     The purpose of this study is to evaluate and compare the relative bioavailability of Quinine     Sulfate 324 mg capsules, manufactured by the Mutual Pharmaceutical Company, to Quinine     Sulphate 300 mg tablets, manufactured by the Government Pharmaceutical Organization, Bangkok     Metropolis, Thailand, after single oral dose administration under fasting conditions. An     additional purpose of this study is to evaluate the effect of food on the Mutual     Pharmaceutical Company product.   "
220232|NCT00727285|"     Presently, effectiveness of treatments for CF lung disease is judged by improvement in lung     function (FEV1). However, in CF patients, FEV1 can range from severely decreased to normal,     and improvements may occur slowly. Thus, clinical trials require many patients over prolonged     periods to evaluate medications. As the pace of drug development accelerates, it is no longer     possible to test all of the promising candidate therapies using conventional study designs. A     sensitive technique for assessing lung inflammation has been developed which uses the     expression of genes located in circulating blood cells. Mononuclear cells pass repeatedly     through the blood vessels of the lung, and are exposed to many of the inflammatory products     that are present in the airways. Over the past 4 years the investigators have identified a     small group of candidate genes that are unregulated or downregulated in response to     antibiotic treatment. The investigators now propose to prospectively test this method of     quantifying lung inflammation in a large group of CF patients undergoing treatment of     pulmonary exacerbations. Blood will be sampled before and after antibiotic treatment for a     pulmonary exacerbation, and the relative change in gene expression will be compared to     improvement in FEV1 and other clinical responses, to determine the utility of this method for     use in studies. If successful, this technique could allow for a rapid and noninvasive method     to gauge immediate effects by new treatments, and assist caregivers in determining optimal     treatment strategies for the individual.   "
220233|NCT00727298|"     This study will be performed to evaluate and document the safety and efficacy of infliximab     (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily     routine practice of rheumatologists, gastroenterologists, and dermatologists.   "
220234|NCT00727311|"     The objective of the study is to assess the safety and efficacy of PegIntron injector and     Rebetol administered to participants with chronic hepatitis C. Participants will be treated     by general practitioners in clinical practice as part of the post-marketing surveillance     study. The study will assess the rates of eradication of the hepatits C virus and the rates     of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200     mg/day) in common medical practice in Germany.   "
220235|NCT00734084|"     The primary purpose of this investigation is to evaluate the surgical performance of the     DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a     Multi-centre setting.      The secondary objective of this investigation is to evaluate the long-term survivorship of     the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.   "
220236|NCT00734097|"     The purpose of this study is to assess how patients with gastro-oesophageal reflux disease     (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still     experiencing symptoms will benefit from a change in treatment.   "
220237|NCT00734110|"     The main purpose of this study is to record information from clinical and radiographic     examinations and patient assessment questionnaires before surgery and at suitable     postoperative intervals to assess the functioning and symptomology of each knee following     surgery.      In addition, any adverse events or complications are to be recorded, and any device failures     or early revisions are to be recorded and reported directly to the Sponsor. The data are to     be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum     of 5 years.   "
221496|NCT00743938|"     The purpose of this study is to improve disease control and survival for patients who were     treated with chemotherapy using BMS-690514 over erlotinib   "
220240|NCT00734149|"     The purpose of this study is to assess the efficacy of bortezomib in combination with     melphalan and prednisone to achieve complete responses for patients with previously untreated     multiple myeloma compared to an historical control group. This trial will also evaluate the     safety and toxicity of this regimen as well as evaluate the duration of response of this     regimen.   "
220250|NCT00734279|"     The purpose of this study is to determine if the timing of the onset of puberty may be     affected by FSH-regulatory peptides.      We will determine how these peptides relate to FSH production in prepubertal and pubertal     children by comparing the regulation of FSH control in children with precocious (early)     puberty and delayed puberty.      In this pilot study, we will stimulate the pubertal axis using an agonist of GnRH to     determine the pubertal response of activin-A, inhibin-A and -B and follistatin.      To determine baseline FSH secretion and FSH-regulatory peptide tone, we will block GnRH with     a specific antagonist.      These studies should lead to a better understanding of the role of FSH in controlling the     onset of puberty and the pathogenesis of pubertal disorders.   "
220251|NCT00734292|"     The primary purpose of this study is to evaluate the early bronchodilating effect of SKP     FlutiForm HFA pMDI compared to placebo.   "
220241|NCT00734162|"     The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability     of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic     hepatitis B virus (HBV) infection.      The optimal treatment for adolescents with chronic HBV infection is currently unknown.     Treatment with interferon alfa, lamivudine, and adefovir dipivoxil in pediatric populations     has been shown to be less than optimal. Further, the safety and efficacy of entecavir and     telbivudine have not been established in patients < 16 years of age. A study evaluating TDF     in adolescents (ages 12-17) was needed to assess the safety and efficacy of this agent in the     treatment of chronic hepatitis B in this patient population. In addition, the study will help     to further elucidate the pharmacokinetic (PK) and resistance profiles of TDF. Through their     participation, study participants will help generate critical new information to help guide     the most optimal treatment of chronic HBV infection in adolescents.      This is a randomized, double-blind study to evaluate the antiviral efficacy, safety, and     tolerability of TDF versus placebo in adolescents with chronic HBV infection. TDF     treatment-naive participants were randomized in a 1:1 ratio to TDF or placebo. After 72 weeks     of blinded treatment, participants were to switch to open-label TDF for an additional 2.5     years of treatment, provided that no safety concerns are identified by the Independent Data     Monitoring Committee monitoring the study.   "
220242|NCT00734175|"     In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were     associated with significant morbidity and mortality. It is estimated that, in the United     States alone, the next influenza pandemic could cause approximately 200,000 deaths and     750,000 hospitalizations. Thus, the development of a vaccine against potential influenza     strains has become a priority. The purpose of this study is to determine the safety and     immune response to an H6N1 influenza vaccine candidate.   "
220243|NCT00734188|"     This is an open-label, dose-escalation study to determine the safety, maximum tolerated dose     (MTD) and dose-limiting toxicities (DLT) of 188Re-PTI-6D2 in patients with metastatic     melanoma.   "
220244|NCT00734201|"     Randomised, double-blind, parallel group comparison of four dose levels of V24343 and placebo     to study the effect of V24343 on blood pressure and weight in obese subjects.      The primary variables, change in blood pressure (BP) and pulse, will be assessed both by     outpatient ambulatory monitoring of vital signs and by regular clinic monitoring.      The efficacy of V24343 will be assessed by measurement of body weight, waist circumference,     bioimpedance assessment of body composition and blood glucose.      Assay of plasma concentration of V24343 in blood samples collected at intervals after dosing     will be used to assess the pharmacokinetics of V24343.      Other safety assessments comprise routine monitoring of adverse events; concomitant     medication; clinical laboratory safety tests, 12-lead electrocardiograms (ECG) and     self-completed psychiatric assessments.   "
220245|NCT00734214|"     Children who are undergoing surgery need intravenous fluids to prevent dehydration and     maintain their electrolyte balance. The current standard of care in these children is to use     a fluid which is low in sodium (hypotonic fluid). The safety of this practice has never been     tested. There is ongoing concern from the medical community that this type of fluid increases     the child's risk of developing low sodium levels, and hence may not be safe for all children.     Low sodium can lead to significant complications such as seizures, coma and even death, risks     of which are often underestimated and not anticipated by their caregivers. Experts in the     field suggest that giving a solution with a similar sodium content to that of blood (isotonic     fluid) reduces the risk of these problems in these children. This study will compare these     two types of intravenous fluids (hypotonic versus isotonic), in a blinded fashion (i.e.     neither the patient nor caregivers or investigators will be aware which type of fluid the     patient is receiving), in children following surgery. The investigators goal is to see which     type of fluid is safer, and leads to more stable sodium levels. This would in turn lead to a     lower risk of complications as described above.      This is the first time such a study is preformed in pediatrics. There are unnecessary number     of complications and potential deaths from this disorder, and hence the safety of everyday     fluid practice in children needs to be scientifically tested. The results of this study will     enable the investigators to propose scientifically based guidelines on how to minimize risks     associated with intravenous infusions in children.   "
220246|NCT00734227|"     In unselected cirrhotic patients with acute portal hypertension-related bleeding to compare     the effectiveness in control of bleeding, mortality rate, duration of life, quality of life,     and economic costs of two widely used treatment measures: (1) emergency transjugular     intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.   "
220247|NCT00734240|"     The purpose of this study is to evaluate the safety and tolerability of single and multiple     doses of ISIS 353512, to evaluate the blood concentration and rate elimination of ISIS 353512     from the blood, and to evaluate the effectiveness of ISIS 353512 in lowering a protein in the     blood associated with inflammation.   "
220248|NCT00734253|"     The primary objective of this study is to evaluate the efficacy of two different doses of     Pyridorin (150 mg and 300 mg)compared to placebo in retarding the progression of diabetic     nephropathy. This will be assessed by measuring the change in serum creatinine and other     biomarkers of kidney disease during the course of the 1-year study.   "
220249|NCT00734266|"     The hypotheses of this study are that:        -  Production and release of inflammatory substances called leukotrienes are increased          during heart surgery with use of a heart-lung machine in humans;        -  The increase in these leukotrienes levels after heart surgery is higher in patients with          bronchitis and/or emphysema than in patients without previous history of lung disease;        -  Levels of leukotrienes are directly correlated with worsening of lung function during          and after heart surgery.   "
220273|NCT00734929|"     We hypothesize that the combination of aprepitant with dexamethasone will provide     significantly improved prophylaxis against Postoperative nausea and vomiting compared with     the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under     general anesthesia.   "
220252|NCT00734305|"     This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 3+3     design to determine maximum tolerated dose/recommended Phase 2 dose.   "
220253|NCT00734318|"     The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the     treatment of severe persisent asthma in adult subjects.   "
220254|NCT00734331|"     There is a reciprocal relationship between the central nervous system and the immune system.     Stimulation of the vagus nerve results in secretion of acetylcholine (Ach) which decreases     secretion of pro-inflammatory cytokines. Acetylcholine esterase is an enzyme that neutralizes     Ach and thus, involves in regulation of Ach levels, and in the cholinergic tone and     inflammatory state.      MicroRNAs (miRs) are evolutionarily conserved, RNAs that regulate gene expression. The     investigators hypothesized that miRs controlling systemic communication processes function in     one tissue in response to signals (i.e. neuronal, hormonal or others) from another.      Specifically, the investigators hypothesized that miRs control the inflammatory response in     inflammatory bowel diseases through regulation of expression of messenger RNA of AchE.   "
220255|NCT00734344|"     This is a single-site, investigator-initiated, open-label, randomized/controlled clinical     trial to compare the viral load response in plasma (and, in a subset of subjects, in     gastrointestinal lymphoid tissue reservoirs) in subjects with acute/early HIV-1 infection     treated with 12 weeks of raltegravir-based versus efavirenz-based ART (each combined with     tenofovir/emtricitabine). Subjects will receive a self-limited course of therapy rather than     a commitment to life-long HAART, as has been the experimental approach in a variety of     clinical protocols in the United States and Europe. Subjects will complete a 12 week course     of therapy, and those who meet treatment-response and safety criteria will then undergo a     similarly intensive period of virology and immunology monitoring to compare the timing and     dynamics of any observed virologic rebound following the treatment intervention.   "
220256|NCT00734357|"     The purpose of this study is to determine if one CT contrast agent (medication injected into     a vein; used in CT examinations to help produce clearer images) is safer to use than another.     This study will compare the safety of two widely-used, U.S. FDA approved contrast agents,     Isovue and Omnipaque. The investigators hypothesize that there is no significant difference     in the rates of contrast-induced nephrotoxicity (CIN) between these agents when the overall     population consists of low-risk patients.   "
220257|NCT00734370|"     Virtual Reality Exposure Therapy (VRET) is an effective treatment for anxiety disorders,     particularly for specific phobias as fear of heights and fear of flying (e.g. Powers &     Emmelkamp, 2008). Recent technological advances (e.g. more realistic avatars) make research     into the efficacy of VRET for participants with elevated agoraphobic symptoms desirable.     Therefore, the aim of the present research proposal is to investigate the comparative     efficacy of:        1. enhanced VRET making use of the latest avatar technology with        2. exposure in vivo in agoraphobic participants        3. wait-list control.   "
220258|NCT00734383|"     The purpose of this study is to determine if an intravenous anesthetic with antioxidant     properties will protect the heart of diabetic patients from injury while undergoing coronary     bypass surgery.   "
220259|NCT00734396|"     The purpose of the study is to test the safety and feasibility of autologous mesenchymal stem     cell therapy in HLA-DR mismatched patients with subclinical rejection and or an increase in     IF?TA in the renal biopsy 4 weeks or 6 months after renal transplantation.   "
220260|NCT00734409|"     The purpose of this study is to determine if the use of a device called the BIS monitor in     addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's     level of sedation.   "
220261|NCT00734773|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as rituximab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Radiation therapy uses high-energy x-rays to kill cancer     cells. Motexafin gadolinium may make cancer cells more sensitive to radiation therapy and     combination chemotherapy. Giving motexafin gadolinium together with chemotherapy, rituximab,     and radiation therapy may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects of giving motexafin gadolinium     together with combination chemotherapy, rituximab, and whole-brain radiation therapy and to     see how well it works in treating patients with newly diagnosed primary central nervous     system lymphoma.   "
220262|NCT00734786|"     The main objective of the trial is to determine whether the current topical formulation of     GTX 2/3 reduces the wrinkling of the skin (crow's feet) after a single application      Other evaluation criteria include: safety assessment and local tolerance, depth of facial     wrinkles (video microscopy imaging).   "
220274|NCT00734942|"     The purpose of this study is to develop and implement evidence-based and family-oriented     support for young carers and their families in Germany. Hypothesis is that families' own     support mechanisms, combined with externally provided support that is determined by the     families' specific needs, will help to overcome their burden and enable families to live in     the way they wish to despite chronic illness. This will lead to a measurable increase in     HRQOL of children concerned.   "
220354|NCT00736008|"     The study will assess the clinical and laboratory data of about 100 pediatric patients     diagnosed and treated at the Pediatric Hematology Unit during the years 1980 until 2007     because of thrombotic events.      The results, the treatment given, and the outcome of the patients will be summarized.   "
220263|NCT00734799|"     A substantial number of US Veterans are suffering from Posttraumatic Stress Disorder (PTSD)     following deployment in recent military conflicts, and sleep disturbance is a primary     complaint of Veterans presenting to the VA with PTSD. Veterans with PTSD have more     self-reported and physician-rated health problems, and health status is associated with PTSD     symptom severity. Most Veterans meeting criteria for PTSD report difficulty initiating or     maintaining sleep (70-91%), and increased PTSD severity is associated with increased sleep     disturbance. Even after receiving treatment for PTSD, Veterans continue to experience     residual insomnia at a rate of about 50%, in spite of having achieved PTSD remission.      There are currently no PTSD-specific sleep interventions available, excepting an intervention     that is specific to nightmares. Given the prevalence of sleep disturbance in Veterans with     PTSD, the absence of interventions for PTSD-related sleep problems, and the increasing number     of post-deployment Veterans with trauma-related sleep difficulties, such interventions are     desperately needed. In this study, we will test the effectiveness of a multi-component     cognitive-behavioral sleep intervention for PTSD that targets both nightmares and insomnia     for improving the overall sleep experience of Operation Iraqi Freedom (OIF) and Operation     Enduring Freedom (OEF) Veterans with PTSD who are also receiving usual care. The primary     objective is to pilot test the intervention for efficacy in reducing sleep disturbance. The     secondary objective is to examine the relative impact of the intervention on PTSD symptoms.     The project is a prospective, randomized, clinical intervention trial. Participants will be     randomly assigned to a multi-component cognitive-behavioral sleep intervention for PTSD +     Usual Care, or Usual Care alone. We are hypothesizing that 1) Veterans receiving the sleep     intervention plus usual care will produce greater improvements (reduced total wake time,     increased sleep efficiency, etc) in subjective sleep measures than will Usual Care alone; 2)     Veterans receiving the sleep intervention plus usual care will produce greater improvements     in nightmare frequency and severity than will Usual Care alone; and 3) the relationship     between PTSD symptoms and treatment group will be significantly related to sleep quality in     the period intervening baseline and follow-up.   "
220264|NCT00734812|"     The purpose of this research study is to evaluate whether there is any difference in recovery     time and return to normal activities following a laparoscopic supracervical hysterectomy     (LSH) compared with total laparoscopic hysterectomy (TLH). Both types of hysterectomies are     commonly performed at our institution.      Patients will be assigned by chance (like a coin toss) to have either a LSH or a TLH.     Preoperatively, participants will complete a quality of life questionnaire (SF-36), a sexual     function questionnaire (FSFI)and a 3 question questionnaire about urinary function (3IQ).      Following surgery participants will be asked to keep a diary of pain symptoms and use of     narcotics. The diary will be filled out daily until patients have resumed normal activities     from prior to the surgery. The SF-36 will be completed again 6 weeks following the original     surgery.      6 months following surgery participants will receive a copy of the SF-36 and the FSFI in the     mail. They will also be asked questions about urinary symptoms and persistent vaginal     bleeding.   "
220265|NCT00734825|"     The purpose of this study is to compare IV contrast only vs. IV and oral contrast Computed     Tomography (CT) for the diagnosis of acute appendicitis in adult patients in our emergency     department. A secondary purpose will be to design a specific CT for appendicitis protocol at     our institution at the conclusion of this study.   "
220266|NCT00734838|"     The objective of the proposed research is to develop new diagnostic modalities based on     optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of     breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery     part of the study, all patients scheduled to have a mastectomy or lumpectomy for the     treatment of breast cancer will be asked if they would be willing to participate in this     study. For the core needle biopsy part of the study, patients with a higher pre-probability     of cancer (based on mammography) will be recruited to increase the number of patients with     malignant lesions and enrolled in this investigation.   "
220267|NCT00734851|"     This is a single arm phase II study of docetaxel, prednisone, and sunitinib systemic therapy     followed by salvage external beam radiation therapy for men who have experienced PSA     recurrence following initial radical prostatectomy for prostate cancer. The primary aim is     the rate of progression-free survival at 2 years as measured by lack of PSA progression and     no evidence of disease. We hypothesize that this aggressive initial systemic therapy will     improve the long term remission rates for men who are undergoing salvage radiation therapy     for PSA recurrence in the absence of metastatic disease.   "
220268|NCT00734864|"     The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose     limiting toxicity (DLT) of dasatinib when combined with protracted, daily temozolomide (TMZ).     Secondary objectives are: To further evaluate the safety and tolerability of dasatinib plus     protracted, daily TMZ; 2. To evaluate the pharmacokinetics of dasatinib when administered     with protracted, daily TMZ among recurrent malignant glioma patients who are on and not on     CYP-3A enzyme inducing anti-epileptic drugs (EIAEDs); 3. To evaluate for anti-tumor activity     with this regimen in this patient population.   "
220269|NCT00734877|"     Toward improving the therapeutic index of standard TT3 (S-TT3), the investigators will employ     a randomized Phase III trial design to determine whether S-TT3 treatment-related toxicities     can be reduced by 50% in TT3-Lite (L-TT3).      Note: Randomization has been discontinued and accrual is closed to the L-TT3 arm. This trial     is currently enrolling as a single-arm trial for patients to receive S-TT3.   "
220270|NCT00734890|"     RATIONALE: Vandetanib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab and     vandetanib may also stop the growth of cancer cells by blocking blood flow to the cancer.     Giving vandetanib together with bevacizumab may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and     bevacizumab in treating patients with advanced solid tumors or lymphoma.   "
220271|NCT00734903|"     The purpose of this study is to examine in Veterans the efficacy of an evidence-based     gender-specific treatment model for women with substance use disorder (SUD).   "
220272|NCT00734916|"     Immune modulating properties of parenteral lipid emulsions seem to contribute to the     increased risk for infections which remains associated with the use of total parenteral     nutrition. Emulsions based on soy bean oil (SO) are the oldest and still most widely used     lipid source in TPN formulations but their high content of omega-6 polyunsaturated fatty     acids (PUFAs) may be a drawback. Fish oil-based lipid emulsions (FO), rich in omega-3 PUFAs,     has been approved for parenteral nutrition in many countries. Mainly retrospective studies on     clinical outcomes in septic and postoperative patients have suggested clinical benefits with     the inclusion of FO in parenteral nutrition regimens. The exact mechanisms behind the     beneficial immunological effects of parenteral FO have, however, not yet been elucidated.      Objective:      To evaluate the effects of intravenous infusion of a FO-based lipid emulsion and a SO-based     emulsion on immune function as evidenced by effects on peripheral blood leukocyte counts and     functions and on the susceptibility to oxidative stress.      Study design:      Randomized placebo controlled cross-over pilot study with healthy volunteers.   "
220275|NCT00734955|"     Our objective is to develop a novel optical assay system for intra operative assessment of     tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown     that optical techniques can effectively discriminate between malignant and non-malignant     breast tissues. We have also shown that data collection and processing from a single point on     the tissue specimen requires less than 5 seconds. In addition, the technique is easily     adaptable to provide sensing depths that are required for breast margin assessment. The goal     of the work proposed in this protocol is to test the sensitivity and specificity of an     optical assay system developed by our group, for intra operative assessment of breast tumor     margins.   "
220276|NCT00734968|"     This project will determine whether post-operative prophylaxis with macrobid will decrease     the incidence of postoperative urinary tract infection in women receiving sub-urethral slings     for the treatment of urinary incontinence.   "
220277|NCT00734981|"     Evaluation of specificity and sensitivity of Seaforia- an vitro diagnostic system for     evaluating semen quality.   "
220306|NCT00735371|"     The study will evaluate the efficacy of LDX treatment group compared to placebo on the change     from Baseline ADHD-RS-IV score at endpoint.   "
220283|NCT00735059|"     A current trend in dialysis membrane engineering is to maximize the permeability for larger     low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do     not meet these requirements. Particularly in convective procedures, such as     hemodiafiltration, their albumin leakage is too high [10]. POLYNEPHRON™, the membrane which     is built in to the new Nipro ELISIO® dialyzer, is a new dialysis membrane, produced by     applying an innovative spinning technique. The incentive of its development was to improve     the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile     for low-molecular weight proteins without significant loss of essential larger proteins at     best biocompatibility properties, for a more adequate dialysis therapy. Purpose of the     planned study is to demonstrate the superior performance at lower albumin loss in different     dialysis procedures of the new Nipro ELISIO® dialyzer compared with a control dialyzer with     regard to the removal of the whole range of uremic toxins.   "
220284|NCT00735072|"     Many people with HIV fail to regain normal CD4 counts despite effectively suppressing HIV     replication with medications. Blocking the co-receptor for HIV might decrease inflammation     of the immune system, potentially providing an immune benefit. The goal of the current trial     is to determine whether adding maraviroc, a new CCR5 co-receptor blocker, decreases     inflammation, providing an immune benefit for patients with low CD4 counts despite     undetectable viral loads on HIV medications.      In this study, HIV-infected patients who are receiving antiretroviral therapy for HIV will     receive either maraviroc or a placebo (sugar pill) each day for 24 weeks. After 24 weeks, the     study medication will be stopped and all subjects will be followed for 12 more weeks. Blood     tests measuring the extent of inflammation, low-level viremia, and immune function will be     measured throughout the trial and compared between treatment arms.   "
220285|NCT00735085|"     A Randomized, Double Blind, Placebo Controlled, Phase 2 Dose Escalation Study to Investigate     the Safety and Pharmacokinetics after Single and Multiple I.V. Doses of SLV334 in Sequential     Cohorts of Patients with Moderate and Severe Traumatic Brain Injury.   "
220286|NCT00735098|"     Knee Osteoarthritis (OA) is one of the most frequent causes of physical disability and pain     among adults. Recent evidence suggests that shorter exercise programs that incorporate     kinesthesia, balance and agility (KBA) techniques may result in more rapid symptom relief and     functional improvements in comparison to traditional therapeutic exercise. KBA techniques are     designed to improve dynamic joint stability by using a series of activities which challenge     balance and coordination. To determine the independent effects of KBA training on functional     abilities, it is necessary to test it as a training program unto itself. The proposed     clinical trial is designed to do this by using three training groups: KBA only; lower     extremity strength training only; and a combination of the two. The total exercise time and     intensity of each condition will be approximately equal. A non-exercise group will control     for any effects related to the testing procedures and the passage of time. Community     volunteer men and women age 50 and over with physician diagnosed symptomatic knee OA will     participate.   "
220287|NCT00735111|"     The purpose of this study is to determine if patients are able to self-rate their physical     abilities and how these ratings compare to the ratings of their health-care provider.   "
220288|NCT00735124|"     The study will investigate the effects of single dose pre-operative oral dose of gabapentin     (1200) on post -operative pain scores and oral analgesic requirements.   "
220289|NCT00735137|"     The aim of the study is to determine the effect of cerclage pessary on the incidence of     spontaneous delivery between randomization (at 20-24+6 weeks) and 33+6 weeks in asymptomatic     women with singleton pregnancies found at routine mid-trimester screening to have a cervix of     <25 mm in length and in twin pregnancies.   "
220290|NCT00735150|"     We are inviting you to participate in a study of how people who have had genetic counseling     for breast/ovarian cancer risk feel about certain reproductive technologies, preimplantation     genetic diagnosis (PGD) and prenatal genetic diagnosis (PND), that may reduce the chances of     passing increased risk onto one's children. We would also like feedback from patients who     have been to our clinic in the past on the best ways to talk about PGD and PND during genetic     counseling sessions. We are seeking both the opinions of people who are interested in these     technologies and those who are not. It does not matter whether you have heard of PGD or PND     before - you can still participate. Your past experience with genetic counseling is valuable     to us in deciding how to communicate this information during sessions.   "
220291|NCT00735163|"     Hyperglycemia is common in critically ill patients and associated with an adverse outcome.     Recently, large randomized controlled trials have demonstrated that tight glycaemic control     (TGC) reduces morbidity and mortality in this population. Based on this emerging evidence     intensive insulin therapy is currently finding its way into the critical care practice.      In the meantime numerous insulin infusion protocols, which are based on frequent bedside     glucose monitoring, have been implemented. Recent reviews comparing different types of     protocols describe widely ranging practice and difficulties in achieving TGC despite     extensive efforts of the intensive care unit (ICU) staff. A fully automated algorithm may     help to overcome some of these limitations by excluding intuitive interventions and     integrating relevant clinical data in the decision-making process. The primary objective of     the current study is to investigate the performance (efficacy) of a control algorithm for     glycaemic control in ICU patients for the whole length of ICU stay.   "
220292|NCT00735176|"     The study will compare cervical arthroplasty with cervical discectomy and fusion, in the     treatment of cervical radiculopathy. The 0-hypothesis is that there is no difference between     the two methods, when comparing primary and secondary outcome variables.   "
220307|NCT00735384|"     The primary aim of the project is to apply the non-invasive stimulated muscle force     assessment system to i) intensive care unit patients and ii) patients with primary myopathy     or subclinic myopathy (e.g., Duchenne muscular dystrophy, Myotonia, MH). The investigators     will use this new methodology of force assessment to phenotype patients weakness during their     illnesses (depict typical force pattern) and monitor recovery periods, or disease     progression, respectively. This new system will be evaluated until the year 2018. The     investigators will determine variables of isometric skeletal muscle force.      These systems should serve as force monitoring tools and help to guide therapies.   "
220682|NCT00741897|"     To determine the safety and efficacy of Fexofenadine (Telfast®) 30mg pediatric tablets on     Filipino children aged 6 to 11 for the relief of symptoms associated with perennial and     intermittent allergic rhinitis.   "
220293|NCT00735189|"     Warfarin is a medication typically referred to as a blood thinner and is used to prevent the     formation of blood clots, and hence prevent life-threatening events such as strokes and clots     on the lungs (known as pulmonary emboli). This therapy is only safe and effective if the     degree of blood thinning is kept within a narrow window - if the blood is too thick clots     may form but if the blood is too thin the risk of bleeding increases. Complicating the     control of warfarin is that different people require different amounts of it to have an     appropriate degree of blood thinning, and once this amount is determined for a patient, it     may be changed by factors that are encountered on a daily basis (i.e., diet, acute and     chronic diseases, alcohol, medications, etc.). As such, regular monitoring is necessary to     confer the benefits of this medication. Our Anticoagulation Management Service (AMS) has     demonstrated really good control of blood thinning therapy by working with patients to inform     them of the rationale for this medicine, the factors having the ability to impact its     control, and encouraging the patient to be involved in their care (via provision of tools to     document test results, one-on-one education and access to our program at any time with     questions, etc.) Currently, our AMS has to limit the volume of patients seen due to resource     limitations. As such, it is imperative that we investigate alternate strategies to manage     these patients. Paramount, however, is that any long-term strategy must not confer inferior     control of warfarin. The purpose of this study is to determine if the impact of AMS Care is     sustained following the transfer of anticoagulation management to the family doctor.     Operationally, the results of this study will guide future management of patients. If control     of warfarin therapy declines with family doctor management, alternate strategies, such as     patient self-management, will need to be investigated in a larger scale trial.   "
220294|NCT00735215|"     The sequential administration of endocrine therapies to patients with advanced breast cancer     requires the availability of therapies with different modes of actions, so that tumours     developing resistance to one agent are not cross resistant to another. Because of its     mechanism of action, fulvestrant is distinct from other hormonal therapies, which therefore     limits the possibility of cross-resistance with other therapies such as tamoxifen and the     aromatase inhibitors (AIs)        -  In this way, patients may benefit from an extended period of endocrine treatment, which          has considerable tolerability and quality-of-life advantages over cytotoxic          chemotherapy.        -  In Belgium, fulvestrant is indicated for treating postmenopausal women with hormone          receptor-positive locally advanced or metastatic breast cancer with recurrence during or          after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen          treatment. However, little information is currently available on how fulvestrant is          actually being used by physicians in Belgium. The optimum sequence of endocrine          treatment for advanced breast cancer has yet to be defined and may depend on certain          patient or disease characteristics.      Fulvestrant has been granted reimbursement by the Belgian Health authorities (RIZIV/INAMI)     with the recommendation to collect the real life data necessary to assess the patients'     breast cancer treatment history that may influence the actual endocrine treatment sequence     according to physicians current clinical practice..   "
220295|NCT00735228|"     Hyperglycaemia has been repeatedly associated with risk of mortality and morbidity in the     intensive care unit (ICU). The evidence currently available is in favour of a 'normal ≤ 6.1     mmol/l' level for blood glucose control in ICUs according to two large randomized control     trials of Van den Berghe G and is not supportive of J. Miles's viewpoint in this debate. In     this study, the investigators would like to evaluate that the target of blood glucose level,     whether is a normal level (80-110 mg/dL) or another level (140-160 mg/dL), should be set for     the reduction of perioperative mortality and complications.   "
220296|NCT00735241|"     This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising     a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres     (chemo-radiotherapy, also known as chemo-SIRT), in combination with the biologic therapy     Bevacizumab (Avastin), for the first-line treatment of patients with liver metastases from     colorectal carcinoma in whom surgical resection is not feasible.   "
220297|NCT00735254|"     The purpose of this study is to examine the effect of using a pulsed dye laser (the VBEAM), a     non-ablative laser (the Affirm) and a combination of both lasers to improve the appearance of     your surgical scar. Both the pulsed dye laser and Affirm laser are approved by the US Food     and Drug Administration (FDA) for the treatment of scars. Surgical scars are a type of scar     that can benefit from laser therapy. Redness and the appearance of small blood vessels near     the surface of the skin (telangiectasias) develop in such scars as part of the normal healing     process and usually spontaneously remit, but often slowly and incompletely. In many cases,     lasers can accelerate the clearing of this redness and also improve scar texture.   "
220298|NCT00735267|"     This study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD     0332334 administered in split dose (twice daily) in subjects with Generalized Anxiety     Disorder.   "
220299|NCT00735280|"     The aim of this trial is to evaluate whether a reduction in the heparin dose from 140 to 100     U/kg is associated with a better net clinical outcome in patients undergoing PCI after     pretreatment with 600mg clopidogrel   "
220300|NCT00735293|"     Patients with excessive underarm odor and sweating and/or odor are treated with the VASER     system to determine the VASER's effectiveness in reducing underarm sweat and odor   "
220301|NCT00735306|"     The primary purpose of this trial is to define the maximum tolerated and/or recommended phase     II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy     for carcinoma of the pancreas. An additional primary objective is to describe the frequency     and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary     objectives include describing 1-year disease-free survival and overall survival rates as well     as to estimate clinical and pathologic complete response rates associated with this regimen.   "
220302|NCT00735319|"     Jaundice is the most frequent reason for readmission for healthy newborns after discharge     from the nursery. In the Capital Health area, around 2.5% (315 babies in 2005) of all healthy     newborns were admitted to the hospital for jaundice. Although jaundice is very common, it is     not always a benign condition. If left untreated, it can have devastating consequences     including cerebral palsy and hearing loss. It is therefore critical to be able to identify     the newborns at risk for severe jaundice. So far, heel puncture of blood collection has been     the traditional method to monitor jaundice in newborns. This causes pain to infants,     generates anxiety in parents, and consumes significant health care resources. The aim of this     study is to evaluate the efficacy of a new and noninvasive screening tool, the transcutaneous     bilirubinometer, in detecting babies in our communities who require hospital readmission.     This study will demonstrate whether incorporating transcutaneous bilirubinometer in the home     care program delivered by nurses of Healthy Beginning allows the early detection of babies at     risk of developing severe jaundice at a lower cost and with less discomfort.   "
220308|NCT00735397|"     The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12     mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to     evaluate the maintenance of effect of perampanel for the control of refractory partial     seizures.   "
220309|NCT00735410|"     Annual trial for registration influenza vaccine with the strain composition for season     2008/2009   "
220310|NCT00735423|"     The purpose of this study is to identify neurocognitive functions and language processing of     8-year-old children who were fed either breast milk, milk-based formula or soy-based formula     during the first year of life.   "
220311|NCT00735436|"     The primary objective of the study is to use 24 week survival to assess the efficacy of the     combination of Gliadel followed by Avastin and irinotecan in the treatment of grade IV     malignant glioma patients following surgical resection. The secondary objectives are to     determine the progression-free survival following the combination of Gliadel followed by     Avastin and irinotecan and to describe the toxicity of Gliadel followed by Avastin and     irinotecan.   "
220312|NCT00735449|"     Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive     therapy to Xalatan in subjects with glaucoma or ocular hypertension.   "
220313|NCT00735462|"     The purpose of this study is to determine whether imiquimod creams are effective in treating     external genital warts (EGW). The secondary objective of this study is to provide information     on recurrence of EGW. Additionally the study will also look at any adverse events associated     with the use of the creams.      External genital and perianal warts are caused by the infection of human papillomavirus or     HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like     small flesh-colored, pink, or red growths on or around the external skin of sex organs or     perianal area. The warts may look similar to the small parts of a cauliflower or they may be     very tiny and difficult to see. They often appear in clusters of three or four, and may grow     and spread rapidly. They usually are not painful, although they may cause mild pain,     bleeding, and itching.   "
220314|NCT00735475|"     The purpose of this study is to determine the immunogenicity and safety profile of CSL     Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus     Vaccine.   "
220315|NCT00735488|"     Since 1987, a screening for β Thalassemia in pregnant women is carried on in northern Israel,     and from 1999 all the samples were tested also for Hgb S, Hgb C, Hgb D, Hgb O Arab and     others.      In this study, the investigators intend to summarize the results of this preventive program     aiming to detect couples at risk for having offspring with Thalassemia or SCA, the compliance     regard to genetic counseling and prenatal diagnosis and the incidence of new affected babies     born.   "
220316|NCT00735501|"     This observational study is conducted in Europe. The study aims to observe the incidence of     serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment.   "
220317|NCT00735514|"     RATIONALE: Understanding how well patients comply with their treatment regimen may help     doctors determine best treatment and ongoing care for future patients.      PURPOSE: This phase I study is looking at compliance with vaginal dilation therapy in women     who have undergone radiation therapy for stage IB, stage IIA, stage IIB, stage IIIA, or stage     IIIB cervical cancer or stage IA, stage IB, stage IIA, or stage IIB endometrial cancer.   "
220338|NCT00735787|"     Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to     placebo in adults with chronic plaque psoriasis of the hands and/or feet and the     sustainability of response for 12 additional weeks.   "
220339|NCT00735800|"     Caring for a patient with dementia is associated with increased feelings of burden and     depression. The proposed study will examine the efficacy of Family Intervention: Telephone     Tracking - Dementia (FITT-Dementia), a multi-component, family-based, telephone intervention,     as a tool to reduce caregiver stress.   "
220318|NCT00735527|"     Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening     and requires rapid termination. Early and effective treatment is essential to prevent the     morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of     care for control of SE when administered by intra-venous (IV) route. The investigators intend     to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of     administration of lorazepam. In resource poor settings, sometimes trained personnel or     appropriate equipment for intra-venous cannulation is not available. Alternate routes of     administration, if shown equivalent to conventional IV route, will be very useful in such     settings or for out of hospital management of seizures in children.   "
220319|NCT00735540|"     This study intends to analyze the clinical characteristics of teenagers admitted to pediatric     wards due to organic illness and non organic diagnosis, including patients suffering from     chronic diseases and comorbidity.   "
220320|NCT00735553|"     Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex     25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness     between 50 mg versus placebo, and between 25mg and placebo will be analyzed.   "
220321|NCT00735566|"     Endogenous antiangiogenic factors are related with gastric cancer progression.   "
220322|NCT00735579|"     This clinical observational study investigates the incidence of wound healing abnormalities     in patients undergoing major abdominal surgery. Second aim of the study is, if wound healing     deficits may be accompanied by abnormalities in blood coagulation parameters.   "
220323|NCT00735592|"     The study intends to assess the utility of performing a follow up X rays in children admitted     to pediatric wards with lobar pneumonia. Usually those children are discharged with a     recommendation for a follow up X rays but there are no enough studies proving that this     recommendation is really necessary.   "
220361|NCT00736099|"     The objective of the current study is to investigate the safety and tolerability of BI 1356     (5 mg / once daily) given for 78 weeks in different modalities of treatment.      The treatment modalities are determined by the treatment in the blinded trial in which every     patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI     1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin     background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin     in combination with a sulphonylurea (patients in 1218.18 study)   "
220324|NCT00735605|"     Comparative study between surgical and non surgical treatment of anismus in patients with     symptoms of obstructed defecation.      Anismus is a significant cause of chronic constipation. This study came to compare the     results of BFB training , BTX-A injection and PDPR in the treatment of anismus patients.     Patients and methods: Seventy two anismus patients fulfilled Rome II criteria for functional     constipation were included in this study. All patients underwent anorectal manometry, balloon     expulsion test, defecography, and electromyography activity of the EAS. All patients had non     relaxing puborectalis muscle.. The patients were randomized into three groups. Group I     patients received biofeedback therapy, two times per week for about 1 month. Group II     patients were injected with BTX- A. Group 111 partial division of puborectalis was done.     Follow up was conducted weekly in the first month then monthly for about 1 year.   "
220325|NCT00735618|"     Primary:        -  To characterize the physiologic changes of the autonomic nervous system, demonstrated by          heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a          15 minute, one-time, guided relaxation program for cancer patients.      Secondary:        -  To assess whether change of HRV correlates with subjective feeling for anxiety, based on          visual analog scale scores.   "
220326|NCT00735631|"     The aim of this study is to investigate the accuracy, safety and robustness of a     single-input-single output (SISO) model-based predictive closed-loop system to guide     patient-individualized ICU sedation.   "
220327|NCT00735644|"     This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in     toddlers aged 12-18 months.      Primary objective:      To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi     pasteur.      Secondary objective:      To describe the safety of vaccination in all subjects   "
220328|NCT00735657|"     Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for     patients undergoing Pars Plana Vitrectomy.   "
220329|NCT00735670|"     This study was initially designed to test the efficacy of Venlafaxine HCl in reducing     incidence of the onset of major depression after a new spinal cord injury (SCI). After     several protocol modifications, the purpose of the study is to test the effectiveness of a     sub-therapeutic dose of Venlafaxine HCl to reduce mild to moderate symptoms in persons with     SCI.   "
220330|NCT00735683|"     This primary purpose of this study is to determine if ATHX-105 phosphate causes weight loss     over a 12-week period.   "
220331|NCT00735696|"     The purpose of this study is to evaluate the progression-free survival (PFS) rate at 6 months     of ramucirumab administered in combination with paclitaxel and carboplatin as first-line     therapy for Stage IIIB or IV non-small cell lung cancer   "
220332|NCT00735709|"     The purpose of this study is to determine the effectiveness and safety of vortioxetine, once     daily (QD), in patients with Major Depressive Disorder.   "
220333|NCT00735722|"     Concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF     undergoing CABG will be superior in restoring SR, compared with patients with persistent or     long standing persistent AF undergoing CABG treated with best medical treatment according to     ACC/AHA/ESC 2006 guidelines and no AF ablation.   "
220334|NCT00735735|"     The purpose of this study is to compare the levels of Substance P in saliva, in patients with     severe chronic low back pain and in subjects without it. In addition, to explore a possible     cutoff point, in order to define normal and pathological levels of Substance P in saliva. The     ultimate objective would be to design a measurement method for use in routine clinical     practice.   "
220335|NCT00735748|"     The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol     perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during     the first 6 hours postoperatively and to investigate the time course and accuracy of pain     relief versus the onset and duration of side effects. The first unit dose will be     administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is     reached. The second and third unit dose will be administered after 1 and 2 hours,     respectively, when a VAS of more than 3 is observed.   "
220336|NCT00735761|"     The purpose of this study is to evaluate the episode duration of a herpes labialis recurrence     in immunocompromised patients treated with ME-609 or Acyclovir.   "
220337|NCT00735774|"     The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron     emission tomography tracer.   "
220340|NCT00735813|"     Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire     duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent     complications of long term TCVC are catheter related blood steam infections. Taurolock is a     new lock that is claimed to prevent the formation of luminal biofilm in TCVCs and has been     demonstrated to eradicate infected CVCs. In this study the investigators will compare TCVCs     locked with heparin with TCVCs locked with Taurolock. Hypothesis: Taurolock will diminish the     number of CRBSI in children with cancer compared with children with heparin lock of their     CVC.   "
220341|NCT00735826|"     The primary aim is to study the effects of vorinostat on cyclin E, cyclin D1 and Ki-67     expression in lung, bronchial epithelium, and lung tumors of patients with resectable     clinical stage I - III lung cancer. Secondary aims are: To evaluate the concentration of     vorinostat in tumor tissue and to correlate lung tissue distribution with the plasma level in     these patients; to perform exploratory analyses of the effects of vorinostat on the induction     of apoptosis or necrosis in treated as compared to untreated tumors and on expression of p21,     p27, EGFR and phospho-EGFR in lung tumors of patients with resectable clinical stage I - III     lung cancer; to perform dynamic contrast enhanced CT of the primary tumor to study the     effects of treatment on the vascular supply of the tumor and to correlate the results with     the intratumoral vorinostat concentrations.   "
220342|NCT00735839|"     This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.   "
220343|NCT00735852|"     This is a single-centre, open-label, within patient comparison study to assess the efficacy     and safety of Decapeptyl SR when administered in combination with Livial for the treatment of     women with chronic cyclical pelvic pain. This will be for a 2 year period with a 6 month post     treatment follow up. The study aims to recruit 40 patients.   "
220344|NCT00735865|"     To determine if the types and amount of bacteria or other germs change over time after the     routine procedure of blockage of tear drainage duct in the treatment of dry eye condition or     other condition benefiting from a tear drainage blockage   "
220345|NCT00735878|"     Primary Objectives:      The primary objectives of this study are as follows:      • To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of     escalating ABT-751 in combination with fixed dose carboplatin in patients with advanced non     small cell lung cancer (NSCLC).      • To evaluate the efficacy of the combination with ABT-751 and carboplatin in patients with     advanced NSCLC      • To determine the median survival in the study population      Secondary Objectives      The secondary objectives are:      • To characterize the pharmacokinetic profile of ABT-751 given in combination with     carboplatin in a subset of patients, treated at the MTD or recommended doses for Phase 2.      • To determine the pharmacodynamics of ABT-751 as a single agent and the combination of     ABT-751 and carboplatin as evaluated by cell cycle analysis of buccal mucosa cells.   "
220346|NCT00735891|"     This is a randomized, open-label, multicenter study for patients with advanced or metastatic     non-small cell lung cancer (stage IIIB or IV). The objective of this study is     progression-free survival of bevacizumab and pemetrexed compared to pemetrexed monotherapy     during second-line treatment of Stage IIB or IV non-small cell lung cancer.   "
220347|NCT00735904|"     This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows     activity and is safe in patients with squamous type of non-small cell lung cancer   "
220348|NCT00735917|"     This phase II trial is studying how well saracatinib works in treating patients with     previously treated metastatic pancreatic cancer. Saracatinib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
220349|NCT00735930|"     This phase I trial studies the side effects and best dose of lenalidomide when given together     with alvocidib in treating patients with relapsed or refractory B-cell chronic lymphocytic     leukemia or small lymphocytic lymphoma. Lenalidomide may stop the growth of leukemia or     lymphoma by blocking blood flow to the cancer. Alvocidib may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth. Giving lenalidomide together with     alvocidib may kill more cancer cells.   "
220350|NCT00735943|"     The objective of this observational study is to evaluate the effectiveness and safety of     Macugen for treatment of wet age-related macular degeneration (AMD) in Indian     patients.Prospective, Observational, Non-interventional Study. The period of observation for     the study will be 1 year   "
220351|NCT00735956|"     Purpose of the study:      This is a pilot randomized controlled trial to identify methods of involving underage youth     in interventions to reduce alcohol use through the primary health care system. The trial will     compare the effectiveness of using an onsite behavioral health specialist for screening,     intervention and referral with basic written information and staff recommendations typically     provided in primary care offices.   "
220352|NCT00735969|"     This study will evaluate the effectiveness of an experimental treatment regimen for hepatitis     C (HCV). Standard treatment consists of combination therapy with ribavirin, taken by mouth     twice a day, and Peginterferon, injected under the skin once a week. Hepatitis C genotypes 2     and 3 have a high success rate with this regimen, while genotype 1 is more difficult to     treat. This study will determine if patients with genotype 1 respond better to treatment that     uses a higher dose of ribavirin than the standard approved dose of 1,000 to 1,200 mg daily.      Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been     successfully treated with a standard course of Peginterferon and ribavirin may be eligible     for this study. Participants eligible will receive Peginterferon plus twice the standard dose     of ribavirin (2,000 to 2,400 mg daily) for 48 weeks. In addition to treatment, all patients     receive undergo the following:      Before Treatment:        -  Medical history and physical examination, symptom questionnaires, blood tests, urine          collection, chest x-ray, electrocardiogram, liver ultrasound, Fibroscan (ultrasound to          measure stiffness of the liver) and pregnancy test for women who are able to have          children.        -  Patients with other medical conditions or special risk factors may have further          evaluations before starting treatment. These may include, for example, eye evaluation          for patients with diabetes, exercise stress test for people over age 40 or who have risk          factors for heart disease and psychiatric evaluation for people who have depression or          anxiety disorder.      During Treatment        -  Periodic blood tests to monitor blood counts and viral levels.        -  Outpatient clinic visits every 4 weeks for the duration of the study for laboratory          tests and review of symptoms and treatment side effects. Physical examinations and urine          tests are done every 12 weeks.      Following Completion of Treatment      About 1 1/2 years after starting treatment, subjects are re-evaluated as they were at the     start of treatment.   "
220353|NCT00735995|"     The purpose of this study is to assess the effectiveness of a cognitive-behavioral     intervention for children aged 7 to 12 years with anxiety disorders who are referred to     ordinary community clinics. The treatment will be conducted as individual therapy or group     therapy.   "
221853|NCT00748644|"     Study of the efficacy of rituximab for maintenance treatment in systemic ANCA-associated     vasculitis: prospective, multicenter, controlled, randomized comparative study of rituximab     versus azathioprine   "
220355|NCT00736021|"     The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of     chronic post-traumatic stress disorder (PTSD) in adult civilian survivors of traumatic     events.      Forty survivors of carefully documented traumatic events who had been followed for more than     two years and have not improved will receive up to 40 mg of Escitalopram (daily) for twelve     weeks      Symptoms of PTSD, depression, anxiety disorders, quality of life and global clinical     impression, as well as emergent side effects will be recorded every two weeks (one week for     the first four weeks.      The primary outcome measure will be symptoms of PTSD as recorded at the end of the study (or     the last meeting with the patient - Last Observation Carried Forward).      The secondary outcome criteria will be treatment continuation, as expressed in the proportion     of patients leaving the study for either lack of effect or side effects.   "
220356|NCT00736034|"     The primary objective of this trial is to assess the ability of Phosphatidylserine-Omega3 to     improve cognitive performance in elderly subjects with memory impairment.      This study is a single-center, open-label 15 weeks duration trial to assess efficacy of     Phosphatidylserine-Omega3 in elderly subjects with memory impairment.   "
220357|NCT00736047|"     This study is designed to determine the efficacy of high nicotine-specific antibody titers in     smoking cessation.   "
220358|NCT00736060|"     This study will summarized the clinical and laboratory data and the outcome of all the     patients suffering from Sickle Cell Anemia (Including Sickle cell thalassemia) admitted to     the pediatric ward.   "
220359|NCT00736073|"     The purpose of this study is to determine if giving Aprepitant 4 hours before and for two     days after ERCP decreases the risk of developing pancreatitis after ERCP.   "
220360|NCT00736086|"     To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous     diagnostic procedure.   "
220703|NCT00742170|"     This single-blind, randomized clinical trial tests whether electroacupuncture, provided as an     adjunctive treatment, improves outcomes among patients receiving inpatient opioid     detoxification from opioids.   "
220362|NCT00736112|"     The questioned proposed by this study is one of treatment: To what extent does simultaneous     BMT (Bilateral Myringotomy with Tympanostomy Tubes), adenoidectomy, and diagnosis/avoidance     of food allergy affect the frequency of recurrent otitis media (ROM) versus the standard     academy approach (tube insertions only) to chronic otitis media with effusion; furthermore,     are adenoids a factor in OME or is food allergy diagnosis and treatment able to significantly     prevent ROM after the tubes fall out?      The trial seeks to provide evidence that the treatment for Chronic OME in children should     involve surgical procedures (BMT +/- adenoidectomy), as well, as a food allergy work-up and     subsequent avoidance of the offending foods in order to significantly decrease ROM.      To answer this question, a prospective, randomized controlled trial needs to be conducted.     Since a majority of OME patients are from the pediatric population, parental consent must be     obtained. Subjects in our study will initially present to the clinic with otitis media     symptoms and diagnostic tests such as a tympanogram, otoscopy, and history of recurrent     otitis media will be obtained. Once the surgical decision for bilateral myringotomy and     tympanostomy tubes has been made, parents will be informed about the trial. The standard     protocol for children presenting with initial Chronic OME is to perform a BMT. Therefore,     data from the control group (Group 1) will be obtained from faculty ENT who follow the     academy's recommendations. Data from Group 2 and 3 will be collected from other ENT faculty     members, including the faculty co-investigator who will perform the BMT and obtain a food     allergy blood draw at the time of surgery. The study's faculty co-investigator will describe     food avoidance techniques to post-op patients from Groups 2 and 3. Patients with previous     adenotonsillar surgery or placement of tympanostomy tubes will not be enrolled in the study.     The incidence of ROM episodes in all trial groups will be recorded.   "
220363|NCT00736125|"     The purpose of this study is to determine if the use of a carbon dioxide lavage device     (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic     events when compared with standard orthopedic techniques.   "
220364|NCT00736138|"     Effects of training and pellots   "
220365|NCT00736151|"     The purpose of this study is to examine the effects of various increasing doses of     Ralfinamide in patients with neuropathic pain.   "
220366|NCT00736164|"     RATIONALE: Selenomethionine may slow the growth of prostate cancer. Giving selenomethionine     before surgery or internal radiation therapy may be an effective treatment for prostate     cancer.      PURPOSE: This randomized phase II trial is studying how well selenomethionine works in     treating patients undergoing surgery or internal radiation therapy for stage I or stage II     prostate cancer.   "
220367|NCT00736177|"     This study seeks to determine if patients with a history of failed fresh embryo transfer(s)     will have increased success rates with embryo cryopreservation and subsequent thawed embryo     transfer when compared to fresh embryo transfer.   "
220368|NCT00736190|"     The purpose of this study is to evaluate the antiviral activity and safety of tenofovir     disoproxil fumarate (TDF) in Asian-American adults (self-reported Asian descent, living in     the United States) with chronic hepatitis B infection. All participants will receive active     treatment with TDF for 48 weeks.   "
220369|NCT00736203|"     The purpose of this study is to obtain a database of brain function from a sample of     non-smokers while they do tasks in an MRI (magnetic resonance imaging) machine. Our     hypothesis is that among nonsmokers, reactivity to smoking cues will be highly similar to     control cues but may vary as a function of attitudes toward smoking and/or family history of     smoking. We also hypothesize that brain activity during the n-back task will be more similar     to data collected during this task when smokers are not abstinent.   "
220370|NCT00736216|"     RATIONALE: Learning about young adults' knowledge and perceptions about risk factors for the     human papilloma virus and cervical cancer may help doctors learn more about how to prevent     human papilloma virus infection and cervical cancer in the future.      PURPOSE: This clinical trial is studying knowledge and perceptions of the risk factors for     human papilloma virus infection and cervical cancer in young adults.   "
220371|NCT00736229|"     The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in     hyperglycemic patients admitted to the coronary intensive care unit.   "
220380|NCT00736346|"     The purpose of this study is to assess the impact of three different treatment modalities on     panic symptoms, quality of life and use of health services among individuals consulting an     emergency department for non cardiac chest pain and having Panic Disorder.   "
220372|NCT00736242|"     The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b     (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human     Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Participants were treated by     general practitioners in clinical practice as part of the post-marketing surveillance study.     The study assessed the rates of eradication of the HCV and the rates of serious adverse     events reported with PEG-IFN alfa-2b (1.5 ug/kg/week) and RBV (800-1200 mg/day) in common     medical practice in Germany.   "
220373|NCT00736255|"     The overall goal of the present project is to investigate whether lisdexamphetamine (LDX;     Vyvanse) is an effective adjunct to nicotine replacement therapy (NRT) to promote smoking     cessation in patients with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and     nicotine dependence. The investigators hypothesized initially that smokers with ADHD who are     optimized to a dose of LDX prior to quitting smoking and who remain on this dose of     medication after quitting will remain abstinent longer than patients who are treated with     placebo before and after quitting.However due to recent key issues that have arisen showing     that initiation of stimulant treatment while subjects are actively smoking may facilitate     increased smoking, and given that the study was still in the very early stage of study     execution, the investigators revised the study design to use an empirically validated     pretreatment approach with NRT and to initiate LDX treatment on the first post quit date in     order to reduce the withdrawal symptoms that accompany smoking cessation. The overall     rationale for this revised study design remains similar to the original.   "
220385|NCT00736424|"     The purpose of this study is to collect subject data to evaluate the rate of sudden     unexplained death in epilepsy (SUDEP) with bilateral neurostimulation of the anterior nucleus     of the thalamus in people diagnosed with refractory epilepsy. The data obtained from the     physician initiated studies will be pooled with data collected in Medtronic-sponsored studies     to assess SUDEP risk.   "
220386|NCT00736437|"     The primary objective was to compare the efficacy of ME-609 cream vs placebo cream on the     time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions     experimentally induced after ultra violet radiation (UVR) exposure.   "
220427|NCT00736970|"     This clinical trial will study the use of ridaforolimus in metastatic breast cancer subjects     whose tumors have shown a resistance to trastuzumab (herceptin). The goal of this study is to     find out if subjects treated with ridaforolimus in combination with trastuzumab have a     positive response to the treatment, and if treatment with ridaforolimus in combination with     trastuzumab prolongs survival.   "
220374|NCT00736268|"     This study is an NIH-funded clinical trial conducted at Duke University Medical Center and     Ohio State University. The purpose of this study is to examine the effects of a     telephone-based, care-giver assisted, coping skills training (CST) program in patients with     Chronic Obstructive Pulmonary Disease (COPD) and their caregivers. This may help COPD     patients and their caregivers to deal better with the stress of lung disease. This study will     test 3 primary hypotheses: 1) That enhanced CST will be more effective in improving quality     of life compared to a Usual Medical Care plus COPD education and symptom management control     group; 2) That enhanced CST will be associated with better medical outcomes (i.e., greater     survival and fewer COPD-related physician visits or hospitalizations) compared to Controls     over a follow-up period of up to 4 years; and 3) That improvements in quality of life and     survival will be mediated by increased functional capacity and better coping.      This proposed study builds upon our prior research by: a) adapting and refining our CST     protocol, which was effective in improving psychosocial adjustment in patients awaiting lung     transplantation, to a broader population of patients with COPD who are not immediate     candidates for lung transplantation; b) enhancing our intervention to improve functional     capacity, reduce somatic symptoms, and improve survival; c) examining the impact of CST on     medical expenditures; and d) including caregivers in an enhanced CST intervention.   "
220375|NCT00736281|"     The questions proposed by this study are those of safety and efficacy.        1. Concerning safety: Are sublingual food drops (SLIT) safe enough to be used for          stimulation of natural immune suppression in patients with food allergies?        2. Concerning efficacy: Do the drops suppress food allergy enough for patients to eat          previously allergic foods with little or no allergic reaction?      The aim of this trial is to provide systematic collection of data proving the safety and     efficacy of food drops in the correction of food allergy. A patient's range of symptoms,     which can include but are not limited to fatigue, nausea, vomiting, diarrhea, abdominal pain,     and insomnia can be diagnostic indicators of food allergies.      An approach to answering the above questions can be done by a randomized, controlled, blinded     study. The design of our study could be reasonable and powerful because this layout limits     bias and accounts for placebo effects:      The patients enrolled in our study will present with food allergy symptoms and diagnostic     tests will provide the specific information regarding their food allergies. Once the     diagnosis has been made and consent for treatment has been obtained, participants will be     randomly assigned to either the group that receives the food allergy intervention with SLIT (     food allergens mixed with 50% glycerin in a vial) or the group that receives the control SLIT     (glycerin only). The patients are truly blinded to their treatment because all the SLIT food     allergy vials are identical and contain no distinguishing features that could reveal their     contents. There is also no difference in taste between a vial containing glycerin and food     allergens and a vial containing only glycerin. Therefore, a food allergy SLIT     randomized-controlled study can be reasonably achieved.   "
220376|NCT00736294|"     Atrial Flutter [AFL] is a relatively frequent arrhythmia, considered as benign, but     associated with both invalidating symptoms and thromboembolic risk. The objective of the     treatment consists to on the one hand the sinus rhythm [SR] restoration and on the other hand     the prevention of the long-term recurrence. In this clinical setting, AFL radiofrequency     ablation [RFA] became the first line therapy due to its both high effectiveness and safety.     The effectiveness of AFL RFA is attenuated by the subsequent risk of atrial fibrillation     [AFib] close to 25% at 1 year. This risk of subsequent AFib is related to the common     substrate between both arrhythmias.      When AFib occurs, the interest to maintain the SR is still required, even if recent studies     did not show a significant difference in term of total mortality between rate or rhythm     control strategies [AFFIRM, RACE and PIAF studies]. The studies published underlined the     anti-arrhythmic drugs limits in patients with both arrhythmias [AFib and AFL]. After years     centered on the mechanisms and the electric treatments of AFib, researchers are nowadays     focusing on the study's evaluation of the atrial tissue substrate.      Accordingly, the renin-angiotensin system role was investigated in many works. Indeed,     angiotensin II plays a role in the modification of atrial pressure and in the fibers     stretching [stretch], conditions required for the development of AFib. Angiotensin II is     also a factor implied in the tissue fibrosis leading to tissue proliferation and collagen     alteration. These mechanisms lead to atria cells conduction disorders and refractory periods     modification. Moreover, the enzyme of conversion expression and the angiotensin II receptors     deterioration were observed in patients with AFib.      This brings to the concept of AFib treatment while interfering on tissue remodeling by the     way of renin-angiotensin system. Drugs such as the angiotensin converting enzyme inhibition     [ACEI] may reduce AFib in patients with heart failure. No randomized study so far has     compared the ACEI drugs against placebo among high-risk patients of AFib in post AFL RFA     area. On the basis of experimental and clinical study, the investigators seek to evaluate the     ACEI use in the prevention of AFib in an AFL post RFA ablation.   "
220377|NCT00736307|"     The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex     vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface     reconstruction in cases of partial and sever limbal stem cell deficiency.   "
220378|NCT00736320|"     This study is designed to test the non-inferiority of the experimental arm compared to the     standard arm in terms of Progression free survival (PFS).   "
220379|NCT00736333|"     This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of     metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar     erythrodysesthesia (PPE).   "
220381|NCT00736372|"     PX-12 (1-methylpropyl 2-imidazolyl disulfide) is a novel small molecule inhibitor of     thioredoxin-1, a small protein over-expressed in many human cancers that is associated with     aggressive tumor proliferation, angiogenesis, and drug resistance. This study is being     conducted to determine the maximally tolerated dose of PX-12 delivered as a 72-hour infusion     over days 1, 2, and 3 of a 21-day cycle in patients with advanced or metastatic cancer.   "
220382|NCT00736385|"     The purpose of this study is to find out if Metformin is safe and useful in the treatment of     NAFLD.   "
220383|NCT00736398|"     This is an observational study to assess clinical outcomes in patients who undergo spinal     fusion. Patients who are already scheduled for spinal fusion will enroll in the study.     Information about prior therapies will be collected, and then patients will be followed to     see how they do after spinal fusion. This study will help researchers better understand the     natural course of patients who patients who undergo spinal fusion surgery.   "
220384|NCT00736411|"     The aim of this investigation is to determine the value of combining acupuncture with     infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure     the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and     pregnancy and live birth rates.   "
220397|NCT00736580|"     This study is assessing whether there is a decrease in surgical glove punctures using blunt     tipped needles compared with sharp needles for suturing during Cesarean Delivery.   "
220387|NCT00736450|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Oblimersen sodium may     help chemotherapy work better by making cancer cells more sensitive to the drugs. Giving     oblimersen sodium together with combination chemotherapy may kill more cancer cells. PURPOSE:     This clinical trial is studying the side effects of giving oblimersen sodium together with     combination chemotherapy and to see how well it works in treating patients with newly     diagnosed stage I, stage II, stage III, or stage IV diffuse large B-cell lymphoma   "
220388|NCT00736463|"     Summary:      Background: There is a lot of interest in the function and role of HDL to prevent and     mitigate atherosclerosis in patients who are at or near LDLc targets. Statins have variable     effects on HDLc which are accentuated in patients with a low baseline HDLc. Higher doses of     statins are being used more commonly in practice based on newer outcomes studies which find     greater benefits of the higher doses compared to lower or standard doses. This study is     testing FDA approved dosages of two commonly used statin medications.      Design: The study is designed to examine the effects of 80mg simvastatin and 80mg     atorvastatin on HDLc concentrations. Serum will be saved for a hopeful collaborative effort     with investigators at the U. of Washington who are able to do more advanced testing of HDL     particle functionality. Based on the first 13 patients studied at Indiana University, the     effects of these statins on HDLc concentrations vary greatly. It is unknown what impact these     concentration changes have on the functionality of the particles however. A meta-analysis of     4 prospective trials published in JAMA in 2006 found that increasing HDLc with statins was     independently associated with regression of atherosclerosis as measured by intravascular     ultrasound.      Patients: Patients with low HDLc will be the primary population recruited. Exclusion criteria     include interacting medications, pregnancy, baseline hepatic disease or other illnesses which     would put patients at increased risk of statin side effects.   "
220389|NCT00736476|"     To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine,     compared with placebo.   "
220390|NCT00736489|"     The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199     in asthmatic patients.   "
220391|NCT00736502|"     The aim of this trial is to evaluate the safety and virological and immunological efficacy of     Viramune® on a background of different antiretroviral drug combinations.   "
220392|NCT00736515|"     In recent years, with the further research of the pathogenesis of diabetes mellitus and the     mechanism of oral antidiabetes drugs, the early combination therapy of oral antidiabetes     drugs and insulin is getting paid more and more attention. A lot of studies have confirmed     that Gliclazide MRs have excellent reducing blood glucose efficacy and vascular protection.     Based on these theory and practice, this study is designed to demonstrate whether the     combination therapy of Gliclazide MR and basal insulin can control the blood glycemia     effectively and reduce the dosage of insulin and the hypoglycemia events compared to the     premix insulin monotherapy.   "
220393|NCT00736528|"     To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration     of multiple, ascending, oral doses to healthy elderly subjects.   "
220394|NCT00736541|"     N-acetylcysteine (NAC) is used to treat Tylenol toxicity. NAC is a rich source of the     sulfhydryl group (SH) which is important for replenishing the body's glutathione stores.     Glutathione acts as a free radical scavenger, to decrease the damage that would be caused by     those toxic radicals. Patients who undergo orthotopic liver transplantation (OLT) have a high     incidence of post-operative renal dysfunction. The most common etiology of post-operative     renal dysfunction is related to high levels of toxic free radicals. Free radicals may     contribute to primary liver graft failure or delayed liver graft function.      Specific Aims & Objectives:      The primary objective of this study is to evaluate the efficacy of NAC in improving liver     graft performance and lowering the incidence of post-operative renal dysfunction. The     secondary objectives are to investigate the effect of NAC on endogenous glutathione body     stores and its effect on FK506 induced toxicity.   "
220420|NCT00736879|"     The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can     help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well     controlled on diet and exercise alone. The safety of this treatment will also be studied   "
221289|NCT00749528|"     The purpose of this study is to evaluate hair trace elements and toxic metals and plasma     total antioxidant activity in children with recurrent wheezing and to evaluate whether these     toxic metals and trace elements have any impact on serum cytokine levels.   "
220395|NCT00736554|"     Staphylococcus aureus is the most common bacteria responsible for skin, bone, and muscle     infections. Recent studies from the United States have suggested that a type of this     bacterium called methicillin resistant S. aureus (MRSA) has become dramatically more common,     especially the community strain. However, Canadian data is still largely lacking. This study     aims to determine the prevalence of community acquired (CA) MRSA among patients presenting     with skin and soft tissue infections to the Urgent Care Center and Emergency Departments in     London, Ontario. This will be determined by taking swabs at enrollment from patient's noses,     throats, and sites of infection. Patients will be asked to complete a health questionnaire     with the goal of identifying risk factors associated with CA-MRSA. Through follow-up swabs of     participants' noses and throats at one and three months, the effects of treatment on     patient's carrying MRSA will be determined. Results may be used to form guidelines for     empirical S aureus treatment in the region, reducing possible morbidity and mortality from     delayed or suboptimal treatment of CA-MRSA infections. Improved understanding of risk factors     associated with MRSA infection in a Canadian setting, may also change the practice of     physicians considering empiric antibiotic therapy for skin and soft tissue infections.   "
220396|NCT00736567|"     PATH is a member of a consortium that is developing a Diagnostic Enterics Card (DEC) which     will allow clinicians to diagnose a group of diarrheagenic pathogens linked to morbidity and     mortality. The pathogens detected on DEC include Salmonella, Campylobacter jejuni, Shigella     species, and Escherichia coli O157:H7. This study will evaluate the performance of the assays     and the platform in clinical conditions with non-expert users. It will provide important data     on the performance of DEC for at least one target pathogen, an understanding of the potential     impact of different sample types on device performance, and human factors associated with     instrument interface in the field.   "
220398|NCT00736593|"     Nexagon™ is a novel compound that promotes wound healing by temporarily disrupting cellular     communication at the wound site, thereby promoting accelerated healing, reducing inflammation     and pain. This randomized double-blind study will assess the safety, tolerability and     clinical effect of Nexagon™ when applied to skin wounds created by punch biopsy in healthy     volunteers. 43 healthy, fair-skinned males and females between ages 18-40 will be enrolled.     Subjects will be reviewed again at 3 months and 9 months for follow-up safety assessments and     wound appearance evaluation.   "
220399|NCT00736606|"     The purpose of the study is to assess the pharmacokinetics of both AZD9056 (steady state) and     simvastatin (single dose) when co-administered in healthy volunteers   "
220400|NCT00736619|"     For patients with this type of cancer, one standard treatment option is cetuximab (Erbitux®)     + radiation. We wish to study the addition of albumin-bound paclitaxel (Abraxane®) to this     standard regimen of cetuximab + radiation. Albumin-bound paclitaxel and cetuximab both are     chemotherapy drugs which are administered by vein.      Previous studies have shown that albumin-bound paclitaxel can kill head and neck cancer cells     when given alone or in combination with chemotherapy. The purpose of this study is to     establish a safe dose range of albumin-bound paclitaxel given in combination with cetuximab     and radiation therapy. The investigators want to find out what effects, good and/or bad, the     albumin-bound paclitaxel has on you and your head and neck cancer.   "
220401|NCT00736632|"     In recent years, vitamin D has been shown not only to be important for bone and calcium     metabolism but also for homeostasis of critical tissues involved in vascular disease in     patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D     deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease     and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the     effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D     deficient hypertensive patients with diabetes   "
220402|NCT00736645|"     RATIONALE: Selenomethionine may slow the growth of prostate cancer. Testosterone can cause     the growth of prostate cancer cells. Finasteride may fight prostate cancer by lowering the     amount of testosterone the body makes. Giving selenomethionine together with finasteride     before surgery or radiation therapy may be an effective treatment for prostate cancer.      PURPOSE: This randomized phase II trial is studying how well selenomethionine and finasteride     work when given before surgery or radiation therapy in treating patients with stage I or     stage II prostate cancer.   "
220403|NCT00736658|"     This is a single centre, double-blind, randomised, parallel group, placebo controlled study     to assess the safety, tolerability and pharmacokinetics of AZD1386 when given as multiple     doses to 32 (24 healthy young and 8 healthy elderly) Japanese subjects. For young healthy     subjects (aged ≥20 to ≤45 inclusive) 3 consecutive multiple ascending dose panels are     planned. For elderly healthy subjects (aged ≥65 to≤80 inclusive) 1 multiple dose panel is     planned.   "
220404|NCT00736671|"     This research study will evaluate functions of memory, thinking, eye movements and walking     and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in     the brain using an imaging procedure called positron emission tomography (PET). You may know     that the brain chemical dopamine, a neurotransmitter substance (a chemical messenger that     nerve cells need to communicate with each other), is important for the brain to control     movements and that the brain chemical acetylcholine may have functions related to mental     concentration and attention. At the present time, the investigators have no clear information     how these two chemicals in the brain of patients with Parkinson's disease are related to the     risk of falling.   "
220405|NCT00736684|"     The purpose of this study is to compare rates of any fracture fixation complication and     revision rates after intramedullary fixation of unstable trochanteric fractures between the     Proximal Femoral Nail Antirotation™ (PFNA)(Investigational Group) and Gamma Nail 3™ (Gamma3)     (Control Group).   "
220406|NCT00736697|"     The primary objective of this study is to assess the effect of a high-fat meal (breakfast) on     the concentrations of moxidectin measured in the blood after a single oral administration in     healthy subjects.   "
220450|NCT00737269|"     The purpose of this registry is to better understand (1) complicated skin and soft-tissue     infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized     patients receiving intravenous antibiotic therapy.   "
220407|NCT00736710|"     Patients with schizophrenia have high rates of cigarette smoking and tobacco dependence, and     great difficulties in quitting smoking. The development of novel and more effective     treatments for tobacco dependence in this population is thus needed. This study will test the     hypothesis that repetitive transcranial magnetic stimulation (rTMS) may facilitate smoking     cessation with the transdermal nicotine patch (TNP) in patients with schizophrenia motivated     to quit smoking. A total of N=40 smokers with schizophrenia would be assigned to either     active rTMS (N=20) or sham rTMS (N=20) as a treatment regimen of 5X/week treatments for four     weeks. All subjects would receive TNP (21 mg/24h) and weekly group behavioral therapy for     smoking cessation for a total of 10 weeks. The investigators predict that active rTMS will be     well-tolerated and superior to sham rTMS for enhancing smoking cessation rates in smokers     with schizophrenia.   "
220408|NCT00736723|"     The purpose of this study is to determine the course of NT-proBNP plasma concentrations in     the context of confounding parameters in postoperative/posttraumatic critically ill patients     with severe SIRS/sepsis and shock.   "
220409|NCT00736736|"     The first purpose was to compare the difference between leg press exercise(LPE) and     additional hip abductor and external rotator muscle strength training to leg press     exercise(LPE+HAE) in muscle strength, hip kinematics during step down, pain severity and     function for patients diagnosed with patellofemoral pain syndrome. The second one was to     discover the relationship between the change in muscle strength performance and the     difference of hip joint kinematics post treatment.   "
220410|NCT00736749|"     This clinical trial keeps track of and collects follow-up information from patients who are     currently enrolled on or have participated in a Children's Oncology Group study. Developing a     way to keep track of patients who have participated in Children's Oncology Group studies may     allow doctors learn more about the long-term effects of cancer treatment and help them reduce     problems related to treatment and improve patient quality of life.   "
220411|NCT00736762|"     The postural alterations present in the seniors people act as predisponent form of     incapacities that provoke alterations in the quality of life. The objective of this study is     to evaluate the biomechanical characteristics of the balance of elderly people, before and     after treatment with Global Postural Re-education. This research is characterized by     experimental method of investigation.Thirty elderly people (30 women) will be randomized to     two different groups from Group of Studies of Third Age - GETI, at University of the State of     Santa Catarina:        -  fifteen elderly women will be submitted to the Global Postural Re-education (GPR)          program and to the GETI program of activities        -  fifteen elderly women will be submitted only to the GETI program of activities.      At baseline the subjects will be screened for balance measurements with the chattecx balance     system and Berg Scale. These measurements will be repeat immediately after the intervention.     The subjects randomised to the GPR program will participate in posture retraining techniques     of approximately forty minutes, one time a week for ten weeks. The independent t test for     pairs of random samples will be used, with level of significance of p≤0,05.   "
220412|NCT00736775|"     This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study that will     be conducted in the United States and consists of a single ascending-dose stage followed by a     multidose, parallel-treatment stage. This study will be conducted in approximately 50 adult     patients between 50-85 years old who have mild to moderate Alzheimer's disease.   "
220413|NCT00736788|"     The primary objective of this study is to investigate the safety and tolerability of AZD1704     following single ascending doses in healthy Japanese male and non-fertile female volunteers     by assessment of adverse events (AEs), vital signs (supine and standing blood pressure, pulse     rate, respiratory rate and body temperature), safety laboratory variables and 12 lead     electrocardiography (ECG). The secondary objectives of the study are: to investigate the     subjective CNS effects of orally administered AZD1704 in healthy Japanese male and     non-fertile female volunteers on a psychometric rating scale by assessment of specific     adjectives (stimulated, anxious, sedated, down and high) rated on visual analogue mood scale     (VAMS) and to investigate the pharmacokinetic profile of AZD1704 following single ascending     doses in healthy Japanese male and non-fertile female volunteers.   "
220414|NCT00736801|"     BDNF has been linked to the pathogenesis of airway hyperresponsiveness in asthma. In this     trial, the impact of a treatment with salmeterol and salmeterol / fluticasone on BDNF     concentrations will be assessed in patients with asthma. The investigators hypothesize that     salmeterol impacts on BDNF concentrations in patients with asthma.   "
220415|NCT00736814|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. It is not yet known which     combination chemotherapy regimen is most effective in treating non-small cell lung cancer.      PURPOSE: This randomized phase II trial is comparing different combination chemotherapy     regimens to see how well they work as first-line therapy in treating patients with stage IIIB     or stage IV non-small cell lung cancer that cannot be removed by surgery.   "
220416|NCT00736827|"     The purpose of this study is to find out whether acute renal failure is associated with BK     virus reactivation in postoperative/posttraumatic critically ill patients with severe     SIRS/sepsis and shock.   "
220417|NCT00736840|"     This trial is a pivotal trial to validate the use of a 13 C labeled substrate called     methacetin and the BreathID automatic breath testing system, for determination of cirrhosis     in patients with chronic liver disease.   "
220418|NCT00736853|"     The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride     plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis     (a progressive and degenerative joint disease, in which the joints become painful and stiff)     of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which     cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).   "
220419|NCT00736866|"     The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo     for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures     that use contrast.      Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the     procedure.   "
222462|NCT00757159|"     The aim of this investigation is to determine whether a synthetic hydroxyapatite is as     effective as an enamel matrix protein for periodontal regeneration in patients who have     intra-bony periodontal defects.   "
220421|NCT00736892|"     Acute lung injury is a clinical syndrome of rapid onset of acute respiratory failure. It     represents a significant public health issue. Patients with acute lung injury require     admission into critical care units for advanced life support and utilize considerable health     care resources. Published epidemiological studies on acute lung injury in the last 20 years     are difficult to compare because they used different definitions and length of time for     evaluation. Less than five studies have collected information for an entire year, and none of     them have evaluated the degree of oxygenation failure under standard settings. We will     perform a one-year prospective audit of all patients admitted with acute lung injury in     almost 40 ICUs in Spain.   "
220422|NCT00736905|"     The purpose of this study is to investigate the pharmacokinetics (how the drug is absorbed     into the bloodstream, distributed in the body and eliminated from the body) after a single     dose and after repeated administration of TMC278 administered once daily for 11 days in     subjects with mild or moderate hepatic impairment (impaired liver function), compared with     healthy control subjects. Furthermore the short-term safety and tolerability (how well the     body tolerates the drug) of TMC278 will be assessed.   "
220423|NCT00736918|"     This study will determine the effectiveness of continuous follow-up care by case manager in     preventing further suicide attempts   "
220424|NCT00736931|"     The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam   "
220425|NCT00736944|"     This phase two trial will determine the tumor response rate at the primary site and at     involved regional nodes to two cycles of an IC regimen of weekly Abraxane and cetuximab given     in combination with cisplatin and 5-FU in patients with local regionally advanced HNSCC.   "
220426|NCT00736957|"     The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride     plus acetaminophen (JNS013) with long term administration in participants with chronic pain.   "
220429|NCT00736996|"     The purpose of this study is to investigate novel treatments to delay progression to dementia     in patients with mild cognitive impairment (MCI) and metabolic syndrome (MS). The hypothesis     is that treatment with pioglitazone or endurance exercise training will improve, stabilize,     or attenuate decline in cognitive function compared to controls. This study will also     discover potential mechanisms for the improvements and determine the baseline prevalence of     amnestic versus non-amnestic MCI.   "
220430|NCT00737009|"     The purpose of this study is to describe adherence to anastrozole treatment current practice:     cases where anastrozole treatment was halted ( timescale and causes) and estimate the     proportion of postmenopausal women with early breast cancer who continue anastrozole therapy     after one year follow-up.   "
220431|NCT00737022|"     Vitrectomy is one of the major treatment methods for complications of diabetic retinopathy.     As surgical techniques and instruments improve, high anatomical success may be achieved;     however, functional results are less favorable. Despite attached retina, postoperative visual     function may be affected by various macular and disc abnormalities. Major changes include     optic atrophy, atrophic retina, poor macular perfusion, and structural alternations of the     macula. Funduscopy, fluorescein angiography, and, more recently, optical coherence tomography     (OCT) can be used to detect and document these alterations. Although fluorescein angiography     is valuable in the assessment of various macular lesions as well as retinal vascular     abnormalities, its usefulness in evaluating macular changes is limited in eyes that have     undergone diabetic vitrectomy. The quality of the images may be compromised by mild diffuse     hyperfluorescence in the posterior pole in middle and late phase angiography, which obscures     capillary detail and subtle macular changes. Furthermore, quantification of changes may not     be possible. Recently, optical coherence tomography has become very useful for the detection     of vitreomacular abnormalities. The examination is noninvasive, can qualify the changes and     detect subtle abnormalities not evident with other imaging studies.      In this study, OCT was applied to investigate how common macular structure abnormalities are     present after surgery for complications of diabetic retinopathy, and how they may affect     visual prognosis.   "
220432|NCT00737035|"     This study will determine whether a specialized Web site geared for the guardians of children     whose one parent has murdered the other can increase guardian capabilities, reduce guardian     stress, and improve child behavior and mental health.   "
220433|NCT00737048|"     The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral     dose administration in participants with pain after tooth-extraction of mandibular impacted     wisdom tooth.   "
220434|NCT00737061|"     The purpose of this study is to demonstrate the safety & efficacy of the Adiana Transcervical     Sterilization System for women who desire permanent birth control (female sterilization) by     occlusion of the fallopian tubes.   "
220435|NCT00737074|"     Macular hole in proliferative diabetic retinopathy with fibrovascular proliferation may have     unique features. Internal limiting membrane peeling facilitates hole closure only in cases     with shallow macular detachment. Final vision is associated with preoperative visual acuity     and degree of macula elevation.   "
220436|NCT00737087|"     This post-marketing study is designed to collect data relating to the use of the Delta Xtend™     Total Shoulder Replacement System in shoulder with rotator cuff deficiencies. This allows for     continued monitoring of the performance and safety of the prosthesis in a broader range of     clinical situations.   "
220437|NCT00737100|"     This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide     (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on     lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be     based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations   "
220438|NCT00737113|"     The primary objective of this study is to define the safety and efficacy of recombinant human     growth hormone (rh-GH, Genotropin) in a patients undergoing allogeneic transplantation.   "
220439|NCT00737126|"     The development of diabetic nephropathy has been linked to several genetic polymorphisms,     including those related with homocysteine metabolism such as the methylenetetrahydrofolate     reductase (MTHFR)and the cystathionine-beta-synthase genes. Such alterations are associated     with hyperhomocysteinemia, which is a known independent risk factor for the development of     endothelial dysfunction and cardiovascular disease.      In the Mexican population there is a high prevalence of the C677T MTHFR mutation. The     investigators performed this study to evaluate the prevalence of this polymorphism in type 2     diabetic patients with diabetic nephropathy compared with type 2 diabetic patients without     nephropathy, besides evaluating the relationship of hyperhomocysteinemia with endothelial     dysfunction and microalbuminuria before and after the administration of folic acid. We     proposed that the endothelial dysfunction caused by the hyperhomocysteinemia could be     reversed after the administration of folic acid.   "
220440|NCT00737139|"     This study involves research. The purpose of this research is to formally investigate the     hemostatic efficacy of epinephrine to minimize blood loss after total joint arthroplasty. It     is unclear if using intra-articular injections of epinephrine in total joint replacement is     associated with a decrease in post-operative blood loss. The initial hypothesis is: the use     of intra-articular injection of epinephrine is associated with decreased post-operative blood     loss.   "
220441|NCT00737152|"     Rationale: RAS 130 is an anti-diabetic agent used to lower the blood glucose level in Type II     Diabetes mellitus (non-insulin-dependent diabetes) patients with proper diet and exercise.     RAS 130 works by restoring proper response to insulin in the body. RAS 130 acts primarily by     increasing insulin sensitivity which improves glycemic index. It is presumed that RAS 130     does not cause cardiovascular side effects if it is given to Type II diabetes mellitus     patients leading a healthy life style. Specifically, controlling diet is done according to     American Diabetic Association & American Heart Association guidelines and also through doing     aerobic exercises. Guideline for aerobic exercise is given in the design of the study.      Exercise is helpful in controlling body weight which can lower the risk for heart disease.     Diabetes itself is one of the compounding factors for heart diseases. Exercise helps lowering     the LDL cholesterol and raising the HDL cholesterol which is required to prevent heart     diseases and achieve a better quality of life.      Purpose: The aim of this study is to prospectively assess and evaluate the cardiovascular     side effects and reduction of blood glucose levels in the Type II Diabetes mellitus patients     treated with RAS 130, who either met, or failed to meet criteria for diet and exercise.   "
220442|NCT00737165|"     1. The primary goal for this study is to examine the effectiveness of community-based          multimodal intervention program for suicide prevention in relatively high suicide rate          region compared to control region.        2. The secondary goal for this study is to explore the effectiveness of community-based          multimodal intervention program for suicide prevention in the highly populated regions.          In addition, we examine the effectiveness of the prevention program in the all regions          combined.   "
220443|NCT00737178|"     After medication abortion, women may quickly become pregnant again and therefore need an     effective birth control method right away. Intrauterine devices (IUDs) are very effective for     preventing pregnancy. IUDs are usually placed more than a month after abortion. This study     will randomly assign women having a medication abortion to two groups, either having the IUD     inserted one week after medication abortion or having the IUD inserted more than four weeks     later. Women will be followed for six months to compare how many return for IUD placement in     the two groups, how many are using the IUD after six months, experience with pain, bleeding,     and cramping, how easy or difficult it is to insert the IUD, how many IUDs are expelled or     removed, and how many women are using any birth control six months after the abortion.   "
220444|NCT00737191|"     RATIONALE: Opioids lessen pain caused by cancer. It is not yet known whether opioids are more     effective when given together with or without olanzapine in treating cancer pain.      PURPOSE: This randomized clinical trial is studying opioids to see how well they work when     given together with or without olanzapine in treating patients with moderate to severe cancer     pain.   "
220445|NCT00737204|"     This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is     effective in reducing fatigue in adults with HIV/AIDS.   "
220446|NCT00737217|"     This research study will evaluate functions of memory, thinking, behavior, and daily life     activities and how these relate to the measurement of certain chemicals (acetylcholine and     dopamine) in the brain using an imaging procedure called positron emission tomography (PET).     You may know that in Alzheimer's dementia (dementia is a disease where persons become     forgetful and confused), a reduction in the amount of acetylcholine, a neurotransmitter     substance (a chemical messenger that nerve cells need to communicate with each other), may be     responsible for some of the memory and behavioral changes. At the present time, the     investigators have no clear information on the levels of acetylcholine in the brain of     patients with Parkinson's disease who also have memory or behavioral changes.   "
220447|NCT00737230|"     RATIONALE: A step-by-step procedure may help health care practitioners diagnose and treat     cancer patients with bowel injury symptoms caused by radiation therapy.      PURPOSE: This randomized clinical trial is studying the care of cancer patients with bowel     injury caused by radiation therapy to the pelvis.   "
220448|NCT00737243|"     This is a non-randomized Phase II study. Patients determined at initial diagnosis to have a     carcinoma of unknown primary site (CUP) will have their treatment selected with the use of a     molecular profiling assay. The assay will be performed on paraffin-embedded tumor tissue from     a biopsy specimen. Patients given specific diagnoses (e.g., lung, pancreas, colon, breast,     renal cell, prostate and ovarian cancer) will receive treatment regimens of proven activity.     If no specific diagnosis is made with the molecular profiling assay, empiric chemotherapy     with paclitaxel, carboplatin, bevacizumab and erlotinib will be administered.   "
220449|NCT00737256|"     The purpose of this study is to gather systematic clinical data on whether aripiprazole, a     partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence     subjects. Since aripiprazole has established effects against schizophrenia, the study focuses     on whether aripiprazole concurrently reduces co-morbid cocaine dependence in schizophrenia     plus cocaine dependence sufferers compared to a standard typical antipsychotic treatment     (perphenazine). The working hypothesis states that subjects in the aripiprazole treatment arm     of the study will give fewer cocaine positive urine specimens as compared to the perphenazine     control arm.   "
220451|NCT00730158|"     KD018 is an oral form of a spray dried aqueous extract composed of four main herbs, which     have been used in the Orient for nearly 2000 years for a variety of GI symptoms including     diarrhea and nausea/vomiting. Extensive pre-clinical research has been done with Chinese     herbal medicine, and studies have documented significant anticancer activity in combination     with various cytotoxic agents including Irinotecan, which is a semi-synthetic derivative of     the natural alkaloid camptothecin and belongs to the class of topoisomerase I inhibitors. The     proposed plan will investigate the mechanism and efficacy of Chinese herbal medicine as an     adjunct to chemotherapy in treatment of patients with metastatic colorectal cancer. Our     rationale for the therapeutic use of KD018 is its potential activity in reducing     chemotherapy-induced toxicity, especially diarrhea.   "
220452|NCT00730171|"     The objective of this study is to assess the long-term safety of linaclotide administered to     patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C)   "
220453|NCT00730184|"     The purpose of this study is to examine whether adding the basic salt potassium bicarbonate     to the diet will have a positive effect on how dietary protein affects your bone and muscle.   "
220454|NCT00730197|"     The objective of this study was to investigate the bioequivalence of nisoldipine     extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release     40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg     tablet) dose administration in healthy adult subjects under fasting conditions.   "
220455|NCT00730210|"     The aim of the study is to assess whether PTH (1-84) therapy posses advantages compared to     conventional treatment in patients with hypoparathyroidism on muscle function, quality of     life, calcium homeostasis, bone metabolism, and body composition.   "
220456|NCT00730223|"     To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug     levels and central nervous system side affects in people who take nevirapine or efavirenz.   "
220457|NCT00730236|"     The goal of this trial is to study the effects of AEGR-733 on LDL cholesterol, other lipids     as well as measures of safety over the long-term.   "
220458|NCT00730249|"     Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD,     compared with a placebo   "
220459|NCT00730262|"     The objective of this study is to assess the efficacy and safety of TLN-4601 used to treat     patients with Glioblastoma Multiforme(GBM) that recur/progress after receiving first line     systemic therapy post surgery/radiotherapy.   "
220461|NCT00730288|"     To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the     ChimeriVax™ dengue tetravalent vaccine      Primary Objectives:        -  To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine.        -  To describe the immune response against dengue before and after one injection of          ChimeriVax™ dengue tetravalent vaccine   "
220462|NCT00730301|"     The purpose of this study is to assess the efficacy of a new treatment algorithm for     bronchoscopic lung volume reduction (BLVR) in patients with emphysema based on the     information of emphysema heterogeneity, destruction score, and fissure analysis.   "
220463|NCT00730314|"     This is a clinical trial of bone marrow transplantation for patients with the diagnosis of a     genetic disease of blood cells that do not have an HLA-matched sibling donor. Genetic     diseases of blood cell include: Red blood cell defects e.g. hemoglobinopathies (sickle cell     disease and thalassemia), Blackfan-Diamond anemia and congenital or chronic hemolytic     anemias; White blood cells defects/immune deficiencies e.g. chronic granulomatous disease,     Wiskott-Aldrich syndrome,Osteopetrosis, Kostmann's syndrome (congenital neutropenia),     Hereditary Lymphohistiocytosis (HLH); Platelets defects e.g.Congenital amegakaryocytic     thrombocytopenia; Metabolic/storage disorders e.g. leukodystrophies,mucopolysaccharidoses as     Hurler disease;Stem cell defects e.g.reticular agenesis, among many other rare similar     conditions.      The study treatment plan uses a new transplant treatment regimen that aims to try to decrease     the acute toxicities and complications associated with the standard treatment plans and to     improve outcome      The blood stem cells will be derived from either unrelated donor or unrelated umbilical cord     blood.   "
220464|NCT00730327|"     Safety and effectiveness of the BIB® System in conjunction with a behavior modification     program compared to the behavior modification program alone for weight loss in obese     subjects.   "
220465|NCT00730340|"     This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae     closure compared to without closure of the operative wound.   "
220466|NCT00730353|"     Paclitaxel is known to be active as a single and combination agent in esophageal cancer, and     has also been demonstrated to have anti-angiogenic properties in weekly dosing regimens.     Sunitinib malate is an anti-angiogenic drug with the potential to improve responses when     combined with chemotherapy, as demonstrated with other regimens in similar settings. We     believe that the combination of paclitaxel and sunitinib malate offer great promise in the     treatment of advanced esophageal cancer.   "
220482|NCT00730561|"     Several pathophysiological theories have been proposed for the development of diabetic     chronic complications. In recent years, the use of stem cells (totipotential, hematopoietic     or endothelial lineages) has been reported as an adjunctive modality of treatment for     ischemia models in animals and humans. Nevertheless, there are no reports in the use of stem     cells for the treatment of human sensorimotor peripheral diabetic neuropathy. We performed     this study to evaluate the effect of autologous hematopoietic CD34+ cell transplantation on     nerve conduction velocity in patients with type 2 diabetes mellitus.   "
220483|NCT00730574|"     The purpose of this study is to determine the commonness of the C677T mutation in the MTHFR     gene in subjects with B12 deficiency. Also, we'd like to investigate the effect of B12     deficiency combined with the C677T mutation on endothelial function.   "
220484|NCT00730587|"     The InfantPod study is a cross-sectional study designed to determine how practical and     precise a body composition method is for measuring body fat and lean tissue in infants and     children ages 5 months to 3 years.   "
220485|NCT00730600|"     The purpose of this study is to explore the skeletal effect of Thai traditional massage by     examining the changes in biochemical markers of bone turnover immediately after the massage.   "
220467|NCT00730366|"     Malaria in pregnancy contributes substantially to maternal anaemia and low birth weight:     effective malaria control in pregnancy could avoid about 10,000 maternal and up to 200,000     infant deaths every year. Intermittent preventive treatment with the drug     sulfadoxine-pyrimethamine (IPTp-SP), administered at least twice during routine antenatal     clinics, is recommended by the World Health Organization for areas of moderate to high     malaria transmission, including Sub-Saharan Africa.      Studies carried out in Kenya and Malawi before 2004 had showed that two doses of IPTp-SP     significantly reduce maternal anaemia, placental malaria parasitaemia and low birth weight.     However, in countries where this strategy had been introduced as part of national policy, the     coverage of the target population has varied widely, with estimates of 33-93% for uptake of     one dose and 24-68% for two doses, and no country had reached the goal of 80% of pregnant     women receiving at least 2 doses of IPTp. New approaches designed to improve IPTp coverage     were therefore urgently needed.      This study was therefore set up in 2002, in order to evaluate the additional effect of a     targeted promotional campaign on antenatal clinics utilization and on coverage and uptake of     Intermittent preventive treatment with sulfadoxine-pyrimethamine in a rural health district     in Burkina Faso; and to investigate the effectiveness of intermittent preventive treatment     with the sulfadoxine-pyrimethamine compared with weekly chloroquine, in order to provide     additional evidence to the Burkinabé Ministry of Health for an impending policy change.   "
220468|NCT00730379|"     This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in     patients who have advanced cancer and to observe any anti-tumor activity in these patients.   "
220469|NCT00730392|"     The investigators hypothesized that the administration of Etanercept to children newly     diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study     is to evaluate the feasibility and safety of Etanercept administration to pediatric patients     recently diagnosed with type 1 DM.   "
220470|NCT00730405|"     Phase 2 study to examine how the study drug works and its side effects in subjects with     toenail fungus.   "
220471|NCT00730418|"     In this study, we investigate the changes of the expression of alpha adrenergic receptor in     the prostate tissue during 2-yr medication period in the man with benign prostatic     hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin     (4mg, 8mg)   "
220472|NCT00730431|"     The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of     IDX184 in humans. No formal hypotheses are to be tested in this study.   "
222082|NCT00751764|"     The purpose of this study is to evaluate the extent of moxidectin transfer into the breast     milk of lactating women and to provide the initial pharmacokinetic and safety profile of     moxidectin in lactating women.   "
220473|NCT00730444|"     GE Healthcare has recently submitted a New Drug Application (NDA) for Iobenguane I 123     Injection ([123I]mIBG (AdreView)) as a diagnostic nuclear imaging agent for the detection of     primary or metastatic neuroblastoma and pheochromocytoma. The present protocol establishes an     Expanded Access program to provide AdreView to pediatric medical centers and hospitals that     treat neuroblastoma patients. AdreView will be provided for use in diagnostic assessment of     patients with known or suspected neuroblastoma for whom there is an appropriate clinical     indication for [123I]mIBG imaging.   "
220474|NCT00730457|"     Is VAX125 safe at doses ranging from 0.1 to 8 ug when delivered i.m. in a single dose regimen     Is VAX125 able to induce a post-vaccination serum HAI antibody response in healthy adults     against the influenza A virus H1 HA.   "
220475|NCT00730470|"     This is a Phase 1 clinical study to investigate the safety, pharmacokinetics, and     pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3     receptor, in patients with advanced solid tumors. Eligible patients will have disease that is     refractory or resistant to standard treatments or for which no standard therapy exists. The     study will be conducted in two parts; a dose escalation (Part 1) and a dose expansion (Part     2). The hypothesis for this study is that U3-1287 (AMG888) will be safe and well tolerated in     patients with advanced solid tumors and will show initial evidence of anti-tumor activity.   "
220476|NCT00730483|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Infusing doxorubicin beads into the liver, and blocking blood flow to the tumor, may keep     doxorubicin near the tumor and kill more tumor cells.      PURPOSE: This clinical trial is studying the side effects of doxorubicin beads and to see how     well they work in treating patients with unresectable liver metastases from neuroendocrine     tumors.   "
220477|NCT00730496|"     Forty-five infertile women undergoing in vitro fertilization treatment were managed by     uterine cavity injection of day 2 embryo culture supernatant before day 3 embryo transfer. No     statistically significant differences were found in implantation and pregnancy rates when     compared with control group.   "
220478|NCT00730509|"     The purpose of this study is to determine whether 5 - methyltetrahydrofolate and vitamin B12     supplementation can ameliorate cell plasma membrane features in pediatric patients with     cystic fibrosis   "
220479|NCT00730522|"     The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated     subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of     the study's Treatment Phase (Weeks 11 and 12).   "
220480|NCT00730535|"     This is a Phase IV, prospective, randomized, multi-center study to find risk factors of OAB     symptoms relapse in patients who showed therapeutic benefits after 1, 3, or 6 months of     treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.      Patients who have OAB symptoms for 6 or more than 6 months and who show successful treatment     response to 1 month of treatment with Tolterodine SR 4mg will be enrolled and randomized to     1, 3 or 6 months of treatment group. After completion of the treatment, subjects will be     evaluated for changes in OAB symptoms and retreatment rate will be assessed.   "
220481|NCT00730548|"     This pilot study is to prospectively evaluate the benefit of clinicians being able to access     ICD device information in a timelier manner and treat fluid overload with a pre-defined     pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in     Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic     OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician     (standard arm).   "
220519|NCT00731042|"     Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy     volunteers.   "
223260|NCT00773058|"     The purpose of this study is to see if stress doses of hydrocortisone improve early outcome     in patients who are in early stage of ARDS and with relative adrenal insufficiency.   "
220486|NCT00730613|"     RATIONALE: Cellular adoptive immunotherapy may stimulate the immune system in different ways     and stop cancer cells from growing.      PURPOSE: This clinical trial is studying the side effects of cellular adoptive immunotherapy     using genetically modified T-lymphocytes and to see how well it works in treating patients     with recurrent or refractory high-grade malignant glioma.   "
220487|NCT00730626|"     The purpose of this study is to determine the dose-response effect of a yogurt containing a     combination of bifidobacterium Lactis (BB-12) and Lactobacillus Acidophilus (LA-5) and green     tea extract on markers of the immune system and gut health in healthy subjects. We     hypothesize that the response of the immune function will be dose-dependent of the probiotics     found in the fermented yogurt.   "
220488|NCT00730639|"     The purpose of this study is to determine the safety and effectiveness of MDX-1106 in     patients with certain types of cancer. Another purpose is to determine how MDX-1106 is     absorbed and distributed within the body, and how it's eventually eliminated.   "
220489|NCT00730652|"     To determine if MDX-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle     cell lymphoma.   "
220490|NCT00730665|"     To understand the dose-response characteristics of PF-00885706 for efficacy in terms of     symptomatic relief when used as add-on treatment to esomeprazole 20mg (standard proton pump     inhibitor [PPI] treatment), in subjects with gastro-esophageal reflux (GERD) who have     inadequate relief with PPIs.   "
220491|NCT00730678|"     To investigate whether genetic polymorphisms in genes encoding proteins involved in the     metabolism or effects of drugs or environmental agents influence the disposition or effects     of these xenobiotic substrates. To investigate the nature of heritability and the genetic     basis of pharmacogenetic traits by studying family members of individuals with specific     genotypes.   "
220492|NCT00730691|"     The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily     (QD), in adults with generalized anxiety disorder.   "
220540|NCT00731315|"     Our study aims to test the utility of computer-assisted treatment for uncomplicated,     recurrent urinary tract infections (UTIs) for women receiving care in safety net health care     facilities. As of November 2009, we are also testing the utility of computer-assisted     treatment for certain types of complicated cystitis (i.e. women with voiding symptoms and one     of the following complicating symptoms: fever, flank pain, or symptoms greater than 7 days).   "
220493|NCT00730704|"     Worldwide cervical cancer remains a major cause mortality among women. It is estimated that     each year over 490,000 women are diagnosed with cervical cancer and more than 270,000 die     from the disease. While the implementation of widespread screening programs has reduced the     burden of cervical cancer, a large percentage of the population still remains unscreened or     is underscreened. It is now recognized that human papillomavirus (HPV) is a necessary     precursor for the development of cervical cancer. The first vaccine to prevent HPV was     recently approved by the Food and Drug Administration and is now available at doctors     offices. Despite the availability of a safe and effective means for the prevention of     cervical cancer, widespread implementation of vaccination has been extremely difficult.     Several potential issues have limited the development of widespread HPV vaccination programs,     including cultural and religious beliefs, and limitations in the practicality of     administering the vaccine. The overall goals of our work are to improve access to preventive     strategies for cervical cancer. In this proposal we will examine the strategy of HPV     vaccination for women who have just given birth. We believe that HPV vaccination of these     women will be associated with a high level of patient satisfaction and acceptance. If     successful, this strategy could play a major role in advancing the acceptance and     implementation of HPV vaccination in the United States.   "
220494|NCT00730717|"     The purpose of this study is to determine the safety and efficacy of Humira in the treatment     of pyoderma gangrenosum.   "
220495|NCT00730730|"     The purpose of this study is to show if a new delivery system with a modified stent is safe     in treating occluded iliac arteries in patients with peripheral vascular disease. The     modified Complete SE delivery system is hypothesized to assist physicians with more accurate     stent placement reducing the likelihood of stent 'jumping' seen with the use of many     self-expanding stent systems.   "
220496|NCT00730743|"     This study aims to evaluate whether applying inflow vascular occlusion in modern liver     resection is associated with better clinical outcome.      Eligible patients are randomly assigned to the two surgical techniques: with or without the     application of inflow vascular occlusion.      Patients outcome including liver function recovery, operative time and blood loss are     compared.   "
220497|NCT00730756|"     The purpose of this pilot study is to compare the effects (effectiveness and safety)of an     intranasal corticosteroid (fluticasone furoate nasal spray [FFNS]) with a placebo nasal spray     for the treatment of irritant (non-allergic) rhinitis.   "
220498|NCT00730769|"     The objectives of this study were:        1. To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV          infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days          of treatment.        2. To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with          respect to ganciclovir given intravenously (i.v.).        3. Evaluate the security of this treatment with valganciclovir.   "
220499|NCT00730782|"     The objective of this study was to evaluate the safety of a candidate malaria vaccine     (PfAMA-1) at 3 doses given at monthly intervals of 2 different dosages of AMA-1 (10 μg or 50     μg ) adjuvanted either with alum hydroxide or AS02A or Montanide ISA 720 in healthy adults     not previously exposed to the parasite Plasmodium falciparum.   "
220500|NCT00730795|"     This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals'     candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.   "
220501|NCT00730808|"     The aim of this pilot study is to investigate effectiveness, tolerability and safety of an     oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low     anterior resection.   "
220502|NCT00730821|"     The primary objective of this trial is to determine the MTD of the combination of BIBW     2992/BIBF 1120 therapy administered concomitantly in a 28-day cycle schedule.      Secondary objectives are the collection of antitumor efficacy data, the determination of     pharmacokinetic parameters of BIBF 1120 and BIBW 2992, and if data allow the determination of     the pharmacokinetic influence of BIBW 2992 on BIBF 1120 and vice versa.   "
220520|NCT00731055|"     The investigators hypothesize that varenicline will dose dependently attenuate the subjective     effects of cigarettes after a period of abstinence. Also, treatment with varenicline will     dose dependently weaken the severity of nicotine withdrawal symptoms. Thirdly, we hypothesize     that treatment with varenicline will dose dependently decrease cigarette self-administration     in the model proposed.   "
220503|NCT00730834|"     Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with     clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared     Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion     criteria and they are also required to pay for the all costs of the treatment. Subjects will     be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient     questionnaires (subjects must have access to a computer and internet in order to complete on     line questionnaires).   "
220504|NCT00730847|"     This study will collect clinical data (safety and reactogenicity) of GlaxoSmithKline     Biologicals' human papillomavirus (HPV) vaccine in the local target population as per the     Bureau of Food and Drugs Directive of Philippines.   "
220505|NCT00730860|"     A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by     RFA associated with postoperative TACE.   "
220506|NCT00730873|"     Non-alcoholic fatty liver disease is associated with obstructive sleep apnea. Abnormalities     in liver enzymes can improve following continuous positive airway pressure in patients with     obstructive sleep apnea. Computerized tomography can be used to quantify fatty liver changes.     We hypothesize that continuous positive airway pressure can reduce morphologic fatty liver     changes in patients with obstructive sleep apnea and non-alcoholic fatty liver, an that this     reduction can be evident using computerized tomography   "
220541|NCT00731328|"     RATIONALE: Giving low doses of chemotherapy and antithymocyte globulin before a donor stem     cell transplant helps stop the growth of abnormal cells. It may also stop the patient's     immune system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune cells and help destroy any remaining abnormal cells (graft-versus-tumor     effect).      PURPOSE: This phase II trial is studying how well a donor stem cell transplant works after     busulfan, fludarabine, methylprednisolone, and antithymocyte globulin in treating patients     with bone marrow failure syndrome.   "
220507|NCT00730886|"     The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000     system for enhancement of fertility in women with non-hysteroscopically resectable uterine     fibroids, who are diagnosed with unexplained infertility.      Uterine fibroids are fairly common in women of child-bearing age. An evidence based review     supported removing fibroids that distort the uterine cavity to increase pregnancy rates and     decrease the rates of miscarriage. Some fibroids can be removed hysteroscopically which is     minimally invasive, with low morbidity. However, removal of fibroids within the uterine wall     require more invasive surgical procedures (e.g., myomectomy), with increasing morbidity risks     including, but not limited to, infection, blood loss and postoperative uterine adhesions.      ExAblate is approved by FDA for the treatment of uterine fibroids; however, its use in     patients seeking pregnancy is considered experimental. Accumulated evidence suggests there     are no significant complications from the procedure in women seeking pregnancy as with     existing fibroid therapies; however, these data are based on a small number of patients. This     study will evaluate fertility enhancement following ExAblate treatment or myomectomy, in     women with unexplained infertility and who have non-hysteroscopically resectable uterine     fibroids.   "
220508|NCT00730899|"     The purpose of this study is to determine whether polymorphisms in G protein subunits, namely     Galphas and Galphaq, are associated with altered cardiac performance in heart failure     patients.   "
220509|NCT00730912|"     This is a post marketing study to confirm the appropriate dose of loratadine in children by     obtaining drug concentration data at multiple time points per child and adult patient, after     the patient receives repeated administrations of the approved dose of loratadine.   "
220510|NCT00730925|"     The primary objective of this open-label, single arm Phase II trial is to explore the     efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the     RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour     activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with     mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no     EGFR mutations.   "
220511|NCT00730938|"     The study investigates whether placing an antibiotic inside the eye at the end of cataract     surgery in children will reduce the amount of fibrin formation (fibrin formation can block     the pupil and reduce vision). We hypothesize that the fibrin is caused by a low-level     infection and could be prevented by the antibiotic.   "
220512|NCT00730951|"     While the use of herbals is increasing considerably, their efficacy and safety in the humans     remains largely unknown. This surge in demand prompts a call for its evaluation. Preliminary     data demonstrates that KRG can affect vascular function and our research group has previously     shown that Korean Red Ginseng (KRG) can lower blood pressure (BP) in hypertensive     individuals. However, it is unknown which dose is the most effective in producing a desired     effect. To address this issue, we will test escalating doses of a single Korean red ginseng     batch of 0.5g, 1g 3g and 6g on BP in patients with hypertension to determine the most     efficacious dose. The most promising dose will be extracted and will advance to next level to     be tested again on BP control. The findings of the study may result in better ginseng     standardization.   "
220513|NCT00730964|"     This prospective surveillance trial will gather safety information for Optison when it is     used in routine practice.   "
220514|NCT00730977|"     A novel dry powder inhaler device will be used to administer mannitol to healthy subjects and     subjects with bronchiectasis in single doses higher than previously given.The main objective     is to assess tolerability of these doses using the new device.   "
220515|NCT00730990|"     The primary purpose of this study is to assess central receptor occupancy of PF 03654746 at     the H3 receptor after a single oral dose of PF 03654746.   "
220516|NCT00731003|"     Serotonin, 5-hydroxytryptamin (5-HT), plays an important role in regulating the     gastrointestinal functions. In this study we will modulate the serotonin system with acute     tryptophan depletion (ATD) and administration of 5-hydroxytryptophan (5-HTP). ATD is based on     ingestion of an amino acid drink devoid of the precursor of serotonin and hence caused a     decreased serotonin level. 5-hydroxy-tryptophan is the direct precursor of serotonin and its     administration, an increased serotonin level is expected. During these interventions, gut     permeability and visceral sensitivity will be measured in healthy individuals and patients     with irritable bowel syndrome, which is characterized by altered permeability and visceral     hypersensitivity.   "
220517|NCT00731016|"     We suggest treating the Hutchinson-Gilford Progeria Syndrome by two molecules (zoledronic     acid and pravastatin).The therapeutic approach which we propose has for objectives to reduce,     to prevent or to delay the gravest infringements of the disease, to prolong the life of the     children, and in a more general way, aim at improving their living conditions.   "
220518|NCT00731029|"     This is a comparative vaccination study of the reactogenicity and immunogenicity of a     thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of     Influsplit SSW® 2002/2003 in individuals over 18 years.   "
220524|NCT00731107|"     The method most commonly used to gain entry to the abdomen in laparoscopic surgery (minimally     invasive surgery) amongst gynecologists is the Veress Needle. This needle is inserted,     usually near the belly button, before adding gas to the abdomen. With a pressurised abdomen a     sharp trocar is then inserted to hold the operating telescope.      The XCEL bladeless trocar is another method of inserting the operating telescope whereby you     don't need to first introduce gas before the trocar. This trocar is widely used in     laparoscopic surgery but it is uncommon to the field of gynecology.      This study will compare the two methods with regard to:        1. Time taken to enter the abdomen        2. The number of attempts taken to enter the abdomen        3. The impact of the time taken to enter compared to the whole operating time        4. The happiness that the surgeon has entered the abdomen before adding gas, on a scale of          1 to 5.      Patients will be recruited into the trial through the Monash Medical Centre Gynecology     department and the Mercy Hospital for Women Gynecology department. Patients that are having     laparoscopic surgery and would usually have a Veress Needle entry are suitable for this     trial. A patient information sheet will be provided and written consent will then be     obtained. Patients who give written consent will be randomised into one of two arms of the     trial, either the control (Veress Needle) or the XCEL bladeless trocar arm.      Information will be entered on a proforma by a researcher for each patient during their     operation. All patient information will be strictly confidential and only be available to     researchers directly involved in the study.      Surgeons operating as part of the project are the consultants and fellow of the gynecology     department of Monash Medical Centre and Mercy Hospital for Women and are competent in both     techniques.      200 women will be recruited over a one year period and the data will then be analysed with     the help of a statistician.   "
220525|NCT00731120|"     The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg     vortioxetine, once daily (QD), in adults with generalized anxiety disorder.   "
222885|NCT00770341|"     The study investigates the efficacy and safety of MK-3009 in participants with skin     infections, septicemia and right-sided infective endocarditis (RIE) caused by     methicillin-resistant Staphylococcus aureus (MRSA).   "
220526|NCT00731133|"     This 8 week, open-label pilot clinical trial will examine the safety and tolerability of     disulfiram at 250 mg/day in up to fifteen methamphetamine dependent individuals. After     undergoing screening procedures (approximately one week), eligible subjects will enter the     study proper attend clinic every weekday during week 1 of the trial in order to receive the     disulfiram under observation and complete assessments. Then subjects will receive weekly     blister packs of medication and attend clinic thrice weekly during weeks 2-6. During weeks     7-8, subjects no longer take disulfiram, are followed for two weeks, then referred to     treatment elsewhere, if desired. Urine samples will be obtained and a disulfiram side-effects     checklist will be completed thrice-weekly. Self-reported drug use, craving and mood ratings     will be completed weekly. All subjects undergo cognitive behavioral therapy. Adjunctive     contingency management procedures will be utilized to enhance retention. The primary outcomes     of interest include retention, side-effects, and drug use. Our hypothesis is that disulfiram     will be well tolerated in this population.   "
220527|NCT00731146|"     Interscalene brachial plexus block (ISBPB) is a common nerve block given to patients who are     undergoing shoulder surgery. This block has a low, but still significant, rate of     complications. Reducing the volume of local anesthetic given during the block may allow some     of these complications to be avoided. Participants will be randomly assigned to a group to     undergo ISBPB under ultrasound or nerve stimulator guidance. Each group will initially     receive 10mL of local anesthetic. The volume used for each subsequent patient depends upon     the success or failure of the previous patient's block - a failure will cause the volume     given to increase by 2.5mL, while a success will cause the volume to decrease by the same     amount. We hypothesize that the minimum effective anesthetic volume in 50% of patients will     be significantly lower in the ultrasound guided group than in the nerve stimulator group. We     further hypothesize that this lower volume will lead to a decreased rate of complications.   "
220528|NCT00731159|"     Our aim is to evaluate the potential of a new laboratory method that measure sperm     capacitation to predict fertilization of oocytes in patients that undergo IVF treatments   "
220529|NCT00731172|"     phase 2 study. Target disease: Crohn's disease.      Rational and relevance to IBD patients:      Copaxone is known for its high safety profile and for acting as an effective immunomodulatory     agent for the treatment of MS. . In experimental models of IBD, a beneficial effect of     Copaxone was demonstrated where significant amelioration of macroscopic colonic damage,     preservation of the microscopic colonic structure, reduced weight loss, and improved     long-term survival in treated compared with untreated mice was demonstrated. In addition,     Copaxone suppressed the proliferation of local mesenteric lymphocytes to syngeneic colon     extract, significantly reduced the overall secretion of TNF-α and induced the secretion of     transforming growth factor (TGF)-β. The ability of Copaxone to effectively modulate the     clinical manifestations and the detrimental immune response involved in experimental colitis,     together with its high safety profile support its potential effect as a new treatment for CD.      Patients: patients with moderately active Crohn's disease as indicated by a CDAI 220 - 450,     whose diagnosis was done more than 3 months before enrollment.      Study objectives: to test the efficacy and safety of Copaxone in CD patients.      Study design: This will be a single center, randomized, double blind placebo controlled phase     2 study.      Subjects will be assessed for study eligibility 1 to 2 weeks prior to baseline Eligible     patients will be enrolled into the study after signing an informed consent form and allocated     in a 1.5:1 ratio to receive either Copaxone or placebo. A total of 50 patients will be     recruited.      Subcutaneous injections (Copaxone or Placebo) will be administered daily through week 12.     Patient assessment of safety and efficacy will be made at weeks 0,4,8,12 and 16.      At week 12 non-responders would be offered an open label arm with daily Copaxone 20mg for the     next 12 weeks   "
220530|NCT00731185|"     This study was conducted to evaluate the effectiveness of mometasone nasal spray in     preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal     polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS)     on visit 2. Mometasone nasal spray or placebo was started about 2 weeks after surgery and     continued for up to 24 weeks or until relapse.   "
220531|NCT00731198|"     The aim of the present study was to evaluate the use of drotaverine hydrochloride versus     hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.   "
220532|NCT00731211|"     This is a Phase II, non-randomized, open-label, single-arm study in patients with metastatic     renal cell carcinoma who have received one prior targeted therapy with either sunitinib or     bevacizumab. The planned enrollment for this study is 60 patients.   "
220533|NCT00731224|"     This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of     rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26)     initiating therapy for the first time with a cholinesterase inhibitor, and in patients who     were unresponsive to previous cholinesterase inhibitor treatment in a community setting.   "
220534|NCT00731237|"     This trial is to assess physician-determined XIENCE V® EECSS acute performance,     deliverability and resource utilization in the catheterization lab during commercial use by     various physicians with a range of coronary stenting experience   "
220535|NCT00731250|"     This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by     capsaicin challenge   "
220536|NCT00731263|"     The purpose of the study is to assess the safety, tolerability and pharmacokinetics of     AZD8055 and determine the maximum tolerated dose to take into phase II trials.   "
221322|NCT00749957|"     The purpose of the study is to evaluate the safety and efficacy of an adeno-associated virus     vector expressing RPE65 in patients with Leber congenital amaurosis caused by mutations in     the RPE65 gene.      Funding Source - FDA OOPD   "
220537|NCT00731276|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan in     treating Asian patients with solid tumors.   "
220538|NCT00731289|"     The aim of this study was to analyse the difference of the functional and clinical outcome     after intraarticular treatment of patients with osteoarthritis of the knee with a single     injection of hyaluronan (HA) or Triamcinolone (TA) with respect to the quality of life during     the study period.   "
220539|NCT00731302|"     This study examine whether patients with lupus respond to aspirin , and if not, if that is     related to inflammation. We examine the ability of aspirin to inhibit the production of     thromboxane in patients with lupus and controls and see if aspirin insensitive thromboxane     production is inhibited by meloxicam.   "
220542|NCT00731341|"     The purpose of the current study is to evaluate the technical success, safety and procedure     feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women     who do not desire further pregnancies using Galil Medical's 17-gauge 400mm Argon-based     cryoablation needles   "
220543|NCT00731354|"     This study is being done to compare two commonly available types of body contouring,     VASER-Assisted Lipoplasty (VAL) and Suction-Assisted Lipoplasty (SAL), and to decide if one     procedure is preferred by patients and/or surgeons over the other. Participants will have VAL     on one side of their body and SAL on the opposite side.   "
220544|NCT00731367|"     This phase IIIb, randomized, comparative, multi-center study is designed to evaluate two     AQUACEL Ag protocols of care for the management of split-thickness donor sites. Both     protocols of care will utilize AQUACEL Ag as the primary dressing. As per the randomization     assignment, one protocol of care will have the AQUACEL Ag initially covered with a gauze     dressing to create an adherent state and in the other protocol of care the AQUACEL Ag will be     covered with a transparent film to maintain a gelled state.      The primary objective of the study will be to quantify the proportion of subjects healed at     14 days. Secondary objectives will include: time to healing, degree of pain at dressing     change and while wearing the dressing, simplicity of use, resources used in treatment and     safety. Approximately 68 subjects will be enrolled from 10 centers from within the US and     Canada.   "
220545|NCT00731380|"     The purpose of this study is to determine the highest dose of a ABI-007 that can be given     with cisplatin and 5-fluorouracil without causing intolerable side effects in patients with     advanced head and neck cancer.   "
220546|NCT00731393|"     The aim of the present study is to assess the reactogenicity and immunogenicity of a     thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the     standard formulation of Influsplit SSW® 2003/2004.   "
220547|NCT00731419|"     Background:      When considering any malignancy with limited life expectancy, palliation and quality of life     are paramount. Owing to the limited centres offering ERCP and endoscopic palliation in the     South African state sector, patients often travel vast distances and spend large amounts of     time away from family and social support structures, severely impairing their quality of     life. Stent occlusion with resultant readmission to an ERCP accredited centre obviously     compounds this problem.      The hypothesis we propose to test is whether metal stents as a primary procedure result in     better patency rates, are more cost effective and improve quality of life than plastic     stents. We propose to do this by means of a randomised trial determining the best method of     palliation for inoperable distal common bile duct malignancies in the South African context.      Primary end-point Assessing the cost of metal versus plastic stenting in inoperable malignant     distal common bile duct strictures in patients with expected survival of 3 months or more as     palliation of symptomatic obstructive jaundice. Cost to be assessed in terms of hardware,     hospital stay and readmissions for stent occlusion(patency) and complications Secondary     end-point Assessing quality of life using a validated scoring system(EORTC QLQ 30) in     patients receiving a metal or plastic biliary stent as definitive means of palliation of     malignant obstructive jaundice      Hypothesis to be tested Metal stents are superior to plastic stents in terms of patency,     resulting in more cost effective palliation of inoperable malignant jaundice and better     quality of life due to fewer stent occlusions/episodes of cholangitis.   "
220548|NCT00731432|"     Diabetes increases the incidence and severity of periodontal inflammation and disease, and     periodontal disease causes an increase in the severity of diabetes by worsening glycemic     control and increasing insulin resistance.The Transmucosal Herbal Periodontal Patch (THPP) is     a transmucosal patch containing an herbal compound that has an anti-inflammatory effect on     gingival tissue.The primary objective of this study is to determine the efficacy of the     Transmucosal Herbal Periodontal Patch (THPP) compared with placebo patch (PP) in reducing     gingival inflammation at the site of placement in diabetic patients. We also aim to determine     if the THPP decreases gingival inflammation throughout the mouth and the safety of THPP     compared with placebo patch when applied to the mucosa in the treatment of gingival     inflammation in diabetic patients.   "
220549|NCT00731445|"     This phase I/II is studying the side effect and best dose of Z-208 for patients with advanced     hepatocellular carcinoma   "
220979|NCT00747279|"     The purpose of this prospective randomized controlled trial was to compare intensive insulin     therapy with a carbohydrate restrictive strategy in patients with acute ischemic stroke     evaluating the outcome through the Glasgow Outcome Scale Extended, hospital mortality and     NIHSS during the ICU stay.   "
220550|NCT00731458|"     Ocular Coherence Tomography (OCT) is a non-invasive ophthalmologic test that uses reflected,     unheated, non-concentrated visible light in order to scan and provide a 2-dimensional     topographic analysis of the retina and optic nerve. It has wide diagnostic utility especially     in patients with clinically significant macular edema, glaucoma, and other retinal eye     diseases. At the University of Chicago, we have utilized the Stratus brand OCT (Carl Zeiss     Inc) for the past 5 years. Recently we have acquired a beta version of the company's new     model, the Cirrus HD-OCT (Carl Zeiss Inc.) which features improved resolution, shorter     scanning time and a more user-friendly interface. The purpose of this study is to compare     findings between the two models in patients with different common and uncommon eye diseases,     including diabetic macular edema, glaucoma and age-related macular degeneration. We     hypothesis that the Cirrus OCT is able to accurately quantify eye pathology compared to     Stratus OCT.   "
220551|NCT00731471|"     This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are     infected with HIV. It is designed to study the safety and immunogenicity of the vaccine.   "
220552|NCT00731484|"     The objective of this study is to validate the performance of the OcuSense TearLab™     osmolarity test when performed in physician office laboratories (POL) by health care     professionals using human tear fluid collected from volunteer subjects and contrived tear     samples.   "
220562|NCT00737295|"     This is a prospective, non-randomized study of 50 people with suspected biliary dyskinesia.     The purpose of this study is to investigate if it is possible to use ultrasound to make a     diagnosis of a condition called biliary dyskinesia. The investigators null hypothesis is that     there will be no statistical difference between the proposed experimental test (Ultrasound)     and the HIDA scan (a nuclear medicine hepatobiliary system scan) in the diagnosis of biliary     dyskinesia.   "
220563|NCT00737308|"     The objectives of this study are to determine the clinical performance of zirconia-based     dental prostheses and their related properties.   "
223495|NCT00776360|"     The investigators are going to examine whether oxytocin has a prokinetic effect on gastric     emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with     sodium chloride infusion.   "
220553|NCT00731497|"     The importance of waterborne gastrointestinal illness throughout the developing world, the     existence of a cheap and effective intervention (SODIS), the concurrent limited dissemination     program for SODIS, the need for a controlled evaluation of the effectiveness of SODIS under     actual field conditions, and the experience of our tri-national collaborative research team     in successfully conducting large scale drinking water intervention and observational studies     in both the United States and the developing world encourage us to propose the following     randomized controlled trial in which our specific aims are to:        -  Evaluate the hypothesis that SODIS reduces the incidence of gastrointestinal illness in          660 children under the age of five years in rural Bolivia that are randomly selected          from 22 villages ;        -  Define, through an extensive microbiologic testing component, the baseline rates of          pathogen-specific diarrheal illnesses and the pathogens responsible for the differences          in diarrheal illness between active and control groups;        -  Document the actual use and acceptance of SODIS by participants in the study;        -  Assess the cost-effectiveness of SODIS and the social and economic impact of SODIS at          household level;        -  Examine through mathematical disease modelling the effects of the presence of multiple          transmission pathways within a village on the preventable fraction estimate due to the          introduction of SODIS.   "
220554|NCT00731510|"     During a multi−week expedition to the Himalaya, we aim to investigate i) whether dietary     supplementation with carbohydrate drinks and gels can improve physical performance; and ii)     the underlying mechanisms for any observed changes in performance.      We hypothesise that i) carbohydrate supplementation will improve physical performance; and     ii) the underlying mechanism of this improvement in performance will include maintenance of     body glycogen (sugar) stores, prevention of dehydration and decrease in the incidence of     acute mountain sickness.   "
220555|NCT00731523|"     The purpose of this study is to compare the pharmacokinetics of FTY720 and its metabolites in     patients with severe renal insufficiency and in matched, healthy volunteers. This study will     allow a better understanding of the effects of renal insufficiency on the disposition of     FTY720.   "
220556|NCT00731536|"     The purpose of this study is to examine reports of the cancer called hepatosplenic T-cell     lymphoma (HSTCL) in the Dutch National Database of Pathology (Pathologisch-Anatomisch     Landelijk Geautomatiseerd Archief or PALGA) during the years 1995 to 2008.   "
220557|NCT00731549|"     To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance     treatment in patients with schizophrenia.   "
220558|NCT00731562|"     1. To estimate the absorption of a single oral dose of a controlled release varenicline          tablet under fed and fasted conditions.        2. To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a          varenicline controlled release tablet under fed and fasted conditions.   "
220559|NCT00731575|"     The purpose of this study is to study prospectively the early clinical and immunological     events in children susceptible to rhinovirus induced early wheezing (i.e., recently found     highest risk factor for recurrent wheezing/asthma) and the efficacy of systemic     corticosteroid to modify these events.      Up to 50% of children suffer from acute wheezing before school-age. The prevalence of     childhood asthma is 5-7%. Although pediatric asthma is mainly allergic, the exacerbations are     associated with respiratory viral infections in 95% of cases. The means to predict asthma     from environmental factors have been limited mainly to sensitization to aeroallergens (3-fold     risk), which start to develop usually at 2-3 years of age. VINKU 1-study (orig. VINKU-study)     discovered simultaneously with two other groups, that early wheezing associated with     rhinovirus, the common cold virus, is the strongest predictor of recurrent wheezing/asthma     (up to 10-fold risky). Noteworthily, viral infections work as risk markers already during     infancy, a lot earlier than the sensitization to aeroallergens. The investigators also found     retrospectively that early wheezers affected by rhinovirus responded to 3 day course of oral     prednisolone (inexpensive and widely available treatment): recurrent wheezing decreased by     50% during following 12 months and the difference appeared to continue. VINKU 5V-study is     currently investigating the clinical history, prevalence of asthma and airway hyperreactivity     of these same children at school-age. The mechanism of rhinovirus associated risk or why they     respond to prednisolone are largely unknown. However, the susceptibility to rhinovirus     infections is associated with atopy and therefore it is possible these children may have     impaired anti-inflammatory (Treg) responses and more likely to wheeze with any     pro-inflammatory response (Th1 or Th2). Moreover, they may not effectively clear viruses,     because they can not limit rhinovirus to nose and it spreads to lower airways and causes     wheezing. VINKU 2-study will prospectively investigate the immunological events in young     first-time wheezers affected by rhinovirus, and prospectively study the clinical efficacy of     systemic corticosteroid in them. Most likely these children will benefit from the drug in     terms of less recurrent wheezing, the investigators will also explore immunological effects     of the drug and their link to clinical efficacy. The results are expected to give basis for     the prevention of asthma and for the development of new treatment strategies and they can be     directly applied to clinical medicine.   "
220575|NCT00737464|"     This single arm study will evaluate the maintenance of hemoglobin levels, safety and     tolerability of once-monthly intravenous administration of Mircera in dialysis patients with     chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms)     every four weeks depending on the previous dose of epoetin alfa administered in the week     preceding first study drug administration. Patients will be treated for 12 weeks with follow     up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12     months, and the target sample size is 100-500 individuals.   "
221054|NCT00738608|"     The aim of this study is to demonstrate that compared to placebo the preoperative     administration of a single dose of 120 mg etoricoxib can provide adequate pain relief in the     postoperative phase while reducing the need for systemic opioids. The primary endpoint is the     decrease of systemic opioid use.   "
220560|NCT00731588|"     OUR OVERALL HYPOTHESIS is that post-transfusion survival of allogeneic and autologous RBCs     can be accurately quantified in anemic human infants using biotin-labeled RBCs combined with     mathematical modeling that adjusts for confounding factors commonly encountered in neonates.     These confounding factors include 1) dilution of labeled RBC as a result of growth stimulated     erythropoiesis, anemia stimulated erythropoiesis, and blood transfusion; 2) loss of labeled     RBC due to laboratory phlebotomy; and 3) variable RBC life spans resulting from RBCs having     been produced at different developmental periods and under varying rates of erythropoiesis.     In contrast to infants, adjustment for these factors is not necessary in healthy adults under     conditions of steady state erythropoiesis. Instead in adults, RBC survival is typified by a     linear decline in concentration of labeled RBCs over time. When this line is extrapolated to     zero concentration, the intercept with the time axis represents the mean potential lifespan     (MPL) of RBCs. (<7 d) and stored (>21 d) allogeneic adult RBCs transfused in the same infant.   "
220561|NCT00737282|"     The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four     months each) will be evaluated.   "
220564|NCT00737321|"     This pilot study is designed to assess the impact of ischemia/ diminished wound     vascularization and stress on wound healing by comparing patterns of gene expression in     specific cell types critical to wound healing biology, e.g. macrophages or endothelial cells.   "
220565|NCT00737334|"     A highly desired result during carotid endarterectomy (CEA) is the ability to predict and     warn the surgeon if the brain is at risk of damage during the period of time that the carotid     artery is cross-clamped for surgical repair of the vessel narrowing. A number of approaches     for cerebral monitoring have been developed, including EEG, cerebral oximetry, and     measurement of arterial to jugular venous concentration differences of oxygen, glucose or     lactate. This study will utilize and compare multiple monitoring approaches for detecting     when and if the brain is at risk of injury during CEA. As such, this robust approach to     monitoring may permit a more prompt intervention to prevent or limit damage should cerebral     ischemia occur. In this study we will compare a processed EEG monitor -- the EEGo, which uses     nonlinear analysis to a bispectral (BIS) index monitor, and to the FORE-SIGHT cerebral     oximeter to assess the ability of each to identify cerebral ischemia should it occur with     carotid artery cross-clamping during CEA. These monitors will be correlated with arterial to     jugular venous lactate concentration difference, which has recently been shown to be a     sensitive indicator of hemispheric ischemia during CEA.   "
220566|NCT00737347|"     The purpose of the study is to investigate the effectiveness of three lifestyle treatment     programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain     and to measure the composition of the change in body weight.   "
220567|NCT00737360|"     The purpose of this study is to determine whether TAS-106 is effective to patients with     recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.   "
220568|NCT00737373|"     In this trial, FLOT will be evaluated as therapy option for elderly patients (>65 years) with     advanced gastric cancer in comparison to the well established FLO scheme. The hypothesis is     that FLOT is more effective than FLO in elderly patients with acceptable side effects.   "
220569|NCT00737386|"     The objective of the project is to study the pathogenesis of Leishmania tropica infection in     a focus of infection, to learn about relationship of infection in humans with ecological     factors such as infection in hyraxes reservoir hosts and vector sandflies   "
220570|NCT00737399|"     Anxiety and depression have been found to be significant co-occurring conditions in cancer     patients. This study examines these and other psychological conditions in patients diagnosed     with cholangiocarcinoma, a rare cancer of the bile duct, with an average survival time of     three to six months post-diagnosis. Participants are taught EFT in telephone and internet     group coaching sessions, and have access to an online support forum. They complete the     Mini-Mental Adjustment to Cancer Scale (Mini-MAC), EORTC Quality of Life scale, the PTSD     checklist, the Patient Health Questionnaire, and a brief health checklist. Participants also     provide medical records confirming their diagnosis, and markers, both before and after the     study. The study is expected to enroll 20-15 cholangiocarcinoma patients, and use a     within-subjects, time series, repeated measures design. Symptoms are assessed prior to     coaching, after four, and again after eight weekly coaching sessions. Follow-ups will occur     in one month, three months, and one year. It is hypothesized that a drop in the severity of     co-occurring psychological symptoms, pain and insomnia may occur after EFT coaching.   "
220571|NCT00737412|"     The purpose of this study is to determine the efficacy of Bio-K+ CL1285 in reducing     traveler's diarrhea.   "
220572|NCT00737425|"     The purpose of this study is to evaluate safety and efficacy of PainShield device, based on     ultrasound technology, for postoperative pain relief and wound healing following a     laparoscopic-assisted abdominal surgery.   "
220573|NCT00737438|"     This study is being done to find out how effective a new treatment strategy is on your     cancer. In this strategy, the response your tumor has to the first cycle of therapy will help     select the next treatments. We also will find out the effects, both good and/or bad, a drug     called bevacizumab has on you and your tumor when given with chemotherapy.   "
220574|NCT00737451|"     Increase prevalence of thyroid autoimmunity is found in patients with chronic urticaria.     About 5-34% of chronic urticaria patients is associated with the presence of thyroid     autoimmunity who are euthyroid status whereas 5-10% of them with either hyperthyroidism or     hypothyroidism.   "
220607|NCT00740922|"     The purpose of this study is to retrospectively evaluate the safety of sterile becaplermin     gel compared with sterile placebo gel treatment 12 months or more after the last dose was     administered in 1 of 2 double-blind trials [neither the physician nor the patient knows the     name of the study drug (PDGF-DBFT-003 and PDGF-DBFT-005].   "
220576|NCT00737477|"     This single-arm study will assess the efficacy and safety of monthly administration of SC     Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease     on peritoneal dialysis. Participants currently receiving maintenance treatment with SC     erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with     the starting dose derived from the last weekly ESA they had been receiving.   "
220577|NCT00737490|"     The purpose of this study is to determine whether using an echocardiogram (a painless test     where ultrasound is used to see your heart) while using mild electrical stimulation from your     own CRT-D device to stimulate the ventricles (the lower chambers of the heart) to squeeze one     slightly earlier than the other will show a sustained increase your heart's productivity     (Cardiac Output (CO)), following implantation of a Cardiac Resynchronization Device (CRT-D).     We believe that squeezing some parts of the heart earlier than others may make the heart a     stronger pump.   "
220588|NCT00740675|"     Adverse drug events (ADEs) after hospital discharge are common. The purpose of this research     study is see if we can design an electronic tool given to your primary care provider (PCP)     that will reduce adverse drug events, hospital readmissions, and emergency department visits     after you are discharged from the hospital.   "
220589|NCT00740688|"     This is an experimental study to examine whether a chiropractic intervention (specifically     Logan Basic Technique) can help restore balance distribution in individuals with or without     vertebral subluxations.   "
220590|NCT00740701|"     Functional neuroimaging studies have shown that the cerebellum is active during cognitive     performance. The investigators hypothesize that stimulation of the cerebellum with     transcranial magnetic stimulation will produce brief changes in performance of the task,     suggesting that cerebellar activation is necessary for normal cognitive function.   "
220591|NCT00740714|"     The purpose of this study is to evaluate the safety and effectiveness of high dosages of     Coenzyme Q10 in slowing clinical decline in people who have early Parkinson disease.   "
220578|NCT00737503|"     The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS)     field area of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)     to determine the population effectiveness of Rotarix in Bangladeshi children. Villages in     both intervention and government comparison areas will be included in this evaluation. We     propose to introduce Rotarix into half of the villages of the Matlab HDSS. In villages     randomized to receive the vaccine, all eligible children will be offered Rotarix during their     first two Expanded Programme on Immunization (EPI) visits, as would routinely be done if     Rotarix were included in the Government EPI schedule. In villages randomized not to receive     Rotarix, children will receive their EPI vaccinations exactly as they would have in the     absence of this study. Administration of Rotarix will be conducted by regular EPI staff, but     ICDDR,B study staff will be present to document informed consent and collect study-specific     information. The Ministry of Health will be an active partner in this evaluation since they     will be the agency which may follow up with any subsequent vaccine programme. Vaccination     with Rotarix will be recorded on the infant's immunization card which is normally used by the     EPI programme, but also on a separate study-specific data collection form.      Vaccination with Rotarix will continue from study initiation through June 30, 2011.     Surveillance for rotavirus gastroenteritis will occur at Matlab Diarrhoeal Hospital and the     community treatment centres of the Matlab HDSS continuously throughout the study period.     Diarrheal illness information collected through surveillance will be linked to Rotarix     study-specific data through the subject's HDSS identification numbers. The primary study     endpoint will be the occurrence of an illness episode of acute diarrhoea, among infants and     children admitted to a medical facility, determined to be caused by wild-type rotavirus found     in a stool specimen. At the end of the surveillance period, rates of this primary study     endpoint among age-eligible infants will be compared for villages randomized to receive     Rotarix versus for villages randomized not to receive Rotarix. We expect that the rates of     rotavirus diarrhoea will be significantly lower among children from the vaccinated villages.      The first participant was enrolled in the study on September 23, 2008. Till date (May 12,     2010) a total of 2,882 participants have been enrolled and received first dose. 2,684     participants received second dose of Rotarix. There were 1013 cases gastroentritis reported     to diarrhoeal treatment centres among <2 years old children from the vaccinated and     unvaccinated villages. There were six death cases among the children who received Rotarix     vaccine. These death cases were not related to the vaccines/study products.   "
220579|NCT00737516|"     The National Marrow Donor Program (NMDP) has established a system for registering, matching,     and tracking unrelated donor cord blood units (CBUs) and transplant outcomes. Study subjects     are donors who enroll through collaborating cord blood banks. This study creates uniform     collection, screening, testing and storage requirements for cord blood units. The purpose of     standardization is to improve efficiency in the selection of cord blood units for     transplantation.   "
220580|NCT00737529|"     To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle     cell lymphoma who have relapsed, progressed or are refractory to bortezomib.   "
220581|NCT00737542|"     The objective of this prospective, double-blinded, placebo-controlled, randomized study is to     evaluate the impact of preemptive analgesia using incisional site infiltration of lidocaine     as compared to saline solution on post operative pain control in women undergoing cesarean     deliveries.   "
220582|NCT00737555|"     The treatment of cancer often involves the use of more than one drug at the same time. In     this study, patients are treated with the already marketed drug paclitaxel (administered     every 3 weeks by infusion)and with the investigational drug CHR-2797 (given orally, once     daily). The purpose of this study is to evaluate if it is safe to administer these two drugs     together, and how well the combination is tolerated by patients. The first patients will     receive a 90mg dose of CHR-2797; doses will be increased in subsequent patients, as long as     they are adequately tolerated.   "
220583|NCT00737568|"     The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain     suppression of viral replication to prevent the emergence of complications, which requires     long-term therapy. Durable suppression of viral replication is achieved in the treatment of     chronic viral diseases by preventing of the emergence of drug-resistant mutations. The     clinical guidelines for the management of lamivudine resistant patients are variable. Some     recommend switching to another agent without cross-resistance, while others recommend adding     on another agent without cross-resistance. Limited clinical data exists to demonstrate     whether tenofovir disoproxil fumarate (tenofovir DF; TDF) is an effective monotherapy for     lamivudine resistant patients or if it should be used as part of a combination therapy     regimen.      This study is designed to evaluate the effectiveness, safety, and tolerability of tenofovir     DF monotherapy versus emtricitabine (FTC)/tenofovir DF combination therapy in participants     with chronic HBV with lamivudine resistance (presence of the rtM204I/V mutation with or     without the rtL180M mutation) over a 240-week period. Participants in this study must be     receiving lamivudine treatment at the time of enrollment.   "
220584|NCT00737581|"     The purpose of this study is to characterize subjects' response to spinal cord stimulation     with postural changes.   "
220585|NCT00737594|"     The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at     two dose levels) as compared to placebo for lowering portal hypertension.   "
220586|NCT00737607|"     The study is a prospective outcome study to evaluate the effectiveness and treatment outcomes     of microendoscopic decompressive laminotomy (MEDL) with objective evaluation tools. The     patients who fulfill the selection criteria will be enrolled to collect the pre-operative     clinical data including demographic data, image studies, and functional evaluation for     neurological symptoms and disability.      The patient will receive MEDL and post-operative follow-up will be arranged at 1 week, 1     month, 6 months, and 12 months after the operation. All the collected data will be analyzed     to evaluate the efficacy and treatment results of MEDL.   "
220618|NCT00741065|"     Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock     wave therapy in combination with coronary artery bypass grafting.   "
220619|NCT00741078|"     The investigators hypothesized combination therapy would be superior to monotherapy.   "
220620|NCT00741091|"     CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early     clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in     routine clinical practice and to assess the adequacy of the Boston Scientific Corporation     (BSC) Carotid Stenting Training Program.   "
220587|NCT00740662|"     An important step during a gastric bypass operation for the treatment of morbid obesity is     the measuring of the small bowel length. At several reoperations we found a length increase     of the lowest part of the small intestine of up to 80% compared to the measured length at the     initial operation. On the one hand, this reflects a normal technical error of small bowel     measuring due to the variable state of contraction of the bowel, but on the other hand, it     could also be due to a compensatory increase in intestinal length after the operation. New     protocols allow measuring of the small bowel length by MRI. Comparing the preoperative and     later on several postoperative measurements by MRI with the initial intraoperative length     measuring should allow to validate the new MRI protocol and in the same time quantify the     eventual small bowel length increase. We plan to include 20 patients in this study.   "
220592|NCT00740727|"     Test whether Basic Life Support (BLS) providers can successfully place Enzymatically     Augmented Subcutaneous Infusion (EASI) Access lines for subcutaneous infusion, and     characterize intravascular absorption of EASI-administered (tracer-labelled) glucose (D5W).   "
220593|NCT00740740|"     The purpose of this study is to identify possible in vivo biochemical and biological markers     related to aortic wall strength.   "
220594|NCT00740753|"     Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their     cancer. The purpose of this protocol is to provide supervised access at Oregon Health and     Science University to Y-90 treatment to provide these patients access to an alternate     therapy. The radioactive beads are placed directly near or into the liver tumor with the     intention of destroying the tumor cells.   "
220595|NCT00740766|"     The aim of this prospective randomized study is the prevention of excessive weight gain in     obese pregnant women. The study will compare perinatal outcomes of obese pregnant women     treated in the traditional way to outcomes of nutritionally monitored obese pregnant women     and evaluate a preliminary behavioral model applicable to the general practice of obstetrics.   "
220596|NCT00740779|"     The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with     placebo in the treatment of subjects with moderate to severe abacterial chronic     prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary     objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.   "
220597|NCT00740792|"     The purpose of this study is to determine if two allergy medications (formulated azelastine     and fluticasone product) are more effective than placebo or either medication alone     (azelastine or fluticasone)   "
220598|NCT00740805|"     This phase I trial studies the side effects and best dose of veliparib, cyclophosphamide, and     doxorubicin hydrochloride when given together in treating patients solid tumors or     non-Hodgkin lymphoma that has spread to other areas of the body or cannot be removed by     surgery. Veliparib may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Giving     veliparib, cyclophosphamide, and doxorubicin hydrochloride may kill more cancer cells.   "
220599|NCT00740818|"     The purpose of this study is to determine the effects of Logan Basic Technique on symptoms of     dysmenorrhea.   "
220600|NCT00740831|"     This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month     period for the pre-operative treatment of pre-menopausal women suffering from excessive     uterine bleeding due to uterine myoma.   "
220601|NCT00740844|"     This multicentre open-label randomized parallel-group trial aims to evaluate the association     intermittent pneumatic compression + elastick stockings versus elasting stockings alone on     symptomatic or asymptomatic venous thromboembolism incidence, evaluated systematically at day     6 (+/-2days), in patients hospitalized in intensive care units and with high bleeding risk.   "
220602|NCT00740857|"     This is a study of healthy volunteers to compare how quickly different ibuprofen products     relieve dental pain.   "
220603|NCT00740870|"     The primary objective is to confirm the long-term functionality of implantation of the     Medtronic Melody TPV at 5 years is no worse than the historical control established through     literature review. The secondary objectives are to assess safety, procedural success, and     clinical utility of transcatheter implantation of the Melody TPV.   "
220604|NCT00740883|"     Rational: After 3 or 6 months of oral anticoagulation for an episode of acute venous     thromboembolism (VTE), the risk of recurrent VTE is high (10 to 15% per year) in comparison     with a low risk of recurrence if VTE was provoked by a major transient risk factor such as     recent surgery (3% per year) independently of the initial presentation (deep vein thrombosis     or pulmonary embolism). After a first episode of idiopathic VTE, 3 months of anticoagulation     is associated with a very high risk of recurrence (27% per year); however, the benefit-risk     of extended duration of anticoagulation (1 to 2 years) remains uncertain, mainly in relation     with an increased risk of anticoagulant related bleeding. Therefore, the last ACCP conference     group recommended 6 months of oral anticoagulant therapy after a first episode of idiopathic     VTE. However, this recommendation is likely to be inadequate for at least two main reasons:     (1) no studies compared 2 years to 6 months of anticoagulation after idiopathic VTE; and (2),     if the frequency of recurrent VTE is similar after deep vein thrombosis and pulmonary     embolism, however, the case fatality rate of recurrent VTE is higher after pulmonary embolism     (12%) than after deep vein thrombosis (5%).      Objective : the main objective is to demonstrate that, after 6 months of oral anticoagulation     for a first episode of idiopathic pulmonary embolism, 18 months of warfarin therapy is     associated with a lower cumulative risk of recurrent VTE and major bleeding in comparison     with that on 18 months of placebo. The secondary objectives are: (1) to determine the risk of     recurrent VTE after 6 months of warfarin therapy and the presence or the absence of residual     lung scan perfusion defect and the persistence or not of elevated D-dimer test; and (2), to     determine the impact of extended duration of anticoagulation on the risk of VTE after     stopping anticoagulant therapy on a follow-up of 2 years.      Method : French multicenter double blind randomized controlled trial. Inclusion and exclusion     criteria and pulmonary diagnostic criteria have been defined. After completing 6 months of     oral anticoagulation, a lung scan and D-dimer testing are performed; the investigators and     the patients will be unaware of the results of these tests. Then, patients are randomized to     receive 18 months of warfarin therapy or 18 months of placebo (the dose of placebo will be     adapted according to false computer generated INR). The investigators, the radiologists and     the patients are blinded of the treatment allocation. The project will be submitted to     national ethical committee and written consent will be obtained from all included patients.      Required number of patients: the expected cumulative frequency of recurrent VTE and major     bleeding over 18 months is 4.5% while on warfarin therapy and 16% while on placebo. For a α     risk of 5% (to falsely conclude to a true difference) and a β risk of 10% (to falsely     conclude to an absence of difference), 178 patients per group should be included. As 5% of     patients are expected to be loss, a total of 374 patients is required.      Feasibility: about 50 patients per year are hospitalized in our department of medicine in     Brest for an acute episode of idiopathic pulmonary embolism. Four additional centers will     participate to the study and have a similar recruitment: HEGP (Pr Meyer, Dr Sanchez), CHU     Antoine Béclère (Dr Parent, Pr Simmoneau), CHU Saint Etienne (Pr Mismetti, Pr Décousus), CHU     Grenoble (Pr Pison, Pr Carpentier). The study will be coordinated by the Clinical Center of     Investigation of Brest Hospital; true and false INR will be generated by the clinic of     anticoagulant of Ile de France (Dr Cambus).      Clinical implications: the first consequence of the study is to demonstrate that 6 months of     warfarin therapy is inadequate and should be continued for at least 18 additional months     after a first episode of idiopathic pulmonary embolism. This study has also the potential to     confirm or not the contribution of lung scan and D-dimer testing to appreciate the risk of     recurrent VTE after stopping anticoagulant therapy. Lastly, the medical economical impact of     such therapeutic management will be evaluated.   "
220605|NCT00740896|"     Airway dendritic cells control pulmonary immune responses to inhaled particles. It is the aim     of the present study to investigate the acute effects of smoking on the number and surface     molecule expression of human airway dendritic cells.   "
220606|NCT00740909|"     This study aims to develop a comprehensive Cognitive Behavioral Therapy protocol for adult     patients with Trichotillomania that emphasizes relapse prevention and that addresses comorbid     affective symptoms, as well. The study will compare the efficacy of CBT with a minimal     attention control (MAC)condition. We hypothesize that outcome at post-treatment, 3-month, and     6-month follow-up will be better for the CBT vs. MAC condition including higher responder     rates and greater reduction in hair pulling severity.   "
220646|NCT00741429|"     The main purpose of the trial is to evaluate pulmonary function in subjects who had completed     any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an     additional 2-month safety follow-up.   "
220608|NCT00740935|"     Universal rotavirus vaccination program for infants born in Brest after February 2007,     applied by the Centers for Maternal and Infant Health Protection, pediatricians and general     practitioners.      Prospective surveillance of hospitalizations for gastroenteritis within the Pediatric Units     of Brest University Hospital with systematic testing for Rotavirus.      Evaluation of the impact of the vaccination program on rotaviral gastroenteritis     hospitalizations from 2007-2008 and 2008-2009, by comparison with epidemiological data from     2002-2007 in the absence of vaccination.      The principal judgement criterion is the number of pediatric hospitalizations for rotaviral     GEA during the 2008-2009 epidemic in children A) under the age of 2 and B) residing in the     suburbs of Brest.   "
220622|NCT00741117|"     The purpose of this study is to determine if higher levels of bilirubin in the blood of     people with liver disease affects how accurate a pulse oximeter machine is able to measure     the concentration of oxygen in the blood. Previous studies have reported conflicting results     regarding the affect of high levels of bilirubin in the blood on the accuracy of the pulse     oximeter reading. Initial studies showed an underestimation of the oxygen concentration in     the presence of elevated bilirubin. Subsequent studies have suggested that high levels of     bilirubin in the blood do not influence the accuracy of the pulse oximeter machine. However,     recent reports in bone marrow transplant literature and our personal observations in patients     with liver disease suggest that high bilirubin levels are associated with an overestimation     of the oxygen concentration as measured by the pulse oximeter machine.   "
220639|NCT00741338|"     The purpose of this study is to see if treatment with an antigen-specific immunosuppressive     can decrease or stop an antibody response to laronidase (Aldurazyme®) during enzyme     replacement therapy with laronidase in severe Mucopolysaccharidosis I (MPS I) participants.   "
220609|NCT00740948|"     CLINICAL PHASE II INDICATION Sjogren's syndrome RATIONALE Sjögren's syndrome (SS) is an     autoimmune disorder affecting 0.2% to 3% of the general population. Pharmacological treatment     can improve the sicca symptoms, often transiently, but they are unable to modify the course     of the disease.Open label studies suggested that low-dose rituximab produced acute and     complete CD20 depletion in blood and tissue; was well tolerated without corticosteroid use;     and significantly improved glandular and extra-glandular manifestations of pSS. Larger     controlled studies are now warranted. Our hypothesis is that two infusions of 1000 mg of     Rituximab may be better than placebo to treat patients suffering from pSS. To test this     hypothesis, we propose to compare patients with recent and/or severe pSS treated with either     Rituximab or placebo.      OBJECTIVES Primary objective : Evaluation of the efficacy defined as a 30% improvement     between Day 1 and Week 24 in the values on 2 of the 4 VAS measuring global scores of the     disease (activity of the disease including extra glandular manifestations), joint pain,     fatigue, and the most disturbing dryness.Secondary objectives : Variations from baseline to     week 24 of:      The 0-100-mm VAS scores for dry mouth, dry eyes, dry trachea, dry vagina, and dry skin;     fatigue; pain; Tender and swollen joint counts; Tender points; Other systemic manifestation;     Unstimulated salivary flow rate; Schirmer and van Bijsterveld scores (2-3); C-reactive     protein (CRP) and erythrocyte sedimentation rate (ESR); rheumatoid factor (RF); ANA; serum     IgG, IgA, and IgM; complement; cryoglobulinemia; and counts of B and T cells; Evaluation of     the safety of Rituximab during the study Evaluation of the improvement evaluated on VAS by     the physician Evaluation of the disease activity scores as suggested by Bowman and Vitali     Evaluation of Chisholm score, B cells characteristics and DNA microarray on labial accessory     salivary gland (SG) biopsy samples, and salivary gland echography at inclusion and at week     24.      TRIAL DESIGN Multicenter, randomized, double-blind, placebo-controlled trial NUMBER OF     SUBJECTS : 120   "
220610|NCT00740961|"     RATIONALE: Learning about changes over time in older patients' ability to function after     receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term     effects of treatment and plan the best treatment.      PURPOSE: This clinical trial is studying older patients with newly diagnosed breast cancer or     colon cancer.   "
220611|NCT00740974|"     Long-term cognitive outcome study of children who participated in randomized trials of     LCP-supplemented formula during infancy.   "
220612|NCT00740987|"     This multicentre open-label randomized parallel-group trial aims to compare the association     of intermittent pneumatic compression of the lower limbs + elastic stockings + anticoagulant     prophylaxis to anticoagulant prophylaxis alone on the incidence of venous thromboembolism     systematically evaluated at day 6, in patients hospitalized in intensive care units and     without high bleeding risk.   "
220613|NCT00741000|"     Observe the effects of Cervical Stairstep on Cervical Spine Range of Motion   "
220614|NCT00741013|"     In this randomized, double-blind, placebo controlled trial we used positron emission     tomography to determine if lovastatin or recombinant human activated protein C exhibit     anti-inflammatory effects in humans following intrabronchial installation of     lipopolysaccharide (LPS or endotoxin).   "
220615|NCT00741026|"     The purpose of this clinical research study is to examine the acute hormonal and metabolic     effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The     hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2)     rapidly alters glucose tolerance in healthy volunteers. These questions will be answered by     having volunteers undergo two glucose tolerance tests in a crossover study design.   "
220616|NCT00741039|"     Infections due to influenza and pneumococcus can be very serious and cause death. Anyone can     get these infections. However, some people are at greater risk from the disease, including     people 65 and older, the very young, and people with special health problems such as people     with certain types of cancer, heart, lung, or kidney disease, or diabetes. Influenza can     cause a very serious lung infection (pneumonia) and increase the risk of stroke and heart     attacks. Pneumococcal disease can lead to serious infections in the lungs (pneumonia), the     blood (bacteremia), and the covering of the brain (meningitis). People with the special     health problems mentioned above are even more likely to die from the disease. Although there     are drugs to treat these infections, they are not always effective. This makes prevention of     the disease through vaccination even more important.      This study will look at the body's response to influenza and pneumococcal vaccination. We     want to see how well they it will protect. Immunization is the same as vaccination. Our goal     is to protect as much as we can. We are doing the study because more information is needed to     see how well older patients with cancer respond to these vaccines and how well they protect     against disease caused by influenza and pneumococcus.   "
220617|NCT00741052|"     Cholera is an important diarrhoeal disease and an important cause of death, particularly     during epidemic outbreaks, in Bangladesh and many other developing countries. Used as an     adjunct to management of dehydration, antimicrobial therapy using an appropriate agent     reduces diarrhoea duration and stool volume in severe cholera by about half.      The usefulness of antimicrobials has, however, been greatly eroded by the increasing     prevalence of resistant strains of V. cholerae O1. From October 2004 at the Matlab Hospital     and from December 2004 at the Dhaka Hospital of ICDDR, B, V. cholerae strains became     increasingly resistant to tetracycline and erythromycin- two drugs used in the treatment of     severe cholera in adults and children respectively. Because of this high prevalence of     resistance we resorted in early 2005 to using ciprofloxacin for treatment against multi drug     resistant V. cholerae. Although all isolates were susceptible to ciprofloxacin when standard     thresholds for disc-diffusion or E-test were used, but majority of the strains demonstrated a     MIC value of 0.250 µg/ml, over hundred-folds greater than the V. cholerae strains tested in     earlier years, which generally had a MIC of <0.003 µg/ml.      In this randomized, double blind, controlled trial we will assess clinical and     bacteriological response to 12 hourly oral dose of ciprofloxacin for 3 days in which the     first two doses will be 1 g each and the later 4 doses will be 500 mg each, and compare them     with a single 1 g oral dose of azithromycin. We are using azithromycin as the comparator drug     because current circulating V. cholerae isolates are susceptible (MIC ≤ 0.125 µg/ml) to this     azithromycin, and single-dose azithromycin has been evaluated earlier to be effective in the     treatment of cholera.   "
220621|NCT00741104|"     This observational study will explore the Swedish national population of patients with     rheumatoid arthritis (RA) on infliximab maintenance therapy in order to identify patients who     may be eligible for a dose reduction study. Patients will be asked a variety of questions     regarding their treatment dosing and disease activity, and then asked whether or not they     would consider participating in a dose reduction study. Patients in this study will be     described in terms of demographic and disease characteristics.   "
220637|NCT00741312|"     The purpose of this study is to determine the effect of regular aerobic exercise on     endothelial function in pregnancy.   "
220623|NCT00741130|"     Because the measurement of the retinal nerve fiber layer thickness is very sensitive to the     position of measurement, it may be incorrect in patients with the tilted disc. In the present     study, the corrected RNFL thickness by the optic nerve head configuration using the Cirrus HD     OCT will be evaluated. If the corrected RNFL thickness is more sensitive to detect the     localized RNFL defect, the present software should be upgrade to reflect the optic nerve head     configuration.   "
220624|NCT00741143|"     This study is designed to evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in     improving cognition, hemoglobin, iron status and total body iron among school children in     urban Bangalore.   "
220625|NCT00741156|"     The primary objective of this study is to study the acute effects of angiotensin-converting     enzyme inhibitor (ACEI) on systemic, pulmonary and cerebral blood flow in post bidirectional     cavopulmonary connection (BCPC) patients.   "
220626|NCT00741169|"     The purpose of this study is to assess the interactions seen when somebody doses with     TMC435350 and Rifampin (commercial form of antibiotic).   "
220627|NCT00741182|"     The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture     healing in postmenopausal women with fractures of the hip or shoulder.   "
220628|NCT00741195|"     This trial will evaluate the efficacy and safety of docetaxel plus bevacizumab in patients     with pretreated, advanced non small cell lung cancer (NSCLC).   "
220629|NCT00741208|"     The purpose of this study is to determine if dietary supplementation with soy isoflavones in     persistent asthma improves airway reactivity as determined by PC20 to methacholine.   "
220630|NCT00741221|"     This trial will evaluate the efficacy and safety of pemetrexed and bevacizumab combination in     patients with pretreated, advanced non small cell lung cancer (NSCLC).   "
220631|NCT00741234|"     This is an open label, dose escalation study with 3 arms (Arms A, B, and C). Arm A will     assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with     advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in     cohorts of patients with advanced hematologic malignancies. Arm C will assess the safety and     tolerability of SB939 in combination with standard azacitidine therapy.   "
220632|NCT00741247|"     The purpose of this study is to find a role of EUS-B-FNA in the mediastinal staging of     potentially operable lung cancer. The investigators perform EBUS-TBNA and EUS-B-FNA on     potentially operable lung cancer patients. The investigators perform EBUS(+/- TBNA) and EUS-B     (ultrasonographic examination through the esophagus) on all subjects. EUS-B-FNA will be     performed on inaccessible nodes or difficult nodes to be sampled by EBUS-TBNA. Additional     diagnostic values of EUS-B-FNA as compared to EBUS-TBNA alone will be estimated.   "
220633|NCT00741260|"     This is a world wide phase 1/2, open-label, study of neratinib in combination with     capecitabine, conducted in 2 parts.      In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the     combination of neratinib and capecitabine. Each subject will participate in only 1 dose     group.      Additional subjects may be included at any dose level to further assess the safety and     tolerability at that dose level.      In Part 2, up to 60 subjects with erbB-2 positive metastatic breast cancer will receive     treatment with the combination of neratinib and capecitabine at the maximum tolerated dose     level, as determined in Part 1. In addition 20 subjects with prior lapatinib exposure will be     enrolled in Part 2.      Depending on the safety and activity profile observed during the dose escalation phase, the     dose selected for Part 2 may be adjusted, if appropriate. In case one test article of the     combination is discontinued due to intolerance the other test article can be administered     alone.      The primary objectives of Part 1 are to assess the safety and tolerability, and to define the     Maximum tolerated dose (MTD) of neratinib in combination with capecitabine in subjects with     advanced solid tumors.      The primary objective of Part 2 of this study is to confirm the MTD determined in Part 1.      The secondary objective of Part 1 is to collect information on preliminary anti-tumor     activity of the combination of neratinib and capecitabine.      Secondary objectives for Part 2 are to collect pharmacokinetic information and to obtain     additional efficacy data, such as Objective Response Rate, for subjects with erbB-2 positive     breast cancer treated at the MTD of neratinib + capecitabine.   "
220634|NCT00741273|"     This study will evaluate the safety and pharmacokinetics of two doses of orally administered     Proellex® in female patients with impaired hepatic function and healthy volunteers with     normal hepatic function.   "
220647|NCT00741442|"     The purpose of this study is to determine whether RDEA806 is effective in the treatment of     hyperuricemia in gout patients.   "
220648|NCT00741455|"     The purpose of this study is to determine disease-free survival, overall survival, time to     progression, regimen-related toxicity and/or treatment-related mortality in patients with     hematologic malignancies treated with non-myeloablative chemotherapy followed by allogeneic     stem cell transplant.   "
220649|NCT00741468|"     This study will assess possible drug-drug interactions with specific isoenzymes over a total     study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples     collected post dose will be analyzed.   "
220635|NCT00741286|"     RATIONALE:        -  Elevation in pulsatility indices (PIs), measured by transcranial Doppler (TCD), has been          postulated to reflect downstream increased vascular resistance caused by small-vessel          disease (SVD).        -  Small arterial vessels are a significant determinant of vascular resistance and PIs are          elevated when SVD is present in the intracranial circulation.        -  Cilostazol, a phosphodiesterase III inhibitor, has other non-antiplatelet effects, such          as vasodilation and neuroprotective effect. It has been shown to be effective in the          secondary prevention of stroke especially in the SVD and it may be related to the other          non-antiplatelet effects of cilostazol.      OBJECTIVES:        -  In this study, we aim to investigate whether cilostazol affects the changes of PIs in          patients with acute lacunar infarction using serial TCDs.        -  Our hypothesis is that cilostazol has other non-antiplatelet effects such as          vasodilation effect and may decrease the vascular resistance in patients with acute          lacunar infarction. Hence, cilostazol will decrease the PIs in patients with acute          lacunar infarction.   "
220636|NCT00741299|"     The purpose of this study is to examine whether tobacco smoking is associated with bipolar     affective disorder (severity of depressive and manic symptoms, presence of psychotic     symptoms, history of a suicide attempts and other clinical features.)   "
220641|NCT00741364|"     There is much interest in understanding the role that vitamin D3 (cholecalciferol) plays in     various cancers, and in the prognosis of various cancers once they are discovered. The     purpose of this study is to examine the effects of vitamin D on prostate cancer-associated     lesions and on vitamin D metabolites in prostate tissue. We will give vitamin D3 to men when     they are scheduled to have their prostate removed because of cancer. The men will take     vitamin D at one of 3 doses for 4-6 weeks, until the surgery is performed. We will compare     the prostate tissue taken from the men receiving the higher doses of vitamin D to tissue from     men assigned to the lower doses. We expect to find that the prostate removed at surgery from     men who received the high-dose vitamin D treatment will appear more normal, and less cancer     like. In addition, we will measure vitamin D metabolites in the prostate to confirm that     these did accumulate in the prostate to bring about the effects observed.   "
220642|NCT00741377|"     This study has two portions, a phase I portion and a phase II portion. The purpose of the     phase I portion is to assess the maximum-tolerated dose (MTD) and to characterize dose     limiting toxicity (DLT) of escalating doses of BHQ880 (up to a maximum dose of 20 mg/kg) in     combination with standard chemotherapy and zoledronic acid in relapsed or refractory multiple     myeloma patients.      The phase II portion of the study will also be conducted in relapsed or refractory multiple     myeloma patients. Patients will be treated with various doses of BHQ880 or placebo in     combination standard chemotherapy. In the phase II portion of the study zoledronic acid will     be added after the first 28 days of therapy with BHQ880 or placebo and standard chemotherapy.     This will allow any BHQ880-related changes in bone biomarkers to be detected in a zoledronic     acid-free environment. The purpose of the phase II portion of the study, is to determine one     or more doses of BHQ880 for further development based on dose-efficacy modeling. Efficacy is     defined as time to first skeletal-related event and change in bone markers for bone     resorption and formation relative to placebo. A skeletal-related event is defined as:        -  Pathologic fracture        -  Spinal cord compression        -  Requirement for either radiation or surgery to bone due to:             -  Pain             -  Prevention of imminent fracture             -  Stabilization of a fracture Biomarker and imaging endpoints will be assessed in               both phases of the study. The pharmacodynamic effects of BHQ880 will be assessed by               measuring biochemical markers of bone formation, resorption, and metabolism in               serum and urine. Charges in serum DKK1 levels will be characterized. The size and               number of lytic bone lesions as measured by bone survey (X-ray) or MRI will be               assessed. In addition, bone mineral density (BMD) will be measured by DEXA scan and               at selected sites with QCT scans.   "
220643|NCT00741390|"     The procurement of blood for SMBG, usually via a finger stick, is considered by many patients     to be the most painful portion of diabetes therapy. This has led to the marketing of smaller     gauge lancets, lancing devices with variable depth settings and blood glucose sensors that     require less blood for measurement.      In this study, two main outcomes were evaluated: The first, which was assessed at Visit 1,     was whether specific combinations of lancets and lancing devices would yield sufficient blood     volume to allow valid assessment of diabetic subjects' glucose levels. The other outcome,     assessed at Visit 2, was the level of pain perceived by subjects during lancing with specific     combinations of lancets and lancing devices. During Visit 2, pain assessment was done using a     Visual Analog Scale and such that for each lancet/lancing device, the lowest lancing device     setting that yielded a valid BG reading for each subject during Visit 1 was used. A third     outcome measure, overall comfort with lancing, was also assessed at Visit 2.      A total of 5 combinations of lancets and lancing devices were evaluated.      These were as follows:        -  BD/33G = BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™          (BGM) and OneTouch® Ultra® test strips)        -  OTM/33G =OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch®          UltraMini™ (BGM) and OneTouch® Ultra® test strips)        -  OTM/28G =OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured          with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)        -  OTU/28G = OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM          measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)        -  ACC/28G= Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured          with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip)      After enrollment and qualification, subjects were assigned to one of 4 intervention arms. The     arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the     subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would     evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to     each arm are shown in the Assigned Interventions Table below.   "
220644|NCT00741403|"     An open label, dose-escalation study to evaluate safety, tolerability, maximum tolerated dose     (MTD), efficacy, and pharmacokinetics (PKs) of CPI-613 given twice weekly for three     consecutive weeks in cancer patients      The objectives of this study are:        -  To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive          weeks.        -  To determine pharmacokinetics of CPI-613 following intravenous (IV) administration.        -  To observe the anti-tumor effects of CPI-613, if any occur.   "
220645|NCT00741416|"     Blood samples and health information (e.g., age at diagnosis, test results) are collected for     the purposes of genetic research. The blood samples are assigned a number and stored in a     repository for safe keeping until they are needed for a research project. Participants are     persons who are healthy (not having high blood pressure, diabetes, or high cholesterol     levels) or persons who have Coronary Artery Disease (CAD) and live in Indiana. Participants     complete a questionnaire at the time the blood sample is drawn and are contacted once a year     to update their health history. Researchers apply to the Fairbanks Institute for use of the     blood samples and health information minus participant names and contact information. Their     research is required to be related to find genes or substances made by genes that may be     involved in Coronary Artery Disease with the purpose of improving the investigators     understanding of the illness potentially leading to the development of new diagnostic tools     for identifying the illness, new treatments,or preventative measures. This study will be     repeated for other disorders like Diabetes and Cancer.   "
220650|NCT00741481|"     Study hypothesis : early decrease in fdg-pet measured SUV max after 1 cycle of chemotherapy     can accurately predict response of chemotherapy as assessed by conventional radiology after 3     cycles of chemotherapy.      FDG-PET imaging will be done at J0 and J14 of a new line of chemotherapy treatment in     metastatic colorectal cancer.      SUV max will be recorded and delta SUVmax will be compared to the results of conventional     radiological evaluation after 3 courses of chemotherapy. Results will also be compared to the     time to disease progression.   "
220651|NCT00741494|"     The purpose of this study is to determine if using microdots of hyaluronan (PICSI) to select     sperm for ICSI will result in increased pregnancies especially with men that have a low     hyaluronan binding score (HBA).   "
220652|NCT00741507|"     Unhealthy alcohol drinking is negatively influencing health of people and costing a large     number of annual finance via secondhand effects. Additionally, unhealthy alcohol use covers     a spectrum that is associated with varying degrees of risk to health. The investigators     hypothesized that unhealthy alcohol drinking resulted in significant increase in anesthetic     requirement during general anesthesia. This investigation would clarify the association     between unhealthy alcohol use and the intraoperative consumption of anesthetics, and provide     clinical evidence for preoperative assessment with respect to the alcohol drinking habit.   "
220653|NCT00741520|"     Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular     disease even in the absence of hypertension. However, there are few data regarding the impact     of OSA on the preHypertension and Masked Hypertension in apparently normotensive patients     with OSA as well as the impact of treatment with continuous positive airway pressure.   "
220654|NCT00741533|"     To study the quality of life of patients earlier diagnosed for cervical cancer and cervical     intraepithelial neoplasia (CIN).   "
223496|NCT00776373|"     Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in     relapsed and refractory patients with aggressive lymphoid malignancies.   "
220655|NCT00741546|"     This study investigates if reduced serum levels of vitamin D concentration are a typical     feature in patient group with low left ventricular function admitted for cardiac surgery     interventions. and also the necessity of more preventive strategies for adequate nutrition of     these patients with more focus on intake of vitamin D before admission to cardiac surgery.   "
220656|NCT00741559|"     The first aim of this study are to evaluate the lobar concordance of FDG-PET and MEG with     intracranial electrographic study in children with intractable partial epilepsy. The second     aim is to determine if the combined role of FDG-PET and MEG improve detection of     epileptogenic zone as defined by invasive intracranial recordings.   "
220657|NCT00741572|"     Interstitial lung diseases (ILD) is a collective noun for various chronic lung diseases,     including sarcoidosis and idiopathic lung fibrosis (IPF). Sarcoidosis is a multi-systemic     disease that includes damage to the lungs in 90% of the patients. Generally, the disease can     be described as a systemic, granulomatous and antigen-driven disorder. IPF is a disease of     only the lungs, in which an unknown cause induces a strong inflammation reaction leading to     acute lung damage that ultimately results in the formation of scar tissue and stiffness of     the lungs.      Unfortunately, the exact cause of ILD is still unknown. It is suggested that environmental     and work-related exposure to various triggers can exert an effect on the course of the     diseases. Examples of such triggers include bacteria, organic agents such as pollen and     cotton dust and inorganic agents like metals and talc. Due to this unknown cause, it is     difficult to treat ILD. Consequently, the current guideline is no medication or     anti-inflammatory agents in severe cases. Unfortunately, this therapy is not completely     effective.      Triggers that are suggested to cause ILD can exert their effects via various mechanisms. On     the one hand, they can induce an inflammatory reaction as we recently demonstrated for     various triggers including instillation material and sicila. During such an inflammatory     reaction, cytokines are released that can induce oxidative stress, i.e. an imbalance between     the formation of and the protection against reactive oxygen species (ROS). On the other hand,     ILD-inducing triggers may directly cause an increased ROS production that subsequently can     evoke an inflammatory reaction.      The objective of the current study is to investigate the individual sensitivity for the     development of ILD after exposure to various triggers. Main focus will be the differences in     the formation of and the protection against ROS as well as the occurring inflammatory     reaction after exposure to such triggers.      Furthermore, a simple blood test will be developed to study and eventually even predict the     individual reaction of subjects to various triggers.      Finally, to fully characterize the development of ILD after exposure to various triggers, the     exhaled air of patients will be studied in order to identify specific markers of oxidative     stress and damage.   "
220658|NCT00741585|"     The HYGIA study was designed to investigate prospectively        1. the prognostic value of ambulatory blood pressure (BP) monitoring among subjects          primarily evaluated at primary care settings        2. the impact of changes in ambulatory BP during follow-up in cardiovascular,          cerebrovascular, metabolic, and renal risk in hypertensive patients        3. the influence of circadian time of treatment in cardiovascular, cerebrovascular,          metabolic, and renal risk in hypertensive patients        4. the prevalence of an altered BP profile as a function of antihypertensive treatment,          circadian time of treatment, age, and presence of diabetes, among other factors.   "
220659|NCT00741598|"     This study will examine whether extended release galantamine, a drug approved by the Food and     Drug Administration to reduce cognitive impairments in people with Alzheimer's disease, can     perform the same function in stable people with bipolar disorder.   "
220660|NCT00741611|"     This is a randomized controlled study of the Bard High Density Mesh Ablation System for     treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh     Ablation System is as safe as and more effective than anti-arrhythmic drugs.   "
220661|NCT00741624|"     applying a material over the exposed stromal bed following refractive surgery to prevent     local abrasion and significantly reduce pain   "
220662|NCT00741637|"     The purpose of this study is to assess the safety and immunogenicity of Peru-15     (CholeraGarde®) vaccine in HIV seropositive adult population of Bangkok Thailand   "
220663|NCT00741650|"     A randomized controlled trial comparing a new approach to musculoskeletal pain consisting of     education and peer involvement to treatment as usual. All local government employees in 1-3     Norwegian municipalities will be invited to participate.   "
220664|NCT00741663|"     The question whether the sequential diuretic therapy, that means using an antialdosteronic     drug at first and adding a loop diuretic in nonresponders, is better than the combination of     the two diuretics from the beginning (combined diuretic therapy) in the treatment of ascites     in patients with cirrhosis is still open. Therefore, the aim of the study is to compare     sequential versus combined diuretic therapy in these patients. One hundred patients will be     randomized into two groups. Group A will receive potassium canrenoate at the initial dose of     200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day     of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to     150 mg/day. Group B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of     furosemide, then increased up to 400 mg/day and 150 mg/day, respectively.      The percentage of responders to dthe diuretic treatment, the time to get the resolution of     ascites and the rate of adverse effects will be compared between the two Groups of Patients.   "
220665|NCT00741676|"     Among surgical methods for gastric cancer, incision about 15 ~20 cm length is prepared for     open gastric cancer surgery while 0.5 ~ 1.2 cm is for laparoscopy gastric cancer surgery.     Complications such as pain, abdominal adhesion, and problems associated with delayed recovery     are common in open surgery because of large incision; however, those complications are less     common in laparoscopy surgery because small sized incision is prepared. Range of surgery for     curative dissection depends on the level of progress of a cancer, i.e., depends on whether     gastric wall invasion, lymph node metastasis, or invasion to adjacent organs presented. Since     recurrence in the lymph nodes after the operation is very common, the most important step in     the gastric surgery is to dissect lymph node completely. According to the gastric cancer     surgery manual published by Japan Gastric Cancer Association, more than D2 lymph node     dissection is essential for improving survival rate in advanced gastric cancer. More than D2     lymph node dissection is relatively safely conducted by open surgery, whereas it is     controversial in laparoscopy surgery because it is very hard to maintain surgical field under     laparoscopic condition. Recently, widened rage of lymph node dissection by using laparoscopy     is possible as laparoscopic surgical techniques are accumulated and new surgical devices are     introduced. According to the case reports, D2 lymph node dissection by laparoscopy surgery     shows similar results to the one by open surgery in aspects of recurrence rate and the number     of dissected lymph node. Also, according to Hur and el., in case of upper gastric cancer,     laparoscopy surgery is more useful to dissect #10 and #11 lymph node.In our prospective case     study, the investigators would like to compare effectiveness, complications, patterns of     recurrence, and survival rate between the two surgical approaches, laparoscopy distal     gastrectomy and open distal gastrectomy. The investigators randomly operate the advanced     gastric cancer patients, who need distal gastrectomy and D2 lymph node dissection. Surgical     methods are selected randomly whether open surgery or laparoscopy surgery. Finally, the     investigators wish our case report to contribute to the establishment of the safety and the     effectiveness of laparoscopy surgery conducted for advanced gastric cancers. Consequently,     our case report will contribute to establish the ideal surgical method for the advanced     gastric cancer patients.   "
220666|NCT00741689|"     The purpose of this study is to assess safety and tolerability of AZD1656 after single     ascending oral doses in Japanese healthy male subjects   "
220667|NCT00741702|"     This randomized controlled trial was designed to assess whether a community-based treatment     strategy implemented by home care nurses would be effective in controlling hypertension in     First Nations people with existing hypertension and type 2 diabetes.   "
221011|NCT00747695|"     The purpose of the study is to evaluate the pharmacokinetics, pharmacodynamics and safety of     rabeprazole after single and multiple daily administration in children between the ages of 1     and 11 years, inclusive, with GERD.   "
220668|NCT00741715|"     The present study is assessing the efficacy and safety of AVE5530 (25mg and 50mg)     co-administered with all approved doses of atorvastatin in a double-blind comparison with     placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary     hypercholesterolemia. The main objective is to evaluate the effects of the association     AVE5530+atorvastatin on LDL-C level reduction after 12 weeks of treatment. The effects of     AVE5530+atorvastatin on other lipid parameters will be assessed as secondary objectives   "
220669|NCT00741728|"     The aim of the present PPS3 study is (1) to assess the determinants of the regulation of     heart rate and blood pressure variations and carotid properties (under different physiologic     stimulations) and (2) to evaluate the respective contribution of heart rate, blood pressure     variations and carotid properties to cardiovascular morbidity and mortality including sudden     death during 10 years at least in healthy considered subjects.   "
220670|NCT00741741|"     The purpose of this study is: to determine the safety, (local) tolerability and plasma     exposure over time of single intramuscular (IM) doses of 600 and 1200 mg of a new formulation     (F006) of TMC278LA, to determine the safety, (local) tolerability and long-term plasma     exposure over time of 2 dose regimens of 4 monthly IM doses of a new formulation (F006) of     TMC278LA., To determine the safety, (local) tolerability and long-term plasma exposure over     time of 1 dose regimen of 4 monthly subcutaneous (SC) doses of a new formulation (F006) of     TMC278LA.   "
220671|NCT00741754|"     The aim of this report was to evaluate the unstimulated whole saliva flow in patients with     head and neck cancers during and after the exclusive radiotherapy with an association of     lauryl-diethylene-glycol-ether sodium sulfate and calcium hydroxide (Hct20). This study was     held at the buccal cancer center of UNESP and involved thirty one patients (n = 31) divided     into two groups: Group 1 had seventeen patients (n = 17) submitted to fractioned radiation     treatment in the head and neck region at the total dose of 7.000 cGy and had Hct20 during the     treatment. Group 2 with fourteen patients (n = 14) started with the use of Hct20 after the     end of radiotherapy. A weekly and measured collection of the index of the total non     stimulated saliva flow was done on the patients of both groups. The values that were obtained     were analyzed statistically through the Bartlett test, the Friedman test and the Wilcox test,     to seek an evaluation of effectiveness of the medication on the prevention of the intense     drop of the salivary flow during the radiotherapy and do avoid the xerostomia during the     post-radiotherapeutic period. The patients from group 1 at the end of the radiotherapy kept     the base index of the total non stimulated salivary flow, the ones from group 2 that used the     medication association after the radiotherapy had a great improvement of total non stimulated     salivary flow and the usage of the Hct20 had a better result on the index of salivary flow     during the radiotherapy.   "
220672|NCT00741767|"     The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing     lung hyperinflation in COPD.   "
220673|NCT00741780|"     This is a long-term observational study of patients that were treated with at least 1 dose of     study treatment (plerixafor or placebo) in the AMD3100-3102 protocol (NCT00103662).   "
220674|NCT00741793|"     This registry is a multi-center, prospective, longitudinal, observational program that will     gather and analyse data on participants treated with infliximab, golimumab, golimumab     Intravenous (I.V) or ustekinumab. Treatment will be prescribed by the physician according to     actual clinical practice or standard of care for Rheumatoid Arthritis (RA), Axial     Spondyloarthritis (AxSpA) , Psoriatic Arthritis (PsA); there will be no randomized     assignments to treatment. At baseline and approximately every 6 months thereafter,     information will be collected to assess safety, clinical outcomes, quality of life,     comorbidities, pharmacoeconomics and treatment regimens among cohorts of participants     receiving infliximab, golimumab, golimumab I.V or ustekinumab for the treatment of RA, AxSpA     and PsA.   "
220675|NCT00741806|"     It is the hypothesis of this study that intranasal vaccination with a single dose of GHB04L1     is safe and induces an immune response against influenza A H5N1. This hypothesis will be     tested in a randomized, double-blind, placebo-controlled, Phase I dose-escalation study     assessing the safety and tolerability of single dose administration of GHB04L1 in healthy     adults. Furthermore, the local and systemic immune response as well as the pharmacokinetic     properties of a single dose of GHB04L1 will be studied as secondary objectives. GHB04L1 will     be escalated according to a fixed dose escalation scheme comprising three dose levels.   "
220676|NCT00741819|"     This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects     following transition from a stable dose of inhaled iloprost (Ventavis).      Subjects are to be evaluated for safety throughout the course of the study while secondary     assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24     following initiation of treprostinil sodium.   "
220677|NCT00741832|"     From the relationship between pathophysiology of chronic obstructive pulmonary disease     (COPD), dyspnea, and dynamic hyperinflation during ventilatory increasing, the investigators     hypothesize that        1. Positive expiratory pressure (PEP) breathing will reduce dyspnea more than normal          breathing during exercise in mild to moderate COPD patients.        2. PEP breathing will improve dynamic hyperinflation during exercise more than normal          breathing in mild to moderate COPD patients.        3. PEP breathing will improve cardiorespiratory function during exercise than normal          breathing in mild to moderate COPD patients.   "
220678|NCT00741845|"     This purpose of this study will be to conduct a double-blind, randomized, controlled clinical     trial to determine the association between intravaginal high dose metronidazole (750mg),     intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole +     200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of     persistent bacterial vaginosis.   "
220679|NCT00741858|"     The study evaluates two materials used for duraplasty of the posterior cranial fossa in     treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix     that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out     of bovine pericardium and has to be sutured during application. The study compares these two     materials used for duraplasty of patients undergoing Chiari surgery in a prospective     randomized fashion to check the rate of surgical complications associated with each material,     patient's outcomes, length of surgery and the hospital stay, etc.   "
226579|NCT00817596|"     Clinical evaluation of the safety and efficacy of the Prometra Programmable Infusion Pump to     accurately supply drug to the intrathecal space for the treatment of chronic pain.   "
220683|NCT00741910|"     Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the     only efficacy measure assessed in this study. The safety of multiple courses of semapimod is     to be determined by the incidence of clinical and laboratory adverse events.   "
220684|NCT00741923|"     This project investigates the effect of regular consumption of commercially available     processed white beans (5 cups per week) on food intake, body weight, blood pressure, satiety     hormones and glycemic response over a 4-week period. We have chosen to provide participants     with canned white beans, the most accessible and frequently consumed bean in North America.     They are inexpensive, a good source of high quality nutrients and ready to eat. Based upon     published literature and short-term studies conducted in our laboratory, we hypothesize that     regular consumption of commercially available canned beans will increase satiety and improve     the control of food intake, body weight, blood glucose and blood lipids.   "
220685|NCT00741936|"     Functional constipation (FC) is a common complaint in clinical practice, but treatment for     this condition in conventional medicine is suboptimal. Complementary and alternative     medicines, especially Chinese herbal medicine (CHM) are used frequently by patients, however,     there is little research evidence about these commonly used CHM. The purpose of the study is     evaluate the efficacy and safety of an ancient CHM formula, MaZiRenWan (MZRW), by comparing     with placebo.   "
220686|NCT00741949|"     Fiberoptic bronchoscopy (FOB) is an important tool for the diagnosis of pulmonary diseases,     more particularly in infectious pneumonia. In patients with severe acute hypoxemic     respiratory failure, FOB may be contra-indicated until the patient is intubated and control     of its oxygenation obtained. In the literature several authors showed that performing FOB     under non invasive ventilation (NIV) preserved oxygenation of the patient; and the recent     French Consensus on NIV recommends performing FOB under NIV in patients with acute hypoxemic     respiratory failure.      Nevertheless this procedure remains uncomfortable in most patients with respiratory failure.     In addition, patient's agitation may lead to desaturation, and compromise the realization of     FOB.   "
220687|NCT00741962|"     The purpose of this study is to determine the safety and efficacy of VR-3 Herbal Blend and     its effects on acute and chronic stress responses.   "
220688|NCT00741975|"     Adolescents are at risk for HIV because of sexual and drug use behavior initiated during     early adolescence, and those with mental health problems appear to be particularly     susceptible. Problems with managing emotions may make it difficult for early adolescents to     make good decisions about sexual and substance use behaviors. This project will develop and     evaluate interventions for early adolescents with mental health issues. An intervention     focused on teaching affect management skills will be compared to an intervention addressing a     variety of health topics to determine which intervention best reduces risk behavior among     this at-risk population.   "
220689|NCT00741988|"     This is a multicenter, non-randomized, Phase II study of patients with previously untreated     NSCLC not amenable to radiotherapy or surgical treatment. The planned enrollment for this     trial is 78 patients (including a 10% rate for inevaluable patients). There will be a total     of 39 patients in each cohort (Cohorts A and B).   "
220690|NCT00742001|"     Feasibility trial to evaluate recovery and survival of RBCs from Mirasol-treated whole blood   "
220691|NCT00742014|"     The primary objective of this study is to examine the effects of Sildenafil, administered     during cardiac catheterization, on right ventricular contractility in children with pulmonary     arterial hypertension.   "
220692|NCT00742027|"     This study will evaluate the efficacy of oral panobinostat in patients with     refractory/relapsed classical HL who have received prior treatment with high dose     chemotherapy and autologous stem cell transplant. Safety of panobinostat will also be     assessed. Other markers that may correlate with efficacy or safety will be explored.   "
220693|NCT00742040|"     The primary objective of this study is to establish a safe and effective method of     up-titration of captopril for hospital inpatients.   "
220694|NCT00742053|"     This study is designed to obtain information for design purposes on use of an ECG guided     monitoring system to aid in the correct placement of PICC lines.      There is no formal study hypothesis.   "
220695|NCT00742066|"     In this study we hypothesize that blocking the angiotensin II AT1-receptor improves the     insulin-induced microvascular dilatation. Objectives: 1. Does blockade of the angiotensin II     AT1-receptor improve the insulin-induced microvascular effects in hypertensive patients. 2.     Does blockade of the angiotensin II AT1-receptor impair the insulin-induced microvascular     effects in normotensive control subjects?   "
220696|NCT00742079|"     This study will examine whether pretreatment with D-cycloserine before cognitive behavioral     therapy can reduce impairments still present in people with stable cases of schizophrenia as     well as determine which traits make schizophrenics most likely to respond to D-cycloserine     treatment.   "
220697|NCT00742092|"     Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period/Two-Treatment     Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in     Patients With Cystic Fibrosis Homozygous for the F508del Mutation   "
220698|NCT00742105|"     This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese     patients with advanced solid tumor.   "
220699|NCT00742118|"     Patients with irritable bowel syndrome (IBS) have increased intestinal permeability. In     addition, mucosal soluble mediators are involved in the pathophysiology of pain in IBS. The     investigators aimed to investigate:        1. paracellular permeability in colonic biopsies of IBS patient        2. the ability of soluble factors from colonic biopsies to reproduce in vitro these          alterations   "
220700|NCT00742131|"     This clinical study is being conducted at two sites to determine the optimum dose, safety,     and tolerability of GSK1363089 treatment in adults with solid tumors. This study is no longer     recruiting subjects.   "
220701|NCT00742144|"     This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of     ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia     (CLL) patients. subject will receive ofatumumab 8 weekly infusions.   "
220702|NCT00742157|"     Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued     compliance to the individualized oral diet and enteral GLN, will result in reduced volume of     TPN infusion/week and/or reduced frequency of TPN infusions/week.   "
220704|NCT00742183|"     The primary objective is to compare the incremental costs (direct and indirect) and benefits     (healing outcomes, quality of life) of using foam silver dressing (Mepilex® Ag) to a Silver     sulfadiazine 1% cream (Silvadene®) from the perspective of the health care provider.      The secondary objectives are to investigate the safety, the tolerance and the performance on     burn status including pain.   "
220705|NCT00742196|"     Retinal nerve fiber layer (RNFL) thickness measurement on the parapapillary atrophy is     incorrect. Because a new spectral domain OCT, the Cirrus HD OCT, uses a movable circle to     analyze the RNFL thickness, we may suggest a new analysis strategy for the parapapillary     atrophy.   "
220706|NCT00742209|"     Purpose of the study is to evaluate dose response relationship, efficacy, safety and     tolerability of target doses of GSK1838262 compared to placebo in the prophylactic treatment     of migraine headache. Once subjects complete the baseline and meet the randomization     criteria, they will complete a 5-wk flexible titration period and then enter the 12 week     maintenance period.   "
220707|NCT00742222|"     PRINCIPAL INVESTIGATORS        -  Rakesh Patel, MD- Radiation Oncologist        -  Peter Beitsch, MD- Breast Surgeon      REGISTRY DESIGN        -  Multicenter, non-randomized, post market registry of intracavitary accelerated partial          breast irradiation in appropriately selected patients.      SAMPLE SIZE AND SITES:        -  Approximately 400 patients may be enrolled.        -  Up to 100 qualified U.S. sites may participate in this registry.      ENDPOINTS:        1. PRIMARY ENDPOINTS             -  Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous               toxicities will be recorded at the following follow-up visits; at six (6) month,               one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.             -  Skin Toxicities - Specific toxicities that can result from radiation therapy will               be recorded at each follow-up visit. The Common Terminology Criteria for Adverse               Events will be used and to be recorded at each follow-up visits; at one (1) month,               six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five               (5) year.             -  Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up               visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3)               year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and               graded in two ways:             -  Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will               be completed at the following visits; at one (1) month, six (6) month, one (1)               year, two (2) year, three (3) year, four (4) year, and five (5) year.        2. SECONDARY ENDPOINTS             -  Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral               breast failure at five (5) years.           This includes:             -  Ipsilateral recurrence within the initially treated volume. (Within the tumor bed)             -  Ipsilateral recurrence of cancer outside of the initially treated volume.               (Elsewhere Failure)             -  Axillary nodal recurrence                  -  Survival - to be recorded at each follow-up visit             -  Overall Survival             -  Disease Free Survival                  -  Device Performance - to be recorded during the balloon applicator placement                    and during the course of the radiation treatments:             -  Ability to deliver treatment             -  Axxent System / Balloon Applicator performance        3. TREATMENT DEVICE      The device to be used is the electronic brachytherapy system for the treatment of early stage     breast cancer with intracavitary accelerated partial breast irradiation. The device     manufacturer is Xoft, Incorporated. All Xoft technology cleared by the FDA for the treatment     of early stage breast cancer can be used in this post market data collection registry.      OVERSIGHT COMMITTEE      Representatives from American Brachytherapy Society (ABS), American Society of Breast     Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study     management.   "
220708|NCT00742235|"     Vitamin D deficiency (low levels of vitamin D in the blood) is a common problem. A recently     discovered protein, called hCAP18, likely plays an important role in the immune system and     may depend on adequate levels of vitamin D. It is not known what levels of vitamin D are     needed to allow the body to make this protein. Nor is it known if giving vitamin D to people     who are found to be deficient will help boost levels of hCAP18. This study aims to clarify     the relationship between vitamin D levels and hCAP18.   "
220709|NCT00742248|"     The purpose of this study is to demonstrate equivalent efficacy between two different     formulations of formoterol (pMDI using HFA-134 propellant and dry powder) on lung function in     adult patients with partially reversible COPD.   "
220710|NCT00742261|"     Study to compare 2 different chemical forms of GSK1363089.   "
220711|NCT00742274|"     The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device     and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B     aortic dissections.   "
220724|NCT00742443|"     This trial is to determine whether Juvista can prevent scar formation or improve the     appearance of scars following scar revision surgery. The trial will involve comparing Juvista     to placebo.   "
220754|NCT00742846|"     The primary objective is to compare the clinical outcomes of patients with a clinical     diagnosis of Adhesive Capsulitis who receive intra-articular versus subacromial steroid     injections.      The secondary objective is to verify that steroid injections in combination with physical     therapy lead to more favorable outcomes than local anesthetic injections in combination with     physical therapy.   "
220712|NCT00742287|"     Smoking has been identified as a key risk factor for the development of cardiovascular     diseases (CVD). It was found that a persistent increase in levels of oxidative stress and     prolonged inflammation play a pivotal role in the pathogenesis of smoking associated CVD.     Oligomeric proanthocyanidins (OPCs) are widely known for their anti-oxidant and     anti-inflammatory effects, in vitro and in vivo. However, there are hardly any studies     available that systematically investigated their acute and long-term effects on vascular     function as well as on established biomarkers of oxidative stress and inflammation in an at     risk population such as smokers.      Therefore, the aim of the present study is to investigate the effects of an eight-week     supplementation with OPCs on vascular function as well as biomarkers of oxidative stress and     inflammation in blood of smokers.   "
220713|NCT00742300|"     While glucocorticoids and immunosuppressants ameliorate manifestations of autoimmune diseases     in many patients, current therapies are insufficient to control the disease in a subset of     patients, and their clinical prognosis remains poor due to the development of vital organ     failure, cumulative drug toxicity and to the increased risk of cardiovascular disease and     malignancy. Immunoablative chemotherapy followed by autologous hematopoietic stem cell     transplantation (ASCT) has recently emerged as a promising experimental therapy for severely     affected patients, providing them the potential to achieve treatment-free, long-term     remission. The rationale for applying ASCT to autoimmune diseases has been the hope that     immunoablation could eliminate inflammation-driving pathogenic cells from the immune system,     and that regeneration of the patients' immune system from hematopoietic precursors could     re-establish immunological tolerance.   "
220714|NCT00742313|"     This is a prospective, randomized trial to see in patients undergoing coronary artery bypass     grafting and endoscopically-harvested greater saphenous vein, if using FloSeal Matrix in the     endoscopically-harvested saphenous vein wound bed decreases bleeding and complications.   "
220731|NCT00742534|"     Premature infants are at risk for developing bronchopulmonary dysplasia (BPD). L-citrulline     may decrease that risk, but we do not know the safety or dose of this drug for use in     premature babies. The purpose of this study is to determine the safety and optimal dose of     intravenous L-citrulline in premature infants.   "
221626|NCT00751790|"     Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate     cancer. It was assumed that during the study treatment >90% of the patients would achieve and     maintain castrate levels of serum testosterone.   "
220715|NCT00742326|"     This study will evaluate the effectiveness of pioglitazone in reducing liver fat content in     patients with HIV and hepatitis C virus (HCV) infections. Fatty liver and accompanying     insulin resistance in patients with HIV and HCV co-infections is associated with inflammatory     changes, liver fibrosis and a poorer response to HCV treatment. Pioglitazone is a drug that     helps to reduce the body's resistance to insulin. It is approved by the Food and Drug     Administration to treat diabetes.      Patients with HIV and HCV co-infections who have hepatic steatosis (fatty liver) may be     eligible for this study. Candidates are screened with a medical history and physical     examination, blood and urine tests, magnetic resonance imaging (MRI) of the liver to measure     liver fat and, if needed, a liver biopsy to confirm the diagnosis of liver steatosis.        -  Participants are randomly assigned to take either pioglitazone therapy or placebo for 48          weeks. This is followed by a second 48-week treatment period in which all participants          take pioglitazone.        -  There are approximately 12 visits during the 96 weeks of the study. Participants will          receive a physical assessment, blood and urine tests at each visit. In addition,          periodic assessments of dietary habits, body composition, oral glucose tolerance          testing, and health related quality of life questionnaires will be completed.        -  A repeat MRI of the liver is performed at 48 weeks and at the end of the study to          evaluate any potential changes in liver fat and inflammation. In addition, there is a          follow-up liver biopsy at 48 weeks and an optional liver biopsy at 96 weeks.   "
220716|NCT00742339|"     From 1999, several studies have showed that the use of vasoconstrictors in association with     albumin are effective in the treatment of hepatorenal syndrome (HRS). The rationale of the     use of vasoconstrictors together with albumin in the treatment of this severe complication of     portal hypertension in patients with cirrhosis is to correct the reduction of the effective     circulating volume due to the splanchnic arterial vasodilatation.In most of these studies     terlipressin, a derivate of vasopressin, has been used as vasoconstrictor as intravenous     boluses moving from an initial dose of 0.5-1 mg/4 hr. In some studies midodrine, an     alpha-adrenergic agonist, given by mouth has been used as vasoconstrictor at a dose ranging     from 2.5 up to 12.5 tid together with octreotide, an inhibitor of the release of glucagon,     given subcutaneously at a dose ranging from 10 µg upt to 200 µg tid. To the day, there isn't     a study comparing terlipressin + albumin versus midodrine + octreotide + albumin in the     treatment of HRS in patients with cirrhosis.Thus, the aim of the study is to compare     terlipressin + albumin vs midodrine + octreotide + albumin in the treatment of the HRS in     patients with cirrhosis.   "
220717|NCT00742352|"     The purpose of this study is to determine whether chemotherapy induces regression in     atherosclerotic plaques in oncologic patients already undergoing PET FDG as part of their     routine assessment.We will use PET FDG to assess whether the inflammation in atherosclerotic     plaques is affected by chemotherapy and anti angiogenic therapy.   "
220718|NCT00742365|"     This study will evaluate a possible tool for predicting future effectiveness of bright light     in treating seasonal affective disorder, winter subtype, and will examine secondary effects     of bright light on cardiovascular risk factors.   "
220719|NCT00742378|"     The Cirrus HD OCT, a new spectral domain optical coherence tomography, has better resolution     than the previous OCT. Reproducibility and discriminating ability of the Cirrus HD OCT for     glaucoma detection will be studied.   "
220720|NCT00742391|"     The purpose of this study is to determine whether topical application of PEP005 is effective     for the treatment of actinic keratoses.   "
220721|NCT00742404|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth and by blocking blood flow to the     tumor. Giving bortezomib together with combination chemotherapy may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome     together with bortezomib and dexamethasone works in treating patients with newly diagnosed     multiple myeloma.   "
220722|NCT00742417|"     The purpose of this study was to evaluate the efficacy and safety of plasma exchange with 5%     albumin in beta-amyloid peptide clearance in cerebrospinal fluid, and its effects in patients     with mild-moderate Alzheimer's disease.   "
220723|NCT00742430|"     The purpose of this study is to determine whether aspirin and clopidogrel resistance measured     with Multiplate function analyser has a good correlation with incidence of major adverse     cardiac events in patients with coronary artery disease (CAD).   "
220725|NCT00742456|"     In this study we will examine if the insulin-induced microvascular effects will occur after a     physiological stimulus (i.e. a oral glucose tolerance test). With that the physiological     importance of the insulin-induced microvascular dilatation can be elucidated. In this study     we hypothesize that oral glucose intake and consequently the endogenous induced     hyperinsulinemia will lead to insulin-induced microvascular dilatation in healthy     normotensive subjects. Furthermore, we suggest that the insulin-mediated microvascular     dilatation, resulting from this physiological induced hyperinsulinemia, will be less in     hypertensive and obese subjects compared to healthy controls.   "
220726|NCT00742469|"     The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14     days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea     compared to placebo.   "
220727|NCT00742482|"     The purpose of the study is to evaluate the efficacy and safety of three doses of HL 10 given     at fixed time intervals compared to standard therapy   "
220728|NCT00742495|"     The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics and safety of     different doses of intravenous and oral Forodesine in children with relapsed or refractory     T-cell or B-cell precursor Acute Lymphoblastic Leukaemia or T-cell Non-Hodgkin's Lymphoma.     Preliminary efficacy will also be assessed.   "
220729|NCT00742508|"     The primary objective of this study is to evaluate the safety and tolerability of     SK&F-105517-D in japanese patients with chronic heart failure.   "
220730|NCT00742521|"     It has been found that in some cases, when a person with Diabetes Mellitus has an episode of     low blood sugar,or hypoglycemia, and then later exercises, he or she is vulnerable to another     bout of hypoglycemia during that exercise. The purpose of this study is to determine what     factors during the previous bout of hypoglycemia might cause another bout of hypoglycemia     while exercising later.   "
220732|NCT00742547|"     Patients with type-2 diabetes mellitus have an higher risk developing secondary disorders. In     an epidemiological longitudinal study of about 1.150 patients with type 2 diabetes mellitus     we investigate determinants and predictors for long-term prognosis. The patients are     recruited and supervised in practices of general practitioners of the administrative district     of Ludwigsburg/Heilbronn (Baden-Württemberg, Germany). In a subgroup of about 200 patients     with a dissatisfactory metabolic status (HbA1c > 7,5%) a randomised interventional study is     performed. The intervention comprises a telephone counseling by the medical secretary of each     practice executed in a predefined period of time. The outcome parameters of interest are the     change of HbA1c, the development of secondary disorders and adverse events, quality of life     and risk factor control, as well as hospitalization and mortality.      The aim of the study was to develop an patient-centred instrument implementable in the     routine medical care in order to enhance the prognosis of patients with type-2 diabetes     mellitus.   "
220733|NCT00742560|"     A Phase 1b/2, Multicenter, Open-label, Dose-escalation Study of Elotuzumab (Humanized Anti     CS1 Monoclonal IgG1 Antibody) in Combination with Lenalidomide and Dexamethasone in Subjects     with Relapsed Multiple Myeloma.   "
220734|NCT00742573|"     This study will determine whether combination treatment driven by patient choice is better     than standardized medication treatment at retaining and improving Hispanic patients with     major depressive disorder.   "
220735|NCT00742586|"     The purpose of this study is to identify 15 patients with autonomic failure and obtain blood     samples for RNA from those participants and 15 control subjects within the same age range.     The stabilized blood samples, along with a limited data set, will be shipped to Western     Michigan University where the actual laboratory analysis (a separate study) of the samples     will take place.      Unique genetic inscriptions, called gene expression signatures, are currently being     identified for many diseases, including neurological diseases. The secondary goal of this     study is to support the research being done at WMU and they try to look for MSA-specific     signs are present in whole blood samples of MSA patients at late-stages of the disease. This     is a pilot study that has a long term goal (through additional studies) a MSA-specific gene     expression signature for the development of a diagnostic test for this disease that can be     used in the future. Other patient groups with autonomic failure, characterized by significant     drop in blood pressure on standing, will also be included in this study, to look for similar     genetic inscriptions.      This pilot study is expected to last for 2 years. The investigators at WMU will need some     de-identified health Information about the subjects, including their age at diagnosis, age     (when sample drawn) and list of their medications   "
220736|NCT00742599|"     Patients who require gastric endoscopy will receive an intragastric single dose of NPO-11 20     mL. The superiority of NPO-11 to placebo as a premedication for endoscopy will be verified in     a randomized, double-blind, parallel-assignment design based on the percentage of patients     having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary     outcome measure).      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions     (ADRs) observed between administration and seven days after administration in comparison with     the placebo group.   "
220737|NCT00742612|"     The purpose of this study is to determine, in patients undergoing carotid endarterectomy, the     effect of ARC1779 Injection on the number of microembolic signals detected by transcranial     Doppler immediately after surgery. This study will also evaluate the safety of ARC1779     Injection with respect to bleeding risk in patients in the peri-operative (during surgery)     period.   "
220738|NCT00742625|"     This phase II trial studies the side effects and best dose of bortezomib when given together     with daunorubicin and cytarabine and to see how well it works in treating older patients with     previously untreated acute myeloid leukemia. Bortezomib may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Giving bortezomib together     with combination chemotherapy may kill more cancer cells.   "
221323|NCT00749970|"     Observational, short-term prospective, multicenter study to assess psychometric properties of     the Spanish version of SWN-K scale in patients with schizophrenia.   "
220739|NCT00742638|"     This is an open label, randomised, parallel-group study to compare the efficacy and safety of     quetiapine and valproate used as monotherapy in the treatment of mania in patients     hospitalised for an acute manic episode. After given of informed consent and undergoing     screening procedures, the patients will be randomised into quetiapine or valproate group on     Day 1. The efficacy of study treatment on symptoms of mania will be assessed at Day 28.     Patients will not permitted to use any psychoactive or antipsychotic medications throughout     the study period other than those expressly permitted by the protocol.      At each centre, the same individual will administer a specific psychiatric assessment for a     patient at all study visits in order to reduce variability in rating scale scoring. Before     the initiation of the study, a consistency assessment will be done among the investigators     who conduct the scale assessment in each centre.   "
220740|NCT00742664|"     Obsessive-compulsive (OC) symptoms are often present among youth with Prader-Willi Syndrome     (PWS). They are also associated with considerable problems in the daily functioning of the     child and his/her family. Although medication and behavioral treatments exist that target OC     symptoms among youth without PWS, these treatments have not been thoroughly adapted for this     population nor scientifically tested. Although medication has been helpful in addressing OC     symptoms in several published case reports, the associated efficacy is modest and the     potential for side effects is a realistic concern. Given that behavioral treatment for OC     symptoms has superior efficacy to pharmacotherapy in youth without PWS without the     accompanying risk for adverse side effects, it follows that an adapted version of behavioral     therapy may hold promise in treating clinically problematic OC symptoms in youth with PWS.     Thus, the purpose of the proposed grant is to develop and pilot-test a behavioral treatment     for OC symptoms for use in youth with PWS. This study will allow us to develop and test a     treatment protocol aimed at reducing OC symptoms that are clinically problematic and     negatively impact functioning and quality of life in the child and his/her family.   "
223683|NCT00778778|"     The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy     and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fasting     conditions.   "
220741|NCT00742677|"     RATIONALE: Abdominal pain and nausea and vomiting may be lessened by waiting after surgery     before eating foods by mouth. It is not yet known which feeding schedule is more effective in     patients undergoing surgery.      PURPOSE: This randomized clinical trial is comparing two feeding schedules after laparotomy     in patients with gynecologic cancer.   "
220742|NCT00742690|"     It is well known that terlipressin and albumin improve renal function in patients with     cirrhosis and type 1 HRS. In previous studies terlipressin has been used either as     intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr or as continuous intravenous     infusion at the initial dose of 2 mg/24 h. Up to now the two schedules of i.v. administration     of terlipressin have never been compared. Nevertheless, it has been hypothesized that     continuous intravenous infusion assures a more steady profile of effect on portal pressure in     patients with cirrhosis. Thus, the aim of the study will be to compare terlipressin given as     i.v. bolus vs terlipressin given as continuous intravenous infusion in the treatment of type     1 HRS in patients with cirrhosis.   "
220743|NCT00742703|"     The principal objective of this research is the evaluation of the effect of mineralized water     consumption upon evolution of LDL Cholesterol and triglycerides, compared to a low     mineralized water consumption.   "
220744|NCT00742716|"     This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK)     in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT),     undergoing regular hemodialysis. This study will also investigate the safety and effects of     different strengths of CTA018, on parathyroid hormone (PTH) levels.   "
220745|NCT00742729|"     Develop and evaluate in a randomized trial an educational small group intervention to     increase colorectal cancer screening among Filipino Americans.   "
220746|NCT00742742|"     The purpose of this study is to determine whether a daily supplement of 30 grams of walnut is     effective in the treatment of metabolic syndrome (MetS).   "
220747|NCT00742755|"     Develop and evaluate a peer navigator intervention to assist Korean women with a potential     breast abnormality, who have missed their first follow-up appointment, to complete all     diagnostic follow-up tests.   "
220748|NCT00742768|"     From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of     vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7.     However, the taste of natto is not appreciated by the western society. For this reason the     active biological compound is produced as a capsule. Different techniques of encapsulation     the vitamin can lead to different absorption profiles with intake. Therefore it is important     to study influence of type of encapsulation technique on absorption of menaquinone-7.      This study is undertaken to compare absorption of menaquinones between two different     encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of     conventional softgel capsules and newly developed GellpelTM capsules are compared between     each other.   "
220749|NCT00742781|"     The purpose of this study is to determine the effect of vitamin D supplementation in Crohn's     disease patients. Patients will be evaluated for increases in circulating vitamin D levels     and effects on health benefits including improved bone markers, Crohn's disease activity     scores, and inflammatory markers.   "
220750|NCT00742794|"     In Switzerland, 3.5% of the population are suffering from hymenoptera venom allergy. The only     causal treatment of hymenoptera alelrty is venom specific immunotherapy. There are however     several reasons, which question the relatively broad application of this expensive treatment.     That's why we aim at investigating the actual risk for hymenoptera stings in patients     undergoing allergen specific immunotherapy against hymenoptera sting allergy   "
220751|NCT00742807|"     Giving infiltration analgesia around the neck of the womb (= paracervical block, PCB) is     frequently experienced as a painful procedure by women undergoing follicle aspiration. Two     sedation protocols, where in the one protocol a low dose of alfentanil hydrochloride is     already administered before the PCB, will be compared with each other and pain relief     measured using the 'Visual Analogue Scale' and the 'Short-Form McGill Questionnaire'   "
220752|NCT00742820|"     To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in     healthy volunteers with calcium citrate as a positive control.   "
220753|NCT00742833|"     To investigate the efficacy and safety of KUC-7483 in overactive bladder patients.   "
221324|NCT00749983|"     The purpose of this study is to determine whether creatine associated or not to exercise     training can improve physical performance in patients with knee osteoarthritis and     fibromyalgia.   "
220755|NCT00742859|"     Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with     non-valvular AF, orally administered betrixaban will provide similar or better efficacy and     safety than warfarin and it will offer the advantage of not requiring dose adjustments due to     INRs outside the target range of 2.0 to 3.0 and a more consistent level of anticoagulation     over time.   "
220756|NCT00742872|"     The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin     receptors in the gastrointestinal tract, is effective in the treatment of     constipation-predominant irritable bowel syndrome (C-IBS).   "
220757|NCT00742885|"     This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK     Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.   "
220758|NCT00742898|"     The purpose of this study is to evaluate the clinical effectiveness of performing opt-out     rapid HIV screening in an urban, inner-city emergency department, as well as to evaluate its     clinical efficiency, cost effectiveness, and patient and staff satisfaction.   "
220759|NCT00742911|"     OBJECTIVES:      Primary Objectives      • Determine the safety and toxicity profile of co-administration of disulfiram and copper     gluconate for the treatment of refractory malignancies that have metastasized to the liver.      Secondary Objectives        -  Determine if disulfiram and copper gluconate induce measurable responses for the          treatment of hepatic metastases from solid tumors.        -  Qualitative assessment of the induction of S-glutathionylation in proteins of          circulating leukocytes in patients treated with disulfiram and copper gluconate.   "
220814|NCT00743275|"     To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009     formulation.      To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion     influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human     Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.   "
220760|NCT00742924|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This clinical trial is studying the side effects and best dose of zoledronic acid     when given together with combination chemotherapy in treating patients with newly diagnosed     metastatic osteosarcoma.   "
220761|NCT00742937|"     The purpose of this study is to evaluate the effect of maternal supplementation with 400,000     IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial     mother-child, on growth and morbidity of children in breastfeeding in the first six months of     life.   "
220762|NCT00742950|"     The investigators' purpose is to study the induced refractive change caused by different     2.8-mm corneal incision locations in phacoemulsification, because the investigators     hypothesize that the effect may be different for nasal, temporal, and superior location,     although they are considered astigmatism neutral.      Patients will be randomized to nasal or temporal incision, or assigned to superior incision,     depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam     analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and     after phacoemulsification.      Outcome measures will be induced corneal refractive change (Fourier power vector analysis),     ISV change, and visual acuity, at 6 months.   "
220763|NCT00742963|"     The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is     safe and effective in the treatment of Advanced Soft Tissue Sarcoma.   "
220764|NCT00742976|"     Hypothesis: Changing type 2 patients treatment from Insulin Insulatard to Insulin Detemir     will increase their excretion of sodium in the urine and thereby decrease their extracellular     volume and body weight. 24 patients are divided into 2 groups and their insulin treatment is     shifted while their body composition, sodium excretion, weight and extracellular volume is     monitored.   "
220765|NCT00742989|"     The goal of this project is to see how much an osteopathic lymphatic treatment (OLT) causes     an increase in plasma volume, total plasma protein concentration, and albumin concentration.     This is an important step in understanding the effects of OLT, specifically its effects on     fluid in the body. The primary role of the lymph system is the return of fluid and proteins     lost from the blood vessels. Despite this, no research has been done to see what effects an     OLT has on fluid and protein levels in the blood.   "
220766|NCT00743002|"     This trial is designed to show the effect of treatment with TT223 or placebo on blood glucose     control after 12 weeks of treatment with a 6 month follow-up. TT223 is administered by     injection once daily to patients currently treated with Metformin and/or Thiazolidinedione.   "
220767|NCT00743015|"     The general aim is to evaluate the relative oral bioavailability of BI 44370 TA tablets     during and between migraine attacks as well as Safety, Tolerability and Pharmacokinetic   "
220768|NCT00743028|"     This is a randomized, open-label, multicenter crossover study to determine the oral     bioavailability of new ABT-263 formulations relative to that of the current ABT-263     formulation being administered in ongoing Phase 1/2a studies. Approximately 36 evaluable     subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors     will be enrolled in this study.   "
220769|NCT00743041|"     A need exists to find fast yet effective treatment protocols for the large number of US     military service personnel coming back from Iraq with post traumatic stress disorder (PTSD),     and a variety of co-occurring psychological problems. EFT (Emotional Freedom Techniques) has     demonstrated promise as a PTSD treatment in pilot studies. This study examines the effects of     six sessions of EFT coaching on veterans who score at or above the military cutoff point for     PSTD. Subjects are also assessed for conditions that often accompany PTSD, such as depression     and anxiety. Changes pain, cravings, and physical symptoms are also measured. Assessments are     made after six sessions are complete, and again after three and six months.   "
220770|NCT00743054|"     In this study, renal cell carcinoma (RCC) related miRNA and the target genes of related miRNA     will be examined in order to investigate the role of miRNA in the formation of RCC and look     for the biomarker of RCC.   "
220771|NCT00743067|"     This clinical study is being conducted at two sites to determine the optimum dose, safety,     and tolerability of oral daily GSK1363089 treatment in adults with solid tumors. This study     is no longer recruiting subjects.   "
220782|NCT00734487|"     The purpose of this study is to identify whether changes in age-related macular degeneration     (AMD) over time as seen with spectral domain optical coherence tomography (SDOCT) imaging,     can be used to predict vision loss and the advancement of AMD in people at moderate to high     risk for progression.   "
220772|NCT00743080|"     To date, laparoscopic approach may apply to several gynecologic diseases. Among the recent     advances in laparoscopy an important role was assumed by the methods of tissue extraction. In     particular electronic power morcellators have become instruments of large use in surgical     practice.      The tissue morcellator is an endoscopic instrument indicated for cutting, coring and     extracting tissue in operative laparoscopy, and it has a pivotal role during specific     gynaecologic procedures as well as myomectomy and hysterectomy. The main advantages offered     by electronic morcellator consist in reduction of operative time and of risk in hernia     formation, this last due to the absence of fascia's tearing or stretching.      Recently, a new generation of tissue morcellator has been commercialized. In particular,     GYNECARE MORCELLEX (Ethicon-Johnson & Johnson Gateway, US) and ROTOCUT G1 (Karl Storz, Culver     City, CA, US) are two tissue morcellators currently available. These instruments seem to     offer advantages over the previous models in terms of precision, speed and durability. The     most useful of this features seems to be the higher speed, in particular it has been     calculated that they morcellate tissues approximately four times faster than those of the     previous generation. The high speed that characterizes this new morcellator potentially     results in reduced operative time with consequent benefits in other surgical outcomes such as     postoperative pain and recovery time.      Even if both morcellator seems to be high-quality instruments, no study was designed until     now to compare these two tools in a prospective fashion.   "
220829|NCT00743470|"     The purpose of this study is to study the safety, tolerability and pharmacokinetics of     rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.   "
233884|NCT00919282|"     The purpose of this study is to examine the efficacy and safety of the drug combination GFF     in patients with advanced pancreatic cancer (APC).   "
220773|NCT00743093|"     The objective of this study is to monitor liver function tests (blood levels of an indicator     of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen     compared to people taking placebo for 16 to 40 days. Those people that continue to have     normal liver tests after 16 days will have completed their part of the study. People that     develop abnormal liver function tests will continue taking acetaminophen or placebo, and have     their liver tests monitored closely for up to an additional 24 days. This is to (1) make sure     these tests return to normal and (2) determine when these tests return to normal while still     taking acetaminophen or placebo. If at any time the liver tests indicate anything more than a     minor increase, you would be immediately told to stop taking the study drug.      Secondary objective is to determine the proportion of subjects that have detectable     acetaminophen-protein adducts after daily dosing.   "
220774|NCT00743106|"     This trial will study the effects of fenoldopam on renal function in patients who have a     single kidney undergoing surgery to remove part of that kidney secondary to renal cell     carcinoma. The investigators will monitor and evaluate throughout the perioperative course     the kidney function. Normally kidney function is predicted to show a worsening followed by an     improvement after surgery.      The investigators want to specifically identify if the use of fenoldopam lessens the injury     to the kidney with this surgery.   "
220775|NCT00743119|"     The purpose of this study is to better understand the potential clinical application of     cannabinoids for pain management, the following study is designed to determine the analgesic     efficacy of smoked marijuana (0. 198, and 3.56% THC) and oral THC (0,10, and 20 mg) in the     Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for     clinical use of analgesics. Both smoked marijuana and oral THC will produce dose- and     time-dependent analgesic effects in the cold-pressor test. Oral THC is known to have a slower     onset and longer duration of action compared with smoked marijuana. Therefore, the analgesic     effects of oral THC is expected to peak later and last longer than effects produced by smoked     marijuana.   "
220776|NCT00743132|"     ARF is a frequent event after hepatic resection and therefore clinically highly relevant.      There is limited evidence on the incidence of postoperative ARF and its clinical relevance in     patients undergoing liver resection.      This study will evaluate the incidence of acute renal failure (ARF) after liver resection and     its impact on postoperative mortality.   "
220777|NCT00734422|"     Procedurally Virtual reality exposure therapy (VRET) is quite similar to models of extinction     of conditioned fears. Recent advances in animal research have identified pharmacological     agents that appear to both accelerate and consolidate extinction learning. One of these     cognitive enhancers is Yohimbine. An interesting finding in animal literature is that the     administration of Yohimbine during extinction trials accelerates fear reduction and may     convert ineffective exposures in to successful ones. It is thought that the mechanism of     enhanced emotional memory is through elevated norepinephrine in the prefrontal cortex.     Therefore, we propose to extend these studies by combining VRET with Yohimbine. In this pilot     study with a between groups design 20 participants with a fear of flying will be treated with     VRET plus Yohimbine or VRET plus placebo. This between groups design was chosen to further     characterize the differential within and between trial extinction. Outcome will be measured     by self-report, behavioral, and psychophysiological assessments at pre- and post-treatment.     In addition, we will examine extinction parameters during exposures.   "
220778|NCT00734435|"     The purpose of this study is to determine if zonisamide SR will prevent weight gain in     schizophrenic subjects who take olanzapine (Zyprexa)   "
220779|NCT00734448|"     Myo-Inositol is an insulin sensitizing agent that ameliorate the insulin resistance in women     affected by gestational diabetes (GDM), but there is no information about the effect on the     glucose profile. Maternal hyperglycemia of GDM, especially hypoglycemic excursions, are     associated with adverse pregnancy outcome. Continuous Glucose Monitoring System (CGMS) is     obviously better than intermittent self monitoring in detecting glucose profile and magnitude     and duration of glucose fluctuations. For this reason, we propose a clinical trial to analyze     the characteristics of glucose variability in GDM women,treated with diet and folic acid     alone or with diet, folic acid and myo-inositol supplementation.   "
220780|NCT00734461|"     This is a single-center, randomized, 7-way crossover, double-blind, active and     placebo-controlled study to evaluate the subjective effects of oxycodone combined with     ultra-low dose naltrexone in comparison to oxycodone alone in non-physically dependent     subjects with a history of opioid abuse. Approximately 14 subjects will be randomized to one     of fourteen sequences selected from a balanced 7x7 Latin square design and its mirror image.   "
220781|NCT00734474|"     This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects     of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring     glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type     2 diabetes mellitus on Metformin.   "
220783|NCT00734500|"     This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in     infants and toddlers less than 24 months of age with suspected serious infection. There will     be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive     anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24     hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling     scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those     observed in older children and adults.   "
220784|NCT00734513|"     The long-range goal of this research is to develop better ways of helping GI cancer patients     and their caregivers cope more effectively with the demands of the disease. The study is     designed to test the hypothesis that a partner-assisted emotional disclosure intervention     will be more effective in enhancing patient' psychological adjustment than a cancer education     condition.   "
220785|NCT00734526|"     The goal of this clinical research study is to find the highest tolerable dose of sorafenib     that can be given in combination with temozolomide. The safety of this combination will also     be studied.   "
220830|NCT00745316|"     The main purpose of this study is to determine the safety and tolerability of tonapofylline     (BG9928) when given at different doses to patients with heart failure and renal     insufficiency.      This study will also explore:        -  Disease related quality-of-life        -  Exercise capacity        -  Renal function        -  Concomitant medications   "
220786|NCT00734539|"     The most common etiology of infection-related death or neurodevelopmental impairment in     neonates with birthweight <750 g is invasive candidiasis. Over 70% of the premature neonates     who develop invasive candidiasis will die or suffer severe, permanent neurologic impairment.     Fluconazole has been commonly used off-label in the neonatal intensive care unit, but     definitive recommendations for its use in the nursery have been hampered by the limited     number of well-designed trials. In neonates weighing <750 g, appropriate dosing is not known,     definitive safety and long-term follow up trials have not been completed, and there have not     been well-powered trials conducted to establish the efficacy of the product using mortality     as part of the primary endpoint. Three recent proof-of-concept studies suggest that     fluconazole will be safe and effective, and a recently completed pharmacokinetic study is     providing data to give preliminary dosing guidance. The next logical step in drug development     is proposed by this research: to conduct a pivotal trial to determine the safety and efficacy     of fluconazole in premature neonates with 2-year neurodevelopmental follow-up assessment.      362 neonates, with a birthweight <750g, were randomized at 33 US centers, to twice weekly     fluconazole (6 mg/kg) or placebo for the first 6 weeks of life. The primary efficacy endpoint     will be Candida-free survival at study day 49. The research will establish definitive dosing,     safety, and efficacy of fluconazole; it will also provide critical information on the effects     of fluconazole on neurodevelopmental impairment and antifungal resistance.      Potential Impact:      Approximately 17,000 neonates are born <750 grams each year in the United States. Over 5000     will die or develop invasive Candida infections. Demonstrating safety and efficacy of     fluconazole in preterm neonates will improve the survivability and long term outcomes for     these neonates.   "
220787|NCT00734552|"     This randomized, open-label, prospective study will evaluate the renal effective effect of     compound α-Keto Acid plus low protein diet in PD Patients.   "
220788|NCT00734565|"     This study will investigate safety and reactogenicity of a monovalent conjugated vaccine     against Haemophilus influenzae type b in healthy children   "
220789|NCT00734578|"     The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with     ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years     with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.   "
220790|NCT00734591|"     In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who     were taking Exubera than in people who were taking other diabetes medicines. All subjects     diagnosed with lung cancer had a history of smoking and the number of lung cancer cases     observed fell within the expected range based on population-based data. There is currently     not enough information to determine if any of the observed lung cancer cases were related to     Exubera use, therefore, the study is being conducted to further investigate whether Exubera     use makes the appearance of lung cancer more likely.   "
220791|NCT00734604|"     The primary purpose of the study is to help answer whether tadalafil taken once a day can     help improve the psychological outcomes (such as sexual self confidence, spontaneity and time     concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).   "
220792|NCT00734617|"     The main goals of the study are to assess benefits of higher doses of the nicotine patch     prior to smoking cessation for high- and low-dependent smokers, and to investigate the     potential relationship between genetic factors and smoking cessation success. There will be a     two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240     high-dependent & 240 low-dependent smokers; half of each group will wear two 21mg nicotine     patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo     patch daily, resulting in the following four conditions (120 subjects each) during the 2-week     pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More     Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will     continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no     longer be double-blind as only nicotine patches will be used: all subjects will wear one     21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg     patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites:     Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have     7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3     weeks, 6 weeks and 10 weeks after the quit-smoking date.   "
220793|NCT00734630|"     This study will assess blood pressure reduction with nebivolol or placebo in patients taking     lisinopril or losartan.   "
220808|NCT00743197|"     The purpose of this study is to compare the effectiveness of standard medical therapy versus     usual care in women with chest pain, coronary endothelial dysfunction and unblocked coronary     arteries.      Coronary endothelial dysfunction (CED) is a condition in which the layers of cells around the     heart do not function properly and is believed to be key factor in the development of     atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased     risk for future cardiovascular events, such as heart attack and stroke.      A coronary angiogram allows physicians to see if any of the arteries in the heart are     blocked, usually by fatty plaque. In many instances, angiograms in women experiencing chest     pain do not show evidence of coronary disease (free of significant plaque build-up).     Currently, there is no standard of care treatment plan for patients with normal coronary     arteries, despite symptoms of chest pain, and as a result these patients may not receive     medical treatment. However, these women often return to their physicians more than once with     chest pain and go through a similar battery of tests.   "
220809|NCT00743210|"     The purpose of this study is to determine if oral of L-citrulline (3 grams/day) for 3 weeks     provided in mid-pregnancy to obese subjects will decrease the plasma ADMA/L-arginine ratio,     lower maternal blood pressure, improve endothelial-dependent vascular function and peripheral     vascular stiffness, and improve uterine artery Doppler resistance and flow.   "
220811|NCT00743236|"     RATIONALE: Warm ischemia is the clamping of blood vessels without cooling the kidney. Cold     ischemia is the clamping of blood vessels with kidney cooling. It is not yet known whether     warm ischemia is more effective than cold ischemia in patients undergoing surgery for stage I     kidney cancer.      PURPOSE: This randomized phase III trial is studying warm ischemia to see how well it works     compared with cold ischemia during surgery in treating patients with stage I kidney cancer.   "
220812|NCT00743249|"     The purpose of this study was to determine the safety and retention times of two different     lengths (10 mm and 20 mm) of the MINI MONOKA canicular stent when inserted in the eye for up     to three months in subjects with or without dry eye.   "
220813|NCT00743262|"     The purpose of this study is to investigate the performance of a new voice prosthesis in     comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized     patients. Factors taken into account are clinician and patient satisfaction with the     insertion system, patient satisfaction with voice, speech, performance, and maintenance.     Voice and speech will also be evaluated for the different prostheses by means of perceptual     evaluations and acoustic analysis.   "
220794|NCT00734643|"     Survival for one of the most complex forms of congenital heart disease, hypoplastic left     heart syndrome (HLHS), has improved dramatically. However, little is known about family     stress, coping and outcomes following the diagnosis of HLHS. It is expected that families     face emotional, social and financial stressors. Health care professionals have a unique     opportunity to positively influence how families interpret and adapt to these stressors. The     specific aims of the study are to describe perceived stress, and coping skills utilized, in     parents of children with HLHS and their impact on family outcomes measured as well-being,     adaptation and caregiver/family quality of life, and to describe changes in stress, coping,     and adaptation and differences in perceptions of mothers versus fathers of children with HLHS     over the first 14 months of life. The Resiliency Model of Family Adjustment and Adaptation     (McCubbin, Thompson, & McCubbin, 1996) is the theoretical framework that guides this     research.      Hypotheses:        1. Family perception of stress, and coping skills utilized, will have an impact on family          outcomes measured as well-being, adaptation, and caregiver/family quality of life.        2. Variables influencing perception of stress and variables influencing family coping will          be significant predictors of family adaptation outcomes.        3. Perceptions of stress, coping skills utilized, and family adaptation outcomes will          improve during the first 14 months of life with an infant with HLHS.        4. Mothers and fathers will report different perceptions of stress, coping skills utilized,          and family adaptation outcomes during the first 14 months of life with an infant with          HLHS.   "
220795|NCT00734656|"     This study will explore the hypothesis that effects of alcohol are in part mediated by     increased production of neuroactive steroids, which interact with GABAA-receptors. We propose     to study non-dependent drinkers using a 4-session within-subjects design in which alcohol /     placebo is paired with dutasteride / placebo pretreatment. Dutasteride is a 5-alpha steroid     reductase (5AR) inhibitor that limits the production of dihydrotestosterone and the     5a-reduced neuroactive steroids allopregnanolone, pregnanolone and 3a,5a-androstanediol.   "
220796|NCT00734669|"     The aim of this study is to establish the risk and frequency of non-symptomatic hypoglycemia     in type 2 diabetes under previous therapy with glibenclamide. Participants will be monitored     via a continuous glucose monitoring system in a standardized clinical setting during day and     night time, implementing meals and exercise of moderate intensity performed in the     postprandial state.   "
220797|NCT00734682|"     This is a Phase I study of Nanoliposomal CPT-11 in patients with Recurrent high-grade     gliomas. Patients must have a histologically proven intracranial malignant glioma, which     includes glioblastoma multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA),     anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant     astrocytoma NOS (not otherwise specified). Patients who are wild type or heterozygous for the     UGT1A1*28 gene will received Nanoliposomal CPT-11. The total anticipated accrual will be     approximately 36 patients (depending upon the actual MTD). The investigators hypothesis is     that this new formulation of CPT-11 will increase survival over that seen in historical     controls who have recurrent gliomas because CPT-11 will be encapsulated in a liposome     nanoparticle, which has been seen to reduce toxicities from the drug.   "
220798|NCT00734695|"     Eye burns may cause a severe permanent damage. One kind of treatment is the use of vitamin C     (Ascorbic acid). This study will compare between subconjunctival topical and/or systemic     route of administration and topical and/or systemic administration.   "
220799|NCT00734708|"     This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast     growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to     evaluate the safety of such stimulation.   "
220800|NCT00734721|"     1. Intravitreal injection can induce perioperative stress for the patients.        2. Different factors can modulate the pre-operative fear and physiologic reaction.   "
220801|NCT00734734|"     Trial for annual approval of interpandemic influenza vaccines   "
220802|NCT00734747|"     The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling     system for the treatment of GERD.      The system allows the operator to staple the stomach to the esophagus,in order to restore the     gastroesophageal flap valve. The effect of the stapling is similar to a common operation for     GERD (partial fundoplication) but is done through the mouth, and incision into the abdomen is     not needed.      The hypothesis of the study is that the treatment will be effective in improving GERD related     quality of life by 50% or more in the majority of the subjects, and that the procedure will     be as safe as surgery.   "
220803|NCT00734760|"     This study was conducted to test whether a focused education and counseling intervention     delivered by a nurse will decrease time of delay in seeking treatment for the signs and     symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as     having ischemic heart disease.   "
220804|NCT00743145|"     The purpose of this study is to determine how naltrexone shifts the marijuana-response curve,     a single, low-dose of naltrexone (12 mg/70 kg) or placebo will be administered 45 minutes     before smoking marijuana (0,2,4,6,puffs of 6.2% THC). Naltrexone (12 mg/70 kg) or placebo     will be administered 45 minutes before smoking to assess how opioid receptor blockade affects     marijuana's subjective and physiologic effects. It is predicted that increasing the number of     puffs of active marijuana will increase positive subjective ratings of marijuana and     naltrexone and further increase these ratings.   "
220805|NCT00743158|"     This study aims to determine whether respiratory system transfer impedance (Ztr) may fill an     important clinical function by providing a reproducible, valid, and sensitive measure of     airway obstruction in people with CF.   "
220806|NCT00743171|"     Prospective cohort, mono-center study included electronic data of home spirometry (HS, lung     function) of lung transplant recipients   "
220807|NCT00743184|"     This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the     efficacy of ozarelix compared to placebo in the treatment of lower urinary tract symptoms     (LUTS) secondary to benign prostatic hyperplasia (BPH) in men as assessed by the     International Prostate Symptom Score (IPSS) at Week 14.   "
220810|NCT00743223|"     The aim of this study was to verify the frequency of the forward head posture in subjects     with temporomandibular disorder and to compare them with control group   "
223331|NCT00774020|"     The purpose of this study is to document the efficacy and safety profiles of single     intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone     (PDB).   "
220815|NCT00743288|"     RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing.     Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Giving melphalan together with panobinostat may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan when     given together with panobinostat in treating patients with recurrent multiple myeloma.   "
220816|NCT00743301|"     The aim of this study is to compare the effects of a diet rich in palm olein, a fraction of     palm oil, to a diet rich in olive oil and a diet rich in Danish lard on plasma total-, LDL     and HDL cholesterol as well as triacylglycerol (TAG), fasting insulin and glucose, C reactive     protein and plasminogen activator inhibitor 1 in healthy men. The investigators hypothesis is     that palm olein and olive oil will have the same effect on plasma total cholesterol, LDL- and     HDL concentration and maybe also on the secondary outcome parameters that are related to     cardiovascular disease risk. This may be caused by the differences in the sn-positioning of     palmitic acid in palm olein. This difference may cause the palmitic acid in palm olein to be     more prone to soap formations and excretion than palmitic acid from other sources, e.g. lard.      This study is a double blinded, randomized, controlled 3 x 3 week crossover intervention     study, without washout periods. The participants receive the three test foods in random     order, decided by draw of lots. Blood samples are drawn in duplicate (on two following days)     before and after each dietary period.   "
220817|NCT00743314|"     RATIONALE: Diagnostic procedures, such as single-photon emission computed tomography and     computed tomography lymphoscintigraphy, may help lower the dose of radiation therapy after     surgery, and help prevent lymphedema.      PURPOSE: This clinical trial is studying single-photon emission computed tomography and     computed tomography lymphoscintigraphy followed by intensity-modulated radiation therapy to     see how well they work in treating patients who have undergone surgery for stage I or stage     II breast cancer.   "
220818|NCT00743327|"     The purpose of this study is to examine the link between low testosterone and insulin     resistance/diabetes in men undergoing androgen deprivation therapy for prostate cancer. The     study will also evaluate other cardiovascular risk factors in these men.   "
220819|NCT00743340|"     The purpose of this study is to provide current FTC-203 study participants in South Africa     with continued access to the study drug, emtricitabine, following completion of the FTC-203     study. Individuals participating in this rollover protocol will receive emtricitabine, for as     long as they continue to meet specific virologic criteria and until they withdraw from study,     experiences a toxicity that necessitates the permanent discontinuation of emtricitabine, or     emtricitabine is approved in the country of residence.   "
220820|NCT00743353|"     The purpose of this research study is to get information from volunteers without cancer and     patients with cancer who have received a new investigational study agent called, [F-18]     RGDK5, to evaluate biodistribution and dosimetry for the study agent and determine F-18     RGD-K5 uptake in angiogenic tumor. the system.   "
220821|NCT00743366|"     The objective of this study is to investigate the interaction between marijuana and     quetiapine, with the goal of using this information to improve marijuana treatment outcome.   "
220822|NCT00743379|"     The purpose of this study is to determine if TH-302, in combination with A) Gemcitabine, or     B) Docetaxel or C) Pemetrexed methotrexate, are safe and effective in the treatment of     Pancreatic Cancer, Castrate-resistant Prostate Cancer, and Non-small Cell Lung Cancer,     respectively.   "
220823|NCT00743392|"     The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year     old women who report having used internet dating websites in the past year.   "
220824|NCT00743405|"     This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics     of single doses of GSK1034702 in healthy subjects. It will be a single-blind, randomized,     placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and     female (of non-child bearing potential) subjects. Subjects will be randomized into cohorts of     10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits     are reached. Each subject will receive placebo and up to 4 doses of GSK1034702 in a     randomized sequence on 5 separate study occasions.   "
220906|NCT00746317|"     This phase I trial is studying the safety and best dose of GC33 in patients with advanced or     metastatic liver cancer.   "
220909|NCT00746356|"     This study is a prospective, non-randomized, multi-center clinical trial that will assess the     safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF     ICD devices. These new ICD and CRT-D devices have new features that allow the device to     periodically check how much energy is needed to pace a patient's heart and to automatically     adjust the amount of energy used to pace the heart.   "
220825|NCT00743418|"     The research is aimed at exploring the application of novel tracking technique for the study     of spatial activity among dementia patients and its implication on their families. The study     sample will be composed of three groups of volunteers, each including100 participants aged     over 60 years. The first group will include MCI (Mild Cognitive Impairment) patients. The     second group will include patients that suffer from mild dementia. The third group will     include age matched healthy participants. The tracking equipment will be a GPS apparatus of     450 gms that will be carried by the participants for 24 hours along 2-4 weeks. The GPS data     will be transferred via the cellular network to operator center at the Hebrew university at     Jerusalem, and will be documented in assigned data files. This monitoring procedure will be     held every year and along a period of five years. The impact of the patient behavior on the     care giver will be studied by means of five interviews along the tracking period.   "
220826|NCT00743431|"     The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with     advanced ovarian cancer, focusing on infusion reactions and palmar-plantar     erythrodysesthesia.   "
220827|NCT00743444|"     The purpose of the study is to compare frequency and content of reflux episodes in patients     with gastroesophageal reflux disease.   "
220828|NCT00743457|"     The purpose of the study is to determine whether an ultrasound of the eye can be used as a     radiation-free alternative to X-ray to identify children with risk of shunt failure in the     Emergency Department. Please note that a shunt is an artificial or natural channel running     between two other channels.2. Briefly summarize how participants are recruited.   "
220831|NCT00745329|"     Background: The treatment of inflammatory bowel diseases (IBD) is based mainly on 3     compounds: 1- 5 aminosalysilates . 2- immunomodulators (Azathioprines). 3- Biologic therapies     (Infliximab, Adalimumab) . There are no established data in the literature whether these     therapies effects sperm quality. Given that a large number of the patients are young men in     the reproductive stage of their lives , It of importance to investigate these effect.      Aim: To investigate the effect of chronic treatment of any of the three therapy mentioned     above, on sperm quality .   "
220832|NCT00745342|"     This 2-year randomized, controlled trial examined the impact of a clinic-based, family     teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.   "
220833|NCT00745355|"     The purpose of this study is to learn about the quality of life of people living with bladder     cancer. We are interested in learning about how the treatments for bladder cancer affect     people. We plan to use the findings from this study to help doctors provide better care and     information to patients with bladder cancer.   "
220834|NCT00745368|"     The purpose of this research study is to determine how much raltegravir gets into the male     and female genital tract.   "
220835|NCT00745381|"     The purpose of this study is to establish a neuroendocrine tumor registry. A registry is a     collection of information. To create this registry, the investigators would like to get     information, blood and tumor samples from people with neuroendocrine tumors. By collecting     this information and material, the investigators are hoping to learn more about the genetic     causes of neuroendocrine tumors. All of this will help us to better understand neuroendocrine     cancer, so the investigators can find better ways to treat and diagnose this disease. DNA     will be taken from the blood samples and will be used in future studies. This will be an     important resource from which the investigators can study genes that may be related to a     higher risk of neuroendocrine tumors.      The information collected will include medical information, family history of cancer and your     answers to questions about how the cancer affects quality of life.   "
220836|NCT00745394|"     Non-invasive assessment of blood flow to organs has long challenged clinicians. Recently,     near infrared spectroscopy (NIRS) has been recognized as a methodology that may achieve this     goal. A commercially available NIRS monitor, marketed by Somanetics, Inc., is now in     widespread use in the clinical care of pediatric cardiac patients in the operating room and     in the intensive care unit post-operatively. When a patch/probe from the monitor is placed on     the forehead or lower back, blood oxygen concentration data is obtained which has been found     to correlate with actual blood samples taken by IV. The presence of this NIRS data would give     the surgeon important feedback about blood flow to important areas like the brain and kidneys     during heart surgeries on children and after the operation is completed in the intensive care     unit.      The investigator wishes to perform a prospective study of the NIRS monitor use with children     that need heart surgeries that require heart-lung bypass and sometimes require monitoring in     the ICU, post-operatively.   "
220837|NCT00745407|"     Fenofibrate increases adiponectin levels, but reduces leptin levels   "
220838|NCT00745420|"     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease     that can cause organ damage, stroke, and intense pain episodes. A blood stem cell transplant     is a treatment option for someone with a severe form of the disease. Prior to undergoing a     transplant, people typically receive a conditioning regimen of high doses of chemotherapy and     other medications to prepare the body to accept the transplant. A conditioning regimen that     uses lower doses of chemotherapy and medications may be safer for transplant recipients. This     study will evaluate the safety and effectiveness of blood stem cell transplants, using bone     marrow from unrelated donors, in children with severe SCD who receive a reduced intensity     conditioning regimen prior to the transplant.   "
220839|NCT00745433|"     This study is conducted in Europe. The aim of this observational study is to investigate the     efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding     repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical     practice   "
220840|NCT00745446|"     The purpose of this study is to determine whether a retrofit particle trap can reduce the     adverse vascular responses to diesel exhaust inhalation   "
220841|NCT00745459|"     Patients who require gastric endoscopy, including the patient population* excluded from the     phase III controlled clinical study of NPO-11, will receive an intragastric single dose of     NPO-11 20 mL. The efficacy of NPO-11 as a premedication for endoscopy will be evaluated based     on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and     the end of endoscopy (primary outcome measure).      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions     (ADRs) observed between administration and seven days after administration.      Patient population excluded from the phase III controlled clinical study of NPO-11        -  Patients with reflux esophagitis        -  Patients with active gastric or duodenal ulcers        -  Patients who undergo endoscopy under sedation        -  Patients who undergo endoscopy with a scope of <9 mm in diameter   "
220842|NCT00745472|"     Monitoring of auditory evoked potentials (AEP) in patients during general anaesthesia is     commonly used to ensure a sufficient hypnotic level during surgery. The amplitude of AEP     (AEPa) has in clinical settings been found to correlate to pain. The aim of the study was to     test, if AEPa could detect increasing experimental pain stimulations in healthy volunteers.     Electric nerve stimulation, cold and heat pain were used as pain models.   "
220843|NCT00745485|"     1. The study will assess the safety and tolerability of a single-infusion of zoledronic          acid 5 mg administered in a private medical practice setting by a nurse provided by a          nationwide infusion service. Safety data will largely be monitored by investigating          changes in the patients' well-being during the study.        2. The study will pilot and test a Patient Registry and Infusion Service process, which          will allow zoledronic acid to be administered to trial patients in the investigators'          private rooms by a team of roving nurses.   "
220844|NCT00745498|"     The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab     injection on postoperative vitreous hemorrhage after diabetic vitrectomy.   "
220845|NCT00745511|"     This is s randomized, multi-center, double blind, 3 arm, phase I/II pilot study to evaluate     the safety and efficacy of treatment with ORA102 combined with Avastin (Bevacizumab) versus     Avastin alone, in patients with neo-vascular age related macular degeneration (AMD).   "
220846|NCT00745524|"     This study aims to investigate the prevalence of ADHD and other psychopathology, and current     function and life quality among several high risk populations of imprisoned adults and     adolescents who receive special resources in school or dropout from school.   "
220847|NCT00745537|"     Postpartum depression (PPD) is depression that occurs shortly after the mother delivers her     baby. Mothers with postpartum depression may feel sad mood, low motivation or stress; some     may have problems caring for their new baby. Successful depression treatment involves early     screening and detection of postpartum depression and early access to treatment services.      The purpose of this study is to evaluate the effectiveness of a telephone-based depression     screening and care management program for postpartum women. We will evaluate the: 1) how     often (frequency) young mothers develop symptoms of depression 4 to 6 weeks after birth, 2)     how quickly (timeliness) young mother receive treatment and how effective (adequacy) are the     treatments for the symptoms of postpartum depression, 3) the effects of depression care     support on young mothers' symptoms and their ability to function at 3, 6 and 12 months after     entering the study, 4) visits to the pediatrician or nurse practitioner (preventive health     services) during their baby's first year of life, and 5) cost and cost savings associated     with depression care management.   "
220848|NCT00745550|"     The study consists of two phases: The first portion of the study is a Phase 1 dose escalation     study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when     given as a single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis     (CIMF) regardless of their JAK2 mutational status. The second portion of the study is a Phase     2 study to define the efficacy and safety profile of single agent SB1518 at the recommended     dose in subjects with CIMF.   "
220849|NCT00745563|"     A couple that does not achieve pregnancy though regular attempts for a year are defined     infertile couple. This condition is caused by faulty functioning of the reproduction system     of the husband or wife or both. If there are no organic defects and there is no definite     injury to the reproductive system (ova or spermatozoa), the specialist doctor generally     decides to put the couple into a fertility treatment program. Artificial insemination is one     of the important ways of achieving pregnancy.      Three common methods of artificial insemination:        1. Placement of a diaphragm that contains raw spermatozoa or isolated improved spermatozoa          in an appropriate liquid solution (Cup insemination, CI) upon the cervix.        2. Spermatozoa injection (after improvement) through the vagina to the cervix          (Intra-Cervical Insemination, ICI).        3. Spermatozoa injection (after improvement) directly into the uterus (IUI-Intra-Uterine          Insemination).      The EVIE - Slow Release Insemination method:      The slow release insemination is utilizing a Grasby type MS16 pump for 3 hours. The release     rate for motile spermatozoa is 50X103 per minute.      Advantages:        -  Very close approximation of the natural procedure in which the spermatozoa arrive to the          fertilization site over a long period.        -  An extended window of opportunities for meeting between the ovum and spermatozoa will          be longer.        -  There is no loss of spermatozoa due to leaking as sometimes happens with single-time          injection practiced in the IUI method.      Primary Endpoint:      Accumulation of 50 cycles of SRI- slow release insemination (study group) in addition to 50     cycles of regular IUI (control group). Two weeks after insemination Beta hCG test      Secondary Endpoints:      Four weeks after insemination - US Viability scan      Procedure:      Subjects will be women with fertility difficulties who are designated for IUI treatment. 100     insemination cycles will be conducted. (50 regular IUI and 50 EVIE-SRI). Subjects that were     treated with the IUI method and who does not become pregnant will then be treated with the     EVIE-Slow Release method and vice versa.   "
220850|NCT00745576|"     The purpose of this study is to evaluate the effects of multiple doses of verapamil on the     plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to     assess the safety and tolerability of co-administration of SAM-531 and verapamil.   "
220851|NCT00745589|"     To test the hypothesis that second-line fixed low-dose sevelamer hydrochloride therapy is as     effective as first-line high-dose sevelamer hydrochloride therapy in limiting the progression     of cardiovascular calcification.   "
220852|NCT00745602|"     The proposed research will investigate whether the irregular effects of atrial fibrillation     on the body's circulation directly impacts the regulation of cerebral blood flow. To further     delineate this finding, investigation of these potential effects will include differences in     postural positioning. This data will be used to further understand the overall hemodynamic     effects of atrial fibrillation on extra-cardiac organs of the body.   "
220910|NCT00746369|"     The IMARA Program will test the efficacy of a multi-session HIV Prevention program, adapted     from an existing program(SiHLE), for incarcerated African American adolescent females.   "
221325|NCT00749996|"     The study aims at assessing the short and long-term effectiveness and patient perception of     benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc     disease at a single level from L2 to L5.   "
220853|NCT00745615|"     This is a continuation of the LAQ/5063 study which was a multinational, multicenter,     randomized, double-blind, parallel group study, assessing the safety, tolerability and     efficacy of two doses of laquinimod in subjects with R-R MS followed by an open label phase     of laquinimod 0.6 mg daily (LAQ/5063 OL).      Subjects entering this randomized, two active arms study immediately after completion of the     LAQ/5062 core study.      Subjects entering the open-label phase (LAQ/5063 OL) upon the termination visit of LAQ/5063     active double-blind phase      Subjects previously treated with placebo in the LAQ/5062 study are equally randomized to one     of the active treatment groups:      0.6 mg of laquinimod per os (p.o.) once daily 0.3 mg of laquinimod p.o. once daily Subjects     previously treated with laquinimod 0.6 mg or laquinimod 0.3 mg continuing on their original     treatment assignment.      The LAQ/5063 study assessed the 0.3mg and the 0.6mg daily doses of laquinimod in patients who     completed the LAQ/5062 study.      Upon the termination visit of LAQ/5063 active double-blind phase (completion of the full 36     weeks or as requested by the Sponsor) and after meeting the eligibility criteria of the     open-label phase, all subjects began treatment with laquinimod 0.6 mg once daily for 24     months In the current phase, this open-label extension is further extended in additional 36     months of treatment with laquinimod 0.6mg once daily.   "
220854|NCT00745628|"     Construction of coronary heart disease cohort of more than 10000 patients in China.     Investigation on current situation of secondary prevention of CHD will be carried out and the     effect of physician training and patient education will be evaluated.   "
220866|NCT00745784|"     The purpose of the research is to learn more about the experience of grief in young bereaved     spouses/partners. Recent research has shown that young bereaved spouses/partners experience     grief uniquely from other age groups, but it is still unclear how certain factors affect the     experience of grief. The investigators research team is interested in studying how the     psychological factors of trauma, personality, and meaning of the loss affect grief reactions     in young spouses/partners after the loss of a spouse to cancer.   "
226646|NCT00819065|"     The purpose of this study is to compare the effectiveness between two commercial formulations     of botulinum toxin type A in the treatment of spasticity through the Ashworth scale.   "
220855|NCT00745641|"     The clinically widely used X-ray computed tomography examination has a low-grade radiation     effect and recently has attracted much attention concerning the possible adverse effects of     radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells     mainly because it can interact with water (which makes up to 80% of cells) to generate     reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we     can reach, there is no report concerning the relation between X-ray computed tomography     examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if     the routinely applied abdominal X-ray computed tomography examination may induce a higher     level of ROS in the peripheral blood.      Study subjects will be patients who are admitted to our hospital because of abdominal     diseases that need to receive abdominal X-ray computed tomography examination for diagnosis.     In total, sixty cases will be enrolled for the study. The formal consent will be delivered     and explained to the patients and families several hours before the performance of abdominal     X-ray computed tomography. The formal consent will be retrieved and then the peripheral blood     will be sampled just before the performance of computed tomography.ROS level in the sampled     peripheral blood, before and after the performance of abdominal X-ray computed tomography,     will be measured, compared, and analyzed. Totally 120 blood samples, including 60 samples     just before and 60 samples 2 hours after the performance of computed tomography, will be     collected from 60 study subjects within 5 months (August 10 ~ December 30, 2008). Reactive     oxygen species（ROS）levels will be measured by a chemiluminescence (CL) analysing system     (CLD-110, Tohoku Electronic Industrial, Sendai, Japan).   "
220856|NCT00745654|"     This is an investigation on the frequency of chronic pain amongst recipients after lung     transplantation. Factors relating to the development of chronic pain are investigated.   "
220857|NCT00745667|"     This is a multicenter trial comparing laparoscopic correction of a perforated peptic ulcer     with the open technique by upper laparotomy. Hypothesis is that after laparoscopic correction     will be discharged 3 days sooner due to less postoperative pain and complications.   "
220858|NCT00745680|"     Left ventricular (LV) remodeling after acute myocardial infarction (AMI) has been well     described in previous studies. However, there is a paucity of data on the incidence of and     risk factors for LV remodeling in modern clinical practice that incorporates widespread use     of acute reperfusion strategies and almost systematic use of antiremodeling medications,     such as angiotensin-converting enzyme inhibitors and beta blockers. The recent improvements     in AMI management do not abolish LV remodeling, which remains a relatively frequent event     after an initial anterior wall AMI. As a leading cause of heart failure, postinfarction LV     remodeling represents an important target for therapeutic interventions. Within the     ventricular mass, size, shape, connections and orientation in a three-dimensional space of     every single constituent determine its functional behavior. The complex architecture of the     ventricular mass creates multiple inhomogeneities of electrical and mechanical loads at the     cellular and the microscopic tissue level, that cause cardiac function to be 'stochastic in     nature'. The myocardial infarction will altered the ventricular shape and functional     inhomogeneities carrying the morphodynamic advantages such as impaired suction for diastole     after diminishing recoil relaxation with decreased twisting strain in systole. The alteration     in contractile mechanics interacts with the intraventricular fluid dynamic filed that     influence the regional myocardial shearing stress. Altered LV transmural wall strains have     been proposed to cause infarct extension and may have an important role in propagating LV     remodeling.   "
220859|NCT00745693|"     The purpose of this study is to identify the role of endothelin 1 (a natural vasoconstrictor)     in the adverse vascular effects demonstrated after exposure to air pollution   "
220860|NCT00745706|"     Atrial Fibrillation (AF) is a common heart rhythm problem that can be eliminated by a     radiofrequency ablation procedure. The purpose of this study is to assess the amount of AF     that occurs before and after an ablation procedure associated with symptoms versus AF that is     not associated with any symptoms. This study will confirm whether patients' symptoms or lack     of symptoms post-ablation correlate well with actual episodes of Atrial Fibrillation. This is     important information for physicians to know as it will help guide patient care post-ablation     in the future. Information on patients' AF episodes will be collected by an implantable loop     recorder (ILR) which will be implanted in all study patients 3 months prior to their AF     ablation procedure. The ILR will automatically collect information on detected AF episodes     while patients will records any symptoms related to AF episodes in study diaries.   "
220861|NCT00745719|"     To test the hypothesis that total parathyroidectomy retards cardiovascular calcification,     improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in     end-stage renal disease patients on maintenance dialysis.   "
220924|NCT00746551|"     The purpose of this study is to compare the efficacy of body iron storage replenishment     between low dose intravenous iron and oral iron in late pregnancy.   "
220862|NCT00745732|"     Primary Objectives:        -  To assess the safety of oral therapy with ZD6474 by evaluating the frequency, severity,          and duration of treatment-emergent adverse events in patients with poor prognosis lung          cancer.        -  To record the extent, frequency and duration of any tumor responses to this treatment          regimen and assess whether ZD6474 augments the efficacy of radiation therapy in          non-small cell lung cancer patients.        -  To determine the recommended phase II dose of ZD6474 for future clinical studies with          radiation therapy.      Secondary Objectives:        -  To determine the effects on metabolism and angiogenic factors by positron emission          tomography (PET) scan/computed tomography (CT) scan , vascular endothelial growth factor          (VEGF), and circulating endothelial cell levels in patients treated with ZD6474 and          radiation therapy.   "
220863|NCT00745745|"     This clinical trial is a multi center, prospective, randomized, parallel study designed to     compare septal to apical ICD lead placement.   "
220864|NCT00745758|"     Extensive research has shown that the big event that leads to the initiation of vasospasm is     the release of oxyhemoglobin (blood breakdown product).Depletion of NO synthase (19,20,21)     was also noted after SAH.CSF is produced from choroid plexus in the ventricle. If the SAH is     too dense, the blood in the subarachnoid space will not easy to be washed out.   "
220865|NCT00745771|"     Multiple-dose, double-blind, double-dummy, parallel, randomized, placebo and active     controlled study of pharmacokinetics of Diractin® as well as safety and efficacy for muscle     soreness from exercise.   "
220867|NCT00745797|"     1. Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy,          were randomized to receive PCI (30 Gy/10fr) or no PCI.        2. The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .        3. The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5%          significance (60 events, 206 patients).   "
220868|NCT00745810|"     Ischemia- reperfusion ( IR ) injuries were not only seen in the transplanted organs but also     the remote organs such as lungs that brings major postoperative complications. Severe     complications such as pulmonary infiltration and pulmonary edema following reperfusion were     frequently associated with liver transplantation. Cardiac surgery performed with the use of     cardiopulmonary bypass ( CPB ) provokes a systemic inflammatory response syndrome that     affects postoperative pulmonary, myocardiac and renal functions. Previous study about the     reperfusion injuries was focused on the leukocyte and endothelial activation and the     following oxidative injuries, however, the alteration on pulmonary function such as dynamic     compliance and the oxidative/antioxidative balance in erythrocytes and the following effects     in CPB have not been fully studied. Erythrocytes' reaction to oxidative stress including     cytoplasma and cell membrane should be studied because RBCs are the major circulating blood     cells having different types of antioxidant system to capture reactive oxygen species ( ROS )     thus RBC may be severely injured by ROS or protected ROS injuries during CPB. In these     three-year study, we plan to explore the extent and pattern of remote oxidative injuries in     lungs by massive ROS production and the following products released from reperfused organs.     In the first year, the remote pulmonary injuries from hepatic IR will be focused. We plan to     establish an animal model for pulmonary function and pulmonary injury assessments including     dynamic compliance (Cdyn), pulmonary edema wet-to-dry ratio (W/D), malondialdehyde (MDA) and     histopathological findings under hepatic IR challenge. In the second year, the IR effects     during and after CPB on circulating blood cells will be fully studied. We plan to investigate     the magnitude, subtypes and timing on ROS production, the changes of oxidative and     antioxidant activities of erythrocytes including cytoplasma and cell membrane, the changes on     leukocytes and plasma to explore the roles of circulating erythrocytes on oxidative stress in     CPB. In the third year, we plan to try propofol, stated having antioxidant in vivo and in     vitro, on the remote pulmonary injuries following hepatic IR and CPB.   "
220869|NCT00745823|"     A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared     to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve     human immunodeficiency virus (HIV)-infected patients.   "
220870|NCT00745836|"     High dose atorvastatin may worsen insulin sensitivity.   "
220871|NCT00745849|"     The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in     treating non-allergic rhinitis   "
220872|NCT00745862|"     The purpose of this study is to examine the experiences and quality of life of women who have     been treated for melanoma. By quality of life, we mean how they are feeling about different     aspects of their life. In this study, we are especially interested in their feelings about     survival, physical appearance and any family concerns. We will administer a series of QOL     questionnaires, data sheets with many questions, to get their response to measure their     feelings about these issues.   "
220873|NCT00745875|"     The aim of this study is to collect initial efficacy and safety data on the use of a new     treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard     chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment     with pemetrexed alone   "
220874|NCT00745888|"     In clinical practice, the oxidative stress is related to circulatory shock, sepsis, acute     lung injury, and acute respiratory distress syndrome. There are some questions on the     oxidative stress of the critical illness. First, the investigators want to search out the     effects of the past history, smoking, alcohol drinking, use of antioxidants, different     diseases, and different duration of SIRS on the degree of oxidative stress. Second, besides     total count of ROS, the investigators used new techniques to determine superoxide(O2●-),     hydrogen peroxide (H2O2), and hypochlorous acid(HOCl). Furthermore, we want to investigate     the correlation of the degree of different reactive oxygen species and the severity of SIRS     or shock. Third, we try to investigate the correlation between the change of oxidative stress     and the prognosis of the patients.      The investigators wish this study will help them to investigate the effect of oxidative     stress on critical ill patients, to modulate the oxidative stress, to decrease the occurrence     of SIRS, shock, and multiorgan failure, and to improve the long term outcome of patients.   "
220875|NCT00745901|"     The purpose of this study in healthy sexually active females is to evaluate the cycle control     with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.   "
220876|NCT00745914|"     To test the hypothesis that PPAR-gamma agonist, rosiglitazone, induces carotid plaque     regression in diabetic ESRD patients on maintenance PD via its anti-inflammatory property.   "
220925|NCT00746564|"     The goal of this IDE clinical study is to evaluate the quality of the cardiac signal     recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor     (device).   "
220877|NCT00745927|"     It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and     abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy     even under sedation has been already assessed in some earlier trials. Air insufflation is     still the standard method, however, because of a lack of suitable equipment and continued     technical improvement in colonoscopy.      In laparoscopic surgery, CO2 insufflation is widely applied and safely used with the patient     under general anesthesia. CO2 insufflation is also applied for CT colonography for reduction     of discomfort during or after procedure.2 During endoscopic procedure for colorectal     neoplasia resection, however, long procedural time may increase not only the degree of     discomfort during and after the procedure but also the risk of perforation. In addition to     laparoscopic surgery, CO2 insufflation has also been applied to other endoscopic procedures.     Saito et al reported the application of CO2 insufflation in Endoscopic submucosal dissection     (ESD) of colorectal neoplasia in a prospective study in which their average procedural time     using CO2 insufflation was 90 minutes under conscious sedation with average of 5.6 mg of     midazolam. When compared with control group using room air, statistically negligible     difference of pCO2 was observed with significant difference in abdominal discomfort.6     Screening colonoscopy, which can be completed within 15 minutes if no lesion being detected,     requires high screenee satisfaction so as to improve patient compliance. In the setting of     colonoscopy after positive FOBT, the attendance rate for secondary colonoscopy was around 60     to 70 % according to the data demonstrated in previous RCT and population-based studies. With     application of CO2 insufflation, further improvement of patient compliance can be     anticipated.      This study aims to investigate whether use of CO2 insufflations can reduce examinee     discomfort in comparison with air.   "
220878|NCT00745940|"     The purpose of this study is to determine whether mindfulness-based cognitive therapy is     effective in reducing depression symptoms in individuals who have experienced a traumatic     brain injury.      The investigators hypothesize that participants who are given the ten-week intervention will     have fewer depression symptoms than the participants in the control group, and this     improvement will be maintained at the three-month follow-up assessment.   "
220895|NCT00746174|"     This study will include subjects with an abnormal glucose tolerance test. Using a crossover     design, we will evaluate the insulin sensitivity and intracellular lipid content of the     heart, liver and skeletal muscle of subjects before and after therapy with Rosiglitazone and     placebo. We hypothesize that Rosiglitazone will improve insulin sensitivity in association     with reduced muscle lipid content that may arise either from increased lipid oxidation or     enhanced storage of fat in adipose tissue.   "
220879|NCT00745953|"     Traditionally, obesity is considered an indirect cause of heart disease. Obese individuals     typically present with a number of traditional Framingham risk factors (hypertension,     dyslipidemia, and type 2 diabetes), predisposing them to heart attacks and subsequent heart     failure. However, an emerging body of basic research revisits a hypothesis that fat is a     direct cardiotoxin. Under healthy conditions, most triglyceride is stored in fatty tissue     (adipocytes) while the amount of triglyceride stored in non-adipocyte tissues (such as the     pancreas, the liver, skeletal muscle, and heart) is minimal and very tightly regulated. When     this regulation is disrupted, intracellular triglyceride accumulates excessively in these     organs (steatosis) and has been implicated in activating adverse pathways which culminate     in irreversible cell death (lipotoxicity), leading to several well-recognized clinical     syndromes. These include non-alcoholic steatohepatitis (NASH), pancreatic beta-cell failure     in type 2 diabetes, and dilated cardiomyopathy.      It has been recently observed that angiotensin II receptor blockers (ARBs) in addition to     lowering blood pressure improve insulin sensitivity and decrease the risk for type 2     diabetes. This study will test the above theory in two study groups: Valsartan vs.     Hydrochlorothiazide. We hypothesize that in obese humans with elevated myocardial     triglycerides, blockade of the renin-angiotensin system (Valsartan group) will reduce     myocardial fat with improvement of insulin sensitivity and heart function.   "
220880|NCT00745966|"     The purpose of this study is to reassure the clinical study data on atypical antipsychotics     effect on quality of life in Korean Bipolar patients.   "
220881|NCT00745992|"     Voriconazole is an effective antifungal agent and may decrease morbidity and mortality for     patients with invasive fungal infections. It is metabolized via liver enzymes. However, these     enzymes exhibit different activities in individual patient (genetic polymorphism). Higher     proportions of Asians metabolize voriconazole slower than Caucasians and African Americans     do. Slower metabolizers may experience dose-associated adverse events more frequently, such     as visual disturbances, liver function test abnormalities, and neurological complications. On     the other hand, extensive metabolizer or other physiologic conditions may lead to lower blood     levels of voriconazole, which may result in treatment failure.      We plan to enroll patient who take voriconazole and examine their liver enzyme activities and     blood samples for peak and trough drug levels. We will collect potential factors affecting     voriconazole levels, and correlate the levels with the dosing regimen, activity of liver     enzyme, occurrence of adverse events, and treatment outcomes. The goal of this study is to     determine if monitoring of voriconazole blood levels is necessary in Taiwan.   "
220882|NCT00746005|"     To study the short term effects of a pharmacological dose of fish oil on cognitive     performance and on cerebral blood flow. Furthermore, we want to investigate whether carriers     of the APOEε4 allele respond differently to fish oil treatment compared to non-carriers.   "
220883|NCT00746018|"     Some patients, specifically those with a diagnosed genetic mutation, will have their ovaries     and fallopian tubes removed without removal of the uterus in an attempt to prevent ovarian     and fallopian tube cancer from developing.      Anatomically the fallopian tubes are attached to the uterus and extend towards the ovaries.     The fallopian tube tissue arises within the corner area of the uterus and occupies about 1cm     of the uterine muscle wall.      The purpose of this study is to determine if the technique used to remove fallopian tubes     only (without removal of the uterus) adequately removes or destroys all the fallopian tube     cells that remain in the uterine muscle wall.      Currently, during the operation an instrument is used that burns the fallopian tube and     allows it to be cut away from the uterus. The investigators do not know if this procedure     successfully destroys all the fallopian tube cells within the uterus. Therefore, we will     compare this single step procedure to a two step procedure. The two step procedure is to burn     and cut the fallopian tube followed by an additional burning step, called cauterization at     the top of the uterus. The investigators will assess if either or both of these procedures     destroy the fallopian tube cells that may remain inside the uterine wall. This is important     to determine since the goal is to remove the ovaries and all of the fallopian tubes in order     to prevent future development of ovarian or fallopian tube cancer.   "
220907|NCT00746330|"     This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and     duration of action), of a single dose of formoterol fumarate in combination with mometasone     furoate to placebo in children of 5-11 years with persistent asthma. The study will also     assess the bronchodilatory effect of a single dose of formoterol fumarate alone and in     combination with mometasone furoate delivered via a pressurized metered dose inhaler (pMDI)     to the bronchodilatory effect of formoterol fumarate delivered via a dry powder inhaler     (DPI). Furthermore, pharmacokinetic assessments of plasma and urine will also be conducted     throughout the study to assess systemic exposure following administration of the study     medication.   "
223332|NCT00774033|"     The aim of the study is to compare results obtained with epidermal cell spray and classic     skin grafting for epidermal replacement in acute burns   "
220884|NCT00746031|"     Fibroids are present in up to 80% of women of reproductive age. Associated heavy menstrual     bleeding is often an indication for surgery. At present there are no long-term medical     treatments for fibroids. There is an unmet need for a pharmacologic agent able to reduce     excessive bleeding and other symptoms associated with increased uterine volume, which could     prevent or significantly delay surgery without causing significant unwanted hypoestrogenic     side effects and allow preservation of fertility.      The purpose of this study is to investigate and validate novel MR imaging as a non-invasive     biomarker for monitoring responses to medical interventions aimed at reduction of excessive     menstrual bleeding and decrease in uterine/ fibroid volume. MR imaging is non-invasive, does     not involve ionizing radiation and new techniques have the potential to resolve tissue detail     to near cellular level.      The investigators are aiming to establish the feasibility and reproducibility of novel MR     imaging techniques in the evaluation of treatment response in women with fibroids and to     provide mechanistic information on whether the reduction in blood flow of uterine/fibroid     vasculature in the shrinkage of fibroids is dependent upon subjects being hypoestrogenic.   "
220885|NCT00746044|"     Human Multidrug Related Protein 2 (MRP2) excretes several drugs and could therefore modulate     their elimination. Individual's MRP2 activity is under genetic control. Thus it would be very     useful to get an easily measurable biomarker reflecting individual's MRP2 activity. We aimed     to investigate the ratio of urinary coproporphyrins I and III (UCP(I/I+III), known to be     increased in patients with mutations in MRP2/ABCC2 gene.   "
220886|NCT00746057|"     The aim of the study is to explore the possibility to identify, at an early stage after a     renal graft and from blood samples collected within first months after graft, a predictive     transcriptional profile of long term occurence of graft operational tolerance or chronic     rejection.      The aim of the study is to determine an early transcriptional profile of chronic rejection in     the transcriptome of mononuclear blood cells. Validation and predictivity of transcriptional     analysis will be based on graft function and graft histology one year after     transplantation.The other aim is to determine an early transcriptional profile of operational     tolerance in the same patients using a DNA chip dedicated including two lists of genes     discriminating tolerant patients who are stopped immunosuppressant treatment for over a year.      To allow statistical analysis of 100 patients followed one year after graft, patients not     assessable at one year due to early termination of study will be replaced.   "
220887|NCT00746070|"     Primary aldosteronism (PA), characterized by an inappropriate production of aldosterone, is     far more common than is usually perceived. The overall prevalence of PA is 11.2% of the newly     diagnosed hypertensive patients and 4.8% was curable aldosterone producing adenoma (APA), and     adrenalectomy is considered the treatment of choice for APA. The potential curability and     prevention of excess cardiovascular damage and events also underscores the need to develop     accurate strategies for the timely diagnosis of APA.This study aimed to determine the effects     of endothelium function change ( PWV, progenitor cell,..) before and post-adrenalectomy or     taking spironolactone in patients with aldosteronism. Autonomous elevated aldosterone will     increase the glomerular filtration rate and renal damage in patients with primary     aldosteronism (PA). But clinical evidence of the role of endothelium function on     post-adrenalectomy or taking spirolactone is still limited.   "
220888|NCT00746083|"     The purpose of Challenge! is to determine if adolescents enrolled in a health promotion/     obesity prevention program will have a healthier BMI-for-age z-score and body composition     (body fat %), will consume a healthier diet, and engage in higher levels of physical activity     compared to those that did not receive the intervention over time.   "
220889|NCT00746096|"     The purpose of this study is to determine whether combination oral contraceptive pill of     norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.   "
220890|NCT00746109|"     Superficial skin and soft tissue abscess are frequently managed by opening them up with a     procedure called incision and drainage. It is routine practice in the United States to     place packing material inside the abscess cavity after opening them up, in order to promote     better wound healing and limit abscess recurrence. However, this practice has never been     systematically studied or proven to decrease complications or improve healing. Patients with     wound packing usually return to the emergency room or practice setting for multiple wound     checks and dressing/packing changes which lead to missed days from work or school and     utilization of healthcare resources. This procedure can often be painful and may even require     conscious sedation (and the risks entailed) especially in children. With rates of superficial     skin and soft tissue abscesses on the rise, and emergency room resources being stretched, it     is important to determine whether packing wounds is necessary or even advantageous to     patients.      This study is the first to systematically evaluate the efficacy of wound packing after     superficial skin or soft tissue abscess incision and drainage in children. The investigators     will be evaluating wound healing, complications, recurrence and pain associated with packing     both short and long term. In addition, the investigators will also be evaluating the utility     of bedside point-of-care ultrasound use in predicting the presence of pus inside the abscess     cavity. This test may be useful to determine whether incision and drainage is necessary for     an individual who has a skin infection that is suspicious for an abscess.   "
220891|NCT00746122|"     The purpose of this trial is to assess whether a strategy of endovascular repair (if aortic     morphology is suitable, open repair if not) versus open repair reduces early mortality for     patients with suspected ruptured abdominal aortic aneurysm.   "
220892|NCT00746135|"     It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position     (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually     optimized Left Ventricular (LV) lead placement and CRT timing on the outcome of cardiac     resynchronization therapy (CRT).   "
220908|NCT00746343|"     The primary aim of this project is to understand whether it is possible to reduce medical     risk factors in adults with bipolar disorder and, in doing so, to improve psychiatric and     functional outcomes. We will examine the role of behavioral risk factors and presumed     behavioral mediators and moderators of health risk in individuals suffering from bipolar I     disorder. The investigators will employ an innovative behavioral intervention with guideline     based psychiatric care ( Integrated Risk Reduction Intervention - IRRI) in order to target     modifiable medical risk factors.   "
223333|NCT00774046|"     The purpose of this study is to determine the effectiveness of a particular combination of     drugs used to treat cancer.   "
220893|NCT00746148|"     Polycystic Ovary Syndrome (PCOS) is very common, affecting approximately 5% of women of     reproductive age, and impacts not only on quality of life, but also has long-term health     consequences for many sufferers, such as increased risks of developing Type II diabetes,     cardiovascular disease and cancer of the womb. The symptoms that may occur such as irregular     periods; lots of body hair; thinning hair on scalp, obesity and infertility, can also lead to     poor self-esteem. Whilst treatments can help fertility, other treatments to correct the other     symptoms are less successful. Alternative methods to regulate periods would be helpful,     especially ones which avoid the long-term use of steroids in patients who may already be     overweight. Reflexology is poorly represented in scientific papers, with nothing published     regarding reflexology and its effect upon PCOS. However patients who use reflexology report     more regular periods, thicker hair on scalp and greater wellbeing. Therefore we aim to     investigate the effect of reflexology on:        1. The menstruation cycle (normal being every 21-35 days).        2. Imbalances in hormone, insulin and blood sugar levels associated with PCOS.        3. Other problems associated with PCOS such as thinning hair on scalp, excessive body hair,          and obesity.        4. Quality of life. Government and NHS agendas agree that if there's evidence of an          effective complimentary therapy the NHS should provide it. Therefore the results may          have an influence on the care pathways of patients with PCOS towards a more holistic,          patient centred and empowered approach. It is also non invasive and liable to result in          higher patient satisfaction regarding their treatment. This research may also inform          policy makers so that complementary medicine provision is provided on a wider basis          within the NHS, which at the moment is dictated by the individual Trust's budget          allocation. However this research could save money overall as in America, the yearly          cost of treating PCOS is $4.36 billion.   "
220894|NCT00746161|"     The purpose of this study is to evaluate the double tract reconstruction after total     gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was     conducted to compare double tract method with Roux-en-Y method   "
220896|NCT00746187|"     The purpose of this study is to compare marginal bone level changes between ASTRA TECH     Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial     edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical     protocol will be used. Implants will be loaded within 15 weeks from installation. The     subjects will be followed for 3 years.   "
220897|NCT00746200|"     Since there have been few advances for constipation in laxative treatment in the last 50     years, this study is designed to evaluate the efficacy and safety of acupuncture for patients     with chronic constipation based on the theory of traditional Chinese Medicine.   "
220898|NCT00746213|"     This is an investigation on the frequency of chronic pain after thoracotomy for lung cancer.     Factors relating to the development of chronic pain are investigated. Questionnaire survey.   "
220899|NCT00746226|"     Birch pollen allergy is one of the most common forms of respiratory allergy in the Nordic     countries. Treatment consists of antihistamine use. Specific probiotic strains have been     observed to modulate the immune system. Since the body has a common mucosal immune system; it     was hypothesised that consumption of probiotics may affect also the respiratory mucosal     immune response and hence affect respiratory allergy.      Earlier studies with probiotics had been unable to show improvements in adults with pollen     allergy. It was therefore hypothesised that children, who's immune system is not yet fully     developed, might be better targets.   "
220900|NCT00746239|"     Almost 80% of panic disorder patients report difficulty sleeping. Sleep disturbances in turn     may exacerbate underlying anxiety/panic attacks. Moreover, individuals with insomnia (sleep     disturbance) are at higher risk of developing a new anxiety disorder. Therefore it is     expected that improving sleep quality with medications along with other medications to treat     anxiety component of panic disorder might be helpful. However, there is lack of     pharmacological studies examining the effects of improving sleep disturbances with     medications in panic disorder patients, which is a critical problem for providing optimal     care to these patients. The objective of this proposal is to determine the effects of     ramelteon (FDA approved for insomnia) on sleep disturbances in Panic disorder patients who     are on escitalopram for underlying anxiety.   "
220901|NCT00746252|"     The purpose of this study is to learn more about weight gain and related side effects when     children are treated with antipsychotic medicine for mood disorders.   "
220902|NCT00746265|"     This project compares gold standard cognitive-behavioral therapy (based on LEARN, Diabetes     Prevention Program, LOOK Ahead) used in both research and clinical settings, with     acceptance-based behavioral therapy for weight loss. Standard behavior treatment (SBT)     focuses on modifying eating, thinking, and activity levels. Participants limit their daily     caloric intake, keep food records, increase physical activity, and practice weight control     behaviors, such as stimulus control, cognitive restructuring, alternative coping skills, and     distinguishing hunger from cravings. The acceptance-based approach (ABT) incorporates the     behavioral and nutritional components, but replaced the cognitive and motivational components     with components that are consistent with an acceptance-based approach, such as acceptance and     willingness to experience cravings, cognitive defusion, mindfulness training to interrupt     automatic eating, and values work. These components are drawn from Acceptance and Commitment     Therapy (ACT; Hayes, Strosahl, & Wilson, 1999), a cognitive-behavioral therapy that has been     gaining increasing attention and empirical support (Bach & Hayes, 2002; Bond & Bunce, 2000;     Hayes et al. 2004). Though relatively new, acceptance-based strategies have demonstrated     effectiveness in helping individuals to respond to unwanted thoughts and feelings (Hayes,     Rissett, Korn, Zettle, Rosenfarb, Cooper, & Grundt, 1999, Keogh, Bond, Hanmer, & Tilston,     2005) and offer a novel alternative to control-based strategies (such as distraction and     confrontation).      Participants in this study will be randomly assigned to either the traditional behavioral     therapy condition (SBT) or the acceptance-based behavioral therapy condition (ABT). Both     conditions are delivered in group format. A total of 30, 75 minute sessions will take place     over the course of 40 weeks.      Specific Aims        1. To evaluate the feasibility and acceptability of the treatment, and its short and          moderate-term effectiveness relative to the current gold standard behavioral treatment          (SBT).        2. To evaluate the effectiveness of ABT with novice clinicians and with weight control          experts.        3. To evaluate the effectiveness of ABT would be moderated by mood disturbance, emotional          eating, disinhibition or susceptibility to food stimuli.   "
220903|NCT00746278|"     Laparoscopic ovarian cystectomy is widely used for the removal of benign ovarian cysts but     damage to ovarian reserve caused by electrocoagulation has recently been questioned.      The purpose of this study is to investigate the impact of bipolar and ultrasonic scalpel     electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.   "
220904|NCT00746291|"     to investigate the function of the autonomic nervous system in children with with post     traumatic brain injury and children with cerebral palsy through an analysis of heart rate     variability (HRV) occurring with walking performance.   "
220905|NCT00746304|"     To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy     for infantile and acquired esotropia.   "
220911|NCT00746382|"     The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal     roflumilast cream in the treatment of atopic dermatitis in adults. This is a multicenter,     randomized, double-blind, placebo-controlled, parallel group study. 2-5 % of the body surface     area (BSA) should be covered with a mild form of atopic dermatitis. In a 4-week treatment     period 38 mg cream is applied two times daily on 0.5 to 1 % of the BSA. After a screening     phase, a washout phase of flexible duration (max 30 days, time depending upon     pre-medication), the 28 day treatment phase follows.As roflumilast is a potent     antiinflammatory substance, a positive effect on this form of dermal disease is anticipated.   "
220912|NCT00746395|"     This investigation is designed to compare lubiprostone and placebo for cleansing and     propulsion in preparation for capsule endoscopy.   "
220913|NCT00746408|"     Medical expert systems in combination with portal searching meta-search engines are exploited     to provide reliable patient-tailored information. A prototype of a web-based information     system has been developed and is to be evaluated. Its aim is to answer the decisive question     whether expert system guided internet meta-search provides a better information supply for     patients seeking health information online then this is possible by using ordinary search     engines or health portals. The research does neither investigate the influence of ethical nor     legal aspects of internet health information supply.   "
220927|NCT00746590|"     This an open-label study designed to evaluate the anti-tumour activity and safety of Prolarix     in subjects with advanced hepatocellular carcinoma.      Prolarix is a chemotherapy comprised of tretazicar as prodrug and caricotamide as     co-substrate for the endogenous enzyme, NQO2.   "
221000|NCT00747552|"     The observational study is designed to determine the feasibility of performing     Intra-Abdominal Pressure (IAP) via bladder pressure measurements and of tracking IAP in     neonates who require bladder catheterization. Correlation of IAP measurements with clinical     status of the neonatal abdomen will help determine threshold values for Intra-Abdominal     Hypertension (IAH) in the neonate.   "
220914|NCT00746421|"     Quetiapine has been reported to have beneficial cognitive effects in several randomized     controlled trials in schizophrenia. It has not yet been studied in bipolar disorder, but     promising results from the use of extended release quetiapine for the maintenance treatment     of bipolar disorder suggests that its cognitive benefits could be detected. Moreover,     quetiapine has been shown to have direct beneficial effects on performance-based measures of     social competence in schizophrenia and to improve quality of life (QoL) in bipolar     depression. The investigators propose to study quetiapine augmentation of mood stabilizer     monotherapy in clinically stable patients with bipolar disorder. This will be a randomized,     placebo controlled trial, with attentional impairments as the primary outcome and other     cognitive performance variables and measures of social and everyday living skills, as well as     subjective QoL, as the secondary outcomes.   "
220915|NCT00746434|"     The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal     roflumilast cream in the treatment of plaque psoriasis in adults. This is a multicenter,     randomized, double-blind, placebo-controlled, parallel group study. 3-10 % of the body     surface area (BSA) should be covered with a mild to moderate form of plaque psoriasis. In a     4-week treatment period 76 mg cream is applied two times daily on up to 2% of the BSA. After     a screening phase, a washout phase of flexible duration (max 30 days, time depending upon     pre-medication), the 28 day treatment phase follows. As roflumilast is a potent     anti-inflammatory substance, a positive effect on this form of dermal disease is anticipated.   "
220916|NCT00746447|"     This study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine     granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine     granules for maintenance of remission in patients with ulcerative colitis   "
220917|NCT00746460|"     The investigators hypothesize that having health care providers other than physicians within     a Groupe de Médecine de Famille conduct cardiovascular risk assessments and teach lifestyle     interventions to primary prevention patients will increase the likelihood that patients will     adopt and maintain healthy lifestyles. These objectives will be supported by providing     subjects with a cardiovascular risk profile estimating the subject's risk of cardiovascular     disease and teaching them how to use the resources related to lifestyle changes available on     the www.myhealthcheckup.com Web site.   "
220918|NCT00746473|"     A cross-sectional study was performed on HIV-1 infected individuals with or without     antiretroviral treatment. 73 HIV-1 infected individuals were divided into three groups: G1=     15 infected individuals with or without AIDS who never received ARV; G2= 27 patients on     HAART, and plasma HIV-1 RNA viral load (VL) equal or greater than 50 copies/mL and G3= 31     patients on HAART with undetectable VL for at least the past 6 months and a fourth group G4=     20 individuals chosen between blood donors without any disease sign and with negative HIV     serum tests (control group). Serum cytokine levels pg/mL (ELISA) and specific mRNA expression     by RT-PCR were performed on all four groups for TNF-a, IL-2, INF-g, IL-4 and IL-10. All     patients were submitted to VL determination and CD4+ and CD8+T lymphocyte counts. Results     analysis showed a significant comparison between groups for both methods and association     between them (>80% - r2>0.80) with only one exception, in the individuals of control group,     for IL-2 by ELISA determination. The cytokine profile for both methods and three patient     groups was mature Th-0. The behavior of IL-2 and INF-g must be emphasized with the consequent     expression on dominant Th profile. Both methods showed low IL-2 and elevated mean INF-g     values in the three patient groups.   "
220919|NCT00746486|"     The study is aimed to compare the efficacy and tolerability of a combination therapy with     ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs.     ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. Depending on     ALT values 6 mg/d budesonide are allowed. The study population will be patients with PBC at     risk for disease progression. It is assumed that the combination therapy will result in a     decrease of treatment failures after 3 years of treatment.   "
220920|NCT00746499|"     Healthy subjects will take study drug by mouth twice a day for 7 consecutive days, blood and     cervicovaginal samples will be taken most mornings around the AM dose. Two visits, ~14 hrs in     length will be required on Day 1 and 7. The purpose of this study is to measure how much     raltegravir is found in the genital tract after taking it orally.   "
220921|NCT00746512|"     The study will compare the effects of prednisone vs placebo on synovial blood flow and     overall DAS (disease activity score) in patients with rheumatoid arthritis.   "
220922|NCT00746525|"     The purpose of this trial was to evaluate the benefits of combination motor learning training     and brain computer interface training for restoring arm function in people with stroke. Our     aim was to determine whether the surface-acquired brain signal (electroencephalography (EEG))     can feasibly be used as a neural feedback system to drive more normal motor function in     stroke survivors.   "
220923|NCT00746538|"     The purpose of this study is to compare the quality of life in patients with unresectable     hilar cholangiocarcinoma on palliative metallic stent versus plastic Stent.   "
220926|NCT00746577|"     Purpose of the Study:      The Richmond Behavioral Health Authority's Substance Abuse Services Division and Virginia     Commonwealth University's Institute for Drug and Alcohol Studies are working on an important     research study to improve the quality of substance use disorder treatment services offered by     RBHA and its contracted services providers. Specifically, this preliminary research will     provide the information needed to conduct a planned series of program-specific interventions,     designed to increase the adoption of evidence-based practices (EBPs) within specific     programs. A major goal of the study is to better understand what factors influence the     adoption of EBPs, and what adoption strategies work best for which types of staff, which     types of programs, and under what conditions.      Description of Staff Involvement:      In this study, staff will be asked to complete questionnaires about themselves, their     workplaces, and their perceptions about the services their organization provides. Some of     these questionnaires will be given to staff when they first enter the study, and others may     be given to staff before and about 9 months after a 3-day Practice Improvement Workshop     (please note that each agency may or may not be selected to complete the workshop).      Description of Client Involvement:      Clients at each participating site will be asked to complete a brief survey about the     services they receive at that site. This survey will occur at the initial timepoint, and at     several later timepoints. This survey is confidential and anonymous.   "
220928|NCT00746603|"     Lay abstract: Study Purpose With contemporary combined modality therapy the expected longterm     survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus,     the emphasis for future therapeutic interventions must include attention to the late effects     of therapy. The development of cardiovascular disease as a late effect of radiation therapy     has been well described and documented. Our recent pilot study of child and young adult HD     survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid     Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were     positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic     BP. This finding was present in children and young adults who had received no or low dose     radiation suggesting that chemotherapy or the disease process itself contributes to the     development of atherosclerosis and risk for cardiovascular disease. Numerous studies have     shown HMG CoA reductase inhibitors (statins) to be effective in reducing the progression of     atherosclerosis in adults. These agents have been studied in children and young adults for     over a decade.      The primary aim of this study is:      To obtain pilot safety data on the use of simvastatin in young adults treated for HD.      The secondary aims of this study are:      To obtain pilot data on the effect of simvastatin on subclinical carotid artery     atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD.      To obtain pilot data on the effect of simvastatin on markers of inflammation measured in the     serum of young adults treated for HD.      To obtain pilot data to serve as the basis for the development of a multicenter randomized     study for the use of simvastatin in survivors of HD.   "
220929|NCT00746616|"     The purpose of the study is to gather clinical information on the safety and efficacy of the     resurfacing devices in the young, active patient with advanced hip disease. Study enrollment     has been temporarily suspended due to a change in the surgical technique.   "
220930|NCT00746629|"     The purpose of this study is to compare the efficacy of two different approaches (prescribed     & self-directed) to the treatment of childhood obesity and their relative impact on child     weight status, physical activity, and diet.   "
220931|NCT00746642|"     Most patients with diabetes mellitus have to measure their blood glucose levels quite often,     in order to maintain a proper glycemic control. Current methods of self-monitoring of blood     glucose are invasive, painful, uncomfortable, and only allow occasional, from time-to-time,     measurements. Real-time continuous monitoring would provide a helpful tool for improvement of     glycemic control, thus decreasing the incidence of hypoglycemia and improving glucose     control. The Mellitor sensor is a new concept of continue glucose monitoring device. The     Mellitor device is an implantable continuous glucose monitoring sensor that is intended for     detection episodes of hyperglycemia and hypoglycemia in diabetic patients, and facilitates     both acute and long-term therapy adjustments. This study was design in order to evaluate     glucose measurement capabilities by the Mellitor sensor that is being developed. Transudate     liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be     used for glucose measurement by the Mellitor sensor.      Study Design      This study is an ex-vivo comparative study. 20 patients will be recruited for the study,     according to patients' inflow and meeting eligibility criteria.      Study Goal      Study objective is to evaluate the feasibility of the Mellitor Sensor technology for glucose     level measurement.      Study Endpoint      Mellitor technology feasibility will be established by comparing Mellitor glucose     measurements results, based on transudate/exudates liquid withdrawal for other medical     reasons, to gold standard, Yellow Springs glucose analyzer, or a comparable, calibrated and     approved device using the same transudate/exudates liquid. Interdevice variability should be     within 10%.   "
220932|NCT00746655|"     The purpose of this study is to determine the feasibility and toxicity of combining SBRT and     TACE for unresectable HCC and to evaluate the Health Related Quality of Life (HRQL)     associated with combined therapy.   "
220933|NCT00746668|"     The purpose of this study is to measure the effectiveness of a newly-designed oculomotor     training program for patients with macular disease, including age-related macular     degeneration.   "
220934|NCT00746681|"     Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is     designed to a investigate whether pregabalin may have efficacy in OAB and whether the     efficacy is altered when it is combined with tolterodine.   "
220935|NCT00746694|"     The objective of this trial is to study the management of PPE in participants with metastatic     ovarian or breast cancer treated with Caelyx, and determine the frequency of use of     pharmacological treatment (preventive or therapeutic) for PPE and compliance of educational     recommendations for PPE.   "
220936|NCT00746707|"     The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for     first degree perineal tears repair   "
220939|NCT00746746|"     The purpose of this study is to determine the safety of giving subjects with advanced,     recurrent or refractory melanoma the HyperAcute® Melanoma vaccine with a variant of a drug,     called Interferon (PEG-Intron®) that is specially formulated to be given on a weekly basis     (instead of daily). The study vaccine (HyperAcute®-Melanoma) is made from three types of     human melanoma cell lines (grown in the laboratory) in which the genes have been slightly     changed. This clinical study will try to discover the safety of the study vaccine combined     with PEG-Intron®, its side effects and the potential benefits, if any.   "
220940|NCT00746759|"     The purpose of the research study is to develop a new, more sensitive, and less invasive test     for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The     investigators hypothesize that certain genes are expressed differently in current and former     smokers who have lung cancer, and this difference in gene expression may be a biomarker for     lung cancer.   "
220981|NCT00747305|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed. Giving it after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This clinical trial is studying how well sunitinib works when given before and after     surgery in treating patients with metastatic kidney cancer that can be removed by surgery.   "
220982|NCT00747318|"     The objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA     pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have     completed the study SKY2028-3-005.   "
220941|NCT00746772|"     Oral lichen planus (OLP) is a chronic inflammatory disease whose prevalence in the general     population is 0.5 -2.2%.Oral lesions in OLP are chronic, rarely undergo spontaneous     remission. Patients with OLP had significantly increased risk of oral squamous cell     carcinoma, irrespective of the clinical type of OLP and therapy. there is currently no cure     for OLP. Previous study demonstrated a decreased antioxidant defence and increased oxidative     damage to lipids.DNA and proteins in lichen planus. This oxidative modifications point to     pathophysiological alterations mainly within the basal cell layers of epidermis and at the     dermoepidermal junction. Purslane is an excellent source of vitamin A,C and E and essential     amino acids, has been described as a power food of the future because of its high nutritive     and antioxidant properties. The purpose of the study was to determined the efficacy of     Purslane in the treatment of oral lichen planus.   "
220942|NCT00746785|"     Craving for alcohol has been related to loss of control drinking and is a major target of     biological and behavioral interventions for alcohol dependence. Our previous research has     demonstrated that olanzapine (a dopamine antagonist) attenuates craving for alcohol, that a     variant in the gene that expresses D4 receptors influences craving for alcohol, and that     olanzapine is particularly effective at reducing craving among individuals with this variant.     Pilot data from a recent 12 week trial of olanzapine indicates that olanzapine is well     tolerated and that olanzapine reduces drinking, particularly among individuals with the     aforementioned genetic variant. The objective of the present application is to examine the     effectiveness of olanzapine (5 mg/day), as compared to olanzapine (2.5 mg/day) and a placebo     control, in terms of reducing craving and alcohol use behavior among treatment seeking     alcoholics. Furthermore, the present application will examine whether the effects of     olanzapine on drinking outcomes are mediated by its effects on a specific putative mechanism     (i.e., cue-elicited craving for alcohol) and determine whether the DRD4 VNTR polymorphism is     a marker for the effectiveness of olanzapine. To that end, 202 alcohol dependent subjects     will be randomly assigned to medication group and receive 12 weeks of medication. Subjects     will complete follow-up assessments at 3 and 6 months after the end of the treatment. It is     expected that olanzapine will significantly reduce cue-elicited craving and alcohol use     behavior in a dose dependent fashion over the course of the 12 week trial and follow-up     period, as compared to the placebo condition. Furthermore, it is expected that the effects of     olanzapine on alcohol use behavior will be mediated by the effect of olanzapine on     cue-elicited craving and that the effects of olanzapine on cue-elicited craving and alcohol     use behavior will be moderated by the DRD4 VNTR, such that olanzapine will be more effective     among individuals with the 7 repeat allele. The successful completion of the proposed     research is expected to advance a new medication for alcohol dependence and advance genetic     markers that predict the effectiveness of this medication.   "
220943|NCT00746798|"     The purpose of this study is to determine if ChimeriVax West Nile vaccine is safe and     effective in preventing West Nile disease in adults over 50 years of age.   "
220944|NCT00746811|"     The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo,     on LDL-C and other aspects of the fasting lipid profile in subjects with primary     hypercholesterolemia.   "
220945|NCT00746824|"     The purpose of this study is to determine the effects of TM30339 on weight loss in obese     individuals after 28 days dosing.   "
220946|NCT00746837|"     The purpose of the study is to estimate the absolute bioavailability at steady state of 2     doses of AZD5672 (50 mg and 150 mg administered orally once daily)   "
220947|NCT00746850|"     In the developmental stage of laparoscopic cholecystectomy it was considered 'unsafe' or     'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis. With     increasing experience in laparoscopic surgery, a number of centers have reported on the use     of laparoscopic cholecystectomy for acute cholecystitis, suggesting that it is technically     feasible but at the expense of a high conversion rate, which can be up to 35 per cent and     common bile duct lesions.      The HARMONIC SCALPEL® (H) is the leading ultrasonic cutting and coagulating surgical device,     offering surgeons important benefits including: minimal lateral thermal tissue damage,     minimal charring and desiccation.      H technology reduces the need for ligatures with simultaneous cutting and coagulation:     moreover there is not electricity to or through the patient H has a greater precision near     vital structures and it produces minimal smoke with improved visibility in the surgical     field.      In retrospective series LC performed with H was demonstrated feasible and effective with     minimal operating time and blood loss: it was reported also a low conversion rate (3.9%).      However there are not prospective randomized controlled trials showing the advantages of H     compared to MD (the commonly used electrical scalpel) in LC.      Aim of this RCT is to demonstrate that H can reduce conversion rate compared to MD in LC for     AC.   "
220948|NCT00746863|"     There are many ways to perform a suprapubic approach pubovaginal sling. Some surgeons inject     local pain medical into the retropubic space before placing the sling, others do not. This     study is to determine if injection of local pain medication into the retropubic space before     placing a mid-urethral sling for urinary stress incontinence results in lower postoperative     pain scores, lower use of postoperative narcotic medication and lower rates of urinary     retention.   "
220949|NCT00746876|"     Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures).     Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses     has a one-piece design where the hip movement occurs between the prosthesis and the     acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the     two components of the prosthesis. Both treatments are clinically proven and common around the     world. No clinical trial has proven benefits of one or the other prosthesis design. The     investigators want to measure the differences in acetabular wear using these two prostheses,     using radiostereometric measurements.   "
220950|NCT00746889|"     A study using characteristics on ultrasound to predict response to intraarticular steroid     injections in patients with knee osteoarthritis. The hypothesis is that patients with     inflammation on ultrasound will have a better response to corticosteroid injections compared     to patients without inflammation.   "
221055|NCT00738621|"     The purpose of this study is to compare the efficacy of the use of oral aprepitant in     combination with intravenous ondansetron and dexamethasone with the efficacy provided by the     use of oral aprepitant and dexamethasone for preventing vomiting during the first 24-48 hours     after breast surgery.   "
220983|NCT00747331|"     Cardiopulmonary bypass (CPB) for cardiac operations may be accompanied by different patterns     of visceral underperfusion. This could result in clinical patterns of lactic acidosis but in     the most severe cases there is the risk for mesenteric infarction (0.2% of the cases). Renal     function as well may be impaired due to a low oxygen delivery, and acute renal failure occurs     in 1-2% of cases.      Fenoldopam mesilate is a selective splanchnic vasodilator when used at a dose < 0.1     mcg/kg/min.      The experimental hypothesis of this randomized, controlled trial (RCT) is that the use of     fenoldopam may determine a better visceral perfusion during CPB.   "
220984|NCT00747344|"     The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the     treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.   "
236234|NCT00949130|"     The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs.     established treatment of acute bacterial infection in adults.   "
220951|NCT00746902|"     The purpose of the study is to investigate the links between blood pressure (BP), overweight     or obesity, and sleep apnea syndrome (SAS), by studying a large cohort of subjects suffering     from refractory hypertension.      Primary objective        -  To compare plasmatic leptin levels in patients suffering from refractory hypertension          depending on whether or not they experience SAS.      Secondary objectives        -  To ascertain what determines the difference in plasmatic leptin concentrations in          patients suffering from refractory hypertension depending on whether or not they          experience SAS.        -  To characterise BP readings (from clinical and ambulatory (ABPM) measurements) in          patients suffering from refractory hypertension depending on whether or not they          experience SAS.        -  To characterise metabolic parameters (lipids, glycaemia, adiponectin) and sympathetic          nervous system effectors (adrenaline, noradrenaline and metanephrines) in patients          suffering from refractory hypertension depending on whether or not they experience SAS.        -  To characterise BP readings, metabolic parameters and sympathetic nervous system          effectors in patients suffering from refractory hypertension according to the severity          of the SAS (in those who experience this problem).        -  To study, in patients with both SAS and refractory hypertension, the impact of nasal          continuous positive airway pressure (CPAP) treatment on BP readings, metabolic          parameters and sympathetic nervous system effectors, by comparing those who are          compliant with the CPAP regimen with those who are non-compliant.   "
220952|NCT00746915|"     The objectives of this study are to evaluate the safety and initial efficacy of the epidural     injection procedure when combined with real-time multi-frequency bio-impedance measurements     that collect data on the electrical bioimpedance characteristics of living human tissue on     the path of the epidural needle.   "
220953|NCT00746928|"     The study is a prospective field evaluation to assess the effects of the chronic Intermittent     Hypoxia exposure in 12 healthy humans.      Precisely, the study was designed to :      Set up a new model of Chronic Intermittent Hypoxia (CIH) applied to healthy human. This CIH     is mimicking the CIH undergone by patients suffering from Sleep Apnea Syndrome.      Evaluate the cardiovascular effect of CIH. Neuronal and humoral sympathetic control, blood     pressure control, vascular resistance.      Evaluate the Sleep quality, the ventilation under exposure and the long terms effect on     ventilation control of CIH (central and peripheral chemoreflex).      Investigates the biological aspects of CIH exposure.   "
220954|NCT00746941|"     The primary objective of the study was to explore whether mefloquine can delay or stop     progression of progressive multifocal leukoencephalopathy (PML) as measured by JC virus     (human polyomavirus or JCV) deoxyribonucleic acid (DNA) levels in cerebrospinal fluid (CSF).     The secondary objective of the study was to explore whether mefloquine can delay or stop     progression of PML based on neurological deterioration, magnetic resonance imaging (MRI)     measures of brain lesion evolution or the formation of new lesions, and mortality.   "
220955|NCT00746954|"     The purpose of this study is to determine whether buspirone compared to acetazolamide and to     placebo will reduce the number and/or severity of breathing pauses during sleep that occur in     some patients with Heart Failure.   "
220956|NCT00746967|"     The purpose of this study is to evaluate the safety and toleration of oral sildenafil     administered as required by women with Female Sexual Arousal Disorder (FSAD) who successfully     complete one of the following Pfizer-sponsored, 12-week, double-blinded clinical trials:     A1481082 or A1481123. Addition of this 52-week open-label extension will increase the total     duration of sildenafil exposure to 64 weeks. Sustained efficacy will also be evaluated after     3 and 6 months of open-label therapy.   "
220957|NCT00746980|"     Determine the effect that treatment with efalizumab has on scalp hair re-growth in younger     adults affected by severe variants of alopecia areata, including alopecia totalis, alopecia     universalis, and severe ophiasis variants.   "
220958|NCT00746993|"     In the United States, highly effective methods of birth control are often not used.     Healthcare providers use birth control counseling and patient education as ways to increase     the usage of birth control. However, little evidence exists to show that patient education     and birth control counseling changes birth control use.      We want to evaluate the effectiveness of using a uniform set of birth control information to     provide birth control education to women having an early pregnancy termination. The     counselors will allow the clients to both read as well as hear the information. We propose to     evaluate whether this counseling will lead to 1) more women choosing highly effective     nonpermanent birth control methods and 2) more women continuing to use these methods for a     longer time.      Women in the study will complete a questionaire about their health. Half of them will have     the structured counseling and half will have the routine counseling currently offered to     women as a part of their routine care. We will contact all study participants with a     telephone call three months and six months later to have a 10 minute conversation about what     birth control they are using.   "
220959|NCT00747006|"     The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder     is established for either a type 1 or 2 patient, based on a average diabetic meal, the     patient's favorable dose can be used safely, regardless of change in meal carbohydrate     content. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150%     or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose     for their normal meal.   "
220960|NCT00747019|"     The purpose of this study is to compare two exercise programs to determine how well they help     older adults make exercise a regular habit after 9 months.   "
220961|NCT00747032|"     The aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of     Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study     product will be applied to the affected skin, excluding the face, once daily, at     approximately the same time daily.   "
220980|NCT00747292|"     The aim is to ascertain which method out of epidural, spinal or patient controlled analgesia     (PCA) is the most appropriate in fluid optimised patients after laparoscopic colorectal     surgery in terms of pain control, length of hospital stay and time for gut recovery. The     second aim is to assess the physiological changes that occur when the patient is placed in     steep trendelenberg position together with the creation of the pneumoperitoneum.   "
221056|NCT00738634|"     The purpose of this study is to determine whether physical activity prevents development of     depressive symptoms in adolescents.   "
220962|NCT00747045|"     Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by unresolved thromboemboli     in the pulmonary arteries, which lead to pulmonary hypertension and, left untreated, right     heart failure. This disease can be potentially cured by performing a pulmonary     thromboendarterectomy (PTE) to remove the blood clots. The surgery is not without risk and     the most worrisome complication is the development of a form of acute lung injury called     reperfusion lung injury, which occurs in about 40 percent of patients.      The landmark publication of the ARDSNET study demonstrated that a low tidal volume strategy     of mechanical ventilation, decreased morbidity and mortality in patients who had acute     respiratory distress syndrome (ARDS). Since then there have been some studies examining the     role of a low tidal volume strategy in all patients who are mechanically ventilated. Some     studies have demonstrated a decreased incidence of acute lung injury while others have failed     to do the same. In patients at high risk for developing acute lung injury, such as patients     undergoing PTE, there may be a benefit to using low tidal volumes to reduce the incidence of     reperfusion lung injury.      To assess the efficacy of a low tidal volume ventilation strategy in patients undergoing PTE,     134 patients will be randomized at the time of surgery to either low tidal volumes (6ml/kg of     ideal body weight), or standard tidal volumes (10ml/kg of ideal body weight). Patients will     be followed clinically to assess for the development of reperfusion lung injury. This will be     defined as the development of hypoxemia (PaO2/FiO2 ratio less than 300) and chest infiltrates     in the area of reperfused lung with no other identifiable etiology within the first 72 hours     of surgery. Patients will also be assessed for other factors known to contribute to acute     lung injury including: plateau pressures, peak inspiratory pressures, fluid balance, and     number of transfusions received. Secondary endpoints of the study will be: time to successful     spontaneous breathing trial, ventilator free days, ICU free days, hospital free days, and     mortality.   "
220963|NCT00747058|"     The purpose of this study is to determine the safety and tolerability of PF-03864086 in     healthy male human volunteers. Determine the pharmacokinetics (calculations of the rate of     elimination of PF-03864086 from the body once the compound is ingested).   "
220964|NCT00747071|"     This clinical study is designed to evaluate the safety and efficacy of oral administration of     the food additive colostrum derived antibodies to Clostridium difficile for prevention of     Clostridium difficile associated disease (CDAD).   "
220965|NCT00747084|"     This research study compares two methods of performing colonoscopy without sedation. The     standard method is to insert the colonoscope without adding any water to the colon, and when     colonic spasms occur during the examination, waiting for the spasms to subside before     continuing with the insertion of the colonoscope. The study method involves putting 200 ml (7     oz) of warm water through the colonoscope into the colon at the beginning of the examination,     and when colonic spasms occur during the examination, putting 30 ml (1 oz) of warm water into     the spastic area(s) to relax the colonic spasms.   "
220966|NCT00747097|"     The purpose of this phase II study is to assess the efficacy of combined chemotherapy using     gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.   "
220967|NCT00747110|"     The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9     mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative     colitis.   "
220968|NCT00747123|"     Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and     efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma.   "
220969|NCT00747136|"     The purpose of this study is to demonstrate the clinical utility of the WavSTAT Optical     Biopsy System as an adjunctive tool to improve the endoscopist's clinical sensitivity to     identify dysplasia or cancer in the esophagus.   "
220970|NCT00747149|"     This study will assess if customizing the start dose of rosuvastatin appropriate for the     degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with     either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic     patients previously treated with another statin and not at LDL-C targets.   "
220971|NCT00747162|"     The investigators plan to enroll 500 consecutive Subjects at a major trauma center for this     study. For each patient, the body mass index (BMI), age, sex, diastolic pressure and mean     arterial pressure (MAP) at time of measurements. Additional information including diseases     such as diabetes and vascular disorders will be recorded. Social demographics including     alcohol and tobacco use will be recorded. This is important as alcohol and tobacco use could     also contribute to cardiovascular diseases. The skin pigmentation of each subject will be     recorded. Two different methods will be used for this measurement. Each patient will be     graded on a six point scale as described by Young (Young, 1997). Additionally, each subject     will have their skin measured using a reflectance colorimeter. The colorimeter,     DermaSpectrometer II (cyberDerm, Broomall, PA) uses visible light to measure the amount of     light reflected off the skin. By measuring the light reflectance, the skin pigmentation can     be measure (Clarys, 2000). Muscle oxygenation will be measured using a continuous dual     wavelength near infrared spectrometer. Using the different absorption characteristics of     deoxyhemoglobin and oxyhemoglobin, the concentration of oxyhemoglobin in the muscle at an     approximate depth of 2.5 cm is determined. The INVOS cerebral oximeter (Somanetics, Troy, MI)     will be used for all measurements.   "
220972|NCT00747175|"     The purpose of this study is to assess safety and tolerability of AZD1656 after multiple     repeated oral doses in patients with type 2 diabetes   "
220973|NCT00747188|"     The present study aimed to compare the effect of education through problem-based learning     (PBL) or lectures on behavior, attitude and learning of nursing students.   "
220974|NCT00747201|"     This study will determine if a version of the bipolar care model adapted for a nonresearch     audience can improve patient health and correct use of the model in community-based mental     health care sites.   "
220975|NCT00747214|"     This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus     DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and     Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was     planned for 60 subjects with moderate to severe rheumatoid arthritis (RA).   "
220976|NCT00747227|"     The purpose of this study is to evaluate the safety and effectiveness of a new     investigational modified light transmission monofocal intraocular lens compared to a     conventional intraocular lens (IOL).   "
220977|NCT00747240|"     This is a prospective observational study to determine whether there is an association     between the presence of platelet-activating factor acetylhydrolase (PAF-AH) gene     polymorphisms and the development of chronic lung disease in very low birth wight infants.     Infants < 1500 grams at birth who require mechanical ventilation will be enrolled in the     first 5 days of life after obtaining informed consent. A total of 1 ml of blood will be drawn     and utilized for isolation of DNA for genotyping and for measurement of PAF-AH activity in     serum.   "
220978|NCT00747253|"     The main purpose of this study is to evaluate the safety and performance of the AutoLITT     system for the treatment of recurrent/progressive glioblastoma multiforme tumors (GBM).   "
220985|NCT00747357|"     The INDICOR study is a controlled, prospective, multicenter, randomized, two arm phase-II     real world study assessing the acute, 6 months, and 12 months and 3 year outcome of     cobalt-chromium stent (Coroflex Blue) deployment followed by Paclitaxel-eluting PTCA-balloon     dilatation (SeQuent Please) and of Paclitaxel-eluting PTCA-balloon dilatation (SeQuent     Please) followed by cobalt-chromium stent (Coroflex Blue) deployment for the treatment of     de-novo and restenotic lesions in native coronary arteries. The study will be conducted in     India.   "
220986|NCT00747370|"     The purpose of this study was to test the suitability of dynamic magnetic resonance imaging     for the pelvic floor floor, bladder neck and urethra in healthy volunteers, in stress     incontinent patient and in women with genital prolapse.   "
220987|NCT00747383|"     The study is aimed at Type 2 Diabetics who are taking Metformin, but whose Diabetes remains     poorly controlled. There are two additional medications already in use, Glimepiride and     Sitagliptin will be compared to assess levels of improvement in Diabetes control.   "
220988|NCT00747396|"     The purpose of this study is to determine the long term effects of early intervention     (placement into foster care) on physical, cognitive, social and brain development and     psychiatric symptomatology in previously institutionalized children.   "
220989|NCT00747409|"     Compared to human insulins analogue insulins offer the option of optimizing metabolism also     in type 2 diabetes. Especially, fast acting insulin analogues lower postprandial glucose     levels more effectively than human regular insulin. However, it is not known whether therapy     with analogue insulins can also improve the subclinically impaired myocardial function in     type 2 diabetes. This prospective, randomized, open long term study compared the effects of a     basal-bolus insulin therapy with analogue insulins versus human insulins on metabolic control     and systolic and diastolic myocardial function, testing the hypothesis that optimized     postprandial glucose control improves cardiac function and cardiovascular risk.   "
220990|NCT00747422|"     The purpose of this study is to look at how safe and effective the Ulthera ultrasound system     is at reducing the appearance of wrinkles when used with subjects who have wrinkles around     the eyes.   "
220991|NCT00747435|"     The purpose of this investigation is to demonstrate the safety and effectiveness of the     MED-EL Electric-Acoustic System (EAS), a medical device that combines the use of a cochlear     implant with an external electric-acoustic processor designed to provide benefit in speech     perception and sound quality to individuals with a sensorineural hearing loss with minimal     changes in residual hearing. The acoustic component of the processor will aid residual     acoustic hearing in low frequency ranges, while the cochlear implant and electric component     of the processor will be used to electrically stimulate the auditory nerve across a wide     range of frequencies necessary for speech perception.   "
220992|NCT00747448|"     The purpose of this study is to create a patient registry to collect and analyze post-510K     approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.   "
220993|NCT00747461|"     The purpose of this study is to evaluate the safety, effectiveness, and side effects of the     CryoSpray AblationTM System (CryoSpray AblationTM, CSA or cryospray therapy) to treat     benign airway disease in the lung using liquid nitrogen sprayed through a catheter via     flexible fiber optic bronchoscopy (FFB)   "
220994|NCT00747474|"     The purpose of this study is to find a safe and tolerable dose of Lipotecan® when     administered to patients with advanced solid tumors.   "
220995|NCT00747487|"     This study is meant to assess the effectiveness of idebenone on visual function measures in     patients with Leber's Hereditary Optic Neuropathy over a 6 months period.   "
220996|NCT00747500|"     The purpose of this study, is to assess the safety and local tolerability of the long-term     use of Somatuline Autogel when administered by patients or their partners (Home Injection     Group) and the safety and local tolerability in patients receiving their injection from a     healthcare professional (HCP) (Reference Group).   "
221031|NCT00738296|"     Comparison of the effect on the progression of the carotid intima-media interphase thickness     (GIM), arterial rigidity according to the measurement of the pulse wave speed and direct     measurement of the carotid and aortic rigidities and an inflammation marker (PCR) in patients     with established cardiovascular disease (myocardial infarct, atherosclerotic coronary     disease), diabetes mellitus type 2 or equivalent risk of coronary disease and a low density     lipoprotein level > 100 mg/dL, treated with simvastatin, pravastatin or the combination of     simvastatin-ezetimibe during a period of at least one year.   "
221032|NCT00738309|"     The purpose of this study to determine the radiographic and clinical outcomes of spinal     deformity surgical treatment in patients with Scheuermann's Kyphosis.   "
221033|NCT00738322|"     The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the     medication is metabolised by the body ( how it is taken up into the body, distributed around     the body and disappears from the body) in healthy Japanese males.   "
220997|NCT00747513|"     In an attempt to challenge the increasing prevalence of childhood obesity, many programs have     been executed in order to improve childrens' lifestyle. Programs involved either school,     family or environmental measures. In most, success was only limited.      The purpose of this trial is to examine the ability of a low-cost multi-component program to     improve behavioral, diet and activity habits in both school, family and afternoon settings.     Ths ultimate goal is to construct and assess a lifestyle modification program that can be     implemented in schools and kindergartens on a national level.      Participants will be ~2,500 children aged 5-12 from 22 kindergartens and elementary schools,     divided into control and intervention centers.      Teachers and students will be provided with materials in order to perform activities on     healthy food and drink choices and habits during the school day. Schools will offer increased     physical activity opportunities to children, as will afternoon community centers. Children     will be given personal exercise items. Parents will be offered lectures on topics of diet and     activity. Diet and activity habits will be assessed by a questionnaire, and height, weight     and body fat percentage will be measured before and after the program.   "
220998|NCT00747526|"     The purpose of the study is to evaluate the pharmacokinetics (how the drug is absorbed in the     body, how it is distributed within the body and removed from the body over time),     pharmacodynamics (how the study medication affects the body) and safety of rabeprazole after     single and multiple daily administration in infants between the ages of 1 and 11 months,     inclusive, with Gastroesophageal Reflux Disease (GERD).   "
221001|NCT00747565|"     To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from     two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol     DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol     DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal     control. The original study was conducted in 2004-2006; the expansion study was conducted in     2007-2008. Results from both studies were analyzed together for FDA approval.   "
221002|NCT00747578|"     Ankylosing spondylitis (AS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE)     are the most common rheumatic diseases dealt with rheumatologists in Taiwan. In previous     studies, the 3 diseases all have broad impacts on health-related quality of life of patients     and drive enormous economic burden on patients and society. The objective of this study is to     compare health-related quality of life and disease-related costs between patients with the 3     different diseases.      We will invite at least 100 patients with AS, RA or SLE respectively who are regularly     followed in the outpatient clinic of the Division of Rheumatology at Taichung Veterans     General Hospital (VGHTC) to participate in the study. Patients who have cognitive impairment,     who are older than 65 years old or younger than 18 years old, who have overlapping syndrome     of any 2 of the 3 rheumatic diseases (eg. RA overlapping with SLE) or who have visited     rheumatologists in the outpatient clinics at VGHTC for less than 4 times in 2008 will be     excluded. Patients who agree to take part will attend a comprehensive clinical examination in     the outpatient department. Patients will complete a questionaire including demographic and     disease characteristics, and health-related quality of life at the time of survey. The     questionaires about disease-related costs will be completed once per quarter throughout 2009.     The four questionaires about costs will be given at the time of initial survey and will be     returned by returned by mail or in the following outpatient clinics visits every 3 months in     2009.      The result of this study will help patients to realize their own health-related quality of     life and disease-related costs and help government in Taiwan to realize the socioeconomic     burden of the 3 common rheumatic diseases and to allocate health care resources more properly     in the future.   "
221003|NCT00747591|"     S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS)     and is increased in CSF and blood after CNS injury. There are two objectives to this study.     Is urine S100B concentration correlated with the serum concentration of S100B in infants born     at 29-36 weeks gestation. The presence and severity of intracranial pathology on S100B     concentration will be investigated. Further analysis will demonstrate if birth weight, daily     fluid intake, urine output, and urine creatinine influence this relationship.   "
221004|NCT00747604|"     This project is a retrospective (beginning January 2006) and prospective patient registry     program sponsored by Ipsen (formerly Tercica, Inc.). In collaboration with participating     health care practitioners, the patient registry program is an observational study monitoring     the long-term safety of patients treated with Increlex® (mecasermin [rDNA origin] injection).     The IGFD (Increlex® Growth Forum Database) Registry is intended primarily to monitor the     safety and efficacy of Increlex replacement therapy in children with growth failure.   "
221005|NCT00747617|"     The mechanism for increased androgen production in women with polycystic ovary syndrome     (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by     increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators     hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen     synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal     women. To test this hypothesis, the investigators propose to conduct a dose-response study in     which androgen responses to multiple doses of human chorionic gonadotgropin (hCG), an LH     surrogate, will be assessed in PCOS and normal women.   "
221006|NCT00747630|"     Evaluating the efficacy of a video about FAS to determine whether it has an impact on     knowledge about FAS and their likelihood to participate in risk taking behavior.   "
221007|NCT00747643|"     The purpose of this study was to find out how varenicline works to help people quit smoking.     Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved     medication that has been shown to help people quit smoking. This study was trying to evaluate     whether varenicline would change the response to smoking and the desire for cigarettes when     compared to an inactive placebo control. This was not a quit smoking treatment study, and     participants were not asked or required to stop smoking while in this study.   "
221050|NCT00738556|"     Most doctors who use the new drug-eluting stents for the treatment of long coronary     narrowings tend to cover the full length of the lesion with long or multiple stents. The     investigators hypothesized that a policy of spot-stenting, i.e., stenting of only the very     tight parts of the coronary narrowing, might result in better outcomes by means of avoiding     multiple stents that have been associated with significant complications such as late stent     thrombosis.   "
221008|NCT00747656|"     Despite remarkable gains in treatment over the last decade short-term mortality for those who     survive to hospital with AT-elevation acute myocardial infarction (STEMI) remains high     (5%-10%). Different studies have pointed out that reperfusion (intravenous fibrinolysis or     percutaneous coronary interventions (PCI) and its timing are critical in decreasing STEMI     patients' mortality. Studies of prehospital 12 lead electrocardiograms (12 lead PHECG) with     advance emergency department (ED) notification suggest that there is a time to treatment     advantage with this intervention. The use of 12 lead PHECG is not currently universal and     part of standard treatment throughout the province. The purpose of the study is to follow     STEMI study subjects during standard treatments and to compare the outcomes of subjects that     received 12 lead PHECG with advanced ED notification in mixed rural/urban areas with outcomes     of subjects treated in areas with only 3 lead PHECG monitoring and indirect ED notification.     The investigators hypothesize that there will be a survival benefit for study subjects with     12 lead PHECG and advance ED notification in rural and urban environments through a reduction     in door-to-reperfusion time and that 12 lead PHECG will be a cost-saving technology for the     province of Ontario.   "
221009|NCT00747669|"     This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute     application of Synera.   "
221010|NCT00747682|"     The specific aim of the research proposal in preterm infants with IVH and PHH who require     placement of an Omaya reservoir or a shunt is to determine if decreasing ventricular volume     improves, middle cerebral artery flow, cerebral oxygenation, and cortical neuronal electrical     activity. To accomplish this aim, we will simultaneously perform the following evaluations     prior to shunt placement or prior to and after routine CSF aspiration from reservoir in:        1. middle cerebral artery velocity time integral and resistive index using Doppler          ultrasonography        2. cerebral oxygenation using near infrared spectroscopy (NIRS)        3. background neuronal electrical activity using an EEG. In addition, we will measure          serial CSF concentration of neuroproteins, S100B, GFAP, NSE, TGF-ß, and IL-6, as          evidence of ongoing neuronal damage and correlate the concentration with cerebral          perfusion and activity as measured above.   "
221012|NCT00747708|"     The purpose of this study is to determine whether adult bone marrow derived stem/progenitor     cells improve cardiac function and symptoms in patients with heart failure and to establish     the optimal method of delivery of these cells.      Study hypotheses:        -  Administration of G-CSF to patients with heart failure secondary to ischaemic heart          disease will lead to an increase in circulating progenitor cells as measured by          peripheral CD34+ positive cell counts        -  Cardiac function and symptoms will improve in patients in whom the peripheral CD34+          counts increase in response to G-CSF administration        -  Direct coronary injection of autologous bone marrow derived stem cells will confer an          additional improvement in cardiac function and symptoms above that derived from G-CSF          infusion alone        -  Direct intramyocardial injection of autologous bone marrow derived stem cells will lead          to an improvement in cardiac function and symptoms above that derived from G-CSF          infusion alone   "
221013|NCT00747721|"     The study will examine dexmedetomidine levels in the blood of critically ill intensive care     patients to understand how it is broken down by the body.   "
221014|NCT00747734|"     This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A     administered by IV infusion every 3 weeks in patients with locally advanced or metastatic     solid tumors for whom standard therapy either does not exist or has proven to be ineffective     or intolerable. This study will be conducted at up to three study centers in the United     States.   "
221015|NCT00747747|"     The goal of the study is to demonstrate that SINUclean DM® spray, added to the standard     (amoxicillin/clavulanate) therapy of the acute episode of sinusitis (acute, subacute or     chronic), is safe ad capable to determine the resolution of the symptoms in a shorter time in     comparison with the standard therapy without co-adjuvant, or with simple saline lavage.   "
221016|NCT00747760|"     Resistance to thyrotropin (RTSH) is a condition of impaired responsiveness of the thyroid     gland to TSH, characterized by elevated TSH, low or normal thyroid hormone levels, and     hypoplastic or normal-sized thyroid gland.      The aim of the present study was to evaluate the clinical course over time,the     genotype-phenotype association and the frequency of two different TSH-receptor (TSHR)     mutations in a highly consanguineous population of the town of Um-El-Fahem.   "
221017|NCT00747773|"     The purpose of this study is to evaluate the feasibility and general safety in the human     airway as well as assess the safety and depth and area of treatment using liquid nitrogen     sprayed through a catheter via flexible fiber optic bronchoscopy (FFB) using surgical     resection specimens from patients undergoing lobectomy.   "
221018|NCT00747786|"     The purpose of this study, is to assess the safety and local tolerability of the long-term     use of Somatuline Autogel when administered by patients or their partners (Home Injection     Group) and the safety and local tolerability in patients receiving their injection from a     healthcare professional (HCP) (Reference Group).   "
221019|NCT00738127|"     The purpose of this study is to determine a surgical technique is effective in the treatment     of acute dorsal trans-scaphoid perilunate dislocations.   "
221020|NCT00738140|"     The purpose of this study is to discover if intensive lifestyle changes (such as diet and     increased physical activity) improve the body's sensitivity to insulin, and therefore help     prevent diabetes and other cardiovascular disease, in men receiving GnRH hormone therapy for     prostate cancer.   "
221021|NCT00738153|"     This observational study is conducted in Africa. The aim of this observational study is to     evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin     Levemir® under normal clinical practice conditions.   "
221051|NCT00738569|"     The purpose of this study is to determine whether or not adding Raltegravir to a fully     suppressive antiretroviral regimen will assist in reducing HIV-1 associated chronic     inflammation and increase the t-lymphocyte memory cell pool.   "
221052|NCT00738582|"     This research is being done to find out if pemetrexed and cisplatin work better when given     together with an experimental drug called MORAb-009 in patients with malignant pleural     mesothelioma.   "
221022|NCT00738166|"     Trace elements, bioactive secondary metabolites and vitamins are among the most important     quality parameters in plants. Yet, very little information is available on their content,     bioavailability and health effects of organically grown plant food products. The main     objective of the project is to study the impact of different agricultural management     practises relevant for organic farming on the ability of cereal and vegetable crops to absorb     trace elements from the soil and to synthesise bioactive compounds (secondary metabolites,     antioxidant vitamins and phytates) with health promoting effects. Field experiments with a     rigidly controlled design will be implemented together with state-of-the-art analytical     techniques allowing solid conclusions to be drawn on the variability and optimum levels of     bioactive compounds. The multitude of analytical data from plant and soil samples will be     analysed by multivariate statistical methods in order to reveal differences between the     cultivation systems used. Finally, the relationship between bioavailability of the nutrients     studied and the elemental fingerprint of plants will be extracted by the statistical methods.   "
221023|NCT00738179|"     Obstructive Sleep Apnea (OSA) is a condition in which a person stops breathing for several     seconds at a time due to relaxation of the throat muscles. This can occur many times during     sleep. It is known to cause sleepiness and poor concentration during the day. Research     indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its     association with hypertension, stroke, heart attack and sudden death. The standard therapy     for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to     effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly     reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of     SAVE is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for     people with OSA.   "
221037|NCT00738374|"     This single arm study will assess the efficacy and safety of MabThera + chlorambucil as     induction therapy, followed in responders by maintenance therapy or observation in elderly     patients with previously untreated chronic lymphocytic leukemia. During the induction phase     patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses     of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses     of MabThera given every 8 weeks, or no further treatment. The anticipated time on study     treatment is 2+ years, and the target sample size is <100 individuals.   "
221024|NCT00738192|"     Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated     anesthetic induction and maintenance, whereas corresponding pain during awakening influences     patient's rehabilitation strongly. In addition, such early postoperative pain results in     significant stress responses, which displays as further release of stress hormones such as     cortisol and β-endorphin as well. How to prevent such acute pain resulting from     remifentanil's fast metabolism endows clinical significance. This study is designed to     compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after     gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance,     and investigate corresponding influence on the levels of blood cortisol and β-endorphin.   "
221025|NCT00738205|"     This is an international, multicenter study involving children treated with Saizen®, a growth     hormone, who will be trained to use easypod, a new electronic injector and will complete a     questionnaire after 12 week of use.      Both children naïve to growth hormone and dissatisfied with their current injection device     will be recruited.   "
221026|NCT00738218|"     To compare the diagnostic ability of 64-detector MDCT coronary angiography with conventional     invasive coronary angiography in patients with suspected coronary artery disease.   "
221027|NCT00738231|"     This study is an interventional study which was conducted in the field. The investigators     intended to develop an efficient and economically valuable method which can decrease the risk     factors for prevention of cardiovascular diseases. Effective control of cardiovascular     diseases necessitates a salutogenetic approach to develop efficient and cheap methods to     decrease risk factors.      In this study, the aim of preparing the Group II training material was to enable the     individual to see his or her risks as unique, and to proceed with life by adapting personal     behaviors. Group II's training material was formatted as a prescription. Because giving a     prescription for a doctor is very important in low socioeconomical group person.      This study showed that social programs oriented towards individual behavioral changes assume     an important role in decreasing cardiovascular risk factors.   "
221028|NCT00738244|"     Wind-noise is highly disturbing to hearing impaired individuals wearing hearing aids who wish     to participate in outdoor conversations where wind is present or during activities such as     walking or running. In these situations, wind noise significantly reduces signal-to-noise     ratio and, consequently, the intelligibility of speech and sounds may be significantly     impaired. This negative effect is exacerbated with the use of directional microphone schemes     in the hearing iads. The objective of this project is to determine the efficacy of the MH     Acoustics' multi-microphone wind-noise reduction invention for the digital hearing aids     market. MH Acoustics' wind noise reduction technology is unique since it provides     instantaneous convergence while maintaining directionality of the microphone array. Current     commercial technologies do not provide this feature. We are hypothesizing that, due to the     design of the algorithm, speech perception ability and sound quality perception will be     better than that available with traditional directional and/or omnidirectional microphone     schemes in windy environments.   "
221029|NCT00738257|"     The purpose of the study was to evaluate the effect of Pamidronate on bone mineral density     loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A     and glucocorticoid based immunosuppressive regimen.   "
221030|NCT00738283|"     We propose to examine the absorption and excretion of zinc and copper in infants with     ostomies. This will be accomplished by measuring baseline excretion and serum levels of zinc,     copper, and ceruloplasmin, and by utilizing stable isotopes of zinc and copper to measure     absorption and excretion.      To determine how the presence of an ileostomy impacts zinc and copper metabolism in infants     at three time points: 1) when the infant has an ostomy and is receiving the majority of     calories from total parenteral nutrition (TPN); 2) when the infant has an ostomy and is     receiving primarily enteral nutrition without TPN; and 3) when/if the infant has a surgery to     reconnect the bowel and is receiving primarily enteral nutrition.      For the first part of the study, excretion data for zinc will be obtained for ostomy     patients. We hypothesize that infants with an ostomy will excrete more zinc in their stools     than healthy term or preterm infants without ostomies.      For the second part of the study, we will obtain data on zinc absorption, secretion, and     excretion through use of stable isotopes. Jalla et al determined that healthy infants retain     zinc of 0.4 mg/day. We hypothesize that due to increased zinc losses, the infants in the     study will be less positive than the healthy infants in the study by Jalla et al. Our study     is designed to be able to detect if the ostomy patients net retention is one-half that     described by Jalla (i.e. 0.2 mg/d). We will also obtain data on copper absorption, secretion,     and excretion through the use of stable isotopes in the second part of the study. As a pilot     study, we do not fully know what to expect regarding copper levels in infants with ostomies,     but we hypothesize that they may be less positive than healthy infants without ostomies.     Also, we hypothesize that zinc and copper are competitively absorbed in the gut; therefore,     infants who receive more zinc may absorb less copper.      For the third part of the study, we will obtain data on zinc absorption through the use of     stable isotopes after the infant has had surgery to reanastomose the bowel. We hypothesize     that there may be continued zinc losses above those documented for healthy infants who have     never had an ostomy, but decreased losses compared to when the infant had an ostomy.   "
221053|NCT00738595|"     This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of     Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated     to quit smoking. EVT 302 will be compared to placebo both with and without open label     nicotine replacement therapy.   "
221034|NCT00738335|"     RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for     their growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic     radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to     normal tissue. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving     erlotinib together with stereotactic radiosurgery may kill more tumor cells.      PURPOSE: This phase I clinical trial is studying the side effects of erlotinib when given     together with stereotactic radiosurgery and to see how well it works in treating patients     with non-small cell lung cancer with brain metastases.   "
221035|NCT00738348|"     It is reported that sivelstat improved and preserved the postoperative renal function in the     orthopedic management. Moreover because sivelstat reduced the migration of neutrophil, it     improved acute lung injury. During liver resection, Pringle maneuver, clamping the     hepatoduodenal ligament, was performed. Pringle maneuver causes reperfusion injury of the     liver. We have a hypothesis that sivelstat prevent the warm shock of reperfusion injury of     the liver by Pringle maneuver.   "
221036|NCT00738361|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle     formulation works in treating patients with metastatic melanoma of the eye that cannot be     removed by surgery.   "
221038|NCT00738387|"     The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes     the cancer treatment more effective in patients with locally advanced or metastatic non-small     cell lung cancer   "
221039|NCT00738400|"     This is a controlled, randomized, multi-center prospective study of vardenafil to determine     efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic     Syndrome. This study will explore the rate of patients who do need to switch to the highest     dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re     nata)   "
221040|NCT00738413|"     Subjects with thalassemia major require regular transfusion therapy to sustain life. The iron     present in the transfused blood remains in the body where it can cause a variety of organ     dysfunctions. Lifelong iron chelation therapy is needed to maintain iron balance but its     effectiveness varies greatly. Like that of deferoxamine (Desferal, DFO) the mainstay of     chelation therapy for 30 years, the effectiveness of deferasirox (Exjade, ICL670), the newly     approved, orally effective iron chelating drug, is not satisfactory in all subjects. Even     with good compliance, the iron excretion induced by a given drug exhibits wide     subject-to-subject variability. There is often persistent iron overload of extra hepatic     tissues such as the heart and pancreas leading to cardiac disease and diabetes. Combining the     drugs may be a better approach in those subjects at increased risk. The iron balance studies     proposed will permit an assessment of the potential of such a combination to place subjects     in net negative iron balance and the relative effectiveness of the combination in relation to     that of the individual drugs, an additive effect being expected. With such information,     physicians will be able to design individualized chelation regimens that maximize     effectiveness while minimizing side effects by adjusting the ratio and/or the dosing schedule     of the two drugs.   "
221041|NCT00738426|"     The purpose of this study is to determine whether green diode low level laser therapy is     effective for body contouring of the waist, hips and thighs.   "
221042|NCT00738439|"     The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative     adult spinal deformity patients.   "
221043|NCT00738452|"     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as carboplatin, paclitaxel, cisplatin, and etoposide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing     substances to them without harming normal cells. Giving radiation therapy and combination     chemotherapy together before radiolabeled monoclonal antibody therapy may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of radiolabeled     monoclonal antibody therapy when given after radiation therapy and combination chemotherapy     in treating patients with stages I-IIIB non-small cell lung cancer.   "
221044|NCT00738478|"     The aim of the study is to evaluate whether distal gastrectomy without post-operative     nasogastric decompression tube is better in terms of quality of life.   "
221045|NCT00738491|"     The purpose of this study is to identify whether exposure to ambient levels of air pollution     during normal daily activities has a functional impact on patients with coronary heart     disease   "
221046|NCT00738504|"     The purpose of this study is to determine if intensive insulin therapy really reduces the     incidence of acute kidney injury in critically ill patients, using for analysis the RIFLE     criteria for definition of AKI.   "
221047|NCT00738517|"     The purpose of this study is to investigate, if immunoadsorption of autoantibodies with     subsequent substitution of immunoglobulins is able to improve cardiac function of patients     with heart failure after myocardial infarction and presence of cardiac autoantibodies.   "
221048|NCT00738530|"     This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in     combination with Roferon as first-line treatment in participants with metastatic renal cell     cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is     1-2 years, and the target sample size is greater than (>)500 individuals.   "
221049|NCT00738543|"     The investigators have few options for skin antisepsis. Alternatives for povidone-iodine,     which is the most commonly used agent, are costly or ineffective. To have more options, this     study is needed. The investigators want to know if there are difference between the use of     10% sodium hypochlorite or 10% povidone-iodine for skin antisepsis.   "
221057|NCT00738647|"     Evaluation of a new resin-based composite material.      Amalgam and composite are the most commonly used restorative materials in dentistry. Due to     the toxicity of mercury and the subsequent environmental problems, the search for     alternatives continues and search into new composite restorative materials intensifies. The     presently available composites have improved, but shrinkage of the composite during the     curing procedure is still a clinical problem. A new composite restorative material has among     other advantages demonstrated lower shrinkage in laboratory studies, due to a new formulation     of the material.      This project aims to study the clinical performance of this new composite compared to a     commonly used composite restoration material. 72 patients (158 teeth) are allocated to the     project which is carried out at the School of dentistry, University of Aarhus, Denmark.   "
221058|NCT00738660|"     Hypothesis:      The angiotensin receptor blocker telmisartan is effective at reduction of albumin excretion     rate(AER) in patients with type1 diabetes and micro or macroalbuminuria. Dual blockade with     the addition of ramipril an angiotensin receptor blocker gives added efficacy for reduction     of AER. ARB telmisartan gives a 24 hr BP lowering effect.      Summary:      This is an open label cross over study involving 30 patients who were initially treated with     Telmisartan 80 mg for eight weeks followed by addition of Ramipril 10 mg for a further eight     weeks. Albuminuria reduction and BP reduction with both clinic and ambulatory BP records were     studied at the end of each phase.   "
221059|NCT00738673|"     This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12     months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal     treatment in Prostate Cancer patients who experienced PSA-Failure following     gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in     Testosterone levels at inclusion.   "
221073|NCT00738855|"     Mini abstract :      Altogether 100 patients with 117 episodes of ASBO were randomized into control and     gastrografin groups. Eight episodes in eight patients were excluded. Gastrografin group     showed a significant decrease of both the time between admission and operation and that of     hospital stay .The need for surgery was reduced but statistically insignificant.   "
221060|NCT00738686|"     The aim of AUTAX study is to investigate the frequency of MACCE in patients with multivessel     disease and multiple Taxus stent implantations in the real world stenting at 30 days, 6 and     12 months at 2 year follow-up. Because multivessel stenting using DES has been limited due to     economic considerations, the secondary aim is to enhance experience in multivessel stenting     with drug-eluting stents in order to improve short- and long-term outcomes of the patients     with severe multiple coronary artery stenoses.      The objectives of the study are:        1. To determine the frequency of MACCE at 30-day, 6 and 12-month and at 2 year clinical          follow-up after multivessel intervention with drug-eluting stents in a prospective          patient cohort..        2. To determine the rate of in-stent restenosis, target lesion and target vessel          revascularization (angiographic measures) 6 months in patients with multiple DESs in          multiple lesions.        3. To investigate the clinical and angiographic outcomes after implantation of multiple          DESs in the subgroup of patients with accompanying diseases (diabetes mellitus, renal          insufficiency) with known high restenosis and late complication rate.        4. To evaluate potential cost burden in attempting a strategy of complete revascularization          by multiple DES in patients with multivessel disease.   "
221061|NCT00738699|"     The study is being conducted to find out if paclitaxel works better when given together with     an experimental drug called MORAb-003 (farletuzumab) or alone in patients with     platinum-resistant or refractory relapsed ovarian cancer   "
221062|NCT00738712|"     This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies designed     to improve MRI examinations of the vascular structures, abdomen, and pelvis regions.   "
221063|NCT00738725|"     The BioImage Study is a study of the characteristics of subclinical cardiovascular disease,     as measured by imaging modalities, unsupervised circulating biomarker measurements, and risk     factors that predict progression to overt clinical cardiovascular disease, in a diverse,     population-based sample of 7,300 men (aged 55-80) and women (aged 60-80). The     socio-demographics of the study population aims to mirror the US population as a whole with     approximately 69% of the cohort will be white, 12% African-American, 13% Hispanic, 4% Asian,     predominantly of Chinese descent and 2% other (U.S. Census Bureau: 2000).      The cohort will be recruited from the Humana Health Plan membership represented in three     major US markets; Chicago, Illinois, Louisville, Kentucky and Southern Florida. Of the 7,300     participants, 6,000 will be characterized with respect to their Framingham risk score and     various imaging features including coronary calcification, carotid intima-media thickness     (IMT), presence of atherosclerotic plaques, and lower extremity vascular insufficiency as     determined by the ankle brachial index (ABI). Blood samples will be assayed for putative     biomarkers using a variety of methodologies including unsupervised proteomic and metabolomic     profiling of plasma, RNA expression profiling and candidate gene analysis or genome wide     scanning. These approaches will also be combined with targeted assays for particular     analytes. Biological samples will be banked at the time of collection for these analyses and     for additional follow on case-control and validation studies. Participants will be followed     for identification and characterization of cardiovascular disease events, including acute     myocardial infarction and other forms of Coronary Artery Disease (CAD), and stroke;     mortality; and for cardiovascular disease interventions. The remaining 1,300 subjects will be     evaluated and followed in a similar manner except no imaging studies will be conducted.      The study will be conducted using an innovative infrastructure and method of participant     recruitment and enrollment. Mobile clinics containing the imaging equipment will travel to     the three markets included in the study. The mobile clinic configuration allows for a high     level of consistency in the data measurements which will be collected from diverse geographic     areas and populations. Participants will be recruited based on claims monitoring to     pre-determine eligibility. The baseline examinations of the 7,300 participants will occur     over a 12-month period. Based on particular findings (Coronary Artery Calcium (CAC) score,     Carotid Intima-Media Thickness (IMT), atherosclerotic plaque, Ankle Brachial Index (ABI), and     presence of Abdominal Aortic Aneurysm (AAA), approximately 3,000 participants of the 6,000     imaging cohort will be referred for higher resolution imaging modalities to better     characterize their arterial disease. This additional imaging will also be conducted at the     mobile clinics and occur during the same 12-month period. Participants will be contacted     every 6-months throughout the 3-year study to assess cardiovascular events, clinical     morbidity and mortality, and to obtain additional blood samples.   "
221064|NCT00738738|"     This is an open-label, multi-site, 6-month study of an investigational compound in elderly     outpatients, age 65 years old or above, to assess the long-term safety and tolerability of     the compound in the treatment of elderly subjects with Generalized Anxiety Disorder (GAD).   "
221065|NCT00738751|"     The main purpose of the study is to:        -  Determine the safety and tolerability of erlotinib and LBH589B.        -  Establish a recommended phase II expansion dosing of LBH589B and erlotinib in patients          with advanced aerodigestive tract cancers.   "
221066|NCT00738764|"     This is a phase 1, multicenter, open-label, dose escalation trial of PDL192 in subjects with     advanced solid tumors.   "
221067|NCT00738777|"     To investigate prospectively whether short term endocrine treatment can induce molecular     changes, predictive for therapy response.   "
221068|NCT00738790|"     According to the current opinion, local excision in rectal cancer should be limited to     selected T1N0 tumours. The investigators addressed the question whether preoperative     radio(chemo)therapy can expand the use of this procedure for more advanced cancers. The     rationale of preoperative radiotherapy is eradication of mesorectal subclinical disease.     Besides, there is a correlation between radiosensitivity of rectal cancers and low cancer     aggressiveness. For this reason, conversion to abdominal surgery is needed in patients with     radioresistant tumour. The investigators aim to compare the short-course radiotherapy     schedule with the chemoradiation in order to determine an optimal scheme. The study     hypothesis is that the chemoradiation assures 25% more patients who do not require conversion     to an open surgery. In addition, the aim is to asses safety and efficiency of preoperative     radiotherapy and local excision for radiosensitive rectal cancer.   "
221069|NCT00738803|"     The investigators aim to demonstrate the ability to accurately measure and restore leg     length, offset, and center of rotation during a total hip replacement through a new technique     that uses the femoral component as a measurement tool. The operative technique requires     inserting the femoral component prior to performing the femoral neck osteotomy. After the     femoral component is implanted, a reference guide is attached to the femoral component and     guides a screw into the ilium at a fixed distance from the femoral component. The     pre-arthroplasty measurements of leg length and offset are recorded. The femoral neck     osteotomy is performed, and the native femoral head is removed and measured. The acetabular     socket is prepared and the acetabular component is inserted. A repeat measurement with trial     modular neck components is taken and allows the surgeon an additional opportunity to     accurately recreate leg length and offset with the final component. The reference screw is     removed from the ilium and the incision is closed.   "
221099|NCT00739193|"     The primary objective of this trial is to compare the relative hemodynamic effect of a novel     intravenous formulation of amiodarone (PM101), administered as an immediate IV bolus push,     with placebo and with the currentlyl available formulation of Amiodarone IV, administered as     a 10-minute IV infusion, on systolic arterial pressure.   "
221070|NCT00738816|"     Elderly patients have a higher risk of experiencing adverse drug events due to an age related     increase in morbidity and medication use. Inappropriate or wrong medication use among elderly     patients acutely admitted to hospitals is assumed to result in earlier contact to general     practitioner, emergency departments and re-admissions if not corrected during hospital     admission. It is therefore our hypothesis that a systematic medication review conducted by     pharmacists and physicians specialized in pharmacology will increase time to first     unscheduled physician contact (general practitioner, emergency departments, ambulatory care     and re-admissions) after discharge from hospital from an average of 21days to 25 days.     Further, the following secondary outcome parameters will be measured at discharge and within     3-month follow-up:        -  length of in-hospital stay        -  number of contacts to general practitioner 30 days after discharge, that resulted in          medication changes        -  number of re-admissions at 3-month        -  number of death at 3-month        -  number of contact to primary health care at 3-month        -  patients self-experienced quality of health(EQ-5D) 3-month   "
221071|NCT00738829|"     The aim of this study is to determine the maximal tolerated dose level of lenalidomide     combined with fludarabine/rituximab in the therapy of patients with previously untreated     CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide     will be given at the pre-determined maximum tolerated dose in combination with rituximab to     further determine the efficacy and tolerability of this regimen.   "
221072|NCT00738842|"     This study is being conducted to examine the effect of AZD6140 on the levels of certain     chemicals in subjects' blood and urine.   "
223874|NCT00782691|"     Various methods of FDG-PET signal segmentation will be validated by correlation of     histopathologically measured tumor dimensions in lymph node dissection specimens of     head-and-neck cancer patients.   "
221074|NCT00738868|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy     x-rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays     directly to the tumor and cause less damage to normal tissue. Giving cetuximab together with     stereotactic radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how giving cetuximab together with stereotactic     radiation therapy works in treating patients with recurrent squamous cell carcinoma of the     head and neck cancer that cannot be removed by surgery.   "
221075|NCT00738881|"     This randomized phase III trial studies pemetrexed disodium to see how well it works compared     with erlotinib hydrochloride as second-line therapy in treating patients with non-small cell     lung cancer that has spread to other places in the body. Pemetrexed disodium and erlotinib     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. It is not yet known whether pemetrexed disodium is more effective than erlotinib     hydrochloride in treating advanced non-small cell lung cancer.   "
221076|NCT00738894|"     The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE®     HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder plus antiplatelet medical     management is safe and effective and reduces the risk of recurrent stroke or     imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical     management alone in patients with a PFO and history of cryptogenic stroke or     imaging-confirmed TIA.      A co-primary objective is to demonstrate that medical management plus closure with the study     device reduces the risk of new brain infarct compared to medical management alone   "
221077|NCT00738907|"     We hypothesize that quantitative measurements of the beta cell mass within the endocrine     pancreas can be obtained by PET via targeting of vesicular monoamine type 2 transporters with     the radioligand [11C]DTBZ. and that there will be significant differences in [11C]DTBZ uptake     in the anatomical space of the pancreas between normal individuals and those with BCM     predicted to be greater or less than normal based on the measurement of insulin secretion.   "
221078|NCT00738920|"     The primary goal of the proposed trial is to assess the short- and long-term efficacy of     cognitive behavior therapy (CBT) for irritable bowel syndrome using two treatment delivery     systems (self administered, therapist administered). Secondary aims seek to specify the     conditions under which CBT may (or may not) achieve its effects (moderator questions), why     and how these effects are achieved (mediator questions) and at what economic cost. Long term     project goals are to develop an effective self-administered behavioral treatment program that     can enhance the quality of patient care, improve clinical outcomes, and decrease the economic     and personal costs of one of the most prevalent and intractable GI disorders.   "
221079|NCT00738933|"     This randomized controlled double-blind intervention study unravels influence of dietary     plant sterols and stanols on the structure and the sterol composition of the human aortic     valve. The study patients will include 50-60 voluntary patients from the Helsinki Univ.     Central Hospital, who will undergo aortic valve surgery. The patients will be randomized into     plant sterol (E), plant stanol (A) and control (C) groups. Patients in the E and A groups     will be asked to consume daily 2 grams plant sterols or plant stanols, respectively, in a     margarine product.   "
221080|NCT00738946|"     An investigation will be made of the combined impact of insecticide-treated nets and     intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria     morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during     the malaria season in one year and the follow-up will be extended into the second year by     passive surveillance.   "
221081|NCT00738959|"     This study will be performed to evaluate the safety, tolerability and pharmacokinetics of     single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male     volunteers.   "
221082|NCT00738972|"     Evaluate pleiotropic effects of simvastatin in hypertensive patients.   "
221083|NCT00738985|"     To measure the percentage of patients who achieve all the treatment lipid goals being treated     with ezetimibe/simvastatin 10/20 with or without MK0524A (1-2 g/day).   "
221114|NCT00739401|"     The use of a suprarenal extension device during the index AAA procedure to accommodate the     patient's anatomy and to prevent or repair leakage.   "
221084|NCT00738998|"     The goal of this research study is to learn more about what it is like for patients with     breast cancer to receive treatment with the drug anastrozole. Researchers want to learn about     possible symptoms, such as joint pain, that patients may experience during treatment.     Researchers also want to learn more about which patients are most likely to have joint     symptoms by looking at certain proteins from routine blood draw samples.   "
221085|NCT00739011|"     This study is designed to determine the effectiveness of two different CPAP devices. One a     standard CPAP which has the ability to store comprehensive compliance and efficacy data and     the second a auto adjusting CPAP which uses the energy spectrum analysis of flow signals to     automatically adjust CPAP pressure and improve sleep variables.   "
221086|NCT00739024|"     The purpose of this study is to see if ramelteon will reduce the number of migraine headaches     over a 12 week period. The safety and tolerability of ramelteon will also be evaluated.     Ramelteon has been approved by the U.S. Food and Drug Administration (FDA) for insomnia     (trouble sleeping); however; ramelteon has not been approved for the prevention of migraines.   "
221087|NCT00739037|"     The primary purpose of this study is to assess biomarker known as amyloid beta peptide 40     (Ab40) in Cerebrospinal Fluid (CSF), following a single oral dose of PAZ-417 in subjects with     Alzheimer Disease (AD). This study will also consider another biomarker amyloid beta peptide     42 (Ab42) in Cerebrospinal Fluid in subjects with Alzheimer Disease and assess the safety,     tolerability and pharmacokinetic profile of PAZ-417 in both plasma and Cerebrospinal Fluid in     these subjects.   "
221088|NCT00739050|"     Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early     detection of improvement of endothelial function with simvastatin could be a clue for future     intervention trials.   "
221161|NCT00740051|"     Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is     inappropriate (intolerability, contraindication). The second part of the study looks at the     safety of BI 1356 in this patient population with longer term treatment in comparison to a     sulfonylurea drug (glimepiride)   "
221089|NCT00739063|"     The goal of this clinical research study is to learn if Tarceva® (erlotinib hydrochloride)     can help control triple receptor-negative breast cancer. The safety of this drug will also be     studied.      Objectives:      To assess the clinical efficacy, biologic effects and safety of the EGFR inhibitor erlotinib     in the treatment of patients with 'triple receptor-negative' metastatic carcinoma of the     breast.      Primary endpoints:      1) Time to progression (TTP)      Secondary endpoints:        1. clinical benefit rate as defined by complete and partial response and stable disease        2. overall survival (OS)        3. safety profile and tolerability of erlotinib        4. biologic correlative studies   "
221090|NCT00739076|"     Using Virtual Reality as a form of pain control for trauma patients.   "
221091|NCT00739089|"     This is a prospective, observational study to compare presep(tm) catheter central vein mixed     venous oxygen saturation before and after dialysis is initiated via the vascath(tm) central     venous dialysis catheter to evaluate device interaction.   "
221092|NCT00739102|"     A multi-center, non-randomized, single-arm, prospective trial evaluating the safety and     effectiveness of the S.M.A.R.T.™ Nitinol Stent System implantation in approximately 250     patients with obstructive superficial femoral artery disease.   "
221093|NCT00739115|"     The purpose of this study is to evaluate the safety and utility of using heliox gas in     combination with nasal CPAP in premature infants. The investigators hypothesize that using     heliox gas in combination with nasal CPAP will results in decreased early nasal CPAP failure     requiring intubation and mechanical ventilation.   "
221094|NCT00739128|"     Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and     carry a high morbidity rate. It has been recently shown that patients with celiac disease     very often fail to develop immunity after standard vaccination for HBV during infancy. In     this study, we will evaluate whether a second vaccination series via a different route of     administration (into the skin rather than the muscle) results in a better immunological     response in celiac patients. Eligible patients will be randomized to receive a 3-dose     vaccination series into the skin or to the muscle. Rate of responders and level of immunity     will be compared. This study will facilitate better protection of celiac patients to this     potentially deadly virus.   "
221095|NCT00739141|"     The traditional way of doing a donor transplant is to give high doses of chemotherapy and     radiation before giving the stem cells. However, high doses of chemotherapy and radiation can     have serious side-effects. The doctors think that the transplant will be safer and more     likely to be successful with reduced doses of chemotherapy and radiation. The purpose of this     study is to find out how good a combination of chemotherapy and radiation at reduced doses     followed by a cord blood transplant are at treating cancer.      The stem cells chosen for the transplant are from umbilical cord blood. Umbilical cord blood     is collected from healthy newborn babies and frozen. One cord blood collection is called a     cord blood unit. On transplant day, the cord blood will be given through the catheter just     like a blood transfusion. Transplants done this way have been successful. However, this type     of transplant is fairly new. Therefore, it is important to study it so the doctors can better     understand how it works.      Most blood or bone marrow transplants using donor stem cells are done as part of a study.     When patients are on a study we test new ways of treating them which we think may be better     than the old ways. We collect information about the result of this treatment so we can     understand how well the treatment works. This is so we can learn better ways to treat our     patients.   "
221096|NCT00739154|"     since glaucoma is considered an optic neuropathy, new treatments for glaucoma are being     continuously investigated, including neuroprotection.      Previous studies implied that phenytoin, a potent anti-convulsive drug, has a neuroprotective     role, and Na+ channels blockage was suggested as a possible mechanism.      This study predicts that glaucoma patients taking Phenytoin will have a less advanced     glaucoma as compared to patients not taking the drug. Glaucoma severity will be determined by     visual acuity, visual fields, optic disc cupping and nerve fiber layer thickness   "
221097|NCT00739167|"     RATIONALE: Learning about quality of life in patients with cancer undergoing embolization may     help doctors learn about the side effects of treatment and plan the best treatment.      PURPOSE: This clinical trial is studying quality of life in patients undergoing embolization     using yttrium Y 90 glass microspheres for primary or metastatic liver cancer.   "
221098|NCT00739180|"     In this randomized controlled trial, we will examine the effect of a 3-month exercise     training (aerobic exercise versus resistance exercise) without calorie restriction on total     and regional adiposity, and risk of type 2 diabetes in overweight children and adolescents.   "
221100|NCT00739206|"     The objective of the study is to assess the efficacy and safety of SAR97276A in severe     malaria in pediatric patients. Before treating pediatric patients with severe malaria, the     efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric     patients, with uncomplicated malaria.      The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult     and pediatric patients.   "
221101|NCT00739219|"     This study is designed to show that pharmacotherapy guided by eNO and clinical standard of     care produces a superior outcome to trial-based therapy guided by clinical standard of care     alone.   "
221102|NCT00739232|"     This is a single ascending dose study of HSD-016 to provide the initial assessment of the     safety, tolerability, how the drug is absorbed and eliminated, and its effect on the body.   "
221103|NCT00739258|"     It is difficult to detect the intestinal protozoal infections among the HIV-infected persons     or travelers diarrhea by using the traditional microscopy or staining methods. The purpose of     this study aimed at finding out the appropriate diagnostic methods and the infection rate of     the intestinal protozoa, including the Entamoeba, Cryptosporidium and Giardia among the     HIV-infected persons by using the antigen detection method and biological method. The     investigators also tried to analyze the associated HIV infection status and sexual     transmitted diseases (STD) including Gonorrhea, Chlamydial trachomatis, Syphilis, Genital     warts and Herpes simplex virus in this study. The study will collect the blood, urine and     stool samples from 200 intravenous drug user (IDU) with HIV-infected in the prisons, 400     intravenous drug user (IDU) without HIV infected and 100 intravenous drug user (IDU) with HIV     infected receiving methadone maintenance treatment.   "
221162|NCT00740064|"     To evaluate the efficacy and safety of Raltegravir and Epzicom over 48 weeks in ART-naive     HIV-infected subjects.   "
221104|NCT00739271|"     The concept of starting the patient on early enteral nutrition has been a topic of much     interest and research in the past decade. It is gaining widespread acceptance worldwide as     more and more studies are being conducted proving early enteral nutrition to be more     physiological, to prevent morphologic and functional trauma related alterations of the gut     and to modulate immune and inflammatory responses, and as being less expensive than total     parenteral nutrition. Early enteral nutrition is a major component of the recently introduced     post operative rehabilitative regimens.      Early feeding has been shown to reduce the risk of any specific infection, mean length of     hospital stay, anastomotic dehiscence, wound infection, pneumonia, intra abdominal abscesses.     It leads to lower weight loss and early positive nitrogen balance. Hence, overall early     enteral nutrition leads to reduced post operative morbidity and better patient outcome.      The objective of this study was to study and compare the effects of early enteral feeding     with those of conventional management in patients undergoing intestinal anastomosis; the end     points being return of bowel activity, incidence of septic complications, length of hospital     stay, weight loss and post operative morbidity.   "
221105|NCT00739284|"     Kidney obstruction might be caused by a stone in the urinary tract. In case of accompanying     fever or renal failure, an urgent drainage might be needed. This can be done either by     placing an ureteral stent or a nephrotomy tube. Only limited number of studies examined the     question which of the two is preferred. A debate exist regarding the effectiveness of each     procedure to improve symptoms, renal function and treating an infection. Our goal is to     resolve this debate and to state whether one way is preferred on the other.   "
221106|NCT00739297|"     This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast)     compared to placebo on improved lung function in patients with chronic asthma.   "
221107|NCT00739310|"     To asssess efficacy of airway clearance provided by Vest therapy (HFCWO) in the reduction of     respiratory exacerbations requiring hospitalization or antibiotic utilization in patients     with muscle weakness and restrictive lung disease.   "
221108|NCT00739323|"     An observational study to gather information about people who may have certain abnormalities     in skin microcirculation and muscle metabolism and to determine whether these abnormalities     affect wound healing. The study also examines the association of a specific type of cell with     the rate of wound healing.   "
221109|NCT00739336|"     This worksite program for Onondaga County employees is a pilot research study aimed at     decreasing the risk of developing diabetes (or improving metabolic control for adults with     diabetes). The main goal is to improve the nutrition and physical habits of the participants,     and promote weight loss in those who are overweight. The investigators will also examine     factors that predict participation in the program and influence a participant's     outcome/success in the program.   "
221110|NCT00739349|"     Study is to assess the safety and efficacy of NOVA22007 0.05% and 0.1% Cyclosporine     Ophthalmic Cationic Emulsions QD compared to vehicle for the treatment of the signs and     symptoms of dry eye after a 3 month treatment period.   "
221111|NCT00739362|"     This study will determine whether electrical stimulation of an area of the brain called the     dorsolateral prefrontal cortex, which is important in determining the feeling of fullness     after eating, affects how much food a person eats and weight loss over 4 weeks. It will also     compare weight changes in people who attend weight loss counseling sessions and those who do     not over this period of time.      Obese, non-diabetic people between 18 and 60 years of age who are in good health and who live     in the Phoenix, AZ, metropolitan area are eligible for this study. Candidates must have a     body mass index of 35 kg/m(2) or more and weigh less than 350 pounds.      Participants are admitted to the NIH inpatient unit in Phoenix for the first 9 days of the     study for tests, which include meal tests to determine eating behaviors and caloric intake,     blood and urine tests, glucose tolerance test, weight measurement, psychological assessments     and DEXA scan to measure body fat. For 3 of the days, they will be asked to eat all of their     food from automated vending machines. Some subjects receive transcranial direct current     stimulation (TDCS). For this procedure, electrodes that conduct electricity are placed on the     head and arm and the current is turned on for 40 minutes. Some tingling may be felt under the     electrodes. Other subjects receive sham TDCS, with the current turned on only very briefly.      After the evaluations, subjects are discharged home from the NIH unit and instructed to eat     25 percent fewer calories than they consumed while on a weight maintenance diet the first 3     days of their inpatient stay. They maintain the lower calorie diet at home for 4 weeks.     During this period they come to the NIH unit 3 days a week to receive either real or sham     TDCS. Some subjects are also assigned to receive weight loss counseling sessions twice a     week, while others are not. At the end of the 4 weeks, subjects return to the NIH unit for a     5-day stay to undergo a repeat DEXA scan, meal tests, psychological assessment and blood     tests, and they will eat for another 3 days from the vending machines.      At the completion of the study, all participants may choose to receive 4 more weeks of TDCS     or behavioral weight loss counseling, or both.   "
221112|NCT00739375|"     Pulmonary hypertension (PHT) is an elevation of pulmonary arterial pressure (PAP) that can be     the result of heart, lung or systemic disease. PHT also complicates chronic hemodialysis (HD)     therapy immediately after the creation of an arteriovenous (AV) access, even before starting     HD therapy. It tends to regress after temporary AV access closure and after successful kidney     transplantation. Affected patients have significantly higher cardiac output. This syndrome is     associated with a statistically significant survival disadvantage. The laboratory hallmark of     this syndrome is reduced basal and stimulatory nitric oxide (NO) levels. It appears that     patients with end-stage renal disease (ESRD) acquire endothelial dysfunction that reduces the     ability of their pulmonary vessels to accommodate the AV access-mediated elevated cardiac     output, exacerbating the PHT. Doppler echocardiographic screening of ESRD patients scheduled     for HD therapy for the occurrence of PH is indicated. Early diagnosis enables timely     intervention, currently limited to changing dialysis modality such as peritoneal dialysis or     referring for kidney transplantation.An echocardiographic diagnosis of pulmonary hypertension     (PHT) is made when the systolic pulmonary arterial pressure (PAP) exceeds normal values (30     mmHg). In mild PHT, PAP values range up to 45 mmHg, in moderate PHT, PAP is between 45 and 65     mmHg, and in severe PHT, PAP values are greater than 65 mmHg. Systolic PAP equals cardiac     output times pulmonary vascular resistance (PVR), (i.e., PAP = cardiac output × PVR).     Increased cardiac output by itself does not cause PH because of the enormous capacity of the     pulmonary circulation to accommodate the increase in blood flow. Therefore development of PHT     requires pathologic, marked elevation of pulmonary vascular resistance. The presence of PH     may reflect serious pulmonary vascular disease, which can be progressive and fatal.     Consequently, an accurate diagnosis of the cause of PHT is essential in order to establish an     effective treatment program. Pulmonary hypertension can occur from diverse etiologies. In     1996 we first noted unexplained PH in some long-term hemodialysis (HD) patients during an     epidemiologic study of this disorder (Nakhoul F and Yigla M Rambam Medical Cemter-Haifa). It     was assumed that their PHT was related to end-stage renal disease (ESRD) or to long-term HD     therapy via an arteriovenous (AV) access.      There are several potential explanations for the development of PHT in patients with ESRD.     Hormonal and metabolic derangement associated with ESRD might lead to vasoconstriction of     pulmonary vessels and increased pulmonary vascular resistance. Values of PAP may be further     increased by high cardiac output resulting from the AV access itself, worsened by commonly     occurring anemia and fluid overload. Despite almost five decades of HD therapy via a     surgically created, often large, hemodynamically significant AV access the long-term impact     of this intervention on the pulmonary circulation has received little attention.      RD versus AV HD via AV access      Proposed Mechanisms:        1. Elevated Parathyroid hormone        2. Metastatic Calcification due to the increase of the calcium-phosphor multiple        3. High cardiac output        4. Nitric oxide-endothelin metabolism        5. A-v Access flow      These observations indicate a role for AV access-mediated elevations in cardiac output in the     pathogenesis of PH. The correlation between access flow and PAP values has not yet been     studied. Since patients undergoing HD therapy via AV access had PH that reversed after     successful kidney transplantation and after short AV access compression, we concluded that     both ESRD and AV access-mediated elevated cardiac output are required for the development PH.     From a physiologic point of view, due to the enormous capacity of the pulmonary     microcirculation, increased cardiac output by itself cannot cause PH. It is the inability of     the pulmonary circulation of some ESRD patients to accommodate the AV access-mediated     elevated cardiac output that leads to the development of PH.   "
221113|NCT00739388|"     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with     acute myeloid leukemia who are unsuitable for treatment with intensive chemotherapy.   "
221118|NCT00739466|"     The main objective of this study is to assess the safety and efficacy of Liposomal     Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a     population undergoing PCI with implantation of a bare metal stent.      Study hypothesis: Liposomal Alendronate will reduce in-stent restenosis as compared to     placebo.   "
221119|NCT00739479|"     The aim of this study is to compare the effects of two different protein supplements     (partially hydrolyzed whey protein, PHWP vs. partially hydrolyzed gelatin, PHG) on weight     loss in obse individuals with metabolic syndrome (METS). These two supplements will contain     equal amounts of protein but differ considerably in their amino acid contents. Whey protein     is rich in essential amino acids whereas gelatin is rich in proline.      In obese individuals with METS, the hypotheses are:        -  PHWP will augment fat-mass loss and increase lean-mass to fat-mass ration more than PHG.        -  PHWP will improve insulin action more than PHG.        -  PHWP will decrease cardiovascular disease risk more than PHG.   "
221163|NCT00740077|"     This is a single-dose, pharmacokinetic study investigating the bioavailability of flavonoids     and phenolic acids from cranberry juice cocktail and their breakdown products (in vivo     metabolites) in healthy, older adults. Our hypothesis is that the compounds will be poorly     but rapidly absorbed from the intestines and found in plasma and urine in extensively     metabolized forms. These compounds will be rapidly cleared from plasma. Substantial amounts     of unabsorbed compounds will be found in the stools.   "
221178|NCT00740272|"     The aim of the study is to evaluate the impact of atrial fibrillation ablation in patients     presenting a brady-tachy syndrome on the AF burden.      The hypothesis of the study is that AF ablation prevents not only from AF episodes recurrence     but also from bradycardic episodes.   "
221120|NCT00739492|"     In the pilot study, Testing Strategies for Weight Loss, we tested two different approaches     using financial incentives to encourage weight loss. In the first, we built on previous work     showing the effectiveness of 'deposit contracts', in which subjects are given the opportunity     to put their own money at risk if they do not lose weight. In this incentive condition,     subjects received a direct payment conditional on daily weight loss, and an optional     additional payment based on their own contributions to the deposit contract. We matched their     contribution 1:1 to make the option of depositing their own money attractive to this     predominantly low SES population. In the second approach we built on our own prior work using     lotteries to promote drug adherence. In this incentive condition, participants are entered     into a daily lottery, and receive any payoffs they earn from the lottery only if they stay on     track with their weight-loss goal. Given their popularity in the general population,     lotteries hold the promise of providing a cost-effective means of motivating weight loss and     making efforts to lose weight more salient to obese patients. Results from this trial     indicate significantly higher weight loss in the incentive arms of the trial than in the     control group. The low lost to follow-up rates suggest that this approach to providing daily     feedback to keep weight loss salient among participants is feasible. Incentive participants     who completed the study called in their daily weights an average 95.8% of the time. 17/19     (89.4%) of subjects deposited money in their deposit contracts and 14/17 participants who     made initial deposits either held constant or increased their contributions each month.     Subjects in both incentive groups lost significantly more weight on average than subjects in     the control group (4.0 lbs) (lottery 13.1 lbs, p = 0.015; deposit contract 14.0 lbs, p =     0.003). Of the subjects not lost to follow-up in the two incentive arms (32 out of 38), all     of them lost weight.      Based on this promising preliminary evidence and supplemental funding from the Hewlett     Foundation, we propose an 8-month study with 2 intervention arms to further examine the     effect of incentives on long term weight loss success. This study will build on the work to     date to examine which intervention is most successful in promoting sustained weight loss. The     proposed 3-arm extension will enroll 66 participants from Philadelphia VA with BMIs between     30 and 40, starting with those potential participants who were placed on a waiting list for     our previous study after an overwhelming response to the initial mailing.   "
221121|NCT00739505|"     This clinical trial studies the safety, tolerability, and pharmacology of asfotase alfa when     given to adults with HPP.   "
221122|NCT00739518|"     This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as     new hardware or software designed to improve MRI examinations of the brain, spine head and     neck regions.   "
221123|NCT00739531|"     Collection of quantitative data to demonstrate the accuracy (bias) and precision     (repeatability) of the Apieron INSIGHT(tm) eNO Breath System as compared to the FDA cleared     NIOX eNO Breath System when testing is performed by asthma patients.   "
221124|NCT00739544|"     The purpose of this study is to identify intraindividual as well as iatrogenic factors     disposing for the development of chronic and acute pains after surgery for breast cancer in     order to improve treatment and prevent the development of acute and chronic postoperative     pains.   "
221125|NCT00739557|"     The purpose of this study is to look at the systemic inflammatory response caused when     patients undergo thoracoabdominal aortic aneurysm repair (TAAA). In addition, this study will     look at how the inflammatory response affects the post operative healing process and post     operative complications.   "
221126|NCT00739570|"     1. Evaluation of the effect of a chiropractic adjustment (Manually Assisted Mechanical          Force)on        2. surface Static EMG        3. Paraspinal cutaneous temperature        4. Range of Motion        5. Dynamic EMG        6. Blood hormones (Interleukin-6 and C-Reactive protein)   "
221127|NCT00739583|"     Skin preparation solutions are used to clean the skin of the patient before surgery to     decrease the rate of infection. This is particularly important for hip replacement to reduce     the risk of prosthetic joint infection. The use of a mark on the skin for site identification     has become the standard of care to decrease wrong site surgery. The Joint Commission has     mandated site identification as part of the surgical time-out. This procedure is also     mandated by hospital policy.      Preliminary work on cadaveric skin shows that the type of skin preparation can erase the mark     used for surgical site identification. Erasure of the mark presents the surgeon with     difficulty in performing the site identification. Any error or lack of visualization of the     site marking could lead to catastrophic wrong site surgery.      The investigators hypothesis is that chlorhexidine based skin preparation solutions erase     site marking in comparison to iodine based skin preparation solutions. The investigators     intend to prospectively study twenty patients undergoing total hip arthroplasty. Patients     will be randomized to either a chlorhexidine based or an iodine based skin preparation     solution. These solutions are both the current gold standard of clinical care. No differences     have been shown in infection rates for total hip arthroplasty between these solutions. The     site marking will be performed by the same surgeon in a standardized manner. The site marking     will include the surgeon's three initials as per usual routine. Underneath the initials three     random initials will be placed with a horizontal line drawn underneath. The preparation of     the skin will be performed according to the manufacturer's specifications. Digital     photographs will be taken of the skin marking after skin preparation. Photographs of the     three random initials will be de-identified and placed in a Powerpoint presentation form.     Ten orthopaedic surgeons will then read the site markings to identify the random initials and     to tell whether the mark looks appropriate to perform a surgical timeout. The horizontal line     will be digitally analyzed using Adobe Photoshop to quantitatively measure blackness of the     mark.   "
221128|NCT00739596|"     The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination     of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.   "
221129|NCT00739609|"     This study provides an early evaluation of an entirely new class of small molecule agents     directed at disruption or elimination of tumor tolerance, a phenomenon now demonstrated to be     involved in the growth of many solid tumors.   "
221130|NCT00739622|"     The purpose of this study is to investigate the pharmacokinetic interaction between the     combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily.     Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body     and eliminated from the body. Furthermore the short-term safety and tolerability (how well     the body tolerates the drug) of co-administration of TMC278 and ethinylestradiol and     norethindrone, in healthy women, will be assessed.   "
221131|NCT00739635|"     The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in     the treatment of subjective tinnitus in comparison to placebo.   "
221158|NCT00740012|"     Study hypothesis: Waking up in response to an alarm clock may evoke a stress reaction that     leads to rising glucose concentrations.      The purpose of this study was to prove this hypothesis with continuous glucose monitoring     over three nights.      Night (a) with an alarm clock set at 2 h intervals for glucose self monitoring,      Night (b) with a nurse performing blood glucose determinations, and      Night (c) with the patients left undisturbed.   "
221160|NCT00740038|"     Chemotherapy adversely affects quality of life in cancer patients. Both stress management     training and exercise training have been shown to improve quality of life. These two types of     training have not been directly compared for chemotherapy patients.      This study seeks to evaluate the separate and combined effects of stress management training     and exercise training on quality of life during chemotherapy treatment. Participants receive     either a home-based, self-administered program in 1 of 3 types (stress management, exercise,     or stress management + exercise) or usual care (reading materials). It is hypothesized that     the combined program (stress management + exercise) will be significantly associated with     better quality of life than the usual care group, the exercise only group, and the stress     management only group. All participants are assessed at 3 timepoints: before they begin     chemotherapy, 6 weeks after their first chemotherapy infusion, and 12 weeks after their first     infusion.   "
221132|NCT00739648|"     Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent     acute exacerbations (AECB) which are associated with enormous healthcare expenditures and     significant morbidity, specifically an increased risk of death, a decline in pulmonary     function and a significant change in quality of life. Bacteria appear to have an important     role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in     COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In     addition, recent studies indicate that acquisition of a new strain of H. influenzae, M.     catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations.     Chronic inflammation and bacterial infection predispose many patients to frequent and     recurrent acute exacerbations.      Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will     decrease the incidence of acute exacerbations by both by lowering the organism burden, and     resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial     strains.   "
221133|NCT00739661|"     The study was a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical     trial of vismodegib (GDC-0449) in patients with ovarian cancer in a second or third complete     remission. Patients were randomized in a 1:1 ratio to either vismodegib or placebo.     Randomization was stratified based on whether their cancer was in a second or third complete     remission.   "
221134|NCT00739674|"     To evaluate the effectiveness of diet management with a losartan based titration regimen     versus losartan based titration regimen alone on blood pressure reduction in hypertensive     patients.   "
221135|NCT00739687|"     Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a     role in the development and progression of heart failure. The AGE-crosslink breaker     Alagebrium improved cardiac function and symptoms in experimental preclinical and small human     heart failure studies. These results have not yet been confirmed in a randomized controlled     clinical trial. Objective: to evaluate the safety and efficacy of alagebrium in subjects     diagnosed with heart failure. This is a randomized, double-blind, placebo-controlled trial to     assess the effects of 400 mg (2 x 100 mg bid) of alagebrium versus placebo over 9 months. 100     subjects will be studied (50 per treatment group) in approximately 6 centers. Procedures:     exercise testing (VO2 max; the primary variable), ECGs and blood sampling.   "
221136|NCT00739700|"     Blood pressure cuffs (NIBP) are slowly replacing intra-arterial (IABP) measurement as the     standard of care in the medical intensive care unit. There is little data to support this     clinical normalization of deviance. This study aims to correlate NIBP with IABP.   "
221137|NCT00739713|"     The objective is to study the effect of sea buckthorn oil on dry eye.   "
221138|NCT00739739|"     The purpose of this study is to determine whether PD 0299685 is effective in the treatment of     symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain,     urinary urgency and frequency. At the same time assess the drug's safety and tolerability.   "
221139|NCT00739752|"     The goal of this study is to evaluate interventions to increase acceptance of, and follow     through with, hepatitis B virus (HBV) vaccination in patients attending sexually transmitted     disease (STD) clinics. The 1st specific aim is to assess the effect of message-framing on     vaccine acceptance. Framing theory suggests that positively framed messages (i.e., benefits     of getting vaccine) are more effective than negatively framed messages (i.e., dangers of not     getting vaccine) in stimulating preventive health behaviors. Research on Framing Theory and     engagement in health behaviors suggests also that the effects may be moderated by other     attitudinal factors, including perceived risk of the behavior and degree of involvement in     the message. The 2nd aim is to evaluate the effect of provider-based interventions. Prior     research suggests that recommendations by health providers are very important in patients'     decisions regarding acceptance of health care procedures. The 3rd aim is to examine the     effect of the interventions on follow-through with the 2nd & 3rd dose. Patients (18 years and     older) will be recruited and followed from Chicago and Indianapolis STD clinics during     routine medical visits. An audio computer-assisted self-interview (A-CASI) will cover     demographics, risk behaviors, and perceived risk associated with vaccination. Subjects then     will be randomized to receive a gain-framed, loss-framed, or information only message     regarding HBV immunization (also delivered by A-CASI). Upon completion of the message-framing     intervention, subjects will complete additional attitude questions via A-CASI. In addition, a     randomly selected 50% of subjects will be asked questions regarding their intention to accept     free HBV vaccination, enabling us to examine the effects on behavior of asking intention.     Upon completion of the A-CASI subjects will be randomly assigned to one of two provider     intervention conditions: 1. vaccine offered or 2. vaccine recommended. For both conditions     free HBV immunization will be provided by a nurse practitioner. Subsequently, postcard     reminders will be sent and phone call reminders made for follow-up appointments for those     receiving the first and second doses of vaccine. The primary outcome measure is number of HBV     vaccine doses received.   "
221140|NCT00739765|"     This study will examine whether interpersonal psychotherapy is as effective in treating     post-traumatic stress disorder as the established therapies of prolonged exposure and     relaxation.   "
221141|NCT00739778|"     Bacteria that live in the mouth can digest fermentable carbohydrates such as sucrose,     fructose, and glucose to make acid. This acid can cause demineralization of the tooth and     lead to dental caries or decay. Noncariogenic carbohydrate sweeteners, such as sugar     alcohols, can be used to replace fermentable carbohydrates in foods, thereby decreasing the     risk of caries. In order for a sweetener to be labeled as a noncariogenic sweetener, the FDA     requires that when present in food, the food should not lower the dental plaque pH below 5.7     either during or up to 30 minutes after consumption. The purpose of this study is to     determine whether a new developmental sweetener can be fermented by the bacteria in the mouth     and lead to acid production. This will be done by measuring the pH of dental plaque following     consumption of the sweetener.   "
221142|NCT00739791|"     RATIONALE: Learning about changes in DNA over time in patients with prostate cancer     undergoing diet and lifestyle changes may help doctors learn about the long-term effects of     these changes on disease progression.      PURPOSE: This clinical trial is studying nutrition and lifestyle changes in patients with     previously untreated stage I or stage II prostate cancer.   "
221159|NCT00740025|"     This is a prospective randomized study evaluating dosing frequency of gonadotropin     administration in ART cycles.   "
221186|NCT00740376|"     The purpose of this study is to demonstrate that the Uniglide™ Mobile Bearing Unicondylar     Knee System (investigational device)is not inferior when compared to the Uniglide™ Fixed     Bearing Unicondylar Knee System (control device currently cleared) as measured by the     Composite Clinical Success (CCS) endpoint.   "
221187|NCT00740389|"     This is a Phase I, open-label, 3-period crossover trial to investigate the pharmacokinetic     interaction (process by which a drug is absorbed, distributed, metabolised and eliminated by     the body) between TMC125 and fluconazole, and between TMC125 and voriconazole.   "
221188|NCT00740402|"     The purpose of this study is to investigate the process of acquiring a motor skill subject in     post-stroke, comparing them with healthy subjects.   "
221143|NCT00739817|"     Background: Primary ciliary dyskinesia (PCD) is a rare genetic disease characterised by     recurrent respiratory infections and subfertility due to dysfunction of cilia (brushes) of     the lining cells. Undiagnosed and untreated it can result in an irreversible crippling     chronic lung disease. The diagnosis of PCD is a difficult one and involves the complex     assessment of ciliary structure and function. Thus, PCD is under diagnosed and appropriate     preventative and symptomatic treatment may be denied in many patients. In addition, the gene     responsible for PCD is at present unknown, thus preventing pre-natal diagnosis and genetic     counseling.      Working hypothesis and aims: Recently, it has become apparent that the evaluation of nasally     expired nitric oxide (NO) constitutes a simple and non-invasive diagnostic method, which     discriminates between PCD patients, PCD carriers and healthy controls at high rate of     specificity and sensitivity. Testing is simple and last approximately one minute. We have     recently identified a unique isolated Druze population with high prevalence of PCD. The high     frequency of disease places this closed community at a high risk of undiagnosed PCD.      The aim of this project is to use nasal NO measurement as a screening tool to identify     possible undiagnosed cases of PCD and PCD carriers in this high risk Druze population.   "
221144|NCT00739830|"     The purpose of this study is to compare progression-free survival (PFS) of patients with     advanced, recurrent or metastatic endometrial cancer who have received one, but not more than     two, prior lines of chemotherapy either as adjuvant therapy or treatment for advanced     disease, and then when treated with ridaforolimus or the investigators' choice of progestin     or chemotherapy.   "
221145|NCT00739843|"     The purpose of this study is to estimate how quickly cognitive status and functional status     in older patients on hemodialysis declines.   "
221146|NCT00739856|"     Post Traumatic Stress Disorder is a chronic debilitating illness and few treatment options     have demonstrated effectiveness. The study will look at the use of electroconvulsive therapy     for the treatment of Post Traumatic Stress disorder in patients who have not responded to     multiple antidepressants or cognitive behavioral therapy.   "
221147|NCT00739869|"     A silent stroke is a type of stroke that does not produce any severe symptoms, but may     slightly affect memory or thinking abilities. Women who take hormone replacement therapy     (HRT) may have a higher risk of experiencing a silent stroke than women who do not use HRT.     This study will use magnetic resonance imaging (MRI) to determine the prevalence of silent     strokes and other changes in brain tissue in women who participated in the Women's Health     Initiative Memory Study (WHIMS), a study in which women received HRT, either as estrogen     alone or as estrogen and progesterone combined, or placebo.   "
221148|NCT00739882|"     To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic     moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's     Global Assessment (PGA - H&F) greater-than or equal to 3 in subjects not suitable for other     systemic therapies including cyclosporine, methotrexate, and Psoralen-Ultraviolet Light A     (PUVA).   "
221149|NCT00739895|"     Cardiovascular magnetic resonance (CMR) imaging will be used to assess the impact of common     colds and physical training in high-performing athletes. Healthy individuals from the general     public will serve as a comparison group. CMR has previously been shown to accurately assess     cardiac function, edema, inflammation, and injury.      Athletes competing at National level and Developmental Canadian teams will be prospectively     recruited. All participants will have CMR scans at low and high intensity training.     Participants will be re-scanned immediately after clinical evidence of a common cold, as     determined by respiratory and flu-like symptoms. After 4 weeks, a follow-up CMR scan will be     performed. On the day of each CMR scan, electrocardiograms and blood samples will be drawn     from each participant. Blood samples will provide markers of systemic inflammation, such as     leukocyte counts. At each CMR scan, athletes will be asked to describe there recent history     of physical exertion in questionnaires, which will reflect the degree of physical exertion     performed.   "
221150|NCT00739908|"     The purpose of this study is to examine the efficacy of CX157 60 mg administered three times     a day (180 mg daily dose) as compared to placebo in subjects with Major Depressive Disorder     (MDD). Secondary objectives are to evaluate the safety and tolerability and steady state     pharmacokinetic profile of CX157 in these subjects.   "
221151|NCT00739921|"     The objective of this study is to determine whether the amount or type of fungal DNA present     in the nose and home environment can be correlated with the outcomes of the following quality     of life (QOL) instruments: Medical Outcomes Study 36-item Short Form (SF-36) and the     Sino-Nasal Outcomes Study - 20 Questions (SNOT-20).   "
221152|NCT00739934|"     In this study we will measure the concentration of the drug called voriconazole which is used     to fight infections caused by fungus in children who usually are cancer patients and have     their immune system down. Since we know the dose in adults, and we think we know the matching     doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that     goes into the system with what we know works in adults. We give the drug by a needle directly     into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we     draw a little bit of blood at certain times to measure the drug in it.   "
221153|NCT00739947|"     This is an observational study that involves subjects with full-thickness rotator cuff tears     treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The     primary objective of this study is to observe the timing and rate of tendon retear in those     subjects.   "
221154|NCT00739960|"     The purpose of this study is to determine how safe and effective Abatacept is in treating     patients who have progressive pulmonary sarcoidosis.   "
221155|NCT00739973|"     Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in     combination with amlodipine in patients with essential hypertension.   "
221156|NCT00739986|"     Assessment of the number of days' treatment with semapimod necessary for efficacy, as     measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to     severe Crohn's disease (CD).   "
221157|NCT00739999|"     To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in     children and adolescents with heterozygous familial hypercholesterolemia   "
221207|NCT00740649|"     This is a single ascending dose study of HSD-016 to provide the initial assessment of the     safety, tolerability, how the drug is absorbed and eliminated, and it's effect on the body in     Japanese male subjects.   "
221164|NCT00740090|"     This study will evaluate the safety and immune response of children to an experimental     malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an     infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by     certain kinds of mosquitoes. It affects at least 300 million people worldwide each year, with     more than 1 million deaths, mostly among children less than 5 years of age in sub-Saharan     Africa. Malaria is the leading cause of death and illness among the general population of     Mali in West Africa. Increasing drug resistance to P. falciparum and widespread resistance of     mosquitoes to pesticides are reducing the ability to control the disease through these     strategies. AMA1 C1 is made from a synthetic protein similar to a P. falciparum protein. It     is combined with Alhydrogel and CPG 7909, substances added to vaccines to make them work     better.      Children between 1 and 4 years of age who live in Bancoumana, Mali, and are in general good     health may be eligible for this study. Candidates are screened with a medical history,     physical examination, and blood and urine tests.      Participants are randomly assigned to receive three injections (shots) of either AMA1-C1 or a     control rabies inactivated vaccine called Imovax® (Registered Trademark). The shots are given     in the thigh muscle on study days 0, 56 and 180. After each shot, participants are observed     in the clinic for 30 minutes. They return to the clinic for a physical examination six or     seven times between each shot and then four more times over a 9-month period after the last     shot. Blood samples are drawn at several of these visits to check for side effects of the     vaccine and to measure the response to it. The total duration of the study is 21 months.   "
221165|NCT00740103|"     CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients     are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary     objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease     in Crohn's Disease Activity Index (CDAI).   "
221166|NCT00740116|"     The purpose of the study is to determine if a standardized single dose tranexamic acid given     intravenously immediately preoperatively reduces the perioperative bleeding volume and     reduces the need of blood transfusion in women undergoing surgery for advanced ovarian     cancer.   "
221167|NCT00740129|"     The purpose of this study is to demonstrate that patients with Paget's disease of the bone     who had responded to zoledronic acid treatment as participants in the core registration     studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully     treated with a 5mg infusion of zoledronic acid.   "
221168|NCT00740142|"     Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious     than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized,     double-blinded, placebo controlled trial   "
221169|NCT00740155|"     This is part of an ongoing effort to develop a satisfactory dengue vaccine:      Primary objective:      To describe the safety after each vaccination with bivalent and tetravalent formulations of     dengue vaccine candidates.      To describe the immune response after each vaccination of dengue vaccine.   "
221170|NCT00740168|"     Bevacizumab might influence the dynamic vessel function after being administered     intravenously.   "
221171|NCT00740181|"     This study will determine the activity of decitabine, low dose cytarabine (ARA-C) and G-CSF     for patients with myelodysplasia and leukemia.   "
221172|NCT00740194|"     Aromatase inhibition versus estradiol during 1 week   "
221173|NCT00740207|"     The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and     pain following intraarterial injection for peripheral DSA.   "
221174|NCT00740220|"     This trial will test the hypothesis that the 6 minute walk test (6MWT) is not reproducible as     a measure for oxygen desaturation.   "
221185|NCT00740363|"     The major cause of premature death in renal transplant recipients is cardiovascular disease.     Sitagliptin stimulates insulin secretion and inhibits glucagon release, two central     mechanisms in PTDM by interaction with a hormone system (incretins) that just recently it has     become possible to modulate by drugs. Sitagliptin therefore is an interesting additional drug     for the treatment of posttransplant diabetes mellitus in transplanted patients.      The primary objective of the present study is to investigate the effect of sitagliptin on     insulin secretion in renal transplant recipients.      Secondary objectives are to study the effect on insulin sensitivity, fasting blood glucose,     endothelial function, CsA/Tac blood concentrations.   "
221542|NCT00744549|"     The purpose of this study is to determine whether antioxidants (vitamin E, selenium and     lycopene)can change(reduce)prostate tumor size or blood flow to the prostate as determined by     MRI imaging among men on Active Surveillance.   "
221175|NCT00740233|"     The investigators are inviting people with fibromyalgia, IBS, interstitial cystitis, chronic     pain, and other chronic and recurring conditions to sign up and participate in a year-long     Internet-based survey to study the effectiveness of alternative medicine and the interactions     among stress and coping, pain, and treatment outcomes.      The survey is called PROCAIM, which stands for Patient-Reported Outcomes from Complementary,     Alternative, and Integrative Medicine. PROCAIM was developed under a grant to UCLA     researchers from the National Center for Complementary and Alternative Medicine.      This is a web-based study composed of surveys that will recur at intervals over 1 year!      TO ENROLL        -  Log in to our web site: http://www.procaim.org/        -  Register as a New User.        -  Select clinic name: ClinicalTrials.gov.        -  Read and sign the Consent Form.      After participantssign the form with their email address, participants can begin to answer     the first in a series of questionnaires. The system will send participants email reminders at     the time of each scheduled follow-up for one year.      For further information about PROCAIM, please contact:        -  Deborah Ackerman, Ph.D.        -  Department of Epidemiology        -  UCLA School of Public Health        -  Box 951772        -  Los Angeles, CA 90095-1772        -  deborah.ackerman@ucla.edu   "
221176|NCT00740246|"     The objective of this study is to evaluate the safety and tolerability of VIT-45 in the     treatment of Iron Deficiency Anemia   "
221177|NCT00740259|"     Flunarizine is a calcium channel blocker traditionally used for the treatment of vertigo and     migraine. It also has the mechanism of action associated with antipsychotic activity (D2     receptor blockade), but has never been tested as such. The investigators hypothesis is that     flunarizine can be an atypical antipsychotic.   "
221179|NCT00740285|"     Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally     classified as one of the autoimmune rheumatic diseases. The disease is characterized by     thickening and fibrosis skin, affecting vessels and many organs such as the esophagus,     stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still     unknown, but scientists and medical investigators in a wide variety of fields are working     hard to make those determinations. It is known that scleroderma involves overproduction of     collagen.      FLICKMAN et al, in 1973 published an article about the role of lidocaine at     prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production.     Until now, there is only a case series showing the improvement of thickening skin (75%) and     esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a     RCT to prove these findings.   "
221180|NCT00740298|"     Newborns routinely experience pain associated with invasive procedures such as blood     sampling, immunization, vitamin K injection, or circumcision. Prevention of pain is both an     ethical expectation and a professional imperative, as untreated pain has deleterious     consequences including altered pain sensitivity in later childhood and may be related to the     permanent neuroanatomical and behavioral abnormalities as found in animal models. Moreover,     pain is a source of concern and distress for new parents. Yet, pain reducing therapies are     often underused for the numerous minor procedures that are a part of routine medical and     nursing care for neonates. Growing scientific and clinical literature provides evidence for     the effectiveness of natural, non-pharmacological techniques in both animal and human     newborns. This study compares the pain reliving effects of sweet taste to the combination of     sweet taste and warmth.   "
221181|NCT00740311|"     After a dental extraction, the osseous alveoli fill naturally of a blood clot which is     transformed some month later into osseous tissues. Even if the alveolar walls remain intact     at the end of the intervention, the healing always comes along with a physiological reduction     at the level of the site. The reduction of the alveolar crests is a continuous, cumulative     and inexorable phenomenon This reduction entails in the long term aesthetic and functional     damages which complicate the prosthetic rehabilitation of the dental articulate. That the     prosthetic rehabilitation is removable or fixed, implanto-carried or not, it is made more     difficult and less comfortable for the patient. In oral surgery, certain pathologies require     for their treatment the use of materials of filling generating an activity of reduction /     osseous replacement ending in the formation of a physiological calcified neo-tissue. Numerous     products of osseous replacement were already used to realize alveolar fillings to avoid this     inevitable and strongly harmful osseous loss.The purpose of the present study is to quantify     the physiological osseous loss due to the dental extraction with or without filling by a     randomized study and with calibrated criteria of evaluation. The current standard of care is     no filling (healing from the blood clot) and we know the consecutive osseous loss during the     aging. The technique by filling with an osseous substitute is more and more used in Europe     and in Asia because of the decrease of the osseous loss. At first, these substitutes were     constituted by bone grafts (autografts, allografts, xenografts) that tend to be replaced by     synthetic materials. To realize these fillings according to countries, various materials are     used (bovine bone, coral, bio glasses, phosphates of calcium). The most used synthetic     materials are calcium ortho phosphates, the composition of which is close to mineral phases     of calcified tissues. Ceramic of phosphate of calcium and more particularly the Biphasic     Phosphate Calcium (BCP) was already used in numerous clinical applications.We chose as this     study MBCP gel ™, same product beforehand used in 2 clinical studies for which the Nantes     University Hospital was the sponsor.The perspectives of this study are to be able to propose     the systematization of the alveolar filling to be able to decrease the osseous reduction     after an extraction and to be able to propose more functional prosthetic rehabilitation     (improvement of the masticatory power), more aesthetic and comfortable. When we know the     effect of the under nutrition due to masticator difficulties notably at the aged persons, we     measure all the importance of this major problem of Public health.   "
221182|NCT00740324|"     The purpose of this study is to evaluate the safety and efficacy of the additional     administration of scopolamine butylbromide, glucagon or NPO-11 following a single     intragastric dose of NPO-11 during endoscopy in healthy adult men. The safety will be     evaluated based on adverse events and adverse drug reactions (ADRs) observed with NPO-11 +     scopolamine butylbromide or glucagon, and following additional administration of NPO-11. The     efficacy will be evaluated based on changes in the frequency of gastric peristalsis     classification after the initial dose and the additional dose, and on the presence or absence     of gastric peristalsis at each evaluation point.   "
221183|NCT00740337|"     Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death in the     United States. There is no cure and the disease gets worse over time. Although it usually     occurs in people who smoke cigarettes, researchers do not know exactly how smoking leads to     COPD. This study will compare blood and tissue samples from smokers and nonsmokers with and     without COPD to determine why some COPD symptoms occur in some people and not others.   "
221184|NCT00740350|"     The purpose of this study is to determine if women who have chiropractic care, according to     the Logan Basic Protocol for adjusting, during pregnancy have an easier, shorter labor and     delivery as compared to women who haven't had chiropractic care during pregnancy.   "
221189|NCT00740415|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood     flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, dexamethasone, and     chlorambucil, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Giving combination chemotherapy together with     rituximab and bortezomib may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with bortezomib,     doxorubicin, dexamethasone, and chlorambucil works as first-line therapy in treating older     patients with stage II, stage III, or stage IV mantle cell lymphoma.   "
221190|NCT00740428|"     Urinary incontinence is any involuntary loss of urine. During gestation, hormonal and     mechanical factors favor the incidence of urinary loss that may persist after delivery in up     to 50% of women. Gestational urine loss can be prevented or treated during pregnancy with     physical therapy. Pregnancy and delivery have been widely deemed important risk factors that     should be assessed while developing preventive and curative treatments for both female     urinary incontinence and pelvic floor muscle dysfunction. Pelvic floor muscle exercises, led     by skilled physical therapists, can prevent, reduce, or even cure involuntary urine loss as     well as pelvic floor muscle dysfunction. Within this framework, developing a low-cost,     easy-to-perform method for the treatment of urinary incontinence and pelvic floor muscle     dysfunction, with a preventive or curative approach, is considered necessary. The overall     objective of this study is to assess the effects of pelvic floor exercises during pregnancy     on pelvic floor muscles and urinary continence. Secondary aims include determining whether     exercises change pelvic floor muscle function; if changing pelvic floor muscle function     reduces the occurrence of urinary incontinence; developing and applying a manual guide; and     determining whether the physical therapy guide is well accepted, easily understandable and     reproducible.   "
221192|NCT00740454|"     The objective of the EDVIGE study is to determine whether a negative single distal and     proximal leg veins compression ultrasonography safely rules out the diagnosis of deep vein     thrombosis in pregnant and post-partum women with clinical suspicion of DVT.   "
221193|NCT00740467|"     RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, together     with antithymocyte globulin before a donor stem cell transplant helps stop the growth of     cancer and abnormal cells. Giving chemotherapy before or after transplant also stops the     patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune cells and help destroy any remaining cancer and abnormal cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving cyclosporine and mycophenolate     mofetil after the transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well stem cell transplant works in treating     patients with hematological cancer or other disorders.   "
221194|NCT00740480|"     The purpose of this research study is to learn more about the ENTact™ Septal Staple System     device performance and to collect information to support its premarket application.   "
221195|NCT00740493|"     In a French multicenter double blind randomized controlled trial, the main objective is to     demonstrate that, after 6 months of oral anticoagulation for a first episode of idiopathic     proximal deep vein thrombosis, 18 months of warfarin therapy is associated with a lower     cumulative risk of recurrent VTE and major bleeding in comparison with that on 18 months of     placebo. The secondary objectives are: (1) to determine the risk of recurrent VTE after 6     months of warfarin therapy and the presence or the absence of residual lung scan perfusion     defect and the persistence or not of elevated D-dimer test; and (2), to determine the impact     of extended duration of anticoagulation on the risk of VTE after stopping anticoagulant     therapy on a follow-up of 2 years.   "
221196|NCT00740506|"     This study, conducted at the Naval Medical Center in San Diego, CA, will determine if having     vaginal intercourse in the last weeks of pregnancy decreases the risk of having a prolonged     pregnancy. Pregnancies that continue beyond the due date may increase health risks for the     mother and the baby. Although some believe that vaginal intercourse can help start labor in     the last weeks of pregnancy, there is not proof that it works. Some studies showed that     sexual intercourse helped and some that pregnancy lasted even longer for couples having sex.     In addition to exploring the effect of sexual intercourse on time to delivery, this study     will collect information that can be used in the future to predict when labor will naturally     start and the risk for overdue pregnancies.      Women 18 years of age and older in their first pregnancy who are carrying a single fetus with     gestational age before 38 plus 6 weeks may be eligible for this study. Candidates must be     living with their partner in a stable relationship.      Participants are asked to have sexual intercourse about three times per week. They complete a     diary in which they record the times they have intercourse and how they are feeling daily.     The diaries are submitted by mail each week or at the doctor's or midwife's visit until     delivery. The women have a pelvic exam and ultrasound and complete questionnaires about     problems during pregnancy, overall well-being, attitude toward induction of labor, physical     activity, body image during pregnancy, stress and social support, habits at home, and     environmental conditions, such as weather.   "
221208|NCT00747799|"     This study is a phase II clinical study. Recurrence after radiotherapy patients who are     failure of radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC) were     treated by cisplatin and 5-fluorouracil with Sorafenib as first-line treatment. The objective     response(complete response (CR) + partial response (PR)), Disease Control Rate , safety     profile, tolerability will be evaluated according to World Health Organization (WHO)     criteria.   "
221209|NCT00747812|"     The purpose of this study is to evaluate the safety and effectiveness of an implantable     device to treat migraine. There are a significant number of patients who have drug refractory     migraine and alternative therapies are needed.   "
221558|NCT00744757|"     The purpose of this study is to evaluate the response rate of decitabine in previously     treated and untreated Taiwanese participants with Myelodysplastic Syndrome (MDS - a disease     associated with decreased production of blood cells, blood cells are produced but do not     mature normally).   "
221197|NCT00740519|"     This study is conducted in Europe. The main objective of the study is to assess the safety of     self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin     for the first time. The study will also look at the blood glucose control, frequency of dose     adjustment, clinic visits, and time spent training patients to self-titrate.      The objective of diabetes management is to achieve blood glucose levels as close as possible     to normal in order to avoid late stage diabetic complications. Self-titration (where patients     adjust insulin dosage themselves) offers the potential for better blood glucose control than     titration only at clinic visits. In recent years treatment of type 2 diabetes in the United     Kingdom has moved from hospitals to GP surgeries or local clinics. Patients with type 2     diabetes, in general, have not been trained in self-titration to the same degree as patients     with type 1 diabetes. Less experience in self-titration could impact the level of blood     glucose control and outcome for these patients.      Data from this study will be pooled with data from NN304-3714 (NCT00825643) and will be     reported in the final study report for NN304-3714.   "
221198|NCT00740532|"     Aim of the study is to assess the impact on response to Herceptin-based therapy in patients     with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for     several biological factors potentially involved in Herceptin sensitivity.      Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET,     IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN,     KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.   "
221271|NCT00749294|"     The study will be a prospective study of patients presenting with anogenital warts. The     objective are to assess proportion of anogenital warts to the total number of sexual     transmitted infection patients, to quantify direct and indirect cost of illnesses and     psychological burden associated with anogenital warts and to estimate government program     expenditure for the prevention and control and treatment of the STI/anogenital HPV infection.   "
221272|NCT00749307|"     The purpose of this study is to test the hypothesis that dietary supplementation with an     algal source of docosahexaenoic acid (DHA) can improve the heart rate variability in elderly     patients.   "
221199|NCT00740545|"     Standard investigations fail to reveal any apparent cause in 50% of the cases of recurrent     spontaneous abortion. Prothrombotic mechanisms were initially evoked. Factor V Leiden,     Prothrombin G20210A mutation and protein S deficiency are implicated in the meta-analysis of     Rey (Lancet).However, they do not account for a large number of miscarriages.Gris JC and     coworkers (Blood 2004)carried out an open trial, low-molecular-weight heparin versus low-dose     aspirin, in women with one fetal loss and with a constitutional thrombophilic disorder. They     conclude for a benefit action of Low-molecular-weight heparin. There is actually no trials     concerning women with unexplained recurrent abortions and without known thrombophilia.     Nevertheless,aspirin or enoxaparin are often prescribed. It is time to assess these     practices. We therefore initiate a multisite, double blind randomized study, enoxaparine     versus placebo, in women without known thrombophilia, which experienced unexplained recurrent     abortions.   "
221200|NCT00740558|"     Background      The purpose of this study was to examine the heart rate variability (HRV) in the presence or     the absence of pain in the lower back (L5), while receiving chiropractic care.      Methods      A total of 53 healthy participants were randomly assigned to a control, 2 treatment or 2 sham     groups (n = 10 per group). Participants underwent an eight-minute acclimatizing period. The     HRV tachygram (RR interval) data were recorded directly into a Suunto watch (model T6). The     investigators analyzed the five minute pre-treatment and post treatments intervals. The     spectral analysis of the tachygram was performed with the Kubios Software (University of     Kuopio, Finland).   "
221201|NCT00740571|"     Rationale: Often, incurable cancer patients suffer from severe symptoms as (neuropathic) pain     and fatigue with polypharmaceutic interventions as a consequence. Regarding neuropathic pain     in incurable cancer patients, pregabalin has been registered for neuropathic non-cancer pain,     and amitriptyline is not registered for neuropathic pain, but is recommended as the drug of     first choice in the Dutch handbooks of palliative care. As a consequence of an adaptation of     a Dutch law (July 2007) about off-label medication prescription, off-label medication is not     allowed anymore unless a standard or protocol exists. No clinical trials for this patient     group have been published before.      Objective: To compare efficacy, side effects and costs of a strategy with amitriptyline as     drug of first choice versus a strategy with pregabalin as drug of first choice.      Study design: An open label, randomised non-inferiority trial Study population: Incurable     cancer patients with neuropathic pain Intervention: When a patient decides to take part in     the study, he will be allocated randomly to one of the two study groups. A minimisation     algorithm will be used, that balances for the cause of neuropathic pain (tumour related     versus treatment related), type of treatment (ongoing chemo- or radiotherapy versus not     ongoing chemo- or radiotherapy) and institution. Each drug will be prescribed in a step up     procedure. Patients will be followed during 8 weeks.      Main study parameters/endpoints: Neuropathic pain, as measured with the mean VAS and McGill     questionnaire, strategy success, costs per strategy, side effects, quality of life and     concomitant analgesic drugs.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: There are hardly any risks for the patients. The drugs in both arms already are     usual care for the target population. If there is no or a too small effect, the drug of the     other arm will be added, which strategy also is already usual care. All other medication,     except for Tricyclic Antidepressants Drugs (TADs) and Anti Epileptic Drugs (AEDs), as well as     radiotherapy and chemotherapy are allowed. The patient has to visit the hospital 2 times     during the study period. The patient had to fill in a pain diary daily (5 min), cost diary     and EQ-5D every other week (10 min), related questionnaires as HADS, McGill and EORTC-QLQ-C30     monthly (20 min).   "
221202|NCT00740584|"     To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and     herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up     to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this     study.   "
221203|NCT00740597|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation     therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that     needs to be removed.      PURPOSE: This phase II trial is studying the side effects of intensity-modulated radiation     therapy and to see how well it works in treating patients undergoing surgery for stage IB,     stage II, or stage III soft tissue sarcoma.   "
221204|NCT00740610|"     The overall purpose of this study is to examine the safety, tolerability, pharmacokinetics     (how the body processes a drug), and activity of GS-9450 in preventing liver damage due to     scarring, or fibrosis, caused by Non-Alcoholic Steatohepatitis (also known as NASH).   "
221205|NCT00740623|"     The purpose of this study is to evaluate the effectiveness, safety, and tolerability of     carisbamate as add-on therapy for the treatment of partial onset seizures in patients with     epilepsy.   "
221206|NCT00740636|"     The purpose of this study is to determine whether treatment with temozolomide will shrink     small cell lung cancer tumors. Temozolomide is an oral chemotherapy drug that is currently     used to treat brain cancer and melanoma.      As part of this study, we will be doing additional tests that may help us understand how     temozolomide works. First, if there is a tumor sample from a biopsy done in the past, it will     be analyzed for an abnormal gene that may be present in lung cancer. Before starting     temozolomide, a research blood test will be done to look for the same abnormal gene we are     looking for in your tumor sample. Also, before starting temozolomide and every time you have     a repeat CT scan, a research blood test will be done to analyze the number of tumor cells in     your bloodstream.   "
221210|NCT00747825|"     This is an open-label, single dose study for patients 18 years of age or older with confirmed     metastatic melanoma. Up to 12 patients will be enrolled and all will receive an injection of     approximately 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145 administered via IV injection.     The study will consist of a single dosing day followed by a 7-day assessment period and     21-day follow-up period. The total duration of the study from screening to final follow-up     visit is approximately 60 days.   "
221211|NCT00747838|"     Minimally invasive surgical treatment of atrial fibrillation is safe and effective at     controlling atrial fibrillation. The fundamental goal of STAR Outcomes registry is to improve     the understanding of the efficacy of surgical ablation intervention in the treatment of     atrial fibrillation.   "
221273|NCT00749320|"     The purpose of this study is to assess magnetic resonance imaging (MRI) as a tool to track     tumor growth for renal cell carcinoma while the participant is receiving clinical treatment     therapy with sunitinib or pazopanib. An MRI is a sophisticated type of scan that uses     powerful magnets to make clearer images or to focus on detailed medical information in the     participants abdomen and pelvis. This imaging done for this study will use the ASL MRI     technique that allows us to see blood flow changes which possibly may indicated tumor growth.   "
221274|NCT00749333|"     The purpose of this study is to determine how well tolerated and safe AZD8566 is at different     dose levels. This study will also determine how AZD8566 is distributed around the body and     how it leaves the body.   "
221212|NCT00747851|"     This is a prospective in vitro cell biology study of polymorphonuclear leukocyte (PMN)     protein synthesis in response to PAF. PMNs from cord blood of premature human infants at risk     for NEC (birth weight between 501 - 1500 grams) and PMNs from cord blood of healthy term     infants will be isolated and stimulated with PAF, a biologically active phospholipid     implicated in the pathogenesis of NEC. NEC, a disease of prematurity with an incidence of     10.1% of infants born weighing between 501 - 1500 grams, is associated with significant     morbidity and mortality. We will compare the protein synthesis of inflammatory modulators,     including Interleukin 6 Receptor alpha (IL-6R alpha) and Retinoic Acid Receptor alpha (RAR     alpha) proteins to protein synthesis responses already observed in PMNs isolated from healthy     adults. Furthermore, we will characterize the expression and activity of the mammalian target     of rapamycin (mTOR) translational protein synthesis control pathway in PMNs isolated from     preterm and term infants and compare those results with previous observations in PMNs     isolated from adults. This pathway is known to regulate IL-6R alpha and RAR alpha protein     expression in PMNs isolated from adults. We will also follow those premature infants at risk     for NEC clinically to determine which infants develop NEC and what risk factors may be     associated with NEC in this population.   "
221213|NCT00747864|"     S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS)     and is increased in CSF and blood after CNS injury. There are two objectives to this study.     1) To complement our previous study, is urine S100B concentration correlated with gestational     age in infants born at > 28 weeks gestation during the first week of life? 2) Is the urine     concentration of S100B affected by intracranial pathology in this gestational age range?     Elevation of urine concentration of S100B may be an indicator that the infant will develop     serious intracranial pathology and may allow for early initiation of treatment to potentially     decrease morbidity.   "
221214|NCT00747877|"     RATIONALE: Giving chemotherapy and bortezomib before a peripheral stem cell transplant stops     the growth of cancer cells by stopping them from dividing or killing them. Giving     colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells     move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is     then given to prepare the bone marrow for the stem cell transplant. The stem cells are then     returned to the patient to replace the blood-forming cells that were destroyed by the     chemotherapy and bortezomib. It is not yet known whether high-dose melphalan given together     with a second stem cell transplant is more effective than low-dose cyclophosphamide in     treating patients with relapsed multiple myeloma.      PURPOSE: This randomized phase III trial is studying giving high-dose melphalan together with     a second stem cell transplant to see how well it works compared with low-dose     cyclophosphamide in treating patients with relapsed multiple myeloma after chemotherapy.   "
221215|NCT00747890|"     Obstructive sleep apnea (OSA) is one of the most common sleep disorder. There are numerous     conditions that are related to OSA, such as diabetes, cardiovascular diseases, and metabolic     syndrome. If the patient with OSA have large tonsils, soft and largened uvula or flacid soft     palate, one might benefit from operative treatment of OSA. The aim of our study is to find     out whether an operative treatment is effective in mild OSA patients with carefully assessed     anatomical predispositions. Our ultimate goal is to evaluate the effects of operative     treatment in mild OSA itself and in the diseases related to OSA. We measure the     cardiovasculary functions, symptoms, postoperative recovery, antropometry, laboratory tests,     the quality of life, the quality of sleep and the inflammatory system in sleep apnea before     and after the surgery.   "
221216|NCT00747903|"     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a     certain kind of light. When the drug is active, tumor cells are killed. This may be an     effective treatment against skin cancer.      PURPOSE: This phase II trial is studying the side effects of photodynamic therapy using     aminolevulinic acid and to see how well it works in treating patients with skin cancer.   "
221217|NCT00747916|"     The purpose of this study is to evaluate the safety, efficacy, and side effects of the     CryoSpray Ablation(TM) System (CSA(TM) System) to treat neoplastic lesions on the parietal     pleural surface.   "
221218|NCT00747929|"     1. To evaluate the effect of S-2367 on body weight when administered following a 6-week          placebo lead-in period and then a 54-week 800 kilocalorie deficit reduced calorie diet          compared to placebo in healthy obese male and female subjects        2. To evaluate the safety and tolerability of S-2367 during 54 weeks of drug exposure        3. To evaluate the steady-state/trough pharmacokinetics of S-2367   "
221219|NCT00747942|"     The purpose of this study is to improve and analyze the level of physical activity in     immigrant women from the Middle East and Latin America living in Sweden. The investigators     will also investigate if glucose, insulin, and lipid metabolism; stress-related hormone     production; and subclinical inflammatory activity are affected by the intervention. The     follow-up period is 2 years.   "
221243|NCT00748930|"     This is a Phase 4, retrospective chart review of subjects that participated in the ATTRACT     study. Site investigators will conduct a chart review and complete a data collection form.     The purpose of this study is to describe the treatment used and clinical outcomes of these     subjects following completion of the ATTRACT trial up until their most recent assessment by     the treating physicians.   "
221244|NCT00748943|"     Previous research has shown the oxidizing properties and microbiological efficacies of     chlorine dioxide (ClO2). However, no clinical studies have investigated its microbiological     efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the     inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary     periodontal and malodorous bacteria using for 7 days.   "
221275|NCT00749346|"     An open-label phase I-II trial will be performed in 42 patients with pretreated locally     advanced non-small cell lung cancer. The trial is designed to estimate the efficacy and to     determine safety of NovoTTF-100L treatment combined with Pemetrexed for advanced NSCLC     patients. Patients will receive standard Pemetrexed therapy (at 500 mg/m2 iv q3w for 3     cycles) concomitant to NovoTTF-100L therapy (12 hours a day, daily until the end of all three     cycles of Alimta). Repeat treatments with Alimta + NovoTTF-100L will be offered as long as     the patient is stable or responding. If there is a in-field response with progression outside     of the NovoTTF field, Pemetrexed is to be stopped and third line chemotherapy with Docetaxel     is to be initiated (35 mg/m2 weekly, d1, 8, 15, q 28 d).   "
221220|NCT00747955|"     This study will evaluate new assessment tools and equipment and new ways of using existing     tools and equipment in the NIH Clinical Center s Rehabilitation Medicine Department in order     to maximize patients function. The Department assesses and treats NIH patients with chronic     pain, problems in walking or getting around, activities of daily living, performing tasks     needed for jobs or hobbies, communicating and chewing and swallowing.      Children and adults of all ages with disabilities and healthy normal volunteers may be     eligible for this study.      The following kinds of assessments are evaluated in this study:      Assessments of Impairments      Impairments are problems such as loss of movement, weakness or loss of sensation. Assessments     may include measurements of range of motion, strength, sensation, pain, joint stability or     mobility, joint angles, limb and girth, gait, exercise tolerance, stamina, or ultrasound     imaging of muscle and swallowing function.      Assessments of Function and Performance      Functional and performance assessments look at how well subjects perform actions, such as     walking or getting around, dressing, or preparing meals. They may include evaluations of     activities of daily living, leisure activities, fatigue, vocational activity, school     activity, coping skills, and quality of life. The assessments may be done by questionnaires     or interviews and by watching subjects perform the activities.      Assessments of Treatment Techniques      Treatment techniques are assessed by evaluating methods and equipment used to treat patients     with impairments or problems with function. They may evaluate, for example, the use of heat,     cold, strengthening exercises, fitness exercises, TENS units, splinting and orthotics, or     shoe modifications.   "
221221|NCT00747968|"     30 type 2 diabetic patients will be PET-scanned twice ( half of the patients heart-PET, half     of the patients CNS-PET) in random order with infusions of placebo or GLP-1-analogue during     hyperglycemic clamp to uncover the metabolic effects of GLP-1-analogues in perspectives of     intervention of macrovascular late diabetic pathology such as stroke and AMI. Earlier studies     have revealed tendencies towards steady glucose metabolism in the CNS despite fluctuations in     blood sugar when infusing native GLP-1.   "
221222|NCT00747981|"     To access CT Scan as a diagnostic tool for foreign bodies aspiration.   "
221223|NCT00747994|"     Paget's disease of bone is a frequent bone disorder which usually starts after the age of 40     and which is characterized by bone pain and deformities. Although often without any symptoms,     this disease may have severe complications such as fissures, fractures, neurological     compression, or deafness. In some cases, it is a genetic disorder transmitted with a dominant     autosomal pattern of inheritance: one of the two parents carrying the disease transmits it to     his offspring with a risk of 50% for each child. Since 2002, the first gene involved in     Paget's disease of bone is known and 14 mutations of this gene have been published. A study     confirmed that the presence of those mutations was associated with younger age of onset and     more extensive disease. Thus, the knowledge of those genetic factors in the relatives of an     affected individual allows the screening of the patients with a higher risk for     complications, who may benefit from a medical follow up and earlier treatment, in order to     avoid complications. Indeed, Paget's disease of bone may be treated efficiently by     bisphosphonates.      This project aims at identifying and collecting over one year, 15 affected individuals     affected by Paget's disease of bone and the relatives up to the second degree of relativeness     (a total of 100 individuals is expected). The blood samples may be analysed in order to     search for mutations of the previously known gene and/or to search for new mutations on new     genes.   "
221224|NCT00748007|"     This study is to understand the efficacy on language and cognitive function in Down syndrome     patients who take Rivastigmine.   "
221225|NCT00748020|"     Study on two different irradiation schemes in UVB phototherapy for psoriasis. Previous     studies demonstrated a similar clinical effect in erythematogenic and suberythematogenic     irradiation, with less complications in suberythematogenic irradiation. Most of these studies     used both irradiation schemes within the same patient. UVB has a systemic effect on the body.     Our hypothesis is that previous conclusions are incorrect and that the erythematogenic scheme     will result in earlier clearance of the psoriasis.   "
221226|NCT00748046|"     The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry     and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin).   "
221227|NCT00748059|"     The purpose of this study is to determine the cause of low blood pressure in selective     patients who have problems with their involuntary (autonomic) nervous system. These patients     frequently have had symptoms throughout their life, and their disorder might have a genetic     basis. The biochemical, physiological and pharmacological procedures in this study should     help us define the problem and perhaps lead to more effective treatment.   "
221228|NCT00748072|"     The investigators evaluated the effect of pre-biopsy treatment with 1-deamino-8-D-arginine     (DDAVP) on the incidence of post-biopsy bleeding complications. This is a IV phase single     centre, double blind, randomized controlled study in patients, with acute and chronic     nephropathy, undergoing ultrasound-guided percutaneous renal biopsy.   "
221229|NCT00748085|"     The purpose of this study is to evaluate the safety, and tissue effect of the CryoSpray     Ablation(TM) System (CryoSpray Ablation(TM), CSA or cryospray therapy) at multiple     centers to treat malignant airway disease in the lung using liquid nitrogen sprayed through a     catheter via flexible fiber optic bronchoscopy (FFB)   "
221230|NCT00748098|"     The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release     tablets in the treatment of patients with Restless Legs Syndrome and associated sleep     disturbance.   "
221255|NCT00749086|"     This study aims to compare two treatments in subacute (more than 6 week duration)     non-traumatic (usually osteoporotic) vertebral fractures. The two treatments are the     following:        1. Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of          polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement)          through a posterior route through the vertebral pedicles under radiological guidance.        2. Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach          under radiological guidance, into the fractured vertebra a balloon which is inflated          with fluid and creates a cavity. This may restore part of the vertebral height loss due          to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement is          injected with low pressure into the created cavity to fix fracture reduction. The study          will indicate if balloon kyphoplasty is able to restore vertebral height of the          fractured vertebra better than vertebroplasty.   "
221231|NCT00748111|"     Sudden death is a natural death occurring within one hour after the onset of symptoms. It     remains a major public health problem and accounts for 5 to 10 % of the annual total     mortality ie about 300.000 in the United States. Despite community-based interventions,     overall survival remains below 5%. Better understanding of the mechanisms causing sudden     death could allow early identification of high risk subjects and implementation of specific     prevention strategies. The cause of more than 90% of sudden deaths is cardiac with     ventricular fibrillation or fast ventricular tachycardia complicating an underlying heart     disease. Coronary heart disease and its consequences account for at least 80% of sudden     cardiac deaths. Several risk factors associated with sudden death and not with myocardial     infarction have been identified in population-based studies. However, the relationship     between the occurrence of a coronary artery occlusion and the onset of arrhythmia is unclear.     In particular, coronary artery occlusion can be rapidly followed by chest pain, which acts as     a signal and allows identification of patients for emergency reperfusion. However, in some     cases, the coronary artery occlusion is followed by a sudden onset of arrhythmia and sudden     death. Recent data suggest that acute coronary occlusion is caused by plaque erosion or     rupture and is followed by an intense local inflammation and rapid thrombus formation. Our     hypothesis is that the speed of thrombus formation and coronary occlusion determines the     clinical symptoms. Slow and progressive thrombus formation is likely to induce myocardial     pre-conditioning thereby reducing the occurrence of ventricular arrhythmia. In contrast,     rapid thrombus formation followed by acute coronary artery occlusion and ischemia is more     likely to trigger fatal ventricular arrhythmia. During angioplasty procedures, coronary     artery thrombus are aspirated, providing the opportunity for pathological studies. The aim of     the TIDE study (Thrombus and Inflammation in Sudden Death) is therefore to compare the     composition and age of thrombus collected at the site of coronary occlusion in patients with     sudden death due to acute coronary artery occlusion and patients with an acute myocardial     infarction without ventricular arrhythmia. The following hypothesis will be tested : fresh     thrombus is more frequent in patients with sudden cardiac death versus patients with acute     myocardial infarction without ventricular arrhythmia.   "
221232|NCT00748124|"     To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in     the treatment and control of intra and postoperative air leaks following pulmonary resection     via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to     conventional closure techniques (i.e. surgical staples or sutures) will be compared to     conventional surgical techniques alone.   "
221233|NCT00748787|"     The metabolic syndrome represents a constellation of risk factors associated to the abdominal     obesity that includes insulin resistance, lipids alterations, high blood pressure etc.     Several studies support the hypothesis that the intake of soluble fiber might have a positive     effect in the improvement of such of these risk factors.      So that, the aim of this study is to evaluate the efficacy of Ispaghula husk in the remission     of metabolic syndrome in children between 10 to 16 years old.   "
221234|NCT00748800|"     Adolescents are at risk for HIV because of sexual and drug behavior initiated during this     developmental period. Adolescents in the juvenile justice system are at increased risk for     HIV due to higher rates of substance use and psychopathology than their non-offending peers.     Juvenile justice youth may therefore also be less likely to benefit from frequently used     skills based interventions. It appears that emotional lability, frequently found in this     population, disrupts skills learned. This project will implement and evaluate an affect     management HIV prevention intervention for adolescents in a juvenile drug court program.     Affect management and general health promotion interventions will be compared to determine     which intervention best reduces risk behavior among adolescents in the drug court.   "
221235|NCT00748813|"     Annual trial for registration influenza vaccine with the strain composition for season     2008/2009   "
221236|NCT00748826|"     The goal of this study is to implement instruments that would increase the treating     physician's awareness of the necessary tuberculosis screening when starting a new patient on     infliximab (Remicade) therapy who has not reacted sufficiently to disease-modifying     preparations, including methotrexate.   "
221237|NCT00748839|"     Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment,     it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis     recurrence, amputation and death approaching 52 % at one month if no specific treatment is     initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to     permit appropriate management of this rare condition.      During the acute phase of HIT, clinicians and biologists can only suspect this complication     with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive     or specific to confirm or refute thr diagnosis of HIT.   "
221238|NCT00748852|"     The purpose of this study is to evaluate the safety of JTT-302 when administered for eight or     12 weeks in subjects with low HDL-C levels and to determine the effect of JTT-302 on lipid     parameters and CETP activity and mass.   "
221239|NCT00748865|"     To evaluate drop comfort, acceptability, preference and blue profile between two marketed     artificial tears in both dry eyes and non-dry eye patient population.   "
221240|NCT00748878|"     Platelet transfusions are routinely administered during neonatal ECMO, with an average of 1.3     platelet transfusions per day being administered while a patient is undergoing ECMO     treatment. The cause of thrombocytopenia during ECMO largely involves platelet adherence to     the oxygenator membrane. Platelet transfusions carry risks such as infections with bacteria     or yeast, and development or worsening of pulmonary hypertension. It is likely that if fewer     platelet transfusions can be administered during the ECMO run, the cumulative adverse effects     of platelet transfusions would diminish and patient outcomes improve. In order to better     understand platelet function during ECMO, the investigators plan to serially determine the     circulating platelet mass, plasma platelet factor 4 concentration, megakaryocyte mass     (estimated by plasma thrombopoietin concentration), and platelet function as quantified by     PFA100. Any patient on ECMO will be eligible for this pilot study of 5 patients. By     understanding changes in platelet function, we hope to design a future study that may modify     the frequency or need for platelet transfusions during ECMO.   "
221241|NCT00748891|"     This study is being carried out in patients with advanced solid tumours to assess which of     two different types of imaging scans best measures activity of an experimental drug called     Cediranib. The study compares the imaging tests: Dynamic Contrast Enhanced CT (DCE-CT) and     Dynamic Contrast Enhanced MRI (DCE-MRI). It looks at which of these scans is the most     accurate and best predicts a response to the treatment. Cediranib is thought to work by     stopping blood flow to cancers, and both of these scans assess blood flow. Studying the     response of cancers by measuring changes in their blood flow may provide useful information     that will guide the way we manage cancers in the future.   "
221242|NCT00748904|"     The purpose of this study is to evaluate patients with cirrhosis of the liver and renal     failure and determine if the administration of rifaximin as compared to lactulose is     associated with less frequent and/or slower progression to severe hepatic encephalopathy. If     one is associated with lower blood ammonia levels. And, if one is associated with lower     breath hydrogen and methane levels.   "
221276|NCT00749359|"     This study is to determine if controlled release paroxetine tablets manufactured at two     different sites behave similarly in healthy volunteers.   "
221245|NCT00748956|"     There is growing evidence that neuropeptides act as neuronal messengers in the brain and have     diverse functions that may include the regulation of mood and behavior. For example,     neuropeptide Y (NPY) is thought to play a role in the adaptive stress response. The     therapeutic application of neuropeptides for psychiatric disorders has been limited by     difficult and unreliable penetration of the blood-brain barrier (BBB). However, recent data     suggest that intranasal administration may provide a means of effectively delivering some of     these neuropeptides to the brain. Thus far it is unclear if this is the case for NPY. The     aims of this project are:        1. To evaluate, in 15 healthy male volunteers aged 25-45, the effect of intranasal NPY          administration (0, 50 and 100 nmol) on its levels in cerebrospinal fluid (CSF), measured          by means of lumbar puncture using an intraspinal catheter between L4 and L5, and in          plasma, measured using an intravenous catheter in the forearm. One of the three          treatments will be administered to each participant in a double-blind fashion. The 0          nmol condition will serve as the placebo control.        2. To test the effect of intranasal NPY administration on mood and anxiety.   "
221246|NCT00748969|"     The purpose of this study is to determine whether growth hormone is a safe and effective     treatment for short stature in children with Mucopolysaccharidosis type I, II, and VI.   "
221247|NCT00748982|"     To explore if AZD1305 compromises left ventricular performance in patients with left     ventricular dysfunction   "
221248|NCT00748995|"     This is a research study examining health effects of the Iraq War, especially those effects     involving mental health. This study is a follow-up to the Neurocognition Deployment Health     Study (NDHS), also called Prospective Assessment of Neurocognition in Future Gulf-deployed     and Gulf-nondeployed Military Personnel: A Pilot Study. The specific purpose of this     research study is to find out more about the longer lasting effects of war on mood and stress     symptoms, thinking and reaction skills, and different aspects of day to day life, such as     work and daily activities. Survey and test results from previous participation in the NDHS     will be compared to the new information that will be obtained from participants as part of     this study. The investigators expect that a total of about 817 military personnel and     military Veterans will participate in the study. There are two parts to this study: (1)     mail/internet/phone survey and (2) in-person assessment. The investigators will invite all     NDHS participants who deployed to Iraq to participate in the survey component. The survey     component of the study involves being interviewed by phone about mood and stress symptoms and     head injuries and completing written survey questions by either mail or on the internet that     address basic personal history (such as age, military status, gender, combat injury history),     mood, stress symptoms, and stressful experiences. The phone interview will take about 2 to     2.5 hours to complete. The questionnaire part will take about 20 to 30 minutes to complete,     and can be completed either by mailing back completed questionnaires or by internet using a     private, individual log-in/password combination. The investigators will invite approximately     200 selected at random from the larger group of survey responders to take part in the     in-person assessment. The in-person assessment involves taking a small subset of     neuropsychological tasks. The tasks will be given on a computer or using paper and pencil.     Participants will also be asked to complete questionnaires about work, daily activities, and     health history, as well as basic health measures such as height, weight, blood pressure,     heart rate, and waist size. Potential participants will be given the option of completing the     in-person assessment at one of the two study sites (Seattle or Boston), or in a private     setting in their community (e.g., a hotel small conference room). Altogether, this part of     the study will take about 120 minutes to 140 minutes to complete.   "
221249|NCT00749008|"     The purpose of this study is to assess the predictive value of generalized movements in     preterm and term infants who are at risk for development of cerebral palsy. The investigators     will identify at-risk infants and observe their generalized movements, conduct a two year     longitudinal follow-up, and interpret the predictive value of the investigators assessments     based on the diagnosis of cerebral palsy.   "
221250|NCT00749021|"     This is a multicenter, randomized, open-label study. 40 patients will be followed for a     period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg     of intravitreal ranibizumab injection.   "
221251|NCT00749034|"     Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing     BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against TB for     residents in endemic areas and persons at risk in non-endemic areas. The new live vaccine     VPM1002 should be at least as potent as the currently used BCG vaccine and should cause fewer     side effects (Kaufmann, 2007; Grode et al., 2005). It is formulated as lyophilised bacteria     to be resuspended before intradermal injection. First application of VPM1002 in human male     volunteers will evaluate its safety, local and systemic tolerability as well as its     immunogenicity. The study has a dose-escalating sequential design with comparison to     commercially available BCG. 80 volunteers in Germany will randomly be allocated to 4 groups     each with 20 volunteers stratified for their history of BCG-vaccination.   "
221252|NCT00749047|"     Pioglitazone is an insulin sensitising drug used in the treatment of patients with type 2     diabetes. In addition to its blood sugar lowering effect, pioglitazone also has a number of     other beneficial effects, one of which is to reduce the loss of protein in the urine. The     mechanism of this protein sparing effect of pioglitazone is not fully understood. The     proposed study will investigate whether pioglitazone has beneficial effects on the filtration     characteristics of filters in the kidney that are responsible for retaining protein in the     body. The effect of pioglitazone on the size of the pores in the filters and also the     electrostatic charge barriers that surround these pores will be investigated. The clinical     study will involve 12 patients with type 2 diabetes with minimal urine protein loss, taking     low dose pioglitazone for 3 months. Blood and urine samples will be collected at the     beginning, mid point and end of the study and used to measure the concentration of specific     proteins of different size and electrostatic charge. This data will be used to identify and     characterise changes in the filtration properties of the kidney filters during the study.   "
221253|NCT00749060|"     This study aims to compare three treatments in recent (less than 6 week duration)     non-traumatic ( usually osteoporotic) vertebral fractures.   "
221254|NCT00749073|"     This is a single-center, open label, prospective clinical study to assess the clinical     application and functional outcomes of symptomatic patients undergoing the Minimally Invasive     Lumbar Decompression (MILD™) treatment for lumbar spinal stenosis. In this study,     patient-reported outcomes over a 3 month period following treatment will be collected by the     investigator. Periodic surveys for each study subject's pain, functional status, quality of     life and physical examination will track outcomes following MILD™ treatment.   "
221256|NCT00749099|"     The overall purpose of this research is to demonstrate (or measure) the intestinal     availability of lipase, amylase, and protease (enzymes the body has a shortage of) from     PANCRECARB® when administered with a meal.   "
221257|NCT00749112|"     The purpose of this study is to determine whether the combination of low doses of alemtuzumab     and rituximab are effective in the treatment of patients with autoimmune cytopenias who has     failed on steroids, relapsed after steroids withdrawal or required continuous steroids     treatment.   "
221260|NCT00749151|"     An estimated 47 million adult Americans smoke. The American Lung Association has launched a     reactive telephone help line to assist in smoking cessation. The proposed study will evaluate     its effectiveness in a randomized controlled trial design involving active smokers who call     this helpline. Eligible callers will be randomized into two groups: those who receive     self-help literature only (i.e. control group) and those who receive additional reactive     telephone counseling (i.e. study group). Detailed information will be collected proactively     by an independent research calling specialist from all subjects who enroll into the study, by     way of follow-up telephone calls, at one, three, six and twelve months following the screen     date. The outcome measures to be compared are abstinence rates, quit attempts, changes in     extent of smoking and behavioral stage, and cost-effectiveness. A thousand subjects will be     enrolled in the two study arms in equal numbers over a period of fifteen months. Intent to     treat analysis will be used after adjustment for covariates. The significance of this study     lies in establishing the public health importance of such a reactive telephone helpline as a     low intensity and low cost interventional smoking cessation tool.   "
221261|NCT00749164|"     Now it is commonly accepted that MSC produce an immune-tolerant environment in different     settings. It has been shown (mainly for BM-MSC) that MSC can down-regulate T cells     activation. This characteristic of BM derived MSC already has clinical implications and shows     their potent effectiveness both in prophylaxis and treatment of resistant GvHD. Ongoing     clinical trials of use bone marrow MSC for treatment of steroid resistant GvHD are     successfully run on and some bone marrow donor registries included BM-MSC as a material for     donation. According to our preclinical studies MSC from cells from marrow, placenta,     umbilical cord vessels demonstrate similar pronounced immunosuppressive effect both with     autologous and allogeneic lymphocytes. Our preliminary clinical experience shows that BM-MSC     is an effective tool for treatment of steroid resistant GVHD. Present study aimed to     demonstrate if human UC-MSC has in vivo immunosuppressive effect and can be used for GVHD     treatment   "
221262|NCT00749177|"     1. Purpose             1. Provide a culturally sensitive and supportive treatment environment for children,               youth and families in the aboriginal community experiencing stress, anxiety and               depression.             2. Gain insight into understanding of the role of Traditional Healing options provided               by Aboriginal Healers and Helpers in the management of stress, anxiety and               depression.             3. Encourage Aboriginal and First Nation clients to seek treatment earlier from a               culturally supportive system.        2. Hypothesis      This will be a descriptive hypothesis generating research project, however it is anticipated     that members of the Aboriginal community experiencing stress, anxiety and depression may     experience improved care and outcomes if their treatment includes traditional healing     methods. A number of measures of subject and treatment characteristics, stress, anxiety and     depression will provide the foundation for triangulation of outcomes in order to describe the     impact of the various treatment options (standard care, Traditional Healing, combined     standard care and Traditional Healing).   "
221263|NCT00749190|"     The objective of the current study is to investigate the efficacy, safety and     pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on     therapy to on going metformin therapy in patients with T2DM with insufficient glycemic     control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM)     as add-on therapy to metformin.   "
221264|NCT00749203|"     The objective of the proposed study is to test if a single IV dose of ketamine (0.5 mg/kg)     decreases symptoms of PTSD.   "
221265|NCT00749216|"     The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK)     and pharmacodynamics (PD) of multiple dosing Solanezumab in subjects with mild-to-moderate AD     in Japanese population.   "
221266|NCT00749229|"     Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL     classification) may undergo unpredictable secondary displacement. Such fractures require a     two session surgery with a first operation carried out immediately to achieve posterior     fixation and a second surgery which is performed some days later to stabilize the anterior     spine and restore stress resistance.      Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore     anterior spine strength and replace second session surgery.   "
221267|NCT00749242|"     This study will compare two treatments in acute stable traumatic vertebral fractures (types     A1, A2 and A3.1 in MAGERL Classification). The two treatments are the followings:        1. Conservative Orthopedic Management consisting of brace and pain medication.        2. Percutaneous Balloon Kyphoplasty, a variant of Vertebroplasty, in which a balloon is          first placed into the fractured vertebra and inflated with fluid in order to create a          cavity. This may restore part of the vertebral height loss due to the fracture and          facilitate the injection of the cement with low pressure.      The primary outcome will be the variation in the angle of Regional Vertebral Kyphosis (or, in     the case of asymmetrical fractures, the angle of lateral vertebral inclination) between     inclusion and one year follow-up. It will indicate if Balloon Kyphoplasty is able to restore     vertebral height of the fractured vertebra better than Conservative Orthopedic Management.   "
221268|NCT00749255|"     The purpose of this case collection effort is software design by R2 Technologies, Inc., The     information received from Women's Imaging will be provided to the Case Collection, Data     Management and Algorithm/software design and development teams who are responsible for the     receipt of patient data and management of such data; and creation, testing and validation of     R2 Technologies, Inc., for Computer Aided Detection (CAD) and new digital image archiving     software design.   "
221269|NCT00749268|"     The objective of this study is to assess pain that occurs following hernia repair that is     related to mesh fixation. The study is designed to see if there is any difference in pain     after surgery between absorbable and permanent methods of mesh fixation in inguinal and     ventral hernia repair.   "
221270|NCT00749281|"     Serum NGAL has been described as a biomarker of neutrophil activation and an inflammatory     marker which correlates to obesity and its metabolic complications. Since neutrophil     activation has been implicated in the pathogenesis of coronary artery disease, the     investigators hypothesized that serum NGAL levels would be higher in patients with CAD and     that serum concentration would correlate with the extent of CAD as documented by coronary     angiography, serving as a potential biomarker of the severity of CAD.   "
221277|NCT00749372|"     A known risk of red blood cell transfusions is that it puts excess iron into the patient's     body. Researchers are continually seeking the most effective method of measuring iron     concentration. The purpose of this study is to determine how much iron has been deposited in     a patient's heart and liver as a result of having received red blood cell transfusions using     magnetic resonance imaging (MRI).   "
221278|NCT00749385|"     A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments,     each containing one or both components.   "
221279|NCT00749398|"     This is a national, multi-center, observational, prospective photographic atlas study in     subjects who are treated with infliximab for moderate-to-severe psoriasis in daily clinic     according to local country regulations and reimbursement.   "
221280|NCT00749411|"     The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the     combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.   "
221281|NCT00749424|"     The objective of this study is to compare the safety and effectiveness of two different     approaches to treat bifurcational lesions with CYPHER SELECT™ Sirolimus-eluting     Balloon-expandable Coronary Stent , Cordis Corp): a) the crushing technique to stent both     branches vs. b) a provisional T stenting technique of the side branch.   "
221282|NCT00749437|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Placing gold     markers in the area where the tumor was removed may help doctors better direct radiation     therapy and help reduce the risk of cancer recurrence.      PURPOSE: This phase I trial is studying how well radiation therapy using gold markers works     in treating women with early-stage breast cancer.   "
221283|NCT00749450|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and capecitabine,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. It is not yet known which combination chemotherapy regimen is     more effective in treating patients who have undergone surgery for high-risk colorectal     cancer.      PURPOSE: This randomized phase III trial is studying chemotherapy given after surgery in     treating patients with high-risk stage II or stage III colorectal cancer.   "
221284|NCT00749463|"     To evaluate the safety, smoking cessation and reduction rate during 3 months of active     nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital     physicians and staff who are motivated to quit   "
221285|NCT00749476|"     The purpose of this study is to collect data around the period of the conversion from     plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a     retrospective history of the bleedings in the 3-month period before the conversion, the     recovery with pdFIX just before the conversion and with BeneFIX just after the conversion,     and a prospective history of the bleedings in the 3 month period following the conversion.   "
221286|NCT00749489|"     The purpose of this study is to compare two different methods of treating pain after a hip     fracture.   "
221287|NCT00749502|"     This is a four-part dose-escalation and confirmation study in participants with advanced     solid tumors. Part A is for dose escalation and determination of maximum tolerated dose (MTD)     and recommended Phase 2 dose (RP2D) of MK-4827. Part B is a prostate/ovarian cancer cohort     expansion. Part C is for a cohort of participants with relapsed or refractory T-cell     prolymphocytic leukemia (T-PLL) or chronic lymphocytic leukemia (CLL). Part D will be for a     cohort of participants with locally advanced or metastatic colorectal carcinoma (CRC),     persistent or recurrent endometrial carcinoma, locally advanced or metastatic triple negative     or highly proliferative estrogen receptor positive (ER+) breast cancer, or partially     platinum-sensitive epithelial ovarian cancer. The study is also designed to find out whether     MK-4827 causes at least 50% inhibition of poly adenosine diphosphate ribose polymerase (PARP)     enzyme activity.   "
221288|NCT00749515|"     This purpose of this study is to understand the differences between people who have a good     response to deferasirox (exjade) compared to people who have a poor response to this     medication when used for transfusion-dependent iron overload.      The hypothesis is that patients with poor responses have physiologic barriers to deferasirox     that may include absorption, pharmacokinetics of drug metabolism, hepatic clearance and/or     genetic factors.   "
221290|NCT00749541|"     decreased vitamin d levels are associated with increased inflammatory markers,and renin     angiotensin levels.      decreased levels were also found to be connected to increased cardiovascular mortality.      we therefore hypothesise that in patients with pathological results of coronary     catheterization we will find decreased levels of 25 hydroxy vitamin d.      we will examine patients undergoing elective coronary catheterization and compare two groups:     those with normal results and those with pathological results.   "
221291|NCT00749554|"     The purpose of this randomized controlled trial is to evaluate the effectiveness of Disc     Biacuplasty in relieving pain, reducing medication intake and improving function,     satisfaction and quality of life of patients with chronic mechanical discogenic low back     pain.   "
221292|NCT00749567|"     The purpose of this study is to evaluate the efficacy and toxicity of combination of     erlotinib and bevacizumab in patients with locally advanced or metastatic, non-squamous     non-small cell lung cancer, who progressed after first line treatment. Pretreatment with one     of the two agents would not excluded patients from the study, in order to evaluate whether     the combination of the two biologic agents could reverse tumor resistance.   "
221293|NCT00749580|"     The purpose of this study is to determine whether raltegravir 400 mg b.i.d. in a boosted PI     regimen is as efficacious and safe as the NRTI backbone in a boosted PI regimen.   "
221304|NCT00749723|"     The purpose of this study is to improve overall survival while maintaining a good quality of     life in pediatric patients with refractory or recurrent brain tumors (medulloblastomas,     supratentorial PNETs, ependymomas WHO grade II and III). Response to different chemotherapy     options (intravenous versus oral chemotherapy, intraventricular chemotherapy) as part of a     multimodal therapy will be assessed. Progression-free, overall survival and toxicity will be     evaluated additionally.   "
221362|NCT00750503|"     Tata Memorial Hospital has initiated Workplace Tobacco Cessation and Oral Cancer Screening     Programme in Chemical Industry at Khed, Ratnagiri. Appropriate interventions for tobacco     cessation will be carried at monthly intervals for twelve months duration. The tobacco     cessation rates based on history will be validated with the urinary cotinine levels.   "
221294|NCT00749593|"     Congenital Adrenal Hyperplasia (CAH) is one of the commonest inherited diseases, affecting     1:14,200 live births. It is the result of a genetic defect in one of the enzymes (in most     cases 21-hydroxylase) required for cortisol biosynthesis, leading to reduced levels of     cortisol and aldosterone, increased ACTH concentrations and consequently increased adrenal     androgen production. Patients suffer from problems with growth and development and as adults     patients may have problems with fertility, virilisation in women, testicular masses in men     and both men and women have an impaired quality of life. Patients have to take life-long     therapy. Despite its frequency knowledge surrounding the management of adults with CAH     remains fairly limited. There has been a lot of work describing the management of children     with CAH but to date there is no consensus on how to manage adults. To address this issue a     number of adult endocrinologists in the UK under the auspices of the Society for     Endocrinology have established a country wide study (CaHASE) to undertake research in order     to set standards of care for adult patients with CAH.      In CAH the severity of the symptoms experienced by affected individuals varies depending on     the mutation and the genetic background of the individual. The ability to tailor CAH therapy     on an individual basis, as determined by the severity of the underlying defect and an     understanding of the likely natural history of the disease, is a key goal in clinical     management. Correlation of phenotype (clinical status) and genotype (the underlying 21     hydroxylase gene mutation) will facilitate stratification of severity and provide an     important contribution to the debate on potential mechanisms of individualised therapy. For     instance it may become clear that certain CAH genotypes are associated with specific long     term outcomes. In time, this could lead to suggesting different treatment strategies in     certain groups. Moreover, genotype data are important if we are to address the relative     contribution of environment (e.g. treatment) vs. genetics on long term outcomes.      This multi-centre study aims to:        1. - Investigate the medical health of adults with congenital adrenal hyperplasia.        2. - Investigate the relationship between the genotype of the patient and the phenotype.        3. - Investigate the quality of life of adults with congenital adrenal hyperplasia.   "
221295|NCT00749606|"     The purpose of this study is to determine if primary care based, telephone-delivered weight     loss interventions are effective.   "
221296|NCT00749619|"     Addition of Heparin to the Catheter Lock Solution (CLS): Taurolock-TM will improve the     vascular patency compared to Taurolock-TM alone , in hemodialysis patients with Tunneled     Cuffed Catheter(TCC) as vascular access.   "
221297|NCT00749632|"     The purpose of this study is to determine the safety of three doses of oxybutynin for the     treatment of urge urinary incontinence.   "
221298|NCT00749645|"     This is a Clinical Pilot Phase II interventional, double blind, randomized and placebo     controlled study to document the efficacy, tolerability and safety of FANG(30) in 60 adult     patients affected with active Rheumatoid Arthritis. Also, to evaluate the effect of an     andrographolide natural formula, identified as FANG(30) or the study product, on the     immunological functions that influence chronic inflammatory process in these patients, who     could benefit with this treatment.   "
221299|NCT00749658|"     The objective of this proposal is to elucidate effects of bupropion SR + varenicline on     smoking-cessation related processes in early abstinence using a human laboratory model. A     within-subjects design will be used to assess the additive effects of bupropion and     varenicline in 48 treatment seeking smokers [bupropion SR (300 mg/day)+placebo, varenicline     (2 mg/day+placebo, and bupropion SR (300 mg/day)+varenicline (2 mg/day)]. Outcomes include     withdrawal and craving, cognition, stress tolerance, anxiety, the reinforcing effects of     smoking, and smoking topography.      Hypotheses: We hypothesize that greatest treatment effects will be observed in the bupropion     SR+varenicline group followed by varenicline+placebo and bupropion SR+placebo groups.   "
221300|NCT00749671|"     BACKGROUND Physician-guided moderate sedation, administered by a Registered Nurse has been     the standard of practice for patients undergoing a wide range of electrophysiology procedures     during the past decade. Currently a subjective sedation assessment tool is the standard of     practice within the Electrophysiology Lab (EP Lab). Bispectral Index monitoring (BIS) is an     objective measure of the depth of sedation presently employed at Baystate Medical Center in     the Intensive Care Unit and within the department of anesthesia.      AIM The aim of this research study is to assess the utility of BIS monitoring in measuring     the depth of sedation in patients undergoing defibrillation threshold testing (DFT). Our     primary endpoint is: A change in OAAS scores of one point at the 30 minute data collection     time period.      Our secondary endpoints are: Lack of explicit recall of DFT testing and measurement of     perioperative level of comfort.      STUDY DESIGN AND SCOPE The population to be studied is those patients receiving a primary ICD     implant or an ICD battery change with defibrillation threshold testing (DFT).      All patients who have consented for ICD placement and DFT testing with moderate sedation will     be invited to participate in this research study. Patients who are not candidates for DFT     testing, as is determined by the EP physician, will be excluded from the study.      Demographic data including: age, gender, BMI, current medications and history of sleep apnea     will be collected. Data detailing the amount of drug administered during the procedure and     any use of reversal agents, will be retrieved from the medical record.      The study will be conducted within the Electrophysiology lab at Baystate Medical Center. An     enrollment of 60 subjects is expected to be completed within 6 months. 30 patients will     originate from the outpatient population and 30 from the inpatient.      Follow up assessments using the OAAS scale will be completed at 30 min, 1 hour and 4 hours     post procedure. Also, perioperative comfort and recall of DFT testing will be assessed at the     4 hour mark.   "
221301|NCT00749684|"     The aim of this observational study is to document the efficacy and tolerability of high-dose     interferon therapy in adult participants with malignant melanoma at high risk of relapse and     to compare them with the survival times and relapse rates in previous studies (historical     control).   "
221302|NCT00749697|"     The main purpose of the study is to establish a relationship between the administered     activity of the radioiodine and absorbed dose in the tumor sites.   "
221358|NCT00750438|"     This study explores the nutritional effects of fibre. Short chain fatty acid(SCFA), such as     propionate, are produced through the fermentation of fibre in the bowel. SCFA are thought to     have direct beneficial effects on the gut, appetite, weight and fat distribution. This study     will look into these effects by conducting a dose finding study and then a randomised     controlled study using healthy human volunteers.   "
221303|NCT00749710|"     Patients suffering from femoral neck or pertrochanteric fractures have a high rate of     mortality and morbidity associated mainly with deconditioning and immobilization. Surgical     management including open reduction and internaql fixation has been shown to reduce     complication and improve outcome in such patients. Delay of surgery produces less optimal     results and is associated with higher morbidity even after 24-48 hours of fracture event.      Patients treated with platelet antiaggregants are exposed to higher blood loss during surgery     and related complications, as demonstrated in patients treated with Aspirin. However,     cessation of antiaggregant therapy before surgery may be associated with complications of a     hypercoagulable state and surgery delay.      Clpopidogrel is a fairly new approved antiaggregant drug indicated in cases of failed aspirin     treatment in ischemic heart disease and cerebrovascular disease patients as well as in     primary prevention of stent restenosis.      No data regarding complications of hip surgery in patients treated with Clpopidogrel is     available.      Study hypothesis:      Definitive surgical treatment of patients treated with clopidogrel undergoing open reduction     and internal fixation of pertrochnteric and femoral neck fractures is safe although     associated with more extensive blood loss during surgery and postoperative wound     complications.   "
223875|NCT00782704|"     The aim is to develop and validate a morbidity index for postoperative complications in     patients undergoing visceral surgery.   "
221305|NCT00749736|"     Patients with chronic kidney disease (CKD) are commonly deficient in vitamin D, with low     levels of both calcidiol (25 hydroxy vitamin D) and calcitriol (1,25-hydroxy vitamin D).     Patients with CKD are also known to have abnormalities in their immune cells, increased     susceptibility to infection and increased prevalence of malignancies. In patients without     kidney disease, repletion of vitamin D appears to help some immune mediated diseases. Thus it     is logical that patients with CKD who are vitamin D deficient may benefit from repletion of     vitamin D, in either its native form (cholecalciferol/ergocalciferol) or in the form of     calcitriol or its analogues. However, no interventional data demonstrates that repletion     positively impacts immune status in CKD patients. To test this hypothesis, a large     interventional study will be required. However, prior to conducting this study, several     important steps are needed. The present proposal aims to generate the necessary data to     appropriately plan and conduct a future multi center interventional study. Specifically, we     will examine the following specific aims in a population of CKD stage 3 and 4 subjects from     Indiana University Affiliated Nephrology Clinics and determine        1. if abnormalities in immune cells and immune blood tests are related to abnormalities in          vitamin D.        2. how reproducible these changes are on repeat testing and        3. if repletion of vitamin D changes these cells and immune blood tests in a small pilot          study.   "
221306|NCT00749749|"     The purpose of this study is to determine whether the CollaRx Bupivacaine Implant is safe and     effective in reducing the amount of narcotic pain medication needed to control pain during     the first 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op     Pain Relief System.   "
221307|NCT00749762|"     This study seeks to determine in Neonatal Intensive Care Unit (NICU) patients specific     improvements in pulmonary function which may occur when an infant is ventilated in the prone     as compared to the supine position. Modest improvement in oxygen has been reported to occur     with prone positioning, but the exact etiology for this change is not clear. A special     incubator designed as an integrated care system allows routine care and the measurement of     both patient and ventilator breaths during mechanical ventilation. This study will utilize     this device to evaluate in NICU ventilated patients whether specific changes in pulmonary     function accompany position changes, and whether these are correlated to a change in     pulmonary gas exchange.   "
221308|NCT00749775|"     To collect the efficacy and safety information of Eplerenone on patients with hypertension     related to their appropriate use in daily practice.   "
221309|NCT00749788|"     The purpose of this study is to determine the effect of JTT-302 on the increase of High     Density Lipoprotein-Cholesterol (HDL-C) levels when administered daily for four weeks in     subjects with low HDL-C levels.   "
221310|NCT00749801|"     Nattokinase, first found by Dr. Hiroyuki Sumi in 1980, is a potent fibrinolytic enzyme     extracted from Natto, a popular soybean fermented food in Japan. It was confirmed that oral     administration of nattokinase (or natto) produced a mild and frequent enhancement of the     fibrinolytic activity in the plasma as indicated by the fibrinolytic parameters and the     production of tissue plasminogen activator. Other studies also showed a reduction in lipid     peroxidation and improvement of lipid metabolism. Short-term effect (less then 10 days) of     oral administration of nattokinase on both animal and human subjects has been studied and     reported. However, whether nattokinase possesses a beneficial effect to dyslipidemic patients     remains unclear. The aim of this study is to investigate the long-term effect (six month) of     the mono and multiple formulae of nattokinase, change of BP, lipid and fibrinolytic factors     from baseline and 6 months on dyslipidemic patients.   "
221326|NCT00750009|"     RATIONALE: Providing information that is tailored to answer patients' questions about     clinical trials may help patients with cancer decide to enroll in a clinical trial. It is not     known whether providing personalized information is more effective than basic information in     helping patients make decisions about clinical trials.      PURPOSE: This randomized phase III trial is studying personalized information to see how well     it works compared with basic information in helping patients make decisions about     participating in a clinical trial.   "
221327|NCT00750022|"     The purpose of this study is to evaluate the feasibility of using indirect calorimetry (IC)     within a comprehensive weight reduction program. Will individuals that receive a personalized     nutrition program, at baseline, from IC technology respond better to treatment compared to     individuals receiving IC technology at three months.   "
221468|NCT00743574|"     The investigators conducted a prospective un-blinded pilot study of Vitamin D plus Calcium     (Ca) supplementation in overweight (BMI > 27) premenopausal women diagnosed with Polycystic     Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and who were deficient     in vitamin D as reflected by serum 25-hydroxy (25-OH) vitamin D (serum levels < 20 ng/mL).   "
221311|NCT00749814|"     Background      Sleep disturbances are prevalent in hospitalized adult patients manifested as reduced sleep     time and sleep efficiency as well as increased awakenings. Insomnia is the most frequent     sleep disturbance. The effect of the change in sleep patterns in children prior to and after     an elective surgery has not been evaluated objectively. Sleep in hospital may influence     biological processes related to circadian rhythm.      Melatonin is a hormone secreted by the pineal gland in a diurnal rhythm regulated by light-     light suppresses melatonin secretion, while darkness enhances it. Melatonin has both     chrono-biotic and sleep promoting properties. Exogenous administration of melatonin shortens     sleep latency, increases sleep efficiency and total sleep time. Melatonin also improves     disrupted circadian rhythm. Melatonin promotes sleep in a similar way to the natural sleep     process, and maintains normal sleep architecture.      Melatonin has a positive effect on children with sleep disturbances and is routinely     administrated in pediatric sleep centers around the world for insomnia and a variety of sleep     disorders. Side effects of melatonin are rare and scarce. Circadin is a slow released     formulation of melatonin, which mimics night time secretion of natural melatonin. Children     with sleep disorders who were treated with controlled release melatonin, demonstrated     improvement in sleep latency and total sleep time.      It is reasonable to assume that hospitalized children have disturbed sleep patterns prior to     and following elective surgery. We hypothesize that melatonin will improve sleep patterns     prior to and following surgery, by reducing sleep latency and extending total sleep time. We     also hypothesize that this improvement will have positive impact on anesthetic stress     measures and on recovery.      The purposes of the study are: 1. To characterize sleep patterns in children undergoing     surgery on the admission night prior to surgery; 2. To evaluate the effect of melatonin on     sleep parameters on the night prior to surgery in children; 3. To evaluate the effect of     melatonin on physiologic stress parameters during anesthesia and surgery in children; 4. To     evaluate the effect of melatonin on sleep parameters of children postoperatively; 5. To     evaluate the effect of melatonin on postoperative outcome measures in children.      Patients, Methods. Ninety children (aged 4-18 years) will be evaluated. Sleep disorders will     be screened by a pediatric sleep questionnaire. Sleep will be assessed by sleep logs and     actigraphy for sleep onset time, sleep latency, total sleep time, total wake time, number and     length of awakenings, sleep efficiency, sleep fragmentation index and sleep mean activity     score. Recovery measures will include: length of hospitalization, infection rate, body     temperature, cortisol levels, cooperation with medical staff.      Study plan. The research will comprise of 5 consecutive steps. Step 1 will include the week     prior to surgery and include sleep evaluation to all participants by sleep log and     actigraphy. Step 2 is the night prior to surgery and will include sleep log and actigraphy.     30 children will receive melatonin (Circadin) 2mg, 30 children will receive placebo and 30     children will constitute the control group. Step 3 will be conducted during anesthesia and     surgery where stress variables and need for anesthesia will be recorded. Step 4 will take     place during post-operative hospitalization and will include actigraphy and sleep logs. Step     5 will take place at home two weeks after discharge and will include actigraphy and sleep     logs.   "
221312|NCT00749827|"     Contrast induced nephropathy (CIN) is a term applied to acute renal failure associated with     intravascular injection of iodinated contrast agents typically used for cardiac angiography.     CIN occurs in about 15% of those who have had cardiac angiography, with dialysis required by     about 0.5% of cases. The development of CIN is associated with other adverse outcomes     including major adverse cardiovascular events (MACE) and death. The mechanism underlying the     association with MACE and death is unclear and it is largely unknown whether measures     reducing the frequency or severity of CIN also reduce these associated adverse events.      The cause of CIN in humans is not known, but many preventive therapies have been tested based     on our understanding of the mechanism underlying CIN from animal models. Despite multiple     studies, no one drug or therapy has been proven to consistently prevent CIN at this time.     Prophylactic fluid therapy is uniformly recommended as a component of preventive approaches     for CIN. However, the optimal type, dose and duration of fluid therapy remain unclear.     Existing studies suggest a role for isotonic saline[3] or bicarbonate[4]. Initial use of     hypotonic fluid followed by isotonic fluid might allow a more rapid and sustained increase in     tubular fluid flow by suppression of ADH. This should assist in reducing tubular fluid     viscosity and the potential for injury by contrast medium.      The aim of this research program is to design and test strategies for the prevention of CIN     in patients undergoing elective cardiac angiography or percutaneous coronary intervention     (PCI). The primary purpose of this pilot study will be to determine the biological     plausibility of using a hypotonic solution for CIN prophylaxis.      Specific Objectives:      Primary        1. To compare the effects of two fluid prophylaxis strategies for CIN on urine output,          urine pH, urine composition (urine metabolic profiling), a novel marker of renal injury          (NGAL) and urine osmolality Secondary        2. To assess the relative sensitivity of definitions of CIN based on changes in serum          creatinine or cystatin C within 72 hours post contrast.        3. To determine the feasibility of a future multicenter randomized trial of a hypotonic          fluid prophylaxis strategy for the prevention of radiocontrast nephropathy.   "
221313|NCT00749840|"     Through a prospective observational cohort study enrolling patients newly diagnosed with     Human immunodeficiency virus (HIV):      Aim 1: Assess attitudes and beliefs about HIV disease and care over time and relate those     attitudes and beliefs to success in following the Steps of HIV Care.      Aim 2: Validate a simple visual analogue scale for assessing adherence to highly active     antiretroviral therapy (HAART) in patients newly starting HAART in routine care.      Aim 3: Implement latent growth curve analysis for modeling changes in attitudes and beliefs     over time, and for assessing the impact of the components of the Steps of HIV Care model on     health outcomes.   "
221314|NCT00749853|"     Available data from in vitro studies and clinical trials indicate that genetic factors play a     significant role in the success of controlled ovarian stimulation (COS) prior to in vitro     fertilization - embryo trandfer (IVF-ET). Women with the FSHR Ser680Asn Ser/Ser genotype make     up between 13% and 26% of women undergoing IVF-ET and are characterised by higher basal FSH     serum concentrations, the need for a higher amount of FSH for COS, and a higher risk of poor     response to COS and cycle cancellation.      The investigators therefore intend to perform a study to investigate whether a     dose-intensified COS protocol based on FSHR genotype status in women with the FSHR Ser680Asn     Ser/Ser genotype is more effective than routine management in terms of        -  the mean number of follicles        -  the mean number of embryos        -  the rate of poor responders        -  the rate of women with cycle cancellations, and v) the clinical pregnancy rates.      Eligible women will be randomized to a stimulation protocol characterised by a longer     duration and increased dosage of FSH stimulation (group A) or a standard stimulation protocol     (group B).   "
221315|NCT00749866|"     The hypothesis of this randomized placebo controlled trial is that targeted nebulized     gentamicin to the airways will reduce bacterial burden and limit neutrophil airways     inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise     capacity and health related quality of life with a reduction in exacerbation frequency and     health care utilization.   "
221316|NCT00749879|"     This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50     mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers     in the fed and fasting states.   "
221317|NCT00749892|"     The goal of this clinical research study is to learn if Tarceva™ (erlotinib hydrochloride;     OSI-774) can help to shrink the tumor or slow its growth, before surgery, in patients with     transitional cell carcinoma.   "
221318|NCT00749905|"     A prospective randomized controlled investigator-blinded study to compare efficacy of low     fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and     standard bowel preparation for colon capsule examination   "
221319|NCT00749918|"     This study was intended to evaluate the effect of vitamin D supplementation on insulin     sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D     supplementation to normal levels in patients with impaired fasting glucose will result in     improved insulin sensitivity and improved beta cell function.   "
221320|NCT00749931|"     The purpose of this study is to show that addition of device use to a routine breast cancer     tumor excision procedure is beneficial and assists the surgeon in correctly determining the     extent of excision.   "
221321|NCT00749944|"     Study objective is to compare neuropsychiatric adverse events in subjects treated with     varenicline or placebo in a controlled setting where both groups are experiencing nicotine     withdrawal.   "
221328|NCT00750035|"     Background      It is uncertain whether subtotal abdominal hysterectomy results in better bladder, bowel, or     sexual function than total abdominal hysterectomy.      Methods      The investigators conducted a randomized, double-blind trial comparing total and subtotal     abdominal hysterectomy in 279 women referred for hysterectomy because of benign disease; most     of the women were premenopausal. The main outcomes were measures of bladder, bowel, and     sexual function at 12 months. The investigators also evaluated postoperative complications.   "
221329|NCT00750048|"     The aim of this study is to check if Naloxone induce an inhibiting effect on the analgesic     effect of paracetamol in healthy volunteer, using evoked potentials.   "
221330|NCT00750061|"     This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be     randomized into two groups. The subjects in the Treatment Group will be administered with     lithium carbonate, while the Control Group will receive placebo.      Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment     group, the dose will be adjusted according to the serum lithium level while in the control     group there will be a sham adjustment.      The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The     outcomes will be compared with baseline pre-treatment data to obtain neurological change     scores. The efficacy and safety will be analyzed comparing the results of the treatment     group with those of the control group.   "
222426|NCT00756678|"     Efficacy and acceptability of two new artificial tears following two weeks of treatment in     patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then     crossover to the alternate treatment for 7 days.   "
221331|NCT00750074|"     There are two fundamentally different ways to ventilate critically ill patients: constant     flow, volume-preset modes (such as volume assist-control) and pressure-preset modes (such as     pressure-control and pressure-support). Critically ill patients suffer mechanical     derangements of the respiratory system that raise the work of breathing. Knowledge of these     mechanical properties is useful diagnostically and as a measure of response to treatment over     time. It has been proposed that only constant flow, volume-preset modes are able to offer     diagnostic information about the changes in the subject's lungs in terms of resistance and     elastance properties. This study proposes to examine if similar information can be extracted     from pressure-preset modes by comparing information from both modes of ventilation.   "
221332|NCT00750087|"     the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months     in patients treated with Seroquel XR.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
221333|NCT00750100|"     In this study,the investigators compared two protocols for controlled ovarian     hyperstimulation in infertility patients requiring IVF. In the control group, the patient     undergoes a standard antagonist protocol. In the study group, the administration of     gonadotropins is stopped in the late follicular phase and replaced by low dose human     chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved     in both groups.   "
221334|NCT00750113|"     Patients having uncontrolled or poorly controlled hypertension are at risk of experiencing     cardiovascular events such as myocardial infarction or stroke. To reduce this risk an     appropriate antihypertensive therapy should allow to reach a target blood pressure of less     than 130/80 mmHg in order to maximise cardiovascular protection.The purpose of this study is     to evaluate the efficacy in blood pressure control when anti-hypertensive therapy is     initiated with a combination of low dose Nifedipine GITS and Telmisartan compared to a     regimen starting with monotherapy before adding the other drug.The primary efficacy parameter     will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring     (ABPM) at 16 weeks of treatment compared to baseline   "
221335|NCT00750126|"     To assess the engraftment of hematopoietic stem cells following reduced-intensity     conditioning in children presenting with solid tumors or hematological malignancy by     evaluating post-transplantation chimerism and hematological reconstitution.      To study acute and/or chronic graft-versus-host reaction (incidence and severity) and immune     reconstitution, post-transplantation To study the effectiveness of the protocol on tumor     response.      To study overall survival.   "
221336|NCT00750139|"     A research study to compare the safety and effectiveness of an investigational medication     called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot).   "
221337|NCT00750152|"     A research study to compare the safety and effectiveness of an investigational medication     called NAFT-500 to placebo (no active treatment), when used in subjects with tinea cruris,     also known as jock itch.   "
221338|NCT00750165|"     Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive     sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single     positive pressure that has been individualized for the patient to prevent obstructive     respiratory events. However, the therapeutic pressure may vary by sleep stage and body     position within a single night and may change over the course of several nights. One approach     to dealing with this variability is the use of automatically adjusting CPAP that responds to     patient breathing patterns with alterations in the delivered pressure. This study is designed     to determine the effectiveness of using the energy spectrum analysis of flow signals to     automatically adjust CPAP pressure and improve sleep variables. Thirty subjects who require     CPAP will be recruited from the NYU sleep disorders center. Following diagnostic studies     (either split night or full night) the subject will undergo a night of treatment with the     Fisher and Paykel Healthcare AutoPAP. Efficacy of treatment will be evaluated based on     normalization of sleep disordered breathing while treated with the AutoPAP.   "
221339|NCT00750178|"     This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of     MK0683 in patients with advanced cancer.   "
221355|NCT00750399|"     This is a Phase I clinical trial to test the safety and tolerability of intravitreal     ranibizumab in the treatment of radiation retinopathy following plaque brachytherapy for     patients with choroidal melanoma using the incidence and severity of events criteria.      The secondary objective is to assess the efficacy of intravitreal ranibizumab on regression     of radiation retinopathy by ophthalmic examination, fundus photography, fluorescein     angiography, and optical coherence tomography, as well as visual acuity.   "
221356|NCT00750412|"     The purpose of this study is to compare the TeenScreen intervention to usual care for     adolescents who screen positive for mental health problems in a pediatric emergency     department. It is anticipated that adolescents receiving the TeenScreen intervention will be     more likely to attend a first session of outpatient mental health services within 60 days of     the initial screening than those receiving the usual care.   "
221340|NCT00750191|"     Each patient was assigned to one of the two groups: IDB or Sham. On the day of the procedure,     an IV was inserted in pre-procedural area and patient transported to the procedure room. The     procedure will be completed under fluoroscopy in prone position. Patients were given 1-4 mg     of midazolam for relaxation before the procedure and, if needed, 50-100 mcg of fentanyl IV     during the procedure. The patients was randomly assigned to treatment or placebo using     computer-generated codes maintained in sequentially numbered opaque envelopes. The physician     performing procedure was informed of the assignment. In IDB group, guided by the fluoroscopic     imaging, two transdiscal probes was positioned in the posterior annulus using a     posterolateral, oblique approach. First, two electrically insulated 17G transdiscal     introducers was used to gain an access to the disc space. Than, two radiofrequency probes     will be positioned through each of the introducers bilaterally to create a bipolar     configuration. Placement of the transdiscal probes within the disc annulus will be confirmed     using oblique, lateral, and anterior-posterior fluoroscopic images. Sham group had their     introducers and electrodes positioned just outside of the disc. This was also be documented     using fluoroscopy. Investigator attached the electrodes to inactive heater control device     that provide a similar auditory and visual experience for the patient. Patients were     therefore remain blinded to actual treatment and physician performing procedure was not     involved in patient's follow-up. Patients were awake and communicating with the physician     conducting the procedure and if pain in legs were present and increased during the procedure,     the heating protocol would be stopped. Following completion of procedure the patient was     transferred to recovery and monitored for 45 minutes, then discharged home with instructions.     The patients were followed over a period of 12 months.   "
221375|NCT00750698|"     Preclinical studies have shown that SNDX-275 is able to reactivate the expression of EGFR,     E-cadherin and ErbB3 expression. The combination of SNDX-275 with erlotinib (an EGFRi) in     patients who are progressing on erlotinib will show measurable activity as evidenced by the     disease control rate and with an acceptable safety profile.   "
221341|NCT00750204|"     The purpose of this study is to compare airway pressure release ventilation (APRV) to     conventional mechanical ventilation (MV) in patients with acute lung injury (ALI) to     determine if APRV can reduce agitation, delirium, and requirements for sedative medications.     We will also compare markers of inflammation in the blood and lung to determine if APRV     reduces ventilator-induced lung injury (VILI), compared to conventional mechanical     ventilation.      The proposed study is a randomized, crossover trial. We plan to enroll 40 patients with ALI     and randomize to APRV or conventional MV for 24 hours. After this time the patients will be     switched to the alternative mode of ventilation (MV or APRV) for another 24 hours. To assess     breathing comfort, at the end of each 24-hour period we will measure the amounts of sedative     and analgesic medications used. We will also measure the concentrations of markers of     inflammation in the blood and lung as measures of VILI. Finally, throughout the study we will     compare the adequacy of gas exchange with APRV compared to conventional MV.   "
221342|NCT00750217|"     Buprenorphine is an important alternative to methadone in the maintenance treatment of heroin     addiction. Transfer from methadone to buprenorphine requires a reduction of daily methadone     dosage below 30 mg to avoid withdrawal after the first buprenorphine intake. The study     hypothesis states that the transfer from a daily methadone dosage between 60 mg and 100 mg to     buprenorphine can be carried out without withdrawal using buprenorphine patches (35 micro     grams per hour) within 12 to 48 hours after last methadone intake.   "
221343|NCT00750230|"     The purpose of this study was to evaluate the use of the dietary supplement Natural Eggshell     Membrane (NEM) for the treatment of joint and connective tissue discomfort, pain, and     flexibility.   "
221344|NCT00750243|"     The purpose of this study is to compare naproxen plasma levels and gastroduodenal mucosal     injury after administration of LT-NS001 as compared to Naprosyn in subjects age 45-70.   "
221345|NCT00750256|"     A first-time in human study to investigate the safety, tolerability, pharmacokinetics and     pharmacodynamics of GSK1278863A in healthy subjects   "
221346|NCT00750269|"     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the     tumor and cause less damage to normal tissue.      PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic     body radiation therapy and to see how well it works in treating patients with stage I     non-small cell lung cancer.   "
221347|NCT00750282|"     The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK     6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque     (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein     accumulating in brain tissue already from early stages of Alzheimer's disease (AD). IMP is     therefore a potential tracer to be used for detecting amyloid plaques. For each subject it is     required to visit the study centre during the screening phase, on the PET imaging day and for     1 follow-up visit on the next day. A telephone call for safety follow-up will be performed 7     days after IMP administration. During the screening phase the subject's medical, neurological     and surgical history, specific laboratory tests related to AD, MRI of the brain and certain     neuro-psychiatric tests will be performed. Clinical safety measures (physical examinations,     vital signs, electrocardiogram (ECG) and laboratory tests) will be performed on the PET     imaging day before IMP injection and monitored during and after two PET imaging sessions.     Clinical safety measures will be performed again on the follow-up visit next day. The results     of PET imaging with IMP will be compared between probable AD patients and healthy volunteers     (HV). The clinical diagnosis is based on international validated and accepted criteria and     established after comprehensive clinical and neuro-psychiatric examinations   "
221348|NCT00750295|"     The primary objective of this study is to assess the safety, tolerability and activity of     escalating multiple doses of SBR759 in patients with chronic kidney disease on hemodialysis.   "
221349|NCT00750308|"     This study will measure the effect of the agent tadalafil on glucose and insulin homeostasis     in people with metabolic syndrome in the presence and absence of an ACE inhibitor.   "
221350|NCT00750334|"     This study will be used to determine the maximum tolerated dose of oral clofarabine when     administered daily for 14 consecutive days repeated every 21 days.   "
221351|NCT00750347|"     Evaluation of an possible inhibiting effect of Rimonabant on the analgesic effect of     Paracetamol in healthy volunteers   "
221352|NCT00750360|"     The present study collects data on safety and reactogenicity of the vaccine in the local     target population (600 or more subjects) as per the requirement of Korean Food and Drugs     Administration (KFDA).   "
221353|NCT00750373|"     There have been no prospective clinical studies in infective endocarditis comparing early     surgery with the conventional treatment strategy based on current guidelines. The purpose of     this prospective randomized trial is to compare clinical outcomes of early surgery versus     conventional treatment strategy in patients with high embolic risk of infective endocarditis.   "
221354|NCT00750386|"     This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of     paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage     Ic-IV ovarian cancer.   "
221357|NCT00750425|"     Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the     body handles the experimental drug cediranib, in patients with advanced cancer.   "
221359|NCT00750451|"     Recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts     with in vitro fertilization treatment. The reason is usually obscure. Many empirical     treatments have been offered without substantial evaluation. Heparin is thought to play a     role in the embryo implantation process beyond its anticoagulation effects. The proposed     study aims to assess the effectiveness and safety of empirical administration of low     molecular weight heparin in patients undergoing a new IVF treatment cycle after multiple     failed attempts.   "
221360|NCT00750464|"     Collection of thermal images of women with breast tumors in varying degrees of severity in     order to evaluate and improve Real Imaging's device (RI3.0) capabilities , which will     assist in early detection of breast cancer.   "
221361|NCT00750477|"     The purpose of this study is to evaluate the effectiveness of Natural Eggshell Membrane (NEM)     for the relief of pain and stiffness associated with moderate osteoarthritis of the knee and     to compare the effectiveness of NEM to placebo.   "
221363|NCT00750516|"     This study seeks to determine whether the Lactic Acid blood level in a critically ill patient     must be drawn with a non-tourniquet venipuncture. The null hypothesis is that there is no     significant difference in Lactic Acid blood level in critically ill patients in a sample     taken from either with a tourniquet or a non-tourniquet veni-puncture.      Monitoring of Lactic acid level is helpful in both identifying potentially serious ill     patients as well as identifying in the ICU patients with high morbidity and mortality.      When a patient arrives to an Emergency Department and that patient is hypotensive (BP less     than or equal to 90 systolic), the nursing staff often starts an IV and if possible draws the     patient's initial blood tests off that first IV site; or if the patient has had an IV started     in the field by EMS, the nursing staff will draw blood from another site using a tourniquet.     This initial work up by the nursing staff takes 15 -20 minutes before a physician may see the     patient. Since the present standard Lactic Acid test must be drawn either by arterial     puncture or venipuncture without a tourniquet, this test is rarely done as part of their (the     RNs) initial blood draws.      This simple impediment of needing to repeat the venipuncture without a tourniquet, especially     in patients who often have venous access difficulty, delays the identification of appropriate     patients for early and aggressive management- particularly those with sepsis.      Our hypothesis is that this requirement for a non-tourniquet blood draw is unnecessary.   "
221364|NCT00750529|"     The aim of the study is the analysis of two inhibitors of Ach-E: galantamine and donépézil in     over 65 years' old patients suffering from Alzheimer disease (MMSE between 20 and 26) without     Alzheimer's medication.   "
221365|NCT00750555|"     Phase II Study of Maintenance Tarceva (Erlotinib) in patients with locally advanced Head and     Neck Cancer after treatment with curative intent   "
221366|NCT00750568|"     Terbutaline is a medication that is used to treat serious asthma attacks (status     asthmaticus). The purpose of this study is to determine if terbutaline is effective and safe     when given as a continuous intravenous infusion to children ages 2 years to 18 years of age.     Children participating in this study are inpatients in the Intensive Care Unit with a     diagnosis of status asthmaticus and are receiving terbutaline as part of their routine care.     Blood samples and physiological assessments will be used to determine how the body is using     terbutaline and how well it is working.   "
221367|NCT00750581|"     A large patent ductus arteriosus (PDA) is associated with congestive heart failure, pulmonary     hemorrhage, chronic lung disease (CLD), necrotizing enterocolitis (NEC) and intraventricular     bleeding. Indomethacin is the first line of treatment for PDA. Failure of ductal closure with     the first course of indomethacin is reported in 30-40% of infants, with a higher failure rate     in infants weighing < 1000 gm. PDA ligation is associated with early postoperative     hypotension, oxygenation failure and adverse neurodevelopmental outcome in preterm infants.     The use of escalating doses of Indomethacin in the treatment of persistent PDA was found to     be safe and decreased the need for PDA ligation without adverse effects in one observational     study.We hypothesize that the use of an escalated dose of intravenous indomethacin will     result in an increase in the probability of survival without need for surgical ligation of     PDA as compared to a standard dose indomethacin in newborn infants < 29 weeks of gestational     age with persistent PDA.   "
221368|NCT00750594|"     This study will be the first to provide data about the relationship between PFO and migraine     in children. By establishing the actual prevalence, we will better understand if PFO plays a     role in the occurence of pediatric migraine and, thus, provide the incentive to perform     additional studies evaluating whether PFO closure is an effective treatment option for     pediatric migraine. For children with migraine headaches, discovering novel and effective     treatments would be life altering.   "
221369|NCT00750620|"     The objective of this study is to assess and compare the pharmacokinetic properties of YM178     in normal subjects and those with mild, moderate and severe renal impairment.   "
221370|NCT00750633|"     The purpose of this study is to determine if an otic formulation is safe and effective for     the treatment of acute otitis externa (AOE).   "
221371|NCT00750646|"     This study is interested in monitoring how patients take eye drops, both through     video-recordings and adherence monitoring, as well as their perceptions about their eye     medications; including the dosing schedules, instillation techniques and effect on their     disease.   "
221372|NCT00750659|"     Current therapeutic results in advanced chronic myeloid leukemia (CML) and Ph+ acute     lymphoblastic leukemia (ALL) are rather disappointing. Most of these patients will eventually     undergo allogeneic stem cell transplantation. Nilotinib is a novel TKI tyrosine kinase     inhibitor with 30 fold more potency than Imatinib. Based on previous preliminary experience     the author we rationalize that Nilotinib therapy pre- allogeneic transplantation for patients     with advanced CML and Ph+ALL will reduce tumor mass pre- transplant achieving a state of     minimal residual disease (MRD) and therefore may improve transplantation outcome without     increasing toxicity. In addition it will allow time for improving patient medical condition     and for finding an unrelated donor which will enable allogeneic transplantation , and to     induce anti tumor effect post PBSC w\o DLI ( donor lymphocyte infusion)   "
221373|NCT00750672|"     The purposes of this study are to examine the needs (symptoms, support, information) and     satisfaction of women during follow-up in the community after completing treatment for     endometrial cancer. This information will be collected from the perspective of the women     themselves, their primary care providers (family physician or gynecologist) and the health     care providers (oncologist, nurses, social worker, psychologist) at the cancer centre.   "
221374|NCT00750685|"     The purpose of this study is to determine the safety and effectiveness of the Becker     Expander/Breast Implant in women who are undergoing primary breast reconstruction. Safety     information on the rate of complications, such as infection will be collected, and used to     help determine device safety. These implants are investigational devices.      Approximately 300 patients at centers across the United States will be enrolled in this     research study, by up to 30 sites. These patients will be implanted with Becker     Expander/Breast Implant and monitored for 10 years to collect information on risks associated     with the implant surgery as well as changes in the way these patients feel about themselves.   "
221376|NCT00750711|"     The purpose of this study is to compare the efficacy of 4 mm irrigated catheters with 2 mm     irrigated catheters for ablation of typical flutter.It's a prospective randomised multicenter     study.   "
221377|NCT00750724|"     OA knee is a common degenerative diseases of the joint.        -  There are many methods to treat this condition.        -  Hyaluronic acid is one of the recomended treatment of OA knee.        -  There is no any study on MRI change after injection hyaluronic acid.        -  The Hypothesis is 25 mg of sodium hyaluronate (2.5 ml) would preserve the joint space in          patient with osteoarthritis of the knee compared to placebo .   "
221378|NCT00750737|"     The objective of this study is to compare the safety and efficacy of ABLC versus oral     Posaconazole in the prevention of invasive fungal infections in high risk patients with     hematologic malignancies or hematopoietic stem cell transplant.      Primary objective is to demonstrate the low toxicity rate and low rate of invasive fungal     infections associated with ABLC or Posaconazole prophylaxis.      Secondary objective will be to compare the cost effectiveness of these two prophylactic     regimens.   "
221379|NCT00750750|"     This study was conducted to compare the effectiveness and safety of mometasone nasal spray     once daily or twice daily with amoxicillin or with placebo in treating the signs and symptoms     of acute rhinosinusitis. Patients received mometasone nasal spray 2 sprays per nostril once     daily, 2 sprays per nostril twice daily, amoxicillin 500 mg three times a day, or placebo     three times a day. Patients on nasal spray were treated for 15 days and patients on     amoxicillin or placebo were treated for 10 days. All patients were followed-up with a 14-day     no-treatment observation period.   "
221380|NCT00750763|"     Colonoscopy is the gold standard investigation for assessing the lining of the colon. Colon     cleansing preparations are required to be taken prior to colonoscopy to provide effective     visualisation and identification of any abnormalities and different types of colon cleansing     preparations exist.      Some colon cleansing preparations have been shown to cause visible changes in the lining of     the bowel which may cause confusion and incorrect diagnoses to be made.      This audit aims to assess the ability of different colon cleansing preparations to clear the     colon of faeces. The tolerability of each will also be assessed, as will any changes in the     lining of the bowel to assess if one type of colon preparation is more likely to cause     visible changes than another.   "
221381|NCT00750776|"     Rating and registration in KMS database of all patients in anti-psychotic treatment with 8     selected items from PANSS, GAF, 21 selected items from UKU, 3 selected items from TSQM. and     measurement of compliance. Frequency of use of rating scales per participating health care     professional.   "
221382|NCT00750789|"     It has been proven in in-vitro studies that dates decrease the oxidative stress in serum.     There have been no in-vivo studies to this date. The current study aims to test whether dates     consumption by healthy adults decreases serum oxidative stress and improves serum PON1     activity and serum lipid profile.   "
221383|NCT00750802|"     The purpose of the study is to determine the effects of AZD6280 compared to lorazepam on     sleepiness, concentration and brain activity.   "
221384|NCT00750815|"     Cyclophosphamide is a chemotherapy agent with known activity in myeloma. The new regimen that     we will test in this study is called CVDD and contains Cyclophosphamide with Bortezomib     (VELCADE), Pegylated Liposomal Doxorubicin (DOXIL®, PLD), and Dexamethasone (VDD).      The purpose of this study is to determine if the addition of another type of chemotherapy     agent, Cyclophosphamide, to the regimen VDD (CVDD) is well tolerated and improves response     rates in myeloma. We will also find the highest safe dose of the study drugs taken together     that a patient can tolerate, and how long it takes for multiple myeloma patients to respond     after they have taken the study drugs and how long the response lasts.   "
221385|NCT00750828|"     The investigators questioned whether patients with dry mouth complaints display any reduction     in residual saliva coating the gingiva and other selected mucosal surfaces. We further     intended to test the hypothesis that Gingival Crevicular Fluid volume in patients with dry     mouth could be different from that of control subjects. Correlations between gingival/mucosal     wetness; and unstimulated whole salivary flow rate or minor salivary gland secretion rates     and the correlations between clinical periodontal status and salivary measures were also     attempted.   "
221386|NCT00750841|"     Phase I, open study to assess the effect of rifampicin, a marketed drug, on how the body     handles the experimental drug cediranib in patients with advanced cancer.   "
221387|NCT00750854|"     The purpose of this study was to evaluate the use of the dietary supplement Natural Eggshell     Membrane (NEM) for the treatment of joint and connective tissue discomfort & pain.   "
221469|NCT00743587|"     The purpose of this study is to determine if the measurement of pressure pain thresholds, in     patients suffering osteoarthritis of the thumb, can be used to assess the activity of     potential analgesic agents after a single dose. The study will use agents known to give pain     relief in osteoarthritis as positive controls. These agents are: tramadol, naproxen and     oxycodone.   "
221388|NCT00750867|"     Multiple System Atrophy (MSA) is a progressive sporadic neurodegenerative disorder leading to     widespread loss of brain cells that results in parkinsonian, cerebellar and autonomic     dysfunction. The cause of the MSA remains unclear. Available treatment is symptomatic only     and does not alter the course of disease.      Although the cause of MSA remains unclear, there is evidence of presence of common     neuroinflammatory mechanisms in the MSA brains including activation of microglia and     production of toxic cytokines. This research protocol is based on hypothesis that the MSA     progression can be altered by blocking the neuroinflammatory activity.      This protocol includes administration of intravenous immunoglobulin (IVIg). IVIg contains     antibodies derived from human plasma which can block the inflammatory responses in the brain     that can lead to loss of brain cells.   "
221389|NCT00750880|"     This open-label, single arm study will investigate the safety, tolerability and efficacy of     tocilizumab monotherapy, or combination therapy with non-biologic disease modifying     antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive     tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The     anticipated time on study treatment is 3-12 months, and the target sample size is >500     individuals.   "
221390|NCT00750893|"     This protocol posting deals with objectives and outcome measures of the primary phase at one     month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use     of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves     male or female infants from the age of 6 weeks at the time of the first vaccination. The     vaccination course must be completed by the age of 24 weeks.   "
221391|NCT00750906|"     This study will be conducted to determine the pharmacodynamics, cardiovascular and     biochemical effects of succinylcholine when given during electroconvulsive therapy. (ECT).     This is a single center, prospective, study in patients who will be receiving ECT as     indicated and prescribed by their psychiatrist. The study will be performed twice on each     patient, 48-72 hours apart during consecutively scheduled ECT procedures.   "
221392|NCT00750919|"     This trial is a 26-week, open label extension trial to investigate safety and explore     efficacy of esmertazapine in participants with insomnia who completed protocol     21106/P05701/MK-8265-002 (NCT00631657).   "
221393|NCT00750932|"     The purpose of the proposed project is to characterize the neutrophile proteases which     participate in the chronic inflammatory phenomenon associated with the cystic fibrosis and     which are responsible for the degradation of the lung tissue.      The respiratory failure which results from it is one of main causes of the fatal evolution of     this pathology but the anti-inflammatory therapies based on the use of antiproteases     targeting specifically the soluble elastase did not end, until now, in the hoped results.      The identification of the other noxious targets is a crucial element to give new orientations     to the anti-inflammatory strategies based on the administration of antiproteases which remain     a promising way.   "
221394|NCT00750945|"     Sensory and motor cueing have been demonstrated as useful ambulation training techniques for     Parkinson's disease (PD). This study is aimed to evaluate the effectiveness of treadmill     training program with music cueing for mild to moderate PD patients.   "
221395|NCT00750958|"     The purpose of this study is to determine the incidence of clinically significant rhythm and     rate changes in ED patients who are not placed on conventional telemetry, and to test the     user-friendliness of a automated clinician alter device in hectic and noisy setting of a busy     emergency room.   "
221396|NCT00750971|"     While glucocorticoids and immunosuppressants ameliorate manifestations of SLE in many     patients, current therapies are insufficient to control the disease in a subset of patients,     and their clinical prognosis remains poor due to the development of vital organ failure,     cumulative drug toxicity and to the increased risk of cardiovascular disease and malignancy.     Immunoablative chemotherapy followed by autologous hematopoietic stem cell transplantation     (ASCT) has recently emerged as a promising experimental therapy for severely affected     patients, providing them the potential to achieve treatment-free, long-term remission. The     investigators postulate that immunoablative therapy eliminates or effectively reduces the     level of autoreactive T and B lymphocytes and then regeneration of de novo immunity resets     the autoreactive immune system into a self-tolerant, protective immune system resulting in     prolonged and treatment-free remission.   "
221397|NCT00750984|"     This study compares the posterior approach to the anterolateral approach using the ReCap®     Total Hip Resurfacing System.   "
221398|NCT00750997|"     This project seeks to determine the effect of prehospital resuscitation with hypertonic     saline vs. conventional crystalloids on the inflammatory response after injury. The leading     cause of late mortality following injury is multiple organ dysfunction syndrome (MODS), which     results from a dysfunctional inflammatory response after injury. Previous studies suggest     that hypertonic saline may be beneficial by modulating this initial response and decreasing     subsequent organ injury. This project takes advantage of a unique opportunity, afforded by an     NIH-funded multi-center clinical trial of hypertonic resuscitation (conducted by the     Resuscitation Outcomes Consortium), to obtain blood samples from patients enrolled in this     trial to analyze inflammatory responses early after hypertonic vs. conventional     resuscitation. This study was an ancillary study to the main randomized clinical trial and     thus prospective observational in nature      The proposed study will be carried out in experiments grouped in three Specific Aims: Aim 1     provides a thorough investigation of the immunomodulatory response following hypertonic     resuscitation with regard to neutrophil, monocyte, and T cell responses at serial time points     after injury and resuscitation. Aim 2 comprises experiments to investigate the mechanisms by     which hypertonicity may alter inflammatory cell signaling. Aim 3 seeks to correlate the     laboratory findings with clinical endpoints reflective of immune dysfunction including     inflammation, organ failure, nosocomial infection, and sepsis.      The investigators hypothesize that hypertonic resuscitation will be associated with     modulation of the excessive inflammatory response seen after injury and thus will result in     reduced rates of inflammatory organ injury.   "
221470|NCT00743600|"     This study will use healthy volunteers and patients with shoulder problems (pain or impaired     movement). Ultrasound will be used to image and document the appearance of both normal and     abnormal shoulder structures.   "
222817|NCT00761514|"     The primary objective of this study is to evaluate quality of life changes in Puerto Rican     subjects with Rheumatoid Arthritis treated with Humira (adalimumab) as their first Anti-TNF     Monoclonal Antibody.   "
221399|NCT00751010|"     The etiology of pain in women with IC is often difficult to identify resulting in unnecessary     medical and surgical treatments (e.g. hysterectomies). The vulva may actually be the site of     some of the reported pain in women with IC, not the urethra or bladder. IC and vulvodynia can     impact one's sexual functioning and diminish one's quality of life. Unfortunately, vulvodynia     is often unrecognized since it is not part of the usual urological assessment with IC     patients.      Vulvodynia is characterized by persistent generalized or localized vulvar pain of varying     degrees often characterized as burning, suggestive of a neuropathic pain response.   "
221400|NCT00751023|"     Methamphetamine dependence is a serious public health problem with no pharmacologic     treatments currently available. Relapse rates are high in this population. Exposure to cues     previously associated with methamphetamine use may induce profound craving in abstinent     individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits     that may undermine successful participation in psychosocial treatments. Medications which     improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence     rates, especially in the critical early period of recovery. Modafinil is an atypical     stimulant medication with evidence to support its use in treating cocaine dependence and     attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate     modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.   "
221401|NCT00751036|"     The study will investigate the comparative efficacy and safety of two oral inhibitors of Kit     and PDGFR: nilotinib 400 mg bid, a novel agent, and imatinib 400 mg bid, an approved agent     with an established efficacy.   "
221404|NCT00751075|"     This study was conducted to compare the effectiveness and safety of mometasone nasal spray     once daily or twice daily with amoxicillin or with placebo in treating the signs and symptoms     of acute rhinosinusitis. Patients received mometasone nasal spray 2 sprays per nostril once     daily, 2 sprays per nostril twice daily, amoxicillin 500 mg three times a day, or placebo     three times a day. Patients on nasal spray were treated for 15 days and patients on     amoxicillin or placebo were treated for 10 days. All patients were followed-up with a 14-day     no-treatment observation period.   "
221405|NCT00751088|"     The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To     date, there is an increasing use in the clinical practice of new techniques for the treatment     of this condition and several surgical devices, characterized by minimally invasive approach,     are commercialized.      Recently, single-incision devices have been proposed. One of the most relevant potential     advantages of these devices is the possibility of performing their positioning under local     anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly     useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress     incontinence not associated to pelvic organ prolapse (POP) and women whose stress     incontinence raised after surgical correction of (severe) POP.      Poor data coming from randomized controlled trials (RCTs) are available regarding     single-incision devices for the treatment of stress incontinence, and there are no     conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no     randomized controlled trial is actually available in literature comparing different     single-incision devices.   "
221406|NCT00751101|"     RATIONALE: Nicotine patches may reduce hand-foot syndrome in patients receiving capecitabine     for metastatic breast cancer. It is not yet known which nicotine patch regimen may be more     effective in reducing hand-foot syndrome.      PURPOSE: This randomized clinical trial is studying which schedule of using nicotine patches     is more effective in reducing hand-foot syndrome in patients who are receiving capecitabine     for metastatic breast cancer.   "
221407|NCT00751114|"     The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin     in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment     period.      Secondary objective was to assess the effect of insulin glargine in comparison with     sitagliptin on:        -  HbA1c level        -  Fasting Plasma Glucose (FPG)        -  7-point plasma glucose (PG) profiles        -  Percentage of patients with HbA1c <7% and <6.5%      Safety objectives consisted of:        -  Hypoglycemia occurrence        -  Body weight        -  Overall safety   "
221408|NCT00751127|"     PhXA41 is not inferior to timolol   "
221409|NCT00751140|"     The primary objective is to show that performing a lymph node dissection may detect occult     nodal metastasis in this patient population whereby providing important diagnostic     information, with potential therapeutic benefits in patients with isolated nodal metastases.      In case of urothelial carcinoma of the upper urinary tract (a cancer originating from the     inner lining of the urinary tract) requiring the removal of the kidney, ureter, and cuff of     bladder (a surgical termed a nephroureterectomy). Previous studies in urothelial carcinoma of     the bladder, have shown that doing a lymph node dissection (surgically removing the lymph     nodes) may improve survival, or at least give an idea of what patients may need chemotherapy     (drugs to control the cancer cells that are outside the kidney-ureter) earlier (before the     nodes are enlarged in the imaging studies).   "
221410|NCT00751153|"     Subjects with HIV who have viral suppression on current regimen but also have side     effects/intolerance will change their current regimen to a combination of Raltegravir and     Atazanavir and be monitored for viral and immunological response and quality of life.   "
221411|NCT00751166|"     This was a randomized, double-blind, parallel-group, multicenter study that used both an     active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily     during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1     ratio.   "
221412|NCT00751179|"     A multi-center, randomized, parallel group, comparative, active controlled, safety assessor     blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine     alone in subjects undergoing short surgical procedures in out-patient surgicenters. The     primary objective was to evaluate changes in plasma potassium levels after treatment with     rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical     procedures in out-patient surgicenters.   "
224067|NCT00785252|"     Multicenter randomized study to compare powered intraosseous access to standard central line     access for the administration of fluids and drugs for patients in the Emergency Dept.   "
221413|NCT00751192|"     Men who have sex with men (MSM) account for the greatest burden of the HIV and Sexually     Transmitted Infection (STI) epidemic in Peru. Current interventions that promote early     identification and treatment of these diseases target a limited number of this population     because they rely solely on peer education. To assess the use of the Internet as an     alternative tool to reach this population the investigators propose to conduct an online     randomized controlled trial to compare the effect of HIV-testing motivational videos versus     standard public health text, both offered through gay websites. The methodology the     investigators will use is divided in: (1) the development period, where the investigators     will select gay websites for banner advertisement, create and refine effective recruitment     messages and design the online survey and the video-based intervention (2) the intervention     period, where participants who meet the eligibility criteria will be randomized into a video     or a standard public health text. The videos will be customized for three audiences based on     self-identification: gay, non-gay and trans and will be framed within the health-belief model     and the stages of change theory (3) in the outcome evaluation period we will compare the     'intentions to get tested' and 'time to HIV testing at the clinic' among MSM of each of the     trial arms. If the Internet is an effective venue to reach MSM for HIV testing, Peruvian     health programs that target this population may start considering the delivery of web-based     interventions and other online prevention services to this under served and hard-to-reach     population.   "
221455|NCT00738049|"     The primary objective of this study is to test the hypothesis that myocardial perfusion     heterogeneity, quantified by Markovian Homogeneity analysis of cardiac PET perfusion images,     will improve in a quantitative manner after treatment with selective ETA receptor antagonist     darusentan 100 mg per day for 2 weeks compared to baseline and post-treatment PET scans in     clinically stable subjects with coronary atherosclerosis and/or risk factors.   "
221414|NCT00751205|"     This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the     safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced     peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours     on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient     is benefitting. In addition patients will receive ALC or placebo, starting 1 week before     first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone.     Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be     determined by the incidence of all grades of peripheral neuropathy with the results of a     patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined     by the tumor response.   "
221415|NCT00751218|"     This was a randomized, double-blind, parallel-group, multicenter study that used both an     active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily     during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1     ratio.   "
221416|NCT00751231|"     This is a multi-center, randomized, double-blind, triple-dummy, clopidogrel-controlled study     of IV and oral PRT060128 compared to clopidogrel in patients undergoing non-urgent (including     elective) PCI. After diagnostic angiography, patients scheduled for non-urgent PCI will be     randomized to clopidogrel or to one of three dose levels of PRT060128.   "
221417|NCT00751244|"     The study is a randomized trial of two manualized 12-session one-to-one educational and     therapeutic interventions for post-traumatic stress disorder (PTSD), to test and compare     their efficacy for reducing PTSD symptoms as a means of prevention of intergenerational     victimization by or involvement in criminal activities with at-risk mothers. The two     therapies are (1) Trauma Affect Regulation: Guide for Education and Therapy (TARGET) and (2)     Present Centered Therapy (PCT). The study also included a wait-list comparison condition in     which participants were offered one of the two therapies following completion of baseline and     posttest assessments.   "
221418|NCT00751257|"     N-acetylcysteine is an inexpensive agent with a benign side effect profile with preliminary     studies in humans suggesting efficacy for the treatment of cocaine dependence.     N-acetylcysteine has been used in clinical medicine for nearly three decades to treat chronic     lung conditions, acetaminophen overdose, and experimentally to treat cocaine dependence. It     is generally safe and well tolerated. The present pilot study seeks to explore safety and     tolerability, ad lib smoking, visual cue reactivity, and smoking reduction rates in a group     of nontreatment seeking, nicotine dependence smokers who are willing to undergo a brief trial     with oral N-acetylcysteine 1200 mg twice daily.   "
221419|NCT00751270|"     This phase I study evaluated a Gene Mediated Cytotoxic Immunotherapy approach for malignant     gliomas, including glioblastoma multiforme and anaplastic astrocytoma. The purpose of this     study was to assess the safety and feasibility of delivering an experimental approach called     GliAtak which uses AdV-tk, an adenoviral vector containing the Herpes Simplex thymidine     kinase gene, plus an oral anti-herpetic prodrug, valacyclovir, in combination with standard     of care radiation.   "
221420|NCT00751283|"     The purpose of this study is to evaluate the safety and efficacy of the Minnow Medical GRST     Peripheral Catheter System in the treatment of new lesions in the superficial femoral artery     or the popliteal artery.   "
221421|NCT00751296|"     This study will assess the        -  efficacy (response rate) of oral lenalidomide in the treatment of patients with          symptomatic, previously untreated, chronic lymphocytic leukemia (CLL),        -  toxicity of lenalidomide in patients with CLL as well as time to progression, stable          disease duration and, if responses are observed, response duration.   "
221422|NCT00737620|"     The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis     access will develop stenosis at the venous anastomosis and eventually will fail. Aspirin have     been used for many years as a prophylactic drug therapy to prevent thrombosis but good     clinical evidence for its benefit is lacking. Many drugs have been used to reduce intimal     hyperplasia in animal models. Until recently there has been little success in clinical trials     of anti-inflammatory, antiproliferative, antiplatelet, antithrombotic or calcium channel     blocking drugs. Recently a major breakthrough was done by GORE when introducing the new     heparin bonded PTFE graft by covalent attachment. This trial is planed to assess and compare     between the GORE-TEX® PROPATEN vascular graft versus unmodified ePTFE grafts the patency and     complication.   "
221423|NCT00737633|"     This study is an extension of a study that has been ongoing for 1 year. The purpose of this     open label study is to see the how well type 2 diabetics respond to     VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an     extended period of time. All subjects eligible to enroll into this study will receive study     drug.   "
221559|NCT00744770|"     The purpose of this Phase I, open-label, single-sequence drug-drug interaction trial in     patients on stable methadone maintenance therapy is to investigate the potential interaction     between TMC278 25 mg daily and methadone, at steady-state.   "
221424|NCT00737646|"     This study is a three-arm randomized controlled trial to implement and evaluate the relative     effects of: 1) clinic-focused intervention; 2) combined patient- and clinic-focused     intervention, and 3) usual care on the provision of colorectal cancer (CRC) screening in     primary care clinics. The study will also examine the relative effects of the intervention     conditions on secondary behavioral outcomes (e.g., clinician-patient discussions about CRC     screening) and on intermediate outcome measures of attitudes, beliefs, opinions, and social     influence surrounding CRC screening among patients, clinicians, and clinical staff. The     target population includes average-risk patients aged 50-75 years, clinicians, and clinical     staff within the primary care setting. The intervention will be implemented within primary     care clinics in two managed care organizations (MCOs). The intervention targets the following     CRC screening modalities: fecal occult blood test (FOBT), flexible sigmoidoscopy,     colonoscopy, and double contrast barium enema.   "
221456|NCT00738062|"     The purpose of this study is to assess the durability of effect of Droxidopa in treating     symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure     (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic     neuropathy, or Beta Hydroxylase deficiency.   "
221457|NCT00738075|"     The investigators hypothesize that mathematical algorithm can identify freezing episodes     based on data obtained from accelerometer.   "
221425|NCT00737659|"     In order to avoid renal transplant rejection, the immune system should be suppressed. After     the renal transplant subjects are treated with a combination of two to four different types     of immunosuppressive drugs. Theses drugs are very efficient in the prevention of the renal     transplant rejection. Still, they can cause side effect.      Research in renal transplant tries to find the best treatment in order to avoid renal     rejection on one hand and to reduce as much as possible the undesired adverse and toxicity     effects on the other hand.      Therapeutic efficacy and the onset of adverse effects are influenced by levels of     mycophenolic acid (MPA, the active metabolite of MMF, CellCept®).      The primary objective of this study is to assess the treatment superiority of CellCept® Dose     Adjustment treatment, based on individual MPA concentration value monitored periodically,     against treatment with CellCept® Fixed Dose (standard care).   "
221426|NCT00737672|"     The objective of the study is to establish efficacy and safety of the GORE VIABAHN®     Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV)     prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of     vascular access for hemodialysis.   "
221427|NCT00737685|"     Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia as a part of the     conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found     to be more effective in preventing GVHD and rejection of organ transplants. As the     fludarabine based conditioning regimens without total body irradiation have been reported to     be promising for BMT/PBSCT from alternative donors in SAA, thymoglobulin was added to     fludarabine and cyclophosphamide conditioning to reduce GVHD and to allow good engraftment in     UBMT/UPBSCT.   "
221428|NCT00737698|"     Background Chronic Obstructive Pulmonary Disease (COPD) patients develop leg weakness and a     reduced walking capacity, due to reduced leg muscle oxygen-utilising capacity (OUC). Animal     experiments indicate that low muscle levels of Peroxisome Proliferator-Activated Receptors     (PPAR) cause the reduced muscle OUC.      Aims      In COPD patients, investigate whether:        1. reduced muscle PPAR levels cause reduced leg muscle OUC, by investigating a correlation          between these in muscle samples (Study 1).        2. training increases muscle PPAR levels in proportion to increases in OUC, as should occur          if PPARs control OUC (Study 2).        3. muscle PPAR levels and walking capacity correlate (Study 1 and 2).      3. the new technique of repetitive stimulation of the nerve to the leg with a magnet (rMS)     improves muscle OUC (Study 2).      Study 1 Leg weakness and walking ability are assessed in 75 patients, then a leg muscle     sample is taken to measure PPARs and OUC.      Study 2 60 Study 1 patients have either cardiovascular training, rMS, or no training, for 8     weeks, then are re-studied as in Study 1.      Importance If reduced PPAR levels correspond with leg weakness, medicines can be developed to     target these receptors and treat weakness. If rMS is effective, it can be offered to     patients.   "
221429|NCT00737711|"     This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and     tolerability of two-weekly intravenous administration of Mircera in dialysis patients with     chronic renal anemia not currently treated with ESAs. Patients will receive intravenous     Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last     treatment visit. The anticipated time on study treatment is 3-12 months, and the target     sample size is 100-500 individuals.   "
221430|NCT00737724|"     The purpose of this study is to evaluate and compare the efficacy of immediate antiretroviral     therapy versus 2 month deferred anti-Tb therapy upon the clinical course of tuberculosis and     HIV infection in patients with AIDS and active tuberculosis.   "
221431|NCT00737737|"     This study will examine hormone function in men with osteoarthritis pain and how it is     affected by opioid medication (such as Percocet, Vicodin, MS Contin and morphine) versus     placebo.      Men between 30 and 65 years of age who have had moderate to severe osteoarthritis joint pain     at least 5 days a week over the past 3 months may be eligible for this study. Candidates are     screened with a physical examination, x-rays, laboratory and other tests, and questionnaires     about pain, mood and medical health. They are given a pain diary to complete for 2 weeks.      Participants are admitted to the hospital for two 12 hour overnight stays, during each of     which they provide a 24-hour urine collection and have a small blood sample drawn every 20     minutes for 12 hours (from 8:00 p.m. to 8:00 a.m.) through a catheter that remains in place     in a vein. Blood pressure and pulse are monitored during this time. After the catheter is     removed, subjects complete questionnaires about their pain, mood and activity.      For the several weeks between the two hospitalizations, subjects take either an opioid     medication or placebo, or standard medication such as motrin and naprosyn, according to     random assignment to one of the three groups. All participants will be allowed to take     anti-inflammatory medications and acetaminophen during this time as needed, but no other pain     medications or treatments. They are monitored two or three times a week by telephone and     complete a pain diary.      After the second hospitalization, subjects are tapered off the study medication. After 2 to 4     weeks of stopping medication, they return for a final outpatient visit to review pain or     other medical problems and to have blood drawn.   "
221471|NCT00743613|"     Erectile dysfunction is a common complaint and is found frequently in men with     hyperlipidemia, hypertension, diabetes and those who smoke. ED may also be an early warning     of peripheral arterial disease. This study is designed to look for a relationship between the     degree of ED and the presence of PAD when associated with co-morbid conditions.   "
224147|NCT00779272|"     The objective of this study is to evaluate for the first time not only the impact of     neoadjuvant chemotherapy on clinical outcome, but also on liver regeneration after liver     resection.   "
221454|NCT00738036|"     To define a rational pharmacological management of pain for the subjects under opioid     maintenance therapy (methadone or buprenorphine), it is first of all necessary to estimate     the efficiency of the current practices on pain management as well as their potentially     noxious consequences, in particular on the long term opioid maintenance therapy.      The objective of the study is to compare the efficiency of the opioid maintenance therapy     according to the arisen of an acute painful phenomenon requiring an analgesic management for     these patients. At first, this work will allow to determine the results on acute pain of the     current practices for these patients. The comparison of the long term consequences on opioid     maintenance therapy between the patients that presented an acute painful phenomenon and the     control patients should help to improve acute pain management for these patients while     limiting the risk of relapse in the abused consumption of psychoactive substances.   "
221432|NCT00737750|"     Prospective, controlled, randomized, single blind study in patients undergoing rehabilitation     following anterior cruciate ligament reconstruction. 96 patients were randomly assigned to     one of three groups. Group Group KH (Kneehab n=33)trained with a new type of garment     integrated NMES for 20 minutes, 3 times per day, 5 days per week for 12 weeks; Group PS     (Poli-Stim n=29) trained with standard neuromuscular electrical stimulation (NMES) for 20     minutes per day, 5 days per week for 12 weeks; Group CO (Control - n=34), which did not use     muscle stimulation, performed voluntary isometric quadriceps muscle contractions. Patients     receiving either form of NMES treatment were instructed to isometrically contract the     quadriceps muscle voluntarily with each electrical muscle stimulation. All three groups     superimposed this training schedule on the standard post-ACL reconstruction rehabilitation     protocol used at the clinic.      The study design corresponded to a two-way variance analysis with three groups and 4     examination times (Baseline, 6 weeks, 12 weeks and 24 weeks post ACL reconstruction). The     level of significance was set at 5%. The key indicators of the quadriceps muscle training     intervention were the isokinetic strength development of the extensors of the injured leg at     90 degrees/second and 180 degrees/second and the distance achieved by participants performing     the single-leg hop, the shuttle run. The target was to show a difference of 10% in the     relative distance jumped for the single-leg hop and for the isokinetic strength tests and a     1.2 second difference in the time to complete the shuttle run. The target of 3 weeks was set     for participants to achieve full weight-bearing capability with use of a walking aid. A     comparison between the groups of the time for return to usual work activities was planned.   "
221433|NCT00737763|"     In this single-center therapeutic study, we will study the ability of efalizumab to protect     remaining beta cells in teenagers and young adults who have been newly diagnosed with type 1     diabetes mellitus. Efalizumab is a monoclonal antibody which prevents the activation of     antigen specific T lymphocytes to sites of inflammation. Efalizumab was approved by the FDA     in 2003 for the treatment of psoriasis. It has been proven to be safe, well tolerated and     effective in targeting T cell mediated disorders like those seen in autoimmunity.   "
221434|NCT00737776|"     This study is conducted in Asia. The aim of this observational study is to evaluate the     efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical     practice conditions in Korea. A clinical safety profile will be also evaluated.   "
221435|NCT00737789|"     The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily     (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses     (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks,     in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI)     score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema     containing 1g of mesalazine at bedtime during the initial 4 weeks.      Participants in remission at week 8 received an additional 4 weeks of maintenance therapy     with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8     completed the study at week 8.   "
221436|NCT00737802|"     The purpose of this study is:        -  To study the components of the gastroesophageal junction high-pressure zone individually          and as a group, by pharmacologically eliminating or accentuating the pressure profile          generated by the smooth muscle components.        -  To differentiate the gastric sling fibers from the clasp fibers based on the spatial          orientation of these muscle groups.   "
221437|NCT00737815|"     The investigators recent epidemiologic work in several national surveys and cohorts of men     and women have shown that dietary patterns high in plant-based foods and phytochemicals are     associated with lower plasma levels of insulin, triglycerides, and C-reactive protein, and     reduced risk of type 2 DM and CHD. While the physiologic impact of different foods on serum     glucose and insulin is of critical importance, the extent to which specific dietary nutrients     can modify insulin resistance is not well understood. Magnesium is a biologically active     constituent in whole-grain, green leafy vegetables, and nuts and appears to play an essential     role in hundreds of physiologic processes in humans. However, it remains uncertain whether     magnesium intake can exert effects on insulin sensitivity and inflammation. Moreover, little     is known of the extent to which magnesium intake elicits changes in the expression levels of     key genes responsible for glucose homeostasis and systemic inflammation. The ultimate     clinical question is whether magnesium supplementation would be clinically effective for the     improvement of metabolic disorders in not yet diabetic but high-risk individuals, especially     those who are susceptible to insulin resistance. Therefore, as a direct follow up on our     previous work in studying the health benefits of plant-based foods such as whole grains,     fruits and vegetables, we propose a pilot randomized trial to unravel the metabolic and     anti-inflammatory effects of magnesium supplementation versus placebo among overweight     individuals with the metabolic syndrome who are particularly prone to the adverse effects of     magnesium deficiency. Recent advancements in molecular genetics and genomic technologies have     also enabled us to analyze the expression levels of thousands of genes simultaneously in     different experimental conditions. The application of high throughput microarray technology     in randomized-controlled setting when analyzed with novel statistical methods, will not only     help our understanding of nutrient-disease relations, but also afford the investigators the     opportunity to gain important insight into the molecular mechanism for complex biological     systems of inflammation, insulin resistance, and metabolic abnormalities in response to     nutrition intervention.   "
221438|NCT00737828|"     The investigators would like to evaluate the use of cardiopulmonary exercise tests (CPX) in     guiding the care pathway of patients undergoing colorectal operations. In the intervention     group care will be guided by CPX results and in the control group care will be guided by the     doctors assessment. The investigators would like to assess the impact of this on patient     outcome, patient satisfaction and resource usage.   "
221439|NCT00737841|"     There has been no data on effect of Bifidobacterium breve on symptoms of patients with     irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on     symptoms of IBS patients.   "
221453|NCT00738023|"     Insulin resistance has been implicated as the central pathogenetic feature of cardiovascular     risk factor cluster that includes hypertension, impaired glucose tolerance, diabetes,     dyslipidemia, and hemostatic disorders. Recent evidence suggests that increased levels of     free fatty acids (FFA) in obese subjects is a leading candidate in the pathogenesis of     insulin resistance (1-4). In our preliminary studies on the effect of FFA on insulin     secretion and action (lipotoxicity), we have observed that the infusion of Intralipid/heparin     to increase FFA ~ four-fold-baseline levels for 48 hours results in a significant and     reproducible raise in systolic and diastolic blood pressure (BP) in obese African American     subjects with and without diabetes. The increase in blood pressure is apparent after 12 hours     of infusion, reaching a peak increment of 32 mm Hg in systolic and 14 mm Hg in diastolic     pressure at 24 hours. These preliminary findings indicate that, in addition to the well-known     effect on insulin resistance, sustained elevation of FFA results in the development of an     acute metabolic syndrome.   "
221440|NCT00737854|"     Oral lichen planus is a common chronic mucocutaneous disease with various clinical forms.     Erosive-ulcerative forms usually cause symptoms of pain and discomfort. The most important     complication of OLP is development of oral squamous cell carcinoma, although this is a very     controversial matter. various treatments have been suggested for OLP but their results are     unsatisfactory. Through the experiences of the investigators, corticosteroids (in any form)is     not a wise option for treating OLP and has many side effects . More over, immunosuppressive     therapy did not influence the risk for oral cancer. The purpose of the study is to determine     the efficacy of free soft tissue graft in the treatment of precancerous and symptomatic     lesions of OLP. Removal of the lesions up to submucosa has been done. The graft sliced from     healthy mucosa also up to submucosa. Then graft will be sutured in position.      According to other authors, basal epithelial layers of the graft remain intact and represent     the focus of re-epithelization. New epithelial cells migrate over the basal membrane and     appear to guide it by proliferation, will generate new epithelium. The wound is     re-epithelialized by proliferation of surrounding healthy epithelial cell, therefore, not     contaminated by modified antigens of the cell membrane that are theoretically responsible for     lymphocyte aggression. The healthy graft remains free of lesions and appears clinically     healthy.   "
221441|NCT00737867|"     The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is     better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung     cancer, in terms of survival, quality of life and need for palliative radiotherapy.   "
221442|NCT00737880|"     Graft preservation in clinical pancreas transplantation is based on hypothermia achieved by     topic cooling and cold in situ flushing using special perfusion solutions designed to     attenuate the effects of ischemia/reperfusion and prolong cold ischemia tolerance.      For pancreas transplantation, University of Wisconsin (UW) solution is the most commonly used     perfusate. However, over the last years, Histidine-Tryptophan-Ketoglutarate (HTK) solution     has been increasingly used for abdominal organ procurement. Retrospective reports published     so far have demonstrated the safety of both perfusion solutions.      However, to date, no prospective study comparing both perfusion solutions has been published.     Aim of this study was to prospectively evaluate early pancreas graft function in clinical     pancreas transplantation after organ perfusion with HTK vs. UW solution.      The study hypothesis is that HTK is not inferior to UW for organ perfusion during procurement     in clinical pancreas transplantation.   "
221443|NCT00737893|"     This research study aims to explore the effectiveness of human erythropoietin versus placebo     in promoting the recovery of erectile function in patients undergoing bilateral nerve-sparing     radical retropubic prostatectomy for clinically localized prostate cancer.      Pre-clinical studies have shown erythropoietin potently promoted recovery of erectile     function in rats and humans have similar receptors on penile tissues and the periprostatic     neurovascular bundles. A clinical non-randomized study conducted in men undergoing radical     prostatectomy demonstrated a benefit to recovery of erectile function.      Therefore, the hypothesis is that erythropoietin offers nerve protection in men undergoing     nerve-sparing radical prostatectomy and results in a reduced degree of erectile dysfunction     and also an improved rate of erection recovery following surgery.   "
221444|NCT00737906|"     The primary goal of this post-marketing surveillance study is to assess whether surgical     turbinate reduction performed using a Coblation® device is associated with reduced nasal     obstruction symptoms.   "
221445|NCT00737919|"     This study aims to explore whether the increased supply of dietary plant sterols and plant     stanols have any influence on serum levels of phytosterols and on consistency of carotid     atheromatous plaques.   "
221446|NCT00737932|"     The study aims to evaluate the safety and clinical effect of daily oral treatment of     Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess     Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is     a novel immunomodulating drug which is currently in advanced stages of development by Teva     Pharmaceuticals Ltd. for Multiple Sclerosis.   "
221447|NCT00737945|"     The investigators test the additional clinical value of the physiological assessment of     endothelial function to the morphological assessment of coronary complexity and classical     risk score in predicting cardiovascular events.   "
221448|NCT00737958|"     The purpose of this study is to determine whether exposure to diesel exhaust (air pollution)     has a functional impact on patients with stable angina pectoris.   "
221449|NCT00737971|"     Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema   "
221450|NCT00737984|"     Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles   "
221451|NCT00737997|"     The purpose of this study is to examine if morphine administered by bolus before initiating     Remifentanil by infusion decreases the incidence of acute post-operative opioid tolerance as     demonstrated by decreased post - operative morphine consumption in children undergoing     scoliosis surgery.   "
221452|NCT00738010|"     Prospective, controlled, randomized, single blind study in patients undergoing rehabilitation     following anterior cruciate ligament reconstruction. 96 patients were randomly assigned to     one of three groups. Group Group KH (Kneehab n=33)trained with a new type of NMES with     multipath activation for 20 minutes, 3 times per day, 5 days per week for 12 weeks; Group PS     (Poli-Stim n=29) trained with standard neuromuscular electrical stimulation (NMES) for 20     minutes per day, 5 days per week for 12 weeks; Group CO (Control - n=34), which did not use     muscle stimulation, performed voluntary isometric quadriceps muscle contractions. Patients     receiving either form of NMES treatment were instructed to isometrically contract the     quadriceps muscle voluntarily with each electrical muscle stimulation. All three groups     superimposed this training schedule on the standard post-ACL reconstruction rehabilitation     protocol used at the clinic.      The study design corresponded to a two-way variance analysis with three groups and 4     examination times (Baseline, 6 weeks, 12 weeks and 24 weeks post ACL reconstruction). The     level of significance was set at 5%. The key indicators of the quadriceps muscle training     intervention were the isokinetic strength development of the extensors of the injured leg at     90 degrees/second and 180 degrees/second and the distance achieved by participants performing     the single-leg hop and the time to complete the shuttle run. The target was to show a     difference of 10% in the relative distance jumped for the single-leg hop and for the     isokinetic strength tests and a 1.2 second difference in the time to complete the shuttle     run. The target of 3 weeks was set for participants to achieve full weight-bearing capability     without use of a walking aid. A comparison between the groups of the time for return to usual     work activities was planned.   "
221466|NCT00743548|"     The study's purpose is to find an easy and effective alternative to dental floss for those     persons who cannot or choose not to dental floss so that they can maintain and/or achieve     optimal oral health. The study hypothesis is that the inter-dental brush is as effective as     dental floss for removing plaque from between the teeth and for reducing bleeding gums in     persons with gingivitis, but may be easier to use and thus encourage daily home use.   "
221458|NCT00738088|"     The study hypothesis is that people who respond well to sulphonylureas have a different     underlying cause for their diabetes than people who respond poorly to this medication. We are     using two approaches to study this. In one approach we look at people who have previously     responded well or poorly, confirm this by rechallenging them with a sulphonylurea drug, and     then looking at how well they produce insulin in response to glucose and an intravenous     sulphonylurea called tolbutamide. The second approach identifies people with a certain     genetic predisposition to diabetes (due to changes in the TCF7L2 gene) and then looks at how     well they respond to sulphonylurea medication.   "
221459|NCT00738101|"     To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated     cholestasis to receive Omegaven for compassionate use situations for which there are no     satisfactory alternative treatments.   "
221460|NCT00738114|"     High blood glucose levels in surgical patients with and without diabetes are associated with     increased risk of medical complications and death. Over the short-term, high blood glucose     can adversely affect fluid balance, impair immunologic response to infection, and promote     inflammation and endothelial dysfunction (blood vessel function). Blood glucose control with     intensive insulin therapy in patients with critical illness (very sick patients in intensive     care unit) reduces the risk of multiorgan failure and systemic infections, and decreases     short- and long-term mortality. High blood glucose has also been associated with poor outcome     in non-critically ill patients admitted to general surgical and medical wards; however,     intensive glycemic control is not aggressively pursued because of fear of hypoglycemia. A     computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966     to 2008 provided very little information on the prevalence and outcome of high blood glucose     during the perioperative period (before and after surgery) in non-critically ill patients.     Therefore, the present study aims to evaluate the impact of high blood glucose, in large     number of subjects with and without diabetes, during general (non-cardiac) surgery.   "
221461|NCT00743483|"     The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and     pancreatic insufficiency following treatment with BSSL   "
221462|NCT00743496|"     Relapsed and/or refractory neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma are     considered difficult to treat and cure. For this study we are testing the use of a new     experimental (investigational) antibody called hu14.18K322A. GD2 is expressed on the surface     of most of these tumor types.      Two schedules of hu14.18K322A antibody will be evaluated in this study, (1) daily for four     consecutive days schedule every 28 days and (2) once weekly for 4 weeks schedule every 28     days. Approximately 25-40 participants will be required to define the maximum tolerated dose     for each schedule. Participants will continue on treatment for a maximum of 4 to 8 courses or     until one or more of the criteria for off-treatment are met.   "
221463|NCT00743509|"     The purpose of this Phase II study will assess the effectiveness of the combination of oral     cyclophosphamide and sirolimus in sarcoma patients with relapsed or widespread disease who     cannot be cured by surgery, radiation or conventional chemotherapy.   "
221464|NCT00743522|"     Although shock therapy is effective in terminating ventricular tachycardia (VT), it can be     painful to the patient and repetitive shocks can decrease a patient's quality of life.     Previous studies have suggested that one or more sets of aggressive device parameter settings     may reduce the total number of shocks in primary prevention patients. In addition to shock     therapies, antitachycardia pacing (ATP) is also available in ICDs to treat VT. The PROVIDE     trial aims to prospectively study the effect of high detection rates, prolonged detection     intervals, aggressive SVT discriminators, and extensive ATP therapy in prolonging the time to     first shock in primary prevention patients.   "
221465|NCT00743535|"     The incidence of anterior pelvic defect in women is estimated about 10% and it may be often     associated to urinary stress incontinence. To date the correction of anterior defects with     the use of graft material inserted with transobturator approach has become of large use.     Moreover, given the frequent association of urinary stress incontinence to anterior defect,     in most of cases it becomes necessary to perform at the same time an anti-incontinence     procedure, i.e. a sub-urethral sling positioning. Based on these considerations the aim of     this trial will be to compare two different approach for sub-urethral sling positioning,     transobturator and transvaginal tape (TOT and TVT) performed in association to transobturator     correction of anterior defect with mesh in terms of efficacy and safety.   "
221467|NCT00743561|"     The purpose of this study is to determine whether ambulatory polygraphy during a short     hospitalization in a neurology unit has the same performance than inpatient polysomnography,     the actual gold standard, in the diagnosis of sleep apnea in patients suffering from multiple     system atrophy (MSA).   "
221472|NCT00743626|"     The principal hypothesis of this study is that HPV testing and/or p16 testing, either alone     or in combination or associated with a Pap smear, will demonstrate greater specificity for     clinically significant precancerous disease than will a Pap smear alone and that these tests     will be of comparable or superior sensitivity than the Pap smear.   "
221473|NCT00743639|"     This study describes a controlled randomized clinical trial to evaluate the efficacy of bone     marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy     and cardiac failure class III or NYHA.   "
221474|NCT00743652|"     This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal     conjugate vaccine in Alaskan Native Children.   "
221475|NCT00743665|"     The primary aim of this study is to characterize the quality of life of youth with Cyclic     Vomiting Syndrome (CVS) as well as the strategies they use to cope with stress, their     strengths and vulnerabilities, and to assess symptoms of depression and anxiety in these at     risk youth. The impact of CVS on the child's parent and family will also be assessed.      A second aim is to evaluate the associations among coping strategies, personal strengths and     vulnerabilities and the frequency and intensity of CVS attacks to determine if particular     coping styles and personal characteristics are associated illness severity, psychiatric     co-morbidity and quality of life   "
221476|NCT00743678|"     An innovative therapeutic strategy to increase the complete resection rate is of utmost     importance in order to enhance survival in colorectal cancer patients with unresectable     liver-only metastasis. Therefore, the investigators propose a prospective study of     neoadjuvant chemotherapy using FOLFOX6 plus cetuximab to convert initially unresectable liver     metastasis to potentially resectable disease.   "
221477|NCT00743691|"     The purpose of the study is to determine whether community based management of infections     with antibiotics administered by health extension workers reduce all cause mortality in     neonates after the first day of life compared to current MOH IMNCI model of referral to     hospital   "
221478|NCT00743704|"     The primary objective of this pilot study is to establish a model of neutrophil airway     inflammation for future testing of anti-inflammatory substances in an early stage of clinical     development. Moreover, the suitability of an electronic nose for early detection and     diagnosis of airway inflammation will be determined.   "
221479|NCT00743717|"     The aim of this study is to provide evidence that the safety and effectiveness of the ceramic     femoral component of the Gem Total Knee System is similar to FDA approved implants used in     total knee replacement surgery. The hypotheses to be tested are that the investigational and     control groups are equivalent in terms of patient success rate and complication-free rate.   "
221480|NCT00743730|"     The purpose of this study is to compare, the safety, efficacy and level of parent and nurse     satisfaction with three methods of opioid administration post-operatively in children (4-18     years of age) with developmental delay.   "
221481|NCT00743743|"     Objective: To determine the effects of resveratrol extract given in a 215 mg dose in a daily     supplement currently available over the counter, on cognitive and global functioning in     patients with mild to moderate AD on standard therapy.   "
221482|NCT00743756|"     The purpose of this study is to assess the impact of home-delivered Medical Nutrition Therapy     on clinical outcomes for persons with diabetes. The primary outcomes of this studies include     A1c (A1C), blood glucose, blood pressure, Body Mass Index, lipid levels and other measures of     disease progression and management as well as costs of medical care provided throughout the     intervention period.   "
221483|NCT00743769|"     The purpose of this study is to determine whether the intravenous administration of single-     and multiple-ascending doses of Thymosin Beta 4 is safe and tolerable in healthy volunteers.   "
221484|NCT00743782|"     This study will evaluate the safety, biological activity, and pharmacokinetics of PTH     delivered by subcutaneous injection compared with an infusion pump. We anticipate pump     delivery of PTH will be more physiologic because it mimics normal parathyroid gland secretion     of PTH. We expect that pump delivery will simultaneously normalize blood and urine calcium,     phosphorus and magnesium levels with minimal or no fluctuations throughout the day. Pump     therapy will require lower PTH doses and should normalize markers of bone turnover. We expect     the improved metabolic control during pump therapy will be especially evident in patients     with more severe forms of hypoparathyrodism where there is an unmet need for improved     therapy.   "
221485|NCT00743795|"     The purpose of this study is to compare the safety, tolerability and effectiveness of the     experimental drug GS-9190 when administered for 24 or 48 weeks with peginterferon alfa 2a and     ribavirin for the treatment of genotype-1 chronic hepatitis C infection.   "
221486|NCT00743808|"     Twelve health organizations from around the US were selected to participate in a chart review     Hypertension and Diabetes Initiative with the goal of improving blood pressure control in     persons with diabetes.      Hypothesis:      A three-phase quality improvement initiative facilitated and monitored through the     International Diabetes Center (IDC) will result in improved population-mean systolic blood     pressure in the aggregate data pool of patients from all 12 participating sites at     geographically distinct health systems.   "
221487|NCT00743821|"     The purpose of this study is to validate and refine a diagnostic device that can detect     attention and memory deficits that result from mild traumatic brain injury (mTBI).   "
221488|NCT00743834|"     This study will test the hypotheses that: 1. 12 weeks of Luvox-CR plus web-based     Cognitive-Behavioral Therapy (CBT) [CT-STEPS] will produce greater symptom relief of OCD than     treatment with Luvox-CR alone; and, 2. subjects receiving 12 weeks of CT-STEPS added to     Luvox-CR treatment after 12-weeks of Luvox-CR monotherapy will experience greater OCD symptom     relief (from weeks 12-24) than those continuing Luvox-CR treatment and having access to     CT-STEPS from week one. 3. subjects who begin CT-STEPS at week 12 will be more likely to     complete it than those who begin CT-STEPS at baseline.   "
221489|NCT00743847|"     The primary objective of this protocol is to assess the efficacy of two dose strengths of     varenicline (0.5 mg BID and 1mg BID) as adjunctive treatment for cognitive impairment in     symptomatically stable outpatient schizophrenic subjects who are receiving treatment with     atypical antipsychotic medications.      A secondary objective is to evaluate the safety and tolerability of two doses of varenicline     in symptomatically stable schizophrenic subjects who are receiving treatment with atypical     antipsychotic medications.   "
221497|NCT00743951|"     Ministries of Health consider wait lists for total joint replacement a top priority. Research     priorities to manage wait lists indicate the need to establish benchmarks that consider     patient preferences. However, patients' preferences for hip or knee replacements are strongly     associated with their misperceptions of the indicators for, and the risks and benefits of,     these procedures. These misperceptions can be corrected with the use of patient decision     aids. When decision aids are used in combination with assessing surgical eligibility, there     may be a reduction in unnecessary referrals for surgery either because the patient is     ineligible or because the eligible candidates make informed decisions to forgo this option.      The study objective is to pilot test the feasibility of a trial evaluating the effects of     patient decision aids on reducing unnecessary surgical referrals for total joint replacement,     when used in combination with a general practitioner run clinic to screen patients with hip     or knee osteoarthritis for surgical eligibility.      The investigators expect to provide evidence of feasibility (e.g. ease of recruiting     patients, delivering the interventions, measuring patient outcomes) and sample size needed     for a larger scale study. This study should also provide evidence for planning implementation     of the interventions and standardized training across other centers.   "
221498|NCT00743964|"     Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed     promising results in randomized clinical trials for advanced gastric cancer (AGC). The     objective of the study is to evaluate the safety and activity of ECX and CX combination     chemotherapy given as first-line therapy for AGC.   "
221499|NCT00743977|"     The present study aims at comparing the pharmacokinetics of the original formulation of     phenazopyridine and a same generic product.   "
221500|NCT00743990|"     This study seeks to subjectively evaluate whether a single application of Vicks® VapoRub®     (VVR) ointment or a control ointment (petrolatum) will be superior to no treatment for     control of nocturnal cough and congestion due to upper respiratory tract infection (URI) as     rated by both parents and children.   "
221501|NCT00744003|"     Trauma continues to be the major killer of young Americans, mainly due to hemorrhage or brain     injury. In trauma centers, up to a quarter of these severely injured patients arrive with a     coagulopathy and thereby experience an increased risk of death, despite the current standard     of medical and surgical management. The PI for this grant proposal is a fellowship-trained     trauma surgeon who works full-time at Grady Memorial Hospital (GMH), the only Level I Trauma     Center in Atlanta. It is only one of four Level 1 trauma centers for the entire state of     Georgia. This research is a direct extension of the retrospective research the PI has     previously published. Her retrospective research discovered a previously undescribed form of     coagulopathy, early trauma induced coagulopathy (ETIC), which cannot be explained by present     paradigms. Two civilian trauma articles as well as military data from the Iraq war have     substantiated the occurrence of ETIC, but no prospective literature has defined it or its     kinetics. More importantly, the results from these studies represent a new paradigm shift, in     which ETIC appears to be a primary dysfunction which is independently associated with death.     Therefore, its early identification and correction is crucial for our mechanistic     understanding, and ultimately, our choice of interventions and improved survival. GMH is a     high-volume trauma center that sees patients with a variety of injury mechanisms, and,     therefore, is the perfect setting to confirm ETIC. First, the project will confirm the     prevalence of ETIC with an observational prospective cohort of injured patients. Data on the     coagulation system and risk factors, both known and suspected, of all patients will be     collected upon patient arrival as well as patient outcome with all identifying information     protected. This is the first prospective research project that will allow simultaneous     control of confounders associated with outcome and thereby scientifically validate the     occurrence of ETIC. One unique component of our data collection is a focus on the timing of     events as they relate to the development and consequences of coagulopathy, to account for the     dynamic process. At the completion of data collection, a matched cohort of ETIC and non-ETIC     blood samples will be tested for coagulation factors to provide insight into ETIC's     pathophysiology. In the short term, our conclusions will assist us in our approach to     resuscitation of the bleeding trauma patient as some trauma centers have already started to     change protocols based on our present incomplete understanding of trauma-induced     coagulopathy. In addition, the coagulation system data collected in this study will lead to     pathophysiological answers and to more refined hypotheses for future research at a     coagulation system level. Ultimately an understanding of ETIC will lead to a more effective,     tailored treatment. Our main study hypothesis is that post-trauma coagulopathy is a primary     dysfunction that occurs early after a traumatic event in up to 25% of all trauma patients     triaged to Trauma Center care.   "
221502|NCT00744016|"     The purpose of this study is to compare the maintenance of mild to moderate ulcerative     colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day     versus placebo.   "
221503|NCT00744029|"     In patients with acute stroke, systemic thrombolysis needs to be administered within three     hours of symptom onset. The aim of the present study was to reduce prehospital delays in a     population-based intervention.The intervention consisted of an educational letter indicating     stroke symptoms and emphasizing the importance of calling the emergency medical services     (EMS). The investigators additionally included a bookmark and sticker with the EMS telephone     number. A total of 75,720 inhabitants received the intervention. Between 2004 and 2005, 741     patients with cerebrovascular events were admitted from the control areas (n=24) and 647 from     the intervention areas (n=24).   "
221504|NCT00744042|"     This clinical trial studies the safety and efficacy of asfotase alfa in infants and young     children with infantile onset HPP.   "
221505|NCT00744055|"     Prazosin is an alpha-1 adrenergic receptor antagonist that has been used successfully in the     treatment of trauma nightmares and sleep disturbance in combat veterans with PTSD, and     alcohol dependence.      The objective of this study is to evaluate the efficacy of prazosin (16mg) versus placebo in     reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and     PTSD.   "
221506|NCT00744068|"     The overall objective of this research is to develop and refine empirically supported     continuing care interventions that promote healthy behavior and sustained abstinence from     illicit drug use.   "
221507|NCT00744081|"     The purpose of this study is to show superiority in complete responses of combination therapy     MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control     which was treated with MTC alone.   "
221508|NCT00744094|"     In the present study the investigators aim to determine whether protein supplementation can     augment the response to a 12 week resistance training program in healthy elderly men.   "
221509|NCT00744107|"     To demonstrate the safety and efficacy of the Cobra Cobalt Super Alloy Balloon-Expandable     Coronary Stent System for the treatment of de novo and restenotic (previously unstented)     lesions in native coronary arteries in subjects with coronary artery disease (CAD) having a     reference vessel diameter (RVD) between 2.5 - 4.0 mm and a lesion length ≤ 26 mm amenable to     percutaneous coronary intervention (PCI) with a single stent in subjects with symptomatic     ischemic heart disease.   "
221510|NCT00744120|"     This follow-up protocol is designed to evaluate participants who have previously been     lymphoma patients treated on approved clinical studies of the National Institutes of Health.   "
221511|NCT00744133|"     The purpose of this study is to determine how many infected mosquito bites are required to     reliably give volunteers a case of malaria. It is expected that volunteers will develop     malaria and may have symptoms. Safety is the main concern. A malaria challenge is given by     allowing a volunteer to receive 1, 3, or 5 mosquito's bites. Then participants are carefully     followed and blood is tested. The study will also look at how immune systems (the cells and     substances that protect the body from infection and foreign matter) respond after mosquito     bite challenges. About 38 subjects (aged 18-40 years) from the greater Baltimore, Maryland     (United States) community will participate and may stay overnight for 10 days at a local     medical center. Procedures include medical screening, assignment to a dose group, a mosquito     bite challenge, and 56 day follow-up. Volunteers will be contacted by telephone at 6 and 12     months after the malaria challenge.   "
221528|NCT00744354|"     RATIONALE: Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Bortezomib may also stop the growth of multiple myeloma     by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin     hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving doxorubicin hydrochloride     liposome together with vorinostat and bortezomib may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and to     see how well it works when given together with bortezomib and doxorubicin hydrochloride     liposome in treating patients with relapsed or refractory multiple myeloma.   "
221512|NCT00744146|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     immunogenicity of Protexia, an experimental drug being developed to protect soldiers against     the effects of nerve agents.      Volunteers will be entered into one of five groups. Four of the groups will receive a single     intramuscular dose of Protexia or saline placebo on Study Day 1 and will participate in the     study for approximately 71 days. One of the groups will receive two intramuscular doses of     Protexia or saline placebo - one dose on Study Day 1 and the second dose on Study Day 72.     This group will participate in the study for approximately 142 days.      All volunteers will remain at the study site as an inpatient for three days after they are     dosed and will be monitored closely by the study doctors and staff. After that, volunteers     will return to the study site as outpatients at predetermined intervals. Groups 1, 2, 4, 5     will have a total of 6 follow-up visits and Group 3 will have a total of 12 follow-up visits.      It is expected that this study will provide important information on the safety and     tolerabiity of Protexia at one and two doses.   "
221513|NCT00744159|"     This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer     surgery compared to open colon surgery.   "
221514|NCT00744172|"     The purpose of this study is to analyze prospectively all hysterectomies performed in Finland     for benign indications including all 46 public hospitals performing hysterectomies and also 7     private clinics. Hypothesis is that vaginal and laparoscopic hysterectomies are safe and     cost-effective methods of hysterectomy.   "
221620|NCT00751582|"     Supplementary feeding and intensive IEC at the community level will effectively reduce     moderate PEM compared to the control children within 3 months .      Intensive nutrition education at the household level will reduce by at least one third of the     prevalence of moderate malnutrition (40% of present level) within a short period of 3 months   "
221515|NCT00744185|"     The investigators observed that Propranolol, a beta-blocker commonly used in children was     efficient to control the growth of alarming hemangiomas of the face.      The primary objective of this study is to determine the efficiency of 1 month-early treatment     of propranolol in infants aged less than 4 months affected by an hemangioma without any     consequences on vital or functional structure and not justifying corticosteroids.      The secondary objectives are:        -  the kinetic of the hemangioma evolution in infants treated by propranolol        -  Observance        -  Safety   "
221516|NCT00744198|"     The treatment of urinary stress incontinence with trans-obturator approach, know as     transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and     safety of this minimally invasive surgery have been demonstrated, also in comparison with     similar procedures, i.e transvaginal tape (TVT).      To date the results of TOT in terms of efficacy and safety described in literature mainly     refer to procedure in which synthetic materials are used, whereas few data regarding the use     of biological materials are available. Moreover, despite the well known benefits of the     available synthetic and eterologue kit, their use may be limited by the high cost of these     materials. At this proposal it can be suggested as alternative option the possibility to     perform the procedure using an autologous tissue, i.e. rectus fascia, and reusable     introductory needles. Based on these considerations the aim of this trial will be to compare     autologous, synthetic and biological mesh for TOT in women with urinary stress incontinence.   "
221517|NCT00744211|"     Aim 1: The purpose of this study is to test the hypothesis that the release of endothelin     (ET) (protein), is directly involved in the induction/activation of MMPs (cardiac enzymes).     MMPs released during and following Coronary Artery Bypass Grafting may result in different     heart abnormalities after surgery. It is hoped that by measuring this protein and these     enzymes, new protective treatments for the heart during surgery will be discovered, which     could improve the safety of heart surgery for all patients. It is important that you     understand why the research is being done and what it will involve. Please take time to read     the following information carefully and discuss it with your family, friends and your doctor     if you wish. Please ask questions if anything is unclear or if you would like further     information. Take time to decide whether or not you wish to take part.      Advanced age is a recognized risk of cardiac surgical procedures, such as coronary artery     bypass grafting (CABG). Since you are having coronary artery bypass grafting surgery, your     heart will be connected to a perfusion pump that acts as your heart to pump blood throughout     your body during the surgical procedure. After surgery, your heart cells may not work     correctly which may cause an increase in the risk of death or sickness. The cause of this is     most likely by events happening inside your heart cells and mechanisms outside your heart     cells. The changes in structure and function around and in the heart cells have been observed     in the stopping and starting of blood during heart surgery and appear to be caused by the     start up of proteins around heart cells called matrix metalloproteinases (MMPs). Earlier     results from our laboratory and others have provided evidence that increased MMPs and their     naturally occurring inhibitors, tissue inhibitors of metalloproteinase (TIMPs), which stop     MMPs are released in patients having a heart attack or stopping of the heart and coronary     artery bypass grafting. Past studies have shown that changes will occur outside your heart     and vascular system, as well as in other tissues due to age and MMP expression.      Endothelin is a protein that is made in a number of cell types within the cardiovascular     system. Endothelin has properties that cause arteries to tighten and decrease blood flow     after surgery that can have direct negative effects, i.e. an increase blood pressure.     Clinical studies have reported that high endothelin levels in the early post-cardiopulmonary     bypass (post-CPB) period can be associated with problems after surgery.      Aim 2: The purpose of this study is to demonstrate that Sitaxsentan Sodium, which is an     endothelin inhibitor is administered through the vein and reduces the activation of MMPs,     which are cardiac enzymes that cause different heart abnormalities following surgery.      Advanced age is a recognized risk of cardiac surgical procedures, such as coronary artery     bypass grafting (CABG). Since you are having coronary artery bypass grafting surgery, your     heart will be connected to a perfusion pump that acts as your heart to pump blood throughout     your body during the surgical procedure. After surgery, your heart cells may not work     correctly which may cause an increase in the risk of death or sickness. The cause of this is     most likely by events happening inside your heart cells and mechanisms outside your heart     cells. The changes in structure and function around and in the heart cells have been observed     in the stopping and starting of blood during heart surgery and appear to be caused by the     start up of proteins around heart cells called matrix metalloproteinases (MMPs). Earlier     results from our laboratory and others have provided evidence that increased MMPs and their     naturally occurring inhibitors, tissue inhibitors of metalloproteinase (TIMPs), which stop     MMPs are released in patients having a heart attack or stopping of the heart and coronary     artery bypass grafting. Past studies have shown that changes will occur outside your heart     and vascular system, as well as in other tissues due to age and MMP expression.      Endothelin is a protein that is made in a number of cell types within the cardiovascular     system. Endothelin has properties that cause arteries to tighten and decrease blood flow     after surgery that can have direct negative effects, i.e. an increase blood pressure.     Clinical studies have reported that high endothelin levels in the early post-cardiopulmonary     bypass (post-CPB) period can be associated with problems after surgery.      Sitaxsentan sodium (pronounced sy-TAX-sen-tan, and called sitaxsentan) is an endothelin     receptor blocker, which prevents the negative effects caused by endothelin. Sitaxsentan is an     experimental medication and has not been approved by the FDA (Food and Drug Administration)     for the purpose mentioned.   "
221518|NCT00744224|"     The purpose of this study is to explore whether the GLP-1 receptor agonist exenatide, may     prevent glucocorticoid-induced glucometabolic abnormalities and beta-cell dysfunction in     healthy subjects.   "
221519|NCT00744237|"     This study will evaluate the effects of nebivolol on glycemic control compared with     metoprolol and HCTZ in patients with hypertension and type 2 diabetes mellitus   "
221520|NCT00744250|"     The purpose of this research study is to learn about the activity of oral Pancrecarb® (a     pancreatic enzyme preparation which contains proteins that help to digest food), administered     by mouth as a capsule filled with specially coated granules in patients taking exogenous     pancreatic enzyme therapy. Specific enzymes activities will be determined from samples of     stomach and intestinal fluids after a standard liquid meal.   "
221521|NCT00744263|"     The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate     vaccine in the prevention of the first episode of vaccine-type pneumococcal     community-acquired pneumonia in adults.   "
221522|NCT00744276|"     The purpose of this study is to determine the safety of three doses of topically applied     danazol compared to placebo in subjects with pain associated with fibrocystic breast disease     and to determine the appropriate clinical dose for future studies.   "
221523|NCT00744289|"     Aims:      This prospective trial seeks to investigate the efficacy of a financial incentive in     increasing the uptake and completion of the HBV vaccine series among people who inject drugs     (PWID). Using a randomised controlled trial design, the investigators will offer the 3 dose,     accelerated HBV schedule to eligible PWID allocated to either a standard of care or incentive     condition. Participants allocated to the incentive condition will receive a small incentive     payment after the second and third dose of the vaccine. It is hypothesized that the     proportion of participants who complete the vaccine series in the incentive payment arm will     be higher compared to the non-incentive payment arm (standard of care).   "
221524|NCT00744302|"     A prospective, randomized, controlled multicenter trial to evaluate 1.25 mmol/L     (physiological) vs. 1.5 mmol/L calcium dialysate on serum markers of mineral metabolism,     secondary hyperparathyroidism and cardiovascular calcification in prevalent haemodialysis     patients. And the long term safety of the 1.25 mmol/L calcium dialysate was also considered.      There are two phases of study for each subject. Phase 1 (screening phase). During this phase,     each potential subject will be evaluated to determine if he/she is eligible for the study.      Phase 2 (intervention phase). Each subject will be randomly allocated to physiological     calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium     dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36     months.   "
221525|NCT00744315|"     Human Vascular Endothelial Grown Factor 165 (hVEGF165) administration is promising therapy     induces a new vessels, arterioles and capillaries in regions whose revascularization surgery     is not possible by direct or by percutaneous angioplasty. This study aims to evaluate the     clinical effects and safety of gene therapy with hVEGF165 in patients with advanced coronary     artery disease.   "
221526|NCT00744328|"     The purpose of this study is to determine whether estrogen patches are effective for the     treatment of postpartum major depression, as compared to sertraline (Zoloft) and placebo.   "
221527|NCT00744341|"     The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart     failure patients with renal dysfunction.   "
221529|NCT00744367|"     This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by     HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus     pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to     one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after     4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable     metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be     switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of     taspoglutide 10mg once weekly. The anticipated time on study treatment is 1-2 years, and the     target sample size is 100-500 individuals.   "
221530|NCT00744380|"     The purpose of this randomized, double-blind study is to evaluate the utility, safety, and     cost of transitioning benzodiazepine sedation to dexmedetomidine in medical or surgical     intensive care unit (ICU) patients requiring sedation when tracheal extubation is nearing.     Fifty medical or surgical ICU patients requiring sedation with existing benzodiazepine     therapy and qualifying for daily awakenings will be randomized in a double-blind manner to     receive additional midazolam or dexmedetomidine.   "
221531|NCT00744393|"     The purpose of this study is to determine what effect sodium oxybate has on the functions of     sleep in mechanically ventilated, critically ill patients hospitalized in an intensive care     unit.   "
239626|NCT00995813|"     The purpose of this study is to assess the safety and immune response of the rotavirus     vaccine in infants who have undergone abdominal surgery.   "
221532|NCT00744406|"     Depression affects over one million people in Canada, resulting in $14.4 billion per year in     costs to Canadian society. In order to prevent this often lifelong disorder, it is critically     important to identify risk factors for the recurrence of depression. A crucial force in     maintaining depression is the generation of stressful life events. That is, individuals who     have a history of depression are likely to generate the very events that precipitate future     depressive episodes (e.g., relationship break-up, fired from job, conflicts with the law) due     to negative personality characteristics and disrupted social support networks resulting from     previous episodes. This project is the first to test a model that examines the role of     negative personality, low social support, and childhood abuse and neglect as risk factors for     the generation of stressful life events that predict future depression. We will test this     model in a group of patients meeting formal criteria for depression who will be treated and     then followed up for 12 months or until depression recurrence. With this long-term design we     will be in a unique position to understand how depression is maintained over time, thus     suggesting important treatment strategies to prevent depression recurrence.   "
221533|NCT00744419|"     The purpose of this study is to determine how the body uses and eliminates pantoprazole, a     drug used to treat GERD. This is a pharmacokinetic (PK) study. PK is a measure of how much     drug is in the blood and how long it takes to leave the body. It is hypothesized that younger     infants will need a lower dose than older children to achieve the same PK measurement.      The results of this study will be used to determine the best dose of the drug to use in each     age group. Pantoprazole is a drug used to decrease acid production. The use of pantoprazole     has not been approved for use in children. Pantoprazole is approved for use of acid-related     and stomach disorders in adults.   "
221534|NCT00744445|"     The purpose of this research study was to determine if the activity of erythropoietin     (r-HuEPO) is time dependent when given to chronic renal failure patients at three different     times of day.   "
221535|NCT00744458|"     The purpose of this study is to determine the efficacy of three different interventions to     improve treatment adherence among patients with arterial hypertension or diabetes in rural     Cameroon.   "
221536|NCT00744471|"     The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in     osteoarthritis of the hip in patients   "
221537|NCT00744484|"     The purpose of this study is to determine whether water based or land based group training is     more effective for people with COPD.   "
221538|NCT00744497|"     The purpose of this study is to determine whether survival can be prolonged in patients with     castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.   "
221539|NCT00744510|"     Polycystic Ovary Syndrome (PCOS) is very common, affecting approximately 5% of women of     reproductive age, and impacts not only on quality of life, but also has long-term health     consequences for many sufferers, such as increased risks of developing Type II diabetes,     cardiovascular disease and cancer of the womb. The symptoms that may occur such as irregular     periods; lots of body hair; thinning hair on scalp, obesity and infertility, can also lead to     poor self-esteem. Whilst treatments can help fertility, other treatments to correct the other     symptoms are less successful. Alternative methods to regulate periods would be helpful,     especially ones which avoid the long-term use of steroids in patients who may already be     overweight. Reflexology is poorly represented in scientific papers, with nothing published     regarding reflexology and its effect upon PCOS. However patients who use reflexology report     more regular periods, thicker hair on scalp and greater wellbeing. Therefore we aim to     investigate the effect of reflexology on:        1. The menstruation cycle (normal being every 21-35 days).        2. Imbalances in hormone, insulin and blood sugar levels associated with PCOS.        3. Other problems associated with PCOS such as thinning hair on scalp, excessive body hair,          and obesity.        4. Quality of life. Government and NHS agendas agree that if there's evidence of an          effective complimentary therapy the NHS should provide it. Therefore the results may          have an influence on the care pathways of patients with PCOS towards a more holistic,          patient centred and empowered approach. It is also non invasive and liable to result in          higher patient satisfaction regarding their treatment. This research may also inform          policy makers so that complementary medicine provision is provided on a wider basis          within the NHS, which at the moment is dictated by the individual Trust's budget          allocation. However this research could save money overall as in America, the yearly          cost of treating PCOS is $4.36 billion.   "
221540|NCT00744523|"     The objective of the ARMOUR study is to evaluate the safety and effectiveness of the Mo.Ma     proximal flow blockage cerebral protection device for patients at high surgical risk for     carotid endarterectomy who undergo carotid artery stenting   "
221541|NCT00744536|"     Angiogenesis increases in higher risk MDS patients and those with proliferative CMML.     Angiogenesis is associated with increased risk of leukemic transformation and poorer     prognoses. Low dose chemotherapy may have anti-angiogenic properties by targetting the     genetically stable endothelial cells. Lenalidomide has been recently shown to be highly     effective as monotherapy in low/low-intermediate risk MDS, particularly in the subgroup     harboring a 5q- deletion. Lenalidomide has not been well studied in higher risk MDS although     there are some reports of lenalidomide's efficacy in RAEB-T and AML. One potential mode of     action of lenalidomide is inhibition of angiogenesis. The investigators hypothesize that by     combining lenalidomide with low dose melphalan in higher risk MDS the investigators will more     effectively block angiogenesis and achieve responses or hematologic improvement in MDS.   "
221543|NCT00744562|"     This is an open-label Phase 1 dose escalation study of OMP-21M18 in subjects with previously     treated solid tumors for which there is no remaining standard curative therapy and no therapy     with a demonstrated survival benefit. Up to 30 subjects will be enrolled at up to 4 centers.     Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and     efficacy. No formal interim analyses will be performed. Prior to enrollment, subjects will     undergo screening to determine study eligibility. Upon enrollment, subjects will receive     weekly intravenous (IV) infusions of OMP-21M18 for 9 weeks. After 9 weeks of treatment,     subjects will be assessed for disease status. If there is no evidence of disease progression     or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-21M18     every other week until disease progression.      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). The dose     levels of OMP 21M18 will be 0.5, 1.0, 2.5, 5, and 10 mg/kg administered IV weekly for 9     doses. No dose escalation or reduction will be allowed within a dose cohort. The dose may be     administered at any time during the day. Three subjects will be treated at each dose level if     no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experience a DLT, that     dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further     subjects will be dosed at that level and 3 additional subjects will be added to the preceding     dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be     assessed for DLTs from the time of the first dose through 7 days after administration of the     4th dose, but prior to administration of the 5th dose (i.e., Days 0-28). Dose escalation, if     appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT     assessment.   "
221624|NCT00751634|"     There are few treatments for central fever (fever that is due to the central nervous system,     as opposed to an infectious source). We hypothesize that an externally applied cooling     blanket will reduce temperature in neurologically ill patients with central fever.   "
240842|NCT01000922|"     Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal     injections of individual doses of the study insulins.   "
221544|NCT00744575|"     The purpose of this study is whether patients suffering from chronic back pain for more than     one year will show a specific neurophysiological pattern in the EEG. This pattern is referred     to as Thalamo-Cortical Dysrhythmia (TCD) and consists most likely of a self sustaining loop     between the Cortex and Thalamus. This pattern has been found before in patients with very     severe chronic pain. Specific lesions to the Thalamus result in a reduction of this pattern     and decrease in pain. With this study the investigators will assess whether this pattern can     be found in back pain patients of different types. Patients will be measured by EEG for the     existence of TCD and will undergo detailed pain and psychological diagnostic.   "
221545|NCT00744588|"     This proposal is part of the INIA Stress Consortium. This study will        1. explore the contributions of lifetime trauma, recent stress, and alcohol use on          stress-hormone axis disruption in treatment seeking, one-month abstinent,          alcohol-dependent subjects        2. assess the combined contributions of stress-hormone axis disruption and episodic stress          on the risk of prospective drinking following treatment        3. determine the role of neurosteroids in alcohol use.   "
221546|NCT00744601|"     The purpose of this study is to assess neurocognitive and associated neural regions/circuitry     disruptions relevant to impulsive relapse in cocaine-addicted subjects, and the relationship     of the cognitive and neural mechanisms of impulsivity/decision-making to relapse style.   "
221547|NCT00744614|"     The purpose of this study is to evaluate the use of Capnography (Continuous recording of the     carbon dioxide content of expired air)as an alternative test to measure PC02 levels in     patients with asthma, chronic obstructive pulmonary (COPD,interstitial lung disease(ILD)or     coronary disease who are at risk of intubation.   "
221548|NCT00744627|"     The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily     (QD), in adults with Generalized Anxiety Disorders.   "
221549|NCT00744640|"     Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic     cancer (APC). Recent randomized trials have shown increased clinical benefit with the     addition of oxaliplatin and prolonged median survival with the addition of capecitabine to     gemcitabine. Gemcitabine, capecitabine and oxaliplatin are 3 newer, well tolerated anticancer     drugs with mild and non-overlapping toxicity profiles. We therefore propose a dose-finding     and safety study of the triple combination gemcitabine, capecitabine and oxaliplatin in     patients with APC (Phase I part), followed by a phase II part to assess preliminary efficacy     of this triple combination.   "
221550|NCT00744653|"     By applying short electric pulses to cells, the cell membranes can become permeabilised     (electroporation). This can be used augment the effect of chemotherapy, by providing direct     access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several     hundred fold, enabling once-only treatment. We wish to offer electrochemotherapy to breast     cancer patients suffering from chest wall recurrences that are ulcerated or painful and where     other treatments have failed.   "
221551|NCT00744666|"     Intravitreal triamcinolone acetonide (IVTA) is a commonly employed treatment for various     vitreoretinal disorders. However, approximately 23% to 50% of patients who receive IVTA     develop ocular hypertension after the drug is injected into the eye. Similar to IVTA,     topically administered corticosteroids eye drops result in ocular hypertension in     approximately 33% of the population. It is unknown whether identifying patients who develop     ocular hypertension from topical corticosteroids could be used to identify patients who are     at risk for injectable IVTA. Therefore, the purpose of this study is to evaluate the efficacy     of topical prednisolone 1% four times daily for one month as a screening test to reduce the     incidence and severity of ocular hypertension after IVTA injection.   "
221552|NCT00744679|"     The primary objective is to assess the pharmacokinetic (PK) profile of natalizumab (Tysabri)     at steady state.      The secondary objective is to assess the pharmacodynamics (PD) profile (α4 integrin     saturation) of Tysabri at steady state.   "
221553|NCT00744692|"     The primary objective is to determine the feasibility of attaining acceptable rates of donor     cell engraftment (>25% donor chimerism at 180 days) following reduced intensity conditioning     (RIC) regimens in pediatric patients < 21 years receiving cord blood transplantation for     non-malignant disorders.   "
221554|NCT00744705|"     The normal range of retinal nerve fiber layer thickness might be different between Asians and     Caucasians. However, the recently developed imaging device such as the Cirrus HD OCT includes     only the Caucasian data. So, the investigators want to find its normal range of in Asians.   "
221555|NCT00744718|"     This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients     with platin resistant ovarian cancer.   "
221556|NCT00744731|"     The purpose of this study is to obtain long-term safety and tolerability information on     carisbamate as add-on therapy for the treatment of partial onset seizures in patients with     epilepsy. Seizure counts will be obtained to measure the rate of seizures for each patient     during the study.   "
221557|NCT00744744|"     RATIONALE: Gathering information about quality of life in patients with cancer may improve     the ability to plan treatment and may help patients live more comfortably.      PURPOSE: This clinical trial is studying health-related quality of life in patients with     bladder cancer.   "
224148|NCT00779285|"     The purpose of this study is to evaluate the cardiac safety of Caelyx in patients with     metastatic breast cancer who have previously received chemotherapy with anthracyclines.   "
221560|NCT00744796|"     The purpose of this study is to report the early clinical outcomes in patients undergoing     Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) for corneal edema secondary     to corneal endothelial cell dysfunction, and to correlate this clinical data with the latest     generation of imaging modalities available for the anterior segment.   "
221561|NCT00744809|"     This is a study to evaluate the effect of TMC278 25 mg daily on the QT/QTc interval (heart     conduction and heart rhythm) in healthy volunteers. In a separate panel of healthy     volunteers, the effect of efavirenz (EFV) 600 mg daily on the QT/QTc interval will be     evaluated.   "
221625|NCT00751777|"     To evaluate and compare the immune responses and safety following a two vaccination regimen     by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or     placebo patches.   "
223876|NCT00782717|"     The purpose of this study is to determine whether nepafenac is safe and effective for     reducing the incidence of macular edema following cataract surgery in diabetic retinopathy     patients.   "
221562|NCT00744822|"     This study is a prospective, multi-center study. 50 lung transplant recipients will be     enrolled in the study. Subjects will be selected from lung transplant recipients, who have     undergone single or double lung transplantation during the last six months These patients     will undergo a baseline VRI recording prior to the interventional procedure and a follow-up     VRI at 1 hour after the interventional procedure. Furthermore, the patients will be recorded     at the designated follow-up periods of 1, 3 and 6-month (+ 7 days) post-baseline visit, as     well as before and 1 hour after any recurrent interventional procedure   "
221563|NCT00744835|"     This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the     safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative     treatment of symptomatic permanent atrial fibrillation.   "
221564|NCT00744848|"     Effective postoperative pain control to promote improved healing, faster patient     mobilization, shortened hospital stays, and reduced healthcare costs.   "
221565|NCT00744861|"     The purpose of this study is to determine whether using active low intensity pulsed     ultrasound as adjunct therapy following single level posterior instrumented lumbar surgery     increases the posterolateral success rate when compared to inactive (placebo) therapy.   "
221566|NCT00744874|"     The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency     of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal     atrial fibrillation. (PAF)   "
221567|NCT00744887|"     The objectives are to determine the effect of different ritonavir doses on darunavir (DRV)     oral exposure following once-daily oral dosing of DRV/rtv for 7 days, in order to establish     an optimal ritonavir boosting dose for DRV and to evaluate short-term safety and     tolerability.   "
221568|NCT00744900|"     NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease     management. Neurosurgery is not indicated in the majority of cases because of presence of     several lesions in the brain, failure of primary tumor control or presence of extra-cerebral     metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of     these patients in this situation is based on supportive care and whole-brain radiotherapy.     The place of chemotherapy for patients with good performance status was discussed for a long     time and it is now admitted. However, the place of new drugs such as pemetrexed, which is     currently used as a second line treatment for NSCLC, needs to be further studied. It is known     that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar     effectiveness when compared to other drugs associations commonly used in this indication. In     addition, Cisplatin with Pemetrexed probably present a better safety profile.      The present study is based upon the hypothesis stipulating that the association     cisplatin-pemetrexed will be at least as efficient as the others association currently used     for treatment of NSCLC and will present a better safety profile. The primary objective of     this study is overall response rate on brain metastasis according to RECIST criteria.     Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus     pemetrexed, safety profile, quality of life, neurological symptoms, overall survival.      The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II     study with the possibility of stopping the study early because of lack of efficacy.   "
221569|NCT00744913|"     The overall objective of this study is to assess the effectiveness of NRT (Nicoderm patches)     plus counselling treatment in women in the second and third trimester of pregnancy.   "
221570|NCT00744926|"     This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared     to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and     exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once     weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)     or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide     10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once     weekly). The anticipated time on study treatment is 1 year, and the target sample size is     100-500 individuals.   "
221571|NCT00744939|"     Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist     injection. Subjects will be screened within 48 hours of previously scheduled MRI, those     meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post     MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls     conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.   "
221572|NCT00744952|"     Assessing disease activity in people with Takayasu's arteritis is difficult, as most people     with the disease do not exhibit visible, measurable symptoms. Combination positron emission     tomography/computed axial tomography (PET/CT) is a particularly sensitive, accurate scanning     method that may improve researchers' ability to evaluate people with the disease. This study     will determine the effectiveness of PET/CT in assessing disease activity in people with     Takayasu's arteritis.   "
221573|NCT00744965|"     This is a randomized prospective trial which addresses the question of whether use of an oral     hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will     result in achieving euglycemia in a shorter period of time and, in turn, result in less     frequent maternal and neonatal morbidities. This study is designed to test the hypothesis     that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling     lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling     alone.   "
221594|NCT00745251|"     The primary objectives of this study are to evaluate the safety and efficacy of VI-0521     compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and     to assess the relative contributions of weight loss on parameters of OSA in these subjects.   "
221574|NCT00744978|"     1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure          of cognition in patients with mild to moderate Alzheimer's disease        2. Evaluate the effects of varenicline on clinically relevant measures including attention          and executive function, behavior, and clinician rated global change.        3. Evaluate the safety and tolerability of varenicline, relative to placebo, in patients          with mild to moderate Alzheimer's disease        4. Evaluate the pharmacokinetics of varenicline in patients with mild to moderate          Alzheimer's disease.   "
221575|NCT00744991|"     The purpose of the study is to determine the efficacy and safety of enzastaurin in patients     with CTCL who failed prior therapies.   "
221576|NCT00745004|"     Irritable bowel syndrome is a common condition affecting 1 in 10 of the population. About a     third of these suffer from diarrhoea, which severely impairs their quality of life. Previous     studies in Nottingham have suggested that some patients with diarrhoea may have an excess of     a chemical called serotonin in their gut. Serotonin stimulates secretion and propulsion in     the gut and contributes to diarrhoea. We are interested to see whether a drug, Ondansetron,     which blocks the effect of serotonin, would improve symptoms in patients with IBS and     diarrhoea. We think the drug may work better in people with a specific gene type so your     genetic makeup may be of influence and we would like to test this. Because IBS symptoms     fluctuate, one way to determine whether Ondansetron is effective is to perform a randomised     placebo controlled trial in which neither the patient nor the doctor knows which medication     is being taken in each part of the study.   "
221577|NCT00745017|"     Depression affects over one million people in Canada, resulting in $14.4 billion per year in     costs to Canadian society. In order to prevent this often lifelong disorder, it is critically     important to identify risk factors for the recurrence of depression. A crucial force in     maintaining depression is the generation of stressful life events. That is, individuals who     have a history of depression are likely to generate the very events that precipitate future     depressive episodes (e.g., relationship break-up, fired from job, conflicts with the law) due     to negative personality characteristics and disrupted social support networks resulting from     previous episodes. This project is the first to test a model that examines the role of     negative personality, low social support, and childhood abuse and neglect as risk factors for     the generation of stressful life events that predict future depression. We will test this     model in a group of patients meeting formal criteria for depression who will be treated and     then followed up for 12 months or until depression recurrence. With this long-term design we     will be in a unique position to understand how depression is maintained over time, thus     suggesting important treatment strategies to prevent depression recurrence.   "
221578|NCT00745030|"     Parkinson's disease (PD) is the second most common neurodegenerative disorder of the elderly     that affects a million patients in US. Sleep dysfunction impacts up to 90% of PD patients. PD     patients experience a variety of sleep disorders including parasomnias, specifically REM     behavior disorder (RBD) that can precede the onset of motor manifestations of PD. RBD has     negative consequences on patients' and their bed partners' quality of life mainly due to its     impact on the sleep quality and day time alertness. RBD also predisposes affected individuals     and their bed partners to physical injuries.      There are no FDA approved treatments for RBD. Clonazepam is the most commonly used treatment     but carries risks of daytime sedation, tolerance, and withdrawal symptoms. More recently,     melatonin has been demonstrated to be effective in several small studies. Ramelteon, a     selective melatonin receptor agonist with favorable safety profile, could potentially be     effective for the treatment of RBD.      This pilot protocol will investigate safety and efficacy of ramelteon for the treatment of     RBD in subjects with parkinsonism. We plan to recruit 20 subjects with RBD diagnosed based on     the clinical interview and confirmed by the polysomnographic (PSG) data. The study is     designed as a prospective randomized placebo controlled 12-week study. Primary outcome     measure will be change in frequency of RBD events based on the daily sleep diaries. Secondary     outcome measure will be change in the amount of tonic muscle activity based on the results of     the baseline and final PSG. A number of other secondary and exploratory outcome measures will     be collected   "
221579|NCT00745043|"     Smoking causes both smoking related lung disease (COPD) and ischaemic heart disease. These     are very common conditions and many patients have both diseases. Beta-blocker drugs are     extensively used in the treatment of angina, high blood pressure and after heart attacks to     decrease symptoms and prolong life. Beta-agonists are used in COPD to decrease breathlessness     and improve exercise tolerance. It used to be thought that beta-blockers cannot be used in     COPD patients as they may make the breathlessness worse, but it has now been established that     they can be used safely. Beta-blocker drugs and beta-agonists have 'opposite' effects on the     body and the investigators do not know if they can work together or if they would cancel each     other out. The investigators also do not know which of the different types of beta-blockers     now available are better for COPD patients. This study will investigate what happens to the     airways of people taking both of these drugs.   "
221580|NCT00745056|"     This is a prospective, observational study of the cohort of older post-menopausal     participants in the WHI Memory Study, a sub-cohort of participants in the WHI Hormone Trials.     Annual cognitive assessments and ascertainment of cognitive impairment enable the continued     monitoring of long-term effects of randomization to HT on cognition and identification of     predictors of cognitive vulnerability and resilience in older women.   "
221581|NCT00745069|"     The purpose of this study was to examine a low and high dose of tapentadol extended release     tablet taken orally twice a day to reduce pain in subjects suffering from chronic moderate to     severe pain due to osteoarthritis of the knee during a 4-week period. Subjects steadily     increased their dose up to the low (100 mg) or high (200 mg) dose. Pain relief was compared     to subjects taking placebo tablets or oxycodone extended release tablet, 20 mg. The serum     concentrations and safety of tapentadol and oxycodone were also examined.   "
221595|NCT00745264|"     -  Comparison of the plasma PK after single use of 100 mg ketoprofen from Diractin®. 50 mg          applied on 2 major joints to        -  400 mg ketoprofen from Diractin® (100 mg applied to 4 joints - overexposure)        -  100 mg and 400 mg ketoprofen from Diractin® used concomitant with heat application        -  100 mg and 400 mg ketoprofen from Diractin® used concomitant with moderate exercise   "
224265|NCT00793871|"     To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With     Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.   "
221621|NCT00751595|"     The study is a randomized, open label, phase II clinical trial directed at evaluating the     immunogenicity (as a primary end-point) and the safety (as a secondary end-point), of the     recombinant HIV-1 Tat vaccine in HIV-1 infected adult subjects, anti-Tat antibody negative,     HAART-treated with chronic suppressed HIV-1 infection, CD4+ T cell counts >= 200     cells/microliter, levels of plasma viremia < 50 copies/ml in the last 6 months prior to the     screening and without a history of virologic rebound. The immunogenicity of 3 or 5     immunizations of the two different vaccine doses (7.5 and 30 micrograms) of the Tat vaccine     has been evaluated.   "
221582|NCT00745095|"     The annual incidence of colorectal cancer in the US during 2005 was approximately 150,000     cases and this neoplasm claimed 56,000 lives (American Cancer Society). Detection (and     removal) of colonic polyps is now the central strategy in reducing the risk of colon cancer.     Thus, failure to detect and remove small cancers and polyps can have dire consequences.     Although it has not been shown that persons with spinal cord injury (SCI) have an increased     risk of this disease, there is no reason to assume that the incidence after SCI would be less     than that of the general population.      Colonoscopy would appear to be a better approach to colon cancer screening after SCI but may     also be unreliable if bowel evacuation is unsatisfactory for complete large bowel     visualization. Poor colonoscopic visualization is a major concern in persons with SCI because     they have long-standing difficulty with evacuation (DWE) and might not respond in a     predictable or satisfactory manner to the conventional bowel preparations used for     colonoscopy. Furthermore, to the extent that bowel preparation for colonoscopy is     unsatisfactory in persons with SCI, the putative benefits of colonoscopy in reducing colon     cancer mortality may not be realized.      In the absence of effective regimens for bowel preparation in persons with SCI, we suspect     that the documented benefits of screening colonoscopy in the able-bodied may not generalize     to persons with SCI. Regardless, these observations support the need for improved bowel     preparation approaches in persons with SCI. One such approach might involve the adjunctive     administration of prokinetic drugs to standard practices. A prokinetic agent that might be     beneficial in this context is neostigmine, an anticholinesterase inhibitor with prominent     parasympathomimetic actions (stimulation of peristalsis) on the colon. We have studied     neostigmine extensively in persons with SCI and have shown that, when given in combination     with glycopyrrolate, this approach to stimulate bowel evacuation is safe and effective for     bowel evacuation.   "
221583|NCT00745108|"     Tibolone has been registered for the treatment of climacteric symptoms and for the prevention     of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial     safety of tibolone in comparison with CE/MPA.   "
221584|NCT00745121|"     The overall objective of the study is to compare treatment with the ATRA TECH Implant System,     OsseoSpeed™ implant in the maxilla of postmenopausal women with and without systemic     osteoporosis. The hypothesis is that there will be no difference in marginal bone level     alterations between the two groups.   "
221585|NCT00745134|"     The goal of this clinical research study is to learn if combining a curcumin preparation with     standard radiation therapy and chemotherapy (capecitabine) can help to shrink or slow the     growth of rectal cancer. The safety of this combination and whether curcumin can help to     decrease some of the side effects of standard radiotherapy and chemotherapy will also be     studied.   "
221586|NCT00745147|"     The purpose of the study is to compare the therapeutic efficacy, safety, cost-effectiveness     and maintenance effect between Chinese herbal formula and lactulose on chronic constipation     in long-term care.   "
221587|NCT00745160|"     The purpose of this study is to determine if collecting information and blood from a group of     people who never smoked but who have lung cancer, is possible across the US. The     investigators will collect information on each patient's diagnosis and treatments. If the     collection is successful, blood samples will be used to try to identify new genes (which are     the basic elements of heredity, passed from parents to their offspring), which may explain     and predict why certain patients develop lung cancer without having smoked tobacco.   "
221588|NCT00745173|"     The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution,     breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet     when administered together with multiple doses of Premarin (conjugated estrogens or CE) to     healthy postmenopausal women.      Information will also be obtained regarding the safety and tolerability of this combination     in healthy, postmenopausal women.   "
221589|NCT00745186|"     The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic     bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy     volunteers.   "
221590|NCT00745199|"     Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent     information suggests that interactions between dermal mast cells and distal ends of     nonmyelinated C fibers may be important in the precipitation and regulation of the sensory     stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma     histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a     mast cell stabilizing agent that inhibits degranulation of mast cells and the release of     histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may     attenuate uremic pruritus by decreasing serum tryptase level.   "
221591|NCT00745212|"     The venous thromboembolism is one of the first causes of maternal mortality. Until 2003, only     a few recommendations were available on the optimal use of antithrombotic therapy as a     preventive measure against thromboembolism in pregnant women. In this study, we propose :        1. To gather the experts who took part in the French consensus conference and the local          experts to create a score in accordance with the national and international consensus          and to give some precise therapeutic strategies.        2. To evaluate the discriminant, feasible and useful character of this new score by a          random prospective multicentric study including 2280 pregnant women with a risk of          thromboembolism or placental vascular pathology who will benefit from therapeutic          strategies defined by the new score.   "
221592|NCT00745225|"     To study whether peroxisome proliferator-activated receptor-gamma activation in peritoneal     dialysis patients will reduce inflammation, atherosclerosis, calcification and improve     survival of peritoneal dialysis patients   "
221593|NCT00745238|"     Background: Myotonic dystrophy lead to highly heterogeneous, multisystemic symptoms including     myotonia, progressive muscle weakness, cardiac conduction defects, cataract, metabolic     dysfunction, and excessive daytime somnolence. This last symptom is related to respiratory     failure and/or to involvement of the central nervous system. However the metabolic     disturbances could contribute to it. From the respiratory point of view this disease is     characterised by the progressive appearance of respiratory failure of muscular origin but     mainly associated with a defect in the central respiratory drive. The treatment for this     hypoventilation is non-invasive ventilation (NIV).      It is not currently absolutely clear as to the best choice of criteria to judge long term     effectiveness of NIV. The most usual criteria are normalisation of daytime blood gases,     diminution of respiratory work, improvement in daytime symptoms and improvement in sleep     structure. Other criteria are currently little studied, for instance the contribution of the     interaction between alveolar hypoventilation and oxygen desaturation during the night and     biological deficiencies such as systemic inflammation, glucose intolerance or insulin     resistance. Likewise there is little information about the interaction between alveolar     hypoventilation and endothelial dysfunction and arterial stiffness both being accurate     predictive factors for cardiovascular risks.      Aim: to evaluate the impact of NIV on endothelial dysfunction in patients with myotonic     dystrophy. The secondary objectives are to assess the impact of NIV on systemic inflammation,     arterial stiffness, insulin-resistance, quality of sleep, and daytime vigilance in these     patients.      Methods: Patients with chronic alveolar hypoventilation already treated by long term NIV will     be included. They will have an initial check-up (Visit 1), then will interrupt NIV treatment     for four weeks (Visit 2), and then return to NIV treatment. The last check-up will be done     four weeks after NIV resumption (Visit3).      Expected results: It is expected that NIV withdrawal will results in a deterioration of     cardio-vascular parameters (endothelial function and arterial stiffness), metabolic     parameters (insulin-resistance and systemic inflammation), quality of sleep and daytime     vigilance. Return to NIV treatment may show an improvement of these parameters with a basal     state recovery.   "
241389|NCT01010932|"     The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering     from carotid or vertebral arterial disease.   "
221596|NCT00745277|"     1. Briefly describe the purpose of this protocol:             -  The purpose of this study is to see how low dose vs. high dose of the study drug,               carbidopa, effect movement in subjects with Parkinson's disease. The low dose of               the study drug is 75 mg and the high dose is 450mg.        2. Briefly describe the procedures subjects will undergo:             -  Subjects will take part in 2 screening visits one week apart to determine               eligibility. Subjects will be randomly chosen to start either high or low dose               carbidopa and take it for 4 weeks. Subjects will be called 2, 4, and 6 or 7 days               after this visit to ask how they are doing after starting this dose of study drug.               The investigators will leave subjects a message if the investigators cannot reach               them. If there are any problems, the investigators will schedule them to come to               the clinic within the next 2 days.             -  Subjects will have an outpatient visit 2 weeks after screening and a hospital               admission 2 weeks after that. At the hospital, subjects will stay for 3 days. They               will have blood drawn and their Parkinson's disease assessed by a finger tapping               exercise, timing their walking, and looking at their uncontrolled movements.             -  The subject will then receive the opposite dose of carbidopa for 4 weeks. Subjects               will be called 2, 4, and 6 or 7 days after this visit to ask how they are doing               after starting this dose of study drug. The investigators will leave them a message               if we cannot reach them. If there are any problems, the investigators will schedule               them to come to the clinic within the next 2 days.             -  The outpatient visit and hospital admission will repeat again. At the end of the               second hospital admission, treatment on the study is over and subjects will go back               to their original Parkinson's disease medications. The study will end with a follow               up phone call or clinic visit 2 - 4 weeks after the final hospital admission.        3. If applicable, briefly describe survey/interview instruments used.             -  Subjects will fill out a daily diary that asks about their movement throughout the               day for 3 days before they come to the Oregon Clinical and Translational Research               Institute.        4. Briefly describe how the data will be analyzed to address the purpose of the protocol.             -  Finger tapping rates will be compared between high and low dose study drug use to               see if one group has slower rates than the other.   "
221597|NCT00745290|"     The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine     HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.   "
221598|NCT00745303|"     Since Tai Chi Chuan (TCC) training has been shown to be beneficial to the cardiopulmonary     function of the subject, TCC might have a beneficial effect on the pulmonary function,     autonomic nervous modulation, lipid profile, and cytokines production in the aged subjects.   "
221599|NCT00751309|"     The objective of the LARGO Study protocol is to collect peripheral blood samples, select     associated lung biopsy pathology slides, and clinical data from lung transplant recipients to     perform molecular analyses in association with the study endpoints. The primary objective is     to use gene expression profiling of peripheral blood mononuclear cells to differentiate     between the absence and presence of acute cellular rejection. The secondary objectives are to     use other genomic and proteomic technologies to analyze RNA and protein in blood samples in     relation to related clinical conditions. The overall goal is to apply novel molecular     insights in the development of non-invasive molecular diagnostic tests for lung     transplantation.   "
221600|NCT00751322|"     Specific aim: To test whether transfusion of leukoreduced red cells of lesser storage time     (versus conventional storage time) reduces mild alterations in pulmonary function and immune     activation in critically ill patients with mechanically ventilated lungs.      We propose to perform a prospective, randomized, double-blind clinical trial in critically     ill patients whose lungs are mechanically ventilated, and who have orders to receive     transfusion of at least one unit of packed red cells, comparing pulmonary function between     patients randomly allocated to receive a unit of red cells stored for 5 days or less, with     similar patients randomly allocated to receive a unit of red cells stored conventionally     (median 21 days). We will test the hypothesis that transfusion of red cells of lesser storage     age, (5 days or less) will produce the less changes of pulmonary function and immune     activation than will transfusion of red cells of conventional storage age (median 21 days).   "
221601|NCT00751335|"     That ThermoSMart humidification will result in greater compliance (mask on time, objective     and subjective sleep quality than conventional humidification.   "
221602|NCT00751348|"     This Phase 3b study is being conducted for the purpose of registration of the GSK208136     vaccine in Korea.   "
221603|NCT00751361|"     Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry     age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of     therapeutic apheresis using the methodology of double filtration plasmapheresis to treat     microcirculatory disorders.   "
221604|NCT00751374|"     Catheter-related infection, namely exit site infection and peritonitis, is the commonest     complication of peritoneal dialysis. This complication causes significant morbidity and     mortality in patients requiring peritoneal dialysis. Topical application of mupirocin 2%     cream was first proven to be effective in reduction of staphylococcus-related catheter     infection in 1990s. Subsequent randomized trial published in 2005 showed that gentamicin     cream was superior to mupirocin 2% cream in reducing both Gram's positive and Gram's negative     related catheter infection. However, a retrospective report published in 2007 puts the use of     prophylactic antibiotic cream into a question. It reported an emergency of non-tuberculous     mycobacterial infection in a dialysis center in Hong Kong after practising prophylactic     application of gentamicin cream at the catheter exit site. The following prospective,     randomized and open-label study aims to find out an optimal regimen of topical antibiotic     prophylaxis in patients requiring peritoneal dialysis.   "
221605|NCT00751387|"     The study is a cross sectional, epidemiology study of disease severity for rheumatoid     arthritis, psoriatic arthritis and ankylosing spondylitis in four geographic regions in     Australia (Illawarra, Sutherland, Hunter Urban and Hunter Rural).   "
221606|NCT00751400|"     The purpose of this Study is to assess how subjects will use the investigational product in     an uncontrolled, naturalistic environment.   "
221607|NCT00751413|"     To evaluate the safety, tolerability and plasma levels of single oral doses of MK0633 in     pediatric asthma patients ages 6 to less than 12 years.   "
221608|NCT00751426|"     Psychiatric disorders or drug addiction are often regarded as contraindications against the     use of Interferon-alpha in patients with chronic hepatitis C. The investigators aim is/was to     get prospective data about adherence, efficacy and mental side effects of IFN-alpha treatment     in different psychiatric risk groups compared to controls. In a prospective trial, 81     patients with chronic hepatitis C (positive HCV-RNA and elevated ALT) and psychiatric     disorders (n=16), methadone substitution (n=21), former drug addiction (n=21) or controls     without psychiatric history or addiction (n=23) should be/were treated with a combination of     IFN-alpha-2a 3 x 3 Mio U/week and ribavirin (1000-1200 mg/day).   "
221618|NCT00751556|"     To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660     mg relative to the established commercial Aleve 220 mg tablet following single dose     administration and at steady-state following multiple dose administration for 4 days.   "
221619|NCT00751569|"     Umbilical cords contain immature blood cells, including a group of lymphocytes, that are     important in the so-called natural immunity. We want to study the cytokine levels in     umbilical cord NK cells and its regulation a family of newly identified small RNAs     (microRNAs).   "
221609|NCT00751439|"     The purpose of this his post-market, observational study titled Verification of Pulse     Oximetry in the Neonatal Population is to gather data to further support the accuracy of     Nonin's pulse oximeters when used in the neonate population. Neonates who are currently     undergoing arterial blood gas (ABG) sampling, as part of their medical care will be recruited     to participate in this study for collecting opportunity samples. Nonin's PureLight®     noninvasive sensor will be applied to a foot of the neonate; an adhesive wrap secures the     sensor to the neonate. The sensor immediately begins obtaining SpO2 and pulse rate     measurements which are sent to the oximeter module for display on the Electronic Data     Collection System (EDCS). At the time the prescribed ABG is drawn, the EDCS must have a     marker captured to identify the end of the ABG for SpO2 comparison. The SpO2 accuracy of     pulse oximeter will be measured by comparing SpO2 readings of the pulse oximeter to values of     SaO2 (opportunity samples) determined by a CO-oximeter.   "
221610|NCT00751452|"     determine the interest of the dosage of citrullinemia to monitor the bowel damage after     allogeneic bone marrow transplantation in children.   "
221611|NCT00751465|"     Blushing is associated with a heightened self-focused attention. In our study we are     interested if this self-focused attention can be shown experimentally and if it can be     changed by therapy and training. For the experimental part of the study, we want to compare     blushing fearful individuals to social anxious participants who are not fearful of blushing     and to healthy controls who report to blush either seldom or quite often. In the     therapeutical part of our study, we compare an attention training to the standard cognitive     behavioral therapy for social anxiety disorder in an intensive group therapy approach.   "
221612|NCT00751478|"     The purpose of the study is to determine the relative pharmacodynamic effects and safety of     crushed and whole ALO-01 compared to MSIR and to Placebo, and of crushed ALO-01 to whole     ALO-01; to determine the relative bioavailability of plasma morphine from crushed and whole     ALO-01 compared to MSIR, and from crushed ALO-01 to whole ALO-01; and to determine the     relative bioavailability of plasma naltrexone and 6-β-naltrexol from crushed ALO-01 to whole     ALO-01.   "
221613|NCT00751491|"     Percutaneous coronary intervention (PCI) is associated with up to 30% incidence of     myonecrosis, as reflected by elevation of cardiac enzymes in a successful procedure. Apart     from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of     myonecrosis after PCI might be distal embolization of atherogenic materials from plaque     disruption causing obstruction of blood ﬂow at capillary level resulting in micro-infarction.     Recent studies have suggested that pretreatment with adenosine in the cath lab and     Clopidogrel and statins greater than 6 hours before may be associated with a reduction in     infarct size after reperfusion therapy for acute myocardial infarction. Whether pretreatment     with adenosine decreases the incidence of myonecrosis in patients undergoing non-urgent PCI     is not fully known. The investigators propose that adenosine-induced hyperaemia can     potentially ameliorate the deleterious effects of distal embolization associated with     non-urgent PCI through dilatation of the microvasculature. Mechanistically, this may reduce     capillary obstruction by facilitating the throughput passage of embolized platelet thrombi     out to the venous end of the coronary circulation, thereby reducing the incidence of post-PCI     myonecrosis. In this prospective, randomized, open-label study, the investigators evaluated     the incidence of myonecrosis after non-urgent PCI with a treatment with intracoronary     adenosine compared with pretreatment of loading dose of Clopidogrel 300/600 mg >/< 6 hours.   "
221614|NCT00751504|"     Atypical antipsychotics have been found not only to be beneficial in the treatment of     psychotic disorders, but even for depressive symptoms in patients with schizophrenia.     Remarkably, preliminary data suggest that the atypical antipsychotic quetiapine has     antidepressive properties. Until now, there is limited knowledge concerning the efficacy of     quetiapine in major depressive illness and especially in psychotic depression. In our own     clinical practice, several patients with psychotic depression were successfully treated with     quetiapine as add-on therapy or as monotherapy. On the background of that, the convincing     effects of quetiapine in bipolar depression, single-case reports and pilot studies concerning     its effectiveness in depressive mood states in psychotic disorders as well as our clinical     experiences, it is to assume that a treatment with quetiapine over a 6 weeks period show     similar effects in major depressive episode with psychotic features, i.e. psychotic     depression. In this pilot study we plan to investigate 20 patients with psychotic features of     depression under treatment with quetiapine.   "
221615|NCT00751517|"     The Systemic Necrotizing Vasculitides (SNV) encompass a group of rare diseases which include     Wegener's Granulomatosis (WG), Churg-Strauss Syndrome (CSS), Microscopic polyangiitis     (MPA)and Polyarteritis nodosa (PAN). Common histological findings are inflammation with     fibrinoid necrosis of the small vessels and sporadic or absent immune-deposits. The gold     standard therapy for SNV is currently represented by the association of Cyclophosphamide and     Prednisone. The limits of this approach are the high frequency of recurrent disease and an     increased incidence of malignancy and infections. The aim of the present study is to compare     the efficacy of Methotrexate vs Cyclophosphamide for Remission Maintenance in SNV.   "
221616|NCT00751530|"     This is a retrospective chart review of participants in raltegravir expanded access program     and will compare virologic response in regimens not containing a protease inhibitor in the     antiretroviral background regimen to regimens containing a protease inhibitor in the     background regimen.   "
221617|NCT00751543|"     Lung cancer is one of the leading causes of cancer-related death in Taiwan. Recently, there     are more treatment methods available which result in increased patient survival. Although     adenocarcinoma and squamous cell carcinoma were both categorized as non-small cell lung     cancer (NSCLC), the recent advancement of target therapy implied that these two histologies     behave differently (Shah NT, et al. 2005; Sandler A, et al. 2006). Radiation therapy is an     important method for locally advanced non-resectable non-small cell lung cancer (NSCLC).     Computed tomography (CT) is the mainstay for evaluating lung cancer. The advance of multi-row     detector CT (MDCT) provides volumetric acquisition within a breath hold, and enables detailed     evaluation of tissue and organ perfusion with excellent resolution. Using this new technique     with image post processing, excellent spatial resolution and functional perfusion information     can be obtained simultaneously. Therefore, the purpose of this study is to explore not only     the longitudinal change of lung cancer eligible for radiation therapy (including concurrent,     sequential chemoradiotherapy and high-dose radiation therapy) but also comparison of     adenocarcinoma and squamous cell lung cancers using perfusion MDCT. Total twenty patients     with histopathologically proved adenocarcinoma or squamous cell carcinoma will be enrolled in     this study and receive longitudinal study for perfusion MDCT evaluation before, during     radiation therapy and in early and late phases after complete radiation therapy. Dynamic     perfusion will be used for processing the image data, and quantitative parameters such as     tumor blood volume and permeability etc will be derived. From this study, we expect to     understand the change of tumor vascularity after radiation therapy and characters of     treatment response of adenocarcinoma and squamous cell carcinoma in addition to the change of     tumor size.   "
221627|NCT00751803|"     The objective of this trial is to assess the safety, tolerability, and efficacy of three     doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache     pain of moderate or severe intensity, compared to placebo and an active comparator.   "
221628|NCT00751816|"     RATIONALE: Early physical therapy may be effective in improving range of motion of the neck     and shoulders in head and neck cancer survivors who are undergoing chemotherapy and radiation     therapy.      PURPOSE: This phase I trial is studying how well early physical therapy works in improving     physical and functional well-being in head and neck cancer survivors receiving     chemoradiotherapy.   "
221629|NCT00751829|"     To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan     medoxomil compared to nitrendipine in elderly and very elderly patients with isolated     systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil     compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of     treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week     treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure.     Efficacy and safety measurements are carried out at up to 15 visits during the trial period.   "
221630|NCT00751842|"     The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in     alum) is effective in preserving the body's own insulin producing capacity in patients     recently diagnosed with type 1 diabetes.      Based on results from other clinical trials with the study drug it was judged unlikely this     study would meet the intended primary or secondary efficacy endpoints. Therefore the primary     focus of this study was changed to ensure that safety data was available for at least 6     months following the last dose of active study drug. Thereafter the study was terminated.   "
221631|NCT00751855|"     This study seeks to examine the efficacy of hydrocortisone administration in the augmentation     of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested     treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD).     The augmentation builds on both the translation of neuroscience findings demonstrating the     effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other     investigators demonstrating beneficial effects of GCs in reducing traumatic memories in     trauma-exposed persons.   "
221632|NCT00751868|"     The purpose of this study is to assess the feasibility of Ixabepilone (4 cycles) administered     every 14 days with the support of G-CSF sequentially to the combination of Fluorouracil,     Epirubicin and Cyclophosphamide (4 cycles) administered every 14 days with the support of     G-CSF.      To evaluate the efficacy (in terms of pathologic Complete Responses in the breast and in the     axilla), the dose reduction rate, the median treatment delay and the discontinuation rate due     to toxicity of the regimen.   "
221633|NCT00751881|"     The primary objective of the study was to assess the effect of two doses of teriflunomide, in     comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants     with relapsing MS.      Key secondary objective was to assess the effect of the two doses of teriflunomide, in     comparison to placebo, on disability progression.      Other secondary objectives were:        -  To assess the effect of the two doses of teriflunomide in comparison to placebo on:             -  Fatigue;             -  Health-related quality of life, a measure of the impact of the participant's health               on his or her overall well being.        -  To evaluate the safety and tolerability of teriflunomide.   "
221634|NCT00751894|"     Hypothesis : pegfilgrastim at 200 µg/kg between 12 and 18 days after previous chemotherapy     provides an efficient stem cell mobilization in children with malignancies Design: phase 2     study. Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a     standard apheresis (less than 3 blood volume processed   "
221635|NCT00751907|"     The purpose of this study is to evaluate the hypothesis that in middle-aged, asymptomatic,     adult children of persons with Alzheimer's disease (AD), atorvastatin therapy will     beneficially affect mechanisms thought to contribute to AD risk by improving blood flow in     the brain, improving cerebral perfusion, increasing brain activity patterns, and improving     blood vessel function.   "
221779|NCT00753818|"     The purpose of this study is to compare the effects on visual development, growth, cognitive     development, tolerance, and blood chemistry parameters in term infants fed one of four study     formulas containing various levels of DHA and ARA.   "
221636|NCT00751920|"     The purpose of this study is to apply the techniques of dynamic MRI imaging enhancement to     research participants with one or more pulmonary nodule to determine if meaningful     information about the nature of the nodule can be obtained. This data will then be compared     with follow up information about nodule growth or histology obtained by biopsy or surgical     resection.   "
221637|NCT00751933|"     Ulcerative colitis is a chronic inflammatory bowel disease caused by an imbalance between     natural defence mechanisms in the intestinal mucosa and microbes in the intestinal lumen. We     hypothesise that an improvement or even normalisation of this balance may be achieved by the     use of vaccines and dietary oats. The combined use of oral typhoid vaccine and     cholera/ETEC-vaccine is supposed to stimulate mucosal defence factors, while dietary oats     modifies the microbial environment inside the intestinal lumen. Or study aim is to show if     such treatment brings symptom relief to patients with ulcerative colitis.   "
221638|NCT00751946|"     This study will compare treatment outcomes of 90 adolescent girls who are (a) at high risk     for delinquency and/or are juvenile justice involved, and (b) who are experiencing symptoms     of PTSD: 45 of the girls will receive Trauma Affect Regulation: Guide for Education and     Therapy (TARGET, Frisman, Ford, Lin, Mallon, & Chang, in press), and their outcomes will be     compared to 45 girls who receive Enhanced Treatment as Usual (ETAU). As part of their     involvement, participants will make phone calls to provide data via an interactive voice     response system (IVR), meet 3 times for a research interview, and be invited to participate     in a cognitive assessment substudy at the Olin Neuropsychiatric Research Center at Hartford     Hospital.   "
221639|NCT00751959|"     This study investigates the efficacy of surfactant application during spontaneous breathing     with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a     gestational age of less than 27 weeks.   "
221722|NCT00753038|"     The purpose of this Phase 2 study is to investigate whether intravenous administration of     REOLYSIN® therapeutic reovirus in combination with Paclitaxel and Carboplatin is effective     and safe in the treatment of squamous cell carcinoma of the head and neck.   "
221640|NCT00751972|"     The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD     System in patients listed for cardiac transplantation with refractory, advanced heart failure     at risk of death. The primary endpoint is survival at 180 days which is defined as alive on     the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. Patient     must survive 60 days post-explant for recovery to be considered successful. Secondary     endpoints include:        -  Overall survival        -  Incidence of all serious adverse events, neurocognitive status and unanticipated adverse          device effects.        -  Incidence of all device failures and device malfunctions        -  Quality of Life improvement, as measured by Kansas City Cardiomyopathy Questionnaire          (KCCQ) and EuroQoL EQ-5D        -  Functional status improvement, as measured by the New York Heart Association (NYHA) and          6-minute walk      The HeartWare® LVAD System was approved by the US FDA on November 20, 2012 as a bridge to     cardiac transplantation (reference PMA P100047). Patients enrolled into this study will be     followed to an outcome at six months, and then patients will receive continued follow-up in a     separate study.   "
221641|NCT00751985|"     The purpose of the study is to determine whether a web-based ultra-brief intervention,     consisting of personalized normative feedback or standardized self-help material, is     effective in lowering self reported alcohol use in heavy drinkers.   "
221642|NCT00751998|"     A prospective, multi-center registry for subjects undergoing Endoscopic retrograde     Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary     disease.   "
221643|NCT00752011|"     The goal of this clinical research study is to find the highest safe dose of the combination     of TAS-106 and carboplatin that can be given to patients with advanced cancer or cancer that     has spread.      Objectives:      Primary Objectives:      To determine the maximum tolerated dose (MTD) of the combination of TAS-106 and carboplatin     administered by intravenous infusion every 3 weeks.      To perform Pharmacokinetic (PK) analysis of TAS-106 and carboplatin      Secondary objectives:      To assess the antitumor activity of TAS-106 combined with carboplatin      To investigate the relationship between selected biomarkers and efficacy and safety outcomes.   "
221644|NCT00752024|"     The purpose of this study is to evaluate the superiority of effect of the modified     micro-invasive aspiration and drainage and conservative medical therapy in the treatment of     ICH spontaneously hypertensive scientifically.   "
221645|NCT00752037|"     A single center, open label, 48-week study of lopinavir/ritonavir in combination with     raltegravir. 30 patients, both naïve and experienced, will be enrolled. 15 treatment naïve     patients and 15 treatment experienced patients enrolled   "
221646|NCT00752050|"     The overall purpose of this study is to evaluate the safety and effectiveness of repeat     treatment of an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines,     compared with placebo.   "
221647|NCT00752063|"     HCC is an aggressive, largely chemo-resistant cancer with a poor prognosis, currently there     is no effective systemic chemotherapy for HCC. Epidermal growth factor receptor (EGFR) and     vascular endothelial growth factor (VEGF) are both overexpressed in HCC and thought to     contribute to tumor development. Oxaliplatin in combination with other chemotherapies or     biologic agents have been shown to be an effective and safe treatment in advanced HCC     patients.      Sorafenib, an oral multi-kinase inhibitor, blocks tumor cell proliferation by targeting     multiple growth factor pathways and also exerts an anti-angiogenic effect. Clinically, single     agent Sorafenib has been shown to have some efficacy in patients with advanced HCC and the     primary result of prolonged overall survival seems to have been achieved in the phase III     trial.   "
221648|NCT00752076|"     1. Detection EGFR mutation of cancer cells from malignant pleural effusion. 2. Established     the cancer cell lines with without EGFR mutation from malignant pleural effusion.   "
221649|NCT00752089|"     The purpose of this study is to determine whether an experimental fluoridated dentifrice is     effective in the treatment of dental caries   "
221667|NCT00752323|"     RATIONALE: Imaging procedures that use aminolevulinic acid may help find and diagnose     residual tumor in patients with grade IV malignant astrocytoma who are undergoing surgery to     remove the tumor.      PURPOSE: Our primary long-term goal is to improve the completeness of surgical resection of     malignant brain tumor through image- guided fluorescence localization. We hypothesize that     the use of qualitative fluorescence imaging and point PpIX concentration quantification will     enable more complete tumor resection than normal direct (i.e., white light) visualization,     and thereby improve patient survival.   "
221780|NCT00753831|"     To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery     in ptosis   "
221650|NCT00752102|"     Patients with chronic kidney disease (CKD) have a higher mortality rate than the general     population, with cardiovascular disease (CVD) accounting for approximately 50% of deaths.     Vascular calcification is a common finding in patients with CKD. Furthermore, patients with     CKD develop secondary hyperparathyroidism, partly because of a decrease of calcitriol     synthesis on the kidney. Treatment of secondary hyperparathyroidism includes use of activated     vitamin D including calcitriol and paricalcitol. Recent evidence in dialysis patients suggest     an improved survival in patients using paricalcitol compared to calcitriol.      Studies in uremic rats suggests that there are differential effects of calcitriol and     paricalcitol in expression of markers of soft-tissue calcification independent of     calcium-phosphorus product. Calcitriol increased calcification of vascular smooth muscle     cells cultured in calcification media. There was also significant increase in pulse pressure     in animals treated with calcitriol.      The investigators hypothesize that these different forms of vitamin D may have differential     effects in vascular calcification progression in CKD patients.   "
221651|NCT00752115|"     A comparison of combination chemotherapy of sildenafil plus carboplatin and weekly taxol with     carboplatin and weekly taxol in patients with previously untreated advanced non-small cell     lung cancer. The study hypothesis is that sildenafil may improve the distribution and     efficacy of cytotoxic anticancer agents.   "
221652|NCT00752128|"     The primary objective of the RESOLUTE international registry is to document the safety and     overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a     'real-world' patient population requiring stent implantation.   "
221653|NCT00752141|"     The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets     and oxybutynin gel.   "
221654|NCT00752154|"     Curcuma longa or turmeric is a tropical plant native to south and southeast tropical Asia.     Perhaps the most active component in turmeric is curcumin which may make up 2-5% of the total     spice in turmeric. The study drug being tested in this study is curcumin.      This study is called a cross-over study because all subjects will receive the study drug for     a certain amount of time and then switch to placebo (an inactive substance) for a certain     time or vice versa. The subject's participation may last up to 8 months.      The subject will be randomized (by chance; like flipping a coin) to receive either the study     drug, curcumin, or placebo for 4 months. After 4 months, if the subject was taking curcumin     they will stop taking it and begin to take placebo and if the subject was taking placebo they     will stop taking it and begin taking curcumin for the remaining 4 months. By completion of     the study, all 40 subjects will have taken curcumin and placebo for 4 months each.      Curcumin/placebo will be provided in capsule form and the subject will take it by mouth. The     dose dose will be increased every week for up to a total of 4 grams per day.      Subjects will have blood tests, complete questionnaires, and be seen by the study doctor.   "
221655|NCT00752167|"     We hypothesize that exercise-induced bronchospasm (EIB) at the NCAA Division I collegiate     level is over diagnosed, while poorly controlled asthma resulting in exercise-related     symptoms in this same population may be under diagnosed, being erroneously attributed to EIB.     This project will test individuals self-identified as having exercise induced bronchospasm or     asthma, as well as gender-matched controls from the same sport, with eucapnic voluntary     hyperventilation to assess for the presence of EIB or asthma. By making the correct     diagnosis, improved health outcomes may be achieved and athletic performance may be enhanced.   "
221656|NCT00752180|"     The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard     to its total and to its maximum serum insulin concentrations.   "
221657|NCT00752193|"     The purpose of this study is to assess the safety and the efficacy of vaginally administered     probiotic lactobacilli in combination with antibiotic therapy (metronidazole) in women with     microbiologically defined bacterial vaginosis.   "
221658|NCT00752206|"     The purpose of this study is to determine how long patients who undergo complete surgical     removal of recurrent osteosarcoma in the lung will remain free of cancer after taking     Saracatinib compared to patients taking placebo (a sugar pill).   "
221659|NCT00752219|"     The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the     treatment of complicated intra-abdominal infections as compared to a comparator group.   "
221660|NCT00752232|"     The study is to evaluate the safety, tolerability and whether there is an immune system     response to multiple doses of ACC-001 with or without the use of a substance that may     increase the response to the drug.   "
221661|NCT00752245|"     Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order     to optimize the dialysis dose: patients with sepsis/multi-organ failure. The sampling of     blood and dialysate will be done during dialyses with different durations (4, 6 and 8h)   "
221662|NCT00752258|"     The overall purpose of this study is to evaluate the long-term safety of repeat treatment     with an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines.   "
221663|NCT00752271|"     The purpose of this study is to examine the relationship between muscle activation and heart     rate on joint generalized inflammation and arthritis development.   "
221664|NCT00752284|"     The purpose of this study is to compare the surgical complications and neurosensory     disturbance of coronectomy and conventional excision of wisdom teeth with roots in close     proximity to inferior alveolar nerve. Hypothesis: Coronectomy of wisdom tooth can reduce the     chance of injury to the inferior alveolar nerve in cases of radiographic proximity to the     roots when compared with conventional method of surgical removal of wisdom teeth, and there     is no difference in other surgical morbidities.   "
221665|NCT00752297|"     The overall purpose of this study is to evaluate the safety and effectiveness of an     intramuscular dose of Mentor Purified Toxin for the reduction of frown lines, compared with     placebo.   "
221666|NCT00752310|"     The purpose of this study is to evaluate in healthy volunteers how much and how fast the new     suspension compared to the commercial darunavir tablet, given in combination with low-dose     ritonavir, are absorbed into the body (called the relative oral bioavailability).   "
221719|NCT00752999|"     Approximately 225 patients meeting study entry requirements will be enrolled and randomized     (2:1, active versus placebo superimposed on background treatment) to R788 or placebo.     Patients will be followed for efficacy and safety parameters for 6 months. The investigator     should taper corticosteroids if clinically warranted.   "
221668|NCT00752336|"     A prospective, interventional rehabilitation program was initiated to improve exercise     tolerance and psychosocial functioning in patients after heart transplantation (HTx) and to     evaluate long-term effects on health-related quality of life (HRQoL).Study subjects were     randomized to either intervention or to control group and were followed with regular     cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after HTx.     Patient characteristics did not differ concerning age, gender, and diagnosis at study entry.     IG patients received regular psychosocial support and performed a home-based supervised     ergometer training program. CG patients were recommended to perform regular exercising.   "
221669|NCT00752349|"     Ultrasound is widely applied in many fields of medicine but less commonly used in the     evaluation of tongue movement and swallowing abnormality. Fuhrman RAW reported the usefulness     of using ultrasound to evaluate poor tongue coordination [1]. Peng CL stated that ultrasound     could provide excellent quantitative and qualitative bases of tongue movement during     swallowing using cushion-scan technique [2]. Videofluoroscopic swallowing study (VFSS) is     widely accepted as the gold standard of evaluating swallowing abnormality because it is able     to evaluate the whole swallowing procedure without interference of pharyngeal contraction and     foreign body sensation when swallowing is examined by using a fiber-optic laryngoscope. One     of the most important information that VFSS can provide is the detection of subclinical     silent aspiration. The decision and management of many patients with swallowing abnormalities     are usually based on the VFSS findings [3]. As shown in many reports, our experiences showed     that VFSS provided extremely important information of understanding the pathophysiologic     change of dysphagia due to variable etiologies, such as in patients with nasopharyngeal     cancer suffering from radiation therapy [4] and in patients with stroke [5]. Using the     findings of VFSS, physicians and medical staffs can make important decision whether oral     feeding should be given, which safety swallowing maneuver works and what is the appropriate     choices of food consistency safe to dysphagic patients. The difficulties of VFSS are usually     in the transportation of paraplegic and hemiplegic patients from ward to the examining chair.     The frequency and examination duration of VFSS is usually limited for avoiding unnecessary     radiation exposure. Hence, ultrasound provides a role in evaluating oral condition with the     benefits of convenience of transportation and availability as well as no radiation exposure.     Therefore, validation of the value of ultrasound for the oral swallowing with correlation of     VFSS is important to test the clinical feasibility.      Peng CL et al reported their experiences of using real-time ultrasound in the evaluation of     intrinsic tongue movement [2, 6, 7]. The findings of submental ultrasound are quite different     from the findings of VFSS which provides the surface information of the tongue in the     swallowing of radiopaque barium sulfate bolus. Combined real-time B mode and M mode     ultrasound, it was reported the potential of digital data analysis of oral phase swallowing.     Kuhl V et al reported the usefulness of ultrasound in the evaluation of laryngeal elevation     in patients with dysphagia [8]. They found significant decrease of laryngeal elevation in     patients diagnosed as neurogenic dysphasia [8]. Casas et al successfully combined ultrasound     examination and plethysmography to evaluate the swallowing condition of children with     cerebral palsy [9]. The results of these studies explained the potential of ultrasound in     oral swallowing and dynamic laryngeal movement.      Our experiences of VFSS showed the usefulness VFSS in diagnosing and management of patients     with swallowing problem or dysphagia [4, 5, 10, 11]. To our knowledge, there was little     experience of comparing between ultrasound and VFSS in patients with swallowing problem.     Therefore, we conducted this study to correlate submental ultrasound and VFSS findings and     tried to find out the clinical feasibility and usefulness.      Purposes: This study was to evaluate the usefulness of submental ultrasound (SM US) in oral     phase swallowing in correlation with videofluoroscopic study (VFSS).        1. To compare normal volunteers and patients with swallowing abnormality with submental          ultrasound.        2. To evaluate and compare patients with swallowing problem using submental ultrasound and          VFSS.      Type of study: Retrospective. Time of study: Jan 2004 - July 2006.   "
221670|NCT00752362|"     Objectives:      PRIMARY OBJECTIVE:      To compare the in-stent late loss at 9 months of paclitaxel- and sirolimus- eluting stents     with the late loss of bare metal control stents.      SECONDARY OBJECTIVES:      Safety:      To compare the occurrence of Major Adverse Cardiac Events (MACE) at 30 days, 9 months, 1     year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.      To compare the occurrence de Serious Adverse Events (SAEs) within 5 years among the     paclitaxel, sirolimus and control study arms.      To compare the occurrence of in-stent thrombosis within 5 years among the paclitaxel,     sirolimus and control study arms.      Efficacy:      To compare the rate of angiographic success among the study groups To compare the rate of     procedural success among the study groups To compare the incidence of clinically driven     target lesion revascularization at 9 months, 1 year, 3 years and 5 years among the     paclitaxel, sirolimus and control study arms.      To compare the incidence of clinically driven target vessel revascularization at 9 months, 1     year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.      To compare the 1-year, 3-year and 5-year cost-effectiveness profile of the paclitaxel,     sirolimus and control study arms.      To compare the 9-month in-stent late loss of paclitaxel-eluting stents to the in-stent late     loss of sirolimus-eluting stents To compare the 9-month in-segment late loss among the study     groups To compare the 9-month in-stent and in-segment binary restenosis rate among the study     groups To compare the IVUS percent neointimal obstruction among the study groups      Study Design:      In the present RANDOMIZED study, the paclitaxel-eluting stent Infinnium® and the     sirolimus-eluting stent Supralimus® will be compared to a metallic stent with the same     structure (Milennium Matrix®) but without drug elution for the treatment of de novo lesions     in native coronaries. The study will be a multicenter clinical trial and will include     patients for the treatment with one of the three study stents. In total, 275 patients will be     enrolled, randomly allocated for the Infinnium®, Supralimus®, or Milennium Matrix® stents in     a 2:2:1 proportion. Patients will be followed-up for 12 months after the index procedure. All     patients will undergo a follow-up angiography at 9 months. A subgroup of 55 patients will be     evaluated at 9 months with IVUS examination.      Treatment:      Patients will be treated, according to the randomization groups, with Infinnium®,     Supralimus®, or Milennium Matrix® stents of 19 mm, 23 mm, or 29 mm and nominal diameters of     2.5, 3.0, and 3.5 mm.   "
221671|NCT00752375|"     Children who present with pyelonephritis undergo many investigations, and long term care to     prevent renal damage. The focus is primarily on preventing renal failure however along the     way and particularly with children, other issues arise which impact their lives, as well as     their family's lives. Parents are concerned about subjecting their children to invasive     procedures and long term antibiotic use, particularly if they are not sure of the benefit.     This study seeks to provide information on the impact of investigation and long term     antibiotic treatment in reference to long term health and quality of life in children who     present with febrile urinary tract infections in the absence of anatomic abnormalities.   "
221672|NCT00752388|"     To assess the predictive value of sequential administration of WHO-5 and MDI (Major     Depression Inventory) for the clinical management of Parkinson Disease (PD) patients by        -  determination of the prevalence of depression in PD patients, based on MDI severity          categories and the self-rating scale WHO-5, where poor well being was indicated.        -  exploration of influencing factors (PD status, therapeutic status) on the prevalence of          MDI depression categories.   "
221673|NCT00752401|"     The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3)     substitution on the posttransplant outcome (glomerular filtration rate as well as serum     creatinine levels, number of acute rejection episodes, number of infections and C-reactive     protein levels within the first year after transplantation) in vitamin D deficient kidney     transplant recipients.   "
221674|NCT00752414|"     Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent     acute exacerbations (AECB) which are associated with enormous healthcare expenditures and     significant morbidity, specifically an increased risk of death, a decline in pulmonary     function and a significant change in quality of life. Bacteria appear to have an important     role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in     COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In     addition, recent studies indicate that acquisition of a new strain of H. influenzae, M.     catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations.     Chronic inflammation and bacterial infection predispose many patients to frequent and     recurrent acute exacerbations.      Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will     decrease the incidence of acute exacerbations by both by lowering the organism burden, and     resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial     strains.   "
221675|NCT00752427|"     The purpose of this open-label study was to evaluate the safety and tolerability of flexible     doses of Extended Release OROS® Paliperidone in the treatment of geriatric subjects with     schizophrenia after completion of the initial double blind study   "
221676|NCT00752440|"     This study describes a controlled randomized clinical trial to evaluate the effect of     inspiratory muscle training in patients with diabetic autonomic neuropathy.   "
221677|NCT00752453|"     Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order     to optimize the dialysis dose: patients with lactate acidosis. The sampling of blood and     dialysate will be done during dialysis with different durations (4, 6 and 8 h)   "
221678|NCT00752466|"     The primary purpose of this open-label study is to determine if concomitant therapy with     topiramate and flunarizine has any effect on the pharmacokinetics of either drug. Safety will     be assessed for all subjects, for the entire duration of the study.   "
221679|NCT00752479|"     This a pilot, explorative study to define the safety and biological/mechanistic effect of the     systemic intravenous infusion of syngeneic ex-vivo expanded MSCs in living-related kidney     transplant recipients (one or two HLA haplotype mismatches) under basiliximab/low-dose RATG     induction therapy and maintenance immunosuppressive drugs with the ultimate objective to test     the feasibility of safely achieving graft tolerance in a subsequent efficacy pilot study.      Specific objectives To compare changes in the immunophenotype and ex-vivo T-cell functional     tests from samples of peripheral blood and measurement in the urine of messenger RNA for     FoxP3,in kidney transplant recipients given or not syngeneic (from the recipient) MSC     infusion under basiliximab/low-dose RATG induction therapy and maintenance immunosuppressive     treatment with low-dose cyclosporine (CsA) plus low-dose mycophenolate mofetil (MMF).      This will assess at different time up to 12 months post transplant. In addition the safety     profile of MSC infusion will be investigated. We have planned to start with the safety and     biological/mechanistic study in 6 living-related kidney transplant recipients. Three patients     will receive ex-vivo expanded syngeneic MSC infusion (2x106 MSCs per kilogram body weight) at     the time of kidney transplant, and 3 additional patients no cells (controls), both under the     cover of induction therapy with basiliximab and low-dose RATG, and maintenance     immunosuppression with low-dose CsA and MMF. Randomization to MSC or no cell infusion will be     performed at the time the recipient will sign the informed consent to participate to the     study.      Should this biological/mechanistic ex vivo studies document that MSC infusion allows the     development of an immune microenvironment permissive to graft tolerance, a pilot efficacy     study to achieve operational tolerance after complete withdrawal of maintenance     immunosuppressive therapy will follow.      In this additional pilot explorative efficacy study all consecutive patients will be included     and followed until the first episode of rejection (if any) will occur or 29 consecutive     patients have successfully withdrawn the immunosuppressive therapy. This has been estimated     according to the Simon's two-stage minimax design.   "
221680|NCT00752492|"     Faster recovery from anesthesia is important for obese patients because they are at high risk     of respiratory complications following tracheal extubation. Isoflurane has several properties     that make it a preferable agent for anesthesia in obese patients. Its main limitation is a     longer recovery time due to slower elimination in comparison to other agents. Elimination of     isoflurane from the lungs can be accelerated by increasing in patient's minute ventilation,     which decreases the level of CO2 in blood (hypocapnia).Isocapnic Hyperpnoea (IH) is a method     allowing increased ventilation and therefore enhancement of the elimination of inhalation     agents while maintaining a normal blood CO2 level. The investigators will compare recovery     time from isoflurane anesthesia in obese patients during standard anesthesia management     protocol (control) to a group treated with IH.   "
221681|NCT00752505|"     The study is designed to assess if esreboxetine can improve the cognitive function of     patients with fibromyalgia. Cognitive function is defined as the ability to concentrate,     remember things and make decisions or problem solve. The study is also designed to assess if     there is a difference in cognitive function between fibromyalgia patients and matched control     subjects.   "
221682|NCT00752518|"     The purpose of this study is to assess the safety/tolerability and determine the Japanese     recommended dose (RD) of bortezomib administered as a once-daily intravenous bolus twice     weekly for 2 consecutive weeks(Days 1, 4, 8, and 11) followed by a 10-day rest period (Days     12 to 21) in Japanese patients with relapsed or refractory multiple myeloma.   "
221723|NCT00753051|"     Clozapine treatment resistant schizophrenia is still prevalent.The effectiveness of     augmenting clozapine : one augmenting with haloperidol and the other with electroconvulsive     therapy should be determined.This study is a randomized control trial.   "
221683|NCT00752531|"     All chronic obstructive pulmonary diseases (COPDs) block air flow to the lungs, and the two     most common forms, emphysema and chronic bronchitis, are the most common causes of     respiratory failure. Previous research shows that if COPD patients know more about their     disease and how to manage it themselves, they will improve their quality of life and reduce     their need for urgent care. However, traditional methods of teaching COPD patients about     their disease and self-management skills are expensive and require intensive work. A new,     less expensive way of reaching a large group of people with this information is needed to     help patients stay healthier and happier with their treatment. This study will create a     computer program that can help people learn about their disease and how to manage it     themselves. This study will then determine whether the computer program, called Home     Automated Telemanagement (HAT), helps patients with COPD in managing their disease and     following their treatment plans.   "
221684|NCT00752544|"     The purpose of this study is to evaluate the safety and tolerability of three different doses     of TMC435350 compared to placebo in healthy Japanese males.   "
221685|NCT00752557|"     The main purpose of this study is to assess whether a locally-administered rhBMP-2/CPM     injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures     of the hip. All subjects will receive standard treatment for low bone mass, consisting of     bisphosphonates, calcium, and vitamin D (all taken by mouth). Subjects that are randomly     selected to receive treatment with rhBMP-2 will receive an injection directly into the hip.     The injection is given in a surgery room using a light anesthesia.   "
221686|NCT00752570|"     This clinical trial will compare the efficacy and safety of the combination of AMG 386 and     FOLFIRI with FOLFIRI alone in second line treatment of metastatic colorectal cancer.   "
221687|NCT00752583|"     Study in order to quantify toxin removal during dialysis   "
221688|NCT00752596|"     This is an open-label, long term compassionate use study of 125 mg per day of azimilide 2HCl     in a patient who completed two other protocols (2000098 and 2001060.   "
221689|NCT00752609|"     The purpose of this study is to determine the efficacy and safety of Peginesatide Injection     for the maintenance of anemia in patients with chronic renal failure who are on hemodialysis     or do not require dialysis and who were previously treated with Darbepoetin Alfa.   "
221690|NCT00752622|"     This is an open-label, interventional study where a subset of participants will be randomized     to one of two treatment-optimization strategies. Participants with moderate to severe Crohn's     disease (CD) will receive induction treatment comprised of 3 infusions of infliximab at Weeks     0, 2, and 6. The participants will be evaluated at Week 10. Participants who are in clinical     response will enter the observational phase of the study where they will receive standard of     care treatment, as per the infliximab product monograph. Participants who lose response, may     qualify for entry into the interventional phase of the study, where they will be randomized     to one of the following treatment-optimization arms: 1) dose increase: infliximab 7 mg/kg,     every 8 weeks or 2) shortened interval: infliximab 5 mg/kg every 6 weeks.      Note: Due to early study termination, no statistical analysis was performed for the     interventional part of this study, therefore, endpoints dedicated to this phase of the study     have not been analyzed.   "
221691|NCT00752635|"     The purpose of this study was to evaluate the effectiveness and safety of     norgestimate-ethinyl estradiol as comparted with cyproterone acetate-ethinyl estradiol among     female patients with moderate acne vulgaris.   "
221692|NCT00752648|"     The objectives are: to compare the oral bioavailability and plasma pharmacokinetics of     TMC435350 for 2 different solid formulations to those of TMC435350 formulated as a powder     blend in a capsule, after a single oral dose of 200 mg in healthy volunteers; to determine     the short term safety and tolerability of TMC435350 after a single oral dose of 200 mg     formulated in capsules with 2 different formulations and as a tablet in healthy volunteers   "
221693|NCT00752661|"     The purpose of this study is to find the clinical dose range of an active ingredient of     JNS013 - Tramadol hydrochloride in chronic-pain patients who cannot attain a sufficient     analgesic effect from non-steroidal anti-inflammatory drugs (NSAIDs).   "
221735|NCT00753207|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving lapatinib together with epirubicin may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of epirubicin when     given together with lapatinib in treating patients with metastatic breast cancer.   "
221775|NCT00753766|"     The purpose of this study is to advance the quality of care among inpatients with diabetes in     the VHA. When patients with diabetes are admitted to the hospital, there is a greater chance     that they will have a complication that lengthens their stay in the hospital. We are testing     whether managing their diabetes before admission makes a difference in occurrence of     in-hospital complications.   "
221694|NCT00752674|"     The research was an interventional study with a quantitative board, fulfilled in a private     clinique specialized in trauma service; it was formed between august to October of 2006. The     objective was to investigate the effectiveness of neuromuscular balance in lumbar pain. The     12 patients, with age between 20 and 55 years, whose did five consultations, with 100%     presence, got relief of the pain and increase of movement of hips' articulation which was the     most painful movement with 91,66% graduation. All the patients presented the shorting test     positive and it kept positive in 7 patients. There was a significant improvement in pain     relief (p=0,001,) comparing the first and the fifth consultation, and hip articulation     movement. Even after the relief of the pain, 7(58,3%) of the patients kept the treatment for     a more effective rehabilitation and prevention of repetition of the symptoms. It was     concluded that the neuromuscular balance relieved quickly the pain, being essential for     effective rehabilitation of low back pain, with the inclusion of others manual techniques.   "
221695|NCT00752687|"     To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers     and its anti-viral activity in HCV infected subjects.   "
221741|NCT00753285|"     The purpose of this study is to investigate the clinical utility of renal denervation for the     treatment of refractory hypertension.   "
227856|NCT00828542|"     The purpose of this study to assess the safety of the etonogestrel-releasing subdermal     implant (Implanon) inserted during the immediate puerperium of healthy women.   "
221696|NCT00752700|"     The first part of the study is an observational part. In eligible patients with early stage     respiratory cancer, the primary and secondary endpoints will be evaluated before and after     their scheduled radical cancer therapy. The measured variables, include a blood sample,     pulmonary function tests, level of dyspnea, exercise tests, measurement of body composition,     respiratory and peripheral muscle force, health related quality of life and psychological     status. Only registered participants having completed a radical treatment and having either     less than 70% of the predicted normal value of the quadriceps force (QF) or a decrease of     more than 10% predicted value of the QF between pre-and post radical treatment, will be     allowed to participate to the second part of the study. These patients will then be     randomized in three groups. Group A, the control group, will have the usual care and follow     up according to clinical symptoms. Group B will be offered a conventional resistance training     program (CRT), and group C, will be offered a whole body vibration resistance training (WBV)     on the FITVIBE-platform. All previous variables will be measured after 6 and 12 weeks of     training.   "
221697|NCT00752713|"     The aim of the study was therefore to evaluate whether myocardial deformation imaging     performed by SENC allows for quantification of regional left ventricular function and is     related to transmurality states of infarcted tissue in patients with acute myocardial     infarction (AMI).   "
221698|NCT00752726|"     The purpose of this study is to determine if a 24 week weight loss program with orlistat 60     mg will produce greater changes in body composition compared to placebo.   "
221699|NCT00752739|"     RATIONALE: Selenium may prevent or slow the growth of prostate cancer.      PURPOSE: This randomized phase II trial is studying how well selenium works in treating     patients with prostate cancer.   "
221700|NCT00752752|"     Using blood testing and cardiac magnetic resonance imaging (MRI), the investigators aim to     determine if there are necrotic areas of myocardium in participants who complete a marathon.     In addition, the investigators aim to describe the acute and chronic structural abnormalities     that occur as a result of endurance training. The study hypothesis is that myocardial     necrosis is present in runners completing a marathon competition.   "
221701|NCT00752765|"     This project is a prospective observational study that will involve the participation of 25     volunteers that qualify for having knee osteoarthritis, are going to be having gastric bypass     surgery and are willing to participate in this study which is designed to last up to two     years. Potential candidates will be interviewed using a standard set of questions related to     the study   "
221702|NCT00752778|"     To evaluate the diagnosis value of MRI and positon emission tomography (PET) scan for     studying macrophagic infiltration and other brain modification in multiple sclerosis (MS)     patients treated with Natalizumab (Tysabri).   "
221703|NCT00752791|"     The purpose of this study is to determine the efficacy and safety of peginesatide injection     for maintenance treatment of anemia in participants on peritoneal dialysis.   "
221704|NCT00752804|"     Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order     to optimize the dialysis dose: patients after cardiac surgery.The sampling of blood and     dialysate will be done during dialyses with different durations (4, 6 and 8h)   "
221705|NCT00752817|"     Laparoscopic Colectomy is an advanced minimally invasive procedure that requires advanced     laparoscopic skills.      Minimally invasive surgery offers many advantages to the patients but exposes the surgeon to     new challenges, many of which are human factor in nature. This in turn prolongs the learning     curve and has delayed the widespread adoption of minimally invasive surgical techniques in     the management of patients with colorectal disease.      Virtual reality simulation offers an effective way of training whereby surgical trainees can     train repeatedly and achieve proficiency in a shorter time and a safe environment.   "
221706|NCT00752830|"     The purpose of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328     in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule)     during two treatment periods, after food intake or during fasting condition.   "
221707|NCT00752843|"     This study is to determine the effect of single and multiple oral doses of mifepristone on     the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.   "
221736|NCT00753220|"     The purpose of this study is to determine if the intra-tumoral injection of a subject's own     dendritic cells after cryotherapy of the prostate is a safe and effective treatment for     advanced prostate cancer.      In theory, the injected dendritic cells will internalize antigens from the tumor cells which     have been damaged by cryotherapy and activate the subject's immune system against that     specific tumor.      Subjects will also receive a low dose chemotherapy designed to lower the number of     T-regulatory cells which have been shown to lower or stop some immune system responses.      Hypothesis 1: Dendritic cell injection into cryotreated prostate cancer is non-toxic;      Hypothesis 2: Dendritic cell injection into cryotreated prostate cancer is medically     beneficial to the subject.   "
221776|NCT00753779|"     The primary objective is to determine the effect of WelChol tablets on serum lipids,     lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized     on simvastatin therapy for at least 4 weeks.   "
221720|NCT00753012|"     The purpose of this research study is to learn about the effects of a medication called     Vyvanse on the heart (cardiovascular system). The U.S. Food and Drug Administration (FDA) has     approved Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). People     who have ADHD have trouble paying attention, organizing, and planning; these symptoms can     cause problems at work, socially and at home.      Vyvanse (also known as Lisdexamfetamine) is a stimulant class medication. There have been     reports of serious cardiovascular effects in children and adults treated with stimulants.     While there is no definite evidence that these events were related to the use of stimulants,     the deaths have raised questions about the cardiovascular safety of stimulants.      The study will involve in-depth cardiovascular tests, namely echocardiograph (ultrasound of     the heart) and cardiopulmonary exercise test (also called stress test; subjects exercise on a     bicycle while measuring their heart activity and breathing is monitored by cardiologists).      The investigators predict to see changes in blood pressure and heart rate as shown in     previous clinical studies, and that the in-depth cardiovascular tests will provide new     insights into the cardiovascular impact of stimulants.   "
221708|NCT00752856|"     CCTG 589 is a randomized, open-label, pilot study comparing the efficacy, safety and     tolerability of RAL plus LPV/r to EFV plus TDF/FTC in HIV-infected, treatment-naïve subjects.     Subjects will be ineligible if they have any evidence of drug resistant virus in the past or     at the time of screening (if never previously tested). Those who are found to be eligible     will be randomized 1:1 to initiate either LPV/r (400/100 mg) plus RAL (400mg), both given     twice-daily, or fixed dose combination of EFV (600 mg), TDF (300 mg) and FTC (200 mg) given     as once-daily Atripla® for 48 weeks.      Hypotheses        1. The novel nucleoside-sparing combination of LPV/r + RAL will have a faster phase 1 viral          decay rate compared to standard-of-care therapy with EFV/TDF/FTC in antiretroviral-naïve          patients.             1. Faster phase 1 viral decay dynamics will be associated with improved longer-term               (week 48) viral suppression.             2. Faster phase 1 viral decay dynamics will be associated with accelerated early (Day               0-14) clearance of cell-associated HIV DNA.             3. Faster phase 1 viral decay dynamics will be associated with greater early (baseline               to week 12) CD4+ T-cell recovery.        2. The LPV/r + RAL arm will have greater decreases in early (baseline to week 4) CD4/CD8          T-cell immune activation and apoptosis which will be associated with greater late (week          12 to week 48) CD4+ T-cell recovery.        3. Subjects treated with LPV/r + RAL arm will have smaller changes in total cholesterol and          triglycerides from baseline than those receiving EFV/TDF/FTC.   "
221709|NCT00752869|"     This is a study using two FDA approved medications: Testosterone and the study medication,     Dutasteride (Avodart 0.5mg/day). Half of the subjects will receive dutasteride and half will     receive a placebo. The study medication will be taken for 12 months.      The subjects participating in the study are men who are already taking their own testosterone     supplement because they have low testosterone levels which may cause them to experience     sexual function difficulties, have fatigue or other symptoms. Testosterone can have an     adverse effect of causing an enlarged prostate (Benign Prostatic Hypertrophy) (BPH).      Dutasteride (Avodart) is an approved medication used to decrease the prostate size, prevent     urinary symptoms and reduce the risk of surgery.      The researchers would like to see if by taking dutasteride and testosterone at the same time     they can prevent the adverse effects of testosterone and at the same time get the positive     benefits of testosterone.      There will be 6 scheduled visits for the study and 2 diagnostic tests called a TRUS     (TransRectal UltraSound), to evaluate prostate size. The six visits at will include     consenting, blood work, two sexual function questionnaires, a physical examination, physical     measurements, study medication teaching and dispensing of study medication.   "
221710|NCT00752882|"     Meningitis is an infection where morbidity and mortality depend on the delay of the initial     treatment for a good prognostic. The antibiotherapy rapidity allows to decrease the     mortality. Intermittent administration of ceftazidime is a reference treatment of Pseudomonas     aeruginosa meningitis. In the case of Pseudomonas aeruginosa pneumopathy, ceftazidime can be     administered by intermittent injections or by continuous perfusion. The continuous     administration of ceftazidime is not validated in Pseudomonas aeruginosa meningitis. However,     ceftazidime is a time dependant antibiotic and continuous treatment would provide a more     efficient therapeutic. The aim of this study is to determine if the continuous administration     of ceftazidime could permit a better therapeutic practice of Pseudomonas aeruginosa     meningitis compared with intermittent administrations.   "
221711|NCT00752895|"     RATIONALE: American ginseng extract may prevent or reduce acute respiratory illness in     patients with chronic lymphocytic leukemia. It is not yet known whether American ginseng     extract is more effective than a placebo in preventing respiratory infections.      PURPOSE: This randomized trial is studying the side effects of American ginseng extract and     to see how well it works compared with a placebo in preventing respiratory infection and in     reducing antibiotic use in patients with chronic lymphocytic leukemia.   "
221712|NCT00752908|"     The purpose of this study is to evaluate cefoxitin pharmacokinetics in obese surgical     patients.   "
221713|NCT00752921|"     Headache during fasting is a known entity in the scientific literature. The prevalence of     such a headache is high and in a study conducted in Israel was found in 60% of people with a     previous predilection for headache. A prior study showed a significant decrease in the     incidence of fasting headache using rofecoxib, but the drug has been taken off the market.     The goal of this project is to evaluate the efficacy of etoricoxib as treatment taken before     the fast- a COX-2 inhibitor with a relatively long half life to prevent fasting induced     headache. The study will be a prospective double blind placebo controlled trial using adult     volunteers with a history of a fasting headache who will be abstaining from food and drink on     Yom Kippur.      The study hypothesis is that treatment with etoricoxib prior to a 25 hour fast will decrease     the incidence of fasting headache.   "
221714|NCT00752934|"     Baclofen is a drug that reduces the muscle stiffness. In disabled children that have very     stiff muscles, the stiffness and secondary changes in the joints may cause discomfort and     pain. In this study we will check if treatment with Baclofen reduces pain in disabled     children with stiff muscles.   "
221715|NCT00752947|"     The purpose of this study is to determine whether moxifloxacin in comparison to levofloxacin     plus metronidazole are effective and safe in the treatment of community-acquired pneumonia     with aspiration factors.   "
221716|NCT00752960|"     The purpose of this study is to assess patients treated with the antipsychotics aripiprazole     (Abilify®), olanzapine (Zyprexa®), quetiapine (Seroquel®), risperidone (Risperdal®), or     ziprasidone (Geodon®) and to identify genetic variations more commonly found in individuals     who develop diabetic metabolic signs and symptoms, which include changes in blood lipids,     blood glucose, blood pressure, and body weight.   "
221717|NCT00752973|"     In a previous phase II study, the safety and efficacy of a novel formulation of malathion     0.5% was evaluated in patients 2 years of age and older. Based on the results of that study,     this formulation is currently in a phase III study for that population.      The current study will use blood markers and clinical evaluations to determine the safety and     tolerability of this formulation when used in children 6-24 months of age.   "
221718|NCT00752986|"     The primary objective is to assess the event-free survival defined as the time from     randomisation to progression, death without progression, loss to follow up, whichever     occurred first..   "
224793|NCT00787917|"     This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic     Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and     older.   "
221724|NCT00753064|"     The data available for the efficacy of AScVS and prazosin is generated through different     trials done in different clinical setting. Hence it was felt worthwhile to confirm the     documented efficacy of AScVS and prazosin in terms of time taken for clinical recovery in a     clinical trial. Along with this, effects of both the therapies on various biochemical     parameters will be recorded and compared with. It was also felt necessary to study the effect     of combination on the clinical outcome.   "
221725|NCT00753077|"     Oral appliances, which can maintain patients' jaw forwards during sleep, become more popular     in treating obstructive sleep apnea (OSA). However, the exact mechanism of mandible forward     on upper airway is not completely known. In this study we will use both static and dynamic     MRI to study the 3D morphological changes and dynamic behavior of the upper respiratory tract     at different mandible posits. Because in asian society non-obese OSA patients are not     uncommonly seen, in this study we focus only on non-obese severe OSA patients.   "
221726|NCT00753090|"     This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to     evaluate the clinical efficacy of the DDRP components.   "
221727|NCT00753103|"     The purpose of this study is to determine whether Infliximab (monoclonal anti-tumour necrosis     factor alpha antibodies) are safe and effective in the treatment of anti-neutrophil cytoplasm     antibody (ANCA) associated vasculitis.   "
221728|NCT00753116|"     The purpose of this this study is to investigate the clinical utility of renal denervation in     the treatment of ESRD patients with refractory hypertension.   "
221729|NCT00753129|"     Semi-recumbent position leads to improvement of gas exchange and lung mechanics in patients     suffering from ALI or ARDS. Prone positioning leads to similar effects. To date, no data on     the combination of these two positioning measures exist. The investigators hypothesize that     head elevation in prone position leads to improvement in gas exchange and lung mechanics.   "
221730|NCT00753142|"     Obesity is common in African-American patients with newly diagnosed diabetes who present with     diabetic ketoacidosis (DKA).1 Despite the presentation with severe symptoms of insulinopenia     and ketoacidosis, clinical and immunogenetic observations indicate that most obese AA     patients with DKA have type 2 diabetes. In such patients, our previous studies reveal: a) at     presentation, obese AA patients with DKA have markedly de-creased pancreatic insulin     secretion, lower than in obese non-DKA patients admitted with comparable hyperglycemia, but     significantly greater than in lean patients with DKA;2 b) aggressive diabetic management     results in significant improvement in b-cell function and insulin sensitivity sufficient to     allow discontinuation of insulin therapy within 3 months of follow-up.2, 3 Based on these     observations we conclude that similar to obese patients with hyperglycemia, most obese AA     with DKA have type 2 diabetes, and that although defects in both insulin secretion and     insulin action are present, transient b-cell failure is the primary defect in the development     of ketoacidosis.   "
221731|NCT00753155|"     A prospective, interventional rehabilitation program was initiated to improve exercise     capacity and psychosocial functioning in patients after lung transplantation (LTx) and to     evaluate long-term effects on health-related quality of life (HRQoL).      Study subjects were randomized to either intervention or to control group and were followed     with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months     after LTx. Patient characteristics did not differ concerning age, gender, and diagnosis at     study entry. IG patients received regular psychosocial support and performed a home-based     supervised ergometer training program. CG patients were recommended to perform regular     exercising.   "
221732|NCT00753168|"     The purpose of this study is to evaluate the safety and potential efficacy of a new drug,     OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of     patients with open angle glaucoma or ocular hypertension. It will be compared with commercial     timolol and placebo eye drops.   "
221733|NCT00753181|"     To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal     Plan including Diabetes-Specific products compared to average daily blood glucose in subjects     following their usual diet.   "
221734|NCT00753194|"     The purpose of this study is to investigate the rate of false-positive results in Newborn     Universal Hearing Screening Programs and it´s possible causes.   "
221749|NCT00753402|"     Epinephrine (adrenaline) is a substance produced by the body (in the adrenal gland) in     response to stress such as infection or injury. Endotoxin is a man- made substance, which     causes the body to mimic sickness (fever, chills, and achiness) for a few hours. This study     is designed to give epinephrine before and/or after endotoxin to determine if this medication     can prevent or relieve any of the symptoms caused by endotoxin.   "
221737|NCT00753233|"     This study will review medical information collected on children and adolescents with     hypertrophic cardiomyopathy (HCM) to try to identify risk factors for arrhythmias (abnormal     heart rhythms) in these patients and better guide the choice of treatment options for them.     Arrhythmias arising from the ventricle (lower heart chamber) can cause dizziness, fainting or     cardiac arrest. Predictors of arrhythmias in adult HCM patients may not apply to children and     teenagers with HCM.      Children and adolescents 21 years of age or younger who were diagnosed with HCM and evaluated     in the National Heart Lung and Blood Institute's Cardiology Branch between 1977 and 2002 may     be eligible for this study.      Participants do not undergo any further testing or data gathering beyond a review of their     medical records; only existing data previously collected for research purposes are used.     Medical records are reviewed for age of the patient on admission to the NIH; family history     of sudden death, fainting, exercise-induced low blood pressure, and results of tests on heart     structure and function.   "
221738|NCT00753246|"     Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma   "
221739|NCT00753259|"     -  Randomized controlled trial comparing specialized AF Clinic with 'care as usual'        -  Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF,          using guideline-based dedicated software, under supervision of a cardiologist, is          efficient, safe and not inferior to care as usual by a cardiologists.   "
221740|NCT00753272|"     The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals'     influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided     in two surveillance phases: one passive phase along the study during the influenza season and     one active surveillance phase during the influenza peak season.   "
221742|NCT00753298|"     The study is designed as a randomized, double-blind, parallel-group, multi centre study     comparing perception and tolerability of investigational product and comparator. In the     randomized part of the study the subjects will be given either LoFric Primo (POBE) or the     comparator LoFric Primo (PVC) for use over 4 weeks. The hypothesis is that subject perception     and satisfaction of POBE is equal to or better than for PVC.   "
221743|NCT00753311|"     Triptans are first choice drugs in the acute treatment of migraine and cluster headache.     However, while in cluster headache the response rate to subcutaneous sumatriptan is 96%,     around 30% of patients fail to respond to a particular triptan. Nonresponse is likely to be     due to a variety of factors, including low and inconsistent absorption, inadequate dosing,     and variability in individual response5. Timing of administration is also a crucial issue. In     fact, an early treatment of the attack, when the pain is still mild, may increase the     responders rate by circumventing the development of cutaneous allodynia (expression of     central sensitization of pain pathway) during the course of the attack.      Several studies have been performed in an attempt to genetically, psychologically and     clinically characterize the triptan responders but failed to provide conclusive results.      Nevertheless, we suggested that the presence of UAs during the migraine attack might predict     a good response to triptans. UAs are common in migraine patients. They have been reported in     almost one out of two migraineurs (45.8%) attending a tertiary headache centre and in more     than one out of four (26.9%) in a population-based study. In an open study with sumatriptan     50 mg performed on 72 migraine patients with UAs, we described pain relief in 65.3% of the     patients at 1 h and in 81.9% at 2 h, while pain-free in 30.6% at 1 h and in 61.1% at 2 h. We     hypothesized a large-scale recruitment of peripheral neurovascular 5-HT1B/1D receptors     consequent to the activation of the trigeminal-autonomic reflex in such patients. Our     hypothesis has received further confirmation by the demonstration of higher levels of     calcitonin gene-related peptide, neurokinin A and vasoactive intestinal peptide (the hallmark     of the activation of the trigeminal autonomic reflex) in external jugular blood in     rizatriptan responders than in non-responders.      The investigators therefore postulate that migraineurs with UAs may respond better to     rizatriptan than general migraine population.      The aim of the study is to evaluate the efficacy of rizatriptan 10 mg lyophilized wafer (MLT)     compared to placebo in the treatment of acute migraine in patients with unilateral autonomic     symptoms (UAs: unilateral lacrimation, eye redness, eyelid oedema, nasal congestion or     rhinorrhoea, miosis or ptosis, forehead or facial sweating) during the migraine attack.   "
221744|NCT00753324|"     The investigators will enroll a cohort of HIV-infected pregnant women accessing PMTCT     services, to better understand the incremental benefits (e.g. reduction in HIV transmission,     improvements in HIV-free survival) and risks (e.g. drug toxicities) of the routine HAART     strategy, in comparison to HIV-infected pregnant women accessing the Zambian Standard of Care     services.      The investigators will test the hypothesis that routine use of HAART produces significant     reductions in HIV transmission rates, with only minimal side effects.   "
221745|NCT00753337|"     The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt     Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of     subjects with Peripheral Artery Disease (PAD).   "
221746|NCT00753350|"     This will be an open label, single-center, feasibility study comprised of two sequential     cohorts( cohort 1: 2 participants; cohort 2: 8 participants).      This study will be conducted in generally healthy participants aged 25 to 55 years with     non-morbid obesity and a pre-screening body mass index between 35 and 40.      Participants will undergo screening to determine their health status and their eligibility to     participate in the study. Eligible patients will undergo an endoscopic device delivery     procedure during which the device will be anchored in the inner stomach wall at the distal     anterior antrum. Physical examination and/or endoscopic safety evaluations will be conducted     on day 14 and 28. The device and its anchor will be completely removed endoscopically after 8     weeks. The participants will be followed-up for safety evaluation for an additional period of     2 weeks.   "
221747|NCT00753363|"     Persistent low-grade inflammation and impaired fibrinolysis, are independent predictors of     several chronic diseases highly prevalent in the older Veteran population including     cardiovascular disease (CVD), stroke, and diabetes. Inflammation is likely to be a causative     underlying mechanism of insulin resistance. Lifestyle changes such as weight loss and     physical activity are advocated for the treatment of these chronic diseases and endpoints,     and data are emerging which suggest that these treatments may be beneficial, in part, due to     their anti-inflammatory effects. Identification of effective therapies that reduce chronic     inflammation for Veterans is important given the widespread adverse health effects of a     chronically elevated inflammatory state.   "
221748|NCT00753389|"     This Germany-wide, multi-center, epidemiologic study is designed to evaluate the incidence of     post-operative/anesthesia effects of muscle relaxants (i.e. post-operative residual     curarization: PORC) and their effect on patient outcome. Aside from biometric data, type of     operation, use of muscle relaxants and neuromuscular monitoring, all patients will be     clinically evaluated after their operation in the post-anesthesia care unit. To look at     long-term effects, patients will be followed-up 28 days after their operation/anesthesia     regarding post-operative/anesthesia morbidity and mortality.   "
221751|NCT00753428|"     In this study, the investigators will assess the population effectiveness of using routine     HAART as a PMTCT strategy, through a community-based survey. The survey will be done in the     catchment areas of four health clinics in rural Zambia both before and after giving routine     ART in the clinics, so as to estimate population HIV-free survival among infants born in each     target community.      The investigators hypothesize that incorporation of routine ART into PMTCT will increase the     HIV-free survival of exposed infants to 75%.   "
221752|NCT00753441|"     The prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of     tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and     gastric outlet obstruction, is the primary aim of these patients' care. Endoscopic stenting     and surgical bypass are currently the two competing treatment options. There is currently no     randomized trial comparing the recently developed metal stents to surgical bypass.     Furthermore, there is very limited data on quality of life of these patients receiving either     therapy. While endoscopic stenting represents the less invasive treatment, surgery may     provide better long-term control requiring one-time treatment. Due to the incomplete evidence     the present randomized controlled trial is designed to compare quality of life of patients     undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused     by cancer of the pancreatic head requiring with low bile duct obstruction.   "
221753|NCT00753454|"     The purpose of this study is to continue to assess the safety of certolizumab pegol in     combination with methotrexate (MTX).   "
221754|NCT00753467|"     Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by     subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or     Adefovir dipivoxil alone at a dose of 10mg QD in patients with chronic Hepatitis B.   "
221755|NCT00753480|"     This is a Phase I, multicenter, open-label, dose-escalation study of single-agent D4064A     administered by IV infusion to patients with recurrent or persistent epithelial ovarian     cancer (EOC), primary peritoneal cancer (PPC), and fallopian tube cancer (FTC) who have     previously received a platinum-containing regimen. The study will enroll up to 56 patients at     up to six investigative sites in the United States.   "
221756|NCT00753493|"     The aims of this study are to determine, in adult patients on maintenance topiramate therapy,     the steady-state pharmacokinetics and safety of orally and intravenously administered     topiramate.   "
221757|NCT00753506|"     The investigators intend to explore the hypothesis that symptoms of schizophrenia may be     reduced by the antimalarial compound artemisinin when used in addition to standard     antipsychotic medications.   "
221758|NCT00753519|"     This study will look at the effects of transcranial magnetic stimulation (TMS) on symptoms of     Parkinson's disease. TMS is a method of brain stimulation that may be able to change the     activity of the nerve cells of the brain. This study will examine the effects of a specific     pattern of stimulation called intermittent theta-burst TMS (iTBS), which uses repeated     magnetic pulses delivered in short bursts.      People with mild to moderately severe Parkinson's disease who are between 40 and 80 years of     age and whose main problems are slow movement and stiffness may be eligible for this study.      Participants undergo the following tests and procedures:        -  Random assignment to real or placebo (sham) iTBS treatment.        -  iTBS sessions (real or sham) 4 times a week for 2 consecutive weeks. For this test, the          subject sits in a comfortable chair. A wire coil is held on the subject's scalp, and a          brief electrical current is passed through the coil, creating a magnetic pulse that          stimulates the brain. The subject hears a click and may feel a pulling sensation on the          skin under the coil. There may be a twitch in the muscles of the face, arm or leg.        -  Test of gait (walk), hand and arm movements before and after each session. The gait test          requires walking 10 meters (about 30 yards) in the same corridor with the same shoes.        -  Extended testing. The first and last gait tests (done before starting iTBS and after the          eighth session) require coming off any Parkinson's medication for at least 12 hours          before the test. On these test days, subjects also undergo a clinical examination, short          neuropsychological test battery, a computer-based reaction time test and depression and          quality-of-life rating scales. These procedures are repeated in a follow-up visit 1          month after the last session.   "
221759|NCT00753532|"     The purpose of the study is to assess the neuroprotective, anti atherogenic and     hepatoprotective properties of tocotrienols (palm vitamin E) supplementation as determined by     white matter lesion load on serial magnetic resonance imaging (MRI), carotid artery magnetic     resonance angiography (MRA) and liver ultrasound (US) as well as lipid profile analysis.   "
221760|NCT00753545|"     The primary purpose of this study to determine if AZD2281 is effective and well tolerated in     maintaining the improvement in your cancer after previous platinum-based chemotherapy.   "
221761|NCT00753558|"     There is an urgent need to control our current national outbreak of carbapenem-resistant     Klebsiella pneumoniae (CRKP). The purpose of this study is to eradicate CRKP gastrointestinal     carriage using selective digestive decontamination (SDD); with buccal and oral gentamicin and     polymyxin E administration. This will reduce infections and hopefully mortality caused by     CRKP.   "
221762|NCT00753571|"     This study will examine the effectiveness of Cistanche Total Glycosides(CTG) in treating     patients with amyotrophic lateral sclerosis (ALS) - a fatal neurological degenerative disease     that causes adult-onset, progressive motor neurons loss in the spinal cord, brain stem and     motor cortex. Patients develop progressive wasting and weakness of both upper and lower     limbs, bulbar and respiratory muscles. Usually death from respiratory failure typically is     within 3-5 years of diagnosis. Although there are various treatments for ALS, riluzole is the     only approved treatment to delay the disease progression. Cistanche Total Glycosides is an     approved drug that has protective effects. It acts anti-apoptosis by activating several     protective pathways, stimulates neuronal differentiation of adult neural stem cells in the     brain, and improves long-term recovery. CTG is a highly attractive candidate for the     treatment of neurodegenerative conditions such as ALS.      Patients 18 to 65 years of age who have had mild to moderately severe ALS for 0.5 to 2 years     of duration may be eligible for this study. Candidates will be screened with a medical     history and possible review of medical records, physical examination, blood test, urine and     stool analyses, electrocardiogram, electrophysiological examination, neurological imaging     and, for women, a pregnancy test.      Participants will have drug therapy according to randomized number. One group receives CTG     while other group receives placebo. For the procedure, patients are given a medication to     lessen anxiety and any discomfort. Patients receive drugs for 9 months. The CTG dosage is     1.8g/day. Physical examination and interview, Appel ALS scale and ALS-Functional Rating Scale     will be done in 28 days and 3, 6, 9months. Electrophysiological examination will be tested     per 3 months. Blood samples will be collected on treat28 days and 3, 6, 9months.   "
221777|NCT00753792|"     This is a phase IV, multicenter, randomized, double blind clinical trial. The investigators     will study 48 patients with remitting relapsing multiple sclerosis (MS) experiencing moderate     or severe attack receiving immunomodulatory therapy or not. Patients will be randomly     assigned to one of the two groups.   "
221778|NCT00753805|"     The study was performed to investigate the effects of mare's milk on SCORAD, faecal     microbiota and immunological parameters in patients with atopic dermatitis.   "
224794|NCT00787930|"     The purpose of this study is to look at certain structural changes in the brain in people     with bipolar disorder or those with a history of Bipolar disorder.   "
221763|NCT00753597|"     This is a pilot study of B lymphocyte depletion therapy in an attempt to salvage adrenal     steroidogenic capacity in ten subjects with early autoimmune Addison's disease. During the     first twelve weeks of treatment, additional glucocorticoid therapy (prednisolone) will be     given to ensure wellbeing and to rest the steroidogenic apparatus that is the target of the     autoimmune attack. Glucocorticoids will be gradually withdrawn, in a controlled fashion, and     adrenal function re-evaluated at 13, 26, 39 and 52 weeks. The primary endpoint will be     restoration of steroidogenic function as judged by conventional endocrine indices of     adrenocortical function. B cell depletion may ameliorate the autoimmune attack against     adrenal cells, potentially allowing a state of immune tolerance to be restored with     subsequent recovery of adrenal steroidogenic capacity.   "
221798|NCT00754065|"     The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho     Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years     of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG),     norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a     21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or     headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho     Tri-Cyclen Lo.   "
221799|NCT00754078|"     The hypothesis is that helical tomotherapy could minimize radiation related toxicity by     avoiding or limiting doses to structures such as small bowel, external genitalia, skin,     bladder, rectum, and femoral neck and head.   "
221800|NCT00754104|"     Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors   "
221764|NCT00753610|"     Invasive carcinoma of the uterine cervix remains the most common invasive cancer in women in     many countries. Concurrent chemoradiotherapy (CCRT) is now recommended as a standard     treatment for locally advanced and high-risk cervical carcinoma. However, CCRT achieves a     better control of cervical cancer accompanied by greater morbidity. To avoid unnecessary     over-treatment, the optimization of CCRT is of critical importance. Herein, the development     of a surrogate marker for monitoring treatment efficacy as well as toxicity is pivotal to     optimize CCRT.      Circulating endothelial progenitor cells (EPC), derived from bone marrow, can be used as a     marker for optimizing and monitoring the anti-angiogenesis therapy including angiogenesis     inhibitors and metronomic chemotherapy. Preclinical models indicated that the source of     apoptotic circulating endothelial cells (CEC) was most likely the tumor vasculature. In     breast cancer patients, apoptotic CEC were demonstrated to be a surrogate marker for efficacy     of metronomic therapy.      In this grant, we intent to monitor the levels of circulating EPC/CEC in locally advanced     cervical cancer patients before, during and after CCRT.   "
221765|NCT00753623|"     This proposal is to conduct a double-blinded, randomized, placebo-controlled, crossover     clinical study to examine the hypothesis that ramelteon would reduce pain score and improve     functional status in subjects with neuropathic pain.   "
221766|NCT00753636|"     The objective of this study is to establish the safety and tolerability of isradipine,     sustained release preparation in patients with PD. This study is a logical continuation of     the project that is being completed now and is conducted in preparation to NIH submission of     the pivotal study on the efficacy of this agent for neuroprotection in PD. This study is     conducted in parallel with Dr. Surmeier's work on further development of the preclinical     data. The focus of his work now is to establishing the correlation between the dose that     demonstrated neuroprotective effect in animal model and the dose used for clinical practice.      Hypothesis 1: Patients with PD will be able to tolerate isradipine across the FDA recommended     dose range. We expect 10% attrition due to hypotensive effect of the agent.      Hypothesis 2: Patients with PD and concomitant stable hypertension will be able to tolerate     isradipine provided that the dose of the concomitant antihypertensive agent is adjusted based     on the blood pressure reading.   "
221767|NCT00753649|"     This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose     primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity     in different population of infants residing in Canada.   "
221768|NCT00753662|"     The primary objective of this trial is to assess the ability of Transcranial Magnetic     Stimulation with H2 coil to prefrontal and parieto-temporal cortex to improve cognitive     performance in patients with Alzheimer's disease which received drug treatment. This study is     a single-center, double-blind 4 months duration trial.   "
221769|NCT00753675|"     The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or     VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free     survival (PFS) at the trial closure in patients with advanced (unresectable or metastatic)     biliary tract cancer.   "
221770|NCT00753688|"     A randomized double blind phase III trial of Pazopanib versus placebo in patients with soft     tissue sarcoma whose disease has progressed during or following prior therapy   "
221771|NCT00753714|"     The primary objective of this study is to demonstrate an improvement in Progression-Free     Survival (PFS) for the combination of vandetanib plus gemcitabine compared with gemcitabine     plus placebo in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with     advanced NSCLC.   "
221772|NCT00753727|"     This research is being done with the aim of developing a more effective treatment than     standard radiotherapy and surgery alone. Although standard treatment is frequently     successful, some patients do not respond well to this treatment. Low oxygen levels in     tumours, which may be a particular problem with sarcomas, are thought to be one factor that     contributes to failure of radiotherapy. Sunitinib is a new drug that is active against cells     with low oxygen levels. The combination of sunitinib and radiotherapy has shown promising     results in other cancers. The purpose of this study is to find out whether treatment with a     new drug, sunitinib, can increase the effectiveness of radiotherapy at killing cancer cells;     to test the safety of the combination of sunitinib and radiotherapy.   "
221773|NCT00753740|"     This study will assess the effect of IT-101 on delaying cancer progression in patients with     platinum sensitive ovarian cancer.   "
221774|NCT00753753|"     The purpose of this study is to determine the effect of clopidogrel or aspirin reactivity as     measured by a point-of-care platelet function assay on thrombotic or bleeding events after     percutaneous coronary intervention (PCI) with drug eluting or bare metal stent.      Methods:      Platelet reactivity on clopidogrel and aspirin therapy is measured before PCI with VerifyNow     (Accumetrics Inc.,San Diego, CA, USA) P2Y12 or aspirin assay respectively in 1000 consecutive     patients from 20 centers in France undergoing coronary angioplasty with stent.      Exclusion criteria are:      Acute myocardial infarction, treatment with vitamin K antagonists and the use of antiGP2b3a     before PCI. All patients are pre-treated with clopidogrel and aspirin. Non-response to     aspirin or clopidogrel is determined according to the result of the VerifyNow assay (cut off     : < 15 % for P2Y12 and > 550 ARU for aspirin). The primary end point is the occurrence of     definite or probable stent thrombosis (ARC definition) and the secondary end-points include     global and cardio-vascular mortality, non fatal myocardial infarction and major bleeding. A     clinical evaluation is scheduled at discharge and by telephone contact at one month and one     year.   "
221782|NCT00753857|"     RATIONALE:      The way in which information about a drug is provided may affect the ability of patients and     doctors to understand how a drug works and the side effects of the drug.      PURPOSE:      This randomized trial is studying how well a drug facts page works compared with a short drug     summary in helping patients and doctors understand medical information.   "
221801|NCT00754117|"     Newly diagnosed DLCL patients will have baselne FDG-PET as part of initial staging (PET-1).     Patients will then undergo 2 cycles of chemotherapy with R/CHOP. 14 to 21 days following     cycle 2 of R/CHOP, patients will undergo repeat FDG-PET scan (PET-2). They will then complete     therapy as planned. Following completion of therapy, standard response assessment will be     performed, including CT scans of the chest, abdomen and pelvis and FDG-PET scan (PET-3).   "
221802|NCT00754130|"     The multiple dose study to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.   "
221783|NCT00753870|"     Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of     different workplaces, and is even found in homes. The endotoxin used for this study is     obtained from the National Institutes of Health, and is called Clinical Center Reference     Endotoxin, or CCRE. The purpose of this Phase 1 research study is to identify a dose of     inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other     problems), but causes changes in sputum cell samples that the scientists can measure. Phase 1     research studies like this one are not intended to be a treatment, but are a scientific     investigation. Eventually, with these types of studies we will be able to examine why some     people are more sensitive to endotoxin. Scientists at other universities have found that     while most people do not have a considerable lung response to endotoxin at doses as high as     60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our study     is designed to identify if using a dose of 20,000 EU causes changes in the lung cells but     does not cause symptoms in our study subjects. In our previous studies in our lab, using an     endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with asthma     with no major problems, and we have used 10,000 EUs of CCRE in subjects who are current     smokers without seeing any problems.   "
221784|NCT00753883|"     To compare the lipid lowering efficacy of adding ezetimibe to statin vs. statin alone.   "
221785|NCT00753896|"     This study will examine the safety of exenatide once weekly (2.0 mg) in approximately 134     patients receiving treatment with thiazolidinedione alone or thiazolidinedione in combination     with metformin. Patients are expected to be treated with exenatide once weekly for at least     52 weeks.   "
221786|NCT00753909|"     This trial will evaluate the efficacy and safety of paclitaxel, carboplatin and bevacizumab     combination, administered biweekly, in patients with pretreated, advanced non small cell lung     cancer.   "
221787|NCT00753922|"     The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round     Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary     augmentation, primary reconstruction, or revision. Safety information on the rate of capsular     contracture, rupture, and infection will be collected, and used to help determine device     safety.      Approximately 1000 patients at centers across the United States will be enrolled in this     research study. These patients will be implanted with silicone breast prostheses and     monitored for 10 years to collect information on risks associated with the implant surgery as     well as changes in the way these patients feel about themselves.   "
221788|NCT00753935|"     The purpose of this study is to evaluate possible mechanisms of aspirin resistance at a     molecular level in aspirin-treated patients with coronary artery disease. We hypothesize that     certain patient characteristics associate with aspirin resistance. In addition, we will     compare the effects of enteric-coated aspirin and chewable aspirin.   "
221789|NCT00753948|"     Previously it was observed that individuals with tetraplegia have reduced baseline airway     caliber and exhibit non-specific airway hyperresponsiveness (AHR). In persons with     tetraplegia we have suggested that this is due to overriding cholinergic airway tone. In     asthma, the mechanisms underlying bronchoconstriction and AHR are more closely tied to airway     inflammation. Whether AHR in tetraplegia is also related to chronic airway inflammation is     unknown.      Recently, a non-invasive technique for assessing airway inflammation has been established in     asthma that involves measurement of nitric oxide (NO) concentrations (FeNO) in expired air.     FeNO is elevated in asthma likely due to excess NO production by inflammatory cells within     the airway Measurement of FeNO in persons with tetraplegia would help in assessing the role     of airway inflammation in this population. This may have therapeutic significance in such     individuals. NO in the lung is felt to be the principal inhibitory neurotransmitter of the     non-adrenergic, non-cholinergic (NANC) system. It is thought that inhalation of NO has no     effect on airway tone in healthy individuals but reduces methacholine responsiveness while     having weak direct bronchodilatory effect in asthmatics.      The primary purpose of this study is to determine the levels of exhaled NO (FeNO) in     individuals with chronic cervical spinal cord injury (SCI), and to compare them with those     obtained in age and sex matched able-bodied individuals and subjects with stable mild to     moderate asthma. If the FeNO levels are high and comparable to those found in asthmatic     subjects, this will imply the role of chronic inflammation in reduced baseline airway caliber     and non-specific airway hyper-responsiveness (AHR) exhibited by individuals with chronic     cervical SCI. If the FeNO levels are comparable with those found in able-bodied controls,     this will support our previous statement that unopposed cholinergic innervation is     responsible for low baseline airway caliber and AHR in individuals with chronic tetraplegia.     Further scientific conclusions about NO and its role in control of airway tone, pulmonary     resistances and blood pressure will be drawn upon intravenous and inhaled administration of     L-NAME. This compound has been shown promising results for the treatment and prevention of     orthostatic hypotension in individuals with tetraplegia. Knowing its effects on airways and     potential of easier mode of delivery (inhalation vs. intravenous) is of utmost importance.   "
221790|NCT00753961|"     This clinical study plans to investigate the effect of the consumption of a fermented dairy     drink on the occurrence of common infections. This study will be performed in a healthy adult     population of shift workers.   "
221791|NCT00753974|"     Use biospecimens procured from patients and organ donors to improve understanding of     molecular, cellular, and tissue-level processes produced by cardiovascular disease and     therapeutic interventions   "
221792|NCT00753987|"     The objective of the study is to determine whether or not inhalation of hypertonic saline     will be tolerated by infants with cystic fibrosis and the effect of inhalation on their lung     function.   "
221793|NCT00754000|"     This study will observe patients who receive external beam radiation for prostate cancer.     These patients will be localized and tracked (targeted) with the Calypso 4D Localization     System. These patients will have a uniform treatment plan with reduced PTVs (prostate     treatment volume) and will be assessed at multiple time points for quality of life and side     effects related to radiation therapy.   "
221794|NCT00754013|"     The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride     (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome,     aged 6 to 10 years.   "
221795|NCT00754026|"     This study is designed to compare interscalene catheter insertion distances, in order to     determine which is the best for pain relief after shoulder surgery.   "
221796|NCT00754039|"     The primary objective of this study is to compare the effect of Welchol in combination with     TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients     with high cholesterol.   "
221797|NCT00754052|"     The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride     (Aricept) in the treatment of the cognitive dysfunction shown by children with Down syndrome,     aged 11 to 17.   "
221803|NCT00754143|"     The purpose of this study is to evaluate the safety and tolerability of two dosing regimens     of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria     on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor     antagonist (ARB) therapy.   "
221804|NCT00754156|"     For the last 20 to 30 years, damage control laparotomy and decompressive laparotomy have     emerged as part of the armamentariums for treatment of complex abdominal trauma, abdominal     compartment syndrome, and critically ill surgical patients with profound acidosis. While     these advances have saved lives, they have also led to a dramatic increase in patients with     open abdominal cavities. Various methods have been employed to offer protection to the     viscera and at the same time, encourage gradual closure of the abdominal fascia. Some of the     techniques have included the Bogota bag, vacuum pack described by Barker , Wittman patch ,     and the use of vacuum assisted fascia-closure, including the commercially available system     offered by KCI. Overall, the abdominal closure rate is approximately 50% to 90% over an     average of 10 days. Unfortunately, there has been no well-designed comparison study     available. Some of the best results also require returning to the operating room every 3 to 5     days.      At the University of Kentucky Medical Center, a combination of the vacuum pack dressing     described by Barker, the commercially available VAC system (V.A.C.; KCI International, San     Antonio, TX) and vicryl mesh closure systems are used. The primary fascial closure rate is     approximately 50%. It is not standard practice to take patients to the OR every 3-5 days     routinely.      Recently, a new FDA listed system (ABRA by Canica) has been introduced using a progressive     tension system as a novel approach to the management of open abdomen. ABRA provides a dynamic     reduction of full thickness, severely retracted midline abdominal defects with the goal of     maintaining or restoring the primary closure option. This subdermal method uses button     anchors and elastomer to gradually pull the wound margins together. Tension can be set and     adjusted according to the desired outcome; to stabilize a retracted wound, reduce the wound,     close the wound or prevent wound dehiscence (Attachment 1: Company brochure). Currently there     is only one published case report of the success of this device. We hope to be the first     center to prospectively report a series of patients with open abdomen managed with the new     ABRA system. In this study, this system will be used in combination with a standard therapy     used in abdominal wound closure at the University of Kentucky Medical Center. This system is     called the V.A.C system (V.A.C.; KCI International, San Antonio, Tx). This therapy provides     active exudate management and containment, assists in reducing abdominal volume and adds     structural stabilization to adipose tissue.      Although no highly powered study has been done to establish data on performance, individual     experiences at several institutions have reached fascial closure rates of higher than 70%     using the ABRA device. One institution in Las Vegas, Nevada is using the ABRA device in     combination with the VAC system and has experienced 100% closure rate to date with 12     patients. The purpose of this study is to collect information about the ABRA system in     combination with the VAC technique at the University of Kentucky Medical Center. It is our     belief that using this system will improve the fascial closure rate and thereby produce less     chance of hernia and reduce long periods of open abdominal wounds. The objective of the study     is to evaluate a novel approach for closure of open abdomen utilizing the Canica ABRA system     combined with the K.C.I. VAC System to KCI VAC System alone.   "
221805|NCT00754169|"     This study will examine the long-term outcome of brain injuries, the effects of treatment on     outcome and the effects of brain injury on people s behavior and abilities.      Men and women between 18 and 75 years of age who served in combat in the Iraq war may be     eligible for this study. It will compare test results in those who sustained a traumatic     penetrating or blast-related brain injury during combat with those who did not.      Participants undergo the following procedures over a 5-day period of testing that lasts about     6 hours a day:        -  Medical history and physical examination.        -  Blood test for genetic analysis.        -  Electroencephalography (EEG) to measure the electrical activity of the brain.        -  MRI or CT scans of the brain to look at the structure and blood flow of the brain.        -  Functional near-infrared spectroscopy (fNIRS) to monitor blood flow in the front part of          the brain blood by measuring changes in near-infrared light.        -  Neuropsychological testing, including questionnaires, pen-and-paper or computerized          tests, and performance of simple actions to measure brain function, language, memory and          other cognitive abilities..   "
221806|NCT00754182|"     The aim of this study is to compare aesthetic results of two different type of sutures     (subcuticular versus synthetic glue) in post-thyroidectomy incisions. It is a randomized     clinical trial (single blinded) designed as a superiority study, since in the authors'     hypotheses glue can give better results compared with subcuticular suture in this particular     district. Secondary objective is to investigate if other factors (like the use of cold/warm     blade, the sex, the presence of diabetes, the lenght of incision) can influence aesthetic     results.   "
221807|NCT00754195|"     This study is designed to compare thoracic epidural catheter insertion distances, in order to     determine which is the best for pain relief following a thoracotomy.      HYPOTHESIS :        1. The quality of epidural analgesia upon coughing one hour following the end of surgery          will not be inferior if the catheter is inserted 7 cm in the epidural space, versus 3          and 5 cm.        2. The quality of epidural analgesia upon coughing at 24 hour will not be inferior if the          catheter is inserted 3 cm in the epidural space, versus 5 and 7 cm.   "
221808|NCT00754208|"     This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in     treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children.     Virtually no data has been published on the use of long-acting stimulant preparations in very     young children despite early symptomatic development in a significant portion of young     children with ADHD. This would be one of the first studies looking at a long-acting     preparation of a stimulant medication in the treatment of ADHD in very young children.      Hypotheses        1. Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children.        2. Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old          children.   "
221809|NCT00754221|"     This is a study to investigate the long-term safety and effectiveness [S,S]-Reboxetine in     relieving the symptoms of Fibromyalgia in patients.   "
221810|NCT00754234|"     This study will measure nonheme iron absorption from each of the 7 daily MyPyramid menus.     Such measurements will confirm whether modifications are needed to meet dietary iron     recommendations and will provide data useful for validation algorithms to calculate dietary     iron bioavailability.   "
221811|NCT00754247|"     Keloids are thought to result from derailments in the typical wound healing process following     cutaneous injury. Current treatment options for keloids include intralesional     corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery,     including radiation and cryotherapy.      0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely     used over-the-counter medications for the treatment of keloids and hypertrophic scars.     However, their efficacy and safety have not been compared in a blinded, placebo-controlled,     prospective fashion. This study is being undertaken to determine the efficacy and safety of     HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and     keloids.      This is an investigator-blinded study, which means that the doctor evaluating you will not     know if you are receiving the study medication or not. Another doctor will be supplying you     with the medication and discussing any problems that you may have with the medication.      You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be     assigned by chance and you will have two in three chances of receiving treatment with a study     medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no     active ingredients such as steroids, silicone, vitamin E, or onion extract.   "
225417|NCT00790829|"     The efficacy of a low dose nicotine patch of seven milligrams placed before surgery and its     effect on decreasing pain after surgery is the main purpose of the study.   "
221812|NCT00754260|"     A. Statement of Objective: To conduct a randomized trial to evaluate the impact of caffeine     restriction on Overactive Bladder(OAB) symptoms including urinary frequency, nocturia,     incontinence episodes, symptom severity and bother and quality of life.      B. Specific Aims/Hypothesis:        1. To determine if reduction in caffeine intake decreases urinary frequency, nocturia and          incontinence episodes as measured on a 3-day voiding diary in women with Overactive          Bladder (OAB).           We hypothesize that women with overactive bladder will report less frequent urination          and decreased nocturia and incontinence episodes with caffeine reduction.        2. To determine whether caffeine reduction results in decreased symptom severity and bother          and improved quality of life scores as measured by the Questionnaire for Incontinence          Severity Index (ISI), Questionnaire for Urinary Incontinence Diagnosis (QUID),          Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7).      We hypothesize that women with OAB who reduce their intake of caffeine will report decreased     symptom bother and improved quality of life as measured by the ISI, UDI-6 and the IIQ-   "
221813|NCT00754273|"     To determine the prevalence of MRSA isolates with marginal susceptibility to vancomycin or     heteroresistance.   "
221814|NCT00748137|"     In pediatric patients with type 1 diabetes using subcutaneous injections; a randomised     controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to     the use of variable size meals and insulin doses determined with a bolus insulin calculation     card.   "
221815|NCT00748150|"     Annual trial for registration influenza vaccine with the strain composition for season     2008/2009   "
230265|NCT00870142|"     The purpose of this study to assess the single-dose relative bioavailability of Actavis Group     hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fasting conditions.   "
221816|NCT00748163|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Sunitinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.     Giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized     nanoparticle formulation together with sunitinib works as first-line therapy in treating     patients with stage IV non-small cell lung cancer.   "
221817|NCT00748176|"     The body shape might have influence on the spinal level. In this research we plan to     investigate the relationship of abdominal circumference, trunk length and the level of spinal     anesthesia in obstetric patients during Cesarean section.   "
221818|NCT00748189|"     The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to     chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.   "
221819|NCT00748202|"     The study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.)     administration of Berinert P in patients with hereditary angioedema (HAE) to establish a     second administration mode in cases where i.v. access is not suitable.      The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic     study.      Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert     P) and than switch to the treatment not administered before.   "
221820|NCT00748215|"     RATIONALE: Calcium aluminosilicate anti-diarrheal (CASAD) may help treat and prevent diarrhea     caused by irinotecan. It is not yet known whether CASAD is more effective than a placebo in     treating and preventing diarrhea in patients receiving irinotecan.      PURPOSE: This randomized phase II trial is studying CASAD to see how well it works compared     with a placebo in treating and preventing diarrhea in patients with metastatic colorectal     cancer receiving irinotecan.   "
221821|NCT00748228|"     One goal of this study is to determine whether people with different amounts of     dopamine-beta-hydroxylase (DBH) have different responses to events that affect blood pressure     and heart rate. We will also study whether increasing dietary salt improves symptoms during     upright posture. Finally, we will examine whether the dietary sodium level influences serum     DBH activity and whether DBH level influences the response to sodium. DBH levels and the     function of the sympathetic or involuntary nervous system will be assessed in normal     volunteers and in patients with postural tachycardia syndrome (POTS).   "
221822|NCT00748241|"     The purpose of this study is primarily to evaluate implant survival rate of Astra Tech     Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and     the implants will be loaded four weeks after implant installation (early loading). Marginal     bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects     will be followed for three years.   "
221823|NCT00748254|"     The purpose of this feasibility study is to determine if a new emerging technology called     photoacoustic tomography (PAT) can be adapted for use in humans for the detection of chronic     rheumatoid arthritis.   "
221824|NCT00748267|"     RATIONALE: Hypnosis may be effective in reducing pain and other side effects in women     undergoing surgery for breast cancer.      PURPOSE: This clinical trial is studying how well hypnosis works in reducing pain and other     side effects in women undergoing surgery for breast cancer.   "
221825|NCT00748280|"     The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with new     endodontic bio-materials) as a new treatment with one-visit root canal therapy as reference     treatment in pain relief and clinical and radiographic success, for irreversible pulpitis of     human permanent molar teeth.   "
221826|NCT00748293|"     Good colon cleansing is pivotal for achieving speedy and safe colonoscopic examination with     high adenoma detection rate.Previous studies, including our previous RCT conducted in 2004 to     2005, have demonstrated that high yield rate can be achieved by on-the-day colon preparation     with 2000 ml PEG-ELS. Poor patient compliance, however, is the main hurdle to complete     ingestion of 2000 ml PEG-ELS not only for subjects with lower body weight but also for those     with normal BMI or body weight.The main cause of poor patient compliance includes abdominal     pain, bloating, nausea or vomiting during ingestion of cleansing fluid.Though diet     restriction with low-fiber diet is always advised to every screen before colonoscopy, the     extent of diet restriction is widely variable and thus influences the degree of colon     cleansing.      With commercialized low-residue diet (CLRD), diet restriction will be well controlled and     variability of colon cleansing can be minimized such that guarantee a colonoscopy with good     quality. In this RCT, we will compare the compliance of screen during colon cleansing using     different protocol: namely 2000 ml PEG-ELS vs. 1500 ml plus low-residue diet.   "
221828|NCT00748319|"     The most frequent cutaneous T-cell lymphomas (CTCL) are mycosis fungoid and Sezary syndrome.     The diagnosis of these lymphomas is difficult using current methods, especially because     numerous benign dermatological conditions can mimick CTCL both clinically and under     microscopic examination. Recently, the KIR receptor CD158k has been shown to be a marker for     Sezary syndrome in both the blood and skin. We hypothesize that other receptors from the same     family may help fro the diagnosis of these lymphomas. To address this issue, we will study     the expression of all known KIR receptor in the skin of patients presenting with a skin     eruption, which may correspond to either a cutaneous T-cell lymphoma or a benign     dermatological disease. The final diagnosis will be established by a panel of experts,     allowing constitution of 2 groups of patients : the cutaneous T-cell lymphoma group, and the     benign inflammatory disease group. The expression of the different KIRs will be analyzed in     both group in a blinded fashion, in order to determine whether one or a several KIRs may be     differentially expressed.   "
221854|NCT00748657|"     This phase II trial studies how well bevacizumab works in treating patients with sex     cord-stromal tumors of the ovary that have come back. Monoclonal antibodies, such as     bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab     may also stop the growth of tumor cells by blocking blood flow to the tumor.   "
221901|NCT00757640|"     The patients will be divided into two groups: in the first group the patient will be     submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer     (subtotal or total gastrectomy), while in the second group will be submitted to standard     gastric surgery only.   "
221829|NCT00748332|"     Cardiac cachexia, the main feature of undernutrition in chronic heart failure, usually     defined as a weight loss over 6% over 6 months, is a proven factor of morbidity and mortality     in this disease. Its pathophysiology is complex, but proinflammatory cytokines seem to play a     major role. Omega-3 poly-unsaturated fatty acids, present in fish oil, have proven beneficial     in patients with coronary heart disease, due in part to their effects on membranes but also     due to their anti-inflammatory effects, with inhibition of TNF-α and interleukins 1 and 6.      The aim of this phase III randomized controlled double-blinded study is to assess the effects     of 8 weeks of a omega-3-enriched protein-energy supplement versus an iso-energetic     iso-nitrogenous supplement free of omega-3 fatty acids in cardiac cachexia. Thirty patients     will be included in each group. The main judgment criterion will be maximum aerobic capacity     (VO2 max), which best reflects aerobic capacity that correlates with muscle mass.     Anthropometric, biological (nutritional, inflammatory and involved in food intake control),     cardiac (functional) and quality of life will also be studied. All analyses will be performed     in intention to treat.      The investigators expect a significantly higher improvement of VO2 max in the omega-3 group.      This study could lead to therapeutic advances in a frequent and severe disease.   "
221830|NCT00748345|"     Drug pharmacokinetics of antimicrobial agents is significantly altered in the burn patients.     Additionally, burn patient population exhibits a wide inter- and intrapatient variation in     drug handling. Several investigations carried out in burn patients treated with e.g.     fluconazole showed the requirement to increase daily dose in comparison with healthy     volunteers. However, no pharmacokinetic data are available of caspofungin in the burn     population. The aim of this investigation is to investigate pharmacokinetics of caspofungin     in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal     dose in this population.   "
221831|NCT00748358|"     as second-line treatment in metastatic prostate cancer, the present study will investigate     the efficacy of sunitinib (SUTENT) given orally at a dose of 37.5 mg continuously, for 6     cycles of 6 consecutive weeks .Patients who are still responders after 6 cycles will be     treated until disease progression, pain progression, unacceptable toxicity or death due to     any cause.      Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based     on individual safety and tolerability.      Follow-up for up to 1 year from the last dose of sunitinib.   "
221832|NCT00748371|"     Aspirin has shown to be beneficial to some patients with certain diseases such as coronary     artery disease or stroke. We are investigating how aspirin works on regulating platelets and     thromboxane over time at different doses. We hope to find the best dose of aspirin and/or     other medications to help people who are at risk for heart attack or stroke.   "
221833|NCT00748384|"     The study purpose is to demonstrate that the target population can receive a packed FORESEE     HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them     for changes in the visual field with good specificity. And evaluate the device usage on a     small scale, at the subjects' homes before a commercial use.   "
221834|NCT00748397|"     The primary objective of the study is to evaluate the long-term survival rate of implants and     prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro)     using a one-stage surgical procedure.      Clinical study recruitment was stopped in year 2000 due to a decision to modify the product     under study. This was a result of feedback regarding the subjective feeling during the     installation procedure. There were no safety concerns w/r to the study products. Patients     already included and treated in the study were monitored for the full duration of the study     in accordance with the clinical study protocol.   "
221835|NCT00748410|"     This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory     white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be     contributing to the pathology of ulcerative colitis. It has been shown that SB-656933 reduces     polymorphonuclear neutrophils (PMN) accumulation in pre-clinical models of colitis.     99m-Tc-HMPAO scintigraphy is a imaging technique which will be used in this study to observe     the effect of SB656933 on the migration of PMN to inflamed tissue.   "
221836|NCT00748423|"     Acute chest syndrome (ACS) is a frequent and potentially life-threatening pulmonary illness.     It is a complication of sickle cell disease and is the leading cause of death from this     disease in adults. Several pathologic processes are recognized causes of ACS, including     infectious diseases, hypoventilation secondary to chest pain, in situ thrombosis and     pulmonary fat embolism. Inhaled nitric oxide (iNO) has been shown to be a pulmonary     vasodilatator with minimal systemic effects and has also been shown to improve gas exchange     in both animal and human acute lung injury (ALI).      The combined effects of iNO gas of improving pulmonary ventilation to perfusion matching,     reducing alveolar and systemic inflammation, modulate the course of acute chest syndrome,     which combine the physiopathology of vaso-occlusive crisis and acute lung injury.      We hypothesise inhaled NO will improve oxygenation and clinical outcome of sickle cell     disease patients with acute chest syndrome.   "
221837|NCT00748436|"     The purpose of this study is to examine the effect of betahistine on body weight in obese     female subjects   "
221838|NCT00748449|"     to evaluate the acceptability of CT-colonography compared to colonoscopy for the detection of     advanced adenomas in subpopulations at high risk of colorectal.   "
221839|NCT00748462|"     The objective of this study is to investigate the efficacy and side effects of a fractional     CO2 laser for treatment of acne scar in Asians.   "
221855|NCT00748670|"     The primary objective of the study is to evaluate the long-term survival rate of individual     implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture     MicroThread™ (Micro-Macro).      Clinical study recruitment was stopped in year 2000 due to a decision to modify the product     under study. This was a result of feedback regarding the subjective feeling during the     installation procedure. There were no safety concerns w/r to the study products. Patients     already included and treated in the study were monitored for the full duration of the study     in accordance with the clinical study protocol.   "
221899|NCT00757614|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between     genes and the environment in patients with cancer in East Anglia, Trent, or West Midlands of     the United Kingdom.   "
221841|NCT00748488|"     Patients with Parkinson's disease (PD) are heavily inclined towards a sedentary lifestyle.     This is caused by a combination of physical impairments and cognitive dysfunction. However,     regular physical activity in PD is highly desirable, for two reasons. First, physical     activity has positive generic effects in preventing complications such as cardiovascular     diseases, type II diabetes mellitus, osteoporosis and certain cases of cancer. Secondly,     physical activity has additional disease-specific merits in PD such as depression, sleep     disturbances and constipation. These effects lead to raised quality of life. Furthermore,     animal studies suggest that physical activity could slow down disease progression.      Simply informing patients about the importance of physical activity is not enough to initiate     and maintain an adequate level of physical activity. We propose to develop a physical     activity promoting program for sedentary patients with PD in order to raise their level of     daily physical activity.      Objective: The first aim of the study is to investigate whether a physical activity promotion     program will result in an increase in physical activity in sedentary patients with PD.      The second aim is to demonstrate an increase in physical fitness and quality of life.   "
221842|NCT00748501|"     The purpose of the study is to evaluate the effects of the investigational drug, SB-509 on     progression of the disease in subjects with ALS   "
221843|NCT00748514|"     To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the     potential risk factors of capsular incisions.   "
221844|NCT00748527|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and decitabine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It     is not yet known whether carboplatin is more effective with or without decitabine in treating     patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.      PURPOSE: This randomized phase II trial is studying carboplatin and decitabine to see how     well they work compared with carboplatin alone in treating patients with progressive,     advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.   "
221845|NCT00748540|"     The purpose of this investigation is to collect feasibility data to assess the safety and     efficacy of the Vibrant Soundbridge (VSB), a medical device designed to provide benefit in     aided hearing thresholds, speech perception and sound quality to certain individuals with     hearing loss with minimal changes in residual hearing. The VSB is currently indicated for     adults with moderate-to-severe sensorineural hearing loss. Under the present investigation,     adults with conductive and mixed hearing losses who are not successful users of traditional     amplification will be assessed.   "
221846|NCT00748553|"     The purpose of this clinical trial is to test whether treatment of patients with advanced or     metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in     good tumor response. All patients enrolling in this study will receive treatment with     Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and     performance status. Tumor response will be measured by RECIST criteria.   "
221847|NCT00748566|"     The purpose of this study is to explore the impact of ziprasidone on the distribution of     metabolic syndrome risk factors in a population of patients presenting with glucose     intolerance, dyslipidemia and/or elevated waist circumference associated with their current     antipsychotic medication.   "
221848|NCT00748579|"     The purpose for this study (CY 1124) is to evaluate the effects of CK-1827452, a cardiac     myosin activator, on myocardial systolic performance, myocardial oxygen consumption, and     myocardial efficiency in patients with heart failure and to confirm that the unique     preclinical pharmacological profile of CK- 1827452 is substantially the same in patients with     heart failure.   "
221849|NCT00748592|"     This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way     crossover design. Elderly subjects with primary insomnia who meet screening requirements will     initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5     mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a     polysomnography (PSG) lab.   "
221850|NCT00748605|"     1. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily          with the morning meal after a 6-week low calorie diet (LCD) of 950 kcal/day with or          without S-2367 followed by 54 weeks while on a 800 kcal deficit reduced calorie diet          (RCD) compared with placebo in medically stable and otherwise healthy obese male and          female subjects        2. To evaluate the safety and tolerability of 1600 mg/day S-2367 administered orally once          daily with the morning meal after a 6-week LCD with or without S-2367 followed by 54          weeks on a RCD compared with placebo in medically stable and otherwise healthy obese          male and female subjects        3. To evaluate the steady-state/trough pharmacokinetics of 1600 mg/day S-2367 administered          orally once daily with the morning meal after a 6-week LCD with or without S-2367          followed by 54 weeks on a RCD in obese male and female subjects        4. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily          with the morning meal during an initial 6-week LCD compared with placebo in medically          stable and otherwise healthy obese male and female subjects   "
221851|NCT00748618|"     Vitamin D deficiency accelerates vascular risk progression after kidney transplant.   "
221852|NCT00748631|"     Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant     vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the     vertebral fracture, decrease of pain. This technique also improves patient function. Namely,     bedridden patients are often able to resume walking in the days following vertebral cement     injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to     inject the cement into the diseased vertebral body which shows cortical destruction with     lower pressure, thereby possibly reducing cement leakage and related complications.      This is a multicentric, observational prospective study. Patients are evaluated before and     after the procedure.      Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of     malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be     enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at     D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient.      The main evaluation outcome is patient self-global satisfaction regarding the procedure on a     semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.   "
221856|NCT00748683|"     A falling prevention system will be established by RFID location and motion detection.        -  Using RFID to detect participants' allocation indoor.        -  Modifying environment parameters such as light, sound, to alert users if them enter a          place with potential hazards.      Data exchange models will also developed in this project        -  Interchanging different data including physiological data and RFID data into a database        -  establishing interchange protocol according the HL7 standard   "
221857|NCT00748696|"     Age-related sarcopenia is associated with increased morbidity, mortality, disability and     reduced resistance to metabolic stress. The aim of this study is to assess the effects of     resistance training, associated or not with oral nutritional supplements, on skeletal muscle     mass in sarcopenic subjects. This is a prospective randomised controlled single-centre study     that will last two years, three months for a participant.      200 healthy elderly (70-80 years old) subjects will be screened for sarcopenia by dual energy     X-ray absorptiometry. 128 sarcopenic subjects will be randomized into 4 groups:        -  group 1: controls        -  group 2: oral nutritional supplement (260 kcal and 20 g protein per day)        -  group 3: resistance training (3 times per week)        -  group 4: oral nutritional supplement + resistance training      Every subject will be assessed at the beginning and at the end of 12 weeks of intervention     on:        -  muscle mass (DXA)        -  muscle function (dynamometers)        -  hormonal (testosterone, GH, IGF-1, cortisol) and inflammatory (IL-6, TNF-alpha) profiles        -  food intake. Ten subjects in group 4 will undergo a muscle biopsy (quadriceps) before          and after the intervention in order to explore protein and mRNA levels of the mTOR          pathway, which may be involved in sarcopenia.   "
221858|NCT00748709|"     This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with     tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR     activating mutations.   "
221859|NCT00748722|"     Abdominal donor-site flaps, including the transverse rectus abdominis musculocutaneous (TRAM)     and deep inferior epigastric artery perforator flaps(DIEP), are standard in autologous breast     reconstruction. With significant variation in the vascular anatomy of the abdominal wall,     preoperative imaging is essential for preoperative planning and reducing intraoperative     error.      The quest continues for optimal preoperative assessment. Computed tomographic angiography has     recently been proposed as a noninvasive modality for this purpose. It provides the location     of the perforator vessels, diameter and anatomic course in regards to the rectus muscle.      In this study we will perform preoperative lower abdominal computed tomographic angiography     in DIEP flap breast reconstruction patients.   "
221860|NCT00748735|"     Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy     (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for     optimal definition of LV lead position.   "
221861|NCT00748748|"     Diarrhea is a common side effect of antibiotics; it may prolong hospital stay, increase the     risk of other infections, develop into more serious forms of disease, and lead to premature     discontinuation of the needed antibiotic. The purpose of this study is to examine the safety     and effectiveness of a capsule containing Lactobacillus rhamnosus GG in the prevention of     diarrhea associated with antibiotic use.   "
221862|NCT00748761|"     This study will examine the way cognitive behavioral therapy changes the structure of the     brain in patients with obsessive-compulsive disorder and will thereby determine what makes     cognitive behavioral therapy an effective treatment.   "
221863|NCT00748774|"     The goal of this study is to compare patient ratings of how severe their own symptoms may be,     with their caregivers' ratings of how severe they think the patients' symptoms may be. This     will be compared using a questionnaire that is given to patients with brain tumors and their     caregivers.      Researchers will also study any effects that these patients' neurocognitive function may have     on these patients' and their caregivers' ratings of how severe the brain cancer symptoms may     be.   "
221864|NCT00754286|"     Aromatherapy has anecdotally been reported to decrease nausea and vomiting, decrease anxiety     and increase quality of life in cancer patients. Therefore, the proposed study aims to assess     the effectiveness of aromatherapy versus placebo on nausea, vomiting, anxiety and quality of     life among pediatric oncology patients receiving emetogenic chemotherapy.   "
221865|NCT00754299|"     The Study Investigators have seen high rates of tobacco cessation success combining Chantix     with the risk of no surgery, should tobacco use continue. Once patients achieve tobacco     cessation and undergo surgery, the investigators have seen high rates of union and/or     infection resolution. The investigators are looking to document and publish these     observations. To date, no studies have been published that have examined the effects of this     type of protocol on short and long-term tobacco cessation.      The investigators want to examine and report the outcome of Hershey Medical Center's     Orthopaedic Trauma Division's protocol for two endpoints: 1) pre-op tobacco cessation and 2)     duration of tobacco cessation. This protocol involves counseling, Chantix, and a 'no-surgery'     risk. Patients will be followed postoperatively for success and duration of tobacco     cessation, as well as for fracture union and/or infection eradication.   "
221866|NCT00754312|"     The primary objective of the study is to evaluate changes in the expression of targeted     biomarkers in invasive breast cancer tissue before and after SNDX-275 administration.   "
221867|NCT00754325|"     The purpose of this study is to find out what effect the combination of fulvestrant     (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant     alone.   "
221868|NCT00754338|"     The purpose of this study is to determine if reduced lens deposits and increased comfort can     be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in     conjunction with an intensive cleaner, rather than using MPDS in a rub format.   "
221869|NCT00754351|"     This study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab     combination, administered biweekly, as salvage treatment in patients with metastatic and HER2     negative breast cancer.   "
221895|NCT00757562|"     This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks     of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or     chronic hives. All of the subjects enrolled in this trial were previously identified in an     earlier trial to be poor metabolizers of desloratadine.   "
221902|NCT00757653|"     Retrieval study and histological examination of BiMetric Femoral Components with     hydroxyapatite coatings.   "
221870|NCT00754364|"     Between 10% and 25% of newly diagnosed stage IIIB/stage IV patients currently receive single     agent chemotherapy regimens. A significant proportion of these patients will be elderly (70     years of age) and many oncologists would consider intravenous vinorelbine or gemcitabine to     be the standard of care in this patient population. It has been demonstrated that single     agent vinorelbine offers therapeutic advantages to selected NSCLC patients over best     supportive care alone.      Carboplatin plus Alimta have an acceptable toxicity profile and few clinical problems so it     could be acceptable its use in elderly patients.      A randomised study is being performed therefore to assess whether progression free survival,     the primary efficacy endpoint for this study, achieved with Carboplatin plus Alimta is     superior than achieved with gemcitabine, one of the current standards of care in elderly     patients with advanced NSCLC.   "
221871|NCT00754377|"     The Accreditation Council for Graduate Medical Education (ACGME) acknowledged the changing     needs of physicians in training when it endorsed practice-based learning and improvement     (PBLI) -- a competency that is typically omitted from medical curriculum. The goal is to have     residents competent to investigate and evaluate their own patient care practices, integrate     scientific evidence and be able to improve their practices. Available assessment tools do not     adequately address all of the components of PBLI and few assessment tools attempt to capture     the residents' ability to develop and implement clinically-based Continuous Quality     Improvement (CQI) projects that involve the practice setting. Curriculums without such foci     miss the importance of system perspectives and opportunities for interprofessional team     development. Our aim is to evaluate preliminary data on the curriculum we developed to     address the gaps, to develop an assessment tool, and to provide methods for assessing the     sustainability of system projects.      The key component of the curriculum is the integration of system quality improvement     projects. PBLI curriculum was offered on alternate rotations. Preliminary data is available     from 6 PBLI QI Systems Curriculum blocks (n=50) and 5 comparison blocks (n=42). Data includes     closed- and open-ended questions designed to assess resident PBLI application skills, the     notes and presentation slides for the residents' presentation.   "
221872|NCT00754390|"     This study is determine the effects of dietary calcium and phytate on zinc absorption.   "
221873|NCT00754403|"     The purpose of this study is to determine the efficacy of pioglitazone and metformin     combination therapy, once daily (QD), on glycosylated hemoglobin in adults with type 2     diabetes.   "
221874|NCT00754416|"     This observational study intends to collect efficacy and safety data on S.E.S shoulder system   "
221875|NCT00754429|"     To compare the effect of losartan vs amlodipine-based antihypertensive therapy on     atherosclerotic inflammatory markers and cerebrovascular regulation in Ischemic stroke     patients.   "
221876|NCT00754442|"     The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which     activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary     hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected     group of young patients with normal kidney function.   "
221877|NCT00754455|"     A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and     Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in     Healthy Adults.      Study Objectives:      Primary:        -  To assess the tolerability and safety of Influenza VLP Vaccine        -  To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination          inhibition (HAI) antibody titers to each of the three component viral strains      Secondary:        -  To evaluate the cross-strain immunogenicity of Influenza VLP Vaccine as measured by          hemagglutination inhibition (HAI) antibody titers against drifted strains        -  To quantify antibody against neuraminidase and hemagglutinin following administration of          Influenza VLP Vaccine        -  To assess cell-mediated immune (CMI) responses to Influenza VLP Vaccine as quantified by          interferon-gamma (IFNg) and Granzyme-B produced by peripheral blood mononuclear cells          (PBMCs).   "
221878|NCT00754468|"     The purpose of this study is to evaluate the treatment effect, depth of injury, and side     effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray     AblationTM, CSA or cryospray therapy) onto healthy tissue via esophagogastroduodenoscopy     (EGD) using surgical resection specimens from subjects undergoing esophagectomy.   "
221879|NCT00754481|"     The investigators hypothesize that, following cardiac arrest in pediatric patients,     hypothermia therapy will improve the proportion of patients with a good functional outcome     compared to a normothermic control group.   "
221880|NCT00754494|"     This randomized phase II trial is studying how well erlotinib hydrochloride works in treating     patients with stage I-III colorectal cancer or adenoma. Erlotinib hydrochloride may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking     blood flow to the tumor. Erlotinib hydrochloride may also stop tumors from growing or coming     back   "
221881|NCT00754507|"     To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins,     and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at     least 4 weeks.   "
221882|NCT00754520|"     The aim of this study is to demonstrate the non-inferiority of the ceramic on metal     articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same     cup.   "
221894|NCT00757549|"     RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) and     fludeoxyglucose F 18 (FDG) PET scans, may help doctors predict a patient's response to     treatment and help plan the best treatment.      PURPOSE: This pilot trial is studying FLT and FDG PET scans to see how well they evaluate     response to cetuximab, cisplatin, and radiation therapy in patients with advanced cancer of     the oropharynx, larynx, or hypopharynx.   "
225876|NCT00809289|"     This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the     effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.   "
221896|NCT00757575|"     Streptococcus pneumoniae is a major cause of pneumonia, among infants and children in Japan     and worldwideThis study plans to investigate the rate of invasive pneumococcal disease IPD      and the rate of hospitalizations due to pneumonia in Okinawa and the Eastern half of Hokkaido     Currently, only a limited information about pneumococcal disease burden is available in     Japan.   "
221995|NCT00758901|"     This observational study intends to collect efficacy and safety data on ROCC Knee system.   "
221883|NCT00754533|"     The benefits of cardiac rehabilitation have been clearly demonstrated. In particular exercise     training is recognized to be part of modern management after coronary artery disease. However     methods of prescribing exercise-training programs and the exercise intensity are difficult to     determine. The objective of this randomised clinical trial is to determine whether     appropriate endurance exercise training improves the ventilatory threshold, the exercise     tolerance and the quality of life in patients with coronary artery disease. Patients are     randomized to continuous training or aerobic interval training respectively: 80%-versus     maximal-workload at the ventilatory threshold. For each patient, the intensity of exercise     training is determined by a first exercise test with gas analysis using parameters of sub     maximal exercise capacity such as ventilatory threshold. Others parameters of functional     capacity are also considered. Duration of the rehabilitation stage is between 7 to 10 weeks.     Dyspnoea assessment at maximal intensity, quality of life measurement by SF36, drugs and     events are reported. Maximal exercise tests with gas exchange measurements are performed     after training program and at 6 months follow-up to compare the different cardio respiratory     parameters in the two groups before and after exercise training and to evaluate the more     effective endurance training program.   "
221884|NCT00754546|"     Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus     than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with     COPD. The hypothesis of the study is that patients with COPD will exhibit greater     improvements in exercise endurance and breathlessness with arformoterol compared with normal     saline during treadmill walking than with cycle exercise.   "
221885|NCT00754559|"     This single arm study will assess the effectiveness of tocilizumab in combination with     traditional DMARDs with regard to the clinical improvement in disease activity (achievement     of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have     had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients     will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable     pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular     treatment period and a further 6 infusions during an optional extension phase. The     anticipated time on study treatment is 6 to 12 months, and the target sample size is <500     individuals.   "
221886|NCT00754572|"     This single arm, open-label study will assess the safety and efficacy with regar d to     reduction of signs and symptoms of treatment with tocilizumab in combinatio n with     methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will     receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The     anticipated time on study treatment is 3-12 months, and th e target sample size is <500     individuals.   "
221887|NCT00754585|"     Back pain and chair use are the second most important health factors for the aging workforce.     Besides personal suffering, postural discomfort in the workplace reduces performance and     productivity, both of which can be improved by raising comfort levels. In an attempt to     improve comfort and reduce injury risk, ergonomic chairs are commonly equipped with lumbar     supports in an attempt to support a neutral spine. However, people often alter their     position when such a device is in place as they arch their back to conform to it. The Logic     Back support offers a simple means to alter posture and reduce associated strain on the lower     back during seated tasks by supporting the Effortless Neutral Position or the natural     curvature of the low back. Although it has been used clinically by many practitioners, its     effectiveness has yet to be shown by scientific study. The current work will help to     understand if and why the Logic Back is effective and how it can become a low-cost solution     to reduce the discomfort of those suffering from low back pain.      The purpose of this study is to determine the effectiveness of the Logic Back and the     Effortless Neutral Position in improving comfort and functional performance during seated     tasks, as compared to a standard, ergonomic chair.   "
221888|NCT00754611|"     What is the course of migraine headache recurrence, how is it managed, what characteristics     are associated with it, and how does it influence patient satisfaction with treatment?   "
221889|NCT00757484|"     The purpose of this study is to establish normal postoperative changes in blood pressure in     women undergoing scheduled gynecologic surgery requiring inpatient postoperative care. Also,     to establish if there is a difference in normal postoperative blood pressure changes between     elderly and non-elderly women undergoing scheduled gynecologic surgery requiring inpatient     postoperative care.   "
221890|NCT00757497|"     This study will test whether transcranial direct current stimulation (TDCS) can be used     safely in children with schizophrenia and if it can improve memory and attention span or     auditory hallucinations in these children, at least temporarily. TDCS has temporarily     improved memory and attention span in healthy adults and a similar method called TMS has     relieved auditory hallucinations in adults with schizophrenia. For the TDCS procedure, the     child sits in a chair and two soft sponge electrodes are placed on the child s forehead and     held in place with a soft wrapping. One sponge electrode is placed on an arm. The electrodes     are attached to a stimulator with a wire.      Children with schizophrenia who meet the following criteria may be eligible for this study:        -  Are 10 yrs or older age.        -  Are participating in NIH protocol 03-M-0035.        -  Are on a stable medication regimen for at least 6 months.        -  Have problems with memory and attention span or have auditory hallucinations.      Participants are randomly assigned to receive either real or sham TDCS on an inpatient or     outpatient basis in 20-minute sessions daily, except weekends, for 10 days. For real TDCS,     patients receive stimulation to the front of the brain. For sham stimulation, the children     have electrodes placed on the forehead, but no actual stimulation is delivered. In addition     to TDCS, patients have the following procedures:        -  Checks of blood pressure, pulse and breathing rate before, during and right after each          stimulation and again 8 hours later.        -  Electrocardiogram (EKG) and electroencephalogram (EEG) before starting stimulation and          after completing the 10 days of TDCS.        -  Interviews and examinations to check for side effects of TDCS.        -  Pen-and-paper or computer tests of learning, attention and memory.        -  At the end of the 10 sessions, children who were in the sham TDCS group are offered the          same number of sessions of active TDCS.        -  Follow-up telephone call 1 month after the end of stimulation to see how the child is          doing.        -  1- to 2-day outpatient visit 6 months after the stimulation. This visit includes          interviews with the parent and the child, rating of the child s psychiatric symptoms,          and pen-and-paper or computer tests of thinking, attention and memory.   "
221891|NCT00757510|"     The Congenital Heart Disease Research Registry (CHDRR) is a program dedicated to     understanding the etiology and improving the treatment of Congenital Heart Disease (CHD).     This Registry will act as a central coordinating center for recruiting subjects with CHD and     will provide infrastructure and guidelines for researchers studying the causes and treatment     of CHD. Investigators working directly with the Registry will have access to biological,     demographic and phenotype data from a significant pool of participants with CHD.   "
221892|NCT00757523|"     The purpose of this study is to compare the effectiveness of two marketed products in     subjects with facial acne vulgaris   "
221893|NCT00757536|"     Comparing primary PPV with 360° endolaser photocoagulation with primary PPV with an     encircling band for patients with RRDs.   "
221903|NCT00757666|"     The APPROPRIATE study will compare differences in functional capacity (peak VO2) between     chronotropically incompetent patients randomized to receive rate responsive pacing driven by     either the minute ventilation (respiration-based) sensor or an accelerometer (motion-based).   "
221904|NCT00757679|"     Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared     to placebo, in fibromyalgia out-patients   "
221905|NCT00757692|"     Purpose To define the efficacy, tolerability and safety of Vandetanib in combination with     bicalutamide in patients with chemotherapy naive hormone refractory prostate cancer      Hypothesis There will be a PSA response when Vandetanib is given in combination with     Bicalutamide in Chemotherapy Naive Hormone refractory prostate cancer patients.   "
221906|NCT00757705|"     The purpose of the study is to explore the maintained efficacy, tolerability, and safety of     flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often     with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully     treated with other oral atypical antipsychotic medication.   "
221907|NCT00757718|"     Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative     estimates, 4% of the adult female population has SDB. SDB is a recognized cause of     hypertension and treating SDB can improve blood pressure control in people with hypertension.     More recently, research efforts have looked at SDB as a possible cause of pregnancy induced     hypertension (PIH), a condition which complicates 10% of pregnancies. Traditionally, the best     way to assess SDB required patients to spend a night sleeping in the Sleep Laboratory. This     is inconvenient and for pregnant women often impossible to arrange, considering the short     time frame that exists between time of PIH diagnosis and eventual delivery. Researchers at     the University of Saskatchewan are now looking at whether an adequate sleep assessment can be     performed at the bedside - either in a patient's home or on the hospital ward. The     researchers will also look at different treatment options for sleep apnea, to see if these     can improve blood pressure control in this patient population, and delay the need for early     delivery. The information from this study may result in a detailed sleep assessment becoming     part of the complete assessment of women with PIH. There is an association between sleep     disordered breathing (SDB) and gestational hypertension (GHTN). Treatment for the SDB may     represent an effective addition to the management of the cardiovascular and metabolic     perturbations of GHTN We plan to assess women whether treating SDB with one of two methods     will improve the management of GHTN. We will also assess if one method is more effective than     the other.   "
221908|NCT00757731|"     Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the     treatment of fibromyalgia syndrome.   "
221909|NCT00757744|"     A randomized clinical trial evaluating the reduction of HIV risk behaviors and drug use when     providing integrated behavioral drug and HIV risk reduction counseling (BDRC) along with     methadone maintenance treatment in Wuhan, China   "
221910|NCT00757757|"     This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer     and bone metastases   "
221911|NCT00757770|"     The purpose of this study is to evaluate the lot-to-lot consistency of three production lots     of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged     2 months at the time of first vaccination.   "
221912|NCT00757783|"     The purpose of this research study is to compare changes in triglyceride and other lipids     (levels of fats found in the blood) from Baseline (Day 1) to Week 12 for darunavir/ritonavir     800/100 mg once daily versus atazanavir/ritonavir 300/100 mg once daily in combination with a     fixed-dose background regimen consisting of emtricitabine [FTC]/tenofovir [TDF] 200/300 mg     once daily). This study will also evaluate the safety (adverse events), effectiveness, and     tolerability of darunavir/ritonavir and atazanivir/ritonavir over 48 weeks.   "
221913|NCT00757796|"     Studies demonstrate that sleep disturbances are associated with cognitive dysfunction and     attention deficit. However the correlation between the severity of obstructive sleep apnea     and the degree of cognitive dysfunction was not demonstrated. Our hypothesis is that patients     suffering from a more severe sleep apnea will demonstrate a greater degree of cognitive     dysfunction.   "
221914|NCT00757809|"     Study to investigate the occurence of diarrhea after either once daily or twice daily dosing     for 14 days.   "
221916|NCT00757835|"     A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour     IOP control and safety of travoprost/timolol fixed combination given once in the evening,     versus that of latanoprost/timolol fixed combination given once in the evening in patients     with exfoliative glaucoma. The primary objective of this trial is to compare the quality of     24-hour IOP control after 3 months of chronic therapy with these two medications.   "
221917|NCT00757848|"     The purpose of this study is to investigate if treatment with AZD9668 for 28 days is     effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance     which does not have any action).   "
221918|NCT00757874|"     Lichen Sclerosus is an inflammatory skin condition affecting mostly the genital area of     persons of all ages, gender or race. The most frequent complaint is that of itchiness of the     vulva but pain may also occur. Some women will experience no symptoms at all. However, it is     important to treat this condition since it may increase and cause important scarring and     deformity. In less than 5% of cases, cancer may develop.      Lichen Sclerosus is a chronic disease which can be controlled but not cured. Topical     corticosteroids are the usual treatment for this condition. Though this treatment is     generally well tolerated, some patients may not present a sufficient response or may develop     mainly local and rarely systemic side effects. In this perspective, an alternative treatment     would be beneficial.      Tacrolimus, a topical immunomodulator has been approved for the treatment of atopic eczema     and has shown its efficacy in the treatment of vulvar lichen sclerosus in a limited number of     patients. Tacrolimus acts as a non-steroidal anti-inflammatory agent (NSAI) without causing     the usual side effects seen with the prolonged use of topical corticosteroids.      This study is designed to evaluate the safety and efficacy of tacrolimus in treating vulvar     lichen sclerosus by comparing it with the standard topical corticosteroid treatment.   "
222013|NCT00759148|"     The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF     Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial     conjunctivitis in patients one month of age or older.   "
221919|NCT00757887|"     In the EHMI-8 study (CMO 2006/207) the investigators induced sterile protection against P.     falciparum challenge in healthy Dutch volunteers by repeated exposure to infected mosquitoes     whilst under chloroquine prophylaxis. The surprisingly efficient induction of protection in     this study strongly supports the development of whole parasite vaccines and is therefore an     important finding to malaria vaccine development. In this study (EHMI8B) the investigators     would like to explore the longevity of the protective immune response and simultaneously     further characterise immune mechanisms responsible for protection by re-exposing EHMI-8     volunteers to infected mosquito bites.   "
221920|NCT00757900|"     Vaccination of HIV infected individuals with the sub-unit influenza vaccine is safe; however     it induces only moderate immune responses and likewise is modest in its protection compared     to HIV uninfected individuals. Based upon the available data, the South African Thoracic     Society has provisionally recommended the use of influenza vaccine in HIV infected     individuals with CD4+ counts of > 200/ml and viral loads of < 100 000 copies/ml.(Green R et     al. In press, SAMJ). This proposal is however based upon recommendations made elsewhere with     minimal level of evidence regarding its benefit, and no evidence from countries with a high     prevalence of HIV. Very few HIV infected adults, however, actually do receive influenza     vaccine in South Africa, partly because of the absence of compelling data regarding the     burden of disease in Africa as well as lack of vaccine effectiveness and issues related to     physician awareness and access to influenza vaccine in the public immunization program.      The conflicting evidence, between developed countries and Africa, regarding the effectiveness     of PPV highlight the drawbacks of extrapolating vaccine effectiveness data from developed     countries to developing countries. Differences in the epidemiology of HIV between developed     countries in which the prevalence of HIV is low to that of high-burden sub-Saharan African     countries include:        -  differences in the mode of transmission of HIV and demographics of the infected          population.        -  differences in standard of care, including access to prophylaxis against opportunistic          infections and use of highly active anti-retroviral therapy (HAART)        -  differences in risk for disease from opportunistic pathogens, e.g. Mycobacterium          tuberculosis, etc.      These differences may all contribute to differences in the risk and severity of influenza     illness among HIV infected adults from these communities as well as possibly responsiveness     and effectiveness of vaccination.      The investigators are conducting a double-blinded, placebo controlled randomized trial at the     HIV treatment clinic at Helen Joseph Hospital to determine the effectiveness of influenza     vaccination in HIV infected adults in South Africa. The significance of the findings from     this study will help quantify the burden of influenza illness in African HIV infected adults,     as well as assist in making more informed recommendations for the use of influenza vaccine in     HIV infected adults and in guiding national policy for preparing for a future influenza     virus-pandemic.   "
221921|NCT00757913|"     Background: Delirium and long-term cognitive dysfunction (CD) are important complications of     major surgery and intensive care treatment. Delirium is associated with increased mortality     and CD has an important impact on mortality, independency, social interactions, and quality     of life. Delirium is an important risk factor for the development of long-term CD.     Particularly, patients aged 65 or older undergoing cardiac surgery are at a high risk of     developing these problems. There are data suggesting that inflammation plays a key role in     the development of delirium and possibly CD. It has been shown that n-3 fatty acids modulate     the immune response of patients and have beneficial effects in abdominal surgery.      Working hypothesis: 1. Administration of n-3 enriched nutrition therapy including will     modulate the inflammatory response and improve cognitive function after cardiac surgery.      Specific Aims: This project will test the impact of perioperative enteral n-3 fatty acids     ProSure, Abbott Nutrition) in elderly patients undergoing elective cardiac surgery. Primary     endpoint is CD one week postoperatively.      Methods: The investigators will investigate 400 patients aged 65 or older undergoing elective     cardiac surgery. Half of these patients will receive supplementary of n-3 fatty acids to     modulate the inflammatory response; the other half will receive an isocaloric nutritional     supplement without n-3 fatty acids (Ensure Plus, Abbott Nutrition). Otherwise the treatment     of the patients will not be influenced by this study. Cognitive function will be assessed     preoperatively, 7 days and three months postoperatively. C-reactive protein, IL-6, IL-8,     IL-10, S-100B, and neuron specific enolase will be monitored as markers of systemic     inflammation and delirium.   "
221922|NCT00757926|"     A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate     the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated     Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] administered to     healthy Indian infants concurrently with other standard EPI vaccines would be undertaken to     evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes     G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16     weeks of age concurrently with other standard EPI vaccines would be generally well tolerated     and immunogenic.   "
221940|NCT00758173|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This study is looking at genetic susceptibility and the interactions between genes     and the environment in patients with prostate cancer.   "
223362|NCT00774436|"     The purpose of this study is to find out if men, with low-risk prostate, can have the small     amount of cancer within their prostate removed by freezing, called Focal Cryoablation or     Cryotherapy.   "
221923|NCT00757939|"     The aim of the study is to determine if regional cerebral blood flow, measured by dynamic     arterial spin labeling (dASL), can be a biomarker for stage of Alzheimer's disease. The study     is designed to be conducted in 2 parts in participants with mild to moderate Alzheimer's     disease, and participants with normal cognition. Various imaging studies will be done using     magnetic resonance imaging (MRI) and positron emission tomography (PET) along with     neurocognitive assessments. Participants who meet the study-entry criteria will have up to 8     study visits. Repeat imaging studies may be required if the initial data are incomplete or     un-interpretable. The maximum number of PET scans during the study will be limited to four.   "
221924|NCT00757952|"     RATIONALE: Studying samples of exhaled breath from patients with ovarian epithelial cancer,     polycystic ovarian syndrome, or endometriosis and from healthy participants in the laboratory     may help doctors identify and learn more about biomarkers related to cancer. It may also help     doctors find and diagnose ovarian epithelial cancer sooner, when it may be easier to treat.      PURPOSE: This clinical trial is studying exhaled breath biomarkers to see how well they find     ovarian epithelial cancer in patients with newly diagnosed ovarian epithelial cancer,     polycystic ovarian syndrome, or endometriosis and in healthy participants.   "
221925|NCT00757965|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This study is looking at genetic susceptibility for cancer and interactions between     genes and the environment in patients with colorectal cancer.   "
221926|NCT00757978|"     Memantine as an add-on therapy to clozapine may improve schizophrenia negative symptoms and     cognitive functioning.   "
221927|NCT00757991|"     RATIONALE: Studying samples of blood from healthy volunteers in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between     genes and the environment in healthy volunteers.   "
221928|NCT00758004|"     To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing     to the 80 mg commercial atorvastatin calcium tablet formulation.   "
221929|NCT00758017|"     The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with     chronic low back pain and to compare 2 different groups of patients which differ in the     acupuncture method used to treat the pain.   "
221930|NCT00758030|"     The purpose of the study was to evaluate and compare the pharmacokinetics of ER OROS     paliperidone in healthy Japanese and Caucasian patients.   "
221931|NCT00758043|"     This study is being conducted to learn more about the safety and effect of telaprevir in     combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with     hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is     designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who     respond quickly to a telaprevir-based treatment.   "
221932|NCT00758056|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between     genes and the environment in patients with endometrial cancer.   "
221933|NCT00758069|"     A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with     Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy   "
221934|NCT00758082|"     TELFIT is a monocenter, controlled, randomised trial. It focuses on type 1 diabetes patients     that have attended a functional insulin therapy training course. The Primary objective of the     TELFIT study is to evaluate whether a PDA with telemonitoring by phone reinforces the effects     of the functional insulin therapy training course as compared with conventional care.      Main judgment criteria: comparison of HbA1c means between M0 (start) and M3(3 months)   "
221935|NCT00758108|"     This study will explore conditions caused by the absence of certain genes on chromosome 11.     These conditions include WAGR syndrome, which is characterized by a kidney tumor called Wilm     s tumor, aniridia (absence of the iris of the eye), genital and urinary abnormalities, mental     retardation, and possibly other symptoms. This study will examine how the genes on chromosome     11 affect people and whether the absence of specific genes is associated with specific     symptoms.      Healthy normal volunteers, people with isolated aniridia, and people with WAGR or another     chromosome 11 gene deletion may be eligible for this study. Participants must be at least 6     years old. Parents of patients may also participate for genetic studies.      Participants undergo some or all of the following procedures, depending on whether they are a     child, adult, healthy volunteer or parent of a patient:        -  Medical history and physical examination, eye examination, blood, urine and saliva          tests, electrocardiogram (EKG) and electroencephalogram (EEG)        -  X-rays, scans and other tests to measure body composition (fat, muscle and bone          development and thickness) and MRI to examine the eyes and the brain and to measure          abdominal fat        -  Ultrasound studies of the kidneys, ovaries and uterus (in females) and testes (in males)        -  Meal tests, food diaries and food preference tests        -  Questionnaires about eating and sleep habits, personality and character traits and          responses to pain and injury        -  Neuropsychological tests        -  Tests of resting metabolic rate, energy expenditure and glucose (sugar) tolerance        -  Hot and cold sensitivity tests, vibration sensitivity test, cold tolerance test and          smell identification test        -  Eye and hearing tests        -  Nerve conduction studies and study of sensory information conduction from peripheral          nerves to the spinal cord and brain        -  Computer photography        -  Evaluation by sub-specialists (e.g., endocrinologist, ophthalmologist, physiatrist,          neurologist or others) as indicated by the patient s medical history and test results   "
221936|NCT00758121|"     The objective of the study is to determine if there is any relationship between respiratory     rate and Heart Failure events.   "
221937|NCT00758134|"     This is a prospective study assessing efficacy of trastuzumab therapy in pretreated NSCLC     patients. Patients with locally advanced or metastatic NSCLC, HER2 FISH positive and/or with     HER2 gene mutation, pretreated with at least one previous chemotherapy line will be     considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and     after signature of informed consensus form, all eligible patients will receive trastuzumab 6     mg/kg every 3 weeks (8 mg/kg loading dose) until disease progression, unacceptable toxicity     or patient refusal.   "
221938|NCT00758147|"     The purpose of this study is to assess the influence of force feedback joysticks and haptic     feedback in improving upper limb rehabilitation outcomes following stroke.   "
221939|NCT00758160|"     The purpose of this study is to evaluate whether familial relationships and psychological     status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder     (ADHD) symptoms of participants can be improved by switching from Immediate-release     Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH).   "
221941|NCT00758186|"     The objective of this randomized controlled trial was to evaluate the role colonic     self-expanding metal stent (SEMS) placement as a bridge to surgery in patients with acute     malignant left-sided colonic obstruction. The study was designed to test the hypothesis that     SEMS placement could be effectively and safely used in this group of patients to relieve     colonic obstruction thereby allowing safe recovery and medical stabilization before     proceeding to elective surgery   "
221942|NCT00758199|"     The objective of this study is to determine if an extension of bromfenac BID monotherapy is     effective in the decreasing retinal thickening post cataract IOL placement surgery. No     studies exist on how long to treat with an NSAID post cataract IOL placement surgery.     Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment,     lasting approximately 3 weeks. This study is designed to examine if there is benefit to     extending NSAID monotherapy in regards to macular thickening and the incidence of CME.   "
221943|NCT00758212|"     Influenza vaccination has proved it's effectiveness over many years of usage including     HIV/AIDS patients who are immunocompromised. In those patients, however, a noted rise in HIV     viral load which follows intramuscular injection of the vaccine is of unknown significance     over the long run. Mesotherapy is a procedure developed and practiced in france by which a     reduced and diluted amounts of antigens is being introduced by multiple intradermal     injections over the torso and upper back. Mesotherapy is mainly used as a vehicle for     introducing pain medicine and cosmetics.   "
221944|NCT00758225|"     The scientific aim of the present extension study is to monitor long-term safety and     tolerability of idebenone in patients with DMD. Furthermore, the long-term effect on     respiratory, cardiac and motor functions, and skeletal muscle strength/function will be     assessed.   "
221945|NCT00758238|"     The project includes a systematic review to inform refinement of intervention components and     a pilot RCT to determine the uptake, feasibility, and potential value of a hypertension     self-management strategy using personal health records. The review follows generally     acceptable systematic review and/or meta-analytic techniques; with specific attention devoted     towards accessing information and effectiveness data from unpublished studies or reports     within grey literature and contacting individuals with expertise in chronic disease     management in primary care. Findings of the review will be used to expand/modify an existing     intervention 'template' to yield an evidence-based strategy with potential to enhance     self-management of hypertension in primary care. The pilot RCT will assess the utility of the     multifaceted intervention, delivered in part via a secure patient-controlled personal     electronic health record, compared with the usual family practice management, for patients     with undiagnosed or uncontrolled elevated blood pressure. Patients who are hypertensive or     identified as high risk are expected to benefit from the increased flexibility and autonomy     of out-of-physician-office self-monitoring with self-management support. This initial     evaluation will focus on the change in hypertension knowledge, patient self-efficacy, and     patient engagement in self management activities after 3 months, in the intervention group     compared to the control group; the feasibility and acceptability of the intervention to     patients and providers; and the processes involved in linking the patient self-management     experience back to the patient's health care providers to promote coordination of care.     Secondary outcomes include change in blood pressure, number and content of interactions with     providers, and changes in management, including antihypertensive medication.   "
221946|NCT00758251|"     The purpose of this study is to assess severity of illness in schizophrenia patients in     routine clinical practice at the time of entry in the study and after the treatment with     Seroquel XR for 8 weeks.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
221947|NCT00758264|"     The purpose of this study is to demonstrate, in 12-23 months old subjects, the     non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when     co-administered, compared to each vaccine administered individually.   "
221948|NCT00758277|"     Prospective randomized double blind controlled trial in prevention of relapse in recently     detoxified alcohol dependent patients with levetiracetam and placebo.   "
221949|NCT00758290|"     Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3     week brushing regiment.   "
221950|NCT00758303|"     The purpose of this study is to determine the effectiveness and safety of TRIA-662 (also     known as 1-MNA) in treating elevated triglyceride levels in patients not receiving lipid     lowering treatment. This study will determine the effects of TRIA-662 on commonly measured     blood fats that are known to be important in the prevention of vascular disease.   "
221951|NCT00758316|"     Background:      Malignant pleural effusions form a significant proportion of respiratory and oncology     work-load. The efficacy of thoracoscopic talc poudrage which is the current standard of care     is limited by lung entrapment which prevents lung re-expansion. Thoracoscopy patients also     have significant hospital length of stay because chest tube drainage must continue until the     pleural space is dry to effect successful pleurodesis.      Alternative management strategies such as tunnelled pleural catheters (bedside     ultrasound-guided) enable outpatient management of pleural effusions but have limited     pleurodesis rates and do not offer any chance of getting pleural biopsies.      A prospective randomized controlled trial with two arms i.e. thoracoscopic poudrage alone     (standard care) versus combined thoracoscopic poudrage and tunnelled pleural catheters. The     tunnelled catheters will be inserted at the time of thoracoscopy in the endoscopy centre     under ultrasound guidance. The trial is aimed to be completed within 3 years. Primary     end-points will be pleurodesis success. The secondary end-points are hospital length-of-stay,     complication rates, analgesia requirements, pain scores and quality-of-life scores. Based on     power calculations, we aim to recruit 120 patients in each arm.   "
221952|NCT00758329|"     Retrospective Data Review on clinical outcomes and survivorship of ReCap Total Hip     Resurfacing   "
221953|NCT00758342|"     To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0%     (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004%     (Travatan) once daily. The study is double masked. The patients will receive either treatment     for 12 weeks.   "
221954|NCT00758355|"     Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.   "
221955|NCT00758368|"     The purpose of this study is to compare the effects of apomorphine, given by two different     methods, to determine how best to manage dyskinesias.   "
221956|NCT00758381|"     This is multicentre, open-label, randomized, phase II trial in patients with locally advanced     or metastatic pancreatic cancer. Subjects will be randomized in a 1:1 ratio to receive     gemcitabine/cisplatin in combination with Sorafenib (arm A) or gemcitabine/cisplatin alone     (arm B), as first-line chemotherapy.   "
221957|NCT00758394|"     This clinical study was to evaluate the control of dental plaque formation after     toothbrushing for 4 days with each of the 4 study toothpastes.   "
221959|NCT00758420|"     The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in     the relief of symptoms, improvement of appearance, and overall effectiveness and safety in     the treatment of varicose veins compared to placebo.   "
221960|NCT00758433|"     To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and     0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess     the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug     from civamide patch in a subset of study subjects.   "
221961|NCT00758446|"     This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare     the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge     model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety     profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden.      The aim of this study is to compare the effect, safety and tolerability of 14 days treatment     with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.   "
221962|NCT00758459|"     The primary aim of this study is to investigate the tolerability and safety of AZD 1236     compared with placebo (inactive substance) in COPD patients by assessment of Adverse     Events, vital signs and laboratory safety assessments.   "
221963|NCT00758472|"     Prospective data collection on survivorship of ReCap Total Hip Resurfacing   "
222014|NCT00759161|"     The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%,     compared to Ointment Vehicle in the treatment of plaque type psoriasis.   "
232060|NCT00889876|"     The objective is to, among obese adolescents, study impact of regular physical activity or     metformin therapy on nocturnal blood pressure and related cardiovascular disease risk     factors.   "
221964|NCT00758485|"     The current trial was designed to demonstrate faster recovery in participants undergoing     elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a     fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of     neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 Sugammadex     compared to Placebo, to evaluate the safety of 4.0 mg.kg-1 Sugammadex and to evaluate the     Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these     participants.   "
221965|NCT00758498|"     This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil     and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag     disorder.   "
221966|NCT00758511|"     Switzerland is having one of the highest premature rates in Europa and most of the preterm     neonates need neonatal intensive care. Up to 80% of the analgesic used in neonatal intensive     care units are either off label used or non-licensed used. As an alternative approach     non-pharmacological interventions for pain prevention and relief are increasingly being     recommended for the prevention and treatment of mild and moderate pain in this population.      This multicenter pilot study will use a randomized three group,repeated measures design.      The primary aims of this study of premature neonates are to:      1.) Estimate effect sizes for the impact of the proposed interventions(facilitated tucking     alone, sucrose alone and sucrose in combination with tucking)on pain reactivity.      2.) Examine the impact of gestational age on the estimates of efficacy 3.) Examine the impact     of the numbers of painful procedures the infant experiences and the concurrent use of     analgesic medications on the estimates of efficacy   "
221967|NCT00758524|"     This study is a proof-of-efficacy, dose finding study of LCI699 in patients with     mild-to-moderate uncomplicated essential hypertension in order to assess the BP lowering     effect, safety and tolerability of LCI699 as compared to placebo and eplerenone.   "
221968|NCT00758537|"     Tryptophan metabolism in kidney disease will be investigated in patients with chronic kidney     disease stages (ADOQI 3-5). Tryptophan levels and respective catabolites will be assessed     under hemodialysis.   "
221969|NCT00758550|"     The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof     Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.   "
221970|NCT00758563|"     The purpose of this study is to train new examiners while testing two commercial products     using our standard one-day brushing study regimen by measuring gingival margin plaque index.   "
221971|NCT00758576|"     The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal     Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens     following cataract removal.   "
221972|NCT00758589|"     The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled     asthmatic patients on maintenance inhaled glucocorticosteroids.   "
221973|NCT00758602|"     This 2 arm study will compare the efficacy and safety of CellCept, combined with low or     standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients     will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid +     tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or     2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3     followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study     treatment is 1 year, and the target sample size is 100-500 individuals.   "
221974|NCT00758615|"     Walking to school is one of the objectives for children and adolescents in Healthy People     2010 and in previous studies was associated with higher levels of overall physical activity,     which has been shown to decrease obesity. Therefore, more children walking to school should     result in increased physical activity and presumably reduce obesity. However, increasing     child pedestrian activity could increase the risk of child pedestrian injuries. Walking with     an adult who provides instruction in pedestrian skills and monitors the child's actual     behavior may be the most important component of a successful intervention. Walking with an     adult reduced child pedestrian injury risk by almost 70%. A walking school bus (WSB)     addresses safety concerns by providing a period of physical activity supervised by several     responsible adults and teaching opportunities around pedestrian safety skills on the way to     and from school. Children may join the WSB at various points along the set route. Despite the     growing popularity of WSB programs in the United States, randomized, controlled-studies are     lacking that examine the impact on children's safety, physical activity, and health. We seek     to help fill this gap in the literature by piloting a WSB program in elementary schools in     the Houston Independent School District to test feasibility. We hypothesize that a WSB     program will: (1) increase the number of students walking to school and decrease the number     of students driven to school by car, (2) increase students' pedestrian safety behaviors (3)     increase students' physical activity, and (4) decrease students' excess weight gain.   "
221975|NCT00758628|"     : The objective of this study is to determine if bromfenac reduces diabetic macular edema     (DME) as an adjunct to argon laser therapy (ALT). Leading cause of Blindness in the     working-aged population in the United States. 60% of patients with Type-II DM, and nearly all     with Type-I DM progress to Diabetic Retinopathy (DR) in twenty years. Diabetic Macular Edema     is the principal cause of vision loss in DR. Approximately 50% of patients with DME will     experience a loss of >=2 lines of best-corrected visualacuity (VA) after 2 years of     follow-up. The pathogenesis of DME is multifactorial and complex, but intervention stratagem     have tended to be singular. Photocoagulation laser applied directly to leaking microaneurysms     and a grid of laser has been the mainstays of treatment since the publication of the Early     Treatment Diabetic Retinopathy Study (ETDRS). This landmark clinical trial was an NIH     sponsored, multicenter, controlled study that demonstrated efficacy of laser for diabetic     macular edema. It also demonstrated that 20% of patients did not respond. Recent efforts to     improve the results are focusing on pharmaceutical interventions injected into the vitreous     cavity. The route of administration and lack of substantiated efficacy are problematic.   "
222015|NCT00759174|"     The objective of this non-interventional study is to examine whether use of Phosphodiesterase     Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset     of acute NAION.   "
222016|NCT00759187|"     The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of     commercial oral care products.   "
221976|NCT00758641|"     Rationale: The standard treatment of chronic plantar fasciitis is corticosteroid injections.     Corticosteroid injection give temporarily pain reduction, but no healing. Blood platelets     initiate the natural healing rate. GPS ® gives an eightfold concentrate platelets of patients     own blood. Injection of these platelets in the tendon might induce a healing rate.      Objective: To compare the efficacy of autologous platelet concentrate injections with     corticosteroid injection in patients suffering from plantar fasciitis with respect to pain     and function.   "
221977|NCT00758654|"     The purpose of this study is to compare the diagnostic value of SENC to that provided by     conventional wall motion analysis for the detection of inducible ischemia during     DS-MRI.High-dose dobutamine stress magnetic resonance imaging (DS-MRI) is safe and feasible     for the diagnosis of coronary artery disease (CAD) in humans. However, the assessment of cine     scans relies on the visual interpretation of regional wall motion, which is subjective.     Recently, Strain-Encoded MRI (SENC) has been proposed for the direct color-coded     visualization of myocardial strain.   "
221978|NCT00758667|"     The purpose of this study is to make available an agent,Mesna, which can assist the surgeon     during the procedure of capsulectomy.   "
221979|NCT00758680|"     This study will asses the safety, tolerability, multiple-dose pharmacokinetics and     pharmacodynamics of MK1006 in participants with type 2 diabetes.   "
221980|NCT00758693|"     Many chemotherapy combinations may be used to treat patients with chronic lymphocytic     leukemia (CLL). Although there are many options, a single, best option is not agreed upon by     most cancer specialists. Bendamustine, a medicine recently approved for use in the United     States, has been used in combination with rituximab in previous studies to treat patients     whose CLL has returned after previous standard treatments. The purpose of this study is to     determine whether bendamustine with rituximab is effective for the initial treatment of CLL     for patients aged 65 and older.   "
221981|NCT00758706|"     The primary aim of this study is to investigate the effects of AZD1236 compared with placebo     (inactive substance) in COPD patients by analysing biomarkers for inflammation and tissue     degradation in blood, urine and sputum.   "
221982|NCT00758719|"     The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion     System in patients undergoing lumbar fusion surgery.   "
221983|NCT00758732|"     This trial will compare the efficacy of docetaxel/carboplatin versus docetaxel/liposomal     doxorubicin in pretreated patients with advanced ovarian carcinoma and treatment     free-interval of at least six months   "
221984|NCT00758745|"     Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece     (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber     Opacifiation (PCO).   "
221985|NCT00758758|"     The objective of this clinical investigation is to compare patients treated with Anterior     Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a     concurrent, randomized, control group receiving autologous iliac crest bone graft or     allograft and test the hypothesis that ACDF with Hedrocel is non-inferior to ACDF with     allograft or autologous bone graft.   "
221986|NCT00758771|"     The purpose of this study is to characterize the rheological properties of cystic fibrosis     (CF) and healthy sputum and to examine the effects of mucoactive agents on the rheology of CF     and healthy sputum. By collaborating with Genentech, the investigators (scientists at UCSF)     plan to incorporate the latest scientific findings into our work to discover and develop new     treatments for CF.   "
221987|NCT00758784|"     The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution     in dry eye disease.   "
221988|NCT00758797|"     A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating     cream.   "
221989|NCT00758810|"     In secondary prevention, the beneficial role of cardiac rehabilitation programs after     myocardial infarction, percutaneous coronary intervention or coronary artery bypass is now     well established. The large majority of patients don't benefit from cardiac rehabilitation     but for those who do, they usually follow an inhospital short health educational program with     a sensibilisation to different coronary risk factors like smoking, overweight and inactivity.     The impact of these inhospital short health educational programs combined to cardiac     rehabilitation has never been totally evaluated, especially the impact on smoking cessation,     weight loss and daily physical activity.      Therefore, the present study aims to evaluate the impact at one year on 400 consecutive     patients' coronary risk profile of:        -  an inhospital short health educational program alone        -  an inhospital short health educational program combined to cardiac rehabilitation        -  a cardiac rehabilitation program alone   "
221990|NCT00758823|"     THe main goal of our randomized controlled trial with blinded observer will be to compare     four pediculicide products acting mechanically, Paranix Spray, Paranix Lotion, Paranix Mousse     and Hedrin against a reference product acting chemically, Prioderm, during a non-inferiority     (20% equivalence). THe randomization will be balanced every 10 families. The secondary     objective will be to compare the lenticide efficacy of the products and their local tolerance     and cosmetic acceptibility.   "
223391|NCT00774826|"     The purpose of this study is to define an improvement and theassessment of the Time to     Treatment Failure in patients randomized in three different arms:      R−CVP vs R−CHOP vs R−FM.   "
221991|NCT00758836|"     This study will test the safety and how effective telcagepant is when taken with ibuprofen or     acetaminophen in participants with migraine with or without aura. The primary study     hypothesis is that at least one drug combination is superior to telecagepant alone in the     treatment of acute migraines.   "
221992|NCT00758849|"     The purpose of this study is to determine whether Fipamezole is effective in the treatment of     orthostatic hypotension and related symptoms in multiple system atrophy and Parkinson's     disease.   "
221993|NCT00758862|"     A national, prospective single arm phase II study investigating the pharmacokinetics and     safety of the 2% TD1414 cream when applied 3 times daily for 7 days to adult patients with     impetigo or Secondarily Infected Traumatic Lesions (SITL). A total of 20 patients will be     enrolled.   "
221994|NCT00758888|"     A few studies concerning the effects of joint manipulation have shown muscle responses distal     to the site of manipulation. The purpose of this study is to determine if pelvic orthopedic     blocking, a low force method of manipulating the sacroiliac joint, can have produce changes     to cervical spine function.   "
221996|NCT00758914|"     Aging is associated with a variety of changes in the immune system. These changes result in a     less effective immune response, which places the elderly at a greater risk for infection and     disease. Respiratory infections cause a great number of morbidity and mortality in the     elderly population. Vitamin E has been known to improve the immune response of the elderly     and has been suggested for use in preventative strategies for this population. The purpose of     this study is to examine the effect of one year vitamin supplementation on respiratory     infection in the elderly population residing in nursing homes. This study was conducted using     a randomized, double blind, placebo controlled clinical trial at 33 long-term care facilities     in the greater Boston area. A total of 617 subjects over the age of 65 were enrolled in the     study, with 451 completers. The participants were supplemented wit either 200 IU of vitamin E     per day or placebo. The primary outcomes consisted of respiratory tract infection, number of     sick days, and antibiotic use. The study involved use of questionnaires, standard     anthropometrics measurements, non-invasive body composition, blood and urine sample     collection, and delayed type test (DTH) using the Mantoux method. This study has been closed     since August 2000 and is in the stage of data analysis only.   "
221997|NCT00758927|"     The purpose of this study is to verify the possible effects of OMACOR(omega-3 fatty acid) on     the percentage change of small dense LDL fraction in type 2 diabetic patients with combined     hyperlipidemia, we perform open-label prospective randomized multi-institutional phase IV     study.   "
221998|NCT00758940|"     An unmasked trial after bilateral implantation of AcrySof® ReSTOR®, SA60D3 IOL . Enrolled are     at least 30 patients or as much as possible from the doctor's clinical practice perspective.     6 months follow-up after IOL implant in the 2nd eye   "
221999|NCT00758953|"     This study will evaluate the efficacy and safety of an investigational medication compared     with placebo in the treatment of pain associated with endometriosis.   "
222000|NCT00758966|"     The purpose of this study is to determine if the combination of naltrexone SR and fluoxetine     is more effective in treating the symptoms of obsessive-compulsive disorder (OCD)than either     fluoxetine alone or naltrexone SR alone.   "
222001|NCT00758992|"     These studies are designed to evaluate the relative efficiency of gene transfer into     primitive human hematopoietic cells by comparing lentiviral and foamy virus vectors as     vehicles for transfer and expression of globin genes. Normal volunteers will serve as     research participants. Each will receive a 4 day course of Granulocyte-Colony Stimulating     Factor (G-CSF) after which a peripheral blood apheresis will be performed to recover a     mononuclear cell population enriched in primitive hematopoietic cells. The stem and     progenitor cells will be purified by selection based on expression of the CD34 antigen. The     CD34+ population will be cultured in vitro with various cytokines and transduced with vector     particles. The efficiency of gene transfer will be evaluated in the transduced CD34+     population, in progenitors contained within that population by culture in semisolid media and     in cells capable of establishing human hematopoiesis in immunodeficient mice. The level of     transgene expression will be evaluated in mature hematopoietic lineages that develop in vitro     or in immunodeficient mice.   "
222002|NCT00759005|"     The purpose of this study is to determine whether cortisol and propranolol are effective in     the modulation of stress induced heroin-related retrieval enhancement.   "
222003|NCT00759018|"     This protocol allows for the treatment of pediatric patients, male and female, between the     ages of 2 months and 17 years. Patients must have failed steroid treatment for Grade B-D     acute GVHD.   "
222004|NCT00759031|"     Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via     modified gingival margin plaque index method.   "
222005|NCT00759044|"     To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human     Blood-Retinal Barrier (BRB) function, in the clinical practice.   "
222006|NCT00759057|"     This non-inferiority study will compare the clinical outcomes of subjects implanted with the     Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented     posterior lateral spinal fusion.   "
222007|NCT00759070|"     This study is an open-label, randomized, pilot comparison of the effects of either     lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on     cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV     patients after 48 weeks.   "
222008|NCT00759083|"     To monitor the frequency of the development of thrombocytopenia in patients with Heparin     Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome receiving     bivalirudin during Percutaneous Coronary Intervention   "
222009|NCT00759096|"     The purpose of this study is to assess uniocular and binocular unaided distance,     intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare     testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant     of the Restor IOL.   "
222063|NCT00759824|"     The primary aim of this study is to determine if the addition of valproic acid to a     combination of adriamycin, cyclophosphamide and vindesine could increase progression-free     survival in patients relapsing after first-line chemotherapy including platinum derivatives,     cisplatin or carboplatin, and etoposide.   "
222010|NCT00759109|"     This study aims to compare the role of peginterferon α-2b (50 μg/week) vs. control (no     treatment) in the prevention of hepatocellular carcinoma, in adult patients with cirrhosis     and initial signs of portal hypertension who did not respond to previous combined therapy     with interferon alfa + ribavirin or peginterferon alfa + ribavirin or to interferon alfa     monotherapy and with a high proliferation rate before entering the study. The duration of     treatment will be 3 years, and the follow-up period will be 2 years.   "
222011|NCT00759122|"     There are two specific aims of this project:        1. To identify physiologic indicators of venlafaxine treatment response using quantitative          EEG (QEEG) cordance, and to determine if cordance changes are specifically associated          with response to venlafaxine        2. To identify predictors of placebo response in major depression using QEEG          cordance/bispectral index (BIS) and neuropsychological testing   "
222012|NCT00759135|"     This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the     treatment of BPH (benign prostatic hyperplasia) versus finasteride.   "
222017|NCT00759200|"     This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2     or 3 chronic hepatitis   "
222018|NCT00759213|"     It is well established within pediatric and neonatal medicine that social and traditionally     non-medical aspects of the home environment and conditions after discharge influence     neonatal health both in the acute and long-term setting. Government programs and laws exist     that are designed for the provision of basic pediatric health needs. Unfortunately, deficits     in obtaining those services lead to preventable poor health outcomes. Hospital social workers     and discharge planners are able to identify appropriate services, while lawyers are experts     in ensuring those rights and services are actually obtained and delivered.      West Side Health of CCHS has implemented a medical-legal partnership along the pathways     advocated by the Medical Legal Partnership for Children as part of their clinical care     services. Before implementing a similar system in the NICU, a needs assessment will be     performed first.      The purpose of this study is to determine what the health care team (physicians, nurses,     social workers, discharge planners, etc) through our discharge planning practice establishes     as the legal needs. We will collect information which is normally collected by the health     care team as a part of their usual care and assessment for discharge planning. The families     will not be approached directly by study staff.   "
222019|NCT00759226|"     This multicenter open labeled phase 2 trial examines the efficacy of a combination of     Gemcitabine 1000 mg/m2 (30 min), Cisplatin 30 mg/m2 (90 min), Folinic Acid 200 mg/m2 (30 min)     and 5-FU 750 mg/m2 (24h CI) all given day 1,8 q D22 in patients with inoperable esophageal     cancer. The combination was considered to be suitable for further evaluation with a freedom     of progression rate (PR+CR+SD) of more than 60% and not be be of further interest with a rate     of less than 40%. Given an alpha error of 5% and an beta error of 10% at least 66 evaluable     patients were needed based on a 2-Stage Simon design with a first evaluation after 25     evaluable patients.   "
222020|NCT00759239|"     The purpose of this study is to assess the IOP-lowering efficacy of a combination of     Travoprost / Timolol maleate, dosed in the morning or in the evening, in patients with     open-angle glaucoma or ocular hypertension, who have an insufficiently controlled IOP (mmHg),     and are using prostaglandin analogue monotherapy.   "
222021|NCT00759252|"     The purpose of this study is to conduct a cross-sectional survey of primary care patients to     better understand their perceptions of the risks and benefits of a screen and subsequent     diagnostic confirmation of dementia.   "
222022|NCT00759265|"     Impaired mobility is a major health problem affecting many subjects with diabetes mellitus.     It is associated with loss of quality of life and it is a strong predictor for poor health     outcomes. Reduced lower extremity muscle function, as a consequence of diabetic     polyneuropathy, is a major cause of impaired mobility. We hypothesize that a programme of     resistance training will counterbalance the effects of polyneuropathy on muscle wasting, and     will improve mobility and associated quality of life.      The objective of this study is to develop a resistance training intervention that improves     mobility and quality of life in diabetic patients. It is also our intension to achieve a     better understanding of the relation between diabetic neuropathy and muscle weakness, limited     mobility and quality of life. Moreover, insight will be gained in optimizing training     programmes for neuropathic patients.   "
222023|NCT00759278|"     This is a prospective case-control study to evaluate women who are pregnant and take     antihypertensive medication for fetal hemodynamics (middle cerebral artery peak systolic flow     and umbilical artery Doppler systolic to diastolic ratio) compared to a control group of     pregnant women not taking these kinds of medications. The hypothesis is that the     investigators expect to observe little to no difference in the comparison between the     medication group and the control group.   "
222024|NCT00759291|"     This study will test the hypothesis that reducing the release of free fatty acids (FFA) from     fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with     the metabolic syndrome.   "
222025|NCT00759304|"     The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which     permanently feed information back to this global biological vigilance system controlling     allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one     of the best indicators of ANS activity.      Low ANS activity level is associated with severe cardiac and cerebral events, as well as to     death from any cause in the general population.      This PROOF study was hence designed to evaluate ANS activity levels among a healthy retired     population, but should these levels decline overtime, to use this as a predictor of     cardiovascular and cerebrovascular events, taking into account established cardiovascular     risk factors.   "
222026|NCT00759317|"     Study Objectives:        -  to identify neurophysiologic effects of venlafaxine treatment in normal controls using          quantitative EEG (QEEG) cordance        -  to examine the effects of venlafaxine on different rating scales measuring mood and          anxiety (e.g., Ham-D, BDI, SCL-90, POMS-BI, Visual Analog Mood Scale, SSRS, SASS,          Q-LES-Q and SF-36) as well as on measures of cognitive and psychosocial function (i.e.,          Stroop, PASAT, RAVLT, Trailmaking A and B, Digit-Symbol, Grooved Pegboard,          Multidimensional Health Locus of Control, Temperament and Character Inventory,          Interpersonal Support Evaluation List, Godin Leisure-Time Questionnaire, and Pittsburgh          Sleep Quality Index) in normal control subjects, and the association of changes in          cordance with changes in thinking and memory.        -  to identify physiologic effects of venlafaxine treatment in normal controls using heart          rate and immune function measures   "
222027|NCT00759330|"     The purpose of this trial is to evaluate the analgesic efficacy and safety of flurbiprofen     tape for chronic low back pain (lasting greater than 3 months).   "
222028|NCT00759343|"     Purpose:      The purpose of the Stone Centre Serum and Urine Bank is to provide researchers with large     numbers of serum and urine samples from kidney stone patients and controls for study of stone     disease detection and treatment, and will take into account different genetic backgrounds,     ages, and other patient factors to provide a broad sample size for the study of stone disease     The Serum and Urine Bank will undoubtedly be an invaluable tool in the quest to understanding     urinary stone disease.      Objective:      The objective of this research is to identify protein species or other compounds responsible     for or contributing to kidney stone initiation and propagation.   "
222049|NCT00759629|"     The objective of this international, multicenter, randomized study is to assess whether     coronary artery stenting is associated with a reduced infarct size in patients with AMI     presenting between 12 and 48 hours after onset of symptoms compared to medical treatment     alone   "
222029|NCT00759356|"     The objective of this single-dose, open-label, randomized, two-period crossover study was to     compare the rate of absorption and oral bioavailability of a test formulation of morphine     sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division     Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x     100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered     under fed conditions.   "
222030|NCT00759369|"     Autosomal dominant polycystic kidney disease (ADPKD) is the most common single gene disorder     that is potentially fatal. ADPKD is caused by mutations in either of two genes (PKD1, PKD2).     Cysts begin to develop primarily in renal collecting tubules in utero and continue to form     and expand throughout the patient's life. One of the goals of the study is to formulate a     water prescription for use in clinical trials to determine the effect of sustained water     diuresis on the progression of ADPKD.   "
222031|NCT00759382|"     The primary aim of this non interventional study is to assess the independent prognostic role     on overall survival of primary tumour 18F-FDG uptake value (SUVmax) measured on     18fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in patients with     non-metastatic non-small cell lung cancers treated with curative intent, taking into account     the other conventional prognostic factors (performance status, age, sex, disease stage).   "
222032|NCT00759395|"     This study will determine if a highly selective enkephalinergic receptor modulator is     effective in the treatment of anxious major depressive disorder.   "
222033|NCT00759408|"     The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123,     an investigational compound which is not approved by the FDA.   "
222034|NCT00759421|"     The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine     on neurocognitive functioning in patients with schizophrenia.   "
222035|NCT00759434|"     Varicose veins are a common problem, affecting up to a third of the western adult population.     Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications     include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is     known to have a significant negative effect on patient's quality of life (QoL).      Surgery has been used for many years, but it is known that there is a temporary decline in     QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged     recovery in some patients and has the risks of infection, haematoma and nerve injury.      Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated     persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at     34 years.      26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.      Newer, less invasive treatments are being developed. It would be advantageous to find a     treatment that avoided the morbidity of surgery, one that could be performed as a day-case     procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and     allow an early return to work. These should be the aims of any new treatment for varicose     veins.      Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser     energy delivered into the vein to obliterate it. The vein therefore need not be tied off     surgically and stripped out.      The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery     and EVLT.   "
222036|NCT00759460|"     The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine     on metabolic parameters and syndrome in patients with schizophrenia.   "
222037|NCT00759473|"     The purpose of this study is to explore the use of d-cycloserine (DCS) to facilitate     extinction of response to cocaine cues in cocaine-dependent individuals, in hopes that it may     lead to the development of new treatment options for cocaine dependence.   "
222038|NCT00759486|"     The goal of this study is to establish a prospective, long-term, comprehensive growth and     development study of the pediatric craniofacial skeleton following fracture, whose     recruitment is ongoing.   "
222039|NCT00759499|"     Debridement Samples being collected for future or immediate research purposes.   "
222040|NCT00759512|"     This study is to evaluate the efficacy of the Kreiger/Kunz method of Therapeutic Touch on     function, pain perception and quality of life in persons with Osteoarthritis in the knee.   "
222041|NCT00759525|"     The purpose of this study is to figure out how decreasing the activity of 11-beta     hydroxysteroid dehydrogenase (11-beta HSD) will affect your blood vessel function. 11-beta     HSD, which is found in the kidneys and blood vessels, is a natural protein that when active     helps to keep your blood pressure under control.   "
222064|NCT00759837|"     The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and     tolerability of bosutinib in healthy subjects and subjects with liver disease.   "
222042|NCT00759538|"     The purpose of this observation study is to evaluate the effects of an early, 3 week lasting     rehabilitation program, that starts roundabout 4 weeks after lung or combined lung     transplantation, on physical activity, functional and physical condition (6-min-walk, FEV1,     ADL-score) and quality of life (SF36) in lung transplant recipients with a different length     of stay on the waiting list and a different duration of hospitalization in the     transplantation centre after transplantation.   "
222043|NCT00759551|"     The purpose of this study is to determine the safety and efficacy of azilsartan, once daily     (QD), in subjects with essential hypertension.   "
222044|NCT00759564|"     This study will evaluate what effect renal dysfunction has on a drug that has an intravenous     (CP-70,429) and an oral form (PF-03709270).   "
222045|NCT00759577|"     This is an open-label single center trial to study improvements in symptom bother and quality     of life in overactive bladder patients self titrating solifenacin 5mg and 10 mg. The study is     designed to reflect real world conditions in typical male and female OAB patients presenting     for treatment.   "
222046|NCT00759590|"     In this study the investigators aim to compare two common methods to estimate the lung     recruitment in ALI/ARDS patients.   "
222047|NCT00759603|"     The goal of this clinical research study is to learn if the combination of lenalidomide and     rituximab can help to control Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic     Lymphoma (SLL) in patients who have already received therapy. The safety of this drug     combination will also be studied.   "
222048|NCT00759616|"     Prospectively monitor the patients receiving the Oxford Partial knee arthroplasty   "
222050|NCT00759642|"     Hormone receptor positive breast cancer is the most common type of breast cancer, comprising     70-80% of all breast cancers. Endocrine therapy is the main type of initial treatment for     patients with your type of breast cancer. Endocrine therapy is treatment that tries to     remove, or block certain hormones from binding to the cancer cells and thus slow or stop the     growth of cancer. Although most patients with your type of breast cancer respond initially to     endocrine therapies, it can lose its effectiveness. New therapies for this type of cancer are     needed.   "
222051|NCT00759655|"     This study will be investigating the safety and efficacy of Xyntha (moroctocog alfa (AF-CC))     in male patients less than 6 years old. Annualized bleeding rates and physician / caregiver     assessments of responses to treatment will be characterized. FVIII inhibitor levels will be     assessed throughout the study.   "
222052|NCT00759668|"     The purpose of the study is:        -  to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety          (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series          of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or          AcrySof Natural Monofocal (Model SN60AT)        -  to assess patient satisfaction before and after implant   "
222053|NCT00759681|"     This is a prospective, multi-center randomized, controlled study. The study is designed to     assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group     in the open surgical repair of large vessels using synthetic vascular grafts or patches.   "
222054|NCT00759707|"     This study will determine whether or not saphenous vein [arterial] bypass grafts in the leg     relax in response to increases in blood flow.   "
222055|NCT00759720|"     The purpose of this study is to determine the safety and efficacy of TAK-559, once daily     (QD), combined with glyburide in treating Type 2 Diabetes.   "
222056|NCT00759733|"     Maternal cardiac disease complicates approximately 2 percent of pregnancies and is the     leading cause of non-obstetrical maternal death. Evaluating cardiac function and dysfunction     is a complex process requiring skilled clinicians and technology such as ECG, long-term     monitoring, and echocardiography. A fast, easily obtained blood test for B-type natriuretic     peptide (BNP) has been developed that can give evidence for heart muscle stretch and     dysfunction among adults with suspected congestive heart failure. Preliminary experience     indicates that ventricular dysfunction among OB patients with a history of heart disease can     be detected with this serum assay. A prospective cohort design consisting of two groups of     pregnant patients; one with a history of cardiac disease and one without, will be followed     over the course of the pregnancies and cardiac function will be measured using     echocardiography and serum BNP. It is hoped that the blood test for BNP will be a reliable     way to help evaluate OB patients with suspected abnormal heart function.   "
222057|NCT00759746|"     The purpose of this study is to determine the effect of dose and content of an enhanced     weight maintenance treatment on children's ability to maintain weight loss following a     standard weight loss treatment.   "
222058|NCT00759759|"     The objective of this single-dose, open-label, randomized, two-period crossover study was to     compare the rate of absorption and oral bioavailability of a test formulation of morphine     sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division     Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x     100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered     after a 10-hour overnight fast.   "
222059|NCT00759772|"     Decreased bone strength is a common and serious medical problem present in many women with     anorexia nervosa, or disordered eating. Women with decreased bone strength are more likely to     suffer broken bones than women with normal bone strength.      We are investigating whether a hormone that is naturally produced by the human body --     parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.   "
222060|NCT00759785|"     A study to evaluate the response of growth factor signatures (GFS) to a single dose of     dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive     luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in     the GFS in at least 40% of participants.   "
222061|NCT00759798|"     The goal of this clinical research study is to learn more about the characteristics of CLL,     including genes and chromosome abnormalities and proteins expressed by the leukemia cells,     which may help doctors predict if patients who receive standard treatment (fludarabine,     cyclophosphamide, and rituximab) for the first time will experience a complete remission.   "
222065|NCT00759850|"     Stent implantation is the best treatment in patients with acute myocardial infarction (STEMI)     referred for primary angioplasty (pPCI). However the occurrence of in stent restenosis is     responsible for the need of repeat intervention. Both Sirolimus-eluting stents (SES) and     Paclitaxel-eluting stents (PES) have been proven to virtually abolish in-stent restenosis in     elective patients in simple e more complex lesions. Both SES and PES have raised concerns     regarding occurrence of late stent thrombosis, especially in complex lesion subsets or in     high risk patients. The PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in primary     angioplasty (PASEO) trial was a prospective, single-center, randomized trial evaluating the     benefits of SES or PES as compared to BMS implantation in patients undergoing primary     angioplasty for acute STEMI. From 1 October 2003 we randomized with 1:1:1 ratio, 270 patients     with STEMI and treated with pPCI, to implantation of a bare metal stent (BMS n=90), PES     (n=90) or SES (n=90).   "
222066|NCT00759863|"     The LifeZig Project is a research study of a new reminiscence activity for individuals with     Alzheimer's Disease (AD) and other types of dementia, based on the LifeZig system, with     personalized video channels containing old photographs and music on television.      The goal of the LifeZig study is to enhance the quality of life for dementia patients and     their families/caregivers, decrease the burden of care, and contribute to positive     interaction between dementia patients and families/caregivers.   "
222081|NCT00751751|"     To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to     losartan in elderly and very elderly patients with essential hypertension. The study     hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean     sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study     duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment     hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements     are carried out at up to 18 visits during the trial.   "
222067|NCT00759876|"     Duchenne muscular dystrophy (DMD) is a genetic disorder that develops in boys. It is caused     by a mutation in the gene for dystrophin, a protein that is important for maintaining normal     muscle structure and function. Loss of dystrophin causes muscle fragility that leads to     weakness and loss of walking ability during childhood and teenage years. A specific type of     mutation, called a nonsense (premature stop codon) mutation, is the cause of DMD in     approximately 10-15% of boys with the disease. Ataluren is an orally delivered,     investigational drug that has the potential to overcome the effects of the nonsense mutation.     This study is a Phase 2a extension trial that will evaluate the long-term safety of ataluren     in boys with nonsense mutation DMD, as determined by adverse events and laboratory     abnormalities. The study will also assess changes in walking, muscle function, strength, and     other important clinical and laboratory measures.   "
222068|NCT00759889|"     The objective of this study protocol is to use wound biopsies that have been obtained during     standard of care management for further scientific evaluation after standard evaluation by a     pathologist. Further imaging and molecular analyses would closely evaluate the presence,     architecture, and interaction of wound biofilm and human host tissues.   "
222069|NCT00759902|"     The objective of this single-dose, open-label, randomized, two-treatment, two-period     crossover study was to compare the relative bioavailability of a test formulation of KADIAN     (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the     commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma     Branded Products Inc. following an overnight fast of at least 10 hours.   "
222070|NCT00759915|"     The objective of this single-dose, open-label, randomized, two-treatment, two-period     crossover study was to compare the relative bioavailability of a test formulation of KADIAN     (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the     commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma     Branded Products Inc.. Following an overnight fast of at least 10 hours, subjects consumed a     standard high-calorie, high-fat breakfast meal that began 30 minutes prior to each dose.   "
222071|NCT00759928|"     Two cohorts of patients will be enrolled: Cohort A will consist of patients who are current     smokers, and Cohort B will consist of patients who are current nonsmokers. There will be 24     patients enrolled in each cohort. Nonsmokers are patients who have not consumed tobacco or     nicotine-containing products for 1 year before the start of the study. Patients classified as     current smokers must have smoked a minimum of 10 cigarettes per day for up to 1 year.     Patients who have smoked 1-9 cigarettes per day for up to 1 year, or more than 10 cigarettes     per day for less than 1 year will not be eligible for this study.   "
222072|NCT00759941|"     The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day     to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated     intraocular pressure.   "
222073|NCT00759954|"     The objective of this single-dose, open-label, randomized, two-period crossover study was to     compare the rate of absorption and oral bioavailability of a test formulation of morphine     sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division     Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x     100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered as     a sprinkle on applesauce after a 10-hour overnight fast.   "
222074|NCT00751647|"     The purpose of this project is to determine the short-term effects of a customized Core     Strengthening and Respiratory Exercise Program (CSREP) on children with cystic fibrosis (CF)     between the ages of 10 and 21 who are receiving outpatient care at Children's Hospitals and     Clinics of Minnesota. The CSREP, which will be provided by a physical therapist and a     physical therapist assistant, consists of specific breathing techniques and core     strengthening exercises, designed to improve rib cage mobility, pulmonary function, aerobic     capacity, posture, and core strength. Currently the CF population at Children's receives     physical therapy on an inpatient basis only.      The overall goal of this program is to prove the viability of an outpatient exercise program     for this population. Specific aims include:        -  To customize a CSREP protocol per each patient        -  To measure patient outcomes at baseline and six months        -  To develop a satisfaction tool in order to measure patient experience and satisfaction   "
222075|NCT00751660|"     RATIONALE: Screening may help doctors find lung cancer sooner, when it may be easier to     treat.      PURPOSE: This clinical trial is studying screening methods to see how well they find lung     cancer early in current or former smokers.   "
222076|NCT00751673|"     This observational study intends to collect efficacy and safety data on TESS shoulder system   "
222077|NCT00751686|"     The purpose of this study is to measure the disease burden from RV GE among children less     than 5 years of age using hospital surveillance data. In addition, data collected will     determine the seasonal distribution, disease severity, age distribution of RV GE. From an     economic standpoint, the cost and impact of RV will also be assessed.   "
222078|NCT00751699|"     This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3     regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x     400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area     under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total     5-ASA percent of dose excreted (A'e [%]) over the 24-hour period on Day 7.   "
222079|NCT00751712|"     One known risk of pediatric heart surgery is the possibility for brain damage. This problem     results from a lack of oxygen rich blood flow to the brain during surgery. In order to     provide the patient's brain with blood during this operation, selective cerebral perfusion is     sometimes used. This technique allows for adequate blood flow to the brain, and is monitored     using special sticker sensors. The sensors are applied to the patient's forehead, and a     corresponding monitor indicates oxygen levels in the front part of the brain. The goal of     this study is to find out if these same stickers can be applied to the base of the skull to     measure cerebral oxygenation at the back of the brain, and to determine if the back of the     brain is adequately oxygenated during selective cerebral perfusion in patients undergoing     complex aortic arch reconstruction.   "
222080|NCT00751738|"     This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day     of azimilide in patients who completed protocol 2000098.   "
222083|NCT00759967|"     More than 80% of patients with end stage renal disease have hypertension; 70% of whom are     poorly controlled using conventional Hemodialysis therapy. An expanded extracellular fluid     volume and an increase in peripheral vascular resistance as a result of hemodynamic/trophic     effects of an increased sympathetic nerve activity, angiotensin II, asymmetrical dimethyl     arginine, and decreased nitric oxide are the most frequently quoted mechanisms contributing     to hypertension in this population. The intermittent nature of conventional hemodialysis     treatments (4 hours, 3 days/week) results in the majority of patients having a sustained     expansion of the extracellular fluid volume that likely contributes to the activation of     neurohormonal pathways. However, daily therapy including short daily hemodialysis (2 hours, 6     days/week) and nocturnal hemodialysis (6-8 hours, 5-6 days/week) improve or even normalize     blood pressure. Short daily hemodialysis appears to improve blood pressure secondary to a     reduction in extracellular fluid volume (7,8) whereas the improvement in blood pressure with     nocturnal hemodialysis occurs by a reduction in peripheral vascular resistance (8,9,10). This     is consistent with the Katzarski et al experience (7-8 hours, 3 days/week) and one randomized     controlled trial in which blood pressure control was due to normalization of extracellular     fluid volume in some patients and a reduction in peripheral vascular resistance in others.     The majority of the studies in daily dialysis are observational, do not include a run-in     period to optimize blood pressure management and have not explored the mechanisms of     improvement in blood pressure in detail. We have designed a 9 month study to determine if the     mechanism by which short daily hemodialysis is associated with an improvement in blood     pressure control is secondary to changes in sympathetic nervous system activity and/ or     extracellular fluid volume. Additionally we would like to explore the potential impact of     short daily dialysis, compared to conventional dialysis, on markers of inflammation and     oxidative stress in detail.   "
222084|NCT00759980|"     Thrombocytopenia (low platelet count) is common in the neonatal intensive care unit.     Commonly, the decision of when to transfuse platelets is based on platelet number. Recently,     Christensen et al (2006) proposed using transfusion guidelines based on platelet mass rather     than platelet number. By using platelet size as a guide of when to give platelets, we may be     able to decrease the amount platelet transfusions needed.      This study is investigating using platelet size rather than platelet number as a guideline     for transfusing platelets in infants who are hospitalized in a NICU (neonatal intensive care     unit). After obtaining parental informed consent, thrombocytopenic infants will be randomized     to one of two groups. 1: Transfusion based on platelet number; 2: transfusion based on a     combination of platelet number and platelet mass. In each group the decision to transfuse     platelets will be made using a slightly different, yet strict set of transfusion rules.      The objective is to determine the feasibility, rate of bleeding complications and compliance     of transfusing neonates based on platelet mass rather than platelet number.      The investigators hypothesize that transfusing platelets based on platelet mass will not     increase bleeding complications and will reduce the number of transfusions in     thrombocytopenic neonates.   "
222085|NCT00759993|"     A majority of patients who suffer from mental illness are treated with serotonin regulating     FDA approved medications. Some of these medications also block histamine transmission,     increase blood prolactin levels, induce insulin resistance, hyperlipidemia, and promote     sedation. All of which lead to weight gain and obesity. Many of these drugs are generally     safe and effective but do carry the risk of a long term side effect in that acute and gradual     weight gain of 10-30 pounds over a few months to a year of treatment. The detrimental gain of     7% of pre-drug weight is reported with many antipsychotics, mood stabilizers and some     antidepressants. This weight gain may subsequently add to medical co-morbidity ( ie diabetes,     hypertension, osteoarthritis, coronary artery diseasem, hyperlipidemia… ) This therapeutic     manipulation of brain serotonin functioning may be associated with abnormal increases in     carbohydrate cravings, consumption and weight gain. It is possible that insulin resistance     occurs as a direct effect or as an indirect effect of weight gain, particularly in patients     prone to weight gain or diabetes due to genetic loading. Leptin, a chemical associated with     feedback signaling that reduces appetite and adipose tissue growth may also become     insensitive. These multiple insults may lead to the worst weight gain in patients taking     clozapine, olanzapine, and mirtazapine.      Diet and exercise and lifestyle modification are the usual initial interventions, though     being depressed, anxious, bipolar, or schizophrenic often interferes with the ability to make     these changes. In fact most of the studies which look at these weight loss interventions     occur in patients who are institutionalized, on restricted diets and may respond to token     economy systems while on longer term inpatient unit stays. This token economy approach is not     easily translated to usual outpatient or short term inpatient practice settings. In these     settings, if lifestyle modification approaches fail, patients may be placed on FDA approved     diet medications (sibutramine, orlistat, ionamin…) which carry significant side effect risks.     Some patients are even placed on the epilepsy medications such as zonisamide or topiramate at     an even greater side effect risk.      In a similar weight gain prone group, there is growing literature in the diabetes population     that the use of high dose chromium improves (lowers) insulin resistance by way of increasing     insulin binding to cells, receptor numbers, and insulin receptor kinase activity. Lower     fasting blood glucose levels in the blood generally occurs. Some reports show a reduction in     blood lipid/cholesterol levels at higher chromium dosing as well. Recently, chromium     piccolinate was studied in depressed patients, especially those with atypical features     (usually fatigue, weight gain, carbohydrate cravings). Although there was no change in     depression symptoms overall, carbohydrate cravings improved. This paper was presented at the     2005 American Psychiatric Association Annual Meeting in Atlanta. As a foil, a few papers in     non-diabetics,non-depressed healthy volunteers showed little to no effectiveness in lowering     blood sugar levels. Furthermore, one investigator (JLM) has published data showing acute ,     clinically significant weightgain in serotonergically treated psychiatric inpatients. The     authors theorize that the use of chromium may reduce carbohydrate craving, appetite and thus     protect against weight gain side effects.      Given this pivotal paper in the depressed population, effectiveness data in the diabetes     population and some possible metabolic ties between these two populations, the author wishes     to study the effect of chromium piccolinate in mentally ill subjects who are being started on     serotonergic manipulating medications while in an inpatient treatment setting. These patients     will be followed during their inpatient stay and then be followed after discharge for a     single visit to determine acute interventional effects of chromium piccolinate. We feel     chromium piccolinate is less toxic/hazardous than many of the weght loss medications that we     currently use and therefore suggest a long term randomized, controlled study where subjects     will receive active drug (chromium piccolinate) or placebo at the start of any serotonergic     treatment while inpatient. The chromium piccolinate and the placbo will be obtained from the     Nutrition 21 company, which has been approved by the FDA as a source of this product.   "
222086|NCT00760006|"     The primary objective of this study is to determine the efficacy of administering a single     dose of preoperative antibiotics to prevent complications in patients undergoing primary     closure of a cleft secondary palate. Secondary objective of this study is to evaluate the     effects of preoperative antibiotics administered on post operative outcome following primary     closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic     antibiotics in cleft surgery to        -  decrease the incidence of surgical sight infections        -  speed the progression of postoperative healing        -  improve the final quality of wound healing achieved        -  decrease the rate of palatal fistula formation   "
222087|NCT00760019|"     The purpose of this study is to determine whether reducing inflammation in blood vessels with     an aspirin-like drug called salsalate will improve blood vessel function.   "
222088|NCT00760032|"     The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding     protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well     as with the development of severe infectious events in cirrhotic patients with ascites. As a     secondary purpose, the study will evaluate the effect of a prophylactic administration of     ciprofloxacin on LBP, cytokines and infections in the same patients.   "
222089|NCT00760045|"     The purpose of the study is to observe lacrimal fluid condition (tear film break-up time)     chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and     vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention     time between them.   "
222090|NCT00760058|"     The objective of the study is to compare the visual outcomes of three aspheric monofocal     intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.   "
222129|NCT00761982|"     The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset     bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered     acute middle cerebral artery stroke.   "
222091|NCT00760071|"     In patients with Cystic Fibrosis (CF) the clinical course of lung disease is crucial for     individual prognosis and life expectancy.      Imaging modalities are important in the assessment of follow up of structural lung changes     and monitoring of pulmonary complications in CF. Although high resolution computed tomography     (HRCT) is the accepted gold standard for evaluation of morphological lung changes in CF,     chest-X-ray is widely used as standard imaging procedure for assessment and follow up in     these young patients due to less radiation exposure.      Magnetic resonance imaging (MRI) has not been used for lung imaging in CF so far. Studies     from the 80's and early 90's were not able to show any impact for the use of MRI in CF. Due     to recent technical developments MRI of the lung became possible.      Our study group was able to show that MRI is a competitive imaging modality for evaluating     changes of the CF-lung in comparison to the gold standard (HRCT).      So far only patients from the age of 6-7 years were examined. According to recent studies CF     is a disease which starts in utero. Therefore it can lead to extensive pulmonary changes even     in infants and young children. In this age group lung function testing is difficult and not     broadly available. An early optimized therapy is crucial for the long term course and outcome     of the pulmonary disease.      The aim of this study is to evaluate morphological and functional MRI for early diagnosis of     lung changes in children (0-6 years) with CF.   "
222092|NCT00760084|"     The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia     (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the     DACO-018 study.   "
222114|NCT00761787|"     The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to     provide independent evidence of the clinical performance of the non-invasive AlloMap test.     Sensitive detection of cardiac allograft rejection and dysfunction is the basis for     successful recipient management. The CARGO II Study will assess the correlation between the     presence or absence of acute cellular rejection as determined by examination of     endomyocardial biopsy specimens with results from the AlloMap Test. Of 17 participating     transplant centers, 4 are in North America and 13 are in Europe.   "
222093|NCT00760097|"     People who have depression often have symptoms besides sad mood. Cognitive symptoms, such as     poor memory, concentration, and decision making, are associated with disability in many     spheres of life, and these symptoms often persist even when antidepressant treatment improves     other symptoms (mood, energy, sleep, anxiety). Antidepressants alone fail to produce full     remission for many patients, so it is important to study adjunctive treatments which can be     added onto medication treatment and help restore cognitive function. The method of     transcranial direct current stimulation (tDCS) has been shown by others to improve working     memory and cognitive functions, and also to help with other symptoms of depression. tDCS     involves passing a small, constant current between saline-moistened pads placed on the scalp.     In this proposed study, 20 individuals with major depression who have cognitive difficulties     despite taking antidepressants will participate. Over the course of a two-week period, each     person will receive 5 sessions of either active tDCS or inactive treatments, in addition to     their medication. Each session lasts for 20 minutes, and will be administered on alternating     days (M-W-F). Assessments of depressive symptoms, cognitive function, and brain activity will     be made prior to any sessions, after the first one, and after the fifth (final) session;     brain function will be assessed by measuring the brain's electrical activity (brain waves).   "
222094|NCT00760110|"     Previous cross-sectional studies have demonstrated that blood pressure (BP) measurements at     home (HBP) in the morning offer stronger predictive power for micro- and macrovascular     complications in patients with type 1 and 2 diabetes than casual/clinic blood pressure     measurements (CBP). The present study examined which of HBP or CBP provides the stronger     predictive power for outcomes by comparing cumulative events between hypertensive and     normotensive patients over 6 years in a prospective, longitudinal study of patients with type     2 diabetes.   "
222095|NCT00760123|"     OBJECTIVE: To find out the effectiveness of early application of physical therapy in the     prevention of lymphedema after breast surgery and lymphadenectomy.      DESIGN: Randomized, controlled and single blinded clinical trial. Three years duration.     Patients will be randomly assigned to one of these groups: Experimental group: Early physical     therapy + training in means of prevention; Control group: just training in means of     prevention. In both groups several physical therapy assessments will be undertaken: 1st     before surgery; 2nd immediately after surgery; 3rd after completing intervention; 4th, 5th     and 6th after 3, 6, 12 and 24 months.      SUBJECTS: Women with breast cancer treated with breast surgery including lymphadenectomy in     Principe de Asturias Hospital, provided that there is no contraindication for physical     therapy, and after reading, understanding and freely signing an informed consent form.      SAMPLE SIZE: A total of 116 subjects will be included in the study (58 subjects in each     group), assuming a 15% of drop-outs and at least 20% reduction, with a statistical power of     60%.      DATA ANALYSIS: To find out the effectiveness of intervention we will compare the rate of     lymphedema in both groups by means of a logistic regression analysis, in which the main     factor is the intervention group. Other factors aimed to control the effect of the     intervention will also be included. In order to compare the rate of appearance of lymphedema     in both groups, a survival analysis will also be included.   "
222096|NCT00760136|"     Background Previous studies have a great discrepancy concerning the effects of quadriceps     contraction on patellar lateral displacement and tilt in patients with patellofemoral pain     syndrome. This discrepancy may be caused by lack of information regarding to classifications     of patellofemoral alignment under quadriceps relaxed. We hypothesized quadriceps contraction     has different effects on each type of patellofemoral malalignment.      Methods The investigators expect to recruit 150 subjects with patellofemoral pain syndrome to     participate in this study. All patients underwent computed tomography imaging of symptomatic     knees, with and without quadriceps muscle contraction in 0°, 15° and 30° of knee flexion.     Patellar lateral condyle index and patellar tilt angles of Sasaki and modified Fulkerson were     measured to investigate the effect of quadriceps contraction on patellar repositioning.   "
222097|NCT00760149|"     In this phase II clinical trial, the pharmacokinetics, safety and (short-term) efficacy of     higher than standard doses rifampicin will be studied during the intensive phase of     tuberculosis (TB) treatment. Patients enrolled in this study will either get the standard TB     regimen (including 600 mg rifampicin; first study arm), or 900 mg rifampicin plus isoniazid,     ethambutol and pyrazinamide in standard dosages (second study arm), or 1200 mg rifampicin     plus the other drugs in standard dosages (third study arm). All patients will get the     standard TB regimen during the continuation phase of treatment.   "
222098|NCT00760162|"     The bowel can serve as a complement to the kidneys' excretory function      A specifically formulated probiotic product comprised of defined and tested microbial strains     may afford renoprotection in what has been called enteric dialysis® Confirm the alleviation     of uremic syndrome hypothesis Determine the outcome of probiotics treatment Confirm U.S.     FDA's Generally Recognized As Safe (GRAS) status - if needed   "
222099|NCT00760175|"     The influenza virus, commonly called the flu, is a common source of infection in lung     transplant patients and can often lead to pneumonia and possibly rejection. The annual     influenza vaccine is the most important strategy used to prevent infection but it is not     effective in all lung transplant patients. It has been thought that the response to the     vaccine may be improved if it is given into the skin (intradermal) rather than the muscle     (intramuscular). We hypothesize that a significantly greater proportion of patients will     respond to vaccination using the intradermal influenza vaccine compared to the intramuscular     vaccine.   "
222100|NCT00760188|"     Prospective data collection on clinical and radiographic outcomes of Cementless oxford     Partial Knee.   "
222101|NCT00760201|"     Interviewing hospital executives, physician administrators and hospital legal counsel who     work in a hospital setting (academic, governmental, private or community hospital) about     their perceptions concerning current and future end-of-life care provided in their facilities   "
222102|NCT00760214|"     The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil,     once daily (QD), compared to ramipril for treating Essential Hypertension.   "
222115|NCT00761800|"     The purpose of this study is to demonstrate the absence of irritation potential (primary     dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the     product Dermacyd Teen Care Tangerina Mix.   "
232061|NCT00889889|"     Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64     years, plus revaccination   "
222103|NCT00760227|"     The overall aim of the proposed project is to evaluate the impact of a health promotion     intervention for children undergoing bone marrow or stem cell transplant (BMT). The     intervention is complementary in nature, designed to increase the experience of positive     affect and reduce somatic distress and mood disturbance, that is, to improve overall child     well-being. The study will utilize a positive psychology model, exploring the hypothesis that     improved outcomes will be mediated by the increased experience of positive affect states     brought about by the intervention. The primary focus is on a child-targeted intervention that     includes massage therapy and humor therapy. The study will also assess whether the addition     of a similar parent-targeted intervention involving massage therapy and relaxation training     will provide significant benefits beyond those provided by the child-targeted intervention     alone. The study will utilize a 3-group design, with participants randomized to receive:1) a     child-targeted intervention (HPI-C); 2) a child targeted intervention plus a parent-targeted     intervention (HPI-CP); 3) standard care (SC). Primary outcomes include child positive affect,     somatic distress and mood disturbance, as well as measures of parental positive affect and     distress. Additional objectives of the study include examining the impact of the intervention     on short-term medical outcomes, as well as measures of child health-related quality of life     and parent and child post-traumatic stress symptoms (PTSS) at 6 months post-BMT. Analyses     will explore hypotheses specific to the positive psychology model, testing the role of     positive affect and dispositional optimism as mediators and moderators of the intervention on     child and parent well-being. We will also obtain pilot data examining the effect of the     interventions on neuroendocrine and neuroimmune markers of stress.   "
222104|NCT00760240|"     The investigators are interested in seeing how people with low vision (decreased visual     acuity or restricted visual fields) instill eye drops into their own eyes. The investigators     hypothesis is that this population will have more difficulty with self-instillation of drops     than a better-seeing population. The investigators aim to explore whatever factors may be     involved in preventing this population from getting prescribed eyedrops into their eyes,     whether it is more related to visual field or visual acuity.   "
222105|NCT00760253|"     This study is to find the fewer side effects formula of anesthesia for TVOR patients, to     compare the BIS level during emergence and to find the correlation between BIS and     transcutaneous carbon dioxide concentration.   "
222106|NCT00760266|"     The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed     dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in     older population with Stage 2 systolic hypertension.   "
222107|NCT00760279|"     The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of     IV azithromycin in preterm neonates and confirm that the pharmacokinetics of azithromycin is     similar in the 24-<32 week and 32-<37 week neonate. The dose of 10 mg/kg has been chosen on     the basis of previous pediatric pharmacokinetic studies.   "
222108|NCT00760292|"     Background: Genetic risk-markers associated with T2DM are thoroughly studied. So far, only a     few genetic variants, also termed single nucleotide polymorphisms (SNP's), have been     replicated in several studies and each of them gives only limited explanation for the growing     incidence of T2DM. The hypothesis of the present study is that determination of combinations     of genetic variants by SNP-chip technology may improve the prediction of T2DM, complications     and efficacy of treatment compared to the methods previously used including genome wide     association (GWA) studies. The SNP-chip/ DNA microarray makes it possible to study several     SNP's association with T2DM, one by one but also in combination.      Aims: To study whether specific genetic variants, and combinations of these, 1) are present     with higher prevalence in patients with T2DM than in the normal population, 2) are associated     with specific diabetes-related complications and 3) the effect of the anti-diabetic     treatment.      Methods: During the next three years 1000 patients with T2DM and 1000 healthy, non-diabetic     persons will be included in the study, and examined by blood samples, a questionnaire and     clinical evaluation, all in one visit. Initially, we will perform DNA analyses on blood     samples from 372 patients included in another clinical study from our department. Description     of genetics will be done by a DNA-chip with approximately 70 SNP's, which have previously     been reported to be associated with T2DM.      Results and conclusions: It is expected that the result of this project can help us     predicting T2DM, diabetes-related complications and individualizing treatment to the     individual patient with T2DM.   "
222109|NCT00761722|"     The purpose of this study is to compare the amount of drug that gets into the bloodstream     between different tablets taken by mouth and an injection under the skin.   "
222110|NCT00761735|"     Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants     who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin     (RBV) and who completed the follow-up in the P02538 Part 1 study (NCT00104052). No study drug     therapy will be administered during the P02538 Part 2 study. Durability of virologic response     will be assessed for participants who attained sustained virologic response (SVR) in Part I     of this study by performing annual Hepatitis C Virus ribonucleic acid (HCV-RNA) testing. In     addition, this study will characterize long-term safety in all participants who received     PEG-IFN plus RBV treatment.   "
222111|NCT00761748|"     Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.   "
222130|NCT00761995|"     Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing     Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension   "
222147|NCT00762229|"     The purpose of this study is to compare the effect on LDL cholesterol levels of converting     patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10     milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.   "
226036|NCT00812591|"     The study seeks to use microdialysis and microperfusion techniques to assess the feasibility     of combining insulin delivery and glucose sensing at a single subcutaneous tissue site.   "
222112|NCT00761761|"     The investigators hypothesis is that oral Sensoril® (as compared to placebo) will enhance     cognitive abilities (specifically measures of attention, executive function, working memory,     and visuospatial ability) in persons with bipolar disorder. Secondarily, the investigators     hypothesize there will be secondary improvements in residual mood/anxiety symptoms, and     metabolic indices, if impaired (fasting blood glucose and lipids).      The investigators aim to test these hypotheses by conducting a randomized, placebo     controlled, add on treatment trial of Sensoril® (added to existing mood stabilizer treatment)     recruiting 60 subjects with DSM IV-TR bipolar disorder for a period of 8 weeks. Measures of     cognition, psychopathology and laboratory indices will be utilized for evaluating primary and     secondary outcomes, along with safety assessments.   "
222113|NCT00761774|"     The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16     years and older with epilepsy. This study permits continued access to treatment for subjects     who participated in a previous epilepsy study. The study will explore the long-term safety     and efficacy of brivaracetam.   "
222116|NCT00761813|"     Each year, hip fracture, an injury that can impair independence and quality of life, occurs     in about 280,000 Americans and 36,000 Canadians. The annual healthcare costs associated with     this injury are expected to soon reach $9.8 billion in the United States and $650 million in     Canada. It is important to have in place optimal practice guidelines for the surgical     handling of this injury. One type of hip fracture, called a femoral neck fracture, is often     treated with a surgical procedure called internal fixation. When performing internal     fixation, most orthopaedic surgeons favor using multiple small diameter screws over using a     single large diameter screw with a sliding plate. However, use of the sliding hip screw might     in fact result in fewer complications after surgery and reduce the need for a second surgery,     called a revision surgery. This study will compare the two different surgical procedures to     determine which one results in better outcomes after surgery.   "
222117|NCT00761826|"     The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in     the treatment of mixed astigmatism up to 6.0 D, when used as part of the Laser In Situ     Keratomileusis (LASIK) procedure.   "
222118|NCT00761839|"     The purpose of this research study is to evaluate a patient education program for chronic     wound care. The wound care nurse practitioner (NP) at the Ann Arbor VAMC will use a wound     self-management after-care summary with approximately half of her patients. This study will     examine whether using this patient education tool for self-management of wound care results     in improved patient outcomes.   "
222119|NCT00761852|"     Ruboxistaurin is being tested to see if it is effective in treating certain diabetic     complications, such as diseases of the blood vessels.   "
222120|NCT00761865|"     The purpose of this study is to compare the short term treatment outcome measures of the     standard of care air cell stirrup brace to that of a high tide fracture boot in patients with     lateral ankle sprains.   "
222121|NCT00761878|"     The purpose of this study is to determine the comparative effects of the PlasmaJet neutral     argon plasma system and the Rhytec Portrait PRS nitrogen plasma system in the treatment of     aging facial skin   "
222122|NCT00761891|"     The purpose of this study is to obtain a reference range for a newly developed assay of ex     vivo platelet COX-1 activity in normal volunteers taking a routine clinical dose of aspirin.   "
222123|NCT00761904|"     In this randomized controlled trial, we will provide primary care physicians with free     samples of highly effective generic cardiovascular medications. We will test whether this     intervention will stimulate cost-effective prescribing, reducing drug costs and improving     adherence to essential cardiovascular medications.   "
222124|NCT00761917|"     The objectives of this study are to assess for a difference between normal and dry eye     subjects in tear film quality using a diagnostic interferometry device and to determine     whether there are associations between tear film quality and dry eye symptoms and signs.   "
222125|NCT00761930|"     Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival     inflammation   "
222126|NCT00761943|"     We are trying to see if ultrasound is a good tool for looking at the changes that happen on     the inside of the shoulder due frozen shoulder.   "
222127|NCT00761956|"     The purpose of this study is to test for significant differences in functional outcomes,     specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a     NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative     range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.   "
222128|NCT00761969|"     The PID-PAB study aims to test the efficacy of the European Guidelines on Cardiovascular     Disease Prevention in patients with peripheral arterial disease. Survival, the rate of major     atherothrombotic events (myocardial infarction, stroke, critical limb ischemia) and the     incidence of revascularization procedures will be compared between a group of patients with     stable peripheral arterial disease (PAD) and age- and sex-matched control subjects without     PAD. Both groups will be receiving up-to-date medical care according to their cardiovascular     risk based on the European Guidelines on Cardiovascular Disease Prevention in Clinical     Practice. Yearly follow-up is planned for 5 years. The PID PAB study aims to test (a) whether     stable PAD is still an adverse prognostic indicator in spite of contemporary preventive     measures, and (b) to what extent do contemporary preventive measures improve the prognosis of     patients with PAD in comparison to historic controls, representing the natural history of the     disease.   "
222131|NCT00762008|"     The purpose of this research is to determine if two proteins in the blood are increased     during acute heart failure. These two proteins are produced when the heart becomes     dysfunctional and unable to contract normally. They may then be released into the blood and     be detected by standard method in the research laboratory. Thus, the purpose of this study is     to determine the relation between the change of these two proteins in the blood and the     occurrence of acute heart failure. At this time, detection of an increase in these proteins     in the blood is not known to be associated with any disease or heart failure.   "
222132|NCT00762021|"     To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof     SN60AT lens or the AcrySof SN60WF lens.   "
222133|NCT00762034|"     This study will compare overall survival in participants with Stage IIIB or IV nonsquamous     non-small cell lung cancer.   "
222134|NCT00762047|"     The purpose of this study is to evaluate a new injectable bulking agent for the treatment of     fecal incontinence in adult men and women. This study has been designed to assess the safety,     effectiveness and performance of Durasphere in adults suffering from fecal incontinence under     monitored clinical conditions.      The frequency and severity of fecal incontinence symptoms will be measured using a modified     Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.   "
222135|NCT00762060|"     This study is a multicenter, open label, observational, postmarketing surveillance study of     the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to     investigate specific aspects of infection rates and hospital length of stay following routine     use of this device in patients undergoing colorectal surgical procedures.   "
222210|NCT00763061|"     To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004%     compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension     (OH). The study structure is a parallel design. The patients will receive treatment for 12     weeks.   "
222136|NCT00762073|"     This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with     eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of     four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit     the clinic at study weeks 0 (Baseline Visit), 2, 4, 8 and 12 (Final Treatment Evaluation) for     clinical symptom assessment and safety evaluation (including adverse events and vital signs).     All study treatments (active drug and placebo) will be administered orally twice daily during     the Treatment Period, once in the morning after breakfast and once in the evening at bedtime.   "
222137|NCT00762086|"     The purpose of this study is to evaluate the safety and efficacy of new intermittent     pneumatic compression device on initial claudication distance in patients with Peripheral     Arterial Disease stage II   "
222138|NCT00762099|"     Pain prior to surgery is of particular concern in patients undergoing total hip arthroplasty     (THA) since it is the most important predictor of pain and poor function 2-3 years after     surgery. Previous studies have investigated various treatments for managing pain during and     after surgery. However, no study has investigated the short and long term effects of     pregabalin in terms of functional rehabilitation, pain outcome and anxiety following total     hip arthroplasty. Therefore, the aim of the present study is determine if the following: (1)     if perioperative pregabalin administration positively influence early rehabilitation and     recovery of physical function and to determine if these effects maintained at 6 weeks and 3     months post surgery. (2) To determine if perioperative pregabalin administration reduce     postoperative movement evoked pain associated with rehabilitation and if these effects also     maintained at 6 weeks and 3 months post surgery.   "
222139|NCT00762112|"     The purpose of this study was to determine the long-term safety of TAK-559, once daily (QD),     in subjects with Type 2 Diabetes.   "
222140|NCT00762125|"     Fibromyalgia syndrome (FMS) refers to a set of symptoms that include exhaustion, muscle pain,     and tender points, where slight pressure can cause pain. Doctors do not know what causes FMS     or how to cure it, but some treatments have helped relieve its symptoms. Progressive     exercise, in which exercise is started at low levels and then increased, is one of the most     reliable treatments, but people with FMS often avoid exercise or stop after completing     exercise programs. This research will focus on the idea that people with FMS do not exercise     because they are afraid of injury or have had a negative experience exercising. Participants     will undergo one or a combination of several different treatments that aim to reduce fear of     exercising. The different treatments will then be evaluated on their effectiveness in     reducing disability among people with FMS.   "
222141|NCT00762138|"     AutoloGel™ Post-Market Surveillance Program      Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including     coagulopathies in patients with wounds to which AutoloGel™ was applied.      Design:Prospective, open label, patient registry. Investigator Sites: 3 Enrollment Size: 300      Subject Population: Patients with exuding wounds, such as leg ulcers, pressure ulcers, and     diabetic ulcers and for the management of mechanically or surgically-debrided wounds.      Primary Objective Safety: Assess the incidence of hematologic (coagulopathies), immunologic     (including anaphylaxis) and other adverse events associated with the application of AutoloGel     on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers and during the     management of mechanically or surgically-debrided wounds.      Primary Safety Endpoint: Absence of coagulopathies caused by inhibitors to coagulation Factor     V as determined by a significant prolongation of the prothrombin (PT) time and confirmed by     severe depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V     functional inhibitors.   "
222142|NCT00762151|"     The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype     dentrifice as compared to commercial control products following a single use of the     dentrifice.   "
222143|NCT00762164|"     The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved     agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption     inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter,     versus a whole simvastatin 20 milligram tablet.   "
222144|NCT00762177|"     To compare the antimicrobial efficacy of three dentifrices on oral bacteria   "
222145|NCT00762190|"     The purpose of this study was to determine the safety of TAK-559, once daily (QD), in     treating subjects receiving a stable dose of insulin to control type 2 diabetes mellitus.   "
222146|NCT00762216|"     To assess the rotational stability and the residual refractive cylinder and patient reported     outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.   "
222148|NCT00762242|"     The purpose of this study is to identify and characterize specific chemicals and metabolic     pathways that change with forearm ischemia. These changes will be compared with forearm blood     flow and flow-mediated vasodilation of the brachial artery.   "
222149|NCT00762255|"     The purpose of the this study is to see if an investigations cancer treatment called     vorinostat can be combined with the irinotecan/bevacizumab regimen safely.   "
222150|NCT00762268|"     S-adenosyl-L-methionine (SAMe) is a dietary supplement with antidepressant properties. SAMe's     mechanism of action remains unclear, but it appears to be distinct from that of conventional     antidepressants. The purpose of this study is to examine the effect of these properties on     the mood of bipolar subjects with persistent major depression that has been unresponsive to     standard pharmacotherapy.   "
222151|NCT00762281|"     The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in     the treatment of hyperopia, when used as part of the Laser In Situ Keratomileusis (LASIK)     procedure.   "
222185|NCT00762723|"     Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion     device for use in the lumbar or sacral spine (L1-S1) to treat instability. The system     provides the surgeon with the ability to supplement an interbody device with anterior plate     fixation. The device's bone-plate interface is enhanced through use of fixed-angled     screws,variable-angle screws or a combination of both to accommodate various combinations of     screw configurations, resulting in enhanced fixation tailored to individual patient needs.     Clinical outcomes data, including a comparison of different screw configurations, is needed     to support the use and of the Trinica ALP System.   "
222186|NCT00762736|"     The purpose of this study is to determine the efficacy of pioglitazone, once daily (QD),     combined with azilsartan in the treatment of subjects with Type 2 Diabetes Mellitus.   "
222152|NCT00762294|"     Aromatase Inhibitors (AI) are effective for secondary prevention of breast cancer and may     soon replace tamoxifen as first-line therapy in the treatment of hormone-sensitive breast     cancer. However, because these medications produce a marked reduction in serum estrogen     levels, this is likely to result in an increased rate of bone loss and risk of developing     osteoporosis and fractures in postmenopausal women treated with these agents. Indeed,     substantial bone loss has been reported in several large clinical trials of AIs. Osteoporosis     drugs are available that could prevent this loss, but they have frequent side effects and are     expensive. Thus, treating all women receiving AIs might not be the most appropriate and     cost-effective approach. A better approach might be to select women at highest risk of bone     loss and only treat them with antiresorptive agents.      The proposed pilot study will evaluate women who receive anastrozole or letrozole therapy,     are receiving adequate amounts of calcium and vitamin D and have baseline normal or     moderately low bone mass in order to determine if early changes in bone turnover markers     correlate with bone loss at one year. If data from this pilot protocol support our     hypothesis, then we would propose a larger trial to confirm it. The ultimate aim is to     predict which women are at higher risk of bone loss and therefore treat them earlier with     bone-sparing agents, while those with lower risk could be monitored on conservative therapy.   "
222153|NCT00762307|"     The purpose of this study is to evaluate a non-invasive cooling device to determine if cold     exposure will consistently result in a reduction of subcutaneous fat.   "
222154|NCT00762320|"     Kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective     medications that are approved and available for young children who are HIV+. The liquid form     is reported to have a very nasty taste and presents difficulties for the children who must     take the medication twice a day and for their parents who must enforce the medication     regimen. The children are often well into their teens before they weigh enough to be able to     take the adult dose tablet (200mg/50mg). A new smaller dose tablet (100mg/25mg) is now     available. However, it is not known if the liquid and tablet act the same in children. The     purpose of this study is to switch children from the baseline treatment with the liquid to     the study intervention treatment with 100mg/25mg tablet form of Kaletra. The study will     compare children pre-switch and post-switch in terms of how well their HIV is controlled .     Comparisons of parent and child satisfaction will also be made. Eight to 10 HIV+ children     currently well managed with a medications including liquid Kaletra will be invited to switch     from the liquid to the low dose Kaletra tablet. The parent and/or child will complete a     satisfaction survey for the liquid Kaletra and lab values will be taken from the chart. At     the time of the switch and 1, 3 and 6 months post switch blood tests will be drawn and the     parent and/or child will complete the satisfaction survey. In addition, at the switch and 1     month post switch, a day will be spent in clinic with 5 blood draws to see how much of the     drug is in the blood stream at different times after the medicine is taken.   "
222155|NCT00762333|"     The purpose of this research is to determine if two proteins in the blood are increased     during acute myocardial infarction and whether their levels are higher in those who develop     heart failure than those who do not. These two proteins are produced and potentially released     when the heart muscle is damaged. They may then be released into the blood and be detected by     standard method in the research laboratory. At this time, detection of an increase in these     proteins in the blood is not known to be associated with any disease or myocardial     infarction.   "
222156|NCT00762346|"     A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of     high-level NTX non small cell lung cancer with bone metastasis.   "
222157|NCT00762359|"     The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to     gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and     duodenal ulcers in patients receiving long term treatment with low dosage aspirin.   "
222158|NCT00762372|"     The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as     an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in     term of awakening/recovery from anesthesia.   "
222159|NCT00762385|"     The objective of this study is to evaluate the clinical performance of two silicone-hydrogel     contact lenses.   "
222160|NCT00762398|"     The Masimo monitor can measure hemoglobin level noninvasively and accuratly   "
222181|NCT00762671|"     The purpose of the study is to learn how blood vessel function is altered by diabetes. We are     studying an investigational drug, Ebselen, to see if it can improve the ability of blood     vessels to relax (widen).   "
222182|NCT00762684|"     The purpose of this study was to determine the safety and efficacy of TAK-559, once daily     (QD), in treating subjects with type 2 diabetes mellitus.   "
222183|NCT00762697|"     The intent of this protocol is to obtain blood samples from subjects with or without a wound,     so the blood can be used in wound-related scientific studies. It is also the intent of this     protocol to salvage debrided wound material that is normally destined for destruction, so it     can be used in wound-related scientific studies.   "
222184|NCT00762710|"     The purpose of this study is to determine whether the drug prazosin is effective for the     treatment of alcohol dependency.   "
224079|NCT00785408|"     A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine     the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or     overweight subjects.   "
222187|NCT00762749|"     To characterize the pharmacokinetics of diphenhydramine in two pediatric populations:     children, ages 2 to < 12 years, and adolescents, ages 12 to < 18 years.   "
222188|NCT00762762|"     Clinical research study to determine the anti-plaque efficacy of commerical dentifrices.   "
222189|NCT00762775|"     We will study the relative importance of high calcium intake and vitamin D supplementation     for calcium homeostasis, as determined by serum parathyroid hormone (PTH) and biochemical     bone markers. We also intend to examine the interaction of vitamin D and calcium intake on     calcium homeostasis. We hypothesize that optimal calcium supplementation and optimal vitamin     D supplementation will lead to lower serum levels of PTH and markers of bone resorption     compared with the placebo. We also theorize that when taken together, optimal calcium     supplementation and optimal vitamin D intake will result in lower serum levels of PTH and     bone markers compared with calcium or vitamin D taken alone.   "
222161|NCT00762411|"     Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no     cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta amyloid     (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD     patients are required to have these amyloid plaques in the brain in order to have a     definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the     production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and     was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in     blood, spinal fluid and brain in animals tested thus far. This study used several different     tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some     patients. The buildup of amyloid plaques was measured by a brain scan that takes a picture of     amyloid plaques in the brain. Other tests measured the overall function of the brain and     brain size in some patients. In this trial, patients who initially received placebo (inactive     sugar pill) were, at a certain point in the study, switched over to active drug,     semagacestat. In other words, all patients could eventually receive active drug. Each     patient's participation could last approximately 2 years. Patients taking approved AD     medications were permitted to participate in this study and continue taking these medications     during the study. All patients who completed this study had the option to continue receiving     semagacestat by participating in an open label study.      Preliminary results from this study (LFBC) (and another similar study LFAN [NCT00594568])     showed semagacestat did not slow disease progression and was associated with worsening of     clinical measures of cognition and the ability to perform activities of daily living. Study     drug was stopped in all studies. LFBC, LFAN and open label LFBF (NCT01035138) have been     amended to continue collecting safety data, including cognitive scores, for at least seven     months. The CT-Registry will reflect results of analyses from the original protocol in     addition to those from the amended protocol.   "
222162|NCT00762424|"     Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several     studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been     carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4     mg with placebo in regards to rate and time of stone passing and will also look at amount of     pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on     time to stone passage and pain relief in Emergency Department patients with kidney stones.   "
222163|NCT00762437|"     The purpose of this study is to evaluate a non-invasive cooling device to determine if cold     exposure will consistently result in a reduction of subcutaneous fat.   "
222164|NCT00762450|"     To determine the effect of an amino acid on bacterial glycolytic acid formation in human     interdental plaque.   "
222165|NCT00762463|"     This is a local, multicenter, randomized, active comparator, double-blind, parallel group     study with extension will be conducted to evaluate the efficacy and safety of celecoxib     versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).   "
222166|NCT00762476|"     The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the     common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a     virus that causes many common colds.   "
222167|NCT00762489|"     Body temperature measurement is one of the standard vital sign measurements in newborn babies     in order assess their health status. Temperatures are taken on a regular basis throughout the     newborn's stay on the well-baby floor. A temperature that is elevated above the normal range     for age or depressed below the normal range for age may be a sign of illness in a newborn.     There are many methods that may be used to record this temperature. Traditionally, axillary     (under the arm) and rectal (in the rectum) sites have been used. Recently, a new method of     temperature measurement has become available. Temporal artery thermometers are a non-invasive     method to measure the baby's temperature by means of a light that is shone on the forehead     that can read your baby's temperature quickly. It is not clear whether this method is     accurate in the newborn period.      The purpose of this study is to evaluate the accuracy of temporal artery temperature     measurement. This will be achieved by observing the axillary measurement, rectal temperature     measurement, and temporal artery temperature measurement taken at approximately the same time     in each infant. These measurements will be compared to each other to determine if temporal     artery thermometry is as reliable a measurement as rectal and / or axillary temperature     measurements.      We plan to compare      Hypothesis: Temporal artery thermometry of the immediate newborn infant is an accurate     measurement of temperature in this age group.   "
222168|NCT00762502|"     To evaluate two toric contact lenses on the ocular physiology of existing contact lens     wearers when used in an extended wear modality of days/six nights.   "
222169|NCT00762515|"     The objective is to compare two commerical oral products for the treatment of gingivitis.   "
222170|NCT00762528|"     Plaque induced gingivitis   "
222171|NCT00762541|"     The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in     the treatment of moderate to high myopia (nearsightedness), when used as part of the Laser In     Situ Keratomileusis (LASIK) procedure.   "
222172|NCT00762554|"     Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion     of fentanyl for the first 48 hours after a cesarean section.   "
222173|NCT00762567|"     To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children,     ages 2 to <12 years, and adolescents, ages 12 to <18 years.   "
222174|NCT00762580|"     The goal of this study is to find which patients will improve with the nonsurgical treatment     of physical therapy for the treatment of rotator cuff tears.   "
222175|NCT00762593|"     To compare the effectiveness of a transvaginal electrical stimulation by a home use     programmable device to a placebo device for urinary incontinence in women   "
222176|NCT00762606|"     To compare the health economic parameter and clinical outcome of Phacoemulsification with     small incision cataract surgery (SICS)   "
222177|NCT00762619|"     The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants   "
222178|NCT00762632|"     This is a nonrandomized, open-label study to evaluate the efficacy and safety of combination     treatment of Nilotinib and RAD001 in the treatment of c-kit + AML. Patients refractory to     standard chemotherapy or not eligible to standard chemotherapy can be included. Patients will     be treated with 400 mg Nilotinib bid (total daily dose 800 mg). RAD001 will be added after a     treatment duration of 1 week in a dosage of 2,5 mg/day. Treatment duration will be 25 weeks.   "
222179|NCT00762645|"     The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering     efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in     patients with chronic angle-closure glaucoma (CACG).   "
222180|NCT00762658|"     To investigate dose-response relationship, antipsoriatic efficacy and safety of different     concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris   "
222203|NCT00762970|"     This study is to investigate whether novel soft contact lens optical designs can slow myopia     progression.   "
222191|NCT00762801|"     RLIP76 (Ral binding protein1) is a 76 kDa splice variant protein encoded by the human gene     (RALBP1, 18p11.22). It is a multifunctional modular protein found ubiquitously from     Drosophila to humans, in cells ranging from red blood cells to endothelial cells of the     brain. Its expression more predominant in breast, heart, liver and less so in colon and brain     parenchyma.   "
222192|NCT00762814|"     Some individuals with Parkinson disease experience freezing during walking which results in     their inability to move their feet. They often have difficulty starting to move once they     have stopped. Freezing often results in loss of balance and falling. Oral medications for     Parkinson disease aren't as effective in treating freezing as it is in reducing other     symptoms. Another treatment for freezing is instruction in walking using visual targets or     auditory cues (thinking of a rhythm or beat). These cues can be initially effective for some     individuals, but the effects do not last. Other types of cues have not been studied. We want     to examine the effects of two other cues, tactile (touch) or motor (muscle contraction), on     the effects of freezing.   "
222193|NCT00762840|"     The study is designed to test the hypothesis that there is a difference in healing kinetics     and healing rate between teeth treated by conventional endodontic procedure alone and those     in which such procedure was supplemented with the Apexum Ablator protocol   "
222194|NCT00762853|"     The objective is to develop a method to determine active ingredient uptake in oral care     products.   "
222195|NCT00762866|"     The purpose of this project is to obtain DNA, brain imaging data, other biological samples     (e.g., urine, serum), and a comprehensive clinical assessment on patients with schizophrenia     and other psychotic disorders, bipolar disorder, major depression, and normal volunteer     controls. Understanding the physical and genetic factors related to these disorders will help     us make progress in fitting treatments to an individual's needs. Participants will take part     in a detailed clinical assessment, two blood draws, and an MRI scan over two visits.     Participants will also be asked to provide urine and saliva samples.   "
222196|NCT00762879|"     The purpose of this study is to compare healthy children to children who have a chronic     illness called Juvenile Idiopathic Arthritis (JIA). JIA is a childhood disease that causes     swollen joints that are often stiff and painful. JIA affects about 1 in 1,000 children age 16     and younger.   "
222197|NCT00762892|"     This is a pilot that will evaluate two regimens for treating HIV infected patients that     haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial     infarction and antiretroviral therapy used may contribute to this. We will evaluate     virological, immunological and cardiovascular effects of two HIV treatment regimens.   "
222198|NCT00762905|"     To evaluate the effectiveness, safety, and utility of LiquiBand Laparoscopic™ in relation to     a currently approved active control product (High Viscosity DermaBond). Specifically, the     study is powered to demonstrate that LiquiBand Laparoscopic™ is not inferior to DermaBond in     the rates of infection, dehiscence, cosmesis and apposition of the skin.   "
222199|NCT00762918|"     Vitamin D deficiency is common in cystic fibrosis. Vitamin D deficiency frequently persists     despite aggressive treatment with ergocalciferol, a vitamin D preparation also known as     vitamin D2. Cholecalciferol, a vitamin D preparation also known as vitamin D3,may work better     to increase vitamin D levels.      Vitamin D is important for absorption of calcium from the diet and bone health. Vitamin D     more recently has been found to play a role in regulating the normal inflammatory process.     Since cystic fibrosis is a state of excessive inflammation, vitamin D may be playing a role     in cystic fibrosis.      We hypothesize: cholecalciferol will work better to increase vitamin D levels in patients     iwth cystic fibrosis and that it will have an effect on markers of inflammation.   "
222200|NCT00762931|"     The goal of this study is to validate design for the Resolve™ Stimulator and Proximity     Electrode and the associated procedure to quickly and safely place an electrode into the     neck, in the vicinity of the vagus nerve by a physician in either the Emergency Department or     other appropriate hospital inpatient setting (e.g., ICU). The secondary goal is to confirm     that the electrical signal being delivered via this electrode rapidly counters     bronchoconstriction and improves airway flow.   "
222201|NCT00762944|"     Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and     Effectiveness Data   "
222202|NCT00762957|"     The purpose of this study is to evaluate the safety and efficacy of TAK-559, once daily (QD),     taken in combination with metformin in treating subjects with type 2 diabetes mellitus   "
222204|NCT00762983|"     The purpose of this study is to collect information on unexpected adverse reactions (ADRs),     how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin     (loratadine) when used in children. Patients will be observed while they are taking Claritin,     and ADRs and symptom scores will be recorded. At the end of treatment, improvement in     symptoms will be recorded.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
222205|NCT00762996|"     The objective of this study is to evaluate the clinical performance of two daily disposable     contact lenses.   "
222206|NCT00763009|"     The primary objective of this study is to understand why different people respond differently     to the medication Persantine. The effects of Persantine will be evaluated by performing     echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart     in patients undergoing a clinically indicated percutaneous coronary intervention.   "
222207|NCT00763022|"     The purpose of this study was to determine the safety and efficacy of TAK-559, once daily     (QD), in Type 2 Diabetes subjects.   "
222208|NCT00763035|"     The goal of this research is to determine the utility of Regadenoson (Lexiscan)for use as an     imaging agent with cardiac MR. If found useful, it will help us establish a protocol for     regadenoson stress MR perfusion (Regadenoson stress test with cardiac MR).The investigators     will compare regadenoson with dobutamine so each participant will undergo two studies. A     cardiac MR stress test with regadenoson and with dobutamine. The investigators participants     will include patients with history of COPD and Asthma, so it will also help us determine     feasibility of Regadenoson in these patient's subgroups.   "
222209|NCT00763048|"     To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from     gingivitis and/or periodontitis.   "
222211|NCT00763074|"     The purpose of this study was to evaluate the effects of 12 weeks' increased daily physical     activity versus diet restriction on regional fat distribution, insulin sensitivity and     adipokines including retinol binding protein-4 (RBP-4), leptin, adiponectin, and a new     marker, adiponectin to leptin ratio (AL ratio), in type 2 diabetic women.   "
222212|NCT00763087|"     The purpose of this study is to determine if people with Diabetes Mellitus and peripheral     neuropathy can increase their activity (i.e. walking or stationary biking) and leg strength     without having an increase in foot problems compared to a group of people with diabetes and     peripheral neuropathy that do no exercise.      Our hypothesis is that the weight-bearing exercise group will achieve greater increases in     weight-bearing activity (i.e., increased steps/day and cumulative load) and leg strength     compared to the non-weight bearing exercise group and the non-exercising control group; and     there will be no clinically meaningful difference in incidence or indicators of foot lesions     between groups.   "
222213|NCT00763100|"     There are three main objectives, centering on those patients targeted for surveillance     imaging. The first objective is to compare image quality and specificity of breast     tomosynthesis and conventional 2D mammography in a BIRADS 3 diagnostic population. The second     objective is to compare image quality and ability to determine post-surgical and     post-radiation changes from recurrence in a post-cancer subset of a BIRADS 3 population     having undergone conservation therapy (lumpectomy with or without radiation. The final     objective is to compare image quality and the ability to determine chemoresponsiveness in a     post-cancer subset of a BIRADS 3 population, who are undergoing neoadjuvant chemotherapy.   "
222214|NCT00763113|"     Main Objectives are: Test Difference in terms of early ROM between Vanguard FB CR and     Vanguard FB PS. Knees; Demonstrate the comparable ROM of high flex PS to CR.   "
222215|NCT00763126|"     It is unclear the effect of a spouse's presence on the partureint's and the spouse's stress     level during the performance of epidural analgesia during labor.      Couples will be randomized to two groups: one group where the spouse is present during the     performance of epidural analgesia and the second where the spouse is not present.      Before and after epidural anlgesia, both the spouse and parturient will be have their blood     pressure and pulse checked. In addition, both will have their salivary amylase measured.      Salivary amylase is an enzyme whic has been foud to correlate directly with stress levels. To     check this enzyme, a sample of saliva is given.   "
222216|NCT00763139|"     Rheumatoid arthritis (RA) is a form of arthritis that causes pain, swelling, stiffness, and     loss of function in the joints. Over time, joint deformity, joint destruction, and loss of     function can occur. Current treatment aims to improve symptoms, but there is no cure for the     disease. Pioglitazone is drug that is effective in treating people with diabetes. This study     will determine whether pioglitazone can also be used to effectively treat people with RA.   "
222217|NCT00763152|"     This is an observational study to collect placement and tracking data for patients who have     the Calypso transponders implanted into the peri-prostatic tissue.   "
222218|NCT00763165|"     To access the influence of triclosan dentifrice on the progression of periodontal disease in     patients with coronary heart disease.   "
222234|NCT00763386|"     The purpose of this study is to test for significant differences in functional outcomes     obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is     predicted that an increase in postoperative range of motion will be experienced by patients     treated with the NexGen LPS-Flex knee implant.   "
222245|NCT00763529|"     This is an open-label, randomized, parallel-group clinical study. The primary objective is to     assess the difference in response rate between mometasone furoate cream 0.1% (once daily) vs     fluticasone propionate cream 0.05% (twice daily) by the end of Day 4 and Day 8 in the     management of Indian patients with localized psoriasis.   "
222273|NCT00763906|"     The weaning rate of vasopressors drugs is usually chosen empirically by the clinician in     critically patients. The investigators applied fuzzy logic principles to modify intravenous     norepinephrine infusion rates during norepinephrine infusion in septic patients in order to     reduce the duration of shock. The investigators goal was to reduce the duration of poorly     controlled hemodynamic status.   "
222219|NCT00763178|"     Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment     response to pharmacological interventions has been modest for these patients. Chronic     elevated anxiety and associated psychophysiological parameters including increased heart rate     and alterations in skin conductance are key symptoms of chronic PTSD. Selective serotonin     reuptake inhibitors (SRIs) are considered treatment of first choice for these patients,     however a substantial portion of patients treated with SRIs do not respond sufficiently.     Therefore, there is a need to establish novel and effective treatment strategies for these     patients. Recently, duloxetine has received considerable attention since it was shown in     multiple controlled trials to be an effective treatment for people with major depressive     disorder (MDD), a condition which is often co-morbid with PTSD. In chronic PTSD, the     psychophysiological responses at baseline and in response to treatment with duloxetine have     been inadequately studied and may provide novel insight into antidepressant and anxiolytic     mechanisms of this compound.      Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of duloxetine in patients     with chronic PTSD.      Secondary Aim 2: Evaluate the effects of duloxetine on fear conditioned psychophysiological     responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat     interval) at baseline and after 8 weeks of naturalistic treatment in chronic PTSD patients.   "
222220|NCT00763191|"     The specific aim of this study is to compare ocular movements abnormalities between males     with pre-mutation on FRM1 gene (symptomatic or asymptomatic on the motor plan and/or on the     cognitive plan), males without the pre-mutation and males with multi-systematized atrophy, in     order to identify the neuronal structures implicated in this pathology.   "
222221|NCT00763204|"     The purpose of this study is to investigate dose-response relationship, antipsoriatic     efficacy and safety of different concentrations of topical formulations with AN2728 in     subjects with psoriasis vulgaris.   "
222222|NCT00763217|"     In a previous suty, we have demonstrated that prior transient ischemic attack, treatment     lipid-lowering drug or physical activity are associated to a better outcome of stroke. The     aim of the study is to understand the mechanisms of this preventive neuroprotection by     establishing link between biomarkers and preventive and neuroprotective measures.To answer to     the question, we conduct a cohort study of stroke patients.   "
222223|NCT00763230|"     Depression is a common illness with an approximate lifetime prevalence of 17 %, conferring a     large burden of disease in the community, often due to inadequate treatment. Thus there is     interest in the therapeutic potential of non invasive, novel forms of brain stimulation, such     as transcranial direct current stimulation (tDCS). Two small studies have been published in     the last two years indicating that 20 minutes of either 1 or 2mA tDCS over 5 or 10 sessions     is safe, painless and well tolerated. The investigators' own pilot data (N=30) also suggests     the technique has antidepressant effects and is safe (5-10 sessions of tDCS at 1 mA).      This study will extend previous findings, testing a more definitive tDCS approach (also left     prefrontal anodal stimulation) with a longer treatment course (15 sessions), at 2 mA (which     has been found to be safe and more effective than 1 mA in cognitive studies), and in a larger     sample (N=68), using a placebo-controlled design.      It is hypothesised that active tDCS (15 sessions) will have greater efficacy than sham     treatment (15 sessions) in reducing the severity of depressive symptoms in patients in an     episode of major depression. A second hypothesis is that 15 sessions of tDCS will not cause     any significant adverse effects or cause decline in neuropsychological functioning in     comparison to a sham control.   "
222224|NCT00763243|"     This study is an investigation of the effect of a computer-based working memory training     program on memory and language processing in at-risk children (e.g., those with working     memory weaknesses) who have received cochlear implants.   "
222225|NCT00763256|"     To test effectiveness of dentifrice in maintaining periodontal health.   "
222226|NCT00763269|"     Hypersensitivity   "
222227|NCT00763282|"     Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal     cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and     most persons with SCI will have at least one serious PrU during their lifetime. VA costs of     treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in     FY10 was just under $400 million.   "
222228|NCT00763295|"     HIV infection highly increases the risk of progression of latent tuberculosis (TB) to active     disease that therapy is recommended for all PPD-positive, HIV-infected patients, regardless     of age. Sensitivity of the PPD testing is, however, dependent on a normal T cell function.      Therefore, an accurate and reliable method for detection of latent tuberculosis in patients     with HIV is urgently needed.      This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay,     T-SPOT.TB,for detection of TB in HIV-infected individuals.   "
222229|NCT00763308|"     Heart disease is the leading cause of death in the United States, accounting for     approximately 700,000 deaths a year. Heart disease can take many forms, including heart     attacks, coronary artery disease, aneurysms, high blood pressure, and strokes. However,     people can change things in their life to reduce the risk of getting heart disease. This     study will first create an Internet-based program to help teach people about reducing heart     disease risk and will then test the program in a workplace setting.   "
222230|NCT00763321|"     The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of     ABT-712, compared to placebo, administered over a 4-week period in participants with moderate     to severe mechanical chronic low back pain (CLBP).   "
222231|NCT00763347|"     The purpose of this study is to determine the efficacy and safety of SYR-619, once daily     (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with     diet and exercise, or by taking metformin.   "
222232|NCT00763360|"     The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD)     compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the     ability to maintain anterior chamber space, in routine cataract surgery.   "
222233|NCT00763373|"     Observation of the use of intravenous antibiotics in medical clinic of Sorlandet Hospital,     Norway. Suggestions of criteria for the switch from intravenous to oral administration of     antibiotics. Implementation of the criteria and new registration of the use of intravenous     antibiotics. Comparison of the amount of the iv-administration before and after the     intervention.   "
222235|NCT00763399|"     The balance between immunogenic and tolerogenic activities in human immune system strongly     depends on microflora-induced pro-and anti-inflammatory activities. Probiotics are important     components of microflora. The interactions of the different strains of probiotics and the     cells of immune system are largely unknown.      There are many mechanisms by which probiotics enhance intestinal health, including     stimulation of immunity, competition for limited nutrients, inhibition of epithelial and     mucosal adherence, inhibition of epithelial invasion and production of antimicrobial     substances.      Fecal immunoglobulin A(IgA), lactoferrin and calprotectin were determined by enzyme-linked     immunosorbent assay(ELISA) and compared in different groups. Other clinical symptoms or     signs, including fever, vomiting, diarrhea, abdominal pain, bloating abdomen, daily intake     and body weight were also assessed.      The first aim of our study is to evaluate the role of probiotics and their preparation     products on the restoration of intestinal bacterial population. The second aim of our study     is determining the immunomodulating effects or anti-inflammatory effects of probiotics on the     host (human being). We try to seek to gain an advanced understanding of probiotics versus     intestinal microorganism and host interactions, as well as mucosal immune responses to     probiotics in the intestine.   "
222236|NCT00763412|"     The purpose of this study is to provide the necessary data and experience to design a larger,     full scale clinical trial to determine if a certain medicine (repaglinide), which increases     the amount of insulin secreted by the pancreas, can improve the nutritional status and     pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by     improving blood glucose control. The investigators are also trying to determine the     relationship between systemic inflammatory factors and glucose impairment.   "
222237|NCT00763425|"     The aim of this study is to compare cold snare polypectomy and conventional polypectomy for     the removal and retrieval of small colorectal polyps.      Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than     conventional polypectomy.   "
222238|NCT00763438|"     The purpose of this study is to permit the patients with schizophrenia who received     Sertindole during a previous randomised trial, study 99824, to continue with this treatment.   "
232454|NCT00895921|"     This study will examine the effects of two different antipsychotic medications on control of     blood sugar in people who are at risk of diabetes but mentally healthy.   "
222239|NCT00763451|"     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in     comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of     treatment, followed by an extension.      The primary objective is to assess the effects of lixisenatide when added to metformin on     glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two     steps dose titration regimen at Week 24.      Secondary objectives are to assess the effects of lixisenatide when added to metformin on     glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a     one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or     less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety,     tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.   "
222240|NCT00763464|"     Aim of this study is the determination of a valid procedure for ischemia diagnositc in     postmenopausal women.   "
222241|NCT00763477|"     Background to ghrelin Ghrelin is a naturally occurring hormone found in the blood which     stimulates appetite. In healthy individuals, levels of ghrelin are high before a meal and     falls afterwards. Previous studies have shown that giving ghrelin (by injection) to thin     patients with renal failure and cancer increases their food intake. Furthermore, addition of     ghrelin may also reduce inflammation within the body. Cystic Fibrosis (CF) is a genetic     disease which frequently results in recurrent lung infections (leading to progressive     inflammatory lung damage) and low body weight. Low body weight in CF is associated with     increased lung infections, rapidly worsening lung function and a shortened life expectancy.      The researchers postulate that administration of extra ghrelin to CF patients with low body     weight may increase food intake and reduce lung inflammation. If successful, this study might     identify ghrelin as a potential therapy for CF patients to improve nutrition, decrease lung     inflammation and thereby improve survival.   "
222242|NCT00763490|"     This pilot research study is to investigate the safety and effectiveness of stem cell     transplantation to treat blood-related (hematopoietic) cancers, using stem cells collected     from two different, umbilical cord blood donors. Subjects in this study are receiving a stem     cell transplant because other treatments have failed or their disease is unlikely to respond     to other treatment options.      Blood-related cancers can be treated and sometimes cured with very high doses of chemotherapy     and radiation therapy, given to kill the cancer cells; however, these treatments can prove     unsuccessful and can harm normal cells in the bone marrow or a patient's disease may be     unlikely to respond to these treatment options.      Hematopoietic stem cells transplantation (HSCT) is a potential cure, but opportunities to     perform HSCT are limited by donor availability. Only 20-30% of patients may have matched     family donors. In some cases, a mismatched family donor may be suitable. For patients needing     a transplant who do not have a suitably matched family donor, blood stem cells from matched     unrelated donors can be used. The length of time required to identify a matched unrelated     donor presents another obstacle for patients waiting to receive an HSCT.      Blood stem cells are found in umbilical cord blood (UCB), which is blood left over in the     placenta (afterbirth) after a baby is born. Usually this blood is discarded with the     placenta, but over the past 15 years, we have learned how to collect and freeze cord blood     cells to be used for transplants at a later time. A cord blood unit is the cord blood cells     collected and stored from a single placenta. More than 6,500 umbilical cord blood stem cell     transplants have been done worldwide, mostly in children with leukemia. One important factor     affecting the success of a cord blood transplant is the cell dose (number of stem cells in     the cord blood unit / recipient's weight). Patients who receive a high cell dose (> 2.5 x 107     cells/kilogram) have better marrow recovery and a higher rate of survival than those who     receive a lower cell dose.      In an attempt to make UCB transplantation possible for bigger children, adolescents and     adults, researchers have tried giving two cord blood units on the same day for their     transplant, one after the other. The data from more than 150 double cord blood transplants     in adults suggest that the double cord blood transplants may allow bone marrow recovery and     survival in patients who do not have a single cord blood unit with enough cells for     successful transplantation.      This is a pilot study to research the safety and effectiveness of using two UCB units in     adult and pediatric UCB transplantation when combined with a conditioning regimen called     Flu/Bu4/TLI (consisting of fludarabine, busulfan and total lymphoid irradiation).   "
222243|NCT00763503|"     This is a multicenter, open-label study to assess systemic plasma levels of calcitriol,     calcium homeostasis and safety in adults with plaque-type psoriasis under conditions of     maximized use of CD 2027 3µg/g oily spray twice daily (6 g daily), applied to 20% of BSA for     3 weeks.      There are a total of six visits: Pre-treatment period (Day -15, Day -8 and Day -1) and     Treatment period (Day 1/ Baseline, Day 15 and Day 22).   "
222244|NCT00763516|"     The purpose of this study is to find out what effects, good and/or bad, proton radiation     combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will     look at the side effects from the treatment and the quality of your life in relation to pain.     It will also look at how the tumor responds to the combination of treatment with radiation,     chemotherapy and surgery.   "
222339|NCT00755495|"     The purpose of this study is to determine the efficacy of ramelteon, once daily (QD),     combined with doxepin in treating subjects with insomnia.   "
222246|NCT00763542|"     This study is a randomized controlled trial comparing two treatments for patients with     comorbid substance use disorder (SUD) and post-traumatic stress disorder (PTSD) conducted     within two different routine clinical settings for the treatment of SUD, namely (a) a     day-care and inpatient setting and (b) an outpatient setting. Participants will be randomly     assigned to either (1) a combination of cognitive-behavioral treatment (CBT) for SUD and     trauma-focused structured writing therapy, or (2) CBT for SUD alone. Randomization will take     place separately for each setting. It is expected that the combined treatment is     significantly more effective in reducing symptoms of SUD as well as PTSD than CBT for SUD     alone. Outcome measures will be assessed at pre-treatment, post-treatment as well as 3     months, 6 months and 12 months follow-up.   "
222247|NCT00763555|"     This is a multicenter, randomized, vehicle-controlled, double-blind parallel group study to     evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in     subjects with plaque-type psoriasis.   "
222248|NCT00763568|"     The purpose of this study is to determine if taking nitazoxanide alone for 4 weeks followed     by 36 weeks of nitazoxanide plus peginterferon is superior to peginterferon plus ribavirin     (standard of care) for 48 weeks.   "
222249|NCT00763581|"     This study will attempt to increase understanding of why bipolar disorder patients do or do     not take their medications by conducting in-depth interviews with them.   "
222250|NCT00763594|"     The study investigates the relative efficacy of Interpersonal Psychotherapy and Brief     Relational Therapy for Major Depressive Disorder. The primary hypothesis is that there will     be no mean difference in efficacy between treatments, but that Brief Relational Therapy will     be more efficacious for more self-critical patients and Interpersonal Psychotherapy will be     more efficacious for less self-critical patients.   "
222251|NCT00763607|"     Aim of the study is to evaluated the role of IGF1R and p95HER2 on prognosis in radically     resected non small cell lung cancer patients      The primary objective is to correlate the expression of IGF1R and p95HER2 with survival.   "
222252|NCT00763620|"     The aim of this study is to develop a safe and effective technique to take sample for lower     respiratory tract cultures easy to perform in conditions of acute respiratory failure and     spontaneous ventilation for patients admitted in intensive care unit for acute infectious     pneumonia and non intubated. The investigators perform sample collection with a mini     bronchoalveolar lavage catheter introduced by nasotracheal way through a suction catheter.     The purpose of the study is to assess the microbiological diagnostic capacity of this new     technique.   "
222253|NCT00763633|"     The purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is     effective in nausea and vomiting of pregnancy.   "
222254|NCT00763646|"     The primary purpose of the study is to determine the impact of chemotherapy on the ability of     your surgeon to completely remove the cancer as well as the impact on your survival.     Furthermore the investigators will be assessing the side effects of this chemotherapy     strategy. Finally the investigators will determine the ability of specialized imaging     technology (PET scan) to document and predict the response of the tumor to this chemotherapy.      Standard therapy for patients with your condition usually consists of surgery (removal of the     tumor) followed by combination chemotherapy and radiotherapy. More recently, standard options     available to patients with cancer of the stomach or lower esophagus have been expanded to     include chemotherapy without radiotherapy prior to and following surgery. While it is     believed that chemotherapy prior to surgery is a good option for patients with stomach, it is     not known what is the optimal chemotherapy regimen to offer patients prior to surgery to     improve the likelihood of cure while limiting side-effects to patients.   "
222255|NCT00763659|"     The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the     supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the     optical density (OD) of macular pigment in patients with non- exudative age related     maculopathy.      Furthermore, it is to be examined whether changes of the optical density are different     dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD     patients are studied. The measurement of optical density of macular pigment uses the 1-     wavelength reflection method recording reflection images at 460 nm by a fundus camera. The     patients are investigated at baseline and are followed up over one year in four more visits.     In addition to the OD- measurement each examination includes standardized visual acuity test     (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and     autofluorescence) and a blood sample.   "
222256|NCT00763672|"     The purpose of this study is to determine whether close monitoring of patients with a high     sFlt1 plasma level between 25 and 28 weeks of gestation (i.e. at high risk of subsequent     preeclampsia) improves maternal and fetal outcomes. The investigator hypothesize that 1/     early screening for preeclampsia by plasmatic sFlt1 will reduce maternal and fetal mortality     and morbidity and 2/ a simple urinary PlGF screening will be effective.   "
222257|NCT00763685|"     Primary Hypothesis:      1. The analgesic effect of etoricoxib 120 mg administered 1 hour preoperatively is greater     than that of placebo in the treatment of postoperative pain.   "
222258|NCT00763698|"     This is a prospective, multi-center non-randomized clinical study to evaluate the safety and     efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient     population. The study will be conducted at a maximum of 20 investigational centers located in     the United States and a total of 68 patients will be enrolled.   "
222259|NCT00763711|"     The purpose of this study is to evaluate the use of the Needle Guide as an assist in properly     guiding an injection needle into the appropriate tissue plane during an injectable bulking     agent procedure in women using a FDA approved injectable bulking agent. The injectable     bulking agent will be Durasphere EXP.   "
222260|NCT00763724|"     The primary objective of the study is to estimate the incidence of suicide attempts resulting     in a medical encounter or hospitalization in seven propensity matched cohorts of subjects:     patients treated with duloxetine for depression, patients treated with one of three other     antidepressants or antidepressant classes (venlafaxine, SSRIs, or TCAs) for depression,     patients treated with multiple antidepressants for depression (either concurrently or     consecutively), depressed patients with no pharmacologic treatment, and a non-depressed     general population sample.   "
222340|NCT00755508|"     The purpose of this study is to determine the efficacy and safety of ramelteon, once daily     (QD), taken in combination with Gabapentin for treating insomnia.   "
222261|NCT00763737|"     Isolated Congenital Diaphragmatic Hernia (CDH) can be diagnosed in the prenatal period, and     remains associated with an 30 % chance of perinatal death and morbidity mainly because of     pulmonary hypoplasia and pulmonary hypertension. In addition, in the survivors there is a     high rate of morbidity with evidence of bronchopulmonary dysplasia in more than 70% of cases.     The risk for these can be predicted prenatally by the ultrasonographic measurement of the     observed/expected lung area to head circumference ratio (O/E LHR) which is a measure of     pulmonary hypoplasia. Also position of the liver is predictive of outcome.      The proposing consortium has developed a prenatal therapeutic approach, which consists of     percutaneous fetoscopic endoluminal tracheal occlusion (FETO) with subsequent removal of the     balloon . Both procedures are performed percutaneously, there is now experience with more     than 150 cases and it has been shown to be safe for the mother. We have witnessed an     improvement of survival in fetuses with a predicted chance of survival of less than 30%     (referred to as fetuses with severe pulmonary hypoplasia; O/E LHR <25% and liver herniation)     to 55% on average. Also there is an apparent reduction in morbidity with the rate of     bronchopulmonary dysplasia decreasing from the estimated rate of more than 70% to less than     40% in the same severity group .      Further we have shown that results of FETO are predicted by LHR measurement prior to the     procedure , so that better results can be expected in fetuses with larger lung size .     Therefore we now aim to offer FETO to fetuses with moderate CDH (=O/E LHR 25-34.9%,     irrespective of the liver position as well as O/E LHR 35-44.9% with intrathoracic herniation     of the liver). When managed expectantly the estimated rate of postnatal survival is 60% or     lower and the rate of broncho-pulmonary dysplasia in survivors is 33% or higher.      This trial will test whether temporary fetoscopic tracheal occlusion rather than expectant     management during pregnancy, both followed by standardized postnatal management, decreases     the occurrence of bronchopulmonary dysplasia or increases survival. The balloon will be     placed between 30 and 32+6 weeks, and will be removed between 34 and 34+6 weeks.   "
222262|NCT00763750|"     The purpose of this study is to determine the antitumor activity of PPX in combination with     temozolomide and radiation for patients with newly diagnosed brain tumors.   "
222279|NCT00763984|"     The primary goal of this project is to determine the efficacy of an antenatal Bladder Health     class to prevent UI in a diverse sample of African American, Caucasian, and Hispanic     childbearing women. The determination of efficacy will be made at 12-months post index birth,     a time point that is a traditional benchmark of recovery from childbirth, using UI     incidence/severity as the primary outcome.   "
222453|NCT00757042|"     This study is a phase 1 single dose escalation study of AMG 157 in healthy subjects and     subjects with moderate to severe atopic dermatitis. The purpose of the study is to evaluate     the safety, tolerability and pharmacokinetics of AMG 157.   "
222263|NCT00763763|"     Patients not previously exposed to imatinib and with resistant or refractory Ph+ ALL,     lymphoid blast crisis chronic myelogenous leukaemia (LBC CML) or with de novo Ph+ ALL and     aged over 55y were eligible in the study. The DIV regimen consisted in one IV injection of     vincristine 2 mg combined with 2 days of dexamethasone 40 mg PO repeated weekly for 4 weeks     as induction and then monthly for 4 months as consolidation. Imatinib was administered at 800     mg per day during the induction period and at 600 mg/d continuously during consolidation.     Patients in CR not eligible for HSCT were allocated to maintenance therapy consisting in     weekly SC injection of Pegasys 45 µg and continuous administration of imatinib 400 mg per day     for 2 years.   "
222264|NCT00763776|"     To identify the most efficient parenchyma transection technique for cirrhotic liver resection     between the clamp crushing technique and the ultrasonic dissector.      Primary endpoint is intra-operative blood loss during liver transection (ml). Expected     results and implications: If one of the technique is better than the other, surgical teams     could prefer it to minimize the morbidity of liver resection in cirrhotic patients.   "
222265|NCT00763789|"     The purpose of this study is to compare a new method: the combination of conscious sedation     with remifentanil (a shortlasting opioid drug) and local anaesthesia, with the traditional     general anaesthesia for hysteroscopic surgery. The primary outcomes are: the time spent in     the operation room, the time to full mobilisation postoperatively and the time to complete     recovery postoperatively and the time to discharge. Secondary outcome: patient satisfaction.   "
222266|NCT00763802|"     This project aims to validate a predictive model of diabetic retinopathy progression to     clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The     Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and     LDL levels, established on a set of 52 diabetic patients, will be tested on a population of     400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at     6-month interval (V0 and V6) to classify each patient into one of the 3 previously     established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of     end-points, achieved by the patients, are expected to validate our predictive model.   "
222267|NCT00763815|"     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in     comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over     a period of 24 weeks of treatment, followed by an extension.      The primary objective is to assess the effects of lixisenatide when added to pioglitazone on     glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at     Week 24.      Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on     the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to     6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic     model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to     assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody     development.   "
222268|NCT00763828|"     The hypothesis of this study is that consciously sedated patients suffering from ST-elevation     myocardial infarction can be rapidly and safely cooled to a state of therapeutic hypothermia     (32 to 34 degrees C) using the LRS ThermoSuit System prior to percutaneous coronary     intervention.   "
222269|NCT00763841|"     Transcranial magnetic stimulation (TMS) involves the use of magnetic fields to non-invasively     stimulate the brain. Studies overseas have suggested this may be an effective and safe     treatment for auditory hallucinations in patients with schizophrenia. This is a     sham-controlled, double-blind trial of TMS stimulation for the treatment of auditory     hallucinations in patients with schizophrenia.   "
222270|NCT00763867|"     Diastolic heart failure (DHF), which affects older individuals and women at a     disproportionate rate, is a condition that can lead to shortness of breath and fluid build-up     in the lungs. This study will evaluate the effectiveness of the medication sildenafil at     improving exercise ability and health outcomes in people with DHF.   "
222271|NCT00763880|"     The purpose of our study is to determine if the use of a hematoma block together with     intravenous sedation and analgesia is an effective means of managing forearm fractures in the     Emergency Department. To determine this, we have designed a randomized, double-blind, placebo     controlled trial of hematoma block versus saline for the manipulation of forearm fractures     under conscious sedation with ketamine and midazolam. Our hypotheses are two-fold: First, the     use of a hematoma block together with conscious sedation will allow for improved pain     control. Second, the use of a hematoma block together with conscious sedation will allow us     to use less sedation, therefore promoting faster recovery from sedation and more efficient     patient turnover in the Emergency Department.   "
222272|NCT00763893|"     The purpose of this study is to evaluate if losartan limits aortic dilatation in patients     with Marfan syndrome.   "
224561|NCT00797953|"     The purpose of this study is to determine the anti-angina effect and dose response of T89, a     2-herb botanical drug product, in patients with chronic stable angina pectoris in the United     States.   "
222274|NCT00763919|"     In this study, patients with bipolar disorder who do not take their medications as prescribed     will receive specialized education and therapy treatment to determine whether the specialized     treatment is effective in helping patients to take their medications consistently.   "
222275|NCT00763932|"     This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in     patients with infantile-onset Pompe disease who were previously treated with rhGAA derived     from the Synpac cell line   "
222276|NCT00763945|"     The Aachener Digitale Myokardinfarkt Register (ADMIRE) is a prospektive registry study which     was designed in order to obtain data of patients with acute coronary syndrome and herewith     control and optimize guideline conform therapy of these patients.   "
222277|NCT00763958|"     This study is a feasibility and acceptability study assessing whether providing buprenorphine     for women under criminal justice supervision leaving a controlled environment and returning     to the community would prevent opioid relapse and reduce HIV risk behaviors.   "
222278|NCT00763971|"     The main aim of this study is to see if giving LDX to children and adolescents aged 6-17     years with ADHD decreases symptoms of ADHD.   "
224043|NCT00784940|"     To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX     plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving     trial therapy.   "
222280|NCT00763997|"     Dipyrone is suggested to inhibit the platelet aggregation comparable to th effect of     traditional analgetic substances like Ibuprofen. To verify this hypothesis the investigators     conducted the study in comparing patients undergoing traumatologic, visceral or plastic     surgical procedures. The investigators randomized them to four groups receiving common     analgetic doses of either dipyrone, acetaminophen (paracetamol) or valdecoxib/parecoxib. The     investigators took blood samples before initiation of the study drug, 1h, 4hs and 24hs after     first intake. The investigators compared the aggregation via aggregometry of platelet rich     plasma.   "
222281|NCT00764010|"     The study was actuated to evaluate the effects of a 3-year intervention with diet and/or very     long chain omega-3 (VLC n-3 PUFA), in a randomized 2x2 factorial design on the progression of     atherosclerosis in a high risk population. A total of 563 elderly men were included and     randomized to receive usual care and VLC n-3 placebo capsules (control group), dietary advice     and VLC n-3 placebo capsules, usual care and VLC n-3 capsules, and finally both VLC n-3     capsules and dietary advice.      The evaluation of atherosclerosis were i) ultrasound measurement of carotid intima media     thickening ii) pulse wave propagation time iii) circulating biomarkers of atherosclerosis.   "
222282|NCT00764023|"     The intent of this protocol is to salvage human-related material that is normally destined     for destruction, so it can be used in infection-related scientific studies. This clinical     material can be studied in order to better understand the molecular, cellular, or ecological     components of the infected or potentially infected tissue or device.   "
222283|NCT00764036|"     The purpose of this study is to evaluation the tolerability of an add-on therapy with     artesunate with a duration of 4 weeks in patients with advanced breast cancer.   "
222284|NCT00764049|"     The aim of this study is to determine whether a simplified device of albumin dialysis also     has beneficial effects.   "
222285|NCT00764062|"     Antibiotic resistance is a worldwide problem closely linked to antibiotic consumption. To     limit the risk to select resistant bacteria, the rules of prescription are to use high doses     and short durations of treatment. The purpose of this study was to evaluate the interest to     reduce amoxicillin treatment from 7 days to 3 days, in cases of odontogenic infection     requiring the extraction of the tooth associated with amoxicillin monotherapy. The 3-day     treatment will be compared to the classical 7-day treatment for clinical efficacy (pain,     wound healing) and impact on the susceptibility of oral streptococci to amoxicillin.   "
222286|NCT00764075|"     In this open, prospective, randomized, parallel group, German-American, two-center, Phase I     study the standard-approach CRT-implantation will be compared to a guided CRT-implantation     after determining the site of latest contraction and placement of the electrode as close as     possible to this site, using a 5-step-scheme of imaging methods determining the site of     latest contraction prior to implantation.   "
222287|NCT00764088|"     To demonstrate the effectiveness or ineffectiveness of novel treating agents or agents used     for compassionate rescue, subjects and their wounds will be analyzed retrospectively and     their non-identifiable information will be compiled in the form of case studies. Subjects who     demonstrated characteristics of interest (e.g. healing) as determined by the PI will be     chosen for case studies.   "
222288|NCT00764101|"     Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training     on attentional bias and on symptoms of Posttraumatic Stress Disorder.   "
222289|NCT00764114|"     Duration of antimicrobial therapy for spondylodiscitis is not standardized; it could vary     from 6 weeks to several months depending on the medical habits. The study hypothesis is that     a 6 weeks antimicrobial therapy is not inferior to a 12 weeks.      We run a prospective multi-centric, non inferiority open label trial, randomised in two     parallel groups.      The main objective is to compare the efficacy of two durations of antibiotherapy, 6 weeks     versus 12 weeks, on the rate of cure in this indication.      The study concerns 400 patients more than 18 years, 70 centres in France are involved.      The duration of the study is 4 years.   "
222290|NCT00764127|"     The purpose of the study is to develop methods to evaluate the eating behavior of     adolescents, including overweight, normal weight, and candidates for adolescent bariatric     surgery.   "
222291|NCT00764140|"     Malignant cells frequently produce many tumor growth factors to autocidal or endocrinal     proliferate growth, metastasis,or angiogenesis about tumor cells. By studying tumor growth     factors in hepatocellular carcinoma, one may know the tumor behavior, its relationship with     clinical manifestation or invasion, and could be used as diagnostic or prognostic tools.This     study aims to study the relationship between tumor growth factors in HCC ant its clinical     relevance.   "
222341|NCT00755521|"     The main of the proposed study is to assess whether the use of the Cox-2 inhibitor Etoricoxib     is beneficial for the use in fibromyalgia. We intend to seek whether this medication may     improve psychiatric and rheumatologic parameters of the disease.   "
222292|NCT00764153|"     An estimated 1.6 million patients sustain a hip fracture every year, about half of these are     intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for     any patient, and the risk of disability, increased dependence and death is substantial. The     main treatment options for displaced femoral neck fractures are internal fixation and     arthroplasty. It is established that there are more complications and reoperations after     internal fixation, and better short term clinical results with arthroplasty, but knowledge     about long term results is lacking.   "
222293|NCT00764166|"     The primary objective was to evaluate the PSA (biochemical) progression-free survival (PFS)     of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or     without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).      The study was powered at 80% to detect a 25% improvement in biochemical PFS for a total     sample size estimated at 252 patients, with a two-sided type I error rate of 5%     (non-parametric methods.   "
222401|NCT00756340|"     The main goals of this Phase I study are to learn about the side effects that may occur when     everolimus and bevacizumab are given to children and young adults and to find the highest     doses of these drugs that can be given together without causing severe side effects.     Bevacizumab will be given into the vein (IV) over 30-90 minutes every two weeks and     everolimus tablets will be given daily by mouth. A cycle of therapy will be four weeks.   "
234120|NCT00912093|"     This study is being conducted to evaluate the efficacy and safety of icatibant compared to     placebo in patients experiencing acute attacks of hereditary angioedema (HAE).   "
222294|NCT00764179|"     Neonates with intra-uterine growth delay represent more than 2% of the 800 000 annual births     in France. Studies have shown that milks enriched with protein allow to accelerate newborns     growth. According to some papers, growth acceleration would have a favourable effect on     psycho-motor development at age of 2 or 3. However, for other authors, this would not lead to     any benefit and even an early hyperproteinic feeding would have bad long term consequences     such as appearance of several diseases in the future adult (overweight, diabetes, arterial     hypertension, renal function alteration).The main objective of this clinical trial is to     check that an hyperproteinic feeding does not lead to any benefit on psycho-motor development     at age of 2, compared with a milk containing same level of protein than milk proposed to     newborns of normal weight. The secondary objectives of our clinical trial are to compare the     effects of these two types of milk on renal function, arterial blood pressure, body     composition, corpulence, food preferences, insulin resistance and intestinal integrity at age     of 2. A sub study will also be realized to analyse the proteic turn over . This sub-study     will be undertaken only with neonates of Nantes Hospital.   "
222295|NCT00764192|"     An impairment of nitric oxide (NO) bioavailability is associated with endothelial dysfunction     and may contribute to the excessive incidence of cardiovascular complication in chronic     haemodialysis (HD) patients. It is not known whether cell-free hemoglobin limits nitric oxide     bioavailability during HD.   "
222296|NCT00764205|"     This study randomizes patients seen by Redmond Medic One into a control arm and a study arm     when they present with acute coronary syndrome and have non-contributory ECG's     (i.e.non-STEMI). The control group is treated normally and delivered to the receiving     hospital. The study group is treated normally as well, however troponin measurements are made     using an i-STAT blood analyzer prior to hospital arrival. The results are presented to the     receiving physician. Door-to-reperfusion time is monitored for both groups.   "
222297|NCT00764218|"     Patients with obstructive sleep apnea syndrome have permanent variations of their hemodynamic     parameters during the night : heart rate, arterial blood pressure, cardiac output. This is     due to the repetition of respiratory events (obstructive apnea and hypopnea) leading to     frequent micro-arousals. These disorders have several consequences : hypertension,     NO-dependent vasodilatation impairment, baroreceptor reflex impairment, insulin resistance     and other cardiovascular impairments.   "
222298|NCT00764231|"     Fatigue is the most common and disabling symptom in acute myeloid leukaemia (AML). Studies in     other cancer patients with fatigue have shown that exercise improves both fatigue and quality     of life (QOL), but there are no such studies in AML. The investigators want to conduct a     pilot study of a home-based exercise program to see if this type of exercise program is     feasible for AML patients, reduces fatigue, and improves QOL. What the investigators learn     from this study will be essential to designing a larger, definitive randomized trial of     exercise in patients with AML.   "
222299|NCT00754975|"     Prospective, multi-center, randomized trial. A maximum of 130 patients will be enrolled, in a     2:1 ratio to receive either the JACTAX LD stent or the TAXUS™ Libertè™ stent to evaluate the     efficacy of the product.   "
222300|NCT00754988|"     This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared     to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled     with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg     once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or     placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment.     After 24 weeks of treatment, patients on active treatment will continue on the same treatment     and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide     20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on     study treatment is 2+ years, and the target sample size is 500+ individuals.   "
222301|NCT00755001|"     This post market study intends to evaluate the safety and the performance of BiHapro Total     Hip System with two types of coatings.   "
222302|NCT00755014|"     Light-to-moderate alcohol consumption has been associated with a reduction of cardiovascular     events, and red wine seems to offer more benefits than any other type of alcoholic beverages.     However, the relationship between red wine consumption and endothelial progenitor cells     (EPCs) remains unclear. The investigators examine whether intake of red wine could enhance     the number or functional capacity of circulating EPCs by upregulation of nitric oxide (NO)     bioavailability.   "
222303|NCT00755027|"     The purpose of this study is to determine whether rasagiline is effective in the treatment of     apathy in patients with Parkinson's disease.   "
222304|NCT00755040|"     RATIONALE: Cyclosporine eye drops may prevent graft-versus-host disease of the eye in     patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow     failure disorder.      PURPOSE: This randomized phase I trial is studying how well cyclosporine eye drops work in     preventing graft-versus-host disease of the eye in patients who have undergone donor stem     cell transplant for hematologic cancer or bone marrow failure disorder.   "
222305|NCT00755053|"     The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not     inferior to the old Canesten formulation (tablet)   "
222342|NCT00755534|"     This phase II study will evaluate which is the best way to administer cetuximab after     recurrence in 1st line irinotecan+bevacizumab based treatment and to obtain results of the     efficacy of the oxaliplatin+cetuximab combination as 2nd line treatment.   "
222306|NCT00755066|"     Evaluation of the effect of fluticasone propionate vs placebo applied as nasal spray on the     increase of allergen-specific serum IgE levels following nasal exposure to recombinant     allergens. Nasal sprays will be applied for four weeks starting two weeks before nasal     provocation and serum IgE levels will be followed during eight weeks after nasal provocation.   "
222402|NCT00756353|"     This study was a survey of drug users who obtain buprenorphine from the black market and have     used buprenorphine during the last month. Subjects were surveyed at various locations     (streets, railway stations, etc.) with a few simple questions in order to describe the use of     buprenorphine in this out of care population.   "
222518|NCT00767013|"     We sought to determine whether the dual-source computed tomography assessment of aortic valve     stenosis and coronary artery disease is equivalent to or even better than conventional     invasive coronary angiography and transthoracic echocardiography.   "
222307|NCT00755079|"     The primary purpose of this study is to determine the effect of administration of the oral     beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with     cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings     with those obtained in a demographically matched group that will receive placebo.     Participation in this study will involve 12 weeks of pharmacological intervention during     which participants will be randomized to receive either oral albuterol 4mg twice daily or     placebo. All investigators and study participants will be blinded to randomization by our     research pharmacy. Participation in the study will require study subjects to come to our lab     for the total of 2 visits (at baseline and after week 12), during which a series of tests     will be performed to assess their respiratory muscle strength and pulmonary function.   "
222308|NCT00755092|"     Psychological care during labor is considered as an important supplemental procedure for     alleviating delivering stress and pain. Although Doula has been recommending that should be     given for parturients, its precise effect on nulliparous and multiparous women is still     unknown. The investigators hypothesized that multiparas had experienced the process of labor,     but the nulliparas were not, so Doula support would produce different effect on these two     population.   "
222309|NCT00755105|"     This is an observation study of subjects who previously had iron-55 isotope administered in     studies of iron absorption. By determining the retention of the isotope in blood during a     3-year period, body iron excretion can be measured.   "
222310|NCT00755118|"     The aim of this study is to evaluate the efficacy of the effective drugs in a alternating     chemotherapy schedules in pretreated patients with mCRC, who have received all effective     drugs.   "
222311|NCT00755131|"     This purpose of this study is to examine the relationship between HMGB-1 and postinfarction     predictors of outcome such as cardiopulmonary and echocardiographic parameters before and     after a 6-month exercise-based cardiac rehabilitation program.   "
222312|NCT00755144|"     This is a prospective Randomised Control Trial to compare the Early Clinical and Functional     Outcome of the ROCC and LCS total knee arthroplasty implant designs.   "
222313|NCT00755157|"     This trial will evaluate the efficacy and safety of metronomic docetaxel and bevacizumab     combination in patients with pretreated, advanced small cell lung cancer.   "
222314|NCT00755170|"     This trial will evaluate the efficacy and safety of metronomic vinorelbine and bevacizumab     combination in patients with pretreated, advanced non small cell lung cancer   "
222315|NCT00755183|"     The objective of this study is to assess the safety and efficacy of testosterone 0.03%     ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.   "
222316|NCT00755196|"     The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment, 5%,     compared to Ointment Vehicle, applied twice daily for 12 weeks, in the treatment of plaque     type psoriasis   "
222317|NCT00755209|"     The study's objective is to evaluate the effectiveness and safety of tranexamic acid for     adult patients with moderate to severe TBI.With the research question as Does TXA reduce the     incidence of progressive intracranial haemorrhage by 50% compared to placebo in moderate to     severe adult TBI patients at Khon Kaen Hospital?   "
222318|NCT00755222|"     This study evaluated the safety and effectiveness of AA4500 in improving the impact of     Peyronie's disease on quality of life and improving penile curvature in men with Peyronie's     disease   "
222319|NCT00755235|"     This study will test whether an electronic system that monitors and sends messages to help     people with depression could be feasible, acceptable, and potentially effective as a     treatment.   "
222320|NCT00755248|"     The purpose of this study is to determine the relations between conventional and     unconventional risk factors and adverse clinical events at follow-up (including coronary     bypass patency) in patients undergoing surgical myocardial revascularization.   "
222321|NCT00755261|"     This research is being done to find out if adding a drug called Avastin to an already     approved regimen used for soft-tissue sarcoma, Doxorubicin, will improve overall survival,     and slow disease progression. The study will also evaluate the overall safety of combining     these drugs. It is not known if combining these drugs will improve outcome. Avastin has been     approved for the treatment of metastatic carcinoma of the colon or rectum. It is not approved     for the treatment of soft-tissue sarcoma when added to Doxorubicin.   "
222322|NCT00755274|"     Primary Objective:      To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from     healthy children receiving the 2008-2009 formulation of the inactivated, split-virion     influenza vaccine Fluzone® for further study.      Observational Objectives:      To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine,     administered in a one- or two-dose schedule in accordance with Advisory Committee on     Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.      To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine,     administered in a one- or two-dose schedule in accordance with ACIP recommendations, in     children ≥ 6 months to < 5 years of age.   "
222323|NCT00755287|"     This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared     to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately     controlled with metformin and sulphonylurea combination therapy. Patients will be randomized     to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg     once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to     continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years,     and the target sample size if 500+ individuals.   "
222386|NCT00756145|"     Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the     session. In the present study we compare 3 different methods of injection of LMWH: parameters     of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each     patient.   "
226575|NCT00811642|"     The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of     a 12-week treatment with Posaconazole Oral Suspension in participants with IFI   "
222413|NCT00756509|"     The purpose of this multicenter, single-arm, exact binomial single-stage, phase II trial is     to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic     gastrointestinal stromal tumors   "
234121|NCT00912106|"     To analyze the relationship between composition of synovial fluid and its lubrication     properties   "
222324|NCT00755300|"     In patients undergoing total knee arthroplasty, thromboembolism is a common occurrence,     especially following tourniquet deflation. The resulting cardiopulmonary emboli can     potentially lead to hypoxemia, hypotension, hemodynamic collapse and post operative cognitive     dysfunction due to emboli. The standard surgical technique involves placing an intramedullary     rod in the femur to determine the angle and degree of resection from the end of the femur. A     new surgical technique utilizes computer navigation system to perform the desired cuts in the     appropriate position. The investigators hypothesize that the avoidance of intramedullary     instrumentation in computer assisted total knee replacement will result in fewer     thromboembolic events compared with the standard technique using manual instrumentation in     the femur. The present study will test this hypothesis by quantifying the extent of     thromboembolism during both surgical techniques.   "
222325|NCT00755313|"     RATIONALE: Gathering information over time from laboratory tests, imaging scans, and     assessment tests may help doctors learn more about the side effects of chemotherapy and plan     the best treatment.      PURPOSE: This clinical trial is studying the effects of chemotherapy on the brain in women     with newly diagnosed early-stage breast cancer.   "
222326|NCT00755326|"     The purpose of this study is to determine if the traditional Chinese herbal compound     (Huo-Luo-Xiao-Ling Dan, or HLXL) is effective in treating OA of the knee in addition to     participants current OA of the knee treatment(s) and also to determine the best dosage of     HLXL that is safe and well tolerated.   "
222327|NCT00755339|"     This study will investigate the sensation that many people with Tourette syndrome (TS)     experience before they have a motor tic. It will also test whether blocking the sensation     causes the tic to stop.      People between 18 and 65 years of age with TS who have at least once tic involving an arm may     be eligible for this 3-part study. Those enrolled may participate in all parts or in part 1     or part 2. Those who choose to participate in part 3 must first complete part 2. All must     stop taking medication for TS and any other medication that may affect the brain for at least     1 week before the study.      Part 1      After numbing the skin or muscles of the arm or leg where a pre-tic sensation is experienced,     the response of the nerves will be tested by asking subjects to rate the strength of the     sensation after a pinprick and by stimulating the nerves with small electrical shocks. Then,     over the course of approximately one hour, subjects will report pre-tic sensations while     their motor tics are counted. The onset of each tic will be identified with EMG, a test using     electrodes on the skin to indicate the activity of the muscles.      Part 2      Subjects brain waves are recorded using magnetoencephalography (MEG) while they are     experiencing tics andpre-tic sensory experiences. MEG is a test that records magnetic field     changes produced by brain activity. Subjects sit in a chair under a dome containing magnetic     field detectors. They watch a clock and report the time a sensory experience starts. Tics are     recorded with EMG. Later, a standard MRI of the brain (scan using a magnetic field and radio     waves) is done to see which parts of the brain produced the activity recorded with MEG.      Part 3      Repetitive transcranial magnetic stimulation (rTMS) is used to try to stop the pre-tic     sensations. For TMS, the subject sits in a chair. A wire coil is held on the subject s scalp,     and a brief electrical current is passed through the coil, creating a magnetic pulse that     stimulates a region of the brain. The goal of this stimulation is to reduce the sensory     experience that precedes a tic in one region of the body. During stimulation, the subject     hears a click and may feel a pulling sensation on the skin under the coil. There may be a     twitch in the muscles of the face, arm or leg. This study uses a pattern of repeated pulses     delivered in short bursts. Following each train of pulses, the effect of the stimulation on     sensation will be tested by asking the subject to rate the strength of a pinprick and of a     vibration. In addition, the nerves are stimulated with small shocks to evaluate the effect of     the TMS on nerve activity. To determine the effect of TMS on the pre-tic sensation, subjects     are asked to watch a clock and report when they are having a sensory experience. The effect     on motor tics will be evaluated by using EMG to indicate the tics.   "
222328|NCT00755352|"     Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and     lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least     4 weeks.   "
222329|NCT00755365|"     Mortality associated with pelvic fractures resulting from blunt trauma ranges between 6 and     18%. In cases where hemodynamic instability is also present, the mortality rate is     significantly greater, and has been reported as high as 60%. There is no general consensus     among traumatologists as to the initial management of this complicated subgroup of patients.     It is largely debated whether emergent orthopedic fixation or angiographic embolization     should be the first line of treatment for pelvic hemorrhage   "
222330|NCT00755378|"     This is a study to evaluate safety, tolerability, PK and PD effects of orally administered     AZD8529 after single ascending doses   "
222331|NCT00755391|"     This pilot study will evaluate the effectiveness of individual cognitive behavioral therapy     (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents.   "
222332|NCT00755404|"     The current study is initiated in order to assess the impact of a PD solution containing     L-carnitine on insulin sensitivity evaluated by measuring insulin requirement.   "
222333|NCT00755417|"     Depomed's Gabapentin Extended Release (G-ER) is an investigational, extended release     formulation of gabapentin that is being studied for the treatment of hot flashes in     postmenopausal women.   "
222334|NCT00755430|"     Autism spectrum disorder (ASD) has been given a high priority for genetic and neurobiological     study. There is no such information in Asian population and no study has conducted using     Diffusion Spectrum Imaging (DSI) to investigate the connectivity throughout the world.     Moreover, no follow-up study has been done to examine the developmental changes of structural     and functional connectivity. We anticipate to establishing a cohort of 50 ASD and their     siblings with complete clinical, neuropsychological, brain imaging, and genetic data for     longitudinal study on ASD. Our findings will contribute to our understanding of the     structural and functional dysconnectivity for ASD and whether dysconnectivity can be an     endophenotype for ASD and used as a biomarker for early diagnosis of ASD.   "
222335|NCT00755443|"     The purpose of this study was to determine whether Sirolimus stent implantation is effective     in reducing neointimal hyperplasia as compared to Bare metal stent in diabetic patients with     de novo coronary artery stenosis.   "
222336|NCT00755456|"     The current study is initiated in order to assess the impact of a PD solution containing     L-carnitine on insulin sensitivity measured by a hyperinsulinemic euglycemic clamp.   "
222337|NCT00755469|"     When angioplasty (PTCA) and stenting of the blood vessels of the heart is the treatment for a     Heart Attack, there is damage to the heart muscle that is caused by the sudden opening of the     blood vessels. This is called reperfusion injury. The cell death is due to inflammation and     the generation of free radicals.      The primary objective of this study is to determine if post-conditioning(four brief (30     second) PTCA balloon inflations) reduces damage to the heart muscle. This will be measured by     heart enzyme tests-CK measurements- and by cardiac MRI.   "
222338|NCT00755482|"     The objective of this trial is to evaluate the effect of Aquamin F versus placebo on NSAID     (non-steroidal anti-inflammatory drug) dose reduction in subjects with osteoarthritis of the     knee.      Hypothesis 1: After 12 weeks of treatment, subjects taking Aquamin F will use significantly     less NSAID medications for symptoms of osteoarthritis versus placebo alone.      Hypothesis 2: No significant differences will be seen for adverse events between the subjects     taking Aquamin F or placebo.   "
222343|NCT00755547|"     Background:      The investigators know that exercise helps children develop strong bones and muscles and     generally stay healthy. What is unclear however, is how much exercise a child needs to lower     their risk of developing type 2 diabetes.      Objective:      The investigators will try to find out whether high-intensity exercise for a short-period of     time is better than moderately intense exercise for improving the diabetes risk profile in     teens who are at risk for type 2 diabetes.      The working hypothesis is that exercise-mediated improvements in insulin sensitivity (a risk     factor for diabetes) will be greater following vigorous intermittent physical activity than     following low intensity physical activity in overweight adolescents 13-18 yrs at risk for     T2DM.      Brief Description of Research Project: Teenagers between the ages of 13 and 18 yrs, who are     at risk for type 2 diabetes (either by their family history or an abnormal response to sugar)     will be randomly assigned to one of two activity groups or a control group. The activity     groups will have supervised exercise sessions 3 to 5 days per week for 6 months. One group     will do high-intensity exercise, and the other will do lower-intensity exercise. We will     measure how sensitive their body is to insulin and the amount of fat in their muscle and     liver tissue at the beginning and end of the exercise intervention.   "
222344|NCT00755560|"     The purpose of this study is to evaluate effectiveness of albendazole in the treatment of the     asymptomatic infection with the parasite Toxocara in children. Treatment response is defined     as a reduction in the number of eosinophils in blood. The study drug will be compared to     placebo and randomly assigned in a double blind manner. Follow up will be prospective. 50     children (25 per group) will be enrolled in the study.   "
222345|NCT00755573|"     The aim of the study is to investigate the effect of pregabalin in pain resulting from     chronic pancreatitis. The effect will be investigated by means of questionnaires concerning     the daily experience of pain and the general quality of life. Furthermore the patients will     be invited to participate in experimental testing with a multimodal pain model. The     experimental testing will include stimulation of the skin, muscle and visceral tissue. The     results from the experimental part of the study may help us to understand the mechanisms of     action of pregabalin in this patient population.   "
222346|NCT00755586|"     The purpose of this study is to assess muscle improvement after stem cell injection in the     biceps muscle of patients with a brachial plexus injury.   "
222347|NCT00755599|"     This study will determine patient and provider preferences regarding vaginal speculum     examinations done with and without stirrups.      Primary research hypothesis: Women undergoing speculum examination will experience at least     20% less physical discomfort, 20% less sense of vulnerability, and 20% less sense of loss of     control when using a no-stirrup method of examination compared to traditional in-stirrup     examinations.      Secondary research hypothesis: 25% or less of the providers taught this alternative method of     speculum examination will find it to be unacceptable.   "
222348|NCT00755638|"     Single center, randomized, single dose study to evaluate the safety, tolerability,     pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers   "
222349|NCT00755651|"     The investigators have developed a novel instrument for taking endometrial biopsies at no     touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with     speculums and tenaculums, and also avoids the possible need for cervical dilatation. The     investigators wish to study the ease of use and efficacy of the new device compared with     traditional techniques of endometrial sampling at hysteroscopy.   "
222350|NCT00755664|"     The purpose of this study is to evaluate whether low dose complex B-vitamins (folic     acid,vitamin B6 and vitamin B12) can lower the risk of developing hyperhomocysteinemia in an     apparently healthy population with low folate/B12 and high Hcy status.   "
222351|NCT00755677|"     This is a single site, open registration, dietary proof of concept, food substance study     designed to explore the health benefits associated with daily pulse consumption in     individuals with peripheral arterial disease. The investigators hypothesis that a diet     containing at least one serving of pulse crops (dried beans, peas, lentil, chickpeas) per day     provides flavonoid compounds that improve cardiovascular health by increasing the levels of     serum adiponectin is based on evidence from the literature that indicates flavonoids present     in these foods are capable of improving arterial stiffness and reducing hypercholesterolemia.   "
222352|NCT00755690|"     This study is designed to describe the physiological response to increased and decreased     dietary phosphate intake on various parameters of mineral metabolism in the blood and urine     of individuals with Chronic Kidney Disease stage 3 and 4 with normal serum phosphate levels.     This detailed study will give us a far greater understanding of the role of diet in abnormal     mineral homeostasis early in the progression of this chronic disease. The findings of this     study will help both physicians and dietitians better determine the optimal time to introduce     dietary therapy in CKD.   "
222353|NCT00755703|"     The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in     healthy adults volunteers. Single dose, intranasally administered vaccine using an     adenovirus-recombinant vector has provided a safe route for inducing protection in animals     against pandemic influenza in preclinical studies.      The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.   "
222354|NCT00755716|"     Specific aims:        1. To obtain pilot data on 4-week continuous quit rates associated with 10 weeks of          treatment with topiramate or placebo or topiramate plus nicotine patch for smoking          cessation.        2. To obtain pilot data on the effects of 10 weeks of topiramate versus placebo versus          combination of topiramate plus nicotine patch on nicotine withdrawal symptoms, smoking          satisfaction, and adverse effects during smoking cessation.        3. To obtain pilot data on weight gain over 10 weeks with topiramate versus placebo versus          combination of topiramate plus nicotine patch for smoking cessation.   "
222355|NCT00755729|"     The purpose of this study is to delineate the effects of preoperative oral carbohydrate on     immediate postoperative insulin resistance (PIR) in patients undergoing elective open     colorectal cancer resection, and to further clarify the hypotheses that preoperative oral     carbohydrate treatment attenuates PIR in patients by enhancing insulin signaling to     PI3K-dependent pathway.   "
222400|NCT00756327|"     To determine whether AquaLase capsule wash reduces posterior capsule opacification (PCO) in     pediatric eyes.   "
226576|NCT00817557|"     Study of the effects of Loteprednol on CL dryness   "
222356|NCT00755742|"     Chronic hepatitis C (CHC) infection affects approximately 1 in 100 Canadians. Untreated, CHC     has significant long-term consequences including cirrhosis, liver cancer and liver failure.     CHC is intrinsically linked to both obesity and insulin resistance (IR) or pre-diabetes,     their co-existence worsens overall health outcomes. We have demonstrated that obesity (BMI     ≥30kg/m2) is over twice as common amongst patients with CHC (28.8%) compared with the general     Canadian population. Obesity superimposed on CHC reduces the success of antiviral treatment     and promotes liver scarring (hepatic fibrosis), fatty liver (steatosis) and increases the     risk of liver cancer. Both CHC and obesity contribute to IR putting these patients at risk of     type 2 diabetes. IR, like obesity in CHC, reduces antiviral success rates. We have shown that     diabetics are at higher risk of developing liver cancer compared with non-diabetics. It is     therefore timely to address lifestyle modification to delay the onset of diabetes. We will     examine the impact of a multidisciplinary lifestyle program on the insulin resistance in 52     obese pre-diabetic patients with current or past CHC. The 24 week program comprises an     individualized nutritional and exercise plan supported by behavior modification counseling.     Through gaining a better understanding of links between obesity, insulin resistance and     hepatitis C infection we hope to delay the onset of diabetes and reduce the likelihood of all     their untoward effects on the liver.   "
222357|NCT00755755|"     This trial will assess the efficacy and safety of PGL4001 with concomitant iron     administration versus placebo with concomitant iron administration, over a 3-month period for     the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding     due to uterine myoma.   "
222358|NCT00755768|"     The purpose of this study is to determine whether spending more time with a dietitian will     improve dietary compliance in a group of hemodialysis patients, with particular respect to     phosphate control.   "
222359|NCT00755781|"     A Phase III, multi-center, randomized, controlled study designed to demonstrate the efficacy     and safety of Cyclosporine Inhalation Solution (CIS)in improving survival and preventing     bronchiolitis obliterans syndrome (BOS) when given prophylactically to lung transplant     recipients in addition to their standard immunosuppressive regimen.   "
222360|NCT00755794|"     The purpose of this study is to evaluate the effectiveness of adding Montelukast Sodium     (singulair®) 10 mg per day to inhaled corticosteroids in adult subjects with uncontrolled     asthma.   "
222361|NCT00755807|"     This study is designed to primarily assess the efficacy and safety of duloxetine 60-120 mg     once daily (QD) compared with placebo on the reduction of pain severity in participants with     central neuropathic pain due to Multiple Sclerosis.   "
222362|NCT00755820|"     This is a research study to determine whether a medication called D-cycloserine (DCS) in     combination with a type of psychotherapy called Exposure Therapy is helpful to patients with     anorexia nervosa.   "
222363|NCT00755833|"     This study is conducted in Europe. The aim of this observational study is to evaluate the     blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with     type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective     is also to observe the different regimes of starting and maintaining the treatment with     NovoMix® 50 during one year.   "
222364|NCT00755846|"     The purpose of this study is to determine the safety and efficacy of alogliptin, once daily     (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of     sulfonylurea and metformin for treating subjects with type 2 diabetes.   "
222365|NCT00755859|"     In a previous trial the investigators found that the effect of steroids in IgA nephropathy     diminish over time. The difference in renal survival is striking up till the third year, but     then remains constant. A six-month course of steroid therapy may be not enough to ensure a     stable remission. The investigators hypothesized that a more aggressive treatment may obtain     long-term better results. The investigators conducted a randomised controlled trial to assess     the utility of low-dose azathioprine added to steroids in adult IgAN patients.   "
222366|NCT00755872|"     This is a randomized, open-label, multi-center, 4-treatment, 4-period crossover study.     Approximately 72 healthy, surgically sterile or postmenopausal subjects will be enrolled and     have urine collected over 72 hours following administration of risedronate for all 4     treatment periods).   "
222367|NCT00755885|"     RATIONALE: Abiraterone acetate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase I/II trial is studying the side effects and best dose of abiraterone     acetate and to see how well it works in treating postmenopausal women with advanced or     metastatic breast cancer.   "
222368|NCT00755898|"     The investigators have determined that the drug amantadine hydrochloride is metabolized by     acetylation by a specific enzyme named spermidine/spermine N-acetyltransferase (SSAT). This     enzyme is increased in cancer cells. The investigators hypothesized that the amount of     N-acetylamantadine excreted in urine during the first 12 hours after an oral dose would serve     as a diagnostic biomarker for the presence of cancer in a human test subject.   "
222369|NCT00755911|"     The purpose of this research is to determine if a subject's own bone marrow tissue can help     regenerate bone in the area of his/her jaw where a tooth has been removed using Tissue Repair     Cell (TRC) Therapy.   "
222370|NCT00755924|"     This is a double-blinded randomized placebo controlled prospective clinical trial evaluating     the impact of apple cider vinegar on serum HDL. 112 participants will be randomized to     consume either 2 tablespoons of vinegar daily or a placebo containing a 2% balsamic vinegar     solution in water. Baseline, two month and 4 month blood samples will be obtained for fasting     lipids. The primary endpoint is met if HDL levels increase in the treatment arm versus     baseline after 2 month intervention.   "
222371|NCT00755937|"     This registry is a multi-center, prospective, observational program that will gather and     analyze data on subjects with Crohn's disease being treated with Remicade® as per approved     product monograph in Canada. In contrast to a controlled clinical trial, there is no imposed     experimental intervention and treatment with Remicade® is determined solely by the subject's     physicians. Thus, the data captured and reported in this registry will reflect a real world     approach to the treatment of Crohn's disease with Remicade®.   "
222372|NCT00755950|"     The purpose of this study is to assess whether two higher doses (280mg or 420mg three times     daily)of silymarin therapy are safe and tolerable, and shorten the illness in patients with     acute viral hepatitis compared to placebo.   "
222373|NCT00755963|"     Menopausal and postmenopausal women compose almost 20% of the Austrian population. Two thirds     of all austrian women suffering from depression or anxiety disorders are over 45 years old.     The serotonergic system, partially regulated by the steroid hormones estrogen and     progesterone, plays a major role in the pathogenesis and treatment of these illnesses. To     examine the effect of the hormone replacement therapy on the serotonergic system, twenty-four     postmenopausal women will be measured using positron emission tomography (PET). The     volunteers will participate in two PET scans. The first PET scan will be performed right     before the hormone treatment starts, the second PET scan about 8 weeks after daily treatment     with (1) a combination of estrogen and progesterone or (2) estrogen and placebo. This imaging     study hypothesizes that the expression of the main inhibiting serotonergic receptor (the     serotonin-1A receptor) will be altered by the hormone therapy. The results of the study might     lead to new strategies in the treatment of psychiatric illnesses during and after the     menopausal transition.   "
222374|NCT00755976|"     RATIONALE: Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving sulindac together with epirubicin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving sulindac together with epirubicin     works in treating patients with metastatic malignant melanoma.   "
222375|NCT00755989|"     Morphine gel applied topically to wounds will reduce wound pain and decrease patients use of     oral and intravenous pain medications, therefore reducing side effects.   "
222376|NCT00756002|"     The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once     daily (QD), in subjects with chronic insomnia.   "
222377|NCT00756015|"     The purpose of this study is to better understand the influence of post-operative     rehabilitation on the rate of tendon healing and clinical outcomes following arthroscopic     repair of the rotator cuff. There are two schools of thought on what type of therapy program     is most beneficial following surgical cuff repair. However there has been little data     available to compare them. Therefore, the investigators would like to compare these two     standard plans of care so that the investigators may better define the safety and efficacy of     early mobilization of the shoulder versus keeping the shoulder immobilized following surgical     management.   "
222378|NCT00756028|"     Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to        1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure)        2. quality of life (2. outcome measure)        3. live birth rate (2. outcome measure)        4. gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol          and vascular endothelial growth factor in follicular fluid(not only compared between          GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS          and patients becoming pregnant and not becoming pregnant (2. outcome measure), and        5. number of oocytes removed per treatment, number of embryo transfers per treatment and          number of spontaneous abortions per treatment (these three parameters are tertiary          outcome measures).      In addition to the above mentioned efficacy outcome measures the safety outcome measure     frequency of known side-effects will be compared between the two protocols.   "
222379|NCT00756041|"     The purpose of this study is to determine the safety of TAK-128, once daily (QD), for     treatment of diabetic peripheral neuropathy   "
222380|NCT00756067|"     The purpose of this observer-blind study is to evaluate the safety, reactogenicity and     immunogenicity of pneumococcal vaccines in elderly. Subjects will be vaccinated twice with an     interval of two months.   "
222381|NCT00756080|"     The specific aim of this study is to determine whether oral citrulline administration     enhances whole body protein synthesis in healthy humans in the postabsorptive state. Protein     metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine.     The investigators hypothesize that citrulline supplementation will decrease leucine oxidation     without altering proteolysis, and consequently stimulate protein synthesis .   "
222382|NCT00756093|"     To evaluate drop comfort, acceptability and blur profile between four marketed artificial     tears in dry eye patients   "
222383|NCT00756106|"     RATIONALE: Diagnostic procedures, such as MRI, may help in learning how well radiation     therapy and chemotherapy work in killing tumor cells and allow doctors to plan better     treatment.      PURPOSE: This clinical trial is studying MRI scans to see how well they evaluate the effects     of radiation therapy and chemotherapy in patients with newly diagnosed glioblastoma     multiforme or anaplastic glioma.   "
222384|NCT00756119|"     Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in     sick patients is important for doctors to better treat these patients. Current procedures     available demand difficult invasive procedures and hence these parameters are not measured     with enough frequency and are also limited to certain patients. The new COstatus system is     capable of using the already existing arterial and venous lines placed in critically ill     patients and thus provides an opportunity to measure these parameters less invasively and     with enough frequency.      The purpose of this study is to measure cardiac output and blood volumes using ultrasound     dilution technology (COstatus system)in post cardiac surgery adult patients and compare the     cardiac output measurements with a current clinical reference method, thermodilution.   "
222385|NCT00756132|"     Women with breast cancer undergo treatments that decrease the chance of recurrence of cancer,     but are associated with several side effects, including declines in memory and attention and     other thinking abilities. The causes of these declines are not known. However, we know that     (i) people with cancer may have high levels of molecules in the blood (cytokines) that     reflect inflammation; (ii) injection of cytokines into animals, and their use to treat some     human diseases, can lead to decreased memory and attention; and (iii) in some advanced     cancers cytokines predict disease outcome. This longitudinal study evaluates the relation of     cytokines to decreased thinking abilities and to disease outcome over time. Results of this     study may help develop interventions to prevent or minimize cognitive decline and identify     women who are at high risk for recurrence, and such information could be used in treatment     decisions and in the development of new treatment options.   "
225219|NCT00799838|"     The purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia,     edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated     to amoxicillin.   "
222387|NCT00756158|"     The ultimate goal of this study is to find specific polymorphism of candidate genes     associated with endophenotypes and/or phenomenological phenotypes of ADHD. We propose to     replicate the analysis of the candidate genes identified by previous genetic studies on ADHD     using the candidate gene association study design (family-based case control study using     parental controls) to validate the findings from other research groups. These results will     lead our team: (1) to resolve controversies over inconsistent findings in previous genetic     studies and contribute to the literature on the validity of ASD using clinical and genetic     data; (2) to study the pathogenetic process of abnormal genes in abnormal neuropsychological     and neurobiological functions of ADHD; (3) to delineate the nature and the effect of     gene-gene interaction in the etiology of ADHD.   "
222388|NCT00756171|"     38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an     investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing     the effects of colesevelam on pruritus. Colesevelam is an oral, non-absorbable bile-acid     sequestrant much more potent than cholestyramine but free of adverse effects. It is     registered as a lipid lowering agent. The intensity of symptoms will be scored by means of     daily Visual Analogue Scales (VAS). Fatigue, quality of life and cutaneous scratch lesions     will also be evaluated using quantitative instruments.   "
222389|NCT00756184|"     A one-year, randomized, attention placebo-controlled trial investigating the value of     comprehensive adherence specific interventions, over the course of one year, to enhance     adherence in both (a) newly diagnosed open-angle glaucoma, or ocular hypertension patients,     naive to medical therapy and (b) those who have failed monotherapy with any prostaglandin     analogue (and are therefore candidates for adjunctive therapy) who then are randomized to     receive only travoprost monotherapy. Subjects will be randomized to two different     interventions involving direct physician education, each of which will take approximately the     same amount of physician time: The first will be intensive adherence education that will     continue throughout the year. The second will be intensive eye care education, but without     any direct adherence education. All patients participating in the study will be monitored for     adherence by the TDA. The study will demonstrate for the first time the role of     adherence-specific training in improving patient adherence and will validate the TDA in     monitoring and improving adherence in glaucoma. This will correlate with prior work that has     documented that greater adherence is associated with marked improvement in intraocular     pressure (IOP) control. A second goal will be seeing whether improving adherence will change     the course of glaucoma therapy by making therapeutic failures into therapeutic successes by     reducing the need for adjunctive therapy using only monotherapy with travoprost.   "
222390|NCT00756197|"     The purpose of this study is to evaluate the safety, feasibility, tissue response, and     subject side effects of liquid nitrogen sprayed through a catheter (CryoSpray AblationTM,     CSA or cryospray therapy) via endoscope in subjects with radiation induced proctitis.   "
222391|NCT00756210|"     The objective of this trial is to determine the effect of different lifestyle interventions     such as aerobic exercise and alternative resistance training methods, combined with a     hypocaloric diet, on weight, body composition and metabolic risk factors in overweight and     obese adults.   "
222392|NCT00756223|"     The main objective of this trial is to provide safety data in terms of drug-related adverse     events for the recommendation of the dose for further trials in the development of BI 831266.      Secondary objectives are the collection of antitumour efficacy data and the determination of     the pharmacokinetic and pharmacodynamic profile of BI 831266.   "
222393|NCT00756236|"     We will compare three study groups receiving metoprolol, esmolol, or placebo. Level of     anesthesia will be titrated to achieve the same range of BIS value in all groups. Our     hypothesis is that the metoprolol and esmolol groups will require a lower level of anesthetic     agent to achieve the targeted BIS range, compared to the placebo group.      Our objective is to clarify if metoprolol, in a dose range used for perioperative cardiac     protection, decreases anesthetic requirement.   "
222394|NCT00756249|"     The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO)     is a safe treatment for patients who have suffered an acute ischemic stroke.   "
222395|NCT00756262|"     The use of LGG will be associated with elimination of VRE colonization.      The primary comparison will be VRE elimination rates among those patients that receive LGG     compared to those that receive placebo. The primary endpoint will be the proportion of     patients with VRE at one week after cessation of administration of study medication or     placebo. The investigators assume that the placebo group will have very little spontaneous     elimination of VRE and that the LGG group will be more likely to have eliminated VRE     colonization at the end of one week.   "
222396|NCT00756275|"     The purpose of this study is to evaluate the effects of 12 weeks of varenicline as compared     to nicotine replacement therapy for smoking cessation among outpatients in treatment for     substance use disorders. The intervention also incorporates counseling (Brief Advice),     (adapted for sobriety settings), skills training and medication management.   "
222397|NCT00756288|"     Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for     the treatment of actinic keratoses.   "
222398|NCT00756301|"     Interventional spine procedures are an increasingly popular means of diagnosis and treatment     of spine disease. By convention, local anesthetics are used at the beginning of these     procedures with the goal of minimizing pain. However, the infiltration of the local     anesthetic is painful. This initial painful stimulus can heighten pain awareness and cause     anxiety or excessive movement during the procedure.      The purpose of this study is to determine patient discomfort with administration of cutaneous     local anesthetic prior to interventional spine procedures compared to no anesthetic     administration for different gauge procedural needles. Another purpose is to determine     patient discomfort with administration of local anesthetic by traditional technique compared     to an alternative technique and to develop a standardized technique and criteria for local     anesthetic administration during spine injection procedures that minimizes patient pain, and     may help reduce the overall risk of these procedures.      We plan to enroll a total of 200-300 subjects coming to Stanford for symmetric bilateral     single injections.   "
222399|NCT00756314|"     The purpose of this study is to determine whether contraceptive counseling is effective on     acceptance and use of methods in women following an abortion.   "
222403|NCT00756366|"     Heart failure affects approximately 5-6 million North Americans and is increasing in     prevalence. Sleep-related disorders, such as obstructive sleep apnea (OSA) often coexist     (11-37% incidence) with heart failure. OSA is the repeated temporary interruption of     breathing during sleep and occurs when the air passages in the upper respiratory tract become     blocked during sleep. OSA adversely affects the cardiovascular system resulting in hypoxia     (decrease in oxygen supply), which decreases the oxygen supply to the heart. Patients with     OSA are treated with continuous positive airway pressure (CPAP). It has also been shown that     CPAP reduces angina during sleep, minimizes sympathetic nervous system (SNS) activation and     improves left ventricular (LV) function, although the mechanism of action is not clear.     Carbon-11 acetate PET imaging allows for the assessment of how the heart works and how     efficiently the heart uses oxygen in certain circumstances. Carbon-11 hydroxyephedrine (HED)     measures cardiac nervous system activity, which may have an effect on heart rate. The study     will evaluate the term effects of continuous positive airway pressure (CPAP), a common     treatment for patients with OSA, on the heart's efficiency or ability to work and its effect     on the nervous system activity of the heart. Two patient groups will be evaluated 1.)     patients with congestive heart failure and obstructive sleep apnea will be randomized to     early or late CPAP to address the primary hypothesis of the study and 2.) patients with     congestive heart failure only (matched control group). Both the primary randomized study     group and secondary study group will be evaluated using [11C]acetate PET, [11C]HED PET and     echocardiography. Measurements will be obtained at baseline, 1 week (where possible) and 6-8     weeks.   "
222404|NCT00756379|"     The Century Trial is a single center Phase III randomized study sponsored by the Albert     Weatherhead III Foundation and conducted by Dr. K. Lance Gould. The study hypothesis is that     a combined image-treatment regimen of PET + comprehensive program of lifestyle modification     and lipid lowering drugs to target lipid level will result in an improved cardiovascular risk     score when compared to current standard optimal medical therapy, potentially resulting in a     lower rate of death, non-fatal myocardial infarction (MI) and revascularization procedures     during long term follow-up when compared with current standard of care. If our hypothesis is     correct, we will not only improve our ability to prevent and treat CAD but we will also     illustrate that, even with the expenses of behavioral interventions and imaging techniques,     we can be very cost effective. This information may help patients at risk or with known CAD     to obtain insurance coverage to prevent the disease as well as providing a more effective way     of treating it.   "
222405|NCT00756392|"     This study is designed to investigate whether filling the rectum with high density barium     prior to a magnetic resonance spectroscopy (MRS)exam of the prostate improves the quality of     the acquired spectrum. It is expected that the dense substance should help prevent air from     entering the rectum and thus susceptibility artifacts in the obtained MRS data should be     reduced. Ten patients with localized prostate cancer will be recruited for this study. There     will be no change in treatment planning based on MRS study. Patient will receive standard     radiation treatment prescribed by radiation oncologist.   "
222406|NCT00756405|"     The aim of the Antioxidant Study was to compare the efficacy of foods naturally rich in     antioxidants with that of antioxidants in a pill form on markers of inflammation and plasma     cholesterol in healthy adults at risk of cardiovascular disease.   "
222407|NCT00756418|"     A clinical study explores the safety and efficacy of montelukast and to compare the safety     and efficacy of montelukast with those of theophylline in pediatric bronchial asthma patients     when they are used in conjunction with inhaled steroids.   "
222408|NCT00756431|"     Evaluated whether HA coated dynamic hip screws can improve the surgical results in     trochanteric femoral fractures   "
222409|NCT00756444|"     Study 20080008 was a PK sub-study to study 20050251[Japan 20050251A]. This PK protocol was     amended 20-March-2009 and is now a Phase 2 stand alone study. There are no sites     participating in the U.S.      This study is designed to estimate the effect of panitumumab on the PK of cisplatin and 5-FU     in subjects receiving cisplatin and 5-FU with or without panitumumab.      To maximize any potential effect of panitumumab on the PK of cisplatin and 5-FU, the     collection of PK samples of cisplatin and 5-FU will be taken during cycle 2 of the study, the     point at which the PK of panitumumab is expected to be at steady-state after a dose of 9     mg/kg given every 3 weeks.   "
222410|NCT00756457|"     Posterior tibial tendon dysfunction (PTTD) is a problem with the tendon connecting one of the     lower leg muscles to the foot bone. PTTD can cause pain, swelling, and a flattened foot and     may require surgery if left untreated. Normal treatment for PTTD includes physical therapy     exercise. In treating similar conditions in the lower leg, exercises that are active, like     strengthening, seem to have better results than exercises that are passive, like stretching.     This study will determine whether adding strengthening exercises to a normal PTTD treatment     that includes wearing a brace and stretching is more beneficial than just wearing a brace and     stretching.   "
222411|NCT00756470|"     The goal of this clinical research study is to learn how well lapatinib taken alone, followed     by taking lapatinib with paclitaxel, and then taking lapatinib with 5-fluorouracil,     epirubicin, and cyclophosphamide (FEC75) works to help to control Inflammatory Breast Cancer     (IBC). The safety of this drug combination will also be studied.   "
222423|NCT00756639|"     The goal of this clinical research study is to learn if whole brain radiation can lower the     chances of developing brain tumors in patients with small cell carcinoma of the urinary     tract, including the bladder. The safety of whole brain radiation will also be studied.   "
225220|NCT00799851|"     Compare VBL and cyanoacrylate injection (CI) in the treatment of EV in patients with advanced     liver disease regarding eradication, bleeding, mortality, complication and recurrence rates.   "
222412|NCT00756483|"     Basic Protocol        1. Identify participant(s)        2. Request patient participation/Acquire Consent        3. Register patient at www.stabilityplus.net through the LOGIN tab             -  Patient ID (Name/Initials/SSN or any combination thereof)             -  Gender             -  Age             -  Surgical Procedure             -  Date of Surgery             -  Select Basic Exercise Program that corresponds with Surgical Procedure        4. Perform Initial Assessment using Basic Exercises for the Surgical Procedure        5. Enter Assessment Data at www.stabilityplus.net (through the LOGIN tab/Portal)        6. Within portal, modify Basic Exercise Program to create customized Stability Plus          prescription for the patient        7. Monitor patient progress through Stability Plus portal.   "
222414|NCT00756522|"     Chronic obstructive pulmonary disease (COPD) is a long-term lung disease. People with COPD     have difficulty breathing because of lung damage. However, for many people with COPD, while     some areas of the lungs are damaged, other nearby areas are not. This study will examine lung     tissue from people with and without COPD who are undergoing lung transplantation to     investigate how and why certain areas of the lungs are damaged in some people but not others.   "
222415|NCT00756535|"     The aim of the study is to describe the effects of physical exercise consisting of strength,     balance and flexibility training on functional abilities and the length of stay in older     (+75) patients hospitalized in a primary-care health- center hospital.   "
222416|NCT00756548|"     This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA     approved bowel preparation in adult subjects undergoing colonoscopy.   "
222417|NCT00756561|"     The purpose of this investigational study is to find out what hormones are present in healthy     male testicles using fine needle aspiration.   "
222418|NCT00756574|"     The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator     in protecting nurses from influenza in the hospital setting. The investigators propose a     non-inferiority randomized controlled trial whereby nurses are randomized to either a     surgical mask or an N95 respirator when caring for patients with febrile respiratory illness     during the influenza season. The hypothesis is that the surgical mask offers similar     protection against influenza to that of the N95. The specific objective of the study is to     assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as     secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for     respiratory illness, and lower respiratory infection), are similar among nurses using a     surgical mask compared to those using an N95 respirator.   "
222419|NCT00756587|"     The purpose of the current study is to investigate the effect of using cup feeding for     preterm infants during NICU stay on breastfeeding outcomes after discharge. The following     hypotheses are being tested:        1. Infants Fed by cup during NICU stay will have higher breastfeeding proportions than          infants fed by bottle        2. Infants fed by cup during NICU stay will have higher breastfeeding behaviour score on          the Preterm Infant Breastfeeding Behavior Scale than infants fed by bottle   "
222420|NCT00756600|"     The primary purpose of the GAS study is to determine whether different types of anesthesia     (Regional versus General) given to 720 infants undergoing inguinal hernia repair results in     equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of     apnea in the post-operative period after both regional and general anesthesia for inguinal     hernia repair in infants. This study is important as it will provide the greatest evidence     for safety or toxicity of general anesthesia for human infants.   "
222421|NCT00756613|"     CSP #465, Glycemic Control and Complications in Diabetes Mellitus Type 2, was a randomized     unblinded clinical trial comparing tight glycemic control to standard glycemic control. Tight     glycemic control consisted of giving patients appropriate diabetic medications to lower the     patient's HbA1c to around 7%, whereas standard control attempted to lower the patient's HbA1c     to between 8% and 9%. The study was conducted at 20 VA medical centers. One thousand seven     hundred and ninety two patients were randomized over the 2 year accrual period and then     followed for an additional 5 years. Follow-up averaged between 5 and 7 years depending upon     when the patient was enrolled in the study. Patients were seen on average every three months     in the VA Outpatient Clinics. High blood pressure and elevated cholesterol were aggressively     treated in patients in both treatment arms. Education regarding diet, exercise, smoking     cessation and management of very high and very low glucose was also provided. Data were     collected throughout the study on the patients' physical status, adverse and serious adverse     events, concomitant medications, and study end points including mortality, heart attack,     stroke and surgery to fix the arteries in the heart, legs or neck. The study consisted of     broad use of all anti-diabetic treatments commercially available between 2000 and 2008     including oral medications and insulin. Study required medications and all study clinic     visits were provided free of the usual VA co-pay. Active clinical follow-up of the sample     ended on May 31, 2008. With the end of the clinical trial the patients were transitioned back     to usual patient care services, treatment regimens were adjusted where appropriate and future     treatment will be dictated by the patient's health and his/her health care provider.      It is important to clarify that with the completion of the active clinical trial and     transitioning of patients to this observational trial, all responsibility for the care,     treatment and oversight of the study patients will become the responsibility of the patients'     Primary Care Physician. The Long Term Follow-up will not collect adverse or serious adverse     events, or actively treat or have any hands-on care responsibility for the study     participants.      The proposed Long Term Follow-up Study will consist of centralized computer database searches     and annual survey questionnaires related to quality of life and self-reported events     pertinent to the CSP #465 study.   "
222422|NCT00756626|"     This Integrated Project (Research + Extension) aims to reduce the risk of early childhood     overweight through changing bottle-feeding behavior. Excess bottles of whole milk and sweet     beverages beyond the advised weaning age of 12 months, inappropriate bottle-feeding, has     been linked to overweight. Our pilot of this intervention reduced bottle use.      COMPONENTS OF THE 'FEEDING YOUNG CHILDREN STUDY' (FYCS):        1. Randomized Controlled Trial (RCT)- of a bottle-weaning intervention in low-income          multi-ethnic toddlers, will enroll n=464 12 month olds using >2 bottles/day from two WIC          sites. Bottle use, anthropometrics, dietary intake, and nutrient density outcomes will          be assessed at Baseline, and 4 times over a 12 month follow-up.        2. Observational Study- nested within the RCT, will describe dietary intake and nutrient          density data (24 hour recalls) for this period of feeding transitions. FYCS fills a gap          in knowledge about this population's dietary habits, and their relationship to bottle          use.        3. Extension- our Marketing Department will produce: a 5-8 minute 'infomercial' and          nutritionist and client guides (freely downloadable) at WIC, maternal/child health, and          pediatric websites, and; a public TV segment. We will disseminate findings through a)          the National WIC Association, b) nutrition & pediatric journals, and; c) lay print,          media, and websites with assistance from our Public Relations Department.   "
222424|NCT00756652|"     In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel     silicone gel-filled breast implants for use in women who are undergoing primary or revisional     breast augmentation and primary or revisional breast reconstruction surgery. This     postapproval study is intended to satisfy one element of FDA's postapproval monitoring     requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of     data collection for the study to the collection of only secondary procedure/reoperation data     for MemoryGel participants.   "
222425|NCT00756665|"     The Prostate Active Surveillance Study (PASS) is a research study for men who have chosen     active surveillance as a management plan for their prostate cancer. Active surveillance is     defined as close monitoring of prostate cancer with the offer of treatment if there are     changes in test results. This study seeks to discover markers that will identify cancers that     are more aggressive from those tumors that grow slowly.   "
222427|NCT00756691|"     Hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's     tumour that may help predict patient outcomes and/or help inform patient management     decisions. 18F-FAZA Positron Emission Tomography (PET) can detect hypoxic tumours because     18F-FAZA accumulates in hypoxic tissues. This study is being done to learn more about the     processes by which 18F-FAZA is absorbed, distributed, metabolized (built-up and broken down)     and eliminated by the body.   "
222428|NCT00756704|"     Although 78% of smokers report that a health professional has previously advised them to quit     smoking, most smokers are not advised to stop smoking or offered assistance with smoking     cessation during a given ED visit. There are multiple barriers to routine implementation of     smoking cessation guidelines by emergency clinicians, however, and rigorously performed     clinical trials are needed to demonstrate that routine screening and counseling of ED     patients results in increased quit rates. To determine the feasibility of implementing the     Agency for Healthcare Research and Quality (AHRQ) Smoking Cessation Guideline in the ED, we     will conduct a clinical trial in 974 ambulatory adult smokers who present to 2 emergency     departments, using a pre-post design. During the 3-month baseline period, clinicians will     perform their usual duties but will not receive training in use of the AHRQ Guideline. Based     on the Chronic Care Model, the 3-month intervention period will include: 1) a tutorial on     brief cessation counseling for ED nurses and physicians, 2) use of an ED algorithm that     includes recommended tobacco counseling items, 3) fax referral of motivated smokers to     Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy, and     4) group and individual feedback to ED staff. We will conduct exit interviews of ED patients     to assess performance of guideline-recommended actions by ED staff and 3- and 6-month     telephone follow-up to determine 7-day point-prevalence abstinence (with biochemical     confirmation of self-reported quitters at 6 months). Our main analyses will examine the     contrast between the intervention and control periods in the performance of     guideline-recommended actions and in 6-month quit rates, using hierarchical logistic     regression to adjust for baseline differences in potentially confounding patient variables.     In secondary analyses, we will assess the change in attitudes of ED nurses and physicians     toward smoking cessation counseling. This feasibility study will determine the receptivity of     patients and ED staff to the guideline-based intervention and will provide estimates of     effect size in planning a full scale multi-site clinical trial of the study intervention in     community hospital EDs.   "
222429|NCT00756717|"     The purpose of this research project is to study the effect of a research (investigational)     drug, MK-0752 combined with either tamoxifen or letrozole on breast cancer cells.      Tamoxifen and letrozole are standard hormone treatments used to treat breast cancers that are     positive for the estrogen receptor. However, over time the breast cancer cells can become     resistant to tamoxifen and letrozole. MK-0752 is in a class of drugs called gamma secretase     inhibitors. Gamma secretase inhibitors may play a role in reversing the resistance to drugs     such as tamoxifen and letrozole.   "
222430|NCT00756730|"     For participants with HIV taking either lopinavir or fosamprenavir who have elevated     triglycerides, this trial will study the change in triglycerides after switching protease     inhibitors.   "
222431|NCT00756743|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.   "
222432|NCT00756756|"     The investigators applied G-CSF to patients 2 weeks after acute anterior MI and successful     PCI to evaluate the efficacy and safety of G-CSF in improving myocardial function as cytokine     which improve inflammation and mobilize stem cells from bone marrow for regeneration of     myocardium.   "
222433|NCT00756769|"     Systemic lupus erythematosus (SLE) is a severe, disabling systemic autoimmune disease     characterized by the production of autoantibodies. The clinical symptoms and immunologic     manifestations of SLE are diverse. African-Americans have a 3 fold increased incidence of     SLE, develop SLE at an earlier age, and have increased morbidity and mortality compared with     Caucasians. Our central study hypothesis is that there are specific genetic factors that     interact with environmental exposures leading to the development of SLE. The African-American     Gullah population lives on the Sea Islands of South Carolina and Georgia. They are unique in     their genetic homogeneity with minimal Caucasian admixture, making them an ideal cohort to     address questions of environmental and genetic influence on development and progression of     SLE.   "
222434|NCT00756782|"     The purpose of this study is to evaluate the efficacy and safety of TAC-101 after     Transcatheter Arterial Chemoembolization (TACE) in patients with advanced, unresectable     hepatocellular carcinoma (HCC) who are being scheduled for TACE.   "
222435|NCT00756795|"     The general hypothesis of this research is that patients who have undergone treatments for     Head Neck Cancer have a decreased quality of life and experience depression and fatigue.     Increasing and sustaining physical activity of these patients will improve their emotional     well-beings, increase their immunological response, improve wound healing, lessen fatigue and     improve their general functionality and quality of life.      The purposes of this study are to: (1) determine the effectiveness of the 12-week exercise     intervention program in increasing physical activity in head and neck cancer patients; (2)     determine if physically active patients differ in quality of life, depression and fatigue     during the course of the study; and (3) determine if the change in physical activity levels     is related to changes in the immune responses in human.   "
222448|NCT00756977|"     This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA     approved bowel preparation in adult subjects undergoing colonoscopy.   "
222449|NCT00756990|"     This is an investigation involving the use of a long-acting, injectable form (depot) of     naltrexone as a treatment for persons who have a history of opioid dependence, with up to 40     on parole/probation and 20 non-parolees. The test is a pilot study of up to 60 subjects     treated with 6 months of depot naltrexone plus Psychosocial Treatment .   "
222436|NCT00756808|"     In face of the increased rates of tuberculosis in residents of long term care facilities,     annual screening for latent tuberculosis is recommended. Tuberculin skin testing using     purified protein derivative (PPD) is used for this purpose. Sensitivity of the PPD testing     is, however, dependent on a normal T cell function. It is now evident that the immune system     undergoes age-associated alteration known as immune senescence. The depressed T-cell     responses may clinically manifest as attenuated delayed-type hypersensitivity. This     attenuated reaction may affect the sensitivity of the PPD in detection of latent TB in the     elderly.      This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay,     T-SPOT.TB, for detection of latent tuberculosis in nursing home patients who are 65 years of     age or older.   "
222451|NCT00757016|"     To evaluate the pain relief effect of locally injected corticosteroid treatment in women with     long-lasting low back pain beginning in pregnancy. We hypothesize that the insertion of the     sacrospinous ligament on the ischial spine would be a source of pain and therefore be a     target for therapy.      Primary outcome measure is reported pain intensity on visual analogue scale and secondary     outcome measures number of pain-drawing locations, pain-provoking test results and tests of     function.   "
222437|NCT00756821|"     The goal of this pilot study is to identify a marker or panel of markers in the blood or     urine from a wide range of Spinal Muscular Atrophy (SMA) patients that segregates with     measures of clinical severity. From this identification of candidate biomarkers, it is hoped     that further investigations, both longitudinal natural history and clinical efficacy studies,     will verify a biomarker with the sensitivity and specificity that will allow its eventual use     as a validated pharmacodynamic marker or surrogate endpoint. In addition, this effort may     elucidate biological pathways that may be potential therapeutic targets.   "
222438|NCT00756847|"     The purpose of this study is to evaluate the safety and tolerability of XL147 in combination     with paclitaxel and carboplatin in adults with solid tumors. XL147 is a new chemical entity     that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce     apoptosis (programmed cell death) in tumor cells. In clinical practice, the combination of     paclitaxel and carboplatin is an accepted treatment regimen for various solid tumors,     including ovarian cancer, endometrial cancer and non-small cell lung cancer (NSCLC).   "
222439|NCT00756860|"     The purpose of this study is to determine if subjects on 2g AMG 223 will achieve 60% or     greater reduction in urinary phosphorus from baseline compared to subjects on 2g Renagel®.      Renagel®, Sevelamer HCl is currently the market leader for the treatment of hyperphosphatemia     in patients on dialysis.   "
222440|NCT00756873|"     The aim of this study is to test the analgesic efficacy of etoricoxib (90 mg or 120 mg qd.     perioperatively) for post-operative pain relief.      The primary endpoint is as follows:        -  does preoperative etoricoxib reduce the post-operative opioid utilization in patients          undergoing elective tonsillectomy under general anaesthesia (i.e. the post-operative          opioid-sparing effect of etoricoxib in humans).      The secondary endpoints are as follows:        -  does the etoricoxib medication have an impact on PONV or activities of daily        -  does the etoricoxib medication influence the blood loss during surgery or the incidence          of postoperative bleeding        -  does the etoricoxib medication influence the operation time. In addition, adverse          effects of etoricoxib will be documented.   "
222441|NCT00756886|"     The purpose of this study is to determine if atorvastatin (Lipitor) reduces the occurence of     abnormal heart rhythm (atrial arrhythmia) following non cardiac thoracic surgery.   "
222442|NCT00756899|"     The Vitamin D study is designed to investigate the effect of body fat mass on vitamin D     levels in children. Earlier studies have shown that individuals with increased fat mass may     have low vitamin D levels.      Our specific hypothesis states that children with increased fat mass will have lower blood     levels of vitamin D when compared to non-obese children.Since vitamin D is the primary     hormone for bone mineralization in humans, low levels of vitamin D could lead to decreased     bone mineral content in these children.   "
222443|NCT00756912|"     This is a study designed to assess the safety of administration of up to 3 dose levels of     eritoran in subjects undergoing or scheduled to undergo allogeneic bone marrow transplant     (BMT). An allogeneic BMT is the transplantation of blood stem cells taken from the bone     marrow or blood of another person.   "
222444|NCT00756925|"     Cocaine dependence is an insidious disease underscored by a powerful proclivity to relapse     despite an individual's ability to recognize the deleterious consequences of continued drug     use. To date, there are only a limited number of treatments, and no FDA approved medications     for the treatment of cocaine dependence. Attempts to find reliable and successful treatments     for cocaine dependence may be marred by gender differences in brain chemistry, structure, and     function that are manifested as drug craving and relapse. For example, cues, drug exposure,     and stress promote relapse, yet females appear be more susceptible to stress induced relapse,     while males may be more susceptible to cue induced relapse. Therefore identifying the neural     substrates involved in processing the valence of internal and external stimuli may provide     further insight into cocaine dependence and provide more effective therapeutic strategies     aimed at preventing relapse.      Corticotropin releasing hormone (CRH) is a pharmacological activator of the hypothalamic     pituitary adrenal (HPA) axis, and has been implicated in stress induced drug relapse.     Corticotropin releasing hormone receptors are located at extrahypothalamic brain nuclei that     have been implicated in determining the significance of both internal (somatic) and external     (environmental) stimuli. The primary directive of this pilot project is to utilize functional     magnetic resonance imaging (fMRI) to identify possible brain nuclei associated with with     stress induced drug craving in cocaine dependent females.   "
222445|NCT00756938|"     This study will explore the dose-response of losartan as well as the safety and tolerability     in children from 6 months to 6 years of age.   "
222446|NCT00756951|"     Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or     radiation regiments used to treat cancer. This study examines the investigational drug SCV-07     and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can     possibly increase a broad immune system response, thus lowering the painful side effects     experienced when treated for head and neck cancer.      The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability     to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck     cancer.   "
222447|NCT00756964|"     Acute kidney injury is associated with a rise in serum uric acid during cardiovascular     surgery and can cause poor blood flow to the kidneys making them vulnerable to kidney injury.     We hypothesize that hyperuricemia, particularly if chronic and marked, is a risk factor for     acute kidney injury. The preoperative lowering of serum uric acid will reduce the incidence     of acute kidney injury following cardiovascular surgery.   "
222450|NCT00757003|"     PURPOSE OF RESEARCH:      Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to     open surgery that may decrease morbidity and mortality, particularly in high risk patients.     Optimal patient selection, based on pathology and anatomy, is being defined. Technically     successful implantation requires adequate assessment of pathology and anatomy, and     development and execution of novel and delicate procedures that resolve the pathology while     minimizing morbidity and mortality.   "
222452|NCT00757029|"     The noradrenergic system plays a known role in attentional systems and suspected causal role     in attention deficit/hyperactivity disorder(ADHD).Methylphenidate also has been suspected as     a inhibitor of norepinephrine transporter(SLC6A2). The investigators hypothesis is that     norepinephrine transporter polymorphism is associated with responses and adverse effects of     OROS-methylphenidate in treatment of ADHD.   "
222454|NCT00757055|"     The purpose of this study is to investigate whether the medicine ivabradine, a novel drug     which slows the heart rate has a favourable effect on patients with diastolic heart failure.      Ivabradine is a specific heart rate-lowering agent. It has a licence for treating patients     with angina who are intolerant of agents such as beta blockers or whose angina is not     adequately controlled. It has been shown to prolong exercise tolerance in these patients and     to reduce the frequency of chest pain. Its mechanism of action is felt to be purely due to     reducing heart rate, by as much as 10 beats per minute at rest, as well as by reducing the     heart rate response to exercise.      Patients with diastolic heart failure often complain of breathlessness on exertion which     relates to the stiffness or lack of compliance of their heart i.e. the heart fails to relax     rapidly enough to allow it to fill with blood between each heart beat. This may result in     high pressure in the heart chamber which backs up in to the lungs and may be experienced as     breathlessness. There is little evidence that any specific therapy benefits patients with     this type of heart failure besides treating coexisting problems such as high blood pressure     or angina. By slowing the heart rate down with ivabradine, the heart would have a longer time     to fill during exercise which would make it more effective. This slowing of the heart rate     may therefore relieve the breathlessness experienced on activity such as walking to the shops     or up a flight of stairs etc.   "
222455|NCT00757068|"     The purpose of this study is to evaluate the relative efficacy of a postpartum smoking     relapse prevention program, Strategies to Avoid Returning to Smoking (STARTS), and a     supportive, nondirective comparison condition (SUPPORT) to increase the proportion of women     who remain abstinent through 12 months postpartum. We hypothesize that women randomized to     STARTS will maintain higher rates of smoking abstinence at 6 and 12 months postpartum, and     expect STARTS to increase the length of time abstinence is sustained relative to SUPPORT.   "
222456|NCT00757081|"     The combination of phosphatidylcholine (PPC) and deoxycholate (DC) injected into subcutaneous     fat is often popularly referred to as Lipodissolve therapy. Despite its attractiveness as     an easy and noninvasive cosmetic treatment, the safety, effectiveness, and how the injections     might work remain unclear. This study will investigate the hypothesis that injections of     PPC/DC will reduce the amount body fat in the treated area. If so, the mechanisms responsible     for the fat loss will be explored to find out whether fat cells die from toxic effects or are     broken apart by the PPC/DC. Patients will receive at least 2 (no more than 4) treatments with     PPC/DC injections every 2 months. Several methods of measuring fat loss will be used in the     study, including photography and measurement of patients, tissue biopsy, blood tests, and     MRI. The study will also record side effects of the treatments as well as patient     satisfaction.   "
222457|NCT00757094|"     Fasting (refraining from eating and drinking) during the day is safe while receiving     chemotherapy.   "
222458|NCT00757107|"     This evaluation is conducted to evaluate the safety and performance of two different stem     lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are     compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and     radiostereomektric analysis   "
222459|NCT00757120|"     Emphysema, a common type of chronic obstructive pulmonary disease (COPD), is a long-term lung     disease that is usually caused by cigarette smoking. This study will examine both current     smokers and former smokers who have emphysema, as well as current and former smokers who do     not have emphysema, to determine if certain factors found in the blood are related to the     risk of developing emphysema.   "
222460|NCT00757133|"     The research hypothesis for this study is to possibly reduce the incidence of incisional     hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from     25% to 5% by mesh augmentation during closure of the laparotomy. The study is designed as a     prospective randomised multi-centre trial, randomising patients in 2 groups concerning the     surgical technique of the closure of the abdominal wall.   "
222461|NCT00757146|"     This is a chart review study of neonates admitted to Primary Children's Medical Center or     University of Utah NICU who had or developed a diagnosis of bronchopulmonary dysplasia (BPD)     and were treated for this condition with inhaled nitric oxide (iNO) beginning after the 4th     week of life. For this study BPD will be defined as need for supplemental oxygen on day 28 of     life. The data collection from the medical record will gather demographics on admission     (birth weight, gestational age, etc); past medical history from transferring hospitals;     admission diagnoses; hospital respiratory care treatment course and laboratory/xray findings;     nutrition and growth; and discharge diagnoses including all major neonatal morbidities such     as absence or severity of intraventricular hemorrhage, retinopathy of prematurity, or hearing     deficits. The data will be compiled and compared to data previously published on similar     infants with BPD but not treated with iNO.   "
222463|NCT00757172|"     RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     cisplatin and docetaxel, work in different ways to kill tumor cells or stop them from     growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination     chemotherapy together with panitumumab and radiation therapy before surgery may make the     tumor smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well giving panitumumab together with docetaxel,     cisplatin, radiation therapy, and surgery works in treating patients with newly diagnosed,     locally advanced esophageal cancer or cancer of the gastroesophageal junction.   "
222464|NCT00757185|"     The scientific aims of the study are to determine how peripheral microcirculatory     responsiveness is altered in obese women with Polycystic Ovary Syndrome (PCOS) during local     heating and to determine the mechanism for testosterone effects on peripheral     microcirculatory responsiveness in women with PCOS.   "
222465|NCT00757198|"     Prospective double blind study comparing two remifentanil dosing protocols (0.1 and 0.3     mcg/kg/min) during cardiac surgery. Main outcome measures are postoperative opioid     requirements (PCA oxycodone) and postoperative pain (VAS, verbal rating scale).   "
222466|NCT00757211|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between     genes and the environment in patients with breast cancer.   "
222467|NCT00757224|"     Parental smoking is associated with increased frequency of respiratory diseases including     hospitalizations in infants.      Study hypothesis: Parental education regarding the association between parental smoking and     respiratory diseases in the infant, and guidance on ways to decrease smoke exposure by the     infant, provided shortly after the infant is born, will decrease infants' morbidity.   "
222468|NCT00757237|"     The purpose of this study was to assess the comparative safety and effectiveness of aztreonam     for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients     with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.   "
222469|NCT00757250|"     The purpose of this study is to test the safety of an investigational medication, TXA127, and     its ability to increase T-lymphocyte counts, specifically CD4+ T-lymphocytes, in persons     infected with human immunodeficiency virus who are taking highly active anti-retroviral     therapy.   "
222470|NCT00757263|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This study is looking at genetic susceptibility for cancer and interactions between     genes and the environment in patients with ovarian cancer.   "
222471|NCT00757276|"     Evaluation of Copeptin in the differential diagnosis of diabetes insipidus.   "
222472|NCT00757289|"     The study is to compare the efficacy of autologous platelet concentrate injections to     corticosteroid injection in patients suffering from tennis elbow with respect to pain and     function.   "
222473|NCT00757302|"     Aim: This study aims at evaluating the performances of an intraoperative gamma camera (field     of view 10X10 cm), named CarolIReS, to detect axillary drainage and to assess the removal of     sentinel lymph nodes (SLN) in breast surgery. Patients and Methods: SLN biopsy will be     performed on 110 patients and the CarolIReS camera will be used preoperatively to localize     SLNs. During surgery, individual removal of SLNs will be performed using a gamma probe named     CarolIReS and their activity will be measured with a gamma ray counter. At the end of     surgery, the CarolIReS camera will be used again to check the quality of surgery which will     be followed by a surgical excision in case of remaining SLNs. Objectives: The main objective     of this study is to evaluate the performances of the CarolIReS camera in assessing the     axillary drainage of breast tumors and the surgical removal of SLNs. In addition, the     possible correlation between the activity, the size, and the metastatic involvement of the     SLNs will also be studied.Study hypothesis: Intraoperative cameras could be used to improve     the efficiency of the SLN procedure   "
222474|NCT00757315|"     Acne Keloidalis Nuchae (AKN) is a long standing hair follicle disease with bumps and scars on     the skin of the back of the head and neck. The purpose of this new study is to determine how     well a hair removal laser (NdYag Laser) works in treating AKN.   "
222475|NCT00757328|"     Cross-sectional observational, non interventional, multicenter study of retrospective review     of clinical records of ambulatory followed up bipolar patients in order to record     epidemiological aspects of the course of the disorder, more specifically of bipolar     depression episodes and the clinical practices carried out by psychiatrists in Spain in     bipolar depressive episodes   "
222476|NCT00757341|"     This study will assess the mass balance, metabolic disposition, and identification of     metabolites following single oral administration of [14C]-SKI-606 in healthy male subjects.   "
222477|NCT00757354|"     A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip     articulating surfaces in cementless total hip arthroplasty.   "
222478|NCT00757367|"     Lavage fluid (BAL) is inserted into a lung lobe using a flexible bronchoscope. The fluid is     aspirated out to remove any remaining TI. It's performed twice at specific time points in 12     healthy volunteers. BAL fluid will be analyzed for insulin and FDKP.   "
222479|NCT00757380|"     Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two     different Dyes for Epiretinal Membrane Surgery.   "
222480|NCT00757393|"     The primary objective of this study is to test the hypothesis that growth hormone,     administered daily by subcutaneous injection for 2 years will result in a significantly     greater BMD Z-score over optimal standard therapy.   "
222481|NCT00757406|"     To demonstrate that ImpediMed L-Dex U400 can be used to assess unilateral Lymphoedema of the     leg using the same principles for arms.   "
222482|NCT00757419|"     The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in     the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to     placebo (inactive substance). Safety and tolerability variables will be closely monitored     throughout the study.   "
222483|NCT00757432|"     The purpose of the study is to describe the patient experience, including pain scores, use of     pain medications, resumption of usual activities, and bowel function in the post-operative     period following robotic urogynecologic surgery. Additionally, to describe peri-operative     parameters of robot-assisted urogynecologic surgery.   "
222484|NCT00757445|"     This study presents the investigators results on patients treated for infection in the     implemented hip prosthesis. Debridement and prosthesis retention is the method, followed by     antibiotic treatment. The investigators present treatment results, predisposing factors and     microbiological data.   "
222485|NCT00757458|"     The purpose of this study is to verify the existence of bacterial and/or fungal contamination     during different technics of propofol with or without EDTA continuous infusion in patients     undergoing general anesthesia.   "
222486|NCT00757471|"     Macular Hole Surgery with two different Dyes   "
222487|NCT00764244|"     Macular edema is the main cause of vision loss in diabetic patients. Its treatment is mainly     based on laser photocoagulation, but has limited results. Alternative treatment are under     investigation, such as vitrectomy and intravitreal injections of triamcinolone .The aim of     VITRILASE is to compare the efficacy of these two treatments to laser photocoagulation for     diabetic macular edema.   "
222488|NCT00764257|"     The purpose of this study was to assess PREVELLE Shape (CX002), with respect to safety and     efficacy for one year following treatment, for correction of facial nasolabial folds and when     applied as an intradermal implant for lip augmentation.   "
222489|NCT00764270|"     The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to     reduce risk factors in people with documented heart disease and increased levels of     inflammation.   "
222490|NCT00764283|"     Three types of dressing will be compared to prevent postoperative epidural catheter     migration. Patients will be randomised to have a Tegaderm dressing, an Epi-fix dressing or a     Lockit-Plus dressing to secure the epidural catheter for postoperative analgesia. The length     of the epidural catheter visible at the patient's skin surface will be recorded after     insertion and every day until removal. The integrity of the dressing and problems with     analgesia will also be recorded.   "
222491|NCT00764296|"     The Specific Aim of examining wounds microscopically is to attempt to demonstrate the     presence of biofilm in chronic wounds and to understand these populations on a cellular     level.   "
222492|NCT00764309|"     The purpose of this study was to evaluate the safety of Dasatininb in the treatment of     scleroderma pulmonary interstitial fibrosis.   "
222493|NCT00764322|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about differences in DNA and predict how well patients will respond to     treatment and plan better treatment.      PURPOSE: This clinical trial is studying blood samples from women with breast cancer or     ductal carcinoma in situ who are receiving tamoxifen.   "
222494|NCT00764335|"     The purpose of the study is to detect differences in function between rehabilitated hip     arthroplasty patients with customized prosthesis v. commercial prosthesis and to reveal if     there exist differences in strength and cardiovascular capacity between hip arthroplasty     patients and healthy controls.   "
222495|NCT00764348|"     Patients who present to a wound care center for management of their wounds will be evaluated     clinically to establish if their wounds are chronic or acute. These patients will undergo     standard of care management of their wounds. If debridement is indicated for the patient, the     patient will be asked to participate in a study. Once the standard of care debridement is     complete, the material debrided from the wound, instead of being discarded into a biohazard     bag, will be prepared for shipment. The samples will then be shipped to the Center for     Biofilm Engineering where microscopic evaluation will be conducted on the material.     Conclusion will be made from that analysis.   "
222496|NCT00764361|"     This study is a double-blind, one center, two-arm study with a two (2) week Run-In,     evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied     to diabetic ulcers in concert with professionally administered Standard of Care (SOC)     procedures as described by Standard Operating Procedure(s) of the Department of Veterans     Administration Hospitals. During the run-in period patients with infected wounds will receive     oral antibiotic and not be included in the topical portion of the study until the infection     is shown by wound fluid analysis to be resolved. Following a two (2) week Run-In of all     patients to receive SOC treatment for diabetic ulcers, patients would have either the     investigational material or the placebo hydrogel applied as a part of their wound care. Each     patient would receive 1.5 gm packets of either the test article or the placebo hydrogel for a     once-daily home treatment accompanied by a dressing change.   "
222497|NCT00764374|"     To examine the safety and efficacy of Z-338 (YM443) after long-term administration in     patients with functional dyspepsia, and also to examine the pattern of long-term     administration.   "
222498|NCT00764387|"     Study to compare of two contrast agents in imaging brain lesions.   "
222499|NCT00764400|"     In this study the investigators are examining the effectiveness of two different speech     therapy protocols for word retrieval impairments experienced by individuals with     stroke-induced aphasia. One treatment involves errorless naming treatment and the other     employs verbal plus gestural facilitation of word retrieval. Participants will receive one of     the two treatments over several months. Before and after treatment the investigators will     administer several tests and conversational samples to examine changes associated with the     treatments. The investigators hypothesize that, whereas both treatments will lead to     improvements in words rehearsed in therapy, communication outcomes in conversation will be     broader for the verbal plus gestural protocol.   "
222500|NCT00764413|"     The Immunological system is showing a diurnal rhythmicity. The Mediators that enhances     inflammation are at highest level during the night. At the same time the endogenous     production of cortisol is at its lowest. We want to study if there is a better effect of     treatment with Methylprednisolone for acute MS-attacks if given at nighttime. The effect will     be measured in relation to neurological deficits and function with Kurtzkes Expanded     Disability Status Score (EDSS) and Multiple Sclerosis Functional Composite (MSFC). We want to     see if the mean improvement in EDSS is greater in the group receiving treatment at night     opposed to the group that get treatment during the daytime.   "
222501|NCT00764426|"     Effect of moderate alcohol consumption in form of red wine, beer and ethanol solution and     corresponding de-alcoholised beverages on immune measures.        -  In healthy middle aged men and women        -  In a randomized controlled cross-over trial        -  Two intervention periods over 3 weeks   "
222502|NCT00764439|"     Pilot study of a new nicotine replacement therapy for smoking cessation.   "
222503|NCT00764465|"     To date, no study has investigated whether there is a drug interaction between the protease     inhibitor fosamprenavir and the entry inhibitor maraviroc. COL112237 is a randomized,     open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir     (APV) and maraviroc (MVC) pharmacokinetics in 48 healthy, HIV-negative adults after     administration of a 7-day regimen of MVC 300mg BID alone and after 14-day regimens of     unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/RTV 100mg BID, or FPV     1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent MVC 300mg BID. Blood     samples for drug concentration measurement will be collected over 12 hours at the end of each     dosing period. Subjects will undergo a physical examination, complete blood count (CBC) with     differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and     lipid panel at screening, and all of these tests, except those for HIV and hepatitis B/C,     will be repeated at follow-up post-study. Adverse events and adherence (by pill count and     medication diary) will be assessed by the investigator/study personnel at the end of each     dosing period.   "
222519|NCT00767026|"     The purpose of this study is to determine if the program Creating Opportunities for Parent     Empowerment (COPE) is feasible to administer to parents of children with neurological     conditions. The goal of the study is to empower parents by providing them with educational     materials designed to teach them how to foster healthy coping skills in their child.   "
222504|NCT00764478|"     This trial will study the efficacy and safety of a fixed dose of asenapine in participants     diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly     assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily [BID]) or     placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each     participant at various times to assess the safety and effectiveness of the study treatment.     The primary hypothesis is that there is at least one dose of asenapine that is superior to     placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating     Scale [YMRS]) at Day 21 of the trial.   "
222505|NCT00764504|"     The objective of this clinical study is to evaluate the safety and efficacy of the Encore     Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to     clinical results published in literature for rotator cuff arthropathy and salvage procedures.   "
222506|NCT00764517|"     This phase II trial studies how well giving vorinostat, cladribine, and rituximab together     works in treating patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia     (CLL), or B cell non-Hodgkin's lymphoma (NHL) that has returned after a period of     improvement. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cladribine, work in different     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may     block cancer growth in different ways by targeting certain cells. Giving vorinostat together     with cladribine and rituximab may kill more cancer cells.   "
222507|NCT00764530|"     Evaluate the safety and efficacy of the CeramTec Acetabular Alumina Insert and CeramTec     Alumina head when used with the Foundation Porous Coated Acetabular Shell and an Encore hip     stem.   "
222508|NCT00764543|"     Children with unilateral congenital urine flow impairment, who require surgery, have abnormal     24-hour ambulatory blood pressure measurements.   "
222509|NCT00764556|"     Patients with chronic obstructive pulmonary disease (COPD) are commonly admitted to hospital     with exacerbations of their lung disease. A combination of the acute illness and treatment     with oral steroids causes a rise in blood sugar. Patients with high blood sugar do worse than     those with normal blood sugar. The aim of this study is to develop a safe and effective     protocol for tight control of blood glucose with insulin on acute medical wards outside the     intensive care environment. This will allow us to perform a formal trial to determine whether     blood glucose control with insulin reduces death and complications from COPD exacerbations.   "
222510|NCT00764569|"     The overall objective of this work is to identify changes in the optical properties of oral     tissues to develop a non-invasive tool for the detection, diagnosis and screening of oral     pathology so that treatment can be provided at the earliest possible time.   "
222511|NCT00766909|"     Cyclosporine (CsA) and Tacrolimus (Tac) are immunosuppressive agents comprising the     cornerstone of treatment among organ transplant recipients. Unfortunately diabetes is a known     complication after transplantation, yet the underlying mechanisms of this type of diabetes     are still unresolved. A direct comparison of the diabetogenic effects of CsA and Tac, without     interference of corticosteroid treatment, has not yet been investigated using a     hyperinsulinemic euglycemic glucose clamp technique, which is the best method for estimating     insulin sensitivity.      Randomized, investigator-blinded cross-over studies will be carried out, studying 10 healthy     subjects and 10 hemodialysis patients. Each participant will receive treatment with CsA, Tac     and placebo respectively in a random order. The results will be of relevance to the choice     and monitoring of immunosuppressive regimens in kidney transplant recipients as well as the     development of better treatment modalities for diabetes.   "
222512|NCT00766935|"     The purpose of this project is to prove that the Imp™SFB7+ (L-Dex U400) is equivalent to the     Imp™ XCA device in assessing Lymphoedema. The Imp™ XCA device is a simple device capable of     assessing Lymphoedema of a single arm. The Imp™SFB7+ (L-Dex U400) is a more complex device     capable of assessing Lymphoedema in a larger population of Lymphoedema sufferers. The     Imp™SFB7+ (L-Dex U400) will be developed to assess patients with Lymphoedema in their arms or     their legs. The Imp™ XCA and Imp™ SFB7 are both TGA approved devices. The Imp™ SFB7+ (L-Dex     U400) is similar to the Imp™ SFB7 the changes are to the software and user interface.   "
222513|NCT00766948|"     By creating a neurogenebank from Parkinson's disease patients' blood donations we will     ultimately be able to define genes for Parkinson's disease and other neurological conditions.   "
222514|NCT00766961|"     The aim of the study is to compare the outcomes of trans-catheter arterial embolization (TAE)     and surgery as salvage therapy of peptic ulcer bleeding after failed endoscopic therapy.   "
222515|NCT00766974|"     Objectives: To quantify the clinical improvement and quality of life between patients wearing     compression stockings versus anti-embolism stockings in patients with varicose veins and limb     edema.   "
222516|NCT00766987|"     Positron Emission Tomography (PET) is a non-invasive, unique nuclear imaging technique that     allows the evaluation of blood flow in the heart and provides information about the cell     activity of specific organs such as the heart and brain. It also provides useful information     for the management of patients with poor pumping function of the heart, heart failure, and     coronary artery disease. A cardiac viability imaging looks at how the heart uses glucose     (sugar) The imaging process determines areas of the heart that are alive (viable - using     sugar) versus areas of the heart that are scar tissue (non-viable). F-18 fluorodeoxyglucose     (FDG) is the radioactive substance used to determine myocardial viability. This nuclear     imaging technique has been shown to be useful in directing management for patient care.      The Ministry of Health recognizes the clinical utility of FDG PET imaging for myocardial     viability assessment and other cancer indications. Optimizing the potential advantages of FDG     PET in Ontario, will require characterization of the patient population, referral patterns,     upstream and downstream resource utilization and patient outcomes. Therefore, registry     studies are being undertaken to provide specific information about the utility of PET in     these clinical situations in Ontario. The proposed registry will facilitate monitoring of the     implementation of this limited technology and allow continued evaluation of practice patterns     and outcomes. The University of Ottawa Heart Institute is the coordinating centre for this     project with PET centres in London, Hamilton and Toronto also participating.      The purpose of this study is to evaluate the utility of FDG PET viability imaging in the     decision making process for patients with poor left ventricular function who may be     candidates for revascularization and to study the downstream effect of the clinical     management decisions. Patients meeting specific inclusion criteria will be eligible for this     study.   "
222517|NCT00767000|"     The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants     taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that     treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c     (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be     well-tolerated at 1 or more doses that demonstrate efficacy.   "
222520|NCT00767039|"     Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome     (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the     FDA were more concentrated and had a more rapid onset of action. The overall efficacy of     newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a     double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to     infants treated with Survanta, the most commonly used surfactant preparation in the United     States. While the data was suggestive, it was not clear that the improvement in survival was     reproducible or that Curosurf was responsible for the improved survival rates.      The purpose of this study was to investigate the role of Curosurf in improving lung function     and survival rates and reducing the complications of prematurity in very premature infants <     30 weeks gestational age at birth.   "
222521|NCT00767052|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to     evaluate the single-dose relative bioavailability of the oral suspension and oral tablet     formulations.   "
222522|NCT00767065|"     This is a randomised trial comparing early Cardiac Computed Tomography (CCT) to current     standard practice for diagnosis of acute chest pain in patients at low to intermediate risk     of having coronary artery disease (CAD), in a UK setting. We hypothesise that early CCT can     reduce length of admission, reduce NHS costs and improve quality of life whilst being at     least as safe as standard practice.   "
222523|NCT00767091|"     Apathy usually refers to a set of behavioural, emotional and cognitive features as a reduced     interest and participation in main activities of daily life, a lack of initiative, a trend     toward an early withdrawal from started activities, an indifference and a flattening of     affect. We have validated a new specific scale (Lille Apathy Rating Scale, LARS) in order to     detect and quantify apathy in Parkinson's disease (PD). Apathy was shown to be frequent in PD     with a prevalence of 32%. It has suggested that the medial frontal and limbic cholinergic     deficits may underlie apathy in neurodegenerative disorders like Alzheimer's disease (AD).     Such a hypothesis is supported by recent evidence indicating the beneficial effects of     cholinesterase inhibitors on neuropsychiatric symptoms, mainly apathy, in AD patients. As the     efficacy of rivastigmine on cognition has also been shown in PD, we aimed to assess with a     randomized, double-blind, placebo-controlled, parallel-group, multicenter trial, the efficacy     and acceptability of a 6 months treatment with rivastigmine on apathy in 60 patients with PD     without dementia. The primary end point will be the LARS score and the secondary end points     will be the cognitive, behavioural and motor symptoms of PD. Two add-on studies will be     proposed: first the measure of choline and glutamate peaks on Magnetic Resonance Spectrometry     focused on the structures implicated in apathy in order to give insights in the     physiopathological mechanisms of the treatment. Secondly, the recording of the REM sleep     behavior disorders in relation with the cholinergic part of the pedunculopontine nucleus.     Regarding that apathy could be one of the first steps toward PD dementia, treating very early     could have substantial implications on the patients and their caregiver.   "
222524|NCT00767104|"     The purpose of this research study is to better understand how this study pillowcase works     when people use it to treat acne. Most people, including people with acne, sleep six to eight     hours each night in direct contact with bedding fabrics that provide no benefit to the     healing process associated with acne. The fabric in this study pillowcase may be able to     reduce bacteria on the skin. This study would evaluate how acne is affected by this silk-like     pillowcase. This type of study has not been done before.   "
222525|NCT00767117|"     The purpose of the study is to determine the effect of steady-state concentrations of LPV,     co-administered with a low dose of ritonavir, on the steady-state pharmacokinetics of TMC125     and to determine the effect of steady-state concentrations of TMC125 on the steady-state     pharmacokinetics of LPV, co-administered with a low dose of ritonavir.   "
222553|NCT00767494|"     The purpose of the study is to compare the IOP lowering efficacy of Travoprost/Brinzolamide     dosed daily in the morning or evening, vs TRAVATAN dosed once daily in the evening, and vs.     AZOPT dosed BID in patients with open-angle glaucoma or ocular hypertension.   "
222526|NCT00767130|"     Lipitor®, Zocor®, and Crestor® are statin drugs commonly taken to lower cholesterol and     prevent heart disease. Statins lower cholesterol by different amounts in different patients     and sometimes statins cause muscle pain, cramps, or weakness. This study will examine genetic     differences in the blood of patients taking statins to predict both how well the statins     lower cholesterol, and whether muscle discomfort occurs. Finding such genetic connections is     the key to developing genetic tests that might eventually help determine which statin is best     for a patient. About 1000 people will be in the study.   "
222527|NCT00767156|"     The effect of oral supplementation of SBA24 sea buckthorn oil capsule and topical application     of Omega7 sea buckthorn cream on skin ageing is studied in a single blind, parallel study.   "
222528|NCT00767169|"     Dental implants (screws for fastening false teeth) have been coated with bisphosphonates     (drugs that slow down removal of bone). Patients get one such screw and one without coating,     by a surgeon who does not know which is which. The screws are compared by measuring how well     fixed they are by a vibration measuring technique, and x-rays. The hypothesis is that the     bisphosphonates will improve fixation.   "
222529|NCT00767182|"     Pregnancy complications called PVP are mainly responsible for perinatal mortality. In these     cases, the placenta is smaller and often the centre of thrombotic lesions. The estimation of     the placenta volume by 3D ultrasound coupled with growth factors and D-Dimers measures could     improve the understanding of these pathologies to optimize their detection.   "
222616|NCT00768339|"     AEG35156 has shown early evidence of activity in patients with advanced indolent B-cell     lymphomas in Phase 1 trials and merits further evaluation in this disease. This trial is     designed to determine the recommended dose of AEG35156 in patients with relapsed or     refractory chronic lymphocytic leukemia (CLL) and indolent B-cell lymphomas.   "
222617|NCT00768352|"     The purpose of this study is: 1) to assess pediatric resident knowledge of adolescent mental     health; 2) to assess pediatric resident comfort level for screening, assessing, and treating     mental health disorders in adolescents, and; 3) to evaluate pediatric resident current     practices for adolescent mental health screening, assessment, and treatment.   "
222530|NCT00767195|"     Pulmonary edema can be classified into cardiogenic pulmonary edema and non-cardiogenic     pulmonary edema according to the underlying etiology. Cardiogenic pulmonary edema is caused     by the dysfunction in the cardiac pumping capability, leading to the transudation     accumulation in the pulmonary peri-capillary space. The predisposing factors of     non-cardiogenic pulmonary edema are numerous, including severe infection, renal failure,     auto-immun reaction, etc. The mortality rate of pulmonary edema is relatively high,     especially the non-cardiogenic one. To distinguish the type of pulmonary edema at the early     stage is important for its treatment.      Lung sound analysis via stethoscope is a simple diagnostic method to lung diseases     clinically. Among many kinds of lung sounds, the crackle and rale are frequently found in     pulmonary edema. Rale is also called moist rale. It is considered as low-frequency     wheezes and is often seen in cardiogenic pulmonary edema. On the other hand, crackle is     also called dry rale, which is a kind of high-frequency wheezes and usually seen in Acute     Respiratory Distress Syndrome (ARDS) that is classified into non-cardiogenic pulmonary edema.      This proposed project intends to establish a digital diagnostic method for pulmonary edema.     The lung sound of patient with pulmonary edema will be collected by the lung sound     acquisition system. By identifying the significant spectrum characteristics of cardiogenic     pulmonary edema and non-cardiogenic pulmonary edema, the diagnostic system might be     established.   "
222531|NCT00767208|"     The aim of this trial was to compare postprandial metabolic response to glucose load in     healthy overweight and type 2 diabetic subjects, by using glycemia, insulinemia, lipid     profile, nutrient oxidation follow-up. Stable isotopes of glucose were used to assess     postprandial total,exogenous and endogenous glucose kinetics.   "
222532|NCT00767221|"     The study will investigate the effect of PL-56 on albumin leakage and renal function     (glomerular filtration rate) in patients with IgA nephropathy. It will also assess the safety     of treatment with PL-56.   "
222533|NCT00767234|"     To determine whether biomarkers assessed in blood samples can be used to detect individuals     at risk for developing blood clots or worsening of their underlying disease. The ultimate     goal of the study is to identify key biomarkers derived from blood that are most     characteristic and informative of individuals who will go on to develop a clotting     complication.   "
222534|NCT00767247|"     Analysis of antihypertensive treatment efficacy.   "
222535|NCT00767260|"     There were evidences that the non-immune mediated inflammatory pathways of cell damage     occurred in vitro in human islets upon hyperglycemia in type 2 diabetes mellitus. Autologous     stem cell therapies were an emerging set of therapies that showed promise with a low side     effect profile. we hypothesized that infusion of mononuclear cells from buffy coat obtained     from bone marrow might provide multiple signals for regeneration and inflammation-induced     lesion recovery of local tissues, of which the effect might be maximized by intra-arterial     pancreatic infusion through angiography and combination with hyperbaric oxygen therapy.      This trail includes a foregoing sub-trial that investigate the feasibility and safety of a     novel method for massive bone marrow collection. The traditional BM collecting procedure is     unfavorable because it yields minor bone marrow. Studies have shown that physiological     exercise can increase bone marrow blood flow, which might facilitate BM collection.      We plan to include a total of 60 patients with type 2 diabetes and randomly assign them to     either a control group or an exercise group (n =30 each). The patients in the exercise group     exercised 30 minutes before the operation. All patients underwent routine surgical care. The     collected BM volume, operation time, collecting speed , puncture times and pain scores during     the operation were recorded. Bone marrow samples were tested for CD34+ flow cytometry and     whole blood cell count.   "
222536|NCT00767273|"     To test the ability of new imaging techniques to monitor and predict response of pancreatic     cancer to radiation and/or chemotherapy.   "
222537|NCT00767286|"     RATIONALE: Patient abstract not available      PURPOSE: Patient abstract not available   "
222538|NCT00767299|"     The study is for Korean women who are postmenopausal and also suffer from osteoporosis.      The study will test if women who are given 20 mg of arzoxifene once a day for six months have     a less severe level of osteoporosis than those women who do not take arzoxifene.      All patients will receive 500 mg of elemental calcium and 400 to 600 IU Vitamin D daily     starting 4 weeks prior to study drug administration continuing through the 6 months of     therapy.   "
222554|NCT00767507|"     The purpose of this study is to demonstrate that patients receiving cangrelor infusion before     coronary artery bypass grafting have an acceptable safety profile and can undergo surgery     without excessive bleeding peri-operatively.   "
222555|NCT00767520|"     The purpose of this study is to determine whether exemestane plus dasatinib will be     well-tolerated and will increase progression-free survival (PFS) in the treatment of advanced     estrogen-receptor positive (ER+) breast cancer after disease progression (PD) on a     non-steroidal aromatase inhibitor (NSAI).   "
222539|NCT00767312|"     This study will determine if the level of virus in HIV-infected patients taking     antiretroviral medications for prolonged periods decreases or persists at a stable level. It     will also examine whether new gene changes (mutations) occur during drug suppression.      HIV-infected patients who are 18 years of age or older, have been enrolled in another NIH     protocol, have been suppressed on antiretroviral therapy and have very low levels of virus in     their blood may be eligible for this 5-year (or more) study.      Participants come to the NIH Clinical Center about every 6 months for a physical examination,     routine and research blood tests and leukapheresis to collect white blood cells for T cell     analysis. For leukapheresis, blood is collected through a vein much like donating whole     blood, but the blood is directed through a machine that separates and extracts the white     cells and returns the rest of the blood components to the patient. Patients may also have an     optional third clinic visit each year for another blood draw.   "
222540|NCT00767325|"     The purpose of the study is to assess early signs of response to abatacept+methotrexate in     metacarpophalangeal joints in both hands using power Doppler ultrasonography in patients with     active rheumatoid arthritis.   "
222647|NCT00768742|"     The primary objective of this study is to test the hypothesis that a minimum 75% volume     radiofrequency ablation of fibroids associated with menorrhagia results in reduction of     menstrual bleeding.   "
222648|NCT00768755|"     AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as     first-line treatment of patients with locally advanced, recurrent, or metastatic     non-squamous, non small cell lung cancer (NSCLC).   "
222541|NCT00767338|"     The primary research hypothesis is that microsurgical varicocelectomy will result in an     increase in live birth in infertile couples where the male partner has a palpable varicocele     and an abnormal semen analysis in comparison to male partners who do not have microsurgical     varicocelectomy.      The secondary hypotheses include:        1. To assess whether up to 4 cycles of intrauterine insemination confers any additional          increase in live birth rates compared to timed intercourse;        2. To examine spousal pregnancy rate as the secondary outcome; and        3. To study the effect of varicocelectomy in men with infertility, an abnormal semen          analysis, and a palpable varicocele on             -  Testicular semen analysis parameters;             -  Serological measures of FSH, LH, total and free testosterone and             -  Measures of quality of life and sexual function in both partners.   "
222542|NCT00767351|"     Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and     mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively     via the kidneys reduced renal function is a relative contraindication. We have earlier     demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below     that level the risk of lactacidosis, a severe complication, increases.      In the present study we plan to analyse serum levels of metformin repeatedly in patients with     moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as     trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be     taken two hours after intake of the morning dose of metformin. Renal function will be     estimated with creatinine and cystatin C at each occasion. The intraindividual variation of     metformin will be calculated.      The study rests on a new method for measuring metformin. The technique uses Liquid     Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding     acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is     injected into the LCMSMS-system. The total runtime for a sample is 6 minutes.      The study will show if variation in serum levels of metformin measured in the same patient is     high or low and thus give us better understanding whether a change i serum level is due to     biological variation or to increased retention caused by progressive renal failure.   "
222543|NCT00767364|"     Rotavirus infection is a common pediatric illness and is the leading cause of severe acute     gastroenteritis (vomiting and diarrhea) in infants and young children. Since February of     2006, an oral vaccine to prevent rotavirus has been approved by the Food and Drug     Administration (FDA). The company that makes the oral vaccine is Merck and Company. Since the     FDA approval, the American Academy of Pediatrics (AAP) and that Advisory Committee on     Immunization Practices (ACIP) has recommended the use of this oral vaccine in infants. A     previous rotavirus oral vaccine, Rotashield, was removed from the market for concerns that it     was causing an increase in a gastrointestinal (GI) disease called intussusception. However,     the new rotavirus vaccine was studied by the manufacturer and was not found to cause an     increase in the cases of intussusception. Intussusception is a disease in which a portion of     the GI tract folds back on itself leading to GI tract obstruction or back-up.      The manufacturer of the vaccine noted on package insert information that the vaccine was not     studied, originally, in infants with a history of GI disorders or in infants who have had     surgery on their abdomen. Currently, there is no information available in the scientific     literature about the use of the oral rotavirus vaccine in infants with GI diseases or those     who have had GI surgeries.      The objective of the study is the assessment of safety and tolerability of the oral RotaTeq®     vaccine for all infants participating in the study. All infants will be followed for clinical     adverse events with active safety surveillance for the first 42 days after each dose and also     monthly afterward for a total of 12 months from the first vaccination date. The secondary     objective of the study is to quantify the immunologic response will occur in all of the     infants in the study. Assessment of percentage of the number of infants who have a good     immune response (three-fold rise in IgA titer or greater) to the complete rotavirus vaccine     series (three oral vaccines in total) by a blood test to check the rotavirus immunoglobulin A     (IgA) level in infants with short bowel syndrome compared to normal infants will occur.      Infants, meeting eligibility criteria and whose parents have signed informed consent will     have their study information collected. These infants will be tested for the presence of     pre-vaccine anti-rotavirus antibody, IgA levels, as mentioned above. After the blood is     obtained, participants will receive their first oral rotavirus vaccine dose between the ages     of 6 weeks to 12 weeks of life per package insert information. This oral rotavirus vaccine     may be administered with other routine pediatric vaccines at the participant primary care     provider's office. The date of the rotavirus vaccine and lot number would be recorded on     vaccine administration date cards. Most participants will have their vaccines given through     the Infectious Disease clinic staff at the Children's Hospital of Michigan.      Subsequent doses of the oral rotavirus vaccine will be given at a minimal interval between     vaccines of four weeks. The third, and final vaccine dose must be given by 32 weeks of life.     Any adverse reactions to the vaccine will be reported on the National Vaccine Adverse Event     Reporting System and MedWatch forms.      Finally, two weeks after the participants have had all three oral rotavirus vaccine doses,     the second and final blood draw will take place for measuring the post-vaccine level of     anti-rotavirus antibody, IgA.      Participants in the study will be monitored by telephone contacts on days 7, 14, and 42 after     each dose and within 48 to 72 hours of each dose of the rotavirus vaccine regarding any     serious adverse events. Each infant will also be assessed in the clinical setting each week     after a vaccine dose has been given. As above, parents of participants will be asked to fill     out the vaccine report card and record the child's temperature, and any episodes of vomiting,     diarrhea, blood in the stools or fussiness for the first seven days. The parents will also be     asked to record any other events from day 8 through 42 after each vaccine is administered     such as fever, ear infection, runny nose, etc. Afterward, parents will also have monthly     phone call safety follow-ups during the 12 month period following the first vaccination. A     Data Safety and Monitoring Board will oversee the study and it's progress and will have the     ability to vote to stop the study.   "
222544|NCT00767377|"     The purpose of this study is to evaluate the efficacy and tolerability of the combination of     epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in     patients with unresectable advanced or metastatic gastric cancer (A/MGC). Since Mar 2011, two     addition second endpoints was added to the trial, one was to compare the consistence of two     types of PET Scan evaluation with routine CT Scan evaluation, the other was to search for     predictor factors of clinical results ( ORR,PFS and OS) with Pharmacogenomics methods. This     modification was approved by the Ethic Committee of Fudan University Cancer Hospital, and the     approval number was IRB50-15-1101A.   "
222545|NCT00767390|"     The Purpose of this clinical investigation is to observe the changes in relative conductivity     between the six ACL patches over time. In addition, the clinical investigation will evaluate     the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back.     During the study the adhesiveness properties of the patches will be evaluated.   "
222546|NCT00767403|"     This study will evaluate the effectiveness of an Internet intervention designed to reduce the     behaviors and symptoms of pediatric encopresis.   "
222547|NCT00767416|"     The primary objective of this study is to describe the 28-day post-final dose safety and     tolerability of three doses of MEDI-559 at 10^5 FFU when administered to healthy RSV     seronegative children 1 to <24 months of age.   "
222548|NCT00767429|"     Because the increasing fall problem, mainly due to an impaired gait and balance ability, this     study will investigate fall risk by detecting fall related movement characteristics. Based on     the promising results using accelerometry for accurate and objective gait analysis, fall risk     will be measured using a triaxial accelerometer.      At the moment our group is performing a study titled 'identify subjects at risk for falling     using accelerometry'. In this study, fall related movement characteristics (gait, balance,     stumble reaction) are identified in healthy younger and older subjects under standardised     laboratory circumstances. In this way, specific characteristics can be selected which are     responsible for fall risk.      The aim of this study is investigating if the acceleration based fall risk detector can be     applied in daily life with target groups.   "
222549|NCT00767442|"     Evaluate the ability to image oral mucosa in healthy volunteer by nonlinear microscopy   "
222550|NCT00767455|"     Cumulative Irritation Patch Test   "
222551|NCT00767468|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib in     treating patients with locally advanced or metastatic liver cancer and cirrhosis.   "
222552|NCT00767481|"     Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP     lowering efficacy and safety over 12 months of morning or evening instillations of     Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with     open-angle glaucoma or ocular hypertension.   "
222557|NCT00767546|"     There's high incidence of seborrhic dermatitis among patients suffering from Parkinson's     disease. Seborrhic dermatitis is caused by increased exertion of sebaceous glands. Previous     studies have shown an increase of sebum excretion rate in parkinsonian pateints. Other     studies demonstrated improvement in seborrhic dermatitis after anticholinergic treatment.     From these studies we concluded that there might be hyperactivity of the parasympathetic     system among PD patients, that cause increased exertion of sebum, therefore local injection     of botulinium toxin, which inhibitis acetyl choline realese, might improve the rash of     seborrhic dermatitis.      40 patients suffering from Parkinson disease or other parkinsonian disorders will participate     in this study.      Before treating the patients with botulinium toxin, we will measure the sebum exertion with     the sebumeter device and make clinical evaluation of the rash. We will also take a picture of     the rash.      Then Botulinium toxin (60- 100 units) will be locally injected to the rash area.      Two weeks after the injection the patients will be called and evaluated clinicly and by the     sebumeter. Then they will be checked again after 3 weeks, after a month and after two, three     and four month's.   "
222667|NCT00769002|"     This study is being done to learn how previous flu vaccination or previous infection with flu     virus affects the immune response to vaccination.   "
222558|NCT00767559|"     The purpose of this research is to find a better way to prevent the post operative     development of clots in the deep veins of the legs (also called Deep Vein Thrombosis or DVT).     DVT causes redness, swelling, and pain in the involved leg(s). Long-term complications may     include permanent swelling and pain of the leg(s), and even skin ulcers around the ankle. If     clots form in a leg after surgery, and break off, they can move to the lungs and block the     pulmonary artery (also called Pulmonary Emboli or PE). With PE there can be chest pain, chest     tightness, shortness of breath, coughing up blood, heart failure, and occasionally death.      Doctors have studied ways to reduce these complications. These studies led to the development     of drugs which interfere with your body's clotting processes. However, it is still unclear     which drug and which drug schedule is best. This study will evaluate two of the standard FDA     approved drugs using different dosing schedules.   "
222559|NCT00767572|"     Coarctation of the aorta (CoA) accounts for approximately 8% of all congenital heart     problems. Patients with CoA are well known to have an increased rates of early heart disease,     high blood pressure, heart failure and stroke. Abnormal arterial function (dilation and     constriction of the blood vessels) has been observed in these patients and likely contributes     to the increased risk of cardiovascular problems. However, therapies targeted at improving     arterial function have not been investigated in this population. Statin therapy (cholesterol     medicines like Lipitor) have been studied in other subgroups of patients with abnormal     arterial function and has shown benefit in improving arterial function and reducing risk of     cardiovascular problems.      The investigators hypothesize that patients with CoA have abnormal arterial function leading     to increased cardiovascular risk. We further hypothesize that statin therapy may improve this     problem. We plan to compile a complete database of information regarding these patients     cardiovascular health and propose to then examine the effect of atorvastatin (Lipitor) on     arterial function as measured by changes in arm arterial function tests.   "
222560|NCT00767585|"     The aim of this study is to determine the effect of aromatase inhibitors therapy on bone     mineral density and compare it to the effects of tamoxifen and no hormonal therapy.   "
222561|NCT00767598|"     In order to evaluate the effect of CYP3A5*3 allele on the pharmacokinetics of sildenafil,     udenafil, and vardenafil, the clinical trial using a single oral dose was conducted in Korean     healthy male subjects whose genotype of CYP3A5 had been determined.   "
222562|NCT00767611|"     Objectives:      Male factor infertility is poorly understood and our ability to evaluate the male     contribution to a couple's infertility is very limited. The overarching goal of this project     is to understand at the molecular level what functional activities in human sperm are     required for successful fertilization leading to full term development. These findings will     allow us to develop new methods to determine the impact of environmental exposures on sperm     quality and male fertility.      A sperm protein known as phospholipase C zeta (PLC zeta) initiates embryo development at     fertilization. The primary objective of this study is to test the hypothesis that human PLC     zeta activity correlates directly with the proportion of fertilized eggs that undergo early     cleavage during an in vitro fertilization (IVF) cycle. Secondary objectives for the study are     to generate preliminary data regarding the variability in sperm PLC zeta activity within and     between individuals and to determine if there are clinical or laboratory correlates for sperm     PLC zeta activity.      Study population:      The study population will consist of 178 infertile couples undergoing IVF procedures at Duke     Fertility Center (DFC) from which we will obtain 154 evaluable couples for the study.      Overall Design:      An observational cohort study design will be used to assess the association of PLC zeta     activity in the residual sperm from the sample used for an IVF cycle with the proportion of     eggs per couple that undergo early cleavage during the same cycle. Infertile couples     enrolling in an IVF treatment cycle at DFC will be approached for inclusion in the study.     Consent will be obtained from both male and female partners, and historical medical     information and information about their IVF cycle will be collected by chart review. Blood     for isolation of serum and DNA will be collected only from the male partner for evaluation of     hormone levels and genetic analyses related to infertility. On the day of the egg retrieval,     residual sperm not needed for clinical purposes will be transported via courier to NIEHS.     Sperm PLC zeta activity will be measured in the investigator's laboratory using an     experimental bioassay. Sperm PLC zeta protein will be analyzed at the University of     Massachusetts.      Outcome Parameters:      The primary outcome will be the proportion of embryos that undergo early cleavage. Secondary     outcomes will include proportion of eggs fertilized, embryo development parameters, and p...   "
222563|NCT00767624|"     The aim of the proposed three-site study is to increase the rate of full remission from major     depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both     major depressive disorder and insomnia.   "
222564|NCT00767637|"     To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving     dialysis   "
222565|NCT00767650|"     This study will use neuropsychological tests to look at nervous system side effects of     Cyclosporine (CsA) in patients with aplastic anemia. CsA is used as part of an     immunosuppressive regimen in treating severe aplastic anemia. The drug can produce nervous     system side effects, such as tremor and, less commonly, insomnia, anxiety, headache,     confusion or seizures. This study will look at effects of CsA on intellectual ability,     depression, anxiety, attention, concentration, memory, perception, coordination, and thought     processing in patients      Patients 15 years of age or older who have severe aplastic anemia may be eligible for this     study if they:        -  are co-enrolled in a Clinical Center protocol in which they will receive CsA        -  have not taken CsA for 6 months before enrolling in this study      Participants undergo neuropsychological testing. In addition, they provide blood samples and     their clinical data are reviewed for things that may influence the interpretation of findings     from the testing, such as results of blood tests, types of medications taken, number of     transfusions required, etc. The procedures are as follows:      Before first dose of cyclosporine:        -  Patients are asked about prior problems with their nervous system, prior treatment for          their aplastic anemia (including transfusions), prior infections, and current          medications. They then complete the following sets of tests:        -  Battery 1: A set of three tests that measure intellectual ability, level of depression          (if any) and level of anxiety (if any).        -  Battery 2: A set of seven tests that measure changes in the central nervous system and          how these changes affect attention, concentration, memory, perception, coordination, and          thought processing.        -  Patients provide a half teaspoon of blood for this study at the same time blood is          collected for their primary treatment protocol.           6 months and 12 months after starting cyclosporine        -  Patients are asked about treatment for their aplastic anemia (including transfusions),          infections, and changes in medications that have occurred since they started taking          cyclosporine. They then repeat the set of tests in Battery 2.        -  Patients provide a half teaspoon of blood for this study at the same time blood is          collected for their primary treatment protocol.   "
225745|NCT00805948|"     The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent     Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following     U.S. market approval.   "
222566|NCT00767663|"     In this study the investigators will investigate whether a short pretreatment (3-7 days) with     dipyridamole 200mg twice daily will protect patients against myocardial injury sustained     during an elective dotter operation of the coronary arteries (PCI).      The investigators hypothesize that dipyridamole can reduce myocardial injury sustained during     elective PCI.   "
222567|NCT00767676|"     Contact sensitization by patch applications.   "
222568|NCT00767689|"     Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities.     This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which     is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome.     patients , starting capecitabine chemotherapy for their cancer, will participate in this     study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive     either vitamin B6 or a placebo. investigators and patients will be blinded to the     intervention.   "
222699|NCT00754624|"     Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005   "
222569|NCT00767702|"     This study will explore scientists opinions and practices regarding the use of population     descriptors (e.g., race, ethnicity, ancestry, geography and nationality) to describe a     research study population. It will collect genetic researchers opinions, understandings and     experiences studying human genetics and genetic variation.      Scientists who are a principal investigator or co-principal investigator n a human genetic or     genomic study of a common disease with at least preliminary data that uses population     descriptors may be eligible for the study.      Participants are asked to think about their study populations and how they are described in     their research. They participate in two audio-taped semi-structured interviews that last from     about 90 to 120 minutes. They may also participate in one or both of the following optional     study components:        -  A third semi-structured interview that explores implementing a new method of describing          study populations in data analysis.        -  2 to 3 days of lab observation, in which a member of the study research team meets the          lab members, observes daily activities and attends lab meetings.   "
222570|NCT00767715|"     The purpose of this study is to test the efficacy and total costs of olanzapine versus     commonly used conventional antipsychotics in Sweden.   "
222571|NCT00767728|"     The purpose of this study is to compare the maintenance of mild to moderate ulcerative     colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day     versus placebo.   "
222572|NCT00767741|"     The aim of this study is to test the pharmacodynamics of insulin analogs and their dependence     on external and physiological alterations. We plan to compare the pharmacodynamics of insulin     analog delivery in regular conditions and in the presence of increased perfusion of the     delivery site, achieved by way of local warming and movement   "
222573|NCT00767754|"     Panic disorder is one of the most prevalent and disabling psychiatric disorders. Brain     regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus,     parahippocampal gyrus, frontal cortex, and thalamus has been reported to be related with the     pathophysiology and treatment outcome in panic disorder. Paroxetine has been used as primary     agent for treatment of panic disorder but there is little information on how paroxetine     affects the brain function in patients with panic disorder.      The specific aim of this study is to examine the differences in brain activity between     responders and nonresponders and to determine the predictor of paroxetine treatment in     patients with panic disorder in terms of brain activity.   "
222574|NCT00767767|"     People often develop fearful responses to things, but have no conscious control over the     fear. This is a basic form of unconscious memory, called fear conditioning. Intravenous     anesthetic drugs have remarkable effects on conscious memory, but it is unknown whether they     have similar effects on these unconscious fear memories.      To address this question, the investigators will study 114 healthy adult volunteer subjects.     The subject is given a very low dose of an anesthetic drug intravenously (i.e. through the     bloodstream). The dose is so low that the subject might not even be able tell if they are     getting the drug. While they are receiving the drug, the subject will perform a series of     memory tests and a fear conditioning experiment, which are set up like a very simple computer     game. To create the fear response, subjects will occasionally receive a mildly     uncomfortable shock to their arm. The subject is able to determine the highest level of shock     that they will receive.      The investigators are doing this study because the investigators wish to know exactly how the     drugs affect the way people process fear and emotion. This knowledge might one day be used in     the treatment of some psychiatric disorders.   "
222575|NCT00767780|"     The purpose of this study is to examine (retrospectively) the effect of a new biomechanical     device on gait patterns of patients suffering from musculoskeletal disorders. The analysis is     conducted on an existing database of the therapy center.   "
222576|NCT00767793|"     The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic     solution.   "
222577|NCT00767806|"     The purpose of this study is to determine if duloxetine reduces the severity of chronic low     back pain.   "
222578|NCT00767819|"     The purpose of this multicenter, two-arm, exact binomial single-stage, phase II trial is to     determine the preliminary efficacy and safety of RAD001 in patients with histological     evidence of progressive or metastatic bone or soft tissue sarcoma.   "
222579|NCT00767832|"     The purpose of the study is to assess the coagulation changes that occur in patients     undergoing elective Cesarean delivery using thromboelastography (TEG). We will compare     coagulation data to assess potential coagulation changes associated with hemoglobin changes     before and after surgery, and related to estimated blood loss.   "
222580|NCT00767845|"     RATIONALE: Gathering information about symptom management from patients with localized     prostate cancer may help doctors improve patients' quality of life.      PURPOSE: This clinical trial is studying symptom management in African-American men with     localized prostate cancer.   "
222613|NCT00768300|"     The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying     disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to     evaluate its safety, and to evaluate its effect on development of pulmonary hypertension,     quality of life, and dyspnea (shortness of breath) symptoms in this participant population.     Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively.     Participation in the study was to be up to 4 years, depending on how long it would take to     enroll participants and observe study events. After randomization, visits to the clinic took     place every 3 months, and laboratory procedures were performed every month.   "
222595|NCT00768053|"     The Disease Activity Score (DAS) is a system of measurement developed in the 1980s that uses     certain criteria, including joint counts and patient perceived disease activity, to measure     disease activity in people with Rheumatoid Arthritis . More recently, the European League     against Rheumatism (EULAR) has developed a new system of measurement known as the Rheumatoid     Arthritis Impact of Disease score, or EULAR-RAID score. The EULAR-RAID score is a composite     score based on patient reported outcomes, and includes such criteria as pain, functional     disability, fatigue, sleep disturbances, coping, overall assessment of physical well being     and overall assessment of psychological well being. The objective of this study is to     evaluate the practical modalities and performance of the EULAR- RAID score in patients with     rheumatoid arthritis who have been prescribed etanercept as part of usual medical practice.   "
222581|NCT00767858|"     This study will explore how cultural differences influence genetics research in developing     countries. Human genetics research is becoming more common in developing countries. However,     when research is conducted with people living in developing countries, there is a chance that     culture differences can lead to misunderstandings between investigators and participants,     resulting in ineffective research. This study will explore challenges facing investigators     conducting genetics research in developing countries and opportunities to improve this kind     of research.      Scientists who have conducted genetics research in a developing country may be eligible to     participate in this study. Participants are interviewed by telephone. The interview, which     lasts about an hour, includes questions about the researchers decision to conduct the study     they have done, the times they noticed that culture played a role in the research and the     times that were more challenging and less challenging.      The interviews are recorded, transcribed and analyzed for themes related to cultural     congruence and specific challenges and opportunities with regard to cultural congruence.   "
222582|NCT00767871|"     Panic disorder is one of the most prevalent psychiatric disorders and recently abnormal fear     network is known to be implicated in the pathophysiology of panic disorder. The fear network     involves many brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus     coeruleus, parahippocampal gyrus, frontal cortex, and thalamus. Escitalopram, a highly     selective serotonin reuptake inhibitor, is usually effective for panic dis order, but there     is little information on how escitalopram affects the fear network.      The specific aim of this study is to test the following hypotheses using 18F-FDG positron     emission tomography (PET)        1. Patients with panic disorder will show abnormal activity of the fear network compared to          healthy comparison subjects.        2. Patients with panic disorder will show normalized activity of the fear network after          12-weeks of treatment with escitalopram.        3. The changes of fear work after the treatment will be associated with psychological          variables and neurohormones.   "
222583|NCT00767884|"     The purpose of this study is to evaluate the optic nerve head changes consequent to     panretinal photocoagulation done for diabetic retinopathy.   "
222584|NCT00767897|"     The proposed study is a pilot study and a first step towards developing an optimized HPV     vaccination strategy for girls who have CKD, or are on dialysis or have a kidney transplant.   "
222585|NCT00767923|"     Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level     amputation because of critical limb ischemia, infection, or tissue necrosis.   "
222586|NCT00767936|"     Adult liver cancer is the third leading cause of cancer deaths worldwide. The major risk     factor for liver cancer is hepatitis B virus (HBV) infection. The purpose of the study is to     sequence the HBV genome in patients with chronic HBV infection, and in patients with liver     cancer resulting from chronic HBV infection. The goal is to identify mutations in the HBV     genome that predisposes these high risk individuals to the development of liver cancer.   "
222587|NCT00767949|"     Age-related macular degeneration (AMD) is a disease that, in time, destroys the macula, which     is the central part of the retina that gives sharp central vision. The primary purpose of     this study is to assess the safety of iSONEP which is a humanized monoclonal antibody against     a bioactive lipid, sphingosine 1-phosphate (S1P).   "
222588|NCT00767962|"     Treatment of recurrent primary spontaneous pneumothorax remains controversial and many     therapeutic options exist. The aim of this study is to compare pleural symphysis by talc     poudrage during medical thoracoscopy and surgical management combining pleural abrasion and     blebs or bullae resection for treatment of recurrent primary spontaneous pneumothorax.   "
222589|NCT00767975|"     LTBI Treatment is effective in prison   "
222590|NCT00767988|"     Girls with spina bifida also have bladder problems. This is because they need temporary     placement of a tube into the bladder to remove urine. This thin flexible tube is called a     catheter. It can increase the risk of having bacteria in the urine. This in turn can lead to     urinary tract infection (UTI).      Some girls with spina bifida are given antibiotics. These are medicines used to treat     infections caused by bacteria. The medicine is used to prevent UTI. However, long-term     treatment with these medicines can have side effects. For example, the bacteria may become     resistant to the antibiotics. Also, bacteria in the urine can persist. UTI can still occur in     patients on antibiotics.      UTI in girls occurs because bacteria migrate from the rectum to the vagina area. This gives     the bacteria access to the bladder. Also, in girls with spina bifida, the access to the     bladder is easier because of the catheter.      Probiotics are friendly bacteria. They are available as dietary supplements and as food. They     contain helpful bacteria. Yogurt is an example of a food that contains probiotics.      The purpose of this study is to find out, if probiotics taken for 6 months can prevent UTI in     girls with spina bifida. We will also try to find out whether changes in urine bacteria are     associated with the taking of the probiotics. A vaginal and rectal swab will also be done to     find out if taking probiotics has any benefits on preventing bacteria.   "
222591|NCT00768001|"     Liver cancer is a leading cause of cancer deaths worldwide. While the molecular pathogenesis     of liver cancer has been extensively studied, less is known about how the molecular biology     of liver cancer influences clinical outcome and treatment response. We are developing a     translational research program that will characterize molecular changes in liver cancer. We     plan to use molecular information obtained from studying liver tumor tissues to develop new     diagnostics and treatment regimens for patients with these cancers. The experimental approach     will require freezing fresh tumor tissues obtained from surgical procedures, which will be     subsequently used for analysis of DNA, protein and mRNA expression. Many patients with liver     cancer are referred to the Stanford Liver Tumor Board for consultation and treatment     recommendations. We propose to gather tissue samples from those who subsequently undergo     biopsy, liver resection surgery, or transplant surgery.   "
222592|NCT00768014|"     The purposes of this study is to integrate the objective tests into the subjective test,     visual analog score (VAS), for evaluation and further understanding of relieving labor pain     by TENS application on acupuncture points in the first stage of labor.   "
222593|NCT00768027|"     The objective is to define patient eligibility for hyperbaric oxygen therapy and to evaluate     wound healing progression using a new hyperspectral imaging technology.   "
222594|NCT00768040|"     To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema   "
222596|NCT00768066|"     The technique of transplanting progenitor cells into a region of damaged myocardium, termed     cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or     repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily     available, easy to culture to ensure adequate quantities for transplantation, and able to     survive in host myocardium; often a hostile environment of limited blood supply and     immunorejection. Whether effective cellular regenerative strategies require that administered     cells differentiate into adult cardiomyocytes and couple electromechanically with the     surrounding myocardium is increasingly controversial, and recent evidence suggests that this     may not be required for effective cardiac repair. Most importantly, transplantation of graft     cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a     number of candidate cells have been transplanted in experimental models, including fetal and     neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile     grafts, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac     precursors residing within the heart itself. There has been substantial clinical development     in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both     post-infarction patients, and patients with chronic ischemic left ventricular dysfunction and     heart failure. The effects of bone-marrow derived mesenchymal stem cells (MSCs) have also     been studies clinically.      Currently, bone marrow or bone marrow-derived cells represent highly promising modality for     cardiac repair. The totality of evidence from trials investigating autologous whole bone     marrow infusions into patients following myocardial infarction supports the safety of this     approach. In terms of efficacy, increases in ejection fraction are reported in the majority     of the trials.      Chronic ischemic left ventricular dysfunction resulting from heart disease is a common and     problematic condition; definitive therapy in the form of heart transplantation is available     to only a tiny minority of eligible patients. Cellular cardiomyoplasty for chronic heart     failure has been studied less than for acute MI, but represents a potentially important     alternative for this disease.   "
222597|NCT00768079|"     The study will evaluate the effect of two IV dose regimens of MEDI-563 on the proportion of     adult subjects with asthma exacerbations who required an urgent healthcare visit for     treatment of an acute asthma exacerbation.   "
222598|NCT00768105|"     The purpose of this study is to assess safety and tolerability of AZD1656 after multiple     repeated oral doses in patients with type 2 diabetes on top of insulin.   "
222599|NCT00768118|"     RATIONALE: Studying samples of blood and urine from healthy participants receiving     antioxidant nutritional supplements may help doctors identify changes in biomarkers related     to oxidative stress.      PURPOSE: This clinical trial is studying how well a nutritional supplement capsule containing     curcumin, green tea extract, Polygonum cuspidatum extract, and soybean extract works in     healthy participants.   "
222600|NCT00768131|"     The purpose of this study is to determine if EGFR status (positive or negative) by FISH can     predict response to cetuximab therapy in NSCLC patients treated with carboplatin and     paclitaxel   "
222601|NCT00768144|"     The purpose of this study is to determine the effectiveness of sunitinib on participants with     ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may     stop cancer cells from growing by blocking the blood supply to the tumor.   "
222602|NCT00768157|"     Most hepatocellular carcinomas are associated with hepatitis B virus, it is hypothesized that     anti-viral treatment may be helpful in treating HBV-related hepatocellular carcinoma.   "
222603|NCT00768170|"     This study evaluates the safety, tolerability and pharmacokinetics (PK) of MK0633 in     adolescent mild-to-moderate Japanese asthma patients to permit further clinical investigation   "
222604|NCT00768183|"     The objective of this study was to compare the single-dose relative bioavailability of     Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate extended-release     capsules when dosed with alcohol under fasting and fed conditions compared to water.      In addition, the pharmacokinetics of an immediate release solution following a 20 mg dose was     assessed for informational purposes and for possible modeling.   "
222605|NCT00768196|"     The purpose of this study is to asses the EED symptom prevalence in Koran GERD patients with     typical reflux symptom and to evaluate quality of life with the scales including Gerd Q.   "
222606|NCT00768209|"     This study is designed to determine the effects of a single dose of the study medication in     subjects with and without hepatic impairment. 18 to 24 subjects will participate by having     multiple blood draws taken to measure the level of study medication in their blood over time.   "
222607|NCT00768222|"     This is a 90-day study to evaluate cosmetic outcome and Surgical Site Infection in     approximately 100 patients from 6 centers in China undergoing scheduled modified radical     mastectomy for breast cancer.   "
222608|NCT00768235|"     This study tested the hypothesis that yoga practice can improve respiratory function in the     elderly.   "
222609|NCT00768248|"     The purpose of this research study is to determine if putting local anesthetic—or numbing     medication—through one or two tiny tube(s) placed next to the nerves that go to an amputated     limb will decrease phantom limb and/or stump pain.   "
222610|NCT00768261|"     The overall purpose of this research is to determine if there is a relationship between your     symptoms of Dementia of the Alzheimers type and changes in the size and shape of certain     brain structures during combined Donepezil (Aricept®) and Memantine (Namenda®) treatment.   "
222611|NCT00768274|"     The purpose of this study is to investigate an oral formulation of RVX000222 for safety,     pharmacokinetic and efficacy in healthy subjects.   "
222612|NCT00768287|"     To evaluate the safety (acute effects associated with infusions, and inhibitor development),     pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding during prophylaxis     and with respect to control of hemorrhaging in both the prophylaxis and on demand groups of     IB1001 in subjects with hemophilia B.   "
222631|NCT00768534|"     Describe the patient population and bacterial microbiology of pediatric patients presenting     with spontaneous draining acute otitis media   "
223334|NCT00774059|"     The study is using a new breast lift system to complement a breast-lift operation.      In general there will be recurrence of breast-ptosis after a correcting operation.      With this device we want to minimize this recurrence and provide an internal bra.   "
222614|NCT00768313|"     There has been a growing trend amongst surgeons to use a construct for correction of     scoliosis which involves segmental instrumentation with pedicle screws. Pedicle screw     proponents cite greater curve control in all planes, which results in improved spinal curve     correction. Some surgeons have noted due to the increased strength of the all screw     construction that the rod is now the weak part of the spinal fixation. Although no evidence     has been raised in regards to hardware failure there is a perception that a loss of balance     in the sagittal plane is the result of flex in the titanium rod. A novel solution to the     issue of rod flexibility is raised with the expedium super steel instrumentation which allows     for greater stiffness than a 5.5 mm titanium rod with the same lower profile. This study aims     to compare the new super steel technology with other established instrumentations used to     correct spinal stenosis.   "
222618|NCT00768365|"     Between September 2006 and September 2008, 35 patients (32 women and 3 men; mean age 49years     with adrenal incidentaloma (AI) were prospectively evaluated at the Department of     Endocrinology and General Surgery of Istanbul University, Istanbul Medical Faculty.      All patients with AI underwent physical examination, including waist circumference. Body mass     Index (BMI) was calculated as weight (kg)/ height (m) squared. A BMI > 30 was considered an     index of obesity. A waist circumference > 88 cm in women and > 95 cm in men was considered     the cutoff for visceral obesity in accordance to the Adult Treatment Panel III (ATP III)     metabolic syndrome criteria. Systolic blood pressure (SBP) and diastolic blood pressure (DBP)     were measured from the right brachial artery of the patients in a supine position after 10     minutes of rest by using a pneumatic sphygmomanometer by the same doctor.   "
222619|NCT00768378|"     The purpose of this study is to assess the safety and efficacy of the BrainPort balance     device in improving balance and gait as measured by clinically accepted standardized balance     assessments in subjects with peripheral vestibular dysfunction.   "
222620|NCT00768391|"     The purpose of this study is to determine if IMC-3G3 is safe for patients, and also to     determine the best dose of IMC-3G3 to give to patients.   "
222621|NCT00768404|"     VI-0521, a fixed dose combination of immediate-release (IR) phentermine and     controlled-release (CR) topiramate, is in Phase III clinical development as a potential     therapy for obesity. In human, both phentermine and topiramate are primarily cleared by renal     excretion. The contribution of hepatic metabolism to elimination of phentermine and     topiramate is not significant. Obese patients, the proposed indicated population for future     treatment with VI-0521, are likely to have renal impairment. Therefore, this study is     important in understanding the effect of renal impairment on the pharmacokinetics of     topiramate and phentermine in subjects with renal impairment compared to subjects with normal     renal function.   "
222622|NCT00768417|"     Evidence indicates that almond consumption is associated with multiple health benefits.     However, nuts are commonly excluded from diets on the basis that their high energy content     may induce weight gain. Evidence from numerous studies show that this is not the case, yet     the mechanism responsible for the less than predicted effect on weight is unknown. This study     aimed to examine the effects of increased mastication on lipid bioavailability and satiety     related peptide released in humans. Its purpose is to provide valuable mechanistic data to     support the results from previous completed clinical studies.   "
222623|NCT00768430|"     Existing treatments for major depressive disorder (MDD) generally take weeks to months to     exert their maximal benefit. There is an urgent need to develop rapid-acting treatments for     MDD. Ketamine, a high-affinity N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, has     been used as a standard intravenous (IV) anesthetic agent for many years in both pediatric     and adult patients. Beyond its well-established role in anesthesia and pain management, there     is emerging evidence that ketamine may have rapid antidepressant properties for patients with     severe mood disorders.      In this study we are investigating whether ketamine can have an antidepressant effect     compared to midazolam. Midazolam has similar anesthetic effects compared to ketamine but has     not been shown to be an antidepressant, and is therefore acting as an active control in this     study.      The study period can last up to 8 weeks, depending on your response to the study medication.     There are two required overnight stays in our Research Commons as part of this study.   "
222624|NCT00768443|"     This a non-interventional multi-centre study to evaluate the symptom load and management     strategies in PPI-treated GERD patients with persistent GERD symptoms..   "
222625|NCT00768456|"     The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 %     vs. Placebo in patients undergoing vaginal hysterectomy.      The hypothesis is that systematic local infiltration will reduce postoperative pain and     postoperative opioid consumption.   "
222626|NCT00768469|"     This is an open-label, phase 1 study of ascending multiple oral doses of HKI-272 in     combination with paclitaxel.   "
222627|NCT00768482|"     This study will measure the amount of buprenorphine found in the blood after taking     sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine     implants).   "
222628|NCT00768495|"     This trial will collect tissue oxygenation data via hyperspectral imaging before and after     endovascular procedures.   "
222629|NCT00768508|"     This study would like to test whether the combination of ondansetron and naltrexone will be     superior to either medication alone or placebo in the treatment of alcohol dependence.   "
222630|NCT00768521|"     This study will design an alternative urodynamic platform to better evaluate treatment     effects of medications for overactive bladder. Part II is dependent on results of Part I and     may not be conducted.   "
222632|NCT00768547|"     The study has three main parts.        1. To see if we can develop a riskstratification tool that can be used to asses the risk          for acutely admitted medical patients for inhospital death, admission to the ICU and          death within 30 days of release.        2. To test existing tool as in 1.        3. To clarify if it is most reasonable to let the admitting doctor order blood test by          clinical judgment or be using a predefined list of tests.   "
222633|NCT00768560|"     This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who     meet the entry criteria will be required to stop taking any other anti-hypertensive agents     than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label     Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those     who are confirmed with their eligibility as subjects for the present study at the end of the     baseline treatment period will be randomly allocated to one of the 6 treatment sequences on     the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg     OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks     per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR     tablet 40 mg and its placebo as follows (Double-blind treatment period).   "
222634|NCT00768573|"     taste of formulation   "
222700|NCT00754637|"     The purpose of this prospective clinical data-collection is to document the performance and     clinical outcomes of the Microplasty Tibial Tray.   "
222886|NCT00770354|"     The aim of this study is to compare the overall tumour response rate per RECIST in     postmenopausal women with metastatic or locally advanced breast cancer receiving AS1402 in     combination with letrozole compared to letrozole alone   "
222635|NCT00768586|"     The aim of this study is to collect data on the early visual development of extreme premature     infants. The method is the measurement of flash visual evoked potentials and the study     population includes premature infants under the 28th weeks of gestation, who have normal     cranial ultrasound examinations, normal aEEG, no clinical neurological symptoms and who have     a normal ophthalmological status.      fVEP measurements were recorded from the first week of life every second week until term.      The fVEP recordings were performed in active sleep, in stable premature infants, who were     continuously monitored. The Nihon Kohden Neuropack 8 was used, the stimulus frequency was 0,5     Hz, artefact free averages were analyzed.      The measurements were analyzed according to the presence and absence of known waveforms,     their latencies and amplitudes. Longitudinal analysis was performed to analyse the effect of     extrauterine visual development on fVEP with growing gestational ages.   "
222636|NCT00768599|"     This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up     period) of a topical foam to treat athlete's foot. The active ingredient in the foam --     econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your     doctor can currently prescribe to treat athlete's foot. This study will help to understand if     the foam works the same as the cream to treat athlete's foot.   "
222637|NCT00768612|"     This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese     subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also     assess the efficacy of vabicaserin and compare it to risperidone.   "
222638|NCT00768625|"     The purpose of this study is:        1. To determine the frequency of cardiovascular diseases in patients with OSA, obese,          overweight, and lean (BMI<25)        2. To analyze the CPAP treatment over the clinical evolution of OSA patients        3. To determine if OSA is a independent predictor of cardiovascular risk   "
222639|NCT00768638|"     Randomized controlled double blind study of parallel groups to evaluate the comparative     effects of low-dose of atorvastatin on proteinuria in patients with stage 3 or 4 chronic     kidney disease.   "
222640|NCT00768651|"     We aim to study if the administration of medications to increase the secretion of hormones     from the intestines can improve glycemic control, reduce insulin use and promote β-cell     regeneration/expansion in subjects with type 1 diabetes following islet transplantation who     are back using small doses of insulin because of early graft dysfunction. We believe that the     results will enable us to understand whether these drugs could be useful in islet transplant     recipients, particularly if glycemic control deteriorates.   "
222641|NCT00768664|"     This study will investigate the safety and efficacy of oral PF-00299804 in patients who have     not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck     squamous cell cancer.   "
222642|NCT00768677|"     This is a study of topiramate to see whether topiramate decreases binge eating behavior among     adolescents and young adults. The investigators did also checked whether topiramate affected     cognitive function or not.   "
222643|NCT00768690|"     The purpose of this study is to determine multiple dose safety, tolerability and     pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to     determine the effect of single dose administration of ketoconazole on steady state ABT-333     pharmacokinetics   "
222644|NCT00768703|"     Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of     the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm.     Herniation of viscera into the chest prevents the fetal lungs from developing and growing to     normal size. In the most severe cases, there is significant morbidity and mortality at birth.     For these fetuses, fetal intervention may improve outcomes by enabling the lungs to grow     enough in utero that they are capable of sustaining life after birth. This unblinded,     non-randomized trial will assess the safety and efficacy of the use of the Goldvalve balloon     and MiniTorquer microcatheter to perform percutaneous temporary tracheal occlusion to treat     severe CDH in utero. The primary outcome variable will be fetal lung growth due to successful     'plugging/unplugging' of the trachea, as determined by serial lung-head ratio (LHR)     measurements. Secondary outcome variables include maternal, fetal and neonatal variables,     specifically neonatal survival at 90 days of life. For infants who survive beyond 90 days     post-delivery, their families will be offered follow-up (up to 2 years of age and possibly     beyond) in the Long-term Infant-to-Adult Follow-up Evaluation (LIFE) Clinic at UCSF.   "
222660|NCT00768911|"     Rationale:      In light of the demonstrated activity of anti-angiogenesis agents in rGBM, it is reasonable     to postulate that adding these agents to standard RT and chemotherapy in the up-front     management of newly diagnosed GBM may improve the clinical benefit. This study will examine     the safety and tolerability of adding CT-322 to the standard radiation therapy/temozolomide     (RT/TMZ) backbone of treatment for newly diagnosed GBM   "
222661|NCT00768924|"     The CopiOs Bone Void Filler (BVF) is a synthetic bone graft material consisting of calcium     phosphate dehydrate within lyophilized type I bovine collagen that has been formed into pads     of various sizes for surgical implantation. Pre-clinical animal studies suggest that the bone     healing strength of CopiOs to be equivalent to autograft.   "
222645|NCT00768716|"     Although acetaminophen is the most commonly used nonprescription drug in the USA, little is     known regarding the influence of genes and race/ethnicity on acetaminophen disposition. The     investigators long-term goal is to understand the causes of differences in acetaminophen     disposition between people that are the result of genetic variation and ethnicity and may     predispose individuals to a higher risk of acetaminophen hepatotoxicity. The aim of this     particular study is to measure the rate of elimination of acetaminophen via the 3 main     pathways (glucuronidation, sulfation and oxidation) in self-identified White-Americans     (n=100) and African-Americans (n=100). These rates will then be correlated with selected     genetic polymorphisms in genes encoding enzymes involved in acetaminophen metabolism. Two     main hypotheses will be tested: 1. African-Americans eliminate acetaminophen more rapidly by     glucuronidation than do White-Americans. 2. Elimination via glucuronidation, sulfation, and     oxidation in subjects will be significantly correlated with the presence of polymorphisms in     the UGT1A6, SULT1A1, and CYP2E1 genes, respectively.   "
222646|NCT00768729|"     Kidney transplantation is widely considered to be the treatment of choice for children with     End Stage Renal Disease (ESRD). The purpose of this study is to determine the safety of     sirolimus monotherapy for long-term immunosuppression in children and adolescents after     kidney transplantation.   "
222649|NCT00768768|"     Terbinafine is recognized as one of the most effective drugs for the treatment of toe nail     fungus (onychomycosis). This trial will be the first test of a new device to improve the     delivery of terbinafine directly to the toe nail. The device uses a low level of electric     current, iontophoresis, to push the terbinafine into the nail.      The study will involve a single application of terbinafine, in a gel form, with the     iontophoretic device. The treatment will be applied to the surface of both large toenails of     healthy subjects. Subjects will be asked to report any sensations in the nail or surrounding     skin experienced during or after treatment. Samples from the edge of the treated toe nail     will be taken at 2-4 week intervals to measure how much terbinafine was delivered to the     nails, and blood samples will be taken for the first 24 hours after treatment to determine     how much, if any, terbinafine was absorbed into the subjects's body. Observations will also     be made of the treated toes to look for any irritation of the surrounding skin due to the     treatment.   "
222650|NCT00768781|"     The overall goal of this project is to evaluate the evidence for the efficacy of two     mindfulness-based interventions, mindfulness-based therapy for insomnia (MBT-I) and     mindfulness-based stress reduction (MBSR), for reducing arousal and improving sleep among     individuals with psychophysiological insomnia.      Specific Aim 1: To obtain evidence for the relative effects of MBT-I and MBSR compared to a     delayed-treatment control condition followed by behavior therapy for insomnia (BT-I) on     arousal levels. It is hypothesized that MBSR and MBT-I will be superior to the control     condition at reducing arousal levels.      Specific Aim 2: To obtain evidence for the relative effects of MBT-I, MBSR, and the     delayed-treatment control on sleep. It is hypothesized that MBT-I will be superior to the     MBSR and control conditions at improving sleep parameters.      Specific Aim 3: To investigate the relationship between measures of arousal (self-report and     objective measures) and sleep (self-report and objective measures) to enhance the     understanding of the role of arousal in psychophysiological insomnia.   "
222651|NCT00768794|"     The purpose of this study is to determine the effectiveness of using acidophilus to treat     oral candidiasis (thrush) caused by radiation therapy to the head and neck region.      This study will conducted in two parts. In the first part of the study, two participants will     begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy,     white/yellow coating and/or patches on the tongue and inside of your mouth that are painful,     you will begin taking acidophilus capsules twice each day until the last day of radiation     therapy.      The second part of the study is to determine if acidophilus is effective in preventing oral     candidiasis (thrush) during radiation therapy to the head and neck region. In the second part     of the study three participants will take acidophilus capsules twice each day beginning on     the first day of radiation therapy and continuing until the last day of radiation therapy.   "
222652|NCT00768807|"     The purpose of this study is to determine whether patients with obstructive sleep apnea have     any changes in left ventricular function and structure after 06 months of continuous positive     airway pressure treatment.   "
222653|NCT00768820|"     The purpose of this study is to investigate the Psychiatric and Cognitive Phenotypes in     Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome     Characterization, Treatment and Examining the Connection to Developmental and Molecular     Factors   "
222654|NCT00768833|"     The purpose of this study is to assess the prevalence of pneumococcal stereotypes in the     nasopharynx of healthy children and to describe the changes of nasopharyngeal carriage at     different ages over time.   "
222655|NCT00768846|"     The zotarolimus-eluting Endeavor Resolute stent is not inferior to the everolimus- eluting     Xience V stent platform regarding a composite of cardiac death, myocardial infarction or     target lesion revascularisation in a real-world population.   "
222656|NCT00768859|"     To determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as     neo-adjuvant treatment in patients with stage II or III HER2 positive breast cancer   "
222657|NCT00768872|"     The purpose of this study is to characterize a patient's activity levels before and after     spinal cord stimulation therapy.   "
222658|NCT00768885|"     To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.   "
222659|NCT00768898|"     The purpose of this study is to determine the correct volume of lissamine green to use when     assessing conjunctival staining, and to determine the time course needed to evaluate     conjunctival staining after lissamine green has been instilled in the eye.   "
222691|NCT00769314|"     To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal     tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.   "
222662|NCT00768937|"     Hepatocellular carcinoma (HCC) as the third most common cause of cancer-related death has a     very poor prognosis. Aim of this open label single arm non randomized pilot trial is the     evaluation of the efficacy and safety of sorafenib in combination with TACE in patients with     unresectable HCC. Efficacy ad safety will be compared with a historical TACE-only group of a     placebo controlled TACE-trial.   "
222663|NCT00768950|"     Up to 60% of patients with Seronegative Spondyloarthritides have inflammation in the colon or     ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will     develop. Lesions of the bowel could also be present in the SA patients because of the     potential injury posed by the NSAIDS, a common used medication in this setting.      It is the bowel involvement in patients with SA that we propose to characterize, partly     because there are scant communicated data in the medical literature, especially regarding     small bowel lesions.   "
222664|NCT00768963|"     The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab     given via subconjunctival injection in patients undergoing pterygium surgery.   "
222665|NCT00768976|"     The primary objective of this study is to evaluate the quality of the clinical trial     experience of cancer patients participating in cancer research studies through Summa Health     System Hospitals Cancer Research Program by evaluating patient satisfaction regarding reasons     for participating, facility, consent and treatment, personal issues and overall assessment.      The secondary objective of this study is to determine areas for improvement to make the     patient's clinical trial experience a satisfying and positive journey.   "
222666|NCT00768989|"     The purpose of this study is to determine if the combination of atazanavir and raltegravir     taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).   "
222668|NCT00769015|"     This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL     (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent     depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative     intervention, a low vision occupational therapist collaborates with a low vision optometrist     to develop and implement a care plan based on a subject's vision status, rehabilitation     potential, and personal rehabilitation goals. An independent rater masked to treatment     assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and     targeted vision function and vision-related quality of life (secondary outcomes) at baseline     and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months     to evaluate long-term effects.   "
222669|NCT00769028|"     To study the safety and tolerability of a hyperimmune goat serum product (AIMSPRO) in the     treatment of systemic sclerosis (SSc) through a period of 26 weeks of study participation.     The secondary objective of the study is to assess the efficacy of AIMSPRO as a therapeutic     agent for SSc using inter alia the SSc-HAQ questionnaire and the modified Rodnan skin score.   "
222670|NCT00769041|"     This study is to assess whether treatment with a therapeutic (100 mg) or supratherapeutic     (800 mg) dose of avanafil has the potential to cause QT/QTc prolongation in healthy     volunteers.   "
222671|NCT00769054|"     The purpose of this study is to compare systematic local infiltration with ropivacaine or     placebo in patients undergoing repair of posterior vaginal wall prolapse.      The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.   "
222672|NCT00769067|"     This study will compare PF-00299804 given orally on continuous schedule to the approved drug,     erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy;     patients will be randomized to receive one of these drugs, and followed for efficacy and     tolerance of each.   "
222673|NCT00769080|"     The purpose of this study is to compare the 1-year adherence to upfront adjuvant AI for     postmenopausal, early stage breast cancer in the two observational arms; Standard Treatment     and Standard Treatment plus PSP arm after one year   "
222674|NCT00769093|"     The purpose of this study is to learn more about imaging changes induced by a new therapeutic     agent, bevacizumab with the standard steroid, dexamethasone in patients with high grade     glioma. Magnetic resonance imaging (MRI) will be used to evaluate the difference between the     2 treatments. The usual contrast agent (gadolinium) and an iron containing contrast agent     called ferumoxytol may help us to evaluate the differences between bevacizumab and     dexamethasone effects on imaging of a brain tumor called high grade glioma. For this purpose,     after intravenous contrast agent injection, special MR scans (called: dynamic perfusion,     blood-brain barrier (BBB) permeability measurement) will be performed to see the     microvascular changes in the brain and tumor.   "
222675|NCT00769106|"     Study hypothesis:      The recurrence rate of HCC patients after radical resection is about 60-70%. This study is     based on the hypothesis that CIK treatment could decrease the recurrence rate by 15% to 20%.      Abstract:      This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who     underwent radical resection will be included. The patients will be randomized to group A     (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer     treatment after resection of HCC, and the randomize ratio will be 1:1.      Study treatment:      Patients in group A will receive 4 cycles of CIK treatments within 3 months after their liver     resection. Patients in group B will have no anti-cancer therapy. Anti-virus and other     supportive therapies are available in both groups.   "
222676|NCT00769119|"     The purpose of this study is to investigate if treatment with AZD9668 for 28 days is     effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance     which does not have any action).   "
222677|NCT00769132|"     The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER     niacin, laropiprant, and placebo over the course of seven days on urinary levels of a     metabolite of thromboxane A2 (TxA2), as a marker of in vivo platelet reactivity.   "
222678|NCT00769145|"     The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab     given via subconjunctival injection in patients undergoing corneal transplantation.   "
222679|NCT00769158|"     We propose to conduct an inpatient pilot study to test the safety and potential efficacy of     topiramate and naltrexone in combination for the treatment of alcoholism.   "
222680|NCT00769171|"     The purpose of this study is to assess the safety and efficacy of intravenous administration     Moxifloxacin (BAY 12-8039) compared to intravenous ceftriaxone and metronidazole for the     treatment of patients with complicated intra abdominal infections. In view of the fact that     intra abdominal infections are typically polymicrobial and are often treated empirically, the     selected antibacterial agent must cover the likely spectrum of bacterial pathogens.     Combination antibiotics therapy has been widely used with great success.   "
222681|NCT00769184|"     This is a 12 week bilateral study, consisting of 6 weeks of treatment and 6 weeks of     follow-up. The purpose of the study is to compare the safety and effectiveness of combining     and then following a high potency topical corticosteroid treatment with LCD treatment for     moderate-to-severe localized plaque psoriasis.   "
222682|NCT00769197|"     Hypothesis: Children born prematurely (between 8 and 9 months) with brain damage have an     abnormal appearance of the optic nerve (nerve in eye) that resembles glaucoma (cupping)     compared to those born before 8 months.      Purpose: to see how often children who are born prematurely and have suffered brain damage,     have abnormal appearance of the optic nerve (nerve in the eye) which mimics glaucoma     (cupping). This optic nerve cupping is most often seen when children are born after 8 months     and is rarely seen in children born before 8 months.      Children born prematurely are known to have injuries to their brain as they are not yet fully     developed. This often involves the part of the brain that involves vision. Clinicians have     observed that these children have an abnormal appearance of the optic nerve (nerve in the     eye), which has the appearance of glaucoma. These children often undergo extensive and often     unnecessary invasive tests to rule out glaucoma. The investigators wish to establish the     prevalence of this abnormality so that children are not subjected to unnecessary     investigations. The investigators also want to understand how the optic nerve cupping     (similar clinical picture as glaucoma) is related to the approximate timing and extent of the     brain injury, the type of cerebral palsy and the motor disability of these children.   "
222683|NCT00769210|"     Our proposed research will examine whether treatment with simvastatin alters expression and     activity of monocyte TF, whether polymorphisms in the TF gene alter the therapeutic effect     and what effect treatment has on inflammatory markers in heart failure. The results of this     study may assist in tailoring statin therapy to specific characteristics, such as     inflammatory state, of heart failure patients. If treatment with simvastatin significantly     lowers TF expression, this may reduce the risk of thromboembolic events in patients with     heart failure, thus reducing mortality and morbidity. If the treatment effect varies based on     the TF genotype, this may define an identifiable population in whom statin therapy may be     more beneficial than the population as a whole.   "
222684|NCT00769223|"     RATIONALE: Gathering information about the Gleason score, prostate-specific antigen (PSA)     level, and cancer stage from patients who have undergone radiation therapy for prostate     cancer may help doctors predict how patients respond to treatment and help plan the best     treatment.      PURPOSE: This clinical trial is studying the Gleason score, PSA level, and cancer stage in     predicting outcome in patients who have undergone radiation therapy for localized prostate     cancer.   "
222685|NCT00769236|"     We propose to study the intestinal secretion of ASCA by evaluating them in biopsy culture     supernatants from a cohort of patients suffering from CD (n=80) and a cohort of control     patients (UC (n=40) and patients without IBD (n=40 )).   "
222686|NCT00769249|"     RATIONALE: Gathering information about the positive changes in quality of life of older     patients with cancer and their care givers may help doctors learn more about the disease and     plan better treatment.      PURPOSE: This research study is looking at positive changes in the quality of life of older     cancer patients and their caregivers.   "
222687|NCT00769262|"     Preterm newborns typically must be thermally regulated. In the United States, isolettes     (incubators) are used to help them maintain their temperature. Traditionally, the temperature     support (i.e. the temperature of the incubator) is decreased slowly according to NICU     protocol until the baby is able to maintain its temperature in an open crib, without regard     to the status of its feedings. This study will attempt to determine if there is a difference     in length of stay, weight gain, and calories needed to gain appropriate weight between a     group of newborns whose isolette temperatures are decreased in an aggressive strategy     (isolette temperatures are decreased based only on baby's body temperature), and a group of     newborns whose isolette temperatures are decreased in a conservative strategy (isolette     temperatures are decreased to a minimum temperature and then kept steady until their feeds     are at caloric goal and they are taking at least half of their feeds by mouth).   "
222688|NCT00769275|"     Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with     Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5     years for the occurrence of cardiac death or non-fatal myocardial infarction.      The aims are:        1. To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic          subjects with Type 2 Diabetes Mellitus.        2. To identify on the basis of clinical and/or biochemical variables in a high-risk cohort          in which screening for coronary artery disease is appropriate.        3. To assess progression of (silent) myocardial ischemia after 3 years.        4. To assess the occurence of cardiac death or nonfatal myocardial infarction during 5          years follow-up in screened and not screened subjects.   "
222689|NCT00769288|"     Drugs used in chemotherapy, such as FAU, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. This phase I trial is     studying the side effects and best dose of FAU in treating patients with advanced solid     tumors or lymphoma.   "
222690|NCT00769301|"     The complexity of cancer patients' symptoms and health problems constitutes considerable     distress and burden for patients and their family caregivers. To help them manage the illness     effectively, there is a need to better understand the complexity of symptoms and symptom     clusters in patients and caregivers. Therefore, the purpose of this research is to explore a     set of important fundamental research questions to advance the scientific knowledge of cancer     patients' and caregivers' symptoms, symptom clusters and health-related quality of life. The     investigators will follow 500 cancer patients and their caregivers with repeated measures     over 6 months to assess their symptoms, symptom clusters, and quality of life over time.     Caregiver burden will also be examined in the caregivers.   "
222692|NCT00769327|"     RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth.      PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib     mesylate works in treating patients with early chronic phase chronic myelogenous leukemia.   "
222693|NCT00769353|"     This research will examine the impact of brain activity, cognitive processing immune     functioning, and gastrointestinal functioning on depressive symptoms and response to a     psychotherapeutic intervention in youths with Inflammatory Bowel Disease (IBD).   "
222694|NCT00769366|"     Psychosocial factors play an important role in the pathophysiology of acute myocardial     infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary     treatment of AMI consisting of medical and interventional therapy.      The investigators have designed a randomized, controlled study to assess the effects of     short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an     emergency percutaneous coronary intervention (PCI) post-AMI.   "
222696|NCT00769392|"     This study is designed to compare four currently used types of anesthesia used for     intravitreal injection in order to evaluate the most effective method of anesthesia in     reducing pain and discomfort associated with intravitreal injections.   "
222697|NCT00769405|"     RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. It is not yet known whether systemic chemotherapy is more     effective with or without intraperitoneal chemohyperthermia in treating patients with     peritoneal carcinomatosis from colorectal cancer.      PURPOSE: This randomized phase III trial is studying systemic chemotherapy to see how well it     works compared with or without intraperitoneal chemohyperthermia in treating patients     undergoing surgery for peritoneal carcinomatosis from colorectal cancer.   "
222698|NCT00769418|"     This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of     once-daily multiple-dose administration of odanacatib (MK0822).   "
222701|NCT00754650|"     This single arm study evaluated the bone marrow response, safety, and tolerability of 6     months treatment with Avastin (bevacizumab) monotherapy in patients with chronic lymphocytic     leukemia. Patients received 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with     6 months of follow-up.   "
222702|NCT00754663|"     Exercise therapy has proven to be an effective additive therapy in patients with     cardiovascular diseases. The prognostic value of physical activity is well established in     patients with congestive heart failure. Therefore the investigators assumed that the     population of patients with implantable cardioverter-defibrillators (ICD) with impaired left     ventricular function may also benefit from a cardiovascular training in terms of improved     quality of life and reduction of ventricular arrhythmia. The data on feasibility, risk and     therapeutic effects of exercise training are very limited or not available.      This prospective randomized study examines the feasibility and benefits of exercise therapy     in patients with ICD and congestive heart failure.   "
222703|NCT00754676|"     The prospective sham randomized study will evaluate the role of endoscopic stenting     inpatients with chronic pancreatitis and chronic abdominal pain.   "
222704|NCT00754689|"     The primary objective of the study is to demonstrate superiority of rimonabant/metformin     combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single     agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9     months.      The secondary objective is to investigate the effects of rimonabant/metformin combinations     for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density     Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months.      Another objective is to evaluate the safety of rimonabant in combination with metformin over     a period of up to 52 weeks.   "
222705|NCT00754702|"     The purpose of this study is to evaluate the safety and efficacy of metronomic oral     vinorelbine taken three times a week plus daily lapatinib without break, as salvage treatment     in patients with metastatic breast cancer.   "
222706|NCT00754715|"     The primary purpose of this study is to assess the safety and tolerability of AZD2516     following administration of a single dose.   "
222707|NCT00754728|"     Prospective, multi-center, non-randomized registry. 100 patients will be enrolled at up to 10     clinical sites in Europe. The results of this study will be compared to the TAXUS™ ATLAS     clinical trial to evaluate the safety of the product.   "
222708|NCT00754741|"     The purpose of this study is to compare the effectiveness of two different interventions to     improve adherence to diabetes medications among patients with diabetes and poor metabolic     control.   "
222709|NCT00754754|"     The purpose of this study is to utilize a sensor incorporated into a brain retractor blade to     monitor electrical activity and pressure applied to the brain during retraction required for     the selected skull base operations. The overall goal of the study is to develop a protocol     and guidelines to prevent the development of brain retraction injury during neurosurgical     procedures requiring significant retraction.   "
222710|NCT00754767|"     RATIONALE: L-carnitine L-tartrate may prevent peripheral neuropathy caused by chemotherapy.      PURPOSE: This randomized clinical trial is studying how well L-carnitine L-tartrate works in     preventing peripheral neuropathy caused by chemotherapy in women with metastatic breast     cancer.   "
222848|NCT00769652|"     This is a two-part study. Part I is an observational study. Part II is a randomized clinical     trial to see how well medical nutrition therapy works compared with standard care in treating     patients with lung cancer, pancreatic cancer, or stage III or stage IV prostate cancer.   "
222711|NCT00754780|"     The study is a phase II, open label trial of oral Pirfenidone in 24 adult patients with     neurofibromatosis type 1.      Pirfenidone is a new, broad-spectrum anti-fibrotic drug, with proven in vitro and in vivo     negative effects on fibroblast growth and collagen matrix synthesis. Human studies indicate     promising therapeutic effects in arresting and reversing fibrosis in a variety of different     conditions, where the excessive formation of fibrous tissue is a major pathogenic mechanism.     Since the fibrous tissue is a significant component of neurofibroma, reduction of fibrosis     could diminish tumor progression and lead to tumor shrinkage. Therefore, Pirfenidone is an     excellent candidate for the treatment of plexiform neurofibromas and surgically unresectable     tumors in patients with NF1.   "
222712|NCT00754793|"     The study hypothesis is that the addition of an antidepressant to the standard treatment     regimen in patients with both chronic sinusitis and depression or facial pain disorders and     depression will decrease the report of chronic sinusitis or facial pain symptom severity.      This is a stratified, randomized, double-blind, placebo-controlled study using the drug     escitalopram for the treatment of depression in patients experiencing depression and chronic     sinusitis or depression and facial pain disorders.      It is a 12-week study. Subjects will have a screening visit and then be followed up by phone     weekly for four weeks and bi-weekly for 8 weeks.   "
222713|NCT00754806|"     ABSTRACT      Background: Although there are some comparative studies between laparoscopy and hand-assisted     laparoscopic splenectomy (HALS) in splenomegaly cases, there is no study of the differences     between HALS and open splenectomy (OS). Our aim was to compare the HALS and OS techniques in     splenomegaly cases.      Methods: This prospective study included 27 patients undergoing splenectomy for splenic     disorders at the Department of General Surgery, Istanbul Medical Faculty between February     2007 and October 2007. OS was performed on 14 patients, and HALS was performed in the other     13 patients.      Key words: HALS, open splenectomy, splenomegaly   "
222714|NCT00754819|"     The purpose of this study is to evaluate the effect of colchicine on high sensitivity     C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute     coronary syndromes.   "
222715|NCT00754832|"     This research project will determine the safety and tolerability of ginseng in subjects with     MS and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment     of MS fatigue.   "
222716|NCT00754845|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is     not yet known whether letrozole is more effective than a placebo in treating in women with     breast cancer who have already received 5 years of aromatase inhibitor therapy.      PURPOSE: This randomized phase III trial is studying letrozole to see how well it works     compared with a placebo in treating women with primary breast cancer who have received 5     years of aromatase inhibitor therapy.   "
222717|NCT00754858|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving belotecan together with cisplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well belotecan works when given together with     cisplatin in treating patients with previously untreated extensive stage small cell lung     cancer.   "
222718|NCT00754871|"     This study will be investigated what mechanism of action Dienogest has. The growth of the     follicles, the endometrium, the hormones in the blood and the mucus that is produced by the     cervix that will be looked upon. Four different dosages of Dienogest (0.5 mg, 1 mg, 2 mg and     3 mg) will be investigated in healthy young women over two cycles, or up to a maximum of 72     days.   "
222719|NCT00754884|"     The purpose of this study is to determine whether nasal administration of salmon calcitonin     is effective and safe in the treatment of symptoms and signs of primary fibromyalgia.   "
222720|NCT00754897|"     We have been asked to participate in the Pediatric Anesthesia NeuroDevelopmental Assessment     Study (PANDAS), which is a study to compare neurocognitive functions in sibling pairs: one of     whom had exposure to anesthesia during inguinal hernia surgery before three years of age     (exposed) and the other who was not exposed to anesthesia or surgery in the first three years     of life (unexposed). A consortium of approximately 6 hospitals is doing this feasibility     study to determine if there is an adequate number of subjects for each of the two age groups     before the formal study begins.   "
222721|NCT00754910|"     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a     certain kind of light. When the drug is active, cancer cells are killed. This may be     effective against non-small cell lung cancer.      PURPOSE: This clinical trial is studying how well photodynamic therapy using porfimer sodium     works in treating patients with non-small cell lung cancer and bronchial disease.   "
222722|NCT00754923|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sorafenib works in treating non-smokers or     former light smokers with relapsed or refractory stage IIIB or stage IV non-small cell lung     cancer.   "
222723|NCT00754936|"     The purpose of this study is to examine the relationship between brain electrical activity in     elderly depressed patients and response to antidepressant medication treatment. Elderly     patients with depression will be treated for 12 weeks with an antidepressant medication     commonly used in clinical practice called escitalopram (Lexapro). Brain electrical activity     will be assessed using electrophysiological tests. Researchers are interested in whether the     brain electrical activity of elderly people with depression before they start the medication     can tell us who amongst them will improve with antidepressant treatment and to what extent.     They will also determine whether patients' brain electrical activity during the 12 weeks of     medication treatment will change in any way and whether this change will be linked with a     change in the severity of their depression. Researchers hope that information gained from     this study will help to better understand the brain processes associated with depression and     its successful treatment.   "
222724|NCT00754949|"     The purpose of this study is to determine if AzaSite Plus is effective and safe for the     treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.   "
222725|NCT00754962|"     The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets     under fasted conditions   "
222726|NCT00760305|"     The main aim of this study is to evaluate whether a patient education programme on cancer     pain management compared to standard care decreases pain and increases patients quality of     life. The investigators hypothesis is that patients and family caregivers who receive the     intervention will have improved outcomes. Patients and family members are seen in their homes     by the nurses doing the intervention over 6 weeks. Patients keep a diary of their pain and     medication intake.   "
222727|NCT00760318|"     The purpose of this study is to evaluate if there is an improved response in CD symptoms when     Keppra is used as adjunctive therapy to Botox.   "
222728|NCT00760331|"     Anomalies of renal development are well know for patients treated for MODY-5 diabetes due to     TCF2 mutation.A recent study confirms the existence of pediatric patients having TCF2     mutation but presenting renal anomalies alone.Endocrine and renal evolution of these patients     is unknown.The aim of this study is to follow a cohort of patients with TCF2 mutation and     initially presenting renal anomalies alone.   "
222729|NCT00760344|"     The purpose of this study is to determine the efficacy and safety of SYR-472, once daily     (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with     diet and exercise, or by taking metformin.   "
222730|NCT00760357|"     Once the patients are identified that have a full thickness wound on a limb clearly     identified as having critical limb ischemia, these patients will be evaluated. The data that     will be extracted from each chart will include patient's age, patient's gender, number of     office visits, presence of diabetes, presence of osteomyelitis, type and amount of antibiotic     administered, number of hyperbaric oxygen treatments, and if the wound healed.   "
222731|NCT00760370|"     The investigators major aim is to determine whether there is a difference in the retention of     zoledronic acid in multiple myeloma patients, compared to patients with breast cancer     metastasis to bone. In addition the investigators wish to analyze if the retention of     zoledronic acid is correlated to the extent of bone resorption/formation, and if there is a     tendency to changes in retention with sequential treatment.   "
222769|NCT00760877|"     The primary goal of this study was to determine the rate of confirmed best cumulative     complete molecular response (CMR) within the first year of study therapy with imatinib or     nilotinib. The study also explored the impact and significance of the achieved CMR on patient     outcomes (progression free survival (PFS), event free survival (EFS) and overall survival     (OS), characterized the kinetics of CMR achieved in both treatment arms and after the     cross-over.   "
222887|NCT00770367|"     SPECIFIC AIMS        1. To determine whether pioglitazone will reduce levels of asymmetric          dimethylarginine(ADMA) in patients with diabetes.        2. To determine whether nitric oxide(NOx) products are increased with pioglitazone          treatment.        3. To determine whether pioglitazone reduces oxidative stress (F2-isoprostanes).   "
222732|NCT00760383|"     The general hypothesis is that in older adults muscle regrowth after an acute musculoskeletal     stress will be positively influenced by traditional physical rehabilitation, and further     enhanced by nutritional supplementation. Using state-of-the-art stable isotope methodologies     for the study of muscle metabolism and methodologies for the measurement of cell signaling,     we will test the following specific hypotheses: 1) Total knee arthroplasty (TKA) induces an     acute net protein catabolism mainly by reducing muscle protein synthesis; 2) TKA induced     catabolism is attenuated by the ingestion of essential amino acids (EAA); 3) EAA     supplementation in combination with physical therapy (PT) will stimulate muscle protein     synthesis and mTOR signaling to a greater extent than PT with Placebo; and 4) EAA     supplementation during TKA PT rehabilitation will improve muscle strength, muscle volume and     functional outcomes to a greater extent than PT with Placebo.      Public Benefit: This research will focus rehabilitation efforts on specific and currently     unresolved mechanisms responsible for muscle loss following total knee replacement in older     adults. While knee pain due to bone arthritis is often alleviated after knee replacement,     complete return of physical function and independence is difficult to achieve. This research     will help to restore physical function and independence in the rapidly growing population of     older adults with knee arthritis.   "
222733|NCT00760396|"     The purpose of this study is to evaluate the safety profile, tolerability and     pharmacokinetics following multiple oral doses of 40mg to 200mg VGX 1027 in healthy subjects     administered for 5 days.   "
222734|NCT00760409|"     The purpose of this study is to determine if certain MRI imaging sequences (pictures) are     more helpful to the physicians in determining if a brain tumor has recurred or if the person     has radiation injury following their treatment.   "
222735|NCT00760422|"     The study is conducted in order to evaluate the performance of the NIT thrmometer by     comparing the predictive measurement to equilibrium measurement and to make a final tuning to     the thermometer algorithm.   "
222736|NCT00760435|"     The purpose of this study is to determine whether the addition of infliximab to standard     primary therapy of intravenous immunoglobulin (IVIG) and high dose aspirin will reduce     resistance to therapy in acute Kawasaki disease (KD).   "
222737|NCT00760448|"     This trial is conducted in UK. The aim of this clinical trial is to investigate lowering the     blood sugar and symptoms experienced during hypoglycaemia   "
222738|NCT00760461|"     The primary objective of this study is to prescribe oral domperidone for patients with     gastroparesis who have failed or suffered adverse effects from standard medical therapy.   "
222739|NCT00760474|"     The purpose of this study is to explore how pregabalin works in patients with fibromyalgia by     evaluating brain imaging signals. To find out whether fMRI (functional magnetic resonance     imaging) is an efficient way to show whether new pain medications are effective in treating     fibromyalgia.   "
222740|NCT00760487|"     The purpose of this study is to evaluate the effect that placement and power of the AcrySof     Toric has on post-operative visual acuity and spectacle independence for distance vision.     This will be determined by comparing manifest refraction pre-operatively and post-operatively     and by evaluating the rotational stability of the lens over time.   "
222741|NCT00760500|"     The surveillance of influenza virus among children with febrile reparatory complaints     attending the pediatric clinic in Shantou is an epidemiologic study to identify the type     (influenza A or B) and the subtype of Influenza A of the isolates from children with febrile     respiratory complaints who attend the pediatric clinic of the first Affiliated Hospital,     Shantou University Medical College, Shantou Guangdong, China. Also this study investigates     the genetic composition of all segments of isolated strains using standard molecular     techniques and to make available the new strains of influenza viruses isolated from such     children for the formulation of influenza vaccines. Clinical manifestation of the respiratory     illness is recorded and single nasopharyngeal swab is obtained from eligible children. Viral     culture is performed on the nasopharyngeal secretions. If influenza is isolated, this is     characterized if it belongs to influenza A or B. If the virus is characterized as influenza     A, further antigenic studies is done to determine subtype of influenza. Viral isolates is     further studied to determine the genetic composition of the virus. Information obtained from     the viral isolates is shared with the WHO and the CDC.   "
222742|NCT00760513|"     Non alcoholic fatty liver disease (NAFLD) imposes a high and increasing burden on the NHS,     yet there is presently no licensed treatment or validated approach to management. NAFLD     predisposes to increased risk of type 2 diabetes, increased risk of cardiovascular disease     and may progress to chronic irreversible liver disease.      In NAFLD patients, the investigators will test the hypothesis that treatment with long chain     n-3 fatty acid supplementation for 18 months favourably influences bio-markers for NAFLD and     risk factors for cardiovascular disease and type 2 diabetes.   "
222743|NCT00760526|"     The purpose of this study is to determine the efficacy, tolerability, safety, and effect on     quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.   "
222744|NCT00760539|"     The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness     of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma     or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997)     and Japan (C-08-08, NCT00760539).   "
222770|NCT00760890|"     Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested     the hypothesis that regular provision of a source of iron beginning at 4 months of age     improves iron status and could prevent iron deficiency. This was a prospective randomized     trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed     (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to     one of two interventions or to control. The interventions consisted in the daily     administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily     feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal     Group). The control group received complementary foods chosen by he parents but no source of     iron provided by the investigators. The interventions took place from 4 to 9 months. All     infants were subsequently followed to 2 years of age.   "
223071|NCT00764868|"     The primary objective of this study is to evaluate the long-term safety of LDX administered     as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years     of age inclusive at the time of consent).   "
222745|NCT00760552|"     The long-range goal of this research is to advance understanding of long-term blood pressure     (BP) control in patients with uncontrolled hypertension (HTN). The work builds on our     experience in implementing new models of care in Veterans Affairs (VA) and non-VA settings,     including three National Institute of Health (NIH) studies of pharmacist-based HTN     management. The long-term effectiveness of such models, especially in veterans, is unknown.     Thus, the primary goal of this study is to evaluate how to sustain long-term BP control in     veterans with HTN following a 6-month intensive pharmacist intervention.      This study will enroll veterans with uncontrolled HTN into a 6-month intensive     pharmacist-based intervention. Following this initial intervention, participants will be     randomized to continued intervention or a one-time patient and provider education     intervention. BP will be compared in the two groups over a 2-year follow-up period. The     intervention to control and sustain BP will follow VA guidelines and include: 1)     comprehensive medication assessment by the pharmacist; 2) an explicit plan to intensify     treatment if indicated; 3) strategies to improve adherence; and 4) follow-up pharmacist     visits to sustain BP control. The intervention is based on models identified in a recent     Agency for Healthcare Research and Quality (AHRQ) report as being the most potent strategies     to improve BP. The study will benefit from a strong research team with expertise in guideline     development, implementation science, quality measurement, and behavioral science. The study     will also provide important information on the degree to which BP control deteriorates after     patients are referred back to usual care. The specific aims and related hypotheses of the     study are to:      Aim 1:Compare BP control in patients randomized to long-term continuation of the pharmacist     intervention or to a less intense one-time patient and provider education intervention.      Hypothesis 1a: Patients randomized to the continued pharmacist intervention will have higher     rates of BP control 24 months after randomization.      Hypothesis 1b: Patients randomized to the continued pharmacist intervention will have lower     mean BP 24 months after randomization.      Aim 2: Compare antihypertensive medication intensification in patients randomized to the     continued pharmacist intervention or the less intense intervention.      Hypothesis 2: A higher proportion of patients who continued the pharmacist intervention will     have medication intensification over the 24-month follow-up.      Aim 3: Compare medication adherence in the two intervention groups. Hypothesis 3a: Medication     adherence will be higher in patients randomized to the continued pharmacist intervention     group during the 24 month follow-up period.      Hypothesis 3b: Improvements in medication adherence will be associated with improvements in     BP during each study interval.   "
222746|NCT00760565|"     This single center, multiple ascending dose study will assess the safety, tolerability,     pharmacokinetics and pharmacodynamics of RO4905417 at different doses in healthy volunteers     and patients with peripheral arterial disease. Three groups of 10 healthy volunteers will     receive RO4905417 (either 3mg/kg, 7mg/kg or 20mg/kg) or placebo iv every 28 days for a total     of 3 infusions. In addition, two groups of 6 PAD patients will receive RO4905417 (either     3mg/kg, 7mg/kg) or placebo and 1 group of 20 PAD patients will receive 20mg/kg RO4905417 or     placebo iv every 28 days for a total of three infusions. The study will have an adaptive     design with ongoing assessment of safety and tolerability prior to initiation of the next     dose. All subjects will receive 3 doses of RO4905417 or matching placebo at 28 day intervals.     The anticipated time on study treatment is 3-12 months, and the target sample size is <100     individuals.   "
222747|NCT00760578|"     The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type     2 diabetes.   "
222748|NCT00760591|"     Oral phosphate purgative is the preferred bowel regimen on the basis of better tolerability,     cost effectiveness, and efficacy. There are also numerous reports of patients with even     previously normal renal function developing acute and chronic kidney disease after use of     oral phosphate purgative. Several uncontrolled case reports and case series suggest a     potential link between oral phosphate and acute kidney injury and/or chronic kidney disease1.     Its use is contraindicated in patients with preexisting renal disease because of the risk for     developing acute renal failure, so called acute phosphate nephropathy, or electrolyte     disturbance. Since most of the outpatients who are going to undergo a colonoscopy are exposed     to this agent, it is important to detect or prevent vulnerable patients. We would seek a     sensitive and rapid diagnosis method of acute kidney injury following sodium phosphate bowel     preparation. Within a few hours, NGAL mRNA is highly upregulated after kidney injury, such as     renal ischemia-reperfusion and cisplatin nephropathy, NGAL induction precedes the elevation     of classical markers for kidney damage such as serum creatinine. The investigators will     investigate the change of NGAL following sodium phosphate bowel preparation.   "
222749|NCT00760604|"     The purpose of this study is to test 2 different methods of surgery to remove cancer in the     esophagus. This research is being done to see whether removing more tissue and lymph nodes     surrounding the tumor in the esophagus (known as transthoracic en bloc esophagectomy) offers     better control of the cancer than removing less tissue and lymph nodes (known as non-en bloc     esophagectomy).   "
222750|NCT00760617|"     The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline     Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older.      This protocol posting deals with objectives & outcome measures of the extension phase at year     1. The objectives & outcome measures of the primary phase are presented in a separate     protocol posting (NCT number = 00540592).   "
222751|NCT00760630|"     Newly developed diagnostic parameters have potential to differentiate between epicardial     disease and microvascular dysfunction with the help of anatomical details and physiological     endpoints and can be used in present clinical settings.   "
222767|NCT00760851|"     The purpose of this study is to determine the effectiveness of probiotics (popularly referred     to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent     absences from school/daycare centers of children two to four years old that attend daycare at     least 3 days per week. Two yogurt drinks will be administered, one containing a specific     strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will     experience fewer illnesses and absences from daycare.      In this study, participants will be asked to:        1. Give their child 4 oz. of the test yogurt each day for 90 days        2. Keep a daily diary of their child's health        3. Collect 3 stool samples from their child at the start, middle, and end of the study        4. Speak with research personnel on a bi-weekly basis regarding their child's health        5. Ensure that their child to consume any yogurts or probiotic-containing products for 110          days of the study   "
222849|NCT00769665|"     To evaluate safety with the use of Systane Ultra in contact lens wearers. A comparison to a     currently marketed contact lens rewetting drop will be included as a control.   "
222783|NCT00761059|"     Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of     preterm infants under CPAP therapy several times a day. Since the use of analgetic and     sedative drugs is accompanied with multiple side effects these are usually being avoided.     Glucose 20% has been shown to have an analgesic effect when administered to preterm infants     previous to some painful procedures (i.e blood sampling).      In this clinical trial the efficacy of orally administered Glucose 20% for relieving the     procedural pain of nasopharyngeal suctioning is tested. The investigators' study has a     cross-over design and is to include 40 patients.   "
222883|NCT00770315|"     This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH     39641/MK-3641/Amb a 1-U) compared with placebo in participants with ragweed-induced     rhinoconjunctivitis over a one-year period. It is expected that ragweed allergic participants     on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis     symptoms and require less allergy rescue medications during ragweed pollen season.   "
222752|NCT00760656|"     Childhood cancer predisposes to health risks that may not become apparent until many years     after completion of therapy. The SJLIFE protocol is designed to establish a lifetime cohort     of childhood cancer survivors treated at St. Jude Children's Research Hospital to facilitate     evaluation of health outcomes in aging adults surviving pediatric cancer.      The study focuses on the following Primary and secondary objectives:        -  To establish a lifetime cohort of childhood cancer survivors treated at St. Jude          Children's Research Hospital to facilitate evaluation of health outcomes in aging          children and adults surviving pediatric cancer.        -  To estimate the prevalence, cumulative incidence, and latency of selected late treatment          complications following predisposing therapeutic exposures in children and adults          surviving pediatric cancer.        -  To identify treatment, genetic, demographic, and psychosocial / behavioral related          predictors of adverse health outcomes.        -  To develop risk profiles for adverse health outcomes across the age spectrum to guide          development of clinical screening guidelines and risk-reducing interventions.        -  To identify factors that may be protective against the development of specific late          treatment complications.        -  To generate data for a series of future hypothesis-driven trials        -  To serve as a source for the collection of samples from child and adult volunteers for          future SJLIFE research.        -  To collect health outcomes data on a community control population for comparison          purposes.   "
222753|NCT00760669|"     The purpose of this observational study is to evaluate the safety and effectiveness of     infliximab injection under actual conditions of use in participants, and to learn more about     its adverse events.   "
222754|NCT00760682|"     There is currently not sufficient evidence that hyperbaric oxygen (HBO) benefits the surgical     removal of necrotic bone in osteoradionecrosis patients. This study aims at testing the     hypothesis that HBO does improve healing after surgical removal of necrotic bone in     irradiated previous head and neck cancer patients compared to not receiving HBO.   "
222755|NCT00760695|"     A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist.      Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol     compared to placebo      Secondary end points: Motor and inner restlessness and hormonal changes during the treatment.   "
222756|NCT00760708|"     Persantine is a drug that is routinely used to determine blood flow to the heart in the     diagnosis of coronary heart disease. Persantine causes an increase in the adenosine level in     the blood. Adenosine is a naturally occurring substance in the body that can increase blood     flow. Adenosine is normally removed from the bloodstream by an adenosine transporter, which     is a protein that takes up adenosine from the blood into cells. The increase in adenosine     levels in the blood is variable, and the cause for this variability is unknown. A mutation     for this transporter gene may contribute to this variability, and may alter its function.     Thus, the purpose of this study is to determine the relationship between the mutation and the     transporter function.   "
222757|NCT00760721|"     The purpose of this study is to design an intervention to increase hepatitis B (HBV)     screening among Korean Americans.      The investigators will design a culturally specific intervention (educational sessions) and     test the effect of the intervention on 1200 Korean Americans.      All subjects will be interviewed before the intervention/control sessions and 6 months after     the sessions to assess HBV screening levels in the two groups. Self-reported HBV screening     will be verified by a review of subjects' medical records.      The primary study hypothesis is that the intervention group will have a higher rate of HBV     serologic testing at follow-up compared to the control group.   "
222758|NCT00760734|"     This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric     oxygen therapy can improve cognition and brain imaging in subjects with either chronic     mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or     chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.   "
222759|NCT00760747|"     Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not     tolerating or not responding well to stimulant therapy will be included in this study. Two     different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10     weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be     compared between the two different switching approaches.   "
222760|NCT00760760|"     Inflammation in the adipose (fat) tissue is an important condition leading to metabolic     derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids     exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity.     This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose     tissue inflammation in morbidly obese patients.   "
222761|NCT00760773|"     The objective of this study is to determine for previously healthy children, who present to     an ED with acute gastroenteritis, if the probability of daycare absenteeism is significantly     different in those who receive a probiotic agent compared to those who receive placebo.   "
222762|NCT00760786|"     The purpose of this study is to determine whether intensive lipid lowering and Omega-3 fatty     acid are effective in the treatment of coronary atherosclerotic plaque.   "
222763|NCT00760799|"     The purpose of this study is to evaluate the benefits of anulus fibrosus repair utilizing     Xclose™ compared to a discectomy without anulus fibrosus repair.   "
222764|NCT00760812|"     This study will compare the effectiveness of two parent-based programs for helping young     children at risk of autism.   "
222765|NCT00760825|"     The purpose of this study is to determine whether the killed bivalent (O1 and O139)whole cell     oral cholera vaccine(Shanchol™) is safe and effective in the treatment of Vibrio cholerae.   "
222766|NCT00760838|"     The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of     azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain     inadequately controlled despite GINA (2006) step 4 or 5 therapy.   "
222768|NCT00760864|"     The purpose of this study is to evaluate the safety and efficacy of TAK-715, twice daily     (BID), in the treatment of rheumatoid arthritis signs and symptoms in patients with a partial     response to methotrexate.   "
222850|NCT00769678|"     This study examines whether a permanent stimulation of the diaphragm improves left     ventricular function in patients with severe heart failure following heart surgery.   "
222771|NCT00760903|"     The purpose of this study is to use magnetic resonance spectroscopy (MRS) and diffusion     tensor imaging (DTI) to assess for traumatic brain injury and determine if there is any     correlation of these findings to clinical outcome. MR spectroscopy using 2D-CSI (a multi     voxel technique) of the corpus callosum, basal ganglia, lobar white matter and brainstem may     reveal areas of injury and quantification of the metabolites from these areas may be used to     correlate with imaging findings and clinical evaluation. White matter disruption in these     areas is commonly seen after TBI, caused by diffuse axonal injury. It has been implicated in     the long term outcomes in these patients, but has been difficult to assess by standard     radiologic studies.      By the use of DTI it may be possible to demonstrate damaged white matter tracts which could     be helpful in the evaluation of traumatic brain injury. Most TBI subjects have injuries that     involved torque to the brain. This results in a shearing injury to the long white matter     tracts, which has been hypothesized to be related to cognitive outcome.      Also, to demonstrate that MRS and DTI prove valuable in predicting outcome in patients of     moderate brain trauma by conducting progressive studies acutely (within 24 hours) and long     term (4-6 weeks). Most patients will most likely be followed clinically for over a year, and,     if clinical indicated, farther scanning can be done at a later date.      By comparing fraction anisotropy, ADC values, and metabolic ratios by the use of DTI and MRS     in the adult and pediatric populations, may help to assess differences in recovery.      Lastly, a comparison between the two groups in changes in brain metabolism and/or white     matter tract disruption/re-connection after TBI with and/or without links to outcome can be     done.   "
222772|NCT00760916|"     This study is an international, multi-center, randomized, double-blind, placebo-controlled     study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e.,     endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy     treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of     efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical     history, physical exams, disease evaluation, and exercise tests. At the end of the first     12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open     label portion with visits occuring at 4-week intervals.      Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month     open-label, extension phase study (FREEDOM - EXT).   "
222773|NCT00760929|"     This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who     failed at least one standard chemotherapy regimen will determine the proportion of patients     with progression-free survival at 12 weeks following combination therapy with R1507 and     Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to     receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks.     Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related     endpoints including overall survival, objective response rate, time to response, time to     progressive disease and duration of response will also be evaluated. The anticipated time on     study treatment is 1-2 years, and the target sample size is <500 individuals.   "
222774|NCT00760942|"     This study aims to compare the short-term effects on growth and feeding tolerance of a liquid     high calorie formula added to human milk versus powdered human milk fortifier in small     preterm infants.   "
222775|NCT00760955|"     The purpose of this study is to determine the safety and effectiveness of TAK-583, once daily     (QD), in the treatment of neuropathy caused by diabetes mellitus.   "
222776|NCT00760968|"     The purpose of this study is to determine the efficacy and safety of TAK-783, once daily     (QD), taken in combination with methotrexate in subjects with rheumatoid arthritis.   "
222777|NCT00760981|"     To determine if subjects with steroid refractory cGVHD can tolerate imatinib mesylate and     whether their cGVHD responds to imatinib mesylate.   "
222778|NCT00760994|"     The purpose of this study is to determine whether an experiential acceptance therapy     intervention is effective in the treatment of alcohol dependency and post-traumatic stress     disorder (PTSD) symptoms in individuals who suffer from PTSD.   "
222779|NCT00761007|"     The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant     (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.   "
222780|NCT00761020|"     The main purpose of this trial is to study whether a certain blood test can reliably identify     the presence of malaria in people who have been infected with, but who do not have symptoms     of malaria.   "
222794|NCT00761202|"     This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when     administered for one month to patients with mild to moderate dry eye symptoms, with and     without contact lenses.   "
222795|NCT00761215|"     The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III     studies in patients with complicated skin and skin structure infections.   "
222796|NCT00761228|"     The purpose of this study is to test the drug apomorphine in subjects who are in a Vegetative     State or a Minimally Conscious State.   "
222781|NCT00761033|"     Many medical procedures aimed at helping children can cause them pain and distress. If     children experience certain levels of pain or distress, it can have long lasting negative     effects. The emergency department can be a particularly stressful place for children and     their parents. There are also many procedures that children may have in the emergency     department that can cause pain and distress. These include procedures such as needle pokes,     stitches, or setting a broken bone. Two common methods of managing a child's pain in the     emergency department are drugs and distraction. Drugs are not always practical and may come     with unwanted side effects. Distraction is often used formally or informally and by parents     or the health professionals. One form of distraction involves listening to music. This can     lower the child's pain and distress by moving their attention from the painful stimulus, for     example a needle poke, to a more pleasant sensation such as familiar children's songs. This     study will test whether music is useful to help lower pain and distress for young children     (ages 3 to 6 years) who are visiting an emergency department and need an intravenous line.     Music is safe and pleasant for children. The results from this study could be important for     many children receiving medical care.   "
222782|NCT00761046|"     Retrospective data collection of the CENOS implant comparing with and without BoneMaster HA     coatings.   "
222784|NCT00761072|"     Total intravenous anesthesia(TIVA) is a commonly used anesthetic technique. Although TIVA can     be accomplished with a variety of drug combinations, infusions of Propofol and Remifentanil     are often used with dosage adjusted manually by the anesthesia provider.The pharmacokinetics     of these drugs are well understood, and that knowledge has led to the development of computer     controlled infusion pumps that can administer the drugs based upon pharmacokinetic models.     Computer controlled infusion schemes automatically adjust the drug administration based upon     pharmacokinetic models which typically dictate a tapering infusion scheme. When one considers     the dosage of a computer controlled infusion it is obvious that manually imitating a similar     scheme may be difficult.This study will evaluate manually controlled infusion schemes using     the models built into the Applied Medical Visualizations (Medvis) display and compare the     manual dosage schemes to the predicted effect site concentrations and pharmacodynamic effect.   "
222785|NCT00761085|"     To determine the pharmacokinetics of methadone in children and adults with SCD who are     experiencing a painful episode.   "
222786|NCT00761098|"     Spontaneous bacterial peritonitis (SBP) is a common and frequently fatal complication of     end-stage liver disease with a mortality of up to 10%, primarily due to the development of     kidney failure. Current standard practice is to treat this infection with broad spectrum     antibiotics and salt-poor albumin administration on day one and three of treatment. In this     study the investigators test the hypothesis that the administration of a second dose of     albumin at 48 hours only to patients with renal insufficiency, is as effective at preventing     kidney failure as administering the second dose to all patients at 72 hours.   "
222787|NCT00761111|"     The purpose of this study is to translate and assess an evidence based educational booklet on     low back pain patients beliefs after lumbar discectomy.   "
222788|NCT00761124|"     The purpose of this intervention trial is aiming to increase inform decision- making in     Latino men regarding prostate cancer screening.      The investigators propose to find out how much Latino men know about the benefits and risks     of prostate cancer screening and what factors influence how they decide whether or not to     have screening. The investigators are also interested in learning how providing education     information, both verbally and in print, about the risks and benefits of prostate cancer     screening affects men's interest and knowledge.      The intervention is an interactive multi-media presentation made up of a small group of 8-10     Latino men gathered to discuss about prostate cancer, screening methods, treatment, and the     controversy within the medical community regarding PSA screening. A facilitator guides the     1-hour discussion and encourages participant interaction. The effect of this intervention was     tested on 1000 Latino men within Los Angeles county.      Participants were recruited from 38 community venues (churches, community center, etc.). All     participants were interviewed before being randomized to receive written (control group) or     oral (intervention) prostate cancer education material. All of the participants will be     followed up at 6-months via a telephone interview.      The investigators hypothesize that the intervention group will have an increase knowledge of     prostate cancer, will have increase communication with family, friends, and medical provider,     and will have an increase rate of PSA screening compared to the control group.   "
222789|NCT00761137|"     The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral     dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in     Parkinson's disease (PD) patients.   "
222790|NCT00761150|"     The primary purpose of the study was to test the efficacy of 2 tablets (twice daily) of     ABT-712, compared to placebo, administered over a 4-week period in participants with moderate     to severe mechanical chronic low back pain (CLBP).   "
222791|NCT00761163|"     The purpose of this study is to identify the body's response to aerobic vs. resistance     exercise. Throughout this study, we will examine food intake, appetite, and physical and     mental well-being before, during, and after aerobic and resistance exercise.   "
222792|NCT00761176|"     The objective of this study is to compare the reduction in wound surface areas between     patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy     (PRFE) as an adjunct to standardized basic wound care to those utilizing standardized basic     wound care alone.   "
222793|NCT00761189|"     The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER)     in participants with schizophrenia (psychiatric disorder with symptoms of emotional     instability, detachment from reality, often with delusions and hallucinations, and withdrawal     into the self).   "
222797|NCT00761241|"     This study is being conducted to find out what effects (good and bad) that a combination of     treatment with chemotherapy, radiation therapy and surgery has on you and your pancreatic     cancer. The chemotherapy drugs to be used: Gemcitabine, Docetaxel, Oxaliplatin, 5-FU and     alpha-interferon. The goal is to decrease the size of the tumor, so that removal by surgery     can be performed. Current treatments for this stage of pancreas cancer offer less than ideal     results, with little opportunity for treatment with curative intent.   "
222798|NCT00761254|"     The purpose of this study is to make Domperidone available to patients with gastrointestinal     disorders who have failed standard therapy and who might benefit from it.   "
222799|NCT00761267|"     Prospective, open label study to assess the pharmacokinetics, safety & efficacy of     anidulafungin when used to treat children (aged 1 month - <18 years) with invasive     candidiasis, including candidemia (ICC).   "
222800|NCT00761280|"     In this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared     to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed     recurrent or refractory anaplastic astrocytoma (WHO grade III) or secondary glioblastoma (WHO     grade IV).   "
222801|NCT00761306|"     The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine     over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed     6-week acute treatment in study NCT00839423 / 11492A.   "
222802|NCT00761319|"     The purpose of the study is to compare two ophthalmic solutions in patients with open-angle     glaucoma or ocular hypertension.   "
222803|NCT00761332|"     The purpose of this study is to compare the effectiveness of teriparatide versus therapies     that decrease bone loss to prevent new or worsening back pain in patients with osteoporosis     seen in clinical practice.   "
241390|NCT01010945|"     This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib)     and nab-paclitaxel in patients with advanced pancreatic cancer.   "
222804|NCT00761345|"     People with pancreatic cancer usually have a large amount of the cancer in the area of the     pancreas and around it when they are diagnosed with it. Or their cancer has spread     (metastasized)outside that area of the abdomen and is not able to be surgically removed     (resected). For patients with metastatic disease, one standard treatment is the combination     of gemcitabine and erlotinib. This combination has shown slightly longer survival compared to     getting gemcitabine alone. For patients with localized but unresectable disease, the standard     treatment remains controversial. Early studies showed that chemotherapy and radiation     together was better than either one used alone. The greatest benefit of external beam     radiotherapy may be after a period of full-dose chemotherapy alone, to help the rapid spread.     A problem of beginning treatment with standard radiotherapy is that the doses of chemotherapy     usually have to be reduced sometimes by half.      Studies have already shown that low dose radiotherapy (LDRT)is safe. This study will evaluate     the safety of LDRT instead of standard doses with full dosing of gemcitabine and erlotinib in     patients with locally advanced or limited metastatic pancreatic cancer. Patients will be     enrolled in groups of 3 to 6 each with a slightly higher dose of LDRT and erlotinib.      For patients with locally advanced disease, this protocol also may help because most patients     develop and die from spread to the liver and abdominal cavity.   "
222805|NCT00761358|"     The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects     with Functional Dyspepsia, focusing on the assessment of subjective symptoms.   "
222806|NCT00761371|"     Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients   "
222807|NCT00761384|"     90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the     liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.   "
222808|NCT00761397|"     The goal of this research study is to help patients complete the swallowing and dental care     exercises they are supposed to perform during radiation treatment.   "
222809|NCT00761410|"     The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional     stability with a post-operative passive range of motion of greater than 125° of flexion and     to demonstrate that the range of motion does not compromise the longevity of the implant.   "
222810|NCT00761423|"     The study will be a double-blind randomized single-center clinical trial comparing 3     treatment groups with chronic midportion Achilles tendinopathy.   "
222811|NCT00761436|"     Tolerability and Efficacy of Spheramine will be evaluated after operative implantation     (Stereotactic Intrastriatal Implantation) in patients with advanced Parkinson's Disease   "
222812|NCT00761449|"     The aim of this study is to investigate the efficacy of lenalidomide in high risk MDS or AML     with chromosome 5 aberrations.   "
222813|NCT00761462|"     Objective and subjective musculoskeletal evaluations will be performed to determine     differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we     can tell what the natural occurrence of such musculoskeletal conditions is in the general     pediatric population.   "
222814|NCT00761475|"     Incisional hernia is the most frequently seen long term complication in surgery causing much     morbidity and even mortality in patients. Despite studies on the optimal closing technique     for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %.     Major risk factors for incisional hernia after a laparotomy, like obesity, steroid use,     malnutrition, smoking and connective tissue disorders, are known. Despite this knowledge,     there has not yet been developed a sufficient method for prevention. One specific group of     high risk patients are patients with an abdominal aortic aneurysm (AAA). The relationship     between aortic aneurysm and other abdominal wall hernias, like inguinal hernias, has been     reported. Retrospective and prospective studies have shown an average risk for incisional     hernia after AAA repair of 31.6 %. Another high risk group is the group of obese patients.     Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after     midline incision with an incidence of 22% after 12 months. Considering only 50 % of     incisional hernia will be clinically evident in the first 12 months, the total incidence will     be above 30%. This high risk group of patients with obesitas and aneurysmatic disease can     benefit most from prevention. Some small studies have been performed to evaluate the     usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh.     These studies show a very low risk for incisional hernias and a low infection rate, even when     used in contaminated wounds such as colostomal surgery. However, there has not been performed     an adequate randomized controlled trial to study the prevention of incisional hernias. Our     hypothesis is that incisional hernia prevention with use of prosthetic mesh after laparotomy     is effective in patients with aortic aneurysm and in obese patients with a BMI of more than     27.   "
222815|NCT00761488|"     To allow surgeons to obtain clinical experience on the postoperative uncorrected and best     distance corrected visual acuities (UCVA and BDCVA) and corneal and refractive cylinder of     the AcrySof Toric IOL.   "
222816|NCT00761501|"     The purpose of the study is to investigate the uptake in the body of naproxen; one of the two     active substances in PN400. We also want to show that the body's uptake of naproxen given as     PN400 is comparable to that of currently marketed naproxen tablets.   "
222818|NCT00761527|"     The purpose of this study is to observe the side effects of desloratadine syrup and how     effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children. The     participants will take desloratadine syrup for 14 days. At the end of treatment, side effects     will be recorded, as well as how the participants tolerate the medication. Effectiveness will     also be rated at the end of treatment.   "
222819|NCT00761540|"     This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood     concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin     (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin)     of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be     observed.   "
222820|NCT00761553|"     The purpose of this study is to determine the effects of food supplements and strength     training on appetite, the amount of energy used, and body composition.   "
222821|NCT00761566|"     In this study, we will test the hypothesis that preconditioning highly trained swimmers using     skeletal muscle ischemia as the stimulus will improve exercise performance assessment.   "
222822|NCT00761579|"     The purpose of this study is to investigate the safety and efficacy of flexibly dosed     paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder     with symptoms of emotional instability, detachment from reality, often with delusions and     hallucinations, and withdrawal into the self).   "
222823|NCT00761592|"     This pilot study estimates the treatment effects of two different types of botulinum toxin     type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive     contraction of the muscles around the eye and can lead to repetitive blinking or sustained     closure of the eyelids.   "
222824|NCT00761605|"     The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone     extended-release (mechanism to dissolve a drug over time in order to be released slower and     steadier into the blood stream) in improving or maintaining the subjective symptoms of the     participants in three participants' groups (that is, by the reason to switch: lack of     efficacy group, lack of tolerability group, and lack of compliance group) who switched from     other previous antipsychotic drugs to paliperidone extended-release tablets at flexible     doses.   "
222825|NCT00761618|"     The goal of this clinical research study is to learn if draining the IPC every day is better     at than draining it 3 times a week.   "
222826|NCT00761631|"     This open-label, multicenter study is designed to evaluate the safety, tolerability and     immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than     15 months up to less than 18 years.   "
222827|NCT00761644|"     The goal of this clinical research study is to learn the highest safe doses of the     combination of Doxil (liposomal doxorubicin), Avastin (bevacizumab), and Torisel     (Temsirolimus) that can be given to patients with advanced cancer that has spread or is     unable to be surgically removed. The safety and effectiveness of this combination of drugs     will also be studied.   "
222828|NCT00761657|"     The primary objective of the study is to evaluate the safety, tolerability and     pharmacodynamic effects of 5 different oral doses of FG-4592 administered two times or three     times weekly for up to 4 weeks to subjects with Chronic Kidney Disease not requiring     dialysis.   "
222829|NCT00761670|"     Primary objectives        -  To compare neurocognitive effects of amisulpride with those of risperidone in patients          with chronic schizophrenia, as assessed by the general cognitive index, a measure of          overall cognitive functioning in schizophrenia      Secondary objectives        -  Secondary analyses will be conducted to determine how the two atypical agents'          neurocognitive effects compare with regard to their profile of therapeutic action (based          on individual cognitive domain scores in seven cognitive domains, including speed of          processing, attention/vigilance, working memory, verbal learning and memory, visual          learning and memory, reasoning and problem solving and social cognition);        -  Investigate whether amisulpride elicits more improvement on negative symptoms compared          to risperidone treatment, as measured by the total score on the Scale of the Assessment          of Negative Symptoms (SANS) 8 and by the Negative Symptom Subscale of the Positive and          Negative Symptom Scale (PANSS);        -  Assess whether amisulpride improves overall functioning and individual domains of          psychotic symptoms compared to risperidone as measured by the Clinical Global Impression          (CGI), and the total and positive and general psychopathology subscale scores of PANSS          and by the individual domains of SANS, respectively;        -  Evaluate the safety and tolerability of amisulpride and risperidone based on the study          completion rates, and frequency of abnormal laboratory values, prolactin serum          concentrations and on the Simpson Angus Scale for Extrapyramidal Symptoms (SAS) 10 and          the Abnormal Involuntary Movement Scale (AIMS).   "
222830|NCT00761683|"     To observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent     reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the     effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction     scores for pelvic tenderness and indurations; to observe the reduction in the proportion of     patients requiring analgesics for the relief of pelvic pain for 6 months in patients treated     with Zoladex 3.6 mg.   "
222831|NCT00761696|"     The primary objectives of the study are:        -  To determine the safety and the maximum tolerated dose (MTD) of IPI-926        -  To examine the pharmacokinetic parameters of IPI-926 and its characterized major          metabolite(s)        -  To recommend a dose and schedule of IPI-926 for subsequent studies   "
222832|NCT00761709|"     The purpose of this study is to evaluate the safety and intraocular pressure (IOP)-lowering     efficacy of AL-39256 in patients with open-angle glaucoma or ocular hypertension.   "
222833|NCT00769431|"     RATIONALE: Collecting feedback from patients with prostate cancer may help doctors develop     better symptom management educational materials for patients.      PURPOSE: This clinical trial is evaluating symptom management educational materials for     patients with prostate cancer.   "
222847|NCT00769626|"     The purpose of this study is to compare the clinical outcomes and costs associated with two     different management strategies for patients with acute low back pain who consult their     primary care physician. The investigators hypothesize that management using a brief,     standardized physical therapy intervention will result in better outcomes than management     based on current practice guideline recommendations of watchful waiting for the first 4 weeks     following consultation.   "
222834|NCT00769457|"     Patients suffering from heart failure and a markedly reduced pumping capacity and sometimes     desynchronization of the lower chambers of the heart have a higher risk of suffering sudden     cardiac death.      These patients can be treated with an Implantable Cardiac Defibrillator that terminates     dangerously fast heartbeats and in case of asynchronous pumping of the heart can also     re-synchronize the lower chambers of the heart (ICD- or CRT-D-system). Patients that moreover     suffered from a worsening of their cardiac status (cardiac decompensation) and had to be     hospitalized for this reason have a higher risc to have following decompensations. New     technology, incorporated into modern Medtronic ICD- and CRT-D-Systems, that measures the     amount of water in the lungs is able to warn before such a dangerous worsening occurs. If     coupled with modern data transmitting technology (CareLink), automatic information in case of     a worsening of the cardiac status can be sent to caregivers, who in turn can react timely in     order to prevent a worsening an subsequent hospitalization.      The study examines to which extent this new technology prevents potentially adverse cardiac     situations and / or hospitalizations and has an influence of the duration of patient´s lives.   "
222852|NCT00769704|"     The objective of this study is to evaluate the efficacy and safety of treatment with     talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with     unresectable Stage IIIb, IIIc and Stage IV melanoma. The efficacy endpoints of the study aim     to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as     compared to GM-CSF.   "
223092|NCT00765141|"     The intent of this protocol is to salvage human-related material that is normally destined     for destruction, so it can be used in infection-related scientific studies.   "
222835|NCT00769470|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known     whether docetaxel and carboplatin are more effective when given together with trastuzumab     and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer.      PURPOSE: This randomized phase II trial is studying how well docetaxel and carboplatin work     when given together with trastuzumab and/or lapatinib in treating women with stage I, stage     II, or stage III breast cancer that can be removed by surgery.   "
222836|NCT00769483|"     Objectives:      Primary Objectives:        -  Phase I: Determine the maximal tolerated dose (MTD) of MK-0646 in combination with          gemcitabine or gemcitabine plus erlotinib and recommended phase II dose.        -  Phase II:             -  Assess progression-free survival (PFS) with a) gemcitabine plus MK-0646 b)               gemcitabine plus erlotinib plus MK-0646 and c) gemcitabine plus erlotinib.             -  Explore IGF1 tissue level as a predictive biomarker for MK-0646 therapy in phase II               expansion cohort.      Secondary Objectives:        -  Assess overall response rate (ORR), treatment toxicity, and overall survival (OS) with          the addition of MK-0646 to gemcitabine or gemcitabine plus erlotinib.        -  Correlate PFS and OS with IGF-1, IGFBP-3 levels and the expression of p-IRS, IGF-1R, EMT          biomarkers, Akt, Erk, mTOR, and PI13k in tumor cells.        -  To assess the incidence of single nucleotide polymorphisms of the IgF1R pathway related          genes (IGF1, IGF1R, IRS1 and IRS2). These genotypes will be correlated with the clinical          endpoints of this study, including OS, ORR and PFS.   "
222837|NCT00769496|"     A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients     undergoing hemodialysis   "
222838|NCT00769509|"     The goal of this study is verify if the energy expenditure in preterm infant fed with human     milk is different from preterm formula. A randomized, controlled, crossover, double blind     clinical trial will be carried out in which the newborn will be its own control.     Randomization will be according to the type of diet at the beginning of the study. Half of     the participants will be randomly assigned to begin the study using one type of milk (for     example, human milk) and later another type of milk (preterm infant formula) and the other     half will do the opposite.   "
222839|NCT00769522|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and     bendamustine, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can     block cancer growth in different ways. Some block the ability of cancer cells to grow and     spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. It is not yet known whether giving fludarabine and cyclophosphamide together with     rituximab is more effective than giving bendamustine together with rituximab in treating     chronic lymphocytic leukemia.      PURPOSE: This randomized phase III trial is studying fludarabine, cyclophosphamide, and     rituximab to see how well they work compared with bendamustine and rituximab in treating     patients with previously untreated B-cell chronic lymphocytic leukemia.   "
222840|NCT00769535|"     Polymorphisms of HSP70 and tumor necrosis factor-alpha promoter in patients with     hepatocellular carcinoma, chronic liver disease and healthy controls will be measured by     PCR-RFLP or direct sequencing. The clinical relevance of patients will be compared in those     with polymorphism and those without.   "
222841|NCT00769548|"     RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Hormone therapy     combined with radiation therapy may be a more effective treatment for prostate cancer.      PURPOSE: Randomized phase III trial to compare the effectiveness of four different     combinations of radiation and hormone therapy in treating patients with prostate cancer.   "
222842|NCT00769561|"     The purpose of this study is to develop and evaluate a biofeedback-based cognitive behavioral     treatment for patients with chronic temporomandibular disorders using a randomized controlled     design.   "
222843|NCT00769574|"     To assess diagnostic and prognostic value of new biomarkers in patients admitted for     suspicion of non ST elevation acute coronary syndrome (NSTE ACS).   "
222844|NCT00769587|"     RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to     the disease.      PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with     relapsed or progressive systemic mastocytosis.   "
222845|NCT00769600|"     Primary Objectives      To evaluate the 3-month event-free survival of the combination of the combination of     itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer.      Secondary Objectives      To determine the objective response rate of the combination of itraconazole and pemetrexed in     patients with recurrent/refractory non-small cell lung cancer.   "
222846|NCT00769613|"     RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are     infected with cytomegalovirus.      PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients     who have undergone donor stem cell transplant and have cytomegalovirus infections.   "
222851|NCT00769691|"     Blood flow to the brain is normally regulated to ensure a constant supply of blood with     oxygen and nutrients. During heart surgery using cardiopulmonary bypass, blood pressure is     kept at a level that may or may not be below an individual's lower level of brain blood flow     autoregulation. If lower, the brain may be exposed to an inadequate blood flow that could     result in brain damage. The purpose of this study is to examine whether monitoring with a     non-invasive FDA approved device that measures oxygen saturation of the superficial layers of     the brain (near infrared spectroscopy) can, when combined with blood pressure measurements,     provide information on the blood pressure level where brain blood flow is not autoregulated.     The goal of this research is to develop a method to individualize blood pressure during     surgery to a level that is within a patient's brain blood flow autoregulation range as a     means for improving outcomes for patient undergoing heart surgery.   "
223134|NCT00765687|"     A multicenter Prospective Study to assess the screening methods, parameter of NTX and the     efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in     patients of non-small cell cancer with bone metastasis in china.   "
222853|NCT00769717|"     For over four decades the medical literature has observed a relationship between obesity and     poorer health outcomes. The causal mechanisms of these poorer outcomes however are unclear.     One assumption that has been supported by correlational data is that increased weight is     associated with increased cardiovascular disease (CVD) risk factors (i.e., hypertension,     dyslipidemia, and type 2 diabetes). Consequently, obese people are routinely prescribed     weight loss programs in order to prevent or control these conditions. Unfortunately, long     term weight loss has been met with minimal success for the large majority of people.     Furthermore, the data suggesting that weight loss leads to long term health benefits and     decreased mortality is limited and contradictory. The purpose of the proposed project is to     perform a randomized controlled pilot study comparing the effectiveness of two lifestyle     interventions for preventing CVD risk factors (hypertension, dyslipidemia, and type 2     diabetes). The interventions are constitutionally similar; however, the treatment condition     is a wellness-focused intervention that teaches healthy living without consideration of     weight. The control condition is a traditional curriculum where the prescribed outcome is     weight loss. The primary goals of both programs are to reduce hypertension and total     cholesterol, and to enhance glucose control. Secondary outcomes of interest are psychological     and behavioral in nature (e.g., self-esteem; depressed mood; anxiety; stress; quality of     life; dietary habits; and physical activity). We will compare the trajectories of the CVD and     psychological/behavioral risk factors for a total period of 24 months (including the time     from baseline to the end of the 6-month intervention). Our objectives are to collect data to     a) determine whether participants in both programs reduce CVD and psychological/behavioral     risk factors at the completion of the 6-month program, and b) compare the persistency of     health improvements and rate of relapse at the end of the 18-month follow-up period between     the traditional weight loss intervention and the wellness-focused intervention.   "
222854|NCT00769730|"     Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative     management of patients with hepatocellular carcinoma (HCC). Few previous studies had     demonstrated that the serum level of anticancer drug from patients treated by TACE was     similar to those treated by systemic chemotherapy. Since systemic chemotherapy may have the     possibility to influence patient's general defense ability, hepatitis B virus may reactivate     after chemotherapy.This study is to investigate the possibility of TACE in the reactivation     of hepatitis B virus.   "
222855|NCT00769756|"     Context: Endeavours to reduce overweight by calorie-restriction diets are often neither     sufficient nor sustained. The growing obesity epidemic demands additional measures to enhance     and sustain weight loss.      Objective: To evaluate three alternative weight-loss measures on top of a calorie-restriction     diet.      Design, Setting, and Participants: Six-month randomized and controlled trial using a     three-factorial design. The participants were 110 families with 142 obese parents and their     119 obese children.   "
222856|NCT00769769|"     This study will compare the effectiveness of face-to-face cognitive behavioral therapy versus     telephone-based cognitive behavioral therapy for treating African Americans who care for     family members with dementia.   "
222857|NCT00769782|"     RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal     stromal tumor.      PURPOSE: This phase II trial is studying how well surgery works in treating patients with     liver metastasis from a gastrointestinal stromal tumor.   "
222858|NCT00769795|"     The purpose of this study is to determine whether combination treatment of prostate cancer     with IMC-A12 (an antibody which blocks insulin-like growth factor receptor activity) with     hormonal therapy (testosterone lowering) before prostatectomy, will be more effective than     prior results with hormonal therapy alone.   "
222859|NCT00770003|"     The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848     administered intranasally to seasonal allergic rhinitis patients.   "
222860|NCT00770016|"     The aim of this study is to further characterize the treatment related changes in insulin     sensitivity, substrate metabolism and intra hepatic- and intramyocellular lipid content in     patients with hypothyroidism   "
222861|NCT00770029|"     The study objective was to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over     placebo by evaluation of treatment success analyzing the investigator's rating on the Facial     Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients     with moderate to severe glabellar frown lines to be randomized in a 2:1 ratio to receive one     injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day 120.   "
222862|NCT00770042|"     This study is being conducted to examine the effect of three CYP3A4 inhibitors (ketoconazole,     erythromycin and ritonavir) on the single dose pharmacokinetics of avanafil. Ketoconazole and     ritonavir are potent inhibitors of CYP3A4 and erythromycin is a moderate CYP3A4 inhibitor.     Any interaction that is observed would be predictive of other inhibitors of CYP3A4.   "
222863|NCT00770055|"     RATIONALE: Gathering information about patients with breast cancer over time may help doctors     learn more about a patient's use of the internet to find information about treatment, symptom     management, and emotional support.      PURPOSE: This clinical trial is studying internet use among women with recurrent metastatic     breast cancer.   "
222864|NCT00770068|"     This study will examine whether spring and fall seasonal depression in individuals with high     sensitivity to pollen is linked to seasonal increases in tree and ragweed pollen.   "
222865|NCT00770081|"     This clinical trial is designed to provide additional information on the safety and     tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in     patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular     filtration rate (GFR) < 30 mL/min) for a period of 52 weeks.   "
222866|NCT00770094|"     Comparison of LASIK outcomes using 3 different lasers and a total of 5 different treatment     platforms.   "
222868|NCT00770120|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with     pleural malignant mesothelioma that cannot be removed by surgery.   "
222869|NCT00770133|"     The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline     ophthalmic solution compared to vehicle and its individual components in alleviating the     signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.   "
222870|NCT00770146|"     The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen     for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of     statin and who have a diagnosis that puts them at least at high risk of coronary heart     disease (CHD).   "
222871|NCT00770159|"     This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822     in healthy postmenopausal women.   "
223135|NCT00765700|"     Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting     of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment     of acute musculoskeletal pain.   "
222872|NCT00770172|"     RATIONALE: Colony-stimulating factors, such as G-CSF, may increase the number of white blood     cells found in bone marrow or peripheral blood and may prevent persistent neutropenia in     patients receiving chemotherapy. It is not yet known which regimen of G-CSF may be more     effective in preventing neutropenia.      PURPOSE: This randomized phase III trial is comparing two different regimens of G-CSF to see     how well it works in preventing persistent neutropenia in patients with solid tumors who are     receiving chemotherapy.   "
222873|NCT00770185|"     RATIONALE: Ridaforolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying the side effects of ridaforolimus and to see how     well it works in treating patients with recurrent metastatic and/or locally advanced     endometrial cancer.   "
222874|NCT00770198|"     Chronic liver disease are characterized by increased levels of plasma IL-6, but the     bioactivity of this cytokine in this disease is not well known. IL-6 receptor complex is     regulated by multiple receptors subunits: the soluble form of IL-6 Receptor enhance IL-6     signal by a process called trans-signaling on cells expressing few membrane IL-6 receptors.     Soluble gp130 is the natural inhibitor of IL-6 trans-signaling. The aim of this study is to     characterize circulating and liver levels of theses compounds of IL-6 receptor complex, to     unravel the bioactivity of IL-6 in this disease.   "
222875|NCT00770211|"     The study objective is to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over     placebo by evaluation of treatment success analyzing the investigator's rating on the Facial     Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients     with moderate to severe glabellar frown lines will be randomized in a 2:1 ratio to receive     one injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day     120.   "
222876|NCT00770224|"     RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find     cancer cells and carry cancer-killing substances to them without harming normal cells.     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as     cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Giving a radiolabeled monoclonal antibody together with rituximab and combination     chemotherapy may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects of giving iodine I 131 tositumomab     together with rituximab and combination chemotherapy and to see how well it works in treating     patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin     lymphoma.   "
222877|NCT00770237|"     In this study, we will compare cue-reactivity in smokers with and without schizophrenia and     the influence of smoking cues on responding for cigarette puffs under a PR schedule of     reinforcement. Given the high prevalence of smoking among individuals with schizophrenia,     understanding some of the environmental factors that serve to maintain nicotine dependence is     a critical step in improving smoking cessation treatment outcomes. Establishing and     validating a laboratory model of cue-elicited responsivity and cigarette self- administration     will allow the investigation of the efficacy of anti-craving medications in people with     schizophrenia.      Specific Aims 1) To compare the effects of smoking versus neutral cues on craving, mood, and     autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia. 2) To     compare the effects of smoking versus neutral cues on the reinforcing efficacy of tobacco     cigarettes in smokers with schizophrenia and smokers without schizophrenia.      Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood     (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and     temperature) responsivity. During self-administration trials, primary measures include     breakpoint (final ratio completed), total number of responses, and number of cigarette puffs     earned and taken. Secondary measures include baseline smoking history, mood form, TCQ-SF, CO,     FTND, and urinary cotinine and 3-hydroxycotinine (3-HC).      The ratio of 3-HC/cotinine is a phenotypic biomarker of the rate of nicotine metabolism,     which has been shown to be associated with level of nicotine dependence, various smoking     behaviors, and treatment outcome (Ho & Tyndale, 2007). We will correlate the primary measures     with the 3-HC/cotinine ratio to explore possible relationships for future study.   "
222878|NCT00770250|"     To evaluate the concordance of the most frequently used words by the patients and the     physicians to express asthma symptoms, according to the patient's level of asthma control.   "
222879|NCT00770263|"     Define the maximum tolerated dose and dose limiting side-effects of temsirolimus in     combination wtih erlotinib in patients with resistant solid tumors   "
222880|NCT00770276|"     MOPS: Mannheim Obesity Pilot Study      Introduction:      Obesity is a central feature of the metabolic syndrome. With increasing prevalence of     overweight and obesity, the incidence of WHO III° obesity will further augment. In this     subset of obese patients, metabolic complications and cardiovascular risk are major clinical     issues. Epidemiological data show that with increased BMI mortality rises (1). The SOS-Study     demonstrated, for the first time, that bariatric surgery and consecutive weight reduction are     associated with a decrease in cardiovascular and overall mortality. Significant mortality in     this study was caused by cardiovascular events and cancer.      Metabolic Syndrome - MS - Despite varying definitions of the metabolic syndrome, obesity is     one of its central features. Depending on the definition used, it can represent an obligate     criterion (IDF) or a facultative parameter (WHO and ATP III). Even though not obligate,     extreme obesity is a central risk factor for most other parameters of the metabolic syndrome.      Endothelial dysfunction -ED- represents the initial step of atherosclerosis (3). An     appropriate measurement is the evaluation by retinal analysis. Epidemiological data     demonstrate increased cardiovascular risk with retinal vessel pathology (4).   "
223335|NCT00774072|"     The purpose of this study is to determine whether the nasal inhalation of Gernebcin® is     effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.   "
222881|NCT00770289|"     Tools known as 'depression scales 'are widely used as assessments to evaluate a patient's     response to treatment. The purpose of this study is the evaluation of the remission rates for     patients with MDD. The evaluation will involve the use of HAM-D 17, and HAM-D 7     questionnaires and the comparison of those questionnaires.   "
222882|NCT00770302|"     Saxagliptin is a new investigational medication being developed for treatment of type 2     diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and     its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses     of 5 mg saxagliptin in healthy Chinese subjects.   "
222884|NCT00770328|"     PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to     play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with     antibodies and the drug pentoxifylline have been shown to lower PAI-1 levels in animal     models. This study tests the hypothesis that pentoxifylline will lower PAI-1 levels in human     subjects.   "
222888|NCT00770380|"     A majority of smokers who quit return to smoking within three months of their quit date. This     study is a randomized trial to investigate the effectiveness of hypnosis versus behavioural     counseling to promote maintenance of abstinence or relapse prevention in quitting smokers.     The hypothesis is that hypnosis will be at least as effective as behavioral counseling in     preventing relapse to smoking in smokers who are able to quit for at least three days.   "
222889|NCT00770393|"     Patients were eligible if they had biopsy proven, previously untreated T3 with fixed cord     involvement squamous cell carcinoma of the pyriform sinus.      The study compare conventional radiotherapy with concurrent cisplatin to induction     chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary     end point was the preservation of the larynx. The secondary end points included toxicity,     causes of death and survival rates.   "
222890|NCT00770406|"     A pilot study to examine efficacy and safety of intravesical botulinum toxin type A.   "
222891|NCT00770419|"     RATIONALE: Gathering information over time about patients' sense of being a burden on their     caregiver, and caregivers' sense of burden on themselves, may help doctors learn more about     the desire to die in patients with late-stage cancer.      PURPOSE: This clinical trial is studying perceptions of burden in patients with late-stage     cancer and their caregivers.   "
222892|NCT00770432|"     Randomized, placebo-controlled, double blind study. 203 subjects entered the study to compare     the effect on occasional constipation of polyethylene glycol 3350 to placebo. Subjects took     one of study treatments up to 7 days.   "
222893|NCT00770445|"     The purpose of this study is to determine the Anti-Inflammation Effects of Pioglitazone,     twice daily (BID), and Pioglitazone/Metformin Combination Therapy BID in Type 2 Diabetes     Subjects Treated with Insulin.   "
222894|NCT00770458|"     Validate that circulating cell free fetal nucleic acid can be used to identify a direct     marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than     surrogate markers.   "
222895|NCT00770471|"     RATIONALE: ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving ABT-888 together with     radiation therapy and temozolomide may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-888 when     given together with radiation therapy and temozolomide and to see how well it works in     treating patients with newly diagnosed glioblastoma multiforme.   "
222896|NCT00770484|"     The main limitation patients with orthostatic intolerance (OI, or postural tachycardia     syndrome, POTS) have to exercise is related to their increase in heart rate when standing.     Main pharmacological treatment today is aimed at reducing heart rate with the use of     betablockers (propanolol), this theoretically could also improve their exercise capacity; if     their heart rate do not increase as much with the medication, they could exercise more. In     addition, it has been suggested that in healthy volunteers subjected to head down tilt for 2     weeks (situation that produces a simulated transient POTS-like state) a single bout of     intense exercise can improve orthostatic tolerance the day after exercising. The mechanisms     involved in such response are not that clear but could be an increase in plasma volume     already diminished in POTS patients. It seems likely that the same could be true for POTS     patients.      The purpose of the present study are to pharmacologically improve the amount of exercise POTS     patients can perform by reducing their baseline heart rate (specific aim 1) and to evaluate     next day heart responses to an acute bout of intense exercise.      Therefore, the specific aims of this study are:        1. To test the hypothesis that lowering heart rate response with propanolol will result in          an increase in exercise capacity.        2. To test the hypothesis that a single bout of exercise will result in an improvement in          orthostatic tolerance the day after exercising.   "
222897|NCT00770497|"     The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on     low grade inflammation and vascular function in hypertensive patients.   "
222900|NCT00770536|"     This study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386     in combination with either pegylated liposomal doxorubicin or topotecan in subjects with     recurrent ovarian cancer. Up to 100 subjects will be enrolled to receive AMG 386 in     combination with either pegylated liposomal doxorubicin every 4 weeks (cohort A) or topotecan     weekly on days 1, 8, and 15 of a 28 day dosing schedule (cohort B). Subject enrollment and     assignment to either cohort will be based on eligibility and the investigator's discretion.      It is hypothesized that AMG 386, in combination with each of the chemotherapy regimens:     either pegylated liposomal doxorubicin or topotecan will be safe and well tolerated in     subjects with recurrent ovarian cancer.   "
222901|NCT00770562|"     This study will compare the efficacy, safety, and pharmacokinetics of standard treatment     versus standard treatment plus MabThera in patients with ITP. The anticipated time on study     treatment is <3 months, and the target sample size is 100-500 individuals.   "
222902|NCT00770575|"     The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and     atorvastatin combination therapy compared to atorvastatin monotherapy in patients at risk for     cardiovascular disease.   "
222903|NCT00770588|"     This is a double blind, multicentre, randomized, placebo-controlled study. The eligible     patients will be randomized to receive gefitinib or placebo at 1:1 ratio. This study will     recruit 296 male or female, histologically or cytologically diagnosed locally advanced or     metastatic NSCLC patients with a World Health Organization (WHO) Performance Status (PS) 0-2.     Patients must have completed 4 cycles of platinum based first line doublet chemotherapy     without experiencing disease progression or unacceptable toxicity. The chemotherapy shall be     given every 3 weeks, which includes cisplatin or carboplatin, combined with any one of the     following: gemcitabine, paclitaxel, docetaxel, vinorelbine.   "
222938|NCT00771043|"     Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to     evaluate the neuroprotective effects of Natalizumab (TYSABRIÂ®) or Interferon beta-1a     (AVONEXÂ®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL     thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple     Sclerosis (RRMS).   "
241680|NCT01022411|"     The specific aim of this study is to determine the effects of substituting brown for white     rice on the treatment of metabolic syndrome (MetS).   "
222904|NCT00770601|"     This study will examine whether a medicine called canakinumab is safe and effective for     treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as     chronic infantile neurologic, cutaneous, articular (CINCA) syndrome. This disease can cause     rash, joint deformities, brain inflammation, problems with the eyes and learning     difficulties. Canakinumab is an experimental drug that inhibits the action of a protein     produced by the body called interleukin 1, which is responsible for the symptoms in NOMID and     also contributes to many other kinds of inflammatory diseases.      Patients 2 years of age and older with NOMID may be eligible for this study. Participants     undergo the following procedures:      Screening Phase        -  Medical history and review of medical records        -  Blood tests        -  Daily diary of symptoms and medicines take      Washout/Lead-in Phase        -  Discontinuation of anakinra or other medications      Treatment Phase        -  Injection of canakinumab under the skin every 8 weeks for 6 months        -  Monitoring and evaluations during treatment, including:        -  Quality-of-life questionnaires and daily diary        -  Vital signs measurements (heartbeat, blood pressure, temperature)        -  Blood tests        -  Electrocardiogram        -  Tuberculosis skin test        -  Neurological, eye and skin examinations at beginning and end of study        -  Cognitive evaluation at beginning and end of study        -  Lumbar puncture (spinal tap) at the beginning of the study, 2 weeks after the second          dosing of canakinumab and at the end of the study        -  X-rays and bone density scan at beginning and end of study        -  Magnetic resonance imaging (MRI) of the head at beginning and end of study      Follow-up Phase        -  Monthly clinic visits after the last dose of canakinumab for a minimum of 60 days      End-of-Study Evaluation        -  Series of tests 8 weeks after last dose of canakinumab to evaluate treatment response          and side effects   "
222905|NCT00770614|"     The purpose of this study is to determine whether hydration with sodium bicarbonate is more     effective than hydration with sodium chloride to prevent contrast induced nephropathy in     patients undergoing Primary Coronary Intervention for Acute ST Elevation Myocardial     Infarction.   "
222906|NCT00770627|"     Principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the ADHD     children's behaviour during 12 weeks on two years. The secondary focus is to evaluate the     effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities,     anxiety and depression.      The omega 3 fatty acids don't present adverse side effects. The inclusion to the trial could     avoid the intake the methylphenidate and its associated adverse side effects.   "
222907|NCT00770640|"     The purpose of this study is to determine the metabolic and cardiovascular effects of     pioglitazone, once daily (QD), and insulin combination therapy in subjects with Type 2     Diabetes and Renal Failure.   "
222908|NCT00770653|"     The purpose of this study is to compare pioglitazone and metformin combination therapy, twice     daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects     with dyslipidemia.   "
222909|NCT00770666|"     Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6     months in smokers with medical illness   "
222910|NCT00770679|"     Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and     help prevent heart disease. We are testing whether statins improve endothelial function more     in the arteries that have worse endothelium to begin with. One of the functions of the     endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in     different situations. This affects how blood flows through those vessels. Magnetic resonance     imaging (MRI) can be used to evaluate endothelial function in the arms and legs     noninvasively. You are being asked to participate in a study using MRI to test whether a     3-week course of statins improves the endothelium of legs more than it improves the     endothelium of arms.      Adults with type 2 diabetes may join.   "
222911|NCT00770692|"     The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in     non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with     insomnia.   "
222912|NCT00770705|"     Phenoxybenzamine, an irreversible alpha-adrenergic blocker, may prove beneficial to infants     and children with congenital heart disease undergoing open cardiac repair, due to a theoretic     benefits of a uniform and smooth reduction in systemic vascular resistance in the     perioperative period. Vasodilation allows for low pressure, high flow systemic perfusion     while on cardiopulmonary bypass. Support for the use of phenoxybenzamine in humans has been     documented in several studies involving the perioperative management of both adults and     children requiring cardiopulmonary bypass, and in management of patients with     pheochromocytoma. 1-7 Phenoxybenzamine has been associated with more uniform body cooling and     rewarming, and improved tissue perfusion during bypass.8 It is also known to increase cardiac     output, stroke volume, and renal blood flow when given intravenously. 9 Specifically in     pediatric open heart surgery, the combined use of phenoxybenzamine and dopamine provided a     stable hemodynamic condition without a high total peripheral vascular resistance and     stimulated postoperative diuresis. 9 Afterload reduction with parenteral phenoxybenzamine in     neonates undergoing the Norwood procedure for hypoplastic left heart syndrome is associated     with improved systemic oxygen delivery and stabilization of systemic vascular resistance.10     Furthermore, a strategy of reducing afterload with phenoxybenzamine and stabilizing the     pulmonary to systemic flow ratio in this select population of patients has also been shown to     improve operative survival. 11 We hypothesize that phenoxybenzamine will reduce afterload on     the systemic ventricle in our selected patient population, thereby improving ventricular     performance and decreasing the risks of pulmonary to systemic flow imbalance associated with     current short-acting vasodilator therapy. We will plan to evaluate both physiologic variables     as well as surgical outcomes in the selected study population.   "
223336|NCT00774085|"     The purpose of this study is to assess treatment and outcomes data in patients receiving     treatment with long-acting injectable risperidone.   "
222913|NCT00770718|"     The purpose of this dose-ranging pilot study is to compare Recombinant Activated Factor VII,     Prothrombin Complex Concentrate and Fresh Frozen Plasma (each starting at low doses with     escalation if necessary) for the reversal of warfarin in the setting of acute intracranial     hemorrhage.   "
222914|NCT00770731|"     The goal of this clinical research study is to find the highest tolerable dose of Torisel     (temsirolimus), Hycamtin (topotecan hydrochloride), and Velcade (bortezomib) that can be     given, in combination, to patients with advanced cancer that has spread or is unable to be     surgically removed. The safety of this drug combination will also be studied.   "
222915|NCT00770744|"     The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in     patients suffering from schizophrenia compared to a standard antipsychotic drug.   "
222916|NCT00770757|"     This study will test the safety and effectiveness CC-4047 (pomalidomide) in patients with     advanced, steroid refractory graft-versus-host disease.   "
222917|NCT00770770|"     This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with     macular edema secondary to RVO.   "
222918|NCT00770783|"     The investigators intend to test in a single center, clinical pilot efficacy study the     primary hypothesis that Magnetic Seizure Therapy (MST) as add-on therapy to a controlled     pharmacotherapy is efficacious in the treatment of refractory major depression assessed with     the Hamilton Depression Rating Scale (HAMD).   "
222919|NCT00770796|"     In this randomized study the investigators wish to explore the role of pre-procedural statin     therapy for the prevention of contrast induced nephropathy in patients with     moderate-to-severe renal dysfunction, submitted to elective coronary or angioplasty.   "
222920|NCT00770809|"     This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib     to see how well they work in treating patients with stage II or stage III breast cancer that     can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known     which regimen is more effective in treating patients with breast cancer.   "
222921|NCT00770822|"     This study will compare high intensity focused ultrasound to standard brachytherapy in the     treatment of primary, organ confined prostate cancer.   "
222922|NCT00770835|"     The purpose of this study is to determine the efficacy of pioglitazone compared to     glibenclamide, once daily (QD), taken together with metformin and lifestyle modification in     type 2 diabetic subjects with cardiovascular disease.   "
222923|NCT00770848|"     The primary objectives of this study are the following:      Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with     mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of     the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio     (HR) for overall survival (OS) of previously treated subjects with castrate-resistant     prostate cancer (CRPC)   "
222924|NCT00770861|"     This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic     patients with stage 1 or stage 2 hypertension   "
222925|NCT00770874|"     This study is an open-label, multicenter, multinational, two-arm, parallel randomized Phase 3     study evaluating the efficacy and safety of S-1+Cisplatin versus single-agent Cisplatin in     patients with stage IVB, recurrent or persistent carcinoma of the cervix.   "
222926|NCT00770887|"     The purpose of this study is to assess continuation rates and patient satisfaction with self     administration subcutaneous depot medroxyprogesterone acetate.   "
222927|NCT00770900|"     Verify if the quantitative parameters of the eosinophils activation and phagocyte system     function show a predictive value for clinical response and prognostic in patients with     persistent asthma treated with montelukast   "
222928|NCT00770913|"     The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients     with Proton Pump Inhibitor-resistant reflux esophagitis.   "
222929|NCT00770926|"     This study aims to design and test the effectiveness of a lifestyle diabetes risk reduction     program, Live Well, Be Well, in reducing risk of diabetes in persons at risk with a focus on     reaching lower-income, minority individuals.   "
222930|NCT00770939|"     Diabetic foot ulcers are a challenge to health care professionals because there are only few     effective topical therapeutic interventions.      Growth factor treatment has shown to be beneficial for healing of diabetic foot ulcers in     conjunction with extensive surgical debridement. Autologues platelet releasate which contains     platelet derived growth factor appears to be more effective than standard therapy in case     studies.      This protocol will evaluate the healing effect of Vivostat PRF treatment of non-eschemic foot     ulcers to identify responders and to enable sample size calculation for a subsequent pivotal     trial.   "
222931|NCT00770952|"     The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and     glimepiride combination therapy compared to glimepiride monotherapy in subjects with Type 2     Diabetes.   "
222932|NCT00770965|"     This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses     of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque     psoriasis will be randomized to receive either AIN457 at one of the three doses studied or     placebo.   "
222933|NCT00770978|"     The purpose of this research study is to measure the levels of ceftobiprole in the blood and     urine during and after administration of four doses of ceftobiprole. Safety of the drug will     also be evaluated.   "
222954|NCT00771251|"     The purpose of this study is to evaluate the safety and effectiveness of golimumab in     patients with active rheumatoid arthritis despite DMARD (Disease-modifying antirheumatic     drugs) therapy. Another objective is to evaluate the pharmacokinetics of golimumab.   "
222955|NCT00771264|"     The purpose of this study is to demonstrate superiority of percutaneous posterior tibial     nerve stimulation (PTNS) therapy compared to sham therapy for the treatment of patients with     overall bladder (OAB) symptoms.   "
222934|NCT00770991|"     This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized     black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will     undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for     the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the     initiation of study treatment. The size and number of rectal polyps will be documented on a     code sheet and by photograph. The efficacy outcome will include the percentage reduction in     the number of rectal polyps between baseline and 36 weeks.   "
222935|NCT00771004|"     The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on     heart functioning before, during and after stent implantation.   "
222936|NCT00771017|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation     therapy, such as bicalutamide, leuprolide, and goserelin, may lessen the amount of androgens     made by the body. Vaccine therapy may help the body build an effective immune response to     kill tumor cells. It is not yet known whether androgen ablation therapy is more effective     with or without vaccine therapy in treating patients with prostate cancer.      PURPOSE: This randomized phase II trial is studying androgen ablation therapy to see how well     it works when given together with or without vaccine therapy in treating patients with     prostate cancer.   "
222937|NCT00771030|"     This Phase 1b/2a study will evaluate safety, tolerability PK and PD of AMG 827 when     administered in multiple SC and IV doses in patients with active rheumatoid arthritis in     combination with a stable dose of DMARDs. Part A is dose escalation (to assess safety &     tolerability), and Part B is dose expansion (to assess clinical efficacy) at the highest     tolerated dose level of AMG 827 from Part A.   "
222939|NCT00771056|"     Eligible CLL patients who sign an informed consent will be started on hydroxychloroquine     400mg po daily for up to one year. They will be monitored for disease status as well as     adverse reactions after two weeks and then every 4 weeks. Ophthalmologic exams is required at     baseline and every 6 months or sooner if the patient develops any visual disturbances.   "
222940|NCT00771069|"     This study will address the treatment rate and control rate of hypertension, treatment     pattern and factors to affect blood pressure control by examining (retrospective) medical     records of Type II DM patients with DM related complication and hypertension, among     outpatients coming to the Endocrinology Department in 20 general hospital settings     nationwide.   "
222941|NCT00771082|"     The purpose of this study is to examine the relationship between body composition and knee     osteoarthritis, and effects of inflammatory, metabolic, and hormonal factors.   "
222942|NCT00771095|"     Participants in both the existing and enhanced podcast groups will lose weight. The enhanced     podcasting group will have a greater increase in weight loss, elaboration, self-efficacy, and     perceived control than the existing podcast group.   "
222943|NCT00771108|"     The purpose of this research is to provide a better understanding of how exercise (walking)     affects non-alcoholic fatty liver disease (NAFLD) in overweight people. NAFLD, which is     common in obese people, occurs when the liver has too much fat.   "
222944|NCT00771121|"     This study is a randomized, double-blind, placebo-controlled bilateral study on the effect of     moisturizing creams on skin barrier function. The hypothesis is that a new active emulsion     has a better influence on skin barrier function comapred to its placebo.   "
222945|NCT00771134|"     This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression     in patients with bipolar disorder.   "
222946|NCT00771147|"     Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and     calculation of related medical costs.   "
222947|NCT00771160|"     A clinical study evaluates the efficacy and safety of MK0476 in adult patients with Perennial     Allergic rhinitis.   "
222948|NCT00771173|"     The primary aim of this randomized clinical trial is to compare the utility of     phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the     post-operative period in the gynecologic patient using mean VAS measurments.   "
222949|NCT00771186|"     The goal of this study is to further study the role of LEMG in accurately predicting the     recovery of vocal function as well to study the timing of a change of LEMG activity prior to     such return of function. We aim to do this by collaborating with several active pediatric     otolaryngological practices throughout the country who in turn have agreed to evaluate     infants and children with vocal fold immobility who fit a standardized inclusion and     exclusion criteria by means of a standardized LEMG protocol over a one year period of time.     Our particular goal is to collect and then review information over a one year period of time     on all children evaluated for vocal fold immobility by means of LEMG.   "
222950|NCT00771199|"     The purpose of this study is to evaluate safety/tolerability and clinical utility of low-dose     transdermal therapeutic system (TTS [medicated adhesive pad that is placed on the skin to     deliver a timed-release dose of medication through the skin into the bloodstream]) - fentanyl     in Taiwan participants with cancer pain. Secondly, to demonstrate the dropout rate that will     be decreased by initiating therapy with12 microgram per hour (mcg/hr) instead of with 25     mcg/h.   "
222951|NCT00771212|"     The purpose of this study is to describe the use of pain treatments in Taiwan, the     demographics, clinical characteristics of patients requiring pain treatments, current     treatments, outcomes of treatments and the reasons for changing pain medication during     treatment.   "
222952|NCT00771225|"     180 women with genital prolapse will be submitted to genital prolapse surgical correction,     half of them with human fascia, and the other half with Prolift.   "
222953|NCT00771238|"     This pilot study will compare the incidence of pressure ulcers and the change in existing     pressure ulcers for patients who are either placed on the new TC500 bed against those placed     on the standard ICU bed in the Cardiovascular unit of University of Nebraska Medical Center.     Additionally, the cost associated with rental beds will be calculated as well as skin care     compliance. Sixty patients will be enrolled (30 per study arm).   "
222956|NCT00771277|"     Traumatic brain injury (TBI) has been called the signature injury of the Iraq War. This pilot     study investigated family needs of 6 rural families caring for a Veteran with TBI. Two     Veterans had moderate TBI and all had comorbid post traumatic stress disorder diagnoses. The     veterans were 1 to 5 years post-injury. Families were reluctant to include others in helping     the family because of privacy concerns, desire for independence, and negative employment     repercussions if the extent of the TBI deficit became known in the community. Most were still     employed, despite TBI deficits. Despite having previously received information, families     still had substantial needs for information about the condition and its prognosis and     sequelae (e.g., why things happen, unsafe/frightening behaviors, work, finances,     communication changes) and the availability and types of services (e.g., who to contact,     benefits, help needed)   "
222957|NCT00771290|"     Intra-operative colonoscopy (inserting a flexible endoscope with a camera at its tip through     the anus and up into the rectum and colon) is most often indicated to locate or verify the     location of small cancer, polyp, bleeding site, or simply to inspect the bowel after the two     ends have been rejoined together. Usually colonoscopy utilizes ambient air to expand and     inflate the colon and, as a result, leaves the colon bloated or distended until the gas is     either expelled or absorbed. This endoscopy related bowel distension is problematic in the     setting of both traditional open (big incision) colorectal surgery and after minimally     invasive (laparoscopic assisted) procedures.      In the case of the former, it may prove difficult to close a traditional laparotomy incision     if the bowel is distended and may hinder respiration with the abdomen closed. In the setting     of a laparoscopic procedure, the bowel distension limits the working space available to the     surgeon. Since the laparoscopic domain is limited, a distended colon following     intra-operative colonoscopy can prevent the minimally invasive completion of a case (meaning     that a conversion to traditional open methods would be necessary) that otherwise was going     well with good prospects of laparoscopic completion. Colonic distension also causes abdominal     pain and lengthens the recovery time from the procedure.      The investigators believe that the use of CO2 during intra-operative colonoscopy or     sigmoidoscopy (exam of only the last 2 to 2 ½ feet of the colon) will not cause long lasting     bloating or distension of the colon as opposed to air. Carbon dioxide is absorbed 250 times     faster than ambient air and may decrease after procedure colonic distension. This     prospective, randomized study will compare the two gases in terms of colonic distension.     Patients undergoing open or minimally invasive colorectal resection will be randomized to     undergo intra-operative colonoscopy using one of the two gases. Direct measurements of colon     diameter will be taken at specific time intervals after the colonoscopy.   "
241725|NCT01023022|"     The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in     clinical practice in the country specific healthcare setting.   "
222958|NCT00771303|"     Venous thromboembolism (VTE) remains a major cause of maternal morbidity and mortality in     developed countries. Objective diagnosis of pulmonary embolism (PE) and/or deep vein     thrombosis (DVT) in pregnancy is crucial. Failure to identify PE or/or DVT will place the     mother's life at risk, and unnecessary treatment will not only expose her to anticoagulants     but will also label her as having had VTE. Thus, this diagnosis has serious implications for     the management of her present pregnancy, and for other aspects of her life ranging from     contraception to thromboprophylaxis in future pregnancies and hormone replacement therapy in     later life. It is therefore critical that all women with symptoms or signs that suggest     venous thromboembolism have appropriate investigation and diagnosis based on objective     diagnostic tests.      The current diagnostic approach in suspected PE is based on sequential diagnostic tests: 1)     assessment of clinical probability, 2) fibrin D-dimer measurement, 3) compression     ultrasonography of lower limb veins and 4) multi-slice computed tomography (MSCT). However,     physicians are reluctant to perform MSCT in pregnant women because of potential adverse     effect of radiation exposure to the fetus. For this reason, ventilation/perfusion or     perfusion-only lung scan has been the cornerstone of PE diagnosis in pregnant women. Indeed,     perfusion lung scan was assumed to be associated with less radiation than computed tomography     (CT). However, this technique is now widely abandoned in the usual diagnostic strategy of PE     for the following reasons: it is not widely available; its interpretation may be difficult     and the test may be inconclusive in the presence of other chest abnormalities. Moreover,     recent data convincingly show that the radiation exposure associated with single-slice or     multi-slice CT exposes the fetus to less radiation than perfusion lung scan.      However, the use of CT has never been adequately validated in pregnant women with clinically     suspected PE. The investigators, therefore, plan to set up a prospective management study in     which pregnant women with suspected PE will undergo a sequential diagnostic strategy based on     1) assessment of clinical probability 2) D-dimer measurement 3) compression ultrasonography,     and 4) MSCT.      Nowadays, the overestimated fear of radiation exposure for the fetus leads to an irrational     attitude and inadequate investigations in pregnant women with suspected PE, even though both     European [3, 4] and North-American guidelines [5] suggest that only objective testing may     accurately rule out the disease. The proposed study should lead to an increased awareness of     the risks and benefits of appropriate imaging in pregnant women suspected of PE and should     result in a more rational management of this under-studied patient group.   "
222959|NCT00771316|"     The purpose of this study is to demonstrate that MK0826 is comparable to Meropenem in the     treatment of complicated Urinary Tract Infections (UTIs) in adults.   "
222960|NCT00771329|"     Phase I study designed to determine the safety and tolerability of a single dose of BIIB023     administered intravenously versus placebo to subjects with RA.   "
222961|NCT00771342|"     The purpose of this study is to determine the fungicidal efficacy of nitric oxide and it's     effect on the clinical signs and symptoms associated with Tinea Pedis   "
222962|NCT00771355|"     This is a pilot study to evaluate the findings of the Reflectance Confocal Microscopy when     performed in cutaneous pigmentary disorders, such as vitiligo, melasma, post-inflammatory     hyper-pigmentation and hypo-pigmentation. Confocal Microscopy is a recent diagnostic     technique that has been used for observation of skin conditions that affect the superficial     layers of the skin.   "
222963|NCT00771368|"     The purpose of this study is to determine if gaseous nitric oxide is effective in the     treatement of bacteria in MRSA positive ulcers   "
222964|NCT00771381|"     In about half the cases of breast cancer, there is hypoxic (no, or little oxygen) tissue     present. Hypoxic cells can be resistant to treatment and may cause increased tumour growth.     This study will use 18F-FAZA PET scans before surgery or treatment to assess whether patients     have hypoxic tumours. The results will be compared to tissue samples removed during surgery     and to the distribution of 18F-FDG.   "
222965|NCT00771394|"     To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive     bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH)     with tamsulosin hydrochloride for at least 6 weeks   "
222966|NCT00771407|"     The purpose of this study is to compare the clinical outcomes of patients undergoing surgery     for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay,     as measured by postoperative occurence of parastomal hernia.   "
222967|NCT00771420|"     Investigate safety and tolerability of the escalating dose of CAM-3001 in patients.   "
222968|NCT00771433|"     RATIONALE: G-CSF may prevent or reduce febrile neutropenia in women receiving chemotherapy     for breast cancer. It is not yet known which G-CSF regimen is more effective in preventing     neutropenia.      PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia in     women receiving chemotherapy for breast cancer.   "
222969|NCT00771446|"     Evaluate on how well the ELAD system works in treating people with liver failure.   "
222970|NCT00771459|"     The purpose of this study is to examine whether local infiltration analgesia (LIA) with     Ropivacaine and adrenaline is effective in the treatment of postoperative pain after major     spine surgery.   "
223337|NCT00774098|"     We would like to study the effect of preserving liver glycogen storage by using intravenous     dextrose infusion on postoperative liver function and complications after major liver     resections.   "
222971|NCT00771472|"     Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese     patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in     Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be     newly enrolled in Part II.   "
222972|NCT00771485|"     The purpose of this study is to evaluate the effectiveness of FM-602 as a bowel preparation     before colonoscopy.   "
222973|NCT00771498|"     This is a pharmacokinetic, descriptive, open-label, prospective, multicentric, national study     in Aids and tuberculosis co-infected patients, to be laboratory and clinically monitored     during the treatment with lopinavir-ritonavir and rifampin medications.      Study population: Thirty patients older than 18 years, both male and female, which present     active tuberculosis and failure or contraindication for any motive to an efavirenz will be     selected to participate in the study.      Objectives:        -  Evaluate the pharmacokinetics of lopinavir-800mg / ritonavir-200mg combination (every 12          h) in association with rifampin-containing anti-tuberculosis regimens, in patients          presenting tuberculosis and HIV-infected with indication to antiretroviral treatment          according to Brazilian Ministry of Health's guidelines, with contraindication to the use          of NNTRI.        -  Describe the adverse events observed during the tuberculosis treatment period with          rifampin associated with antiretroviral therapy consisting of lopinavir-800mg /          ritonavir-200mg every 12 hours.        -  Describe clinical, immunological and virological endpoints throughout the study with          these drugs.   "
222974|NCT00771511|"     In the setting of fetal demise it is important to help the mother deliver the fetus     expeditiously and with as little physical trauma as possible. We hypothesize that application     of capsaicin to the uterine cervix will enhance cervical ripening and desensitize pain fibers     such that delivery is less painful.   "
234162|NCT00912639|"     The purpose of this study is to evaluate the response rate in patients with taxane-pretreated     recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).   "
222975|NCT00771524|"     This study is being performed to measure the amount of the antibiotic ceftobiprole (study     drug) found in the bone and blood after receiving one dose prior to your elective hip     replacement surgery. A piece of your hip bone which will be removed as part of your surgery     will be analyzed to determine how much ceftobiprole gets into the bone.   "
222976|NCT00771537|"     The purpose of this study is to test the effects of different persuasive informational     messages on rates of rapid HIV testing and willingness to participate in a HIV vaccine     clinical trial. Adult African-American, non-Latina White, and Latina women will be recruited.     Women will initially be randomized to 4 groups: 1. no message control; 2. 1-sided message     that mentions benefits of HIV testing; 3. 2-sided message that acknowledges minor opposition     to testing, then refutes the opposition; and 4. 2-sided message that acknowledge stronger     opposition to testing, then refutes the opposition. Women will be offered HIV testing, then     re-randomized to a similar set of 4 messages related to HIV vaccine trials. There will     therefore be 16 groups in total (4 X 4).   "
222977|NCT00771563|"     Rationale: a number of recent phase III randomized trials have shown a survival benefit of a     treatment with subcutaneous low-molecular weight heparin in patients with advanced solid     malignancies. The survival advantages observed in the studies persist for months after the     active treatment with LMWHs. Therefore these survival advantages are thought to be due to     effects of LMWHs on tumor cell biology.      First line treatment of advanced NSCLC patients with the Cisplatin + Docetaxel combination     has been widely studied, and is amongst the most active treatments currently available. The     occurrence of grade 3/4 thrombopenia in several phase III trials was in the 0-3% range,     making it an ideal chemotherapy regimen to combine with LMWHs in the treatment of advanced     NSCLC.   "
222978|NCT00771576|"     The investigators hypothesize that PET scans will be able to differentiate between normal,     reduced or increased BCM in human subjects. Subjects with normal BCM will be recruited from     among normal weight nondiabetic people with plasma insulin levels within the normal range.     Subjects with predicted reduced BCM will be recruited from among patients with T1DM who have     with low or not measurable insulin levels. If results from the nondiabetic subjects and the     subjects with T1DM are found to differ significantly, subjects with increased BCM will be     recruited from among patients with hyperinsulinemia including those with obesity and the     metabolic syndrome. PET scan measurements of the pancreas will be obtained and compared in     people predicted, on the basis of biochemical testing, to have normal or reduced, or     increased BCM.   "
222979|NCT00771589|"     The purpose of this study is to develop a robust, low-power, stable, and light weight, active     knee prosthetic device that can dramatically increase gait symmetry and walking economy of a     transfemoral amputee during walking.      State of the art prosthetic knees can be classified into three main classes: a) mechanically     passive, b) variable-damping, and c) powered. Although the devices within each of these     classes offer some advantages for above-knee amputees, their overall performance still     presents some deficiencies. Artificial knees in the first two groups are predominantly     damping devices, incapable of providing positive power output. Moreover, current powered     prostheses are heavy and inefficient in their energy consumption, and/or they have a limited     range of motion. To overcome such inadequacies, we have designed a novel prosthetic knee     device with a biomimetic approach.      The design of the active knee prosthesis is inspired by the antagonistic muscle anatomy of     the human knee joint. This device mimics the synergistic muscle activity at the knee using a     double series-elastic actuator (SEA) system that resembles the major mono-articular muscle     groups that help flex and extend the knee joint. The agonist-antagonist SEA knee architecture     will allow for precise force control of the knee joint, mimicking the spring-like behavior of     the human knee, as well as providing adequate energy for forward progression of the body. The     SEA has been previously developed and tested on legged robots. Also, the SEA has been     successfully applied to the development of an actuated ankle-foot orthoses (AAFO) at MIT AI     Lab.      The mechanical architecture of the active knee prosthesis allows for independent engagement     of flexion and extension tendon-like, series springs for the control of joint position and     impedance, as well as net joint torque. Furthermore, this architecture permits a joint     rotation with near zero friction, allowing the controller to take advantage of the passive     dynamics of the system, thus, augmenting the overall energetic efficiency of the system.   "
222980|NCT00771602|"     The goal of this clinical research study is to find out how well Campath (alemtuzumab),     Rituxan (rituximab), or a combination of the 2 drugs may control Chronic Lymphocytic Leukemia     (CLL) that is left after chemotherapy. The safety of these drugs will also be studied.   "
222981|NCT00771615|"     The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK     1557484A is immunogenic when given to adults aged 18-64 years.   "
223027|NCT00772213|"     Controlled clinical intervention study comparing the treatment of multiple trauma patients in     a newly developed combined diagnostic and operation room, the multifunctional image guided     therapy suite (MIGTS) versus controls. The MIGTS proved to significantly accelerate the     procedure and led to more satisfied team members.   "
223338|NCT00774111|"     A study in healthy volunteers to determine whether there is a drug interaction between     GSK1349572 and etravirine   "
222982|NCT00771628|"     Patients presenting for elective surgery requiring tracheal intubation will be randomized to     one of two different ETT stylets. The primary outcome is time to intubation.      The null hypothesis is that there will be no difference.      The GlideScope video laryngoscope (Verathon) is a widely used intubating device that uses a     high-resolution camera embedded into a plastic laryngoscope blade. An LED provides     illumination. The GlideScope often provides a good laryngoscopic view, but passing the     endotracheal tube (ETT) through the vocal cords is sometimes difficult. Because of the 60     degree anterior curvature of the GlideScope's blade, ETT's must have stylets inserted so that     the ETT distal tip can be positioned anteriorly. Various authors have recommended different     angles of the ETT to optimally place it into the trachea, including matching the GlideScope's     60 degree angle, or configuring the ETT with a 90 degree bend. Previous studies demonstrated     that 90 degree sharp bend was both faster and subjectively easier in a heterogeneous group of     intubators. With the introduction of the Flex-It stylet by Parker Medical, the question     arises as to the the best configuration of stylet for the ETT. Therefore, this prospective,     randomized, single-blinded trial is proposed.   "
222983|NCT00771641|"     RATIONALE: Patient abstract not available      PURPOSE: Patient abstract not available   "
222984|NCT00771654|"     This is a prospective, randomized, double-blind controlled trial. The goal is to show whether     the administration of daily oral Phentermine will augment patient weight loss and resolve     obesity associated comorbidities following gastric band operation.   "
222985|NCT00771667|"     A medical research study in adult patients who have moderate to severe Crohn's disease     designed to determine whether or not treatment with an experimental drug called ustekinumab     (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of     Crohn's disease.   "
222986|NCT00771680|"     This study is conducted in Europe and Asia. The aim of this observational study is to     evaluate the effectiveness and the incidence of serious adverse reactions while using     Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used     insulin previously under normal clinical practice conditions.   "
222987|NCT00771693|"     The postprandial phase in diabetic patients is characterized by a rapid increase in blood     glucose levels, increase in platelet aggregation, LDL oxidation and over production of     thrombin.      The aim of the study is to determine whether meal induced platelet activation is related to     post-prandial hyperglycemia, and can be attenuated by good postprandial glucose control with     rapidly acting insulin in patients with T2DM.   "
222988|NCT00771706|"     Cough is both an important physiologic component of lung defense and a cardinal indicator of     disease. For those with chronic cough, defined as cough lasting for more than 3 weeks, the     differential diagnosis is broad, including self-limited, persistent, and chronic diseases.     The success of a given treatment depends upon a proper diagnosis, yet this is often not     obvious. Gastroesophageal reflux (GER) has been proposed as one possible etiology of a     chronic cough in a number of studies in the adult literature; nevertheless a clear cause and     effect remains to be confirmed as there continues to be no gold standard test definitively to     identify pathologic GER. Each year, billions of dollars are directed towards diagnosing and     treating GER as it relates to adults and children with a chronic cough but without solid     proof of effect.      We propose to test the null hypothesis that there is no causative role of GER with regards to     the etiology of chronic cough in children. If the null hypothesis proves true, this has     important medical and economic ramifications, as it would suggest that treatment of acid     reflux for chronic cough in a child is unwarranted. With this conclusion, health care costs     would be reduced and children spared inappropriate medication.   "
222989|NCT00771719|"     The purpose of this research study is to measure the levels of ceftobiprole in the blood,     urine and tissues of the lungs during and after administration of four doses of ceftobiprole.     Safety of the drug will also be evaluated.   "
222990|NCT00771732|"     To see if four sessions of light therapy successfully treats nail fungus.   "
222991|NCT00771745|"     To determine how safe and effective giving Thymoglobulin before transplantation to patients     who are going to be receiving kidney transplants.   "
222992|NCT00771758|"     The purpose of this study is to determine the effectiveness and safety of tapentadol     immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain     caused by vertebral compression fractures (VCF) associated with assumed osteoporosis for whom     treatment with oral opioid analgesics is appropriate.   "
222993|NCT00771771|"     The main purpose of this study is to evaluate the benefit of early supported discharge (ESD)     in rehabilitation of stroke patients in two different outpatient modalities.      In a collaborating study, changes in physical function as well as the patients' own     perception of physical function, pain and fatigue will be studied. In further collaborating     studies, health economics and organizational issues will also be evaluated.   "
222994|NCT00771784|"     The length of tracheal intubation may affect the subsequent ventilation with a laryngeal mask     during percutaneous tracheostomy.   "
222995|NCT00771797|"     To assess the clinical efficacy and to simultaneously explore the underlying molecular     mechanisms of the beneficial effects of flavanol-rich cocoa on vascular function diabetic     patients with peripheral artery occlusive diseases (PAOD) of the lower extremities will be     investigated.   "
222996|NCT00771810|"     This research study will investigate the safety and effectiveness of two different dose     levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine     and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian     cancer. This experimental drug is called TXA127 and is being tested for effectiveness to see     if it will help reduce some of the side effects of the chemotherapy, primarily low blood     platelet levels that lead to excess bleeding. This study also intends to test the safety of     TXA127 when given as an injection under the skin on a daily basis concurrently with up to 6     cycles of the prescribed chemotherapy.   "
222997|NCT00771823|"     A placebo controlled study of the impact on insulin sensitivity and lipid profile of     maraviroc 300 mg twice daily in HIV negative male volunteers.   "
223028|NCT00772226|"     The study is undertaken to investigate whether relaxing music therapy before, during and     after laparoscopic cholecystectomy has any effect on pain, PONV or fatigue and level of     stress as measured by Cortisol and C reactive protein.      Patients will be scored according to those endpoints 1 and 3 hours after surgery and on day 1     and 7 post-OP.   "
222998|NCT00771836|"     Background: Stem cell transplantation (SCT) is associated with pulmonary complications and     may lead to high morbidity and mortality. We encountered several children post-SCT with a     clinical picture suggestive of airway hyper-reactivity (AHR) and evidence of reversible     airway obstruction that was not reported pre-transplant. Our aim was to determine if SCT     induced AHR as assessed by methacholine challenge test (MCT) and to determine any correlation     between AHR and pulmonary complications.      Methods: Prospective study evaluating consecutive patients referred for SCT to the Department     of Pediatric Hemato-Oncology at Meyer Children's Hospital. Evaluation included pulmonary     function test and methacholine challenge test before and after the transplantation, and     assessment of pulmonary complications.   "
222999|NCT00771849|"     The study investigated safety profile and the antibody responses to an experimental     tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have     received a monovalent meningococcal C conjugate vaccine at least one year previously.      Primary objective:      To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C     in participants receiving Menactra® to the serogroup C antibody response in a control group     of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28     days following vaccination.   "
223000|NCT00771862|"     The purpose of this research study is to determine if putting local anesthetic through one or     two percutaneous catheters placed next to the nerves that go to an amputated limb will     decrease long-term pain in the amputated limb.   "
223001|NCT00771875|"     This study is being conducted to determine how safe and effective using an immune cell (b     cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are     experiencing certain types of rejection.   "
223002|NCT00771888|"     Positive data originating from two polycystic liver patients treated with somatostatin     analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated     polycystic livers and no other therapeutic options were available.      Patients who participated in LOCKCYST trial are able to benefit from active treatment.     Participants will be actively treated for 24 weeks.   "
223003|NCT00771901|"     Normally, the hormone insulin works to help keep blood sugar normal. However, as a person     gains weight, insulin does not work as well and blood sugar tends to be a little higher than     normal. This is called insulin resistance.      Two investigational drugs (not approved by the Food and Drug Administration) for the     treatment of high lipid levels or insulin resistance are being examined in this study: one     drug is called tauroursodeoxycholic acid (TUDCA), the other is called sodium phenylbutyrate     (PBA). This study is designed to test if TUDCA and/or PBA is effective in people who are     obese with insulin resistance and high lipids. We hypothesize that pharmacologically-induced     decreases in ER stress will improve insulin action and hepatic lipid metabolism in obese     subjects.   "
223004|NCT00771914|"     The purpose of this study is to determine if omega-3 fatty acids enhance the antiplatelet     effects of aspirin.   "
223005|NCT00771927|"     SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the     long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in     patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on     current therapy. Using reported adverse events, the incidence of certain cardiovascular and     psychiatric events will be evaluated.   "
223006|NCT00771940|"     The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and     lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that     ghrelin infusion causes insulin resistance and lipolysis.   "
223007|NCT00771953|"     The primary objective is to determine the anti-tumor activity of the combination of apricoxib     + either docetaxel (AP/DC) or pemetrexed (AP/PE) compared with placebo + either docetaxel     (P/DC) or pemetrexed (P/PE) as measured by progression free survival in patients with Stage     IIIb (pleural effusion)or Stage IV non-small cell lung cancer (NSCLC).   "
223008|NCT00771966|"     The optimal amount of fluid a patient need under surgery is not clear. Both to much and to     little fluid can damage the organ functions.      A strategy called Goal directed therapy, where the fluid amount a patient need is guided by     the stroke volume, has shown to minimize post-operative nausea and vomiting.      The investigators intend to investigate if patients treated after these standards, has a     better outcome then patients treated after normal regimes, regarding post-operative     orthostatic-intolerance.   "
223009|NCT00771979|"     The aim of the study is to compare how different formulations of AZD0530 are absorbed by the     body. As for all clinical trials, safety and tolerability of the drug will be evaluated.   "
223010|NCT00771992|"     The effect of surfactant protein D under native and altered conditions will be investigated     in immune cells that are derived from bronchoalveolar lavage in patients with allergic asthma     following segmental allergen challenge. The goal of this study is to elucidate the pro-     versus anti-inflammatory function of SP-D molecules and to identify motifs of SP-D that have     treatment potential in allergic asthma.   "
223011|NCT00772005|"     The primary objective of the study is to evaluate whether armodafinil treatment is more     effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the     negative symptoms of schizophrenia   "
223012|NCT00772018|"     RATIONALE: Learning about quality of life and symptom management in patients with bladder     cancer may help doctors learn about the effects of treatment and plan the best treatment.      PURPOSE: This clinical trial is studying of quality of life and symptom management in     patients with bladder cancer.   "
223013|NCT00772031|"     The purpose of this study is to compare the reduction in the number of severe headache days     at six months in people with chronic migraine treated with topiramate and propranolol versus     those treated with topiramate and a placebo.   "
223029|NCT00772239|"     Cardiac surgery is bleeding requiring transfusion surgery .      The haemorrhagic is related to the need to use high doses of anticoagulants to prevent     thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors     consumming despite conducting a thorough anticoagulation.      All these changes contribute to increase the need for transfusions during heart surgery.      The main objective of this study is to compare the need for transfusions in patients     suffering from bleeding complications after cardiac surgery with a therapeutic algorithm     based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests.      100 pateinst (50 in each arm) should be included in this trial.   "
223014|NCT00772044|"     Primary Endpoints:      •Comparison of difference in AHI at one-week in-lab polysomnography between device on and     device off nights, controlling for sleep position (supine vs. non-supine)      Secondary Endpoints: By polysomnography, reduction in:        -  AHI with device on vs. off at 3 months, controlling for sleep position        -  Oxygen desaturation index with device on vs. off        -  Arousal index with device on vs. off        -  Duration of snoring with device on vs. off        -  Epworth Sleepiness Scale      Patient acceptance, in terms of:        -  Refusal rate at screening        -  Discontinuation rate during follow-up        -  Daily compliance rate        -  Device-related adverse events        -  Serious adverse events   "
223015|NCT00772057|"     Background and Aims: The efficacy of portal pressure reduction by beta blockers for the     management of small (≤5 mm) esophageal varices in patients of cirrhosis is not clear. The     present randomized controlled trial aims to address these issues. The investigators also     assessed the utility of serial HVPG measurements in these patients.      Patients and Methods: Consecutive patients with cirrhosis with small varices, with no history     of variceal bleed, were randomized to receive propranolol or placebo. These patients were     further randomized to undergo no HVPG, only baseline HVPG, or serial HVPG measurement.     Propranolol was titrated to reduce heart-rate to 55/min.   "
223045|NCT00772447|"     The objectives of this study is to evaluate the Safety and Efficacy of Intravenous Daptomycin     (Cubicin®)Compared with that of Comparator (Vancomycin or Vancomycin Followed by     Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects with Complicated     Bacterial Skin and Skin Structure Infection due to Gram-Positive Pathogens.   "
223016|NCT00772070|"     This study was designed to simulate meningococcal challenge by vaccination with a fractional     combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in     children who were vaccinated with one dose of TetraMenD at least 18 months earlier.      Primary Objective:      To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants     who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine     to those responses in participants who received the same reduced dose of Menomune® but had     not previously received any meningococcal vaccine.   "
223017|NCT00772083|"     Blood donors are a precious community resource. Each month at Blood Center of Wisconsin     (BCW), 200 men and 600 women over age 50 are turned away (deferred) because of anemia. In     those over 50, anemia may signal serious underlying disease such as colorectal cancer (CRC).     CRC is the #3 cause of cancer death in Wisconsin with more than 1,000 deaths in 2006. Yet     with proper testing CRC outcomes can be improved by early diagnosis. This project will focus     on a population of deferred older blood donors to develop and test educational materials that     will motivate donors to seek medical attention for their anemia, so that the underlying cause     is diagnosed and treated. This project has the potential to lead to better CRC outcomes in     Wisconsin blood donors.   "
223018|NCT00772096|"     Delirium and long-term cognitive dysfunction are important problems in intensive care     patients. Patients with sepsis are at a high risk of developing delirium (septic     encephalopathy), which may be an important risk factor for the development of long-term     cognitive dysfunction.      Working hypotheses: 1. Septic encephalopathy and cognitive dysfunction are caused by an     unspecific reaction of the brain to an intense inflammatory stimulus. 2. It is possible to     therapeutically influence the inflammatory response and its effects on the brain.   "
223019|NCT00772109|"     This study is designed to test lot consistency of three different manufacturing lots and to     generate safety and immunogenicity data of the investigational vaccine administered via the     ID route.      Primary Objective:        -  To demonstrate lot consistency of the Fluzone ID manufacturing process.        -  To provide information concerning the immune response of Fluzone ID.      Secondary Objectives:      Safety        -  To describe the safety profile of subjects who receive of Fluzone ID.   "
223020|NCT00772122|"     In order to investigate the effectiveness of G-CSF in preventing embryo demise, the     investigators administered this cytokine to women with recurrent miscarriage in a randomized     controlled study compared to women treated with placebo. Sixty eight women with unexplained     primary recurrent miscarriage, all of them with at least four consecutive abortions and     negative for all clinical investigations were selected for this study. Patients were randomly     treated with G-CSF, starting on the 6th day after ovulation, or with placebo.   "
223021|NCT00772135|"     The purpose of this study is to determine whether oral sildenafil citrate reduces the     abnormal right ventricular pressure response during exercise in adolescent and adult patients     with specific types of congenital heart defects.   "
223022|NCT00772148|"     The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of     medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf®     capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a     transplanted kidney and liver. LCP-Tacro is a tablet containing the same active ingredient     (tacrolimus) that is in Prograf capsules, but the tablet has been designed to release     tacrolimus over an extended period so that it only has to be taken once daily. LCP-Tacro is     an investigational drug.      This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a     liver transplant in patients randomly assigned (by chance, like flipping a coin) to take     either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In     addition, patients will remain on study drug for 360 days in order to evaluate the relative     safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.   "
223023|NCT00772161|"     This study is designed to provide pharmacokinetic data for the assessment of bioequivalence     of Ritalin LA formulation compared to Medikinet ret. concerning plasma levels and efficacy     measures.      The primary objective of the study is to determine the pharmacokinetic parameters and     bioequivalence of Ritalin LA compared to Medikinet retard, both given as oral o.d. doses of     20 mg over 7 days in children with ADHD. The secondary objectives are to assess the efficacy,     safety and tolerability of Ritalin LA and Medikinet retard and the association of these     parameters with plasma levels.   "
223024|NCT00772174|"     The purpose of this study was to determine the efficacy of pioglitazone taken with metformin     on high-density lipoprotein cholesterol in subjects with Type 2 Diabetes.   "
223025|NCT00772187|"     Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We     would like to compare different analgesic methods.   "
223026|NCT00772200|"     This research trial studies neuropsychological (learning, remembering or thinking) and     behavioral testing in younger patients with cancer. Collecting information over time from a     series of tests may help doctors develop effective tests to measure neuropsychological and     behavioral function of patients with cancer.   "
223030|NCT00772252|"     Background: In patients undergoing hemodialysis or hemofiltration will suffer from the injury     of reactive oxidative species. Oxidative stress will affect cell membrane, protein, and DNA.     It will damage the cell and result in organ dysfunction. We believe that in patients, who     have acute hepatic failure, undergoing plasma exchange or Molecular Absorbent Recirculating     System for bridge therapy will suffer from the injury of reactive oxidative species, too. It     will damage the kidney, lung, cerebral cortex, and other organs. It may result in death     before the recovery of liver function or undergoing liver transplantation.      Aims: 1. Investigate the severity of oxidative stress and risk factors of high oxidative     stress in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent     Recirculating System. 2. Investigate the microcirculation status and risk factors in acute     hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating     System. 3. Study the relationship between oxidative stress and microcirculation status. 4.     Study the correlation between oxidative stress and prognosis. 5. Study the correlation     between microcirculation status and prognosis.   "
223031|NCT00772265|"     The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard     to its total and to its maximum serum insulin concentrations.   "
223032|NCT00772278|"     Purpose of this study:      Primary:      • Comparison of cardiovascular mortality and morbidity which includes cardiac and     neurological morbidity (TIA and CVA) in the two invasive treatments of asymptomatic carotid     artery stenosis      Secondary:        -  Comparison of non cardiovascular morbidity caused by the two invasive techniques             1. morbidity at the site of incision (infection or local hematoma)             2. damage to cranial nerves (hypoglossus, vagus)             3. brain hyperperfusion which is defined as severe headache which is not responsive to               analgesics with or without nausea and vomiting.             4. events of bradycardia within the first 24 hours, clinically evident and/or silent        -  microembolic brain events immediately after the procedure and their relationship with          morbidity and/or mortality due to TIA's or CVA's        -  the change in the stenotic carotid artery at the time of follow up with duplex of neck          arteries        -  the comparison of the affect of the two procedures on patient life style   "
223033|NCT00772291|"     Nowadays, chronic pain mainly as a result of iatrogenic nerve damage is generally considered     as the most frequent complication after inguinal hernia surgery. The primary objective of     this randomised double-blind placebo-controlled trial is to investigate whether pregabalin     reduces pain in patients with chronic pain of neuropathic origin after herniorraphy.   "
223034|NCT00772304|"     To compare patient perceptions of the sensory attributes, including taste and aftertaste, of     Olopatadine relative to azelastine when administered as a single dose in patients with     allergic rhinitis.   "
223035|NCT00772317|"     For the treatment of locally recurrent prostate cancer following failed external beam     radiation therapy (EBRT)   "
223036|NCT00772330|"     Assess the safety and performance of the Miami InnFocus Drainage Implant in patients     suffering from glaucoma that is inadequately controlled on tolerated medical therapy with     intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg.   "
223037|NCT00772343|"     Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine     versus placebo in the 9 week period after the third dose of the study vaccine in subjects     with first episode of CDI receiving antibiotics standard of care.      Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus     placebo in subjects with first episode of CDI receiving antibiotics standard of care.   "
223038|NCT00772356|"     This crossover, glucose-clamp study will investigate the impact of different basal insulin     infusion rates on glucose control employing insulin pumps with different insulin delivery     regimen. Patients will be randomized in one of 2 groups, to receive on the first study day     insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day     they will be switched to treatment with the alternative delivery regimen. The anticipated     duration of the trial is 2 study days and the target sample size is 14 individuals.   "
223039|NCT00772369|"     The purpose of this survey is to collect selected safety data.      Primary Objective:      To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.   "
223040|NCT00772382|"     The primary objective of this study is to demonstrate the long-term safety and tolerability     of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with     hyperphosphatemia.      The secondary objective of this study is to assess the long-term efficacy of flexible doses     of MCI-196.   "
223041|NCT00772395|"     Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after     uncemented total hip arthroplasty?   "
223042|NCT00772408|"     Infection with Mycobacterium tuberculosis remains at epidemic levels globally. Innate and     adaptive immune responses evolve as protective mechanisms against mycobacterial infection in     humans. Toll-like receptors (TLRs) are transmembrane proteins characterized by an     extracellular leucine-rich domain that participates in ligand recognition and an     intracellular tail. TLRs are the first defense system to detect potential pathogens, initiate     immune responses and form the crucial link between innate and adaptive immune systems.     Stimulation of TLR initiates a signaling cascade that involves a number of proteins, such as     MyD88 and IL-1 receptor-associated kinase. This signal cascade leads to NF-κB activation,     which induce the secretion of pro-inflammatory cytokines.      TLR2 is a family of TLR family and has been reported to be the principle mediator of     macrophage activation in response to mycobacterium. Growing amounts of data suggest that the     ability of certain individuals to respond properly to TLR ligands may be impaired by single     nucleotide polymorphisms (SNPs) within TLR genes, resulting in an altered susceptibility to,     or course of, infectious disease. The genetic polymorphism of TLR2 (arginine to glutamine     substitution at residue 753 (Arg753Gln)) has been associated with a negative influence on     TLR2 function, which may, in turn, determine the innate host response to mycobacteria. In     addition, another polymorphism (Arg677Trp) of the TLR2 was reported to be associated with     susceptibility to tuberculosis in Tunisian patients. Moreover, in Mycobacterium leprosy     patients with TLR2 mutation (Arg677Trp), production of IL-2, IL-12, IFN-gamma, and TNF-alpha     by M. leprae-stimulated peripheral blood mononuclear cell were decreased compared with that     in groups with wild-type TLR2.      To date, there have been no studies of the association of SNPs of TLR2 with cytokine profiles     and clinical outcomes on M. tuberculosis. We hypothesize that polymorphisms in the TLR2 are     associated with :        1. increased prevalence of active pulmonary TB infection,        2. altered levels of pro-inflammatory and anti-inflammatory cytokines in serum,        3. clinical outcomes and presentations. We thus design a prospective case-control study to          test this hypothesis. The frequency of TLR2 polymorphisms in both pulmonary TB patients          and healthy controls will be determined by polymerase chain reaction-restriction          fragment length polymorphism. Serial serum levels of IL-12, IFN-γ, and IL-10 in          pulmonary TB patients with or without TLR2 polymorphisms will be measured by enzyme          linked immunosorbent assay. Relationships between TLR2 polymorphisms and serum cytokines          dynamics or clinical outcomes will be analyzed.   "
225800|NCT00808288|"     To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung     disease (COPD)   "
223043|NCT00772421|"     The primary objective is to demonstrate that a higher proportion of responders to deep brain     stimulation (DBS) in the anterior nucleus (AN) of the thalamus in refractory epilepsy     patients in the SANTE study exhibit a recruitment rhythm relative to non-responders.   "
223044|NCT00772434|"     A wide variety of individuals are at risk for bleeding, but even though bleeding symptoms are     common it is difficult to compare different people's symptoms. Recent research has found that     carefully designed surveys can be used to calculate a bleeding score that is useful for     diagnosing bleeding disorders, but normal individuals have not been specifically studied in     large numbers with a comprehensive survey. Whether factors like race, ethnicity, age, sex,     aspirin use, and previous trauma and surgery influence bleeding scores is also unknown. The     primary goal of this study is to use a comprehensive computerized questionnaire to record the     bleeding symptoms of normal individuals and then assess the range and severity of bleeding     symptoms in this normal population.      Secondary goals include determining whether race, ethnicity, age, sex, aspirin use, and     previous trauma and surgery correlate with bleeding symptoms.   "
224156|NCT00779389|"     The central hypothesis to be tested in this study is that dual blockade of EGFR and Src     pathways or proteins are distinct compared to inhibition of either kinase alone in head and     neck and lung cancers.   "
223046|NCT00772460|"     Two patient warming systems will be compared with 40 patients each in a convective warming     group (BairHugger, Arizant) and in a conductive warming group (HotDog, Augustine Biomedical).      The patients will undergo small to medium trauma surgery and will be warmed with the     randomized device - the hypothesis is, that the area under the standardized core temperature     / time curve is significantly greater in the conductive warming group. Secondary outcome is     the mean skin temperature / time area under the curve.   "
223047|NCT00772473|"     To assess CGRP levels in saliva through the evolution of migraine.   "
223048|NCT00772486|"     The study is a Phase 1b open label, non-randomized, single institution clinical trial that is     designed to evaluate the safety and tolerability of three repeat infusions of ISF35 followed     by a standard regimen of three cycles of fludarabine, cyclophosphamide and rituximab (FCR) in     subjects with refractory, resistant, and/or 17p- CLL.   "
223049|NCT00764582|"     Compare the corneal penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients     undergoing penetrating keratoplasty (PK)   "
223050|NCT00764595|"     RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how     well it works in treating patients with liver metastasis from a gastrointestinal stromal     tumor.   "
223051|NCT00764608|"     Numerous organisms live on and in healthy human skin. This study seeks to survey the     diversity of this complex ecosystem by collecting samples from approximately 1000 individuals     in order to determine the type of organisms living on their skin.   "
223052|NCT00764621|"     Patients with a history of colorectal cancer and known or suspected liver metastases who are     scheduled for contrast-enhanced tomographic imaging will be included in this study. After     randomization to either Primovist-enhanced MRI, extracellular contrast media (ECCM)-enhanced     MRI or contrast-enhanced (CE)-CT outcomes and resource needs of the diagnostic work-up and     treatment will be evaluated for each of the three imaging modalities. Main objectives of the     study are to assess the proportion of patients for whom further imaging is required to come     to a therapy decision and to evaluate the proportion of patients with intraoperatively     modified surgical plans after Primovist-enhanced MRI as compared to ECCM-enhanced MRI and     CE-CT.   "
223053|NCT00764634|"     This Phase 2 study is a double blind, placebo-controlled, randomized, multicenter     investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different     three-dose dosing schedules.   "
223054|NCT00764647|"     The purpose of this evaluation was to determine the effectiveness of an educational program     designed to assist family caregivers to learn the knowledge and skills to take better care of     their frail elder relatives and themselves.   "
223055|NCT00764660|"     The purpose of this study is to assess the effects of SCH 900435 (Org 25935, MK-8435) on     heavy drinking, safety and tolerability of SCH 900435 in participants with alcohol     dependence.   "
223056|NCT00764673|"     The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™     system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic     implant in the knee. Each knee will be designated as a separate subject and followed for a     period of 2 years.   "
223057|NCT00764686|"     Ankylosing Spondylitis(AS) is a chronic, inflammatory, rheumatic disease (Khan, 2002). AS is     associated with increased work disability and use of healthcare resources (Ward et al, 2008).     Evidence suggests that group exercise is the most effective form of physiotherapy management     for individuals with Ankylosing Spondylitis (Dagfinrud et al, 2008). To date, no research has     been published in relation to short, intensive group exercise programmes.      This study aims to investigate the effects of a five day exercise and education programme for     individuals with Ankylosing Spondylitis. Effects of the programme on disease activity,     function and spinal mobility will be measured using using validated quantitative measures;     the overall value of the programme for patients will be explored by means of semi-structured     interviews.   "
223085|NCT00765050|"     The primary objective is to analyze the safety and efficacy of CD133+ cells, obtained from     peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.      The secondary objectives are:        -  To determine the safety of the intramuscular administration of CD133+ cells that have          been mobilized from peripheral blood.        -  To determine the CD133+ capacity to increase the re-vascularization at lower limbs in          diabetic patients with critic ischemia in the lower limbs.        -  To evaluate the patient global health condition using the notified results of the SF-36          questionnaires completed by patients   "
223086|NCT00765063|"     The primary objective of this 6 month open-label extension trial is to evaluate long-term     safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in     diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral     neuropathy.   "
223087|NCT00765076|"     This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine     GSK2186877A in people aged 65 years or older.   "
223058|NCT00764699|"     Patients with Crohn disease often have poor weight gain and short stature, yet the etiology     of the poor growth is not well defined. Studies in chronically ill patients who do not have     Crohn disease have suggested that inflammation causes IGF-1 deficiency due to inadequate     IGF-1 generation. Previous studies of GH use in Crohn patients have demonstrated improvement     in linear growth, weight and bone mineralization. However, GH can cause glucose intolerance     in chronically ill children, particularly those who require treatment with corticosteroids.     Recently the FDA has approved recombinant IGF-1 (rhIGF) for treatment of IGF-1 deficient     short stature. This medication has not been studied in Crohn disease. The purpose of this     study is to test the hypothesis that poor growth in Crohn disease is associated abnormal     IGF-1 generation which leads to poor linear growth, decreased weight and osteoporosis and     that replacement of IGF-1 with rhIGF will correct growth and improve bone density. To test     our hypothesis we will recruit 20 patients with Crohn disease from our pediatric     gastroenterology practice. Each will have been previously diagnosed with Crohn disease for a     minimum of one year and will be studied at baseline and six month intervals for one year     while on treatment with Increlex.   "
223059|NCT00764712|"     A randomized trial to compare three insulin-titration protocols for tight glycemic control in     surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath)     protocol, and an enhanced model predictive control algorithm (eMPC)   "
223060|NCT00764725|"     The Swefot trial was designed to compare two treatment strategies for patients with early     rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of     traditional antirheumatic medications (DMARDs), versus a combination including a newer     biological anti-TNF medication. In order to make this trial consistent with current     practices in rheumatology, all patients were first given the most commonly used antirheumatic     medication, methotrexate (MTX). After 3-4 months those patients who had not responded     adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus     hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed     patients who could not tolerate one of the added medications to switch in treatment - but     keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be     replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial     was the percentage of patients who, after one year of treatment, achieved a good response     as defined by Eular.   "
223061|NCT00764738|"     Visual outcomes using monthly ranibizumab therapy are well established in clinical trials,     but the best way to assess when and how to treat patients with PRN therapy has not been     proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with     ranibizumab therapy. Additionally, VA and OCT outcomes don't always correlate and other     assessments such as the Multi-focal ERG and microperimetry may be useful as early predictors     of when patients should be retreated. This study will assess 2 groups (monthly and PRN     therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes. For     the PRN group retreatment will be based on OCT criteria. We will investigate if     microperimetry or multifocal ERG would have been an early predictor of fluid recurrence.   "
223062|NCT00764751|"     This study will compare the efficacy and safety of once daily treatment of LEO 19123 cream     versus Dovonex® cream (applied twice daily) and versus LEO 19123 cream vehicle alone (applied     twice daily) in subjects with psoriasis vulgaris. Subject will be treated for 4 weeks. All     subjects will apply LEO 19123 cream to psoriasis lesions on the left or right side of the     body and either Dovonex® cream or cream vehicle to lesions on the other side.   "
223063|NCT00764764|"     The purpose of this pilot study is to conduct research to determine the most effective     physical therapy treatment for a condition called shoulder impingement. This condition occurs     when tissue in the shoulder is caught between the humerus (arm bone) and the scapula     (shoulder blade). This causes pain when one tries to reach overhead or behind the back.      Two treatment methods will be used in the study. The first method uses the traditional     treatments of hands-on shoulder stretching, shoulder exercise, posture, and education. The     second method will use the traditional methods of shoulder treatment in addition to treatment     of the cervical spine.      It is hypothesized that a group of patients between 40 and 70 years of age with signs and     symptoms of shoulder impingement who receive physical therapy to the cervical spine and     shoulder will report a higher level of functioning, will report less pain, and will gain more     range of motion than a group of patients receiving physical therapy solely to the shoulder.   "
223064|NCT00764777|"     The BRAVISSIMO trial wants to investigate in a controlled setting, the long-term (up to 24     months) outcome of the self-expanding nitinol Absolute Pro (Abbott Vascular) and the     balloon-expandable Omnilink Elite (Abbott Vascular) stent in TASC A&B and TASC C&D iliac     lesions. A separate analysis of both patient populations will be performed and listed.   "
223065|NCT00764790|"     The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline     Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine)     in children, 6 to 35 months of age.   "
223066|NCT00764803|"     The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™     system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data     collection is already under way.   "
223067|NCT00764816|"     Phosphorus is a substance in the blood that comes from food and is normally cleared from the     body by the kidneys. In patients with kidney disease, excess phosphorus may build up in the     body as you eat. This leads to problems with bones and blood vessels over time. In this     study, we will compare the blood and urine before and after eating one week of a diet with a     protein from plants (soy and grains) and before and after another one week of diet with     protein from animals (meat and dairy products). The amount of phosphorus that the kidney puts     out in the urine, and the changes in blood hormones in response to the diet will be measured     at the beginning and end of each week on the two diets.   "
223068|NCT00764829|"     We are interested in patient-specific factors that may affect the balance of recipient cells     and donor cells in patients who receive stem cell transplants. We will look at the way the     patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these     two drugs affect the patient's body.   "
223069|NCT00764842|"     The purpose of this study is to evaluate the survivorship and efficacy of the Encore CLP® Hip     stem in a group of no more than 200 patients from whom data has already been collected.   "
223070|NCT00764855|"     Sleeping medication and analgesia are standard administered during anesthesia. Sleeping     medication, Propofol (Diprivan, AstraZeneca), and analgesia, Remifentanil (GlaxoSmithKline),     are most frequently used In the University Hospital Ghent.      The clinical effect of administration of pharmaca can be measured in the changes of     heartbeat, blood pressure, respiration and the changes of brain activity by registering EEG.     These measurements are performed standard, to secure the safety of the patient.      The heartbeat and the EEG will be measured by non invasive adhesive electrodes on the skin of     the patient.      The blood pressure will be measured by non invasive blood pressure cuff around the arm and     the respiration parameters will be measured by non invasive spirometry, which are all     standard available on a anesthesia device.      Most of the pharmaca are administered by a fixed dosage schedule based on the patient's     weight.      A more individualized administration of this pharmaca could lead to a better anesthesia     quality.      Since considerable time, we know that a computer-controlled administration of these products     by automatic coupling between the measured effects and the spuitpump to administer the     product, could lead to a better administration, optimalisation of the administered dose,     because the patients individual effect of the administration can be taken in consideration.     This device is called the closed-loop system. The department of Anesthesia has already     proofed the utility of the device for automatic administration of Propofol and opiates in     small specific patient groups.   "
223072|NCT00764881|"     The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering     from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no     longer than one year will express the same level of sexual distress when taking SH T00658ID     compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.   "
223073|NCT00764894|"     The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee     System in a group of 200 patients for whom data has already been collected.   "
223074|NCT00764907|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. A donor stem cell transplant may     replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-tumor effect). Giving combination chemotherapy before the transplant helps stop     the growth of cancer cells and stop the patient's immune system from rejecting the donor's     stem cells. It is not yet known which combination chemotherapy regimen is more effective in     treating young patients with acute lymphoblastic leukemia.      PURPOSE: This randomized phase III trial is studying different risk-adjusted combination     chemotherapy regimens in treating young patients with acute lymphoblastic leukemia.   "
223075|NCT00764920|"     The purpose of this research is to develop non-invasive imaging modalities for assessment of     skin. This is a pilot study which will use multiple imaging modalities to collect information     on normal and lesional skin. The researchers understand that the purpose of this study is not     to evaluate any particular treatment and an investigation of a new therapeutic intervention     would require an additional protocol. Skin conditions to be studied include vascular lesions,     pigmentary disorders, inflammatory conditions and neoplasms.   "
223076|NCT00764933|"     The purpose of this study is to test whether a structured information program at the     beginning of the ICU-stay is effective to reduce ICU related anxiety and discomfort.   "
223077|NCT00764946|"     A study to test the safety and effect of twice daily raltegravir in a diverse cohort of     patients currently infected with human immunodeficiency virus (HIV), where at least 50% are     African American and at least 25% are female, either having received antiretroviral drugs     before or not.   "
223078|NCT00764959|"     The purpose of this study is to evaluate the use and efficacy of the Encore Linear™ Hip     System in a group of 200 patients for whom data has already been collected.   "
223079|NCT00764972|"     This is a phase IB/II trial of sorafenib, a new tyrosine kinase inhibition of multiple genes     that is active against renal cancer, plus vinorelbine, a chemotherapy agent active in breast     cancer.      The investigators are combining these 2 drugs in order to determine if the investigators can     increase the activity of vinorelbine in metastatic breast cancer patients.      Patients with measurable metastatic breast cancer without previous chemotherapy for     metastatic disease are eligible for the protocol. They will be treated with 2 different dose     levels of sorafenib in order to determine the most tolerable dose.   "
223080|NCT00764985|"     The investigators want to look at how patients admitted after passing out (syncope) or nearly     passing out (pre-syncope) do after going home and how many of them remain free of symptoms of     syncope or pre-syncope.   "
223081|NCT00764998|"     The purposes of this research study are:        1. to see if there is a difference in the quantity of protective influenza antibodies          produced by different doses of the Fluviral vaccine        2. to see if these different vaccine dosing schedules reduce flu-like illness and/or reduce          laboratory documented influenza in HIV Infected adults.   "
223082|NCT00765011|"     A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of     Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment     With TPF Chemotherapy.   "
223083|NCT00765024|"     A prospective controlled trial to compare the efficacy and safety of 7-day albendazole,     single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic     strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.   "
223084|NCT00765037|"     The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse     Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has     already begun.   "
223103|NCT00765284|"     To determine whether 8 weeks of Niaspan treatment increases cholesterol efflux in male     subjects with low HDL-C cholesterol when compared to no treatment.      To determine whether 8 weeks of Niaspan treatment increases fecal cholesterol excretion when     compared to no treatment.      To determine whether 8 weeks of Niaspan treatment increases the rate of global reverse     cholesterol transport when compared to no treatment.   "
223088|NCT00765089|"     Atrial Fibrillation (AF) is one of the most common postoperative complications after coronary     artery bypass grafting (CABG). Postoperative AF produces a substantial impact on hospital     resources with an estimated annual expenditure of over $1 billion. This includes the cost of     pharmacological treatment and the cost of the increased length of stay. The incidence of AF     is about 30-40% in CABG patients and increases with age of the patient. As the average age of     the patient that undergoes CABG surgery is increasing, it is critical to find a way to     prevent or reduce the incidence of this complication.      We propose a prospective, randomized, controlled study to determine the role of pulmonary     vein isolation by bipolar ablation in the prevention or reduction of postoperative AF. The     block- randomization plan will be used to maintain balance of the study and control arms     throughout the study.   "
223089|NCT00765102|"     This is a phase II, open-label, multicenter, dual-strata study designed to evaluate the     efficacy and safety of IV romidepsin given in combination with IV bortezomib for multiple     myeloma (MM) patients with refractory or relapsed disease. Patients will be enrolled into one     of two strata, bortezomib-resistant or bortezomib non-resistant.   "
223090|NCT00765115|"     To test that LY450139, a gamma-secretase inhibitor, will reduce the rate of newly synthesize     Amyloid Beta by determining the amount of newly synthesized 13C6 leucine-labeled Amyloid Beta     in lumbar cerebrospinal fluid from LY450139 treated subjects compared with placebo treated     subjects.   "
223091|NCT00765128|"     The purpose of this study is to determine whether continuous intravenous ketorolac infusion     reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone     disease.   "
223093|NCT00765154|"     The purpose of the study is to examine the effects of switching from antiretroviral     combinations that includes efavirenz (Sustiva®), lopinavir/ritonavir (Kaletra®) or     atazanavir/ritonavir (Reyataz®/Norvir®) in individuals experiencing side effects from one of     these agents, and replacing these with a new HIV medication called Darunavir also given with     ritonavir (Norvir®).      The study will primarily investigate the effect of change in medication on the subjects viral     load (the levels of the HIV virus in the blood), on immunological parameters (CD4 count) and     on other safety parameters (such as cholesterol) and also quality of life.   "
223094|NCT00765167|"     Training and calibration of dental examiners   "
223095|NCT00765180|"     The investigators previously reported that colonoscopy with a transparent retractable     extension (TRE) device improved the adenoma detection rate without affecting intubation and     withdrawal times. On the other hand, colonoscopy using narrow band imaging (NBI) is expected     to lead to higher rate s of adenoma detection. The investigators compared the effects of TRE     device on colorectal adenoma detection with those of NBI.   "
223096|NCT00765193|"     This will be a study where all patients will undergo a two-step procedure:      Step 1 - Physicians examine the problem area of skin ONLY and record result. Step 2 -     Physicians perform TBSE and record result. Eventual lesions suggestive of melanoma and     non-melanoma skin cancers will be recorded after step 1 or step 2 examination and will be     finally biopsied and histopathologically diagnosed. Exceptions to biopsy may include patients     with multiple non-melanoma skin cancers (e.g. actinic keratoses or basal cell carcinomas).      Each center will be provided with an electronic data sheet for patients record, or     alternatively, with a paper record form.      Endpoints of the study are new parameters concerning the standard of care for skin cancer     screening. We expect to conclude that TBSE enables clinicians discovering an increased number     of skin cancers thus resulting in earlier detection.   "
223097|NCT00765206|"     Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to     compare effects on stomach acid; 30 participants will continue treatment for 7 days and will     have repeat evaluations at Day 7.   "
223098|NCT00765219|"     The purpose of this study is to determine whether cognitive behavior treatment (CBT) can be     delivered effectively by providers of different expertise levels in adults age 60 and older     in a primary care setting.   "
223099|NCT00765232|"     The purpose of this study is to determine whether continuous intravenous ketorolac infusion     reduces pain in patients who are having laparoscopic surgery to donate a kidney.   "
223100|NCT00765245|"     RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the     cancer. It may also stimulate the immune system in different ways and stop cancer cells from     growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help     kill them or carry cancer-killing substances to them. It is not yet known whether     lenalidomide is more effective with or without rituximab in treating diffuse large B-cell     non-Hodgkin lymphoma.      PURPOSE: This randomized phase II trial is studying lenalidomide to see how well it works     when given with or without rituximab after standard chemotherapy in treating patients with     diffuse large B-cell non-Hodgkin lymphoma.   "
223101|NCT00765258|"     To examine, through retrospective and prospective chart review, the difference in pain and     mobility, pre and post treatment, as assessed by the patient's completion of the VAS pain     scale and Roland Morris Disability Questionnaire (RMDQ).      CT fluoroscopy guidance during percutaneous sacroplasty is an effective treatment for     sacro-iliac insufficiency fractures resulting in rapid reduction of pain and improved     mobility in patients. This can be effectively assessed using the VAS pain scale and RMDQ both     pre and post procedure.   "
223102|NCT00765271|"     The study is being conducted as we have found that many patients with Human Immunodeficiency     Disease (HIV) require a combination of different drugs to treat the HIV infection. Before     using different combination of drugs, it is important to do studies to see if the drugs will     affect the activity of one another.      The study aims to help us understand if darunavir/ritonavir or raltegravir have any effects     on levels of abacavir in the blood.      The purpose of the study is to assess the pharmacokinetics (how a drug is absorbed,     distributed and eliminated from your body) of abacavir in the absence and in the presence of     darunavir/ritonavir and raltegravir.   "
223129|NCT00765622|"     The purpose of this study is to demonstrate the importance of functional assessment of the     pelvic floor (AFA) in older women, as prognostic factor for Urinary Incontinence (UI).   "
223104|NCT00765297|"     Because the increasing fall problem, mainly due to an impaired gait and balance ability and     partly caused by trips, this study will investigate fall risk by detecting fall related     movement characteristics and by detecting stumbles inclusive the compensation mechanism to     recover from the trip. Based on the promising results using accelerometry for accurate and     objective gait analysis, fall risk will be measured in younger and older (>60y) subjects     using a triaxial accelerometer.   "
223105|NCT00765310|"     The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to     reduce risk factors such as body weight and high blood cholesterol levels in overweight or     obese participants.   "
223106|NCT00765323|"     Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with     acromegaly that were previously treated with octreotide depot.   "
223117|NCT00765466|"     This is an open label, Phase II, multi-center study designed to evaluate the effect of AVR118     when administered to patients with systemic symptoms related to recurrent or metastatic     cancers who may or may not be undergoing anti-cancer treatment. During the initial, induction     treatment phase of the study, AVR118, 4.0 mL, will be given subcutaneously each day for 28     days. Patients who respond to the trial period dosing will be eligible to continue on AVR118     if they and their physicians believe it would be beneficial, and if no safety concerns are     raised.   "
223118|NCT00765479|"     RATIONALE: Soy protein may help prevent prostate cancer recurrence in patients who have     undergone surgery for prostate cancer.      PURPOSE: This randomized phase II/III trial is studying how well soy protein works and     compares it to a placebo in preventing recurrent cancer in patients who have undergone     surgery for stage II prostate cancer.   "
223119|NCT00765492|"     This is a study to evaluate safety, tolerability, PK and PD effects of orally administered     AZD8529 after multiple ascending doses   "
223107|NCT00765336|"     Researchers want to find out how Minocycline Extended-Release Tablets affect sperm-production     in healthy males.      The study will include Minocycline Extended-Release Tablets, a new once-daily formulation of     minocycline, compared with a placebo or inactive pill.      Approximately 170 healthy adult males will be assigned by chance (like flipping a coin) to 2     treatment groups with approximately 85 subjects per group. You will be treated with either     Minocycline Extended-Release Tablets or placebo once daily. Screening will occur within 14     days prior to the first dose of study drug.      Required study activities include:        -  Written informed consent        -  Weight        -  Two semen collections within 48-72 hours of one another at the screening visit and Days          84,112, 140, and 168        -  Blood draws at the screening visit and Days 84, 112, 140, and 168        -  Genital examination (excluding prostate) at screening and at the Day 84 and Day 112          visits        -  Medical history      You will continue in the treatment phase of the study for 12 weeks.      You will return to the clinic 4 weeks and 8 weeks after completion of the treatment phase of     the study, with the final study visit approximately 12 weeks after the last dose.      Participation will be for 24-weeks.      Up to 10 investigational sites will enroll subjects into the study.   "
223108|NCT00765349|"     REASON FOR STUDY      Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, suitable     measurements of a patient's preoperative cardiorespiratory reserve, performed non-invasively     by cardiopulmonary exercise testing, have been shown to be predictive of outcome following     non-cardiac surgery. Although the exact mechanisms behind poor reserve in this population are     unknown, poor cardiac function and particularly diastolic dysfunction are likely to be     important.      AIMS      The aim of the present study is to investigate the role of diastolic dysfunction in     determining poor cardiorespiratory reserve in elderly patients undergoing major non-cardiac     surgery. This will provide suitable information to inform a further therapeutic preoperative     interventional study.      OBJECTIVES AND METHODS        1. To determine the presence and severity of diastolic dysfunction, measured by          preoperative transthoracic echocardiogram, in a series of elderly surgical patients          undergoing major elective non-cardiac surgery        2. To investigate the relationship between diastolic dysfunction and poor cardiorespiratory          function during and following exercise measured by non-invasive testing including          cardiopulmonary exercise testing, non-invasive blood pressure measurements and          biochemical analysis        3. To determine whether patients with poor diastolic dysfunction are likely to have worse          outcomes following major surgery compared with those who show no evidence of diastolic          dysfunction. Outcomes will be measured in terms of length of hospital stay and early          postoperative morbidity (validated scoring system) and mortality.   "
223109|NCT00765362|"     To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.   "
223110|NCT00765375|"     • To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate     acne vulgaris defined by the Investigator's Global Assessment (IGA)   "
223111|NCT00765388|"     Background Urostomy is a surgical procedure that detours or diverts urine away form a     diseased or defective bladder. The bladder can be removed and the urine is passed out of the     body through an opening (stoma) in the stomach. People with urostomy will not be able to     start and stop urine coming out through the stoma, so a urostomy bag will be fitted to     collect the urine as it comes out.      A urostomy bag consists of an adhesive, which is attached to the skin around the stoma and a     bag connected to the adhesive to collect the urine.      It is very important the standard is high on these products; otherwise the user     (urostomy-patient) will experience lots of problems with the skin around the stoma.   "
223112|NCT00765401|"     Cystic fibrosis (CF) is the most common lethal autosomal recessive disease among Caucasians.     While the pulmonary disease in CF receives most of the attention, gastrointestinal diseases     occur in >95% of CF individuals and can contribute to significant morbidity, mortality and a     decreased quality of life. The abdominal pain in CF is usual chronic in nature, and the     etiology is not usually found, despite medical testing for standard causes of abdominal pain.     Helicobacter pylori (Hp) is increasingly being recognized as the etiology of peptic ulcer     disease and other upper and lower gastrointestinal tract diseases.1 The role that Hp plays in     CF abdominal pain has not been elucidated.      Our long-term goal is to understand relationship between chronic HP infection and abdominal     pain in pediatric CF patients.      The specific objective of this proposal is to utilize current state-of-the-art testing for HP     to determine the prevalence of Hp in our CF patients age 5 and older.      The central hypothesis is that Cystic fibrosis subjects with significant abdominal pain will     have an increased incidence of Helicobacter pylori as determined by the urea breath test and     stool antigen test.      The rationale for the proposed research is that once we elucidate a causal relationship     between CF patients with abdominal pain and Hp, we can begin treatment of this infection to     improve quality of life.   "
223113|NCT00765414|"     This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in a     single patient with infantile-onset Pompe disease who were previously treated with rhGAA in a     Genzyme study.   "
223114|NCT00765427|"     Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety     observation.   "
223115|NCT00765440|"     RATIONALE: It is not yet known which regimen of enteral nutrition is more effective in     preventing infections in patients undergoing surgery for cancer of the upper aerodigestive     tract.      PURPOSE: This randomized phase III trial is comparing three nutrition regimens in treating     patients with cancer of the upper aerodigestive tract.   "
223116|NCT00765453|"     Study hypothesis :      The purpose of this study is to determine whether Intracoronary infusion of autologous bone     marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior     myocardial infarction will lead to an improvement in cardiac function greater than that seen     by placebo alone.      Aims        -  To demonstrate that it is safe and feasible to deliver autologous bone marrow derived          stem cells within hours of the primary angioplasty procedure        -  To demonstrate the effects of autologous bone marrow derived stem cells on cardiac          function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.        -  To demonstrate the effect of autologous bone marrow derived stem cells in addition to          standard care leads to improvement in cardiac function compared to patients          saline(placebo) and standard care.   "
223120|NCT00765505|"     This project will provide novel information concerning the ability of exercise to enhance the     capacity for oxidative metabolism of fatty acids and improve insulin resistance in older     adults who are at high risk for the development of type 2 diabetes. Ultimately this may help     identify mechanisms and therapeutic targets implicated in skeletal muscle metabolic     dysregulation. The proposed study is to conduct a randomized controlled exercise training     intervention trial in older men and women. In addition, the response to exercise in these     subjects will be compared to those of highly endurance-trained, age-matched athletes.   "
223121|NCT00765518|"     This study is designed to assess the safety and tolerability of Cardiac Repair Cells (CRCs)     compared to standard-of-care in patients with dilated cardiomyopathy (DCM).   "
223122|NCT00765531|"     The hypothesis of this study proposal is that pediatric urinary stone formers have genetic     risk factors which predispose their urinary stone production. 50-60% of pediatric stone     patients have a positive family history of urinary stone disease. Several genetic mutations     have been identified which predispose patients to various types of urinary stones. These     genetic mutations can also lead to other significant sequela besides stones, including     osteopenia/osteoporosis (bone loss). Furthermore, metabolic abnormalities can be identified     in more than 50% of pediatric stone formers, some of which can be improved/alleviated with     medical intervention to help decrease rate of stone formation and the need for     hospitalization and surgical intervention.   "
223123|NCT00765544|"     The presence of foot drop limits normal gait. Our prior data has suggested that approximately     30% of MS patients have foot drop. Although we have observed that task-specific     rehabilitation using the Lokomat can improve ambulation in chronic MS patients, subjects with     foot drop have difficulty translating task-specific training to normative gait patterns     over ground, despite improving speed and endurance.      One of the key limitations of the Lokomat is a lack of robot-assisted training for the ankle     joint. The Anklebot, an MIT-developed rehabilitation robot for the ankle, has the potential     to address this. The device can move throughout three planes and train ankle flexion,     extension, inversion and eversion; however, therapy with the Anklebot alone does not train     the knee or hip.      We plan to test whether subject foot drop and overall gait benefit more from Anklebot therapy     alone or a combination of Anklebot and Lokomat.   "
223124|NCT00765557|"     We hypothesize fecal retention is the primary source of bladder dysfunction in some children     with Urge Syndrome. Our specific aims are:        1. To test this hypothesis through a prospective, randomized, double-blinded and          placebo-controlled trial of laxatives for children diagnosed with US.        2. To determine if a validated questionnaire of bowel activity administered to the family,          and when appropriate, the patient, will identify those likely to benefit from laxative          therapy for bladder dysfunction.        3. To determine if the abdominal X-Ray of the kidneys, ureters and bladder (KUB) assessment          of fecal loading corresponds to answers on the questionnaire regarding incidence of          constipation, and/or response to laxative therapy for US.   "
223125|NCT00765570|"     Expand clinical literature on the use of Grid radiation with conventional external beam     therapy. Vast majority of therapy is for palliative care to provide relief from pain, but has     also shown a reduction in the size of tumor mass.   "
223126|NCT00765583|"     A total of 75 subjects will be enrolled into a 36 month study. Subjects will be treated with     Restylane® on both sides of the face (nasolabial folds) at the first visit, on one side of     the face at month 4.5 and on the other side of the face at month 9. Both sides of the face     will then be treated again at month 18. The subjects will evaluate themselves and will also     be evaluated by the treating doctor and a blinded evaluator (a person that does not know when     the different sides of the face are treated). Side effects and medications taken during the     study will also be recorded.   "
223127|NCT00765596|"     The purpose of this study is to determine whether gastric division (via Roux-en-Y gastric     bypass) with resultant fundic isolation will alter the pattern(s) of Ghrelin secretion in the     early post-operative period following feeding in morbidly obese subjects.   "
223128|NCT00765609|"     The Paediatric Analgesia Slide is a device developed for parents. Its development follows     research into the Paediatric Analgesia Wheel, a device intended for use by hospital doctors.     Previous research has shown the benefit of using aids such as the Paediatric Analgesia Wheel     when simulating prescribing to children in hospital.      At present, it is unknown whether this concept can be extended to use by parents when     administering paracetamol to their children at home.   "
223130|NCT00765635|"     Accumulation of cerumen in the external ear canal is a common problem. The presence of     cerumen not only interferes with the clinician's view of the tympanic membrane, but may also     result in hearing loss and vertigo, and may predispose to ear infections.      Removal of cerumen is facilitated by the use of a variety of ceruminolytics, or wax solvents.     The current study was designed to evaluate the ceruminolytic effects of a single, brief     application of the two most frequently used products in the investigators area, containing     chlorobutanol or potassium carbonate with or without irrigation in the primary care setting     in a randomized, single-blind trial. To our knowledge, this is the first randomized study     comparing ceruminolytics with chlorobutanol versus potassium carbonate.   "
223131|NCT00765648|"     The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol     administered intravenously for the management of hypertension in the emergency department     setting.   "
223132|NCT00765661|"     The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of     medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf®     capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a     transplanted kidney. LCP-Tacro is a tablet containing the same active ingredient (tacrolimus)     that is in Prograf capsules, but the tablet has been designed to release tacrolimus over an     extended period so that it only has to be taken once daily. LCP-Tacro is an investigational     drug.      This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a     kidney transplant in patients randomly assigned (by chance, like flipping a coin) to take     either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In     addition, patients will remain on study drug for 360 days in order to evaluate the relative     safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.   "
223136|NCT00765713|"     Hypothesis:      The CPAP treatment diminishes the effect of ventricular arrhythmias in patients with ischemic     heart disease or dilated myocardiopathy, systolic ventricular disfunction and sleep     apnea-hypopnea syndrome (SAHS)Objectives: To analyze the incidence of ventricular arrhythmias     (premature ventricular beat, non-sustained ventricular tachycardia and sustained ventricular     tachycardia) and appropriate defibrillator therapies in patients with ischemic heart disease     or dilated myocardiopathy, moderate-severe left ventricular dysfunction,with an implantable     cardioverter-defibrillator (ICD) and sleep apnea. To study the effect of CPAP on the cardiac     arrhythmias and on the number of appropriate defibrillator therapies.      Design:      Parallel, randomized and single-blinded multicentric study to compare CPAP vs.     hygienic-dietetic recommendations.      Patients with SAHS (AHI≥15) and systolic left ventricle dysfunction patients with an ICD.      Duration: 24 months.   "
223137|NCT00765726|"     The purpose of this study is to collect safety information associated with the use of Xyntha     in a usual care setting. Upon meeting eligibility criteria, patients will be required to have     approximately 5 study visits over a 2 year period. Procedures completed throughout the study     include collection of vital signs, physical exams, and laboratory assessments. Patients will     be required to complete an infusion log for each Xyntha infusion.   "
223138|NCT00765739|"     The purpose of this project is to test the effectiveness of neuromuscular electrical     stimulation (NMES) that produces 40 % of maximum voluntary contraction (MVC) in increasing     muscle size and improvement in muscle force output within the thigh muscle of elderly people.   "
223139|NCT00765752|"     Disturbances in the amino acid neurotransmitter (AANt), gamma-amino butyric acid (GABA)     function are hypothesized to contribute to the neurobiology of Major Depressive Disorder     (MDD) and insomnia. The principal objective of this project is to use magnetic resonance     spectroscopy (MRS) to provide the first in vivo characterization of cortical GABA levels in     individuals with primary insomnia, and to determine whether subjects with MDD, achieving a     partial response with selective serotonin reuptake inhibitor treatment but still experiencing     significant residual symptoms including insomnia, have altered levels of this     neurotransmitter. The investigators are also exploring the correlation between cortical AANt     levels and abnormalities in sleep parameters in primary insomnia and as a residual symptom of     major depression.   "
223140|NCT00765765|"     RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Hydroxychloroquine may help ixabepilone work better by making tumor cells more sensitive to     the drug.      PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone     given together with hydroxychloroquine and to see how well they work in treating patients     with metastatic breast cancer.   "
223141|NCT00765778|"     Detailed activity:        -  Family members and caregivers of carrier residents will be screened for ESBL and MRSA.          Screening will be performed by obtaining nares and perirectal cultures. Nares cultures          will be obtained by ward staff or research personnel who are experienced in performing          this activity: a moisture swab will be applied gently to the distal part of both nares.          Perirectal cultures, will be taken by swab, who will be applied to the perirectal area,          either by staff as mentioned above, or will be given to the participants to perform by          himself (with explanation on how to perform it).        -  The Family and Caregiver Screening Form will be filled out; results of screening will be          added to the forms. This data will be stored after removal of all Family members'          identifiers for further analysis.        -  In order to allow follow up, a list linking between the Family members' study number and          his identifying details will be kept separately in the rehabilitation center. This list          will not be transferred elsewhere.   "
227615|NCT00825396|"     The purpose of this study is to determine the safety and tolerability of topical C-KAD     Ophthalmic Solution in reducing intraocular pressure in patients with ocular hypertension.   "
223142|NCT00765791|"     Many types of head and neck cancers will have local spread to the neck. As such selective     neck dissection is performed as part of the treatment. The neck is divided into various     levels. Selective neck dissection targets areas that are most likely to harbor cancer cells     for specific types of head and neck cancers. Level IIB has been particularly controversial in     the last few years, as the rate of cancer spread to this area has been shown to be quite low     (0-8%). Moreover, because the spinal accessory nerve (involved in shoulder function) runs     through this area, there is theoretical risk of causing post-operative shoulder weakness. As     such, the question of whether removing level IIB, knowing that there is low chance of it     containing disease spread, is worth risking decreased shoulder function. Some would argue     that all potential diseased sites should be removed at all costs. While other advocate that a     balance between disease cure and function should be maintained. However, what needs to be     determined is just what impact does dissecting IIB have on shoulder function. At our     institution, the rate of poor shoulder function associated with selective neck dissection has     been perceived as being quite low. This study is designed to test this observation.      Hypothesis: Neck dissection including level IIb in head and neck cancer patients will not     lead to worse shoulder function and quality of life than when level IIb is preserved.   "
223143|NCT00765804|"     The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of     dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in     patients with dry eye.   "
223144|NCT00765817|"     This study will compare the efficacy and safety of exenatide versus placebo in adults whose     diabetes is not fully controlled by insulin glargine with or without metformin and/or     pioglitazone.   "
223145|NCT00765830|"     This clinical trial is designed to provide additional information on the safety and     tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2     diabetes mellitus (T2DM) and moderate or severe renal insufficiency   "
223146|NCT00765843|"     This is a study investigating treatment of plantar fasciitis (heel pain). Physicians commonly     prescribe specialized orthoses (shoe inserts) to treat heel pain. This study will evaluate     the reduction in heel pain associated with three types of orthoses. It is hypothesized that     custom made orthoses will significantly decrease pain and improve foot function in comparison     to prefabricated insoles and sham insoles.   "
223147|NCT00765856|"     Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the     Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every     12 hours. Dosing adjustments will be based on the review of the subject's pain scores.     Oxymorphone IR 5 mg will be provided to be used as supplemental breakthrough pain     medication (as needed). Titration Period will end when the fixed dose of study medication is     tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the     open-label 3-month maintenance period on the fixed dose of study medication established     during the Titration Period.   "
223148|NCT00765869|"     The purpose of this study is to evaluate a decision aid (written information booklet designed     to facilitate informed decision making) to help people aged 55-64 years, with low levels of     education and literacy, make an informed choice about bowel cancer screening, using faecal     occult blood testing.   "
223149|NCT00765882|"     The objective of this trial is to determine the efficacy and safety of linaclotide     administered to patients with chronic constipation (CC). The primary efficacy parameter is     the percentage of patients in each treatment group that meet the protocol definition for     Complete Spontaneous Bowel Movement (CSBM) Overall Responder   "
223150|NCT00765895|"     The principal objective of this multicenter, randomized, placebo-controlled trial is to     evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared     with placebo.   "
223151|NCT00765908|"     This study aims to assess the potential for ischaemic peri-conditioning (IP) in elective     percutaneous coronary intervention (PCI) patients to attenuate ischaemia in an animal model     of myocardial infarct.   "
223152|NCT00765921|"     The purpose of the study is to investigate the safety and tolerability of the anti-VEGF     (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton     beam irradiation for the treatment of choroidal melanoma by determining the incidence and     severity of ocular adverse events. Systemic adverse events will also be evaluated. A     secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications     that can occur after irradiation.   "
223153|NCT00765934|"     There is an increasing awareness of the importance of treating procedure-related pain.     Patients undergoing vascular access procedures are often afraid of needles and the discomfort     associated with injections. This type of pain and/or fear can be stressful to patients. [1]     For prevention of the pain associated with these procedures, the hospital is using Rapydan     plasters. Rapydan consists out of two local anesthetics: lidocaine and tetracaïne. Rapydan     produces topical anesthesia after an application time of 30 minutes and is used in the     Martini Hospital for pain relieve by venipuncture and IV cannulation. The venous blood     draining the anaesthetized skin contains a higher blood concentration of the local     anesthetics than does venous blood in other parts of the body [2] Although the concentrations     of the local anesthetics are low in patients with normal skin, the question is whether the     presence of the local anesthetics which Rapydan contains might influence routine measurements     in clinical chemistry and hematology.   "
223154|NCT00765947|"     This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood     pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting     Systolic Blood Pressure [msSBP] ≥ 140 mmHg and < 180 mmHg and/or mean sitting Diastolic Blood     Pressure [msDBP] ≥ 90 and <110 mmHg).   "
223155|NCT00765960|"     The purpose of this study is to assess the efficacy, predictability and safety of the     Advanced CustomVue™ iLASIK procedure (WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser     System and IntraLase™ FS System).   "
223175|NCT00766220|"     The goal of this clinical research study is to find out what effects radioactive particles,     SIR-spheres, have when injected into the liver, followed by systemic chemotherapy with a     combination of cetuximab and irinotecan compared to those who have systemic therapy alone, in     patients with colon cancer that has metastasized to the liver. The safety of this treatment     and how well it controls the disease will also be studied.   "
223156|NCT00765973|"     A multi-center, open-label, two-arm, dose-escalation study to establish the safety,     tolerability, MTD, and schedule of TLI administered intravenously as a 30 minute infusion in     adult subjects with advanced solid tumors that have relapsed, are refractory to standard     therapy, or for whom there is no standard therapy available.      The two dosing regimens to be evaluated are:        -  Arm A: TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)        -  Arm B: TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)      When one of the two arms reaches MTD, all future subjects will then be enrolled in the     remaining study arm until MTD of that arm is reached.   "
223157|NCT00765986|"     Non-small cell lung cancer (NSCLC) has a poor prognosis if not caught early enough. One of     the factors that may impact the ability to control NSCLC is low oxygen levels (hypoxia)     inside the tumour. This study will use 18F-FAZA PET scans to assess whether patients have     hypoxic tumours and to monitor the changes to the hypoxic areas of a tumour during currently     available standard treatment. It is hypothesized that 18F-FAZA PET may predict response to     treatment, local control, and/or survival in NSCLC.   "
223158|NCT00765999|"     The objective of this study is to assess the long-term safety of linaclotide administered to     patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C)   "
223159|NCT00766012|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive     multiple-ascending panels are planned. Subjects will start with an initial single dose that     is followed by a wash-out period of 48 hours to adequately define the single-dose     pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended     to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once     daily for 10 days. Ten (10) subjects will be allocated to each dose panel and randomized to     receive either AZD2066 or placebo.   "
223160|NCT00766025|"     The main purpose of this study is to examine Taiwanese subjects identified as CYP2C19 poor     and extensive metabolizers while taking single and multiple dosing a rosuvastatin calcium.   "
223192|NCT00766454|"     RATIONALE: Studying samples of urine and blood from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This study is looking at urine and blood samples in women with newly diagnosed     breast cancer.   "
223161|NCT00766038|"     Growth Hormone (GH) deficiency, defined by insufficient GH response to a variety of     stimulating compounds, is found in 20-35% of adults who suffer traumatic brain injuries (TBI)     requiring inpatient rehabilitation1. However, there is no accepted gold standard for     diagnosing GH deficiency in this population. Further, the major effector molecule of the     somatotropic axis, Insulin-Like Growth Factor-1 (IGF-1) has recently been recognized as an     important neurotrophic agent. Since most repair and regeneration after TBI occurs within the     first few months after injury, absolute or relative deficiencies of GH and IGF-1 in the     subacute period after TBI are potentially important factors why some patients fail to make a     good functional recovery. The proposed study is a randomized, double-blind,     placebo-controlled trial of rhGH, starting at 1 month post TBI, continuing for 6 months.      This study has one primary hypothesis, that treatment with recombinant human Growth Hormone     (rhGH) in the subacute period after TBI results in improved functional outcome 6 months after     injury. As secondary hypotheses, we will investigate what is the optimal method to diagnose     GH deficiency in TBI survivors and study the relationship between GH deficiency and     insufficiency and functional recovery.   "
223162|NCT00766051|"     Many critically ill newborns in the neonatal intensive care (NICU) or critical care unit     (NCCU) environment develop feeding and movement problems. The purpose of this study was to     determine the extent to which neurophysiologically based occupational therapy intervention     (NBOTI) for NCCU infants would affect the intervention group's oral feeding and other     covariates, such as heart rate variability (HRV) during feeding. The biopsychosocial model     provided the study's conceptual framework. The key research question explored whether NBOTI     in the NCCU promoted healthy infant development through feeding, movement organization, and     parent self-efficacy. This exploratory study with 10 NCCU infants and 10 historical matched     controls utilized a mixed method design of qualitatively coded video analysis and inferential     statistics such as the t test, the binomial test, hierarchal linear modeling (HLM), and     multivariate analysis. Significant differences were obtained between the intervention and     comparison groups in the number of days from all tube to all oral feeding before discharge     and speed at which the infants gained weight. Longitudinal analyses of the intervention group     data were employed to reveal significant trends and pre/post differences in the HRV data     along with how quickly the infants ate, parent perceptions of self efficacy and decreased     stress in the NCCU. Finally, qualitative findings obtained from videotape analysis provide     further evidence that NBOTI was effective in facilitating feeding and promoting development.     The recommendations are to replicate this study to validate and expand the findings of the     current study. The model for infant care suggested by the findings could contribute to     positive social change by fostering positive physical and emotional child development and     healthy child-parent and family-caregiver relationships.   "
223163|NCT00766064|"     Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment     response to pharmacological interventions has been modest for these patients. Chronic     elevated anxiety and associated psychophysiological parameters including increased heart rate     and alterations in skin conductance are key symptoms of chronic PTSD. Antidepressants,     including selective serotonin reuptake inhibitors (SRIs) or norepinephrine-serotonin     re-uptake inhibitors are considered treatment of first choice for these patients, however a     substantial portion of patients do not respond sufficiently (Zhang and Davidson 2007).     Therefore, there is a need to establish novel and effective add-on treatment strategies for     these patients. Recently, atypical neuroleptics have received considerable attention since it     was shown in multiple controlled and naturalistic trials that these medications are an     effective treatment option for patients with PTSD (Davis et al 2006). In chronic PTSD, the     psychophysiological responses at baseline and in response to treatment have yet been     inadequately studied and may provide novel insight into antidepressant and anxiolytic     mechanisms of medications used in the treatment of PTSD. Therefore, in addition to evaluating     the antidepressant and anxiolytic effects of paliperidone, a novel atypical neuroleptic, in     the treatment of PTSD, we also aim to compare neurophysiological responses at baseline with     post-treatment effects in antidepressant-refractory PTSD patients.      Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of paliperidone in patients     with PTSD.      Secondary Aim 2: Evaluate the effects of paliperidone on fear conditioned psychophysiological     responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat     interval) at baseline and after 6 weeks of naturalistic treatment in chronic PTSD patients.   "
223174|NCT00766207|"     This study will use a factorial design randomized controlled trial to (1)compare     multi-faceted decision support (intervention) to streamlined clinical alerts (control) and     (2) evaluate whether collecting information about women's risk of pregnancy using a networked     tablet computer (intervention) is superior to the way clinicians usually collect this     information (control).      Over the course of 1 year, we will abstract data from the electronic medical record when     study clinicians prescribe teratogenic medications, conduct phone interviews with women     prescribed medications by participating clinicians, and survey participating clinicians about     their satisfaction with the decision support they receive. We will use this data to confirm     our hypotheses that clinicians in the intervention groups will (1) prescribe fewer     teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic     medication is prescribed, (3) have more patients report satisfaction with the counseling they     received, and (4) report more satisfaction with the decision support they received.   "
223164|NCT00766077|"     Stress fractures are a common and debilitating injury for a variety of athletes however     current evidence does not clearly allow easy prediction of athletes at risk for a first     fracture. Animal and some preliminary human evidence suggest that assessment of bone     strength, muscle size and running mechanics may be primary risk factors for stress fractures.     The investigators study will help determine which, if any, of these modifiable risk factors     could help identify athletes at risk for stress fracture.      Competitive female distance runners will be recruited for this study. Participants will     placed into a stress fracture or control group based on stress fracture history. Dual energy     x-ray absorptiometry (DXA) and peripheral Quantitative Computed Tomography (pQCT) will be     used to assess bone structure and strength. Running mechanics will be assessed during a 30-40     minute fatiguing run. A treadmill with an embedded force plate and high speed video will be     used to assess changes in running mechanics throughout the run.      The purpose of this project will be to        1. explore differences in volumetric bone mineral density (vBMD), bone geometry, and muscle          cross sectional area (MCSA) using pQCT        2. explore changes in load (GRFs) and running mechanics that occur during a fatiguing run          in runners with and without a history of stress fracture.   "
223165|NCT00766090|"     The purpose of this study is to compare once and twice daily GW685698 in asthma   "
223178|NCT00766259|"     Inpatients will be prospectively have nares screened and MRSA strains collected. All clinical     MRSA strains of patients will also be prospectively collected. A sensitive strain     discrimination test of spa typing will be used to determine if the strains are related.     Hypotheses are        1. Strain colonization durations vary and may be very short in days to weeks.        2. Colonizing strains rarely infect 3) Both 1 and 2 may be affected by the patient's          co-morbidity.   "
223193|NCT00766467|"     The purpose of this research study is to determine if armodafinil is safe and effective in     treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy     plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the     treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also     help to reduce radiation-induced fatigue in brain tumor patients.   "
223166|NCT00766103|"     Incidence of hypo- and hypercarbia during induced hypothermia after cardiac arrest is high.     The original report from HACA-group reported that hypothermia treated patients had improved     survival and neurological outcome. Suprisingly, in that trial normocarbia was not achieved     even though the aim was set for ventilatory support as normoventilation. This study aims to     investigate the effects of mild hypo- and hypercarbia on cerebral perfusion (blood flow,     intracranial pressure) and metabolism (microdialysate metabolites). We hypothesize that     uncontrolled ventilatory suppport may render the patients in risk of exacerbation of neuronal     damage, conversely, further improvement in outcome may be achieved with succesfull     ventilatory management. We intend to enroll 10 out-of-hospital cardiac arrest patients     succesfully resuscitated and subsequently treated with controlled hypothermia for 24 hours.     The patients in need of anticoagulation are excluded. We plan to induce mild hypocarbia and     hypercarbia during and after induced hypothermia. Metabolic and perfusion data are collected     with clinically used methods such as transcranial doppler, intracranial pressure measurement,     near infrared spectroscopy, jugular bulb, intracerebral microdialysis).   "
223167|NCT00766116|"     This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in     the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that     has come back after treatment.   "
223168|NCT00766129|"     Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary     arteries. There are several kinds of DES i.e. eluting the drug either from stable or     biodegradable polymer. The type of the polymer may impact the clinical outcome. The aim of     our study was to compare safety and efficacy of implantation of two different types of stents     eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent)     into coronary artery by-pass graft.   "
223169|NCT00766142|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Giving more than     one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well chemotherapy given together with cetuximab     works in treating patients undergoing surgery to remove peritoneal carcinomatosis from     colorectal cancer.   "
223170|NCT00766155|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of     radiation directly on the tumor may kill more tumor cells and have fewer side effects. Giving     chemotherapy together with radiation therapy before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after     surgery may kill any tumor cells that remain after surgery. It is not yet known whether     capecitabine is more effective with or without oxaliplatin in treating patients with rectal     cancer.      PURPOSE: This randomized phase III trial is studying giving chemotherapy together with     radiation therapy before surgery followed by capecitabine with or without oxaliplatin to see     how well it works in treating patients with locally advanced rectal cancer.   "
223171|NCT00766168|"     The purpose of this study is to establish the substantial equivalence of the HDS HI 1.54™ to     the paflufocon C material control lenses to correct myopia and hyperopia with and without     astigmatism. The purpose of the study is to profile the outcome endpoints and the patient     acceptance of this Class II medical device.   "
223172|NCT00766181|"     The purpose of this study is to determine the satisfaction among parents and nurses of     pediatric patients with IV catheter placement in the Emergency Department.   "
223173|NCT00766194|"     This study will measure nasopharyngeal pressure in neonates using a miniature high resolution     catheter-tip pressure transducer. Any neonatal intensive care patient being treated with     nasal respiratory support (e.g., nasal continuous positive airway pressure, nasal cannula     flow either high (>1 LPM) or low (<1 LPM), and nasal prong ventilation either intermittent     mandatory or high-frequency) will be eligible for study. The catheter-tip transducer will be     placed within a standard gavage feeding tube catheter and introduced through the mouth into     the posterior nasopharynx where continuous measurements will be made over 15 minutes. The 15     minute recording will be divided into 5 three minute segments, including a baseline recording     at the ordered settings of pressure or flow, a recording at 1 level above baseline, a     recording back at baseline, a recording 1 level below baseline, and a final segment back at     baseline. The order of increase-decrease or decrease-increase from baseline will be by random     sequence. Measurements may be repeated with any change in nasal gas flow or pressure ordered     for patient care. These measurements will be used to correlate the ordered nasal respiratory     support therapy with the actual upper airway pressure created by the therapy.   "
223176|NCT00766233|"     Hyperthermia - a warming of the tumor at 42-43 ° C - in combination with radiation and / or     chemotherapy is a proven method of treatment for malignant tumors. The amplification of the     effect of radiotherapy and various chemotherapeutic agents (platinum analogues, nitrogen-Lost     derivatives, cytotoxic antibiotics) is experimentally demonstrated. Randomized clinical     trials have shown a better chance of survival and better local tumor control without     increasing the toxicity of combined treatment especially also in children's tumors. The     combination of hyperthermia and radiation therapy is more effective than radiotherapy alone.     Hyperthermal temperatures increase blood circulation in tumors as a response to stimulation     with heat. Tumor tissue, having a minor circulation and being acidotic, is resistant to     radiotherapy, but sensitive to hyperthermia, while tumor with a high blood flow is     sensitivity to radiation. This positive interaction is a compelling reason for the     combination of hyperthermia and ionized radiation.      Hyperthermia, in combination with chemotherapy, increases the concentration of cytostatics in     the tumor region, raising blood flow caused by warmth. In addition, hyperthermia increases     toxicity of drugs in cells, being normally resistant to many drugs. Hyperthermia can     synergistically be combined with chemotherapy treating high risk - tumors with curative     intention.      In addition to the clinical use of surface hyperthermia (BSD 500 - O), with appropriate     treatment of tumors up to 3 cm deep from the surface of the body with established indications     and palliative indication in advanced stages of cancer, a prospective, randomized study with     quality-controlled thermometry shall establish the optimal sequence of Hyperthermia in     combination with irradiation. Therefore the treatment sequence of once per weeks is compared     to a sequence of three times per week.   "
223177|NCT00766246|"     This is a randomized, open-label, multicenter study in 160 patients in first line treatment     and 114 in second line treatment with advanced or metastatic NSCLC (Stage IIIB/IV).   "
224215|NCT00780182|"     The purpose of this study is to compare the bioavailability of CMX001 when administered as a     tablet vs a solution and to determine the effect of a high-fat meal on CMX001     bioavailability.   "
223179|NCT00766272|"     Multiple sclerosis is a degenerative disease that affects more than 400,000 people in the US     alone. MS is in fact the most common disabling neurological disorder in young adults.     Symptoms of the disease can include problems with balance, walking, fatigue, weakness and     vision. Over 85% of people with Multiple Sclerosis have problems walking. This can cause them     to fall or have a constant fear of falling. To prevent falling, MS patients rely on     equipment, such as walkers and canes. These costs can cause financial difficulties for MS     patients and families.      A significant problem that is only recently being studied is the relationship between falling     and MS. Recent studies have shown that MS patients fall more often than those without MS, and     also fall more than the elderly population. The consequent fear of falling is also an     important problem, as those worried about falling will probably change their daily habits to     lower their risk. This can mean keeping from certain physical and social activities or even     staying indoors. Thus, falls and fear of falling can have negative medical, physical,     psychological, and social consequences for the patient.      Improving patients' walking may help reduce falls and the fear of falling. Treadmill training     has been shown to improve walking in patients with MS and to lower their risk of falling. One     way to train patients on a treadmill is with the use of robots that can help move their limbs     in a more normal way. This kind of robot-assisted treadmill training may provide even greater     benefits than treadmill training alone.      The study is expected to last 6-7.5 months. One group of participants will receive weekly     telephone calls and will be asked questions on other physical activities, falls, and activity     limitations the patient had during the week. Participants assigned to robot-assisted     treadmill training will receive twice weekly training session for 8 weeks, for a total of 16     sessions. Each session will last about 65 to 90 minutes.      The goal of this study is to see if robot-assisted treadmill training will reduce falls and     fear of falling in patients with MS. Robot-assisted treadmill training has been shown to be     effective in reducing falls and fear of falling in Parkinson's disease patients. This type of     training has not been tested in patients with Multiple Sclerosis. The proposed study will     help to address this gap and also provide additional data on other possible improvements due     to robot-assisted treadmill training including ambulation, social participation, fatigue, and     balance.   "
223180|NCT00766285|"     Influenza is a common infection of the upper airways and lungs, and is caused by viruses.     Cancer patients may need a stronger influenza vaccine than the general population to protect     against influenza. The experimental vaccine is designed to be 9 times stronger than the     standard vaccine, which may cause a stronger immune response against influenza in patients     with a weakened immune system. The goal of this study is to compare the effects of a new     experimental influenza vaccine to the effects of the standard influenza vaccine. One hundred     bone marrow recipients, adult volunteers from the MD Anderson Cancer Center, 18 years of age     or older, will participate in this study. They will be randomly (by chance) assigned to     receive 2 doses of either the standard licensed influenza vaccine or the experimental     influenza vaccine. Participants will be asked to complete 5 study visits and 3 telephone     contacts. Study procedures include blood draws. The duration of participation is about 6     months.   "
223181|NCT00766298|"     102 late- life adults at risk for developing type 2 diabetes mellitus, will be randomized to     one of three interventions designed to improve insulin sensitivity thereby potentially     preventing future progression of type 2 diabetes. The investigators predict that insulin     sensitivity will improve equally following either weight loss or exercise, while there will     be additive effects from combined intervention.      The investigators hypothesize that weight loss will decrease intermuscular adipose tissue,     intramyocellular lipid, and visceral abdominal adipose tissue.   "
223182|NCT00766311|"     Survivors of childhood leukemia have muscle weakness and impaired mobility (physical     performance), a higher than expected frequency of obesity, and early mortality from     cardiovascular disease. Treatment related neuropathy, cardiotoxicity and general cachexia may     complicate physical performance and establish a pattern of sedentary behavior that may lead     to a lifetime of inactivity. There is limited evidence that children being treated for     leukemia benefit from home exercise programs during the maintenance phase of therapy,     particularly in terms of muscle strength and range of motion. However, there are no     established guidelines regarding the prescription of exercise for children diagnosed with     leukemia. We propose to test the feasibility of an exercise intervention among children being     treated for acute lymphoblastic leukemia (ALL) and hypothesize that children who participate     in the exercise intervention will demonstrate improvements in gross motor function, strength,     flexibility, and cardio respiratory fitness, and that they will have more favorable body     composition when compared to the children who are assigned to the usual activity group.   "
223183|NCT00766324|"     To assess the antitumor activity of PHA-739358 administered as IV infusion according to two     different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based     1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule     for further investigation.   "
223184|NCT00766337|"     The purpose of this study is to determine the safety and efficacy of an ocular sirolimus     (rapamycin) formulation in combination with Lucentis in patients with sub-foveal choroidal     neovascularization secondary to age-related macular degeneration.   "
223185|NCT00766350|"     Quetiapine, a second generation antipsychotic, has shown beneficial activity on fibromyalgia     symptomatology, administered as add-on treatment, in a sample of 35 patients. The purpose of     the present study is to compare, in a controlled setting, the efficacy and the tolerability     of quetiapine extended release with amitriptyline in the treatment of patients with     fibromyalgia   "
223186|NCT00766363|"     This study is being conducted to determine the safety, tolerability, and pharmacokinetics     (PK) of three different doses of an investigational medication, EVP-6124, in individuals with     mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI     [acetylcholinesterase inhibitor]: either donepezil or rivastigmine). In addition, PK of AChEI     medications will be assessed. Cognitive function will be evaluated on an exploratory basis.   "
223187|NCT00766376|"     The purpose of this research study is to evaluate the safety and effectiveness of erbium     lasers for dermatological cosmetic procedures.   "
223188|NCT00766389|"     The Cirrus HD OCT, a new spectral domain optical coherence tomography (OCT), has better     resolution than the previous time domain Stratus OCT. Discriminating ability of these two     OCTs for diagnosis of glaucoma and judgement of disease progression will be studied.   "
223189|NCT00766402|"     The purpose of the study is to investigate the clinical benefit of tramadol/acetaminophen     versus non-steroidal anti-inflammatory drugs (NSAID) (diclofenac 50 milligram [mg]) in the     treatment of pain in participants with ankylosing spondylitis (inflammation of the spine     causing pain and stiffness) receiving stable treatment of disease modifying anti-rheumatic     drugs (DMARDs).   "
223190|NCT00766415|"     The purpose of this study is to study histological changes, cellularity, clinical efficacy     and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease   "
223191|NCT00766441|"     This study will assess if Sitagliptin addition to metformin or glitazone is better than     current sulphonylurea based treatments during Ramadan. The rationale is that Sitagliptin     offers metabolic advantages primarily with the low incidence of hypoglycemia over current     sulphonylurea based treatments.   "
223194|NCT00766480|"     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This clinical trial is studying tissue samples in predicting how well chemotherapy     and radiation therapy will kill cancer cells in patients with squamous cell carcinoma of the     esophagus.   "
223195|NCT00766493|"     Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with     FDA-approved carotid stents to a performance goal obtained from carotid stent studies     utilizing distal embolic protection.   "
223196|NCT00766506|"     The purpose of this study is to evaluate the mobilization characteristics, clinical use,     safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled     Analgesia (PCA) system (Ionsys) and morphine intravenous (IV) PCA for management of moderate     (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in     participants who have undergone elective major abdominal or orthopedic (pertaining to the     bones) surgery.   "
223197|NCT00766519|"     The purpose of this study is to determine whether intraoperative goal-directed fluid     management (with goal = cardiac stroke volume maximization) based on respiratory-induced     pulse pressure variation monitoring may improve outcome after intrabdominal surgery   "
223198|NCT00766532|"     Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption?      Study Design: Postmenopausal women with early stage breast cancer initiating aromatase     inhibitor adjuvant therapy will participate in this two-month study. The primary study     outcome is the change in intestinal calcium absorption following such therapy. Secondary     outcomes are the changes in bone resorption markers and musculoskeletal signs and symptoms     after initiation of therapy.      We will interview women and review their medical records to determine eligibility. Eligible     subjects will undergo two calcium absorption studies. The first study will determine their     baseline calcium absorption, and the second study will occur after taking an aromatase     inhibitor daily for at least 6 weeks. Women will present to the research unit in the early     morning and receive an oral and intravenous stable calcium tracer with breakfast. Over the     next 24 hours, we will collect all urine for measurement of its calcium content. During each     inpatient stay, we will assess musculoskeletal symptoms by questionnaire and joint     examination. Each woman will complete a four-day diet diary twice during the study.   "
223199|NCT00766545|"     The multi-center, double-blind, placebo-controlled, randomized, group-comparison study was     designated to assess the long-term safety and efficacy of the antiplatelet drug cilostazol in     preventing the recurrence of cerebral infarction in patients who had suffered a cerebral     infarction 1 to 6 months prior to entering the trial.   "
223200|NCT00766558|"     A technique that has been found to be effective at relieving the physical and psychological     symptoms associated with inhibiting emotions and emotional thoughts is written emotional     disclosure. The goal of this study is to evaluate the effectiveness of written emotional     disclosure on the remediation of eating disorder behaviour, cognitions, and management of     emotions.   "
223211|NCT00766714|"     A prospective randomized trial comparing Cook K-SOFT-5100 and Frydman classical catheter 4.5     for embryo transfer in human IVF/ICSI was performed. Three experienced operators participated     in the trial, using a fixed distance transfer protocol. Primary endpoint was clinical     pregnancy rate, secondary endpoints were rates of difficult transfer and of catheter failure.     Patients were randomized by a computer program immediately prior to embryo transfer.   "
223257|NCT00773019|"     This FDA Condition of Approval study will include up to 100 subjects at up to 13 US centers.     Subjects are selected from those evaluated and planning to receive a SynchroMed II drug     infusion system for treatment of severe spasticity or chronic pain. Subjects must return for     refill visits at 1, 6, and 12 months. In addition, subjects return for any other medically     necessary refills. Information is collected on all refills and adverse events.   "
223201|NCT00766571|"     This study will explore the medical problems in patients with VACTERL association and     identify gene changes that might be responsible for them. VACTERL association can affect many     parts of the body, including the bones of the spine, the heart, the lower intestinal tract,     the connection between the trachea and esophagus, the kidneys and the arms. Information from     this study may lead to a better understanding of the disease and improved treatment and     genetic counseling.      Patients with VACTERL association and their parents and siblings may be eligible for this     study.      Patients are admitted to the NIH Clinical Center for evaluation over 3 to 4 days that may     include the following procedures:        -  Physical examination, medical history, electrocardiogram (EKG), blood and urine tests        -  Eye examination        -  Imaging studies (echocardiogram, x-rays and ultrasound tests)        -  Other specialized tests or consultations as indicated        -  Optional medical photographs of the face and other body parts that may be involved in          VACTERL association for publication in scientific texts or for teaching purposes        -  Optional return visit after 2 years for repeat testing and to look for changes over time      Parents of patients have the following procedures:        -  Physical examination, medical history, blood tests and x-rays, if needed        -  Specialty consultations as indicated        -  Optional medical photographs of the face and other body parts that may be involved in          VACTERL association for publication in scientific texts or for teaching purposes        -  Questionnaires about their child s medical history, growth, behavior and development,          therapy and medication      Siblings of patients have the following procedures:        -  Physical examination, medical history and blood tests   "
223202|NCT00766584|"     The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which     permanently feed information back to this global biological vigilance system controlling     allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one     of the best indicators of ANS activity.      Low ANS activity level is associated with severe cardiac and cerebral events, as well as to     death from any cause in the general population. It is even associated with sleep     apnea/hypopnea.   "
223203|NCT00766597|"     Complications with current HIV antiretroviral therapy have left many children and adolescents     with limited therapeutic options due to drug resistance. The purpose of this study is to test     the effectiveness and safety of Vicriviroc (VCV), an HIV entry inhibitor and CCR5 co-receptor     antagonist.   "
223204|NCT00766623|"     The primary aim of this study is to evaluate the effect of a high fat challenge on several     measures of endothelial function. The secondary aim of this study is to elucidate the     mechanism of postprandial endothelial dysfunction and to identify early biomarkers   "
223205|NCT00766636|"     Primary Objective:      To assess margin positive resection rate (R1 resection rate; defined as tumor within 2 mm of     surgical margin on final pathology report) in patients treated with preoperative     chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy     followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head.      Secondary Objectives:        -  To assess disease free survival        -  To assess overall survival        -  To assess patterns of local and distant failure   "
223206|NCT00766649|"     This study will determine if a drug called sirolimus is safe to give to people with     geographic atrophy GA and if it can help preserve vision in patients. GA is an advanced form     of dry age-related macular degeneration (AMD). AMD affects the macula, the central part of     the retina needed for sharp, clear vision. There are two types of AMD, wet and dry. In dry     AMD, cells in the macula die.GA may at least partly be caused by inflammation. Sirolimus     helps prevent inflammation and therefore may help treat GA.      People with GA in both eyes with visual acuity between 20/20 and 20/400 in each eye may be     eligible for this study. Participants undergo the following tests and procedures:        -  Sirolimus injections in the study eye at each 3-month clinic visit. The drug is injected          under the outer layer of the eye after the patient receives antiseptic and numbing          drops. Antibiotic drops are continued for 2 days after the injection.        -  Eye examinations before the first injection, 1 month after the first injection, during          each clinic visit (11 to 15 visits over 2 to 3 years) and 3 months after the final          injection. The examination includes testing visual acuity, measuring eye pressure and          checking eye movements. To examine the inside of the eye, the pupil is dilated with eye          drops. Regular photographs of the inside of the eye and optical coherence tomography          photographs, which allow measurement of the thickness of the retina, may be taken during          the eye examination.        -  Autofluorescence imaging. The patient sits in a chair with his or her head placed in a          chin rest in front of a camera. A light in the camera is used to scan the eye.        -  Blood tests. Blood is drawn at the first visit and at up to seven study visits to check          blood chemistries, such as liver and kidney function.        -  Urine pregnancy test for women who are able to become pregnant.   "
223207|NCT00766662|"     Studies have shown that Intermittent preventive treatment in infants (IPTi) with     Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without     modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential     public health tool of great benefit to the children of Africa and a logical addition to the     Immunization Plus package. The objectives of this operational researcher were        -  to develop an implementation model for IPTi in the health care system in Mali        -  to assess its impact on the EPI vaccines and other health interventions coverage        -  and on molecular makers of resistance to SP   "
223208|NCT00766675|"     The purpose of this study is to evaluate the analgesic effect of combination of tramadol     hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic     widespread pain and presence of tender points).   "
223209|NCT00766688|"     The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on     to ongoing treatment with high doses of statin in a double-blind manner in comparison with     placebo, in the management of patients with severe primary hypercholesterolemia considered as     inadequately controlled despite their ongoing statin treatment.      The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C     level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters     will be assessed as secondary objectives.   "
223210|NCT00766701|"     The overall objective of this study is to evaluate whether fluorescence and reflectance     spectroscopy can improve the ability to detect the presence of premalignant lesions on the     cervix.      The specific aims of the study are:        -  To compare information obtained from fluorescence and reflectance spectroscopic          measurements of the cervix with standard methods for detecting cervical pre-cancers.        -  To validate previously developed algorithms for discriminating between normal and          pre-cancerous tissue based on spectroscopic measurements.        -  To evaluate the safety of spectroscopic measurement of cervical tissue.   "
223410|NCT00775073|"     This is a prospective open label clinical trial in patients with advanced or metastatic liver     cancer to assess the clinical and biological activity of RAD001 (Everolimus) in conjunction     with Bevazicumab (Avastin). Approximately 36 patients will be enrolled.   "
223212|NCT00766740|"     Available data from randomized trials on thrombectomy in patients with ST-elevation     myocardial infarction have shown favourable trends on myocardial reperfusion. Better     myocardial reperfusion may translate in better late clinical outcome. However, only few data     are available on the impact of thrombectomy on long term clinical outcome.      Thus, the investigators designed a collaborative individual patient-data pooled-analysis     aimed to assess the long-term clinical outcome in STEMI patients randomized to percutaneous     coronary intervention with or without thrombectomy.   "
223213|NCT00766753|"     This is a single-institution Phase I/II study designed to evaluate the safety and induction     of an immune response, and preliminary clinical response of vaccinations with Type-1     alpha-DCs (alpha-DC1) loaded with glioma-associated antigen (GAA) epitopes and administration     of poly-ICLC in patients with recurrent malignant gliomas. Approximately 30 subjects will be     enrolled in this study at UPMC/UPCI Hillman Cancer Center. The study participants in this     trial will be HLA-A2 positive male or female adults over 18 years of age. The primary     objective is to establish the safety of this approach. The endpoints will be to determine the     maximum tolerated dose (MTD) of alpha-DC1 vaccines in combination with a fixed dose of     poly-ICLC, using standard criteria and close clinical followups. The secondary objectives are     1) to assess the immunological response against GAAs in patients with recurrent malignant     gliomas immunized with DCs loaded with GAA-derived peptides using enzyme-linked immuno-spot     (ELISPOT), delayed-type hypersensitivity (DTH) and tetramer assays; and 2) to assess the     preliminary anti-tumor clinical activity of the vaccines as measured by radiological response     (MRI), overall survival, and 4- and 6-month progression-free survival (PFS).   "
223237|NCT00772655|"     This is a European multicenter study of 90Yttrium-Ibritumomab Tiuxetan (90Y-Ibritumomab     Tiuxetan) (Zevalin®) as a front line therapy for patients with follicular lymphoma grade     I-IIIa and stage III-IV (as well as for selected patients with extended abdominal stage II).     For patients with complete clinical remission but persistent molecular disease subsequent to     90Y-Ibritumomab Tiuxetan treatment a consolidation immunotherapy with Rituximab is added, to     eradicate minimal residual disease.   "
223684|NCT00778791|"     The objective of this study is to compare the relative bioavailability of metformin HC1 750     mg extended-release tablets (Ranbaxy) with that of Glucophage® XR 750 mg tablets (Bristol     Myers Squibb) in healthy, adult, subjects under fasting conditions.   "
223214|NCT00766766|"     SMOKN5 is aimed at studying ways to reduce environmental tobacco smoke (ETS) for children who     are being treated for cancer. The study includes St. Jude parents whose child lives with at     least one adult smoker who exposes the child to ETS, also called secondhand smoke. We are     comparing two groups of parents to see which group results in lower ETS exposure levels for     the child being treated with cancer. The first group will receive the standard information     and advice usually given to parents about secondhand smoke. The second group will take part     in a new program designed to reduce ETS. The primary objective of the study is to determine     the efficacy of an environmental tobacco smoke intervention compared to the standard care     control condition, as measured by parent report. Parents in each group answer questions about     ETS exposure. We also collect urine samples from the child at specific time points throughout     the study. The urine is tested to measure the amount of cotinine, a metabolite of nicotine.     Measuring cotinine tells us how much nicotine from tobacco smoke the child has been exposed     to. Children who are at least 10 years of age or older will also be asked to complete a set     of questions pertaining to their tobacco use history and ETS exposure from others. This will     occur at the same five time points in which the parent completes his/her portion. The study     will last about 12 months for each participating family. Parents who take part in the study     may learn how to lower their child's exposure to ETS, and this may, in turn, lower the     child's chances of having ETS-related health problems.   "
223216|NCT00766792|"     Dialysis patients, who decide to switch from standard dialysis (3 times 240-270 min/week) to     nocturnal dialysis (3 times 480 min/week), will be followed. In parallel a control group with     patients staying on standard dialysis will be followed. The study will last 30 weeks. During     this period blood samples (pre- and post-dialysis: 10 times; inlet and outlet of dialyzer: 3     times) will be collected on predetermined time points. Concentration of several uremic     retention solutes will be determined.   "
223217|NCT00766805|"     Background: Both endoscopic variceal ligation (EVL) and propranolol are valuable methods for     secondary prophylaxis of variceal bleeding. Addition of ISMN to propranolol improves the     efficacy of drug therapy. It is hypothesized that a combination of EVL and portal pressure     reducing drugs should significantly be better than EVL alone.      Patients and Methods: Patients with history of variceal bleed were randomized to EVL plus     drugs (propranolol and ISMN) or EVL alone. EVL was repeated every 3-4 weeks until variceal     eradication. Propranolol dose was adjusted to reduce the resting heart rate to 55 bpm. Dose     of ISMN was 40 mg/d. Primary end points were rebleed or death. Secondary end points included     complications of portal hypertension and the development of serious adverse effects to     therapy.   "
223218|NCT00766818|"     In this study, we are looking at blood concentrations of Kaletra in HIV positive patients     during pregnancy. The patients will come in for 4 visits lasting ~24hrs. These visits take     place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week     30), we will increase your dose to 2 adult Kaletra tablets, and one pediatric Kaletra tablet     (total dose 500/125mg). The dose will remain increased until you are 2 weeks post partum,     then it will return to the standard 2 adult tablets (400/100mg).   "
223219|NCT00766831|"     The purpose of this is study to evaluate improvement of sleep disorder caused by cancer pain     after the administration of Hydromorphone Oral Osmotic System (OROS) in Korean participants     with cancer.   "
223220|NCT00766844|"     The study investigates safety, feasibility and effectiveness of cervical spinal cord     stimulation (SCS) in prevention of cerebral arterial vasospasm following aneurysmal     subarachnoid hemorrhage (aSAH).      It is postulated that 2 week long stimulation of the cervical spinal cord using an implanted     epidural electrode will prevent or decrease severity of cerebral arterial vasospasm following     aSAH.   "
223221|NCT00766857|"     The purpose of this study is to determine if exenatide will improve global cardiac function     in patients with type 2 diabetes mellitus and congestive heart failure, by favorable effects     on cardiac metabolism leading to improvement of cardiac efficiency.   "
223222|NCT00766870|"     The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed     dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive     Disorder.   "
223258|NCT00773032|"     The purpose of this study is to investigate whether        1. pharmacologically enhanced naps will show increases in specific sleep stages        2. whether these sleep stages will produces specific increases on memory tests        3. whether older adults will benefit more than young adults from increased SWS or Stage 2          on subsequent declarative and motor memory tests.   "
223223|NCT00766883|"     This study will examine the effectiveness of problem-solving education for patients who are     undergoing a stem cell transplant and their caregivers. The emotional stress of transplant     extends beyond patients to their caregivers; this study will identify the type of education     that will be most helpful to transplant caregivers.      Adult patients undergoing stem cell transplant at the NIH s Clinical Center and their adult     caregivers are eligible for this study. The caregiver must be caring for the patient from     before hospital admission for the procedure until 6 weeks following the transplant. Both     patient and caregiver must be able to read and speak English.      Patients and caregivers have three education sessions (in addition to the routine transplant     education provided at the Clinical Center) and complete three study questionnaires as     follows:        -  Questionnaires: The questionnaires vary somewhat for patient and caregiver, but include          information on demographics (e.g., sex, race, marital status, education level),          distress, lifestyle, relationship with the caregiver/patient, confidence level,          symptoms, pain, fatigue and sleep quality. Questionnaires are completed before the          patient undergoes the transplant (and before attending any education sessions), before          the patient is discharged from the hospital and 6 weeks after hospital discharge.        -  Education sessions: The 60-minute sessions are designed to teach problem-solving          strategies by looking at problems in a new way and learning effective communication          skills. The sessions are conducted before the patient is discharged from the hospital, 1          week after discharge and 3 weeks after discharge.   "
223262|NCT00773084|"     This study is being conducted to compare the effects that 2 different combinations of heart     failure medications have on the levels of certain blood markers which cause and/or worsen     heart failure. Additionally, the investigators will investigate any differences that may     exist between Hispanics and Non-Hispanics. The investigators hope to find that Hispanic     Americans will have a greater response to this new regimen compared to non-Hispanic     Americans.   "
223224|NCT00766896|"     STUDY QUESTIONS        -  What is the real prevalence of platelet resistance to aspirin during the acute phase          of stroke and after 3 months, and 1 year, as measured using different platelet function          tests?        -  Do all methods measure similar levels of resistance, or are some methods more sensitive          than others?        -  Does this resistance result in a worse clinical prognosis? Is this result independent of          other variables?      OBJECTIVES        1. Hospital Phase (Acute Stroke)             -  Determination, using various methods, of the prevalence of platelet hyperreactivity               in patients treated with aspirin to treat ischemic stroke (acute phase)             -  Comparison of different assessment methods and identification of the most accurate               of these             -  Identification of variables that correlate with platelet hyperreactivity        2. Follow-up Phase             -  Correlation between platelet hyperreactivity and important clinical outcomes at 12,               24, and 36 months             -  Correlation between platelet hyperreactivity and death or dependency at hospital               discharge, at 3, 12, 24, and 36 months (Modified Rankin Scale)             -  Correlation between platelet hyperreactivity and recurrent stroke of any type             -  Correlation between different methods for evaluating platelet functions and               identification of the most accurate method             -  Analysis of hyperreactivity over time      THE STUDY        -  The study will include 200 consecutive patients seen in the emergency department of a          large, urban hospital (1500 inpatient beds) and diagnosed with stroke in the acute          phase; these patients will be treated with aspirin for an undetermined period        -  The investigators will not include patients who require full anticoagulation treatment,          regardless of the cause        -  Importantly, the analysis of primary and secondary outcomes will be carried out after          blinding the examiner to the results of the platelet aggregation tests      PLATELET TESTS        -  Whole Blood Aggregometer, ChronoLog        -  VerifyNow, Accumetrics        -  PFA-100, Siemens        -  Plateletworks, Helena        -  Impact-R, Diamed        -  Serum thromboxane B2   "
223225|NCT00772499|"     The purpose of this study is to compare in patients with primary hypertension, the non-blood     pressure lowering effects of one-year therapy with olmesartan medoxomil vs. those of atenolol     on changes in the vascular structure and function.   "
223226|NCT00772512|"     The purpose of this study is to determine if PF-04802540 decreases REM sleep.   "
223227|NCT00772525|"     The primary objective of the study was to evaluate the effect of Nerispirdine (50 mg or 400     mg) and placebo given orally as a single dose once a week in crossover design on latency of     Visual Evoked Potentials (VEP) P100 in optic nerves.      Secondary objectives included evaluation of the effect of Nerispirdine on VEP amplitude and     other visual parameters including visual acuity and contrast, as well as evaluation of the     safety and tolerability of Nerispirdine in patients with Multiple Sclerosis (MS).      Contrast sensitivity and visual acuity examinations (in addition to Optical Coherence     Tomography [OCT] and VEPs) were needed during the screening period for defining etiologic     relationships (if non-MS related impairment) and for assessing the effect of treatment of     age-related eye disease versus the MS-related vision impairment.   "
223228|NCT00772538|"     The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate     the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to     placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined     as add-on controller therapy on top of usual care in patients with severe persistent asthma.      The primary objective of each trial is to evaluate the long term efficacy of tiotropium over     placebo on top of usual care in patients with severe persistent asthma as determined by     pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on     asthma control and health care resource utilisation. The secondary objective of each trial is     to compare the long term safety of tiotropium with placebo in this patient population.   "
223229|NCT00772551|"     Evaluation of the pharmacokinetics and safety of raltegravir and ezetimibe when     co-administered to male and female healthy volunteers.   "
223230|NCT00772564|"     The administration of high dose HMG-CoA reductase inhibitors (Statins) to patients with acute     ST-elevation MI (hypoxia/ischemia) who are treated with primary PCI (reoxygenation/     reperfusion) will protect their cardiomyocytes from death and thus preserve LV ejection     fraction.   "
223231|NCT00772577|"     Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril     in Obese patients (BMI ≥ 30) with Stage 2 Hypertension   "
223232|NCT00772590|"     A research study to measure the effect on CD4 counts of adding to current anti-retroviral     regimen raltegravir with or without hyper-immune bovine colostrum.   "
223233|NCT00772603|"     Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults     with partial onset seizures   "
223234|NCT00772616|"     Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative     hyperalgesia. We have developed two automated bispectral index - guided drug delivery     systems: one for propofol administration, the other for combined propofol and remifentanil     administration. Both systems achieve the same objective: similar level of anesthesia     indicated by bispectral index levels between 40 to 60. We make the assumption that this     method of automated remifentanil administration may avoid postoperative hyperalgesia.     Patients scheduled for abdominal surgery will be divided into two groups:        -  in one group, patients will receive automatically delivered propofol and manually          delivered sufentanil according to the usual criteria,        -  in the other group, patients will receive propofol and remifentanil both automatically          administered.      Assessment of postoperative hyperalgesia will be primarily based on morphine consumption     (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.   "
223235|NCT00772629|"     This study was designed to generate data for the assessment of Meningococcal Polysaccharide     Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years.      Primary Objective:      To describe the antibody response to each serogroup prior to, and 4 to 6 weeks following, the     administration of one dose of the investigational Meningococcal Polysaccharide Diphtheria     Toxoid Conjugate vaccine (Menactra®), as measured by serum bactericidal activity using baby     rabbit complement (SBA BR) in participants in each of the two study groups.      Secondary Objective:      To collect reference sera for the development and refinement of laboratory assays for the     measurement of antibody responses to serogroups Y and W 135.   "
223236|NCT00772642|"     This study, conducted by the Malaria Research and Training Center at the University of     Bamako, Mali, and the NIAID, will examine how exposure to the malaria parasite in the womb     affects the developing immune system of newborns. Little is known about how such exposure in     the womb may affect the immune system or alter the risk of malaria or responsiveness to     vaccination after birth. A better understanding of this process may provide information     useful for childhood vaccination strategies in areas where malaria is widespread.      Women 18 years of age and older who live in Bancoumana and are in their last trimester of     pregnancy and in good health may be eligible for this study.      Participants have blood samples drawn from a finger stick and through a needle placed in a     vein two times for this study: when they enroll in the study and again when they go to the     Bancoumana Health Center to deliver their baby. After the baby and placenta are delivered,     blood is collected from the umbilical cord and placenta.   "
223238|NCT00772668|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking     blood flow to the tumor. Giving rituximab together with cyclophosphamide, bortezomib, and     prednisone may kill more cancer cells.      PURPOSE: This clinical trial is studying how well giving rituximab together with     cyclophosphamide, bortezomib, and prednisone works as first-line therapy in treating patients     with stage III or stage IV follicular lymphoma or marginal zone lymphoma.   "
223239|NCT00772681|"     -  To assess the efficacy of docetaxel, cisplatin combination in terms of disease free          survival.        -  Time to progression of the disease in terms of local and distant failure; assess the          survival time, and assess the objective (clinical and radiological) response rate and          the safety of the treatment.   "
223240|NCT00772694|"     Germ cell tumors, a relatively rare disease, but most common malignancy in young males, occur     most frequently in testis. The incidence is about 1%, but is increasing in the majority of     developed countries. The testicular cancer is an extremely important oncological condition     due to his high rate of 80-90% of curability, which can be achieved by combination of     chemotherapy and surgery.      Some of 20-30% of patients will experience disease progression after first line     cisplatin-based chemotherapy and salvage 2nd line conventional-dose cisplatin-based salvage     chemotherapy will result in long term remissions in < 50% of patients (VeIP - vinblastine,     ifosfamide, cisplatin, VIP/PEI - ifosfamide, etoposide, cisplatin, TIP - paclitaxel,     ifosfamide, cisplatin). In multiple relapsed patients the 3rd line chemotherapy can induce     remission in up to 40% (gemcitabine, oxaliplatin), 23% RR (TG - paclitaxel, gemcitabine), 20%     CR (IPO - irinotecan, paclitaxel, oxaliplatin), but only small proportion of them can be     cured, usually with subsequent consolidation surgery. At that stage the disease is usually     chemorefractory and there are no other chemotherapy regimens of proven benefit (7).      The purpose of this study is to determine if multiple-relapsed chemorefractory pts may     benefit from sorafenib monotherapy.   "
223241|NCT00772707|"     The purpose of this study was to demonstrate that current successful fulltime daily wear soft     contact lens wearers using competitive multi-purpose solutions will note improved comfort     when using OPTI-FREE RepleniSH®.   "
223242|NCT00772720|"     Raltegravir is the first of a new antiretroviral class. A better profile of metabolic     toxicity is expected. In order to better define its effects, without interference with other     drugs, a study on healthy volunteers is warranted.   "
223243|NCT00772733|"     The purpose of this study is to ensure the quality of the COPD treatment in primary care by     implementing planned follow-up visits, where the disease condition is evaluated and optimised     in accordance with the national COPD recommendations. If relevant the general practitioner     (GP) will refer patients to COPD rehabilitation conducted by relevant municipality     rehabilitation teams. Secondarily the purpose is to improve collaboration and communication     between the local hospital pulmonologist, GPs and the municipality rehabilitation team   "
223244|NCT00772746|"     The investigators hypothesized that the group of patients receiving the medication     interventions and CBT would show significant changes in their behavior, such as remission or     reduction in anxiety, panic attacks, anticipatory anxiety, fear of body sensations, loss of     control, and agoraphobia avoidance. And also, in the general evaluation of well-being, in the     beginning and end of the treatment, in comparison to the control group (medication without     CBT), during the same period.   "
223256|NCT00773006|"     Advances in mechanical intervention (PCI) and anticoagulation therapy have been the     cornerstone of treatment of patients with coronary artery disease. However, the large     diversity of approaches to anticoagulation during PCI introduces gaps in knowledge regarding     management of cardiac patients. As such, we have initiated a national PCI registry to     elucidate anticoagulant choice, dosing strategies, case selection dynamics, and clinical     outcomes in the Canadian health care environment.   "
223259|NCT00773045|"     The purpose of this study is to evaluate the effect of a pain training program and systematic     measurement of pain scores on actual pain levels and the use of analgesics in critically ill     patients.   "
223245|NCT00772759|"     The primary objective of the study is to investigate the safety and tolerability of single     and multiple once daily ascending doses of AZD3199 delivered as dry powder via the Turbuhaler     inhaler in healthy male Japanese subjects by assessment of incidence and nature of adverse     events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP),     pulse rate, lung function parameters, body temperature and laboratory variables (clinical     chemistry, haematology and urinalysis). The secondary objectives of the study are to     investigate the pharmacokinetics (PK) of single and multiple ascending doses of AZD3199 by     assessment of the degree of accumulation, dose proportionality and time linearity in healthy     Japanese subjects, and to investigate systemic β 2- adrenoreceptor mediated effects of single     and multiple ascending doses of AZD3199 by assessment of potassium and lactate     concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure and     FEV1.   "
223246|NCT00772772|"     The reason for doing this research is that people with kidney disease often suffer from heart     disease. Why this happens is not fully known. A possible cause may be high blood levels of a     substance made by bacteria called endotoxin. The blood levels of this substance are high in     people with medium-level kidney disease.      We want to know if replacing normal amounts of Vitamin D can help lower the levels of this     substance. We also want to know if replacing normal amounts of Vitamin D is associated with     other changes that may help heart disease. We hope that our research will help figure out if     levels of this substance can be lowered by replacing normal amounts of Vitamin D. Normal     subjects are enrolled to have a 'control' set for comparison purposes.   "
223339|NCT00774124|"     Our objective is to test an innovative approach to improve outcomes among underserved women     with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR)     -enabled telephone system to facilitate diabetes control and thereby improve pregnancy     outcomes. Our hypothesis is that Telemonitoring will improve maternal glycemia, thereby     reducing infant birth weights and leading to improved pregnancy outcomes.   "
223247|NCT00772785|"     Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral     tablets, patients experience withdrawal and cravings when the variable BPN levels in the     blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin     that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study     will test the safety and efficacy of Probuphine in the treatment of patients with opioid     dependence. Patients who have completed at least 24 weeks of treatment in the Open-Label,     Multi-Center Study of Probuphine in Patients with Opioid Dependence (PRO-807 Study), will be     re-treated with Probuphine over an additional 24 weeks.   "
223248|NCT00772798|"     TITLE:A Phase II non-comparative study of paclitaxel plus carboplatin in combination with     Vorinostat in patients with advanced, recurrent epithelial ovarian cancer.     INDICATION:Second-line treatment of patients with recurrent platinum-sensitive epithelial     ovarian cancer. RATIONALE:Recurrent epithelial ovarian cancer is today an incurable disease.     The current standard of care consists of systemic chemotherapy using either carboplatin plus     paclitaxel (in platinum-sensitive patients) or single agent chemotherapy with agents like     liposomal doxorubicin, topotecan, weekly paclitaxel or gemcitabine (platinum non-sensitive     patients). The outcome for patients with advanced ovarian cancer nevertheless remains     poor.Preclinical evidence suggests that vorinostat, a potent histone deacetylase (HDAC)     inhibitor, may potentiate the antitumor activity of paclitaxel and/or carboplatin. The study     will assess whether the addition of vorinostat to paclitaxel plus carboplatin is manageable     and induces reasonable response rates in patients with advanced recurrent, platinum-sensitive     ovarian cancer. Biomarkers will be collected from both primary tumors and biopsies before and     after start of treatment with vorinostat.      DESIGN:Phase II, single-center study. All eligible patients will be treated with intravenous     paclitaxel plus carboplatin plus oral vorinostat. Patients will be treated with a maximum of     6 cycles or until disease progression, unacceptable toxicity or withdrawal of consent.     Clinical endpoints will include adverse experiences, progression-free survival (PFS) and     response rate (RR). SAMPLE:Patients must have a histologically confirmed diagnosis of     epithelial ovarian cancer, cancer of the Fallopian tube or primary peritoneal adenocarcinoma.     All patients will have received first-line therapy with carboplatin plus paclitaxel. Patients     should be platinum sensitive, defined as recurrence or progression of ovarian cancer, cancer     of the Fallopian tubes or primary peritoneal adenocarcinoma 6 months or later after the end     of first-line chemotherapy. Patients to be enrolled on this study must have acceptable     performance status and acceptable renal and hepatic function, and be free of other serious     intercurrent illness that could impair their ability to receive protocol therapy. The study     will include up to 55 assessable patients, of which 20 will provide biomarkers. It is     estimated that the inclusion period will last approximately 24 months. DOSAGE/DOSAGE FORM,     ROUTE, AND DOSE REGIMEN Eligible patients will be treated with paclitaxel (175 mg/m2) and     carboplatin AUC5 administered by intravenous infusion (IV) on day 1 of each treatment cycle.     In addition, all eligible patients will receive treatment with oral vorinostat (400 mg)     administered once daily by mouth with food on days -4 through 10 of Cycle 1 (25-day treatment     cycle) and days 1 through 14 of each subsequent 21-day treatment cycle. Patients will receive     antiemetic therapy according to institutional guidelines as well as premedication with     dexamethasone, and antihistamines (an H1-receptor antagonist and an H2-receptor antagonist)     for prevention of the side effects of paclitaxel.   "
223249|NCT00772811|"     Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan     Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma   "
223250|NCT00772824|"     Glutamine, a non essential branched chain amino acid, is most important non toxic nitrogen     carrier in body. It participates in variety of physiological functions. It is a major fuel     source of enterocytes and is a substrate for gluconeogenesis in kidney, lymphocytes, and     monocytes. It is also a nutrient in muscle protein metabolism in response to infection,     inflammation and muscle trauma. The significance of glutamine to metabolic homeostasis     becomes evident during periods of stress, when it becomes a conditionally essential amino     acid. Role of glutamine as protective agent in hepato-biliary dysfunction, in maintaining     mucosal integrity of the Gastrointestinal tract following its administration in patient with     major bowel surgery as a supplement and part of TPN in critically ill patients and in     patients of septicemia, is well established. However the role of glutamine supplementation in     reducing or preventing chemotherapeutic agents induced toxicity in cancer patients is     controversial.   "
223251|NCT00772941|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
223252|NCT00772954|"     This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess     the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine.     Population: healthy male and female adults, 18 to 55 years old.   "
223253|NCT00772967|"     This study will evaluate a walking model of osteoarthritis for use in testing of new     therapeutic agents. The primary hypothesis is that participants treated with Naproxen or     Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during     self-paced walks on Day 3 of treatment.   "
223254|NCT00772980|"     The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in     the treatment of subjective tinnitus in comparison to placebo.   "
223255|NCT00772993|"     Glaucoma is presumed to be an axonal disease which starts at the lamina cribrosa. This     assumption has led to the monitoring of the retinal nerve fiber layer thickness for the     diagnosis and monitoring of progression of glaucoma. However, varying disc size, myopia and     tilted discs affect the thickness of the retinal nerve fiber layer. This study aims to     ascertain the ration of the retinal nerve fiber layer against full retina as a predictor of     glaucoma diagnosis and progression.   "
223261|NCT00773071|"     Nodal staging is a key-step in pre-treatment assessment of gynecological cancers. In recent     years, lymphatic mapping and sentinel lymphadenectomy (LM/SL) as a minimally invasive pelvic     lymph nodes staging has been successfully evaluated in women with early stage of vulvar     cancer, cervical cancer, and endometrial cancer. Such a technique may offer several valuable     advantages: a) it is readily applicable in clinical routine using a safe, inexpensive, and     reproducible protocol; b) it may help to avoid the cost and the morbidity of unnecessary     lymphadenectomy in the majority of cases with uninvolved sentinel lymph nodes; c) it has the     potential to guide the surgeon to nodal regions that are not routinely dissected (i.e.     pre-sacral, para-aortic nodes) and to identify micro-metastases that would have been ignored     otherwise; d) it also offers the basis for sophisticated pathological analysis to detect     sub-microscopic nodal metastases using either immunohistochemical or molecular biological     techniques.      So far, within the abdomen and the pelvis, the LM/SL technique alone is often blinded to the     accurate localization of SLNs. The integration of computed tomography (CT) to single photon     emission computed tomography (SPECT) devices in a single gantry (SPECT/CT) has allowed a     significant gain in terms of diagnostic accuracy and anatomic precision; clinical examples     include malignant melanoma, head and neck cancer, breast cancer, and bladder cancer. In a     seminal series of 26 patients with cervical cancer (Zhang et al., 2006), SPECT/CT was     recently found superior to conventional planar imaging for detection of SLN and accurate     localization. A more recent study (Kushner al., 2007) has also highlighted the technical     feasibility and the clinical added-value of a low-dose SPECT/CT in a series of 20 patients     with early stage cervical cancer (IA2-IIA) who underwent LM/SL.      In the light of the encouraging data from literature and our own preliminary clinical     experience, we hypothesized that the use of LM/SL plus SPECT/CT may be of clinical interest     in patients with gynecological cancers.   "
223356|NCT00774345|"     The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective     as a maintenance therapy at improving further the quality of the response you achieved with     your last therapy and at prolonging the duration of your response. This study will compare     the effects (good and bad) of lenalidomide with the dummy drug.   "
223263|NCT00773097|"     The purpose of this study is to evaluate the immune response to MUC1 - poly-ICLC vaccine, an     investigational or study vaccine. The MUC1 - poly-ICLC vaccine is being tested in persons     with a history of advanced adenomatous polyps, the precursor to colorectal cancer. The MUC1 -     poly-ICLC vaccine is being developed to prevent polyps from advancing into colon cancer and     to prevent polyps from recurring.      MUC1 is mucus that is normally present on the lining of the human colon. However, MUC1 is     expressed in a larger amount and in a modified form on adenomatous polyps and colorectal     cancer. These changes in MUC1 are thought to be part of the process of progression from     adenomas toward cancer. The goal of a vaccine is to help the immune system in the body     identify the changes in MUC1 that accompany the progression to cancer and eliminate the     abnormal cells that make abnormal MUC1.   "
223264|NCT00773110|"     The purpose of this study is to determine whether albumin administration during cardiac     surgery is effective in attenuating the development of inflammation following surgery.   "
223265|NCT00773123|"     RT-View utilizes spectral domain technology to assess both RNFL and ganglion cell layer     thickness. This study aims to correlate visual field defects in patients with glaucoma to     both RNFL and ganglion cell layer thickness.   "
223266|NCT00773136|"     Objective: To determine if Lumigan (bimatoprost) causes increased lash length when used in     gel suspension applied to the base of the eyelashes. Methods: Subjects recruited from the     Bascom Palmer Eye Institute were screened and those who met inclusion criteria were enrolled.     Each participant received two vials of gel suspension, which contained bimatoprost and normal     saline, respectively, each mixed 1:1 with GonakTM gel and labeled right eye and left eye     according to randomization. The suspension was applied to the eyelashes every evening on the     designated eye for 6 weeks. Lash length was measured with a caliper at enrollment, at weekly     intervals during the study and at 1 and 3 months after study completion. Visual acuity,     ocular symptoms, intraocular pressure and photographs were documented at these same     intervals. Results: The average eyelash growth in the Lumigan group was 2.01mm (vs. control     average of 1.13mm) which was a statistically significant difference (p=0.009). The average     intraocular pressure decreased equally in both groups (2.14 mmHg). No change in visual acuity     or iris discoloration was noted in any of the subjects. Discussion: Our data showed an     increase in eyelash length with use of Lumigan in gel suspension, suggesting that it may have     eyelash lengthening properties.   "
223267|NCT00773149|"     Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface     of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells.     Adult patients with ALL in relapse have less than 10% probability of long term survival. The     present study will test the response rate (partial and complete remission) of refractory ALL     or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be     given for a hematopoietic stem cell transplant.      The use of G-CSF is justified by a possible increase in ADCC.   "
223268|NCT00773162|"     To add to our understanding of the relationship between blushing, symptom severity and     potential mechanisms that underlie blushing in patients with Social Phobia (SP), the     investigators propose comparing SP patients' vascular responses to topical m-N pre and post     treatment with Seroquel or placebo.      Atypical antipsychotics such as seroquel have been used successfully as adjunctive treatments     in other anxiety disorders, including PTSD (Labatte, 2001; Krashin & Oates, 1999; McDougle et     al., 2000; Pfanner et al., 2000; Bogetto et al., 2000) and Generalized Anxiety Disorder     (Katzman et al., 2005). Responses to the blushing exposure will be assessed prior to and     following treatment with seroquel or placebo and at one month following intervention. Levels     of prostaglandin will be compared between groups and will also be correlated with symptom     severity in the clinical groups.      The objective of this randomized, double blind flexible -dose study will be to evaluate the     efficacy , safety and tolerability of seroquel SR 50mg to 800mg and placebo in outpatient     subjects diagnosed with SP. The study will begin with a single week of Seroquel 50mg or     placebo. Subsequently, tablets will be administered by the investigator in a flexible dose     fashion during the visits. Patients will be followed up weekly (biweekly after week 6) and at     the clinician's discretion. After the fist week the patients' dosage will be increased up to     a maximum of 800 mg daily with expected average dose of 300mg dail. This dose will remain     fixed after 8 weeks of treatment until week 16.   "
223269|NCT00773175|"     Randomized (1:1 ratio) study of SC versus IV fluid rehydration in mildly to moderately     dehydrated pediatric patients.   "
223411|NCT00775086|"     The purpose of this single center, randomized, double-blind, 2 way crossover study was to     determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal     contraceptive system.   "
223270|NCT00773188|"     This single arm study will assess the feasibility of use, safety and tolerability of     Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally     advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients     will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic     radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv     administered according to a standard treatment protocol). If no dose-limiting toxicities are     observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3     weeks, in combination with a similar treatment regimen to that of the first cohort. After 5     cycles of combination treatment, Avastin monotherapy will be administered for a further 4     cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is     <100 individuals.   "
223271|NCT00773201|"     The main objective is to research for genetic factors involved in the extreme modifications     of the QT interval of the electrocardiogram in answer to a pharmacological stimulation     (sotalol) and physiological stimulation in the apparently normal general population.      The phenotypic characterization, based on the ventricular repolarisation dynamics will be     used aiming at term of the predictive genetic factors of the acquired long QT syndrome   "
223340|NCT00774137|"     People who undergo coronary artery bypass grafting (CABG) or heart valve surgery may     experience acute kidney injury (AKI) after their surgery. Current medical tests cannot     identify AKI until approximately 48 hours after it occurs. This study will examine three new     biomarkers in blood and urine that may provide a more effective and faster way of predicting     AKI in people who undergo CABG or heart valve surgery.   "
223272|NCT00773214|"     The identification and characterization of individuals who vary in their response to     exercise-induced weight loss is important. Weight loss in response to exercise is variable     and it remains unknown who will succeed, why, and more importantly how to improve weight loss     efficacy.      This study will examine changes in behavioural, metabolic, physiological and biochemical     variables in response to a 12 week supervised exercise programme and evaluate their     association with weight loss in overweight and obese sedentary individuals.      Our hypothesis is that changes in the plasma levels of appetite related hormones undermine     the inter individual variation in weight loss in response to exercise.      This study will improve the understanding of variability to exercise-induced weight loss and     allow more individually tailored and appropriate strategies for weight management programmes.   "
223273|NCT00773227|"     The OCULO-Pharyngeal Muscular Dystrophy (OPMD) is a late onset hereditary muscle disease     which is characterised by the selective affection of the pharyngeal muscles resulting in     swallowing disorders, and by a ptosis from the dysfunction of the levator palpebral superiors     muscles. Swallowing disorders are determinant in the prognosis of the disease, and     potentially life-threatening deglutition, due to aspiration and denutrition. Degenerative     dystrophy of the pharyngeal muscles causes difficulties to prepulse the food bolus in the     pharynx, and the decreased relaxation of the cricopharyngeal muscle induced by the disease     leads to blockage of food in the upper esophageal sphincter. The most common treatment for     the dysphagia in OPMD is a myotomy of the upper esophageal sphincter muscles. However,     although this will relax the constriction of the upper esophageal sphincter muscles and     improve transitory the swallowing, it will not prevent the progressive degradation of the     pharyngeal muscles. This progressive loss of contractility will eventually result in     aspiration and severe difficulty in swallowing, increasing risk of aspiration pneumonia and     severe weight loss which are the most common causes of mortality in OPMD patients.      The protocol which we are proposing is a graft of autologous cell muscles (myoblasts)     isolated from unaffected limb muscles into the pharyngeal muscles of patients diagnosed as     suffering from OPMD. Our aim is to improve both swallowing and the contractile deficit     generated by the dystrophic pharyngeal muscles. A myotomy of the upper esophageal sphincter     will be carried out at the same time as the myoblast transplantation, since we have already     validated the improvement resulting from this surgery. Advantages of this new therapy in OPMD     is the autograft, without risks of rejection, and the graft of myoblasts into the dystrophic     pharyngeal muscles, above the myotomy of the upper esophageal sphincter muscles.      This model of cellular therapy has been studied through a preclinical study performed in     dogs, allowing to valid the procedure and its safety, as well as to study the survival     myoblasts grafted in the pharyngeal muscles.      This protocol is proposed for OPMD patients; it is firstly a safety study of both autograft     and surgical procedure. In addition, the autograft may improve the swallowing disorders and     life-threatening complications induced by aspiration and weight loss, resulting in a     potential individual benefit.   "
223274|NCT00773240|"     The study assess the pharmacodynamic effect and the tolerability of Grazax treatment     initiated in the grass pollen season in subjects with seasonal grass pollen induced     rhinoconjunctivitis   "
223275|NCT00773253|"     The purpose of this study is to determine how to improve treatment of patients with cervical     dystonia who have not been helped with standard Botox injections. This study is for patients     with cervical dystonia who have not benefited from treatment with Botox using conventional     single lead electromyographic (EMG) techniques for injection. The study aim is to see if     these patients may have significantly more benefit if their Botox is injected into muscles     that have been chosen with a multi-channel EMG mapping study of the neck prior to Botox     injection.   "
223276|NCT00773266|"     The purpose of this study is to evaluate the intraocular stability and safety of secondary     iris-fixated IOLs in aphakic patients.   "
223277|NCT00773279|"     This trial is conducted in the United States of America (USA). The aim of this clinical trial     is to assess and compare the effect on blood sugar control of insulin detemir and insulin     aspart or insulin detemir alone administered by a insulin pen PDS290 (FlexTouch®) versus a     Novo Nordisk marketed insulin pen (FlexPen®) in subjects with type 1 or type 2 diabetes     mellitus. Furthermore, the subject's preference of the devices will be investigated by the     use of questionnaires.   "
223278|NCT00773292|"     HAM/TSP is a chronic disease of the spinal cord, caused by a virus called HTLV−I. Worldwide     approximately 20 million persons are infected.Infection with HTLV−I is lifelong, and about 3%     of infected persons will develop this chronic debilitating disease, of which half will become     wheelchair dependent. We, and others, have shown a strong and persistent immune response to     HTLV−I in carriers and patients with HAM/TSP, but this fails to clear the virus. However,     carriers with a low burden of virus in the blood have a low risk of developing disease. The     immune response in these carriers seems better able to kill infected cells. A less efficient     response is associated with a higher viral burden that drives the immune response with a     resultant release of chemicals by the immune cells that inadvertently cause harm, most     especially to cells in the spinal cord. Our understanding of HAM/TSP suggests that targeting     the immune response should improve the health of our patients especially if the disease is     diagnosed early. To identify the best type of treatment we are planning a series of studies     of drugs that target the immune response in different ways. Each has been used in other     inflammatory conditions but never before studied in HAM/TSP. We aim to study the extent and     duration of the clinical response and to associate this with the different effects that the     therapies have on the immune response and on the number of HTLV−I infected cells in the     blood. This in turn will improve our knowledge and understanding of the disease and should     lead to better therapy. This application is in relation to the first study − to explore that     therapeutic benefit of ciclosporin in patients with HAM/TSP.   "
223279|NCT00773305|"     The primary goal of this project is to evaluate the efficacy of prostate seed implantation     for the treatment of early stage prostate cancer for patients treated at Summa Health     System/Akron City Hospital and Salem Community Hospital.   "
223280|NCT00773318|"     Nodal staging is a key-step in pre-treatment assessment of prostate cancer. In patients with     a low probability of nodal metastasis, bilateral pelvic lymphadenectomy is controversial. The     large majority of them (> 80%) are free of nodal disease in obturator and external iliac     stations. On the other hand, skip metastases located outside the standard lymphadenectomy may     be missed, particularly in more proximal nodal stations (i.e. common iliac nodes and     pre-sacral nodes).      In prostate cancer, growing data indicate the potential utility of LM/SL, particularly in     patients with a low pre-test probability of nodal disease. However, very few data have been     reported on the feasibility and the utility of SPECT/CT following LM/SL. In a pilot study     including 11 patients with prostate cancer, Kizu and colleagues used a software image fusion     from separate SPECT and CT studies. These authors concluded to the utility of image fusion to     localize anatomically the SLNs. They also suggested the use of hardware fusion from a single     gantry SPECT/CT device for accurate detection of SLNs. Accordingly, Corvin and colleagues     recently reported the suitability of sentinel node detection in a series of 28 patients with     prostate cancer; in this study, an integrated single slice SPECT/CT device was used to     localize the SLNs.      In the light of the encouraging data from literature and our own preliminary clinical     experience, we hypothesized that the use of integrated SPECT/low-dose multislice CT guided     LM/SL may be of clinical interest in patients with prostate cancer.   "
223281|NCT00773331|"     This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability     of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis     patients with chronic renal anemia. Patients will be randomized to receive either     subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous     epoetin beta in accordance with the prescribed dosing information. In both groups, the     starting dose will be the same as the previous dose of epoetin beta administered in the week     preceding first study drug administration. Patients will be treated for 28 weeks with follow     up 4 weeks after the last treatment visit. The anticipated time on study treatment is 3-12     months, and the target sample size is 100-500 individuals.   "
223282|NCT00773344|"     The primary purpose(s) of this study is to determine the highest tolerated dose of     tanespimycin and to determine anti-tumor activity (via objective response rate) of     tanespimycin in patients with breast cancer who have not previously responded to Herceptin   "
223283|NCT00773357|"     The purpose of this study is to examine whether guanfacine or carvedilol will attenuate the     ability of stress to precipitate smoking lapse behavior in treatment seeking and     non-treatment seeking daily smokers. Participants seeking treatment for smoking will     participate in a smoking cessation attempt after the laboratory sessions. Also looking at     gender differences.   "
223284|NCT00773370|"     This study will compare the Adaptive Physical Activity program (APA) to a less vigorous group     exercise program, (Sittercise) to see if APA leads to greater improvements in walking     endurance, quality of life, and participation in social activities.   "
223285|NCT00773383|"     This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive     disease after deriving clinical benefit (defined as response or stable disease after 12     weeks) from second or third line Tarceva monotherapy will determine the proportion of     patients with progression-free survival at 12 weeks following combination therapy with R1507     and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva     (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints     including overall survival, objective response rate, time to response, time to progressive     disease and duration of response will also be evaluated. The anticipated time on study     treatment is 1-2 years, and the target sample size is <100 individuals.   "
223286|NCT00773409|"     The objective of this long term study is to prospectively evaluate the incidence of NSF in     patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4     and 5 i.e., with an eGFR below 30)who have not had exposure to a GBCA within 10 years prior     to enrollment.   "
223287|NCT00773422|"     The purpose of this study is to examine how medications thought to attenuate the effects of     alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to     resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming     drink, in non-treatment seeking alcohol-drinking daily smokers.   "
223288|NCT00773435|"     The goal of the this study is to determine if Echinacea purpurea stimulates the immune system     in children. For the study, 40 healthy children, 6-11 years old will be randomized to receive     Echinacea purpurea or placebo for 10 days in 3 consecutive months. Blood samples will be     obtained in the children just before starting study medication, during the first course of     medication and either just prior to starting the second course of medication or 50 days     following the last of the three courses of medication. Markers of immune activity in children     receiving Echinacea or placebo will be compared.   "
223289|NCT00773448|"     Blood clots in leg veins (deep vein thrombosis) or lung arteries (pulmonary embolism) that     happen for no reason (i.e. unexplained) are both called unprovoked venous thromboembolism     (VTE). These unexplained blood clots can be the first symptom of cancer. Up to 10% of     patients with unexplained blood clots will be diagnosed with cancer within one year of their     blood clot diagnosis.      These cancers can be found anywhere in the body although the relationship appears stronger     with the pancreas, ovary and liver. Cancer testing in patients with blood clots is     controversial. There is presently a wide variety of expert opinions and practices. Previous     studies showed that a limited cancer screen including a medical history, physical     examination, basic blood work and chest X-ray, will find about 90% of cancers. More recent     and better designed studies showed that the limited cancer screen misses many cancers and     needs to be improved. More extensive cancer testing may find more cancers but is potentially     uncomfortable for patients, costs a lot of money and involves a lot of people.      The comprehensive computed tomography is less uncomfortable, inexpensive, radiological test     made to find many cancers at once. Thus, the scientific question to be asked is: Does a     comprehensive computed tomography miss less cancers than a limited cancer screen in     patients with blood clots?      The main goal of this study is to find out if a comprehensive computed tomography misses     less cancers than a limited cancer screen in patients with unexplained blood clots.      The second goal of the study is 1) to find out if a comprehensive computed tomography finds     more curable cancers than the limited cancer screen; 2) to find out if the patients     diagnosed with cancer are still alive and cancer-free after one year (i.e. the patients with     curable cancer were treated and are doing well); 3) to prove that a negative comprehensive     computed tomography means that the patient will not have cancer and; 4) to find out if a     comprehensive computed tomography is well tolerated and safe for patients.   "
223290|NCT00773461|"     This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and     symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with     active rheumatoid arthritis who currently have an inadequate response to DMARD therapy.     Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks,     in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12     months, and the target sample size is 100-500 individuals.   "
223291|NCT00773474|"     A published phase 2 study reported that lonafarnib was administered as a single agent via     continuous or intermittent oral dosing to 76 women with advanced breast cancer who were     previously treated with chemotherapy and/or with endocrine therapy. Objective response rates     of approximately 10% were observed. This study will determine the rate of progression-free     survival of patients with metastatic breast cancer who receive lonafarnib.   "
223292|NCT00773487|"     The primary objective of this study is to elucidate the effects of Diesel particles on the     allergic inflammation in the airways of asthmatic patients.   "
223293|NCT00773500|"     Our objective is to determine the effects of electronic prescribing on medication safety     including medication errors, near misses and preventable adverse drug events in the     ambulatory setting. Study design will be a longitudinal evaluation of errors early after     implementation and after sustained use.   "
223341|NCT00774150|"     The purpose of this study is to investigate neurobehavioral, affective, and social processes     that may influence and predict treatment response in pediatric anxiety disorders.   "
223342|NCT00774163|"     This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in     healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial     to assess safety and efficacy of Lactobacillus reuteri versus placebo for treatment of     pediatric diarrhea in Peru.   "
223294|NCT00773513|"     This 2 arm safety study will compare the outcome with respect to a composite endpoint of     all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in     CKD participants either on dialysis or not receiving renal replacement therapy under     treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will     be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene     glycol-epoetin beta at the following doses: for participants not already receiving ESA     treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose     of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants     receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will     be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on     the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta     administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs     in accordance with their prescribed dosing information.   "
223295|NCT00773526|"     This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1     of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or     advanced solid tumors. In the first part of the study, groups of patients will by     sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The     starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful     assessment of the safety and tolerability of the previous dose. In Part 2 of the study,     patients with selected tumor types will be randomized to receive either the optimal     biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on     study treatment is until disease progression, and the target sample size is 100 individuals.   "
223296|NCT00773539|"     Transvenous pulmonary vein (PV) isolation using radiofrequency energy is an effective     treatment for atrial fibrillation (1-4). However, rare but potentially life threatening     complications such as thromboembolism (5), PV stenosis (5-10), left atrium-oesophageal     fistula (11) and inflammatory syndromes (12) have been described. In preliminary studies an     alternate approach using cryoenergy induces less endothelial disruption/ thrombus formation     (13), preserves the extra cellular matrix and creates lesions with well-delineated border     zones (14). Therefore, cryoenergy seems to be the ideal form of energy to safely perform PV     isolation.      We therefore hypothesise that in the setting of PV isolation for the treatment of atrial     fibrillation (AF) cryoenergy is less traumatic and therefore reduces systemic inflammatory     responses compared to radiofrequency energy.      78 patients presenting with symptomatic intermittent or persistent AF will be randomised to     PV isolation with either radiofrequency (26 patients open irrigated tip, 26 patients closed     irrigated tip) or cryoenergy (26 patients with cryoballoon). Systemic markers of cell damage     and inflammatory response (t-troponin, CK, CK-MB, vWF, PAI-1, micro particles, platelet     activation/overall function, CRP, IL-6, IL-8, IL-10, TNF alpha, procalcitonin) will be     monitored before, during and 48h after the procedure. Further endpoints include time to     PV-isolation and procedure related complications. Six month clinical follow-up will focus on     freedom from AF and cardiovascular events.   "
223297|NCT00773552|"     In this study we hope to establish the prevalence of urinary urge symptoms (with or without     incontinence) in a multicultural, underserved, hospital clinic population in women between     the ages of 20 and 45. Quality of life (QOL) in these individuals will be examined. The goal     is to show a 15% reduction in number of voids in a 24 hour period in our study population     after 12 weeks of treatment with solifenacin succinate.      Hypothesis: We believe that urinary urge symptoms are under-reported in young women and     believe they pose a significant strain on quality of life on otherwise young, healthy     individuals. Treatment with solifenacin succinate will improve symptoms, in turn improving     QOL for these individuals.   "
223298|NCT00773565|"     The aim of this study is to understand the metabolic changes occurring in fat tissue both     during controlled weight loss that lead to the improvement of type 2 diabetes and other     obesity associated metabolic disorders. The novelty of the study is the analysis of     preadipocytes, a poorly characterized subfraction of the adipose tissue, which provides     adipocyte precursors and thereby strongly influences adipose tissue mass changes. Knowledge     of pathways involved in controlling adipose tissue composition will help to design novel     intervention strategies for the treatment of obesity associated metabolic disorders such as     type 2 diabetes.   "
223299|NCT00773578|"     The allergic respiratory diseases such as asthma or allergic rhinitis are the main chronic     diseases in children. The airway inflammation plays an important role in their     pathophysiology. Several epidemiological studies show that environmental tobacco smoke (ETS)     exacerbates the symptoms of asthma and allergies.      The aim of this study is to assess the impact of environmental tobacco smoke on the     measurement of exhaled nitric oxide (eNO) and biomarkers of nasal inflammation in atopic     asthmatic children.   "
223300|NCT00773591|"     This proof-of-concept study is to assess the potential benefit of botulinum toxin for     patients with sleep-related breathing disorders.   "
223301|NCT00773604|"     The purpose of this study is to evaluate the safety and effectiveness of deep brain     stimulation (DBS) of the subthalamic nucleus (STN)for primary dystonia.   "
223302|NCT00773617|"     This study will compare a new method of treatment for bulimia nervosa (ICAT), integrative     cognitive-affective therapy, to the current standard method of treatment, cognitive     behavioral therapy (CBT).   "
227944|NCT00836030|"     This study is conducted in Asia. The aim of this observational study is to evaluate current     status of diabetes management, control and complications in diabetic subjects in Asia.   "
223303|NCT00773630|"     The primary objective of this trial is to test whether Pletal ODT administered without water     can be considered bioequivalent to Pletal administered with 200 ml water (both treatments     being administered after fasting and at least 30 minutes prior to receiving a light     breakfast) based on the standard pharmacokinetic variables.      The secondary objective is to assess the effect of water and the effect of food on the     administration of Pletal ODT based on standard pharmacokinetic variables.   "
223304|NCT00773643|"     The primary objectives of this study are        -  to procure human temporalis muscle, subcutaneous adipose (fat), and bone tissue samples          from children with craniosynostosis,        -  to grow cells from these tissues in vitro,        -  to evaluate the osteogenic potentials of these cell types.   "
223305|NCT00773656|"     Background:      Between 2000 and 2006, 433 patients were overexposed (8% to 10%) during a course of conformal     radiotherapy for a prostate adenocarcinoma in Jean MONNET hospital, Epinal, France. Among     them, twenty four patients received an additional mean dose about 20%, due to an     inappropriate use of the treatment planning system. Severe adverse events (proctitis,     cystitis, and tissue necrosis) have occurred among most of these overexposed patients. We     propose to develop several research programs in order to increase the scientific knowledge on     iatrogenic effects related to overexposure of ionizing radiation, by studying their     relationship with dosimetric, clinical, biologic and genetic characteristics.      Aim of the study:      To correlate the received doses, the volume of irradiated normal tissues, the events, with     biologic, phenotypic and genetic data.      Primary study endpoint:      Incidence and severity of adverse events related to radiotherapy (according to SOMA - LENT     and CTCAE scales).   "
223306|NCT00773669|"     The primary goal of this retrospective study is to evaluate the male breast cancer patient     population at Summa Health System/Akron City Hospital over a period of 18 years and compare     the findings to historical data.      The objectives are to:        -  identify risk factors.        -  evaluate stage and histology at the time of presentation.        -  document treatment modalities and outcomes.        -  analyze outcomes for comparison to historical data.   "
223307|NCT00773682|"     Objective      To assess both the short-term and the long term effectiveness of spa therapy in patients with     primary hand osteoarthritis (OA) in a single blind, prospective controlled, randomized trial.   "
223308|NCT00773695|"     This study will evaluate the effect of bevacizumab in combination with chemotherapy or     endocrine therapy, as preoperative treatment, in participants with HER2 negative breast     cancer. Participants will be randomized to receive either chemotherapy (FEC100: Epirubicine     100 milligrams per square meter [mg/m^2], 5-fluorouracil 600 mg/m^2, and cyclophosphamide 600     mg/m^2] for 12 weeks followed by taxane (paclitaxel/docetaxel) for 12 weeks or endocrine     therapy (an aromatase inhibitor] daily for 24 weeks) with or without bevacizumab (15     milligrams per kilogram [mg/kg] as intravenous [IV] infusion every 3 weeks up 24 weeks).   "
223309|NCT00773708|"     This study aims to provide new knowledge about the pathogenesis of HIV infection,     specifically, the role that immune activation and apoptotic activity play in immune recovery,     and in particular, in the paradoxical immunologic response of some patients on antiretroviral     therapy despite achievement of sustained and complete viral suppression. In this regard, the     investigators will prospectively evaluate the impact of intensification with Raltegravir in     those discordants patients with high index of immune activation, measured as the percentage     of CD8+HLADR+CD38+ cells. This will provide relevant information on the effectiveness of this     drug in guided intensification regimens.   "
223310|NCT00773734|"     The purpose of this study was to test if the drug apremilast was safe, if it helped improve     psoriasis, and how well the participants tolerated it.   "
223311|NCT00773747|"     Study of the efficacy and safety of bortezomib administered in combination with vorinostat in     patients with relapsed or refractory multiple myeloma. Histone deacetylases (HDAC) facilitate     gene transcription by modulating the uncoiling of chromatin. HDAC function is dysregulated in     hematologic and solid malignancies, and this dysregulation may result in over-expression of     oncogenes. Thus, inhibition of HDACs may result in anti-cancer effects. HDAC inhibitors, like     vorinostat, represent a new class of antitumor agents that have the ability to induce     antiproliferative effects including cyto-differentiation, cell cycle growth arrest or     apoptosis in various cancer cell lines. Several studies have investigated the in vitro     antimyeloma activity of vorinostat in combination with bortezomib and have demonstrated that     vorinostat may act synergistically with bortezomib to modulate tumor cell growth. Mitsiades     et al have shown that vorinostat enhances the sensitivity of bortezomib. Pei et al found that     exposure of human multiple myeloma cell lines & patient-derived multiple myeloma cells to     bortezomib and vorinostat resulted in synergistic interactions as a result of: (1)     Interruption of NF-kB & related signaling pathways (JNK, XIAP, Mcl-1, etc.) (2) Inhibition of     Hsp90 (3)Induction of ER stress signal and (4) acetylation of Dynein/disruption of aggresome     function/formation, salvage for ubiquitinated proteins. In addition a marked increase in     mitochondrial injury, caspase activation, and apoptosis was also observed. Bortezomib is     indicated for the treatment of patients with multiple myeloma. Two Phase I dose-ranging     studies of a regimen combining vorinostat and bortezomib among patients with relapsed as well     asend-stage, refractory multiple myeloma have been conducted. These studies enrolled a total     of 57 patients. In these studies, administration of vorinostat with standard doses of     bortezomib resulted in responses in 20/45 (44%) evaluable patients (Weber et al 2007, Badros     et al 2007). The purpose of the present study is to definitively evaluate the clinical     activity of vorinostat in combination with bortezomib inpatients with multiple myeloma.   "
223312|NCT00773760|"     Patients with certain polymorphism in the MOR and COMT genes will display differences in     their response to analgesics.   "
223313|NCT00773773|"     This is a prospective, serum proteomics study of men who are to undergo prostate biopsy. The     purpose is to determine if proteomic profiles can be used to distinguish between men with     prostate cancer on biopsy from men with no cancer on biopsy.   "
223314|NCT00773786|"     This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this     study will provide proof-of-concept information on whether the (anticipated) additional     bronchodilator effect of Brovana added to tiotropium will lead to a meaningful improvement in     the patient-centered outcome, exercise capacity. This study will only evaluate the effects of     short-term (1-week) administration of Brovana. If results are positive, it would provide     preliminary data for further, multicenter investigations.   "
223315|NCT00773799|"     Data on occurrence of antimicrobial resistant bacteria acquisition in rehabilitation centers     will be collected. After removal of patient identifiers, information regarding the patients     population will be entered into electronic sheet. The phase will last twelve months in each     center.   "
223316|NCT00773812|"     The purpose of this study is to examine the safety and efficacy of mecamylamine for the core     symptoms of autism.   "
226577|NCT00817570|"     The purpose of this study is to test and compare the balance reactions of Tranfemoral     Amputees and able bodied subjects in response to perturbations given by a highly advanced     Virtual Reality system.   "
223354|NCT00774319|"     The purpose of this trial is to compare two different treatments for fit patients with head     and neck cancer:      All patients are given induction-chemotherapy (docetaxel, cisplatin, 5-FU).      Subsequently patients are being randomised into two groups:        -  The first group receives neo-adjuvant chemotherapy ('high' dose cisplatin) and          conventional radiotherapy        -  The second group receives neo-adjuvant chemotherapy ('low' dose cisplatin) and          accelerated radiotherapy.   "
223355|NCT00774332|"     A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL   "
223379|NCT00774657|"     This preliminary study will compare the effectiveness of two-dimensional and     three-dimensional echocardiographic measurements of wall thickness and left ventricular mass     in patients with Aortic Stenosis   "
223317|NCT00773825|"     Genomic imprinting, referring to an epigenetic marking resulting in monoallelic gene     expression, plays a critical role in development. Recently, various imprinting diseases were     reported in animals (Large Offspring syndrome (LOS)) and humans (Beckwith-Wiedemann syndrome     (BWS) and Angelman syndrome (AS)) born after ART. In all cases, an imprinting defect was     involved (loss of methylation at ICR2 in BWS, at SNRPN in AS and at IGF2R DMR2 in LOS). These     data suggest that ART procedures may impair the establishment or the maintenance (following     fertilization) of methylation marks at maternally imprinted loci. In view of these data, the     aim of this study is to determine if children born following ART exhibit an increased risk of     imprinting defects. If the answer is yes, the second objective is to identify the problematic     step in the ART procedure and thus to suppress or modify this step.   "
223318|NCT00773838|"     Study of vorinostat in combination with bortezomib in patients with relapsed or refractory     multiple myeloma after at least 2 prior treatment regimens.      Histone deacetylases (HDAC) facilitate gene transcription by modulating the uncoiling of     chromatin. HDAC function is dysregulated in hematologic and solid malignancies, and this     dysregulation may result in over-expression of oncogenes. Thus, inhibition of HDACs may     result in anti-cancer effects. HDAC inhibitors, like vorinostat, represent a new class of     antitumor agents that have the ability to induce antiproliferative effects including     cyto-differentiation, cell cycle growth arrest or apoptosis in various cancer cell lines.     Several studies have investigated the in vitro antimyeloma activity of vorinostat in     combination with bortezomib and have demonstrated that vorinostat may act synergistically     with bortezomib to modulate tumor cell growth. Mitsiades et al have shown that vorinostat     enhances the sensitivity of bortezomib. Pei et al found that exposure of human multiple     myeloma cell lines &amp; patient-derived multiple myeloma cells to bortezomib and vorinostat     resulted in synergistic interactions as a result of: (1) Interruption of NF-kB & related     signaling pathways (JNK, XIAP, Mcl-1, etc.) (2) Inhibition of Hsp90 (3) Induction of ER     stress signal and (4) acetylation of Dynein/ disruption of aggresome function/formation,     salvage for ubiquitinated proteins. In addition a marked increase in mitochondrial injury,     caspase activation, and apoptosis was also observed.      Bortezomib is indicated for the treatment of patients with multiple myeloma. Two Phase I     dose-ranging studies of a regimen combining vorinostat and bortezomib among patients with     relapsed as well as end-stage, refractory multiple myeloma have been conducted. These studies     enrolled a total of 57 patients. In these studies, administration of vorinostat with standard     doses of bortezomib resulted in responses in 20/45 (44%) evaluable patients (Weber et al     2007, Badros et al 2007). The purpose of the present study is to definitively evaluate the     clinical activity of vorinostat in combination with bortezomib in patients with multiple     myeloma.      Based on the preliminary safety & efficacy presented by Weber et al and Badros et al at ASH     2007, this protocol will further evaluate the clinical activity of vorinostat in multiple     myeloma.   "
223319|NCT00773851|"     Hernia of the abdominal wall occur frequently after various surgical procedures of the     abdomen and are increasingly performed by laparoscopic means. Different mesh fixation     techniques are applied, but the influence of mesh fixation on shrinkage is not known in human     patients. Therefore, mesh shrinkage was assessed using two different techniques for fixation.   "
223320|NCT00773864|"     Medical staff will be screened for MRSA and ESBL (including: doctors, nurses, nurse aids,     physical therapists, dietitians, Janitors and other medical staff).      PURPOSE:      To define the carriage of, and risk factors for carriage of resistant organisms among     healthcare employees of carriers of resistant bacteria.      To define activities of healthcare employees who likely to lead to dissemination of resistant     bacteria in rehabilitation centers.   "
223321|NCT00773877|"     Measurement of RNFL thickness by OCT is at a cornerstone for the correct diagnosis and     monitoring of progression of glaucomatous optic neuropathy.      Spectral domain technology has enabled better reproducibility with better axial resolution in     the measurement of RNFL thickness. A comparative study among Stratus, Cirrus and RT-View will     enable clinicians to determine differences among various instruments.   "
223322|NCT00773890|"     This study is designed to assess the safety, tolerability, and activity of TRF-1101 on     microvascular blood flow, vascular endothelial injury, and vasoocclusive pain associated with     sickle cell disease.   "
223323|NCT00773916|"     The purpose of this study is to investigate the association of adverse environmental factors,     parental psychopathology, family functioning and genetic factors and the response to     methylphenidate treatment in children and adolescents with Attention Deficit/Hyperactivity     Disorder.   "
223324|NCT00773929|"     The purpose of this study is to determine the safety and toxicity profile of TAK-593 and     determine the maximum tolerated dose of TAK-593.   "
223325|NCT00773942|"     The purpose of this study is to determine if a medication therapy management program designed     to reconcile a patient's medications and identify and resolve drug related problems can     reduce adverse drug events and other measures of safety and improve patient satisfaction.   "
223326|NCT00773955|"     This phase II trial is studying how well R-(-)-gossypol acetic acid works in treating     patients with recurrent extensive-stage small cell lung cancer. Drugs used in chemotherapy,     such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing.   "
223327|NCT00773968|"     This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety     and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA)     in predialysis participants with chronic renal anemia. Participants currently receiving     subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy     polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or     360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week     -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range     of 10 to 12 grams per deciliter (g/dL).   "
223328|NCT00773981|"     Anastomotic leakage is a major and potentially mortal complication with an incidence of     10-13% after resection of the rectum. For patients showing no clinical signs of peritonitis,     the traditional method has been a conservative treatment with transrectal rinsing. This     treatment is often associated with a very protracted postoperative course with healing times     of up to a year or more for the anastomotic leakage.      Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy.      The objective of this study is to investigate the effects of transrectal vacuum treatment on     the healing of anastomotic leakage after rectum resection in a prospective, randomized,     controlled multicentre trial in 60 patients found to develop clinically significant     anastomotic leakages after elective rectal resection.   "
223329|NCT00773994|"     This prospective research study seeks to determine how the normal velopharyngeal mechanism     compares, both anatomically and physiologically, with previous data obtained on subjects with     submucous cleft palate (SMCP) in IRB#07080395.   "
223330|NCT00774007|"     Emerging evidence indicates the presence of low-grade mucosal inflammation and its     pathogenetic role in IBS. The aim of this pilot study is to provide that mesalazine treatment     of IBS patients reduces low grade colonic inflammation.   "
223343|NCT00774176|"     The overall purpose of PA-SCOPE is to determine why black and rural residents of Pennsylvania     might be at higher risk for deadly, debilitating, and costly hospitalizations for chronic     obstructive pulmonary disease (COPD)— and then to show that repeat acute exacerbations in     high-risk patients can be reduced with one simple intervention. We believe that 1) COPD     patients who are black or who live in rural areas of Pennsylvania are at higher risk of acute     exacerbations requiring hospitalization and 2) this elevated risk can be reduced with one     simple intervention: access to a 1-800 Temple Call Center where patients can get immediate     customized advice on managing COPD exacerbations in their early stages. We will test these     beliefs in PA-SCOPE. The collaborators with Temple University Hospital on the PA-SCOPE     project are Lancaster General Hospital, Western Pennsylvania Hospital, and the Philadelphia     College of Osteopathic Medicine.   "
223344|NCT00774189|"     The objective of the study was to compare the single-dose oral bioavailability of     Clarithromycin 250 mg tablets of Ranbaxy Laboratories with Biaxin 250 mg tablets of Abbott     Laboratories in healthy, adult, human subjects under fasting conditions   "
223345|NCT00774202|"     This study is designed to compare the efficacy and safety of higher doses of Rituxan with a     regimen combining standard doses of Rituxan + CVP in patients with chronic ITP who did not     respond to or relapsed after standard doses of Rituxan. Patients eligible for this protocol     will be stratified into two subgroups according to their initial response to Rituxan.   "
223346|NCT00774215|"     This study is a 1 year review of all patients who had surgery to correct pelvic organ     prolapse (i.e. cystocele, rectocele, enterocele) using the Avaulta synthetic mesh kit.   "
223347|NCT00774228|"     To evaluate the safety and performance of the I-ZIP Ocular Bandage in subjects undergoing     uneventful unilateral clear corneal phacoemulsification with foldable monofocal intraocular     lens (IOL) implantation compared with the Oasis 24-hour Soft Shield Collagen Corneal Shield     (Oasis Medical, Inc. Glendora, California) for providing ocular protection and relief of pain     or discomfort in the acute post-operative period.   "
223348|NCT00774241|"     This single arm study will assess the efficacy and safety of first line combination treatment     with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients     will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6     cycles). The anticipated time on study treatment is until disease progression, and the target     sample size is 100 individuals.   "
223349|NCT00774254|"     This study is part of an effort to learn about interactions between doctors and patients. The     study will use virtual reality technology to examine how patients and doctors interact when     they discuss disease risks.      Men and women between the ages of 25 and 40 who have access to the Internet and were born and     raised in the United States may be eligible for this study. Participants will be recruited     from the Washington D.C. area.      Participants undergo the following procedures:        -  Complete an online questionnaire about their health-related background, family health          history, cancer risk perceptions, and demographic information (e.g., age, marital          status, education, etc.).        -  Participate in activities in a virtual reality environment in which they interact with a          virtual doctor in a virtual clinical scenario. For this experiment, participants wear a          head-mounted display that allows them to see the virtual world images.        -  Fill out a second questionnaire after completing the virtual reality activities. This          questionnaire includes information on the participants virtual reality experience, the          information provided in the experience, and questions about themselves and their          background.   "
223350|NCT00774267|"     The objective of the study is to evaluate quantitative changes in mammographic breast density     from baseline to 24 months in postmenopausal women receiving daily doses of either BZA 20     mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, Raloxifene or placebo. The primary endpoint in this     study is the change in mammographic breast density between baseline and month 24 for each     group.   "
223351|NCT00774280|"     1. At the same time of registration, patients will be randomized to one of the two          conditioning therapy groups; Arm I (intravenous busulfan plus cyclophosphamide; BuCy) or          Arm II (intravenous busulfan plus fludarabine; BuFlu).        2. Randomization will be a stratified permuted-block design. 2.1The patients will be          stratified into standard risk vs. high risk group, and related vs. unrelated donor.          Standard risk group will be defined as follows: patients with acute leukemia in first          remission, CML in chronic phase, and MDS (RA or RARS categories). High risk group will          be defined as follows: patients with acute leukemia in relapse or in second or          subsequent remission, CML in accelerated or blastic phase, and MDS (CMMoL or RAEB          categories).      2.2.Pre-assigned block size is 8.   "
223360|NCT00774397|"     The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI     201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus     (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated     interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed     in treatment-naïve (TN) and treatment experienced (TE) patients.   "
223352|NCT00774293|"     Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic     association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal     circulation, to alleviate inflammation, haemorrhage, myocardial ischemia and pain. This is a     pilot study; a confirmative study will be set up if this study is positive.      The study treatment will start the day before surgery, and will comprise 5 granules of each     homoeopathic medication, Arnica 5 CH and Bryonia 9 CH, or their matching placebo TID during 5     days, in addition to all routine treatments.) Two groups of 45 patients will be included.     Patients have to be over 18 years, to undergo aortic valve surgery only, have no known     allergy to one of the study drugs, sign a consent form, and must not have received anti     inflammatory drug in the 3 days before surgery. The primary criteria include the amount of     drained liquid from the chest, and the CRP evolution from baseline to the 7th postoperative     day. Secondary criteria address inflammation, haemorrhage, ischaemia, and pain. A follow-up     phone call is given to the patients 30 days after their surgery.   "
223353|NCT00774306|"     The purpose of this study is to determine if certain seizure medications raise levels of     cholesterol and other blood components which could increase the risk of heart attacks and     strokes.   "
234205|NCT00921024|"     The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and     comparator in complicated urinary tract infection   "
223357|NCT00774358|"     Funding Source--FDA OOPD.      Orphan Product Grant Number--1R01FD004091-01A1      Context: Wiskott-Aldrich syndrome (WAS) is a fatal, devastating disease with ill-defined     treatment modalities, which affects young boys. Classic WAS is characterized by a clinical     triad of thrombocytopenia, eczema and severe, recurrent infections. Despite diagnostic and     therapeutic advances most WAS patients die at less than 12 years of age due to infections,     hemorrhage, malignancy or complications from treatments. WAS patients suffer from herpesvirus     infections as a result of poor Natural Killer (NK) cell function (cytotoxicity). In the     laboratory, the investigators have seen correction of WAS Natural Killer Cell (NK) function     after treatment with Interleukin-2 (IL-2).      Objectives: Initiate a prospective clinical trial by treating WAS subjects with IL-2 and     using safety as the primary endpoint. Restoration of NK cell cytotoxicity and effects on     cytoskeletal dynamics are secondary endpoints. The investigators will also observe patient     clinical status (eczema, infections, use of treatment dose antibiotics, food allergies, etc).      Study Design/Setting/Participants: This is a prospective clinical trial treating 9 WAS     subjects in the Clinical Translational Research Center (CTRC) with IL-2.      Intervention: The investigators propose to subcutaneously administer 0.5 Million Units     (MU)/m2 of IL-2 daily to WAS subjects for 5 days. Research treatment will be repeated 2 and 4     months later. Inter-patient dose escalation will be employed to 1 MU/m2 and/or 2 MU/m2 based     on safety as the primary endpoint.      Study Measures: The investigators will observe safety and tolerability measures and perform     assays on subject blood samples prior to and after research treatment to observe improvement     in NK cell function.   "
223358|NCT00774371|"     Overweight or obesity is an established negative prognostic factor in both premenopausal and     postmenopausal breast cancer. Several mechanisms have been proposed to explain the adverse     effect of excess body fat on prognosis following the diagnosis of breast cancer, including     increased circulating sex hormones, insulin, leptin, and various growth factors. Results from     previous studies suggest that specific strategies can facilitate weight reduction and     maintenance of weight loss in this target population. This randomized clinical trial will     recruit 253 overweight or obese women who have been previously treated for early stage breast     cancer and will test whether a multifaceted approach to promoting healthy weight management     can achieve the goal of weight loss and maintenance. Additionally, this study tests whether     weight loss is associated with changes in biological and psychosocial factors, including     eating attitudes and behaviors and health-related quality of life. The intervention     incorporates cognitive-behavioral therapy, increased physical activity, diet modification to     facilitate a modest reduction in energy intake, and strategies to improve body image and     self-acceptance. This approach and intervention have been pilot-tested with breast cancer     survivors in a developmental project, which resulted in the intervention group losing     significantly more weight than the wait-list control group.      Study Aims include: testing whether an intervention that emphasizes increased physical     activity and individualized diet modification to promote an energy imbalance is associated     with a greater degree of weight loss and maintenance of that loss over an 18-month time     period; describing the effect of the intervention on hormones and growth factors; describing     the relationships between body weight and weight reduction and measures of selected     psychosocial factors. Measurements of hormonal and psychosocial factors in this study will     provide insight into the responsiveness of these factors to weight loss in overweight or     obese breast cancer survivors, which will provide an indication of the degree of clinical     benefit that is achieved with the intervention efforts. Results from this study may enable     the development of broader efforts transferable to clinical practice and public health, and     thus, may ultimately have a substantial effect on the risk for recurrence and long-term     survival of the estimated 1.98 million breast cancer survivors in the U.S. today.   "
223359|NCT00774384|"     Meningitis or septicaemia (blood poisoning) caused by group B meningococcal infection (MenB)     is an important cause of death and disability in the UK. Prevention through vaccination     therefore remains a key public health priority. Research from national meningitis vaccine     programmes against MenC, Hib and Streptococcus pneumoniae show us that their success is in     part due to their ability to protect both the vaccinated and the unvaccinated, so−called herd     immunity. This protection probably occurs by reducing carriage of these meningitis bacteria     in the back of the throat (mucosal immunity). How this happens is poorly understood but our     research shows that naturally acquired immunity (transient contact between the immune system     and the meningococcus in the back of the throat without causing disease) may impact on this     process. We believe that to develop a MenB vaccine that is able to cause mucosal immunity and     prevent MenB carriage, it is important to understand the interaction between natural immunity     and vaccination. In this study we propose to administer MenB vaccine to adults in order to     investigate this process. Our findings will provide important insights into Men B immunity,     inform the design of novel vaccine strategies and allow the rational testing of new vaccines     as they become available.   "
223361|NCT00774423|"     This is a multicentric, randomized, double-blind study versus placebo, with two parallel     groups treated to evaluate the efficacy and the tolerance of Riluzole in children and young     adults (6 to 20 years of age) with SMA. (Type II and Type III).   "
223363|NCT00774449|"     Chronic organ dysfunction after lung transplantation (BOS) is the most common cause of death     in long-term survivors after lung transplantation and refractory to most interventions. Early     markers will be established in this project study to overcome the problem of disease     recognition when impairment of graft function is already taken place. Long-term longitudinal     monitoring in stable recipients of innovative markers of airway inflammation and ventilation     and new imaging techniques will define different entities of chronic organ dysfunction after     LTx. A database and specimen service unit for further projects will be created.      Hypothesis: This project will reveal new markers and imaging tools in recipients who develop     BOS after lung transplantation. These tools will allow earlier diagnosis and more accurate     monitoring of the disease process. Different patterns of the disease will be characterized.   "
223364|NCT00774462|"     The traditional treatment of inflammatory myopathies (IM) and generalized myasthenia gravis     (MG) is immunosuppressive therapy, usually beginning with corticosteroids. However, up to 70%     of treated patients show an incomplete response, including 10 - 30% who are unresponsive.     Corticosteroids and other immunosuppressive therapies presented also many side effects. We     propose to evaluate in a pilot, open, prospective, multicentric, phase II study, the interest     of rituximab in the treatment of patients with primary IM associated with specific AAb     (anti-synthetase and anti-SRP AAbs), or MG (with anti-AchR AAbs), refractory to conventional     therapies. Twenty fourth patients with primary IM (12 with anti-synthetase, 12 with anti-SRP     AAbs), and 12 with MG will be included in the study.   "
223365|NCT00774475|"     The purpose of this study is to evaluate the efficacy (reduction of major ischemic events at     6 and 12 months of follow-up) of a tailored clopidogrel therapy in patients with UA/NSTEMI     undergoing PCI with stent implantation and wiht a documented residual platelet reactivity     assessed by a point of care system (VerifyNow P2Y12).   "
223366|NCT00774488|"     This clinical, randomized, cross-over study in obese healthy subjects aimed to analyse the     acute effects of the incretin hormon Glucose Dependent Insulinotropic Polypeptide (GIP) on     metabolic parameters and gene expression in subcutaneous adipose tissue.   "
223367|NCT00774501|"     Liver tumors are hard to treat with radiation because the liver moves every time you breathe.     The purpose of this study is to test a new and possibly more accurate way of treating liver     tumors. When a person is asleep under anesthesia, it is safe to stop breathing motion for a     while. The liver will stop moving and radiation can be given to a liver tumor. The study is     being done to see if radiation can be given to liver tumors safely and accurately in this     way.   "
223368|NCT00774514|"     Exposure to air pollution has been linked to increased cardiorespiratory morbidity and     mortality. The exact component of air pollution that mediates this effect is unknown, but the     link is strongest for fine combustion derived particulate matter derived from traffic     sources. It has been demonstrated that inhalation of diesel exhaust impairs vascular     vasomotor tone and endogenous fibrinolysis. Recent studies using an inline retrofit particle     trap to reduce the particulate component of exhaust have shown that filtering particles leads     to a reversal of the endothelial dysfunction seen after diesel exhaust exposure, and have     even suggested an augmentation of vascular function. This raises the question of the     cardiovascular effects of the gaseous pollutants, the most abundant of which is nitrogen     dioxide. In this study we plan to investigate the cardiovascular effects of nitrogen dioxide     exposure.   "
223369|NCT00774527|"     Randomized comparison of cyclophosphamide versus reduced-dose cyclophosphamide plus     fludarabine in addition to anti-thymocyte globulin for the conditioning therapy in allogeneic     hematopoietic cell transplantation for bone marrow failure syndrome.   "
223370|NCT00774540|"     The purpose of this study is        1. to observe acute pain after surgery and measure the natural course of inflammatory          mediators        2. study pain relieving effects and local anti-inflammatory effects of systemically          administered ketorolac   "
223371|NCT00774553|"     The purpose of this study is to assess safety and tolerablility of AZD1656 after multiple     repeated oral doses in patients with type 2 diabetes on top of metformin.   "
223372|NCT00774566|"     This study is designed as a randomized, controlled, prospective, non-inferiority clinical     trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated)     will be compared to the standard ablation technique (segmental isolation of the pulmonary     veins) with radiofrequency energy. The primary study aim is to investigate whether the new     cryoballoon ablation catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable     Sheath, CryoCath Technologies Inc., Montreal, Canada) is at least as effective as     radiofrequency (RF) segmental isolation in electrically disconnecting the pulmonary veins     (PV) for the treatment of paroxysmal atrial fibrillation (AF) with respect to the absence of     atrial arrhythmias without persistent complications after six and twelve months. Furthermore,     the differences in terms of procedural complications such as pulmonary vein stenosis, phrenic     nerve injuries, cerebrovascular accidents (CVA), pericardial tamponade, pain scores during     the procedure, levels of cardiac inflammatory markers are compared between the treatment     groups. The short and long-term clinical success as well as the costs of both systems will     also be evaluated.   "
223373|NCT00774579|"     We will examine a cohort of growth hormone deficient adults starting growth hormone (GH)     replacement. The purpose of this study is to determine whether GH replacement reduces the fat     content of the liver.      To compare the results we will include growth hormone deficient patients who do not start GH     replacement as controls.   "
223374|NCT00774592|"     This study will examine whether pairing a grade 6 in-school HIV education program and a     parent training program will reduce prevalence of behaviors that present high risk of HIV     infection in youth in the Bahamas.      In a continuation of this study, we shall examine whether an in-school HIV prevention program     delivered to grade 10 students reduces HIV risk behavior and the impact of both the grade 6     intervention and the grade 10 intervention compared to the grade 6 intervention alone.   "
223375|NCT00774605|"     To evaluate the absorption, safety, and tolerability of a varenicline solution and a     varenicline patch applied to the skin.   "
223392|NCT00774839|"     The purpose of this study is to learn more about the social and financial impact of colon     cancer for older patients. We want to know how cancer has affected the patient financially     and socially, and to know if the patient has resource needs that have gone unmet. By doing     this study, we hope to learn about resources that can reduce the financial burden from     cancer.   "
223376|NCT00774618|"     Individuals with non-healing rib fractures may experience significant pain and disability.     This is called rib fracture non-union, an unusual problem and one that most physicians have     little experience with. The investigators hypothesize that surgical repair of rib fracture     non-union is clinically efficacious and safe in 6 month follow-up. The objective of this     study is to evaluate how repairing non-healing rib fractures affects pain and disability.   "
223377|NCT00774631|"     Bacterial meningitis is a severe infection of the envelope which surrounds the brain. It is     sometimes responsible for a cerebral oedema mattering with a loss of consciousness (coma).     The usual treatment of this affection is based on the antibiotic therapy, anti-inflammatory     drug and resuscitation measures in intensive care setting but the prognosis of comatose     patients remains poor.      Moderate hypothermia (body temperature is downed between 32 and 34°C°) made the proof of its     efficiency in certain cerebral pathologies (notably the cerebral distress after cardiac     arrest or oxygen lack in neonates) but was never evaluated in meningitis. In meningitis     animal studies and in severe traumatic brain injury, moderate hypothermia is able to diminish     cerebral oedema and brain inflammation.      Thus, the objective of this study is to compare two strategies: only usual care or usual care     completed by moderate hypothermia. The body temperature will be lowered between 32 and 34°C     by means of a catheter placed in a big vein and connected to a machine in which circulates a     cold liquid, or by means of an external cooling (ice-cold blanket, ice packs placed on the     body). Whatever technique is chosen, the technique is perfectly mastered by the teams which     take charge of the patients. After 48 hours, the technique of hypothermia will be suspended     and body temperature will return passively and gradually to normal.      The investigators believe that moderate hypothermia will improve the prognosis of the most     severe patients.   "
223378|NCT00774644|"     The objective of this study is to compare the relative bioavailability of clarithromycin 500     mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy,     adult subjects under fasting conditions.   "
223380|NCT00774683|"     The purpose of this research sub-study is to learn about the levels of an antiretroviral     (ARV) medication called Raltegravir, and response to HIV virus in the genital tract of     HIV-positive women.      We would like to see how this study medication is tolerated, and how the body processes the     study medication in women who are HIV-positive. More specifically, we are interested in how     Isentress® might penetrate into the female cervicovaginal secretions thereby potentially     reducing the amount of HIV in those secretions. A reduction in the amount of HIV in genital     secretions may prevent female subjects from transmitting HIV to their sexual partners. This     information will help the research team know how a medication such as Isentress® might be     used to prevent the sexual transmission of HIV.   "
223381|NCT00774696|"     The objective of this study is to compare the relative bioavailability of clarithromycin 500     mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy,     adult subjects under non-fasting conditions.   "
223382|NCT00774709|"     Background:      Heart failure with preserved ejection fraction (HFPEF) is common but not well understood.     Electrical dyssynchrony in systolic heart failure is harmful. Little is known about the     prevalence and the prognostic impact of dyssynchrony in HFPEF.      Methods:      We have designed a prospective, multicentre, international, observational study to     characterize HFPEF and to determine whether electrical or mechanical dyssynchrony affects     prognosis. Patients presenting with acute heart failure will be screened.      Inclusion criteria will be:      acute presentation with Framingham criteria for heart failure, left ventricular EF ≥45%, BNP     >100 ng/L or NT-proBNP >300 ng/L. Patients will return in stable condition 4-8 weeks after     the index presentation and undergo questionnaires, serology, ECG and Dopplerechocardiography.     Thereafter, patients will be followed for mortality and heart failure hospitalization every 6     months for at least 18 months. Sub-studies will focus on echocardiographic changes from the     acute presentation to the stable condition and on exercise echocardiography.      Conclusion:      KaRen aims to characterize electrical and mechanical dyssynchrony and to assess its     prognostic impact in the HFPEF. The ancillary study of the exercise stress echocardiography     sought to improve our understanding of HFPEF and generate answers to the question whether     dyssynchrony could be a target for therapy in HFPEF.   "
223383|NCT00774722|"     The purpose of this study is to determine whether metronidazole 10% ointment , applied     topically three times a day in and around the anus, on the reduction of pain following     haemorrhoidectomy.   "
223384|NCT00774735|"     A study in healthy volunteers to determine whether there is a drug interaction between     GSK1349572 and the HIV protease inhibitors lopinavir/ritonavir and darunavir/ritonavir   "
223385|NCT00774748|"     The purpose of this study is to ascertain whether subcutaneous ports are an effective and     reliable way to administer the low molecular weight heparin (LMWH) enoxaparin to patients for     the prevention or treatment of venous thromboembolism.   "
223386|NCT00774761|"     The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two     doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.   "
223387|NCT00774774|"     This work aims to measure the effectiveness of face mask worn by a patient with flu to avoid     transmission to other persons in the household.   "
223388|NCT00774787|"     The purpose of this study is to determine if use of topical imiquimod cream after cryotherapy     of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and     new ones) at follow-up.   "
223389|NCT00774800|"     Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA)     approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase     PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of     other injectable drugs. In this study, rHuPH20 will be co-administered with both Humalog and     Humulin-R in order to determine if it improves the absorption of these insulins to more     closely mimic the body's natural increase in insulin in response to a meal.   "
223390|NCT00774813|"     The primary objectives of this Phase II study are to demonstrate the safety of Nexalin     Therapy and to investigate the efficacy of Nexalin Therapy.   "
223393|NCT00774852|"     This study is for individuals with lupus who have developed complications in their kidneys,     or lupus nephritis. The study will determine whether adding the experimental medication     abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis     than standard cyclophosphamide therapy by itself.   "
223394|NCT00774865|"     The objectives of the 2-year study are two-fold:        1. To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft of          patients who have already had robotically-assisted CABG surgery using CTA and MPS-MIBI        2. To determine patient quality of life at 5-7 years after robotically-assisted CABG          surgery   "
223395|NCT00774878|"     The purpose of this study is to evaluate the clinical activity of AVE1642 in combination with     fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of complete     response, partial response and stabilization of the disease.      The additional objectives are to evaluate the safety profile of AVE1642 in combination with     fulvestrant and of fulvestrant alone, to assess the rate of patients without disease     progression at 6 months and the overall progression-free survival time. An evaluation of the     pharmacokinetics and pharmacodynamics interactions between AVE1642 and fulvestrant will also     be performed.      The biological activity of treatment will be assessed on tumor biopsies, when possible The     potential immunogenicity of AVE1642 will be studied   "
223396|NCT00774891|"     This study will compare the physiologic responses between exercise stress echocardiography     and pharmacologic stress echocardiography on left ventricular volume and wall stress.   "
223397|NCT00774904|"     Plasma adiponectin concentration is inversely associated with renal function. There is little     literature on adiponectin levels and regulation by antihypertensive medication with an     angiotensin II-receptor blocker (ARB), especially in subjects with type 2 diabetes in     different stage of chronic kidney disease (CKD).   "
223438|NCT00775437|"     The main objective of this study is to evaluate the safety of adalimumab in patients 2 to < 4     years of age or ≥ 4 years of age weighing < 15 kg, with moderately to severely active     polyarticular juvenile idiopathic arthritis (JIA) or polyarticular course JIA.   "
234206|NCT00921037|"     The purpose of this study is to determine whether multiple cutaneous neurofibromas in     patients with neurofibromatosis type 1 can be removed with an erbium-YAG-laser.   "
223398|NCT00774917|"     This is a prospective single centre Study designed to assess by OCT the effect of NUMEN     cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native     coronary lesions of patients with Stable Angina Pectoris or ACS (except STEMI).      A total of 60 consecutive patients will be enrolled in the study. Patients with de novo     native coronary artery lesions >10mm and <24mm in length and >2.50mm to <3.50mm in diameter     by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent     implantation. After stent deployment an OCT imaging will be performed within the treated     segment. Patients will be followed at 30 days, 6 months and 12 months post-procedure, with     all patients having repeat angiography and OCT at 6 months.      It is anticipated that the total length of the study will be 18 months: 6 months to complete     patient enrolment and 12 months for follow-up.   "
223399|NCT00774930|"     The purpose of this study was to determine whether monthly deep subcutaneous (s.c.)     injections of lanreotide Autogel (Somatuline Depot) were effective and safe in controlling     diarrhoea and flushing by reducing the usage of s.c. short-acting octreotide as a rescue     medication to control symptoms in subjects with carcinoid syndrome.   "
223400|NCT00774943|"     This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of     repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.   "
223401|NCT00774956|"     The purpose of this study is to investigate the muscle recruitment pattern and the effect of     a 6 week shoulder exercise training program in healthy persons and subjects with shoulder     impingement   "
223402|NCT00774969|"     The purpose of this study is to evaluate the blood levels of Metronidazole after application     to the peri anal area after a single dose and 6 or 7 days application.   "
223403|NCT00774982|"     The study is being conducted to evaluate the pharmacokinetic parameters (Cmax, Tmax and AUC)     of the new delayed release, lowered dose, 40 mg 6MP test formulation as compared to standard     6MP (100 mg Purinethol) in 12 patients with Crohn's Disease.      The study is being undertaken to prove that the new test formulation is indeed     delayed-release and targeted to the ileum, and that the levels of 6MP in the blood following     local absorption are lower than that seen following standard Purinethol dosing. This should     result in lower, safer mercaptopurine dosing, allowing for uninterrupted treatment with fewer     side effects.   "
223404|NCT00774995|"     This study will evaluate the immune response of healthy subjects who received neonatal     vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago. The     presence of immune memory against hepatitis B surface antigen (HBsAg) in these subjects will     be investigated by the administration of a challenge dose of hepatitis B vaccine and the     comparison of their antibody concentration before and one month after vaccination.      This protocol posting deals with objectives & outcome measures of the booster phase. No new     subjects will be recruited during this booster phase of the study.   "
223405|NCT00775008|"     A media lab study will be conducted to determine the mechanism by which podcasting may exert     an effect. This study will examine both physiological (heart rate, skin conductance, etc.)     and psychosocial (knowledge, perceived control, elaboration, etc.) measures in participants     listening to a podcast on health versus reading health content on the Web. We hypothesize     that podcasting will create a greater physiological response than the Web. There will also be     more elaboration in the podcasting group. Podcasting will produce greater feelings of     control. Changes in knowledge will be greater in the Web group.   "
223406|NCT00775021|"     The objective of this study is to evaluate the clinical performance of two daily disposable     contact lenses.   "
223407|NCT00775034|"     Mesh repair for open incisional hernia repair with fibrin sealant or with drainage   "
223408|NCT00775047|"     The purpose of this study is to see if it is a feasible arrangement to have women receive     their second and third birth control injection (with Depo-Provera) at a pharmacy compared     with receiving it a Planned Parenthood Clinic. Compliance with returning for injections as     well as patient satisfaction with the method, providers, and location where injection was     received will be assessed and compared between the two sites. The hypothesis is that there     will be no difference in return rates for injections at either the pharmacy or the clinic     site.   "
223409|NCT00775060|"     To set up a cohort of at least 400 IBS patients in order to identify different patient     subgroups according to phenotypical and genotypical patterns and      To set up a biobank for future translational studies on the pathophysiology of IBS, in order     to identify genetic factors to unravel the pathogenesis of IBS and to provide novel     therapeutic targets.   "
223412|NCT00775099|"     Air pollution is a major cause of cardiovascular morbidity and mortality. The components of     air pollution responsible and the mechanisms through which they might mediate these harmful     effects remain only partially understood. The link between cardiovascular disease and air     pollution is strongest for fine particulate matter. Fine particulate matter (PM) is produced     from the combustion of fossil fuels with the most significant threat thought to be posed by     small particles less than 10µm (PM 10) which can be inhaled into the lungs. We propose to     identify the precise component of diesel exhaust that mediates the adverse cardiovascular     effects using a carbon particle generator, and a particle concentrator. The aim of this study     proposal is to assess the vascular effects of different types and components of air pollution     in healthy subjects. We intend to test the hypotheses that:        1. Combustion derived nanoparticulate causes an acute impairment of endothelial vasomotor          and fibrinolytic function in healthy volunteers.        2. Exposure to combustion derived air pollution is associated with increased thrombus          formation.   "
223439|NCT00769821|"     RATIONALE: Gathering information from breast cancer survivors about lymphedema; its symptoms     and their impact on shoulder, arm, and hand functioning; and quality of life may help doctors     learn more about the disease.      PURPOSE: This clinical trial is studying the impact of lymphedema on breast cancer survivors.   "
223456|NCT00775502|"     This study will test the ability of a specially designed monoclonal antibody to destroy     multiple myeloma cells. This antibody is unique in its ability to promote the death of     multiple myeloma cells by processes known as antibody dependent cellular cytotoxicity     (ADCC)and complement dependent cytotoxicity (CDC). The study is designed to determine both     the optimal dose of the antibody to destroy multiple myeloma cells and frequency of dosing.   "
242376|NCT01021137|"     The purpose of this project is to determine the effects of mild traumatic brain injury and     blast exposure on the inner ear balance and central nervous systems.   "
223413|NCT00775112|"     We have developed a positioning cushion for LP which allows the child to be relaxed in an     adequate position, and to maintain this position throughout LP. This study was aimed at     evaluating the benefit of the device on the technical quality of LPs, on pain, anxiety, post     LP syndrome, and on the satisfaction of children, their parents and caregivers.      The study was a two-centre, open, randomized trial, with two parallel groups. Children aged 2     to 18 years undergoing a LP were eligible, if not included in the study before. Those who had     used the cushion before, with a medical reason preventing the use of the cushion, those     refusing or whose parents refused could not be included. Randomization was stratified by     centre.      Four cushion sizes were available for the age ranges: 2-6 years, 6-10 years, 10-15 and 15-18     years. The primary outcome was the rate of success, defined as a LP reaching its objective at     the first attempt, without hemorrhage (visible hemorrhage or RBC > 50/mm3 in the CSF sample).     Secondary outcomes included: the child's pain using a visual analogic scale (VAS), parents     and caregiver perception of the child's pain (VAS); the children, parents, caregiver and     physician performing the LP satisfaction; children cooperation using the Le Baron Scale,     and the occurrence of a post LP syndrome.   "
223414|NCT00775125|"     The primary objectives are to determine the effect of steady-state DRV/rtv 600/100 mg twice     daily (b.i.d.) on the steady-state pharmacokinetics of telaprevir 750 mg every (q) 8h and     1125 mg q12h and vice versa;- to determine the effect at steady-state of fAPV/rtv 700/100 mg     b.i.d. on the steady-state pharmacokinetics of telaprevir 750 mg q8h and 1125 mg q 12h and     vice versa; to determine the steady-state pharmacokinetics of telaprevir 750 mg q8h versus     telaprevir 1125 mg q12h, alone and during coadministration of either steady-state DRV/rtv     600/100 mg b.i.d or fAPV/rtv 700/100 mg b.i.d.   "
223415|NCT00775138|"     This is a study to determine the safety and tolerability of 28 days of daily dosing of two     doses (280mg and 560mg) of Arikace™ versus placebo in patients who have Bronchiectasis.   "
223416|NCT00775151|"     The objective of this study was to compare the rate and extent of absorption of Ranbaxy     amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one tablet dose in     fed state subjects.   "
223417|NCT00775164|"     The primary objective of this study is to examine the effects of four months of pioglitazone     vs. metformin treatment on HDL cholesterol, triglycerides, blood pressure, insulin     resistance, endothelial function, arterial stiffness, adipokines, oxidative stress, and blood     biomarkers of endothelial activation in obese insulin resistant children. 30 obese children     with elevated fasting insulin levels will be randomly assigned to pioglitazone or metformin     for 16 weeks. Change in clinical variables over the 16-week study period will be compared     between groups.   "
223418|NCT00775177|"     The purpose of this study was to determine the bioequivalence of Doxycycline monohydrate     formulations after administration of single doses to normal healthy subjects under fasted     conditions. These data were to be evaluated statistically to determine if the products meet     bioequivalence criteria.   "
223419|NCT00775190|"     This is a randomized control trial of Ortho tricyclen versus Trinessa (generic equivalent) to     determine if they have similar effects. Women will be randomized to receive either Ortho     tricyclen or Trinessa oral contraceptives and will be asked to keep a daily dairy of any     symptoms or bleeding experienced. Once a month, participants will be asked to complete a     survey.      The objective is to compare generic oral contraceptives (OCPs) and brand name OCPs with     respect to side effect profiles including bleeding patterns, mood changes, nausea and     vomiting, frequency of menstrual cramps, breast tenderness, elevation in blood pressure,     stroke, blood clots and patient compliance.   "
223420|NCT00775203|"     The purpose of this study was to demonstrate efficacy, safety and clinical benefit of     Trazodone Contramid® OAD (Once A Day) in the treatment of Unipolar Major Depressive Disorder     (MDD).   "
223421|NCT00775216|"     Health disparities related to obesity, pre-diabetes and Type 2 diabetes in the United States     represent public health concerns. Given the benefit of exercise in disease prevention and     management, evidence-based, cost-effective, brief interventions are needed to improve patient     outcomes related to Type 2 diabetes and associated conditions. This novel behavioral     intervention study connects individuals with resources within their community to affect     change in their health and wellness. The aim is to connect disparate individuals to health     and wellness resources to prevent the onset of diabetes. This will be accomplished through a     collaborative effort with Vanderbilt Diabetes Center, Nashville Metro Parks and Recreation,     and the Metro Public Health Department.      A time series design will be used to assess the efficacy of physical activity counseling     delivered by a health care professional, plus continued contact intervention delivered via a     proactive and reactive health promotion counseling hotline that will leverage our partnership     with Metro Parks versus counseling advice alone. In order to refine this intervention (Phase     II) before it is executed, focus groups will first be conducted in Phase I with members of     the target population in order to obtain feedback on the proposed intervention activities and     materials. Qualitative findings and feasibility testing will be the basis for modifying the     intervention.   "
223422|NCT00775229|"     This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania   "
223757|NCT00781105|"     The Chinese PAC study (CLDT600ACN03) will evaluate the efficacy and safety of open label     telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of     the study is the proportion of patients achieving undetectable HBV DNA at week 52.   "
223423|NCT00775242|"     During menopause a woman's body slowly produces less of the hormones estrogen and     progesterone. Lower hormone levels in menopause may lead to hot flashes, vaginal dryness and     osteoporosis. To help with these problems, women are often given estrogen or estrogen with     progestin. The purpose of this study is to assess and compare the efficacy and safety of     three doses of estradiol and progesterone for the treatment of the climacteric symptoms   "
223424|NCT00775255|"     To compare the single-dose oral bioavailability of clarithromycin 250-mg/5 mL powder for oral     suspension of Ranbaxy Laboratories with that of Abbott Laboratories (Biaxin®) following     administration of a 250 mg/5 mL dose in healthy, adult, human, male subjects under fasting     conditions.   "
223469|NCT00775671|"     Test the hypothesis that nebivolol treatment improves fibrinolytic balance and insulin     sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.   "
223425|NCT00775268|"     Background:        -  Positron emission tomography (PET) uses radioactive substances called tracers to locate          areas of cancer in the body. For this test, the patient is given an injection of tracer          and lies in a large donut-shaped scanner that detects where in the body the          radioactivity accumulates. Computed tomography (CT) scans use low dose x-rays that help          to better localize where the radioactive tracer is concentrating. PET/CT scans are          usually done in lymphoma patients before treatment starts and at the end of treatment to          evaluate the response to therapy.        -  PET scans typically use a sugar-like radioactive tracer called fluorodeoxyglucose (FDG)          and low-dose x-rays. Sometimes, however, FDG PET scans show what looks like active          disease and presence of a mass after chemotherapy even when there are no live cancer          cells. Doctors have particular problems in evaluating response to treatment when this          happens because they can t tell if the mass is active cancer or just dead tumor cells.        -  An experimental tracer called 18F- fluorothymidine (FLT) has high uptake in active tumor          cells and may be better able to evaluate treatment response.      Objectives:      - To test the use of FLT PET/CT imaging in assessing treatment response in patients with     lymphoma.      Eligibility:      - Patients 18 years of age or older who are enrolled in a lymphoma therapy study at the NIH     Clinical Center or in the CALGB 50330 study at another location.      Design:      - There are two arms in this study:        -  The first arm evaluates FLT as an early predictor of tumor response to therapy. Patients          are imaged with FLT and FDG PET before starting treatment, following two cycles of          therapy and after treatment ends.        -  The second arm evaluates the ability of FLT to distinguish if a mass that remains after          treatment is active cancer or dead tissue. Patients who have completed treatment and in          whom FDG PET shows a remaining tumor mass are imaged with FLT PET. Following the scan,          the tumor is biopsied for verification.   "
223426|NCT00775281|"     Interstitial cystitis (IC)/chronic pelvic pain syndrome (CPPS) is a clinical syndrome of     pelvic pain and/or urinary urgency/frequency in absence of a specific cause such as bacterial     infection or damage to the bladder. The pathogenetic mechanisms of IC/CPPS are as yet     undefined and it is largely this lack of knowledge, which precludes a systematic therapeutic     approach. Experimental evidence, including results from the animal models of cystitis and the     knock-out mice, indicate a participation of tachykinin receptors, especially the NK1R, in     neurogenic inflammation, which is considered an important element of the IC complex. However,     there is very scant information about the molecular mechanisms of IC in humans, or of the     types of receptors, which participate in neurogenic inflammation. Based on our molecular     biological know-how and the clinical expertise, we propose to investigate the role of the     tachykinin and bradykinin receptors and their signalling partners in CPPS and bladder     dysfunction in humans.   "
223427|NCT00775294|"     This study is being conducted to look at how the body handles the drug maraviroc. It will     measure the amount of maraviroc in blood, semen, saliva and in the rectum of men. The aim is     to understand how much of the drug (taken by mouth) reaches the oral, reproductive and     intestinal tracts. It is believed that the presence of this drug in these areas may be     beneficial in preventing the AIDS virus (HIV) from being passed from one person to another.     The study will take samples of blood, saliva, semen and rectal mucosal tissue to measure drug     levels. This study will also collect information on side effects.   "
223428|NCT00775307|"     The aim of this study is to evaluate the efficacy and safety of pazopanib compared with     placebo in patients with T < or = 5 cm, N0 (stage I according to TNM 2009) completely     resected NSCLC.   "
223429|NCT00775320|"     The primary objective of this study is to detect and quantify tumor cells of high grade     malignant gliomas and metastatic brain lesions both before and after initial surgical     resection in a cohort of newly diagnosed patients.   "
223430|NCT00775333|"     The aim of this study is in a prospective, consecutive series of diabetic patients with     carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having     idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel     release.   "
223431|NCT00775346|"     A multi-center, prospective, single-visit study designed to acquire physiologic pulse     oximeter waveform data during standard polysomnography (PSG) studies performed at multiple     different Sleep Lab Centers.   "
223432|NCT00775359|"     The objective of this study was to compare the single-dose relative bioavailability of     Ranbaxy and Abbott (TriCor) 160 mg fenofibrate tablets under fed conditions.   "
223433|NCT00775372|"     To compare the single-dose oral bioavailability of clarithromycin 250 mg/5 mL powder for oral     suspension of Ranbaxy Laboratories with Biaxin 250 mg/5 mL granules for oral suspension in     healthy, adult, human, male subjects under fed conditions   "
223434|NCT00775385|"     Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels     and EGFR mutations would attain better disease free survival rates than patients in the     control arm receiving noncustomized therapy. Using this selective approach, patients with     stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive     cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based     chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.      The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will     enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous     cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and     favorable toxicity profile and is of potential interest in the adjuvant setting of resected     non-squamous NSCLC.   "
223435|NCT00775398|"     The purpose of this study is to assess the effect of possible exposure to THROMBIN JMI® on     activated partial thromboplastin time (aPTT) at 48 hours post surgery in subjects with     likelihood of prior exposure to THROMBIN JMI® within the past 4 years.   "
223436|NCT00775411|"     The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as     adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with     choroidal neovascularization secondary to age-related macular degeneration. Subjects will be     followed for 26 weeks.   "
223452|NCT00775450|"     This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone     revaccination in elderly adults aged ≥ 65 years.      Primary Objective:      To describe the safety profile for all subjects.      Secondary Objective:      To describe immunogenicity 28 days following revaccination with one of three Fluzone     formulations.   "
223437|NCT00775424|"     A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of     PENNVAX-B with or without co-administration of constructs containing DNA encoding for the     expression of either IL-12 or IL-15.      Primary objectives        1. To determine the safety of HIV-1 DNA constructs (PENNVAX-B).        2. To determine the safety and optimal doses of the IL-12 and the IL-15 adjuvant constructs          when given with PENNVAX-B.      Secondary objectives        1. To compare the various vaccine groups for their immunological responses to several HIV-1          antigens, utilizing the ELISPOT assay.        2. To analyze antibody responses to the vaccine antigens over time.        3. To measure CD8 cell proliferative responses to vaccine antigens over time.   "
223440|NCT00769834|"     Papilledema is defined as swelling of the optic nerves often due to increased intracranial     pressure. When present, it often indicates life-threatening lesions of the brain such as     tumors, abscesses, meningitis, encephalitis, venous sinus obstruction or intracranial     hemorrhage. A similar clinical picture can also be caused by other conditions such as     malignant hypertension, diabetic papillopathy and uremia. When the intracranial pressure is     elevated in the absence of any known cause then it is called Idiopathic Intracranial     Hypertension (IIH). Untreated papilledema can cause progressive optic nerve damage and     blindness.      Patients with chronic kidney disease have a number of co-morbidities and thus are at an     increased risk for developing papilledema. Although clinicians have observed that patients     with kidney diseases have increased incidence of papilledema (unpublished data by Corbett et     al), there have been no studies on this subject to date. We believe that a higher incidence     of papilledema is found in patients with kidney diseases and this study could provide     evidence to suggest routine ophthalmic screening in this patient group.      Hypothesis: The prevalence of optic disc swelling is increased in patients with chronic     kidney disease.      Purpose: To establish the prevalence of disc edema in patients with chronic kidney disease.   "
223441|NCT00769847|"     This is a prospective study to evaluate outcomes in patients undergoing endoscopic     craniectomy for isolated, single-suture craniosynostosis.   "
223442|NCT00769860|"     Inclusion body myositis (IBM) is the most common progressive and debilitating muscle disease     beginning in persons over 50 years of age. This study will assess the safety and tolerability     of Arimoclomol in IBM as compared to placebo over 4 months of treatment.   "
223443|NCT00769873|"     Splenic/portal vein thrombosis is an alarming complication of splenectomy. Retrospective     studies in the literature have shown the incidence of symptomatic splenic/portal vein     thrombosis to be between 0.7% (Rattner et al., 1993) to 8% (Winslow et al., 2002). This is a     single-center, prospective, randomized study in subjects undergoing laparoscopic splenectomy.     All participants will receive one dose of pre-operative low molecular weight heparin     (Lovenox®) subcutaneously, 2 hours prior to surgery. Participants will be randomized     pre-operatively to treatment or control group however the treatment allocation will not be     revealed until the surgery is complete. Postoperatively, those assigned to the treatment     group will receive 40 mg of Lovenox® subcutaneously once a day for 21 days; those in the     control group will not. Patients with severe renal impairment will receive an adjusted dose     of Lovenox® (30 mg subcutaneous dose daily). All patients will have a baseline abdominal     Doppler ultrasound preoperatively and a second one done at 14 to 28 days post surgery to     monitor for the presence of portal vein and/or splenic vein thrombosis. They will also have     their lipase and liver function tests checked to correlate with the imaging findings.   "
223444|NCT00769886|"     The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline     ophthalmic solution compared to vehicle and its individual components in alleviating the     signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.   "
223445|NCT00769899|"     This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess     the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose     administration to healthy male Japanese volunteers.   "
223446|NCT00769912|"     To evaluate effectiveness of a prefixed 50% N2O- 50%O2 mixture in legal abortion under     paracervical block.   "
223447|NCT00769925|"     This study will compare the effectiveness of delivering cognitive behavioral therapy for     children with anxiety disorders through in-person contact versus through workbooks and     telephone communication.   "
223448|NCT00769938|"     The study will assess the hypothesis that the combination warfarin & clopidogrel 75 mg/day is     superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect     to bleeding complications while equally safe with respect to the prevention of thrombotic     complications in patients with both indications for warfarin use and dual antiplatelet     (clopidogrel 75mg/day + aspirin 80mg/day) treatment.   "
223449|NCT00769951|"     RATIONALE: Gathering information from older patients with newly diagnosed cancer may help     doctors learn more about the risks of functional decline.      PURPOSE: This studying is looking at the physical and mental health of older patients with     newly diagnosed cancer.   "
223450|NCT00769964|"     This is a first-in-human study of VA111913 TS, a new chemical entity being developed for the     treatment of dysmenorrhea. This study is designed to investigate determine the safety,     tolerability and pharmacokinetics of VA111913 TS after single and multiple doses in healthy     non-pregnant female volunteers of child bearing age.   "
223451|NCT00769990|"     RATIONALE: Genistein may increase the effectiveness of radiation therapy in treating pain     caused by bone metastases.      PURPOSE: This phase I/II trial is studying the side effects of genistein and to see how well     it works in treating patients undergoing external-beam radiation therapy for pain caused by     bone metastases.   "
223465|NCT00775619|"     The objective of this study was to compare the single-dose oral bioavailability of Carvedilol     12.5 mg tablets of Ranbaxy Laboratories with Coreg 12.5 mg tablets of Glaxosmithkline in     healthy, adult, human subjects under fed conditions.   "
223453|NCT00775463|"     This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release     tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil     diethanolamine is an analog of prostacyclin. Prostacyclin is a naturally occuring substance     produced by the cells of blood vessels that inhibits platelet aggregation, induces     vasodilation, and suppresses smooth muscle proliferation. Improvement in blood flow in lower     limbs and fingers would be anticipated to result in a reduction in ischemic pain, Raynaud's     phenomenon and promote healing of digital ulcers and other ischemic wounds.   "
223454|NCT00775476|"     Systemic lupus erythematosus (SLE) is a chronic inflammatory disease which often has     debilitating and potentially life-threatening consequences. The cause of SLE is unknown and     current therapies lack specificity and carry significant side-effects. Existing data in the     literature provide evidence that a natural antioxidant, glutathione, is depleted in T cells     of patients with SLE. This may be a key factor underlying abnormal activation and     predisposition of T lymphocytes to pro-inflammatory cell death via necrosis. Administration     of N-acetylcysteine (NAC), that serves as a precursor of glutathione (GSH), improves the     clinical outcome of murine lupus, and limits the toxicity of pro-oxidant/immunosuppressant     medications commonly used in patients with SLE. NAC is widely available in health food stores     and large doses (up to 8 g/day) can be safely administered to humans. In a one-year study of     patients with inflammatory lung disease treated with prednisone and azathioprine, addition of     NAC (1.8 g/day) diminished disease severity and reduced drug toxicity in comparison to     placebo. Moreover, oral NAC has been found to improve muscle fatigue which is reported to be     the most disabling symptom in 53% of patients with SLE. Thus, establishing a dose ranging     between 1.2-7.2 g/day that is well tolerated and capable of raising intracellular GSH in     lupus patients and determining its immunological and therapeutic impact in SLE appears to be     well justified.      The study will consist of two parts, Aim 1 and Aim 2.      AIM 1:      The purpose of Aim 1 was to establish the optimal daily oral dose of NAC that can be well     tolerated without side effects and can normalize or moderate the depletion of GSH in lupus T     cells.      36 SLE subjects and 42 healthy controls (matched by age and sex) were studied.      The 36 SLE subjects were divided into 3 groups of 12. Each group received a different dose of     NAC (N-acetylcysteine)or placebo as follows:      Group 1: 9 received 600mg of NAC two times a Day, 3 received placebo; Group 2: 9 received     1200mg of NAC two times a Day, 3 received placebo; Group 3: 9 received 2400mg of NAC two     times a Day, 3 received placebo;      To account for attrition 12 subjects were randomized in each group (9 active, 3 placebo).      At each subject visit, blood from a healthy donor was drawn and used as control. The control     blood was used for flow cytometry measurements of GSH and in vitro immunological studies. In     addition to GSH measurements and immunologic studies, routine labs., ASRS self-reporting     assessment questionnaire, and SLEDAI/BILAG/Fatigue scores were obtained for the SLE subjects.     The healthy control subjects also answered the ASRS self-reporting questionnaire. The ASRS     questionnaire was incorporated into the study procedures in October, 2009. It is designed to     assess a patient's ability to concentrate which could be affected by the involvement of the     Central Nervous System (CNS) in lupus. There were up to 5 study visits per SLE subjects in a     period of four months.      At each visit up to 100 ml of blood were drawn from each subject. 20 ml are needed for     routine labs. and up to 80 ml are needed for the GSH and immunological tests.      Dose comparisons were based on continuous monitoring of adverse events and drug tolerance.      AIM 2:      Aim 2 will determine the tolerance and impact of two NAC doses on disease activity and     prednisone use in 165 subjects with SLE in a double-blind placebo-controlled 12-month study.     It is designed to detect clinically meaningful differences in disease activity in the patient     population.      It was determined by statistical analysis that each group must have 55 subjects. SLE subjects     will be randomized into 3 groups of 55 subjects to receive 1.2 g of NAC twice a day, 2.4 g of     NAC twice a day, or placebo. There will be up to seven study visits per SLE subject,     including the screening and wash out visits. Visits 1-5 will be scheduled three months apart.     The study will last 13 months with the wash out visit. Each subject will donate approximately     80 ml of blood for research at each visit. Healthy control subjects will donate blood at the     same time. They will be matched to the SLE subjects by gender, age within 10 years, and     ethnicity. Their blood will be used as reference for research assays.      The inclusion and exclusion criteria will be the same as in Aim 1 and the same subjects may     continue to participate. There is a new consent form required to participate in the second     phase.   "
223455|NCT00775489|"     Patients that have consented to participate in the study will be randomly assigned to one of     two groups: control group or nasal steroid group. Patients in the control group will receive     normal saline inhaler. Patients in the study group will receive steroid inhaler Follow-up     visits are: baseline and weeks 2, 4, 6 after starting the spray. Intraocular pressure will be     recorded on all visits.   "
223493|NCT00776334|"     The objective of this study is to compare the relative bioavailability of fosinopril sodium     40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in     healthy adult subjects under fasting conditions.   "
223457|NCT00775515|"     Prostatitis is an inflammation of the prostate, an pelvic organ of men. Prostatitis can cause     great discomfort which varies but can include pelvic pain, pelvic pressure, a vague sense of     discomfort, a feeling of malaise and fatigue, fever, burning on urination, pain on reaching     orgasm, and bleeding.      In many men the symptoms of prostatitis can be chronic. It is estimated that in the United     States chronic prostatitis is responsible for as many as two million doctor visits a year.     The disease can be ruinous, interfering with work, intimacy, and other things.      The causes of chronic prostatitis are not understood. The treatments commonly used, including     antibiotics and prostate massage, work poorly. We now have evidence that laparoscopic     prostatectomy can eliminate the misery of chronic prostatitis. This trial aims to quantify     and better characterize the effect of laparoscopic prostatectomy on the symptoms of chronic     prostatitis.   "
223458|NCT00775528|"     This study will assess the safety and tolerability of pancrelipase delayed release capsules     in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic     Fibrosis.   "
223459|NCT00775541|"     The purpose of this study is to use an MRI exam to measure the concentrations of glutathione     (GSH) and Vitamin C (Asc) in the brains of normal healthy persons and type 2 diabetic     persons. The study will look at the relationship between chronic hyperglycemia and the levels     of these naturally occurring chemicals in the brain.   "
223460|NCT00775554|"     Will use visual analog scales to compare effectiveness of traditional hematoma block vs     ultrasound guided hematoma block with regards to pain. This will be done for closed forearm     fractures.   "
223461|NCT00775567|"     Fructose is the principal carbohydrate in fruits and is added to many food products. This 6     carbon sugar is associated with a number of ill effects, like promotion of high     triglycerides,precipitation of gout in men,possible depression in women and symptoms of     intolerance in a non ethnic dose dependent fashion.However, high fruit and vegetable intake     is associated with some epidemiologic evidence in prevention of some cancers like stomach and     colorectum.The principal protectors in these products are thought to be antioxidants and     other protective chemicals like polyphenols.In addition long chain polymers of     fructose:inulin are thought to help protect against cancer through prebiotic effects. In fact     poly-fructose molecules are used as prebiotic food supplements and are promoted as aids for a     healthy intestine with balanced microflora.      Polyfructose prebiotics induce some gastrointestinal symptoms of cramps gas bloating and     sometimes diarrhea.To date repeated consumption of these polyfructose molecules have not been     shown to induce colonic adaptation. Nor is there evidence that fructose intolerant people     adapt  to prolonged ingestion.      These findings are in contrast to findings with lactose intolerance where prolonged ingestion     leads to both symptomatic and physiological adaptation.In this interventional study we     evaluate whether fructose intolerant people can adapt to moderate dose daily fructose     ingestion.The desired outcome is symptomatic, physiological and colonic microfloral     adaptation. A failure to detect an increase in bifidobacteria on retesting may suggest that     in humans like in some other mammals GLUT5 fructose transport could be induced.   "
223462|NCT00775580|"     The purpose of this study was to determine the bioequivalence of atenolol formulations after     administration of single doses to normal healthy subjects under fasted conditions. These data     were to be evaluated statistically to determine if the products meet bioequivalence criteria.   "
223463|NCT00775593|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving clofarabine together with     temsirolimus works in treating older patients with relapsed or refractory acute myeloid     leukemia.   "
223464|NCT00775606|"     The ideal anti-HIV medications for patients with advanced HIV disease is unknown. There is     evidence that anti-HIV regimens that contain protease inhibitors can enhance immune function     better than regimens that do not contain protease inhibitors. This is a study that will     determine the difference in immune enhancement capabilities between an anti-HIV regimen that     contains the protease inhibitor - lopinavir-ritonavir, and a regimen that contains efavirenz.     Both medications are recommended as first line treatments for HIV-infected patients. This     study will recruit HIV-positive patients that need to start anti-HIV treatment because their     CD4+ T-cells are below 200. The usual threshold for starting treatment is a CD4+ T-cell less     than 350. Subjects will be randomized to treatment with either an anti-HIV regimen that     contains lopinavir-ritonavir or a regimen that contains efavirenz. The study will determine     the difference in immune reconstitution over 24 weeks of treatment with study medications.     Among the immune parameters that will be measured is the ability of each subject to respond     to vaccination with the tetanus-diphtheria vaccine and the 23-valent pneumococcal vaccine.     Both vaccines are also recommended for HIV-positive patients but HIV-positive patients tend     to have a lower response rate to these vaccines.   "
223466|NCT00775632|"     Graft versus host disease (GVHD) is one of the common complications after stem cell     transplant. This is a complication, which happens when the new stem cells from the donor     attack other cells in the body of the transplant recipient.      Recently, an antibody (protein) called alemtuzumab or Campath has been found to be effective     in the prevention of Graft vs. Host Disease.      Previous studies have shown a low risk of GVHD with alemtuzumab, however the risk of disease     recurrence was high. Previous studies have used a high dose of alemtuzumab. The purpose of     this study is:        -  To find if by lowering the dose of alemtuzumab, can serious GVHD be prevented without          increasing the risk of relapse (your condition getting worse).        -  To find whether low dose of alemtuzumab in combination with cyclosporine can prevent          GVHD more effectively when compared to current standard of care and does not increase          the risk of recurrence.   "
223467|NCT00775645|"     RATIONALE: Acetyl-L-carnitine may prevent or lessen neuropathy caused by chemotherapy. It is     not yet known whether acetyl-L-carnitine is more effective than a placebo in preventing     neuropathy caused by chemotherapy.      PURPOSE: This randomized phase III trial is studying acetyl-L-carnitine to see how well it     works compared with a placebo in preventing neuropathy in women with stage I, stage II, or     stage III breast cancer undergoing chemotherapy.   "
223468|NCT00775658|"     Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test     reactivity.   "
223470|NCT00775684|"     This study evaluates exenatide, sitagliptin, and glimepiride for the treatment of high blood     sugar in patients with impaired fasting glucose or early type 2 diabetes. The purpose of this     study is to determine if exenatide and sitagliptin increase the amount of insulin made by the     pancreas compared to glimepiride. It is hypothesized that exenatide or sitagliptin will     sustain or increase the amount of insulin made by the pancreas in comparison to glimepiride.   "
223471|NCT00775697|"     In this study children with recurrent wheezing (>/= 2 episodes in the last 6 months)and aged     less than 2 years will be enrolled as outpatients. They will undergo lung function evaluation     by Rint and by assessment of the flow curves at baseline and after 4 weeks of treatment with     Montelukast 4 mg/day. Symptom dairies will be filled by parents during the study period.   "
223472|NCT00775710|"     The purpose of the study is to determine the optimal method to withdraw non-invasive     ventilation after an episode of hypercapnic respiratory failure.   "
223473|NCT00775723|"     Objective: Melatonin production is known to be delayed in preterm-born infants up to 6 months     of age. This might be related to exposure of preterm infants to continuous lighting in the     NICU during a critical period of pineal gland development. The investigators aimed to test     the profile of melatonin production in these infants at 9-12 months of age.      Methods: Twenty three term-born and 23 preterm-born infants (gestational age: 29-34 weeks)     were studied. The investigators tested nocturnal urinary melatonin excretion, within a     repeated measures design, both at 9 and 12 months of age. Nocturnal urine was extracted from     diapers and urinary melatonin derivate (6-sulphatoxymelatonin) excretion was analyzed by     ELISA assay.   "
223474|NCT00775736|"     This study is conducted in Europe. The objective of this observational study is to evaluate     the number of serious side effects, when initiating NovoMix® treatment in patients with type     2 diabetes who previously used a human premix insulin under normal clinical practice   "
223475|NCT00775749|"     The purpose of this study is to see if the nicotine patch reduces post operative nausea     and/or vomiting (PONV) among non-smoking patients who are at high risk of PONV.   "
223476|NCT00775762|"     This is a monocentric, randomized, opened study to assess the anti-inflammatory and     anti-platelet effect of Clopidogrel and aspirin versus aspirin or clopidogrel alone in     patients with symptomatic polyvascular disease and with multiple recurrent cardiovascular     events.   "
223477|NCT00775775|"     This study will test if patients with moderate to severe traumatic brain injuries also have     endocrine abnormalities, examine any existing relationships among fatigue, depression and     endocrine abnormalities, and the relationship between endocrine abnormalities, quality of     life, and community integration.   "
223478|NCT00776126|"     Mammography remains the current standard in the detection of breast cancer. However,     conventional two-view mammography will not detect all cancers. The major limiting factor of     conventional mammography is the presence of superimposed breast tissue that can obscure     clinically significant lesions. It is this limitation that decreases the sensitivity of     mammography and leads to false negative results.      The recent development of digital detectors has allowed imaging technologies such as     tomosynthesis to become clinically feasible. The examination, similar to conventional     mammography with regard to patient positioning and glandular dose, allows acquisition of a     digital data set that can be reconstructed and viewed in multiple sections. The ability of     tomosynthesis to unmask overlapping structures has been shown in preliminary studies to     increase lesion visibility. Used as either a primary imaging modality, or as an adjunct to     screening mammography, tomosynthesis has the potential to provide increased sensitivity and a     lower number of false negative examinations.      The purpose of this study is to compare radiologist impression of digital breast     tomosynthesis to digital mammography with respect to their ability to see and characterize     specific lesion features.   "
223479|NCT00776139|"     An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover     bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories     Inc. (A subsidiary of Ranbaxy, Inc) with Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of     Pfizer Labs (Division of Pfizer Inc.) in healthy, adult, human subjects under fasting     condition   "
223507|NCT00776516|"     The objective of the study is to assess the PK, safety and tolerability of a single dose of     mirabegron alone and in combination with repeat doses of rifampin, a potent CYP3A4 inducer.   "
223608|NCT00777894|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. This may be an     effective treatment for liver cancer.      PURPOSE: This phase I/II trial is studying the side effects and best dose of external-beam     radiation therapy in treating patients with liver cancer that cannot be removed by surgery.   "
223609|NCT00777907|"     To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization     for the treatment of coilable wide-necked intracranial aneurysms   "
223480|NCT00776165|"     A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The     Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor     (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies.      Adult patients (18 years of age or older) diagnosed as having any malignancy (except myeloid     malignancy, ECOG status of 0-2 and having a history of experiencing neutropenia (absolute     neutrophil count < 1000/mm3) in a previous chemotherapy cycle and have one more cycle of     chemotherapy on the same drugs would be recruited into the study.      Treatment will be initiated not earlier than 24 hours after the administration of cytotoxic     chemotherapy in both groups.      Group 1: Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)(Shantha)        -  Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion          for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of          10,000/mm3 is reached whichever is earlier Group 2: Neupogen (rhG-CSF)        -  Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion          for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of          10,000/mm3 is reached whichever is earlier Primary End Point would be to evaluate the          percentage of patients developing febrile neutropenia (defined as body temperature ≥          38.2°C or developing a temperature of > 38°C twice in a 12-hour period and absolute          neutrophil count < 0.5 x 109/L on the same day of the fever or the day after)in the two          treatment groups.   "
223481|NCT00776178|"     Background:        -  Bladder cancer often recurs after treatment and patient survival varies greatly.        -  More knowledge is needed about factors that can help identify patients who are at          greater risk of disease recurrence and progression to minimize the need for screening          and to help guide treatment.        -  The New England Study of Environment and Health (NESEH), conducted by the departments of          health in Maine, New Hampshire and Vermont, the Dartmouth Medical School and the NIH,          examined the relationship between health and environmental factors such as smoking, diet          and water quality in New England. This study provides an opportunity to learn more about          patients with bladder cancer.        -  Before launching a full-scale follow-up study on bladder cancer, it is necessary to          determine the feasibility of obtaining needed follow-up information from patients          enrolled in the NESEH.      Objectives:      -To determine the completeness and quality of information about treatment, recurrence, and     progression that can be obtained for patients from their medical records.      Eligibility:      -Participants from the NESEH study who are residents of Maine and who were diagnosed with     bladder cancer between 2001 and 2003.      Design:        -  Determine the vital status of NESEH bladder cancer patients.        -  Select a sample of 40 living and 18 deceased patients.        -  Interview patients or their next of kin by telephone for about 30 to 45 minutes to          update exposure information, obtain names and addresses of all hospitals and physicians          they have seen since diagnosis, and obtain authorization to access medical records.        -  Obtain and abstract medical records.   "
223482|NCT00776191|"     The purpose of this study is to demonstrate an increase in protein metabolism during     treatment with Physioneal 35® (containing lactate 10 mmol/l, calcium 1.75 mmol/l) compared to     treatment with Physioneal 40® (containing lactate 15 mmol/l, calcium 1.25 mmol/l) in children     and adolescents with end stage renal failure receiving peritoneal dialysis.   "
223483|NCT00776204|"     The objective of this study is to evaluate the completeness of struts coverage and vessel     wall response to the new generation JACTAX drug-eluting stent vs Taxus stent in de novo     coronary artery lesions at 6 months post index procedure. To investigate the completeness of     the coverage as well as the number of uncovered stent struts per section, high resolution (~     10-15 µm axial) intracoronary Optical Coherence Tomography (OCT) will be used.   "
223484|NCT00776217|"     To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating     tablets of Ohm Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc., USA) with     Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc.,     USA in healthy, adult, human male subjects under fasting condition.   "
223485|NCT00776230|"     The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time     points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV     neutralizing antibodies at Day 56 after the first vaccination.   "
223486|NCT00776243|"     In type 2 diabetic patients, abnormality in secretion or action of incretin(GLP-1, GIP) is     observed. Although controversy still exists, the secretion of GLP-1 is thought to be reduced     by 20-30% while GIP secretion is normal or slightly elevated, in type 2 diabetic patients.     Various parameters such as the duration of diabetes, the amount of meal and their     constitution, gastric bypass surgery, and some antidiabetic drugs affect the secretion of     incretin. However, the secretion of GLP-1 and GIP in glucotoxic condition and whether they     recover after improvement of glycemic status is not known. The investigators aim to study the     effect of intensive insulin treatment in uncontrolled diabetic patients.   "
223487|NCT00776256|"     The effect of beta-glucan or fructo-oligosaccharide or their combination in bars on satiety     and food intake was tested by supplying these bars on two consecutive days.   "
223488|NCT00776269|"     In this clinical trial study,the investigators intend to compare two methods of trichiasis     treatment.One by argon laser and the other by radiofrequency then compare the result of these     procedures, especially, the investigators would like to compare which of these have less     complications such as bleeding,pain,notch in the site of surgery and etc.   "
223489|NCT00776282|"     To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating     tablets of Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, Inc. USA) with     Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc.,     USA in healthy, adult, human male subjects under fed condition.   "
223490|NCT00776295|"     The purpose of this study is to determine whether p53 vaccination followed by high dose     chemotherapy and autologous HCT and T cell therapy significantly induces immune responses     resulting in 1-year survival greater that the current 70%.   "
223627|NCT00778141|"     The objective of this study is to compare the relative bioavailability of metformin HC1 750     mg extended-release tablets (Ranbaxy) with that of Glucophage® XR 750 mg tablets (Bristol     Myers Squibb) in healthy, adult, subjects under non-fasting conditions.   "
227945|NCT00836043|"     This study will collect data on safety, effectiveness and patient acceptance of MabCampath     treatment under daily life conditions.   "
223491|NCT00776308|"     Conventional mammography is not a reliable method for determining the extent of disease in     women with breast cancer. Molecular Breast Imaging (MBI) is a new nuclear medicine technique     that allows the breast to be imaged in a manner similar to mammography, but without the pain     of compression. Initial results with this method have shown it is very good at detecting     small breast cancers (~1/4 inch).      The purpose of this study is to see if MBI is a better method than mammography in determining     how much cancer is present before a woman goes to surgery.      The study will comprise 120 women with breast cancer who are going to surgery. The     investigators hope that this study will demonstrate that MBI will be more accurate in     determining how much cancer is present.   "
223492|NCT00776321|"     Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in     the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has     in a clinical 2-weeks studies demonstrated pronounced reduction of independent risk factors     for the development of atherosclerotic cardiovascular diseases.      The purpose of the study is to assess the efficacy and safety of KB2115 as monotherapy     following 12 weeks of exposure compared to placebo. The aim of the study is to assess     efficacy (LDL-cholesterol lowering effects) and safety of KB2115.   "
223494|NCT00776347|"     The purpose of this study is to evaluate change of cerebral glucose metabolism by donepezil     therapy and to associate change of glucose metabolism and symptoms.   "
223497|NCT00776386|"     This study has two purposes. First, the investigators will identify determinants of changes     in motor ability, activities of daily living, and HRQOL after distributed Constraint-induced     therapy for patients with stroke with the Chi-squared Automatic Interaction Detector (CHAID)     analysis. The results will help target which types/characteristics of patients will benefit     most from the intervention and may identify different determinants across different levels of     outcomes. Secondly, in order to understand the extent of treatment effect in terms of     clinical relevance, the investigators will examine whether the change scores on measures of     motor ability, activities of daily living, and HRQOL after distributed CIT reach clinically     important differences or not.   "
223498|NCT00776399|"     Lung metastasectomy is the only therapeutic option to provide a long-survival in patients     with colorectal lung metastases. Recent studies have shown that radiofrequency (RF) ablation     is a safe and useful therapeutic option for the treatment of unresectable lung metastases. In     this phase-II trial, clinical utility of lung RF ablation will be evaluated in patients with     resectable colorectal lung metastases.   "
223499|NCT00776412|"     This study will collect information about markers of inflammation, blood clotting and blood     vessel function in HIV-infected adults and healthy volunteers. Biomarkers are biological     indicators that have been associated with disease. Certain markers of inflammation, blood     clotting, and blood vessel function have been associated with risk of cardiovascular disease,     stroke and death. One marker, called D-dimer, is a breakdown product of blood clots that has     been associated with serious medical conditions, including deep vein thrombosis (formation of     a blood clot in a vein deep in the body) and pulmonary embolism (blockage in the pulmonary     artery that occurs when a blood clot from a vein breaks away, travels to the pulmonary artery     and lodges there). High D-dimer levels have also been associated with cardiovascular disease     and stroke risk. In a recent study of HIV-infected patients, higher D-dimer levels were     strongly correlated with risk of death from any cause. The significance of changes in D-dimer     and other biomarkers in HIV-infected adults is not well understood. This study will further     explore D-dimer and other biomarkers to try to better understand the relationships between     them and HIV infection.      Healthy volunteers and HIV-infected adults 18 years of age or older may be eligible for this     study. Two visits are involved, as follows:      Visit 1 (screening visit to determine eligibility)        -  Medical history and physical examination.        -  Blood tests for HIV infection, blood counts, liver and kidney function.        -  Pregnancy test for women who can become pregnant.      Visit 2        -  Blood tests for hepatitis B and C        -  Blood tests for markers of inflammation and blood clotting.        -  Blood test for genetic changes that influence blood clotting.      In some cases, visits 1 and 2 may be combined.      Optional additional visits (up to 8 visits over 3 years)        -  Additional blood draws for investigation of specific clinical or laboratory findings may          be requested.   "
223500|NCT00776425|"     This 2 arm study will investigate Quality of Life response in anemic participants with solid     and lymphoid malignancies, who are receiving concomitant chemotherapy. Participants with     solid and lymphoid malignancies will receive epoetin beta at a dose of 150 international     units per kilogram (IU/kg) three times weekly. Participants with lymphoid malignancies will     receive epoetin beta 30000 IU once weekly.   "
223501|NCT00776438|"     To further characterize the immune responses induced after an influenza vaccination performed     either via the ID or the IM routes in two clearly distinct populations.      Objectives:        -  To describe the immune response per age group and vaccine group after vaccination.        -  To describe the safety of the vaccines per age group and per vaccine group after          vaccination.   "
223502|NCT00776451|"     To demonstrate the ability of intermediate AMD subjects to follow the instructions for use     and properly operate on their own the Preview PHP in home use environment, after going     through training session.   "
223503|NCT00776464|"     A study to treat 4 toes at a time to eliminate Onychomycosis   "
223504|NCT00776477|"     Clopidogrel is a antiplatelet agent and is effective at reducing intimal hyperplasia in     animal models of thrombosis.Several large clinical trials have demonstrated that clopidogrel     with aspirin can reduce ischemic events and mortality in patients with atherosclerotic     disease,therefore the combination of two antiplatelets might be useful to prevent patients     received coronary artery bypass graft surgery from Saphenous vein graft disease. the aim of     this study is to estimate the safety and efficacy of clopidogrel and aspirin therapy versus     aspirin alone in patients after CABG.   "
223505|NCT00776490|"     The objective of this study is to compare the relative bioavailability of glimepiride 1 mg     tablets (manufactured by Ranbaxy Laboratories Limited) with that of AMARYL® 1 mg tablets     following a single oral dose (1 x 1 mg tablet) in healthy, adult subjects under fasting     conditions.   "
223506|NCT00776503|"     The purpose of this study is to determine the maximum tolerated duration and schedule of oral     VORINOSTAT in addition to low dose cytarabine in the treatment of Intermediate-2 and High     risk myelodysplastic syndromes.   "
223508|NCT00776529|"     AIM:      Strengthening and sensorimotor training (e.g with the aim to improve balance) are widely used     in rehabilitation. There is little knowledge about the best ways to combine strengthening and     sensorimotor training. Therefore, the investigators want to evaluate two types of     combinations in healthy participants.      Interventions:        -  Group A: 1.) warm-up; 2.) sensorimotor training; 3.) strength training (nine sessions in          four weeks)        -  Group B: 1.) warm-up; 2.) one strengthening exercise, followed by a sensorimotor          exercise, alternating (nine sessions in four weeks)      Tests (Before first training and after four weeks):        -  isokinetic test of knee extensors and flexors (60°/s; 120°/s; 180°/s; 240°/s.)        -  squat jumps and countermovement jumps        -  static balance test on an unstable underground (measured with accelerometer)        -  dynamic balance: star excursion balance test, (a) on stable ground, (b) on unstable          ground. Balance tests will be performed (c) in recovered state and (d) fatigue (i.e.          after a fatiguing exercise).      Hypotheses        1. Group B (alternating sensorimotor and strength exercises) will improve more in the          balance tests than Group A (sensorimotor first, strength afterwards).        2. Group B will improve more in the countermovement jump than Group A.        3. There will be no differences in the improvements in the strength, power and squat jump          tests between the two groups.   "
223509|NCT00776542|"     The purpose of this study was to determine the bioequivalence of Minocycline formulations     after administration of single doses to normal healthy subjects under fasted conditions.     These data were to be evaluated statistically to determine if the products meet     bioequivalence criteria.   "
223510|NCT00776555|"     The purpose of this study is to compare subjective drug liking using the Drug Rating     Questionnaire, subject version (DRQ-S), question 2 and pharmacokinetics of Vyvanse™ and     ADDERALL XR® when administered as an oral solution.      Hypothesis: DRQ-S, question 2 will show no difference between the two drugs   "
223511|NCT00776568|"     The purpose of this study is to determine that extracorporeal shock wave therapy (ESWT) is     safe and effective for the treatment of refractory angina pectoris.   "
223512|NCT00776581|"     Since 1999, labor pain control has being performed in China, and the initial time of     analgesia is at the cervix >= 2 cm. Meanwhile, American Society of Obstetrics & Gynecology     recommended that the labor analgesia with neuraxial block should be performed at the cervix     >= 4 cm in 2002. After that, the threshold has been revised to at least >= 2 cm in 2006 by     the Society. However, in China, the practice of labor analgesia with neuraxial block has     being performed for over seven years. Up until now, the practice has being experienced during     this ten-year period at the cervix around 1 cm. The investigators hypothesized that labor     pain control in different stages had different characteristics and had different influence on     patients short- and long-lasting outcomes. This study is mainly investigating different labor     analgesia procedures in different stages since the initiation of the practice in 1999, and     assessing their influence on the outcomes to display the trajectory of development of labor     analgesia in China of which might fit to the the whole process of the study of labor     analgesia throughout the world. All these were done by analyzing the data records since from     January 1999 to December 2008.   "
223513|NCT00776594|"     The purpose of this research study is to assess the efficacy of antiangiogenic therapy     (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of     minimal systemic disease (based on rising PSA without metastases).   "
223514|NCT00776607|"     Background: Latent autoimmune diabetes in adults [LADA] is a type 1 diabetes that is slowly     developing. This means many people are treated as having type 2 diabetes at diagnosis as they     are adults who are not immediately insulin dependent. LADA can be distinguished from type 2     diabetes by antibody tests. Patients who are antibody positive have an autoimmune reaction     which is similar to that of type 1 diabetes and is not found in type 2 diabetes. We would     like to examine the best way of treating LADA in the early phase of the conditions, with     tablets (similar to type 2 diabetes) or with insulin (similar to type 1 diabetes).      Methods/Design: This is an open parallel group prospective randomised trial. Participants     need to have a GAD antibody test results of 101 WHO units or more and a diagnosis of diabetes     not requiring insulin at diagnosis. Participants will need to have been diagnosed within 12     months and not treated with insulin at study entry. They will be randomised to receive either     insulin (NovoMix 30) or tablets (diet treated followed by metformin followed by glitazone     (with or without metformin) followed by insulin). Primary outcome assessment will be for     change in HbA1c and change in fasting C-peptide over 24 months. Secondary outcome measures     will include Quality of life, GAD antibody levels, adverse events, inflammatory markers,     insulin resistance, and markers of the metabolic syndrome.      Discussion: This study seeks the best treatment for early LADA in terms of maintaining     glycaemic control and maintaining natural insulin production.   "
223515|NCT00776620|"     The objective of this study is to compare the relative bioavailability of glimepiride 1 mg     tablets (manufactured by Ranbaxy Laboratories Limited) with that of AMARYL® 1 mg tablets     (following a single oral dose (1 x 1 mg tablet) in healthy, adult subjects under fed     conditions.   "
223516|NCT00776633|"     The investigators hypothesize that reducing the duration of clopidogrel therapy from 6 months     to 6 weeks after DES implantation is associated with improved clinical outcomes in patients     on ASA and an oral anticoagulant.   "
223517|NCT00776646|"     To compare the single-dose oral bioavailability of hydrochlorothiazide 50 mg tablet of Ohm     Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg     tablet of IVAX Pharmaceuticals, USA in healthy, adult, human, male subjects under fasting     condition   "
223518|NCT00776659|"     To generate the following data from patients with early breast cancer treated with Aromasin®     in the adjuvant setting in India.        -  Efficacy of the treatment with Aromasin®        -  Safety of the treatment with Aromasin®   "
223519|NCT00776672|"     The objective of this study is to compare the relative bioavailability of fosinopril sodium     40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in     healthy adult subjects under non-fasting conditions.   "
223628|NCT00778154|"     Patients who have received the appropriate number of years of alendronate or risedronate     therapy will be recruited. Each patient will have received baseline BMD measurements     performed at the spine and the hip by DXA. Each patient will receive tetracycline to label     the bone and then have a transiliac bone biopsy. One year later teh bone label and biopsy     procedure will be repeated.   "
223520|NCT00776685|"     Several personality factors have been shown to be associated with risk for alcohol and     substance misuse, and differentiate substance abusers based on clinical profile, treatment     response and susceptibility to other forms of mental illness. Personality-targeted     interventions have been found to have significant preventative effects on onset and growth of     drinking, binge-drinking and drinking problems in adolescents attending mainstream schools     (Conrod, Castellanos & Mackie, 2008). The interventions concurrently reduced     personality-specific emotional and behavioural problems (Castellanos & Conrod, 2006), and     prevented the onset and escalation of drug-use over a two-year period (Conrod,     Castellanos-Ryan & Strang, 2010). This cluster randomised controlled trial aims to examine     whether these results can be replicated when interventions are delivered by trained     educational professionals. In addition, the trial will evaluate the broader impact of the     programme on cigarette smoking, school attendance, academic achievement and school-wide     behaviours.   "
223521|NCT00776698|"     This single arm study will evaluate the feasibility of treatment with 2 dose levels of     Avastin in combination with concurrent thoracic radiation and chemotherapy in patients with     locally advanced unresectable non-squamous non-small cell lung cancer. Two cohorts of     patients will receive 3 cycles of Avastin treatment (7.5mg/kg and 15mg/kg iv every 3 weeks,     respectively), concurrently with thoracic radiation and chemotherapy (cisplatin and     etoposide). Once a preferred dose has been established, this dose will be applied to a 3rd     cohort, who will then receive maintenance treatment with Avastin as a single agent for 6     additional cycles. The anticipated time on study treatment is <3 months for cohorts 1 and 2,     and 3-12 months for cohort 3, and the target sample size is <100 individuals.   "
223563|NCT00777270|"     The best technique for this repair would be that which requires least time in realisation,     least consumption of material for the repair and that which produces less pain at short and     long-term permitting the resumption of intercourse quicker and with less pain thereby     requiring less necessity to take out the stitches and less frequency of re stitching. The     investigators research is looking for a technique for repairing the perineum more     advantageously.   "
223522|NCT00776711|"     Study Design:      This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and     immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. One     group will receive A/Indonesia/05/2005 (inactivated H5N1) vaccine as both prime and boost,     two groups will receive the VRC-AVIDNA036-00-VP (DNA) vaccine as prime with inactivated H5N1     boost but with different boost intervals, and one group will receive the DNA vaccine twice as     prime followed by H5N1 boost. The hypothesis is that these regimens will be safe for human     administration and will elicit antibody and T cell responses against the H5 protein. The     primary objectives are to evaluate the safety and tolerability of the investigational vaccine     regimens, at a dose of 4 mg for the DNA vaccine and 90 microgram for the inactivated H5N1, in     healthy adults. Secondary and exploratory objectives are related to the immunogenicity of the     study vaccine regimens.      Product Description:      The inactivated H5N1 vaccine is monovalent subunit virion vaccine, A/Indonesia/05/2005 clade     2, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA). Vaccine vials will be supplied at 90     microgram/0.5mL. The VRC-AVIDNA036-00-VP vaccine was developed and manufactured by VRC, NIAID     and is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a     CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each vaccination will be     administered intramuscularly (IM) in the deltoid muscle using needle and syringe for the H5N1     vaccine and the Biojector (Trademark) 2000 Needle-Free Injection Management System     (Biojector) for the DNA vaccine.      Subjects:      A total of 60 healthy adults, ages 18-60 years will be enrolled.      Study Plan:      Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four groups.     Subjects and clinicians will be blinded to group assignment until Day 0 following completion     of the enrollment. At the point of enrollment the randomly assigned regimen will become known     to subjects and clinicians. Subjects will receive either two or three injections on the     schedule shown in the schema. The protocol requires five clinic visits and two telephone     follow-up contacts for Groups 1, 2, and 3, and six clinic visits and three telephone     follow-up contacts for Group 4.   "
223523|NCT00776724|"     This is a multi-center randomized phase III trial. The purpose is to evaluate and compare the     pathological complete response (pCR) rates after neoadjuvant chemotherapy with tailored     chemotherapeutic regimens or standard chemotherapy for stage II/III breast cancer with tumor     size more than 2 cm.   "
223524|NCT00776737|"     This study will compare two tests for attention deficit disorder (ADD) - the Test of     Variables of Attention (TOVA) and the NIH Test of Attention - to see if they produce the same     results. There are a number of problems with existing tests for ADD. For example, TOVA, the     most commonly used test, operates only on older computers and has other problems as well.     Because of these problems, NIDCD developed the new NIH Test of Attention. This study will     determine if the new test is valid for ADD and how the performance on this test compares to     the performance on the TOVA in the general population.      Healthy volunteers between 6 and 60 years of age who have no problems with sight or hearing     and are not taking medication for ADD may be eligible for this study.      After a brief interview, participants take the first of the two study tests. On a second     visit, they take the other of the two tests. Both tests ask the subject to respond to things     they hear and see on a computer screen. Each test takes 30 to 45 minutes to complete. Some     participants are asked to take the NIH Test of Attention a second time, on a third visit.     Participants also take a 15- to 20-minute subtest of the Weschler Intelligence Test.   "
223525|NCT00776750|"     Disturbances of acquired immunity are considered to be responsible, at least partly, for the     high infection rate and inadequate response to vaccinations observed in hemodialysis (HD)     patients and renal transplant recipient (RTR). The present prospective trial aims at (a)     evaluating the immunogenicity of a standard influenza vaccine in HD and RTR patients and (b)     at identifying determinants of the immune response.   "
223526|NCT00776763|"     Aims of the trial: Establishing the profile of the growth factors and other mediators of     angiogenesis in different ocular fluids (aqueous humour, vitreous gel and ocular liquid in     vitrectomized eyes), in the 2 most frequent proliferative retinopathies - diabetic     proliferative retinopathy (PDR) and exudative age related macular degeneration (AMD).     Following up the dynamic of this profile before and after intravitreal administration of     Bevacizumab (Avastin) as an anti-VEGF blocker.      Materials: The research will be conducted on the following categories of patients groups:        -  nondiabetic patients without AMD or any other diagnosed proliferative ocular disease          (controls)        -  patients with age related macular degeneration (AMD groups) before and after          intravitreal injections with Avastin        -  diabetic patients with different types of diabetic retinopathy, before and after          intravitreal Avastin (diabetic groups) Methods: Samples from different ocular fluids          will be collected from each group of patients. 10 growth factors and other 10 cytokines          will be determined in the ocular fluids samples.      Results: The results from the biochemical measurements will be statistically interpreted in     order to obtain conclusions for the clinical practice.      Conclusions: The conclusions of this trial will be used exclusively for research publications     and communications, as well as for clinical practice.   "
223550|NCT00777101|"     This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib     and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced     breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and     extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also     compare the safety of the two regimens and to compare quality of life of patients taking the     two regimens.   "
223527|NCT00776776|"     Very little information is available about extremely obese (body mass index [BMI] > 40 kg/m2)     adolescents. The purpose of the Follow up of Adolescent Bariatric Surgery (FABS) study is to     collect information obtained during the clinical care of obese adolescents from all over the     country that can be used by researchers to study obesity, the complications of obesity, and     the outcomes of obesity treatment during adolescence. This information will be used to     describe the experience of the obese adolescent, including how obesity during adolescence and     its treatment impacts health and well-being. The information may also be used to study causes     of obesity, to determine the predictors of successful obesity treatment and for other obesity     related research. Because of the importance of understanding the outcome of obesity and     obesity treatments (surgical and non-surgical) on the patient over time, the data included in     the study will be collected before, during and after any treatments rendered. For those who     do not undergo a treatment which results in major weight change, it will be critical to     determine the natural history of adolescent severe obesity as the adolescent transitions into     adulthood. Finally, another important purpose of the FABS research study is to obtain     patients' consent to be contacted for possible participation in future research studies.      SPECIFIC AIMS:        1. To describe the natural history of morbid obesity among adolescents who seek treatment          for their obesity        2. To describe major outcomes following bariatric surgery in adolescents evaluated at 3, 6,          12, and annually for 10 years post-operatively and compare these to outcomes to patients          managed non-surgically        3. To organize a national cohort of severely obese adolescents who agree to be contacted in          the future for research studies   "
223562|NCT00777257|"     The purpose of this study was to evaluate the immunogenicity and safety of the concomitant     administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.      Primary Objective:      To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces     antibody responses that are similar to those observed when each vaccine is given separately.      Secondary Objective:      To compare the rates of injection site reactions at the Tdap injection site after Tdap and     Menactra® vaccines are administered concomitantly to the corresponding rates of reactions     when Tdap vaccine is administered alone.   "
243711|NCT01045759|"     We propose an observational study to assess the ability of intensivists to evaluate for deep     vein thrombosis using 2 point compression ultrasonography.   "
223528|NCT00776789|"     Aims and Objectives      Aim      To determine the effect of delivery room Skin To Skin contact on breast feeding behavior of     term neonates born by normal vaginal delivery at 36-48 hours.      Objectives Primary objective To determine the effect of delivery room Skin To Skin contact on     breast feeding behaviour of term neonates born by normal vaginal delivery, between 36-48     hours (as measured by Infant Breast Feeding Score) by video recording using a randomized     controlled design.      Secondary objectives To determine the effect of delivery room Skin to Skin contact on        1. Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA)        2. Weight at 48 hours as measured by digital infant weighing scale.        3. Maternal perception of breast milk output, breast consistency, infant's feeding and          activity at 36-48 hours as measured by a score graded as very satisfied, satisfied,          acceptable and not satisfied.        4. Number and duration of feeding sessions till 48 hrs according to the mother as assessed          at 48 hours        5. Breast feeding rates at 6 weeks measured at the time of vaccination at the time of visit          to the hospital for the same or as asked by telephonic conversation.      Hypothesis      Infants receiving skin to skin contact when compared with neonates not receiving it,     demonstrate better breast feeding behaviour.   "
223529|NCT00776802|"     Phase 1/2, open-label, dose-escalation study to assess the safety and tolerability of GCS-100     in combination with etoposide and dexamethasone in patients with relapsed or refractory     diffuse large B-cell lymphoma.   "
223530|NCT00776828|"     Objectives :        -  To evaluate the influence of concomitant use of cilostazol with aspirin and clopidogrel          on the composite cardiovascular adverse outcomes (cardiac death, myocardial infarction,          nonhemorrhagic stroke, target lesion revascularization) after drug-eluting stent          implantation      Study Design : Prospective, open label, two arm, randomized multicenter trial to test the     superiority of cilostazol group compared with the control group. Patients will be randomized     according to the use of cilostazol      Patient Enrollment: 960 patients enrolled at 5 centers in Korea      Patient Follow-up : Clinical follow-up will occur at 1, 3 and 6 months. Angiographic     follow-up will be recommended to all patient at 6 months after index procedure.      Primary Endpoint        -  Composite of adverse cardiovascular/cerebrovascular outcomes (cardiac death, myocardial          infarction, nonhemorrhagic stroke, target lesion revascularization) within 6 months      Secondary Endpoint        -  All cause of death, stent thrombosis, and each component of primary endpoint at six          months        -  PRU level measured at discharge after the index procedure and after six months      Safety Endpoint        -  Bleeding complications according to TIMI criteria        -  The incidence of drug discontinuation        -  Heart rate   "
223531|NCT00776841|"     A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose     Study of Aramchol in Healthy Male Volunteers.      Primary Objectives:        1. To assess and characterize the safety and tolerability of Aramchol in 16 healthy male          subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight,          mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses          (Part B)        2. To assess the pharmacokinetics of Aramchol at the administered doses   "
223532|NCT00776854|"     Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer   "
223533|NCT00776867|"     The purpose of this study is to test whether perifosine- a drug that inhibits the protein     AKT, and has had some success in the treatment of adult cancers- is safe and effective in     treating cancer. The investigators want to find out what effects, good and/or bad, it has on     the patient and the cancer. The investigators are testing different dose schedules of     perifosine and the patient will be asked to partake in one of the dose schedules.   "
223534|NCT00776880|"     American Society of Anesthesiologists (ASA) physical status scale has been used worldwide for     assessing the status of patients before operation. However, merely the value of ASA scale did     not give enough information of patients to determine their prognosis and improvement of     outcomes. Since 1948, World Health Organization (WHO) defined health as the state of complete     physical, mental and social well-being and not merely the absence of disease or infirmity.     Therefore, the investigators hypothesized that the ASA scale only was needed to be modified     and should be replaced by a comprehensive gauge to evaluate the status of patients in depth.     Based on this thought, the investigators used a new system, i.e., physical-psycho-social     (PPS) scale, to assess the overall state before surgical procedures.   "
223535|NCT00776906|"     The Advance® 18 PTX® Balloon Catheter study is a clinical trial to study the safety and     effectiveness of the Advance 18® PTX® Balloon Catheter in the treatment of lesions in the     superficial femoral artery and popliteal artery.   "
223536|NCT00776919|"     This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a     clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris   "
223573|NCT00777413|"     The purpose of this study was to determine the bioequivalence of Minocycline formulations     after administration of single doses to normal healthy subjects under fed conditions. These     data were to be evaluated statistically to determine if the products meet bioequivalence     criteria.   "
223660|NCT00778570|"     The purpose of this combined retrospective and prospective chart review analysis is to     investigate the safety, efficacy, and predictability obtained via Laser-Assisted In Situ     Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) over a wide range of refractive     errors      The working hypothesis is that there will be no difference in clinical outcomes between     patients treated with LASIK or ASA.   "
223561|NCT00777244|"     Study Rationale Adrenocortical carcinoma (ACC) is a very rare disease with a high risk of     relapse after radical surgery. The efficacy of adjuvant mitotane treatment is suggested by a     retrospective multicenter international study showing that postoperative mitotane treatment     was associated with a significant reduction of the risk of relapse and death. However, these     promising results need confirmation in a randomized prospective study. Caution should be     adopted particularly in patients with low risk of disease relapse, in whom the benefit of     therapy should be weighted against the side effects. Even if an adjuvant treatment seems     justified in patients at high risk of relapse, a randomised prospective study is needed to     assess whether such a treatment is efficacious in patients at low-intermediate risk.      The purpose of the present study is to determine whether adjuvant mitotane treatment is     effective in prolonging the disease free survival in patients with adrenocortical carcinoma     at low-intermediate risk of progression who underwent radical resection   "
223537|NCT00776932|"     Specific Aims: 1) To examine differences between AA and white patients with knee OA in     willingness to consider knee joint replacement. 2) To examine the relationship between     socio-cultural factors and patient willingness to consider joint replacement. 3) To examine     how demographic, socio-cultural, and clinical factors mediate the relationship between race     and patient willingness. 4) To examine the relationship between patient willingness and     referral to orthopedic care for knee OA (secondary aim).      Experimental design/Methodology: A cross-sectional survey study design will be used to     examine socio-cultural and clinical factors that may vary by race/ethnicity and may be     determinants of willingness to consider joint replacement as a treatment option. Patients     with symptomatic and radiographic knee OA from the primary care clinics will be surveyed.     Only individuals with knee OA of sufficient severity that would be considered candidates for     joint replacement will be included. Analytic strategies include ordinal logistic regression,     path analysis, and regression trees.      Subject population: The study sample will consist of approximately 133 African American and     419 white patients with OA of the knee in a primary care setting.   "
223538|NCT00776945|"     Melanoma is a cutaneous malignancy that has the potential for local (skin) and regional     (lymph node) recurrence. These recurrences may be difficult to detect in their earliest     stages. We are attempting to use novel form of skin imaging that uses ultrasound combined     with laser to identify these recurrences early, when they may be most amenable to treatment.     This imaging will detect melanoma pigment below the surface of the skin and in the draining     lymph nodes, as well as new blood vessel formation that occurs with these loco-regional     metastases.   "
223539|NCT00776958|"     Goals of this registry:      1.1 To collect and store very limited demographic information (age, birthdate, race and     ethnicity), limited cancer risk and breast and ovarian disease history, as well as limited     family history of breast and ovarian cancer on patients who are at risk of breast or ovarian     cancer or who have had a diagnosis of either cancer,      1.2 To make available summary information (in an anonymous form) regarding the subjects in     this registry to Consortium members, and other investigators, who can use these data to plan     research projects and evaluate the feasibility of such projects,      1.3 To make available summary information (number of new patients seen in the clinic, number     of mutations, number of preventive surgeries, average age of patients seen) to the Lynne     Cohen Foundation for Ovarian Cancer Research, in order to document the numbers of subjects     who utilize their supported clinics.   "
223540|NCT00776971|"     Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation     leading to obesity development. Although drinks sweetened with aspartame are available the     anticipated positive effect of these drinks on obesity development has not been convincing.     However, the mechanisms linking drinks intake to obesity are yet to be clarified.      The investigators aim is to investigate the short-term effects of soft drinks     (sugar-sweetened and artificially sweetened (aspartame)), milk and water on the concentration     of circulating appetite-regulating hormones, the subjective sensations of hunger and satiety     (measured by visual analogue scales) and energy intake. The study is a crossover,     intervention trial with 24 overweight, healthy volunteers. The subjects will be tested on     four separate days for four hours. Each test day a preload drink (sugar-sweetened soft drink,     aspartame-sweetened soft drink, semi-skimmed milk or water) is served.      The investigators expect to clarify the mechanisms linking drinking habits to obesity     development and provide scientifically based nutritional guidelines.   "
223541|NCT00776984|"     The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate     the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to     placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined     as add-on controller therapy on top of usual care in patients with severe persistent asthma.     The primary objective of each trial is to evaluate the long term efficacy of tiotropium over     placebo on top of usual care in patients with severe persistent asthma as determined by     pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on     asthma control and health care resource utilisation. The secondary objective of each trial is     to compare the long term safety of tiotropium with placebo in this patient population.   "
223542|NCT00776997|"     The purpose of the study is to evaluate the safety and effectiveness of the LINX Reflux     Management System in the treatment of Gastroesophageal Reflux Disease (GERD).   "
223543|NCT00777010|"     Participants 60 and older with and without Parkinson's disease who have mild cognitive     decline will be randomized to either a standard higher carbohydrate diet or a     carbohydrate-restricted ketogenic diet for 8 weeks. The main hypothesis is that nutritional     ketosis will improve memory functioning. Pre and post-memory testing will be performed.     Subjects will also provide blood samples and a subset of subjects with receive magnetic     resonance brain imaging.   "
223544|NCT00777023|"     Depomed's Gabapentin Extended Release is an investigational, extended release formulation of     gabapentin that is being studied for the treatment of hot flashes in postmenopausal women   "
223545|NCT00777036|"     The purpose of this study is to determine whether dasatinib is safe and effective in children     and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+     acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after     imatinib or who are resistant or intolerant to imatinib. The side effects of this oral     investigational drug in children and adolescents will be evaluated   "
223546|NCT00777049|"     The purpose of the study is to assess the benefit of oral panobinostat monotherapy given to     women with HER2-negative locally recurrent or metastatic breast cancer.   "
223547|NCT00777062|"     To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension)     for the treatment of co-occurring cocaine and alcohol dependence   "
223548|NCT00777075|"     The purpose of the study is to determine whether the treatment with L-arginine leads to an     improvement of erectile dysfunction in patients with erectile dysfunction.   "
223549|NCT00777088|"     To determine the safety and effectiveness of Pipeline Embolization Device for the treatment     of uncoilable or failed wide-necked intracranial aneurysms.   "
223604|NCT00777829|"     This study will examine whether various drugs affecting sleep cycles can improve different     kinds of memory.   "
223605|NCT00777842|"     The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a     lesion in the coronary artery.   "
223551|NCT00777114|"     This will be a multi-center, Phase I, dose-escalation study of bortezomib in combination with     131I-tositumomab in patients with relapsed non-Hodgkin's lymphoma. Bortezomib will be     administered to patients twice weekly, with the first dose being given two days prior to the     treatment dose of 131I-tositumomab, and the second dose two days after RIT for a total of 5     doses.      Patients will be enrolled and undergo standard staging studies, including history, physical     examination, complete blood count, serum chemistries and LDH, TSH, HAMA, iliac crest bone     marrow biopsy, and CT scans of the chest, abdomen and pelvis. All patients will provide     written informed consent.      Bortezomib will be evaluated at 4 dose levels (0.30 mg/m2, 0.60 mg/m2, 0.90 mg/m2, and 1.2     mg/m2) and 131I-tositumomab at 2 dose levels (50 cGy and 75 cGy TBD). Bortezomib will be     administrated the day prior to 131I-tositumomab and twice weekly thereafter for 4 doses in     order to provide proteasome inhibition throughout the period of 131I-tositumomab activity.     The intention is to use 131I-tositumomab at full dose if possible. Therefore, the 50cGy dose     will be used only with the lowest dose of bortezomib in case of unexpected toxicities with     the combination.      Dose levels will be as follow:        1. 0.30mg/m2 bortezomib and 50cGy 131I-tositumomab,        2. 0.30 mg/m2 bortezomib and 75 cGy 131I-tositumomab,        3. 0.60 mg/m2 bortezomib and 75 cGy 131I-tositumomab,        4. 0.90 mg/m2 bortezomib and 75 cGy 131I-tositumomab, and        5. 1.2 mg/m2 bortezomib and 75 cGy 131I-tositumomab.   "
223552|NCT00777127|"     This clinical trial serves the purpose to compare the long-term effects of a treatment of     actinic keratosis - your skin disorder - using Aldara® 5% cream or Solaraze® 3% gel on the     face or the scalp. In particular, it should be found out whether the healing effect of these     two medications on the skin lesions (i.e. the damaged skin parts) can be maintained for a     prolonged period.   "
223553|NCT00777140|"     Iron overload has been associated with greater brain injury in ischemia/reperfusion     experimental stroke models and ischemic stroke patients, especially in those treated with     thrombolytic treatment. Deferoxamine administration, an iron chelator, offers a     neuroprotective action in ischemia/reperfusion animal models.      Primary objective: To evaluate the security and tolerability of deferoxamine endovenous     treatment in acute ischemic stroke patients treated with iv. tPA.      Secondary objectives: To study pharmacokinetics of deferoxamine given by endovenous bolus (10     mg/Kg) followed by 72-hour continuous intravenous infusion (20, 40 o 60 mg/Kg). To evaluate     the deferoxamine effect in clinical outcome, infarct volume and hemorrhagic transformation     and brain edema development.      Methodology: Double-blind, randomized, placebo controlled, dose-finding phase II clinical     trial. Study stages: 1st: bolus+20 mg/Kg/day vs. Placebo (n=15:5); 2nd: bolus+40 mg/Kg/day     vs. Placebo (n=15:5); 3rd: bolus+60 mg/Kg/day vs placebo (n=15:5). These doses will be     increased according to security results of the previous stage. Patients will be continuously     monitored in stroke units. Laboratory parameters will be measured at baseline, 24h, 72h and     30 days to evaluate adverse events related to the drug. Serum deferoxamine and feroxamine     concentrations will be measured along time after the injection in a subgroup of patients to     the pharmacokinetics study. CT scan will be performed at 24-36h to assess hemorrhagic     transformation and brain edema. The NIH Stroke Scale will be evaluated during     hospitalization, and the Rankin score at discharge and 3 months.      If deferoxamine demonstrate to be secure and well tolerated treatment in acute stroke     patients, it may be a new therapy option to lower the brain injury after ischemia and     reperfusion.   "
223554|NCT00777153|"     The purpose of this study is to see how effective cediranib is in treating a brain tumour     called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an     approved oral chemotherapy that belongs to the class of drugs called alkylating agents.     Cediranib is a new drug that has not yet been approved for this disease. This study will     compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo     (inactive substance) to see whether the combination or cediranib alone will be more     effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.   "
223555|NCT00777166|"     Oxytocin has cardio vascular effects as hypotension, tachycardia and possibly coronary spasm.     The uterotonic effect of the drug is used during cesarean section, to minimize blood loss.ECG     changes suggestive of cardiac ischemia (ST depression) has been showed in previous studies of     patients undergoing cesarean section i regional anaesthesia. The effect of oxytocin on this     outcome has not been investigated to any extent.      In the current study, we tested the hypothesis that there was no difference in occurrence of     ECG changes (ST segment depression) between two doses of oxytocin. Participants were     randomized to receive either 5 or 10 units of oxytocin in a double blinded fashion.      Main outcome measure is occurrence of significant ST depression on ECG. Secondary outcome     measures are mean arterial pressure, heart rate, blood loss, symptoms as chest pain,     shortness of breath and feeling of heaviness on the chest.   "
223556|NCT00777179|"     This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study     comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as     maintenance treatment in patients with locally advanced or metastatic NSCLC, who have     received and responded to prior platinum-doublet systemic chemotherapy. The primary objective     of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally     advanced or metastatic NSCLC patients with or without vandetanib maintenance.   "
223557|NCT00777192|"     The goal of this research study is to learn more about the pain and/or other symptoms that     patients may experience within five years from CRC diagnosis. Researchers also want to learn     how genetic differences may affect the symptoms patients experience from cancer and cancer     therapy.   "
223558|NCT00777205|"     We conducted a randomized controlled trial (RCT) that compared the effectiveness of a     telephone delivered, recovery focused, peer-support intervention to enhanced usual care for     VA patients with depression.   "
223559|NCT00777218|"     The purpose of this study is to determine if there are significant differences in the side     effects related to memory, repetition and recall among these three drugs when used in a     pediatric population.   "
223560|NCT00777231|"     The goal of this research study is to establish chimerism and avoid graft-versus-host disease     in patients with Hemoglobinopathies to halt disease progression.   "
223606|NCT00777855|"     The purpose of this study is to determine the importance of uptake drug transporters in the     drug disposition of warfarin. We predict that the elimination of warfarin will be decreased     when co-dosed with an inhibitor of uptake drug transporters.   "
223564|NCT00777296|"     A major factor in the respiratory health of CF subjects is acquisition of chronic Pseudomonas     aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18     years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin for Inhalation     (Arikayce™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate     encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and     delivery to the lungs of subjects infected via a nebulizer. Because liposome particles are     small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit     drug in close proximity to the bacterial colonies (Meers, et al., 2008) (Clancy, et al.,     2013), thus improving the bioavailability of amikacin at the infection site. The clinically     achievable doses of amikacin in the LAI formulation can effectively increase the half-life of     the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several     advantages over current therapies in treating CF subjects with chronic infection caused by P.     aeruginosa.   "
223565|NCT00777309|"     This is a randomized, placebo-controlled, double blind phase 2 study designed to compare     treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small     cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen     (other than erlotinib) for NSCLC.   "
223566|NCT00777322|"     The purpose of this study is to determine whether excimer laser corneal surface ablation     (T−Cat) can be safely combined with simultaneous corneal collagen cross−linking treatment to     produce an improved and stable corneal profile in the treatment of keratoconus.   "
223567|NCT00777335|"     The purpose of the study is to assess the benefit of panobinostat monotherapy given either     orally or i.v. to women with HER2-positive locally recurrent or metastatic breast cancer   "
223568|NCT00777348|"     This is a multicentre, randomised, double-blind, placebo-controlled, 4-way cross-over study.     At each study visit a standardised treadmill test will be performed to provoke EIA. Before     and after the challenge test pulmonary function variables (e.g. forced expiratory volume in     one second (FEV1)) will be measured in order to assess the protective effect of the study     medication.   "
223569|NCT00777361|"     This study is being performed in order to learn more about a new drug (possible as treatment     for people with Alzheimer's Disease and other conditions with cognitive dysfunction (memory     and attention problems)) and how it is handled by the body by giving the drug to healthy     volunteers with different genotypes.   "
223570|NCT00777374|"     Seasonal rhinoconjunctivitis or hay fever is a common atopic condition that is frequently     seen in clinical practice. Grass pollen is the major cause of pollinosis in many parts of the     world. Immunotherapy is the only treatment that may affect the natural course of allergic     diseases, and it may also prevent the development of asthma in patients with allergic     rhinitis. With conventional subcutaneous desensitization the duration of treatment is around     3-5 years and usually comprises around 30-100 allergen injections. As high allergen doses     have to be injected, allergic side effects may occur and patients must stay under medical     supervision for at least 1 hour. Transcutaneous immunization (TCI) is a needle -free     technique that delivers antigens and adjuvants to potent epicutaneous immune cells. The aim     of the new epicutaneous route of desensitization is to more specifically target the immune     system by loading Langerhans cells with the allergen. Lower antigen doses can be applied,     such that side effects are reduced.   "
223571|NCT00777387|"     Preservation of fertility is limited. Current methods include embryo cryopreservation and     while still experimental, ovarian cryopreservation. In single women who are at risk for     infertility secondary to cancer or couples who have ethical reasons to avoid embryo     cryopreservation, oocyte cryopreservation is an alternative Purpose of study is to compare     slow freeze to vitrification of human oocytes. Successful cryopreservation and subsequent     thawing programs are characterized by avoiding ice crystal formation.Vitrification, newer     alternative to slow freeze method, process by which water is prevented from forming ice.      Our hypothesis is that higher survival rate per oocyte is to be expected in the vitrification     group.   "
223572|NCT00777400|"     The purpose of this pilot trial is to determine whether a conversion from calcineurin     inhibitors (CNI) and mycophenolate mofetil (MMF) to a regimen consisting of efalizumab and     sirolimus is associated with an increase in T regulatory cells, white cells that control the     immune system and can prevent autoimmune diseases like arthritis or rejection of foreign     organs,and does not result in an increase in acute rejection.   "
223574|NCT00777426|"     A total of 60 participants will be enrolled. They will be in 3 groups        1. ARV-naïve, HIV-positive ≥ 20 year of age with HAD (n=25) who intend to start ARV        2. ARV-naïve, HIV-positive ≥ 20 year of age without HAD (n=25), who intend to start ARV        3. HIV-negative ≥ 20 year of age (n=10). The protocol team will work with the primary care          physician to ensure that the subjects receive standard HIV and ARV care; however,          initiation of ARV is not a requirement of the study and ARV will not be provided by the          study.      Participant accrual will include 10-15 participants per year. HIV-positive subjects will be     tentatively enrolled in HAD vs. non-HAD groups by the enrolling neurologist and subsequently     confirmed to that group by a consensus conference held every 6 months by the study     neurologists. In cases of disagreement, cases will be re-assigned to the consensus conference     determination and recruitment will continue. An external validation consensus conference will     be conducted as well every 6-12 months to monitor correct assignment of the level of     impairment.   "
223575|NCT00777439|"     The purpose of this study is to prescribe oral domperidone for subjects with gastrointestinal     disorders who have failed or suffered adverse effects from standard medical treatment.   "
223576|NCT00777452|"     to prospectively assess the health-related quality of life (HRQOL) changes during the first     year after different treatment modalities for localized prostate cancer.   "
223577|NCT00777465|"     The aim of this study was to apply the acute kidney injury criteria based on KDIGO     classification in a population of patients undergoing cardiac surgery [coronary artery bypass     grafting (CABG) or cardiac valve surgery (CVS)] and evaluate its impact as a predictor of     30-day mortality.   "
223578|NCT00777478|"     The primary objective of this Phase 1 study is to identify the recommended dose of capiri and     of sunitinib for combination therapy subsequent phase II trials.   "
234526|NCT00917423|"     This study will determine the importance and the level of physical activity among women with     anorexia nervosa, both during inpatient treatment and 1 year after hospital discharge.   "
223579|NCT00777491|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and gemcitabine, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Giving chemotherapy together with radiation therapy may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying two different chemotherapy and radiation     therapy regimens to see how they work in treating patients with stage II or stage III bladder     cancer that was removed by surgery.   "
223580|NCT00777504|"     The purpose of this study is to determine if and how often an unexpected fast increase of     disease and complaints shows after stopping the anti-angiogenetic therapy   "
223581|NCT00777517|"     To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg     commercial atorvastatin calcium tablet formulation.   "
223582|NCT00777530|"     The purpose of this study is to assess the safety and tolerability of ascending single oral     doses of bosutinib administered with multiple doses of ketoconazole and to provide the     pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole     and with food in healthy adult subjects.   "
223583|NCT00777543|"     The aim of the present study is to investigate the effect of pretreatment of bran on     improving the bioavailability of ferulic acid in wholegrain breads containing bran. As     secondary endpoints we will investigate the changes in plasmatic antioxidant capacity,     anti-inflammatory effects, colonic metabolites from ferulic acid and short chain fatty acids     (SCFA).   "
223584|NCT00777556|"     This is a non-comparative case series study to assess the ability of females 11-16 years of     age, inclusive, who are requesting emergency contraception (EC) to use the study product,     DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.   "
223585|NCT00777569|"     In this study, smokers will be randomly assigned to one of three conditions for six weeks: 1)     nicotine-free cigarettes (0.05mg); 2) extra low nicotine cigarettes (0.3 mg); or 3) medicinal     4 mg nicotine lozenge. The tobacco toxin profiles across these various products will be     compared. The effects of these products on biomarkers of exposure and risk factors for     disease, compensatory smoking, components of tobacco addiction and short-term smoking     cessation will be determined. Predictors of response to these products (e.g., compensatory     smoking, compliance with product use, time to lapse) will also be examined.      The following primary hypothesis will be tested: 1) Extent of tobacco toxin exposure will be     greatest for the extra low nicotine cigarette and least for nicotine lozenge. Other secondary     hypotheses include: 2) Compensatory smoking, as calculated by using cotinine, will be     greatest for the extra low cigarette compared to the nicotine-free cigarette; 3) Greater     positive subjective responses to cigarettes will be observed with extra low nicotine vs.     nicotine-free cigarette; 4) Similar withdrawal symptoms and negative affect will be observed     with nicotine-free cigarette and nicotine lozenge, and least withdrawal and negative affect     with the extra low nicotine cigarette; 6) Least dependence and greatest motivation and     self-efficacy to quit will be observed with nicotine lozenge and the greatest dependence and     least motivation and self-efficacy to quit with the extra low nicotine cigarette use; 7)     Shorter time to lapse will be observed with extra low nicotine vs. nicotine-free cigarettes     because of extinction is likely to occur with nicotine-free cigarettes, and the longest time     to lapse for nicotine lozenge because the cigarette condition groups will have experienced     stronger attentional bias toward cues, and more dependence prior to the quit date and greater     withdrawal after the quit date.   "
223586|NCT00777582|"     The purpose of this phase I randomised cross over study is to determine and compare the     bioavailability of two different oral formulations of AZD2281 in advanced solid tumour cancer     patients   "
223587|NCT00777595|"     The purpose of this study is to evaluate the effect of single doses of therapeutic and     supratherapeutic doses of inhaled CHF 4226 pMDI on ventricular repolarization in healthy     subjects compared with placebo.   "
223588|NCT00777608|"     This study will evaluate the performance of the CogState computerized neuropsychological     battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's     Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with     mild-to-moderate Alzheimer's disease (AD).   "
223589|NCT00777621|"     Weight loss induced by caloric restriction alone (CR) and by exercise alone (EX) result in     similar effects on blood glucose and insulin. The purpose of this study is to assess the     hypothesis that weight loss through caloric restriction plus exercise will result in greater     improvements on glucose tolerance and insulin action than similar weight losses through CR or     EX alone.   "
223590|NCT00777634|"     This study involves a 2.5 and 5 year follow-up interview for individuals who participated in     the initial family study of binge eating disorder. The study includes individuals with and     without eating disorder as well as their first degree relatives. As part of the study,     participants will be interviewed about their current psychiatric and medical symptoms, their     blood pressure will be measured, and laboratory specimens will be obtained.   "
223607|NCT00777868|"     The purpose of this study is to assess the safety and effectiveness of two concentrations of     IDP-108 in treating patients with onychomycosis   "
223758|NCT00781118|"     A prospective, randomized multicenter study of subjects with a high-risk of having a     myocardial infarction (MI) due to acute coronary syndrome or bypass surgery.   "
223591|NCT00777647|"     Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation     leading to obesity development. Although drinks sweetened with aspartame are available the     anticipated positive effect of these drinks on obesity development has not been convincing.     However, the mechanisms linking drinks intake to obesity are yet to be clarified.      The investigators aim is to investigate the long-term effects of intake of soft drinks, milk     and water. The study is a parallel, intervention trial with 80 overweight, healthy     volunteers. They will be randomly selected to drink one liter a day of one of the four drinks     for six months. The objectives are changes in numerous circulating metabolic risk factors,     changes in body weight, anthropometric data and fat distribution (measured by DEXA, MRI and     MR-spectroscopy).      The investigators expect to clarify the mechanisms linking drinking habits to obesity     development and provide scientifically based nutritional guidelines.   "
223592|NCT00777673|"     The purpose of this study is to determine how well this combination of chemotherapy drugs     works with bevacizumab in eliminating primary tumor in the breast prior to     surgery(pathological complete response or pCR in the breast). Bevacizumab is a drug that     works by blocking new blood vessel formation by the tumor cells. Giving chemotherapy and     bevacizumab before surgery may allow for lesser amount of breast tissue to be removed. To be     able to predict in the future which patients are more likely to get pCR to this drug     combination, specialized tests on tumor tissue will be performed.   "
223593|NCT00777686|"     The goal of this clinical research study is to learn if magnetic resonance imaging with     magnetic resonance spectroscopy (MRI/MRS scanning) can measure any extra growth in the     tumor that does not show up on regular MRI images. This study procedure will be performed on     patients with recurrent glioblastoma who are either being treated with chemotherapy that     blocks blood vessel growth, or will soon begin this type of chemotherapy.   "
223594|NCT00777699|"     The purpose of this study is to evaluate the safety and tolerability of XL765 in combination     with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that     inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been     shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas     inactivation of mTOR has been shown to inhibit the growth of tumor cells. Erlotinib is an     orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved     by the FDA as a single agent for the treatment of patients with locally advanced or     metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior     chemotherapy regimen and in combination with gemcitabine for first line treatment of patients     with locally advanced, unresectable or metastatic pancreatic cancer.   "
223595|NCT00777712|"     The overall aim of this research is to utilize wound derived inflammatory cells from diabetic     versus non diabetic human chronic wounds to understand mechanisms that are responsible for     disregulated inflammation in individuals with diabetes. Biology of normal (peripheral blood     derived cells) versus wound derived cells will also be studied.   "
223596|NCT00777725|"     This study will involve 70 patients who attend the Alfred Hospital with acute or chronic     heart failure as well as 30 age and gender matched control subjects. All participants will     have their history taking and a physical examination to detect symptoms and signs of heart     failure.      The main objectives are for determining the benefit and usefulness of Fibroscan (Liver scan)     in detecting liver stiffness (a condition caused by excess fluid build up in the liver which     has a negative impact on the livers ability to function properly) in heart failure patients     and for characterizing the incidence and severity of liver stiffness in this group of     patients.      After informed consent, a blood sample will be taken from all patients to assess their full     blood examination, glucose, lipid profiles, renal function and so on.      Then 24-48 hours after enrollment, the liver doctors will do the liver scan (Fibroscan) by     transient elastography. All the data are recorded and further analysis will be assessed.      In a small group of acute patients the blood tests and liver scan will be repeated just prior     to their discharge.      Optional Sub-study: For participants who consent to the optional sub-study another 20 ml of     blood for serum liver fibrotic markers will be collected.   "
223597|NCT00777738|"     This trial is designed to evaluate the efficacy and toxicity of Bortezomib , an inhibitor of     proteasome used in multiple myeloma, in patients with advanced Waldenström's     Macroglobulinemia disease.   "
223598|NCT00777751|"     The goal of this clinical research study is to learn if the radiation that you are receiving     will result in an increase in certain proteins produced by the heart called cardiac     biomarkers.   "
223599|NCT00777764|"     This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of     60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in     two successive cohorts of subjects, healthy volunteers and patients with allergic asthma     without prior exposure to omalizumab, according to a skin test protocol, consisting of a     prick skin test and/or intradermal test.   "
223600|NCT00777777|"     Prospective, multi-center, randomized, controlled (patients as their own control) trial on an     external mesh device (eSVS™, Kips Bay Medical) supporting saphenous vein grafts for coronary     bypass graft surgery in patients with multi-vessel coronary heart disease.   "
223601|NCT00777790|"     This study was designed to evaluate the antibody response to a Menactra® booster dose in     participants who previously received one dose of Menactra® or Menomune® as adolescents 3     years earlier in Study MTA02.      Primary Objective:      To evaluate the antibody responses to a booster dose of a tetravalent meningococcal     diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received     Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of     Menactra® in naive adolescents.   "
223602|NCT00777803|"     NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A     preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201     causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used     for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This     study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with     OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.   "
223603|NCT00777816|"     Study X052070 will evaluate the safety and pharmacokinetics (PK) of XOMA 052 administered to     patients with active, stable, moderate to severe rheumatoid arthritis (RA).      It is hypothesized that administration of XOMA 052 is likely to improve inflammatory control     in subjects with RA.   "
223610|NCT00777920|"     This Phase 3, international, multicenter, open-label study will monitor the long-term safety     of ambrisentan in adults with pulmonary hypertension. The available ambrisentan doses for     this study are 5 or 10 mg administered orally once daily; the approved doses of ambrisentan     in the United States, Canada, and the European Union are 5 and 10 mg. Investigators will be     able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose     adjustments is required. Participants receiving other therapies for pulmonary hypertension     that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in     this study and continue to receive such therapies. Participants enrolled in this study will     receive treatment with ambrisentan until such time as the investigator or participant chooses     to stop ambrisentan treatment, ambrisentan becomes commercially available, or the Sponsor     stops the study.   "
223611|NCT00777933|"     The use of steroids after kidney transplantation has been challenged because of variable     adverse effects which may increase the patient morbidity and mortality. The aim of this study     was to compare the safety and efficacy of immunosuppressive regimens consisting of     cyclosporine (CsA) and mycophenolate mofetil (MMF) or tacrolimus (TAC) and MMF after steroid     withdrawal 6 months after kidney transplantation in low-risk patients.   "
223612|NCT00777946|"     This study will assess the safety and efficacy of combination aliskiren/amlodipine in     patients not adequately controlled with aliskiren alone   "
223613|NCT00777959|"     This study will look to see if the combination of ridaforolimus and bicalutamide works better     than placebo and bicalutamide in men with prostate cancer.   "
224423|NCT00796003|"     The purpose of this study is to to determine the recommended dose level of JNJ-30979754     (decitabine) as well as to assess the safety and effectiveness in patients with     Myelodysplastic Syndrome (MDS).   "
223614|NCT00777972|"     The objective of this study was to compare the relative bioavailability of Fosinopril sodium     and hydrochlorothiazide 20-12.5 mg tablets by Ranbaxy Laboratories Limited with that of     Monopril ®.-HCT 20-12.5 mg tablets by Bristol-Meyers Squibb following a single oral dose (1 x     20-12.5 mg tablet) in healthy adult subjects under fasting conditions   "
223615|NCT00777985|"     The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal     continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference     treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.      The hypothesis is that blocking endothelin receptors with a drug will have the same systemic     blood pressure lowering effect than nCPAP in sleep apnea patients.   "
223616|NCT00777998|"     The present study will be a multicenter, prospective phase II-study investigating safety and     efficacy of the combination of auto-allo tandem stem cell transplantation in patients with     multiple myeloma and age of >_60 years, followed by maintenance therapy with low-dose     Thalidomide and Donor Lymphocyte Infusions.   "
223617|NCT00778011|"     Nausea and vomiting is a common complaint in the emergency department. Treatment is important     for many reasons. In addition to patient comfort, there are adverse effects secondary to     vomiting such as dehydration, metabolic alkalosis, Mallory-Weiss tears, and aspiration. Two     mediations common used for nausea in ED patients include Ondanesetron and Metoclopramide.   "
223618|NCT00778024|"     The objective of this study is to compare the relative bioavailability of fluoxetine HCL 40     mg capsules (by Ranbaxy Laboratories Limited) with that of PROZAC® 40 mg capsules (by Dista     Products Company) following a single oral dose (1 x 40 mg capsule) in healthy, adult subjects     under fasting conditions   "
223619|NCT00778037|"     To compare the single-dose oral bioavailability of Cyclobenzaprine hydrochloride 10 mg tablet     of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.) with Flexeril® 10 mg     tablet (containing Cyclobenzaprine hydrochloride 10 mg) of McNeil Consumer & Specialty     Pharmaceuticals, in healthy, adult, male, human subjects under fasting condition.   "
223620|NCT00778050|"     This study compared the relative bioavailability (rate and extent of absorption) of     amoxicillin tablets for oral suspension 600 mg by Ranbaxy Laboratories Limited with that of     Amoxil ® for oral suspension 400 mg/ 5 mL by SmithKline Beecham Pharmaceuticals following     single oral dose (600 mg) in healthy, adult, subjects under fasting conditions using a     randomized two-way crossover design.   "
223621|NCT00778063|"     The purpose of this study is to evaluate the use of intranasal dexmedetomidine to reduce the     incidence of emergence delirium during general sevoflurane anesthesia in a pediatric     population receiving pressure equalization tubes in one or more ear.   "
223622|NCT00778076|"     The purpose of this study is to determine the impact of a regular course of treatment with     Hyaluronic acid (HA) injections on gait in knee osteoarthritis (OA) patients. Three     consecutive HA injections will be compared to three consecutive placebo injections to     determine whether HA's analgesic effect is greater than that of a placebo injection, and to     observe whether HA's viscoelastic properties are manifested in a human knee OA population. We     hypothesize that HA injections will relieve pain to a greater extent than placebo injections     in knee OA patients, and will afford them with improved walking characteristics, such as     increased walking speed, and step length.   "
223623|NCT00778089|"     The purpose of this study is to assess the clinical utility of the ArteFill® pre-treatment     Skin Test in predicting and preventing hypersensitivity reactions to treatment with ArteFill®     implant   "
223624|NCT00778102|"     This 2 arm study will compare the resection rate of liver metastases and safety of surgery in     patients with metastatic colorectal cancer and primarily unresectable liver metastases     receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with     irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients     will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of     these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment     is until surgery, disease progression, unacceptable toxicity or patient refusal, and the     target sample size is <100 individuals.   "
223625|NCT00778115|"     The objective of this study is to compare the relative bioavailability of Loperamide HCl 2 mg     and simethicone 125 mg tablets (Ranbaxy) with that of Imodium® Advanced caplets (McNeil) in     healthy subjects under fasting condition   "
223626|NCT00778128|"     At step 1, patients with advanced solid tumors will receive CP-4126 capsules following a dose     escalation schedule until the maximum tolerated dose is reached. At step 2, 20 patients will     be randomized. They will receive at days 1 and 8 in a double cross design either oral CP-4126     at the recommended dose or gemcitabine 1000mg/m2 intravenously. At both steps, the schedule     of treatment will be day 1, 8, 15 q4w until complete response or disease worsening/     progressing. All further treatment at step 2 will be oral CP-4126.   "
223629|NCT00778167|"     This randomized phase I/II trial is studying the side effects and best dose of cixutumumab     and to see how well erlotinib hydrochloride works when given together with or without     cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer.     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. It is not yet known     whether erlotinib hydrochloride is more effective when given together with or without     cixutumumab in treating non-small cell lung cancer.   "
223630|NCT00778180|"     The purpose of this study was to evaluate the relative bioavailability of the test     formulation of furosemide 80 mg tablets (Ohm Laboratories, Inc.) with an already marketed     reference formulation Lasix® (furosemide) 80 mg tablets (Aventis Pharmaceuticals NJ) under     fasted conditions in healthy adult human subjects   "
223663|NCT00778609|"     The aim of the present study is to investigate whether women taking a new combined oral     contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone     withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle     compared to a commonly used contraceptive pill (Microgynon).   "
223710|NCT00780455|"     Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing     Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical     ability of patients with and without FRP.   "
223631|NCT00778193|"     Gastroduodenal ulcers are extremely common in the community today. Though much has been     written and observed concerning how ulcers form, not much has been described in the human     model concerning how these ulcers heal. As numerous patients already suffer from     gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the     treatment and management of these patients. The goal of this study is to investigate the     effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal     lesions in order to elucidate the mechanisms of ulcer healing. This single site,     single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer     healing through endoscopic, immunohistologic, and molecular PCR modalities.   "
223632|NCT00778206|"     The objective of this study is to evaluate the safety of long-term treatment with Kuvan.   "
223633|NCT00778219|"     60 patients, in three group of 20 patients each, scheduled for surgery needing general     anesthesia will be researched. Group A: tracheal intubation of single lumen tube using     laryngoscope. Group B: single lumen tube using lightwand. Group C: double lumen endobronchial     cath. During general anesthesia, the spectral power of heart rate variability at three     periods: (1) preoperation baseline (2) pre-intubation and (3) post-intubation will be     calculated and compared to investigate the autonomic stimulation effect of different tracheal     intubation methods.   "
223634|NCT00778232|"     This study compared the relative bioavailability (rate and extent of absorption) of     Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited with that of Neurontin ® 800 mg     tablets of Parke Davis Pharmaceuticals Ltd. Distributed by Parke-Davis, division of     Warner-Lambert Co. following a single oral dose (1x800 mg tablet) in healthy adult volunteers     under non-fasting conditions.   "
223635|NCT00778245|"     The objective of this study is to assess the single - dose relative bioavailability of     Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed     conditions.   "
223636|NCT00778258|"     The purpose of this study is to determine if children who are allergic to milk can increase     tolerance through frequent dose-escalation every 6 months versus 12 months leading to     eventual tolerance of less heated milk and ultimately unheated milk.   "
223637|NCT00778271|"     The objective of this study was to compare the single-dose relative bioavailability of     Ranbaxy and Parke-Davis (Neurontin®) 400 mg Gabapentin, following administration of a 400 mg     dose under fasting conditions   "
223638|NCT00778284|"     The objective of this study was to compare the single-dose relative bioavailability of     Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg     clavulnic acid (as the potassium salt) chewable tablet, following administration of 2 tablet     dose under fed conditions   "
223639|NCT00778297|"     This is a single blind, reference drug controlled, one center viral immunogenicity and     tolerability study of FluvalAB FL-K-004 Trivalent Influenza Vaccine with 6 μg HA/strain/dos     antigen content to assess immunogenicity and tolerability.      The aim of the study is to assess the immunogenicity and tolerability of FluvalAB FL-K-004     trivalent influenza vaccine with 6 μg HA/strain/dos antigen content (study drug) in age     groups 18-60 years and over 60 years, with the objective to verify efficacy and tolerability     of the study drug according to CPMP/BWP/214/96: Note for Guidance on Harmonization of     Requirements for Influenza Vaccines, 12 March 1997.   "
223640|NCT00778310|"     A number of brain regions have been down to be altered in both structure and function in     patients with ADHD, including prefrontal cortex, anterior cingulate, caudate and cerebellum.     Patients with ADHD often show reduced levels of activity in the frontal and cingulate regions     of brain while performing measures of inhibitory control during functional magnetic resonance     imaging (fMRI). While stimulant medications robustly improve the clinical symptoms of ADHD,     there are only a small number of studies examining the effects of these commonly prescribed     medications on brain activity. We propose to obtain fMRI in patients with ADHD on placebo and     on their individualized dose of OROS methylphenidate (Concerta). Our hypothesis is that     Concerta will increase the activity of the brain in the frontal, cingulate and amygdala of     the brain and that these brain changes will be associated with clinical improvement of     symptoms.   "
223641|NCT00778323|"     The purpose of this study is to assess whether a large clinical trial testing the effect of     RIPC on neurologic outcome in patients undergoing elective cervical decompression surge is     warranted.   "
223642|NCT00778336|"     This registry collects observational data about how mid-length AngioJet catheters (ie     XPEEDIOR and DVX models) are used in routine clinical practice.   "
223643|NCT00778349|"     To assess the food effect on pharmacokinetic profile of metformin liquid 100 mg/mL of Ranbaxy     Laboratories in healthy, adult, human subjecis following a dose administration of 10 mL (1000     mg) under fasting conditions, after a Iow fat meal and after a high fat meal   "
223661|NCT00778583|"     An open label, randomised, two-treatment, four-period, two-sequence, single-dose, crossover,     fully replicated bioavailability study on Nitrofurantoin formulations comparing     Nitrofurantoin 100 mg capsules of Ranbaxy Laboratories with Macrobid 100 mg capsules in     healthy, adult, human subjects under fed conditions   "
223678|NCT00778713|"     The objective of this study is to compare the relative bioavailability of Fosinopril sodium     and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited with that of     Monopril ® - HCT 20-12.5 mg tablets by Bristol Meyers Squibb following a single oral dose (1     x 20/12.5 mg tablet) in healthy adult subjects under non-fasting conditions.   "
223662|NCT00778596|"     Study purpose:      To investigate whether ALT rebound following corticosteroid priming enhances response to     telbivudine therapy.      Efficacy assessments:      The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without     prednisolone priming.      Data analysis:      A summary table will be presented as frequency tables for categorical variables as number,     and percentage, whereas descriptive tables for continuous variables as number, mean ± SD and     median (minimum, maximum). All statistical assessments will be two-sided and evaluated at     significance level of 0.05. Continuous variables will be analyzed using t-test, or ANOVA, and     categorical variables will be analyzed using chi-square or Fisher's exact test. A     non-parametric method, Wilcoxon rank-sum or sign-rank tests will be conducted for continuous,     and categorical variables if data is far from normal distribution.   "
234527|NCT00917436|"     To assess two regimens of thiocolchicoside injection and capsule in combination with either     diclofenac or ibuprofen in patients with acute low back pain.   "
223644|NCT00778362|"     The spleen may be removed due to benign hematologic disorders, such as idiopathic     thrombocytopenic purpura and hereditary spherocytosis, or malignancies, such as lymphomas and     leukemias. Splenectomy may also be performed due to splenic traumas or in association of some     surgical procedures, when combined splenectomy will make the operations easier. The most well     known procedure is distal pancreatectomy combined with splenectomy.      In this research, there are two main goals. Firstly, establish the data about the incidence     of overwhelming postsplenectomy infection (OPSI) in our country. Currently, the western data     of the incidence, morbidity rate and mortality rate of OPSI is well established and     vaccination along with prophylactic antibiotics is strongly recommended. Since the incidence     of OPSI in our country isn't clear, most (>95%) splenectomized patients in our hospital     (National Taiwan University Hospital) did not have vaccination or prophylactic antibiotics.     We'll try to determine the incidence of OPSI by reviewing of our hospital charts and by     structured interviews with patients.      The spleen is a phagocytic filter. So asplenic patients have higher risks of getting     infection and some spleen-preserving procedures are proposed. In our initial experiences,     distal pancreatectomy with splenic artery and vein divided could be safely performed and     greatly increased the possibility of preservation of spleen. However, when the spleen was     preserved with dividing the splenic artery and vein, the blood supply to the spleen will be     shifted from splenic artery to short gastric artery. Although a substantial immunologic     advantage exists if splenic tissue remains, this may not offer sufficient protection from     encapsulated bacteria if splenic arterial blood flow is reduced because experimental animal     studies have demonstrated that an intact splenic arterial system is necessary for optimal     control of infection. Thus, although the spleen is preserved in above mentioned procedure,     the function of the preserved spleen is questionable and has never been studied of. Our     second object is to determine the splenic function after after spleen-preserving distal     pancreatectomy with excision of splenic artery and vein by comparison of abdominal computed     tomography and immunological function of patients before and after operation. Besides, we'll     designed an animal experiment to examine the rate of pneumococcal clearance by the spleen and     to determine the relationship between splenic blood flow and splenic tissue mass in bacterial     clearance from the blood when the splenic vessels were divided.   "
223645|NCT00778375|"     The goal of this clinical research study is to learn if clofarabine given in combination with     cytarabine and decitabine can help to control the disease in patients with AML or MDS who are     60 years old or older. The safety of this treatment will also be studied.   "
223646|NCT00778388|"     The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and     tolerability.   "
223647|NCT00778401|"     This study compared the relative bioavailability (rate and extent of absorption) of the test     Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg     tablets of Parke Davis Pharmaceuticals Ltd., distributed by Parke Davis, division of     Warner-Lambert Co. in 28 healthy, adult subjects (21 males and 7 females) under fasting     conditions using randomized, two-way crossover design.   "
223648|NCT00778414|"     The objective of this study was to compare the rate and extent of absorption Ranbaxy     Laboratories Limited, India, amoxicillin - clavulanic acid and GlaxoSmithKline, U.S.A.     (Augmentin ES-600), amoxicillin - clavulanic acid, administered as a 1 x 5 mL (600 mg - 42.9     mg) oral suspension, under fasting conditions.   "
223649|NCT00778427|"     The objective of this study was to evaluate the relative bioavailability of the test     formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference     formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb     Company) under fasted conditions in healthy, male and female adult subjects.   "
223650|NCT00778440|"     Main objectives:        -  To know the distribution of risk elements of traffic injuries      Secondary objectives:        -  To study the distribution of risk elements related with the possibility of suffering          from a TI in relation to medication, chronic health problems, and consumption of          psychoactive substances (alcohol and others).        -  To know the relation between levels of perception of risk of suffering from a TI and the          presence of chronic problems, medications, or consumption of psychoactive substances.   "
223651|NCT00778453|"     The findings of this study will advance movement reorganization mechanism underlying     treatment approaches and clinical intervention techniques. These findings may inform     rehabilitation professionals about which treatment approach is superior to another one in     certain aspect of outcome and who can benefit most from certain treatment approach.     Accordingly, the results of this project may help us move quickly to design and develop     efficient and effective rehabilitation programs for individualized patients.   "
223652|NCT00778466|"     The objective of this study was to evaluate the relative bioavailability of the test     formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference     formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb     Company) under fed conditions in healthy, male and female adult subjects.   "
223653|NCT00778479|"     This study will examine the Performance of Sepraspray in Patients undergoing open abdominal     surgery      NOTE regarding reason for study termination:      A patient death reported during the trial warranted temporary suspension for review by the     independent data review committee. Although the committee recommended continuing enrollment,     enrollment was electively terminated by the sponsor.      A preliminary analysis did not identify any new risk that was not listed on the     investigational labeling for this product. A full analysis of the results is expected to     allow characterization of the risk/benefit and clinical utility of the product in the exposed     patient population.   "
223654|NCT00778492|"     Study Objective is to correlate the results of preoperative platelet mapping derived from     modified TEG with clinically significant postoperative bleeding and consumption of blood     products.   "
223655|NCT00778505|"     To compare manual administration of propofol and remifentanil and dual closed-loop using     bispectral index as the control variable during pediatric anesthesia   "
223656|NCT00778518|"     Study to find the optimal dose of Growth Hormone Replacement in young adult patients     suffering from childhood onset growth hormone deficiency (GHD).   "
223657|NCT00778531|"     The purpose of this post-approval study is to evaluate the continuing safety of ArteFill as     an injectable implant for correction of nasolabial folds over the course of five years post     implantation, with a focus on determining the incidence of granuloma formation. Incidence of     adverse events and subject satisfaction with respect to the subject's personal expectations     will be assessed.   "
223658|NCT00778544|"     The objective of this study was to compare the rate and extent of absorption of Ranbaxy     Laboratories Limited, India, Amoxicillin-Clavulanic acid and GlaxoSmithKline, U.S.A.     (Augmentin ES-600), amoxicillin-clavulanic acid, administered as a 1 x 5 mL (600 mg - 42.9     mg) oral suspension, under fed conditions.   "
223659|NCT00778557|"     The study was conducted as a blinded, randomized, 3-way crossover study to compare the     single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil     TM Powder for Oral Suspension (250 mg/5 mL) following one 5 mL dose under fasting conditions   "
223664|NCT00772837|"     Helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer     dyspepsia remain controversial . Many studies have examined the effect of H. pylori     eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive,     with as many studies yielding positive as negative results. Some studies have shown a     significant (although weak) symptomatic improvement after H. pylori eradication, and while     other yielding negative results. A recent Cochrane review has comprehensively demonstrated     that H.pylori eradication therapy has a small but statistically significant effect in     H.pylori positive non-ulcer dyspepsia. An economic model suggests this modest benefit may     still be cost effective . However it is difficult to reconcile these results in areas with     very high prevalence of H. pylori infection such as Pakistan since no such studies have been     conducted in developing countries.      The investigators hypothesize that eradication of Helicobacter pylori (H. pylori) leads to a     sustained improvement in symptoms of patients diagnosed with H. pylori associated functional     (non-ulcer) dyspepsia.   "
223665|NCT00772850|"     The purpose of this study is to investigate the potential insults of rotator cuff muscle and     the functional recovery of upper extremity function after antegrade nailing of humeral     fractures.   "
223666|NCT00772863|"     The purpose of this study is to assess the efficacy and the safety of the treatment.   "
223667|NCT00772876|"     This is a phase I study of a novel compound P1446A-05. Aim of this study is to identify the     the recommended phase II dose of the drug and to determine the nature of adverse effects     associated with the drug. P1446A-05 capsules will be given continuously (28 days in each 28     day cycle) to patients suffering from advanced malignancies with no effective treatment     available. The dose of the study agent will be lower i.e. 75 mg per day for initial patients.     If this dose is found safe, higher dose will be administered to next set of (three to six)     patients. This will continued till the safest and best dose is identified. Treatment will be     given for 4 cycles and continued further if found effective. Dose schedule may be modified to     introduce treatment holiday,if frequent adverse effects are seen on continuous     administration.   "
223668|NCT00772889|"     The purpose of this observer-blind clinical trial is to evaluate the safety and     immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly.     Subjects were previously vaccinated (NCT00529516).   "
223669|NCT00772902|"     This study investigated whether human immunodeficiency virus type 1 (HIV-1) infected subjects     with raised cholesterol switching their nucleoside reverse transcriptase inhibitor (NRTI)     backbone from Kivexa (Epzicom) to Truvada had an improvement in their fasting total     cholesterol after 12 weeks of treatment. The study also investigated whether any improvement     had a beneficial effect on the overall cardiovascular risk.   "
223670|NCT00772915|"     RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking     blood flow to the tumor.      PURPOSE: This phase II trial is studying how well lenalidomide works with or without     dexamethasone in treating patients with newly diagnosed multiple myeloma.   "
223671|NCT00772928|"     This study is designed to evaluate in a controlled manner the effect of Prevnar® on the     immune responses of Pentacel™      Primary Objective - Stage I:      To compare the immune responses elicited by an infant series of Pentacel™ when given at     different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).      Primary Objective - Stage II:      To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different     times from or concurrently with Prevnar®.   "
223672|NCT00778622|"     The purpose of this study is to investigate the effect of the baseline body mass index (BMI)     on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with     newly diagnosed type 2 diabetes   "
223673|NCT00778648|"     The primary objective of this study is to determine the effect of an encapsulated juice     powder concentrate on the number of days with at least moderate common cold symptoms over     winter time.   "
223674|NCT00778661|"     The objective of this study was to compare the single-dose relative bioavailability of     Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg     clavulnic acid (as the potassium salt) chewable tablet, following administration of 2 tablet     dose under fasting conditions   "
223675|NCT00778674|"     The purpose of this study was to determine the bioavailability of Benazepril and     hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration     of single doses to normal healthy subjects under fed conditions. These data were to be     evaluated statistically to determine if the products meet bioequivalence criteria.   "
223676|NCT00778687|"     Cirrhotic cardiomyopathy describes a hyperdynamic state with the presentation of high cardiac     output and low systemic vascular resistance. And the latent heart failure becomes obvious     under physiologic and pharmacologic stress. The goal of our study is to assess the effects of     liver transplantation on the heart rate variability in patients with end stage liver disease.   "
223677|NCT00778700|"     The study will be a double-blind, randomized, vehicle-controlled study with application of     INCB018424 phosphate cream or vehicle in patients with stable plaque psoriasis. Application     will be QD for 12 weeks without occlusive dressings. There will be 4 treatments of 50     subjects each.   "
223679|NCT00778726|"     The purpose of this study was to determine the bioavailability of benazepril and     hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration     of single doses to normal healthy fasted subjects. These data were to be evaluated     statistically to determine if the products meet bioequivalence criteria.   "
223680|NCT00778739|"     The study was conducted as an open-label, randomized, 2-way crossover study to compare the     single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil     TM Powder for Oral Suspension (250 mg/5 mL) following one 5 mL dose under fed conditions   "
223681|NCT00778752|"     This study is a Phase I (non-randomized) study evaluating three dose-levels of Lenalidomide     in patients after allogeneic stem cell transplantation, accomplished in two institutions     (University Medical Center Hamburg-Eppendorf/ University Medical Center Heidelberg).   "
223682|NCT00778765|"     To compare the single-dose oral bioavailability of metformin HCI liquid 500 mg/5 mL of     Ranbaxy with Glucophage® 1000 mg tablets of Bristol-Myers, USA following administration of a     1000 mg dose in healthy, adult, male and female volunteers under fasting conditions   "
223685|NCT00778804|"     The study will evaluate the impact of an internet based telemedicine system on cardiovascular     risk profile of underserved patient populations. It is our hypothesis that a treatment plan     and frequent communication via an internet based Telemedicine system will improve the     cardiovascular risk profile of underserved patient populations at increased risk for     cardiovascular disease. Our primary endpoint is a reduction over one year in the 10-year CVD     risk score (ATP III risk model).   "
223686|NCT00778817|"     This randomized phase II trial is studying mitotane and IMC-A12 to see how well they work     compared with mitotane alone in treating patients with recurrent, metastatic, or primary     adrenocortical cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as     mitotane, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as IMC-A12, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them. It is     not yet known whether mitotane is more effective with or without monoclonal antibody IMC-A12     in treating adrenocortical cancer.   "
223687|NCT00778830|"     This is an open-label, non-randomized, multicenter Phase II study evaluating folinic acid +     fluorouracil + irinotecan (FOLFIRI) plus cetuximab (Erbitux) or folinic acid + fluorouracil +     oxaliplatin (FOLFOX) plus cetuximab as first-line therapy of patients with KRAS wild-type     metastatic colorectal cancer.      Only subjects with k-ras oncogene (KRAS) wild-type tumors are eligible. Efficacy will be     assessed every 8 weeks. Treatment will be continued until progressive disease or unacceptable     adverse events occur. After the end of study treatment, information on further anticancer     treatment and survival will be collected every 3 months.   "
223688|NCT00778843|"     The pathogenesis of chronic hepatitis C (CHC) is associated to severe oxidative stress and     non-selective immunological disturbance that leads to necro-inflammation and progression of     fibrosis. Previous trials suggested that antioxidant and inmunostimulant therapies may have a     beneficial effect. The purpose of the study is to evaluate whether Viusid, a nutritional     supplement with hepatoprotective properties, could ameliorate the oxidative stress and     modulate the immune response in patients with CHC and non-responders to pegylated interferon     plus ribavirin, during 24 weeks of treatment.   "
223689|NCT00778856|"     Organ transplantation has become the treatment of choice for most patients suffering end     stage diseases of the kidney, pancreas, liver, heart or lung.      Vascularized Composite Allotransplantation (VCA) {a.k.a. composite tissue     allotransplantation} is the term used to describe transplantation of multiple tissues (skin,     muscle, bone, cartilage, nerve, tendon, vessel) as a functional unit (e.g. hand). Several     recent advances in clinical organ transplant immunosuppression and experimental limb VCA have     now made it feasible to consider clinical VCA for the functional restoration of patients with     loss of one or both hands.      This protocol facilitates the development of limb VCA at the Atlanta Veterans Affairs Medical     Center (VAMC) and at Emory University for patients with below the elbow amputations. It will     evaluate the patients' use of transplanted limb(s) in activities of daily living and compare     the function of the transplanted hand to the function with their previous prosthesis.      Patients with below the elbow amputations will be enrolled. Donor tissue will be recovered     from deceased donors following the guidelines of and in cooperation with the regional Organ     Procurement Organization. The transplantation procedure and postoperative care will be     performed using the standard technique for limb replantation. Patients will receive standard     immunosuppressive regimen. Rejections will be treated in keeping with experience from the     solid organ transplant experience. Graft failure will be treated with allograft amputation.   "
223690|NCT00778869|"     This is an open-label, controlled sub-study to the parent protocol (P04041, NCT00779935) to     examine the expression profile of genes in patients in the active stage of ankylosing     spondylitis (AS) compared to the healthy population as control, moreover to examine the     changes in expression profile during anti-tumor necrosis factor (TNF)-alpha treatment     (Remicade).   "
223691|NCT00778882|"     The purpose of this study is to evaluate the safety and efficacy of administration of     autologous hematopoietic stem cells transduced with MT-gp91 retroviral vector for patients     with X-linked chronic granulomatous disease.   "
223692|NCT00778895|"     Children younger than 5 years of age are at high risk for severe influenza disease (flu) and     hospitalization due to flu. Scientists are in the process of re-evaluating the dosing     initially based on whole virus vaccines to improve their efficacy in infants. In this study,     we will compare two different dose levels of GSK1557482A flu vaccine. Another already     approved flu vaccine made by a different company will be used as a control.   "
226604|NCT00818493|"     This is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in     patients who have undergone primary unilateral total knee arthroplasty or total hip     arthroplasty.   "
223693|NCT00778908|"     Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal     carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that     intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing     daily dose starting at the fifth week after initiation of IMRT might improve tumor control     and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The     study is designed to test if late-course accelerated hyperfractionated IMRT can improve the     outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with     locoregionally advanced nasopharyngeal carcinoma.   "
223694|NCT00778921|"     This study will assess the safety and efficacy of combination aliskiren/amlodipine in     patients with hypertension not adequately controlled with amlodipine alone.   "
223695|NCT00778934|"     The purpose of this study is to evaluate the effects of an intimate health product on sexual     experience in females.   "
223696|NCT00778947|"     The purpose of this single centre study is to evaluate whether the use of Harmonic Synergy     Dissecting Hook (Harmonic Scalpel) in breast reconstruction surgery is superior to     conventional diathermy in terms of improving ease and speed of perforator dissection,     reducing postoperative pain, days of hospital stay and time taken to return to daily     activities.   "
223697|NCT00778960|"     The purpose of this study is to find out how meditation influences certain systems in the     body: nervous system, hormonal system, and respiratory system. Another purpose is to see how     meditation may help improve post-traumatic stress disorder symptoms.   "
223698|NCT00780299|"     Rationale: Despite spontaneous cardiac activity recovery, a shock occurs in more than half of     patients after resuscitation for cardiac arrest. This acute circulatory insufficiency     presents similar characteristics with septic shock and is responsible of most early deaths.     Most frequently, usual treatments are unable to control this shock and to avoid the     appearance of multiple organ failure.      Aim of the study: In addition to conventional therapeutics, an early plasma epuration of     inflammatory mediators (HDHP) could be able to improve hemodynamic parameters and to reduce     the shock duration. This improvement could have an impact on multiple organ dysfunctions and     also on early mortality.   "
223699|NCT00780312|"     The purpose of this study is to investigate whether the extent of late sequelae     symptoms(reduced mouth opening, lymphoedema, decreased range of motion in the neck and     shoulder region, speech and swallow disorders and reduced facial expression) due to     radiotherapy treatment for head and neck cancer can be reduced by an individually adjusted     physiotherapy effort applied immediately after the onset of and during radiotherapy     treatment.   "
223700|NCT00780325|"     Cyclooxygenase-2 (COX-2) inhibitors have become a common analgesic treatment option for     patients with arthritis. However, long-term treatment has been associated with increased     cardiovascular risk. With the past withdrawals and rejections of approval for COX-2     inhibitors the treatment options are now very limited.      This translates for example to about 10 million osteoarthritis patients in the US who cannot     receive COX-2 inhibitors because of concomitant hypertension. And this exemplifies the unmet     medical need to develop and offer safe treatment options for this particular patient     population.      This trial investigates pharmacodynamic aspects of CG100649 which is being developed as a     novel COX-2 inhibitor. Preclinical data show a dual mechanism of action, which consists of     the inhibition of the two enzymes COX-2 and carbonic anhydrase-I/-II (CA-I/II) and through     which the cardiovascular risk of COX-2 inhibition might be attenuated.   "
223701|NCT00780338|"     Alcohol and other drug use among youth is costly for communities. More research is needed     about how to best support community based prevention programs and how community prevention     expertise can inform the research process. The National Institute on Drug Abuse has funded a     5 year collaboration of the RAND Corporation, Search Institute and its training division,     Vision Training Associates, Communities for Children and Youth, and the University of     Southern Maine to implement and assess the impact on prevention coalitions, the combination     of two complimentary, community-based interventions: Developmental Assets, which supports     community mobilization and collaboration to promote positive youth development, and Getting     To Outcomes (GTO), which enhances community capacity to complete critical prevention tasks     (e.g., evaluation). The purpose of the project is to investigate: 1) How well is the     Assets-GTO intervention delivered, how much is it used, and what coalitions think about it;     2) The extent to which the Assets-GTO approach enhances the prevention capacity (knowledge,     attitudes, and skills) of individual coalition members and the quality of prevention     performance; and 3) Whether enhanced prevention capacity improves alcohol and drug outcomes     among youth. Twelve community-based prevention coalitions in Maine (part of Communities for     Children and Youth) will participate. Six coalitions—determined at random—will receive     manuals, training, and on-site technical assistance consisting of bi-Weekly meetings between     A-GTO 4 ME! and key coalition staff. The other six coalitions will continue practice as     usual, but will receive an abbreviated version of the Assets-GTO intervention near the end of     the project. A Community Research Workgroup made of coalition representatives will review all     aspects of the study and interim findings and facilitate dissemination on A-GTO 4 ME! The     project will demonstrate and evaluate strategies to strengthen the prevention capacity of     community organizations that can be used broadly across many types of programs.   "
223702|NCT00780351|"     1. Sustained low efficiency daily hemodiafiltration(SLEDD-f) is a kind of renal replacement          therapy with high-flux dialyser membrane (helixone).        2. The pore size of helixone is larger than most antibiotics, and vancomycin is supposed to          be removed during dialysis.        3. Our study wants to find the amount of vancomycin removed during SLEDD-f, and try to find          the most appropriate dose regimen for this kind of patients.   "
223703|NCT00780364|"     The objective is to establish the effect of sour taste and cold temperature on the pharyngeal     swallowing transit time after ischemic hemisphere stroke.   "
223704|NCT00780377|"     Heart transplant recipients do not have nerves to their hearts. This protocol tests the     hypothesis that bradykinin mediated t-PA release in the coronary arteries will be reduced in     heart transplant recipients compared to healthy subjects.      This study will compare heart transplant recipients to healthy controls who are undergoing     cardiac cath for standard of care purposes (separate protocol) and compare the coronary     arteries to the forearm in transplant recipients (separate protocol) and healthy controls     (separate protocol).   "
223705|NCT00780390|"     To demonstrate that spinal cord stimulator has an effect on sympathetic function (the one     that give us the fight and flight response). Therefore, if the spinal cord stimulator has an     effect on sympathetic function, the responses from CRPS patients to different stimuli will     differ significantly pre and post SCS implant.      If CRPS patients exhibit autonomic, CRPS patients could be stratified according to their     sympathetic function pre-implant. It is expected that patients with a moderate/mild form of     autonomic dysfunction will have better outcomes with the SCS.   "
228811|NCT00848445|"     To evaluate whether atrial fibrillation (AF) therapies in Guidant Pulsar Max II or Insignia     Plus DR have an effect on the occurance of AF in patients with no prior history of AF   "
223706|NCT00780403|"     The primary objective of this study was to determine whether children ages 6-11 years prefer     desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The     secondary objectives of this study were to compare acceptance of the two attributes, taste     and feeling in the mouth, of desloratadine 2.5 mg RediTabs and Zyrtec® 5 mg Chewable Tablets   "
223707|NCT00780416|"     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b     (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.   "
223708|NCT00780429|"     Study of the pharmacokinetic and pharmacodynamic variability of mycophenolate mofetil in     renal transplant patients already on long-term MMF treatment (at least 6 months     post-transplant; at least 3 months in therapy).      Study hypothesis: to investigate whether long-term MMF therapy alters IMPDH biological     activity and if there are any correlations with the risk of AR.   "
223709|NCT00780442|"     In summary, this pilot study will explore the use of an innovative pharmacologic approach to     the treatment of substance dependence through the facilitation of extinction of response to     cocaine-conditioned cues in cocaine-dependent individuals. If DCS proves successful in this     preliminary study, a controlled treatment trial will be planned. This novel approach could     have implications for the treatment of multiple substance use disorders including     methamphetamine, marijuana and opiate dependence.   "
234822|NCT00921232|"     This study is about the patients life ending and their caregiver, when a return to home is     planned.      This is a behavioral sciences study (= interventional study for french law)   "
223711|NCT00780468|"     This study will provide data on two systems for assigning point values to food choices in a     diet plan. The primary purpose of this study is to compare the effectiveness of the two     systems with regard to changes in body weight.   "
223712|NCT00780481|"     T-PA release is impaired in obese subjects. In order to have a better mechanistic     understanding of t-PA release, we will compare t-PA release to Flow Mediated Vasodilation,     Radial Artery Tonometry, and other markers of endothelial function and oxidative stress.   "
223713|NCT00780494|"     To investigate bevacizumab in combination with carboplatin and capecitabine for patients with     unresectable or metastatic GEJ or gastric cancers. We hope that by adding bevacizumab to     standard chemotherapy for this patient population we will improve Progression Free Survival     by 80% over historical controls.   "
223714|NCT00780507|"     The present study will analyze fecal levels of FC and FL in UC patients who relapse (flare)     while on a QD or a BID Asacol treatment regimen and compare those levels to levels of FC and     FL in UC patients who do not relapse (flare).   "
223715|NCT00780520|"     Glutamine levels decrease during severe sepsis; this may be associated with increased     mortality. The investigators tested the effects of glutamine supplementation on systemic     inflammation in a human sepsis model.      The investigators found that glutamine levels drops significantly during experimentally     induced systemic inflammation. However, glutamine did not affect the degree of inflammation.   "
223716|NCT00780533|"     A total of 144 stroke patients 6 -24 months post onset who are between 45 and 75 years old     will be recruited. A randomized-blocks pretest and posttest control group design will be     applied. Four groups will be involved in this project and the subjects will be stratified on     two variables: impairment level of the hand and side of lesion. Randomization will be done in     blocks of six and each block randomization scheme is within each stratum. Treatment regimens     will be designed to ensure that patients in 4 groups receive equivalent intensity of     treatment (5 days/week for 1.5 hours/day for 4 consecutive weeks) directly supervised by     senior occupational therapists.      Brain and movement reorganization will be evaluated with fMRI and kinematic instrument,     respectively before and after the 4-week intervention period. Clinical measures on motor     impairment, daily function and quality of life will be assessed before, immediately and six     months after intervention. Two examiners blind to group allocation will collaborate to     provide both fMRI and kinematic evaluations and one of them will administer clinical     measures. Before being allowed to work with subjects, the examiner competence will be     assessed by principle investigator and co-principle investigators. Multivariate analyses of     covariance will be used to examine change in brain activation, kinematic variables and     clinical measures as a function of intervention while controlling for pretest data, age and     onset post stroke. Multiple regression models will be established to examine the possible     predictor(s) for functional outcome of each rehabilitation approach. Canonical correlation     analyses will be conducted to quantify the relationship between brain/motor reorganization     and clinical measures.   "
223717|NCT00780546|"     Data will be extracted from the NTUH medical records database, geocoded according to the     street address so that the case number, incidence, etc could be mapped. The spatial data     would be used to detect aggregation of TB cases, existence of hot spots and then determine     if they may merit further investigation or may have occurred by chance. The results from     these GIS-based analyses would address local variations in TB incidence and transmission.   "
223718|NCT00780559|"     The purpose of this study is to determine if an individually tailored diet and physical     enhancement program can improve mobility, physical activity, and neuropathy in people with     early diabetes.   "
223719|NCT00780572|"     The purpose of this study is to determine if an electronic alerting technology improves time     to intervention for possible ADEs, identify what factors affect adoption of ADE alerts, and     whether there is a cost benefit associated with the alerting technology.   "
223720|NCT00780585|"     This is a safety study evaluating the subjects who participated in previous Organon trials of     the drug Org 24448. Patients will undergo a Screening visit, 1 or 2 Evaluation visits, and a     possible Follow-Up period. During the visits, study tests, including echocardiograms, will be     performed to summarize cardiac functioning.   "
223721|NCT00780598|"     The purpose of this study is to evaluate the efficacy and safety of tosedostat in elderly     patients suffering from refractory or relapsed AML.   "
223746|NCT00780949|"     The project is based on adult and paediatric cohorts among the largest ones in Paris and     located at Saint Louis and Robert Debré hospitals. Experiments will be performed at INSERM     Unit U843 in collaboration with the department of immunology and statistics, Robert Debré     Hospital.   "
223722|NCT00780611|"     This study will look at how tumors in the chest and abdomen move when you breathe. Your     doctors are studying if extra 4D CT scans and instructions on how to breathe can help predict     this type of movement and improve the accuracy of radiation treatment. 4D CT scans are     approved by the FDA. A 4D CT scan is different from a regular CT because it moves slower and     takes more pictures. It takes pictures of the way your body moves when you breathe. This     gives doctors more pictures of your body so that they can match your pictures to the way you     breathe.      In this study, instructions on how to breathe will be visual and audio. Visual instructions     will be given to you on a computer screen. You will hear audio instructions through a     speaker.   "
223723|NCT00780624|"     The submitted trial is the first prospective, randomized trial comparing nasal intermittent     positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress     syndrome.   "
223724|NCT00780637|"     Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in     culture. It has been proposed that the nerves of blood vessels are the source of bradykinin     stimulated t-PA release. In order tho test this hypothesis, we intend to infuse bradykinin     into the brachial (arm) artery and the coronary arteries of heart transplant recipients and     control subjects. This is because heart transplant recipients do not have nerves to their     coronary arteries.      This protocol studies the effects of bradykinin on t-PA release in the forearm of transplant     recipients. The brachial artery has intact nerves.      Separate protocols address coronary artery infusions in healthy subjects and transplant     recipients and forearm infusions in healthy subjects.   "
223725|NCT00780650|"     This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat Attention     Deficit Hyperactivity Disorder(ADHD) has effects on the body's ability to defend itself     against low blood sugar.   "
223726|NCT00780663|"     This is a Phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in     patients with low or intermediate grade neuroendocrine cancer. The purpose of this study is     to evaluate the rate of clinical benefit response to quarfloxin treatment including the     reduction in secretory symptoms of flushing and/or diarrhea or the reduction quantifiable     hormones or other biochemical tumor markers.   "
223727|NCT00780676|"     The goal of this clinical research study is to learn if researchers can use genetic tests to     predict who may benefit from treatment with SprycelTM (dasatinib) or selumetinib (AZD6244).   "
223728|NCT00780702|"     Background:        -  The effectiveness of methadone maintenance for treatment of heroin addiction has been          well established. However, patients maintained on methadone may relapse to cocaine use,          even when they are enrolled in a comprehensive treatment program. Relapse has been          attributed to several factors, including drug-associated environmental stimuli.        -  Aripiprazole is a drug used to treat schizophrenia and bipolar disorder, but it may have          other uses. Research has shown that aripiprazole can reduce cocaine-seeking behavior in          rats, and it has been investigated for use in treating amphetamine dependence. More          research is needed to determine whether aripiprazole can prevent relapse to cocaine use          in patients being treated with methadone.      Objectives:      - To determine whether aripiprazole prevents relapse to cocaine use more effectively than     placebo in cocaine-abstinent patients maintained on methadone.      Eligibility:      - Individuals between 18 and 60 years of age who are current cocaine users seeking methadone     treatment.      Design:        -  The study will last up to 41 weeks, with four phases of treatment and a follow-up          evaluation. Three times a week, participants will be asked to report illicit drug use          and provide urine and breath samples. Throughout the study, participants will receive          individual counseling in weekly 40 60 minute sessions. Other samples and tests will be          scheduled as required by the study researchers.        -  Patients will be stabilized on daily methadone over the first 14 days of the study.        -  Weeks 1 14: Participants will receive vouchers for regular cocaine-free urine samples.          Those who successfully complete this phase will continue to the next part of the study.        -  Weeks 13 27: Participants will receive either aripiprazole or placebo along with their          methadone. During this part of the study, participants will keep electronic diaries to          record cocaine use or craving and to record data on mood and activity.        -  Weeks 28 33: Participants will stop taking the aripiprazole or placebo, but will          continue the methadone treatment. Participants will continue to use the electronic          diaries.        -  Weeks 34 41: Participants will have the choice of transferring to a community clinic or          gradually reducing doses of methadone to end the study.        -  Participants will return for a follow-up visit and urine sample 6 months after the end          of the study.   "
223729|NCT00780715|"     This proposal is to fund a pilot study to assess feasibility and refine methodology for an     intended large Scotland wide study on Response to Oral Agents in Diabetes (ROAD). The study     will collect cohorts of patients who have carefully controlled standardised dose titration     and monitoring with an assessment of drug response and side effects over a 6 month period.     The primary aim will be to use these cohorts to investigate phenotypic and genotypic     (pharmacogenetic) determinants of response.      Drug naïve patients will be treated with Metformin. Patients who have failed on Metformin or     are intolerant of Metformin will be randomised to gliclazide, pioglitazone or sitagliptin.     With the ability to capture patient data beyond 6 months via data linkage we will monitor     time to treatment failure and therefore compare which of the 3 oral agents is the best     therapy to use after Metformin in a cost efficient and real world RCT.   "
223730|NCT00780728|"     This study will examine the effects of add-on sildenafil to bosentan monotherapy in patients     with Pulmonary Arterial Hypertension. Patients on bosentan monotherapy will be followed every     6 months to assess if they have met the pre-defined treatment goals. If a patient fails to     achieve these treatment goals or fails to maintain them, sildenafil will be added to their     existing bosentan monotherapy. Patients will be assessed 6 months after start of combination     therapy for changes in 6MWT, Borg dyspnea scale, WHO functional class, quality of life.   "
223731|NCT00780741|"     The purpose of this study is:      To determine the cost-effectiveness of treating NLDO using immediate office probing compared     with deferred probing in a facility setting. As part of the primary objective, the study will     determine the proportion of eyes experiencing spontaneous resolution among subjects     randomized to the deferred probing group.      The secondary objectives are:        1. To determine the success proportion for eyes undergoing immediate office probing as an          initial procedure.        2. To determine the success proportion for eyes undergoing deferred facility probing as an          initial procedure.   "
223732|NCT00780754|"     Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups:     dutasteride treatment group and watchful waiting strategy group. According to the study     protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after     randomization.      There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided     biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate     cancer development for patients with high grade intraepithelial neoplasia (HPIN).   "
223733|NCT00780767|"     This pilot study is mainly aimed to evaluate the feasibility and safety of the percutaneous     Angiojet Rheolytic Thrombectomy (ART) in patients presenting a MPE. Secondarily the     effectiveness of this treatment modality will also be estimated.   "
223734|NCT00780780|"     Diabetics retinopathy remains the major threat to sight in the working age population in the     developed world. Furthermore, it is increasing as a major cause of blindness in other parts     of the world, especially developing countries. Diabetic macular edema (DME) is a     manifestation of diabetic retinopathy that produces loss of central vision.      The triamcinolone intravitreal injection (1-4mg) is indicated to treatment of diabetic     macular edema and it is considered an important treatment since it improves the visual acuity     of patients with resolution of edema.      Nepafenac is a non-steroidal anti-inflammatory drug (NSAID), usually sold as a prescription     eye drop (0.1% solution). Nepafenac is manufactured by Alcon as Nevanac. It is approved by     FDA as well as ANVISA. Pre-clinical studies suggest this medication showed efficacy to treat     ocular posterior segment inflammation.      The purpose of this study is evaluate the efficacy of intravitreal triamcinolone associated     with nepafenac eye drops as treatment of diabetic macular edema.   "
223735|NCT00780793|"     Remission is nowadays the recommended therapeutic objective in rheumatoid arthritis. Once     this objective is achieved thanks to TNF-blockers, the optimal therapeutic strategy remains     unclear, either therapeutic maintenance or progressive DMARD tapering (with a non quantified     risk of disease flare).      STRASS is a 2-arm randomized controlled trial aiming to compare these 2 strategies (DMARD     maintenance or progressive spacing of TNF-blocker injections) in terms of remission     maintenance, relapse risk, safety issues and economic consequences during 18 months.      The inclusion period is 18 months, between September 2008 and February 2010.   "
223736|NCT00780806|"     The purpose of this study is to evaluate the safety of an investigational meningococcal B     rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in     assay development.   "
234823|NCT00921245|"     Patient perspective on Overactive Bladder and symptoms experienced after administration of     Darifenacin   "
223737|NCT00780819|"     On regular (diagnostic) MRI images brain tumors can show contrast enhancement: uptake of an     intravenously administered contrast agent can cause an enhancement pattern that is seen as a     white area on a frequently used MRI protocol (T1 weighted imaging). High grade gliomas are     a common brain tumor that share this enhancement pattern. The goal of surgery is to resect     this contrast enhancing part without causing additional neurological damage. Intraoperative     MRI (iMRI) is a helpful tool in achieving this goal, because it can provide updated images     during resection and correct for deformations that occur in the brain during surgery. These     deformations make preoperative images that are used for standard neuronavigation systems less     reliable. However, due to manipulations during surgery, the contrast uptake during surgery     may differ from contrast uptake in diagnostic MRI. This study aims to relate contrast     enhancement on iMRI and tumor characteristics on tissue samples from the tumor. When the     neurosurgeon considers the resection of the high grade glioma to be complete, an iMRI scan     will be made, and tissue sampling will be performed on the borderzones of the tumor or tumor     resection cavity respectively. This will provide insight in the relation between contrast     enhancement on iMRI and the presence of tumor tissue. Such knowledge is important to improve     effectiveness and safety of iMRI guided brain tumor resection.   "
223738|NCT00780832|"     The purpose of this study is to assess the effects of caffeine reduction/elimination on     urinary symptoms in women with overactive bladders and compare this therapeutic approach to     anticholinergic therapy. We hope to show a reduction in symptoms with caffeine reduction and     determine how effective caffeine reduction is compared to medication. If caffeine reduction     is shown to be beneficial, women may be encouraged to use this strategy before resorting to     medications.   "
223739|NCT00780845|"     The purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump     CABG.   "
223740|NCT00780858|"     Premature luteinization in patients undergoing IUI can occur in up to 24% of cycles. These     patients, according to recent data, have a lower pregnancy rate than controls. The     possibility to avoid premature luteinization with GnRH antagonist may restore the chances of     achieving a pregnancy in these women.   "
223741|NCT00780884|"     Insomnia, a common feature of schizophrenia, has serious consequences for daytime functioning     and quality of life. Although insomnia is most often treated with medication, a growing     number of studies have demonstrated the efficiency of a variety of relaxation techniques,     cognitive behavioral therapies and alternative medicine procedures. Acupuncture is among the     oldest healing practices in the world. Part of traditional Chinese medicine, acupuncture aims     to restore and maintain health through the stimulation of specific points on the body.     Previous studies have demonstrated that acupuncture has a positive influence on a number of     diseases and disorders, among them Depression, Chronic Pain and Sleep Disorders. Hence, the     aim of the present study is to examine the effects of acupuncture as a treatment for insomnia     in schizophrenic patients.The study begins with a 7-day, running-in, no-treatment period,     followes by an 8-week experimental period. During the experimental period, subjects receive     acupuncture treatments twice a week. During the first week of the study (no-treatment period)     and the last week of the experimental period, subjects' sleep is monitored with a wrist     actigraph, and subjects complete a wide spectrum of questionnaires.   "
223742|NCT00780897|"     Premature Ovarian Failure (POF), syndrome observed in young woman, present consequences on     hormonal and leads at definitive infertility. It's a rare and complex syndrome and for this     reason, we propose to initiate a collaborative team network to understand better his genetic     and physiopathology.      We are going to realize a global study of this syndrome with clinical and fundamentals     approaches. We wish that this project allows us to understand better the physiopathology of     this rare disease. Finally, POF responsible genes identification is the base for future     development of therapeutics approaches.   "
223743|NCT00780910|"     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b     (PEG-IFN) and Ribavirin (RBV) in patients with (Genotype 1) hepatitis C, who relapsed after     previous treatment.   "
223744|NCT00780923|"     The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic     inflammation in obstructive sleep apnea.   "
223745|NCT00780936|"     The purpose of this study is to determine the effect of a local anesthetic nerve block on     markers of inflammation and pain after a sunburn. This is important because it may provide     information regarding the way that nerve blocks help with the treatment of pain and in     particular provide preemptive analgesia.   "
227946|NCT00836056|"     The objective of this study is to compare the rate and extent of absorption of clindamycin     300 mg capsules (test) versus Cleocin HCl (reference), administered as 1 x 300 mg capsule     under fasting conditions.   "
223747|NCT00780962|"     Multiple agents have been studied to prevent radiocontrast nephropathy after the     administration of radiocontrast agents. One of these agents is N-acetylcysteine. Previous     trials to assess the efficacy of n-acetylcystenine in the prevention of contrast nephropathy     have been promising.      Previous work in this field has limited applicability to the Emergency Department (ED)     patient population for two reasons:        1. Many of the pretreatment strategies employed in these studies take several hours or even          days to perform, which is not feasible in acutely ill ED patients.        2. Most of these studies were conducted in patients undergoing cardiac catheterization.          This may be a very different population than patients in the ED undergoing abdominal or          chest computed tomography.      We wish to study the efficacy of N-acetylcysteine as an agent to prevent radiocontrast     nephropathy in ED patients undergoing computerized tomography. We propose a randomized,     double-blind, controlled trial comparing saline hydration plus N-acetylcysteine versus saline     hydration alone. The hypothesis of this study is that N-acetylcysteine with normal saline     will be more effective than saline alone in the prevention of radiocontrast nephropathy.   "
223748|NCT00780975|"     This is a study to test the safety and efficacy of an investigational chemotherapy agent in     patients with advanced prostate cancer. Subjects who meet all entry criteria and have signed     the informed consent will be enrolled in the study. Participants will be required to attend     regular clinic visits to receive study medication and have their status monitored. A detailed     explanation can be provided by the investigator conducting the study.   "
223749|NCT00780988|"     Current therapies for metastatic colorectal cancer only prolong life for approximately 2     years. A more innovative therapy that prolongs life significantly or even cures is needed.     Bone marrow transplantation is a curative therapy for patients with leukemias and lymphomas.     Tumor eradication in the case of transplantation of the patient's own marrow (autologous     transplantation) is based on the intensive chemotherapy and/or radiotherapy used for     conditioning. Tumor eradication in the case of transplantation using the marrow of a normal     donor is based on both tumor reduction from conditioning and the immune elimination of tumor     cells by T cells in the donor transplant that recognize the foreign tissue antigens expressed     by the tumor cells and kill these cells. The use of bone marrow transplantation to treat     tumors other than leukemia and lymphoma has been limited, and studies of transplantation of     the patient's own marrow for the treatment of advanced /metastatic breast cancer have not     conclusively shown benefit beyond conventional therapy.      Recently, the Strober lab developed a preclinical model that effectively treated colon cancer     in mice by combining immunotherapy and autologous bone marrow transplantation in order to     markedly augment the anti-tumor potency of immunotherapy. They used the CT26 colon cancer as     the therapeutic target either as a single subcutaneous tumor nodule, as a disseminated tumor     in the lungs and peritoneum, or as a metastatic tumor in the liver depending on the route of     administration of the tumor cells in BALB/c mice. Mice were vaccinated mice with established     primary tumors or disseminated/ metastatic disease with irradiated tumor cells mixed with the     adjuvant CpG, and found that vaccination alone had no effect on tumor growth. Similarly     radiation conditioning of tumor bearing hosts followed by transplantation of bone marrow and     spleen cells or purified T cells and hematopoietic stem cells from unvaccinated donors of the     same strain had no effect. In contrast, radiation conditioning of mice followed by     transplantation of hematopoietic and immune cells from donors of the same strain vaccinated     with tumor cells and CpG cured almost all subcutaneous primary as well as disseminated and     metastatic tumors in the hosts. A similar result was obtained after autologous     transplantation of hematopoietic and immune cells from tumor bearing mice that had been     vaccinated after tumor establishment. Investigation of tumor infiltrating cells showed that     the injected donor T cells do not accumulate in the tumors unless the host has been     irradiated before injection.      Based on this model, we have assembled a team of Stanford University faculty members with     expertise in gastrointestinal cancers, immunotherapy, radiation oncology, and bone marrow     transplantation in the Departments of Medicine and Pathology to translate the preclinical     findings into a Phase I safety and feasibility clinical study for the treatment of 10     patients with metastatic colorectal cancer. Resected tumor cells will be irradiated and mixed     with CpG to create a vaccine. Patients will receive subcutaneous vaccination at weeks 1 and 2     after resection. Six weeks later, immune T cells and then G-CSF mobilized purified blood     progenitor cells will be harvested from the blood and cryopreserved. If needed patients will     receive chemotherapy for tumor reduction. When disease is controlled off chemotherapy,     patients will receive a conditioning regimen of fludarabine (30mg/m2 daily x 3 days) followed     by intensive fractionated total body irradiation. The dose of fTBI will be escalated using a     3+3 design to ensure safety and will range from 400 to 800 gray. The patient will then     undergo hematopoietic and immune cell rescue. They will undergo a third vaccination within     7-14 days after transplant. Thereafter, serial monitoring of tumor burden will continue.      Immune monitoring will occur before and after vaccination as well as after transplantation.     Tests will include in vitro anti-tumor immune responses of T cells (proliferation,     cytotoxicity, cytokine secretion etc.) to stimulation with whole tumor cells and tumor cell     lysates pulsed on to antigen presenting cells, anti-tumor antibody responses, and immune     reconstitution after transplantation.   "
223750|NCT00781001|"     The purpose of this study is to determine if vaporized cannabis is effective as an analgesic     for the treatment of painful diabetic neuropathy.   "
223751|NCT00781027|"     The primary objective is to compare the effect of torsional phacoemulsification and     longitudinal phacoemulsification on central and peripheral corneal thickness/volume after     cataract surgery in patients with Fuchs' endothelial dystrophy.   "
223752|NCT00781040|"     The aim of this study is to find out whether inflammation markers including cardiac markers     have predictive value in evaluation of pathogenesis of sepsis in neutropenic haematological     patients.   "
223753|NCT00781053|"     Transforming growth factor-beta 1 is consistently over expressed in most fibrotic diseases     and displays a variety of profibrotic effects in fibroblasts(25, 26). Activation of TGF-beta     receptors induces the activation of several kinase signalling cascades leading to the     phosphorylation of SMAD proteins as well as to the activation of SMAD-independent kinases     that collectively activate ECM synthesis and fibroblast growth and differentiation into     myofibroblasts. TGF-beta 1 i one of the main mediators in the fibrotic process, associated to     both scarring and a long list of pathologies related to chronic inflammation and which affect     all type of organs and tissues. An increase in TGF-beta1 mRNA and protein levels has been     described in these processes. Peptide 144 (P144)is a acetic salt of a 14mer peptide from     human TGF-beta1 type III receptor (betaglycan). P144 TGF-beta1-inhibitor has been     specifically designed to block the interaction between TGF-beta1 and TGF-beta1 type III     receptor, thus blocking its biological effects. P144 has shown significant antifibrotic     activity in mice receiving repeated sucutaneous injections of bleomycin, a widely accepted     animal model of human scleroderma, and could contribute to the development. The aim of the     study is to asses the long-term safety of topical application of P144 cream in the treatment     of skin fibrosis in patients with systemic sclerosis in an extension open-label treatment     period of 6 additional months.   "
223754|NCT00781066|"     Of the estimated number of 529,000 maternal deaths for the year 2000, 132,000 (25%) were     caused by postpartum hemorrhage (PPH); 99% of these deaths occurred in low-income countries.     Where maternal mortality is high and resources are limited, the introduction of low-cost,     evidence-based practices for primary prevention of PPH is an urgent need. Controlled cord     traction (CCT) is actively promoted in combination with prophylactic uterotonics for the     prevention of PPH. While the administration of uterotonics has been proven effective, there     is no evidence of CCT being beneficial or safe. The investigators propose this study to     evaluate two primary questions:        1. In women having term, single vaginal deliveries in hospital settings, in whom the third          stage is managed with prophylactic oxytocin, does CCT produce a clinically significant          reduction in the incidence of postpartum blood lose?        2. In these women, does CCT produce a clinically significant increase in the incidence of          severe complications, including uterine inversion or the need for subsequent surgical          evacuation of retained placental tissues and membranes (curettage or manual removal)?      To answer these two questions we designed two arms randomized controlled trial.   "
223755|NCT00781079|"     Serious mental illness (SMI) is the second most costly disorder treated in the VHA, yet     clinical outcomes for these patients in public sector settings are often poor due to a     combination of low quality care and severe cognitive and functional impairments evidenced by     this group. While these problems are multifaceted, studies outside the VHA have shown that     using consumer providers (CPs) can improve and augment public care. Similar to recovering     addiction counselors, CPs are individuals with SMI who use their lived experiences to provide     services to others with SMI. CPs can reach out to patients that are difficult to engage,     assist patients with tasks of daily living, offer a variety of rehabilitation (vocational,     social, residential) services, be role models and offer hope for recovery, and facilitate     support groups. Randomized controlled and quasi-experimental trials, all done outside the     VHA, have shown that CPs can provide services that yield at least equivalent patient outcomes     with particular benefits noted on intensive case management teams. Based on these successes     both the President's New Freedom Commission and the Veteran Administration's Mental Health     Strategic Plan call for broader dissemination of CPs as way to make mental health services     more recovery-oriented, a recent national priority. Because of these recent calls, employing     mentally ill veterans has just begun, although no effort has been made to evaluate their     impact inside the VA mental health system. Yet its success outside the VHA and the recent     emphasis on recovery-oriented care suggests the need to test this model in the VHA.   "
223756|NCT00781092|"     The primary objective of this study is to compare two post operative drop regimens for the     management of dry eye and control of healing using FDA-approved ophthalmic solutions.   "
227947|NCT00836069|"     This study is a randomized, double-blind, parallel-group, multi-site, Phase 3, placebo     controlled fixed-dose study of PD 0332334 and paroxetine in 528 outpatients with generalized     anxiety disorder. Subjects will be randomized to the following treatments (132 subjects per     treatment group):      PD 0332334 225 mg BID (450 mg/day), PD 0332334 300 mg BID (600 mg/day), placebo or paroxetine     20 mg QD (20 mg/day).      [QD: once daily, qAM: each morning, BID: twice daily].      The study will consist of 3 phases: an initial screening phase which must be completed 7 to     14 days prior to randomization; an 8-week double-blind treatment phase; and a 2-week     double-blind dose-tapering follow-up phase. After obtaining written informed consent the     investigator will initiate washout of prior psychotropic medications. After the washout of     prior psychotropic medications has been completed the investigator must ensure that the     subject is no longer taking psychotropic medication for at least 14 days prior to the     randomization visit. In addition the investigator must ensure that screening visit procedures     (with the exception of obtaining informed consent) are completed within 14 days of the     randomization visit.      Potential subjects will be approached during a regularly scheduled clinic visit, upon     referral from another physician, or in response to research advertisements. Those who call in     will participate in a short phone pre-screen. This allows us to determine if the person fits     the most limiting inclusion/exclusion criteria before requesting they dedicate a longer     period of time for an in-person screen. Additionally it gives interested individuals the     opportunity to learn more about the study and to review the consent form with family,     friends, and other physicians prior to coming in for the screen and making a final decision     regarding study enrollment. Once the subject has given informed consent, the screening     process for the study will commence.      Subjects who fulfill entry criteria will be randomized to receive ONE of the following 4     treatments in a double-blind fashion: PD 0332334 225 mg BID, PD 0332334 300 mg BID, placebo,     and paroxetine 20 mg QAM. PD 0332334 will be titrated up in the PD 0332334 225 mg BID and PD     0332334 300 mg BID treatment groups. The titration of PD 0332334 will be from 125 mg in the     beginning of the study. In addition the PD 0332334 225 mg BID and PD 0332334 300 mg BID     treatment groups will be titrated down at the end of the study. The 20 mg daily dose of     paroxetine used in this study is based on the approved label for the use of paroxetine in     patients with GAD. Doses were selected for this Phase 3 study based on safety and efficacy     information known about PD 0332334 and pregabalin (PGB), an α2δ ligand approved for the     treatment of GAD in Europe      The subjects enrolled will be men and women ages 18 to 65 who meet DSM-IV criteria for     generalized anxiety disorder with a preponderance of anxious symptoms over depressive     symptoms.      De-identified blood samples will be collected from study subjects at Screening (Visit 1)     according to the standard Molecular Profiling supplement to the protocol. Participation in     this component is optional for study subjects. Samples may be utilized in the future to     investigate GAD (generalized anxiety disorder) genetics, expression metabonomic and protein     biomarker profiles, drug-response, or other genetic or biomarker questions. [Metabonomics:     The study of metabolic responses to drugs, environmental changes and diseases. Metabonomics     is an extension of genomics (concerned with DNA) and proteomics (concerned with proteins). ]      Additionally, partners of male participants who become pregnant during the course of the     study, will be requested to participate in order for the sponsor to collect safety     information and understand the effects, if any, that PD 0332334 may have on her pregnancy or     the fetus. Details of the this sub-study are described in the separate 'pregnant partner'     consent form. Pregnant partners will be be asked to sign a separate HIPAA and consent form in     order to participate.      The investigators have recently received notification of an SAE (Serious adverse event) at     another site that has already begun recruitment for this study. The MediWatch report for that     SAE is included as a Supporting document on WEBRIDGE. Additionally, a protocol change     clarifying the procedures to collect lab information to calculate the estimate Creatinin     CVlearance (CLer) has been submitted. This document has been added as a supporting document     on WEBRIDGE.   "
223759|NCT00781131|"     We hypothesize that pregabalin will decrease post-operative pain scores and opioid use     following abdominal hysterectomy compared to placebo. This study has been designed to     determine if after an abdominal hysterectomy, the addition of pregabalin to their     peri-operative analgesia regimen will demonstrate superior analgesia compared to placebo in     terms of lower pain scores and reduced usage of opioids. The primary outcome will be     post-operative pain, measured by total opioid consumption.      Do women undergoing an abdominal hysterectomy with general anesthesia and receiving     pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the     first 24 hours after their surgery than those women who received placebo?   "
223760|NCT00781144|"     In this study, we are experimentally investigating the assessment of forces used by skilled     clinicians and beginning practitioners in palpatory techniques. The study will assess     pressure used during palpatory diagnosis of the paraspinal region.   "
223761|NCT00781157|"     This study is designed to determine the ED90 for a single dose of phenylephrine for the     treatment of spinal induced hypotension in parturients presenting for an elective CD. The     ED90 is the effective dose at which 90% of subjects will have a positive response to     phenylephrine. The primary outcome measure is the ED90 for bolus phenylephrine. Secondary     outcomes include the need for additional vasopressors, glycopyrolate to treat bradycardia,     and the presence of hypertension following administration of phenylephrine.   "
223762|NCT00781170|"     To evaluate the feasibility and efficacy of a autologous stem cell transplantation followed     by a Melphalan/ Fludarabine based dose-reduced allograft from HLA-identical and     HLA-compatible unrelated donor in patients with Multiple Myeloma. In those with non complete     remission DLI and/ or new agents such as Bortezomib, Thalidomid or Lenalidomide can be used     to upgrade remission.   "
223763|NCT00781183|"     Exercise training has been shown to reduce breathlessness and improve the exercise tolerance     of people with lung disease. However, the effect of exercise training on the walking speed     selected by these people during day-to-day life is unknown. Furthermore,the investigator do     not know if exercise training changes the maximum speed that these people can walk at for a     long period of time. This study will examine the relationship between walking speed and     walking endurance before and following exercise training in people with lung disease and     contribute importantly to our understanding of how patients choose to walk in relation to     their capabilities.   "
223764|NCT00781196|"     Phenytoin, a common anti-seizure drug, leads to cosmetically unacceptable side effect of     gingival overgrowth in a significant number of patients. There is some evidence of     therapeutic effect of folic acid in cases of established phenytoin induced gingival     overgrowth. In this study, the aim is to study the prospective preventive effect of low dose     oral folic acid supplementation on phenytoin induced gingival overgrowth in epileptic     children.   "
223765|NCT00781209|"     The aggregate of data pertaining to brain metastases suggests that optimal results are     achievable with a 2-pronged approach that addresses both the specific focus (with surgery or     radiosurgery) and the surrounding brain parenchymal tissue that may harbor micrometastases.     Patterns of failure following treatment of metastases that arise in the posterior fossa have     not been reliably defined. Although most would agree that radiosurgery alone is not     sufficient treatment for focal metastases in the cerebellum, it may be possible to deliver     less than WBI as an expanded port beyond the SRS volume.      The current study acknowledges that at least two therapeutic modalities are requisite for     patients with cerebellar metastases but hypothesizes that it is unnecessary to extend the     treatment of ostensibly uninvolved brain tissue beyond the limits of the posterior fossa. In     so doing, it is hoped that the putative advantage derived from foregoing whole brain     irradiation (e.g., reduction in neurocognitive impairment) will not be at the expense of     excessive surpratentorial failure.   "
223766|NCT00781248|"     The purpose of the study i to demonstrate the safety and efficacy of a device that intends to     reduce pain/discomfort related to nasogfastric tube usage by reducing the friction between     the tube and internal orifice (nose and pharynx)using micro vibrations   "
223767|NCT00781261|"     Osteonecrosis of the hip is an important cause of musculoskeletal disability and finding     therapeutic solutions has proven to be challenging. Osteonecrosis means death of bone which     can occur from the loss of the blood supply or some other means. Although any age group may     develop osteonecrosis, most patients are between 20 and 50 years old. The most common risk     factor is a history of high steroid treatment for some medical condition. The next most     common associated condition is a history of high alcohol use. There are some cases of     osteonecrosis that occur in patients that are otherwise completely healthy with no detectable     risk factors.      In the earliest stage of the disease, x-rays appear normal and the diagnosis is made using     MRI. The advanced stages of osteonecrosis begin when the dead bone starts to fail     mechanically through a process of microfractures of the bone. As the disease progresses, the     surface begins to collapse until, finally the integrity of the joint is destroyed. A wide     range of surgical treatments with variable success rates have been proposed for the treatment     of the osteonecrosis to preserve joint integrity, including core decompression, whereby the     venous hypertension that ensues is lessened and revascularisation may be induced leading to     bone repair. Nonsurgical treatment options are limited and usually result in a poor     prognosis. Early stage disease can be treated with protected weight bearing and     physiotherapy, however some studies have shown protected weight bearing to be associated with     a greater than 85% rate of femoral head collapse. Unfortunately most studies indicate that     the risk for disease progression is greater with nonsurgical treatment than with surgical     intervention. There are no established pharmaceuticals for the prevention of treatment of     osteonecrosis. Evidence is increasing that the nitrogen containing bisphosphonates may be     beneficial in the treatment of osteonecrosis. One bisphosphonates (alendronate) has been     evaluated in 60 patients diagnosed with osteonecrosis of the hip. Recent clinical studies     have shown very promising results. All patients had symptomatic improvement after one year.     Although the follow up time ranged from 3 months to 5 years, only 6 patients progressed to     the point of needing surgery.   "
223768|NCT00781274|"     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV     in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.   "
223769|NCT00781287|"     This is an investigator-initiated, two-year, randomized, controlled, single-center,     open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to     3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study     will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally)     to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects     with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+     T-cells to a greater extent than a 3-drug HAART regimen.   "
223770|NCT00781300|"     The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium     surgery among patients using loteprednol and dexamethasone during the postoperative period.   "
223771|NCT00781313|"     The primary aim of the survey is to ascertain the emergency preparedness among our families     with diabetes mellitus and to obtain a percentage of unprepared to the ones who are prepared.     The secondary aim is to demonstrate the relationship between disaster preparedness and     factors like socio-economic status, parent's marital status, ethnicity and those who had     prior experience of a disaster to those who have not experienced a disaster.   "
223772|NCT00781326|"     This study will examine whether combined use of an antidepressant medication and the     medication nimodipine reduces risk of depression relapse in patients with vascular     depression.   "
223773|NCT00781339|"     The purpose of this clinical trial is to study the effects of NVC-422 instilled into the     bladder in reducing bacteria in the urine.   "
223774|NCT00781352|"     This study was developed to test the hypothesis that the risk of colorectal cancer recurrence     was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during     colorectal surgery.   "
223775|NCT00781365|"     In this project we develop and implement an intervention to improve hypertension control in a     primary care setting that takes advantage of new technology (home blood pressure     telemonitoring) and team models of care (pharmacist case management). The results of the     project will have important implications for future efforts to improve care provided to many     of the estimated 20 million Americans with uncontrolled hypertension.   "
223776|NCT00781378|"     Recombinant tissue plasminogen activator (rt-PA) is currently the most commonly used     thrombolytic drug in patients with pulmonary thromboembolism (PTE). Optimal dosing with     maximal benefits and minimal risks is of great importance. Considering the lower body weight     in general Chinese population, we compared the efficacy and safety of lower dose rt-PA     50mg/2h regimen with the FDA-approved rt-PA 100mg/2h regimen in selected PTE patients.   "
223777|NCT00781391|"     This study is to demonstrate the safety and efficacy profile, in two different dose regimens     of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of     stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will     be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, &     Warfarin. The expected duration of the study is 24 months.   "
223778|NCT00781404|"     OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO     applied at the time of reperfusion to limit infarct size and LV remodelling in patients with     ACSST submitted to primary ACTP.      DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind     study.      PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction     receiving primary PTCA within 6 hours after symptom onset.   "
223779|NCT00781417|"     This study will evaluate whether earlier intervention with vitamin D in stage II/III chronic     kidney disease will prevent or delay secondary hyperparathyroidism. Subjects will receive     vitamin D or placebo at study entry and will be followed for a period of one year. The     hypothesis is that subjects given vitamin D will have lower PTH and higher 25(OH)D after 1     year compared to placebo. Additionally, there will be less subjects who progress into     secondary hyperparathyroidism in the vitamin D treated group compared to the placebo treated     group.   "
223780|NCT00781430|"     The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the     safety and tolerability of neratinib in healthy subjects and subjects with chronic liver     disease.   "
223781|NCT00781443|"     This is a multicenter, randomized, double-blind, placebo-controlled study designed to     demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway     reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. The     study will randomize approximately 24 patients at five study centers. In the event of patient     discontinuation from the study, additional patients may be enrolled at the discretion of the     Sponsor.   "
223782|NCT00781456|"     This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral     contraceptive compared to placebo for decreasing the frequency and severity of     menstrually-related migraine headaches.   "
223783|NCT00781469|"     Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease affecting approximately     1% of the adult population. The disease is characterised by inflammation of synovial tissue     (ST) in multiple joints, which often leads to destruction of joint integrity, contributing to     serious functional impairment and disability. The contributors to its pathology include joint     inflammation, abnormal cellular and humoral responses, and synovial hyperplasia.     Ultrasonography is a powerful, non−invasive, and feasible way to evaluate synovial     hyperplasia and guide its collection by biopsy.      Although RA is a systemic disease, it is not clear whether the gene expression profile     exhibited by circulated peripheral blood cells and that expressed by the inflamed synovium     mirror one another. Understanding this relationship would be useful not only in potentially     having a relatively non−invasive means to predict response to therapy but it might be useful     in better understanding differences in RA expression amongst patients with this disease, thus     perhaps assisting in target identification through a better understanding of disease     processes.   "
223784|NCT00781482|"     This study will compare the interactions of a placebo and two FDA-approved sleeping     medications, Eszopiclone (Lunesta) and Zolpidem (Ambien), with certain chemical receptors in     the brain. We want to show that we can use positron emission tomography images to measure the     binding of these medications to the receptors.   "
223785|NCT00781495|"     The purpose of this study is to find determinants of insulin-induced weight gain in type 2     diabetes mellitus      Primary objective: To find an association between weight gain after start of insulin therapy     and physical activity levels.   "
223796|NCT00781638|"     Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) will     receive one weekly Adacolumn® apheresis treatment over 5 consecutive weeks, followed by up to     3 optional Adacolumn® apheresis treatments over 3 consecutive weeks. Primary end point is     PUCAI at Week 12.      The main part of the clinical investigation will be continued by a one year follow up for     responders.   "
223797|NCT00781664|"     The purpose of this study is to determine the cumulative irritation potential of the products     listed by the Sponsor.   "
223798|NCT00781677|"     The purpose of this neuroimaging study is to investigate the brain correlates of Major     Depressive Disorder with anxiety symptoms as well as potentially identify predictors of     treatment outcome.   "
223786|NCT00781508|"     Sildenafil (Viagra) is known to reduce pulmonary hypertension. Heart failure patients also     have pulmonary hypertension and several recent reports have shown that sildenafil leads to an     improvement in their exercise capacity. In these studies sildenafil caused a reduction in the     pulmonary and systemic vascular resistances, improved pulmonary gas diffusion and perhaps     increased cardiac output. It is uncertain if left ventricular filling pressures are reduced     and whether there is improvement in left ventricular relaxation. The investigators     hypothesize that in heart failure patients the improvement in exercise capacity associated     with sildenafil is related to a significant reduction in left ventricular filling pressures.     The investigators propose to study 20 patients with stable but moderately symptomatic heart     failure. The study design is a randomized cross-over trial of the administration of a single     dose of sildenafil 50 mg or a matching placebo. Exercise capacity will be determined before     and after the oral administration of sildenafil 50 mg or placebo. Left ventricular filling     pressures will be assessed by Doppler echocardiography and the serum level of B-type     natriuretic peptide (BNP is known to increase with higher left ventricular filling     pressures). After an initial echocardiogram and performing a 6 minute walk test, the patient     will then be given either sildenafil or a matching placebo in a randomized double-blind     fashion. One hr later a blood sample for serum BNP, the echocardiogram and the 6 minute walk     test will be repeated.   "
223787|NCT00781521|"     This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day     dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The     currently approved regimen is twice daily for 10 days.   "
223788|NCT00781534|"     a clinical study of Ginseng its potential affect on diabetes   "
234854|NCT00921648|"     This is a study of the clinical and neuroimaging of general paresis. The investigators     studied six patients with general paresis.   "
223789|NCT00781547|"     The overall aim of this study is to investigate the effects of GH treatment in men with the     Metabolic Syndrome and a high risk of developing type 2 DM.      Forty men with abdominal obesity and impaired glucose tolerance will be randomized to two     parallel treatment groups with GH and placebo for 12 months.      The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo     administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU     per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the     target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will     be reduced by half in the event of side-effects. Oral and written instructions in terms of     administration and dosage will be given.      The treatment can be discontinued by the patient. The treatment should be discontinued if     malignancy is discovered, DM developes, if the subject experience a cerebrovascular disease     and in the event of any other side-effects that is considered as serious.      The treatment code for each subject included in the trial will be kept at the Sahlgrenska     University Hospital Pharmacy. This code can be broken on the request of the investigator.      Compliance will be assessed by collecting empty vials from the study subjects. The treatment     is discontinued at the end of the study.   "
223790|NCT00781560|"     This study is designed to survey the awareness rate of Chinese National Adult Lipid Treatment     Guideline (2007) by cardiologists; To survey the control rate of the patients with     dyslipidemia in real world; and to evaluate the percentage of hyperlipidemia patients who     achieved target LDL-C level according to the Chinese National Adult Lipid Treatment Guideline     (2007) following 8-week treatment by Crestor® 5mg or 10mg   "
223791|NCT00781573|"     Although the optimal duration of clopidogrel (an anti-platelet agent) therapy has been     established after bare metal stent implantation in the blood vessels of the heart, there is     lack of consensus regarding the optimal duration of therapy after implantation of a drug     eluting stents (DES). Current American College of Cardiology guidelines recommend clopidogrel     use for at least one year in the absence of contraindications after DES implantation, while     recognizing that the optimal duration remains unknown. While an extended clopidogrel therapy     (that is beyond the current 1 year recommendation) may increase bleeding complication, it may     reduce the rates of adverse cardiovascular events like heart attacks and repeat     revascularization procedures. A clinical trial which randomizes patients with an uneventful     one year course after a DES implantation, to an additional year of clopidogrel and aspirin     therapy versus aspirin alone, will be able to answer the important question about the role of     extended (2y) dual anti-platelet therapy with clopidogrel and aspirin after DES implants. The     investigators hypothesize that clopidogrel discontinuation at 1 year post-DES implantation is     associated with an increase in cardiovascular events during the one year of follow-up period.   "
223792|NCT00781586|"     The study is considered research because efficacy (how well a drug works) information is     needed in healthy, 25-45 year-old, female subjects with moderate caffeine intake. The     investigational product is available in the United States without a prescription     (over-the-counter) as a nutritional supplement. The purpose of this study is to assess     whether One-A-Day Weightsmart Advanced is safe and can increase metabolism and perceived     energy in female subjects compared with caffeine or placebo (inactive drug). Participation in     this study will last approximately 4 weeks and require about 4 outpatient visits to St.     Luk's-Roosevelt Hospital Center. About 21 subjects are expected to participate in this study.   "
223793|NCT00781599|"     Little is known about the support needed to improve compliance with Chantix for smoking     cessation. This is a two arm pilot study of African American smokers to provide varying     levels of side effect management and compliance support during a 12 week treatment period.     The primary aim of the study is to estimate the effect of induction support compared to     standard care in increasing compliance with Chantix at month 3   "
223794|NCT00781612|"     This is a global, multicenter, open-label extension study. Participants receiving     single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with     other agents in a Genentech/Roche-sponsored study who completed the parent study or who     continue to receive study drug(s) at the time of the parent study closure are eligible for     continued treatment in this study.   "
223795|NCT00781625|"     To investigate if administration of probiotics, either orally or vaginally,        -  Can reduce the number of episodes of acute bacterial cystitis and/or        -  Has tolerable adverse effect profile        -  Improves general QoL in these women        -  Improves the immune function and other physiological stress markers        -  Reduces inflammation in urinary bladder epithelium   "
227966|NCT00836316|"     The purpose of this study is to determine the effects of intraperitoneal administration of     levobupivacaine on pain after laparoscopic cholecystectomy.   "
223799|NCT00781690|"     The current clinical study aims at defining an index of Anti Xa, which is the marker to     evaluate the activity of heparin, at the end of the dialysis treatment and so showing the     possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer.     Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk     of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.   "
223814|NCT00781885|"     This study is an international, open-label, multi-center, Phase II, multiple dose,     dose-finding study to investigate the safety, tolerability and pharmacokinetic     characteristics of BPS-MR tablets in male and female patients with PAH.      Patients who meet the inclusion/exclusion criteria will enter the Treatment Phase at a     Baseline visit. Patients will begin taking one BPS-MR tablet (60µg) twice daily (b.i.d.)     escalating by one tablet b.i.d. each week to a maximum dose of 600µg (ten tablets) b.i.d or     until the patient reaches their MTD. Following the achievement of the MTD, patients will be     down-titrated off BPS-MR in weekly one tablet b.i.d. decrements. Patients may, alternatively,     elect to continue taking the study drug at their MTD in a separate open-label extension     study.   "
223871|NCT00782639|"     The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN)     following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque     320) in patients with moderate-to-severe chronic kidney disease and diabetes mellitus     undergoing cardiac angiography.   "
223872|NCT00782652|"     This study is designed to better understand the effects of nitric oxide, a gas for     inhalation, on patients with right ventricular infarction.   "
223800|NCT00781703|"     The study will evaluate a unique natural experiment that aims to transform the primary care     of patients with depression. The experiment's aim is to cause statewide implementation of an     evidence-based care model for depression by changing the reimbursement system and by using an     established regional collaborative (the Institute for Clinical Systems Improvement) to both     facilitate the model's widespread use and certify that medical groups have implemented it.     Study hypotheses include the following:        1. Newly treated depressed patients in medical groups that have implemented the new          reimbursement and facilitation will report receiving higher rates of best care processes          than such patients in these medical groups before implementation.        2. Rates of best care practices reported to be received by newly treated depressed patients          two years after each medical group implements changes will be maintained at least at the          rate reported by patients one year post implementation.        3. Newly treated depressed patients in medical groups that have participated in the new          reimbursement and facilitation will have greater improvement in depression symptoms and          work productivity and lower healthcare costs than such patients in groups before          participation.        4. Medical group measures of priority for improving depression care, capability to manage          change, and practice systems will be predictive of more patient-reported best care          processes, both at one point in time and in change over time.   "
223801|NCT00781716|"     This study is to compare the clinical effect of CYPHER® stent and ENDEAVOR® stent in patients     with acute ST elevation myocardial infarction. It also aims to analyze the current status of     emergency PCI green channel (time taken from door→ hospital→ PIC sign-off→ needle→ balloon)     for patients with ST elevation myocardial infarction in China.   "
223802|NCT00781729|"     This study seeks to determine whether a specially designed Hatha Yoga program can reduce     hyperkyphosis in men and women who are at least 60 years of age and who have excessive     thoracic kyphosis.   "
223803|NCT00781742|"     The purpose of this research study is to determine whether AZD6765 has an effect on the     patient's depression when taken together with current depression medication. In addition,     information will be gathered on how well AZD6765 is tolerated, investigate the levels of     AZD6765 and the levels of the current depression medication in the blood. In addition, the     research staff will determine if AZD6765 has any mood or calming effects (how you feel).   "
223804|NCT00781755|"     This is a clinical research protocol to study the efficacy of combined varenicline (Chantix)     and motivational interviewing (MI) for smoking cessation in a sample of smokers who have been     diagnosed with schizophrenia or schizoaffective disorder. The study is a double-blind,     randomized, controlled, subacute treatment trial of MI plus varenicline (VAR-MI) versus MI     plus placebo (PLA-MI). The pharmaceutical treatment will utilize Chantix at a dose of 1     mg/day for a period of two weeks.      The primary goal is to determine if VAR-MI decreases baseline behavioral measures of urge and     withdrawal and reduces baseline rates of cigarette consumption. The primary efficacy measures     of VAR-MI vs. PLA-MI treatment are: Minnesota Nicotine Withdrawal Scale, Questionnaire for     Smoking Urge-brief, number of cigarettes smoked per day in the previous week, CO levels, and     Brief Psychiatric Rating Scale and Positive And Negative Symptom Scale scores on the last day     of the study. Other primary outcome measures are to determine the effects of VAR-MI and     PLA-MI on smoking cue-induced urges in tobacco cue reactivity sessions and reward     responsiveness as assessed by a computerized task.   "
223805|NCT00781768|"     The purpose of this study is to compare two different treatment protocols for treating nausea     and vomiting in patients who have undergone bone marrow transplant. Patients will be assigned     to one of two treatment groups.      The first group will recieve ondansetron (Zofran) tablets combined with a medicine called     dexamethasone given IV. Both of these drugs are commercially available.      Patients in The second treatment consists of the first two drugs, plus a newly approved drug     known as aprepitant (MK-869, Emend). This combination will be the treatment being tested. The     combination is approved by the FDA for chemotherapy regimens known to cause a lot of nausea     and vomiting. It significantly decreases the delayed (more than 24 hours after therapy)     nausea and vomiting seen with these regimens.   "
223806|NCT00781781|"     The purpose of this study is to analyze the results of incidence and severity of acute and     chronic GVHD, (see addendum II) and of disease free survival with Alemtuzumab use     (MabCampath®) in haematopoietic transplant of unrelated donor with reduced intensity     conditioning.   "
223807|NCT00781794|"     The purpose of this study is to evaluate the effect of single doses of NSA-789 on the P50     component of the auditory evoked potentials and to assess the safety, tolerability and the     concentration of NSA-789 in the blood, in nonsmoking patients with schizophrenia.   "
223808|NCT00781807|"     A prospective, multi-module intervention based on nutrition management, psychosocial support,     and a controlled home-based physical exercise training program for patients on LVAD- support     will be provided to improve outcomes in terms of survival and patients health-related quality     of life (HRQoL) for the long-term. Physical capacity, neurocognitive, psychological factors,     and adverse events will be assessed as potential independent indicators for HRQoL.   "
223809|NCT00781820|"     The study is focused to prove that the efficacy of a 1% Bifonazole cream is superior to a     placebo cream after non-surgical nail ablation with a 40% urea paste.   "
223810|NCT00781833|"     The primary aims of this study are to determine the safety of the RFM System (Alfred Mann     Foundation, Santa Clarita, CA) in a patient with incomplete SCI and the effect of the RFM     system on lower limb strength and spasticity. The secondary aim is to analyze any improvement     in the participant's mobility.   "
223811|NCT00781846|"     The purpose of this study is to assess the safety, tolerability, and recommended phase 2 dose     of oral ridaforolimus administered in combination with intravenous bevacizumab in patients     with advanced cancers.   "
223812|NCT00781859|"     The objective of this trial is to evaluate the safety and efficacy of intravitreal     microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.   "
223813|NCT00781872|"     Multiple sclerosis is a multifocal inflammatory disease of the central nervous system which     affects young individuals and causes paralysis of the limbs, sensation, visual and sphincter     problems. The disease is caused by an autoimmune mechanism, ie the immune system produces     antibodies and cells which attack the self myelin antigens, causing therefore demyelination.     The disease is clinically evident with relapses of neurological disability due to the     dysfunction of the areas (plaques of multiple sclerosis) in which damage of myelin occurs.     Disability can accumulate with time and the disease enters a progressive phase due to damage     of the axons and irreversible neurodegeneration. Although, effective immunotherapies exist     which downregulate the autoimmune anti-myelin reactivity and reduce the rate of relapses of     MS (like Copaxone and interferons), there is no effective means today to stop the progression     of disability and induce rebuilding of the destroyed myelin (re-myelination). Neuronal stem     cells were shown to possess the ability to restore neuronal activity and produce new neurons     through transdifferentiation. Various other types of stem cells were tested in animal models     with promising results, revealing a potential for restoration of the neurological function in     neuroimmune and neurodegenerative conditions and in central nervous system traumatic injury.     Adult bone marrow derived stromal cells (MSC) were shown to induce similar (to the neuronal     stem cells) immunomodulatory and neuroregenerative effects and were shown in our laboratory     to induce neuroprotection in the animal model of chronic experimental autoimmune     encephalomyelitis (EAE). These bone marrow derived MSCs offer practical advantages for     clinical therapeutic applications, since they can be obtained from the adult bone marrow and     therefore the patient can be the donor for himself, without any danger for rejection of the     cells. In addition, MSCs carry a safer profile and are less prone to malignant     transformation.      Our initial clinical experience with 10 patients with ALS and 10 with multiple sclerosis show     that intravenous and intrathecal administration of MSCs is feasible and safe.      In this study we propose an explorative protocol with the injection of MSCs (both     intrathecally and intravenously) in patients with MS, in an effort to prevent further     neurodegeneration through neuroprotective mechanisms and induce neuroregeneration and     restoration of neuronal function. This will be a phase I/II study.      The primary endpoint will be to further evaluate the safety and feasibility of the treatment     with MSC infusions, in MS patients. Additionally, the migration ability of the transplanted     cells will be evaluated by tagging MSCs with the superparamagnetic iron oxide particle     (Feridex) (an FDA approved cell tracking drug) for detection by MRI. MRI of the brain and     spinal cord will be performed at weeks 1, 4, 12 and 24 to detect the migration of the stem     cells. Clinically the patients will be followed by monthly evaluations of the MS functional     rating scale (EDSS) scale. The MRI, will be also used to evaluate changes in the total volume     of lesions in the brain and the degree of atrophy.      Significance: Our center has performed the first clinical trial with intrathecal and     intravenous injection of adult stem cells in MS and ALS patients and has gained experience     during the last 3 years with this type of stem cells treatment. After having evaluated the     safety and feasibility issues, we intent to proceed to the second stage, to evaluate the     migration ability of those cells (their ability to reach the affected motor areas of the CNS     gray matter, by tracking them with a paramagnetic material and visualize them by MRI), and     evaluate indications of clinical efficacy. This project may provide information for possible     therapeutic uses of this type of bone marrow adult stem cells in MS and ALS but may also     serve as a pilot platform and pave the path for future applications of various types of stem     cells in neurodegerative diseases in general.   "
223826|NCT00782041|"     Primary:        -  To assess the overall response rate of oxaliplatin in patients with bidimensionally          measurable disease at baseline.      Secondary:        -  To assess the safety and tolerability of oxaliplatin        -  To assess time to progression and overall survival.   "
223815|NCT00781898|"     The aim of this project is to conduct a multi-site effectiveness study to determine whether     the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will     significantly improve outcome in parolees and probationers with a history of opioid addiction     compared to TAU alone. Participants will be randomized to either treatment as usual in     community programs or monthly injections of depot naltrexone for six months with treatment as     usual in community programs. The effectiveness of depot naltrexone has never been studied in     opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in     treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are     retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric     functioning, and economic costs and benefit costs of naltrexone.   "
223816|NCT00781911|"     Determine the 6-month progression free survival (PFS) rate associated with IMC-A12 in     combination with depot octreotide acetate (octreotide) in patients with metastatic     neuroendocrine tumors.   "
223817|NCT00781924|"     The purpose of this study is to register the precision of image fusion between live     sonography and CT, MRI or PET/CT of liver lesions and other focal lesions in the abdomen. To     test whether it will be possible to biopsy guided by image fusion.   "
223818|NCT00781937|"     This trial is conducted in North America. The aim of this clinical trial is to evaluate the     potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as     well as in overweight subjects who have medical problems such as hypertension (high blood     pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).      Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed     by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).   "
223819|NCT00781950|"     This Clinical Trial is being conducted to study how patients with peripheral arterial disease     (a condition in which the blood vessels of the extremities are affected) respond to a dietary     regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed     have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of     dietary flaxseed on exercise tolerance will be assessed.   "
223820|NCT00781963|"     Sleep problems are common among older people, and research suggests that insomnia has     negative effects on health and quality of life in older adults. Prior research suggests that     insomnia symptoms are even more common among veterans compared to the general population. In     addition, people with sleep problems also often have depression and other problems that seem     to decrease their quality of life. In this study, we will test two methods of providing     behavioral sleep interventions for treating insomnia in older veterans. The long-term     objective of this work is to identify ways to improve access to these types of behavioral     sleep interventions for older veterans, in order to improve their well-being and quality of     life. This project will be conducted in outpatient clinics of the VA Greater Los Angeles     Healthcare System. Community-dwelling older veterans (aged 60 years and older) with insomnia     will be identified by a postal survey. Enrolled veterans with insomnia (N=150 total, 50 per     group) will be randomized to one of three groups: Individual-Cognitive Behavioral Therapy for     Insomnia (Individual-CBTI), Group-CBTI or a group-based Sleep Education Control Condition     (Control). Measures of sleep, depression and quality of life will be performed at baseline     (enrollment in the study), after the treatment is completed, and during assessments at     6-months and 12-months follow-up. Main outcome measures will include sleep/wake patterns     (sleep questionnaires and wrist actigraphy, which is an objective estimate of sleep and     wakefulness), depression and self-reported quality of life. We hypothesize that the     intervention will improve sleep and will improve depressive symptoms and quality of life at     six months follow-up. We also expect that these improvements will be maintained at 12-months     follow-up.   "
223821|NCT00781976|"     PK, safety study of AZD7295 in HCV carriers   "
223822|NCT00781989|"     This is a prospective, observational study designed to look at ultrasound images of the joint     at baseline and over time, and investigate whether there is a correlation between ultrasound     images and progression of disease. The researchers wish also to see if ultrasound can be used     as a tool to predict progression of Rheumatoid Arthritis in patients with early disease who     have not taken biologics therapy. In addition, the researchers wish to investigate whether     peripheral blood biomarkerscan be identified that predict the progression of erosive     disease in early rheumatoid arthritis, with the intention of testing the most promising     biomarkers in future clinical trials.   "
223823|NCT00782002|"     The purpose of this study is to determine if IMC-18F1 is safe for patients, and also to     determine the best dose of IMC-18F1 to give to patients.   "
223824|NCT00782015|"     This is a study of the effects of 3 oz almonds added daily to a National Cholesterol     Education Program Therapeutic Lifestyle Changes (TLC) diet in improving endothelial function     in patients with Coronary Artery Disease. The study seeks to determine if these effects are     mediated via an increase in Nitric Oxide synthesis and reductions in dyslipidemia and     systemic inflammation.      Vascular reactivity will be assessed via flow mediated dilation with endothelium-independent     and hyperemic flow measured in the right brachial artery by non-invasive 2-dimensional and     Doppler ultrasound. Serum will be collected and analyzed for biomarkers of dyslipidemia,     inflammation, endothelial function, vascular reactivity and oxidative stress.   "
223840|NCT00782236|"     The primary objective of this study is to evaluate the implant stability at the time of     abutment placement on implants placed in healed extraction sockets treated with Straumann     BoneCeramic (SBC) versus Freeze Dried Bone Allograft (FDBA).   "
228311|NCT00844545|"     The purpose of this study is to determine whether eculizumab is safe and effective in the     treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome     (aHUS).   "
223825|NCT00782028|"     We hypothesize that relative to families who receive standard individual postpartum and     pediatric care, families that receive group care will be more likely to have:        -  Improved maternal and child health behaviors: i.e increased breastfeeding, exercise,          child safety measures in the home and decreased smoking.        -  Better health care use for babies: i.e. attend more care visits, on-time and complete          immunizations and decreased emergency services use.        -  Better psychosocial outcomes for the families: i.e. decreased stress and depression, and          increased social support.        -  Improved parenting skills: i.e. improved knowledge of child development, involvement in          developmentally appropriate activities, and parental sense of competence.   "
223827|NCT00782054|"     Severe itching following burn injury is a common complication. As many as 87% of burn     patients report severe itching. The intense itching can increase anxiety and can interfere     with sleep and normal activities of daily living thus affecting quality of life. Often the     itching will become so intense patients will scratch or rub the skin until an open wound     develops. Current treatment for itching includes antihistamines, steroids. and/or     moisturizers, but too often, the patient does not receive relief, even from drugs, and     suffers undesirable side effects.      Swiss-American Products, Inc, has developed a new skin moisturizer containing a blend of     endopeptidase enzymes. These products have resolved itching in other types of skin disease     such as dermatitis. The hypothesis that itching can be reduced through the use of these     endopeptidase enzyme containing products in the post burn population will be tested.   "
223828|NCT00782067|"     This study will investigate if the drug midostaurin taken orally twice daily is effective and     safe in treating patients with aggressive systemic mastocytosis or mast cell leukemia with or     without an additional hematological neoplasm.   "
223829|NCT00782080|"     This study will determine the safety and efficacy of an herbal treatment in children and     adolescents with ADHD.      Study Design:        -  Randomized        -  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)        -  Placebo Control        -  Parallel Assignment   "
223830|NCT00782093|"     The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic     profile of volociximab intravitreous injection in subjects with subfoveal choroidal     neovascularization secondary to age-related macular degeneration (AMD).   "
223831|NCT00782106|"     The purpose of the study is to determine the feasibility of infusing a full 4-week dose of     Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of     recombinant human hyaluronidase needed to infuse that dose with no more than mild local     adverse drug reactions.   "
223832|NCT00782132|"     Since the identification of the human immunodeficiency virus (HIV) and the acquired     immunodeficiency syndrome (AIDS) in the 1980s, there have been significant advances made in     the management and long-term prognosis for infected individuals. Currently, with the advent     of highly active antiretroviral therapy (HAART), HIV-positive individuals may live a healthy     and productive life for years to decades after diagnosis. As life expectancy has increased,     this group of people has begun to engage in family planning. This has created a need for     access to advanced reproductive technologies and fertility treatments. While attempting to     achieve pregnancy, utilization of these services can help to minimize the risk of     transmission in serodiscordant couples, and can allow treatment of subfertile couples. Access     to these services may be limited in Ontario for a variety of reasons. The purpose of this     study is to determine the access to infertility clinics and services in Ontario for couples     in which one or both partners is infected with HIV.   "
223833|NCT00782145|"     RATIONALE: A Web site for stem cell transplant health information and support may be     effective in helping parents improve their health-related knowledge, skills, and quality of     life, which may also improve their children's quality of life.      PURPOSE: This randomized phase III trial is studying a Web-based stem cell transplant support     system to see how well it works compared with standard care in families of young patients     undergoing a stem cell transplant.   "
223834|NCT00782158|"     This study will determine the amount of liver scarring (fibrosis) or liver damage in people     infected with 1) hepatitis B virus (HBV, a virus that can infect the liver); 2) HIV (the     virus that causes AIDS); 3) both HBV and HIV; and 4) neither HBV nor HIV. Liver fibrosis and     liver damage can have many causes, including alcohol, certain medicines, exposure to some     contaminated foods and infections with viruses that affect the liver (such as HBV). About 25     million people in sub-Saharan Africa are infected with HIV and about 50 million with chronic     HBV, yet very little information is available on how many people are infected with both     viruses and the medical implications of co-infection.      Participants in Uganda s Rakai Health Sciences Program (RHSP) or Infectious Diseases     Institute (IDI) clinic who are 18 years of age or older may be eligible for this study.      People enrolled in the study come to the clinic for at least one visit and may be asked to     return yearly. During the visit, participants undergo the following procedures:        -  Questionnaire and a short interview about their health and quality of life.        -  Physical examination and blood draw. The blood is tested for HBV and other factors that          may suggest liver disease. Blood drawn at previous clinic visits or from other studies          may also be tested.        -  Liver evaluation using a FibroScan, a medical device that uses elastic waves to measure          liver stiffness in a process similar to ultrasound scanning. For this test, the subjects          lies flat on the back with the arm extended out. The tip of the machine s probe is          covered with gel and placed on the skin between the ribs at the level of the right lobe          of the liver. The machine produces a little tap on the skin that sends a wave out and          checks how fast the wave moves. The speed of the wave indicates the amount of scarring          in the liver.   "
223835|NCT00782171|"     The purpose of this study is to evaluate the performance of a new dental implant with a     modified surface in different loading protocols.   "
223836|NCT00782184|"     Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40     mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent     reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared     between the two treatment groups.   "
223837|NCT00782197|"     The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the     treatment of knee osteoarthritis.   "
223838|NCT00782210|"     This primary objective of this study is to compare two doses of BI 1744 CL inhalation     solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic     obstructive pulmonary disease (COPD).      The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also     be compared to placebo.   "
223839|NCT00782223|"     Research Protocol Assessment of Hip, Spine and Lower Limbs Digital Radiograph Measurements in     Pediatric Population: using PACS integrated Computer Software (TraumaCad from OrthoCrat ™).      Introduction The integration of the PACS system into many medical institutions created a     plethora of digital measurements to assess anatomic and deformity parameters for torso and     limbs.      A number of commercial digital software is being offered to supply the medical practioner     with tools to assess normal and pathological bony architecture land marks.      The relevant architecture of the pelvis (hip joint), spine and the length and alignment of     lower limbs may be measured using these digital software's.      The validity and accuracy of digital work in comparison to conventional radiographs has been     studied recently, mainly with lower extremity axial alignment, the digital length and     anatomical angles measurements were found to be more reliable in terms of intra observer     reliability than conventional radiographs (1, 2).      Study purposes        1. To compare the, accuracy and reliability of specifically designed digital software          (TraumaCad from OrthoCrat ™) measurements using wizard guidance, to those produced by          using the tool bar (ruler and angle guide tools) of the DICOM folder.        2. To assess intra and inter observer reliability of the TraumaCad software for different          pediatric orthopaedics conditions.           Methods *Twenty hip joins radiographs (AP views) of patients who suffer from Cerebral          Palsy (10) and Developmental Dysplasia of the Hip (10) will be measured using the          TraumaCad software hip joint wizard, and than again using basic tools of the DICOM          folder.           **Twenty spinal scoliosis radiographs (AP and Lat views) will be measured using the          TraumaCad software templates.           ***Ten digital radiographs of long leg standing (AP views) from normal and from patients          with deformities will ne analyzed for length and angular differences using the LLD          wizard.           The following parameters will be measured *Hip joint radiographs: Acetabular Angle,          Central Edge Angle, and Reimer's Index **Spinal radiographs: Cobe Angle (AP views),          Coronal Balance, Sagital Balance. ***Long standing views: length of Femur and Tibia,          mLDFA, mMPTA, mLDTA, JLCA, (the Baltimore numbers).           All measurements will be taken by 4 senior orthopaedic surgeons after consensus          conference for the technique.           Intra observer reliability will be tested by repeating the same set of measurements on 2          different dates, after all radiographs are randomly mixed and done at least 2 days          apart. High resolution single computer will be used for all measurements by all          participating surgeons.           The intra and inter observer reliability for the hip joint measurements will be          calculate to compared between TraumaCad software wizard and the DICOM measurements          tools.           All measurements using TraumaCad software will be analyzed for intra and inter observer          reliability using accepted statistical tools.           The study will be supervised by the department of statistics of TAU for maximum          statistical significance.      1) Sailer J, Scharitzer M, Peloschek P, Giurea A, Imhof H, Grampp S.      Quantification of axial alignment of the lower extremity on conventional and digital total     leg radiographs.      Eur Radiol. 2005 Jan; 15(1):170-3. Epub 2004 Aug 5.      2) Hankemeier S, Gosling T, Richter M, Hufner T, Hochhausen C, Krettek C.      Computer-assisted analysis of lower limb geometry: higher intraobserver reliability compared     to conventional method.      Comput Aided Surg. 2006 Mar; 11(2):81-6   "
223841|NCT00782249|"     Patients with refractory epilepsy who are candidates for a treatment with vagus nerve     stimulation will be prospectively randomized into 3 arms with different vagus nerve     stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during     outpatient clinic visits, within the normal clinical practice.   "
223855|NCT00782431|"     The purpose of this study is to demonstrate the effectiveness (seroprotection and     seroconversion as measured by the hemagglutination inhibition [HI] assay) of an     investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years     of age and older. Subjects will be randomized in a double-blind fashion to receive a single     intramuscular injection of either the investigational vaccine or a licensed egg-derived     seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI     antibody titers on Days 0 and 21, body temperature and injection site reactions will be     monitored daily for 7 days. In addition, subjects will be monitored for adverse events and     rises in body temperature until Day 21 and again until Day 180.   "
223842|NCT00782262|"     Obesity is a growing epidemic and is associated with an increased risk of heart attack and     stroke. The investigators know that obesity leads to abnormalities in how the blood vessels     and the heart function and that these abnormalities are an important cause of this increased     risk in obese individuals. While improvements in these abnormalities have been reported with     marked weight reduction (eg surgery) and lifestyle changes including exercise training, it is     not clear that these abnormalities can be substantially reversed with standard dietary     interventions. Additional information is needed regarding the degree of weight loss required,     the time course of these improvements, nor the mechanisms. All of these have major     implications for the potential role of weight loss in the management of these patients.      The investigators will assess the effects of dietary induced weight loss in both the short     and long term on the function of blood vessels and the heart, and the relationship of any     changes with markers of inflammation that are present in obesity.      By understanding the factors that are important in reversing these abnormalities in obesity     the investigators will be better to identify and reduce heart attack and stroke in obese     individuals in the future.   "
223843|NCT00782275|"     The purpose of this research study is to find out the effects (good and bad) the study     treatment has on participants and their cancer. Temsirolimus has been approved by the Food     and Drug Administration (FDA) in the treatment of renal cell carcinoma. Avastin has been     approved by the FDA for other types of cancers but not renal cell carcinoma.   "
223844|NCT00782288|"     This study will measure the inflammatory effects of digitoxin on IL-8 and neutrophil counts     in induced sputum in stable Cystic Fibrosis (CF) patients and the pharmacokinetics of     digitoxin in serum.      Funding Source-FDA OOPD   "
223845|NCT00782301|"     Confirm the safety of maraviroc when used as a component of combination antiretroviral     therapy in HIV and Hepatitis co-infected patients.   "
223846|NCT00782314|"     We want to evaluate efficacy of Symbicort® Turbuhaler® (formoterol/budesonide) therapy for     asthma in real life conditions. For this purpose we will include both patients that are     treated with Symbicort® Turbuhaler® the classical maintenance only treatment approach as     well as those treated with the SMART approach.   "
223847|NCT00782327|"     To study the effect of losartan (an angiotensin receptor blocker-ARB) on aortic root growth     in patients with Marfan syndrome, already treated with beta-blockers (BB). The effect of     losartan will be compared to placebo. Losartan or placebo will be added to the treatment     regimen in a two-step up-titration scheme over 2 weeks. Start doses of Losartan will be 25 mg     for subjects under 50kg of weight and 50mg if the weight is over 50kg. Uptitration will be     guided by the tolerance of the drug by the patients. Patients will be contacted by phone call     for assessment of side-effects before second step of uptitration.      Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if     the weight is over 50kg   "
223848|NCT00782340|"     The purpose of this study is to see whether droxidopa is effective in treating symptoms of     neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic     Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta     Hydroxylase deficiency.   "
223849|NCT00782353|"     The purpose of this study is to investigate the safety, tolerability, and antiviral activity     of ANA598 in patients with genotype-1 chronic hepatitis C infection.   "
223850|NCT00782366|"     This proof-of-principle clinical trial at Mayo Clinic studies how patients and their     physicians understand and utilize predictive genetic risk assessment. A critical goal of this     clinical trial is to understand how individual patients and their doctors perceive and     respond to genetic risk information that is largely uncertain.   "
223851|NCT00782379|"     RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a     donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps     stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem     cells from a donor are infused into the patient they may help the patient's bone marrow make     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted     cells from a donor can make an immune response against the body's normal cells. Giving     high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after     transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well combination chemotherapy works when given     together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil,     and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.   "
223852|NCT00782392|"     We are developing an oral supplement of carbohydrates to be added to infant formulas in order     to improve brain development, immune function, and overall health of infants and children.     After a careful review of what is known about these sugars, there is very little information     regarding their use in infants and children, although there is some information in adults and     animals.      Many of these sugars have been used in a glyco-nutritional supplement in adults and children,     with minimal or no reported side effects.      We are developing a custom blend of important individual sugars, and need information     regarding their dosing and blood concentrations following oral intake of the carbohydrate     supplement. Timed blood samples following the carbohydrate supplement will provide us with a     better understanding of the most effective dose and the metabolism of these sugars in adults.     This will give us the preliminary information we need for developing an oral supplement of     special sugars that can be added to infant formulas to help improve brain development and     immune function in infants and children.   "
223853|NCT00782405|"     The purpose of this study is to examine the effects of (a) quetiapine XR and (b) mirtazapine     on sleep when given as an antidepressant (monotherapy). We hypothesize that (a) quetiapine XR     has an immediate and lasting positive effect on sleep in depressed patients which does not     differ from the impact of mirtazapine on sleep in this group of patients; (b) in the context     of a secondary objective, we expect an antidepressant effect of quetiapine XR which is     equivalent to that of mirtazapine.   "
223854|NCT00782418|"     This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for     assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.   "
223870|NCT00782626|"     The purpose of this research study is to learn if the study drug RAD001 can shrink or slow     the growth of low-grade gliomas. Additionally, the safety of RAD001 will be studied. RAD001     is a drug that may act directly on tumor cells by inhibiting tumor cell growth and     proliferation.   "
223856|NCT00782444|"     Project summary:      Background: Computer navigation in knee replacement surgery is increasingly being used around     the world, but the documentation of its usefulness is lacking. In order to critically     evaluate this new surgical method, we want to perform a prospective, randomised clinical     trial.      Goal: We evaluate the need for these highly advanced techniques in knee replacement surgery,     and the cost-effectiveness. Long term outcome for the patients will be predicted by using the     radiostereometric analysis (RSA). Also, data from the Norwegian arthroplasty register will     indicate any difference in long term survival of the implant. If there are any differences in     the functional outcome or complication rate, between the two groups, this will be detected in     this trial.      Method: Patients age 50 through 85 years old, with gonarthritis, in need of knee replacement,     are included in the trial. Radiostereometric analysis (RSA), CT-scans, X-rays, clinical     evaluation score systems and laboratory measures are used in the evaluation process. A     cost-effective analysis is performed based on data from Norwegian life tables, data from     SINTEF and from the Norwegian arthroplasty register. Data from the Norwegian arthroplasty     register will be statistically analysed separately for all knee replacements done with     computer navigation in Norway in the last 5 years. Four Norwegian hospitals will collaborate     in this trial (Haukeland university hospital, Haugesund hospital, Haugesund sanitetsforenings     hospital for rheumatic diseases and Lovisenberg diakonale hospital) and patients are     recruited from all four hospitals.      Scientific impact/challenges: This trial will probably have great impact since good evidence     supporting the use of computer navigation in knee surgery is lacking. It is important for the     patient to be confident that he/she receives the best treatment, and it is important for the     health care providers and funding authorities to have clear evidence when choosing between     two different treatment techniques, in order for the patient to benefit.   "
223857|NCT00782457|"     The aim of this study is to compare laparoscopic versus open approach on the surgical     treatment of mid and low-lying rectal cancer, both performed by the same surgical team with     experience in open colorectal surgery and advanced laparoscopic surgery, assessing     preoperative and anatomopathological results and long-term outcome.   "
223858|NCT00782470|"     Understanding how often the bleeding events occur in the subjects who voluntarily decide to     switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also     look into the consequences of switching treatment in QoL (quality of life), development of     target joints, activity level and reasons that might influence the desire to switch.   "
223859|NCT00782483|"     Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work.     Only about 10% of PWS can be completely cleared. The research team believes that the     investigators can improve the response of PWS to laser therapy by using a computer program     that the principal investigator of this study (Dr. Shafirstein PhD) has developed. The     purpose of this study is to test the validity of this computer program. Personalized     Interactive Laser Therapy (PILT) could significantly improve clinical outcomes of laser     treatment of PWS.   "
223860|NCT00782496|"     The purpose of this study is to evaluate if the meal marker and reminder feature of the     Contour meter along with education maintains or increases frequency of testing blood sugar     after meals and enables behavioral changes that may lead to improvement in glycemic control.   "
223861|NCT00782509|"     This primary objective of this study is to compare two doses of BI 1744 CL inhalation     solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic     obstructive pulmonary disease (COPD).   "
223862|NCT00782522|"     In the first part of the the study two new outcome measurements (force reproducibility and     subacromial space) will be tested for reproducibility. Therefore 30 healthy people will be     assessed.      In a second part of the study 60 patients will be randomly allocated to two groups. Group A     (n=30) will perform a traditional training program and group B (n=30) will perform an     eccentric training program.      Before the onset of the training programs, pain, function, maximal force, range of motion,     subacromial space and force reproducibility will be assessed. Both training programs will be     accomplished at home. The first six weeks there will be an appointment with the therapist     once a week to explain, correct and when necessary, aggravate the exercises. The next six     weeks these appointments will be diminished to once every two weeks.      After 6 and after 12 weeks of training the patients will be reassessed for all the     parameters.   "
223863|NCT00782535|"     The purpose of this study is to characterize the dose-response profile of peak and trough     FEV1 after single dose administrations of carmoterol in patients with COPD.   "
223864|NCT00782548|"     The primary objective of this study was to compare the single-dose relative bioavailability     of Alpharma Branded Products Division (Kadian®) and Ligand® Pharmaceuticals Inc. (AVINZA®) 30     mg morphine sulfate sustained-release capsules in healthy adult volunteers under fed     conditions.      The secondary objective of this study was to evaluate the adverse events associated with each     of these 2 different morphine sulfate modified-release commercial formulations   "
223865|NCT00782561|"     The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered     over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental     glomerulosclerosis (FSGS).   "
223866|NCT00782574|"     A Phase I study to assess the safety and tolerability of AZD2281 in combination with     Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to     establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with     advanced solid tumours. Approximately 50 (max 60) patients from 2 countries will be enrolled.   "
223867|NCT00782587|"     The purpose of this research study is to test the safety and tolerability of an experimental     drug, Chemophase, a combination of recombinant human hyaluronidase, (an investigational     synthetic enzyme also known as rHuPH20), and mitomycin (MMC) in the treatment of superficial     bladder cancer when instilled intravesically immediately after TURBT (transurethral resection     of bladder tumor).   "
223868|NCT00782600|"     This study is to test the idea that a controlled release formulation of CE-224,535 may allow     for less frequent dosing and exposure to lower levels of drug than an immediate release     formulation.   "
223901|NCT00776009|"     This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30     mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity     Disorder (ADHD) in a 12-hour laboratory classroom setting.   "
223869|NCT00782613|"     The primary objective of this study will be to evaluate the efficacy of topical ALT-2074     applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.      The secondary objective will be to evaluate the safety of topical ALT-2074 applied twice     daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.      Tertiary objectives will be to provide visual documentation of the improvement of psoriatic     plaques treated with ALT-2074 using digital photography, and to determine the extent of     systemic absorption of topically applied ALT-2074 based on a pharmacokinetic measurement of     blood concentration.   "
223877|NCT00782730|"     This will be a descriptive study measuring the post—void residual of patients in the third     trimester and postpartum. Also, bladder scan values will be compared to the amount of urine     obtained from a Foley catheter to determine the accuracy of the bladder scanner in the third     trimester and postpartum.   "
223878|NCT00782743|"     In this open, prospective, non-randomised, parallel group, unicentric pilot-study will be     compared the progress of valvular and coronary calcification with regard to the therapy with     either acetyl-salicylic acid or phenprocoumon. The progress of calcification is documented by     comparison of cardial stratified computed tomography. It is supposed that treatment with     phenprocumon leads to increased coronary and valvular calcification as well to decreased     blood levels of carboxylated matrix-GLA-protein   "
223879|NCT00782756|"     The purpose of this study is to test the safety of a new plan for treating glioblastoma. The     usual first treatment for glioblastoma is to give focused radiation over 6 weeks in     combination with a chemotherapy called temozolomide. In this study the radiation will be     given over 2 weeks in combination with temozolomide and another drug, bevacizumab, will also     be given. Our idea is that this treatment plan may attack both the tumor and the blood     vessels feeding the tumor more effectively. This study will look at what effects, good or     bad, this approach has on the patient and the tumor.   "
223880|NCT00782769|"     This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete     the DR-OXY-301 study are eligible to participate. The duration of this extension study will     be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including     blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As     in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4     weeks. Subjects will also be required to keep a daily record of the number of times and the     total amount of time the ring was outside the body each day and the reason for voluntary     removal.   "
223881|NCT00782782|"     Congestive Heart failure (CHF) is asociated with changes in cardiac function and vascular     responses. The aim of this study is to characterize these differences. Our hypothesis is,     that there are differences in vascular responses between healthy subjects and patients with     CHF.   "
223882|NCT00782795|"     The purpose of this study is to determine if study drug (Pioglitazone) treatment will improve     pre-diabetes (insulin resistance) or ealy diabetes and improve clinical symptoms (pain) or     laboratory evidence of chronic pancreatitis.      The goal of the investigators is to gather information from this study to help gain     understanding of a potential therapy for chronic pancreatitis.   "
223883|NCT00782808|"     Sixty HIV participants will be enrolled and stratified by PBMC HIV DNA levels, either high     (greater than or equal to 5000 copies/106 cells) or low (less than 5000 copies/106 cells).     Individuals will be enrolled into each group until filled. Screening PBMC HIV DNA levels will     be performed at SEARCH in real-time with less than one-week turn around time. All individuals     will intend to initiate ARV due to meeting MOPH guidelines for such. The protocol team will     work with the primary care physician to facilitate initiation of standard ARV care; however,     initiation of ARV is not a requirement of the study and ARV will not be provided by the     study.   "
223899|NCT00775983|"     This is a randomized, blinded clinical trial comparing overnight laminaria versus same-day     Dilapan for cervical preparation for surgical abortions occurring between fourteen and     eighteen weeks gestation. Comparisons will be made between procedure time, need for     additional dilation, occurrence of complications, and patient and provider satisfaction.      Hypothesis:      Cervical preparation for surgical abortion, between fourteen and eighteen weeks gestation,     with same-day Dilapan is non-inferior to cervical preparation with overnight laminaria within     a five-minute difference.      Primary objective:      Determine differences in procedure times      Secondary objectives:      Examine complications, and need for additional dilation between early second-trimester     surgical abortions performed after cervical preparation with same-day Dilapan versus those     performed after cervical preparation with overnight laminaria   "
223900|NCT00775996|"     The objective of this study was to compare the single-dose relative bioavailability of     Ranbaxy and Abbott (TranxeneeT-Tab®) 15 mg clorazepate dipotassium tablets under fasting     conditions.   "
223884|NCT00775788|"     Structural fat grafting is a form of tissue transfer where the autologous fat is harvested     and subsequently transferred to a different region of the body at the same setting. It is an     excellent technique for filling soft tissue and contour defects. Fat has the benefit of being     abundantly available and easy to harvest. Further more, it is cheap and autogenous and thus     lacks the side effects of synthetic fillers or implants. Autogenous fat transfer is a     relatively common procedure performed by plastic and reconstructive surgeons. The goal of fat     grafting is to provide the patient with a predictable, long lasting autogenous soft tissue     augmentation. Autogenous fat transfer has been used extensively as an adjunct to facial     rejuvenation. As well it has been applied to body contouring and augmentation of the hips,     trochanteric areas, thighs and buttocks, back, torso and breast. The transfer of autologous     fat dates back to 1890s and more specifically as injectable grafts since the 1920s. However,     over the past 20 years the popularity of structural fat grafting has increased as a     contouring modality. Fat transfer to the breast, popularized by Coleman, has been performed     internationally since the 1990s. Despite the duration, the literature lacks accurate outcomes     data on fat transfer to the breast and questions regarding the viability of adipocytes after     the transfer exist. Sources from various publications show cell viability of up to 100%     however studies of long term clinical outcomes quote rates of 10% to 80%.   "
223885|NCT00775801|"     This study will look at the result of using the FLD device as an artificial lumbar disc. The     study will compare the safety and effectiveness of the FLD artificial lumbar disc to an     already approved artificial lumbar disc.   "
223886|NCT00775814|"     The purpose of this study is to determine the efficacy of candesartan, once daily (QD),     combined with hydrochlorothiazide to lower blood pressure in insulin-resistant, obese     patients with hypertension.   "
223887|NCT00775827|"     The study was conducted as an open label, balanced, randomised, two-treatment, two-period,     two-sequence, single-dose crossover bioavailability study on fenofibrate formulations     comparing fenofibrate 160 mg tablets of Ranbaxy Laboratories with Tricor 160 mg tablets in     healthy, adult, human subjects under fasting conditions.   "
223888|NCT00775840|"     The purpose of this study is to determine the effects of candesartan, once daily (QD), on the     N-terminal pro-B-type Natriuretic Peptide laboratory marker in subjects with symptomatic     heart failure with diastolic dysfunction.   "
223889|NCT00775853|"     This study (https://pdrisk.ninds.nih.gov) will determine if people who have risk factors for     Parkinson disease (PD) have biomarkers (objective ways to measure a disease process) that     show that the disease process is actually going on, and if people who have abnormal     biomarkers go on to develop PD during several years of follow-up. Biomarkers of Parkinson     disease (PD) might identify people who are healthy now but may develop the disease later in     life.      Healthy volunteers and people who have certain risk factors for developing PD who are between     18 and 70 years of age may be eligible for this study. People with the following risk factors     are included:        -  Family history of PD        -  Loss of sense of smell        -  Fall in blood pressure when standing up        -  REM behavior disorder (a type of sleep disturbance)      Participants undergo the following tests and procedures:        -  Screening examination        -  Medical and neurological history and physical examination        -  Tests or rating scales for movement, sense of smell, mood, attention, fatigue, pain, and          thinking.        -  Measurement of blood pressure and pulse rate while lying down and then standing up        -  Blood draw for genetic testing        -  Inpatient testing at the NIH Clinical Center for 2-3 days, including:        -  Measurements while blowing against a resistance        -  Measurements of blood pressure and pulse rate        -  Blood draws for levels of various chemicals        -  PET and MRI scanning        -  Lumbar puncture (spinal tap)        -  Electrocardiogram        -  Skin electrical conduction test (test of sweat production)        -  Skin and core temperature measurements        -  Transcranial ultrasound (sound-wave test of the head)        -  Follow-up testing (up to five visits in 18-month intervals) to repeat some of the tests          listed above, excluding the genetic testing and spinal tap   "
223890|NCT00775866|"     In this study we will test a new procedure to guide needle biopsies into the prostate gland     based on MRI. This study will be conducted in patients who may have recurrence of their     cancer in the prostate gland after radiation therapy in order to map out the location of the     recurrence. Using this technique, we will be able to measure the accuracy of MR images in     identifying the site of tumour recurrence.   "
223891|NCT00775879|"     Sevoflurane is widely used for induction of anaesthesia. Several studies showed EEG     abnormalities during mask induction with sevoflurane. The aim of our study was to test the     induction target concentration of sevoflurane on the spikes wave occurrence.   "
223892|NCT00775892|"     A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety     and performance during total anterior cruciate ligament (ACL) reconstruction.   "
223893|NCT00775905|"     The objective of this study was to compare the rate and extent of absorption of Ranbaxy     amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one4ablet dose in     fasted subjects.   "
223894|NCT00775918|"     The purpose of this study was to determine the bioequivalence of Doxycycline monohydrate     formulations after administration of single doses to normal healthy subjects under fed     conditions. These data were to be evaluated statistically to determine if the products meet     bioequivalence criteria.   "
223895|NCT00775931|"     The purpose of this research is to explore what we believe may be a safer and more effective     means of performing stem cell transplantation in patients with Osteopetrosis, using     chemotherapy and radiation designed to bring about engraftment and lessen transplant     mortality. Prior multi-institutional data in past studies found that approximately 30% of     Osteopetrosis patients do not engraft. Therefore, in this study, we utilize a reduced     intensity design of pre-transplant drugs to try to make transplants safer for this disease,     as well as to provide a second infusion of stem cells in patients with matched related or     unrelated donors.   "
223896|NCT00775944|"     This study shall determine whether or not proactive telephone support for smoking cessation     delivered to quitline callers is more effective than standard 'reactive' provision and     whether or not the offer of a voucher for a cost free supply of nicotine replacement therapy     (NRT) has any additional impact on smoking cessation rates achieved by behavioural     interventions.   "
223897|NCT00775957|"     A study to determine the accuracy of FLT-PET in quantifying tumor cell proliferation at the     initial staging of patients with Non-Hodgkin's Lymphoma in comparison wit the gold standard     FDG-PET.   "
223898|NCT00775970|"     The purpose of this study is to determine whether walking exercise after dietary treatment of     obesity is associated with a decrease of the daily spontaneous physical activity and\or with     an increase of the time spent in sedentary activities. Our hypothesis is that the practice of     walking as an exercise during the phase of weight stability following the dietary treatment     of obesity leads to a reduction of spontaneous physical activity and\or to an increase in the     time spent in sedentary activities.   "
223902|NCT00776022|"     An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover     bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories     Inc. (A subsidiary of Ranbaxy, Inc) with Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of     Pfizer Labs (Division of Pfizer Inc.) in healthy, adult, human subjects under fed condition   "
223903|NCT00776035|"     Sex has a major impact on myocardial metabolism and blood flow. In subjects without heart     failure men's hearts tend to use proportionally more glucose and women's hearts use more fat     and have higher blood flow.      Obesity is a major risk factor for Heart Failure. In subjects without heart failure,     increasing body mass index is predictive of increased blood flow and fatty acid metabolism in     women, but not men.      To measure blood flow and metabolism we will be using radioactive materials and a PET     (positron emission Tomography)scan to study the metabolism of the heart.      Hypotheses: 1) Women with nonischemic heart failure will have higher levels of heart blood     flow and fatty acid metabolism and lower glucose metabolism rates than men with nonischemic     heart failure 2) Patients with obesity-related HF have a myocardial metabolic profile that is     similar to that of obese subjects without heart failure and different (higher FA metabolism)     from that of nonobese Heart failure patients.   "
223904|NCT00776048|"     This study is being conducted to compare healthy patients versus patients with muscle     tightness in their leg(s) after an acquired brain injury using walking trials time, a balance     test, and foot pressure data. This data is obtained using foot pressure sensors, timers, and     distance walked.   "
223905|NCT00776074|"     The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free     formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with     uterine fibroids.   "
224003|NCT00784394|"     This phase I clinical trial studies the side effects and best dose of diindolylmethane in     preventing cancer in healthy volunteers. Diindolylmethane is formed in the stomachs of people     who eat a chemical that is normally found in vegetables, including cabbage, broccoli,     Brussels sprouts, cauliflower, and watercress. Diindolylmethane may prevent the development     of cancer.   "
223906|NCT00776087|"     BIOTRONIK Home Monitoring (HM) service enables the doctors to safely follow up (FU) their ICD     and CRT-D patients in a remote fashion, with fewer in-clinic consultations. This may result     in a more efficient FU and cost-savings for the health care payer.      The EuroEco study:        1. Outlines a new HM-based FU model for the ICD and CRT-D patients that combines in-clinic          consultations and regular check ups of the patient/ICD/CRT-D data received through the          HM service.        2. Compares the direct costs for physicians and clinics for the HM-based FU of ICD and          CRT-D patients versus the traditional FU.        3. Compares the indicators of patients' safety between the two FU models.   "
223907|NCT00776100|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Sometimes, after     chemotherapy, the tumor may not need more treatment until it progresses. In this case,     observation may be sufficient. It is not yet known whether radiation therapy is more     effective than observation after chemotherapy in treating non-small cell lung cancer.      PURPOSE: This randomized phase II trial is studying how well radiation therapy works compared     with observation after chemotherapy in treating patients with stage IV non-small cell lung     cancer.   "
223908|NCT00776113|"     The objective of this study was to compare the single-dose oral bioavailability of Carvedilol     12.5 mg tablets of Ohm Laboratories with Coreg 12.5 mg tablets in healthy, adult, human     subjects under fasting conditions.   "
223909|NCT00782821|"     The purpose of this research study is to find out the effects of adding B lymphocyte     modulating agents in patients at risk for rejection receiving an anti-rejection     (immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and     corticosteroid therapy.   "
223910|NCT00782834|"     This is a phase II study of Nilotinib for patients with advanced GIST that cannot be     surgically removed. Patients are candidates for the study if their tumors have progressed on     imatinib and sunitinib or if they were intolerant to these drugs. Patients may have received     other investigational therapies as well. We are testing the benefit of nilotinib in advanced     GIST looking at the length of time disease is controlled as well as the response of the     disease to the drug.   "
223911|NCT00782847|"     This study is designated to evaluate the effect of a patients' educational program called     DiaNe® for consultation and support people with diabetic kidney disease in an early stage.     The aim of the study is to examine if the program is suitable to stop deterioration of kidney     function and to maintain or improve glycemic control. The consultation and support program     DiaNe® substantially contributes to a better understanding of the affected clients for this     complex clinical picture, allows them for specific interventions and creates the rationale     for an active therapeutic relationship.   "
223912|NCT00782860|"     The main purpose of our study was to which determine factors, those measured by ultrasound     and also demographic and clinical factors (age, number of previous pregnancies, abortions and     deliveries) predict outcome of medical treatment for early pregnancy failure. Our hypothesis     was that gestational sac volume predicts outcome of medical treatment for early pregnancy     failure.   "
223913|NCT00782873|"     The purpose of this study is to evaluate the safety of propofol-based,     gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper     endoscopy.      The investigators aim to test the hypothesis that it is safe to use balanced-propofol,     gastroenterologist-administered sedation in obese patients.   "
223914|NCT00782886|"     Image-guided surgery essentially describes the interactive use of medical images during a     surgical procedure and is often referred to as a global positioning system (GPS) for     surgery.   "
223915|NCT00782899|"     Observational, non-interventional, longitudinal, prospective,multicenter, open label (No     treatment is involved). 4 assessment will be carried out , in months 0, 1, 3 and 6. The     primary objective is to asses evolution of subjective well-being and depressive symptoms in     schizophrenic patients for six months after an acute episode treated in outpatient     psychiatric units. The primary endpoint is: Total score in Subjective Well-being under     Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment     after 6 months vs baseline. Secondary objectives include: To evaluate the relationship     between subjective well-being and psychopathology, subjective clinical global impression,     adverse events and compliance of treatment. Also to compare the clinical global impression of     psychiatrist and patient. In addiction to know the clinical, social and demographic factors     involve in the subjective well-being and patient clinical global impression.   "
223927|NCT00783055|"     The purpose of this study is to assess the status of perceived autonomy and to evaluate the     effectiveness of individually tailored programmes on perceived autonomy in physically frail     older people living in nursing homes.   "
223916|NCT00782912|"     Postpartum anemia (PPA) and Postpartum depression (PPD) are common afflictions affecting     women after childbirth. Both disorders have a significant impact on women's health and     functional status. Despite common symptoms and characteristics, a link between these entities     has not been adequately studied. The objective of this study is to determine whether     postpartum anemia is an independent risk factor for the development of postpartum depression.     This prospective cohort study will include all women delivered by elective term cesarean     delivery. Hemoglobin and iron levels will be measured, standardized questionnaires for     assessment of PPD, functional status and lactation will be administered before discharge and     at 3 & 6 weeks post partum. Hemoglobin levels at each time point will be analyzed for     correlation with depressive symptoms, functional status and lactation success.   "
223940|NCT00783562|"     Childcare in nursery schools has been shown to be associated with an elevated prevalence of     neck, shoulder, arm and low back disorders. The current evidence suggests that exercises seem     to be the only effective preventive intervention. Thus the purpose of this study is to     determine the effectiveness of an extension-oriented exercise program in preventing low     back/neck pain and functional disability in nursery school teachers. In addition, the     investigators also sought to identify the occurrence of musculoskeletal complaints in this     category of workers.   "
224000|NCT00784355|"     The causes of acute pancreatitis in Finland are alcohol overuse (60%), cholecystolithiasis     (20%) and idiopathic (i.e. etiology unknown)(20%). Acute pancreatitis may recur in over half     of cases and may be fatal in severe cases in 30%. Majority of idiopathic pancreatitis are     caused by microlithiasis in gall bladder. The purpose of this randomized study is to prevent     recurrence of idiopathic pancreatitis by performing laparoscopic cholecystectomy compared to     non-operative group in 2 years follow-up of patients.   "
223917|NCT00782925|"     At Lyon University Medical Center, back problems are the leading cause of sick leave. The     course of lower back pain is usually relatively short (recovery occurs within 4 to 6 weeks in     90% of cases). However, about 5-10% develop chronic lower back pain. Although this is a     relatively small group, the economic consequences are enormous (accounting for 70 to 80% of     the total cost of lower back pain).      Nowadays, some very general training sessions are offered to workers at Lyon University     Medical Center, irrespective of their lower back pain status. These very general training     sessions are mostly preventive and primary in nature (like back school program) despite the     fact that these people already have a history of lower back pain, the main risk factor of     recurrence and chronic pain.      Since the 1980, some multidisciplinary functional restoration programs have been advised as a     strategy for secondary and tertiary prevention of lower back pain.      The purpose of this randomized controlled trial is to assess the effectiveness of physical     exercise combined with an educational program and self-led exercise for Lyon University     Medical Center workers with lower back pain. We hope this intervention will reduce the risk     of recurrence and chronic lower back pain.   "
223918|NCT00782938|"     Drugs with anticholinergic potential increase the risk of postoperative transient and     persistent cognitive dysfunction especially in cardiac patients. The investigators main goal     is to identify preoperative risk factors and to monitor postoperative patients' state in     relation to SAA activity and bilateral BIS-EEG changes.   "
223919|NCT00782951|"     Patients will receive a single intravenous (IV) infusion administered over 3 minutes of     either ORG 28611 (SCH 900111), 0.12 mg/kg morphine sulphate, or placebo, within 6 hours after     dental surgery, when they experience moderate to severe dental pain. Patient will then be     evaluated with pain assessments at Baseline, 5, 10, 15, 30, 45, 60, and 90 minutes; and 2     through 8 hours or before rescue medication is needed.   "
223920|NCT00782964|"     Observational, non-interventional, longitudinal, prospective,multicenter, open label (No     treatment is involved). 3 assessment will be carried out . The 1st one will be on baseline,     the 2sd one after a significant change in pharmacological treatment and 3rd one after a     second significant change in pharmacological treatment. If there isn´t any significant change     in therapeutic plan a control assessment will be carry out in week 10th and 24th. A     significant treatment change is defined as a change in SSRI/SNRI, to add another SSRI/SNRI or     a augmentation treatment added to SSRI/SNRI. The primary objective is to describe     therapeutical strategies (antidepressant change, association with another antidepressant or     association with another treatment) in the management of patients with MDD with incomplete     response or intolerance to an antidepressant after a first or a second failure; and when the     psychiatrist decide a change of strategy. Secondary objectives include: 1 - To describe the     clinic profile of depressive patients with incomplete response or intolerance to an     antidepressant after a first or a second failure; 2- To describe the profile of patients     based on therapeutic strategies used and number of therapeutic strategies; 4- Evaluate the     use of health resource due to lack of fast onset of action, and social cost (productivity,     care givers…); 5 - To associate clinical variable with therapeutic action by psychiatrist.   "
223921|NCT00782977|"     The purpose of the study is to evaluate the effectiveness of continuous oxygen provided by     nasal prongs in preventing or delaying hypoxemia during the apneic period that occurs after     induction of general anesthesia. This will be evaluated by measuring the arterial oxygen     tension (PaO2).      The study will also evaluate whether there is any difference in PaO2 when using nasal prongs     with flow rates of 5 L/minute versus 10 L/minute of oxygen.   "
223922|NCT00782990|"     Objective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress     incontinence (SUI).      Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive     35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district     general hospital at Leganés (Madrid), Spain.      Intervention: 24 patients randomised to TVT and 25 to CS.   "
223923|NCT00783003|"     GW642444 and GSK233705 are in development for treatment of Chronic Obstructive Pulmonary     Disease. Development of these two inhaled drugs as a combination therapy would have potential     for improved patient benefit as they both work through different mechanisms and the combined     bronchodilatory effect might be additive. This study will look at the this combination, for     the first time, in healthy Japanese subjects.   "
223924|NCT00783016|"     The pain control in surgical abdomen has been in debate in masking the correct diagnosis. We     would like to investigate the effect of pain control on the diagnostic accuracy of surgeon in     suspicious appendicitis patients.      We would give morphine or placebo to the patients suspected of appendicitis randomly and in     double-blinded manner, and then surgeons would exam the patient and give the impression for     the possibility of the appendicitis(grading 1 to 4).      With this grading, we compare these impression between two groups.   "
223925|NCT00783029|"     The purpose of this research study is examine the response of the blood vessels in the eye to     a light flicker stimulus using the Dynamic Vessel Analyzer (DVA) on two separate days in     healthy individuals. The DVA uses an instrument which is used during routine eye     examinations. The hypothesis of the study is that the changes in eye's blood vessel will be     similar between the two visits; thus establishing reproducibility of the measurements for     future comparisons to individuals with stroke or heart disease. In addition, this study will     compare the eye's blood vessel responses to responses of the blood vessels in the arm using     Doppler ultrasound.   "
223926|NCT00783042|"     The aim of this study is to investigate whether the non-invasive ultrasound method for     assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow     reserve (TTDE-CFR), can be used to measure drug effects.   "
223954|NCT00783744|"     To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin     versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of     change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus     glimepiride and metformin.   "
223955|NCT00783757|"     The purpose of this research study is to see if Near-Infrared Tomographic Optical Breast     Imaging (TOBI) scans can help monitor breast tumor response during treatment for breast     cancer. The images created by the TOBI scan show changes in blood blow and oxygen levels in     breast tissue.   "
224004|NCT00784407|"     The objective of this study is to compare the results of total thyroidectomy using the new     harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device     (HARMONIC ACE).   "
223928|NCT00783068|"     Rationale: The vagus nerve exerts an anti-inflammatory effect in in vitro and animal     experiments. This 'vagal anti-inflammatory pathway' is mediated by the nicotinergic α7nACh     receptor that can be selectively stimulated by GTS-21. Activation of the cholinergic     anti-inflammatory pathway via vagus nerve stimulation or α7nAChR agonists improves outcome in     animal models of endotoxemia, sepsis and experimental arthritis. Up to now, the     anti-inflammatory effects of oral administration of GTS-21 in humans in vivo has not been     investigated.      Objective: Primary aim: to investigate the anti-inflammatory effects of oral administration     of GTS-21 on the inflammatory response in the human endotoxemia model and the subsequent     inflammation-induced subclinical organ dysfunction. Secondary aim: to measure the effect of     LPS administration in the absence or presence of GTS-21 in human volunteers on vagal nerve     activity measured by heart rate variability analysis.      Study design: Double-blind placebo-controlled randomized cross-over intervention study in     healthy human volunteers during experimental endotoxemia.      Study population: Non-smoking healthy male volunteers, age 18-35 yrs Intervention: Subjects     will be tested in a cross-over design in 2 separate sequential sessions, 2-4 weeks apart. A     total of 12 subjects will be randomly assigned to one of two dosing groups in a 1:1 ratio:     GTS-21 followed by Placebo n=6, Placebo followed by GTS-21 n=6. Subjects will receive 150mg     GTS-21 or placebo orally tid 3 days before LPS injection and an oral dose of 150 mg GTS-21 or     placebo the morning of the day of LPS administration (07:00 AM). Subjects will then receive     an oral dose of 150 mg GTS-21 or placebo at 08:00 AM and another oral dose of 150 mg GTS-21     or placebo at 1 hour before LPS administration (t=0). Before LPS injection, prehydration will     be performed by infusion of 1.5 L 2.5% glucose/0.45% saline solution in 1 hour. One hour     after the last dose of GTS-21 or placebo, LPS derived from E coli O:113 will be injected (2     ng/kg iv in 1 minute). There will be a 14 day washout period for patients in all groups. The     last group of subjects will be subjected to an identical dose of LPS and placebo at two     different moments 2-4 weeks apart to obtain time controls.      Main study parameters/endpoints: Main study endpoint is the concentration of circulating     cytokines after LPS in the absence and presence of GTS-21.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: A medical interview and physical examination is part of this study.     Approximately 350 ml blood will be withdrawn and urine will be collected. There will be mild     discomfort associated with participation in this study, as LPS induces flu-like symptoms for     approximately 4 hrs. GTS-21 was found to be well tolerated at a dose of 150 mg three times     daily (450 mg/day).   "
223929|NCT00783081|"     The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment     of intermittent claudication.   "
223930|NCT00783094|"     This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the     efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an     open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese     men with signs and symptoms of benign prostatic hyperplasia.   "
223931|NCT00783107|"     This is a randomized, double-blinded, Phase I dose escalation-deescalation protocol (DEP) of     cyclosporine inhalation solution in patients with Gold Stage III chronic obstructive     pulmonary disease.      The purpose of the study is to evaluate the safety and effectiveness of aerosolized     Cyclosporine in treating COPD.      The specific aims of the study are:        1. To identify the short term (28 day) safety profile of CyIS immunotherapy in severe COPD          (GOLD III) patients with particular attention to airway reactivity and infection risk.        2. To identify the pharmacokinetic-pharmacodynamic relationship of CyIS using peripheral          blood markers of an adaptive immune response as endpoints in subjects with severe COPD          (GOLD III) treated short-term.      Subjects between 45 and 70 years of age with a confirmed diagnosis of COPD, Gold Stage III,     and meet all the study requirements, will be enrolled in this study. A total of 24 subjects     of either sex will be enrolled in this study. A total of 4 subject cohorts (n=6) will     participate in the protocol.   "
223932|NCT00783120|"     Schizophrenia is a major psychotic disorder that presents an enormous burden to the patients     and their relatives. Despite treatment with second generation antipsychotics, negative     symptoms and cognitive impairment often persist and determine an unfavourable course     including reduction in life quality. Prefrontal repetitive transcranial magnetic stimulation     (rTMS), a promising noninvasive biological technique, applied adjuvant to ongoing     antipsychotic treatment was demonstrated to be safe and was associated with improvement in     negative symptoms in the majority of the small placebo-controlled trials.      The primary objective of the trial is to investigate the efficacy of high-frequency rTMS     (add-on to antipsychotic therapy) in the treatment of negative symptoms in schizophrenia     compared to sham stimulation (placebo).   "
223933|NCT00783133|"     This was a crossover study designed to see if patients with seasonal allergy symptoms     preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or     Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given),     followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients     were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.   "
223934|NCT00783146|"     This was a randomized, double-blind, parallel-group, multicenter study that used both an     active control (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily     during a 15-day treatment period. The active treatments and placebo were allocated in a 2:2:1     ratio.   "
223935|NCT00783497|"     High blood pressure is a common health problem among people in the United States. This study     will examine the ways that stress and ethnicity play a role in the development of high blood     pressure.   "
223936|NCT00783510|"     This is a global registry, to evaluate the long-term safety of Humira® in patients with     moderate to severe polyarticular Juvenile Idiopathic Arthritis (JIA), that are treated as     recommended in the Humira® product label. Patients treated with MTX will be considered a     reference group. Patients will be followed in both the Humira® and Methotrexate (MTX) arms     for 10 years from the enrollment date into one of the treatment arms.   "
223937|NCT00783523|"     Brain vascular malformations, including arteriovenous malformations (AVM), cavernous     malformations (CVM) and aneurysms, are a source of life-threatening risk of intracranial     hemorrhage. The etiology and pathogenesis are unknown. There is no medical therapy presently     available. Prevention of spontaneous intracerebral hemorrhage (ICH) is the primary reason to     treat brain vascular malformations. The goal of this study is to: begin pilot studies to lay     the groundwork for future clinical trials to develop medical therapy to decrease ICH risk.      Matrix metalloproteinases (MMPs) regulate the extracellular matrix in association with     various hemorrhagic brain disorders. MMP-9 has been most consistently associated with     vascular wall instability and hemorrhagic brain disorders. Doxycycline, a non-specific MMP     inhibitor, may enhance vascular stability, thus reducing the risk of spontaneous hemorrhage     in brain vascular malformations by decreasing MMP-9 activity.   "
223938|NCT00783536|"     This is a randomized, open label, active-comparator, parallel design, outpatient, multicenter     study being conducted in Mexico. Subjects with early active Rheumatoid Arthritis (RA) who     have not received treatment with a Disease-modifying antirheumatic drug (DMARD) in the     previous 6 months will be eligible for the study. Study subjects will be randomized into one     of two treatments groups and receive either etanercept + methotrexate or standard     non-biologic DMARD therapy.   "
223941|NCT00783575|"     The purpose of this study is to look for the NOD2 gene in children with Inflammatory Bowel     Disease (IBD) and their parents. We hope to understand this NOD2 gene better by determining     whether children that have IBD have the NOD2 gene. In those with the NOD2 gene, we want to     see if the type of gene abnormality predicts the nature of their disease and if the genetic     information helps doctors decide what therapies and/or treatments to use for their patients.     We also hope to explore the relationships between known serologic markers of IBD (ASCA,     pANCA, ompC) and the clinical characteristics and course of children with IBD.      About 1500 children and as many of their parents as possible will take part in this study.     Children who are newly diagnosed with IBD as well as children that are being seen in the     Children's Health System are eligible to participate in this study. We are looking for     children 18 years old or younger to participate. If possible, we would also like both parents     of the child to participate.   "
223942|NCT00783588|"     The study is a Phase Ib extension trial that will assess the toxicity, tolerability, and     safety of up to two repeated administrations of 1x10^8, 3x10^8, or 1x10^9 autologous     Ad-ISF35-transduced CLL B cells given intravenously to patients with CLL who tolerated ISF35     in the prior Phase I infusion trial at M.D. Anderson.   "
223943|NCT00783601|"     The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in     patients with chronic asthma.   "
223944|NCT00783614|"     The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy)     and aspirin use on risk for cardiovascular disease among HIV infected persons.   "
223945|NCT00783627|"     Sickle Cell Disease (SCD) is the most prevalent genetic disease of haemoglobin.The underlying     abnormality in the red blood cell (RBC) of SCD is the presence of abnormal sickle cell     hemoglobin (HbS), which, when deoxygenated, becomes relatively insoluble, forms aggregates     with other hemoglobin molecules within the RBC and causes rigid deformation of the cell.     Acute pain vaso-occlusive crisis, strokes and acute chest syndrome are the main acute     complications, sometimes life-threatening, often leading to organic and functional squeal.     Although the common SS form of SCD is a unique gene disorder, the range of the clinical     severity is remarkably wide and striking, suggesting that clinical polymorphism is due to     modifier genes and environmental factors.Most of the research efforts have been focused on     the biology of haemoglobin and of the red cells. Meanwhile, the complex pathophysiology of     SCD is undoubtedly influenced by the many physiologic functions of the vascular wall. In line     with this hypothesis are several reports of increased circulating levels of     endothelium-derived surface molecules in SCD patients suggesting marked endothelial stress in     SCD. Similarly, other processes that involve the endothelium, such as leukocyte adhesion and     activation, may play a role in vascular occlusion. This accumulation of data raises the     unanswered question of the mechanisms of endothelium maintenance and regeneration in SCD.     Through these mechanisms, it is likely that function or dysfunction of the vascular     endothelium contributes to the overall vascular pathobiology of this disease, which includes     recurrent vaso-occlusions, stroke, leg ulcers, chronic organ ischemic damages, and     neovascularizing retinopathy that affect nearly one-half (48%) of the surviving patients by     the fifth decade.Thus, our groups have combined their respective clinical and biological     expertises to test the hypothesis that SCD is a condition of specific endothelial stress and     dysfunction upon chronic and Paracystic abnormal interactions with circulating cells and     abnormal oxygen delivery to tissues. Specifically, we hypothesize that chronic endothelial     stress with detachment of activated endothelial cells require increases mobilisation of the     Endothelial Progenitor Cells (EPCs) that maintain endothelial homeostasis to avoid major     thromboembolic events and vasospasm. Inappropriate mobilisation or maturation of the EPCs in     SCD may participate to the severity of the disease.   "
223946|NCT00783640|"     To demonstrate the absence of photoirritation and photosensitization potential of the product     Dermacyd Femina (Lactic Acid) Pocket BR.   "
223947|NCT00783653|"     In this study safety and tolerability of two dose levels of SU 11248 (sutent) with standard     chemotherapy in patients with FLT3 mutated AML over 60 years will be evaluated.   "
223948|NCT00783666|"     The purpose of this study is to demonstrate the absence of photoirritation and     photosensitization potential of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).   "
223949|NCT00783679|"     The purpose of this study is to test the accuracy of a new noninvasive way to measure how     much blood our heart pumps per minute. This new way measures the heart's pumping activity     from outside the body, instead of breaking the skin and measuring it from the inside.      Subjects will breathe normally through a mask while we record how fast and how much air they     are breathing. We will have them re-breathe some of the air they breathed out by adjusting     the ventilator. During this time, we will use the air breathed out to calculate how much     blood per minute the subject's heart is pumping. We will also measure how much blood the     heart is pumping at this time by injecting fluid into the catheter in the neck and then     drawing about 1 teaspoon of blood from the catheters in the neck and arm. We will compare the     calculated and measured values of the amount of blood pumped out of the heart for accuracy.      After we complete this procedure, we will remove the mask and allow you to rest for 10-30min.     Following the rest period, we will repeat the process and collect a second set of     measurements. We will draw a total of 4 teaspoons of blood for the study.      If you cannot comfortably breathe along with the ventilator, we will withdraw you from the     study. If you want to stop taking part in the study at any time, let the study doctor know     that you wish to withdraw. We will take off the mask, and your time in the study will end.     This decision will not affect your regular medical care.   "
223950|NCT00783692|"     The primary purpose of this study was to determine the effect of vedolizumab induction     treatment on clinical response and remission at 6 weeks and to determine the effect of     vedolizumab maintenance treatment on clinical remission at 52 weeks.   "
223951|NCT00783705|"     This randomized phase II trial is studying inositol to see how well it works compared with a     placebo in preventing lung cancer in current or former smokers with bronchial dysplasia.     Chemoprevention is the use of certain drugs to keep cancer from forming. The use of inositol     may prevent lung cancer. It is not yet known whether inositol is more effective than a     placebo in preventing lung cancer in smokers with bronchial dysplasia.   "
223952|NCT00783718|"     The primary purpose of this study was to determine the effect of vedolizumab induction     treatment on clinical response at 6 weeks and to determine the effect of vedolizumab     maintenance treatment on clinical remission at 52 weeks.   "
230274|NCT00870259|"     The purpose of this study is to examine the effect of diet-induced weight loss on the levels     of circulating nutrients and hormones which are involved in feelings of hunger and satiety.   "
223953|NCT00783731|"     Midazolam has been used in rapid sequence intubation for a long time, and the recommended     dose is 0.1mg/kg. In some studies, however, the reduced dose has been used with the concern     of hemodynamic instability. We would like to investigate that the low dose midazolam could be     used rather than the standard recommended dose, and also compare it to the etomidate,     recently used sedatives, with respect to the side effects and the easy performance of     intubation.   "
223956|NCT00783770|"     Mother's breast milk provides many benefits to babies with regard to development and improved     health. We believe the simple sugars which make up these complex sugars in breast milk and     are also found in the brain may be critical to normal brain development in term and preterm     infants.      Babies are exposed to these sugars by placental transport during pregnancy and through     mother's breast milk after they are born. For the preterm infant, we do not know if breast     milk gives enough of these sugars compared to what the baby gets during pregnancy.      A maternal blood sample and blood samples from the baby's umbilical cord will provide us with     background information for developing a supplement of special sugars that can be added to     infant formulas to provide the amount that the baby usually gets during pregnancy and from     breast milk.   "
223957|NCT00783783|"     Risperidone is an important medication used to treat children with psychiatric illnesses or     neurodevelopmental disorders, such as autism. Despite excellent symptom control, the     potential for side effects is worrisome. Treating these disorders is difficult because not     everyone responds the same way to the same risperidone dose. One reason for this is genetic     differences in how people break down the drug. Understanding these differences will help     clinicians choose a dose and better predict the response so patients will be treated     successfully with a lower risk for side effects. This study will research these genetic     differences in children with psychiatric or neurodevelopmental disorders. Hypothesis: The     inter-patient variability in risperidone pharmacokinetics and exposure, adverse events, and     clinical response in patients with psychiatric or neurodevelopmental disorders is associated     with identifiable pharmacogenetic factors, such as CYP2D6 single nucleotide polymorphisms     (SNPs).   "
223958|NCT00783796|"     To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary     Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with     ischemic heart disease due to a maximum of two de novo native coronary artery lesions in     small vessels, each in a different epicardial vessel.   "
223959|NCT00783809|"     Trauma patients are at risk for serious head trauma. The consequences of serious head trauma     are often life altering. Currently, the only method available to rapidly assess the severity     of head injury and need for neurosurgical intervention is the CT scan. This time consuming     test requires transportation of a potentially unstable patient to the CT scanner.      The investigators goal in traumatic brain injury is to identify early those patients who may     require neurosurgical intervention. Brain swelling (elevated intracranial pressure) is     transmitted to the eye and this can be measured with ultrasound. The investigators hypothesis     is that this test will rule out significant elevations in intracranial pressure and perform     as well as CT scan in doing this.      The investigators study aims to demonstrate that ultrasound of the optic nerve is as good as     CT scan in ruling out clinically significant elevations in pressure within the brain. After     consent has been obtained, any trauma patient who has an indication to undergo CT scan of the     brain will also undergo ultrasound of the eye. A radiologist will then review the CT scans to     determine if signs of elevated intracranial pressure are present. The investigators hope to     demonstrate that a bedside ultrasound performed in the trauma suite is reliable for ruling     out the possibility of elevated intracranial pressure.      **Update August 2009** Currently, deferred consent has been obtained from our REB allowing us     to defer consent for this intervention of minimal risk. As well, REB has also approved phone     consent in the interim.   "
223960|NCT00783822|"     5-10% of breast cancer patients carry a mutation in the BRCA1 or BRCA2 gene. Genetic     counseling and DNA testing are usually offered to selected patients after primary treatment     has been completed (e.g. the first year after diagnosis). For women with a mutation in one of     the two breast-ovarian cancer syndrome genes, chances of a second breast cancer are high, and     therefore a proportion of these women may opt for preventive measures in addition to their     immediate breast cancer treatment. Contralateral prophylactic mastectomy significantly     reduces this risk, and is associated with a reduction in mortality.      Genetic counseling and testing for breast cancer typically takes approximately 4-6 months to     complete. However, some hospitals and laboratories are now able to generate test results     within 3 to 6 weeks. This technology of rapid genetic testing creates new opportunities for     providing both women and their treating surgeons with information potentially relevant for     deciding between available treatment options, including type of surgery and adjuvant therapy.      The study will focus on newly diagnosed breast cancer patients who, prior to receiving     treatment, are identified as having at least a 10% risk of carrying a mutation in the BRCA1     or BRCA2 genes.      We will investigate whether women with a recent diagnosis of breast cancer make use of rapid     genetic counseling when offered.      Furthermore, we will investigate whether the process of genetic counseling (and subsequent     DNA testing) has influence on the choice of treatment, and whether and how such rapid genetic     counseling and testing (RGCT) affects levels of risk perception, cancer-related worries and     distress, and decisional satisfaction.   "
223961|NCT00783835|"     The purpose of this study is to evaluate the efficacy, safety and to assess the impact of the     treatment on quality of life of long-acting methylphenidate in adult participants with     Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a clinical condition beginning in     childhood and is characterized by inadequate levels of attention, hyperactivity and     impulsiveness.   "
230718|NCT00873704|"     The purpose of this study was to test the hypothesis that supplemental postoperative oxygen     reduces the risk of surgical wound infection in patients following lower limb vascular     surgery.   "
223987|NCT00784186|"     The primary goal of this study is to determine the clinical advantage of pre-treatment with     mifepristone in second trimester misoprostol induction abortion. This will be a randomized     controlled double-blinded trial of 260 women comparing misoprostol alone to mifepristone plus     misoprostol for second trimester (14-21 weeks' LMP) medical abortion.   "
224001|NCT00784368|"     The purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the     body, distributed within the body, and how it is removed from the body over time) of     itraconazole (ITCZ) oral solution in participants with Systemic Fungal Infection (SFI) and     those with febrile (with fever) neutropenia (FN, decrease in white blood cells) suspected of     fungal infection.   "
224002|NCT00784381|"     To evaluate the quality of orders for target drugs in old patients with impaired renal     function, hospitalized or living in long stay units, and to improve these practices by means     of a counselling system coupled to a computer prescribing system   "
223962|NCT00783848|"     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap     initiative to develop a computerized system measuring patient-reported outcomes in     respondents with a wide range of chronic diseases and demographic characteristics. In the     first four years of its existence, the PROMIS network developed item banks for measuring     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical     function, and social functioning. During the item banking process, the PROMIS network     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses     to refine the meaning, clarity, and literacy demands of all items. The item banks were     administered to over 20,000 respondents and calibrated using models based on item response     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were     developed and implemented. The network has designed a series of studies using clinical     populations to evaluate the item attributes, examine their utility as CATs, and validate the     item banks. More information on the PROMIS network can be found at www.nihpromis.org.      The purpose of this research study is to learn about the experience and impact of having     congestive heart failure (CHF). In particular, we hope to develop better questionnaires that     can measure heart failure patients' quality-of-life.   "
223963|NCT00783861|"     To demonstrate the absence of irritation potential (primary dermic irritability and cumulated     dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina (Lactic     Acid) Pocket BR.   "
223964|NCT00783887|"     Primary ciliary dyskinesia is an inherited respiratory disease caused by various functional     and ultrastructural abnormalities of respiratory cilia. The genetic heterogeneity underlying     PCD is extremely important and only few genes are clearly implicated in PCD. Their mutations     account for about 20% of patients. For all the other PCD patients, the genes responsible for     their ciliary defect remain to be identify.   "
223965|NCT00783900|"     The aim of the study is to compare the effectiviness of biatrial pacing versus intravenous     administration of metoprolol in the prevention of atrial fibrillation after cardiac surgery   "
223966|NCT00783913|"     This study will determine if electrical brain stimulation during movement practice can     improve the ability of stroke patients to reach for objects more than movement practice     alone.      People between 18 and 85 years old who have had a stroke may be eligible for this study.     Participants are randomly assigned to one of two study groups: movement training with active     (tDCS) or movement training with sham (tDCS).      Participants will undergo 1-hour movement training and (tDCS) sessions twice a day, 5 days a     week, for 3 weeks. For these sessions, subjects will sit in front of a computer screen that     shows a target (round dots) and a cursor (a line). Participants will be instructed to move     the cursor to various targets on the computer screen as fast and as accurately as possible,     controlling the position of the cursor by moving their arm, which will rest on a mechanical     device.      Participants will receive real or sham (tDCS) during the movement training sessions. For     (tDCS), electrode sponges soaked in tap water are placed on the scalp and forehead. A small     electrical current is passed between the electrodes. The stimulation lasts 20 minutes.      Patients will have the following tests four times during the study - 1) before starting     movement training 2) (tDCS) during the course of training and (tDCS), 3) after completing     training and (tDCS), 4) and 3 months after completing training and (tDCS):      Functional magnetic resonance imaging (fMRI)      Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to take pictures of     the brain. Functional MRI (fMRI) shows what parts of the brain are used when a task is     performed. For the test, the subject lies on a table that can slide in and out of the     scanner. A computer screen can be seen from inside the scanner. During the scan, subjects may     be asked to do the study task or to lie still for up to 20 minutes at a time.      Movement and function tests        -  Measurement of arm stiffness        -  Moving the arms actively and against resistance        -  Picking up objects and moving them as quickly as possible        -  Performing daily living tasks like buttoning, dressing and walking        -  Performing tasks while wearing a glove that monitors the position of the arm        -  Completing questionnaires on ability to perform daily activities or other movements and          level of tiredness      Transcranial magnetic stimulation (TMS)      TMS uses a magnet to stimulate the brain in way that is different from (tDCS). This study     us...   "
223967|NCT00783926|"     The objectives of this study are to assess the dose-related safety and immunogenicity of six     different dose levels of inactivated, Vero cell-derived reverse genetic reassortant     A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will     receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Blood will be     drawn from all subjects for serum antibody determination on Days 0, 21, 42 and 180. Body     temperature will be measured daily for 6 days following vaccination. Injection site reactions     and systemic reactions will be monitored throughout the entire 180 days of the study. Safety     data obtained at 7 days after the first vaccination for all dose levels in Cohort 1 will be     reviewed by a Data Monitoring Committee and a recommendation will be obtained whether to     proceed to the second vaccination of Cohort 1 and to the first vaccination of Cohort 2.   "
223968|NCT00783939|"     The purpose of this study is to prove the safety in normal conditions of useof the product     Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).   "
223969|NCT00783952|"     The purpose of this study is to test a new way to measure the oxygen level in the mixed     venous blood system (the system that carries blood collected from all over the body to the     heart), which is a very important monitoring tool for the overall oxygen delivery to all our     tissues. This new way measures the oxygen level in the mixed venous blood from outside the     body, instead of measuring from the inside through a catheter (a thin, flexible plastic tube)     that is placed by breaking the skin.   "
223970|NCT00783965|"     RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This randomized phase II trial is comparing two different schedules of topical     tazarotene and topical placebo to see how well they work in treating patients with basal cell     skin cancer and basal cell nevus syndrome on the chest.   "
223971|NCT00783978|"     Interstitial lung diseases (ILD) in children represent a heterogeneous group of rare and not     well defined disorders. Genetic abnormalities of surfactant proteins B (SFTPB) and more     recently C (SFTPC) have been shown to be related to these pathologies. However, variability     in the lung disease phenotype suggests the involvement of other surfactant-associated genes     such as ABCA3 (ATP-binding cassette, sub-family A, member, 3). Thus, the aim of this project     is: 1) to assess the prevalence of SFTPC mutation in children with chronic lung diseases, 2)     to precise clinical and radiological features of children with SFTPC mutation, and 3) to     identify environmental or genetic factors that may explain the extreme variability of this     disease.   "
223985|NCT00784160|"     The purpose of this study is to demonstrate the absence of irritation potential (primary     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the     product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).   "
223986|NCT00784173|"     Middle and inner ear malformations on two boys with velocardiofacial syndrome are     discussed.Special attention should be given to the presence of hearing loss due to middle and     inner ear malformations, in addition to frequent conductive hearing loss regarding mastoid     and middle ear inflammatory processes.   "
223972|NCT00783991|"     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap     initiative to develop a computerized system measuring patient-reported outcomes in     respondents with a wide range of chronic diseases and demographic characteristics. In the     first four years of its existence, the PROMIS network developed item banks for measuring     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical     function, and social functioning. During the item banking process, the PROMIS network     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses     to refine the meaning, clarity, and literacy demands of all items. The item banks were     administered to over 20,000 respondents and calibrated using models based on item response     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were     developed and implemented. The network has designed a series of studies using clinical     populations to evaluate the item attributes, examine their utility as CATs, and validate the     item banks. More information on the PROMIS network can be found at www.nihpromis.org.      This study is designed to examine how differences in modes of data capture affect     psychometric properties and score differences and to evaluate the consistency of these     results across three PROMIS health domains: emotional distress-depression, fatigue, and     physical function. Four modes of administration will be compared: interactive voice response     (IVR) technology, paper and pencil questionnaire, personal computer, and personal digital     assistant (PDA). A total of 800 patients will be enrolled from three diagnostic groups:     chronic obstructive pulmonary disease (COPD), depression, and rheumatoid arthritis. The study     will test for equivalence across modes of administration, with the hypothesis that there are     no mode effects; if mode effects are found, their magnitude across modes will be estimated.     This network project will result in an improved understanding of the effect of assessment     mode on patient-reported outcome (PRO) data. Guidance from this project can help in planning     future PROMIS activities beyond the present PROMIS program.   "
223973|NCT00784004|"     Our aim in this study is to investigate the efficiency of the breathing with different     breathing patterns. Ten volunteers and twenty patients having respiratory problems will be     coached on their breathing through specific masks which will provide four different breathing     patterns. These patterns will be 1) Breathing in through the nose only and out through the     mouth only 2) Breathing in through the mouth only and out through the nose only 3) Breathing     in and out through the nose only 4) Breathing in and out through the mouth only The data     obtained from volunteers and patients will be compared within and between the groups.   "
223974|NCT00784017|"     This multicentric phase III study is designed to assess the efficacy and safety of     recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of     children with de novo ALL   "
223975|NCT00784030|"     Polycystic kidney disease (PKD) is a genetic disease that occurs in 1 in 500 individuals and     leads to kidney failure in half of all affected. Currently, no treatments exist for PKD.     PKD-affected kidney cells divide and multiply inappropriately, and form fluid-filled sacs     called cysts. Kidney cysts continue to grow throughout life, destroying normal kidney tissue,     leading to kidney failure. Based on evidence from basic science research it is believed that     drinking high amounts of water can slow the abnormal cysts growth. This study aims to look at     changes in urine composition with high water intake in PKD-affected persons compared to     healthy individuals.   "
223976|NCT00784043|"     The purpose of this study is to evaluate and document longitudinal efficacy in young children     implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant     systems.   "
223977|NCT00784056|"     The purpose of this study is to demonstrate the absence of photoirritation and     photosensitization potential of the product Dermacyd PHDETINLYN Tangerine Mix (Lactic Acid).   "
223978|NCT00784069|"     To demonstrate the absence of photoirritation and photosensitization potential of the product     Dermacyd Breeze (Lactic Acid) Pocket BR.   "
223979|NCT00784082|"     In sickle cell disease (SCD), polymerisation of haemoglobin S and the resulting shape change     of the red blood cells (RBC) lead to vascular occlusion and severe painful crises. Permanent     inflammatory state and abnormal RBC adhesion to the endothelium trigger these phenomenon.     Hydroxyurea (HU) is the only drug that has been shown to reduce clinical severity of SCD, and     this was initially attributed to the stimulation of foetal haemoglobin (HbF). However, the     clinical response does not correlate consistently with the degree and time of HbF increment,     suggesting that HU clinical benefits may involve other mechanisms such as the induction of     natural anti-inflammatory response via the hypothalami-pituitary-adrenal axis.   "
223980|NCT00784095|"     The purpose of this study is to determine whether discussions of life story, forgiveness, and     future goals improve quality of life for patients with serious illness.   "
223981|NCT00784108|"     The purpose of this study is to evaluate native tissue optical properties and photosensitizer     optical properties in vivo with a novel, non-contact optical imaging device call Modulated     Imaging to help optimize the laser exposure in future photodynamic treatment for patients     with skin cancer.      Photodynamic therapy involves the administration of a tumor-localizing photosensitizing agent     that, when illuminated with the proper wavelength of light, can result in photochemical     processes that cause irreversible damage to tumor tissues. Photodynamic therapy is     non-invasive and has been shown to be effective in the treatment of skin cancer while     producing excellent aesthetic appearance and psychological well-being in patients that     normally would require invasive excisions.   "
223982|NCT00784121|"     To demonstrate the absence of irritation potential (primary dermic irritability and cumulated     dermic irritability) and allergy (sensibilization) of the product Dermacyd Breeze (Lactic     Acid) Pocket BR.   "
223983|NCT00784134|"     The overall objective of this Phase III clinical trial is to obtain information from a     population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of     current clinical practice and national demographics of ICH regarding the benefit (or lack     thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS).     This application requests funding for five years to initiate a Phase III randomized clinical     trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The     investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue     plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+     placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH)     and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd     or 4th ventricles by intraventricular blood clot).   "
223984|NCT00784147|"     The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered     via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to     study drug, all patients will receive an optimized background regimen (OBR), which is a     standard-of-care regimen selected by the investigator prior to randomization that is     comprised of 2-4 antiretroviral agents. These agents must have been approved by the local     regulatory agency or be available through expanded-access programs for treatment of human     immunodeficiency virus (HIV).   "
223988|NCT00784199|"     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap     initiative to develop a computerized system measuring patient-reported outcomes in     respondents with a wide range of chronic diseases and demographic characteristics. In the     first four years of its existence, the PROMIS network developed item banks for measuring     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical     function, and social functioning. During the item banking process, the PROMIS network     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses     to refine the meaning, clarity, and literacy demands of all items. The item banks were     administered to over 20,000 respondents and calibrated using models based on item response     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were     developed and implemented. The network has designed a series of studies using clinical     populations to evaluate the item attributes, examine their utility as CATs, and validate the     item banks. More information on the PROMIS network can be found at www.nihpromis.org.   "
223989|NCT00784212|"     This study will evaluate the efficacy of BGG492 in reducing the sensitivity to flashing     lights of patients with photosensitive epilepsy, using EEG as a readout.   "
223990|NCT00784225|"     RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent     cataracts or age-related macular degeneration in men receiving these drugs as part of a     clinical trial for the prevention of prostate cancer.      PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work     in preventing cataract and age-related macular degeneration in men enrolled on SELECT     (SWOG-S0000).   "
223991|NCT00784238|"     The purpose of this study is to evaluate improvement and efficacy of paliperidone     extended-release for subjective well-being and drug attitudes of participants, when switching     from oral antipsychotics in participants with schizophrenia (psychiatric disorder with     symptoms of emotional instability, detachment from reality, often with delusions and     hallucinations, and withdrawal into the self).   "
223992|NCT00784251|"     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap     initiative to develop a computerized system measuring patient-reported outcomes in     respondents with a wide range of chronic diseases and demographic characteristics. In the     first four years of its existence, the PROMIS network developed item banks for measuring     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical     function, and social functioning. During the item banking process, the PROMIS network     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses     to refine the meaning, clarity, and literacy demands of all items. The item banks were     administered to over 20,000 respondents and calibrated using models based on item response     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were     developed and implemented. The network has designed a series of studies using clinical     populations to evaluate the item attributes, examine their utility as CATs, and validate the     item banks. More information on the PROMIS network can be found at www.nihpromis.org.   "
223993|NCT00784264|"     This is an observational study to measure the thickness of artery walls in the neck (intima     media thickness IMT) by ultrasound examination in middle-aged subjects with central obesity.     The purpose of this study is to obtain local data how common asymptomatic atherosclerosis is,     and to investigate the association between Cardiovascular Disease risk factors and intima     media thickness (IMT) in the Hong Kong population. Results from this study may enhance the     public awareness of asymptomatic atherosclerosis and understand its role in the development     of Cardiovascular Disease in Hong Kong.   "
223994|NCT00784277|"     The purpose of this study is to compare bowel function/constipation that occurs during     tapentadol treatment with that occuring during oxycodone treatment, as measured by the     frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel     movements will be determined from a Bowel Function Patient Diary completed by the enrolled     sujbects.   "
223995|NCT00784290|"     The purpose of this study is to evaluate the safety and efficacy of Orantinib, an oral     tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2, platelet-derived     growth factor receptor, and fibroblast growth factor receptor, in patients with advanced     hepatocellular carcinoma (HCC).   "
223996|NCT00784303|"     The purpose of this study is to determine the safety and efficacy of oral E7080 in medullary     and iodine-131 refractory, unresectable differentiated thyroid cancers.   "
223997|NCT00784316|"     The aim of the study is to test the efficiency of intravenous administration of metoprolol     versus intravenous administration of amiodarone in the prevention of atrial fibrillation     after cardiac surgery.   "
223998|NCT00784329|"     To evaluate the potential of a new imaging device, termed Optical Frequency Domain Imaging     (OFDI), in the early diagnosing of pulmonary malignancies in the central airways.   "
223999|NCT00784342|"     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap     initiative to develop a computerized system measuring patient-reported outcomes in     respondents with a wide range of chronic diseases and demographic characteristics. In the     first four years of its existence, the PROMIS network developed item banks for measuring     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical     function, and social functioning. During the item banking process, the PROMIS network     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses     to refine the meaning, clarity, and literacy demands of all items. The item banks were     administered to over 20,000 respondents and calibrated using models based on item response     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were     developed and implemented. The network has designed a series of studies using clinical     populations to evaluate the item attributes, examine their utility as CATs, and validate the     item banks. More information on the PROMIS network can be found at www.nihpromis.org.   "
224080|NCT00785421|"     To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is     powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the     experimental arm.      N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%   "
224005|NCT00784420|"     The purpose of this study is to estimate the effect of steady state raltegravir on the steady     state pharmacokinetics of UK-453,061 and steady state UK-453,061 on the steady state     pharmacokinetics of raltegravir.   "
224006|NCT00784433|"     Moderate alcohol may be beneficial for diabetics   "
224008|NCT00784459|"     This study is designed to determine if treatment with abatacept is effective in decreasing     allergic airway inflammation in mild, atopic asthmatics. Subjects will be recruited from the     greater St Louis Metropolitan area. Eligible individuals will undergo a titrated skin prick     test. Following baseline evaluation, fiberoptic bronchoscopy with segmental allergen     challenge (SAC) will be performed. The subjects will be randomized to either placebo or     abatacept. After 12 weeks of study drug, the subjects will undergo repeat SAC. The primary     endpoint will be to determine if treatment with abatacept results in a 50% or greater     decrease in the percentage of eosinophils recovered in the bronchoalveolar lavage (BAL) fluid     following SAC as compared to placebo control. Secondary endpoints include measures of airway     obstruction and hyperreactivity, airway inflammation and symptoms as well as determination of     the safety of abatacept administration in this subject population.   "
224009|NCT00784472|"     The purpose of this study is to investigate the effect of oxynorm versus morphine after     operation for kidney stone (PCNL). In addition the relationship between pain symptoms and     referred sensory and trophic changes will be examined in the patients before and after the     operation.Finally a blood sample is analysed to investigate pharmaca-genetics.   "
224010|NCT00784485|"     The purpose of this study is to look at the effectiveness of Xolair® (omalizumab) in people     with asthma taking Advair Diskus®. The study will look at the effects of Xolair® on lung     function using high resolution computed tomography (HRCT) scans after asthma symptoms are     induced with a special substance called methacholine. This study is only taking place at     UCLA, where about 13 subjects will be enrolled. Participation requires 10-14 visits over     about 26 weeks.      Subjects will receive an albuterol inhaler to use as needed for immediate relief of symptoms     and fluticasone 250 mcg/salmeterol 50 mcg or fluticasone 500 mcg/salmeterol 50 mcg (Advair     Diskus® 250/50 or 500/50) to be taken twice daily. At certain visits, they will be given     Xolair® injections followed by various assessments, including CT scans and lung function     tests.   "
224011|NCT00784498|"     The use of procedural sedation and analgesia (PSA) to accomplish painful procedures in the     emergency department (ED) has become a standard of practice over the last decade. Substantial     variance exists regarding usage of medication for PSA, and many anesthetic agents have been     proposed for this use.      To our knowledge no head to head study compared the clinical effectiveness, safety profile     and amnestic properties of midazolam/ketamine vs. propofol regimens for PSA in the adult ED     setting.      This prospective randomized trail can will help to evaluate the effectiveness and safety     profile of Midazolam/katamine regimen for ED PSA in adults and will contribute to the     discussion regarding propofol roll in the ED.   "
224012|NCT00784511|"     North American blacks tend to have low blood levels of vitamin D because pigmentation blocks     vitamin D production in the skin. They also have higher rates of developing type 2 diabetes     and higher rates of complications from the disease compared with whites. Although there is     compelling evidence that adequate vitamin D may reduce the risk for type 2 diabetes in     whites, recent evidence from a national survey demonstrated an association of vitamin D with     diabetes in whites but not in blacks. However, the central hypothesis of this study is that     providing enough supplemental vitamin D to blacks (raising their blood levels higher than     that of most participants in the survey) will improve blood measures related to diabetes     risk. The proposed study is a 12-week randomized, double-blind, placebo-controlled experiment     designed to examine the effect of vitamin D supplementation (100 μg/d ) on insulin secretion,     insulin sensitivity and glucose control in pre-diabetic black men and women aged 40 and     older.   "
224013|NCT00784524|"     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.     Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving vaccine     therapy together with aldesleukin may be a more effective treatment for metastatic breast     cancer.      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with     aldesleukin works in treating women with metastatic breast cancer.   "
224081|NCT00785434|"     This will be an open label study of escitalopram. Patients not responsive to citalopram will     be switched directly to escitalopram.      Patients will receive escalating doses of escitalopram up to a maximum of 50 mg until they     either achieve remission (MADRS <9) or fail to tolerate the dose.   "
224014|NCT00784537|"     The purpose of this study is to define an improvement in patients:        -  To evaluate if patients resistant to the initial treatment for residual PET-positive          masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early          shift to high-dose chemotherapy supported by stem cell rescue        -  To analyse if patients achieving early complete response (PET-2 negative), can be spared          the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned          six courses of ABVD. To answer this question, PET-2 negative patients will be randomized          between radiotherapy versus no radiotherapy at the end of ABVD therapy.   "
224015|NCT00784550|"     The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR     DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA®     HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg     (TIOTROPIUM) in patients with COPD.      SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH & Co. KG.      ADVAIR DISKUS® are registered trademarks of the GSK group of companies.   "
224016|NCT00784563|"     Motivated by reported improvements in aerobic fitness and executive functions after a 6-month     aerobic walking intervention in normal sedentary elderly, we conducted a Phase I/II study to     investigate effects of aerobic exercise on motor function, cognition, and quality of life in     mild-moderate patients with Parkinson's disease (PD). To identify the best method to deliver     fitness training, we also aimed to compare safety, tolerability, and fitness benefits between     different training methods (continuous/moderate intensity vs. interval/alternating between     low and vigorous intensity) and exercise settings (individual vs. group). Interval training     reportedly facilitates higher fitness gains than continuous training. Group training may     promote success through social interaction, whereas individual training offers greater     flexibility.      Details of the study can be found in the publication below:      Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting.      Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta     S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG.      Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2.      PMID: 24991037   "
224017|NCT00784576|"     The objective of the present research is to evaluate the incidence and independent predictors     of delirium observed among patients after cardiac surgery. Moreover, to asses the sensitivity     and specificity of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition     criteria (DSM-IV) and International Statistical Classification of Diseases and Health Related     Problems - Tenth Revision criteria (ICD-10), and the cut-off values of the Memorial Delirium     Assessment Scale (MDAS) and Delirium Index (DI) in diagnosing postoperative delirium.   "
224018|NCT00784589|"     Pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5     and 10 percent depending on the severity of disease and age of patients.      The standard of care is high doses of corticosteroids (CS) (usually, prednisone, 1 to 1.5.     mg/kg/day, which are often associated with immunosuppressive drugs i.e., azathioprine,     mycophenolate mofetil, cyclophosphamide, cyclosporine, although only one randomised study has     demonstrated the superiority of the combination of corticosteroids and immunosuppressive     drugs as compared to corticosteroids alone (9). Because of the low frequency of the disease,     control trials are difficult to conduct. Evaluation of the different treatment regimens     proposed, i;e; corticosteroids alone, CS and immunosuppressive drugs, IV immunoglobulins or     new therapeutic regimens such as rituximab (an anti-CD20 monoclonal antibody directed against     B- lymphocytes) or immunoadsorbtion.   "
224019|NCT00784602|"     To prospectively observe the outcomes of surgical prolapse treatment in terms of urinary,     bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving     patient determined treatment goals.   "
224020|NCT00784615|"     Polycystic ovary syndrome (PCOS) is a very frequent endocrine disease of women in     reproductive age, with an estimated prevalence of 5 to 10 % according to the studied     population. In 2003 a committee of experts joined in Rotterdam under the auspice of the     American Society for Reproductive Medicine and the European Society for Human Reproduction     and Embryology, defined diagnostic criteria. It should include unless two of the following:     menstrual irregularities; excess of male hormones (clinic or biochemical) and polycystic     ovaries under ultrasound examination; giving rise to four subgroups or phenotypes:      1- Women with polycystic ovaries, hyperandrogenism and oligoamenorrhea . 2. Women with normal     ovaries, hyperandrogenism and oligoamenorrhea. 3- Women with polycystic ovaries,     oligoamenorrhea without hyperandrogenism. 4- Women with polycystic ovaries, hyperandrogenism     with normal menses. PCOS shares components of Metabolic Syndrome for the high prevalence of     insulin resistance (abdominal obesity, impaired glucose tolerance, type 2 diabetes,     hypertension, endothelial dysfunction, impaired lipid profile and probably cardiovascular     disease). All these findings lead us to assume that women with PCOS could have an increased     risk of developing cardiovascular disease. Nevertheless it is premature to assume that every     PCOS phenotype has the same cardiac and metabolic risk factors. So, it is important to     evaluate the endocrine and metabolic characteristic in different phenotypes of PCOS to     prevent the co morbidities that predispose to cardiovascular disease. And of course to avoid     unnecessary measures in groups that could not show increased risk.   "
224021|NCT00784654|"     The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after     administered to children and adolescents aged 6-17 with ADHD for at least 6 months   "
224053|NCT00785070|"     -  Evaluate sleep disordered breathing before and after orthopedic surgery utilizing a FDA          cleared to market (510k) home sleep study device (Nexan Inc., ClearPath System)        -  Compare Berlin Questionnaire and Epworth Sleep Scale questionnaires to the home sleep          study device results.        -  Evaluate effectiveness of the home sleep study testing in the orthopedic presurgical          population.   "
224054|NCT00785083|"     This study will evaluate the effect of FTY720 on the lung function of patients with moderate     asthma   "
224055|NCT00785096|"     The purpose of this study is to assess how patients, nurses and physicians perceive negative     events following surgical procedures.   "
224056|NCT00785109|"     In this mono-center,open,three-armes, controlled, randomized phase I study the progress of     aortic valve calcification with and without vitamin K supplementation will be investgated.     This will be done by means of measurements of concentrations from osteocalcine and MPG in     blood serum, echocardiography, cardiac computed tomography and cardiac MRI   "
224022|NCT00784667|"     This is a clinical trial investigating the effectiveness and safety of the combination of the     study drugs cetuximab and erlotinib in patients with advanced (metastatic) refractory     colorectal (bowel) cancer. If bowel cancer has spread to other organs (metastatic colorectal     cancer), it is usually incurable and life-expectancy without treatment is less then 6 months     on average. Currently, chemotherapy has been shown to have a significant impact in advanced     colorectal cancer in terms of maintenance of quality of life and extension of survival.     However, ultimately tumours will develop resistance to chemotherapy. Treatment options and     subsequent survival at that stage are very limited. Therefore, new therapeutic approaches are     urgently needed.      It is common for colorectal cancer cells to contain growth receptors, like antennae, on their     surface which regulate their growth. The drugs used in this trial have been shown to be     effective in targeting one of these growth receptors; the epidermal growth factor receptor     (EGFR). Cetuximab is an antibody (protein produced by the immune system involved in the     defense of the body against infections) against EGFR. Cetuximab has been shown to improve the     survival of patients with chemotherapy refractory advanced colorectal cancer. Erlotinib is a     protein that prevents activation and hence signaling by EGFR. Erlotinib improves survival in     patients with advanced lung cancer. Although, each of these drugs are known to be effective     at inhibiting EGFR when they are given alone, at least in some cases, it is hoped that using     two drugs that target the same receptor pathway in different ways will provide a more     effective treatment.      50 patients from four hospitals in Australia will participate in this trial, with     approximately 25 patients being enrolled at Austin Health. All participants will receive the     same treatment.      Neither of the study drugs are chemotherapy, and hence it is expected that the treatment     would be well tolerated. The most frequent side effect associated with EGFR inhibitors is     skin rash. Other possible side effects are diarrhea and low magnesium levels.   "
224023|NCT00784680|"     To compare Quality of Life between the ARIMIDEX group, the NOLVADEX group and the ARIMIDEX     plus NOLVADEX combination group during the first two years of treatment. (a) To compare the     difference in Quality of Life between the ARIMIDEX group and the NOLVADEX group (b) To     compare Quality of Life in the ARIMIDEX plus NOLVADEX combination group with the NOLVADEX     group for non-inferiority; if non inferiority is concluded, the difference in QOL between     these two groups will be assessed.   "
224024|NCT00784693|"     The purpose of this study is to determine whether tanezumab is effective and safe in the     treatment of pain associated with endometriosis.   "
224025|NCT00784706|"     The purpose of the current study is to evaluate motor and neglect recovery of stroke patients     produced by CIT using kinematic and oculomotor assessment, together with conventional     clinical measures.   "
224026|NCT00784719|"     A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in     subjects with dry eye.   "
224029|NCT00784758|"     The purpose of this study is to investigate the effects of Fenzian™ treatment on symptoms     (such as shortness of breath), lung function (how well the lungs work), and     albuterol/salbutamol (rescue medication) use in people with asthma. This will be done by     comparing the effects of Fenzian™ treatment to the effects of a sham treatment, which looks     the same as the Fenzian™ device but doesn't do anything.      The Fenzian™ device is an electrical instrument that the investigators hope will help reduce     airway inflammation associated with asthma symptoms by stimulating the nerves with very low     electrical currents. The study device will be applied directly to the skin on the back,     working along the ribs toward the spine, alternating between left and right sides, and on     your face.   "
224030|NCT00784771|"     Chronic combat-related posttraumatic stress disorder can be difficult to treat. The     investigators believe that hypnosis, with a stress on the sensation of scent which often     plays a role in the traumatic memories, can offer help for victims of this disorder who     continue to suffer after receiving other treatments.   "
224031|NCT00784784|"     This unblinded pilot study is intended to assess the feasibility of a larger double-blind,     randomized control trial. For the larger trial the investigators are interested in     understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors     for influenza infection in healthy adults, and in assessing the safety and tolerability of     seasonal antiviral prophylaxis in healthcare workers.      The pilot study will be assessing the rate of infection with influenza and the rate of     adherence to long-term zanamivir in 60 healthy volunteers.   "
224032|NCT00784797|"     Second trimester abortion can be done surgically or medically. Medical abortion with     mifepristone and misopristol is one of the common protocol, but misopristol have high rate     side effect. The investigators recent study proved the efficacy of pitocin after mifepristone     in second trimester abortion with minimal side effects.      Working hypothesis and aims: To compare misopristol and pitocin after mifepristone     preparation in second trimester in seccess rate, interval to abortion, side effects and     patient satisfaction.   "
224033|NCT00784810|"     The purpose of this study is to compare oxycodone/naloxone combination tablet and     codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or     pain due to osteoarthritis.   "
224034|NCT00784823|"     The purpose of this study is to determine the tolerance and potential efficacy of combining     dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma     undergoing autologous stem cell transplantation.   "
224035|NCT00784836|"     The primary objective of the study was to evaluate the immunogenicity of Avonex® (interferon     beta-1a) 30 mcg when administered subcutaneously (SC) to interferon-naïve participants with     relapsing multiple sclerosis. The secondary objective of this study was to evaluate the     safety and tolerability of Avonex® 30 mcg when administered SC to interferon-naïve subjects     with relapsing MS.   "
224036|NCT00784849|"     The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary     lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.   "
224037|NCT00784862|"     To assess the effect of ARIMIDEX on the pharmacokinetics of tamoxifen and the effects of     tamoxifen on the pharmacokinetics of ARIMIDEX..   "
224038|NCT00784875|"     The purpose of this study is to compare an investigational drug (LY2624803) with placebo and     with zolpidem in the treatment of outpatients with chronic insomnia.   "
224039|NCT00784888|"     The purpose of this study is to follow safety and quality of life outcomes on patients     switching from tamoxifen therapy to aromatase inhibitor therapy.   "
224066|NCT00785239|"     The purpose of this study is to create a patient registry to collect and analyze information     on subjects treated with the CryoSpray Ablation™ System post-510K approval.   "
224040|NCT00784901|"     Purpose: To study the associations between visual functions and the retinal tomography     detected by optical coherence tomography (OCT) in patients with retinitis pigmentosa (RP).      Study design: retrospective, non-randomized and non-comparable study Material: Medical     recordings of the RP patients who visited the Out-Patient Department of Ophthalmology in NTUH     during June, 2003 to June, 2008.      Methods: By reviewing charts of the RP patients, the investigators will categorize RP     patients into different types according to the loci of the pathological change in their     retina evaluated by opththaomoscopy. And the investigators will collect the data of their     visual functions including visual acuity, visual field, Arden ratio of electrooculography,     and color sense discrimination. Then, according to the OCT map, the investigators will     analyze the retinal thickness by dividing the macular area into foveal area, inner ring and     outer ring. Finally, the investigators will analyze the relationships between visual     functions and retinal thickness in different macular areas in different types of RP patients.      Anticipated results: The investigators expect that retinal tomographies may different among     different types of RP. And the retinal tomographic change may correspond to the change of a     certain kind of visual function. Hence, according to the thickness of a specific area in     macula, the investigators may anticipate that some visual dysfunction may exist.   "
224041|NCT00784914|"     RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Studying samples of blood and tumor tissue from patients with cancer     in the laboratory may help doctors learn more about how this treatment is used by the body.      PURPOSE: The purpose of this study is to evaluate the feasibility of using a microdialysis     catheter to see what effect temsirolimus has on various biological substances associated with     brain tumors over time.   "
224042|NCT00784927|"     RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the     cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help     kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as     cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide     together with rituximab, cyclophosphamide, and dexamethasone may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving lenalidomide together with     rituximab, cyclophosphamide, and dexamethasone works in treating patients with previously     untreated low-grade non-Hodgkin lymphoma.   "
244441|NCT01049269|"     The objective of this study is to validate a portable 3D human body measurement system which     will improve approaches in obesity assessment.   "
224044|NCT00784953|"     A non-interventional study to explore actual asthma control status in real-life environment     and to observe the efficacy after stepped-up to Symbicort SMART or various identical     regimens.      The study will be implemented by screening asthmatic patients from respiratory clinics to     identify those not optimally controlled and required stepping up the controllers to initiate,     or to titrate dose of, ICS/LABA including Symbicort.   "
224045|NCT00784966|"     The purpose of this study is to determine if prolonged administration of the anti TNF (tumor     necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in     patients undergoing islet after kidney transplantation.   "
224046|NCT00784979|"     The purpose of this study is to offer Panel Reactive Antibodies [PRA] reduction treatment to     high responder renal transplant patients who otherwise may never be compatible with a     potential organ donor. PRA reduction is offered in the following phases:        1. Immunological Testing        2. Transplant Nephrectomy        3. Pharmacologic Therapy        4. Plasmapheresis        5. Transplant   "
224047|NCT00784992|"     Aim of study is to investigate whether the use of silicone tubes in endonasal DCR surgery     increases the success rate and / or complication rate compared to surgery without tubes.   "
224048|NCT00785005|"     Given that sedentary behavior is associated with T2DM, the purpose of this study is to     evaluate whether subjects with T2DM have a significant disincentive to performing exercise     (due to greater perceived effort) . This study will prospectively compare the perceived     exercise effort between T2DM and non-diabetic women while adjusting for potential confounders     including baseline physical activity. This study will also assess whether perception of     effort is associated with physiologic parameters related to exercise effort. Finally, we have     3 hypothesis-generating exploratory aims designed to screen for additional psychological and     physiologic parameters that may increase perceived effort in those with T2DM.      Hypothesis 1: At the same absolute workload (e.g., 30 watts) and the same relative workloads,     it is a greater effort for women with T2DM to exercise than for non-diabetic women.      Specific Aim 1: To determine differences in subjective perceived effort of bicycle exercise     at low-to-moderate workloads in sedentary women with Type 2 Diabetes Mellitus (T2DM) vs.     non-diabetic sedentary women.      Hypothesis 2: There will be a significant association between RPE and the physiologic     measures related to work intensity (e.g., relative work intensity and tau2).      Specific Aim 2: In the same populations as SA1, to determine the strength of association     during bicycle exercise between subjective perceived effort and physiologic measures related     to work intensity.      Exploratory Aims:      Exploratory Aim 1: In the T2DM group described in SA1, to determine the strength of     association during bicycle exercise between subjective effort and additional physiologic     measures      Exploratory Aim 2: In the T2DM group described in SA1, to determine the strength of     association during bicycle exercise between subjective effort and psychologic measures     related to perception of effort.   "
224049|NCT00785018|"     Excessive inflammation is associated with tissue damage caused by over-activation of the     innate immune system. This can range from mild disease to extreme conditions such as multiple     organ failure (MOF). In marked contrast to adaptive immunity which is very sensitive to     immune modulators such as steroids, the innate immune system cannot be sufficiently targeted     by currently available anti-inflammatory drugs.      We hypothesize that C1-esterase inhibitor can modulate the innate immune response.      In this study, human endotoxemia will be used as a model for inflammation. Subjects will,     additionally to endotoxin, receive C1 esterase inhibitor or placebo. Blood will be sampled to     determine the levels of markers of the innate immune response.   "
224050|NCT00785031|"     The objective of the study is to evaluate the efficacy and cost-effectiveness of an internet     based vascular risk factor program on top of usual care compared to usual care alone for     treatment of vascular risk factors in patients at high risk for new vascular events.   "
224051|NCT00785044|"     The study was designed to study the utility of meta-iodobenzylguanidine (123I-mIBG) imaging     to identify those participants with heart failure who would experience an adverse cardiac     event during 24 months of follow-up from the administration date of 123I-mIBG in previous     studies MBG311 or MBG312.   "
224052|NCT00785057|"     This study will compare hypertension treatment pattern of stroke patients with non-stroke     patients receiving medical care from outpatient clinics at neurology specialty centers in     Korea. It will evaluate target BP achievement rate in patients with stroke compared to     patients without stroke and investigate factors affecting BP target goal efficacy in these     patients.   "
224057|NCT00785122|"     This study is being conducted in order determine whether IMA910 as single agent with GM-CSF     as adjuvant following pre-treatment with low-dose cyclophosphamide is safe and shows     sufficient anti-tumour effectiveness in patients with advanced CRC to warrant further     development. Secondary objectives of this study are investigation of immunological parameters     and additional effectiveness endpoints. Furthermore, safety, immunological parameters and     effectiveness of IMA910 as single agent with GM-CSF in combination with imiquimod following     pre-treatment with low-dose cyclophosphamide will be investigated in a 2nd cohort of     patients.      The regular study duration for individual patients in the 1st and 2nd cohort comprises     regularly 18-42 days of screening (excluding HLA-typing), 33 weeks of treatment (16     vaccinations) and 4 weeks follow-up. Thus, the period between start of screening and end of     trial is about 10 months per patient. Patients will be followed for response to subsequent     treatments (chemotherapies with or without targeted agents) and survival every 2 months after     EOS visit until death.      Patients in the 1st and 2nd cohort will be withdrawn from study treatment once a progress     according to RECIST is noted. An enrolment plan for the first 6 patients included into the     1st cohort will be part of this study to ensure maximum safety of the study participants. The     enrollment of the first 6 patients into the 2nd cohort will also follow an enrolment plan to     ensure maximum safety.   "
224058|NCT00785135|"     The purpose of this study is to demonstrate whether, in patients diagnosed with Vertical     Heterophoria, the symptoms of dizziness, headache and / or anxiety are reduced or eliminated     when a kind of correction called vertical prism is added to the patient's normal eye glass     prescription.      The experiment will involve giving the patient two pairs of glasses (one pair containing the     baseline prescription with vertical prism (Standard Treatment Glasses) and the other pair     containing the baseline prescription but without vertical prism (Placebo Glasses)) to     demonstrate which pair of glasses is most effective in reducing the symptoms of dizziness,     headache and / or anxiety in these patients.   "
224059|NCT00785148|"     To prove the safety of the gynaecological formulation in normal conditions of use.   "
224114|NCT00785863|"     In addition to alleviate pain there is growing evidence that µ-opioids enhance pain. This     problem is known as opioid induced hyperalgesia(OIH).The NMDA receptor is involved in opioid     induced hyperalgesia it may be possible to block OIH by cyclooxygenase inhibitors. This has     been demonstrated with parecoxib, a COX-II inhibitor, in a experimental pain model.Both COX-1     and COX-2 are expressed in the spinal cord. It would be of interest to investigate whether a     COX-1 preferring inhibitor like ketorolac also can reduce opioid induced hyperalgesic in this     experimental pain model.   "
244801|NCT01060215|"     The purpose of this study is to assess the effects of joint effusion on proprioceptive status     in patients with knee osteoarthritis (OA).   "
224060|NCT00785161|"     The primary aim of this study are to gather data on the real world experience of the     Penumbra System and to determine if there is a correlate between the imaging-defined size of     the ischemic penumbra at admission and patient outcome in patients already treated by the     System. This will be accomplished by the collection of all available admission imaging data     along with patient clinical and functional outcome results at 90-day follow-up to determine     if a positive association exists between these variables. A secondary aim is to collect and     summarize the 90-day functional outcome data for the purpose of sample size estimation for a     potential randomized concurrent controlled trial. This will be accomplished by collecting the     data on 90-day modified Rankin Scores (mRS) and all cause mortality.   "
224061|NCT00785174|"     Non-invasive ventilation (NIV) has become now a widely used treatment modality in ICU and     emergency services to deal with respiratory failure.1 NIV has the potential to improve     ventilatory assistance while avoiding endotracheal intubation and its complications.      Since the first publications of Meduri2 and Brochard3 the number of studies on the NIV has     been growing and developing and this technique becomes one of the major progress in the field     of respiratory assistance. Decompensation of chronic obstructive pulmonary disease (COPD) is     certainly the least questionable indication of the NIV. However, indication of the NIV is     inexorably spreading to other types of acute respiratory insufficiency, including acute     cardiogenic pulmonary edema (CPE).4 Continuous positive airway pressure (CPAP) is the most     currently used non-invasive ventilation usually performed without the use of a ventilator.     NIV using pressure support (NIPSV) combined pressure support (inspiratory aid) and positive     expiratory pressure as in CPAP. Based on physiological ground, NIPSV would be more performant     than CPAP to improve ventilatory parameters and reduce the work breathing in APE. However,     this issue is not settled yet. Number of meta-analysis over the last 2 years were devoted to     the comparison of CPAP and NISPV,5 so that the scientific evidence is still far from     established. In addition, it is not sur that patients enrolled in these studies are     representative of all patients with APE. The fact that they were included solely on the basis     of clinical criteria, the risk of overlap with other diagnoses is not negligible. Thus the     use of markers of heart failure as the BNP (brain natriuretic peptide) would be very useful.     On the other hand, the possible deleterious effect of NIPSV on myocardial perfusion is a     problem that has not been definitively resolved.      Objectives of the study:        1. Compare the efficacy and safety of the NIPSV with those of CPAP in patients presenting          to the emergency department with CPE.        2. Compare the two procedures in subgroups of patients with hypercapnia and high BNP          concentration.   "
224062|NCT00785187|"     Purpose of study: Evaluation of the affect of dose rate on UVR induced skin erythema.      Study design: A single-center, prospective, randomized, crossover, open study.      Number of patients: 20-40      Patient population: Healthy volunteers      Control: Different sites on patients body      Procedure duration: Total 3-5 hours (4 visits)      Duration of follow up: 4 days      Duration of study: Up to 6 months      Primary objectives: To examine the difference in erythemal response as a function of dose     rate, and to assess the total amount of energy that is theoretically transmitted through a     sunscreen within the range of SPF 2-10.   "
224063|NCT00785200|"     The goal of this 3-year project is to control the spread of community-associated     methicillin-resistant Staphylococcus aureus (CA-MRSA) in the Dallas County Jail. CA-MRSA is a     bacterium spreading rapidly through healthy populations and becoming an epidemic in many     regions of the U.S. Many people in the community are asymptomatically colonized by MRSA.     There have been outbreaks of MRSA infections at prisons and jails. We will study the spread     of MRSA in the jail to better understand how the bacteria are transmitted from person to     person there and how we can prevent their transmission. All detainees asked to participate     must give informed consent to do so; their privacy will be carefully protected. Detainees     with a history of allergy to CHG will be excluded. Seventeen objects in the jail will be     sampled for contamination with MRSA. Bacteria will be collected from all cultures obtained     from patients with bacterial skin infections for 18 months in a part of the jail in order to     determine how frequently these infections are caused by MRSA relative to other bacteria. A     group of about 1500 adult detainees will be tested for colonization with MRSA in order to     determine how commonly detainees carry the bacterium. A cluster-randomized 6-month study will     be undertaken among these detainees and those who take their places when they leave the jail     to determine if chlorhexidine (CHG)-containing disposable wash cloths for skin cleaning can     decrease the prevalence of MRSA skin or nose colonization. Detainees receiving CHG cloths     (about 500 detainees) will be compared to detainees receiving water-soaked cloths for skin     cleaning (about 500 detainees) or no intervention (about 500 detainees). The primary outcome     will be a difference in average colonization prevalence in detention tanks, which are     discrete detention units housing detainees, comparing the usual care to the CHG-exposed tanks     after 6 months of CHG cloth use. A secondary outcome will be a decrease in skin infections     from any cause in the tanks receiving CHG compared with usual care. All of the MRSA isolates     and a sample of the S. aureus isolates susceptible to methicillin from specimens colonizing     or infecting detainees, as well as those contaminating surfaces and objects in the jail will     be tested genetically in order to determine which strains of MRSA are present in the jail.     This study may identify ways to stop the spread of MRSA among people in jails and prisons, as     well as other places.   "
224064|NCT00785213|"     Rosiglitazone is predominantly metabolized by cytochrome P450 (CYP) 2C8. Quinine sulfate is     an inhibitor of CYP 2C8. This study will evaluate the effect of multiple doses of quinine     sulfate at steady-state on the pharmacokinetics of single-dose rosiglitazone in healthy adult     subjects.   "
224065|NCT00785226|"     Phase 1/2 dose escalation study to investigate the combination of RDEA119 and sorafenib in     advanced cancer patients.   "
224068|NCT00785265|"     The main purpose of this study is to learn which educational method is most helpful to     patients and their family members when they consider whether to pursue live donor kidney     transplantation.      Patients who are eligible for a kidney transplant usually get information in the transplant     clinic about two types of kidney transplants - one where the kidney comes from a dead donor     and one where the kidney comes from a healthy living donor. Patients are given this     information by a transplant nurse or doctor and then encouraged to discuss it with family     members and friends.      In this study, we are trying to see if changing how and where we give patients this     information makes a difference in how patients and their family members think about live     donor kidney transplantation. So, we are looking at whether getting the information in the     transplant clinic - either alone or in a group - is the same or different than getting the     same information in your home.      The study is only recruiting African American patients. This is being done because African     Americans have a higher likelihood of developing chronic kidney disease and needing a kidney     transplant than patients of other races. However, they wait longer for a kidney transplant     and die at a higher rate on the waiting list because they are less likely than other patients     to receive a live donor kidney transplant. We want to see which educational approach works     best with African American patients and their families.   "
224116|NCT00785889|"     Compared with the conventional (air) method, patients examined by the study (water) method     have lower pain scores and require less medication but have similar cecal intubation rate and     willingness to repeat future colonoscopy.   "
224117|NCT00785902|"     ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate     the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial     fibrillation during concomitant on-pump cardiac surgery.   "
224118|NCT00785915|"     This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending     dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male     and female Japanese and Caucasian subjects   "
224069|NCT00785278|"     Individuals who use a manual wheelchair depend upon their upper limbs to provide a means of     locomotion during completion of their activities of daily living. As a result of greater than     normal usage of the upper limbs, shoulder pain and pathology is common among manual     wheelchair users. Accordingly, proper wheelchair set-up may be paramount to preventing     injuries and maintaining comfort during locomotion.      The purpose of this research study is to create a subject-specific computer model of     wheelchair propulsion to provide information on wheelchair set-up (in particular, axle     placement). The primary objective of this study is to investigate the effect of wheelchair     set-up on shoulder joint forces during wheelchair propulsion; the secondary objective is to     develop a predictive model to identify differences in shoulder joint forces that result from     altering the axle position and seating set-up in user's wheelchairs.      The hypothesis of the study is that outputs from a patient-specific model will reveal that     the current axle position for each subject results in peak shoulder joint forces that are     greater than those predicted from an altered axle position (determined by the model). The     overall goal is to then adjust each manual wheelchair user's axle placement to one that     minimizes the magnitude of shoulder joint forces throughout propulsion. It is intended that     in doing so, the repetitive strain injuries associated with manual wheelchair propulsion may     be reduced, prolonging a pain-free way of life for this population.   "
224070|NCT00785291|"     This randomized phase III trial studies the side effects and how well different chemotherapy     regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV     breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized     nanoparticle formulation (nab-paclitaxel), and ixabepilone, work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Bevacizumab may block tumor growth by targeting certain cells     and slowing the growth of blood vessels to the tumor. It is not yet known which treatment     regimen is more effective in treating patients with breast cancer.   "
224071|NCT00785304|"     Thousands of soldiers, marines, and other military personnel have had injuries to the brain     due the wars in Iraq and Afghanistan. In addition, 1.5 million civilians per year in the     United States have traumatic brain injuries caused by car accidents, falls, sports-related     injuries or assaults. There are important advances in technology that we think will help us     learn a lot more about these injuries. One such advance involves new types of MRI scans that     we think will be able to show what has happened to the brain after trauma more clearly that     regular scans can. These first new scan is called diffusion tensor imaging, which shows     injury to the axons (the wiring of the brain). The second new scan is called resting-state     functional MRI correlation analysis, which shows how well various parts of the brain are     connected to each other. Importantly, the new types of scans can be done using regular     scanners that we already have in every major hospital. The innovation is entirely in how the     scanners are used and how the resulting pictures are analyzed on a computer after they have     been taken.      Our overall goal is to see whether these new MRI scans will be useful for people who have had     traumatic brain injuries. We have already tested them on some civilian brain injury patients     and found them to be very helpful. For this study, we will test them on military personnel     who have had traumatic brain injuries caused by explosions. The specific goal will be to see     if the amount of injury we see can be used to predict how well the patients will do overall     over the next 6-12 months. We think with the new scans we will be able to predict overall     outcomes better than with regular scans and other information. A related goal will be to see     whether injuries to specific parts of the brain seen by these new scans can be used to     predict whether patients will be likely to have specific problems like memory loss, attention     deficit, depression, or post-traumatic stress disorder. A final goal will be to repeat the     scans 6-12 months later to see whether the new MRI scans can show whether the injuries to the     brain have healed, gotten worse, or stayed the same.      If the study is successful, it will show that these new MRI techniques can to be used to make     earlier and more accurate diagnoses of traumatic brain injury, predictions of the sorts of     problems that are likely to occur after brain injury, and assessments of how severe the     injuries are.      This study will help traumatic brain injury patients. It will be most useful for military     personnel who have had brain injuries due to explosions. It is highly likely that it will     also be useful for younger adults who have had brain injuries due to other causes like car     accidents, sports-related concussions, falls, or assaults. It is possible that but not known     for sure whether it will help young children or older adults with traumatic brain injuries.      These new scans could help with decisions about whether military personnel can return to     duty, what sort of rehabilitation would benefit them most, and what family members should     watch for and expect. This could become used in some hospitals within 2 years, and could     become standard in every major hospital within 5 years.      The new scans could also be helpful in developing new treatments. For example, if a new drug     works by blocking injury to the axons, it would be a good idea to test on people who have     injury to their axons. Right now we have no good way to tell who these people are, and so a     new drug like this would get tested on lots of people who don't have injured axons, along     with those who do. This would make it harder to tell if the new drug is working. With the new     scans we should be able to tell who has injured axons, tell how severe the injury is, and     figure out whom to test the drugs on. It will likely take 10 years or more to develop new     drugs like this.      Further in the future, the new scans could be used to help guide surgery to implant computer     chips to help rewire the brain. We don't know how long this will take, but estimate 15-20     years or more.      Overall MRI scanning is very safe and has no known major risks. Because the scanner uses     strong magnets, anyone with metal objects in their bodies can't be scanned, as this could be     dangerous. We will make sure that no one with metal objects in their bodies is included in     the study. There can be some psychological risks involved in taking tests and answering     questions, but these are usually mild and can be managed. There is always a risk that     important confidential information will be made public and that this could have consequences.     We will do everything possible to maintain confidentiality. Nearly all of the information     will only be identified using a code number and not by the name of the person, and all of it     will be kept securely.   "
224072|NCT00785317|"     The purpose of this study is to evaluate the effects on breast in postmenopausal women     randomized to either oestradiol in combination with DRSP or E2 in combination with NETA     during six months.   "
224073|NCT00785330|"     DSHNHL R3 is a randomized clinical phase II study. The main objective is to estimate the     efficacy of rituximab as a prophylactic medication for prevention of     graft-versus-host-disease after allogeneic peripheral stem cell transplantation in patients     with a high risk relapse of aggressive B-cell Non-Hodgkin's lymphoma. The most important     secondary objective is to estimate the efficacy of allogeneic stem cell transplantation in     this clinical situation.   "
224074|NCT00785343|"     The purpose of this study is to compare standard occupational therapy to a combination of     conventional (standard) and robotic therapy. The Reo Go device will provide robotic therapy     that gives therapists a tool that could make stroke treatment faster and better by helping     patients practice more accurate arm movements with help from the device.   "
224075|NCT00785356|"     Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg     elemental iron) iron supplements twice daily.   "
224076|NCT00785369|"     The purpose of this study is to image pigmented skin lesions suspicious for melanoma with an     imaging technology called in vivo reflectance confocal microscopy. This technology uses low     intensity laser to image below the surface of the skin. The confocal images of the suspicious     skin lesion will be examined. The goal of this study is to compare the results of the     confocal image examination to the pathologic diagnosis of the skin lesion.      The technique being evaluated in this study uses reflectance confocal microscopy in vivo. The     term in vivo means in/on a living subject. In this study you will be the living subject and     the confocal microscope will be placed on your skin to look at your skin lesion. The confocal     microscope uses a weak laser light and a sophisticated lens to image the individual cells     that make up the skin. Your lesion will be photographed with high resolution photography.   "
224077|NCT00785382|"     We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate     markers postoperative pain rating scores and postoperative opioid consumption while improving     the quality of recovery following breast cancer surgery compared to placebo. The primary     outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR)     in the first 24h postoperative period. Do women undergoing breast cancer surgery with general     anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS     and a greater QoR score in the first 24 hours after their surgery than those women who     received placebo?   "
224078|NCT00785395|"     This study is designed to determine the minimum effective dose (ED90) of infusions of     oxytocin for the prevention of uterine atony / postpartum hemorrhage and the need for     additional uterotonics, in low risk parturients presenting for an elective CD.      The primary outcome measure is the response of effective uterine contraction as either     satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin     infusion dose. Secondary outcomes will include need for additional uterotonics, calculated     intra-operative blood loss and presence of oxytocin related adverse effects.   "
224082|NCT00785447|"     The purpose of this study is to find out the best way of providing artificial breathing     during cardiopulmonary resuscitation (CPR). Current standard CPR involves giving     mouth-to-mouth breathing to people requiring CPR. The rescuer pinches the person's nostrils     closed and breathes into the mouth of the unconscious person with his or her own mouth.      Some CPR studies have shown that it might be easier and more effective to breathe air into a     person's nose instead of the mouth. People receiving CPR often have blocked airways, so     breathing into the mouth does not always work.      We think mouth-to-nose breathing may be more efficient and easier to do. In this case, the     rescuer closes the person's mouth by pushing the jaw up and holding it still. Then the     rescuer breathes into the unconscious person's nose by covering the nose entirely with his or     her mouth. We are doing this study to try to find out which way works better.      We will perform both ways of breathing on people who are unconscious (asleep) before planned     (non-emergency) surgery and compare their effectiveness.   "
224083|NCT00785460|"     Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects     smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation of the     brachial artery.   "
224119|NCT00785928|"     To assess the efficacy of LY2127399 versus placebo using ACR50 response scale at 24 weeks   "
224084|NCT00785473|"     Several studies have shown that bone mineral density (BMD) at the femoral neck decreases with     increasing physical handicap (EDSS-score) in MS patients. Possible explanations are less     weightbearing exercise or less UV-exposure resulting in reduced vitamin D generation in the     skin. Prevention of osteoporosis is a high priority, because treatment of the established     disease remains sub-optimal.      We have designed a double-blind randomised controlled trial of two years' duration including     90-100 persons with MS age 18-50 to assess whether supplementation with vitamin D, given as a     weekly dose of 20,000 IU cholecalciferol, can prevent bone loss.      The primary objective of this study is to determine changes in BMD over the 2 year study     period comparing treatment and placebo groups.      The most important secondary objective is to determine cytokine profiles in blood samples. We     will also assess parameters related to vitamin D status and physical performance.   "
224085|NCT00785486|"     This is an open label non-randomized single sequence, single group two way drug interaction     study in healthy adult volunteers to determine the extent to which quinine, an inducer of     cytochrome p450 CYP 3A4, affects the pharmacokinetics of midazolam, an accepted probe drug     for CYP 3A4. The study will also determine the extent to which midazolam affects the     pharmacokinetics of quinine.   "
224086|NCT00785499|"     Milk contains a vast number of bioactive components that have been suggested to have a     positive impact on human health, of special interest is the effects related to metabolic     syndrome and obesity but the effect of the individual milk components is not clear. This     study examine whether it is beneficial for overweight and obese children to increase the     intake of skim milk, or whey or casein in relation to bodyweight and markers of MS.      The participants will be randomized to receive skim milk, whey milk drink, casein milk drink     or mineral water for 3 mo. They will be examined at baseline, end of intervention and     followed up 3 month later.   "
224087|NCT00785512|"     This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with     stage 1 or stage 2 hypertension after the withdrawal of active medication.   "
224088|NCT00785525|"     The purpose of the study is to:        -  Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood          stem cells from National Marrow Donor Program donors (NMDP) donors        -  Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis        -  Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor          hematopoietic stem cell transplant recipients        -  Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in          normal donors   "
224089|NCT00785538|"     The purpose of this study is to determine if IMC-A12 is safe for patients, and also to     determine the best dose of IMC-A12 to give to patients.   "
224090|NCT00785551|"     The effects of mild or moderate renal impairment (creatinine clearance 30 to 50 ml/min or >50     to 80 ml/min, respectively) on the pharmacokinetic profile of quinine and its active     metabolite, 3'-hydroxyquinine, will be investigated. Safety and tolerability in healthy     subjects versus those with mild to moderate renal impairment will be compared, as well.   "
224091|NCT00785564|"     A consequence of chronic RV pacing is a process of electrical remodeling that alters     myocardial repolarization to reflect the altered depolarization induced by the RV lead. When     RV pacing is discontinued, the altered repolarization persists for several weeks. This     phenomena is traditionally described as T-wave memory based upon the 12-lead ECG appearance     of inverted T-Waves. The investigators are using the ECGI technique to produce three     dimensional electroanatomical images of this phenomena in patients with dual chamber     pacemakers. Echocardiography will also be used to image the mechanical effects of RV pacing     and T-wave memory. The images will show the spatial distribution of altered repolarization     and allow us to correlate any mechanical consequences of this phenomena that may exist.   "
224092|NCT00785577|"     The purpose of this study is to test whether a new treatment will be safe and effective in     treating pain. Patients with diabetic peripheral neuropathy will be included.   "
224093|NCT00785590|"     To demonstrate the absence of photoirritation and photosensitization potential of the product     Dermacyd PHDETINLYN Sweet Flower.   "
224111|NCT00785824|"     The primary aim of this study is to obtain measures of amino-terminal telopeptides of     procollagen 1 (P1NP), a marker of bone formation, in lactating and non-lactating post-partum     African-American women both at 6-8 and at 12-14 weeks post-partum, and to compare these     values to those of normal controls. The secondary aim is to obtain at the same time points,     measurements of Parathyroid Hormone-related Protein (PTHrP), additional markers of bone     turnover [e.g. N-telopeptide of collagen cross-links (NTx), C-telopeptide of collagen     cross-links (Ctx),bone specific alkaline phosphatase (BSAP) and osteocalcin (OC)], calcium     and vitamin D metabolism in these subjects. These results will be compared with a     non-African-American cohort of post-partum women and normal controls.      The investigators hypothesize that African-American lactating women will have increased bone     turnover when compared to non-lactating postpartum women and normal controls. The     investigators further hypothesize that bone turnover is increased in lactating women     independent of race.   "
228427|NCT00845754|"     The purpose of this study is to determine if ketorolac, given after abdominal myomectomy,     will decrease the frequency of post-oerative fevers as well as improve post-operative pain     management.   "
224115|NCT00785876|"     Ankle injuries are a very common injury in children. Each year approximately 35000 kids     present to Ontario emergency departments (ED) with this problem. Right now, about 90% of     these children get x-rays of the injured ankle, even though only 12% of these x-rays show a     break in the bone. Some excellent research has created some rules that doctors can use to     help them decide which children really need x-rays. Unfortunately, even though these rules     have been proven to safely reduce x-rays by as much as two-thirds, most doctors are not using     these rules.      Therefore, this study will be the first to put the best paediatric ankle x-ray rule, the Low     Rick Ankle Rule, into physician practice in EDs. Our main goal is to determine how much we     can reduce ankle x-ray rates in EDs that use this rule regularly versus those that do not. If     we show that doctors can safely use this rule regularly and the number of ankle x-rays will     be significantly less, this will lessen unnecessary potentially harmful radiation exposure in     children, these children will spend less time in an ED, and the health care system will save     money.   "
224120|NCT00785941|"     The purpose of this study is to determine if IMC-A12 is safe for patients, and also to     determine the best dose of IMC-A12 to give to patients.   "
224094|NCT00785603|"     The purpose of the study is to examine the connection between the dose of paroxetine and the     effect of paroxetine on tramadols metabolism and thereby the effect of tramadol on the median     pupil size.      In the study 12 healthy volunteers are going through 5 phases where they are suppose to     consume a determined dose of tramadol and 5 various doses of paroxetine corresponding to the     5 phases. Fig 1.      phases 1 2 3 4 5 Dosis Tramadol mg 50 50 50 50 50 Dosis Paroxetine mg Placebo 10 20 30 50     Paroxetin / placebo 2 ½ placebo 2 placebo 1 ½ placebo 1 placebo tablets ½ paroxetine 1     paroxetine 1 ½ paroxetine 2 ½ paroxetine Fig. 1 summary of the 5 phases      There is a variation in the time where maximal plasma concentration is obtained in     consumption of respectively tramadol (1 - 2 hours) and paroxetine (6 hours). For that reason     there has to be at least 6 hours between the administration of paroxetine and tramadol.      The healthy volunteer brings the research medicine home and consumes it before bedtime the     night before the day of the study. At eight o'clock next morning the healthy volunteer     arrives to the first pupil measurement and consumption of tramadol. Tree hours later the next     pupil measurement is carried through. The healthy volunteer accumulates his or her urine     until 2 pm. As paroxetine is a irreversible inhibitor of the enzyme CYP2D6 there has to go at     least 14 days before the next phase takes place. In that amount of time there can be     recreated a new pool of enzyme.   "
224095|NCT00785616|"     This study will enroll completers of a prior 24 week MEMS cap study of Kaletra adherence,     conducted in 2005 - 2006, and repeat the MEMS monitoring for an additional 24 weeks in     2008/2009 on the current antiretroviral anchor drug. The goals of the study are to correlate     long-term adherence with virologic outcome, and to explore the stability of MEMS cap     adherence measurements over time.   "
224096|NCT00785629|"     The purpose of this study is to determine the ability of 3 commercially available phosphorus     binders (calcium acetate, sevelamer carbonate, and lanthanum carbonate) to achieve and     maintain a phosphorus level in the normal range in patients with chronic kidney disease.   "
224097|NCT00785642|"     To prove the safety of the gynaecological formulation in normal conditions of use.   "
224098|NCT00785655|"     To demonstrate the absence of irritation potential (primary dermical irritability and     cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd     PHDETINLYN Sweet Flower.   "
224099|NCT00785668|"     This is a single centre, single dose pharmacokinetic/safety study in male and female     asthmatic subjects. Subjects will receive a single dose of 10 mg of AER 001 administered as a     dry powder using a handheld device. The goals of this study are to understand the     pharmacokinetics and safety of AER 001 administered as a dry powder in mild to moderate     asthmatics.   "
224100|NCT00785681|"     The purpose of this study is to demonstrate the absence of irritation potential (primary     dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of     the product Dermacyd PHDETINBACK Sweet Flower.   "
224101|NCT00785694|"     This is a randomised, comparative, multicentre study to determine if the early recurrence     rate of intermediate-risk bladder cancer is similar in subjects treated with multiple     instillations of mitomycin C after resection conducted under white light cystoscopy (group A)     and subjects treated with 1 instillation of mitomycin C after resection conducted under white     light and blue light cystoscopy (group B).   "
224102|NCT00785707|"     The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory     behavior in children during the first two (hearing) years. The questionnaire has been     validated on children with normal hearing whose native language is German. A comparison was     made between North American English speaking children with normal hearing and found that it     was consistent with the German data. This study is to validate the questionnaire in children     with cochlear implants.   "
224103|NCT00785720|"     The purpose of this study is to demonstrate the absence of photoirritation and     photosensitization potential of the product Dermacyd PHDETINBACK Sweet Flower.   "
224104|NCT00785733|"     The primary objective of this non-interventional study is to evaluate efficacy of Symbicort®     SMART treatment in adult patients with moderate to severe asthma using ACQ scores during 6     months period   "
224105|NCT00785746|"     The objective of this pilot study is to estimate, for a frail elderly population, the extent     to which balance improves following a Core-Strength training program in comparison to a     Stretch & Strength program. A secondary objective is to explore the impact of core strength     training on urinary incontinence.   "
224106|NCT00785759|"     Study to Assess Brain Uptake and Safety of AH110690 (18F) Injection in Subjects with Probable     Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers.   "
224107|NCT00785772|"     The primary objectives of this study are to evaluate the pharmacokinetics (PK) following     administration of gabapentin in Japanese epileptic patients with renal impairment to confirm     if there are any clinically relevant differences between the plasma gabapentin concentration     simulated by population PK model, which was used for the evidence of the dose adjustment for     the patients with renal impairment, and observed plasma gabapentin concentration.   "
224108|NCT00785785|"     This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients     with unresectable or metastatic gastrointestinal stromal tumors (GIST).   "
224109|NCT00785798|"     The study will be a dose-finding, phase I study of the combination of vorinostat and PLD in     patients with advanced lymphoma refractory to at least one prior systemic therapy. The study     will also be a dose-escalating study of vorinostat 200mg to 400 mg twice daily for 7 days     with PLD 30mg/m2 on day 3 every 21 days, with intrapatient dose escalation.   "
224110|NCT00785811|"     The primary purpose of this study is to evaluate the effect of oral administration of     L-arginine in the muscular fatigue of the quadriceps, expressed in terms of the Fatigue     Resistance Factor (FRF). The secondary purpose of this study is to evaluate the effect of     oral administration of L-arginine in the muscular force the quadriceps.   "
224112|NCT00785837|"     Researchers suggest that the protection of the cycles of sleep is essential for     neurodevelopment, learning, memory and preservation of brain plasticity to the individual's     life. Recent research shows that technical bath promote reduction of crying, anxiety and     improves the behavior of newborns.   "
224113|NCT00785850|"     To prove the safety in normal conditions of use.   "
224121|NCT00785954|"     The purpose of this study is to determine whether KAI-9803 is safe and effective in reducing     infarct size in subjects with ST elevation myocardial infarction (heart attack) undergoing a     percutaneous coronary intervention (PCI). A select number of sites will also participate in a     substudy where eligible patients will undergo an additional procedure;cardiac magnetic     resonance imaging.   "
224122|NCT00785967|"     Hypothesis: Treatment with raltegravir does not alter V(D)J recombination or immune responses     to neoantigens.      A process known as V(D)J recombination is essential for developing lymphocytes and the     specific functioning of the immune system. Raltegravir is the first approved drug of the new     integrase inhibitor class of anti-HIV drugs. Integrase inhibitors have been shown in some     studies to interfere with DNA cleavage and the activities of RAG-1/2. These studies suggest a     potential to affect aspects of both B-cell and T-cell development, therefore, it is important     to evaluate the potential effects that integrase inhibitors may have in clinical use. If     immunoglobulin and T-cell receptor genes are altered by HIV integrase, then patient     lymphocytes will fail to display normal responses to vaccinations.   "
224123|NCT00785980|"     Ciprofloxacin is moderate inhibitor of cytochrome P450 1A2 (CYP1A2), one of the enzymes     responsible for the metabolism of quinine. This study will evaluate the effect of     ciprofloxacin-related inhibition of CYP1A2 on the pharmacokinetics of quinine sulfate.   "
224124|NCT00778973|"     The purpose of this study was to evaluate the relative bioavailability of the test     formulation of sertraline 100 mg tablets with an already marketed reference formulation     Zoloft® 100 mg tablets (Pfizer), under non-fasting conditions in healthy male and female     adult subjects.   "
224125|NCT00778986|"     The purpose of this randomized controlled trial is to determine the effects of a user-centric     remote patient monitoring system on heart failure management. Patients attending a Heart     Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. The     hypothesis is that the remote monitoring system will improve heart failure outcomes through     increased self-care and improved clinical management.   "
224126|NCT00778999|"     The success of assisted reproductive technologies (ART) is critically dependent on optimizing     protocols for controlled ovarian stimulation to provide adequate numbers of good quality     oocytes and embryos. This optimization is mainly valuable to a group of infertility patients     (9%-24%) who respond poorly to Controlled Ovarian Stimulation(COS). It is also important for     an additional 2.6% of the infertility patients who manifest a high response to gonadotropin     and are at risk for hyperstimulation syndrome, a life-threatening situation. Extensive     research was carried out and led to the introduction of GnRH antagonist, as an alternative to     Gonadotropin Releasing Hormone (GnRH) agonist, for the prevention of premature Luteinizing     Hormone (LH) surges. Further research to optimize the GnRH antagonist regimen concluded that     a daily treatment with 200 IU of recombinant Follicle Stimulating Hormone (recFSH) in a GnRH     antagonist regimen is safe, well tolerated and results in a good clinical outcome. This     protocol is now frequently applied in the US and Europe.      Predicting a woman's response (based on the assessment of ovarian reserve) to COS is useful     in determining individualized clinical management strategies for low and high responders and     thus avoiding cancellation. Such prediction when based on reliable scientific evidence is     valuable in consulting patients about their chances of success. A large number of studies     have been performed, which used certain clinical, ultrasonographic and hormonal markers     (called predictive factors), to try to optimize a COS protocol for patients who were     down-regulated with a long GnRH agonist protocol. Prospective trials of predictive models     have also been used to adjust the starting dose of FSH to prevent a too low or too high     ovarian response. To date, however, none have been performed for women undergoing ovarian     stimulation with a GnRH antagonist protocol.      The primary objective of this randomized, open-label, multicenter clinical trial was to     identify one or more factors capable of predicting ovarian response in women treated with a     daily dose of 200 IU recFSH in a GnRH antagonist protocol. Since many ART centers now use     oral contraceptives as a means to schedule patients stimulated with recFSH and a GnRH     antagonist for assisted reproduction, the trial evaluated also whether intervention with oral     contraceptives affects the accuracy of predictive models for ovarian response.   "
224127|NCT00779012|"     The objective of this study is to prove reasonability of registration in Russian federation     this new indication (ankylosing spondylitis [AS]) through evaluation of safety and efficacy     rate of Remicade 5mg/kg, given as an intravenous infusion over a 2-hour period followed by     additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to     8 weeks (maximum 9 infusions).   "
224129|NCT00779038|"     The purpose of this study is to evaluate in daily clinical practice the safety and efficacy     of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of     moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe)     pain in participants who have undergone elective spine or orthopedic (related to bones)     surgery.   "
224130|NCT00779051|"     The study compared the relative bioavailability (rate and extent of absorption) of 10 mg     Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg Ambien® tablets distributed by     Sanofi-Synthelabo, Inc. following single oral dose (1x10 mg tablet) in healthy adult     volunteers administered under fasting condition   "
224131|NCT00779064|"     This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety     of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).   "
224132|NCT00779077|"     We wish to measure the inspiratory flow and volumes generated by the subjects inhaling from a     spirometer with a high resistance dry powder inhaler in series in subjects with cystic     fibrosis.   "
224133|NCT00779090|"     In ventilated patients open endotracheal suctioning may lead to alveolar derecruitment, which     can be monitored by means of functional residual capacity (FRC) measurements. The     investigators hypothesized that a recruitment strategy based on FRC measurements would     improve oxygenation and regional ventilation after an open endotracheal suctioning manoeuvre.   "
224134|NCT00779103|"     The purpose of this study is to follow and collect additional medical and developmental     information on children after histrelin subcutaneous implant therapy is discontinued.   "
224135|NCT00779116|"     This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab     2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg      Chewable Tablet). Subject preference for one product or the other was determined.     Acceptability of product attributes (Taste and Feeling in the Mouth) was rated using a     smile face scale.   "
224136|NCT00779129|"     Women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin     or epirubicin) but cardiac toxicity limits their use. The aim of this study is to evaluate     the safety and efficacy of Caelyx in combination with cyclophosphamide in women with     metastatic breast cancer who have received adjuvant anthracyclines with or without a taxane.   "
224155|NCT00779376|"     The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy     and GlaxoSmithKline (Retrovir ®) 300 mg Zidovudine tablets, under fed conditions   "
224137|NCT00779142|"     It is well known that blindness is one of the most feared disabilities expressed by patients     in the United States. Estimates of the economic impact of visual disability in the current     population exceed 30 million US dollars in this country alone. The reasons for this figure     are many; however age related macular degeneration (ARMD), diabetic retinopathy, glaucoma and     uveitis are responsible for the majority of permanent visual disability and hence the costs     in both quality of life and placing an economic burden on society. Research that may help     reverse various abnormal biological responses that lead to or worsen clinical manifestations     of diabetic retinopathy would be valuable.   "
224138|NCT00779155|"     The purpose of this study is to determine if low level magnetic fields may help to relieve     symptoms of Parkinson's disease.   "
224139|NCT00779168|"     RATIONALE: White button mushroom extract may stop or delay the development of recurrent     prostate cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of white button     mushroom extract in treating patients with recurrent prostate cancer after local therapy.   "
224140|NCT00779181|"     The purpose of this study is to determine a safe and effective dose of ADX415 for the     treatment of hypertension.   "
224141|NCT00779194|"     Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown origin. It involves     multiple organs including the joints, skin, kidneys and central nervous system. The disease     process is caused by a dysfunction of the immune system. The drugs currently used for the     treatment of SLE are only partially effective and carry significant risks for side-effects.     Rapamycin, also called sirolimus or Rapamune, has been approved by the FDA to prevent     rejection of organ transplants at daily doses of 2 mg to 8 mg. Patients that were resistant     or intolerant to conventional medication have been effectively treated with Rapamycin and     were able to decrease the amount of prednisone they needed.      The purpose of this study is to prospectively determine the therapeutic efficacy and     mechanism of action of Rapamune in patients with SLE. Healthy subjects not receiving Rapamune     will be asked to donate blood to serve as controls.      As part of the research effort to understand the reason for the variations in the effects of     treatment drugs by different individuals, a sub-study of the DNA makeup of subjects enrolled     in the trial will also be done. The purpose of the sub-study is to possibly determine whether     different responses to the drugs used to treat SLE have a correlation with the differences in     the genetic makeup of the subjects.   "
224142|NCT00779207|"     The purpose of this study is to determine the effect of weight loss and exercise on liver and     muscle fat.   "
224143|NCT00779220|"     This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in     combination with methotrexate（MTX）in patients with active rheumatoid arthritis (RA). The data     from this study will also be compared with those from a clinical study of ocrelizumab in     patients with active RA that was conducted in the U.S.   "
224144|NCT00779233|"     The purpose of this study is to evaluate the relative bioavailability of the test formulation     of Zidovudine 300 mg tablets with an already marketed reference formulation RETROVIR ® 300 mg     tablets (GlaxoSmithKline), under fasted conditions in healthy male and female adult subjects.   "
224145|NCT00779246|"     This pilot study in our medical intensive care unit will evaluate the clinical and     cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus     aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate     (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisition, and of other     hospital-acquired infections (e.g., catheter-associated bloodstream infections).   "
224146|NCT00779259|"     In a prior in vitro study using human hepatocytes quinine was shown to induce the activity of     Cytochrome p450 CYP 1A2. The present study will evaluate the extent to which quinine     sulfate-related induction of this enzyme effects the pharmacokinetics of theophylline, a     sensitive probe drug for the activity of CYP 1A2. It will also evaluate the effect of     single-dose theophylline on the pharmacokinetics of steady-state quinine sulfate.   "
224149|NCT00779298|"     Increased intake of dietary fibre and whole grains is related to reduced risk of developing     diabetes. The term whole grain is often used for whole-meal products in which the structure     of the cereal grain is destroyed in the flour containing the original dietary fiber, but also     for cereal products in which a large proportion of whole cereal grains is intact. The aim of     this study was to evaluate the effect of commercial rye whole-meal bread (RWMB) compared to     white-wheat bread (WWB) on gastric emptying rate (GER), postprandial glucose response in     healthy subjects.   "
224150|NCT00779311|"     This research study is being performed at approximately 3 sites associated with Accelerated     Community Oncology Research Network, Inc. (ACORN). Approximately 45 subjects will take part     in this study.      In this study, everyone will receive the same dose of mFOLFOX6 and Avastin. There will be     five groups of subjects. Each group of subjects will receive a higher dose of Nexavar than     the previous group. This will continue until a subject group has a major side effects from     the dose they are given. This is so that the sponsor can determine the highest dose of     Nexavar that can be used with mFOLFOX6 and AVastin (this is called the maximum tolerated dose     or MTD).   "
224151|NCT00779324|"     The purpose of this study is to study the effect of amantadine on irritability and aggression     caused by traumatic brain injury.   "
224152|NCT00779337|"     This trial will use a new method of treating lymphoma using a therapy derived from a person's     Killer T cells. These Killer T cells are taken from a person's blood and grown in a test tube     to increase the number of these cells that are specifically active against the lymphoma     cells. The cells are then given to the patient by intravenous infusion with the aim of     killing the lymphoma cells. Potentially this treatment will help to kill the     residual/recurrent tumour that is present after other lymphoma treatment and reduce the     chance of the tumour recurring.   "
224153|NCT00779350|"     The purpose of this study was to evaluate the relative bioavailability of the test     formulation of sertraline 100 mg tablets with an already marketed reference formulation     Zoloft® 100 mg tablets (Pfizer), under fasted conditions in healthy male and female adult     subjects.   "
224154|NCT00779363|"     The objectives of this feasibility study are to evaluate the safety and functionality of the     TANTALUS System with TANTALUS II IPG, to assess the effect of GCM signal application on     trends of HbA1c, blood glucose and body weight changes.   "
224157|NCT00779402|"     The PROTECT-PROvenge Treatment and Early Cancer Treatment trial is a Phase IIIB trial for     patients with hormone sensitive prostate cancer. The study is being conducted at over 15     participating centers throughout the US. The purpose of the study is to determine if Provenge     is effective for treatment of early stage, non-metastatic prostate cancer. If you have rising     PSA after radical prostatectomy, but have no evidence yet of metastasis, you may be eligible.     The study compares the active vaccine to placebo (your dendritic cells that were not     activated in the laboratory) to determine whether the product delays the time until the     cancer progresses.   "
224158|NCT00779415|"     Patients diagnosed with partial thickness tears of the rotator cuff are sometimes surgically     repaired, while other cases are not. It is unknown how patients fare over time without     electing surgical repair and how outcomes differ by type of injury.   "
224159|NCT00779428|"     The primary purpose of this study is to provide treatment to patients who have participated     on a prior protocol investigating Tanespimycin (KOS-953,17-AAG)   "
224160|NCT00779441|"     The study compared the relative bioavailability (rate and extent of absorption) of 10 mg     Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg AmbienÂ® tablets distributed by     Sanofi-Synthelabo, Inc. following single oral dose (1x10 mg tablet) in healthy adult     volunteers administered under non-fasting conditions   "
224161|NCT00779454|"     The purpose of this study is partly to continue the good experience the investigators have     with chemotherapy and partly to optimize treatment of inoperable cholangiocarcinoma by adding     a biological antibody to the treatment of patients with wild-type Kirsten rat sarcoma viral     oncogene homolog (KRAS).   "
224162|NCT00779467|"     The purpose of this study is to see which dose of epidural neostigmine is the best additive     to use with the numbing medication used in an epidural during labor.   "
224163|NCT00779480|"     To determine the maximum tolerated dose of KW-2449 in people with acute myelogenous leukemia     who are not candidates for approved therapy. As well, the study will determine the response     rate to KW-2449.   "
224164|NCT00779493|"     Evidence exists to support low-grade inflammation as the inciting factor leading to visceral     hypersensitivity and alteration in motility in irritable bowel syndrome.In the medical     literature,there is ample in vitro and in vivo evidence supporting turmeric and its     derivative curcumin as an antitumor, anti-inflammatory and antioxidant agent. We propose a     randomized, placebo-controlled, double blinded, parallel treatment study evaluating the     effects of turmeric on the symptoms of irritable bowel syndrome.   "
224165|NCT00779506|"     This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy     and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment     of acute schizophrenic patients. The eligible patient will be assigned to study treatment     with Quetiapine XR on Day 1.      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation     was changed to XR after consultation with FDA.   "
224166|NCT00779519|"     Multiple pathways including peripheral and central hormones and neurotransmitters are     involved in the regulation of food intake and body weight. One of the most studied pathways     involves the melanocortin receptor. Agouti-related protein (AgRP) and alpha-melanocyte     stimulating hormone (alphaMSH)have been shown to play an integral role in food intake and     body weight.      It is reasonable to speculate that if there is an imbalance of alphaMSH and AgRP exist in     obese individuals and inhibiting the activity of AgRP may be of therapeutic benefit in     treating obesity.   "
231220|NCT00879021|"     This research study will test to see if people who receive pregabalin after their spinal cord     injury will develop less nerve damage pain than people who do not receive it.   "
224167|NCT00779532|"     The trial is a single-center randomized, double-blind, double-dummy, placebo and positive     controlled, parallel group clinical trial.      This trial investigated whether NOMAC-E2 (Org 10486 -0 + Org 2317), a new combined hormonal     contraceptive, has potential to delay cardiac repolarization. The primary measure of cardiac     repolarization in this trial is the Fridericia corrected QT interval (QTcF). QTcF represents     the duration of ventricular depolarization and subsequent repolarization. A delay in cardiac     repolarization creates an electrophysiological environment that favors the development of     cardiac arrhythmias, most clearly torsade de pointes (TdP), but possibly other ventricular     tachyarrhythmias.      The primary aim of this study is to investigate, if the administration of a therapeutic     (2.5/1.5 mg) or supra-therapeutic (higher than required for treatment: 12.5/7.5 mg) dose of     NOMAC-E2 administered over a period of 14 days will prolong the mean QTcF interval to values     above the accepted threshold of regulatory concern.      In addition, a single dose of moxifloxacin will be administered in order to prove that     sensitivity of the applied assay is sufficient to detect the prolongation of the     QTcF-interval.      Secondary aims of this study are to evaluate the relation between concentrations of NOMAC     (therapeutic and supra-therapeutic) after steady state has been reached in the subject's     body, the time matched change in Estradiol E1 and E2 in relation to baseline and the QTcF     intervals after multiple dose administration of NOMAC-E2.      Finally, the safety and tolerability of different treatments are investigated.      A total of 189 subjects will participate in this trial. The entire study duration is about 9     weeks with a 4-week screening period, 14-day treatment period and a follow-up period of about     3 weeks.   "
224168|NCT00779545|"     This is a multicenter, randomized, double-blind within the dose level, parallel group     comparison of mometasone furoate nasal spray in subjects with perennial allergic rhinitis to     examine the minimal effective dose, the recommended dose, and the dosing regimen.   "
224169|NCT00779558|"     Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac     patients. It remains unclear if a heparin infusion, compared to a normal saline infusion,     prevents thrombosis of CVCs after surgery. This study will answer the question: does a     low-dose heparin infusion (10 units/kg/h) prevent thrombosis, compared to a normal saline     infusion, in patients less than one year of age after cardiac surgery?   "
224170|NCT00779571|"     This study has two phases:        1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on          manifestations of PCOS, including risk factors for the metabolic syndrome and          cardiovascular risk profile will be compared.        2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above          mentioned parameters will be compared and evaluated.   "
224171|NCT00779584|"     This study of MK-8776 (SCH 900776) will evaluate its safety and tolerability when given as     monotherapy or in combination with gemcitabine to participants with advanced solid tumors or     lymphoma. Participants will be enrolled in cohorts that will receive sequentially higher     doses of MK-8776 in combination with standard doses of gemcitabine The recommended     combination doses for a Phase 2 trial (combination-RP2D) will be determined based on safety     and biological activity. Up to 10 to 15 additional participants may be studied at the     combination-RP2D.   "
224172|NCT00779597|"     This study will test the SCION (Self care improvement through oncology nursing)-PAIN program,     a multi-modular structured intervention to improve self management in oncologic patients with     pain compared to care as usual (standard pain treatment and standard care). The study will     determine if the self management skills of the patients continue to be used when the     intervention stops, e.g. after discharge from hospital.      It is hypothesized that patients who receive the multi-modular structured intervention will     have less patient-related barriers to the management of cancer pain.   "
224173|NCT00779610|"     This pilot study is designed to analyze the effects of Vibration Therapy (VT) on grip     strength and level of forearm contraction by measuring hand grip dynamometry and surface     Electromyography (sEMG) using the BioPac sEMG and digital dynamometry devices after the     application of both passive and active Vibrational Therapy (VT) using the PowerPlate.   "
224174|NCT00779636|"     This was a placebo controlled study designed to evaluate the effectiveness of desloratadine     in relieving symptoms of allergic airway disease during the pollen season. Patients received     desloratadine 10 mg or placebo once daily for 28 days, and had their allergy symptoms and     side effects to medication measured on Day 1, Day 15, and Day 29 (one day after stopping     study drug).   "
224175|NCT00779649|"     A properly prepared colon is vital to the success of any colonoscopy. The purpose of this     study is to determine which colon prep, MoviPrep or HalfLytely is the superior prepping     agent.   "
224176|NCT00779662|"     This study is an epidemiological observational cross-sectional study designed to estimate the     prevalence of echocardiographically confirmed RHD in school children from 5-14 years of age     in Fiji. The study will be conducted in the Central Division of Fiji within a selection of up     to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions. School     children will be enrolled after informed consent has been obtained. A standard cardiac     examination (auscultation) will be performed as part of the routine annual health check by     both school nurses, who have attended a training workshop, and by a paediatrician. All     children with or without murmur will have a screening echocardiogram performed at a     subsequent visit. Children found to have possible, probable or definite RHD or other cardiac     pathology on the screening echocardiogram, will have a full echocardiogram performed by the     echocardiography technician at the time of the second study visit. They will all also be     referred to a paediatric cardiologist for further investigation and management and monitoring     . Cases of RHD will be referred to and followed up by the National Fiji RHD register based at     CWMH in Suva.   "
224177|NCT00779675|"     This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study     of infliximab in participants with plaque-type psoriasis to assess the clinical response in     real-world practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a     psoriasis population, prescribed in a regimen in accordance with the product monograph (PM)     for Canada, the approved summary sheet of product characteristics (SPC) for countries in the     European Union (EU), or per label according to local guidelines for all other participating     countries.   "
228441|NCT00846053|"     The purpose of this research is to determine how a person's lungs will uptake     [18F]fluorodeoxyglucose (FDG), as measured with positron emission tomography (PET) scanning     in young cystic fibrosis patients.   "
224178|NCT00779688|"     This registry will collect data from patients routinely undergoing an ERCP and Cellvizio     endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due     to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy     images collected using the marketed Cellvizio device may help endoscopists more accurately     diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected     lesion is malignant or benign.   "
224179|NCT00779701|"     Glycemic control can be safely achieved in surgical and medical intensive care unit settings     and has been shown to improve short and long-term clinical outcomes. As such, insulin     infusion protocols are routinely used in the ICU setting. The investigators plan to establish     the use of strict glycemic control in a heterogenous group of acutely ill patients in the ED     setting. The investigators propose to study the aspects of implementing a strict glycemic     control protocol in the ED.   "
224180|NCT00779714|"     This phase III trial is aimed to investigate the efficacy of an individualized,     sensitivity-directed combination chemotherapy in comparison to the standard regimen DTIC.      Two question are aimed to be answered by this study:        1. Is the individual chemosensitivity index (BICSI) a prognostic / predictive biomarker for          chemotherapy ?        2. Is an individualized, sensitivity-directed combination chemotherapy superior to the          standard regimen DTIC in terms of survival and response ?   "
224181|NCT00779727|"     Randomized controlled trial assessing the benefit of cesarean wound drainage in pregnant     women at increased risk of hemorrhage. The pregnant women at increased risk of hemorrhage     were randomised in two groups. In one group 2 wound drainages were placed during the cesarean     section, in the other group none. Outcome measures were difference between preoperative and     postoperative hemoglobin, postoperative fever, cumulative opiate dose adjusted to body     weight, length of stay and operation time. It is postulated that the pregnant women with     increased risk of hemorrhage do not profit from the routine placement of wound drainages.        -  Trial with surgical intervention   "
224182|NCT00779740|"     This is a multicenter, open-label, randomized, parallel group comparison study to verify the     clinical equivalency of the old formulation (50 mcg as mometasone furoate [MF] in 50 μL of     solution per spray) to the new formulation (50 mcg as MF in 100 μL of solution per spray) in     patients with perennial allergic rhinitis.   "
224183|NCT00779753|"     The purpose of this study is to establish the parenteral lysine requirements for neonates.   "
224541|NCT00797693|"     The purpose of this study is to determine whether oral versus vaginal misoprostol is     effective in termination of first trimester missed abortion and to compare between two     different routes.   "
224184|NCT00779766|"     This is a multicenter study in which women are planned to receive either the HPV vaccine or     control. Study participation will last approximately 72 months and involves a total of     thirteen or fourteen scheduled visits.      Originally, the study was planned for 24 months. It was then extended for 2 more years with 4     additional visits (study end at Month 48).      The protocol posting has been updated as the study will be extended by additional 2 years     with two or three additional visits (study end at Month 72) for subjects who consent to     participate in the extension.   "
224185|NCT00779779|"     This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use     of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than     24 weeks (second dose).   "
224186|NCT00779792|"     The purpose of this study is to compare the efficacy of glycerol ointment, triamcinolone     acetonide ointment, clobetasol ointment and tacrolimus ointment on irritated skin in a     cumulative skin irritation test model using healthy volunteers.   "
224187|NCT00779805|"     The objective of the study was to compare the single dose oral bioavailability of     Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy with Sudafed 120 mg ER tablets of     Pfizer Consumer Health Care in healthy, adult, human subjects under fed conditions.   "
224188|NCT00779818|"     This is a treatment for low back pain using electrical stimulation and laser for 6 weeks.   "
224189|NCT00779831|"     Compare bioavailability of Pseudoephedrine hydrochloride extended release tablets (Ranbaxy     Laboratories Limited) against reference product Sudafed ® 12-hour tablets 120 mg     (Warner-Lambert) under fasting conditions.   "
224190|NCT00779844|"     Pharmacokinetic models for anesthetic agents are questionable. The objective of the study is     to compare the propofol and remifentanil doses required to maintain the bispectral index in     the range 40-60 in two groups of patients: obese patients and lean patients   "
224191|NCT00779857|"     Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion     Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.   "
224192|NCT00779870|"     Our hypothesis is that the severity of asthma is determined by the way in which airway smooth     muscle cells grow and release inflammatory mediators. Our main objective is to establish how     the properties of the airway smooth muscle cell varies with asthma severity. Environmental     agents, such as cigarette smoke, and inflammation can give rise to oxidative stress - this is     a process whereby harmful chemicals called free radicals are formed in the body and damage     tissues. The damage caused can be limited/prevented by protective, or anti-oxidant mediators.     We will also look at molecules involved in oxidative stress which may affect the way in which     the airway smooth muscle grows and produces inflammatory mediators.   "
224193|NCT00779883|"     The study is a Phase I, dose-escalating, non-randomized, single institution clinical trial     assessing the safety and efficacy of autologous Ad-ISF35-transduced CLL B cells administered     as a single intravenous infusion in patients with chronic lymphocytic leukemia (CLL).   "
224194|NCT00779896|"     This is an open label, prospective study to evaluate therapeutic potential of Tazarotene 0.1%     cream for the treatment of Stage I-IIA CTCL. Patients with Stage I-IIA disease are enrolled     into the study. Tazarotene will be used for up to 24 weeks and patients will be followed for     up to 12 months.   "
224208|NCT00780091|"     OPTIMON will compare the efficacy and the cost of two monitoring strategies: one based on the     classic standards of quality assurance, and the other one being a priori optimized on the     main scientific and regulatory principles.   "
224209|NCT00780104|"     The purpose of this study is to evaluate the side effects of sirolimus (rapamycin) given in     combination with chemotherapy (Mitoxantrone + Etoposide + Cytarabine (MEC)) on high risk     myeloid leukemias.   "
224210|NCT00780117|"     Contribute to support hypothesis of relationships between genes involve in oncogenesis and     those involve in embryological development.   "
224195|NCT00779909|"     The burden of chronic gingivitis and periodontitis in the US is disproportionately high among     Non-Hispanic Blacks compared to Non-Hispanic Whites. Chronic gingivitis is a highly prevalent     chronic inflammatory disease that may progress into periodontitis, a major cause of tooth     loss, Data from in-vitro and animal studies suggest anti-inflammatory effects of vitamin D;     however, if and over what dose-range vitamin D may have anti-inflammatory effects in humans     is uncertain. Recent clinical studies indicate that beneficial effects of vitamin D for     several important outcomes may occur over a wide range of serum 25-hydroxyvitamin D (25-OHD)     concentrations, possibly up to concentrations that would require vitamin D intakes ranging     from 2 to more than 10 ten times higher than the current RDA for vitamin D. Because dark skin     pigmentation is a potent inhibitor of vitamin D photosynthesis, Non-Hispanic Blacks have much     lower 25-OHD serum levels than Non-Hispanic Whites. These differences in vitamin D status may     partially explain the racial disparities in prevalence of chronic gingivitis and     periodontitis observed in the US.      We hypothesize that oral cholecalciferol supplementation can reduce susceptibility to     gingivitis over a wide range of serum 25-OHD concentrations in Non-Hispanic Whites and     Non-Hispanic Blacks. We propose to conduct a simple, single-center, randomized, double-blind,     placebo-controlled parallel-group dose-ranging study. We will compare placebo to doses of 500     IU, 2,500 IU and 5,000 IU vitamin D3 per day. We will compare the severity of gingival     inflammation that develops in response to a 28-day period of unlimited plaque growth     (experimental gingivitis) between dosage groups. Furthermore, we will evaluate the     association between achieved 25-OHD levels and gingival inflammation.      The results of this study will have several important implications, as dietary vitamin D     supplementation may be a simple, safe and inexpensive means by which to reduce racial/ethnic     disparities in gingivitis, as well as to reduce the overall burden of oral disease in the     population as a whole. The study will elucidate the dose-response relationship of the     anti-inflammatory effects of vitamin D, which in turn may lead to a revision of the current     recommendations regarding nutritional supplementation of vitamin D in order to optimize the     prevention of important medical conditions and diseases and reduce racial health disparities.   "
224196|NCT00779922|"     The purpose of this study is to determine the pharmacokinetic profile of Revlimid® in     patients presenting with Multiple Myeloma and impaired renal function, the safety of     Revlimid® in the enrolled patients population.      and evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM     and impaired renal function at completion of 3 cycles of treatment.   "
224197|NCT00779935|"     This is a Phase 4, multi-center, open-label, one-arm, pilot study in patients with active     ankylosing spondylitis refractory to conventional treatment. Remicade will be given at Weeks     0, 2, and 6 and then every 8 weeks up to Week 54. The number of patients showing ASAS-20     clinical response at Week 14 will be evaluated.   "
224198|NCT00779948|"     Evaluation of dynamic Plate-Screw-Systems for internal fixation after femoral neck fractures.     Open Registry for Comparison of 1-screw-systems (DHS) with multi-screw-system Targon FN.   "
224216|NCT00780195|"     We do not know why diabetic patients cannot protect themselves against low blood sugar.     Therefore, in this study, we will perform a comprehensive assessment of the body's response     to low blood sugar by measuring changes in blood hormones, blood sugar production, and nerve     signals.   "
224199|NCT00779961|"     The effect of timing of cleft palate repair on speech development, velopharyngeal     functioning, and facial growth remains unknown. The objective of this study is to determine     the effectiveness of early palatal repair versus The Hospital for Sick Children (SickKids)     routine palatal repair in isolated cleft palate patients by comparing speech development,     velopharyngeal functioning and facial growth outcomes. The null hypothesis is no difference     in speech development, velopharyngeal functioning and facial growth between early palatal     repair and SickKids routine palatal repair in isolated cleft palate patients.   "
224200|NCT00779974|"     The primary objective is to document function of the structurally intact subscapularis after     total shoulder arthroplasty by using electromyography. Structural integrity of the     subscapularis will be confirmed using ultrasound.      The secondary objective is to determine the diagnostic accuracy of the belly compression and     lift off tests in evaluating the integrity and function of the subscapularis when compared to     the ultrasound and electromyography (EMG).      This will be accomplished by enrolling and evaluating patients with a primary diagnosis of     osteoarthritis who have had a total shoulder replacement preformed by the PI from September     2003 through December 2007.   "
224201|NCT00779987|"     The purpose of this study is to compare the reduction in symptomatology of patients with     severe dry eye treated with autologous serum and conventional artificial tears.   "
224202|NCT00780000|"     The purpose of this study is to determine the anti-tumor activity (via objective response     rate) of alvespimycin in patients with breast cancer who have not previously received     trastuzumab (except as adjuvant therapy).   "
224203|NCT00780013|"     The objective of this study was to compare the single-dose oral bioavailability of metformin     hydrochloride (HCI) liquid 500 mg/5 mL of Ranbaxy with GlucophageA® 1000 mg tablets of     Bristol-Myers, USA following administration of a 1000 mg dose in healthy, adult, male and     female volunteers under fed conditions   "
224204|NCT00780026|"     The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict     glycemic control to improve survival and infection rates following liver transplantation in a     randomized, prospective trial.Primary objective: To determine if strict intraoperative blood     glucose control, when compared to standard intraoperative glycemic control, improves 1-year     recipient survival and decreases surgical complications, including infections, following     liver transplantation.   "
224205|NCT00780039|"     Doxorubicin has been used to treat ovarian cancer as part of different combination therapies,     but high cumulative doses should be avoided because of the risk of cardiotoxicity. Pegylated     Liposomal Doxorubicin (Caelyx) has been developed to reduce the risk of cardiotoxicity. The     purpose of this study is to evaluate the safety and efficacy of Caelyx in combination with     carboplatin in women with recurrent ovarian cancer.   "
224206|NCT00780052|"     The purpose of this study is to evaluate whether C-myb Antisense (AS) Oligonucleotides     (ODNs)is a possible treatment modality for advanced hematologic malignancies.   "
224207|NCT00780078|"     Patients with failed extubation stay significantly longer in an intensive care unit (ICU) and     have a higher mortality rate, than those intubated successfully. Reintubation is associated     with life-threatening complications and a poor prognosis. Functional respiratory tests are     frequently used as weaning parameters, however, they are not accurate enough to predict     extubation failure. The incidence of swallowing dysfunction is underestimated, mainly among     patients whose intubation lasts longer than 48 h.We previously observed that the assessment     of the swallowing function and oropharyngeal motricity, conducted by the physiotherapist     before extubation could be helpful for making decisions to extubate patients intubated for     over 6 days. The objective of this study is to validate a scale previously devised and used     for physiotherapist bedside evaluation of the swallowing function and oropharyngeal     motricity, among patients intubated for over 6 days, to determine whether this scale is a     good predictor of airway secretion-related extubation failure.Expected results : to validate     a scale previously devised called  physiotherapist evaluation of the swallowing function and     oropharyngeal motricity before extubation by the mean of a multicentric study. In our     hypothesis the clinical parameters studied could be predictive of extubation failure. Then,     this evaluation could help the medical decision in the choice of the good time for     extubation. The final objective is to lower the mortality related to extubation failure.   "
224212|NCT00780143|"     This is a Phase I/II study to determine the safety, tolerability and to identify the MTD and     DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with     relapsed/refractory leukemia and to determine the response rate of the combination of     Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.   "
224213|NCT00780156|"     Background      Drug-eluting stents (DES) have been extremely successful in reducing restenosis and the need     for repeat revascularization procedures in patients who undergo PCI. The potential increased     incidence of late stent thrombosis prompted cardiologists to prolong the use of dual     anti-platelet therapy after the one year duration recommended by the recent ESC guidelines.     However, while the premise that the cardiologists should put all their patients on dual     clopidogrel-aspirin regimen for life sounds the easy way, it is an unrealistic goal because     of the potential increase of bleeding complications and of the healthcare cost increase. The     recent possibility to monitor aspirin with bedside assays offers a real opportunity to     compare in good aspirin responder patients the two strategies: aspirin-clopidogrel regimen     versus mono-aspirin regimen and to respond to the key question: can the investigators switch     from dual to single antiplatelet therapy after six months in good aspirin responder patients     ? Study National, multicenter, randomised prospective open group comparison of dual     clopidogrel-ASA versus single ASA regimen after six months, in good ASA responder patients     treated with DES (name: XIENCE) implantation.      End point Primary: At 12 months: death, myocardial infarction, repeat urgent     revascularization, stroke requiring a new hospitalisation and major bleedings.      Secondary: Incidence at 24 and 36 months after drug eluting stent(name: XIENCE) implantation,     of the same composite endpoint and incidence at 12, 24 and 36 months of minor bleeding     complications Participating centres: 60 french centers      Date of study beginning: November 2008 Duration of inclusion: 9 months Duration of study: 45     months   "
224214|NCT00780169|"     The purpose of this study is to assess the safety, the maximum tolerated dose and the     recommended dose for phase II studies of a chemotherapy-combination of sorafenib, irinotecan,     and 5-fluorouracil (5-FU)/folinic acid (FA) (FOLFIRI) as first-line treatment for metastatic     colorectal cancer.   "
224217|NCT00780208|"     The purpose of this study is to evaluate the effectiveness and safety of Daytrana® in the     treatment of attention deficit hyperactivity disorder (ADHD) in adults who have abused     stimulants in the past. Daytrana® is a stimulant medication that has been approved by the     Food and Drug Administration for the treatment of ADHD in children over the age of 6 years     old.   "
224218|NCT00780221|"     The recognition of the association between circulating C-reactive protein (CRP) levels and     risk of coronary heart disease (CHD) has led to an increased emphasis on CRP genetic effects     on CRP level and CHD. However, the causality of CRP variants remains uncertain.The objective     of this study is to evaluate the association of CRP gene variants and CRP levels in CHD in     Chinese Han population. We conduct case-control study in CRP-Han study participants. The     common single-nucleotide polymorphisms (SNPs) in the CRP gene, haplotypes, and plasma CRP     levels are detected. A Mendelian randomization analysis will be used to help test the     likelihood of causal association of gene-CRP levels, CRP levels-CHD and gene-CHD. The     investigators hypothesize that CRP gene variants influence the protein level and may     participate in CHD progress.   "
224219|NCT00780234|"     This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic     subjects at risk for lung cancer (based on smoking history, lung function testing, and     atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest     computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at     the start of the trial and after 6 months on treatment. Compensation will be provided to the     subject after completing the trial.   "
224220|NCT00780247|"     Vitamin D deficiency is a common problem. The principal source of vitamin D for humans is     solar exposure, with cutaneous synthesis of vitamin D by photoconversion of     7-dehydrocholesterol in the skin to pre-vitamin D3. Latitude, altitude, season, skin     pigmentation, and age are recognized factors that influence how much vitamin D can be made by     solar exposure. However, the relative influences of each are largely unknown and we cannot     reliably answer the question of how much sun exposure an individual needs at various     latitudes and at various seasons in order to ensure normal vitamin D status.   "
224221|NCT00780260|"     The purpose of this study is to test two innovative case management approaches designed to     increase linkages and engagement with drug abuse treatment, HIV-related care, and other     health services among an underserved population of African American women at risk for HIV.   "
224222|NCT00780273|"     Change in crestal bone level implants at 5% significance level.   "
224223|NCT00785993|"     Egg-banking would considerably simplify the logistics and means by which oocytes could be     donated. These banks would make it easier to immediately provide oocytes that would be     compatible to the recipient, shortening or even eliminating the problem of long waiting     lists. Egg-banking would also allow the oocytes to be effectively quarantined, drastically     diminishing the risk of transmission of infectious diseases in a fashion analogous to semen     banks. The most essential prerequisite for a successful egg cryo-banking program is to have     an efficient oocyte cryopreservation technology. Recent studies, including our own     experience, have indicated that vitrified oocytes preserve intact their potential to     fertilize and further develop into competent embryos, giving high clinical results as well as     high survival rates. The aim of this study is to evaluate impact of the establishment of an     egg-banking in our ovum donation program. Oocyte cryopreservation is carried out by Cryotop     method. The study includes oocyte donation cycles conducted with fresh and vitrified oocytes.     Recipients are allocated randomly into each group (fresh vs. vitrified cycles). Main     outcome measures include survival, fertilization, embryo development and clinical outcome.   "
224224|NCT00786006|"     The investigators are to evaluate the efficacy and safety of FOLFOX or FOLFIRI.3 combination     chemotherapy as second-line salvage chemotherapy in patients with advanced pancreatic     carcinoma.   "
224225|NCT00786019|"     This study will evaluate the effects of impaired blood flow regulation on exercise. It will     also determine whether the effects are more important in the heart or in the skeletal muscle     tissue during exercise. In addition, this study will decide whether temporarily reversing     these problems will improve blood flow control, improve heart and muscle tissue function and     help improve exercise capacity in person with type 2 diabetes. This study will do so using     two methods: (1) by giving vitamin C intravenously (IV) and (2) a three month exercise     training program. Up to 100 subjects will be enrolled in this study.   "
224226|NCT00786032|"     The goal of this VA demonstration project is to show that the Brain-computer interface (BCI)     technology is a clinically practical and important new communication and control option that     can improve the lives of veterans with amyotrophic lateral sclerosis (ALS). The project will     test four well-supported hypotheses: (1) that people with ALS who find (or will soon find)     conventional assistive technology inadequate can and will use a BCI system for important     purposes in their daily lives without close technical oversight, 2) they will continue and     even increase this use throughout the period of the study, (3) that BCI use will improve     their lives, and 4) BCI will improve the lives of their families and caregivers.   "
224227|NCT00786045|"     The objective of this study is to evaluate, among persons who have completed the restorative     phase of stroke and have ceased rehabilitation, the relative effectiveness in improving     functional exercise capacity of two programs for continued care, a home-based general fitness     training program using stationary cycling and a disability targeted, home-based exercise     program to enhance mobility and walking competency. capacity compared with the walking     group and that consequently the cycle group will achieve a higher quality of life.      A secondary objective is to explore factors associated with compliance with the exercise     regimens. Previous research has indicated that cognitive-affective-behavioural profile is     related to exercise activity in a number of populations including sedentary adults, older     adults and patients with cardiovascular disease. As we anticipate that one of the mechanisms     by which the cycling will result in an outcome better than the more traditional type of     disability tailored exercise program is through greater compliance, this second objective is     very relevant. This study will also address the impact of regular exercise on cardio-vascular     risk factor profile.   "
224228|NCT00786058|"     The purpose of this study is to compare best supportive care plus oxaliplatin/ folinic acid/     5-FU versus best supportive alone in patients with gemcitabine refractory pancreatic cancer.   "
224229|NCT00786071|"     Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good     appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The     pathological mechanism is barely understood. Although feeding difficulties may play a part in     this, other constitutional factors as altered metabolic processes are suspected. Irregular     breathing is a common clinical feature, reflecting the immaturity of the brainstem in RTT.     The primary pathophysiology is a defective control mechanism of carbon dioxide exhalation     that leads to chronic respiratory alkalosis or acidosis. We assume that chronic respiratory     acidosis or alkalosis causes derangement of the metabolic equilibrium in RTT females with     important nutritional consequences.      The aims of this pilot study are to describe the nutritional status of the RTT girls and to     examine the consequences of a chronic respiratory acidosis or alkalosis on metabolic     processes as a possible cause of impaired nutritional status.   "
224230|NCT00786084|"     In 2006 this research group reported their initial findings of a multi-center prospective     trial comparing primary repair and primary repair buttressed with a biologic mesh made from     porcine small intestinal submucosa (SIS). We were able to accrue 108 patients from     7/2002-3/2005 and followed each patient over 6 months and performed an UGI to check the     durability of the repair and rule out a recurrence. The results suggested a significant     benefit for the use of SIS mesh in the short-term, with the primary group having a 26%     recurrence rate and the mesh group a 9% recurrence rate.      While these results are encouraging, it is important to know what is the durability and the     longer term benefits of the use of SIS mesh. For this reason we propose a follow-up of the     original study patients with the same outcome measures (symptom questionnaire, SF-36, and     UGI). This should give us a very good idea about the long-term success of laparoscopic PEH     repair with primary and SIS mesh.   "
224231|NCT00786097|"     The purpose of this study is to demonstrate the absence of irritation potential (primary     dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the     product Dermacyd PHDETINLYN Tangerine Mix.None.   "
224232|NCT00786110|"     The study is designed as a Phase II, prospective, non randomized, open-label, single arm,     multicenter trial, in which patients with locally advanced or metastatic ACC not amenable to     complete surgical resection and progressing to cytotoxic chemotherapy will receive Sorafenib     plus metronomic chemotherapy as treatment.The aim of this phase II trial is to evaluate the     clinical benefit and toxicity of the combination of Sorafenib plus metronomic chemotherapy in     patients with locally advanced or metastatic ACC who progressed after first or second line     chemotherapy.   "
224233|NCT00786123|"     Irritable bowel syndrome (IBS) is a very common chronic gastrointestinal disorder. Existing     therapies for IBS are still far from satisfactory and new therapies are being constantly     sought. Probiotics are promising candidate for the prevention and treatment of IBS. However,     its efficacy and mechanism is still unclear. The current study aims to evaluate the effects     of a combination probiotic, VSL#3, on symptoms and rectal sensitivity in patients with IBS.     The underlying mechanism will also be investigated. We will recruit forty patients with Rome     III IBS and randomized them, in a parallel group, double-blinded design, to take four VSL#3     capsules or placebos, twice daily, for six weeks. Before and after treatment, patients will     be assessed for their symptoms, rectal sensitivity, as well as saliva and fecal melatonin     levels. Bowel symptom diary and weekly satisfactory relief of bowel symptoms will also be     recorded and evaluated.   "
224263|NCT00793845|"     The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCR in     children with high-risk neuroblastoma. In the present study, a single arm trial of tandem     HDCT/ASCR will be carried out. In the present study, the investigators will investigate     whether tandem HDCT/ASCR might improve the survival of patients with high-risk neuroblastoma     with acceptable toxicity.   "
224264|NCT00793858|"     The purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide)     absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose   "
224234|NCT00786136|"     The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased     steadily in recent years. This has resulted in the increasing incidence of contrast-induced     acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes     mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs,     hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning     that in a patient with CKD it amplifies the risk of CIAKI.      The aim of this multicenter prospective, randomized, controlled study is to evaluate whether     statins treatment during the perioperative period would reduce the risk of CIAKI in a     high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing     coronary angiography or noncoronary angiography, and evaluate the influence of such potential     benefit on short-term outcome.   "
224235|NCT00786149|"     the purpose of the study is to see if varenicline in combination with motivational counseling     helps homeless cigarette smokers quit smoking.   "
224236|NCT00786162|"     The specific aim of the study is to assess the impact of an Internet-enabled, automated,     self-management program on blood pressure control of employees of a large local company.   "
224237|NCT00786175|"     Hypothesis: there is a high prevalence rate of diabetes, including asymptomatic undiagnosed     glucose intolerance, among subjects with coronary heart disease in Hong Kong.      A cross-sectional survey is planned to study the rate of undiagnosed diabetes and glucose     intolerance among the Chinese patients with coronary heart disease in Hong Kong. The survey     results will be important for us to plan the logistics to investigate and manage the     potential glucose abnormality of our heart disease patient.   "
224238|NCT00786188|"     This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled     study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe     postmenopausal vasomotor symptoms (VMS), defined as follows:        -  Moderate VMS: Sensation of heat with sweating, able to continue activity        -  Severe VMS: Sensation of heat with sweating, causing cessation of activity   "
224267|NCT00793897|"     A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and     preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs,     paclitaxel and carboplatin, in patients with advanced or metastatic solid tumors. In     addition, the study is expected to identify the recommended dose or dose range of BMS-754807     in combination with paclitaxel and carboplatin for Phase 2 studies   "
224239|NCT00786201|"     The experimental drug CNTO 888 is currently being studied in cancer patients with solid     tumors and this study is the first to use this drug for patients with idiopathic pulmonary     fibrosis (IPF). This study tests the safety and effectiveness of CNTO 888 compared to     placebo. The purpose of this research study is to determine if CNTO 888 is safe and to     determine its effects (good and bad) on patients with IPF. The study will be conducted at     approximately 28 sites globally. Patients can remain on usual, accepted treatment for IPF     while enrolled in the study. Participating in other experimental studies or taking other     experimental medications while participating in this study will not be allowed.   "
224240|NCT00786214|"     Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders     affecting humans. Existing therapies for FD are still far from satisfactory and new therapies     are constantly being sought. Acupuncture has been used for the alleviation of functional     gastrointestinal symptoms in several non-controlled studies. This study aims to investigate     the therapeutic efficacy of acupuncture in patients with FD.   "
224241|NCT00786227|"     The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap     initiative to develop a computerized system measuring patient-reported outcomes in     respondents with a wide range of chronic diseases and demographic characteristics. In the     first four years of its existence, the PROMIS network developed item banks for measuring     patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical     function, and social functioning. During the item banking process, the PROMIS network     conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses     to refine the meaning, clarity, and literacy demands of all items. The item banks were     administered to over 20,000 respondents and calibrated using models based on item response     theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were     developed and implemented. The network has designed a series of studies using clinical     populations to evaluate the item attributes, examine their utility as CATs, and validate the     item banks. More information on the PROMIS network can be found at www.nihpromis.org.   "
224242|NCT00786240|"     The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D     and formulation E(1).   "
224243|NCT00786253|"     Compare once daily vs on demand treatment in men with erectile dysfunction.      Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks +     4 weeks wash-out:      A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at     bedtime for 24 weeksC: PRN for 24 weeks   "
224244|NCT00786266|"     The purpose of this study is to determine if a modified version of the Sleep Enhancement     Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and     quality of life in shiftwork-naive new nurse graduates.   "
224245|NCT00786279|"     We propose a pilot study to determine the feasibility of a long-term clinical trial of     alcohol intake on atherosclerosis, the first step in determining whether moderate drinking     prevents cardiovascular disease and hence in understanding the full health effects of alcohol     across the population. We will randomize 40 participants aged 55 and older to a six-month     period of consumption of 1 glass per day of either pure alcohol (diluted to the strength of     wine) or water. At baseline and after 6 months, we will measure several standard and novel     cardiovascular risk markers in the blood and will perform magnetic resonance imaging to     measure atherosclerosis of the aorta.   "
224246|NCT00786292|"     Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to     improve the respiratory function in experimental acute lung injury (ALI). We aimed at     comparing the effects of noisy PSV with traditional PSV on the respiratory function of     patients suffering from ALI.   "
224247|NCT00786305|"     Pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated     pneumonia often resistant to antibiotics. In experimental models, nebulization of antibiotics     delivers high lung tissue concentrations of antibiotics in infected lungs and increases lung     bacterial killing. The aim of the study is to assess the efficiency of nebulized ceftazidime     and amikacin in the treatment of pneumonia caused by Pseudomonas aeruginosa in ventilated     patients.   "
224248|NCT00786318|"     The primary objective is to determine if ziprasidone is superior to standard therapies in the     emergency department treatment of the acutely agitated patient. The primary outcome will be     the length of time taken until the patient is ready to be evaluated by the psychiatric     service, or until a disposition is made.   "
224249|NCT00793663|"     The purpose of this study is ad 1) to measure the depth of hypnosis as assessed by BIS and     cAAI during an average general anesthesia with xenon or sevoflurane and to establish a     reliable monitoring system for measuring and documenting the actual depth of hypnosis for the     volatile anesthetics investigated. Ad 2) the question is to be answered whether 4 mg     dexamethasone i.v. is an effective prophylactic treatment against postoperative nausea and     vomiting in case of xenon or sevoflurane anesthesia. Ad 3) it serves to gain evidence about     the (non-)effectiveness and kinetics of ondansetron as antiemetic remedy after xenon or     sevoflurane anesthesia.   "
224250|NCT00793676|"     The G protein-coupled receptors (GPCRs) are a family of proteins expressed at the cell     membrane. They are composed of 380 members involved in the important functions of the     organism and are privileged therapeutic targets.Their expression is highly modulated     depending on the metabolic state of the cells, in particular in pathological situations.our     study proposes to determine whether GPCR expression modulation could be used as a biomarker,     either prognostic or diagnostic, of treatments.To do so , the investigators will determine     the expression profile of the 380 human GPCRs in human blood cell samples in two chronic     inflammatory pulmonary diseases : asthma and COPD (chronic obstructive pulmonary disease ) .     These have opposed inflammatory infiltrates : asthma is associated with eosinophil and Th2     lymphocyte infiltration whereas COPD shows neutrophils and macrophages within the airways     with a Th1 lymphocytic population. The GPCR signature (transcriptomic) will be determined on     total white blood cells as well as on isolated mono- and poly-nuclear populations obtained     from healthy subjects and patients selected at the asthma or COPD consultation. The     expression profiling analysis will reveal sub-groups of GPCRs whose expression is modified in     disease. The specificity of the variation of expression of these biomarker sub-populations     will be determined, by a study recruiting a hundred patients and controls per disease on this     restraint number of genes. The outcomes of the project will lead to establish GPCR identity     cards for these chronic inflammatory diseases, which might therefore be used as diagnostic     or prognostic biomarkers to follow the evolution of a disease or the efficacy of a given     treatment. In addition, detailed analysis of the identified GPCRs will lead to propose new     therapeutic targets for inflammatory diseases. This study has therefore the objective of     validating GPCRs as potential biomarkers for inflammatory diseases.   "
224317|NCT00794586|"     The purpose of this study is to evaluate the safety and efficacy of 2 dose combinations of     fosfomycin/tobramycin for inhalation (FTI), following a 28-day course of Aztreonam for     Inhalation (AZLI) in patients with cystic fibrosis and Pseudomonas aeruginosa lung infection.   "
224251|NCT00793689|"     In the study will be included patients that have undergone total thyroidectomy and do not     display obvious clinical or laboratory hypoparathyroidism. On the third postoperative day and     before the patient's exit from the hospital, the patient will undergo an intravenous infusion     test with 35ml/m2 dilution of 8.4%(w/v) sodium bicarbonate in two minutes. Three months after     the operation, if the study conditions are still met, the patient will undergo an additional     parathyroid hormone (PTH) measurement and sodium bicarbonate infusion test and the     parathyroid function will be evaluated again.   "
224252|NCT00793702|"     The primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of     the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary     objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when     injected twice with time intervals of 6 or 12 weeks to healthy adults.   "
224253|NCT00793715|"     Decompressive laparotomy with temporary abdominal closure, will decrease of overall mortality     and major morbidity in patients with abdominal compartment syndrome during acute pancreatitis     in comparison with percutaneous puncture with placement of abdominal catheter.   "
224254|NCT00793728|"     This study compares if there is any difference doing antrectomy while performing a sleeve     gastrectomy for treating morbid obesity. The investigators compare the differences between     leaving or not leaving the antrum in terms of food tolerance, weight lost and quality of     life.   "
224255|NCT00793741|"     The purpose of this study is to determine whether islet transplantation alters brain glucose     concentrations in patients with type 1 diabetes, recurrent hypoglycemia, and hypoglycemia     unawareness when compared to that measured prior to transplant in the same subjects.   "
224256|NCT00793754|"     Despite formal recommendations, evidence of efficacy of aspirin in individuals with diabetes     is scant and controversial. While the efficacy of aspirin versus placebo in patients with     diabetes is currently under investigation in big randomized controlled trials, the putative     additive effects of aspirin and statins in this population remain to be investigated.     Moreover there are no data examining the pathophysiologic means by which aspirin with or     without statins affects thrombosis in diabetic patients.      The aim of this trial is to evaluate the efficacy of low-dose aspirin (100 mg/daily),     statins, both or neither for the reduction of thrombin generation. These preventive     strategies will be evaluated on the top of the other strategies aimed at optimizing the care     of diabetic patients in terms of metabolic control and control of the other cardiovascular     risk factors.   "
224257|NCT00793767|"     Recently EPO receptors have been found in human muscle tissue, but what is still not known is     the physiological role of these receptors. In this study the researchers want to investigate     if there is any effect of a acute administration of EPO on insulin resistance and/or     substrate metabolism in muscle tissue.   "
224258|NCT00793780|"     The purpose of this clinical trial is to find out how effective low dose oral naltrexone is     on reducing body weight when compared to placebo in women with schizophrenia and     schizoaffective disorder.   "
224259|NCT00793793|"     This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA     in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA     combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients;     or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced     patients.      A secondary objective is to investigate antiviral activity, potential drug-drug interactions     and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for     treatment-naïve patients.   "
224260|NCT00793806|"     The common causes of mortality are late stages of chronic kidney disease, cardiovascular     disease and infections, are associated with abnormalities of the immune system, an underlying     state of chronic inflammation and oxidative stress. These processes have not been carefully     described in the chronic kidney disease population. The researcher can use Diffuse Optical     Spectroscopy to determine the immune system in individuals with chronic kidney disease and     describe the association with chronic inflammation and oxidative stress in that population.   "
224261|NCT00793819|"     Silodosin is compared to placebo to determine if it is safe and effective for the treatment     of nighttime urination (nocturia) in men with BPH   "
224262|NCT00793832|"     It is hypothesized that the patients in the EXDA group will be able to complete a structured     exercise program at a level sufficient to accumulate at least 2000 kcal per week, and that     the structured endurance activity will increase their physical fitness and total daily energy     expenditure compared to the DA group.   "
224266|NCT00793884|"     Latinos represent the largest minority group in the United States with a population of 35     million or 12.5%. National surveys indicate that the prevalence of type 2 diabetes is 1.9     times higher in Latinos than non-whites, and that approximately 24% percent of Latinos over     the age of 45 years have diabetes. In Georgia, Latinos make up approximately 6.5% of the     population. During 1990 and 2000, the prevalence of diabetes in Fulton and Dekalb counties,     two of the most populated areas in Georgia and the Atlanta metropolitan area increased by     30%. Language and cultural barriers represent the two most important obstacles in educating     and improving the care of Latino patients with diabetes. Less than 5% of physicians, 2% of     nurses, and 2.5% of dentists in the US speak Spanish.      The Emory Latino Diabetes education program has been in existence since December 2005. Our     program aims to deliver diabetes education in Spanish to the underserved Latino community in     Metro Atlanta. Program participants attend an initial 2.5hr diabetes education class in     Spanish. The class curriculum follows the American Association of Diabetes Educators (AADE)     seven self-care behaviors: healthy eating, being active, monitoring, medication use,     problem-solving and healthy coping. Participants are invited to return to a follow-up session     within 6 months. Follow-sessions are held in the late afternoon. These sessions are     discussion-based and include an activity such as salsa lessons and cooking demonstrations.      We would like to obtain IRB approval to analyze and publish that data we collect during our     educational sessions. We would like to collect retrospective data from past participants in     the program (for which we request a waiver of informed consent and HIPAA authorization), and     we would like to consent current and future participants to use their data.   "
224354|NCT00795093|"     The purpose of this study is to describe common treatment pathways, to collect health care     utilization data and to assess symptom load as well as impact of symptoms on daily life in     GERD patients who are partial-responders to PPI treatment.   "
224268|NCT00793910|"     The purpose of this study is to determine the effectiveness of an oral medication called     gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess     the frequency of use of rescue medication interventions, defined as non-steroidal     anti-inflammatory (NSAID) eye drops and oral narcotic medication.   "
224269|NCT00793923|"     The primary objective of this proposed research study is to evaluate the safety of     intravitreal ranibizumab in combination with intravitreal dexamethasone in comparison to     intravitreal ranibizumab alone in the treatment of wet ARMD. The addition of the broad     spectrum anti-inflammatory activity of dexamethasone may augment the anti-VEGF activity of     ranibizumab by amelioration of inflammation existing in the microenvironment of the choroidal     neovascularization. While the anti-VEGF agents have proven to be very efficacious in the     treatment of exudative ARMD, their narrow target and window of activity may limit their     overall durability of action.   "
224270|NCT00793936|"     There are specific guidelines for choice of Lt DLT size in correlation to patient's height     and tracheal diameter on chest X-ray/CT scan. Accordingly to these criteria the RT DLT size     is determined.      Should the criteria for determining the appropriate size be the same for Rt and Lt DLT?   "
224271|NCT00793962|"     The purpose of this study is to compare the efficacy and toxicities of hypofractionation     radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated     with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the     two groups.   "
224272|NCT00793975|"     The purpose of this study is to determine if IMC-1121B is safe for patients, and to determine     the best dose of IMC-1121B to give to patients.   "
224273|NCT00793988|"     Aim of study is to investigate whether a small, non-invasive vibrating device applied to the     forehead during local anaesthetic administration reduces the pain of the injection.   "
224274|NCT00794001|"     Part I (Pilot Phase): The purpose of this study is to examine if formalized data assessment     and systematic feedback improves treatment times (i.e. contact-to-balloon time and     door-to-balloon time) in patients with myocardial infarction with ST-segment elevation     (STEMI).      Part II (Implementation Phase): The Purpose is to prospectively investigate if survival can     be improved by stringent use of this concept of formalized data analysis and systematic     feedback of procedural and clinical data to all participating physicians and other members of     the STEMI patients treating personnel.   "
224275|NCT00794014|"     The purpose of this study is to establish the optimal strategy for side branch stenting in     coronary bifurcation lesion.   "
224276|NCT00794027|"     The proposed research will investigate the clinical outcomes associated with a modified yoga     training program in patients with heart failure (HF). HF patients (15-20) will participate in     a modified yoga program during an 8 week period, two times per week with instruction for home     practice. Baseline measures and follow-up will be taken after 8 weeks. The underlying     hypothesis to be tested is that yoga-induced improvements in nervous system and skeletal     muscle function will yield positive effects on clinical outcomes, functional ability, and     health-related quality of life in patients with HF.      The effect of combined yoga and breathing training on the natural history of HF and its     potential to decrease negative clinical outcomes and improve symptoms is unknown. The     relevance of this research is related to the important information it will provide to     clinicians caring for patients with HF and will be the basis for pilot data for future NIH     funding applications.   "
224291|NCT00794222|"     The mobiletype program is a mental health assessment and monitoring tool that runs on mobile     phones.      The program assesses the general mental health of young people in real-time and transmits     this data to a website to be reviewed by their general practitioner (GP) in consultation with     their patient. The website consists of individualised feedback reports for each participant,     and graphical displays of the monitoring data. The primary aims of the current project are to     examine: (1) whether the process of self-monitoring via the mobiletype program increases     young people's awareness of their mood and reduces depressive symptoms and (2) whether     emotional self-awareness mediates the relationship between self-monitoring and depressive     symptoms.   "
224304|NCT00794391|"     The purpose of this study is to evaluate the effects of a brief motivational intervention in     reducing risky injection practices among injecting drug users (IDUs). The investigators     hypothesis is that motivational intervention will be more effective than educational     intervention in reducing risky injection practices among IDUs.   "
224277|NCT00794040|"     Severe mood dysregulation (SMD) is a very common syndrome in children. Its symptoms include     very severe irritability, including persistent anger and frequent outbursts, as well as     distractibility, hyperactivity, and other symptoms of attention deficit hyperactivity     disorder (ADHD). Many children with SMD receive the diagnosis of bipolar disorder (BD) in the     community, although they do not have clear manic episodes (with symptoms such as extreme     happiness and decreased need for sleep). Because SMD has not been studied in depth, we do not     know which medications are most helpful to those with SMD. This study will evaluate the     effectiveness of the stimulant medication methylphenidate (MPH, more commonly known as     Ritalin ) when combined (or not combined) with the antidepressant citalopram (Celexa ) in     treating symptoms of SMD in children and adolescents. This study will provide information     about how to treat SMD in youth.      This study will include approximately 80 patients between 7 and 17 years of age with SMD. The     patient s symptoms must have started before age 12.      The study will consist of four phases carried out over 4 to 5 months. During Phase 1, the     patient will undergo blood and urine tests, and will gradually taper off his or her     medication. The duration of this phase depends on the patient s medication before starting     the study. In Phase 2, the patient remains off all medication for 1 week. In Phase 3, the     patient will be treated with MPH for 2 weeks, and then will be randomly assigned to receive     either MPH plus citalopram or MPH plus a placebo for a further 8 weeks. In Phase 4, the     researchers will evaluate the effectiveness of the medications taken, and begin an open     treatment phase using medications that they deem appropriate for that patient (this may     include MPH with citalopram and/or other medication combinations).      Most patients will be admitted to the Pediatric Behavioral Health Unit at the National     Institutes of Health Clinical Center during the medication withdrawal part of the study     (Phases 1 and 2). From Phase 3 on, a patient may participate as an inpatient, outpatient, or     in day treatment, depending on what is in his or her best interests.   "
224293|NCT00794248|"     This was a crossover study designed to see if patients with seasonal allergy symptoms     preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or     Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given),     followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients     were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.   "
224405|NCT00795769|"     RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing     stem cell transplant.      PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and     vomiting in patients undergoing stem cell transplant.   "
224278|NCT00794053|"     Detection of lymph nodes starting to be involved by cancer spreading from the thyroid gland     during operation is useful. It saves the patient from having a second operation to remove     these nodes later on when they become obvious. The problem is that there are many lymph nodes     around the gland. The theory is that only one node will get the first spill of the tumour     cells.      In this study the investigators are trying to use an inert colored material to inject into     the tumour. This should run in the same path as the tumour cells and should therefore stain     the one lymph node that will be affected first should the tumour spread.      The stained lymph node is excised and examined instantaneously for tumour affection. If it is     found to be affected by the tumour, then the operation is extended to include removal of all     its fellow lymph nodes. If it is found to be free from the tumour, then this patient does not     have tumour spread.   "
224279|NCT00794066|"     Purpose:      To assess the prevalence of peripheral arterial disease (PAD) in acute stroke patients.      Interventions:      Assessment of the ankle brachial index using the boso-ABI-system 100 (www.boso.de).      Design:      Prospective, open, cohort study.      Study size planned:      1500.      Follow-up duration:      3 months.   "
224280|NCT00794079|"     The purpose of this study is to determine whether omega-3 fatty acid supplementation     influences muscle protein synthesis rates in young and older adults.   "
224281|NCT00794092|"     Abdominal aortic aneurysm (AAA) is a progressive enlargement of the aorta, the largest blood     vessel in the body. It is at risk of bursting when it is usually fatal. Currently the risk of     the AAA bursting is estimated from its diameter. In this study, the investigators hope to     develop a new type of aneurysm scan involving Magnetic Resonance Imaging (MRI). It is hoped     that this scan will be better at determining which AAAs are at risk of bursting and therefore     require an operation to prevent this.   "
224282|NCT00794105|"     Observation of fluid behavior over a perforated eardrum.      A comparison of the behavior of the gas in normal vs. different kinds of otitis media ears.   "
224283|NCT00794118|"     The primary purpose of this observational study is to describe and define the current daily     practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients. Data will be     collected only from subjects providing informed consent.   "
224284|NCT00794131|"     The main purpose of this study is to determine whether, GL-ONC1, an Oncolytic Virus, can     safely be administered intravenously in patients with advanced solid tumors.   "
224285|NCT00794144|"     The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine     Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2     to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics     (study of the action of a drug in the body) in these children   "
224286|NCT00794157|"     This study was designed to provide pivotal confirmation of efficacy and safety data for 2     doses of indacaterol (150 and 300 µg once daily [od]) in patients with moderate to severe     chronic obstructive pulmonary disease (COPD). Data from this study will be used for the     registration of indacaterol in Japan.   "
224287|NCT00794170|"     Study participants who receive the I-SIGHT intervention will have higher rates of glaucoma     treatment compliance (e.g., medication-taking and refill compliance, return for clinical     follow-up) and more positive eye health outcomes at 12-month follow-up than participants who     receive the control group intervention.   "
224288|NCT00794183|"     The idea of this study is to compare different ways of setting up a pacemaker, using blood     tests to give us information about how well it's working. We hope to learn if we can use this     approach to figure out the best pacemaker setup (programming) for each individual patient.      The setting we propose to adjust is the timing between the impulse sent between top and     bottom chambers.   "
224289|NCT00794196|"     The purpose of this study is to evaluate the impact of pharmaceutical services among patients     starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of     the study is that pharmacist intervention can improve compliance to antidepressants and     patient wellbeing.   "
224290|NCT00794209|"     This was an open-label, two-phase, crossover, safety, pharmacokinetic (PK), and     pharmacodynamic (PD) study in normal, healthy, non-smoking, fasting male and female subjects.     The first phase (A. Device Qualification Phase) of the study compared three aerosol devices     to a reference device to identify a nebulizer that produced a favourable, clinically     relevant, PK and PD profile of AeroLEF. The PK and PD of the test and reference devices were     compared to 200 mcg of intravenous fentanyl administered over 1 minute.      The second phase (B. Device Characterization Phase) of the study was planned to characterize     and compare the safety, PK and PD of the selected aerosol device (identified in the Device     Qualification Phase) to 300mcg of intravenous fentanyl administered over 15 minutes if a     device was chosen during the Device Qualification Phase. The data from the selected aerosol     device would be pooled from subjects in both the Device Qualification and Device     Characterization Phases of the study.   "
224305|NCT00794404|"     The purpose of this study is to evaluate the interest of enthesis sonography for the     diagnosis of spondylarthritis, in patients with uncertain diagnosis consulting for clinical     symptoms suggestive of spondylarthritis   "
224292|NCT00794235|"     Investigation of the metabolic activity of sorafenib and sorafenib plus dacarbazine on     melanoma metastasis in patients with melanoma stage III or IV on the basis of PET/CT, LDH and     S-100 evaluation. As we hypothezise a direct influence on the transcriptome by these drugs     via antiproliferative or apoptotic signals, biopsies of melanoma skin metastases will be     assessed with microarrays and direct changes will be revealed. If positive effects on the     transcriptional profiles of metastases are revealed, patients with metastatic melanomas would     benefit from these drugs resulting in tumor regressions.      Therefore, a total of 12 patients with skin- or superficial lymph node metastases with a     diameter of at least 1 cm will be chosen for sorafenib therapy over 56 days per os twice     daily with each 400 mg and, additionally, on day 14 and 42, intravenous dacarbazine infusion     (volume depending on the body surface area (1000 mg/m2)). Before treatment with sorafenib,     before treatment with dacarbazine, and after treatment, S100 and LDH will be measured in     serum, PET/CT will be conducted and biopsy will be taken out of one skin metastasis on the     same day.   "
224406|NCT00795782|"     The purpose of this study is to determine whether the prophylactic ipsilateral central lymph     node dissection is equally effective in the management of papillary thyroid     microcarcinoma(PTMC) to the bilateral central lymph node dissection.   "
224294|NCT00794261|"     The purpose of this study is to evaluate the efficacy and tolerance of a single     administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose     chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred.      Eligible patients will be randomized. The estimated inclusion period is approximately 18     months. The duration of the research is 22 months. The maximum duration of participation for     each patient is 3 months.      The number of patients required in this multicentric and prospective study is 150 (13     participating centers).      This is a phase II, controlled, randomized, non comparative and open-label multicentric     study.   "
224295|NCT00794274|"     To determine whether CC-10004, a phosphodiesterase inhibitor, is useful in treating chronic     cutaneous sarcoidosis.   "
224296|NCT00794287|"     To determine which subclass of IgG in the serum of patients undergoing SIT against wasp venom     is able to neutralize the allergen, and therefore to prevent a positive CAST   "
224297|NCT00794300|"     The myocardial salvage assessed by using multimodal cardiac magnetic resonance imaging is a     rather new technique which can be used as a surrogate endpoint to reduce the sample size in     studies comparing different reperfusion strategies in myocardial infarction. As     reproducibility of myocardial salvage has not been evaluated appropriately, we aim to scan 20     patients on 2 subsequent days to evaluate reproducibility of myocardial salvage index.   "
224298|NCT00794313|"     Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and     uncontrolled movements called dyskinesias. A drug called amantadine can reduce these     movements. To date, there are no objective measures of these movements. The purpose of this     study is to measure the reduction of the movements by amantadine and/or topiramate using an     objective measure.   "
224299|NCT00794326|"     The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis     (PD) solution PDsol 12 in comparison with a conventional, already marketed solution,     Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim     to decrease hypertension and to improve the sodium/water balance.   "
224300|NCT00794339|"     RATIONALE: Diagnostic procedures, such as copper Cu 64-ATSM PET/CT scans, may help doctors     predict how patients will respond to treatment.      PURPOSE: This phase II trial is studying how well copper Cu 64-ATSM PET/CT scans work in     predicting disease progression in patients undergoing standard of care treatment with     cisplatin and radiation therapy (external beam and brachytherapy) per NCCN guidelines for     newly-diagnosed stage IB, stage II, stage III, or stage IVA cervical cancer.   "
224301|NCT00794352|"     Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple     sclerosis, may be related to problems with an individual s immune system. However, more     information is needed on the ways in which the cells of the immune system interact with the     central nervous system (CNS). This study will compare tests performed on both healthy     volunteers and individuals who have signs or symptoms of immune-related damage to their CNS.      This study will include two groups of subjects between the ages of 12 and 75. Subjects will     either have symptoms of immune-related CNS damage, or will be healthy volunteers selected for     comparison purposes.      Study participants will visit the NIH Clinical Center on an outpatient basis for an initial     evaluation visit. During the visit, patients will provide a comprehensive medical history and     undergo a neurological examination, and will provide blood samples for research purposes. The     healthy volunteers will be asked to schedule a return visit for a magnetic resonance imaging     (MRI) procedure, and may be asked to undergo other tests requested by the study researchers     on an as-needed basis. The group of patients with symptoms of immune-related CNS damage will     be asked to undergo a series of tests, including the following:        -  MRI procedures, with a minimum of three brain MRIs and one spinal cord MRI taken          approximately 4 weeks apart        -  A diagnostic lumbar puncture, performed on an outpatient basis        -  Tests of brain and vision activity        -  Additional blood and tissue samples      All study participants will return for a followup visit 1 year after the initial evaluation     visit. Patients with symptoms of immune-related CNS damage may be offered the opportunity to     participate in additional followup tests with NIH researchers.   "
224302|NCT00794365|"     The primary objective of this Post-Marketing Study is to monitor the safety of a novel     smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical     practice for 12 weeks among Filipino smokers.      The secondary objective is to further evaluate the effectiveness of Varenicline (Champix™) as     an aid in smoking cessation based on the 7-day point prevalence of smoking cessation   "
224303|NCT00794378|"     This study was conducted to compare the taste acceptability of Zyrtec syrup with     desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each     syrup, separated by 15 to 20 minutes on a single day.   "
224306|NCT00794417|"     The purpose of the study is to determine whether the combination of aflibercept, pemetrexed     and cisplatin is safe and effective.   "
224307|NCT00794430|"     Randomised, double-blind, placebo-controlled, parallel group, multicentre study of oral doses     of V3381, titrated to effect. A 2-week single-blind run-in period will be followed by a 13     week double-blind titration and maintenance phase. Doses will be titrated up in 100 mg bid     increments every one or two weeks, starting from 100 mg bid. A 2 week follow-up period will     conclude patient participation in the study.   "
224308|NCT00794443|"     This is a multi-center double-blind parallel-group study in involutional osteoporosis     patients to compare the efficacy and safety of monthly oral intermittent formulation     ONO-5920/YM529 with its daily formulation.   "
224309|NCT00794456|"     Phase III, multicentric, double blind, randomized study, controlled by Valeriana officinalis     for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L     and Salix alba L. on mild and moderate anxiety. The treatment period will last 6 weeks and be     followed by a post treatment visit.      Hamilton anxiety scale will be used to assess anxiety.   "
224310|NCT00794469|"     Drinking water is largely advocated for obesity prevention and management. Recent studies     have suggested that water has a thermogenic effect, this has not been examined in children.     In this study, we will measure the resting metabolic rate of 21 obese children before, and     during drinking cold (4 degrees centigrade)water for up to 60 minutes.   "
224569|NCT00798057|"     The purpose of this study is to collect information from medical records to see what effects     proton beam radiation has on pituitary tumors and analyze possible side effects.   "
224311|NCT00794482|"     This is a multi-centre, multi-national, open study to assess the pharmacokinetics of NRL972     in patients with hepatic cirrhosis CTP-classes A, B, and C (histologically confirmed by liver     biopsy). The pharmacokinetics of NRL972 will be referenced to a Clinical Staging Matrix     obtained during a clinical work-up of patients with hepatic cirrhosis. Patients to be studied     will have histologically established hepatic cirrhosis or confirmed hepatic cirrhosis by an     objective imaging study without confounding end-stage co-morbidity. Within 14 days of     confirming eligibility, the investigations will be conducted over 2-5 days with the test     procedures (clinical laboratory tests, ultrasound (US)-investigations, gastroscopy, NRL972-     and MEGX'-test). Up to one week after the NRL972-test, a follow-up telephone call will be     made.   "
224312|NCT00794495|"     This was a crossover study designed to see if patients with allergy symptoms preferred     Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec     treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by     7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked     questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.   "
224313|NCT00794508|"     Severe combined immune deficiency (SCID) may result from inherited deficiency of the enzyme     adenosine deaminase (ADA). Children with ADA-deficient SCID often die from infections in     infancy, unless treated with either a bone marrow transplant or with ongoing injections of     PEG-ADA (Adagen) enzyme replacement therapy. Successful BMT requires the availability of a     matched sibling donor for greatest success, and treatment using bone marrow from a less-well     matched donor may have a higher rate of complications. PEG-ADA may restore and sustain     immunity for many years, but is very expensive and requires injections 1-2 times per week on     an ongoing basis. This clinical trial is evaluating the efficacy and safety of an alternative     approach, by adding a normal copy of the human ADA gene into stem cells from the bone marrow     of patients with ADA-deficient SCID. Eligible patients with ADA-deficient SCID, lacking a     matched sibling donor, will be eligible if they meet entry criteria for adequate organ     function and absence of active infections and following the informed consent process. Bone     marrow will be collected from the back of the pelvis from the patients and processed in the     laboratory to isolate the stem cells and add the human ADA gene using a retroviral vector.     The patients will receive a moderate dosage of busulfan, a chemotherapy agent that eliminates     some of the bone marrow stem cells in the patient, to make space for the gene-corrected     stem cells to grow once they are given back by IV. Patients will be followed for two years to     assess the potentially beneficial effects of the procedure on the function of their immune     system and to assess possible side-effects. This gene transfer approach may provide a better     and safer alternative for treatment of patients with ADA-deficient SCID.   "
224314|NCT00794547|"     According to the Cancer Atlas, lung cancer remains the major cancer among the 10.9 million     new cases of cancer diagnosed annually worldwide. The mortality from lung cancer is greater     than the combined mortality for breast, colon and prostate cancer combined. Most patients     with metastatic non-small-cell lung cancer (NSCLC) are treated with platinum-based     chemotherapy regimens. The drug combination of cisplatin and docetaxel is one of the commonly     used regimens in metastatic NSCLC. Although both drugs are powerful disruptors of cell     growth, positive therapeutic response rates to this therapy remain low for NSCLC patients,     from 25% to 30%. While adding new biologics such as bevacizumab to the current treatment     standard can improve treatment response, median survival for advanced NSCLC patients     receiving this type of treatment remains low at under 12 months. Research studies have     demonstrated that Vitamin D, and it's signaling pathways are important biological targets in     cancer therapeutics. In vitro and in vivo calcitriol (1, 25 dihydroxycholecalciferol) is     antiproliferative and potentiates the antitumor effects of cytotoxic agents (e.g. taxanes,     platinum analogues). We have shown that administration of high doses of calcitriol and     cisplatin is feasible and associated with complete tumor regressions in dogs with spontaneous     cancers. Calcitriol has also shown to be synergistic with docetaxel both in preclinical as     well as in a recent phase II clinical trial in prostate cancer. Based on these results and     other supporting data from studies indicating that calcitriol functions as a potent and well     tolerated anti-tumor agent when used in combination with drugs likes cisplatin and docetaxel,     we hypothesize that introducing calcitriol into treatment regimes for NSCLC patients has the     potential to demonstrably improve treatment response for these patients. The overall goals     for conducting this phase I/II clinical study will be (1) to determine the maximum tolerated     dose (MTD) and dose limiting toxicities (DLT) of calcitriol in combination with     cisplatin/docetaxel in patients with advanced NSCLC, (2) to assess the response rates of     patients with advanced NSCLC to the combination of calcitriol with cisplatin/docetaxel, (3)     to evaluate the pharmacokinetics (PK) of administering calcitriol intravenously at the MTD,     and (4) to evaluate correlations between calcitriol PK and changes on specific coding regions     of the gene associated with calcitriol breakdown.   "
224315|NCT00794560|"     There is very little data available on compliance with self-injected low molecular weight     heparins (LMWH), but what there is, definitely shows that compliance represents a significant     problem. We therefore aim to a) record drug use problems of patients including compliance, b)     develop a SOP for first instruction by a pharmacist and for subsequent pharmaceutical care     and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control)     provided in the pharmacy to patients with a prescription for a LMWH as an outpatient     treatment.      Hypothesis:      Intensive pharmaceutical care in ambulatory patients who self-inject low molecular weight     heparins results in improved compliance, more safety and satisfaction as well as in fewer     complications.   "
224415|NCT00795899|"     The present clinical trial will investigate the safety and efficacy of a sequential     preoperative therapy with Epirubicin/Cyclophosphamide in combination with     Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2     overexpression primary breast cancer.   "
224316|NCT00794573|"     The EVITA study is a clinical trial that will test the effect of varenicline (Champix™), a     new drug used to help people quit smoking, in patients who have suffered a heart attack.     Varenicline has been recently shown to increase the number of otherwise healthy people who     quit smoking compared to placebo (sugar pill). Although varenicline has been shown to reduce     smoking in healthy populations, its effectiveness in patients recovering from a heart attack     is unknown. The EVITA trial will help answer this question.      A total of 300 patients who have recently suffered a heart attack and are active smokers will     be recruited in the study. For twelve weeks, half the patients will receive varenicline and     the other half will receive placebo pills. Patients will be followed for a period of 12     months. During this time, patients will receive telephone calls and go to clinic visits in     order to assess if they are smoking. These follow-ups will also assess any side effects and     clinical events such as another heart attack or hospitalization that patients may have had.     Smoking cessation will be checked using exhaled carbon monoxide readings and self-reports.      The EVITA trial will be the first study to examine the use of varenicline in patients who     have recently had a heart attack. These patients, if they continue to smoke, are at high risk     of having another cardiac event. If varenicline is shown to be useful in this population, it     will have a major impact on prevention of cardiac events in patients who have suffered a     heart attack.   "
224318|NCT00794599|"     This was a crossover study designed to see if patients with allergy symptoms preferred     Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec     treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by     7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked     questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.   "
224319|NCT00794612|"     The purpose of this study is to prove the safety of the gynaecological formulation in normal     conditions of use.   "
224320|NCT00794625|"     This study will determine the advantages and disadvantages of adding one of two different     types of drugs to stimulant treatment for reducing aggressive behavior in children with     attention deficit with hyperactivity disorder (ADHD).   "
224321|NCT00794638|"     The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab     to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended     dose for the Phase II clinical trial.   "
224322|NCT00794651|"     Develop and test a bedside testing kit for evaluating pain and symptoms of osteoarthritis   "
224323|NCT00794664|"     The purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for     26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated     lipid-lowering regimen and who are not on apheresis.   "
224324|NCT00794677|"     The purpose of this study is to test the effects of Zetia™ (ezetimibe) 10 milligrams (mg) on     the absorption of oxysterol into the blood following a meal containing oxysterol.   "
224325|NCT00794690|"     Black Cohosh extract is a form of phytoestrogen (estrogen of plant origin) that is effective     in controlling bothersome hot flushes, while avoiding the dangers of using hormones. Recent     case reports pointed to potential toxicity of black cohosh on the liver. The investigators     are trying to verify or refute such allegations.   "
224326|NCT00794703|"     The objective of this study is to compare the efficacy and safety between Mycamine and     Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant     blood diseases) or allogeneic hematopoietic stem cell transplant patients   "
224327|NCT00794716|"     This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of     steatohepatitis using fatty liver disease as the comparator group. In addition, the     sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared     to results from the standard laboratory tests, elastography, tests of metabolic markers and     serum fibrosis markers frequently used in the evaluation of clinically predicted NAFLD     patients. Patients will be included if they have clinical evidence of fatty liver disease and     have been referred to the clinic for a diagnostic work-up, including a liver biopsy, blood     tests and scans of the liver.   "
224328|NCT00794729|"     This is a sub-study of a drug development study conducted by Pfizer, Inc. It will evaluate     how well people who participate in research studies understand from the study consent form     what the purpose of the study is, the risks and benefits of participating, the procedures     they will undergo and their right to withdraw from the study before it ends. It will compare     the understanding and satisfaction of those who are given a standard consent form with those     who are given a simpler, concise consent form and examine how their understanding of the     information is affected by the length, complexity, format, and reading level of the document.      People 18 years of age and older who are participating in a Pfizer drug development study and     who are able to read and write English may be eligible for this sub-study.      Participants in Pfizer's drug development study who agree to participate in this sub-study     are randomized to receive either the standard consent form or the concise consent form. The     standard consent consists of a detailed, multiple page consent form. The concise form is     simpler, written at a lower reading comprehension level. Both forms contain all of the     required elements of informed consent according to federal regulations, and include     information needed to make a decision about participating in the study. Each form also     contains information regarding participation in this sub-study. The standard group signs the     standard consent form; the concise group is given the standard consent after reviewing the     concise form and is asked to review and sign it.      After reviewing the consent form for the main study, participants complete a 20-minute     questionnaire that includes questions that measure understanding of study information such as     its purpose, risks and benefits, compensation schemes, and other information. Additional     questions ask about how the participants made the decision to enroll in the study.   "
224329|NCT00794742|"     The purpose of this study is to test the resistance of pathogenic bacteria in infected     tissues of burn patients to various antimicrobials and enzyme debriders.   "
224330|NCT00794755|"     The main objective of this study is to assess the effectiveness of low dose Vitamin K1 (200     micrograms per day) at improving anticoagulation control in unstable patients on warfarin.     This study will also aim to look at effectiveness in the context of genes known to influence     warfarin metabolism, variability in the consumption of Vitamin K rich foods, and patient     knowledge about warfarin anticoagulation -- factors which have been associated with     anticoagulation control and which can influence the effectiveness of this intervention in     clinical practice.   "
224446|NCT00783263|"     A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the     addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in     participants treated with rosuvastatin alone and not at their National Cholesterol Education     Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal   "
224331|NCT00794768|"     This was a crossover study designed to see if patients with seasonal allergy symptoms     preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or     Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given),     followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients     were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.   "
224332|NCT00794781|"     The purpose of this study is to determine the maximum tolerated dose (MTD), safety,     tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of E6201     in subjects with advanced solid tumors.   "
224333|NCT00794794|"     This study was conducted to compare the taste acceptability of Zyrtec syrup with     desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each     syrup, separated by 15 to 20 minutes on a single day.   "
224334|NCT00794807|"     Previous Biogen studies have provided experience with the tolerability, immunogenicity, and     efficacy of a single and multiple 12-week courses of therapy of alefacept. At this stage,     experience in larger studies, as well as the FDA-approved labeling, is confined to treatment     courses of 12 weeks. The purpose of the present study is to offer an extended course of     therapy with alefacept.   "
224335|NCT00794820|"     Primary Objective:        -  To evaluate the efficacy (combined morphologic and flow remissions) of a combination of          fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL.      Secondary Objective:        -  To evaluate remission duration and survival.   "
224336|NCT00794846|"     This was a crossover study designed to see if patients with allergy symptoms preferred     Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec     treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by     7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked     questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.   "
224337|NCT00794859|"     The principal objective of the study is to investigate the effect of sorafenib on progression     free survival (time until the cancer begins to grow again,) in patients with malignant     mesothelioma who have had prior treatment with chemotherapy. Effectiveness of the drug will     also be explored with PET scans before and during treatment.   "
224338|NCT00794872|"     Cardiovascular morbidity and mortality are markedly increased in chronic kidney disease (CKD)     and may be explained in part by sympathetic hyperactivity. Impaired hyperoxic chemoreflex     sensitivity (CHRS) has been attributed to an increased sympathetic activity. The aim of the     present study is to examine whether chemosensor function is altered in patients with stage 3     and stage 4 CKD.   "
224339|NCT00794885|"     The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more     effective in preventing stroke among the patients with primary hypertension when compared to     enalapril maleate.   "
224340|NCT00794898|"     This is an open-label program of Remicade in the treatment of patients with active rheumatoid     arthritis (RA) despite treatment with methotrexate (MTX) to determine the onset of efficacy     of infliximab.   "
224341|NCT00794911|"     The main purpose of this study is to determine whether psychological intervention is     effective in improving quality of life, mood, and relationships among adults with hepatitis C     virus and cirrhosis awaiting liver transplantation.   "
224342|NCT00794924|"     Probiotics have been shown to reduce the rate of diarrhea and constipation. The purpose of     this study was to investigate if probiotics could improve outcome of hospitalized orthopedic     elderly patients.   "
224343|NCT00794950|"     A majority of patients with bladder cancer have disease confined to the inner lining of the     bladder. Patients with high risk features (high grade tumors, tumors invading into a deeper     superficial layer) are routinely treated with Bacillus Calmette Guerin (BCG) instilled in     their bladder after the tumor has been removed. While up to 55% of patients respond to BCG,     failure to respond may suggest a more aggressive tumor that requires more definitive therapy     with complete bladder removal. BCG is believed to work by stimulating the body's own immune     system to attack tumor cells. It may also work by blocking the machinery that tumors use to     grow blood vessels which fuel tumor growth. A newer oral drug, sunitinib has shown to help     patients with metastatic bladder cancer by blocking new blood vessel growth (VEGF     inhibition). The investigators are studying the use of BCG followed by sunitinib in patients     with high risk non-muscle invasive bladder cancer to evaluate the complete response (no     visible evidence of tumor in the bladder) at 3 months and 6 months. The investigators will     also evaluate whether there is recurrent tumor at three years.   "
224344|NCT00794963|"     Schizophrenia patients treated with clozapine have a high prevalence of obesity-related     metabolic syndrome. The condition is often poorly treated and may lead to the emergence of     coronary heart disease and type 2 diabetes. The study will investigate whether structured     treatment provided at the site of the outpatient psychiatric clinic of metabolic syndrome in     this population will decrease the severity of metabolic syndrome as compared with usual care     received by these patients in the community.   "
224345|NCT00794976|"     The objective of this study is to determine the safety and efficacy of a dexamethasone     iontophoretic transdermal patch for the treatment of pain associated with lateral     epicondylitis (tennis elbow).   "
224346|NCT00794989|"     RATIONALE: Ground flaxseed may prevent breast cancer in premenopausal women at increased risk     of developing primary breast cancer.      PURPOSE: This randomized clinical trial is studying how well flaxseed works in preventing     breast cancer in premenopausal women at risk of breast cancer.   "
224347|NCT00795002|"     This randomized phase II trial is studying two different schedules of alvocidib to compare     how well they work when given together with cytarabine and mitoxantrone in treating patients     with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as alvocidib,     cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. It is not yet known which     schedule of alvocidib is more effective when given together with cytarabine and mitoxantrone     in treating patients with acute myeloid leukemia.   "
224348|NCT00795015|"     The investigators are testing whether a written protocol or a computerized program can more     effectively control blood glucose after surgery.   "
224349|NCT00795028|"     Patients who have suffered a first hip fracture have a higher risk of falling and sustaining     another hip fracture compared with age-matched adults who did not fracture. Although exercise     is key to reversing this pattern, there have been very few trials that aimed to improve     muscle strength and balance as well as enhance bone health following hip fracture. Therefore,     we propose to conduct an RCT that delivers either 12 months of standard care or standard care     plus graduated exercise program for older women who have sustained a recent hip fracture.   "
224350|NCT00795041|"     The purpose of this study is to explore the concept of temporally splitting ovarian     stimulation and embryo transfer.   "
224351|NCT00795054|"     The purpose of this pilot study is to determine the feasibility of conducting a study of     out-of-pocket costs and the long-term financial impact of allogeneic stem cell transplant.   "
224352|NCT00795067|"     The investigators hypothesized that circulating endothelium-derived microparticle (EMP) may     be a useful surrogate marker of atherosclerosis and future episode of cerebrovascular events.     Peripheral blood is drawn at the time of carotid ultrasound examination. Circulating EMPs are     counted using flow-cytometry. The correlation among circulating EMP, ultrasound findings, and     atherosclerotic risk factors are determined by multiple stepwise regression analysis. The     prevalence of cerebrovascular events is also determined during 3-year follow-up period.   "
224353|NCT00795080|"     The purpose of this study is to decide which position of the neck affects cerebral spinal     fluid (CSF) flow between the spinal cord and the brain. CSF is a fluid that flows up and down     your spinal cord, around the brain and into the ventricles of the brain.   "
224355|NCT00795106|"     Chronic neck pain is a common condition that can negatively impact quality of life. Substance     P is one of the chemicals in the body that can transmit pain signals from overloaded neck     muscles to the brain. Topical capsaicin blocks the action of Substance P by releasing, and     subsequently depleting the body's store of Substance P in the nerves. Topical capsaicin has     been reported to be an effective therapy for a number of persistent pain conditions including     diabetic neuropathy, post-herpetic neuralgia, osteoarthritis, rheumatoid arthritis, and     post-mastectomy pain. This study will evaluate the efficacy of topical capsaicin to reduce     pain and improve health-related quality of life in adults with chronic muscular neck pain.   "
224356|NCT00795119|"     To diagnose bleeding inside the head, children need to have a CT Scan or MRI of their heads.     Not all doctors order these though, especially when there is no history of injury or when     children don't look too sick. Unfortunately, this means that some children's bleeding doesn't     get diagnosed as early as it could. This study wants to find a way to detect bleeding inside     the head without using a CT scan or MRI.   "
224357|NCT00795132|"     This is a phase II trial of reduced intensity conditioning with Bu/Flu/ATG in pediatric     patients with hematologic malignancies at high risk for transplant related mortality with     standard transplantation. Patients qualify based on organ system dysfunction, active but     stable infection, history of previous transplant or late stage disease. We plan to enroll 45     patients through the Pediatric Blood and Marrow Transplant Consortium (PBMTC) and anticipate     that the outcome of the trial will pave the way for phase II or III disease specific     protocols addressing efficacy of the approach compared to standard transplant approaches in     better risk patients.   "
224358|NCT00795145|"     The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG     readings) which could predispose patients to ventricular arrhythmias. This study is conducted     to satisfy this requirement.   "
224359|NCT00795158|"     The purpose of this study was to determine the effect of desloratadine treatment on quality     of life, daytime functioning, quality of sleep, symptoms, and disease severity in patients     who had hives for 6 weeks or longer. Patients took desloratadine for 1 month. Once a week,     patients filled out a questionnaire to tell how their hives affected their lives. This     questionnaire is called the Dermatology Life Quality Index or DLQI. They also filled out a     diary every day to tell how much itching they had, how many hives they had, and how their     hives had affected their sleep or daily activities. The patients and doctors rated the     patients' overall condition and how much relief patients got from treatment.   "
224360|NCT00795171|"     Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes     induced by docetaxel in HRPC patients   "
224361|NCT00795184|"     This study will collect data from patients routinely undergoing a endoscopic surveillance and     Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to     determine if endomicroscopy images collected using the marketed Cellvizio device may help     endoscopists more accurately diagnose, in conjunction with traditional tissue sampling     techniques, whether a suspected lesion is malignant or benign.   "
224362|NCT00795197|"     A screening study to identify and characterize the disease status of patients with Gaucher     Type 1 disease for potential inclusion in a subsequent phase 3 clinical study.   "
224363|NCT00795210|"     The purpose of this study is to examine the short-term effects of two different doses of     growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's     secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth     hormone administration will alter the body's endogenous pulsatile growth hormone secretion     and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that     growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to     insulin sensitivity.   "
224364|NCT00795223|"     Comparative efficacy of 24 and 48 hours post operative pain control in single total knee     replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or     0.5 % bupivacaine for single femoral nerve block   "
224365|NCT00795236|"     The purpose of this study is to learn more about abnormal body rhythms in blind boys and     girls that keep them from falling asleep at bed-time or cause them difficulty staying alert     during the day. The investigators hope to learn if there are any differences between the body     rhythms of girls and boys. The investigators also want to investigate whether age or puberty     have an effect on body rhythms.   "
224366|NCT00795249|"     The investigators hypothesized that circulating EMP is a useful surrogate marker of early     stage of endothelial damage. To determine the effects of chronic smoking on circulating EMP,     from healthy volunteers who have habit of chronic smoking, peripheral blood is drawn at the     time of flow-mediated dilatation (FMD) examination. Spot urine is also collected. Circulating     EMPs are counted using flow-cytometry. After 2-week smoking cessation, the measurements were     repeated.   "
224367|NCT00795262|"     We will evaluate the combination of quinapril and alpha lipoic acid in patients with diabetes     mellitus and hypertension. We will determine whether the combination of quinapril and lipoic     acid as compared to quinapril and placebo provides benefit on systemic blood pressure and     proteinuria.   "
224368|NCT00795275|"     Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of     glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to     abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the     objective of the current study. The investigators hypothesized that defects in GLP-1 may     explain the inappropriate basal EGP and diminished insulin secretion in IFG, and,     furthermore, that by increasing circulating GLP-1 levels (using a new medicine called     sitagliptin) the investigators could reverse these defects.   "
224369|NCT00795288|"     The primary objective of this project is to investigate the effect of statin therapy on     cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not     receive statins in a blinded design.   "
224421|NCT00795977|"     The purpose of this study is to confirm safety and immunological responses of Preoperative     intratumor dendritic cells injection immunotherapy using immature dendritic cells with S     pyogenes Preparation (OK-432) for patients with resectable pancreatic cancer for pancreatic     cancer patients.   "
235698|NCT00933842|"     Primary Objective:      To demonstrate the absence of photoirritation and photosensitization potential of the product     Dermacyd PHDESILSTYFL.      Secondary Objective:   "
224370|NCT00795301|"     Primary Objectives To estimate the pathological complete response rate following neoadjuvant     radiotherapy with concurrent capecitabine and oxaliplatin, with or without cetuximab based on     the KRAS mutation status in rectal cancer.      Secondary Objectives        1. To evaluate the incidence of grade 3-4 toxicities with each of the two neoadjuvant          regimens and during the 30-day post-operative period.        2. To estimate the clinical tumour response rate and sphincter preservation rate with each          of the two neoadjuvant regimens.        3. To correlate EGRF gene amplification with pathological response rate in those treated          with cetuximab.        4. To estimate the pattern of failure.        5. To establish an annotated tissue library with samples being obtained prior to therapy          and following therapy (at the time of surgery).   "
224371|NCT00795314|"     Uterine curettage is usually performed under the anesthesia of propofol-fentanyl or     para-cervical block,of which generally has significant incidence of respiratory depression     which increases the demand on intraoperative monitoring, or has unavoidable insufficient     blockade which results in intraoperative suffering of pain. Butorphanol is an analgesic with     combined effects on mu and kappa opioid receptors leading to a role as analgesia and     sedation. The investigators hypothesized that combined propofol with butorphanol during     uterine curettage would produce optimal effectiveness of these two drugs by adding sedative     and analgesic effects together. In addition, it would decrease the intraoperative consumption     of propofol without increase the incidence of side effects. Furthermore, such combination     would alleviate postoperative pain.   "
224372|NCT00795327|"     Primary:      Evaluate the degree of correction attainable with Poly-L-Lactic Acid(Sculptra) for the     correction of hill and valley acne scarring      Secondary:      Document types and incidence of device adverse events with Poly-L-Lactic Acid(Sculptra)     therapy.   "
224373|NCT00795340|"     RATIONALE: Cediranib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. It is not yet known whether cediranib is more effective than a     placebo when given together with paclitaxel and carboplatin in treating patients with     non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying how well cediranib works when given     together with paclitaxel and carboplatin in treating patients with stage IIIB or stage IV     non-small cell lung cancer.   "
224374|NCT00795353|"     The study is a prospective, multi-centre, observational study designed to assess the     long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic     plaque psoriasis.   "
224375|NCT00795366|"     Traumatic brain injury (TBI) is among the leading causes of trauma death and disability in     both civilian and military populations. The damage that occurs at the instant of trauma     cannot be modified; the secondary injuries that occur afterward are the impediments to     recovery and can be influenced by the physician. Cerebral ischemia is the most important     secondary event that determines outcome following TBI. To minimize ischemic episodes once the     patient has arrived at the hospital, most treatments are aimed at optimizing cerebral     perfusion pressure (CPP). The cornerstones of these treatments include mannitol, to reduce     intracranial pressure (ICP), and catecholamines, such as phenylephrine (PE), to increase mean     arterial pressure (MAP), but these agents have undesired side effects. Nevertheless, once     they lose potency, there are few alternatives. The main objective of this proposal to develop     a new therapeutic option for CPP management in TBI patients using arginine vasopressin (AVP).      AVP is the endogenous anti-diuretic hormone. It is FDA-approved for use in the diagnosis and     treatment of diabetes insipidus, for the prevention and treatment of post-operative abdominal     distention, and in abdominal radiography to dispel interfering gas shadows. It has been used     off-label for several other conditions. There is minimal information on its therapeutic     potential after TBI. The investigators have demonstrated that AVP during fluid resuscitation     rapidly restored hemodynamics, CPP, and improves acute survival in a clinically-relevant     model of TBI. The investigators observed similar short term benefits after chest and liver     trauma. Nevertheless, AVP has actions that could mask any short term benefit. The     investigators have already defined risks and benefits of AVP therapy, relative to PE, in four     different clinically-relevant laboratory model. The investigators now plan to evaluate this     new therapy relative to the current evidence-based guideline for CPP management in TBI     patients.      The working hypothesis is that the risk/benefit profile for AVP is equal, or superior to, PE     at equi-effective doses for the management of CPP following TBI. A corollary is that a higher     CPP can be safely tolerated with AVP vs catecholamines.      THE INVESTIGATORS AIM TO: Determine whether AVP is safe and effective to maintain CPP = 60 mm     Hg in TBI patients.   "
224384|NCT00795496|"     The investigators will contact 64 patients with atopic dermatitis (AD) who participated in a     long-term tacrolimus ointment trial in Helsinki 10 years ago, and ask them to participate in     this follow-up study. The investigators will do the same tests as 10 years ago, i.e.     bronchial hyperreactivity, skin prick tests, serum-IgE, Mantoux-test (2 TU), and     questionnaires about asthma and allergic rhinitis symptoms. The investigators also collect     data about their AD medication during the last 10 years.      The investigators hypothesis is that when the skin condition improves in patients with AD the     brochial hyperreactivity improves. The investigators also want to study whether different     treatments play a role in the development or resolution of bronchial hyperreactivity.   "
224376|NCT00795379|"     To assess the effectiveness of Interoceptive Exposure (IE) as a treatment to reduce negative     cognitions and arousal in a veteran sample during an anxiety-inducing situation (i.e., the     Trier Social Stressor Task - an analogue to the anxiety of undergoing exposure-based     treatment). After completing the initial screening, qualifying participants will complete a     pre-intervention assessment at UMC (structured clinical interview, self-report measures, and     a treatment-engagement analogue exercise). Half of the participants will be randomized into     either supportive counseling or to the treatment protocol at GVSMVAMC consisting of four     sessions of Interoceptive Exposure over a four week period targeting interoceptive stimuli.     Veterans will be assessed a second time at UMC after treatment (5 to 6 weeks after the first     assessment). Participants will include approximately 40 male OEF/OIF veterans with     combat-related PTSD recruited from the Trauma Recovery Program (TRP) and Post-deployment     Clinic at the G.V. (Sonny) Montgomery VAMC (GVSMVAMC). Following the pre-intervention     assessment, veterans will be randomized into one of two groups. Half of the veterans (n = 20)     will receive received four weeks of supportive counseling while the other half will receive     four weeks of Interoceptive Exposure (IE). The proposed study examines anxiety sensitivity     (AS) as a possible barrier to treatment engagement in exposure therapy for PTSD. AS is a     dispositional cognitive characteristic defined as the fear of sensations directly related to     autonomic arousal that arises from the belief that these sensations have harmful     consequences. Interoceptive Exposure (IE) is an intervention that: 1) helps individuals with     high AS increase their tolerance to the somatic sensations of arousal; and 2) promotes an     adaptive appraisal of fear-related sensations The current study will use a social stressor     task to assess the affect of IE on AS and avoidance among veterans who have PTSD, thereby     increasing the likelihood that a veteran will enter into, and remain in, treatment for PTSD.   "
224422|NCT00795990|"     This is a retrospective chart review to look at the timing of using indomethacin and     ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah     Hospital from 1/2007-8/2008. The purpose is to compare the outcomes of medical intervention     in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater,     with the birthdate being counted as day of life 1.   "
224377|NCT00795392|"     Perioperative psychological care is increasingly recognized as an essential part in the     surgical environment. Previous studies have developed a strategy to evaluate the     psychological influence after operations and found that postoperative psychological states     significantly associated with the outcomes of patients. However, preoperative evaluation of     patients the physicians do thus far is mainly the physical status assessment following the     scale of American Society of Anesthesiologists (ASA). Whether a full-scale evaluation of     preoperative psychological status to surgical patients could be a predictor to postoperative     outcomes or not is not still completely understood. The investigators hypothesized that the     preoperative psychological assessment would be an important predictor to outcomes.   "
224378|NCT00795405|"     Major sporting events may have adverse cardiovascular effects in subjects with coronary heart     disease. We also hypothesized that the adverse cardiovascular effects of sporting events are     a result of psychobiological processes including stress-induced hemodynamic changes,     autonomic dysfunction and parasympathetic withdrawal, and inflammatory and prothrombotic     responses, all of which may in turn promote myocardial ischemia.   "
224379|NCT00795418|"     This study will evaluate the safety and tolerability of repeated subcutaneous injections of     CAD106 in patients with mid Alzheimer's disease   "
224380|NCT00795444|"     The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with     a viral load below 50 copies/mL is the main limitation to eradication of the virus from the     body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore,     patients are obliged to continue with treatment for a period calculated to be greater than 60     years.      Despite the important advances in knowledge of the biology of this reservoir, we still have     no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the     first time with CCR5 coreceptor antagonists is exceptional, since the results could provide     important information on the nature of this reservoir.      If maintenance of the reservoir is a dynamic process, inclusion of CCR5 inhibitors is     expected to lead to a reduction in the size of this reservoir. This effect could be critical     when including IAT (viral reactivation), since, in theory, it would be necessary to act on a     smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of     the viral reservoir (approximately 1,000,000 cells).      The study has also been designed to enable us to understand the biochemical and molecular     mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step     to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.   "
224381|NCT00795457|"     This is a pilot vaccine study in adults with either WHO grade II astrocytoma,     oligoastrocytoma or oligodendroglioma. The purpose of this study is test the safety and     efficacy of an experimental tumor vaccine made from peptides and Montanide ISA-51 in     combination with the study drug Poly-ICLC.      Poly-ICLC, manufactured by Oncovir, Inc., has already been received and generally well     tolerated by subjects in earlier studies and has been shown to decrease the size of brain     tumors in some cases.      The immunological and safety data will be used to decide whether a larger study of clinical     efficacy is warranted in each of two patient cohorts.   "
224382|NCT00795470|"     Urinary tract infection (UTI) is a common infection in patients in the intensive care unit     (ICU) that increases length of stay but not mortality. It is not known whether antibiotic     treatment will alter outcomes. Our previous studies have documented wide practice variations     exist amongst doctors, including prescribing antibiotics to asymptomatic patients. Therefore,     the merits of various ways to manage the infection require further studies to minimize the     potential for over-prescribing of antibiotics, a practice that can increase the development     of resistant bacteria.      The objective of this pilot study is to determine the feasibility of conducting a larger     definitive study that will determine the effect of catheter change and/or systemic     antibiotics as compared to no interventions on outcomes and resource utilization in ICU     patients with UTI. Patients will be randomized to receive no treatment, antibiotics alone,     urine catheter change alone, and both catheter change and antibiotics. Their clinical     outcomes will be assessed.      Results from the pilot trial will provide information about whether it is feasible to conduct     the larger definitive trial. Results of the definitive study will provide guidance to     clinicians on how to manage a frequent clinical problem and optimize antibiotic usage.   "
224383|NCT00795483|"     The purpose of this project is to determine the incidence of osteoporosis in the     investigators' population of HIV-infected patients and to assess the efficacy and security of     zoledronic acid, whose efficacy in post-menopausal women with high fracture risk treatment     and in Paget's disease treatment has already been demonstrated.   "
224385|NCT00795509|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
224386|NCT00795522|"     This open-label study is being conducted to determine the effect of DL treatment for CIU on     symptom and disease severity, quality of life, daytime functioning, and quality of sleep.   "
224387|NCT00795535|"     The purpose of this study is to develop new triage tool for trauma patients based on HRV. EKG     will be prospectively measured in trauma patients in two locations: in the prehospital     setting (the field and during transport by helicopter) and in the hospital setting. In each     case HRV will be derived from the EKG signal, will be correlated with other non-invasive     signals (e.g. near infrared spectroscopy (NIR), and bispectral EEG (BIS)), along with other     routinely measured variables (blood pressure, respiratory rate, pulse oximetry, etc), will be     correlated with injury severity and day of discharge. An algorithm will be constructed using     multiple linear regression. The hypotheses are:        1. reduced HRV in the field correlates with bad outcome;        2. the specificity and efficiency of HRV as a screening tool can be improved by controlling          factors such as heart rate, age, gender, respiratory rate, and pulse oxygen saturation;        3. an easy to interpret HRV index can be derived that can be used for trauma triage or          diagnosis.   "
224388|NCT00795548|"     This open label phase-II trial evaluates hematological response of an additional treatment     with 5-Azacitidine to common DLI in patients with MDS or AML relapsing after allogeneic stem     cell transplantation.   "
235699|NCT00933855|"     The purpose of this study is to test a class for Queens Cancer Center patients. We want to     find out if patients think this program is helpful.   "
224389|NCT00795561|"     Upto 80% of all pregnant women experience some form of nausea and vomiting (NVP) during their     pregnancy. Hyperemesis gravidarum, a more severe form of NVP affects approximately 0.3- 2.0%     of pregnancies and is the commonest indication for admission to hospital in the first half of     pregnancy and second only to preterm labor as a cause of hospitalization overall. According     to the Hyperemesis Education and Research Foundation, conservative estimates indicate that HG     can cost a minimum of $200 million annually in house hospitalizations in the United States of     America. The investigators aim to conduct a randomized controlled trial to test the     hypothesis that the availability of day care services for the initial treatment of NVP     reduces the mean duration of stay in hospital by 1 day and results in significantly greater     patient satisfaction compared with standard inpatient management.   "
224390|NCT00795574|"     A study to assess the safety and efficacy of the IV drug infliximab for the treatment of     hidradenitis suppurativa   "
224391|NCT00795587|"     Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients     suffering intracranial hypertension following traumatic brain injury?   "
224392|NCT00795600|"     This trial is conducted in Europe. The aim of this clinical trial is to compare the change in     trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of     treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined     with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.   "
224393|NCT00795613|"     The purpose of this multicenter clinical trial is to assess the clinical impact of dose     intensification performed very early during treatment in a subset of poor prognosis,     advanced-stage Hodgkin Lymphoma patients, defined as PET-positive after two courses of     conventional adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD)     chemotherapy.   "
224394|NCT00795626|"     Evaluate the impact of systematic nursing orientations in the reduction of predicted     cardiovascular risk in patients with coronary artery disease during four nursing visits for a     1-year period and compare to a group of patients submitted to conventional treatment.   "
224395|NCT00795639|"     This protocol is for subjects with pulmonary arterial hypertension and is the first of 3     studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective     Assessment of Adding Sildenafil (SR-PAAS) program.   "
224396|NCT00795652|"     The purpose of the MOM: Managing Our Mood Program (part of Family Help) is to evaluate the     effectiveness of the Family Help distance intervention compared to usual or standard care     typically provided to women with mild to moderate postpartum depression symptomology. This is     a single-center trial based at the IWK Health Center. The primary outcome is change in     postpartum depression diagnosis.   "
224397|NCT00795665|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such     as carmustine, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving bevacizumab together with carmustine may     kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with carmustine     works in treating patients with relapsed or progressive high-grade glioma.   "
224398|NCT00795678|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Studying samples of tumor tissue and blood from     patients may help doctors understand how well these drugs can be carried to the brain.      PURPOSE: More definitive knowledge of the penetration of chemotherapeutic and other agents     into the brain is necessary for the future rational design of drug and drug regimens that     target brain metastases. This clinical trial is studying how well capecitabine,     cyclophosphamide, doxorubicin, gemcitabine, lapatinib, paclitaxel, trastuzumab, or     vinorelbine penetrates brain tumors.   "
224399|NCT00795691|"     The purpose of this study is to determine the effects of a low-carbohydrate diet compared to     a low-fat/high-carbohydrate diet on glucose control in patients who have Type 2 Diabetes.   "
224400|NCT00795704|"     The purpose of this study is to evaluate whether mulberry leaf extract will help control     blood sugar in patients with type 2 diabetes. We also want to look at the safety of mulberry     leaf extract in these patients.   "
224401|NCT00795717|"     The purpose of this study is to determine whether fish oil supplementation with Lovaza,     formally known as Omacor will result in a significant reduction in serum triglyceride (TG),     an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.   "
224402|NCT00795730|"     This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and     tolerability in healthy subjects and subjects with Alzheimer's Disease   "
224403|NCT00795743|"     Hypothesis to be tested: placement of a central venous catheter will induce a systemic     hypercoagulable state. To determine this, the investigators will measure thromboelastography     (TEG), PT(prothrombin time), PTT (partial thromboplastin time), Prothrombin Fragment 1.2,     Factor VIII, and VonWillebrand's Factor. In addition, duplex ultrasound will be performed to     correlate the laboratory coagulation values with functional changes (i.e. deep venous     thrombosis).   "
224404|NCT00795756|"     The aim of this clinical study in adult ALL is to compare by risk category (1) the     feasibility of two different CNS prophylaxis regimens and (2) the overall disease-free     survival in relation to the achievement of an early MRD negative status and following     consolidation with lineage-targeted methotrexate infusions and other disease-specific     therapeutic elements, with or without the application of allogeneic or autologous SCT     depending on risk class and MRD study results.      In this multicentric prospective pilot randomized phase II trial on CNS prophylaxis, all     patients receive induction/consolidation therapy incorporating lineage-targeted high-dose     methotrexate plus other drugs (with additional imatinib in Ph/BCR-ABL+ ALL), for the     achievement of an early negative MRD status. The MRD study supports a risk/MRD-oriented final     consolidation phase.   "
224407|NCT00795795|"     An increased incidence of aneuploid pregnancies has been reported in women of advanced     maternal age, with higher miscarriage rates. Cytogenetic studies in preimplantation embryos     have shown elevated aneuploidy rate, particularly in women over 38 years. For these reasons,     PGS has been applied to these patients to improve ongoing implantation rates, and most     importantly, to decrease the risk of further miscarriages and affected offspring. In the past     two years, several RCT have raised the question whether PGS is benefitial or not in AMA     patients.      In our experience, PGS outcome in these patients offers higher ongoing implantation rates     than the previously published in RCT studies, where no benefits for PGS were found. In these     papers, poor technical skills, as well as unclear patients selection could explain the     reported lack of PGS benefits.      Therefore, the objective of the present RCT is to analyze the outcome of IVF cycles with and     without PGS in two age groups:        -  Patients 38-39 years of age: 200 cyles per arm reaching embryo transfer should be          performed        -  Patients 40-44 years of age: 120 cycles per arm reaching embryo transfer Sample size has          been calculated according to our retrospective experience with higher differences in          ongoing implantation rates between cycles with and without PGS in patients of 40-44          years of age. In all patients embryo transfer will be performed on day 5. In the PGS          group one cell will be biopsy in embryos with ≥5 cells on day-3 and chromosomes 13, 15,          17, 18, 21, 22, X and Y will be analyzed in two rounds. In the third round, nuclei with          undoubtful or non-conclusive results will be analyzed using subtelomeric probes.   "
224408|NCT00795808|"     1. Metformin increases the pregnancy rate when added to the standard treatment of          anovulatory polycystic ovary syndrome (PCOS).        2. Metformin in combination with clomiphene, is more effective than clomiphene alone or          metformin alone improves fertility outcomes in women with PCOS of reasonably healthy          body weight (BMI </= 32).        3. Metformin improves fertility outcomes in women with BMI > 32 with PCOS.   "
224409|NCT00795821|"     The purpose of this study is to assess whether LY2216684 is superior to placebo in the     treatment of adult patients with major depressive disorder.   "
224410|NCT00795834|"     The purpose of this study is to assess the effects of a novel beverage rich in polyphenols     (compounds present in fruit extracts) on risk factors associated with cardiovascular disease.   "
224411|NCT00795847|"     It is difficult to control morning hypertension in practical clinical situation. Angiotensin     receptor blocker (ARB) and thiazide are suggested to be effective to maintain the     antihypertensive effects for 24 hours. However, monotherapy sometimes is not enough to     control blood pressure level in the next morning and there are little evidence of the     combination therapy for morning hypertension. The investigators hypothesized that a losartan     50 mg/hydrochlorothiazide 12.5 mg combination drug, Preminent, is effective and safe for     controling morning hypertension, compared with high-dose of losartan 100 mg, in Japanese.     Patients with morning hypertension were randomized to preminent treatment group or high-dose     losartan treatment group. The efficacy and safety were compared after 3-month treatment.   "
224412|NCT00795860|"     Clearly the effects of diet and exercise are beneficial for obese persons, but the underlying     mechanisms for the improvements in metabolic health are not completely clear. Although     mounting evidence suggests that alterations in lipid metabolism in persons with abdominal     obesity are associated with a several medical complications, including diabetes, little is     known about the factors responsible for this effect. The project in this application is     designed to examine how the addition of endurance exercise training to a weight-loss program     alters whole-body fatty acid availability, uptake, and oxidation as well as the expression of     cellular factors that regulate these processes. In addition, we will evaluate whether these     alterations are associated with improvements in insulin sensitivity. In the end, these     experiments will provide insight into the cellular and whole-body adaptations in fatty acid     metabolism in response to weight-loss and exercise training that may lead to enhancement of     insulin sensitivity. Identifying relationships between gene expression, whole-body fatty acid     metabolism and clinical outcome measurements, such as insulin sensitivity, may lead to     improvements in the therapeutic and/or the preventative approach to obesity and its     co-morbidities.   "
224413|NCT00795873|"     Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over     5 years.   "
224414|NCT00795886|"     Objectives:      Primary objective: Evaluate toxicity of rapamycin when used for post-bone marrow transplant     graft vs. host disease prophylaxis in children with acute lymphoblastic leukemia (ALL).      Investigator initiated; four participating institutions; Phase II pilot study   "
224416|NCT00795912|"     Inflammation and fibrosis may be important contributors to worsening heart failure. As well     as lowering cholesterol, statins are also known to reduce inflammatory markers such as     C-reactive protein which are elevated in severe heart failure. Therefore, this project will     evaluate the benefit, if any, of statins on markers of heart structure and function, on     inflammatory markers and markers of fibrosis in patients with normal cholesterol.   "
224417|NCT00795925|"     The open-label dose-escalating two-centre study was designed to assess the pharmacokinetics     as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years     of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of     detrusor overactivity (overactive bladder) for determination of the recommended dose in     children.   "
224418|NCT00795938|"     This study to will compare the blood levels of sildenafil following administration of an     experimental tablet vs. the conventional oral tablet.   "
224419|NCT00795951|"     An open, prospective,single-site, non-randomized study of the efficacy and safety of T.R.U.E.     TEST Panel 1.1, 2.1 and 3.1 allergens in children and adolescents   "
224420|NCT00795964|"     Lung function impairment is common after abdominal surgery. Few preventive strategies exist     against postoperative lung function impairment. A new potential preventive strategy against     postoperative lung function impairment comes from research on critically ill patients with     severe respiratory failure. In this field research has long focused on influence of breathing     volume (= tidal volume) during mechanical ventilation on outcome. It has been shown, that low     tidal volumes improve patients outcomes as compared to (conventional) high tidal volumes.     Therefore, we propose a patient and investigator blinded randomised trial to test the     hypotheses that intraoperative mechanical ventilation with low tidal volumes as compared to     high tidal volumes reduces postoperative lung function impairment in high risk patients.   "
224424|NCT00796029|"     The purposes of this study are to investigate the metabolic pathways of paliperidone and     excretion of paliperidone and its metabolites in healthy adult male volunteers, both CYP2D6     poor and extensive metabolizers, after administration of a single 1-mg oral dose of     14C-paliperidone, to evaluate the safety and tolerability of paliperidone, and to determine     the relationship between genotypes (CYP2D6, CYP3A4, CYP3A5, UGT1A1, and UGT1A6) and exposure     to paliperidone and its metabolites.   "
224425|NCT00796042|"     People with spinal cord injuries posses many factors that increase their risk of developing     pressure ulcers. Not surprisingly, approximately 82% of persons with spinal cord injury (SCI)     will experience a pressure ulcer at sometime during their life. Earlier guidelines for the     assessment and treatment of pressure ulcers produced by RNAO in 20027 recommended that a     client who has a pressure ulcer on a seating surface should avoid sitting. Unfortunately,     this recommendation has fueled the long standing view that people with pressure ulcers should     stop using their wheelchairs and return to bed. The strength of evidence assigned for this     recommendation was Level=C reflecting the paucity of research evidence to support this common     practice. Not only do the benefits of bed rest on healing remain to be demonstrated, there is     mounting evidence that bed rest can be harmful to a person's overall health and well being.     Bed rest has been shown to be strongly associated with complications in most body systems     including respiratory, cardiovascular, musculoskeletal, cerebrovascular, gastrointestinal,     and genital-urinary. Psychosocial complications and cognitive impacts are also well     documented. Without evidence to dispel the myth that bed rest is best it will be difficult     to change practice and avoid many of the secondary complications. This study is a pilot study     to 1) determine whether pressure ulcers heal faster in individuals with SCI who receive an     individualized community-based, pressure management and mobility program compared to a     similar group assigned to usual care (bed rest), 2) determine the strength of the association     between the intervention (pressure/mobility or bedrest) and wound healing, motor     performance/independence and quality of life while adjusting for motivation to regain     independence, degree of caregiver burden, and compliance with the intervention, 3) determine     whether individuals with SCI who participate in a pressure/mobility management program     experience fewer secondary complications than those who do not participate, 4) determine the     cost-effectiveness of providing a time-efficient, pressure management and mobility program     compared to bed rest.   "
224426|NCT00796055|"     To determine the safety, tolerability, and the highest dose of this drug given once every 3     weeks or once every week, (per 21 day cycle) in adult subjects with relapsed or refractory     solid tumors.   "
224427|NCT00796068|"     This phase II trial studies how well giving treosulfan together with fludarabine phosphate     and total-body irradiation (TBI) works in treating patients with hematological cancer who are     undergoing umbilical cord blood transplant (UCBT). Giving chemotherapy, such as treosulfan     and fludarabine phosphate, and TBI before a donor UCBT helps stop the growth of cancer cells     and helps stop the patient's immune system from rejecting the donor's stem cells. When the     stem cells from a related or unrelated donor, that do not exactly match the patient's blood,     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor     can also make an immune response against the body's normal cells. Giving cyclosporine and     mycophenolate mofetil after the transplant may stop this from happening.   "
224428|NCT00796081|"     The purposes of this study are to characterize the pharmacokinetics of paliperidone after     single- and multiple-dose administration of paliperidone ER in children and adolescent     patients (>= 10 to <= 17 years of age) with schizophrenia, schizoaffective disorder, or     schizophreniform disorder and to evaluate the safety and tolerability of paliperidone ER in     this patient population.   "
224429|NCT00796094|"     The purpose of this study is to evaluate the potential importance of tissue elasticity in the     assessment of soft tissues including muscles, tendons and ligaments and other soft tissue     structures.      The evaluation of tissue elasticity (easily stretched or moveable) may assist in assessment     of various soft tissue structures, such as fatty atrophy of muscles, tendon/ligamentous     injury and healing and other soft tissue structures.   "
224430|NCT00796107|"     This study will determine the safety and efficacy of R1507 in combination with letrozole in     patients with advanced breast cancer. In the first part of the study a cohort of patients     with advanced breast cancer will receive letrozole 2.5mg po daily in combination with R1507     16mg/kg every 3 weeks. A second cohort of patients who have either progressed or plateaued on     letrozole treatment will receive 3-weekly cycles of combination treatment with letrozole and     R1507. The anticipated time on study treatment is until disease progression or unacceptable     toxicity, and the target sample size is <100 individuals.   "
224431|NCT00796120|"     The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to     standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of     connective tissue cells) (TRS).   "
224432|NCT00796133|"     This is a Phase 2, dose-finding, cross-over study for the purposes of evaluating the effect     of a NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women.   "
224433|NCT00796146|"     To describe clinical, immunological, and virological characteristics of persons with acute     HIV infection        1. To describe demographics and behavioral risk factors for those identified with acute HIV          infection        2. To describe neurocognitive function and neuroimaging findings in acute HIV infection as          well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal          fluid.        3. To describe the number and characteristics of sexual contacts        4. To describe the willingness of acute HIV-infected subjects to allow the tracking of          their sexual contacts for voluntary HIV counseling and testing (VCT)        5. To describe immune response, HIV-1 genotypes and sequences in the genital compartment        6. To describe T cell depletion in the gut mucosa in acute HIV infection and describe the          changes in gut T cell during follow up        7. To archive samples for future investigations including determination of viral evolution,          and cell-mediated and humoral immune responses in peripheral blood and mucosal          compartments   "
224434|NCT00796159|"     This is a Post-Marketing Surveillance study evaluating the Efficacy, Tolerability and Safety     of Olmesartan medoxomil 20 mg in combination with 12.5 MG of hydrochlorothiazide in subjects     with mild to moderate essential hypertension   "
224435|NCT00796172|"     High blood pressure and high cholesterol are both causes of cardiovascular disease (CVD), and     it is important for people with these conditions to adhere to their medication regimens. This     study will evaluate the effectiveness of a computerized program that provides individualized     feedback to participants and their doctors for increasing medication adherence among people     at risk of developing CVD.   "
224519|NCT00797407|"     The purpose of this study is to determine of creatine will prevent or treat the muscle     toxicity side effect of statin drug therapy, whose symptoms are aching, cramping, and     weakness. This is tested in patients who have had this side effect from 3 different statin     drugs.   "
224436|NCT00796185|"     The purpose of this study is to compare the steady-state pharmacokinetics of paliperidone     after oral administration of 15 mg extended-release (ER) OROS paliperidone once daily with     the steady-state pharmacokinetics of paliperidone after oral administration of 8 mg     immediate-release (IR) risperidone twice daily; and to explore the dose-proportionality of 9     mg and 15 mg ER OROS paliperidone. Other objectives are to 1) document the disposition of the     enantiomers of paliperidone; 2) explore the relationship between genotype (CYP2D6, CYP3A4,     CYP3A5, UGT1A1, and UGT1A6) and pharmacokinetic parameters; and 3) assess safety and     tolerability.   "
224437|NCT00796198|"     Hypothesis: Studies suggest that patients with low diastolic velocity and high resistivity     index in the ophthalmic artery had more progressive visual fields, the investigators     hypothesize therefore that addition of Cosopt to Latanoprost could improve ocular diastolic     perfusion pressure (ODPP).      Objective: To evaluate the effects of Cosopt on ODPP in patients not adequately controlled     with latanoprost alone.   "
224438|NCT00783159|"     This intervention study tests training methods to stabilize or improve functionality in the     high risk group of prefrail elderly persons.   "
224439|NCT00783172|"     It is hypothesized that OGF biotherapy may be safely administered in combination with     gemcitabine to individuals with unresectable pancreatic cancer. The study includes two aims,     the first is to evaluate the safety and toxicity of the combination of OGF and gemcitabine     chemotherapy. The second aim of the trial is to study the efficacy of OGF and gemcitabine     when used in combination.   "
224440|NCT00783185|"     Intention of the study is to examine, if the symptomatology of dual diagnosis patients is     less severe after a special indication training for reduction of cannabis consumption in     comparison to unspecified trainings.      Point of interest is psychopathology and consumerism.   "
224441|NCT00783198|"     This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH     39641/MK-3641) compared with placebo in participants with ragweed-induced rhinoconjunctivitis     over a one-year period. It is expected that ragweed allergic participants on one of the     active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and     require less allergy rescue medications during ragweed pollen season.   "
224442|NCT00783211|"     This was a randomized, double-blind, parallel-group, multicenter study that used both an     active control (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily     during a 15-day treatment period. The active treatments and placebo were allocated in a 2:2:1     ratio.   "
224443|NCT00783224|"     This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of     perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo     mometasone, active fluticasone, or placebo fluticasone.   "
224444|NCT00783237|"     This was a single-dose study to determine the time it takes for mometasone furoate nasal     spray to go in effect, after a single dose of 2 sprays per nostril. Patients who are eligible     were exposed to ragweed pollen for 3 hours on one or two occasions. Patients who experienced     adequate symptoms during the pollen exposure phase came back for a Treatment Phase visit.     During the Treatment Phase visit, patients were exposed to ragweed pollen for 2 hours and     then received either mometasone or placebo nasal spray. Symptom evaluations began on the     patients every hour for the next 11 hours.   "
224445|NCT00783250|"     The aim of this study is to assess the effects on respiratory mechanics of one classical     short-term bronchodilator (i.e., salbutamol) versus placebo, and to verify the hypothesis     that the addition of another bronchodilator (i.e., anticholinergic) may induce a further     improvement on the work of breathing of stable COPD patients.   "
225277|NCT00801060|"     This is a Phase 2, randomized, open-label, multicenter study in subjects with previously     untreated CLL. It is designed to evaluate safety and efficacy of fludarabine,     cyclophosphamide, rituximab (FCR) and lumiliximab versus FCR alone.   "
224447|NCT00783276|"     The dopamine system is critical in modulation of reward and has been implicated in the     initiation and maintenance of addiction (Volkow et al 2004). Medications that increase     dopamine either directly or indirectly have been shown to have preliminary efficacy at     reducing cocaine use in cocaine dependent subjects (Grabowski et al 2004a; Schmitz et al     2008). A novel class of medications that has recently been shown to indirectly modulate     dopamine function is adenosine A2A receptor antagonists (Fuxe et al 2007). Based on their     effect on dopamine function it has been suggested that these compounds may be efficacious in     the treatment of drug addiction (Ferre et al 2007c). Before clinical efficacy studies are     undertaken, more basic research on the effects of adenosine A2A antagonists on brain function     and behavior are warranted. The aim of this study is to examine the acute effects of a single     dose of the selective adenosine A2A antagonist (SYN115, Synosia Therapeutics, Chemical name:     4-Hydroxy-4-methyl-piperidine-1-carboxylic     acid-(4-methoxy-7-morpholin-4-yl-benzothiazol-2-yl)-amide) on brain function and behavior in     cocaine dependent individuals using functional magnetic resonance imaging (fMRI). To examine     the effect of a single dose of SYN115 on brain function and behavior in cocaine dependent     subjects.      Hypotheses:        1. SYN115 100 mg will increase brain activation in the dorsolateral prefrontal cortex          compared to placebo in cocaine dependent subjects performing a working memory task.        2. SYN115 100 mg will increase brain activation in the ventral striatum compared to placebo          in cocaine dependent subjects performing a reversal learning task.        3. SYN115 100 mg will reduce brain activation in the anterior cingulate gyrus and amygdala          compared to placebo in cocaine dependent subjects performing a cocaine-word Stroop task.   "
224448|NCT00783289|"     The primary objective of this study is to evaluate the safety and tolerability of escalating     multiple SC doses of MEDI-563 in adult subjects with asthma.   "
224449|NCT00783302|"     To assess prognostic value of CCTA examination in subjects who undergo CCTA as part of their     medical care when compared to a standard of truth, i.e. subject outcomes during each     follow-up period.   "
224450|NCT00783315|"     Many people who are obese also have high blood pressure, high cholesterol, or diabetes—all     conditions that can increase the risk of heart disease. This study will evaluate two programs     that aim to encourage weight loss among obese people who are at risk for developing heart     disease.   "
224451|NCT00783328|"     To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced     malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese     studies.   "
224452|NCT00783341|"     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending     doses of GAP 134 administered as 6-day continuous IV infusions to healthy subjects.   "
224453|NCT00783354|"     This double-blind pilot study was conducted to establish the best way of using desloratadine     treatment to protect quality of life of chronic idiopathic urticaria (CIU) patients, after an     initial 4-weeks of daily treatment: prolonging systematic daily treatment or as needed (PRN;     in the case of symptoms).   "
224520|NCT00797420|"     The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole     loading dose in infants and toddlers.   "
224454|NCT00783367|"     Pre-clinical data and recently published clinical data suggest a synergistic effect between     lenalidomide and dexamethasone. We hypothesize that a combination of     lenalidomide-dexamethasone can overcome rituximab resistance. To determine the response rate     to lenalidomide and dexamethasone plus rituximab therapy in subjects with recurrent small     B-cell non-Hodgkin lymphoma who have had lymphoma progression within 6 months of being     treated with rituximab alone or with a rituximab-containing regimen, we propose initial     treatment with both drugs for two 28-day treatment cycles (Part I). After response assessment     following two cycles of lenalidomide-dexamethasone, patients will enter Part II of the study.     In Part II, patients will receive lenalidomide-dexamethasone and rituximab to evaluate the     potential reversal of rituximab resistance as measured by response to rituximab and     progression-free survival following rituximab.   "
224455|NCT00783380|"     Evaluation of the immunogenicity and reactogenicity of two different formulations of     commercially avail-able influenza vaccines in 4 different groups of immunocompromized     outpatients (HIV positive patients, patients suffering from rheumatologic diseases and     receiving treatment with immunosuppressive drugs and patients undergoing hemodialysis or     continuous ambulatory peritoneal dialysis). The aim of the study was to investigate if the     newest formulation of influenza vaccines (virosomal vaccines) offer a benefit in     immunocompromized patients in comparison to an older subunit formulation.   "
224456|NCT00783393|"     The primary purpose of the study is to evaluate the efficacy (overall response) and safety of     temozolomide in Step 1 at the dose and regimen approved in the US and the EU countries (28     day cycles of temozolomide at 150 to 200 mg/m2 once daily for 5 consecutive days with a 23     day rest period) in patients with anaplastic astrocytoma at first relapse.   "
224457|NCT00783406|"     This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355     in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are     intended to explore the anticipated clinical dose range.   "
224458|NCT00783419|"     A retrospective review of women who came through the ER at SMH with a pelvic inflammatory     disease (PID) or tubo-ovarian abscess (TOA) between 1995-2005. They were looking at people     with this diagnosis to determine how they were treated, whether as inpatient or outpatient     and whether they were treated with drugs and how were these given and also did they develop     an abscess.   "
224459|NCT00783432|"     The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine     hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)   "
224460|NCT00783445|"     Black Americans with a family history of early heart disease tend to have a group of risk     factors that can contribute to heart disease. These risk factors, which include excess body     weight, high blood pressure, and high cholesterol, are known collectively as metabolic     syndrome. This study will compare a community-based, coach-led exercise program to an     individual, self-led home-based exercise program to determine which program is more effective     at reducing the metabolic syndrome risk factors that can lead to heart disease.   "
224461|NCT00783458|"     This was a one-day single dose trial conducted to compare patient's preference for Nasonex®     (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2     sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take     one dose of the opposite medication. Questionnaires were given to each patient after each     drug dose to evaluate patient product preference.   "
224462|NCT00783471|"     To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for     treating patients with the diagnosis of advanced Non-Small-Lung-Cancer   "
224463|NCT00783484|"     First in human study to evaluate the safety, tolerability, and pharmacokinetics of     PF-03716539. The potential of PF-03716539 to increase the concentrations of midazolam,     darunavir and maraviroc will also be evaluated.   "
224562|NCT00797966|"     Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an     assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an     incomplete response to a prospective eight week trial of the same assigned open-label     marketed ADT.   "
224464|NCT00796211|"     This will be a phase 2a single-center, randomized, blinded, vehicle-controlled exploratory     study to assess the activity and safety of CRx-197 in subjects with plaque psoriasis.     Approximately 20 male or female subjects with chronic plaque type psoriasis, 18 to 70 years     of age, will be included in this study.      All subjects with stable psoriatic plaques will receive all of the following treatments each     in a separate test field, once each day for four weeks under occlusion:        -  CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)        -  CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)        -  0.1% nortriptyline HCl topical cream        -  0.005% calcipotriol topical cream        -  Vehicle of CRx-197 topical cream (placebo)   "
224465|NCT00796224|"     The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical     response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER     (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.   "
224466|NCT00796237|"     The overall aim of the proposed study is to determine whether whole body vibration is     beneficial in promoting bone turnover, physical fitness and neuromotor performance in     patients with subacute stroke.   "
224467|NCT00796250|"     This is a double-blind, double-dummy, prednisolone-controlled, multi-center, randomized,     parallel-group clinical study to evaluate the therapeutic efficacy of repeated infliximab     infusions in order to maintain Crohn's disease remission at the end of the study.   "
224468|NCT00796263|"     This is a protocol designed to randomize subjects with acute HIV infection to receive     standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol     title: Establish and characterize an acute HIV infection cohort in a Thai high risk     population.      To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV     infection period on immunological and virological outcomes.   "
224521|NCT00797433|"     This is a study to determine the testosterone serum levels in male patient with acute     respiratory failure requiring mechanical ventilation. The objective is to determine if low     levels exist in this population and if it correlates with length of mechanical ventilation.      Hypothesis: Serum testosterone levels in mechanically ventilated male patients are     significantly decreased from normal levels and correlate with disease severity and outcomes.   "
224469|NCT00796276|"     The purpose of this study is to characterize the pharmacokinetics of paliperidone in plasma     and urine after intravenous (i.v.) administration of the racemate, administration of the     immediate-release (IR) racemate oral solution, administration of the ER OROS tablet, and     administration of the oral solutions of the individual enantiomers R078543 (+) and R078544     (-); to determine the absolute oral bioavailability of IR and ER OROS paliperidone; to     document the (+) and (-) paliperidone enantiomer ratio after i.v. and oral administration (IR     and ER OROS paliperidone); to document the possible interconversion between the (+) and (-)     enantiomers of paliperidone after oral treatment with the separate enantiomers; to document     the possible relationship between the subject's CYP2D6 phenotype and the (+) and (-)     enantiomer disposition of paliperidone (CYP2D6 genotyping was used to corroborate the     phenotype). In addition, the safety and tolerability of all treatments will be evaluated.   "
224470|NCT00796289|"     The primary objective of this study is to determine the safety and efficacy of pulsatile GnRH     delivered from a iontophoretic patch (Lutrepatch) for induction of ovulation in women with     anovulatory/ oligoovulatory infertility, compared to placebo and to a reference treatment     with clomiphene citrate.   "
224471|NCT00796302|"     This study will determine the safety and effectiveness of two medications for treating     aggression in children with attention deficit hyperactivity disorder (ADHD).   "
224472|NCT00796315|"     The primary goal of this study is to characterize the pharmacokinetics of doxylamine     succinate in children ages 2 to < 18 years. Once characterized, these pediatric     pharmacokinetic data will be pooled with historical adult PK data from other studies to     assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug     exposure as that associated with efficacy in adults.   "
224473|NCT00796328|"     This study is designed to determine the ED90 for an infusion of phenylephrine to prevent     spinal induced low blood pressure in parturients presenting for an elective cesarean     delivery. The up-down methodology (UDM) is commonly used study method to determine the dose     of a drug that causes the desired effect in over 90% of the subjects to whom it given. For     example: the investigators want to know what is the best dose of phenylephrine (from a range     of commonly used doses) to prevent a drop in blood pressure during cesarean delivery ninety     times out of one hundred when it is given at that dose. The ED90 is the effective dose at     which 90% of subjects will have a positive response to a phenylephrine infusion, i.e. no     drop in blood pressure. The investigators hypothesize that the ED90 will be between 40 - 60     mcg/min.      The primary outcome measure is the ED90 for phenylephrine infusions that prevents a drop in     blood pressure in women undergoing cesarean delivery.   "
224474|NCT00796341|"     Implantation of the human embryo is the limiting factor in the success of     invitro-fertilization and embryo transfer(IVF-ET).We wanted to find out whether creating a     local injury to the endometrium in the non-transfer cycle would improve the IVF-ET outcome in     the subsequent cycle.We believe that the injury created causes release of substances which     help in implantation.   "
224475|NCT00796354|"     Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.   "
224476|NCT00796367|"     The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521     compared to placebo for the treatment of overweight and obesity in adults who have completed     study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol     OB-303 (NCT00553787).   "
224477|NCT00796380|"     The purpose of this study is to evaluate the efficacy of Xingnaojing for the treatment of     convulsive diseases; to investigate whether convulsion episodes can be induced or aggravated     by Xingnaojing and the role inflammation plays in the process.   "
224478|NCT00796393|"     We put forward that probiotics have an effect on infectious episodes evolution in subjects     aged 60 years or over. The main objective of this research is to observe the effect of     consumption of the probiotic on the average number of days with infectious episodes.   "
224563|NCT00797979|"     Bone flaps after craniotomy are typically fixed with suture material, mini plates and others     devices. In some cases, fixation with suture material is not secure as it may result in     shifting of the bone flap with its dislocation. We will test the safety and efficacy of SKULL     GRIP a new device for fixation of the bone flap during cranial procedure comparing to     traditional suture materials.   "
224564|NCT00797992|"     To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary     to pathologic myopia (PM-CNV).   "
224479|NCT00796419|"     Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are similar conditions     in which the lungs are critically injured by another inflammatory process in the body.     Together they affect more than 150,000 people per year in the United States, with mortality     approaching 50% and a financial burden estimated to exceed $5 billion. Fluid overload, weight     gain, and reduced oncotic pressure (low blood proteins) are associated with prolonged need     for mechanical ventilation and mortality in patients with ALI/ARDS. Historical studies have     provided conflicting evidence for benefits with colloid or diuretic therapy in ALI/ARDS, but     recent clinical trials have demonstrated significant improvements in blood oxygen levels. The     mechanisms of these benefits are not yet certain, but appear to relate to albumin's (a     protein medicine) specific ability to influence injury and inflammation in the lungs, thus     improving the ability for the lung to repair and exchange oxygen.      The purpose of this project is to determine the effects of therapies that affect blood     proteins on their ability to change the way the lungs and cardiovascular system (heart and     blood vessels) function. Special measurements will be taken to understand how these protein     medicines change the ability of the lung and whole body to recover from widespread injury,     with additional measures of specific heart and lung function. This clinical trial randomizes     ALI/ARDS patients with low blood protein levels to receive albumin (a natural blood protein     that is known to influence inflammation) or hetastarch (a synthetic blood protein) with     diuretic therapy targeted to improve respiratory function. Therapeutic effects on respiratory     function and blood oxygen levels, extravascular lung water, oncotic pressure, lung fluid     removal, and heart function will be characterized. This trial will advance our understanding     of treatment of ALI/ARDS and the factors that affect fluid balance in the lungs of these     patients.      Funding Source - FDA Office of Orphan Products Development (OOPD)   "
224480|NCT00796432|"     The purposes of this study are to estimate the relationship of D2-receptor occupancy to     plasma concentration and to assess the safety of OROS paliperidone.   "
224481|NCT00796445|"     The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic     product GSK 2132231A in preventing disease relapse when given to melanoma patients, after     surgical removal of their tumor.      This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010.     The impacted sections are outcome measures and entry criteria.   "
224522|NCT00797446|"     The purpose of this study is to collect information from the questionnaire and medical     records to see what effects proton radiation has on cancer and collect and analyze morbidity     outcomes: incidence of xerostomia (dry mouth) and tumor control.   "
224482|NCT00796458|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy     may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. It is not yet known whether giving androgen ablation     therapy together with docetaxel is more effective than giving androgen ablation therapy alone     in treating patients with advanced prostate cancer.      PURPOSE: This randomized phase III trial is studying androgen ablation and docetaxel to see     how well they work compared with androgen ablation alone in treating patients with advanced     prostate cancer.   "
224483|NCT00796471|"     The purpose of this study is to evaluate the pharmacokinetics of 2 extended-release (ER)     formulations of 2 mg-eq paliperidone in comparison to the 2 mg immediate-release (IR)     paliperidone oral solution and to evaluate the effect of food on the pharmacokinetics of     these ER formulations. Additional objectives are to compare the pharmacodynamic effects     (postural changes in blood pressure and heart rate), safety, and tolerability are to be     evaluated in addition to exploring the relationship between CYP2D6 and CYP3A4/5genotype and     paliperidone exposure.   "
224484|NCT00796484|"     The purpose of this study is to evaluate the safety and tolerability of XL888 in subjects     with solid tumors. XL888 is a potent and selective inhibitor of HSP90, a key component of a     molecular chaperone complex that promotes the conformational maturation and stabilization of     diverse client proteins. Many HSP90 client proteins play critical roles in signaling pathways     implicated in tumor cell growth, proliferation, and survival.   "
224485|NCT00796497|"     Given that 5-HT3 receptors are indirect inhibitors of cortico-mesolimbic DA release, the     5-HT3 receptor antagonist ondansetron augmentation might potentially have efficacy in the     treatment of resistant Obsessive Comulsive Disorder (OCD) patients on combined SRIs and     antipsychotics.   "
224486|NCT00796510|"     As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and     does not significantly impact sildenafil pharmacokinetics the combination of most promise for     pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in     combination.   "
224487|NCT00796523|"     This is a study looking at the Happiest Baby on the Block technique. The investigators     hypothesized that infants of mothers given a 30 minute videotape demonstrating the Happiest     Baby on the Block technique would fuss/cry less and sleep longer than infants of mothers     given a 30 minute videotape on general newborn care. The investigators also hypothesized that     mothers given the Happiest Baby on the Block videotape would have lower levels of stress.   "
224488|NCT00796536|"     Chronic pain is a condition in which pain continues for 1 month or more beyond the usual     recovery period for an injury or illness or persists for months or years due to a chronic     condition. A commonly used type of psychotherapy called cognitive behavioral therapy (CBT)     has been found to be effective in treating people with chronic pain. The purpose of this     study is to determine whether and how CBT geared specifically for treating chronic pain can     change the way the brain responds to painful emotional and physical stimuli.   "
224489|NCT00796549|"     The primary objective of this open-label, single arm Phase II trial is to explore the     efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the     RECIST criteria in patients with EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected     according to the following scheme:        -  Forty (40) 1st line patients        -  Thirty (30) 2nd line patients Patients entered into the trial will be treated and          followed until death or lost to follow-up. Additional information will be obtained on          the safety profile and PK analysis of BIBW 2992.   "
224490|NCT00796991|"     The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab     when combined with Paclitaxel/Carboplatin or Dacarbazine   "
224516|NCT00797368|"     A recent study has demonstrated that a physical therapist directed exercise program did not     result in greater reductions in disability and pain when compared to a home exercise program.     However, no manual therapy procedures were incorporated into the physical therapy treatment     program despite recent evidence suggesting that thrust and non-thrust manual therapy     techniques may be beneficial in reducing disability, pain and improving gait. Therefore, the     purpose of this study is to compare the effectiveness of a physical therapy management     approach consisting of manual therapy and exercise to a home program of exercise only. The     investigators hypothesize that the group receiving manual therapy and exercise will have     better outcomes.   "
225278|NCT00801073|"     The purpose of this study is to evaluate the use of preserved scleral, corneal and amniotic     membrane graft for the surgical repair of scleral thinning of different sizes in patients     underwent surgery of pterygium with associated beta therapy .   "
224491|NCT00797004|"     The purpose of this research is to improve understanding of the molecular and functional     properties of the human olfactory system.      The specific aims are:        -  to determine the location of AC3 and Golf proteins in the human olfactory epithelium          from freshly harvested nasal/sinus tissue of surgical patients        -  to perform objective functional studies on fresh human nasal/sinus tissue using an          electro-olfactogram (EOG) whic measures the electrical activity of olfactory sensory          neurons in fresh biopsied tissue in response to odor or pheromone stimulation. An          organotypic culture system for human tissue has been established to optimize the          electrical signal acquisition.        -  to correlate the AC3 and Golf expression profiles with pre-operative testing of human          olfactory function        -  to correlate the EOG findings with pre-operative testing of human olfactory function.        -  to systematically evaluate the role of individual intranasal agents on olfaction to          further optimize the electrical signal acquisition from olfactory tissue.   "
224492|NCT00797017|"     The purpose of this observational study is to investigate the impact of fentanyl matrix on     improvement of pain and functioning in spinal disorder-related chronic pain.   "
224523|NCT00797459|"     Safety & tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L)     while correcting wrinkles in the area around your nose.   "
224540|NCT00797680|"     In this study, children who survive cardiac arrest will be evaluated whether 24 or 72 hours     of whole body hypothermia (cooling) during recovery is better to help prevent brain injury     and improve outcome. The investigators will also test the safety of cooling patients for 24     and 72 hours. The investigators hypothesize that 72 hours of cooling will be more beneficial     than 24 hours without compromising safety.   "
224493|NCT00797030|"     This study evaluates the use of topical cyclosporine 0.05% and sodium carboxymethylcellulose     0.5% for the treatment of dry eye disease in patients infected with the human     immunodeficiency virus.      Twenty HIV-positive-patients were selected from the Department of Infectious Diseases of the     Federal University of Rio de Janeiro Hospital. Dry eye diagnosis was based on a dry eye     questionnaire (Ocular Surface Disease Index - OSDI®), Schirmer I Test, break up time and 1%     rose bengal staining of the ocular surface. The patients were divided into two groups with     ten patients. Group I received sodium carboxymethylcellulose 0.5% drops and group II received     sodium carboxymethylcellulose 0,5% drops and topical cyclosporine 0.05% for six months.   "
224494|NCT00797043|"     The purpose of this study is to collect information from the questionnaire and your medical     records to see what effects the proton radiation has on you and your cancer and collect and     analyze morbidity outcomes: Incidence of xerostomia (dry mouth) and tumor control.   "
224495|NCT00797056|"     This study is designed to test the use of G-CSF in peripheral vascular disease. The     investigators hypothesize that mobilization of angiogenic cells into the blood by granulocyte     colony stimulating factor (G-CSF) may stimulate the formation of new blood vessels and result     in a sustained improvement in blood flow in patients with severe peripheral arterial disease.   "
224496|NCT00797069|"     Compare the glycemic and insulinemic responses of a standard nutritional product with two     diabetes-specific nutritional products in patients with type 2 diabetes.   "
224497|NCT00797082|"     The aim of the study is to assess the efficacy of cardiac MRI to detect coronary disease in     diabetic patients. Cardiac MRI will be compared to myocardial scintigraphy with is the method     being used in current practice. The investigators believe that cardiac MRI will be as     efficient if not better that myocardial scintigraphy to detect tight coronary artery stenosis     with the advantage of providing no radiation to the patient. Moreover, the investigators     believe that cardiac MR will add additional information regarding possible undetected     myocardial infarction.   "
224498|NCT00797095|"     The Health Behaviors in School-age Children (HBSC) study is a consortium of investigators     from 40 predominantly European and North American countries who conduct a common survey of     early adolescent health behaviors every 4 years. The survey gathers information about     nutrition, dieting practices, physical activity, injuries, violence, relationships with     family and friends, perceptions of school as a supportive environment, alcohol and tobacco     use and drug use among adolescents, and about the communities in which students live. The     U.S. sponsors of the survey are the National Institutes of Health and the Health Resources     and Services Administration. This is the fourth survey done in the United States.      The objectives of the international HBSC study are:        -  To assess the prevalence of early adolescent health behaviors        -  To identify psychosocial factors associated with adolescent behaviors        -  To provide an opportunity for analyses of cross-national comparisons        -  To provide an opportunity for analyses of trends in the U.S. and cross-nationally      In addition to the above, the survey includes additional questions designed to provide     information about areas of specific national interest, including the following:        -  To assess the association of school, family, peers, and other environmental factors on          health behavior and health status        -  To assess the prevalence and identify factors associated with obesity, diet and physical          activity        -  To assess the prevalence and identify factors associated with bullying and risk          behaviors.      This is the fourth U.S. administration of the HBSC survey, previously administered in     1997-1998, 2001-2002, and 2005-2006.      About 16,000 students in grades 5 thorough 10 at randomly selected public and private schools     across the United States complete a 30- 40-minute survey. The questionnaires are anonymous;     students are instructed not to put their name on the survey. When they finish the survey,     they place it in an envelope and seal it. The envelopes are then put in a box. Reports do not     include the names of participating counties, cities, school districts, schools, or students.      The information collected from U.S. school children is compared with similar information     collected from school children in 40 other countries. The survey is used to help set national     priorities for school and youth programs, as well as to monitor the progress of these     programs.   "
224499|NCT00797108|"     The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270     are safe and effective in patients that are hospitalized with community acquired pneumonia.   "
224500|NCT00797121|"     This study is to investigate whether preoperative biliary drainage can reduce the     postoperative morbidity in patients with hilar cholangiocarcinoma.   "
224501|NCT00797134|"     The main objective of this study is to characterize and correlate diabetic macular edema     (DME), i.e. increased retinal thickness, measured by Optical Coherence Tomograph (OCT), and     retinal visual function.      The secondary objectives of this study are the analysis and characterization of DME     progression over time (between two visits), and the comparison of OCT data obtained with     different devices.      The results of this study will be used exclusively for scientific purposes.   "
224502|NCT00797160|"     The aim of the study is to compare the intubation conditions among propofol and remifentanil     versus midazolam and remifentanil in premature neonates with respiratory distress syndrome.     At the same time, to show the group of drugs that could let the neonates with no residual     sedation after the use of surfactant (the possibility of the premature neonates to be readily     extubated after the use of surfactant).   "
224547|NCT00797771|"     Approximately 250,000 people worldwide are currently being treated with an insulin pump. This     number is growing dramatically as these devices become smaller and more user-friendly.     Insulin pumps allow for tight metabolic control and lifestyle flexibility while minimizing     the number of hypoglycemic events.      The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro-     infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by     the pressure of insulin within it to deliver preset basal profiles and patient programmed     bolus of insulin through custom infusion sets, into subcutaneous tissue.      This type of device requires extensive user interaction and education in order to ensure its     safety. This study was designed to test the independent home-use of the NiliMedix ADI Insulin     Pump, and to evaluate user's satisfaction.   "
224517|NCT00797381|"     This is an randomized, double-blind, placebo-controlled study to assess the safety,     tolerability and efficacy of MK-0518 compared to placebo when combined with other     antiretroviral drugs, in treatment-experienced HIV-infected patients with hemophilia.      Subjects enrolled in the study sign the consent form, then are randomly assigned to MK-0518     400 mg twice daily plus optimized background therapy (OBT) group or placebo plus OBT     group.Each group concludes at least 50 subjects. For each patient, detection of HIV viral     load and CD4+ T lymphocyte count is done at screening, and at weeks 4, 8, 12 and 24. The     safety profile of MK-0518 is monitored according to patients' complaints and the results of     physical and laboratory examinations.      The safety and efficacy of MK-0518 400 mg b.i.d. compared to placebo, both in combination     with OBT, will be assessed by review of the accumulated study data in HIV-infected patients     with hemophilia.   "
224518|NCT00797394|"     The purpose of this study is to determine if the combination of 2007RD01, a natural extract,     and saw palmetto lipidic extract, is more effective at treating lower urinary tract symptoms     associated with benign prostatic hyperplasia than saw palmetto lipidic extract alone.   "
224503|NCT00797186|"     This protocol focuses on the development of a noninvasive method of early coronary artery     disease detection in diabetes. The overall hypothesis is that risk factors for the metabolic     syndrome will predict invasive findings on intravascular ultrasound (IVUS) and noninvasive     findings on cardiac magnetic resonance (CMR) perfusion imaging. Secondary objectives will     include demonstrating the relative importance of individual risk factors early in disease,     demonstrating the positive effects of aggressive risk factor modification on disease,     demonstrating the relative importance of treatment of individual risk factors on disease     progression or stabilization, and that invasive findings on IVUS will predict noninvasive     findings with CMR. Such techniques may allow earlier noninvasive detection of disease as well     as tailor treatment early in the disease process making prevention more cost effective.      The specific aims of this proposal are as follows:        1. To assess whether risk factors for coronary artery disease, both known and novel,          predict quantitative and qualitative plaque characteristics on IVUS and alterations in          myocardial blood flow on CMR.        2. To assess whether improvements in risk factors through aggressive treatment improve          microvascular function as measured by CMR and plaque stabilization and/or regression as          measured by IVUS.        3. To assess which risk factors are most predictive early in disease and to demonstrate          which risk factors, when treated, provide the most benefit.        4. To assess whether findings on CMR predict findings on IVUS, thus, providing a          noninvasive method of early disease detection.   "
224504|NCT00797199|"     Hormone Replacement Therapy (HRT) is a double edged sword: it can alleviate the effects of     menopause for a significant proportion of the female population, however for a smaller     proportion, it will induce a significant increase in their short-term and lifetime risk to     develop breast cancer (BC). Fewer women are prescribed HRT compared to a decade ago due to     concerns pertaining to BC by both physicians and patients. By developing a technology that     could identify women at risk for the adverse effects of HRT, during the first few months of     its use, physicians may offer HRT to a wider proportion of the female population during     menopause. More importantly, as it relates to BC prevention, such a technology will identify     women at risk and provide a useful decision making tool regarding their care during the     menopausal years.   "
224505|NCT00797212|"     The purpose of the study was to evaluate the performance of the blood glucose monitoring     system when used with samples taken from the palm and forearm for alternative site testing     (AST).   "
224506|NCT00797225|"     This study is designed to evaluate the safety and beneficial effects of NBI-56418 compared to     placebo and leuprorelin (an approved endometriosis therapy) over a three month period     followed by an additional three months of treatment on NBI-56418.   "
224507|NCT00797238|"     The studied materials contains surgically specimens of two groups of patiens with non-small     cell lung cancer who have received two regimens of induction (neoadjuvant) chemotherapy     before tumor resection. Pathological specimens of pre-chemotherapy and post-chemotherapy     whatever retrievable will be collected. The protein ad RNA expression of DNA repair genes     (ERCC1, ERCC2, XRCC1, XRCC3, BRCA1 and RRM1) as well as DNA polymorphisms of these genes will     be studied, and will be correlate with the treatment response and outcome of the patients.     The aims of this study include:        1. To identify the expression status of the above DNA repair genes in Taiwanese NSCLC          patients.        2. To correlate the expression, as well as DNA polymorphism of each DNA repair gene in          treatment response to two differenct chemotherapeutic regimens.        3. To correlate the expression, as well as DNA polymorphism of each DNA repair gene in the          outcome of stage III NSCLC patients.        4. To explore whether platinum based chemotherapy will change the expression status of DNA          repair gene and if indeed changed, whether this would influence the outcome of the          patients   "
224508|NCT00797251|"     The use of intraoperative ultrasound (IOUS) allows us to perform new conservative     hepatectomies. The investigators previously reported the systematic subsegmentectomy by     IOUS-guided finger compression for segments 2-3, which is currently applied for patients with     hepatocellular carcinoma (HCC)on cirrhosis. The investigators herein describe a novel     technique, which consists in the systematic right posterior sectionectomy by IOUS-guided     finger compression.   "
224509|NCT00797264|"     Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid Induced     Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that ketamine     administrated separately via a continuous infusion, could induced a better analgesic effect.      We will perform a randomised double blind study to determine the best infusion mode of     intravenous ketamine, associated with morphine in PCA syringe or alone in continuous     infusion.   "
224510|NCT00797277|"     The aim of this study was to compare the efficacy and safety of intramuscular 10 mg     olanzapine versus intramuscular 5 mg haloperidol plus lorazepam 2 mg in the treatment of     acute agitated schizophrenic patients of Taiwanese populations.   "
224511|NCT00797290|"     The purpose of this study is to collect outcomes information to see what effects     photon/proton beam radiation has on nasopharynx cancer.   "
224512|NCT00797303|"     Eight patients with corneal neovascularization were treated with subconjunctival injection of     1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent     corneal neovascularization for at least 6 months unresponsive to other treatments. Patients     were monitored by ophthalmic exam and anterior segment photography.   "
224513|NCT00797316|"     The purpose of the study is to evaluate the blood pressure lowering effect and safety of     aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy     when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting     systolic blood pressure [msSBP] ≥ 160 mm Hg and < 200 mm Hg).   "
224514|NCT00797329|"     Aggressive behavior, both in the form of violence toward others (injury-inflicting or     homicide) or toward oneself (suicide or self-injures) create problems of patient management,     treatment and paroles.      Biological causes of violent crime were hypothesized by Eysenck (1978), who believed that     criminality resulted from a nervous system distinct from that of most people.      The prefrontal cortex, regulates planning of motor acts and executive functions, which are     critical for inhibitory ability and control of impulsive outburst were found to be impaired     in violent subjects (Hoaken et al, 2003; Blair, 2001; Brower and Price, 2001; Filley et al,     2001; Raine et al, 2000; George et al, 2004; Dolan and Park, 2002; Stevens et al, 2003; Raine     and Yang, 2006), especially in impulsive offenders murderers (Raine et al, 1997; 1998).     Violence act influenced by nonplaning outboards definite as impulsive aggression (Linnoila     and Charney, 1999), which one of the most important factor influenced by dangerous behavior     in general (for review: Skodol, 1998, Moeller et al, 2001; Pontius, 2000; 2004; Siever,     2008).      Cholesterol and fats have many roles and may influence brain function and behavior through     modification of membranes; myelin; enzyme function; absorption and transport of fat-soluble     vitamins and toxins; and steroid hormones and through effects on production, reuptake, or     metabolism of neurotransmitters (Boston et al, 1996).      Since 80-th a strong association was found between low cholesterol levels and violent     behavior, an association that was not due to age, race, sex, or diagnosis (Mufti et al, 1998;     New et al, 1999; Alvarez et al, 2000; Golomb et al, 2000; Hillbrand et al, 2000; Troisi and     D'Argenio, 2006; Chakrabarat and Sinha, 2006).      Associations between violent behavior, cognitive functioning and total cholesterol level were     contradicted with difference in samples and behavioral parameters: homicide, homicide     attempts, rape, physical or verbal aggression, complete suicide or suicide attempts, only     partially accounted for each measure of behaviors, suggesting that further investigation is     warranted. Because of the inconsistencies in the available data, we studied retrospectively a     group of criminal offenders with alcohol and drug use. Our analysis of lipid constituents in     serum focused on TC, HDL, LDL, and TG.      Significance of the study. It is possible that cholesterol profile is a biomarker and     potential predictor of violent in patients with polydrug use.      The purpose of this retrospective study is to investigate the correlations between     cholesterol and cognitive profiles in psychiatric patients with violent behaviour. The     demographic and criminal records, clinical characteristics, cholesterol profiles, and     cognitive performance data of these patients will be will be intercorrelated.   "
224515|NCT00797342|"     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of     PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner,     beginning with low doses not expected to have significant biological effects and proceeding     to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored     may be limited by tolerability, and will not exceed levels previously shown to be tolerable     in animals.   "
224548|NCT00797784|"     A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of     Discoid Lupus Erythematosus   "
224524|NCT00797472|"     120 subjects with Hodgkin's disease will be randomly divided into two groups: Group I     receiving R-mabHD and Group II receiving a combination of Adriamycin,Bleomycin,Vinblastine     and Dacarbazine. R-mabHD will be given once a week for eight weeks in a row. The ABVD     combination will be given once every other week for 12 treatments. The hypothesis is that     intervention with R-mabHD will lead to a quicker remission of Hodgkin's disease than the     intervention with a combination of ABVD.   "
224525|NCT00797485|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving bevacizumab together with combination chemotherapy may kill more     tumor cells.      PURPOSE: This phase III trial is studying how well giving induction therapy with bevacizumab     together with combination chemotherapy with or without capecitabine followed by bevacizumab     maintenance therapy in treating patients with metastatic colorectal cancer that cannot be     removed by surgery.   "
224526|NCT00797498|"     The purpose of this study is to collect information from a questionnaire and medical records     to see what effects proton radiation has on cancer and collect and analyze morbidity     outcomes: incidence of Xerostomia (dry mouth) and tumor control.   "
224527|NCT00797511|"     The present study is designed to meet the requirements of the Taiwanese Health Authorities     for registration of ADACEL POLIO in Taiwan.      Subjects will receive one dose of the study vaccine at 6 to 8 years of age. Blood samples     will be taken for antibody titration. The expected total duration of follow-up for each     subject will be 28 days.   "
224528|NCT00797524|"     The main objective of this observational study is to characterize and correlate functional     and structural changes at the retinal level using the Retinal Leakage Analyzer (RLA) and the     Optical Coherence Tomograph (OCT).      To show if it is possible to use OCT as an indirect measurement of leakage, this study will     check, in a primary analysis, for OCT changes between fluorescein leaking and non-leaking     areas (identified by Retinal Leakage Analyzer).      As a secondary objective, changes in RLA and OCT over time (between two consecutive visits)     will be analyzed and characterized.      The results of this study will be used exclusively for scientific purposes.   "
224529|NCT00797537|"     Prospective study with an echography of the 2 knees and radiography of the 2 knees (front and     profile) for each patient. If found calcification on ultrasound further examination with     ultrasound wrists, hips and shoulders.   "
224530|NCT00797550|"     The hypothesis is that Aastrom TRC autologous bone marrow tissue grafts can be safely used     to promote bone healing as part of a single level posterolateral spine fusion surgical     procedure.   "
224531|NCT00797563|"     The purpose of the study was to evaluate the performance of the meter system in the hands of     subjects and healthcare professionals (HCPs). It also evaluated the product user guides in     the hands of untrained subjects.   "
224532|NCT00797576|"     The purpose of this study is to compare Cardiac Magnetic Resonance (CMR) Imaging with     transesophageal echocardiography (TEE) in detecting the presence of LAA thrombi in men and     women with atrial fibrillation presenting for cardioversion.   "
224533|NCT00797589|"     The use of Tetraspan® as prime solution can reduce fluid extravasation after perfusion versus     Ringer acetate. Plasma-adapted HES-solutions produce also less acidosis.   "
224534|NCT00797602|"     The purpose of this study is to collect information from medical records to see what effects     proton beam radiation has on cancer and analyze possible side effects.   "
224549|NCT00797797|"     To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another     drug called pregabalin in people with fibromyalgia.   "
228442|NCT00846066|"     The purpose of this study was to compare the effect of the addition of hands on training by a     pediatric dentist on the pediatric residents skills, confidence, opinions and practice     related to preventive oral health.   "
224535|NCT00797615|"     Over the past 30 years obesity has reached epidemic proportions in the United States (Ogden     et al, 2006). While this epidemic affects all socioeconomic levels, certain racial/ethnic     groups such as Hispanics, are disproportionately affected by obesity and diabetes. The age of     onset of excess obesity in Hispanic females, formerly young adulthood, is now younger.     Childhood obesity poses intermediate and long-term health risks, including: type 2 diabetes,     hyperlipidemia, elevated blood pressure, and metabolic syndrome. Although biological factors     may influence a child's risk for becoming overweight, the home environment has been shown to     be a predisposing and reinforcing contextual factor for unhealthy eating and exercise     behaviors. Since parents are the primary transmitters of Hispanic cultural practices and     significantly influence their children's diet and physical activity behaviors from preschool     through high school, family-based weight-gain prevention interventions are likely to be     effective.      The goal of this implementation study is to contribute to the reduction of racial/ethnic     disparities in obesity and risk of type 2 diabetes by tailoring a recently successful     childhood obesity prevention program originally developed for African American girls to     implement and evaluate with preadolescent Hispanic girls.   "
224536|NCT00797628|"     This is a randomized control trial to determine the efficacy of a multi-modal intervention in     improving smoking cessation processes of care and patient outcomes in community-based primary     care practices. Our Overall Goal is to advance science related to the use and impact of the     Internet in health services delivery, specifically smoking cessation, by targeting primary     care clinical microsystems. A clinical microsystem is defined as the smallest functional     healthcare unit. A clinical microsystem is not simply equivalent to a clinical team of     doctors and nurses, but also the panel of patients cared for by the providers and the     processes of care that are used.   "
224537|NCT00797641|"     The aim of this study is to assess the current management strategies in a pan-European     real-life setting to uncover the unmet need in this area: non-variceal gastrointestinal     bleedings.   "
224538|NCT00797654|"     This study will develop a therapy for men who have sex with men who also have a history of     childhood sexual abuse to reduce behaviors that put them at a high risk of HIV infection.   "
224539|NCT00797667|"     A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with     episodic migraine.   "
224542|NCT00797706|"     The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL     intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it     has an ulcer size reduction effect when administered to individuals suffering from venous leg     ulcers.   "
224543|NCT00797719|"     Malignant pleural mesotheliomas (MPMs) are tumours associated with asbestos exposure     involving the tissue lining surrounding the lung. Radiation therapy (RT) dramatically reduces     the risk of tumour recurrence within the irradiated area (>90%). But patients continue to     succumb to MPMs due to the tumour spreading outside the chest cavity. This may be due to     tumour cells inadvertently contaminating areas outside the chest cavity during surgery. The     study will look at whether giving a short intense course of chest radiation just prior to     surgery will sterilized these tumour cells and thus, avoid or reduce contamination of the     areas outside the chest cavity. The investigators hypothesize that short neoadjuvant     (pre-operative) hemithoracic RT, followed by immediate planned extrapleural pneumonectomy     (EPP) (+/- adjuvant chemotherapy) will reduce the risk of intra-operative seeding and reduce     the incidence of distant metastatic disease.   "
224544|NCT00797732|"     This study is a pilot randomized, sham-controlled trial of acupuncture for Head and Neck     Cancer (HNC) patients with dysphagia after chemoradiation therapy (CRT). The following     hypotheses will be evaluated:      Aim 1. HNC patients will be willing and eligible to participate in a clinical trial of     acupuncture, and be adherent to protocol acupuncture and baseline and follow-up outcomes     testing.      Aim 2. At 20 weeks post CRT and 6 months following the acupuncture treatment: a) the MDADI     total score and its sub-scores will be higher in active acupuncture vs. sham control; b) the     time-to-removal of the feeding tube will be shorter in the active acupuncture vs. sham     control; c) body weight recovery will increase faster in active acupuncture vs. sham control.      Aim 3. At 20 weeks post CRT, the plasma Transforming Growth Factor (TGF)-β1 level measured in     patients treated with acupuncture will demonstrate trends of a decreased level when compared     with a group of similar patients treated with sham acupuncture.   "
224545|NCT00797745|"     SCH 900518 is a potent oral inhibitor of HCV NS3 protease which disrupts hepatitis C virus     (HCV) polyprotein processing. SCH 900518, when added to the current standard of care (SOC),     peginterferon-alfa plus ribavirin, would likely increase the proportion of patients achieving     undetectable HCV-RNA levels and sustained virologic response (SVR). In this study, SCH 900518     would be used in combination with low doses of ritonavir to enhance the levels of SCH 900518     within the body and reduce the number of daily SCH 900518 tablets required. The purpose of     this study is to identify the optimal dose and schedule (once or twice a day) of SCH 900518     plus ritonavir in previously untreated patients with genotype 1 chronic hepatitis C when     given in combination with SOC. The study compares SOC to 6 experimental arms. In the     experimental arms, SOC plus SCH 900518 doses of 200, 400 and 600 mg once daily or 100 mg     twice daily with ritonavir 100 mg once or twice daily will be explored. The benefits of a 4     week lead-in with PegIntron and ribavirin prior to the addition of SCH 900518 will also be     explored.   "
224546|NCT00797758|"     Multicentric evaluation of the reduction of unrelated cord blood transplantation (UCBT)     toxicity by using reduced intensity conditioning (RIC) in patients with acute myeloid     leukaemia.UCBT related mortality and morbidity were limiting factors for the development of     this procedure in adults. Non myeloablative conditioning regimen showed promising results and     prospective evaluation has to be developed to confirm these retrospective data.   "
224550|NCT00797810|"     All patients are treated according to the same therapy regimen. Therapy duration (number of     cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy     consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles. Therapy     for Patients in the 18-55 Age Group        -  Patients in stages III-IV and all patients with mediastinal tumors or extranodal          involvement are administered 6 cycles (A1, B1, A2, B2, A3, B3).        -  Chemotherapy is stopped after 4 cycles (A1, B1, A2, B2) for patients with stage I/ II if          a clear CR has been achieved and there is initially no mediastinal or extranodal          involvement.        -  In cases of refractory or progressive disease after 4 cycles, study therapy is stopped.          These patients are to be given salvage therapy with subsequent stem cell          transplantation. Therapy for Patients older than 55 years        -  The course corresponds to that of patients in the younger age group, but the regimen is          dose reduced (A1*, B1*,A2*, B2*, A3*, B3*). Antibody therapy with anti-CD20 is to be          administered on day 1 of each chemotherapy cycle (A, B). After end of chemotherapy (6 or          4 cycles) 2 more cycles of anti-CD 20 are to be administered to reach a total number of          8 resp. 6 cycles antibody therapy.   "
224551|NCT00797823|"     This study aims to test an insulin and glucagon delivery algorithm designed to be used in     conjunction with a continuous glucose monitoring system. This combined glucose     sensing/hormone delivery approach is a step on the way to eventual development of an     artificial (or automated) pancreas. The insulin and glucagon delivery algorithm is based on     the difference between the current blood glucose and the target glucose (proportional error)     and the rate of change in blood glucose (derivative error), both adjusted for the recent     glucose history. This algorithm is called the Fading Memory Proportional-Derivative (FMPD)     Algorithm. The principal investigator of this study has published previous research regarding     the use of this algorithm and found it to be well-suited to control blood glucose in type 1     diabetic animals. The addition of glucagon was helpful; better glycemic control with fewer     glucose excursions were observed when small intermittent infusions of subcutaneous glucagon     were given during times of impending low blood sugar (Ward et al. 2008).   "
224552|NCT00797836|"     The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in     countries with a high proportion of population having received vaccination with the BCG. We     aim to determine the cost-effectiveness of Quantiferon gold (QTFG), compared to BCG vaccine     to detect latent tuberculosis in exposed healthcare workers (HCWs)   "
224553|NCT00797849|"     The primary purpose of this study is to determine if the group using Farabloc shows a greater     reduction in pain levels than the group not using Farabloc at 6-week, 12-week and 1-month     post treatment follow-ups.   "
224554|NCT00797862|"     This study will compare the safety and efficacy of initial combination treatment with     aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine     in patients with hypertension.   "
224555|NCT00797875|"     To investigate immediate and short term effects on angle of knee flexion, intensity of pain,     strength of the knee extensor, and function of the lower extremity by using PNF stretching     technique in patients with total knee arthroplasty.      hypothesis:TKA patients may increase ROM after PNF stretching   "
224556|NCT00797888|"     To address and reduce population-attributable risk due to elevated HbA1c, the New York City     Department of Health and Mental Hygiene (DOHMH) developed an innovative HbA1c registry, which     requires all major laboratories to report HbA1c results electronically. We propose to utilize     this registry to conduct a randomized controlled trial addressing the following specific     aims: 1) to evaluate the incremental effect of a tiered and tailored, patient-centered     telephone intervention, in English and Spanish, on the mean HbA1c levels beyond that achieved     with print materials mailed to patients and providers by the DOHMH registry intervention; 2)     determine what patient demographic and psychosocial factors mediate the effect of the     interventions; and 3) provide estimates of implementation costs of the tiered, tailored     telephone intervention for comparison with the print intervention. The study outcome will be     change in HbA1c values from the registry records from baseline to one-year     post-randomization. A total of 941 individuals with diabetes will be needed to provide 83%     power to detect a statistically significant difference (p<0.05) between groups of at least     0.3% in absolute HbA1c. Intervention cost data will be evaluated for translation of findings     and scalability. At study end, we will know the extent to which this intervention will     improve metabolic control in a low-income, multi-ethnic sample who are part of the DOHMH     HbA1c registry in the South Bronx, New York. These findings will inform public health     policies and practices in New York City, as well as other urban areas throughout the nation.   "
224557|NCT00797901|"     The purpose of this study was to examine the effect of a new disease management model for     depression, the Collaborative Depression Management Program (CDMP), designed to improve     clinical outcomes and increase depression treatment in general medical settings.   "
224558|NCT00797914|"     The purpose of this study is to evaluate a handheld Colonoscopy Force Monitor(CFM™), a     push-pull force and torque measuring device, that grips the shaft of the colonoscope and     wirelessly transmits and records all the forces applied by the endoscopist during     colonoscopy.   "
224559|NCT00797927|"     we aim to examine whether a representative atypical antipsychotic, quetiapine, has different     effects from conventional antipsychotics on the magnetic resonance spectroscopy (MRS) markers     in schizophrenia patients.   "
224560|NCT00797940|"     A Phase II, multi-center, open-label, single-arm study in up to 42 subjects with first     recurrence or progression of GBM at up to 12 sites in Australia, Europe, Israel, and the     United States. Subjects will receive intratumoral infusion of PRX321 administered via     convection-enhanced delivery (CED) at a concentration of 1.5 μg/mL and a total volume of 60     mL over 2 to 7 days.      Primary Objective:      To evaluate the efficacy (expressed as overall survival at 6 months [OS-6]) of intratumoral     infusion of PRX321 in subjects with first recurrence or progression of glioblastoma     multiforme (GBM).      Secondary Objectives:      To assess the safety of intratumoral infusion with PRX321 in subjects with recurrent or     progressive GBM.      To evaluate objective response rate (ORR), duration of response (DR), overall survival (OS),     and progression-free survival (PFS).      Tertiary Objective:      To evaluate the relationship of observed infusate distribution with clinical and radiological     responses.   "
224565|NCT00798005|"     Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs     due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be     regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an     extremity and often causes lifelong disablement from a painful leg. The clinical consequences     of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in     the distal limbs.A variety of medical therapies have been investigated for patients with     PAOD. There is currently no evidence to suggest that any medical therapy is effective for     patients with rest pain and/or ischemic ulcers.      Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a     improvement in clinical and hemodynamic status in patients with severe PAOD   "
224566|NCT00798018|"     It has been proven that tracheal tube inflated with lidocaine could decrease the     post-intubation sore throat in nitrous oxide anesthesia. In the study, the investigators     would like to evaluate the effect of lidocaine inflation in non-nitrous oxide anesthesia and     compare the effect of tetracaine, the best mucosal local anesthetics with lidocaine.   "
224567|NCT00798031|"     Following the loss of teeth, the alveolar bone formed in response to the eruption of the     teeth is gradually resorbed by the body. In conventional dental implant therapy, a wide     safety margin of uninterrupted healing (3-6 months) following placement of the implants is     used to assure a predictable survival of the implants (on the order of > 90%). In the past     few years, there have been multiple studies documenting with improved implant surface     technologies available, that dental implants can be put into function far sooner than     conventionally thought. The investigators are currently performing recalls on subjects     treated in a research protocol at the University of Iowa (YAOSS-0001; IRB 200305001). Since     this initial study, a shortened version of the implant device has been developed and has     obtained FDA clearance (FDA 510k 063779 clearance letter dated April 27, 2007) for a 4mm     diameter by 6mm in length dental implant. In a case study the investigators are proposing to     repeat the same protocol as used in the initial trial with the following exceptions: only     this one implant type will be used, no bone compression surgical techniques will be used     (referred to as osteotome indirect sinus lifting). Our initial trial has documented good     performance with minimal bone loss and a 98.3% cumulative survival rate.      This will be an open, prospective case-series clinical documentation study to document the     clinical efficacy of the 4.0mm diameter x 6 mm in length implant (Astra Tech Dental Implant,     Fixture OsseospeedTM ) in the treatment of subjects missing teeth in the upper jaw. A minimum     of two but preferably three implants shall be considered for each surgical site. A total of     20 subjects fulfilling all inclusion criteria will be enrolled. Subjects will have a complete     diagnostic work-up performed and assessment for eligibility in the study by both a     Prosthodontist and Surgeon. Subjects will then have the implants placed in an out patient     basis at the College of Dentistry. The subjects will not wear a conventional removable     partial during the initial six weeks of healing. At six weeks, an assessment of the implants     shall be made by the surgical and restorative team and if a set of safety benchmarks are met,     provisional crowns will be made to place the implants into clinical function (mastication).     Over the first year, the provisional crowns will be periodically removed and a series of     clinical measurements and mobility measurements made. At the end of 1 year following     placement, the permanent crowns or bridgework will be constructed and the subject followed     annually for another four years (five years total from placement). A total of 15 clinical     visits are estimated per subject.   "
224568|NCT00798044|"     The purpose of the study is to determine if a semi-automated quality improvement system that     provides addiction counselors with feedback on their average treatment satisfaction and     therapeutic alliance (as rated by patients currently in treatment) is superior to no feedback     in 32 community-based outpatient addiction treatment clinics.   "
224570|NCT00798070|"     This is an adjuvant, open, prospective, randomized study to compare:      A. Individually tailored and two weekly dosed epirubicin + cyclophosphamide followed by a     three weeks break followed by biweekly and tailored docetaxel (dtEC→dtT) given every second     week, to      B. Fixed dosed and three weekly epirubicin, cyclophosphamide and 5-fluorouracil, followed by     fixed dosed and three weekly docetaxel (FEC→T).      Patients with primary node-positive or high risk lymph node negative breast cancer will be     eligible for the study.      The primary objective of the phase 3 study is to compare breast cancer relapse-free survival     (BCRFS) between the dtEC→dtT and FE100C→T. To detect a five-year BCRFS difference of 0.710 to     0.790 about 1000 patients per arm will be needed. They will be recruited during four years     and followed another two years for breast cancer events.      Secondary objectives are to compare        1. Distant disease-free survival (DDFS)        2. Event-free survival and        3. Overall survival        4. Health-related quality of life and toxicity analyses according to CTC        5. Outcome in relation to tumour biological factors and polymorphism patterns             1. RFS in relation to the Sorlie classes using immunohistochemical markers and/or gene               expression profiling comparing A vs B arm             2. RFS with receptor positive disease (analyzed in the local laboratories as described               in the CRFs and also analyzed as continuous variables) in the comparison between               the A- and B- arms.             3. RFS with high and low proliferation, respectively, (analyzed in the local               laboratories as described in the CRFs and also analyzed as a continuous variable,               or centrally analyzed), in the comparison between the A- and B-arms.             4. RFS in relation to HER-2/neu status (analyzed in the local laboratories as               described in the CRFs) in the primary cancers in the comparison between the A- and               B-arms and analyzed whether trastuzumab was given in sequence or concurrently.             5. RFS analyzed in relation to other molecular markers (e.g. gene expression               profiling/ sequencing) in the primary cancers and SNPs signatures in normal DNA               (related to toxicities for EC/FEC and docetaxel components, respectively, and given               dose levels and outcome in relation to these factors and in relation QoL) to               outcome per arm.             6. RFS analyzed in relation to tumour associated lymphocytes and Y-box binding protein               in the comparison between the A- and B-arms.      Tumour tissue will be obtained and stored for studies of prognostication and therapy     prediction.      Last patient randomized was September 2011.   "
224571|NCT00798083|"     To investigate if topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic     lecitine organogel (AKL in PLO gel) can improve management of neuropathic pain from radiation     skin reactions adjunctively or better than standard treatment.   "
224572|NCT00798096|"     Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19     patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients     exhibit a response at Week 8 or later in the study. All enrolled patients will be treated     with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor     measurements using CT and PET (when indicated) scans and physical exam at baseline, and scans     and physical exam of all disease-involved areas every 8 weeks until progression. Safety will     be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All     patients will have a follow-up visit 30 days following last study drug treatment. Blood     samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol     defined intervals.   "
224573|NCT00798109|"     Schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %,     involving both genetic and environmental risk factors. Prospective studies have shown that     heavy use of cannabis in adolescence moderately increases the risk of developing     schizophrenia. Many data have also suggested that the co-occurrence of cannabis abuse in     patients with schizophrenia has a deleterious impact on the clinical outcome of     schizophrenia. Cannabis abuse by schizophrenic patients is a significant public health     problem for which there is no empirically validated treatment. We are presently studying the     efficiency of motivational therapy on cannabis consumption in patients with schizophrenia.   "
224899|NCT00789373|"     This study will compare progression-free survival in patients with advanced non-squamous     non-small cell lung cancer. Patients who do not progress following 4 cycles of induction     treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance     pemetrexed or placebo.   "
224574|NCT00798122|"     Approximately 600,000 women are treated for acute coronary syndrome (ACS) annually in the US.     ACS includes heart attack and a milder form called unstable angina. Many of these women have     angiograms of which 14-39% show no significant coronary artery disease (CAD, cholesterol     plaque accumulation in arteries of the heart). The remaining majority of women with ACS have     cholesterol plaque buildup which appears severe enough on angiography to limit blood flow to     the heart.      It is difficult to advise women with heart attacks and no major heart artery blockages on     what to do if chest pain happens again. Additional studies are needed to find out why this     sort of heart attack happens and to help doctors understand how to treat patients who have     this problem in the best possible way.      Some women with heart attacks who have no major blockage in heart arteries have cholesterol     plaque in the arteries of the heart cannot be seen on angiography but can be seen using a     newer technique called intravascular ultrasound (IVUS). IVUS involves creating pictures of     the artery walls using ultrasound (sound waves) from within the artery itself. In some women     without major heart artery blockage, heart attack is caused by low blood flow due to disease     of smaller blood vessels which cannot be seen on angiography or IVUS. This problem can be     found using magnetic resonance imaging (MRI), which can show blood flow to the heart. MRI may     also be used to show where the heart has been damaged. The pattern of damage could suggest     that a heart attack in a woman, who has no badly blocked heart arteries, happened for one (or     more) of these reasons or another reason.      The Study of Women with ACS and Non-obstructive CAD (SWAN) will use IVUS and MRI to help     determine the reasons for heart attacks in women with no major blockages in heart arteries.   "
224575|NCT00798135|"     Cancer cells need to be able to make new blood vessels in order to keep growing. This is     called angiogenesis. In a laboratory setting, the drug itraconazole was shown to help stop     the growth of new blood vessels (anti-angiogenesis). It is hoped that itraconazole will     prevent new blood vessels from forming in humans too.      The purpose of this study is to look at how the body processes and breaks down itraconazole     (called pharmacokinetics). This study will also measure markers in your blood to see if     itraconazole stops new blood vessels from forming. The safety of itraconazole will also be     tested to see what effects (good and bad) it has on you and your breast cancer.   "
224576|NCT00798148|"     This trial is studying how well iodine I 131 metaiodobenzylguanidine together with     combination chemotherapy works in treating patients who are undergoing an autologous     peripheral stem cell for high risk or relapsed neuroblastoma.   "
224577|NCT00798161|"     The objective of the randomised part of the study is to investigate the efficacy and safety     of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug     naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic     patients with insufficient glycaemic control. For the open-label part of the study the     objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic     patients with very poor glycaemic control for 24 weeks   "
225068|NCT00792012|"     The purpose of the study is to find out the highest dose per fraction of hypofractionated     Intensity-Modulated Radiation Therapy (Hypo-IMRT) that can be safely given with temozolomide     chemotherapy.   "
224578|NCT00798174|"     When implantable cardiac defibrillators are implanted (ICDs), the defibrillation threshold     (DFT), of the amount of energy required to effectively terminate life-threatening arrhythmias     is determined. The device is then programmed to discharge a larger amount of energy in order     to provide a safety margin. In some patients, the DFT is so high, that an adequate safety     margin is not programmable. Placement of a defibrillation lead in the azygos vein has been     found to be helpful in these patients. This goal of this trial is to attempt to quantify the     reduction in the DFT that results from the   "
224579|NCT00798187|"     The goal of this research study is to learn if a support group program is acceptable for     patients with prostate cancer or patients with breast cancer. Researchers also want to learn     if the characteristics of the members of the support group program can have an effect on the     quality of life of other members of the support group program. Support group programs will be     conducted separately for prostate cancer patients and breast cancer patients.   "
224580|NCT00798200|"     This project will create a community based exercise program for well cancer survivors. The     goal is that the YMCA will gain the competence to work with this unique population in a safe     and productive manner.   "
224581|NCT00798213|"     Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or     gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive     SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in     participants with AML and participants with ALL. Part 2 of the study will determine the     activity of SCH 727965 treatment in participants with AML who experienced disease progression     after standard treatment with gemtuzumab ozogamicin during Part 1.   "
224582|NCT00798226|"     The aim of this study is to prevent asthma and allergies in childhood by supplementation with     fish oil (n-3 fatty acids) to the mother during pregnancy. Paticipants are mother and     children participating in the ABC-(Asthma Begins in Childhood)cohort. Mothers are recruited     during pregnancy and receive supplement with n-3 fatty acids or olive oil (placebo) from week     24 of gestation to 1 week after delivery. The child is followed with acute and planned visit     at the research unit and diagnosis of disease is done in the research unit according to     predefined algorithms.   "
224583|NCT00798239|"     This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as     compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with     degenerative disc disease (DDD) at one level from L2-S1.   "
224584|NCT00798252|"     To determine safety and maximum tolerated dose of brivanib alaninate when administered in     combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel     chemotherapy to subjects with advanced or metastatic solid tumors   "
224597|NCT00798421|"     The purpose of this study is to investigate whether influenza can be reliably transmitted     from children to susceptible contacts in a health care setting. The goal is to develop a     transmission that can then be used to assess interventions to prevent transmission      Research objectives:      To develop a model to investigate the frequency of influenza transmission from an infected     child to a susceptible health care worker      Research Hypotheses:      Influenza viruses can be transmitted from infected children to exposed health care workers   "
224924|NCT00789698|"     Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This     clinical study is designed to test the hypothesis that lurasidone is effective, tolerable,     and safe as compared with quetiapine XR long term among schizophrenic outpatients with     chronic schizophrenia.   "
224585|NCT00798265|"     Background:        -  Human papilloma virus (HPV) is a common sexually transmitted disease. There are more          than 100 different HPV types, and both males and females can get HPV infection. Most          people do not have any symptoms when they become infected and are able to get rid of the          infection on their own. However, they can still become re-infected with the same or a          different HPV type, and in some people HPV infection persists.        -  Persistent HPV infection is associated with the development of precancerous lesions and          cancer. HPV types are classified as either high risk or low risk based on whether their          persistence will lead to cancer.        -  Patients who have suppressed immune systems are at a higher risk for HPV-related          complications. They are more likely to contract multiple HPV types and have more          persistent infection that can lead to precancerous lesions or cancer, which are then          difficult to treat and often recur.        -  A recently approved vaccine for HPV induces immunity to HPV 6, 11, 16, and 18. It was          shown to be highly effective in preventing infection with these HPV types, and is          approved for use in females 9 to 26 years of age. However, much less is known about the          vaccine s ability to induce immunity in males or individuals with suppressed immune          systems.      Objectives:      - To investigate whether the HPV vaccine is safe to give and able to induce immunity in both     female and male adolescents and young adults with HIV infection compared to healthy,     HIV-negative persons of the same age.      Eligibility:      - Males and females, 12 to 26 years of age, divided into three groups: (1) Healthy and     HIV-negative, (2) HIV-positive and on antiretroviral therapy, and (3) HIV-positive and not on     antiretroviral therapy.      Design:        -  Before beginning vaccination, participants will have a complete physical examination and          blood drawn for routine blood tests, special tests of the immune system, antibody tests,          and an HIV test.        -  HPV vaccine will be given by injection into the muscle at 0, 2, and 6 months, according          to the standard vaccination schedule.        -  Patients with HIV infection will be monitored for a week following the first injection          to test the level of HIV in the blood 3 days and 5 days after the first injection.        -  Participants will also be asked to fill out a 10- to 15-minute Web-based survey about          awareness, health behaviors, and personal choices related to risk factors for HIV, HPV,          and other sexually transmitted diseases. Participants are not required to fill out the          survey to receive the vaccine.        -  The total duration of the study is 4 years. During the first year of the study,          participants will return for six additional 1-day visits at months 1, 2, 3, 6, 7, and          12. Participants will return for 1-day visits every 6 months for the remaining 3 years.   "
224586|NCT00798278|"     A great controversy exists about which is the best method to perform the evacuation of the     collection. The purpose of this study is to evaluate which is the best initial treatment to     drain complicated parapneumonic empyema (stages II and III) in children: the present study     raises a hypothesis of equivalence between both arms of treatment (chest drainage plus     intrapleural urokinase or videothoracoscopic debridement).   "
224587|NCT00798291|"     To evaluate whether AN777 with or without exercise affects muscle mass change in elderly     subjects.   "
224588|NCT00798304|"     The primary purpose of this study is to evaluate the safety and immunogenicity of an     investigational meningococcal B vaccine in healthy infants.   "
224589|NCT00798317|"     This trial will evaluate the safety and efficacy of microplasmin, administered as an     intravitreal injection, in subjects with focal vitreomacular adhesion. In previously     performed clinical trials, some patients treated with intravitreal microplasmin have had     resolution of their underlying condition, including macular hole closure, without need for     vitrectomy. This clinical trial is justified because the sponsor believes the potential     benefits outweigh the potential risks.   "
224631|NCT00798863|"     The study addresses a problem that face surgeons who perform key-hole surgery to resect the     submandibular salivary gland. The problem is the narrow space available around that gland.     This does not allow for a safe operation. The study aims to evaluate a new, two step     resection technique, that should overcome this difficulty.   "
224590|NCT00798330|"     Patients who are preparing to receive chemotherapy are asked to have their teeth cleaned     before starting treatment as standard of care. This research study is being done to see if     having dental cleaning increases the chances of bacteria from the mouth getting into the     blood stream. It is also being done to see if these bacteria can cause blood stream     infections in people who have a Central Venous Catheter (CVC),often called a port or a     PICC, placed for giving chemotherapy. It is a well-established fact that we introduce     bacteria from the mouth into the bloodstream with activities of daily life including chewing,     flossing and brushing teeth. This introduction of bacteria into the blood stream may cause     bacteria to stick to the central venous catheter and serve as a source of infection when the     immune system is weakened by cancer. The purpose of this research study is to see if we can     find bacteria from mouth in blood that is drawn through the CVC, during, and after a dental     cleaning procedure. This way, we will be able to assess whether or not this is a potential     health risk to cancer patients.   "
224591|NCT00798343|"     Vaccination is the principal means of combating epidemic and pandemic influenza. As vaccines     induce relatively strain-specific and short-lived antibody responses, annual immunisation     with regularly updated vaccine is recommended for seasonal influenza, but would not be     expected to protect against a pandemic event. In clinical trials among young adults, at least     two doses of avian influenza H5 or H9 subunit vaccine are needed to induce moderate antibody     responses. However, studies including older subjects have unexpectedly found that some people     aged over 65 yrs have pre-vaccination neutralising antibody to influenza H5 and H9     respectively. These subjects mount a robust antibody response to single dose H5 or H9     pandemic vaccine, suggesting that they are effectively primed to at least some strains of     avian influenza.      This exploratory proposal focuses on those elderly subjects whose immune systems already     exhibit antibodies to H5 with a goal of investigating the humoral and cellular basis of the     immune response to seasonal and pandemic vaccination. We will examine neutralising antibody     responses to a range of human and non-human influenza viruses before and after seasonal and     pandemic vaccination and evaluate cellular B and T cell immune responses before and after     pandemic H5 vaccination   "
224592|NCT00798356|"     Studies in the past have shown that yoga could relieve stress which is the most common     trigger for recurrent episodes of atrial fibrillation. Breathing exercises in yoga are found     to influence the autonomic nervous system (particularly parasympathetic) and thus reduce     palpitations. This study hypothesizes that patients with atrial fibrillation might benefit by     practicing yoga. Yoga may also help to better control heart rate and rhythm when used in     combination with usual medical management.   "
224593|NCT00798369|"     This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the     management of acute flare in gout patients who are contraindicated to Non-Steroidal     anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the     corticosteroid triamcinolone acetonide.   "
224594|NCT00798382|"     The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of     normal term infants to two experimental soy-based formulas, relative to a commercially     available soy-based formula.   "
224595|NCT00798395|"     This trial is to investigate the effect on next-day driving performance and psychomotor     performance in healthy volunteers.   "
224596|NCT00798408|"     We propose to critically evaluate the effects of energy-yielding fluids and solids on acute     appetite variables, daily food intake, and specific endocrine and metabolic response to food     in the elderly. The results of these studies will provide further evidence to support that     nutrition may provide safe and effective non-pharmacological therapies to counter the     compromised regulation of energy balance experienced by many elderly people.   "
224598|NCT00798434|"     The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at     unwanted times and has been shown to help patients with overactive bladder syndrome pass     urine less frequently than before treatment. It is postulated that this drug will also prove     effective in elderly patients (aged > 65 years) and that the ability to change dose between 4     and 8mg will allow each patient to have an optimised treatment.   "
224599|NCT00798447|"     Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3     PUFA on post-operative inflammatory processes.   "
224600|NCT00798460|"     The purpose of this study is to determine the optimal antiviral treatment for lamivudine     resistant hepatitis B patients.   "
224601|NCT00798473|"     Background:        -  Up to 30% of children and adolescents with Crohn's disease have decreased bone strength,          or decrease bone density, called osteopenia.        -  Bisphosphonates are a group of drugs that have been well studied and found to be          effective in the treatment of osteopenia in menopausal women.        -  Zoledronate is a very potent third generation bisphosphonate, that is safe and easy to          administer, and has been found effective in the treatment of menopausal women with          osteopenia.      Hypothesis: The investigators hypothesize that zoledronate can improve bone density in     children and adolescents with Crohn's disease with osteopenia.   "
224602|NCT00798486|"     The purpose of this study was to assure that consumers can successfully use the new version     of A1CNow+ along with revised instructional materials.   "
224603|NCT00798499|"     The purpose of this study is to collect reference data in patients with haemophilia. The     study will also collect and store blood samples for potential future exploratory research in     the disease area.   "
224604|NCT00798512|"     The purpose of this study is to detect new ischemic lesions after carotid artery stenting     (with the Cristallo Ideale stent), in patients with high grade carotid artery stenosis, by     diffusion-weighted magnetic resonance imaging (DW-MRI), using the endovascular proximal flow     blockage (Mo.Ma device) for cerebral protection.   "
224605|NCT00798525|"     The purpose of this study is to test the hypotheses that argatroban significantly increases     efficacy and safety of renal replacement therapy measured as life time of haemodialysis     filters as compared to lepirudin   "
224640|NCT00798993|"     This study aims to examine the effect of 25 hydroxyvitamin D supplementation and a structured     exercise program on the exercise capacity and quality of life of haemodialysis patients with     25 hydroxyvitamin D insufficiency.   "
224641|NCT00799006|"     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The     purpose of this study is to characterize the safety, tolerability, pharmacokinetics and     pharmacodynamics following a single oral dose.   "
224606|NCT00798538|"     The purpose of this study is to assess the feasibility, cost and effectiveness of     interventions designed to integrate buprenorphine treatment for opioid dependence into HIV     primary care in ten HIV care centers in the U.S.      In the site led by Dr. Altice, we compare two models of providing HIV care and buprenorphine     treatment. Assignments are based on participants' city of residence. In the onsite     (integrated care) model, participants receive buprenorphine, substance abuse counseling and     HIV care at one location: the Waterbury Hospital Infectious Disease Clinic. In the off-site     model (non-integrated care) buprenorphine induction, substance abuse counseling, and HIV care     will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS     Program, and patients' own HIV providers, respectively. Data is collected from interviews     with participants, reviews of medical records, and surveys and interviews with clinicians.   "
224607|NCT00798551|"     Hypertension is a very common disease, affecting approximately 65 million people in the     United States. As many as 30 % of people with hypertension, approximately 20 million     individuals, remain undiagnosed. As many as one third of patients seen in ED were noted to     have elevated BP readings in prior studies. Approximately 5% of emergency department (ED)     patients have severely elevated blood pressure. Prior studies suggest that as many as two     thirds of ED patients with elevated BP can benefit from further therapy or closer clinic     follow-up. However primary care follow-up after ED discharge with an elevated BP is     surprisingly low. The purpose of this study is to measure the follow-up rate after the ED     visit in individuals identified with elevated blood pressure after a brief counseling     regarding risks of elevated blood pressure.   "
224608|NCT00798564|"     The overall aim is to explore pathophysiological factors related to airway     hyperresponsiveness to direct and indirect provocation stimuli in athletes with different     sport activities, with special focus on epithelial reaction linked to CC16 and to eicosanoid     related inflammatory response. The investigators also wish to compare indirect testing done     as hyper osmotic challenge with Mannitol compared to a defined sport specific exercise     challenge.   "
224609|NCT00798577|"     The primary objective of this study is to investigate the initial antibiotic effects in the     treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.   "
224610|NCT00798590|"     The goal of this present proposal is to examine the efficacy of GLP-1 administered to control     blood glucose in critically ill patients.   "
224611|NCT00798603|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Giving pemetrexed together with     carboplatin and bevacizumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving pemetrexed together with carboplatin     and bevacizumab works as first-line therapy in treating older patients with stage IIIB or     stage IV non-small cell lung cancer.   "
224612|NCT00798616|"     The purpose of the study is to determine whether corticosteroids are beneficial to children     with bronchiolitis whose breathing gets better after being given a breathing treatment with     albuterol.   "
224613|NCT00798629|"     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune     response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with metastatic melanoma.   "
224614|NCT00798642|"     The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will     maintain remission in patients affected by Ulcerative Colitis.   "
224696|NCT00786539|"     The objective of this research protocol is to continue investigation of the nature and     prevalence of mitochondria disease and to aid patients and health care providers in the     understanding of these complex disorders.      This research study brings together many clinical sub-specialists to address the etiology of     these disorders and to develop more effective approaches for their diagnoses and more     reliable prognoses.   "
224615|NCT00798655|"     The objectives for this study is as follows:        -  Primary:             -  To evaluate the progression-free survival of locoregionally advanced (stages               III/IV) SCCHN patients undergoing postoperative chemoradiotherapy with panitumumab.        -  Secondary:             -  To evaluate the overall survival, event-free survival, and toxicities.             -  To correlate efficacy parameters with 1) EGFR and downstream pathway activation, 2)               FcyR polymorphisms, and 3) serum cytokine profiles. More specifically, the aim is               to demonstrate the usefulness of biomarkers (downstream signaling molecules, FcyR               polymorphisms, or tumor and serum cytokine(s) in predicting progression-free               survival in patients with SCCHN treated with the above treatment. Specific               biomarkers that relate to Epidermal Growth Factor Receptor and angiogenesis,               including EGFR, pEGFR, Src, pMAPK, pSTAT3, pSTAT5, pSTAT1, pAKT, p38, p21, p27,               PARP, E-cadherin, p-ErbB3, Ki67, VEGF, and IL-8, using reverse phase protein               microarrays (RPPA) will be tested in baseline archival paraffin-embedded tumor               tissue. To collect tumor tissue from pretreatment biopsies for cytokine/chemokine               and immune biomarker studies on tumor tissue. We plan to investigate the expression               of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis               biomarkers. In addition, EGFR polymorphisms will be studied in tumor tissue samples               and serum. Additional studies may be performed in the future. Some of these studies               may be performed by Amgen.   "
224616|NCT00798668|"     The purpose of this research study is to determine the effects of food supplements and     strength training on appetite, the amount of energy expended, and body composition.   "
224617|NCT00798681|"     This is an international prospective randomized multicenter open-label controlled study. The     primary center will be Fernandes Távora Hospital (Fortaleza, Ceará). The aim of this study is     to investigate the effects of closed parenteral nutrition systems when compared to open     parenteral nutrition systems in terms of several clinical outcomes.   "
224656|NCT00799201|"     The purpose of this study is to determine if enteral naloxone is more effective than a     traditional bowel regimen in the prevention and treatment of constipation and impaired     gastric motility in critically ill trauma patients.   "
224618|NCT00798694|"     The purpose of this research study is to determine whether one glaucoma eye drop is less     likely to cause changes to the surface of the eye (conjunctiva) than another. The     investigators plan to determine this theory by comparing the results when a patient is using     two different prostaglandins, Xalatan and Travatan Z. (Both of these drops are presently on     the market and are approved by the FDA for the treatment of eye pressure). Because this study     will be masked, the clinician who reviews the study results will not know what study drop     each patient has been using.   "
224619|NCT00798707|"     The primary purpose of this study is to compare the antidepressant efficacy and safety of two     doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder.     The study will also assess changes in sexual function and general and functional quality of     life outcomes.   "
224620|NCT00798720|"     The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the     third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy)     and tolerability of this regimen.   "
224621|NCT00798733|"     The purpose of this study is to define the outcomes, both patient based and radiographic, for     sacral fractures based upon injury pattern, displacement, and treatment. This will aid the     orthopaedist in determining the best course for those patients with mild to moderate     displacement. Multiple centers will be included and not asked to change their protocols for     management. The prospective evaluation will gather specific data points on mechanism of     injury, displacements, position at union, and disease specific and general health outcomes.   "
224622|NCT00798746|"     The purpose of the current study is to assess the role of pyloric drainage procedure on     altering the reflux effect on the quality of life in patients who underwent esophagectomy.     Researchers hypothesize that the patients who underwent minimally invasive esophagectomies     without pyloric drainage experience less reflux symptoms and therefore have a better quality     of life.   "
224623|NCT00798759|"     The purpose of this study is to compare two ophthalmic solutions in patients with open-angle     glaucoma or ocular hypertension.   "
224624|NCT00798772|"     Infection with human immunodeficiency virus (HIV) causes decline in immunity or the ability     to fight infection and progresses to acquired immunodeficiency disease (AIDS). Anti-HIV drug     treatment has improved the prognosis of persons with HIV infection, but is expensive and     potentially toxic. Low micronutrient levels occur in the blood even in early stages of HIV     infection and increase risk of a poorer prognosis, but the role of micronutrient and     antioxidant supplements in medical management of HIV/AIDS is not well defined. The proposed     clinical trial aims to assess if supplementation of untreated HIV-infected adults with a     micronutrient and antioxidant preparation can delay decline in immunity or disease     progression or start of anti-HIV drug treatment compared with supplementation with standard     multivitamins. If the findings are positive, the study has implications for health and health     care savings.   "
224625|NCT00798785|"     The present proof of concept study addresses the following specific aims:      The general objectives of this work are:        1. To increase and maintain the functional beta-cell mass after islet transplantation under          a condition of low-dose tacrolimus        2. To co-investigate the potential of alternative sites for encapsulated beta-cells   "
224626|NCT00798798|"     The purpose of this study is to assess whether brief use of an externally implantable tissue     expansion device following excisional skin cancer surgery will significantly reduce the     diameter of the final wound defect, and hence the length of the final linear primary closure.     The secondary objective is to assess the functional benefits, if any, associated with use of     the tissue expander.   "
224627|NCT00798811|"     -  Study No.: KSPNO-S-081 Reduced-dose Craniospinal Radiotherapy Followed by High-dose          Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk          Brain Tumor        -  Study No.: KSPNO-S-082 High-dose Chemotherapy and Autologous Stem Cell Rescue in Infants          and Young Children with Newly Diagnosed High-risk Brain Tumor To Avoid or Reduce          Craniospinal Radiation        -  Study No.: KSPNO-S-083 High-dose Chemotherapy and Autologous Stem Cell Rescue in          Children with Recurrent Brain Tumor or Non-germinomatous Germ Cell Tumor with Inadequate          Response to Conventional Treatment   "
224697|NCT00786552|"     The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed +     paclitaxel in patients with recurrent/advanced follicular, papillary or anaplastic thyroid     cancer.   "
224628|NCT00798824|"     This clinical pilot trial is being conducted to learn more about the infant's feeding     behavior while being fed by indwelling nasogastric tube placement or by intermittent oral     tube placement.      Healthy preterm infants who are transitioning from gavage to oral feedings via oral     intermittent tube insertion may achieve full oral feeds by bottle/breast at an earlier     gestational age than infants feeding with indwelling tubes and may be ready for earlier     discharge.   "
224629|NCT00798837|"     This trial uses a type of radiotherapy called intensity modulated radiotherapy (IMRT), which     is able to deliver the radiation to the prostate while delivering less dose to the     surrounding normal organs compared with standard 3D conformal radiotherapy presently used at     the BCCA. This trial will use RapidArc IMRT, which is a new way of delivering IMRT, where the     radiation dose is delivered in a single rotation of the radiotherapy machine around the     patient. This new method of delivering IMRT has been shown to be at least as good as     conventional IMRT at delivering the dose, and takes less time to do so.      The aim of this study is to deliver a higher radiation dose to the prostate gland than the     standard treatment while not increasing dose to the normal organs. In this way, it is hoped     that the likelihood of the cancer coming back will be reduced without causing an increase in     side-effects.   "
224630|NCT00798850|"     Intermittent Claudication (IC)is a common condition characterised by pain in the muscles of     the legs on exertion caused by hardening of the arteries and a reduced blood supply. The     investigators know that the vast majority of people suffering from this condition remain     stable and do not deteriorate, and thus in general the viability of legs is not at risk. The     main aim of treatment, therefore, is to try and improve walking thus reducing the impact this     problem has on patients life style. There are many methods of management of intermittent     claudication, but the investigators do not know which produces the best results. This study     aims to compare the short and medium term outcomes of exercise programmes, percutaneous     transluminal angioplasty and a combination of the two treatments for patients with     intermittent claudication.   "
224632|NCT00798876|"     Studies on patterns of how many men get prostate cancer in other countries show that     environment contributes to the high incidence of prostate cancer in the United States.     Epidemiology studies suggest that this influence may be reduced by the diet of men at risk of     getting prostate cancer. Although the exact nature of the effects of diet are not completely     known, the amount of fat eaten appears to affect the number of men who get prostate cancer.     The type of fat also seems to matter. Eating more of a type of fat called omega-3     polyunsaturated fat is associated with decreased prostate cancer risk. Omega-3 fat comes from     fish and is quite different from the type of fat from animals and vegetables (omega-6 fat).     Because the exact mechanism of this reduction in prostate cancer risk is not known, no blood     test indications, called markers, have been discovered that would show the effect working.      Study doctors designed this study to try to find markers in the blood tests of men who have     prostate cancer, and to find out if a diet supplemented with omega-3 type fat from fish oil     helps reduce those markers, hence indicating that it helps reduce the cancer in these men.     These men will be compared to men with prostate cancer whose diets do not contain the     fish-oil fat.      The men chosen will have prostate cancer and be scheduled for operations to have their     prostate glands removed. They will be chosen randomly to be given the fish-oil diet or a     regular Western diet for comparison for 4 to 8 weeks. Their blood will be checked at the     beginning of the diet. After the 4-to-8-week period, they will have their operations. Their     blood will be checked again and a sample of their removed prostate will be examined to tell     if the diet had any effect on the cancer and its markers.   "
224633|NCT00798889|"     The objective of this protocol is to provide SU011248 treatment for patients who have     participated in a SU011248 protocol and are eligible to enter this protocol   "
224634|NCT00798902|"     This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as     compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with     degenerative disc disease (DDD) at one level from L2-S1.   "
224635|NCT00798915|"     An intestinal hormone called Glucose-dependent Insulinotropic Polypeptide (GIP) is released     into the blood immediately after ingestion of a meal and plays an important role in     regulating blood sugar levels. However, GIP is not active in persons with type 2 diabetes     mellitus (T2DM) which is also known as adult onset or non-insulin-dependent diabetes. This     study is being conducted to determine whether a hormone called xenin-25 can restore the     activity of GIP in persons with T2DM.   "
224636|NCT00798941|"     The purpose of this study is to evaluate family-led interventions for Intensive Care Unit     (ICU) patients' symptoms (i.e., pain and thirst) that will involve ICU patients' family     members in the non-pharmacological management of these symptoms. This family involvement may     help to ameliorate not only patients' symptoms but also the families' symptoms and promote     family satisfaction with ICU care.   "
224649|NCT00799110|"     This research study is evaluating the effect (good and bad) of a dendritic cell/tumor fusion     vaccine in combination with the laboratory made agents GM-CSF and imiquimod on the     participants immune system. Another purpose of this study is to determine the type and     severity of any side effects associated with this new study vaccine. We will also be     evaluating what effect the vaccine has on the participants cancer. Dendritic cell vaccines     have already been tested in clinical trials involving participants with many different types     of cancer. Dendritic cells are powerful immune-stimulating cells that are normally found in     small amounts in the body and are responsible for immune responses against foreign     substances that enter the body.   "
224650|NCT00799123|"     The aim of the study is to evaluate urine NT-proBNP levels and new Echocardiographic Findings     in VLBW infants. The investigators hypothesize that high urine NT-proBNP concentrations are     associated with a hemodynamically significant ductus arteriosus. The investigators also     hypothesized that new echocardiographic parameters such as isovolumic relaxation time     (IVRT)is useful for the prediction of ductus intervention.   "
224698|NCT00786565|"     This study evaluates the visual performance and occurrence of posterior capsular     opacification after implantation of a new aspherical intraocular lens compared with a control     spherical lens of otherwise identical design.   "
224637|NCT00798954|"     The use of DES have not diminished the need of improved treatment strategies , especially the     treatment of bifurcation lesions still leave much to be clarified. Particularly, for     bifurcation lesions where stenting the main branch could result in an obstruction of a vital     side branch, many reports have been about using 2 drug-eluting stents. Resulting in less than     favorable, target lesion revascularization (TLR) rates, with 10-15% for main branch and     11-40% for side branch.      In Japan, the PERFECT multi-center registry evaluated outcomes of single stenting plus     kissing balloon technique after Directional Coronary Atherectomy (DCA) removal of tissue     plaques. TLR rates for both main branch and side branch were a satisfactory 1.3%. However,     the DCA technique is mainly suitable for proximal coronary artery lesions, and takes skilled     operators.      For the treatment of relatively distal bifurcation lesions, where first POBA is performed,     then the lesion is stented, followed by kissing balloon technique to fully expand the side     branch, is considered a viable treatment. The Toyohashi Heart Center outcomes from August     2004 for this single stent and kissing ballooning technique, using the sirolimus-eluting     stent on bifurcation lesions, achieved a satisfactory 5.2% TLR for both main and side     branches, suggesting that using two stents may not be necessarily the ideal treatment.      The paclitaxel-eluting stent is expected to become available in Japan from June 2007. This     stent's cells can be expanded to a maximum of 3.5mm, which should provide a larger lumen     access for side-branch treatment.      As such, we developed this study to compare the outcomes of paclitaxel-eluting and     sirolimus-eluting stents in bifurcation lesions that require side branch dilatation using the     kissing ballooning technique.   "
224638|NCT00798967|"     Teduglutide is an investigative medicine being evaluated as a possible treatment for people     with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar     to a protein the body makes. When people have SBS, their bodies do not make enough of the     protein and they have trouble getting nutrients and fluids from the food they eat and drink.     This study was designed to provide evidence of efficacy, safety, and tolerability of     teduglutide 0.05 mg/kg daily in SBS subjects.   "
224639|NCT00798980|"     In this non-interventional study we investigate the nulliparous women individual evaluation     of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.   "
224642|NCT00799019|"     This multicenter, immunogenicity surveillance registry employs a prospective, cohort design     for patients who are using erythropoiesis stimulating agents (ESA)according to normal     practice consistent with the medical indications. Subjects will be observed for the     development of immunogenicity and PRCA for up to 3 years. Information on exposure to ESA     products, ESA product handling and storage, and most recent hemoglobin level will be     collected quarterly in the case report form. For cases of suspected PRCA, that sera specimen     will be tested for EPO antibodies at Division of Nephrology, Chulalongkorn University     Laboratory.      An Advisory Board (ADB) will periodically review blinded case data for subjects with     unexplained loss of efficacy (LOE), identify cases of EPO antibody-mediated PRCA and will be     responsible for data summary and make recommendations related to the incidence rate of PRCA     associated with S.C. ESA use. The registry will provide no inducement to change therapy and     will be non-interventional. The primary objective for this study is to estimate the incidence     of anti-human Erythropoiesis and anti-EPO PRCA, develop in such patients. The diagnosis of     PRCA by bone marrow biopsy must be prerequisite before the antibody assay. The secondary     objective is to evaluate the efficacy of ESA for treatment of erythropoiesis deficiency     anemia. Registry subjects will be adult men and women who are receiving or about to receive     (within 1 month) a marketed ESA product by the s.c. route of administration at the time of     enrollment. The marketed ESAs include innovative ESA and biosimilar ESA. Potential subjects     will only be enrolled if they have been receiving an Erythropoiesis product for less than 1     year. Cases of EPO antibody-mediated PRCA will be determined by the clinical presence of     essential criteria of unexplained LOE, administration of ESA product, bone marrow biopsy     diagnosis of PRCA, and presence of EPO antibody. The sera of patients who meet all criteria     will be assayed for neutralization.   "
224643|NCT00799032|"     To evaluate the short-term and mid-term safety and efficacy of the Catania coronary stent for     the treatment of up to two de novo lesions in native coronary arteries.   "
224644|NCT00799045|"     The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine     headache episodes following transcatheter ASD closure.   "
224645|NCT00799058|"     A Multi-Center, Randomized, Double-Blind, PlaceboControlled Phase 3 Safety and Effectiveness     Trial of a Vaginal Matrix Ring with Dapivirine for the Prevention of HIV-1 Infection in Women   "
224646|NCT00799071|"     The purpose of this study is to find a dose for a twice daily regimen for posaconazole (PSZ)     as prophylactic treatment in children with CGD, based on the PSZ trough level.   "
224647|NCT00799084|"     To improve the management of symptoms, patients with cancer undergoing chemotherapy will be     monitored using an automated telephone system to record the severity of 15 prevalent symptoms     for up to 8 consecutive weeks. Outcomes include; significant reduction in symptom severity     and improvement in health states.   "
224648|NCT00799097|"     Chronic rhinosinusitis (CRS) is a common health condition in the United States resulting in     more than 200,000 surgical procedures annually. The field of rhinology has had two major     advances which the investigators believe make more accurate prediction of postoperative     outcome possible thereby offering the potential of reducing the frequency of unsuccessful     surgical procedures. The first advance is the development of validated disease-specific     quality of life instruments for measuring outcome of CRS management. The major medical     societies now recognize disease-specific quality of life as the gold standard for assessing     outcomes in this disease and for the purposes of this study, the investigators define     surgical outcome as change in disease-specific quality of life (QOL). The second advance is     the better understanding of the pathological process resulting in CRS. The previous construct     defined this disease as anatomic obstruction of the sinuses and their secretions. This was     thought to be best measured by CT scan which has been the main method of attempting to select     the best candidates for surgery.      The investigators hypothesize that utilizing this new conceptual framework, the investigators     can better predict surgical outcomes. The investigators will examine several preoperative     factors and their relationship to surgical outcome. The factors to be examined include     measures of the pathophysiological components of inflammation and anatomic obstruction as     well as preoperative extent of disease as measured by preoperative disease-specific quality     of life. The investigators hypothesize that these factors provide complimentary information     that may be variably expressed in individual CRS patients. Therefore, the investigators     hypothesize that a novel integration of multiple preoperative factors will form a useful     predictive model of surgical outcome. Finally this prospective study provides the opportunity     to add to the field by identifying potentially novel risk factors and comorbidities as well     as study secondary outcomes of sinus surgery including olfactory function and general health     related quality of life in a systematic manner.   "
224681|NCT00786344|"     The purpose of this study is to learn how activity promotes health and well being among older     adults. There are two main study goals: (1) to extend the previous results obtained for the     Well Elderly Study 1; and (2) to determine what factors make the program successful.   "
224651|NCT00799136|"     No standard regimen currently exists for the treatment of AIDS-related lymphoma. Based on the     encouraging NCI results with DA-EPOCH, the US AIDS Malignancy Consortium is currently     administering a phase II randomized protocol comparing EPOCH with sequential versus     concurrent rituximab (AMC protocol 034). In this AMC trial, the decision to co-administer     cART is left to the discretion of the treating physician and the patient. While the AMC phase     II study may establish an acceptable chemotherapy regimen suitable for further study in a     phase III randomized trial, the results will not address adherence, pharmacokinetic     interactions or the role of cART in AIDS-related lymphoma. The contribution of cART to the     anti-lymphoma efficacy of any regimen needs to be formally studied. Our proposed trial to     demonstrate the feasibility of co-administering cART with chemotherapy would justify the use     of combined therapy in future AMC/International phase III protocols.   "
224652|NCT00799149|"     To determine that when administered as part of a multimodal analgesic regimen, use of the new     COX-2 antagonist etoricoxib (120 mg/day, per os) is more effective in improving postoperative     pain management after knee arthroscopy than gabapentin (1.2 g/day, per os).   "
224653|NCT00799162|"     The purpose of this study is to determine if dynamic psychophysical testing along with     genetic screening will allow to identify pre-operatively women who will suffer severe acute     pain post-operatively and the subset who may experience chronic pain following cesarean     section.   "
224654|NCT00799175|"     The primary aim of this study is to evaluate if intra- and postoperative administration of     ropivacaine, ketorolac and epinephrine into the operating field would affect morphine     consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an     attempt to assess the safety of this technique, knee function and patient satisfaction scores     are assessed up to 3 months after surgery.   "
224655|NCT00799188|"     Heart transplant is a recognized therapeutic strategy in refractory heart failure. Its     success is however hampered by severe cancer occurrence and recurrence. The new m-tor     inhibiting drugs Sirolimus and Everolimus have shown potential for reducing the incidence of     cancer in animal models. They are potent immunosuppressant, antiproliferative and     antiangiogenic drugs. This open labelled randomized multicenter study aims at evaluating the     beneficial antineoplastic effect of Everolimus in 159 heart transplant patients suffering of     recurrent skin cancer. Primary objective is to demonstrate a reduction in the number of new     skin cancers. Secondary end point will be time of recurrence, incidence of non skin cancer,     graft function following switch (including death), renal function evolution following     calcineurin inhibitors reduction or withdrawal, Everolimus tolerance profile, schemes of     calcineurin inhibitors reduction management in centers.   "
224657|NCT00799214|"     Bacterial vaginosis (BV), the world's most common vaginal infection, continues to cost     patients time, energy, comfort and money. BV is associated with increased incidence of     sexually transmitted infections (including HIV), spontaneous abortion, pre-term labour,     post-surgical infections, and endometritis. Current treatment for those women symptomatic for     BV includes both oral and intravaginal antibiotics, such as metronidazole, which have success     rates of 70-80 % at 1 month after treatment. These treatments also have high recurrence rates     (49-66 % at one year after treatment) and side effects (10-20 % of women) that include     secondary vaginal infection with candida. Intravaginal boric acid has been used for >100     years for the treatment of vaginal infections and is quite commonly prescribed today as a     treatment for BV. It is cheap, easily accessible, easy to use, and is an effective treatment     of other vaginal infections, such as candida. To date, there are no clinical trials studying     the effectiveness of boric acid in the treatment of BV.      The objective of this study was to determine whether intravaginal BA is comparable to     standard treatment, metronidazole, for the cure of BV in symptomatic women.      Our research question is: Among women 16-50 years old symptomatic with BV is intravaginal     treatment with BA non-inferior to metronidazole to achieve a Nugent score <7 (cure) by day     17.      Hypothesis: H0: BA proportion of women cured < metronidazole proportion of women cured - 10%.   "
224658|NCT00799227|"     The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in     the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be     followed for 26 weeks.   "
224659|NCT00799240|"     This study will compare the rate of chemotherapy: pemetrexed and cisplatin compared with the     combination of pemetrexed/cisplatin with MK-0646. The other purposes are to determine how     long we can control the cancer growth and toxicity and safety of the combination. Laboratory     research with the tumor tissue and blood obtained will be done to assess IGF-1R expression     and related markers and correlate with response and survival.   "
224660|NCT00799266|"     This study is designed to evaluate the efficacy and safety of zoledronic acid compared to     placebo in osteoporotic children and adolescents treated with glucocorticoids   "
224661|NCT00799279|"     The aim of this study is to determine if providing smokers identified in family doctors     offices with follow-up counselling enhances their success with quitting and the number of     health professionals helping patients with quitting. Six to eight family medicine clinics     will be involved in the study. We will compare the frequency of addressing smoking with     patients and the proportion of smokers who are successful with quitting 16-weeks following     the clinic appointment between practices. It is hypothesized that the addition of follow-up     counseling to a multi-component smoking cessation intervention will improve smoking outcomes.   "
224682|NCT00786357|"     The purpose of this study is to determine if a modified version of the Sleep Enhancement     Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and     quality of life in experienced shift-working nurses.   "
224683|NCT00786370|"     The use of dexmedetomidine in cataract surgery is still limited and to date only one study     has examined anesthetic technique in this patient population. This pilot study will therefore     compare the use of dexmedetomidine and propofol in subjects undergoing cataract surgery. The     primary endpoint will be based on simple cardiorespiratory measures often associated with     complications from sedation as well as assessment of the achieved sedation by the attending     anesthesiologist and surgeon.   "
224662|NCT00799292|"     Vasoconstrictive agents are increasingly being used in order to decrease blood loss during     vaginal hysterectomy. The first reported study of the use of a vasoconstrictive agent for     this purpose was on the use of epinephrine injected intracervically preoperatively by     England, et. al. They demonstrated a significant decrease in the amount of blood lost during     the surgery but also demonstrated a significant increase in the risk of post-operative     infections, most frequently a vaginal cuff cellulitis requiring antibiotic treatment. Recent     studies using vasopressin as the vasoconstrictive agent have also found the same significant     decrease in blood loss while not demonstrating a difference in the rate of post-operative     infections. The more recent studies by Speer and Unger , and Kammerer-Doak, et.al. were     larger, better designed studies and are considered more credible. More surgeons are therefore     injecting vasopressin intracervically preoperatively.      Some surgeons believe that the injection of vasopressin intracervically prior to the initial     incision of a vaginal hysterectomy effects surgical plains and therefore makes the surgical     dissection more difficult. This is thought to possibly both add to operative time and     increase the rate of complications. The aforementioned studies used the injection of saline     as a control for the injection of vasopressin or epinephrine. To date, no study has compared     the use of vasopressin versus no injection in a controlled, randomized manner. We do not know     if the injection of saline intracervically may actually increase the amount of bleeding over     the baseline and therefore the decreased blood loss caused by the injection of vasopressin my     actually be overestimated.      We propose to compare the effects of injecting vasopressin intracervically preoperatively     versus no preoperative medication. We will not only evaluate the amount of operative blood     loss, but also compare operative time and complication rates.   "
224663|NCT00799305|"     The aim of the study is to assess the correlation between airflow limitation, perception of     dyspnea and functional capacity with anatomic changes in pulmonary structure as seen on High     Resolution CT in COPD patients.   "
224664|NCT00799331|"     The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses     of AZD5985 in healthy male volunteers   "
224665|NCT00799344|"     To address early vessel healing and thrombus formation after deployment of three distinct     groups of stents   "
224666|NCT00799357|"     A variety of pre-intubation clinical screening tests have been advocated to predict difficult     laryngoscopy, but their usefulness is limited in emergency department, intensive care unit,     pre-hospital and combat settings. Patients in these settings are often confused, lethargic,     obtunded, uncooperative and common screening tests for difficult laryngoscopy cannot be     applied in a large number of emergency intubations. In the recent past, there has been     growing interest in upper airway ultrasound. The purpose of this study is to assess the     utility of bedside ultrasound to predict difficult airway in patients requiring emergency     intubation.   "
224667|NCT00799370|"     The study analyzes the consequences of weight bearing after an HTO in a population of young     patient with medial osteoarthritis (immediate weight bearing versus two month weight     bearing). The two options are usually used so the protocol belongs to the intermediate care     evaluation category.      The IKS (International Knee Society) score at one year follow up is the first outcome. The     aim of the study is to highlight that the option early weight bearing (immediately in     postoperative) is equal to the option delayed weight bearing.   "
224668|NCT00799383|"     The purpose of this study is to determine whether calcium and vitamin D supplementation, over     a nine-month period, optimizes bone mineralization in boys with risperidone-induced     hyperprolactinemia. We hypothesize that, by the end of the stuy, children in the     supplementation group will have higher bone mineral density compared to those in the placebo     group.   "
224669|NCT00799396|"     One of the most common ways for preventing coronary heart disease (CHD) is to take aspirin or     clopidogrel. However, studies have shown that not all people respond to these medications.     The variance in treatment response may be linked to genetics. This study will examine the     effects of aspirin and clopidogrel in a population whose genes are well known in order to     determine the role that genes play in treatment responses.   "
224670|NCT00799409|"     The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate     HCl), is safe and effective in improving academic performance and behavior in children with     attention deficit hyperactivity disorder (ADHD), when compared to placebo.   "
224671|NCT00799422|"     The purpose of this study was to investigate contact lens fit, lens parameters, and     conjunctival staining in a sample of subjects with various contact lens/solution     combinations.   "
224672|NCT00799435|"     People with type 2 diabetes experience heart failure more often than do people without     diabetes. This may be due to increased stiffness in the heart as a result of diabetes. This     study will examine whether exenatide, a medication used to treat diabetes, may have     beneficial effects on the heart in people with type 2 diabetes and heart failure.   "
224673|NCT00799448|"     This trial is conducted in Europe. The aim of this trial is to compare the efficacy and     safety of repaglinide combined with insulin NPH versus biphasic human insulin 30 alone in     type 2 diabetics inadequately controlled with sulfonylurea (SU) +/ biguanide therapy   "
224674|NCT00799461|"     RATIONALE: A personalized Internet-based program may help improve fatigue, depression, and     quality of life in long-term survivors of stem cell transplant. It is not yet known whether     an Internet-based program is more effective with or without telephone-based problem-solving     training.      PURPOSE: This randomized clinical trial is studying how well an Internet-based program works     with or without telephone-based problem-solving training in helping long-term survivors of     hematopoietic stem cell transplant cope with late complications   "
224675|NCT00799474|"     This research focuses on men who have sex with men (MSM) who are at higher risk of anal     cancer. The survey will evaluate their beliefs about anal and oral cancer, their knowledge     about role of human papillomavirus (HPV) infection in these cancers, and their knowledge of     HPV vaccination and anal Pap smears. Approximately 12% of subjects will be HIV-positive.   "
224676|NCT00799487|"     The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate     HCl), is safe and effective in improving academic performance and behavior in children with     Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.   "
224677|NCT00799500|"     Interventional study to assess the effect of early detection and treatment of bacterial     vaginosis in pregnancy on preterm delivery rate.   "
224678|NCT00799513|"     This phase II multi-institutional trial will explore the safety and efficacy of lenalidomide     monotherapy given as maintenance therapy following salvage chemo-immunotherapy in patients     with relapsed or refractory chemosensitive diffuse large B-cell lymphoma   "
224679|NCT00799526|"     The purpose of this study is to investigate the safety and efficacy of human conjunctival     epithelial autologous cultivated ex vivo for reconstruction of the ocular surface in patients     with symblepharon.   "
224680|NCT00786331|"     The aim of this study is to compare time to progression between the combination     pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally     advanced or metastatic NSCLC.   "
224684|NCT00786383|"     We are conducting a research study for tumors that have not responded to prior treatment. The     subject will receive an investigational drug called IMC-1121B. ImClone LLC, the maker of     IMC-1121B, is running this research study.      We believe that IMC-1121B blocks the growth factors made by the cancer cells, so new blood     vessels do not grow. It is believed that without the new blood vessels, the cancer or tumor     will not get the oxygen and food that it needs to grow. This may stop the cancer from growing     or spreading and the tumor cells may die. Since normal blood vessels have already formed in     adults, it might be possible to stop tumor growth without harming normal cells.   "
224685|NCT00786396|"     The aim of this study is to develop effective interventions for HIV-infected prisoners who     are released to the community. The intervention that we will study will be directly observed     therapy (DAART/DOT) and we will compare this to the current standard of care that involves     self-administered therapy (SAT). All subjects will get transitional case management and all     subjects with a prior history of opiate dependence will be offered opiate substitution     therapy (buprenorphine or methadone).      Hypotheses:        -  At the end of six months those receiving DAART will have a higher level of adherence to          HAART as compared to the SAT group.        -  The DAART Intervention will result in subjects having lower viral loads and higher CD4          counts as compared to the SAT group.        -  At the end of six months, the DAART group will have a lower rate of recidivism to          jail/prison as compared to the SAT group.        -  Over the year, the DAART group will be more likely to make repeated primary HIV care          visits than the SAT group.   "
224686|NCT00786409|"     The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine     Gardasil in young women.   "
224687|NCT00786422|"     This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in     patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who     concomitantly use a strong cytochrome P450 isoenzyme 3A4 (CYP 3A4) inducer for the entire     3-month study duration.   "
224711|NCT00786734|"     Patients who is scheduled elective PCI are randomized to pitavastatin 4mg daily or without     pitavastatin for 5 -7days before the procedure. Creatine kinase-MB, troponin I, and myoglobin     levels are measured at baseline and at 8 and 24 hours after the procedure(1st evaluation).     After PCI, pitavastatin will be administered for additional 4 weeks(2nd evaluation).   "
224712|NCT00786747|"     The study investigators have developed an interactive multimedia computer program that     provides personally tailored education about colorectal cancer screening in the user's     preferred language (English or Spanish). In this study, the investigators will examine     whether use of the computer program increases the number of Hispanic patients who receive     colorectal cancer screening and lessens or eliminates the glaring disparity in screening     between Hispanics and non-Hispanic whites.   "
236235|NCT00949143|"     The aim of this study is to investigate the effects of altering the wheelchair set-up on     mobility and safety by changing the rear-axle position on a manual wheelchair.   "
224688|NCT00786435|"     As people with spinal cord injuries (SCI) get older they become more likely to develop health     problems, just like everyone else. However, SCI increases the risk of certain problems. This     research project will focus on the control of blood sugar after SCI. Sugar in the blood is     the important source of energy for the body. Too much sugar in the blood is known as     hyperglycemia and not enough sugar in the blood is known as hypoglycemia. Under healthy     conditions, the amount of sugar in the blood is automatically regulated so that a steady     level is maintained. After SCI, however, this automatic regulation is damaged. The likelihood     of experiencing too much or too little blood sugar is increased. Over time, having too much     blood sugar can lead to the development of diabetes. In just the opposite situation,     individuals with SCI can begin to experience more frequent episodes of too little blood     sugar. It is thought that the level of SCI, amount of time post-injury, and amount of body     fat are important factors in the development of hyperglycemia or hypoglycemia. This study     will test 2 of those factors, level of SCI and amount of body fat. A total of 35 subjects     will be enrolled, 24 with SCI and 11 able-bodied controls. All procedures will be performed     at the university's clinical research center. Susceptibility to hyperglycemia will be tested     by having each subject drink a sugar water solution and then taking blood samples every 30     minutes for 2 hours. Hypoglycemia will be tested by very carefully inducing low blood sugar,     taking blood samples over a 2 hour time period to evaluate different chemicals, and answering     a questionnaire about different symptoms experienced during the procedure. Body fat will be     measured by having a special kind of x-ray. It is predicted that subjects with cervical     injuries and with more body fat will be at the greatest risk of experiencing hyperglycemia     and hypoglycemia. The results from this study will provide important information for future     studies aimed at examining the effect of exercise and other potentially therapeutic agents on     blood sugar regulation in the aging SCI population.   "
224689|NCT00786448|"     - Data are obtained of Emselex in routine treatment of Overactive Bladder. The general     objectives are to evaluate the product safety, compatibility, efficacy and patient     acceptance.   "
224690|NCT00786461|"     Silver nitrate treatment of Bartholin's cyst or abscess will be compared to marsupialization     treatment.      It is expected that silver nitrate treatment is effective, simple, inexpensive and the least     anaesthetic requiring procedure, which can easily be carried out in the outpatient setting.   "
224691|NCT00786474|"     Blood thinners, such as warfarin, prevent blood clots from forming, thereby reducing the risk     of a stroke or heart attack. When people undergo surgery or certain procedures, they must     stop using warfarin to prevent too much bleeding during and after the surgery or procedure.     Some doctors prescribe a different blood thinner, one that works more quickly and wears off     more quickly, to bridge the gap between starting and stopping warfarin. However, this     short-term treatment is expensive, may increase the risk of bleeding, and has not been proven     effective. This study will determine whether a bridging blood thinner called dalteparin is     helpful or harmful for people with atrial fibrillation who stop taking warfarin in     preparation for surgery or a procedure.   "
224692|NCT00786487|"     We are interested in how skeletal muscle processes fat and how this may affect insulin     resistance. This is an important question since insulin resistance predates and predicts type     2 diabetes. We know that if pharmaceutical grade fat is infused into people, they develop     insulin resistance. Likewise, we would like to infuse pharmaceutical grade fat into trained     subjects, believing that trained subjects will have less insulin resistance, less decline in     muscle energy function, and less accumulation of fat metabolites than untrained subjects. For     comparing the effects of the pharmaceutical grade fat infusion, we will also have a group of     trained and untrained subjects given a control (glycerol) infusion. Glycerol is basically the     same as pharmaceutical grade fat infusion without the fat component.   "
224693|NCT00786500|"     The aim of the present study was to investigate the long-term effects on blood glucose     concentrations and possible adverse effects of an extract of Gynostemma pentaphyllum (GP).     This is a plant growing in the mountain regions of Northern Vietnam and previously being used     in traditional medicine. The GP extract, or placebo, was randomized to newly diagnosed     patients with type 2 diabetes and administered as a tea, 3 g two times daily during 12     weeks. All patients received instructions regarding diet and physical exercise. Oral glucose     tolerance tests were performed at baseline and then every 4 weeks, and blood tests were taken     with the purpose to monitor lipids, kidney and liver function, body weight and blood     pressure.   "
224694|NCT00786513|"     The purpose of this study is to determine whether choosing antibiotics based on a biofilm     antimicrobial susceptibility assay rather than a conventional planktonic antimicrobial     susceptibility assay to treat CF patients with chronic P. aeruginosa infection with an acute     pulmonary exacerbation is a safe intervention that will result in improved microbiological     and clinical outcomes and decrease markers of pulmonary inflammation.   "
224695|NCT00786526|"     Animal studies showed that controlled mechanical ventilation (CMV) can induce dysfunction of     the diaphragm, resulting in an early-onset and progressive decrease in diaphragmatic     force-generating capacity, called ventilator-induced diaphragmatic dysfunction (VIDD).   "
224699|NCT00786578|"     Type 2 diabetes is a growing public health issue and one component of Type 2 diabetes is     'insulin resistance - the ability of insulin to work less well. The skeletal muscle is one     of the largest users of sugar in the body, when the skeletal muscle is insulin resistant,     this contributes to diabetes. There is some evidence that the amount of fat in the skeletal     muscle is related to the amount of insulin resistance. We are asking people to participate in     a study to look at the amount of fat in muscle and how this fat amount changes with exercise.     We hypothesize that heavier people will have higher amounts of fat and deplete this fat more     slowly than lean subjects.   "
224700|NCT00786591|"     Acute pancreatitis refers to inflammation of the pancreas and is associated with sudden onset     of severe abdominal pain, often accompanied by transient systemic manifestations, including     fever. In the majority of cases, the inflammatory process is self limiting and patient     recovers uneventfully; however, in about 20% to 30% of the cases, a protracted clinical     course ensues and the disease may progress to a severe necrotizing form, often triggering a     systemic inflammatory response syndrome during which time, acute respiratory distress     syndrome, renal failure, shock, and disseminated intravascular coagulation may occur. In the     worst sequelae, multiple organ dysfunctions may follow and death supervene. The clinical     outcome of patients suffering from severe acute pancreatitis depends to a great extent on the     early diagnosis and prediction of severity and timely therapeutic intervention to prevent     local and systemic complications. However, the course of the disease is often difficult to     predict from the outset. Currently, there is still no single clinical or laboratory test that     can be considered the gold standard for diagnosis and/or assessment of severity of acute     pancreatitis. For a disease that may progress rapidly without apparent sign, the ideal marker     for the prediction of disease severity in a patient would be one that is measurable rapidly     and easily, besides being able to fulfill all the other criteria required of a good     biological marker. To identify such a potential marker for acute pancreatitis requires     understanding of the pathophysiological process underlying the rapid progression of a     fulminant course of the disease. Although much remains to be elucidated, recent studies in     animals have suggested that inflammatory mediators substance P and hydrogen sulfide may play     critical roles. This study will evaluate if inflammatory mediators substance P and hydrogen     sulfide are upregulated early on in the disease process, and if the levels of their elevation     predict disease severity.   "
225297|NCT00801320|"     The purpose of this research study is to collect tumor samples at the time of surgery and     store them for possible use as part of an experimental vaccine study for the participants     cancer in the future.   "
224701|NCT00786604|"     The purpose of this research study is to find out how blood sugar levels change during the     day and night in people living with spinal cord injuries (SCI) and then to compare that with     people who do not have a spinal cord injury.      As people with SCI get older they become more likely to develop health problems, just like     everyone else. However, SCI increases the risk of certain problems. The amount of time     post-SCI can also increase the risk of certain problems. This research project will focus on     identifying the patterns of changes in blood sugar levels after SCI. Sugar in the blood is     the important source of energy for the body. Too much sugar in the blood is known as     hyperglycemia and not enough sugar in the blood is known as hypoglycemia. Under healthy     conditions, the amount of sugar in the blood is automatically regulated so that a steady     level is maintained. After SCI, however, this automatic regulation is damaged. The likelihood     of experiencing too much or too little blood sugar is increased. Over time, having too much     blood sugar can lead to the development of diabetes. In just the opposite situation,     individuals with SCI can begin to experience more frequent episodes of too little blood     sugar, which can lead to acute emergency situations.      The pattern of how blood sugar levels change during a typical 24-hour time period in persons     with SCI is not known. There may be unknown factors that affect blood sugar levels. In order     to find out that information, this study will involve continuously monitoring blood sugar     over a 3-day period in a variety of persons with SCI. A non-invasive, wireless monitoring     system will be attached to the abdomen. This system records blood sugar levels every 5     minutes. The information gathered from this observational study is vital to the understanding     of how SCI alters the regulation of sugar levels in the blood and to the subsequent medical     management of this population.   "
224702|NCT00786617|"     1. Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol will          have a mean length of stay on ventilator at least one day shorter than patients weaned          by physician-initiated, non-protocol methods        2. Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol will          have al least similar Ventilator, ICU, and Hospital Length Of Stay (LOS) compared to          patients weaned by physician-initiated, non-protocol method        3. Nurse-driven ventilator weaning protocol is well accepted by other services: physicians,          nurses, and respiratory therapists.   "
224703|NCT00786630|"     This is a five-year prospective randomized trial comparing two intervention conditions     designed to facilitate substance abuse treatment entry and enhance retention in order to     reduce the behaviors associated with HIV and HCV risk among injection drug users (IDUs) and     to improve client overall functioning. The overall goal of this project is to compare     strengths-based case-management (CM) to an enhanced version of CM that uses case managers to     facilitate a therapeutic alliance (CM/FTA) among out-of-treatment IDUs in Denver.   "
224704|NCT00786643|"     The purpose of this study is to evalute the response and toxicity of metastatic colorectal     cancer patients to the regimen of gamma interferon added to bolus and infusional     5-fluorouracil and leucovorin (GFL) with or without bevacizumab.   "
224705|NCT00786656|"     Background:        -  Studies suggest that cancer patients diagnosed and treated in a facility with          multi-specialty care and clinical research may live longer and have a better quality of          life than patients treated elsewhere.        -  The NCI Community Cancer Centers Pilot Program (NCCCP) is a 3-year program to test the          concept of a national network of community cancer centers to expand cancer research and          deliver the most advanced cancer care to Americans in their own communities.        -  The pilot program includes a survey of cancer patients receiving care at the pilot          sites.      Objectives:        -  To gain an understanding of the experiences of adult patients who receive services at          the NCCCP pilot sites and assess if and how their experience changes over the study          period. Data about the following are collected:        -  Patients information needs and awareness of the NCCCP program        -  Clinical trials experience        -  Access to health care        -  Perspectives on patient-provider communication        -  Experiences with patient navigation, self-management, medical decision-making and          survivorship        -  Satisfaction with care and quality of life      Eligibility:        -  Patients 21 years or older at the time of diagnosis        -  Treatment at the cancer center for at least 3 months since July 1, 2007      Design:        -  Participants complete a 25-minute questionnaire covering the care they received at their          cancer center, their experience with making medical appointments and how long they          waited to see the doctor. The survey includes information on the following:        -  Services at the cancer center        -  Getting needed care        -  Assistance for patients and their families        -  Communication with the cancer care team        -  Clinical trials        -  Care after finishing treatment        -  Evaluation of care        -  Health and medical history        -  Background information (demographics)   "
224706|NCT00786669|"     The purpose of this research study is to test the safety and of adding bevacizumab to the     established regimen of vincristine, oral irinotecan, and temozolomide (VOIT) and see what     effects it has in pediatric patients with relapsed or refractory solid tumors.   "
224707|NCT00786682|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Hydroxychloroquine may help docetaxel work better and kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving docetaxel together with     hydroxychloroquine works in treating patients with metastatic prostate cancer.   "
224731|NCT00787007|"     The purpose of this study is 1) to test the safety of S-equol in healthy volunteers and 2) to     see how quickly S-equol enters the bloodstream, is distributed in the body, and broken down     and removed, when taken with food or without food.   "
224836|NCT00788541|"     The purpose of this study was to assess the effects of total volume and total dose on the     safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and     48 mg) in 0.5 mL and 0.8 mL volumes when administered by anterior juxtascleral depot (AJD)     for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma     or ocular hypertension.   "
224708|NCT00786695|"     Gastroesophageal reflux disease (GERD), with its cardinal symptom, heartburn, is the most     common disorder of the esophagus in the West. Comparatively, GERD is less common in Singapore     but its frequency in the population is increasing. Although the vast majority of patients     with GERD have heartburn and acid regurgitation, GERD can present in atypical ways, including     as a non-cardiac chest pain (NCCP). We have previously shown that GERD is a common cause of     NCCP in Singapore. Up to 40% of our patients with NCCP had endoscopic esophagitis, abnormal     24-hour pH monitoring results, and/or a positive acid perfusion test. These tests, although     diagnostic, are costly, labour intensive, and not always readily available in the primary     care setting. A trial of high-dose proton pump inhibitor (e.g. omeprazole 60 mg daily) has     been proposed as a simple, safe, non-invasive and reliable means to diagnose GERD in Western     patients with NCCP. We have not used the test routinely in our practice. This study will     evaluate the use of a short course of esomeprazole, the S-isomer of omeprazole, as a     diagnostic test for detecting GERD in patients with NCCP. The hypothesis is that in NCCP     patients with GERD, esomeprazole will resolve their symptoms. Consecutive patients diagnosed     with NCCP at the National University Hospital, Singapore, will be invited to participate in     the study. Eligible patients will be randomly assigned to receive either esomeprazole (40 mg     o d) for 14 days, or comparable dose of placebo at a similar schedule for 14 days, in a     double-blinded fashion. At the start of the study, all subjects will complete a baseline     symptom assessment. Symptoms will be scored on a graded scale based on severity. During the     study weeks, each patient will record his/her own daily symptoms. The patient will be     assessed again after the 14-day treatment. The primary outcome measure will be the change in     symptom score after initiation of treatment.   "
224709|NCT00786708|"     Hypothesis: In patients that present to an urban emergency room, a single urine neutrophil     gelatinase-associated lipocalin (NGAL) measurement can classify their kidney disease as     stable chronic kidney disease, acute tubular necrosis, urinary outlet obstruction or     pre-renal azotemia.   "
224710|NCT00786721|"     There has been increasing support for our hypothesis that mitochondrial dysfunction plays an     important role in the etiology of Type 2 Diabetes Mellitus and the overlapping Metabolic     Syndrome.   "
224713|NCT00786760|"     The purpose of this study is to learn about the natural history of Human Papillomavirus (HPV)     infection in men. The study will also find out what factors are linked to HPV in men     including other sexually transmitted diseases (STDs). If participants test positive for     syphilis, gonorrhea or chlamydia, we are required by law to report the results to the Florida     Department of Health. Participants will be able to get free medical treatment from the     Florida Department of Health for these STDs. Participants will be given a written report of     the results of the STD testing.   "
224714|NCT00786773|"     To describe the change of impact of reflux symptoms on the everyday life perceived by     patients before and after 4 weeks treatment by using GERD Impact Scale questionnaire (GIS) by     total GERD patient population and by treatment group; and to describe the concordance between     patient-reported and physician-reported symptom load.   "
224715|NCT00786786|"     Purpose: This project is designed to identify what the key barriers to participating in     exercise are for the general population of people living with spinal cord injury (SCI) in the     United States (US).   "
224716|NCT00786799|"     Omega-3 fatty acids are among the most commonly used CAM (Complementary Alternative Medical)     therapies, and have been reported to be currently used by 28.7% of children with autism. Two     published case series noted that families reported large improvements in the core feature of     autism when children were given omega-3 fatty acids. Low levels of omega-3 fatty acids have     been noted in children with autism, which suggests normalizing the omega-3 fatty acid levels     could produce improvements in the symptoms seen in many children with autism.      This study is a 12-week randomized, double blind, placebo-controlled clinical trial for 24     male and female children aged 3 to 8 years with autism. Patients who are currently using     omega-3 would need to discontinue omega-3 fatty acids for 8 weeks before they are able to     participate in the study. All study participants who meet all inclusion and no exclusion     criteria at the initial screening visit and sign the consent form will then complete baseline     assessments of the outcome measures (validated instruments of hyperactivity, communication,     social interaction, and behavior) and be randomly assigned to 12 weeks of omega-3 fatty acids     at a dose of 1 gm per day or an identical placebo. The child's behavior will be measured and     evaluated at the MIND Institute at the beginning of the study and at study closing. All study     families will come in for a follow-up visit at weeks 4 and 8 to assess medication compliance     and side effects to study medication.      After 12 weeks of treatment, all outcome measures including laboratory tests and side effect     profiles will be repeated. All patients who complete the study will receive a 12-week supply     of omega-3. This would also provide patients who were on placebo with active medication. No     follow-up visits are needed once the patient finishes the double-blind portion of the study.   "
224717|NCT00786812|"     Maintain and monitor long-term hematological and cytogenetic responses previously obtained by     patients participating in the [CAMN107A2109] study   "
224718|NCT00786825|"     The long-range goal of this project is to determine the effects of diabetes and the     hypoglycemic consequences of intensive therapy on in vivo brain glucose metabolism in humans.     We will measure brain glycogen turnover and content in normal controls and subjects with     diabetes under conditions of modest hyper-and hypoglycemia.   "
224719|NCT00786838|"     The purpose of this study is to assess the potential effects of trabectedin on the QT/QTc     interval duration measured by electrocardiograms (ECGs) in participants with advanced solid     tumor malignancies when administered at a therapeutic dose.   "
224720|NCT00786851|"     This is a prospective, multicenter phase II trial designed to evaluate the safety and     activity of the combination of Lenalidomide (Len) and Dexamethasone (Dex) in patients with     relapsed/refractory mantle cell lymphoma (MCL).   "
224721|NCT00786864|"     This study aimed to determine the efficacy of an eight-week specific exercise programme in     reducing self-reported episodes and intensity of LBP, as well as modifying some of the     identified risk factors for LBP, in children.   "
224732|NCT00787020|"     The purpose of this study is explore how cerebrospinal fluid (CSF) drainage impacts outcomes     for patients diagnosed with subarachnoid hemorrhage (SAH). This is a non-randomized     observational study of two physician-prescribed approaches to managing intracranial pressure     monitoring and CSF drainage for SAH patients. The study will enroll only those patients who     have intracranial pressure (ICP) monitoring in situ. Because this is an observational study,     there are no physical risks to the patient, the only risk is loss of confidentiality.   "
224722|NCT00786877|"     At our field site in southern Nepal, acute respiratory illness (ARI) has been a leading cause     of mortality among young children. Besides immunization there is little evidence for     effective primary preventive approaches for ARI on a population basis. Low birth weight is     highly prevalent in this population as well affecting approximately 30% of live born infants.     Low birth weight is a key determinant of neonatal mortality and has also been resistant to     cost-effective interventions in resource poor settings. Given the lack of appropriate     interventions for poor, rural areas in developing countries and the strong observational     association between open burning of biomass fuel sources and ARI in young children and low     birth weight, we have designed a community-based randomized trial to determine if reductions     in household indoor smoke exposure can reduce the incidence and duration of acute lower     respiratory infections in children <36 months of age and low birthweight among newborn     infants. Household indoor smoke reduction will be accomplished by replacing the current cook     stove in the household with a locally appropriate, inexpensive model that is more efficient     and vented to the exterior. In addition, we will assess the impact on respiratory function     and symptoms among adults in the household. The project has 2 phases. Phase 1 is a     cluster-randomized, community-based, step-wedge trial of cookstove replacement in a rural     population of southern Nepal. Households will be randomized to receive replacement of their     cook stove with an appropriately designed, efficient stove that is vented to the exterior at     different time periods during the course of the study. An initial period of surveillance for     ARI and low birth weight will establish a baseline rate for all clusters. This will be     followed by the randomized, serial replacements of cook stoves over a 12 month period.     Surveillance will continue throughout this period and for an additional 6 -18 months     depending on when the stove was replaced. Phase 2 is a individually randomized trial in a     subset of households that will receive either the improved biomass stove from phase 1 or a     LPG stove and gas. Follow-up for phase 2 will be for 12 months with the same outcomes as     phase 1. Measurement of indoor air particulate concentration will be conducted in all     households before and after stove replacement. The analysis for both phases will focus on     estimating the impact on incidence of ARI in children and low birth weight among live births     as a result of stove replacement. Approximately 4200 children 1-35 months of age will be     required to observe a minimum 10% reduction in risk of ARI with 90% power in phase 1. Given     the expected number of live births to occur in these clusters, we can detect a 50 gram     difference in birthweight with over 90% power and a type I error of 5%. Phase 2 will have     lower power (total of 1800 households).   "
224723|NCT00786890|"     Hypothesis: A high cardiovascular risk is present in subjects with pre-diabetes in Hong Kong     Chinese.      The investigators plan to assess Chinese subjects in Hong Kong who have pre-diabetes     (impaired fasting glucose, IFG; or impaired glucose tolerance, IGT) based on oral glucose     tolerance test (OGTT) on their cardiovascular risk status such as obesity, hypertension and     lipid profile.   "
224737|NCT00787098|"     The purpose of this study is to compare the effects of specific activities with and without     an early therapeutic mobility (ETM) protocol among patients who experience three or more days     of mechanical ventilation. A second purpose is to examine staff/delivery system and patient     factors that influence the initiation and progression of activity with and without an ETM     protocol. The hypothesis is that ETM protocols will result in improved patient outcomes.   "
224738|NCT00787111|"     This open-label research study will continue to monitor the safety of fluoxetine in children     after their completion of a previous double-blind placebo controlled clinical study, with     fluoxetine. The study will also look at the effect of fluoxetine on IQ (Intelligence     Quotient) over an 18 month period.   "
224724|NCT00786903|"     In critically ill patients Candida spp. are frequently isolated from respiratory tract     secretions such as endotracheal aspirates and bronchoalveolar lavages (BAL) and are most     often considered as colonizers of the respiratory tract. In contrast, pneumonia due to     infection with Candida spp. is rare and is diagnosed by histological demonstration of the     yeast in lung tissue with associated inflammation. In spite of this, preemptive antifungal     therapy based on isolation of Candida spp. from the respiratory tract is often initiated in     critically ill patients. The disadvantages of this approach include increased selective     pressure for the development of antimicrobial resistance, potential risks of adverse drug     reactions and high treatment costs. On the other hand, immediate administration of     appropriate antifungal therapy has been shown to be an important predictor of favorable     outcome for patients with invasive fungal infections. Therefore, the development of reliable     diagnostic measures for the detection of invasive pulmonary candidiasis is crucial. The     overall objective of the proposed research project is to identify diagnostic strategies to     differentiate between Candida colonization and Candida infection of the lower respiratory     tract in critically ill patients. The proposed projects intends to test the hypothesis that     1.) invasive Candida strains from the lower respiratory tract differ from colonizing Candida     strains with regard to production and expression of putative virulence factors and/or that     2.) patients suffering from pulmonary invasive candidiasis differ from patients colonized by     Candida spp. with regard to inflammatory markers, other serum markers (fungal antigen) and     composition of indigenous pulmonary bacterial flora.   "
224725|NCT00786916|"     This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the     effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term     deep sedation in children. Patients will be randomized to receive either placebo (saline) or     one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The     efficacy of the differing lidocaine doses will be compared to determine the minimum dose     required to safely achieve alleviation of pain. We hypothesize that premedicating with     lidocaine will significantly decrease pain experienced by pediatric patients receiving     propofol for outpatient sedation.   "
224726|NCT00786929|"     The purpose of this study is to evaluate if percutaneous drainage of sterile fluid     collections recurring after initial aspiration in acute pancreatitis yielded better results     than their conservative management.   "
224727|NCT00786942|"     The purpose of this study is to determine wether autologous bone graft from iliac crest     enhances bone union of tibial osteotomies, in the treatment of varus knee deformity.   "
224728|NCT00786968|"     This is a one-year extension study of the use of laronidase into the spinal fluid to treat     spinal cord compression in mucopolysaccharidosis I. Mucopolysaccharidosis I is a rare genetic     condition due to deficiency of the enzyme alpha-l-iduronidase. Spinal cord compression occurs     in this condition due to accumulation of material called glycosaminoglycans (GAG). Laronidase     is the manufactured form of the enzyme alpha-l-iduronidase that is deficient in     mucopolysaccharidosis I patients. The aim of this study is to determine whether laronidase is     safe and effective when given into the spinal fluid as a potential non-surgical treatment for     spinal cord compression due to mucopolysaccharidosis I disease. Funding Source -- FDA OOPD   "
224729|NCT00786981|"     Lumbar spinal stenosis (LSS) is a prevalent and disabling condition in the rapidly growing     aging population. People with LSS often have a substantial physical and psychosocial burden     as well as significant healthcare costs affecting both the individual and society. It has     been reported that patients with LSS over the age of 65 are more likely to undergo spinal     surgery than any other condition with an estimated total annual inpatient expense of one     billion. Individuals undergoing surgical treatment for LSS tend to be older, therefore     operative morbidity and mortality are a particular concern. Functional benefit derived from     conservative treatment may increase the health and quality of life for individuals suffering     from LSS and avoid or delay the need for surgery in some subjects. As the population     continues to age, identifying effective non-surgical treatment options for older patients     with LSS is an important research priority. Ultimately, the information gained from this     study will help fill a significant void in medical literature regarding non-surgical options     for this patient population.   "
224730|NCT00786994|"     In this study the impact of Oleogel-S-10 versus placebo on actinic keratoses over a treatment     period of 3 months will be tested. Additionally, once and twice daily applications are     tested.   "
224733|NCT00787033|"     Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase     (FAK) inhibitor PF-04554878 in patients with advanced non-hematologic malignancies, including     patients with malignancies appropriate for serial biopsy. Screening consists of medical     history, physical examination ECOG performance status, blood draws, a pregnancy test for     female patients of childbearing potential, a FDG-PET and tumor imaging. Treatment consists of     PF-04554878 pills continued until progression of disease, unacceptable toxicity, or patient     request. Evaluations for bioactivity are measured by serial FDG-PET and blood tests for     biomarkers related to FAK and Pyk2 activities.   "
224734|NCT00787059|"     This research study is designed to determine: 1) whether gene transfer using an agent called     Ad5.hAC6 (adenovirus-5 encoding human adenylyl cyclase type 6) can be given safely to     patients with congestive heart failure (CHF) and 2) whether this agent may be of benefit in     heart failure. Gene transfer is a process by which genes are introduced into cells and the     cells then produce the specific protein that the gene directs, in this case, a protein known     as adenylyl cyclase type 6 (AC6). The gene is carried into the heart cells by a modified     virus. The virus that is modified is an adenovirus (Ad5), a virus that sometimes causes a     brief cold. In extensive animal experiments, it was found that increased amounts of AC6     protein in heart cells appeared to make the heart pump more vigorously.   "
224735|NCT00787072|"     The aim of this study is to assess the safety, tolerability and pharmacokinetics of single     ascending oral doses of AZD8075 in healthy male volunteers   "
224736|NCT00787085|"     This investigation is a epidemiologic case-control study of the risk factors associated with     nosocomial funguria (fungi in the urine).   "
224800|NCT00788008|"     The purpose of this research is to determine if post-operative cognition will be better if     the general anesthesia for surgery is done with an inhaled (gas through a breathing tube) or     intravenous (medicine injected in the IV) general anesthetic technique.   "
224739|NCT00787124|"     The purpose of this study is to better understand S-nitrosohemeglobin (SNO-Hb) in transfused     blood of extremely preterm infants. The long term goal of the project is to identify     variation in the SNO-Hb between packed red blood cell units, and between and among individual     preterm infants pre and post-transfusion. Duke investigators are developing methods to     replenish SNO-Hb, which, if successful, would improve RBC deformation in addition to     providing a vasodilatory stimulation to hypoxic tissue, and lead to a randomized clinical     trial testing treated vs. untreated RBC transfusions in extremely premature infants.      AIM 1. Measure the Total Hemoglobin (Hb)-bound nitric oxide (NO), Hb [Fe] NO, SNO-Hb (a     calculated value = (total Hb-NO - Hb [Fe] NO) in blood to be transfused in extremely preterm     babies, and in samples pre and post- transfusion from the babies.      Hypothesis 1: Measures of NO and SNO-Hb will be low in blood used for transfusion in preterm     infants and will be decreased in the post-transfusion samples from the infants compared with     the pre-transfusion samples.      AIM 2. Collect clinical data about study participants, including oxygen saturation and     measures of perfusion pre and post-transfusion.      Hypothesis 2: Measures of perfusion will be reduced by 20% post-transfusion in extremely     preterm infants.   "
224740|NCT00787137|"     The primary objective is to evaluate the safety and tolerability of a single intravenous dose     of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how     PG102 moves around the body and to explore its effects on the disease.   "
224741|NCT00787150|"     To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on     the composite endpoint of major and clinically relevant non-major bleeding during the     treatment period.   "
224742|NCT00787163|"     The aim of this study is to compare perinatal survival in patients presenting with early     spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with     serial amnioinfusions.   "
224743|NCT00787176|"     Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal     status. Combined-spinal epidural analgesia is a method of initiating labor analgesia used by     approximately 90% of the parturients at Prentice Women's Hospital. Optimizing the variables     which could affect fetal heart rate patterns at the time of initiation of analgesia, such as     fluid administration and oxytocin management, could help us provide better care for our     patients and their fetuses.      Hypotheses: The combination of fluid administration and lower doses of oxytocin     administration will have fewer adverse fetal heart rate changes in the first 60 minutes     following initiation of labor analgesia.   "
224744|NCT00787189|"     The purpose of this clinical study is to determine the effectiveness of low level laser light     therapy when applied around the head and ears in improving unaided word recognition in ears     with sensorineural hearing loss.   "
224745|NCT00787202|"     The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo     (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.   "
224746|NCT00787215|"     Hypothesis: There is a high rate of glucose intolerance among Hong Kong Chinese.      The investigators plan to screen Hong Kong Chinese from the community with oral glucose     tolerance test (OGTT). The subjects will be referred from GP centers in the community and     self-referred with public advertisement on this survey.   "
224769|NCT00787540|"     Chest pain, illness perception compliance and psychosocial outcome after coronary     arteriography. A comparison between patients which were diagnosed with slow coronary flow and     patients who have been diagnosed with coronary artery occlusion. We hope to prove that the     more knowledge and awareness the patient has about his disease the better his compliance and     rehabilitation.   "
224837|NCT00788554|"     The aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair     of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life,     postoperative recovery and return to daily activities, complications and recurrences   "
224747|NCT00787241|"     Thrombocytopenia (platelet count < 100,000/mL) occurs in approximately 15% of women with     preeclampsia. Neuraxial analgesia is contraindicated in parturients with a coagulopathy;     therefore, the platelet count(PC) is routinely checked prior to the initiation of neuraxial     analgesia in women with preeclampsia/eclampsia. Catheter removal is also contraindicated in     the presence of a coagulopathy. Some women have an acceptable PC at the initiation of     neuraxial analgesia, but may become significantly more thrombocytopenic during labor and     delivery. In a study of severely preeclamptic parturients, some with HELLP (H=hemolysis of     red blood cells, EL=elevated liver enzymes, LP=low platelet count) syndrome, the admission PC     correlated with the PC nadir. However, the natural progression of the PC has not been studied     in women with mild preeclampsia. We hypothesize that women with mild preeclampsia or severe     preeclampsia without HELLP syndrome, and whose admission PC is greater than 150,000/mL, will     have a stable PC during the course of labor and delivery and do not require another PC check     prior to initiation of neuraxial analgesia or removal of the epidural catheter. The purpose     of this study is to determine the positive predictive value of an initial PC greater than     150,000/mL for maintaining a PC greater than 80,000/mL during labor and delivery.   "
224748|NCT00787254|"     The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is     effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving     long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice     daily (BID).   "
224749|NCT00787267|"     On this study patients will receive dasatinib, a targeted therapy, for advanced NSCLC that     has progressed after previous therapy. Safety and response to dasatinib will be assessed.      Fresh frozen tumor tissue must be available for genomics analysis prior to initiating     dasatinib therapy. A biopsy must be obtained after any prior chemotherapy. If fresh frozen     tumor tissue is not available, a biopsy will be required to participate in this trial.   "
224750|NCT00787280|"     To evaluate whether changes in macronutrient consumption (i.e., switching to a diet low in     carbohydrates) can change brain responses to cues depicting foods representing that     macronutrient. In addition to answering specific questions regarding the effects of an LCKD,     the study will provide general information about relations between brain responses to food     cues and a broad arrive of factors including typical diet, food preferences, weight control     history and genes.   "
224751|NCT00787293|"     Improvement in heart failure with moderate to severe mitral regurgitation using a     percutaneously delivered implantable device.   "
224752|NCT00787306|"     Cardiovascular diseases remain the main cause of mortality in Canada. While effective     interventions are available for reducing the risk of cardiovascular disease,there continue to     be gaps between the potential reduction in risk that could be achieved by effectively     managing these risk factors and levels of risk factor control currently in clinical practice.     This study will evaluate the ability of a different model of risk factor care using other     health providers assisting family doctors, along with information aids for patients and     health professionals,to achieve better levels of cardiovascular risk fatror control in     adults.   "
224753|NCT00787319|"     To define what procedures were used for the diagnosis and monitoring of the treatment     age-related macular degeneration (AMD). What is the effect of the Macugen, compliance with     Macugen treatment, safety profile of Macugen, final physician assessment of treatment with     Macugen.   "
224754|NCT00787332|"     Compare Clinical Success and Costs in two Arms   "
224755|NCT00787345|"     Central line associated bloodstream infection (CL-ABI) is an important and preventable cause     of nosocomial infections and is responsible for considerable morbidity and mortality The     Centers for Disease Control have published guidelines for the prevention of CL-ABI that     represent a collaborative effort by a multidisciplinary coalition of professional     organizations that provide evidence based recommendations to prevent catheter related     infections [5]. The interventions emphasize five distinct practices, including: education and     training of healthcare providers who place and care for catheters, utilizing maximum sterile     barrier precautions during catheter placement.   "
224756|NCT00787358|"     The purpose of this research study is to test if an experimental drug called ZT-031 can help     men over 30 years or post-menopausal women over 55 years of age with certain types of hip     fracture to heal better or faster following surgery and to determine if ZT-031 is safe for     patients with fractures. To be allowed in the study you have to have a type of hip fracture     that requires surgery that is being studied (intertrochanteric fracture). You must also     otherwise be in good health, with no serious diseases such as cancer, neurologic disease,     other bone disease, liver, heart or kidney disease. You must be able to inject yourself every     day with the study medication using an injection pen, like that used for insulin injections.   "
224757|NCT00787371|"     In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver     histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma     (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore,     the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW)     PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese     patients with chronic hepatitis C.   "
224758|NCT00787384|"     The study was performed to assess: 1) clinical activity of Imatinib in patients with HES, CEL     and CIH; 2) correlation between Imatinib activity and specific disease subtype; 3) long-term     outcome of HES, CEL and CIH patients treated with Imatinib; 4) safety and tolerability of     Imatinib administration.   "
224759|NCT00787397|"     The purpose of this study is to assess whether improving sleep in children and adolescents     with anxiety disorder will further enhance affective, clinical, and social functioning.   "
224760|NCT00787410|"     This study is a multicentre, open label, non-comparative, two stage phase II trial to assess     the activity of ZD1839 (IRESSA) in patients with malignant mesothelioma. Patients will     receive trial treatment as first-line therapy, administered continuously once daily until the     completion of six 4-week cycles of treatment, disease progression, unacceptable toxicity or     withdrawal of consent. Patients continuing to show evidence of response, disease     stabilization or clinical benefit from ZD1839 may continue to receive therapy beyond     completion of the trail.   "
224925|NCT00789711|"     This study is conducted in Asia. The aim of this observational study is to compare the     clinical safety profile and effectiveness of NovoMix® 30 and Levemir™ for the treatment of     diabetes in the Philippines.   "
224761|NCT00787423|"     Background:      - Researchers are interested in developing more accurate methods to assess environmental     influences on psychological stress and drug use. One key to a more accurate assessment of     environmental influences is minimizing the delay between exposure and reporting. Portable     devices such as personal digital assistants (PDAs) and global positioning system (GPS) units     may be able to provide a more real-time image of these factors.      Objectives:      - To assess the use of PDAs to measure stress and drug use, and GPS units to assess the     effects of neighborhood environment in an outpatient treatment population.      Eligibility:        -  Individuals from 18 to 75 years of age who are current heroin users seeking treatment          for addiction and who spend most of their time in Baltimore city.        -  Participants must be able to visit the research and treatment center at least three          times per week for regular tests.      Design:        -  Participants will be in the study for approximately 28 weeks (7 months).        -  A series of three laboratory session examining responsiveness to standardized stressors          will occur both early in treatment and will be repeated late in treatment.        -  Participants will undergo 18 weeks of daily methadone maintenance. Urine samples will be          collected three times weekly.        -  To track drug use, stress, and geographical location (a measure of environmental risk),          each participant will carry a PDA and a GPS unit for 16 of the 18 weeks. Participants          will make entries (1) each time that they use a drug and (2) each time they feel          overwhelmed, anxious, or stressed more than usual. Participants will also make three          random-signal-triggered recordings per day and one brief (end of day) recording.        -  Retrospective self-report questionnaires on drug use and stress will be given regularly.        -  After 18 weeks of methadone maintenance, participants will discontinue carrying the PDA          and GPS unit and will have the choice of transferring to a community clinic or          undergoing a 10-week taper from methadone at the research clinic. Participants who stay          for the taper will continue to provide urine samples, but only once a week.   "
224772|NCT00787579|"     1. To determine if the effect of near-addition lenses (bifocals) is more prominent for          children with high myopia progression.        2. To study how different subject characteristics such as age, gender, baseline degree of          myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of          bifocal lens wear in myopic children.        3. To investigate the effect of incorporating near base-in prisms along with the          near-addition lenses (prismatic bifocals) on myopia progression in myopic children.   "
224773|NCT00787592|"     The objective of this study is to evaluate the outcomes of children with burn injury with     regard to the utilization of Silver sulfadiazine (SSD) cream and Collagenase ointment. The     primary outcome variable will be need for skin grafting. The specific aim of the study is to     prospectively collect data to determine if SSD is superior to Collagenase with regard to     avoiding the need for skin grafting.   "
224774|NCT00787605|"     The purpose of the study is to evaluate the blood pressure lowering effect and safety of     aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with     stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and <     200 mm Hg).   "
224775|NCT00787618|"     PK and safety profile of Proellex® in females with various stages of impaired renal function   "
224762|NCT00787436|"     The natural history of cirrhosis has a symptomatic and asymptomatic stage. The symptoms     include the development of ascites, hepatic encephalopathy, or variceal bleeding. The     development of portal hypertension represents a critical transition point in the natural     history of cirrhosis, contributing to, or directly responsible for all of these events. It is     defined by an increase in intrahepatic vascular resistance to portal venous inflow, with the     subsequent development of collateral vessels, such as esophageal or gastric varices. As     portal pressures rise over time, however, the resulting increase in variceal size and wall     tension translates into an increasing likelihood of rupture and bleeding, leading to death in     about 30% of patients. Over the last twenty years, data have emerged regarding the role of     tumor necrosis factor (TNFα) in portal hypertension from animal models as well as in vitro     experiments. Portal hypertension is a condition characterized by vasodilatation and a     hyperdynamic circulation, driven by relative overproduction of nitric oxide23. In animal     trials using inhibitors of TNF it has been shown to decrease the development of the     hyperdynamic circulatory state and portal pressure.24-25 Based on these data, investigators     have examined the role of TNF inhibition with thalidomide. Significant improvement in     blocking the development of the hyperdynamic circulation and portal pressures was     demonstrated.26 Human trials have also show the efficacy of thalidomide in reducing portal     pressures. In that these trials have shown promising results further investigation is   "
224763|NCT00787462|"     Idiopathic Small Fiber Neuropathy (called SFN for short), is a condition where nerves that     sense pain have become damaged, and often painful. SFN pain is common, and it can affect     sleep, memory, health and overall quality of life.      Pregabalin is a drug commonly used to treat painful conditions, like nerve pain. It has been     available to doctors for many years, and many studies have been performed to evaluate its     effectiveness. In these studies, pregabalin has been shown to be very effective in the     treatment of nerve pain, with fewer side effects than many other medications currently     available. The purpose of the study is to determine if pregabalin relieves pain more     effectively than a pill containing no medication (called a placebo). The study will also     investigate any side effects as well as the effectiveness and safety of the medication.   "
224764|NCT00787475|"     The objective of this study is to examine the effectiveness of a community health worker     intervention at helping to control diabetes among Latinos with poorly controlled Type 2     diabetes.      Hypothesis: Compared to those in Enhanced usual care group, patients randomized to the     intervention will, at 12 months, have greater reductions in: (1) HgA1C; (2) low density     lipoprotein (LDL); and (3) systolic and diastolic BP.   "
224765|NCT00787488|"     This is a pilot study aimed to test the feasibility and safety of administering combination     chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin     (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of     optimally debulked, advanced or recurrent ovarian, primary peritoneal, and fallopian tube     cancer patients.   "
224766|NCT00787501|"     Our goals are 1) to use functional magnetic resonance imaging (fMRI) to predict which     depressed individuals will respond to different validated treatments for unipolar depression     including Cognitive Therapy (CT) and antidepressant medications (selective serotonin reuptake     inhibitors; SSRIs) and 2) to understand whether CT and SSRIs affect similar aspects of brain     function underlying cognition and emotion. Thus, we will examine depressed adults ages 18-55     using fMRI during cognitive and emotional information processing tasks, before and after     treatment with an SSRI (n=25) or CT (n=40). We hypothesize that: 1) Recovery will occur in     treatment with an SSRI primarily for individuals with increased reactivity in limbic brain     regions associated with emotion generation and prefrontal regions associated with     regulation,. 2) Recovery with CT will occur for patients with increased activity in brain     regions associated with emotion generation but decreased activity in prefrontal regions     associated with emotion regulation. 3) Recovery with an SSRI will yield similar changes in     brain function to CT in brain regions associated with emotion generation but less change in     brain regions responsible for emotion regulation such as the prefrontal cortex. Findings from     this study may have a profound impact on reducing the burden of clinical depression by     providing evidenced-based diagnostic and treatment guidelines.   "
224767|NCT00787514|"     The folate receptor (FR) is a cell over expressed on the surface of certain cancers, this     occurs most frequently in ovarian cancers. Some normal tissues also express the FR, however     in these normal tissues, the FR is usually located on the tissue surface that is inaccessible     to circulating drugs. As such, drugs which target the FR may potentially be used to target     cancers which overexpress the FR while reducing toxicity to normal tissues. Therefore the     ability to measure FR levels from different cancer types may help to select patients who are     most likely to benefit from treatment with FR targeted therapies. Once such drug BGC945 is     currently being tested in preclinical study at the Institute of Cancer Research   "
224768|NCT00787527|"     The goal of this clinical research study is to find out how well the drug Zolinza     (vorinostat) works in combination with the drug combination called CHOP (cyclophosphamide,     doxorubicin, vincristine, and prednisone) to treat patients with untreated T-cell     Non-Hodgkin's Lymphoma (NHL). The safety of these drugs in combination and the best dose of     vorinostat when given in combination with CHOP will also be studied.   "
224770|NCT00787553|"     Purpose: to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the     febrile and infectious morbidity after vaginal or abdominal hysterectomy. Methods: A     randomized clinical trial carried out at the Women's Integrated Healthcare Center     (CAISM)/UNICAMP, Campinas, Brazil. Women undergoing to total vaginal or abdominal     hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis:     tinidazole, cefazolin or an association of both.   "
224771|NCT00787566|"     Brief Summary: A randomized, single administration, double-blind, parallel- group Phase 2     dose finding study to assess the efficacy, tolerability, and safety of TRG in patients with     chemotherapy-induced nausea and vomiting (CINV) associated with the administration of highly     emetogenic chemotherapy.      Primary Objective: To select a dose for Phase 3 by assessing the efficacy, safety, and     tolerability of 3 doses of TRG in patients with CINV associated with the administration of     highly emetogenic chemotherapy.   "
224799|NCT00787995|"     This multicenter, multinational, longitudinal study will quantify endurance and respiratory     function in subjects diagnosed with MPS IVA and will better characterize the spectrum of     symptoms and biochemical abnormalities in MPS IVA disease over time.   "
224776|NCT00787631|"     A high number of birch pollen-allergic individuals develop hypersensitivity reactions to     certain foods, e.g. apples. This food allergy is due to immunological cross-reactivity. Birch     pollen-related foods contain proteins, e.g. Mal d 1 in apple, that are structurally related     with the major birch pollen allergen, Bet v 1. Hence IgE antibodies and T lymphocytes     specific for Bet v 1 recognize these food proteins which results in activation of the immune     system and, consequently, in clinical symptoms.      In the present study the investigators intend to investigate if and how the consumption of     birch pollen-related food allergens affects birch pollen allergy. In other words, the     investigators are interested to analyse whether Bet v 1-related food allergens activate Bet v     1-specific memory cells and thus, contribute to the maintenance of the pollen allergy outside     the pollen season. Data obtained in this study will help to clarify the immunological and     clinical role of cross-reactivity between pollen and food allergies and will reveal whether     avoidance of such foods should be recommended for the patients. Finally, novel approaches for     diagnosis and therapy of pollen-related food allergens can be developed.   "
224777|NCT00787644|"     Asthmatics who are significantly overweight tend to have more severe symptoms, more flare     ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.      Researchers believe this occurs because excess adipose tissue (fat) in the bosy can cause     higher-than-normal levels of leptin and lower levels of adiponectin in the blood.      The researchers of this study are testing a medication called pioglitazone in overweight     asthmatics because they believe it can help regulate leptin and adiponectin and that this may     improve symptoms of asthma.   "
224778|NCT00787657|"     -  The Study analyses the influence of selected factors on adherence to Betaferon treatment          in patients with early multiple sclerosis (MS). The Investigator will document the          relevant medical data regarding multiple sclerosis at every hospital visit, the patient          will fill in two questionnaires at every visit: one about coping with the disease and          the other about anxiety and depression.        -  The Study particularly looks at the role of the support of the patient given by the          multiple sclerosis nurses.The nurse will provide additional standardised information at          start of treatment and will regularly phone the patient to ask standardised questions          about the general condition with regard to the treatment, the disease and social          support. At the end of the Study it will be assessed if the supportive measures and the          standards in terms of adherence management in the hospital have some influence to          increase long-term treatment adherence.   "
224779|NCT00787670|"     This research is a NIH single site study with the aims to (1) determine whether surgically     induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. (2)     elucidate the mechanisms by which surgically induced weight loss reduces over time the risk     of CVD in morbidly obsess subjects with T2DM.      Study'subjects will be enrolled from obese individuals with type 2 diabetes (T2DM). The study     includes two groups, subjects undergoing gastric bypass surgery and a control group not     undergoing weight loss surgery. A total of 60 subjects (30 in each group) will be recruited.      Basal, 6 and 12 months assessments will include: insulin sensitivity determination,     cardiovascular function by echo doppler, and DEXA scan.      This study involves risk-level II procedures, however, the risks inherent to the gastric     bypass surgery are not considered study-derived because subjects are enrolled from     individuals that have already decided to have this surgery. We will determine protein     expression profiles of inflammation-related adipokines in the subcutaneous and     intra-abdominal adipose tissues of morbidly obese subjects with T2DM before and after     surgically induced weight loss.   "
224780|NCT00787683|"     The purpose of this study is to investigate the cost-effectiveness and effectiveness of     remote-monitoring compared to standard care in patients with implantable cardioverter     defibrillator.   "
224792|NCT00787904|"     This is an observational study of women undergoing surgical menopause to determine whether     T-cells play an important role in the etiology of post-menopausal osteoporosis. Subjects will     examined before and after surgery and followed over a two year period to determine the     biology of T-cells during this study period.   "
224781|NCT00787696|"     This project assesses the efficacy of an HIV prevention program with adolescent females     incarcerated in the Mississippi training school for girls. Participants in both the health     education control group and the HIV prevention group will increase health knowledge as a     result of their participation in the health classes while incarcerated. However, participants     in the HIV prevention group will increase their condom application, assertiveness, and     communication skills relative to girls in the health education only group. In addition, after     release from the training school, participants in the HIV prevention group will report lower     sexual risk behaviors and will have lower rates of infection with chlamydia and gonorrhea     during the 12-month follow-up period than participants in the health education only group.   "
224782|NCT00787709|"     The proposed project takes an innovative approach to childhood obesity prevention, for which     there currently no evidence-based programs, and for which results of current trials have     produced mainly short-term or disappointing effects. The aim of this project is to adapt and     revise parts of two nationally recognized programs for drug prevention for use with children     in grades 4-6 with the express purpose of obesity prevention. The current study will attempt     to promote emotion regulation, neuro-cognitive function, and social competence in order to     prevent obesity. A total of 24 elementary schools from two of the largest districts in Orange     County will be randomly assigned to either the obesity prevention program or control group     (N=1587) 4th grade students and their parents). A cohort of students will be followed from     the 4th through 6th grades. Intervention students will be administered the Pathways obesity     prevention program by trained teachers. The population is ethnically diverse (36% white, 57%     Hispanic, 6%Asian; 48% on free/reduced lunch programs). Self-report measures, BMI, and waist     circumference will be administered at the beginning of 4th grade, and at end of 4th , 5th ,     and 6th grade. Teacher, administrative, and parent surveys will be administered on the same     schedule to measure school environment. Program implementation will be measured by teacher     self-report and research staff observations. Data will be analyzed with statistical     approaches that capture effects of school and classroom, test the theoretical model of     change, and evaluate developmental trends in mediators and outcomes across the three grades.     Findings should be generalizable to most elementary schools, and will be used to develop     evidence-based program standards for childhood obesity prevention.   "
224783|NCT00787722|"     This study is designed to examine whether treating Devic's disease patients with high dose     cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune     system), followed by return of previously collected patient's stem cells will result in     improvement in Devic's disease. Stem cells are undeveloped cells that have the capacity to     grow into mature blood cells, which normally circulate in the blood stream. The purpose of     the intense chemotherapy is to destroy the cells in patient's immune system, which may be     causing his/her disease. The purpose of the stem cell infusion is to produce a normal immune     system that will no longer attack patient's body. The purpose of study is to examine the     safety and efficacy of this treatment. The drugs used in this study treatment are drugs for     commonly used for immune suppression.   "
224784|NCT00787735|"     This research is being done to:        -  identify any emotional, behavioral or other troubling psychological problems that some          people have who are seeking and receiving treatment for heroin or other drug use          problems,        -  learn if providing additional psychiatric treatment services in the ATS drug abuse          treatment program is as beneficial for and acceptable to patients as referring them to          the Bayview Community Psychiatry Program to get help for their emotional, behavioral and          other psychological problems.   "
224785|NCT00787748|"     The prevalence of chronic obstructive pulmonary disease (COPD) in patients with     cardiovascular disease (CVD) is unknown, and whether or not COPD is adequately diagnosed and     treated in these patients has not been investigated before.      We hypothesized that the prevalence of COPD would be significantly higher (30%) in patients     with CVD than in the general population. Besides, we anticipated that COPD, a potentially     treatable CV risk factor, would be undiagnosed in more than 80% of CVD patients.   "
224786|NCT00787761|"     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop     the growth of cancer cells. It may also stop the patient's immune system from rejecting the     donor's stem cells. The donated stem cells may replace the patient's immune cells and help     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     antithymocyte globulin before the transplant and tacrolimus and methotrexate after the     transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with     cyclophosphamide, busulfan, and fludarabine works in treating patients with hematological     cancer or kidney cancer undergoing donor stem cell transplant.   "
224787|NCT00787774|"     Prospective study to evaluate the potential persistent viral effect of raltegravir in 20     treatment experienced HIV patients with incomplete viral suppression   "
224788|NCT00787787|"     This phase II trial studies how well giving sunitinib malate together with capecitabine works     in treating patients with unresectable or metastatic liver cancer. Sunitinib malate may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth and by     blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving sunitinib malate together with capecitabine may kill more tumor     cells   "
224789|NCT00787800|"     The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention     and termination therapies, minimized ventricular pacing, and remote monitoring will reduce     the rate of inappropriate shocks and improve quality of life compared to optimally programmed     back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac     death   "
224790|NCT00787878|"     The study is conducted in Europe. The primary aim of this observational study is to compare     the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin®     with untreated small for gestational age (SGA) subjects and with average for gestational age     (AGA) subjects.   "
224791|NCT00787891|"     The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the     treatment of acid-related disorders in pediatric patients, focusing specifically on the     manifestation of GERD (symptomatic and erosive types).   "
224795|NCT00787943|"     This study is a split face, paired-comparison, pilot study of 10 subjects. Participants in     this study will be patients seen at Children's Memorial Hospital, who are clinically     diagnosed with mild to moderate acne vulgaris. Participants will be recruited from the     clinic, as well as advertising and from previous Institutional Review Board (IRB) approved     acne studies housed in the Department of Dermatology. All subjects accrued from previous     studies have agreed to be contacted for further investigations. Subjects 13 to 35 years of     age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face,     and meeting inclusion criteria will be eligible to participate.   "
224796|NCT00787956|"     The Internet Chronic Disease Self-Management Program (ICDSMP) is a pilot study of our     existing, previous approved, Chronic Disease Self-Management Program Online. The online     programme will be offered to 300 people with chronic disease in South Australia and evaluated     for effectiveness, as well as satisfaction of both the South Australian peer facilitators and     the participants with chronic disease. All participants will be recruited by the State of     South Australia, after which they will complete informed consent and a questionnaire on a     secure website housed at Stanford. They will take a 6-week online self-management program in     groups of 20-25, and they fill our additional online questionnaires at 6 month and one year.   "
224797|NCT00787969|"     This phase I/II trial studies the side effects and best dose of temsirolimus when given     together with cladribine and rituximab and to see how well it works in treating patients with     newly diagnosed mantle cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere     with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as     cladribine, work in different ways to stop the growth of cancer cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Giving temsirolimus together with cladribine and rituximab may kill more cancer cells.   "
224798|NCT00787982|"     In this study, the Visualase Thermal Therapy System will be used on metastatic brain tumors     that cannot be removed by surgery. Researchers want to find out if it is possible to use this     new device in subjects with 1-3 metastatic brain tumor(s), each measuring 3 centimeters (cm)     or smaller. The safety of the device will also be studied.   "
224801|NCT00788021|"     Patients who undergo kidney transplant must take medications to prevent organ rejection.     There are standard immunosuppressant medications such as prednisone, tacrolimus (Prograf),     mycophenolate mofetil(Cellcept) or sirolimus (Rapamune) that are given to patients to prevent     rejection. It is well known that patients on immunosuppressant medications are at increased     risk from viral infections, such as influenza. However, it is not well understood how     immunosuppressive medications may uniquely affect the immune response to infection. This     study will determine whether there are unique differences in the effects on the immune system     by these different immunosuppressive medications, particularly differences between tacrolimus     and sirolimus.   "
224802|NCT00788034|"     The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with     Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.   "
224803|NCT00788047|"     This drug-drug interaction study is being conducted to evaluate the potential effect of     Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450     2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.   "
224804|NCT00788060|"     This is a single center, Phase Ib study of Sunitinib and RAD001 in patients with advanced     RCC. The study design is a phase I interpatient dose-escalation with a dose expansion at the     maximum tolerated dose (MTD) in patients with metastatic RCC . In the dose escalation     portion, patients will be treated with sunitinib, given in an intermittent schedule (2 weeks     of daily dosing followed by one week off drug. RAD001 will be given daily. Escalation of both     drugs will occur as tolerated. Treatment will be arbitrarily divided into 3-week cycles, with     dose limiting toxicity (DLT) determined by Cycle 2 Day 0.   "
224805|NCT00788073|"     The study objective is to explore the efficacy, safety and tolerability of STX209 for     treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve     irritability and other typical problem behaviors associated with fragile X syndrome. We also     hypothesize that STX209 will be safe and well tolerated.   "
224806|NCT00788099|"     Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Plitidepsin in     Combination with Sorafenib or Gemcitabine in Patients with Advanced Solid Tumors or Lymphomas     to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of plitidepsin in     combination with sorafenib or gemcitabine in patients with advanced solid tumors or     lymphomas.   "
224807|NCT00788112|"     RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This clinical trial is studying how well vorinostat works in treating women with     ductal carcinoma in situ of the breast.   "
224808|NCT00788125|"     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs in chemotherapy, such as ifosfamide, carboplatin, and     etoposide, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving dasatinib together with ifosfamide,     carboplatin, and etoposide may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of dasatinib when     given together with ifosfamide, carboplatin, and etoposide and to see how well they work in     treating young patients with metastatic or recurrent malignant solid tumors.   "
224838|NCT00788567|"     This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept     administered as a component of standard immunosuppressive therapy in recipients of kidney     transplants. The anticipated time on study treatment is 3-12 months, and the target sample     size is 100-500 individuals.   "
224809|NCT00788138|"     Vitamin D insufficiency is common in patients with cystic fibrosis. The investigators study     will examine a large dose of vitamin D given to patients who have cystic fibrosis and are     admitted to the hospital for a pulmonary exacerbation to determine whether vitamin D can     improve clinical outcomes and whether the dose given is correct. The investigators hypothesis     is that vitamin D therapy will improve production of anti-microbial peptides and will     increase bacterial killing of microorganisms.   "
224810|NCT00788151|"     This trial will evaluate the use of a tetravalent vaccine against dengue.      Primary Objectives:        -  To describe the immune response to dengue before and after each vaccination with dengue          vaccine in two age cohorts of children previously vaccinated with yellow fever (YF)          vaccine        -  To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of          children.   "
224811|NCT00788164|"     RATIONALE: Vaccines made from DNA or a gene-modified virus may help the body build an     effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may     stimulate the immune system in different ways and stop tumor cells from growing. Applying     topical imiquimod to the cervix may be an effective treatment for cervical intraepithelial     neoplasia. Giving vaccine therapy together with imiquimod may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy and     to see how well it works when given with or without imiquimod in treating patients with grade     3 cervical intraepithelial neoplasia.   "
224812|NCT00788177|"     The purpose of this study is to assess the efficacy of pegaptanib (Macugen®) for neovascular     (exudative) age-related macular degeneration (AMD) when the first dose is administered to the     submacular space instead of vitreous body in cases when previous state-of-the-art treatment     for the AMD was deemed ineffective.   "
224813|NCT00788190|"     The purpose of this study is to create and test a treatment algorithm to guide the treatment     of distal radius fractures in patients 65 and older and to obtain level-one evidence to     determine the best method of treating distal radius fractures in this growing population     demographic.   "
224814|NCT00788203|"     This study is conducting preliminary testing to find out whether a particular educational     program can alter parental overcontrol of their children's eating. There is evidence from     previous studies that children who are irritable, cry a lot, tend to be overcontrolled and     are at high risk for developing overweight. If the education program can change parental     behavior the next study would examine whether this affects children's weight over a longer     period of time.   "
224855|NCT00788788|"     Currently it is common medical wisdom that HELIOX (mixture of Helium in Oxygen) with a     fraction of Helium below 60% is not effective in reducing airway obstruction. The     investigators test the hypothesis that HELIOX with a fraction of Helium below 60% is still     effective in relieving airway obstruction in a double-blind, randomized and controlled     clinical PoC study with experimental upper airway obstruction.   "
224815|NCT00788216|"     Purposes of this study: 1) To define comprehensive set of descriptive health states related     to treatment of cervical cancer (e.g. radical hysterectomy, whole pelvic radiation,     brachytherapy, chemoradiation) 2) To define set of descriptive health states related to     adverse events associated w treatment of cervical cancer (i.e. bladder dysfunction, pain,     enteritis, fistula formation) & 3) To derive, using a validated method, a set of QoL related     utility scores corresponding to these health states.   "
224816|NCT00788229|"     The purpose of this study is to determine whether artificial tears are safe and effective in     the treatment of Dry Eye Syndrome.   "
224817|NCT00788242|"     The purpose of this study is to evaluate the cardioprotective effects of a short term     infusion of glucose-insulin-potassium (GIK) during heart surgery.   "
224818|NCT00788255|"     Oxytocin is normally administered following delivery in pregnant patients to reduce     postpartum bleeding by increasing uterine tone. It is unclear whether the use of intravenous     oxytocin alters coagulation in pregnant patients. The purpose of the in-vitro study is to     assess the coagulation changes of oxytocin in blood samples from pregnant patients using     thromboelastrography (TEG). TEG is a point-of-care device which measures the viscoelastic     properties of clot formation, and can provide rapid and detailed information about     coagulation changes. We aim to collect blood samples from pregnant patients to assess the     in-vitro effects of synthetic oxytocin on coagulation using TEG.   "
224819|NCT00788281|"     Laparoscopic surgery has been widely accepted for its minimal invasion and safety. However,     whether it has the same survival benefit as the traditional open surgery in Chinese     population is still unknown. So we designed this study to evaluate the 3 year disease free     survival rate in the laparoscopic group versus the open surgery group.   "
224820|NCT00788294|"     The hypothesis of this study is that subcutaneous administration of tanezumab results in     lower drug exposure compared to intravenous administration of tanezumab.   "
224821|NCT00788307|"     RATIONALE: Radioactive drugs, such as radioactive iodine, may carry radiation directly to     tumor cells and not harm normal cells. Placing a gene called Ad5CMV-NIS in prostate cancer     cells may help the prostate cells take in more radioactive iodine and thus kill the cancer     cells. Drugs, such as liothyronine sodium, may protect the thyroid from the side effects of     radioactive iodine.      PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy given     together with radioactive iodine in treating patients with locally recurrent prostate cancer     that did not respond to external-beam radiation therapy.   "
224822|NCT00788320|"     Tuberculosis is a disease caused by a bacterium (a germ) that can cause illness in any organ     of the body, but most frequently causes disease of the lungs. TB is short for tuberculosis.     Treating TB requires several months (usually 6 months) of treatment, with the first 2 months     being intensive treatment with usually four medicines. Treatment is needed to keep the     infection from getting worse and to prevent death from TB.      Vitamin D is a hormone present in the human body to manage levels of some essential     electrolytes such as calcium and phosphate. Vitamin D is important for bone formation and     prevention of bone breakdown (osteoporosis) as the investigators age. There is also new     evidence that links vitamin D to function of our immune system as well. Even though our     bodies can make vitamin D and can also obtain vitamin D from our diet, most adults,     especially patients with tuberculosis have low vitamin D levels (are vitamin D deficient)     that need to be corrected. Full correction of low vitamin D levels requires 6 weeks or more     of weekly vitamin D supplements. There are several benefits to correcting vitamin D     deficiency (better bone health, better balance of calcium and phosphate), but it is not known     whether correcting vitamin D deficiency will lead to a better immune response to     tuberculosis. Preliminary data does suggest that vitamin D increases the levels of an     antimicrobial molecule (cathelicidin LL-37) in the body, possibly leading to better immunity     against tuberculosis. The primary objective of this pilot study is to assess the relationship     of vitamin D levels in patients with active pulmonary tuberculosis to levels of LL-37     cathelicidin in sputum and whole blood. The results of this study are needed in preparation     for larger studies that will evaluate the role of vitamin D supplementation as adjunctive     therapy to standard medical treatment for tuberculosis.   "
224946|NCT00789984|"     The purpose of this study is to determine whether some endothelium morphologic variables are     different between infectious and noninfectious uveitis group using a noncontact specular     microscopy device.   "
224823|NCT00788333|"     This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and     pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with     trastuzumab (Herceptin®) in subjects with advanced or metastatic Her-2-positive breast     cancer. In addition, the study is expected to identify the recommended dose or dose range of     BMS-754807 in combination with trastuzumab for Phase II studies and provide preliminary     evidence of anti-tumor activity in Her-2-positive breast cancer subjects after trastuzumab     failure   "
224824|NCT00788346|"     Prescribing decisions by clinicians are often thought to be simple: a patient's clinical     problem leads a prescriber to choose the optimal treatment. However, many factors other than     the patient's condition affect prescribing decisions, including the marketing of     pharmaceuticals. Clinicians are subjected to direct detailing by representatives of the     pharmaceutical industry, advertisements in medical journals and requests for specific     treatments from patients, who are increasingly exposed to direct-to-consumer (DTC)     advertising. These influences, often based on biased or inaccurate information, contribute to     a variety of problems in prescribing, including the unnecessary use of expensive, heavily     marketed medications.      Overcoming these influences requires innovative approaches. The movement toward widespread     adoption of electronic health records (EHRs) and electronic prescribing presents new     opportunities to educate both clinicians and patients at the time of medication prescribing.     This project, endorsed by the AHRQ-supported Centers for Education and Research on     Therapeutics (CERTs; www.certs.hhs.gov) and the U.S. Food and Drug Administration (FDA), aims     to test the effectiveness of computerized prescribing alerts and state-of-the-art educational     outreach to reduce the unnecessary use of heavily marketed medications. A second goal is to     improve clinicians' knowledge of industry marketing practices, so that they can more     effectively assess information provided by drug companies. Thus, the study has two specific     aims:      Specific Aim 1: To assess whether computerized prescribing alerts linked electronically to     patient educational material can reduce prescribing of heavily marketed medications.      Specific Aim 2: To assess whether group academic detailing increases clinicians' knowledge     about industry marketing practices and increases the effect of prescribing alerts.   "
224856|NCT00788801|"     This study is being done in healthy volunteers to help researchers understand how ABT-614     works in the human body, specifically in the brain. The PET imaging technique can be thought     of as a way to take pictures of chemical changes in the brain. To take a PET scan (picture),     a substance with low levels of radioactivity (radiotracer) has to be injected when you are in     the PET camera. The radiotracer is only radioactive for a short period of time. In this     study, PET is being used to measure how the study drug attaches to specific receptors in the     brain. The radiotracer used in this study, [11C]-(+)-PHNO, is currently being used for     studies in people at the CAMH PET Centre.   "
224857|NCT00788814|"     Study to assess the efficacy of a modified Pathways curriculum in treating depressive     symptoms in women with physical disabilities.   "
225181|NCT00793520|"     The purpose of this study is to evaluate the effect of milnacipran on how the brain processes     pain in patients with fibromyalgia and to assess the relationship between this effect and     brain activation patterns during functional magnetic resonance imaging.   "
224825|NCT00788359|"     Clinical and translational research in cystic fibrosis (CF) is hampered by a lack of     biomarkers that can be used to identify promising new therapies. There is an urgent need for     development and validation of biomarkers that more quickly predict the usefulness of     potential drugs in CF and might prognosticate clinical course. In particular, combinations of     protein biomarkers that can be obtained non-invasively offer great promise. The goal of this     project is to determine whether protein biomarkers in blood can demonstrate a beneficial     effect of treatment over two weeks. We intend to initially target an acute pulmonary     exacerbation in CF because we know that subjects being treated with intravenous antibiotics     and enhanced mucus clearance display clinical improvements within two weeks. We propose to     prospectively collect blood samples from a large cohort of well-characterized CF persons     serially during inpatient admissions for a pulmonary exacerbation and longitudinally during     annual visits. Through this proposal, we hope to identify a CF lung injury biomarker panel     that increases in the setting of an acute pulmonary exacerbation and improves rapidly     following intravenous antibiotic therapy. Additionally, we will begin to explore whether this     CF lung injury biomarker panel might also prognosticate clinical course including decline in     pulmonary function. Finally, this study will serve as an important source of blood samples     that will be banked for future biomarker and therapeutic studies designed to benefit the     entire CF community.   "
224826|NCT00788372|"     The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day     transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will     enter the body through the skin) in participants with chronic (lasting a long time) pain.   "
224827|NCT00788385|"     Multi-Center Study of ShuntCheck   "
224828|NCT00788398|"     Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a     common complication. There is currently little evidence as to which is the most effective way     to wash out these wounds. This study is a multi-center, prospective, randomized study. The     infection rates will be compared between irrigation using high pressure versus low pressure     versus gravity flow, and also saline versus a soap solution as the irrigation solution. The     results from this study will help to determine the best method of washing out open fractures     wounds. In this study, all open wounds will be washed out using methods commonly used by     orthopaedic surgeons   "
224829|NCT00788424|"     This protocol relates to a phase II randomized double blind, placebo controlled study of the     AS101 topical application for the treatment of mild to moderate Psoriasis.   "
224830|NCT00788463|"     The purpose of this study is to determine if intranasal Beclomethasone delivered by aerosol     or spray is more effective in treatment of nasal polyps.   "
224831|NCT00788476|"     Objectives:        1. To explore current lifestyle practices, health status, and quality of life among          childhood cancer survivors and parent/guardians who are identified as primary          caregivers.        2. To explore childhood cancer survivors' and primary caregivers' awareness of future          health risks.        3. To explore interest in various lifestyle interventions and delivery channels among          childhood cancer survivors and their primary caregivers.        4. To explore factors which may serve as mediators or moderators of future lifestyle          interventions that target childhood cancer survivors and their primary caregivers,          e.g., strength of the caregiver-child bond, geographic distance from one another, and          level of education.   "
224832|NCT00788489|"     The overall goal of this study is to determine how FDG-PET, breast MRI and breast ultrasound     can be incorporated into the assessment of treatment responses in women with LABC undergoing     neoadjuvant chemotherapy. A prospective cohort study will be conducted evaluating the ability     of FDG-PET, breast MRI and breast ultrasound to detect the presence of residual tumour in     patients with LABC who have completed treatment with neoadjuvant chemotherapy prior to     mastectomy.   "
224833|NCT00788502|"     The goal of this study is to determine the effect of Healing Touch (HT) on the stress,     anxiety, and self-efficacy experiences of women undergoing in vitro fertilization (IVF) in a     randomized, controlled design. HT is a gentle, non-invasive form of energy-balancing work     that promotes relaxation.   "
224834|NCT00788515|"     The primary objective is to compare the potential for next-day residual effects of     volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning     using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic     primary insomnia and sleep maintenance difficulties.      Secondary objectives are to compare the clinical safety of both products, including the     potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to     compare the efficacy of both products on subjective sleep parameters and to compare the     effects of both products on patient's daytime functioning.   "
224835|NCT00788528|"     The purpose of this open-label extension study is to evaluate the safety and efficacy of     velneperit (S-2367) in obese subjects.   "
224839|NCT00788580|"     RATIONALE: Pazopanib and temsirolimus may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Pazopanib may also blocking blood flow to the tumor.     Giving pazopanib together with temsirolimus may be an effective treatment for advanced solid     tumors.      PURPOSE: This phase I trial is studying the side effects and best dose of temsirolimus when     given together with pazopanib in treating patients with advanced solid tumors.   "
224840|NCT00788593|"     The primary efficacy objective of this study is to evaluate the difference in coefficient of     fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low     dose of EUR-1008 (APT-1008) in the treatment of signs and symptoms of malabsorption in     participants with EPI associated with CP. This study is sponsored by Aptalis Pharma (formerly     Eurand).   "
224841|NCT00788606|"     This study evaluates the use of the standard treatment R-CHOP plus the anti-VEGF drug,     bevacizumab and whether this treatment is feasible in patients with stage II, III and IV     diffuse large B cell lymphoma (DLBCL).   "
224842|NCT00788619|"     Improvements in In-Vitro Fertilization (IVF) outcomes have largely been due to the generation     of excess embryos allowing for multiple embryo transfer. Unfortunately this has also     increased the risk of multiple pregnancy with associated maternal and neonatal morbidity and     mortality. The investigators believe that the concentration of nitric oxide metabolites     measured in the culture medium from the first day of culture can identify the best quality     embryos allowing us to transfer a limited number of embryos without compromising the optimum     chance for pregnancy.   "
224843|NCT00788632|"     The purpose of this study is to rigorously test the incremental impact of simple,     generalizable interventions to improve healthcare among older women at high risk for     osteoporosis. Building on the experience of our University of Alabama at Birmingham (UAB)     interdisciplinary team we have designed an innovative, scientifically rigorous, and highly     feasible implementation research project in partnership with two Kaiser Permanente (KP)     research centers. Kaiser Permanente, one of the Nation's largest Healthcare Organizations,     uses an integrated electronic medical record (EMR), with full capture of pharmacy, clinical     (including BMD results), and claims data, and cares for a racially/ethnically,     socio-economically, and geographically diverse population. To address innovative questions in     implementation research, we will perform a multi-modal group randomized trial involving over     18,000 patients seen by over 330 primary care providers (PCPs) at 25 KP facilities in the     Northwest and Southeast. If proven effective, our system-centered and patient-centered     approach will advance the state of implementation science and be applicable to evidence     implementation in other musculoskeletal disorders and to other health care settings.   "
224844|NCT00788645|"     People with Chronic Obstructive Pulmonary Disease (COPD) often have periods during the year     when their symptoms become worse. These are often due to an infection and are called     exacerbations by doctors. Exacerbations are more common in the winter and also seem to be     related to particular types of weather. As well as forecasting the weather the UK Met Office     has developed a system to try to predict when exacerbations are likely to occur. The main     purpose of this research study is to find out whether the Met Office forecasting service can     predict when exacerbations are more likely to occur and whether the advice given during the     predicted higher risk periods leads to fewer patients having an exacerbation or if it reduces     the impact of the exacerbation. The study will also assess if there is a link between viral     or bacterial infection and breathing problems that occur during the study period. The study     will also collect information about possible causes of the breathing problems and what     happens to the person afterwards. The results of this study will help us learn more about     breathing problems which may lead to new research studies that would aim to improve the care     of people with COPD.   "
224845|NCT00788658|"     Irritable bowel syndrome (IBS) affects approximately 10-15% of the adult population. This     condition is characterized by abdominal pain, altered bowel habit, abdominal bloating and     reduced quality of life. Options for treating IBS include pharmacotherapy, psychotherapy,     hypnotherapy and cognitive behavior therapy (CBT). Available data on the effectiveness of CBT     in IBS patients in Israel are scarce.      The aim of the present study is to assess effectiveness of CBT as compared with standard     therapy for IBS patients in Israel The course of CBT consisted of up to six 40 min sessions,     and included education about IBS and techniques to reduce focusing on symptoms and to manage     stress.Standard therapy includs life style modifications.      The primary outcome measure was the score on a symptom-severity scale specific to IBS.   "
224846|NCT00788671|"     The goal of this clinical research study is to learn the level of effectiveness of the Mirena     intrauterine device (levonorgestrel IUD) in treating hyperplasia of the lining of the uterus     and/or early-stage cancer of the lining of the uterus. Researchers want to learn if the     levonorgestrel IUD can help to shrink or slow the growth of the disease.   "
224847|NCT00788684|"     This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with     rituximab in subjects with CD20-positive lymphoproliferative disorders. The extension portion     of the study will allow active subjects to continue to receive ABT-263 for up to 7 years     after the last subject transitions with quarterly study evaluations.   "
224848|NCT00788697|"     The purpose of this study is to demonstrate the superiority of SonoVue®-enhanced ultrasound     versus unenhanced ultrasound for characterization of Focal Liver Lesions using final     diagnosis based on histology or combined imaging/clinical data as truth standard.   "
224849|NCT00788710|"     The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to     placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.   "
224850|NCT00788723|"     The aim of the study is to evaluate the cortical excitability in the severe brain injured     patients. We hypothesize that:        1. There is a continuous decrease in intracortical inhibition from healthy subjects to          awake patients with severe brain injury, and to patients with impaired consciousness.        2. Decreased intracortical inhibition correlate with the degree of impairment assessed with          the clinical scores in patients with severe brain injury.   "
224851|NCT00788736|"     The main objective of the study is to develop or validate a clinical prediction rule for     major bleeding in patients on oral anticoagulant therapy who have been safely anticoagulated     without bleeding or venous thromboembolism (VTE) recurrence for at least 3 months since     diagnosis and are being considered for long-term oral anticoagulant therapy.   "
224852|NCT00788749|"     This is the first randomized parallel group clinical trial looking at oral prednisolone     induced medical nasal polypectomy followed by maintenance on topical steroid therapy in     patients with nasal polyposis. This study also looks at the effect of aspirin sensitivity and     the factors linking nasal polyps with asthma. We have also taken baseline measurements of a     variety of blood, surface and biopsy markers to assess for potential to predict steroid     response. Finally, the still unchartered link between nasal polyps and asthma will be     explored by measuring Staphylococcal superantigens in serum before and after treatment.   "
224853|NCT00788762|"     Taxiarchis, a small village in Northern Greece with 1060 inhabitants, was considered to have     a surprisingly high incidence of glaucoma. This isolated population located on Mount     Holomondas appeared to be enriched for familial glaucoma. Based upon the high reported     incidence of glaucoma in Taxiarchis and previous findings of the Thr377Met myocilin mutation     in the Greek population,the investigators undertook a community-based study to determine if     this variant was present in this village.   "
224854|NCT00788775|"     Given the poor prognosis and limited treatment options available for patients with mucosal or     acral/lentiginous melanomas who develop metastatic disease, genetic discoveries of KIT     mutations in these cancers present the need to test multi-targeted kinase inhibitors with     potent KIT inhibitory activity in this patient population. Imatinib and other tyrosine kinase     inhibitors (TKIs) have the potential to be effective in this patient population, but patients     may develop resistance to treatment. Therefore, in this study, we propose to test nilotinib     in patients with metastatic mucosal, acral, or chronically sun-damaged melanoma following     treatment with another TKI.   "
224858|NCT00788827|"     This is a phase I study to assess the safety and tolerability of infusing expanded stem cells     into the pancreas of patients with type I diabetes and a successful renal transplant. The     stem cells used in this study occur naturally in the body and are collected from each     recipient by a procedure called leukapheresis. The cells are then expanded and differentiated     into insulin-like cells in a sterile suite before being injected into the body or tail of the     pancreas of the recipient.   "
224859|NCT00788840|"     This is a study designed to compare the effects of 2 long-acting insulins, detemir and     insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic     control and fat and muscle gene expression over a 6 month period.   "
224860|NCT00788853|"     This study is conducted in Asia. The aim of this observational study is to evaluate current     status of diabetes management, control, complications in diabetic subjects in Asia. Further     perceptions and practices of physicians and subjects about diabetes management in Asia will     be evaluated.   "
224861|NCT00788866|"     Infants with intrauterine growth restriction are known to be at increased risk for long term     neurodevelopmental delay into adulthood. The main mechanism for this is likely decreased     blood flow to the brain secondary to altered placental blood flow. Antioxidants may serve to     protect the developing brain from this process. Animal studies have shown that pomegranate     juice protects the fetal brain from injury in a model of stroke. This clinical trial is     intended to evaluate if giving mothers pomegranate juice during the last several weeks of     pregnancy can help protect intrauterine growth restricted babies' brains.   "
224862|NCT00788879|"     The Tu Salud, Si Cuenta (TSSC) media campaign uses behavioral journalism, community outreach     and environmental changes to promote physical activity and nutritional changes among     disadvantaged Mexican-Americans living along the U.S./Mexico border. This intervention posits     that increased physical activity and increased fruit and vegetable consumption with smaller     portion sizes will result in a decrease in obesity prevalence and diabetes incidence in this     population.   "
224863|NCT00788892|"     The study investigates if CPX-351 will be a) more effective than the standard AML treatment     and b) more tolerable than the standard AML treatment regimens.      The study compares the investigational product CPX-351 vs the standard treatment for AML in     this patients age group.   "
224864|NCT00788905|"     The purpose of the study to determine whether the level of inflammation may be decreased, the     lifespan of red blood cells increased and the clearance of waste products in the blood     improved through the use of the Allient System as compared to conventional hemodialysis.   "
224877|NCT00789074|"     Varenicline (Champix) is a relatively new medicine that is effective in helping people to     quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24     weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before     stopping smoking is better than the standard 1-week of use prior to stopping.      The study will recruit 100 smokers who want to stop. They will be randomly allocated to     receive varenicline(4−weeks) or placebo (3−weeks followed by 1−week of active treatment as     indicated by standard prescribing practice), followed by a 12−week open label treatment     period where all participants will receive varenicline.   "
224878|NCT00789087|"     The purpose of this study is to analyze and compare radiological lung expansion after talc     pleurodesis performed either by videothoracoscopy or chest tube and correlate it with     clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of     life and survival.   "
224865|NCT00788918|"     Patients with HCV infection often suffer from chronic fatigue, depression and reduced     cognition, even before evolving severe liver fibrosis, liver cirrhosis and hepatic     encephalopathy.      It is currently unclear to what extent the symptoms er due to a direct pathological effects     of the virus itself, or due to pre-existing psychiatric disease. There is a complex     relationship between prior or existing drug abuse, psychiatric disease and HCV infection,     that makes it difficult to establish cause-effect relationships.      A biological mechanism has been suggested to contribute to development of cerebral     dysfunction in the patients. According to the prevailing Trojan Horses hypothesis circulating     lymphocytes cross the blood brain barrier carrying HCV to the central nervous system and     virus is subsequently replicated in the macrophages and the microglia in brain as a separate     compartment. As part of the immunological response to viral replication, neurodegenerative     processes takes place with a harmful effect on the neural circuit and cerebral function.     Identification of HCV RNA negative strand, a replication product, in brain tissue from HCV     patients, as part of autopsy studies, supports the hypothesis. Moreover, HCV patients have     also been observed with abnormal metabolic concentrations in the frontal white substance and     the basal ganglia by MRI spectroscopy compared to control groups.      The overall study objective is to assess cerebral function with particular emphasis on     cognitive functions in HCV patients (genotypes 1,2,3 and 4) by use of a neuropsychiatric test     battery. Furthermore, the patients will be examined by MRI, including magnetization transfer,     diffusion tensor and contrast perfusion, in order to perform measurements of cerebral     volumetric and microstructure. Finally, HCV analysis, including viral sequences and cytokine     profiles, in serum and cerebrospinal fluid will be carried out in the study population.   "
224866|NCT00788931|"     The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both     intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel.     The study will evaluate safety and efficacy of the combination in adult female patients with     HER2+ metastatic breast cancer   "
224867|NCT00788944|"     This is a study to determine the percentage of patients with depression who are treated with     extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®) who are Poor Metabolizers     (based on the levels of the drug in the blood) at 2D6 (a system in the liver that breaks down     some medications and other chemicals).   "
224868|NCT00788957|"     This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2     part, phase 2 study designed to evaluate the safety and efficacy of rilotumumab or ganitumab     in combination with panitumumab versus panitumumab alone in patients with metastatic     colorectal cancer whose tumors are wild-type KRAS status.   "
224869|NCT00788970|"     In the current study we will study the effect of adding acupressure (shiatsu) to conventional     therapy in treating individuals with schizophrenia.   "
224870|NCT00788983|"     Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor     combinations and various OEM pulse oximeter modules and sensor combinations during induced     hypoxia (desaturation).   "
224886|NCT00789191|"     This trial is conducted in Asia, Europe and North America. This trial aims for comparison of     the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue     with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.   "
224871|NCT00788996|"     Main objective: to determine the effectiveness of a brief opportunist educational performance     directed to the parents who smoke -- inside the context of programmed visits of paediatrics     in primary care -- to reduce the exposure of the babies to secondhand smoke (SHS)      Secondary objectives:        1. Smoking reduction / quitting of the mother and/or the father        2. To determine the relationship between the level exposure to SHS and main related          variables   "
224872|NCT00789009|"     This study will investigate HIV infection and associated conditions by monitoring infected     patients. The study will also serve as a means for recruiting HIV-infected individuals to     NIAID s ongoing clinical and laboratory studies and supporting the institute s infectious     disease training program by providing Infectious Disease fellows with ongoing training in the     management of HIV infection.      People 18 years of age and older with suspected or confirmed HIV infection who live in the     Washington, D.C., metropolitan area may be eligible for this study. Physician referral is     required.      Participants come to the NIH Clinical Center a minimum of once every 3 to 4 months for     evaluation with a physical examination; blood tests for research purposes, safety, immune     status and viral load; and response to any treatment they may be receiving. Other procedures,     such as a biopsy, are done only as needed for standard medical practice, and informed consent     is obtained before any such procedure is done. Treatment offered is consistent with standard     medical practice; no experimental treatments are offered under this protocol.   "
224873|NCT00789022|"     The goal of our research is to check the levels of D-Serine, Glycine, and other Glutamatergic     amino acids, in patients with First Psychotic Episode (FPE). These patients are in the early     stage of the disease, treated with neuroleptics for short periods of time, and are usually     hospitalized for the first time. The hypothesis of the research is that we will find low     levels of Glycine and D-Serine in these patients. Following an Anti-psychotic treatment we     will expect these levels to return to the norm, and that this correction will be accompanied     by a reduction of positive and negative symptoms.      In addition, we will check the D-Serine and Glycine levels in the plasma of first degree     relatives of the patients and a group of healthy subjects. The results of this study might     support the hypothesis that the Glutamatergic system in involved in the pathology of     Schizophrenia from it's early stages.      In addition, we will check the levels of Oxytocin and Estrogen in the plasma of patients in     FPE. Our hypothesis is that we will find low levels of Estrogen and High levels of Oxytocin     in this group of patients. The results of the study might support the hypothesis that     Estrogen and Oxytocin are involved in the pathology of Schizophrenia from it's early stages.   "
224874|NCT00789035|"     The objective is to investigate the efficacy, safety and pharmacokinetics of three different     doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes     mellitus with insufficient glycemic control. In addition an open-label metformin arm will be     assessed   "
224875|NCT00789048|"     Goal of the research        1. To check the viability of Operating Table Position Simulating Radiographs, while          positioned on the contralateral side.        2. To determine whether knowledge about the angles displayed on this radiograph (pelvic          tilt) influences the accurate positioning of the acetabular cup during the Total Hip          Replacement procedure.   "
224876|NCT00789061|"     Disequilibrium between acid and base in the inner ear was suggested to be an important factor     leading to hearing impairment associated with SLC26A4 mutations. For acid-base homeostasis in     the inner ear, gastric-type proton pumps might demonstrate antagonistic effects to pendrin,     the protein encoded by SLC26A4. To investigate whether proton pump inhibitors might prevent     or treat acute fluctuating hearing loss related to SLC26A4 mutations, we launch the current     double-blind randomized clinical trial.   "
224897|NCT00789347|"     The purpose of this study is to determine whether patients with neuropathic pain has abnormal     excitability in somatosensory cortex and abnormal sensory-motor connections.   "
224879|NCT00789100|"     Nottingham Primary Care Trust has launched telemonitoring to support: independent living and     self-management ability of people with congestive heart failure (CHF), chronic obstructive     pulmonary disease (COPD) and co-morbidities; and reduce the health care utilisation     associated with these patients, including the number of hospitalisations, GP visits and     community matron and specialist community nurse home visits.      The Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) will evaluate     the technology and its impact of this telemonitoring system on quality of care (i.e. process     measures), patient outcomes and direct healthcare costs from an NHS perspective.   "
224880|NCT00789113|"     People over 65 years of ag break down (metabolize) drugs differently than younger adults. It     is not known why this happens or how elderly people absorb or break down these drug     differently. These difference may show that elderly individuals need lower doses of     medications to avoid possible toxicity. We are interested in studying how yor body absorbs     and breaks down your lamotrigine medication. This research may indicate that doses of     lamotrigine should be lowered as people get older.   "
224881|NCT00789126|"     Study to evaluate the safety and tolerability of single ascending doses and multiple     ascending doses of VX-509 administered to healthy male and female subjects   "
224882|NCT00789139|"     Post Marketing study, Interventional, Prospective, non randomised      Describe how the MD is using the information of the ICM in addition of standard FU(clinical     exam and holter 24h)post AF ablation(1 year FU).   "
224883|NCT00789152|"     This was a study to measure the ability of desloratadine and levocetirizine to decrease nasal     obstruction in subjects who had study-induced allergic rhinitis. Study participants had     allergic rhinitis symptoms induced in a Vienna Challenge Chamber and then received     desloratadine or levocetirizine for 8 days. After at least a 10 to 35-day washout period     (time when no drug is given), subjects received the opposite treatment for 8 days. Subjects     had their total nasal symptom measured.on the 8th day of each treatment period.   "
224884|NCT00789165|"     The purpose of this study is to determine if quinidine therapy (not guided by the results of     electrophysiologic studies) will reduce the long-term risk of arrhythmic events in     asymptomatic Brugada Syndrome.   "
224885|NCT00789178|"     Patients suffering from Fibromyalgia will be examined for the presence of memory and/or     cognitive impairment using specific psychological tests.      Their results will be compared to those with active RA associated with pain and with a normal     control group.   "
224887|NCT00789204|"     The Global Postural Re-Education is a global approach for the treatment of musculoskeletal     disease. Using specific progressive posture for stretching particular shortened chain muscle     the method wants to equilibrate the never-ending war between static and dynamic muscles by     guiding the patient in a particular breathing pattern to maintain a correct posture and     feeling it.   "
224888|NCT00789217|"     This study aims to compare the readings of skin testing results in patients with suspected     penicillin allergy between in-house penicillin test preparation and commercial available     penicillin testing kit.   "
224889|NCT00789230|"     The purpose of the present study is to investigate whether or not the use of mesh is     indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence.     This method is regularly used in umbilical hernia reconstruction although most surgeons     repair small hernias using suture repair (fascia adaptation). Especially risk factors for     hernia recurrence such as hernia size and BMI > 30 kg/m2 need to be evaluated and correlated     to the method of hernia repair.   "
224890|NCT00789243|"     Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the     heart. Current treatments are designed at relieving this blockage as quickly as possible to     minimise damage to the heart muscle. However in restoring the supply of blood local damage     known as ischaemia-reperfusion injury may occur. The aim of this study is to assess how     clot forming and clot dissolving pathways are affected during this process, and examine the     role of a natural inflammatory hormone, bradykinin. This will help us to understand the     mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for     heart attacks.   "
224891|NCT00789256|"     The purpose of this study is to determine the response rate of the combination of bortezomib     and melphalan in patients with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic     Syndromes (MDS).   "
224892|NCT00789269|"     This study will determine if rhubarb will reduced the incidence of pneumonia and improved     recovery from an acute stroke. The study is designed to look at both infection rate and     overall recovery and recovery of motor function, for example muscle strength and     coordination.   "
224893|NCT00789282|"     The purpose of the study is to determine the efficacy of a family physician practice-based     model of chronic disease management (CDM) based in Primary Care Networks (PCN's) that is     integrated with the Capital Health Regional Diabetes Program for care of patients with type 2     Diabetes Mellitus.   "
224894|NCT00789295|"     The aim of this intervention study was to evaluate in type 2 diabetic patients the effects on     postprandial lipemia and other metabolic parameters (in both everyday life conditions and     after a standard test meal) of two diets, one moderately rich in CHO, rich in fibre and with     a low glycemic index (Mediterranean diet), and the other low in CHO and rich in MUFA (Low-CHO     diet).Since adipose tissue, mainly through its lipolytic activities, is considered as having     a pivotal role in the regulation of postprandial lipid metabolism, a further aim of our study     was to clarify the role of adipose tissue in modulating the postprandial lipid response     induced by the two dietary approaches by evaluating the activities of lipoprotein lipase     (LPL) and hormone-sensitive lipase (HSL).   "
224895|NCT00789308|"     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells     are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess     the safety and effectiveness of low molecular weight sulfated dextran (LMW-SD) on     post-transplant islet function in people with type 1 diabetes who have responded to intensive     insulin therapy.   "
224896|NCT00789321|"     This study will evaluate methodologies for measuring pedal edema associated with calcium     channel blockers in middle-aged and elderly subjects and patients with hypertension.   "
224900|NCT00789386|"     Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and     leads to deterioration of quality of life. An injury or wound can lead to long term changes     in the nervous system that make the skin more sensitive at and near the injury; this is     termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the     synaptic interaction between neurons.      Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in     animal studies the investigators have discovered previously unrecognized effects of opioids.      Intradermal injection of capsaicin (injection of pepper extract into the skin) is an     established pain model in humans. The investigators want to test the influence of     remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal     capsaicin in human volunteers in a double blind cross-over prospective active placebo     controlled clinical trial.   "
224901|NCT00789399|"     This trial is a prospective, single-center Phase II randomized study to demonstrate the     superior efficacy of Fondaparinux Sodium subcutaneous injections in patients undergoing CABG     surgery (isolated and redo isolated) versus treatment with placebo. All consecutive patients     scheduled for CABG surgery that meet the general inclusion and none of the exclusion criteria     will be considered for enrollment in the study.      Consecutive patients will be randomized on the day of admission prior to their CABG surgery     into one of two groups. One group will be randomized to the placebo while the second group     will receive 2.5 mg Fondaparinux Sodium injections. Both groups will receive routine     mechanical prophylaxis as determined by the treating physicians. Group randomized to receive     Fondaparinux Sodium will receive a 2.5 mg SQ daily drug dose starting 12 +/- 2 hours     post-wound closure or the following day in the morning (at the discretion of the     cardiothoracic surgeon). The second dose would be administered 24 hours later and the dosing     will then be once a day. The group randomized to placebo will receive subcutaneous equivolume     isotonic saline at the same time points described above.      Patients randomized will receive a 2.5 mg dose of Fondaparinux Sodium or placebo     subcutaneously for a total of 3-9 days post CABG with day 1 being the day of surgery. The     drug will be discontinued if the patient is discharged before day 9. If the patient stays for     more than 9 days inside hospital, a duplex would be obtained per protocol and further DVT     prevention measures would be instituted per the discretion of treating physician.      Patients will be assessed daily while hospitalized for any symptoms and adverse reactions and     will undergo laboratory testing (CBC, PT/INR, PTT and UA) as specified in the protocol.     Post-op day 3-9(no later than 2 days after the last preventive drug dose) patients will     undergo the protocol specific lower limb venous duplex scan and earlier if symptomatic.     Patients will also be contacted (phone/office visit) for follow-up 25-35 days post CABG to     assess for signs or symptoms of deep venous thrombosis or thromboembolism and for any     potential complications.   "
224902|NCT00789412|"     The hypothesis of the study is: Does the Surgical Stress Index (SSI) correlate with the     Behavioral Pain Scale (BPS), the Ramsay Sedation Scale (RSS)and/or the Behavioral Pain     Scale(BPV) and can therefore be used to monitor the quality of analgosedation in     noncommunicative intensive care unit patients?   "
224903|NCT00789425|"     The purpose of this study is to determine whether the intake of a daily dosage of     standardized olive extract provides any protection against bone loss.   "
225199|NCT00799578|"     The purpose of this study is to determine whether cysteamine will effectively reduce or     reverse the biologic markers of steatohepatitis in patients.   "
224904|NCT00789438|"     The Surgical Pleth index (SPI) has been introduced as a non invasive tool to measure stress     and pain during surgery. Preliminary studies were performed in patients under general     anaesthesia with propofol and remifentanil. These trials showed a good correlation between     SPI and aching procedures and a negative correlation between SPI and the remifentanil dosage.     Hence, it was concluded that SPI may be a bedside tool to measure `pain` during surgery. So     far, no study investigated SPI during regional anaesthesia.   "
224905|NCT00789451|"     Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the     heart. Current treatments are designed at relieving this blockage as quickly as possible to     minimise damage to the heart muscle. However in restoring the supply of blood local damage     known as ischaemia-reperfusion injury may occur. The aim of this study is to assess how     clot forming and clot dissolving pathways are affected during this process, and examine the     role of a natural inflammatory hormone, bradykinin. This will help us to understand the     mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for     heart attacks.   "
224906|NCT00789464|"     Probiotics are dietary supplements containing potentially beneficial bacterial strains such     as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in     hundreds of studies using adults over the last 30 years. Very few studies have been conducted     with children. UTI in girls occur when virulent bacteria migrate from the rectum and colonize     the vagina and peri-urethral mucosa, thus gaining access to the bladder.      This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics +     placebo) to determine if UTIs are decreased when the probiotics are given.   "
224907|NCT00789477|"     This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of     Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular     edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and     EU.   "
224908|NCT00789490|"     Deficiencies of iron and folic acid during pregnancy can lead to adverse outcomes for the     fetus, thus supplements are recommended. Adherence to current tablet-based supplements is     documented to be poor. Recently a powdered form of micronutrients has been developed which     may decrease side-effects and thus improve adherence. However, before testing the efficacy of     the supplement as an alternate choice for supplementation during pregnancy, the     bioavailability of the iron needs to be determined. The objective of this study is to measure     the relative bioavailability of iron and folic acid from a powdered supplement that can be     sprinkled on semi-solid foods or beverages versus a traditional tablet supplement in pregnant     women.   "
224909|NCT00789503|"     Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L     lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of     vitamin D3.      Objective: We wanted to characterize the safety and efficacy of fortifying bread with a     biologically meaningful amount of vitamin D3.   "
224910|NCT00789516|"     Hypercoagulable state is well recognized in patients with β-thalassemia. Evidences of     hypercoagulability include abnormal expression of phosphatidylserine on red blood cell (rbc)     surface and consequent increased platelet activation and thrombin generation. In addition, a     reduction of anticoagulants i.e. proteins C and S and antithrombin (AT) was demonstrated.     However, coagulable state in patients with β-thalassemia following stem cell transplantation     (SCT) has not been characterized.   "
224911|NCT00789529|"     The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when     cared with two different multi-purpose solutions over a two week wearing period.   "
224947|NCT00789997|"     The purpose of this study is to determine whether treatment with antibiotics plus a TNFalpha     antagonist will provide more effective treatment for acute COPD exacerbation compared to the     current standard treatment of antibiotics plus prednisone.   "
224912|NCT00789542|"     Strokes occur when blood flow to part of the brain is interrupted. Patients are often     bedbound for several days or weeks although if they survive, most will make some recovery.     The lack of mobility encourages blood clots to form in the legs − so called deep venous     thrombosis or DVT. About 10% of patients will develop these. Pieces of this clot may break     off and can be carried by the bloodstream to the lungs. These clots, called pulmonary emboli,     can stop the heart and can cause patients with stroke to die suddenly. A treatment which     reduces the risk of DVT after surgery is intermittent pneumatic compression (IPC). Inflatable     sleeves wrapped around the legs inflate at intervals squeezing blood up the legs, increasing     the blood flow, and decreasing the likelihood of clots forming − at least that is the     theory!. Although this sounds uncomfortable, most people actually quite like the sensation!     There have been some small randomised trials of IPC in stroke patients, particularly those     with intracerebral bleeding. However, these studies although encouraging have not provided     enough information to persuade clinicians to use this treatment routinely in stroke units.     The proposed study will include 2000 patients who have had a stroke and who have been     admitted to a stroke unit.      Patients who cannot walk independently, and who are at greatest risk of DVT will be invited     to join the study. If they agree they will be randomly allocated to having routine care plus     IPC or just routine care. Patient in both groups will have routine ultrasound scans on their     legs to detect DVTs. The study will establish whether IPC reduces the risk of DVT. This     result could improve the outcome of many thousands of patients each year.   "
224913|NCT00789555|"     The purpose of this study was to assess local nasal adverse effects, as well as systemic     effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase     Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).   "
224914|NCT00789568|"     Sapropterin dihydrochloride (subsequently referred to as sapropterin) (Kuvan®) was approved     by the FDA for the treatment of hyperphenylalaninemia in 2007. Preclinical and clinical     studies and post-marketing surveillance have not demonstrated any specific cardiovascular     concerns with sapropterin (Kuvan®). Nonetheless, nonantiarrhythmic drugs may have the     potential to prolong QT interval, leading to potentially fatal ventricular tachycardias,     including torsades de pointes. As part of the post-marketing commitment, a thorough QT/QTc     study will be conducted according to ICH guidelines.   "
224915|NCT00789581|"     This is a randomized, Phase III, open-label, multicenter study.   "
225345|NCT00801957|"     Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were     considered to benefit from vaccination to prevent invasive disease caused by Neisseria     meningitides serogroup C.   "
224916|NCT00789594|"     The investigators propose a cluster-randomized controlled trial (RCT) of computerized     point-of-care alerts in the EHR to prevent errors related to laboratory monitoring at the     initiation and continuation of drug therapy and a results management system to prevent errors     related to the delay in follow-up of abnormal laboratory testing.   "
224917|NCT00789607|"     This purpose of this study is designed to compare two types of images; magnetic resonance     imaging (MRI) and Trans-Rectal Ultrasound (TRUS) to see which one performs more accurately     for the image-guided insertion of Fiducial Markers(FMs) within the tumour. Though effective     for guiding FM placement at the poles of the prostate gland due to excellent visualization of     the prostatic boundaries, TRUS may not be ideally suited for marking the GTV. Conventional     TRUS is neither sufficiently sensitive nor specific for accurate visualization of     intra-prostatic tumor. A new interventional MRI technique enables needle guidance to the     gross tumour Volume (GTV) for FM placement. It is of particular importance that both     techniques be evaluated to enable which one is more effective so that it can be implemented     in the designs of future trials involving dose-escalation to prostate.   "
224918|NCT00789620|"     Effective perioperative analgesia is the key to postoperative rehabilitation. An intriguing     body of evidence suggests that short-term administration of intravenous lidocaine may produce     pain relief that far exceeds both the duration of infusion and the half-life of the drug.     When pain relief is provided, concomitant anal-gesic medication can be reduced, side effects     from pain relieving medication minimized with a potential for a more rapid postoperative     recovery and less complications. IV application of lidocaine should de-crease the duration of     bowel dysfunction. We hypothesise that i.v. application of lidocaine in a standard     antiarrythmic dose can significantly improve acute rehabilitation after laparoscopic     urological surgery and so shorten the hospital stay (primary outcome). We expect that the     intraoperative inflammatory response can significantly be reduced.   "
224919|NCT00789633|"     The objective of this study is to compare the efficacy and safety of masitinib in combination     with gemcitabine to placebo in combination with gemcitabine in patients with     advanced/metastatic pancreatic cancer.   "
224920|NCT00789646|"     The propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due     to subconjunctival antibiotic and antifungal injection.   "
224921|NCT00789659|"     It is the belief of the investigators that the current trends in complication rates     associated with fixation of pelvic ring injuries and acetabular fractures in the obese are     unacceptable. The overwhelming majority of these complications can be attributed to problems     with surgical wound healing. The investigators feel that if a cost effective and easily     performed intervention can be prospectively utilized in a specific at-risk orthopaedic trauma     population in order to control a potentially devastating complication, then efforts in     discovering such an intervention may prove valuable. It is our hypothesis that obese patients     treated with V.A.C. therapy after standard closure of trauma-related, operative orthopaedic     incisions will have fewer postoperative wound complications.   "
224922|NCT00789672|"     This pilot study is being conducted as a prelude to a randomized trial to compare     levodopa/carbidopa plus patching versus patching alone. The purpose of the pilot study is to     demonstrate recruitment potential, to provide prospective data on the tolerability of     levodopa as a treatment for amblyopia, to provide limited data on its safety, to provide     limited data on it's efficiency, and to provide data to assist in selecting a dose to use in     a subsequent phase 3 randomized trial. In addition, this study will provide the opportunity     for investigators to gain experience in using levodopa prior to a randomized trial.   "
224923|NCT00789685|"     The purpose of this study was to assess the safety, tolerability and preliminary efficacy of     FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory     Distress Syndrome (ARDS).   "
224978|NCT00790400|"     This study will evaluate the safety and efficacy of RAD001 in treating patients with     Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic     Lymphangioleiomyomatosis.   "
224926|NCT00789724|"     Thousands of patients die daily from early and late complications of a heart attack (acute     myocardial infarction, AMI). Patients surviving AMI remain at high risk of death from adverse     cardiac remodeling (dysfunction and enlargement of the heart) leading to heart failure     (weakening of the heart).      Current interventions proven to reduce adverse remodeling and progression to heart failure     include early reperfusion (restoring blood flow to the heart muscle) and long-term use of     medicines that block the effects of hormones (such as angiotensin II, norepinephrine and     aldosterone) involved in adverse remodeling. Despite these treatments, however, many patients     continue to develop heart failure within 1 year of AMI. These patients are at very high risk     of death.      Numerous changes occur in the hearts of patients after AMI that lead to adverse remodeling.     Ischemia (lack of oxygen) and infarction (cell damage) lead to increased interleukin-1 (IL-1)     production in the heart. IL-1 plays a critical role in adverse cardiac remodeling by     coordinating the inflammatory pathway (leading to wound healing) and apoptotic pathway     (leading to cell death).      In opposition to IL-1 activity, the human body produces a natural IL-1 receptor antagonist     that blocks the effects of IL-1. The drug form of this IL-1 receptor antagonist (anakinra) is     currently FDA approved for the treatment of rheumatoid arthritis, an inflammatory disease     characterized by excessive IL-1 activity. Experimental studies show that anakinra is able to     prevent cardiac remodeling and improve survival in mice after AMI.      We hypothesize that anakinra will show similar benefits in human patients by preventing     adverse remodeling and heart failure after AMI.   "
224927|NCT00789737|"     The current study investigates Welchol as monotherapy to improve glycemic control in subjects     with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The     study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well     tolerated and efficacious.   "
224928|NCT00789750|"     The current study investigates colesevelam as add-on therapy to pioglitazone to improve     glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with     pioglitazone monotherapy or pioglitazone in combination with either metformin or a     sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type     2 diabetes mellitus will be safe, well tolerated, and efficacious.   "
225346|NCT00801970|"     The purpose of this study is twofold:        -  to understand the etiology and the essence of fear of childbirth        -  to examine the implications and efficiency of several forms of psychological therapy.   "
224929|NCT00789763|"     Phase I: Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR)     of Sorafenib in combination with Gemcitabine and Radiotherapy      Phase II: Activity profile evaluating Progression-free rates (PFR) at 6 months, Response     rate, Overall survival, Toxicity profile   "
224930|NCT00789776|"     This phase I/II trial studies the side effects and best dose of donor natural killer (NK)     cell therapy and to see how well it works when given together with fludarabine phosphate,     cyclophosphamide, total-body irradiation, donor bone marrow transplant, mycophenolate     mofetil, and tacrolimus in treating patients with hematologic cancer. Giving chemotherapy,     such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor     bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. Giving an infusion of the donor's T cells     (donor lymphocyte infusion) may help the patient's immune system see any remaining cancer     cells as not belonging in the patient's body and destroy them (called graft-versus-tumor     effect). Sometimes the transplanted cells from a donor can make an immune response against     the body's normal cells. Giving mycophenolate mofetil and tacrolimus after the transplant may     stop this from happening.   "
224931|NCT00789789|"     This cohort study should provide an exhaustive overview on long-term safety of various     preventive HIV-vaccines administered in phase I and II clinical trials to healthy volunteers     of the ANRS network.   "
224932|NCT00789802|"     We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the     number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel     intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo.     The objective of this study is to compare the total number of days of bleeding experienced by     first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared to     those randomized to placebo for the first 12 weeks of use. We will enroll women initiating     LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo. We will     enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for 16 weeks     which will be used to calculate the total number of bleeding or spotting days. Statistical     analysis will be performed to evaluate if there is less bleeding among the treatment arms     then the placebo arm.   "
224933|NCT00789815|"     With the advances of flexible bronchoscopy, like metallic stent, electrocautery and real time     endobronchial ultrasound, the complexity and duration of procedures are increasing. So,     adequate sedation and analgesia is important for both patients and bronchoscopist.      Clinical-judged midazolam administration is the current standard. However, midazolam is     difficult to titrated and the clinical observations are not reliable sedative indices.     Propofol is titrated easily because of its unique pharmacokinetics. Bispectral index (BIS), a     real time monitor of depth-of-sedation, has been applied in general anesthesia.      We design a BIS-guided propofol sedation for bronchoscopy. Through the combination of     advantages of propofol and BIS, we hope to provide patients a more tolerable and safety     sedation for bronchoscopy.   "
224934|NCT00789828|"     This study evaluated the efficacy and safety of Everolimus in treating patients with     Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.   "
224935|NCT00789841|"     We will study the total gastrointestinal transit time (GITT), gastric emptying and small     intestine motility in NET patients before and after treated with somatostatin analogues and     compare these to healthy subjects. For this we will use radio-opaque markers and the newly     developed Motility Tracking System (MTS).      Hypothesis: Patients with NET and carcinoid syndrome have decreased GITT, gastric emptying     and small bowel transit time and an increase in phase III MMC activity compared to healthy     subjects. Treatment with somatostatin analogues increase transit times and decrease phase III     MMC activity and improves the clinical symptoms.   "
225174|NCT00793429|"     In this study healthy volunteers received increasing doses of prucalopride to study the     tolerability and cardiac safety of prucalopride. The study hypothesis was that prucalopride     at doses up to 10 mg has no clinically relevant effect on the cardiovascular safety in     healthy volunteers.   "
224936|NCT00789854|"     The primary objective of the study is to evaluate the efficacy of Quetiapine extended release     (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine     versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine     versus Quetiapine extended release monotherapy in subjects with treatment resistant     depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg     Depression Rating Scale (MADRS) total score. As an independent objective, the primary     objective will also be evaluated in two subgroups of patients: (1) patients who were     resistant to two previous antidepressant therapies and (2) in the subgroup of patients with     one previous failure.   "
224937|NCT00789867|"     The study objectives are to assess safety, tolerability and gene expression after a single     dose of non-viral CFTR gene therapy (pGM169/GL67A) administered to the nose and lungs of     patients with cystic fibrosis.   "
224938|NCT00789880|"     This study will examine whether administration of oral Vitamin D3 given over 21 days will     change the antimicrobial peptide expression in the skin or saliva of subjects with Atopic     Dermatitis (AD). This study will help researchers determine if the lack of the expression of     antimicrobial peptides in individuals with AD plays a role in the susceptibility to eczema     vaccinatum (EV).   "
224939|NCT00789893|"     Patient will have radiation to treat the cancer. This treatment can make the vagina both     narrower and shorter. That can cause two problems. It can make it harder for the doctor to do     a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable.      We tell women to use a vaginal dilator after radiation to the pelvis. This is standard     education. We do not routinely ask women how they do with it. We are doing this study to see     if using the dilator as we instruct will help the vagina stretch. The patient will have an     examine of the vagina before the start of radiation. We will see what size dilator can fit.     The goal of this study is to have the patient be able to use that size dilator within six     months after radiation.   "
225242|NCT00800592|"     The objective of this study is to assess the safety, tolerability and pharmacokinetics of     intravenous sildenafil (10 mg) administered as a bolus injection to patients with Pulmonary     Arterial Hypertension already receiving and stable on oral Revatio 20 mg TID.   "
224940|NCT00789906|"     Schizophrenia affects cognition, emotion, and behavior. Neuropsychological assessment enables     a better understanding of antipsychotic effectiveness and the brain processes, underlying     cognitive functioning in schizophrenia.      Neurocognitive deficits in schizophrenia patients appears to explain up to 61% of the     variance of functional outcome and is an important predictor of social reintegration     (Peuskens et al, 2005) and independent living activitiy (Green et al, 2004). Impaired social     functioning within schizophrenia population has been associated with increased health-care     costs. Since social and occupational disability may generate the largest indirect costs of     the illness, treatment of cognitive deficits has an enormous impact on the cost and     disability associated with schizophrenia (McGurk and Mueser, 2004).      However, the gap between cognitive science and clinical practice limits the implementation of     cognitive assessment in the routine evaluation of schizophrenia patients. Pharmaceutical     industry initiated numerous large scale, multisite studies on the impact of novel     antipsychotics on cognitive deficits in schizophrenia patients.      The aim of this research is to develop population norms of the computerized     neuropsychological assessment for effectiveness of the antipsychotic treatment in     schizophrenia.   "
224941|NCT00789919|"     Preeclampsia with new-onset hypertension and proteinuria is a pregnancy-specific disease that     affects 5-7% of gestations usually after the 20th week. Most cases are mild, but severe cases     exhibit multiple abnormalities in blood and maternal organ systems. Severe forms of     preeclampsia/eclampsia are a major contributor to maternal death in the world. Delivery stops     disease progression and recovery can begin. Patients with mild preeclampsia between 34-38     weeks' gestation usually are hospitalized for evaluation and close monitoring of signs,     symptoms, and certain laboratory studies as reflectors of disease status. As inpatients     mothers are monitored frequently for evidence of maternal or fetal compromise until 38 weeks     gestation when delivery is accomplished. If a patient with mild preeclampsia labors after 34     weeks, no attempt is made to stop labor and delivery is undertaken. It remains unclear when     during the third trimester that delivery should be accomplished for maximal maternal safety     and minimal fetal risk. In this research project, we will identify patients who are at least     34 weeks pregnant with mild preeclampsia. After informed consent to participate in the trial,     we will randomize participants to either be delivered immediately or treated with observation     and maternal-fetal surveillance in hospital as described previously with delivery at 38     weeks. There will be 110 participants enrolled in each arm of the study for a total of 220     patients who will be managed in the Wiser Hospital. We intend to analyze a number of maternal     and fetal outcomes including cost comparisons for the care of both mother and fetus in the     two groups of randomized patients. The findings should impact care of the pregnant patient     with mild preeclampsia in the third trimester with regard to how early and how late in     gestation that delivery should be accomplished for optimal maternal and perinatal benefit.   "
224942|NCT00789932|"     This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT)     program for treating core autism symptoms, social and emotional problems, and adaptive     behavior deficits in children with autism spectrum disorders.   "
224943|NCT00789945|"     The inclusion of Timing of premeal insulin administration (Timing) in an Intensive Insulin     Therapy regimen will reduce A1C by an average of 1% in type 1 diabetic patients who have     initial A1C's between 7.0% and 9.0%.   "
224944|NCT00789958|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     Specialized radiation therapy that delivers a high dose of radiation directly to the tumor     may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug     (combination chemotherapy) together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving capecitabine together with     gemcitabine followed by capecitabine and radiation therapy works in treating patients with     cholangiocarcinoma of the gallbladder or bile duct.   "
224945|NCT00789971|"     Cataract extraction is one of the most common operative procedures performed throughout the     world. Conventionally, patients are discharged with postoperative drops of steroids and     antibiotics or a combination of both. These drops are to be administered for 2-6 weeks     depending on individual eye unit protocol. Many patients find the postoperative drops arduous     and non-compliance can cause prolonged inflammation and discomfort. Patients with cognitive,     physical and visual impairments require assistance from family or community nurses to     administer drops. A single perioperative injection of Triamcinolone has been shown to be an     effective replacement for drops postoperatively in two previous studies 1, 2.      Aims & objectives      The aim of this study is to see if a single orbital floor injection of Triamcinolone is     equivalent to conventional steroid and antibiotic drops used post operatively in uneventful     phacoemulsification surgery in treating postoperative inflammation.   "
224948|NCT00790010|"     The purpose of this research study is to determine the safety of using the study drugs     bevacizumab and ipilimumab together, and the doses in combination which can be given to     people safely. This study also seeks to investigate whether using both study drugs lengthens     the amount of time before the participants melanoma worsens.   "
224949|NCT00790023|"     To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg)     once daily compared to placebo in subjects with SAR.   "
224950|NCT00790036|"     Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell     Lymphoma (DLBCL) of RAD001 versus matching placebo after patients had achieved complete     response with first-line rituximab-chemotherapy   "
224951|NCT00790049|"     This is a Phase 1 study, involving both 1-day and 8-day dosing periods, designed to test the     safety of investigational study drug ARRY-371797 in healthy subjects. Approximately 48     healthy subjects from the US will be enrolled in this study.   "
224952|NCT00790062|"     This is a double-blind 3-arm randomized clinical trial to determine whether higher dose     oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony     and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the     uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of     maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and     effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not     known.   "
224953|NCT00790075|"     The goal of this study is to demonstrate safety and efficacy of liquid risperidone in     psychiatrically hospitalized children, ages 4-12, who would be put in seclusion or restraint,     or given an intramuscular injection of diphenhydramine because of their out-of-control     behavior if not medicated with risperidone. The first part of the study will: 1) develop     appropriate oral doses of medication to reduce out of control or agitated behavior     effectively with the fewest side effects, and 2) develop a rating system to measure the     children's behavior i.e. level of improvement, sedation, and untoward effects.   "
224954|NCT00790088|"     The aim of the project is to document the international routine practice in sensor usage in     patients treated with sensor-augmented pump therapy and to assess which variables (e.g.     training of patients, frequency of sensor usage etc) are associated with an improvement in     clinical outcome(s) from the start of the sensor use to the end of the follow-up period.   "
224955|NCT00790101|"     This is a multi-center, randomized, double-blind, double-dummy study designed to compare the     effects of risedronate, raloxifene, and placebo on BMD, bone turnover markers, and other     markers of anabolic activity in postmenopausal women who previously received HRT.   "
224956|NCT00790114|"     To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a     CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine     and its paraxanthine [3-desmethyl] metabolite).   "
224957|NCT00790127|"     The purpose of this study is to evaluate the safety and tolerability of HQK-1001 administered     daily for 8 weeks in subjects with beta thalassemia intermedia   "
224958|NCT00790140|"     This study aims to examine whether providing tube feeding with a formula enriched with     omega-3 fats is better than traditional standard tube feeding in terms of preserving     nutritional status, improving immune function and reducing medical complications following     major upper Gut cancer surgery.   "
224959|NCT00790153|"     To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656     suspension.   "
224960|NCT00790166|"     That the level of humidification delivered to patients during CPAP treatment will alter the     subjects mucociliary clearance rate and related mucus properties.   "
224961|NCT00790179|"     Continuous lumbar plexus and femoral blocks have been demonstrated to provide effective     postoperative analgesia of the lower extremity following total joint arthroplasty. The     purpose of this study was to compare these two techniques when used with intravenous     patient-controlled analgesia and the use of patient-controlled analgesia alone for     postoperative pain management following unilateral total hip arthroplasty.   "
224962|NCT00790192|"     Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This     clinical study is designed to test the hypothesis that lurasidone is effective, tolerable,     and safe as compared with quetiapine XR short term among acutely psychotic patients with     chronic schizophrenia.   "
224963|NCT00790205|"     This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment     with sitagliptin used as part of usual care compared to usual care without sitagliptin in     participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV)     disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.      Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to     usual care without sitagliptin with regard to the risk of developing a confirmed event in the     primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If     hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care,     is superior to usual care without sitagliptin with regard to the risk of developing a     confirmed event in the primary CV composite endpoint.   "
224964|NCT00790218|"     This trial will test the safety and efficacy of CF102 in patients with advanced liver cancer.     Successive groups of patients will be given higher doses of CF102 by mouth on a twice-daily     basis. Treatment will be assessed for adverse effects and for effects on the tumor.   "
224979|NCT00790413|"     Children with primary resistant or relapsed neuroblastoma who do not achieve remission with     conventional chemotherapy have extremely dismal prognosis. A novel treatment strategy     combining tumor targeted radioisotope treatment with metaiodobenzylguanidine (MIBG) and     immunotherapeutic effect of haploidentical stem cell transplantation (haploSCT) followed by     low-dose donor lymphocyte infusions will be piloted. The use of the isotope is aimed to     decrease pre-transplant tumour burden. Reduced intensity conditioning containing Fludarabine,     Thiotepa and Melfalan will enable sustained engraftment as well as will serve as additional     anti-tumor treatment. A prompt natural killer (NK)-cell mediated tumour control may be     achieved by haploidentical stem cell transplantation. The investigators hypothesize that     tumour cells potentially evading NK-cell mediated immunity may be targeted by infused donor     T-cells and eliminated by either MHC-dependent manner or through a bystander effect. The     possible graft versus tumor effect will be evaluated in children with therapy resistant     neuroblastoma.   "
224965|NCT00790231|"     Acute urinary retention is one of the most common complications after surgery and anesthesia.     Overfilling the bladder can stretch and damage the detrusor muscle, leading to atony of the     bladder. It can occur in patients of both sexes and all age groups and after all types of     surgical procedures. Micturition depends on coordinated actions between the detrusor muscle     and the external urethral sphincter. Motorneurons of both muscles are located in the sacral     spinal cord and coordination between then occurs in the pontine tegmentum of the caudal brain     stem. Motorneurons innervating the external urethral sphincter are located in the nucleus of     Onuf, extending from the S1 to the S3 segment. The smooth detrusor muscle is inner-vated by     parasympathetic fibers, which reside in the sacral intermediolateral cell group and are     located in S2-4. Sympathetic fibers innervating the bladder and urethra play an important     role in promoting conti-nence and are located in the intermediolateral cell group of the     lumbar cord (L1-L4). Most afferent fibers from the bladder enter the sacral cord through the     pelvic nerve at segments L4-S2 and the majority are thin myelinated or unmyelinated. Because     peridural anesthesia can be performed at various levels of the spinal cord and with varying     concentrations of local anesthetic, it is possible to block only a portion of the spinal cord     (segmental blockade). So it seems logical that peridural analgesia from a Th 2-4 to Th 10-12     will have no influence on the micturition reflex. Studies on the urodynamic effects of     various anaesthetic agents are rare. Under the influence of epidural analgesia, patients may     not feel the urge to urinate, which may result in urinary retention and bladder over     distension. Spinal and epidural opioid administrations influence the function of the lower     urinary tract by direct spinal action on the sacral nociceptive neurons and autonomic fibres.     It is therefore a common practice for bladder catheterisation in the presence of spinal or     epidural anesthesia. The excessive use of a transurethral catheter is undoubtedly associated     with significant morbidity such patient discomfort, urinary tract infections, catheter     entrapment, bladder calculi formation, urethral trauma and stricture. The risk of infection     with a single catheterization is 1-2% and can rise to 3 to 7 % a day. There has yet been no     consensus for appropriate catheterisation strategy and urodynamic changes under thoracic     epidural anesthesia are still unknown. We expect that a better knowledge on the bladder     function under epidural analgesia could lead to a more restrictive use of perioperative     transurethral catheters. Our hypothesis is that thoracic epidural analgesia does not     influence lower urinary tract function in the male and female. Therefore transurethral     catheterization is not mandatory for all patients with thoracic epidural analgesia.     Differences in post void residual urine volume and urodynamic examinations before and during     thoracic epidural analgesia will be analyzed in 16 men and 16 women undergoing open kidney     surgery/lumbotomy who receive thoracic epidural anesthesia perioperatively.   "
224966|NCT00790244|"     SSG XX is a phase II trial for high-risk soft tissue sarcomas (STS) of the extremities and     trunk wall. Prognostic factors (histopathological markers) are used to identify high-risk     tumors. SSG XX will evaluate chemo- and radiotherapy given adjuvantly to these patients. In a     specified group of patients also preoperatively given therapy will be studied.   "
225379|NCT00802399|"     The purpose of this study is to describe a case series of patients with chronic dry eye     submitted to partial punctual occlusion.   "
224967|NCT00790257|"     In view to avoid immunosuppression, the investigators are submitting a Phase 1 clinical trial     protocol testing the safety and the efficacy of encapsulated human islets in a Monolayer     Cellular Device for allogeneic islets transplantation in Type 1 diabetic patients performed     at the University clinical hospital Saint-Luc, Brussels. Encapsulated human islets will be     transplanted in the subcutaneous tissue as safety procedure for patients.      This protocol (single center trial) is designed as a limited series of islets transplants for     15 Type 1 diabetic adult subjects.   "
224968|NCT00790270|"     The purpose of this study is to see whether the combination of a muscle relaxant and     anti-inflammatory drug is more effective at relieving pain in patients with neck strains or     whiplash than either of the two medications alone.   "
224969|NCT00790283|"     The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of     the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native     coronary arteries and compare it to the VISION/MINIVISION coronary stent   "
224970|NCT00790296|"     The primary objective of the study is to evaluate thyrotropin releasing hormone (TRH) as a     treatment for cancer-related fatigue.      The central hypothesis of this pilot study is that TRH is more efficacious than placebo in     alleviating cancer-related fatigue in patients with breast or prostate cancer.   "
224971|NCT00790309|"     The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very     short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical     Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as     to compare these changes to diet-induced changes in the same population.   "
224972|NCT00790322|"     The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral     mucositis in head and neck cancer patients undergoing radiation therapy.   "
224973|NCT00790335|"     The purpose of this study is to determine if the use of adjunctive Pharmacomechanical     Catheter Directed Thrombolysis, which includes the intrathrombus administration of     rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with     symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy     alone.   "
224974|NCT00790348|"     The purpose of this study is to see the effect of Januvia on Ghrelin levels in patients with     diabetes.   "
224975|NCT00790361|"     Traumatic spinal cord injury is a common injury to the spine and can lead to a clinical     syndrome called central cord syndrome (CCS). CCS is an incomplete spinal cord injury where     one starts to lose more motor function in the upper rather than lower extremities. It affects     a wide range of the population from the young to the old. However, the natural history of CCS     is poorly understood.      Research has shown that the injury resulting in CCS might be due to the pinching or     compressing of the spinal cord. This creates damage to a part of the spinal cord and creates     difficulties in the signal getting through. We believe that we can gain a better     understanding of the natural history of incomplete spinal cord injury as well as the recovery     process.      It is possible to track many changes in the brain and motor function through a variety of     methods. One can track the concentrations of different chemicals (metabolites) by using     magnetic resonance spectroscopy (MRS), changes in brain activation by using functional     magnetic resonance imaging (fMRI) and thread-like nerve fibers in the spine by using     diffusion tensor imaging (DTI). In our study we will be detecting differences in brain     metabolism and activation of different parts of the brain during specific movement and in the     nerve fibers in the brain.      We hypothesize that there will be decreased levels of N-acetylaspartate (NAA, a putative     marker of neuronal function) and decreased levels of glutamate (the primary excitatory     neurotransmitter) in the motor cortex in patients with CCS when compared with controls. Over     time, we hypothesize that the normalization of metabolite levels will correlate with the     extent of neurologic recovery. We also hypothesize a reorganization of brain activation     patterns with time such that patients will show increased volumes of activation in the motor     cortex with recovery and that this will correlate with the extent of neurologic outcome. Over     time, we predict that there will be normalization of the fibre track anatomy that will     correlate with neurological recovery.   "
224976|NCT00790374|"     The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in     patients with prostate cancer with disease progression while on androgen ablative therapy   "
224977|NCT00790387|"     Patients undergoing coronary angioplasty are frequently treated with new drugs that stop     blood platelets working and so improve the success of the procedure. Individual patients may     vary in the dose of the drug required. New platelet tests have been developed which can be     performed near the patient and possibly immediately tell the doctor the degree of platelet     inhibition achieved so that the dose can be adjusted accordingly. This study aims to     investigate if these platelet tests indicate if new anticoagulants are more effective at     inhibiting platelet function than the traditional anticoagulants. The study will demonstrate     if these newer drugs improve blood flow through the heart muscle and thereby provide better     long term outcomes for patients undergoing percutaneous intervention.   "
224980|NCT00790426|"     This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer   "
224981|NCT00790439|"     Type 1 diabetes mellitus (T1D) is an autoimmune disease in which the insulin-producing     pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of     this study is to assess the safety and effectiveness of low molecular weight sulfated dextran     (LMW-SD) on post-transplant islet function in people with T1D who have responded to intensive     insulin therapy and have received kidney transplants. This study is taking place in Uppsala     and Stockholm, Sweden, and Oslo, Norway.   "
224982|NCT00790452|"     Primary objective:      To determine whether aspirin (ASA) can lower the incidence of Venous Thromboembolism(VTE) in     patients with Glioblastoma (GBM).      Secondary objectives:      To determine clinical and laboratory factors which are associated with increased risk of VTE      If it is determined that ASA reduces the incidence of VTE in patients with GBM, then to     determine the clinical and laboratory factors which are associated with an increased benefit     from the drug.   "
224983|NCT00790465|"     Flavanols, present in dark chocolate, were shown to induce Nitric Oxide synthesis. Since     Nitric Oxide facilitates smooth muscle relaxation, it might ease the relaxation of the LES     (lower esophageal sphincter)as well.      The objective of the present study is to evaluate tha efficacy of dark chocolate in improving     LES relaxation in achalasia patients.   "
224995|NCT00790634|"     The purpose of this study is to characterize and compare irregularities in dopaminergic     function in fronto-subcortical circuits, between Parkinson's Disease patients (ON and OFF     medication) and patients with obsessive-compulsive disorder, by examining performance on     cognitive tasks involving cognitive flexibility, decision-making, and attentional bias.   "
225069|NCT00792025|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying sunitinib to see how well it works as second-line     therapy in treating patients with locally advanced or metastatic transitional cell cancer.   "
224984|NCT00790478|"     Ulcerative colitis is an inflammatory bowel disease that afflicts up to one million people in     the U.S. Symptoms include rectal urgency, bloody diarrhea, moderate to severe abdominal pain,     fever, and fatigue. Melatonin is a hormone that is associated with sleep and other body     functions that may be related to health. Melatonin is produced in the pineal gland and, in     fact, it is produced in even greater amounts in the gut. Melatonin appears to be important in     gastrointestinal tract physiology and health, and data from cell and animal experiments, and     some studies in humans, suggest that supplemental melatonin may help ameliorate colitis.     Given that current treatments for ulcerative colitis are not always effective, and often have     serious side effects, there is considerable interest in finding alternative treatments for     this disease. However, experimental data on the ability of melatonin to improve ulcerative     colitis in humans are lacking. To address this, we plan to conduct a pilot clinical trial (60     adult male and female participants) that will obtain preliminary data about the effectiveness     of melatonin supplementation as a treatment for ulcerative colitis in adult men and women     with the disease.      The Melatonin and Ulcerative Colitis study funded by a grant from the Broad Foundation's     Broad Medical Research Program (http://www.broadmedical.org).   "
224985|NCT00790491|"     ABSTRACT Although most primary healthcare practitioners recognize the important relationship     among nutrition, physical activity and health, few incorporate either dietary or physical     activity counseling into routine practice. AUGMENT will employ interactive technology to     support effective patient life-style counseling during routine office visits. AUGMENT     technology will automate the administration, collection, and analysis of dietary and physical     activity questionnaires, and it will guide counseling and present intervention resources and     strategies tailored to the patient's unique needs. Using tablet computers, wireless LANs, and     inexpensive Internet communications, AUGMENT will have advantages over existing tools: 1.)     Lower usage costs (minimal office personal required), 2.) Ability to customize the system,     and 3.) Real-time, comprehensive assessment.      The AUGMENT system efficiently and relentlessly gathers important healthcare information     (such as total fat, type of fat consumption; fruit and vegetable consumption; fiber and     micronutrient intake; and energy output). This means patients are less likely to have their     preventive needs overlooked by a busy practitioner. The assessment includes questions to     determine the amount of effort the patient will commit to improved health. This will enable     the physician to effectively guide the patient via targeted recommendations, obtainable     goals, and a course of action that is both preventive and prescriptive; and to monitor     progress. Patients who receive objective assessments of their healthcare practices and     recommendations based on their own unique health history will be more likely to accept and     act on the recommendations.      The specific aims of the study are to: 1) Incorporate key elements of a previously developed     prototype tool into a dietary and physical activity risk assessment system, 2) Create a     provider training tool to build proficiency in using AUGMENT for counseling to reduce disease     risk.      3) Validate the AUGMENT dietary and physical activity assessments using dietary recalls and     accelerometer data, 4) Complete a process evaluation of the AUGMENT program by using it in     interventions managed by six physicians with at least 240 patients, and 5) Survey     participating providers and patients to assess acceptability of AUGMENT within a clinical     setting.   "
224986|NCT00790504|"     This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets     etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery     mode, by using transperineal ultrasound. This will be compared with pregnancies with single     fetuses.   "
224987|NCT00790517|"     The purpose of this study is to examine the effectiveness of a lifestyle intervention     designed to reduce weight and diabetes risk in a population of individuals with mental     illness who are also taking antipsychotic medications. We will examine the effectiveness of     the intervention in        1. reducing weight and Body Mass Index;        2. reducing fasting insulin levels and increasing insulin sensitivity; and        3. reducing total cholesterol and LDL cholesterol.   "
224988|NCT00790530|"     The purpose of this study is to evaluate the effectiveness of automated telephone outreach     with speech recognition to improve diabetes care.   "
224989|NCT00790543|"     The purpose of this study for children with a new diagnosis of Crohn's disease is to identify     biomarkers found in the blood or stool to help predict which children are at risk of     developing complications.   "
224990|NCT00790556|"     A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of     MK8245.   "
224991|NCT00790569|"     RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is     not yet known whether varenicline is more effective than the nicotine patch given together     with nicotine gum in helping smokers quit smoking.      PURPOSE: This randomized clinical trial is studying varenicline to see how well it works     compared with the nicotine patch given together with nicotine gum in helping smokers in a     methadone treatment program stop smoking.   "
224992|NCT00790582|"     This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is     to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the     progression of the disease. Since there is no placebo in this study, all patients will be     taking lithium carbonate.   "
225042|NCT00791674|"     Lay title: A study of breathing pauses during sleep in patients on long term opiates.      Sleep apnoea is a term which refers to frequent breathing pauses during sleep. Breathing can     stop at night due to the upper airway collapsing (Obstructive sleep apnoea)or reduced signals     from the brain driving breathing (central sleep apnoea). Clinical observation has noticed     that patients on opiates have an increase in sleep apnoea.      Hypothesis: This study looks at the relationship of opiates (when used for patients chronic     pain) and the occurrence of sleep apnoea. It is expected that there will be an increase in     sleep apnoea (particularly of the central variant) particularly in patients on long term     opiates.   "
224993|NCT00790595|"     Prostate cancer is prevalent in the United States, with approximately 230,110 new cases and     29,900 deaths in 2004. Approximately 30% of new cases will be clinical stage T3 when they are     diagnosed. This is a stage in which there is high probability that the cancer has spread     beyond the prostate gland itself, making it much more difficult to treat. In these cases,     when surgery is done by itself and the prostate is removed, it is still very likely that some     cancer that has spread beyond the prostate remains and will get worse. Radiation applied to     the prostate also does not work well on tumors that have spread beyond the prostate. Even     surgery and radiation combined have not eliminated the problems caused by prostate cancer     that has spread into the tissue outside the prostate itself.      New treatments are needed to deal with prostate cancer at this more serious stage. Study     doctors believe that it might be possible to shrink the prostate cancer using a new drug     called SUO11248 or Sunitinib. After the patients take the drug, study doctors believe the     cancer will shrink back to within the prostate, and they can then surgically remove the     prostate and all the cancer. Patients on this study also will be given increasing doses of     Sunitinib to find out how much of the drug can be given safely.   "
224994|NCT00790608|"     The purpose of the study is to determine if topically applied nitric oxide gas is effective     in reducing the quantity of bacteria (including MRSA)in a wound.   "
224996|NCT00790647|"     RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the     growth of abnormal cells by stopping them from dividing or killing them. Giving     colony-stimulating factors and certain chemotherapy drugs, helps stem cells move from the     bone marrow to the blood so they can be collected and stored. Chemotherapy and monoclonal     antibody therapy is then given to prepare the bone marrow for the stem cell transplant. The     stem cells are then returned to the patient to replace the blood-forming cells that were     destroyed by the chemotherapy.      PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib     followed by stem cell transplant works in treating patients with primary systemic     amyloidosis.   "
224997|NCT00790660|"     This study is intended to assess safety and tolerability of ASP1941 compared to placebo in     adult subjects with type 2 diabetes mellitus   "
224998|NCT00790673|"     This trial will test the hypothesis that CF102 can safely and effectively suppress viral load     in patients with chronic hepatitis C and high circulating levels of virus. The trial will     monitor the safety of twice-daily oral dosing with CF102 over a 16-week period; will measure     changes in viral load during therapy; and will measure blood concentrations of CF102 at     various time points during dosing.   "
224999|NCT00790686|"     TOTEME offers to treat certain chronic strictures of the ureter with MEMOKATH 051 to assess     its effectiveness, tolerance and mean durability during a 3 years follow up period.      Patients usually treated with double J stents will be included. The double J stent will be     replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. After this     procedure, the patients will have medical examinations, blood exams, radiography and renal     sonography during 3 years. If a problem of tolerance or effectiveness is diagnosed, the     ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent.   "
225000|NCT00790699|"     The purpose of this study is to determine whether injecting Symlin and insulin through a     multiple injection port is safe and effective. This will be measured by HbA1c values taken at     the beginning of the study and at the final visit.      The secondary objective of the study is to measure patient satisfaction toward using the     multiple injection port.   "
225001|NCT00790725|"     In this study, we want to compare two different kinds of artificial ventilation to see if one     encourages faster weaning from breathing support and if one provides better sleep quality.     These artificial ventilation types are:        1. Pressure support ventilation; the standard ventilation that we use for the patients in          the Respiratory Acute Care Unit. Pressure support ventilation ventilators use constant          air pressure to assist patients with their breathing.        2. Proportional assist ventilation; a newer way of helping people with their breathing. The          air pressure provided by proportional assist ventilation ventilators varies with the          size of the breath that a person takes.   "
225002|NCT00791141|"     This multicenter, open-label, uncontrolled phase II trial evaluates safety and efficacy of     post-operative chemoradiation in combination with cetuximab in squamous cell carcinoma of the     head and neck.   "
225003|NCT00791154|"     This trial is titled A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based     Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC).      Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to     identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus     cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.      Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm     investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with     platinum-based chemotherapy.   "
225004|NCT00791167|"     The purposes of this study are to evaluate the dose proportionality of 1.5- and 3 mg tablets     of paliperidone ER, to document the pharmacokinetics of a 1.5 mg dose of paliperidone ER, and     to assess the safety and tolerability of the 1.5- and 3 mg tablets in healthy men.   "
225005|NCT00791180|"     The primary purpose of this study is to track and document the clinical outcomes of patients     with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.     Secondary purpose of this study is to assess outcomes with historical controls along a     continuum of motion and anatomy sparing procedures.   "
225043|NCT00791687|"     Premature infants are highly susceptible to oxidative stress because of the immaturity of     their antioxidant defense system. The use of prenatal glucocorticosteroids administered to     the mother improves respiratory function and overall outcome. The investigators hypothesize     that prenatal glucocorticosteroids favor the expression and competence of the antioxidant     defense system.   "
233178|NCT00907673|"     A 28-week, feasibility study to investigate the safety and efficiency of the Automatic Fluid     Shunt in patients with chronic congestive heart failure, ascites and diuretic resistance.   "
225006|NCT00791193|"     The primary purpose of this study is to evaluate the pharmacokinetics and relative     bioavailability of paliperidone ER formulations with slow, target, and fast in vitro release     rates after administration of a single 12 mg dose. The slow and fast releasing ER tablets     have in vitro release rates outside the current commercial specifications. Therefore, in     order to support widening of the specification limits, this study will be performed. The     target formulation to be used is representative of the commercial formulation. Other     objectives of this study are 1) to compare the relative bioavailability of paliperidone ER     formulations with slow, target, and fast in vitro release rates to the paliperidone IR     formulation; 2) to explore the in vitro in vivo correlation (IVIVC) for the paliperidone ER     formulation; and 3) to evaluate the safety and tolerability of the different paliperidone ER     formulations.   "
225007|NCT00791206|"     Previously, the preconditioning signaling pathways have been studied on molecular level or in     animal model. By using MR spectroscopy and imaging in a dynamic human model of     preconditioning, we will have a better understanding how mitochondrial and endothelial     function are affected by preconditioning in-vivo.   "
225008|NCT00791219|"     The objective of this study is to compare the relative efficacy and safety of     SUBA™-Itraconazole Capsules (HalcyGen Ltd) to an already marketed oral formulation of     itraconazole SPORANOX® (itraconazole) capsules (Janssen Pharma) in the treatment of     onychomycosis of the toenail. Both the test and the reference formulations will also be     compared to a placebo formulation to test for superiority.   "
225070|NCT00792038|"     OCD patients are assessed before and after treatment using diagnostic tools, rating scales     neuropsychological assessment and functional and structural MR-scans.   "
225009|NCT00791232|"     The purpose of this study is a noninferiority comparison of the orthostatic tolerability of a     dose of 12 mg extended-release (ER) OROS paliperidone with the current recommended initial     titration dose (2 mg) of immediate-release (IR) risperidone in patients with schizophrenia.     Other study objectives are 1) to compare the tolerability and safety of a clinically     equivalent fixed dose of ER OROS paliperidone with the currently recommended dose of     risperidone, 2) to compare the early tolerability of the 2 treatments with placebo, 3) to     compare tolerability of the 2 treatments, using a population pharmacokinetic/pharmacodynamic     (pop PK/PD) model, to 4) assess the relationship between genetic variability in drug     metabolizing enzymes and interindividual variability in plasma exposure to paliperidone or     risperidone within each treatment group.   "
225010|NCT00791245|"     The purpose of this post market study is to evaluate surgical implantation technique and the     quality of repair of the cartilage defect with particulated juvenile cartilage in the human     knee joint.   "
225011|NCT00791258|"     The initial 12 week portion of this 20 week study will examine the ability of a combination     of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high     blood pressure who have not had sufficient blood pressure reduction using one     anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine     the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to     lower blood pressure in the same patient population. All three medications being tested have     been approved by the FDA for the treatment of high blood pressure, but only amlodipine and     olmesartan are currently approved for use in combination form.   "
225012|NCT00791271|"     The goal of the first phase of this clinical research study is to find the highest tolerable     dose of decitabine and peginterferon alfa-2b that can be given in combination to patients     with melanoma. The safety of this drug combination will also be studied.      The goals of the second phase are to learn if decitabine and peginterferon alfa-2b combined     can help to control melanoma, and to find out which doses are more effective and/or better     tolerated.   "
225013|NCT00791284|"     The purpose of this study is 1) to investigate the single-dose pharmacokinetics of immediate     release (IR) paliperidone, after oral administration, in patients having moderate hepatic     impairment compared to patients having normal hepatic function, 2) to document the plasma     protein binding and disposition of the enantiomers of paliperidone, and 3) to evaluate the     tolerability and safety profile of IR paliperidone in both patient populations.   "
225014|NCT00791297|"     The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring     delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on:        1. follicular function and inhibition of ovulation        2. the endometrium        3. bleeding patterns; and also to assess safety including effects on the endometrium   "
225015|NCT00791310|"     The objective of this pilot study is to estimate a procedure where the biological samples     routinely obtained at the site of suspected infection could be guided by the early     realization of a TEP with FDG coupled to scanner X, in patients hospitalized in ICU for     severe sepsis of unspecified etiology.   "
225016|NCT00791323|"     A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac     0.04% following peripheral iridotomy   "
225017|NCT00791336|"     This study combines nelfinavir (NFV) with radiation therapy and chemotherapy as a treatment     for non-small cell lung cancer (NSCLC) who are considered candidates for pre-operative     treatment.   "
225018|NCT00791349|"     The purpose of this study is to assess the cardiovascular safety of paliperidone in patients     with schizophrenia or schizoaffective disorder, with particular attention to the length of     the QT/QTc interval, to measure and review other electrocardiogram (ECG) parameters, such as     QRS and PR intervals, to explore the relationship between the pharmacokinetics of     paliperidone and ECG parameters of interest, and to explore the safety and tolerability of     paliperidone   "
225044|NCT00791700|"     The primary purpose of this study is to determine the pharmacokinetic properties (what the     body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1     infected children and adolescents. This study will also determine whether maraviroc is safe     to use in children and adolescents.   "
225045|NCT00791713|"     The purpose of this study is to evaluate the effects of a CYP2D6 inhibitor, paroxetine, on     the pharmacokinetics of a single dose of orally administered paliperidone ER and to evaluate     the safety and tolerability of both treatments in healthy men   "
225046|NCT00791726|"     In uveitic patients with fluorescein angiographically proven macular edema, a fundus related     microperimetry is performed and results are correlated with foveal thickness as measured with     optical coherence tomography (OCT).   "
226069|NCT00813020|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate whether     differences exist between three different concentrations of the drug, NN9535, administered in     healthy male subjects in equal doses.   "
225019|NCT00791362|"     Objective: This study aims to determine the effectiveness and efficiency of a national     accreditation and improvement programme for general practice, focusing on patients with     established cardiovascular diseases.      Design: Cluster randomised trial with a block design. All practices start with the     accreditation procedure.Intervention group practices are requested to focus their improvement     plans in the first year on cardiovascular disease. Control group practices are requested to     focus their improvement plans in the first year on other domains. Measurements at baseline     are based on the standard audit in the accreditation procedure. Follow-up measurements are     done 12 months after approval of improvement plans.      Participants: Primary care physicians in The Netherlands.      Interventions to be implemented: improvement plans concerning cardiovascular risk management,     as described by recently updated national multidisciplinary evidence-based NHG / CBO     guidelines, considering patients with established cardiovascular diseases.      Implementation strategy: The national programme for accreditation and improvement of general     practice. This procedure consists of a package of activities, including audit, feedback,     improvement plans, and follow-up.      Outcome measures: Primary outcomes are percentages of patients with CVD who have acceptable     systolic blood pressure and cholesterol levels (quantified according to the indicators in the     accreditation)and who use aspirin or alternatives. Secondary measures include clinical and     organisational indicators of quality of cardiovascular care, such as percentages of patients     with cardiovascular disease whose risk factors were assessed and who received specific     medication.      Economic evaluation: Incremental cost effectiveness ratio's are determined of the     implementation strategy compared to no implementation. The analysis will take a societal     perspective and a time horizon of the observed period as well as a hypothetical 10 years     period (using modelling). Uncertainty related to the estimations is examined with sensitivity     analyses and bootstrapping. The long term economic evaluation is based on Markov modelling.   "
225089|NCT00792285|"     This large randomized controlled trial is testing the effectiveness of automated telephone     outreach with speech recognition to improve rates of screening for colorectal cancer. The     hypothesis is that the intervention improves rates of screening overall and specifically     rates of colonoscopy.   "
225020|NCT00791375|"     The goal of this study is to adapt a previously developed web-based physical activity     intervention so that the intervention targets young adult cancer survivors(age 18 to 39). The     web-based intervention will then be pilot tested to determine whether it is feasible for and     acceptable to young adult cancer survivors; we hypothesize that the intervention will be both     feasible and acceptable. Preliminary data on the effects of the intervention on physical     activity level, mood and fatigue will also be collected.   "
225021|NCT00791388|"     This study is a multiple ascending dose study to Assess the Safety, Tolerability, and     Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and     Female Volunteers for 14 Days (27 Doses).   "
225022|NCT00791401|"     The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of 3 mg     extended release paliperidone (ER OROSÃ' paliperidone) in patients with varying degrees of     renal impairment (mild, moderate, and severe), compared to patients with normal renal     function. Secondary objectives include the assessing the disposition of the (+) and (-)     enantiomers by means of an enantioselective liquid chromatography mass spectrometry assay, to     determine plasma protein binding of the enantiomers in patients with impaired renal function,     compared with patients with normal renal function, and to evaluate the tolerability and     safety profile of ER OROS paliperidone in patients with varying degrees of renal impairment     (mild, moderate, and severe) compared with patients with normal renal function.   "
225023|NCT00791427|"     This is an open-label study assessing electrophysiologic testing of the retina with     Electoretinogram (ERG) /Electrooculogram (EOG) tests in patients with exudative age-related     macular degeneration (AMD). The standard FDA-approved treatment for wet AMD is ranibizumab     (Lucentis). This study focuses on the ERG and EOG tests to evaluate retinal responses to     ranibizumab treatment in AMD.   "
225024|NCT00791440|"     This study examines the impact of Cognitive-Behavior Therapy (CBT) on symptoms, physiological     arousal, stressors, and the ways to deal with them in individuals with schizophrenia and     related disorders. The primary aim of this study is to investigate the role cognitive coping     strategies play in mediating the link between stress, physiological arousal, and psychotic     symptoms in individuals with schizophrenia during recovery from psychosis.   "
225025|NCT00791453|"     This study will involve established clinic patients. The Rapid Estimate of Adult Literacy in     Medicine will be administered during patients' regular clinic visits. Patients will then be     referred to the Consumer Health Education Center (CHEC)by healthcare providers who will fill     out a referral form. The form will be given the the CHEC health educator who will assist     patients in finding literacy-appropriate health information. BMI and Hgb A1c values will be     compared after 3 months and 6 months to baseline values. It is hypothesized that objective     assessment of patient use of literacy-appropriate, health information from the Clarksdale     Diabetes and Metabolism Clinic CHEC will improve Hgb A1c and BMI values among patients.   "
225026|NCT00791466|"     Rationale: In regions of severe endemic goiter, the adverse effects of in utero iodine     deficiency on neuromotor development are well established: randomized controlled trials of     iodine supplements given to iodine deficient mothers before pregnancy or during early     pregnancy improve motor and cognitive performance of their offspring. However, the potential     adverse effects of mild-to-moderate iodine deficiency during pregnancy are unclear.     Inadequate thyroid function in the fetus and newborn are the likely cause of brain damage in     iodine deficiency.      Objective: To determine whether the daily oral administration of 200 µg iodine to pregnant     women in areas of mild-to-moderate iodine deficiency improves maternal and newborn thyroid     function, pregnancy outcome, birth weight, infant growth and cognitive performance.      Study design: Double-blind randomized controlled multicentre trial. Study population:     Pregnant women (18-40 years) presenting at the clinic for their first prenatal visit will be     recruited at two research sites, namely St. Martha's hospital in Bangalore, India and     Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. At each site, 400 women will be     recruited.      Intervention: Half of the women will be randomized to iodine treatment (200 µg per day) and     the other half to placebo throughout pregnancy.      Main study parameters/endpoints: Differences between group means in indicators of thyroid     function, birth outcome, urinary iodine, breast milk iodine, infant growth, and psychomotor     development.   "
225027|NCT00791479|"     This is a study to demonstrate that different doses of once-weekly LY2189265 injected     subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in     participants with type 2 diabetes mellitus.   "
225028|NCT00791492|"     This study is designed to determine the long-term safety and tolerability of Fx-1006A as well     as the effects of Fx-1006A on clinical outcomes in patients with ATTR-PN.      All patients who enroll in this extension study will receive once-daily oral 20 mg Fx-1006A     for 12 months; therefore, patients randomized to placebo in Study Fx-005 will cross over to     active drug (Fx-1006A 20 mg) during this study. However, patients and their families as well     as clinical Investigators and their clinical site staff will remain blinded to the original     Fx-005 treatment assignment. It is intended that there will be no interruption in study     medication administration between the two studies. The majority of safety and clinical     outcomes assessments will be identical to those evaluated in Study Fx-005. Additional     assessments for this open-label extension study include 24-hour Holter monitoring and skin     biopsy for IENF; patients will be required to provide written informed consent to participate     in this open-label extension study prior to having these additional procedures performed.      The values obtained from procedures and evaluations conducted during the Month 18 visit of     Study Fx-005 will be used as the Baseline values for this open-label extension study. The     Baseline assessments of IENF and Holter monitoring may be conducted at either day of the     Month 18 visit days of Study Fx-005, but prior to the first Fx-1006A dose in this open-label     extension study. Clinic Visits will be conducted at Week 6 (± 2 days), and Month 3 (± 1     week), Month 6 (± 2 weeks), and Month 12 (± 2 weeks). Monthly telephone contacts (± 1 week of     the scheduled date) will be made during months in which no investigative site visits are     scheduled (Months 2, 4, 5, 7, 8, 9, 10, and 11) for assessment of adverse events and     concomitant medications.      Neurological evaluation by NIS-LL will be performed at Months 6 and 12. The NIS-LL will be     assessed by utilizing the average of two successive NIS-LL clinical assessment scores     obtained at least 24 hours apart within a one week period for each study visit. A dedicated     neurologist will be required to perform NIS-LL scoring across all time-points for each     individual patient enrolled in the study.      Quality of life utilizing the Norfolk QOL-DN will be assessed at Months 6 and 12 (based on     the total score as well as the five individual domains of the questionnaire).      QST (utilizing CASE IV), NCS, HRDB, mBMI, and echocardiography will be conducted at Months 6     and 12. Holter monitoring will be conducted at Baseline and Months 6 and 12. Biopsies for     IENF will be obtained at Baseline only. Assessments of troponin I and NT-pro-BNP levels will     be made at each study visit.      Blood samples for pharmacokinetic assessments (Fx-1006A concentrations as well as calculated     steady-state parameters) and pharmacodynamic assessments (TTR stabilization) will be     collected at Week 6 and Months 6 and 12.      Safety and tolerability will be assessed throughout the study. Vital signs, 12-lead ECG,     blood and urine samples for clinical laboratory tests (serum chemistry, hematology,     coagulation panel, urinalysis, and urine pregnancy testing), adverse events, and concomitant     medications will be assessed at each study visit. Eye examinations (including fundal     photography) will be conducted at Months 6 and 12. Abbreviated physical examinations will be     conducted at Week 6, and Months 3 and 6, and a complete physical examination will be     conducted at Month 12.      All patients will be contacted by telephone 30 days (± 1 week) after the last dose of study     medication for assessment of adverse events and concomitant medications.      Patients who complete the Month 12 visit of this open-label study may be allowed to continue     receiving Fx-1006A under a compassionate use program.      Patients who discontinue from the study at any time after enrollment (i.e., early     termination) will have final safety assessments performed at the time of discontinuation. Any     patient discontinuing after the Month 6 visit will have all safety and clinical outcomes     assessments scheduled for the Month 12 visit performed.   "
225047|NCT00791739|"     The study has a double purpose: a first phase intends to assess the effectiveness and     tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in     the treatment of fibromyalgia; a second phase intends to evaluate if the addition of     pregabalin to patients who have shown a partial response to trazodone additionally improves     fibromyalgia symptomatology.   "
225175|NCT00793442|"     The overall hypotheses of this project is that severe sepsis is associated with endothelial     dysfunction; that endothelial dysfunction, in turn, is predictive of subsequent organ failure     and death; and that protocolized resuscitation attenuates endothelial cell (EC) dysfunction     and improves patient survival.   "
225048|NCT00791752|"     The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when     given as single oral ascending doses to healthy volunters. This will be done by comparing the     effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution     and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017     vs time after dose intake will also be collected. The future indication for AZD4017 is     planned to be Type 2 Diabetes Mellitus.   "
225049|NCT00791765|"     The purpose of this study is to determine if etanercept is effective in the treatment of     scalp involvement in moderate to severe plaque psoriasis.   "
225050|NCT00791778|"     Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced     Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen     of chemotherapy.   "
225051|NCT00791791|"     The aim of the present prospective randomized study was to challenge the ability of SSI to     detect painful stimulation during sevoflurane - remifentanil anesthesia.   "
225052|NCT00791804|"     To evaluate the safety and efficacy of self-titration to effective analgesia with inhaled     AeroLEF in patients with moderate/severe acute pain in the post-surgical setting.   "
225029|NCT00791505|"     Antibiotic therapy has been shown to be beneficial in patients with severe acute exacerbation     of chronic obstructive pulmonary disease (COPD). Although recent guidelines support the use     of new antibiotics there is no evidence that newer antibiotics are any better than older     agents. The choice of antibiotic to be used in this situation is challenging to the clinician     who must choose between traditional antibiotics (cyclins, aminopénicillins, cotrimoxazole...)     and new antimicrobial agents. Indeed, available comparative studies did not show an obvious     superiority of new antibiotics compared to their predecessors . Taking into account bacterial     agents associated to COPD exacerbations, one must choose an antibiotic which has the best     activity against Haemophilus influenzae, Streptococcus pneumoniae and Branhamella     catarrhalis. News quinolones are represented as an interesting alternative to standard     antibiotics because of their large spectrum of action and of their pharmacokinetic advantages     allowing high tissue penetration in the pulmonary parenchyma and tracheobronchial tree. Data     on their use among patients having moderate exacerbation of COPD are encouraging but their     effectiveness in more severe presentations is not established. The objective of this     randomized controlled and double blind study is to evaluate the effectiveness and tolerance     of ciprofloxacin compared to trimethoprim sulfamethoxazole in patients admitted to ICU for     severe exacerbation of COPD requiring mechanical ventilation.   "
225030|NCT00791518|"     A multicenter study to evaluate lung function and symptoms in subjects with COPD who have     been on regular use of only one long-acting bronchodilator.   "
225031|NCT00791531|"     Previous investigations indicate that methotrexate, an old anticancer drug, could be used at     low doses to treat malaria. This is a phase I evaluation to assess the safety and     pharmacokinetic profile of this drug in healthy adult male Kenyan volunteers.   "
225032|NCT00791544|"     The primary objective of the study is to select the dose of AVE1642 to be administered in     patients with liver carcinoma not eligible for local treatment.      The secondary objectives of the study are:        -  To evaluate the safety profile of AVE1642 as single agent and the safety profile of          combinations with other anti-cancer therapies of interest in liver carcinoma , including          detection of immunogenicity.        -  To evaluate pharmacokinetics and pharmacodynamics profiles of AVE1642 as single agent or          any PK interactions when given in combination with other anti-cancer therapies.        -  To assess the preliminary clinical activity in terms of response rate (Complete response          + Partial response), duration of responses, stabilisation rate and duration of          stabilisation, according to RECIST criteria.        -  To assess the biological activity at the tumor level.   "
225033|NCT00791557|"     Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease     (Crohn's or ulcerative colitis) and pyoderma gangrenosum.      This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2     weeks initially, then every 1-2 months later in the study.   "
225034|NCT00791570|"     The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 or     A*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in     patients with Neovascular Maculopathy, including Age Related Macular Degeneration   "
225035|NCT00791583|"     1. Baseline performance in maximal barrier precaution technique of Emergency Medicine (EM)          residents, certified in CVC placement, is poor        2. Simulation-based training in maximal barrier precaution technique during central venous          catheter (CVC) placement will improve baseline performance of EM residents   "
225036|NCT00791596|"     This Research study aims to investigate the long term effectiveness of a workstation     ergonomic intervention for work-related posture and low back pain (LBP) of Video Display     Terminal (VDT) workers   "
225037|NCT00791609|"     Feasibility of accurate differentiation between malignant and benign tissue using the FOSTI     device on surgically removed tissue   "
225038|NCT00791622|"     The purpose of this study is to 1) determine whether the effect on QT interval corrected     (QTcLD) for heart rate using the population specified linear derived method at steady state     is comparable between 12 mg paliperidone extended-release (ER) once daily and that of 400-mg     quetiapine administered twice daily, 2) to explore the relationship between the     pharmacokinetics of paliperidone ER and electrocardiogram (ECG) parameters of interest, 3) to     explore the cardiovascular safety and tolerability of 18 mg paliperidone ER at steady state,     and 4) to evaluate the safety and tolerability of all treatments.   "
225039|NCT00791635|"     The goal of this study is to learn if certain characteristics of gynecological cancer can     help researchers predict how well a patient recovers from pelvic exenteration surgery.     Researchers will compare the types of surgery completed and procedures used to find out which     are most effective and safe. Researchers will also study how the surgery affected your     quality of life.   "
225040|NCT00791648|"     Aim1a: Statin naive patient's scheduled for cardiac surgery will be randomized to 80mg     atorvastatin or placebo on the day prior to surgery and then 40mg daily thereafter until     hospital discharge to test the hypothesis that short-term atorvastatin use decreases:        1. acute kidney injury following cardiac surgery.        2. postoperative delirium following cardiac surgery.      Aim1b: Patients using statins preoperatively will be randomized to atorvastatin 80mg or     placebo on day of surgery and 40mg or placebo on postop day 1 with resumption of preoperative     statin therapy on postop day 2 to test the hypothesis that short-term atorvastatin use     decreases:        1. acute kidney injury following cardiac surgery.        2. postoperative delirium following cardiac surgery.      Endpoints include glomerular filtration, urine and plasma markers of renal dysfunction,     markers of oxidative stress, mitochondrial function, systemic inflammatory markers, delirium,     dialysis, stroke, myocardial infarction, time to extubation, ICU length of stay, and death.   "
225041|NCT00791661|"     A single rising dose study to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM).     The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe     and well tolerated, based on the assessment of clinical and laboratory evaluations and     adverse experiences, in Japanese participants with T2DM.   "
225176|NCT00793455|"     The purpose of this study is to evaluate whether patient outreach is effective at increasing     compliance with preventive screenings ordered by their physician. We hypothesize that     educational outreach may increase completion rates.   "
225053|NCT00791817|"     Half the group will be given a high fat diet and the other half will fast. They will then be     crossed over.   "
225054|NCT00791830|"     Angiotensin II receptor blockers (ARB) are known to preserve kidney function among patients     with kidney diseases and reduced renal function, but not among haemodialysis patients.      Haemodialysis patients often lose residual renal function after initiating dialysis leading     to worsened quality of life, increased morbidity and mortality.      In this study an ARB is investigated in a double blind, randomised, parallel group, placebo     controlled manner to see, if this ARB can save residual renal function among haemodialysis     patients. Potential cardiovascular benefits of the treatment are also addressed.   "
225055|NCT00791843|"     PP1- The purpose of this study is to determine whether giving more of the hormone produced by     everyone called growth hormone releasing hormone (GHRH) can improve heart function in     individuals with congestive heart failure. You must be 50 years old or older, have a     diagnosis of congestive heart failure, and have a high likelihood of having lower than normal     growth hormone effect. GHRH is approved by the US FDA for treatment in children with growth     hormone deficiency because GHRH stimulates Growth Hormone (GH). Its use for treatment of     congestive heart failure in adults is investigational.      Growth hormone releasing hormone is a hormone produced in the brain. We will be using     synthetic hormone made in the laboratory. It is identical to the hormone in the brain.      Many older people, due to aging have low levels of growth hormone. The aim of this study is     to find out whether restoring growth hormone levels to the levels found in younger     individuals and then maintaining those levels for 12 weeks will help strengthen heard muscles     in older persons with congestive heart failure.   "
225056|NCT00791856|"     This is an open-label, multiple-dose, randomized, two-period crossover bioequivalence study     in approximately 110 surgically or naturally postmenopausal women on stable hormone therapy     (i.e., estrogen for surgically postmenopausal women or a continuous regimen of estrogen plus     progestin for naturally postmenopausal women) restricted to approved oral or transdermal     regimens only, or not on concomitant hormone therapy.   "
225057|NCT00791869|"     The aim of the investigators research is to see if variants in a particular gene (named     CYP2B6) affect how the body metabolizes (breaks down) certain medications, including the drug     bupropion. Bupropion is widely used in the treatment of depression and for helping people     quit smoking. Genes are portions of DNA that code for particular proteins in the body. The     investigators are studying the gene that codes for a protein called CYP2B6. Differences in     the structure of the gene are called variants and may mean that a person metabolizes a drug     faster or slower than a person with a different variant.   "
225058|NCT00791882|"     Objective Primary:      To evaluate the efficacy of social skills training in reducing negative symptoms in patients     with refractory schizophrenia, in comparison with control (befriending group).      Secondary:      To evaluate changes in social functioning.      To evaluate the effect of SST in other dimensions of psychopathology: positive symptoms,     depression and general psychopathology.      To evaluate the impact of SST in cognition.      Hypothesis Social skills training is more effective than control group (Befriending) in     reducing negative symptoms in patients with refractory schizophrenia.   "
225059|NCT00791895|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving     blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal     insulin therapy.   "
225060|NCT00791908|"     The primary objective of this study is to determine whether laser treatments over 6 weeks     using the pulsed dye laser system or the potassium titanyl phosphate (KTP) laser are     effective in patients with cherry angiomas as observed by a physician provider and the     subject.      The investigators hypothesize that the two laser treatments will be an effective tool for     treating cherry angiomas. The investigators aim to compare these modalities to     electrodessication, as all three modalities are considered the current standard of care.     Electrodessication can result in atrophic lesions at the site of the treated cherry angiomas.      In summary, the goal of this project is to compare the non-ablative pulsed dye laser and the     AuraTM potassium titanyl phosphate (KTP) laser to each other and to the current standard of     care, electrodessication.   "
225061|NCT00791921|"     The objectives of this study are to verify the superiority in efficacy (American College of     Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus     placebo without coadministration of MTX in active RA patients in whom MTX cannot be     administrated.   "
225062|NCT00791934|"     Study Design:      A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety     and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System     used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.   "
225063|NCT00791947|"     This is a phase II prospective non-randomised clinical trial in newly diagnosed and     previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell     lymphoma.      The treatment schedule will consist of three phases: induction and high-dose consolidation,     followed by autologous stem cell rescue. There will be two different induction schedules: one     for patients in the age range 18-60 years and one for patients aged over 60 years.   "
225064|NCT00791960|"     The purpose of this study will be to determine whether an intravenous dose of dimenhydrinate     (also known as Gravol), given before the induction of spinal anesthesia, will decrease the     incidence of intraoperative nausea and vomiting in patients undergoing Cesarean delivery.      This medication is commonly given during and after the surgery if required, but it is not     known whether a preventative dose will decrease the overall incidence of these side effects.   "
225065|NCT00791973|"     The purpose of this study is to help us to a better understanding of how nose and eye     symptoms are related in patients with allergies.   "
225066|NCT00791986|"     The purpose of this study is to determine whether adding load to slow controlled breathing     training could enhance blood pressure lowering in patients with essential hypertension.   "
225067|NCT00791999|"     The objective of this trial is to investigate the efficacy (American College of Rheumatology     20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with     MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and     immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of     foreign data to the Japanese population.   "
225380|NCT00802412|"     The purpose of this study is to determine whether topiramate is effective as an aid to     smoking cessation for recovering alcohol dependent men.   "
225071|NCT00792051|"     While immunisation of school-age children against influenza is not recommended in Hong Kong,     past experience in Japan and elsewhere suggests that immunisation of children may protect the     wider community through its indirect transmission-limiting impact as well as the direct     immunologic protection afforded vaccinated children themselves. We aim to assess whether     vaccinating children against influenza protects vaccinees as well as their household contacts     from infection.   "
225072|NCT00792064|"     A systematic evaluation of predictors of health related quality of life (HRQoL) leads to     multiple level of data analysis. The aim of the herein described observational project is to     create a transplant patients registry on psychosocial outcomes and to evaluate longitudinally     predictors of HRQoL after different types of solid organ transplantation in the long-term. A     sample size of 700 participants consisting of all solid organ types is envisioned. Data will     be compared with published healthy normative data. Data Evaluation of predictors of HRQoL may     guide development of tailored interventions to reduce complications and to further improve     outcomes.   "
225073|NCT00792077|"     The goal of this clinical research study is to learn if treatments to kill cancer cells     including lenalidomide and/or radiation therapy can help to control symptoms such as sleep     problems and fatigue in patients with chronic lymphocytic leukemia (CLL) and/or breast     cancer.   "
225074|NCT00792090|"     Impact of fermented milk in prevention of cow's milk allergy in new born and infants   "
225075|NCT00792103|"     The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed     by:        -  Subject self-examination skin irritation scores        -  Adverse events        -  Changes in vital signs and ECG parameters      The secondary objective is to evaluate the long term efficacy of NP101 as assessed by:        -  Headache pain free at two hours after patch activation for all initial acute migraine          attacks treated with NP101        -  Headache pain relief at two hours after patch activation for all initial acute migraine          attacks treated with NP101        -  Nausea free at two hours after patch activation for all initial acute migraine attacks          treated with NP101        -  Phonophobia free at two hours after patch activation for all initial acute migraine          attacks treated with NP101        -  Photophobia free at two hours after patch activation for all initial acute migraine          attacks treated with NP101        -  Migraine free at two hours after patch activation for all initial acute migraine attacks          treated with NP101      This study will use an open-label design to assess the long term safety of NP101 (sumatriptan     iontophoretic transdermal patch).      Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not     contraindicated) and received treatment (patch activation) with the study patch for a     qualifying migraine under study NP101-007 will be considered eligible for enrollment into the     open-label study. Subjects will be expected to remain in the study for up to 12 months.   "
225076|NCT00792116|"     Context: Gum chewing has been shown to increase cognitive functioning. With the rise in     standardized testing of school-age children and the concurrent attempts to improve their     scores, finding simple and inexpensive methods to bolster performance is needed.      Objective: To examine the effects of gum chewing on standardized test scores and class grades     in a group of 8th grade math students.      Design: Math classes were randomized to a gum chewing (GC) condition that provided students     with gum during class and testing, or a control condition with no gum (NG) provided during     class and testing. This study was conducted during the Spring 2008 school semester.      Setting: A charter school in Houston, TX.      Participants: All students enrolled in eighth grade math at the charter school were     approached for recruitment in this study. A total of 108 (94%) students participated.     Participants were between the ages of 13 and 16.      Main Outcome Measures: The Texas Assessment of Knowledge and Skills (TAKS), the Woodcock     Johnson III Tests of Achievement (WJ-III), and math class grades were used to assess any     differences in academic performance between the GC and NGC conditions. For purposes of this     study, only the math sections of the WJ-III and TAKS, which are both standardized tests, were     assessed.      Our primary hypothesis was that adolescents in a gum chewing (GC) condition would have     significantly improved standardized test scores and math grades compared to adolescents in a     non-gum chewing (NG) control condition.   "
225077|NCT00792129|"     This study is being undertaken to compare the clinical outcomes of patients that have     unilateral posterolateral lumbar interbody fusion using a traditional open approach versus     the MiLIF procedure based on the MiCOR Precision Bone Allograft, specialized Atavi     instrumentation, and minimally invasive visualization capabilities.   "
225078|NCT00792142|"     RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking     blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Giving bortezomib together with thalidomide and     dexamethasone may kill any cancer cells that remain after high-dose melphalan and stem cell     transplant in patients with multiple myeloma.      PURPOSE: This phase II trial is studying the side effects of giving bortezomib together with     thalidomide and dexamethasone after melphalan and stem cell transplant and to see how well it     works in treating patients with stage I-III multiple myeloma.   "
225079|NCT00792155|"     Autosomal dominant polycystic kidney disease (PKD) is the most common inherited kidney     disease, affecting more than 400,000 people in the U.S. and 5 million people worldwide. PKD     is the 4th most common cause of kidney failure requiring dialysis and/or transplantation.     Over half of all PKD patients develop kidney failure by age 60 years, although age of onset     of kidney disease varies widely, even among members of the same family.      Despite the fact this is a relatively common problem, relatively few patients have been     studied for a sufficient period of time to fully understand how patients are affected over     the course of their lifetime. The reason for creating this repository is to collect     information about PKD so that the investigators may fully understand its complications,     including high blood pressure, heart attack, and stroke. This information may also aid in the     development of improved treatment strategies.   "
225080|NCT00792168|"     Primary: to identify physiologic indicators of venlafaxine treatment response using     quantitative EEG (QEEG) cordance, and to determine if cordance changes are specifically     associated with response to venlafaxine;      Secondary: to determine if cordance changes early in the course (i.e., prior to improvement     in clinical symptoms) of venlafaxine (or another antidepressant if venlafaxine is not     clinically indicated for a particular patient) are predictive of later clinical response.   "
225081|NCT00792181|"     This is an intervention study focusing on both medical and nursing questions. The study is a     joint project between the Ambulance services at four cities in West Sweden and Knowledge and     research centre, PreHospen at University of Borås. The aim is to prove the importance of a     caring relation between a patient and a caregiver in cases when a caregiver treats a patient     with benzodiazepines (Midazolam). The overall aim is to show that knowledge and skills in     both caring science and medicine can be applied at the same time in order to relieve pain and     anxiety in acute myocardial disease.      The nursing intervention involves a professional development course for caregivers. The     course is expected to deepen the caregivers' knowledge about the encounter with patients as     well as cardiovascular treatment.      Following questions are formulated:      A. What are the effects regarding relieving pain and anxiety in acute myocardial disease? B.     What are the effects regarding circulatory influence? C. What are the effects regarding     patients' experiences of the ambulance services? D. What are the effects regarding number of     care days in relation to acute myocardial disease? E. What are the effects of patients'     disease complications?   "
225082|NCT00792194|"     Life expectancy of patients with cystic fibrosis has improved dramatically the last few     years. Respiratory complications remain the main contributory factor to the morbidity and     mortality associated with the disease. Exercise tolerance is reduced as the disease     progresses, and peak aerobic capacity seems to be linked with survival. Regular physical     activity has positive benefits, including a better body image, an improvement of pulmonary     function, of exercise capacity and a possible improvement of quality of life.But because of     the considerable variability of the subjects, exercise programs should be tailored to     individual needs, and easy included in their cumbersome treatment routines and professional     activities. In the cystic fibrosis center of Strasbourg we are able to propose to the     patients a one-year physical exercise program, partly supervised with coaches, at home.     Electronically braked cycle ergometer and heart rate monitoring system are at patients     disposal, for one year, at home. Thus, patients can choose, during the day, the best moment     to work out .Subjects will be randomised in two groups:1. a control group, where subjects are     asked to continue their normal daily activities and physiotherapy regime.2. a training group,     where subjects are asked to exercise three times a week. For the training group, three times     a week, patients will train for 30 minutes. Heart rate will be continuously monitored and     send to the medical staff every week-end . A correction of exercise intensity, if needed, is     weekly proposed to maintain a maximal training efficiency, and coaches can help them, if     necessary. For the two groups, quality of life will be measured with a disease-specific     questionnaire (CFQ14+) (Henry, 1998, Quittner, 2000), and a generic questionnaire (SF 36)     (Gee, 2002) before the program, and after 6 and 12 months. After a one year training program,     and compared to the control group, we should expected an improvement in aerobic capacity and     peak oxygen consumption, both associated with improved prognosis in cystic fibrosis. We also     expected to observe an improvement in quality of life measurement, shorter hospital stays and     fewer exacerbations. With this kind of program, we also would like to improve the degree of     adherence in daily life exercise.   "
225083|NCT00792207|"     Hypothesis: Overweight subjects using a Virtual Coach will demonstrate improved adherence to     an exercise regime.      This study is designed to examine the effect of a computer program called a Virtual Coach     and find out if it helps people become more active. This program acts as a kind of a personal     trainer and will give you feedback. All participants in the study will receive an activity     monitor to wear during the study and a website to use to track activity. Half of the     participants will also receive the virtual coach software. This software will have to be     downloaded onto your computer, and we will ask that you check in with the coach using the     software three times a week for 12 weeks. The group you will be placed in will be selected by     chance.   "
225084|NCT00792220|"     Stroke, the most common cause of permanent disability, the second most common cause of     dementia and third most common cause of death, has tremendous socio-economic consequences.      Currently, systemic thrombolysis with the tissue plasminogen activator represents the only     causal and approved treatment for acute ischemic stroke. However, the chances to save the     brain tissue by a thrombolytic therapy exponentially decrease with proceeding time after     onset of symptoms.      In most cases, the beginning of the thrombolysis therapy is delayed by a variety of factors,     like delivery to the hospital, re-examinations and delay of blood analysis or of CT scans.     Due to this, a thrombolytic therapy is possible only in a minority of the stroke patients     (2-5 %). The aim of this study is to investigate whether a Mobile Stroke Unit, a rescue car     with an integrated CT scanner, necessary for essential diagnostics, contributes to a better     stroke management by saving precious time until a therapeutic decision is made. The trial is     planned as a monocentric, randomised prospective trial.   "
225101|NCT00792441|"     Prolong mechanical ventilation cause to respiratory muscle weakness and high risk to weaning     failure,the investigators hypothesize that        1. Specific inspiratory muscle training (SIMT) using threshold loaded breathing device          (BreatheMAX V.1)in patients with ventilator dependence will improve inspiratory muscle          strength        2. SIMT will improve lung function in patients with ventilatory dependence.        3. SIMT will improve weaning success in patients with ventilatory dependence.   "
225085|NCT00792233|"     Polyarticular juvenile idiopathic arthritis (Poly JIA) is a form of juvenile arthritis, which     is a chronic disease affecting approximately 250,000 people younger than 16 years of age.     Poly JIA can be treated with anti-tumor necrosis factor (anti-TNF), a type of medication that     is often effective but also has some toxic side effects and is expensive. Among those with     poly JIA who are effectively treated with anti-TNF, some can remain healthy off the     medication, but some begin to feel the effects of their disease again once the medication is     stopped. This study will attempt to find whether certain tests or signs can predict which     people with poly JIA can safely stop their anti-TNF medications.   "
225086|NCT00792246|"     Determine how much voriconazole is absorbed when the product is given by mouth to children     with extensive graft versus host disease after a stem cell transplantation and determine the     correct dosing of voriconazole in this population.      Hypothesis: Children with gastrointestinal graft versus host disease will have decreased     absorption of oral voriconazole and require higher doses of voriconazole in order to prevent     or treat fungal infections.   "
225087|NCT00792259|"     The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve     Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified     predicate device. In addition, this protocol performs a comparison of the thickness     measurement results from images collected and analyzed with the Zeiss Stratus OCT to images     collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer     for analysis.   "
225088|NCT00792272|"     Dialysis patient could be more aspirin resistant than the general population based on data     from chronic kidney disease patients   "
225090|NCT00792298|"     A cross-over, polysomnography study to test the safety, tolerability and effectiveness of     different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.   "
225091|NCT00792311|"     Low current electrical stimulation test, also called the Tsui test, has been used     successfully to confirm the catheter location in the epidural space in various patient     populations. The results of this study will show whether or not doing a Tsui test can predict     inadequate epidural analgesia early in the course of placing the epidural, so that the     appropriate measures could be applied immediately upon gathering unfavorable results.   "
225092|NCT00792324|"     The purpose of the study is to examine the effect of switching from an antiretroviral     combination that includes efavirenz (Susitiva®), in individuals experiencing     efavirenz-related side effects, and replacing this with an investigational HIV medication     called Etravirine (TMC125).      The study will primarily investigate the effect of change in medication on your viral load     (the levels of the HIV virus in your blood), on immunological parameters (CD4 count), on     other safety parameters (such as cholesterol) your side effects and also on your quality of     life.   "
225093|NCT00792337|"     We hypothesize that simvastatin in combination with ICS might have synergistic     anti-inflammatory effects on airway inflammation in asthmatic patients   "
225094|NCT00792350|"     In this international non-interventional post-marketing surveillance study we want to     evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib     (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the     tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the     duration of Sorafenib treatment.   "
225095|NCT00792363|"     The purpose of this study is to investigate the effect and the side effect profile of     irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with     metastatic colorectal cancer without KRAS mutations.   "
225096|NCT00792376|"     The purpose of this study is to evaluate etoricoxib efficacy in pain control, leg stiffness     and functional recovery of patients suffering acute Achilles tendinopathy.      It is hypothesized that etoricoxib (120mg orally/day/7 days) efficacy is not inferior to     diclofenac (150mg orally /day/7 days) for pain control in subjects suffering acute Achilles     tendinopathy.   "
225097|NCT00792389|"     Double blind RCT comparing elective laparoscopic cholecystectomy using warmed, humidified gas     (new) against laparoscopic cholecystectomy with cool, dry gas (usual). Sample size of 200     patients. Outcome measures are postoperative opiate analgesia use, and post operative     numerical pain scores.   "
225098|NCT00792402|"     Objective: To assess the effectiveness of implementation process of an electronic Heart     Failure guideline in primary care in the city of Barcelona.   "
225099|NCT00792415|"     The purpose of this study is to assess the validity and reliability of an abstinence syndrome     assessment tool used in pediatric patients with iatrogenic opioid dependence.   "
225100|NCT00792428|"     The purpose of this study is to determine whether a non-painful, non-invasive,     brain-stimulation technique called transcranial direct current stimulation (tDCS) combined     with traditional physical-occupational therapy (OT) will improve motor function in patients     with chronic stroke. The aim is to determine the effect of applying real (anodal and/or     cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on     both hemispheres - in a dual configuration - to improve motor function in chronic stroke     patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS     is applied to the brain's motor region during motor learning. The effects after a single     session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per     day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in     stroke patients have shown that improvements in motor functions can be seen and that effects     may last for at least 30 minutes. Patients enrolled in this trial will be randomized to     receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days.     Assessments will be done about 3 days and 7 days after the end of the experimental treatment     by investigators who are blinded to the intervention. Patients are also blinded as to whether     they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor     regions in combination with PT-OT results in a subsequent improvement in motor function of     the recovering hand over sham tDCS in combination with PT-OT.   "
225102|NCT00792454|"     The mortality rate of treated patients with end stage renal disease(ESRD)is 22 deaths     patient-years at risk in 2006. Incident patients with ESRD are most vulnerable within the     first 90 days of dialysis, with an annualized mortality rate of 50 deaths/100 patient years.     The vast majority of these deaths are due to cardiovascular causes. As cardiac rehabilitation     programs have shown a 20% reduction in one year overall mortality rate post myocardial     infarction the investigator proposes that a similar type of rehabilitation program will also     have a benificial effect on morbidity and mortality in patients with chronic kidney     disease(CKD)and ESRD.The overall goal of this project is to study whether a renal     rehabilitation program based on guided exercise implemented in patients with stage III and     stage IV CKD can influence the mortality rate of these patients prior to and during the first     90 days of dialysis      Hypothesis:The application of a guided exercise program (renal rehabilitation) instituted in     patients with stage III or Stage IV CKD will decrease the mortality rate prior to the     initiation of renal replacement therapy.      Hypothesis:The application of renal rehabilitation during the late stages of CKD will     decrease the mortality risk during the first 90 days of renal rehabilitation therapy.      Hypothesis:A guided exercise program will have an immediate and prolonged effect on activity     levels, mental health and adaption to chronic illness in patients with advanced CKD.   "
225113|NCT00792610|"     At the time of the present study, the necessity for booster vaccinations for the prevention     of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become     seronegative for HB markers after complete neonatal HB vaccination was in question. A booster     vaccination strategy may lead to a significant economic impact on national health care     resources, and the costs/benefits must therefore be carefully evaluated. Unfortunately, the     data to support such analyses are lacking. Because an increased risk of HB infection is     anticipated when adolescents enter into young adulthood through becoming sexual active,     breakthrough infections such as fulminant HB might be the main concern instead of the risk of     chronic HB carriage. To address this issue, this study aimed to measure the booster responses     after HB vaccination in seronegative young adults who had completed neonatal HB vaccines in     Taiwan before.   "
225103|NCT00792467|"     This is a single-center, open label, phase II study aimed at testing the activity of multiple     cycles of ITF2357 followed by Mechlorethamine administered to patients with     relapsed/refractory Hodgkin's lymphoma.      Patients will receive a maximum of twelve 3-week cycles of ITF2357 followed by     Mechlorethamine according to the following schema:        -  ITF2357, 50 mg every 6 hours, per os, days 1 - 3        -  Mechlorethamine, 6 mg/sqm, intravenously , day 4      Study therapy will be administered every 21 days as long as there is no evidence of     progressive disease or unacceptable adverse events or patient's request to discontinue     treatment occurs, but in any case for a maximum of 12 cycles.      Decision regarding the continuation of ITF2357/Mechlorethamine therapy will be made on (i)the     basis of tumor reassessment following cycles 2, 6, 9, and 12 and (ii) the occurrence of     toxicity. Tumor response will be evaluated according to the International Working Group     response criteria HL.      Treatment will be administrated on an outpatient basis and patients will be followed     regularly with physical and laboratory tests, as specified in the protocol; in case of     hospitalisation, the treatment will be continued or interrupted according to the     Investigators' decision.      The study will accrue 23 patients evaluable for efficacy and the anticipated duration of the     study is about 24 months.   "
225104|NCT00792480|"     The purpose of this study is to determine if an organized, consistent program of dietary and     lifestyle counseling will prevent excessive gestational weight gain.   "
225105|NCT00792493|"     The purpose of this study is to evaluate the safety and tolerability of escalating multiple     doses of ORM-12741 in healthy volunteers   "
225106|NCT00792506|"     This is open label, phase IIa High Pulse Dose Clinical Trial testing ITF2357 (orally     administration)in adult patients with relapsing/refractory multiple myeloma after at least 2     previous lines of treatment.      Patients will receive ITF2357 in accordance with following scheme:      Weeks 1-6      Patient #01 will be administered ITF 2357 at 400 mg in one single dose on day 1, 8, 15, 22,     29 and 36. Safety assessments will be performed twice a week. If no issue (grade >3     neutropenia or any other grade ≥3 toxicity) emerges at day 15 two further patients (#02 and     #03) will be enrolled and receive the same dose. If patients #02 and #03 show a favourable     safety profile at day 15, and in the meantime no safety concerns arise from patient #01, the     further patients will be enrolled and treated according to the below reported scheme:        -  8 more patients (#04-11) will receive 400 mg once weekly; safety assessments will be          performed weekly.        -  1 patient (#12) will receive 600 mg once weekly; safety assessments will be performed          twice a week.      If no safety concern emerges from patient 12 at day 15, two further patients (#13 and #14)     will be enrolled and treated with 600 mg once weekly. If patients #13 and #14 don't show     relevant safety concerns (grade >3 neutropenia or any other grade ≥3 toxicity) at day 15, and     in the meanwhile patient #12 maintains a favourable safety profile, eight further patients     (#15-22) will be recruited and receive the same treatment regimen.      If grade >3 neutropenia or any other grade ≥3 toxicity appear at any time during week 1-6,     the treatment will be permanently discontinued.      In this phase treatment will be administered on an inpatient basis.      Weeks 7-12      For patients still on therapy at day 43 visit, M protein will be quantified and the treatment     continued or possibly modified as follows on the basis of this parameter:      Decrease >or= of 25%:      patients in 400/week group continue 400mg for 6 further weeks patients in 600/week group     continue 600mg for 6 further weeks      Stable +or- of 25%:      patients in 400/week group increase to 600mg and continue for 6 further weeks patients in     600/week group add dexamethasone 40mg for 4 days/week (day 1-4) and continue 600mg for 6     further weeks      Increase > of 25%:      patients in 400/week group add dexamethasone 40mg for 4 days/week (day 1-4) and continue     400mg for 6 further weeks patients in 600/week group failure:out of the study patients in     600/week group      Safety assessments will be performed at weekly intervals. In case of grade >3 neutropenia or     any other grade ≥3 toxicity the treatment will be permanently discontinued.      In this phase treatment will be administered on an inpatient basis.      Weeks 13-18      For patients still on therapy at day 85 (week 13, day 1), the response rate will be     quantified according to EBMT criteria. In case of response (complete, partial or minimal) or     stable disease (no change) the treatment will be prolonged until week 18, whereas in case of     disease progression the patient will leave the study. A new complete efficacy evaluation will     be performed at day 127 (end of treatment).      During this phase safety will be assessed at weekly intervals and in case of grade >3     neutropenia or any other grade ≥3 toxicity the treatment will be permanently discontinued.      This phase of the study will be conducted on an outpatient basis.      No dosage modification or temporary discontinuation is admitted      Primary objective:      To assess the safety of ITF2357 administered once weekly at high pulse dose in patients with     relapsing/refractory multiple myeloma.   "
225107|NCT00792519|"     This study will determine whether a cognitive behavioral intervention that demonstrates     strong evidence in the U.S. of reducing alcohol use is effective when delivered by     paraprofessionals in Kenya and compared against a usual care support group.   "
225108|NCT00792532|"     The purpose of this study is to determine the safety and effectiveness of a new procedure for     placing DBS electrodes, in which the entire surgery is performed within an MRI scanner     (interventional MRI), with the patient fully asleep (under general anesthesia). The     standard method for the placement of deep brain stimulators does not use MRI during the     actual DBS placement. The standard method involves placement of a rigid frame on the     patient's head, performance of a short MRI scan, transport to the operating room, placement     of the DBS electrodes in the operating room, and return to the MRI suite for another MR to     confirm correct electrode placement. In the standard method, the patient must be awake for     2-4 hours in the operating room to have brain mapping performed, where the brain target is     confirmed by passing microelectrodes (thin wires) into the brain to record its electrical     activity. In the standard method, general anesthesia is not required. In this study, the     surgery is guided entirely by MRI images performed multiple times as the DBS electrode is     advanced. This eliminates the need for the patient to be awake, and eliminates the need for     passing microelectrodes into the brain before placing the permanent DBS electrode.   "
225109|NCT00792558|"     The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects     with advanced cancers   "
225110|NCT00792571|"     This is an open-label extension study for patients who participated in the BPS-MR-PAH-201     study.   "
225162|NCT00793273|"     This study is conducted in Europe. The aim of this observational study is to observe the     efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice     in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin     initiation is evaluated.   "
225177|NCT00793468|"     The purpose of this study is to determine the effect of GSK598809 as compared to placebo in     preventing recently-quit smokers from going back to smoking.   "
225111|NCT00792584|"     Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams,     dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of     treatment, with subsequent attenuation but may not completely resolve even years after     efavirenz initiation.      The investigators plan a twelve week, randomized, placebo-controlled, double-blind study. In     group 1, efavirenz will be replaced with efavirenz placebo plus etravirine, in group 2,     efavirenz would be continued, and etravirine placebo given in addition. After six weeks,     patients in group 1 would switch to the regimen of group 2, and vice versa.      The primary endpoint of the trial will be patient preference. Sleep quality, daytime     sleepiness, and anxiety will also be investigated.   "
225112|NCT00792597|"     The purpose of this study is to compare the hemoglobin results obtained with 1) the HemoCue™,     2) the Masimo SpHb™, and 3) the UCSF Clinical Laboratory. The goal is to determine if these     three values differ from each other during various levels of blood loss in the clinical care     of patients for spine revision and hip revision surgery.   "
225114|NCT00792623|"     This study aims to assess the immunogenicity and safety of varicella vaccination in a     population of autologous peripheral stem cell/ bone marrow transplantation recipients who     have reached at least four months post-transplantation.   "
225115|NCT00792636|"     The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen     sodium combination tablets, tablets containing only sumatriptan, and tablets containing only     naproxen sodium when these drugs are taken to treat migraine headaches that occur during a     6-month period.   "
225116|NCT00792649|"     Colonoscopy is the accepted gold standard for screening of colorectal cancer. However, small     and flat neoplastic lesions might be overlooked with standard video endoscopes. The new     available EPKi system (Pentax, Japan) enables with HD+ imaging resolution above HDTV     standard. Aim of the study was to test the efficacy of HD+ colonoscopy alone and in     conjunction with I-Scan (newly developed post processing digital filter)in comparison to     standard videoendoscopy   "
225117|NCT00792662|"     The primary purpose of this study is to determine if the study medication Methylphenidate     (Ritalin) will improve subject's blood-sugar control by improving their motivation more than     placebo. The secondary objectives of the study are to determine if daily functioning and     quality of life improves with methylphenidate treatment.   "
225118|NCT00792675|"     The goal of this study was to evaluate the effect of exercise on the number of swollen and     tender joints associated with rheumatoid arthritis. It was hypothesized that persons would     have less inflammation associated with rheumatoid arthritis after a 12 week exercise program     of treadmill walking and weighlifting. Immune parameters were measured to determine potential     mechanisms responsible for changes in inflammation with exercise.   "
225119|NCT00792688|"     The primary objectives of this study are to evaluate safety and efficacy of topically applied     Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic     surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower     eyelids. The study will observe the effects of the topical agent over the course of 1 month     following the initial treatment.   "
225120|NCT00792701|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after     surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses.     In this case, observation may be sufficient.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with cisplatin     works in treating patients with stage I non-small cell lung cancer that was removed by     surgery.   "
225121|NCT00792714|"     The general objective of the study is to estimate the systemic pharmacokinetics of mannitol     after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis     patients.   "
225122|NCT00792727|"     Ketoprofen in a topical patch formulation has been demonstrated to be effective for treating     mild to moderate pain caused by various musculoskeletal disorders.   "
225123|NCT00792740|"     The study will be conducted according to a randomized, double-blind placebo-controlled,     parallel group design in up to 25 clinical sites in Europe.      Patients will be randomly assigned to two parallel treatment groups (1:1 randomization ratio)     receiving either ITF2357, as hard gelatine capsule for oral administration, at the dose of 50     mg b.i.d. (total daily dose of 100 mg), or matching placebo capsules,. Treatment will be     administered on an outpatient basis for 8 consecutive weeks, followed by a 4-week follow-up.     During screening, in the 8-week treatment period and in the 4-week follow-up period, patients     will attend scheduled visits, with physical and laboratory assessments, in order to monitor     disease evolution and safety and tolerability of ITF2357.      The study will be conducted in up to 80 patients of both genders, with established diagnosis     of CD, who present with ulcerations greater than aphthous ulcers in at least one of the five     bowel segments investigated endoscopically, from the ileum to the rectum, with endoscopic and     clinical evidence of moderate-to-severe active disease, not controlled by on-going treatment     with conventional therapies such as 5-aminosalycylates, steroids or immunosuppressants.   "
225191|NCT00787813|"     The aim of the study is to evaluate the effect of N-acetyl cysteine (NAC) on pregnancy     outcome in women undergoing cervical cerclage for cervical insufficiency.   "
225192|NCT00787826|"     This study is designed to determine the safety and immunogenicity of a Live Francisella     tularensis Vaccine   "
225124|NCT00792753|"     Randomized Study To evaluate the safety and effectiveness of the Elixir Medical DESyne     Novolimus-Eluting Coronary Stent System with Durable Polymer through the assessment of     clinical, angiographic and IVUS endpoints as compared to the concurrently enrolled Medtronic     Zotarolimus-Eluting Coronary Stent System in a randomized, single blind study of up to 200     male and female patients. In a Continued Access Registry of up to 100 patients receiving the     DESyne Stent clinical-only endpoints will be evaluated.      To evaluate the safety and effectiveness of the Elixir Novolimus-Eluting Coronary Stent     System with bioabsorbable polymer as compared to the Medtronic Endeavor Zotarolimus-Eluting     Coronary Stent System control through clinical and angiographic endpoints.   "
225125|NCT00792766|"     This is an open label long term follow up study, open to those subjects who were previously     enrolled inRAD001 Therapy of Angiomyolipomata in Patients with Tuberous Sclerosis Complex     and Sporadic Lymphangioleiomyomatosis, CCHMC IRB #2008-0812 and who meet the criteria for     this long-term follow-up study.      The hypothesis is that the drug will inhibit the growth of the angiomyolipomas and possibly     even cause regression.   "
225126|NCT00792779|"     The purpose of this study is to determine if propofol could protect erythrocytes by directly     scavenging free radicals from the blood current and increasing resistance of their cell     membranes in patients submitted to gastroplasty.   "
225127|NCT00792792|"     Tissue transfer flaps are a method of moving tissue from a donor location to a recipient     location. In the case of a free tissue transfer flaps, the blood vessels to the transferred     tissues are detached and then re-attached to different arteries and veins at the recipient     site. The process of reconstructive surgery using tissue transfer flaps is not without     complications. These complications may include acute arterial or venous occlusion, as well as     the development of late complications such as fat necrosis and flap atrophy.   "
225128|NCT00792805|"     This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or     over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.   "
225381|NCT00802425|"     The purpose of the study is to determine whether AM-111 is effective in the treatment of     acute inner ear hearing loss (acute sensorineural hearing loss, ASNHL).   "
225129|NCT00792818|"     Osteoarthritis of knee is common degenerative musculoskeletal diseases. Non-steroidal     antiinflammatory drugs (NSAIDs) are used to decrease pain symptom but someone can not     tolerate its gastrointestinal adverse effects. In vitro studies showed that curcumin had an     inhibitory effect on substances playing an important role in inflammatory pathway. The     mechanisms by which curcumin prevents inflammation are postulated through inhibition of many     cytokines, for example, lipo-oxygenase, cyclo-oxygenase, and phospholipase. Therefore, if     curcumin is effective as NSAIDs with less side effects, it can be an alternative treatment     for those OA knee patients.   "
225130|NCT00792831|"     This is an open label, un-controlled, phase II, pilot clinical trial testing ITF2357 in a     population of CLL patients relapsed after or refractory to conventional chemotherapy or     relapsed after autologus bone marrow transplantation.      Patient will receive ITF 2357 orally at the dose of 100 mg x 2/die for three months with     subsequent dose modifications if requested by the patient's conditions.      Primary objective: To determine overall response-rate, complete response (CR) or partial     response (PR) Secondary objectives: To assess the safety and tolerability of ITF2357; to     assess total rate of responders (complete + partial responders); to determine the 6 months     progression free survival; to determine the effects of the drug on haematological parameters.   "
225131|NCT00792844|"     Main research Question: The investigators would like to find out if both the Bio-K     (lactobacillus acidophilus and lactobacillus casei) drink and capsule are equally effective     in the prevention of diarrhea associated with antibiotic use.      Why is this research project important? About 25% of patients who use antibiotics may develop     diarrhea as a side effect. Symptoms are mild and consist of watery diarrhea and abdominal     pain. Some patients may develop a more severe form of diarrhea, called clostridium     difficile-associated diarrhea. Clostridium difficile-associated diarrhea may lead to more     serious consequences like inflammation of the large bowel and in some cases, death. There are     some studies that suggest Bio-K drink, a probiotic preparation containing lactobacillus     acidophilus and lactobacillus casei, decreases the risk of diarrhea from antibiotic use. As a     result, St. Joseph's Healthcare has recently to use Bio-K routinely to try to reduce risk of     patients developing diarrhea. No other Hamilton hospitals use Bio-K routinely as there is not     strong evidence about the effectiveness of Bio-K for the prevention of diarrhea. This study     will provide more information about Bio-K's effectiveness in the prevention of diarrhea     associated with antibiotic use as both a capsule and a drink.   "
225132|NCT00792857|"     This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease     (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different     dose strengths. This study will also investigate the levels of CTAP201 in the body over time     and determine the safety of CTAP201.   "
225133|NCT00792870|"     Obesity is a major health problem that has reached epidemic levels. Efforts are needed to     develop cost-effective public health approaches for weight loss and maintenance. One such     approach is to develop team-based programs that may motivate people to lose weight and/or     increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI).     The purpose of this project is to evaluate the overall effectiveness of SURI and to test if a     behavioral intervention can enhance the effectiveness of the original program. The current     trial is investigating whether adding a behavioral intervention delivered online would     enhance the outcomes of SURI participants.   "
225134|NCT00792883|"     The purpose of this study is to monitor the respiratory, metabolic and nutritional status of     critically ill pediatric patients undergoing mechanical ventilation and to correlate the     clinical and physiopathological findings with inflammatory activity measurements in order to     identify prognostic biomarkers.   "
225135|NCT00792896|"     Family usually had a lot of burden to tell the truth to patients. The purpose of this study     is to assess the effect of education materials and family conference for advanced cancer     patients and family.   "
225206|NCT00799669|"     RATIONALE: A counseling program that motivates patients to stop smoking and drinking may     reduce the risk of oral cancer. It is not yet known whether motivational stop smoking     counseling or motivational stop-smoking and stop drinking counseling is more effective in     helping patients stop smoking and drinking.      PURPOSE: This randomized clinical trial is studying how well treatment to stop smoking and     drinking works in preventing oral cancer in smokers in Puerto Rico.   "
225136|NCT00792909|"     The purpose of this study is to assess the immune memory induced by primary and booster     vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through     evaluation of the immune responses following vaccination with a booster dose of pneumococcal     conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses     following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in     age-matched unprimed children.      The study also aims to assess the antibody persistence in the fourth year of life following     primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first     year of life.      The study is also designed to evaluate the immunogenicity in terms of antibody response and     the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse     events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the     fourth year of life.      This protocol posting deals with objectives & outcome measures of the booster phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = 00307034)   "
225137|NCT00792922|"     Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious     cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the     eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub     against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO)     has endorsed a multi-faceted strategy to combat trachoma, which includes the use of     antibiotic treatment to reduce the community pool of infection with C. trachomatis. The     objective of this study is to conduct a randomized, community-based trial in three countries     (Niger, Tanzania and The Gambia), representing different baseline endemicities, of     alternative coverages and frequencies of administration of mass antibiotic treatment as well     as to determine the cost-effectiveness of these different strategies from a program     perspective.   "
225138|NCT00792935|"     The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants     taking metformin for type 2 diabetes.   "
225139|NCT00792948|"     This phase II trial is studying the side effects of giving combination chemotherapy together     with or without donor stem cell transplant and to see how well it works in treating patients     with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving     chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the     growth of cancer cells. It also stops the patient's immune system from rejecting the donor's     stem cells. The donated stem cells may replace the patient's immune cells and help destroy     any remaining cancer cells (graft-versus-tumor effect).   "
225140|NCT00792961|"     The study involves use of a device called an endomicroscope to obtain high resolution images     of microscopic structures during robot-assisted prostate cancer surgery. This feasibility     study is largely descriptive, and will use endomicroscopy to document the cellular and     architectural appearance of tissue during minimally invasive prostate surgery for later     comparison with features seen upon conventional histopathological examination of biopsies or     resection specimens.   "
225141|NCT00792974|"     The aim of the study is to develop an interview to ask patients with COPD about their fear of     death and dying, their needs and wishes at the end-of-life. Afterwards, the patients receive     a brief psychological intervention to develop coping strategies for chronic illness. Beside     this a general purpose of this intervention is to improve patients' quality of life.   "
225142|NCT00793000|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of     PF-04287881 after a single oral dose in healthy adult volunteers.   "
225143|NCT00793013|"     Traditional modes of ventilation have failed to improve patient survival. Subsequent     observations that elevated airway pressures observed in traditional forms of ventilation     resulted in barotrauma and extension of ALI lead to the evolution of low volume cycled     ventilation as a potentially better ventilatory modality for ARDS. Recent multicenter trials     by the NIH-ARDS network have confirmed that low volume ventilation increases the number of     ventilatory free days and improves overall patient survival. While reducing mean airway     pressure has reduced barotrauma and improved patient survival, it has impaired attempts to     improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch,     allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure     release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive     airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal     ventilation occurs between the increase in lung volumes established by the application of     CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have     suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration     of pulmonary mechanics, but there are no studies indicating the potential overall benefit of     APRV in recovery form ALI/ADRS.   "
225144|NCT00793026|"     The purpose of this study is to prove the safety of the gynaecological formulation in normal     conditions of use.   "
225145|NCT00793052|"     The purpose of this study is to determine whether Etodalac, Etoricoxib and Dexamethasone are     effective for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery   "
225146|NCT00793065|"     The investigators will conduct a longitudinal cohort study with concurrent controls. The     investigators will include all primary care physicians in the Hudson Valley including family     practitioners, internists, and pediatricians. The purpose of this study is to determine the     effects of implementing electronic health records (EHRs), pay-for-performance incentives for     physicians (P4P), and Medical Home redesign on health care quality, cost and patient     experience in the Hudson Valley.   "
225172|NCT00793403|"     This is an observational study of composite indices, including the CLARA (CLinical ARthritis     Activity) index, in rheumatoid arthritis (RA) patients in routine clinical practice in Italy     in order to evaluate clinical remission and low disease activity. Data will be collected only     from patients providing informed consent. In this study we aimed to assess the psychometric     properties of a new composite instrument termed CLinical ARthritis Activity (PRO-CLARA) that     uses only three PRO measures from among the 7 ACR Core Data Set. We hypothesized that this     index would facilitate rapid and easy RA activity assessment in daily routine.   "
225147|NCT00793078|"     Arterial blood pressure (ABP) is regulated by multiple, interconnected feedback loops     resulting in a variable and complex time course. According to the decomplexification theory     of illness, disease is characterised by a loss or impaired function of feedback loops     resulting in a decreased complexity of the ABP-time course and an impaired adaptability of     the cardiovascular system.      Decomplexification of physiologic parameters has been shown to occur in coronary heart     disease, Parkinson's and Hodgkin's disease, and in subarachnoid hemorrhage, but has not been     evaluated in sepsis.      This study is intended to test the hypothesis that complexity of ABP        -  is lower in cardiac surgery versus non-cardiac surgery septic patients,        -  decreases as severity of sepsis increases to severe sepsis and septic shock,        -  is associated with outcome three month after sepsis.   "
225148|NCT00793091|"     The purpose of this study is to determine the safety and efficacy of C-KAD Ophthalmic     Solution in improving visual acuity relative to placebo in patients with age-related cataract   "
225149|NCT00793104|"     Determine the ability of the allograft plug for the treatment of a cartilage injury in the     knee   "
225150|NCT00793117|"     Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a     prevalent option to treat this disease.During usage of different techniques of surgery, the     need for packing after surgery is debatable problem. So to solve this problem this research     has been designed.   "
225151|NCT00793130|"     The aim of the study is to reduce the severity and duration of acute attacks, to prevent the     recurrence of new acute attacks and to improve patient's quality of life.      Coltect contains anti inflammatory and antioxidant natural agents (curcumin, green tea and     selenomethionine) which are associated with a positive effect on inflammatory disease.      The investigators assume that Coltect represents a tolerable and mild treatment, viable     alternative to other medical therapies with fewer side effects.      Coltect is a food supplement that contains active ingredients from herbal sources.   "
225382|NCT00802438|"     A drug (mepolizumab) that reduces allergic inflammation will affect the function of allergy     cells called eosinophils which are produced by the body in response to allergen exposure.   "
225152|NCT00793143|"     Bariatric surgery in the treatment of morbid obesity is associated with long-term weight-loss     and decreased overall mortality. Long-term results have been reported for laparoscopic     gastric bypass procedures but the long-term results of laparoscopic sleeve gastrectomy are     yet unavailable. As sleeve gastrectomy is a rapid and less traumatic procedure with good     short-term results of weight loss and resolution of comorbidities, the investigators     initiated a prospective randomized two-center study comparing laparoscopic sleeve gastrectomy     (LSG)with laparoscopic gastric bypass (LGB) in the treatment of morbid obesity. Study     hypothesis: As sleeve gastrectomy is less traumatic, easier and faster to perform compared     with gastric bypass,LSG could become the procedure of choice to treat morbid obesity if the     long-term results of weight loss and resolution of comorbidities are comparable with     laparoscopic gastric bypass.   "
225153|NCT00793156|"     Primary objective of this multicenter, double-blind, placebo controlled, randomized     withdrawal study are to determine the effectiveness and safety of orally administered AC-820     in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated     with end-stage renal disease and hemodialysis, and perform a population PK analysis.   "
225154|NCT00793169|"     The primary objective of this study is to (1) determine whether local injection of lidocaine     used during Mohs surgery will elevate serum lidocaine concentrations to a level that could     cause systemic symptoms and (2) determine whether sustained high levels of serum lidocaine     occur after intralesional anesthesia on the face and neck. This study is a cross-sectional     study of 10 subjects with basal cell carcinoma or squamous cell carcinoma of the face or neck     requiring Mohs micrographic surgery. The study will consist of a brief questionnaire and     blood draws during their Moh's surgical procedure.   "
225155|NCT00793182|"     The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in     subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed     tomography.   "
225156|NCT00793195|"     The aim of this study is to determine the feasibility of conducting a trial to examine the     efficacy of an ω3FA (Omega-3 fatty acid) containing balanced lipid emulsion in the prevention     of progression of PNALD in infants with Intestinal Failure/Short Bowel Syndrome (SBS) and     early liver dysfunction.   "
225157|NCT00793208|"     The study of the vaccine will proceed in two stages after the method of Simon (102). In the     first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic     responses occur, the study will be terminated. If 3 or more responses are observed, the study     will proceed to the second stage, accruing an additional 22 patients. If the second stage is     complete and a total of 9 or more immunologic responses are observed among the 37 patients     treated, the treatment response rate for the vaccine will be considered high enough to     warrant further study. Conversely, if the evaluation of the vaccine concludes at the first     stage, or if 8 or fewer total immunologic responses occur after completing the second stage,     the vaccine will not be considered for further study.   "
225158|NCT00793221|"     Chronic total coronary occlusions (CTO) have an especially high risk of angiographic     restenosis, and need for new revascularization procedures. Drug-eluting coronary stents (DES)     have demonstrated to significantly reduce the risk of restenosis and new revascularization     procedures in comparison with bare-metal stents.      Most data on the efficacy of DES come from the sirolimus-eluting coronary stent Cypher     (Cordis corp.), and paclitaxel-eluting coronary stent Taxus (Boston Sci.), and the Cypher     stent is the only DES that has been randomly tested in CTO. Among second-generation DES,     everolimus-eluting stent (EES) has shown excellent angiographic and clinical results, but     this DES has not been studied in unfavourable scenario (such as CTO).      The aim of the CIBELES trial is to demonstrate the hypothesis that EES are equally effective     in comparison with sirolimus-eluting stents in the treatment of CTO, in terms of angiographic     efficacy considered as in-stent late lumen loss.   "
225159|NCT00793234|"     The purpose of this study is to evaluate the safety and efficacy of a single administration     of TB-402 for the prevention of VTE in patients undergoing knee replacement surgery.   "
225160|NCT00793247|"     This study was designed to investigate the clinical safety, tolerability and efficacy of     prucalopride in improving the symptoms associated with chronic intestinal pseudo-obstruction     (CIP) in subjects with CIP. The study hypothesis was that prucalopride at doses up to 4 mg is     safe, well tolerated, efficacious and improves the symptoms associated with CIP.   "
225161|NCT00793260|"     Compare two care management support program models on medical costs and utilization.   "
225163|NCT00793286|"     Repair of inguinal hernia is the most common operation of the general surgeon. In recent     years, it was recognized that chronic postoperative pain is as important for postoperative     outcome as recurrent hernia. The incidence of pain or discomfort ranges up to 60% of operated     patients. Despite the fact that laparoscopic hernia repair has been shown to reduce     postoperative pain compared to open hernia repair, up to 5% of patients suffer from     persistent discomfort. During that operation the mesh is either fixed using a stapler or     tissue adhesive glue. With the current study we compare postoperative pain between patients     undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or     tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high     sensitivity.   "
225164|NCT00793299|"     In order to gain a greater understanding of the full experience of children with     life-threatening illness, this study will provide video cameras to ten to fifteen 10-18 years     olds in active treatment for cancer, and instruct them to make video illness narratives over     the course of 1-3 months. The narratives will be studied as an intervention; each of the     participants will be administered a measure of physical symptoms (the Memorial Symptom     Assessment scale 10-18) and a measure of self-esteem (the Rosenberg Self-Esteem Scale). The     video narratives will also be analyzed for content by theme in order to understand the     participants' experiences in their own words. Our hypothesis is that these narratives will     provide insight into the lives of children with cancer, increase their self-esteem, and     decrease symptom distress, and improve communication between patients and their doctors.   "
225165|NCT00793312|"     The primary objective is to document the acute and mid-term safety and overall clinical     performance of the Endeavor(TM) Zotarolimus Eluting Coronary stent system in a real world     Chinese patient population requiring stent implantation.      To assess the event rate in patient subgroups with specific clinical indications and/or     vessel or lesion characteristics.   "
225166|NCT00793325|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
225167|NCT00793338|"     The purpose of the study is to evaluate whether sildenafil helps treat heart failure. Some     patients with heart failure have high blood pressure in the lungs (referred to as pulmonary     hypertension). Sildenafil is a medication that is used to treat high blood pressure in the     lungs and may reduce symptoms of heart failure. Studies have looked at the short-term benefit     of sildenafil in patients with congestive heart failure, but this study will look at the     longer-term benefits of 12 weeks of therapy with sildenafil.   "
225168|NCT00793351|"     The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity     allogeneic stem cell transplantation (RIST) with RIC regimen in children with neuroblastoma     who have failed a prior autologous stem cell transplantation. The investigators will     investigate the potential of RIC regimen in inducing antitumor response if the present     protocol will indeed reduce the early TRM and allow for sustained donor chimerism.   "
225169|NCT00793364|"     Since it is very difficult to have the real thing (Mediterranean diet) we need to find an     alternative to reduce cardiovascular disease (CVD) risk in subjects with moderate     hypercholesterolaemia (a major CVD risk factor) living in western countries. Therefore, this     proposed study is designed to assess if giving olive oil supplements, with or without stanol     ester, is equivalent to following a Mediterranean diet. Furthermore, the stanol-olive oil     combination may prove to be superior to olive oil alone.   "
225170|NCT00793377|"     The primary objective of this trial is to compare the rate of pathologically complete     remissions achieved using a preoperative dose-intensified 8 week therapy consisting of     adriamycin and docetaxel with a preoperative sequential 24 week regimen consisting of     adriamycin/cyclophosphamide followed by docetaxel, in patients with operable carcinoma of the     breast. Secondary aims are to assess disease-free and overall survival, the rate of complete     and partial responses by palpation and imaging methods, the rate of breast-conserving     operations, and the toxicity of the two chemotherapy regimens.      Women meeting the following criteria will be eligible for the study: those with operable     breast cancer (T2-3 N0-2 M0), with the diagnosis histologically confirmed by biopsy, and     measurable disease on mammography or sonography or breast MRI (the most appropriate method     should be chosen by the investigator). After the patients have given written informed     consent, they will be randomly assigned to the study treatments. Patients in group I will     receive four cycles of combination chemotherapy consisting of adriamycin 50 mg/m2 (15 min     i.v. infusion) and docetaxel 75 mg/m2 (1 h i.v. infusion) repeated every 14 days, followed by     surgery 9-10 weeks after the start of therapy. Patients in group II will receive four cycles     of adriamycin 60 mg/m2 (15 min i.v.) and cyclophosphamide 600 mg/m2 (1 h i.v.) every three     weeks, followed by four cycles of docetaxel 100 mg/m2 (1 h i.v.) every three weeks. Surgery     will be performed during week 25 or 26. Patients in both groups will additionally receive     oral doses of tamoxifen 20 mg once daily for 5 years, starting on the first day of     chemotherapy. Surgery will consist of removal of the remaining tumor (breast-conserving     resection or mastectomy) and axillary dissection (Sentinel node biopsy is allowed if the     patient is involved in a randomized trial. Radiotherapy is applicated according to standard     proceedings of participating center. A second randomization for additional versus no     additional postoperative chemotherapy is recommended in ypN+ disease. Patients with disease     progression during preoperative therapy, chemotherapy can be stopped and surgery can be     performed immediately.   "
225171|NCT00793390|"     Background:        -  Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly          aggressive form of breast cancer.        -  Three characteristics of IBC tumors their rapid progression, their extensive formation          of new blood vessels, and the fact that these characteristics are present from the          inception of the tumor make it an ideal model for studying factors associated with tumor          aggressiveness.        -  This study is a collaboration among several institutions in the United States and North          Africa that have extensive epidemiological experience and experience with IBC.      Objectives:      - To understand what causes certain types of breast conditions, including IBC.      Eligibility:      - Women 18 years of age and older with IBC and non-IBC and healthy women volunteers are     eligible. Women who have had a previous diagnosis of any kind of breast cancer are excluded.      Design:        -  Participants complete a questionnaire providing information about their background,          including medical and reproductive history, family health history and lifestyle habits          and undergo the following additional procedures:        -  Height, weight, hip and chest measurements.        -  Saliva sample collection to measure biological factors that may be related to breast          conditions.        -  Breast examination and, if permission is given, photographs of affected breast.        -  Analysis of biopsied tissue for genetic and biochemical factors.   "
225173|NCT00793416|"     The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating     the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic     Intracranial Hypertension (IIH) undergoing radionuclide test for suspected shunt obstruction.     This is an exploratory study to determine how a non-invasive device can assist in detection     of presence of flow in these patients.   "
225178|NCT00793481|"     Metabolic Syndrome is a highly prevalent condition that is comprised of several major     clustering factors that increase the risk for developing cardiovascular disease. Diffuse     Optical Spectroscopy is a non-invasively measure can show changes in the microvasculature of     human. Diffuse Optical Spectroscopy measures the optical absorption and scattering properties     of near-infrared light in tissues such as muscle in order to quantify the absolute     concentration of oxygenated and deoxygenated hemoglobin, water, and lipids. It provides     quantitative and functional information on the microvasculature related to tissue perfusion,     metabolic changes, and indicators of tissue damage.   "
225179|NCT00793494|"     The aim of this study is to determine the efficacy of the administration of Bifidobacterium     bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus     Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis     R1058 et Streptococcus thermophilus (Probaclac™) given twice a day for 4 weeks on digestive     symptoms evaluated subjectively in children aged 8 to 18 years with irritable bowel syndrome     versus placebo.      This study is a double-blind randomized controlled study. 84 children will included. After     inclusion, a 15-day period of observation precedes the randomization at Day 0. Patients     receive Probaclac or placebo for 4 weeks. At the end of the treatment period, patients are     followed for a 2-week period of follow-up.      4 visits and 4 phone calls are planned during the study.   "
225180|NCT00793507|"     This pilot project consists of co-locating dental hygienist services in medical primary care     offices. Dental hygienists will work in close collaboration with the primary care offices,     providing preventive dental care to young children either before or after scheduled     well-child visits.   "
225383|NCT00802451|"     The purpose of this study is to evaluate the relative bioavailability of the test formulation     of mesalamine suspension rectal enema with the reference formulation in healthy, adult     subjects.   "
225182|NCT00793546|"     This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in     combination with exemestane versus exemestane alone. This is a 2-part study consisting of a     safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive     bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety     concerns arise, then future eligible subjects will be randomly assigned to the main phase of     the study. They will either receive bosutinib daily combined with daily exemestane, or daily     exemestane alone for a specified period of time. Subjects will be followed up for survival     after treatment discontinuation.   "
225183|NCT00793559|"     terlipressin is given to refractory septic shock patients who do not respond to noradrenalin     in Israel and Europe. It is given by bolus injection. we attempt to investigate weather it is     better to give it by continuous drip and avoid abrupt changes in BP and heart function   "
225184|NCT00793572|"     This phase II trial studies the side-effects and anti-cancer effects of giving an autologous     or syngeneic stem cell transplant followed by an allogeneic donor stem cell transplant and     bortezomib. Patients treated on this trial have newly diagnosed high-risk, relapsed, or     refractory multiple myeloma (MM). Giving chemotherapy before an autologous stem cell     transplant slows or stops the growth of cancer cells by preventing them from dividing or     killing them. Stem cells that were harvested earlier from the patient's blood and frozen are     then returned to the patient to replace the blood-forming cells that were destroyed by     chemotherapy. Giving chemotherapy and total-body irradiation before an allogeneic donor stem     cell transplant also prevents the patient's immune system from rejecting the donor's stem     cells. Undergoing an autologous or syngeneic stem cell transplantation followed by an     allogeneic donor stem cell transplant and bortezomib may be overall more effective in killing     cancer cells.   "
225185|NCT00793585|"     This prospective, randomized controlled study will evaluate the effect of uric acid on the     progression of IgA nephropathy.   "
225186|NCT00793598|"     Twelve renal transplant subjects and twelve hematopoietic stem cell recipients will be     enrolled in Cohort 3A. Subjects enrolled in Cohort 3A will receive 40mg CMX001 or placebo     once weekly for a total of 5 doses. After 12 renal subjects have been enrolled into Cohort     3A, up to three additional cohorts (4A, 4B and 4C) of 12 renal transplant subjects each may     be enrolled in a sequential manner   "
225187|NCT00793611|"     The investigators purpose is to perform a pilot study evaluating the efficacy in hypnotherapy     in treating women with Overactive Bladder Symptoms (urinary urgency symptoms and urinary     frequency). Approximately half the women in the study will receive standard care     (performing a voiding diary, Pelvic Floor exercises, and timed voiding) and the other half     will receive standard care and 3 hypnotherapy sessions. The investigators will compare the     groups using a validated overactive bladder questionnaire and compare voiding diaries to     evaluate urinary frequency at the end of the sessions/study completion.   "
225188|NCT00793624|"     The primary objective of this study is to assess the long-term efficacy and safety of once     daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat®     inhaler, in patients with COPD.   "
225189|NCT00793637|"     In many cases, the existing locking bolts and screws in intramedullary nails do not provide     sufficient stability. Due to the play between screw and nail, the reduction can be lost and     the instability can result in malunions, nonunions, or pseudoarthrosis. Consequently,     secondary angular fracture dislocation (defined as a difference of the angle of 10° or more     from the post-operative to the follow-up x-rays) can be observed in approximately 30% of     patients after conventional intramedullary nailing of proximal third tibial fractures and in     approximately 0-2% in patients with distal third tibial fractures. Therefore, an Angular     Stable Locking System for Intramedullary Nails (ASLS) was developed to reduce the risk of     secondary loss of reduction by providing axial and angular stability. ASLS provides angular     stable fixation between nails and screws with resorbable sleeves used as dowels in the nail     locking holes.      The present study evaluates the handling of ASLS and the surgeon's compliance as well as any     complications occurring during the baseline and the follow-up period in patients with     proximal and distal tibial, femoral and humeral fractures treated with intramedullary nails.     Furthermore, the relationship of any occurred complications to ASLS will be assessed.   "
225190|NCT00793650|"     The goal of this study is to evaluate the safety of melphalan and autologous PBSCT     (peripheral blood stem cell transplantation - stem cells that come from your own body) in     combination with bortezomib, a new FDA approved drug used to treat myeloma.   "
225193|NCT00787839|"     People who might have prediabetes or unrecognized diabetes will be screened for these     problems at an outpatient visit. For screening, they will take a sugary drink containing 50     grams of glucose, and have a blood sample one hour later. The blood sample will be tested for     glucose and A1c (a measure of blood glucose over the previous two months). They will also     fill out questionnaires that ask about their health history and how they would feel about     exercising and trying to lose weight if they are found to have prediabetes or diabetes. At a     subsequent visit, they will have an oral glucose tolerance test (OGTT) - a blood sample, then     a sugary drink containing 75 grams of glucose, and a repeat blood sample 2 hours later. We     will evaluate the costs of finding out if people have prediabetes or diabetes. For people who     are found to have these problems, we will also evaluate how well their doctors treat these     problems.   "
225194|NCT00787852|"     The purpose of this study is to evaluate if a maximum dose of 100 mg of dasatinib with     concurrent chemoradiation can be tolerated in patients with chemotherapy naive stage III     NSCLC in separate cohorts of locally advanced and potentially resectable disease.   "
225195|NCT00787865|"     This study is designed to learn about early brain development in children with Krabbe     disease, and to use diffusion tensor imaging as an early diagnostic tool to identify newborns     at risk for the disease.   "
225196|NCT00799539|"     The primary reason for this study is to further assess safety and efficacy data of the     bortezomib/melphalan/prednisone (BMP) regimen in previously untreated and transplant     ineligible multiple myeloma patients   "
225197|NCT00799552|"     The purpose of this study is to compare the safety and efficacy of RX-10045 to placebo for     the treatment of the signs and symptoms of dry eye.   "
225198|NCT00799565|"     This prospective nation-wide (France) study aims to search for susceptibility genes in MVP     using a genome wide analysis and comparing results obtained in 1000 patients with MVP and     1000 non-MVP subjects.   "
225200|NCT00799591|"     This study will describe clinical outcome and safety data collected prospectively in subjects     hospitalized in an intensive care unit (ICU) presenting with an infection for which treatment     with tigecycline, alone or in combination, is planned. Data will be collected only from     subjects providing informed consent.   "
225201|NCT00799604|"     This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of     clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of     blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and     pharmacokinetics of clevidipine after bolus administration.   "
225202|NCT00799617|"     The Testosterone Trials are a multi-center set of trials involving 12 clinical sites     geographically distributed across the United States.      The primary specific aims are to test the hypotheses that testosterone treatment of elderly     men whose serum testosterone concentrations are unequivocally low - and who have symptoms and     objectively measured abnormalities in at least one of five areas that could be due to low     testosterone (physical or sexual function, vitality, cognition, and anemia) - will result in     more favorable changes in those abnormalities than placebo treatment.      Two additional trials have been incorporated into the T Trial. Only men enrolled in the T     Trial are eligible to participate in these trials.        -  The Cardiovascular Trial will examine if testosterone treatment results in more          favorable changes in cardiovascular risk factors, compared to placebo.        -  The Bone Trial will test the hypothesis that testosterone treatment will increase          volumetric trabecular bone mineral density (vBMD) of the lumbar spine as measured by          quantitative computed tomography (QCT), compared with placebo treatment.      A Pharmacokinetic (PK) Study is also being conducted within the context of the interventional     T Trial. It will examine the variability of the serum testosterone (T) concentration after     application of testosterone gel or placebo, four months after the start of treatment.   "
225203|NCT00799630|"     Exercise has numerous health benefits. Nevertheless, when exercise duration is ~45 min or     longer and intensity moderate to intense, it may induce different troubles, for example:     hypoglycemia, peripheral and central fatigue, muscle damages, osteoarticular injuries,     inflammation, cardiovascular dysfunctions. Nutritional loading during exercise may prevent     and and/or reduce some of these troubles.      In regard of recent data, we proposed a novel energy drink (NUTRAPERF®) to limit deleterious     effects of long time exercise in neutral environment (outside temperature between 4 and 25°C)     and to improve performance. If performance may be increased by this energy drink during long     time exercise, we proposed that it consumption may also improve performance in short and     sub-maximal exercise.      So, the purpose of this study is to investigate the effects of the consumption of this novel     energy drink on performance during long and short time exercise. Moreover, we studied the     effects of this consumption on different metabolic parameters (heart rate, oxygen     consumption, respiratory quotient, ventilation, glycemia, lactatemia), on central and     peripheral fatigue and on cognitive parameters.   "
225204|NCT00799643|"     Growing evidence over recent years supports a potential role for low grade chronic     inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we     will determine whether salsalate, a member of the commonly used Non-Steroidal     Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2     diabetes. The study will determine whether salicylates represent a new pharmacological option     for diabetes management. The study is conducted in two stages. Enrollment in the first stage     is complete. The primary objective of the first stage was to select a dose of salsalate that     is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The     primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood     sugar control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes     (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and     cardiac risk.   "
225205|NCT00799656|"     The primary objective of this study is to assess the efficacy of ataciguat versus placebo in     reducing pain intensity in patients with neuropathic pain.      The secondary objective is to assess the safety and tolerability of ataciguat versus placebo.   "
225218|NCT00799825|"     This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV     vaccine GSK580299 in female subjects who took part in study 580299/008 and received the     control vaccine (Hepatitis A vaccine).   "
225207|NCT00799682|"     The purpose of this study is to determine if there is a difference in the ocular signs and     symptoms of subjects' eyes using Xalatan® 0.005% versus Travatan Z® 0.004% based on the     outcome of subject assessment and clinical assessment in patients with Ocular Hypertension or     Glaucoma with mild to moderate dry eye at baseline in accordance with the Oxford Grading     Scale.   "
225208|NCT00799695|"     Diabetic retinopathy is the major cause of blindness in working age Americans, and screening     for it is cost-effective. There are a quarter of a million people in Southeast Michigan with     diabetes and pre-diabetes.      Only half of patients with diabetes are screened regularly for diabetic retinopathy, and this     proportion has been difficult to increase despite various interventions. Previous research     focused on HMO patient groups because preventative care was thought to decrease plan costs.     In addition, it was administratively feasible to track patient-doctor interactions.      This project builds on published research and institutional experience to determine an     effective method for increasing the screening rate, in a mobile, non-HMO population. It uses     administrative methods and information technology infrastructures, such as large scale     electronic medical records and patient demographic databases, to identify existing patients     requiring examinations.      Patients were telephoned by a trained service representative who offered and scheduled firm     examination appointment times.      Hypothesis: Annual screening rates for diabetic retinopathy can be substantially improved in     non-HMO patient groups by directly contacting patients and scheduling firm appointment times.   "
225209|NCT00799708|"     This study will develop a model for the assessment of successful activation/engagement of     estrogen receptor beta using salivary biomarkers.   "
225227|NCT00800397|"     Medical literature has shown that 1 out of 2 patients that are admitted to the hospital as a     cardiac patient, will be found suffering from sleep breathing disorders. The medical     literature also shows that there is an advantage of treating the sleep breathing disorders in     addition to treating the cardiac disease or evaluating the heart failure condition to provide     better clinical outcomes.this study is evaluating the ability to detect sleep and cardiac     related breathing disordered.   "
225210|NCT00799721|"     VLBW infants are at risk of developing retinopathy of prematurity (ROP). In the first phase     of ROP there is a down-regulation of retinal VEGF-expression because of postnatal relative     hyperoxia, followed by an upregulation of VEGF mediated through retinal hypoxia, which leads     to pathologic vessel formation. VEGF acts through binding to the specific receptor FLT-1, the     soluble form sFLT-1 is a specific antagonist of VEGF action. Erythropoietin, given to VLBW     infants to prevent anemia, may stimulate VEGF-production in neuronal cells. Currently, there     are no data published about VEGF urine-levels in VLBW infants and it is not known, if urine     VEGF-levels may serve as a non-invasive marker of ROP-risk. Further shall be investigated, if     erythropoietin-therapy increases urine VEGF-levels and if there is a correlation with     ROP-development.   "
225211|NCT00799734|"     The objective of this study is to evaluate whether a Chinese medicine formula (Erxian     Decoction，EXD) is effective in alleviating menopausal symptoms, improving sex hormone profile     and bone turn-over.   "
225212|NCT00799747|"     The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when     given as single oral ascending doses to Japanese healthy male volunters. This will be done by     comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption,     distrubution and disappearance of AZD4017 in the body. Information about plasma     concentrations of AZD4017 vs time after dose intake will also be collected. The future     indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.   "
225213|NCT00799760|"     In order to prevent the high mortality due to an hypothetic pandemic caused by a newly     emerging influenza A virus, antiviral drugs are seen as essential requirements for control of     initial influenza outbreaks.Two antivirals are available for the treatment oseltamivir and     zanamivir. Emergence of Oseltamivir resistance has been recently reported. . It appeared     opportune to assess the efficacy and safety of biotherapy of neuraminidase inhibitors ,will     be investigated by a randomized, placebo controlled, double blind study in France, during the     next winter season . This study will be conducted in 300 centres of primary care with 900     adults with a virologically suspected influenza A infection. Individuals will be randomized     to 1 of the 3 treatment groups: oseltamivir +zanamivir, or oseltamivir+placebo or placebo     +zanamivir.The primary judgment criteria will be the proportion of patients with negative RT     PCR negative in nasal secretions at Day 2.   "
225214|NCT00799773|"     Thrombotic thrombocytopenic purpura (TTP) is a rare disorder that causes blood clots to form     in blood vessels. The main treatment for TTP is plasma exchange, in which affected patients     receive transfusions of plasma, the liquid part of blood, from healthy donors. This study     will examine the effectiveness of an antibody, rituximab, in combination with plasma     exchange, at improving the immune response in people with TTP and decreasing the recurrence     of TTP.   "
225215|NCT00799786|"     The workshop is a 6-week online workshop for caregivers of people with traumatic brain     injury, post traumatic stress disorder, or dementia. It is being conducted jointly by the     Stanford Patient Education Research Center and the VA Greater Los Angeles Healthcare System     and is supported by a grant from the Department of Veterans Affairs, Patient Care Services,     Office of Care Management and Social Work.      The goal of the study is to determine whether an online caregiver education and support     workshop can have lasting beneficial effects in helping caregivers improve their     self-management of health skills, stress, and improve their caregiving abilities.   "
225216|NCT00799799|"     AML patients with de-novo or secondary disease with age greater than 18 years not eligible     for stem cell transplantation for medical contraindications, lack of donor or lack of stem     cells,are eligible. Leukemias other than AML and M3 FAB subtype will be excluded from the     study. Immunosuppressive chemotherapy prior to NK cell infusion will include: fludarabine and     cyclophosphamide 4g/m2 (Flu/Cy). The therapy will be administered over 6 days on inpatient     basis. Haploidentical NK cells will be selected from a steady-state large volume     leukapheresis product from a suitable KIR ligand incompatible donor. Donor-recipients pairs     will be selected on the basis of known KIR ligands. In particular, haploidentical donors will     be included if present at least one allele mismatch at a class I locus among the following     ones: HLA-C alleles with Asn77-Lys80, HLA-C alleles with Ser77-Asn80, HLA-Bw4 alleles.     Immunomagnetic enrichment of NK cells will follow two subsequent steps: 1) depletion of CD3+     T cells followed by 2) positive selection of CD56+ NK cells. Contaminating CD3+ T cells will     be carefully evaluated.   "
225217|NCT00799812|"     Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3     swabsticks used one-at-a-time. Hibiclens applied according to the manufacturer's directions.     Sterile swabsticks (wetted with sterile water) applied using the same method as the     ChloraPrep Swabstick.   "
225221|NCT00799864|"     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the     drug), safety and effectiveness of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose     once daily in combination with an investigator-selected background regimen containing 2     nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine [AZT]/lamivudine [3TC] or     abacavir [ABC]/3TC) in antiretroviral (ARV) treatment.   "
225222|NCT00800332|"     The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve     allergy symptoms in patients with house dust mite allergy. The active treatment will be     compared against placebo.   "
225223|NCT00800345|"     This is a Phase 1, dose-escalation study in female patients with recurrent or persistent     gynecologic tumors.   "
225224|NCT00800358|"     The purpose of this study is to determine whether oral paricalcitol is safer and more     efficacious compared to oral calcitriol in the treatment of hyperparathyroidism in chronic     kidney disease patients undergoing dialysis.   "
225225|NCT00800371|"     Juvenile idiopathic arthritis (JIA) may progress asymptomatically leading to joint     destruction despite treatment.      The aim of the observational study is to describe patients with silent arthritis comparing     symptoms, clinical findings with results of ultrasound and magnetic resonance imaging (MRI).   "
225226|NCT00800384|"     This trial will assess the safety of defibrillator testing and the influence of     defibrillation testing on the efficacy of clinical shocks.      The trial will test the hypothesis that implantable cardioverter defibrillator (ICD)     implantation without defibrillation testing (DT) is non-inferior to implantation with testing     against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic     death.      It will also test the hypothesis, that defibrillation testing increases the peri-operative     (30 days) complication rate of ICD implantation.   "
225228|NCT00800410|"     The objectives of the proposed study are to determine whether culturally diverse community     residents with diabetes are willing to participate in our community health worker     intervention using randomized controlled trial (RCT) methods and to explore and document     effective processes and protocols for RCT methods in these communities. The investigators     will examine retention rates, identify reasons for attrition through interviews and focus     groups, and determine strategies for improving recruitment, retention, and intervention     methods. As a secondary objective, the investigators will explore the potential impacts of     the intervention for improving healthy lifestyles, diabetes self-management, and selected     health outcomes of participants.   "
225229|NCT00800423|"     Most patients undergoing cataract surgery suffer from corneal edema after the surgery.      Brimonidine drops are a well known and safe Anti-glaucoma medication. the investigators have     made several clinical observations that patients receiving Brimonidine drops had a faster     resolution of their corneal edema even if they had normal intra-ocular pressure.      The investigators believe that administering topical Brimonidine to patients with significant     post operative corneal edema will hasten the resolution of their corneal edema.   "
225230|NCT00800436|"     This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that     results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and     in HER2-positive female participants. The study will also assess the safety and tolerability     of the SC and IV formulations. In Part 1 of the study, four cohorts will be treated with a     single dose of Herceptin as follows: Cohort 1 (6 milligrams per kilogram [mg/kg] IV in     healthy male participants); Cohort 2 (6 mg/kg IV in HER2-positive female participants);     Cohort 3 (6 mg/kg SC in healthy male participants); Cohort 4 (10 mg/kg SC in healthy male     participants). An additional cohort of healthy volunteers (Cohort 5) will be opened if both     SC dose levels from Cohorts 3 and 4 result in Herceptin exposures different from the target     concentration produced by a single IV dose, or if the variability in pharmacokinetic (PK)     parameter values cannot be used to define the target SC dose level. In Part 2 of the study,     HER2-positive female participants will receive a single dose of SC Herceptin at the dose     level defined in Part 1. Participants from Part 1 are eligible to enter Part 2 provided they     receive the second (Part 2) study dose of Herceptin a minimum of 22 days after their first     (Part 1) dose.   "
225231|NCT00800449|"     The Haptoglobin (Hp) gene locus at chromosome 16q22 is polymorphic with two alleles denoted 1     and 2 .The gene product exists in three phenotypes: 1-1, 2-1, and 2-2.      The Haptoglobin 2 allele is found only in man and is believed to have arisen from the     Haptoglobin 1 allele by a partial intragenic duplication. Haptoglobin 2 allele frequency is     higher than the Haptoglobin 1 allele. It has been hypothesized that the Haptoglobin 2 allele     was spread in man due to its selective advantage against life-threatening infections.      In vitro, only the Haptoglobin 2 allele protein, binds to the streptococcus T antigen,     resulting in its aggregation and slowing its growth .      Individuals homozygous for the Haptoglobin 1 allele (1-1 genotype) are more prone to the     streptococcal infection than individuals with the Haptoglobin 2 allele(2-1 or 2-2 genotype).      The investigators wish to explore the linkage between Hp phenotype and sepsis in pre-term     neonates, considering that in this early stage in life, genetic properties which provide a     defense against infectious agents will be of heightened importance.   "
225232|NCT00800462|"     This is a phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and     safety of two M3 receptors antagonists (Trospium Chloride and Darifenacin Hydrobromide) with     one standard drug (Oxybutynin Chloride) for treatment of overactive bladder in individuals     with spinal cord injury.   "
225233|NCT00800475|"     The purpose of this study is to determine whether two oral formulations of Gemfibrozil     Tablets are bioequivalent.   "
225234|NCT00800488|"     The primary objective is to study the value of serum procalcitonin as a predictive marker for     severe bacterial infection in febrile infants.      2200 febrile infants aged less than 3 months will prospectively be included. All infants will     have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin     concentration in infants with and without serious Bacterial infection.      Evaluation of the area under the ROC for Procalcitonin concentration.   "
225235|NCT00800501|"     This study is conducted to evaluate the safety and tolerability of the drug product sNN0029,     containing the growth factor VEGF165, when administered directly into one of the fluid filled     cavities in the brain using an implanted catheter and an implanted SynchroMed® II pump.     Patients with Amyotrophic Lateral Sclerosis will be enrolled.   "
225236|NCT00800514|"     The study will explore the neurocognitive effect of four weeks of treatment with amantadine     versus placebo in patients with traumatic brain injury using the Interval Bisection Timing     Task. Approximately 16 individuals with traumatic brain injury are expected to participate in     this study. Subject participation is expected to last up to 8 weeks with 16 study visits.   "
225237|NCT00800527|"     In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with     diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the     patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain     syndromes.   "
225238|NCT00800540|"     The purpose of this study was to compare the short term effects of two intraocular pressure     (IOP) lowering medications on ocular perfusion pressure (OPP), ocular blood flow, intraocular     pressure, and blood pressure in patients with glaucoma. Ocular perfusion pressure (OPP) is     defined as the difference between arterial blood pressure (diastolic and systolic) and     intraocular pressure. The primary efficacy assessment is based on diastolic ocular perfusion     pressure.   "
225239|NCT00800553|"     The purpose of this study was to characterize how the anti-cholinesterase inhibitor (AChE-I)     donepezil modulates brain regions involved in visual short-term memory, episodic memory and     inhibitory efficiency following 24 hours of total sleep deprivation using fMRI as an     additional marker for drug effect.   "
225240|NCT00800566|"     The goal of this clinical research study is to find the highest tolerable dose of clofarabine     when given to patients with CLL. The safety of this drug will also be studied.   "
225241|NCT00800579|"     The purpose of this study is to evaluate the safety and tolerability of escalating doses of     GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore     airway hydration and mucociliary clearance in the lung.   "
225243|NCT00800605|"     The purpose of this study is to demonstrate the efficacy of an investigational Vero     cell-derived, trivalent, seasonal influenza vaccine to prevent infection with an influenza     virus that is antigenically similar to one of the three strains in the vaccine. Subjects will     be randomized in a double-blind fashion to receive a single intramuscular injection of either     the investigational vaccine or placebo. Blood will be drawn from all subjects for a     determination of hemagglutination inhibition antibody titers on Days 0 and 21, body     temperature and injection site reactions will be monitored daily for 7 days. In addition,     subjects must return to the clinic promptly to have swab samples of their nose and throat     taken whenever they feel flu symptoms and all subjects will be monitored for adverse events     until Day 180.   "
225244|NCT00800618|"     The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy     young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873     has on sex hormones in healthy young women   "
225245|NCT00800631|"     The development and severity of sepsis induced myocardial dysfunction can be monitored from     the serum biomarker.   "
225246|NCT00800644|"     The goal of this study is to estimate how often pelvic fractures occur in women treated with     radiation therapy for either newly diagnosed or recurrent cervical, endometrial, or vaginal     cancer. The study will also estimate the changes in bone mineral density and the changes in     the blood that relate to bone turnover. High bone turnover can weaken bones and make you     more likely to break a bone.   "
225247|NCT00800657|"     Same patients with dilated myocardiopathies with large areas of fibrosis has not been as     successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional     class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant     with Cardiac Resynchronization Therapy in these patients.   "
225248|NCT00800670|"     The purpose of this Phase 1 study is to evaluate the safety and immune responses of a new     tuberculosis vaccine, Ad5Ag85A, administered to healthy volunteers. 48 subjects will be     recruited, 24 who have previously been vaccinated with BCG and 24 who have not received BCG     vaccine. Two doses of the vaccine will be compared.   "
225249|NCT00800683|"     to determine safety, efficacy and tolerability of BI 1356 versus placebo   "
225250|NCT00800696|"     The purpose of the investigators project is to examine if the investigators may affect a     reduction in respiratory infections in a pediatric long term care facility by institution of     a comprehensive oral care program. The investigators wish to base their project on work such     as of Yoneyama et al 2002, which hypothesized and showed that silent aspiration of     oropharyngeal contents is a causative factor in development of respiratory infection in     elderly institutionalized clients. It was found that an advanced oral hygiene program greatly     reduced the incidence of respiratory infection. Although no similar research projects were     found to have involved children, the investigators hope that a similar program of oral care     will allow the investigators to likewise reduce the incidence of respiratory infection among     the pediatric clients in our facility.      The investigators propose to examine two groups of children which are fed by gastrostomy     feedings only. One group will continue to receive oral care as performed today. The study     group will have their teeth brushed three times a day by the nursing staff by using a suction     connected toothbrush, daily examination of the oropharynx by the nursing staff, and use of     chlorhexidine varnish or another suitable antibacterial agent in the oropharynx.      The investigators will retrospectively examine our records (a 12 month period) for febrile     days, antibiotic use and hospitalization days due to respiratory causes. The investigators     will then compare these to the febrile days, antibiotic use and hospitalizations to the 12     month period [post implementation of the oral care program.      The importance of this program is to examine whether by implementation of a relatively     inexpensive and low-tech intervention may meaningfully reduce the morbidity and mortality due     to respiratory infection among our clients (which from our experience is the main cause of     morbidity and mortality in the investigators institution). The investigators expect that by     reducing the incidence of respiratory disease among our clients that the investigators will     greatly reduce suffering among the children and their families, improve their quality of life     and ease the financial and organizational burdens as a result of caring for respiratory     infections.      As was noted before, no prior research was found which studied the pediatric population in a     long term care facilities. It is our belief that this project represents a unique research     opportunity which may bring great benefit to the children and caregivers.   "
225263|NCT00800865|"     A study to evaluate biomarkers of cancer (context-specific sensitizers) in the skin of     participants already receiving cytotoxic therapy. Additional blood and urine samples will be     collected for phosphorylated Histone 2AX (γH2AX) and renal toxicity biomarker testing,     respectively.   "
226096|NCT00813371|"     The early initiation of Airway Pressure Release Ventilation in multi-system trauma patients     decreases the incidence and severity of acute lung injury and Acute Respiratory Distress     Syndrome and allows faster recovery of lung function.   "
225251|NCT00800709|"     In AD, tau protein is abnormally hyperphosphorylated. Significant changes of     hyperphosphorylated tau levels in CSF are found in AD patients. It has been shown in vitro     that memantine can reverse abnormal hyperphosphorylation of tau in hippocampal neurons of     rats. A statistically significant reduction of CSF phosphorylated tau at a preliminary 1-year     follow-up was observed, from median 126 (interquartile range 107-153) to 108 (88-133) ng/l (p     = 0.018). No statistically significant differences of total tau or Aβ42 were found     (Gunnarsson MD, 2007).      FDG-PET has the unique ability to estimate the local cerebral metabolic rate of glucose     consumption, thus providing information on the distribution of neuronal death and synapse     dysfunction in AD in vivo (Herholz K. 2003). Synaptic dysfunction and loss induce a reduction     in neuronal energy demand that results in decreased glucose metabolism. Hypometabolism in AD     is thought to reflect loss of synaptic activity and density (Herholz K. 2003; Mielke R, et     al. 1998).      Another biological markers such as inflammatory factor and APOEε4 also play a part in the     onset of AD (Glodzik-Sobanska L, 2007).   "
225252|NCT00800722|"     The purpose of this study is to improve port wine stain therapeutic outcome in response to     laser therapy. The researchers want to determine whether the combined use of pulsed dye laser     therapy and rapamycin will improve PWS therapeutic outcome.   "
225253|NCT00800735|"     This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or     in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have     participated in a previous Roche or Roche partner protocol where access to treatment or     re-treatment was promised or deemed appropriate following completion of the original protocol     ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS     monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus,     800-1200 mg daily, as continuation of treatment after the wash-out period defined in their     donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48     weeks in genotype G1 with a treatment-free follow up period of 24 weeks.   "
225298|NCT00801333|"     Induced pluripotent stem cells potentially may be useful in the future as an unlimited source     of cells for transplantation.      The major goal of the project is to develop human iPS cells from various types of cell     cultures or lines from existing collections. The IPS cells will be developed for modeling     diseases, for developing the technology that may eventually allow the use of IPS cells for     transplantation therapy, and for basic research.   "
225254|NCT00800748|"     This 3-arm study assessed the safety and efficacy of combination treatment with peginterferon     alfa-2a + ribavirin in participants with chronic hepatitis C. Three groups of participants     were studied; 1) those with elevated alanine transaminase (ALT) levels, 2) those with normal     ALT levels, and 3) those with human immunodeficiency virus (HIV) co-infection. Participants     with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous     (SC) once weekly (qw) + ribavirin 1000-1200 milligrams (mg) orally (PO) daily (dependent on     body weight) for 48 weeks. Those with genotype 2 or 3 received peginterferon alfa-2a 180 mcg     SC qw + ribavirin 800 mg PO daily for 24 weeks, and all participants with HIV co-infection     received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.   "
225255|NCT00800761|"     Myocardial iron overload is the leading cause of death in patients with beta-thalassemia     major (TM). Therapy with deferoxamine (DFO) combined with deferiprone (DFP) reduces     myocardial iron and improves cardiac function. However, the prognosis for TM patients with     established cardiac disease switched from DFO monotherapy to combined DFP/DFO chelation is     unknown. Twenty-eight TM patients with cardiac disease were enrolled in a prospective study     lasting 42±6 months. Fifteen (9 high-ferritin and 6 low-ferritin) were placed on DFP/DFO     (DFP, 75 mg/kg t.i.d.; DFO, 40-50 mg/kg over 8-12 h at night 5-7 d/wk), while 13 (5 high- and     8 low-ferritin) received DFO alone. No cardiac events were observed among high-ferritin     patients on combination therapy, whereas 4 cardiac events (p=0.0049), including three deaths,     occurred in high-ferritin patients on DFO monotherapy. These findings demonstrate that in TM     patients with well-established cardiac disease combined iron-chelation therapy with DFP/DFO     is superior to DFO monotherapy.   "
225256|NCT00800774|"     The purpose of this study is to determine the safety, efficacy, predictability, and stability     of laser in situ keratomileusis (LASIK) to correct high anisometropia in patients 8 to 15     years old in whom conventional treatments have failed.   "
225257|NCT00800787|"     A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB,     administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who     underwent liver transplantation.   "
225258|NCT00800800|"     The purpose of this study is to assess the effects of rosuvastatin compared to usual care in     patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to     moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering     agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year     recruitment period, and a treatment duration of a minimum of 3 years from the time of the     last patient randomized to a maximum of 5 years.   "
225259|NCT00800813|"     Some men complain of changes in the shape or dimensions of their penis after undergoing     radical prostatectomy (removal of the prostate) for prostate cancer. Changes in penile     dimensions include shortening or decreased girth. Changes in shape include a curvature or     bending of the penis, and/or the appearance of indentation. These changes may be associated     with formation of scar tissue involving the covering of the erection chambers, known as     plaque. The appearance of indurated plaque and a resultant curvature or indentation is a     well described medical condition known as Peyronie's Disease and may occur in men who did     or did not undergo radical prostatectomy. The purpose of this study is to evaluate these     changes in penile shape and dimensions.   "
225260|NCT00800826|"     This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine     mixture for intravenous patient-controlled analgesia (PCA).   "
225261|NCT00800839|"     The goal of this clinical research study is to learn if cyclophosphamide given after busulfan     and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which     transplanted tissue attacks the body into which it is transplanted) in patients receiving a     stem cell transplant. The safety of this drug combination will also be studied.   "
225262|NCT00800852|"     The inflammatory process is involved in the pathogenesis of obesity. Prader-Willi syndrome     (PWS) is a genetic model of syndromic obesity. Adiponectin is an adipokine with potent     anti-inflammatory properties, and its effect is mediated through adiponectin receptors 1     (adipoR1) and 2 (adipoR2).      Objective of this study is to compare the expression of adipoR1, adipoR2, and adiponectin in     peripheral blood mononuclear cells (PBMCs) in PWS children and obese control and to correlate     receptor expression with insulin sensitivity and obesity-related parameters.   "
225264|NCT00800878|"     The Indo-Asian developing countries are facing an epidemic of chronic diseases including     hypertension, diabetes and chronic kidney disease (CKD). Diagnosis of early CKD is essential     for institution of effective and timely prevention of its complications; costly late stage     treatment for end stage renal disease is currently an unfeasible option in these populations.     GFR estimates of kidney function provide a common reference standard for all people and are     therefore readily applicable by physicians and understood by patients. However, the existing     GFR equations yield widely discrepant results in the Indo Asian population, and none of the     currently available estimating equations have been validated in this population.      The main objective is to develop a tool which can be used for screening subjects at high risk     for developing CKD (with hypertension and diabetes) as well as the general population.   "
225265|NCT00800904|"     The purpose of this study is to determine the percentage of patients who has reached the GINA     guideline of asthma treatment after receiving any inhaled corticosteroid for 3 months or     longer in actual clinical practice. Such percentage for each level of severity - mild,     moderate and severe persistent asthma as well as the differences of these rates will also be     explored.   "
225266|NCT00800917|"     This trial is an investigator initiated, open label phase II study, where patient with     recurrent primary GBM will be considered for the study. Only patients with recurrence after     Temozolomide and VEGF-directed therapy with Bevacizumab will be considered for the study.     Patients will receive temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15 and 22 and     bevacizumab 10 mg/kg IV over 30-90 minutes on day 8 and 22. Treatment repeats every 28 days     for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. A     safety analysis will be performed when the first 10 patients have received minimum 4 cycles     (8 weeks). The study will then be stopped:      If DLT is observed in > 2/10 patients, Occurrence of any serious adverse events not described     in the SPC of each agents, If partial remission is not observed in at least 1/10 patients   "
246711|NCT01080911|"     This study aims to compare the effect of spinal morphine between the dose 0.05 mg and 0.1 mg     on the amount of morphine during the first 24 hours postoperative.   "
225267|NCT00800930|"     Shigellosis is one of the major causes of morbidity and mortality in many developing     countries. The continued emergence of antibiotic resistant strains has complicated the     treatment of shigellosis and has increased the cost of treatment markedly. Antimicrobial     peptides are considered as endogenous antibiotic. A mixture of these antimicrobial peptides     (LL-37 and beta-defensin) drenches the mucosal epithelial surfaces forming a barrier for     invading microorganisms. Recently, we found that Shigella down-regulates the expression of     LL-37 and beta-defensin 1 (HBD-1) in the colon of patients during acute shigellosis thereby     facilitating bacterial invasion. Both LL-37 and HBD-1 could inhibit the growth of various     microbes e.g. S. dysenteriae type 1, S. flexneri, and S. boydii. Our study indicated that     bacterial DNA might be a potential mediator for the down- regulation in vitro.     Down-regulation of LL-37 and HBD-1 was also seen in watery diarrhea caused by other     pathogens. Thus, bacteria-mediated down-regulation of our front line defenses could be one     strategy evolved by the pathogens to subvert this host-defense mechanism. gene encoding LL-37     in cultured epithelial cell lines were up-regulated when treated with butyrate; butyrate     decreased the severity of Shigella infections in rabbit model. We could reproduce our     findings from human i.e. downregulation of CAP-18 (the rabbit homologue to human LL-37) in     colon epithelia after infection with Shigella flexneri. CAP-18 reappeared after treatment of     the infected rabbits with sodium butyrate. Thus, the rabbit model demonstrated the proof of     principal. In this study, we aim to assess the efficacy of sodium butyrate enema in reduction     of clinical symptoms and / severity, reduction of inflammatory responses and induction of     endogenous antibiotic activity in the rectum in adult patients with shigellosis.   "
225268|NCT00800943|"     To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to     chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in     patients who have achieved a complete remission (CR) or b) convert partial remission to     complete remission.      To evaluate the time-to-progression of patients according to pretreatment characteristics and     response status at study entry.      To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to     chemotherapy will eliminate minimal residual disease as determined by real-time quantitative     PCR.   "
225269|NCT00800956|"     The purpose of the study is to learn more about how esreboxetine is handled by the body i.e.     the absorption, metabolism and excretion of esreboxetine.   "
225270|NCT00800969|"     This prospective study includes patients with histologically proven cancer of the     esophagogastric junction (Siewert Type II and III) and the stomach. Aim of the study is to     evaluate the accuracy of PET-CT for the preoperative assessment of lymph node metastasis. The     evaluation includes a combination with standard diagnostic tools (endoluminal ultrasound, CT     and diagnostic laparoscopy prior to neoadjuvant therapy). Standardized D2-lymphadenectomy is     performed and individual lymph node stations (Nr 1-12 according to the Japanese     classification) are histopathologically examined. Furthermore we evaluate the role of the     PET-CT for early metabolic response evaluation in patients receiving neoadjuvant     chemotherapy.        -  Trial with surgical intervention   "
225271|NCT00800982|"     This is a single-center, open-label, pilot study. A total of 30 subjects (15 in each study     arm) will be enrolled in this 6 month study to evaluate whether the addition of narrow band     UVB (NB-UVB) phototherapy can enhance the efficacy of etanercept's maintenance dose, 50 mg     once a week, in obese psoriasis patients.   "
225272|NCT00800995|"     INTRODUCTION:      Acting directly on the anti-radical enzyme chain, the superoxide dismutase (SOD), a major     enzyme of the anti-oxidant system, provides an alternative of the antioxidants treatment in     ARMD. Its synthesis depends on the cellular oxygenated reactive species, and leads to the     conversion of the superoxide ion (O2-) into hydrogen peroxide (H2O2). This compound is the     cell watch guard continuously regulating a free radicals' detoxifying chain. Subsequently, by     increasing the production of H2O2, the administration of SOD can trigger endogenous/internal     antioxidant mechanisms.      Oral administration of SOD is possible in its galenic form, Glisodine. The purpose of this     study was to evaluate the protective effect of SOD on the bilateralization of the disease.   "
225273|NCT00801008|"     The purpose of this study is to develop an exercise and relaxation program for young adults     (age 18 to 39) who have completed their treatment for cancer.   "
225274|NCT00801021|"     The purpose of the study is to determine the effect of an investigational oral rinse in     reducing uropathogens and treating uncomplicated urinary tract infections.   "
225275|NCT00801034|"     In humans living of fruit and vegetables, hypertension is rarely seen. We wish to study if     the development of hypertension has a connection to our intake of potassium. We know that     fruit and vegetables contain a lot of potassium and we will simulate this intake by giving     healthy subjects potassium as tablets.   "
225276|NCT00801047|"     Women requesting analgesia do not always wish to receive a potent analgesic method, and may     fear the risks of epidural analgesia.      Study Aim: To determine whether remifentanil is effective for labor analgesia when compared     with standard treatment (epidural analgesia).   "
225279|NCT00801086|"     Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can     contribute to the distress and social isolation of patients with advanced cancer. In this     study a topical gel will be applied directly to the scalp during each dose of radiotherapy.     The goal is to determine to what extent the experimental drug is successful in lessening the     hair loss.   "
225280|NCT00801099|"     In a rural hospital in Tanzania the rate of surgical site infections (SSI) was 21.6%.     Inappropriate choice of antibiotics and of administration time were determined as sole risk     factors in this setting. After implementation of a standardized procedure with a single shot     dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively the rate of SSI     dropped by 80% in spite of procedural risk factors like poor hygiene etc.   "
225292|NCT00801255|"     This 7 cohort study will evaluate the efficacy and safety of combination treatment with an     HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease     inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, genotype     1.Cohorts A,B,C,D and G will be treatment-naive patients, cohort E will be     treatment-experienced excluding null responders, and cohort F will be null responders.     Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591,     alone or in combination, for up to 7 or 14 days. Cohort C will evaluate combination treatment     with either 1000mg po bid RO5024048 and 100mg q8h RO5190591 or 500mg po bid RO5024048 and     200mg q8h RO5190591 for 14 days. Cohort D will evaluate 1000mg po bid RO5024048 and 200mg q8h     RO5190591 for 14 days.Cohort E will evaluate 1000mg RO5024048/600mg RO5190591 po twice daily     for 14 days, and Cohorts F and G will evaluate 1000mg RO5024048/900mg RO5190591 po twice     daily for 14 days. Cohorts will be tested sequentially or in parallel, if supported by     appropriate safety and pharmacokinetic data.Following the last dose of study medication     patients have the option of continuing treatment with Standard of care therapies. The     anticipated time on study treatment is <3 months, and the target sample size is <100     individuals.   "
225281|NCT00801112|"     Hypothesis: The investigators hypothesize that regular monitoring of BIA adds value to the     management of fluid status in PD patients      Objectives of the study: The objective is to show that in patients where the additional     information of body composition is available to the clinician that the ECFv is maintained     within pre-agreed limits, ~ 1 liter, over the observation period of 12 months.      SCIENTIFIC BACKGROUND:      Low peritoneal ultrafiltration, and by inference low sodium removal, is associated with worse     outcomes in PD. Equally, excessive fluid removal is a risk factor for dehydration and loss of     residual renal function. Current guidelines have advocated a daily UF volume of 1litre; their     blunt application could lead to either inappropriate early loss of residual function or     modality transfer. There is a significant need for evidence on how to best manage fluid     status in PD patients, both in terms of an appropriate clinical strategy and also a simple     but reproducible tool to guide clinicians in how to apply this strategy.      It is likely that BIA will become the standard tool to aid clinicians in assessing fluid     status. It is simple to perform, intervention studies have demonstrated its ability to     identify changes in fluid status in response to changes in therapy and it is a powerful     predictor of patient survival. There is, however a clear need at this stage for proof of     principle studies to establish its true potential for added value in the routine management     of patients.      Body composition changes spontaneously with time on PD. Short term changes in hydration     (specifically extracellular fluid volume, ECFv) combined with medium term changes in muscle     and fat make it difficult for the clinician to be sure if fluid status is stable. It is     anticipated that regular BIA measurements will aid the clinician in managing this problem     over and above monitoring of weight and fluid status. By randomizing patients into two groups     who have regular BIA measurements, one of which the BIA data is available to the clinician it     will be possible to see if these spontaneous changes in body composition can be accounted     for.   "
225282|NCT00801125|"     The purpose of this study is to demonstrate the safety, tolerability and clinical benefit of     TYSABRI® (natalizumab) in patients with moderately to severely active Crohn's disease.   "
225283|NCT00801138|"     This study will test the hypothesis that adding dexamethasone significantly prolongs the     duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect     differs among the two local anaesthetics.. Participants will be patients undergoing shoulder     surgery with an interscalene nerve block.   "
225284|NCT00801151|"     This is a multi-center, open-label non-randomized dose-escalation trial of vorinostat given     in combination with vinorelbine. Cohorts will be treated with a fixed dose of vinorelbine     (25mg/m²/week continuously, representing the schedule that has been approved). Patients     eligible will be enrolled into a standard 3+3 design with a starting dose of vorinostat at     200 mg po qd 7/21 (weekly schedule). Then, further dose levels will be explored. Toxicity of     the schedule will be assessed during the first cycle. Patients may receive up to 6 cycles of     study medication. Blood samples will be collected at specified time points to assess     pharmacokinetic endpoints.   "
225285|NCT00801164|"     The goals of this exploratory study are to 1)examine an investigational oral rinse as an     adjunctive agent to scaling and root planing in treating chronic periodontitis in a     periodontitis-susceptible diabetes population, and 2) evaluate its effect on glycemic control     and biomarkers of systemic inflammation.   "
225286|NCT00801177|"     The purpose of this study is to determine if IMC-11F8 is safe for patients, and also to     determine the best dose of IMC-11F8 to give to patients.   "
225287|NCT00801190|"     The overall aim of this study is to determine if there is a bleeding risk associated with the     use of starch-containing fluids during cardiac surgery. The specific purpose of this study     will be to examine, in a prospective randomized double-blind placebo-controlled fashion, the     effects of colloid (HES 130/0.4) vs. crystalloid (Ringer's Lactate) on bleeding in patients     undergoing cardiopulmonary bypass for cardiac surgery. The primary end point of this trial     will be chest tube output at 24 hours. In addition, a range of secondary end points focusing     on transfusion parameters, as well as other important end-organ outcomes, will be determined.   "
225288|NCT00801203|"     This study is to evaluate the effectiveness of identifying stress urinary incontinence (SUI)     in female subjects using the Induced Reflex Cough Test (IRCT) administered with urodynamic     testing by evaluation of sensitivity and specificity.   "
225289|NCT00801216|"     This prospective trial will assess the activity and feasibility of a new high-dose     methotrexate-based high-dose sequential chemotherapy combination in patients with B-cell     lymphomas and CNS involvement at diagnosis or relapse. Selected drugs, with a well-documented     anti-lymphoma activity, will be administered at high doses to increase blood-brain barrier     penetration and CNS bioavailability as well as to reduce potential cross-resistance.   "
225290|NCT00801229|"     The primary objective of the study is to assess the benefice of Vyvanse on the factors that     cause impairments in driving behavior in individuals with ADHD using a driving simulation     aimed at examining the factors that cause impairments in driving behavior in individuals with     ADHD such as driving speed, collision risk, and visual attention of 60 young drivers (ages     18-24) with ADHD. We hypothesize: 1.) young adults with ADHD treated with Vyvanse will show     lower velocity (speed) scores and spend less time driving over the posted speed limit in the     driving simulation when compared to subjects taking a placebo; 2.) young adults with ADHD     treated with Vyvanse will show a lesser likelihood to collide with a suddenly appearing     peripheral object, less difficulty maintaining the vehicle within their lane, and a lesser     likelihood of driving through stop signs and solid red traffic lights without slowing down     when compared to subjects taking a placebo; and 3.) young adults with ADHD treated with     Vyvanse will exhibit more focused visual attention on details in the visual field when     compared to subjects taking a placebo while driving. In addition, young adults with ADHD     treated with Vyvanse will exhibit less visual tunneling and shorter off-road glances when     compared to subjects taking a placebo.   "
225291|NCT00801242|"     The purpose of this uncontrolled, multi-center, open-label trial was to investigate the     feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the     treatment of prostate cancer.   "
226097|NCT00813384|"     First in human, open-label, sequential dose escalation and expansion study of AMG 208 in     subjects with advanced solid tumors.   "
225293|NCT00801268|"     Triptolide has been approve effective in animal model.   "
225294|NCT00801281|"     Evaluation of event free survival (EFS) of patients treated with the study chemotherapy     induction program: R-CHOP compared to the standard R-CVP regimen and response rates, time to     best response, PFS, OS, neutropenic fever rate, infection rate, change in Ig levels, change     in lymphocyte subpopulations counts in previously untreated indolent lymphoma patients in     need of systemic treatment.   "
225295|NCT00801294|"     The primary objective of this trial is to explore the overall objective best response rate     and the rate of non-progression at 16 weeks of sequential, alternating weekly administration     of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria.   "
225299|NCT00801346|"     RATIONALE: Gathering information about metabolic syndrome from young patients with acute     lymphoblastic leukemia may help doctors learn more about the disease.      PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute     lymphoblastic leukemia in remission.   "
225300|NCT00801359|"     Two intraocular irrigating solutions (BSSPlus versus Lactated Ringer's) are compared in this     prospective, randomized, masked trial to investigate for differences in preservation of     corneal integrity after phacoemulsification cataract surgery.   "
225301|NCT00801372|"     Induced pluripotent stem cells potentially may be useful in the future as an unlimited source     of cells for transplantation.      The major goal of the project is to develop human iPS cells from existing lines of     fibroblasts that were originally donated as clinical grade feeders for the development of     clinical grade hESCs. The clinical grade feeders were developed from aborted fetuses,     foreskin and umbilical cord.   "
225302|NCT00801385|"     RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Sorafenib may also stop the growth of non-small cell lung     cancer by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill     more tumor cells.      PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib     works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has     not responded to chemotherapy.   "
225303|NCT00801398|"     When post-operative parenteral analgesia is discontinued, oral dosing with study medication     may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS     (pain intensity score greater than or equal to 40).   "
225304|NCT00801411|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, docetaxel, and doxorubicin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving combination chemotherapy before surgery may make the     tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet     known which chemotherapy regimen is more effective in treating breast cancer.      PURPOSE: This randomized phase II trial is studying cyclophosphamide given together with     docetaxel to see how well it works compared with cyclophosphamide given together with     doxorubicin in treating women with newly diagnosed breast cancer that can be removed by     surgery.   "
225305|NCT00801424|"     Eighty adult patients undergoing open colon surgery will be randomized to either:        1. standard warming measures including heating sheets, warming of fluids, and insulation of          limbs and head, or to        2. additional insufflation of humidified carbon dioxide (approx. 36-37ºC, approx. 80-100%          relative humidity) via a humidifier with a heated tube (Fisher&Paykel) connected to a          gas diffuser (Cardia Innovation AB) that is able to create a local atmosphere of 100%          carbon dioxide (humidified ) in the open wound cavity.      PRIMARY AIM The primary aim of this study is to evaluate if humidified carbon dioxide     insufflated into an open surgical wound can be used to warm the core, the open wound cavity,     and the wound edges during major abdominal surgery.      SECONDARY AIMS Secondary aims are to evaluate possible differences between the groups     regarding complications and clinical differences including histological signs of desiccation     injury of peritoneal samples, time to extubation, core temperature after surgery, ICU stay,     bleeding volume, hospital stay, postoperative pain, infections, shivering, postoperative     signs of restored bowel function including bowel movements, flatus, and first meal.   "
225306|NCT00801437|"     This study is designed to evaluate the safety and tolerability of Xalacom in patients with     primary glaucoma   "
226098|NCT00813397|"     This study will examine the performance of SeprasSpray in patients undergoing abdominal     surgery (laparoscopic).   "
225307|NCT00801450|"     Triamcinolone has already been used by different routes of administration to treat diabetic     macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's     infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in     eyes with refractory diffuse diabetic macular edema are tested.   "
225308|NCT00801463|"     The purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii     in treated Focal Segmental Glomerulosclerosis (FSGS).   "
225309|NCT00801476|"     Young women with breast cancer have an increased breast tissue density and conventional     imaging tests such as mammography and breast ultrasound are less sensitive and specific for     detecting breast cancer than in older breast cancer patients. Breast MRI is an emerging tool     that has been proven to improve the ability to identify breast cancers by determining the     extent of disease and also detect multifocal, multicentric and bilateral breast cancers. To     date, the role of pre-operative breast MRI is not clearly defined. The investigators are     proposing a study to evaluate the impact of preoperative breast MRI on surgical     decision-making in breast cancer patients <= 50 years. This may lead to improved     characterization of breast cancers in these younger patients that may ultimately result in     lower local recurrence rates in the future. The additional information attained through the     breast MRI may also guide the use of radiation, chemotherapy and/or hormonal therapy in these     patients.   "
225310|NCT00801489|"     The goal of this clinical research study is to learn if idarubicin can be added to the     combination of fludarabine, cytarabine, and Neupogen (Filgrastim) without increasing the risk     of side effects. This study will also look at whether the addition of idarubicin will     increase the long-term chances of patients remaining disease free.   "
225311|NCT00801502|"     The number of infants and children with allergic disease (dermatitis, allergies, asthma) has     increased over the last several decades. This may be related to changes in diet. It is now     thought that children become sensitised to allergens very early in life maybe even before     they are born. Some studies show that a high omega-3 fat intake by mothers decreases risk of     sensitisation in their babies. There is a biological mechanism to explain this. Omega-3 fats     are found in oily fish like salmon. In the UK pregnant women are recommended to eat oily fish     twice per week. However, consumption of oily fish is known to be low in pregnant women in the     UK. This study sets out to identify the effects of increasing salmon intake in pregnant     women. The hypothesis being investigated is that : increased consumption of oily fish during     pregnancy by women at risk of having offspring who will develop atopy will increase their     omega-3 fat and antioxidant status and that of their developing baby and will ameliorate the     development of atopic markers and manifestations in the infants.   "
225312|NCT00801515|"     This is a compassionate study to provide continued access to maraviroc for only those     subjects completing study A4001029 who are showing clinical benefit. Assessments of safety     and tolerability of maraviroc when added to OBT will be continued.   "
225313|NCT00801528|"     A prospective, randomized, double blind study designed to investigate analgesic efficacy of     wound infusion using diclofenac or ropivacaine following Cesarean section performed via a     Pfannenstiel incision.   "
225314|NCT00801541|"     To this study and identify the sequence of alterations occurring in the chorioretinal     interface during progression of AMD from dry AMD to sight-threatening chorioretinal     neovascularization (CNV).   "
225315|NCT00801554|"     The overarching aim of the study is to characterize children and adults with ASDs, and     compare them with age-matched controls in relation to their functioning in family, academic,     employment, and social spheres. Subjects will be comprehensively assessed in multiple     non-overlapping domains of functioning, using psychiatric, cognitive, and psychosocial     instruments.   "
225316|NCT00801567|"     This study aims to gather additional information to support the theory that bipolar disorder     is due to cellular (mitochondrial) dysfunction. To test this theory adults with bipolar     disorder who are not currently symptomatic will receive a one-time brain scan (magnetic     resonance spectroscopy [MRS] scan) with light stimulation. To test whether any MRS findings     are specific to bipolar disorder, healthy controls and adults with schizophrenia will also be     included in this study.   "
225317|NCT00801580|"     The patient receive 2 different drug combinations on this study. The first combination will     consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate,     doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The     second combination will consist of another intensive chemotherapy regimen (methotrexate and     Ara-C [cytarabine]).   "
225318|NCT00801593|"     Children with juvenile idiopathic arthritis (JIA) suffer in up to 87% of the cases of     arthritis of the temporomandibular joints (TMJs). Magnetic resonance imaging (MRI) is the     only modality for the early diagnosis of TMJ involvement.      Aim of the study is to compare symptoms and clinical findings with MRI and ultrasonography     results and to describe the action of the current medication on the arthritis of the TMJs.   "
225319|NCT00801606|"     A recent trial in adults has demonstrated that zinc (Zn) and other Multiminerals (MN)     combined, but neither of them alone, significantly increased weight gain during Tuberculosis     (TB) treatment. There was a substantially larger beneficial effect on survival amongst those     who received the combination of Zn and MN compared with those who received either Zn alone or     MN alone. These exciting preliminary findings require further confirmation, as the data on     mortality reduction was based on a post-hoc subgroup-analysis. Effects of MN and Zn     supplementation has not been assessed in children with TB. Studies are urgently needed to     evaluate the therapeutic potential of nutritional interventions on treatment outcome in     children with TB. Simple and inexpensive nutritional interventions may substantially impact     TB-related child morbidity and mortality in high-burden settings. The investigators thus,     propose a randomized, double blind, controlled trial that will measure the effect of     multi-vitamin/mineral supplementation on the efficacy of anti-TB treatment in newly diagnosed     childhood pulmonary TB patients in Delhi.   "
225320|NCT00801619|"     We will use information technology to integrate the 2004 American Academy of Pediatrics     guidelines for management of neonatal hyperbilirubinemia with laboratory reporting of newborn     bilirubin test results to improve physician adherence to the guidelines and quality of care.   "
226099|NCT00813410|"     The study seeks to use microdialysis and microperfusion techniques to assess the feasibility     of performing insulin delivery and glucose sensing at a single subcutaneous tissue site.   "
225321|NCT00801632|"     In small initial studies, combined kidney and bone marrow transplants from the same donor     have permitted some individuals to stop taking anti-rejection medicines without rejecting     their transplant. This clinical trial will study this method in a greater number of people to     determine if it is indeed effective and safe.   "
225322|NCT00801645|"     The main purpose of this project is to investigate the effects of an exercise program on     arterial function and cardiovascular diseases risk factors in obese and lean pre-pubertal     children. This information will be used to underpin prevention strategies to reduce     cardiovascular diseases in overweight youth.   "
225323|NCT00801658|"     Examination and follow-up of efficacy and safety of SLT in patients with unsufficient IOP     control despite maximum tolerated topical therapy. In addition, it will be examined whether     medical treatment can be reduced after the SLT procedure and whether filtering surgery - as     the only remaining option - may be postponed.   "
225324|NCT00801671|"     The purpose of this study is to determine whether CPAP is effective in the treatment of     systemic hypertension.   "
225325|NCT00801684|"     The purpose of this study was to evaluate the efficacy, safety, and tolerability of single     doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive     pulmonary disease (COPD).   "
225326|NCT00801697|"     This study will evaluate the safety and preliminary immune response to recombinant adenoviral     serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.   "
225327|NCT00801710|"     This study is to determine if the BridgePoint Medical System (CrossBoss Catheter, Stingray     Catheter, Entera Guidewire) can facilitate safe and effective placement of a guidewire in the     true lumen of coronary vessels distal to a chronic total occlusion (CTO).      The hypothesis is that the BridgePoint Medical System can do this without an increase in     major complications.   "
225341|NCT00801905|"     The purpose of this study is to determine whether topical nepafenac (qid) is effective in     preventing and treating macular thickening related pan-retinal photocoagulation in patients     with diabetic retinopathy.   "
225342|NCT00801918|"     The purpose of this study is to determine is Denileukin diftitox will be safe, well tolerated     and induce a significant overall response alone and in combination with chemotherapy:     ifosfamide, carboplatin and etoposide (ICE) and will be safe and well tolerated in a     population of children, adolescents and young adults with relapsed or refractory anaplastic     large cell lymphoma (ALCL).   "
225343|NCT00801931|"     Double umbilical cord blood transplantation (DUCBT) following high dose or reduced intensity     conditioning will be well-tolerated and result in a high degree of engraftment in patients     with selected malignant and non-malignant disorders.   "
225328|NCT00801723|"     Randomized, double-blind, comparative study versus placebo performed in patients from studies     CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who     achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of     treatment.      Patients in remission at the End of Study visit will be given the opportunity to enter the     12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study     visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will     be no interruption of study treatment between the parent studies and this study.      It is planned that approximately 150 patients will be enrolled in the study. Patients will be     randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective     of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a     day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical     relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and     stool frequency ≥ 1-2 stools/day above normal for the patient (score ≥ 1 in both UCDAI     items).      During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1,     3, 6, 9, and 12 months of treatment.      Patients will be contacted by telephone on a monthly basis for safety assessment. In case of     occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled     visit at any time during the study.   "
225329|NCT00801736|"     Lung cancer is the leading cause of cancer death in the UK, leading to 34 000 deaths each     year (22% of cancer deaths). Non-small cell lung cancer (NSCLC) is the most common histology,     accounting for approximately 80% of cases and most present with advanced, stage IIIb or IV     disease. The recommended treatment for advanced disease is a doublet platinum-based     chemotherapy, although the survival benefits are modest. Even among those fit enough for     chemotherapy, the response rate is only 20-40%, and median survival averages 9-10 months with     the newer platinum-containing chemotherapy regimen (Schiller et al, 2002; Rudd et al, 2005;     Lee et al, 2007). Only 11% of patients went on to survive 2 years when treated with the newer     gemcitabine/carboplatin regimen established by the London Lung Cancer Group (Rudd et al,     2005; Lee et al, 2007). New strategies are needed to further improve the prognosis of this     disease.   "
225330|NCT00801749|"     Sleep relate to cognitive function.   "
225331|NCT00801762|"     The goal of the study is to develop a novel approach to obtain real time optical biopsy of     urinary tract pathology (e.g., bladder tumors) during urinary tract endoscopy using a novel     fibered confocal microscope.   "
225332|NCT00801775|"     The purpose of this study is to analyze whether calorimetry compared to conventional methods     (i.e.blood culture systems)is superior to diagnose peritoneal dialysis related peritonitis.   "
225333|NCT00801788|"     The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet®     oxycodone formulations and compare to a marketed oxycodone product.   "
225334|NCT00801801|"     The purpose of this study is to assess the 2-month progression-free survival in patients with     advanced or metastatic, non-squamous cell lung cancer treated with weekly low dose docetaxel     in combination with a biologic dose of sorafenib.   "
225335|NCT00801814|"     To determine palatability and extent to which escalating doses of a novel highly viscous     polysaccharide [NVP] reduces postprandial glycemia when added to a liquid and a solid meal.   "
225336|NCT00801827|"     The purpose of this study is to look at certain areas of the brain that are related to     addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors'     (DRD2/3) and other studies have shown that obese people have less of these. We propose that     low DRD2/3 availability seen in morbidly obese subjects will change with weight loss     associated with bariatric surgery.   "
225337|NCT00801853|"     A multi-center, Phase IIb, double-blind, randomized, placebo controlled, parallel-group,     repeated-dose study in male and female patients with moderate to severe asthma in which     patients will be stabilized on AEROVANT then doses of inhaled corticosteroids and LABA will     be tapered. The hypothesis is that AEROVANT will improve asthma symptom control and decrease     the need for inhaled corticosteroids and LABA, thus improving exacerbation incidence compared     to placebo. Incidence of asthma exacerbation is the primary endpoint.   "
225338|NCT00801866|"     to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg),     against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance     in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative     diabetic retinopathy (PDR) and good vision   "
225339|NCT00801879|"     Staphylococcus aureus is a bacteria that causes serious, often life threatening infections     including pneumonia, wound, and bloodstream infections. Persons with AIDS are at high risk     for S. aureus infections. They are also at high risk for nasal carriage of S. aureus. In     fact, nasal carriage is a known risk factor for subsequent S. aureus infection. Topical     mupirocin, an antibiotic when applied to the anterior nares, is a safe, effective way to     eliminate S. aureus colonization. Some studies have shown that mupirocin can also decrease     the risk of S. aureus infection, but many of those studies utilized historical controls and     none were rigorously tested among AIDS patients over an extended period of time.      The main purpose of this randomized, double-blinded, placebo controlled study is to determine     if mupirocin can eliminate S. aureus nasal colonization in residents at PSI (inpatient, drug     rehabilitation facility for AIDS patients in the Bronx.) PSI residents currently have a high     incidence of S. aureus nasal colonization and infection. Nasal cultures followed by twice     daily application of mupirocin vs. placebo for five days will be performed on a monthly basis     for 8 months. the study will examine whether mupirocin decreases the incidence of S. aureus     infections and prevents S. aureus nasal colonization. The study is important because it may     show that mupirocin is an effective way to eliminate nasal colonization and prevent S. aureus     infections in AIDS patients, among those at highest risk for serious S. aureus infection.      Hypothesis: Monthly application of mupirocin will reduce nasal colonization with S.aureus   "
225340|NCT00801892|"     Daily physical activity is important to achieve glucose control in persons with type 2     diabetes. The purpose of this study is to explore if obstructive sleep apnea and its daytime     symptom, excessive sleepiness, act as barriers to physical activity. We will examine if     treatment of obstructive sleep apnea with continuous positive airway pressure results in     increased physical activity in persons with type 2 diabetes.   "
225347|NCT00801983|"     Awkward postures during computer keyboard use have been hypothesized to be one cause of     musculoskeletal pain/discomfort as well as musculoskeletal disorders of the upper extremity     (MSD-UE). Alternative computer keyboards purport to reduce musculoskeletal pain/discomfort     and have been shown to change aspects of keyboard users' kinematics under laboratory     conditions. However, research that has examined the effectiveness of alternative keyboards in     reducing musculoskeletal pain/discomfort in the workplace is equivocal, and no study has     examined the association between postures and musculoskeletal pain. The Aims of this 3-year     prospective double cross-over trial are: 1) To examine the effectiveness of an alternative     keyboard in reducing reports of pain over 6-months; 2) To examine the neutrality and     stability of postures during keyboard use; and 3) To identify which postures are associated     with lower levels of musculoskeletal pain. Seventy-five computer users will be randomly     assigned to one of two keyboard use orders: Group 1 - AB (standard keyboard, alternative     keyboard); Group 2 - BA (alternative keyboard, standard keyboard). All subjects will use     their assigned keyboards for 6-months before switching to the next keyboard. Every week,     subjects will report their musculoskeletal pain levels. Just prior to and just after each     6-month intervention subjects' kinematics performances on the keyboards will be recorded at     the worksite using the Keyboard - Personal Computing Style (K-PeCS) instrument and in a     laboratory setting using 3-dimensional motion capture technology.      Aim 1: To examine the effectiveness of an alternative keyboard in reducing pain over     6-months.      Hypothesis 1 (H-1) - At six months subjects using an alternative keyboard will have     significantly lower musculoskeletal pain levels than when using a standard keyboard.      Aim 2: To examine the neutrality and stability of postures during keyboard use.      Hypothesis 3 (H-2) - Subjects using an alternative keyboard will have significantly more     neutral postures than when using a standard keyboard at baseline and at 6 months Hypothesis 3     (H-3) - Subjects 6-months keyboarding postures will remain equivalent to the keyboarding     postures documented at baseline.   "
225348|NCT00801996|"     This protocol is designed to collect a small amount of blood and tissue from individuals with     prostate cancer for extraction of DNA (genetic material) for the study of the genetic basis     of prostate cancer. The study population will include individuals with known prostate cancer     and controls without prostate cancer. The study will be conducted in Doha, Qatar at the Hamad     Medical Corporation and Weill Cornell Medical College (Qatar). Individuals in the study     population will be of Arab descent from Qatar. In this protocol, researchers will survey     epidemiologic factors and medical records of patients with prostate cancer in order to study     the clinical characteristics of these individuals. The researchers will collect blood and     tissue samples to evaluate the genetic characteristics of individuals with prostate cancer.     The researchers will also collect blood samples of individuals without prostate cancer to     serve as a control. The goal will be to identify genes that are associated with prostate     cancer and gene profiles that are associated with differing prognoses in individuals who have     prostate cancer.   "
225349|NCT00802009|"     Patients undergoing surgery of the hand often are treated with a nerve block in the     shoulder/neck area that provides anesthesia/numbing during surgery. Nerve blocks usually last     for a few hours after surgery and provide pain relief for this period. It may be possible to     extend the duration of anesthesia by using a steroid, which has anti-inflammtory properties.     This study will compare the duration of the nerve block when dexamethasone (steroid) is added     to the anesthetic injected around the nerve.   "
225363|NCT00802191|"     Purpose of the study:      The purpose of this study is to investigate the Wii remote game control device for use in the     study of Movement Disorders. The term Movement Disorders refers to a group of abnormal     medical conditions characterized by involuntary body movements. Current treatment of these     disorders is primarily geared to improve symptoms. Rating scales are usually used to grade     response to treatment. These rating scales require special training, take a lot of time, and     often present with great variability. Thus, the development of a simple device to perform     efficacy measurements offers a great advantage over current methods and is less costly.   "
225350|NCT00802022|"     Rationale: Diabetic neuropathy is one of the most common complications of Diabetes Mellitis     (DM). Pain is a common symptom of diabetic neuropathy, affecting 11-34% of patients suffering     form DM. The current available medication often provides insufficient pain relief and/or has     unacceptable side effects. Spinal cord stimulation (SCS) has been used for over 30 years to     treat neuropathic pain. Various small clinical studies have shown a beneficial effect of SCS     on pain in PDP.      Objective: This study is a preparation to a RCT to investigate whether SCS is a good     indication in patients which suffer from pain with moderate-to-severe PDP in the lower limbs.     The main objective of this study is whether SCS leads to sufficient pain relief and to obtain     insight into the working mechanism of SCS. The hypothesis is that the effect SCS is most     effective in patients without major sensory deficits. Furthermore, practical feasibility of     the test procedures described in the study protocol will be examined, including the     questionnaires to be filled out by the patient. Also, technical feasibility of SCS will be     investigated. Besides the feasibility, the possibility of predicting successful pain relief     by SCS by classifying patients according to the Michigan Diabetic Neuropathy Score will be     assessed. Furthermore, possible other predictors for successful pain relief by SCS will be     defined. Study design: the study is a pilot study in preparation to a RCT to investigate the     effect of spinal cord stimulation on pain in moderate-to-severe PDP patients.      Study population: patients suffering from moderate-to-severe PDP in the lower limbs as     diagnosed by clinical symptoms and supported by the Michigan Diabetic Neuropathy Score.      Intervention: patients will receive 2 weeks of trial stimulation and best (drug) treatment as     usual.      Main study parameters/endpoints: Main study parameter is the pain score as measured by a     numeric rating scale (NRS) according to Jensen and a Patient Global Impression of Change for     pain measured on a 7-point Likert scale.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: SCS related risks include: lead migration (14%), lead breakage (7%), implanted     pulse generator migration (1%), loss of therapeutic effect, lost or unpleasant paresthesias     (12%), infection or wound breakdown (10%), Pain at IPG incision site (12%), IPG pocket fluid     collection (5%).   "
225351|NCT00802035|"     The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of     different baclofen formulations.   "
225352|NCT00802048|"     Cardiac surgery often induces acute postoperative pain and moreover chronic dysesthesia     frequently occur long-term after sternotomy. The high doses of intraoperative opioïds are     well known to enhance postoperative hyperalgesia (HA) and a perioperative local anesthetic     agent infusion is one of the therapeutic strategies used to limit this phenomena. The aim of     this study was to evaluate the effectiveness of a continuous Ropivacaïne sternal infusion     compared with a saline serum infusion to limit postoperative HA, pain and morphine     consumption (M) after sternotomy in cardiac surgery.      This strategy could lead to lower postoperative morphine consumption and opioïd induced     hyperalgesia.   "
225353|NCT00802061|"     This study is designed to investigate the effect of body posture (particularly when sleeping)     on the pressure in the eye. The effect of body posture on progressive glaucoma (glaucoma     where a significant change i.e. a disc hemorrhage has occurred) is not known.      The study will involve being admitted to the Sleep Unit of the University Health Network at     Toronto Western Hospital for 1 night (14 hours). IOP will be measured in both eyes every 2     hours with a Tonopen, along with brachial blood pressure (BP), in the sitting position until     the patients reach their normal sleep cycle time. Patients will then be asked to sleep in     either lying down or reclining at a 30 degrees position and have the IOP measurements and     brachial BP every 2 hours in that position.      The same cohort of patients will then be invited for a repeat 14 hour IOP and BP measurement     but will change their position, i.e. sitting before will now be supine and vice versa.   "
225384|NCT00802464|"     The goal of this randomized observer-blind trial is to further refine the formulation of     vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune     responses and the safety profiles of the different formulations.   "
225354|NCT00802074|"     To date, no study has investigated whether there is a drug interaction between the protease     inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL112775 is a randomized,     open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir     (APV) and raltegravir (RTG) pharmacokinetics in 48 healthy, fasting, HIV-negative adults     after administration of a 7-day regimen of RTG 400mg BID alone and after 14-day regimens of     unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/RTV 100mg BID, or FPV     1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent RTG 400mg BID. Blood     samples for drug concentration measurement will be collected over 12 hours at the end of each     dosing period. Subjects will undergo a physical examination, complete blood count (CBC) with     differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and     lipid panel at screening, and all of these tests, except those for HIV and hepatitis B/C,     will be repeated at follow-up post-study. Adverse events and adherence (by pill count and     medication diary) will be assessed by the investigator/study personnel at the end of each     dosing period   "
225355|NCT00802087|"     The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet®     hydrocodone formulations and compare to a marketed hydrocodone drug.   "
225356|NCT00802100|"     This study will compare the safety and effectiveness of three different antipsychotic     medications, as well as the use of other medications to limit treatment side effects, in     adults with schizophrenia.   "
225357|NCT00802113|"     The sequential combination of myeloablative therapy and autologous stem cell transplantation     (APBSCT) followed by a reduced intensity allogeneic stem cell transplant (Allo SCT) and post     SCT adoptive cellular immunotherapy will be well tolerated in patients with refractory or     recurrent non-Hodgkin's lymphoma (NHL) and Hodgkin's disease (HD).   "
225358|NCT00802126|"     The purpose of this study is to report the treatment effect and safety of combined     intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin using a     reduced (RF) light fluence rate, in choroidal neovascularization (CNV) secondary to     pathologic myopia.   "
225359|NCT00802139|"     multi-center, prospective, randomized, open-labeled, active-drug-controlled,     two-parallel-group-comparison(venoferrun group vs Bolgre group)study   "
225360|NCT00802152|"     In-home health monitoring devices have the potential to increase the speed and ease of     modifying treatment for ambulatory patients living with chronic conditions. This study     examines the implementation and effectiveness of remote data transmission from in-home     devices (blood glucose meter/blood pressure machine) to the clinic on treatment outcomes in     patients with diabetes who have out of range blood glucose (BG) or systolic blood pressure     (BP) measurements. We test whether the short-term targeted use of in-home monitoring devices     facilitates management for providers and improves outcome measures for patients.   "
225361|NCT00802165|"     This study is designed to evaluate whether or not electroacupuncture can have an effect on     the pain threshold of the subject, as compared to sham treatment.   "
225362|NCT00802178|"     In this study information is gathered about the treatment of Parkinson patients who present     themselves in a neurological practice for the first time   "
225523|NCT00803452|"     This prospective, randomized, comparative clinical trial evaluates the effect of either oral     doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of     the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease.   "
225364|NCT00802204|"     Obese individuals have fewer striatal dopamine type 2 receptors (DRD2) than normal weight     individuals. Lower DRD2 levels are associated with addiction and a decreased sense of     pleasure.Obesity is also associated with insulin resistance (poor insulin action).We propose     that insulin resistance and low DRD2 are associated. Using PET imaging,we aim to determine     DRD2 binding potential (BP) in the brain is associated with insulin resistance and     neuroendocrine hormone levels. Obese participants will be compared to lean, gender and age     similar participants. We also aim to determine the effect of caloric restriction on DRD2 BP     in obese subjects   "
225365|NCT00802217|"     Safety and pharmacokinetic first-time-in-human study of orally administered civamide in     healthy subjects.   "
225366|NCT00802230|"     Metoprolol succinate is a beta1-selective beta-blocker, becoming non-selective at higher     doses, while carvedilol is non-selective. We examined whether metoprolol remained     beta1-selective compared to carvedilol during dose up-titration in Class C heart failure (HF)     Beta-blocker naïve patients.      METHODS: Twenty-five NYHA FC II-III HF patients were randomized to carvedilol or metoprolol.     Patients were studied at baseline and after 2 weeks of up-titration (metoprolol at 25, 50,     100, and 200 mg daily; carvedilol IR at 3.125, 6.25, 12.5, 25 mg and 50mg twice daily).     Beta2- blockade was determined by an infusion of terbutaline at 6 mg/kg over 1 hour. Glucose     and potassium levels were serially measured at baseline, every 15 minutes for the 1st hour     and 30 minutes for 2nd hour post-infusion. The median area under the curve (AUC) for glucose     and potassium changes were calculated.   "
225367|NCT00802243|"     Bullous pemphigoid (BP) is the most common blistering auto-immune disease of skin with an     incidence estimated to 400 new cases per year. Topical corticosteroid therapy is considered     the standard treatment for bullous pemphigoïd in 2002. Topical corticosteroid requires an     initial large hospitalization during the acute phase and rehospitalization during relapse.     The usefulness of immunosuppressive drugs have suggested by uncontrolled study.      In this way, leflunomide could be an alternative therapy, and to reduce relapse and/or     resistance risks.      This study could prove the efficacity of leflunomide, associated with short time topical     corticosteroids.   "
225368|NCT00802256|"     A new Endodontic Cement (NEC) is being compared with mineral trioxide aggregate in pulpotomy     of primary molars.   "
225369|NCT00802269|"     The used of reduced fluence parameters for panretinal photocoagulation decreases pain as     perceived by the patient, compared to traditional parameters.   "
225385|NCT00802477|"     The purpose of this study is to determine if the application of autologous (your own blood)     blood products during mastectomy improves wound healing and decreases complications following     surgery compared to mastectomy without the use of autologous blood products.   "
225386|NCT00802490|"     The aim of this study is to investigate if electroencephalogram (EEG) biofeedback     incorporating the use of video games is effective in improving inattentive symptoms in     children with ADHD.   "
225370|NCT00802282|"     This study will investigate the effects of psilocybin dose and the frequency and intensity of     support activities for spiritual practice (e.g., meditation) on a battery of attitudinal and     behavioral outcome measures in 75 healthy volunteers who are interested in pursuing a program     of spiritual practices with the intention applying spiritual insights and knowledge to     everyday life. After screening and study enrollment, each volunteer will be assigned to one     of five groups that vary in dose, frequency and intensity of support for spiritual practice,     and number of psilocybin sessions (either 2 or 3 sessions). The psilocybin dose manipulation     will be double-blind. Volunteers will be told that in each of sessions 1, 2, and 3, he/she     could receive a very low, low, moderate, moderately high, or high dose of psilocybin. They     will be told that each participant will receive 2 or more dose levels of psilocybin over the     2 or 3 sessions, and all participants will have one or more sessions in which he or she     receives a moderately high or high dose of psilocybin. The duration of each volunteer's     participation will be approximately 6 to 8 months. Each volunteer will receive several hours     of preparation with the study guides in the month prior to the first psilocybin session; the     first two sessions will be separated by one month. Various measures will be assessed before,     during and immediately after sessions. A battery of longitudinal measures will be evaluated     immediately after study enrollment, 3 weeks after the second psilocybin session, and 4 months     after the second psilocybin session (6 months after study enrollment). For purposes of     controlling expectancies through the 6 month follow-up evaluation, volunteers and guides will     not know which volunteers or how many volunteers will be scheduled for a third session.   "
225371|NCT00802295|"     Our working hypothesis is that patients undergoing in vitro fertilization (IVF) with higher     response to ovarian stimulation protocols recover a higher number of oocytes and, this     elevated response could be translated into increased incidence of chromosomally abnormal     embryos. Our objective is to develop a prospective study on healthy young donors, with a     previous cycle with high ovarian response (>20 oocytes and/or E2 levels the day of the hCG     injection >3000 pg/mL), but without developing mild or severe hyperstimulation syndrome.     After signing a proper written consent, these donors would agree to undergo two subsequent     stimulation cycles following two different protocols. In one cycle the stimulation pattern     would be similar to the previous one, with elevated response and, in another cycle the amount     of gonadotropins would be cut down in order to obtain lower ovarian response. Oocytes     obtained in each cycle would be donated to anonymous recipients and after fertilization,     embryo quality and chromosomal status of the resulting embryos would be evaluated.     Preimplantation genetic diagnosis (PGD) will be performed on day-3 embryos and chromosomes     13, 15, 16, 17, 18, 21, 22, X and Y would be analyzed by fluorescence in situ hybridization     (FISH).   "
225372|NCT00802308|"     The purpose of the study is to evaluate the pharmacokinetics of Egalet® morphine when     administered with alcohol and compare to administration with water.   "
225373|NCT00802321|"     To monitor the inhibition of 5a-reductase (5AR) enzyme activity at 1, 3, 7, 14, 21, 28 and 42     days following administration of a single dose of dutasteride (2, 3, or 4 mg) by measuring     the change in blood levels of 3a-androstanediol glucuronide (3a-diolG) and the ratio of     dihydrotestosterone (DHT) to testosterone. To accomplish this aim, an open-label,     between-subjects dose comparison study design will be employed with subjects receiving a 2,     3, or 4 mg dosage. Subjects (up to n=40 enrolled to allow a minimum of 24 completers) will be     randomly assigned to one of the 3 dose levels. Results of this study will inform the dose     selection for a subsequent placebo-controlled, within-subject, crossover study of dutasteride     on the effects of alcohol.      A secondary aim of this study is to examine the correlation of a genetic variation in the     type I 5AR gene and baseline DHT/T ratio and effect of dutasteride at day 3. A variation in     this gene which is one of the targets of dutasteride has been reported to be associated with     higher baseline levels of DHT.   "
225374|NCT00802334|"     Evaluating the bioavailibility safety and efficacy of the generic LPV/RTV 200/50 mg tablet     formulation in a 400/100 mg BID dose in Thai HIV infected individuals.   "
225375|NCT00802347|"     The purpose of this study is to determine whether a single administration of QPI-1002 (also     known as I5NP) can prevent DGF in patients undergoing deceased donor kidney transplantation.     In this Phase I /II study, patients who are undergoing renal transplantation with organs from     DCD donors, ECD donors or SCD donors with ≥ 24 hours of cold ischemia time who meet study     entry criteria will be studied to evaluate the safety and pharmacokinetic profile of I5NP     (Part A) and clinical activity of I5NP administration (Part B). Data from this study will be     used to identify doses of I5NP to be used in follow-on efficacy studies.      Part A will be a randomized, dose escalation study to determine the highest or maximum     tolerated dose (MTD). Part A will enroll 40 patients at approximately 20 sites; patients will     be randomized to receive either I5NP or placebo in a ratio of 8:2 in each cohort (cohorts     1-4).      Part B will utilize the dose identified in Part A to further evaluate, in a double-blind     manner, the safety, and clinical activity of I5NP. In Part B, up to 326 patients will     participate at approximately 60 sites; up to 163 patients will be randomized to receive I5NP     and up to 163 patients randomized to receive placebo.   "
225376|NCT00802360|"     To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of     follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone     (GnRH) antagonist in vitro fertilization (IVF) cycles   "
225377|NCT00802373|"     Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen     for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB     symptoms by patient diaries.   "
225378|NCT00802386|"     A number of studies have shown a higher prevalence of BV among IUD users.13,,14 None,     however, have screened women prior to inserting the IUD. No data exists detailing the status     of the vaginal microflora and possible cervical infection prior to IUD insertion. Thus, no     inference can be made about the possible influence of IUD insertion and presence to the     development of upper genital tract infection . Consequently, with the current literature, it     would be difficult to make an argument for screening and treatment for BV prior to IUD     insertion. This study will help us determine whether women with an IUD develop a change in     the normal bacteria that are present in the vagina, known as bacterial vaginosis (BV). In     addition, in those women with BV, we are looking to see if they develop more significant     problems with the IUD, than those who do not have BV. Overall, this will help us determine     whether all women should be screened for BV prior to IUD insertion.   "
225387|NCT00802503|"     Rationale: Enteral nutrition (EN) in the intensive care (ICU) patients is recommended as a     standard of care. However, EN alone is often associated with insufficient energy intakes and     increased complication rates. Recently the investigators proposed to decrease this deficit by     combining EN and supplemental parenteral nutrition (SPN) whenever EN is insufficient (< 60%     of their predicted energy needs) at day 3 after admission in the ICU.      Objective: This study aims at: a/ investigating if the delivery of optimal nutrition support     (100 % of predicted energy targets) in ICU patients by the combined administration of SPN and     EN optimizes their clinical outcome; b/ implementing the new ICU nutrition guidelines.      Study design: Prospective, controlled, randomized clinical study.      Study site: Service of Intensive Care, Geneva University Hospital.      Patient population: 220 ICU patients to be included: expected length of stay > 5 days,     expected survival > 7 days, no contraindication to EN, obtained informed consent from     themselves or their next of keen.      Exclusion criteria: refusal of consent, age < 18 years, short bowel syndrome, significant     persistent gastrointestinal dysfunction with ileus, high output proximal fistula (> 1,5     liter/d), patients receiving PN.      Nutrition: At day 3 after admission, if energy input is < 60%; patients are randomized into     either the Control group (EN alone) or the SPN group (EN + PN) to reach 100% of their     predicted energy needs. Tight glycaemic control (target 6.0 to 8.3 mmol/l) to be achieved     according to our local practice by insulin administration.      Study endpoints:        -  Primary: nosocomial infections (CDC criteria)        -  Secondary: Mechanical ventilation duration, ICU and hospital length of stay, antibiotic          free days, ICU complications (extra-renal epuration, neurological, cardiac and          respiratory complications), energy and protein balance, 28 days clinical outcome.   "
225403|NCT00802711|"     RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy,     that delivers a high dose of radiation directly to the tumor may kill more tumor cells and     cause less damage to normal tissue. Internal radiation uses radioactive material placed     directly into or near a tumor to kill tumor cells. Giving these treatments after surgery may     kill any tumor cells that remain after surgery. It is not yet known whether 3-dimensional     conformal radiation therapy is more effective than internal radiation therapy when given     after surgery in treating early-stage breast cancer.      PURPOSE: This randomized phase II trial is studying 3-dimensional conformal radiation therapy     to see how well it works compared with internal radiation therapy when given after     breast-conserving surgery in treating women with stage I or stage II breast cancer.   "
225415|NCT00790803|"     According to a recent estimate more than 280,000 people in the United States are affected by     uveitis each year. This report, also estimated that uveitis is the reason for 30,000 new     cases of blindness/year and up to 10 percent of all cases of blindness. The purpose of this     trial is to determine the effectiveness of VEGF blockade with intravitreal pegaptanib in     patients with uveitic CME.   "
225388|NCT00802516|"     BACKGROUND Plant sterols and stanols are compounds that are structurally related to     cholesterol, which decrease intestinal cholesterol absorption and consequently serum LDL     cholesterol concentrations by 10-14%. Nowadays plant sterols and stanols are widely available     incorporated in food products like margarines and yogurts and are presented as functional     foods.      Whether the cholesterol lowering effects of plant sterols and stanols also favorably affect     endothelial function in humans is currently unknown. Apart from their cholesterol lowering     effects, plant sterols and stanols might have other effects like effects on red blood cell     properties, cognitive performance and antioxidant status. Especially to evaluate effects on     this type of parameters long-term daily consumption of plant sterols and stanols is     necessary. These questions will be answered in statin treated patients since functional foods     enriched with plant sterol and stanol esters have been recommended for statin-users as an     add on therapy. This may ultimately lead to a lower dose of statins or an increased number     of patients that reach the target for LDL-cholesterol reduction.      AIM The major objective of the present proposal is to examine the effects of a long-term     consumption of plant sterols and stanols on the endothelial function of the vessel wall in     statin-treated patients.      STUDY DESIGN Subjects: The subjects will be recruited among men and women in Maastricht and     surroundings, aged between 18 and 70 years. Participation will be on voluntary basis. People     who are willing to participate will be invited for two screening visits.      Experimental design: The present study is a double-blind, randomized parallel intervention     trial with 60 statin-treated subjects, in which the metabolic effects of a long term (90     weeks) consumption of plant sterols and stanols (2.5 g/day) will be studied. After a run-in     period of 5 weeks the subjects will be randomly divided into three groups of 20 subjects     each. One group will continue with the control margarine without added plant sterols and     stanols, one group will use a plant sterol margarine and the last group will use a plant     stanol margarine for 85 weeks. The major endpoint will be endothelial function of the vessel     wall, and in addition various parameters related to lipids and lipoprotein metabolism,     erythrocyte characteristics and cognitive performance will be measured.      Risk for subjects The margarines containing the plant sterols and stanols are safe and     palatable. Venipunctures and other (non-invasive) measurements are carried out by skilled     persons and not of any risk. A subject will spend approximately 1 hour a month in     participating in the studies.   "
225389|NCT00802529|"     This trial aims to compare transtympanic steroids against the standard treatment     (transtympanic gentamicin) in refractory unilateral Meniere's disease.   "
225390|NCT00802542|"     The purpose of this study is to prove in practice the effectiveness of Atacand 16 mg in     reducing blood pressure after 4 weeks of administration and the importance of administration     of adequate doses   "
225391|NCT00802555|"     Multi-center, single-arm Phase 1b study designed to evaluate safety and tolerability of ARQ     197 in cirrhotic patients with HCC.   "
225392|NCT00802568|"     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop     the growth of cancer cells. It also stops the patient's immune system from rejecting the     donor's stem cells. The donated stem cells may replace the patient's immune cells and help     destroy any remaining cancer cells (graft-versus-tumor effect).      PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with     busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how     well it works in treating patients with multiple myeloma that has not responded to treatment.   "
225393|NCT00802581|"     Current practices when performing any peripheral nerve block may or may not involve ensuring     circumferential spread of local anesthetic around the nerve. Ensuring circumferential spread     can involve several redirections of the needle above and below the nerve, and potentially     could result in either more discomfort for the patient or an increased chance of inadvertent     direct trauma to the nerve. Not ensuring spread around the nerve may result in a slower and     less complete blockade. The investigators suspect that by ensuring complete spread around the     nerve, the speed of block onset would be quicker because it avoids the loss due to diffusion     time.   "
225394|NCT00802594|"     Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the     last decade, and in many places the demand largely surpasses the capacities of the treatment     centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be     administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There     are currently no drugs which might be used as a tool to support disease control that is     easily administered and has low toxicity.      This study aims to assess the efficacy of DB289, a new, oral drug for treatment of first     stage sleeping sickness. The project will be executed in the framework of an international     consortium consisting of more than a dozen partners from academia, industry, and the     Ministries of Health of Angola and the Democratic Republic of Congo.   "
225395|NCT00802607|"     This study will collect bone, cartilage, tendon, ligament, skin and fat tissue from patients     undergoing surgery at Children's National Medical Center in Washington,   "
225399|NCT00802659|"     This study will evaluate pain control and quality of life in patients with paraspinal     metastases, who have receive previous radiation therapy to these lesions, using single dose     stereotactic radiotherapy.   "
225400|NCT00802672|"     The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox     Olamine Cream (Test Product) and Ciclopirox Cream 0.77% (Reference Product) in the treatment     of subjects with tinea pedis, and to show the superiority of the active treatments over that     of the vehicle.   "
225401|NCT00802685|"     The investigators propose the present study with the following aims:        -  to determine whether early patent ductus arteriosus (PDA) treatment with ibuprofen          treatment at the onset of clinical symptoms is superior to late ibuprofen treatment only          when symptoms of a hemodynamically significant PDA are present in the evolution of          bronchopulmonary dysplasia (BPD) defined as duration of supplemental oxygen exposure          during the first 28 days        -  to determine whether early PDA treatment with ibuprofen will be superior to late          treatment with ibuprofen in efficacy of PDA closure, need for rescue therapy, need for          PDA ligation and incidence of major complications of prematurity.      Hypothesis: Early pharmacologic closure of PDA with ibuprofen will improve respiratory course     and reduce BPD as reflected by a reduction in duration of supplemental oxygen during the     first 28 days of age vs. late pharmacologic treatment with ibuprofen.      Outcome variables: The primary outcome of this study is the number of days spent on     supplemental oxygen by each infant during the first 28 days.      Other outcomes to be determined between groups include:        -  Mortality        -  Other respiratory variables: total days on supplemental oxygen, days on mechanical          ventilation, oxygen dependence at 36 weeks post menstrual age, age at final extubation.        -  Other respiratory complications: pneumothorax, pulmonary interstitial emphysema, need          for high frequency ventilation, pulmonary hypertension        -  Efficacy of PDA closure: number of courses of medication required, need for ligation        -  Other neonatal complications: intraventricular hemorrhage (IVH), periventricular          leukomalacia (PVL), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC),          intestinal perforation, sepsis, renal dysfunction (oliguria, elevated creatinine)        -  Time to achieving full enteral feedings, time to regain birth weight, weight at          discharge.        -  Length of hospital stay   "
225402|NCT00802698|"     The purpose of this study is to describe the effect of transcorneal electrical stimulation     (TES) with a non conventional biphasic bipolar waveform in central retinal artery occlusion   "
225404|NCT00802724|"     The primary purpose of this proposal is to conduct a prospective, randomized, controlled     clinical trial to examine whether or not treatment based on a person's direction-specific,     impairment-based LBP classification is more effective than Non-specific treatment in     improving short- (6 weeks) and long-term (6 and 12 months) outcomes in people with chronic     LBP. We hypothesize that treatment based on a person's direction-specific, impairment-based     LBP classification (Classification-specific) will result in better outcomes than Non-specific     treatment. Our approach to classification-directed treatment is based on the proposal that a     person's LBP is the result of adopting direction-specific strategies of movement and     alignment of the spine which then are used repeatedly during the person's everyday     activities. The exposure of spine tissue to repeated loading in the same direction across a     day is proposed to accelerate the accumulation of stress, microtrauma, and eventually LBP. We     also hypothesize that until the factors contributing to the use of the direction-specific     strategies of the spine are modified, the LBP problem will persist or recur. Identification     of homogeneous subgroups of people with LBP will enhance 1) the power of clinical trials, 2)     prognosis, and 3) the ability to identify mechanisms contributing to different LBP problems.   "
225405|NCT00802737|"     The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment     and maintenance in patients with chronic lymphocytic leukemia who have previously responded     or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406).   "
225406|NCT00802763|"     This study was designed to validate the color appearance on the newly developed panty liner     (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into     contact with vaginal secretion with an elevated pH level, without false positives due to     urine remains or incontinence. The study will also asses the physical comfort in using     NORMA-SENSE and the result reading clarity which includes the ability to visualize and     interpret the NORMA-SENSE strip results.   "
225407|NCT00802776|"     Penetrating keratoplasty (PKP) is corneal transplantation performed by using round trephine     blades to create matched circumferential incisions in both the diseased cornea and the donor     cornea. The donor tissue graft is then secured in place with sutures which are usually     removed postoperatively.The primary surgical goals are the preservation of a clear graft and     improvement of vision. Surgical outcomes are limited by donor-recipient junction mismatch,     astigmatism, rejection, infection and wound dehiscence.      The femtosecond laser is a focusable, infrared laser capable of cutting tissue at various     depths and in a range of patterns, and is currently being used to create corneal lamellar     flaps in LASIK surgery. The laser parameters can be adjusted for submicron precision in     cutting desired diameters, depths and shapes in the cornea, with minimal collateral injury.     This technology is now capable of creating full-thickness corneal trephinations with     customized locking edges at the graft-host junction between the donor and recipient corneas     in Femtosecond Laser-Assisted Keratoplasty (FLAK). This approach may allow for better wound     junction of the donor and recipient corneas, which in turn may also significantly reduce     astigmatism, improve wound healing and visual recovery.      This pilot study will help us determine optimal femtosecond laser spot size, separation,     fluence, and energy which result in the best graft-host fit.      The specific aim is to investigate postoperative physiology and biomechanics after FLAK in     human eyes.   "
225408|NCT00802789|"     Treatment of patients insufficiently treated with ICS or ICS + LABA.   "
225409|NCT00802802|"     Efavirenz (EFV) is an anti-HIV medicine that is commonly used to treat HIV infection in     adults and children older than 3 years of age. This study is being conducted to look at the     safety of EFV, blood levels of EFV, genetic factors that may affect blood levels of EFV, and     how easy it is for infants and young children to take and tolerate EFV. This information will     help recommend the best doses of EFV for children younger than 3 years of age.   "
225410|NCT00790738|"     This study evaluates the efficacy of the thyroid hormone T3 for depression in patients with     bipolar disorder. In this study patients will be randomized to receive T3 or placebo.   "
225411|NCT00790751|"     This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to     placebo in men with mild to severe erectile dysfunction.   "
225430|NCT00790998|"     This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and     ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes     river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1     ratio) to receive one orally-administered dose of either moxidectin or ivermectin.   "
225412|NCT00790764|"     The present investigation will be a Phase II, single center, placebo-controlled, randomized,     dose escalation, infusion modality (intracoronary vs transendocardial injection using the     Cordis Biosense NOGASTAR TM Mapping Catheter with the Biosense MYOSTAR TM left ventricular     injection catheter) transplantation of an autologous (your own stem cells) combination of     bone marrow-derived stem cells into myocardium for the treatment of severe coronary ischemia.      The purpose of this research study is to determine if the infusion of a combination of stem     cells obtained from the bone marrow of the same patient will contribute to the formation of     new blood vessels in patients with symptomatic severe coronary ischemia(CI).      In this trial we will determine whether the combination stem cell treatment is safe, feasible     and results in the development of mature stable and/or collateral vessels and improvement of     cardiac function.      Coronary Ischemia (CI) is intractable angina due to severe coronary artery disease which can     seriously decrease blood flow to the heart.      CI needs a comprehensive treatment since the condition will not improve on its own. The     overall goal of the treatment is to increase blood flow to the heart and improve symptoms of     angina.      The study hypothesis is based on the concept that the process of formation of new blood     vessels is complex and requires the participation of several types of stem cells and growth     factors. The lack of any of these components will produce vessels which are immature and     unable to provide appropriate blood supply to the heart.      Patients eligible to participate in this study are those suffering from severe blockages of     the vessels of the heart and are not candidates for percutaneous revascularization or     surgical procedures.   "
225413|NCT00790777|"     The purpose of this study is to establish bioequivalence of paliperidone ER tablets     manufactured at Gurabo as compared to paliperidone ER tablets manufactured at Vacaville,     administered as a single dose of 12 mg under fasted conditions to healthy male volunteers,     and to assess the safety and tolerability of both formulations.   "
225414|NCT00790790|"     To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an     effect on pain levels.   "
225416|NCT00790816|"     This study is designed to provide continued access to lapatinib as monotherapy or as part of     a combination regimen to cancer subjects who are currently participating in a phase I trial     that has met its study objectives.   "
225418|NCT00790842|"     Patients with previously treated multiple myeloma and kidney dysfunction will be treated with     lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of     lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe     and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will     study how well the the treatment works in patients with previously treated (relapsed or     refractory) multiple myeloma and kidney dysfunction.      Biological therapies, such as lenalidomide, may stimulate the immune system in different ways     and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more     cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have     changes in their kidney function.   "
225419|NCT00790855|"     The goal of the Phase I part of this clinical research study is to find the highest safe dose     of bendamustine that can be given to patients with acute myelogenous leukemia (AML), Acute     lymphoblastic leukemia (ALL), Chronic myelogenous (or myeloid) leukemia (CML) in blastic     phase, Chronic Myelomonocytic Leukemia (CMML), and myelodysplastic syndromes (MDS).      The goal of the Phase II part of this clinical research study is to learn if bendamustine can     help to control AML, ALL and MDS. The safety of this drug will continue to be studied.   "
225420|NCT00790868|"     This is a 5-year double blind, randomized, controlled, trial conducted at three treatment     sites, aimed at showing the acute and longer-term effects of DCS augmentation of     exposure-based CBT for panic disorder relative to placebo augmentation. By demonstrating that     DCS can enhance the results of even a brief treatment strategy, we are seeking to validate an     approach that fits well wtih teh practice limitations and applications of CBT in     effectiveness studies.   "
225421|NCT00790881|"     Despite the clinical significance of potential interactions between antimalarials and     antiretrovirals, no drug interaction studies have been published and there is an urgent need     to address this gap in current knowledge.      This study aims to assess the drug interaction between the antimalarial     Artemether/Lumefantrine used for management of uncomplicated malaria and Nevirapine-based     antiretroviral therapy.   "
225422|NCT00790894|"     This is a Phase II Randomized, Open Label, Non-comparative Trial (Parallel Assignment and     Efficacy Study) for patients with HER-2 Negative Metastatic Breast Cancer Previously Treated     With chemotherapy in the Neo-Adjuvant or Adjuvant Setting.Patients will be randomized to     receive Ixabepilone either every three weeks, or weekly for three weeks followed by one week     off. Patients will be treated until consent withdrawal, intolerable toxicity or documented     disease progression   "
225423|NCT00790907|"     The purpose of this study is to compare the safety of two different dose regimens of     unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in     patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction)     who have been initially treated with fondaparinux.   "
225424|NCT00790920|"     The purpose of the study is to determine whether desmoteplase is effective and safe in the     treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of     stroke symptoms.   "
225425|NCT00790933|"     The purpose of this multicenter, open-label study is to collect data on the occurrence of     important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.   "
225426|NCT00790946|"     The purpose of this study is to consider the following points in patients with hypertension     who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard     treatment.        -  Blood pressure control        -  Changing of adiponectin and plasminogen activator inhibitor-1        -  Influence metabolizing and cardiac function, etc.   "
225427|NCT00790959|"     The SASA! Study is a cluster randomized trial of a community mobilization intervention for     the prevention of HIV and gender based violence. The study is being conducted in Kampala,     Uganda.   "
225428|NCT00790972|"     This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved     over-the-counter nasal spray, to eliminate the bacteria in your nose.   "
225431|NCT00791011|"     This is a multi-center, phase 1b study of AMG 655 in combination with bortezomib or     vorinostat in subjects with relapsed or refractory low grade lymphoma, mantle cell lymphoma,     diffuse large cell lymphoma, and Hodgkin's disease.      Part 1 is an open-label, dose-escalation phase (3+3 design) to determine the safety,     tolerability and maximum tolerated dose of AMG 655 in combination with bortezomib or     vorinostat. Subjects will be enrolled into one of two arms based on investigator selection     (either the bortezomib + AMG 655 arm or vorinostat + AMG 655 arm).      Part 2 of the study is a dose expansion phase that will commence after dose selection of AMG     655 in combination with bortezomib in Part 1. In Part 2, subjects (n = 20) with mantle cell     lymphoma will be given AMG 655 in combination with bortezomib. The dose of AMG 655 used in     combination with bortezomib will be based on safety and pharmacokinetic information obtained     from Part 1 as well as from ongoing AMG 655 trials.   "
225432|NCT00791024|"     Aim: To examine a new method to perform local anesthesia in order to diminish the     inconvenience by the procedure in patients before performing intubation or     oesophagogastroduodenoscopy.   "
225433|NCT00791037|"     This phase I/II trial is studying the side effects of escalating doses of adoptive T cell     therapy in treating patients with stage IV breast cancer. Vaccines are given to patient prior     the expansion of a person's white blood cells may help the body build an effective immune     response to kill tumor cells that overexpress human epidermal growth factor receptor 2 (HER2)   "
225473|NCT00796978|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them.      PURPOSE: This phase II trial is studying the side effects of trastuzumab and to see how well     it works in treating older women with early-stage breast cancer.   "
225434|NCT00791050|"     Although data on cardioprotective effects (as profile of troponin I)of perioperative     maintenance of normothermia during CABGs are already known, little is known about the effects     of maintaining normothermia on clinical outcomes of patients submitted to coronary surgery.     Being acute renal failure (ARF) and atrial fibrillation (AF) the two most frequent     complications of this surgery, this study compare as primary end point the rate of     postoperative ARF and AF in two group of patients, one actively warmed with Thermowrap and     the control group receiving standard institutional care.   "
225435|NCT00791063|"     The purpose of this study is to evaluate the potential of [18F]-ML-10 to serve as a     non-invasive imaging tool for the early detection of apoptosis in brain metastases in     response to radiation therapy. Such early detection may improve clinical management of     patients with brain metastases, as it may help early identification of non-responders, and     subsequently potentially lead to optimization of radiation dose, early decision on focal     irradiation of selected, non-responsive lesions, or early referral of the patient to surgery.     The experimental design of the present study aims to evaluate the potential of non-invasive     PET examination with [18F]-ML-10, to provide the clinician early in the course of treatment,     via non-invasive molecular imaging of radiation-induced apoptosis, information on tumor     responsiveness, that is currently available only several weeks to months after completion of     the radiotherapy.   "
225436|NCT00791076|"     The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is     naturally produced by the pancreas and that works to control the amount of glucose that the     liver makes, will reduce the amount of insulin required for people who must take insulin to     maintain their normal blood glucose level.   "
225437|NCT00791089|"     To determine if peri-operative treatment with omega-3 fatty acids is associated with a     decrease in the incidence of early recurrences of atrial arrhythmias (within 30 days) and an     improvement in probability of long-term maintenance of sinus rhythm after radiofrequency     catheter ablation for Atrial Fibrillation.   "
225438|NCT00791102|"     The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and     can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge     with antigen.   "
225439|NCT00791115|"     The purpose of this study is to compare the location of the cancer found in the prostate     gland after it is removed to the location that was predicted on the MRI scan during biopsy.     In this way, we can better determine if the Magnetic Resonance Imaging (MRI) was accurate,     and if the MRI could be safely used to guide other types of treatments such as brachytherapy.     We also plan to carefully measure how frequently surgery is able to completely remove the     cancer, as well as the side effects and effectiveness of surgery after radiotherapy. The     study will be coordinated and closely integrated with a separate concurrent study of     MRI-guided prostate biopsy, which will be performed prior to accrual to this trial (UHN     05-0641-C).   "
225440|NCT00791128|"     The purpose of this study is to determine whether the GI Sleeve is safe and effective in     treating Type II diabetes patients   "
225441|NCT00796562|"     The purpose of this study is to see if giving high dose chemotherapy and total body     irradiation before and repeating high dose chemotherapy after a bone marrow transplant could     reduce the incidence of graft rejection and disease for patients with blood cancers   "
225442|NCT00796575|"     The main purposes of this study are to assess the safety and measure the pharmacokinetics and     pharmacodynamics of CS-8080 in healthy volunteers.   "
225443|NCT00796588|"     The project has been designed to determine whether a brief period of leg ischemia will reduce     the I/R injury sustained by the liver during liver surgery and liver transplantation. Adult     patients (aged above 18) for liver resection (LR group) and for orthotopic liver     transplantation (OLT group) will be analysed separately. Patients from each category will be     randomised to two groups - a control and a Remote IPC group. In the remote IPC group Ischemic     preconditioning will be induced during surgery by applying a pneumatic tourniquet to the     upper part of the right thigh and then inflating it to twice the measured systolic arterial     pressure in order to occlude the blood supply of the leg for 10 minutes. The tourniquet will     then be deflated for 10 minutes to reperfuse the leg. This is repeated thrice to precondition     the skeletal muscles of the leg.   "
225444|NCT00796601|"     The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at     3 and 6 months compared to placebo.   "
225445|NCT00796614|"     Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin     hydrochloride as treatment in children with an elevated detrusor leak point pressure     associated with a known neurological deficit   "
225447|NCT00796640|"     The purpose of this study is to compare the bioavailability of 2 extended release     paliperidone pellet formulations under fasting and fed conditions with a 2 mg paliperidone     oral solution under fasting conditions. Additional objectives are to compare the     pharmacodynamic effects (postural changes in blood pressure and heart rate), to evaluate the     safety and tolerability of each treatment, and to explore the relationship between CYP2D6     genotype and paliperidone exposure.   "
225448|NCT00796653|"     The primary objective of this study is to assess the long-term efficacy and safety of once     daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat®     inhaler, in patients with COPD.   "
225449|NCT00796666|"     As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies     are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated     the controlled safety/efficacy database of the combination is limited.   "
225450|NCT00796679|"     The purpose of this study is to test the hypothesis that selective vitamin D receptor     activation reduces left ventricular hypertrophy and ameliorates inflammation and     atherosclerosis in stage 3 -5 chronic kidney disease.   "
225524|NCT00803465|"     The purpose of this study was to compare the relative vasoconstrictive effects of test and     reference topical Fluticasone Propionate 0.05% Cream in healthy, female subjects.   "
225947|NCT00810238|"     The purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of     left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells     (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy.   "
225451|NCT00796692|"     Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard,     unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and     may also be so in patients with pulmonary thromboembolism (PTE). Only limited data are     available on the evaluation of body weight adjusted LWMH and standard UFH for the initial     treatment of PTE in Chinese population. The aim of this study is to determine whether body     weight-adjusted, subcutaneous Nadroparin is as effective and safe as UFH for treatment of     patients with objectively documented PTE.   "
225452|NCT00796705|"     Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to     inflammation and progressive joint damage affecting 2.5 million people in the United States.     The primary purpose of this study is to determine the effectiveness of switching to an     alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment     with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate     clinical response to etanercept or adalimumab.   "
225453|NCT00796718|"     This single arm study will assess the efficacy and safety of treatment with Xeloda plus     standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible     participants will receive Xeloda 825mg/m^2 orally twice daily plus standard radiotherapy for     5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated     time on study treatment is < 3 months, and the target sample size is < 100 individuals.   "
225454|NCT00796731|"     The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according     to the dose limiting toxicities (DLTs) observed when administered as a single agent once     weekly.      Secondary objectives are:        -  to characterize the global safety profile        -  to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule        -  to assess preliminary evidence of anti-lymphoma activity.   "
225455|NCT00796744|"     The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it     can be tolerated, and how different doses effect the healing of the chronic foot ulcers in     diabetic subjects.   "
225456|NCT00796757|"     This single arm study will assess progression free survival, tumor response and safety of     Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with     metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every     2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week     (t.i.w.). The anticipated time on study treatment is until disease progression, and the     target sample size is 100-500 individuals.   "
225457|NCT00796770|"     The purpose of this study is to determine whether the administration of a dendritic cell     vaccine is a safe and effective treatment for HIV-1 patients.   "
225458|NCT00796783|"     This is an observational study to confirm the presence of recurrent or persistent endogenous     Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for     Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.   "
225459|NCT00796796|"     To determine the maximum tolerated dose of the drug temsirolimus given with radiation therapy     for patients with non-small cell lung cancer.   "
225460|NCT00796809|"     The goal of the project is to study the risk of coccidioidomycosis (valley fever) in patients     receiving anti-TNF and other biologic agents for inflammatory arthritis in Tucson, Arizona.   "
225461|NCT00796822|"     People infected with HIV have a greater risk of developing cardiovascular disease than people     not infected with HIV. This may be due to increased inflammation brought on by either the HIV     infection itself or the use of antiretroviral medications to treat HIV infection. This study     will evaluate an anti-inflammatory drug, pentoxifylline, to determine whether it improves     blood vessel function and reduces inflammation in people infected with HIV who are not     currently receiving antiretroviral medications.   "
225462|NCT00796835|"     The purpose of this study is to evaluate the dose proportionality of the 3-, 6-, 9-, 12-, and     15-mg tablets of ER OROS paliperidone. Additionally, the safety and tolerability of the     treatments in healthy volunteers will be assessed.   "
225463|NCT00796848|"     The purpose of doing this study is to see if continuous glucose monitoring can help people     with type 1 diabetes who are sometimes unable to feel if they have a low blood glucose     reading. For this study we will be using the Navigator Continuous Glucose Monitor. We think     that your body may not have enough of a certain hormone that usually helps people know when     they are going low. If you can keep from going low, we think there will be enough of that     hormone to help you recognize the symptoms of a low before it happens.   "
225464|NCT00796861|"     The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in     patients with refractory malignant ascites.   "
225465|NCT00796874|"     RATIONALE: Sometimes prostate cancer may not need treatment until it progresses. In this     case, active surveillance may be sufficient. Diagnostic procedures, such as magnetic     resonance imaging, may be a less invasive method of finding prostate cancer that has     progressed.      PURPOSE: This clinical trial is studying how well magnetic resonance imaging works in     detecting cancer progression in patients with early-stage prostate cancer who are undergoing     active surveillance.   "
225466|NCT00796887|"     The purpose of this study is to determine the safety, tolerability, and to explore the     possible benefit of extended-release niacin (Niaspan®) in attempting to improve the recovery     of patients after ischemic stroke.   "
225467|NCT00796900|"     Dantrolene is used to prevent hyperthermia in intensive care patients suffering from     subarachnoidal hemorrhage.   "
225468|NCT00796913|"     ATD therapy for Graves' disease is one of the commonly used options for therapy of the     hyperthyroidism. The investigators study how to optimally keep patients in remission.   "
225469|NCT00796926|"     Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry     Eyes   "
225470|NCT00796939|"     This study will determine if green light exposure during sleep is effective in reducing mild     depression symptoms in young men.   "
225471|NCT00796952|"     Swallowing dysfunction after chemo-radiation is common, but there is no reliable evidence for     how it should be managed. This pilot randomized controlled trial evaluated the relative     benefit of a battery of isometric / isotonic exercises on the maintenance of muscle     composition and function for swallowing in Head / Neck Cancer patients undergoing     chemo-radiation therapy.   "
225472|NCT00796965|"     Single Ascending Dose Study   "
225474|NCT00802815|"     Inclusion body myositis (IBM) is the most common late onset acquired muscle disease. Patients     develop progressive weakness that may result in the need for assistive devices including a     wheelchair. IBM may be due to abnormal immune activation, due in part to overproduction of     tumor necrosis factor (TNF)-alpha. Etanercept blocks the activity of TNF-alpha, thereby     blunting immune overactivation. Previous unblinded studies and case reports suggest that     etanercept may improve strength or slow the progressive weakness in IBM. We are conducting a     double-blind, randomized, placebo-controlled study to test if Etanercept is beneficial in     slowing the progressive weakness in patients with IBM.   "
225475|NCT00802828|"     Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40     mg tablet under fasting conditions.   "
225476|NCT00802841|"     There is no available data on the clinical benefit of dose escalation for patients with     suboptimal response to imatinib, and patients may still improve their response with     continuation of therapy at the standard dose as shown in the IRIS trial after 5 years of     follow-up. However, there is no data yet regarding the potential benefit of using nilotinib     in the group of patients with suboptimal response. In this study, the efficacy of nilotinib     400mg BID will be compared to imatinib 600mg QD.   "
225477|NCT00802854|"     The objective of this study is to collect the safety and efficacy data of Eraxis IV     (anidulafungin) 100 mg according to Korea Ministry of Food and Drug Safety regulations.   "
225478|NCT00802867|"     Objectives:        -  To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered          to children 4 to 6 years of age who have previously received four doses of PENTACEL™          vaccine.        -  To present immunogenicity before and after a single dose of DAPTACEL® vaccine          administered to children 4 to 6 years of age who have previously received four doses of          PENTACEL™ vaccine.   "
225479|NCT00802880|"     The purpose of this study is to determine the overall best tumor response rate to dacarbazine     given until disease progression as assessed by RECIST criteria, CT and clinical exams in     patients with metastatic sarcomas.   "
225480|NCT00802893|"     This study is designed to assess the safety and efficacy of twice-daily oral dosing of 6R-BH4     to improve endothelial function, reduce systolic blood pressure and reduce arterial     stiffness.   "
225481|NCT00802906|"     The purpose of this study is to evaluate the clinical efficacy of an initial subthreshold     retinal micropulselasercoagulation versus a single intravitreal 1.5mg bevacizumab injection     in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE     to induce reproliferation of healthy RPE cells, whereas the intravitreal injection should     non-selectively stop the RPE leakage.   "
225482|NCT00802919|"     This is a 12-week double-blind placebo controlled parallel group study of the efficacy of     varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on     cognitive function in patients with schizophrenia. Correlations will be made with biological     predictors of efficacy: a) measures of nicotinic receptors in lymphocytes b) DNMT1 and GAD67     mRNA in lymphocytes. Subjects will be current cigarette smokers or hsitory of regular     smokers.   "
225483|NCT00802932|"     The purpose of this study is to test metallic markers in the breast tissue after breast     conserving surgery and to observe the metallic markers' stability in the breast for use as     tumor bed markers and positioning devices for radiation treatment.   "
225484|NCT00802945|"     This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients     with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based     treatment in the metastatic setting.      Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered     at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d     schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may     be evaluated in this study with approximately 35 patients enrolled in each treatment arm.   "
225485|NCT00802958|"     The purpose of this study was to compare the relative vasoconstrictive effects of test and     reference Halobetasol Propionate 0.05% Ointment in healthy, female subjects.   "
225486|NCT00802971|"     Idiopathic reactive hypoglycemia (IRH) describes a condition where recurrent episodes of     symptomatic hypoglycemia occurs one to four hours after a meal, usually following meals rich     in carbohydrates. Differential diagnoses to be excluded include those caused by isulinomas or     bariatric surgery (dumping syndrome), or iatrogenic induced hypoglycaemia.      The prevalence of IRH is not fully known. A British trial among 1136 random chosen women aged     17-50, reported that 37.9% experienced symptomatic hypoglycemia four times every month (mean     value). However, not all reported symptoms attributed to a low blood glucose (BG) correlates     with measured low levels of BG and a true hypoglycaemic episode, i.e., as defined by     American Diabetes Association (ADA) when plasma BG value is < 3,9 mmol/l with or without     accompanying symptoms. This was underscored in three studies from England, Canada and     Denmark, in whom all reported hypoglycaemic symptoms, but in whom accompanying plasma glucose     values < 3,3 mmol/l during hypoglycaemic symptoms only occurred in 23, 47 and 0% of the study     subjects, respectively. The majority of those with symptoms related to IRH hence are having     these symptoms without being classified as hypoglycemic according to conventional     interpretations. However, a new (2005) ADA definition; relative hypoglycemia, also comprise     these symptomatic cases of hypoglycemia following a plasma glucose > 3,9 mmol/l.      Hormonal and cerebral mechanisms tightly control the complex interplay of mechanisms involved     in regulating BG concentration. Explanations for IRH are centralized around increased insulin     secretion/sensitivity and/or down regulated transcription of glucagon receptor or reduced     glucagons sensitivity- and secretion. Others assess an overabundance of adrenaline and     cortisol, witch is excreted at the nadir of the BS curve (venous plasma glucose between 3.6     and 3.9). The latter event, during which typical symptoms is characterized of anxiety,     fatigue, irritability, palpitations, nervousness, tachycardia, tremor and sweat.      Today, treatment is limited to dietary recommendations of eating frequent meals of moderate     size, reasonably high in protein, and with a low glycaemic load. These advices keep cerebral     glucose concentration stable and prohibit neuroglycopenic symptoms like hunger, dizziness,     tingling, blurred vision, difficulty in thinking, and faintness. Pharmacologic attempts in     treating IRH involves diazoxide, metformin, α-glucosidase inhibitor, glitazones and     somatostatin, however, none of these medications are specifically indicated for the     condition.      Fiber is a class of carbohydrate resistant to hydrolytic digestion in the upper bowel but     fermented in the colon by bacterially produced enzymes. It makes the rate of ventricular     emptying increase and prolongs the bowel transit time; thus having a minimal impact on BG     values. Inulin and oligofructose are composed of polymers of oligofructose having     characteristic features different from other fibers because of their physiological and     biochemical attributes. Found in a variety of edible fruit and vegetables, their fermentation     produces short-chain fatty acids that acidify the colonic content. This stimulates     selectively the growth of beneficial and potentially health-promoting bifidobacteria and     reduces potential harmful colon bacteria. Acting as prebiotica, oligofructose induces changes     in the colonic epithelium and in miscellaneous colonic functions, inter alia, enhances     calcium and magnesium absorption, modulates endocrine as well as immune functions and affects     the metabolism of lipids positively. The latter, being at a systemic level, may contribute to     modulating lipogenesis and reducing triglyceridemia by partially impairing hepatic     cholesterol synthesis.      FOS has not yet been investigated thoroughly as a possible stabilizer of blood glucose.     However, several non-oligofructose studies, using a high-fiber diet, indicates reduced     pre-prandial BG values, less hypoglycemic cases, glukosuri, total cholesterol, triglycerides,     VLDL cholesterol and area under the curve (AUC) in a 24 hours measurement (every 2 hour) of     BG and insulin concentration.      Clinical evaluation of safety of inulin and oligofruktose as dietary fiber has reported 20     g/day of oligofructose to be well tolerated. The various GI side effects identified include     abdominal pain and bloating, flatulence and osmotic diarrhea.      Despite the fact that fiber intake is proven inversely related to hypoglycemic events,     possible benefits of daily FOS-supplementation have not yet been investigated systematically     in persons suffering of IRH. Given the estimated high prevalence of IRH it is in our aim to:        1. Study the prevalence and characteristics of subjects with IRH in a relevant Norwegian          study population of 414 study participants.        2. Evaluating the effect of FOS supplementation on blood glucose variability.   "
225487|NCT00802984|"     The purpose of this study is to determine whether the system is safe and effective for the     intended use of treating descending thoracic aortic aneurysms.   "
225488|NCT00802997|"     to evaluate the effectiveness of cooled radiotherapy denervation of the sacroiliac region     using the sinergy system by comparing a treatment group to a placebo group   "
241839|NCT01009567|"     The purpose of this study is to investigate the efficacy and safety of cabergoline in     prevention of ovarian hyperstimulation syndrome versus albumin in ART program.   "
225489|NCT00803010|"     The purpose of this research is to compare the effectiveness of Tacrolimus and Rapamycin to     Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease.     Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell     transplants (HCT). An allogeneic hematopoietic cell transplant is a transplant using bone     marrow and blood cells that come from someone other than the patient (a donor).   "
225490|NCT00803023|"     To compare the safety and tolerability of sodium oxybate given as a combination of an oral     solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).   "
225491|NCT00803036|"     Since the primary damage from traumatic brain injury (TBI) is irreversible, the focus of     medical management of TBI is preventing secondary injury that can be life-threatening and     worsen patient outcome. Insight into the pathologic mechanisms of secondary injury, which are     largely unknown, is required for developing better treatments.      In preliminary studies, the investigators have found that a pathologic brain activity, known     as spreading depression, recurs in a large number of TBI patients in the first week after     injury. Spreading depressions are short-circuits of brain function that arise spontaneously     from an injury and spread repeatedly as waves into neighboring brain tissue. Animal research     has shown that spreading depressions can cause secondary injury to the brain.      The primary objective of this observational study is to determine whether the occurrence or     severity of spreading depression is related to worse neurologic recovery from TBI. Results     from the study will determine whether monitoring of spreading depression should be used as a     guide or target for improved medical management of the TBI patient.   "
225492|NCT00803049|"     The primary objective of this study was to document the long-term safety and tolerability of     teriflunomide in Multiple Sclerosis (MS) participants with relapse.      The secondary objective was to document the long-term efficacy on disability progression,     relapse rate and Magnetic Resonance Imaging (MRI) parameters.   "
225493|NCT00803062|"     This randomized phase III trial studies the side effects of paclitaxel when given together     with cisplatin or topotecan with or without bevacizumab and to compare how well they work in     treating patients with stage IVB, cervical cancer that has come back or is persistent. Drugs     used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere     with the ability of tumor cells to grow and spread. It is not yet known whether paclitaxel is     more effective when given together with cisplatin or topotecan with or without bevacizumab in     treating patients with cervical cancer.   "
225494|NCT00803075|"     The purpose of this study is to determine if it is safe and effective to use the TALENT AAA     Stent Graft System as a treatment for AAAs in patients who are also candidates for     conventional surgical aneurysm repair.   "
225495|NCT00803088|"     The objective of this multicenter, single-arm, open-label clinical study is to evaluate the     safety of performing bronchial thermoplasty with the Alair® System during two treatment     sessions to treat severe asthma.   "
225496|NCT00803101|"     The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N     (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin     K antagonists in subjects who require immediate correction of international normalized ratio     (INR) because of emergency surgery.   "
225497|NCT00803114|"     The investigators believe that pain management following a vaginal delivery can be improved.     Many women receive epidural medication during labor and delivery, and the investigators felt     that using the epidural following delivery might improve the first day pain. This study is to     determine whether a single dose of epidural morphine given to mothers after a vaginal     delivery will reduce the perineal pain in the postpartum period.   "
225498|NCT00803127|"     This study is designed to demonstrate the result reading clarity of the VS-SENSE is     substantially equivalent to the result reading clarity of the Nitrazine pH Paper test for     vaginal secretions.   "
225499|NCT00803140|"     Cutaneous scarring after elective surgery is a concern for surgeons of all types, perhaps     even more so to plastic surgeons. Cautery is often used on the cut setting to make or     extend incisions; however very few studies have looked at the results of these scars. The     investigators' study aims are to compare standard scalpel incisions versus cautery incisions     and to objectively compare the resultant scars in a prospective, randomized, controlled     fashion.   "
225500|NCT00803153|"     To report the safety and incidence of adverse effects, during and after a successful     photocoagulation for different pathologies using a Pattern Scan Laser (PASCAL) system and its     modified settings   "
225501|NCT00803166|"     The purpose of this study was to compare the relative vasoconstrictive effects of two test     and one reference Halobetasol Propionate 0.05% Cream in healthy, female subjects.   "
225502|NCT00803179|"     Our hypothesis is that Growth Hormone (GH) will not only target the peripheral tissue to     stimulate weight and muscle growth which will maximize nutritional potential and improve     overall quality of life. We theorize that this will occur through a multitude of factors:     increased appetite, more constructive utilization of caloric intake and decreased catabolic     signaling. The first aim will address changes in weight and lean body mass following the     institution of GH therapy in adults with Cystic Fibrosis (CF) related wasting. The second aim     will measure impact on quality of life of these individuals. Additionally, the third aim will     monitor effects of GH therapy on diabetes and insulin sensitivity. Finally, the fourth aim     will observe changes in the subjects underlying diagnosis of CF, specifically lung function,     muscle strength and inflammatory state.   "
225503|NCT00803192|"     Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40     mg tablet under fed conditions.   "
225533|NCT00803582|"     The purpose of this study is to investigate the efficacy of acupuncture for the treatment of     phonotraumatic lesions of the vocal folds, using the International Classification of     Functioning Disability and Health (World Health Organization, 2001) as the conceptual     framework to guide the selection of outcome measures.   "
225564|NCT00803985|"     The purpose of this study is to se if there is a difference regarding chronic pain and sexual     dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold     standard open fixated on lay mesh in inguinal hernia surgery.   "
225504|NCT00803205|"     Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the     cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of     mutation called a nonsense (premature stop codon) mutation is the cause of CF in     approximately 10% of subjects with the disease. Ataluren (PTC124) is an orally delivered     investigational drug that has the potential to overcome the effects of the nonsense mutation.     This study is a Phase 3 trial that will evaluate the clinical benefit of ataluren (PTC124) in     adult and pediatric patients with CF due to a nonsense mutation. The main goals of the study     are to understand whether ataluren (PTC124) can improve pulmonary function and whether the     drug can safely be given for a long period of time. The study will also assess the effects of     ataluren on CF pulmonary exacerbation frequency, cough frequency, health-related quality of     life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body     weight, and CF pathophysiology. Funding Source - FDA OOPD   "
225505|NCT00803218|"     The purpose of this study was to compare the relative vasoconstrictive effects of test and     reference topical Fluticasone Propionate 0.005% Ointments in healthy, female subjects.   "
225506|NCT00803231|"     The transparency commission wishes that the laboratory Lilly France sets up a follow-up study     describing the conditions of use of Xigris® in France.      The purpose of this study is to describe the characteristics of the treated patients, the     conditions of drug use, in particular the conditions of treatment initiation and the clinical     development of the patients during normal clinical practice, in particular rate and cause of     mortality within one month.   "
225507|NCT00803244|"     The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of     grass pollen allergen extract when initiated 2 months before the grass pollen season compared     with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.   "
225521|NCT00803426|"     Sciatic nerve block is used routinely in ankle and foot surgery. It is applied often by a     posterior approach at the popliteal fossa, near where the nerve divides into the common     peroneal and tibial nerves. Due to the size of the sciatic nerve, the largest in the body,     infiltration of anesthetic and onset of anesthesia can take a significant amount of time.     This study hypothesizes that selectively blocking both the common peroneal and the tibial     nerves distal to the bifurcation may result in a faster block onset than blockade of the     sciatic nerve proximal to its bifurcation.   "
225522|NCT00803439|"     The purpose of this study was to compare the relative vasoconstrictive effects of test and     reference Clobetasol Propionate 0.05% Topical Foam in healthy, female subjects.   "
225508|NCT00803257|"     Symptoms of CTS occur when any condition decreases the size of the carpal canal or increases     the volume of the structures within the carpal canal, compressing the median nerve. One cause     of the symptoms of CTS is the incursion of the lumbrical muscles of the hand into the carpal     canal. Individuals with CTS tend to have tight lumbrical muscles which increase this     incursion, thereby increasing CTS symptoms. An intervention designed to reduce the incursion     of the lumbrical muscles should have an effect on the symptoms of CTS.      The purpose of this study is to systematically examine the effect of an intensive lumbrical     muscle intervention, splinting to prevent lumbrical muscle incursion and lumbrical muscle     exercises, on the symptoms of CTS. This project will be a randomized clinical trial to     evaluate the effectiveness of a home program targeting the lumbrical muscles. One hundred and     twenty subjects will be assigned to one of 4 groups: Group 1 will receive a home program of     lumbrical muscle stretches combined with a lumbrical positioning splint; Group 2 will receive     a home program of lumbrical muscle stretches combined with a night wrist cock-up splint;     Group 3 will receive a home program of general stretches combined with a lumbrical     positioning splint; and Group 4 will receive a home program of general stretches combined     with a night wrist cock-up splint. After 1 month, 3 months, and 6 months the groups will be     compared to determine if there is a significant reduction in symptoms between the groups.   "
225509|NCT00803270|"     The purpose of this study is to compare treatment outcomes for patients with mixed urinary     incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is     initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and     urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery     for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up     will be a minimum of 12 Months.   "
225510|NCT00803283|"     The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral     System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR)     in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.   "
225511|NCT00803296|"     The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the     notion that this deficiency is a consequence of the diabetic state. However, the impact of     insulin resistance on the incretin effect in obese individuals who uphold a normal glucose     tolerance (NGT) despite their insulin resistant state remains to be elucidated. The primary     aim of the present study is to evaluate the separate impact of one of the cornerstones of     type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean     and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of     healthy control subjects.   "
225512|NCT00803309|"     In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having     characteristics associated with poor treatment response for additional 12 or 24 weeks beyond     the standard treatment of PEG-IFN alpha-2b plus ribavirin.      The objective of this study is to compare the efficacy of a treatment extension of 12 versus     24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 1.5 µg/kg PEG-IFN     alpha-2b and 800-1400 mg ribavirin (standard dose) for 24 weeks (standard duration) and who     are not HCV-RNA negative (< 15 IU/ml) after 4 weeks of standard treatment but HCV-RNA     negative after 16-24 weeks of standard treatment.   "
225513|NCT00803322|"     The purpose of this study is to see if involving community health workers improves     tuberculosis case finding and treatment outcome.   "
225514|NCT00803335|"     The purpose of this study is to find out how long it takes the vagina to respond to hormonal     vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address     the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.   "
246905|NCT01084161|"     To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539     in subjects undergoing open abdominal hysterectomy   "
225515|NCT00803348|"     Patients undergoing total knee arthroscopy (knee replacement) surgery usually receive a     femoral nerve block as part of their anesthetic care. Some centers administer the block with     a single shot of local anesthetic, which wears off several hours after surgery. Other centers     administer the block with a single shot followed by continuous infusion of local anesthetic,     typically for 2 to 5 days after surgery. The latter method, though good for pain control, may     result in decreased mobility (while the anesthetic is still active), longer hospital stays,     and greater risk of falls.      This study will see if using a lower concentration of local anesthetic for the continuous     femoral nerve block or only the initial single-shot dose will result in increased mobility     and shorter hospital stays.   "
225516|NCT00803361|"     This is a 15 week study comparing how well duloxetine and placebo treatments improve     generalized anxiety disorder   "
225517|NCT00803374|"     The purpose of this study is to determine if BMS-663513 administered in combination with     ipilimumab to patients with advanced malignant melanoma is safe and tolerable   "
225518|NCT00803387|"     Although Benzalkonium chloride (BAC) has been used as a preservative for many years, many     studies have demonstrated that prolonged use of topical ocular medications preserved with BAC     may exacerbate sequelae associated with ocular surface disease. These effects could lead to     the induction of subclinical inflammation,1 reduction of corneal epithelial barrier function,     2, 3 destabilization of the tear film, 4 cataract formation, 5 and an overall higher     incidence of patient complaints of dryness and irritation. 4-6 This study will compare the     efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed     formulation of latanoprost 0.005%with BAC in patients with dryness and irritation and     open-angle glaucoma or ocular hypertension. A double blind comparison will be used to assess     whether those two different formulations will affect the tear breakup times, corneal     staining, and baseline tear secretion tests in patients that are already taking latanoprost     regularly with complaints of dryness and irritation. Patients included in the study will be     given two bottles, one labeled for their right eye and the other for their left eye. Each     pair of bottles will be identical in appearance and randomized with either latanoprost or     travoprost and each pair will be assigned a number to aid in future analysis of the final     results.   "
225519|NCT00803400|"     The purpose of this study is to determine whether the combination of aerobic physical     exercise and alprazolam in patients with panic disorder has a better therapeutic response     than the treatment with alprazolam alone.   "
225520|NCT00803413|"     Do Back School and/or supervised walking improve reported pain and spine flexibility in     sedentary women with chronic low back pain (LBP)?   "
225525|NCT00803478|"     Corneal sensation is known to play a role in tear secretion. Decreased sensation leads to     decreased tear production; and when bilateral, leads to a decreased blink rate as well. Dry     eyes are a common side effect of LASIK. Incidence rates vary widely, but have been reported     in as many as 59% of patients. And almost all patients have some transient dry eye symptoms     immediately following LASIK.      Previous studies have looked at the effect of hinge position (superior vs. nasal) and hinge     width on corneal sensation and dry eye after LASIK performed with a mechanical microkeratome.     Corneal sensation was decreased and dry eye signs and symptoms increased immediately     following LASIK in all eyes. These parameters then improved at all time periods between 1     week and 6 months post-operative. Loss of corneal sensation and dry eye signs and symptoms     were greater in eyes with superior-hinge flap than nasal-hinge flap, and in eyes with     narrower hinge flap rather than wider hinge flap IntraLase LASIK, using the IntraLase     femtosecond laser rather than a mechanical microkeratome to cut the corneal flap, has become     an increasingly popular procedure. It provides several advantages over mechanical     microkeratomes, including reduced surgical complications, more predictable flap thickness,     better astigmatic neutrality, decreased epithelial injury, and an ability to operate on a     wider range of patients.      The investigators propose this study to evaluate the effect of flap hinge size and flap     thickness in corneal flaps created with the IntraLase laser. The investigators would like to     determine if there is a difference from the previously discussed results found when using the     mechanical microkeratome. Also, with the increased ease of programming alternate hinge width     or flap thickness with IntraLase, if the investigators find a significant difference with an     alternate flap configuration, it might translate to a feasible change in clinical practice.   "
225526|NCT00803491|"     Randomized controlled trial including 200 subjects with rheumatic diseases. Subjects will be     randomized to either a self-promoting problem based learning (PBL) program or a control group     with traditional care. The hypothesis is that a PBL program will improve health-related     quality of life, empowerment and self-care ability.   "
225527|NCT00803504|"     Glaucoma is one of the most common causes of blindness in the industrialized nations. For a     long time glaucoma has been defined as a disease in which high intraocular pressure (IOP)     leads to irreversible optic disc damage and subsequent visual field loss. However, recent     investigations show that IOP is not the only factor that is involved in the glaucomatous     process leading to retinal ganglion cell death. The role of vascular factors in the     pathogenesis of glaucoma has recently received much attention based on animal experiments and     epidemiological studies. It is, however, assumed that vascular factors do not contribute to     same degree in all glaucoma patients. Generally, it is believed that a vascular component is     more important in normal tension glaucoma patients and patients with underlying     cardiovascular disease. Little is, however, known about a potential association between optic     nerve head morphology and ocular perfusion in POAG patients. The current study seeks to gain     insight into this association by assessing ocular blood flow parameters with a number of     noninvasive technologies.   "
225528|NCT00803517|"     This study is a comparison of multifocal electroretinogram assessment between the laser     treatment group and the photodynamic therapy group in chronic central serous     chorioretinopathy.   "
225529|NCT00803530|"     This is a prospective, multicenter phase II trial designed to evaluate the safety and     activity of the combination of association of arsenic trioxide (ATO) and ascorbic acid in     patients with myelodysplastic syndromes   "
225530|NCT00803543|"     The purpose of the study is to determine how common herpes is among persons with HIV who do     not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in     the blood, and the amount of HSV in bodily secretions.   "
225531|NCT00803556|"     To determine the Maximally Tolerable Dose (MTD) of KOS-1022 when administered weekly in     combination with trastuzumab or in combination with trastuzumab and paclitaxel to patients     with advanced solid tumor malignancies   "
225532|NCT00803569|"     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective     immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating     patients with stage II, stage III, or stage IV ovarian epithelial cancer, fallopian tube     cancer, or primary peritoneal cavity cancer.   "
225534|NCT00803595|"     The primary objective of this study is to confirm the efficacy of CS-8958 administered as a     single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir     phosphate using the time to alleviation of influenza illness. For safety evaluation,     between-group comparisons will be made with regard to incidence of adverse events and other     safety measures.      In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated     based on the efficacy and safety of single inhaled low or high dose.   "
225535|NCT00803608|"     To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in     recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of     consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least     one recently healed plantar MTH foot ulcer (>1 week but <12 weeks since heeling) and have     Loss of Protective Sensation.   "
225536|NCT00803621|"     With a HIV incidence much higher in the DFA than in European French territory, this disease     is a major public health problem in these areas, especially in French Guiana.      Cerebral toxoplasmosis is a priority among the opportunistic infections in AIDS patients from     the DFA because of its frequency (French West Indies) and of its lethality (French Guiana).      The diagnosis of cerebral toxoplasmosis may be difficult because based only on presumptive     clinical and radiological features. The response to specific antitoxoplasmic therapy confirms     a posteriori the diagnosis.      In reference to the data collected by the Biological Resource Centre Toxoplasma, in     particular in French Guiana, we think that T. gondii strains reactivating in AIDS patients     from DFA are genetically different from those reactivating in AIDS patients from Europe, with     an increased capacity for dissemination via peripheral blood in the first ones. This more     frequent or more prolonged parasitemia could facilitate the diagnosis of cerebral     toxoplasmosis by PCR test from peripheral blood samples in AIDS patients from the French     departments of America.   "
225537|NCT00803634|"     The purpose of this study was to evaluate the efficacy and safety of intravenous (IV)     clevidipine as compared with standard of care IV antihypertensive agents for blood pressure     (BP) lowering in patients with acute heart failure and elevated BP.   "
225573|NCT00804102|"     Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced     secretion of neurotrophic substances and direct stimulation of neurons.   "
226142|NCT00813982|"     The purpose of this study is to compare an experimental contact lens with a currently     marketed contact lens.   "
225538|NCT00803647|"     FC-6 is a Phase II, multi-center clinical trial for patients with unresectable, wild-type     K-RAS, colorectal cancer with metastases confined to the liver. Liver metastases must be     determined by FC-6 criteria to be unresectable, and the colorectal cancer (CRC) tumor     (primary or metastatic) must be found to be wild-type K-RAS. Patients with mutant K-RAS     tumors are ineligible. K-RAS testing can be done through the local hospital or a tumor sample     can be submitted to the FC-6 central lab (Esoterix Clinical Trial Services).      A primary aim of this study is to evaluate the surgical conversion rate using cytotoxic     combination chemotherapy and biologic therapy with cetuximab, a monoclonal antibody targeted     against the epidermal growth factor receptor. A second primary aim is to evaluate the safety     and tolerability of a chemotherapy/targeted therapy regimen in this patient population.     Secondary aims include determination of clinical response rate, recurrence-free survival for     patients undergoing complete resection and/or ablation of liver metastases, and overall     survival.   "
225539|NCT00803660|"     Multi-centre survey of type 2 diabetic patients who are currently on anti-hypertensive     treatment. Data collection for each patient will take place at one visit. To observe the     proportion of diabetic patients on antihypertensive treatment reaching the BP<130/80 mmHg. To     observe the proportion of diabetic patients on antihypertensive treatment reaching the     BP<130/80 mmHg by treatment groups. To observe the proportion of patients achieving a     therapeutic glycemic response defined as HbA1c=<7%. To observe the proportion of patients     achieving fasting plasma glucose<110 mg%. To identify factors for not achieving BP<130/80     mmHg. To describe percentage of patients with positive proteinuria (including     microalbuminuria) by treatment groups .   "
225540|NCT00803673|"     This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in     healthy volunteers   "
225541|NCT00803686|"     This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at     night and to compare these results with those obtained with a placebo control and with     commercially available nasal calcitonin.   "
225542|NCT00803699|"     In this study, we will evaluate the effectiveness of several doses of oral selenomethionine     in raising biomarkers of selenium status including plasma selenium concentrations.   "
225543|NCT00803712|"     Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination     with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism     (SHPT) Recently Initiating Hemodialysis   "
225544|NCT00803725|"     The purpose of this study is to determine if the addition of intrathecal fentanyl to low dose     mepivacaine spinal anesthesia provides adequate surgical anesthesia with shorter duration of     motor blockade.      It is hypothesized that lower doses of spinal mepivacaine when combined with fentanyl will     result in adequate surgical block for knee arthroscopy surgery with faster recovery and     discharge compared to mepivacaine alone.   "
225545|NCT00803738|"     The objectives of this study were to demonstrate comparable safety and efficacy of     Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories,     80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order     to establish bioequivalence.   "
225546|NCT00803751|"     This study is intended to examine the effectiveness of a new type of laryngoscope, the     Truview EVO2, in an infant patient population. They device will be tested against the current     clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital     in terms of ease of use, view obtained of the vocal cords, and ability to place an     endotracheal tube.   "
225547|NCT00803764|"     Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets,     administered as a 1 x 500 mg tablet under fed conditions.   "
225548|NCT00803777|"     The purpose of this study is to evaluate the performance and acceptability of a new blood     glucose meter.   "
246978|NCT01076998|"     The purpose of this study is to compare the comfort and blurriness of the investigational     lubricant eye drop with a marketed artificial tear ointment.   "
225549|NCT00803790|"     This study will evaluate the bioequivalence of alendronate in combination with vitamin D     compared to alendronate alone and the bioequivalence of vitamin D in combination with     alendronate compared to vitamin D alone.      This was an open-label, randomized, 2-part, crossover study. Each participant participated in     one part of the study only (i.e., each participant participated only in Part I or only in     Part II). Participants entered the study sequentially within each part of the study. A     washout of at least 12 days separated each treatment period within each part of the study.   "
225550|NCT00803803|"     The purpose of this investigation, in which pilocarpine was given in repeated doses, was to     evaluate: Part I - the effects of different concentrations of pilocarpine hydrochloride on     intraocular pressure. Part II -the effects on intraocular pressure of glaucomatous patients     to pilocarpine 2% when given once, twice and four daily. In addition, we studied various     attributes of the eye which may serve as indicators of responsiveness of individual patients     to pilocarpine.   "
225551|NCT00803816|"     Study efficacy of everolimus on course of uveitis:        -  obtain quiescence of inflammation after start of treatment        -  duration to obtain quiescence of inflammation        -  number of patients with quiescence of inflammation   "
225552|NCT00803829|"     Ulcerative colitis (UC) is one of the two main forms of inflammatory bowel disease. UC is     associated with high morbidity and incurs significant social, commercial and NHS costs. For a     variety of reasons, many patients are refractile to standard therapies, which often have     undesirable side-effects. However, an inexpensive and non-toxic treatment based on the     synbiotic concept may prove to be effective in these individuals. A synbiotic is a mixture of     a probiotic (a live microorganism) and a prebiotic, which is a carbohydrate that serves as a     food source for the probiotic, allowing it to grow better in the gut. The aim of this study     is to determine whether a synbiotic comprised of fructooligosaccharides and inulin, together     with a bifidobacterial probiotic (Bifidobacterium longum), that we have previously shown to     reduce inflammatory processes in the gut wall (mucosa) in a short-term pilot trial, can     colonise the bowel, reduce mucosal inflammation, and induce remission in UC patients with     active disease. It is planned to establish a double-blinded, controlled, randomised     investigation involving 46 patients for six months. If the results from our pilot study can     be reproduced and maintained in a long-term investigation, the synbiotic could become     available very quickly, and would provide an inexpensive and effective treatment for UC,     making a significant contribution to relieving the clinical and financial burdens of this     disease.   "
225600|NCT00804453|"     The primary objective is to collect data to evaluate the biocompatibility of two types of     blood circuit, already on the market.   "
225553|NCT00803842|"     A side effect occurring in a majority of patients taking erlotinib (Tarceva®) consists of a     skin rash. Sometimes, symptoms associated with the rash necessitate erlotinib dose reduction     or discontinuation. Some physicians have successfully treated the erlotinib-induced rash with     doxycycline. At the same time, it has been observed that in patients who develop the     erlotinib rash, the cancers respond better to erlotinib treatment. This research study is     designed to determine how well doxycycline treats the erlotinib rash and whether doxycycline     affects the blood levels of erlotinib.   "
225554|NCT00803855|"     The primary purpose of this study is to assess the safety and tolerability of AZD1446     following single dose administration.   "
225555|NCT00803868|"     The purpose of this study is to determine if varenicline is effective in treating symptoms of     Friedreich's ataxia.   "
225556|NCT00803881|"     Aim of the study is to detect the prevalence of chronic rhinosinusitis, pathogen colonization     of the lower and upper airways and, in a sub-cohort the sense of smelling in patients with     cystic fibrosis.   "
225557|NCT00803894|"     The purpose of this study is to determine the transcriptional signature of Notch Inhibition     by testing hair and blood samples on healthy male volunteers who have received MK0752 vs     placebo for possible future biomarkers in the treatment of cancer or Alzheimers Disease   "
225558|NCT00803907|"     This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the     periorbital region.   "
225559|NCT00803920|"     The purpose of this substudy is to obtain CGM data from individuals taking exenatide. The CGM     measurements gathered before starting and during treatment with exenatide IR and/or exenatide     LAR will help determine the characteristics of glucose control during treatment.   "
225560|NCT00803933|"     Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the     last decade, and in many places the demand largely surpasses the capacities of the treatment     centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be     administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There     are currently no drugs that are easily administered and have low toxicity, and might thus be     used as tools to support disease control.      This study aims to compare the safety and efficacy of DB289, a new, orally administered     dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping     sickness. The project will be executed in the framework of an international consortium     consisting of several partners from academia, industry and from the Democratic Republic of     Congo Ministries of Health.   "
225561|NCT00803946|"     Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg     Tablets, administered as a 1 x 800 mg tablet, under fed conditions.   "
225562|NCT00803959|"     Although no reliable and specific figures are available for the total expenditure on UDS, UDS     is commonly performed for patients with urinary incontinence (UI) regardless of gender and     age. UDS is typically performed prior to incontinence surgery. Urodynamic studies are     expensive, time-consuming, and uncomfortable diagnostic investigations. The 3rd ICI reported     insufficient evidence with which to answer the following key research questions related to     UDS: 1) Do physicians alter clinical decision-making based on results of UDS?, and 2) Do     alterations in clinical decisions made in response to UDS results improve the clinical     outcomes?   "
225563|NCT00803972|"     This is a single center, Phase I, open-label, single-blind (subjects blinded to the contents     of each injection), 4 stage study designed to determine the PK, GD, safety, tolerability, and     optimal ratio of rHuPH20 administered with fixed Humulin R or Humalog doses in healthy     subjects.   "
242394|NCT01027039|"     The purpose of this study is to examine if there is a difference between glaucoma patients     having background music and not having background music before visual field testing.   "
225565|NCT00803998|"     The Ocular Hypertension Treatment Study is a multi-center clinical trial sponsored by the     National Eye Institute, designed to determine the efficacy and safety of topically     administered eye lowering medication   "
225566|NCT00804011|"     In the mechanically ventilated patient, the single greatest cause of imposed work of     breathing is the resistance caused by the endotracheal tube. Commonly used maneuvers to     overcome this resistance include the use of continuous positive airway pressure or pressure     support.However, a new mode of ventilatory support called automatic tube compensation (ATC)     delivers exactly the amount of pressure necessary to overcome the resistive load imposed by     the endotracheal tube for the flow measured at the time (so called variable pressure     support).      The aim of this study is to evaluate whether a combination of pressure support with automatic     tube compensation is superior to PS alone in weaning patients with severe neurotoxic snake     envenoming.   "
225567|NCT00804024|"     The primary goal of this registry is to collect data regarding the use of the ClearWay RX     Local Therapeutic Infusion Catheter for all indications.   "
225568|NCT00804037|"     SUMMARY INTRODUCTION: among various treatments for patients with primary snoring, upper     airway resistance syndrome (UARS) and obstructive sleep apnea syndrome (OSAS), the injection     snoreplasty arose as a promising alternative in some selected cases.      OBJECTIVE: to investigate the efficacy and tolerance of injection snoreplasty comparing     Ethanol and Ethanolamine Oleate.   "
225569|NCT00804050|"     This is a prospective, randomized multicenter phase III clinical trial designed to evaluate     the safety and activity of comparison between Erythropoietin and Erythropoietin Associated to     Differentiating Therapy With Acid 13-Cis-Retinoic and Dihydroxyvitamin D3 in Myelodysplastic     Syndromes Without Excess of Blasts   "
225570|NCT00804063|"     Glaucoma might be a mitochondria associated disease. Since citrate is a major component in     mitochondrial metabolism its determination in blood might serve as a biomarker.   "
225571|NCT00804076|"     The primary purpose of this study is to examine the safety of NP2 (a nonreplicating HSV-based     vector expressing enkephalin) in patients with cancer pain. The secondary purpose is to     evaluate efficacy.   "
225572|NCT00804089|"     The purpose of this study is to compare the therapeutic effects of acupuncture using     traditional acupoints and Ashi points with myofascial trigger points superficial dry needling     and acupressure, followed by postisometric stretching of the appropriate muscles, in the     treatment of patients with chronic mechanical low back pain.   "
225629|NCT00804843|"     This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers   "
225574|NCT00804115|"     Purpose: To determine the efficacy of treatment with latanoprost in combination with     pilocarpine versus timolol or timolol/dorzolamide fixed combination (Timoptic or Cosopt) in     eyes with XFS and elevated intraocular pressure (IOP).      Methods: This is a randomized, open-label study to test the hypothesis that improving both     pressure-dependent and pressure-independent aqueous outflow and minimizing iridolenticular     friction will interfere with the progression of XFS, allow improvement in trabecular     function, and be more effective over time than simply reducing aqueous formation.     Randomization was performed across the centers, per patient rather than per eye to avoid any     crossover effect caused by aqueous suppressants. Group I was treated with latanoprost and     pilocarpine, both in the evening, and Group II with Timolol or Cosopt b.i.d. Only one eye per     patient was randomized. Patients were followed for 2 years with assessment of IOP, visual     field progression, tonographic outflow coefficient and trabecular pigmentation at the 6:00     and 12:00 position.   "
225575|NCT00804128|"     RATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose     ductal carcinoma in situ.      PURPOSE: This randomized clinical trial is studying contrast-enhanced MRI in women with     ductal breast carcinoma in situ and in healthy volunteers.   "
225576|NCT00804141|"     This is a one-year study to evaluate the long-term safety and tolerability of the     subcutaneous (just under the skin) injection form of MOA-728 for the treatment of     opioid-induced constipation in subjects with nonmalignant pain. The study consists of a 2     week screening period, a 48 week open-label treatment period and a 2 week follow-up period.     Subjects will need to agree to self-administer subcutaneous injections, complete daily     diaries, and check-in via a daily telephone call during that year-long period.   "
225577|NCT00804154|"     This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to     treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a     cactus-like plant. It is similar to capsaicin, the active ingredient in hot pepper. RTX has     relieved pain and reduced the need for pain medication in several animal experiments. It     works by destroying nerves that transmit pain information.      People at least 18 years of age with severe pain from advanced cancer at or below the level     of the chest that cannot be controlled with standard treatments may be eligible for this     study. Participants undergo the following procedures:      Pretreatment Visit      Before beginning treatment with RTX, patients give a medical history and undergo a physical     examination that includes:        -  Electrocardiogram (EKG)        -  Blood draw        -  Urinalysis        -  Neurological examinations        -  Peak expiratory flow rate (PEFR)        -  Eye examination        -  MRI        -  Urology assessment        -  Pregnancy test, when appropriate        -  Questionnaires to collect information on health, personality, mood, pain levels and          symptoms.           2-Day Hospitalization      Patients are hospitalized for 2 days for RTX injection and monitoring, as follows:        -  RTX injection: RTX is injected in the operating room under general anesthesia. It is          given through a catheter placed in the patient s spine. The catheter is also used to          obtain samples of cerebrospinal fluid (CSF) the clear fluid that bathes the spinal cord.          The fluid is examined to assess drug effects and side effects, chemical changes in the          content of the CSF associated with RTX, and how RTX is handled by the body.        -  Post-injection monitoring, including:        -  Surveys about symptoms such as pain or weakness        -  Neurological examinations        -  Blood and CSF sampling        -  EKG        -  AEs      Outpatient followup        -  Vitals        -  Blood draw, Urinalysis, neurological and sensory testing, EKG on days 7, 14 and 30 after          the injection        -  MRI scans of the head and back, Urology assessment and PEFR on day 15 after the          injection        -  Eye examination        -  Follow-up phone calls monthly for 6 months   "
225578|NCT00804167|"     Describe the clinical characteristics of hypertensive patients aged of 75 years and older     seen in general practitioner consultation according to their renal damage   "
225590|NCT00804323|"     Argon laser trabeculoplasty (ALT) with 100 ms pulses is an effective therapy for lowering     intraocular pressure (IOP). Similar reductions in IOP have been achieved using ns (SLT) and     microsecond (MLT) pulses, which produce less thermal damage to trabecular meshwork (TM). Lack     of clinically visible changes may make the accurate alignment of subsequent pulses difficult.     We describe a novel technique - Patterned Laser Trabeculoplasty (PLT) using the PASCAL     Photocoagulator system, and its preliminary evaluation in patients with open angle glaucoma.   "
243768|NCT01050465|"     The specific aim of this proposed pilot study is to compare two standardized processes (paper     and electronic) to deliver a customized MedlinePlus health information prescription.   "
225579|NCT00804180|"     The specific aim of this project is to determine the impact of this group therapy     intervention on improving adherence, coping, and functioning among children and adolescents     with disease processes requiring injections who experience injection-related     anxiety.Hypotheses include:        1. General psychosocial (quality of life) improvements from beginning to post-treatment as          well as maintenance of these improvements 2-4 weeks following the termination of          treatment for both youth and parents.        2. Reduced injection-related anxiety from baseline to post-treatment as well as maintenance          of this improvement 2-4 weeks following the end of treatment for both youth and parents.        3. Reduced anxiety immediately following exposure to feared injection- related stimuli.        4. For participants experiencing poor adherence to medical treatment, improvement in          adherence as reported by both parents and youth from baseline to post-treatment as well          as maintenance of these improvements 2-4 weeks following the end of treatment.   "
225580|NCT00804193|"     The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox     Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference     Product) in the treatment of subjects with tinea pedis, and to show the superiority of the     active treatments over that of the vehicle.   "
225581|NCT00804206|"     Compare the effect of an intravitreal injection of bevacizumab previous or posterior of     panretinal laser photocoagulation (PRLP) with a pattern laser; to prevent and reduce diabetic     macular edema (DME) in patients with proliferative diabetic retinopathy (PDR) with DME.   "
225582|NCT00804219|"     The phenomenon of no- and low-responsiveness has been described after applications of     different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees.      The aim of this project is to investigate the humoral and cellular immune responses of     low-responders after TBE vaccination in order to find parameters regarding immunoregulation     against TBE. It is of interest if non-responsiveness is a general immunological deficit of a     distinct patient group or if it is a antigen-specific phenomenon.   "
225583|NCT00804232|"     Purpose of the study:      To compare three different regimes for children newly diagnosed with type 1 diabetes: (1)     traditional hospital based care, (2) intensive psychological support to the family, and (3)     home based family psychosocial support. A further aim is to identify families were the child     runs the risk of decreased metabolic control and to give those families increased support.      Specific objectives:      The main objectives of the study are:        1. to analyse the effects on child health of family-based home care compared to traditional          hospital-based care, and        2. to analyse the effects on child health of family-based psychological treatment compared          to traditional hospital-based treatment.      The main focus will be on child health and changes in child health. Several variables will be     collected for these purpose (see instruments, below), the main variable being the child's     metabolic control. We will also analyse effects on the amount and content of (1) parental     efforts (absenteeism from work; time use which is conditional on the child's diabetes etc),     and (2) formal health care utilisation of the home-based care and psychological treatment,     respectively, compared to traditional care.   "
225647|NCT00805077|"     The purpose of this trial is to evaluate the efficacy and the safety of lung protective     ventilation during anesthesia in patients undergoing pneumonectomy or lobectomy for lung     cancer.   "
225584|NCT00804245|"     RATIONALE: New diagnostic procedures, such as C-11 choline PET-CT scan, may be effective in     finding cancer that has spread to the bone and lymph nodes in patients with prostate cancer.      PURPOSE: This clinical trial is studying how well C-11 choline PET-CT scan works in finding     metastases in patients with newly diagnosed high-risk prostate cancer.   "
225585|NCT00804258|"     RATIONALE: Palliative care may help improve the quality of life of patients with ovarian     cancer who are undergoing intraperitoneal chemotherapy.      PURPOSE: This clinical trial is studying palliative care in patients with ovarian cancer who     are undergoing intraperitoneal chemotherapy.   "
225586|NCT00804271|"     To validate a new Alzheimer's Disease scale against other rating tools in subjects with     dementia of Alzheimer's type, treated with memantine.   "
225587|NCT00804284|"     The objective for this study is to characterize the safety profile of PENTACEL® vaccine for     identification of potential vaccine-related adverse events not currently associated with     PENTACEL® vaccine administration.   "
225588|NCT00804297|"     Background:      Hypoglycemia is a common presentation to the Emergency Department. Management has     traditionally involved rapid administration of IV 50% dextrose and dextrose containing IV     fluids in addition to oral carbohydrates. Hypoglycemic patients taking only insulin can often     times be treated as outlined above and safely discharged to home after a period of short     observation in the Emergency Department. This procedure is also followed in the pre-hospital     care arena, where insulin-dependent hypoglycemic patients are often treated and released.      In addition to diet-control and insulin, patients with diabetes maintain outpatient     euglycemia with a class of drugs called sulfonylurea agents. This are believed to stimulate     insulin release from pancreatic beta cells via a complex mechanism culminating in calcium     influx and release of stored insulin from secretory granules within the pancreas. Whereas     insulin-dependent diabetic patients are usually discharged home after establishing normal     blood glucose levels, hospital admission is generally recommended in hypoglycemic patients     taking oral sulfonylureas due to the long duration of effect and delayed clearance of the     drugs and their metabolites and subsequent high likelihood of recurrent hypoglycemic     episodes.      Octreotide is a somatostatin analog that is known to suppress numerous hormones including     insulin. Dextrose itself induces insulin secretion thus theoretically contributing to rebound     hypoglycemia when used to treat hypoglycemia. Octreotide is thought to block the elevated     insulin levels that are a result of both the sulfonlyureas and dextrose. Recent case reports     and one prospective study in healthy volunteers have demonstrated the safety and efficacy of     octreotide administration for the treatment of sulfonylurea induced hypoglycemia. Based     largely on the results of these studies some experts in field of toxicology have argued that     administration of octreotide be standard therapy for all patients with recurrent hypoglycemic     episodes who are known to be taking sulfonylureas.      Purpose:      Measure the difference in serum glucose and the incidence of hypoglycemia between two groups     of sulfonylurea-dependent patients; a control group that receives standard therapy and an     experimental group that receives standard therapy plus octreotide.   "
225589|NCT00804310|"     RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as ixabepilone, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving lapatinib together with ixabepilone may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib given     together with ixabepilone in treating patients with advanced solid tumors.   "
225605|NCT00804518|"     The purpose of this study is to determine the effect of aerobic interval training on left-     and right ventricular diastolic- and systolic function on healthy, sedate people over 70     years. The old sedate cohort will be compared to young, sedate subjects also performing     aerobic interval training and old master athletes without intervention.   "
225591|NCT00804336|"     The purpose of this research study is to determine the safety of the combination of SOM230     and RAD001, as well as determine the highest dose of this combination that can be given to     people safely. SOM230 is an investigational drug that is similar to Sandostatin LAR.     Sandostatin is an approved drug for the use of treating symptoms of neuroendocrine tumors.     SOM230 has shown to be effective in patients who have become resistant to Sandostatin and may     also stop cancer cells from growing. RAD001 is an investigational drug that also may stop     cancer cells from growing.   "
225592|NCT00804349|"     Heart Failure affects 5-6 million Americans and there are about 550 thousand new cases of     heart failure every year. There are approximately 3 million hospital admission for acute     decompensated heart failure with hospital readmission rate of 20% at 30 days and 50% at 60     day, costing up to 20 billion dollars per year. In our previous study we have discovered that     sleep disordered breathing is prevalent in 70% of patients with acute decompensated heart     failure. We hypothesize that, detection and treatment of sleep disordered breathing in acute     decompensated heart failure patients will reduce episodic hypoxic events during acute     decompensation and may decrease hospital length of stay and reduce future readmissions.   "
225593|NCT00804362|"     The purpose of this study is to validate a brief survey tool, the SCD Pain Burden Interview     (SCPBI), which can be used in the clinical and/or research settings to assess the impact of     pain on children with sickle cell disease.   "
225594|NCT00804375|"     Primary: To compare the analgesic effect over 12 weeks of topical 2PX in stump pain.      Secondary: To prospectively measure other efficacy and safety variables of topical 2PX in     stump pain. Exploratory analyses will be performed to measure efficacy and safety variables     of topical 2PX in phantom pain   "
225595|NCT00804388|"     The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis     with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head     compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA.      The polyethylene to be used is E-Poly (Biomet).      The H0 hypothesis is that there is no difference with regard to polyethylene wear and bone     loss between the two groups.   "
225596|NCT00804401|"     Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets,     administered as a 1 x 500 mg tablet under fasting conditions.   "
225597|NCT00804414|"     Evaluation of efficacy and safety of SBG vs placebo in the treatment of chronic diabetic foot     ulcers.   "
225598|NCT00804427|"     The purpose of this small, short pilot study is to determine the feasibility (e.g.,     recruitment, dose acceptance, retention) of a future longer trial comparing the effects of     two types of omega-3 fats from fish oil on plasma triglycerides. The two types of fish oil     are composed of (1) omega-3 fatty acids in triglyceride form; and (2) as esterified free     fatty acids (i.e. ethyl esters). Although these two types of fish oil supplements are     available to the public, it remains unclear whether they are equally effective in lowering     plasma triglycerides.   "
225599|NCT00804440|"     Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg     Tablets, administered as a single, one-tablet dose in fasted subjects.   "
225601|NCT00804466|"     Background:        -  Cervical cancer is caused by persistent infection of the lining of the cervix with some          kinds of human papillomaviruses (HPV). These HPV infections are distantly related to the          viruses that cause warts on the skin. Like common wart viruses, most women who have          cervical infections with HPV resolve the infections within 2 years without any need for          treatment. Cervical infections that do not go away may cause disease that can turn into          cancer after many years.        -  Only one study has been done in Nigeria to learn how many women have HPV infection. The          results of the study differed from most other studies in the world because older women          were much more likely to be infected. This study with learn whether the results found in          the previous study are true in Irun also, the site of the current study.      Objectives:        -  To examine the age distribution of HPV infection and relationship to cancer of the          cervix among Nigerian women.        -  To understand how different screening methods, including HPV testing, could best reduce          the risk of cervical cancer in Nigerian women.      Eligibility:      - Women residing in Irun, Nigeria, who are 15 years of age or older.      Design:        -  Participants complete a brief questionnaire related to demographics, household and          living conditions and a longer survey with questions related to reproductive history,          family history, illnesses, stressful life events and sexual history (U. of Michigan          collaboration).        -  Participants have a cervical examination, HPV test, Pap test and blood test.        -  Women whose tests show they are infected with HPV or have cervical disease will do the          following:        -  see a doctor and have cervical biopsies of all white abnormal areas (removal of a small          tissue sample from the cervix)        -  have photographs of the cervix taken        -  have a cervical scraping for a new kind of HPV test.        -  Some women with normal test results are also asked to see a doctor to check the validity          of the testing        -  Women with cervical disease receive treatment by a specialist and remain in the program          until treatment is successfully completed or a final diagnosis is reached.        -  Participants may be contacted for followup up to 5 years after the final diagnosis is          made.   "
225602|NCT00804479|"     To determine the long-term consequences (8 years) of initiating patients with Parkinson's     disease on either pramipexole or levodopa. We hypothesize that patients initiating therapy     with pramipexole compared with levodopa will demonstrate less self-reported disability as     measured by the Modified Schwab and England (S/E) scale 8 years after randomization.   "
225603|NCT00804492|"     Falls, with a high prevalence, high risk and consequent medical and social costs, are an     important issue for medical care and health promotion in the elderly. The prevalence of falls     in the elderly lies in between 10-20%. Falls have become the second leading cause of death     from injury for the elderly in Taiwan. A community-based study showed that, among those old     adults after a fall, 27.3% were severely injured, 53.9% got a minor injury, and only 18.9%     remained intact. Another study revealed that among fall injury events reported, 42% were     hospitalized, of whom 2.2% died in hospital, and 37% entered nursing homes after discharge     from hospital. In addition to physical discomfort, half of the elderly fallers would become     disabled, and bring a heavy burden of social economy and family care. It was estimated that     there were 460 thousand of old people who had a fall, and 125 thousand of them were injured     in Taiwan, 2007. Research evidence shows that falls prevention is effective and feasible.     Although primary falls prevention programs have been conducted at the community level and     extended to 25 counties and cities for many years, they were not integrated with secondary     and tertiary prevention. The study aims to establish an integrated fall prevention model,     combined with primary, secondary and tertiary prevention. The model will be practiced in     participating hospitals and communities, with a randomized control trial (RCT) design to     examine its feasibility and effectiveness. Our study subjects are persons aged 65 and over     who live in communities, go to out-patient departments (OPD) or emergency room (ER) care.      Tasks for implementation        1. To organize a multidisciplinary team for integrated falls prevention.        2. To draft a guideline for falls prevention in the elderly.        3. To set up a multidisciplinary fall clinic.        4. To set up a falls prevention classroom.        5. To enhance cooperate between hospitals and primary care units to fulfill the guideline          for falls prevention in the elderly.   "
225604|NCT00804505|"     The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens     clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when     studied:        -  within the corresponding range of lens powers        -  in a population randomized within multiple investigational sites        -  with a study ration of 2/1 test vs control lenses        -  for a duration of 90 days.   "
225642|NCT00805012|"     To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and     neck squamous cell carcinoma   "
225606|NCT00804531|"     To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the     inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on     magnetic resonance imaging.      Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients     with inflammatory discopathy   "
225607|NCT00804544|"     99mTc-SestaMIBI mammoscintigraphy (MMS) may be used in patients with locally advanced breast     cancer (LABC) scheduled for neoadjuvant chemotherapy. MMS may be performed for 1) nodal     staging of axillary lymph node metastases, 2) prediction of chemosensitivity or Pgp/MDR-1     mediated chemoresistance, and 3) evaluation of efficacy to chemotherapy and radiation     therapy.      MMS is routinely performed with planar/SPECT imaging according to the Society of Nuclear     Medicine and European Association of Nuclear Medicine guidelines.      In this pilot study, an optimised acquisition protocol will be setup with SPECT/low-dose     multislice CT in addition to planar imaging.   "
225608|NCT00804557|"     To evaluate the ease of use and comfort of a new urinary catheter, the Uro-Ease, as used in     the Clean Intermittent Catheterization (CIC)process.   "
225609|NCT00804570|"     The Primary objective of this study is to test whether LY2196044 can reduce the number of     heavy drinking days per month in people with alcohol dependence. Each subject will undergo a     screening and assessment period (including medication washout) prior to randomization into a     16 week double blind treatment period.   "
225611|NCT00804596|"     The purpose of the study was to evaluate the acceptability of product user guides for     untrained subjects and to evaluate the performance of the system with lay users and     healthcare providers (HCPs).   "
225612|NCT00804609|"     To evaluate the levels of morphine in a patient's blood when morphine is given into the     epidural space in the form of DepoDur® either alone or following a dose of lidocaine also     given in the epidural space.   "
225948|NCT00810251|"     The purpose of this observational study is to document the treatment of serial rib fractures     with MatrixRIB implants in a registry.   "
225613|NCT00804622|"     The purpose of this study is to compare the safety, tolerability and effectiveness of 12     weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg once daily (QD)     taken together versus tenofovir DF 300 mg once daily (QD) or versus telbivudine 600 mg     monotherapy daily (QD). This is an open-labeled, active controlled, viral kinetics study     which means the subjects and study doctor will know what study drug subjects have been     assigned. This study is open to male and female subjects, <40 years of age, who have been     infected with HBV for at least 6 months and have not received oral treatment for HBV.   "
225614|NCT00804648|"     This study compares patient symptoms and anterior segment safety in patients treated with     timolol hemihydrate, generic timolol gel forming solution or timolol maleate.   "
225615|NCT00804661|"     The aim of the study is to identify the parameters that are associated with nocturnal     hypoventilation in children and adults with cystic fibrosis. Included patients will undergo a     nocturnal evaluation of their gas exchange and sleep quality by actigraphy during their     annual check up. The aim is thus to identify which parameters (such as lung function     parameters) are associated with nocturnal hypercapnia or hypoxemia and/or poor sleep quality   "
225616|NCT00804674|"     patients are given bupivacain intermittent locally on the donor site after brest     reconstruction with diep flap. The hypothesis was that this approach will reduce the need for     rescue analgetic medication and pain perception within the three first days   "
225617|NCT00804687|"     The purpose of this study is to evaluate the relative efficacy of JNJ- 39220675 and     pseudoephedrine compared to placebo (medication with no active ingredients) in participants     with allergic rhinitis (inflammation of the nose due to exposure to allergens such as pollen,     dust or animal hair).   "
225618|NCT00804700|"     The purpose of the study is to compare two different methods of listening to music while     performing aerobic exercise: synchronous music listening vs. asynchronous music listening.     Synchronous music listening while exercising is a learned activity where the participant     moves his or her body in synchrony with the beat of the music, similar to dancing or to     participating in a group exercise (aerobics) class. Our hypothesis is that synchronous music     listening reduces the level of perceived exertion to the exercise and motivates the subject     to exercise more often. This study randomly assigns 46 subjects, age 20-55 years old to     either a control group of listening to their own favorite music in an asynchronous fashion or     to an intervention group of listening to prepared music in a synchronous fashion over a six     week period.   "
225619|NCT00804713|"     The overall objective of this study is to assess the feasibility and potential impact of     using a targeted testing approach and 2 interferon-gamma release assays (IGRA) to screen for     latent tuberculosis (TB) infection (LTBI) among military recruits. The current policy of     universal application of the Mantoux tuberculin skin test (TST) to screen for LTBI may result     in many TST reactions among recruits who are at low risk for LTBI. The central hypothesis is     that targeted testing by use of the questionnaire will reduce unnecessary testing of low-risk     recruits without affecting the identification of higher-risk recruits. The secondary     hypothesis is that many discordant results between the TST and IGRA may be explained by     cross-reactivity to non-tuberculous mycobacteria (NTM) with the TST.   "
225620|NCT00804726|"     The objective of this 12-month clinical investigation is to evaluate the safety and     effectiveness of the Bausch & Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness     will be shown through the demonstration of accurate distance correction and safety will be     demonstrated through the monitoring of adverse events.   "
225621|NCT00804739|"     The purpose of this project is to test whether a new model of collaborative care depression     treatment adapted to the needs and preferences of low-income, urban mothers with perinatal     depression and to a pediatric clinic setting increases engagement in and adherence to     perinatal depression treatment.   "
225622|NCT00804752|"     We hypothesize that patients with Ch.HCV have a low level of vitamin D, and that by raising     their vitamin D levels by adding it to their standard treament of Pegylated Interferon and     Ribavirin, there will be an increase in their sustained virological response.   "
225643|NCT00805025|"     Over the 70-day study period, eligible patients visited the study clinic every 2 weeks (total     of 6 visits) and received a 28-day course of aztreonam for inhalation solution (AZLI). The     Quality of Life-Bronchiectasis (QOL-B) questionnaire was completed at several time points     during the study, in additional to pulmonary function testing and other standard procedures.   "
225623|NCT00804765|"     Metabolic environment of the foetus during pregnancy in obese women is altered and the child     exposed at an increased risk of obesity. Rapid infancy and childhood weight gain is     associated with subsequent obesity.      The purpose of the study is to test the efficacy of an educational intervention during     pregnancy in obese or overweight women, on the reduction of rapid infancy weight gain in the     two first years of life.   "
225624|NCT00804778|"     It's reported that USCOM can be used to measured patients' CO and CI conveniently, accurately     and not confined to place, because of it's no aggressive, it's accuracy is doubtful.   "
225625|NCT00804791|"     The objective of this study is to measure ocular surface residence time (in minutes) of two     marketed OTC ophthalmic products in dry eye patients.   "
225626|NCT00804804|"     The aim of the study is to determine the impact of aging, circadian rhythms and sleep     deprivation on executive performances. Volunteers will complete a 40-hour extended     wakefulness period in constant condition (semi-recumbent posture in bed, constant dim light     levels < 10 lux, food and liquid intake at regular intervals) in order to control the     circadian system. The volunteers will not be allowed to sleep in the sleep deprivation     protocol (high sleep pressure protocol) and will adopt a short wakefulness/sleep cycle     (150/75 minutes) in the multiple nap protocol (low sleep pressure protocol). Tests and     scales will be repeated every 3H45   "
225627|NCT00804817|"     This study will test the SCION (Self care improvement through oncology nursing)-HSCT program     a multi-modular, somatic-psycho-social care intervention to improve self management in     oncologic patients undergoing HSCT. The study will determine if the self management skills of     the patients to enhance:        -  physical activity,        -  prevention of oral mucositis and        -  mal nutrition during the period of hospitalization.      It is hypothesized that patients who receive the multi-modular somatic-psycho-social care     intervention will have better health related quality of life (HRQoL).   "
225628|NCT00804830|"     Anaplastic Thyroid Cancer is a very aggressive disease. The investigators believe that     angiogenesis is very important for these tumors to progress. Preclinical data is suggesting     this. This is why we we prospectively want to treat these patients with avastin (and     doxorubicin). However, local control is of major concern. Therefore, patients are initially     treated with hyperfractionated radiotherapy and undergo surgery. Then they can enter this     study.   "
225630|NCT00804856|"     The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I     part of the trial, BI 6727 will be investigated as monotherapy and in combination with low     dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for     intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated     dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients.     In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C     monotherapy will be investigated to explore the efficacy of the combination schedule in     comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible     for intensive treatment.   "
225631|NCT00804869|"     Ultrasonography has become a critical ancillary test in the clinical practice of     ophthalmology. It is commonly used as a standardized method for assessing intraocular     biometry. The PalmScan ultrasonography (PsU) is a portable A-scan device that uses the same     principles as the standard A-scan. The aim of the study is to compare the reliability of     their measurements, in order to use them indistinctively.   "
225632|NCT00804882|"     The investigators aim to examine how medical conditions that indicate high cardiometabolic     risk, such as increased body weight, high cholesterol levels and high blood pressure, affect     heart structure and function among individuals with known HF. Furthermore, this study is     being undertaken to identify potential differences in these effects between non-Hispanics     whites and Mexican Americans.   "
225633|NCT00804895|"     the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of     the greater occipital nerve to diminish the frequency of cluster headache (episodic or     chronic) attacks during an active period. Injections will be used in adjunct with oral     verapamil.   "
225634|NCT00804908|"     The purpose of this study is to evaluate the efficacy of ABT-888 in combination with     temozolomide versus temozolomide alone in subjects with metastatic melanoma.   "
225635|NCT00804921|"     Purpose: To evaluate the effects of anterior chamber paracentesis, brimonidine and oral     acetazolamide to reduce intra-ocular pressure (IOP) variations after intravitreal bevacizumab     injection (IVBV).      Methods: 47 patients scheduled for IVBV (1.5 mg / 0.06 ml) will be randomly assigned to a     pre-treatment 1 hour before IVBV with either 250 mg oral acetazolamide (DIA, 9 eyes),     anterior chamber paracentesis immediate after IVBV (PAR, 15 eyes), topic brimonidine     tartarate 1 hour before IVBV (BRI, 14 eyes), or no pre-treatment IBVB (CTR, 9 eyes). IOP will     be measured 90 minutes before injection (baseline), just before injection, and at 3, 10, 20     and 30 minutes after the procedure.   "
225636|NCT00804934|"     The purpose of this study is to determine whether people who have received intermittent     anti-VEGF therapy have an improvement in vision after being switched to monthly injections of     Lucentis.   "
225637|NCT00804947|"     Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen     for patients with Multiple Myeloma.   "
225638|NCT00804960|"     This research is being done to determine whether the success rate of in vitro fertilization     treatment can be improved, while lowering the cost incurred from infertility medications     using a pill called letrozole.   "
225639|NCT00804973|"     This is a Phase 2, multicenter, randomized, double-blind, placebo and active     comparator-controlled study of LY2590443 in approximately 200 subjects with migraines.   "
225640|NCT00804986|"     A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients     with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet     and exercise alone, or in combination with metformin, will be enrolled. The primary objective     of this study is to test the hypothesis that LY2428757 given to patients with T2DM     inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a     significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks     as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week     safety follow-up.   "
225641|NCT00804999|"     Assess the usefulness of using confocal microscopy to examine changes to the structure of the     cornea and to identify any potential consequences of contact lens wear and/or solution use.   "
225644|NCT00805038|"     Compared with chronic dialysis treatment, kidney transplantation generally offers a longer     life span, a better quality of life, and lower health care costs for the over 500,000     Americans with End Stage Renal Disease. Despite Medicare funding of virtually all kidney     transplants, minority, female, and poor patients with End Stage Renal Disease have decreased     access to kidney transplantation. In prior work, the investigators identified the steps in     the transplant process that are responsible for creating these disparities. These include     medical suitability, interest in receiving a transplant, referral to a transplant center for     a pre-transplant workup, placement on a waiting list or identification of a living donor, and     receipt of a kidney from a deceased or living donor. The investigators now propose to train     transplant recipients to act as transplant navigators and then test the value of using     transplant navigators to help patients and providers complete these steps.      The proposed community-based randomized controlled trial will involve approximately 75-100     adult hemodialysis patients at intervention dialysis facilities and approximately 75-100     patients at control facilities to compare a transplant navigator intervention with usual care     over a 24 month interval. Baseline evaluation will include sociodemographic and medical     characteristics, specific steps completed in the transplant process, and barriers to moving     forward in the transplant process. At periodic intervals, the navigator will provide tailored     information and assistance to patients and their nephrologists to help them complete the     tasks required at each step. The major outcome will be completion of additional steps in the     transplant process. Secondary analyses will examine impediments to successful intervention     among subjects who fail to move forward in the transplant process despite assistance from a     navigator.      The proposed project will test a novel intervention that targets patients and nephrologists     as they together make transplant-related decisions. Future work will involve determining the     impact of navigators on disparities in transplant rates, examining the cost-effectiveness of     transplant navigators, and disseminating the intervention for use across the country. Helping     patients complete steps in the transplant process may lead not only to improved access to     kidney transplantation but also to better patient survival, decreased health care costs, and     increased quality of life.   "
225645|NCT00805051|"     Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by     degeneration of the polymers during passage through the narrow valve leading to turbulences.     We hypothesized that the diagnosis of acquired von Willebrand syndrome influence     perioperative blood loss in patients undergoing open cardiac valve replacement.   "
225646|NCT00805064|"     The aim of this pilot study was to investigate the effects of an intravitreal combination     therapy using triamcinolone and bevacizumab in patients with retinal vein occlusion (RVO).   "
225648|NCT00805090|"     An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in     subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic     hepatic impairment compared. Additionally, the healthy adult volunteers will participate in a     randomized, open-label, crossover study in which they will receive Sporanox® to compare the     safety and pharmacokinetics of HPβCD when administered in DIC075V compared to Sporanox®.   "
225649|NCT00805103|"     Brain metastases occur in 20% to 40% of all patients with cancer , with an incidence 10 times     higher than that of primary malignant brain tumors. Patients with brain metastases have a     poor prognosis with a median survival of 1-2 months with corticosteroids and 5-7 months with     whole brain radiotherapy (WBRT). Local control achieved with WBRT in patients with otherwise     controlled systemic disease remains at issue. A single high dose of radiation delivered with     high precision to the target lesion (Stereotactic radiosurgery (SRS)), is considered standard     care in salvage of recurrent lesions after WBRT. SRS can destroy tumour with very little     damage to surrounding tissue. Research suggests that delivering radiotherapy in a number of     smaller doses is more beneficial than receiving all of the radiotherapy in a single dose.     Brain metastases are well suited for SRS as they are often small, radiographically     well-circumscribed, pseudospherical tumors that are noninfiltrative.   "
225650|NCT00805116|"     NSAIDS are associated with adverse GI effects and COX-2 inhibitors have cardiovascular risk.     Long-term oral supplementation with fish oil reduce e.g. joint pain in rheumatoid arthritis     (R.A) patients, with reduced need for NSAIDS, in addition to being cardioprotective. The aim     is to investigate if 4 month supplementation of 15 ml/day of whale blubber oil compared with     cod liver oil reduce the intensity of joint pain in patients with R.A (primary outcome).     Patients are assessed at inclusion and after study (4 months) during routine polyclinical     visit. Patients are called for interview after 6 and 12 weeks. Secondary outcomes are e.g.     morning stiffness, quality of life and functional level   "
225651|NCT00805129|"     The purpose of this study is to learn what effects, good and/or bad, Everolimus has on     advanced urothelial cancer.      The goal of this clinical research study is to learn if the study drug Everolimus can shrink     or slow the growth of urothelial cancer. The safety of this drug will also be studied. The     patients physical state, changes in the size of the tumor, and laboratory findings taken     while on-study will help us decide if Everolimus is safe and effective.   "
225652|NCT00805142|"     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the     drug is absorbed in the body, distributed within the body, and how it is removed from the     body over time; explores what the body does to the drug) of tapentadol prolonged release     (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and     spreads in the body until it kills) pain.   "
225653|NCT00805155|"     The purpose of this study was to compare the relative vasoconstrictive effects of two test     and one reference Mometasone Furoate 0.1% Topical Lotions in healthy, female subjects.   "
225654|NCT00805168|"     To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg     (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System     (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal     saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and     mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint     objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized     placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on     ventilation, and the days in the intensive care unit (ICU).   "
225655|NCT00805181|"     The objective of this study is to explore the kinetics of biomarkers in 30 adult female     patients with uncomplicated acute pyelonephritis.   "
225656|NCT00805194|"     The present trial will be performed to evaluate whether BIBF 1120 in combination with     standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more     effective as compared to placebo in combination with standard therapy of docetaxel. A     secondary aim is to obtain safety information as well as information on quality of life of     patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In     addition, blood will be collected for pharmacokinetic analysis.   "
225677|NCT00805480|"     Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing     single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to     severe chronic plaque psoriasis.   "
225678|NCT00805493|"     Pediatric Bipolar Disorder (BD) is uncommon in children. Its symptoms include periods of     manic behavior (being overly happy or giddy, feeling grandiose, feeling a decreased need for     sleep, having too much energy, moving more than usual, talking fast, having speeded-up     thoughts and other symptoms). Sometimes there also is depression (extreme feelings of sadness     or irritability, not taking pleasure in things, even ones that used to be enjoyable, feeling     worthless or guilty, sleeping too much or having trouble getting to or staying asleep,     feeling slowed down or restless, having wishes to be dead or suicidal ideas, and other     symptoms). Pediatric BD is often difficult to treat; children may respond only partially to     the medications now available or have too many side effects to tolerate them.      Riluzole is a medication that is thought to work on a brain chemical called glutamate that     may be involved in symptoms of depression and BD. Previous research studies have shown that     riluzole may help adults with BD who have depression and adults who have depression, anxiety     disorders, or obsessive-compulsive disorders. Riluzole may also be helpful for children with     obsessive-compulsive disorder. However, it has never been given to children with BD.      This study will evaluate the effectiveness of riluzole in 80 patients between 9 and 17 years     of age who have BD and symptoms of anxiety. Participants must have tried at least two other     medications that have not been effective.      The study will consist of four phases carried out over 4 to 5 months. Most children will be     inpatients at the Pediatric Behavioral Health Unit for at least part of the study.      In Phase 1, each patient will undergo blood and urine tests, and will gradually taper off his     or her medication. The duration of this phase depends on the medication that the patient was     receiving before starting the study.      In Phase 2, the patient will remain off all medication for 1 week. Throughout this time,     patients will be monitored carefully and medication will be restarted if needed.      In Phase 3, which lasts 8 weeks, patients will be assigned randomly to receive only riluzole     or only a placebo. Those who receive riluzole will have the dose adjusted as needed. Patients     and families will be informed of which drug they were on at the end of this phase. Patients     who improved on riluzole may continue to receive it from NIH for 1 month and will then be     prepared for discharge from the study. Patients who received placebo and improved, and those     who received riluzole but did not improve, will be treated with standard medications as     appropriate and prepared for discharge from the study.      Phase 4 is for patients who received placebo and did not improve. They will be given the     chance to try riluzole for 8 weeks and, if it is effective, continue it for an additional 4     weeks while they prepare to be discharged from the study.      Patients will not be able to receive riluzole at the National Institutes of Health after the     completion of the study. However, the child's doctor may be able to prescribe riluzole as an     off-label use.      Most patients will be admitted to the Pediatric Behavioral Health Unit at the National     Institutes of Health Clinical Center during the medication withdrawal part of the study     (Phases 1 and 2). From Phase 3 on, a patient may participate as an inpatient, outpatient, or     in day treatment, depending on what is in his or her best interests.      All participants in this study will be invited to also enroll in the National Institute of     Mental Health protocol 00-M-0198, The Phenomenology and Neurophysiology of Affective     Dysregulation In Children And Adolescents With Bipolar Disorder. Some research tests for that     protocol will be done during the medication-free period of this protocol.   "
225657|NCT00805207|"     Increased plasma triglyceride concentration is a common feature of the metabolic     abnormalities associated with obesity and a major risk factor for cardiovascular disease.     Obesity is a major risk factor for two conditions that appear to be increasing in prevalence     in women: the polycystic ovary syndrome and sleep disordered breathing. PCOS affects 5-8% of     women. Sleep disordered breathing affects up to 10% of women. Obstructive sleep apnea is the     most common cause for sleep disordered breathing and particularly prevalent in obese women     with PCOS (~50%). Both PCOS and OSA augment the increase in plasma TG concentration     associated with obesity, and the effects of polycystic ovary syndrome and obstructive sleep     apnea on plasma TG concentration appear to be additive. The mechanisms responsible for the     adverse effects on plasma TG metabolism are not known. The primary goal of this project,     therefore, is to determine the mechanisms responsible for the increase in plasma triglyceride     concentration in obese women with polycystic ovary syndrome and obstructive sleep apnea. It     is our general hypothesis that alterations in the hormonal milieu that are characteristic of     these two conditions are, at least in part, responsible for the increase in plasma TG     concentration in obese women with the conditions. Furthermore, we hypothesize that the     hormonal aberrations characteristic of the two conditions are particularly harmful to obese,     compared with lean, women.      The effects of PCOS on skeletal muscle protein metabolism are also not known. However, sex     hormones are thought to be important regulators of muscle protein turnover suggesting that     muscle protein metabolism is likely to be affected by PCOS. We will examine this by     determining the effect of individual sex hormones on muscle protein metabolism and     hypothesize that testosterone administration will stimulate muscle protein metabolism while     estrogen and progesterone administration will inhibit muscle protein metabolism.   "
225658|NCT00805220|"     The elderly are the fastest growing proportion of the population. Ageism implies a decline of     physical functions affecting functional and safe ambulation. Based on the ICF model     intervening in walking capacity could have favourable impact on quality of life of frail     elders. Over ground walking training is indicated as a possible exercise. However, to achieve     positive results on walking capacity, an exercise-dose response is needed. A more intensive     way of promoting walking training is to add skiing poles while walking, a technique called     Nordic Walking (NW). This study will be the first to compare NW with usual walking training.     It aims to estimate for frail elderly the relative efficacy in improving functional walking     capacity of two gait training strategies: NW and usual walking training and explore its     impact on fear of falling. This study hypothesized that participants receiving Nordic Walking     will walk longer, faster and fear less. NW if proven effective will positively impact on the     functional capacities and quality of life of frail elders and provide an more intense method     of walking training.   "
225659|NCT00805233|"     This open-label, randomized, Phase II research study will look to see whether an     investigational treatment combining bromfenac ophthalmic drops with ranibizumab intravitreal     injection is safe and effective for treating wet AMD as compared to ranibizumab alone.   "
225660|NCT00805246|"     Venous thromboembolism (VTE), which clinically manifests as deep vein thrombosis (DVT) and     pulmonary embolism (PE), is a common but elusive illness that can cause significant     disability and death if not promptly diagnosed and effectively treated. The annual incidence     of VTE in the United States is estimated at 1 per 1000. Death occurs in approximately 12% of     PE cases within 1 month of diagnosis. At present, clinical management of VTE and PE is     hampered by gaps in our understanding of pathogenic mechanisms, the wide variety in patient     populations, and incomplete understanding of the long term risks of recurrence and death.     Given the complex presentation and risk associated with these conditions, proper risk     assessment and subsequent prophylaxis for all at-risk patients is crucial. While clinical     prediction rules have been recently developed to associate short-term risks and to stratify     patients with acute PE, there is a dearth of objective biomarkers that can be related to the     long-term prognosis of the disease. In addition to clinical information, clot burden is known     to be strongly associated with clinical outcome of recurrent VTE. The quantification of clot     burden requires imaging.      CT Pulmonary Angiography (CTPA) has been established as a reference imaging standard in the     diagnosis of PE. In addition to its role as a superb diagnostic tool, CTPA contains a wealth     of information including characteristics of the clot that may be used as biomarkers     associated with prognosis of PE. The work proposed in this application takes advantage of     widely available CTPA imaging biomarker data and extends and advances clinical PE risk     prediction model to include long term (2-year) survival as well as the clinically important     outcome of recurrence. The primary objective of this proposal is to develop and identify CTPA     imaging biomarkers that are associated with short-term and long-term prognoses of patients     who were positively diagnosed for PE by CT. The rationale for this proposal is that CT     imaging is a rich source of imaging biomarkers that may be associated with prognosis of PE.     This information will help advance our understanding of the risk and recurrence of PE and     provide a new insight to prognosis and clinical management and treatment of PE. This proposed     research is innovative in that we have developed new CT imaging biomarkers and designed a     clinical trial to assess and validate the prognostic values of these biomarkers. Our central     hypothesis is that CT imaging biomarkers are associated with the risk of death and recurrence     in patients with PE. The specific aims of this proposal are: (1) to quantify and characterize     pulmonary emboli (volume and distribution) and comorbid cardiovasculopulmonary findings from     CT images of patients who were positively diagnosed for PE by CT; (2) to identify CT imaging     biomarkers that are associated with the prognosis of patients who were positively diagnosed     for PE by CT, and to develop risk prediction tools for death and recurrence; and (3) to     prospectively validate the risk prediction tool, and identify whether the change in CT     imaging biomarkers of PE after initiation of therapy improve the predictive ability for     recurrence and death.   "
225661|NCT00805259|"     In this between-subject randomized controlled trial the investigators will test the impact of     three novel structured financial incentives: atomistic, altruistic and team-based. These     incentive schemes will be used to motivate one month of daily use of software designed to     improve cognitive function (including memory, reaction times, attention and executive     function) among the elderly. The 400 participants will be members of retirement communities     in Pennsylvania. Three outcomes will be monitored and analyzed: activities completed using     the software (primary), performance on the activities, and changes in cognitive functioning.     This study is designed to be a pilot study. The investigators will have 90% power to find a     mean daily difference of 4 activities completed in the control group versus 7 activities     completed in the incentive groups assuming a standard deviation of 3.5 and an alpha of 0.017     (the bonferroni corrected significance level to account for multiple comparisons). In     addition during a three month follow-up period all participants will have continued access     to the software, however, no incentives will be provided for use. This period will be used to     assess the impact of the initial incentives on long run use after financial incentives have     ceased.   "
225662|NCT00805272|"     Tuberculosis is a current infection during HIV infection. After infectious contact, some     patients will develop tuberculosis some will only be infected without symptoms, they have     Latent Tuberculosis Infection (LTBI) which can reactivate later.In order to prevent this     tuberculosis reactivation, LTBI diagnosis screening is preconised in HIV-infected patients.     This diagnosis is made till now by the tuberculin skin test (TST) but this test is not     specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific po MTB infection are now sold     but have not been evaluated in immunocompromised HIV-infected patients.      The primary endpoint of this study is the evaluation of the theoretic therapeutic impact of     the use of IGRAS for diagnosis of LTBI in HIV-infected patients   "
225663|NCT00805285|"     The purpose of this study is to evaluate if the combination of oral budesonide and rectal     hydrocortisone improves symptoms in patients with active ulcerative colitis. Also, we would     like to determine if oral budesonide and rectal hydrocortisone has fewer and less severe side     effects compared to standard steroids (prednisone).   "
225679|NCT00805506|"     Evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to     identify periods throughout the day when glucose varies significantly.   "
225680|NCT00805519|"     This study was conducted to evaluate the efficacy and safety of prednisolone and chloroquine     add on therapies to combined glucosamine, chondroitin sulfate in osteoarthritis of the knee     which will be done in contrast to combined glucosamine sulfate and chondroitin.   "
225664|NCT00805298|"     The aim of this study is to compare postoperative complications after removal of lower third     molars using two different types of anaesthetics and two different treatments against     swelling and inflammation (methylprednisolone and placebo). The hypothesis is that a     combination of a long-duration anaesthetic combined methylprednisolone will result in     significantly less postoperative pain and inflammation.      Patients will have both lower third molars removed on two separate occasions. Each patient is     randomly assigned to receive one type of local anaesthetic the first time and the other type     the second time. Furthermore patients are randomised to receive either methylprednisolone or     placebo the first time and the opposite treatment the second time.      During the week after surgery patients fill out a questionnaire with questions about level of     pain and swelling at different times as well as the patients' perception of other     postoperative complications. The patient is examined by a dentist on the 2nd and 7th day     after surgery, where postoperative complications are recorded and thermographic images of the     patient's face are taken to assess the degree of inflammation.   "
225665|NCT00805311|"     The aim of this study is to determine whether optimal medical treatment can postpone carotid     endarterectomy.   "
225666|NCT00805324|"     The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius)     syrup in children with hayfever with or without asthma. Patients took desloratadine syrup     once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. The     doctor also rated how much relief the patient got from treatment and recorded any side     effects.   "
225667|NCT00805337|"     Following the discovery of tumor-specific frequencies in patients with advanced cancer,     compassionate treatment with tumor-specific frequencies administered at levels that are     significantly below the levels generated by cell phone will be offered to patients with     limited therapeutic options.   "
225711|NCT00800176|"     This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of     RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be     randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg     po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take     their usual dose of metformin throughout the study.The anticipated time on study treatment is     <=3 months   "
225712|NCT00800189|"     The purpose of this study is to determine if an alternative imaging protocol done at the time     of radiotherapy treatments for patients with breast cancer can improve accuracy in patient     set-up.   "
226143|NCT00813995|"     A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo     in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.   "
225668|NCT00805350|"     Primary objective:      - To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of     treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake     Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW).      Secondary objectives:        -  To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of          treatment on other sleep parameters measured by PSG recordings (Total Sleep Time -          PSG-TST, Sleep Efficiency - PSG-SE, Latency to Persistent Sleep - PSG-LPS) and reported          by patients (Wake Time After Sleep Onset - pr-WASO, Number of Awakenings - pr-NAW, Total          Sleep Time - pr-TST, Quality of Sleep - QoS and Refreshing Quality of Sleep - RqoS).        -  To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to          placebo.        -  To evaluate the effect of eplivanserin 5mg/day on daytime functioning using the Sleep          Impact Scale (SIS), as compared with placebo after 6 weeks of treatment.        -  To evaluate patient's impression of treatment effects using the Patient's Global          Impression questionnaire.        -  To evaluate the potential for next-day residual effects (using patient's morning          questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo.        -  To evaluate the potential for rebound insomnia following abrupt discontinuation of          eplivanserin 5mg/day in comparison with placebo.        -  To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of          patients with primary insomnia using the SF-36 Health Survey.        -  To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to          placebo.   "
225669|NCT00805376|"     The goal of this clinical research study is to find the highest tolerable dose of DNX-2401     that can be injected directly into brain tumors and into the surrounding brain tissue where     tumor cells can multiply. A second goal is to study how the new drug DNX-2401 affects brain     tumor cells and the body in general.   "
225670|NCT00805389|"     The aim of this Observer-blind study is to compare different Adjuvant Systems with the same,     well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B     (Engerix-BTM and FendrixTM), in order to better understand the immune response induced by     each of the Adjuvant System.      This Protocol Posting has been updated following Protocol amendment 6, October 2009. The     section impacted is Eligibility Criteria   "
225671|NCT00805402|"     The aim of this study is to show that flow cytometry can be an accurate tool to help     physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom     allergy.      75 patients having a story of reaction to hymenoptera venom will be selected for this trial.      Blood samples will be analyzed at: inclusion visit, Week 1 visit, Week 3 visit, Week 10 and     Week 21 visit.   "
225672|NCT00805415|"     The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral     contraceptive regimens.   "
225673|NCT00805428|"     Mucosal inflammation in patients with UC is the result of immunosuppression disturbance     because decreasing number of regulatory T ly and activation IL 17   "
225674|NCT00805441|"     H8R-MC-HJAQ is a Phase 2, parallel, double-blind, randomized study comparing LY686017 with     placebo in a 12-week trial that includes Medical Management. This study is an outpatient     study in which approximately 180 alcohol dependent subjects will be enrolled. Subjects will     be randomized in a 1:1 fashion to LY686017 or placebo, and will receive once daily dosing for     twelve weeks.   "
225675|NCT00805454|"     Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht     dose levels in healthy volunteers.   "
225676|NCT00805467|"     The purpose of this new research study is to gain additional information about how safe and     effective R935788 is over a longer period of time.   "
225681|NCT00805532|"     The present study is a randomized, controlled trial that compares Behavioral Activation (BA),     to Usual VA Care (UC) as early psychotherapeutic interventions for OIF/OEF veterans with     posttraumatic stress disorder (PTSD), or PTSD and major depressive disorder (PTSD/MDD).   "
225682|NCT00805545|"     The current standard of care to prevent post partum infectious morbidities is to administer     antibiotic prophylaxis to all women undergoing a cesarean delivery. The general practice is     to administer the antibiotic immediately after the umbilical cord is clamped. This study will     compare the incidence of post partum infectious morbidities when the extended spectrum     prophylaxis given before the incision time vs. the time of cord clamp.   "
225683|NCT00805558|"     The purpose of this study is to assess the clinical and microbiological effectiveness of the     moxifloxacin compared with the combination ciprofloxacin - metronidazole, when used as     adjunctive therapy to scaling and root planning for the treatment of advanced chronic     periodontitis.   "
225684|NCT00805571|"     The purpose of this study is to determine if measuring the level of a protein called Kidney     Injury Molecule-1 (KIM-1) in the urine will help healthcare providers detect any problems     with the transplanted kidney before the laboratory investigations that are used on a routine     basis do. This approach may allow the doctor to intervene at an earlier point of a rejection     episode and may thereby prolong survival of the transplant kidney.   "
225685|NCT00805584|"     The purpose of this study was to test the effectiveness and side effects of desloratadine     (Aerius) in patients with hayfever. Patients took desloratadine once a day for 15 days. At     the end of therapy, they scored how severe their hayfever symptoms were and how they     responded to therapy. Side effects were recorded.   "
225686|NCT00805597|"     The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer     patients with one to three positive nodes.   "
233984|NCT00920608|"     The main aim of this clinical study is to investigate whether the blood concentration of     methotrexate changes when AZD9056 is co- administered together with methotrexate.   "
225687|NCT00805610|"     The investigators research will examine the safety and efficacy of hepatocyte transplantation     in the patient with acute liver failure without history of chronic disease. The investigators     will study the effectiveness in providing a bridge of support for patient survival until     whole organ transplantation is possible. This support may also be a bridge to recovery; by     allowing the native liver to recover so that orthotopic liver transplant is not necessary.      The investigators will also study the safety and efficacy of hepatocyte transplantation in     the patient with chronic liver disease. Underlying etiologies of chronic disease may arise     from cirrhosis, fibrosis or inherited metabolic disorders. The investigators will examine     cell transplantation in end-stage patients not eligible for whole organ transplant. These     patients may benefit with an amelioration of symptoms that will allow other therapeutic     treatments.      The investigators study will also examine the ability of transplanted hepatocytes to treat     inherited metabolic diseases (ex., Crigler-Najjar Disease, Familial Hypercholesterolemia,     Urea Cycle Disorders). Cell transplant may also act as a 'bridge' to whole organ transplant     or improve function, permitting easier disease control through traditional therapy.   "
225688|NCT00805623|"     Sucking and sucrose have been shown to reduce pain during venous puncture in neonates. Our     study is designed to see if sucking and sucrose relieve pain during venous puncture in     infants age 3-12 months.   "
225689|NCT00805636|"     The purpose of this study is to evaluate the potential of [18F]-ML-10 to serve as an imaging     tool for the early detection of response of brain metastases to radiation therapy. Such early     detection may help early identification of responsive and non-responsive lesions. The     experimental design of the present study aims to evaluate the potential of PET imaging with     [18F]-ML-10 to address the currently unmet clinical need for very early (within one     day)assessment of response to therapy. Currently, response assessment is available only after     several weeks or months after completion of therapy, when tumor shrinkage can be detected by     anatomical imaging (by MRI). Early detection of tumor response to treatment is now     widely-recognized as a highly-desirable goal in oncology, and is respectively the target of     intense research worldwide. In the future, the option to know early upon treatment     administration, that the treated tumor is a non-responsive, may improve clinical management     of patients with brain metastases of solid tumors.   "
225690|NCT00799877|"     The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients     with Chronic Plaque Psoriasis (Ps).   "
225691|NCT00799890|"     The investigators hypothesize that an oral Sunphenon EGCg (Epigallocatechin-Gallat, EGCG)     treatment is - due to its antiinflamatoric and neuroprotective potence - significantly more     effective than an oral placebo treatment regarding following parameters: increase in brain     atrophy, number of new T2-lesions in the cerebral magnetic resonance tomography, reduction of     the NAA/Cr-ratio in MR-spectroscopy, progression of disability such as cognitive disorders in     patients with MS.   "
225692|NCT00799903|"     This study will test whether darapladib can safely lower the chances of having a     cardiovascular event (such as a heart attack or stroke) in people with coronary heart     disease.   "
225693|NCT00799916|"     Fluid resuscitation of severe sepsis may consist of natural or artificial colloids or     crystalloids. There is no evidence-based support for one type of fluid over another.      The investigators hypothesis is that fluid resuscitation with Voluven® is advantageous to     normal saline solution to improve sublingual microcirculation.   "
225694|NCT00799929|"     The purpose of this study is to compare two different in vitro fertilization (IVF)     treatments: conventional IVF protocol and minimal stimulation IVF protocol, in terms of     success rates, stress of treatment, drug-related side effects, multiple pregnancies and cost     of treatment.   "
225695|NCT00799942|"     The purpose of this study is to investigate the long-term safety, tolerability and efficacy     of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In     addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus     will be included.   "
225753|NCT00807677|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of TAK-901 in     subjects with advanced hematological malignancies, and to further assess the safety and     tolerability of TAK-901 at or below the MTD in an expanded cohort of subjects in order to     select a dose for future studies.   "
225696|NCT00799955|"     Summary Brief Summary Standard care for pain relief after cesarean delivery is spinal     morphine. Spinal morphine may be unsuitable for patients having general anesthetic or prior     morphine-related side effects and can be less effective in patients with morphine tolerance.     An alternative is a TAP block where local anesthetic is deposited between the abdominal     muscles consequently numbing the area and providing pain relief. The investigators believe a     TAP block will provide equivalent pain relief to spinal morphine.   "
225697|NCT00799968|"     Comparative trials of urokinase (UK) for 12 hours（UK-12h）or 24 hours (UK-24h) have produced     similar results in acute pulmonary thromboembolism (PTE) thrombolysis. It is unclear whether     the infusion time can be reduced further. The aim of this study was to investigate the     efficacy and safety of weight adjusted dosage of UK-2h (20 000 IU/Kg) regime with the Uk-12h     regime in selected patients with PTE in Chinese population.   "
225698|NCT00799994|"     A study to determine whether a patient's range of vision test results improve after their eye     pressure is lowered by 30% or more by testing on a new machine called the Accumap and how to     learn how much the Accumap's results change from one test to another within the same person.      The investigators believe that Multifocal VEP readings (Accumap)(and therefore visual     function and ganglion cell function) improve after acutely lowering intraocular pressure.   "
225699|NCT00800007|"     The purpose of this study is to evaluate the safety, immunogenicity, and antiviral effects of     multiple intravenous doses of ANZ-521 in patients with chronic Hepatitis C virus.   "
225713|NCT00800202|"     This study will assess the efficacy and safety of Avastin combined with first li ne     paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with     non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two     cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks     combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a     maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks     combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is     until disease prog ression, and the target sample size is 100-500 individuals.   "
225805|NCT00808353|"     The ARIC study is a prospective epidemiologic study conducted in four U.S. communities and     designed to investigate the etiology and natural history of atherosclerosis, the etiology of     clinical atherosclerotic diseases, and variation in cardiovascular risk factors, medical care     and disease by race, gender, location, and date.   "
225700|NCT00800033|"     The investigators specific objective is to determine the effectiveness of a pulse-based diet     combined with an exercise training program for reducing the risk of metabolic syndrome in     older adults. The metabolic syndrome is a cluster of risk factors that predispose one to the     development of diabetes and cardiovascular disease. These risk factors include increased     abdominal obesity, high blood triglyceride levels, low blood high-density lipoproteins, high     blood pressure, high blood glucose and insulin levels, and increased inflammation. The     investigators hypothesize that a pulse-based diet combined with exercise training will be     very effective for reducing the risks of the metabolic syndrome because each intervention     acts on different components of the metabolic syndrome.      The design will involve a randomized single-blind cross-over for the pulse-based diet, and a     single blind randomized parallel group assignment for the exercise-based intervention. 100     subjects will be randomized to receive the pulse-based diet or their regular diet for 2     months and then cross-over to receive the opposite diet for 2 months, separated by a     one-month wash out. Subjects will be further randomized to exercise or exercise placebo     groups for the duration of the trial (i.e. 5 months). The exercise intervention will involve     aerobic training as this is most effective for reducing metabolic syndrome risk.      Dependent variables will be measured at 4 time points: baseline, after the first 2-month     diet, before the second 2-month diet (i.e. after the washout) and at the end of the second     2-month diet. These variables will include: Serum triglycerides, high density lipoproteins,     C-reactive protein (as an inflammatory marker), glucose, and insulin, trunk body fat, and     blood pressure. A composite metabolic syndrome score will be determined by converting each of     these variables into Z-scores and determining the mean of these Z-scores. Secondary variables     will include other serum lipids, including low density lipoproteins and total cholesterol.   "
225701|NCT00800046|"     Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of     mitral valve regurgitation through subvalvular mitral repair.      Purpose: To demonstrate the safety, feasibility and potential efficacy of using the     AccuCinch® Ventriculoplasty System to reduce mitral valve regurgitation through subvalvular     mitral repair.   "
225702|NCT00800059|"     The investigators hypothesize that conformal radiation will allow the administration of     higher doses of external beam radiation to marrow based malignancies than total body     irradiation (TBI)without increasing the toxicity to normal tissues beyond that induced by     TBI. Further,the investigators hypothesize that this will result in an improvement in disease     response and disease control for patients with multiple myeloma. This is a dose escalation     study of TMI with the primary objective of determining the maximum tolerated dose of TMI when     followed by aHSCT in patients with relapsed or refractory multiple myeloma.   "
225703|NCT00800072|"     The purpose of this study is to evaluate the duration of oxygen use recorded by the NOWOX,     under usual conditions of daily living, in patients with chronic obstructive respiratory     disease requiring oxygen therapy.   "
225704|NCT00800085|"     This study will establish criteria indicating short-term loss of beta cell mass and therefore     accelerated progression towards type 1 diabetes.   "
225705|NCT00800098|"     Arthritis Relief Plus (ARP) Cream is a natural, herbal cream that has been shown to provide     pain relief and decreased stiffness. Anecdotal reports suggest that pain may continue to be     reduced months after cream use is stopped, indicating that there could be some     disease-modifying effects of the cream. The purpose of this study is to test the claim that     the ARP cream can provide long-term pain relief to osteoarthritis patients after only a short     period of use. The study will also try to determine whether the pain relief is accompanied     with any measurable indications that the progression of osteoarthritis has slowed or halted   "
225706|NCT00800111|"     Endothelial keratoplasty is a cornea-sparing transplant technique that replaces only the     diseased endothelial cell layer of the patient's cornea. This technique offers many     advantages compared with traditional full-thickness cornea transplants. Patients experience     minimal change in glasses prescription and usually recover useful vision within weeks. Visual     fluctuations are minimal during the healing process. The patient's cornea remains     structurally intact and is more resistant to injury.      Endothelial keratoplasty is undergoing rapid and widespread adoption. Between 2005 and 2007,     the number of corneas placed by US eye banks for endothelial keratoplasty increased ten-fold     (2007 Eye Bank Association of America Annual Report). However, the procedure is less than 10     years old, and little is known about long term outcomes. Endothelial keratoplasty candidates     at our center are invited to participate in an open enrollment, prospective study of the     long-term outcomes of this procedure.   "
225707|NCT00800124|"     The objective is to study the overall frequency and cumulative rate (during one year) of     clinical morbidity (defined as any hospitalization without fatal outcome) and mortality in     all consecutive patients undergoing HF surgery (pins and prosthetic implants) and compare     this to the group of patients receiving prosthetic implants and further find out if there is     a difference between the non-cemented and cemented groups.      Between the same prosthetic groups, the investigators want to study the overall frequency of     in-hospital subclinical organ damage and dysfunction of myocardium, liver and lungs, using     biochemical plasma markers. Finally, the investigators want to perform perioperative cost     benefit calculations and out of hospital quality of life analysis between the surgical     groups.   "
225708|NCT00800137|"     Many cardiac patients requiring device (defibrillator or pacemaker) related surgery are on     chronic oral anticoagulation therapy (usually coumadin). The risk of blood clot formation     related to stopping oral anti-coagulant therapy is currently managed by using bridging     heparin therapy in patients with moderate to high risk of blood clot formation. There is a     substantial risk of bleeding in the pocket where the device is situated (pocket     hematoma)related to bridging therapy. The purpose of this study is to compare the current     standard of care of bridging with heparin to an experimental strategy of continuing coumadin     therapy in higher risk patients undergoing device surgery, with the hypothesis being that the     continued oral anti-coagulation group will have a lower pocket hematoma rate as compared to     the bridging with heparin group.   "
225709|NCT00800150|"     RATIONALE: Giving total marrow and total lymph node irradiation together with low doses of     chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It     may also stop the patient's immune system from rejecting the donor's stem cells. The donated     stem cells may replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-tumor effect).      PURPOSE: This phase I trial is studying the side effects and best dose of total marrow and     total lymph node irradiation when given together with fludarabine and melphalan followed by     donor stem cell transplant in treating patients with advanced hematological cancer that has     not responded to treatment.   "
225710|NCT00800163|"     The investigators prospectively determined the impact on median door-to-balloon time of a     protocol mandating (1) emergency department physician activation of the catheterization lab     and (2) immediate transfer of the patient to an immediately available catheterization lab by     an in-house transfer team consisting of an emergency department nurse, a critical care unit     nurse, and a chest pain unit nurse.   "
225714|NCT00800215|"     The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given     as iv infusions compared with oral administration of the same dose strengths in subjects who     were receiving oral SPM 927 for partial seizures with or without secondary generalization.      Trial procedures will include medical history update, physical/ neurological exams, ECGs,     blood /urine sample collections and seizure diary completion.      Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM     927.   "
225715|NCT00800228|"     The purpose of this study is to test the hypothesis that blood pressure sensitivity to high     sodium intake in healthy humans is characterized by increased urinary excretion of two     endogenous sodium pump inhibitors, marinobufagenin (MBG), and ouabain-like compound (OLC).     The study also tests the hypothesis that women who breathe slowly and have high resting end     tidal CO2 at rest are more likely to have low plasma renin activity and sodium sensitivity of     blood pressure than those who breathe more rapidly and maintain lower end tidal CO2.   "
225716|NCT00800241|"     The purpose of this study is to determine the incidence of misuse, i.e., over-use and     under-use, of Budesonide/formoterol for maintenance and reliever therapy in usual-care     setting.   "
225717|NCT00800254|"     The purpose of this study is to determine whether early intervention with neuromuscular     electrical stimulation (NMES) for muscle strengthening immediately after total knee     arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in     quadriceps muscle activation, force production, and function in older adults.   "
225718|NCT00800267|"     Safety and efficacy study comparing between fixed combination latanoprost-timolol and its     component parts.   "
225719|NCT00800280|"     The purpose of this study is to estimate the effects of multiple doses of cimetidine on the     pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability     of PD 0332334 when co-administered with cimetidine.   "
225720|NCT00800293|"     The purpose of this study was to compare the relative vasoconstrictive effects of test and     reference topical augmented betamethasone dipropionate augmented 0.05% cream in healthy,     female subjects.   "
225721|NCT00800306|"     The present study was conducted as a prospective, randomized, controlled study to:        -  investigate the effects of a combination of levosimendan and inhaled nitric oxide on          systemic hemodynamics and microcirculation in patients with catecholamine-dependent          septic shock;        -  test the hypothesis that levosimendan plus inhaled nitric oxide may be effective in          restoring microvascular function in septic shock.   "
225722|NCT00800319|"     The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of     RDC-0313 following oral administration.   "
225723|NCT00805649|"     The purpose of this study is to investigate the efficacy of combined intravitreal therapy     with or without prior photodynamic therapy in patients with wet age-related macular     degeneration (AMD).      In patients with wet AMD, a significant improvement in vision was observed after combined     intravitreal therapy with or without prior photodynamic therapy. Both the pharmacological     effects of the drugs and the physiological effects of the pars plana vitrectomy (posterior     vitreous detachment, liquefaction, and oxygen redistribution) may have contributed to the     long-term sustainability of the therapeutic benefits.   "
225724|NCT00805662|"     Placebo-controlled study. Application of nasal oxytocin (8 IU) during intrauterine     insemination in 86 patients.   "
225763|NCT00807807|"     High levels of homocysteine, which is an amino acid in the blood, have been linked to an     increased risk of heart disease. This study will examine the effect that differing levels of     folic acid have on reducing homocysteine levels among older adults.   "
225957|NCT00810368|"     The purpose of this study is to perform a randomized double-blind, placebo-controlled, 12     week study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle     strength outcomes in 100 GWI subjects.   "
225725|NCT00805675|"     The purpose of this study is to compare the safety, tolerability and effectiveness of 12     weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD)     taken together vs. tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy     daily (QD). This is an open labeled, active controlled, viral kinetics study which means the     subjects and study doctor will know what study drug subjects have been assigned. This study     is open to male and female subjects, <40 years of age, who have been infected with HBV for at     least 6 months and have not received oral treatment for HBV.   "
225726|NCT00805688|"     The goal of this clinical research study is to learn about symptoms related to chemotherapy     and the disease, in patients with advanced pancreatic cancer. Researchers will study the     possible reason for these symptoms by drawing blood samples and comparing the test results to     the symptoms you experience. The study will also use a special telephone system for measuring     the symptoms of participants during and after therapy. Your level of physical activity will     also be studied using a pedometer and study diary.   "
225727|NCT00805701|"     Avodart (dutasteride) reduces the male hormone (DHT) that leads to prostate growth and     stimulates cancerous growth. Avodart is currently approved by the FDA to treat men with     symptoms of an enlarged prostate. Avodart works by reducing DHT and prostate size; therefore,     the drug may be useful in improving lower urinary tract symptoms (LUTS) such as frequency,     urgency, weak stream, and urination difficulty (dysuria), among others, in men with prostate     cancer. Avodart may be effective in men with prostate cancer who are being treated with     hormonal therapy with one injection of Zolodex (goserelin) followed one month later with a     trans-urethral incision of the prostate (TUIP), and three months after that, seed     implantation (SI) of the prostate.      The purpose of this study is to test whether Avodart (dutasteride) is effective on LUTS and     dysuria in men with localized prostate cancer being treated with single-dose goserelin, TUIP,     and interval SI.   "
225728|NCT00805714|"     Statins are usually used in AMI patients due to its strong anti-lipidemic effect, pleiotropic     effect and tolerable safety profiles. Generally AMI patients are prescribed many drugs     concomitantly; there are some risks due to the drug interaction. Especially, statins are     reported to have many drug interactions, these might influence to therapeutic prognosis and     safety in AMI patients.      This study is conducted to administer the non-CYP3A4 metabolized statin, pitavastatin to AMI     patients over 1 year, and the results will be compared with the other results from the KAMIR     study which is expected to the large scale of AMI patients using statins be enrolled.     Finally, from that comparison, we will investigate the influence of the statins metabolism by     CYP3A4 to the therapeutic prognosis like death, major adverse cardiac events(MACE), and major     ADR of statins like CK increase, myalgia.   "
225729|NCT00805740|"     The purpose of this study is to gather information on the use of anidulafungin for the     treatment of serious Candida infection. It is expected that anidulafungin will be at least as     safe and as effective as the comparator drug, caspofungin.   "
225730|NCT00805753|"     This pilot study is aimed at demonstrating the effectiveness of ACTH (H.P. Acthar Gel) on the     lipid profile and proteinuria in participants with MN. ACTH or adrenocorticotrophin is a     hormone produced by the pituitary gland (a gland at the base of your brain) that is involved     in stimulating your adrenal glands to secrete a number of steroid products (e.g. cortisol,     aldosterone, corticosterone, and others) that are important in keeping you alive. The drug     used in this study has been approved by the Food and Drug Administration (FDA) for routine     clinical use in the treatment of patients with proteinuria and patients with idiopathic     nephrotic syndrome such as idiopathic MN. However, the most adequate dose to use has not been     adequately assessed. This is the reason for conducting this research study.   "
225731|NCT00805766|"     The purpose of this study is to assess the efficacy, safety and pharmacokinetics after     administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an     insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.   "
225732|NCT00805779|"     To assess the initial safety and clinical feasibility of neuromodulation therapy in treating     patients with documented overactive bladder. The specific aim is improved urinary frequency     and urgency after 12 weeks of treatment   "
225733|NCT00805792|"     This study involves treating patients that have suffered an acute ischemic stroke with the     medication donepezil (Aricept ®). The hypothesis is that taking donepezil (FDA-approved for     the treatment of Alzheimer's Disease) for the first 90 days following a stroke enhances     recovery.   "
225734|NCT00805805|"     The University of Michigan is conducting a study investigating a potential new treatment     aimed at slowing/halting progression of primary biliary cirrhosis. This will be a 2 arm     double blind study in which half of the patients will be randomly selected to receive a     placebo (capsule with no active ingredient) and half will receive the new treatment drug,     tetrathiomolybdate. Neither the patient nor the treating physician will know which arm the     patient is in. The length of the study for each patient is 24 months of drug therapy. Lab     draws will be necessary weekly for the first 6 weeks of the study, followed by every other     week for 3 weeks, and then monthly for the remainder of the 2 year period. In addition,     intermittent history and physicals and urine samples will also be necessary. There is no cost     to you for any experimental treatment. All patients in both arms will continue on ursodiol     and receive standard of care treatment   "
225735|NCT00805818|"     The purpose of this study is to determine whether NNZ-2566 is safe and effective in the     treatment of Traumatic Brain Injury (TBI).   "
225736|NCT00805831|"     The HDH device is intended for creating sutureless vascular anastomosis in various blood     vessels. The HDH device consists of four parts: an elastic tube (graft), docking head     (anastomotic device), inversion device (connects the vascular graft to HDH) and measuring     device. This study was design in order to evaluate the safety and efficacy of using HDH     device and method an innovative anastomotic device for sutureless aortic anastomosis in     patient diagnosed with abdominal aneurysm or Aorto-iliac aneurysm.   "
225737|NCT00805844|"     To determine if using usual clinical practice plus a depth of anesthesia monitor, SedLine, to     guide anesthetic administration improves the quality and ease of MEP monitoring in patients     undergoing corrective spinal procedures.   "
226194|NCT00806546|"     This study will use an open-label design to evaluate the safety of NP101. Adult subjects who     meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic     transdermal patch) for acute migraine attacks over a 12 month period.   "
225738|NCT00805857|"     The SCOLTA project is a system for online surveying of adverse events to recently     commercialized antiretroviral drugs and a sentinel for unexpected and late adverse events     reactions arising during any antiretroviral treatment.Aim of the proposed study is:        1. to evaluate the prevalence and incidence of serious adverse events and serious          unexpected adverse events in HIV-infected patients enrolled in the SCOLTA project          Tipranavir cohort and to identify possible risk factors        2. the evaluation of tipranavir containing regimens durability, considering treatment          interruption for each reason.   "
225739|NCT00805870|"     The purpose of this study is to determine the effects of fish oil supplementation (Lovaza,     GlaxoSmithKline) on muscle strength, muscle soreness and inflammation following exercise.   "
225740|NCT00805883|"     This is a clinical research study designed to measure the effectiveness of focal Interstitial     Laser Thermal Therapy (ILTT) at killing prostate tumours. Patients with low risk prostate     cancer (Trans Rectal US Guided Biopsy positive) will undergo an MRI scan to try to localize     the tumour. If the MRI detects the tumour they will then undergo a perineal ablative     procedure (ILTT) under general anaesthetic. Seven days following ILTT they will come back to     the hospital for a Radical Retoropubic Prostatectomy (RRP) procedure, which is the removal of     a prostate gland through a surgical incision. After removal, the prostate will undergo     further analysis to determine the exact location of cancer and evaluate the extent of cancer     death caused by ILTT.   "
225741|NCT00805896|"     Songyou Granule is a mixture of 6 herbs. Vitro and vivo studies showed that Songyou Granule     can inhibit HCC cells grow, and HCC metastasis. Hypothesis of this study is that TACE plus     Songyou Granule will improve outcome in patients with advanced hepatocellular carcinoma (HCC)     compared with TACE.   "
225742|NCT00805909|"     The purpose of the study is to determine the safety and tolerability of NI-0401 and whether     NI-0401 can reverse BpACR.   "
225743|NCT00805922|"     This study is conducted in Asia. The aim of this observational study is to evaluate current     status of diabetes management, control, complications in diabetic subjects in Thailand.   "
225744|NCT00805935|"     This multicenter, randomized, open-label exploratory study will be performed in approximately     200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro     fertilization (IVF). Each study center will follow its standard practice for in vitro     fertilization (IVF) within the study parameters as noted in this protocol. The study centers     will use marketed products purchased from Schraft's Pharmacy for all phases of the study     (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be     randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim     Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil     for luteal support. Subjects will return to the study center for regular scheduled clinic     visits as required per in vitro fertilization (IVF) protocol at the site and at specified     times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and     first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic     gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at     completion of luteal support or negative serum pregnancy test following embryo transfer.   "
225746|NCT00805961|"     In this phase II trial the investigators plan to incorporate two targeted agents, bevacizumab     and everolimus, into the first-line multimodality therapy of glioblastoma. In the first     portion of the treatment, bevacizumab will be added to standard concurrent radiation therapy     plus temozolomide. After completing radiation therapy, patients will continue treatment with     the combination of bevacizumab and everolimus.   "
225747|NCT00805974|"     The primary objectives are to compare the mean levels of the sleep quality parameters of     subjects : with a nocturnal fall of the SBP (Systolic blood pressure), DBP (diastolic blood     pressure) and MAP (mean arterial pressure) over of egal to 10% (dipping subjects) and of     subjects with a nocturnal fall of SBP, DBP and MAP inferior to 10% (non dipper subjects).      The secondary objectives are :      Establish correlations between:        -  The quality of sleep parameters        -  The parameters of BP variations between the diurnal and nocturnal periods and the awake          periods of sleep defined in reference to polysomnography.        -  The glycemia levels on 24h with a glycemic holter. The parameters of the sympathic          system activation evaluated in reference to the measure of the baroreflex sensibility          during the awake period.   "
225748|NCT00806000|"     This study is investigating how commonly exercise-induced asthma happens in athletes and the     best way to diagnose exercise-induced asthma. Exercise-induced asthma describes narrowing of     the airways in the lungs that occurs in certain people when they exercise. This can cause     shortness of breath, cough, and fatigue during exercise and can impair athletic performance.     Exercise-induced asthma can be difficult to diagnose. This is a research study, because the     investigators are examining the best way to document a diagnosis of exercise-induced asthma.     The investigators are also interested in examining why exercise-induced asthma may occur.   "
225749|NCT00807612|"     This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study     designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and     carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.   "
225750|NCT00807625|"     In this study, 66 HIV-infected women who desire contraception will be randomly assigned to     use either an IUD or Depo Provera, and will be followed for six months. The study is intended     to help investigators understand potential mechanisms by which hormonal contraception may     hasten HIV disease progression.   "
225751|NCT00807651|"     This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within     the previous 6 months. The study is evaluating whether stem cell transplantation is safe when     chemotherapy and immunotherapy are used in combination and if it has immune resetting effect     that may halt the immune attack to pancreas islets and thus preserve the body's own insulin     production.   "
225752|NCT00807664|"     the objective of this investigation is to demonstrate the effect of the foam dressing Biatain     Ag, compared to Biatain foam dressing( a product which is similar but does not contain a     silver complex, in the healing of leg ulcers that had failed to heal despite appropriate     therapy   "
226273|NCT00814151|"     In-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and     methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's     bacteriophage-based diagnostic platform.   "
225754|NCT00807690|"     BACKGROUND Vitiligo is a common, often distressing condition. Many of the patients do not     achieve sufficient effect from what is regarded as the treatment of choice at present, narrow     band(NB)UVB(Tl01). There are reports on some patients partly successfully treated with     Tacrolimus ointment.      AIM OF THE STUDY We want to study whether Tacrolimus ointment may give an additive effect on     symmetric vitiligo in combination with NB-UVB.      METHODS This is a double blind left/right comparative study with 6 months treatment time.     Patients are treated with whole body NB-UVB x 2 or x 3 weekly, in addition to Tacrolimus     ointment versus placebo every night on affected half body sites. To measure effects we use     photodocumentation in addition to morphometric registration of symmetric target lesions every     6 weeks.   "
225755|NCT00807703|"     In the advanced stages of Parkinson Disease deep brain stimulation of the subthalamic nucleus     (STN DBS) is the next therapeutic option. Despite the beneficial motor effects there are     important negative side-effects of STN DBS. Our hypothesis is that changes in cognition and     behavior during STN DBS are related to stimulation of the non-motor parts of the STN.      The primary objective is to avoid cognitive and affective side effects by selective     stimulation of the STN motor part.      The main objective of this feasibility study is to measure the patients burden and to test     the technical feasibility.      Intervention:      The intervention is an expansion of the classical STN DBS procedure. The targeting using the     multichannel registration system by stimulation of the motor cortex and registration of the     subthalamic nucleus will be added to the procedure. For this procedure, it is necessary to     place a subdural strip under the skull.   "
225756|NCT00807716|"     Physiotherapy plays an important part in rehabilitation after total knee arthroplasty. Even     if this is a common practice, few studies have been performed on this issue.      The prime aim of this study is to examine the effects of an ambulatory individualized     task-oriented exercise program compared with current ambulatory physiotherapy(usual care)on     activity performance and self efficacy beliefs in the time span 6 weeks to 3 months after     total knee arthroplasty with a follow-up at twelve months.      HO:Task oriented physiotherapy has better effect than usual care on activity performance and     self-efficacy beliefs in the time span 6 weeks to 3 months after total knee replacement.   "
225801|NCT00808301|"     In many Northern European countries oat-based products have been used in the dieto-therapy of     coeliac disease for many years.      The purpose of this study is to evaluate clinical tolerance and liking of gluten-free     products containing oatmeal from a specific oat variety (not contaminated with gluten) in a     sample of Italian celiac patients in pediatric age.   "
225802|NCT00808314|"     Lexiscan(TM) has ideal properties for Rb-82 PET imaging and the stress response it invokes     may offer multiple advantages for the diagnosis of coronary disease and functional     abnormalities. The goal of this investigation is to establish quantitative equivalence of     Lexiscan(TM) rest/stress Rb-82 PET images to dipyridamole rest/stress images.   "
225806|NCT00808366|"     The purpose of the study is to evaluate the efficacy of RV4104A ointment versus     bifonazole-urea ointment for the complete removal of the clinically infected nail plate area     in patients with toenail onychomycosis.   "
225757|NCT00807729|"     Objective: We compared outcome parameters for good-risk patients with classic signs,     symptoms, laboratory and abdominal imaging features of cholecystolithiasis and     choledocholithiasis randomized to either LC + LCBDE or ERCP/S + LC.      Design: Our study was a prospective trial conducted following written informed consent with     randomization by the serially-numbered opaque envelope technique.      Setting: Our institution is an academic teaching hospital and the central receiving and     trauma center for the City and County of San Francisco.      Patients: We randomized 122 patients (American Society of Anesthesiologists Grade I or II)     meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol     violators having signed out of the hospital against medical advice before one of both     procedures were completed.      Interventions: Treatment was pre-operative endoscopic retrograde cholangiopancreatography     sphincterotomy (ERCP/S) followed by laparoscopic cholecystectomy (LC), or laparoscopic     cholecystectomy plus laparoscopic common bile duct exploration (LC + LCBDE).      Main Outcome Measures: The primary outcome measure was efficacy of stone clearance from the     common bile duct. Secondary endpoints were length of hospital stay, cost of index     hospitalization, professional fees, hospital charges, morbidity and mortality, and patient     acceptance and quality of life scores.   "
225758|NCT00807742|"     The aim of this study is to determine whether contingent reinforcement for smoking     abstinence, compared to noncontingent reinforcement, increases the effectiveness of brief     counseling and nicotine replacement on smoking abstinence of substance abusers in residential     treatment.   "
225759|NCT00807755|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as carboplatin and etoposide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) together with everolimus may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus,     carboplatin, and etoposide in treating patients with small cell lung cancer or other advanced     solid tumors.   "
225760|NCT00807768|"     This randomized phase III trial studies pelvic radiation therapy to see how well it works     compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating     patients with high-risk stage I or stage II endometrial cancer. Radiation therapy uses     high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material     placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as     paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading. It     is not yet known whether pelvic radiation therapy alone is more effective than vaginal     implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial     cancer.   "
225761|NCT00807781|"     The purpose of this study is to evaluate the safety of mammaglobin-A DNA vaccine in     metastatic breast cancer patients.   "
225762|NCT00807794|"     To evaluate the clinical safety of different doses of MEDI-507 through day 33.   "
226323|NCT00815412|"     A 3-year, randomized, controlled trial comparing a traditional worksite health promotion     program and an activated consumer program on health practices, health status and patient     activation measures.   "
225764|NCT00807820|"     This is a phase I study to evaluate the feasibility and safety of using MRI/MRS to identify     the dominant intraprostatic lesion (DIL) and to selectively boost the lesion using inverse     planned high dose rate (HDR) brachytherapy.      The main objective is to exploit the ability of MRI/MRS to identify cancer regions within the     prostate or the dominant intraprostatic lesions (DIL). The imaging data will be combined with     the treatment planning CT images to define a treatment plan that will boost the dose     delivered to the DIL up to 150% of the prescribed dose. Dose to the whole prostate and the     dose delivered to adjacent organs will not change. This is accomplished by using inverse     treatment planning software that can focus normally occurring high dose regions within the     target volume to coincide with the DIL.      After enrollment, each patient will have a MRI/MRS before starting treatment. Hormonal     therapy and external beam radiotherapy will be given based on current standard of practice.     During HDR brachytherapy, information about the location of tumor within the prostate will be     used to design the brachytherapy treatment plan. We will try to increase dose to DIL by     coincide existing high dose region on DIL using inverse planning software. Dose to prostate,     and adjacent structure will remain the same as the current treatment practice. Timing and the     delivery of brachytherapy will not change from our current practice. After the treatment,     each patient will remain on study and follow for 12 months and treatment toxicity will be     evaluated. A two-stage study design will be applied with a stopping rule for safety. Once a     patient comes off study he will be routinely followed for disease outcome and any late     toxicities.   "
225765|NCT00807833|"     It is a proof of concept study, aimed to evaluate whether the optimal CPP, defined by the     best PRx, corresponds to the acceptable CBF values in patients affected by CBF disfunction     caused by TBI or SAH.   "
225766|NCT00807846|"     This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib     (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic     Arthritis   "
225767|NCT00807859|"     The purpose of this study is to determine if AMG 386 in combination with either paclitaxel     and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with     HER2-positive locally recurrent or metastatic breast cancer.      This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose escalation     study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab     (cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of     the tolerable doses determined in part 1.   "
225768|NCT00807872|"     The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive     monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT     imaging in patients with AL amyloidosis.   "
225769|NCT00807885|"     The purpose is to evaluate the ease of use and technical challenges encountered during     subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human     hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery     systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these     delivery systems is also being evaluated.   "
225770|NCT00807898|"     Preventing cervical cancer is a public health concern. Since 2006 a quadrivalent vaccine for     young women nine to twenty six years of age has been available to protect against the human     papillomavirus (HPV) and to prevent some types of cervical cancer (Gardasil). The vaccine is     an important health promotion tool to address the widespread prevalence of HPV and cervical     cancer, but not all eligible young women receive the vaccine. The vaccine is most effective     when administered to young women before their sexual debut. When the vaccine is given to     young women less than 18 years of age, parental permission is required. This permission is     usually provided by the young woman's mother. Understanding predictors of a mother's decision     for her minor daughter to receive the HPV vaccine will inform interventions that seek to     increase the number of young women who receive the vaccine.      The study will focus on mothers and their adolescent daughters between 13-17 years of age. We     hypothesize that the Expanded Theory of Planned Behavior will explain a mother's decision to     choose the HPV vaccine for her daughter.      Research Questions include: 1)What TPB variables predict a mother's decision to choose HPV     vaccine for her daughter? 2)What variables predict the strength of a daughter's influence on     the mother's decision to choose HPV vaccine for her daughter? 3) What are the relationships     between the mothers' and daughters' scores on the variables related to the decision to choose     HPV vaccine? 4) How do the mothers and daughters who chose to receive the HPV vaccine differ     descriptively from those mothers and daughters who do not choose to receive the HPV vaccine?   "
225771|NCT00807911|"     The purpose of this study is to evaluate the disease-free survival in patients with locally     advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and     surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs     5-FU/Leucovorin.   "
225772|NCT00807924|"     The purpose of this patient tracking program is to monitor long term safety and effectiveness     of the Novilase™ device and method in real world application.   "
225773|NCT00807937|"     The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe     and effective in the treatment of generalized anxiety disorder.   "
225774|NCT00807950|"     We hypothesize that Simvastatin administration would result in selective killing of the basal     subtype of breast cancer, in particular, CD44+/CD24- breast cancer cells in primary tumor. We     further hypothesize that tumor genomic changes would correlate with tumor response to     Simvastatin. We are also looking to correlate Simvastatin biological effects with the     expression pattern of initial status of primary tumor. In addition, we hypothesize that     Simvastatin-induced tumor gene expression changes may correlate with tumor and plasma     proteomics, peripheral blood mononuclear cell gene expression changes, and pharmacogenetics,     and that these analyses may further refine the selection of patients most likely to benefit     from Simvastatin.   "
225775|NCT00807963|"     The purpose of this study is to determine the maximum tolerated concentration (MTC) of     bisphosphonate with a fixed dose of rHuPH20 administered SC, the MTC of bisphosphonate     without rHuPH20 administered SC, the optimal dose of rHuPH20 to deliver bisphosphonate SC at     MTC, and to compare the PK of SC administered bisphosphonate at MTC with optimal dose rHuPH20     to bisphosphonate alone.   "
244283|NCT01046903|"     The objective of this study is to observe the safety, tolerability, and compliance in the use     of Fragmin® for prolonged thromboprophylaxis in post-surgery high-risk orthopedic patients.   "
225776|NCT00807976|"     Rationale: Orthostatic hypotension increases with age and is associated with increased     vascular and all-cause mortality. The prevalence of orthostatic hypotension is also increased     in diabetic subjects. In order to prevent related adverse events and vascular mortality it is     of great interest to examine the prevalence of orthostatic hypotension in elderly diabetic     subjects.      Objective: To examine the prevalence of orthostatic hypotension and associated adverse events     in type 2 diabetic elderly subjects.      Study design: Cross-sectional observational study.      Study population: Elderly type 2 diabetic subjects (70 years and older).   "
225777|NCT00807989|"     To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and     Valproate. Low dose combination may be more effective and tolerable because they are low dose     and VPA reduce Lamotrigine metabolism.   "
225778|NCT00808002|"     The intensification with maraviroc in recently HIV-1-infected patients of a preferred     gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could     accelerate the decay of the HIV-1 reservoir in latently infected cells established early in     HIV-1 infection.      This could provide further insight into this area, decrease the size of latent reservoir, and     translate into clinical benefits for patients.   "
225779|NCT00808015|"     The purpose of this study is to describe the characteristics of the smoker who wants to quit     and his/her treating physician, in addition to determine the safety and effectiveness of     Champix in the real-world setting of smokers in routine clinical practice.   "
225780|NCT00808028|"     The purpose of this study is to evaluate the safety and immunogenicity of an investigational     meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.   "
225781|NCT00808041|"     The purpose of this study is to determine if dedicated breast computed tomography can be used     successfully to monitor tumor response in breast cancer patients undergoing neoadjuvant     chemotherapy.   "
225782|NCT00808054|"     In this randomized controlled study the investigators intended to compare analgesic effects     of EMLA and/or oral glucose in 60 preterm neonate during arterial function and PICC     installation.   "
225783|NCT00808067|"     The purposes of this study are:        1. To evaluate the long-term safety of dabigatran etexilate        2. To assess the effect of a knowledge translation intervention on patient outcomes   "
225784|NCT00808080|"     The aim of this protocol is to investigate a novel form of immune therapy for patients with     acute myelogenous leukemia (AML) who are in remission (CR) but who are at high risk for     relapse.   "
225785|NCT00808093|"     The purpose of this study is to compare the effects of fasting and fed conditions with repeat     doses of GSK256073F in HVT subjects.   "
225803|NCT00808327|"     The safest form of anesthesia for Cesarean section is a spinal anesthetic. All spinal     anesthetics contain a local anesthetic and/or a narcotic. A drug named bupivacaine is the     most commonly used local anesthetic in spinal anesthetics for Cesarean deliveries in North     America. Another drug named fentanyl is the most commonly used narcotic. This study will look     at whether a spinal anesthetic with 15mg of bupivacaine alone will be the same as a spinal     anesthetic with 12mg of bupivacaine and 15ug of fentanyl.   "
225786|NCT00808106|"     Oculocutaneous albinism (OCA) is a term used to describe inherited forms of hypopigmentation     associated with 1) variable levels of cutaneous hypopigmentation, ocular hypopigmentation,     and visual deficits, and 2) involvement of both of the major developmental types of pigmented     cells, i.e., melanocytes and retinal pigment epithelium. OCA that affects only     usually-pigmented tissues is termed isolated OCA. There are currently seven albinism types     (OCA-1 to OCA-7). With the exception of OCA-5, eash is associated with a specific gene and is     inherited in an autosomal recessive manner OCA-5 is a proposed type of albinism associated     with the chromosomal location 4q24. OCA-1 results from defects in the enzyme tyrosinase,     which catalyzes the rate-limiting step in melanin synthesis. The precise functions of the     remaining genes are not yet fully understood, but several may be associated with the     regulation of pH in the subcellular organelle where melanin in manufactured-the melanosome.     The majority of persons with OCA have two pathogenic mutations identified in a known     OCA-causing gene, but a substantial minority to not. Ocular albinism (OA) is an X-linked     disorder caused by mutations in the GPR143 gene. It affects the eye in a manner similar to     OCA, but has minimal or no skin manifestations.      In this protocol, we have four major goals:        1. To clinically and comprehensively characterize OCA types 1 - 7, and OA, with respect to          the degree of hypopigmentation, genetic mutations, extent of ocular involvement, and          longitudinal variation.        2. To use study participants cultured melanocytes to study pigment biology, variability in          pigment formation related to genotype, and response to proposed treatments. Some of this          work will be performed collaboratively.        3. To recruit study participants with hypopigmentation not due to known albinismcausing          genes.        4. To evaluate methods of quantifying eye pigmentation, skin pigmentation and other          clinical parameters that may be usable as outcome measures in future treatment studies.      To achieve those goals, we will perform clinical evaluations of persons with OCA and OA at     the NIH Clinical Center; obtain cultured cells, plasma, serum and urine for future studies;     and, perform mutation analysis on known OCA and/or OA genes and search for other genes     responsible for albinism. Routine admissions will last 3 - 4 days and occur every 2 - 3     years.   "
225787|NCT00808119|"     This is the first study to be conducted in humans for RTI-336, a new chemical entity, with     evaluations focusing on the safety, tolerability, and pharmacokinetics of RTI-336 following     administration of single, oral doses. RTI-336 is a novel dopamine transporter inhibitor of     the 3-phenyltropane class, and is currently being developed by RTI International as a     potential pharmacotherapy to treat cocaine dependence. Data from this study will be used to     plan and define dose ranges for subsequent studies.   "
225788|NCT00808132|"     The purpose of this research study is to evaluate the safety and effectiveness of this     investigational drug for the treatment of menopausal symptoms while protecting the     endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject     participation will last approximately 14.5 months.   "
225789|NCT00808145|"     This study will look at the safety and efficacy of treating advanced hepatocellular carcinoma     in patients who have not yet received systemic chemotherapy. Previous local treatment of     hepatic lesions is permitted The treatment will use a combination of three FDA approved     chemotherapy drugs, Gemcitabine, Cisplatin and Sorafenib. Sorafenib is FDA approved for the     treatment of hepatocellular cancer, gemcitabine and cisplatin are not approved for the     treatment of hepatocellular cancer.   "
225790|NCT00808158|"     Metabolic syndrome is a term that describes a group of conditions that increase the risk of     cardiovascular disease. The conditions include high blood pressure, obesity, and high     cholesterol. This study will examine how changes in tobacco exposure and weight can affect     the risk of developing metabolic syndrome among adolescents.   "
225791|NCT00808171|"     In this randomised controlled study the investigators intended to compare the analgesic     effects of EMLA and\or nitrous oxide in children submitted to lumbar puncture.   "
246979|NCT01077011|"     The purpose of this study is to compare the comfort and blurriness of an investigational     lubricant eye drop with a marketed lubricant eye gel.   "
225792|NCT00808184|"     The objectives of this study are:      To correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11)     and its metabolite SN-38.      To correlate the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan     and raltegravir pharmacokinetic parameters.      To model pharmacokinetic and pharmacodynamic behaviour of CPT-11 in the study population.   "
225793|NCT00808197|"     Age-related macular degeneration (AMD) is the chief cause of severe and irreversible loss of     vision in developed countries. The prevalence of AMD increases dramatically with age.      The early stage (or dry AMD) is associated with minimal visual impairment and is     characterized by large drusen and pigmentary abnormalities in the macula. The late stage is a     neovascular, exudative form. This so called exudative AMD includes serous or hemorrhagic     detachment of retinal pigment epithelium and choroidal neovascularization leading to severe     loss of vision (20/200 or worse). Patients with unilateral CNV (choroidal neovascularisation)     have a significant risk of CNV developing in the second eye.      Choroidal blood flow is of great importance for normal visual function. Several reports have     provided evidence suggesting that choroidal blood flow is decreased in subjects with AMD. In     late stages of AMD angiogenesis leads to the formation of choroidal neovascularization that     can cause severe visual impairment by disrupting normal macular function.      The purpose of this evaluation is to investigate a possible link between alterations in     choroidal blood flow and the development of CNV and serous detachment in the fellow eye of     patients with AMD and unilateral neovascular maculopathy. This longitudinal study may provide     important findings with respect to natural history and visual prognosis of patients with     neovascularized AMD.      Ocular blood flow will be determined by non-invasive methods, including laser Doppler     flowmetry and laser interferometry   "
225794|NCT00808210|"     This is a Phase II, randomized, active-controlled, double-blind, double-dummy,     parallel-group, multicenter study in the United States enrolling patients with active RA. The     study will enroll approximately 290 patients at approximately 130 sites.   "
225795|NCT00808223|"     To establish the safety of alefacept when administered to adolescent subjects with moderate     to severe psoriasis.   "
225796|NCT00808236|"     The purpose of the study was to demonstrate the safety and feasibility of early intranasal     cooling prior to return of spontaneous circulation (ROSC) in the emergency medical services     (EMS) environment. It was hypothesized that cooling during the resuscitation attempt would     increase ROSC and subsequent survival. The study was not powered to demonstrate     statistically-significant differences in any outcome parameter, but was intended as an     exploratory study only.   "
225797|NCT00808249|"     The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe     and effective in the treatment of generalized anxiety disorder.   "
225798|NCT00808262|"     Evaluation of the safety and the immune response induced by active immunization through a     TNFa kinoid in patients with Crohn's disease.   "
225799|NCT00808275|"     The purpose of this study is to determine the role of        1. dietary calcium in fecal fat loss and the association between lactose maldigestion,          dietary calcium level and source, and weight loss induced by caloric restriction.        2. caloric restriction on biomarkers of inflammation and oxidative stress   "
225807|NCT00808379|"     At Tata Memorial Hospital 50% of the patients present in the locally advanced stage which is     technically unresectable, or that is beyond the realm of a potentially curative surgical     resection. The evaluation of treatment approaches for these tumors is hampered by the absence     of any substantial randomized studies and the heterogeneous nature of the tumors at     presentation.      The management of these tumors has changed over the years, there is emphasis on neoadjuvant     chemoradiation therapy, trying to convert a tumor that is initially unresectable to one that     is potentially curable by surgery. But only 70-80% of the patients are able to complete this     treatment without any significant treatment breaks.      Dose escalated treatment with radiotherapy in locally advanced and unresectable rectal     cancers have been tried in many small series with good results and lesser toxicity.      Comparison outcome between the two arms will indicate the relative efficacy and toxicity of     neoadjuvant concurrent chemoradiation vs boosted radiotherapy alone in downstaging of     advanced cancers.   "
225808|NCT00808392|"     This study will investigate safety and immunogenicity of a monovalent conjugated vaccine     against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.   "
225809|NCT00808405|"     To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV)     shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a     history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to     receive episodic acyclovir 400mg orally three times daily or matching placebo three times     daily for 5 days and who are followed for a total of 13 days.   "
225810|NCT00808418|"     This aim of this study is to determine the safety and tolerability of elesclomol sodium at     escalating doses (ultimately identifying the maximum tolerated dose) when combined with a     fixed dose of docetaxel and concomitant prednisone. This study will also characterize the     pharmacokinetics of elesclomol and docetaxel.   "
225811|NCT00808431|"     Preventing the onset of pediatric obesity and diabetes in Latino families      The investigators will conduct a randomized controlled trial of a family-based community     centered intervention. One-hundred Latino families with children ages 3-5 will be randomly     allocated to either the intervention group (a 3-month skills building program to improve     nutrition and aerobic activity for child-parent dyads) or a control group (literacy     promotion). Through an active partnership with Nashville Metro Parks and Recreation and the     Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will:     1) Implement an intervention for Latino families with young children that includes parent     training, behavior modification training, nutrition education, and physical activity     promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3)     Evaluate how this intervention affects parenting practices for Latino families to improve     nutrition and physical activity; and 4) Evaluate the ability to link families into a     pediatric medical home if they have none identified. By developing innovative family-focused     interventions, finding solutions to health conditions such as obesity and diabetes could be     realized-con la familia.   "
226897|NCT00822874|"     A single centre randomised controlled trial investigating the influence of a novel     prematuration system (PMS) using a phosphodiesterase-3 inhibitor for in-vitro maturation of     oocytes - pilot study.   "
225812|NCT00808444|"     The purpose of the present study is to demonstrate that the changes in the manufacturing     process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no     clinical impact and that the immune responses are non-inferior to the immune responses     induced by the clinical lot. The study will be conducted in Singapore and Malaysia.   "
225813|NCT00808457|"     The study of a large number of patients (at least 200 patients) from several European centres     aims to investigate the value of chest ultrasound in diagnosing and checking the course of     pneumonia as compared to a chest X-ray film in two planes and - in case of a controversial     X-ray finding- as compared to low-dose CT.      An X-ray finding is regarded controversial, if infiltrates cannot be reliably excluded or not     reliably represented and if a definite diagnosis is, thus, not possible. A low-dose CT is     indicated even in case of a positive chest ultrasound and negative X-ray finding. Sonographic     recording and characterization of pneumonic infiltrates is performed both at the time of     diagnosing and in the further course under therapy.   "
225814|NCT00808470|"     Noise-induced hearing loss (NIHL) is a significant clinical, social, and economic issue.     Studies in animals have allowed us to identify mechanisms contributing to NIHL, including     direct mechanical trauma, free radicals formed in association with metabolic stress, and     reduced blood flow. A combination of antioxidant vitamins (beta-carotene, and vitamins C and     E) and the mineral magnesium (which acts in part as a vasodilator but also as an antioxidant)     is highly effective in preventing NIHL in animals. These studies evaluate efficacy of this     intervention in humans.      Hypothesis: Treatment with these micronutrients provides safe, effective attenuation of acute     hearing changes induced by exposure to real-world sounds producing temporary (non-permanent)     or permanent hearing changes induced by exposure to real-world sounds.      Experiment 1: Digital Audio Player studies (University of Florida, Gainesville). Prevention     of *temporary* elevations in hearing thresholds, induced by exposure to moderately loud     music, will be measured. Subjects will be 70 young adults with equal numbers of male and     female participants.   "
225815|NCT00808483|"     Rehabilitation plays an important part after total hip arthroplasty. In this common practice     few studies have been performed on this issue.      The aims of this study were:        1. to examine the immediate effects of a walking skill training program on walking, stair          climbing, balance, self-reported physical functioning physical functioning, pain and          self-efficacy compared to a control group without supervised physiotherapy        2. to examine whether the effects persisted 12 months after surgery   "
225833|NCT00808717|"     Although statin prior to PCI has favorable effects in stable angina and ACS except ST     elevation MI (STEMI), there have been few studies for STEMI. Celik T et al. reported in     patients with STEMI that prior statin use may improve coronary blood flow after PCI in     patients with AMI, possibly by its beneficial effects on microvascular function. But this     study was retrospective, non-randomized study and evaluated the effects for chronic statin     therapy not acute high dose effect. Therefore, the investigators investigated whether acute     high-dose statin prior to primary PCI in ST segment elevation myocardial infarction can have     beneficial effect or not for periprocedural period and 30 days-cardiac events.   "
225816|NCT00808496|"     Inflammatory arthritis is a major cause of permanent joint damage. Joint damage causes     functional disability and physical deformity. Many inflammatory arthritis patients develop     permanent joint damage within the first two years of disease. Early, aggressive treatment     with drugs called disease-modifying antirheumatic drugs (DMARDs) is known to reduce how     quickly this damage occurs. Sometimes, however, even when patients' symptoms are under     control, the disease continues to cause joint damage.      This study will determine if magnetic resonance imaging (also known as 'MRI') conducted every     six months provides arthritis specialists with information to help them better treat     peripheral inflammatory arthritis patients over the first two years of care. The effect of     MRI will be compared to 1) the use of x-ray every six months; and, 2) the frequency at which     these tests are usually used. The study will also determine if differences in treatment     between the three groups result in differences in the well-being of patients.      A total of 186 patients with early signs of inflammatory arthritis will be studied. All     participants will have an MRI and x-ray conducted every six months. One-third of participants     (62 in total) will only have MRI information sent to their arthritis specialist (MRI group);     62 will have x-ray information sent (X-ray group); and, the remaining 62 will have x-ray     information sent only when ordered by the arthritis specialist (Usual Care group). Negative     disease progression reports will be sent to the arthritis specialist unless intervention     allocation-specific disease progression is detected. In which case, a report blinded to     imaging modality will be sent indicating the detection of disease progression relative to the     last timepoint of progression, or baseline, as applicable. At any point in the study, the     arthritis specialist can request a clinical MRI or x-ray for any participant.      Neither the participants nor their doctors will know to which group they are assigned. A     computer program will randomly assign participants to one of the three groups using a     technique called minimization. This technique accounts for differences between participants     that are known to effect disease progression and treatment decisions. Using this technique,     participants with similar disease will be evenly distributed between the three groups.      The results of this study will have a direct impact on care for new inflammatory arthritis     patients. It will determine the benefits, if any, of regular monitoring of disease     progression with MRI or x-ray. Using tests proven to help treatment decision-making,     arthritis specialists will improve the care provided to new inflammatory arthritis patients.   "
225817|NCT00808509|"     The purpose of this pilot study is to investigate the possibility of discontinuing adalimumab     therapy in patients with rheumatoid arthritis who are in stable remission after treatment     with adalimumab in combination with methotrexate.   "
225818|NCT00808522|"     The purpose of the study is to evaluate whether hCG will result in a decrease in breast     density.      High breast density has been associated with an increased risk in breast cancer. It has also     been shown that decreasing density with a drug called tamoxifen has resulted in a decreased     risk in breast cancer. The investigators are looking at the effect of hCG on breast density     in people who are at increased risk of developing breast cancer and our theory postulates     that through the hormonal actions of hCG and tamoxifen there would be a greater reduction in     breast density in patients who are treated with hCG and tamoxifen versus patients treated     with tamoxifen alone. Using this data the investigators will be able to hypothesize that the     treatment of hCG will result in a reduction in breast cancer rates in the population and thus     make available another drug which can be used to decrease the rates of breast cancer in the     population   "
225828|NCT00808652|"     The relation between obesity and ischemic heart disease (IHD) is under considerable debate.     The reduction in all-cause mortality and, more specifically, the reduction in cardiac-related     mortality seen after weight-loss surgery, may be due to regression or slowing developement of     subclinical IHD. Function of cells lining the arteries (endothelium) is closely related to     the state of IHD and its measurement can serve as a surrogate marker for the existence and     severity of IHD. The investigators hypothesize that the prevalence of undiagnosed IHD in the     morbidly obese population is high and that following surgery for weight reduction there is a     halt in the progression, or even a regression in its severity.      The study includes measurement of endothelial function before and after weight-reducing     surgery.   "
248102|NCT01097083|"     The hypothesis of this study is that the median time to progression in the experimental arm     is 2 months as compared to the placebo arm of 1.4 months   "
225819|NCT00808535|"     The goal of this research study is to demonstrate that Cardiac Perfusion MRI with Vasomotor     Stress may serve as a non-invasive and less risky imaging technique for detecting     non-obstructive perfusion deficits and/or abnormalities in myocardial blood flow (MBF) in     patients with endothelial dysfunction.      This is a controlled study, which will enroll approximately 60 subjects (30 diabetics and 30     non-diabetics to serve as healthy controls), and will include male and non-pregnant females,     between the ages 18-50 years.      All eligible participants will sign an informed consent and will complete a Lifestyle     Questionnaire. They will undergo blood work which includes:        -  2-hour Oral Glucose Tolerance Test and Fasting Labs for Glucose, Insulin, C-Peptide,          HbA1c, Creatinine, and Lipid Panel.        -  Urine Albumin to Creatinine ratio for microalbuminuria.        -  Serum inflammatory markers: E-selectin, homocysteine, ADMA, VCAM, IL-6, TNFalpha, hs-CRP          and PAI-1.      After blood work, all participants will undergo cardiac MR perfusion imaging procedure with     Cold Pressor Test and Adenosine Stress Test.   "
225820|NCT00808548|"     Ask the 4 carers of children with Prader-willi syndrome to disclose their experiences and     difficulties for searching better management and intervention   "
225821|NCT00808561|"     The primary objective of this study is to compare two treatment strategies for establishing     dialysis access in patients with unsuitable forearm veins for the standard forearm primary     radio-cephalic arteriovenous fistula also known as the Brescia-Cimino fistula.   "
225822|NCT00808574|"     The current study was a pilot, double blind, randomized controlled trial to (1) evaluate the     feasibility of an online obstructive sleep apnea (OSA) screening intervention, (2) estimate     effect size for planning of future studies, and (3) test the hypothesis that the     intervention, compared to a control condition, would lead more individuals to discuss OSA     with their healthcare provider.   "
225823|NCT00808587|"     The specific aims for this project are to enroll up to 10,000 subjects who will have their     genomes surveyed using the Navigenics™ Health Compass technology. The Navigenics Health     Compass helps you understand what your genetic variants have to say about the future of your     health, and gives you action steps to take control of your health today. In addition, the     investigators will assess how the Navigenics Health Compass, results affect lifestyle     decisions. The phenotyping information that can be analyzed with the resulting Navigenics     genotype information will assist in identifying genetic variations associated with other     traits and diseases.      The uses of molecular markers such as cholesterol and glucose levels to assess disease risk     are well established in clinical medicine today. Although these tools are useful in screening     for subclinical disease, their predictive value is limited. Until recently, these molecular     markers were the best risk assessment and screening tools in existence. Since the completion     of the Human Genome Project, the era of personalized medicine, which exploits knowledge of     the genes an individual carries that may predispose him/her to disease, has come to the     forefront of research.      The Navigenics Health Compass technology assesses risk for about over 20 common diseases and     provides subjects with more accurate assessments of their individual predictive risk for     developing these conditions than traditional biomarkers such as cholesterol and glucose     levels. This may positively influence changes in lifestyle, as well as decisions to seek     further medical evaluation associated with preventive strategies.   "
225834|NCT00808730|"     Asthma is a frequent disease characterized by bronchial hyperresponsiveness, inflammation and     remodelling. Bronchial remodelling is an abnormal repair process that contributes to the     development of poorly reversible airway narrowing. It can appear very early in the evolution     of the disease and involves an increased mass of bronchial smooth muscle (BSM). The mechanism     of such an increase has been related with an increase in smooth muscle cell proliferation.     Recently, we have demonstrated that, BSM increased proliferation is induced by an enhanced     mitochondrial biogenesis in severe asthma (T. Trian et al. J Exp Med 2007). The objective of     this study is to investigate the role of smooth muscle cell mitochondria in non severe asthma   "
225824|NCT00808600|"     Lung or combined heart-lung transplantation represents an established treatment strategy for     patients with end-stage lung disease. Transplantation results in an increased exercise     capacity, a better quality of life and - depending on the pulmonary disease - a prolonged     life compared to the natural course of the pulmonary disease. However, even after successful     organ transplantation, patients realise the often inflated, unrealistic character of their     previous expectations due to their continuing dependence on medication, regular control     examinations and a higher risk of infections and allograft rejections. Patients have to cope     with erupting demands in family, social and work life. It becomes evident that their lives     have changed forever. In this context, limitations in mental health like depression and     reduced quality of life (QoL) as well as diminished compliance may emerge or even persist. By     five years post-transplant, about one-half of the patients meet the criteria of an anxiety     disorder. Symptoms of a clinically relevant depression or mood disorder occur in 10 to 15 %     of lung transplant patients.      In addition, patients after lung transplantation are often in a poor physical condition and     only hold a reduced functional status. Surgery itself, a prolonged weaning period during     mechanical ventilation, sepsis, and especially the immunosuppressive medication may     long-ranging or permanently limit physical activity, further reducing muscle mass and bodily     function.      Some positive effects of either psychological coping skills training or supervised exercise     therapy after lung or heart-lung transplantation on QoL and functional status have been     described in very few existing pilot studies with small numbers of patients and only     short-term follow-up. In addition, although clear evidence points to a mutual amplifying     effect of both psychological training and exercise therapy in patients coping with chronic     disease, no such study has yet been conducted in the transplantation field.      Therefore, the aim of the investigators randomised controlled study is to prove the     differential benefit of a multi-modal resource-activating behavioural training programme     combined with an intensified exercise training programme on functional status as well as on     QoL in a four-armed design. The investigators hypotheses are: (H1) The multimodal     resource-activating behavioural training programme will show better out-comes in the measures     of global health-related QoL compared to a relaxation group. (H2) Participants in the     intensified anaerobic exercise training will have better outcomes in the measures of     exercise-related variables and lung function than the group with moderate aerobic exercise     training. (H3) Participants in the behavioural intervention programme and the intensified     exercise training will have better outcomes in the measures of global health-related QoL and     exercise-related variables compared to the other groups.   "
225825|NCT00808613|"     The purpose of this study is to evaluate the differences in clinical outcomes between the     Optetrak® Posterior Stabilized (Optetrak® PS, Exactech, Gainesville, FL) and the Optetrak®     Hi-Flex™ (Optetrak® HF, Exactech, Gainesville, FL) knee designs. The null hypothesis is     that there is no difference in postoperative knee flexion between the Optetrak® PS and     Optetrak® HF groups.   "
225826|NCT00808626|"     99mTc-rBitistatin is a radiolabeled polypeptide which is designed to stick to blood clots so     that the blood clots can be detected by imaging. The purpose of this trial is to evaluate in     patients the safety of 99mTc-rBitistatin and its ability to locate blood clots in the arms     and legs.   "
225827|NCT00808639|"     The purpose of this research study is to test the effectiveness of neoadjuvant dose-dense     methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) in combination with     pegfilgrastim followed by radical surgery in patients with muscle-invasive urothelial     carcinoma.   "
225829|NCT00808665|"     Major lumbar spine surgery causes inflammation, soreness and swelling that can delay     discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory     effects. This study will evaluate whether DEX can help get patients out of the hospital     faster after major spine surgery by reducing the inflammation associated with the procedure     itself. A separate part of the study will evaluate the blood levels of some specific     indicators of inflammation called cytokines. Measuring cytokines before and after surgery     will aid in determining if DEX has altered the inflammatory response.   "
225830|NCT00808678|"     The purpose of this study is to evaluate the safety and compare the pharmacokinetic     parameters from the fixed dose combination ABT-143 relative to that from the     co-administration of the two monotherapies.   "
225831|NCT00808691|"     As medicine advances, many lives can be saved in the intensive care unit. However, when     multiple organ failure occurs, the mortality rate of patients increases dramatically.     Therefore, the major goal in the intensive care unit is to prevent the occurrence of multiple     organ failure. The sepsis protocol and early goal directed treatment have great effects to     reduce development of multiple organ failure and to decrease the mortality rate. However,     sometime the condition of patient deteriorated in spite of both the mean blood pressure and     mixed venous oxygen saturation are normal. Some experts recognize that there might be     microcirculatory dysfunction of tissue or organ. The dysfunction of microcirculation might     due to vasoconstriction or microthrombosis. Vasoconstriction might result from systemic     inflammation, reactive oxygen species, or dysfunction of synthesis of NO (nitric oxide).     Microthrombosis might result from systemic inflammation, reactive oxygen species, imbalance     of coagulatory system, or damage of endothelial cell.      In clinical practice, the oxidative stress is related to circulatory shock, sepsis, acute     lung injury, and acute respiratory distress syndrome. This study tries to investigate the     relation between oxidative stress and microcirculation. Furthermore, the investigators will     try to investigate the correlation between the severity of oxidative stress and     microcirculatory dysfunction and the severity of disease and prognosis. The investigators     hope this study will help them to figure out the picture of disease progression of patients.     It may conduct further study to modulate the oxidative stress, to improve the     microcirculatory function, and finally to improve the outcome of patients.   "
225832|NCT00808704|"     Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and     mortality in term and preterm neonates, accounting for 23% of neonatal deaths globally.     Although many neuroprotective strategies appeared promising in animal models, most of them     have failed clinically. Erythropoietin (EPO) is an endogenous cytokine originally identified     for its role in erythropoiesis. Clinical trial has demonstrated the safety and efficacy of     recombinant human erythropoietin (r-hu-EPO) in the prevention or treatment of anemia of     prematurity. To date, there are no reports evaluating possible effects of EPO on neonatal     HIE.   "
225835|NCT00808743|"     Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous     Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is     to determine wether celecoxib combined with ursodeoxycholic acid is an effective     chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in     patients with FAP.   "
225838|NCT00808782|"     Theory of mind (ToM) refers to the ability to infer others mental states. It includes a     recognition that other individuals experience thoughts, feelings, intentions, and desires     that may be different to our own. ToM is often impaired among individuals with an autism     spectrum disorder (such as autism and Asperger's disorder), and may underlie aspects of     social dysfunction in this population. Indeed, it has been suggested that impaired ToM is the     core deficit of autism and Asperger's disorder.      Imaging studies suggest that the bilateral medial prefrontal cortex, the most important brain     region in ToM processing, is underactive in autism. The current study examines whether     repetitive transcranial magnetic stimulation (rTMS) to the bilateral medial prefrontal cortex     can modulate ToM ability among healthy adults, and improve ToM ability among adults with     autism or Asperger's disorder. With the prevalence of autism increasing, there is a clear     need to develop appropriate therapeutic interventions to improve social functioning.      This study involves a double-blind study using high-frequency rTMS in an attempt to improve     ToM among adults with either autism or Asperger's disorder. Theory of mind will be measured     using behavioural tasks that require the participant to infer what someone is thinking or     feeling by observing their behaviour. These tasks will administered both before and after     rTMS to determine whether any change in theory of mind has occurred.      Thirty adults with either autism (n = 15) or Asperger's disorder (n = 15) will initially     undergo functional and structural MRI to determine the site on the scalp that lies over the     medial prefrontal cortex (to which rTMS will be administered). They will then attend our lab     each consecutive weekday for a two-week period, during which they will 15 minutes     high-frequency (5 Hz) rTMS (either active or sham) to the medial prefrontal cortex. ToM and     clinical measures will be collected before the first session, soon after the last session,     and one month after the last session.      Based on prior imaging data, it is expected that high-frequency rTMS (compared with sham     rTMS) to the medial prefrontal cortex will improve ToM ability and reduce social dysfunction     among adults with autism or Asperger's disorder. Should these hypotheses be supported, it     will indicate the suitability of rTMS as a neurobiological intervention designed to improve     ToM and social function among individuals with autism and related disorders.   "
225839|NCT00808795|"     -  Contrast-induced nephropathy (CIN) is the third most common cause of hospital acquired          acute kidney injury, accounting for 10% of all cases.        -  The pathophysiology of CIN is unclear. Possible mechanisms involve             1. Renal tubular injury by oxygen free radicals             2. Reducing renal blood flow which leads to acute tubular necrosis. Since               N-acetylcysteine is an antioxidant as well as a vasodilator, it may work in two               distinct ways, by preventing reduction in renal blood flow or contrast-induced               oxidative damage.        -  The purpose of this study is to evaluate the efficacy of N-acetylcysteine compared to          placebo for the contrast-induced nephropathy prevention.   "
225840|NCT00808808|"     The purpose of this study is to determine, among adults and in the total population, the     effects of offering a choice of FluMist or trivalent inactivated vaccine (TIV) in the     employer setting when compared to a control group.   "
225841|NCT00808821|"     The study is aimed at assessing pharyngeal and nasopharyngeal Streptococcus pneumonia     carriage and pharyngeal Group A streptococcus carriage among field units new recruits.   "
225842|NCT00808834|"     The purpose of this study is to compare subjective responses to two contact lenses after 15     minutes of wear.   "
225843|NCT00808860|"     The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract,     administered as a tea, as add-on therapy with Sulfonylurea (SU) in drug-naive patients with     newly diagnosed type 2 diabetes. After screening, all patients received gliclazide MR 30mg     and instruction regarding diet and physical exercise for 12 weeks. After 4 weeks treated with     gliclazide MR 30mg, the patients was randomized to additional GP tea or placebo tea, 3 g     twice daily during 8 weeks. Oral glucose tolerance tests were performed at baseline, after 4     and 12 weeks. Blood tests were taken with the purpose to monitor lipids, kidney and liver     function.   "
225844|NCT00808873|"     Compared to a treatment-as-usual group, providing brief mental health education to suicide     attempters from rural parts of China at the time of their treatment in the emergency     departments of general hospitals or local clinics and 6 home-visits (FOR those subjects WITH     PHONES refuse home visits, THE INTERVIEWS WILL BE CONDUCTED OVER THE PHONE) over the twelve     months after the attempt demonstrate continuing concern about the attempters ('befriending'),     strengthen their social support networks and improve their problem-solving skills will     significantly reduce their hopelessness, the severity of depressive symptoms, and level of     suicidal ideation.   "
225845|NCT00808886|"     Hypothesis: There is no difference between pentacam scheimpflug system and locs3 in grading     of cataract.      Major aims:        1. research the efficiency of pentacam scheimpflug system in lens density measurment.        2. To compare the pentacam with the locs3 in grading of cataract.   "
225846|NCT00808899|"     A Phase II study of temsirolimus in combination with standard chemotherapy (irinotecan;     cyclophosphamide, doxorubicin and etoposide (CAE); cisplatin and etoposide (HiPE) and     topotecan (TPT) followed by and additional six courses of induction chemotherapy and then     intensification with autologous hematopoietic stem cell transplantation. The first five     courses of induction chemotherapy will also evaluate the feasibility of combining weekly     temsirolimus with these standard chemotherapy combinations. This will be followed by 16     months of oral maintenance therapy with eight months of 13-cis-retinoic acid and then eight     months of oral topotecan.   "
225847|NCT00808912|"     The purpose of this study is to examine if the ingestion of a standard dose of sildenafil     enhances the athletic performance of competitive athletes when exercising in a high pollutant     environment verses a low air pollutant environment.   "
225848|NCT00808925|"     There is growing evidence to conclude that part of the cascade leading to heatstroke is     related to an inflammatory reaction triggered by the heat stress. The reduced ability to     sustain heat stress - heat intolerance is also attributed to over-expression of     inflammatory cytokines. Acclimation to heat improves human sustainability to heat and is a     leading protective factor against heat stroke. The investigators hypothesize that the lower     stress encountered during the process of acclimation to heat will be reflected by an     over-ride in the expression of anti-inflammatory over the pro-inflammatory cytokines. This,     in turn will attenuate the pathological cascade leading to heat stroke.   "
225873|NCT00809250|"     The purpose of this research study is to determine if the GM-K562/leukemia cell vaccine can     be safely given soon after allogeneic marrow or blood stem cell transplant. The     GM-K562/leukemia cell vaccine is composed of a cultured cell line that has been genetically     modified to secrete GM-CSF, a naturally occuring substance in the body that stimulates the     immune system. The vaccine is a mixture of the GM-K562 cells (radiated to prevent them from     growing in the participants body) with the participant's previously frozen and killed     leukemia cells. By mixing the GM-K562 with the leukemia cells, we would like to study whether     this vaccine combination will stimulate the participant's new immune system to recognize and     fight against their MDS/AML cancer cells.   "
226189|NCT00806481|"     The purpose of this study is to determine whether lowering phosphate in patients with early     chronic kidney disease with the phosphate binder sevelamer has beneficial effects on     cardiovascular structure and function.   "
225849|NCT00808938|"     Electro convulsive therapy (ECT) remains the only established therapy for the large     percentage of patients with depression who fail to respond to standard treatments. It is     commonly used but has substantial problems including the occurrence of cognitive side effects     that are often highly distressing for patients. The development of a new treatment with     similar efficacy but which minimises these side effects would have great clinical value. One     highly promising possibility is magnetic seizure therapy (MST). MST involves replacing the     electrical stimulation used in ECT with a magnetic stimulus. This appears to be able to     produce similar clinical effects but without the disabling cognitive side effects related to     ECT. However, substantive trials using the newest MST equipment are required. Due to the     rarity of the equipment available so far, these are only being undertaken in a handful of     places internationally and no research with MST has occurred in Australia. The investigators     are fortunate to have been able to obtain one of the very limited number of MST devices     available internationally and are proposing a pilot study of this technique. Conduct of a     successful pilot study would be strong justification for an application for a large     head-to-head MST - ECT comparison trial. Should MST be shown to have similar efficacy to ECT     but with reduced side-effects, it is envisioned that it could rapidly replace ECT in clinical     practice throughout Australia and indeed internationally with substantial ongoing benefits to     patients. These would include enhanced use of it as an outpatient therapy as well as the     reduction in side-effects.      The study will be an open label trial of MST in 15 patients with treatment resistant     depression who have been referred for ECT. All patients will undergo a dose titration     procedure to establish seizure threshold, six MST treatment sessions will then be provided at     120% of threshold. If the patients have not achieved a 50% reduction in their depressive     symptoms (as measured by the Montgomery Asberg Depression Rating Scale rating scale) patients     will receive another 12 sessions. MST will be administered three times a week. Patients will     undergo a series of assessments to determine both the efficacy of MST and the cognitive     outcomes. The primary outcome measure will be the MADRS measure of depression severity. The     investigators will additionally measure patient rated depression severity and cognitive     functioning The overall aim of the current project is to, via an open label pilot trial,     investigate the clinical response to magnetic seizure therapy in patients with treatment     resistant depression who have been referred for electroconvulsive therapy.   "
225850|NCT00808951|"     Resistance to antimalarial drugs represents a major obstacle for controlling malaria in     endemic countries, so that most sub-Saharan countries have changed their antimalarial drug     policy to the new Artemisinin Containing Therapies. Burkina Faso has changed its policy for     uncomplicated malaria to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS), but     there are still little available data on safety and efficacy of these treatments in Burkina     Faso; both treatments have shown to be efficacious, but AL seems to have higher occurrence of     recurrent malaria infections during a 28-day follow up period. Thus, this study aims at     comparing the safety and efficacy of AL and AS-AQ (42-day follow-up), AND also at comparing     their in vitro sensitivity, in patients with recurrent infection, with the results obtained     in vivo.   "
225851|NCT00808964|"     This is a Phase 2, multicenter, open-label, single-arm, sequential cohort study to be     conducted in up to 30 subjects. The study will evaluate subjects undergoing primary,     elective, off-pump CABG surgery with median sternotomy.   "
225852|NCT00808977|"     The purpose of the study is to obtain a first clinical assessment of the safety of     dersalazine sodium in ulcerative colitis patients with mild to moderate disease.   "
225853|NCT00808990|"     Nonalcoholic Fatty Liver Disease (NAFLD) has been suggested to be the most common cause of     chronic liver disease in the general population in the Western World. In advanced stages of     NAFLD, steatohepatitis (NASH) develops characterized by: steatosis, inflammation, and     fibrosis progressing to cirrhosis in some patients. The knowledge of the role of small     intestinal bacterial overgrowth (SIBO) in the pathogenesis of NASH has led to the proposal of     probiotics as a therapeutic strategy for this disorder.   "
225854|NCT00809003|"     This project will examine the similarities and differences of the ocular surface and tear     film in patients with Sjogren's syndrome related to dry eye, severe dry eye and those who do     not have dry eye. This knowledge will help clinicians understand the processes that create     these dry eye conditions and will strengthen the treatment and management strategies that     will be used. The subjects will participate in a series of dry eye tests that they have     already experienced in clinic, along with the gathering of tear samples and surface cells.     These tissues will then be analyzed at a distant site.   "
225855|NCT00809016|"     RATIONALE: Imaging procedures, such as PET scans, may determine the extent of cancer and help     doctors plan radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor     cells. Giving radiation therapy that uses a 3-dimensional image of the tumor to help focus     thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses     over a shorter period of time, may kill more tumor cells and have fewer side effects.     Specialized radiation therapy that delivers a high dose of radiation directly to the tumor     may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This clinical trial is studying PET scans to see how well they work in patients with     head and neck cancer who are undergoing 3-dimensional conformal radiation therapy and     intensity-modulated radiation therapy.   "
225856|NCT00809029|"     Study part-1      GIP (glucose-dependent insulinotropic polypeptide) is one of the two main incretin hormones     secreted by specialized cells of the gastrointestinal tract in response to ingestion of     nutrients. Data emerging from studies in animal models and cultured human fat cells support a     physiological role for GIP in the adipose tissue metabolism which may contribute to the     pathogenesis of obesity.      The proposed study will shed more light on the interactions between gut hormones and adipose     tissue. For this pilot study, male subjects fulfilling the inclusion criteria will be given     GIP or placebo infusions in a randomized manner. Fat tissue biopsies will be obtained from     all subjects during both visits, once in the basal state (before the start of the     peptide/placebo infusion) and then repeated at the end of the period of infusion.      Study part-2      Surgery represents the most effective therapeutic modality for morbid obesity. Resolution of     type 2 diabetes mellitus (T2DM) has been consistently observed as an additional benefit of     surgical treatment of obesity. The mechanisms underlying the dramatic effects of surgery on     insulin sensitivity and β-cell function are poorly understood. Bariatric surgery (gastric     bypass) promotes changes in the enteroendocrine system as a result of nutrient diversion from     the physiological intestinal routes with subsequent profound modification of gut hormone     secretion      We hypothesize that restoration of GIP action after bariatric procedures plays a cardinal     role in the improvement and/or restoration of diabetes, we propose to study patients (both     sex)with morbid obesity and T2DM within 3 months after their surgery. Their responses will be     compared to those of BMI matched control subjects with normal glucose tolerance   "
225857|NCT00809042|"     The purpose of this study is determination of the efficacy of combination of hydroxyurea with     L-carnitine or magnesium in improving hematologic parameters and cardiac status in patients     with β-thalassemia intermedia in comparison with hydroxyurea alone .   "
226190|NCT00806494|"     To explore the effects of fesoterodine when used in a flexible dose manner   "
233985|NCT00920621|"     Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and     children.   "
225858|NCT00809055|"     Over the last 30 years the survival rates for babies born prematurely have improved greatly     with research. As these babies grow up, we have found that many of the premature babies have     learning and movement problems. The purpose of this research is to learn why premature     infants are at risk for learning disabilities and movement problems later in childhood and     whether this is changed by caffeine therapy. Caffeine is often used in premature babies to     help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive     caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown     that caffeine therapy given to premature babies reduces their disabilities.      We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance     imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine     in high doses enhances protection of the developing brain. Just as we monitor the heart and     lungs to improve our care of premature babies, we wish to monitor the brain so that we can     understand how to improve our care for the brain.   "
225859|NCT00809068|"     Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%.      This study aims to study the effects of fenofibrate on HDL and subfractions in women taking     tibolone.   "
225860|NCT00809081|"     Pancreaticoduodenectomy is associated with a high incidence of postoperative complications.     These postoperative complications could delay postoperative resumption of adequate oral     intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very     limited. Method of Nutritional support (Enteral feeding or total parenteral support)after     pancreaticoduodenectomy is controversial.        1. To evaluate whether early enteral nutrition may be a suitable alternative to total          parenteral nutrition        2. To evaluate whether enteral feeding improve nutritional status after          pancreaticoduodenectomy   "
225861|NCT00809094|"     This Phase IIB proof-of-concept study would examine the effects of an investigational product     called N-acetylcysteine (NAC) on the basic processes that cause inflammation in CF lung     disease. We hope to learn more about the causes of lung disease in cystic fibrosis by     studying the characteristics of the inflammation in the lungs of patients who have CF.   "
225862|NCT00809107|"     The rational of the study is to assess the implantation, pregnancy and live birth rates after     the transfer of frozen- thawed embryos in natural cycles with spontaneous Luteinizing Hormone     (LH)/Progesterone rise or in natural cycles controlled by human chorionic gonadotropin (hCG)     for final oocyte maturation and ovulation.   "
225863|NCT00809120|"     The study was designed to test the following hypothesis      Patients with high cardio-respiratory response to electrostimulation (ES), high perception of     pain during ES and high ES-induced muscle fatigue, have low tolerance to ES (more     difficulties to increase intensity during training).   "
225923|NCT00809913|"     The purpose of this study is to determine whether a 7-day duration of antibiotic treatment of     febrile urinary tract infection (FUTI) is non inferior to 14-day standard duration of     treatment in unselected population presenting at primary care or emergency department.   "
225864|NCT00809133|"     The main purpose of this study is to assess the optimum dose of the following medications     when they are given together:        -  BIBW 2992 and paclitaxel (Taxol)        -  BIBW 2992 and paclitaxel and bevacizumab (Avastin)        -  BIBW 2992 and carboplatin        -  BIBW 2992 and paclitaxel and carboplatin The effect of the different drug combinations          will also be assessed.   "
225865|NCT00809146|"     The goal of this non-inferiority trial is to determine which type of routine care is the best     for paramedics to stop someone from seizing.   "
225866|NCT00809159|"     Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as     treatment of moderate to severe ankylosing spondylitis (AS).   "
225867|NCT00809172|"     The systemic treatments for moderate to severe atopic dermatitis (AD) are limited to     phototherapy and cyclosporine with the risks respectively of either carcinoma, or     hypertension or nephropathy.      Methotrexate was effective in 75% of moderate to severe AD patients with good tolerance in an     open retrospective study.      We want to confirm our observations: a non inferiority multicenter clinical trial,     methotrexate versus cyclosporine, will be conducted in 100 patients for 24 weeks.   "
225868|NCT00809185|"     RATIONALE: RAD001(Everolimus) may stop the growth of cancer cells by blocking some of the     enzymes needed for their growth and by blocking blood flow to the cancer.      PURPOSE: This phase II trial is studying how well RAD001(everolimus) works in treating     patients with myelodysplastic syndromes.   "
225869|NCT00809198|"     The effect of Kynex versus Refresh Plus in subjects with mild to moderate dry eye.   "
225870|NCT00809211|"     RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well nilotinib works in treating patients with     newly diagnosed chronic phase chronic myelogenous leukemia.   "
225871|NCT00809224|"     The purpose of this study is to track areas of the brain, via functional magnetic resonance     imaging (fMRI), that retain structural and functional integrity throughout the lifespan of     people with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.   "
225872|NCT00809237|"     Non-small cell lung cancer (NSCLC) is the most common cause of cancer mortality in men and     women in Singapore.Chemotherapy and biologically targeted agents can extend survival only     modestly for these patients; therefore, discovery of novel ways to prolong the disease course     is a top research priority.      The epidermal growth factor receptor (EGFR) signaling pathway plays a central role in the     neoplastic transformation of NSCLC and promotes cancer cell survival, metastasis, and     angiogenesis. The predominance of EGFR signaling in NSCLC makes the pathway an attractive     candidate for the development of targeted therapeutics. Over the last three years, the FDA     has approved two drugs for salvage treatment of NSCLC, gefitinib (Iressa ®, formerly known as     ZD1839) and erlotinib (Tarceva ®, formerly known as OSI-774). Both are small molecule     orally-bioavailable tyrosine kinase inhibitors (TKIs) of the EGFR TK domain, and have been     shown to improve survival compared to placebo in asian patients when administered after     failure of first or second line chemotherapy for advanced NSCLC.   "
225874|NCT00809263|"     In a homeopathic drug proving a homeopathically prepared substance is administered to healthy     volunteers in order to produce the symptoms specific to that substance and thereby reveal its     inherent curative powers. During a homeopathic drug proving the goal is to provoke temporary     symptoms (or artificial illness) associated with the homeopathic medication. These symptoms     are then arranged to form a symptom pattern or 'remedy picture' which is specific to that     particular homeopathic substance and provides the basis for a better understanding of the     possible effects of that homeopathic remedy in patients.   "
225877|NCT00809302|"     This is a clinical trial to be conducted at multiple Parkinson Study Group (PSG) sites in the     USA. Patients with early Parkinson disease will be randomly allocated to one of 4 arms in the     study. The 4 arms include 3 arms with different doses of aplindore MR tablets and 1 placebo     arm. The study drug will be taken twice a day (BID). The study is blinded and neither     subjects, nor the investigators, will know what treatment the subject is receiving.     Investigational study drug will be adjusted to the assigned dosage and then maintained at     that dosage for the balance of the 12 week follow-up period. The entire study will take about     13 weeks. The study will assess the safety and tolerability of aplindore and measure how     effective aplindore is in improving movement and other effects of Parkinson disease.   "
225878|NCT00809315|"     The purpose of this study is to develop, standardize and provide a preliminary test of a     novel intervention for preadolescent maltreated youth in out-of-home care. It is hypothesized     that the preventive intervention, which is known as Fostering Healthy Futures (FHF) and which     consists of therapeutic skills groups and mentoring, will improve mental health, social,     academic and behavioral functioning and reduce youths' initiation of, and participation in,     problem behaviors.   "
225879|NCT00809328|"     Azithromycin has high rates of clinical response and eradication, wide spectrum of activity,     so we suppose the development of the azithromycin injectable formulation in Japan would     deliver benefit to patients of community acquired pneumonia.   "
225880|NCT00809341|"     This research is being done to see if a PET scan that is obtained after 3 cycles of a     standard chemotherapy regimen can help guide treatment for patients with a blood disease     called Non-Hodgkin's Lymphoma.      The standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the     CHOP combination (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). This regimen     can cure about half of patients with lymphoma, but in many others disease relapses (comes     back). Relapses are generally treated with more chemotherapy.      We believe that a PET scan (a type of imaging study that lights up in areas of cells with     high activity such as lymphoma), may identify patients early who are at high risk of relapse.      The purpose of this research study is to find out if people whose treatment is changed early     to an intensification regimen (high dose chemotherapy) based on a positive PET scan will have     longer remissions than they would if they did not receive that high dose chemotherapy.   "
225881|NCT00809354|"     The purpose of this study is to investigate the long-term analgesic efficacy and safety of     tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing     partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID)     therapy.   "
225924|NCT00809926|"     To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to     valsartan alone in patients with Stage 2 hypertension.   "
225882|NCT00809367|"     The goal of this research study is to determine if it is feasible to collect leukemia cells     from patients ahead of time (before they undergo further treatments) so that these cells     (after being radiated so they will no longer grow or divide) can be given back to them as a     cancer vaccine if/after the participant receives a bone marrow or blood stem cell transplant     in the future. The purpose of the research study will be to collect, freeze and store     leukemia calls from participants blood or bone marrow. This study is a companion study to a     vaccine study.   "
225883|NCT00809380|"     Though much attention has been given to the practice of parental presence during invasive     procedures in children in the ED, few studies have examined the patient's perspective. The     only study to have addressed this issue used a single visual analog scale, which is not a     well validated tool to assess children's distress level. Furthermore, no studies have     assessed parental presence during fracture reduction; only a few incidental cases were     reported in the literature. Finally, most studies evaluating parental presence had     methodological limitations because of the absence of a control group.      The investigators seek to assess whether parental presence during fracture reduction under     sedation, in children 8 to 18 years of age, decreases anxiety levels in both parents and     children.   "
225884|NCT00809393|"     Cardiac surgery with CardioPulmonary Bypass (CPB) exposes to per and postoperative bleeding,     and may lead to allogenic blood transfusion re-intervention and many adverse outcomes.     Prophylactic use of tranexamic Acid (TA) has been shown to decrease blood loss and blood     transfusion during cardiac surgery.There currently are multiple dosing regimens for TA for     cardiac surgery.Preliminary dose-response study has shown that low prophylactic dose of TA     would be as accurate for haemostatic efficacy as higher dose.      The primary objective of this tri-center, prospective, double-blinded, randomised trial is to     compare two administrations and dosing regimens of TA during cardiac surgery with CPB on the     perioperative blood loss.      In addition to the clinical study, a pharmacokinétic/pharmacodynamic study will be conducted.      Patients are divided in two groups: low and high risk surgery. Methods: After written     informed consent, patients are randomly assigned to one of the two treatment groups. The low     dose TA group is: 10 mg/kg TA given over 15 min, followed by an infusion of 1 mg/kg/h     throughout the operation, and 1 mg/kg into the CPB prime volume. The high dose group is :30     mg/kg TA given over 15 min, followed by an infusion of 16 mg/kg/h throughout the operation,     and 2 mg/kg into the CPB prime volume. Hemodynamic and anaesthesia care will be as usual. A     blood salvage device will be systematically used. The triggers for transfusion will be: red     blood cells: haemoglobin less than 8 g/dl or 6 g/dl during CBP; Plasma: PT less than 50% or     INR more than 1.5; platelets: platelets count less than 50/70 G/mm3; fibrinogen: fibrinogen     less than 1g/l . All patients will receive standard anaesthesia and perioperative care.      In 60 consecutive patients in the principal investigator center, 5 blood samples will allow     to assess the plasmatic concentration of tranexamic acid at different time of the surgery     procedure:        1. Baseline        2. 5 min after the loading dose        3. 10 min after the beginning of bypass        4. at the discontinuation of the infusion        5. 1 hour after the discontinuation Plasmatic dosage will be assessed using a high          performance liquid chromatography technique.      Patients will be stratified in two groups for the statistical analysis; low and high risk     surgery. Analysis will be in intention to treat. 300 patients should be recruited in each     group to detect an absolute difference of respectively 10% (low risk cardiac surgery) and 20%     (high risk cardiac surgery) in the number of patients exposed to allogenic blood transfusion     between patients receiving high dose TA regimen and those receiving low dose TA regimen,     assuming a power of 80% and a two-tailed value less than 0.05.   "
225885|NCT00809419|"     The objective of the MERITAGE Trial is to evaluate the safety and efficacy of focal delivery     of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated     with wet age-related macular degeneration (AMD) in patients that require persistent     injections of Anti-VEGF therapy to maintain an adequate response to treatment.   "
225886|NCT00809432|"     Exposure to air pollution is an important risk factor for cardiovascular morbidity and     mortality, and is associated with increased blood pressure, reduced heart rate variability,     endothelial dysfunction and myocardial ischaemia. The study objectives were to assess the     potential cardiovascular benefits of reducing personal particulate air pollution exposure by     wearing a facemask in healthy volunteers.   "
225950|NCT00810277|"     This single arm study will assess the safety and efficacy of tocilizumab in patients with     moderate to severe active rheumatoid arthritis who have an inadequate response to current     non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks     for a total of 6 infusions, either as monotherapy or in combination with their current     non-biologic DMARDs.   "
225887|NCT00809445|"     This is a randomized controlled clinical trial in which adults receiving drug abuse treatment     will be recruited to participate in a multi-center HIV testing and counseling study. The     purpose of this study is to assess the relative effectiveness of three HIV testing strategies     on increasing receipt of test results: (1) on-site HIV rapid testing with brief,     participant-tailored prevention counseling, (2) on-site HIV rapid testing with information     only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness     of the three testing strategies in reducing HIV risk behaviors.   "
225888|NCT00809458|"     The purpose of this study is to find out if vitamin E can help treat prostate cancer. Vitamin     E acts primarily as an anti-oxidant. By decreasing the oxidation in the cancer cell, the     tumor cells may die. Vitamin E is a commonly used vitamin that has not been approved by the     Food and Drug Administration for use in this type of cancer or for any known cancer. This     study will test the hypothesis that vitamin E, in the setting of an oxidative stress such as     smoking, can reduce prostate cancer related biomarkers in patients with localized prostate     cancer in the neoadjuvant setting.   "
225889|NCT00809471|"     This study is being conducted to compare the safety and efficacy of 2 doses of avanafil to     placebo in diabetic men with mild to severe erectile dysfunction.   "
225890|NCT00809484|"     To investigate the management of bone health in postmenopausal women with early breast cancer     (BCA) scheduled to receive anastrozole. Postmenopausal women with hormone receptor-positive     early BCA are assigned to 1 of 3 strata depending on their pre-existing risk of fragility     fracture. Patients (pts) with a bone mineral density (BMD) T-score <-2.0 for either spine or     hip are designated higher-risk (H) for fracture and receive anastrozole 1 mg/day plus     risedronate orally. Moderate-risk (M) pts (T-score <-1.0 for spine or hip but -2.0 at both     sites) are randomized to receive anastrozole plus risedronate (A+R) or anastrozole alone. Pts     with T-scores -1.0 at both spine and hip were designated lower-risk (L) and receive     anastrozole alone. All pts receive calcium and vitamin D. Lumbar spine and total hip BMD are     assessed at baseline, 12, and 24 months.   "
225891|NCT00809497|"     The main objective of this study is to evaluate the effectiveness and safety of the     propionyl-L-carnitine hydrochloride tablets among Chinese population in comparison with the     placebo, for treatment of the peripheral arterial diseases (intermittent claudication) with     oral supplementation of 2g daily for a 4 months continuous administration.   "
225892|NCT00809510|"     The purpose of this study is to evaluate the long-term safety and tolerability of ABT-089 in     adults with mild-to-moderate Alzheimer's disease.   "
225893|NCT00809523|"     This is a randomized, controlled clinical trial of inactivated negative ion generation or     light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression),     for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type,     to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase     and a 4 week treatment phase.   "
225894|NCT00809536|"     1. To estimate the effects of multiple doses of PD 0332334 on the elimination of a single          dose of metformin from the body        2. To estimate the effects of multiple doses of metformin on the elimination of a single          dose of PD 0332334 from the body        3. To evaluate the safety and tolerability when PD 0332334 and metformin are administered          at the same time.   "
225895|NCT00809549|"     1. Circulating bone marrow and blood vessel precursors home in to sites of ischemia and aid          regeneration of injured tissue        2. Increasing the number of circulating precursors will improve in regeneration of damaged          brain following ischemic stroke.   "
225896|NCT00809562|"     This study will evaluate the safety, tolerability and efficacy of RO4917523, in comparison to     placebo, in patients with treatment-resistant depression. Following a washout period from     existing anti-depressant medication, cohorts of patients will be randomized to receive daily     oral RO4917523 at up to five different doses (according to the safety and tolerability     observed at the lower doses during the study), or placebo. The anticipated time on study     treatment is 10 days (in an inpatient unit), and the target sample size is <100 individuals.   "
225897|NCT00809575|"     RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from     patients with myelodysplastic syndromes may help doctors learn more about the disease and may     help plan treatment.      PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly     diagnosed myelodysplastic syndromes.   "
225898|NCT00809588|"     The purpose of this study is to see if the proposed therapy will delay or stop the     progression of the participants skin cancer. This study is being done because there are     currently no treatments which have been shown convincing to treat disease which has     progressed. This research study is designed to evaluate the immunologic effects and clinical     side effects of giving vaccines to patients that are made from their own skin cancer cells.   "
225899|NCT00809601|"     There are different kinds of ear tubes that may be inserted into the tympanic membrane to     relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The     tubes differ in size, shape and material.      No-one knows if there are differences between the different kinds of tubes regarding     complications.      The investigators' hypothesis is that there is differences between the different kinds of     tubes regarding complications.      To test the investigators' hypothesis, the investigators are about to conduct a randomized     controlled study of four kinds of tubes having two different material and two different     shapes.   "
225900|NCT00809614|"     This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis.     The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses     of AIN457 10 mg/kg administered three weeks apart.   "
225901|NCT00809627|"     Caffeine will be studied against placebo in patients with positional headache after a lumbar     puncture (aka spinal headache).   "
225902|NCT00809640|"     The objective is to assess the effectiveness of a prevention campaign promoting active     management in shifting beliefs in 6 to 8 year old schoolchildren. Subjects will be taken from     a random sample of schools in Majorca, Spain: private, public and concerted. A 10 item     questionnaire will be given to all children in that age group, to be answered in class on     days 1, 14 and 97. Schools will be randomly assigned to the study and control groups. In the     study group the students will get a Back Comic-Book (promotes active management) after the     first assessment. The control group will have no other intervention than the questionnaire.   "
225903|NCT00809653|"     Air pollution is a major cause of cardiorespiratory morbidity and mortality. The exact     components of air pollution that underlie the cardiovascular effects are not yet known, but     combustion-derived particulate matter is suspected to be the major cause. Epidemiological     studies have shown that exposure to air pollution causes exacerbation of existing     cardiorespiratory conditions leading to increased hospital admissions and death. The     investigators have recently conducted a series of controlled exposure studies to urban     particulate matter and diesel exhaust in healthy volunteers and patients with coronary heart     disease. The investigators found that controlled exposure to dilute diesel exhaust in     patients with prior myocardial infarction induced asymptomatic myocardial ischaemia with an     increase in electrocardiographic measures of myocardial ischaemia. Whilst important, further     questions remain: (i) does air pollution exposure exacerbate ischaemia and reduce exercise     tolerance in patients with symptomatic angina pectoris, (ii) do real world exposures as     encountered in the urban environment of major cities have similar effects, and (iii) can a     simple face mask intervention to reduce exposure to particulate air pollution improve health     outcomes in patients with coronary heart disease?   "
225904|NCT00809666|"     The aim of the PRAM study was to determine whether women diagnosed with hypertension in     pregnancy, using the traditional mercury device, have the same pregnancy outcomes when blood     pressure is measured by either an automated device or a mercury device throughout the     pregnancy.   "
225905|NCT00809679|"     The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with     postherpetic neuralgia.   "
225906|NCT00809692|"     A critical first step to address the pharmacodynamic information gap in pediatrics resides     with the development of methods capable of accurately measuring the time dependent effects of     xenobiotic exposure in a manner sufficient to enable an integrative analysis of drug action     which incorporates both pharmacokinetic and pharmacogenetic determinants. The proposed study     will evaluate laser Doppler flowimetry, a necessary initial step in developing an ideal     pharmacodynamic surrogate endpoint that ultimately could be used in infants, children and     adolescents to fully characterize the impact of development on the pharmacokinetic (PK) /     pharmacodynamic (PD) / pharmacogenetic (PG) determinants of drug effect for agents capable of     modulating the cellular response to histamine.   "
226236|NCT00807131|"     This randomized clinical trial is a multicentre study conducted at 4 community-based     pharmacies within the Brazilian public health service, which freely distributes standardized     medicines. The group coordinator is located at the Universidade Federal do Rio Grande do Sul,     a public university at Porto Alegre.   "
225907|NCT00809705|"     This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric     emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups     to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4     weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12     weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a     paracetamol test at intervals during the study. The anticipated time on study treatment is 3     months, and the target sample size is <100 individuals.   "
225908|NCT00809718|"     The aim of this study is to study the effect of rifapentine on plasma concentrations of     raltegravir.   "
225909|NCT00809731|"     The objective of this study is to evaluate under routine clinical setting the efficacy and     remission status from treatment of 2nd-generation antipsychotic in patients who is upon acute     episode or not achieving remission under regular treatment from schizophrenia/schizoaffective     disorder. This study will collect in real-life practice the severity of schizophrenia by     Clinical Global Impression (CGI), also evaluate the criteria of schizophrenia remission     applying 8 items of Positive and Negative Syndrome Scale (PANSS) from Andresen working group,     the Montgomery and Asberg Depression Rating Scale (MADRS), and the Global Assessment of     Functioning Scale (GAF). Side effect of movement disorder will be evaluated by Drug Induced     Extrapyramidal Symptoms Scale (DIEPSS). Tolerability for treatment will be monitored by     documenting spontaneous reports on adverse events as well as change in body weight.   "
225910|NCT00809744|"     In this study the investigators want to compare glucose handling (insulin secretion and     insulin sensitivity) in 100 persons with low and 50 persons with normal-high levels of     vitamin D, using a hyperglycemic clamp technique, were sugar is given intravenously for 3     hours in order to keep the blood sugar level at 10 mmol/L. Those with low vitamin D levels     will be randomized to treatment with vitamin D3 (cholecalciferol) 40 000 IU/week or placebo     for 6 months before a new clamp is performed.      The study hypothesis is that persons with low vitamin D levels have impaired glucose handling     which might be improved by vitamin D supplementation.   "
225911|NCT00809757|"     A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI     and Placebo in Subjects Aged Birth to <48 Months with Asthma.   "
225912|NCT00809770|"     The purpose of this study is to determine the effectiveness of a behavioral treatment,     contingency management, in reducing stimulant use in persons with serious mental illness.   "
225913|NCT00809783|"     Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab   "
225914|NCT00809796|"     The purpose of this study is to investigate the safety and possible efficacy of the use of     pentamidine in the treatment of colon cancer metastasis in subjects receiving standard     therapy.   "
225915|NCT00809809|"     Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.   "
225916|NCT00809822|"     Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national     diagnostic criteria. Patients who meet all inclusion criteria and conflict the exclusion     criteria will receive NPB-01(intravenous immunoglobulin) 400mg/kg/day for five consecutive     days or Placebo(physiological saline). Subsequently, efficacy of NPB-01 for therapy of     bullous pemphigoid will evaluate using pemphigoid activity score involving skin lesion area     and Number of new blisters.      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse     events by 57 days after the start of the study treatment.   "
225917|NCT00809835|"     We are testing to see if Galantamine, a learning enhancing medication, will help methadone     maintained cocaine abusers with their learning and memory specific to CBT using an innovative     CBT computer program.   "
225918|NCT00809848|"     The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in     comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each     morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will     be followed for 2 weeks.   "
225919|NCT00809861|"     Aim: Osteosynthesis with locking plate/screws has become increasingly popular in recent     years. It is the only treatment option which allows immediate postoperative immobilization.     However, compared to conservative treatment or treatment with external fixators, locking     plates are very expensive and the operation can be very challenging, even for experienced     surgeons. The long-term results of all treatment modalities are equal, which has been shown     in numerous studies. However, there are no evidence based studies published yet which look at     short-term outcomes. The investigators do feel but do not know that patients who do not need     postoperative immobilization return to work significantly earlier or are independent faster     than patients whose wrists are immobilized for up to 6 weeks. If that is the case, then the     higher costs and risks of the operation are justified, if not, then we have to re-evaluate     our indications for using locking distal radius plates distal radius Methods: Group 1:     Treatment of distal radius fractures with either volar or dorsal locking plates. No fixation     postoperatively, immediate ROM (range of motion) exercises and usage of the wrist in     activities of daily life (ADL) allowed.      Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints     are time to return to work / return to independency (in older people), ROM; Grip strength     (with Jamar Dynamometer).      Outcome scores are DASH (Disability of Arm, Shoulder and Hand Score)and PRWE (Patient related     wrist evaluation).      Group 2 Treatment of distal radius fractures with either an external fixator +/- K-wires or     with K-wires and forearm cast or by cast alone. Main issue is that the wrist is immobilized     for a period of 6 weeks. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks     postoperatively. Endpoints are time to return to work / return to independency (in older     people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH and PRWE. Both     plating and external fixation / cast fixation are standard and accepted treatment modalities     for distal radius fractures. A power analysis indicated that a total sample size of 52     patients randomized equally (1:1) to each treatment arm without any blocking or     stratification would provide 80 % statistical power (alpha = .05, beta = .20) to detect a 20%     difference in mean DASH and PRWE scores.   "
225920|NCT00809874|"     The purpose of this study is to determine the effects of dietary protein on blood lipids and     gut hormones after a fat-rich meal.      Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream     following a fat rich meal. The effect is dependant of both the quality and the quantity of     protein ingested.   "
225921|NCT00809887|"     The study proposes to investigate, in children admitted at Children`s Medical Center at     Dallas, the effectiveness of antimicrobial lock therapy (ALT) with Micafungin in combination     with systemic antifungal therapy in catheter-related fungal infections in order to salvage     highly needed central venous catheter (CVC) and at the same time to investigate the     effectiveness of Micafungin alone as systemic therapy in the treatment of Candidemia in a     pediatric population.   "
225922|NCT00809900|"     This study hypothesis is that anthocyanins from cranberry juice are bioavailable and can be     measured in blood and urine after a single acute consumption of cranberry juice.   "
244509|NCT01055834|"     The purpose of this study is to investigate and evaluate the bioequivalence and food effect     of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.   "
225925|NCT00809939|"     Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous     studies showed that administration of progesterone to pregnant women at high risk, decrease     spontaneous preterm deliveries.      The purpose of this study is to compare between two different modes of treatment with     progesterone for the prevention of preterm delivery: weekly injection of 17 alfa     hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of     efficacy, comfort and compliance, safety and cost of treatments.   "
225926|NCT00809952|"     The purpose of this study is to ascertain whether using ultrasound guidance during     intrauterine insemination (IUI) could increase pregnancy rates.   "
225927|NCT00809965|"     The purpose of this study is to determine whether rivaroxaban in addition to standard care     reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke     in patients with a recent acute coronary syndrome compared with placebo.   "
225928|NCT00809991|"     This will be a Phase II study evaluating the effectiveness and toxicity of a specific     radiation therapy regimen. This choice of daily dose is based on the prior published     experience showing safety and efficacy of hypofractionated regimens. The total dose is     calculated to be effective for late effects which has been shown to be effective and safe in     a large prospective Phase II study. If the hypothesis for the prostate is is true, then this     regimen should be at least as effective or more effective for tumor control than the current     conventional therapy.   "
225929|NCT00810004|"     The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.   "
225930|NCT00810017|"     This study is for women and men who have previously treated metastatic (has spread to other     parts in the body), Her2- positive breast cancer. The purpose of this study is to find out     what effects (good and bad) the FDA-approved drugs etoposide and trastuzumab have on this     type of breast cancer and to determine if these drugs are safe to use together. This research     is being done to find more effective treatment for this type of condition.      In this study, trastuzumab and etoposide will be given by intravenous infusion (IV; through a     vein) on the first 3 days of every 3-week cycle. This is repeated for 6 cycles. After 6     cycles, only trastuzumab will be given until worsening of disease. In this study, a small     amount of your tissue that was collected when you had surgery will be evaluated in the lab to     look at genetic differences among people and how those differences may affect a response to a     specific drug or medicine. This testing will look for a gene called Top2A. Previous studies     suggest that people who have both the Top2A and Her2 genes respond to certain chemotherapies     (anti-cancer drugs) differently from those who only have the Her2 gene.   "
225931|NCT00810030|"     The purpose of this study is to determine how safe, tolerable and effective the new     standardised dosage regimen of FERINJECT® infusions is, compared with a well established     intravenous iron treatment.   "
225932|NCT00810043|"     The objective of this study is to measure the effect that the scraping and scoring of     vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height     restoration and angular deformity correction during a balloon kyphoplasty procedure.   "
225933|NCT00810056|"     This is a multi-county randomized controlled trial of the Fostering Healthy Futures (FHF)     preventive intervention program (consisting of mentoring and skills groups) with 256     maltreated preadolescent youth in out-of-home care. It is hypothesized that participation in     the FHF program will result in better functioning in cognitive, social, and behavioral     domains, and that these gains will result in improved mental health functioning, quality of     life, and reductions in problem behaviors and adverse life-course outcomes.   "
237234|NCT00963105|"     The purpose of this study is to determine the safety and effectiveness of different dose     regimen of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia.   "
225934|NCT00810069|"     This study investigates two different approaches to the change in antidepressant treatment     when an initial treatment is not effective: early intervention or delayed intervention.      Two hypothesis will be tested:        1. that time to confirmed response is shorter in the early intervention strategy vs.          delayed intervention strategy        2. that the time to confirmed remission is shorter in the early intervention strategy          compared to delayed intervention strategy.   "
225935|NCT00810082|"     The purpose of this study is to learn if using the ActiveStep™ treadmill reduces the number     and severity of falls in older adults. This is a pilot study. The information collected will     be used to support a grant application for a large multi-center trial in the future.   "
225936|NCT00810095|"     The primary study objective is to assess the feasibility of using the MindFrame System to     safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients     experiencing an ischemic stroke.   "
225937|NCT00810108|"     The objective of this study is to compare the pharmacokinetics of lopinavir tablets     administered to pediatric patients as either whole or crushed tablets. The study is a     randomized,open-label, crossover study of pediatric subjects already taking     lopinavir/ritonavir tablets as part of their clinical care. THe investigators hypothesize     that lopinavir exposure in pediatric patients will be lower after taking a dose of the tablet     formulation, crushed and mixed with pudding or yogurt, as compared to the exposure after     taking a dose with tablets swallowed whole.   "
225954|NCT00810329|"     The purpose of this study is:        1. To identify specific set of proteins in the cerebrospinal fluid (fluid surrounding the          brain and the spinal cord), that are believed to be seen in Chronic fatigue syndrome          (CFS) patients, but not in healthy controls (HC). A similar study that the investigators          had conducted before,suggested that significant changes in proteins in the cerebrospinal          fluid may be due to the fundamental pathology of this disorder.        2. Increased cerebrospinal fluid pressure (pressure that helps the cerebrospinal fluid to          move around the brain and the spinal cord), may be related with certain symptoms like          headache, sleep problems, light headedness, increased pain, excessive tiredness          (fatigue) even with minimal work and memory problems.        3. Assessment of Autonomic Nervous system function (Sympathetic nervous system)between the          CFS and HC.        4. Perform Lung Function Testing or pulmonary function test to estimate the lung capacities          and score shortness of breath while performing breathing maneuvers.        5. Dolorimetry (18 tender point test) for assessment of pain threshold.        6. Capsaicin skin test        7. Allergy skin test   "
225955|NCT00810342|"     This is a study testing ways to motivate new mothers to become more physically active over a     one year period.   "
225938|NCT00810121|"     Primary objective:      To demonstrate the non-inferiority of Bi-Profenid 100 mg x 2 day versus Bi-Profenid 150 mg x     2 day in patients presenting with pain related to closed, benign, acute post-traumatic     conditions of the motor system or acute, non-infectious rheumatologic conditions, by     comparing, on the one hand, changes in resting pain intensity over the entire day, measured     at the end of the day using a numeric scale (NS), over 5 days and, on the other hand, total     intake over 5 days of concomitant analgesics.      Secondary Objectives:        -  To describe concomitant analgesic treatments        -  To describe the time between baseline and use of a step I, II or III analgesic        -  To evaluate patients pain relief using a Likert 4-class scale (complete or substantial          relief, moderate relief slight relief and absence of relief) at D5        -  To evaluate changes in intensity of pain when moving, over the entire day, measured at          the end of the day using a numeric scale, over 5 days        -  To evaluate the patients overall satisfaction at the end of treatment using a 4-point          Simple Verbal Scale (SVS) (very satisfied, somewhat satisfied, somewhat unsatisfied,          very unsatisfied)        -  To evaluate the patients overall satisfaction at the end of the study using a 4-point          Simple Verbal Scale (EVS) (very satisfied, somewhat satisfied, somewhat unsatisfied,          very unsatisfied)        -  To compare the safety of the two treatments   "
225939|NCT00810134|"     The aim of the study is to compare PTFE-graft bypass surgery versus Viabahn endoprosthesis     for femoropopliteal arterial occlusion in intermittent claudication and critical ischaemia in     patients who would be technically amenable for both treatments. The primary objective is to     compare primary patencies of the two treatments. The secondary objective of the study is to     evaluate secondary patency, functional status, the quality of life and costs of the new     endovascular therapy.   "
225940|NCT00810147|"     The purpose of this study is to determine the safety and tolerability of BMS-708163 in     patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and     the course of any potential effects during a 12-week wash-out period   "
225941|NCT00810160|"     The purpose of this study is to see whether dietary supplements can change the germs in the     intestines of premature infants to be more like those of healthy breast fed term babies.   "
225942|NCT00810173|"     To assay the influence of personality profile to promote behavior change adherence for     physical activity using a pedometer. The investigators also studied the metabolic profile,     diagnosis of depression, intention to change behavior, physical activity referred and the     quality of life. Casuistic and Methods: a randomized quasi-experimental enrolling 48 T2DM     patients using a pedometer for 6 weeks. The intervention group received phone calls     stimulating them to increase their walking activity. The control group received only one     telephone call to explain pedometer use. The investigators also analyzed the personality     profile, quality of life, and metabolic and anthropometric indexes.   "
225943|NCT00810186|"     Background: Patients that suffer from respiratory failure and need mechanical ventilation are     at risk of further deterioration due to complications induced by progression of lung disease     or the mechanical ventilation. The complications usually develop in a progressive manner, but     are currently detected relatively late, when there is already severe and life threatening     deterioration in patient oxygenation and sometimes irreversible damages.      Objective:To measure chest wall dynamics, derived from sensors placed on the chest and     abdomen.      Methods: The system comprises of patches attached to the chest wall and upper abdomen that     include mechanical sensors that measure the mechanics of lung inflation and deflation.   "
225944|NCT00810199|"     This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with     methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients     receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg     intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv     every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment     adjustments (increase or decrease of treatment intensity) may be introduced at intervals,     based on response. The anticipated time on study treatment is up to 3 years, and the target     sample size is approximately 470 patients.   "
225945|NCT00810212|"     The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in     subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral     levels between L1 and S1 and undergoing posterolateral lumbar fusion.   "
225946|NCT00810225|"     Determine if:        -  genetic differences of CNDP1 gene        -  the previously defined GWI/Chronic Fatigue Syndrome (GWI/CFS) cerebrospinal fluid          proteome contents        -  psychometric        -  other variables can differentiate between veterans of the 1990-1991 Persian Gulf War who          have autonomic, neurological and other symptoms and those without these complaints.   "
228561|NCT00847626|"     The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil     combined with chlorthalidone, once daily (QD), in participants with moderate to severe     hypertension.   "
225951|NCT00810290|"     The Lawrence Latino Diabetes Prevention Project (LLDPP) is a community-based translational     research study which aims to reduce the risk of diabetes among Latinos who have a >30%     probability of developing diabetes in the next 7.5 years per a predictive equation. The     project was conducted in Lawrence, Massachusetts; a predominantly Caribbean-origin urban     Latino community. Individuals were identified primarily from a community health center's     patient panel, screened for study eligibility, randomized to either a usual care or a     lifestyle intervention condition, and followed for one year.   "
225952|NCT00810303|"     The purpose of this study is to evaluate the effects of a chronic co-medication of efavirenz     on pharmacokinetics and sterol-lowering effects of ezetimibe at steady-state in healthy     subjects genotyped for ABCB1, ABCC2, CYP2B6 and UGT1A1.   "
225953|NCT00810316|"     To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy     volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release,     and clonazepam tablet.   "
225956|NCT00810355|"     This research studies the effects of Cognitive Behavior Therapy and Cognitive Remediation on     work for persons with schizophrenia. Cognitive Behavior Therapy is a form of counseling that     helps people to improve their mental health by changing the way they think about themselves     and others. Cognitive Remediation is an exercise to improve the thinking process. The purpose     of this study is to determine the extent to which Cognitive Remediation combined with     Cognitive Behavior Therapy helps people who are working.   "
225958|NCT00810381|"     Glaucoma, one of the most common causes of blindness, is associated with increased     intraocular pressure (IOP) and optic nerve head ischemia. Nitrovasodilators are discussed in     the treatment of glaucoma. Nitrates relax smooth muscle cells in the vasculature by     liberating the vasodilator nitric oxide.      The IOP lowering potential and the vasodilator action in retinal and choroidal vessels of     nitrates is still a matter of controversy. Previous studies on the ocular hemodynamic effects     of nitrates showed partially contradicting results. In addition the IOP lowering effect of     nitrates is still unclear. However, recent studies show that long acting nitrates may     preserve optic nerve deterioration and visual field loss.      Therefore, the role of nitrovasodilators in control of ocular blood flow and intraocular     pressure has to be elucidated. For this purpose the investigators plan to test the hypothesis     that nitrovasodilators improve ocular blood supply to the optic nerve head at doses which do     not affect systemic hemodynamics.   "
225959|NCT00810394|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying the side effects and best dose of sorafenib and to     see how well it works in treating patients with advanced malignant solid tumors.   "
225960|NCT00810407|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
225961|NCT00810420|"     The aim of this study is based on recent pilot studies carried out at Odense University     Hospital showing that the acute changes in electroencephalographic (EEG) signals (i.e.     electrical activity inthe brain) elicited by insulin-induced hypoglycemia in patients with     type 1 diabetes can be reliable detected by real-time processing of these EEG signals using     mathematical algorithms and state of the art noise and artifact reduction. These preliminary     results also showed that the hypoglycemia-induced EEG changes are detectable 15-30 min before     deterioration in cognitive function impedes an adequate response to warning. We hypothesize     that these observations apply to the majority of patients with type 1 diabetes, and     therefore, that it is possible to develop an automated device to detect hypoglycemic episodes     by continuous real-time monitoring and processing of EEG signals. To test our hypothesis, the     specific aims of the present proposal are:        1. Detection of hypoglycemia-induced EEG changes using subcutaneous electrodes        2. Ambulatory EEG monitoring using subcutaneous electrodes   "
225962|NCT00810433|"     The purpose of this study is to collect data regarding the safety and feasibility of the     GO-LIF procedure for spinal fixation and stabilization, in conjunction with conventional     approaches for interbody lumbar fusion. This is in order to allow for evidence-based     comparison to pedicle-screw-based techniques as described in the literature.   "
225963|NCT00810446|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
225964|NCT00811655|"     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and     cause less damage to normal tissue. Giving stereotactic radiosurgery before surgery may make     the tumor smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating     patients with brain metastases.   "
225965|NCT00811668|"     In patients with underlying heart diseases like hypertensive heart disease, coronary heart     disease or dilative cardiomyopathy obstructive sleep-apnea, central sleep-apnea and     Cheyne-Stokes-respiration are common finding in polysomnography.      In a lot of these patients it is neither a purely obstructive sleep-apnea syndrome nor a     complete Cheyne-Stokes-respiration but a combination of both sleep related respiratory     disturbances.      Previous studies showed an improvement of the central respiratory disorder, for example     Cheyne-Stokes-respiration, under continuous positive pressure breathing (CPAP) and an     improvement of the left ventricular pump function. (Naughton 1995, Tkacova 1997).      However, the recently published CanPAP study could not prove any improvement in the mortality     among CPAP therapy patients in comparison to the optimal medical treatment, although under     this therapy, the number of breathing disturbances, the oxygen saturation at night and the     ejection fraction of the left ventricle showed a significant improvement.(Bradley 2005)      Earlier studies proved the adaptive servo ventilation to be an effective therapy for patients     with central sleep-apnea and Cheyne-Stokes-respiration respectively. (Teschler 2001)     Teschler's study showed that the adaptive servo ventilation therapy with a reduction of     central sleep apnea down to 10/hours succeeded. With the SOMNOvent CR a new therapy-algorithm     has been developed for the adaptive servo ventilation in patients with obstructive sleep     apnea and Cheyne-Stokes-respiration with underlying heart disease. In the first validation     study this therapy was very effective and presented only few adverse effects in the patients.     (Galetke 2007)      The goal of the study was to compare this new therapeutic option (SOMNOvent CR) with the     established method of continuous positive airway pressure (CPAP) in patients with combination     of obstructive sleep-apnea syndrome and Cheyne-Stokes-respiration with underlying heart     disease.   "
225966|NCT00811681|"     Friedreich's ataxia (FA) is a rare progressive neurological disorder affecting approximately     1/30, 000 individuals. No treatment is presently available to counteract the     neurodegeneration of this extremely severe disease.      Pioglitazone, a well known PPAR gamma (peroxysome proliferators-activated receptor gamma)     ligand induces the expression of many enzymes involved in the mitochondrial metabolism,     including the superoxide dismutases. This agent may be therapeutic by counteracting the     disabled recruitment of antioxidant enzymes in FA patients. This potential neuroprotective     agent crosses the brain blood barrier in human.      Primary objective: To explore the effects of Pioglitazone on neurological function in FA     patients. We expect neurological benefits taking into account the natural course of the     disease.      Population: Subjects for this study will be limited to patients not older than 25 years     Methodology: Prospective, randomized double-blind trial of Pioglitazone versus placebo in FA     patients. Patients will be treated two years and will undergo clinical exams and testing     during three days each six months at the clinical investigation centre.   "
225988|NCT00811967|"     The objective of the study is to evaluate the superiority of treatment with PegIntron and     Rebetol over no antiviral therapy (control group) in subjects with chronic hepatitis C and     type C compensated cirrhosis. Subjects will be randomized in a ratio of 2:1 (Treatment Arm to     Control Arm). Subjects in the Treatment Arm will receive combination therapy with PegIntron     and Rebetol for 48 weeks; then will enter a 24-week post-treatment Follow-up. Subjects who     have detectable Hepatitis C Virus-RNA at Treatment Week 24 will discontinue treatment and     enter Follow-up.   "
225989|NCT00811980|"     We will determine if linezolid inhibits cellular activation and production of     pro-inflammatory cytokines, providing mechanistic rationale for its clinical efficacy and the     justification for further investigations in S. Aureus sepsis.   "
225967|NCT00811694|"     A variety of studies demonstrate that ocular blood flow is altered in glaucoma. Various     animal and human studies have shown an increase in retinal and optic nerve head blood flow in     response to diffuse luminance flicker. Based on studies with ERG, this effect has been     attributed to augmented activity in the retinal ganglion cells and associated axons     indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a     variety of studies have confirmed these effects, the knowledge about this coupling in the     retina of patients with glaucoma is sparse.      Recently the investigators could show that flicker induced vasodilatation is blunted in     patients with open angle glaucoma. However, the investigators results are limited by the fact     that only data about retinal vessel diameters, not blood flow per se, are available. The     further development of the investigators current flicker stimulation technique now allows us     to determine blood flow velocity during flicker stimulation. Thus, in the current study, the     investigators set out to determine whether this blood flow response is impaired in patients     with glaucoma as compared to those in healthy volunteers and whether this is related to     altered neural activity.      The study objective was, to investigate whether the blood flow response to flicker     stimulation is altered in patients with glaucoma.   "
225968|NCT00811707|"     The failure in indwelling epidural catheter for a parturient might cause an anesthetic     difficulty. Furthermore, no one can predict the accuracy of needle placement prior to skin     puncture with any of landmark-based technique. This may result in multiple trying attempts at     needle puncture, pain and discomforts of patients and poor patient satisfaction. The aim of     this study was to explore the difference of epidural space between parturient and     non-pregnant women by assessing ultrasound image.   "
225969|NCT00811720|"     The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in     the treatment of alcohol dependence.   "
225970|NCT00811733|"     Given the tolerability and efficacy of ofatumumab in follicular lymphoma and Chronic     Lymphocytic Leukemia, and the need to improve therapy for patients with WM utilizing a     non-myelosuppressive agent this phase II trial of ofatumumab is being initiated in patients     with Waldenstrom's Macroglobulinemia (WM).   "
225971|NCT00811746|"     This study is being conducted to determine if eszopiclone is as effective as ramelteon when     used as a pre-medication (sleeping pill) in sleep studies performed to diagnose and treat     sleep apnea.   "
225972|NCT00811759|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as temozolomide, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving sorafenib together with     temozolomide may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib     together with temozolomide in treating patients with stage III or stage IV melanoma.   "
225973|NCT00811772|"     Stenosis of the coronary arteries may be treated by balloon dilatation followed by the     implantation of a metal stent. However, restenosis occurs in 10-20% of patients treated with     bare metal stents (BMS). Restenosis and treatment of restenosis is associated with risk of     myocardial infarction (MI) and death. Drug eluting stents (DES)release drugs to the vessel     wall that delay or inhibit the process of restenosis. Some reports have found that DES are     associated with risk of acute stent thrombosis, MI and death. The precise magnitude of this     risk is not known. Current evidence is therefore insufficient to balance the long-term risk     and benefit of BMS vs DES.      The purpose of this trial is to compare the long-term effects on MI and total mortality of     BMS vs DES. The trial will recruit 8000 patients from 8 Norwegian hospitals. The patients     will be randomized to treatment with BMS or DES. Clinical events will be registered for 5     years after treatment. The study hypothesis is that there is no difference in the risk of     death or myocardial infarction after treatment with BMS vs DES. The trial is initiated and     run by university researchers and is sponsored by not-for-profit organizations.   "
226001|NCT00812136|"     Asthma disproportionately affects minorities, but few studies have evaluated interventions to     improve asthma outcomes in minority children.The purpose of the study is to determine whether     Parent Mentors (PMs) are more effective than traditional asthma care in reducing minority     children's asthma morbidity, costs, and use of services, while increasing families' quality     of life and parental self-efficacy.   "
225974|NCT00811785|"     Menkes disease and occipital horn syndrome are two forms of copper deficiency that must be     diagnosed and treated very early in life to prevent serious developmental problems. However,     these and other forms of copper deficiency are not very well understood, and further research     is needed to determine whether certain treatments are useful in treating copper deficiency.     One such treatment is copper histidine, a copper replacement that can be injected directly     into the body to avoid absorption through the gastrointestinal tract. This study will     investigate the effectiveness, side effects, and dosage of copper histidine treatment for     patients with copper deficiency. It will also collect medical history information from     patients to allow researchers to study possible genetic and nongenetic origins of copper     deficiency.      This study will include 100 subjects, all of whom will be children and adults who have been     diagnosed with Menkes disease, occipital horn syndrome, or other unexplained copper     deficiency.      Patients will receive a prescribed dose of copper histidine, which will be administered daily     as an injection.      During the study, patients will be admitted to the NIH Clinical Center on an outpatient basis     to evaluate their response to the copper histidine treatment. These evaluations will take     place every 8 months, with a final evaluation performed after 3 years of treatment. During     the outpatient visits, patients will be required to give blood and urine samples for testing     and undergo ultrasound testing. They will also undergo brain MRI scans at the initial visit     and at the 16-month and 36-month visits. Patients who agree will give additional blood     samples for genetic research purposes.   "
225975|NCT00811798|"     This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus     (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses     of commercially available HPV vaccine before they are 25 years, and were placebo recipients     in the primary study (NCT00306241).   "
226698|NCT00819780|"     The primary objective of this study is to estimate the treatment effect on progression-free     survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6     chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS,     unresectable mCRC.   "
225976|NCT00811811|"     This randomized controlled trial will examine whether behavioral neurocardiac training with     heart rate variability biofeedback (BNT) augments reduction in ambulatory daytime and 24-hour     SBP, DBP and PP, in comparison to an active control intervention (AC, autogenic relaxation     training), among subjects diagnosed with hypertension, and following adjustment for     medications. In addition, the independent association between the BNT and AC interventions on     vagal-heart rate modulation and baroreflex sensitivity will be evaluated during a     standardized assessment protocol of mental stress testing. This study extends a previous     trial conducted at the UHN, in which we reported that the biofeedback intervention     independently augments vagal-heart rate modulation, while reducing symptoms of stress and     depressed mood, among subjects diagnosed with cardiovascular disease. Exploratory features of     this trial will examine the association between ambulatory blood pressure, vagal-heart rate     modulation, baroreflex sensitivity, and markers of inflammatory activity.   "
225977|NCT00811824|"     This study is testing the effects of exercise and dietary change on weight reduction and     biological markers associated with breast cancer risk in breast cancer survivors of Hispanic     or African descent (n=45). This is a randomized, crossover pilot and feasibility study to     test the effects of a 30-minute circuit-based exercise program that combines resistance     training with aerobic exercise in conjunction with a low-fat calorie reduced diet.     Participants will be randomized to either an immediate 6-months of exercise and dietary     change, or a delayed group who will begin their exercise and dietary change program 6-months     after the study begins. Participants in the immediate group will be followed for an     additional 6-months in order to evaluate adherence to the exercise and dietary change     recommendations. Participants in both groups will exercise at a neighborhood Curves® facility     at least 5 times per week for six months and will participate in a series of nutrition     education classes.   "
225978|NCT00811837|"     Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and     leads to deterioration of quality of life. An injury or wound can lead to long term changes     in the nervous system that make the skin more sensitive at and near the injury; this is     termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the     synaptic interaction between neurons.      Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in     animal studies the investigators have discovered previously unrecognized effects of opioids.      UV-B irradaition of the skin of the thigh is an established model of priamary and secondary     hyperalgeisa in humans. The investigators want to test the influence of remifentanil, an     ultra-short acting opioid, on hyperalgesia observed after UV-B irradiation in human     volunteers in a double blind cross-over prospective active placebo controlled clinical trial.   "
225979|NCT00811850|"     A 10 week evaluation, crossover design study including a 3 week washout period between     treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate     0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol     maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.   "
225980|NCT00811863|"     The objective of this study is to prospectively monitor the incidence of adverse drug     reactions, specifically NSF during routine use of gadoversetamide in a large number of     patients with moderate renal insufficiency (eGFR 30-59) and severe renal insufficiency or     end-stage renal disease requiring dialysis (eGFR <30).   "
225981|NCT00811876|"     Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of     treatment   "
225982|NCT00811889|"     This study assesses the effects of bardoxolone methyl (RTA 402) in patients with type 2     diabetes and chronic kidney disease.   "
225983|NCT00811902|"     The primary objective is to assess the activity of nerispirdine in improving the ability to     walk, in patients with multiple sclerosis (MS).      Secondary objectives:        -  To assess other measures of walking ability, tiredness, and lower limb muscular          strength, spasticity, clinical assessment by subject and clinical assessment of change          by the Study Investigator        -  To assess the safety and tolerance of nerispirdine        -  To evaluate the pharmacokinetics (PK) parameters of nerispirdine   "
226020|NCT00812383|"     Single center randomized clinical trial, to evaluate the safety and efficacy of carotid     artery stenting using the RX ACCULINK™ Carotid Stent System with RX ACCUNET™ Embolic     Protection System or PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System     using Angiomax (bivalirudin)versus heparin as the anticoagulant for treatment of occlusive     carotid artery disease in low and high risk patient cohorts.   "
226021|NCT00812396|"     This study will evaluate the ability of comparative proteomics to identify early biomarkers     of muscle anabolism.   "
225984|NCT00811915|"     The use of tacrolimus in the long term as part of the immunosuppressive regimen after     transplantation is associated to complications such as chronic nephrotoxicity, impaired     glucose metabolism (diabetes mellitus) and an increase of the incidence of neoplasia. The     conversion from a tacrolimus based therapy to a sirolimus based therapy associated with     mycophenolate mofetil could improve the incidence of such complications. The aim of this     study is to assess the risk/benefit ratio of this switch performed in stable renal transplant     recipient between 12 months and 36 months after transplantation. The incidence of a composite     endpoint (worsening of GFR evaluated by MDRD formula, incidence of cancer and diabetes) will     be assessed 24 months after conversion.   "
225985|NCT00811928|"     A randomized, open label parallel controlled, multicenter study to evaluate safety and     efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic     patients for prevention of invasive fungal infection   "
225986|NCT00811941|"     The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in     patients with alcohol dependence.   "
225987|NCT00811954|"     The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected     patients who have never received anti-HIV therapy be treated with a triple drug regimen. The     most commonly prescribed and successful regimen contains the medication efavirenz (EFV).     However, this regimen may not be an option for everyone, hence alternative regimens are     needed.      This study was designed to look at how well different combinations of anti-HIV drugs work to     decrease the amount of HIV in the blood (viral load) of and allow immune system recovery in     people who have never received anti-HIV therapy. This study also examined drug tolerability     and safety for the various drug combinations.   "
225990|NCT00811993|"     This study will evaluate the safety and tolerability of R1507 in combination with 12 distinct     standard chemotherapy drug regimens and an additional R1507 monotherapy arm in patients with     advanced malignant neoplasms.The 12 regimens will be tested in parallel. There are 3 subsets     of patients who are eligible for the study: untreated, treated and requiring further     treatment, or treated and failed and for whom adding R1507 represents a suitable treatment     for their disease. All regimens will first test doses of R1507 which are less than the     maximally administered dose, and if tolerated, the dose will be escalated in subsequent     patients. The anticipated time on study treatment is until disease progression, and the     target sample size is 100-500 individuals.   "
225991|NCT00812006|"     This study will provide additional efficacy data for rizatriptan when used for an acute     migraine attack in patients already taking topiramate for migraine prophylaxis.   "
225992|NCT00812019|"     The aim of the present dose ranging study is to evaluate the safety, tolerability and     immunogenicity of two doses of twelve different formulations of a Cell Culture-Derived H5N1     Subunit Influenza Virus Vaccine, adjuvanted with MF59 or non-adjuvanted, given three weeks     apart and followed by a booster dose after 12 months in healthy adults 18 to 40 years of age.   "
225993|NCT00812032|"     The efficacy of low dose aspirin appears to be substantially lower in diabetic patients,     compared to patients without diabetes. The aim of the investigators study is to test the     laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The     investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320     mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve     the response to aspirin.   "
225994|NCT00812045|"     The purpose of this study is to determine the effect of AZD1236 in patients with cystic     fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4     weeks.   "
225995|NCT00812058|"     The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms     of bipolar I depression and to make sure it is safe in humans.   "
225996|NCT00812071|"     Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in     best group. 3 vaccinations in volunteers, at 0 6 and 16 weeks.   "
225997|NCT00812084|"     The purpose of this study is to collect additional data on hospitalized Community-Acquired     Pneumonia (CAP) on health states, health outcomes and on (health) resources and estimate the     differences in the quality of life and resources of elderly persons with and without CAP.   "
225998|NCT00812097|"     The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's     Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction,     or revision. Safety information on the rate of capsular contracture, rupture, and infection     will be collected, and used to help determine device safety.      Approximately 1000 patients at approximately 60 medical centers across the United States were     enrolled in this research study. These patients were implanted with silicone breast     prostheses and will be monitored for 10 years to collect information on risks associated with     the implant surgery as well as changes in the way these patients feel about themselves.   "
225999|NCT00812110|"     We hypothesize that when offered influenza vaccine at little or no cost, in a setting where     the value of the vaccine is connected to one's high risk child, vaccination rates for parents     will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit     environment.   "
226000|NCT00812123|"     The main purpose of this study is to obtain preliminary information on the efficacy, safety     and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF /     steroid therapy, used in the prevention of acute rejection following renal transplantation.   "
226035|NCT00812578|"     The purpose of the study is to examine the effect on metabolic parameters after 12 weeks of     treatment with high dose vitamin D in patients with type 2 diabetes and vitamin D     insufficiency.   "
226002|NCT00812149|"     This study intends to examine how a common genetic pattern affects thyroid function. Recent     studies have demonstrated that a substance (enzyme) produced by a gene has an important role     in controlling circulating thyroid hormone levels. A commonly found pattern in this gene     exists in many individuals and might affect the function of the enzyme. These individuals     need higher doses of thyroid hormone medication in certain situations (e.g. in the treatment     of thyroid cancer after the thyroid gland has been removed) than those individuals without     the variation.      We intend to study this by looking at the response to a hormone-test in healthy volunteers     with different genetic patterns.      We plan to screen healthy volunteers using a blood test to identify their genetic pattern     relating to the enzyme we are interested in. From this group, forty-five healthy volunteers     will be recruited for the hormone-test. This test (called the TRH test) uses a hormone     produced by the brain and stimulates the pituitary and thyroid gland. The response to this     test will allow us to compare the function of the thyroid system in relation to the genetic     pattern of the volunteer.      We hypothesize that the stimulation of the thyroid hormone system will be decreased in     volunteers with a specific genetic pattern and that these individuals will release less     active thyroid hormone from the thyroid gland in response to the TRH test.      This study will provide new information on the effect of a common genetic pattern on thyroid     hormone function and will help us to better understand the way in which the thyroid hormone     system operates. Ultimately, the results of this study might help to provide a more     individualized therapy for patients in need of thyroid hormone replacement.   "
226003|NCT00812162|"     The purpose of this study is to identify how adult men respond to a weight loss diet that     includes pork and eggs and increasing the number of meals consumed throughout the day. This     is a 13-week study (12-weeks of weight loss and 1-week of baseline measurement).   "
226004|NCT00812175|"     In this international non-interventional study safety and clinical data concerning the     treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.   "
226005|NCT00812188|"     Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.   "
226006|NCT00812201|"     This study will collect data on a new feature for future heart failure devices via an     external non-implantable system.   "
226699|NCT00819793|"     The purpose of the study is to evaluate the safety and effectiveness of the CentriMag     ventricular assist system to help patients who have experienced heart failure during surgery     and cannot be removed from cardiac bypass.   "
226007|NCT00812214|"     It is hypothesized that treating insomnia in migraineurs, many of whom also have tension     headaches, prolongs total sleep time to the extent that it decreases overall headache     frequency. Chronic headache sufferers also feel more tired during the day2, undoubtedly     affecting daytime functioning, which is hypothesized to improve as well with prolonged total     sleep time.   "
226008|NCT00812227|"     The purpose of this study is to see whether we can predict which patients with depression     will get better when we treat them with psychodynamic psychotherapy. We will use neuroimaging     (a method of looking at brain activity) in this study. We want to see whether there are     changes in the brains of patients receiving this type of therapy. We hypothesize that these     changes may predict how well certain parts of the psychotherapy treatment process works.   "
226009|NCT00812240|"     The objective of the study is to compare the efficacy and safety of masitinib to imatinib in     patients with gastro-intestinal stromal tumour (GIST) in first line medical treatment.   "
226010|NCT00812253|"     Patients with heart failure often have high blood sugar (glucose).   "
226011|NCT00812266|"     Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a     combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell     type.   "
226012|NCT00812279|"     The overall purpose of this clinical study conducted in confinement under well-defined     conditions is to obtain initial data on the levels of human body exposure to selected smoked     constituents of the SMAR cigarette.      The main objective of this study is to compare the biomarkers of exposure to cigarette smoke     constituents in smokers switching to SMAR and to biomarkers in smokers of conventional     cigarettes (CC). The biomarkers of exposure will be measured in blood and urine samples     collected from the subjects. Moreover, the biomarkers in subjects smoking conventional or     SMAR cigarettes will be compared with those biomarkers in smokers who stop smoking for 5     days. The short term safety of this new product will also be evaluated.   "
226013|NCT00812292|"     The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg     dose of TMC278 is absorbed into the body when administered as a solution, suspension,     granules, or a tablet. In addition, the effect of each formulation of TMC278 will be     evaluated in patients in the fasted and fed states and the palatability (how the drug tastes)     of each formulation will be assessed. Finally, the safety and tolerability of each     formulation of TMC278 will be assessed throughout the study.   "
226014|NCT00812305|"     Review differences between how a healthy person and how a person with liver problems handles     the study drug.   "
226015|NCT00812318|"     To evaluate the single dose relative bioavailability of GSK1265744 10mg administered in     either oral solution fasted, two 5mg tablets fasted, or two 5mg tablets following a moderate     meal.   "
226016|NCT00812331|"     The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of     TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never     received treatment for their hepatitis C infection.   "
226017|NCT00812344|"     This is an explorative study and the scientific question to be investigated is if the biliary     excretion of AZD0837 and its metabolites AR-H069927XX and AR-H067637XX are affected by     co-administration with ketoconazole   "
226018|NCT00812357|"     Descriptive pharmacoepidemiological study on the use of Symbicort Turbuhaler in the treatment     of asthma in France and impact of a new therapeutic strategy on the compliance and control of     asthma   "
226019|NCT00812370|"     Thrombosis is a significant medical complication in children with chronic diseases. The     currently utilized treatments have many drawbacks which can lead to poor outcomes. More     modern therapies are available but have not been systematically tested in children. This     study will determine whether one such medication, bivalirudin is a safer and more effective     alterative.      This study will monitor what effects the drug has upon the child's body and how the body     processes the study drug (absorption, metabolism and elimination). The study will also     evaluate the drug's effectiveness by following how long it takes to dissolve the clot. The     safety issues being monitored relate to any observations of major or minor bleeding episodes     after taking the drug, and/or any other side effects.   "
226022|NCT00812409|"     The purpose of this study is to identify the influence of resistance and aerobic exercise     with different nutritional supplements in middle-aged men and women on various physiological     measures. Throughout the study, the investigators examine body composition, body weight, food     intake, fitness level, metabolism, and blood hormones.   "
226023|NCT00812422|"     The purpose of this study is to compare the safety and efficacy of dexibuprofen syrup and     ibuprofen syrup in patients with fever due to common cold.   "
226024|NCT00812435|"     This is a prospective, open label, randomized trial of 100 patients who present to the     cardiac catheterization laboratory with an ST Elevation Myocardial Infarction for primary     PCI. Patients may receive up-front unfractionated heparin or low molecular weight heparin,     but not glycoprotein IIb/IIIa inhibitors or thrombolytics. Patients will be consented prior     to the diagnostic catheterization and will be randomized once the patient is deemed amenable     to PCI to receive eptifibatide or no eptifibatide just prior to or at the time of primary     angioplasty. Patients will be randomized in a 1:1 fashion. All patients will be assessed for     the primary endpoint of ST resolution at 60 minutes post PCI and followed throughout the     duration of the hospitalization and up to 30 days for secondary endpoint evaluation.   "
226025|NCT00812448|"     The purpose of this study is to evaluate the effects of catechin extracts containing mask on     prevention of influenza infection.   "
226026|NCT00812461|"     The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in     the treatment of alcohol dependence.   "
226042|NCT00812669|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer-killing substances to them. Giving fludarabine     together with cyclophosphamide and rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide     and rituximab to see how well it works in treating patients with chronic lymphocytic     leukemia.   "
226027|NCT00812474|"     Multiple Sclerosis (MS) is a common disease affecting 1/1000 Canadians. Cognition impairment     is reported in 40-65% of patients and is socially and functionally disabling. Although     multiple sclerosis is widely regarded as a white matter disease, cortical disease burden is     increasingly emphasized. Studies confirm that gray matter (GM) disease is grossly     underestimated by conventional MRI. Although the cause for MS is unknown vascular impairment     is implicated in nerve cell death. Several studies have shown perfusion abnormalities in the     central GM and white matter (WM) structure. Severity of perfusion reduction correlates with     lesion load, atrophy, MS subtype and disease duration. Further extent of cortical atrophy     correlates with neurocognitive impairment. We hypothesize that cortical perfusion is a marker     of cortical disease severity and correlates with neurocognitive impairment. To show this we     will measure regional cortical perfusion and regional brain and WM lesion volumes in 26     predefined brain regions using a template developed for Alzheimer's disease. Regional     perfusion will be correlated with neurocognitive tests validated for MS use. Patients will be     divided into impaired and non impaired and perfusion compared controlling for known     confounding factors. If confirmed cortical perfusion may be utilized as a surrogate marker of     cognitive outcome in therapeutic studies.   "
226028|NCT00812487|"     High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe     hospital complications and even death.   "
226029|NCT00812500|"     The purpose of this study was to assess the effect of age on the estimated average     requirement and adequate allowance for dietary protein.   "
226030|NCT00812513|"     Platelet Derived Growth Factor (PDGF) is a potent mitogen for a wide range of cell types     including fibroblasts, smooth muscle and connective tissue. Recombinant human platelet     derived growth factor (R-Pdf/Gbb) has biologic activity similar to endogenous platelet     derived growth factor (PDGF). Biologic activity of PDGF includes encouraging chemotaxis and     proliferation of cells responsible for wound repair and it augments production of granulation     tissue.      The growth factor rhPDGF is found effective in patients having diabetic foot ulcer grade III     and IV. The nature of wounds in the third degree burns is similar so far as healing process     is concerned.      The purpose of this study is to test the hypotheses that the application of R-Pdf/Gbb 0.01%     gel on the third degree thermal and electrical burns will heal these wounds within 3 months     and there will be improvement in general condition of the patients without any complications.   "
226031|NCT00812526|"     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in     perfusion pressure. For a long time it had been assumed that the choroid is a strictly     passive vascular bed, which shows no autoregulation. However, recently several groups have     identified some autoregulatory capacity of the choroid. Choroidal autoregulation was first     shown in a rabbit model where intraocular pressure (IOP) and arterial blood pressure could be     varied independently. In these experiments regulation of choroidal blood flow was not only     dependent on ocular perfusion pressure, but was also dependent on the value of IOP. This     indicates that a myogenic mechanism contributes to choroidal autoregulation, because the     regulatory capacity is dependent on the transmural pressure. In the model of myogenic     autoregulation arterioles change their vascular tone depending on the pressure inside the     vessel and outside the vessel. The present experiments are designed to test whether a     myogenic mechanism may also be involved in choroidal autoregulation in humans. For this     purpose the investigators perform experiments during which the IOP and the arterial blood     pressure is increased. According to the myogenic theory of autoregulation one would expect     stronger vasoconstriction at lower IOPs for the same increase in ocular perfusion pressure.   "
226032|NCT00812539|"     Currently, diabetic patients who receive their care at the diabetes clinic self monitor their     blood glucose using a portable glucometer, under the direction of care providers at the     clinic. We propose to conduct a randomized controlled trial to examine the effect of the     Diabetes Connected Health tool, which is a secure website shared between patients of Type-2     Diabetes and their providers and displays (subjects') blood glucose values in graphical     format. The study will be carried out through multiple primary care practices within the     Partners/PCHI Network. We hypothesize that implementation of the Diabetes Connected Health     Tool will result in overall better Diabetes Care, in terms of improved patient-provider     interaction, and better patient satisfaction towards their care.   "
226033|NCT00812552|"     Multicenter, case-control study, to collect data regarding incidences of late and very late     drug-eluting stent thrombosis with the aim of identifying trends and possible correlates of     stent thrombosis.   "
226034|NCT00812565|"     This study evaluated the effect of 6 or 12 infusions of different doses of octagam     (intravenous immunoglobulin [IVIG]) 10% on the reduction of amyloid beta peptide (Aβ) in     cerebral spinal fluid (CSF) and on the increase of Aβ in blood plasma in patients with mild     to moderate Alzheimer's disease.   "
226037|NCT00812604|"     The purpose of this study is to compare the effectiveness of using topical cream of Ping On     Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and     masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Both     Ping On Ointment and Vaseline are considered intervention.   "
226038|NCT00812617|"     The purpose of the study is to determine the effect of a specific mineral water on serum     lipid concentrations in healthy subjects.   "
226039|NCT00812630|"     This is a two-part trial assessing the effects of MENT on blood pressure. The first part of     the trial is an open-label pilot study to verify the MENT gel formulation delivers     appropriate drug levels. Upon confirming MENT serum levels are within the required range,     clinical trial material will be produced and labeled. Consequently, the second part of the     trial, the main study, will proceed approximately two months after the conclusion of the     pilot study. The main study, is a randomized, double-blind, placebo-controlled study.   "
226040|NCT00812643|"     This is an explorative study and the scientific question to be investigated in this study is     if AZD0837 and/or its metabolites AR-H069927XX and AR-H067637XX and other unknown metabolites     are excreted into the bile.   "
226041|NCT00812656|"     The purpose of this study is to investigate changes in new plasma stroke biomarker panel in     patients undergoing cardiac surgery with the use of cardiopulmonary bypass.   "
226757|NCT00820586|"     A randomized study to assess the safety, feasibility and effectiveness of direct     intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear     cells or selected CD34+ cells in patients with refractory angina pectoris.   "
226043|NCT00812682|"     This study will evaluate the perception of the physicians and the patients about the approved     adjustable dosing of Symbicort® 160/4,5. Symbicort maintenance dose will be adjusted up and     down within the approved dose range of 1x2 - 4x2 inhalations per day, to the level of asthma     symptoms. Patients and physicians perception of this new dosing schedule will be evaluated by     means of questionnaires completion and direct questioning.   "
226044|NCT00812695|"     Obstructive sleep apnea (OSA) is an important cause of refractory hypertension but the impact     of treatment with continuous positive airway pressure (CPAP) is not completely understood.     The aim of this project is to study the effects of CPAP on blood pressure control and its     influences on cardiac remodeling and arterial stiffness in patients with refractory     hypertension and moderate or severe OSA.   "
226045|NCT00812708|"     The purpose of this study is to determine the safety and efficacy of Morcher Iris Diaphragms     in the treatment of congenital and acquired aniridia. Morcher Iris Diaphragms are intraocular     devices designed to provide an artificial pupil for patients suffering from partial or     complete aniridia. These devices are constructed from clinical quality, ultraviolet     light-absorbing, opaque black polymethylmethacrylate (PMMA). After surgical implantation,     patients are monitored over the course of one year to measure any changes to visual acuity     and improvements in light and glare sensitivity.   "
226046|NCT00812721|"     Hypothesis is that tear substitutions cause blur after they are instilled. The investigators     will use aberrometry as a measurement over time after a tear formulation is used and try to     determine if there are any measurable change in higher order aberrations between different     tear formulations and how long it takes to return to pre-instillation measurements thus     providing information on duration of the tear drop. 4 commercially available dry eye     artificial tears formulations will be used and preservative saline will act as a control. The     study will be conducted on subjects that do not have clinical evidence of dry eye syndrome to     focus the data on the blur effects of the tear substitutions.   "
226047|NCT00812734|"     This cohort study aims to know the prevalence at 3 and 6 months after surgery, of persistent     pain, as well as to describe the neuropathic features of this pain. It includes more than     3000 patients scheduled for different types of surgery, some of them already known to induce     persistent pain, some being frequent procedures with no additional data. Clinical and     genetical risk factors will be searched.   "
226048|NCT00812747|"     The purpose of this multicentre prospective trial is to determine the incidence and risk     factors for surgical wound infections. Also the investigators will evaluate consequences of     wound infections to the patients, and extra costs caused by wound infections.   "
226049|NCT00812760|"     It is known that dopamine is a functional neuromodulator at several levels of the visual     system. Dopamine seems to be involved in the organization of the ganglion cell and the     bipolar cell receptive fields and modulation of physiological activity of photoreceptors.     There is evidence for the functional significance of dopaminergic modulation of visual     sensitivity in humans which confirms the hypothesis that dopamine plays an important role in     retinal light adaptation as well as in motion and contrast sensitivity function. The     electrophysiological effects of dopamine, various dopamine antagonist and levodopa in animals     and humans have been investigated by means of visual evoked potentials and     electroretinograms. The multifocal ERG technique, developed by Sutter et al. allows a rapid,     simultaneous recording of focal ERGs from multiple retinal locations. Although this technique     is relatively new, it has already provided insights into the mechanisms of retinal diseases     (e.g. involvement of visual system in Parkinson disease), but until now there is no data on     influence of dopaminergic substances on mERG.   "
226050|NCT00812773|"     This study will evaluate the safety and effect of repeat oral doses of GSK2190915 on lung     function in mild asthmatics using a number of clinical and biological markers of efficacy.   "
226067|NCT00812994|"     Study intended to determine if there are baseline differences in serum neurosteroid levels     and neurotrophic factor (BDNF) levels in healthy controls vs unmedicated depressed subjects,     and whether the levels of these change with antidepressant treatment. Study also intended to     determine if baseline neurosteroid/ BDNF levels, and the change in these levels with     =treatment, are correlated with clinical antidepressant response to escitalopram (Lexapro).   "
226051|NCT00812786|"     The main objective is to develop pharmacokinetic methods for individual dose adjustment of     the global immunosuppressive treatment (cyclosporine, tacrolimus, mycophenolate mofetil and     everolimus, taking into account the pharmacokinetic interactions), in order to optimise the     efficiency and reduce the potentially severe sides effects of these drugs.      Forty five heart-transplant patients are to be included in this phase IV study to obtain a     minimum of 10 patients treated with tacrolimus-mycophenolate, 10 with     cyclosporine-mycophenolate and 20 with everolimus-cyclosporine.      Ten to 11 blood samples will be collected within the 8 to 12 hours post-dose in each patient     and the immunosuppressive drug concentrations will be measured by LC-MS/MS.      The pharmacokinetic models and Bayesian estimators thus developed will provide tools for     individual dose adjustment of immunosuppressive drugs simultaneously, at different     post-transplant periods, using the area under the concentration-time curve (AUC) estimated     using a limited number of time-points (2 or 3).   "
226052|NCT00812799|"     This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass     pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.   "
226053|NCT00812812|"     This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial     dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in     children and adolescents with major depressive disorder (MDD) based on the change from     baseline to Week 8/end-of-study in the CDRS-R total score in a randomized, double-blind,     placebo-controlled parallel-group study.   "
226054|NCT00812825|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics (how the drug effects certain target sites of activity in the body) of     escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will     evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy     volunteers.   "
226626|NCT00818779|"     The investigators aim to assess if a new blood pressure medication, aliskiren, reduces     various biomarkers of heart disease found in the blood in patients with a history of both     heart disease and type 2 diabetes. The primary hypothesis is that aliskiren will reduce these     biomarkers compared to a calcium channel blocker.   "
226055|NCT00812838|"     Peyronie's disease is a condition in which a plaque, or hard lump, forms on the penis. It     causes hardened tissue, pain, and an abnormal bending in the penis. These symptoms are more     severe during an erection. Significant bending of the penis can result in pain, poor     erections, and an inability to engage in sexual intercourse.      This disease affects about 3% of the male population. The average age of onset of this     disease is 57 years old. The cause of the disease is unknown. However, many believe that it     may be due to trauma to the penis (such as injury or extremely vigorous sexual activity).   "
226056|NCT00812851|"     Many patients with ALS experience cramps during the course of the disease. Frequently, cramps     occur as the first symptom of the disease, months before the patients notice weakness and     wasting. Cramp severity varies from mild, without affecting daily activities and sleep, to     disabling, where almost any voluntary muscle activity induces long standing, severely painful     cramping. ALS patients who smoke herbal cannabis (marijuana) or drink hemp tea report     lessening of cramps and fasciculations. Although, various medications, such as magnesium,     quinine sulfate, lioresal, dantrolene, clonazepam, diphenylhydantoin and gabapentin are used     for the treatment of cramps in ALS so far, no medication has been of proven benefit. However,     a recent pilot study with THC in ALS showed symptomatic effects in spasms, fasciculations,     insomnia and appetite. The aim of the proposed study is to determine the tolerability, safety     and efficacy of THC in the treatment of cramps in ALS. The hypothesis is that THC will lessen     cramps in ALS.   "
226057|NCT00812864|"     The aim of the study is to determine blood concentration evolution of capecitabine and its     active metabolites, in elderly patient 75 years and more.   "
226058|NCT00812877|"     The purpose of this study is to determine if MTA or calcium hydroxide are more effective as     pulp capping agents   "
226059|NCT00812890|"     This study will examine the feasibility, practicality, utility and usability of a     semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved     by the food and drug administration (FDA) for both Professional (physician office) and     over-the-counter (consumer) use. The study seeks to:        1. Assess the correlation of this pregnancy test results with serum values (as distinct          from urine) hCG.        2. Assess whether or not time of day of urine collection has any impact on the outcome of          the dBest test.        3. Assess user comprehension of the pregnancy test, especially assessment of the result.   "
226060|NCT00812903|"     The purpose of this study is to determine the prevalence of neck and shoulder pain in Danish     fighter pilots, helicopter pilots and helicopter flight crew and to evaluate the effect of a     24 weeks exercise intervention for fighter pilots.   "
226061|NCT00812916|"     The purpose of this prospective observational study (registry) is to determine the acute     success rate of a complex fractionated atrial electrogram (CFAE) guided ablation procedure     using a dedicated software and to determine the functionality and performance of the CFAE     software in patients with a type of persistent atrial fibrillation (AF) in routine clinical     practice.   "
226062|NCT00812929|"     This study is intended to determine the dose response and duration of action of GSK2190915 in     mild asthmatic adult subjects who experience exercise-induced bronchoconstriction.   "
226063|NCT00812942|"     Adherence rate to screening colonoscopy (TC) in the average-risk general population is still     unclear. Aim of this study was to compare the uptake of TC screening with that of fecal     occult blood (FOBT) in the general population of different Italian areas.   "
226064|NCT00812955|"     The primary purpose of this study is to test the effect and safety of three different doses     of ABT-143 compared to simvastatin in subjects with elevated levels of low density     lipoprotein cholesterol (bad cholesterol) and triglycerides.   "
226065|NCT00812968|"     The purpose of this clinical experience study is to determine whether CC-5013 is safe and     effective (to include studying the process by which a drug is absorbed, distributed,     metabolized, and eliminated by the body [pharmacokinetics]) in Japanese subjects with low- or     intermediate-1-risk MDS (IPSS risk categories) associated with a deletion 5(q31-33)     abnormality and symptomatic anemia.   "
226066|NCT00812981|"     This observer-blind study is designed to show the immunological non-inferiority of     Thiomersal-free-processed pandemic influenza vaccine as compared to the     Thiomersal-containing-processed pandemic influenza vaccine.   "
226068|NCT00813007|"     The goal of this research study is to learn about quality of life, sexual functioning, and     symptoms in women who have undergone abdominal radical trachelectomy for cervical cancer.   "
226070|NCT00813033|"     Parents need understandable information in order to make appropriate choices for their     child's health care. This is especially true when making decisions about invasive medical     procedures. Parents need to understand what will happen, the risks involved, how these risks     will be managed and what other options they have before they can decide what is best for     their child. The present proposal involves the creation of a novel patient decision aid about     the gastro endoscopy procedure, called a scope. The purpose of the aid is to provide     parents with information so they are able to discuss the options with their child's health     care providers.   "
226071|NCT00813046|"     The purpose of this study is to determine whether the oral administration of grass pollen     peptides to treat allergic rhinitis is safe and well tolerated.   "
226072|NCT00813059|"     Non-Arteritic Ischemic Optic Neuropathy (NAION) is a disease producing swelling of the optic     nerve (the cable going from the eye to the brain) resulting in decreased vision. About 15%     of patients will experience NAION in the second eye; many of these patients will be left     legally blind.      Currently, there is no treatment for NAION and for patients in whom the second eye becomes     involved by the disease the outcome can be devastating.      The investigators are conducting a study where the investigators will inject a medication     into the involved eye of patients with NAION. This medication might decrease the swelling of     the optic nerve and improve their vision in that eye.   "
226073|NCT00813072|"     The purpose of this study is to assess objective tumor response in the single agent treatment     of PEP02, irinotecan, or docetaxel for locally advanced or metastatic gastric or     gastroesophageal junction adenocarcinoma   "
226647|NCT00819078|"     Bupropion has been used successfully and safely for smoking cessation in adults. It was also     used in very few studies among adolescent population. Our hypothesis is that Bupropion would     be effective and safe among the adoelscent psychiatric population. A double-blind randomized     controlled-trial will be held to determine that.   "
226074|NCT00813085|"     This study will evaluate whether the use of an electronic diabetes tracker by both patients     and family physicians in Ontario improves diabetes outcomes, satisfaction with care and with     technology and health data privacy issues. As part of the study, the investigators will be     able to test whether practices that use computers perform any better than practices using     paper. The investigators also will be developing the first Canadian computerized chart     summary for each patient that can be communicated securely in emergencies (the Emergency     Health Record) and read by all current electronic systems.   "
226075|NCT00813098|"     The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031     versus a placebo control in subjects with non-constipating irritable bowel syndrome.   "
226076|NCT00813111|"     The purpose of this study is to provide a more effective postoperative method of pain control     for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative     pain management contributes to faster patient mobilization, shortened hospital stays, and     reduced healthcare costs.   "
226077|NCT00813124|"     The goal of this clinical research study is to learn if Vidaza (azacitidine) when given to     patients with CML after an donor stem cell transplant will increase the likelihood of     achieving a complete remission of CML.   "
226078|NCT00813137|"     FOLFOX4 plus Avastin has been suggested as firstline regimen for advanced colorectal cancer     by NCCN, a new angiogenesis inhibitor, known as Endostar(Recombinant Human Endostatin),     prolonged the overall survival, time to progression and improved response rate in metastatic     lung cancer in a large phase III clinical trial in china, so we design this trial to evaluate     the safty and efficacy of FolFox4 plus Endostar in patients with advanced colorectal cancer   "
226079|NCT00813150|"     The purpose of this study is to compare bortezomib, dexamethasone and cyclophosphamide to     bortezomib and dexamethasone alone for primary refractory or relapsed multiple myeloma.   "
226080|NCT00813163|"     The purpose of this study is to see the effect of PEP02 in the treatment of metastatic     pancreatic cancer.   "
226081|NCT00813176|"     The purpose of this study is to determine whether double lumen endotracheal tubes or     bronchial blockers are superior to providing one lung ventilation during thoracic surgery.   "
226082|NCT00813189|"     Children suffering from chronic disease and receiving long-term glucocorticoid therapy suffer     over years from severe growth retardation and profoundly altered body composition. They     consist in a marked increase in fat mass and a decrease in lean body mass. Published studies     have shown that Growth Hormone (GH) treatment in children with Juvenile Idiopathic Arthritis     can improve body composition by increasing lean mass and by preventing increase in fat mass.     The aim of the present protocol is to evaluate whether the increase in lean body mass     observed during GH treatment is associated with changes in muscle strength and mass.      In order to be able to evaluate the effect of GH on the muscle a comparative group is needed.     Therefore it will be proposed to delay in a group of patients the start of Growth Hormone(GH)     treatment by 6 months. As most publications have shown a maximum effect of GH within the     first year of treatment, six months should be enough to evaluate short-term effect of GH on     the muscle. Therefore, this study will be a randomized trial: immediate start of Growth     Hormone (GH) treatment versus start of Growth Hormone treatment 6 months later. After 6     months all children will be treated with GH. Therefore, the follow-up will be one year after     baseline.   "
226083|NCT00813202|"     The present study was an open-label, uncontrolled, and multi-centered phase III clinical     trial for evaluation of the efficacy (clinical efficacy and hemodynamics) and safety of     nesiritide.   "
226093|NCT00813332|"     The purpose of this study is to compare the efficacy and safety of Endostar (Recombinant     Human Endostatin) combined with Docetaxel and single Docetaxel through multi-center,     double-blinding, randomized controlled, phase Ⅳ clinical trial for NSCLC cases who have     obvious progressive disease or intolerant adverse effects in first-line chemotherapy.   "
226094|NCT00813345|"     We previously evidenced in both animal models and patients that a short duration ambulatory     anesthesia impacts the circadian rest-activity biological rhythm, at least during the first 3     days. The light is the main, natural synchronisateur, of the biological cerebral clock, and     is used as therapeutics in chronic disturbances of the circadian rest activity rhythm and of     the sleep (Alzheimer disease for example). We would like to test for a simple and safe     strategy to prevent such a long-lasting effect of anesthesia on biological clock:the increase     of the light intensity at a still physiological level during the initial phase of recovery     from anesthesia by using a particular artificial light of color spectrum similar to natural     sun daylight.   "
226095|NCT00813358|"     The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further     study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment     of thoracic aortic aneurysms.   "
226084|NCT00813215|"     Type 2 diabetes (T2D) is a common disease associated with multiple complications and an     increased risk of cardiovascular morbidity and mortality. Also, it is a heavy economical     burden on society. 1st degree relatives of patients with T2D have an increased risk of     developing T2D. This risk can be modified by the ingested diet: a traditional north European     diet rich in saturated fat increases the risk, while a Mediterranean diet rich in     monounsaturated fat protects from development of T2D and cardiovascular disease.      T2D is a part of the metabolic syndrome consisting of T2D, hypertension, adipositas,     dyslipidemia and steatosis. The pathogenesis of the metabolic syndrome is partly explained by     fasting dyslipidemia, postprandial dysmetabolism (derangement of lipid and carbohydrate     metabolism) and impaired metabolic flexibility. Partly, it can be explained by a chronic     low-grade inflammation in peripheral tissue. The dysmetabolism and the inflammation are     correlating entities exerting their influence through common biochemical pathways. This is     established in patients with T2D, but sparsely studied in healthy relatives of patients with     T2D.      In this project, the investigators will study postprandial dysmetabolism, inflammation,     oxidative stress, adipocytokines, incretins, appetite regulating hormones and the expression     of the genes involved in above mentioned. We will compare healthy 1st degree relatives of     patients with T2D with healthy controls with no family history of T2D and look into     differences in the response to meal stimulation with respectively saturated and     monounsaturated fat. The subjects will be thoroughly examined with a hyperinsulinaemic     euglycaemic clamp and a DEXA scan. Before and after the meal stimulation, we will perform     calorimetry (in order to determine the metabolic rates), take blood samples and perform     muscle and fat tissue biopsies. The biopsies will be used for studies of a vast number of     genes.      The project will give us new valuable knowledge about the interaction between the     intermediate metabolism and the innate immune system and the early pre-diabetic changes in     the 1st degree relatives of patients with T2D. In the long run, the project will contribute     to improving our guidance and treatment of persons at risk of developing T2D.   "
226648|NCT00819091|"     Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have     insufficient glycaemic control despite treatment with a sulfonylurea drug.   "
226085|NCT00813228|"     Patients with diabetes have high blood sugar levels (hyperglycemia) because pancreatic     beta-cells no longer produce sufficient insulin. Insufficient beta-cell function can be     caused by an autoimmune killing of the beta-cells in type 1 diabetes (T1D), or by poorly     understood mechanisms in type 2 diabetes (T2D). Glucagon-like peptide-1 (GLP-1) improves     function of the insulin-producing beta cells, but GLP-1 has a very short circulating     half-life because it is cleaved by the enzyme dipeptidyl peptidase IV (DPP-4). One current     treatment being used to improve glycemia control in patients with T2D is sitagliptin, an     inhibitor of DPP-4. By inhibiting DPP-4, sitagliptin increases GLP-1 levels, resulting in     improved beta cell function. Sitagliptin is now being tested in individuals with new-onset     T1D to determine whether it may help to preserve beta cell function. Because T1D is a disease     in which the immune system destroys the insulin-producing beta cells in the pancreas, we wish     to determine if and how sitagliptin alters immune function. Sitagliptin has been shown by     Merck to be safe and effective with no overt immuno-toxicities. However, several lines of     evidence suggest that DPP-4 inhibitors such as sitagliptin could be immunomodulatory.      This randomized clinical trial will study immune function in healthy volunteers given     short-term (4 week) treatment with either sitagliptin or placebo. During the study, we will     take blood samples at various time intervals before, during and after treatment. We will     compare the immune response with and without sitagliptin treatment using blood samples from     healthy individuals. We will measure changes in the magnitude and type of immune responses.     The study period is nine weeks. The study s primary outcome will be changes in blood plasma     levels of a protein marker associated with decreased inflammation: Transforming Growth Factor     Beta 1 (TGF beta 1). In addition, we plan to use these blood samples to measure sitagliptin s     effect on expression levels of several cytokines (immune proteins). We will also measure the     level of proliferation in stimulated PBMCs (blood immune cells) and gene expression in whole     blood after sitagliptin treatment.   "
226086|NCT00813241|"     A pharmacokinetic study in healthy volunteers to determine the relative bioavailability of     three formulations of celecoxib to the approved formulation.   "
226087|NCT00813254|"     The goal of this research study is to learn about the quality of life and sexual functioning     of women with platinum-resistant ovarian cancer as they receive other treatments for the     disease.      Researchers will study the costs for chemotherapy treatments, other medical expenses, and     treatment-related expenses that are not medical. Researchers will also review any symptoms     these patients may experience related to the cancer or treatment.      In addition, researchers want to learn if and how these patients' caregivers feel the status     of these patients' health may have affected the caregivers' productivity at work and at home.   "
226088|NCT00813267|"     Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing     properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and     complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and     BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine     whether this treatment will result in improvement in osteonecrosis of the femoral head.   "
226089|NCT00813280|"     The major purpose of this Quality Improvement project is to begin to address the issues     surrounding glycemic control in the hospital setting by collecting accurate, reliable and     verifiable data on the occurrence of hyperglycemia (BG >300 mg/dL), and whether or not CIO is     used (immediately before and 72 hours after the BG >300 mg/dl).   "
226090|NCT00813293|"     The purpose of this research study is to determine if sorafenib improves the effectiveness of     a procedure called radiofrequency ablation for the treatment of hepatocellular cancer. During     radiofrequency ablation (RF ablation) a needle is inserted into the tumor tissue and heat is     used to kill the tumor cells.      Sorafenib has been approved by the FDA for the treatment of hepatocellular cancer that cannot     be treated with surgery. Radiofrequency ablation has been used to treat many types of tumors,     including hepatocellular cancers. Pre-clinical data suggests that sorafenib may improve the     efficacy of RFA. The use of sorafenib prior to RF ablation in this study is investigational     and has not been approved by the FDA. Investigational means that this combination is still     being studied and that research doctors are trying to find out more about it. In this study,     the study doctors hope to better understand the extent to which the combination of sorafenib     and RFA may be done practically and successfully. Correlative imaging and tumor studies will     evaluate mechanisms of action as well as novel predictors of RFA efficacy.   "
226091|NCT00813306|"     The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore     the effect of a single dose of AZD2066 on the function of the cardia (the opening between the     stomach and the esophagus) compared to placebo (not containing any medical substance) in     healthy volunteers.   "
226092|NCT00813319|"     African American adolescent females seeking treatment for STIs are an underserved population     at increased risk for HPV infection. While GARDASIL is an effective preventive vaccine,     vaccination rates are low. Given the risk for HPV infection among this subgroup and the     negative health effects associated with HPV, enhancing uptake of GARDASIL is necessary. The     goal of this project is to promote GARDASIL vaccination through the development of a new     multi-component, culturally-appropriate, interactive DVD.      We propose to recruit 280 unmarried African American adolescent females, 13-18 years of age,     from participating clinic sites in Atlanta, Georgia. While seeking clinical services,     adolescents will be contacted and invited to participate in the proposed study. Eligible     adolescents will be required to provide written assent/consent prior to participation.     Adolescents who are eligible and willing to participate in the project will complete a short     survey on a laptop computer. The survey is designed to assess adolescents' risk taking and     preventive behaviors. After they complete the survey, adolescents will be assigned at random     to one of two groups. In one group, adolescents will watch a short (10 min), interactive DVD     designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to     help them remember to return to the clinic for their second and third vaccine doses. In the     second group, adolescents will watch an equally short (10 min) DVD on healthy lifestyles and     behaviors. All adolescents are eligible to receive the GARDASIL vaccine at participating     study clinics as part of their routine standard of care.      With the help of clinic staff, participant medical records will be reviewed over a 7 month     period to assess vaccination rates. Vaccination rates from adolescents who received the     interactive HPV/GARDASIL awareness DVD will be compared to the group of adolescents who     received the healthy lifestyles DVD. It is hypothesized that study participants receiving the     interactive DVD intervention that promotes HPV awareness will have higher vaccination rates     over time.   "
226100|NCT00813423|"     This phase I trial studies the side effects and best dose of sunitinib malate when given     together with hydroxychloroquine in treating patients with advanced solid tumors that have     not responded to chemotherapy. Sunitinib malate may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.     Hydroxychloroquine may help sunitinib malate work better in treating solid tumors. Giving     sunitinib malate together with hydroxychloroquine may kill more tumor cells.   "
226113|NCT00813605|"     This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled,     three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150     eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line     fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be     randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479     plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI   "
226114|NCT00813618|"     To assess the safety of escalating dose levels of MEDI-507 in pediatric stem cell and bone     marrow allograft recipients who have at least Grade II GvHD.   "
226101|NCT00813436|"     Empathy constitutes one prominent ability of social cognition, which represents the human     capability of understanding mental state of the other, and responding in sympathetic way. Two     sets of theoretical mechanisms were designed in order to explain how empathy is possible.     Theory of Mind (ToM)and Simulation.People who suffer from schizophrenia frequently exhibit     social dysfunction, preventing them of a normal integration in healthy human environments.     Recently it had been discovered that impairment in empathy and a specific impairment in     effective TOM are mostly associated with the social malfunctioning of people who suffer from     schizophrenia. One of the biological substances most connected to social cognition is the     neuromodulator Oxytocin. Among its known involvement in uterine contractions and lactating     females, numerous recent studies have found an indispensable role for Oxytocin in various     complex prosocial behaviors such as maternal behavior, attachment, partner preference and     trust. In the proposed study, we plan to examine the influence of a single dose of intranasal     Oxytocin on the two primary mechanisms of empathy, namely mentalizing (Theory of Mind) and     Simulation, both in healthy people and in people who suffer from schizophrenia.   "
226102|NCT00813449|"     Multicenter, double-blinding, randomized controlled, phase II clinical trial on combined     chemotherapy of Endostar (Recombinant Human Endostatin) for untreated patients with advanced     melanoma, To compare the efficacy and safety of Endostar combined with Dacarbazine and     monotherapy of Dacarbazine for advanced melanoma   "
226103|NCT00813475|"     To test whether tight glucose control is associated with better clinical outcome compared to     less-tight control, among diabetic patients hospitalized in internal medicine wards.   "
226104|NCT00813488|"     Evaluate the efficacy of treatment with the fentanyl buccal tablet (FBT) compared with     immediate release oxycodone treatment in alleviating breakthrough pain (BTP) in opioid     tolerant patients with chronic pain.   "
226105|NCT00813501|"     RATIONALE: Studying a diagnostic biomarker test in blood samples from patients who have     undergone a donor stem cell transplant for cancer may help doctors plan treatment.      PURPOSE: This clinical trial is studying an immunologic diagnostic blood test to see how well     it works in predicting side-effects in patients with hematologic cancer or other disorders     who have undergone a donor stem cell transplant.   "
226106|NCT00813514|"     Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic     component. Most importantly a genetic polymorphism in the gene encoding for the complement     factor H (CFH) has been recently identified which is highly associated with an increased risk     of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated     to play a role in the development of the disease.      For this purpose a total of 200 patients with wet AMD will be included in the study. As     described in detail below, the current study aims to identify potentially non-responders to     anti-VEGF therapy based on genetic analysis of VEGF polymorphism and complement factor H     polymorphism.   "
226107|NCT00813527|"     The purpose of this study is to compare changes in cholesterol levels in patients with     elevated blood cholesterol with administration of lapaquistat acetate, once daily (QD), and     fenofibrate.   "
226108|NCT00813540|"     Recent studies have suggested that individuals diagnosed with colon cancer who are inactive     and/or overweight, may have poorer survival outcomes. Exercise training has been shown to     improve fitness and body composition in other cancer survivor groups. The investigators     hypothesize that an exercise training program will be a safe, feasible, and effective     intervention to improve the fitness and body composition of a group of colon cancer     survivors.   "
226109|NCT00813553|"     Carnosine is a natural acid buffering substance of muscle. The primary objective of this     study is to test whether a nutritional supplement of beta-alanine enhances carnosine content     in muscle.   "
226110|NCT00813566|"     The standard treatment approach for patients with high-grade primary brain tumors includes     maximum feasible surgical resection, followed by 6 weeks of concurrent cranial irradiation     and daily low-dose temozolomide chemotherapy, followed by 12 cycles of high-dose temozolomide     administered for 5 consecutive days every 4 weeks [Stupp 2005]. Contrast-enhanced MRI is the     current standard for evaluating the success of therapy and monitoring for tumor recurrence.     MRI is typically obtained prior to initial surgery, within 24 hours after surgery, at the     conclusions of cranial irradiation, and then every 8 weeks during temozolomide chemotherapy     until evidence of recurrence. Despite this careful clinical and radiographic surveillance,     and despite decades of research into the histologic and molecular classification of primary     brain tumors, our ability to predict tumor behavior remains very limited. Some gliomas will     result in overall survival times of only months, whereas other histologically-identical     gliomas may yield survivals of years to decades [Carson 2007, Curran 1993, Lamborn 2004].     Current assessment of tumor response to therapy is also poor. Patients with complete     radiographic response after cranial irradiation often progress rapidly post-irradiation. In     contrast, some patients with enhancing masses at the end of chemoradiotherapy may respond     dramatically to further chemotherapy alone, or the masses may even disappear in the absence     of further therapy (so called tumor pseudoprogression) [Chamberlain 2007]. This confounding     situation demonstrates a need for better assessment of tumor response.   "
226111|NCT00813579|"     This is a prospective assessment of 80 living kidney donors.   "
226112|NCT00813592|"     This is a single-arm, phase II trial of SOM230 in patients with documented recurrent or     progressive intracranial meningioma who have failed conventional therapy and are not     candidates for complete surgical resection of their tumors and/or radiation at the time of     study entry.      At the time of the final analysis, all patients who are receiving treatment with SOM230 will     complete the core phase of the study and will continue on the extension phase. During this     time, additional data on response duration, PFS, and safety will be collected.   "
229179|NCT00852137|"     This Phase II study is designed to evaluate the pharmacokinetics of PEP005 (ingenol mebutate)     Gel, 0.05% when applied in a maximal use setting to the dorsal aspect of the forearm in     patients with actinic keratoses   "
226130|NCT00813826|"     The purpose of this study is to evaluate the efficacy and safety of SLC022 in treating pain     associated with post-herpetic neuralgia (PHN) in recently diagnosed patients.   "
226773|NCT00820794|"     The purpose of this study is to investigate if PD 0332334 affects the pharmacokinetics of     lithium by co-administering both drugs to healthy adults.   "
226115|NCT00813631|"     Background. Malignant fungating wounds(MFW) are caused by cancerous cells invading skin     tissue, which exhibit increased bacterial burdens that not only result in a negative physical     impact (odour, exudates, pain, and infection) on patients, impairing their quality of life,     but they also increase treatment costs. A systematic review of the effectiveness of that the     silver-releasing dressing in the management of infected chronic wounds can help enhance     control of wound bed infection and inflammation, tissue management, moisture balance, and     protect wound edge. However, few studies have examined the effects on people with MFW.      Hypothses In this study that the hypothesized that cancer patients in the ionic silver     dressing group will perception higher quality of life compared to patients in the control     group who receive non-ionic silver dressing. In addition, we hypothesized that cancer     patients who also receive ionic silver dressing will have lower level of symptom distress at     end of study compared to patients in the control group receive non-ionic silver dressing     care.   "
226116|NCT00813644|"     The development of virtual reality (VR) simulators is changing surgical endoscopic education.     The translation of VR skills into clinical endoscopic proficiency has been shown by M.PEARLE.     The improvement in performing endoscopic tasks after VR training was evaluated on a cadaver.     Our goal is to evaluate the performance of novice endoscopists at the operating room by a     randomized controlled study comparing subjects randomized to train on a the UroMentor     simulator to those without VR training.   "
226117|NCT00813657|"     The investigators investigated the effects of a supervised maternal exercise training program     (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health     outcomes in a group of previously sedentary healthy women. A matched control group was     assessed over the same time period. Given the fact that most studies in the field have used     aerobic exercises, here the investigators largely focused on very light resistance, toning     exercises.   "
226118|NCT00813670|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     single and multiple doses of XPF-001 in healthy volunteers.      The effect of food on the pharmacokinetics of XPF-001 will also be studied.   "
226119|NCT00813683|"     We want to study the efficiency of acupuncture for cephalic version of breech presentation     during pregnancy.      Several randomized studies show that acupuncture may be useful in version of breech     presentation, but none with a sham.      Protocol :        -  Inclusion of patients with fetus in breech presentation at 32-34 weeks of pregnancy.        -  Randomization. First group : acupuncture by stimulation of 67 Bladder point.Second          group : stimulation of 45 Stomach point (sham).        -  Ultrasonographic control of presentation at 35 weeks.   "
226120|NCT00813696|"     The purpose of this study is to evaluate the impact of the addition of cisplatin to     gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.   "
226121|NCT00813709|"     REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose     of the study is to obtain long-term follow-up data in subjects with clinically definite     multiple sclerosis (MS) and subjects with a first demyelinating event at high risk of     converting to MS, treated with fetal bovine serum [FBS]-free/human serum albumin [HSA]-free     formulation of interferon [IFN]-beta-1a (RNF).   "
226122|NCT00813722|"     The purpose of this study is to evaluate the importance of providing guidelines to patients     via active telephone calls in blood pressure control and in the discontinuation of treatment     among hypertensive patients. Hypertensives (N = 354) who could receive telephone calls to be     reminded of the dates of their medical appointments and to be instructed about hypertension     were distributed into two groups: a) uncomplicated - hypertensives with no other concurrent     diseases; and b) complicated - severe hypertensives (mean diastolic ≥ 110 mm Hg with or     without medication) or comorbidities. All patients, except those excluded (n=44), were open     block randomized to follow two treatment regimens: traditional or current and to receive     active telephone calls (phone calls group) or not to receive telephone calls (no phone     calls group).   "
226123|NCT00813735|"     Research has established the incidence of insomnia increases with age and the possible causes     contributing to sleep problems in the elderly are still being explored and debated. Older     adults use a disproportionately large share of sleep aids with non-prescription sleep aid use     having increased over the past decade. This study is a double blind safety and effectiveness     trial examining the response of eszopiclone co-administered with escitalopram for the     treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.   "
226124|NCT00813748|"     This study will establish a clinical data and serum repository of anaphylaxis cases     associated with Xolair administration and control patients who have received Xolair without     associated anaphylaxis. This is an observational repository and not an investigational     clinical trial. Associated with the repository is an optional skin testing substudy.   "
226125|NCT00813761|"     The purpose of this study is to compare two marketed contact lens care solutions in regards     to comfort and ocular health.   "
226126|NCT00813774|"     To compare the bioavailability of a single dose of certolizumab pegol solutions given     subcutaneously either by one of the three formulations and to investigate safety and     tolerability.   "
226127|NCT00813787|"     The purpose of this study is to see if a specialized imaging technique using MRI called     multi-exponential T2 component analysis can reliably differentiate between normal brain and     brain tumour.   "
226191|NCT00806507|"     The goal of this clinical research study is to learn whether different ways of viewing     echocardiogram pictures along with blood tests can help to see heart-related side effects of     chemotherapy and trastuzumab earlier than the usual tests.   "
226128|NCT00813800|"     Patients with bipolar disorder have one of the highest rates of nicotine dependence and one     of the lowest quit rates. Varenicline has been shown in previous trials to be effective for     smoking cessation, but has not been studied in subjects with bipolar disorder. This 12-week     open label trial will be conducted to assess the feasibility, acceptability, and safety of     varenicline in bipolar depressed smokers, given in addition to the subject's primary     treatment for bipolar disorder. The primary study hypothesis was that the abstinence rate for     bipolar depressed patients will be 50%.   "
226129|NCT00813813|"     Study to show the effectiveness and safety of a single injection of rhGDF5 into a     degenerating single spinal disc in treating lumbar level degenerative disc disease   "
226131|NCT00813839|"     This study will compare Drager Smart Care (SC), a commercially available automated ventilator     controlled weaning mode to the current daily spontaneous breathing trial (SBT) weaning     protocol. The study is designed to determine if automated ventilator controlled weaning can     reduce total duration of intubation following mechanical ventilation in ICU patients     requiring prolonged mechanical ventilation (>72 hours).   "
226132|NCT00813852|"     The purposes of this study includes (1)to investigate inspiratory muscles and non-inspiratory     muscle function in terms of strength, endurance, and fatigability in patients with     obstructive sleep apnea (OSA), (2) investigate the metabolic characteristics of peripheral     muscles and biochemistry markers in patients with OSA, and (3) to detect the effect of     exercise training on the measured parameters in patients with OSA.   "
226133|NCT00813865|"     This study will measure the long-term safety of AT2101 and its effects on hemoglobin,     platelets, liver and spleen volume, and bone density. This study will also look at the     effects of AT2101 on beta-glucocerebrosidase levels, glucosylceramide levels, and other blood     markers of Gaucher disease.   "
226134|NCT00813878|"     RATIONALE: Diagnostic procedures that measure biomarker levels in nipple section and blood     samples, may help in the early detection of breast cancer.      PURPOSE: This clinical trial is studying nipple secretion samples in detecting breast cancer     in patients and healthy participants undergoing breast cancer screening, breast diagnostic     studies, or treatment for benign breast disease.   "
226135|NCT00813891|"     The purpose of the investigators study is to look at the visual outcomes of Ranibizumab     injections in combination with photodynamic therapy for the treatment of neovascular     age-related macular degeneration.   "
226136|NCT00813904|"     The objective of this study is to assess the immunogenicity and safety of recombinant     Thrombin (rThrombin) in patients with prior rThrombin exposure.   "
226137|NCT00813917|"     Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with     specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable     efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel     mechanism of action of varenicline potentially circumvents the limitations of using nicotine     replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line     of research is to develop effective pharmacologic treatments for ST users to increase     long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that     varenicline is efficacious for the treatment of ST users.   "
226138|NCT00813930|"     Chronic disease management programs are shown to reduce mortality, recurrent     hospitalizations, and improve indirect societal costs among specific subgroups of the     population. INTERxVENT is one such individualized chronic cardiovascular and lifestyle     management program, comprised of several individualized modules - diet, exercise, stress     management, smoking cessation, chronic disease - prescribed algorithmically according to     patient risk profile, environmental surroundings, and behavioural readiness-to-change.     Nonrandomized studies assessing INTERxVENT in diabetic, pre-diabetic, and metabolic syndrome     populations have demonstrated improvement in several intermediary endpoints, including     reductions in fasting glucose, lipids, and blood pressure. However, no randomized controlled     clinical trials in these populations have been conducted. This pilot study is a randomized     clinical trial evaluating the effectiveness of INTERxVENT as compared with 'usual medical     care' in improving cardiovascular risk-factor profiles among individuals with diabetes.     Additionally, the extent to which such findings are generalizable to diabetic, socially     vulnerable, populations is unknown, thus this will be examined also.   "
226139|NCT00813943|"     CORE is a Phase 2 clinical trial in newly diagnosed glioblastoma in subjects with an     unmethylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in     the tumor tissue.      The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling     element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to     appear to be a predictive marker for benefit from temozolomide (TMZ) treatment.      In a safety run-in period in dedicated study centers, the safety and tolerability of     Cilengitide given as an intense treatment in combination with the first part of standard     therapy will be assessed. Thereafter the trial will investigate the overall survival and     progression-free survival in subjects receiving two different regimens of Cilengitide in     combination with standard treatment versus standard treatment alone.   "
226140|NCT00813956|"     This study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin,     and BSI-201 will cause a high percentage of triple negative breast cancer patients to achieve     a pathologic complete response prior to surgery.      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
226141|NCT00813969|"     The study is an investigator-run, open-label Phase 1 safety study of autologous mesenchymal     stem cell transplantation, involving approximately 24 ambulatory participants with relapsing     forms of MS (approximately equal numbers with relapsing-remitting and secondary progressive/     progressive relapsing MS) and evidence of involvement of the anterior afferent visual system.   "
226160|NCT00806104|"     Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the     intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance     of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable     Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of     fructo-oligosaccharides to improve IBS score and to explore which modifications of the     microbiota are responsible of this improvement.   "
226233|NCT00807092|"     This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood     sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to     biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive     subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.   "
226144|NCT00814008|"     Impaired retinal blood flow has been implicated in the pathogenesis of diabetic retinopathy.     Patel et al. (1992) showed that retinal blood flow increases with the level of diabetic     retinopathy. Grunwald et al. (1996) reported that patients with insulin dependent diabetes     mellitus (IDDM) of relatively short duration have increased retinal blood flow, even before     the onset of diabetic retinopathy. On the other hand the data of Bursell et al. (1996)     indicate that IDDM patients have reduced retinal blood flow, when they have normal blood     glucose levels, but this study may have considerable methodological limitations. Acute     elevations of blood glucose levels, however, result in an increase in retinal blood flow     (Grunwald et al. 1987, Bursell et al. 1996). Based on previous experimental data the     investigators hypothesize that ocular blood flow is increased in early diabetes and reduced     at later stages of the disease. Previous studies have demonstrated that metabolic conditions     such as hyperglycemia influence outcome parameters and thereby might have confounded results     regarding ocular blood flow in diabetic retinopathy. The investigators will therefore study     patients with IDDM during euglycemic conditions.   "
226145|NCT00814021|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with     kidney cancer that has spread to the brain.   "
226146|NCT00814034|"     The objective of the study is to monitor the changes of blood coagulation parameters in     postmenopausal patients who are treated with adjuvant Hormonal Therapy for a total of 5     years. The values of the standard coagulation parameters throughout the study will be     compared with the baseline values.   "
226147|NCT00814047|"     Blood flow autoregulation is defined as the ability of a tissue to maintain a relatively     constant flow, despite moderate alterations in perfusion pressure. Similar to the cerebral,     renal, coronary and skeletal muscle circulations, the ocular vascular bed shows the property     of flow autoregulation. This homeostatic mechanism allows blood supply to the eye to match     metabolic demand during daily activities, such as changes in posture, or in more critical     conditions.      Autoregulation has been found to be a complex phenomenon, showing heterogeneity in its site     and time course of action. Since metabolic, myogenic, neurogenic and possibly     endothelium-related mechanisms may be involved, several factors may vary depending on the     challenging stimulus, the vessel tone, or the degree of impairment of autoregulation.      To study the dynamics of ocular autoregulation, it is necessary to introduce a step     disturbance (stimulus) in ocular perfusion pressure and to record the responses of ocular     blood flow continuously before and after this step disturbance. The investigators have     employed a mechanical noninvasive technique to induce an ocular perfusion pressure step     disturbance without drugs or changes in the concentration of vasoactive substances in the     blood by using the thigh cuff technique inducing a small step decrease in ocular perfusion     pressure.      With this technique the investigators could show significant differences in the time response     of blood velocities in the ophthalmic and middle cerebral artery. This clearly indicates     different mechanisms to be responsible for autoregulatory mechanisms distal to the vessels.      Interestingly our results indicate that in the ophthalmic artery a late vasoconstriction     occurs. Many previous investigations have demonstrated that sympathetic nerve stimulation     causes vasoconstriction in the ocular circulation. Accordingly, the present study tests the     hypothesis that α2-adrenoceptors are involved in the dynamic regulation of blood flow in the     ophthalmic and middle cerebral artery after a step decrease in perfusion pressure.   "
226148|NCT00814060|"     This study will examine the bioavailability (the rate and extent to which the active     ingredient or active moiety is absorbed from a drug product and becomes available at the site     of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule     formulation.   "
226149|NCT00814073|"     The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to     placebo in patients with mastocytosis with handicap.   "
226150|NCT00814086|"     This phase I trial is studying the side effects and best dose of cisplatin given together     with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV     ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Drugs     used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     more than one drug (combination chemotherapy) and giving them in different ways may kill more     tumor cells.   "
226151|NCT00814099|"     People with acute respiratory failure usually require the use of an artificial breathing     machine, known as a mechanical ventilator. Sedative medications, which help keep people calm     and reduce anxiety, are often prescribed for children who are on mechanical ventilators.     However, the longer that sedative medications are used, the longer a child may need to remain     on mechanical ventilation. This study will evaluate the effectiveness of a team approach to     sedation management that aims to reduce the number of days that children with acute     respiratory failure require mechanical ventilation.   "
226152|NCT00814112|"     We have previously shown that the plasma level of glycosaminoglycans (GAG) in septic shock     patients are elevated compared to controls. The purpose of this study is to investigate the     temporal dynamic of the blood level of GAG in ten septic shock patients. In addition, to     assess the kinetics of GAG during septic shock we examine the liver function by galactose     elimination capacity as well as excreted urinary GAG.   "
226153|NCT00814125|"     To compare the difference between the ARIMIDEX group and the tamoxifen group in the incidence     of abnormal endometrial histological findings arising after treatment has commenced.   "
226154|NCT00806013|"     The aims of this study were to investigate the effects of CYP2C9 and CYP2C19 polymorphisms on     the pharmacokinetics and pharmacodynamics of glipizide in healthy Chinese subjects.   "
226155|NCT00806026|"     This purpose of this study is to investigate the efficacy and tolerability of pregabalin in     treating idiopathic RLS patients for up to 12 months.   "
226156|NCT00806039|"     The purpose of this study is to determine whether renal team involvement early at the onset     of kidney injury will prevent further developement of more severe renal failure and worse     hospitalization outcomes.   "
226157|NCT00806065|"     The study is designed to assess the safety, tolerability, maximum tolerated dose, and     clinical benefit of treatment with ENMD-2076 administered orally once daily over a range of     doses in patients with relapsed or refractory multiple myeloma.   "
226158|NCT00806078|"     This is an open label randomized single dose two-way crossover study to compare the     bioavailability of a single oral dose of quinine sulfate 648 mg(2 x 324 mg) when mixed with     120 ml of chocolate pudding relative to the same dose given as two intact capsules.   "
226159|NCT00806091|"     The purpose of this study is to obtain young white blood cells (monocytes) from the     investigators donated blood for research into how these cells change into large, mature white     blood cells (macrophages) and how smoking causes Chronic Obstructive Pulmonary Disease     (COPD).   "
226161|NCT00806117|"     Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of     the survival over years. The risk of recurrence after radical surgery has increased with     positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep     invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical     cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy     can improve the overall survival rate of patients with adverse pathological prognostic     factors is inconclusive.      In this study, in order to investigate the effect and adverse reaction of chemotherapy as the     adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine     hundred and ninety patients will be randomly divided into three groups, comparing     radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2     cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The     investigators aim to find out the best therapeutic regimen with lowest adverse reaction for     cervical cancer with adverse pathological prognostic factors. To guide clinical treatment     options.   "
226162|NCT00806130|"     The purpose of this study is to assess health related quality of life and its predictors     among chronic dialysis patients and to assess cognitive function using 3 different tests.   "
226163|NCT00806143|"     Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the     treatment of resistant depression. No accordance exists on which are the involved mechanisms     of action and on which stimulation parameters, frequency and side are optimal.   "
226164|NCT00806156|"     This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients     with metastatic or locally advanced platinum-resistant ovarian cancer.      Approximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102     will be administered at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be     given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. After the     initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional     patients.   "
226165|NCT00806169|"     The aim of this pilot study was to investigate the effects of an intravitreal combination     therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic     retinopathy.   "
226166|NCT00806182|"     The purpose of this study is to determine if cytokines, inflammatory mediators, are increased     in spinal fluid and blood, correlate with disease activity, and could serve as biomarkers or     therapeutic targets in children with opsoclonus-myoclonus syndrome (OMS), an autoimmune     complication of the tumor neuroblastoma.   "
226167|NCT00806195|"     The primary objective of this phase 3b study is to evaluate the safety and tolerability of     Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to     healthy infants   "
226168|NCT00806208|"     A trial to assess safety of four doses of MEDI 507 combined with another drug for initial     treatment of at least Grade II acute Graft-vs-Host Disease in recipients.   "
226169|NCT00806221|"     The purpose of this study is to determine whether early use of a bland emollient in newborns,     prior to the clinical signs of skin disease, will delay the onset or prevent the development     of atopic dermatitis.   "
226170|NCT00806234|"     This study will test the effectiveness of two different treatments for children and     adolescents who have gained weight on their antipsychotic medications.   "
226171|NCT00806247|"     This study was to evaluate the efficacy and safety of dosing regimens of tapentadol HCl     immediate release capsules for the treatment of postoperative pain over a period of 12 hours     on the first day following a bunionectomy in men and women.   "
226172|NCT00806260|"     The purpose of this study is to determine how VI-0521 affect speed and reaction time on     specific tasks that require eye and hand coordination, compared to placebo.   "
226173|NCT00806273|"     Study/Protocol Title: An in vivo comparison of the debridement efficacy of needle irrigation     and ultrasonic root canal irrigation techniques        1. The purpose of this study is to compare the Vista ultrasonic bypass system and          conventional needle irrigation to effectively clean the bottom third of the root canal          during root canal therapy.        2. Participants will be recruited from the general patient pool of the OHSU School of          Dentistry. Patients will have to qualify for the study by meeting the following          criteria: age between 18 and 75 years old, ASA status I or II, are currently planning          treatment for the extraction of teeth, and the patient understands and signs the consent          form. The principal investigator will conduct an interview with the patient and the          student-provider, and obtain informed consent from the patient.        3. The teeth to be extracted will be numbed with local anesthetic. The teeth will be          isolated with a rubber dam and disinfected. The pulp chamber will be accessed using          normal dental equipment and the root canal will be cleaned and shaped using either the          ultrasonic irrigation technique or needle irrigation. This is the first step of standard          root canal therapy. The tooth will then be extracted and the principal investigator will          retain extracted teeth to perform further examination to see how thoroughly the root          canals were cleaned. The teeth will be discarded after study.        4. The investigational device (Vista ultrasonic bypass system) consists of a 30 gauge slot          needle which attaches to an ultrasonic unit (Satalec P5). Irrigants will be delivered to          the apical 1/3 of the root canal through the needle at the same time the needle is being          activated ultrasonically. Irrigant delivery will be controlled by a standard syringe          pump. Conventional needle irrigation will be delivered using a 27guage slot needle          placed into the root canal. Irrigants will be expressed with positive pressure at a          location in the canal short of the needle binding        5. Once the first step of root canal therapy has been completed, the tooth will be          extracted, decalcified, and tissue specimens will be taken from the bottom 3 mm. These          sections will be evaluated under magnification and remaining debris in the root canal          will be quantified using the NIH Image software. The data will be statistically analyzed          to determine and differences between the two irrigation techniques.   "
226174|NCT00806286|"     The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects     with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in     combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the     study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin     and paclitaxel to evaluate effectiveness and safety. The study will find out if adding     CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in     subjects with metastatic non-small cell lung cancer.   "
226175|NCT00806299|"     A 10-day study to determine if grapefruit juice has any effect on how loperamide (Imodium)     affects the body and how the body affects loperamide.   "
237593|NCT00967317|"     To evaluate the efficacy and tolerability of Auris-Sedina in the symptomatic control of     otalgy in patients with and without acute external otitis compared with use of Otosynalar®.   "
226192|NCT00806520|"     Obtain Continuous Glucose Monitoring (CGM) data from individuals taking exenatide LAR,     sitagliptin, or pioglitazone. The CGM measurements collected will help determine the     characteristics of glucose control prior to treatment and during treatment.   "
226193|NCT00806533|"     This observational (non-interventional) post-authorization safety study (PASS) will     investigate the application of Venofundin 6% and of Tetraspan 6% in children with special     regard to drug safety.   "
226176|NCT00806312|"     It is not always known what causes PAH or what the best treatment is. The doctors doing this     study would like to understand more about why some people develop PAH and other do not. They     also would like to learn more about which treatments might help PAH and which people might     respond better to treatments.      Doctors think that testing certain substances found in blood cells might help answer these     questions. These substances are normally released by our bodies to protect us from infection     and to tell the difference between normal and foreign substances in our body. Finally, a new     test will study very small molecules called microRNA that control how our genes are     expressed. This study is being done to see if blood samples can be tested to determine who     might develop PAH, how well drugs will work to treat PAH and to learn more about the     development of PAH.   "
226177|NCT00806325|"     Acute leukemia is a life threatening illness that strikes people of all ages. In addition to     surviving the direct effects of the disease, the treatment of leukemia generally requires     chemotherapy which has its own burden. Infection is one of the most common secondary problems     faced by these patients. Simple infections are common and easily treated with aggressive     antibiotics. However, treated progressive infection leads to loss of vital organ function and     is termed severe sepsis. Severe sepsis is associated with increased risk of death and the     need for specialized care in the intensive care unit.      Besides the appropriate use of antibiotics, little is known about what clinical and patient     factors are associated with the development of severe sepsis. Recent evidence has suggested     that certain practices like frequent transfusion of blood products and control of glucose     levels effects outcome in critically ill patients. In addition, there have been advances in     our knowledge of certain genes that may predispose people to severe infections. It is     possible that these factors are important in people who are not yet critically ill, but are     at risk for the development of severe sepsis.      This observational study will look at genetic, clinical and therapeutic factors that are     associated with the development of severe sepsis. This will help doctors understand what     treatments may be helpful in preventing this serious complication.   "
226178|NCT00806338|"     The purpose of this study is to evaluate the safety and tolerance of multiple intravenous     (through a vein) doses of trodusquemine (MSI-1436) in obese or overweight, type 2 diabetics.   "
226179|NCT00806351|"     The purpose of this study is to gather information on the use of anidulafungin for the     treatment of Candida infection in patients with an abnormal immune system. It is expected     that anidulafungin will be at least as safe and as effective as the comparator drug,     caspofungin.   "
226180|NCT00806364|"     This protocol is designed to provide blood, buccal mucosa and bone marrow aspirate samples     from approximately 250, healthy volunteer donors for use in in vitro studies of mast cells,     mastocytosis, and allergic diseases. Non-atopic donors will be recruited to donate blood,     bone marrow, and/or buccal mucosa samples using conventional techniques. The investigational     nature of the studies in which their blood, bone marrow and buccal mucosa samples will be     used, as well as the risks and benefits of the donation process will be explained to all     donors, and a signed informed consent document will be obtained. Donors will be compensated     according to an established schedule based on the duration and discomfort of the donations.     Samples provided through this protocol will be used solely for in vitro research. Blood, bone     marrow, and buccal mucosa samples will be assigned a unique product number and the study     investigators listed on this protocol will serve as the custodians of the code that links the     product with a donor s identity. The nature of the in vitro studies in which the blood     collected in this study will be used is not the subject of this protocol and will be     described in general terms only. The samples will be used in several Institutional Review     Board (IRB)-approved Laboratory of Allergic Diseases (LAD) protocols. This protocol is     designed to assure adequate and complete informed consent, counseling, and protection of the     study subjects according to IRB, Office of Human Subjects Research (OHSR), Office for Human     Research Protections (OHRP) and other applicable Federal regulatory standards.   "
226181|NCT00806377|"     The purpose of this study is:        -  To document the incidence of electromagnetic oversensing of ICDs during non-thoracic          surgery.        -  To identify any non-thoracic procedure with a higher incidence of generating          electromagnetic oversensing.        -  To document the ability of dual chamber ICDs to discriminate electromagnetic          oversensing.   "
226182|NCT00806390|"     The primary objective of this study is to investigate whether giving prophylactic metoprolol     prior to and during anthracycline or trastuzumab therapy will decrease the incidence of     anthracycline-induced cardiomyopathy. Patients are randomized to receive metoprolol or no     treatment prior to anthracycline or trastuzumab treatment. The ejection fraction, as measured     by nuclear ventriculography is measured before and after treatment.   "
226183|NCT00806403|"     The main objective is to compare a fibrinolytic strategy with an interventional strategy     initiated as early as possible, preferably in the pre-hospital phase, with respect to     resolution of ST-segment elevation at 120 minutes after inclusion and Thrombolysis In     Myocardial Infarction (TIMI) flow grade evaluated at a mandated coronary angiography 5 to 7     days after inclusion.   "
226184|NCT00806416|"     This study will evaluate the bioequivalence of alendronate in combination with vitamin D     (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in     combination with alendronate compared to vitamin D alone.   "
226185|NCT00806429|"     The purpose of this study is to determine the feasibility and safety of transvaginal     appendectomy and determine and compare the postoperative pain and quality of life after     surgery to standard laparoscopic transabdominal appendectomy.   "
226186|NCT00806442|"     The aim of this trial is to determine the efficacy of a combination of two botanicals oils,     borage seed oil and echium seed oil, as a potential treatment for bronchial asthma.   "
226187|NCT00806455|"     Exercise is an important clinical feature in cystic fibrosis. Better exercise capacity has     been associated with better patient outcomes and quality of life. Exercise-induced     bronchospasm is a condition, often associated with asthma, which may make exercise difficult.     The role that exercise-induced bronchospasm has in people with cystic fibrosis is unknown.     This study is designed to determine how often exercise-induced bronchospasm occurs in cystic     fibrosis.   "
226188|NCT00806468|"     This study will be conducted to study the effect of Desmopressin on the nocturnal micturition     frequency in patients with idiopathic Parkinson syndrome.   "
226195|NCT00806559|"     The purpose of this study is to improve the clinical encounter through the design of the     clinical environment. We will conduct a randomized controlled trial to measure the extent to     which a newly designed clinical room, compared to a traditional room, affects the     patient-physician interaction. We will judge this outcome by (a) videotaping encounters; and     (b) conducting post-visit surveys with patients and an interview with physicians. We will use     both qualitative and quantitative tools, including a validated and widely used interaction     coding system on the videotapes, to draw inferences from these data.   "
226196|NCT00806572|"     This is a phase II study to examine the clinical and immunological effects of humanized FcR     non-binding anti-CD3 mAb in participants with Type 1 diabetes mellitus (T1DM), and to develop     this therapy to prevent the immune destruction leading to β cell loss.   "
226197|NCT00806585|"     The study will assess the efficacy and tolerability of MK0736 in patients with Type 2     Diabetes Mellitus and Hypertension who are on ongoing therapy with Angiotensin-Converting     Enzyme or Angiotensin Receptor Blocker. After a 3 to 5 week pre-randomization phase, patients     will be randomized to either MK0736 (3 doses), placebo, or hydrochlorothiazide (HCTZ). The     study will also include a 3 week, posttreatment follow-up period.   "
226198|NCT00806598|"     The goal of this clinical research study is to learn if combining the drugs thymoglobulin,     methylprednisolone, cyclosporine, and G-CSF (NeupogenTM or NeulastaTM ) can help to control     severe aplastic anemia (AA) or hypoplastic myelodysplastic syndrome (MDS). The safety of this     combination therapy will also be studied.   "
226199|NCT00806611|"     Determine if the addition of an intraoperative ethanol celiac plexus neurolysis (alcohol     block) in patients undergoing surgical intervention for pancreatic cancer will result in a     decrease in cancer associated pain   "
226200|NCT00806624|"     This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with     non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient     basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind     DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses.     Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the     Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary     endpoints are incidence of major, clinically relevant non-major and minor bleeding events     (all bleeding).   "
226201|NCT00806637|"     The purpose of this study is to compare vessel sealing system uvulopalatoplasty (VSSU) to the     traditional uvulopalatal flap (UPF) in the treatment of sleep-disordered breathing with     special regard to intraoperative bleeding, operative time, postoperative pain, postoperative     hemorrhage and other adverse effects.   "
226202|NCT00806650|"     This research trial studies the development of a blood test for detecting anti-insulin-like     growth factor II mRNA binding protein 3 (anti-IMP3) antibody and micro ribonucleic acid     (microRNA) in patients with renal cell carcinoma (RCC) that has spread to other parts of the     body (metastatic) or is limited to the tissue or organ where it began (localized). Anti-IMP3     is a tumor marker that can be detected in many human cancers, including RCC and is likely to     be present in the serum (blood) of patients with metastatic or localized RCC. Alterations in     microRNA expression has also shown to play a critical role in cancer progression and may be a     promising biomarker for patients with RCC. Developing a blood test for anti-IMP3 antibody and     microRNA in serum and tissue samples of patients in the laboratory may help doctors find and     diagnose RCC earlier, find out how far the disease has spread, and plan effective treatment     for RCC.   "
226203|NCT00806663|"     This is an open label single arm prospective multicenter Phase II study in around 20     patients. The primary objective of this study is to evaluate whether the addition of     sunitinib to FOLFIRI results in a significant reduction of tumor vessel permeability (TVP)     and blood flow (BF) measured by DCE-MRI and DCE-USI, measured on liver metastases.      Secondary objectives are antitumor response, time to progression (TTP), effect on     pharmacokinetics of sunitinib and biomarkers (VEGF und soluble VEGF-receptor) and     drug/treatment safety.   "
226204|NCT00806676|"     People with chronic kidney disease are known to have immune response abnormalities, including     a diminished response to some vaccinations. Those with chronic kidney disease have a     disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to     immune response abnormalities, the CKD population may or may not respond to the recommended     three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and     18-related genital tract disease. The objective of this study is to measure the antibody     response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD)     (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant.     Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples     to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained     at months 0, 7 and 24.   "
226219|NCT00806897|"     This study is conducted in Europe. The aim of this observational study is to gain practical     experience with once daily Levemir® administration in type 2 diabetes patients who were     previously treated with NPH insulins (e.g. Protaphane®) as basal insulin as part of their IIT     under normal clinical practice conditions in Lithuania   "
226232|NCT00807079|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when     given together with carboplatin and to see how well they work in treating patients with     relapsed or metastatic cervical cancer.   "
226234|NCT00807105|"     This is a prospective open label study of acute and maintenance treatment of MDD. The acute     phase consists of daily treatments for 4 weeks. maintenance will be twice a week for eight     weeks followed by 10 weeks of once a week treatments.   "
226235|NCT00807118|"     Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial     formulation in both under fasted and fed condition, and bioequivalence between formulation     E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective     is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set     to get data for Japanese regulatory submission.   "
226205|NCT00806689|"     24 hour Holter monitoring (24HM) is commonly used to assess cardiac rhythm after surgical     therapy of atrial fibrillation. This snapshot rhythm documentation leaves a large     diagnostic window of non recorded atrial arrhythmias and as such a large amount of     uncertainty in follow-up result assessment. To improve accuracy of rhythm surveillance thus     gaining a more real-life scenario of post surgical ablation therapy cardiac rhythm a new     insertable cardiac rhythm monitor device (Reveal® XT 9525, Medtronic Inc., Minneapolis, MN,     USA) with full observational continuous heart rhythm documentation is implanted.      In order to verify different follow-up strategies after surgical atrial fibrillation therapy,     a comparison of different follow-up scenarios (symptoms, different cardiac documentation     devices i.e. ECG and 24 hour Holter monitor, at different follow-up time points) is performed     intraindividually. Thus the reliability of these devices and follow-up strategies to define     success after ablation therapy is evaluated.   "
226206|NCT00806715|"     The goal of this study is to examine the impact of iron overload in patients undergoing a     bone marrow transplant. We believe that the iron status in these patients is associated with     complications for transplant survivors. We will examine the iron status in these patients by     MRI and by screening for mutations in genes known to cause iron overload. We will also     determine the levels of hepcidin (a hormone produced in the liver that appears to regulate     iron homeostasis) from blood and urine.   "
226207|NCT00806728|"     A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell     and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.   "
226208|NCT00806741|"     Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance     to changes in perfusion pressure. In the eye, several studies have reported that retinal     blood flow is autoregulated over a wide range of ocular perfusion pressures. The     investigators recently showed that nitric oxide (NO) is a key metabolite in the regulation of     vascular tone in the eye and plays an important role in the blood flow autoregulation of the     choroidal circulation. However, no data is yet available for the optic nerve head. Thus, the     present study is designed to test the hypothesis that NO plays also a role in optic nerve     head blood flow autoregulation. Therefore, subjects will perform squatting to increase     systemic perfusion pressure during administration of either a nitric oxide synthase inhibitor     (L-NMMA), an α-receptor agonist (phenylephrine) or placebo. Optic nerve head blood flow will     be continuously measured during the procedure to investigate optic nerve head autoregulation.   "
226209|NCT00806754|"     -  The primary objective of this study is to evaluate the efficacy of the concomitant          administration of ciclesonide nasal spray and azelastine nasal spray versus ciclesonide          nasal spray alone in patients (18 years or older) with perennial allergic rhinitis (PAR)          not adequately controlled on an intranasal corticosteroid or antihistamine monotherapy        -  The secondary objective is to investigate the safety of the concomitant administration          of ciclesonide nasal spray and azelastine nasal spray   "
226210|NCT00806767|"     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem     cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It     also stops the patient's immune system from rejecting the donor's stem cells. The donated     stem cells may replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune     response against the body's normal cells. Giving antilymphocyte globulin before transplant     may stop this from happening.      PURPOSE: This phase II trial is studying how well fludarabine, busulfan, and antilymphocyte     globulin together with donor stem cell transplant works in treating older patients with     hematological cancer.   "
226211|NCT00806780|"     The purpose of this study is to assess whether routine imaging of the biliary system during     routine gallbladder surgery alters clinical outcome   "
226212|NCT00806806|"     Given as a single perioperative injection, SKY0402 could provide adequate, continuous, and     extended pain relief that could greatly simplify postoperative pain management, reduce the     need for repeated administration, and minimize episodes of breakthrough pain.   "
226213|NCT00806819|"     The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed     therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in     patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed     will be obtained.   "
226214|NCT00806832|"     Cataract surgery is the most prevalent surgical procedure. Since most candidates are elderly     patients, hypertension is common among these patients. Preoperative anxiety and tension may     cause elevation of patient's heart rate and blood pressure and thus expose them to serious     potential complications such as stroke and myocardial infarction. Medical clowns are known to     reduce preoperative anxiety of both children and their parents. It is possible therefore that     medical clown may have such a beneficial effect also on patients scheduled for cataract     surgery under local anesthesia.   "
226215|NCT00806845|"     The aim of this study is the assessment B-cell immune responses in HIV-infected individuals.   "
226216|NCT00806858|"     This study is conducted in Asia. The aim of this observational study is to evaluate subjects'     treatment satisfaction and to evaluate subjects' preference of pen device and the incidence     of clinical technical complains while using NovoPen® 4 under normal clinical practice     conditions.   "
226217|NCT00806871|"     The aim of this study is to assess the efficacy of injecting steroid into the carpal tunnel     in relieving symptoms of carpal tunnel syndrome for at least 1 year with outcomes measured     with patient evaluated symptoms score.Out of the patients referred by primary care, those     with a clinical diagnosis of CTS who have tried wrist splint and whose symptom severity is     judged by the examining surgeon to warrant surgery are offered to be put on the waiting list     for carpal tunnel release. This means a waiting time of approximately 3 months. Patients who     give informed consent will be asked to attend the outpatient clinic for a physical     examination followed by allocation to one of the three trial groups. Immediately following     the allocation the patients will receive the assigned treatment.   "
226218|NCT00806884|"     Hypothesis: The addition of a series of musculoskeletal techniques to normal optimal care for     the treatment of a respiratory exacerbation in inpatient adults with cystic fibrosis, will     lead to further improvements in pain, posture, sputum clearance, lung function and quality of     life.   "
226220|NCT00806910|"     Heart Failure is a growing and challenging public health concern in the United States. Heart     failure commonly manifests as a syndrome of salt and water retention. Arginine vasopressin is     a peptide hormone that is intimately involved in salt and water homeostasis. AVP is released     into the circulation in response low blood volume and hypernatraemia. Despite fluid overload,     vasopressin levels are often inappropriately elevated in patients with heart failure and LV     dysfunction. Data suggest that vasopressin may also contribute to the deleterious circulatory     response in patients with heart failure and play a role in the development and progression of     the disease process. In their study, Udelson et al. showed that vasopressin receptor     antagonism with Conivaptan resulted in significant diuresis with stable hemodynamics in     advanced heart failure patients. Currently Intravenous diuretics and vasodilators are the     standard of care in treating patients with acute decompensated heart failure. We will be     studying the renal and diuretic effects of add on therapy with intravenous Conivaptan in     patients receiving intravenous Nesiritide and intravenous diuretics.   "
226221|NCT00806923|"     This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a     standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous     non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated     time of study treatment is until disease progression, and the target sample size is 500+     individuals.   "
226222|NCT00806936|"     This study is conducted in Asia. The aim of this observational study is to investigate the     percentage of patients reaching the treatment target on blood glucose control after treatment     with either human insulin or insulin analogues in type 2 diabetes subjects inadequately     controlled with two or more oral antidiabetic drugs in China. Further the safety profiles     will be evaluated.   "
226223|NCT00806962|"     Randomized, double blind, multi-site, study in healthy adults, comparing safety and     immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with     placebo controls      Primary Objective:        -  Safety as determined by occurrence of local intranasal symptoms or other symptoms as          reported by a self-administered memory aid for 7 days after each vaccination and          hematology, blood chemistry and physical examinations performed by the clinical research          staff        -  Subjects will also be monitored for Serious Adverse Events (SAEs), and onset of any new          medical conditions for 180 days following the last study vaccinations (Day 201).      Secondary Objectives      Evaluations of immunogenicity as determined by:        -  Geometric mean titers and seroconversion rate of serum anti- Norwalk VLP IgG and IgA        -  Stimulation of anti-Norwalk VLP IgA antibody secreting cells (ASC)        -  Presence of antigen specific memory B-cell response      Cells will be collected and stored for possible future evaluation of Norwalk VLP-specific     cell-mediated immune (CMI) responses      Study Hypothesis:      The incidence of adverse events after intranasal Norwalk VLP Vaccine will be the same as the     incidence of adverse events after intranasal adjuvant/excipients alone. Norwalk VLP Vaccine     and adjuvant/excipients will have a higher incidence of mild to moderate nasal adverse events     compared to placebo but similar incidence of other adverse events.      Two doses of the 100 µg of Norwalk VLP Vaccine will be more immunogenic than two doses of 50     µg of Norwalk VLP Vaccine. The post-vaccination serum antibody responses, the number of     antibody secreting cells (ASC) and IgG and IgA memory B-cell responses directed against     Norwalk Virus antigen will be increased after Norwalk VLP Vaccine compared to     adjuvant/excipients and to placebo.   "
226224|NCT00806975|"     The purpose of this study is to investigate patient's usability, preference and blood glucose     control for the new prefilled disposable insulin lispro mixture (Humalog Mix 25 injection     KwikPen®). For that purpose, randomized open-label, 2-period direct comparative crossover     study is planned in comparison with insulin aspart mixture (Novo Rapid 30 Mix injection     FlexPen®).   "
226225|NCT00806988|"     Coronary artery bypass grafting (CABG) is a procedure that people with coronary artery     disease (CAD) may undergo to increase blood flow to the heart. During a CABG procedure,     people who have a leak in one of the valves in the heart—the mitral valve—may at the same     time undergo a procedure that repairs the valve. This study will evaluate whether people with     moderate mitral valve leakage would be better off undergoing CABG plus the mitral valve     repair procedure or undergoing CABG alone.   "
226226|NCT00807001|"     This is a proof-of-concept study which will provide data about the safety and antiviral     activity of several doses of the investigational drug IDX184 given for 3 days in     treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for     testing in later studies.   "
226227|NCT00807014|"     The objectives of this clinical trial are to compare the quality of life of the subjects, the     efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin     phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), applied once daily,     against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to     moderate acne vulgaris.   "
226228|NCT00807027|"     This clinical study was planned in order to assess the superiority of INNOCELL Corp.     Immuncell-LC in aspects of therapeutic efficacy and safety when administered with     Temozolomide to glioblastoma patients when compared with the control group who did not     receive administration of the drug.   "
226229|NCT00807040|"     People with coronary artery disease (CAD) or people who have had a heart attack may develop a     leak in the mitral valve of their heart and may therefore need to undergo surgery to fix the     valve. The best way to fix the mitral valve remains undetermined. This study will evaluate     whether it is better for people with severe mitral valve leakage to undergo a mitral valve     replacement procedure or a mitral valve repair procedure.   "
226230|NCT00807053|"     The primary objective of this study is to demonstrate the efficacy of ciclesonide HFA,     applied as a nasal aerosol once daily, in patients with SAR. The secondary objectives are to     evaluate Quality-of-Life and safety.   "
226231|NCT00807066|"     Patients with locally advanced (IIIB with effusion) or metastatic non-small cell lung cancer     (NSCLC), EGFR FISH positive, candidate for a first-line platinum-based chemotherapy will be     considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and     after signature of informed consent form, all eligible patients will be randomized to receive     standard chemotherapy (control arm) or gefitinib (250 mg daily dose-experimental arm).     Before, and in every case, no more than 4 weeks before study entry, all eligible patients     will receive a complete disease staging, including thoracic and abdominal CT-scan, and blood     sampling. Bronchoscopy will be done if not previously performed. Bone scan and brain CT-scan     will be performed only if clinically indicated. Disease assessment will be performed every 6     weeks (every 2 cycles) for the first 6 cycles, and thereafter every 3 months, with a     confirmatory evaluation in all patients with response or disease stabilization no less than 4     weeks after the response assessment, according to RECIST Criteria. A complete disease     staging, including the above mentioned procedures, will be performed in case of progressive     disease, and, in every cases, when patient withdrawals the trial. Following completion of     protocol therapy, patients will be followed every 3 months.   "
226237|NCT00807144|"     The current anti−rejection drug regime for kidney transplant recipients in use at the West     London Renal & Transplant Centre (WLRaTC) consists of induction therapy with the very potent     monoclonal antibody Campath 1−H (Alemtuzumab) followed by long−term maintenance with the     Calcineurin inhibitor Tacrolimus      The recent development (and licensing in the UK) of an extended−release, once daily     formulation of Tacrolimus holds out the promise of simpler drug regimes for our patients. In     the context of our current successful use of Tacrolimus monotherapy maintenance after Campath     1−H induction, the extended−release Tacrolimus formulation will enable us to offer a regime     where the only long−term immunosuppressive treatment that most of our patients need will be a     single drug, taken once a day.      The investigators wish to assess the efficacy of such a regime in a structured comparison     with our current protocol.   "
226238|NCT00807157|"     The purpose of the the study is to determine if PROBIOSTICK® decrease stress and anxiety of     people sensible to daily stress.   "
226239|NCT00807170|"     A clinical study to investigate the maximum tolerated dose of Vandetanib and concurrent WBRT     in patients with NSCLC and brain metastases. All patients will receive WBRT, 10 fractions of     3 Gy. Patients will start 7 days prior to start of radiation treatment with Vandetanib. Total     treatment time with Vandetanib is 3 weeks (21 days). Patients will have the opportunity to     continue Vandetanib until progression at a dose of 300 mg. This multi-centre study will be     conducted in a minimum of 9 patients and a maximum of 18 patients at 3 sites.   "
226240|NCT00807183|"     Although particulate matter (PM) exposures have been linked with poor respiratory health     outcomes, most of these studies have focused on airsheds with urban and industrial sources of     PM2.5. Woodsmoke-derived PM also contributes to ambient PM in these urban areas, and is the     major source of PM in many US rural or peri-urban areas, as well as in many communities     within developing countries. This study will focus on indoor air quality and clinically     relevant changes in health effects among asthmatics living in homes whose primary heating     sources are non EPA-certified woodstoves. The Primary Aim of this study is to assess the     efficacy of residential interventions to reduce indoor PM exposure from woodstoves and the     corresponding improvements in quality of life and health outcomes for asthmatic children. The     study area for this project will be three rural communities in western Montana and Idaho,     including one Indian Reservation. This study will use a three arm (Tx1, Tx2, and Tx3)     randomized placebo-controlled intervention trial. The interventions will be at the household     level, and exposure and outcomes will be assessed for one asthmatic child in each household.     Households in Tx1 will receive inactive high efficiency particulate air (HEPA) devices and     will serve as the placebo group. Households in Tx2 will receive a new EPA-certified     woodstove, while households in Tx3 will receive active HEPA devices. The Secondary Aims of     this study are to assess the impact of these interventions on residential PM2.5 exposures and     other health outcomes. Secondary exposure outcomes measured prior to and following the     intervention will include PM2.5 mass, chemical woodsmoke markers on PM2.5 filters (including     levoglucosan and abietic acids), and biomarkers of woodsmoke exposure. Secondary     asthma-related health outcomes measured prior to and following the intervention will include     peak expiratory flow (PEF) and forced expiratory volume in first second (FEV1), biomarkers in     exhaled breath condensate, and frequency of asthma symptoms, medication usage, and healthcare     utilization. To our knowledge, this will be the first randomized trial in the US to utilize a     woodsmoke intervention to assess the impact of the consequent reductions in indoor PM on     health outcomes in a susceptible population. The results from this project will be     translatable to other regions in the US and the world where biomass burning is commonly used     for heating and cooking.   "
226241|NCT00807196|"     The purpose of this study is to investigate the ability to combine a radioactive medication     directly targeted against lymphoma cells with the immune effects of an allogeneic blood stem     cell transplant.   "
226242|NCT00807209|"     To review safety and effectiveness of two doses compared to current standard of care.   "
226243|NCT00807222|"     This study involves research to test how Vyvanse (study drug) affects sleep in 24 children     aged 6 to 12 years who have ADHD. Vyvanse is approved by the FDA for the treatment ADHD of in     children aged 6 to 12 years. The experimental part of this study is to determine how Vyvanse     affects sleep.   "
226244|NCT00807235|"     To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by     nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress     syndrome (RDS) in premature infants.   "
226245|NCT00807248|"     To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses     of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of     treatment in patients with Major Depressive Disorder   "
226246|NCT00807261|"     To determine the activity of weekly Docetaxel and Gemcitabine in patients with advanced soft     tissue sarcoma previously treated with anthracycline and/or ifosfamide        1. Primary endpoint: response rate        2. Secondary endpoint: progress-free survival, overall survival, safety   "
226247|NCT00807274|"     Impaired kidney function is associated with a poor outcome in patients with heart failure but     it is not known of this is the case for patients who have been born with their heart     condition (congenital heart disease). This study aims to investigate how frequently patients     with congenital heart disease have kidney disease and whither this does have an impact on     their outcome. The hypothesis is that kidney dysfunction will be common in these patients and     may have an impact on long-term health and life-expectancy.   "
226301|NCT00815126|"     This study aims to compare the efficacy of nasal provocation test with     Lysine-Acetylsalicylate in patients with history of NSAIDs hypersensitivity between     mucocutaneous symptoms and respiratory symptoms and laboratory outcomes.   "
227275|NCT00827593|"     The purpose of this study is to examine the effectiveness of 3 behavioral weight loss     programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined     approach which includes university-based treatment followed by Weight Watchers.   "
226248|NCT00807287|"     In patients with high gastric residual volumes jejunal feeding is recommended. Jejunal     feeding tubes can be placed in different ways. The endoscopic technique yields a success rate     between 90 and 98% for a correct jejunal placement. However, it requires endoscopic equipment     and trained staff. In contrast in small uncontrolled trials different unguided techniques     resulted in success rates up to 75%, only. In this prospective randomized trial the success     rate of a correct jejunal placement with the endoscopic technique is compared with the     unguided frictional technique. The investigators hypothesize that the success rate of the     unguided frictional placement method will be lower than the success rate of the endoscopic     method.   "
226274|NCT00814164|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving clofarabine together with     daunorubicin works in treating older patients with newly diagnosed acute myeloid leukemia.   "
227373|NCT00822211|"     The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid     compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM     inadequately controlled by metformin alone.   "
226249|NCT00807300|"     Percutaneous, image-guided tumor ablation has evolved as a genuine alternative for the     treatment of unresectable hepatocellular carcinoma. Published data exploring stereotactic or     proton beam percutaneous irradiation have revealed,that hepatocellular carcinoma (HCC) is     radiosensitive to certain protocols. In Phase I and II studies, the investigators     investigated the potential role of local irradiation in primary and secondary liver tumors     employing a Iridium192 source. The promising results of previous studies indicate that     CT-guided brachytherapy might play a role in the treatment of unresectable HCC.      Therefore, the investigators started a randomized, controlled, clinical Phase-II study to     evaluate the efficacy and survival-benefits of brachytherapy versus transarterial     chemoembolization in patients with unresectable HCC.   "
226250|NCT00807313|"     Patients with oligometastatic colorectal cancer (5 metastases or less) receive a combination     of systemic treatment and often local treatment, such as surgery, radiofrequency ablation and     more recently stereotactic body radiotherapy. The aim of this study is to register the     results and side effects of stereotactic body radiotherapy (SBRT) by means of helical     tomotherapy in the treatment of oligometastatic colorectal cancer.      The trial has two cohorts. Patients in cohort I get consolidation SBRT after best response on     first line chemotherapy. Patients in cohort II get SBRT when there is progression under, or     no indication for (further) chemotherapy. The primary endpoint is to evaluate the metabolic     complete remission rate three months after the start of radiotherapy.   "
226251|NCT00807326|"     A comparison of three medications to treat diarrhea in adults.   "
226252|NCT00807339|"     This is a dose escalation study using the CyberKnife radiotherapy device for small surgical     or medically untreatable renal tumors. Patients with renal tumors 5cms or less in diameter     will be accrued onto this study. The ability of CyberKnife to ablate these renal tumors and     maintain renal function with dose escalation will be assessed.   "
226253|NCT00807352|"     The aim of this study is to evaluate the validity and the reproducibility of the canadian     triage and acuity scale when applied by regular nurses for the triage of children in the     Emergency Department.   "
226254|NCT00807365|"     The purpose of the study is to evaluate the effect of a naturally occurring hormone, called     Growth Hormone Releasing Hormone (GHRH), on the muscle, bone and fat tissues of the body.     GHRH stimulates the production of growth hormone (GH), which regulates the build up of many     tissues in the body, including muscles and bones. Many elderly people have low levels of GH.     The overall goal of this research is to determine the effectiveness of GHRH to raise levels     of GH and improve these body tissues. The purpose of the tests is to measure how the body     handles sugar, fat, and proteins. GH can affect your body's use of sugar, fat and proteins.   "
226255|NCT00807378|"     This study of neurotropic viral infection and Tuberculous CNS infection is the comprehensive     investigation of CSF PCR arrays (Hybrydiaztion technique,Sybergreen and Taqman real time PCR     arrays of CSF ) in suspected cases of viral CNS infection, Tuberculous CNS infection in both     AIDS and non AIDS patients.      Patients with clinical viral encephalitis and all meningoencephalitis including all patients     with HIV/AIDS CSF and non AIDS will be banked and test for RNA and DNA viral sequence by Real     time PCR arrays and IS6110 gene of Mycobacterium tuberculosis. Clinical data and final     diagnosis will be used to analyze the result of this PCR arrays technique compared to     clinical gold standard criteria.   "
226256|NCT00807391|"     The aim of this study is prospectively to determine the diagnostic sensitivity of     Transbronchial Catheter Aspiration (TBCA) in comparison with Transbronchial Needle Aspiration     (TBNA) in the diagnosis of peripheral nodules and masses of the lung.   "
226257|NCT00807404|"     RATIONALE: New diagnostic procedures, such as optical coherence tomography, may be effective     in finding tumor cells.      PURPOSE: This clinical trial is studying optical coherence tomography in tissue samples from     women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial     neoplasia.   "
226258|NCT00807430|"     To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms     and at the jaw muscle activity during sleep.   "
226259|NCT00807443|"     The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with     a viral load below 50 copies/mL is the main limitation to eradication of the virus from the     body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore,     patients are obliged to continue with treatment for a period calculated to be greater than 60     years.      Despite the important advances in knowledge of the biology of this reservoir, we still have     no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the     first time with an integrase inhibitor is exceptional, since the results could provide     important information on the nature of this reservoir.      If maintenance of the reservoir is a dynamic process, inclusion of an integrase inhibitor is     expected to lead to a reduction in the size of this reservoir. This effect could be critical     when including IAT (viral reactivation), since, in theory, it would be necessary to act on a     smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of     the viral reservoir (approximately 1,000,000 cells).      The study has also been designed to enable us to understand the biochemical and molecular     mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step     to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.   "
226260|NCT00807456|"     The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA     TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is     sloped in a lingual to buccal direction.      The hypothesis is that the sloped marginal contour of the implant will help preserve the     lingual/palatinal marginal bone.   "
226272|NCT00814138|"     Myasthenia gravis is a rare neuromuscular disorder characterized by weakness and fatigability     of ocular, bulbar, and extremity musculature. The specific aim of this study is to determine     if oral methotrexate is an effective therapy for myasthenia gravis (MG) patients who are     prednisone dependent. Patients will be randomized to receive either methotrexate or placebo     and those who are entered onto this trial will have symptoms and signs of the disease while     on prednisone therapy. The hypothesis is that adding methotrexate therapy in these patients     will improve the MG manifestations so that the prednisone dose can be reduced and clinical     measures of MG severity will improve.      Funding Source - FDA OOPD   "
226261|NCT00807469|"     COPD is ranked number 3 by the WHO list of important diseases worldwide and is the only     disease with increasing mortality. The pathogenesis of cigarette smoke-induced COPD is     obscure, therefore more insight is needed to design effective anti-inflammatory agents. We     hypothesize that healthy individuals who are susceptible to smoking demonstrate a higher and     aberrant inflammatory response to cigarette smoke. This susceptibility is caused by     heterogeneous factors and is associated with various polymorphic genes that interact with     each other and with the environment.      Objective:        -  To define mediators involved in the early induction of COPD in susceptible smokers (and          so to define new drug targets)        -  To develop new biological and clinical markers for the early diagnosis and monitoring of          COPD        -  To compare between susceptible and non-susceptible individuals the corticosteroid          responsiveness of bronchial epithelial cells in vitro, and to study the mechanisms of          smoking-induced corticosteroid unresponsiveness.        -  To study the role of candidate genes that may play a role in the development of fixed          airway obstruction, and to identify clues for patient's responsiveness to specific          drugs.   "
226262|NCT00807482|"     The overall short-term goals of this project include the following: 1) identify the genes     that are key to the function of respiratory cilia to protect the normal lung; and 2) the     effects of genetic mutations that adversely affect ciliary function and cause primary ciliary     dyskinesia (PCD), which results in life-shortening lung disease. The long-term goal of this     project is to develop better understanding of the underlying genetic variability that     adversely modifies ciliary function, and predisposes to common airway diseases, such as     asthma and chronic obstructive pulmonary disease.   "
226263|NCT00807495|"     This is an open-label, multicenter, phase 2 study of alisertib a/k/a MLN8237 in patients with     relapsed or refractory non-hodgkin's lymphoma.   "
226264|NCT00807508|"     In the present study the investigators aim to determine whether leucine supplementation can     augment muscle mass and strength and improve body composition in healthy elderly men   "
226265|NCT00807521|"     The stress response as induced by myocardial cellular damage during cardiac surgery may lead     to myocardial stunning and apoptosis, and could therefore impair postoperative patient     recovery. Surgical trauma typically induces the liberation of cytokines. Some of these     cytokines are strongly associated with the initiation of intracellular proapoptotic pathways     through activation of tyrosine kinases and integrins. The latter are known for their     deteriorating effects on cardiac function and are strongly involved in cardiac remodeling.     Dexamethasone is typically administered prior to cardiac surgery in order to especially     reduce the release of proinflammatory cytokines. It has however never been investigated     whether this additionally reduces proapoptotic signaling in the human heart, thereby     eliminating risk factors for the induction of cardiac dysfunction. In the present study, the     investigators therefore aim to investigate whether dexamethasone inhibits proapoptotic     pathways in patients undergoing cardiac surgery. Furthermore, the investigators would like to     elucidate whether this proposed effect of dexamethasone is related to the reduction of the     stress response in the heart or indirectly by suppression of cytokine release. For this     purpose the investigators will obtain cardiac biopsies and plasma from patients, who are     randomly assigned to placebo or dexamethasone treatment and undergo on and off-pump coronary     artery bypass grafting (CABG) surgery.   "
226266|NCT00807534|"     This study was designed to test the following hypothesis:      The 3-min constant rate step test and the 3-min constant rate shuttle walk test will be     sensitive to detect improvement in exertional dyspnea following acute bronchodilation in     patients with COPD.   "
226267|NCT00807547|"     Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing   "
226268|NCT00807560|"     The purpose of this study is to determine whether a parent/guardian intervention for     adolescent overweight/obesity more effective than a nutritional counseling education     curriculum for reducing body mass index z-score (BMI Z-score) and related outcomes.   "
226269|NCT00807573|"     The purpose of this study is to determine the percentage of patients with non-small cell lung     cancer that will experience a shrinkage of their tumors following treatment with three     medications given together: paclitaxel, pemetrexed (Alimta®), and bevacizumab (Avastin®).     Each of these medications has been approved by the FDA for patients that have not received     any treatment for their lung cancer. This study is designed to study the effects of all three     drugs given at the same time.      Each of these medications has been studied in lung cancer and is commercially available.     Paclitaxel and pemetrexed are traditional chemotherapy drugs. Bevacizumab is a monoclonal     antibody, which means that it attaches to a specific target. Bevacizumab attaches to a     protein in the blood stream called Vascular Endothelial GrowthFactor (VEGF). VEGF helps     tumors grow new blood vessels to feed themselves, and bevacizumab is thought to help block     this new growth of blood vessels and starve the tumors of the nutrients they need.   "
226270|NCT00807586|"     Radiofrequency ablation is an effective treatment for atrial fibrillation. However, about 20%     of the time the atrial fibrillation recurs. Steroids given after the ablation may decrease     inflammation caused by the ablation and thus improve healing and decrease the chance of     recurrence of atrial fibrillation.      In this study patients will be randomized to receive intravenous steroids or not immediately     following the ablation.   "
226271|NCT00807599|"     The purpose of this study is to compare the effects, good and bad, of two ways to treat     patients with standard-risk symptomatic multiple myeloma. Patients with standard-risk myeloma     have myeloma with specific features: levels of 2 blood tests have to be in a specific range     and there can be no myeloma tumors found outside of the bones or bone marrow, the areas where     myeloma is usually discovered. In past clinical studies, patients with standard-risk myeloma     have done well with intensive therapy in the form of stem cell transplant. But multiple     myeloma is not curable and, although it may respond to standard treatments including stem     cell transplant, myeloma always recurs.   "
226302|NCT00815139|"     Neointimal coverage over stent strut is important for preventing the stent thrombosis. But,     there is no data for the duration of complete formation of neointima om zotarolimus eluting     stent (ZES). Previously the investigational observational data at 9 months showed most of     stent strut was covered with neointima. Therefore, the investigators investigated the     evaluation of neointimal coverage on 3 months after ZES implantation using novel OCT system,     which is powerful intravascular imaging system having the higher resolution power.   "
226275|NCT00814177|"     Warfarin is very effective for the prevention of blood clots (thrombosis). A test of     coagulation, the prothrombin time (PT) is used to monitor the effect. The PT response to     warfarin can fluctuate as a result of interactions with a large number of other drugs, food     or herbal agents as well as for no apparent reason. Thus, frequent monitoring of the PT and     dose adjustments according to the results are required. One third of our patients remain on     the same maintenance dose over 6 months. However, also these patients sometimes have a PT     result moderately outside the therapeutic range without any obvious explanation. Too short     PTs may be due to missed dose(s) or more dark green vegetables in the diet. Too long PTs may     be due to a course of antibiotic therapy or less dark green vegetables. Laboratory errors may     also occur and can cause deviations in any direction. Most likely, unnoticed fluctuations in     the PT occur as well between the time points of monitoring.      There are no guidelines on how to manage the treatment in this situation but there are some     typical behaviours.      Behavior A: Some physicians simply let the patient continue with the same dose. It is     extremely unlikely that the very temporary dose adjustment has any effect on the PT result 4     weeks later and this is a cosmetic procedure. Behavior B: Others recommend the patients to     take ½ - 1 additional dose in case of short PT and to skip a dose or take half dose in case     of long PT, and thereafter to continue with the usual dose. The investigators need to     quickly correct the temporary aberration in order to avoid thrombotic or bleeding     complications the next few days.      This may seem like an issue of no importance. The investigators are however performing a     series of studies to evaluate if these stable patients can be managed with blood tests less     often than every 4 weeks. For that purpose it is important to know how often and why aberrant     results occur, the implication and to what extent they can be ignored.      The investigators hypothesis is that in patients with very stable PT-results and unchanged     dose for 3 months, should continue with exactly the same maintenance dose, even when the     result unexpectedly is slightly above or below the therapeutic range. The investigators     believe that most of these occasional PT-results outside the therapeutic range are due to     laboratory errors, perhaps missed doses by the patient or temporary change in diet or     medications.   "
226276|NCT00814190|"     Management of diabetes is an evolving challenge to health care professionals. The     fluctuations of glucose levels over the lifetime of patients with diabetes can lead to     complications such as nephropathy, neuropathy, retinopathy and cardiovascular diseases.     Although diabetes is a chronic disease, it can be controlled with use of medications (pills     or insulin), and/or changes in life-style and diet. These interventions are aimed at keeping     the blood glucose levels normal or in the range of acceptable levels.      An important aspect of diabetes care is the monitoring of blood glucose levels in order to     assess the effectiveness of treatment and to modify the treatment to achieve the desirable     glucose levels. Patients with type 2 DM treated with insulin are recommended to perform     testing for their blood glucose levels; however, it often requires intervention by health     professionals in order to prevent the immediate and serious complications of hyper or     hypoglycemia. The frequent self-monitoring of blood glucose and effective interventions by     the health professionals may eventually allow tighter control of blood glucose levels and     delay or prevent the complications associated with diabetes.      In this study, the investigators wish to evaluate the effect of an Internet based remote     monitoring system that allows for patients to upload their blood glucose readings online and     for the health care professional to view and provide feedback or therapeutic intervention.     The Internet based system has the features of presenting the blood glucose readings according     to the time of day and automatically calculates the daily average plus the standard     deviation. A visual graph of the glucose readings over a 24-hour period is also generated for     view. In addition, the doctor can give feedback by sending messages through the system. The     patient's personal information is kept secure as outlined by the privacy policy of the     Internet based system and only the doctor and the patient can view the uploaded glucose     readings.      The investigators propose that the standardized encounters using the Internet will improve     the outcome of treatment for patients with type 2 DM.   "
226277|NCT00814203|"     To develop a cohort of COPD participants to assist study staff in determining the most likely     candidates for future studies.   "
226278|NCT00814216|"     This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week     administration of oral QAV680 in the treatment of patients with asthma.`   "
226279|NCT00814229|"     H9N2 influenza circulates in animal and poultry and has caused delf limiting infections in     children. Influenza H9N2 poses a pandemic threat to humans.      This study evaluates the safety and immunogenicity of adjuvanted and non-adjuvanted whole     virus and virosomal H9N2 vaccines by the intramuscular route. We also assess intradermal     route of administration to see if this has any advantages. The aim is to assess antibody     responses before and after vaccination. The hypothesis is that lower doses of adjuvanted     vaccine will induce similar antibody responses to non-adjuvanted vaccine   "
226280|NCT00814242|"     This study will compare and analyze the difference between hepatectomy at deep and complex     sites(adjacent to major blood vessels) of patients with HCC and PRFA prognosis, recovery     after treatment as well as incidence of complications so as to establish treatment standards     of HCC at these sites.   "
226281|NCT00814255|"     This project will test whether adalimumab,and/or galactose can safely reduce proteinuria     (abnormal amounts of protein in the urine) and protect kidney function better than standard     treatment for patients with focal segmental glomerulosclerosis (FSGS).   "
226282|NCT00814268|"     Primary objective:        -  Comparison of efficacy of the combination therapy (clopidogrel plus aspirin) and the          aspirin alone (main comparison) to prevent any recurrent ischemic lesion .      Secondary objectives:        -  Comparison of Modified Rankin scale (mRS) scores;        -  Comparison of the Incidence of all kinds of stroke and vascular death;        -  Comparison of the Incidence of bleeding episodes (major and minor) and symptomatic          intracerebral hemorrhages during the follow-up period.   "
226283|NCT00814281|"     The purpose of this study is to examine biological pathways of altered blood vessel function     resulting from breathing airborne particulate. Blood artery function in healthy men will be     measured after particulate exposure either on placebo or on an asthma medication that stops     production of an inflammatory biological agent. Lung and blood profiles will be obtained     before and after exposure to exhaust fumes. We believe that the inflammatory agent produced     by the lungs from breathing these particles causes abnormal artery function.   "
226419|NCT00816660|"     The objectives of this study are to evaluate the immediate tolerability and safety of     rVWF:rFVIII in subjects with Type 3 Von Willebrand Disease after administration of various     dosages of VWF:RCo.   "
226284|NCT00814294|"     The primary objective of this trial is to compare the reduction in mean glycated hemoglobin     levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on     background metformin therapy at the end of 18 weeks of treatment.      The secondary objectives are:        -  To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test,          fasting plasma glucose (FPG), insulin, homeostasis model assessment of insulin          resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β),          frequency of hypoglycemic events, body weight, and lipid levels; and        -  To evaluate the safety and tolerability of oral HDV-I.   "
226285|NCT00814307|"     This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550     when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to     severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in     improving signs and symptoms and physical function that were observed in the Phase 2     Rheumatoid Arthritis studies.   "
226286|NCT00814320|"     The purpose of the study is to develop a subcutaneous treatment option for participants with     Primary Immunodeficiency Diseases (PID) that allows an administration of Immune Globulin     Intravenous (Human), 10% at the same frequency as IV administration.   "
226287|NCT00814333|"     Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally     epistaxis can be severe enough to require emergency room admission. Among the treatment     options for epistaxis, nasal packing is the most common approach. This approach requires a     return visit to the clinic for removal of the packing. Additionally, there is a great deal of     pain during the insertion and removal of this packing. This study aims to justify the further     investigation of thrombin as a potential treatment approach for these patients. Thrombin     could provide a treatment approach that reduces pain and eliminates the need for a return     visit to the clinic.   "
226288|NCT00814346|"     The aim of the study is to evaluate the effect of EGb761®, in comparison to placebo, on     cerebral glucose metabolism, in three groups of elderly patients: newly diagnosed mild     Alzheimer's disease (AD), memory complaint patients with cognitive impairment (MC) and memory     complaint patients cognitively normal (CNE). The first phase includes four weeks treatment     with EGb761® for all groups, with change in brain glucose metabolism at month 1 using 18     FDG-PET, as primary endpoint which will be followed by an open 17 months follow-up (FU)     period with EGb761® treatment in MC and CNE patients.   "
226289|NCT00814359|"     Radiation treatment is very effective for treating cancers of the head and neck, however,     during the course of treatment, it is common for patients to experience soreness of their     mouth and throat due to the radiation. When radiation causes inflammation of the inside of     the mouth, it is called 'mucositis'. There are several mouthwashes that are commonly used to     prevent and treat mucositis, but none of these have been shown to be superior to another.     This study is being conducted to see if using a combination of magic mouthwash and sucralfate     is better than using a single mouthwash called benzydamine at decreasing the burden of     mucositis.   "
226290|NCT00814372|"     To define the relative efficacy, safety and tolerability profiles of oral daily MBX-102 at     daily doses of 400 and 600 mg vs. placebo and Actos® 30 mg (up-titrated to 45 mg after 8     weeks) when administered for up to 24 weeks in patients inadequately controlled with a stable     dose of metformin (≥ 1500 mg/day).   "
226291|NCT00814385|"     This study focuses on pre-pandemic priming of man against H5 influenza with the goal of     mounting a robust antibody response to small quantities of vaccine either before or during an     H5 pandemic.   "
226292|NCT00814398|"     The aim of this project is to study the best number (1 or 2)and day (3 vs 5)of embryo     transfer in good prognosis patient.   "
226293|NCT00814411|"     This study uses a randomized, noninferiority design to determine whether group family     planning counseling is as effective as individual family planning counseling among     gynecological patients with unmet need at two teaching hospitals in Ghana.   "
226294|NCT00814424|"     The study hypothesis is that a modified smart bite block system can deliver up to 10     liters/minute of supplemental oxygen orally with the CO2 monitoring performance substantially     equivalent to the currently marketed smart bite block that delivers oxygen up to 5     liters/minute   "
226295|NCT00814437|"     The aim of this project is to study the physiological role of the KiSS-1/GPR54 system in the     granulosa cells of the human ovary.   "
226296|NCT00814450|"     This study is intended to provide clinical data regarding safety and accuracy of the     ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.   "
226297|NCT00814463|"     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and     cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill     any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating     patients with brain metastases.   "
226298|NCT00815087|"     The purpose of this study is to determine whether functional electrical stimulation is     effective in the treatment of dysphagia due to nasopharyngeal cancer post radiotherapy   "
226299|NCT00815100|"     The purpose of this study is to investigate whether a pure heart rate-lowering agent     (Ivabradine) reduces vascular inflammatory stress in patients with acute coronary syndromes   "
226300|NCT00815113|"     Introduction: Gastric cancer is the world's second largest cause of cancer related deaths. In     the Western world, as well as in Israel, this malignancy is less prevalent than colorectal     cancer, but has higher morbidity and mortality. First degree relatives of patients with     gastric cancer have a 1.5-fold to 3-fold increased risk of developing gastric cancer     themselves. In relatives of gastric cancer patients who are also carriers of a CagA positive     strain of Helicobacter pylori, the risk is 8-fold. Mucosal atrophy, hypochlorhydria, high     lymphoid follicle density, pan gastritis, and interleukin 1 β polymorphism are frequent in     family members of gastric cancer patients and are associated with increased risk of the     disease.      Aims:        1. To characterize the high risk individual for gastric cancer development.        2. To establish a screening plan for early detection and prevention of gastric cancer in          first degree relatives of gastric cancer patients.        3. To validate new procedures for assessing risk factors for development of gastric cancer:          gastric acid output, gastric mucin output, serum levels of pepsinogen I, pepsinogen II,          gastrin B12, Helicobacter pylori status [serology, histology, urease test, 13C-urea          breath test (13C-UBT)].        4. To assess genetic changes in the gastric mucosa of the screenees in comparison with          gastric cancer patients and controls.      Methods:      We will approach 50 gastric cancer patients treated in Rabin Medical Center, and ask for     their consent to approach first degree relatives for participating in the study. For each     gastric cancer patient 4 relatives will be asked to signed an informed consent and undergo     the study procedures. For each participant a matched control for age, sex and background     diseases, out of consecutive gastro esophageal reflux disease (GERD) patients undergoing     gastroscopy, will be asked to join the study. Thus, we will screen 50 gastric cancer     patients, 200 first degree relatives of gastric cancer patients, and 200 controls.   "
226303|NCT00815152|"     1. Purpose and Objective:           To determine the feasibility and short- and long-term efficacy of an empirically-based          CST intervention (Keefe et al.) with caregivers of patients with primary malignant brain          cancer.        2. Study Activities and Population Group:           The target sample will be 20 caregiver-patient dyads. Using a randomized controlled,          prospective design, potentially eligible participants will be identified at the time of          initial consultation (see Figure 1). Outcomes will be assessed at baseline,          post-intervention (3 months post-randomization), 6 months post-randomization, and every          4 months up to 2-years in the event that the patient dies.        3. Data Analysis and Risk/Safety Issues:      With only 10 subjects per group we do not have statistical power for direct hypothesis     testing. Nevertheless, p-values will be presented for some analyses (chi-square tests,     t-tests, and Spearman correlations) simply to aid in interpretation of results. In no way     will these p-values be used to declare statistical significance or non-significance of the     test results. Accordingly, the primary focus will be the means, variances, and covariances of     the study endpoints, as well as the change scores in these endpoints across the study     intervention and their 95% confidence limits.   "
248424|NCT01101360|"     The purpose of this study is to evaluate the efficacy and safety of the Matrix RF for Port     Wine Stains based on clinical and histological analyses.   "
226304|NCT00815165|"     Cytomegalovirus (CMV) is an important cause of illness and occasional deaths in infants who     catch the virus before they are born, in newborns, and in children and adults who have weak     immune systems. The purpose of this study is to look at how the CMV vaccine works in the     blood. This study is being done along with the main CMV gB/MF59 vaccine study that looks at     how the overall body reacts to the vaccine. Participants will include up to 100 healthy     adolescent female subjects aged 12 to 17 years who were vaccinated in study 04-039 and 100     subjects that were screened for 04-039 to participate as controls. Study procedures will     include up to 6 blood draws taken over a 13 month period. Participation will be about 31     months (unless the patient enrolls into the shedding study).   "
226305|NCT00815178|"     The purpose of the study is to determine if inspiratory muscle training improves inspiratory     muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness.   "
226306|NCT00815191|"     The primary objective of this study is to determine if the intraoperative distal esophageal     (core) temperature with vitalHEAT warming is non-inferior to upper-body forced-air warming in     patients undergoing open colectomy under general anesthesia. This is a randomized study.   "
226307|NCT00815204|"     Approximately, post-traumatic stress disorder (PTSD) occurs in 8% of the adult population     over time. Exposure to traumatic events increases the risk of poor physical health and often     leads to disability. The biology of PTSD is continually being explored in order to help find     better treatments for this debilitating disorder. In our study, we propose to further our     understanding of PTSD. Prior research has found that patients with PTSD have changes in the     stress hormone pathway. In this pathway, there is release of certain hormones from the     pituitary gland in the brain that feed into the blood stream and tell the adrenal gland to     produce stress hormones.      The pituitary is a gland located at the base of the brain which controls the hormones in the     body, including the stress hormones. Research in other psychiatric disorders has found     changes in the pituitary volume along with changes in the hormones. This has not been     investigated yet in PTSD. Therefore, we propose in our study to measure pituitary volume in     people with PTSD and look at the changes in the stress hormone pathway. Moreover, we will     investigate whether other hormones are affected by PTSD. In this way, we can further our     understanding of the the biology of PTSD and help develop new therapies which can intervene     through the hormonal system.   "
226308|NCT00815217|"     A prospective, single blinded randomized clinical study will be performed to determine if the     injection of lipoaspirate into diabetic or venous stasis wounds promotes wound healing or     wound closure at a faster rate than conventional treatment.   "
226309|NCT00815230|"     The clinically widely used X-ray computed tomography examination has a low-grade radiation     effect and recently has attracted much attention concerning the possible adverse effects of     radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells     mainly because it can interact with water (which makes up to 80% of cells) to generate     reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we     can reach, there is no report concerning the relation between X-ray computed tomography     examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if     the cardiac computed tomography angiography (cardiac CTA) may induce a higher level of ROS in     the peripheral blood.      Study subjects will be OPD patients who are arranged for cardiac CTA examination because of     suspect coronary artery disease (CAD). In total, twenty cases will be enrolled for the study.     The formal consent will be delivered and explained to the patients and families after the     arrangement of cardiac CTA. It then will be retrieved just before the performance of cardiac     CTA.      For each enrolled case, peripheral blood will be sampled three times (once before and twice     after the performance of cardiac CTA). Totally 60 blood samples will be collected from 20     study subjects within 3 months (January 1 ~ March 31, 2009). ROS level in the collected blood     samples will be then measured, compared, and analyzed.   "
226310|NCT00815243|"     The purpose of this study is to determine whether telemedicine consultations (lead by     standard scheme)allows to increase quality of anatomical and functional outcomes and improve     clinical work-flow at patients with acute bone and joint trauma, hip pathology and congenital     orthopedics abnormalities.   "
226311|NCT00815256|"     The purpose of this study is to evaluate the effectiveness of collagen cross linking (CXL) in     reducing progression of mild and moderate progressive keratoconus.   "
226312|NCT00815269|"     Previous studies on animals suggest that inhalational anesthetics can reduce vascular tension     in vitro resulting in vasodilation and decrease in blood pressure. This role for inhalational     anesthetics has essential clinical implications such as the condition of sepsis or septic     shock or other shock-associated states during which the blood vessel constricts strongly and     leads to circulation dysfunction. The vasodilation property of these anesthetics including     halothane, isoflurane, sevoflurane, desflurane and enflurane enables them to be better     options than other general anesthetics in many clinical conditions needing the vasculature to     be dilated. The investigators hypothesized that these inhalational anesthetics can evoke     vasodilation measured with ultrasonography during general anesthesia in vivo as the in vitro     studies displayed.   "
226322|NCT00815399|"     Type 2 diabetes is an epidemic. Its long-term consequences translate into enormous human     suffering and economic costs; however, much of the morbidity associated with long-term     microvascular and neuropathic complications can be substantially reduced by interventions     that achieve glucose levels close to the nondiabetic range. However, none of the recent     intervention studies has demonstrated a benefit of intensive glycemic control on their     primary CVD outcomes.      The investigators report the findings of a long-term randomized and comparator-controlled     clinical trial conducted in patients with newly-diagnosed type 2 diabetes. The investigators     compared the effect of pioglitazone with that of metformin on circulating endothelial     cell-derived submicroscopic membranous vesicles, termed microparticles: because of their     putative role in inflammatory processes and their ability to directly affect endothelial     functions, they are gaining increasing popularity as a surrogate marker of cardiovascular     outlook. Metformin was chosen as a comparator because the American Diabetes Association     recommendations suggest to start therapy in newly-diagnosed type 2 diabetic subjects     combining a drug (metformin) with lifestyle changes. Moreover, the mechanism of action of     pioglitazone is distinct from that of metformin.   "
226313|NCT00815282|"     In the Netherlands, the human Papillomavirus (HPV) vaccination will be added to the National     Vaccination Program for girls to protect against the development of cervical cancer. The     vaccine protects against HPV type 16 & 18, which cause about 75% of cervical cancer. Studies     have shown that the vaccine is effective in healthy subjects in preventing infection by HPV     16 & 18. However, no evidence exists on the immunogenicity and safety of HPV vaccination in     patients with an immune system disorder, such as primary humoral immunodeficiency (i.e.     hypogammaglobulinemia) or autoimmune diseases. Concerns exist that vaccination may cause an     aggravation of the underlying disease. In addition, the immune response to vaccination may be     diminished due to immunosuppressive therapy or the underlying disease.      Objective: The primary goal of the current study is to study the immunogenicity of HPV     vaccination in patients with an autoimmune disease and a primary humoral immunodeficiency.      Based on retrospective analysis with other vaccines we hypothesize that patients with     autoimmune diseases who are under immunosuppressive medication and patients with a immune     system disorder have a decreased serological response to HPV vaccination, and that the     produced HPV antibodies titers decrease more rapidly than in healthy individuals.      The secondary objective is to explore safety of HPV vaccination and immune regulatory     mechanisms induced by vaccination in a subset of patients. The investigators hypothesize that     HPV vaccination is safe and that HPV-induced regulatory T cells are able to prevent an     increase in the activity of an autoimmune disease.   "
226314|NCT00815295|"     In this Phase I B/II trial, we seek to determine the safety and efficacy of sorafenib with     standard dose cetuximab in the treatment of patients with Recurrent and /or Metastatic     Squamous Cell Carcinoma of the Head and Neck (SCCHN).   "
226315|NCT00815308|"     The purpose of this study is to determine whether the treatment of locally advanced     esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel,     cisplatin and radiation improve clinical outcomes.   "
226316|NCT00815321|"     This is an extension of our ongoing clinical trial using ex vivo expanded autologous     Cytokine-induced killer (CIK) cells as an adoptive cellular immunotherapy for haematological     malignancies. The pre-existing clinical trial targets patient with acute myeloid leukemia or     MDS, and relapsed disease post allogeneic transplant.      Chronic myeloid leukemia (CML) is a disease with good response to kinase inhibitors. There     are however patients in transformed phase of the disease who do not respond to these     treatment. A small proportion of patients with response to Imatinib may develop mutations     resulting in drug resistance. In addition, the vast majority of patients with a good response     to the kinase inhibitors still have persistent CML cells detectable at a molecular level. It     is known that the CML progenitors are not sensitive to the kinase inhibitors. On the other     hand, immune mediated mechanism is known to be able to eradicate CML as shown by efficacy of     donor lymphocyte infusion in the allogeneic transplant setting. Early clinical trials have     shown clearance of bcr-abl using peptide vaccination. There is also convincing mouse data     showing eradication of CML at molecular level by autologous CIK cells, but no clinical trial     has been done using CIK cells for CML.      We therefore plan to expand our current CIK trial to include CML as a disease, for CML     patients with various degree of response to the kinase inhibitors which have already offered     its maximal effect. We aim to study whether autologous CIK cells may further improve disease     response, either in the eradiation of minimal residual disease, or in conjunction with     chemotherapy for control of high tumour load disease.   "
226317|NCT00815334|"     Endoscopic subureteral injection for vesicoureteral reflux has become an established     alternative to ureter reimplantation in children. Some recent studies suggest that ESI can be     also a primary treatment option for VUR in adults. However, the experience with ESI in adults     who have VUR associated with decreased bladder compliance is limited. We evaluated the     efficacy of endoscopic subureteral injection treatment for vesicoureteral reflux in adults     with decreased bladder compliance.   "
226318|NCT00815347|"     Hypothesis: The endothelin-1 receptor antagonist, bosentan when added to the treatment of     asthma patients who are symptomatic despite the use of controller therapy will improve asthma     symptoms and physiology.      Twenty patients with a diagnosis of asthma, between the ages of 21 and 70 who are symptomatic     despite the use of at least one controller medication will be randomized to either placebo or     active medication for an 8 week period (initial 4 weeks is at 1/2 of final dose as per     package insert and FDA approval). Measures of lung function and symptoms will be recorded.     Patients will then cross over, so that patients initially on placebo will receive active drug     for 8 weeks and those initially on active drug will receive placebo. The same endpoints will     be measured. The acute bronchodilator effects of the drug will also be tested on the first     day of therapy at the full therapeutic dose.   "
226319|NCT00815360|"     To investigate the role of ranibizumab and angiographically-directed peripheral scatter laser     therapy in patients with clinically-significant diabetic macular edema (CSME) and peripheral     nonperfusion. We propose a novel treatment of CSME in a subgroup of patients defined by a     combination of ultrawide-field angiography (UWFA) and optical coherence tomography (OCT).     Within this classification scheme, patients with CSME are subdivided by the presence of: 1)     focal macular leakage, 2) vitreomacular interface traction, and/or 3) peripheral     nonperfusion. The successful treatment of diabetic macular edema would be dictated by     pathophysiology-directed therapy based on this classification.      The subgroup of interest for this clinical trial is characterized by diabetic macular edema,     peripheral nonperfusion on UWFA, and the absence of macular traction on OCT. This group of     patients has previously not been well recognized or characterized due to limitations in     previous, standard angiographic evaluation of the retinal periphery.      We postulate that this subcategory represents one with a high rate of failure of accepted     therapies given persistence of the basic pathophysiologic mechanism for CSME, namely     ischemia-induced production of Vascular Endothelial Growth Factor (VEGF) from the retinal     periphery. This also represents a population of patients with likely recurrence of CSME     despite treatment with anti-VEGF therapy alone for the same reason.   "
226320|NCT00815373|"     Both Cosopt® and Xalatan® plus Timoptic® will significantly lower IOP, however only Cosopt®     will demonstrate positive hemodynamic effects. The clinical significance of this will be     investigated by examining the ophthalmic and short posterior ciliary arteries to determine     the blood supply to the optic nerve head, the site of damage in glaucoma   "
226321|NCT00815386|"     Improvement in heart failure with moderate to severe mitral regurgitation using a     percutaneously delivered implantable device residing in the coronary sinus   "
226324|NCT00815425|"     Rheumatoid arthritis (RA) is a long-term autoimmune disease that is characterized by pain,     stiffness, inflammation, swelling, and sometimes destruction of joints. RA usually requires     lifelong treatment, including medications, physical therapy, exercise, education, and     possibly surgery, but the course and severity of the disease can differ significantly from     person to person. The purpose of this study is to identify genetic and other factors that     determine the severity of RA in African Americans.   "
226325|NCT00815438|"     Surgical removal of the gallbladder is needed in 1 million people per year in the USA. The     procedure is done by placing four tubes (cannula) from 5 to 10 mm through the abdominal wall.     Air is placed in the abdominal cavity and a lighted scope is placed through one cannula. The     space in the abdominal cavity can then be seen on a video screen. Thin retractors and     dissecting instruments are placed through the other cannula and the gallbladder is removed     using the video screen for vision. The gallbladder duct and the artery are usually occluded     with clips or stitches.      In this study we propose to do the procedure though a single 5 mm incision placed at the     umbilicus and a second access through the vagina using a flexible endoscope. The gallbladder     will be retracted using strings (sutures) attached to the gallbladder. The dissection will be     done using laparoscopic instruments (scissors, knives, dissectors) placed through the     laparoscopic port. A flexible grasper may be used in the endoscope to help with retraction.     An endoscopic snare or grasper will be used to grasp the gallbladder and remove it from the     abdomen through the vagina.      This study evaluates the ability to do laparoscopic cholecystectomy with one skin incision     and one vaginal incision. This will provide the basis for future studies evaluating decreased     pain and costs with transvaginal assisted cholecystectomy.   "
226326|NCT00815451|"     This study aims to investigate the effect of polyphenol-rich dark chocolate (DC) on insulin     resistance, adiponectin , blood pressure (BP), lipid profile in obese subjects and determine     possible associations between all assessed parameters.      It hypothesizes that consumption of polyphenol-rich Dc could lower fasting glucose levels,     insulin resistance and improve BP, total cholesterol, low-density lipoprotein (LDL) and     triglycerides while increasing adiponectin and high-density lipoprotein (HDL) in overweight     or obese individuals.   "
226327|NCT00815464|"     Study Purpose:      The purpose of this study is to assess that Liquid Acupuncture(Herb Acupoints Injection)     Therapeutics could achieve permanent efficacy response in Chronic Hepatitis B.      Efficacy Assessment:      At cessation of the Treatment(about at 24 weeks)comparing Testing Data with the Normal     Criteria and their individual baseline.Continue for monitoring the Status 1-5 years.      Data Analysis:      Each 4 weeks collecting Patients' testing data and fill a table.A summary table will be     presented as frequency tables for categorical variables as number or percentage.   "
226328|NCT00815477|"     I-START is a randomized controlled trial that will evaluate the efficacy of an internet-based     program of behavioural counseling for adaptive lifestyle change to subjects diagnosed with     hypertension. I-START will be evaluated using objective outcome indices: systolic and     diastolic blood pressure, pulse pressure, and markers of vagal-heart rate (HR) modulation and     baroreflex sensitivity. The Heart and Stroke Foundation of Canada Blood Pressure Action     Plan(TM) (BPAP) will be adminisered over a 4-month period, and evaluated in a 2     (Intervention vs. Wait list Control) X 2 (Baseline vs. Post-Intervention) factorial design,     blocking for 3 recruitment sites (Toronto, London, the Grey Bruce region of Ontario, Canada),     and stratified for sex and age group (45-59, 60-74 years).   "
226329|NCT00815490|"     A cerebral oximeter is a device that uses light to measure the amount of oxygen within the     brain. It is similar to the device that measures the level of oxygen in the tip of the     finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the     forehead that both emits and detects the amount of light absorbed. This study will determine     how accurate the device is by comparing the displayed value on the monitor with blood samples     taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In     order to test the device over a suitable range, the level of oxygen within the blood will be     reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the     equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy     volunteers.   "
226330|NCT00815503|"     Pain treatment after periacetabular osteotomy is traditionally based on systemic opioids wich     have side effects. The purpose of this study is to evaluate the analgetic effect of wound     infiltration with local anaesthesia after periacetabular osteotomy.   "
226331|NCT00815516|"     The study will evaluate how effective and how safe the drug micafungin is when compared to     the drug amphotericin B deoxycholate in treating neonates and young infants with certain     fungal infections.   "
226420|NCT00816673|"     The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow     Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years     or more.   "
226332|NCT00815529|"     This research is planned to build a basis about effect of acupuncture for chronic low back     pain with economical efficacy.      It is consisted with two sub research. First,clinical research to know the effect of     acupuncture for chronic low back pain will be processed with acclate, randomized, patient,     outcome-assessor masking. 130 subjects would be collected and devided into two     groups(Experimental and placebo). Experimental group will undergo with real acupunture     treatment twice a week, for 6 weeks and acupuncture spots would be selected for each person     by clinical specialist. Placebo group will undergo with Park-sham needle and same 8     acupuncture spots would be used for all subjects also twice a week, for 6 weeks. The effect     will be accessed by VAS, x-ray, ODI, SF-36, EQ-5D, BDI before and the last treatments.      Second is qualitative research to make a basis through the economic evaluation and     satisfaction of acupuncture treatment for chronic low back pain. 15 persons who have been     treated at oriental medical hospital for chronic low back pain and 15 in experimental group     and 15 in placebo group who participate the clinical research will be collected and through     the personal interview, satisfaction about the treatment and economic efficacy will be     evaluated.   "
226353|NCT00815802|"     Direct DNA amplification, viral isolation and specific antibody measurement in saliva        1. From children in day care centers (samples collection will take place during a single          week)        2. From children coming at the emergency department of our hospital during a three months          period.      Sample collection will be done by the pediatrician the nurse, or one of the authorized     investigators of the study.   "
226333|NCT00815542|"     When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common     practice is to induce labor. Whenever the cervix is not ripened, there are several methods to     ripen the cervix, two of which are: mechanical, using a double balloon catheter and     pharmacological, with prostaglandins. The aim of the study is to compare those two methods of     cervical ripening for patients with significant oligohydramnion at term.      The study will be a prospective randomised trial.   "
226334|NCT00815555|"     The aim of the study is to examine whether tamoxifen-treated Israeli breast cancer patients     who are CYP2D6 poor metabolizers (CYP2D6*4/*4 genotype) are at higher cancer relapse risk     during 2.5-5-year follow-up period from initial diagnosis and primary treatment.   "
226335|NCT00815568|"     The purpose of this study is to evaluate the OS, RFS, and TRM after HCT with low-dose total     body irradiation, fludarabine, and busulfan conditioning.   "
226336|NCT00815581|"     Screening of refractory defect is one of major reason for amblyopy. Photorefraction is a new     method with some advantages in treatment of this problem. In this study the investigators are     going to compare the results of this surgery in children between 1 to 10 years old with     cycloautorefraction in children above 3 years old.   "
226337|NCT00815594|"     The occurrence of conjunctival scarring finally leads to the obstruction of the fistula tract     created by the filtering surgery. Vascular endothelial growth factor is thought to be a key     role in the formation of conjunctival scar, which play a pivotal role in the wound-healing     process. So it seems that the recombinant human anti-VEGF antibody could inhibit     angiogenesis, and reduce the conjunctival vascular formation in the wound-healing process     after glaucoma filtering surgery.   "
226338|NCT00815607|"     The purpose of this study is to test the safety of an investigational combination     drug/immunotherapy for the treatment of Stage III/IV melanoma.   "
226339|NCT00815620|"     A prospective observational study containing three arms comprising different therapeutic     measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms     include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor     radiotherapy.   "
226340|NCT00815633|"     The purpose of this study is to determine whether the biologic medication alefacept (Amevive)     is effective and safe in the treatment of Pityriasis Rubra Pilaris.   "
226341|NCT00815646|"     Immersion pulmonary edema (IPE) is a condition in which fluid fills the lungs during diving     or swimming, particularly in cold water. Some individuals appear to be predisposed to     developing IPE. DNA samples will be collected and stored, in order to compare the genetic     profiles of individuals who have experienced IPE with those who have not. In a few     individuals who have experienced IPE, we plan to measure the effects of cold water immersion     on the blood pressure, cardiac output and the pressures in the pulmonary artery. These will     be compared with similar measurements already obtained from normal individuals.   "
226342|NCT00815659|"     The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid     profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol,     triglyceride) in patients with metabolic syndrome.   "
226343|NCT00815672|"     The purpose of this study is to gain a better understanding of the mechanisms responsible for     cancer-related fatigue.   "
226344|NCT00815685|"     The data collected through this pilot study will allow us to increase our understanding of     cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our     long-term goal is to improve nutritional treatment and reduce illness in the cancer patient     population.   "
226345|NCT00815698|"     The investigators want to evaluate the effect of suturing the mesh versus using a     self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.   "
226346|NCT00815711|"     To establish a registry of patients for future studies of Inflammation in Interstitial Lung     Disease/Idiopathic Pulmonary Fibrosis.   "
226347|NCT00815724|"     The National Heart, Lung, and Blood Institute (NHLBI) has established guidelines for treating     people with asthma. This study will evaluate the effectiveness of a distance learning program     that aims to educate doctors on these guidelines, specifically the use of inhaled     corticosteroids to treat asthma in pediatric patients.   "
226348|NCT00815737|"     This study will determine if rhubarb will reduced the incidence of pneumonia and improved     recovery from an acute cerebral hemorrhage. The study is designed to look at both infection     rate and overall recovery and recovery of motor function, for example muscle strength and     coordination.   "
226349|NCT00815750|"     There are two parts to this study: (1) an information gathering phase leading to development     of a new decision aid (phase 1); and (2) a study to test the newly developed decision aid     (phase 2).   "
226350|NCT00815763|"     The purpose of this phase 3 study is to validate the efficacy and safety of ginsenoside-Rd     for acute ischemic stroke.   "
226351|NCT00815776|"     The purpose of this study is to characterize the safety profile and assess the effectiveness     of the CID in treating subjects with temporomandibular disorders (TMDs). This study is an     open-label, three arm, randomized, unblinded clinical trial with a pre-treatment screening     phase, a baseline visit and a 3 month treatment or exercise phase.   "
226352|NCT00815789|"     The goal of this study is to improve cardiovascular disease (CVD) and cholesterol in African     Americans adults with diabetes by addressing the modifiable risk factors of systolic blood     pressure (SBP), glycosylated hemoglobin (Hb A1c), and low-density lipoprotein cholesterol     (LDL-C). We will evaluate the impact of a tailored CVD risk management intervention     administered by nurses via the telephone. The intervention incorporates medication management     and behavioral modification and will be tailored to the needs of vulnerable high risk     subjects (e.g. African Americans, low socioeconomic status, low literate). It will be     integrated into community clinics, thereby enhancing the potential for benefit and     generalizability to other settings.      The primary hypothesis is that among African American subjects with diabetes, a nurse     administered, tailored cardiovascular risk management intervention targeting both medication     management and behavioral patient self-management will decrease SBP by 5 mmHg, Hb A1c by     0.5%, and LDL-C by 20 mg/dl over 12 months relative to the cardiovascular education-only     control group.   "
226354|NCT00815815|"     This study will examine the effectiveness of inpatient treatment for anorexia nervosa versus     a sequenced treatment that transitions from higher intensity inpatient care to lower     intensity outpatient care.   "
226355|NCT00815828|"     The object of this study is to evaluate patients with a diagnosis of GD who are included in a     program of RE carried out with rubber tubes, comparing the frequency of women who will use     insulin in the group who will participate in the program with the group that won't do the     exercises, and to verify the impact of the program on the adequacy of capillary glycemic     control of the pregnant women.   "
226356|NCT00815841|"     Background: There is a paucity of data as to the effect of methylphenidate (MPH) on young     adults who do not have attention deficit hyperactivity disorder (ADHD). The existing data is     equivocal and focuses on neuropsychological functions that are not always relevant to the     clinical aspects of attention. Objective: To determine the effect of MPH on a diagnostic     continuous performance task that assesses attention per se (TOVA) and on a decision making     test (Modified Gamble Decision Test) in young, healthy adults. Methods: Fifty young adults,     men and women ages 20-30, without ADHD, learning disabilities, history of past or present use     of MPH or other psychotropic drugs, will be eligible to participate. Design: The experiment     will be conducted in 2 sessions, the first lasting 3.5 hours and the second 2.5 hours in a     randomized, double-blind prospective design. In the first session, the subjects will be     screened for ADHD past and present, major psychiatric diagnosis (depression, anxiety, etc),     use of MPH in the past, psychotropic medications or recreational drugs and any other chronic     illness; urine will be tested for beta-hCG to rule out pregnancy. Blood pressure and heart     rate will be measured. The participants will then be given either placebo or MPH (15-20 mg)     and after 90 minutes will proceed to complete the TOVA (that lasts 22 minutes) and Modified     Gamble-Decision Test (15 minutes). Before taking the pill and prior to the testing, the     subjects will complete the Visual Analogue Scale (VAS) which quantifies their subjective     feelings regarding present mental and emotional state. In the second session, 2 weeks later,     blood pressure and heart will be measured and the VAS completed prior to and 90 minutes after     taking the tablet. The subjects then undergo the TOVA and Modified Gamble-Decision Test. Data     Analysis: will be performed using the paired t-tests for parametric variables and one way     ANOVA with repeated measurements. Significance: Results of this study are important since MPH     is used and abused by healthy students as a study aid although its objective effects in     normal young adults are not well delineated   "
226357|NCT00815854|"     This study will examine possible causes of metabolic side effects in people taking atypical     antipsychotic (AAP) medications.   "
226358|NCT00815867|"     Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular     filtration rate estimated 30 days after kidney transplant.   "
226359|NCT00815880|"     The C-Pulse Feasibility Study is evaluating the safety and performance of a new product for     the treatment of heart failure. The product is designed to help reduce the symptoms of heart     failure and help patients function better with daily activities. The study evaluates multiple     measures of heart function and whether the patient's quality of life has been improved since     the device implant. The patient will have several visits after the device implant to assess     how well they are doing and to monitor any safety concerns.   "
226360|NCT00815893|"     The objective of this study is to evaluate the feasibility of dexmedetomidine infusion for     oral cancer patients undergoing awake fiberoptic nasal intubation. We hypothesized that a     loading dose of intravenous dexmedetomidine before awake fiberoptic nasal intubation for oral     cancer patients undergoing general anesthesia will provide adequate sedation and analgesia     without respiratory depression and upper airway obstruction.   "
226361|NCT00815906|"     The purpose of this study is to evaluate the safety and tolerability of single doses of     SBI-087 in Japanese subjects with rheumatoid arthritis.   "
226362|NCT00815919|"     The purpose of this research study is to determine the effectiveness of bortezomib (Velcade)     plus prednisone for treating chronic graft versus host disease (cGVHD) and the safety of this     drug combination in this patient population. Chronic GVHD is a medical condition that may     occur after allogeneic stem cell transplantation. The donor's immune system may recognize the     participants body (the host) as foreign and attempt to reject it. Bortezomib has been used     in other research studies, and information from those studies suggests that this drug may     help to control the abnormal immune responses that underlie cGVHD.   "
226363|NCT00815932|"     This is a controlled trial designed to determine short- and long-term effects of repeated     tDCS on the P300 component of event-related evoked potentials in patients with chronic     neuropathic pain due to Complex regional Pain Syndrome (CRPS) or diabetic neuropathy as     compared with healthy subjects.   "
226421|NCT00816686|"     This is a first in human study of AGS-16M18 given every week to subjects with advanced renal     cell cancer. AGS-16M18 will be administered as a 60 minute IV infusion on consecutive days     until the disease worsens.   "
226422|NCT00816699|"     Proportion of patients in study group(preprint preoperative anesthetic risk should have more     anxiety, more knowledge, and more cancellation than controlled group   "
226423|NCT00816712|"     This is a study to evaluate the use of fractional synthetic rate as an early biomarker of     muscle anabolism (muscle build-up).   "
226424|NCT00816725|"     The original trial will evaluate the effectiveness of a Web-based program in preventing     postpartum depression. The site has been modified to provide materials from both conditions.   "
226364|NCT00815945|"     Uterine sarcomas account for less than 5% of all carcinomas of the uterine corpus. The     prognosis of these patients is extremely limited. Recurrence rates of 50-60% are reported     even for early-stage disease (FIGO I/II). Median overall survival is below 12 months in     patients with advanced or metastatic disease.      Ovarian carcinosarcoma is extremely rare among ovarian malignancies (< 2%). That is why there     is insufficient data as a basis for establishing a gold standard. As a result, these cases     tend to be treated in the same way as uterine sarcomas or epithelial ovarian malignancies in     clinical practice.      On the basis of data published to date on the treatment of mixed mesenchymal-epithelial     tumors, it is clear that the treatments commonly used to date have limited activity while     producing clinically relevant toxicity. The regimes verified so far (Cisplatin / Ifosfamide,     Ifosfamide/Paclitaxel and Gemcitabine/Docetaxel) exhibit a considerable side effect spectrum     and are only rarely feasible on clinical everyday life conditions, so e. g. the rate of     withdrawals due to toxicity was in a study collective of selected females treated with the     last combination at 40 %. The physician has to check in every individual case if one of the     above mentioned combinations is feasible. The search for alternative effective and better     tolerated treatment options is essential. The toxicity data on the carboplatin-PLD     combination are known, and efficacy has been identified in small cohorts.      The objective of this study is to explore the efficacy of combination PLD-carboplatin     treatment in a larger patient population.   "
226818|NCT00814879|"     This pilot study will provide data on the safety and efficacy of the combination of     Raltegravir (RAL) 400mg BID + Atazanavir (ATV) 300 mg BID in Antiretroviral (ARV)-experienced     subjects that have a suppressed HIV viral load on a Ritonavir (RTV) boosted Protease     Inhibitor (PI) based regimen who are then switched to a regimen of RAL 400mg BID +ATV 300mg     BID.   "
226365|NCT00815958|"     The embolisation of fat and bone marrow during long bone instrumentation is a well-known     complication of major joint replacement surgery. Clinically significant venous thromboembolic     disease, cardiopulmonary dysfunction,cerebral emboli, and death have all been described.     Because the intravasation of medullary contents is caused by increased pressure during canal     instrumentation, the use of the Synthes RIA (Reamer-Irrigator-Aspirator), a negative     pressure-irrigated high-speed reamer, may result in a lower incidence of embolism.      This controlled clinical trial will evaluate the utility of the RIA in reducing the frequency     and severity of embolic events as detected by intraoperative transesophageal echocardiography     (TEE) and transcranial Doppler (TCD) during total knee arthroplasty (TKA) surgery.   "
226366|NCT00815971|"     Recently it has been suggested that specific mutations in the EGFR gene in lung cancer     patients is associated with response to a novel drug targeting the EGF system. Recent     research also indicates that there is a possible association to the degree of aggressiveness     of the disease.      The importance of these mutations is controversial, because the data are based on small     studies with highly selected patients.      In this project the investigators want to study the types and frequencies of EGFR mutations     in both untreated and treated patients in a systematic manner and relate this to survival.      The thorough registration of patient data in DK enables us to create a strong The     investigators expect this knowledge to be of greatest importance for future rational use of     drugs targeting the EGF receptors.   "
226367|NCT00815984|"     In about 800 children with allergic diseases (asthma, allergic rhinitis, atopic dermatitis)     the investigators will retrospectively and cross-sectionally analyze the     influence/correlation of diagnosis, treatment methods, allergy status (skin prick test     results), lung function tests results on/with the concentration of nitric oxide in exhaled     breath.   "
226368|NCT00815997|"     To investigate the advantage of using a 4Fr guiding catheter over a 6 Fr, frequencies of     radial artery occlusion after transradial coronary intervention (TRI) will be evaluated.     Radial artery occlusion rate in 4 Fr TRI group is expected to be not more than that in 6Fr     groups.   "
226369|NCT00816010|"     Hypothesis To investigate whether telephone counselling by nurse educator between clinic     visits with particular emphasis on adherence to medications and lifestyle modification in     patients with coronary heart disease and diabetes will reduce mortality and hospitalisation     rates due to cardiovascular events compared to usual clinic-based care.   "
226370|NCT00816023|"     The purpose of this study is to assess the efficacy and identify the optimal dose(s) of     ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery     including the use of cardio pulmonary bypass.   "
226371|NCT00816036|"     The primary objective of this study is to determine whether a nurse-initiated intervention,     which couples brief inpatient counseling and proactive telephone counseling by a centralized     tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers. If proven     effective, the proposed intervention will provide a practical strategy to enhance the     adoption and implementation of recommended smoking cessation procedures in VA hospitals, and     will demonstrate the utility of quitlines in preventing relapse in hospitalized smokers once     they leave the hospital.   "
226372|NCT00816049|"     The purpose of this study is to increase the fraction of patients, who become MRD-negative     during consolidation for the non-HR ALL group through individualized intensification of the     6MP-dosage days 30-85.   "
226373|NCT00816062|"     The purpose of this study is to examine, through the endpoints established in this protocol,     the long-term safety and effectiveness of the Talent Abdominal Stent Graft System, in a     post-approval environment.   "
226374|NCT00816075|"     The purpose of this study is to compare and evaluate the efficacy of distilled water vs     Mitomycin C on preventing the recurrences of intermediate risk group recurrent superficial     bladder cancer administered as a single dose immediate instillation after complete     Transurethral Resection(TUR) of the tumor.   "
226375|NCT00816088|"     Fungal infections caused by Aspergillus fumigatus are now identified in up to 45% of patients     dying from haematological malignancy. There has been a significant increase in deaths from IA     over the last 20 years. Our current diagnostic approach is neither sensitive nor specific.     The purpose of this study is to prospectively assess the value of current diagnostic tools,     as well as test other new diagnostic methods for the diagnosis of IA among haemato-oncology     patients undergoing chemotherapy or stem cell transplantation.   "
226376|NCT00816101|"     The purpose of this pilot clinical study is to compare healing rates, pain levels, and     incidence of wound complications including infection with the use of a moist PROCELLERA™     Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite,     following curettage and electrodesiccation of skin lesions.   "
226425|NCT00816738|"     To evaluate the clinical outcomes in patients with recurrent corneal erosions who received     anterior stromal puncture by use of neodymium:yttrium-aluminum-garnet (Nd:YAG) laser.   "
226377|NCT00816114|"     In this study investigators propose to do a chart review of all Chronic Myelogenous Leukemia     (CML) patients that are treated outside of a clinical trial with imatinib that come to MDACC     for a second opinion. This is an important population of patients that differs in their     management from patients treated in clinical trials for several reasons including but not     limited to:        1. It represents a very large patient population receiving standard-dose therapy with          imatinib. Estimate over 200 patients evaluated and fall in this category.        2. The follow-up for patients in the largest trial using standard-dose imatinib (the IRIS          trial, with 553 patients in treated with imatinib) has been limited after the first 12          months. For example, the rate of molecular responses after the first 12 months of          therapy was not obtained as samples stopped being collected at that time point.        3. Patients who are or become pregnant during therapy with imatinib have not been eligible          for clinical trials with imatinib or had to be taken off study. Thus, there is no          information on the effect of imatinib on imatinib on pregnancy and conception, several          such patients have been followed at MDACC.        4. This is a patient population that follows therapy mostly as directed by their local          oncologists. This is frequently less stringently adhered to the recommended guidelines          for imatinib therapy, with more frequent treatment interruptions, and frequently using          suboptimal doses of imatinib (i.e., less than 300mg daily). The effect of these          treatment interruptions and suboptimal dosing on response and development of resistance          is unclear.      Investigators thus plan to conduct a chart review of these patients to study their treatment     course before their initial evaluation at MDACC, and between and during visits to MDACC.   "
226378|NCT00816127|"     The purpose of this study is to investigate how effective and cost saving     1-deamino-8-D-arginine vasopressin (desmopressin, DDAVP) is as opposed to the transfusion of     blood products in preventing bleeding after teeth extraction in persons with severe liver     disease being evaluated for liver transplant.   "
244510|NCT01055847|"     This is multicenter placebo-controlled study evaluating the safety and efficacy of AI at two     dosage levels compared to placebo in CF patients with P. aeruginosa lung infection.   "
226379|NCT00816140|"     Clarithromycin-based triple therapy containing a proton-pump inhibitor (PPI) twice daily,     amoxicillin 1g twice daily, and clarithromycin 500 mg twice daily for 7 days is one of the     standard firs-line therapy for Helicobacter pylori eradication. However, because of     unsatisfactory eradication rate (80-85%), the Maastricht III guideline recommended extending     the treatment duration to increase the eradication rate. Recently, levofloxacin (500 mg     qd)-based triple therapy has been shown to achieve an eradication rate of 90% for both the     first- and second-line treatment for H. pylori eradication. Several studies have demonstrated     that high dose (750mg) and short-course (5 days) levofloxacin is as effective and well     tolerated as traditional dose (500mg) and course (10 days) for treatment of mild-to-severe     community acquired pneumonia. The high dose and short-course therapy has the potential to     increase patient compliance and reduce bacterial resistance to fluoroquinolones. However,     whether increasing the dosage of levofloxacin from 500mg to 750 mg qd can augment the     efficacy of triple therapy in eradication of H. pylori and shorten the duration of therapy     remains unknown. Although levofloxacin-based regimen was presumed to be more effective,     previous reports pointed the concern that resistance to fluoroquinolone and other antibiotics     which susceptible to the pumping efflux of bacteriae would increase among the gut flora.   "
226380|NCT00816153|"     Pleth Variability Index (PVI) seems to be an ideal parameter to guide fluid management:     dynamic parameter and non-invasive. PVI could guide fluid management during surgery and     optimization of the plethysmographic-derived parameter could improve hemodynamics of the     patients.   "
226381|NCT00816166|"     The main objective of this study is to prospectively evaluate the safety, probable benefit,     and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter,     randomized clinical trial.      A secondary objective of this study is to evaluate the impact of stenting in the     neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of     stay, charges, and costs.   "
226382|NCT00816179|"     This study is being done to find out if an endoscope passed down the throat, through the     stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the     abdomen and take biopsies if needed.   "
226383|NCT00816192|"     There is no study comparing safety/efficacy of externally vs internally cooled tip catheters     in patients undergoing ablation for paroxysmal atrial fibrillation (pAF).      The primary objective is to compare safety and efficacy of externally irrigated-tip catheter     versus internally irrigated-tip catheter in achieving long term electrical isolation (EI) of     pulmonary veins (PV) in paroxysmalatrial fibrillation (pAF).   "
226384|NCT00816205|"     This is an open label, dose-finding study. Approximately 8 healthy subjects will be     participating in this study.      Within one week after the screening visit, subjects who meet all inclusion criteria and none     of the exclusion criteria will enter a one day treatment period. During this period, 4 anal     manometric studies will take place. Study medication (Coated Nifedipine suppositories at     various doses) will be administered at pre-determined intervals. During the study, blood     samples will be obtained for plasma Nifedipine analysis.   "
226385|NCT00816218|"     This project is designed to evaluate the molecular mechanisms involved in the early     development of endothelial dysfunction in type 2 diabetic patients. The investigators intend     to correlate increases in insulin signaling pathway activity following pioglitazone therapy     with improvements in nitric oxide synthase expression in skeletal muscle. In addition, the     investigators will evaluate vascular responses and in vivo nitric oxide release during     administration of acetylcholine and nitroprusside in patients with type 2 diabetes. Enhanced     knowledge of the molecular mechanisms responsible for endothelial dysfunction, an early     abnormality in the pathogenesis of atherosclerosis, is critical before novel therapies to     arrest or delay the appearance of cardiovascular complications in diabetes can be developed.      The investigators intend to recruit fifty type 2 diabetic patients treated with diet alone or     diet plus sulfonylureas or meglitinides and add Pioglitazone (45 mg), an insulin sensitizer,     for 6 months. In addition to assessment of clinical and metabolic parameters, insulin     sensitivity and brachial artery and skin microcirculatory responses to acetylcholine and     nitroprusside in combination with simultaneous determination of nitric oxide release will be     documented before, 3 and 6 months after Pioglitazone therapy is initiated. Circulating levels     of markers of endothelial damage (VCAM, ICAM, selectins), inflammation (C-reactive protein     and interleukins), increased coagulability (PAI-1) as well as lipids and apolipoproteins will     measured during the study. Skeletal muscle biopsies will be performed during the euglycemic     insulin clamp before and 6 months after therapy for measurements of NO synthase activity and     key elements of the insulin signal transduction pathway involved in the regulation of glucose     metabolism (IRS-1, PI-3 kinase, PI-3 kinase associated with IRS-1 and the mitogenesis     MAP-kinase.      Type 2 diabetes confers a substantial increase in the risk of cardiovascular disease. This is     believed to be due, in part, to endothelial dysfunction, which correlates closely with     impaired vascular responsiveness. Our study will clarify further the extent to which     resistance to insulin action and impaired nitric oxide release from endothelial cells are     interrelated. We also expect to demonstrate that insulin sensitizers (pioglitazone) can help     to restore normal endothelial function, and ultimately prevent/delay the appearance of     vascular disease in patients with type 2 diabetes.   "
226386|NCT00816231|"     The purpose of this study is to determine how people react to different combinations of     alcohol and nicotine.   "
226387|NCT00816244|"     The purpose of this study is to monitor:        -  Tumor biological alterations following two weeks of neo-adjuvant statin therapy.        -  Effects of statins on tumor proliferation.        -  Functional studies on the mevalonate pathway.   "
226426|NCT00816751|"     The aim of this study is to estimate the efficacy of intracervical versus paracervical block     on pain experienced during first trimester suction curettage without the use of preoperative     cervical ripening. Because of the theoretical improved reliability of stromal block, the     investigators hypothesize that intracervical block would produce lower pain scores than     paracervical block at the time of cervical dilation.   "
226388|NCT00816257|"     All patients enrolled in the registry will be recipients of single and double lung     transplantation (bilateral sequential, heart-lung, or living related donor grafts). During     the routine management of lung recipients frequent surveillance of the lung allograft is     necessary. This routinely involves: measurement of pulmonary functions, chest radiography,     collection of peripheral blood to assess other organ function and monitor therapeutic drug     levels, and bronchoscopic evaluation allowing for collection of lung lavage fluid and lung     tissue biopsy. This surveillance normally follows a set schedule during the first one to two     years following the transplant procedure. Surveillance is routinely performed at weeks 2, 8,     12, 24, 36, and 52 during the first year following the transplant procedure. Additional     surveillance may be performed at any time when clinically indicated for the optimal     management of the recipient. Information and specimens collected from each of these     encounters will be entered in the data registry and specimen repository.   "
226389|NCT00816270|"     The aim of this randomized and masked prospective trial is to compare the effectiveness of     Liquid Bandage (Octyl-2-Cyanoacrylate) and 6/0 nylon suture as a wound closure device in     upper lid blepharoplasty surgery.   "
226390|NCT00816283|"     RATIONALE: Dasatinib and vorinostat may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Giving dasatinib together with vorinostat may kill more     cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib when     given together with vorinostat in treating patients with accelerated phase or blastic phase     chronic myelogenous leukemia or acute lymphoblastic leukemia.   "
226391|NCT00816296|"     The goal of this study is to investigate comparisons between the intestinal microbiome in     patients with obesity and in patients with obesity and Non-Alcoholic Fatty Liver Disease     (NAFLD). With this protocol we hope to better understand how the microbiome of each     individual works with disease progression.   "
226392|NCT00816309|"     Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent     chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is     thought to improve cough and help clear the airways of sticky sputum. Traditionally,     physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece,     called the Acapella device) has been developed to make physiotherapy practise easier. This     study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients     with severe bronchiectasis.   "
226393|NCT00816322|"     The whole study was divided into two major parts: (A) the 12-week, double-blind, randomized     controlled, parallel omega-3 fatty acid monotherapy study in 60 patients with mild to     moderate major depressive disorder. (B) The double-blind, randomized controlled, parallel     omega-3 fatty acid add-on prevention study in 60 patients with major depressive disorder in     recovery status.      The goals of this study were to examine the therapeutic and recurrence prevention effects of     omega-3 fatty acids on major depressive disorder.   "
226394|NCT00816335|"     The purpose of this pilot study is to evaluate a combined and integrated technological     approach of 18F-FDG-directed perioperative PET/CT imaging and intraoperative handheld gamma     probe detection of known and occult disease in patients undergoing surgery for solid     malignancies.   "
226395|NCT00816348|"     This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to     infants and children with parenteral nutrition-associated liver disease to enable reversal of     elevated serum liver enzymes and direct bilirubin (cholestasis).   "
226396|NCT00816361|"     Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors     refractory to standard therapy or for which no standard therapy exists.   "
226397|NCT00816374|"     The purpose of the investigators' study is to find the best way to provide information about     sun protection and skin cancer detection. The investigators want to see which of two methods     most improves sun protection and screening attitudes and practices. The investigators hope to     improve these attitudes and practices among people who are at higher risk for melanoma.     People at higher risk for melanoma are first degree relatives (mother, father, sibling or     child) of people diagnosed with melanoma.   "
226398|NCT00816387|"     The purpose of this study is to evaluate the efficacy of fallopian sperm perfusion (FSP) in     comparison with standard intrauterine insemination (IUI) in natural cycle for couples with     unexplained infertility or mild male factor.   "
226399|NCT00816400|"     Evaluate the safety, tolerability and the tolerated maximum dose of MEDI-575 in adult     subjects with advanced solid tumors refractory to standard therapy or for which no standard     therapy exists.   "
226400|NCT00816413|"     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor     peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop     the patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Removing the T cells from the donor cells     before transplant and giving cyclosporine and mycophenolate mofetil after transplant may stop     this from happening.      PURPOSE: This phase I/II trial is studying the side effects of giving a donor stem cell     transplant after pentostatin and total-body irradiation and to see how well it works in     treating patients with hematological cancer.   "
226427|NCT00816764|"     This is the first in human study of AGS-8M4 given every 2 weeks to subjects with advanced     ovarian cancer. AGS-8M4 will be administered as an IV infusion until the disease worsens.   "
226428|NCT00816777|"     The primary objective of this study is to evaluate the safety and efficacy of Irinotecan Bead     in combination with intravenous chemotherapy versus intravenous chemotherapy alone in the     treatment of unresectable liver metastases in patients with colorectal cancer. The results of     this study are intended to be used in support of a PMA application for a combination device   "
226429|NCT00816790|"     The objective of this study is to determine the feasibility of conducting a large scale     randomized controlled trial comparing standard and renally adjusted dosage of antibiotics in     the septic shock patients with acute renal dysfunction. We will use Piperacillin as the     prototype antibiotic in our study.   "
229612|NCT00858208|"     Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular     degeneration in routine clinical practice at least as good as demonstrated in randomized     multicenter clinical trials.   "
226433|NCT00816842|"     Citrulline is an amino acid produced in the intestine and in the liver, but the liver does     not contribute significantly to circulating citrulline concentrations. The intestine is thus     the only organ that normally releases significant amounts of citrulline into the blood     stream. The investigators have designed a study looking at the value of measuring plasma     citrulline concentration in patients with tropical enteropathy of mixed HIV status. The focus     will be on the ability of the intestine to sustain the individual concerned from a     nutritional standpoint. The investigators hypothesise that plasma citrulline concentration is     a marker of small bowel absorptive integrity and an appropriate surrogate for HIV related     enteropathy.   "
226434|NCT00816855|"     The primary objective of this study is to determine the tolerance and overall survival in     patients with stage Ⅲ NPC treated with neoadjuvant chemotherapy and concurrent     chemoradiation.      Secondary objectives of the study are to evaluate the distant metastases free survival, and     disease-free survival of patients with stage Ⅲ treated with this regimen.   "
226401|NCT00816426|"     This study, conducted jointly by researchers at the National Masan TB Hospital, Asan and     Samsung Medical Centers in Seoul, Republic of Korea, and the Yonsei University and the NIH in     the United States, will examine why some patients with tuberculosis (TB) develop disease that     is harder to treat than most cases. TB is an infection of the lung that usually can be     successfully treated with anti-TB drugs. However, some people get a more serious kind of     disease (called multi-drug resistant TB or extensively drug-resistant TB) that is very     difficult to treat and may not be cured by the regular medicines available. This study will     try to find out if some of the common TB drugs are getting to the place where the TB bacteria     are. It will also look at how current anti-TB drugs might be used more effectively and how     better drugs might be developed.      People 20 years of age and older with hard-to-treat TB who have elected to undergo surgical     removal of part of their lung at the National Masan Tuberculosis Hospital, Masan, the Asan     Medical Center, and the Samsung Medical Center, may be eligible for this study.      Participants undergo the following procedures:        -  Medical history and physical examination, including sputum sample.        -  Blood tests at various times during the study.        -  Drug administration. Subjects are given one dose each of five common TB drugs          rifampicin, isoniazid, pyrazinamide, kanamycin and moxifloxacin before they undergo          surgery to remove part of their lung. After surgery, some of the lung tissue and fluid          around the lungs that was removed during surgery will be examined to determine the          regions where the TB bacteria live and analyze the lung tissue itself.        -  Dynamic MRI (magnetic resonance imaging) scan. This type of scan uses a magnetic field          and radio waves to produce pictures of the lung. Subjects lie very still on a table          inside the cylindrical scanner with their head on a soft cradle and their hands over          their head. Several images are obtained for less than 5 minutes at a time.   "
226402|NCT00816439|"     The cannabinoid type 1 (CB1) receptor is a protein found in the brain that is involved with     the effects of marijuana; it may also play a role in the effects of alcohol dependence and     withdrawal. Earlier animal studies have shown that although long-term alcohol use decreases     the number of CB1 receptors in the brain, the number returns to normal after alcohol use     stops. This study will use positron emission tomography (PET) and magnetic resonance imaging     (MRI) scans to trace a radioactive chemical called [11C]MePPEP, which can locate and measure     the number of CB1 receptors in the brain. Researchers will study the CB1 receptors in the     brains of people with alcohol dependence, and compare the results to the CB1 receptors in the     brains of people without alcohol dependence. The results of this study will be used to     further research into appropriate treatment procedures for alcohol dependence.      This study will include 30 men with alcohol dependence and 50 men without alcohol dependence.     All of the men must be between 18 and 65 years of age. Participants in both groups must not     have any medical conditions that will prevent them from undergoing PET or MRI scans.      For the PET scan, participants will be injected with a small amount of [11C]MePPEP and will     then be brought to the PET scanner. The scan will take between 3 and 4 hours, but     participants will be allowed to take breaks over the course of the scan. The MRI scan will     not require any injections and will take approximately 1 hour to complete.      Participants without alcohol dependence will make three visits to the National Institutes of     Health Clinical Center. Blood and urine samples will be taken during one visit, and     participants will arrange to have an MRI scan on one visit and a PET scan on the other visit,     in whichever order they prefer.      Participants with alcohol dependence will undergo two PET scans: the first will be performed     between 3 and 7 days after the participant last consumed alcohol, and the second will be     performed approximately 2 to 4 weeks after the first scan (with no alcohol consumption     permitted in the interval). Participants will alcohol dependence will also undergo an MRI     scan and will provide blood and urine samples.   "
226403|NCT00816452|"     Patients with prostate cancer treated in outpatient clinics will be recruited by their     urologist physician.      Primary Objective: To evaluate the compliance in male patients with prostate cancer treated     with Bisphosphonate and that suffered from Osteopenia/osteoporosis.      Secondary objectives:      To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon     recommendation by Urologists.      To evaluate the overall number of patients treated by Bisphosphonate in the out-patient     clinics, To evaluate incidence of osteopenia/osteoporosis in this study population.   "
226404|NCT00816465|"     This clinical study is designed to evaluate the safety of oral administration of the medical     food Hoodia to patients with non alcoholic fatty liver disease.      Oral administration of Hoodia is common in many western world countries for appetite     suppression and as a food supplement or medical food used for dietary purposes.      Nonalcoholic steatohepatitis or NASH is a common, often silent liver disease which affects     about 2%-5% of Americans. NASH is strongly associated with the metabolic syndrome, diabetes     type-2 and obesity and can lead to cirrhosis, HCC, liver transplantation or death.This     clinical trial has been designed to assess the safety of short term oral administration of     Hoodia to patients with NASH.   "
226405|NCT00816478|"     This study is a proof-of-concept clinical study designed to test the hypothesis that oral     administration of galactose can lower the level of a circulating factor that increases     glomerular permeability to albumin in patients with resistant FSGS.   "
226406|NCT00816491|"     The primary endpoint of the study will be to compare the accuracy of two procedures (FICE     with target biopsies only, versus conventional white light colonoscopy with recommended     targeted and random biopsies) in the endoscopic surveillance of patient with long-standing     UC. Accuracy will be measured based on the number of patients with confirmed neoplasia using     each technique. The combined histological outcome following the two procedures will represent     the gold-standard diagnosis for each patient. Secondary outcomes will be the number of     patients with false-positive findings, the number of neoplastic lesions detected, the number     of false-positive lesions per patient for each technique and the total time required for each     procedure.   "
226407|NCT00816504|"     This study is a proof-of-concept clinical study designed to test the hypothesis that oral     administration of galactose can lower the level of a circulating factor that increases     glomerular permeability to albumin in patients with resistant FSGS.   "
226408|NCT00816517|"     Psoriasis vulgaris is a chronic disease in which psoriatic plaques may appear on the knees,     elbows, scalp and trunk. Evidence suggests the role of neurogenic inflammation in the     pathogenesis of psoriasis. Botulinum toxin has been shown to have an effect on inhibiting     neurogenic inflammation.      Recently, it was reported that patients who suffered from dystonia and had concomitant     psoriasis, when treated with botulinum toxin for dystonia noted a dramatic improvement of     their psoriatic lesions.      This pilot study will determine the safety and efficacy of botulinum toxin in the management     of psoriasis vulgaris.   "
226430|NCT00816803|"     This study is designed to assess the safety of autologous bone marrow derived cell transplant     in chronic spinal cord injury patients. The hypothesis is that the availability of bone     marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.   "
226431|NCT00816816|"     The primary objective of this study is to determine the tolerance and overall survival in     patients with stage ⅣAB NPC treated with neoadjuvant chemotherapy and concurrent     chemoradiation.      Secondary objectives of the study are to evaluate the distant metastases free survival, and     disease-free survival of patients with stage ⅣAB treated with this regimen   "
226432|NCT00816829|"     Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological     changes associated with sleep apnea syndrome.   "
226522|NCT00810940|"     This is a randomized, controlled clinical trial at three sites to determine the safety and     preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is     hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient     may have improved neurological function following treatment.   "
226409|NCT00816530|"     Hypothesis: A higher sensitivity to breast cancer detection can be achieved in women with     dense breast tissue by performing and reviewing results of Automated Breast Ultrasound (ABUS)     and Digital X-Ray Mammography (XRM) together as part of routine screening compared to     performing and reviewing results of XRM alone.      Primary Objective: For the cohort of asymptomatic women who have dense breast tissue,     calculate the sensitivity of Digital X-Ray Mammography (XRM) and ABUS together as a breast     cancer screening modality and compare it to that of XRM alone.      Secondary Objective: For the cohort of asymptomatic women who have dense breast tissue,     evaluate the specificity of XRM and ABUS together compared to that of XRM alone; Calculate     the negative predictive value (NPV) and positive predictive value (PPV) for XRM and ABUS.      Endpoint: Breast cancers detected by radiologists in the clinical screening setting and     confirmed by pathology.      Study Design: This is a prospective matched-pair clinical study enrolling more than 20,000     women with parenchymal density > 50% on digital x-ray mammography (XRM). Participants will     receive ABUS as an adjunct to XRM. Any abnormal findings, from either XRM or ABUS, will     receive appropriate management action consistent with accepted medical standards of care. All     evaluation results, diagnosis and treatment outcomes will be recorded. Participants will be     followed for one year and those who are not diagnosed with breast cancer at enrollment or     during the follow-up interval must undergo an annual mammogram at study completion, the     outcome of which will be recorded.   "
226410|NCT00816543|"     The primary objective of this trial is:        -  To determine whether it is feasible in locally advanced gastric or gastroesophageal          cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme          and also to determine what toxicities are involved.      The secondary objective of this trial are to describe:        -  The disease free survival at one and two years in that subgroup of patients that has          undergone a R0 resection.        -  The downstaging after 3 cycles of chemotherapy, pCR in that subgroup of patients that          have undergone an R0 resection and progression-free survival and overall survival at one          and two years.   "
226411|NCT00816556|"     Atrophic vaginitis is a common problem that occurs in up to 40% of postmenopausal women. The     main symptoms are dryness, itching and burning in and around the vagina. These symptoms in     turn can cause pain with intercourse. Other symptoms can include urinary frequency and     urinary urgency. These symptoms are caused by the decreasing levels of estrogens in     postmenopausal women.      The current treatment options include hormone replacement therapy by mouth and patch and     vaginal creams, tablets and rings. The current guideline recommend using hormone therapy at     the lowest dose for the shortest time. We are trying to find the lowest effective dose of     estrogen cream that helps with symptoms without causing an increase in estrogens in the blood     stream.      We want to compare two estrogen creams, estradiol and estriol, each at very low doses, with a     placebo cream. Estradiol cream is available on prescription but we want to see how effective     it is at one tenth the commonly prescribed dose. Estriol cream is not commonly prescribed and     is only available at compounding pharmacies. We want to see if either of these estrogens is     effective at one tenth the usual dose. We also want to see if these creams are effective when     massaged onto the outer part of the vagina, rather than the usual method of treatment, which     is inserting them into the vagina.   "
226412|NCT00816569|"     To investigate a possible benefit of Orthokeratology contact lenses to improve uncorrected     visual acuity of keratoconus patients   "
226413|NCT00816582|"     Purpose:      To determine whether [18F]FES can predict clinical benefit (defined as complete response,     partial response and stable disease ≥ 6 months) to fulvestrant (250 mg IM q 28 days) in     post-menopausal women with recurrent or metastatic ER+ breast cancer who are candidates for     further hormonal therapy.   "
226414|NCT00816595|"     RATIONALE: Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.     Others find cancer cells and help kill them or carry cancer-killing substances to them. It is     not yet known whether giving pentostatin and cyclophosphamide together with rituximab is more     effective with or without bevacizumab in treating patients with B-cell chronic lymphocytic     leukemia or small lymphocytic lymphoma.      PURPOSE: This randomized phase II trial is studying the side effects of giving pentostatin     and cyclophosphamide together with rituximab with or without bevacizumab and to see how well     it works in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic     lymphoma.   "
226415|NCT00816608|"     Hypothesis : The maximum body weight in lifetime is associated with the onset of development     of type 2 diabetes.   "
226416|NCT00816621|"     This study will test the effectiveness of a parent training program aimed at helping children     who are adopted internationally to develop secure, organized attachments to their parents.   "
226417|NCT00816634|"     Until today, the 5-FU/cisplatin combination is the reference regimen with 30-45% response     rates, which is most commonly used to treat patients with metastatic, recurrent or locally     advanced, unresectable squamous cell carcinoma of the esophagus. Because the classical dose     schedule of this two-drug combination is cisplatin 100 mg/m2 day 1 and 5-FU 1000 mg/m2/day     continuous infusion for 96-120 hr, prolonged administration time and mucosal toxicity are     inconvenient to the patients with the aim of palliation. Capecitabine, which is oral prodrug     of 5-FU and mimic continuously-infused 5-FU, is being investigated in phase I, II and III     trials for the treatment of gastric, gastroesophageal, and esophageal cancers, primarily in     the first-line metastatic setting. In our experience, capecitabine plus cisplatin combination     (XP) as a first-line treatment for 45 patients with advanced or recurrent esophageal squamous     cell carcinoma demonstrated a promising anti-tumor activity with 57% of response rate and     showed tolerable toxicity with convenience.      Paclitaxel has been also investigated as monotherapy and in combination with cisplatin in     patients with advanced esophageal cancer. A Dutch phase II study demonstrated that paclitaxel     combination with carboplatin had shown an encouraging confirmed response rate of 59% with 51     patients with resectable esophageal cancer in neoadjuvant setting. Another Dutch phase II     study showed 43% of response rate including 4% of CR with 8 months of response duration when     paclitaxel plus cisplatin administration was given for patients with metastatic esophageal     cancer. Although recently first-line palliative chemotherapy regimen in esophageal cancer has     been investigated, many trials have failed to show superiority to 5-FU/cisplatin combination.     Since we considered that XP or XT is more effective and convenient chemotherapy regimen than     5-FU/cisplatin, this randomized phase II study was planned to compare XP with XT in terms of     efficacy and tolerability.   "
226418|NCT00816647|"     The operative management of chronic patellar instability has been controversial. Medial     patellofemoral ligament reconstruction has gained success recently and might be superior to     other soft-tissue procedures. The objective of this prospective study was to compare the     clinical outcome after medial patellofemoral ligament reconstruction compared with medial     reefing for chronic patellar instability.   "
226435|NCT00816868|"     Because of the effect in the treatment of NSCLC, the capecitabine and erlotinib may compose     to a new regimen for NSCLC. Based on the preclinical observation and the confirmed clinical     synergistic anti-tumor activity of combined capecitabine and erlotinib in gemzar refractory     advanced pancreatic cancer (APC), the investigators previously conducted a phase II study of     erlotinib in combination with capecitabine against NSCLC.   "
226436|NCT00816881|"     The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus     clearance devices.   "
226437|NCT00816894|"     A first generation of clinical studies, performed during the last decade, demonstrates that     adjuvant treatment with compounds that enhance NMDAR-mediated neurotransmission due to their     agonistic activity at the NMDAR-associated glycine (GLY) site (e.g. GLY, D-serine (DSR))     leads to significant symptom reductions in chronic schizophrenia patients.Furthermore,     preliminary findings suggest that treatment with NMDAR-GLY site modulators may also be     beneficial as antipsychotic monotherapy In the proposed project, during a three year period,     60 schizophrenia patients that fulfill treatment resistance criteria will be randomly entered     in a 10 week, two phase (fixed/flexible dose), parallel group, double blind controlled study     assessing the efficacy of olanzapine (OLA) (up to 40 mg/day) vs. DSR (up to 4000 mg/day) as     antipsychotic monotherapy.Clinical, neurocognitive, electrophysiological, and amino acids     (i.e. GLY, DSR) levels assessments will be performed during the study. The specific aims of     the proposed project are: 1) to assess the efficacy and safety of DSR as a new medication for     treatment refractory schizophrenia, and 2) to assess DSR effects in terms of relevant amino     acids serum levels, neurocognitive performance, and relevant brain electrophysiological     parameters. The overall importance of the proposed project consists of its potential to lay     the foundations for an innovative type of intervention for treatment resistant schizophrenia     patients.   "
226438|NCT00816907|"     This study will test the usefulness of the medication metformin in treating people with     schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic     medications.   "
226439|NCT00816920|"     Whether isolated distal DVT (IDDVT), DVT confined to the calf, should be looked for and     diagnosed to allow them to be treated with anticoagulants remains one of the still unsolved     issues in vascular medicine, especially because of the insufficient data on clinical risks of     untreated distal DVT. Management studies have shown that it is safe to withhold     anticoagulation in outpatients with suspected DVT if compression ultrasonography (CUS)     limited to the proximal deep veins yields normal results on presentation and on repeated     examination after 5 to 7 days. This strategy is based on the premise that IDDVT do not need     to be diagnosed and treated, what is necessary when they extend involving the proximal veins.     There is no general agreement, however, on the assumption that the non-extending IDDVT do not     need to be diagnosed and treated, and many authors recommend to perform a single CUS     examination extended to the distal deep veins. All the available studies have treated with     anticoagulants the diagnosed IDDVT and no adequate information is available on the risk of     IDDVT left untreated.      The present study, performed in outpatients with suspected leg DVT, aims at assessing the     clinical consequences of IDDVT diagnosed (by a complete US investigation) but not treated     because the results of this investigation remain blind to both the patient and the treating     doctor, whereas the diagnostic-therapeutic procedure remains the usual one, based on CUS     investigation limited to diagnose proximal DVT, to be repeated after 5-7 days (or earlier) to     exclude an extension to proximal veins of an IDDVT potentially present.   "
226440|NCT00816933|"     Appendicitis is the most common benign inflammatory disease that requires an operation.      Laparoscopic appendectomy using three trocar is generally performed, and reveals good     surgical outcomes incluing less pain, early recovey, cosmetic effect et al. However, with     using three trocar, there are some problems including pain around trocar insertion     sites(three portions), wound infecton and scar at trocar insertion sites. For these reasons,     more minimal invasive appendectomy is required, with development of laparoscopic     instrument,eventually one port sppectomy is developed. So, the investigators assess     post-operative Outcomes according to the Number of Trocar.   "
226441|NCT00816946|"     This study aims to provide evidence regarding the feasibility of integrating an enhanced     maternal and child care health education package into the existing curricula of the National     Program for Family Planning and Primary Health Care (LHW Program) and evaluating the     feasibility of scaling-up as well as the impact on birth outcomes, nutritional status,     morbidity patterns and overall survival patterns at the community level.   "
226442|NCT00816959|"     Objective:      The primary objective of the study is to evaluate the effect of R-mabHDI in patients with     late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma.      The hypothesis is that the combination of R-mabHDI with the standard ABVD therapy in patients     with late stage (Stage III and Stage IV) and recurrent stage Lymphocytic Predominant     Hodgkin's Lymphoma will have a favorable outcome on the response and progress free survival.     The study is also aimed at evaluating the safety of R-mabHDI .      The aim of the study is to test this hypothesis by evaluating the clinical outcome in 1200     patients receiving combination of R-mabHDI once a week for 8 weeks and ABVD therapy every     other week for 12 treatments.   "
226456|NCT00817141|"     Urinary catheter was placed during several days after colonic surgery. Nevertheless, it is     probably unnecessary after Fast-Track colonic surgery. No prospective data permit to confirm     it.   "
226443|NCT00816972|"     This was a 1-week study of desloratadine (DL) plus oxybutynin (OXY) at two dose levels in the     treatment of post-nasal drip in participants with seasonal allergic rhinitis. Participants     received either desloratadine twice a day, oxybutynin twice a day, desloratadine plus     lower-dose oxybutynin twice a day, desloratadine plus higher-dose oxybutynin twice a day, or     placebo for 7 days.   "
226444|NCT00816985|"     The purpose of this study is to determine if a less invasive procedure such as liposuction     can be used to effectively reduce arm lymphedema (swelling of the arm) resulting from breast     cancer treatment. The standard surgery involves the removal of large portions of skin and     tissue leaving a large scar. This less invasive procedure (liposuction) uses 3 to 4 tiny     puncture sites and a vacuum tube leaving minimal scars.   "
226987|NCT00824070|"     This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or     gatifloxacin in aqueous humor samples collected following topical instillation of the     associated formulation in subjects undergoing cataract surgery.   "
226445|NCT00816998|"     Hypothesis : Early active range of motion protocol after open reduction and internal fixation     of a distal radius fracture with a volar fixed angle locking plate results in earlier return     of functional motion, earlier return to work and improved functional outcomes compared     delayed mobilization.      Specific Aim:      To compare early range of motion versus delayed motion protocol in distal radius fractures     treated with open reduction and internal fixation with a volar fixed angle locking plate with     respect to time to fracture union, range of motion, functional outcome measures, return to     work and complications.   "
226446|NCT00817011|"     The Purpose of this study is to predict antidepressant response in advance using     pharmacogenomics and peripheral biological markers in depressed patients.   "
226447|NCT00817024|"     We conduct this clinical trial to determine the effects of Xuefu Zhuyu capsule (based on TCM     Zheng Hou theory) in helping recovery from coronary heart disease(CHD)after PCI and find     out whether this kind of effecacy is much better within patients administered with TCM     syndrome-based individualized medication.   "
226448|NCT00817037|"     Patients with chronic kidney disease (CKD) have higher blood pressures than the general     population. They also tend to have protein leaking into the urine (proteinuria). CKD, high     blood pressure and proteinuria independently and together increase the risk of developing     atherosclerosis (hardening) of the arteries that leads to diseases such as heart attack and     stroke. Although there are a number of drugs available that lower blood pressure, these are     not always fully effective. Furthermore, there are even fewer drugs that simultaneously lower     blood pressure, reduce proteinuria, and slow down kidney damage in CKD.      Recent research has shown that drugs like sitaxsentan not only lower blood pressure but also     reduce proteinuria and potentially slow down the progression of CKD [1,2]. Before sitaxsentan     can become freely available to individuals with CKD it is important to look at the effects     this drug could have on proteinuria and blood pressure.        1. Goddard J, Johnston NR, Hand MF, et al. Endothelin-A receptor antagonism reduces blood          pressure and increases renal blood flow in hypertensive patients with chronic renal          failure: a comparison of selective and combined endothelin receptor blockade.          Circulation 2004;109:1186-1193.        2. Krum H, Viskoper RJ, Lacourciere Y et al. The effect of an endothelin receptor          antagonist, bosentan, on blood pressure in patients with essential hypertension. New          Engl J Med 1998;338:784-790.   "
226449|NCT00817050|"     This was a one-day single dose trial conducted to compare patient's preference for Nasonex®     (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2     sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take     one dose of the opposite medication. Questionnaires were given to each patient after each     drug dose to evaluate patient product preference.   "
226450|NCT00817063|"     The purpose of this study is to investigate the safety and efficacy of alitretinoin in the     treatment of severe chronic hand eczema that does not respond to treatment with potent     topical steroids.   "
226451|NCT00817076|"     The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius)     syrup in children with allergic skin inflammation. Patients took desloratadine syrup once a     day for 28 days. Once a week, the doctor measured the patient's symptoms. This measurement is     called SCORAD. The doctor also rated how much relief the patient got from treatment and     recorded any side effects.   "
226452|NCT00817089|"     This is a study involving treatment for alcohol dependence among males of European or Asian     decent. The ultimate aim of this line of investigation is to further establish a genetic link     between alcohol dependence and treatment by defining an endophenotype associated with     treatment response. The study will combine two inpatient alcohol challenge sessions along     with 12 weeks of outpatient treatment using random assignment to either naltrexone or     placebo.   "
226453|NCT00817102|"     This study will evaluate the effectiveness of CorCTA by comparing the results of the test     with another imaging method called Fractional Flow Reserve (FFR), which is done as a part of     the cardiac catheterization.   "
226454|NCT00817115|"     The aim of the proposed study is to compare the exposure dose and diagnostic performance of     region-of-interest fluoroscopy compared to standard fluoroscopy in patients and     interventionists during cardiac interventional procedures. It is hypothesized that systematic     application of x-ray attenuation will significantly reduce the radiation exposure of the     interventional procedure while maintaining image quality, thereby decreasing risk to the     patient.   "
226455|NCT00817128|"     The current Dutch CBO guideline treatment of Complex Regional Pain Syndrome Type I (CRPS-1)     is very disappointing with chronification, disability and subsequent high medical costs and     personal suffering. A possible better treatment is intensive function-oriented physical     therapy or Pain Exposure in Physical Therapy (PEPT). However, there are no adequate studies     performed that demonstrate the efficacy of PEPT and therefore PEPT is lacking in the Dutch     CBO CRPS-1 guidelines. Despite a lacking scientific argumentation, the PEPT approach or     Macedonian therapy, is now being adopted on a large scale among physical therapists in The     Netherlands. There are two level C retrospective cohort studies demonstrating a promising and     clinical relevant beneficial effect on pain and function after PEPT. In response to the     growing demand for scientific argumentation among doctors and physical therapists with     respect to the efficacy of PEPT, we conducted a pilot study at the UMC St Radboud Nijmegen.     The results of this pilot study were very promising and therefore, we decided to design a     large RCT to investigate the treatment effects and costs in CRPS patients treated with PEPT     compared to CRPS patients treated with usual therapy according to the Dutch CBO guidelines.   "
226457|NCT00817154|"     The major goal of this project is to adapt an existing group-based psychosocial program to     enhance community functioning in older people with serious mental illness (SMI). The focus of     the adaptation is designing and evaluating an individually based rehabilitative program for     older people with SMI who either cannot or choose not to access a group program.   "
226458|NCT00817167|"     The study is aimed to evaluate and describe the added value of inReach planning software on     performance characteristics of standard bronchoscopy.   "
226658|NCT00819234|"     Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with     randomized study medication. The purpose of the extension study is to examine the long-term     (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide     and metreleptin, administered as separate subcutaneous (SC) injections, in obese and     overweight subjects.   "
226459|NCT00817180|"     This study is a preliminary study designed to determine the safety and effectiveness of HFCWO     using the InCourage vest system as an airway clearance technique for the treatment of CF. The     study will compare HFCWO to the most commonly used airway clearance technique in Canada,     namely the Positive Expiratory Pressure technique in patients with CF over a period of one     year. As this is a preliminary study, it will not be able to determine if the vest is     equivelant to PEP, but will provide the information needed to plan a larger study to answer     that question.   "
226460|NCT00817193|"     The purpose of this study is to test the effectiveness of a structured physical activity     program, relative to a wellness program, in preventing the onset and progression of     disability in the setting of senior housing communities, which are sometimes called housing     with services.   "
226461|NCT00817206|"     This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3     controlled trial to establish the efficacy and safety of conversion from maintenance     immunosuppressive therapy with Prograf® capsules (tacrolimus, Astellas Pharma US, Inc.,     Deerfield, IL) twice daily to maintenance immunotherapy with LCP Tacro™ tablets (tacrolimus,     LifeCycle Pharma A/S, Hoersholm, Denmark) once daily for the prevention of acute allograft     rejection in stable adult kidney transplant patients. Patients on a stable dose of Prograf®     will be randomly assigned to be converted from Prograf® twice daily to LCP Tacro™ once daily     or to remain on maintenance therapy with Prograf® twice daily. Patients entering the study     will be treated with assigned study drug and followed for one year for patient survival and     the incidence of graft rejection or graft loss.   "
226462|NCT00817219|"     The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX     ointment in adolescent patients with psoriasis vulgaris.   "
226463|NCT00817232|"     Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain     and disability. Treatment of the disorder is not always successful, and it often recurs or     becomes chronic. More effective management options are required. There is evidence that     electric microcurrent can promote tissue healing and symptom resolution in various chronic     hard and soft tissue disorders, but few human studies investigating its use with chronic     tendon problems. It is an easily applied therapy with very few reports of side effects. It     can be applied at home using a portable unit and, if it is clinically effective, may also     prove more cost effective than other therapies.      A clinical trial is planned to evaluate the therapy but, in the absence of relevant published     evidence, a preliminary study is required to look for a treatment effect and inform a power     calculation for sample size, The study will also allow some investigation of dose-dependence,     which is a key issue in many forms of electrotherapy. Finally it will enable evaluation of     elements of the full trial protocol so that any weaknesses can be addressed before it begins.   "
226464|NCT00817245|"     Etiology of ICSCR is not known however recent studies regard the role of immunologic and     infectious processes in the pathogenesis of ICSCR.one of these hypothesis is the role of     helicobacter pylori in the pathogenesis of ICSCR so perhaps treatment of h pylori have     positive effect on the remission of ICSCR.   "
226465|NCT00817258|"     The primary objective of this study is to determine the overall survival in patients with     stage II (T1-2N1M0) NPC treated with concurrent chemotherapy and radiotherapy.      Secondary objectives of the study are to evaluate the disease free survival, and distant     metastases free survival of patients with stage II NPC treated with this regimen   "
226466|NCT00817271|"     The purpose of this study is to evaluate the response to Glucagon versus the spontaneous     hormonal response to low blood sugar levels in T2DM Patients treated with AZD1656 and     Metformin   "
226467|NCT00817284|"     Significant activity (radiographic response rates of approximately 60%) has recently been     demonstrated in phase II studies in patients with relapsed GBM from the combined use of     Irinotecan (CPT-11) and bevacizumab. The 6-month progression-free survival rate is 30% and     median survival duration is 9 months. The current first line therapy of GBM patients     following initial surgical resection/debulking is the concomitant use of cerebral     radiotherapy and the orally available alkylating agent temozolomide, followed by temozolomide     for 6 months post-radiotherapy.      Considering the significant activity of the combination of Bevacizumab + irinotecan in     patients with recurrent GBM, and considering the activity of temozolomide in GBM, it is     proposed that the combination of Bevacizumab + Temozolomide may also be an active regimen.     Bevacizumab + Temozolomide display non-overlapping toxicity clinically and thus their     combined use without significant dose-reductions seems rational.      The toxicity from the combined use of the two drugs prior to radiotherapy, as well as the     toxicity when administered together with radiotherapy, is evaluated.      This study will try to identity whether Bevacizumab and Irinitecan or Bevacizumab and     Temozolomide should be the experimental arm in future phase III comparison with standard care     with concomitant Temozolomide and radiotherapy.   "
226468|NCT00817297|"     The purpose of this study is to compare a new noninvasive ventilator to existing ventilators     already used for patient care.   "
226469|NCT00817310|"     Currently, when premature infants develop severe intraventricular hemorrhage (IVH), a type of     intracerebral bleed, there are no proven therapeutic interventions to prevent the devastating     consequences of this event. These children will be likely to develop cerebral palsy or severe     cognitive delays.      The purpose of our study is to characterize differences in brain physiology, imaging, and     function between premature infants with severe IVH and controls. The goals for gathering this     information are to generate baseline data, which could facilitate early screening for     complications of IVH in premature infants. These baseline data would also allow the design     and implementation of early therapeutic interventions to help rehabilitate premature infants     with severe IVH.   "
226482|NCT00817479|"     The study objective is to compare changes in expression of glucocorticoid-induced genes that     may be involved in cell survival signaling in the tumors of ovarian cancer patients before     and after an intraoperative dose of 20mg dexamethasone.   "
226578|NCT00817583|"     The primary objective of this study is to determine the response rate, tolerance and overall     survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF     regimen) and concurrent chemoradiation.      Secondary objectives of the study are to evaluate the distant metastases free survival, and     disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen.      The third objective of this study is to evaluate who may benifit from this treatment regimen.   "
226470|NCT00817323|"     PURPOSE The purpose of this study is to elucidate whether quetiapine fumurate (Seroquel)     exerts its antidepressant activity in bipolar disorder through altering either serotonergic     or catecholinergic activity.      HYPOTHESIS By depleting either serotonin or catecholamines in successfully treated bipolar     patients, relapse will be induced and reveal which neurotransmitters are effected when     receiving normal treatment      JUSTIFICATION While the exact mechanism of action of the classical antidepressants is not     fully understood, strong evidence implicating serotonin and noradrenalin to be necessary     (albeit insufficient) for the resolution of depression comes from neurotransmitter depletion     studies. This biological evidence for each of these two neurotransmitters come from study     paradigms in which the neurotransmitter (or its precursor) are selectively and effectively     depleted from patients who have responded to antidepressants which either work through     enhancing serotonin (for example, SRI antidepressants) or catecholamines (such as secondary     amine tricyclics, Reboxetine, etc.). It has been shown, and replicated, that patients that     respond to serotonin enhancing drugs precipitously and dramatically relapse when given a diet     (often in the form of a milkshake) which is void of tryptophan, the precursor of serotonin.     This diet often contains other long-chain amino acids to prevent any residual tryptophan in     the system from entering the CNS. These patients who have then relapsed on the     tryptophan-free diet have their tryptophan repleted and their mood improves often over a very     short time frame (for example, five hours). When this technique is performed on patients     responding to catecholamine-enhancing drugs there is no significant clinical effect. A     similar approach can be taken with patients who respond to noradrelanine-enhancing drugs.     Specifically, their catecholamine stores can be depleted by using dietary tyrosine. This     reduces the synthesis of catecholamines and dopamine thus depleting pre-synaptic     noradrenaline. For patients who responded to noradrenaline-enhancing drugs, this results in a     relapse in terms of depressive symptomatology. When this dietary tyrosine strategy is applied     to serotonin responders, there is no significant clinical effect.   "
226471|NCT00817336|"     N-methyl-D-aspartate (NMDA)-type glutamate receptors are thought to play a pivotal role in     neurocognitive dysfunction associated with schizophrenia. Further, several novel     glutamate-based classes of compound are presently in development as potential novel     treatments for persistent negative and cognitive symptoms. The study will assess     effectiveness of a NMDA-based intervention on biomarkers related to schizophrenia as a     mechanism for developing appropriate outcome batteries for future trials of novel compounds.   "
226472|NCT00817349|"     Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional     patient populations.   "
226473|NCT00817362|"     The purpose of this study is to see if IPI-504 in combination with trastuzamab is an     effective treatment in HER2 positive metastatic breast cancer   "
226474|NCT00817375|"     The purpose of this study is to determine whether pharmacogenomic study predict     antidepressant responsiveness in advance before the appearance of the drug effects until 4~6     weeks after drug administration.   "
226475|NCT00817388|"     Completion of a brief survey tool and providing an urine specimen. The study purpose is to     improve our understanding of interstitial cystitis and painful pelvic syndrome.   "
226476|NCT00817401|"     Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and     mortality in term and preterm neonates. Birth asphyxia accounts for 23% of neonatal deaths     globally and survivors suffer from long term neurological disability and impairment. Although     many neuroprotective strategies appeared promising in animal models, most of them were not     feasible and effective in human newborns. However, hypothermia was reported not to be     effective if introduced beyond and thus should be introduced within 6 hrs after     birth.Applying this selection criterion naturally would deprive many patients of the     opportunity of hypothermia treatment.   "
226477|NCT00817414|"     This study will determine the maximum dose of LCI6999 with respect to effect on the     ACTH-stimulated cortisol response in patients with hypertension   "
226478|NCT00817427|"     This study is designed to determine if either short night time sleep or poor night time sleep     could be a risk factor for increasing the rate at which kidney function deteriorates in     persons with mild to moderate kidney disease.   "
226479|NCT00817440|"     Hypothesis: under fasting there will primarily be an activation of growth hormone(GH)     signalpathways and a inhibition of insulin signalpathways, and the opposite will happen under     physical activity.      Primarily we will investigate markers for GH and insulin signaltransduction in muscle- and     fat-biopsies after fasting for 72 hours and after 1 hour of ergometer-cycling at 65% Vo2max.      In addition to this we will investigate the effect of fasting and exercise on the velocity of     carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.   "
226480|NCT00817453|"     Purpose:        1. To see if cytokine levels and oligomeric alpha-synuclein levels in blood and          cerebrospinal fluid could be used as biological markers for Parkinson's disease (PD)          onset and progression.        2. To characterize and define patterns in the clinical features of sleep, olfactory          function and motor function in the early stages of idiopathic (sporadic) Parkinson's          disease (PD)and atypical or late Parkinsonian Syndromes.      Procedures:      All subjects, control,early PD diagnosis and atypical or late Parkinsonian Syndromes, will     have 1) a medical and neuro history and physical including videotaping of movements, 2)     neuropsychological testing, 3) a sleep study, 4) olfactory (sense of smell) testing, 5)blood     draw and LP for serum and CSF testing, & 6) functional MRI. All of these procedures are often     done in the diagnosis of PD. Any test performed prior to enrollment as part of the clinical     evaluation may be used in place of repeating the procedure. Subjects will have 1 set of study     visits (up to 3 visits) in order to accomplish a complete set of data.   "
226481|NCT00817466|"     Bronchiolitis is a common lower respiratory disease typically affecting infants and children     generally younger than 2 years of age. The disease leads to hospital admissions, is a major     cause for hospitalisation of young children and infants during winter epidemics, may be     severe sometimes requiring ventilatory support and rarely death. The clinical disease as     described by Court is characterised by nasal flaring, tachypnoea, dyspnoea, chest recessions,     crepitations and sometimes sibiliations. Respiratory Syncytial virus is the most common     cause, but also other respiratory vira may cause the disease. Bronchiolitis is a well known     risk factor of asthma development in childhood1,2.      Management is generally supportive, whereas symptom reducing therapy is debated with no     international consensus. Furthermore, there are many unresolved questions related to the     prognosis of bronchiolitis, its role in development of chronic lung disease in particular     regarding the association between early bronchiolitis and asthma development. The present     project will particularly focus on: 1)Treatment efficacy related to various outcomes during     active disease, 2) retrospectively assess treatment efficacy in relation to later development     of allergic disease, 3) assess the role between different vira and asthma prognosis as well     as 4) identify possible prognostic factors involved in the progression from bronchiolitis to     further airways disease.   "
226483|NCT00817492|"     This study will help determine the relationship between impaired sleep and chronic kidney     disease, specifically to determine if sleep disturbances are a risk factor for worsening     kidney function.   "
226485|NCT00817518|"     This study will determine the maximum tolerated dose and the dose-limiting toxicities of     RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the     study, groups of patients will be sequentially enrolled to receive ascending oral doses of     RO4987655 daily for 28 days. The starting dose of 1mg daily will be escalated in subsequent     groups of patients after a successful assessment of the safety and tolerability of the     previous dose. In Part 2 of the study, patients with metastatic or advanced malignant     melanoma, or any other responsive tumor type, will be randomized to receive either the     maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated     time on study treatment is until disease progression, and the target sample size is <100     individuals.   "
226486|NCT00817531|"     We want to learn if dasatinib will make triple negative breast cancers smaller. We also hope     that we can learn more about what makes triple negative breast cancers grow. We believe this     information will help us to predict which patients will benefit from taking this drug or     other drugs like it.      This study is a neoadjuvant study, which means that it is only open to women who have not     had any treatment for their breast cancer. Neoadjuvant studies allow the study doctor to look     at how the cells in your cancer change after taking the study medication. This will help us     to understand whether or not dasatinib is an effective treatment for breast cancer. It will     also help us to learn more about triple negative breast cancer and how to treat it.   "
226487|NCT00817544|"     The study is conducted to examine absorption of C14-ORM-12741 from intestine to bloodstream,     distribution to bloodstream, metabolism in the liver and excretion of the parent drug and     metabolites to faeces, urine and expired air   "
226488|NCT00810472|"     Penetrating keratoplasty is one of the most commonly performed transplantation surgeries.     Graft rejection is a major complication. HLA compatibility has already been demonstrated an     effective prophylaxis in several retrospective investigations. The purpose of the     investigators randomized clinical trial is to demonstrate superiority of HLA matching in     comparison to random graft assignment with respect to the endpoint 'time to first endothelial     graft rejection' in penetrating keratoplasty. The investigators will perform DNA-based allele     resolution typing.   "
226489|NCT00810485|"     The purpose of this study is to evaluate the effect of ADX10059 in patients with     gastroesophageal reflux disease who are partial responders to proton pump inhibitors   "
226490|NCT00810511|"     The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.   "
226491|NCT00810524|"     Influence of antiviral treatment to the long term prognosis of patients with chronic HBV     infection. The aim of antiviral treatment for HBV is to reduce the long term severe     complications. In this study, the investigators divided patients with chronic HBV infection     into two groups, which start early antiviral treatment and conventional antiviral treatment     respectively. All the patients will be followed for ten years. From this study, the     investigators want to find out the optimal time for patients with chronic HBV infection to     start antiviral treatment.   "
226492|NCT00810550|"     Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most     common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The     standard test to find coronary artery disease is coronary angiography. This test is highly     accurate but is invasive and carries a small risk of complications. This study investigates     ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery     disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid     ultrasound will have excellent negative predictive value for severe CAD.   "
226493|NCT00810563|"     The use of bupivacaine , an anesthesic, in laparoscopic portals is recommended in some     surgeries. In the ase of tubal ligation by electrocoagulation, where pain is reduced, there     is no evidence of this benefit. The objective of this study is to verify the degree of pain     after laparoscopic tubal ligation surgery in patient who received bupivacaine 0.5% in the     portal, or placebo   "
226494|NCT00810576|"     Primary Objectives:        1. To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma          (NHL)receiving the combination of vorinostat and bortezomib        2. To evaluate the safety and tolerability of the combination of vorinostat and bortezomib          in patients with relapsed or refractory T-cell NHL.      Secondary Objectives:        1. To assess overall survival and time to treatment failure in patients with T-cell NHL          treated with the combination of vorinostat and bortezomib.        2. Correlative studies will be done to assess the role of vorinostat mediated apoptosis          along with bortezomib synergy. Changes in marker expression from baseline to post          treatment will be correlated with patient clinical response.   "
226495|NCT00810589|"     Clinical pharmacology trials investigating insulin detemir in subjects with type 1 diabetes     have shown a prolonged and reproducible action profile of insulin detemir compared with NPH     insulin and insulin glargine. Duration of action of insulin detemir has been reported to be     up to 24 hours.9,10,11 It has, however, been proposed that the mean duration of action is     underestimated in glucose clamps lasting only 24 hours. This is so because a duration of     action longer than 24 hours in individual clamps will be set to 24 hours in the mean     calculation, whereas a shorter duration of action in individual clamps will be set to the     true value.      It has been shown in clinical pharmacology trials that NPL insulin has an action profile     comparable to NPH insulin in subjects with type 1 diabetes. , However, a direct comparison of     pharmacodynamic properties of insulin detemir and NPL insulin has not been performed to date.      To get further insight into the pharmacodynamic properties of insulin detemir compared with     NPL insulin, this trial has been designed to compare pharmacodynamics in general and duration     of action in particular between insulin detemir and NPL insulin in subjects with type 1     diabetes.   "
226523|NCT00810953|"     The purpose of this study is to investigate the safety and possible efficacy of the use of     pentamidine in the treatment of pancreatic cancer metastasis in subjects receiving standard     therapy.   "
226524|NCT00810979|"     The purpose of this study is to determine whether SLx-4090 in combination with statin therapy     will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.   "
226624|NCT00818753|"     To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg     twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a     standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of     elective percutaneous coronary intervention (PCI).   "
226496|NCT00810602|"     The proposed research study is to test the drug vorinostat, in a new use as an additional     medication, with other standard treatments for the prevention of severe acute graft versus     host disease (GVHD).      If this treatment is safe and effective, when combined with a reduced intensity transplant,     the research may achieve a more effective therapy for patients with high-risk, blood cell     related cancers.      All subjects will receive an identical, known treatment to test if the treatment is safe and     effective (a phase II trial). For patients to take part they must have a high-risk, blood     cell cancer, be suitable candidates to receive a reduced intensity transplant and have a     matched, related donor.      Adult subjects (age 18 years and older) will be considered as subjects provided, as detailed     in the protocol, they meet additional criteria and are not excluded from participating. About     fifty (50) subjects will be enrolled in this study at the University of Michigan.      Patients who receive blood stem cell transplants (HSCT), also called bone marrow transplants,     to treat their cancer are at risk for serious complications, which may sometimes be fatal.     The more common, serious ones are relapse (return of their disease), body organ injury from     the intensity of the chemotherapy given prior to their transplant, and a serious complication     called graft versus host disease (GVHD). GVHD is a form of rejection, where the transplanted     cells of the donor attack the recipient's body as foreign, and do damage to organs and     tissues.      To decrease the side effects of the chemotherapy given before a transplant, reduced intensity     treatment plans(regimens)have recently been developed at a number of transplant centers. A     decrease in the side effects of chemotherapy (called toxicities) has been achieved; however,     this success with less intensive treatments has been partially offset by less successful     results in controlling the patient's cancer.      As mentioned above, GVHD is a form of transplant rejection. GVHD can affect the digestive     system, skin, liver and other body systems. GVHD can increase the risk of infection. After a     matched, related donor stem cell transplant, GVHD when severe, is a major cause of     discomfort, organ damage, and even death. When a graft vs host reaction develops, but is kept     under control, studies show there may be a beneficial graft versus tumor effect, helping to     destroy tumor cells in the patient, and thus providing a more effective control of their     cancer.      The goal of this study is to try to maximize the potential benefits, of giving patients less     intense chemotherapy to reduce the toxic effects, letting the graft vs host effect help in     destroying tumor cells, but preventing acute severe GVHD by using the drug vorinostat,     combined with standard medicines, to reduce the chance of serious GVHD-related complications.   "
226497|NCT00810615|"     The purpose of this study is to determine if hyperbaric oxygen therapy (HBOT) improves the     cognitive function of OIF/OEF individuals who have chronic mild to moderate traumatic brain     injury (TBI). Cognitive function includes such things as thinking, remembering, recognition,     concentration ability and perception. Traumatic brain injury is common with head injuries     caused by blows to the head, nearby explosions, or concussion. Subjects will be assigned to     an intervention or sham arm. Computer based cognitive tests will be used as outcome measures.     Subjects are enrolled by invitation only.   "
226498|NCT00810628|"     The purpose of this pilot program is to develop and evaluate a new treatment program for     depression in Parkinson's disease (PD). The treatment uses Cognitive Behavior Therapy(CBT)to     teach patients how to become more aware of their thoughts and feelings and to change thinking     patterns and behaviors that may be related to depressive symptoms. This is the first time     that this treatment has been used in a group setting for depression in PD.      Target population is patients in the Movement Disorders Clinic at Oregon Health & Science     University who have Parkinson's disease and mild to moderate depression.   "
226499|NCT00810641|"     The purpose of this study was to compare the immediate efficacies of each treatment maneuvers     in treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).   "
226500|NCT00810654|"     Oral supplementation with enzymes that can cut gluten has been suggested as a potential     treatment modality for coeliac disease. In the present study the investigators wish to     determine if co-administration of such an enzyme, a prolyl endoprotease derived from the food     grade organism Aspergillis niger (AN-PEP), is capable of detoxifying 8 grams of gluten in a     commercial food product.   "
226501|NCT00810667|"     The objective of this study is to explore the efficacy, safety and cognitive properties of Lu     AE58054 as augmentation therapy to risperidone in patients with schizophrenia.   "
226502|NCT00810680|"     The purpose of this study is to determine whether Valproic acid, as a single agent is     effective in the treatment of Chronic Lymphocytic Leukemia which has relapsed or is     refractory to therapy with standard drugs.   "
226503|NCT00810693|"     The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521     given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension     (PAH).   "
226504|NCT00810706|"     The ATENA phase III randomized parallel-group multicenter trial is designed to compare 5     years of adjuvant exemestane versus 5 years of observation in postmenopausal women with     operable breast cancer who have received 5-7 years of adjuvant tamoxifen. The primary     endpoint for the core protocol is disease-free survival (DFS). Exemestane treatment is     planned for 5 years unless disease relapse or excessive toxicity is documented, the patient     refuses further treatment or any new anti-cancer therapy is initiated.   "
226505|NCT00810719|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving gemcitabine together with erlotinib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving gemcitabine together with erlotinib     works in treating patients with metastatic or recurrent pancreatic cancer.   "
226506|NCT00810732|"     This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney     disease.   "
226507|NCT00810745|"     This randomized study was designed to compare the 2 year clinical and functional results with     the STARR procedure using a new curved cutter stapler or the same operation done with 2     traditional circular staplers.   "
226508|NCT00810758|"     To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral     doses of PF-04878691.   "
226509|NCT00810771|"     The goal of this study is to evaluate whether an educational tool about colorectal cancer     (CRC) completed on a computer that helps patients clarify their CRC screening preferences     will lead to increased screening rates for CRC compared to standard information delivered via     computer.   "
226510|NCT00810784|"     VTE prophylaxis is not as routinely employed in medically ill patients as compared to     surgical patients. This retrospective chart review project will evaluate the effectiveness of     VTE prophylaxis in medically ill patients at the University of Utah Hospitals and Clinics     compared to current literature. The study will ultimately serve as a quality improvement     project to help improve patient care.   "
226511|NCT00810797|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     exemestane may fight breast cancer by lowering the amount of estrogen the body makes.      PURPOSE: This phase II trial is studying how well exemestane works in treating postmenopausal     women with stage IV breast cancer.   "
226558|NCT00811421|"     The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to     Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the     prevention of malaria effects on the mother and her infant.   "
226512|NCT00810810|"     This study is designed to provide information on patients' immune response after exposure to     transfused blood.      Blood transfusions may have opposite immune effects on patients. One is sensitization. The     other is immunosuppression. The magnitude of these effects in patients who are not on     chemotherapy is unknown.      These effects are thought to be due largely to white blood cells present in the transfusion     product. Leukofiltration and gamma-irradiation are the special treatments that deplete     white blood cells. A combination of leukofiltration and gamma-irradiation pretreatment of     donor blood is thought to deplete the white blood cells most effectively.      In this study, patients scheduled for cardiac surgery are randomly assigned to receive blood     products pretreated in one of three ways: untreated, filtered or filtered and irradiated. If     their physician orders transfusions, they will receive products assigned to their group.     Patients are asked to provide two blood samples during the 4 weeks after surgery.      Studies will measure changes in antibody to HLA and in cells that regulate the immune     response. The levels of sensitization and immunosuppression will be correlated to the     transfusion products received.   "
226513|NCT00810823|"     Gastric bypass surgery has in many studies shown total remission of type 2 diabetes as early     as 1 - 2 days after surgery and this is before any real weight loss has occurred. This     suggest that the remission of the diabetes is due to the direct effect of the operation more     that the secondary effect of the weight loss. The reason for the major effect on the glucose     metabolism after gastric bypass surgery is still unaccounted for.      This PhD. project will try to unveil some of the mechanisms that could explain the effect of     gastric bypass surgery on the glucose metabolism seen in patients with type 2 diabetes.      The hypothesis of the study is that a factor X will course the remission of the diabetes.     This factor X is related to the anatomic changes of the gastro intestinal tract, by     eliminating the foods passage through the distal part of the ventricle and the duodenum, in     combination with the Roux- en-Y sling.      The PhD. project will consist of clinical trails on patients that will undergo gastric bypass     surgery. The studies will take place before and within the 1. week after surgery. The     investigators will measure different hormones and adipokines in fast and the postprandial     state. To discover possible new proteins the investigators will run proteomic on some     samples. All the results will be compared to the same parameter on patients undergoing     gastric banding, where the anatomy of the intestine hasn't been changed.   "
226514|NCT00810836|"     The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms     of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who     still suffer symptoms of RA. The purpose is also to ensure that the combination of     methotrexate is safe for patients to take and that any side effects are acceptable to     patients with RA.   "
226515|NCT00810849|"     Human immunodeficiency virus (HIV) infection puts people at risk of opportunistic infections,     such as tuberculosis. In Africa, the HIV epidemic has resulted in an increase in the number     of cases of tuberculosis affecting various parts of the body, including the membrane     surrounding the heart (i.e., pericardium). Pericardial tuberculosis is a serious form of     tuberculosis that results in the death or disability of 1 in 2 affected people despite the     use of antituberculosis medication. It has been suggested that the addition of     corticosteroids to the antituberculosis medication could result in the reduction of the     number of deaths caused by the disease, but this proposal remains to be confirmed in     appropriately designed clinical trials. Similarly, vaccination with the Mycobacterium w     injection is also proposed as a possible way of reducing the damage caused by the     tuberculosis infection of the heart. The investigators are proposing to conduct a clinical     trial in which people who are on antituberculosis treatment for pericardial tuberculosis will     be randomly allocated to receive either prednisolone or a matching placebo tablet, or     Mycobacterium w injection or placebo injection. The number of people who die or who develop     hardening of the pericardium with compression of the heart (called pericardial constriction)     or who need emergency evacuation of the pericardial fluid from pericardial sac for severe     compression (called tamponade) will be compared in each group to determine whether the use of     corticosteroids or Mycobacterium w injection is safe and results in reduction in the death     rate. If corticosteroids and Mycobacterium w are shown to safely reduce the death rate, then     they will be recommended for use in all patients with tuberculosis of the pericardium in the     future.   "
226516|NCT00810862|"     Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American     children.   "
226517|NCT00810875|"     The purpose of this study is to determine if hepatitis C virus and influenza virus vaccine     components can cross the placenta and stimulate an immune response in the fetus.   "
226518|NCT00810888|"     The purpose of this study is to determine if computed tomography angiography can predict     which individuals with intracerebral hemorrhage will experience significant growth in the     size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study     will compare the drug recombinant activated factor VII (rFVIIa) to placebo to determine the     effect of rFVIIa on intracerebral hemorrhage growth.   "
226519|NCT00810901|"     This study will test the effectiveness of a multimedia campaign to educate ethnic minority     teens about the choice to become a designated organ donor on their first driver's license.   "
226520|NCT00810914|"     The investigators intend to perform a large randomized trial using standardized obstetrical     and anesthetic practice at a single institution to determine the effects of patient     controlled epidural analgesia on obstetrical and neonatal outcomes.   "
226521|NCT00810927|"     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in     perfusion pressure. For a long time it had been assumed that the choroid is a strictly     passive vascular bed, which shows no autoregulation. However, recently several groups have     identified some autoregulatory capacity of the human choroid. In the brain and the retina the     mechanism behind autoregulation is most likely linked to changes in transmural pressure. In     this model arterioles change their vascular tone depending on the pressure inside the vessel     and outside the vessel. In the choroid, several observations argue against a direct     involvement of arterioles. However, the mechanism behind choroidal autoregulation remains     unclear.      In the present study autoregulation of the choroid will be investigated during a decrease in     ocular perfusion pressure, which will be achieved by an increase in intraocular pressure.     Pressure/flow relationships will be investigated in the absence or presence of a NO synthase     inhibitor. As a control substance the alpha-receptor agonist phenylephrine will be used.   "
226525|NCT00810992|"     Coronary artery disease has a high death toll in the Western world. Changes in lifestyle,     particularly in nutrition and physical activity may significantly reduce a severe coronary     atherosclerosis within one year without the use of medication. Several dietary studies have     shown that not only the progress of coronary artery disease can be slowed down, but it may     also increase significantly the survival of these patients.      Up until now there is little known about therapeutic effects by complementary medicine. In     particular, Traditional Tibetan medicine dietary programs have shown in few case reports that     weight could be reduced in patients with obesity.      Therefore, the investigators developed a specific dietary program for patients with coronary     artery disease, who have an increased cardiovascular risk profile according to the criteria     by the International Diabetes Federation (IDF).   "
226526|NCT00811005|"     The purpose of this prospective, randomized, controlled, single-blinded investigation is to     study the efficacy, tolerability and safety of oral photochemotherapy (PUVA) combined with     acitretin versus oral PUVA combined with systemic fumaric acid esters (FAE) in patients with     pustular palmoplantar psoriasis.      Patients will be randomized and allocated in concealed manner to one of the two treatment     arms: acitretin-PUVA or FAE-PUVA.   "
226527|NCT00811018|"     This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily     by subjects with PAH until sitaxsentan, in a particular country or region, is commercially     available for the treatment of PAH or the study is closed.   "
226528|NCT00811031|"     Objectives:      Primary:        -  To evaluate the association of the probability of increase in phosphorylation of          platelet-derived growth factor receptor (PDGFR) of > 0.5 in peripheral blood leucocytes          following pre-operative docetaxel chemotherapy, with progression-free survival in          localized castration-resistant prostate cancer (CRPC)      Secondary:        -  To evaluate the association of the probability of increase in phosphorylated          platelet-derived growth factor receptor (PDGFR) expression in peripheral blood          leucocytes > 0.5 with indices of tumor regression including PSA-decline by 50% and          measures of objective regression of tumor by transrectal MRI following pre-operative          docetaxel therapy.        -  Explore associations of probability of increase in phosphorylated PDGFR in peripheral          blood leucocytes following pre-operative docetaxel therapy with plasma PDGF kinetics and          spatial and quantitative PDGF and phosphorylated PDGFR expression in tumor and stromal          compartments in resected specimens.        -  Evaluate the association of probability of increase in phosphorylated PDGFR expression          in peripheral blood leucocytes following pre-operative docetaxel chemotherapy with          overall survival outcomes.        -  Assess global quality of life measures at baseline and 6 and 12 months post-operatively.        -  Create a tissue archive comprising tumor and peripheral blood specimens as a suitable          resource for future genomic and proteomic studies.   "
226529|NCT00811044|"     -  This study is in the area of Type 2 diabetes and genetics        -  Healthy Volunteers and those with mild type 2 diabetes may be eligible to participate        -  This study is searching for genes that may affect the body's processing/digestion of          glucose/sugar   "
226530|NCT00811057|"     Preterm birth is the most common and costly complication in obstetrics. It complicates up to     11% of all pregnancies and it is responsible for 70% of sick babies. The ideal way to stop     preterm labor when it occurs (which drug to use) is not known. Currently magnesium sulfate is     used by about 95% of all practitioners, but recent data suggest magnesium given this way may     be harmful for the baby's future development. Other drugs such as antiprostaglandin agents     are very effective in stopping uterine activity, but particularly when used for >48 hours     have been associated with both maternal and fetal sides effects. Lastly, calcium channel     antagonists are effective in stopping contractions and have very little in the way of     maternal and fetal side effects, but less data is available in the United States on their     use. Because there is no FDA approved drug to stop preterm labor, we purpose to randomize all     women with preterm labor (20-34 weeks) to receive one of the above three methods of stopping     preterm labor. The primary outcomes will be to see which agent stops the uterine contractions     most effectively, for the longest period of time with fewest relapses and results in     significant prolongation of pregnancy. If one of these agents is clearly superior to the     other two it would help women avoid early delivery or have significant extension of their     pregnancy to avoid some of the complications of preterm birth in the baby.   "
226531|NCT00811070|"     This is a two-part safety and efficacy study of SKI-606 in subjects who have Philadelphia     chromosome positive leukemias (CML). Part 1 will be a dose-escalation study, in which an     escalating dose of SKI-606 (Bosutinib), up to 600 mg, will be studied in subjects with     imatinib resistant/refractory or imatinib intolerant chronic phase CML. Part 2 will evaluate     the safety and efficacy of the maximum tolerated dose (MTD) of SKI-606 (Bosutinib)identified     in Part 1 of the study.   "
226532|NCT00811083|"     Many children with autism have a reduced level of glutathione and a reduced ability to     excrete mercury, resulting in elevated levels in their bodies as demonstrated by blood, hair,     provoked urine, and baby tooth testing. Our earlier studies have demonstrated that DMSA, an     FDA-approved medication for treating lead poisoning in children, is effective in increasing     excretion of mercury and other toxic metals. Based on many clinical reports, we hypothesize     that a 3-month treatment with glutathione and DMSA will result in a reduction of autistic     symptoms in some children with autism.   "
226533|NCT00811096|"     Assess the efficacy of 2 grams of tinidazole given for 5 days with standard dose chloroquine     to achieve radical cure of Plasmodium vivax within a 90 day follow-up period sufficient to     justify an IND and formal phase II evaluation.   "
226534|NCT00811109|"     The purpose of this randomized controlled study is to compare the effects of different new     dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis     in critically ill patients with acute kidney injury.   "
226559|NCT00811434|"     Pediatric patients with chronic liver disease may have Minimal Hepatic     Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological     function.By utilizing cognitive and developmental testing we will determine if patients have     MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a     washout period with no treatment. At this time patients are re-tested and then begin another     three month period switching to the opposite treatment of first 3 months.Final     cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.   "
226535|NCT00811122|"     Alzheimer's disease (AD) is characterized by neuritic plaques, neurofibrillary tangles, and     neuronal cell loss. Amyloid plaques are believed to play an integral role in AD. Elevated     levels of Aβ in the brain are correlated with cognitive decline.      There are no approved ways to measure amyloid load in humans. Several compounds are under     investigation. All of these compounds use radioactive chemical tags for positron emission     tomography (PET) imaging. The most promising compound is 11C-PIB, or Pittsburgh Compound-B.     This compound can be injected and a PET scan performed. This allows doctors to see the     amyloid plaques in the brain, and to use this information to look at other types of dementia     to see if there are differences and/or similarities in the plaques.      We will recruit a total of 30 subjects, 10 from each of the following three diagnostic     categories: frontotemporal dementia (FTD), Alzheimer's disease, and normal volunteers. All     subjects will be given an [18F]fluorodeoxyglucose or FDG-PET scan (if they haven't had one in     the past) and a PIB-PET scan.      The overall objective of this project is to study the biodistribution of 11C-PIB using PET     imaging in normal elderly volunteers and relevant patient groups.   "
226536|NCT00811135|"     This single arm study will assess the efficacy and safety of Avastin in combination with     Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent     or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin     (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of     subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and     Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The     anticipated time on study treatment is until disease progression, and the target sample size     is <100 individuals.   "
226537|NCT00811148|"     The purpose of this research study is to collect and store brain tumor tissue samples for     future research. The samples will become part of the University of Florida Brain Tumor Tissue     Bank/Florida Center for Brain Tumor Research. The goal is to find improved treatments and     cures for brain tumors.   "
226538|NCT00811161|"     The primary objective of this study is to Evaluate the effectiveness of treatment of wrinkles     or damaged skin with the Airgent device.      The secondary objective of this study are to:        -  Evaluate subjects' satisfactory of the treatment.        -  Demonstrate the safety of the Airgent treatment by evaluation of adverse events.   "
226539|NCT00811174|"     Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration.     Octagam 5% is currently registered in more than 60 countries. This study will evaluate the     efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary     immunodeficiency diseases.   "
226540|NCT00811187|"     The purpose of this study is to determine the effectiveness of paracervical block for pain     relief in office hysteroscopy - particularly with the placement of the Essure device.     Subjects will be randomized to receive either paracervical block or saline, and will have     pain assessments performed throughout the procedure. Subjects and physicians will be blinded     to group assignments.   "
226541|NCT00811200|"     The purpose of this study is to demonstrate a statistically significant improvement of visual     acuity after treatment using either Lucentis® or Triamcinolone® compared to no treatment, in     patients with radiation retinopathy.   "
226542|NCT00811213|"     The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway     pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns     that differentiate between sleep and wake. Upon sensing that the patient is awake the device     is able to reduce positive airway pressure PAP aiming to improve patient comfort which should     result in more consolidated sleep. This study will investigate Obstructive Sleep Apnea (OSA)     and a automatically Adjusting Positive Airway Pressure (APAP) device with new technology     called SensAwake™. This requires experimental confirmation in a randomised controlled trial.     Double−blind randomised crossover trial comparing WASO on standard APAP with WASO using APAP     modified by the addition of the SensAwake™ modification on consecutive nights in participants     with moderate−to−severe OSA.      A total number of 45 participants will be recruited from an OSA population, aged 18−65.     Participants will consist of male and female patients diagnosed with moderate−severe OSA     (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants,     according to the protocol approved by the HREC, providing written informed consent will be     enrolled into the study. Patients will be enrolled sequentially according to the     randomisation list. Patients will be randomised to APAP or APAP with the addition of the     SensAwake™ modification. The investigator and study staff will be blinded to the treatment of     any participant.   "
226543|NCT00811226|"     The purpose of this study is to determine the efficiency of Olmesartan medoxomile (OLMETEC®)     alone or in combination with hydrochlorothiazide (OLMETEC PLUS®) in the reduction of arterial     blood pressure in patients with light to moderate hypertension, and to evaluate the     percentage of patients that reach treatment goals using this antihypertensive regimen.   "
226544|NCT00811239|"     In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by     Bungarus multicinctus. Hitherto, these victims have received supportive care only. The aims     of this study were to assess the possible efficacy and side effects of a newly produced     antivenom.   "
226545|NCT00811252|"     To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of     depression by means of the change from baseline in the 24-item Hamilton Depression Scale     (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.   "
226546|NCT00811265|"     Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.   "
226560|NCT00811447|"     Primary objective:      To detect a statistically significant increase in time to progression (TTP) of disease for     the test group (Taxotere® [Docetaxel] combined with cisplatin and 5-fluorouracil [TCF])     relative to the control group (Cisplatin combined with 5-fluorouracil[CF])      Secondary objectives:        -  To detect a statistically significant increase in overall survival (OS) for the test          group relative to the control group.        -  To compare response rate (RR), time to treatment failure (TTF), duration of responses,          safety profiles, quality of life (QOL), and disease-related symptoms.   "
226625|NCT00818766|"     The purpose of this study is to evaluate if post-operative antibiotic prophylaxis decreases     infectious complications when compared to pre-operative antibiotics alone, in patients     undergoing elective thoracic surgery requiring tube thoracostomy (chest tube).   "
226547|NCT00811278|"     Inhaled corticosteroids are widely used as the primary therapy for asthma, which affects     approximately 20 million people in the United States. While many patients respond to     corticosteroid therapy, as many as 25-30% of patients with severe asthma have asthma that is     difficult to treat or steroid insensitive. Predictive biomarkers for the rapid identification     of patients with asthma who will achieve adequate control of their symptoms with inhaled     corticosteroids has the potential to significantly improve asthma management. This proposal     is based on the hypothesis that alterations in gene expression in epithelial cells of the     buccal mucosa can be used as a reliable biomarker to predict corticosteroid response in     patients with asthma. The goals of this proposal will determine if gene expression in     epithelial cells of the buccal mucosa from patients with asthma is in concordance with gene     expression profiles that have been identified through more invasive sampling techniques of     the airway epithelium of asthma patients. The Specific Aims of this proposal are to 1)     investigate the level of variability in gene expression of a subset of inflammatory markers     in buccal epithelium from adult patients with asthma. Aim 1 will be carried out by collecting     buccal samples from three cohorts of subjects (18-55 years of age) from the Pulmonology and     Allergy Clinics at Truman Medical Center during regularly scheduled outpatient visits as     follows: 1) healthy control adult subjects (n=10), 2) patients with asthma treated only with     a short-acting beta2-agonist (SABA, n=10), and 3) patients with asthma treated with low-dose     ICS (n=10). Relative gene expression of inflammatory markers will be determined using     quantitative RT (reverse transcription)-PCR and variability in gene expression will be     determined within and between the three cohorts. Data from the pilot studies described in     this proposal will aid in the determination of appropriate study population sizes for future     investigations with the long-term objective to use changes in gene expression (in buccal     epithelial cells) as a dynamic biomarker for determining corticosteroid response in patients     with asthma.   "
226548|NCT00811291|"     Vitamin-B and Folic intake of Kindergarten kids in Germany is only 50-70% of the official     recommendations. In studies with adults it has been found that for example providing people     suffering from Alzheimer´s disease improved their mental and cognitive abilities when     provided with a high intake of these vitamins.The hypothesis is, that kindergarten kids, 4-6     years of age, could also improve mentally from a recommended intake of B-vitamins and Folic     Acid.        1. screening study: The urine of 1200 kindergarten kids will be analyzed for metabolites of          these vitamins, and the 250 kids with the lowest results will be invited for a          randomized double blind intervention study.        2. intervention study: Participating kids will get an one hour mental and cognitive testing          before and after the intervention. The intervention will be one portion of the          recommended dosage of a vitamin B complex and folic acid , given in a drink (milk, tea,          etc). The assumption is, that the treatment group will perform better than the placebo          group in the second test phase.   "
226549|NCT00811304|"     Specific Aim: The purpose of this study is to determine if labor epidural placement using     real-time (concurrent) ultrasound guided placement is superior to the conventional standard     epidural technique without the use of ultrasound at Magee-Womens Hospital.      Hypothesis: Ultrasound guided labor epidural placement in real-time will decrease the     traditional epidural failure rate from 5% to 1%.   "
226550|NCT00811317|"     We hypothesize that our integrated closed-loop glucose-control system can provide effective,     tight, and safe blood glucose (BG) control in type 1 diabetes, thereby establishing the     feasibility of closed-loop BG control.   "
226551|NCT00811330|"     The purpose of the study is to see if statin therapy will optimize myocardial response to     cardiopulmonary bypass during aortic valve replacement (AVR) for aortic valve stenosis (AVS)     (Phase I) and optimize left ventricular reverse remodeling following AVR (Phase II).     Preliminary evidence indicates that perioperative statin therapy reduce mortality and     morbidity following cardiac surgery. Pleiotropic effects of statins may induce myocardial     preconditioning and optimize myocardial and systemic responses to cardiopulmonary bypass     during AVR. Furthermore statin therapy after AVR may contribute to an optimal left     ventricular reverse remodeling.   "
226552|NCT00811343|"     Tuberculosis is a current infection during anti TNF therapy. After infectious contact, some     patients will develop tuberculosis and some will only be infected without symptoms, they have     Latent Tuberculosis Infection (LTBI) wich can reactivate later. In order to prevent this     tuberculosis reactivation, LTBI diagnosis screening is preconised in patients who need anti     TNF therapy. This diagnosis is made till now by the tuberculin skin test (TST) but this test     is not specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific to MTB infection are     now available.      The primary endpoint of this study is the evaluation of the theoric therapeutic impact of the     use of new tests for diagnosis of LTBI in patients before anti TBF therapy   "
226553|NCT00811356|"     The purpose of this study is to determine if the study drug (antimalarial medication) is safe     when given to healthy subjects as a single dose or as repeated doses, to understand the     effect of food on single doses of study drug and to determine if the study drug has an effect     on other approved medications such as rosiglitazone and rosuvastatin.   "
226554|NCT00811369|"     The purpose of this study is to evaluate whether the combination of fulvestrant and ZACTIMA,     versus fulvestrant plus placebo, results in a significant decrease in the bone marker,     urinary N-Telopeptide (NTx) in postmenopausal women with bone only, or bone predominant,     hormone receptor-positive metastatic breast cancer. A significant decrease will be defined as     a > 30% reduction in urinary NTx level from baseline.   "
226555|NCT00811382|"     EffecT is a prospective, randomized multicenter study to assess whether management of atrial     fibrillation (AF) as well as the early optimization of cardiac resynchronization therapy     (CRT) via Home Monitoring decreases mortality and morbidity compared to conventional     treatment in subjects with a standard indication for CRT with Implantable Cardioverter     Defibrillator (ICD) backup and AF.   "
226556|NCT00811395|"     The primary objective was to evaluate the long-term safety and tolerability of teriflunomide     when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with     multiple sclerosis [MS] with relapses.      Secondary objectives were to evaluate the long-term effect on relapse rate, disability     progression and Magnetic Resonance Imaging [MRI] parameters.      This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865)     studies. Participants who successfully completed the initial study were offered to continue     their treatment (same compound, same dose) for 24 additional weeks.   "
226557|NCT00811408|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as cidofovir may     make tumor cells more sensitive to radiation therapy. Giving cidofovir together with     radiation therapy and chemotherapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of cidofovir in     treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer who are     receiving chemotherapy together with radiation therapy.   "
229693|NCT00852917|"     The objective of this study is to compare the analgesic efficacy and safety of Tramadol Once     a Day 100, 200, 300 mg and Placebo   "
226561|NCT00811460|"     This crossover study will assess the effect of 2 doses of Taspoglutide on first- and     second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a     continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide     300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or     b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be     crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive     placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion     patterns will be assessed. The anticipated time on study treatment is <3 months, and the     target sample size is <100 individuals.   "
226562|NCT00811473|"     The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine     XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating     children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with     placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).   "
226563|NCT00811486|"     Secondary hyperaldosteronism and the non-osmotic release of arginine vasopressin (AVP) are     the major factors in sodium and water retention in pulmonary arterial hypertension with right     ventricular failure. Natriuretic doses of mineralocorticoid antagonist and aquaretic doses of     V2 receptor antagonist will attenuate the sodium and water retention respectively, and be     associated with clinical improvement.   "
226564|NCT00811499|"     This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the     effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating     ankylosing spondylitis, and to further evaluate the drug's safety. Approximately 130 patients     from the US, Canada, Poland and Hungary will be enrolled in this study.   "
226565|NCT00811512|"     The goal is to describe the fundamental aspects of fundoscopic eye in patients with     microphthalmia   "
226566|NCT00811525|"     The Contour Profile Gel Continued Access Study is designed to demonstrate safety of Mentor's     Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction,     or revision. Safety information on the rate of capsular contracture, rupture, and infection     will be collected, and used to help determine device safety.      With approval of MemoryShape™ Medium Height, Moderate Profile (CPG 321) Breast Implants on     June 14, 2013, CPG CA Study subject enrollment has closed and the study has converted to a     post approval study for this style.   "
226567|NCT00811538|"     The clinical and radiological data of patients with an acute ischemic stroke treated with     intravenous thrombolysis (IVT) or intraarterial thrombolysis (IAT) in a Swiss stroke unit are     assessed in a Swiss Multicenter Thrombolysis Registry. Like in clinical routine, a clinical     evaluation takes place in a 3-months follow-up. Furthermore quality of life is assessed with     a standardized questionnaire. The aim of the registry is to compare the safety and efficacy     of IVT and IAT in patients with acute ischemic stroke. The registry also helps to improve     in-hospital-management of stroke patients.   "
226568|NCT00811551|"     zWedge is a clinical feasibility IDE study. The objective is to characterize the relationship     between intra-thoracic impedance measurements obtained from a CRT-D device and pulmonary     capillary wedge pressure (PCWP) measured via a right heart catheterization (RHC) acutely and     over time.   "
226569|NCT00811564|"     A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2%     brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin     analogue in glaucoma or ocular hypertension subjects   "
226570|NCT00811577|"     The purpose of this study was to determine the safety of AZX100 Drug Product and to determine     whether it was effective in preventing or reducing scars that were made from trocars     following arthroscopic shoulder surgery.   "
226571|NCT00811590|"     Pilot study, Open-label, Phase II study of Everolimus.      Objective:      To determine if Everolimus can diminish large gastrointestinal polyps in patients with     Peutz-Jeghers Syndrome.      Methodology:      Polyp size and number will be compared to baseline by FDG-PET and CT and 12 months after     treatment with Everolimus. Since this is a pilot study, the polyps prior to treatment will     serve as the controls.   "
226572|NCT00811603|"     The purpose of this study is to evaluate the rates of maternal and neonatal infectious     morbidity in gravid patients undergoing cesarean delivery. Specifically, the investigators     are examining whether the timing of antibiotic administration has any effect on rates of     maternal and neonatal infections, neonatal sepsis work-up and length of hospital stay.   "
226573|NCT00811616|"     OBJECTIVES:      The primary objective of this study is to assess the safety and efficacy of the Supralimus -     Core™ Sirolimus Eluting Stent in de novo native vessel obstructive coronary artery disease.      STUDY DESIGN:      This is a single centre, prospective study. Approximately 105 patients were enrolled in the     study. Patients were followed for twelve months post-procedure. All patients were to have a     repeat angiography at 8 months.      STUDY POPULATION:      The study population consisted of approximately 105 patients with de novo native vessel     obstructive coronary artery disease with no specific criteria. Patients from the daily     practice were included. Patients had to meet all eligibility criteria for inclusion into the     study.      ENDPOINTS:      The primary safety endpoint of the study is defined as Major Adverse Cardiac Events (MACE) at     30 days.      The primary efficacy endpoint is the in-stent binary restenosis rate at 8-month follow-up     determined by off-line Quantitative Coronary Angiography.      The following secondary efficacy endpoints were assessed        -  Angiographic success        -  Procedure success        -  Quantitative Coronary Angiography derived vessel parameters in-stent and 5 mm proximal          and 5 mm distal from the edge of the stent: acute gain, MLD, % DS, late loss, mean          diameter. In-stent pre-, post and at 8-month follow-up.        -  Clinically justified Target Lesion Revascularization (TLR) at 12 months      The following secondary safety endpoints were assessed:        -  MACE until 12 months        -  Device related SAEs until 12 months        -  Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after          30 days until 12 months)   "
226574|NCT00811629|"     sRAGE, the soluble form of the receptor for advanced glycation end products, is a novel     marker of alveolar epithelial type I cell injury, but is also involved in acute systemic     inflammation. The purpose of this observational prospective study is to determine whether     sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during     ALI/ARDS, regardless of associated severe sepsis or septic shock.   "
226580|NCT00817609|"     This study will determine if Angongniuhuang Pill (Composed of Niuhuang, Yujin, Xijiao,     Huangqin, Huanglian, Xionghuang, Zhizi, Zhusha, Bingpian, Shexiang, and Zhenzhu) will have a     better effect in restoring consciousness for patients who have suffered from an acute     ischemic stroke. The study is designed to look at both consciousness level and overall     recovery and recovery of motor function, for example muscle strength and coordination.   "
226581|NCT00817622|"     The purpose of this study is to evaluate efficacy and safety of EPA(Eicosapentaenoic     Acid)alone and with VitE in diabetic patients.   "
226582|NCT00817635|"     This study will assess the blood pressure effect, safety and tolerability of LCI699 compared     to placebo and eplerenone in patients with resistant hypertension.   "
226583|NCT00817648|"     The primary objective of this study is to evaluate the efficacy of seroquel in the treatment     of patients with acute schizophrenia compared with risperidone by evaluating the change of     PANSS total score from the baseline to week 6.   "
226584|NCT00817661|"     Influenza viral infection can cause serious illness among young infants 0-6 months of age.     However, inactivated influenza vaccine is not recommended for this age group but pregnant     women can be vaccinated during 2nd - 3rd trimester to induce passive immunization of their     infants. Nevertheless vitamin A deficiency is highly prevalent among pregnant women in     Bangladesh, >50% pregnant women consume less vitamin A than the recommended level. Given the     fact that both clinical and sub-clinical vitamin A deficiency impair vaccine specific     immunity, in this proposed study, we aim to investigate whether maternal vitamin A     supplementation improve influenza vaccine specific immune responses among pregnant women and     the passive protection of their infants.      In a placebo controlled clinical trial, sixty six mothers will be randomly assigned to     receive either 10,000 IU vitamin A or placebo capsules weekly from second trimester to 6     month postnatal period. At 26-28 weeks of gestation, all mothers will be vaccinated with     inactivated, trivalent influenza virus vaccine. Maternal and cord blood will be collected for     vitamin A and influenza virus specific IgG assessment. Colostrum and breast milk at 6-month     will be collected for vitamin A and influenza virus specific secretory IgA assessment. Venous     blood (2-3 ml) will be obtained from all infants at the age of 6 months for vitamin A and     influenza virus specific IgG assessment as well as infants' nasal swab for influenza virus     specific secretory IgA.   "
226585|NCT00817674|"     To test if usual at home night time sleep duration as measured with activity monitors and     questionnaires will predict changes in kidney function as measured by kidney filtration rate     and of cardiovascular function as measured by C-reactive protein in the blood. The study will     explore the role of decreased sleep time or decreased sleep quality as a non-traditional risk     factor for the progression of CKD and for the development of cardiovascular disease in CKD.   "
226586|NCT00817687|"     This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in     patients who have received a kidney transplant from an expanded criteria donor. Patients will     be randomized to one of two groups; the first group will have a biopsy at day 10, and the     second group will receive standard management. All patients will be given CellCept as     standard of care. The anticipated time on study treatment is 1 year, and the target sample     size is 100-500 individuals.   "
226587|NCT00817700|"     This project has 6 aims.        1. To examine the impact of recurrent partial sleep loss in young, middle-aged and older          men and women. Sleep will be restricted to 4 hours.        2. To test the hypothesis that extending bedtimes to allow for sleep recovery will reverse          the metabolic, endocrine, and cardiovascular and neuro-behavioral alterations resulting          from sleep restriction. Sleep will be extended to 12 hours following the 4 hour sleep          restriction.        3. To test the hypothesis that there are age and gender differences in the total amount of          sleep recovery obtained during the week of 12-hour bedtimes.        4. To test the hypothesis that there are age and gender differences in sleep capacity (the          amount of time an individual can sleep per night when there is no sleep debt).        5. To test the hypothesis that sleep capacity is partly determined by baseline levels of          slow-wave sleep and slow-wave activity.        6. To determine whether sleep capacity is related to sleep need by examining metabolic,          endocrine, cardiovascular and neuro-behavioral changes with the amount of the individual          sleep debt.   "
226588|NCT00817713|"     This study focuses on one of the major health issues of Sub-Saharan Africa: multi-parasitism     and co-infections. In particular this study aims to elucidate the interaction of helminths     with HIV.      There is good reason to suspect a detrimental effect of helminth infection on the course of     HIV infection. We hypothesize, that treatment of helminths in HIV- and helminth co-infected     individuals leads to a reduction of HIV viral load. With a lower HIV RNA level one would     expect a slower decline of CD4 cells and hence also a slower progression of the disease.     Ideally this would lead to a prolongation of the chronic phase of HIV infection and to a     delay in the time when anti-retroviral treatment needs to be started.   "
226589|NCT00817726|"     -  Purpose - to validate a combination of biological and clinical markers in the          rapid-eye-movement (REM) sleep behavior disorder (RBD) population as indicative of the          pre-symptomatic stage of Parkinson's disease (PD).        -  Procedures - All subjects (RBD diagnosis, PD diagnosis and controls) will have 1) a          medical and neuro history and physical including videotape of movements, 2)          neuropsychological testing, 3) a sleep study, 4) olfactory testing, 5) blood draw for          serum testing , 6) functional MRI, & 7) eye tracking test. All of these procedures are          often performed clinically in the diagnosis of PD. Any testing performed prior to          enrollment as part of the clinical evaluation may be used in place of repeating the          procedure for the study. Subjects will be followed for 5 years. It is hypothesized that          a 5 year follow up may capture a significant number of pre-Parkinson's subjects who will          be diagnosed.   "
226590|NCT00817739|"     This study is aimed at evaluating the effects of intermittent hormonal treatment with     complete androgen suppression (Leuprorelin 3.75 milligram [mg] sustained release [SR] and     Flutamide) in patients presenting with stage D2 or Tx Nx M1 ≠ M1a metastatic prostrate     cancer, with a prostate specific antigen (PSA) level 5-fold higher than normal (PSA greater     than or equal to [≥] 20 nanogram per milliliter [ng/mL], as quantitated by the Hybritech     radioimmunoassay) and with a subsequent decline to normal (PSA less than [<] 4 ng/mL) during     the initial 6 months of induction treatment. The results will be compared with those obtained     after continuous hormonal therapy with complete androgen suppression.   "
226591|NCT00817752|"     Ayurvedic medicine has been practiced in for more than 2,500 years. Ashwagandha is one of the     most widely utilized herbs in the system. It is thought to affect the endocrine, immune,     nervous, and cardiopulmonary systems. This study is designed as a preliminary investigation     of the effects of Ashwagandha on stress, inflammation, and immune modulation. Participants     will take the liquid extract in cow's milk twice a day for five days. The results of initial,     one-day, and final blood draws will be compared to determine participant's beginning and     ending levels of cortisol, inflammatory cytokines, and immune-cell activation (CD4 T-cells,     CD8 T-cells, B cells and natural killer cells). Measurements will be completed using flow     cytometry and ELISA assay. The purpose of this study is to determine which effects of     Ashwagandha are most suitable for further investigation.   "
226592|NCT00817765|"     The purpose of this study is to determine the influence of posaconazole on unboosted     fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers.A second objective is     to determine the safety of combined use of fosamprenavir with posaconazole in healthy     volunteers.   "
226593|NCT00817778|"     The purpose of this study is to assess the 1 month safety and tolerability after multiple     oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin   "
226594|NCT00817791|"     Animal studies have shown that preconditioning with hyperbaric oxygen can induce central     nervous system and heart ischemic tolerance. This study was designed to determine the     protective effect of hyperbaric oxygen preconditioning on brain and myocardium     ischemia-reperfusion injury during coronary artery bypass graft surgery.   "
226595|NCT00817804|"     The purpose of this study is to compare a new noninvasive ventilator to existing ventilators     already used for patient care.   "
226596|NCT00817817|"     This is an open-label, comparative, randomized, parallel, multicenter study in asthmatics to     determine whether the administration of dry powder inhaled mometasone furoate (MF) 400 μg in     a monodose capsule device would be comparable to administration of powder inhaled MF 400 μg     in a multidose device.   "
226597|NCT00817830|"     The purpose of this study is to assess the safety of lodenafil carbonate in patients with     coronaropathy, evaluating the response of the body facing physical effort, including both     heart and respiratory components, with and without use of lodenafil carbonate 80mg.   "
226598|NCT00817843|"     The purpose of this study is to investigate whether low-dose simvastatin in combination with     ezetimibe in comparison to high-dose simvastatin alone, has a beneficial effect on the     function of the endothelium after an oral fat load in patients with metabolic syndrome.   "
226599|NCT00817869|"     In hospitals, older people can fall and hurt themselves. The investigators want to see if a     new type of flooring can help stop people hurting themselves as badly, if they accidentally     fall.   "
226600|NCT00817882|"     Back pain has a major impact on people's ability to work. Health professionals need to know     how they can best use their limited resources to address the occupational needs of people     with chronic low back pain. Vocational rehabilitation is the process that helps people with     health problems to stay at, return to and remain at work. This study comprises the second     phase of a three year study of back pain and vocational rehabilitation. The first phase     gathered data from patient interviews and postal surveys of GPs and GP practice managers.     These findings have been used to inform this second phase; a feasibility randomised     controlled trial. The participants will be thirty employed people with back pain who have     been offered an NHS rehabilitation programme, and who are concerned about their ability to     work with low back pain. Those who consent will be randomised into two groups. One group will     receive routine rehabilitation. The other will receive routine rehabilitation plus an     individually tailored vocational intervention carried out by the researcher. Following the     trial, individual interviews will be carried out with each of the participants by an     independent researcher. An economic study will evaluate the possibility of measuring the     cost-effectiveness of the intervention. The hypothesis is that an enhanced vocational     intervention plus routine rehabilitation will be more effective in improving patients' work     ability than routine rehabilitation alone.   "
226601|NCT00817895|"     Hepatectomy is still the most important treatment for HCC.High recurrence rate mostly     influence it's prognosis, especially for the patient with tumor >5cm, multiple tumor and who     cannot accept R0 resection.Our retrospective study showed sustained released 5-FU implanted     into the liver incisal margin after tumor was resected could reduce the recurrence rate of     HCC after liver resection.According to this, we proceed this RCT to prospectively observe the     effect of sustained released 5-FU,and we also want to know whether combined with sustained     released cisplatin will get better effect in preventing the tumor recurrence,especially in     short time after liver resection.   "
226602|NCT00818467|"     Patients need vitamin D which is normally produced in the skin in response to ultraviolet     light from the sun. Vitamin D is important for calcium absorption and good bone health.     Physicians have been using sunscreens to protect patients from skin cancer and the aging     effects of sunlight for a least a half a century. Dermatologists have promoted sunscreen use     to restrict sunlight exposure especially in white Caucasians. If this behavior is done 100%     of the time when outdoors individuals may suffer from vitamin D deficiency. It is impossible     to influence persons' behavior to wear sunscreens all the time when outdoors. With the use of     sunless tanning agent (DHA), once a week, we can obtain a continuous sunscreen in the top     layer of the skin that will not wash off, can't be removed with soap and water, or removed by     perspiration. Under these circumstances we can answer the scientific question, will sunscreen     use inhibit the production of vitamin D in the skin?   "
226603|NCT00818480|"     This protocol is open to subjects previously enrolled in and who had completed a Phase I or     Phase II study administering YM155. Subjects who are receiving benefit from treatment with     YM155 are eligible after completing the previous study.   "
226644|NCT00819039|"     This two part study will determine the appropriate dosing regimen of aprepitant for the     prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to     17 years of age, by assessing pharmacokinetic parameters and monitoring safety and     tolerability of administered doses. Part I will be an open label investigation of a single     dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after     aprepitant dosing. Part II will be a double blind trial of participants randomized to receive     either aprepitant or ondansetron.   "
226605|NCT00818506|"     Studies show that depression is a risk factor for the development of coronary artery disease     (CAD). Furthermore there is an increased occurrence of depression in patients with CAD. Among     other mechanisms atherosclerosis is believed to play a central role regarding these notable     associations between depression and CAD. Moreover, patients with late onset major depression     have an increased number of small lesions found in the white matter of the brain, the     so-called white matter lesions. The main goal of this project is to examine if CAD is     associated with depression and/or white matter lesions. CAD is evaluated using coronary CT     angiography. Depression is evaluated using a semi-structured diagnostic interview. White     matter lesions are quantified using cerebral magnetic resonance.   "
226606|NCT00818519|"     The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg /     ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne     vulgaris over 6 treatment cycles.   "
226607|NCT00818532|"     To assess which commercially available measurement device is most accurate in measuring low     (< 1.0 D) degrees of corneal astigmatism.   "
226608|NCT00818545|"     The stratum corneum (SC) is the superficial layer of the epidermis situated at the interface     between the body and its outside environment. Its strategic position confers it a crucial     role of protection against aggressions. After disruption, the kinetic of cutaneous barrier is     slower in elderly comparatively to young subjects.      The purpose of this study is to investigate, by characterizing molecular events, the     effectiveness of ER4017 (Hydroxypropyltetrahydropyrantriol) to restore kinetic barrier     function after acute disruption of stratum corneum in ederly subjects.      10 male volunteers aged from 60 to 75 years are randomized to receive topical application of     ER4017 versus placebo on skin inner forearms twice a day during 3 months. After sequential     selloptape strips, epidermal samples of treated and control skin are removed under local     anesthesia, using a dermatome. Differential gene expression analysis is performed using micro     array techniques and quantitative RT-PCR.      treatment, randomized on the location, double blind, placebo control, internal control     subject, prospective study.   "
226609|NCT00818558|"     The aim of this study is, i) to assess the presence and the frequency of CTC in NSCLC     patients undergoing surgery by using cytopathological analysis after their isolation by size     (ISET method), and, ii) to correlate the presence of CNHC with pTNM stage, histological     subtype, and percentage of tumor cells present into the primary tumors.   "
226610|NCT00818571|"     This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal     impaired patients   "
226611|NCT00818584|"     This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates     with suspected candida infection   "
226612|NCT00818597|"     The purpose of this study is to investigate the effect of an extracorporeal application of a     bed-side bioreactor containing human donor granulocytes on the course and outcome of septic     shock in humans.   "
226613|NCT00818610|"     The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not     inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with     community-acquired pneumonia.   "
226614|NCT00818623|"     The purpose of this trial was to find an optimal dose for a new trial drug - degarelix     (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was     studied. Patients participating were treated with FE200486 on one occasion. Thereafter they     came in for visits following a specific schedule until blood samples showed that there was no     further effect.   "
226615|NCT00818636|"     ***Please note that this study does not offer comprehensive treatment program for alcohol     abuse or depression. Please do not contact the study staff if you are seeking psychological     treatment. Further, this study is only enrolling people who are clients at Career and     Recovery Resources, Inc., in Houston.      The hypothesis is that writing about feelings and thoughts will help people who are in group     treatment feel less depressed and abuse alcohol less.   "
226616|NCT00818649|"     RATIONALE: Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Giving bortezomib together with vorinostat may kill more     cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with vorinostat     works in treating patients with high-risk myelodysplastic syndrome or acute myelogenous     leukemia.   "
226617|NCT00818662|"     The purpose of this study was to evaluate the efficacy and safety of 2 doses of Immune     Globulin Intravenous (IGIV), 10% administered every 2 weeks as an intravenous (IV) infusion     compared with placebo in participants with mild to moderate Alzheimer's disease (AD).   "
226618|NCT00818675|"     This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC     who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS     mutant lung cancer. Following 8 weeks of open-label ridaforolimus lead-in there will be an     assessment of disease status. Patients assessed by the investigator to have stable disease     after 8 weeks will be randomized to double-blind treatment with ridaforolimus or placebo.     Patients assessed to have partial or complete response will continue on open-label     ridaforolimus. Patients assessed to have disease progression will be discontinued from study.   "
226619|NCT00818688|"     We performed a national cross-sectional and prospective large epidemiological cohort study in     patients with ST. Office- and hospital-based vascular medicine French practitioners enrolled     all consecutive patients with a symptomatic ST of the lower limbs at least 5 cm long     documented by compression ultrasonography. Follow-up was three months. All events were     adjudicated by a central committee.   "
226620|NCT00818701|"     The purpose of the study is to show that low dose recombinant BNP coupled with     phosphodiesterase V inhibition will improve renal dysfunction and promote relief of volume     overload in patinets with acute decompensated heart failure complicated by the cardiorenal     syndrome.   "
226621|NCT00818714|"     SBRT to deliver a boost dose to residual primary tumor after definitive doses of standard     EBRT have been delivered concurrently with chemotherapy.      Serum levels of TGF-Beta1 and correlation with SBRT toxicity.   "
226622|NCT00818727|"     SSRI treatment in adults was found to decrease bone density. The use of SSRI among pregnant     women with depression or anxiety is extendent and raising. The effect of bone density of the     infants was not yet evaluated.   "
226623|NCT00818740|"     The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 in healthy     volunteers.   "
226627|NCT00818792|"     Percutaneous coronary intervention (PCI) with bare metal stent (BMS) in patients with renal     insufficiency has shown unsatisfactory results. Indeed, drug-eluting stents (DES) might     reduce the incidence of restenosis and therefore of target lesion revascularization     procedures in these patients.      We therefore designed a prospective, randomized, multicenter, not-sponsored study to directly     compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent     (Xience V) and bare-metal stent (Vision) (both 2nd-generation DES and BMS, respectively),     both implanted in the same patient with multivessel disease and renal insufficiency in order     to obviate for the multiple and unpredictable characteristics of this high-risk population.   "
226628|NCT00818805|"     To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal     allergic conjunctivitis.   "
226629|NCT00818818|"     This study was designed to evaluate the effect of low doses of pentavalent antimony     (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65     years. The hypothesis is that older patients may have a positive response with a lower dose     of pentavalent antimony, avoiding the frequent adverse events observed with the standard     dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with     the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The     endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up     after treatment to avoid the impact of spontaneous cure as a confounding factor.   "
226630|NCT00818831|"     The purposes of this trial are:        -  To evaluate the toxicity and tolerability of QBI-139 in patients with advanced          refractory solid tumors.        -  To determine the maximum tolerated dose of QBI-139 in patients with advanced, refractory          solid tumors.      Patients will receive QBI-139 by IV infusion over at least one hour once weekly for three     weeks. Treatment repeats every 21 days in the absence of disease progression or unacceptable     toxicity.      Cohorts of 3 to 6 patients receive escalating doses of QBI-139 until the maximum tolerated     dose (MTD) is determined.   "
226631|NCT00818844|"     The purpose of this study is to compare the macular volume of patients treated with a 3-month     course of topical Nepafenac (0.1% solution) to patients treated with a placebo course     following epiretinal membrane surgery.   "
226632|NCT00818857|"     The purpose of this project is to improve cancer screening rates within practices serving     low-income minority patients   "
226633|NCT00818870|"     The study is designed to assess and compare the effect of Vecam 40/300, Vecam 20/300 and     Omeprazole 20 mg (a standard FDA approved GERD treatment) on the control of gastric pH.   "
226634|NCT00818883|"     The purpose of this study is to compare the antihypertensive effect of chlorthalidone vs     hydrochlorothiazide when each is used with azilsartan medoxomil, once daily (QD), in     participants with moderate to severe essential hypertension.   "
226635|NCT00818896|"     There is general agreement that thyroid gland function should be assessed in pregnant women.     When the gland produces too little thyroid hormone (hypothyroidism), all of the woman's     bodily functions slow down, and there are problems with her baby's development. Until now,     physicians have identified this problem on an individual basis (case-finding), but this     approach misses many of the cases. Our trial aims to replace case-finding with a routine     blood test that is highly effective at detecting hypothyroidism, thereby allowing treatment     to correct the deficiency. This approach can eventually be implemented throughout the United     States.   "
226636|NCT00818909|"     To evaluate the physical effect of SYSTANE QID in people that have moderate to severe dry     eyes and to establish doctor confidence to prescribe Systane.   "
226637|NCT00818935|"     The purpose of this study is to determine whether low and intermediate GI Caribbean foods are     effective in the management of type 2 diabetes.   "
226638|NCT00818948|"     This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose     escalation study, enrolling approximately 48 subjects. Part A of the study will enroll     subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3     cohorts. Part B of the study will enroll SLE subjects with GN into 3 cohorts. The purpose of     the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and     pharmacokinetics.   "
226639|NCT00818961|"     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop     the growth of cancer cells. It may also stop the patient's immune system from rejecting the     donor's stem cells. The donated stem cells may replace the patient's immune cells and help     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving a     monoclonal antibody, such as alemtuzumab, before transplant and tacrolimus and methotrexate     after transplant may stop this from happening.      PURPOSE: This phase II trial is studying the side effects of donor stem cell transplant and     to see how well it works in treating patients with high-risk hematologic cancer.   "
226640|NCT00818987|"     To determine if operative treatment of non operative management of these fractures is best.     Hypothesis: There is no difference in functional outcome between operative and     non-operatively treated 3- and 4-part proximal humerus fractures at one year's time.   "
226641|NCT00819000|"     The purpose of this study is to determine if higher compliance and adherence rates to drug     therapy for MS result in better health outcomes than lower rates of therapy compliance and     adherence.   "
226642|NCT00819013|"     This multi-center study will be conducted in the United States with up to 80 healthy adult     subjects. Subjects will be scheduled to receive a total of two (2) injections with 1     injection each administered.      Subjects will be randomized according to a randomization scheme.   "
226643|NCT00819026|"     Hepatitis C Virus is constantly evolving genetically, particularly in response to the immune     system. This is an observational study to examine if immunosuppressants particularly     calcineurin inhibitors taken by transplant patients in order to avoid organ rejection causes     predictable changes in the genetics of this virus that might be important in order to treat     it effectively.   "
226645|NCT00819052|"     The primary objective of this study is to demonstrate the efficacy of nevirapine extended     release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine     immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.   "
226649|NCT00819104|"     This is a randomised, open-label; parallel group, multicentric study comparing the efficacy     and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual     components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in     lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female     patients of essential hypertension aged between 18-80 years will be studied. The patients     should not have a history of prior cardiovascular disease.   "
226650|NCT00819117|"     The purpose of this study is to demonstrate that epicardial and transvenous left ventricular     leads are safe and effective for cardiac resynchronization therapy in heart failure patients     implanted with a CRT device.   "
226651|NCT00819143|"     Although allogeneic stem cell transplantation is curative in CML, evidence of the BCR-ABL     oncogene at low levels is still found in long-term follow-up of survivors. Such low levels of     BCR-ABL post-transplant which do not fulfill criteria for molecular relapse are monitored     regularly and considered to be suppressed by the GVL effect. Treatment with donor lymphocyte     infusions is only instituted when quantifiable BCR-ABL transcript levels rise steadily,     indicative of a true molecular relapse .      Similarly, BCR-ABL is still detectable in the majority of CML patients treated with imatinib     who achieve complete cytogenetic response, although the amount of BCR-ABL transcripts seem to     decline with longer follow-up. With 5 years follow-up of CML patients at CP who received     imatinib, the estimated cumulative best rates of complete hematologic response and complete     cytogenetic response were 98 percent and 87 percent, respectively10. For the minority of     CP-CML patients who do not respond satisfactorily to imatinib, second-generation tyrosine     kinase inhibitors are now the recommended next line of treatment.      A major question facing clinicians is whether imatinib and the other more pharmacologically     potent second-generation tyrosine kinase inhibitors;can suppress the CML clone at the     leukemic stem cell level as effectively as allogeneic stem cell transplantation. This     protocol is designed to scientifically compare the treatment responses of patients who are     treated with allogeneic stem cell transplantation with patients who receive imatinib or     second generation tyrosine kinase inhibitors.      The primary endpoint of this trial will be the proportion of patients who have detected     minimal residual disease (DMRD) in primitive CD34 plus progenitor subpopulations no earlier     than 60 days from the onset of their respective treatments.   "
226652|NCT00819156|"     The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing     six different doses. The patients participating in the trial were treated with degarelix     every month for a year. During the treatment the patients had to visit the clinic for     investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone,     follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed     throughout the trial.   "
226653|NCT00819169|"     This is a multi-center, 2-part phase 1b/2 study of AMG 655 in combination with AMG 479 to be     conducted in the United States and Spain.      Part 1 is a dose escalation segment to identify a dose of AMG 655 in combination with AMG 479     that is safe and tolerable.      Part 2 will evaluate the safety and estimate the efficacy of AMG 655 at the dose selected in     Part 1 in combination with AMG 479 for the treatment of patients with advanced NSCLC     (non-squamous histology; squamous histology), CRC, pancreatic cancer, ovarian cancer, and     sarcoma.   "
226654|NCT00819182|"     Background: Paced respiration has been internationally recommended for vasomotor symptom     management despite limited empirical evidence.      Objective: To evaluate efficacy of a paced respiration intervention against a sham comparator     breathing control and usual care control for vasomotor and other menopausal symptoms.      Design: A 16-week, 3-group, partially blinded, controlled trial with 2:2:1 randomization and     stratification by group (breast cancer, no cancer), Midwestern city and surrounding area.      Participants: 218 randomized women (96 breast cancer survivors, 122 menopausal women without     cancer) recruited through community mailings and registries.      Interventions: Training, home practice support, and instructions to use the breathing at the     time of each hot flash were delivered via compact disc with printed booklet (paced     respiration intervention) or digital videodisc with printed booklet (fast shallow breathing     control). Usual care control received a letter regarding group assignment.      Main Measures: Hot flash frequency, severity, and bother (primary), hot flash interference in     daily life, perceived control over hot flashes, and mood and sleep disturbances (secondary).     Intervention performance, adherence, and adverse events were assessed.   "
226655|NCT00819195|"     The purpose of this study is to determine whether glatiramer acetate (Copaxone) will induce     anti-inflammatory type II monocyte development during treatment of MS, and if these antigen     presenting cells (APC) will promote Th2 and Treg differentiation of naïve T cells.   "
226683|NCT00819572|"     The purpose of this study is to determine whether an intra-articular injection of DLX105 to     the knee joint of patients suffering from severly painful osteoarthritis is safe and reduces     pain.   "
226656|NCT00819208|"     RATIONALE: Participating in a physical activity program designed to increase free time     physical activity and receiving written health education materials may influence the chance     of cancer recurring as well as impact on physical fitness, psychological well-being and the     quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It     is not yet known whether giving a physical activity program together with health education     materials is more effective than giving health education materials alone for patients who     have undergone colon cancer treatment.      PURPOSE: This randomized phase III trial is studying a physical activity program given     together with health education materials to see how well it works compared with giving health     education materials alone for patients who have undergone treatment for high-risk stage II or     stage III colon cancer.   "
226657|NCT00819221|"     The study will be an open label, multicenter, dose finding study. Depending on the tolerated     dose up to 7 dose levels will be explored in this study, approximately 33 patients (21-54     depending on number of cohorts) may be enrolled into this study. Three patients will be     initially dosed in each cohort. The primary objective of this study is to determine the     recommended dose (RD) of twice daily oral doses of AZD2281 either as intermittent therapy for     7 days out of a 28-day schedule or given continuously, administered in combination with     liposomal doxorubicin to patients with advanced solid tumors.   "
227009|NCT00824356|"     This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of     two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an     allergen challenge chamber in male subjects with seasonal allergic   "
226659|NCT00819247|"     The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of     patients were treated for six months on different doses. The patients had blood samples taken     and measured for Testosterone in order to determine the most efficient dose to provide fast     and sustained castration. The patients came to the clinic for 16 visits and dependent on the     blood sample results they were invited to return for additional blood samples on a two weekly     basis.   "
226660|NCT00819260|"     Purpose: The aims of this randomized clinical trial are to assess and compare 3 different     outcomes in women undergoing breast reduction surgery using two different surgical devices:     the Harmonic Scalpel and electrocautery.      The three metrics are:        1. the time taken to complete the operation        2. drainage volume in the days immediately following surgery,        3. patient pain in the days immediately following surgery.   "
226661|NCT00819273|"     An observational, non-interventional, multi-centre study to provide further information on     the utility of test for a predictive marker by investigating the current prevalence of high     sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.   "
226662|NCT00819286|"     The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to     normal activity in open heart surgery patients who had their breast bone closed either with     wires or plates.   "
226663|NCT00819312|"     The purpose of this study is to evaluate the effectiveness in terms of prevention of     pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.   "
226664|NCT00819325|"     Patients with diabetes have worse outcomes after percutaneous coronary intervention (PCI)     procedures, compared to those patients without diabetes. They are at increased risk of death,     heart attack, or needing further procedures due to renarrowing of their coronary narrowings     after implantation of a coronary stent. Studies have suggested that poor control of diabetes     may be partly responsible for these poor outcomes. Thiazolidinedione drugs, such as     pioglitazone, can improve the diabetes control and make the patient more sensitive to the     effects of insulin. Preliminary studies suggest that pioglitazone may also help prevent     renarrowing after PCI.      This study was a pilot study designed to determine whether more aggressive treatment of the     diabetes with the routine use of the drug pioglitazone (30mg/day for 6 months), in addition     to the patient's usual diabetic medications adjusted to optimize their diabetic control (get     glycated hemoglobin < 7%), could reduce the amount of tissue buildup within the stent after 6     months, compared to a group less aggressively treated without pioglitazone and their usual     medications for diabetes.      An intravascular ultrasound probe was used to assess the extent of tissue buildup within the     stent and this was performed immediately after the PCI as a baseline and repeated after 6     months of therapy.      The investigators hypothesize that the more aggressive diabetic treatment with pioglitazone     would reduce the extent of tissue growth within the stent after 6 months of therapy.   "
226665|NCT00819338|"     The principal purpose of this study is to determine whether increased intakes of n-3     polyunsaturated (omega-3) fatty acids will reduce the amount of fat stored in the liver in     patients with non-alcoholic fatty liver disease.   "
226666|NCT00819351|"     The purpose of this study is to investigate if intramuscular PEG-asparaginase administered     either at six or two week intervals from day 92 until 8 months from diagnosis for patients     with non-HR ALL will result in equal probability of Event Free Survival   "
226667|NCT00819364|"     This is a randomized controlled study to determine whether the BCRI     (Behavior－Cognition－Relationship Intervention) model is effective for the autistic children.     BCRI model is a eclectic method using behavior modification, structure teaching,     relationship-focus approaches according to the symptom severity and main problems at any     stage of training for the autistic children. The BCRI Model emphasis the importance that     parents understand the principle of training and education and can use them skillfully,     appropriately and persistently.   "
226668|NCT00819377|"     Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac     surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows evidence of     being a pulmonary vasodilator able to possibly contribute to the reduction of pressure on the     pulmonary artery.   "
226684|NCT00819585|"     A 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled study to     evaluate canakinumab (ACZ885) for prophylaxis of signs and symptoms of acute flares in     chronic gout patients initiating allopurinol therapy   "
226891|NCT00822796|"     The purpose of this study is to determine if the Thermogard™ central venous catheter can     prevent hypothermia (defined as a core body temperature less then 36.0 °C) in severely burned     patients who are undergoing surgery for debridement and grafting in the setting of reduced     ambient room temperature.   "
226669|NCT00819390|"     HIV is characterized by frequent immune system activation. Early in the course of infection     the body establishes an immune activation set point related to the amount of HIV in the     blood stream. This set point affects the rate of CD4 cell loss. Without CD4 cells, or with     very low levels of CD4 cells, the body cannot fight off illness. This is known as     immunodeficiency. If left untreated HIV can lead to extreme immunodeficiency and AIDS.      Evidence suggests that by decreasing the rate of immune system activation, immune deficiency     progression could be prevented. The purpose of this study is to learn how well chloroquine     can reduce the level of immune activation and to test the safety and tolerance of chloroquine     in people infected with HIV.   "
226670|NCT00819403|"     To determine whether the combination of ezetimibe and simvastatin improves biomarkers of     atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.   "
226695|NCT00819741|"     This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood     sugar lowering effect of repaglinide plus metformin as initial treatment compared to     repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated     haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The     associated unfavourable events including low blood sugar episodes between the two treatments     are also compared.   "
226910|NCT00823056|"     Probiotics has been known as a dietary supplement for a long period. Recent clinical trials     indicate that probiotics might have an effect in preventing common infection diseases in     children.      The investigators hypothesis is: if young children in the age of 6 month to 15 mdr. has a     daily intake of a suspension containing probiotics in a period of 9 months, the incidence of     diarrhoea and respiratory diseases can be reduced.   "
226671|NCT00819416|"     Severe infection in the intensive care unit is common accounting for about 10% of admissions     and has a death rate of approximately 40-50%. It is almost always associated with significant     reductions in blood pressure. Administration of fluid often in large volumes is essential to     normalize blood pressure and prevent failure of organs and death. Two common classes of fluid     solutions are crystalloid fluids (salt based, normal saline) and colloid fluids (protein     based, albumin). Due to its properties, the albumin fluid may remain in the vascular space     better than the normal saline solution. Hence, there may be faster attainment of normal blood     pressure as well as a reduction in failed organs and death. Preliminary clinical trial data     suggests a potential for benefit with albumin in this setting but these findings require     confirmation in a large clinical trial.      There are few data to explain how albumin may exert its protective effects and lead to better     outcomes for patients with severe infections. We will conduct a clinical study that will     examine potential biological mechanisms for albumin's protective effects in 50 patients     across 6 Canadian academic hospitals. We will also examine our ability to successfully     recruit patients into this trial.      This study will provide information that will help to understand the biological mechanisms of     albumin in severe infection. The information gained will guide the investigative team for     future fluid related mechanistic questions. The study will also provide essential information     that will aid in the design and conduct of the future large clinical trial that will examine     death as its primary outcome.   "
226672|NCT00819429|"     This is a 36-week, randomised, double-blind, placebo-controlled trial. The overarching aim of     this study is to assess whether a nutritional intervention (Omega-3 supplement), when     combined with a more traditional treatment approach to conduct disorder and Attention Deficit     Hyperactivity Disorder (ADHD), is more effective than either approach alone in treating these     conditions in children and adolescents. The research questions cannot be answered through     alternative means because disruptive behaviour disorders are primarily childhood disorders.   "
226673|NCT00819442|"     The purpose of this study is evaluation of expression of desmin in cardiomyocytes of patients     with idiopathic dilated cardiomyopathy. Analysis of relationship between desmin expression     and activities of mitochondrium and expression of ubiquitin.   "
226674|NCT00819455|"     Type 2 diabetes is a major and increasing problem in India and the UK. In clinical trials it     can be prevented in people at high risk by lifestyle intervention. While these trials     established the proof of principle, they involved a degree of input from healthcare     professionals not feasible outside the trial situation. We hypothesize that diabetes     prevention can be achieved at lower cost using personalised feedback via mobile phone, based     on information on healthy diet and physical activity habits. We shall develop research     protocols and computerized algorithms to test this hypothesis in India for application     subsequently in the UK and elsewhere.   "
226675|NCT00819468|"     This is a study to compare the pharmacokinetic profile of teduglutide in healthy subjects     with normal hepatic function with subjects who have moderate hepatic impairment.   "
226676|NCT00819481|"     The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total     knee replacement surgery.   "
226677|NCT00819494|"     The purpose of this trial is to study the diagnostic role of skin test in immediate reactions     to iodinated radiocontrast media.   "
226678|NCT00819507|"     The purpose of this study is to determine the effect of short-term therapy using VANOS     Cream, a super-potent topical steroid cream on skin barrier function in patients with atopic     dermatitis. This cream is already approved for this indication, but the investigators will     further examine its effects on the skin barrier. This cream is a novel formulation of     fluocinonide designed to enhance compliance with a cream base, but have the skin barrier     repair properties of an ointment.   "
226679|NCT00819520|"     The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single     applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who     have recently used standard head lice treatments without success.   "
226680|NCT00819533|"     This study is designed to evaluate preliminary safety and accuracy of the ActiSight™ Needle     Guidance System in patients undergoing CT-guided lung aspiration or biopsy. This image     guidance system uses a combination of CT scans and camera images to help guide a biopsy     needle to a lung lesion. The system displays a simulated image of a biopsy needle and its     estimated path for the biopsy.   "
226681|NCT00819546|"     The purpose of this research study is to determine the safety of the combination of RAD001     and PKC412 as a cancer treatment, and to establish the highest dose of RAD001 that can be     given in conjunction with PKC412. These drugs have been used in other research trials for     individuals with solid and hematology malignancies. Past research on PKC412 shows that it     blocks the abnormal functioning of an enzyme called FLT3. FLT3 is found in your cells in     either a normal (wild type) or genetically changed form and plays a role in the survival and     growth of AML cells. RAD001 is an inhibitor of a central growth pathway that involves the     protein MTOR. The MTOR pathway is overactive in cancer cells, causing the cells to grow     abnormally. By inhibiting the abnormal growth activity of the MTOR pathway, RAD001 slows down     and possibly stops the growth of cancer cells.   "
226682|NCT00819559|"     Hypothesis        -  Pre operative radio-chemotherapy might be not mandatory to improve local recurrent rate          and survival rate in the mid-lower rectal cancer patients with T3N0 clinical stage, if          surgical principals were kept.        -  Laparoscopic resection is not inferior to Open surgery in the treatment of rectal          cancer.   "
226696|NCT00819754|"     Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are     associated with high response rates and long survival as first-line treatment for metastatic     colorectal cancer (mCRC). The oral fluoropyrimidine, capecitabine, is better tolerated and     shows better response rates than 5-FU/LV in metastatic colorectal cancer. A phase I     dose-escalation study established dose limiting toxicity (DLT), maximum tolerated dose (MTD)     and recommended phase II doses (RPIID) of irinotecan, oxaliplatin and capecitabine. This     phase I /II study is to determine dose-limiting toxicities (DLTs), maximum tolerated dose     (MTD), phase II recommended dose (RD) of IXO and bevacizumab combination and safety at the RD     in an expanded cohort.   "
226697|NCT00819767|"     This study compared the blunting effect of aliskiren and valsartan monotherapies on     exercise-induced rises in systolic blood pressure in patients with mild to moderate essential     hypertension.   "
226685|NCT00819598|"     Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD     are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is     the ratio of ankle pressure to arm pressure based on measurement of blood pressures in the     arms and legs using a Doppler device. The need for dedicated equipment and trained personnel,     along with the time required to perform the test, have been identified as barriers to     widespread implementation of ankle-brachial index screening. The use of automated     oscillometric devices for blood pressure measurement and determination of the ankle-brachial     index has been applied with variable success. It will be beneficial to investigate a reliable     oscillometric-based procedure that can accurately measure leg pressures for the     ankle-brachial index across the entire spectrum of PAD severity.      The purpose of this study is to determine the optimal oscillometric-based technique for     estimation of Doppler-derived systolic arm and ankle blood pressures for calculation of the     ankle-brachial index in patients with and without PAD.      Subjects with suspected arterial disease in the non-invasive lab will be enrolled. Arm,     ankle, and toe pressure measurements will be made in the supine position using Doppler,     oscillometric methods, and photoplethysmographic sensor. Arm and ankle pressures from a     subset of subjects will be obtained in both seated and supine positions. The ankle-brachial     index and toe-brachial index will be calculated.   "
226686|NCT00819611|"     The purpose of this study is to investigate whether working memory training improves     behavioral symptoms, neurocognitive performance, and neural functioning in young children     with ADHD.   "
226687|NCT00819624|"     The study has two goals. The first goal of the study is to compare two methods of     administering questions about pain and sleep interference. The two methods being compared are     a telephone based system and an electronic hand held diary. The second goal of the study is     to evaluate a daily diary to evaluate fatigue symptoms in patients with fibromyalgia.   "
226688|NCT00819637|"     The purpose of this study is to determine the best dose of nebulized arformoterol, a quick     onset but long acting beta agonist, for use in treating acute bronchospasm in asthmatics     presenting to the the Emergency Department. Also this study will evaluate the side effect and     safety profile of arformoterol when used in this situation.   "
226689|NCT00819650|"     The aim of this study is to analyze the therapeutic effect of adjuvant Licartin therapy after     resection.Patients receiving curative resection (R0) were randomized to postoperative     Licartin group and no Licartin group. The time to recurrence ,the overall survival as well as     the incidence of complications after therapy was observed to confirm the role of adjuvant     therapy of Licartin.   "
226690|NCT00819663|"     Anti-TNF therapy induces intestinal wall remodeling that correlates with clinical response     and can be detected in patients undergoing serial computed tomography enterography (CTE).   "
226691|NCT00819676|"     The aim of this study is to investigate the pattern of organic volatile compounds (VOCs) in     the exhaled breath detected by biosensors in adults with persistent mild asthma. The analysis     of VOCs detected by biosensors in asthmatic adults will be compared with that in a control     group of healthy subjects and with exhaled nitric oxide (NO).      Identification of breath VOC patterns may be a completely noninvasive new technique for     assessing airway inflammation. A device containing a series of nanosensors can be used for     breath analysis of VOC patterns through integration with a suitable algorithm for pattern     recognition.      Preliminary data indicate that exhaled breath patterns detected by biosensors in healthy     subjects are different from those in patients with asthma. In patients with asthma, analysis     of exhaled breath using biosensors will be compared with exhaled NO measurement for studying     a possible correlation with an independent method for assessing airway inflammation and with     spirometry for assessing a possible correlation with lung function.      Measurement of exhaled NO is a well-established, validated, and standardized method for     assessing and monitoring of airway inflammation in patients with asthma who are     steroid-naive. In patients with asthma, exhaled NO concentrations are correlated with blood     eosinophil cell counts and with airway hyperresponsiveness (AHR).      This study could contribute to the identification and development of a completely new     non-invasive technique for assessing airway inflammation with important implications for     diagnosis and therapeutic monitoring of patients with asthma.      Establishing the effect of anti-inflammatory drugs on breath analysis by biosensors in     patients with asthma is relevant for future studies aimed to use this technique in asthma     management.   "
226692|NCT00819702|"     Our broad goal is to help prevent child maltreatment (CM) by modifying pediatric practice to     be more responsive to important biopsychosocial needs of many children and families. Training     pediatricians to address key risk factors for CM, thereby enhancing parenting and family     functioning, reducing the risk for CM while helping ensure children's health and safety, are     accomplishing this. We are building upon the existing pediatric primary care system and     strengthen the training of pediatricians. The project also builds on our extensive research     and clinical expertise in CM and in prevention (Black & Dubowitz, 1999, Dubowitz et al.,     1998, 1999, in press; Dubowitz & Guterman, 2005, Gaudin & Dubowitz, 1997).      We have developed and implemented an enhanced model of pediatric primary care, taking     advantage of the enormous opportunities of the existing pediatric primary care system, with     its regular contact with young children and parents (Dubowitz & Newberger, 1989; Dubowitz,     1989, 1990; Green, 1994). Pediatricians typically devote over half their time to checkups,     focusing on prevention. There is increasing recognition that pediatric care must incorporate     aspects of parental and family functioning and collaborate with community resources (Academy     of Pediatrics, 1998; Green, 1994b). The broad goal of this project is to implement concepts     that have been embraced by the field of pediatrics, but have not been applied and tested.   "
226693|NCT00819715|"     The purpose of this study is to determine whether small for gestational preterm infants, have     delayed or decrease gastric motility compared to appropriate for gestational age preterm     infants.   "
226694|NCT00819728|"     The main purpose of the study is to determine the activity of the weekly combination of     docetaxel (Taxotere) and irinotecan in terms of response rate in subjects with advanced,     previously untreated, non-small cell lung cancer. It is also to determine the activity of     this combination in terms of response duration, time to progression, median survival, overall     survival, and percent one-year survival, as well as the side-effect and toxicity profile of     weekly Taxotere and weekly irinotecan.   "
226911|NCT00823069|"     Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the     area around your nose.   "
226700|NCT00819806|"     Subjects will receive immunizations every other week for 8 immunizations prior to clinical     and immunological evaluations. Patients will then receive immunizations every month up to one     year. Cyclophosphamide will be administered intravenously 3 days prior to the first     immunization, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations. Women and men >= 18     years of age with refractory metastatic malignancies that express NY-ESO-1 by RT-PCR or     immunohistochemistry. Alternatively, patients may be elected on the basis of serum     anti-NY-ESO-!-antibodies as detected by ELISA.      Primary Objective: To evaluate the toxicity profile of the regimens described in Section 1.6.      Secondary Objective: To detect and quantitate immune responses induced by the proposed     peptide vaccine or protein vaccine in association with CpG 7909 and cyclophosphamide. This     endpoint will be assessed by an IFN-y ELISPOT assay of NY-ESO-1-specific tumor-reactive CD8 +     T cells. We also will look for NY-ESO-1 tetramer CD8+ T cells, Delayed-type Hypersensitivity     (DTH), and NY-ESO-1-specific CD4+ T cell responses with ELISPOT assays and     cytokine-release-assays.      Tertiary Objectives: To evaluate tumor response in terms of clinical tumor regression and     progression-free interval. To evaluate the survival of patients treated with the regimens     described in Section 1.6.      The first 3 patients will be assigned treatment A. All three patients will be treated and     observed for one month. If no DLTs are observed in the first 3 patients, accrual to arm A     will be put on hold and accrual will continue with Arm B. However, if 1 DLT is observed in     Arm A, up to 3 additional patients will be treated on Arm A, until either 2 DLTs have been     observed, or 6 patients have been treated with just 1 DLT among them. If 2 DLTs are observed     in Arm A, the study will terminate and all treatments will be deemed intolerable. The same     principles apply to the cohorts treated on B-E: if the number of DLTs (after one month of     treatment) is zero, accrual proceeds to the next treatment group; if it is 1, accrual     continues with the same treatment for up to 3 additional patients; if it is 2, no patients     will be treated on the remaining treatment arms.   "
226701|NCT00819819|"     The study will identify a cohort of infants at risk for celiac disease that can be followed     on a long term basis for investigating the natural history the celiac disease based on the     pattern of early nutrition. The study will investigate possible early feeding patterns     including the timing of introduction to gluten that may protect at least in part from CD     development in at risk infants.   "
226702|NCT00819832|"     Phase 1 - Optimization Phase:      Primary Objective: The primary objective of Phase 1 of this study is to determine the time     point at which maximal Circulating Tumor Cell Burden (CTCB) occurs following standard     vertebroplasty and Kyphoplasty procedures relative to baseline CTCB.      Phase 2 - Comparison Phase:      Primary Objective: The primary objective of Phase 2 of this study is to determine the change     in CTCB from baseline to post-treatment as measured using the CellSearch™ Assay and to     compare the average change between treatment groups with and without the use of the Cavity     SpineWand.      Secondary Objectives:        -  To determine the change in self-reported pain level from baseline to post-treatment as          measured using the visual analogue scale (VAS) for spine pain and to compare the average          change in pain level between treatment groups.        -  To determine the change in pain status from baseline to post-treatment as measured using          the Brief Pain Inventory (BPI) and to compare the average change in pain status between          treatment groups.        -  To determine the change from baseline to post-treatment in the M.D. Anderson Cancer          Center Symptom Inventory (MDASI) and to compare the average change between treatment          groups.        -  To determine the change from baseline to post-treatment in time to walk a 50-foot          distance and to compare the average change between treatment groups.   "
226703|NCT00819845|"     Data on preventive therapy in Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy     (BMD) affected individuals without cardiac involvement are very limited and currently lacking     regard both ACE-inhibitors and Beta-Blockers in Becker Muscular Dystrophy and for the latter     even in Duchenne Muscular Dystrophy patients. Thus, the study aim is to compare the efficacy     of carvedilol vs ramipril on myocardial tissue properties and heart function, performing CMR     and myocardial Ultrasound Tissue Characterisation analysis.   "
226704|NCT00819858|"     The primary objective of this study is to determine to what extent provision with RUTF will     promote catch up growth in children following an acute uncomplicated episode of P. falciparum     malaria.   "
226705|NCT00819871|"     NFKB1 -94ins/del polymorphism has been reported to be associated with reduced promoter     activity of NFKB1 and several clinical diseases, but the clinical results cannot always be     replicated. Besides, mutate allele is associated with alleviated inflammation in ulcerative     colitis and some tumors, but aggravated inflammation in ARDS. The clinical value of this     polymorphism remains controversial. This study was performed to investigate the association     of NFKB1 -94ins/delATTG polymorphism with lung and/or kidney injury after cardiac surgery     with CPB.   "
226706|NCT00819884|"     The purpose of this study is to compare the 24-hour glucose profiles in diabetic patients     treated with metformin following once daily and twice daily oral dosing   "
226768|NCT00820729|"     The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of     patients with interstitial pulmonary disease.      The aim of this study is to estimate the frequency of an increased blood pressure in the     lungs among patient with interstitial pulmonary disease, and to evaluate the use of different     biomarkers in diagnosis of the condition.   "
226707|NCT00819897|"     The aim of this study is to evaluate the role of cognitive disorders and quality of life in     patients with CIS, considered as high risk to develop an MS, treated with interferon Beta.     This prospective observational study will include 120 patients, all treated and evaluated     annually with neurological extensive examination, ophthalmologic screening (OCT, OF, VEP,     VF), auto questionnaire about fatigue (musicol, ELIF), quality of life (SEP-59), and     conventional MRI.   "
226708|NCT00819910|"     The design of the study will be randomized, double blind trial, which will examine the     effects of Rosiglitazone on the fasting triglycerides (TG), high-density lipoprotein (HDL),     low-density lipoprotein (LDL), and plasma concentrations of apolipoproteins A-I, A-II, and     C-III as compared to Fenofibrate and placebo. This study will also assess the synergistic     effect of Rosiglitazone and Fenofibrate on the same parameters. Data from this study will     help clarify whether Rosiglitazone favorably impacts plasma lipid and lipoprotein     concentrations through improving insulin sensitivity and glycemic control, or by directly     influencing the synthesis of the apolipoproteins that are responsible for very-low-density     lipoprotein (VLDL) and HDL metabolism.   "
226709|NCT00819923|"     The purpose of the trial is to compare the safety and effectiveness of bio-active-stent (BAS)     and everolimus-eluting stent (EES) in patients presenting with acute coronary syndrome.   "
226710|NCT00819936|"     Summary Question: Does backward walking offer additional therapeutic value in patients after     aortic aneurysm surgery? Participants: The study of backward walking as an addictive     physiotherapy procedure was conducted in the group of 65 patients who underwent abdominal     aorta surgery. The patients were randomly divided into three subgroups and three various     models of physiotherapy were applied. Control group has only routine physiotherapy since     therapeutic group I and II have also walking exercises forward in group I and backward in     group II respectively.   "
226711|NCT00819949|"     Freezing of gait (FOG) is a common yet poorly understood motor symptom in persons with     Parkinson's disease (PD). Previous studies have shown that bilateral uncoordinated gait and     gait asymmetry are related to FOG, and that intensive treadmill training in PD patients can     improve gait. However, no group has yet studied the effect of robot-assisted gait training     (RAGT) on FOG. The primary aim of this study is to collect pilot data on the effect of     robot-assisted gait training in reducing episodes of freezing in PD.      Subjects with Parkinson's disease that experience freezing of gait will be recruited and     enrolled following informed consent and screening for eligibility. Each of the 10 training     session will last approximately one hour. Neurological evaluations, testing of gait     parameters, and quality of life assessments will be conducted. Participants will also be     asked to return for 1- and 3-month post-intervention assessments to see if the training has     any lasting effects. Approximately 10-20 subjects will be enrolled, and the study will last     up to 6 months.      Robot-assisted gait training will be conducted with the Lokomat (a treadmill with     supplemental robot-assistance for moving the hip and knee). We will monitor changes in     freezing by conducting various assessments.      There are approximately 1 million Americans with PD in the US. PD is a significant cause for     reduced functional ability and quality of life, progressive disability. Patients with PD with     FOG have indicated that this is one of their most disturbing symptoms, as there are no     effective treatments. Therefore it is important that additional and alternative interventions     for FOG be tested and developed.   "
226712|NCT00819962|"     Perioperative analgesia using US guided TAP block   "
226713|NCT00819975|"     Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular     risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates     profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little     information exists about the effect of proteins.      The purpose of this study is to compare the effects of the milk proteins casein, Whey     Isolate, Whey Hydrolysate, and Alphalact-Albumin on postprandial lipid and incretin responses     to a high-fat meal in type 2 diabetes.   "
226714|NCT00819988|"     The purpose of this study is to determine whether administration of pregabalin by mouth     immediately preoperatively and three times daily for 3 days after surgery reduces the     incidence of delirium postoperatively and improves overall pain control.   "
226715|NCT00820001|"     This continuation study evaluates the long-term outcomes of multimodal, modular interventions     with early-onset behavior disordered children and innovative methods to promote the     maintenance and extension of treatment effects relating to ODD and CD. All participants     originally enrolled in the parent clinical trial are being followed and those who initially     received clinic or community based intervention from a study clinician were randomly assigned     to either Booster or No-booster treatment condition. The treatment-as-usual (TAU) and Healthy     Control participants were also followed through long-term follow-up assessments paralleling     clinically referred participants. The study examines the short and long-term efficacy of     booster treatment on clinical outcome, contextual variables, and service satisfaction/use.   "
226716|NCT00820014|"     The purpose of this study is to determine whether ESBA105, a single-chain (scFv) antibody     against TNF-alpha, efficiently penetrates into the anterior chamber and the vitreous body     upon topical administration to the eye.   "
226717|NCT00820027|"     The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to     placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total     knee replacement surgery.   "
226718|NCT00820053|"     The aim of this study is to analyze the therapeutic effect of adjuvant TACE after     resection.Patients receiving curative resection (R0) were randomized to postoperative TACE     group and no TACE group. The time to recurrence ,the overall survival as well as the     incidence of complications after therapy was observed to confirm the role of adjuvant TACE.   "
226719|NCT00820079|"     Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal     reflux.   "
226720|NCT00820092|"     1. To investigate the safety and tolerability of Xerecept during and following a 24-hour          intravenous administration to healthy Japanese to healthy Japanese and Caucasian          subjects        2. To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept          administration between healthy Japanese and Caucasian subjects   "
226721|NCT00820105|"     Evaluation of ADX10059 to prevent migraine attacks   "
238242|NCT00975143|"     The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a     marketed (generic) formulation of isotretinoin when both are administered twice daily with     meals.   "
226722|NCT00820118|"     The primary objective of the trial is to assess the ability of an early and intermittent     antiretroviral therapy in maintaining an immunological stability in antiretroviral naive HIV     infected adults, to offer a potential alternative strategy to differed and continuous     antiretroviral treatment.This is a 2-year phase II, open-label, multicentric proof of     concept trial. The patients included are treated following a pulse-therapy scheme, i.e.     6-month periods with once daily boosted-PI based therapy in alternance with 6-month periods     without antiretroviral therapy. The preferentially recommended treatment of the study is     atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and     lamivudine or emtricitabine + tenofovir.The patients are closely followed to assess the     efficacy and the tolerance of the strategy, with clinical, biochemical, immunological,     virological and pharmacokinetic evaluations.   "
226740|NCT00820365|"     This is an exploratory, open-label, uncontrolled, multi-center, 1-arm study conducted at 16     sites in Bulgaria, Germany and Romania.      A total of ca. 30 - 35 patients will receive SC12267 (4SC-101) tablets, 35 mg once daily for     12 weeks. First of all the patients will undergo a screening period of 1 week and a follow-up     visit will be performed 4 weeks after study drug discontinuation or earlier in case of     relapse during follow up. Total study duration will be up to 36 (+2) weeks.      There will be 8 study visits: one screening visit, 6 visits during the treatment period and     one follow-up visit. In addition, four telephone visits will be performed at Week 6, Week 10,     Week 20 (+1) and Week 36 (+2).      The duration of the entire study (first patient in till last patient out) is expected to be     about 13 months.   "
227010|NCT00824369|"     The purpose of the protocol is to assess long-term safety and tolerability of subjects who     discontinue for any reason from UK-453,061 qualifying studies.   "
226723|NCT00820131|"     Chronic pain after inguinal hernia repair has become a major concern. Although tension-free     Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40     % of patients complain of some kind of pain even one year after surgery. The necessity of     mesh-fixation using sutures, could be causative. However, current data do not provide     evidence whether suture fixation in Lichtenstein repair might be the reason for chronic     postoperative pain.      A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal     hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid     gripping system. Thereby the rate of chronic postoperative pain could be decreased.      Two techniques of inguinal hernia repair will be evaluated:        1. open anterior mesh repair using conventional Lichtenstein technique (sutures for          mesh-fixation)        2. open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for          mesh fixation)      Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at     the 10th day, as well as 3 and 15 months postoperatively.   "
226724|NCT00820144|"     It is a biomedical research without direct individual benefit, exploring and comparing the     mucosal immune response after oral, nasal and sublingual administration of B-subunit of     non-toxic cholera toxin (CTB) in healthy adult volunteers.   "
226725|NCT00820157|"     The aim of this study is to compare the surgical outcomes of cytoreductive surgery followed     by Transarterial Chemoembolization (TACE) with TACE alone in patients with MNHCC so as to     establish a treatment standard for MNHCC.   "
226726|NCT00820170|"     The purpose of this study is to find the highest dose of dasatinib that can be safely given     to a patient when the drug is given in combination with the known anticancer drug paclitaxel.     Paclitaxel is an established anti-cancer drug, used in the treatment of many cancers, and it     is an approved treatment for breast cancer. Dasatinib has been approved by the Food and Drug     Administration for use as a single therapy in another kind of cancer, but its use in breast     cancer patients, and in combination with paclitaxel is investigational.      In this study, we will test the safety of dasatinib when given at different dose levels in     combination with paclitaxel. We want to find out what effects, good and/or bad, it has on the     patient and on metastatic breast cancer.   "
226727|NCT00820183|"     The study hypothesis is that the implementation of a plan for quality improvement at the     primary care health teams taking care of hypertensive patients, will increase the level of     blood pressure control among those patients.   "
226728|NCT00820196|"     Venous leg ulcers are a common, costly and debilitating condition, with few effective     treatments. Compression bandaging helps healing, but more than four out of every ten leg     ulcers remain unhealed after three months. New treatments to help heal venous ulcers are     urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed     by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a     wound. Further research will be undertaken to assess the safety and activity of Nexagon® when     applied to venous leg ulcers in humans, and to obtain further information on the most     appropriate dose or doses to apply. A proposed randomised controlled trial aims to further     evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous     leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no     medication) to be applied to their ulcer three times over four weeks. Participants will be     followed up for 12 weeks to evaluate ulcer healing.   "
226729|NCT00820222|"     This open label study is designed to evaluate Lapatinib effect on incidence of brain     metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior     taxanes or anthracyclines.   "
226730|NCT00820235|"     The primary objective is to compare the gum response to three different dental implant     designs when placed in the front region of the upper jaw. The changes from baseline to one     year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes     from baseline to one year after are equal for all three implant-abutment interface settings.   "
226731|NCT00820248|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy in higher doses over a shorter period of time may kill more tumor cells and have     fewer side effects. Drugs used in chemotherapy, such as cisplatin, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. It is not yet known whether giving     standard radiation therapy together with high-dose cisplatin is more effective than giving     higher-dose radiation therapy together with panitumumab in treating patients with locally     advanced head and neck cancer.      PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens to see     how well they work when given together with cisplatin or panitumumab in treating patients     with locally advanced stage III or stage IV head and neck cancer.   "
226769|NCT00820742|"     An open label, non-comparative, multicenter, non-interventional, post marketing surveillance     study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the     treatment of Filipino patients with neovascular age-related macular degeneration based on     incidence of adverse events and to evaluate the efficacy based on visual acuity, and the     patient's and physician's overall satisfaction with tolerability and efficacy.   "
227540|NCT00830804|"     The purpose of this study is to assess the effectiveness and safety of an antiretroviral     therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as     first-line therapy in treatment-naïve participants.   "
226755|NCT00820560|"     To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28     days and to determine if a higher MTD can be established when INCB007839 is administered in     combination with prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment     interruption every two weeks.   "
226756|NCT00820573|"     In patients with type 2 diabetes with inadequate glycemic control on diet and exercise after     6 weeks of treatment:      Objective: To assess the effects of co-administration of sitagliptin and metformin compared     to placebo on hepatic glucose production (HGP).      Hypothesis: After 6 weeks of treatment, the co-administration of sitagliptin and metformin     provides greater reduction in hepatic glucose production (HGP) compared to placebo.   "
226732|NCT00820261|"     Rotavirus is the most common cause of severe infantile diarrhoea disease in infants and young     children below five years worldwide. It is associated with high cases of morbidity and     mortality and it is estimated that up to 600,000 deaths in young children occur annually in     the less developed countries and approximately 150,000-200,000 deaths occur in Africa alone.     In Kenya, most rotavirus surveillance work has been done in Nairobi (an urban setting). Other     parts e.g eastern Kenya, limited data is available and hence the prevalence and burden of     rotavirus disease is under-estimated. We therefore hypothesize that rotavirus prevalence is     high in Meru,Maua (a rural setting)and hence we designed a study to evaluate this.      This is a prospective study to determine, the rotavirus disease burden and epidemiology in     infants and children with severe diarrhoea hospitalized in three sentinel hospital in the     eastern part of Kenya (Maua Methodist hospital) will be carried out during the period January     2009 to December 2010.      Faecal samples will be collected from infants and children admitted with acute diarrhoea and     screened first for the presence of human serotype A rotavirus antigen using commercially     available enzyme linked immunosorbent assay kit (ELISA).      The positive samples will be evaluated by sodium dodecyl polyacrylamide gel electrophoresis     (SDS-PAGE) to determine the electropherotypes and genotyped using reverse transcriptase     polymerase chain reaction (RT-PCR) on VP7 and VP4 gene.      These data/ results generated from this project will add crucial information on the rotavirus     strains circulating in the eastern part of Kenya.   "
226733|NCT00820274|"     To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment     of resistant vascular ulcers.      To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement     of quality of life.      To evaluate rate of amputations and recurrence at one year after complete cicatrisation   "
226734|NCT00820287|"     Testis cancer with germ cells is the most frequent cancer of young men and its incidence is     in constant increase in many industrialized countries, as in France. An increased risk of     developing testis cancer has been described in patients with testicular ectopia history and     testicular cancer history (controlateral testicular cancer) and more recently suggested in a     population of hypofertile men with altered spermatogenesis. To a better understanding of this     risk, an attempt of characterization of this group of patients has been proposed in the     present work.      The general objective of this project is to characterize morphological and molecular markers     of hypofertility which could serve as predictive markers of testis malignant transformation.      In this project conducted in 3 establishments, the investigators propose:        -  To select a population of hypofertile patients exhibiting compatible clinical and          morphological characters with a high risk of testis tumoral transformation (secretory          azoospermia and/or a history of testicular ectopia. To determine the spermatogenic          arrests on histological criteria (score of Jonhsen).        -  To study the expression of four proteins or family of proteins suspected of being          involved in testis tumorogenesis such as: the Placenta Alkaline Phosphatase (PLAPE),          cyclin A1, VASA and connexin (Cx) by immunohistochemistry and by real-time quantitative          RT-PCR analysis real-time analyses.        -  To establish a possible correlation between the clinical data, spermatogenesis arrest          and the expression of these biomarkers.      These approaches would allow to identify, in this population of hypofertile patients,     subgroups of men who could develop tumours with germ cells, and subsequently to propose     potential biomarkers for testis cancer. A more clinical observation of these subgroups will     be also proposed.   "
226735|NCT00820300|"     The purpose of this study is to determine if the Punctal Plug Delivery System is safe and     effective in controlling intraocular pressure in patients with ocular hypertension or     open-angle glaucoma.   "
226736|NCT00820313|"     The primary aim of the proposed research is to examine the relationship of lifestyle changes     to new dietary, biomedical, and cellular parameters among new enrollees entering the Dr.     Dean Ornish Program for Reversing Heart Disease program at 5 selected sites. Specifically,     the investigators will add assessments of emerging cardiac risk factors (e.g., high     sensitivity C-reactive protein [hsCRP], fibrinogen, lipoprotein(a) [Lp(a)], small, dense LDL,     apolipoprotein B [apoB], apolipoprotein A-I [apo A1], the apoB/apoA1 ratio, homocysteine     [Hcy], B-type natriuretic peptide [BNP], oxidized LDL, fasting insulin and waist-to-hip ratio     [WHR]), protective and pathogenic dietary markers (e.g., folate, carotenoids, trans fatty     acids), and measures of social support and cognitive functioning to the already existing     assessment variables in the Multisite Cardiac Lifestyle Intervention Program (MCLIP).      Hypothesis 1: Participation in the lifestyle program will not only be associated with     favorable changes in standard coronary risk factors and quality of life, but also with     improvements in emerging cardiac risk factors [hsCRP, Hcy, BNP, fibrinogen, Lp(a), small,     dense LDL, apoB, apoA1, oxidized LDL, fasting insulin, and abdominal obesity] and     psychosocial well-being (i.e., social support, and cognitive functioning).      Hypothesis 2: High intake of emerging protective dietary factors and low intake of emerging     pathogenic dietary factors will be associated with improvements in both standard and emerging     cardiac risk factors (e.g. Hcy, oxidized LDL).      Hypothesis 3: Degree of adherence to the lifestyle change program will be associated with     differential improvement in standard coronary risk factors, emerging risk factors, cellular     aging, and psychosocial variables.   "
226737|NCT00820326|"     This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by     intravenous way once a day during a 4 days Hospitalization.      This study is double blind (neither you nor the physician will know if you are receiving     active study drug or placebo).      Randomisation at the beginning of the study will decide whether you receive active treatment     or its placebo.      This treatment will be renewed after one month, after 2 months and after 3 months.      If the study staff determines that you are eligible and you decide to participate, there will     be approximately 6 study visits in about 9 months. During these visits, you will undergo     routine health exams and complete different kinds of questionnaires.      Following this first period of 3 months, you agree to come back for consultation at month 4,     month 6 and month 12 for monitoring and evaluating the effects of treatment.   "
226738|NCT00820339|"     To confirm that SHVE is a safe and effective procedure and it can prevent bleeding of the     hepatic vein. To evaluate the recurrence and metastasis in HCC patients undergoing     hepatectomy by SHVE.To evaluate that SHVE can improve survival in HCC patients or not.   "
226739|NCT00820352|"     Heart failure is a major medical and socioeconomic problem in western industrial countries,     especially with aging populations. Heart failure with normal left ventricle systolic function     (heart failure with preserved ejection fraction, HFPEF, heart failure with normal ejection     fraction, HFNEF) are common causes of hospitalization mainly in the elderly population and     are frequently associated with pulmonary hypertension. It is commonly seen, that patients     with left heart disease and pulmonary hypertension with right ventricle dysfunction have a     worse prognosis.      The investigators hypothesize, that an additional treatment with Bosentan in this patients     will improve their exercise capacity, symptoms, hemodynamics and quality of life.   "
226741|NCT00820378|"     Aortic aneurysms are the major disease processes affecting the aorta and becoming a     relatively common cause of death because of rupture or dissection. The most common location     for aneurysms is the infrarenal abdominal aorta, followed by the ascending thoracic aorta.     Unlike coronary heart disease, the incidence of abdominal aortic aneurysm (AAA) in the United     States and Europe has been increasing, and this increase may not be due to higher levels of     screening for this condition alone. Aortic diameter is central to the diagnosis of aortic     aneurysm. Furthermore, it was demonstrated that non-AAA patients with an enlarged diameter of     the infrarenal aortic diameter are also at high risk for all-cause mortality. And aortic root     dimension was associated with several coronary artery disease (CHD) risk factors and measures     of subclinical disease and was predictive of incident congestive heart failure (CHF), stroke,     cardiovascular disease (CVD) mortality, and all-cause mortality, but not of incident MI. Up     to now, there are limited studies on the epidemiology of aortic diameter, especially in     Chinese population.   "
226742|NCT00820391|"     The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation     protocol in treating traumatized children in Sri Lanka when applied by locally trained     teacher counsellors.   "
226743|NCT00820404|"     The purpose of this study is to evaluate the safety, and tolerability of single doses of     BLI-489 administered intravenously in healthy subjects, and also how the drug is absorbed and     eliminated.   "
226744|NCT00820417|"     This is an open-label, phase 1, non-randomised, non-controlled trial, carried out in two     centres on patients with advanced cancer expressing EGFR. Primary objective is the     determination of the maximum tolerated dose (MTD) and recommended dose (RD) of the     combination of intravenous Cetuximab and oral Gefitinib.   "
226745|NCT00820430|"     The objectives of this study are: to identify and develop techniques to minimize precision     errors in magnetic resonance imaging (MRI) evaluation of knee cartilage, and to determine if     results from newly-identified MRI techniques in measuring cartilage changes and structure can     be reproduced.   "
226746|NCT00820443|"     The purpose of this study is to demonstrate non-inferiority of the Ceramic on Metal Total Hip     when compared to a TRANSCEND® historical control group of patients with primary total hip     replacement.   "
226747|NCT00820456|"     The objectives for this study include:        -  Testing a unique way of imaging people with colorectal cancer and other cancers that has          spread to the liver using magnetic resonance imaging (MRI);        -  Seeing if the MRI process can be used across multiple imaging platforms;        -  Determining whether the results of the imaging can be reproduced;        -  Reviewing how MRI results relate to cancer response to combination therapy and to          clinical endpoints.   "
226748|NCT00820469|"     Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune     disorders. In some cases such as treatment of humoral acute rejection of renal transplant,     thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often     associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by     plasma exchange but the knowledge is poor in this matter.      The aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of     rituximab.      The results of this study should conclude if plasma exchange leads to a significant decrease     of plasma concentration of rituximab or not, and if the decreased of the concentration is     associated with a decrease in efficacy.   "
226749|NCT00820482|"     The present study aims to elucidate if the FSH and LH activity contained in hMG preparations     is comparable to the recombinant FSH and LH administration in a 1:1 ratio. The mean outcome     is the corresponding ovarian response in terms of oestradiol increase during stimulation and     number of mature follicles the day of hCG administration. The patients will be included and     randomized into two groups and stimulated either by HMG injections started on day 3 at a dose     of 75 IU every day and fixed for the first 5 days, and in the second group, rFSH and rLH     injections be started on day 3 at a dose of 75 UI/day of rFSH + 75UI/day of rLH. Serum     estradiol levels will be measured on stimulation day 1, day 6 and the day of hCG injection.     All follicles greater than 14 mm of diameter will be recorded on hCG day Intrauterine     insemination is performed during two consecutive days starting the day after the human     chorionic gonadotrophin (Ovitrelle) injection. Secondary outcomes are Days of stimulation,     Total doses of gonadotrophins administrated, Clinical pregnancy , Ongoing pregnancy and     Miscarriage rate, and Cancellation rate.   "
226750|NCT00820495|"     The purpose of this record is to test whether (a) participants who receive a Web-based     smokeless tobacco cessation intervention will be more likely to be abstinent than     participants who do not receive this intervention, and (b) whether participants who receive a     telephone quitline intervention will be more likely to be abstinent than participants who are     not in a quitline intervention.   "
226751|NCT00820508|"     The purpose of this study is to determine whether the histone deacetylase inhibitor CHR-2845     is tolerated in patients with haematological diseases and lymphoid malignancies.   "
226752|NCT00820521|"     The purpose of this study is to assess the safety and tolerability of ascending single oral     doses of GAP-134 in healthy subjects, to provide the initial pharmacokinetic profile of the     oral formulation of GAP-134 in healthy subjects, and to evaluate the effect on the     pharmacokinetic profile of a high-fat meal of 450 mg of GAP-134 administered to healthy     subjects.   "
226753|NCT00820534|"     Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours     in preventing the appearance of classical lesions following prodromal symptoms (tingling or     burning sensation) based on thermographic assessment among recurrent cold sore sufferers.   "
226754|NCT00820547|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make     the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving     bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after     surgery.      PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before     surgery and bevacizumab and radiation therapy after surgery to see how well it works in     treating patients with inflammatory breast cancer.   "
226758|NCT00820599|"     A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating     the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; study valve), its     transfemoral delivery system, and crimper accessories. The trial includes a premarket     confirmatory cohort to evaluate the system performance as well as a Post Market Clinical     Follow-up phase involving expanded enrollment and long-term follow-up of all patients to     evaluate valve performance out to 5 years.   "
226759|NCT00820612|"     Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic     retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of     disorders of the pancreas and bile duct.      Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered     rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to     definitively determine whether rectally administered indomethacin (a non-steroidal     antiinflammatory drug)is effective at preventing pancreatitis after ERCP.   "
226760|NCT00820625|"     The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase     from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition     to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing     persistent AF.   "
226761|NCT00820638|"     Up to 25 subjects will use the Myomoe100 in the home setting under the distant supervision of     an occupational therapist. We will look to see if they can perform functional activities     safely without adverse events.   "
226762|NCT00820651|"     The purpose of the study is to evaluate whether the addition of Diamel, a nutritional     supplement, to hypocaloric diet and exercise could improve the histological results     (steatosis, necro-inflammatory activity and fibrosis), insulin resistance, aminotransferase     levels and anthropometric measures in comparison with a placebo-controlled group with     hypocaloric diet and exercise during 52 weeks of treatment in patients with nonalcoholic     steatohepatitis.   "
226763|NCT00820664|"     The purpose of this study is to examine the effect of two different dose levels of estrogen     or placebo in healthy postmenopausal women by measuring the changes in hormone levels and     examining the changes in the uterine lining (endometrium).   "
226764|NCT00820677|"     This is a randomized, controlled trial to test the use of an educational video during the     newborn well-child visit. Parents who watch the video during their medical visit will be     compared to those parents who receive traditional paper handouts. Measures obtained at     baseline and 2-week follow-up include knowledge of infant development, self-efficacy with     infant care, and problem-solving skills.   "
226765|NCT00820690|"     The purpose of this study is to analyze gene expression signature and immunohistochemical     markers associated with clinical and pathological response to neoadjuvant chemotherapy in     locally advanced breast cancer.   "
226766|NCT00820703|"     Diabetic foot ulcers are sores on the feet that occur in 15% of diabetic patients some time     during their lifetime. Once an ulcer develops, the risk of lower-extremity amputation is     increased 8-fold in people with diabetes. New treatments that improve the number of ulcers     that heal and/or speed up healing are urgently needed. Initial studies with a new drug called     Nexagon® (developed by CoDa Therapeutics, Inc.) support the concept that healing of diabetic     foot ulcers can be improved with topical application of Nexagon®. Further research will be     undertaken to assess the safety and activity of Nexagon® when applied to diabetic foot ulcers     at various doses. A proposed randomized controlled trial will randomly allocate (e.g., by the     toss of a coin) 24 people with diabetic foot ulcers to Nexagon® (one of three different     doses) or vehicle (substance containing no medication) to be applied to their ulcer three     times over four weeks. Participants will be followed over four weeks to monitor their     response to the treatment, specifically with regards to the amount of healing that occurs.   "
226767|NCT00820716|"     The aim of the study is to compare two methods of exercise training: alternate load versus     constant load realized at moderate or high intensities, in order to define the interests and     the limits of each one of these two methods. The finality is to make possible to the expert     to choose what exercise training induces the best results quickly and to make its choice     according to the therapeutic objectives which it lays down.We also evaluate the effects of     these exercises training on the vagal response and the bronchial tone of the asthmatics. From     a clinical point of view, a close attention will be paid to the effects of these exercises     training on the control of asthma and the quality of life of the subjects   "
227561|NCT00831077|"     The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 and     ORM-14540 in healthy volunteers.   "
226770|NCT00820755|"     This open-label, randomized, multinational, non-comparative, phase IIIb trial with 2 parallel     groups will screen about 1400 subjects with stage IIIB non-small cell lung cancer (NSCLC)     with pleural effusion or stage IV NSCLC. It is expected that of approximately 1200 (85     percent) subjects who will be included, about 1000 will be Caucasian; about 120 Asian, and     the remainder (about 80) will be of other ethnic origin (that is neither Caucasian nor     Asian). Approximately 480 (40 percent) subjects are expected to be free of progression at the     end of combination treatment with cetuximab and platinum-based chemotherapy. These subjects     will be eligible for randomization to intravenous cetuximab maintenance therapy with either     500 milligram per square meter (mg/m^2) every 2 weeks or 250 mg/m^2 weekly (q1w); about 240     subjects are expected per group.      The trial will be performed in a community practice setting, with approximately 230 centers     participating in the trial worldwide (planned countries are Argentina, Australia, Austria,     Belgium, Brazil, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hong Kong,     Hungary, India, Ireland, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Russia,     Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey, United     Kingdom and Venezuela). With noncompetitive enrollment, approximately 4 to 8 subjects are     expected to be enrolled at each center. Enrollment in the individual centers is generally     limited to a maximum of 8 subjects. If any of these subjects does not receive trial treatment     for any reason or discontinue all trial treatment at the first visit, additional subjects may     be enrolled until 8 subjects were treated. The primary endpoint of the trial will be overall     survival time from inclusion into the trial to death. Additional secondary efficacy endpoints     will be time to treatment failure, tumor response, and disease control rate. Other endpoints     will include safety and toxicity, compliance with maintenance therapy, subject satisfaction     and translational research (TR) (for subjects with tumor samples available).   "
226771|NCT00820768|"     To determine MTD and DLT of ABI-010 given weekly every three weeks followed by one week of     rest (Cycle 1). Determine MLD and DLT in combination with ABI-007; to characterize the     toxicities of ABI-010 alone and in combination with ABI-007.   "
226772|NCT00820781|"     In unselected cirrhotic patients with bleeding gastric varices to compare the influence on     mortality rate, duration of life, control of bleeding, quality of life, and economic costs of     treatment of: portacaval shunt, endoscopic variceal sclerotherapy and/or variceal ligation.   "
226774|NCT00820807|"     This study will critically evaluate the effects of a novel dietary fiber administered to     subjects at high risk for developing diabetes to determine if this intervention will improve     insulin sensitivity compared to control product administration and, thus, decrease risk for     developing diabetes.      The hypothesis is that consuming this novel fiber twice a day for 12 weeks will significantly     decrease fasting plasma glucose, insulin and glycosylated hemoglobin values in pre-diabetic     subjects (i.e. subjects with fasting plasma glucose levels 95-140 mg/dl at screening)     compared to consumption of the control product.   "
226775|NCT00820820|"     Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent,     and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a     temporary immunosuppression; furthermore, an improvement of AD has been observed during     measles infection.      This trial is aimed at demonstrating that measles vaccine is able to create an     immunomodulation and to improve AD symptoms.      30 adult patients of both sexes with moderate to severe AD will be randomly assigned to     measles vaccine (ROUVAX ®), or placebo (vehicle) and follow-up for 45 days.      The primary outcome is the effect of anti-measles vaccination on the T cell responses in     patients; Other outcomes include: clinical evolution of AD, as measured by the SCORAD, the     evolution of blood level of measles specific IgE and antibodies; evolution of other     biomarkers and phenotypic characteristics of T lymphocytes.   "
226776|NCT00820833|"     The purpose of this study is to determine whether infants, from overweight or obese mothers,     fed a formula with proteins and calories different than a standard infant formula have a     different growth   "
226777|NCT00820846|"     The purpose of this study is to evaluate the safety of and immune response to a two-vaccine     regimen in healthy, HIV-uninfected adults who have never received an HIV preventive vaccine     before.   "
226778|NCT00820859|"     The purpose of this study is to examine the efficacy of non-pharmacological ways to treat     agitated behaviors in nursing home residents with dementia. The hypothesis is that     non-pharmacological interventions will be more effective than placebo in decreasing such     behaviors.   "
226779|NCT00820872|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together     with carboplatin, trastuzumab, and lapatinib may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with     carboplatin, trastuzumab, and lapatinib in treating patients with early stage breast cancer.   "
226780|NCT00820885|"     The primary objective of the study was to study the safety and tolerability of teduglutide     following a once or possibly twice daily subcutaneous injection for eight consecutive days in     healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide     following a once or possibly twice daily injection for eight consecutive days in healthy     subjects.   "
226781|NCT00820898|"     This phase II trial is studying the side effects of gemcitabine and to see how well it works     in treating patients with recurrent or persistent endometrial cancer. Drugs used in     chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing.   "
226782|NCT00820911|"     This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free     (calcineurin inhibitor) regimen in renal transplant recipients.   "
226828|NCT00815009|"     Moderate exercise with a low fat and/or a moderate fat with low processed carbohydrate diet     will have a greater effect on slowing disease progression and reversing hepatic steatosis     and/or necro-inflammation in the liver of adult patients with NAFLD and NASH when compared to     a regular healthy diet alone.   "
227077|NCT00818272|"     This observational study is in line with the German educational plan with the aim to     implement a tool to increase and monitor the awareness for tuberculosis screening and to     reinforce the patient eligibility for a treatment with Remicade according to the Summary of     Product Characteristics (SmPc).   "
226783|NCT00820924|"     The underlying biology of the various patterns of metastasis observed in different tumour     types remains unclear. The detection and characterization of circulating tumour cells in     cancer patients has provided important new information about the progression of metastatic     events. This information has important implications for cancer prognosis and therapy.      This multicenter open-label study is designed as a two-stage three-outcome phase II trial.     The aim is to evaluate the efficacy and safety of daily dose of Lapatinib in advanced breast     cancer patients with HER-2 non-amplified primary tumours and HER-2 or EGFR positive     circulating tumour cells. Evaluation of HER-2 and EGFR status on circulating tumour cells     will be performed by the means of the CellSearch equipment (Immunicon, Huntingdon Valley, PA,     USA) and FISH method (PathVysion Kit -Abbott Laboratories).   "
226784|NCT00820937|"     The aim of this study is to improve the diagnostic of Lewy body dementia by combining the     scintigraphy (SPECT) usig a spécific transporter and magnetic resonance imaging (MRI).   "
226785|NCT00820950|"     The study is comprised of two parts. The first portion of this study will be a double-blind,     Sponsor-unblinded, vehicle-controlled study with application of INCB018424 or vehicle to     paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part     2 of the study is a double-blind, sponsor unblinded, comparison of INCB018424 with two FDA     approved products in patients with active but stable plaque psoriasis.   "
226786|NCT00820963|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy in higher doses over a shorter period of time may kill more tumor cells and have     fewer side effects. Drugs used in chemotherapy, such as temozolomide, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. It is not yet known whether standard radiation therapy, higher-dose radiation     therapy, or chemotherapy is more effective in treating older patients with glioblastoma     multiforme.      PURPOSE: This randomized phase III trial is studying standard radiation therapy to see how     well it works compared with higher-dose radiation therapy or chemotherapy in treating older     patients with glioblastoma multiforme.   "
226787|NCT00820976|"     Background The effects of granulocyte colony-stimulating factors (G-CSF) on recovery     following induction chemotherapy are widely accepted. However, their impact on response and     survival has not been clarified yet. Male gender has been claimed to be a susceptibility     factor for development of leukemia and shorten survival but effect of sex has not been     analyzed in clinical trials utilizing G-CSF.      Design and Methods Efficacy and safety of G-CSF as an adjunct to de novo AML remission     induction therapy was assessed in this prospective randomized Phase III multicenter trial.     Patients were randomized to receive induction therapy consisting of either cytosine     arabinoside 100mg/m2/d, days 1-10 and idarubicin 12 mg/m2/d, days 1-3 (control arm) or plus     G-CSF (Filgrastim, 5 µg/kg/d starting from day 8 until absolute neutrophil count (ANC) over     0.5x109/L for two consecutive days) for a median duration of 14 days (G-CSF arm).      After achievement of CR, all patients received first consolidation course of Ara-C 1     gr/sq.m/d (d1-5) and Ida 12 mg/sq.m/d (d1-3). If patients did not have an HLA identical donor     they were randomized to receive second course of consolidation either high dose Ara-C 3     gr/sq.m/d (d1, 3, 5) or G-CSF for collection of stem cells for the consecutive PBSCT.   "
226788|NCT00814476|"     Randomized, two arms, controlled, open study comprised of two consecutive segments. At the     first segment that will last during the first 4 months of the study, patients will be     randomized to the Care link treated group or non Care link treated group. At this segment of     the study the usage of the Care link system will be accompanied by the diabetic team, through     at least monthly contact via the Internet initiated by the diabetic team. At the second     segment of the study, during the following 4 months, both groups will use the Care link     System, home-use, without support initiated by the diabetic team.   "
226789|NCT00814489|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2     formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in     young adults. Subjects will be vaccinated 2 times in an observer-blind manner with an     interval of 2 months. The subjects receiving Engerix-B will receive in an open-manner a third     dose of the vaccine at Month 6. The protocol posting has been updated following a protocol     amendment.   "
226790|NCT00814502|"     The purpose of this research study is to compare the effectiveness of Zolpidem CR to that of     placebo in improving sleep efficiency in people with dementia admitted to the hospital     because of their symptoms. You can participate in this study if you have dementia of the     Alzheimer's type or vascular dementia. This study involves placebo; a placebo is a tablet     that looks exactly like Zolpidem CR, the study drug, but contains no active study drug. We     will use placebos to see if the study results are due to the study drug or due to other     reasons. Zolpidem CR is also called Ambien CR and is widely available by prescription.     Zolpidem CR is approved by the U.S. Food and Drug Administration (FDA) for the short-term     treatment of insomnia (trouble falling or staying asleep).   "
226791|NCT00814515|"     A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007     (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to     Severe Dry Eye Syndrome   "
226792|NCT00814528|"     The purpose of this study is to compare the treatment of skin growths called actinic     keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other     conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil     (5-FU).   "
226829|NCT00815022|"     Several factors influence the extension of anesthetic mixture during spinal anesthesia     including anesthetic gravity, body position, drug volume, and drug-delivering velocity.     However, the effect of temperature of anesthetic mixture on the cephalad sensory blockade is     hitherto unknown. The investigators hypothesized that different temperatures of the     anesthetic mixture had different velocity of extension after spinal anesthesia. In addition,     previous studies suggest that parturients have relative higher sensitivity to temperature.     Herein the investigators proposed that the temperature of anesthetic mixture had more     extensive effect on the cephalad sensory blockade with spinal anesthesia for cesarean     delivery.   "
226830|NCT00815035|"     Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is     to produce a new treatment that would benefit subjects who have peanut allergy by lowering     the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune     response in subjects who have peanut allergy (tolerance).   "
226793|NCT00814541|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as doxorubicin and dexamethasone,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) together     with bortezomib may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin     and dexamethasone works in treating patients with multiple myeloma that has relapsed or not     responded to treatment.      PATIENT POPULATION: Patients with relapsed or refractory multiple myeloma requiring therapy     will be invited to participate in this study. Eligible patients will be >18 years old and     able to give fully informed consent. Patients must have a Performance Score (PS) of 0-3     (ECOG), measurable serum and/or urine paraprotein, or serum free light chain, bilirubin value     of less than one and a half times the upper limit of normal with ALT/AST values less than two     and a half times the upper limit of normal. Patients with non-secretory multiple myeloma are     excluded from this study.   "
226794|NCT00814554|"     The aim of this study is to compare the effectiveness of three public health intervention     strategies to reduce weight excess and obesity prevalence among teenagers within the frame of     a public health program aiming at promoting healthy eating and physical activity behaviors.   "
226795|NCT00814567|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known     whether intensity-modulated radiation therapy is more effective than standard radiation     therapy in treating patients with early-stage breast cancer.      PURPOSE: This randomized phase III trial is comparing radiation therapy regimens in treating     women with early-stage breast cancer who have undergone breast-conservation surgery.   "
226796|NCT00814580|"     The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone     IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.   "
226797|NCT00814593|"     RATIONALE: Biological therapies, such as lymphokine-activated killer cells, may stimulate the     immune system in different ways and stop tumor cells from growing. Drugs used in     chemotherapy, such as Gliadel wafer, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. It is not yet known     whether lymphokine-activated killer cells are more effective than Gliadel wafer in treating     patients with glioblastoma multiforme.      PURPOSE: This randomized phase II trial is studying the side effects and how well     lymphokine-activated killer cells work compared with Gliadel wafer in treating patients with     newly diagnosed glioblastoma multiforme that can be removed by surgery.   "
226798|NCT00814606|"     This study seeks to evaluate the safety and efficacy of taking fluvastatin along with     peginterferon alfa in previous partial responders with genotype 1 HCV.   "
226799|NCT00814619|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus     thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses     over a shorter period of time, may kill more tumor cells and have fewer side effects.     Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. It is not yet known whether giving     capecitabine together with 3-D conformal radiation therapy is more effective with or without     panitumumab in treating patients with advanced rectal cancer.      PURPOSE: This randomized phase II trial is studying giving capecitabine together with     radiation therapy to see how well it works with or without panitumumab in treating patients     with advanced rectal cancer.   "
226800|NCT00814632|"     Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or     pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of     these factors may include altered immune response, infections, altered vaginal acid-base     balance, allergic reactions and psychosexual disorders. Women are generally treated with     medications such as anti-histamines, anti-depressants and anti-inflammatories, or with     physical therapy to minimize symptoms. Other therapies for vulvodynia include topical agents     (lidocaine, or compounded medications such as baclofen, gabapentin and amitriptyline), oral     medications (gabapentin, pregabalin, calcium citrate), complementary therapies (yoga, guided     imagery, cognitive behavioral therapy) or a low-oxalate diet, but these are often     ineffective. Surgery for vulvodynia may be helpful in the hard to manage cases, but is     utilized as a last resort.   "
226801|NCT00814645|"     This study is designed to investigate the safety and tolerability of AIR001 Inhalation     Solution when administered under conditions of hypoxia and to identify dose levels of drug     resulting in a reduction in pulmonary arterial pressure under these hypoxic conditions.   "
226802|NCT00814658|"     The purpose of this study is to evaluate the combination of galantamine with nimodipine in     patients with mixed dementia on cognition and quality of life.   "
226803|NCT00814671|"     The goal of this Phase 2 study is to determine the microbiological activity and safety of     rifapentine when given as a component of multidrug intensive phase treatment of     smear-positive pulmonary TB.      Funding Source- FDA OOPD   "
226831|NCT00815048|"     The investigators hypothesize that the use of a combination of Atropine and Remifentanil will     safely facilitate non emergent intubation procedure as effectively as the protocol of     Atropine, Fentanyl, and Succinylcholine.   "
226832|NCT00815061|"     The aim of the present study was to describe the incidence and prevalence of IBD in non     Jewish Israel population   "
226833|NCT00815074|"     The purpose of this study is to gain better understanding of how recently deployed military     women managed urinary and vaginal symptoms while deployed. Participants in this study will be     asked to take part in a 45-60 minute interview.   "
226834|NCT00820989|"     The body's immune response to injury or infection is very complex.Endotoxin is a man-made     substance, which causes the body to mimic sickness (fever,chills, and achiness)for a few     hours. This study is designed to determine whether certain proteins, genetics, or heart rate     variability change affects the body's response to endotoxin.   "
226835|NCT00821002|"     The study objective is to compare IOP and safety outcomes based on plug placement (upper or     lower puncta).   "
226804|NCT00814697|"     The investigators wish to investigate the efficacy of targeted repetitive transcranial     magnetic stimulation (rTMS) on expressive language in patients with Alzheimer's disease (AD).     In rTMS, magnetic pulses are used to noninvasively stimulate focal areas of cortex of about a     square centimeter in area. rTMS has been approved in the United States for the diagnosis of     peripheral nerve conditions.      Depending on the frequency of stimulation, rTMS can preferentially stimulate or inhibit     cortical areas. In stroke rehabilitation, for example, inhibition of the contralateral,     uninvolved hemisphere by low frequency rTMS has improved movement of the affected limbs     because of less aberrant inhibition of the affected hemisphere by the healthy hemisphere. The     effects of rTMS has also been investigated and found to be useful in treating refractory     depression and depression in Parkinson's disease. In addition, rTMS has improved naming in     patients with Alzheimer's disease and has improved cognitive abilities and memory in     non-demented older adults. Two studies found that rTMS improved aphasia in patients with     stroke. While these studies are small, a review of the literature suggests that there may be     a beneficial role for rTMS in patients with chronic neurological conditions. In addition,     rTMS appears to be well tolerated, with transient headaches being the most common side     effect.      In this small open label study, the investigators wish to investigate the usefulness of     bilateral stimulation of the brain region termed the dorsolateral prefrontal cortex (DLPFC)     in patients with AD who have naming and language deficits.   "
226805|NCT00814710|"     The purpose of this study is to assess the immunogenicity in terms of antibody response and     the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse     events following primary vaccination of Indian infants with pneumococcal conjugate vaccine     GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined     vaccine during the first 4 months of life. The study will be conducted in India.   "
244525|NCT01056120|"     To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent     system in a patient population within that defined in the Instructions for Use.   "
226806|NCT00814723|"     Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often     have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an     evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients     with primary hypercholesterolemia where the combination therapy with statins     (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should     be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total     cholesterol levels compared to monotherapy.   "
226807|NCT00814736|"     To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors     UK369,003 and sildenafil   "
226808|NCT00814749|"     To test the value of preoperatively performed urodynamics with regard to outcome of surgery     for stress urinary incontinence (SUI) and to examine whether not performing urodynamics     preoperatively is more cost effective than performing urodynamics preoperatively using the     non-inferiority assumption.   "
226809|NCT00814762|"     The purpose of this research study is to evaluate the safety of GSK Biologicals'     investigational HIV vaccine 732461, administered as two doses approximately 1 month apart, in     a small group of HIV infected people.   "
226810|NCT00814775|"     The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach     Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients     where this may be difficult.   "
226811|NCT00814788|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such     as bicalutamide, may lessen the amount of androgens made by the body. Everolimus may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.      PURPOSE: This phase II trial is studying bicalutamide and everolimus to see how well they     work compared with bicalutamide in treating patients with recurrent or metastatic prostate     cancer.   "
226812|NCT00814801|"     The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day     and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment     of patients with Alzheimer's disease.   "
226813|NCT00814814|"     Management of cardiac arrest is complicated by the lack of a readily available tool     identifying individuals who are likely to be successfully resuscitated. S100 beta is a     protein that originates in the astroglial cells of the brain, and NSE (Neuron Specific     Enolase) is another protein that originates in the neurons themselves. In the laboratory, the     concentration of these proteins correlate with evidence of brain damage after head trauma,     stroke and exposure to low levels of oxygen. The concentration of these proteins in the blood     of human survivors of cardiopulmonary resuscitation in humans is much higher than in patients     who were resuscitated but did not survive. However, it is still unclear whether survivors     from cardiopulmonary resuscitation have higher levels of these proteins in their blood if     they survive with neurological injury secondary to the arrest and resuscitation.      Hypothesis: In humans, the blood concentrations of protein S100 beta and NSE during and after     resuscitation can predict who will die despite cardiopulmonary resuscitation and who will     survive with neurological injury secondary to the arrest and resuscitation.   "
226814|NCT00814827|"     Opportunistic infections are caused by bacteria, mycobacteria, fungi or viruses that do not     normally cause infections in people with healthy immune systems. Some of these infections can     cause public health concerns, especially in areas with limited access to treatment. People     who acquire opportunistic infections usually have diseases that affect their immune systems,     such as human immunodeficiency virus (HIV), or do not have enough white blood cells to fight     the infection. However, some people acquire opportunistic infections even though they have     normal amounts of white blood cells and are free from known diseases that harm their immune     systems. This study will investigate some of the reasons that otherwise healthy people get     opportunistic infections to learn more about why some people are more likely to have them.      This study will include up to 210 HIV-negative males and females older than 18 years of age     who have opportunistic infections. The patients will be drawn from multiple sites in Thailand     and Taiwan including Khon Kaen University Hospital, Siriraj Hospital, Ramathibodi Hospital,     National Taiwan University Hospital, National Cheng-Kung University Hospital      Patients will undergo an initial evaluation that will include a physical examination, medical     history, and blood and urine testing. Additional tests will be conducted if the researchers     consider that the tests are medically necessary to treat the opportunistic infection; the     results of the tests will be reviewed and saved for study purposes. Depending on the severity     of the infection, the initial evaluation may take more than 1 day to complete.      After the evaluation, patients will be given standard and appropriate medicines to treat the     infections.      Patients will return for follow-up visits to allow researchers to monitor their condition and     to assess how well the patient is responding to the treatment. Patients will be evaluated by     the study researchers at least once a year for 2 years following the initial treatment.   "
226815|NCT00814840|"     The purpose of this study is to assess the efficiency of permanent biventricular pacing using     three ventricular leads in terms of reduction in adverse cardiac events rates, improvement in     cardiac capacity and patients' functional status in subjects with congestive heart failure     and a physiologic (sinus) rhythm.   "
226816|NCT00814853|"     Neurally adjusted ventilatory assist (NAVA) is a FDA approved mode of mechanical ventilation.     This mode of ventilation is currently in routine use in adult, pediatric and neonatal     intensive care units. The electrical activity of the diaphragm, the largest muscle used     during respiration, is measured. The ventilator applies support in proportion to the measured     electrical activity of the diaphragm (Edi). This electrical activity is measured through a     feeding tube that also has a multiple-array esophageal electrode in it.      Whenever a patient gets extubated in our MSICU, we conduct a routine extubation readiness     test. This is standard of care in our ICU. If the patient fails this test, the patient stays     on the ventilator. If he passes, he gets extubated. We wish to conduct a study during which     we will monitor the electrical activity of the diaphragm during this test. If the patient     passes the extubation readiness test, the study is complete. If he fails, he resumes on the     ventilator. In our study, we would then use the measured signal of the diaphragm to guide the     ventilator. This mode of ventilation is called NAVA. We do not currently use this mode of     ventilation in the ICU, but could do so since it is FDA approved. However, we wish to use     this protocol to gain more expertise with this mode of ventilation in the ICU in a controlled     fashion. We wish to enroll 20 pediatric patients. Patients in the ICU are routinely on a     variety of different models of ventilators. Usually, the respiratory therapist determines     which ventilator will be used. All patients in this study would be on the Servo-I ventilator,     which is an FDA approved ventilator and capable of monitoring electrical activity of the     diaphragm and currently used in our MSICU.   "
226817|NCT00814866|"     Osteoclastic bone resorption depends on both the capacity to generate osteoclasts     (osteoclastogenesis) and on individual osteoclast activity. The investigators objective is to     study the effect of anti-TNF therapy on the number of osteoclast precursors in the peripheral     blood of patients with Rheumatoid Arthritis, on in vitro osteoclastogenesis and on osteoclast     activity before and during the treatment of patients with Rheumatoid Arthritis with     Adalimumab.   "
226819|NCT00814892|"     RATIONALE: Vaccines made from tumor cells or dendritic cells may help the body build an     effective immune response to kill tumor cells. It is not yet known which vaccine is more     effective in treating patients with prostate cancer.      PURPOSE: This phase II trial is studying how well the combination of a proven effective     allogenic whole prostate carcinoma cell (APCC) vaccine co-administered with ex vivo generated     dendritic cells (DCs)(DC-APCC) extend the time to prostate cancer progression.   "
226820|NCT00814905|"     Chorioamnionitis occurs in 1% to 5% of term pregnancies and may complicate up to 25% of cases     of preterm labor. The traditional regimen used to treat intra-amniotic infection is     intravenous ampicillin 2g every 6 hours and intravenous gentamicin 1.5 mg/kg every 8 hrs     until delivery . In the past the recommendation has been that the antibiotics be continued     postpartum until 24-48 hours afebrile. More recent studies have looked at using a one time     dose of antibiotics after delivery vs treating until 24-48 hours afebrile. There have been no     studies comparing treatment of chorioamnionitis with antibiotics vs no treatment with     antibiotics postpartum. The aim of this study is to compare no treatment vs treatment with     one dose after a vaginal delivery and one dose of antibiotics vs a full course until 24 hours     afebrile after a cesarean delivery complicated by chorioamnionitis. The hypothesis is that     there will be no difference in outcome between the two groups in each arm. This is a     randomized study. Once the patient delivers she will be randomized to one of two groups in     each arm. First arm (vaginal delivery) A: no treatment, B: treatment with a one time dose of     ampicillin/gentamicin; Second arm (c/s) A: one dose of ampicillin/gentamicin/clindamycin, B:     treatment with ampicillin/gentamicin and clindamycin until 24 hours afebrile. The goal of the     study is to determine the optimal postpartum management of chorioamnionitis.   "
226821|NCT00814918|"     The goal of this study is to compare how efficient two different types of PDTs are when used     in combination with topical 5-ALA. The two types of PDT lights are Blu-U light and Candela     V-beam Pulse Dye Laser.   "
226822|NCT00814931|"     The purpose of this study is to assess the effects of CXB722 on neuroendocrine stress     response and subjective reports related to mood and stress during and after experimentally     induced stress among healthy young males.   "
226823|NCT00814944|"     The purpose of this study is to determine the safety and efficacy of an ocular sirolimus     (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE     Model.   "
226824|NCT00814957|"     The purpose of this study is to investigate the relationship between the plasma     concentrations of the study drug and the amount of the study drug bound to the D3 receptors     of the brain after dosing of a new compound GSK618334.   "
226825|NCT00814970|"     To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of     de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA)     and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease     (PAD).   "
226826|NCT00814983|"     The primary objectives will be to measure the safety and efficacy of allogeneic stem cell     transplantation using a peripheral blood stem cell graft that has been depleted of CD45RA+     Naive T-cells.      The secondary objectives will be to measure the pace of immune recovery.   "
226827|NCT00814996|"     There are two research purposes of this study. One is to explore which psychosocial issue or     biological issue would affect the social function among people with schizophrenia. The other     one is to explore which social function would affect the job tenure among people with     schizophrenia. There are 60 participants diagnosed with schizophrenia and divided into two     groups, employment and unemployment. we will use several social function tests to collect     social function, PANSS to evaluate their psychotic symptoms. And then we will compare and     analysis the data through statistic software. Finally, we will have he answer about how     social skills affect the social function and which social skill would affect the job tenure     among people with schizophrenia.   "
227587|NCT00831428|"     The Scottish National and District swimming teams will be screened for asthma and rhinitis     using both mannitol challenge and sport-based exercise challenge.   "
226836|NCT00821015|"     Atrial fibrillation is a common and disabling irregular heart rhythm, that affects 1 to 1.5     million Americans. Recent clinical experience with the Medtronic Arctic Front™ Cardiac     CryoAblation Catheter System suggests that it can be used to isolate the pulmonary veins     (PVs) safely and effectively in patients with AF, thereby reducing or eliminating the     recurrence of AF.3-4 However, the very large ablative surface of this balloon ablation     catheter raises the possibility that this technique may damage extensive areas of the atrial     myocardium.      The LA is an elastic chamber, designed to expand and contract with ease to accommodate the     influx and outflow of blood, while maintaining relatively low pressure. When exposed to     stress or injury, whether acute or chronic, the LA may lose much of its elasticity, resulting     in overall dilation accompanied by fibrosis in some cases. Overall, this may potentially     result in diminution of LA mechanical function (both systolic contractile function, and     diastolic relaxation function). In addition, LA function is linked to both Left Ventricular     (LV) systolic and diastolic function, manifesting in an overall impact on cardiac remodeling,     including the area of the pulmonary vein ostia, and a significant decrease in LV ejection     fraction (LVEF). On the other hand, the positive effects of maintaining sinus rhythm with     successful catheter ablation of AF may result in improvement of LA mechanical function.5-9      Based on the potentially deleterious effects of damage caused by cryoablation, to the atrial     myocardium during balloon ablation, this prospective, non-randomized, single-center study has     been designed to assess the atrial effects of balloon cryo-ablation.   "
226837|NCT00821028|"     To see if restenosis rates of superficial femoral artery atherosclerosis with percutaneous     techniques can be improved using paclitaxel.   "
226852|NCT00821236|"     The purpose of this study is to compare LASIK outcomes using the WaveLight ALLEGRETTO WAVE™     wavefront guided or optimized excimer laser treatment with the AMO/VISX CustomVue™ and the     LADARVision 4000 excimer laser treatment.      Standard refractive outcomes such as uncorrected and best corrected visual acuity, and     intended vs. achieved postoperative refractions will be evaluated; in addition, high order     optical aberrations, contrast sensitivity, and topography will be measured.   "
227058|NCT00818025|"     The purpose of this randomized controlled trial is to test the efficacy of a novel     intervention, Pocket PATH (Personal Assistant for Tracking Health) for promoting self-care     agency, self-care behaviors, and transplant-related health.   "
226838|NCT00821041|"     Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia,     such treatments are underutilized. This study evaluates the impact of a 6-week, online     treatment for insomnia.      Design This is a randomized controlled trial with online treatment and waiting list control     conditions.      Participants      Participants are adults in Manitoba Canada with chronic insomnia.      Setting      Participants receive online treatment from their homes. Intervention. Online treatment     consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep     restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help     with medication tapering. Measurement and Results. The impact of online treatment on primary     end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.   "
226839|NCT00821054|"     This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability     of lapatinib administered after a high or low-fat meal.   "
226840|NCT00821067|"     D-ribose, a natural occurring pentose carbohydrate, has repeatedly shown to enhance     high-energy phosphates and improve function following ischemia, states of congestive heart     failure, and recently in subjects with lung disease. An initial preliminary, open label pilot     study demonstrated a positive benefit of D-ribose in Baby-Boomer subjects aged 50 to 65     years old complaining of persistent fatigue. The objective of this study will build on the     previously collected data to evaluate oral D-ribose vs. dextrose (administered as a     supplement) in relatively healthy, yet fatigued subjects with a goal of improving their state     of fatigue.   "
226841|NCT00821080|"     This study is evaluating a combination of drugs called sirolimus and vandetanib to treat     glioblastoma. Sirolimus has been approved for use in patients who undergo organ transplants.     Sirolimus works by suppressing the immune system so the body will not reject the transplanted     organ. Vandetanib is an investigational drug and we are trying to find the highest and safest     dose of vandetanib with sirolimus that can be given safely.   "
226842|NCT00821093|"     This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.)     versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with     chronic obstructive pulmonary disease.   "
226843|NCT00821106|"     Transradial approach of cardiac catheterization is a common alternative to transfemoral     access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The     transradial approach reduces access site bleeding complications and the procedural discomfort     of the patients. Transradial procedures may be performed by cannulation of the right or left     radial artery and at present, the choice of the right or left radial artery depends largely     on the operator' s preference.      The aim of this study is to evaluate safety and efficacy of transradial approach comparing     the right radial versus the left radial approach in coronary diagnostic and interventional     procedures.      The investigators will enroll consecutively for 12 months all patients who undergo to     diagnostic or interventional procedures through trans radial approach in two Italian centers     (Casilino Policlinic, Catholic University-Rome).      Primary end point of the study is the fluoroscopy time and the radiation dose adsorbed by the     patients. Secondary end-points are: contrast amount, time to obtain the first angiography,     procedural shift rate, number of catheters employed, major complications.      The investigators pre-specified a sub-study in patients older than 75 years old with the same     end-points.   "
226844|NCT00821119|"     The purpose of this study is to evaluate the hypothesis that nasal intermittent positive     pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will     decrease the need for conventional endotracheal ventilation when compared to nasal continuous     positive airway pressure.(NCPAP)   "
226845|NCT00821132|"     We are collecting blood samples, clinical and family information from ALS (amyotrophic     lateral sclerosis) patients and their families to identify causes of ALS and ALS/dementia.   "
226846|NCT00821145|"     In many countries the gold standard for treating abdominal aortic aneurysms is still open     surgery with a long incision. In patients with suitable anatomy alternatively an endovascular     approach can be chosen. Since open surgery is more durable in many countries a laparoscopic     procedure using  key hole surgery  has gained wider acceptance. The current study wants to     prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with     reduced recovery times.   "
226847|NCT00821158|"     The investigators will examine whether administration of certain medications will decrease or     prevent ischemia-reperfusion injury.   "
226848|NCT00821184|"     This study will help determine if behavior modification performed in conjunction with oral     Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms     than oral Vesicare anticholinergic therapy alone.   "
226849|NCT00821197|"     The main study objective:      To evaluate long-limb gastric bypass (150 cm alimentary limb) vs. distal gastric bypass     (common channel 150 cm) in the treatment of superobesity (BMI 50-60 kg/m2).      The main study hypothesis:      Distal bypass accomplish an estimated 10-20 % larger weightloss than long-limb gastric bypass     1 year after surgery. Patients subject to distal bypass have more gastrointestinal side     effects and more extensive nutritional deficiences compared to long-limb gastric bypass.   "
226850|NCT00821210|"     Specific Aim        1. To determine the prevalence of OSA in patients of first-time AMI in acute phase By          screening patients of first-time, single-vessel disease, Killip I AMI, and successful          revascularization        2. To determine the impact of CPAP treatment on the prognosis of AMI Using sham CPAP as the          optimal placebo, we conduct this randomized, double-blind, placebo controlled trial to          assess the 12-week CPAP effect in moderate-severe OSA patients.        3. To determine how the OSA affects patients with MI in acute and chronic phase and vice          versa, which is dissected from mechanical basis and molecular basis By comparing the          clinical parameters of AMI patients without OSA (AHI<5/hr), mild OSA (5 < AHI <15),          moderate OSA (15<AHI<30) and severe OSA5 (AHI>30/hr), and before and after CPAP          treatment, we can determine the interaction between OSA and AMI.   "
226851|NCT00821223|"     Hypothesis :      Phacoemulsification is superior to SICS with regards to:        -  Immediate unaided high and low contrast visual performance        -  Its impact on quality of life.   "
226879|NCT00822640|"     A population of 100 patients randomised to rotating and fixed PE inlays in the Columbus knee     prosthesis received a navigated TKR. Knee Society Score as primary endpoint, Oxford Score,     and postoperative ROM after one year will be compared.   "
226853|NCT00821249|"     This is a 2-phase study during which patients with relapsed or refractory multiple myeloma     (MM) or plasma cell leukemia (PCL), who have already received at least two previous     treatments, will receive investigational study drug ARRY-520.      The study has 3 parts. In the first part of the study, Phase 1, patients will receive     increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF)     support, in order to achieve the highest dose possible that will not cause unacceptable side     effects. Approximately 30 patients from the US will be enrolled in Part 1 (Active, not     recruiting).      In the second part of the study, Phase 2, patients will receive the best dose of study drug     determined from the first part of the study and will be followed to evaluate what side     effects the study drug causes and what effectiveness it has, if any, in treating the cancer.     Approximately 30 patients from the US will be enrolled in Part 2 (Active, not recruiting).      In the third part of the study, Phase 2 with Dexamethasone, patients will receive the best     dose of the study drug determined from the first part of the study, in combination with     dexamethasone, and will be followed to evaluate what side effects the combination causes and     what effectiveness the combination has, if any, in treating the cancer. Approximately 50     patients from the US will be enrolled in Part 3 (Active, not recruiting).   "
226854|NCT00821262|"     Patients undergoing high risk cardiac surgery (combined CABG and valvular procedures) will be     randomized to receive a total intravenous anesthesia or an anesthesia plan with sevoflurane.      The investigators want to document whether the cardioprotective properties of volatile agents     could translate in an improved outcome after cardiac surgery in high risk patients.   "
226855|NCT00821275|"     The efficacy and safety of uterine artery embolization, as compared with standard surgical     methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of     this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief,     complication, fertility, ovarian function and quality of life with uterine artery     embolization for uterine fibroids comparing with standard surgical methods.   "
226856|NCT00821288|"     The overall goal of this proposal is to improve the post-treatment care of breast cancer     survivors and to understand the barriers to optimal post-treatment care in Latina and     Non-Hispanic women.   "
226857|NCT00821301|"     The purpose of this study is to evaluate the safety and tolerability of fluphenazine in     patients with advanced multiple myeloma. The study will also describe the efficacy of this     drug.   "
226858|NCT00821314|"     Importance of the problem OAB is a common health problem. Milsom et al. [1] randomly selected     a population from six European countries. From this population, 17% of the respondents     reported having OAB symptoms with 14% reporting frequency, 9% urgency, and 6% urge     incontinence. The study by Milsom et al. [1] showed that OAB adversely affected the lives of     the majority (65%) of the respondents who reported OAB symptoms. Chen et al. [2] also     reported that the prevalence of OAB in Taiwanese women was similar to that of Western women.     In the study of Chen et al.[2], the prevalence of OAB was 18.6% for the patients; perceptions     and the number of OAB condition significantly increased in the elderly women (over 65 years     old, 39.3%). Apart from impairing the physical health, OAB may have a tremendous effect on     psychological and social well-being. Information on the symptoms and disease severity can     yield important information that often complements objective measures.      Incontinence, increased urge and increased frequency of micturition affect nearly 100 million     people in the western world (33 million in the US and 66 million in the European Union).     These conditions are not life threatening but they seriously affect quality of life and     ability to work. OAB is in some studies reported to have an incidence of up to 17 % in the     western population with great consequences for the quality of life.      Economic cost The total economic cost of this group of conditions is high. In 2002 the costs     in the US were approximately $12.7 billion[1] (estimated to be $17 billion and €22     billion/year in 2005). Approximately 25% of this expenditure is spent on treatment (drug     therapy, clinical consultation and surgery). Of those who suffer only 28% have sought help     and only half of those currently receive treatment. Less than 3% regain long lasting normal     control. Therefore, these costs are an under-estimate and the problem is large.      Aetiology   "
226859|NCT00821327|"     The primary objective of this nonrandomized Phase II study is to evaluate the objective     response rate (ORR, CR+PR) in patients with advanced/metastatic UC treated with the     combination of gemcitabine, cisplatin, and sunitinib.   "
226860|NCT00822393|"     This randomized allogeneic transplantation protocol compares i.v. Treosulfan-based     conditioning therapy with reduced intensity i.v. Busulfan-based conditioning in adult AML and     MDS patients at increased risk for standard conditioning therapies. The protocol is based on     results of previous phase I/II trials evaluating Treosulfan/Fludarabine conditioning prior to     allogeneic haematopoietic stem cell transplantation. The reference arm (reduced intensity     i.v. Busulfan/Fludarabine) is considered to be accepted medical practice for the study     patient population.   "
239275|NCT00986739|"     The aim of this multicenter study is to investigate risk factors for unplanned     hospitalizations, including individual and environmental factors, notably air pollution.   "
226861|NCT00822406|"     A total of 41 adults with perennial allergic rhinitis were enrolled in a first double-blind     placebo-controlled phase for six months, and treated on a weekly basis with sublingual doses     of single individualized homeopathic medicines or placebo. After this closed initial phase,     all patients were invited to participate in an long-term open-label controlled phase, in that     they would receive homeopathic treatment for the maximum period of 36 months, and the results     were compared with the improvement of initial phase. Signs and symptoms scores, rescue     medication requirements and quality of life were assessed by questionnaires and personal     clinical evaluation by a same independent researcher, before and after each phase. Primary     and secondary clinical outcome were, respectively, specific and general allergic signs and     symptoms scores. Total IgE titles were performed before and after each phase.   "
226862|NCT00822419|"     Since midsternotomy is painful postoepratively, and since ketamine has been shown to be     optimal postoeprative analgessic adjuvant, the investigators wish to assess its percutaneous     preemptive effect, comparing it to lidocaine effect.   "
226863|NCT00822432|"     High dose methotrexate (MTX) is responsible of severe toxicity in patients in whom     elimination from plasma is delayed. Factors responsible for MTX accumulation are partly known     but some patients still experience toxicity despite adequate measures being taken. Our     hypothesis is that renal tubular secretion may be impaired in these patients. This study aims     at evaluating the performance of the UCP ratio (urinary ratio of coproporphyrins), a putative     biomarker of tubular secretion, in predicting delayed MTX elimination.   "
226896|NCT00822861|"     During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic     anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum     eosinophils and the airway responses during an allergen challenge at different dose levels.   "
226864|NCT00822445|"     Traumatic brain injury (TBI) is a Public Health problem, because of the numbers of events     (more than 200,000 per year in France). Craniocerebral tomodensitometry (CCT) is widely used     for the diagnosis of minor/mild TBI, but both the access to the CCT and the cost of this     imagery are critical factors. We hypothesized that the blood level measurement of S100     protein (S100), a neurological biomarker of cerebral injury, would help to the clinical     evaluation of minor/mild head injury events, and would be an economic alternative to CCT for     the diagnosis of these pathologies. In addition, a part of the study will explore the     prognostic value of such blood level S100 determination for the evaluation of medical/social     consequences of minor/mild TBI.      Medical objective of the study:        1. to assess the contribution of early determination (to medical care) of S100 for the          diagnosis of minor/moderate TBI (TCCMM - Glasgow sup or equal to 9),        2. to determine the usefulness of a second dosage three hours later for the medical          decision.      In other words, to compare S100 biomarker and CCT considered as a reference ( Gold     Standard) for the diagnosis or exclusion of TCCMM, and to precise its terms of use.      Economic objective:      to conduct a cost-effectiveness study of blood level determination of S100 vs. CCT for the     diagnosis of minor/moderate TBI and its medical/social consequences   "
226865|NCT00822458|"     This phase I trial is studying the side effects and best dose of GDC-0449 in treating young     patients with medulloblastoma that is recurrent or did not respond to previous treatment.     GDC-0449 may be effective in treating young patients with medulloblastoma.   "
226866|NCT00822471|"     A concise diabetes self-management education (DSME) program on the ABCs of Diabetes will be     placed in an urban public library to assess the feasibility of using this community setting     for the delivery of health care education in an urban African American population. Impact on     knowledge of, prescriptions for, and control of blood sugar (A1C), blood pressure (BP) and     LDL cholesterol (LDL-C)before and after participation in the program will be assessed. We     will also examine the frequency of emergency department (ED) visits and hospitalizations for     uncontrolled diabetes at 6 months post-DSME intervention.   "
226867|NCT00822484|"     The purpose of this study is to evaluate the safety and tolerability of single doses of     ILV-095 in healthy Japanese male subjects.   "
226868|NCT00822497|"     The purpose of this prospective, crossover randomized study is to explore the efficacy of two     music therapy protocols on pain, anxiety, and muscle tension levels throughout the     debridement process in individuals hospitalized with moderate to severe burns.   "
226869|NCT00822510|"     The purpose of this project is to test a telephone delivered educational support program     versus an education only program for improving symptom management and quality of life in men     with prostate cancer and their partners.   "
226870|NCT00822523|"     The purpose of this feasibility study is to determine if temporary weakness of a small foot     muscle caused by local injection of botulinum toxin into that muscle can be measured with a     strain gauge in addition to the previously known valid measurements via nerve conduction     studies and surface electromyogram.   "
226871|NCT00822536|"     To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin     and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting     stent (DES) implantation.   "
226872|NCT00822549|"     The main objective of this study is to improve our knowledge on the pharmacodynamic,     pharmacokinetic, and pharmacogenetic relationships of morphine administered to relief severe     postoperative pain. The analysis will encompass the efficacy (acute during titration and     subacute during the first 24 hours) and adverse effects of morphine. Our purpose is also to     better characterize the age- and sex-related differences which probably markedly differ     between the two periods (acute vs sub acute).   "
226873|NCT00822562|"     In this study, we intend to divide the subjects who have been confirmed recurrent HCC into     two groups: Group A: treatment with pure surgery or Group B: treatment with pure radio     frequency. We will compare the non-tumor survival time, long-term survival rate between the     two groups, summarize the merits and demerits of both groups, and try to establish a     standardized therapy and treatment for the this kind of patients through prospective studies     on the molecular biological difference of pathological samples between the first and second     surgeries.   "
226874|NCT00822575|"     The purpose of this study is to determine whether over-the-counter (OTC) use of the     ZapperClick device employing the piezo-electricity principle is effective in reducing itching     associated with mosquito bites.   "
226875|NCT00822588|"     The study is a prospective, controlled, randomised and assessor blind study that investigate     if the need for bank blood transfusion could be reduced in patients, undergoing primary or     revision total hip replacement surgery, who receive their own blood back with the medical     device Sangvia.      A comparison in need for bank blood will be made between patients that either receive their     own blood back or not.   "
226876|NCT00822601|"     Our study's purpose is to show the efficacy of the transcranial magnetic stimulation (a non     invasive method of cerebral modulation) in patients suffering from chronic obsessive     compulsive disorder (OCD). This new method will be applied in 20 patients during 4 weeks (5     sessions each week), and its effects on OCD symptoms will be compared to those of a sham     (=placebo) stimulation applied with the same process in 20 other patients, randomly assigned     to the comparison group. The maintenance of the therapeutic effects will be explored during 8     weeks following the end of the treatment. In addition to classical scales used to measure the     treatment effects, all patients will be examined using a functional magnetic resonance     imaging (fMRI) before and after treatment to explore the cerebral effects of rTMS   "
226877|NCT00822614|"     A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group Trial to Evaluate hte     Safety of Fentanyl TAIFUN Treatment after titrated Dose Administration and the Current     Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients on Maintenance Opioid     Therapy   "
226878|NCT00822627|"     Randomized controlled trial of influenza vaccination versus referral for vaccination in the     Emergency department. Is the Emergency Department an effective venue for vaccination for     influenza? Does vaccination for influenza in the Emergency Department change the rates of     influenza, influenza-like-illness or medical provider visits when compared with patient     referred for vaccination in the community?   "
244541|NCT01056328|"     The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation     System for the treatment of symptomatic paroxysmal atrial fibrillation.   "
226880|NCT00822653|"     For the end stage renal disease (ESRD) patients undergoing hemodialysis treatment,     specifically, reflex mediated calf muscle pump stimulation has the potential to significantly     reduce the number and magnitude of hypotensive episodes thus enhancing the effectiveness of     the dialysis process. Fewer hemodialysis complications during the patient's hemodialysis     treatment, would allow treatment sessions to continue to the prescribed volume removal, with     much reduced patient recovery time, and the costs associated with this recovery.   "
226881|NCT00822666|"     To evaluate the role of the genetic variant 2C19*2 on the pharmacodynamic response as     assessed by optical aggregometry and on the pharmacokinetic response as assessed by measuring     active metabolites following an oral administration of a loading dose of 300/900mg of     clopidogrel in patients with established coronary artery disease.   "
226882|NCT00822679|"     The purpose of the study is to examine the effects of Eszopiclone, a sleep aid, on     inflammatory mediators and coagulability in patients with a recent myocardial infarction.   "
226883|NCT00822692|"     Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke     Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated     skin abscess.   "
226884|NCT00822705|"     Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects   "
226885|NCT00822718|"     According to Seoul cancer registry data (2000), cancer became the leading cause of death in     Korea, accounting for 23.9% of all deaths and gastric cancer is the most prevalent malignant     neoplasm, comprising 20.8% of all cancers. Korea and some part of Asian countries have the     highest incidence of gastric cancer in the world. Therefore, gastrectomy became one of the     most common cancer operation in Korea. Thanks to early detection and intervention, the     mortality of early gastric cancer drops dramatically and is now believed to be one of the     most curable diseases among all the cancers. However, after successful operation and the     declaration of cure of the stomach cancer, the patients are left without stomach for all his     remaining life. If the patients lose most of his stomach tissue, there are several problems,     which include loss of reservoir function for food and indigestion. Besides, loss of appetite     is of the paramount importance because the stomach is an important endocrine organ     controlling the appetite via gut-brain axis and the main axis is through a hormone called     ghrelin, the only orexigenic hormone in human.      Because ghrelin is mainly secreted by the fundus and body, operations such as laryngoscopic     Roux-en-Y gastric bypass: (LRYGBP), laryngoscopic-adjustable silicone gastric banding (LASGB)     virtually abolish the ghrelin expressing cells. Thus loss of appetite is an inevitable     consequence. Then what happens of the plasma ghrelin after Billoth surgery (standard gastric     cancer operation) which removes antrum and body of the stomach where ghrelin expressing cells     are relatively less distributed? Also puzzling is the fact that after surgery some patients     start to gain weight while others continue to lose weight and appetite. Are there     ghrelin-expressing cell hyperplasia in the patients who start to gain weight?      The gastrectomy operation which is performed at the investigators institute is Billoth I or     II operation. The operation virtually eliminate the half of the body and most of the antrum.     If fundus is involved also, proximal gastrectomy is the operation of the choice. Most of the     patients who have these operations will lose weight during 1-3 months after surgery,     thereafter slowly recover. However, the mechanism of the weight recovery has not been     elucidated so far.      To elucidate the mechanism of re-gaining body weight and possible ghrelin expressing cell     hyperplasia, the investigators designed the prospective study to investigate the stomach     tissue as well as plasma ghrelin in the patients who are going to have Billoth surgery. The     items to be investigated include plasma for hormones (ghrelin, leptin, insulin, CCK, PYY),     stomach tissue for ghrelin, diet evaluation and body weight (body mass index) changes for 7     months after gastrectomy.      The investigators hope that their study will reveal the valuable information on the body     weight recovery and appetite issue. So far the issue of the stomach cancer patients was     related to survival issue. However, to lead a comfortable life the quality of life is also     very important. The investigators approach will hint the way of surgery which will benefit     the patients to live a happy life.   "
226886|NCT00822731|"     The purpose of this study is to establish a model which can predict the treatment outcome and     the risk of treatment-related morbidity in patients with lymphoma.   "
226887|NCT00822744|"     The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298     (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive     Disorder (MDD), based on the 17-item Hamilton Depression Rating Scale.      Secondary objectives are:        -  To evaluate the tolerability and safety of an 8-week treatment with SSR411298 versus          placebo in elderly patients with MDD.        -  To evaluate the effect of SSR411298 on disability, anxiety, cognitive function, sleep,          pain and somatic symptoms related to depression, and bone markers.        -  To assess SSR411298 plasma concentrations.        -  To assess plasma endocannabinoid concentrations.   "
226888|NCT00822757|"     This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of     Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to     provide necessary safety and immunogenicity data for the lyophilized formulation of V710     prior to its subsequent evaluation in patients at risk for developing serious S. aureus     infections.   "
226889|NCT00822770|"     The goal of this clinical research study is to learn about the safety of AMD3100 (plerixafor)     and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an allogeneic blood     stem cell transplant. This treatment will be studied in patients with acute myeloblastic     leukemia (AML), myelodysplastic syndromes (MDS), or Chronic myelogenous leukemia (CML).   "
226890|NCT00822783|"     Elevated levels of immunoglobuline E in blood are said to promote the occurence of atopic     dermatitis; in fact, many patients with atopic dermatitis have high IgE levels. This study     tried to explore whether the depletion of IgE from blood and skin might result in a change of     immunological parameters and might alter the clinical course of the disease.   "
226892|NCT00822809|"     This is a randomized phase IIIb study investigating the treatment of malignant ascites due to     epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. In order to make     the catumaxomab treatment more convenient for the patient and the hospital praxis the     tolerability of 3 hour infusions of catumaxomab with and without premedication of     prednisolone is evaluated.      A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to     two treatment groups in a 1:1 ratio.   "
226893|NCT00822822|"     The purpose of this research study is to find out what Moffitt and Lifetime patients think of     the electronic medical records process.   "
226894|NCT00822835|"     The purpose of this study is to evaluate the safety and tolerability of single doses of     ILV-095 in healthy subjects.   "
226895|NCT00822848|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as epirubicin and ifosfamide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed. Giving these treatments after surgery may kill any tumor cells that remain after     surgery.      PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when     given together with epirubicin, ifosfamide, and radiation therapy followed by surgery in     treating patients with high-risk stage II or stage III soft tissue sarcoma.   "
226898|NCT00822887|"     The purpose of the study is to find out the highest dose of vandetanib that can be safely     given with repeat radiation therapy.      This study drug has been designed to block certain chemical pathways that stimulate tumor to     grow. The study drug has been shown to slow the growth of a number of types of cancers.      This will be a dose escalation study. A dose escalation study means that successive groups of     patients will receive higher doses of the study drug. There are three dose levels. The dose     of the study drug received will depend on the stage the study has reached at the time a     patient decides to participate.      In addition to taking the study drug patients will also receive radiation therapy to the     brain tumor for 3 days.      Hypothesis The objective of this study is to determine the maximally tolerated dose (MTD) of     VANDETANIB given with 36 Gy hypofractionated stereotactic radiotherapy. The MTD will be dose     of VANDETANIB at which no patients develop acute grade 5 toxicity and less than 30% of     patients develop acute (within 30 days of radiation therapy) or delayed (at least 30 days     after radiation completed) dose limiting toxicities.   "
226899|NCT00822900|"     The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of     injury and given for a total of 96 hours), is more effective than placebo for treating     victims of moderate to severe acute traumatic brain injury.   "
226900|NCT00822913|"     The researchers investigated the effectiveness and safety of BoNT/A injected into the     detrusor muscle in patients with PD and MSA all of whom had detrusor muscle overactivity     unresponsive to conventional medical therapy.   "
226901|NCT00822926|"     Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has     also been reported to be helpful for some pain conditions. The investigators have observed     prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin     Type A (BTA) in patients with certain types of neuropathic pain. the investigators propose to     study if addition of BTA extends pain relief compared to placebo when injected subcutaneously     into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is     perceived as painful).   "
226902|NCT00822952|"     The purpose of this study is to evaluate an imaging capability Prostate Mechanical Imager     (PMI), a PC-based device utilizing a transrectal probe with pressure sensor arrays and motion     tracking system, aimed at providing composite elasticity images of the prostate.   "
226903|NCT00822965|"     The specific aims of the patient intervention are to:        1. increase patient knowledge about pacemakers (PM) and implantable          cardioverter-defibrillators (ICDs)        2. help patients to identify if their PM or ICD has been interrogated        3. improve patient's physician-patient communication skills        4. teach patients how to identify if their device has been recalled        5. train patients what to do in case of a device recall      The educational interventions proposed, if proven to be effective by this pilot, will provide     a low-cost, reproducible intervention to improve the clinical care and safe management of     pacemakers (PM) and implantable cardioverter-defibrillators (ICD) in patients. The goal of     the intervention will be to promote the safe use of implantable pulse generators.   "
226904|NCT00822978|"     This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people.     Groups of people will receive either the study medication (ACHN-490) or a placebo (normal     saline) as a single infusion. If the single dose is well tolerated then this group will     receive 1 dose per day for up to 10 consecutive days. A new group of people will receive the     study medication at a higher dose than the previous dose level as long as the previous dose     was safe.   "
226905|NCT00822991|"     The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using     Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound     (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk     patients for hepatocarcinogenesis,Furthermore, to analyze whether early detection of HCC by     CE-US has a survival benefit than that by B-mode US.   "
227073|NCT00818220|"     The purpose of this study is to determine whether the intervention of delaying cord clamping     for 30 to 45 seconds followed by one milking of the cord while simultaneously lowering the     VLBW infants below the introitus will result in less bleeding in the brain and fewer     infections while in the Neonatal Intensive Care Unit (NICU) and better motor skills at 7     months corrected age. The investigators will attempt to identify the mechanisms of effect     through measurement of biologic markers.   "
226906|NCT00823004|"     Failure to respond to controlled ovarian hyperstimulation (COH) is still a major concern in     assisted reproduction and there is no consensus on the ovarian stimulation choice regime for     poor responders.      Aim: To evaluate and compare the efficacy of a microdose GnRH agonist flare (MF) and a GnRH     antagonist/letrozole (A/L) protocols in poor responders undergoing in vitro fertilization     (IVF).      Methods: One hundred eighty poor responder patients will be randomized to an ovarian     stimulation protocol with either a MF or a letrozole and high dose FSH/hMG and flexible GnRH     antagonist protocol.   "
226907|NCT00823017|"     The purpose of this study is to investigate the effects of patient-preferred music,     relaxation music, and standard care environment on patients in intensive care units.   "
226908|NCT00823030|"     The purpose of this study is to determine the amount of improvement in bladder function and     pain relief with the administration of 2% alkalinized lidocaine in patients with interstitial     cystitis. Specifically, we want to see if the administration of 2% alkalinized lidocaine     treatments in the bladder improves urodynamic test result values. We hope to enroll     approximately 40 patients in this study.      Previous research has shown that the administration of 2% alkalinized lidocaine in the     bladder may improve the bladder's capacity to hold urine and urine flow rates while     simultaneously providing pain relief. As part of standard of care at the Smith Institute of     Urology Pelvic Pain Center, we routinely offer our IC patients 2% alkalinized lidocaine with     follow up urodynamic evaluation. Our research looks to expand upon the prior studies and     confirm the findings of improved bladder function and enhanced pain control of 2% alkalinized     lidocaine versus placebo by performing a second urodynamic evaluation, which is not routinely     performed.   "
226909|NCT00823043|"     The objective of the study was to evaluate whether timolol hemihydrate is more comfortable     upon instillation than timolol maleate in sorbate. This was an observational study. Subjects     with open-angle glaucoma or ocular hypertension were asked to complete a survey regarding     their normal treatment. No treatment was prescribed.   "
226912|NCT00823082|"     The purpose of this trial is to study the effects of preoperative antithrombin     supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order     to maintain antithrombin levels in a range greater than 58% of functional activity and,     eventually, to decrease negative clinical outcomes during the ICU stay.   "
226913|NCT00823095|"     To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the     reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by     measurements of wound size and wound culture.   "
226914|NCT00823108|"     The purpose of this study is to determine if a glucose-insulin-potassium (GIK) solution can     be safely administered to patients with septic shock. GIK has been used in thousands of     critically ill patients in research studies with very few safety concerns. However, there is     a lack of data in regards to patients with septic shock. There are many reasons to believe     that GIK would be beneficial in sepsis, including improving heart function and decreasing     inflammation. This study will administer intravenous GIK for 12 hours continuously and     monitor 10 subjects for 24 hours. A control arm will be used and 10 patients will receive the     same monitoring but will not receive GIK.   "
226915|NCT00823121|"     Cryopreservation of all embryos and transferring them subsequently in assisted reproductive     technology (ART) cycles to improve outcome.   "
226916|NCT00823134|"     The purpose of this study is to investigate the following topics:        -  Determine the accuracy of ApneaLink Plus in separating Apneas into Obstructive Apneas,          Mixed Apneas and Central Apneas.        -  Determine the accuracy of ApneaLink Plus in scoring Hypopneas according to the 2008          guidelines of the AASM = American Academy of Sleep Medcine.        -  Determine whether patients can start and stop the recorder and are able to attach the          additional effort sensor by themselves using the patient instruction sheet   "
226917|NCT00823147|"     Research shows that the immune system is involved in chronic pain. The immune system is     involved in the process of inflammation. The investigators are still learning about the     factors that cause inflammation, but know it can be measured in the blood. The purpose of     this study is to understand how negative thoughts affect the immune system in women with     chronic pain.      A sub-study asks subjects to store a blood sample for future research by the PI aimed at     identifying genetic markers in women with chronic pain.   "
226918|NCT00823160|"     Penetrating wounds to the heart may present to the emergency unit with the presence of blood     in the pericardial sac as determined on ultrasound. If these patients are stable, the study     hypothesis is that they can be managed with a very simple surgical procedure called a     subxyphoid pericardial window (SXW), in which the blood is drained from around the heart via     a small skin incision below the rib cage. In all other centres in the world these cases are     managed by open chest surgery called a sternotomy. The investigator's experience in dealing     with these injuries is that this is unnecessary and requires a large amount of resources for     no benefit to the patient.      In this study, patients are randomized to receive either open chest surgery (sternotomy) or     the much smaller operation of the SXW. The patients are then followed up with respect to     their hospital stay and any complications that they develop. Normally, a patient undergoing     open chest surgery will stay in intensive care unit for a minimum of 2 days and have a total     hospital stay of at least 7 days and be at risk of a number of complications such as     pneumonia. Patients undergoing a SXW usually remain in hospital for a period of 3 days and do     not require intensive care management.      The investigator's hypothesis is that in all these patients the heart injury has sealed and     the patient is no longer in any danger. It is not necessary to perform open chest surgery on     these patients.   "
226919|NCT00823173|"     The purpose of this study is to determine whether ESBA105, a topically applied TNF-alpha     inhibitor, is safe and clinically active when applied to the eye of patients suffering from     acute anterior uveitis   "
226920|NCT00823186|"     This phase I study is designed to establish an optimal dose of paclitaxel, under a fixed     cisplatin dose at 40 mg/m2, delivered every week for three weeks, as neoadjuvant therapy     before radical hysterectomy in bulky (FIGO IB2 or FIGO IIA with primary tumor dimension > 4     cm) squamous cell cervical cancer. This study will be conducted at all branches of Chang Gung     Memorial Hospital.      The starting dose of paclitaxel is 50 mg/m2, and will be escalated by increments of 10 mg/m2     to a maximum dose of 80 mg/m2. The drugs will be administered sequentially (paclitaxel first,     followed by cisplatin) within one day every week for three cycles.      A cohort of 3 patients, who are assessable for toxicity, is treated at each dose level. Each     patient receives a fixed dose of paclitaxel and cisplatin, without modification. If none of     the first 3 patients experiences a dose limiting toxicity (DLT, see definition below this     paragraph), then escalation to the next dose level will proceed. If one patient develops a     DLT, the cohort will be expanded to 6 patients. If no more than 1 of these 6 patients     experiences a DLT, then escalation to the next dose level will proceed. The maximum tolerated     dose (MTD) is the highest dose level at which no more than 1 of 6 patients experience a DLT.     This dose level will be considered as the recommended dose for Phase II study. Although     efficacy evaluation is not the main purpose of this study, a response rate of 60%, evaluated     immediately before or at surgery, in all cases who have undergone 2 cycles of therapy is     preset as a requirement for further phase II study using this regimen.The primary goal of NAC     in cervical cancer is to improve the feasibility of surgical treatment, radical hysterectomy,     without delaying the scheduled surgery or increasing the surgical risk or morbidity.     Therefore, the definition of DLT for NAC is responded to this principle, in addition to the     standard dose-limiting toxicity for phase I study.   "
226921|NCT00823199|"     This is a four week open label trial of ALLOPURINOL to the treatment regime of ten (10)     poorly responsive patients with schizophrenia, monitoring their response and side-effects. No     change in medication is required.   "
226922|NCT00823212|"     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™     Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo     atherosclerotic coronary artery lesions.      This clinical trial compares outcomes in patients treated with PROMUS Element to those in     patients treated with a different everolimus-eluting coronary stent. The lesions are of     average length in average-sized vessels (workhorse). A companion sub-trial evaluates     outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions     (LL).   "
226923|NCT00823225|"     The purpose of this study is to determine whether the additional therapy with low dose     urokinase is more effective than only a conventional standard therapy concerning     ulcer-healing, rate of major amputation and survival.   "
226924|NCT00823238|"     This is a prospective, randomized clinical trial comparing the effects of these 2 modes of     antibiotic treatment on BALF inflammation in young, P. aeruginosa-positive CF patients.   "
226925|NCT00823251|"     The purpose of this study is to assess the initial safety and technical feasibility of the     IlluminOss System in the treatment of fractures of bones in the hand.   "
226926|NCT00823264|"     Phenytoin is a medicine used to treat seizures. If too much is taken, patients have ill     effects including sleepiness, unsteady gait, and eye problems. The amount of drug in their     system can be measured in their blood. Charcoal is a medicine that can absorb phenytoin. We     want to see if giving multiple doses of charcoal will quicken the removal of phenytoin from     the blood. This is theorized to occur as charcoal absorbs phenytoin from across the     intestines and then is secreted in the stool. Patients will be selected to receive either     charcoal in multiple doses or no charcoal and their serum levels will be drawn repeatedly to     follow their level. The different groups will then be compared to see if multidose charcoal     does indeed increase the elimination of phenytoin from the body.   "
226927|NCT00823277|"     Definition:      the overall objective is to examine childhood obesity with focus on NAFLD and its treatment.     Further, we aimed to investigate the impact of genetic variation on obesity.      The specific aims are to;        -  describe the degree of NAFLD among overweight and obese, Danish children. (hypothesis;          the degree for pediatric NAFLD among Danish Children was equal that found in other          Caucasian paediatric study populations).        -  investigate the effect of a multidisciplinary intervention treatment of 1 year on liver          fat content.      (hypothesis; the intervention could reduce the liver fat percentage and a reduction in BMI     SDS would associate with a reduction in liver fat content) - Analyze changes in liver fat     content in relation to changes in levels of fasting blood variables to see if any of them     could be used as a clinical tool for monitoring hepatic steatosis in the clinic.      (hypothesis; serum aminotransferases (separately and their ratio, respectively), serum     insulin, and HOMA-IR could predict improvement in liver fat content      - Investigate the association between genetic variants and obesity.   "
226928|NCT00823290|"     Histone deacetylase inhibitors (HDACi) like LBH589 have recently been established as novel     potent anti-cancer agents for solid and hematologic malignancies. Several pre-clinical     reports have shown a good anti-tumoral activity of different HDACi on human or murine HCC     models. These compounds, e.g. Trichostatin A, SAHA, MS-275 and others, have been shown to     induce apoptosis in HCC cells and to inhibit growth of HCC by inhibiting proliferation and     tumor-related angiogenesis in vivo. Furthermore, HDACi sensitize HCC in a synergistic manner     to other forms of cytotoxic stimulation, e.g. by conventional chemotherapeutic drugs or     TRAIL-mediated apoptosis. It has also been shown that the combination of HDACi with various     kinase inhibitors like sorafenib, erlotinib or others, promotes the anti-tumor efficacy of     single agents.      Based on the investigators' own previous experiences with different HDACi and LBH589 in     preclinical HCC models, a strong anti-proliferative and pro-apoptotic as well as an     anti-angiogenic effect will be expected by combining LBH589 with an existing sorafenib     treatment. It is assumed that this combination will prolong overall survival and     time-to-progression with lowered adverse effects in HCC patients.   "
226929|NCT00823303|"     Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to     bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may     have different effects on blood calcium. This study will randomize patients with SHPT and     stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the     incidence of high blood calcium, and effectiveness of SHPT treatment.   "
226930|NCT00823316|"     The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human     umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg     in subject for the promotion of an engraftment and prevention of graft rejection and     Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for     children with acute leukemia.   "
227074|NCT00818233|"     The aim of the protocol is to document intra-observer and inter-observer variability with     dynamic contour tonometry, and will also test the theory that pulse amplitude, as measured by     dynamic contour tonometry, is correlated with the difference in systolic and diastolic blood     pressures.   "
226931|NCT00823329|"     The investigators are developing two new medical instruments: 1. the Intelligent Sensor Belt     (ISB), and 2. the Body Composition and Hydration Status Analyzer (BC-HS-A). ISB serves the     purpose of measuring calorie/ energy consumption of the human body during physical activity.     The BC-HS-A measures the body composition, i.e. the fat and lean body mass and the hydration     status i.e the amount of water inside and outside of the body cells.      The goal of this pilot study is to obtain data from the investigators prototype medical     instruments: 1. ISB, and 2. BC-HS-A during physical exercise and compare those results with     readings of other commercially available instruments or exercise equipments. The     investigators would be testing for technical feasibility and, through comparison with     existing measuring devices, the reliability of the investigators prototype.   "
226932|NCT00823342|"     For chronic HBV infection, an optimal pharmacological agent to promote recovery from chronic     HBV infection would be one that inhibits HBV DNA polymerase, combined with the clearence from     the liver of cccDNA to block HBV reactivation after the circulating viral burden has been     eliminated by therapy. The activity of clevudine on cccDNA in combination with its potent     antiviral activity on HBV polymerase makes it the optimal agent in combination with tenofovir     for this protocol.   "
226933|NCT00823355|"     Primary objectives are to evaluate the safety profile and tolerability of oral BCX1777 in     each cohort of patients with recurrent or refractory T/NK-cell malignancies and to evaluate     pharmacokinetics (PK) of oral BCX1777.   "
226934|NCT00823368|"     The subjects that meet the inclusion and exclusion criteria and consent to participate in     protocol 22001 will be offered participation in 22001A which will evaluate secreted protein     before and after treatment with STX209 and placebo to determine if they correlate with     effectiveness of treatment or susceptibility to treatment with STX209. These same subjects     will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection.     The investigators will study the DNA to determine if STX209 works better in people with     specific gene variations, or to find new gene variations that predict how well STX209 works.   "
226957|NCT00823667|"     RATIONALE: Palliative care may be more effective than standard care in improving quality of     life and symptoms in patients with lung cancer.      PURPOSE: This clinical trial is studying the effects of palliative care on quality of life     and symptom control in patients with stage I, stage II, or stage IIIA non-small cell lung     cancer that can be removed by surgery.   "
248548|NCT01108731|"     Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for     completing complex tasks relative to placebo.   "
226935|NCT00823381|"     The purpose of this study is to compare the effects of the antioxidant resveratrol to a     diet intervention (Calorie Restriction) to determine how each of them affects the following:     gene expression profile, cholesterol (lipids), how well the hormone insulin works to control     your blood sugar, and other blood and tissue markers of metabolic and cardiovascular health.      Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have     health benefits such as improving fat metabolism, insulin action, and possibly extending     lifespan. Resvida™ is the name for the dietary supplement containing the natural antioxidant     resveratrol. Resvida™ will be supplied by DSM Nutritional Products, Ltd.      Resvida™ is considered a dietary supplement, and therefore it is not an approved drug by the     Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug     Administration does not strictly regulate herbs and dietary supplements. The makers of     Resvida™ make no claim that this supplement is meant to treat any ailment.      Calorie restriction (CR) is a low calorie diet (about 30% fewer calories than the American     Dietetic Association (ADA) recommends). Calorie restriction has also been linked to health     benefits (enhanced cardiovascular and metabolic health) and an extended lifespan.      This study is designed to compare the health benefits of both resveratrol and CR and to     determine if resveratrol mimics some of the health benefits shown with CR.   "
226936|NCT00823394|"     The goal of this research study is to learn if certain factors may affect cancer rates among     African Americans. These factors include behavioral, social, and environmental factors     including diet and physical activity, cigarette smoking, cancer screening, health care,     neighborhood environment, and mental health.   "
226937|NCT00823407|"     The purpose of this study is to investigate the pharmacological and cognitive effects of MDA     in healthy humans.   "
226938|NCT00823420|"     A single centre randomised controlled trial investigating the influence of a novel     prematuration system (PMS) using a phosphodiesterase-3 inhibitor for in-vitro maturation of     oocytes   "
226939|NCT00823433|"     Pregnant,laboring women will receive 2 grams of oral penicillin V before delivery. At the     time of delivery of the infant, umbilical vein cord blood will be obtained from the umbilical     cord. These cord blood samples will be sent for bioassay of penicillin levels.   "
226940|NCT00823446|"     The purpose of this study is to perform a preliminary evaluation of the safety of Revera     Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.   "
226941|NCT00823459|"     A single-arm, one-stage phase II trial of RAD001 will be undertaken. Sixty patients will be     enrolled. The target population will be patients with a diagnosis of low-grade glioma who     experience a recurrence and who undergo a biopsy or subtotal resection at the time of     recurrence with pathologic evidence of recurrent glioma. The purpose of this study is to     accrue patients to evaluate a pharmacologic agent. The study drug RAD001 will be     self-administered (by the patients themselves). RAD001 will be administered orally as once     daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of     disease or unacceptable toxicity.   "
226952|NCT00823602|"     Literature suggests that GnRH antagonists are comparatively more often used in cycles which     have an unfavorable prior prognosis, and this protocol is an ideal one for poor responder     patients. Up to now, however not enough prospectives have been published to prove any     beneficial effect of antagonists on the first cycle assisted reproductive technique.      This prospective study will do to evaluate the efficacy of gonadotropin releasing hormone     antagonist in comparison with the standard long protocol in the first cycle of ART.      The investigators will randomize 160 patients undergoing ART for the first time . Group 1     (n=80) was stimulate with a standard long protocol and group 2 (n=80) stimulated with GnRH     antagonist and then result of ART compare in two group .   "
226953|NCT00823615|"     The purpose of this trial is to compare the performance of two multifocal contact lenses.   "
227075|NCT00818246|"     The purpose of this study was to determine whether light emitting diode (LED) therapy can     improve skin appearance of human subjects with aged/photoaged skin. A reduction in rhytid     depth as well as in skin surface roughness and in the degree of elastosis after LED     treatments was expected.   "
227076|NCT00818259|"     This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for     the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0     months to 17 years of age.   "
226942|NCT00823472|"     Background of the study:      Milder stimulation protocols have the advantage of being less expensive and more     patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to     lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild     stimulation protocols the expected number of oocytes retrieved will be lower, pregnancy rates     have shown to be similar possibly because embryo quality outfavours embryo quantity.      Objective of the study:      The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead     to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH     antagonist co-treatment started on a fixed day.      Study design:      Prospective randomized trial comparing two different starting days of ovarium stimulation     (day 2 versus day 5) for IVF treatment.      Intervention:      One group wil start on cycle day 2 with stimulation of the ovaries with recombinant FSH. The     other group will start on cycle day 5. Both group will start suppressing the gonadotrophin     production of the the pituitary gland on cycle day 6 with a GnRH antagonist.      Primary study parameters/outcome of the study:      Primary outcome parameter is number of top embryos per ovum pick up.      Secondary study parameters/outcome of the study:      Secondary outcome measures are duration of stimulation, cancellation rate, fertilization     rate, number of cumulus oocyte complexes obtained, number of mature oocytes obtained, number     of top embryos per started cycle, amount of IU recFSH, and clinical pregnancy rate.   "
226943|NCT00823485|"     The purpose of this study is to determine the impact of in situ fibrinolysis on the mortality     at 30 days in case of subarachnoid hemorrhage.   "
226956|NCT00823654|"     The purpose of this study is to see how the cancer treatment affects the ovaries. Cancer     treatment can make it hard for a person to conceive a child in the future. It may also bring     on early menopause. We will check blood levels of hormones that the ovaries produce. We will     do this before, during, and after the cancer treatment. We will also ask the patient to fill     out questionnaires about their menstrual cycle (periods) and information about your health     and pregnancies. This may help us learn which women will be more likely to have early     menopause.   "
226944|NCT00823498|"     The aims of the proposed study are to:        1. Examine how youth and their parents use and perceive three active living domains for          physical activity (PA): schools, recreation, and transportation environment;        2. Identify patterns and predictors of environmental perceptions of physical activity;        3. Compare and contrast youth evaluations of physical activity resources with research team          objective evaluations of physical activity resources;        4. Using above data, refine the conceptual framework of physical activity phenomena in          low-income minority communities guiding this research and develop items for a          quantitative survey measuring parental and youth environmental perceptions of physical          activity for a future trial with this population.   "
226945|NCT00823511|"     This transmission pilot study is a prospective study to determine feasibility of enrolling     female partners into an international transmission study. Companion study to MCC-13930.   "
226946|NCT00823524|"     RATIONALE: Giving an infusion of natural killer cells from a donor after a donor stem cell     transplant may help kill any remaining cancer cells after the transplant.      PURPOSE: This phase I/II trial is studying the side effects and best dose of donor natural     killer cells when given after a donor stem cell transplant in treating patients with advanced     cancer.   "
226947|NCT00823537|"     Power-assisted therapeutic electrical stimulation (TES) or conventional TES to upper     extremities in acute stroke patients were performed in a randomized controlled trial. The     changes in finger and hand function will be evaluated. The hypothesis is that a     power-assisted TES is more effective than a conventional TES.   "
226948|NCT00823550|"     This is a randomized, open label, phase IV, multicenter study for efficacy and safety of     lamivudine versus entecarvir therapy in HBV-related advanced liver disease patients with high     viral load and normal or slightly elevated transaminase.   "
226949|NCT00823563|"     This is a research study evaluating possible causes of chest pain (or an anginal equivalent,     such as fatigue resulting in a decrease in exercise tolerance, shortness of breath, or back,     shoulder, neck, or jaw pain) in people with no evidence of significant coronary artery     disease on their coronary angiogram (pictures of the blood vessels in the heart). The purpose     of the research study is to determine if there is diffuse atherosclerosis (plaque) not     appreciated by angiography, or if the coronary endothelium (lining of the blood vessels in     the heart) and/or microcirculation (small vessels in the heart that are not easily seen with     an angiogram) are not functioning properly in those who have chest pain (or an anginal     equivalent), but normal coronary arteries on angiography. Specifically, we are interested if     these findings are more common in women than men.   "
226950|NCT00823576|"     Because local anesthetic infiltration has not been comparated to continuous infusion after     spine fusion surgery, the investigators designed this study to determine whether this     technique could enhance analgesia and improve patient outcome after posterior lumbar     arthrodesis.      The Main Objective of the study is to compare the evolution of the postoperative levels of     pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an     infiltration single shot of local analgesic (Ropivacaïne), one receiving a single shot     infiltration and a continuous infiltration of Ropivacaine during 48 hours.      In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL,     and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h.      The secondary outcomes are the consumption of morphine,the rate of the nausea and the     postoperative vomits, the delay up to the first rise, the quality of the sleep, the duration     of hospital stay and the persistence of residual pain.   "
226951|NCT00823589|"     Ageing is associated with vulnerability against infections leading to increased morbidity     with risk of death. Innate and adaptive immunities are altered with ageing responsible of     deficits in immune response against pathogens and after vaccination, and favouring the     elderly vulnerability against a new pathogen with increased bacterial, viral, and fungal     infections.      If immunity has been widely studied in immunosenescence, there are few prospective,     comparative studies with elderly ill patients. Moreover among these studies, pathologies are     not well defined.      The main objective of our project is to compare the immune state of elderly hospitalised     subjects in an acute geriatric unit to the immune state of elderly healthy subjects selected     with strict criteria, in order to precise the impact of polypathology and of various     pathologies on immunity state.   "
226980|NCT00823966|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the     incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect     the safety and/or efficacy of this drug.   "
227588|NCT00831441|"     The purpose of this study is to determine if apixaban is superior to placebo for preventing     cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a     recent acute coronary syndrome   "
226954|NCT00823628|"     In the treatment of coronary heart disease which is the major cause of heart attack, direct     mechanical treatment with catheters such as the coronary angiography, coronary balloon     intervention and stenting intervention are the mainstay of therapy in recent years. In that     procedures, the investigators should use the contrast media, and it may cause kidney toxicity     especially in the patients with underlying kidney disease and decreased kidney function. The     investigators intended to find out which contrast agent has less kidney toxicity in the     catheter based treatment of coronary arterial diseases in patients with underlying decreased     kidney function   "
226955|NCT00823641|"     An open-label, non-randomised, uncontrolled, proof-of-concept study of eight patients with     'definite' HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Eligible     patients will have either early disease (of less than 2 years duration) or progressive     disease (with observed clinical deterioration during the preceding 3 months.      Following 2 baseline assessments including Magnetic Resonance Imaging (MRI) of the spinal     cord and a lumbar puncture for examination of the fluid around the brain (CSF) participants     will be treated with a total of 7 infusions of the anti-TNF-alpha antibody infliximab over a     period of 48 weeks. After the last on therapy assessment at 48 weeks participants will be     followed up for a further 24 weeks. Study assessments will be clinical, virological,     immunological and radiological. MRIs of the spinal cord will be obtained at weeks 12 and 72.     CSF will be examined, on therapy, at week 12.   "
226958|NCT00823680|"     This 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients     with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization     period for glucose control, patients will be randomized to one of 5 groups to receive     a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po     qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is < 3 months,     and the target sample size is 100-500 individuals.   "
226959|NCT00823693|"     The purpose of this study is to determine whether Bimosiamose Cream is safe and effective in     the treatment of plaque type psoriasis.   "
226960|NCT00823706|"     The primary purpose of this study is to assess the prevalence of asymptomatic chronic angle     closure in high risk Caucasian individuals, namely those with hyperopia. A secondary purpose     is to assess whether specific demographic or ocular-anatomic parameters in this population     are associated with a higher risk for angle closure.   "
226961|NCT00823719|"     The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in     combination with ifosfamide, carboplatin, etoposide (ICE) or dexamethasone, cytarabine,     cisplatin (DHAP) salvage chemotherapy regimens in subjects with relapsed or refractory     diffuse large B cell lymphoma (DLBCL) who are eligible for autologous stem cell transplant.   "
226962|NCT00823732|"     RATIONALE: Palliative care may be more effective than standard care in improving quality of     life and symptoms in patients with lung cancer.      PURPOSE: This clinical trial is studying the effects of palliative care on quality of life     and symptom control in patients with stage IIIB or stage IV non-small cell lung cancer that     cannot be removed by surgery.   "
226963|NCT00823745|"     This is a phase 1 study to assess the routes of elimination of a single oral dose of [14C]     PF-00868554 and to characterize the metabolic profile following single dose administration.   "
226964|NCT00823758|"     Introduction to Study Objectives:      In a joint collaboration of the Centers for Education and Research on Therapeutics (CERTS) at     The University of Pennsylvania and the M.D. Anderson Cancer Center, this study proposes to a)     combine detailed but under-utilized existing large datasets and b) collect new primary data;     together, resulting two data resources will advance our ability to describe, study, and     understand the effectiveness and safety of pharmaceuticals received by pediatric patients in     hospitals, and how to improve the safe use of over-the-counter (OTC) acetaminophen in home     settings.      The CERTS study is organized into two projects: Project I and Project II.      For this protocol, the study focus will be Project II-Phase 1.      Project II will seek to qualitatively describe the patterns of use and misuse of     over-the-counter OTC acetaminophen, through information gathered from consumers of various     age groups, as well as professional key informants.      Project II-Phase 1      Objective 1:      -Qualitatively explore knowledge, attitudes, beliefs, and practices regarding adult and     adolescent self-administration of OTC acetaminophen, and parental administration of OTC     acetaminophen to children.      Objective 2:      -Qualitatively explore experiences and practices of key professional informants, including     physician and pharmacists, with respect to communicating information on the administration     and risks of OTC acetaminophen to consumers and patients.   "
226965|NCT00823771|"     This is a pilot study assessing the role of the general practitioner in performing follow-up     reviews on men who have recently completed radical radiotherapy for prostate cancer. This     will be measured primarily by assessing any changes to the patient's health-related quality     of life which will be evaluated by the completion of questionnaires by the participant at     each review visit. The study aims to confirm that patient outcome is identical, independent     of whether follow-up is performed by a specialist or the patient's General Practitioner.   "
226981|NCT00823979|"     This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir     and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as     etravirine in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase     inhibitor in HIV-1 infected patients who have been previously treated with antiretroviral     drugs and have NNRTI resistance mutations.   "
226966|NCT00823784|"     Haemorrhoids have, in literature, extremely high ranges of prevalence, 4,4% to 36% and there     is a debate on the best treatment for III degree hemorrhoids. The Stapled Hemorrhoidopexy is     indicated in grade III haemorrhoids due to its advantages vs. other techniques in pain     reduction and time before resume of normal activity. The new technique of Doppler guided     trans-anal arterial ligation (THD) appear to be another important therapeutic tool thanks to     its scarce complications, the minimally invasive procedure and efficacy of the short term     results. The rationale of the two surgical techniques is different: in fact, the Stapled     Hemorrhoidopexy is based on the hypothesis that the mucosal and sub/mucosal resection and     stapling can cure the prolapse, etiologic factor of haemorrhoids; on the other hand, the     interruption of the arterial inflow of hemorrhoids by THD reduces hemorrhoidal tissue. Aim     of this study is to compare 2 techniques: The doppler guided transanal haemorrhoidal     dearterialisation with the THD device and the stapled Haemorrhoidopexy (according to Longo)     for III degree (Goligher) haemorrhoid, not regarding the number of prolapsed piles   "
226967|NCT00823797|"     This phase II trial studies how well bendamustine hydrochloride works in treating patients     with anaplastic glioma or glioblastoma that has come back (recurrent) or growing, spreading     or getting worse (progressive). Drugs used in chemotherapy, such as bendamustine     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing.   "
226985|NCT00824044|"     The purpose of this research study is to find out if a test can predict whether someone with     depression will get better with treatment. We also want to find out whether there are changes     in the brains of depressed patients having different types of treatment (drug therapy vs.     talk therapy). We hope that a test called QEEG (Quantitative Electroencephalogram) can tell     us if a treatment is going to work, even before the person starts to feel better.      Hypothesis 1: Response to treatment will correlate with changes in QEEG metrics.      Hypothesis 2: QEEG parameters, different from those that predict response to pharmacotherapy,     will be associated with response to CBT.   "
226986|NCT00824057|"     The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on     the blood levels of midazolam and caffeine in healthy volunteers   "
249239|NCT01118377|"     This study evaluated the effect of capecitabine and concomitant radiation therapy in children     with newly diagnosed brainstem gliomas.   "
226968|NCT00823810|"     Measuring tumor response to treatment based on computed tomography (CT) and/or magnetic     resonance imaging (MRI) has been a widely debated issue (response criteria in solid tumors     [RECIST] and World Health Organization criteria). Furthermore, early identification of     nonresponding patients is of great importance because the rates of response of common     malignant solid tumors to chemotherapy are in the range of only 20-30%. Therefore,     quantitative imaging of tumor metabolism with 18F-FDG PET/CT may provide important advantages     and thus reduce side effects and costs of ineffective therapy. However, the evidence to date     for the use of 18F-FDG-PET/CT with this indication is limited.      The purpose of the present trial is to determine the impact of 18F-FDG PET/CT in the     management of advanced colorectal cancer. The aim is also to confirm whether a metabolic     response can be used as a surrogate end point in monitoring treatment response in this cancer     type.      The study consists of 40 patients with advanced colorectal cancer patients. All patients will     be studied with 18F-FDG PET/CT combined with diagnostic contrast enhanced abdominal CT before     the start of chemotherapy and re-evaluated 4-5 weeks after the initiation of therapy. Effect     of this metabolic and anatomic change in therapy are evaluated and correlated to survival,     morbidity, and treatment -related costs. Histopathologic confirmation of response is     evaluated whenever possible. The data will be collected between 2008 and 2012.   "
226969|NCT00823823|"     It is recognized that fractures of the distal radius and forearm occur in approximately one     in 100 children and adolescents every year. Though closed manipulation and cast     immobilization of displaced injuries is the mainstay of treatment in the majority of cases,     the optimal type of cast remains debatable. Though well-molded casts theoretically provide     the best ability to maintain fracture alignment, risks of circumferential immobilization in     acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce     these risks, but the effect on fracture stability is unknown. The proposed investigation     seeks to address the simple question of whether circumferential or bivalved casts provide the     best outcomes.   "
226970|NCT00823836|"     To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole     immediate release (IR) tablets with advanced Parkinson's disease in conjunction with L-dopa     in a double-blind, parallel group comparison study.   "
226971|NCT00823849|"     1. To evaluate the efficacy of Cilostazol and Probucol alone and in combination on          atherosclerosis related biomarker        2. To evaluate the safety of Cilostazol and Probucol alone and in combination on          atherosclerosis related biomarker   "
226972|NCT00823862|"     To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101     alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.   "
226973|NCT00823875|"     Randomized, control, open label, multicentre clinical study. The patient who are in     accordance with subject inclusion and exclusion criteria will be randomized to A group:     Routine treatment B group: Routine treatment+ Cilostazol; C group : Routine treatment +     Probucol; D group: Routine treatment+ Cilostazol+ Probucol .   "
226974|NCT00823888|"     The overall objective of this project is to determine whether the provision of a pneumatic     knee brace in patients with medial knee osteoarthritis (OA) improves knee mechanics.     Secondary objectives will be to assess if the brace relieves knee pain and improves function.     We will test the hypothesis that compared to the control treatment (see below for the     definition) the use of a pneumatic knee brace is effective in medial knee OA.   "
226975|NCT00823901|"     The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin     0.025% Gel are effective and safe in the treatment of papulopustular rosacea.   "
226976|NCT00823914|"     Objective of the study is to create and validate Chronic Quality of Life (CQOL) index that     explores habits, career paths and other life choices psoriasis patients make as a result of     coping with their disease that may not be impacted by therapy implemented at a given point in     time.      - The investigators think this data will show that patients who were diagnosed at a young age     will have worse chronic quality of life.   "
226977|NCT00823927|"     This study is being done to examine lung function changes in individuals with HIV infection     and to understand why individuals with HIV have increased risk of lung damage from cigarette     smoking.   "
226978|NCT00823940|"     The study will investigate whether GSK1362885 is safe and well-tolerated when administered to     normal healthy subjects. The study will also measure blood levels of the study drug to     determine how the body processes the drug (pharmacokinetics) and what effects the drug has on     the body (pharmacodynamics).   "
226979|NCT00823953|"     Diabetes is a common disease which has been treated by traditional medicines for centuries     before modern medicine became available. A very common remedy for Diabetes Mellitus in     different cultures is momordica charantia (karela or Bitter gourd). The use of alternative     medicine is common among Pakistani population. This study was planned to find out the effect     of administering freeze dried powder of momordica charantia for three weeks on the glycemic     profile and insulin resistance of treatment naiive patients with mild Type 2 diabetes.   "
226982|NCT00823992|"     This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared     to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with     metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once     weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their     prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will     be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly)     The anticipated time on study treatment is 12 months, and the target sample size is 100-500     individuals.   "
226983|NCT00824005|"     Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all     people with CAD are eligible for today's standard treatments. One new treatment approach uses     stem cells—specialized cells capable of developing into other types of cells—to stimulate     growth of new blood vessels for the heart. This study will determine the safety and     effectiveness of withdrawing stem cells from someone's bone marrow and injecting those cells     into the person's heart as a way of treating people with CAD and heart failure.   "
226984|NCT00824031|"     Non-interventional, multicenter, cross-sectional study to evaluate the mental care received     by schizophrenic patients and their caregivers in Spain irrespective of the drug prescribed.   "
226988|NCT00824083|"     The purpose of the study is to assess the functional outcome, quality of life and late     sequelae in a representative sample of 600 long-term survivors of Ewing sarcoma and to build     a unique clinical and functional data pool of the underlying cohort of 3000 Ewing sarcoma     patients with a follow-up of 3 decades.   "
226989|NCT00824096|"     Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine     guidelines for extubation may be obtained through this study.   "
226990|NCT00824109|"     The purpose of this prospective trial is to demonstrate the safety and performance of the     Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive     diseases of the abdominal aorta.   "
226991|NCT00824122|"     This study proposes to identify patients who developed RMS with vancomycin infusion, and     determine presence or absence of variant alleles involved in histamine biotransformation. The     implications of this study are important, as identification of variant alleles in these     patients, may alter the current standard of care for vancomycin infusions.      The hypothesis of this study is that the development of red man syndrome (RMS) during receipt     of intravenous vancomycin is associated with the presence of variant alleles for genes     involved in the histamine pathway. The primary outcome that will be measured will be the     history of RMS and the presence or absence of variant alleles for the genes responsible for     histamine metabolism (i.e. histamine n-methyltransferase and diamine oxidase). As a secondary     endpoint, the study will also attempt to determine the incidence of RMS in pediatric     patients.   "
226992|NCT00824135|"     Patients with refractory hematologic malignancies including those who develop recurrent     disease after allogeneic hematopoietic stem cell transplantation (HSCT) have a dismal     prognosis. Historically, both regimen-related mortality and disease recurrence have been     significant causes of treatment failure in this heavily pre-treated patient population. The     investigators institution has utilized mismatched family member donors for these patients for     several reasons: (1) Only 30% of patients have matched related donors available; (2)     transplantation can be performed more rapidly since the time to unrelated donor     trans-plantation averages 3 to 4 months; (3) the alloimmune reactivity of natural killer (NK)     cells following haploidentical HSCT has been shown to reduce relapse rates in certain patient     groups; and, (4) no other curative treatment options are available.      In the present trial, the investigators propose a novel conditioning regimen using     clofarabine in an effort to enhance cytotoxicity while simultaneously reducing regimen     related toxicity. In this phase I trial, the goal is to determine the maximum tolerated dose     (MTD) of clofarabine when used in combination with melphalan and thiotepa pre-transplant.   "
226993|NCT00824148|"     The purpose of this study is to determine whether a real-time continuous glucose monitoring     system is able to improve HbA1c in patients suffering from type 1 diabetes compared to     conventional finger prick glucose measurements. In addition it will investigate whether     number of episodes with serious hypoglycemia is changed in those same patients, and whether     quality of life (health status and treatment satisfaction) increases.   "
226994|NCT00824161|"     The purpose of this study is to evaluate progression free survival primarily. The secondary     objectives are to evaluate the antitumor activity, as assessed by objective tumor response,     duration of clinical benefit, overall survival, and the safety profile of TAS-109   "
227039|NCT00824759|"     Tissue hypoxia is the only accepted trigger for erythropoietin (EPO) production. However, in     healthy subjects EPO concentrations have also increased after oxygen breathing. The aim of     our study is to confirm these observations.      Besides its main function in erythropoiesis, EPO has also shown tissue protective effects.     The second goal of our study is to observe the cardioprotective effects of increased     endogenous EPO, induced after normobaric oxygen breathing.   "
227040|NCT00824772|"     Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in     dose requirements of fentanyl for postoperative pain control. This study aims to reveal the     genetic factors affecting the variable requirements of fentanyl during postoperative period.   "
226995|NCT00824174|"     Objectives:      The purpose of this study is to obtain descriptive information about the nature and extent of     body image concerns among surgical patients with head and neck cancer, satisfaction with care     received regarding body image issues, and interest in psychosocial services targeting body     image disturbance. Findings from this study provide important preliminary data to guide     future large scale research on the critical, yet understudied, psychosocial issue of body     image functioning for head and neck cancer patients. Information obtained from this study can     specifically be used to facilitate the development of appropriate disease-specific body image     instruments and to determine the need for body image focused psychosocial interventions to     enhance quality of life and the survivorship experience for these patients.      Primary Aims        1. To characterize the nature and extent of body image concerns in surgically treated          patients with head and neck cancer and determine preferences for psychosocial          intervention.        2. To compare body image and quality of life outcomes for patients at different time points          relative to initiation of treatment. Specific time points of interest are pre-treatment,          within one year of initial surgical treatment, and greater than 1 year following initial          surgical treatment.      Secondary Aim      1. To compare body image and quality of life outcomes for patients with oral cavity,     cutaneous, and midface cancers.   "
226996|NCT00824187|"     The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo     in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD).   "
226997|NCT00824200|"     Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom.     Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy     for LUTS in men, but α-blockers offer only limited reductions in nocturia. While combinations     of multiple drugs could be used, many individuals wish to take fewer medications.      Participants in the BEDTiMe Nocturia Study will undergo a series of visits during which they     will receive a combination of either standard drug therapy (or placebo) and a behavioral     intervention tailored to help with nocturia or problems with nocturia. Participants will be     evaluated for outcomes at 12 weeks and followed for six months.      This study will yield important information related to alternative treatments of nocturia in     men, as well as novel information regarding the clinical importance of these nocturia     reductions. This study has the potential to alter standards of care.   "
226998|NCT00824213|"     The investigators propose to investigate the performance of the image reconstruction software     with resolution recovery correction for bone SPECT studies. The investigators estimate that     in only 30 minutes, using this new technique of collimator de-blurring, one could perform a     fully 3-dimensional SPECT whole-body bone study, essentially obviating the necessity for     doing planar bone studies.      In the scope of the proposed project, the investigators group aims to test the hypothesis     that one can perform a Tc-99m whole-body SPECT study in the same time as a regular routine     planar bone study, with greater localization accuracy, and greater lesion detection.      To establish a gold standard necessary to assess the performance of the SPECT bone scans,     the investigators will compare number of malignant lesions detected in patients who are     proven to have metastatic skeletal bone lesions on PET F-18 whole-body scans, with whole-body     Tc-99m SPECT lesions. The investigators also propose to compare the detection of SPECT scans     with standard planar bone scans. This will allow for two major comparisons (a) the accuracy     of SPECT bone studies compared to planar bone studies, and (b) the accuracy of SPECT bone     scans compared to F-18 PET studies. Most prior studies purporting to show the superiority of     F-18 bone scans to Tc-99 bone scans were done only against either planar scans or a     combination of planar scans and partial SPECT studies over the spine. We anticipate that F-18     bone scans, due to the higher counting statistics of PET agents, will show more lesions than     SPECT, but the exact increase in sensitivity has never been compared to whole-body SPECT     scans.   "
226999|NCT00824226|"     Study hypothesis: supplementary magnesium may influence the blood calcium level in treated     hypoparathyroid patients. Patients will be treated with supplementary magnesium (350 mg/day)     for 3 weeks. Calcium and other relevant blood parameters will be measured before the     treatment, at the end of treatment and 2 weeks after stopping treatment.   "
227000|NCT00824239|"     Sedation is very important in critical care. Critically ill patients are submitted to many     stressor factors that have potential to affect longterm outcomes. However, oversedation is     associated with increased morbidity, including increased time of mechanical ventilation and     ICU stay and longterm psychological complications. Daily interruption of sedation is     associated with less time under mechanical ventilation and less posttraumatic stress     disorder. Intermittent sedation, when compared with continuous sedation, is also associated     with decreased time of mechanical ventilation. The aim of this study is to compare     intermittent sedation with daily interruption. Our primary endpoint is free-days of     mechanical ventilation in 28 days.   "
227001|NCT00824252|"     The goal of this research study is to look at social and relationship factors that may affect     the quality of life of patients with head and neck cancer and their spouses.   "
227002|NCT00824265|"     The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to     fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).   "
227003|NCT00824278|"     Medical illnesses and treatments can cause distress in patients, and medical professionals     are very interested in identifying distress quickly to ensure that a patient can receive     appropriate support and treatment. Adult patients often use a screening tool known as the     Distress Thermometer to indicate the causes and levels of distress they feel. However, little     work has been done on how to assess distress in pediatric patients. This study will     investigate the effectiveness of the Distress Thermometer as a tool to accurately measure     distress in pediatric patients, and determine whether primary caregivers and physicians can     also use the Distress Thermometer to accurately gauge a patient s levels and sources of     distress. The study will also investigate the effectiveness of the Distress Thermometer     compared with other means of measuring fatigue, mood, and pain levels.      This study will include approximately 90 patients between 7 and 21 years of age who are     currently enrolled in a National Institutes of Health pediatric research study. It will also     include responses from the primary caregivers and primary medical providers of the patients     involved in the study.      All patients will complete the Distress Thermometer s self-reported distress scale and other     standardized measures of anxiety, depression, fatigue, and pain. In addition, patients     between 18 and 21 years of age will be asked to assess the benefits and negative effects of     participating in psychosocial research.      On the same day, the patient s primary caregiver and primary medical provider will complete a     Distress Thermometer survey to estimate the patient s distress level. If either the patient     or the primary caregiver indicate high levels of distress or mood symptoms, the researchers     will offer them an opportunity to speak with a mental health professional. The primary     medical provider will also receive a copy of the responses reported on the patient s Distress     Thermometer.   "
227004|NCT00824291|"     This is a multicenter study to assess the health and well-being in subjects who are     outpatients with major depressive disorder that take desvenlafaxine succinate sustained     release (DVS SR) or placebo for 12 weeks.   "
227005|NCT00824304|"     The hypotheses of this study are:        1. Compared to children who received a placebo, children who received iron or zinc or iron          and zinc combined will perform better on cognitive tests and will have better growth          status at ages 8 to 10 years.        2. Compared to children who received iron or zinc alone, children who received iron and          zinc combined will perform differently on cognitive tests and will have different growth          status at 8 ages 8 to 10 years        3. Compared to children who had poorer iron and zinc status or poorer growth status before          and after supplementation during infancy, children who had better iron and zinc status          or better growth status before and after supplementation during infancy will perform          better on cognitive tests and will have better growth status at ages 8 to 10 years.        4. Compared to children who have lower iron and zinc status, poorer growth status, or low          animal source intake at ages 8 to 10 years, children who have higher iron and zinc          status, better growth status, or high animal source intake at ages 8 to 10 years will          perform better on cognitive tests and will have better growth status.   "
227006|NCT00824317|"     The purpose of this study is to compare the response to methylphenidate treatment of children     with two different subtypes of ADHD.   "
227007|NCT00824330|"     Older persons with diabetes have a harder time maintaining blood pressure when standing up.     When blood pressure drops when standing up, fainting may occur. This study will see how     regular exercise can improve the ability of the body to keep blood pressure up when standing.     We want to see how this improvement varies with a home-based walking program.   "
227008|NCT00824343|"     This is a single arm phase II trial to study the efficacy and safety of a Cdk inhibitor     P276-00 in the treatment of squamous cell carcinoma of head and neck. Patients with recurrent     or metastatic disease that is unresectable and incurable by radiation will be enrolled.     Thirty eight evaluable patients need to be enrolled in the study. All patients will receive     protocol treatment i.e. P276-00 as an intravenous infusion from day 1 to day 5 and from day 8     to day 12 in each 21 day cycle till progression of disease or unacceptable toxicity. Safety     evaluations by means of recording vitals, physical examination and lab investigations like     hematology and clinical chemistry will be undertaken at regular intervals in each cycle.     Tumor measurements by spiral CT scan will be undertaken at baseline and at the end of every 2     cycles for response evaluation by RECIST criteria. All patients will be followed up for     survival status till one year of cycle 1 day 1.   "
227011|NCT00824382|"     The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL     inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese     patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum     dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic     evaluations.   "
227012|NCT00824395|"     The purpose of this research study is to investigate the genetic causes of diabetes.     Specifically, we are interested in the mitochondrial genome and how variants in the     mitochondrial genome influence a person's risk to develop diabetes and metabolic syndrome.   "
227013|NCT00824408|"     The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with     pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who     relapsed after or failed first-line platinum based therapy.      The secondary objectives are to identify the acceptable dose of BI 6727 in combination with     pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727     monotherapy arm is closed to further recruitment.   "
227014|NCT00824421|"     This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as     efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected     patients who have not been previously treated with antiretroviral drugs.   "
227015|NCT00824434|"     Compile acute (30-day) clinical outcomes data and 9-month angiographic and intravascular     ultrasound (IVUS) data for the PROMUS Element™ Everolimus- Eluting Coronary Stent System in     the treatment of patients with a single de novo atherosclerotic lesion   "
227016|NCT00824447|"     This study is designed to give additional information on the efficacy, safety and local     effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during     a second grass pollen season.   "
227017|NCT00824460|"     The purpose of this study is to investigate the ability of different doses of PA21 to lower     serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.   "
227018|NCT00824473|"     The purpose of this study is to determine if one allergy medication (0.15% azelastine     hydrochloride) is more effective than Placebo alone   "
227019|NCT00824486|"     This project seeks to determine the efficacy of safety education using a safe home model. The     4 X 8 ft. model is designed to look like a house; each of 4 rooms has a focused safety     message. Families will be enrolled in the clinic and randomized to one of two groups, the     safe home model group and the printed safety education materials (TIPP materials) group. The     investigators will compare the retention of safety information among caregivers instructed     using these two methods. The hypothesis is that families in the safe home model group will     have improved retention of safety information.   "
227020|NCT00824499|"     The purpose of this study is to determine whether regional implementation of shared care with     respect to type 2 diabetes is feasible, effective and cost-effective.   "
227021|NCT00824512|"     The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus     placebo in patients suffering from Friedreich Ataxia   "
227022|NCT00824538|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with     stage I, stage II, or stage III breast cancer who have tumor cells in the bone marrow.   "
242768|NCT01033331|"     The purpose of this study is to determine if the treatment with valproic acid can increase     the muscle strength and motor ability of children with spinal muscular atrophy.   "
227023|NCT00824551|"     The blinded RCTstudy aims to:        -  Determine the effects of HBOT on burns conversion for patients who have fresh thermal          burns injury using the LDI.        -  Objectively determine the proportion of burns conversion in areas of partial thickness          burns for early thermal burns injury in both arms of the RCT.        -  Study the effects of HBOT on immunological markers IL-1, IL-2, IL-4, IL-6, IL-8, IL-10,          TNF-α and TGF-β ( comparison between both arms and 2 assessment points).        -  Study the effect of HBOT on haematological markers including procalcitonin ,albumin,          lymphocyte counts, neutrophil count, and macrophage count.        -  Study the effects of HBOT on histology specimens in quantifying P53 protein, leukocyte          and macrophage infiltration, burns depth assessment and vascular endothelial growth          factor (VEGF) and inducible nitric oxide synthase (iNOS) .        -  Study the effects of HBOT on bacteriology of tissue culture in areas of deep dermal          burns.   "
227024|NCT00824564|"     Tranexamic acid has been shown to reduce postoperative blood losses and transfusion     requirements in a number of types of surgery. Most trials in orthopedic surgery have been     conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the     effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture     surgery, primarily fracture shaft of femur.   "
227025|NCT00824577|"     Use 24hr Holter ECG, ultrasound and cardiac fibrosis markers in the chronic kidney disease     patients   "
227026|NCT00824590|"     This study is to compare the pharmacokinetics of Dimebon in subjects with severe renal     impairment to subjects with normal renal function after oral administration of a single oral     20-mg dose of Dimebon. This study is also to assess the safety and tolerability of a single     oral 20-mg dose of Dimebon in subjects with severe renal impairment and subjects with normal     renal function.   "
227027|NCT00824603|"     The purpose of this study is to determine if a continuing medical education (CME) program can     change primary care providers' use of insulin therapy - their confidence in selecting doses     and engagement of patients in the decision making as to whether to initiate insulin therapy.   "
227028|NCT00824616|"     The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking     insulin for Type 2 Diabetes.   "
227029|NCT00824629|"     The purpose of this study is to evaluate two types of embryo transfer procedure.      The investigators will compare direct embryo transfer against afterloading embryo transfer.   "
227030|NCT00824642|"     The objective of this study is to investigate the effectiveness of Acu-TENS (Transcutaneous     electrical nerve stimulation applied on acupoints) on the post- exercise expiratory flow rate     and exercise performance on the subjects with exercise.   "
244611|NCT01057251|"     The primary object of this study is to evaluate the efficacy and safety of 6 weeks of     nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.   "
227031|NCT00824655|"     The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate     Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will     also assess the immunological response (measure the amount of antibodies, i.e. proteins that     fight off germs) produced by children after they have been given the 13-valent pneumococcal     vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site     will be assessed during the study.   "
227032|NCT00824668|"     This trial is conducted in Europe. The aim of this clinical trial is to compare the 24-hour     pharmacodynamics/ pharmacokinetics of biphasic insulin aspart 30 (BiAsp 30) thrice daily     treatment with that of a basal-bolus treatment with insulin glargine and insulin glulisine in     type 2 diabetic subjects.      Pharmacodynamics is the glucose-lowering effect of the study medication over the entire     observation phase from the time of administration and the efficacy period while the     pharmacokinetics is the amount of the study insulin that can be determined in the blood.   "
227033|NCT00824681|"     The purpose of this study is to investigate the efficacy of music therapy in assisting with     the coping and adjustment of children of adults with major burns. The investigators     hypothesized that there will be a significant decrease in anxiety levels between those     children who participated in music therapy compared to non-participants.   "
227034|NCT00824694|"     To show that a structured treatment plan based upon Accu-Chek 360 View has a favorable effect     on physician decision-making and HbA1c for patients on oral hypoglycemic agents (OHA) or     insulin for type 2 diabetes (T2D).      Hypothesis 1: Compared to controls, intervention subjects will undergo a greater number of     medication changes and have a lower HbA1 at the conclusion of the study.      Hypothesis 2: Higher rates of monitoring at entry will be associated with lower CHO     consumption, lower percent body fat, higher medication compliance, and higher physical     activity levels.      Hypothesis 3: Patients with lower rates of monitoring at entry will have higher rates of     depression, more likely to have an external locus of control, and express greater fear about     self-testing.   "
227035|NCT00824707|"     This study is working to research the efficacy and significant of the anti-virus therapy in     the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish     treatment standards of anti-virus therapy in PLC.   "
227036|NCT00824720|"     The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug     delivery system in open-angle glaucoma or ocular hypertension.   "
227037|NCT00824733|"     RATIONALE: Biological therapies, such as agatolimod, may stimulate the immune system in     different ways and stop tumor cells from growing. Monoclonal antibodies, such as trastuzumab,     can block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Giving agatolimod together with trastuzumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving agatolimod together with trastuzumab     works in treating patients with locally advanced or metastatic breast cancer.   "
227038|NCT00824746|"     A single arm, open label, prospective, phase II trial of Gefitinib retreatment for the     advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And     progressive disease should be observed with at least one prior regimen following previous     gefitinib failure.      Primary endpoint        -  to assess Disease Control Rate (Remission + Stable disease)      Secondary endpoints        -  to assess the progression free survival   "
227041|NCT00824785|"     To determine whether adding panitumumab, an antibody against the epidermal growth factor     receptor (EGFR), to standard chemotherapy with epirubicin, oxaliplatin and capecitabine     (EOX), improves the duration of survival of patients with advanced stomach and oesophageal     cancer.   "
227042|NCT00824798|"     Joint damage secondary to recurrent haemarthroses and chronic synovitis represents the     commonest clinical manifestation of haemophilia. Incapacitating pain, loss of joint stability     and mobility, axial deviation, deterioration and decreased function are the most frequent     complains in patients with severe haemophilic arthropathy In this context, the purpose of our     study is to examine and analyse specific changes in gait in patients suffering from     haemophilic arthropathy and determine the impact on health-related quality of life in terms     of conceptual components of pain and stiffness, psychosocial stress, disability, and activity     limitations as recommended by the International Classification of Function (ICF) recently     published by the World Health Organization.   "
227043|NCT00824811|"     Objective:      To evaluate the safety and efficacy of topical cyclosporine eye drops (Restasis®) for the     treatment of epiphora caused by canalicular stenosis secondary to Docetaxel (Taxotere®)     treatment for various cancers.   "
227044|NCT00824824|"     We have completed a study in which we examined the response of the retinal circulation to     changes in posture from sitting to lying down in patients with primary open angle glaucoma     (POAG). This alteration in position produces changes in the local blood pressure at the     entrance to the retinal vasculature. In a healthy retina, the vasculature adapts by dilating     and constricting in order to maintain a steady blood flow rate. In an eye with POAG, this     often does not occur. As a result, there are large fluctuations in blood flow which may     produce the retinal neuronal damage associated with glaucoma.      The purpose of this study is to demonstrate that topical anti-glaucoma treatments with agents     that have vasoactive as well as IOP-lowering effects can have a beneficial effect on     maintaining a steady retinal blood flow rate even when there are changes in local blood     pressure.   "
227045|NCT00824837|"     The purpose of this study is to determine whether a novel haemodialysis membrane, compared     with the standard dialysis membrane, will increase the removal of beta2-microglobulin in     chronic dialysis patients.   "
227046|NCT00824850|"     The purpose of this study is to assess the late immune response to further doses of     pneumococcal conjugate vaccine more than 10 years after primary immunization with Prevnar     (7vPnC) in infancy, as compared with individuals who did not receive Prevnar in infancy (the     Prevnar naive cohort which received MnCC). The study will take place at a single study     center. Study participants must have participated previously in a specific Wyeth Prevnar     study (Study D118-P8) and must still be enrolled in the Northern California Kaiser Permanente     (NCKP) health plan.   "
228511|NCT00846976|"     This is an open label, single-centered treatment protocol designed to monitor the safety of     patients treated with a 200 mg daily dose of CASODEX. Patient will receive CASODEX as long as     physician feels that he is benefiting from this form of therapy.   "
227047|NCT00824863|"     Pityrosporum folliculitis presents as fine superficial follicular pustules and papules on the     trunk and upper extremities. Ketoconazole 2% foam was recently approved for the treatment of     seborrheic dermatitis in immunocompetent patients 12 years and older. Ketoconazole 2% foam is     felt to work by reducing the number of pityrosporum yeast organisms. Safety and efficacy of     ketoconazole 2% foam treatment for this fungal infections has not been established. This     study is to demonstrate efficacy and safety in the treatment of pityrosporum folliculitis.   "
227048|NCT00824876|"     The investigators want to investigate the effect of anaesthesia, on the ability to maintain     upright posture immediately after surgery in mamma cancer patients.      The investigators hypothesis is, that a standard anaesthesia does not effect the ability to     maintain upright posture right after surgery.   "
227049|NCT00817908|"     Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a     transplant. Serious infections due to CMV can affect many parts of the body including the     lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have     evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or     valganciclovir). Despite this, there are a chance that CMV infection may cause problems in     the future. The purpose of this study is to assess how well patients'immune systems responds     to the CMV virus, so that in the future it may be possible to predict which patients are at     highest risk of CMV.   "
227050|NCT00817921|"     Purpose of the study:        1. To evaluate the effect of prematurity on renal function in 5 years old children        2. To compare former premature children treated by ibuprofen in the neonatal period to          controls   "
227051|NCT00817934|"     The purpose of this study is determine if the AB Prep (a 16 tablets colon cleansing prep), is     an effective, and safe colon cleansing prep in preparation for colonoscopy, and severe     constipation.   "
227052|NCT00817947|"     High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucous     clearance compared with control. These observations led to the development of 'The Vest'     which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient     over the chest wall. The generator rapidly inflates and deflates 'The Vest' which gently     compresses and releases the chest wall between 5 and 20 times per second. This generates     mini-coughs which are said to dislodge mucus from the bronchial walls and to facilitate its     movement up the airways. In addition 'The Vest' has been shown to reduce the viscosity of     mucus and this should further enhance mucous clearance. The technique has, for many years,     been widely used in the United States of America as an alternative to the European airway     clearance regimens of the active cycle of breathing techniques, autogenic drainage, positive     expiratory pressure and oscillating positive expiratory pressure, but 'The Vest' has only     recently been registered for use in Europe. It is important that the airway clearance regimen     of 'The Vest' be compared with the alternative airway clearance regimens widely used in     Europe.      Hypothesis: In people with cystic fibrosis 'The Vest' will lead to the expectoration of an     increased weight of sputum during treatment sessions compared with alternative airway     clearance regimens.   "
227069|NCT00818168|"     This observational study is in line with the German educational plan with the aim to     implement a tool to increase and monitor the awareness of tuberculosis screening and to     reinforce the patient eligibility for a treatment with Remicade according to the Summary of     Product Characteristics (SmPc).   "
227070|NCT00818181|"     This trial is performed to assess safety of a sublingual birch pollen extract.   "
227071|NCT00818194|"     The purpose of this study is to compare the effects of steady state tacrolimus vs.     cyclosporine on renal pharmacodynamics in healthy volunteers.   "
227072|NCT00818207|"     This study is based on the hypothesis that access to smoking cessation treatment (SCT)     reimbursement may significantly increase the number of successful quitters in a population of     smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by     improving subject adherence to treatment.   "
227053|NCT00817960|"     Experimental design overview The proposed project is a prospective experimental study design.     independent old adults(age 65 years old and older) who do not suffer from balance problems     willing to participate in the study will be tested with well-established measuring techniques     of Balance control before and 2 hours after taking of Methylphenidate (Ritalin) in the     movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract     standardized stabilogram-diffusion parameters from each of the COP data sets collected during     quiet standing. These parameters include diffusion coefficients, critical displacement,     critical time and scaling exponents for both lateral and anterior-posterior sway directions     (Collins & De Luca, 1993). For each of the conditions (before and 1 hour after the use of     Ritalin) in three task conditions single task; dual task (concentrating and identifying     specific music); and just Listening to a relaxing music. Participants will be required to     stand on the platform 10 times for 30 s. For each trial, they will be instructed to sway as     little as possible.   "
227054|NCT00817973|"     Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular     risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates     profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little     information exists about the effect of proteins.      The purpose of this study is to compare the effects of the proteins casein, whey, cod, and     gluten on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.   "
227055|NCT00817986|"     The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil     sustained release tablets taken every 12 hours compared to placebo in subjects with acute     back spasms in the lumbar region.   "
227056|NCT00817999|"     This study will measure the percentage of platelet aggregation inhibition with a loading dose     of clopidogrel (300 mg) using the VerifyNow Assay System in healthy volunteers who have drank     11 oz of grapefruit juice. It will also measure the percentage of platelet aggregation     inhibition with a maintenance dose of clopidogrel (75 mg/day) using the VerifyNow Assay     System in healthy volunteers who have drank 11 oz grapefruit juice daily.   "
227057|NCT00818012|"     This study aims to evaluate the utility of the atrial electromechanical interval and pulse     wave velocity in the prediction of recurrence of atrial fibrillation among patients who     underwent successful direct current cardioversion for atrial fibrillation.   "
227059|NCT00818038|"     The primary objective of the study was to measure the change in bladder function as measured     by Urogenital Distress Inventory (UDI)-6 compared to baseline over 6 months of Tysabri     treatment. Secondary objectives were to (i) measure change from baseline over 6 months of     Tysabri treatment in the number of urinary incontinence episodes per participant per week,     (ii) measure change from baseline over 6 months of Tysabri treatment in the number of     micturitions per participant per day, (iii) measure change in The North American Research     Committee on Multiple Sclerosis (NARCOMS) bladder/bowel subscale (PSB) scores from baseline     over 6 months of Tysabri treatment and (iv) measure change in Incontinence Impact     Questionnaire (IIQ)-7 scores from baseline over 6 months of Tysabri treatment.   "
227060|NCT00818051|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized     radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose     of radiation directly to the tumor may kill more tumor cells and cause less damage to normal     tissue. It is not yet known which radiation therapy schedule is more effective in treating     breast cancer.      PURPOSE: This randomized phase III trial is studying three different radiation therapy     schedules to compare how well they work in treating women who have undergone breast     conservation surgery and systemic therapy for early breast cancer.   "
227061|NCT00818064|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     safety and tolerability of single doses of Anti-IL-20 in healthy volunteers (HV) and patients     with rheumatoid arthritis (RA).   "
227062|NCT00818077|"     This study will look at the impact that meals have on blood glucose (sugar) levels. Subjects     will be asked to use a Continuous Glucose Monitoring System (CGM), which monitors glucose     levels continuously. Breakfast and lunch meals will be provided and must be consumed at the     International Diabetes Center.   "
227063|NCT00818090|"     To assess the efficacy and safety of the regimen in previously untreated, unresectable     invasive thymoma or thymic carcinoma   "
227064|NCT00818103|"     Compared with MS in white populations, in people of China descent multiple sclerosis (MS)is     characterized by lower prevalence, more frequent and severe involvement of the visual system     at onset and during the entire clinical course, more common occurrence of optic and spinal     involvement, relatively rapid progression and less common occurrence of a progressive course.     Data are not available for mainland China that are focused on characteristic studies of MS.     In this study, the investigators sought to explore the characteristics of MS among Chinese in     China, by conducting a study on genetics, pathogenesis, pathology, neuroimaging     characteristics, and so on. Based on these data, the investigators try to explore the     difference in neuromyelitis optical (NMO) and MS and provide clinical data for treatment     guidelines for NNO and MS.   "
227065|NCT00818116|"     The objective of this study is to evaluate postoperative visual function in patients     implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).   "
227066|NCT00818129|"     The primary objective of this study is to investigate the safety and tolerability of single     and multiple oral doses of AZD7295 in healthy male Japanese subjects. This will be done by     comparing the effect of AZD7295 to placebo. The study will aslo investigate the absorption,     distribution and disappearance of AZD7295 in the body.   "
227067|NCT00818142|"     We propose to conduct a monthly group of persons with type 1 diabetes who also withhold     insulin. Subjects will be asked to complete a 2-page survey (check-in sheet) at the beginning     of each session and a 5-page survey (Diabetes and Eating Disorders Survey) on their first     session and at their last session of their group.   "
227068|NCT00818155|"     The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine     succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and     the effects of the drug will also be evaluated.   "
227078|NCT00818285|"     Drug-related illness accounts for 5% to 23% of hospital admissions, and is now claimed to be     the sixth leading cause of mortality. Older adults are at higher risk of adverse drug-related     events, and medication-related fall injuries are the most common adverse event that could be     potentially prevented. There are 1.2 million falls per year among Canadian elderly, at a cost     of $2.4 billion in health care services, and substantial risk of loss of independence.      The overall purpose of this research program is to reduce medication-related fall injuries by     using computerized electronic prescribing and drug management systems to identify high risk     patients and provide physicians with patient-specific recommendations for modifying     psychotropic medication use to reduce this risk.   "
227079|NCT00818298|"     Ziprasidone is recommended to be dosed twice daily for the treatment of schizophrenia, based     on peripheral pharmacokinetics and a knowledge of its half life in plasma level (5-10 hours).     However, the plasma kinetics do not always mirror what occurs in the brain. Antipsychotics     with a high-affinity at D2 receptors attach for a relatively long time to their binding sites     even after plasma levels declined. Based on this observation, another antipsychotic with a     similar high-affinity at D2 receptors, ziprasidone, would also be expected to keep a     sufficiently high D2 receptor occupancy even 24 hours after the last dose.      Given >60% D2 occupancy is required to maximize chance of therapeutic efficacy, it would be     valuable to assess the D2 receptor occupancy 24 hours postdose to predict the therapeutic     effects of once-daily regimen. In this study, we will measure D2 receptor occupancy 6, 12,     and 24 hours after the last dose of ziprasidone in patients with schizophrenia.      The hypotheses are as follows: First, based on the known affinity of ziprasidone, the     dopamine D2 occupancy 24 hours after the last administered dose of 80 mg will be >60%.     Second, the difference in dopamine D2 occupancy between scan at 6 hours and 24 hours will be     less than 15%. Third, the difference in dopamine D2 occupancy between scan at 12 hours and 24     hours will be less than 10%. Fourth, ED50 24 hours post dose will be higher that those 6 and     12 hours postdose.   "
227092|NCT00824889|"     Natural Killer (NK) cells play a unique role during innate immune responses as they are able     to recognize and eliminate, without specific sensitization, tumors, microbe-infected cells as     well as allogeneic cells.In a first time, we will characterize the tissue distribution, the     phenotype and the effector functions of NK cells present in the human healthy skin.   "
227159|NCT00826085|"     This is a research study to evaluate the effects of ThermoDox in combination with therapeutic     heating of the chest wall in the treatment of recurrent regional breast cancer. The purpose     of this study is to evaluate the bioequivalence of ThermoDox and measure efficacy in     recurrent chest wall patients.   "
227080|NCT00818311|"     Photomodulation is a process which manipulates or regulates cell activity using light sources     without thermal effect. Different studies have investigated the use of non-thermal low dose     light emitting diode (LED) array for improving the appearance of photo aging damage. The     photomodulation concept includes a low energy, narrow band or coherent light with specific     pulse sequences and durations.      Preliminary investigations done by McDaniel et al. demonstrated that fibroblast activity     could be regulated using pulsing light at specific wavelenghts. Using a variety of LED light     sources, his group has demonstrated that by varying light pulses and other parameters,     procollagen synthesis could be upregulated in human skin fibroblast culture [McDaniel DH, et     al.Lasers Surg Med. 2002; 14-251]. A clinical correlation was also shown based on different     clinical trials data on around 1000 subjects, LED has shown up to 90% improvement in wrinkles     and an increase of collagen synthesis versus control with little or no side effects     associated [Weiss, RA et al. Lasers Surg Med 2005; 36(2): 85-91- Weiss, RA et al.: J Drugs     Dermatol 2004; 3(6): 605-610 - Weiss RA et al. Dermatol Surg 2005; 31(9):1999-1204 - Russel     BA et al. J Cosmet Laser Ther 2005; 7 (3-4):196-200 - Bhat J et al. Laser Med Sci 2005;     20(1):6-10]. Based on these promising clinical data, Light BioScience submitted a dossier to     the Food and Drug Administration (FDA) and obtained in January 2005 the FDA approval for its     GentleWaves® Light Emitting Diode (LED) for the non-invasive treatment of periorbital (eye     area) wrinkles and rhytids. The LED technology has been considered by FDA as non significant     risk. In Europe, the GentleWaves® Light Emitting Diode has obtained the notified body     certification for the same indication. This medical claim is associated with cosmetic     improvement of aging and sun-damaged skin, further validation the science of LED     photomodulation skin rejuvenation [Investigator's Brochure. Version 1].      This approval has been obtained with a professional LED GentleWaves® device used under a     physician's responsibility. The initial regimen of 35 seconds twice per week with at least     two days in between treatment for a total of 4 weeks duration of treatment has demonstrated     efficacy for the treatment of typical signs of photo aging and no adverse effect.      A monocentre, randomized clinical study.   "
227081|NCT00818324|"     The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic     suspension during 52 weeks in dry eye patients   "
227082|NCT00818337|"     The objective of this pilot study is to evaluate the prevalence of biological aspirin     resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness     will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women     identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then     re-tested for aspirin responsiveness.   "
227083|NCT00818350|"     Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic     bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a     similar efficacy but less toxicity.      Almost all responding patients relapse within the first year, with a median survival of 12     months. Prognosis is very poor in patients who display progressive disease after receiving     combination cisplatin-based chemotherapy.      No standard has yet been established for second-line treatment and well designed trials of     second-line chemotherapy for metastatic transitional carcinoma of the urothelium should be     given high priority.      Several drugs have been used in second line for metastatic disease with poor results.      The investigators have planned a Phase II study, open-label, single arm design to evaluate     the activity and safety of sunitinib in metastatic urothelial carcinoma, pretreated with     standard regimen (cisplatin-gemcitabine).      No previous studies have been published with sunitinib in metastatic bladder cancer.   "
227084|NCT00818363|"     This is a research study testing SABER™-Bupivacaine (an experimental pain-relieving     medication). SABER™-Bupivacaine is designed to continuously deliver bupivacaine, a common     local anesthetic, for a few days in order to treat local post-surgical pain.      The purpose of this study is to investigate safety (if there are any side effects) associated     with the use of SABER™-Bupivacaine and how well it works in reducing pain and opioid-related     side effects following shoulder surgery.   "
227085|NCT00818376|"     The presence of plaque on tooth surfaces as a predictor of chlorhexidine side effects has not     been evaluated especially because most studies utilized a previous disruption of biofilms in     all dental surfaces before the beginning of rinsing. The purpose of this study is to compare     staining and calculus formation after 0.12 percent chlorhexidine between previously     plaque-free and plaque-covered surfaces by means of an experimental gingivitis model.   "
227086|NCT00818389|"     The purpose of this study is to compare the effectiveness of lithium combined with riluzole     to riluzole combined with placebo in people with amyotrophic lateral sclerosis.   "
227087|NCT00818402|"     The principal objective is to study clinical observations, symptoms and quality of life of     non-small-cell lung cancer (NSCLC) patients undergoing specific non-operative treatment for     cancer, including chemotherapy and radiotherapy.   "
227088|NCT00818415|"     To determine the pharmacokinetic profile of the investigational product following dosing     under fed conditions.   "
227089|NCT00818428|"     Recent research reveals genetic and symptomatic overlap among children with speech sound     disorders (i.e., those who (misarticulate more sounds than would be expected for their age)     and children with dyslexia (i.e., those who struggle to learn to read). Children who have     speech sound disorders as preschoolers are at risk for the later emergence of dyslexia, a     risk that often reveals itself in the form of poor phonological awareness skills during the     preschool period. Traditional speech therapy methods focus on articulation accuracy and do     not focus on the child's more abstract knowledge of the sound system of the language. The     ultimate objective of this research program is to prevent reading disability in children who     present with speech sounds disorders. The relative effectiveness of different interventions     to help these children achieve age-appropriate phonological processing skills prior to school     entry will be investigated. It is expected that a combination of treatment approaches that     focus on speech perception skills and vocabulary knowledge will have a superior impact on     phonological awareness in comparison with a treatment approach that focuses solely on     articulation accuracy.   "
227090|NCT00818441|"     This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in     patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or     pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15     years) or have known EGFR activating mutation; or patients with HER 2 amplification or     mutation.   "
227091|NCT00818454|"     The primary goal of this trial is to compare the efficacy and safety of COMBIVENT CFC MDI     with albuterol HFA MDI, the current standard reliever medication in asthma. In the first     cross-over part of the study (Treatment Phases 1 and 2) the marketed product, COMBIVENT CFC     MDI will be used. In the second, parallel group part of the trial (Treatment Phase 3)     COMBIVENT RESPIMAT will be tested for acute bronchodilator efficacy in a blinded manner at     the clinic visits. During the third 4-week treatment phase open label COMBIVENT RESPIMAT will     be used for symptom relief as needed.   "
227093|NCT00824902|"     The primary objective is to perform a pilot trial evaluation of a novel prostate ultrasound     imaging software utilizing tissue elasticity measurements to identify tumor foci among men     who will undergo radical prostatectomy for localized prostate cancer.      As a secondary objective, investigators will compare elasticity measured tumor foci volume to     the measured volume from radical prostatectomy pathologic examination.   "
227094|NCT00824915|"     The purpose is to prospectively monitor the performance of the RV Lead Integrity Alert (LIA)     upon commercial release.   "
227095|NCT00824928|"     To provide a systemic, uniform and user-friendly tool for collection of data on prostate     cancer salvage cryotherapy in a multicenter setting. The goal is to learn more about the     short and long term efficacy and safety of this procedure. Ultimately the data analysis will     serve as a robust guidance instrument for improving upon the utilization of this procedure     for the treatment of patients with recurrent (LRD) prostate cancer.   "
227096|NCT00824941|"     About 15 to 20 percent of individuals living in the United States have chronic abdominal     pain, often of unknown origin, which is often difficult to diagnose and treat. One possible     cause of chronic abdominal pain is an inflammation of the intestines, but it is not known     whether the two are related. Furthermore, although overweight people tend to be more likely     to have increased inflammation, it is not known whether there is a connection between     increased body weight and chronic abdominal pain. This study will examine the relationship     between symptoms of chronic abdominal pain and intestinal inflammation by comparing the     medical test results of normal weight and overweight patients who have a history of chronic     abdominal pain.      This study will include 224 subjects, who must be men and women between the ages of 13 and     45. Half the subjects will be healthy participants, and half will have had chronic abdominal     pain of unknown origin for longer than 6 months. Female participants must take a urine     pregnancy test before starting the study, and will not be allowed to participate if the test     is positive. During the study, patients will visit the NIH Clinical Center on two occasions     for testing.      On the first visit, patients will provide a medical history, including information about     current medications or natural remedies and tobacco and alcohol use, and will also fill out     questionnaires to provide information about symptoms, current levels of gastrointestinal     pain, and general quality of life. The study researchers will conduct a physical examination,     measure patients height and weight, and draw blood for testing.      Patients will be asked to not eat or drink anything for 8 hours before the second visit, and     will be asked to bring a bathing suit and a swim cap to the Clinical Center. On the day of     the visit, patients will fill out questionnaires to provide information about symptoms,     current levels of gastrointestinal pain, and general quality of life. Patients will also     provide a blood sample for testing. Researchers will measure patients blood pressure and     heart rate, height, weight, waist/hip circumference, and intra-abdominal measurement.     Patients will also be asked to put on the bathing suit and swim cap to have their body fat     measured using a machine called the BOD POD. To test the gastrointestinal system, patients     will then be asked to drink a sugar-based test solution, and researchers will collect all     voided urine for the next 5 to 6 hours. (Patients may drink water during this time.)      On either Day 1 or Day 2 of the study, patients will sip, swish and spit an additional sweet     taste solution. Patients will sip, swish, and spit different concentrations of this sweet     taste solution, for a total of 25 tastings of this solution. Subjects will then complete     questionnaires about their sweetness preferences related to these 25 tastings.   "
227097|NCT00824954|"     Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study     addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy   "
227098|NCT00824967|"     Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in     institutions for the elderly.      Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in     older people with a diagnosis of dementia.   "
227099|NCT00824980|"     The major objective of this study is to evaluate the therapeutic effect of a topical     treatment simultaneously inhibiting Dipeptidyl Peptidase IV and Aminopeptidase N (IMTM     #IP10.C8) in patients with mild to moderate psoriasis of the skin   "
227108|NCT00825097|"     Spastic equinovarus foot (SEF) is a major cause of disability in stroke patients. Treatments     may include physical therapy, orthosis, botulinum toxin (BTX) injections and selective     neurotomy.      Several RCT placebo-controlled studies have demonstrated improvement in spasticity, in pain     and in active ankle dorsiflexion after BTX injections.      Unfortunately, BTX is an expensive treatment and its effects last about three months.      Selective neurotomy consists in a partial section of the motor nerve innervating spastic     muscles responsible for the SEF, leading to a permanent treatment of the SEF.      Until now, neurotomy has only been assessed by observational case-report studies and has     never been submitted to a RCT.      The aim of our study is to evaluate the benefits of selective tibial neurotomy in case of SEF     according to the 3 domains of the ICF, by comparing it with BTX injections, among a     prospective, randomized, controlled single blind study: it would allow to promote a permanent     and cost-effective treatment in case of SEF.   "
227100|NCT00824993|"     The goal of this clinical research study is to see if ibandronate can help to slow the rate     of bone loss that may occur in patients who have received a bone marrow transplant for blood     cancer.      This study plans to address the following hypotheses:        1. The addition of Ibandronate initiated immediately after the transplantation will prevent          bone loss in patients undergoing allogenic bone marrow transplantation (BMT) with          underlying hematologic malignancies or hematologic disorders.        2. BMT patients who require prolonged steroid and other immunosuppressive treatment for          Graft versus Host Diseases(GVHD) have a higher rate of bone loss, which can be prevented          or attenuated by Ibandronate.      Specific objectives to test these hypotheses are:        1. Primary Objective:           1. To prospectively compare the bone mineral density changes of lumbar spine, femoral          neck and total hip between patients randomly assigned to ibandronate and control group          over 12 months post bone marrow transplantation at the University of Texas MD Anderson          Cancer Center.        2. Secondary Objectives:             1. To measure and compare the accumulated level of steroid used in both treatment and               control groups.             2. To collect and compare the level of serum C-terminal telopeptide (CTX) in both               treatment and control groups to monitor the bone turnover rate for the duration of               the study.             3. To conduct a cost-effectiveness analysis of participating patients for both               outcomes on bone mineral density (measured data) and skeletal-related events               (modeled data).             4. To record incidence of bone fractures and the graft rate in both treatment and               control groups.   "
227101|NCT00825006|"     To investigate the hemodynamic, inter and intraventricular desynchrony effects of anodal     stimulation and triple site pacing compared with the usual dual site pacing by     echocardiography and Tissue Doppler Imaging.   "
227102|NCT00825019|"     Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression     rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment     of patients with a recurrent major depressive episode (MDD).      Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to     placebo and to assess plasma concentrations of the active metabolite.   "
227172|NCT00826254|"     Part 1) Bone health after transplantation - possible influence of vitamin K      Part 2) Fat metabolism and endocrine parameters - possible predictors for developement of     overweight after transplantation   "
227103|NCT00825032|"     Recent guidelines on pulmonary rehabilitation (PR) recommend upper extremity exercise     training (UEET) in patients with chronic obstructive pulmonary disease (COPD).      The theory supporting the inclusion of upper extremity exercise training in the pulmonary     rehabilitation for these patients, is based on the profound understanding of the activity of     the accessory respiratory muscles, which are competitively involved in both the support of     the upper extremities during activities and the ventilation. However, a systematic review of     the literature carried out by our staff reveals that the clinical trials carried out up to     now to verify the effectiveness of UEET are of poor methodological quality and the     investigators cannot corroborate the recommendation recently made on the basis of the results     of the investigators' review.      Therefore the investigators began this randomized, parallel groups, controlled clinical trial     with the purpose of determining the short-term effect of unsupported UEET on the performance     of the upper extremities and on symptoms perceived during activities by patients with COPD.   "
227104|NCT00825045|"     This study will provide information regarding dopamine D2/D3 occupancy related with     clinical/adverse effects in older people with schizophrenia and schizoaffective disorder. The     results of this study will also show an appropriate dose range in order to evade undesirable     adverse effects while deriving therapeutic effects, which will directly serve to guide     physicians in clinical practice. Furthermore, the findings of this study will elucidate     mechanisms underlying older people's increased sensitivity to antipsychotic drugs. In     addition, the contribution of D2 and D3 in mediating antipsychotic response will be     contrasted, using 2 radiotracers, which has never been tested in an older population.      The hypotheses are as follows: First, clinical response (i.e., a ≥ 20% decrease in the Brief     Psychiatric Rating Scale total score) will be achieved in older patients with occupancy that     is lower than the threshold of 60% in historical young controls. Second, prolactin elevation     and EPS will be detected in older patients with occupancies that are lower than the     thresholds of 72 and 78% reported in historical young controls. Third, dopamine D2 receptor     occupancy will be inversely correlated with subjective well-beings. Fourth, the binding     potential and receptor occupancy will be at least 20% lower with [11C]-(+)-PHNO than with     [11C]-raclopride in the caudate/putamen. Fifth, the binding of [11C]-(+)-PHNO in the globus     pallidus will be higher than that of [11C]-raclopride.   "
227105|NCT00825058|"     Primary objective :        -  To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of          SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent          major depressive episode.      Secondary objectives:        -  To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess          plasma concentrations of the active metabolite.   "
227106|NCT00825071|"     The investigators want to test the efficacy of these anesthetic antiemetic measures     collectively with or without ondansetron or dexamethasone, in the prevention of postoperative     nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy.   "
227107|NCT00825084|"     This study is to characterize the pharmacokinetics of single and multiple oral doses of     Dimebon in Japanese healthy subjects. This study is also to evaluate the safety and     tolerability of single and multiple oral doses of Dimebon in Japanese healthy subjects. The     secondary objective of this study is to compare the pharmacokinetics, safety and tolerability     of single and multiple oral doses of Dimebon in Japanese and Western healthy subjects.   "
227109|NCT00825110|"     the principal research objective is to form a database of tissue samples from patients with     colorectal (bowel) cancer. The tissue samples that will be used for this research will have     already been taken for diagnostic or therapeutic reasons. We will also be asking for consent     for a research blood sample. The database will be used to improve our understanding of the     molecular genetics and gene expression patterns in colorectal cancer.   "
227110|NCT00825123|"     The purpose of this project is to determine the effects of slowing heart rate upon both     central and peripheral blood pressures using Ivabradine. The effects of Ivabradine will be     compared to Metoprolol and placebo.      Participants will attend the hospital for 3 visits where they will be randomised to receive     either Ivabradine, Metoprolol and placebo on each visit. Non-invasive measures of blood     pressure will be recorded before and after consuming the study drug.   "
227111|NCT00825136|"     Internet plays a more and more important role in many applications of healthcare. Many     researches on the integrations of internet and mental health care have been proposed in     recent years. This project aims at the development of an online treatment system which     combines the biofeedback therapy and the web technologies to treat the patients suffering     from panic disorder with partial response to medications. This project also evaluates the     efficacy of a new- designed wireless temperature biofeedback ring.   "
227112|NCT00825149|"     This open-label, randomized, phase Ib study will assess the safety and efficacy of     obinutuzumab given in combination with FC (fludarabine and cyclophosphamide) or CHOP     (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction     chemotherapy in participants with Cluster of Differentiation (CD) 20+ B-cell Follicular     Lymphoma (FL). Participants with complete response or partial response after induction     therapy may receive maintenance therapy every 3 months for 2 years or until disease     progression, whichever comes first. All participants in the induction period of the study     will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab +     chemotherapy, and will be followed for at least 2 years, unless they are being treated in     maintenance or discontinue from the study prior to this time point. Participants who     complete/discontinue maintenance therapy will also be followed for a period of 2 years after     receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.   "
227113|NCT00825162|"     A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of     CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18     Years   "
227114|NCT00825175|"     This study determines the effect of orthotic use in combination with treadmill training on     the development of gross motor skills and walking onset in infants with Down syndrome.   "
227128|NCT00825682|"     Oncologic patients often report increased fatigue during and after radiation therapy.     Reflexology treatment has been demonstrated to alleviate symptoms of fatigue, nausea, and     anxiety in oncologic patients treated with chemotherapy. The aim of the study is to evaluate     the effect of reflexology on fatigue, quality of life, and quality of sleep of breast cancer     patients during and after radiation therapy.   "
227115|NCT00825188|"     Obesity and hypertension are independent risks for congestive heart failure (CHF) and chronic     kidney disease. In obesity induced hypertension, the most common cause of human essential     hypertension, the potential importance of mineralocorticoid receptor blockade has not been     widely investigated. We propose to test the hypothesis that eplerenone reduces metabolic     demand, improves cardiac function and attenuates glomerular hyperfiltration and     microalbuminuria in obese patients. Our specific aims are to assess changes in basal     metabolic rate, cardiac and renal function in obese hypertensive subjects treated with     eplerenone compared to amlodipine.   "
227116|NCT00825201|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle     formulation directly into the abdomen may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal     paclitaxel albumin-stabilized nanoparticle formulation in treating patients with advanced     cancer of the peritoneal cavity.   "
227117|NCT00825214|"     Mosquito bites commonly result in redness, swelling and itching. This study will determine if     a device that emits a small piezo-electrical impulse can provide relief from these symptoms.     Volunteers entering the study will have a mosquito bite on one forearm. Redness and     irritation will be recorded periodically for 24 hours. Comparing data from subjects     randomised to the treatment or a placebo device will be analysed to determine effectiveness     of the product. We will also ask the subjects their view on how easy the product is to use     and clarity of instructions provided.   "
227118|NCT00825552|"     The purpose of this study is to investigate whether Risperidone is effective in children and     adolescents with severe mood dysregulation.   "
227119|NCT00825565|"     The purpose of this study is to determine how safe and effective allantoin 3% cream     (Alwextin) is in improving the healing of recurrent skin lesions and reducing overall     blistering in people with epidermolysis bullosa (EB). Allantoin 3% cream is applied topically     to the entire body once daily.   "
227120|NCT00825578|"     Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other     than the upper lobes, as determined by high resolution computed tomography (HRCT), could have     a positive response to valve treatment.   "
227121|NCT00825591|"     Background: Optic Nerve Hypoplasia (ONH) is a leading cause of blindness in children. For     unclear reasons, the incidence of ONH is increasing, with ONH affecting about 1 in 10,000     live-born infants. In addition to visual deficits, ONH is associated with varying degrees of     hypopituitarism, developmental delay, brain malformations and obesity. Although genetic     mutations have been rarely observed to result in ONH, the causes of ONH are largely not     known. In limited anatomical observations, the suprachiasmatic nuclei (SCN) located in the     anterior hypothalamus, which generate circadian rhythms, have been observed to be abnormal in     children with ONH. Thus, children with ONH may have biological clock dysfunction.      In collaborative studies with Dr. Mark Borchert of Childrens Hospital Los Angeles (CHLA), we     have recently discovered that one-half of children with ONH have grossly abnormal sleep-wake     patterns, as assessed by actigraphy. Although not known for children with ONH, abnormal     sleep-wake patterns have been observed to be associated with neurocognitive impairment and     obesity. We also observe that nocturnal melatonin administration can improve abnormal     sleep-wake cycles in these children, raising the possibility that it will be possible to     treat abnormal rhythmicity in children with ONH.   "
227122|NCT00825604|"     The purpose of this study is to, in patients with stable angina pectoris, assess the     additional benefit of PCI on top of optimized medical treatment, physical training and     smoking cessation with regard to quality of life, achievement of target of treatment and     clinical events such as death, acute myocardial infarction, stroke and revascularization.   "
227123|NCT00825617|"     Several studies have demonstrated that Turner Syndrome patients have elevated liver enzymes     readily suppressible by a short course of HRT. We wanted to estimated quantitative liver     functions in a young group of Turner syndrome patients compared to a healthy control group.   "
227138|NCT00825812|"     The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex     compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects     for registration purposes in China.   "
227259|NCT00827385|"     The purpose of this study is to prospectively determine the association between incidence of     neurological morbidity and minimum fractional blood pressure reached during laminectomy     procedures under general anesthesia in hypertensive and normotensive subjects 40 years old     and older.   "
227124|NCT00825630|"     Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test     (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and     after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in     each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath     Test). The aim of the trial is to observe the effect of different PPIs on the breath test and     choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a     minimal effect on the UBT while using selected PPIs.   "
227125|NCT00825643|"     This study is conducted in Europe, North America and Asia. The aim of this observational     study is to evaluate the safety and effectiveness while using Levemir® once daily in     combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal     clinical practice.      Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and     reported together in the final study report for this study.   "
227126|NCT00825656|"     The purpose of this study is to demonstrate the equivalence of two homeopathic capsaicin     containing nasal sprays (Sinol-M™ and Sinol) in patients with nasal congestion due to     allergic rhinitis.   "
227127|NCT00825669|"     Hepatectomy is still the treatment of choice for hepatocellular carcinoma. Part of the     patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might lead to     upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life     of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There     is no standard treatment for PVTT yet. We aim to compare the effects of TACE and TACE plus     laser ablation for treating patients with PVTT.   "
249240|NCT01118390|"     Studying the results of treatment of dilated vessels of the lower limbs with laser, and     compare them to those obtained with sclerotherapy.   "
227129|NCT00825695|"     The purpose of the study is to learn whether or not cocoa has a beneficial effect on blood     flow to the brain in older subjects with diabetes mellitus or hypertension (high blood     pressure). We hypothesize that cocoa, which contains flavanols (a type of polyphenol), may     help to promote blood flow to the brain in older people with diabetes or hypertension.   "
227130|NCT00825708|"     The aim of the study is to evaluate the immediate effect of rTMS on attention in adults     diagnosed with ADHD. the design is a double blind sham controlled crossover study.   "
227131|NCT00825721|"     This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution     in patients with loss of visual function due to age-related nuclear cataract   "
227132|NCT00825734|"     In this study, patients with metastatic HER2-negative breast cancer will receive treatment     with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The     Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib     and ixabepilone that may be used in combination for first- or second-line treatment of MBC.     The MTDs identified in the Phase I portion of the study will be used in the Phase II portion     which will evaluate the efficacy and safety of the combination of sorafenib and ixabepilone     in patients who have received at least one prior chemotherapy treatment in either the     adjuvant or neoadjuvant setting or following one prior MBC chemotherapy in MBC patients who     had not received prior adjuvant or neoadjuvant breast cancer chemotherapy. This will be one     of the initial trials investigating the use of this treatment combination for MBC.      This trial will be conducted under the leadership of the Sarah Cannon Research Institute     (SCRI) Oncology Research Consortium, a community-based, multi-center, clinical trial     organization.   "
227133|NCT00825747|"     Senile cataract is managed by cataract extraction and intra-ocular lens (IOL) implantation.     The purpose of this study is to evaluate the safety and efficacy of the SeeLens AF, an     acrylic hydrophilic aspheric IOL. This lens was designed to reduce vision aberrations and     secondary cataract formation rate.      Preoperative evaluation: Best corrected visual acuity, refraction, comprehensive slit lamp     examination and biometry.      Surgical procedure: Cataract surgery using a clear corneal incision (1.8mm to2.4mm),     phacoemulsification and implantation of the SeeLens AF to the capsular bag. IOL implantation     parameters will be evaluated by the surgeon.      Postoperative follow up: Best corrected visual acuity, uncorrected visual acuity, refraction     and comprehensive slit lamp examinations up to 3 months after surgery.   "
227134|NCT00825760|"     Some leg ulcers do not seem to respond that well to the standard treatments that we currently     use. One reason for this may be that there are high levels of bacteria in the ulcer which may     be slowing down the rate of healing. Because we need to be careful about when we use     antibiotics, this study will look at another way of killing bacteria in the ulcer. This new     method involves putting a special gel on the ulcer and then shining a particular type of     light (visible red light) onto the ulcer for a short period of time.      In the first part of the study, a single treatment with the gel and light will be     investigated. The second part of the study will compare whether or not using the treatment     once a week for 12 weeks is better than placebo.      Across the UK 57 people with chronic leg ulcers will be asked to take part in this study (9     in part 1 and 48 in part 2). Up to 10 sites will be involved including Cardiff University and     hospitals in Bradford, Harrogate, Dundee, Hull, Plymouth and the Wirral.      The research is funded by Photopharmica Ltd.   "
227135|NCT00825773|"     E.V.O.L.U.T.I.O.N.: A Randomized Study to Evaluate Safety and Efficacy of the Excel Sirolimus     Eluting Stent with a Biodegradable Polymer Versus Sirolimus Eluting Stent with a     Non-Biodegradable Polymer in the Treatment of Patients with de novo Coronary Artery Lesions.   "
227136|NCT00825786|"     This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90     seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a     quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local     anesthetics.   "
227137|NCT00825799|"     The goal of the study is to validate a biomarker assay for unipolar depression based on serum     proteins involved in inflammation, metabolism, and stress response. The study will compare     patients with a current major depressive episode to individuals with no history of     depression. The hypothesis is that the assay can serve as a diagnostic tool that would be     more objective than standard diagnostic questionnaires.   "
227139|NCT00825825|"     Escitalopram (Lexapro) and citalopram (Celexa) are similar selective serotonin reuptake     inhibitors that alter blood flow to the amygdala and other brain structures involved in     regulating mood. Escitalopram consists of S-citalopram while citalopram contains both     S-citalopram and R-citalopram (racemic citalopram). There is evidence that R-citalopram may     block the effects of S-citalopram. The hypothesis being tested is that because of the     antagonist effect of R-citalopram, S-citalopram will have a greater effect on the mood     circuit than racemic citalopram when equal doses of S-citalopram are administered. The study     design consists of a two week medication period followed by blood oxygen level dependent     (BOLD) functional magnetic resonance imaging (fMRI) while viewing affective visual stimuli.   "
227140|NCT00825838|"     The purpose of this study is to test the safety and effectiveness of a purified extract of     CH-19 Sweet, containing capsinoids.   "
227141|NCT00825851|"     The aim was to determine the wound healing capacity in healthy never smokers and smokers who     continue to smoke, or quit smoking using transdermal nicotine patch versus placebo patch.   "
227142|NCT00825864|"     To study the effect of Diclofenac drops or Dexamethasone drops on combined surgery of     trabeculectomy and cataract surgery.   "
227158|NCT00826072|"     Acute lung injury is a common complication of cardiac surgery with cardiopulmonary bypass,     and it is significantly related to prolonged postoperative recovery, hospital stays and     medical cost. Currently available predictors of acute lung injury after cardiac surgery are     still limited within clinical data. Several genetic polymorphism of inflammatory mediators     have been reported to be associated with severity of sepsis and ARDS, but the association of     these inflammatory polymorphism and acute lung injury after cardiac surgery has never been     reported. This study is performed to investigate the association of genetic polymorphisms     including TNF -308A/G, IL-10 -1082A/G and IL-6 -572C/G and postoperative lung injury.   "
228512|NCT00846989|"     This purpose of this study is to access the efficacy, tolerability and safety of RKI983     (0.05% and 0.10%) ophthalmic solution bid versus once daily latanoprost 0.005%, in patients     with POAG or ocular hypertension.   "
227143|NCT00825877|"     The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) trial is a     multicenter clinical trial conducted to assess the effects of long-term antiviral drug     therapy on the progression of liver disease in patients who have advanced chronic hepatitis C     and have not responded to prior therapies. Chronic hepatitis C is a long-lasting viral     infection affecting the liver that may lead to permanent liver damage and cirrhosis     (replacement of healthy liver cells by scar tissue). If left untreated, a proportion of     patients with chronic hepatitis C will be at risk for complications of liver disease. The     drug therapy in the HALT-C trial was designed to clear the hepatitis C virus from the patient     s system in order to prevent or mitigate these potential complications. The purpose of this     research is to determine if patients with chronic hepatitis C who experienced clearance of     hepatitis C virus (known as a sustained virologic response, or SVR) during the HALT-C trial     have developed any complications of their liver disease.      This study will include 180 subjects who participated in the initial phase of the HALT-C     trial and experienced an SVR. The participants will visit the National Institutes of Health     for an in-person study visit.      During the visit, patients will have blood drawn for lab tests to monitor the progress of     their liver disease, and may be asked to undergo an ultrasound examination of the liver to     detect any abnormalities that may be attributed to liver cancer. Patients will also answer     questions about their medical history particularly any outcomes or events related to their     hepatitis C that have occurred since the HALT-C trial and may be asked to sign a release of     information to allow researchers to obtain medical records from other clinics or physicians     where they have received treatment.   "
227144|NCT00825890|"     To investigate of high cup/disc ratio in children.   "
227145|NCT00825903|"     Exercise has been shown to have extensive health benefits both in normally functioning adults     as well as in adults with asthma. A program of regular aquatic exercise may have unique     benefits in the asthmatic population because of the known aerobic capacity development     typical of such programs, combined with the unique value of immersion-produced improvements     in respiratory endurance and cardiac output. The purpose of this study is to explore the     effects of a 12 week long aquatic endurance training program on several physiological and     psychological parameters related to coronary heart disease and type II diabetes in an     asthmatic population.   "
227146|NCT00825916|"     The purpose of this study was to determine the safety of AZX100 Drug Product and to determine     whether it was effective in preventing or reducing re-growth of surgically removed keloid     scars.   "
227147|NCT00825929|"     Due to the potential for pregnancy-induced changes in the pharmacokinetics of medication, one     cannot assume that the currently licensed doses of the medication to be tested under this     protocol lead to adequate exposure in an HIV-infected pregnant woman. For the agents under     study no or limited pharmacokinetic data during pregnancy are available. As the changes in     pharmacokinetics during pregnancy are most prominent in the third trimester a pharmacokinetic     curve will be recorded in the third trimester after attaining steady state.   "
227148|NCT00825942|"     To determine the safety and initial efficacy of C-KAD ophthalmic solution in patients with     asteroid hyalosis   "
227149|NCT00825955|"     The purpose of this study is to determine if Brivanib is an effective treatment for liver     cancer in patients who have failed or could not take Sorafenib   "
227150|NCT00825968|"     The purpose of the database is to complete outcomes research of electrophysiological     procedures.   "
227151|NCT00825981|"     Patients undergoing elective coronary artery bypass graft surgery (CABG) are treated with     platelet inhibitors to reduce myocardial infarction and mortality.However, this can increase     perioperative bleeding. A retrospective analysis of the data in our institution has revealed     a significant increase in transfusion requirements after elective CABG since 5 years. The aim     of our study is to observe if this increase in transfusion requirements is due to platelet     inhibitors or due to other coagulation abnormalities resulting from other anticoagulants.   "
227152|NCT00825994|"     The purpose of this study is to determine if an eight-week intervention with omega-3 fatty     acids significantly reduces depressive symptoms in symptomatic peri- and postmenopausal     women. We hypothesize that an eight-week trial with omega-3 fatty acids promotes significant     improvement in depression symptoms in peri- and postmenopausal women.   "
227153|NCT00826007|"     The purpose of the study is to review incidences of mild, moderate, and severe hypoglycemia     in preoperative care units, operating rooms, and postanesthesia care units and analyze     associated conditions and treatment.   "
227154|NCT00826020|"     The purpose of this study is to determine if established parenteral nutrition (PN) associated     liver disease can be reversed or its progression halted by using a parenteral fat emulsion     prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and     bilirubin.   "
227209|NCT00826735|"     The purpose of this study was to evaluate the effect of guided imagery on the third stage of     labor. Blood loss from hemorrhage during childbirth, most commonly due to uterine atony, is     one of the leading causes of maternal mortality in the United States and the leading cause of     maternal death worldwide. The hypothesis was that the use of physiologic guided imagery would     reduce the amount of bleeding during the third stage of labor.   "
227155|NCT00826033|"     L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography     (PET). The investigators evaluated the value of 18F-FMT PET for the assessment of therapy     response in patients with lung cancer as compared with that of     2-[18F]-fluoro-2-deoxy-D-glucose (18F-FDG) PET.      The patients with lung cancer underwent PET studies with 18F-FDG and 18F-FMT before and after     radio-/chemotherapy. The investigators used the ratio of the SUVmax of the mediastinal (N2)     lymph node to the SUVmax of the primary tumor (N/P ratio ). All patients were divided into     two groups of N/P ratio<1 and N/P ratio≥1, and the survival time was estimated by     Kaplan-Meier method.   "
227156|NCT00826046|"     This protocol allows for the treatment of patients, male and female, between the ages of 18     years and 70 years. Patients must have failed to respond to steroid treatment for Grade C-D     acute GVHD.   "
227157|NCT00826059|"     The primary objective of the study is to assess the safety and effectiveness of SPG     stimulation with the ISS in patients with an acute ischemic stroke in the anterior     circulation initiated within 24 hours from stroke onset.   "
227160|NCT00826098|"     The purpose of this clinical study is to evaluate the effect of platelet rich plasma (PRP), a     derivative of a patient's whole blood, on short-term patient outcomes following total knee     replacement (TKR). The hypothesis is that change in short-term hemoglobin (Hgb) levels is     less dramatic in patients who undergo TKR with the addition of PRP when compared to patients     who undergo TKR without PRP.   "
227161|NCT00826111|"     The study examined the effects of adding the sleep aid eszopiclone to Lexapro on mood and     levels of the neurotransmitters glutamate, glutamine, and GABA in women with depression,     anxiety, and insomnia. Specifically, the objective was to determine the role of glutamate,     glutamine, and GABA in mediating the response the to the combined treatment. The hypothesis     was that levels of glutamine and glutamate will be increased in women receiving eszopiclone     compared to those receiving placebo. The antidepressant effect of the medication combination     and its effect on sleep status was also assessed.   "
227162|NCT00826124|"     Epidural steroid injections (ESI) are the most frequently performed procedures in pain     clinics. When performing ESI, there is no consensus about how to best select candidates for     this intervention, and which level(s) to inject. Some experts advocate basing the injection     level on MRI findings, whereas others recommend clinical symptoms. In order to determine     whether MRI is necessary before referring patients with chronic LBP radiating into the leg(s)     for pain management interventions, we will perform a randomized comparative study involving     131 patients with chronic low back and leg pain who are clinically candidates for epidural     steroid injections into two groups. Group I will receive two ESI based solely on historical     and physical exam (PE) findings. Group II will receive treatment only after MRI is reviewed.      The investigators' hypothesis is that MRI will not have a significant effect on treatment     outcome, and will have minimal impact on patient care.   "
227163|NCT00826137|"     Prospective randomized double-blind study on the effect of prebiotics (inulin and     fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.   "
227164|NCT00826150|"     This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and     preliminary efficacy of DTA-H19 administered intraperitoneally (IP) in subjects with advanced     stage ovarian cancer, or primary peritoneal carcinoma   "
227165|NCT00826163|"     We hypothesize that ongoing and more severe airway inflammation in COPD may result from the     impairment in activation of innate immune response   "
227166|NCT00826176|"     The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in     Chinese and Caucasian subjects for registration purposes in China.   "
227167|NCT00826189|"     The investigators had conducted an initial double-blind, placebo-controlled clinical trial     (NCT00318695) to study the effects of probiotic supplementation from birth to 6 months of age     in the incidence of atopic diseases at 2 years old. This is then further investigated up to 5     years of age in a follow-up study NCT00365469 to assess the longer term beneficial effects.      This current study intends to follow-up for another 2 years until 7 years of age as this is     critical in the evaluation of respiratory allergies in the form of clinical asthma and     allergic rhinitis.   "
227168|NCT00826202|"     The purpose of the study is to determine the safety and efficacy of D-serine as an early     intervention treatment for the schizophrenia prodrome condition. This study is a     placebo-controlled trial of D-serine in the symptomatic treatment of patients with the     schizophrenia prodrome. Seventy two subjects meeting criteria for the schizophrenia prodrome     will be included in this study, 24 at each site (Yale, Nathan Kline Institute and Zucker     Hillside Hospital). The primary outcome measures will include symptom and neuropsychological     measures. The duration of this study is two and a half years.      This research with D-serine holds out the prospect of direct benefit for the patient's     current symptoms. Subjects may also benefit from the close monitoring of their symptoms, so     that, if schizophrenic psychosis does occur, the psychosis will be recognized and treatment     may begin with minimal delay. This study also could be of benefit by suggesting a promising     lead in early intervention in the schizophrenic prodrome.      Overall Design Summary. We propose for prodromal patients to be randomized to D-serine vs     placebo for 16 weeks. To insure that all subjects have the opportunity to receive D-serine,     there will be an optional 16 week cross-over trial on the alternate study medication. No     subject will be on D-serine for longer than 16 weeks. Admission criteria, Assessment     Procedures, and Study Design will be the same across all sites. The procedures and timeline     are shown in Table 1. The procedures and timeline are the same for the initial randomized 16     week trial and the optional cross-over trial on the alternate study medication. If patient's     opt for the 16 week treatment on the alternate medication, we will use their assessments from     end of initial treatment as baseline for 16 week treatment on alternate medication. Subjects     will be seen for two preliminary visits, then once in treatment, subjects will be seen weekly     for the first 5 visits then biweekly thereafter. A safety blood and urine collection will be     done on day 3 (3 days after the start of study medication). Vital signs and weight, blood     draw and urine collection for safety measures, urine pregnancy test and urine for toxicology     will be repeated throughout treatment. Adverse effects ratings and symptom assessments will     be repeated at each visit. Neuropsychological assessment and optional Biomarker study     visual, auditory and ERPs tasks will be administered during one of the two preliminary visits     then again at study endpoint. Any patients who convert to frank psychosis will be     referred/offered immediate treatment.   "
227169|NCT00826215|"     Objective: The primary objective of this study is to evaluate the long-term efficacy of     electroacupuncture for chronic neck pain. The secondary objective is to document any possible     side effects of acupuncture.      Design and Subjects: Prospective, randomised controlled trial comparing the outcomes of     treatment and placebo interventions. Subjects are 200 adult patients with chronic mechanical     neck pain.      Setting: Outpatient clinics.      Interventions: Patients will be randomly allocated to one of the two groups receiving either:     electroacupuncture (real treatment) or placebo (sham laser acupuncture). Each treatment will     last for 45 minutes. Each patient will receive a total of nine treatments (three times per     week for three weeks).      Main outcome measures:      Primary outcome measures: Neck pain disability index (Northwick Park Neck Pain     Questionnaire).      Secondary outcome measures: Maximum pain related to motion on visual analogue scale. Quality     of life (SF-36). Use of medication. Sick leave because of neck pain. Treatment-related     adverse effects, such as pain, skin irritation, bleeding and dizziness, will also be     assessed.      Assessments will be made before treatment, one month, three months and six months after the     treatment course. The credibility of placebo treatment will also be assessed.      Expected results: We expect that patients in the treatment group will have significant     improvements on primary and secondary outcome measures, when compared with patients in the     inert placebo group.      Conclusion: This study will provide credible evidence regarding whether electroacupuncture is     effective in reducing chronic neck pain. Patients, healthcare professionals, and government     policy makers can make use of this information to improve clinical outcomes and reduce costs   "
227170|NCT00826228|"     Individuals with spinal cord injury sustain significant loss of bone mass in their lower     extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two     interventions that build bone, to increase bone mass in this population.   "
227171|NCT00826241|"     The goal of this clinical research study is to learn if lapatinib when given in combination     with temozolomide can help to control ependymoma that has come back after treatment. The     safety of this combination will also be studied.   "
227173|NCT00826267|"     An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a     single agent versus lapatinib versus trastuzumab in patients with HER2-positive     treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be     obtained on the safety profile and pharmacokinetics of BIBW 2992.   "
227174|NCT00826280|"     Observe whether the administration of caffeine prior to regadenoson will affect the     interpretation of test results in subjects with coronary artery disease (CAD) undergoing     SPECT MPI   "
227175|NCT00826293|"     Application of a belt for stabilization while exercising accelerate and optimize recovery in     patients diagnosed with shoulder impingement syndrome.   "
227176|NCT00826306|"     The purpose of this study is to compare the effect of video-based patient education with     written instruction on subjects' adherence to sunscreen application.   "
227177|NCT00826319|"     This study will follow 2500 prevalent Chronic Kidney Disease (CKD) patients with Glomerular     Filtration Rate (GFR) from 15-45 ml/min for 30 months with serial measurements every 6 months     and subsequent annual chart review up to 60 months. This observational study will analyze the     demographics, clinical status, medications and blood and urine samples of these patients and     study the conventional biochemical, hormonal and metabolic parameters assessing which     underlying biomarkers reflect the processes involved with disease progression.   "
227178|NCT00826332|"     Embryo transfer is the last step in the IVF process. it is now recognized that this step     should be done carefully and that it affects success rates. in recent years, sonographic     guidance appears to increase success rates.   "
227179|NCT00826345|"     This preliminary study will investigate the use of Acupuncture and Moxibustion (Acu/Moxa) for     distal symmetric peripheral neuropathy (DSP) associated with HIV applying traditional Chinese     medicine (TCM) evaluations conducted by a diagnostic acupuncturist. The investigators will     evaluate the role of Acu/Moxa in reducing the symptoms of DSP related to HIV/AIDS and     treatment side effects. The effects of symptom reduction on quality of life will also be     examined. This application will establish a proof of principle for the role of Acu/Moxa in     the treatment of DSP and provide data that will serve as a foundation for establishing a     future larger clinical trial.   "
227180|NCT00826358|"     The purpose of this study is to evaluate the safety and compare the pharmacokinetic     parameters from the fixed dose combination ABT-143 relative to that from the     co-administration of the two monotherapies.   "
227181|NCT00826371|"     The purpose of the study is to provide efficacy and safety data for monthly ranibizumab 0.5     mg intravitreal injections in Chinese patients with subfoveal choroidal neovascularization     (CNV) secondary to age-related macular degeneration (AMD). The study results will support the     regulatory submission in China to make ranibizumab available for clinical use.   "
227182|NCT00826384|"     According to radiology imaging, the patients of HCC are divided into two groups(hypovascular     tumor group and moderately vascular tumor group). Every group is divided into TACE therapy     with balloon catheter subgroup and regular TACE therapy subgroup. Patients take the TACE     therapy each 45 days, and have MRI diffusion examine or CT one week before next therapy. All     objects are observed until the end event happening or in the group for 6 months.   "
227205|NCT00826683|"     Bone-marrow-derived progenitor cells (EPCS) play an important role in neovascularization and     tumor growth. In lung cancer, angiogenesis is an important event in mechanisms of tumor     proliferation and metastasis. Recent evidences suggest that EPCS can be recruited and     differentiate in mature endothelial cells to form new blood vessels. The role of EPCs in     NSCLC is unclear. In contrast, angiogenic drugs are proposed combined to systemic     chemotherapy in NSCLC. The aim of this study is to identify EPCs in peripheral blood from     patients with NSCLC, by comparison to Chronic Pulmonary Obstructive Disease (COPD), an     inflammatory disease.   "
227206|NCT00826696|"     This retrospective review will will attempt to determine whether our data show a significant     difference in number of deliveries of women with pre-eclampsia compared to deliveries without     pre-eclampsia during certain months of the year.   "
227183|NCT00826397|"     This is a randomized, controlled, pilot study to determine the safety and efficacy of     acupuncture as an adjunct to pharmacological treatment compared to pharmacological     intervention alone for the treatment of musculoskeletal pain related to aromatase inhibitors     (AI) in postmenopausal breast cancer patients. Twenty participants (20 in each arm) will be     enrolled at the Breast Oncology clinic at Columbia University Medical Center (CUMC). Patients     in the treatment arm will receive acupuncture administered twice weekly for six weeks and     will be allowed to take pain medication as necessary. The control patients will initially     receive pain medication alone, then will cross-over to the acupuncture arm after six weeks.     The investigators hypothesize that acupuncture will reduce AI induced joint symptoms.      The study will enroll a total of 40 patients, half of whom will be randomized to one of the     two arms to receive acupuncture plus pharmacological treatment (arm A) or pharmacological     treatment alone (arm B). Joint pain will be assessed by the BPI-SF score at baseline and six     weeks. All patients will have a baseline BPI worst pain item (#2) ≥3 points on a scale of     0-10.   "
227184|NCT00826410|"     The aim of the study is to determine wether subcutaneus suction drain (type redon-drain)     protect against surgical side infection by laparotomy in general surgery.   "
227185|NCT00826423|"     This study is short course (3 month) multiple drug antibiotic therapy. The purpose of this     research study is to evaluate the clinical and radiology response to assess whether drug     resistance develops and assess quality of life measures with MAC disease.   "
227186|NCT00826436|"     The primary purpose of this study is to assess the safety and tolerability of ascending,     multiple, oral doses of PRA-027 in Japanese postmenopausal women. The secondary purpose is to     evaluate the PK and PD profile of multiple oral doses of PRA-027 in Japanese postmenopausal     women.   "
227187|NCT00826449|"     The goal of the Phase I portion of this study is to find the highest tolerable dose of the     combination of dasatinib and erlotinib hydrochloride that can be given to patients with     advanced solid tumors.      The goal of the Phase II portion of this study is to learn if this combination is effective     when given to patients with non-small cell lung cancer.      The safety of this combination will be studied in both phases.   "
228527|NCT00847184|"     Time, success rate, and number of optimising maneuvers for tracheal intubation via the nasal     approach are not different when Aitraq technique is used compared to a standard MacIntosh     blade.   "
227188|NCT00826462|"     The purpose of this study is to compare the clinical effect of physiotherapy alone or     combined with corticosteroid injection in the initial treatment of lateral epicondylitis in a     primary care setting.      To find the short and long term effect of physiotherapy with Mill's manipulation, deep     friction massage and exercise therapy.      To ascertain wether the outcome is influenced by corticosteroid injection, which has been     shown to be of benefit alone in the short term?   "
227189|NCT00826475|"     Patients suffering from migraine will be randomly allocated to one of two different     behavioral interventions:        -  mindfulness based stress reduction (MBSR) an eight week intervention program based          different meditation & yoga techniques and teaching information regarding the          relationship between stress and health.        -  into an active control group teaching three times within eight weeks relaxation          techniques (progressive muscle relaxation PMR) and giving psychoeducation on migraine.          The investigators will measure the frequency and intensity of migraine attacks before          during and after the intervention as well as secondary variables on quality of life and          psychological functioning. The hypothesis is that patients allocated to the MBSR          intervention will reduce the frequency of their migraine attacks compared to the active          control group and compared to their own baseline.   "
227190|NCT00826488|"     The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2     dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the     appearance of non-calcified breast masses. It is thought that non-calcified breast masses     will be better visualized with the new 3D technology.   "
227191|NCT00826501|"     Patients with pancreatitis can develop inflammatory fluid collection around the pancreas     called pseudocysts. Pseudocysts may cause abdominal pain when they are more than 6cm in size.     These pseudocysts can be treated (drained) by surgery or by endoscopy. Both treatment options     are the current standard-of-care at all institutions around the World. The aim of this study     is to identify the better of the two techniques, surgery versus endoscopy, for treatment of     patients with pancreatic pseudocysts. This will be done by comparing a) the rates of     pseudocyst recurrence b) quality of life of patients following treatment and c) cost     associated with treatment, between both treatment modalities.   "
227192|NCT00826514|"     The purpose of this study is to determine whether tanezumab is effective in the treatment of     pain associated with chronic prostatitis.   "
227193|NCT00826527|"     The purpose of this study is to demonstrate that solifenacin post-operatively improves     irritative symptoms in men whose obstructive symptoms have been relieved with the GreenLight     laser outpatient procedure.   "
227194|NCT00826540|"     This phase II trial is studying how well giving sorafenib together with bevacizumab works in     treating patients with metastatic colorectal cancer. Sorafenib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Sorafenib and bevacizumab may also stop the growth of tumor cells by     blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more     tumor cells   "
227195|NCT00826553|"     The purpose of this study is to study the effect of two standard of care sedative medications     on sleep stages and total sleep time. The investigators hypothesize that the α2 agonist,     dexmedetomidine, will improve sleep quality by increasing N2 and N3 sleep as well as total     sleep time when compared to GABA agonists.   "
227207|NCT00826709|"     The primary objective of this study is to evaluate the fluID Rapid Influenza Test's ability     in detecting influenza A and influenza B from individuals presenting with signs and symptoms     of influenza-like illness (ILI).   "
227208|NCT00826722|"     The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets     under fasted conditions   "
227239|NCT00827125|"     The purpose of this study is to establish normograms of parameters measured by the LaborPro     system. To test the prediction of these parameters on labor progress and mode of delivery.   "
227196|NCT00826566|"     Nowadays it has become evident that a chronic systemic inflammation is present in patients     suffering from chronic obstructive pulmonary disease (COPD).      The role of the nuclear enzyme poly(adenosine diphosphate-ribose)polymerase (PARP) as a key     mediator within these systemic inflammatory processes as well as in COPD associated exercise     intolerance and muscle weakness could recently been identified. The attenuating effect of     dietary ingredients with PARP inhibiting activity on systemic inflammation was supported by     data from in vitro and in vivo studies, from other groups as well as from our own lab. We     identified several caffeine metabolites as potent inhibitors of the most abundant     PARP-isoform PARP-1 in-vitro, in animal models as well as in ex-vivo experiments with whole     blood from COPD patients.      However, clinical data with respect to their anti-inflammatory effects in COPD patients are     currently not available for none of these substances. Therefore, the current clinical pilot     study is intended to establish for the first time clinical data (proof of principle) on the     anti-inflammatory potential of caffeine metabolites.   "
227197|NCT00826579|"     The study is a feasibility and validation study of the sentinel lymph node (SLN) procedure in     all stages of colon cancer. If the SLN can be reliably identified, it could be submitted to a     more accurate histopathological examination (multiple sections, special staining). The     detection of micrometastases in the SLN (occult stage III, upstaging) is possible. Patients     with micrometastases should be considered at higher risk.      Additionally, a search for occult metastatic tumor cells in the bone marrow is performed.   "
227198|NCT00826592|"     The purpose of this study is to compare the effect of video-based patient education with     written instruction on subjects' knowledge of atopic dermatitis and their disease severity,     measured by the Patient-oriented Eczema Measure (POEM), after viewing the educational     materials.   "
227224|NCT00826930|"     The purpose of this study is to evaluate the impact of Trans Sodium Crocetinate (TSC) on     oxygen levels in brain tumor tissue in patients with high grade glioma. The proposed clinical     indication for TSC is a radiation sensitizer for the treatment of cancerous tumors.   "
227225|NCT00826943|"     The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine     (xyzal), and placebo differ in the degree of sedation they produce and their relief of     allergy symptoms.   "
227199|NCT00826605|"     The purpose of this study, then, is to search existing clinic and hospital records for     answers to the following two questions: (1) Do pregnant women who are at least 37 weeks     gestation and who have an increase in urubilinogen on urine dipstick at a prenatal     appointment have a statistically significant shorter average time before going into active     labor than their negative counterparts? (2) Do pregnant women who are at least 37 weeks     gestation and who show a modest weight loss between two prenatal appointments have a     statistically significant shorter average time before going into active labor than their     counterparts who did not lose weight?   "
227200|NCT00826618|"     Uveitic Cystoid Macular Edema (CME) is a major cause of visual loss associated with uveitis.     Systemic and/or local corticosteroid therapy and systemic immunosuppression with     steroid-sparing agents such as cyclosporine, methotrexate, azathioprine, or others,     effectively treats uveitis and associated CME in many patients. However, in many cases, CME     persists in spite of adequate suppression of uveitis. No consensus exists on how best to     treat such cases. The further addition of immunosuppressive agents appears to have little     effect on this form of CME. Oral corticosteroids are useful, but high dosage and prolonged     use can be associated with serious side-effects. Periocular and intravitreal corticosteroid     injections are associated with well-known, significant side effects such as glaucoma and     cataract formation.      Vascular endothelial growth factor (VEGF) is suspected to play a role in the loss of vascular     integrity in the eye and known to be induced by inflammatory cytokines, such as interleukin     interleukin (IL)-1β and IL-6, which are elevated intraocularly in uveitis. In addition, it     has been demonstrated that aqueous VEGF concentrations are statistically significantly higher     in those uveitis patients with CME than those without CME. Inhibition of inappropriate VEGF     activity is a potential approach to treatment of CME in uveitis given our current knowledge     of the pathophysiology of this condition and also because of the clinical need for additional     treatment options for these patients. Ranibizumab, a recombinant, humanized monoclonal     antibody antigen-binding fragment (Fab) that neutralizes all active forms of VEGF-A, would     target this pathway and may be useful in cases of persistent CME in uveitis patients.      The objective of this study is to determine if an anti-VEGF agent, Lucentis, is safe and     effective in leading to regression of macular edema due to chronic non-infectious uveitis in     patients with well-controlled uveitis.   "
227201|NCT00826631|"     Objective: To study the effect of fast food-based hyper-alimentation on liver enzymes and     hepatic triglyceride content (HTGC)and metabolism.      Design: Prospective interventional study with parallel control group. Setting University     Hospital of Linköping, Sweden. Participants: 12 healthy men and six healthy women with a mean     (SD) age of 26 (6.6) years and a matched control group.      Intervention: Subjects in the intervention group aimed for a body weight increase of 5-15% by     eating at least two fast food-based meals a day with the goal to double the regular caloric     intake in combination with adoption of a sedentary lifestyle for four weeks.      Main outcome measures: Weekly changes of serum aminotransferases and HTGC measured by proton     nuclear magnetic resonance-spectroscopy at baseline and after the intervention.   "
227202|NCT00826644|"     Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin     derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators     will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus     Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung     cancer.      Primary endpoints        -  to assess Response Rate      Secondary endpoints        -  to assess Overall response duration, Time to progression, Overall survival   "
227203|NCT00826657|"     We hope to learn the clinical and functional signs of sub-clinical vitamin B12 deficiency and     its response to supplementation in non-anemic, non-pregnant, and non-lactating women in Rural     Mexico. Vitamin B12 is important in hematopoiesis, neuro-cognitive functions and genetic     integrity. However vitamin B12 is only found in animal source foods therefore a large segment     of the population in developing countries and those practicing vegetarianism are at risk of     deficiency of the vitamin. This information will help decide weather supplementation with     vitamin B12 is necessary in such populations for public health reasons.   "
227204|NCT00826670|"     Multidrug-resistant Enterobacteriaceae producing extended-spectrum β-lactamases (hereafter     called ESBLs) have emerged as an important cause of bloodstream infection in hospitalized     patients and urinary tract infections in the community. As is the case with other     multidrug-resistant organisms chronic colonization is frequent, in the case of ESBLs mostly     intestinal and urinary carriage.      To the investigators knowledge no randomized, placebo-controlled clinical trial has been     performed to study the efficacy of a systematic ESBL eradication strategy. Eradication of     ESBL carriage would cause benefits for the individual patient - by reducing the risk of     infection - and for the community - by reducing transmission. Even if eradication turns out     to be impossible, transient suppression of ESBL might reduce the likelihood of transmission     and thus still be beneficial from an ecologic perspective.      The purpose of the proposed study is to test the hypothesis that the administration of a 10     day course of oral antibiotics active against ESBLs can lead to decolonization of ESBL     carriage in hospitalized patients.   "
227210|NCT00826748|"     The purpose of this study is to assess the effect of inhaled beclomethasone (an inhaled     corticosteroid) on the pattern of the lung airway epithelium and alveolar macrophages gene     expression of healthy smokers. We hypothesize that the administration of beclomethasone will     result in reversibility of some of the airway epithelium and alveolar macrophage gene     expression changes induced by cigarette smoking.   "
227211|NCT00826761|"     The aim of the ProSat study is to examine the effects of a probiotic capsule containing one     of two doses (low and high dose) of Lb. Casei on subjective appetite sensation, ad libitum     energy intake, and appetite hormone response in a single meal test and to determine whether     the acute effects persist after daily supplementation of the probiotic capsule.   "
227212|NCT00826774|"     The purpose of the study is to compare three methods of achieving weight loss in primary care     medical practice. The study will be conducted in six primary care practices. Weight     management will be provided to a total of 390 obese patients (who have 2 or more components     of the metabolic syndrome) by their own primary care providers, in conjunction with the     practices' auxiliary health professionals, including medical assistants.   "
227213|NCT00826787|"     The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets     under fed conditions   "
227226|NCT00826956|"     To investigate the changes of regional pulmonary blood flow in nondependent lung by     transesophageal echocardiography during one lung ventilation   "
227227|NCT00826969|"     The study objective is to investigate in a placebo-controlled, double-blind manner the effect     of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15     mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or     placebo will be inhaled once daily. The study duration consists of a treatment period of 4     weeks. The study will provide further data on safety of ciclesonide.   "
227214|NCT00826800|"     The purpose of this study is to see if giving chemo-therapy for colon cancer before surgery     can shrink the cancer and lead to a higher rate of cure than operating first and then giving     chemotherapy. Standard treatment for colon cancer is to first operate, and then, if the tumor     is advanced, give chemotherapy for about 6 months. However, surgery delays the time until     chemotherapy can start, since the body needs time to heal from the operation. During this     time any cancer cells that remain in the body that were not removed by the operation may be     allowed to grow. Giving chemotherapy first could attack the cancer cells right from the     start, not only at the tumor site that we know of, but also at the site of any cancer cells     that may have spread to other parts of the body. Another possible reason why giving chemo     therapy first might work better is that the blood vessels that feed the cancer cells are     intact before surgery and thus chemotherapy can travel directly to the cancer.      This study will also use the drug bevacizumab, in addition to the standard chemotherapy.     Bevacizumab has been on the market since 2004 for colon cancer that has spread to other     organs, but its use in earlier stage colon cancer, as planned in this trial, is still under     study.   "
227215|NCT00826813|"     More than half of patients with esophageal cancer are inoperable because of late stage cancer     or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom     of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the     quality of life of such patients, stent placement has been widely accepted to be an option     for palliation of the symptoms. However, recurrence of the neoplastic stricture remains a     challenge after stent placement. To combine the advantages of the immediate relief of the     esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a     novel esophageal stent loaded with 125I seeds has been developed in the authors' institute.     The preliminary clinical trial in a single institute has demonstrated better results than the     conventional stent. This prospective multiple center trial is designed to further demonstrate     the clinical outcomes with this irradiation, stent in patients compared to those using a     conventional covered stent.   "
227216|NCT00826826|"     The purpose of this study is to examine the overall effectiveness of short-time     anti-arrhythmic drug treatment with amiodarone (to control heart rhythm) to prevent short-and     long-term atrial fibrillation following an ablation procedure for atrial fibrillation.   "
227217|NCT00826839|"     Hundreds of thousands of couples in the United States experience infertility each year. When     initial measures do not help, some couples require a process called ovarian stimulation and     in vitro fertilization (IVF). Usually, a woman produces at most one egg each month. Ovarian     stimulation helps these women make more than one egg per month. However, this involves taking     hormones that stimulate the ovary to produce many eggs at one time. The stimulatory hormones     injected with a small needle. The eggs are removed from the ovary through a surgical     procedure and then placed in a dish for fertilization by sperm to form embryos. The embryos     are grown in the laboratory then replaced into the woman's uterus 3-5 days later.      The stimulation of the ovaries is important. Some patients undergo ovarian stimulation for     IVF but do not respond to the treatment. This is a very difficult situation because even     though several ovarian stimulation protocols have been used for poor responder patients, it     is not clear which protocol works best. In fact, two of the most commonly used protocols have     not been directly compared.      This study will randomize (like flipping a coin) couples with a history of low response who     are going to start IVF treatment into two groups. In one group the female partner will use a     protocol called E2 patch/antagonist. These women will use an estrogen patch and injected     antagonist for several days before starting injectable fertility medications. The other group     will use a protocol called OCP/microdose. This group of women will use oral contraceptive     pills (OCPs) and small doses of lupron along with the other injectable fertility medications.     We will then follow their progress to see how many eggs they produce and how many women get     pregnant.   "
227218|NCT00826852|"     The purpose of this study is:        -  to assess the efficacy of the combination in terms of Objective (clinical and          radiological) Response Rate        -  to assess the time to progression of the disease; assess the safety profile of the          combination, and assess the survival time.   "
227219|NCT00826865|"     The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets     under fasted conditions   "
227220|NCT00826878|"     This is a standard Phase 1b and 2a, multi-center, study design that will examine the safety,     tolerability, and maximum tolerated dose of tivozanib (AV-951) with this dosing schedule, as     well as overall response rate of tivozanib (AV-951) administration in NSCLC.   "
227257|NCT00827359|"     The purpose of this study is to determine if certain features of tumor specimens sampled     prior to therapy can predict for the likelihood of responding to everolimus.   "
227258|NCT00827372|"     The major purpose of this study is to determine if a new drug called pazopanib decreases     lymphedema in subjects previously treated for cancer. Lymphedema, or swelling of the arm, is     a result of damage to the lymphatic vessels in the arm during surgery and/or radiation. The     damaged vessels can not adequately drain fluid from the arm, resulting in increased pressure     and swelling. Pazopanib has not previously been studied as a treatment for lymphedema.   "
227221|NCT00826891|"     This is a single arm, open-label study in women from China who have Advanced (stage IVB)     Recurrent or Persistent cervical cancer to ⑴assess the response rate (i.e., CR + PR) of     Cisplatin combined with Topotecan in treatment of advanced (stage IVB) recurrent or     persistent Cervical cancer; ⑵assess the toxicities of CT regimen in treatment of cervical     cancer. Prior to treatment, written informed consent should be obtained from all patients.     Eligible patients will be assigned to CT regimen. The CT regimen is topotecan 0.75 mg/m2 IV     during 30minutes days 1, 2, and 3; followed by cisplatin 50 mg/m2 IV on day1, repeated every     21 days. The study will consist of two phases: the safety run-in phase and study phase.   "
227222|NCT00826904|"     The purpose of this study is to determine whether unrecognized maternal hyperglycemia and     postprandial lipemia early or late in gestation predicts excess neonatal adiposity.   "
227223|NCT00826917|"     Volumetry measurements can be a potential clinical use as non-invasive tools in prenatal     diagnosis and screening and helps to reduce the risk and complications of invasive     procedures. 3DUS volumetry gives more precise results than 2DUS volumetry measurements,     particularly, of irregularly shaped objects.   "
227228|NCT00826982|"     The major goal of this project is to reduce unnecessary pancreatic resections, namely     resection in those patients with non-regional lymph node metastatses that cannot be cured     with surgical resection. By combined minimally invasive methods for non-surgical biopsy and     highly sensitive molecular assays for cancer cells, we believe we can increase the ability to     detect distant lymph node metastases prior to surgical resection, and direct those patients     for more appropriate therapy (including possible neo-adjuvant chemotherapy with or without     surgery). We hypothesize that the combination of EUS-FNA and polymerase chain reaction (PCR)     of a multimarker panel will increase the sensitivity for malignant lymph nodes compared with     EUS-FNA cytology in patients with pancreatic ductal adenocarcinoma.   "
227229|NCT00826995|"     The purpose of this study is to compare the effect of video-based patient education with     written instruction on subjects' understanding of melanoma.   "
227230|NCT00827008|"     The purpose of this study is to investigate the long-term safety and tolerability and     efficacy of neramexane mesylate in the long-term treatment of subjective tinnitus after a     completed double-blind randomized placebo controlled study   "
227231|NCT00827021|"     Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life     in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESAs) are     the most used treatment option.      The purpose of this study is        1. the evaluation of biochemical markers to determine the efficacy of individual prediction          of ESAs therapy        2. to determine the benefits and harms of different ESA doses therapeutic strategy for the          management of anaemia of end stage kidney disease (ESKD).   "
227232|NCT00827034|"     This study will evaluate the potential drug-drug interaction of Dimebon with the     FDA-recommended CYP2C9 substrate warfarin in healthy subjects. Conformance with the guidance     includes general study design using a randomized, open label, single-dose warfarin,     steady-state Dimebon, 2-sequence, 2-treatment, 2-period crossover design with a minimum 7-day     washout period between treatments.   "
227233|NCT00827047|"     Total hemihepatic vascular exclusion(THHVE),completely isolates the right or left hemiliver     ipsilateral to the lesion that requires resection from the systemic circulation,has the     advantage of preventing backflow hemorrhage or air embolism without having to resort to caval     blood flow interruption of THVE.This study is to evaluate if THHVE can raduce bleeding,reduce     the incidence of complications and improve the patient's free survival and overall survival     compared with hemihepatic vascular clamping and Pringle maneuver.   "
227234|NCT00827060|"     Observation of the initial Procalcitonin values and the clinical course of consecutively     included patients with Acute Respiratory Tract Infections at general medical practices in     greater Hannover.   "
227235|NCT00827073|"     The purpose of this study is to determine if there is a difference on the penetration of     betadine 5% when using lidocaine 2% jelly versus topical tetracaine 0.5% in topical cataract     surgery. This will be assessed comparing bacterial colony count and species by taking swabs     from the eye surface before and after the topical anesthesia has been administered.   "
227236|NCT00827086|"     Environmental factors possibly influencing uveitis are evaluated.   "
227237|NCT00827099|"     RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood transplant     helps stop the growth of cancer cells. It may also stop the patient's immune system from     rejecting the donor's stem cells. The donated stem cells may replace the patient's immune     cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from     happening.      PURPOSE: This phase II trial is studying how well giving umbilical cord blood transplant     together with fludarabine, melphalan, and antithymocyte globulin works in treating patients     with hematologic cancer.   "
227238|NCT00827112|"     This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted     atazanavir can be expected to be safe and efficacious in treatment naive HIV infected     patients. Based on the results from this study, a confirmatory phase 3 study may be     conducted.   "
227240|NCT00827138|"     Rationale: DCC-2036 is a potent broad spectrum inhibitor of BCR-ABL kinase. Inhibition of     BCR-ABL has been validated for effective treatment of chronic myeloid leukemia (CML). The     emergence of mutant forms of BCR-ABL which resist inhibition by imatinib, dasatinib, and     nilotinib is associated with loss of efficacy in treatment of the disease. DCC-2036 is a     potent inhibitor of resistant mutants of BCR-ABL including the T315I mutation, and would     therefore be expected to effectively treat patients who fail to respond to other BCR-ABL     inhibitors. DCC-2036 also inhibits FLT3-ITD, TIE2, KDR, LYN and TRKA kinases. Purpose: to     assess the safety and tolerability in patients after continuous administration of DCC-2036     and to determine recommended doses for the conduct of a Phase 2 efficacy trial.   "
227241|NCT00827151|"     The adolescent and young adult years are a critical window in time for bone mineral accrual.     More than 90% of peak bone mass is achieved by 18 years, and data indicate that insults     sustained during adolescence and young adulthood may result in permanent deficits in bone     accrual. Adult athletes with amenorrhea (AA) have low bone mineral density (BMD) secondary to     hypogonadism, associated with increased fracture risk and associated co-morbidities. We will     examine whether estrogen replacement will increase BMD and improve measures of bone     microarchitecture in adolescents and young women with AA, thus optimizing peak bone mass.   "
227242|NCT00827164|"     The purpose of this feasibility study is to examine the effect of resistance training on     muscle strength, lean body mass, physical functioning, fatigue, and quality of life in head     and neck cancer patients receiving radiation therapy.   "
227243|NCT00827177|"     This is an open-label, dose-escalation study of ARQ 197 administered orally in combination     with sorafenib.   "
227244|NCT00827190|"     This is a first-in-human study of ILS-920. This study will provide an initial assessment of     the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ILS-920 after     administration of ascending single intravenous (IV) doses to healthy adult subjects.   "
227245|NCT00827203|"     The aim of this study is to determine the safety and tolerability of elesclomol sodium at     escalating doses (ultimately identifying the maximum tolerated dose). This study will also     characterize the pharmacokinetics of elesclomol and evaluate its anti-tumor activity in     advanced solid tumors that are metastatic and unresectable.   "
227246|NCT00827216|"     In this study the investigators want to investigate the effect of a short intravenous     infusion of Erythromycine on gastric emptying on patients considered full stomac and     scheduled for Emergency operation. A gastroscopy will be done after intubation to controll     the effect of the perfusion.   "
227247|NCT00827229|"     A clinical study was conducted to demonstrate the accuracy of the LaborPro System in     measuring fetal head station (from the pelvic inlet), cervical dilatation, and fetal head     position against manual/digital examination. The LaborPro obtained device values was compared     to measurements gathered within 15 minutes by manual/digital examination performed by two     independent physicians. The study was a non significant risk (NSR) device study.   "
227248|NCT00827242|"     The purpose of this study is to determine whether an experimental drug known as tadalafil     given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia     (straining, urinary frequency, feeling like your bladder is still full, etc.)   "
227249|NCT00827255|"     The objective of this retrospective chart review is to evaluate the patient characteristics,     treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05%     therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic     Emulsion 0.05% but discontinued use after less than 12 weeks of treatment.   "
227250|NCT00827268|"     This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have     poor reading skills following a stroke. Specifically, this study is designed to improve skill     in sounding out words for reading and spelling. The overall time commitment for participation     in this study is approximately 11-30 weeks.   "
227251|NCT00827281|"     This study examines whether isolated doses of D-cycloserine enhance the efficacy of CBT for     smoking cessation.   "
227252|NCT00827294|"     The goals of the study are to determine whether self-delivered, home-based mirror therapy     decreases the frequency and intensity of phantom limb pain and improves mood and physical     function in persons with phantom limb pain.      The investigators hypothesize that self-delivered home-based mirror therapy will     significantly decrease phantom pain intensity, will improve mood, and will improve function     at one-month follow-up.   "
227253|NCT00827307|"     The purpose of this study is to compare Zoladex plus tamoxifen with tamoxifen alone as     adjuvant hormonal therapy in pre- or perimenopausal women with early-stage breast cancer in     terms of breast density, estrogen levels, lipidemia, endometrial thickness and     ultrasonographic abnormalities.   "
227254|NCT00827320|"     The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets     under fed conditions   "
227255|NCT00827333|"     RATIONALE: Palliative care teaching sessions may be more effective than standard care in     improving caregiver burden, caregiver skills preparedness, quality of life, and distress in     family caregivers of patients with non-small cell lung cancer.      PURPOSE: This clinical trial is studying the effects of palliative care teaching sessions in     family caregivers of patients with non-small cell lung cancer.   "
227256|NCT00827346|"     Platelets are a major component of clot formation which can lead to clotting events such as     heart attack. During treatment for a heart attack, doctors try to remove this blockage as     quickly as possible so that the heart can recover and start to work properly again. The     standard of care at the Heart Institute for patients having a heart attack is a procedure     called a Percutaneous Coronary Angioplasty. A drug called Clopidogrel (Plavix) is routinely     used prior to the angioplasty to prevent blood clots. Patients usually remain on Clopidogrel     for at least one year following the angioplasty. Clopidogrel works by preventing the blood     from forming sticky substances called platelets, which clump together to form clots. Despite     the routine use of Clopidogrel, some patients still return to the hospital with another heart     attack, or with more chest pain. There is a growing body of evidence that recurrence of these     complications may be attributed to some patients having a poor response to Clopidogrel.      This pilot study will examine how platelets react to different doses of Clopidogrel given to     patients having a heart attack.   "
227260|NCT00827398|"     For numerous malignant diseases allogeneic hematopoietic stem cell transplantation (HSCT) is     the only curative therapy. One of the major complications is the occurrence of acute     graft-versus-host-disease (aGVHD). Thirty to eighty percent of patients after HSCT develop     aGVHD despite the prophylactic application of different immunosuppressive drugs.      The response rates to the conventional first line treatment are only 15-35%4. In case of a     steroid refractory aGVHD different therapeutic strategies have been evaluated, but with no     satisfactory results so far. The mortality of patients suffering from steroid refractory     aGVHD remains at 75-80%. Therefore, it remains important to search for new therapeutical     strategies for the treatment of aGVHD.   "
227261|NCT00827411|"     Our first hypothesis is that dose adjustment of aspirin and clopidogrel based on biological     monitoring reduces the rate of severe cardiovascular complications compared to a conventional     strategy in patients scheduled for drug eluting stent implantation and followed up for one     year. Our second hypothesis is that interruption of clopidogrel / Prasugrel after one year of     a combined therapy of clopidogrel/Prasugrel and aspirin is associated with a higher rate of     severe cardiovascular complications as compared with patients in whom aspirin and clopidogrel     / Prasugrel is maintained during the subsequent 6 months of follow-up.   "
227279|NCT00827645|"     The objective of this study is to determine whether women who are already receiving treatment     for their fibroids (ie. UAE) demonstrate improvement in urinary symptoms and sexual     dysfunction as well.   "
227304|NCT00827970|"     30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two     groups. The intervention group received an invitation to be tested for urogenital Chlamydia     trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group     received no intervention (21,000 individuals). Outcome measures: Number of tested     individuals, number of detected infections, number of women developing PID, ectopic pregnancy     or infertility, number of women giving birth to a child, number of women receiving IVF     treatment and number of men developing epididymitis.      The hypothesis was that more individuals would be tested and treated for infections and that     number of long term fertility complications would decline in the intervention group compared     to control group.   "
227305|NCT00827983|"     Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of     luteal support (S.C.) to an approved comparator (vaginal gel).   "
227262|NCT00827424|"     Scientific background:      Obesity is a known risk factor for cardiovascular disease, metabolic syndrome, and diabetes.     In Israel, the prevalence of obesity and diabetes among Arab females is 2 and 2.8 times     higher than Jewish females, respectively. The economic impact of obesity and overweight in     terms of illness, disease and lost productivity is estimated to amount to 2-9% of the     national health budget in countries with high GDP. Diabetics have medical expenditure that is     2.4 times higher than non diabetics per capita.      Lifestyle modification is an effective tool in reducing morbidity and health care expenditure     but despite that most family practitioners usually treat the complications of obesity rather     than preventing it.      PACE is a comprehensive health promotion guide in counseling patients to an active healthy     lifestyle. PACE is designed to assist the primary health care providers to promote physical     activity and dietary changes during routine office visits.      Objectives:      To asses the impact of PACE program on increasing the amount of physical activity, improving     clinical and metabolic indices, increasing the documentation of lifestyle indices in the     medical records and reducing health care expenditure and utilization.      Working hypothesis:      Implementing a modified PACE protocol can achieve this objectives in Arab women.      Methodology:      The investigators will conduct a structured, multidisciplinary and continuous primary care     based intervention, assisted by trained health promoters and applying a locally adjusted PACE     protocol.   "
227263|NCT00827437|"     The primary aim of this single site study was to assess the feasibility of implementing a     staff/parent communication intervention within 72 hours of the parents making an end-of-life     decision on behalf of their child.   "
227264|NCT00827450|"     This study will assess        -  whether coffee consumption protects against fructose-induced hepatic steatosis in          healthy humans        -  whether the protective effect of coffee is dependent on it's antioxidant composition   "
227265|NCT00827463|"     Estimate the efficiency of a strategy of premature screening of the maternal anaemia during     the first quarter of pregnancy versus the usual strategy of screening of the anaemia during     the sixth month.   "
227266|NCT00827476|"     we will perform xenotransplantation and in vitro culture of ovarian tissue from patients     undergoing ovarian cortex cryopreservation.   "
227267|NCT00827489|"     The purpose of this study is to assess the safety and tolerability of ascending single oral     doses of HTC-867 in healthy young and elderly subjects. This study will also evaluate the way     the drug enters and leaves the blood and tissues over time and how the drug acts on and in     the body in a fasted and fed state.   "
227268|NCT00827502|"     To assess effectiveness of Trulimax (Azithromycin) in Acute Bacterial Upper Respiratory Tract     Infections (URTIs).   "
227269|NCT00827515|"     Initial studies have used a powder in capsule formulation of PH797804. In future studies an     immediate release tablet will be used. The purpose of this study is to compare blood levels     of PH797804 following an oral dose of the powder in capsule formulation and the tablet     formulation. In addition the effect of food blood levels of PH797804 will be investigated   "
227270|NCT00827528|"     The objective of this study is to evaluate surgical treatment of anterior vaginal wall     prolapse using the sis graft or traditional repair. This a randomized and prospective study.     Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in     quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with     FSFI and possible complications.   "
227271|NCT00827541|"     This is a study to evaluate the safety of tigecycline in patients with complicated     intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI)     under real practice in the usual hospital setting and patients' conditions, in order to     assess the real incidence of adverse events related with tigecycline in these patients.   "
227272|NCT00827554|"     Hepatocellular carcinoma (HCC) is a major tumor type worldwide, especially in China as the     sequence of hepatitis B and liver cirrhosis. Activation of the coagulation system occurs     commonly in patients with malignancy. Several studies have suggested that anticoagulant     therapy may improve survival in patients with malignancy. The low molecular weight heparins     (LMWHs) lend themselves to such studies because of their effects in experimental models of     malignancy and the relative ease of administration compared with unfractionated heparin. The     purpose of the present RCT was to determine whether addition of LMWH to transarterial     chemoembolization (TACE) would improve HCC patient outcome compared with TACE alone.   "
227273|NCT00827567|"     The hypothesis of this clinical research study is to discover if the study drug RAD001 can     shrink or slow the growth of Estrogen Receptor/Progesterone Receptor (ER/PR) negative or     Human Epidermal growth factor Receptor 2 (Her2 Neu) negative breast cancer. The safety of     RAD001 will also be studied. Patients physical state, symptoms, changes in the size of the     tumor, and laboratory findings obtained while on-study will help the research team decide if     RAD001 is safe and effective.   "
227274|NCT00827580|"     A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS)     following capecitabine (Xeloda).   "
227276|NCT00827606|"     The purpose of this study is to characterize three year descriptive growth and development     (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in     pediatric subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin     treatment.   "
227277|NCT00827619|"     This study is intended to evaluate the long-term effectiveness of treatment of de novo or     restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™     Vascular Stent which has received the CE mark for commercial use. The study is designed as a     single arm non-randomized post-approval study.   "
227278|NCT00827632|"     There is a large gap between lowest expected failure rates of about 1.5% and typical use     failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral     contraceptive (OC) effectiveness in population subgroups. Recent reports suggest greater OC     failure among heavier women, particularly those using the lowest doses. The prevalence of     obesity in the US population has recently increased to about 23% in women aged 20-29, peak     years for OC use. OC physiology and effectiveness have not been evaluated in obese women. We     propose a double blind randomized clinical trial to include normal weight and obese women who     have normal ovulatory function at baseline; we will randomize women to 2 widely used OCs and     evaluate ovarian follicle development and circulating progesterone to assess ovarian     suppression during OC use.   "
227280|NCT00827658|"     Ulnar nerve blockade is necessary for sensory anesthesia and analgesia in the hand during     minor procedures. The course of the ulnar nerve in the forearm, wrist, and hand is     predictable and has low variability. However even with known anatomic location and landmarks,     ulnar nerve blocks at the wrist frequently are inadequate for procedural anesthesia. The     antebrachial fascia at the wrist acts as a barrier to local infiltration. Since the fascia     can not be visualized or palpated, it is commonly is not penetrated, resulting in an     inadequate block. Furthermore at the level of the wrist the ulnar artery lies in close     proximity to the nerve and there is potential for arterial puncture while attempting     injection for volar wrist block. The palmar ulnar nerve block is an injection distal to the     hook of the hamate in the thenar eminence which avoids the ulnar artery and antebrachial     fascia. This block has been used successfully for many years in clinical practice but has not     been assessed or compared in a research study. The purpose of this study is to assess the     validity of using a palmar ulnar nerve block for procedures in the hand as compared to the     standard volar wrist ulnar nerve block.   "
227281|NCT00827671|"     The purpose of this study is to determine whether the addition of the combination between     cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is     safe and adds efficacy.   "
227282|NCT00827684|"     The purpose of this study is to investigate the safety and efficacy of temsirolimus as a     single drug, and of temsirolimus in combination with irinotecan in chemotherapy resistant     patients with KRAS mutated colorectal cancer.   "
227283|NCT00827697|"     Our hypothesis is that nucleic acid amplification testing (NAAT) with the APTIMA Combo2 (AC2)     will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal     samples. We also hypothesize that AC2 will be equivalent to NAAT with the Becton Dickinson     ProbeTec in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.   "
227284|NCT00827710|"     Can we improve diabetes outcomes through 1) report card mailings to patients 2) point of care     distribution of report cards to patients and 3) provider performance feedback with patient     level data?   "
227285|NCT00827723|"     The aim of the investigators' study is to elucidate the relationship between a functional     liver test (e.g., ICG) and the PREOPERATIVE value of portal hypertension in the patients with     impaired liver function from alcoholic and non-alcoholic aetiologies. Alcoholic and viral     cirrhosis present important differences in terms of cellular mechanisms responsible for the     disease progression with a distinct and unique gene expression pattern that regulates the     type of inflammatory response. These differences probably influence the hepatic functional     reserve and the onset of portal hypertension at a comparable clinical and biological level of     derangement and the investigators may expect significant differences in the recovery from     hepatectomy.      The investigators' hypothesis is that at a comparable ICGR-15 rate non-viral cirrhotic liver     presents higher portal pressure values and the investigators also argue that alcoholic     cirrhotic patients would tolerate a larger hepatic resection than would viral cirrhotic do.   "
227286|NCT00827736|"     The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared     to a relatively new treatment (injection of Botox in the internal anal sphincter). The study     hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison     is done blinded for the surgeon and the patient.   "
227287|NCT00827749|"     The purpose of this study is to evaluate the efficiency of a novel non-invasive method for     swallowing disorders detection in geriatrics.   "
227288|NCT00827762|"     The purpose of this study is to determine whether improvements in behavior occur in children     with phenylketonuria (PKU) who are taking Kuvan.   "
227289|NCT00827775|"     1. To determine in a cross sectional case-controlled cohort study of 50 hemodialysis          patients if blood pressure elevations with hemodialysis are associated with decreased          endothelial cell function (measured by brachial artery flow mediated dilation and          endothelial progenitor cell number), both of which are novel mechanistic markers in the          causal pathway for detrimental cardiovascular outcomes; and        2. To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood          pressure elevations with hemodialysis can improve endothelial cell dysfunction as a          surrogate mechanistic marker for improving cardiovascular outcomes.   "
227290|NCT00827788|"     The purpose of this study is to determine the incidence of contrast induced nephropathy and     myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide     administration in patients with acute myocardial infarction undergoing primary PCI.   "
227314|NCT00821418|"     The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™     on patients with COPD, as measured by the change from baseline in full pulmonary functions,     oxygen saturation, exercise tolerance and health related quality of life; and to assess the     ease of use of PulseHaler™ by the patients.   "
227291|NCT00827801|"     Primary Objective:      To determine if there is a reduction in the mean symptom severity scores for the heart     failure specific symptom items between baseline and at the end of three months between     patients whose symptoms are managed using the MDASI-HF symptom assessment scores (treatment     group) as a decision making guide, as compared to patients managed without using the MDASI-HF     symptom assessment scores (control group).      Secondary Objectives:        1. Examine the correlation between mean symptom severity scores and the secondary endpoints          of: a) exercise tolerance ( 6-minute walk), b) NYHA (New York Heart Association)          functional classification, c) B-type natriuretic peptide (a biomarker for heart          failure), and d) dose titration of HF (heart failure) medications.        2. Define symptom severity critical values in cancer patients with concurrent heart failure          that trigger clinical intervention        3. Identify symptom clusters which may occur in cancer patients with concurrent heart          failure.   "
227306|NCT00827996|"     The trial is a 12-week phase 2 study. Subjects will be given subcutaneous injections at weeks     0 (160mg), 2 (80mg), and then every other week (40mg) until week 12 in subjects with moderate     to severe hidradenitis suppurativa.   "
227374|NCT00822224|"     Acute pain is frequent in elderly especially in geriatrics acute care units where painful     procedures are often occurring.      MEOPA represents an alternative to opioïd therapy to prevent procedural pain during the     treatment of pressure ulcers.      In this study, cognitive impairment and dementia do not limit the use of MEOPA. The new     approach in the management of acute procedural pain provides effective and safe analgesia in     frail old patients.   "
227292|NCT00827814|"     Increased bladder mass occurs as a consequence of bladder outlet obstruction in animals and     patients, and relief of bladder outlet obstruction reverses an increased bladder mass.     Whether increased bladder mass is not only a consequence of bladder outlet obstruction but     also a relevant risk factor for the progression of lower urinary tract symptoms associated     with benign prostate hyperplasia cannot be decided due to a lack of appropriate data, most     likely because bladder wall thickness is not routinely measured in clinical studies and/or     routine clinical practice. Despite this lack of data, many urologists feel that increased     bladder mass should be prevented or decreased to reduce the occurrence of serious     complications.      The possibility of using bladder wall thickness data as criteria for benign prostate     hyperplasia intervention and as outcome criteria for benign prostate hyperplasia treatment     has been proposed. Detrusor hypertrophy associated with bladder outlet obstruction can be     imaged on suprapubic ultrasound, and bladder mass can be quantified from the evaluation of     bladder wall thickness and bladder volume. Bladder wall hypertrophy has been found to be     correlated with detrusor function.      Independent studies have shown that surgical treatment of benign prostatic obstruction     results in a significant decrease of bladder mass. Preliminary data suggest the possibility     that medical treatment with alpha-adrenergic antagonists might also produce a reduction of     bladder wall hypertrophy.      The investigators assume that the prevention of benign prostate hyperplasia progression by     alpha-adrenergic antagonists and 5 alpha reductase inhibitors may be result of bladder     function protection. To our knowledge there have been no studies that evaluated the effects     of a 5 alpha reductase inhibitors on bladder function. Therefore, the investigators plan to     conduct a prospective trial evaluating the effects of 5 alpha reductase inhibitors on bladder     function by the evaluation of bladder wall thickness and lower urinary tract symptoms.   "
227293|NCT00827827|"     Chronically disabled stroke survivors experience accelerated skeletal muscle atrophy and     other detrimental changes to muscle and surrounding tissues on the paretic side. This     unilateral tissue-level damage contributes to worsening disability and insulin resistance.     This VA Merit Award will advance the investigators' understanding of the potential for     strength training (ST) to reverse stroke-related muscle abnormalities to improve metabolic     health, strength, and function. It will be the first study to thoroughly investigate the     effects of ST on muscle atrophy, intramuscular fat, muscle fiber characteristics, capillary     density and insulin sensitivity after stroke.   "
227294|NCT00827840|"     Primary objective: To examine whether the switch to paliperidone ER from risperidone improves     cognitive function in stabilized patients with schizophrenia.      Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after     switching to paliperidone ER from risperidone   "
227295|NCT00827853|"     Despite recent advances in stent technology and its widespread application in the treatment     of peripheral vascular disease (PVD), incidences of partial or complete blockage of stent     lumen (in-stent restenosis) due to in growth of cells (neo-intimal proliferation) is     unacceptably high.      In diabetics with long superficial femoral artery (SFA) lesions, in-stent restenosis rates     are higher than in non-diabetics. Consequently interventional techniques that curtail     in-stent restenosis have to be explored. Cryoplasty is a stent expansion method in which a     balloon is expanded using pressurized nitrous oxide gas. As the nitrous oxide expands in the     balloon it cools the surroundings to about -10 degrees C. This induces programed death     (apoptosis) of the smooth muscle cells in arterial wall.      The investigators hypothesize that Cryoplasty, by inducing an apoptotic smooth muscle cell     response, when applied to post-dilation of nitinol self-expanding stents in the Superficial     Femoral Artery (SFA) of diabetics, would lead to decreased in-stent restenosis due to     decreased neointimal proliferation.   "
227296|NCT00827866|"     The proposed study is a two-armed randomized controlled clinical trial examining the     long-term (one-year) efficacy of telephone intervention conditions for smoking cessation in a     high risk medical population; namely, cancer survivors: Proactive telephone recruitment     through the Childhood Cancer Survivors Survey (CCSS) St. Jude Life Study, After Completion of     Therapy (ACT) Clinic and face to face recruitment at the local West Clinics will serve as the     primary methods of recruitment.      The specific aims of the study :      (1) To recruit nationally a cohort of approximately 1242 smokers who are cancer survivors(621     childhood cancer survivors and 621 adult cancer survivors); 2) To determine the long-term     (one year) efficacy of the intervention condition for participants randomly assigned to the     Counselor-initiated versus a Self-paced QL; and (3) to find out whether treatment outcomes     vary as a function of survivors' age of cancer diagnosis (survivors who diagnosed while     adults vs. childhood cancer survivors who diagnosed before the age of 21).   "
227297|NCT00827879|"     The purpose of the project is to develop and test a couples-based relationship enhancement     group intervention for married or partnered Operation Enduring Freedom (OEF)/Operation Iraqi     Freedom (OIF)/Operation New Dawn (OND) veterans to prevent the perpetration of intimate     partner aggression (IPA) among participants.   "
227298|NCT00827892|"     Intracerebral hemorrhage (ICH) is a devastating disease with less than 20% of survivors being     independent at 6 months. There is currently no approved treatment for ICH which has been     shown to improve outcomes. In an effort to develop a new treatment for ICH, this research     focuses on a different aspect of ICH treatment which has not yet been evaluated: enhancing     absorption of the blood clot with medication.   "
227299|NCT00827905|"     The purpose of this study is to determine whether the respiratory rate provided by the Kai     Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is as accurate as that provided by     the Welch Allyn Propaq Encore model 242 and the Embla Embletta system with Universal     XactTrace respiratory effort sensor and Somnologica for Embletta software.   "
227300|NCT00827918|"     A study to evaluate the safety and efficacy of treatment with MK-8998 as compared to placebo     and olanzapine for acutely psychotic patients with schizophrenia. The primary hypothesis is     that in participants undergoing an acute psychotic episode of schizophrenia, MK-8998 6 to 8     mg twice daily is superior to placebo in the treatment of symptoms of schizophrenia as     measured by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS)     total score at Week 4.   "
244182|NCT01055210|"     An evaluation of the role of resting and exercise cardiac output measurement, by the inert     gas rebreathing method, in optimisation of patients with cardiac resynchronisation     pacemakers.   "
227301|NCT00827931|"     Tranexamic acid has been shown to reduce postoperative blood losses and transfusion     requirements in various types of major surgery (orthopedic surgery, spine surgery,     cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is     being conducted to compare the efficacy of tranexamic acid plus standard of care versus     standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.   "
227302|NCT00827944|"     The objective of the study is to evaluate pain and disabling complications inducing social     consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair     with lightweight polypropylene mesh.   "
227303|NCT00827957|"     Controlled therapeutic hypothermia is a method of preserving neurological function     post-resuscitation.It has been associated with improved functional recovery and reduced     histological deficits in animal models of cardiac arrest.   "
227307|NCT00828009|"     RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine     therapy together with bevacizumab after chemotherapy and radiation therapy may kill more     tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving BLP25 liposome vaccine     together with bevacizumab after chemotherapy and radiation therapy in treating patients with     newly diagnosed stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by     surgery.   "
227308|NCT00821340|"     The purpose of this clinical trial is to examine the safety of gene therapy for Lebers     Congenital Amaurosis (LCA) caused by RPE65 mutations using a recombinant adeno-associated     virus serotype 2 (rAAV2) vector carrying the human RPE65 (hRPE65) gene. Recently, three     independent short-term gene therapy studies in humans with LCA due to RPE65 mutations were     published, suggesting that subretinal delivery of rAAV virus carrying the RPE65 gene is safe.     As a secondary outcome, improvement in visual function was observed in seven of the first     nine treated patients. The proposed study is a similar open label, Phase I clinical trial of     uniocular subretinal rAAV2-hRPE65 administration to individuals with RPE65-associated retinal     disease. Two cohorts of three subjects each and one cohort of four subjects will be included     in this trial. Cohort 1 and 2 will consist of individuals 18 years of age and older and     Cohorts 3 will consist of individuals 8 years of age and older. In cohort 2, a larger volume     of vector will be administered. Enrollment in Cohort 3 will begin only after confirming the     safety of rAAV2-hRPE65 administration in the older group of participants.   "
227309|NCT00821353|"     Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients     with hypertrophic cardiomyopathy (HCM) and represents an important complication in the     clinical course of the disease, with adverse long-term consequences on functional status and     outcome.      Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus     rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is     challenging because of the limited long-term efficacy and potentially hazardous side effects     of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is     successfully used in clinical practice. However, comparison of the efficacy and safety of     these two therapeutic options has not been done up till now in randomized manner in this     group of patients.      Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs.     antiarrhythmic drug therapy in patients with HCM and AF.   "
227310|NCT00821366|"     The aim of this study is to investigate the benefits of ARV treatment to patients, to the     family members of patients on ARV treatment, and to communities at large. The study also aims     to investigate the impact of a peer adherence support and a nutritional intervention on     measures of treatment success. To this end, 648 patients who had commenced ARV treatment in     the past month at twelve selected health care facilities will be recruited into the study. In     addition, 204 randomly sampled households from the communities served by the twelve selected     clinics will be recruited into the study. Trained enumerators will at baseline conduct     semi-structured interviews with patients and households. Following the baseline survey,     patients recruited into the study will be randomly assigned to one of three groups:        -  Patients receiving ARV treatment and the associated support currently provided in the          public sector ARV treatment programme.        -  Patients receiving (a) plus bi-weekly visits by an experienced ARV patient who has been          trained as a peer adherence supporter        -  Patients receiving (a) and (b) plus a weekly nutritional supplement in the form of two          400g cans of meatballs and spaghetti in tomato sauce The group of 'comparison'          households comprises the fourth group. Trained enumerators will conduct follow-up          interviews with all patients and households at approximately six- and at twelve-months          respectively. In addition, the ARV coordinator and other providers working in the ARV          treatment programme at each of the twelve selected health care facilities will be          interviewed by trained enumerators, at baseline and again at six- and at twelve-months.          Clinical data will be obtained from patient files at baseline and at completion of the          study. Using these data, various outcomes of importance to the study will be compared          between the four study groups, using experimental and non-experimental methods.   "
227311|NCT00821379|"     The CoPPer study is a follow-up study of women diagnosed with Polycystic Ovary Syndrome     (PCOS). Women will be included pre-conceptional and followed-up until after delivery. The     investigators will design a multivariate prediction model of pregnancy outcome in women with     PCOS with the intention to define intervention strategies for the future.   "
227312|NCT00821392|"     This study was designed to evalute the efficacy and safety of Febuxostat after oral     administration to patientd with gout in Korea   "
227313|NCT00821405|"     Use ultrasound and computed tomography to evaluate the condition of peritoneum(thickness,     calcified, etc. )and correlate the relationship between the peritoneum and other clinical     condition   "
227315|NCT00821431|"     A prospective, Phase II, stratified, randomized study to compare the safety, ulcer healing,     patient compliance (concordance) and resource utilisation of a compression device with IPC     mode to a Class 3(c) UK standard graduated compression regime (4- layer system) on subjects     with venous leg ulcers.   "
227316|NCT00821444|"     Commercial ziprasidone capsules show a large increase in bioavailability with food. The     formulation tested in this study aims to reduce or eliminate that increase.   "
227317|NCT00821457|"     Renovo, a Biopharmaceutical company involved in the development of drugs to improve the     appearance of scars and enhance wound healing, are proposing to carry out research in     improving the appearance of existing scars that are 2-6 months old using Juvista. Juvista has     not previously been administered to pre-existing scars without surgical revision, but it is     thought that some beneficial effects seen with Juvista in previous trials may also be seen     when administered to existing scars whilst the scar is maturing. This proof of concept study     will therefore investigate the effect of Juvista in Caucasian male and female patients when     administered to scars that are between two and six months old.      Scarring in the skin can vary hugely between individuals; therefore the most reliable way to     assess the efficacy of an improvement of scar appearance is to use a model where each patient     acts as their own control. A placebo will also be used for this trial as there are currently     no approved pharmaceuticals for the improvement of scarring.      A total of 20 patients will be allocated to one of two dosing groups. Patients who enter the     study will have linear scars resulting from broken skin (e.g. trauma, surgery) between 7 and     20cm in length, as well as meeting other specific criteria. The scar to be treated will be     divided into two equal segments. Each segment will receive an intradermal injection of     Juvista or placebo on Day 0 and 24 hours later.      The measure of change in scar appearance will be performed using colour analysis which will     assess the change in colour between the Juvista treated segments versus the placebo treated     segment of the scar, with reference to the surrounding skin within each patient.   "
227318|NCT00821470|"     Aseptic non traumatic osteonecrosis (ON) is a painful disorder of the hip which often leads,     in its final stage, to femoral head collapse and subsequent total hip replacement. Core     decompression of the hip is the most widespread procedure used to treat early stage ON of the     femoral head. Notwithstanding the fact that this procedure has been employed for more than     three decades (2), its efficacy remains controversial (3;4). Recently, one suggested that ON     might be a disease of bone cells and/or of mesenchymal cells. The levels of activity and the     number of mesenchymal stem cells in both the hematopoietic and in the stromal compartments of     the bone marrow have been shown to be depressed in patients with ON of the femoral head (9).     The investigators have showed previously that the capacity of osteoblastic cells to replicate     was decreased in the proximal femur of patients with ON of the femoral head (10). This     finding raised the possibility that bone marrow containing stromal cells which have many of     the characteristics of stem cell for mesenchymal tissues including bone could be implanted     into the necrotic lesion of the femoral head.   "
227319|NCT00821483|"     The purpose of this study is:        1. To compare the efficacy of a single dose of Frovatriptan 2.5 mg with that of placebo in          acute treatment of up to one migraine attract        2. To assess recurrence rate between two group        3. To assess the safety and tolerability   "
227320|NCT00821496|"     This study is desgigned to look at the effect of multiple dosing administration of VI-0521 on     Oral Contraceptive medication.   "
227321|NCT00821509|"     Improved hand hygiene is known to reduce transmission of both respiratory (RTI) and     gastrointestinal infections (GTI) under semi-closed conditions such as hospitals, day-care     centres and schools. It is not known if similar interventions would have the desired effect     in a regular office work. This study is aiming to investigate this possibility by recruiting     volunteers from several companies in the Helsinki Region. The two intervention groups will     receive detailed instructions e.g. for proper coughing and sneezing, and for regular cleaning     of hands with either standard liquid soap or with alcohol-based gel rubbing. Third group will     serve as the control and is advised not to change their previous behaviour in this respect.     The participants will report weekly possible RTI or GTI symptoms and related days off through     internet. The study is planned to run about 18 months to cover the seasonal variation of the     epidemics of the causative different viruses.   "
227322|NCT00821522|"     Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its     pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic     preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing     coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the     incidence of acute kidney injury associated with cardiopulmonary bypass.   "
227323|NCT00821535|"     To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg     maraviroc in healthy male Japanese volunteers.   "
227324|NCT00821548|"     The investigators evaluated clinical tolerance, biological tolerance, feasibility and     efficacy of daily electrostimulation training of shoulder girdle and quadriceps muscles in 10     patients with facioscapulohumeral muscular dystrophy, the third most common inherited     myopathy.   "
227325|NCT00821561|"     The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with     Persistent Epithelial Defects (PED) originally caused by chemical burns.   "
227326|NCT00821574|"     This study will evaluate the efficacy of a multi factorial preventive scheme of action     (including fluvastatin and valsartan) to reduce the overall risk level in patients with     metabolic syndrome.   "
227327|NCT00821587|"     The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug,     on the clearance of the hepatitis C virus in liver transplant subjects being treated with     peg-interferon and ribavirin.   "
227328|NCT00821600|"     The purpose of this study is to explore the pharmacokinetics, safety and tolerability of a     4-week long-acting injectable (LAI) formulation of risperidone after single intramuscular     (i.m.) injection of 75 mg risperidone LAI in the gluteal muscle.   "
227329|NCT00821613|"     Collection of thermal images of women with breast tumors in varying degrees of severity and     of healthy women with no breast findings, in order to evaluate and improve Real Imaging's     device (RI4.0), capabilities which will assist in early detection of breast cancer.   "
227330|NCT00821626|"     Influenza is a frequent cause of fever in returning travelers. Usually diagnosis rests on the     clinical picture. Rapid flu tests are becoming increasingly popular, although their     sensitivity and specificity are suboptimal. The objective of this study is to evaluate if     rapid flu tests influence the medical management of returning travelers with fever, a     population at intermediate risk for influenza infections.   "
227331|NCT00821639|"     The purpose of this study is to assess the effects of a health center based counselling     method for the prevention of infant exposure to secondhand smoke.   "
227332|NCT00821652|"     The study is designed to see if a course of injections containing the NY-ESO-1 protein (a     tumor antigen, marker expressed by tumors); in combination with an immune stimulant     (adjuvant) Montanide, with or without resiquimod (another adjuvant) is well tolerated and     safe in patients with surgically resected Stage IIB, IIC, Stage III or Stage IV (AJCC     criteria) melanoma, a tumor that expresses NY-ESO-1. In addition, this study is designed to     see if the patient's body's defense (immune) system can be boosted (strengthened) by this     vaccine and if the addition of resiquimod to the vaccine makes this more likely.   "
227333|NCT00821665|"     Hyperglycemia forms a direct and independent risk factor for the development of     cardiovascular co-morbidities in type 2 diabetes. Consumption of sucrose-sweetened soft     drinks might further increase the prevalence of hyperglycemic episodes.      The objective of the study was to assess glycemic control in type 2 diabetes patients and     healthy lean and obese controls under strict dietary standardization but otherwise free     living conditions, with and without the consumption of soft drinks.   "
227357|NCT00822003|"     The investigators aimed to investigate the pharmacokinetic and pharmacodynamic effects of a     single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT)     in 16 healthy males   "
227375|NCT00822237|"     This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured     with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly     administered with M-M-R II in healthy children.   "
227334|NCT00821678|"     The purpose of this study is improved outcomes for veterans with Post Traumatic Stress     Disorder (PTSD) treated in small VA Community Based Outpatient Clinics (CBOCs). Although     psychotherapy and pharmacotherapy treatments for PTSD have been proven to be efficacious in     controlled trials, geographic barriers often prevent veterans from accessing these     evidence-based treatments. Telemedicine technologies will be used to overcome geographic     barriers to care. Specifically, we will evaluate the Telemedicine Outreach for PTSD (TOP)     intervention which is based on the principals of the Chronic Care Model and Disease     Management, and builds on the evidence base of quality improvement for depression in primary     care settings. The TOP intervention will employ an off-site PTSD care team     (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will     use telemedicine technologies (telephone, interactive video and electronically shared medical     records) to treat CBOC patients with a newly emerging or chronic PTSD. We hypothesize that     study participants randomized to the TOP intervention will receive higher quality of care and     experience better outcomes compared to study participants randomized to treatment as usual.   "
227335|NCT00821691|"     The objective of the study is to test the action of the amantadine, as DOPA-agonist, in a     double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post     stroke aphasic patients.   "
227336|NCT00821717|"     This study is designed to assess, relative to placebo, the effects on the evolution of     exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric     carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic     CHF (congestive heart failure) and iron deficiency.   "
227337|NCT00821730|"     nflammatory arthritis (IA) is a major cause of long-term disability. Due to specialist     shortages, failure of primary care providers and individuals to recognize the disease, and     lack of awareness of the importance of early intervention, delays to rheumatologic care are     common. Peer support models have been used for various health issues and may be one method to     assist individuals with early IA to manage their disease and cope with stress. One-on-one     semi-structured interviews will seek out feedback on a peer support approach and explore the     learning needs (informational needs, educational preferences) and opinions about emotional     and appraisal support of individuals living with IA from the perspectives of family and     friends. The data will be analyzed and expressed themes (articulated needs and understandings     of interviewee context) will guide the future development of a peer support intervention.   "
227338|NCT00821743|"     Disturbance of posture, gait and balance usually appear several years after Parkinson's     disease (PD) onset. These axial signs, generally resistant to conventional drug and non-drug     treatment, can generate a loss of autonomy and traumatic complications. Improvement of these     axial signs by deep brain stimulation (DBS) of the pedunculo-pontin nucleus (PPN) has been     described for a small number of patients. The objectives of the present prospective     monocentric pilot study are to determine the optimal stimulation parameters of PPN-DBS, to     evaluate the long term tolerance and the effect of PPN-DBS on axial signs and quality of life     in five patients with severe PD. The use of detailed clinical rating scales and quantitative     computer-based gait analysis will allow to identify the optimal stimulation parameters and     relevant clinical efficacy parameters, mandatory for the design of further comparative     large-scale studies.   "
227339|NCT00821756|"     Background:      Repetition rate after a suicide attempt and self harm is very high, about 12-30 percent.     Studies, reviewed by Hawton, 1999 show a lack of evidence for psychosocial interventions.     Compliance with aftercare is also often very poor.      Objective:      Inspired by the Norwegian Baerum project, the aim is to study if active, assertive outreach,     seeking contact, talking about problem solution, motivate to comply to other appointments,     will reduce repetition of suicidal acts in the following years.      Methods:      The design is a prospective randomized, controlled trial. The patients (immediately after a     suicide attempt or deliberate self harm)) included are randomized to intervention or standard     (treatment as usual), aiming at at least 60 persons in each arm. The intervention is carried     out through research nurses with about 8 home visits, phone contact, phone messaging,     e-mails.Included are persons 12 years of age and older, danish speaking without translator     and without diagnoses of severe mental illness (schizophrenia, bipolar illness, mania and     severe/psychotic depression) or severe dementia.      Results:      Outcome is measured by repetition of suicidal act (suicide attempt, self harm or completed     suicide)as recorded in medical records and by the Danish Cause of Death Register. Repetition     measured by persons and by acts throughout 1 year, 2 and 3 years periods. Additional outcome     is number and character of health system contacts.   "
227340|NCT00821782|"     Evaluation of bacteria in the mouth and throat before study drug ( Levofloxacin,     floroquinolone antibiotic and Azithromycin, a macrolide antibiotic) is started and then     periodically for 6 weeks after the last dose of study drug is taken   "
227341|NCT00821795|"     Volunteers are being invited to take part in a research study about insulin therapy of     diabetes. They are being invited to take part in this research study because they have     diabetes and have an illness requiring hospitalization. If they volunteer to take part in     this study, they will be one of about 120 people to do so. The investigators hope to answer     the following research questions:        -  To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin          NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the          hospital.        -  To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg          70/30 mix) and how well they work for the treatment of diabetes when transitioning from          inpatient therapy to outpatient care.   "
227342|NCT00821808|"     This phase I Healthy Volunteer study will evaluate the pressure interface between the devices     (a compression device and Profore®) and the skin, using the PicoPress(TM) pressure transducer     at specified time intervals in three distinct locations on the leg, in both the sitting and     standing position. It will also assess the variability of interface pressure following     application under each test device for each subject over a period of three days (three     separate applications).   "
227343|NCT00821821|"     The objectives of this study are to assess the safety, tolerability and local tolerance, and     to investigate the plasma levels and terminal elimination half life of MCI-186, and to review     the routine clinical and neurological assessments data of MCI-186 in subjects with acute     ischemic stroke.   "
227344|NCT00821834|"     Primary objective:        -  To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower          risk of the safety events of interest in patients with stable angina (SA) or old          myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being          planned.      Secondary objectives:        -  To compare the incidence of adverse events, adverse drug reactions and bleeding events          in patients treated with clopidogrel versus ticlopidine.        -  To compare the incidence of major adverse cardiac events (MACE) and major adverse          cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus          ticlopidine.        -  To evaluate the long-term safety (adverse drug reactions, adverse events, safety events          of interest and bleeding events) of clopidogrel for a total of 52 weeks;        -  To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.   "
227345|NCT00821847|"     Recent progress in antiretroviral therapy has turned HIV infection into a chronic disease.     Patients survival has dramatically improved but complications may occur that need to be     prevented and monitored. As much as 10 % of HIV patients may suffer from chronic kidney     disease, an affection that is not symptomatic until a very late stage secondary to HIV     infection, drugs exposure, hypertension or diabetes. Guidelines have suggested that renal     function should be regularly assessed in HIV patients to perform early diagnosis for chronic     kidney disease and allow initiation of preventive measures aimed at preserving renal     function.      Plasma creatinine dosage is the easiest way to evaluate renal function but glomerular     filtration rate estimation from cockcroft or MDRD formulae is a much better indicator of     renal function. Other markers like cystatin C may be used. None of these markers has been     validated in HIV patients. Therefore our study is aimed at comparing validity of creatinine     clearance estimation with Cockcroft and Gault and MDRD formula and cystatin C compared to the     gold standard measurement of glomerular renal function.   "
227346|NCT00821860|"     RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of     the chest cavity may be effective in treating pleural effusion and cause less damage to     normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is     not yet known which therapy is more effective in treating pleural effusion caused by     malignant mesothelioma.      PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well     it works compared with talc pleurodesis in treating patients with malignant mesothelioma.   "
227347|NCT00821873|"     The main objective of this study is to test the ability of an allograft plug to provide a     successful repair of an osteochondral defect left at the harvest site during OATS procedure.   "
227348|NCT00821886|"     In this phase II trial the investigators propose to evaluate ixabepilone in combination with     carboplatin and trastuzumab as neoadjuvant therapy in locally advanced breast cancer     patients. Patients with early stage, HER2-positive breast cancer will receive six cycles of     neoadjuvant treatment with ixabepilone, carboplatin, and trastuzumab every three weeks prior     to surgery; after surgery, patients will continue treatment with trastuzumab every three     weeks until week 52. Concomitant with the post-operative trastuzumab treatment, patients with     hormone receptor-positive tumors will receive anti-estrogen treatment. Also, after the     completion of chemotherapy, patients may receive radiation treatment at the discretion of     their physician.   "
227349|NCT00821899|"     This project evaluates the effectiveness of the administration of autologous bone marrow     blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After     mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow     blood will be obtained by multifunction in the posterior iliac crest. The material obtained     will be implanted into the pancreas through the magna pancreatic artery after femoral     catheterization.   "
227350|NCT00821912|"     This is an open label, non-randomised, multicentre phase 1-2 study with a fixed dose of     Taxotere in combination with Xeloda which is dose escalated during the first phase of the     study (modified Fibonacci design) and fixed during the second phase.      The primary objective of the phase 1 part is to define the dose recommended for the Phase II     part of the study. The primary objective is to determine the response rate.   "
227351|NCT00821925|"     The purpose of this study is to estimate Osteoporosis' prevalence in France and is a pilot     study in the Department of the Alpes-Maritimes.   "
227352|NCT00821938|"     Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients     with narrow QRS complex and optimized medical treatment but echocardiographic     desynchronization detection as well as the positve increase of the intraoperative     pressureincreasespeed in reverse remodelling and a secondary improvement of functional     parameters   "
227395|NCT00828126|"     The goal of this clinical research study is to learn how often using a positron emission     tomography-computed tomography (PET-CT) scan in addition to a standard computed tomography     (CT) scan will change the surgical plan in patients with metastatic melanoma.   "
227353|NCT00821951|"     This is a dose escalation study that will assess the safety of Vorinostat, a Histone     Deacetylase (HDAC) inhibitor, in combination with palliative radiotherapy in patients with     advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Vorinostat has been approved for     use in patients with cutaneous T-cell lymphomas, but several pre-clinical studies suggest     activity in lung cancer cell lines. Several HDAC inhibitors,including Vorinostat, may enhance     the effect of radiotherapy, and this study will seek to confirm this.   "
227354|NCT00821964|"     This phase II trial is studying the side effects of giving topical imiquimod together with     Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) to see how well it works in     treating patients with advanced breast cancer. Biological therapies, such as imiquimod, may     stimulate the immune system to kill tumor cells. Drugs used in chemotherapy, such as     Abraxane, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving imiquimod together with Abraxane may kill     more tumor cells.   "
227355|NCT00821977|"     This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes     patients receiving vildagliptin as monotherapy.   "
227356|NCT00821990|"     Because well-designed, randomized, controlled clinical trials are lacking in patients with     advanced gastric cancer (AGC), and because randomly allocating patients to treatments that do     not accord with their preferences may influence trial validity, the investigators employed a     patient preference randomized trial design to compare the efficacy of second-line     chemotherapy and best supportive care.   "
227358|NCT00822016|"     The purpose of this study is to establish a listing (database) of patients diagnosed with     lung cancer and treated with best supportive care and standard and investigational     chemotherapy regimens, surgery, and radiation therapy at the UNM CRTC and other NMCCA sites.     The information will be used to determine the results of various treatments for lung cancer     subjects and to find where improvements can be made in safety, effectiveness, supportive     care, treatment that eases tumors without curing them, treatments that cure tumors,     prevention, and follow-up efforts. The database information will be compared to clinical     trial data published in peer-reviewed journals and SEER outcome data. Patients will be     acquired both before and after they are treated for lung cancer.   "
227359|NCT00822029|"     It is a double blind randomized study aiming at estimating the efficiency of oral     bisphosphonates on the decrease of osteoporosis by comparing the evolution of densitometric     values between two groups of children (treatment versus placebo).   "
227360|NCT00822042|"     Hypothesis: systemic therapy with corticosteroid induces morphological changes (e.g., moon     face, buffalo neck) called lipodystrophy (LD). We hypothesize that this LD is associated with     variation of adipocytokines (e.g., adiponectin, leptine, IL6) levels      Primary objective: To show a 50% decrease in adipocytes adiponectin's expression in patients     who developed LD versus those who did not developed LD during the first 3 months of a     systemic therapy with corticosteroids      Secondary objectives: To look for differences in the mRNA expression of 11bHSD1, SREBP1c and     PPARg in fat samples of patients before and after treatment with systemic corticosteroids and     between LD+ and LD-patients To compare the fat morphology before and after treatment with     glucosteroids   "
227361|NCT00822055|"     This study compares the efficacy and tolerability/comfort of brimonidine/timolol and     dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an     investigator masked randomisation process, each subject is allocated to received either     brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an     adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient     returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.   "
227362|NCT00822068|"     The study aims to identify if intensive language training, consisting mainly of     computer-based object naming, together with electrical brain stimulation, will lead to an     improvement of language functions in patients that suffer from language disturbances after a     stroke.   "
227363|NCT00822081|"     This study compares the efficacy and tolerability/comfort of brimonidine/timolol and     dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an     investigator masked randomization process, each subject is allocated to recieve either     brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an     adjuctive to a prostoglandin analogue for a period of 12 weeks. After screening, patient     returns at baseline, Month 1, and Month 3 for ophthalmic evaluations.   "
227364|NCT00822094|"     The study investigates if CPX-351 will be a) more effective than the standard intensive     salvage AML treatment and b) more tolerable than the standard intensive salvage treatment     regimens.      The study compares the investigational product CPX-351 vs the standard intensive salvage     treatment for first relapse AML patients.   "
227365|NCT00822107|"     The purpose of this study is to test the hypothesis that Gitelman syndrome (GS) can be     diagnosed using a simple clinical protocol. GS is an inherited kidney disease that usually     shows up in patients as low blood potassium levels. Currently, no commercial genetic test for     GS exists. Currently, GS is diagnosed based upon clinical findings but this method is not     precise and often not reliable. Thus, in order to develop new treatments specific for GS     patients, a more exact method of diagnosis would be of benefit.      Eligible subjects are men and women ages 21-60 with normal blood pressure who have been     diagnosed with low blood potassium of uncertain cause. Subjects may withdraw at any time.      This study requires 3 visits to OHSU's campus. Study Visit 1 will occur during a normal visit     with the nephrologist. As part of the normal visit, a complete interview, physical exam and     urine and blood samples will be taken. In addition, another blood sample will be taken and     used for genetic analysis. A urine pregnancy test will be administered. A Quality of Life     survey, described below, will be administered. The genetic analysis, urine pregnancy test and     Quality of Life survey are not normal tests for GS. Blood and urine samples, as well as     pregnancy tests will be collected/administered at the Oregon Clinical and Translational     Research Institute (OCTRI).      During the intervention period, subjects will refrain from taking their potassium sparing     medications for 7 days. This period is called the washout period and is needed to ensure that     blood tests during the hydrochlorthiazide (HCTZ, a water pill) (see below), are not     affected by medications. On the 3rd day of the washout period, Study Visit 2 will occur at     the OCTRI. This will require blood to be drawn, to insure that subjects maintain proper blood     levels of potassium and magnesium. Magnesium and potassium supplements will be allowed during     the washout. After review of the blood test results, the investigator may adjust the doses of     these supplements in order to keep subject blood levels of potassium and magnesium as close     to normal as possible. Blood pressure, heart rate and breathing rate will also be checked at     this visit.      Study Visit 3 will occur at the OCTRI and will be devoted to the HCTZ test. During the course     of the HCTZ test, subjects will have an plastic tube (an IV) placed in an arm vein, have     vital signs checked and receive 50mg of HCTZ to take by mouth . Subjects will provide 8 urine     samples and 3 blood samples. The time required for this visit is expected to be 6 hours.      The total time required for subjects to complete the study from Study Visit 1 through     discharge from the OCTRI on Study Visit 3 will not be less than 9 days and subjects should     not expect the total length to exceed three weeks depending on available appointments for     Study Visit 3 at the OCTRI.      The Quality of Life survey is derived from a national research corporation and has been     modified for use in this study. The authors of this survey allow free public use of this     document provided it is properly referenced in any presentation of the study's results.      HCTZ is an FDA approved medication. There are no experimental drugs or devices used in this     study.      The purpose of this study is to develop methods for, and determine the feasibility of,     performing a HCTZ test and genetic analysis for GS at OHSU. There is no statistical analysis     of data, but descriptive characteristics will be entered into an Access database with     password restricted access. Genetic samples will be analyzed using PCR and standard     sequencing techniques. Data and samples will be stored for a maximum of 15 years.   "
227366|NCT00822120|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side     effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F     18-PET/CT imaging, may help doctors predict how patients will respond to treatment.      PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well     it works in assessing response to combination chemotherapy and allow doctors to plan better     additional further treatment in treating patients with stage III or stage IV Hodgkin     lymphoma.   "
227367|NCT00822133|"     Since VAT bears with it severe postopearive pain, and since ketamine has been shown to be an     optimal analgesics adjuvant for postoperative pain, we wish to assess to effects of ketamie     vs. lidocaine if put on the skin in the sites where scopes are interset into the chest for     thoracoscopy.   "
227368|NCT00822146|"     The aim of this research study is the invasive evaluation of CR therapy efficacy in patients     treated with an InSync Sentry device using an external monitoring device to obtain important     cardiac parameters.   "
227412|NCT00829140|"     The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and     food intake in obese and overweight patients.   "
227413|NCT00829153|"     The requirements for haemodialysis are increasing. There is now acceptance that the most     durable AV fistulae are those created from the patients own veins. Use of the radiocephalic     arteriovenous fistula as an autologous vascular access dates back to the 1960's. (Brescia MJ,     Cimino JE. Appel K, Hurwich BJ. Chronic hemodialysis using venipuncture and a surgically     created arteriovenous fistula. N Engl J Med 1966; 275: 1089 - 1092.) Once established, it has     good long term survival and a low complication rate. However, the success rate at creation of     a useable AV fistula are not good. In a meta-analysis published in 2005, the primary failure     rate of a radiocephalic fistula was 15.3% and the primary and secondary patency rates were     62.5% and 66.0% at one year. (Rooijens PPGM, Tordoir JHM, Stijnen T, Burgmans JPJ, Smet AAEA     and Yo TI. Radiocephalic wrist arteriovenous fistula for hemodialysis: meta-analysis     indicates a high primary failure rate. Eur J Vasc Endovasc Surg 2004; 28, 583-589). Reasons     for this are multiple but it appears as though the main determinants are the quality of the     patients veins and the technical skill of the surgeon. Low patency rates are also seen in     females and those with small veins and arteries. Creating an anastomosis between a small vein     and artery is technically challenging. This is traditionally preformed with a continuous     prolene suture. Recently, Medtronic have been marketing the U Clip Anastomotic Device. This     is a self closing devise which could be called a vascular clip. Reported advantages of this     clip include better patency rates and faster operations. However, to our knowledge there is     no randomised evidence to support this with regards to AV fistulas.      The vascular anastomosis originally developed by Alexis Carrel used interrupted sutures. Over     time this was replaced by a continuous suture technique which was felt to be quicker and had     similar patency rates. However, microvascular, paediatric and neurovascular surgeons have     shown that there are advantages to an interrupted technique. (Hattori H, Killen DA, Green JW.     Influence of suture material and technic on patency of anastomosed arteries of less than     1.5mm. Am Surg. 1970; 36: 352 - 354. Cobbett JR. Microvascular surgery. Surg Clin N Am. 1962;     47: 521.). The reasons for the improved patency with interrupted anastomoses are firstly     increased anastomotic compliance and flow rate and secondly elimination of the pursestring     effect and puckering seen with continuous sutures.      In a prospective but non randomised study to compare interrupted U clips with historical     published results, the patency rate of coronary anastomoses was 100% at 6 months using the U     clips compare to a patency rate of 90 -100% in the published series. (Wolf RK, Alderman EL,     Caskey MP et al. Clinical and six month angiographic evaluation of coronary arterial graft     interrupted anastomoses by use of a self closing clip device: a multicentre prospective     clinical trial. J Thorac cardiovasc Surg 2003; 126(1): 168 - 178.)      Reports from single centres have concluded that the U Clips offer the opportunity to create     superior interrupted anastomoses for AV fistula, even in patients who would otherwise be     considered poor candidates for fistula creation. (Ross JR. Creation of native arteriovenous     fistulas with interrupted anastomoses using a self closing clip device - one clinics     experience. Journal of vascular Access 2002; 3: 140 - 146). In this report with small     numbers, the radiocephalic fistulas had an 8 week maturation rate of 93%. Of the 28 patients     having a radiocephalic fistula, 10 had veins of between 1.0 - 1,5mm diameter.      The aim of this pilot study will be to assess if there is a clinical difference in the     maturation rates of autologous AV fistulae when a clipped anastomosis is compared to a     conventional prolene anastomosis.   "
227369|NCT00822159|"     Hip fractures mostly occur in elderly people with low bone strength. Bone strength is     determined by bone mineral density (BMD), bone turnover, microarchitectural and geometrical     properties of the bone. Dual energy x-ray absorptiometry (DXA) is the standard technique to     measure BMD. However, BMD just provides information regarding the quantity of mineral in     bone, which is only one component of bone strength. To date there is no reliable method to     assess bone strength in vivo. Therefore, a method to assess bone strength beyond BMD would     provide additional information regarding the patients' risk of bone related fixation failure     after fracture fixation.      DensiProbe is a new diagnostic device that was developed for intra-operative assessment of     mechanical stability of the bone in the proximal femur. It consists of a drill bit like tool     and an electronic system to measure the peak torque to break-away of trabecular bone in the     femoral head of patients undergoing DHS surgical treatment. In a cadaver study comparing bone     mineral density measured by quantitative computed tomography with bone strength measured by     DensiProbe a high correlation between these two parameters could be shown. In a clinical     pilot study a significant correlation between DensiProbe measurements and BMD measured by DXA     at the femoral neck in patients with hip fractures could be shown. However, no perfect     correlation was expected because DensiProbe measures bone strength, which is only partly     caused by BMD.      Bone related fixation failure, such as secondary loss of reduction, is influenced by bone     strength, bone mineral density, fracture type, fracture reduction and primary positioning of     the implant. The predictive value of DensiProbe measurements for secondary loss of reduction     needs to be investigated. If DensiProbe turned out to be an effective screening tool for     patients with low bone strength that are on higher risk of the aforementioned complications     these patients may in future benefit from alternative treatment methods (e.g. augmentation     techniques) in order to reduce bone related fixation failure.      The primary aim of the present study is to investigate if bone strength measured by     DensiProbeTM Hip (DensiProbe) is an independent factor to predict secondary loss of reduction     (screw migration of 5 mm or more and / or telescoping of 10 mm or more) in patients with hip     fractures after fracture fixation with DHS.   "
227370|NCT00822172|"     The purpose of this study is to see how safe and effective L carnitine taken with cilostazol     is compared to placebo taken with cilostazol for people with intermittent claudication. A     second purpose of the study is to see if L-carnitine is absorbed into the blood stream.   "
227371|NCT00822185|"     This trial is conducted in Japan. The aim of this trial is to assess the safety and     tolerability of activated recombinant human coagulation factor VII analogue (NN1731,     vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the     pharmacokinetics of NN1731 will be examined   "
227377|NCT00822263|"     The administration of N-acetyl-cysteine (an anti-oxidant) for seven days along with     observation will result in improved hearing and balance function in individuals who     demonstrate these disorders after blast exposure when compared to a placebo medicine and     observation at the seven day time point.   "
227378|NCT00822276|"     Staphylococcus aureus (S.aureus) is a bacterium that causes many painful skin and soft tissue     conditions, such as scalded-skin syndrome, boils, or impetigo. Serious cases may result in     deadly complications but S.aureus can usually be treated successfully with antibiotics. There     are, however, certain strains which cannot be treated with standard antibiotics.     Methicillin-resistant staphylococcus aureus (MRSA) is one such strain.      MRSA is increasingly being seen in both hospital and community settings, making it a serious     public health issue. People with Atopic Dermatitis (AD), particularly those with a history of     Eczema Herpeticum (EH), may be at greater risk for infection by MRSA. The reason for this     higher risk is unknown but may be linked to extended treatment with staphylococcus     antibiotics in addition to the absence of certain proteins on their skin, which have immune     function. The purpose of this study is to determine the reasons for MRSA infection in AD     participants with and without a history of EH.   "
227379|NCT00822289|"     Because of the high iodine uptake in the stomach, radioactive iodine treatment for thyroid     diseases (cancer or hyperthyroidism) or radioactive iodine administered for thyroid scan may     be able to eradicate H.pylori infection from the stomach of patients infected with H.pylori.      Also to test the hypothesis that CagA virulent strains of H.pylori are more common in     patients with thyroid cancer than with other thyroid diseases.   "
227380|NCT00822302|"     The plasma concentration of high-density lipoprotein (HDL) can have anti-inflammatory,     anti-oxidative and anti-thrombotic effects in addition to being able to remove cholesterol     from peripheral tissues for secretion via the liver.      The investigators hypothesise that elevation of plasma HDLs will reduce the inflammatory     response following removal of unstable atherosclerotic plaques in the carotid artery. Such     plaques can cause strokes and there is great benefit from early surgical removal, however     such surgical procedures involve significant risks to the patient.      The investigators propose infusing HDL into patients prior to removal of their unstable     carotid plaque and measuring the changes in inflammatory responses in comparison to a similar     placebo controlled group of patients.   "
227381|NCT00822315|"     Raltegravir is a potent antiretroviral agent that could be used as an alternative to     efavirenz in HIV-1 infected patients with tuberculosis. However due to pharmacokinetic     interactions, the optimal dose of raltegravir to be used in combination with rifampin is     currently unknown.      This phase II open-label randomized multicenter trial is designed to estimate the antiviral     efficacy of two doses of raltegravir and one dose of efavirenz at week 24, in HIV-1 naive     patients co-infected with active tuberculosis (TB) treated with rifampin.   "
227482|NCT00830050|"     The study hypothesis is that the relief of pain in patients with osteoarthritis in the hand     can be detected by a form of brain scanning that detects which parts of the brain are     activated when pain is felt.   "
227483|NCT00830063|"     The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared     with naproxen and placebo in patients with osteoarthritis.   "
244208|NCT01055561|"     The purpose of the study is to evaluate the safety and tolerability of acupuncture for     patients with BPSD & healthy volunteers.   "
227382|NCT00822328|"     Fermented milk is a popular drink. Recent studies revealed that some fermented milk     containing some strains of lactic acid bacteria have health-promoting effects through     improvement of the intestinal microflora and modulation of the immune system. Lactobacillus     casei strain Shirota (LcS) is a probiotic bacterium used in the production of fermented milk     products and lactic acid bacteria preparations. LcS has been shown to modify allergen-induced     immune responses in allergic rhinitis, altering fermentation patterns in the small bowel,     prevention of recurrent urinary tract infections in women. Yakult®300 is a fermented milk     containing at least 3x10^10 live LcS cells per 100 ml bottle. This study aimed to evaluate     the effects of a fermented milk drink containing Lactobacillus casei strain Shirota on the     human intestinal microflora.   "
227383|NCT00822341|"     TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model,     this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy     subjects.   "
227384|NCT00822354|"     The investigators propose that tadalafil will increase digital blood flow and improve the     symptoms and signs of secondary Raynaud's phenomenon.   "
227385|NCT00822367|"     The purpose of the study is to determine which of the commonly used meal supplements is the     best product for patients with DM. This is important because meal supplements are becoming     more popular as meal replacements in the United States. Peak blood sugar occurs about 2 hours     later after a meal. Therefore, the best product would be the one that produces a smallest     rise in blood sugar.   "
227386|NCT00822380|"     Anemia continues to be a major public health problem in many regions of the world and it is     still not clear which strategy is more effective in children population in terms of adherence     and efficacy. The objective was to evaluate the efficacy and acceptance of several strategies     that have been recently recommended to treat anemia on anemic children (6 to 43 mo):Iron     supplement, iron+folic acid supplement, a multiple micronutrients supplement a micronutrient     fortified complementary food in the form of porridge powder or zinc+iron+ascorbic acid     fortified water.   "
227387|NCT00828022|"     The objectives of the study are to assess the efficacy and safety of live, attenuated measles     vaccine as consolidation therapy in patients with measles-positive, non-small cell lung     cancer with locally-advanced (stage 3B with pleural effusion) or metastatic (stage 4) tumors     in remission.   "
227388|NCT00828035|"     Light Endoscopic Robot evaluation in abdominal and urological laparoscopic surgery : surgery     with surgeon and robot (REL group = new treatment) versus surgery with surgeon and assistant     (AO group - standard treatment)      Primary outcome measure : Number of useful hands (light endoscopic robot = one useful     mechanical hand)   "
227403|NCT00828230|"     To proof the superiority of an 8-week rectal treatment with once-daily 2 mg budesonide versus     placebo for the prevention of acute radiation proctitis, and to evaluate the occurrence of     chronic radiation proctitis 1 year after start of radiation therapy.   "
227389|NCT00828048|"     Intraductal papillary mucinous neoplasms of the pancreas (IPMN) are increasingly recognized     in clinical practice. They represent a unique clinicopathologic entity that is characterized     by mucin production, cystic dilation of the pancreatic ducts, and intraductal papillary     growth. The World Health Organization recognized IPMN as a distinct clinical entity in 1996.     Recent literature suggests that up to 45% of IPMN are malignant and should be resected;     however these data are based on larger, primarily symptomatic lesions. Several studies have     been published in the recent literature reporting single-center experience with IPMN     resections and observations with small numbers of patients. The natural history of these     lesions and risk of malignancy is still vague. Consensus guidelines for management of IPMN     were published in 2006, but noted the limited knowledge available in six areas: definition     and classification, preoperative evaluation, indication for resection, method of resection,     histological data on frozen section/positive margins and specimen processing, and finally,     method of follow-up. Speaking to this need, we propose an international registry for     multi-center collaboration in the above areas of need in IPMN research and clinical     management. This will be through a centralized, web-based registry with data entered by each     center in a de-identified way to protect confidentiality.      The data collected from the IRB approved retrospective chart review IRB# 07-007202 will be     incorporated into this data base. Any patients that participate in the prospective study will     be consented with HIPPA consent prior to collection of data.   "
227390|NCT00828061|"     This study will investigate whether changes in inflammatory mediators produced by the nose     after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel     drugs for the treatment of allergic asthma.   "
227391|NCT00828074|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving sorafenib together with vinorelbine may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib when     given together with vinorelbine and to see how well they work in treating women with stage IV     breast cancer.   "
227392|NCT00828087|"     This study is a prospective, randomized controlled, single blind, two-arm, multi center     clinical evaluation. A total of 1500 patients will be enrolled in the study.      Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug     eluting stent arm. The objective of this study is to assess the safety and performance of the     Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable     stent in the setting of primary percutaneous coronary intervention for treatment of patients     presenting with ST-segment elevation myocardial infarction.   "
227393|NCT00828100|"     The primary objective of this study is to compare the performance of the investigational     fluid Rapid Influenza Test and the BinaxNOW® Influenza A & B Test in detecting influenza type     A and influenza type B.   "
227394|NCT00828113|"     This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy     in conjunction with individual counseling for smoking cessation. Adult volunteers in     generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of     open-label varenicline therapy. At 12 weeks after their target quit date, they will be     assigned in a random, double-blind manner to either 40 additional weeks of varenicline or     placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for     the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks     post-treatment.   "
227484|NCT00830076|"     This study will assess the effects of sitagliptin and metformin alone and after     co-administration on incretin hormone concentrations in patients with Type 2 diabetes.   "
227396|NCT00828139|"     This randomized phase II trial is studying topotecan to see how well it works when given with     or without aflibercept in treating patients with extensive-stage small cell lung cancer.     Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Combinations of     biological substances in aflibercept may be able to carry tumor-killing substances directly     to small cell lung cancer cells. Aflibercept may also stop the growth of small cell lung     cancer by blocking blood flow to the tumor. It is not yet known whether topotecan is more     effective with or without aflibercept in treating patients with small cell lung cancer.   "
227397|NCT00828152|"     Hypochondriasis (health anxiety) is common, has many negative consequences for the afflicted     individual and is associated with high societal costs. Cognitive Behavioural Therapy (CBT)     has proven to be effective when administered in live-sessions. The aim of this study is to     investigate whether CBT remains effective when administered via a self-help programme on the     Internet.   "
227398|NCT00828165|"     This is a Phase 1 study, involving a 1-day dosing period (up to 3 dosing periods per     subject), designed to test the safety of investigational study drug ARRY-300 in healthy     subjects. Approximately 12 healthy subjects from the US will be enrolled in this study.   "
227399|NCT00828178|"     The investigators hypothesize that low-dose dietary supplementation with omega-3 fish oil     will improve disease activity and endothelial function in Systemic Lupus Erythematosus (SLE)     patients.   "
227400|NCT00828191|"     Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy     and tolerability of a new progesterone formulation to be used for luteal support in IVF     (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone     tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.   "
227401|NCT00828204|"     The primary objective of the study was to evaluate the safe and effective use of the     single-use autoinjector for the intramuscular (IM) delivery of liquid Avonex® (interferon     beta-1a) in participants with multiple sclerosis (MS).   "
227402|NCT00828217|"     The aim of this study is to assess the efficacy of adapted physical activity intervention on     health-related quality of life and satisfaction with care in hospitalized children and     adolescents.      This is a randomized controlled study. The hypothesis is that children practicing adapted     physical activity during their hospitalization present a higher health-related quality of     life and satisfaction with care than those who do not.   "
249297|NCT01119131|"     A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls,     strength, and cognition in persons with Parkinson's disease.   "
227404|NCT00828243|"     Inherited deficiencies in any one of 3 genes (surfactant protein B, surfactant protein C, and     ATP-binding cassette transporter A3) can cause neonatal respiratory distress syndrome by     disrupting metabolism of the pulmonary surfactant. The investigators will use state of the     art methods to link specific changes in the genetic code of each of these genes with     disruption of discrete steps in the metabolism of the pulmonary surfactant in human newborn     infants. These studies will lead to improved diagnostic capabilities and suggest novel     strategies to correct surfactant deficiency in newborn infants.   "
227405|NCT00828256|"     Arthroscopic repair has become the preferable surgical technique to treat rotator cuff tears     in the last decade. Many researches demonstrate equal and even superior outcome with this     surgical technique, while others show opposite results.      The aim of this study is to estimate the anatomic and functional results of the arthroscopic     repair among the patients of the orthopedic department at the Soroka University Medical     Center, in order to check the investigators hypothesis that indeed - the arthroscopic repair     of the rotator cuff is the better surgical technique.      Methods: study population - 80 patients who had had an arthroscopic repair of the rotator     cuff between the years 2005-2008 at the SUMC.      Inclusion criteria: age over 18 years. arthroscopic rotator cuff repair. date of operation     not before 2005.      Study design:        1. Data base Collection.        2. Inviting the patients for physical examination + ultrasound examination of the operated          shoulder + filling out questionnaires (SF36, CONSTANT SCORE)        3. Statistical analysis        4. Publication   "
227406|NCT00828269|"     The purpose of this study is to evaluate the quality of the RNA and the reproducibility of     gene expression profiling from liver tissue samples obtained by fine needle aspiration.   "
227407|NCT00828282|"     The primary aim of this trial is to generate a preliminary analysis of this novel therapeutic     approach and laboratory studies for patients with recurrent or refractory CLL. Further, this     pilot trial will demonstrate the feasibility of the translational science methods proposed     for this new collaboration of investigators. The investigators hypothesize that patients with     relapsed CLL are recruitable to this study, that the methods for measuring simvastatin     concentration and target protein translation are feasible, and that the investigators can     efficiently apply the laboratory research methods to patient blood samples before and after     patients have taken the study medication.   "
227408|NCT00828295|"     The objective of the study is to assess the safety and efficacy of two doses of IV     palonosetron each administered as a single dose for the prevention of postoperative nausea     and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years     inclusive undergoing surgical procedures requiring general endotracheal inhalation     anesthesia.   "
227409|NCT00828308|"     Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.      Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)   "
227410|NCT00828321|"     The objective of this study is to compare the rate and extent of absorption of ramipril 10 mg     capsule (test) versus Altace® (reference), administered as 1 x 10 mg capsule under fasting     conditions.   "
227411|NCT00828347|"     There are still no established protocols for maintenance therapy with intravenous or oral     vitamin D preparations after the iPTH target has been achieved.      Therefore, the present study compared the efficacy of two maintenance therapy protocols,     i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0     ug/day (higher-dose group) or at a dose of 0.25 ug/day (lower-dose group), in patients with     secondary hyperparathyroidism who responded to initial maxacalcitol therapy, resulting in the     control of iPTH to < 150 pg/mL.   "
227414|NCT00829166|"     This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial     designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of     capecitabine + lapatinib in participants with human epidermal growth factor receptor 2     (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated     until disease progression (PD), unmanageable toxicity, or study termination. Once disease     progression is reported, all participants will be followed for survival every 3 months until     death, loss to follow-up, withdrawal of consent, or study termination.   "
227415|NCT00829179|"     A single center pilot study to determine the protective effects of RhuMAB-E25 on airway     physiology and biology in allergic asthmatics that undergo bronchoprovocation with     methacholine.      The primary study objective determines the protective impact of RhuMAB-E25 on airway     inflammation as reflected in exhaled nitric oxide (NO) levels in allergic asthmatics.      The secondary objective determines the protective effect of rhuMAB E25 against airway     bronchoconstriction as reflected in the Provocative Concentration of methacholine to cause a     20% fall in FEV1(PC20) with methacholine challenge testing.   "
227416|NCT00829192|"     The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in     reducing the number of actinic keratoses and squamous cell carcinomas developing in immune     compromised organ transplant recipients, who are at particularly high risk, over a 24 month     test period.      The number of lesions formed on the head, hands and forarms will be monitored over this 24     month test period.   "
227417|NCT00829205|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cancer cell-killing substances to them. Drugs used in     chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Se-methyl-seleno-l-cysteine may help reduce the side effects of chemotherapy.      PURPOSE: This phase I/II trial is studying the side effects and best dose of     Se-methyl-seleno-l-cysteine when given together with rituximab, ifosfamide, carboplatin, and     etoposide and to see how well it works in treating patients with diffuse large B-cell     lymphoma that has relapsed or not responded to treatment.   "
227432|NCT00829400|"     The purpose of this study is to determine whether augmenting work services with cognitive     remediation can improve vocational outcomes for psychiatrically disabled participants in VA     work services.   "
227433|NCT00829413|"     The purpose of this study is to demonstrate the Sensitivity and Specificity of     SonoVue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the     characterization of benign versus malignant FLLs using final diagnosis based on histology or     combined imaging (CE-CT and/or CE MRI)/clinical data as truth standard.   "
227418|NCT00829218|"     Objective: Randomized, double blind, placebo-controlled, crossover, clinical trial to examine     the effects of the food additive glutamate (in the form of MSG) on IBS and fibromyalgia.      Setting and Subjects: The Fibromyalgia Research Database at OHSU will be utilized to identify     and recruit fibromyalgia patients who also have IBS to OHSU study centers.      Intervention: Approximately 60 male and female subjects aged 18-75 will be placed on a     1-month glutamate-free elimination diet. Those that respond positively to the diet (we are     estimating 30-40 subjects), will then be randomized to receive either a citrus drink     containing 5 grams of MSG; or placebo (the citrus drink alone)on three consecutive days one     week apart.      The investigators are hypothesizing that those who react positively to the elimination diet     will have symptom occurrence statistically more frequently when given the glutamate     challenge, than when given placebo.   "
227419|NCT00829231|"     This study is to find out how the subject's body processes and reacts to the study drug, and     to find out how long it remains in the subjects system after one dose. Subjects with varying     degrees of liver function are being asked to participate in this study. Study results from     subjects with normal liver function will be compared with study results from subjects with     impaired liver function.   "
227420|NCT00829244|"     The overall objective of this trial is to compare the ovarian response in assisted     reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in     recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment'     (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per     day.   "
227421|NCT00829257|"     The purpose of this study is to establish whether addition of extra-fine particle steroid     inhalers achieve additional suppression of small airways inflammation when added to     'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.   "
227422|NCT00829270|"     Mitochondrial diseases are the most frequent metabolic diseases (2.5 persons among 10 000)     and are clinically heterogeneous making diagnosis particularly challenging for clinicians.      Molecular analysis of mitochondrial DNA (mtDNA) is a critical step in diagnosis and genetic     counselling of respiratory chain defects. DNA sequencing remains the gold standard but it is     time-consuming and fails to detect mutations that may be present at a low heteroplasmic level     (20% or below); therefore the diagnosis is yet based on the detection of a few number of     pathogenic mutations.      The present study aims to evaluate the benefit and the cost of a diagnosis strategy based on     the combined use of 2 techniques named Surveyor Nuclease and Mitochip. Surveyor nuclease     is a mismatch-specific DNA endonuclease that will be used for screening the entire mtDNA in     order to identify heteroplasmic mutations. In absence of any identified mutation, another     technique based on the use an oligonucleotide sequencing microarray (MitoChip) will be     performed for the identification of homoplasmic mutations. Mitochip is an array-based     sequencing platform for rapid and high-throughput analysis of mitochondrial DNA.      The economical study will compare the cost of these techniques to the standard diagnosis     method in term of direct and indirect costs   "
227423|NCT00829283|"     This controlled study will test the effectiveness of a stepped-care approach to a standard     behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The     major question is whether the stepped-care approach, which begins with behavioral weight loss     and then follows a decision tree for additional interventions based on early treatment     response is superior to standard behavioral treatment.   "
227424|NCT00829296|"     The study is being done to see if a drug shown to lower the risk of heart failure is also     effective in reducing the stiffness of the arteries.   "
227425|NCT00829309|"     This study compared the relative bioavailability (rate and extent of absorption) of     Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd. with that of     Pravachol® Tablets 80 mg by Bristol-Myers Squibb Company following a single oral dose (1 x 80     mg tablet)in healthy adult male subjects administered under non-fasting conditions.   "
227589|NCT00831454|"     The aim of this study was to retrospectively evaluate associations between EGFR and AKT     DNA-polymorphisms involved in transcriptional regulation and overall survival in NSCLC     patients treated with EGFR-TKIs.   "
227426|NCT00829322|"     Fatigue is a persistent, subjective sense of tiredness, which interferes with a person's     usual ability to function. It is believed to be both the most common and the most distressing     symptom experienced by those with cancer. Despite the magnitude of the problem, there has     been inadequate research into the management of cancer-related fatigue.      Central nervous system (CNS) stimulants are the only class of drug established as being     directly effective in relieving fatigue. Traditional stimulants, such as methylphenidate     (Ritalin), can cause side-effects such as difficulty sleeping at night and anxiety. Modafinil     is a relatively new stimulant with few side-effects. There is increasing evidence that     modafinil can reduce fatigue in healthy individuals and patients with chronic, non-cancer     conditions. No good quality studies have been published evaluating modafinil in patients with     cancer, despite multiple calls for such research to be undertaken.      The investigators have completed a small study to determine the feasibility of undertaking a     larger, high quality study to assess the effect of modafinil on fatigue in patients with lung     cancer. Modafinil appeared to improve fatigue rapidly and was not associated with serious     side-effects. Ten of the fifteen patients who completed the study chose to continue modafinil     long-term. However, the study was too small for definite conclusions to be drawn.      This larger, definitive study, funded by a National Cancer Research Institute research award,     will establish more clearly whether modafinil can improve fatigue in patients with lung     cancer. Two hundred and six patients will be recruited from a number of sites across the UK.     Half of the patients will take modafinil, and the other half will take a 'dummy' tablet every     day for a month. The fatigue levels of the two groups will be compared. Confirmation that     modafinil can relieve cancer-related fatigue could have a highly significant impact on the     quality of life of the very large number of patients suffering from this common and     distressing symptom.   "
227427|NCT00829335|"     Anatomical resection is the gold standard approach for liver resection in patients with HCC.     A new method for that by means of IOUS-guided finger compression has been devised.   "
227428|NCT00829348|"     The objective of the study is to determine whether short text massages could be used     successfully as a compliance aid and improve clinical outcomes in long term lipid lowering     therapy.   "
227429|NCT00829361|"     The STARR network registry consists of a 4 spoke 1 hub system. Which will consist of     prospective collection, recording, and regular analysis of telestroke patient consultation     and care data for the purpose of quality measure assessment and improvement and benchmarking     against other national and international telestroke programs.   "
227430|NCT00829374|"     The purpose of this study is to determine if Dimebon is safe and effective in patients with     mild to moderate Alzheimer's disease on Donepezil.   "
227431|NCT00829387|"     The purpose of this study is to evaluate the efficacy of a brief psychological intervention,     cognitive-behavior therapy, for the management of persistent pain associated with diabetic     peripheral neuropathic pain.   "
227434|NCT00829426|"     This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg     Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA     with that of 3 mg XANAX XR® Tablets by Pharmacia & Upjohn Company following a single oral     dose (1 x 3 mg extended release tablet) in healthy adult subjects administered under fasting     conditions.   "
227435|NCT00829439|"     This study is designed to determine the highest dose of levodopa/carbidopa that can be     tolerated without any serious side effects by children with Angelman syndrome.      It has been hypothesized that levodopa may lead to an improvement in the neurodevelopment and     abnormal movements (e.g. tremors) in children with Angelman syndrome.      Data from this study will be used to design a phase II trial to determine the efficacy of     levodopa in treating children with Angelman syndrome.   "
227436|NCT00829452|"     The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg     capsule (test) versus Altace® (reference) administered as the content of 1 x 10 mg capsule     mixed with applesauce under fasting conditions.   "
227437|NCT00829465|"     Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more     than 28%. After diagnosis, the average survival rate of patient is less than 50% in 6 month,     less than 24% in 1 year and 5% in 5 year. The TACE treatment, under the theoretical basis of     blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in     terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of     life. However, its overall effect is not yet satisfactory. As a result, concerning the     research of drug for liver cancer and improving the overall efficacy of the treatment of     liver cancer has a very real and important clinical significance and social value. Licartin     (Iodine-131-Labeled Metuximab) injection is a antibody drug with new target and the only drug     that China own the intellectual property rights. It has specific high affinity with     HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue,     owning high-dose concentration and releasing β particles to liver cancer cells to and kill     cancer cells.      The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use     the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular     carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival     rate between different treatment group.   "
227438|NCT00829478|"     The primary aim of this proposal is to determine the effectiveness of a decision support tool     on improving the process of shared decision-making for treatment on nonvalvular atrial     fibrillation (NVAF) compared to receipt of usual care.   "
227439|NCT00829491|"     The objective of the Denver Health CVD Prevention Program is to assess the effectiveness of     developing an enhanced cardiovascular disease prevention program in a community health care     setting.   "
227440|NCT00829504|"     The objective of this study was to compare the relative bioavailability of the test     formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of     Requip® (Manufactured by SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under     fasting conditions in healthy, non-smoking, adult subjects.   "
227526|NCT00830622|"     A clinical study to evaluate the use of cell phones to support drug adherence and follow-up     of patients taking antiretroviral therapy (ART) for treatment of HIV. The intervention     involves health-care providers sending regular short-message-service (SMS) text messages to     patients and following up their responses. The hypothesis is that the cell phone intervention     will improve ART adherence and health outcomes compared with the current standard of care.   "
227441|NCT00829517|"     This project seeks to demonstrate that computer kiosks in a clinic waiting room can improve     access to hormonal contraception and screening for sexually transmitted infections. The study     will be a randomized controlled trial which will evaluate the use of a computer kiosk module     to compare the proportion of women of reproductive age who receive a prescription for     hormonal contraception when computer-assisted provision of hormonal contraception is offered     (intervention) to encounters when the study clinic provides standard contraceptive care     (control). Subjects will be contacted approximately 3 months (range 2-4 months) after the     clinic visit to complete a follow-up phone interview. The study population will include     English and Spanish-speaking women ages 18-45 who seek care at this clinic. Our hypothesis is     that computer-assisted provision of hormonal contraception (intervention)will increase the     proportion of women of reproductive age who receive a prescription for hormonal contraception     versus standard contraceptive care(control).   "
227442|NCT00829530|"     The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg     capsule (test) versus Altace® (reference), administered as 1 x 10 mg capsule under fed     conditions.   "
227443|NCT00829543|"     This study is designed to evaluate the efficacy and safety of guide-free sacroiliac joint     (SIJ) injection in refractory sacroiliac pain due to spondyloarthropathies.   "
227444|NCT00829556|"     This study is being conducted to investigate the potential benefits of using a special type     of fluid that can be applied to the skin (Integuseal) in addition to standard surgical skin     preparation in patients undergoing total hip replacement (THA) or total knee replacement     (TKA). Integuseal is supposed to lock down the skin bacteria and reduce skin infection and     other problems. This study will investigate whether Integuseal is effective in reducing     persistent wound drainage when used in addition to standard surgical skin preparation for     total hip arthroplasty (THA) or total knee replacement (TKA).   "
227445|NCT00829569|"     The purpose of this experimental study is to investigate whether an acute lipid infusion     added marine n-3 fatty acids produces effects on insulin sensitivity in subjects with type 2     diabetes, when compared with an acute lipid infusion without marine n-3 fatty acids.     Furthermore other effects on intermediary metabolism are tested for.   "
227446|NCT00829582|"     Title: Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Phase I Study of the     Safety, Tolerability and Pharmacokinetics of a Single Intravenous Dose of ETI-204 (AnthimTM)      Population: This study will determine the safety, tolerability and pharmacokinetics of a     single iv dose of ETI-204 in subjects 18 to 50 years of age. Three cohorts will be studied     sequentially: subjects receiving 120 mg, 240 mg and 360 mg of ETI-204. The study will be     randomized, double-blind, and stratified by gender. Each cohort will contain 15 subjects     (including at least four females), twelve who will receive ETI-204 and three who will receive     placebo.      Study Objectives: To determine the safety, tolerability and pharmacokinetics of ETI-204     following a single intravenous administration.   "
227447|NCT00829595|"     Patients with inflammatory bowel disease (IBD) will be assessed for immunologic response to     pneumococcal vaccination. Patients with IBD meet criteria as outlined by the Centers for     Disease Control (CDC) for pneumococcal vaccination, yet the investigators have found that     pneumococcal vaccination in this population is under-utilized. It is unknown whether or not     IBD or IBD-related medications impact the immune response to this recommended vaccine.      Three groups of 25 patients each will be recruited. The first group will consist of     outpatients with IBD who are receiving infliximab (Remicade TM) while on concommitant     immunosuppressive therapy (with either 6MP, azathioprine, or methotrexate). This group is     intended to represent a common 'heavily immunosuppressed' patient group with IBD.      The second group will consist of patients with IBD seen in our outpatient clinic who are not     on any immune-suppressive medications. These patients meet CDC criteria for vaccination by     virtue of having a chronic medical illness. The third group will consist of healthy     age-matched (to the first group) controls.      After obtaining informed consent, patients will be screened with baseline lab tests including     testing for antibodies against pneumococcus. At the baseline visit, patients will also     undergo a brief medical history, physical examination, and assessment of their IBD disease     activity.      Included patients will then undergo a one-time intramuscular vaccination with 23-valent     polysaccharide pneumococcal vaccine (Pneumovax TM). One month later, subjects will return for     a blood draw to assess for response to pneumococcal vaccination.   "
227448|NCT00829608|"     The purpose of this study is to determine if administration of the HPV quadrivalent vaccine     in patients diagnosed with RRP has a therapeutic effect on their clinical course. More     specifically, does administration of the vaccine decrease the size and number of papillomas,     severity of disease (i.e. hoarseness, inspiratory vs. biphasic stridor, airway obstruction)     using the LCAS and time interval between required surgical debulking will be analyzed.   "
227449|NCT00829621|"     People who have been scheduled for surgery using Bone Morphogenic Protein (called BMP-2) and     an incisional vacuum assisted closure device (called IVAC) will be asked to join this study.      The purpose of this study is to see if using the IVAC device removes BMP-2 from the wound.     BMP-2 is a protein used by the body to increase bone healing, decrease the need for     additional surgery, and reduce infection rates.      The IVAC is a device that involves a foam dressing secured with an adhesive drape to make an     airtight seal over a surgical incision. Tubing runs from the foam dressing to a device that     uses gentle suction to drain fluid out (like a vacuum). The IVAC stays on for 48-72 hours     depending on amount of drainage. The IVAC by itself helps reduce wound swelling and     complications (such as infection).   "
227450|NCT00829634|"     The intent of this study is to see if the rate that the body breaks down l-methamphetamine     (l-MA) could be used as an accurate estimate for the rate that the body breaks down     d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA     is the commonly abused form of methamphetamine.   "
227527|NCT00830635|"     RATIONALE: A multimedia educational program may help patients with newly diagnosed prostate     cancer and breast cancer reduce distress, make informed treatment decisions, and improve     quality of life.      PURPOSE: This randomized clinical trial is studying how well a multimedia educational program     works in patients with early-stage prostate cancer or breast cancer.   "
227590|NCT00831467|"     The purpose of this study is to determine the efficacy and safety of a new vaccine in hormone     refractory prostate cancer   "
227451|NCT00829647|"     Dasatinib and lenalidomide are both prescribed for use in patients with different cancers of     the blood. This study is experimental because neither drug has been approved by the Food and     Drug Administration for the treatment of chronic lymphocytic leukemia. There are few standard     treatments when fludarabine is no longer effective in patients with CLL. Some patients have     received additional combination therapy with fludarabine, Campath, bone marrow transplants or     supportive care. Dasatinib and lenalidomide have been effective in high-risk CLL patients in     other pilot mono therapy studies. The combination of dasatinib and lenalidomide has not been     studied in humans before and this study is designed to test whether this combination is safe     to use.   "
227452|NCT00829660|"     The purpose of this study is to determine whether acarbose therapy can reduce     cardiovascular-related morbidity and mortality in patients with impaired glucose tolerance     (IGT) who have established coronary heart disease (CHD) or acute coronary syndrome (ACS). A     secondary objective of the study is to determine if acarbose therapy can prevent or delay     transition to type 2 diabetes mellitus (T2DM) in this patient population.   "
227453|NCT00829673|"     The objective of this randomized, single-dose, two-way evaluation is to compare the     bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral     dose of the commercially available dexmethylphenidate hydrochloride (Focalin®, Novartis     Pharmaceuticals Corporation) in a test population of 24 adult subjects under fed conditions.   "
227454|NCT00829686|"     Patients will be enrolled in a multi-center study to prospectively evaluate outcome after     treatment for an uncomplicated skin abscess. All patients will receive incision and drainage     and wound cultures. Patients will then be randomized to 1)no antibiotic or 2) bacterium     double strength (DS) (800/160) two tablets per oral (PO) twice a day x 7 days. This is the     dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion     in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the     emergency room (ER) on days 3 and 7 for wound repacking and evaluation. The primary outcome     is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within     30 days of treatment. Patients who are not improving at the following visit will then be     treated with additional antibiotics or admission if needed. Data will be analyzed both by     initial randomization and intention to treat. This serves as the pilot for the full placebo     controlled randomized trial.   "
227455|NCT00829699|"     The purpose of this study is to learn more about why patients with diabetes have increased     heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood     vessel. The proposed protocol will study the separate and combined effects of high glucose     and high fats on certain cardiovascular responses in Type 2 DM.   "
227456|NCT00829712|"     The objective of this randomized, single-dose, two-way evaluation is to compare the     bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral     dose of the commercially available dexmethylphenidate hydrochloride in a test population of     24 adult subjects under fasted conditions.   "
227457|NCT00829725|"     The purpose of this study is to compare between two methods of internal fixation, the 3-4     parallel screws or the Targon FN implant in gardens type 1-2 or Pauwels type 1-2 femoral neck     fractures in terms of the outcomes and complications associated with the treatment of these     fractures.   "
227458|NCT00829738|"     The aim of this study was to evaluate the effect of 14 days treatment with Pantoprazole 40 mg     and 20 mg on gastroesophageal reflux disease (GERD) related symptoms in a large patient     population.   "
227459|NCT00829751|"     The purpose of this study is to more objectively evaluate potential lens-material/care     solution bio-incompatibilities. We will do this by measuring corneal staining and the amount     of fluorescein dye diffusion into the eye.   "
227460|NCT00829764|"     The objective of this single-dose, open-label, randomized, two-period crossover study was to     compare the rate of absorption and oral bioavailability of a test formulation of doxycycline     monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc. and     distributed by TEVA Pharmaceuticals USA to an equivalent oral dose of the commercially     available reference product, Vibramycin Monohydrate® manufactured by Pfizer, Inc. following     an overnight fast of at least 10 hours.   "
227461|NCT00829777|"     The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol     administered to opiate dependent subjects   "
227462|NCT00829790|"     The objective of this study was to compare the rate of absorption and the oral     bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral     suspension manufactured by IVAX Pharmaceuticals, Inc. and distributed by TEVA Pharmaceuticals     USA to an equivalent oral dose of the commercially available reference product, Vibramycin     Monohydrate® manufactured by Pfizer, Inc. Following an overnight fast of at least 10 hours,     subjects consumed a standard high-calorie. high-fat breakfast meal. This standard breakfast     meal began 30 minutes prior to each dose.   "
227463|NCT00829803|"     Establish the range of index values for the SNAP II corresponding to each anesthetic state     studied.   "
227464|NCT00829816|"     The purpose of this study is to evaluate the safety and tolerability of dimebon given to     Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine     plus donepezil.   "
227465|NCT00829829|"     The purpose of this clinical research study was to determine the safety and effectiveness of     an experimental drug called rilonacept in subjects with gout who are beginning allopurinol     treatment for gout. Subjects will participate in this study for approximately 22 weeks.     Rilonacept is being studied for use in preventing allopurinol-induced gout flares.   "
227466|NCT00829842|"     Hospital infections play an important role in the increase of patients' morbimortality and     hospitalization costs, especially in the case of individuals admitted to intensive care units     (ICU) during postoperative heart surgery. Analysis of the epidemiological profile of the     hospital infections in the pediatric-ICU (P-ICU) of Hospital das Clínicas da Faculdade de     Medicina de Ribeirão Preto, University of São Paulo (HCFMRP-USP) demonstrated a 31.1%     incidence of pneumonia (PNM) and a rate of ventilator-associated pneumonia (VAP) of 23.81 per     1000 ventilators-day between March 2004 and February 2005 in the group submitted to cardiac     surgery. Knowledge of the pathophysiology and risk factors associated with this infection     allows for measures aiming at reducing its incidence. The objective of the present study is     to evaluate the effect of oral hygiene with a 0.12% chlorhexidine solution on the incidence     of PNM and PAV in children submitted to cardiac surgery.   "
227467|NCT00829855|"     Acute cardiogenic pulmonary edema (ACPE), one of the most severe forms of acute heart     failure, represents 5% of hospital admissions. One of the most frequent phenomena encountered     during ACPE is hypertensive crisis (hypertensive ACPE) but the mechanisms and causes of     hypertensive ACPE are insufficiently understood. Few studies have evaluated the cardiac     function during hypertensive ACPE, and these studies used only conventional echocardiography     methods. New methods of evaluation of cardiac function in hypertensive ACPE (such as Tissue     Doppler imaging) have not been used.      The objectives of this study are to evaluate presence and role of the following potential     mechanisms of hypertensive ACPE: 1. acute myocardial dysfunction (systolic and diastolic); 2.     silent transient myocardial ischemia; 3. acute mechanical left ventricular dyssynchrony; 4.     dynamic mitral regurgitation; 5. inter-ventricular interaction. Conventional and Tissue     Doppler echocardiography will be used to assess cardiac function.   "
227468|NCT00829868|"     The objective of this study is to compare the relative bioavailability of zaleplon 10 mg     capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg     capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, adult subjects under     non-fasting conditions.   "
227469|NCT00829881|"     This study will determine whether the drug betahistine increases focus and causes side     effects in people with attention deficit hyperactivity disorder.   "
227470|NCT00829894|"     The objective of this study was to compare the rate and extent of absorption of risperidone 1     mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablets under fed     conditions.   "
227471|NCT00829907|"     The purpose of the study is to evaluate the effect of ORM-12741 on receptor occupancy by     positron emission tomography with different doses and plasma concentrations. The     pharmacokinetic profile and safety will also be evaluated.   "
227472|NCT00829920|"     The investigators hypothesize that circulating tumor cells (CTC) will be observed in patients     with muscle-invasive or metastatic bladder cancer and that CTC will become undetectable, at     least transiently, in a fraction of patients after treatment. To investigate this hypothesis,     investigators will assess the levels of CTCs both before and after treatment. The feasibility     and potential value of fluorescent in situ hybridization (FISH) in the CTCs will be assessed.   "
227473|NCT00829933|"     The primary objective of this study is to compare the incidence of hemorrhagic events in     patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus     warfarin potassium (warfarin). The secondary objective includes between-group comparisons     with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers     for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for     the safety evaluation.   "
228432|NCT00845819|"     The purpose of this study is to determine efficacy and toxicity of recombinant human     epidermal growth factor (rhEGF) as a preventive drug of oral mucositis during intensive     chemotherapy with stem cell transplantation in patients with hematologic malignancies.   "
227474|NCT00829946|"     The purpose of the present randomized controlled trial was to determine the effects of a     3-month resistance training program (2 sessions/week) on the functional mobility and muscle     function, muscular dynamic strength, body composition and quality of life of young anorexic     outpatients (≤16 years). The investigators also assessed cardiorespiratory variables of     clinical significance such as peak oxygen uptake.   "
227475|NCT00829959|"     Objectives:      - To evaluate the attitudes and opinions of women undergoing genetic counseling for     hereditary breast and ovarian cancer syndrome, both before and after testing, in regards to     pregnancy and fertility      Hypothesis:      -Factors that will increase the percentage of women endorsing prenatal diagnostic testing     will include a personal history of breast or ovarian cancer, having had a mother or sister     die of breast or ovarian cancer, and testing positive for a BRCA mutation.   "
227476|NCT00829972|"     The investigators aim to evaluate the levels of serum Vitamin D in children having their     tonsils removed and appropriate controls. The investigators hypothesize that children     undergoing tonsil removal will have lower Vit D levels than accepted norms and when compared     to controls. The investigators also hypothesize that Vitamin D deficiency will correlate with     indicators of inflammation such as C-Reactive Protein (CRP) and tonsil size.   "
227477|NCT00829985|"     There is currently no effective way to prevent development of allergic rhinitis (nasal     allergies) and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in     which allergens are placed under the tongue, may be a way to control and possibly prevent     allergic rhinitis and asthma. However, detailed research of this approach is limited. The     purpose of this study is to evaluate the safety and efficacy of a sublingual cockroach     extract given to adults with perennial allergic rhinitis, asthma, or both.   "
227478|NCT00829998|"     The objective of this study was to compare the relative bioavailability of Zaleplon 10 mg     Capsules manufactured by TEVA Pharmaceuticals USA and Sonata® 10 mg Capsules manufactured by     Wyeth Laboratories in healthy, non-smoking adults under fasting conditions.   "
227479|NCT00830011|"     The primary objective of this study is to evaluate the usefulness of cognitive behavioral     therapy (CBT) for the management of painful diabetic neuropathy. Participants will be     randomly assigned to one of two treatment conditions: CBT plus standard medical care or     standard medical care alone. CBT will be offered in ten, ninety-minute group sessions and     will be provided by a psychologist with experience in the management of both diabetes and     chronic pain. CBT will involve teaching and encouraging practice of adaptive pain coping     skills such as relaxation skills, activity pacing, and positive self-statements, among     others. This study will allow us to determine which treatment is superior in terms of     improvements in pain management, functioning and overall quality of life.   "
227480|NCT00830024|"     This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg     Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA     with that of 3 mg XANAX XR® Tablets by Pharmacia & Upjohn Company following a single oral     dose (1 x 3 mg extended release tablet) in healthy adult subjects administered under     non-fasting conditions.   "
227481|NCT00830037|"     The long-term goal is to assess the fall in kidney function measured by glomerular filtration     rate (GFR) when patients with chronic kidney disease (CKD) are exposed to intravenous iron     (IVIR). We hypothesize that in subjects with mild to moderate CKD, infusion of intravenous     iron (IVIR), will generate oxidative stress and cause an inflammatory response that will be     associated with a more rapid decline in glomerular filtration rate (GFR) compared to oral     iron.   "
227485|NCT00830089|"     Keyhole surgery for bowel disease has brought great benefits, enabling patients to recover     quicker from surgery and so return to normal activities. Although keyhole surgery reduces     pain following abdominal surgery, it still causes enough pain to require strong pain killing     medications such as morphine-like drugs which, although good pain killers, can have a     detrimental effect on the recovery of bowel function, leading to feelings of nausea and     vomiting and ultimately delaying recovery. These side-effects can reduce the potential     benefits from keyhole surgery and our fast-track recovery programmes.      The aim of this project is to assess the effectiveness of a new method of pain control after     keyhole bowel surgery. The study involves the injection of local anaesthetic into the     abdominal muscles once the patient is anaesthetised. Although use of local anaesthetic is     common practice, we are looking at a new technique of injecting it called a transversus     abdominis plane (or TAP) block. This technique will attempt to block the pain nerves to the     abdomen prior to the operation beginning. We plan to investigate whether this new technique     will reduce the amount of pain following keyhole bowel surgery. If successful, it might be     used to further enhance people's recovery from bowel surgery.   "
227486|NCT00830102|"     The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo     or fluticasone and formoterol administered concurrently or alone in asthma patients.   "
227487|NCT00830115|"     The aim of the study was to evaluate the effect of pantoprazole on sleep disorders in     patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux     disease). The prevalence and intensity of the sleep disorders were evaluated by a     standardized questionnaire. The study was expected to provide further data on safety and     tolerability of pantoprazole.   "
227488|NCT00830128|"     This study will assess the safety and efficacy of the long-term use of pregabalin at doses up     to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study     A0081208 (NCT00830167).   "
227513|NCT00830453|"     The purpose of this study is to discover the feasibility of conducting clinical research in     individuals with chronic sequelae following brain injury who are given hyperbaric oxygen.     This study will also look at the outcome of individuals with a chronic stable brain injury     due to trauma, anoxia (lack of oxygen to the brain), or stroke, who are given hyperbaric     oxygen. Outcome measures testing cognitive (memory, etc.) and functional (balance, strength,     etc.) measures will be performed before the hyperbaric sessions, immediately following them,     and 6 months later. The subject will receive 60 hyperbaric sessions, 60 minutes in the     chamber, to a pressure of 1.5 ATA, once daily, Monday through Friday.   "
227948|NCT00836082|"     To determine if PF-04457845 at doses of 0.5mg, 1mg, 4mg, and 8 mg given once daily for 14     days will be safe and well tolerated in healthy volunteers. To determine the effect on food     on PF-04457845 pharmacokinetics and safety following administration of single doses of 4mg     and 8mg.   "
227489|NCT00830141|"     Obesity, now a global epidemic, is a leading cause of illness and mortality in the developed     world. To better understand the pathophysiological mechanisms that underlie weight disorders,     increasing attention is being paid to central regulatory elements in energy homeostasis,     including food intake and energy expenditure. The human hormone ghrelin is secreted as a     preprohormone (preproghrelin), from which two hormones with antagonistic effects are derived:     ghrelin, which has orexigenic effects and obestatin, which has anorexigenic effects.     Ghrelin's actions are mediated by GH secretagogue receptor (GHSR). Ghrelin synthesis occurs     predominantly in epithelial cells of the fundus of the stomach. . As the ligand for GHSR,     ghrelin stimulates secretion of GH. In both rodents and humans, ghrelin regulates hunger     though its action on hypothalamic feeding centers. Other effects of ghrelin include     stimulating gastric emptying, positive effects on cardiovascular function, increasing     intestinal peristalsis, and positive exocrine and paracrine pancreatic secretion. Despite its     important physiological role, its precise regulatory mechanisms remain ambiguous. Thus, it     has been suggested that mutations in ghrelin and its receptor will present clinically with     obesity, eating disorders or growth disturbances. To date, only four different mutations have     been reported in GHSR and no mutations have been found in the ghrelin gene.      Working hypothesis and aims: We hypothesize that mutations in ghrelin or in its receptor,     GHSR, affect appetite regulation and cause growth and eating disorders.   "
227490|NCT00830154|"     A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy,     safety and tolerability of pagoclone for adults with stuttering.   "
227491|NCT00830167|"     This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the     efficacy and safety of pregabalin in patients with fibromyalgia.   "
227492|NCT00830180|"     To evaluate the safety and efficacy of anti-NGF AB in cancer patients with pain due to bone     metastases who participated in the double-blind Study A4091003 and who wish to receive     open-label therapy.   "
227493|NCT00830193|"     Critically ill patients frequently undergo contrast enhanced computed tomography (CT) to     establish diagnoses and direct management. Contrast agents can disturb kidney function and     result in kidney dysfunction. The investigators investigated the effects of high dose     N-acetylcysteine (NAC) or placebo, in addition to hydration, in preventing kidney dysfunction     following contrast enhanced CT) in critically ill adults in the intensive care units of two     teaching hospitals.   "
227494|NCT00830206|"     The study will compare the relative bioavailability (rate and extent of absorption) of 200     mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.;     distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX®.   "
227495|NCT00830219|"     The purpose of this study is to compare relative bioavailability of the test formulation of     ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA     Pharmaceuticals USA) with the already approved formulation REQUIP® (ropinirole hydrochloride)     0.25 mg tablets (GlaxoSmithKline) under fed conditions in healthy, adult subjects.   "
227496|NCT00830232|"     The goal of the proposed study is to contrast the relative efficacy of closed-cell stents     versus open-cell stents in preventing periprocedural cerebral embolization in high-risk     patients with symptomatic and asymptomatic extracranial carotid stenosis undergoing carotid     artery stenting (CAS).   "
227497|NCT00830245|"     To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with     leptomeningeal carcinomatosis   "
227498|NCT00830258|"     The objective of this study is to evaluate the comparative bioavailability between     pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80     mg tablets (Bristol Myers Squibb, USA), after a single-dose in healthy subjects under fasting     conditions.   "
227499|NCT00830271|"     This is a randomised pilot study comparing conventional sutures (Vicryl and Monocryl) with     antiseptic coated equivalents (Vicryl plus andf Monocryl plus) in elective breast surgery.   "
227528|NCT00830648|"     The objective of the present study is to assess and document the safety of a second dose of     Varicella Biken vaccine administered at 4 to 6 years of age in healthy children having     previously received a first dose of Varicella Biken vaccine.      All subjects will receive a second dose of Varicella vaccine (Varicella Biken) at 4 to 6     years of age.      The expected total duration of follow-up (first visit to last visit) for each subject will be     one month.   "
227500|NCT00830284|"     Lung units which participate in gas exchange are known as 'recruited' lung. Patients with     lung injury suffer from a proportion of units which do not participate in gas exchange (i.e.     the derecruited state), which results in impaired gas exchange and induces an inflammatory     cascade. Currently, there is no clinical practice guideline in our intensive care unit     regarding lung recruitment strategies for children with lung injury. While many studies have     demonstrated efficacy (ability to open the lung) and safety of recruitment maneuvers in     adults, no such studies have been performed in children.      The primary purpose of this study is therefore to demonstrate the safety and efficacy of a     recruitment protocol designed to maximally recruit collapsed lung in children with acute lung     injury. Each study patient will follow a recruitment protocol (see Appendix 2). Two     'controls' will be utilized in this study: baseline ventilation (no recruitment maneuver) and     the open lung approach (a sustained inflation followed by increased PEEP). Efficacy will be     defined as an improvement in lung volume (as measured by nitrogen washout and electrical     impedance tomography), and by an improvement in measured arterial partial pressure of oxygen.     Safety will be defined as the incidence of barotrauma and hemodynamic consequences which     occur during the protocol.      A secondary purpose of this study will be to further validate electrical impedance tomography     (EIT) as a non-invasive tool describing the lung parenchyma by comparing it to an accepted     standard method of measuring lung volumes, the multiple breath nitrogen washout technique.     Validation of EIT would allow clinicians to have a non-invasive image of a patient's lungs     without the risks imposed by radiography.      The information we learn will be instrumental in defining an optimal strategy for lung     recruitment in children with lung injury.   "
227514|NCT00830466|"     The researchers want to collect data on safety and efficacy of combined pulsed dye laser and     rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye     laser alone, which is the current standard of care.      This single center pilot and feasibility study will have a target enrollment of 40 port wine     stain subjects at the Beckman Laser Institute and Medical Clinic, University of California,     Irvine.   "
227515|NCT00830479|"     This study seeks to compare outcomes after anti-reflux surgery (ARS) for correction of     low-grade vesicoureteral reflux (VUR). It is a randomized controlled open-label trial of     conventional open anti-reflux technique versus endoscopic anti-reflux technique with     injection of dextranomer/hyaluronic acid copolymer (Deflux). Primary endpoint will be     resolution of VUR at initial cystogram after ARS. Secondary outcomes will include incidence     of postoperative UTI, resolution of VUR at 1-year cystogram after ARS, surgical     complications, and quality of life measures after ARS.   "
227501|NCT00830297|"     Treat-to-target trial of basal Insulin in Post-transplant hyperglycemia (TIP): efficacy and     safety of a novel protocol in renal transplant recipients receiving a tacrolimus-based     immunosuppression      DESCRIPTION:      A prospective, randomized safety and efficacy study of long-acting insulin (Insulatard®) as     therapy against post-transplant hyperglycemia in renal transplant recipients      OBJECTIVES:      Primary Objective:      To demonstrate superiority of long-acting insulin (Insulatard®) against post-transplant     hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c      Secondary Objectives:        -  To assess the average post-transplant glucose levels in renal transplant patients under          conventional blood-glucose lowering therapy during a period of at least 14 days after          transplantation by measuring the capillary blood glucose levels four times daily in both          groups of patients (fasting, before lunch, before supper, after supper)        -  To detect the number of post-transplant patients who - without any history of          pre-transplant diabetes - develop at least one episode of post-transplant hyperglycemia          (> 140 mg/dl before supper)        -  To detect the average number of hyperglycemic episodes in post-transplant patients with          at least one episode of post-transplant hyperglycemia and without any history of          diabetes        -  To assess the amount of (long-acting) insulin (in IU) needed in order to obtain a target          capillary blood glucose level in the range of 110 mg/dl to 120 mg/dl before supper in          post-transplant patients with incidence of hyperglycemia        -  To assess the safety of long-acting insulin in controlling post-transplant hyperglycemia          (especially with regards to episodes of hypoglycemia (glucose-level < 60 mg/dl)        -  To assess the prevalence of post-transplant diabetes, as diagnosed by an abnormal oral          glucose tolerance on days 90, 180 and 360 after transplantation, in the group of          patients which has been treated with long-acting insulin, in comparison to patients who          received conventional treatment        -  To assess the morbidity (hospitalization, infections, subsequent episodes of surgery,          requirement of non-immunosuppressive, non- blood glucose lowering medication) in the          group of patients with long-acting insulin for hyperglycemia, in comparison to patients          randomized into the group receiving conventional treatment        -  To assess the renal outcome (creatinine levels, rejections) in the group of patients          which is foreseen to be treated with long-acting insulin for hyperglycemia, in          comparison to patients randomized into the group receiving conventional treatment   "
227502|NCT00830310|"     This study is a modular intervention that is intended to improve treatment adherence among     individuals with bipolar disorder on atypical antipsychotic therapy who have been identified     as having treatment adherence problems.   "
227503|NCT00830323|"     Neuraminidase inhibitors (NAI) are effective anti-influenza antiviral treatment. During their     use in experimentally infected patients, it has been shown that the viral load detected in     the nasal fluid is decreasing significantly faster than in non treated patients. During     clinical practice, the emergence of NAI-resistant strains has been observed. These strains     remain rare, but their emergence seemed to be related to the mis-use of the NAI products     (insufficient duration or dosage). This observation as well as the detection of NAI-resistant     viruses in the community raises concerns about putative emergence of resistant clones in the     specific context of a pandemic, when the use of NAI will be very large in the aim of reducing     transmission, and subsequently the impact of the emerging virus.      In this context, it is important to determine the putative interest of alternative     strategies.      Although zanamivir and oseltamivir are both issued from the same class , this combination may     lead to a more rapid viral clearance in the infected cases, and to a reduction in the     emergence of resistant sub-clones, and alternatively, might lead to a competitive inhibition.     The evaluation of these combinations needs to be conducted in vivo.      Among available anti influenza antivirals, M2 blockers have been previously used. Although     their efficacy against A H5N1 remains to be ascertained, their use in combination with NAI     should also be evaluated in the context of a preparation for a possible pandemic and     determination of the stockpile.      Therefore, the evaluation of combination therapies in the treatment of a virologically     suspected influenza will be investigated in primary care during the winter season 2008-2009.   "
227504|NCT00830336|"     The study will compare the relative bioavailability (rate and extent of absorption) of 200     mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.;     distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX oral suspension     distributed by Pfizer labs, a division of Pfizer Inc. following a single oral 10 mL dose (400     mg) in healthy adult subjects administered under non-fasting conditions.   "
227505|NCT00830349|"     The objective of this study was to compare the rate and extent of absorption of risperidone 1     mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablet under     fasting conditions.   "
227506|NCT00830362|"     The purpose of this study is to examine the effects of propranolol versus placebo on     responses to cocaine cues in cocaine dependent individuals.   "
227507|NCT00830375|"     This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.   "
227508|NCT00830388|"     Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as     a positive Potassium Hydroxide (KOH) using calcofluor. Ketoconazole 2% foam will be used to     determine its effectiveness, safety and satisfaction when used to treat tinea versicolor.   "
227509|NCT00830401|"     This is a comparative, controlled trial to evaluate the impact of treating undetected,     asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.   "
227510|NCT00830414|"     This study compared the rates and extents of medroxyprogesterone absorption from two     medroxyprogesterone acetate injection formulations following single 150 mg intramuscular (IM)     injections to healthy postmenopausal women.   "
227511|NCT00830427|"     This study (A7881006) is the first multiple dose study in moderate asthmatic subjects and     aims to determine the safety and efficacy of PF-00610355 when subjects take PF-00610355 on a     daily basis for 4 weeks in subjects maintained on inhaled corticosteroid.   "
227529|NCT00830661|"     Anal fistulae are a difficult problem to treat. The optimal treatment for fistula involving     the anal sphincter is unclear. Two standardly used methods of treatment are the ligation of     intersphincteric fistula track (LIFT) procedure and the use of an anal fistula plug. The     purpose of this study is to exam the rate of fistula closure between the LIFT procedure and     the use of a fistula plug   "
227530|NCT00830674|"     The primary objective of this study is to assess the safety and tolerability of KRN23 after a     single intravenous (IV) and subcutaneous (SC) administration in XLH patients.   "
227512|NCT00830440|"     The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier     device compared to a diet control in patients who require weight loss prior to their     Bariatric surgery.      It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry     patients will receive an implant of the EndoBarrier device and the other 10 patients will     receive the principle investigator's standard of care diet program. All patients will be     treated for 12 weeks with the exception of the last 10 device patients who will continue to     24 weeks if the principle investigator determines that it is safe and in their best interest     to continue.      The primary efficacy endpoint is:        -  Assessment of the difference in % excess weight loss between the 2 groups      Secondary endpoints are:        -  Resolution or Improvement in type II Diabetic status as defined as:        -  Resolution = patient is off their diabetes medication and has normal diabetic blood          parameters (fasting glucose)        -  Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction          in dosing or frequency of their diabetic medication        -  The percent of patients who achieve at least a 10% excess weight loss will be calculated          as a secondary outcome.   "
227516|NCT00830492|"     Objective: To compare the efficacy of using mild ovarian stimulation protocol and     conventional stimulation protocol in IVF outcome.      Design: Prospective randomized trial      Setting: University IVF setting. Patient(s): The study compromised a total 200 subinfertile     couple that women had regulary menstruation.      Intervention(s): Patients were randomized to treatment clomiphene citrate, gonadotropin and     GnRH antagonist (100 patients) or GnRH agonist and gonadotropin ( 100 patients).      Main outcome measure: Clinical pregnancy rate.      Key Words: clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization,     pregnancy rate.   "
227517|NCT00830505|"     The purpose of this study is to compare the effects of Fluticasone/ salmeterol combination     and double the dose of fluticasone on airway hyper-responsiveness to methacholine.   "
227518|NCT00830518|"     This is an open-label, multicenter, phase 2 study of MLN8237 in patients with acute myeloid     leukemia (AML) or myelodysplastic syndrome (MDS).   "
227519|NCT00830531|"     The main goal of the study is to obtain pharmacokinetic and safety data of bumetanide in     newborns with refractory seizures. The overall hypothesis is that bumetanide, added to     conventional antiepileptic (antiseizure) medications, will be a safe and well tolerated     medication, compared with conventional antiepileptic drugs alone.   "
227520|NCT00830544|"     The purpose of this study is to evaluate the pathological CR rate in breast and lymph nodes     of a novel neoadjuvant regimen for invasive breast carcinoma.   "
227521|NCT00830557|"     RATIONALE: Gathering medical information and collecting and storing samples of blood and     tissue to test in the laboratory may help doctors develop better ways to screen people at     risk for pancreatic cancer or other pancreatic disorders in the future.      PURPOSE: This clinical trial is collecting medical information and tissue samples from     patients with pancreatic cancer or other pancreatic disorders.   "
227522|NCT00830570|"     The purpose of this quasi-experiment study, which could also be classified as a prospective     observational intervention study, is to assess the impact of cytochrome P450 2C9 (CYP 2C9)     and vitamin K epoxide reductase complex, subunit 1 (VKORC1) testing within a primary patient     care setting.   "
227523|NCT00830583|"     An international consensual group recommends confirming the diagnosis of the Pompe disease     after a dried blood spot (DBS) with a dosage of the enzymatic activity in other tissue. This     strategy is currently used in the usual practice.      The aim is evaluate the prevalence of the Pompe disease among patients with progressive limb     girdle muscular weakness and/or axial deficiency, and/or respiratory insufficiency. The     diagnosis will be confirmed using DBS.   "
227524|NCT00830596|"     The long-term goal for this study is to understand the physiological mechanisms of various     forms of spinal manipulation in order to refine and improve this therapy for appropriately     selected patients. The objective of this study is to assess the effects of high-velocity     low-amplitude spinal manipulation and low-velocity variable amplitude spinal manipulation on     three types of sensorimotor abilities in patients with low back pain.   "
227525|NCT00830609|"     The rate of sustained virological response (SVR) in patients with chronic hepatitis C,     genotype 3, high viral load and without rapid virological response (RNA-HCV negative at week     4) is low. Standard of care of these patients include treatment with weekly peginterferon     plus 800 mg/day of ribavirin (RBV). Extended treatment to 48 weeks does not provide more     clinical benefit than the standard duration. The main hypothesis is that higher dose of     ribavirin may be better in terms of SVR than the standard dose.   "
227531|NCT00830687|"     The purpose of this study is to evaluate our experience in internal fixation of intracapsular     femoral neck fractures with the Targon FN implant prospectively and retrospectively in terms     of the outcomes and complications associated with the treatment.   "
227532|NCT00830700|"     While telemental health (TMH) programs are increasing nationally to address the inequity of     access to psychiatric services, there are few reports of their efficacy, particularly with     children. The current proposal will complete the second stage of our program development. In     the first stage, we established the feasibility of a TMH service and its acceptability to     families and PCPs. In the second stage of program development we will conduct a randomized     clinical trial (RCT) that will determine whether it is possible to use technological advances     to: 1) improve clinical outcomes for children with ADHD over outcomes achieved in usual PC;     and 2) adhere to an EBT protocol implemented through TMH. Future studies will examine whether     other types of complicated psychiatric disorders and EBTs are amenable to delivery via TMH.      The overall goal of this study is to determine whether an evidence-based model of care can be     faithfully implemented when delivered using TMH to children with ADHD living in rural areas     and can improve outcomes over treatment as usual (TAU) in PC. ADHD is an excellent focus for     assessment of TMH, as PCPs encounter this disorder frequently, EBT guidelines are available,     pharmacotherapy is the core treatment and is easily delivered in PC through     videoconferencing, and stabilization may be readily achieved for most youth.   "
227533|NCT00830713|"     In vitiligo, the melanocytes are lost from the skin in certain areas. One treatment for     vitiligo takes the melanocytes from areas of normal skin and places them on areas of that     same person's body which have lost their color. This is called the melanocyte-keratinocyte     transplantation procedure (MKTP). This procedure has been used successfully in over 3000     cases in India and Saudi Arabia. The purpose of this study is to see if it is effective when     performed at the investigators' institution.   "
227534|NCT00830726|"     The purpose of the study is to determine whether the excretion of renal water- and     salt-channels in the urine reflects the handling of water and salt in the kidneys, and     whether the excretion can be used to monitor and/or predict the effects of treatment of     certain heart or lung diseases.   "
227545|NCT00830869|"     This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary     purpose of this study is to determine the safety profile, establish the maximum tolerated     dose, and inform the phase 2 dose of IXAZOMIB administered intravenously in patients with     nonhematologic malignancies.   "
227546|NCT00830882|"     The objective of this study is to compare the peak dose relative bronchoprotection offered by     levosalbutamol and racemic salbutamol in mild to moderate asthmatics preselected into two     groups on the basis of their beta-2 adrenoreceptor polymorphisms.   "
227547|NCT00830895|"     To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell     carcinoma   "
227535|NCT00830739|"     Background:        -  Chronic nicotine exposure through cigarette smoking affects the level of the brain          chemical dopamine. Smokers who attempt to quit experience lower levels of dopamine,          which increases anxiety and triggers nicotine cravings that make quitting more          difficult.        -  Varenicline (Chantix) is a smoking cessation medication that is designed to reduce          nicotine craving and withdrawal by slightly increasing levels of dopamine in the brain.          Research has shown that varenicline is a safe, well-tolerated, and effective treatment          for nicotine dependence, but researchers are interested in learning more about how it          affects the brain and its function. Functional magnetic resonance imaging (fMRI) and          electroencephalography (EEG) will help researchers study the brain s response to          nicotine and varenicline.      Objectives:      - To explore how varenicline affects brain function and behavioral performance in current     smokers and healthy volunteers.      Eligibility:      - Individuals between 18 and 55 years of age who are either current smokers (10 or more     cigarettes per day) or healthy nonsmoking volunteers.      Design:        -  The study will involve nine testing and research visits over 5 to 6 weeks. The first          visit will provide an initial assessment and training on the tasks that will be          completed during the study.        -  Six testing visits will involve fMRI and EEG measurements of brain activity. Each visit          will contain two 2-hour scanning sessions, and each session will involve thinking tests.          During these visits, participants will receive varenicline and placebo tablets, and wear          nicotine patches and placebo patches that do not contain nicotine. Participants will not          be told which tablet or patch they are given. This is a crossover study so all          participants eventually get nicotine and placebo, as well as varenicline and placebo.        -  Two other visits involve different thinking tasks. These visits will not require fMRI or          EEG scans.   "
227536|NCT00830752|"     The syndrome of extremely restricted emotional competence, alexithymia, was originally     conceptualized in psychoanalytic research and is now empirically and experimentally studied     in clinical psychology and psychological medicine within the context of emotion regulation     using neuroscientific techniques. Alexithymia refers to an individual's inability or impaired     ability to name or express feelings and to distinguish them from the physical consequences of     an acute or chronic stress reaction. Modern brain-body-interface research suggests that     alexithymia represents a complex deficiency in cognitive processing and emotional regulatory     processes. The neurobiological basis is assumed to be a preconscious, automatic and     involuntary information transfer to the amygdalae of acquired representations of emotional     contents stored in ventromedial prefrontal cortical areas.      Alexithymia is not just emotional coldness, i.e. a limited emotionality, but essentially     the detachment of feelings from language. In alexithymia the link between affective phenomena     and language, understood as media-supported sign practices, is insufficient or even absent.      The purpose of our observational study is to better understand the neurobiological and     neuropsychological as well as linguistic and gestural processes and determinants of this     phenomenon   "
227537|NCT00830765|"     Preterm birth is the most common and costly complication in obstetrics. It complicates up to     11 % of all pregnancies and it is responsible for 70% of sick babies. Recently two studies     have shown that giving progesterone (a normal hormone made by the ovaries) prolongs gestation     in women who have had a preterm birth in an earlier pregnancy (and therefore are at risk for     another early delivery). There are other studies that show that this technique of giving a     weekly shot of progesterone does not prevent preterm birth. In addition, There are other     groups of patients who are at very high risk for preterm birth which have not been studied.     They include: 1.) Cervical cerclage (a stitch in the mouth of the womb); 2.) Multifetal     gestation (twins, triplets, etc.); 3.) Women with preterm (<34 weeks) rupture of the     membranes; 4.) Women with preterm labor during the current pregnancy with intact membranes     who have been tocolyzed (have their labor stopped and are getting ready to go home). We     purpose to give weekly shots of progesterone or a placebo in a randomized fashion to women in     the first group who are at risk for preterm delivery due to an early birth in a previous     pregnancy as well as the other four groups listed. If progesterone given weekly is successful     at preventing early delivery as compared to the placebo group then great benefit for these     women as well as future pregnancies would be accrued.   "
227538|NCT00830778|"     The incidence of complications after pancreaticoduodenectomy (PD) is around 50 %. The     postoperative course after PD is strongly dependent of the occurrence of pancreatic fistula     (POPF), which determines postoperative mortality, length of hospital stay and costs. The     incidence of POPF after PD is dependent of its definition, and is reported in up to 20% of     patients.      There is disagreement on whether to perform a pancreaticojejunostomy (PJ) or a     pancreaticogastrostomy (PG) after PD. The aim of the current randomized controlled trial is     to study whether PG significantly reduces the rate of POPF following PD for pancreatic or     peri-ampullary tumours. Secondary endpoints are the reduction of overall postoperative     complication rate and their severity.   "
227539|NCT00830791|"     This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees     of renal insufficiency.   "
227541|NCT00830817|"     The purpose of this study is to evaluate primarily the safety and tolerability and     secondarily the efficacy of topically applied WBI-1001 cream in patients with mild to     moderate psoriasis. Double-blind, randomized, placebo controlled study of 36 patients,     treated for 28 days plus a 7 day follow-up.in which the patients were divided into six     cohorts: Cohort 1 at 0.5% QD;Cohort 2 at 0.5% BID; Cohort 3 at 1.0% QD; Cohort 4 at 1.0% BID;     Cohort 5 at 2.0% QD; Cohort 6 at 2.0% BID.Efficacy assessed by PGA,target lesion assessment     and BSA. Safety assessed through vital signs, ECG, AEs and Plasma PK via Cmin, Cmax,Tmax and     AUCo-t.   "
227542|NCT00830830|"     This extended study will evaluate the efficacy and safety of intra-articular injections of     20mg/2ml dose HYALGAN in patients with pain due to osteoarthritis (OA) of the knee.   "
227543|NCT00830843|"     Recent study has shown that inhalatory sedation is a practicable, effective and not risky     method in Intensive Care Unit. Sevoflurane effect on cerebral system have been described in     previous studies: it causes an increasing of cerebral blood flow and a decrease of oxygen     cerebral consumption. Clinical strategy for Subarachnoid Hemorrhage is orientated to increase     cerebral blood flow to limit vasospasm phenomena after SAH. Scope of this study is to     evaluate the Cerebral Blood Flow variation associated to Isoflurane sedation versus     conventional sedation with propofol .   "
227544|NCT00830856|"     Cryptococcal Meningitis continues to be one of the most devastating AIDS defining illness in     sub-Saharan Africa. Despite the availability of azoles such as fluconazole for treatment,     mortality remains high with some studies showing 100% mortality. The investigators designed a     study to determine if timing of the initiation of antiretroviral therapy (ART) in patients     with cryptococcal meningitis and HIV would improve survival. The investigators hypothesis was     that early initiation of ART result in improved mortality for patients with HIV and     cryptococcal meningitis.   "
227548|NCT00830908|"     The purpose of this study is to test whether the stimulation of vascularization and cellular     metabolism on the scalp by use of the HairMax LaserComb will produce improvement in the     condition of scalp seborrheic dermatitis.   "
227549|NCT00830921|"     The treatment we are studying is Transcranial Magnetic Stimulation (TMS). In TMS, an     electromagnetic pulse is passed into the brain through a coil placed on the head. Previous     studies have shown TMS to be capable of altering brain activity in specific areas; for     example it has been used to improve mood in clinical depression. In this study we will assess     if, by targeting TMS to the brain area responsible for feeling breathless, participants'     breathlessness will be improved   "
227550|NCT00830934|"     The investigators aim to conduct a prospective open label randomized controlled trial to test     the hypothesis that following initial assessment by a physiotherapist, group care exercise     class is as effective in reducing pain as individual physiotherapy care.   "
227551|NCT00830947|"     To gather data indicating whether or not the OrthoAccel device speeds tooth movement in     people who use orthodontics (braces).   "
227552|NCT00830960|"     The study will compare the safety and efficacy of prasugrel, administered at different doses     with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS)     undergoing percutaneous coronary intervention.   "
227553|NCT00830973|"     This study will assess the impact of CYP450 2D6 genotype pharmacogenetic testing and the     corresponding prescribing impact for postmenopausal women using tamoxifen in a patient care     setting for prevention of recurrent breast cancer.   "
227554|NCT00830986|"     A significant number of patients experience postoperative cognitive changes following total     joint arthroplasty. Among other causes, the mental status change may be the result of fat and     bone marrow debris embolization. We hypothesized that the use of computer assisted total knee     arthroplasty, which does not utilize intramedullary alignment rods, would produce less fat     and bone marrow debris embolization and, hence, fewer mental status changes.   "
227555|NCT00830999|"     This study is being conducted to learn more about the role of diet and exercise in regulating     plasma triglyceride (fat) metabolism. The investigators will examine the effect of acute (24     hour) changes in energy intake and expenditure on fat metabolism the following day.   "
227556|NCT00831012|"     Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and     subtropical regions of the world. The purpose of this study is to test the safety of and     immune response to a new dengue virus vaccine in healthy adults.   "
227557|NCT00831025|"     The objective of this trial is to assess the clinical efficacy of a modified allergen extract     of Olea europaea pollen in the treatment of patients affected by allergic     rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to     olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the     medication.   "
227558|NCT00831038|"     Infants less than 2 years old who have been newly diagnosed with problems swallowing will     have pulmonary function tests performed to try to detect the presence of chronic lung     disease. Six months later after the infants have received appropriate therapy for their     swallowing problems, pulmonary function tests will be performed again to see if there has     been any change in their chronic lung disease.   "
227559|NCT00831051|"     This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8     mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride     components for the management of acute moderate to severe postoperative pain following     bunionectomy surgery.   "
227560|NCT00831064|"     To compare 4 commonly used bowel preparations in terms of efficacy, patient tolerability and     safety. All these 4 bowel preparations are likely to be efficacious and safe. However, those     with lower volume are likely to be better tolerated and completed by patients.   "
227562|NCT00831090|"     The purpose of this study is to better understand why some vein bypass grafts develop     narrowing. Evidence suggests that there is a relationship between inflammatory markers in the     blood and the narrowing that occurs in blood vessels. In this study, we will look at     inflammatory markers in the blood and how well the vein graft functions.   "
227563|NCT00831103|"     The purpose of this study is to determine the pharmacokinetics and dosage of EPB-348 that     best balances safety and efficacy among adult immunocompetent patients with an acute episode     of herpes zoster.   "
227564|NCT00831116|"     In April 2008, a coronary catheter based imaging system, LipiScan, was cleared by the FDA for     use in detecting lipid core containing containing plaques of interest (LCP). These plaques     are rich in cholesterol. The way that cholesterol and other lipids deposit with the coronary     artery is unique to each patient. This study is an organized attempt to observe the LCP and     the variety of ways that it presents in patients as detected by this recently approved     device. This information will be used for physician training and to observe the behavior of     the LCP in response to no therapy and currently approved therapies. The purpose of this     project is further medical knowledge of the LCP and its treatment.   "
227565|NCT00831129|"     The purpose of this research study is to examine if a combination of a cholesterol     lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective     in improving vascular inflammation (irritation of the vessels that transport your blood) and     other cardiovascular risk factors than the taking of simvastatin alone.   "
227566|NCT00831142|"     The long-term goal of this proposal is to provide a pre-treatment evaluation that can assist     in the rational selection of patients to undergo appropriate and definitive therapy for     prostate cancer. In so doing, it may be possible to further improve the numbers and     percentage of cancer patients who receive effective therapy that will cure the disease and     maximize their quality of life following therapy.        -  Aim 1: To evaluate the accuracy of T2W MRI, DCE-MRI and their combined data for staging          prostate cancer.        -  Aim 2: To evaluate the accuracy of MRI in determining tumor volume in the prostate          gland.        -  Aim 3: To evaluate the accuracy of MRI in grading prostate cancer.   "
227578|NCT00831298|"     The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and     activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates     to changes in activity cycles, and how sleep disturbances may affect your daytime alertness.      This project selects patients suffering from memory problems, or voluntary to be in our     Control Group. There are three parts to this study: Sleep Diaries, Behavioral Questionnaire,     and Activity Recordings   "
228528|NCT00847197|"     This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared     to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying     therapy.   "
227567|NCT00831155|"     The purpose of this study is to test two quit smoking therapies and to study brain function     while each therapy is being used. You will be randomly assigned (like flipping a coin) to one     of the two groups. The first therapy is Extinction-Based therapy (EBT). If you are in this     group, you will switch to smoking denicotinized cigarettes while wearing a 21 mg/d nicotine     patch for one month prior to your quit date. The second therapy is a standard Nicotine     Replacement therapy (NRT). If you are in this group, you will smoke your usual brand of     cigarettes up to the quit date. Following the quit date, both groups will undergo standard     nicotine replacement therapy (21 mg/d for 6 weeks; 14 mg/d for 2 weeks, 7 mg/d for 2 weeks).      In addition to the above, we will recruit a sample of former smokers who are now regular     users of e-cigarettes. This group [ECIG] will undergo the same screening and baseline     assessments as the EBT and NRT groups up to the completion of fMRI1.   "
227568|NCT00831168|"     BEADI is a dissemination trial, on standards of care of premature babies. The main objective     of BEADI is to assess whether an innovative 'active' strategy for the dissemination of     neonatal information (evidence reviews, interactive training workshop, benchmarking and     feedback, and ongoing support) is more likely to lead to changes in policy and practice than     the traditional (more passive) forms of dissemination in English neonatal units.      BEADI will focus on three areas of neonatal care for premature (22+0 to 26+6 weeks'     gestation) babies born in England: timing of surfactant therapy, staffing for resuscitation     at delivery, and temperature control (in line with the main Project 27/28 findings ).     However, the approach is applicable to a wide variety of clinical policies and practice.      The BEADI study has been granted ethical approval by MREC to use a subset of data collected     by EPICure2 up until 31st December 2006 (pre-intervention data). For the post-intervention     data, ethical approval has been granted for CEMACH to continue data collection against the     three clinical areas using a subset of data items captured in the PN:E2 form, for the three     month period between 1st January - 31st March 2007. Local research and development     departments of each trust have also been contacted.   "
227569|NCT00831181|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) before     surgery may kill more tumor cells and may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed. Giving oxaliplatin, leucovorin, and fluorouracil     after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying the side effects and how well giving combination     chemotherapy works in treating patients undergoing surgery for rectal cancer.   "
227570|NCT00831194|"     A clinical trial that uses personal digital assistants (PDAs) to assist in examining the     relationship between self reported stress, an objective biochemical indicator of stress     (salivary alpha amylase) and self-reported dietary lapse among type 2 diabetic adults who are     interested/undergoing in weight loss.   "
227571|NCT00831207|"     Cross-sectional study to assess the behavior of Beta-2 microglobulin and serum cytokines     TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy     (HAART) failure.   "
227572|NCT00831220|"     Objective: To investigate the potential role of endothelial dysfunction as a pathogenic     mechanism of cardiovascular events in COPD. Hypothesis: endothelial function is abnormal in     patients with COPD, particularly during exacerbations of the disease. Design: prospective and     controlled study performed in an university hospital. Population: we compare 4 groups of     subjects, 44 patients with stable COPD, 35 patients with acute exacerbation of COPD, 10     smokers or former smokers with normal lung function and 10 never smokers matched by physical     activity and BMI. Study variables: a) clinical variables: clinical information, physical     examination, pulmonary function tests, ECG and sputum culture; b) Biological variables:     number of Circulating Endothelial Progenitor Cells, vascular growth factors (vascular     endothelial growht factor and erythropoietin), systemic inflammation (C-reactive protein,     white blood cells), peripheral venous blood test (including hemogram, biochemical analysis     with glycemia, cholesterol, LDLcol, HDLcol); and c) systemic vascular reactivity assessment.   "
227573|NCT00831233|"     The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower     urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a     standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of     prostate cancer may be associated with LUTS and the symptoms may impact the ability to     urinate normally and thereby the quality of life for these patients.      Patients were randomly selected (like flipping a coin) to receive either degarelix or     standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment     period. During this period the relief of urinary symptoms was evaluated via a questionnaire     filled in by patients and addressing the severity and frequency of their symptoms.   "
227574|NCT00831246|"     This study will attempt to determine if the use of chewing gum can cause the early return of     bowel function after gynecologic surgery.   "
227575|NCT00831259|"     Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in     patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the     incidence of clinically silent brain infarction is unknown. We will assess the rate of     clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE)     in relation to the presence or not of a PFO.   "
227576|NCT00831272|"     The aims of the study are to test for treatment outcome differences in alcohol dependent     subjects randomly assigned to 12 weeks of treatment with NTX (50mg/day) or placebo among     those with one or two copies of the Asp40 allele of the mu-opioid receptor compared to those     homozygous for the Asn40 allele. Thus, the design of the study is a 2X2 cell double-blind     randomization to NTX or placebo stratified by genotype. To meet these aims, 150 alcohol     dependent outpatients with one or two copies of the Asp40 variant of the mu-opioid receptor     and 190 subjects homozygous for the Asn40 variant will be recruited across the four     participating sites.   "
227577|NCT00831285|"     The variation in starch and fibre composition of prepared barley tortillas will have a     significant effect on glycemic response.   "
227992|NCT00836680|"     The purpose of this study is to determine if the device is supplying sufficient diagnosis     results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of     an interal hernia into the Douglas pouch, as well as to determine the technical success of     using the device at the patient.   "
227579|NCT00831311|"     Primary Objective:        -  To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for          all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one          month after a three-dose primary series.      Secondary Objectives:        -  To describe in each group the immunogenicity parameters one month after the three-dose          primary series.        -  To describe safety profile after each vaccination in both groups.   "
227580|NCT00831337|"     This study is to evaluate the role of probiotics in the treatment of portal hypertension. In     particular the role of probiotics on gut microbiota in liver cirrhosis patients will be     studied and compared with cytokines and other substances implicated in the pathogenesis of     portal hypertension. The hypothesis whether probiotics may change the prognosis of patients     with portal hypertension will be studied. The hypothesis whether probiotics may halt the     pathologic cascade of events leading to various complications (e.g. hepato-renal syndrome,     spontaneous bacterial peritonitis, bleeding varices) will be reviewed.   "
227581|NCT00831350|"     This is a study of subjects with retinal vein occlusion (RVO) specifically looking at the     difference in outcomes between patients with posterior vitreous detachment (PVD) and those     without PVD. Posterior vitreous detachment is a condition where the gel-like substance that     occupies the space between the retina and the lens of the eye liquefies and separates from     the retina. 20 subjects from Barnes Retina Institute will be enrolled in this study. Based on     a pre-treatment ultrasound (a test utilizing high-frequency sound waves to look at the inside     of the eye), high resolution OCT (a noninvasive procedure called optical coherence tomography     to check the thickness of your retina) and clinical exam, subjects will be assigned to one of     2 groups at baseline: Group 1 will be those with PVD and Group 2 will be those without PVD.     Then subjects will receive monthly intravitreal (inside the eye) injections of Ranibizumab.   "
227582|NCT00831363|"     The hypothesis for the present study was that patients receiving a minimally invasive total     hip arthroplasty will show a faster improvement on walking ability and mobilization in the     immediate postoperative period compared to patients with the standard Hardinge approach.     Therefore, the main goal was to evaluate the differences in early rehabilitation of these two     different surgical approaches by gait analysis and electromyographical examination as     objective methods.   "
227583|NCT00831376|"     The objective of this study is to compare the relative bronchoprotection (at trough)     conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to     moderate asthmatics. Patients will be preselected into two groups on the basis of their     beta-2 adrenoreceptor polymorphisms. The investigators will evaluate if this has a     differential effect on the bronchoprotection conferred by both formulations of salbutamol, as     evidenced by a rebound in airway hyper-responsiveness, in order to determine whether any     effect can be explained by the S enantiomer in the racemic formulation.   "
227584|NCT00831389|"     The purpose of the study is to compare the glycemic control during and following aerobic     exercise using either an open or closed-loop insulin delivery system.   "
227585|NCT00831402|"     Goals of the study :        1. To study maternal thyroid function during pregnancy with or without supplementation with          pregnancy tablets fortified with iodine        2. To establish reference values of thyroid function at different stages of pregnancy (3          trimesters)        3. To precise screening strategy of iodine deficiency in our population and suggest          recommendation for its prevention.   "
227586|NCT00831415|"     The primary objective of this study is to evaluate the long-term safety of desvenlafaxine     succinate sustained release tablets during 10-month open-label treatment of Japanese subjects     with major depressive disorder (MDD).      The secondary objective is to evaluate the long-term response of subjects receiving     desvenlafaxine succinate sustained release tablets by clinical global evaluation, general     well-being and absence of symptoms.   "
227591|NCT00831480|"     The purpose of this multicenter, pilot, open-label, Phase II clinical trial is to discover if     Everolimus(RAD001) is safe and effective in people who have advanced kidney cancer (renal     cell carcinoma - RCC).      Since 2002, Everolimus has been studied in more than 2500 patients with various types of     cancer as a single agent (a drug that is used alone to treat the cancer) or in combination     with a number of well known anticancer therapies. Various studies, in animals such as in mice     with cancer and in humans with cancer have shown that Everolimus can slow the growth of     cancer.      Everolimus will be taken in pill form by mouth daily for 3-5 weeks followed by surgery to     remove the effected kidney. After 2-4 weeks following the surgery, Everolimus will be resumed     at the same dose.   "
227592|NCT00831493|"     Primary Endpoint:      To determine the maximum tolerated dose (MTD) of vorinostat + radiation therapy (RT) in     patients with locally advanced pancreatic cancer (LAPC).      Secondary Endpoints:        1. To assess the efficacy of vorinostat + RT in patients with LAPC as estimated by median          overall survival.        2. To determine the radiological response as assessed by regular computer tomography (CT)          and/or dynamic contrast enhanced computer tomography (DCE-CT) among patients treated          with vorinostat and RT.        3. To evaluate the occurrence of symptoms and correlate to disease progression and          tolerance to treatment using the MD Anderson Symptom Inventory-Gastrointestinal Module          (MDASI-GI) self-reporting tool.        4. To correlate serum cytokine levels with symptoms and treatment outcomes.   "
227593|NCT00831506|"     This study has been designed to confirm, in healthy subjects, the lack of a clinically     important pharmacokinetic interaction between Dimebon, at the proposed maximum commercial     dose of 20 mg TID (administered every 8 hours), and digoxin (Lanoxin®) 0.125 mg QD, a     sensitive P-gp substrate recommended by FDA.   "
227594|NCT00831519|"     The aim of this study is to test and compare biochemical, hematological, and inflammatory     factors in diabetic and healthy pregnant mothers and in their newborns.   "
227595|NCT00831532|"     1. To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic          impairment to subjects with normal hepatic function.        2. To assess the safety and tolerability of Dimebon in subjects with hepatic impairment and          subjects with normal hepatic function.        3. To explore the pharmacokinetics of Dimebon in subjects with severely-impaired hepatic          function.   "
227993|NCT00836693|"     The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg     administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5     (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on     tolerability.   "
227596|NCT00831545|"     The study implies a 2 step study design. Patients are enrolled into 3 separate groups for     melanoma, breast, and non-small cell lung cancer. In the first step, 21 patients per disease     group are enrolled. If >=2 objective responses (SD, PR, or CR) out of 21 evaluable patients     are observed, enrollment continues for other 45 patients as a whole, where response will be     positively evaluated if >=10 patients will respond. If <2 objective responses out of 21     evaluable patients per disease group are observed, this(ese) group(s) will no longer be     treated with temozolomide.   "
227597|NCT00831571|"     This research study will examine how often hypersensitivity, or allergic reactions, occur in     patients receiving the chemotherapy medication oxaliplatin. Hypersensitivity reactions can     vary from a transient skin rash and fever to more severe symptoms such as shortness of     breath, chest tightness, and a more severe allergic reaction that can affect blood pressure     called anaphylaxis. We will be examining how often hypersensitivity reactions occur and how     severe the reactions are when they occur. We will also examine whether there are factors that     place people at risk for developing hypersensitivity reactions to oxaliplatin. In an optional     portion to this study, we will examine whether allergy skin testing can predict whether     someone will develop a hypersensitivity reaction.      Participants who develop a moderate to severe allergic reaction to oxaliplatin will be     invited to participate in an additional portion of the study examining a desensitization     process. This part of the study will examine whether a desensitization process can prevent     future hypersensitivity reactions to oxaliplatin in patients who previously developed     moderate to severe hypersensitivity reactions and allow therapy with oxaliplatin to continue.   "
227598|NCT00831597|"     A phase II trial to evaluate the efficacy and safety of combination bendamustine and     rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. It is     hypothesized that the BR combination will produce at least a 70% overall response rate.   "
227599|NCT00831610|"     The purpose of this study is to quantify the skin sensation of the anterior abdominal wall of     the post-bariatric patients submitted to anchor-line abdominoplasty without flap undermining.      Additional purposes were: quantify topographically the abdominal skin sensation of the Normal     weight, Morbid Obese and Former Morbid Obese after bariatric surgery (before and after the     abdominoplasty - excess skin surgical removal without flap undermining -> Anchor Line     Abdominoplasty).   "
227600|NCT00831623|"     The purpose of this study is to determine hypofractionated conformal proton beam radiation     therapy of prostate cancer can achieve similar treatment benefits as our current     institutional standard with conventional fractionation.   "
227601|NCT00831636|"     This is non randomised, open label, dose finding, efficacy and safety study, enrolling     patients with advanced (stage III and IV) ovarian cancer It will be conducted in two     successive phases. Phase II has a two-step design   "
227602|NCT00825227|"     Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue     Associated With Taxane Chemotherapy Alone or in Combination With Other Agents   "
227603|NCT00825240|"     The overall goal of this study is to explore colorectal cancer patients' concerns and     interest about their health and behavior changes post treatment. Investigators will conduct     formative research, which includes qualitative interviews, to assess the issues that cancer     survivors are willing to work on as they transition out of active treatment.      The specific aims are as follows:      Aim 1: Use qualitative interview methods to describe the taxonomy of domains health promotion     and illness prevention behavior changes for which colorectal cancer survivors need new     information, skills training and support.      Aim 2: Explore colorectal cancer patients' perceptions of their post treatment functional     status.      Aim 3: Explore the impact of cancer, treatment, and co-morbidities on colorectal cancer     patients' health goals and functional status.   "
227613|NCT00825370|"     We are testing whether patients who received protocolized pain management (1 mg of IV     hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the     patients wants more) will have better pain relief and no more adverse events than patients     receiving discretionary care, in which the patients receives whatever IV opioid the treating     physician wants to give, in whatever dose.   "
227604|NCT00825253|"     This trial is conducted in Europe. The aim of this clinical trial is to compare the     pharmacodynamics (i.e. the glucose-lowering effect of the study medication over the entire     observation phase from the time of administration and the efficacy period) and the     pharmacokinetics (i.e. amount of the study insulin that can be determined in the blood) of a     treatment with biphasic insulin aspart 30 (BiAsp 30) administered once, twice or thrice daily     and biphasic human insulin 30 administered once daily in type 2 diabetic subjects   "
227605|NCT00825266|"     The purpose of this study is to evaluate 1) the incidence of insulin resistance (a     pre-diabetic state) in patients with pulmonary hypertension, and 2) test the utility of a     validated PH therapy (Tracleer) versus Pioglitazone in the treatment of those patients found     to have insulin resistance.   "
227606|NCT00825279|"     The success of stent implantation has led to the increasingly widespread use of them in the     treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent     restenosis is still a limit for this therapeutic mode (Serruys, Rodriguez) the new generation     of stents with improved coating materials and the development of polymers that release     different kinds of drugs that prevent the activation and/or proliferation of smooth muscle     cells (ultimate cause of restenosis) (Grube, Rodriguez). shows major improvements on this     matter. The new generation of stents with biodegradable polymers and short time of drug     release gives new advantages to this therapeutic, multiple studies and registries challenge     this new devices (Taxus I and II, RAVEL, SIRIUS, ERACI II and III).      For this reason the present study aims to compare a stainless steel stent with a drug eluting     stent with coated of biodegradable polymer matrix hemoparin and paclitaxel.   "
227619|NCT00825461|"     The PICOWO research group in corporation with the University of Amsterdam (Artificial     Intelligence) has developed a computer simulationmodel of eating disorders (Bosse, Delfos,     Jonker & Treur, 2003). In a running Phd project we want to add ghrelin to the model. The idea     for this current research is to collect clinical information about the functioning and     (patho)physiology of ghrelin in patients with AN, so we can extend the simulation.   "
228529|NCT00847210|"     The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole     modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with     Symptomatic Gastroesophageal Reflux Disease.   "
227607|NCT00825292|"     Colon cancer is the third most common cancer in western society. To prevent colon cancer it     is recommended for people to undergo a screening colonoscopy at the age of fifty. The purpose     of the colonoscopy is to remove polyps, since some of these lesions are precancerous.     Precancerous polyps are called adenomas. This method of prevention is effective, but the     standard colonoscopy currently used does not detect all polyps. Studies have reported a polyp     miss rate of about 24%. Furthermore, we are unable to distinguish precancerous polyps from     benign polyps, also known as hyperplastic polyps, with standard colonoscopy. This results in     all polyps being removed at time of colonoscopy, even the benign polyps.      To help improve the detection of colon polyps new endoscopic technologies have been     developed. These technologies include high definition white light (HDWL)and high definition     narrow band imaging (HDNBI). HDWL improves the overall resolution of the images seen during     colonoscopy. HDNBI can help us better classify polyps by enhancing their tissue appearance as     well as seeing small blood vessels and capillaries.      The goal of this study to determine if HDNBI imaging shows an increased polyp detection rate     when compared to the current standard colonoscopy. In addition to develop a classification     system to help better differentiate between precancerous polyps and their benign counterparts     using HDWL and HDNBI.   "
227608|NCT00825305|"     This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick     Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus     abbreviated schedule) in healthy adults 18 to 50 years of age in China   "
227609|NCT00825318|"     In this study, the researchers want to find out how patients who have ultrafiltration     (removal of excess fluid) 6 times a week and twice-weekly dialysis (removal of excess fluid     and waste products) do in terms of their blood pressure and weight. The researchers believe     that maintaining patients at their estimated target weight throughout the week using daily     ultrafiltration will reduce their blood pressure to levels shown in other similar studies.     Such a reduction in blood pressure may reduce the incidence of cerebral vascular disease,     peripheral vascular disease, coronary artery disease, and congestive heart failure. The     researchers also believe that patients' quality of life will improve while they are     undergoing daily ultrafiltration.      Studies show that more frequent dialysis treatments result in fewer symptoms for patients.     The patients feel better and avoid the weight gains and symptoms that patients have on three     times a week dialysis. In addition, their blood lab results are better controlled, requiring     less medication.   "
227610|NCT00825331|"     Periprocedural management of guidewire placement and removal in patients needing cardiac     catheterization by use of marking of the access site and removal procedure due to a graduated     scheme   "
227611|NCT00825344|"     Inguinal hernia repair is one of the most frequently performed operations in young men.     Persistent pain after inguinal surgery represents a significant cause of disability,     occurring in between 15%-35% of cases. In a majority of these patients, their groin pain     persisted after a previous hernia repair. The main type of chronic postsurgical pain is     neuropathic, caused by injured nerves. One of the principal components in the pathophysiology     of postsurgical pain is cytokines, specifically tumor necrosis factor (TNF). In animal     studies, injecting TNF inhibitors before nerve injury can reduce pain behaviors and     neuropathology. Finding a way to reduce the incidence of postsurgical pain after hernia     repair could enhance function, and reduce the need for opioids and other analgesics. The     investigators intend to conduct the first randomized, controlled study evaluating whether     preemptive administration of a tumor necrosis inhibitor can reduce postoperative pain and     opioid consumption after hernia repair. This is important because the degree and intensity of     postsurgical pain is a major predictor for the development of chronic postsurgical pain.   "
227612|NCT00825357|"     There are no clear markers to identify sepsis and acute lung injury at early stage in     clinical settings which would result in improved survival of the patients. In collaboration     with the research team led by Dr. Zhang at St. Michael's Hospital, Toronto, we have initiated     a pilot study looking for biological markers to detect severe sepsis and ARDS. We have found     that human neutrophils peptides (a-defensins), certain coagulation variables and cytokine     levels are very sensitive markers to differentiate severe sepsis, ARDS from cardiovascular     diseases in ICU patients. These findings may provide valuable information for therapeutic     guideline in clinical practice. The present study will focus on testing 'biological markers'     to identify patients with sepsis and acute lung injury. We will examine the roles of three     components of markers including inflammation, neutrophil activation and coagulation. We are     hoping that this proposed translational research will help develop novel therapeutic strategy     in sepsis and acute lung injury patients.   "
227614|NCT00825383|"     Effect of Dietary Fiber on glucose, lipid, and mineral metabolism in patients with non     insulin dependent diabetes mellitus.   "
227616|NCT00825422|"     Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's     postoperative reconvalescence especially functional rehabilitation. Efficient and safe     methods for postoperative analgesia are, therefore, mandatory. The application of opioids are     the most frequently used therapies for postoperative pain relief but it very often results     side effects. Local anesthetic wound infiltration is widely recognized as a useful adjunct in     a multimodal approach to postoperative pain management. In the setting of spine surgery, a     single bolus administration of a local anesthetic is a useful method (with a reduction in     parenteral morphine consumption during the 48 first hours) but has a limited effect because     of its short duration of action. Prolonged administration through a multi-holed catheter     positioned by the surgeon at the end of the procedure could increase the duration of action     and may thereby improve the efficacy of local wound infiltration. Easy and effective, this     new modality of administration has expanded the indications for parietal infiltrations toward     major painful procedures.      We designed this study to determine whether local anesthetic (compared with saline solution)     continuous wound infiltration during the first two days after posterior lumbar arthrodesis on     degenerative spine, could improve postoperative analgesia at short-term but particularly at     mid-term (two months) and long-term (six months), in order to decrease postoperative lumbar     pains (resulting in best life quality, opioid consumption limited and rehabilitation     hastened) and postoperative hyperalgesia areas. The postoperative analgesic and     antihyperalgesic efficacies; the postoperative rehabilitation at mid-term and long term, and     the safety of opioid administration and multi-holed parietal catheter will be compared in the     two groups (control and study).   "
227617|NCT00825435|"     This study will evaluate the impact of adding coronary computed tomographic angiography (CTA)     on health care costs for diagnosing patients with acute chest pain.   "
227618|NCT00825448|"     The aim of the study is to compare the hospitalisation period in ORL surgery for two groups     of patients. One of them will be treated for alcohol addiction to weaning them before the     surgery ORL. The other group will be treated with usual methods.   "
228541|NCT00847366|"     This is an open label trial for patients currently enrolled in other perifosine trials.   "
227620|NCT00825474|"     Presently,the diagnostic method of small hepatocellular carcinoma has been greatly elevated     in China.The treatment is being from simplification to diversification,from entirety to     individualization.Confronting small hepatocellular carcinoma,we not select simple operation     treatment but select a treatment that have more predominance and more fitting with patients     in various kinds of treatment methods;including operation ,TACE,PEI,et al.which is better ?     There are many arguments.   "
227621|NCT00825487|"     This is an open-label, dose escalation study of intravenous ARQ 621 administered to patients     with late-stage solid tumors or hematologic malignancies.   "
227622|NCT00825500|"     Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe     migraine headache with or without aura in an outpatient setting.   "
227623|NCT00825513|"     The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL     following cataract surgery.   "
227624|NCT00825526|"     The purpose of this study is to determine if Mindfulness Based Stress Reduction (MBSR) is an     effective intervention for lowering blood pressure in early unmedicated hypertensives.   "
227625|NCT00825539|"     Part 1 of the study will assess the enhancement of task-related brain activation (BOLD     response) in key brain areas in schizophrenia during the performance of working memory,     episodic memory and visual activation tasks as measured by functional magnetic resonance     imaging (fMRI) in people with schizophrenia. Part 2 of the study will assess the safety and     tolerability of multiple doses of AQW051 in people with schizophrenia.   "
227626|NCT00831649|"     The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of     natalizumab in subjects with active rheumatoid arthritis (RA) receiving concomitant     methotrexate (MTX)   "
227627|NCT00831662|"     The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium     ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.   "
227628|NCT00831675|"     To describe the safety of the 2004-2005 pediatric formulation of the inactivated,     split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with     the Package Insert, in children aged ≥ 6 months to < 36 months.      To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine     Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in     children aged ≥ 6 months to < 36 months   "
227629|NCT00831688|"     The purpose of this study to date, is that no causal therapy for Meniere's disease has been     discovered. Local overpressure treatment for Meniere's disease is a new treatment form that     has been shown in animal and human experiments to reduce the endolymphatic hydrops, a     condition that is generally believed to be the pathologic hallmark of Meniere's disease. This     study analyzes the efficacy of local overpressure treatment by measuring subjective vertigo     severity and objective audiovestibular function parameters.   "
227630|NCT00831701|"     Current therapeutic options for ureteral stones include active intervention as well as     conservative watch and wait approaches. Endoscopic treatment of ureteral stones has a high     success rate and reliably results in immediate stone removal However, surgical as well as     anaesthetic risks are not negligible and serious complications are possible. For many     patients, a conservative treatment is an appealing option. Watchful waiting, however, not     always results in stone clearance and may be associated with recurrent renal colics.      The therapeutic potential of alpha-blockers for ureteral stone disease has been investigated     prompted by the detection of alpha-receptors in ureteral smooth muscle cells. Blocking of     such receptors, which are predominantly located in the distal part of the ureter results in     relaxation of the ureteral wall and modulation of peristaltic activity. This mechanism has     been proposed to facilitate stone passage for ureteral calculi.      Numerous clinical trials have revealed a significant improvement of the stone expulsion rate     using the alpha-blocker tamsulosin. Most of these studies were randomised but none were     performed in a double-blind and placebo-controlled fashion. Therefore, the objective of this     trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a     randomised, double-blind, placebo-controlled setting.   "
227631|NCT00831714|"     The main goal is to provide additional information to the risk-benefit assessment of the     drug.   "
227645|NCT00831896|"     This study is a multicenter, open-label, dose escalation, phase 1 study of TAK 701 in adult     patients with advanced nonhematologic malignancies. This study will be the first to     administer TAK 701 to humans. The primary purpose of this study is to determine the safety     profile, tolerability, and pharmacokinetics profile of TAK-701.   "
227632|NCT00831727|"     The purpose of the present study is twofold. First, we will attempt to examine the role that     emotion regulation and self-presentation play as potential moderators in the expressive     writing paradigm. We hypothesize that expressive writing participants who demonstrate greater     abilities to regulate their emotions at baseline will improve more on our outcome measures.     We also hypothesize that those expressive writing participants who demonstrate higher levels     of self-presentation at baseline will improve less on our outcome measures.      The second aim of the study has two related objectives. First, we will attempt to investigate     whether the expressive writing intervention can increase and enhance an individual's emotion     regulation abilities. Related to this, we will then go on to examine whether emotion     regulation can be looked at as a potential mechanism of action in the expressive writing     procedure. Related to these two objectives, we hypothesize that in comparison to the control     group, participants in the expressive writing condition will show increases in their ability     to regulate their emotions from baseline to four week follow up. Moreover, we predict that     greater gains in emotion regulation abilities for the expressive writing participants will be     significantly related to greater gains in outcome measures.   "
227633|NCT00831740|"     Assessing Communication Therapy in the North West (ACT NoW) is a research project which aims     to evaluate the effectiveness, cost effectiveness and service user preferences for     communication therapy following stroke when compared to an attention control.   "
227684|NCT00833105|"     The purpose of this study is to determine if tetraplegic individuals with incomplete spinal     cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are     able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new     robotic therapy device.      The hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects     with incomplete SCI will result in improved strength, sensation, and functional movement in     treated limb(s).   "
227634|NCT00831753|"     The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T     vaccine has immunological and safety profiles that are comparable to those of the control     vaccine that is already marketed (Infanrix®Hexa)      Primary Objective:      To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP~T combined vaccine induces an immune     response that is at least as good as the response following Infanrix®Hexa in terms of     seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months)      Secondary Objectives:        -  To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep          B-PRP~T and Infanrix®Hexa) one month after the third dose of the primary series.        -  To assess the overall safety in each group one month after each dose of the primary          series and through the entire study.   "
227635|NCT00831766|"     The purpose of this study is to:        -  Test the safety of the research study drug, lenalidomide, when given with Idarubicin and          Cytarabine        -  See how many respond to combination treatment with lenalidomide, Idarubicin and          Cytarabine        -  See how long people respond to this combination therapy        -  See how long people live after being treated with this combination of drugs   "
227636|NCT00831779|"     The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity   "
227637|NCT00831792|"     The goal of this clinical research study is to learn if a decrease in the levels of prostate     specific antigen (PSA) may be linked with the status of prostate cancer that has spread to     the bones. Researchers also want to learn how changes in your blood PSA level might affect     the rebuilding of healthy bones while you are being treated with TKI258 for prostate cancer.   "
227638|NCT00831805|"     The main objective of the study is to assess the rate of patients with psycho-cognitive     troubles among hospitalised elderly patients.   "
227639|NCT00831818|"     Weight retention after pregnancy contributes to increasing rates of obesity. There is     evidence that breastfeeding is accompanied from changes in fat mobilisation and fat mass,     nevertheless there are no data on the effects of breastfeeding on appetite-regulation. This     study aims to investigate the direct effect of breastfeeding on the systemic levels of     appetite-regulating hormones: ghrelin and PYY. Blood samples will be obtained at five time     points (before, during and after breastfeeding) in ten mothers of healthy infants who     breastfeed on demand and in ten mothers of healthy infants who do not breastfeed. All mothers     will be fasting since 4 hours. The results will bring information on a possible direct effect     of breastfeeding on appetite-regulatory hormones.   "
227640|NCT00831831|"     OBJECTIVE: To investigate if, among women exposed to physical violence during pregnancy, does     a targeted intervention consisting of safety planning and referral to community advocacy     services decrease rates of adverse perinatal outcomes including antepartum hemorrhage or     infection, low birthweight, and perinatal death.      DESIGN: A randomized controlled trial. SETTING: Surrey Memorial Hospital and BC Women's     Hospital in British Columbia, Canada PARTICIPANTS: Pregnant women experiencing intimate     partner violence MAIN OUTCOME MEASURES: We are interested in perinatal outcomes such as birth     weight and preterm labour.      DATA ANALYSIS: Outcomes for women in each arm of the trial will be compared in an intention     to treat analysis. Changes in risk for adverse outcomes associated with the study     intervention will be estimated by the odds ratios calculated by the logistic regression     model.   "
227641|NCT00831844|"     This phase II trial is studying the side effects and how well cixutumumab works in treating     patients with relapsed or refractory solid tumors. Monoclonal antibodies, such as     cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them.   "
227642|NCT00831857|"     The primary objective of the study is to evaluate the feasibility of 89Zr-bevacizumab PET     imaging as a biomarker before and during treatment with sunitinib or bevacizumab plus     interferon in patients with RCC. 89Zr-bevacizumab PET imaging will be regarded a promising     biomarker if the target for treatment (VEGF) can be visualised and if uptake changes after     institution of treatment.   "
227643|NCT00831870|"     The purpose of this study is to collect and compare EndoSure and EndoSure s2 Wireless AAA     Pressure Sensor measurements with measurements from CT scan imaging, ultrasound, and other     tests used to measure your AAA sac size and endoleaks following AAA repair, and during     follow-up visits with your physician. An antenna is held over the patient's abdomen to     measure pressure inside the aneurysm sac. The reading does not cause any discomfort, and dye     or radiation is not needed to take the pressure measurement. To qualify, the patient must     have a previously implanted EndoSure Sensor.   "
227644|NCT00831883|"     The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction     intervention for currently or recently incarcerated adolescents who report problematic     substance use.   "
246078|NCT01065194|"     The purpose of this study is to compare the effects of a pulsed application of Levosimendan     versus placebo on the composite end-point functional capacity and quality of life.   "
227646|NCT00831909|"     To provide accurate and reliable information regarding NSCLC clinical management across     European countries in order to detect unmet medical needs of this disease in terms of:     patient and hospital characteristics; diagnostic and treatment approaches: initial and     subsequent, follow-up patterns in clinical management; outcomes: symptoms, death,     functionality, quality of life; use of resources and burden on patients and health care     systems.   "
227647|NCT00831922|"     The objective of this study is to evaluate the activity of 2 oral doses of AB1010 in subjects     suffering from active RA who have shown an inadequate response to one DMARD including MTX or     anti-TNF, after 3 months (12 weeks) of treatment.      The safety and efficacy will be evaluated on:      Rate of patients achieving ACR 20, 50, 70 and 90 DAS (disease activity score) after 3 months     treatment ACRn after 3 months treatment Therapeutic maintenance of AB1010 at 3 months Quality     of Life assessed by SF12 Health Assessment Questionnaire (HAQ) Clinical and biological safety     Pharmacokinetic profile of AB1010   "
227771|NCT00834236|"     No accurate, inexpensive and non-invasive test for gastric cancer screening is currently     available. The investigators' recent study identified a1-antitrypsin and other proteins as     potential biomarkers of gastric cancer in gastric juice. The aim of this study was to develop     a novel non-invasive modality for detecting gastric cancer by measurement of biomarkers in     gastric juice.   "
227648|NCT00831935|"     The purpose of this study is to test a new monitoring technology that uses the sound of a     depressed person's speech to assess the severity of depression symptoms. The Vocal Social     Signals Platform (VSSP) is software that analyzes the non-verbal characteristics of a     person's speech. This study will test this software to see if it could be a useful     measurement tool for assessing depression symptoms. Participation in this study requires     coming to the research headquarters twice over a three-month period. The first visit is to     determine eligibility. Throughout the study, participants will be connected to a telephone     system five times, on which they will answer questions about their depression symptoms. After     answering questions, their voice will be recorded using a structured speech sample that the     participant will read out loud. The participant will also give an unstructured speech sample,     which will involve describing a typical day or the last movie s/he saw. The voice samples     will be analyzed and compared to the results of the depression symptom questionnaires.   "
227649|NCT00831948|"     Mitochondrial diseases are a heterogeneous group caused by genetic defects in mitochondrial     DNA or in nuclear genes. POLG is the most frequently involved gene in mtDNA instability     diseases resulting in mtDNA multiple deletion and/or depletion. It encodes the DNA polymerase     gamma (POLγ), the only known DNA polymerase found in mammalian mitochondria. Mutations in     POLG could explain 45% of familial progressive external ophtalmoplegia associated with     multiple mtDNA deletions. However, in more than 70%, the analysis of the genes involved in     mtDNA instability remains unsuccessful.      To date, these genes are screened by sequencing methods that are not able to detect     large-scale rearrangements. In order to detect possible large-scale rearrangements, the     investigators propose to develop a new assay based on QMPSF (Quantitative Multiplex PCR of     Short fluorescent Fragments) able to detect exon deletions and duplications. the     investigators propose to screen the POLG gene by QMPSF in at least twenty patients with     either no mutation or only one mutation detected in POLG and no mutation in other genes such     as TWINKLE and ANT1.      This study would allow the investigators to know if large-scale rearrangements occur in the     POLG gene and to estimate their frequency in patients with mtDNA instability. These data are     important to know if the sequencing analysis of POLG should be completed by the screening for     partial deletions and duplications to ensure an accurate molecular diagnosis of these     syndromes. Moreover, this method could be extended to ANT1 and TWINKLE genes.   "
227650|NCT00831961|"     Repeated exposure to topical antibiotics may alter the normal bacteria on the eye and in the     nose and increase rates of resistance. This study will determine whether repeated short-term     exposure to topical antibiotic drops which are commonly prescribed after eye injections to     reduce the chance of infection increase rates of resistant bacteria which are normally found     on the eye and in the nose.      We hypothesis that certain commercially available antibiotics may increase rates of bacteria     resistance more so than others.   "
227651|NCT00831974|"     This is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of AB1010 in     patients suffering from indolent systemic mastocytosis with handicap.   "
227652|NCT00832663|"     The purpose of this study is to determine the influence of non-steroidal anti-inflammatory     drugs (NSAIDs) on muscle regeneration.      The investigators' hypothesis is that ingestion of NSAID will delay or impair muscle     regeneration.   "
227653|NCT00832676|"     Inflammatory arthritis (IA) is a major cause of long-term disability. Due to specialist     shortages, failure of primary care providers and individuals to recognize the disease, and     lack of awareness of the importance of early intervention, delays to rheumatologic care are     common. Peer support models have been used for various health issues and may be one method to     assist individuals with early IA to manage their disease and cope with stress. Qualitative     research methods (focus groups) will seek out feedback on a peer support approach and explore     the learning needs (informational needs, educational preferences) and opinions about     emotional and appraisal support of individuals living with IA, from the perspectives of     patients. The data will be analyzed and expressed themes (articulated needs and     understandings of interviewee context) will guide the future development of a peer support     intervention.   "
227654|NCT00832689|"     The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local     control of cancer and prolong survival in patients with inoperable biliary tract cancer.   "
227680|NCT00833053|"     Participants from an ongoing observational study (P05319) who have a limited (adequate but     less than optimal) response to infliximab will be randomized to either increase the frequency     of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to     their current treatment plan. While receiving infliximab study treatment(s), patients in this     study will attend regularly scheduled office visits for various clinical tests for safety and     effectiveness evaluations.   "
227681|NCT00833066|"     The purpose of this study is to determine whether the oral administration of grass pollen     peptides is safe and effective in the treatment of allergic rhinitis.   "
227682|NCT00833079|"     The primary objectives are to establish the therapeutic equivalence of tacrolimus ointment     0.1%, manufactured by Taro Pharmaceuticals Inc. and Protopic® (tacrolimus), 0.1% topical     ointment (Astellas Pharma US, Inc.) and to show superiority over vehicle in the treatment of     moderate to severe atopic dermatitis.      The secondary objectives are to compare the adverse event (AE) profiles of the two ointments     and to investigate their systemic absorption at steady state.   "
227685|NCT00833118|"     This protocol seeks to determine the efficacy and reliability of a simple maneuver, the jaw     thrust maneuver, in addition to cricoid pressure, in improving visualization of airway     anatomy during video laryngoscopy. Hypothesis: The grade of view of the glottis as determined     by the modified Cormack and Lehane grading system in anesthetized patients will improve by     performing a jaw thrust maneuver during video laryngoscopy with compared with video     laryngoscopy alone. Similarly, the grade of the view during cricoid pressure will also     improve with a jaw thrust maneuver.   "
227686|NCT00833131|"     The addition of Oxaliplatin to conventionally fractionated chemoradiation (FULV or     capecitabine) is considered as standard in unresectable rectal cancer by the panel of     experts. The Investigators addressed the question whether short-course preoperative     radiotherapy with consolidating chemotherapy of FOLFOX4 may increase the rate of R0 resection     in patients with unresectable rectal cancer.   "
250950|NCT01140542|"     This study is a proof of concept study to confirm in a standardized manner the therapeutic     efficacy of roflumilast in type 2 diabetes mellitus patients.   "
227655|NCT00832702|"     This research study is designed to investigate the approaches to noninvasive detection and     assessment of coronary vascular dysfunction in women by comparing the testing results from     the invasive standard care diagnostic procedure Angiogram and from the additional noninvasive     diagnostic procedure CMR Imaging. The investigators want to specifically study 375 female     patients who have signs or symptoms suggestive of heart disease but don't have obstructive     coronary artery disease. Two study sites (Cedars-Sinai Medical Center and University of     Florida) are recruiting participants.      The standard of care procedures include demographics, review of recent clinical symptoms,     review of medications being taken, a physical exam, pre-angiogram blood collection, chest     x-ray, ECG and heart angiogram. The research procedures for this study are the cold pressor     testing, blood/urine collection, health questionnaire, the post-angiogram ECG and cardiac     MRI.      Patients will be asked to undergo heart angiogram testing to test for abnormalities in their     heart arteries. If the heart angiogram shows that the patients do not have blockages in major     heart arteries, then the patients will have coronary flow reserve measurement test (as part     of the heart angiogram) to determine whether the patients have abnormally functioning of the     small heart arteries. This test will be performed by infusing the three drugs: adenosine,     acetylcholine and nitroglycerin. The three drugs are naturally occurring substances and have     been used for routine heart angiograms.      Cardiac Magnetic Resonance (CMR) imaging may help us more easily and non-invasively detect     abnormalities in the inner layer of the heart muscle resulting from the abnormal function of     the heart arteries. All the 375 participants will undergo baseline CMR imaging test and a     subgroup of 200 participants will undergo a second CMR imaging test at their at least 1-year     followup visit.      Patients will be followed up using phone questionnaires at 6 weeks, 6 months for 5 years, and     than annually for 20 years thereafter. Other procedures in this study include obtaining     informed consent, review of demographics, physical examination, ECG, blood and urine tests,     clinical symptoms, medications, questionnaires, etc. The core laboratories include Blood,     Lipoprotein, Chemistry Core Lab, Reproductive Hormone Core Lab, Inflammatory Marker Core Lab,     Oxidative Stress Core Lab, and Angiographic Core Lab. Additionally, GCRC at Cedars Sinai will     process, store and ship samples as needed/required.   "
227656|NCT00832715|"     The goal of this clinical research study is to learn how accurately an endobronchial     ultrasound transbronchial needle aspiration (EBUS -TBNA) may detect mediastinal lymph node     metastases in patients with clinical stage I and II non-small cell lung cancer (NSCLC).   "
227657|NCT00832728|"     This is a multicenter, open-label, randomized, concurrent control study of subjects with FHF.     Subjects meeting the eligibility requirements of the study will be randomly assigned in a 2:1     ratio to receive either standard medical therapy for FHF plus the ELAD® system, or standard     medical therapy alone, with the latter defined as conventional therapy for FHF determined to     be clinically appropriate by the treating physician.   "
227658|NCT00832741|"     The purpose of this study is to investigate whether secretion of incretin hormones is intact     and to what extent endogenous as well as exogenous GLP-1 controls postprandial glucose     excursions in patients with type-1 diabetes mellitus.   "
227659|NCT00832754|"     Effective use of Rapid Diagnostic Test (RDT) and artemisinin-based combination therapy (ACT)     depends on the accuracy and safety of RDT based treatment practices and on factors related to     the health delivery system. We propose to study the accuracy and safety of RDT based     diagnosis and treatment of febrile illness, health system determinants of effective use of     RDTs and the public health outcomes of RDT based ACT for malaria.A cluster randomised trial     of RDT based versus clinical judgment based treatment of febrile illness on the incidence of     malaria in <48 month old children will be conducted. Health Centres will be randomly     allocated to RDT based treatment or clinical judgment based treatment arm and children under     2years of age from the catchment area of each health centre will be followed for 2 years. The     cost effectiveness of RDT based approach will be compare with the clinical judgement based     treatment.   "
227660|NCT00832767|"     The objectives of this trial are:        1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic          Cholecystectomy        2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC          to objectively document the scientific merit and the perceived advantages of SILS™ Port          Laparoscopic Cholecystectomy.   "
227661|NCT00832780|"     The purpose of this study is to determine the response of lung tumors to radiation therapy.     This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a     relatively new kind of therapy which is able to focus a large amount of radiation to a small     area with relatively less radiation to the surrounding non-cancerous part of the organ. This     study is being done to find out if this technique is able to control the cancer better or not     than the standard radiation and also to study its safety.   "
227662|NCT00832793|"     Inflammatory arthritis (IA) is a major cause of long-term disability. Due to specialist     shortages, failure of primary care providers and individuals to recognize the disease, and     lack of awareness of the importance of early intervention, delays to rheumatologic care are     common. Peer support models have been used for various health issues and may be one method to     assist individuals with early IA to manage their disease and cope with stress. Qualitative     research methods (one-on-one interviews) will seek out feedback on a peer support approach     and explore the learning needs (informational needs, educational preferences) and opinions     about emotional and appraisal support of individuals living with IA, from the perspectives of     health care providers. The data will be analyzed and expressed themes (articulated needs and     understandings of interviewee context) will guide the future development of a peer support     intervention   "
227663|NCT00832806|"     The goal of this study is to provide you with an effective treatment for reducing the     physical and emotional stress that can occur during the early phase of being without     cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will     receive counseling and a supply of Champix, a medication to help suppress the symptoms of     nicotine withdrawal.      Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking     cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant     increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of     varenicline (Champix) and IVR treatment.   "
227664|NCT00832819|"     The purpose of this study is to determined the maximum tolerated dose (MTD), safety and     tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered     continually twice daily in combination with carboplatin and paclitaxel to patients with     advanced or metastatic non-small cell lung cancer.   "
227665|NCT00832832|"     This research is being done to determine if closing your eyelids after you take your glaucoma     drops makes them more effective in lowering your eye pressure, and to determine if closing     your eyelids for 5 minutes is better than closing them for one minute   "
227683|NCT00833092|"     Insomnia is not a natural part of aging but is higher in older adults because of a variety of     factors common in later life. One of these factors may be a deficient magnesium status. This     study will look at whether or not magnesium supplementation will improve sleep.   "
255628|NCT02874664|"     Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization     in subjects with small cell lung cancer (SCLC).   "
227666|NCT00832845|"     Schizophrenia is associated with significant cognitive and functional deficits. As patients     with schizophrenia grow older, the impact of these deficits at a personal and public health     level is likely to increase. Cognitive Behavioral and Social Skills Training (CBSST) is a     recently developed group therapy that increased the frequency of social activities among     middle-aged patients with schizophrenia. It also increased cognitive insight, a measure of     the ability to reduce confidence in aberrant beliefs. To date, CBSST has not been studied in     late-life schizophrenia. In addition, its impact on medications management, an instrumental     function that is particularly salient in late life, and its interactions with cognition are     largely unknown. Thus, we propose to study the efficacy of CBSST in improving social skills     and medications management in patients with late-life schizophrenia, and to study the     interactions between the patients' cognitive characteristics and their response to CBSST.      Previous studies show that cognitive deficits are strong predictors of response to CBSST.     Cognitive Remediation Treatments (CRTs) have been shown to improve cognition in patients with     schizophrenia especially when combined with psychosocial interventions that focus on function     such as CBSST. Thus, we also propose to assess the tolerability and impact of CRT on patients     with late-life schizophrenia.   "
227667|NCT00832871|"     The purpose of this study is to see if mifepristone prevents worsening of your cancer.     Mifepristone is an antiprogesterone agent, a drug which blocks female hormones, that is     commonly used for the termination of pregnancies. It has not been approved by the Food and     Drug Administration for use in the treatment of cancer. It is unlicensed in the United States     for your condition. However, previous work has indicated that mifepristone may be useful due     to how it works. It is being made available for use in the United States for compassionate     use through the Feminist Majority Foundation.   "
227668|NCT00832884|"     To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35     years old, inclusive, who are either unable to take oral medication or require intravenous     administration of IV Lacosamide.   "
227669|NCT00832897|"     The purpose of this study is to postpone the corneal transplantation in keratoconus and     promote the stiffness of the cornea across the riboflavin-UVA corneal collagen crosslinking ,     and after, corneal ring surgery.   "
227670|NCT00832910|"     Investigate body image of patients with rheumatoid arthritis, correlating with self-esteem,     function and quality of life.   "
227671|NCT00832923|"     The overall aim of this study will be to perform a prospective randomized clinical trial of     an enhanced version of the IMPACT DC intervention involving short-term case management to     facilitate PCP follow-up appointments and to provide education for parents about how to     communicate more effectively with their children's PCPs as a means (1) to improve the rate of     utilization of primary care services for ongoing asthma care and (2) to enhance the     self-efficacy of parents in their interactions with their children's provider regarding the     child's asthma care needs in 150 parents of high risk children referred within the IMPACT DC     Asthma Clinic.   "
227672|NCT00832949|"     Inflammatory arthritis (IA) is a major cause of long-term disability. Due to specialist     shortages, failure of primary care providers and individuals to recognize the disease, and     lack of awareness of the importance of early intervention, delays to rheumatologic care are     common. Peer support models have been used for various health issues and may be one method to     assist individuals with early IA to manage their disease and cope with stress. Qualitative     research methods (one-on-one interviews) will seek out feedback on a peer support approach     and explore the learning needs (informational needs, educational preferences) and opinions     about emotional and appraisal support of individuals living with IA, from the perspectives of     patients. The data will be analyzed and expressed themes (articulated needs and     understandings of interviewee context) will guide the future development of a peer support     intervention.   "
227673|NCT00832962|"     The study is divided in two sub-studies. The first one is an economical and performance     comparison between two antenatal management strategies of RhD negative pregnant women: the     first one will comprise non invasive RhD fetal typing during the second trimester of     pregnancy (GENIFERH 1 RhD typing group), and the second will be a conventional management,     i.e. without RHD fetal typing (GENIFERH 1 control group). The two groups will consist of 13     maternity wards spread over French territory. The second study (GENIFERH 2) is an evaluation     of RhD fetal typing diagnostic performance and biological feasibility in routine antenatal     practice with development of knew technical support; it will be based on more than 3500 fetal     genotypings performed during one year by the five laboratories participating at the two     studies.   "
227674|NCT00832975|"     The purpose of this observational study is to collect data regarding the population of     patients implanted with St. Jude Medical ICD.   "
227675|NCT00832988|"     The primary objective of this study is to evaluate the efficacy of the automated data     collection in the Zephyr device as compared to manual testing results for atrial and     ventricular pacing thresholds. The secondary objectives include: to compare the in-clinic     time needed to retrieve and document the automated device measurements for all tests to the     additional time needed to manually measure sensing, impedance and thresholds for the same     patient; to compare the accuracy of the automated device test results to manual testing     results; evaluate the percentage of patients who are recommended for ACapTM Confirm     utilization.      The Primary Hypotheses are:        1. The values reported from ACapTM Confirm will be within 0.125 V of the value that is          obtained manually in clinic.        2. The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value          that is obtained manually in clinic.   "
227676|NCT00833001|"     The purpose of this study is to evaluate the clinical performance of the PROLIFT system with     a new lighter-weight mesh in repair of vaginal prolapse.   "
227677|NCT00833014|"     The device is a dynamic annuloplasty ring/band that is able to be adjusted in order to     correct for mitral regurgitation intraoperatively or postoperatively, off-pump.   "
227678|NCT00833027|"     Canadian physicians to experience in real life clinical practice the efficacy and     tolerability of adding sitagliptin to their patients who have their glycemic levels     inadequately controlled while on metformin   "
227679|NCT00833040|"     The purpose of this research study was to evaluate ARX-F02 (Sufentanil NanoTab) versus     placebo (sugar pill or inactive substance) in the management of breakthrough pain in cancer     patients.   "
227687|NCT00833144|"     Patients often arrive to the Emergency Department with the chief complaint of shortness of     breath. The cause of the shortness of breath may be due to many things, such as pneumonia,     emphysema, a heart attack, heart failure, and others. It is often very difficult for the     physician to determine the cause of the shortness of breath in the first two hours in the     Emergency Department. This ambiguity makes treating the patient very difficult. Although a     patient could benefit from treatment upon arrival, the emergent treatment of the condition     must wait until a final diagnosis is made.      Recently, emergency physicians have been using portable ultrasound at the patient's bedside     to diagnose numerous conditions, including trauma, blood clots, kidney stones, etc. Recent     research suggests that heart failure, one of the causes of shortness of breath, may be     diagnosed within 5 minutes or less using ultrasound. Most of these studies come from the     intensive care and cardiology. However, no research has yet been performed to determine if     emergency physicians can effectively use ultrasound to quickly diagnose and treat heart     failure within the first few minutes of a patient's arrival to the emergency department. The     hypothesis of this study is to evaluate the ability of residents in emergency medicine to use     ultrasound to diagnose patients in heart failure who presented with the chief complaint of     shortness of breath. The final diagnosis of the patient upon discharge from the hospital will     be compared to the preliminary diagnosis based on the portable ultrasound findings.   "
227688|NCT00833157|"     The investigators will investigate the effect of glucosamine or ibuprofen combined with 12     weeks of muscle strength-training in patients with knee-osteoarthritis.      The investigators would like to elucidate whether treatment with glucosamine or NSAID     interact with the effects of exercise in osteoarthritis patients.   "
227689|NCT00833170|"     The purpose of the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry     is to study the contemporary natural history of children <16 years of age newly diagnosed     with inflammatory bowel disease. The project follows these children quarterly from diagnosis     examining clinical, laboratory, and humanistic outcomes. Genetic and serologic monitoring is     performed on the study population.   "
227690|NCT00833183|"     A study of safety and efficacy of topical methyaminlevulinate 80mg/g with and without     occlusion followed by red light exposure in subjects with facial acne.   "
227691|NCT00833196|"     A post marketing, international, multicenter, observational, prospective, longitudinal study.     The purpose of the study is to describe cervical dystonia sub-types with their injection     protocols and response to BoNT-A.   "
227692|NCT00833209|"     Medication Overuse Headache (MOH) is an illness affecting about 1,5 % of the general     population. It is characterized by chronic headache occurring for at least 15 days a month,     by a use of antimigraine drugs during at least 3 months for more than 10 days a month (for     ergots, triptans, opiate derivates and combined analgesics) or for more than 15 days a month     (for simple analgesics). The chronic headache must have occurred during the period of     antimigraine drug abuse and the headache must have returned to its episodical pattern after     withdrawal of antimigraine drugs. But, about 50% of the MOH patients will relapse during the     first year following the antimigraine drugs withdrawal.      The pathophysiology of MOH is still largely unknown, and the role of antimigraine drug abuse     in the transformation from migraine through MOH is not fully understood.   "
227693|NCT00833222|"     The purpose of this study is to test the feasibility of measuring body composition by air     displacement plethysmography (ADP) in rapidly growing, medically stable late gestation [32-35     weeks post-menstrual age (PMA)] premature infants.   "
227694|NCT00833235|"     This is a multi-center, prospective, controlled, observational study of the natural history     of patients with dry eye disease.   "
227695|NCT00833248|"     The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in     terms of reducing the size of the prostate volume in prostate cancer patients who were     scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to     receiving radiotherapy, it is recommended that patients with intermediate to high risk     prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is     known to reduce the size of the prostate and thereby decrease the required radiation field     and enable a more safe and effective treatment. In this trial, participants were randomly     selected (like flipping a coin) to receive either degarelix given alone or a standard hormone     therapy (combination of goserelin and bicalutamide. The treatment was given for three months     and the prostate size was measured by ultra sound at the beginning and at the end of the     trial. The participants were required to come to the clinic for 5 or 6 visits during the     three months.   "
227707|NCT00833404|"     This is a 12-week clinical trial investigating the effects of smoking cessation on sexual     functioning in men. This study consists of 3 sessions and provides 8 weeks of free nicotine     transdermal patches. It is hypothesized that men who quit smoking, compared to men who smoke     as usual, will demonstrate improved sexual functioning, measured both physiologically     (erectile functioning) and subjectively (self-reported sexual functioning).   "
227696|NCT00833261|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together     with radiation therapy works in treating patients with recurrent head and neck cancer.   "
227697|NCT00833274|"     Apathy, defined as a lack of motivation in behaviour, cognition and affect, is common in     neurodegenerative diseases. Specific scales are available for the evaluation of apathy but it     lacks objective evaluation methods.      The aim of this study is to evaluate the changes in reaction time task according to the     presence or absence of reward stimulation and to assess the relation between these     performances and apathy scales.   "
227772|NCT00834249|"     The objective of this study is to compare the rate and extent of absorption of venlafaxine 25     mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fed     conditions.   "
256209|NCT00871637|"     Airway macrophage impairment is a central feature in the immunopathogenesis of chronic     obstructive pulmonary disease, regardless of smoking status.   "
227698|NCT00833287|"     Patient who have major traumatic injury are at risk to develop postoperative inflammatory     complications such as pneumonia and lung trouble called adult respiratory distress syndrome     (ARDS). This study will draw blood from trauma patients are several time points after their     injury to see if we can predict who is at greatest risk for developing pneumonia or ARDS     based upon the results of these immune lab tests. We are particularly interested to see if     this will be useful in obese patients who have a greater risk of these post trauma     complications   "
227699|NCT00833300|"     The purpose of this randomized clinical trial is to determine whether haloperidol is superior     to olanzapine for the treatment of ICU acquired delirium. The hypothesis is that haloperidol     is in fact superior to olanzapine in treating ICU acquired delirium and sustaining delirium     free time.   "
227700|NCT00833313|"     Atrial fibrillation is a type of irregular heartbeat that is common after having heart     surgery. There may be many different reasons why some people get atrial fibrillation after     their heart surgery. These reasons may include that a person is older or that he/she is     taking certain types of medications before surgery. Genes may also be a reason. Genes contain     the material passed from parent to child that determines the make-up of the body and mind.     For example, some genes control the color of your hair or eyes. Some people may have genes     that make it more likely for them to get atrial fibrillation after their heart surgery. This     research project is being done to find out if the cells of people who develop atrial     fibrillation after heart surgery are different from the cells in people who do not develop     atrial fibrillation after surgery.   "
227701|NCT00833326|"     This is a Phase 1 study during which patients with advanced/metastatic solid tumors will     receive investigational study drug ARRY-334543 and docetaxel (with prophylactic growth factor     support). Patients will receive increasing doses of study drug in combination with docetaxel     in order to achieve the highest dose of study drug possible that will not cause unacceptable     side effects. Patients will be followed to see what side effects the combination causes and     what effectiveness the combination has, if any, in treating the cancer. Approximately 30     patients from the US will be enrolled in this study.   "
227702|NCT00833339|"     The investigators propose to conduct a randomized double-blind, parallel-group,     placebo-controlled trial of mifepristone in veterans with military-related posttraumatic     stress disorder (PTSD). This study will examine the clinical, neuropsychological, and     neuroendocrine effects of short-term treatment of mifepristone (600 mg/day for one week) to     determine if this treatment is efficacious in improving PTSD symptoms, cognitive functioning,     or other related clinical measures. Additionally, the investigators will observe whether     baseline neuroendocrine activity, or other clinical or neuropsychological factors predict the     response to mifepristone, and whether mifepristone-induced changes in neuroendocrine activity     are associated with treatment outcome.   "
227703|NCT00833352|"     This prospective, randomized, single blind, multi-centre study will examine the effect of the     right ventricular (RV) lead location in patients implanted with a cardiac resynchronization     defibrillator.        1. Purpose :           To compare the effect of RV mid-septal (RVS) versus RV apical (RVA) lead location on          left ventricular reverse remodeling in patients indicated for cardiac resynchronization          therapy device (CRT-D) over a period of 6 months and to evaluate the clinical outcome of          the RVS versus RVA pacing, over a period of 12 months.        2. Objectives:      The primary objective is to demonstrate that there is no difference between the two groups     (RVA vs. RVS) in the change of left ventricular end systolic volume (LVESV), between baseline     and 6 months.      The secondary objectives are to evaluate the percentage of echo-responders plus additional     clinical and safety outcomes.      This prospective, randomized, multi-centre, single-blind with 2 parallel arms,     non-inferiority study will be conducted in approximately 25 study centres in Europe. The     patients will be randomized in a 1:1 ratio. A maximum of 416 patients will be enrolled in     this study.      All eligible patients will be followed through baseline, randomisation, pre discharge, 1, 6     and 12 months post-implant. Enrolment is expected to be completed in 18 months. The total     duration of the study is expected to be approximately 30 months.   "
227704|NCT00833365|"     The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early     vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a     higher PDA closure rate than later use of Ibu. Early use is defined as medication given     before the infant reaches 96 hrs old. Late use is defined as medication given when infant is     more than 96 hrs old.   "
227705|NCT00833378|"     This is a Phase I, open-label, single sequence, crossover study to be conducted in healthy     adult subjects. There will be a screening visit, three treatment periods, and a follow-up     visit. In Period 1, subjects will receive a single dose of eltrombopag on Day 1, and PK     sampling will occur for 72 hours. In Period 2, subjects will receive LPV/RTV for 14 days with     PK sampling for 12 hours. In Period 3, subjects will receive a single dose of eltrombopag     with LPV/RTV on Day 1 only with PK sampling for 72 hours. Subjects will return for a     follow-up visit within 10 to 14 days of the last dose of study drugs.   "
227706|NCT00833391|"     The purpose of this study is to evaluate the relative drug concentrations achieved with     different formulations of GSK1838262 in healthy volunteers.   "
227708|NCT00833417|"     This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the     efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma.     All patients received vismodegib until evidence of progression, intolerable toxicities most     probably attributable to vismodegib, or withdrawal from the study.   "
227709|NCT00833430|"     Long-term follow-up of IDE patients for publication   "
227739|NCT00833820|"     The investigators' preliminary studies demonstrated that repetitive transcranial magnetic     stimulation (rTMS) of the brain may determine a slight slowing in the rate of disease     progression in ALS patients (Di Lazzaro et al 2004, 2006). The aim of this study is to     investigate whether rTMS of the motor cortex performed over a long period of time (12 months)     in a group of patients with ALS, can have a more pronounced beneficial effect. The     investigators will compare the disease progression in two groups of patients: the first group     of patients will be treated with real rTMS (one week daily treatment every month) and the     second group of patients will be treated with sham (placebo) rTMS.   "
245059|NCT01068561|"     The purpose of this study is to evaluate the short-term safety of a single intravitreal     injection of autologous bone marrow stem cells in patients with retinitis pigmentosa.   "
227710|NCT00833443|"     Currently there are no medications approved for the treatment of methamphetamine addiction.     Bupropion is an antidepressant that is approved by the Food and Drug Administration (FDA) for     the treatment of depression and for cigarette smoking cessation but is not approved by the     FDA for the treatment of methamphetamine addiction. Preliminary research studies suggest that     bupropion may help people receiving treatment for methamphetamine addiction to reduce or to     stop their methamphetamine use. But results of these studies also suggest that bupropion may     help certain groups of patients more than others, such as men versus women and light versus     heavy methamphetamine users, although the reasons for this difference are not known. One     possibility is that a person's genetic make up may influence whether or not they respond to     treatment with bupropion for methamphetamine addiction.      The purpose of the study is to determine if bupropion is can help people reduce or stop their     methamphetamine use and to investigate whether genetic variations influence whether people     respond to treatment with bupropion for methamphetamine addiction, which may help doctors and     patients better decide if treatment with bupropion will be beneficial or not. To identify     possible genetic variations that influence response to bupropion, we will perform genetic     tests on blood or saliva specimens from participants receiving treatment with either     bupropion or placebo (which is a pill that contains no medication) in conjunction with     standard cognitive behavioral therapy drug counseling. We will compare methamphetamine use,     as assessed with urine drug screens, among participants receiving bupropion versus those     receiving placebo to determine if bupropion helps people to reduce or stop their     methamphetamine use. We will then compare the results of the genetic tests among participants     who respond and who do not respond to bupropion. In addition, since the amount of     methamphetamine a person uses was associated with response to bupropion in preliminary     studies, we will also compare the results of genetic testing among persons with heavy versus     light methamphetamine use before entering treatment.      Results of this study have the potential to provide insights into the biology of     methamphetamine addiction and help increase the understanding of how bupropion works. This     information could be useful to develop effective medications for methamphetamine addiction     and to improve the ability of clinicians to provide treatment to patients with     methamphetamine addiction.   "
227711|NCT00833456|"     The purpose of the study is to monitor the general functional changes among patients with     schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6     months.The primary study objective is to compare general functioning of patients with     schizophrenia treated with Seroquel SR between baseline and the last study visit. The     secondary study objectives are to compare general functioning of patients with schizophrenia     treated with other atypical antipsychotic medicinal products administered once daily between     baseline and the last study visit, monitoring of other indicators of clinical improvement,     evaluation of patient compliance and assessment of occurrence of adverse effects   "
227712|NCT00833469|"     The purpose of this study is to determine whether women with postpartum major depressive     disorder (MDD) will experience a significant decrease in depressive symptoms from baseline     over an eight-week treatment intervention with escitalopram (Lexapro). Also, to determine     whether women with postpartum MDD will experience a significant decrease in anxiety symptoms.   "
227713|NCT00833482|"     This study assesses the effects of voriconazole, 200 mg, administered twice daily (BID), on     the steady-state pharmacokinetics of atazanavir administered as atazanavir/ritonavir, 300/100     mg once daily (QD), in healthy participants with functional CYP2C19 alleles. The study also     reviews the effects of atazanavir/ritonavir, 300/100 mg QD, on the pharmacokinetics of     voriconazole, 200 mg, BID in healthy participants with functional CYP2C19 alleles.   "
227714|NCT00833495|"     This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up     to 5 sites. The purpose of this study is to determine how effective the combination of Pred     Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the     prevention of eye allergies. Study subjects will be randomized to one of the following:        -  FOV1101-00 concentration 1 and Pred Mild®        -  FOV1101-00 concentration 2 and Pred Mild®        -  Vehicle of FOV1101-00 and Pred Forte®        -  Vehicle of FOV1101-00 and Vehicle of FOV1101-00   "
227715|NCT00833508|"     This study will investigate the effect of preoperative chemoradiotherapy on exercise capacity     as measured by cardiopulmonary exercise testing in patients with colorectal cancer.   "
227716|NCT00833521|"     The objective of this study is to compare the relative bioavailability of Zolpidem tartrate     10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA     Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle & Co.) in healthy, adult,     non-smoking subjects under fasting conditions.   "
227717|NCT00833534|"     RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in     different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab,     can block cancer growth in different ways. Some block the ability of cancer cells to grow and     spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. It is not yet known whether lenalidomide is more effective with or without rituximab in     treating chronic lymphocytic leukemia or small lymphocytic lymphoma.      PURPOSE: This phase II trial is studying how well lenalidomide works when given with or     without rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic     lymphoma who have undergone autologous or syngeneic stem cell transplant.   "
227718|NCT00833547|"     This study will determine whether eszopiclone will normalize sleep patterns and restore     sleep-dependent enhancement of motor skill learning in patients with schizophrenia. The     investigators will compare subjects taking a placebo to those taking 3 mg of eszopiclone with     regard to: sleep architecture and sleep latency as measured by actigraphy and polysomnography     and sleep-dependent motor skill learning.   "
227719|NCT00833560|"     The purpose of this study is to evaluate the safety and effectiveness of bortezomib in     combination with a standard regimen of cyclophosphamide and dexamethasone.   "
227720|NCT00833573|"     To describe GERD digestive expression according to ages: - children (from 0 to 23 months) and     (24 months and more)- adults (from 18 to 29 years old), (from 30 to 39 years old), (from 40     to 49 years old), (from 50 to 59 years old), (more than 60 years old)   "
227721|NCT00833586|"     The purpose of this study is to evaluate the relative bioavailability of the test formulation     of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis     Pharmaceuticals), under fasted conditions in healthy, non-tobacco using male and female adult     subjects.   "
227722|NCT00833599|"     The purpose of this study is to demonstrate the feasibility of near-infrared fluorescence     imaging in subjects with acquired or hereditary lymphedema, in subjects with lymphovascular     disorders and in normal health subjects; in order to attempt to correlate imaging     phenotype(s) with genotype(s).   "
227723|NCT00833612|"     Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased     MI size.   "
227724|NCT00833625|"     The goal of this clinical research study is to learn if the results of a positron emission     tomography/computed tomography (PET/CT) scan done 10-14 days after beginning chemotherapy and     radiation (chemoradiation) can predict how a patient with cancer of the esophagus will     respond to chemoradiation. Researchers also want to learn if biomarkers (substances in the     body associated with cancer) found in tumor tissue can predict response to chemoradiation.   "
227725|NCT00833638|"     The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed     once-a-day.   "
227726|NCT00833651|"     Influenza (Flu) vaccine is recommended for kidney transplant patients who are at least 6     months post-transplant. The influenza vaccine stimulates the immune system to builds     protective antibodies against the flu virus.      Previous research has shown that adult kidney transplant patients are not able to form as     much of these protective antibodies as compared to healthy volunteers. Research has also     suggested that different immunosuppressive medicines may have different effects on antibody     formation. In this study, we hope to evaluate these differences in more detail.      In recent years, increasingly effective, but also increasingly complex, immunosuppressive     regimens have been developed, however, there has been little detailed systematic study of the     immune changes that occur in response to vaccination with these newer immunosuppressive     regimens.Current policies on vaccination of transplant recipients are generic and continue to     be based on old concepts rather than on any new understanding of the effects of these newer     therapies on the immune system.      We hope to improve our understanding of the effects of the immunosuppressive regimens in use     today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) on immune response to flu     vaccine. Such knowledge will be critical to helping clinicians develop strategies for getting     desirable immune responses while not causing rejection.   "
227727|NCT00833664|"     The Purpose of this study os to evaluate the relative bioavailability of the test formulation     of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis     Pharmaceuticals), under post-prandial conditions in healthy, non-tobacco using male and     female adult subjects.   "
227728|NCT00833677|"     The proposed project is part of a program of research to improve management of type 2     diabetes (T2DM) through a community-academic partnership that addresses cultural factors in     disease management. Specific aims are to: 1. Strengthen a community-academic partnership with     the immigrant Chinese community in San Francisco to improve diabetes management; 2. Adapt and     test a behavioral diabetes intervention, Coping Skills Training, to addresses family and     cultural issues in immigrant Chinese patients with T2DM; and 3. Disseminate the adapted     Coping Skills Training Program findings via the community-academic partnership to the     immigrant Chinese American community through service programs, ethnic media, and     professional/scientific publications. A mixed-methods CBPR approach will be used to     interpretively adapt a behavioral intervention to be culturally appropriate, and test its     efficacy using a repeated measures design. Two historically significant social service and     health agencies serving immigrant Chinese in San Francisco are collaborating with this     nurse-led interdisciplinary research team.   "
227729|NCT00833690|"     The purpose of this study is to determine the safety and tolerability of inosine and its     ability to raise urate levels in blood and cerebral spinal fluid in individuals with early     Parkinson disease. This will determine whether it is appropriate to proceed with a larger     study of inosine's ability to modify the rate of disability progression in PD.   "
227730|NCT00833703|"     This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or     infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery     shunt.      The primary objective was to assess the safety up to 18 months of age of the extended use of     Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of     age.      The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis     requiring intervention or any death.   "
227731|NCT00833716|"     This trial is conducted in the United States of America (USA). The aim of this clinical trial     is to investigate how different degrees of renal impairment (mild, moderate, severe and     end-stage renal disease) affect the pharmacokinetics of NN9535.   "
227732|NCT00833729|"     To describe the response of etanercept after adalimumab has failed to produce a satisfactory     response in moderate to severe plaque psoriasis. A total of 10 patients with moderate to     severe psoriasis who are currently using adalimumab for at least 12 weeks but have a PGA of     mild or worse will be transitioned to etanercept 50 mg twice weekly (BIW) for 12 wks followed     by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.   "
227733|NCT00833742|"     Objective: Somatization of emotions accounts for excess Emergency department (ED) visits.     Intensive Short-term Dynamic Psychotherapy (ISTDP) has methods to diagnose and manage     somatization. We examined the feasibility, acceptability and effectiveness of ISTDP     diagnostic and treatment methods used for patients with repeated ED presentations for     medically unexplained physical symptoms (MUS)   "
227734|NCT00833755|"     The purpose of this study is to compare pain threshold, pain tolerance, and wind up, as     measured by QST, before and after a single dose of ketamine infusion under two clinical     conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid     therapy.   "
227735|NCT00833768|"     Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this     study at approximately 50 sites within approximately 9 European countries. The purpose of     this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a     safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic     CKD patients not on dialysis. Total length of participation is approximately 24 weeks.   "
227736|NCT00833781|"     The purpose of the study is to find out whether an experimental autologous dendritic cell     vaccine is safe, well tolerated, and whether it can strengthen the immune system's response     to HIV.   "
227737|NCT00833794|"     The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit     of Tramadol OAD tablets versus Placebo.   "
227738|NCT00833807|"     The goal of this clinical research is to find the highest tolerable dose of Abraxane     (nab-paclitaxel) when given directly to the area where the cancer is located. The safety of     this drug will also be studied.   "
246227|NCT01086475|"     The purpose of this study is to determine the effectiveness of D-cycloserine for improving     social impairment in child with pervasive developmental disorders (PDD).   "
227740|NCT00833833|"     The purpose of this study is to determine the maximum tolerated dose and effectiveness of the     study drug (CC-4047) Alone Or in Combination With Low-dose Dexamethasone as treatment for     patients with relapsed and refractory multiple myeloma   "
227773|NCT00834262|"     This study is conducted in Asia. The aim of this observational study is to evaluate the     safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin     Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.   "
227741|NCT00833846|"     Type II diabetes mellitus is rapidly becoming a global pandemic with a deleterious impact on     cardiovascular morbidity and mortality. Understanding its pathophysiology is important for     the development of future therapeutic interventions. Emerging evidence suggests interplay     between mitochondrial dysfunction and the development of insulin resistance. Interestingly,     mitochondrial dysfunction in skeletal muscle and adipose tissue are early events in the     development of type II diabetes mellitus and are proposed to play a role in exacerbating     insulin resistance. Although it has been demonstrated that skeletal muscle of     insulin-resistant individuals has reduced mitochondria and mitochondrial dysfunction, whether     this disruption of mitochondrial function is more widespread has not been explored. We     hypothesize that this disruption of mitochondrial function is more systemic and thereby may     contribute to the development of peripheral insulin resistance and possibly promote the     myriad of complications associated with diabetes.      To test these assumptions, we propose an initial proof of concept study to evaluate     mitochondrial biology in human platelets in normal volunteers, pre-diabetic and diabetic     subjects to assess whether mitochondrial disruption/dysfunction evolves with the progression     to type II diabetes. In parallel, proteomic analysis will be performed to evaluate whether     the development of insulin resistance and diabetes confers a specific modulation in the     biological signature of human platelets with disease progression. To delineate these     concepts, we will evaluate study subject's glucose tolerance and insulin sensitivity and draw     blood in parallel to study their platelets. Biological readouts will include: 1) the     quantification of the mitochondrial proteome and electron transfer chain content; 2) the     evaluation of platelet mitochondrial respiratory function and 3) to determine the     mitochondrial reactive oxygen species capacity and defenses. If this hypothesis is validated,     this study will show that the mitochondrial disruption/dysfunction is a more generalized     finding in type II diabetes. Additionally, it would propose the use of platelets as potential     biomarkers for early detection of mitochondrial function and assessment of disease. Finally,     this would establish a peripheral blood readout of the modification of mitochondrial function     as a novel approach to monitor the prevention and/or reversal of insulin resistance and     diabetes in response to therapeutic strategies.   "
227742|NCT00833859|"     The purpose of this study is to find out if a program of intensive chemotherapy with     gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation     aimed at the patient's tumor followed by more chemotherapy can increase the chances that the     patient's pancreatic tumor can be removed completely.   "
227743|NCT00833872|"     The purpose of this first-in-man trial is to determine the safety and tolerability of     ascending single and multiple doses of LEO 22811 in healthy male subjects as well as to     determine the safety and tolerability of single oral doses of LEO 22811 in healthy female     subjects. The trial will be performed in two parts. In Part 1, single doses of LEO 22811 will     be administered to healthy male and female subjects. In Part 2, multiple doses of LEO 22811     will be administered to healthy male subjects.   "
227744|NCT00833885|"     With this study the investigators will try to assess the tolerability and measurability of     the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual     households. Households with an identified index case of influenza will be randomised into one     of three intervention arms: 1. group, where the household will receive general information     about transmission of influenza virus and means to prevent it (Controls); 2. group, which     will receive surgical masks and be asked to wear them whenever they are in close contact with     the index case or other persons of the household that became ill during the observation     period; 3. group, which will be given and asked to wear surgical masks as well as to execute     intensified hand hygiene.      In addition to assessing the secondary attack rate as our primary outcome measure, the     investigators will also try to evaluate compliance to those interventions by questionnaires.   "
227745|NCT00833898|"     RATIONALE: A stress management intervention may be more effective than usual care in     improving quality of life in caregivers of patients undergoing bone marrow transplant.      PURPOSE: This randomized phase III trial is studying a stress management intervention for     caregivers of patients undergoing bone marrow transplant.   "
227746|NCT00833911|"     The purpose of this study is to collect information regarding the long-term (6 and 12 months)     safety of Tramadol HCl Once-A-Day(OAD) 300 mg.   "
227747|NCT00833924|"     The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by     US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular     Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.   "
227748|NCT00833937|"     The objective of this study is to compare the relative bioavailability of Zolpidem tartrate     10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA     Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle & Co.) in healthy, adult,     non-smoking subjects under non-fasting conditions.   "
227749|NCT00833950|"     Phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or     partial residual inhibition. This technique is based on the theory by Choy advocating that     the induction of a sound wave with a 180 degree phase shift compared to the sound experienced     by the patient could result in sound cancelling, likely by negation of the cortical     perception of tinnitus.      The aim is to determine the efficacy of the Phase Out treatment in pure tone and narrow band     noise tinnitus patients.   "
227750|NCT00833963|"     The MotHER Pregnancy Registry is a United States (U.S.)-based, prospective, observational     cohort study in women with breast cancer who have been or are being treated with a     trastuzumab (herceptin)-containing regimen with or without pertuzumab (perjeta) or     ado-trastuzumab emtansine (kadcyla) during pregnancy or within 7 months prior to conception     (regardless of cancer stage at the time of trastuzumab, pertuzumab, or ado-trastuzumab     emtansine exposure).   "
227751|NCT00833976|"     This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in     subjects who have been on an atypical (second-generation) antipsychotic medication. The     investigators hypotheses are that patients who receive Lovaza will experience a significant     decrease in triglycerides from baseline. Secondary hypotheses include: Patients will     experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.   "
227752|NCT00833989|"     The purpose of this study is to is to test increasing repeat doses of GSK249320 compared to     placebo in patients with stroke.   "
227753|NCT00834002|"     RATIONALE: Vaccines made from a patient's white blood cells (dendritic cells) and a specific     leukemia antigen (Wilms tumor antigen-1) may induce an effective immune response to kill     residual leukemic cells and/or prevent leukemia relapse.      PURPOSE: This phase I/II trial is studying the feasibility, safety and efficacy of     intradermal mRNA-transfected dendritic cell vaccination therapy in patients with acute     myeloid leukemia.   "
227754|NCT00834015|"     The aim of the present study is to analyse the significance of postoperative combined     strength and aerobic training for outcome of the lumbar fusion patients compared to usual     care (patients with isthmic or degenerative spondylolisthesis).   "
227774|NCT00834275|"     The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg     capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules     (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal     healthy non-smoking male and female subjects under fasting conditions.   "
227755|NCT00834028|"     This project will include at least 40 patients with hepatocellular carcinoma (HCC) who will     receive transcatheter arterial chemoembolization (TACE) as a sole method for the management.     The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of     vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are     determined. All patients will be evaluated according to the TNM system for the cancer staging     before and 3 months after each session of treatment. The vascularity of tumor, the drug and     the dose used for embolization, and the area of infarction will be recorded. These data will     be compared with the clinical courses of the patients to obtain the most suitable way in the     management of these patients.   "
227756|NCT00834041|"     This first open-label study in a pediatric population was designed to evaluate aliskiren     safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with     hypertension.   "
227757|NCT00834054|"     Repeated measurements of lung water by single transpulmonary thermodilution during the first     postoperative days following lung transplantation   "
227758|NCT00834067|"     The objective of this study is to compare the relative bioavailability of moexipril HCl/     hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals     USA) with that of UNIRETIC® 15/25 mg tablets (Schwartz Pharma) in healthy, adult, non-smoking     subjects under non-fasting conditions.   "
227759|NCT00834080|"     The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone     (VIVITROL®) when administered over a period of 24 months to health care professionals who     have a history of opioid dependence.   "
227760|NCT00834093|"     The purpose of this research study is to determine how effective and how safe it is to give     an Epstein-Barr Virus (EBV) immunotherapy product to participants with nasopharyngeal     carcinoma (NPC) associated with EBV that has come back or spread to other parts of the     participants body. The EBV immunotherapy product will be made with white blood cells from the     participants blood and takes about 16 weeks to create. This EBV immunotherapy product may     stop cancer cells from growing and cause the tumors to disappear.   "
227761|NCT00834106|"     A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP     vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine     type-specific genital disease among Chinese females between the ages of 20 and 45.   "
227762|NCT00834119|"     This is a Phase 4, non-comparative, open-label, multi-center study. It is designed to     determine the effectiveness of regular intranasal steroid use in alleviating allergic     rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine.     Subjects will receive 200 mcg (2 puffs in each nostril) of mometasone furoate once a day. An     oral antihistamine at the discretion of the physician may be added at Day 28 (Visit 2), if     patients fail to improve nasal symptoms.   "
227763|NCT00834132|"     The objective of this randomized, single-dose, two-way crossover evaluation is to compare the     relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an     equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in     a test population of 24 adult subjects under fed conditions.   "
227764|NCT00834145|"     Mobilization of fluid from the legs with the Normatec pump in patients with right heart     failure, may empty the reservoir in the legs from excessive fluid, enabling fluid overload     to collect there rather than in the liver or in other third spaces. Thus, we hypothesize that     patients will lose weight, feel better, look better, be less prone to infections in their     legs and to congestion of the liver.   "
227765|NCT00834158|"     A primary hepatocellular carcinoma (HCC) is generally regarded as unresectable if the future     liver remnant (FLR)≤40％ of total liver volume in patient with underlying liver disease, such     as hepatitis B. In China, TACE is the most common treatment for these unresectable HCC.     Recently, PVE has been employed to enlarge the FLR of the patients so as to increase the     resectability and surgical safety of major hepatectomies. In order to shut the arterio-portal     shunt in the liver and control the tumor progress TACE sometimes is performed before PVE. In     this study we design a randomized control trial to investigate the efficacy of sequential     TACE and PVE on increasing the resectability of hepatitis B related HCC compared with TACE     alone.   "
227766|NCT00834171|"     Patient charts will be reviewed to evaluate the incidence of intraocular pressure spikes     while on Loteprednol etabonate ophthalmic suspension 0.5%, Loteprednol etabonate (0.5%) and     tobramycin (0.3%)   "
227767|NCT00834184|"     The purpose of this study is to determine if nikkomycin Z is safe when administered at     different dose levels for 14 days. The study will also determine blood levels and urinary     excretion of nikkomycin Z in relation to dose administered. Healthy patients will be eligible     to participate and will be allocated to receive nikkomycin Z (various doses) or a placebo.   "
227768|NCT00834197|"     This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg     Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries,     Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally     Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc. following a single     oral dose (1 x 15 mg) in healthy adult subjects under non-fasting conditions.   "
227769|NCT00834210|"     A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene     cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe     facial acne vulgaris   "
227833|NCT00835042|"     The objective of this study is to compare the relative bioavailability of Moexipril     HCl/hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA     Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets (Schwartz Pharma) in healthy,     adult non-smoking subjects under fasting conditions.   "
227770|NCT00834223|"     A prospective, multicenter, open-label, safety and preliminary efficacy study of the surgical     implantation of OPKO's glaucoma drainage device (AquashuntTM) in patients with refractory     chronic forms of open angle glaucoma (OAG). The primary objective of this study is to     evaluate the surgical implantation, safety and preliminary efficacy of the AquashuntTM after     implantation in patients with refractory chronic forms of OAG   "
227837|NCT00835094|"     This will be an open-label, randomized, parallel-group comparison of mometasone furoate dry     powder inhaler (MF-DPI) 400 mcg once daily administered in the morning vs. the evening for 12     weeks in subjects with asthma.   "
227775|NCT00834288|"     The purpose of this study was to compare the pharmacokinetic profiles at steady-state of the     test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product,     Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil Ultram®). For this purpose, the extent of     absorption of tramadol and formation of O-desmethyltramadol (measures of systemic exposure)     after multiple administration of 50 mg 6-hourly at 07:30, 13:30, 19:30 and 01:30 (reference     product) and 200 mg 24-hourly at 07:30 (test product), were compared.   "
227776|NCT00834301|"     The purpose of the study is to determine whether an ingestion of a new renal multivitamin     supplement can have a beneficial effect on bone and mineral adn inflammation issues related     to patients on dialysis.   "
227777|NCT00834314|"     The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques     (the so called abdominal dressing versus vacuum-pack-technique) are equally effective in     the treatment of open abdomen.      Secondary purpose is the comparison of feasibility and economic aspects.   "
227778|NCT00834327|"     This is a clinical trial to be conducted at multiple sites in the USA. Patients diagnosed     with moderate to severe Restless Legs Syndrome will be randomly allocated to one of 5     treatment arms in the study. The 5 arms include 4 arms with different doses of aplindore MR     tablets and 1 placebo arm. The treatment will be taken once a day. The study is blinded and     neither patients, nor the investigators, will know what treatment the patient is receiving.     Patients will be assigned a dose and will be maintained at that dose for several weeks (2     treatment arms include a short titration period). The entire study will take about 6 weeks.     The study will measure how effective aplindore is in decreasing symptoms of Restless Legs     Syndrome, and will also assess the safety and tolerability of aplindore.   "
227779|NCT00834340|"     The objective of this study is to compare the relative bioavailability of glimepiride 4 mg     tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA     Pharmaceuticals USA) with that of AMARYL® tablets (Aventis) in healthy, adult, non-smoking     subjects under fasting conditions.   "
227780|NCT00834353|"     N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) are two drug metabolizing     enzymes. Antituberculosis drug isoniazid is acetylated by NAT2 and forms ultimately a     nontoxic compound which is metabolized by CYP2E1 to a toxic metabolite. Slow acetylator     genotype of NAT2 and wild type genotype of CYP2E1 gene has been attributed to greater     toxicity of ATT drug. Therefore this study has been designed to analyze the genetic     polymorphism of NAT2 and CYP2E1 genes in tuberculosis patients who developed drug induced     hepatitis upon administration of antituberculosis drug.Polymorphism study of NAT2 and CYP2E1     gene may help in predicting the high risk group of ATT induced hepatitis.   "
227781|NCT00834366|"     To determine whether the test product, Labopharm Tramadol HCl Once-A-Day (OAD) 200 mg     film-coated tablets, and the reference product, Labopharm Tramadol HCl OAD 200 mg uncoated     tablets, are bioequivalent.   "
227782|NCT00834379|"     The objective of this study is to compare the relative bioavailability of pravastatin sodium     40 mg tablets with that of Pravachol® 40 mg tablets in healthy adult male subjects under     fasting conditions.   "
227783|NCT00834392|"     The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to     standard medical care (Control Group) in prostate cancer survivors receiving androgen     depletion therapy (ADT). The central hypothesis of the proposed research is that the walking     exercise program will have a positive impact on the bone health, health-related quality of     life, and physical function of men with prostate cancer receiving ADT.   "
227784|NCT00834405|"     The objective of this study is to compare the relative bioavailability of leflunomide 20 mg     tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA     Pharmaceuticals USA) with that of ARAVA 20 mg tablets (Aventis) in healthy, adult,     non-smoking subjects [females (who are unable to become pregnant) and vasectomized males]     under non-fasting conditions.   "
227785|NCT00834418|"     This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg     Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™     Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 20 mg tablet) in     healthy adult subjects under fasting conditions.   "
227786|NCT00834431|"     The objective of this study is to compare the relative bioavailability of famciclovir 500 mg     tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult     subjects under fasting conditions.   "
227787|NCT00834444|"     The objective of this study is to compare the relative bioavailability of famciclovir 500 mg     tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult     subjects under non-fasting conditions.   "
227834|NCT00835055|"     The purpose of this study is to determine whether markers on tumor tissue may be an indicator     for good response to neoadjuvant chemoradiotherapy in patients with rectal cancer.   "
227788|NCT00834457|"     Open-label study of a regimen of antiretrovirals for the treatment of AIDS-KS. This study     will be conducted at a single site, the Parirenyatwa Hospital KS Clinic.      Step 1 was conducted to determine the extent of clinical resolution of AIDS-KS disease in     response to treatment with antiretroviral therapy and to investigate whether clinical     resolution of KS is associated with suppression of KSHV replication.      Step 2 was developed to then evaluate the clinical, immunological, and virological effects of     a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI)     antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease     inhibitor in persons with AIDS-KS and good virologic suppression an all NRTI regimen.      Step 3 was included to evaluate the clinical, immunological, and virological effects of     intensification with a ritonavir-boosted protease inhibitor in persons with AIDS-KS who have     virological failure on an all NRTI regimen.   "
227789|NCT00834470|"     -  Ketamine seems an obvious choice in the setting of an emergency department        -  Ketamine leads to increased production of salivary and tracheal secretions        -  Antisialagogues(atropine)therefore have been recommended as a routine adjunct        -  We compare atropine with placebo as an adjunct to ketamine sedation in children          undergoing primary closure of lacerated wound   "
227994|NCT00836706|"     This study will compare the relative bioavailability (rate and extent of absorption) of 500     mg Clarithromycin Tablets with that of 500 mg BIAXIN® Tablets following a single oral dose (1     x 500 mg tablet) in healthy adult subjects under non-fasting conditions.   "
227790|NCT00834483|"     Barbed sutures offer several potential advantages in layered wound closure of hip and knee     replacement surgeries. It use is gaining increased acceptance across many of the other     surgical disciplines at this time. The purpose of this study is to evaluate the use of Quill     as part of our layered closure compared to using our traditional sutures. The study timeline     begins at the time of the surgical procedure and continues through the routine follow-up of     total joint replacements at 2, 6, and 12 weeks, and will conclude at the six month     post-operative office visit.      Primary Objectives:        -  To evaluate the safety and efficacy of wound closure in primary hip and knee          replacements using a bidirectional barbed suture (knotless) compared to a traditional          layered (vicryl) wound closure.      Secondary Objectives:        -  Establish the all around (intra-operative and post-operative) cost-savings potential in          using a knotless wound closure compared to that of a layered vicryl closure (our          standard suture protocol).        -  Assess the overall cosmesis of the wound/scar as well as perceived presence of          subcutaneous surgical knots, when using the knotless wound closure versus our          traditional layered suture closure.   "
227791|NCT00834496|"     Sirolimus can be safely switched as early as 90 days after liver transplantation with     excellent tolerability and amelioration of the calcineurin inhibitor toxicity that initiated     the switch.   "
227792|NCT00834509|"     The purpose of the study is to:        -  recruit subjects with untreated sleep apnea; assess overnight changes in their blood and          urine chemicals        -  review the overnight changes in blood and urine chemicals after they have been treated          for sleep apnea        -  assess the overnight changes in blood and urine chemicals in healthy individuals with no          sleep problems        -  compare the amount of fat in the belly using a Magnetic Resonance Imaging (MRI) scanner          on all subjects   "
227793|NCT00834522|"     The objective of this study is to evaluate the comparative bioavailability between     granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets     (Roche, USA), after a single-dose in health subjects under fed conditions.   "
227794|NCT00834535|"     This study will compare the relative bioavailability (rate and extent of absorption) of 300     mg Cefdinir Capsules manufactured and distributed by TEVA pharmaceuticals USA with that of     OMNICEF® Capsules by CEPH International Corporation for Abbott Laboratories following a     single oral dose (1 x 300mg capsule) in healthy adult subjects administered under non-fasting     conditions.   "
227795|NCT00834548|"     To compare to different approaches in whole-body magnetic resonance angiography of patients     suffering peripheral arterial disease.      Our hypothesis is that use of a new protocol improves the diagnostic quality of the WB-MRA     procedure.   "
227796|NCT00834561|"     This is a bioequivalence study to compare the rate and extent of absorption of lamotrigine     (test) and Lamictal® (reference)administered as a 1 x 200 mg tablet under fasting conditions.   "
227797|NCT00834574|"     The objective of this study is to compare the relative bioavailability of cefdinir for oral     suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of     OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects     under fasting conditions.   "
227798|NCT00834587|"     This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg     Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical     Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg     METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500     mg tablet) in healthy adult subjects administered under non-fasting conditions.   "
227799|NCT00834600|"     The purpose of this research study is to determine whether a simple blood test measuring a     hormone called renin can better determine which first drug would be most effective in     controlling blood pressure, in comparison with the more traditional approach recommended by     JNC7 (Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High     Blood Pressure).   "
227800|NCT00834613|"     The objective of this study is to compare the rate and extent of absorption of metformin from     a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg     Tablets under fed conditions.   "
227801|NCT00834626|"     Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated     Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy     (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic     control in Type 2 Diabetes patients.   "
227802|NCT00834639|"     This study will compare the relative bioavailability of 500 mg Divalproex Sodium     Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1     x 500 mg tablets)in healthy subjects under fasting conditions.   "
227803|NCT00834652|"     This study will determine whether the drug metformin improves the effects of traditional     antidepressant medications in people who are overweight.   "
227868|NCT00828698|"     The purpose of this observational study is to find characteristics and risk stratification     methods for identification of subjects who have increased risk of death, especially sudden     cardiac death, after acute myocardial infarction.   "
227804|NCT00834665|"     The purpose of this study is:        1. To evaluate the safety of activated T cell infusions and immunization with hTERT          multi-peptide vaccine in the post-transplant setting and whether the combination can          delay hematopoietic recovery or induce other autoimmune events.        2. To determine whether the strategy of infusing vaccine-primed T-cells early after          transplant in conjunction with post-transplant boosters leads to the induction of          cellular immune responses to hTERT.   "
227805|NCT00834678|"     RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. Giving bendamustine together with erlotinib     may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving     bendamustine together with erlotinib in treating patients with stage IIIB, stage IIIC, or     stage IV breast cancer.   "
228591|NCT00848029|"     The present study will evaluate the immunogenicity, safety and immunogenicity of two doses of     monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a     surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult Subjects.   "
227806|NCT00834691|"     Anemia is frequent in patients with heart failure. Few studies have clearly addressed the     causes of anemia in patients with HF. The purpose of this study is to evaluate differences in     blood concentrations of various substances related to inflammation, oxidative stress, renal     function and other processes between individuals with 1) heart failure and anemia, 2) heart     failure without anemia and 3) patients with kidney disease without systolic heart failure.     This study will help to better understand the reasons why some people with heart failure have     anemia.   "
227807|NCT00834704|"     Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.   "
227808|NCT00834717|"     The objective of this study is to evaluate the comparative bioavailability between     granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets     (Roche, USA), after a single-dose in health subjects under fasting conditions.   "
227809|NCT00834730|"     -  Ketamine provides effective and relatively safe sedation analgesia for primary closure          of lacerated pediatric patients        -  However, deep sedation and adverse effects suggest the opportunity to develop          alternative strategies        -  We compared the efficacy and adverse effects of ketamine to those of N2O gas for          analgesia and anxiolysis during primary repair of lacerated pediatric patients   "
227810|NCT00834743|"     The objective of this study is to compare the rate and extent of absorption of metformin from     a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg     Tablets under fasting conditions.   "
227811|NCT00834756|"     The objective of this randomized, single-dose, two-way crossover evaluation is to compare the     relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an     equivalent oral dose of the commercially available azithromycin (Zithromax®, Pfizer, Inc.) in     a test population of 36 adult subjects under fasting conditions.   "
227812|NCT00834769|"     Investigation of chronic pain frequency after thoracotomy for lung cancer. Risk factors for     development of chronic pain are investigated. Questionnaire survey.   "
227813|NCT00834782|"     To compare intraocular pressure (IOP) measured by the Reichert Ocular Response Analyzer     (ORA), Pascal dynamic contour tonometer (DCT) and Goldmann applanation tonometer (GAT) in     eyes after Penetrating Keratoplasty (KPL)   "
227814|NCT00834795|"     The objective of this randomized, single-dose, two-way crossover evaluation is to compare the     relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and     equivalent oral dose of the commercially available carvedilol (COREG®, SmithKline Beecham     Pharmaceuticals) in a test population of 36 adult individuals under fasting conditions.   "
227815|NCT00834808|"     The purposes of this study were:        -  To evaluate the plasma pharmacokinetic profile of tramadol and its principal metabolite,          the O-desmethyltramadol, after a single oral administration of 100, 200 and 300 mg of          tramadol as the Labopharm extended-release formulation prepared with Contramid.        -  To assess the dose linearity of tramadol and its principal metabolite, the          O-desmethyltramadol, between 100 mg and 300 mg following a single dose administration of          the Labopharm extended-release formulation prepared with Contramid under fasting          conditions in young healthy volunteers.   "
227816|NCT00834821|"     This study will test the effectiveness of a new behavioral treatment, called the Child Life     and Attention Skills Program, for children with attention deficit hyperactivity disorder,     inattentive type.   "
227817|NCT00834834|"     This study will compare the effectiveness of two treatments, dialectical behavior therapy     versus fluoxetine with clinical management, for reducing the risk of self-injury and suicidal     behavior in people with borderline personality disorder.   "
227818|NCT00834847|"     The objective of this study is to compare the relative bioavailability of pravastatin 40 mg     tablets with that of Pravachol 40 mg tablets in healthy adult male subjects under non-fasting     conditions. A second objective is to compare the difference in plasma levels after dosing the     test formulation with and without food.   "
227819|NCT00834860|"     Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the     treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The     efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its     impact on the outcome in chronic hepatitis C patients concomitant with hepatocellular     carcinoma deserve to be elucidated.      The purposes of this study are:        1. To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin          combination therapy in chronic hepatitis C patients concomitant with hepatocellular          carcinoma.        2. To investigate the role of baseline and on-treatment factors on the response to          pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C          patients concomitant with hepatocellular carcinoma.   "
227820|NCT00834873|"     The objective of this randomized, single-dose, two-way crossover evaluation is to compare the     relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and     equivalent oral dose of the commercially available carvedilol (COREG®, SmithKline Beecham     Pharmaceuticals) in a test population of 24 adult individuals under fed conditions.   "
227869|NCT00828711|"     The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg     Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical     ripening and induction of labor.   "
227821|NCT00834886|"     In this study the investigators will examine the effects of melatonin and light therapy on     delayed sleep phase syndrome in adolescents 16 up to 20 years old. 60 subjects will be     randomized into four different groups; melatonin + light therapy (N=15), melatonin + placebo     light (N=15), placebo + light therapy (N=15) and placebo + placebo light. This is a     double-blinded treatment and the participants will receive this treatment for 2 weeks. Then     they will be re-randomized into two groups; full treatment with light therapy + melatonin     (N=30) and no treatment (N=30) for 3 months unblinded. The investigators will test the     subjects pre-treatment, post 2 week treatment and after 3 months.   "
227854|NCT00828516|"     RATIONALE: Acupuncture and moxibustion may improve well-being and quality of life in patients     with lymphedema caused by breast cancer or head, neck, and throat cancer.      PURPOSE: This clinical trial is studying how well acupuncture given together with moxibustion     works in improving well-being and quality of life in patients with breast cancer or head,     neck, and throat cancer who are undergoing standard treatment for lymphedema.   "
227822|NCT00834899|"     This study will evaluate the safety of eptifibatide in sickle cell patients and how well it     works during the course of painful crises. The overall hypothesis that we seek to test is     that increased platelet activation and the resultant inflammatory responses are important     contributors to the problems of sickle cell disease. Sickle cell disease has been referred to     both as a condition associated with increased risk of blood clots and increased inflammation.     A painful crisis represents the most common cli nical problem in sickle cell disease, but the     treatment of these crises remains inadequate.   "
227823|NCT00834912|"     The objective of this study is to compare the rate and extent of absorption of two Tramadol     Contramid® OAD 300 mg controlled-release tablets from two different manufacturing sites,     administered as 1 x 300 mg controlled-release tablet under fasting conditions. The effect of     food on the to-be-marketed formulation was also assessed.   "
227824|NCT00834925|"     This study is to show the efficacy and safety of low dose diltiazem for the treatment of     atrial fibrillation with rapid ventricular response in emergency room. We will compare the     standard dose of diltiazem(0.25mg/kg) with low dose diltiazem(0.1mg/kg)in atrial fibrillation     with rapid ventricular response in ED.   "
227825|NCT00834938|"     Bariatric surgery can lead to improvement or even resolution of type 2 diabetes in about 80%     of patients submitted to Roux-en-Y gastric bypass (RYGP). Otherwise, many patients     experienced no resolution of their diabetes despite massive surgical-induced weight loss.     There appears to be a variable response to surgery depending on surgical and patient factors.     To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed     to make a description of effects of surgical procedures on incretin, insulin production and     sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.   "
227826|NCT00834951|"     The purpose of this study is to determine whether the application of low dose total body     irradiation following chemo-immuntherapy in elderly patients with aggressive with     non-Hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy   "
227827|NCT00834964|"     The objective of this study is to compare the rate and extent of absorption of venlafaxine 25     mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fasting     conditions.   "
227828|NCT00834977|"     The objective of this study is to compare the rate and extent of absorption of     amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered     as 1 x 10 mg capsule under fasting conditions.   "
227829|NCT00834990|"     This study will compare the relative bioavailability of 500 mg Divalproex Sodium     Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1     x 500 mg tablets) in healthy subjects under non-fasting conditions.   "
227830|NCT00835003|"     The caesarean section rate is rising globally. About 10% of the newborns are submitted to a     neonatal department after planned caesarean section, primarily with respiratory disorders.     More children are submitted if caesarean is performed earlier in pregnancy.      Study hypothesis: More newborns are admitted after planned caesarean at 38 weeks and 3 days     of gestation than after 39 weeks and 3 days of gestation.      Aim of study: To compare elective caesarean section performed at 38 weeks and 3 days of     gestation with 39 weeks and 3 days of gestation. According to this timing to determine the     proportion of newborns admitted within 48 hours after birth.   "
227831|NCT00835016|"     Aim:      To assess the feasibility of provision of an early psychosocial stimulation programme for the     children of depressed mothers and to determine its effect on, mothers depression , mothers'     knowledge and practices of childrearing and on children's development.      Hypothesis:      Primary hypothesis:      Mothers attending the psychosocial stimulation program will have significant improvement in     the level of depression as compared to the mothers who are on the waiting list.      Secondary hypothesis:      Children of mothers having the intervention will have significantly better growth than the     children of mothers who do not have the intervention.      Design:      Randomised controlled trial.      Setting:      An urban slum in a township in Karachi.      Participants:      A total of 130 randomly selected depressed mothers in the intervention group and a total of     130 mothers in the waiting list control group.      Interventions:      Weekly LTP groups for the first eight sessions and two fortnightly sessions. Parenting issues     will be discussed with the mothers and play activities will be demonstrated with the children     using LTP and homemade materials.      Main outcome measures:      Mothers scores on EPDS & HAM D , Parenting stress as measured by PSI-SF and mothers'     knowledge and practices of child rearing measured by questionnaires. Children's height,     weight, head and arm circumference.   "
227832|NCT00835029|"     Background: Oral candidiasis is most frequently found among the elderly .It is accompanied     with oral pain, irritation, burning sensation. In addition, the altered taste sensation may     cause nutrition compromise, which may affect ones diet. Management of superficial oral     Candida is usually achieved by treatment with clotrimazole, a fungi static drug which is     given five times per day with instruction to slowly suck on it with out the dentures.      Working hypothesis and aims: Management of oral candidiasis is feasible. The major     disadvantage of the mode of action now days is the substantively of the drug in the oral     cavity and patient compliance. A sustained release varnish which is easily applied on the     dentures, which also release the anti fungal drug for at least a day, may overcome some of     the pit falls of the treatment applied today.      Based on our past experience, in developing local sustained release varnishes for dental use,     we anticipate that we can also formulate a special anti fungal sustained release varnish     which will fit the special and unique needs of the elderly population.      Methods: Sustained release varnish will be developed in our laboratory. The kinetics of     release (using HPLC) and antifungal activity (Bioassays) will be examined in vitro. The     formulation showing the optimal results will be tested on human subjects with oral     candidiasis. The efficacy of the varnish will be examined clinically (reduction in symptoms),     microbiology (reduction of oral fungal), pharmaceutically (release kinetics in vivo).      Expected results: The clinical out come of one time varnish application will be improved     compared to the five times application of lozenges (used today). The severity of the disease     should decrease and the healing period should be shorten drastically.      Importance: This is a novel pharmaceutical development of a local application of a dental     varnish designed specially to the elderly population   "
227870|NCT00828724|"     The purpose of this study is to evaluate the PK properties in fed and fasted men and women.   "
227835|NCT00835068|"     The primary objective of this observational study is to collect safety data on reformulated     BeneFIX as prescribed in routine clinical practice conditions in France. The secondary     objectives are to collect data on the clinical course of individuals treated with     reformulated BeneFIX and on the ease of reformulated BeneFIX.   "
227836|NCT00835081|"     The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg     capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules     (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal     healthy non-smoking male and female subjects under fed conditions.   "
227838|NCT00835107|"     This study uses polysomnographs(PSG) to investigate sleep patterns in patients with bipolar     depression. This is a double-blind, placebo-controlled, study of ziprasidone that is added to     patients current medications. The objective is to relate changes in slow wave and rapid eye     movement sleep to changes in mood and overall illness severity. Participants will be randomly     assigned to add either placebo or ziprasidone to their current treatment regimen.     Participants make 3 to 4 study visits, over a 1 month period, at which they will be asked     about their history, mood and sleep quality. Participants will also have three in-home     overnight polysomnographs.   "
227839|NCT00835120|"     The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of     bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who     experience a partial or full response will have the option of continuing in an acute     continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the     safety and tolerability of pioglitazone during the acute continuation period.   "
227840|NCT00835133|"     RATIONALE: Collecting and storing samples of blood and tissue from family members of patients     with cancer to test in the laboratory may help the study of cancer in the future.      PURPOSE: This clinical trial is collecting blood and tissue samples from family members of     patients with pancreatic disease, pancreatic cancer, and melanoma.   "
227841|NCT00835146|"     The objective of this study is to compare the relative bioavailability of ribavirin 200 mg     tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA     Pharmaceuticals USA) with that of COPEGUS™ 200 mg tablets (Roche) in healthy, adult,     non-smoking, females (who are unable to become pregnant) under fasting conditions.   "
227842|NCT00828360|"     While cardiac resynchronization therapy (CRT) has a well demonstrated therapeutic effect in     selected patients with advanced heart failure (HF) on optimized drug therapy, non-responder     rate remains high. The low-dose dobutamine stress-echo (DSE) test to predict positive     response to CRT (LODO-CRT) trial is designed to improve patient selection for CRT.   "
227843|NCT00828373|"     Lidocaine is a local anesthetic which is widely used in daily anesthesia and surgical     practice. It has been shown that intravenous lidocaine given during an operation has     analgesic properties. Finally intravenous lidocaine is inexpensive and easy to administer and     safe if non-toxic doses are respected. It is likely that the use of lidocaine infusions     during anesthesia might increase in the coming years. Neuromuscular blockers (curare like     substances) are used in anesthesia to facilitate tracheal intubation and to achieve muscle     relaxation and immobility during surgery. Rocuronium is one of the most widely used     neuromuscular blocking agents. Local anesthetics, such as lidocaine, are known to potentiate     the effect of neuromuscular blocking agents. In the study the investigators want to evaluate     the effect of intravenous lidocaine during the operation on the time course of the     rocuronium-induced neuromuscular block. A secondary aim is to evaluate intubation conditions     (lidocaine has been shown also to improve intubation conditions) and safety.   "
227844|NCT00828386|"     This is a randomized, multicenter, phase III trial comparing induction chemotherapy with     Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to     concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or     with lymph node involvement (≥ N1. The main end point is the event free survival.   "
227845|NCT00828399|"     Ionizing radiation has cytotoxic effects, and is commonly used as treatment for neoplasm. A     common adverse effect of radiation is acute diarrhoea. Glutamine is an aminoacid with     antioxidant effects that can protect tissues of damage dued to radiation. The investigators     designed a randomized, double-blind trial phase III to study if glutamine prevents acute     radiation enteritis.   "
227846|NCT00828412|"     This study compares the effectiveness of two topical creams for atopic dermatitis in     pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice     daily for 6 weeks or until clear.   "
227847|NCT00828425|"     Aim of this NIS is to retrospectively document the management of diabetic patients with     retinopathy in a naturalistic setting in Switzerland. Following elements are going to be     analyzed:        -  which medication are used to keep blood pressure under control?        -  which medication are used for metabolic control?        -  the average control level of metabolism and blood pressure is compliant with the          international guidelines?        -  laser photocoagulation plays a role in the control of metabolism and blood pressure?        -  there are differences in the control of metabolism and blood pressure between patients          with DM I or DM II?        -  there is an influence of renal failure on the choose of medication?   "
227848|NCT00828438|"     The purpose of this study is to evaluate the PK properties of lorcaserin in subjects with end     stage renal disease (ESRD) who require dialysis and will be studied under dialysis and     non-dialysis conditions.   "
227849|NCT00828451|"     This proposal will test the hypothesis that synthesis and catabolism of epidermal growth     factor, the genotype of the EGF gene, and the microbiome interact to influence EGF expression     in infants at risk for necrotizing enterocolitis (NEC).   "
227850|NCT00828464|"     The purpose of the study is to assess the safety, efficacy and tolerability of Clobetasol     propionate foam in subjects with chronic dermatitis.   "
227851|NCT00828477|"     The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac     following SLT.   "
227852|NCT00828490|"     The purpose of the Utah ePRM (electronic Pharmacotherapy Risk Management) project is to     improve quality and safety of medication use while simultaneously controlling costs and     detecting fraud and abuse.   "
227853|NCT00828503|"     A prospective, randomized safety and efficacy study of Certican® as add-on therapy against     CMV disease in renal transplant recipients      OBJECTIVES:      Primary Objective:      To demonstrate efficacy of Certican® as add-on therapy against CMV disease in comparison to     either valcyte® (valganciclovir) or cymevene® (ganciclovir) alone, evaluated by quantitative     measurement of CMV-DNA with PCR from the blood (qCMV-PCR)      Secondary Objectives:      To assess safety and tolerability of Certican® in patients with CMV- disease To study the     effects of Certican® treatment on quality of life   "
227855|NCT00828529|"     The purpose of this Phase I, open-label, randomized crossover trial is to investigate the     pharmacokinetic interaction between steady-state lopinavir/ritonavir and single-dose TMC207     in healthy volunteers.   "
227857|NCT00828555|"     PURPOSE To develop, implement, and evaluate the effectiveness of a program designed to assist     community Ob/Gyns in vaccinating adolescent and adult women against vaccine-preventable     diseases.      SPECIFIC AIMS        1. Determine the feasibility of implementing a successful vaccination program for          adolescent and adult women in Ob/Gyn offices by direct assessment of medical personnel &          office staff on their:             -  Attitudes towards vaccination of women against preventable diseases             -  Perceived barriers to implementing a program to vaccinate women in their offices             -  Ideas on how to overcome barriers to successful program implementation             -  Current vaccination practices and office-specific administrative processes        2. Design & implement a program for Ob/Gyns to vaccinate women against human          papillomavirus, influenza, & pertussis        3. Determine the effectiveness of the vaccination program based on             -  Pre- and post-program vaccination rates             -  Program satisfaction amongst Ob/Gyn providers and office staff             -  Willingness to continue and possibly extend the program to additional vaccines        4. Quantify the level of support and resources needed to develop and implement the          vaccination program   "
227858|NCT00828568|"     The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%,     manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M,     and to show superiority over vehicle in the treatment of AK.      The secondary objective is to compare the adverse event (AE) profiles of the two creams.   "
227859|NCT00828581|"     The purpose of this study is to evaluate the PK properties of lorcaserin in obese or     overweight elderly subjects.   "
227860|NCT00828594|"     Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in     patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose     (MTD)      Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time     to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to     sorafenib alone   "
227861|NCT00828607|"     This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose     noninvasively focal liver masses. This is a multi-center prospective cohort study of 250     subjects, which will be performed at four institutions in Canada. Subjects with a focal liver     mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional     baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed     on standard ultrasound scanners with contrast specific imaging capability. The contrast agent     used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a     dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the     standard of care in the institution. Anonymized image files from all imaging will be shown     independently to two readers, blinded to all clinical and demographic data, who will predict     malignancy and diagnosis.   "
227862|NCT00828620|"     Molecular imaging with positron emission tomography (PET) using [18F] fluorodeoxyglucose     (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs     by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be     highly sensitive in detecting early response in other tumours. In this study, the     investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6)     in outcome prediction.   "
227863|NCT00828633|"     RATIONALE: Gathering information about prostate cancer, treatment, and quality of life from     gay men with prostate cancer may help doctors plan the best treatment.      PURPOSE: This clinical trial is collecting information about health-related quality of life     from gay men with localized prostate cancer.   "
227864|NCT00828646|"     The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics,     and pharmacodynamics following 14-day multiple oral doses BMS-708163 in healthy young male     Japanese and healthy elderly male and female Japanese subjects   "
227865|NCT00828659|"     The purpose of this study is to evaluate the abuse potential of lorcaserin in healthy     recreational polydrug users.   "
227866|NCT00828672|"     Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly     multinational). Academic, investigator initiated.      To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM)     and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment     of locally advanced rectal cancer, followed by TME (total mesorectal excision).   "
227867|NCT00828685|"     The purpose of this study is to compare early return to function in patients treated with     closed reduction percutaneous pinning and open reduction internal fixation in displaced     fractures of the distal radius.      Hypothesis: Wrist range of motion, grip strength and outcome at 2-3 months after injury are     better in patients treated with open reduction, internal fixation (ORIF) than in patients     treated with closed reduction percutaneous pinning techniques (CRPP). In addition patients     treated with ORIF return to work at faster rates.   "
227940|NCT00835978|"     Axitinib dose titration (giving a higher dose of the drug above its standard starting dose)     among certain patients may improve the response to treatment.   "
227871|NCT00828737|"     Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging     (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.      The administration of contrast agents that contain gadolinium such as Gadovist might increase     a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in     patients with renal impairment. This study is to assess the potential risk to develop NSF in     patients with renal impairment after the administration of Gadovist. Patients who are     enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the     referring doctor. After the MRI scan the patient will be included in a two year follow-up     period to assess if signs or symptoms suggestive of NSF have appeared.   "
227872|NCT00828750|"     An open-label, dose-adjustment extension study to evaluate the safety and efficacy of     eltrombopag for treatment of subjects with ITP who have previously been enrolled in the     eltrombopag trial TRA108109 (NCT00540423).   "
227873|NCT00828763|"     Mass balance study to determine the recovery of a single radiolabelled dose of GSK1349572     from urine and feces   "
227999|NCT00836771|"     Evaluation the nutritional suitability of a based milk infant formula supplemented with     friendly bacteria (probiotic microorganisms) and or nutritional fibers (prebiotic) to     healthy, full term infants compare with an otherwise identical widely used commercially     available milk based infant formula and/or breast feed   "
227874|NCT00828776|"     The primary objective of the study was to assess the safety in use of the drug Heparin     Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche     Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the     product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the     parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of     hemodialysis.   "
227875|NCT00828789|"     The purpose of this study is to determine the effect of EFV (Efavirenz) and TDF (Tenofovir     disoproxil fumarate) on the pharmacokinetics of TVR (Telaprevir) and to determine the effect     of TVR on the pharmacokinetics of EFV and TDF. Pharmacokinetics means how the drug is     absorbed into the bloodstream, distributed in the body and eliminated from the body.     Furthermore, the short-term safety and tolerability of giving TVR, EFV and TDF together will     be evaluated.   "
227876|NCT00828802|"     The purpose of this study is to find out what dose of lenalidomide is safe to use in     combination with decitabine when given in people with myelodysplastic syndrome.   "
227877|NCT00828815|"     TMC125 is from the class of drugs called non-nucleoside reverse transcriptase inhibitors     (NNRTIs). NNRTIs work by blocking reverse transcriptase, a protein that HIV needs to make     more copies of itself. TMC125 is used in the treatment of adults with HIV-1 infection. The     purpose of this trial is to see if there is any potential interaction (change in the     effectiveness of the drug) when taking multiple-dose TMC125 and buprenorphine/naloxone     together. The trial will also assess the short-term safety and tolerability (how well your     body handles the drug) when TMC125 and buprenorphine/naloxone are taken together.   "
227878|NCT00828828|"     The purpose of this study is to determine the efficacy of influenza vaccine (antibody     response) in patients with sarcoidosis.   "
227879|NCT00828841|"     This study is testing the investigational drug, cetuximab, in combination with different     chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug     combinations looks most promising and should be tested further. The study will also look at     what side effects may occur.   "
227880|NCT00828854|"     The addition of SNDX-275 to an AI will result in a maximal abrogation of estrogen receptor-α     mediated activity and inhibit mechanisms of resistance to the aromatase inhibitor.      It is hypothesized that SNDX-275 with continued AI will increase the estimated AI clinical     benefit rate (CBR) from 5% to 25% with an acceptable safety profile.   "
227881|NCT00828867|"     This is a first time in human (FTIH) study of single escalating doses of investigational     study drug to investigate safety, tolerability, and pharmacokinetics in healthy subjects   "
227882|NCT00828880|"     The investigators hypothesize that a 6-week treatment of non-invasive spinal decompression     reduces discogenic low back pain (LBP), increases lumbar disk height, and that an increase in     lumbar disc height is associated with decreased LBP.   "
227883|NCT00828893|"     The purpose of this study is to assess the contribution of navigation systems recently     developed to guide the punction needle.   "
227884|NCT00828906|"     To evaluate the effectiveness of DuoTrav Eye Drops in gaining or maintaining control of     target Intraocular Pressures (tIOP) in patients diagnosed with, and being treated for,     open-angle glaucoma (OAG) or ocular hypertension (OH).   "
227885|NCT00828919|"     To allow continuation of treatment of patients experiencing benefit from AG 013736   "
227886|NCT00828932|"     The purpose of this study is to evaluate and establish whether lorcaserin dose adjustment is     required in patients with mild or moderate hepatic impairment.   "
227887|NCT00828945|"     It is a prospective observational study.      Patients will be high risk patients (for developing cardiovascular events) that are treated     with a statin. Patients will be enrolled at a normal clinic visit and provided with a small     box containing info about the disease, a LDL self-test and two questionnaires. They will test     themselves for LDL at home between normal clinic visits (normally 12 months interval) and     note their value. In the end of the study all patients will fill out a questionnaire with     questions if the tests and info have raised their awareness of the disease as well if their     motivation to be compliant has increased.      We want to look at the possibility to put more responsibility for treatment and for reaching     treatment goals on the patients since there's a big problem with compliance in this group of     patients.   "
227888|NCT00828958|"     The purpose of this study is to examine the discontinuation rate of schizophrenia patients     receiving multiple sequential 2 mL injections of long acting injectable risperidone (an     atypical antipsychotic medication) when administered into the deltoid muscle once every 2     weeks.   "
227889|NCT00828971|"     The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin is     as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the treatment     of complicated skin and skin structure infection.   "
227890|NCT00828984|"     This randomized phase II trial studies how well macrogol 3350-based oral osmotic laxative     (polyethylene glycol 3350) works in preventing cancer in patients at risk of colorectal     cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of     macrogol 3350-based oral osmotic laxative may stop cancer from growing in patients who are at     risk of colorectal cancer.   "
227891|NCT00828997|"     Previous studies have analyzed serological responses following pneumococcal vaccination using     23-valent vaccination (Pneumovax) in Rheumatoid Arthritis (RA) patients that were on     different therapeutic modalities including TNF-blockers and methotrexate. The results have     shown that serological response was significantly reduced in RA patients receiving     methotrexate compared to those receiving TNF-blockers.      In contrast when using polypeptide immunisation (influenza vaccine) we found that anti-TNF     significantly impaired the serological response compared to the methotrexate treated RA     patients. The aim of this study is to analyze serological responses after Prevenar     vaccination in patients with chronic arthritis and to study the impact of different treatment     modalities on serological responses.      It will be of interest to see if the result is different compared to the one seen after     immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine.   "
228000|NCT00836784|"     This study aimed to validate or invalidate non-inferiority in the plaque removal efficacy of     old versus new toothbrushes in the hands of 7-9 year old children. This study was conducted     in 93 Iranian students aged between 7-9 year old.   "
227892|NCT00829010|"     The purposes of this study:        -  To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine          GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed          uninfected infants following a 3-dose primary vaccination at 6, 10 and 14 weeks of age          and following booster vaccination at 9-10 months of age.        -  To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine          GSK1024850A in HIV unexposed uninfected infants receiving either a 3-dose primary          vaccination according to the EPI vaccination schedule at 6, 10 and 14 weeks of age with          or without booster vaccination at 9-10 months of age or a 2-dose primary vaccination at          6 and 14 weeks of age followed by booster vaccination at 9-10 months of age.        -  This study also aims to assess the impact of the pneumococcal vaccine GSK1024850A on          nasopharyngeal carriage of S. pneumoniae and H. influenzae up to 24 months of age in all          study participants.   "
227893|NCT00829023|"     The purpose of the present study was to examine the native bacteria around the shoulder and     determine the efficacy of three different surgical skin-preparation solutions on the     eradication of bacteria from the shoulder.   "
227894|NCT00829036|"     The purpose of the project is to find out what kinds of information are most useful to     visually impaired people when they are moving around indoors and what kinds of controls will     make it easy for visually impaired people to control a device to help orient them to an     unfamiliar indoor space.   "
227895|NCT00829049|"     Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel     0.3% in treating moderate to severe facial acne vulgaris   "
227896|NCT00829062|"     The purpose of the study is to present evidence based literature and clinical data to the     medical directors at Missouri Medicaid to help modify the existing policy regarding insulin     pump therapy in pediatric patients with diabetes.   "
227897|NCT00829075|"     Exploratory study assessing the effect of three gonadotrophin protocols on Controlled Ovarian     Stimulation (COS) parameters and IVF outcome in oocyte donors undergoing GnRH analogue (long     protocol). 1,028 donors were randomized in three groups: Group I (n= 346) only r-FSH, Group     II (n= 333) only HP-hMG and Group III (n= 349) r-FSH plus HP-hMG. IVF outcome of 1,059 oocyte     recipients was compared.   "
227898|NCT00829088|"     The aim of this study is to get information about absorption, distribution, metabolism and     excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.   "
227899|NCT00829101|"     The purpose of the study is to assess if there are any differences in the articulatory and     phonological competence in pre-school children with unilateral cleft lip and palate (UCLP)     who are treated with different surgical methods of palatal repair.   "
227900|NCT00829114|"     Non-randomized, comparative study (1:1 allocation) to study interactions between     nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.   "
227901|NCT00829127|"     The aims of the study are to evaluate the safety, tolerability and pharmacokinetics of     AZD8075 in healthy male subjects at increasing doses when given for 14 days   "
227902|NCT00835159|"     The purpose of this study is to determine whether preoperative administration of Rivastigmine     prevents the incidence of postoperative delirium in patients undergoing major surgery as well     as postoperative cognitive dysfunction.   "
227903|NCT00835172|"     The objective of this study is to compare the relative bioavailability of glimepiride 4 mg     tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA     Pharmaceuticals USA) with that of AMARYL® tablets (Aventis) in healthy, adult, non-smoking     subjects under non-fasting conditions.   "
227904|NCT00835185|"     The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is     effective in treating colorectal cancer (CRC).   "
227905|NCT00835198|"     A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin     gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe     facial acne vulgaris   "
227906|NCT00835211|"     The objective of this study was to compare the single-dose relative bioavailability of TEVA     and Aventis Pharmaceuticals (DDAVP®) 0.2 mg desmopressin acetate tablets following a 0.8 mg     dose under fasting conditions.   "
227907|NCT00835224|"     After a spinal cord injury the brain is no longer completely in control of the body below the     level of injury. This affects many organs and systems in the body, we are interested in     understanding how a spinal cord injury affects blood pressure and blood flow to the brain. We     are going to study blood pressure while the person is seated in a wheelchair before and after     we give the subject medications which should increase blood pressure in a laboratory setting     and over the course of a normal day in persons with spinal cord injury.   "
227908|NCT00835237|"     This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK     Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.   "
227909|NCT00835250|"     The purpose of the study is to determine the feasibility of cholecystectomy made by a     transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic     surgery).   "
227910|NCT00835263|"     The objective of this study is to compare the rate and extent of absorption of lamotrigine     200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under     fed conditions.   "
227941|NCT00835991|"     The objective of this study is to compare the rate and extent of absorption of     Glyburide/Metformin 5 mg/500 mg film-coated tablets (test) versus Glucovance® (reference)     administered as 1 x 5 mg/500 mg film-coated tablet under fed conditions.   "
227911|NCT00835276|"     This study will compare the relative bioavailability (rate and extent of absorption) of 180     mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd.     with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral     dose (1 x 180 mg tablet) in healthy adult volunteers under fasting conditions.   "
227995|NCT00836719|"     This study is an open label 6 month study. All subjects will be treated with Polyphenon E     (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be     safety. Secondary outcomes are the change in NAA levels over 6 months as measured by     MR-spectroscopy. NAA levels are a marker of neuronal function. We think that Polyphenon E     will protect neurons and thus increase NAA levels.   "
227996|NCT00836732|"     The aim is to study small genetic alterations induced by cell culture in human mesenchymal     stem cells in GMP condition.   "
227912|NCT00835289|"     Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death     in the United States. Unlike the other leading causes of death, no medical therapies     currently available improve the course of disease or affect survival in COPD. Recent     investigations suggest that endothelial dysfunction and chronic inflammation is fundamental     to COPD. Fish oil intake improves endothelial dysfunction and lowers levels of inflammatory     intermediaries which may be important in the development of COPD.      The Chronic Obstructive Pulmonary Disease Fish Oil (COD-Fish) Pilot Trial will enroll 40-45     participants with COPD. These participants will be randomized to receive omega-3     polyunsaturated fatty acid supplementation (PUFA) or placebo (containing corn oil). All     participants will perform a number of noninvasive tests (including flow-mediated dilation     (FMD) and pulmonary function testing) at study entry as well as every two months for a total     of six months. Thirty participants who agree to it will undergo a separate procedure to     collect cells from inside a forearm vein for analysis to be compared to 30 controls. The main     purpose of this trial is to examine the effect of PUFA on endothelial function as measured by     change in FMD in patients with COPD. We hypothesize that in subjects with COPD, treatment     with PUFA will increase FMD.   "
227913|NCT00835302|"     The investigators seek to develop a clinical prediction rule (CPR) to identify patients with     a primary complaint of shoulder pain who are likely to benefit from manual therapy to the     neck and upper back regions. Manual therapy will include mobilizations (therapist moves the     joints in an oscillating fashion) and manipulations (therapist performs a high velocity low     amplitude movement) The investigators hypothesize that a cluster of signs and symptoms from     the subject history and physical examination will exist that maximize the accuracy of     identifying patients with a primary complaint of shoulder pain likely to benefit from this     manual therapy treatment based on a reference standard of patient-reported improvement.      The investigators also seek to investigate the psychometric properties (how good a test is),     including test retest reliability of a modified version of the Fear Avoidance Beliefs     Questionnaire (FABQ) and the shortened Tampa Scale for Kinesiophobia (TSK-11) in patients     with shoulder pain. The investigators will also look at the convergent validity (determine if     measures that should be related are in reality related) and discriminant validity (show that     measures that should not be related are in reality not related) of the modified FABQ and the     TSK-11 in patients with shoulder pain.   "
227914|NCT00835315|"     Interdigital psoriasis (psoriasis alba) is atypical and rare form of psoriasis that is often     missed as it is commonly mistaken for either dermatoses or fungal infection.In this study we     observed and analyzed the prevalence of psoriasis interdigital of palms and soles and brought     medical awareness to dermatologists and family doctors this rare form of psoriasis. Thus, you     can help to avoid mistaken diagnosis and the start of correct treatment as soon as possible.   "
227915|NCT00835328|"     The purpose of this study is to examine the effect of exendin-(9-39)on glucose requirements     to maintain euglycemia in infants with congenital hyperinsulinism unresponsive to medical     therapy   "
227916|NCT00835341|"     Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese     adults. Biomarker is not available for detection of malignant potential of OED till now. p16     is an important tumor suppressor gene, which is inactivated frequently by methylation of CpG     island in early stage of carcinogenesis. The present cohort study is to investigate whether     p16 methylation is correlated with malignant transformation of OED.   "
227917|NCT00835354|"     The objective of this study is to compare the relative bioavailability of cefprozil for oral     suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension     250 mg/5 mL (Bristol-Myers Squibb) in healthy, non-smoking adults under non-fasting     conditions.   "
227918|NCT00835367|"     The objective of this study is to compare the rate and extent of absorption if     amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference),administered as     1 x 10 mg- 20 mg capsule under fed conditions.   "
227919|NCT00835380|"     This study will demonstrate the immunogenicity and evaluate the safety/tolerability of the     vaccine in Chinese children between 12 and 23 months of age.   "
227920|NCT00835393|"     The Objective of this study is to compare the relative bioavailability of pantoprazole sodium     40 mg delayed-released tablets (manufactured by TEVA Pharmaceutical Industries,Ltd. and     distributed by TEVA Pharmaceuticals USA)with that of PROTONIX® 40mg delayed-released tablets     (Wyeth- Ayerst) in Healthy, adult, non-smoking subjects under non- fasting conditions.   "
227921|NCT00835406|"     The objective of this study is to compare the rate and extent of absorption of alendronate     sodium 70 mg tablets (test) versus Fosamax® 70 mg tablets (reference) administered as a     single dose of 70 mg under fasting conditions. A review of pharmacokinetic data demonstrates     Alendronate Sodium Tablets, 70 mg, manufactured and distributed by TEVA Pharmaceuticals USA     are bioequivalent to Fosamax® Tablets, 70 mg, manufactured by Merck Sharp & Dohme, USA.   "
227922|NCT00835419|"     The purpose of this study is to evaluate efficacy of P276-00 in subjects with advanced     malignant melanoma positive for cyclin D1 expression   "
227923|NCT00835432|"     Prospective randomized assessment of alveolar ridge alterations after augmenting dehisced     areas by applying principles of guided bone regeneration (GBR) subsequently to implant     installation.      Ossix as cross-linked and BioGide as non cross-linked degradable collagen membranes, both     used in combination with biphasic Calcium-Phosphate (BoneCeramic) as bone substitute.     Clinical measurements and impressions from the sites of interest are to be taken at the stage     of augmentation and 6 months after. At six months re-entry non-standardized biopsies from     augmented sites will be taken to determine newly grown tissue in quality and quantity.      Due to different degradation characteristics of the two collagen membranes used as barrier,     amount of newly formed mineralized tissue is suspected to vary in tests and controls,     respectively.   "
227942|NCT00836004|"     The objective of this study is to compare the rate and extent of absorption of clindamycin     300 mg capsules (test) versus Cleocin HCl (reference, administered as 1 x 300 mg capsule     under fed conditions.   "
227997|NCT00836745|"     The Sutent® Observational Study is being proposed to assess the real-world usage patterns and     effectiveness and tolerability of treatment of Indian patients with advanced renal cell     cancer with Sutent®. Generation of such information is expected to aid everyday clinical     decision-making by Indian doctors and will add to the body of generalizable evidence.   "
227924|NCT00835445|"     Background: Nasal polyps are found in about 5% of asthmatic patients.A close link exists     between the upper and lower airways and the concept of the United Airways has emerged     mainly from studies on allergic rhinitis and asthma. However, other upper airway diseases,     such as chronic sinusitis and nasal polyposis may influence lower airway diseases. As for     nasal polyposis, eosinophils are the major effector cells in asthma and have been associated     with a worsening of this condition.      Aim: To compare normal nasal mucosa and nasal polyp biopsies from subjects with nasal     polyposis with or without asthma.      Hypothesis: Nasal polyps from asthmatic subjects show a more aggressive pro-inflammatory     pattern of cytokine expression compared to nasal polyps from non asthmatic subjects, and     therefore contribute to the development and severity of asthma.   "
227925|NCT00835458|"     Background: T-shaped tissue anchors have promise to close incisions and perforations of the     intestines securely. The closure of perforations, gastro-gastric, or intestinal fistulas     usually requires invasive open or laparoscopic surgery under general anesthesia and can be     complex surgeries due to their reoperative or inflammatory nature.      Objective: The proposed use of full thickness tissue anchors adds a new surgical aspect to     the endoscopic treatment of fistulas and perforations by offering a robust suture like     closure of defects. Instead of a 20 cm abdominal incision or 3 or 4 one centimeter incisions     with the related postoperative morbidity an endoscopic technique is used which requires no     postoperative limitation of activities.      Methods: In this study the investigators propose to use an endoscopic technique that     eliminates the need for open or laparoscopic surgery and provides a more robust endoscopic     repair than is possible with traditional endoscopic tools. Patients who are scheduled to     undergo surgery for intestinal fistulas will be screened for study eligibility. Patients who     are scheduled to undergo complex polypectomy, or submucosal dissection will be screened for     study eligibility and informed about all possible therapies in case of an iatrogenic     perforation (open - laparoscopic surgery, endoscopic clipping, endoscopic closure with tissue     anchors). A commercially available flexible endoscope will be inserted through the mouth and     the fistula or perforation will be closed using the Tissue Approximation System (Ethicon Endo     Surgery, Cincinnati, OH).      The investigators will initially evaluate the potential benefit, risks and impact on the     patient's quality of life of this modified surgical technique in 5 patients.      Expected results: The potential advantages to the patients entered into this study result     from the avoidance of open or laparoscopic surgery with the related risks (bleeding, injury     of organs, post operative wound infection, hernia), shorter hospital stay, reduced     postoperative pain, earlier return to work, and cosmetic advantage.   "
227926|NCT00835471|"     The purpose of this study is to assess if the combination of erlotinib and chemotherapy     (docetaxel in case of squamous cell NSCLC or pemetrexed in case of other histological types)     is superior to erlotinib alone and has acceptable tolerability and safety in the 2nd line     treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC).   "
227927|NCT00835484|"     This study will compare the relative bioavailability (rate and extent of absorption) of 300     mg Cefdinir Capsules manufactured and distributed by TEVA pharmaceuticals USA with that of     OMNICEF® Capsules by CEPH International Corporation for Abbott Laboratories following a     single oral dose (1 x 300mg capsule) in healthy adult subjects administered under fasting     conditions.   "
227928|NCT00835822|"     The purpose of this study is to assess the therapeutic efficacy and safety of Venocur     Triplex®, administered BID for 60 days in patients with Chronic Venous Insufficiency rated     between CEAP 2 and 4, in comparison to a Placebo group.   "
227929|NCT00835835|"     This study is being done to test the possible benefits of gait-specific training using     body-weight supported, Lokomat assisted, treadmill training in people with Multiple     Sclerosis.   "
227930|NCT00835848|"     Both pre- and postconditioning seem to protect cardiomyocytes during reperfusion therapy.     Investigations both ex vivo and in vivo suggest that a gut derived hormone,     Glucagon-Like-Peptide-1 (GLP-1), is able to reduce reperfusioninjury after myocardial     ischemia. Results from our own laboratory have shown a marked reduction in infarct size when     rat hearts in a Langendorf preparation were exposed to the GLP-1 analogue, exendin-4. The     investigators want to investigate to what extent this effect can be translated to humans in     the setting of acute STEMI treated with primary PCI when evalutaed by cardiac magnetic     resonance imaging.   "
227931|NCT00835861|"     Many women come into pregnancy with diabetes that is controlled with either Metformin or diet     control; however, the current standard of care for the treatment of preexisting diabetes in     pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic     control, and has been used in pregnancy for other indications without adverse maternal or     fetal outcomes. What remains unproven is the ability of Metformin to adequately control     glucose in women during pregnancy.      Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by     either diet or an oral agent and women who are found to have an abnormal glucose challenge     test at less than 20 weeks to either standard treatment with weight based Regular and neutral     protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide     glycemic control that is equivalent to insulin in these women.   "
227932|NCT00835874|"     We hypothesize that supplementing maternal diet with probiotics will decrease the incidence     of feeding intolerance, necrotizing enterocolitis and sepsis in preterm infants fed     breastmilk.   "
227933|NCT00835887|"     In this study, the acute and long-term effects of flavanols on vascular function in patients     with ESRD will be investigated.   "
227934|NCT00835900|"     The purpose of this study is to explore the use of an prolonged alternative dosing schedule     using varenicline for smoking cessation leading to greater quit rates and higher rates of     continuous abstinence.   "
227935|NCT00835913|"     Severe sepsis and septic shock are causes of admission in intensive care units.Modification     of natriuretic peptid including NT-proBNP and cardiac autonomic nervous system alteration are     reported in sepsis shock and severe sepsis and seems to link to patient prognosis admitted to     intensive care units.   "
227936|NCT00835926|"     To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation     of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and     subjects aged ≥ 60 years.      To describe the immune response at 21 days following injection of the 2003-2004 formulation     of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and     subjects aged ≥ 60 years.   "
227937|NCT00835939|"     The purpose of this study is to determine whether sclerotherapy using a 25% dextrose and 1%     lidocaine solution is an efficacious treatment for patients with chronic Achilles     tendinopathy who have failed a home based, heavy load eccentric training program.   "
227938|NCT00835952|"     Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty   "
227939|NCT00835965|"     The combination of aprepitant and lower dose dexamethasone is superior to aprepitant alone     with respect to the proportion of patients with a complete response (no vomiting and no use     of rescue therapy) during 24 hours after the placement of last suture/staple.   "
227949|NCT00836095|"     Laryngeal mask airway is a widely used device in routine anesthesia for airway management     during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth     after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal     mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway     Supreme is a newer version of the laryngeal mask airway.      The research is being done to compare two variants of the laryngeal mask airway: the Proseal     laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the     newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned     than the older model, the Proseal laryngeal mask airway. Both models are approved for use by     the FDA, and are routinely used to assure the airway during general anesthesia.   "
227950|NCT00836108|"     Controlling the way people with lung problems breathe during arm exercises may reduce their     breathlessness during activities of daily living that require them to lift their arms (i.e.     brushing their hair, putting groceries away on high shelves). The main aim of this study is     to determine the effects of specific breathing strategies during arm exercise on dyspnoea in     patients with chronic lung disease. Coordinating inspiration with the action of arm elevation     will reduce dyspnoea during a rhythmic overhead arm activity   "
227951|NCT00836121|"     The investigators report a case of a 39-year-old man who presented an anterior mediastinal     cystic mature teratoma. Those kind of tumor contain elements derived from more than one of     the three primary germ layers (ectoderm, mesoderm, endoderm), frequently arranged in a     haphazard manner. They arise from totipotent cells and, therefore, are primarily found in     gonads, and more rarely in primitive cells kidnapped in other parts of the body. The tissues     are immature to well differentiated and foreign to the anatomic site. Mature teratomas are     either cystic or solid, although the cystic presentation predominates in gonadal sites.     Benign teratomas are the most common mediastinal germ cell tumor, accounting 70% of the     mediastinal germ cell tumors in children and 60% of those in adults. Immature teratomas are     potentially malignant tumors; their prognosis is influenced by the anatomic site of the     tumor, patient age, and the fraction of the tumor that is immature. Treatment of benign     mediastinal teratoma includes complete surgical resection, with results in a excellent     long-term cure rates. Complete resection of teratomas should be the goal of treatment.   "
227952|NCT00836134|"     The purpose of this study is to compare the effectiveness of local infiltration to an     ultrasound guided nerve block placed by the anesthesiologist for children undergoing     umbilical hernia repair.      This is a double-cohort, double blinded, randomized study comparing local infiltration to     ultrasound-guided rectus sheath block in children 1 to 17 years of age undergoing epigastric     or umbilical hernia repair.      We will first compare pain scores to see if one method is more adequate then the other in     providing post-op analgesia. Our second aim is to compare morphine consumption between the     two groups.      Our third aim is to measure the levels of local anesthetic in the blood following local     anesthetic infiltration or USGRSB.   "
227953|NCT00836147|"     This trial will explore the efficacy and safety of 250ng Juvista per Linear cm, administered     by intradermal injection following the excision of ear lobe keloids. Keloids commonly occur     after ear piercing and are usually bilateral.One ear lobe will be treated with Juvist and one     with placebo.   "
227954|NCT00836160|"     This is an observational prospective study that investigates only daily practice. The     prescription of anti-cancer medicine is separated from the decision to include the patient in     this study. In addition, the assignment of the patient to a particular therapy or therapeutic     strategy is not decided in advance by this study protocol, but falls within current practice.      The patient who fulfils eligible criteria will be enrolled when starts to receive the     second-line EGFR-TKI therapy. The frequency of tumor response evaluation by RECIST criteria     follows the investigator's discretion as daily practice.   "
227955|NCT00836173|"     The purpose of this study is to find out what effects, good and/or bad; rituximab,     ifosfamide, carboplatin and etoposide (RICE) followed by gallium nitrate, rituximab and     dexamethasone (GARD) have on diffuse large B cell lymphoma.      This research is being done to try to find a more effective treatment for this type of     cancer. We want to know whether treatment with rituximab, ifosfamide, carboplatin and     etoposide (RICE) then followed by gallium nitrate, rituximab and dexamethasone (GARD) will     improve survival.      Rituximab, ifosfamide, carboplatin and etoposide (RICE) are part of the usual treatment for     diffuse large B-cell lymphoma.      Gallium nitrate, rituximab and dexamethasone (GARD) in lymphoma is experimental.   "
227956|NCT00836186|"     To assess the magnitude and frequency of changes in chemo/cytokine expression in women     receiving radiation treatment. To asses the impact of race/ethnicity on the magnitude and     frequency of changes in chemo/cytokine expression during radiation therapy for breast cancer.     And finally to assess the interaction between radiation-induced chemo/cytokine expression     changes, and race/ethnicity, with respect to normal tissue reactions to radiation and     tumor-associated outcomes.   "
227957|NCT00836199|"     The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term     abstinence.   "
227967|NCT00836329|"     Preliminary studies have shown that people with diabetes who undergo heart surgery may have a     higher risk of developing cognitive functioning problems, including memory problems, than     people without diabetes who undergo heart surgery. Among people with diabetes, however, those     who control their blood sugar levels in a more intensive way during and after heart surgery     may have better neurological outcomes than those who use a standard method of controlling     their blood sugar levels. This study will compare the effectiveness of using a traditional     method of blood sugar control versus a more intensive method of blood sugar control during     and after heart surgery for improving neurological outcomes in people with diabetes.   "
227968|NCT00836342|"     The purpose of this study is to determine the difference of skin carotenoid levels between     subjects with previous squamous cell carcinomas (SCC), subjects with previous basal cell     carcinomas (BCC) and a control group.   "
247073|NCT01078246|"     The objective of this study is to monitor Health Outcomes of Interest (HOI) in participants     with human immunodeficiency virus-1 (HIV-1) infection following treatment with Raltegravir.   "
227998|NCT00836758|"     The purpose of this study is to compare the performance of a CPAP (continuous positive airway     pressure) device to a clinical polysomnography (PSG) in identifying breathing events in     patients with obstructive sleep apnea.   "
227958|NCT00836212|"     Background      Low concentrations of protease inhibitors (PIs) or nonnucleoside reverse transcriptase     inhibitors (NNRTIs) are associated with an increased risk of virological failure. Likewise,     excessive antiretroviral drug concentrations increase the risk of toxicity. Therapeutic drug     monitoring (TDM) may identify and correct excessively high or low PI and/or NNRTI     concentrations, and thus minimize toxicity and risk of treatment failure. Treatment     guidelines only recommend using TDM to help optimize ARV therapy in selected patients, and     there are no clear recommendations to guide the clinician who decides to adjust drug doses.     Prospective studies have demonstrated the relationship between EFV plasma concentration and     neuropsychiatric symptoms. Moreover, EFV is metabolized mainly by cytochrome P450 2B6 and its     concentration was reported to be associated with the CYP2B6 516GrT genetic polymorphism.      For drugs such as EFV or LPV/r, lower doses than the ones validated for standard clinical use     have demonstrated efficacy in dose-ranging studies.      The investigators will use a standardised algorithm to reduce doses in patients with plasma     EFV or LPV/r concentration above percentile 75. This algorithm is based on a Bayesian     approach from the pharmacology unit in Lausanne. The investigators hypothesize that a dosage     individualisation is feasible and safe.      2.2 Study Aims      The investigators aim at testing a simplified algorithm for dose reduction in patients with     documented virological efficacy, treated by a stable LPV/r or EFV based regimen with elevated     plasma concentration of these drugs.      Study Design      Prospective open label study in which all eligible patients screened with a plasma drug     concentration of either EFV or LPV/r above percentile 75 will be included. After confirmation     of the results at baseline, patients will be offered to decrease drug dosage by a third or a     half according to a standardised algorithm. All patients will undergo HIVRNA, biochemistry     and validated questionnaires after 3 and 6 months to assess the safety and the benefit of     this strategy.   "
227959|NCT00836225|"     The primary purpose of this trial is to assess the safety and tolerability of ISIS-SGLT2Rx     when given at increasing single doses and to assess the safety and tolerability of the same     doses when given multiple times.   "
227960|NCT00836238|"     The goal of this research study is to learn if your answers to questions during an interview     can help researchers predict how well you function physically and if you are at a high risk     for falls.      Primary Objectives:      -To determine how accurately a simple questionnaire can predict three objective measures of     function in elderly patients with prostate cancer.      Secondary Objectives:        -  To assess the correlations between three functional tests and the number of          self-reported falls in elderly patients with prostate cancer.        -  To determine risk factors related to number of falls in elderly prostate cancer          patients.   "
227961|NCT00836251|"     Aim 1: To evaluate the effect of antipsychotic treatment group on Activity Energy     Expenditure. The project hypothesizes that subjects treated with olanzapine will demonstrate     a greater decrease in AEE over time than subjects treated with ziprasidone, due at least in     part to sedating effects of olanzapine.      Aim 2: To evaluate the effect of antipsychotic treatment group on Energy Intake. The project     hypothesizes that subjects treated with olanzapine will demonstrate a greater increase in EI     over time than subjects treated with ziprasidone, based on higher histamine type 1 (H1)     receptor affinity of olanzapine and the relationship between H1 affinity and hunger and/or     satiety.   "
227962|NCT00836264|"     Intravenous (IV) morphine requirement for immediate postoperative pain control depends upon     the complex interplay of patient history, wound severity, environment, and genetics. Even for     relatively uniform stimulus intensity, such as that associated with tonsillectomy and     adenoidectomy (T&A), there can be marked individual variability in response to morphine. Some     patients are refractory to standard doses and need increased amounts. Others are sensitive,     require less drug to attain acceptable pain levels, and/or experience unwanted side effects     that limit dosing. A significant number must be switched to different analgesics altogether.     Despite the long clinical history of morphine as a postoperative analgesic, researchers have     only begun to examine the origins of response variability.      The investigators will look at 2000 retrospective Tonsillectomy and Adenoidectomy cases and     using this data and incorporating additional patient, surgical, and environmental factors     that may contribute to response variability, the investigators then propose a prospective     genome-wide association (GWA) study of 1500 children ages 4 to 18 y treated with IV morphine     sulfate for day surgery T&A.   "
227963|NCT00836277|"     This study proposes a single-arm, phase II study of irinotecan with panitumumab as     second-line therapy for patients with advanced esophageal adenocarcinoma. Efficacy will be     assessed by response rate, with an exploratory outcome endpoint of time to progression (as     panitumumab may result in prolonged stable disease). In addition to the usual safety     assessments, molecular correlates will be carried out in order to search for pharmacodynamic     and pharmacogenomic features that may correlate with response. Measures of host/patient     immune function will be assessed by evaluating the relationship between Fc receptor     polymorphisms and response in patients treated with panitumumab. Measures of EGFR protein and     phosphoprotein expression by immunohistochemical- (IHC-) staining, K-ras mutation status1 and     reverse-phase protein arrays (RPPA) and EGFR gene amplification by fluorescence in situ     hybridization (FISH) will be assessed as exploratory correlates.   "
227964|NCT00836290|"     Project PLUS tests an HIV risk reduction/adherence behavioral intervention with HIV-infected     individuals in Connecticut prisons. Participants are randomly assigned to one of three     groups: prior to release from incarceration (Group 1), after release from incarceration     (Group 2), and treatment-as-usual (Group 3). We hypothesize that the intervention groups     (Groups 1 & 2) will demonstrate significantly greater knowledge regarding drug- and sex-     related HIV risk behavior and HIV medication adherence, greater motivation to reduce HIV risk     behavior and improve HIV medication adherence, and enhanced skills for engaging in HIV risk     reduction behavior and HIV medication adherence vs. the treatment-as-usual group. We will     also compare these outcomes between Groups 1 and 2.   "
227965|NCT00836303|"     This study will assess the effectiveness of a culturally-responsive intervention to increase     colorectal cancer (CRC) screening among Latino immigrants in a primary care clinic setting of     a large municipal Hospital in New York City. propose a randomized, control trial to determine     if a video-based intervention, that educates and activates the patient and the provider via     the patient, will increase rates of CRC screening referrals compared to a control group.      Colorectal cancer remains one of the most prevalent cancers among the general population, as     well as in the Latino population, in the United States. There are serious disparities in CRC     screening rates between different races and socio-demographic populations (American Cancer     Society: Colorectal Cancer Facts and Figures - Special Edition 2005). Latino immigrants are     one of the populations most affected by the lack of screening, reducing their relative     benefit from preventive CRC services. This study will use a modified version of an     intervention developed and studied by Pignone (11), with changes made to be tailored     specifically to the Latino immigrant population. The outcomes measured will include referral     for CRC screening and adherence with providers' referrals. In addition, the investigators     will measure screening rates for other cancer screening tests to assess if the CRC     intervention displaces or facilitates other cancer screening. A sample of Latino immigrants     seeking care at the primary care clinic of Bellevue Hospital will be accrued through a     process of consecutive sampling until reaching the proposed sample size of 101 patients in     each group (alpha 0.05 and power of 80%). To analyze the effectiveness of the intervention     the investigators will use the z-test and will report the difference in proportion between     the intervention and the control group with a 95% CI, adjusting for intra-class correlations     and covariates. A repeated measurement analysis with logistic regression will be used to     examine the effects of covariates.   "
227969|NCT00836355|"     The purpose of this study is to investigate whether enoxaparin, minocycline, or both     medications in combination may help in recovery from acute stroke.      Enoxaparin (brand name Lovenox®) is a medication approved for use in humans to prevent and to     treat blood clots in deep veins in certain specific medical situations. Minocycline (brand     name Minocin®) is a tetracycline antibiotic approved to treat a number of bacterial     infections in humans. The investigators are studying these medications in acute human stroke     because they have each been separately shown to reduce the amount of injured brain tissue in     rats made to have acute ischemic stroke experimentally. In a human trial comparing     minocycline with placebo (a sugar pill) acute ischemic stroke patients who took minocycline     had better recovery after 1 week, 1 month and 3 months than patients who took placebo.   "
227970|NCT00836368|"     Purpose: This is a non-masked study with a primary endpoint of in vitro basophil activation     by the allergen D. farinae, comparing basophil activation before and after seven days of     supplementation. Secondary endpoints will include circulating antioxidant levels (tocopherols     and metabolites), in vitro basophil activation to IgG anti-IgE and to     N-formyl-methionyl-leucyl-phenylalanine (f-met-leu-phe), and monocyte and basophil     responsiveness to in vitro endotoxin challenge.      Participants: Twenty allergic asthmatic volunteers Procedures (methods): Volunteers will be     given 1200 mg of a gamma tocopherol enriched supplement, a commercially available supplement     form of vitamin E. Study participants will undergo assessment of general health, lung     function assessment, symptom scoring, and epicutaneous skin test to allergens at baseline and     after supplementation. Blood samples will be collected at baseline and after 7 days of     gamma-T treatment.   "
227971|NCT00836381|"     For many years, antimuscarinics have been first-line pharmacological treatment for OAB. A     recent meta-analysis of randomised, controlled trials on antimuscarinic treatment of OAB     concluded that the drugs provide significant improvements in OAB symptoms compared with     placebo but that the benefits are of limited clinical significance. The analysis questioned     the clinical significance of the trial results, one reason for which was the lack of data on     the use of sensitive patient-driven criteria. Traditional symptomatic and urodynamic measures     of treatment success may be meaningful to clinicians but often have little meaning to     patients. Therefore, patient-reported outcomes (PROs), which provide a subjective measure of     a patient's response to treatment, are useful. Recently, clinicians treating OAB have begun     to recognize the value of PROs but still overlook the treatment efficacy in terms of     patient-reported goal achievement (PGA).      Patients with OAB have combination of symptoms and the extent to which individual OAB     symptoms affect patients varies. Also each patient can have different goal for the treatment.     Therefore, assessing the degree of goal achievement in each patient can provide a new aspect     of treatment benefit.      This controlled study will advance the understanding of OAB in terms of patient-centered     treatments goals and goal achievement and will provide a new aspect of treatment benefit.   "
227972|NCT00836394|"     Juvenile idiopathic arthritis (JIA) is one of the most common chronic illnesses in children,     with recent data suggesting that 1 to 4 in 1000 Canadian children and youth cope with the     condition. Many JIA children will enter adulthood with permanent joint damage5. In parallel,     a significant number are affected by deficits of muscle function. In addition to the impact     on physical function, muscles play an important role in maintaining joint health. The overall     aim of this proposal is to evaluate a novel therapeutic intervention - whole body vibration     (WBV) - for its ability to improve muscle function and the biomechanics of lower extremity     joints in JIA in order to prevent joint degeneration.   "
227973|NCT00836407|"     Research Hypothesis: Ipilimumab (an antibody that blocks negative signals to T cells)     administered alone or in combination with a pancreatic cancer vaccine (allogeneic pancreatic     tumor cells transfected with a GM-CSF gene), has an acceptable safety profile in subjects     with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.      Primary Objective: To determine the safety profile of ipilimumab alone or in combination with     a pancreatic cancer vaccine in subjects with locally advanced, unresectable or metastatic     pancreatic adenocarcinoma.      Secondary Objectives:        -  To estimate overall survival (OS) which will serve as the primary efficacy signal.        -  To explore an association of T cell responses and immunological responses with OS in          patients receiving treatment.        -  To estimate overall response rate (ORR), immune related best overall response rate          (irBOR), progression free survival (PFS), and duration of response in patients receiving          treatment.        -  To explore an association between immune-related adverse events (IRAEs) and ORR.        -  To measure tumor marker kinetics (CA 19-9) in patients receiving treatment.   "
227974|NCT00836420|"     Patients with fulminant hepatic failure (FHF) often develop cerebral edema, high intracranial     pressure (ICP)that may result in fatal brain damage. The aim in this protocol is to determine     if a rise in the brain concentration of glutamate, lactate and pyruvate are involved in     development of surges of high ICP in patients with FHF. The study is observatory in nature     and also record the influence of any intervention that may e instituted during the course of     the critical illness.   "
227975|NCT00836433|"     This is a randomized trial of 2 nursing home staff educational approaches to reduce falls in     VA nursing home (CLC) residents. One is a traditional falls education program using web-based     modules, feedback of quality indicators, and meetings with influential peers. The other is a     12 week program that trains staff to form better connections and use effective communication     strategies with a diverse network of co-workers, so that problem solving about resident     problems is enhanced. The study will test whether the second intervention increases the     effectiveness of the traditional falls education program.   "
227989|NCT00836641|"     Asthma is a major health problem in preschool children. Infections by pneumococci a the most     frequent cause of airway infections, which tend to cause worsening of asthma. Vaccination     against pneumococci is recommended by scientific boards and the medical community, in order     to reduce the burden of disease. Data on the immunogenicity and safety of pneumococcal     immunization in preschool asthmatics are scarce.   "
227990|NCT00836654|"     The study will be performed to obtain further efficacy and safety data in order to obtain a     marketing authorization (pivotal study). In addition, health economic data are to be     collected.   "
227991|NCT00836667|"     The objective of this study is to compare the rate and extent of absorption of sertraline     hydrochloride 100 mg tablets (test) versus Zoloft® (reference) administered as 1 x 100 mg     tablet under fed conditions.   "
227976|NCT00836446|"     Childhood obesity is a public health problem; in Mexican children a high prevalence of     cardiovascular risk factors are present. Physical activity has been proposed as a strategy to     reduce this risk. We conducted a pre-posttest intervention study of 214 school-aged Mexican     children (4th to 6th grade), to assess the effects of two physical activity routines with     different duration and intensity (40 minute aerobic routine vs. 20 minute routine) on     cardiovascular risk markers. Physical activity routines were assigned randomly to two public     schools in Toluca, Mexico (20 min: group 1 (n= 117), 40 min: group 2 (n=97)). The routines     were implemented Monday through Friday for 12 weeks. Nutrition assessment was done before and     after the intervention and included anthropometric measurements (weight, height, body mass     index, waist circumference and body composition), blood pressure and biochemical analysis     (triglycerides, total cholesterol LDL-cholesterol, HDL-Cholesterol, glucose and insulin).     Heart rate was monitored 3 times during the intervention to evaluate the routine´s intensity.   "
227977|NCT00836459|"     Adults that increase their physical activity can improve their health, and reduce future     risks to health, but long−term changes are difficult to sustain. This study assesses whether     it is worth providing further support, 3 months after giving initial advice, to those who     have managed to do more physical activity. All participants will initially be given an     interactive DVD. A researcher from Sheffield Hallam University will provide two telephone     follow ups at one month intervals to assess physical activity levels. Only those that have     increased their physical activity at this point will remain in the study. These participants     will receive a mini booster, a full booster or no booster. The mini booster consists of     a two telephone calls one month apart to discuss physical activity and usage of the DVD. A     full booster consists of a face−to−face meeting with the facilitator at the same intervals.     The purpose of these booster sessions is to help the individual to maintain their increase in     physical activity. The investigators will measure the differences in physical activity,     quality of life and costs, associated with the booster interventions, 3 months and 9 months     from randomisation. The research will be carried out in 20 of the most deprived     neighbourhoods in Sheffield. These locations have large, ethnically diverse populations, high     levels of economic deprivation, low levels of physical activity, poorer health and shorter     life expectancy. Participants will be recruited through general practices and community     groups, as well as by postal invitation to ensure the participation of minority ethnic groups     and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a     range of facilities and activities to promote physical activity and variations in access to     these between neighbourhoods will make it possible to examine whether the effectiveness of     the intervention is modified by access to community facilities.   "
227978|NCT00836472|"     The objective of this study is to compare the rate and extent of absorption of     Glyburide/Metformin 5 mg/500 mg film-coated tablets (test) versus Glucovance® (reference)     administered as 1 x 5 mg/500 mg film-coated tablet under fasting conditions.   "
227979|NCT00836485|"     This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be     evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.   "
227980|NCT00836498|"     This is a Phase I clinical trial including 2 parts to evaluate the safety and immune response     to RotaTeq™ /placebo in subjects of 65 to 80 years of age. In Part I, approximately 60     subjects in US will be randomly assigned to 1 of 2 treatment groups receiving 3 doses of     RotaTeq™ or placebo. In Part II, approximately 200 subjects internationally will be randomly     assigned to 1 of 3 treatment groups. Part II will start after Part I data analysis is     reviewed and approved by the FDA/CBER, the Safety Evaluation Committee (SEC) and other     regulatory agencies. Duration for the entire study will be approximately 4 years.      Note: As the result of a business decision by the Sponsor, the study did not proceed with     Part II. Therefore, this report includes the results for Part I only.   "
227981|NCT00836524|"     Objective: To investigate the role of maternal serum YKL-40 and uterine artery doppler, at     gestational age 12, 20, 25 and 32 weeks, and the relation to preeclampsia and intrauterine     growth restriction. The serum marker YKL-40 is related to conditions involving inflammation,     infection, tissue remodeling, fibrosis and cancer. IUGR and preeclampsia are known to be     related to inflammation and tissue remodeling.      Methods: women attending screening for downs syndrome is scanned with uterine artery doppler     and delivered blood samples at GA 12, 20, 25 and 32 respectively. When pregnancy outcome is     registered by medical records blood samples are retrieved and analyzed for serum YKL-40.     Serum YKL-40 are correlated to the presence of bilateral notching, preeclampsia and different     degrees of intrauterine growth restriction.   "
227982|NCT00836537|"     This study will compare the relative bioavailability (rate and extent of absorption) of 40 mg     Benazepril Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 40 mg     LOTENSIN® Tablets by Novartis Pharmaceuticals following a single oral dose (1 x 40 mg) in     healthy adult volunteers under non-fasting conditions.   "
227983|NCT00836550|"     This study evaluated the educational effectiveness of a youth-friendly pre-test video     (derived from a previous qualitative study) and compared it with in-person HIV pre-test     counseling. A convenience sample of 200 medically stable individuals between the ages of 15     and 21 presenting to an urban ED were recruited to participate in this study and randomized     into 2 groups. Individuals were eligible if they were English-speaking, sexually active and     able to consent. All participants completed a sexual risk factor and demographic survey.     Group 1 completed a validated pre-test knowledge measure, viewed the HIV education video then     completed a post-test knowledge measure. Group 2 completed the same knowledge measures, but     received pre-test HIV counseling from a trained public health advocate. HIV testing was     optional   "
227984|NCT00836563|"     The purpose of this study is to determine whether upper arm vessels increase in size     following forearm loop arteriovenous graft placement, and if they do, characterize the timing     of these changes   "
227985|NCT00836576|"     The objective of this randomized, single-dose, two-way crossover evaluation is to compare the     oral bioavailability of a test benazepril HCl formulation (TEVA Pharmaceutical Industries     Ltd.) to an equivalent oral dose of the commercially available benazepril HCl (Lotensin®,     Novartis Pharmaceuticals Corporation) in a test population of 40 adults under fasting     conditions.   "
227986|NCT00836589|"     The objective of this study is to confirm the long-term safety and reliability of the Linox     Lead System as used with BIOTRONIK ICDs. The GALAXY registry will provide data to fully     characterize ICD lead failures, from implant through 5 years, including those failures     contributing to patients losing pacing or defibrillation therapy.   "
227987|NCT00836602|"     The primary purpose of this study is to evaluate the safety and tolerability of multiple oral     doses of BMS-779788 in healthy subjects   "
227988|NCT00836628|"     This protocol is aimed at establishing a maximum tolerated dose (MTD) for submyeloablative     doses of Busulfex ® with the hope that a tolerable, submyeloablative dose can be established     to test efficacy as alternative therapy for refractory pediatric brain tumors.   "
228001|NCT00836797|"     After extraction of a tooth, the bony socket heals naturally but due to the absent of the     tooth and any presence of support in the socket, bone resorption occur both vertically and     bucco lingually or bucco palataly. This bony resorption ultimately effects a lot of things     like - the support for the adjacent teeth become weak, the shallow ridge makes it difficult     for future prosthesis retention, and less bony support for any implant placement in the     future which is the most popular and effective way of tooth replacement now a days. So now a     days keeping the integrity and contour of the alveolar bony socket is very important for the     patients future rehabilitation. The use of scaffold will help to maintain the integrity of     the alveolar bony socket thus provides a vital support for the adjacent teeth, preserve the     alveolar crest height, maintain the bony contour, helps to prevent bleeding, and most     importantly it will help in bone regeneration which is the vital factor for future     rehabilitation.   "
228002|NCT00836810|"     Polymyalgia Rheumatica (PMR) is a disease that usually affects older people. Patients     complain of stiffness and pain around the shoulders and hips. The stiffness is more severe in     the morning. The joints are not affected by this disease.      Research in Rheumatoid Arthritis (RA), which is also much worse in the mornings, has shown     that IL−6 (a chemical messenger) peaks in the morning with very low levels in the evening.     This may explain why stiffness is most severe in the morning. The investigators have recently     shown that timed release tablet (TRT) prednisone reduced morning IL−6 levels close to normal     in RA patients.      In PMR, IL−6 levels are high. Given that both RA and PMR have the same variation of symptoms     (worse in the morning); it's likely that PMR patients have the same variation in IL−6 levels.     In a pilot study of 4 patients conducted within our department, IL−6 levels did, indeed, show     a pattern similar to that found in RA patients, but the number of patients is small and the     results need to be confirmed.      PMR is treated with moderate doses of glucocorticoid for about 2 years. While generally     abolishing symptoms, these doses are very likely to cause adverse effects such as high blood     pressure, weight gain and diabetes. These side effects are much less frequent when lower     doses are used but these are not sufficient to control PMR using traditional dosing regimes.      Therefore, the investigators wish to investigate whether TRT prednisone in PMR will reduce     IL−6 and morning symptoms similar to those in RA. The investigators think that it will do so,     and will achieve symptomatic relief at a lower dose. If this is the case, then treating     patients with lower doses may mean reduced risk of glucocorticoid induced side effects in the     future.      Patients will be recruited through the outpatient clinics at the University Hospitals     Bristol, NHS Foundation Trust, Rheumatology Centre. Each patient will give fully informed     consent after being given details of the study and a patient information sheet. The research     doctor will take the consent 2−5 days after this information has been provided and with the     presence of a witness. The study will consist of the collection and analysis of sequential     blood samples over a 24 hour period on 2 occasions 2 weeks apart, taking TRT prednisone 7 mg     / standard release prednisolone 7 mg for the intervening period. The investigators will aim     to recruit 12 patients in each arm. A single blood sample will be taken when the patient     comes for a routine review 2 weeks later.   "
228003|NCT00836823|"     Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) consists     of a constellation of symptoms (including voiding, storage, and post-micturition). The impact     of the LUTS on patients' health-related quality of life is substantial and multifaceted.     Thus, the therapies aimed at treating BPH are concerned primarily with improving patients'     symptoms, thereby improving quality of life. When multiple symptoms are present, the level of     bother associated with individual symptoms varies and patients prioritize their treatment     goals for symptom relief. A measure that addresses patients' most bothersome symptoms (MBS)     and evaluation of symptom-specific goal achievements may lead to improved outcomes and     patient satisfaction to the treatment. The objectives of this study were (1) to assess     patient-reported MBS and symptom-specific goal achievements (PGA) with medical treatment in     BPH patients, and (2) to identify factors that influence or have relation to the PGA.   "
228045|NCT00837369|"     To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of     the A2A Receptor agonist Regadenoson for detection of significant coronary artery disease     (CAD) in patients scheduled to undergo coronary angiography. Sensitivity, specificity , and     accuracy of perfusion and wall motion analysis to identify a coronary stenosis> 50% in     diameter by quantitive angiography will be analyzed   "
228091|NCT00837967|"     The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler®     160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on     top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma     patients.   "
228004|NCT00836836|"     Seizures are a frequent cause of morbidity in the pediatric age group. Uncontrolled seizures     pose a variety of risks to children, including higher rates of mortality, developmental delay     and/or regression, and cognitive impairment. The ketogenic diet is a well known treatment     option for refractory epilepsy. However it is very restrictive and requires strict weighing     of foods. The modified Atkins diet is a dietary therapy for intractable childhood epilepsy     that was designed to be a less restrictive alternative to the traditional ketogenic diet.     Early studies have demonstrated efficacy and safety.There are no randomized trials evaluating     the efficacy of the modified Atkins diet in children with refractory epilepsy. Hence this     study has been planned to investigate whether there are clear benefits in terms of seizure     control in children with refractory epilepsy who are treated with the modified Atkins diet,     versus controls.   "
228005|NCT00836849|"     The objective of this study is to compare the rate and extent of absorption of sertraline     hydrochloride 100 mg tablets (test) versus Zoloft® (reference) administered as 1 x 100 mg     tablet under fasting conditions.   "
228006|NCT00836862|"     This project will bank sera, DNA and vascular specimens from patients undergoing     arteriovenous fistula creation and revision   "
228007|NCT00836875|"     The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal     drug) when used in children who have invasive aspergillosis (IA) and other rare systemic     fungal infections.   "
228008|NCT00836888|"     Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and     multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and     exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.   "
228009|NCT00836901|"     The objective of this study is to compare the rate and extent of absorption of     amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin®     (reference) administered as 1 x 400 mg-57 mg chewable tablet under fed conditions.   "
228010|NCT00836914|"     The purpose of this study is to determine the safety and effect of CAL-101 in subjects with     allergic rhinitis.   "
228011|NCT00836927|"     To describe the long-term safety of deforolimus in patients for whom a clinical benefit has     been established in a prior parent trial with deforolimus and/or in those who remain in     long-term follow-up.   "
229201|NCT00853346|"     The purpose of the study is to examine the effects of a form of talk therapy called cognitive     behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's     disease (PD).   "
228012|NCT00836940|"     The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus     patients.      The study involves six weeks of wash out period and two weeks run in period for patients     currently on mono-therapy and a two week run in period only for drug naïve patients.      This is a placebo controlled study. One of the five treatment arms is placebo. The duration     of treatment is 12 weeks.   "
228013|NCT00836953|"     To describe the safety findings from Days 0 to 44 following injection of the 2003-2004     pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in     the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to <     36 months.      To describe the immunogenicity findings from Days 0 to 44 following injection of the     2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®,     given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6     months to < 36 months   "
228014|NCT00836966|"     The diagnosis of clinically-significant meniscal tears of the knee remains challenging, and     it is unknown why only some injuries become painful. The limitations of diagnostic magnetic     resonance imaging result in arthroscopy that is not always beneficial. Elucidation of     biochemical pathways underlying pain in this condition may aid patient selection for surgery     and provide pharmacotherapeutic targets. Cytokines may be involved in pain following meniscus     injury and diagnostic cytokine assay may help physicians differentiate patients that may     benefit from arthroscopy from those that may not.   "
228015|NCT00836979|"     This study is a continuation or follow-up of two previous studies (RRISK and RRISK2)     conducted at the Kaiser Division of Research. This study will invite previous study     participants, as well as a randomly selected group of Northern California Kaiser Permanente     Members, to participate in an interview, mailed survey and lab visit. The purpose of this     study is to examine the risk factors for bladder and pelvic problems.   "
228016|NCT00836992|"     RATIONALE: Gathering information about patients' quality of life during radiation therapy for     cancer may help doctors plan the best treatment.      PURPOSE: This randomized clinical trial is studying quality of life in patients undergoing     radiation therapy for primary lung cancer, head and neck cancer, or gastrointestinal cancer.   "
228017|NCT00837005|"     High-dose dobutamine/atropine stress cardiac magnetic resonance imaging (DS-MRI) has been     incorporated in daily clinical practice for the detection of ischemic heart disease.      Thus, wall motion abnormalities (WMA) during stress, precede the development of ST-segment     depression on ECG and of anginal symptoms and aid in the detection of anatomically     significant coronary artery disease (CAD).      DS-MRI offers the possibility to integrate myocardial perfusion and wall motion analysis in a     single examination. In this regard, recent data suggest that the assessment of myocardial     wall motion and perfusion during a single session may enhance the sensitivity of the     technique for the diagnosis of CAD.      However, to date limited data is available on the prognostic value of high-dose DS-MRI in     large patient cohorts, treated according to current guidelines.      Assessment of long-term outcome of DS-MRI is important because this test may identify both     high-risk patients, who would benefit from invasive diagnostic and therapy, and lower-risk     patients in whom additional procedures and intensive medical follow-up are not required.      In the present study we aim to determine the value of wall motion and perfusion assessment     during high-dose dobutamine/atropine MRI in predicting cardiac events.      In addition, the incremental value of the MR-stress testing results was assessed (inducible     wall motion, perfusion abnormalities and the combination of both) after the consideration of     traditional clinical risk factors and baseline ejection fraction.   "
228080|NCT00837824|"     This study was designed to determine appropriate treatment with Fabrazyme at a biweekly dose     of either 1 mg/kg or 3 mg/kg in a population of patients with severe renal disease burden.   "
228081|NCT00837837|"     The purpose of this study is to examine the pharmacokinetic parameters of chlorpheniramine in     children and adolescents.   "
228082|NCT00837850|"     A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone     cements.   "
228018|NCT00837018|"     The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to     4% of the general population. The patients with OSAS frequently complain of intolerance to     exercise muscle fatigue and a significant even if they have not been fully characterized in     the literature.      The anomalies in the exercise of patients with OSAS could be due to metabolic changes     (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity).      Our goal is both to determine whether these anomalies exist in patients with OSAS not obese,     consider their relationship with the alteration of exercise capacity, and their reversibility     in conventional PPC or by using the effects of physical activity regular.In this study     Objectives: To establish whether the metabolic and vascular abnormalities associated with     OSAS are associated with decreased parameters of physical fitness in relation to witnesses     matched for age, sex and body mass index. Determine the effects of a re-training exercise on     these parameters compared to the reference treatment, continuous positive pressure.      Main objective: To compare the exercise capacity of OSAS patients compared with that of     witnesses matched for age, sex and body mass index.      Secondary objectives: To compare the effect of conventional treatment by continuous positive     pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic     modality most original, physical activity.      Methodology: Test physiopathological parallel group, controlled, randomized.   "
228019|NCT00837031|"     To evaluate the 6-month overall survival, safety, and tolerability of lenalidomide in     combination with standard gemcitabine as first-line treatment for patients with metastatic     pancreatic cancer.   "
228047|NCT00837395|"     A small number of women with asthma have an increase in asthma symptoms during the     premenstrual or menstrual period. This study is being done to investigate the possible causes     of this premenstrual increase in asthma symptoms and to help asthma care providers identify     those patients who may suffer from this condition.   "
228058|NCT00837538|"     The SpinalMouse is a computer-assisted medical device that measures and graphically reports     on posture and range of motion of the axial spine. The data has shown to be highly valid and     reproducible while compared to x-ray film. The aim of the study is to evaluate if the Spinal     Mouse is a reliable clinical diagnostic device to screen those patients having instability in     the lumbar area.   "
228020|NCT00837044|"     Migraine headache occurs frequently in women more than men and is associated with symptoms     not only of significant pain but also of symptoms typically including of photophobia,     phonophobia, nausea and vomiting. Many migraine patients report difficulty in cognition from     lack of concentration, difficulty in word finding or inability to remember. Many of these     cognitive symptoms seem to be independent of the pain intensity and may occur completely     separately from the headache pain but can be disabling. It is likely that the frequency and     importance of cognitive symptoms associated with migraine are underreported.      The Mental Efficacy Workload Test (MEWT) is a computerized battery that is designed to be an     efficient and accurate measure of cognition during migraine headache. Treximet is a new     migraine treatment recently FDA approved for the treatment for the relief of acute migraine     that may be effective for the cognitive symptoms for migraine patients who have a history of     cognitive dysfunction during a migraine headache. The primary efficacy parameter is to     evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute     migraine headache measuring neuropsychological function using the MEWT during the migraine     and comparing that score with a prior MEWT score when the patient had no migraine symptoms. A     double blind, placebo-controlled, crossover study was chosen so that each patient may be her     or his own control.      It is the intent of this study to determine the type and intensity of cognitive dysfunction     associated with migraine headache and to what extent that Treximet may relieve the cognitive     dysfunction in a safe and effective manner.   "
228021|NCT00837057|"     Severe sepsis or septic shock with acute kidney injury shows high mortality in intensive care     unit. A few studies have shown CRRT relating the clinical improvement seems to be related to     the early initiation of therapy. But there is no consensus for proper time of CRRT may     improve the prognosis.      The study is a prospective randomized one center trial comparing two treatments in patients     suffering from septic shock complicated with acute renal failure admitted to ICU, treated     either early by CRRT (35 ml/kg/h) or by conventional RRT.   "
228022|NCT00837070|"     Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. These cysts can be     cured by a minimally invasive technique: percutaneous cyst distention and rupture   "
228023|NCT00837083|"     This open label, non-interventional study is to show the efficacy of Crestor (rosuvastatin)     in reduction of LDL-cholesterol and cardiovascular risk parameters in patients with     hypercholesterolemia. Effectiveness is to be evaluated using the difference in LDL     cholesterol level between the first and the second visit after 12 weeks.   "
228024|NCT00837096|"     The objective of this study is to thoroughly examine the role of V.A.C. NPWT in the further     salvage of the diabetic foot once it has undergone partial amputation. To determine this,     measures of healing, quality of life, and utilization costs associated with this approach     will be analyzed. KCI believes that information obtained from this study will show V.A.C.     NPWT can support efforts involving limb salvage of the diabetic foot, helping an effective,     cost-efficient healthcare solution.   "
228025|NCT00837109|"     Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in     veterans, and that trauma-related nightmares and sleep disturbances are common in veterans     with PTSD. This is of concern because people with these problems will often use unhealthy     ways of coping. Although trauma-related nightmares and difficulty sleeping are highly     distressing, there are helpful treatments that do not involve taking medication. One of these     treatments teaches specific skills to help people improve their sleep habits and to change     their nightmares so that they are less upsetting. This treatment can be very helpful and     research shows that people experience decreases in the frequency and severity of their     nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and     quantity after completing treatment. However, because this treatment has only been studied     with civilians, it is not clear how well this treatment works for veterans.   "
228083|NCT00837863|"     The purpose of the study is to evaluate the safety and effectiveness of ALTU-238 in the     treatment of children with growth hormone deficiency who have not yet reached puberty who     lack the normal ability to make growth hormone themselves. This study will also test if     ALTU-238 works as a weekly treatment.   "
228084|NCT00837876|"     RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking     blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib     works in treating patients with pancreatic cancer that cannot be removed by surgery.   "
228135|NCT00832221|"     The aim of this study is to relate pharmacokinetics of two different formulations of     quetiapine to PET measured receptor occupancy in the brains of healthy subjects.   "
228026|NCT00837122|"     Background:        -  Type 2 diabetes (T2D) and associated complications are major contributors to the global          disease burden. T2D is already a major health threat in populations in developed          countries and is rapidly taking hold in the developing world.        -  It is believed that understanding the complex interplay between genetic and lifestyle          characteristics in the etiology of T2D and related complications will lead to the          development of better preventive and therapeutic strategies. In Addition, the results of          this project will facilitate our understanding of causes of diabetes in African          Americans, other US and world populations      Objectives:        -  To conduct a genome-wide association study (GWAS) to identify susceptibility genetic          variants for diabetes among the Yoruba people in Ibadan, Nigeria.        -  To enroll and examine 300 unrelated cases of T2D and 300 ethnicity-matched Yoruba          controls.        -  To conduct resequencing of positional candidate gene/loci to identify likely functional          variants in a subset of the cohort.        -  To conduct replication studies of the top-100 scoring variants in three independent          African and European ancestry samples.        -  To investigate whether diabetes-associated variants discovered in European populations          increase diabetes risk in West Africans.      Eligibility:        -  Patients 25 years of age with confirmed T2D who are newly diagnosed or on treatment of          Yoruba ethnicity in Ibadan, Nigeria. Control subjects are nondiabetics ethnically          matched to patients.      Design:        -  The study design for both patients and controls consists of the following steps:        -  Discuss informed consent process and obtain signed informed consent form. Informed          consent will be administered by trained clinic staff.        -  Assign study ID (barcode)        -  Administer questionnaires        -  Obtain spot urine sample        -  Measure blood pressure        -  Obtain anthropometric measurements including body composition        -  Perform finger prick for blood glucose level        -  Obtain venous blood samples        -  Perform eye examination        -  On the following day, perform confirmatory blood glucose for the small subset of          participants requiring confirmation of previous test result DNA extraction of stored          samples will be done at either the National Institutes of Health or the laboratory in          Nigeria.        -  GWAS will be conducted using publicly available software packages.   "
228055|NCT00837499|"     The goal of this epidemiologic research study is to find out if various risk factors and     certain markers (substances that help identify the presence of cancer) that help predict     increased occurrence and prognosis (outcome of disease) of breast cancer differ among     Mexican, Mexican-American, and African-American women.   "
228027|NCT00837135|"     The purpose of this study is to determine if it is safe to add multiple immunotherapies to     standard chemotherapy and radiation for treating pancreatic cancer tumors that cannot be     completely removed by surgery.        1. GI-4000 Vaccination:           The first involves a vaccine, which is an injection (shot) that teaches your immune          system to attack foreign invaders. The vaccine we will use is called GI-4000 - a          vaccine composed of yeast that is made to carry the same proteins (called mutated Ras          proteins) found in some pancreatic cancer cells.        2. Adoptive T-cell Transfer:      The second type of immunotherapy in this study is called adoptive T-cell transfer. This     involves collecting a specific type of white blood cells from you (called T-cells)and     growing T-cells grown in a lab which may help the research participants' immune systems     recover more quickly after chemotherapy, and possibly improved response to other     immunotherapies.      We hope that studying these agents together will teach us how to help the immune system fight     pancreatic cancer.   "
228028|NCT00837148|"     The purpose of this study is to find out what effects, good and/or bad, the combination of     sorafenib and dacarbazine has on sarcoma. Recurrent sarcoma is difficult to treat. Standard     chemotherapy drugs can be toxic, and the length of benefit is usually short. As a result, we     need new treatments for sarcoma. Sorafenib is a new type of targeted chemotherapy that     attacks specific proteins (including raf and VEGF receptor) in cells. We hope that by     blocking these proteins we can cause the tumor to shrink. Sorafenib is also known as BAY     43-9006 and by the trade name Nexavar®. The FDA approved sorafenib in December of 2005 to     treat patients with kidney cancer and in November of 2007 to treat patients with liver     cancer. This drug is not approved by the U.S. Food and Drug Administration (FDA) or any other     licensing authority for the treatment of sarcoma and is therefore considered to be     experimental in this setting.   "
228029|NCT00837161|"     Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in     reproductive aged women and are the most common cause of hysterectomy in the United States.     Women are seeking new ways to treat symptomatic uterine fibroids that allow them to avoid     surgery. This study is the first step in this quest. We will study the novel use of magnetic     resonance imaging (MRI) in enhancing the safety of the FDA approved technique to treat     fibroids called High Intensity Focused Ultrasound (HIFU). The term 'high intensity focused     ultrasound' means using ultrasound to heat and to thermally destroy tissue, in this case,     uterine fibroids. The MRI system will allow us to watch the ultrasound path during treatment     and monitor the temperature increase in the fibroid tissue that comes during the procedure.      In this pilot study, women with symptomatic fibroids will undergo MRI guided HIFU and then     have a hysterectomy. This will allow us to confirm studies done in animals which show that it     is possible to destroy specific tissue without harming normal tissue surrounding the targeted     area.      The purpose of this clinical study is to confirm the safety and treatment capabilities of the     Philips MR guided HIFU system for ablation of uterine fibroids. This is a single arm pilot     study of 10 women who will undergo hysterectomy after the HIFU procedure. This study design     of hysterectomy after treatment has been requested by the FDA as part of IDE approval for     this new device and mirrors what has been required for similar devices. Safety will be     assessed by evaluating treatment accuracy, complications, and adverse events. Treatment     capabilities will be assessed by evaluating the fibroid volume ablated and other factors     related to the procedure feasibility and acceptance including procedure duration, time to     return to normal activity, and pain scores at the time of the procedure.      Study population      The Philips MR-HIFU System is intended for ablation of uterine fibroid tissue in pre- or     perimenopausal women with symptomatic uterine fibroids who desire a uterine-sparing     procedure. Patients must have completed child bearing prior to enrolling in this study.     Patients will be recruited by referral to gynecology and interventional radiology at the NIH     Clinical Center. Candidates for enrollment will already have symptomatic uterine leiomyomas     and be willing to undergo hysterectomy for treatment. It is estimated that of apparently     eligible subjects, at least 30 women will have to be screened in person in order to identify     10 who will be eligible for this study. Other studies of fibroid treatments are currently     ongoing at the NIH. Women who have been interested in, but have not been selected for     enrollment in those studies and who appear to be eligible to this study will be contacted for     potential enrollment.      Study design:      This study is a multi-center, single arm trial evaluating the safety and treatment     capabilities of the Philips MR-guided HIFU system in the treatment of symptomatic uterine     fibroid patients who are otherwise healthy women. All patients enrolled in the study will     undergo hysterectomy within a window of 30 days following HIFU treatment. Patients who have     symptomatic uterine fibroids, meet clinical indications for hysterectomy, are eligible     according to the inclusion and exclusion criteria and provide informed consent will be     enrolled in this study. This study design of treatment followed by hysterectomy has been     requested by the FDA as part of IDE approval for this new device and mirrors what has been     required for similar devices. It is anticipated that women will participate in the study for     a 3 month period to include the screening, HIFU treatment, hysterectomy and post hysterectomy     follow-up.      The methodology used for this HIFU device capitalizes on the thermal properties of volumetric     ablation rather than point ablation used by other focused ultrasound systems. Thus it is     anticipated that this device will have a shorter treatment time compared to other HIFU     machines. This HIFU system, via real-time MR thermometry monitoring, has automated thermal     feedback during the procedure which may enhance safety. This pilot study will not only assess     the safety of this device but will enable us to delineate the treatment capabilities of this     system for future use in patients who want uterine sparing non-surgical treatment for     symptomatic fibroids.   "
228030|NCT00837174|"     The purpose of this study is to determine the rate of response to the drugs bortezomib     (Velcade) and vorinostat (Zolinza), when used in combination, in patients with relapsed     (recurrent) and/or refractory (difficult to treat) non-Hodgkin Lymphoma, and to determine the     safety and tolerability of this regimen.   "
228031|NCT00837187|"     In a recent study by Yuen et al it was shown that preoperative intranasal administration of     dexmedetomidine is a useful alternative for oral midazolam in children. However, there is no     information on the pharmacokinetics of dexmedetomidine after intranasal administration.      The aim of this study is to investigate the comparative pharmacokinetics of intranasally and     intravenously administered dexmedetomidine in healthy volunteers. The absolute     bioavailability of intranasally administered dexmedetomidine will be calculated. In addition,     we will report the effects of intranasally and intravenously administered dexmedetomidine on     plasma catecholamine levels, systemic blood pressure, heart rate and sedation. We will also     monitor the local and systemic safety and tolerability of intranasally administered     dexmedetomidine.   "
228032|NCT00837200|"     This is an exploratory study to study the efficacy of combination regimen of     Oncaspar/Doxil/Decadron (ODD) in patients with refractory lymphoid malignancies. Patients     with any form of lymphoid malignancy will be eligible: acute lymphoblastic leukemia, chronic     lymphocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma and plasma     cell leukemia. Patients must have failed standard regimens for their cancers and could have     had unlimited number of prior regimens. Patients will be staged appropriately for their     disease with clinical examination, laboratory tests, and imaging studies. Both Oncaspar and     Doxil will be given on day 1 and 15. Patients will be clinically evaluated prior to each     cycle and will have disease assessments every 2 cycles. Responding patients will continue     therapy until disease progression or excessive toxicity. Responders who are candidates for     allogenic stem cell transplantation could go to conditioning chemotherapy and stem cell     transplant after 4 cycles of ODD.   "
228033|NCT00837213|"     To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin     vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of     moderate acne   "
228034|NCT00837226|"     The purpose of this study is to determine if there is an effect on the eye pressure from     extreme weight loss by bariatric procedures. The hypothesis is that excess fat in the orbit     of the eye compresses on the outflow system, which causes an elevated eye pressure. This can     have many consequences, including the risk for glaucoma. We hope to establish if there is an     effect between eye pressure and weight.   "
228085|NCT00837889|"     The aim of the present study is threefold: investigating 1) specific cognitive impairments in     patients with congestive heart failure, 2) whether cognitive impairments in patients with     decompensated heart failure improve after medical recompensation and 3) whether cognitive     functioning is related to the long-term prognosis (mortality, rehospitalisation) of those     patients.   "
228086|NCT00837902|"     The overall goal of this project is to determine the genetic factors contributing to     interindividual differences in response to beta-blockade.   "
228035|NCT00837239|"     This protocol is part of a larger grant funded by the NCI to create an international research     center to study traditional Chinese medicine (TCM). All of the patients enrolled in this     study will be treated at the Cancer Hospital, Fudan University, our sister institution in     Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the     Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance     through the U.S. Department of Health & Human Services (Approved: April 25, 2002). The     research nurses have received training at MDACC and will receive regular oversight by MDACC     personnel.      Primary End Point:      1. Determine the efficacy of huachansu as measured by progression free survival at 4 months.      Secondary End Points:        1. Examine the feasibility and safety of treatment using huachansu in combination with          gemcitabine in patients with pancreatic cancer.        2. Determine clinical efficacy by other measures including tumor response, 6-month          survival, and changes in quality of life (QOL) in patients with pancreatic cancer.        3. Monitor patient blood levels of the three main cardiac glycosides that are in huachansu          (bufalin, cinobufagin, and resibufogenin). This information will provide evidence to          delineate the role of these cardiac glycosides in antitumor activity.   "
228056|NCT00837512|"     The goal of this study is to determine if microneedles can effectively and painlessly deliver     insulin to children and young adults with type 1 diabetes.   "
228036|NCT00837252|"     Central serous chorioretinopathy (CSC) is a retinal disorder characterized by an accumulation     of serous fluid under the retina. Although acute CSC tends to spontaneously resolve on its     own with minimal sequelae, chronic CSC tends to persist and lead to irreversible visual loss.     The pathogenesis of CSC is complex; however, systemic androgens have been implicated.     Finasteride is an anti-androgen medication that is widely used in the treatment of various     conditions. The objective of this study was to investigate the safety and potential efficacy     of oral finasteride as a treatment for chronic CSC.      Five participants with chronic CSC were enrolled into this uncontrolled, unmasked, Phase I/II     study. An oral dose of finasteride, 5 mg daily, was administered to all participants for     three months.      Following this, finasteride was withheld and participants were observed for another three     months. If a participant experienced a beneficial effect during the period in which he     received finasteride and then experienced a relapse during the observation period,     finasteride was re-instituted for the remaining period of the study. Relapse was defined as a     return to the baseline maximum lesion height and/or return to baseline lesion volume.   "
228037|NCT00837265|"     Determination of the effect of Neugranin on the duration and severity of severe neutropenia.   "
228038|NCT00837278|"     The objective of the study is to compare maternal levels of cytokines and angiogenic factors     in IVF vs spontaneously conceived singleton pregnancies. The null hypothesis is that there     will be no significant difference.   "
228039|NCT00837291|"     This study will test the effectiveness of CF101 in treating the symptoms of osteoarthritis     (OA) of the knee. Eligible patients will be given either CF101 or matching placebo tablets     and their symptoms will be evaluated over the 12 week treatment period.   "
228040|NCT00837304|"     The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases     largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the     gold standard in the evaluation of the mucosa in patients with Ulcerative Colitis (UC).     PillCam Colon Capsule was developed by Given Imaging, Israel, as possible alternative imaging     modality to evaluate mucosal changes in patients with UC. The colonic mucosa can be     visualized and recorded by video while the colon capsule passes the colon.      Many patients suffering from UC ask their physician for possible alternative diagnostic     imaging because they are uncomfortable with conventional colonoscopy.      The primary aim of the present study is to compare the new Pillcam Colon Capsule with     standard colonoscopy with respect to assessing mucosal disease activity and localization of     inflamed colonic mucosa in patients with known UC.   "
228041|NCT00837317|"     The purpose of this study is to compare the effects of the consumption of different oils     (olive oil, sunflower oil, sunflower plus dimethyl-polysiloxane, sunflower plus phenols)     previously submitted to heating in postprandial endothelial function, inflammation and     oxidative stress in healthy young men.   "
228042|NCT00837330|"     This Phase I/II safety study is designed to investigate the safety and efficacy of     ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a     potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels     under the retina. These abnormal blood vessels can bleed or leak fluid, causing disruption of     normal retinal function and vision loss. Ranibizumab is a drug that is FDA-approved for the     treatment of wet age-related macular degeneration (AMD) and is injected directly into the     eye. Given the efficacy of ranibizumab in the treatment of wet AMD, and the postulated     similarity between the disease mechanisms involved in both wet AMD and PCV, we believe     ranibizumab will have a beneficial effect on visual function in patients with PCV.   "
228043|NCT00837343|"     Bipolar disorder (BD) is also named as a bipolar affective disorder, belonging to a kind of     severe mental disorder involving both mania or hypomania and depression episode, with     lifetime prevalence between 1.2 - 1.6%. The hygienic burden of bipolar disorder is high, and     its disease burden lies in top 10 position among the population of 15 - 44 years of old     patients and concomitant with relative high suicide rate (10 - 15%) and mutilation rate, as     reported by the World Health Organization (WHO) 2001 Annual Report. Drug treatment is one of     the main treatment methods for this kind of disease, and the dose selected will interfere the     efficacy and prognosis of the patient.      Quetiapine fumarate (Seroquel) is a dibenzothiazepine derivative, which is widely used in the     world. It has the indications in schizophrenia, bipolar mania and depression approved by FDA.     Quetiapine fumarate has been used in China for almost 10 years, which is in the treatment of     schizophrenia. The indication of bipolar mania has been approved by SFDA recently.     Exploration of the relationship between the dose and efficacy has been a hot spot in the     clinical practice as the drug has a broad action spectrum and wide dose range     (200mg/d－800mg/d).      Brain-derived neurotrophic factor (BDNF) plays an important role in the pathophysiology of     bipolar disorder. Some clinical studies indicate the blood BDNF level decreased during the     depression phase in the bipolar disorder, and the blood BDNF level is negative proportional     to the severity of the depression; and the same phenomenon was found, i.e. the blood BDNF     level decreased during the manic phase in the bipolar disorder, and the blood BDNF level is     negative proportional to the severity of the mania. Quetiapine fumarate was found to reduce     the decreasing of the expression of BDNF in the rat hippocampus and brain mantle in some     animal experiments, indicating quetiapine fumarate has the possibility on potential     interfering BDNF in the treatment. However, few study on comparison of the blood BDNF level     between pre and post treatment in the bipolar disorder was conducted.   "
228044|NCT00837356|"     This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two     recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®,     in haemophilia A subjects, investigating the action and safety of the drugs.   "
228087|NCT00837915|"     The objective of this study was to compare the single-dose relative bioavailability of     Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg     Extended-Release Tablets, in a fully replicated design, under fasting conditions.   "
228046|NCT00837382|"     Many service members returning from Iraq and Afghanistan have difficulties adjusting back to     civilian life. Research shows that symptoms of posttraumatic stress disorder (PTSD) are     particularly high in returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)     veterans, and that combat-related nightmares and sleep disturbances are common in veterans     with PTSD. This is of concern because people with these problems will often use unhealthy     ways of coping. Although combat-related nightmares and difficulty sleeping are highly     distressing, there are helpful treatments that do not involve taking medication. One of these     treatments teaches specific skills to help people improve their sleep habits and to change     their nightmares so that they are less upsetting. This treatment can be very helpful and     research shows that people experience decreases in the frequency and severity of their     nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and     quantity after completing treatment. However, because this treatment has only been studied     with civilians, it is not clear how well this treatment works for returning veterans. This     study tests how well this treatment works in treating combat nightmares in veterans who also     have PTSD from experiencing a traumatic event.   "
228048|NCT00837408|"     Objectives:        -  To conduct a genome-wide association study (GWAS) to identify susceptibility genetic          variants for diabetes among Han Chinese.        -  To conduct resequencing of positional candidate gene/loci to identify likely functional          variants in a subset of the cohort.        -  To conduct replication studies of the top-100 scoring variants in three independent          African and European ancestry samples.        -  To investigate whether diabetes-associated variants discovered in European populations          increase diabetes risk in Han Chinese.      Eligibility:        -  Patients 25 years of age with newly diagnosed T2D in Suizhou, China. Control subjects          are nondiabetics, age and ethnically matched to patients.      Design:        -  The study design for both patients and controls consists of the following steps:        -  Discuss informed consent process and obtain signed informed consent form. Informed          consent will be administered by trained clinic staff.        -  Assign study ID (barcode)        -  Administer questionnaires        -  Obtain spot urine sample        -  Measure blood pressure        -  Obtain anthropometric measurements including body composition        -  Perform finger prick for blood glucose level        -  Obtain venous blood samples        -  Perform eye examination        -  On the following day, perform confirmatory blood glucose for the small subset of          participants requiring confirmation of previous test result        -  DNA extraction of stored samples will be done at either the National Institutes of          Health or the laboratory in China.        -  GWAS will be conducted using publicly available software packages.   "
228049|NCT00837421|"     Specific Aim #1: To collect follow-up information about patients with sepsis in the OSUMC     MICU who survive to hospital discharge for future retrospective IRB-approved studies.      Specific Aim #2: To collect a registry of patients who would be interested in hearing more     information about future prospective IRB-approved studies for survivors of sepsis.      Specific Aim #3: To collect a blood sample from patients with sepsis admitted to the OSUMC     MICU for future retrospective IRB-approved studies.   "
228050|NCT00837434|"     Rheumatoid arthritis (RA) is a chronic disease that leads to inflammation and progressive     joint damage. RA is a systemic inflammatory autoimmune disorder affecting almost 1% of the     United States population. Current therapies target the immune system early in the disease     process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor     necrosis factor (TNF)-blocking agents. The primary purpose of this study is to determine the     effectiveness of two TNF inhibitors, etanercept and adalimumab, on memory B lymphocytes     (B-cells) in the peripheral blood of participants with RA.      Additionally, there are 4 optional sub-studies as part of the trial:        -  B-Cell Kinetic Sub-Study to look at changes in B-cell subsets over time and how quickly          reductions in B-cell memory occur        -  Vaccine Response Sub-Study to assess B cell memory in response to immunization with          hepatitis B,-hepatitis A, and diphtheria/tetanus vaccines, and to determine whether          T-cell vaccine responses are altered with TNF blockade        -  Tonsil Biopsy Sub-Study to evaluate how TNF blockade affects memory B-cells in the          tonsil dendritic cells and germinal cells        -  Synovial Biopsy Sub-Study to evaluate how TNF blockade affects changes in memory B-cells          in lymphoid tissue.   "
228051|NCT00837447|"     The purpose of this prospective, randomized study was to compare pain, functional outcome and     ranges of motion of the knees in patients receiving either a standard posterior     cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.   "
228052|NCT00837460|"     The purpose of the study is to analyse the prehensions deficits and the effect of prehension     rehabilitation in central nervous system lesioned people   "
228053|NCT00837473|"     The purpose of this study is to determine if Plexur P grows bone in the iliac crest (where     bone was removed or harvested) for the back surgery.      The study will be focusing on patients who require back surgery. Often additional bone is     required from the hip of the patient (iliac crest). When bone removed from the hip, a void     is often created. This void will be filled in with Osteotech's Plexur P product.   "
228088|NCT00837928|"     RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause     less damage to normal tissue.      PURPOSE: This phase I trial is studying the side effects and best dose of bendamustine when     given together with radiation therapy in treating patients with brain metastases caused by     solid tumors.   "
228089|NCT00837941|"     The purpose of this study is to determine if analgesic efficacy can be detected with single     dose administration in patients with chronic neuropathic pain due to painful diabetic     neuropathy.   "
228090|NCT00837954|"     The purpose of this trial is to demonstrate that the bleeding time of suture holes after     construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than     with Surgicel®   "
228054|NCT00837486|"     Medtronic, Inc. sponsored an investigational study of the Reclaim™ Deep Brain Stimulation     (DBS) System in people that have treatment-resistant depression. Depression is a mood     disorder and a serious medical condition that affects millions of Americans. Depressive     symptoms may include loss of interest in things typically enjoyed; decreased energy levels;     difficulty concentrating or making decisions; restlessness; and feelings of pessimism,     hopelessness, and worthlessness. Treatment-resistant depression is a chronic and severe form     of depression characterized by failure to respond to traditional forms of treatment, such as     antidepressant medications and electroconvulsive therapy. Treatment-resistant depression     significantly impacts quality of life, productivity, and is a major contributor of disability     world-wide.      This randomized, double-blind, sham stimulation-controlled, multi-center, prospective,     parallel design study used deep brain stimulation technology to test whether active bilateral     stimulation can safely and effectively improve depressive symptoms in patients with     treatment-resistant depression compared to sham stimulation.      Participants meeting criteria for the study were implanted with the Reclaim DBS System.     Participants in the active group, who received active stimulation, were compared to the     control group, who received sham stimulation, during the 16-week blinded-treatment phase. All     participants were monitored for changes in depressive symptoms. After the blinded-treatment     phase, all participants received active stimulation.      Candidates for the trial were adults who had major depressive disorder and had not responded     to several treatments for depression. Participants in the study continued to receive their     current antidepressant medications while participating in the trial.   "
228059|NCT00837551|"     WBI-1001 is a synthetic,new, non-steroid, small molecule being developed as a candidate drug     for the topical, cream treatment of inflammatory skin diseases. As such, it affects T-cells     through inhibition of T-cell activities including their infiltration processes, and it shows     direct anti-inflammatory manifestation in the mouse edema model. This was a 28 day study     (plus one follow-up week) on patients with Atopic Dermatitis, and 36 patients were treated     randomly, BID with either 0.5%, 1.0% or placebo. Blood samples were taken weekly for PK     analysis.   "
228060|NCT00837564|"     60 patients with chronic major depressive disorder according to DSM-IV will be included into     the study. Patients will be randomized to receive an open treatment either with CBASP, a     psychotherapy for chronic depression, or pharmacological treatment with Escitalopram for 28     weeks.   "
228061|NCT00837577|"     The phase III clinical trial examines the efficacy, safety, and tolerability of the addition     of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have     inadequate glycemic control on diet/exercise therapy and voglibose monotherapy   "
228062|NCT00837590|"     We intend to pursue the following Aims:        1. Does inflammation contribute importantly to concurrent defects in vascular and metabolic          dysfunction in human pre-diabetic obesity?        2. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in          the context of existing treatment with metformin?        3. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in          the context of existing treatment with lisinopril?      The intent of the current project is to efficiently and at low cost generate preliminary data     along each of these lines of questioning, studying the minimum number of subjects required to     assess the viability of the question using the current measurement approaches.   "
228063|NCT00837603|"     In transposition patients after atrial switch operation, the morphological right ventricle     serves as the systemic ventricle. These patients often develop signs of heart failure. It is     not known, whether physical training can safely be recommended in these patients- like heart     failure guidelines recommend training in patients with normal anatomy. Furthermore it is not     known, whether these TGA-patients benefit from training with respect to cardiopulmonary     exercise capacity.   "
228064|NCT00837616|"     Estrogen is necessary for feminization during puberty and to decrease bone resorption, the     latter critical for the achievement of peak bone mass and normal bone health in the female.     The practicing pediatric endocrinologist often faces the dilemma of how to best feminize     girls with hypogonadism (lack of estrogen), manifested as delayed or arrested puberty, due to     disorders of the brain or the ovaries. We propose a series of studies to address which type,     dose, and route of delivery of estrogen are suitable choices in feminizing and sustaining     estrogen concentrations in adolescent girls with Turner syndrome. To accomplish this we will     study girls/young woman between the ages of 13 to 20 with Turner Syndrome in 2 protocols. In     Protocol # 1 we will study 24 girls with TS, they will receive 3 different estrogen     preparations, either by mouth or via a patch for a total of 6 weeks. They will come to the     clinical research center for blood draws after 2 wks of taking the estrogen. With this study,     we hope to learn how the body responds to estrogen differently, depending on the form     estrogen is given and how high, estrogen levels gets in the blood in these girls with Turner     Syndrome. We will be comparing these patients estrogen levels to girls that menstruate     normally and do not have Turner Syndrome. In Protocol #2, 40 patients with TS will be     recruited; these patients will take estrogen for 1 year, either by mouth or via a patch.     Patients will come to the lab for blood drawn in 7 occasions and we will measure estrogen     levels as well as other hormones and lipid levels. We will also perform a Dual-energy X-ray     absorptiometry (DXA) study (like an X ray) to assess body composition and bone     mineralization. We will adjust doses based on the estrogen levels we find. With this study we     hope to learn how estrogen affects body composition, i.e., the amount of fat vs. muscle, and     how different forms of estrogen affect blood cholesterol and other hormones. This study will     allow us to understand better how to best replace young woman with Turner Syndrome with     estrogen.   "
228065|NCT00837629|"     This non-interventional study is to analyse the therapeutic effectiveness in patients with     severe COPD following a generally accepted 12-week treatment period with Symbicort     Turbuhaler, which could anyhow be shortened or extended at physician's discretion.   "
228136|NCT00832234|"     This is a Phase II multicenter study designed to evaluate the safety and efficacy of     combination BDR. BDR will be administered in one 21-day treatment cycle followed by four     35-day treatment cycles to patients with WM.   "
228066|NCT00837642|"     The prevalence of infertility has been estimated at 9% worldwide. The steadily increasing use     of assisted reproductive technologies (ART) has allowed millions of infertile couples to have     children. These children make up for 1 to 4% of the population in developed countries. ART     involves the manipulation of early embryos at a time when they may be particularly vulnerable     to external disturbances. In line with this concept, studies in mice suggest that ART alters     the activity of enzymes involved in the regulation of metabolic and cardiovascular     homeostasis. Alternatively, infertility itself or the drugs used to stimulate ovulation may     have adverse effects on the outcome of the offspring. The safety of ART for long-term health     is, therefore, of utmost importance. Among the potential long-term consequences of ART,     cardiovascular disease may represent an important candidate, but there is no information.      Preliminary data from our group show that, children born after in vitro fertilization (IVF)     present systemic and pulmonary vascular dysfunction at high-altitude when compared to age-     and sex-matched control subjects.      Therefore, the major goal of our proposal is to test the hypothesis that apparently healthy     children born after ART display vascular dysfunction of both the pulmonary and the systemic     circulation.   "
228067|NCT00837655|"     The purpose of this study is to perform a randomized, controlled clinical trial to     investigate if the phosphate binder sevelamer can improve insulin resistance and glucose     handling in patients receiving maintenance hemodialysis.   "
228068|NCT00837668|"     to determine the genetic pathways operating at the tissue level to cause granulomatous     inflammation in the lungs and lymph nodes of patients with sarcoidosis. By so doing, we hope     to identify unique genetic mechanisms which will aid in the diagnosis of sarcoidosis and will     help us understand the pathogenesis of this poorly understood disease.   "
228069|NCT00837681|"     The purpose of this study is to determine risk factors associated with the development of     lung disease after hematopoietic stem cell transplantation. Depending on the results and     findings of this study, it may be possible to predict who is at higher risk of serious     complications and ultimately develop therapies to prevent or treat this lung disease.   "
228157|NCT00832507|"     This Phase 2, randomized, double-blind, placebo-controlled, multicenter, dose-ranging study     will compare the efficacy, safety, and tolerability of cicletanine hydrochloride (HCl) to     placebo in subjects with PAH. Study drug will be administered alone, or on the background of     stable PAH therapy. The study will consist of 3 periods: a screening period, a 12-week     placebo-controlled treatment period, and a long-term, blinded extension period.   "
228070|NCT00837694|"     Food reinforcement, motivation to obtain food, is associated with energy intake and obesity.     Finding ways to decrease the reinforcing value of unhealthy foods may help with adherence to     diets and weight loss. Our previous study in non-obese adults showed that daily consumption     of the same snack food (food typically consumed outside of meals) for 14 days significantly     decreased its reinforcing value. The purpose of this study was to replicate and extend these     findings to obese individuals as well as to examine effects of different portion sizes of     snack foods on food reinforcement. Thirty-one obese (body mass index > 30 kg/m2) and 27     non-obese (BMI < 30 kg/m2) women had food reinforcement and liking tested at baseline and     after two weeks of daily consumption of either 0 kcal, 100 kcals, or 300 kcals daily of the     same snack food.   "
228071|NCT00837707|"     The aim of the present study was to investigate the efficacy of aripiprazole in management of     pre-existing neuroleptic-induced tardive dyskinesia   "
228072|NCT00837720|"     This open label, non-interventional study is to show the efficacy of antihypertensive     treatment with Atacand in hypertensive patients. Efficacy is to be evaluated based on the     difference in systolic and diastolic blood pressure at baseline and at both follow-up visits.   "
228073|NCT00837733|"     The purpose of this study is to evaluate the influence of endometrial biopsy on increasing     implantation rate in patients with recurrent implantation failures, 93 women with at least     two implantation failures were evaluated. In case group endometrial biopsy was obtained from     48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy     rate were compared with 45 patients in control group. The results suggest that in vitro     fertilization or intracytoplasmic sperm injection after endometrial biopsy increase pregnancy     outcome.   "
228074|NCT00837746|"     This study analysed and reported on the study data from three similar, risedronate studies,     1996052, 2003073, and 2003096. The objective of the study was to determine the differences in     the iliac crest bone histomorphometry and bone quality in postmenopausal women who had     received long term therapy with risedronate.   "
228075|NCT00837759|"     Background:        -  Type 1 diabetes (T1D) occurs when the immune system attacks insulin-producing cells          (beta cells) in the pancreas, resulting in their death.        -  Insulin injections currently are the best method for controlling blood sugar in          individuals with T1D. However, animal studies have shown that the drugs sitagliptin and          lansoprazole can help reverse beta cell damage or develop new beta cells. In addition,          Diamyd has been shown to weaken the immune process that attacks pancreatic beta cells.      Objectives:        -  To find out whether a combination treatment of sitagliptin, lansoprazole, and Diamyd          will help maintain functioning beta cells and/or cause new beta cells to form.        -  To determine how the drug combination affects insulin doses and blood sugar control.        -  To determine whether the drug combination affects the immune response involved in T1D.   "
228076|NCT00837772|"     Patients are referred to the VA orthopedic surgical clinic because of osteoarthritis and are     requesting consideration for a total knee replacement. Those who qualify for the knee     replacement are informed about the study. Those who consent to participate are randomly     assigned to either the standard cutting guide or to the new method which is a MRI generated     cutting guide called Otismed. All patients have an MRI so both groups will be unaware of     which surgical technique is used. All patients receive the usual pre-op care and same type of     replacement knee. Follow-up research visits are scheduled at 4 weeks, 3 and 6 months, and 1     and 2 years. Patients will be informed of which surgical technique they were randomized to at     the conclusion of the study.   "
228077|NCT00837785|"     To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary     metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with     relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic     characteristics.   "
228078|NCT00837798|"     The purpose of this registry is to produce a prospective, outcome-oriented registry to     document the prevalence of AT/AF in the CRM population by using the Advanced AT/AF     Diagnostics in select SJM devices.   "
228079|NCT00837811|"     To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections     for 48 weeks in patients with Rheumatoid Arthritis   "
228092|NCT00837980|"     The purpose of the study is to generate a library of functional imaging and anatomical     imaging for patients with head and neck cancers for evaluation of new radiotherapy strategies     and planning techniques including IMRT. Secondary aims would be to observe the changes in the     cancers as the treatment progresses as well as to define the biologically most active part of     the tumor (biological target volume) which could be given more intensive treatment. Tumor     volumes seen on different imaging modalities will be compared with a hope of finding an     optimal imaging methodology for accurate visualization of the head and neck cancers   "
228093|NCT00837993|"     Primary Objective:        -  To reclassify the histologic grade of the serous ovarian cancer specimens of patients          enrolled on Gynecologic Oncology Group (GOG) protocol 158 using a two-tier system.      Secondary Objective:        -  To determine the overall and progression-free survival of patients with serous carcinoma          of the ovary treated on GOG protocol 158 when reclassified according to tumor grade (low          vs. high).      Tertiary Objective:        -  To correlate histologic grade with other prognostic factors.   "
228094|NCT00838006|"     The primary objectives of this proposal are to develop objective pre-deployment predictors of     PTSD and test two pre-deployment resiliency interventions.   "
228095|NCT00838019|"     The purpose of this study is to evaluate the viability of intrabone administration of     umbilical cord blood as allogenic transplantation for the treatment of hematologic     malignancies.   "
228110|NCT00838214|"     This is a multicentre, multinational clinical study. It comprised two consecutive segments (A     and B). Segment A was designed as a randomized, double-blind, double-dummy,     active-controlled, two-arm parallel-group study. The patients received either budesonide or     prednisone for 6 months. During segment B all patients received budesonide as an open     treatment for additional 6 months.      In this confirmatory study the proportion of patients with complete response was compared     between the two treatment groups. Complete response was defined as biochemical remission     (=serum levels of ASAT and ALAT within normal ranges) at the individual last visit of segment     A and lack of steroid specific side effects throughout segment A.   "
228096|NCT00838032|"     Quetiapine fumarate is indicated for the treatment of patients with schizophrenia in China.     Lots of clinical experience and evidence has demonstrated its efficacy and tolerability for     the patient population. Some evidence showed that quetiapine fumarate could control     aggression and agitation within 1 week, which is appropriate for the acute treatment of     patients with schizophrenia. PANSS and MOAS are the common measurements for the efficacy of     psychotic symptoms controlling in the clinical trials. Generally, 2 weeks are the appropriate     timeframe for the evaluation of clinical effect of agitation and aggression symptoms     controlling.      In adult patients with schizophrenia, quetiapine fumarate is licensed to maximal dose of     750mg/day. The target dose of quetiapine fumarate recommended in the manufacturer's     prescribing information is 300-450 mg/day in China, though similar efficacy for quetiapine     fumarate (600 mg/day), olanzapine (15 mg/day) and Risperidone (5 mg/day) was reported in a     small, randomised, rater-blinded trial. Because of the low incidence of EPS, the limitation     potential for weight gain and prolactin elevation, quetiapine fumarate should be well     tolerated in this sensitive patient population with higher dose (600mg/day-750mg/day)     (Peuskens 2004).      The aim of the present study is to evaluate the efficacy and safety of quetiapine fumarate     with daily dose 600-750mg/day in improving agitation and aggression for the treatment of     Chinese acute schizophrenic patients hospitalised for acute phase over a treatment period of     2 weeks   "
228097|NCT00838045|"     This study is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos TL (thin     lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.   "
228098|NCT00838058|"     The study will try, in 2 separate parts, each using 12 research subjects, to see how a new     form of the pill CE 224,535 gets released into the bloodstream and whether that is affected     by food. In each part, subjects will switch among 4 treatment periods to take either     different forms of the pill(s) or the same form either after fasting or eating a meal. The     second part will only happen depending on whether the sponsor believes it is needed and will     use separate subject than the first part.   "
228099|NCT00838071|"     The purpose of this study is to determine whether protective anti-HB serum levels are     maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific     hepatitis B immune globulin, in patients having previously undergone liver transplantation.   "
228100|NCT00838084|"     This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of     LY2811376 single doses, how the body handles the drug, and the drug's effect on the body.   "
228101|NCT00838097|"     This European study observes paediatric patients with Chronic Kidney Disease using     Darbepoetin Alfa to assess the drug's long term safety and profile the patterns of its use     within this population.   "
228102|NCT00838110|"     This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in     2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon     20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with     Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the     study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label     extension study.   "
228103|NCT00838123|"     The aim of this research is to explore which cognitive function would affect the job tenure     among people with schizophrenia. The investigators plan to recruit 60 people diagnosed with     schizophrenia and divide into two groups, employment and unemployment. The investigators will     use several cognitive function tests to collect their cognitive functions and PANSS to     evaluate their psychotic symptoms. And then the investigators will compare and analysis the     data through statistic software. Finally, the investigators will have the answer about if     cognitive functions would affect the job tenure among people with schizophrenia. And the     investigators hope that we could get the predict factor of cognitive function to predict the     successful employment in future.   "
228104|NCT00838136|"     The objective of this study is to compare the rate and extent of absorption of lamotrigine 25     mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg     chewable dispersible tablets under fed conditions.   "
228105|NCT00838149|"     The purpose of this study is to see whether enteral glutamine supplementation improves     intestinal permeability and small intestinal morphology in patients with Crohn's disease.   "
228106|NCT00838162|"     The purpose of this study is to evaluate the antiviral activity as measured by the change in     viral load from baseline in the 14 days following initiation of treatment with 4 different     dose regimens of TMC310911 co-administered with ritonavir.   "
228107|NCT00838175|"     Suture-mediated closure devices are effective and safe for achieving rapid hemostasis in     femoral venous access site and reducing the incidence of complications associated with     traditional closure methods. Furthermore, there are predictive factors(such as sheath size,     obesity, procedure duration, and anticoagulation status)that we can use to assess the     procedure's likelihood of success in various patients.   "
228108|NCT00838188|"     OBJECTIVE. Neonatologists consider early feeding at the breast to be too tiring for preterm     infants, although there is no evidence that this is actually the case. It is also not known     whether the method of feeding affects energy expenditure. We hypothesized that resting energy     expenditure (REE) would be higher after breastfeeding than after bottle feeding.      PATIENTS AND METHODS. preterm ( >32 weeks GA) stable infants who are nourished entirely by     their mothers' breast milk will be studied when fed expressed breast milk either by bottle or     at the breast. REE will be measured for 20 minutes after feeding. Breast milk quantity is     evaluated by pre- and post feeding weighing.   "
228109|NCT00838201|"     The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3     years under the 20040138 Amgen study and 2 years on this study) denosumab administration as     measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who     previously received denosumab for non-metastatic prostate cancer.   "
228111|NCT00838227|"     This is an open label 8-week trial of modafinil up to 400 mg daily added to a stable     antipsychotic regimen to evaluate the effect modafinil on cognition, sedation, and weight in     patients with chronic schizophrenia. We hypothesize that modafinil, a wake-promoting agent,     will lead to improved cognition, increased wakefulness, and decreased weight in patients with     schizophrenia who are on stable antipsychotic regimens   "
228112|NCT00838240|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine, cytarabine, and idarubicin, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more cancer cells.      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of     clofarabine and to see how well it works when given together with cytarabine and idarubicin     in treating patients with intermediate-risk or high-risk acute myeloid leukemia or high-risk     myelodysplasia.   "
228113|NCT00838253|"     The purpose of this study is to assess the safety and efficacy of istaroxime in patients     hospitalized for Acute Decompensated Heart Failure (ADHF) not requiring inotropic     therapy.This will be done by comparing the hemodynamic effect of a 24-hour infusion of three     different doses of the drug versus placebo. Efficacy will be measured as a change in     Pulmonary Capillary Wedge Pressure from pre-infusion to 6 hours after infusion start.     Secondary objectives will include the evaluation of clinical efficacy and safety through     assessment of cardiovascular and renal tolerability as well as changes in biological markers     such as brain natriuretic peptide (BNP) and troponin I (TNI), and the neurohormones renin and     aldosterone and also to assess the pharmacokinetics of istaroxime and its metabolites.   "
228114|NCT00838266|"     The objective of this study is to evaluate the efficiency of a new mouthrinse on dental     plaque deposits.      The study is carried out on 50 volunteers that are asked to use the mouthrinse without any     other oral hygiene measure, during 4 days. It is a double bind, cross-over, randomized     design: the same subjects test the active product and the placebo.   "
228115|NCT00838279|"     The objective of this study is to compare the rate and extent of absorption of lamotrigine 25     mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg     chewable dispersible tablets under fasting conditions.   "
228116|NCT00838292|"     The purpose of the study is to test whether food supplementation of malnourished HIV-infected     adults (both pre-ART and ART) in resource constrained settings improves their nutritional     status, clinical status, effectiveness of treatment, quality of life, functioning, and     survival.   "
228117|NCT00838305|"     The purpose of this study is to measure the effects of MDMA (particularly its emotional     effects) and to determine the role of serotonin in these effects. Serotonin is a     neurotransmitter, which is a chemical that is released by some brain cells to communicate     with other brain cells. Many of the effects of MDMA are thought to be the result of increased     serotonin release.      In order to understand the effects of MDMA and role of serotonin in these effects, we will     administer MDMA alone and in combination with the antidepressant citalopram (one trade name     for this is Celexa). Citalopram decreases the ability of MDMA to release serotonin.     Citalopram will therefore decrease any of MDMA's effects that are the result of serotonin     release; we want to measure this.   "
228118|NCT00831987|"     To observe and to describe the safety during Days 0 to 21 following injection of the     2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects     aged 18-59 years and subjects aged ≥ 60 years.      To measure and to describe the immune response (antibodies to hemagglutinin) 21 days     following injection of the 2004-2005 formulation of the inactivated, split-virion influenza     vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.   "
228119|NCT00832000|"     Nondystrophic myotonias (NDM) are neuromuscular disorders caused by genetic abnormalities in     certain muscle cell membrane proteins. The proteins affect muscle contraction. Individuals     with NDM experience limited muscle relaxation, which then can cause pain, weakness,     incoordination, and impaired physical activity and function. Because NDM is very rare,     information on the best way to treat people with the disorders is lacking, and there are no     FDA-approved therapies. The purpose of this study is to determine the effectiveness of the     medication mexiletine in treating people with NDM.   "
228151|NCT00832429|"     The goal of this clinical research study is to use sentinel lymph node (SLN - the lymph nodes     closest to the primary tumor that are believed to be at greatest risk for spread of the     disease) mapping to find SLNs and biopsy them to see if you have metastatic disease (cancer     that has spread) that would otherwise have not been found.   "
228755|NCT00842244|"     The purpose of this study is to determine the safe and tolerable dose of axitinib given     together with cisplatin and capecitabine in patients with advanced gastric cancer who have     not received prior chemotherapy for their advanced cancer.   "
228120|NCT00832013|"     Advances in health care require that more children are given sedation to allow doctors to     perform investigations or minor procedures. Sedation drugs have traditionally been given     orally (swallowed) by children. However, oral sedation drugs have unpredictable     characteristics, such as duration of sedation, which may result in difficulties performing     the planned procedure.      Anesthetic drugs are now invariably used for sedation in children. These are given through an     IV (skinny plastic tube inserted in to a vein). Propofol (white liquid) is the anesthetic     drug most commonly used for sedation at BC Children's Hospital for sedation. Propofol has     several advantages, including an accurately controllable depth of sedation (how deeply     asleep), minimal effect on the heart and circulation and control of reflexes (e,g coughing)     during the procedure. Propofol also promotes rapid recovery with less sickness and an earlier     return to normal functioning following the procedure.      While propofol has many advantages it can cause respiratory depression (reduced breathing     rate). This reduction in breathing is more common if propofol is given quickly. When your     child is given propofol for their proposed procedure this is performed by a pediatric     anesthesiologist who is skilled in supporting breathing should this be required. If your     child does not participate in this study they will still receive propofol administered by the     anesthesiologist as this is our usual practice. It would be routine to administer the     propofol rapidly and then support breathing for a few minutes. This is very safe in the hands     of an expert anesthesiologist but can be sometimes more risky in other settings where     extensive monitoring and anesthesiologists are not available. This is the setting that     propofol is used in many institutions.      Our goal is to determine how quickly propofol can be given without reducing breathing to the     point that help with breathing is required.   "
228139|NCT00832273|"     VTI had established other clinical protocols to study the effects of ELAD® plus standard     therapy compared with standard therapy alone in patients with acute on chronic (AOCH)     (VTI-201, VTI-206) and fulminant hepatic failure (FHF) (VTI-202) and acute alcoholic     hepatitis (AAH). However, liver failure (LF) patients who do not qualify for other protocols     may benefit from ELAD use. In order to accommodate physician requests for the use of ELAD in     LF patients who do not qualify for open Protocols, without the need to resort to individual     Emergency Use INDs for each case, VTI has developed a Treatment Protocol with Cost Recovery     to provide for expanded access to ELAD for those with LF. This uncontrolled Treatment     Protocol has been designed to provide expanded access to ELAD in subjects with LF while     assuring that sufficient data are collected to adequately monitor ELAD safety when used in     this setting at multiple centers in the United States.   "
228121|NCT00832026|"     This research is being done to examine if a nasal cannula can be used to keep the throat open     during sleep, thereby treating sleep apnea.      People with sleep apnea and people who snore without sleep apnea may take part in this study.     Sleep apnea is a disorder caused by pauses in breathing due to repetitive closure of the     throat. The most common form of treatment for sleep apnea is continuous positive airway     pressure (CPAP) therapy. While CPAP therapy remains the simplest and most effective treatment     for snoring and sleep apnea, patients have to wear a nasal mask throughout the night. For     this reason, patients often have difficulty sticking to therapy.      Participants enrolled in this study will spend 3-nights in a sleep laboratory. In all nights,     the investigators will monitor your sleep and your breathing throughout the night. The     investigators will apply several electrodes (sensors) to your scalp and face to monitor your     sleep and breathing, and other sensors to your chest, abdomen, cheek, and a finger to monitor     your breathing and oxygen level.   "
228122|NCT00832039|"     Severe sepsis and septic shock are diseases of infectious origin with a high risk of death.     The purpose of this study is to determine whether the intravenous application of selenium     (given as sodium-selenite) can reduce mortality in patients with severe sepsis or septic     shock. Additionally, it is investigated, whether the measurement of procalcitonin - a marker     of infection - can be used to guide anti-infectious measures in this disease.   "
228123|NCT00832052|"     Evaluate the safety and tolerability of PF-04447943 after administration of multiple doses in     healthy elderly participants. Evaluate plasma drug levels and effects on cognition.   "
228124|NCT00832065|"     Obstructive Sleep Apnea Syndrome (OSAS)is a common disease and is suspected to be associated     with sexual dysfunction. Our purpose is to sudy the effect of CPAP (Continuous Positive     Airway Pressure) treatment on patients' sexual dysfunction by measuring testosterone levels     before and after CPAP treatments.   "
228125|NCT00832078|"     The purpose of this study is to evaluate the safety of an intermittent catheter in comparison     with an already existing catheter on the market. The study is a randomised, single blinded,     cross-over study including 25 healthy males.   "
228126|NCT00832091|"     The purpose of this study is to evaluate the safety, tolerability and effectiveness of     Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers   "
228127|NCT00832117|"     The purpose of this study is to determine the highest dose of ixabepilone that can be given     safely with cisplatin without causing severe or life-threatening side effects and for some     patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also     be studied   "
228128|NCT00832130|"     The objective of this study is to evaluate the clinical utility, safety and effectiveness of     the Manual Mini System compared to standardized warm compress therapy for application of     controlled, localized heat therapy in adult patients with chronic cystic conditions of the     eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid     deficiency dry eye, and chalazia.   "
228129|NCT00832143|"     Neonatal mortality rate in Uttar Pradesh, Northern India is 53.6 per thousand, and accounts     for 8% of global neonatal deaths.It has been argued that prompt and appropriate care-seeking     for sick neonates can substantially reduce neonatal mortality. This pre and post intervention     trial was done to assess the impact of a pictorial Neonatal referral Card and one-to-one     counseling of mothers on the qualified medical care-seeking behavior for sick neonates in     urban Lucknow.      The study hypothesis was that the counseling on danger signs along with neonatal referral     card has no impact on availing services of a qualified medical practitioner by caregivers of     sick neonates.   "
228130|NCT00832156|"     In this study the treatment of full thickness burn wounds with cultured autologous     keratinocytes in combination with meshed split skin autograft versus meshed split skin graft     alone will be compared. It is expected that the application of cultured autologous     keratinocytes in combination with a meshed split skin autograft will improve wound healing     and scar formation.   "
228131|NCT00832169|"     The aim of this study is to get information about absorption, distribution, metabolism and     excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.   "
228132|NCT00832182|"     This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate     the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to     the ANA/DCD/065 trial   "
228133|NCT00832195|"     The purpose of this study is to assess whether shoes that are more controlling for movement     of the foot and ankle, compared to shoes that are less controlling, will reduce the overall     number and severity of injuries experienced during a 13-week running programme. Our     hypothesis is that runners who wear more controlling footwear during the 13-week programme     will experience less injury events.   "
228134|NCT00832208|"     This is a phase II/III open, comparative dose trial to find the lowest single dose of     AmBisome for the treatment of primary, symptomatic visceral leishmaniasis(VL), in HIV     negative patients. In this trial, the minimum effective dose will be determined in a     sequential step, dose escalation design, which minimises the number of patients exposed to     low, potentially inadequate doses and provides contemporaneous comparative data against the     manufacturer's recommended dose schedule in this indication.   "
228137|NCT00832247|"     This is a phase I clinical study to evaluate feasibility, safety and kinetics of cellular     therapy with autologous bone marrow-derived mononuclear cells (BMMC) in patients with liver     cirrhosis due to virus C hepatitis. Another aim is to study liver tissue changes induced by     the BMMC presence. All the patients have moderate liver disfunction and will be submitted to     a liver biopsy before BMMC injection. The cells will be labeled with 99mTc and infused     through a peripheral vein. Scintigraphy will be performed 24 hours after infusion.      Patients will be submitted to frequent clinical, laboratorial and image evaluation during a     one-year follow-up. A second liver biopsy will be done in the 3rd month after infusion to     check histological, cellular and molecular evolutive changes.   "
228138|NCT00832260|"     The purpose of this observational study is to collect data regarding the population of     patients with a pacemaker implanted.   "
228156|NCT00832494|"     This study was designed to test the addition of DMXAA (now known as ASA404) to carboplatin     and paclitaxel in patients with NSCLC.   "
245065|NCT01068639|"     This study is conducted in Europe. This observational study aims at evaluating compliance     with growth hormone treatment in children and identifying factors influencing compliance.   "
228140|NCT00832286|"     The purpose of this study is to identify the human intestinal microbiota (microbes that live     inside and on human bodies) in healthy adults over a 6-month period and to study the effect     of an antibiotic on the intestinal microbiota. Participants will include up to 60 healthy     adult subjects, ages 18-45 years, from the Baltimore and University of Maryland communities.     Study procedures will include providing multiple stool samples throughout the study.     Participants will take a licensed antibiotic, Ciprofloxacin, for 3 days. Participants may be     involved in study related procedures for up to 7 months.   "
228141|NCT00832299|"     A Phase II open- labeled, prospective study to determine the efficacy of pre-operative     chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME)     followed by an additional six cycles of FOLFOX 6.      The objectives of this study are the following:        1. The primary endpoint of this trial is pathologic complete response (response rate).        2. Secondary endpoints will include observation of overall pathologic response rate,          correlation of pathologic staging with pre-operative ultrasound and pelvic MRI staging,          as well as observation of toxic side effects, patterns of disease relapse, disease-free          survival outcomes and overall survival outcomes.   "
228142|NCT00832312|"     The purpose of this study is to determine whether an intraarticular injection of Ozone into     the knee joint is an effective therapy for pain control in patients with osteoarthritis of     the knee.   "
228143|NCT00832325|"     The purpose of this study is to better understand how the illness has affected the identity     and what needs the survivor may have. We hope that this information will help us provide     better care to future adolescent and young adult cancer survivors.   "
228144|NCT00832338|"     The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your     breast tumor and allow you to preserve your breast or have less extensive surgery on your     breast. Additionally, by receiving chemotherapy before surgery, the investigators will be     able to determine if your cancer is responsive to chemotherapy.   "
228145|NCT00832351|"     Treatment in stroke units compared with treatment in general medical wards reduces the odds     of being dead or disabled. Little is known about which components of acute stroke care that     is responsible for this benefit.      Early mobilisation is one of the features of stroke unit care. In Scandinavia, any     intervention aimed to reduce the time to the first out of bed episode has been focused in     order to prevent complications.      However, therapeutic interventions for cerebral revascularisation and a more intensive unit     approach for observation may postpone mobilisation. The aim of the present study is to     identify whether early mobilisation (< 24 hours after admittance to hospital)reduce     disability and mortality compared with mobilisation after 24 hours.      The study is a prospective, randomised controlled study with blinded assessment at the end of     follow up. Patients admitted to the Stroke Unit, Akershus University Hospital less than 24     hours after stroke during 2009 - 2011 are screened for recruitment. Patients are randomly     assigned to either mobilisation out of bed within 24 hours from admittance to hospital or     mobilisation after 24 hours. Except early contra late mobilisation all patients receive     standard stroke unit care.      Patients with modified Rankin Scale 0 and 1, patients with a secondary intracerebral     hemorrhage, patients receiving thrombolysis or patients requiring palliative care are     excluded.      All patients are assessed at admittance, discharge and 3 months poststroke. Investigations at     admittance include standard blood sample, CT/MRI scan, EKG and ultrasound of carotid     arteries.      Main outcome is mortality and disability 3 months poststroke. Secondary outcome measures are     neurological deficits (NIH), morbidity, complications, cognitive function reflected by Mini     Mental State Examination and emotional function (Hospital Anxiety and Depression scale) .      Results from this study may add important knowledge about how and when to start mobilisation     of patients with acute stroke.   "
228146|NCT00832364|"     The purpose of the study is to assess the safety and efficacy of an injectable biologic and     U0279 as combination therapy compared to that of an injectable biologic alone for severe     plaque-type psoriasis.   "
228147|NCT00832377|"     A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination     eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug     administration   "
228148|NCT00832390|"     After 24 weeks of treatment evaluate the efficacy and security.   "
228149|NCT00832403|"     This is a retrospective study, involving patients with atrophic rhinitis, that underwent Gore     tex® implants in the nasal fossa.      The Fetid Rhinitis or Atrophic Ozena is a chronic illness characterized by yellowish     secretion in the initial phase and the other phases with fetid crusts and atrophy of the     mucous bone covering. Diverse theories exist that try to explain the appearance of this     pathology, such as: hereditary factors, immunological alterations, viral infection and     nutritional lack. Currently, its etiology remains unknown. As there isn't any ideal treatment     already established, this technique improves the options of treatment.      All patients have improved after the procedure.   "
228150|NCT00832416|"     The purpose of this study is to compare the analgesic efficacy and safety of Tramadol Once a     Day 100, 200, 300 mg and Placebo   "
228265|NCT00843934|"     The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and     epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular     Carcinoma (HCC).   "
228152|NCT00832442|"     Several large trials have shown that beta-blocker treatment reduces the risk of death and     hospital admission in patients with symptomatic heart failure. Unfortunately, survey data     suggests relatively poor utilisation of beta-blockers, despite ample evidence for good     tolerability. Additionally there are several important unanswered questions, such as clinical     efficacy for specific sub-populations (women, the elderly and patients with diabetes or other     co-morbidities) and the effect of beta-blockers in combination with other medications.     Previous meta-analyses, based on published tabular data, have been conducted although this     approach has important biases and limitations.      We plan to perform a carefully conducted systematic review of individual patient data from     the major randomised trials of beta-blockers in heart failure. The goals of this     collaborative project are to clarify the overall efficacy of beta-blockers and identify     sub-groups that show particular benefit, thereby increasing the use of beta-blockers,     reducing adverse clinical outcomes and the high costs associated with this condition.   "
228153|NCT00832455|"     a study to describe patient and physician satisfaction with montelukast therapy for the     control of asthma used either as monotherapy or in combination with inhaled corticosteroids   "
228154|NCT00832468|"     Ear acupressure is commonly applied to treat insomnia in Oriental clinical practice but     lacking the evidence of the randomized controlled trial (RCT)of ear acupressure on insomnia.     In this study, a RCT is conducted to investigate the complementary effect of ear acupressure     on chronic insomnia in old adults.   "
228155|NCT00832481|"     This is a 17 week, randomized, single center, open-label, parallel-group study to compare     glucose excursions and other efficacy and safety parameters of repaglinide thrice daily or     metformin thrice daily in newly diagnosed type 2 diabetes subjects in China.   "
228158|NCT00832520|"     The purpose of this study is to find out if remeron, also called mirtazapine, can help you     prevent weight loss while on treatment for your cancer. Remeron is currently used to treat     depression and has not been approved by the Food and Drug Administration for use to treat     weight loss.   "
228159|NCT00832533|"     1.1 To detect reproducible variations of serum 25-hydroxyvitamin D levels throughout the     course of one year in relationship to objectively measured levels of ultraviolet exposure.      1.2 To determine specific times within the year that would yield the most significant data     that could be focused on in future, larger studies examining whether there are protective     effects of serum vitamin D on the development of cutaneous melanoma   "
228160|NCT00832546|"     The purpose of this study is to determine the effects of NGX426 on intradermal capsaicin     induced pain in hyperalgesia.   "
228161|NCT00832559|"     This study is designed to assess the safety and initial indications of efficacy resulting     from multiple doses of CAVATAK injected directly into solid tumours of the Head and Neck that     have been confirmed to express ICAM-1 and DAF.      CAVATAK (Coxsackievirus A21) is a naturally occurring common cold virus that preclinical     research indicates can preferentially infect and kill cancer cells expressing the receptors     ICAM-1 and/or DAF. This virus is known to cause self limiting upper respiratory infections     and has been used previously to challenge therapies against the common cold. The virus is not     generically modified.      The study proposes to administer CAVATAK to three cohorts each of three patients. The first     cohort will receive a single dose, the second cohort will receive three doses, and the final     cohort will receive six doses. There will a 48 hour interval between repeated doses.      The primary objective of the study is to determine the safety and efficacy of CVA21 given by     intratumoural injection in the treatment of recurrent, unresectable squamous cell carcinoma     of the head and neck by measuring primary and field tumour status and adverse effects.      Secondary objectives of the study are:        1. Indirect measurements of efficacy by measuring appropriate biomarkers in serum and          tumour biopsy samples for viral replication, induction of apoptosis and anti-tumour          immune responses.        2. To determine the time course of potential primary and secondary viraemia.        3. To characterise the time course of the anti-CVA21 antibody response after administration          of CVA21   "
228162|NCT00832572|"     This study was to determine whether ranolazine was effective in the treatment of neuropathic     pain in patients with coronary artery disease.      Eligibility required neurological examination by the study doctor and assessment of the     patient's pain. Eligible participants were randomized to receive blinded study medication for     a total of 12 weeks.   "
228163|NCT00832585|"     This study will assess the safety, tolerability, and efficacy of Alefacept in patient with     moderate to severe atopic dermatitis who could not be adequately controlled with topical     therapies.   "
228164|NCT00832598|"     The purpose of this study is to help us understand gliomas, one type of brain tumor. This     research protocol makes pictures of gliomas. We will take pictures of the glioma before and     after treatment. The pictures are made with a positron emission tomography (PET) scanner. PET     scans use radioactive markers to see cancer cells. We plan to use two different radioactive     markers, [18F]FACBC and [18F]FLT, to see if the glioma responds to the treatment being     recommended by the doctor. We are investigating whether one or both of these types of PET     scans can help us to better understand gliomas and their response to treatment.      We expect these pictures will give us information the your tumor and may help us to     understand why the treatment that the patient is receiving is affecting the tumor the way     that it is. We also hope to collect information about the amount of radioactivity exposure.     We will measure radioactivity exposure to the tumor, brain and other organs.   "
228165|NCT00832611|"     To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of     life) in patients with COPD.   "
228166|NCT00832624|"     to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the     safety and tolerability of Sitagliptin.   "
228167|NCT00832637|"     This is a single arm phase II trial of Gemcitabine and Oxaliplatin (Gem-Ox) with Erlotinib     (Tarceva) for the treatment of hepatocellular carcinoma (HCC) and biliary tree cancer (BTC)     patients with platelet counts 100,000/µL. The purpose of this study is to determine the tumor     control rate following treatment with GEM-OX combined with Tarceva in patients with HCC.     Tumor control rate is defined as the percentage of patients achieving a complete response,     partial response, or stable disease at 24 weeks following treatment.   "
228168|NCT00832650|"     To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic     transit.   "
228169|NCT00838318|"     Primary Objectives:        1. To evaluate knowledge, beliefs, attitudes and values that influence perceptions and          utilization of colorectal cancer screening (CRCS) among first-degree relatives of          Hispanic CRC patients.        2. To assess factors influencing Hispanic CRC patients' communication of CRC risk and          screening information to their FDRs.      Secondary Objective:      1) To establish the feasibility of recruiting Hispanic CRC patients and their FDRs from the     institutional patient database and/or MDACC clinics.   "
228185|NCT00838526|"     The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 50     mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing     in subjects with healed erosive gastroesophageal reflux disease (eGERD).   "
228186|NCT00838539|"     The primary purpose of this study is to identify the maximum tolerated dose(s) of neratinib     in combination with temsirolimus in subjects with solid tumors. This study will also include     a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK) parameters of     the combination.   "
228187|NCT00838552|"     The study compares the biochemical markers in bronchoalveolar lavage samples from asthmatic     children to those markers found in non-asthmatic children with other respiratory diseases.     The investigators hypothesize that certain markers will be associated specifically with     asthma.   "
228188|NCT00838565|"     This study will evaluate the safety and tolerability of PF-04236921 administered monthly as     three intravenous infusions. Each group of patients will be assigned to a dose level; Safety     and tolerability of a low dose level will be required before proceeding to successively     higher dose levels. Blood tests will be performed to measure the amount of drug and changes     in measures of inflammation.   "
228170|NCT00838331|"     Transfusion of red blood cells is often used in critically ill patients with low red blood     cell counts to prevent disease progression and death. Recent studies suggest that the use of     aged versus fresh red blood cells are associated with worse clinical outcomes. There is     evidence that red blood cells work with the cells lining our blood vessels to produce a     variety of substances that normally cause arteries to relax and increase blood supply. Two of     these substances are called nitric oxide (NO) and endothelium-derived hyperpolarizing factor     (EDHF). The investigators are trying to determine the nature of these substances in human     beings when they are transfused aged versus fresh red blood cells. It is their thought     that aged red blood cells have less of the substances (NO and EDHF) that naturally relax     our arteries and further changes the blood supply. One way to determine this is to transfuse     a subject's own aged and fresh red blood cells and inject substances such as L-NMMA (L-NG     monomethyl arginine) and TEA (tetraethylammonium chloride), which block the production of NO     and EDHF respectively, and then, study what happens to the blood flow.      There is evidence that red blood cells produce NO, which normally causes arteries to relax     and increase blood supply. The investigators will try to determine the nature of NO in red     blood cells and whether the amount of this substance is altered because of different blood     processing and storage techniques. It is their thought that aged red blood cells have less     NO that naturally relaxes our arteries and further changes the blood supply. This study is     designed to determine the most ideal way of storing and processing blood.   "
228171|NCT00838344|"     In this study, the investigators will evaluate the impact of a Medication Adherence Program     (MAP), a systematic telephone call to patients who are overdue for refills, to assess     individual reasons or barriers to refilling prescribed DM medicines, discuss diabetes care     progress, and provide intervention to resolve any barriers to taking prescribed medicines.     The hypothesis for the study is that personalized telephone follow-up by a pharmacist will     assist people who have missed refilling their prescriptions in taking diabetes medicines by     resolving medication adherence challenges. Following randomization, the intervention will be     offered to patients of four Seattle-area Safeway Pharmacies, Inc, who are overdue for     prescribed DM medicine refills by at least 6 days. Control subjects will receive usual     pharmacy care at the participating Safeway pharmacies as a comparison. The study will provide     medication adherence support to intervention subjects for 12 months following enrollment with     the goal of improving medication refilling and persistence.   "
228172|NCT00838357|"     This is a research study intended to further investigate the safety and efficacy of     plerixafor in patients with NHL, HD, or MM. Patients who have previously failed stem cell     mobilisation attempts or who have previously received more than one autologous or any     allogeneic stem cell transplant are not eligible.   "
228173|NCT00838370|"     The primary purpose of this study is to prospectively determine whether capecitabine and     5-FU-induced toxicity is preventable by dose reduction prior to start of the first     administration in patients heterozygous or homozygous mutant for DPYD*2A, and to determine     whether this strategy is cost-effective. Secondly, an individualized treatment algorithm for     capecitabine and 5-FU therapy in DPYD*2A mutant patients will be developed and the     pharmacokinetic profile of capecitabine and 5-FU will be assessed.   "
228174|NCT00838383|"     This is a multi-center, randomized study of sitaxsentan administered intravenously to     subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and     cardiac valve replacement procedures that require CPB.   "
228175|NCT00838396|"     The purpose of the study is to evaluate the efficacy and safety of arbaclofen placarbil     (XP19986) compared to placebo in patients with gastroesophageal reflux disease.   "
228176|NCT00838409|"     This study will be a cross-sectional study. The primary aim of this study is to compare the     relationship between neurological function, metabolic measures and health-related behaviors     between normal weight and overweight/obese perimenopausal women.   "
228177|NCT00838422|"     The purpose of this study is to assess the repeatability, reproducibility, and agreement of     central corneal thickness measured by Fourier Domain Optical Coherence tomography (FD-OCT,     OptoVue, USA) with anterior corneal module, 20MHz ultrasound pachymetry equipped with Ocular     response analyzer (ORA, Reichert Ophthalmic Instruments, USA) and 10MHz Ultrasound Pachymetry     (USP).   "
228178|NCT00838435|"     This multicenter, open label study is designed to evaluate the safety of Kuvan® and its     effect on neurocognitive function, blood Phe concentration, and growth in children with PKU     who are 0-6 years old.   "
228179|NCT00838448|"     In this study the investigators will explore the relationship between physical activity and     cannabis use. The investigators will compare regional brain activation detected by imaging     technique(fRMI) before and after exercise in cannabis users and compare results with results     from controls. The investigators hypothesize that the regional brain activation in response     to visual cues (pictures related to cannabis use and food) will be different in cannabis     users than in controls and that exercise will significantly alter brain responses to the     cues.   "
228180|NCT00838461|"     This is intended to provide an initial safety assessment of HSD-016 and also to evaluate how     the drug is absorbed and eliminated and its effect on the body in healthy subjects.   "
228181|NCT00838474|"     Music has been consistently shown to reduce stress and increase weight gain in premature     infants. The mechanism of this presumed improved metabolic efficiency is unknown. We aim to     test the hypothesis that music by Mozart reduces energy expenditure in growing healthy     preterm infants.   "
228182|NCT00838487|"     Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the     improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western     Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral     administration(sulfate glucosamine + chondroitin sulfate sodium) in association with     therapeutic exercises, compared to placebo in association with therapeutic exercises in     individuals with knee OA and not exposed to prior treatment with the products under     investigation.   "
228183|NCT00838500|"     The main objective of this study is to test the hypothesis that a 3 week intensive course of     spa therapy can reduce the risk of leg ulcers in patients with advanced chronic venous     insufficiency (C4a-b and C5 of the CEAP classification) at one year.   "
228184|NCT00838513|"     The purpose of this study is to determine whether eculizumab is safe and effective in the     treatment of adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome     (aHUS).   "
228189|NCT00838578|"     The primary objective of the Phase II portion of this study is to assess the efficacy of     KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil,     leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in     patients with metastatic colorectal cancer.   "
228190|NCT00838591|"     The objective of this clinical study is to examine the safety and effectiveness of     intravenous MN-221 compared to placebo when administered as an adjunct to standard therapy in     subjects experiencing an acute exacerbation of asthma.   "
228191|NCT00838617|"     This is a study in patients with Amyotrophic Lateral Sclerosis (ALS). We will use muscle     ultrasound as a tool to try and see if there are changes in muscle size that can find out how     fast ALS is progressing. This might give us a better way to carry out further studies on new     drugs to see if they might help slow the progression of ALS.      Participants in the study will have muscle ultrasound performed on a few muscles in the arms     and legs at the first visit, and again 3 months later, and one last time 3 months after that.     This takes about 10 minutes, is painless, and involves scanning the muscle with a handheld     device, with some gel applied to the skin. At each visit, there will also be a questionnaire     about symptoms and strength testing.   "
228192|NCT00838630|"     The objective of this randomized, single-dose, two-way evaluation is to compare the     bioequivalence of a test cilostazol formulation to an equivalent oral dose of the     commercially available cilostazol in a test population of 36 adult subjects under fasting     conditions.   "
228193|NCT00838643|"     Evaluation of incidence of invasive aspergillosis in patients who have undergone an     allogeneic stem cell transplantation, with particular regard to the role of galactomannan     assay and of early TC scan in asymptomatic patients.   "
228194|NCT00838656|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin, gemcitabine, and paclitaxel, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller     and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after     surgery may kill any tumor cells that remain after surgery. It is not yet known which     treatment regimen may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well giving one of two chemotherapy     regimens containing carboplatin, gemcitabine, and paclitaxel works in treating patients     undergoing surgery for newly diagnosed primary stage IIIC or stage IV ovarian cancer,     fallopian tube cancer, or primary peritoneal cancer.   "
228195|NCT00842985|"     Marijuana use is a major problem among veterans and non-veterans. A patient's use of     marijuana while engaged in psychotherapy treatment may affect their memory and, therefore,     limit their ability to benefit from treatment. This study is designed to test a new     pharmacotherapy, modafinil, which has the potential to improve memory functioning in     marijuana using individuals.      We hypothesize that modafinil treatment will decrease ratings of drug liking and improve     cognitive measures, especially episodic memory.   "
228196|NCT00842998|"     This study will evaluate the activity of single agent trastuzumab or lapatinib in patients     not previously treated for HER-2 positive (FISH positive) metastatic breast cancer. A     companion biological study will assess factors correlated with sensitivity or resistance to     either one of the compounds   "
228197|NCT00843011|"     This study is an open-label, randomised, single dose study to determine the pharmacokinetics,     safety and tolerability of 2 different formulations of orvepitant 60 mg and the effect of     food in 15 Healthy Volunteers.   "
228198|NCT00843024|"     This study was designed to determine how well the combination medication, sumatriptan and     naproxen sodium, treats migraine headache in adolescents 12-17 years old   "
228291|NCT00844285|"     The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as     compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is     4000 patients and it's objective is to monitor patients for approximately 10 years.   "
228199|NCT00843037|"     This is an open-label phase II study of an investigational drug, sunitinib malate in patients     with advanced malignant paraganglioma or phaeochromocytoma cancer. Paragangliomas (PGs) are     tumours that arise from the para-sympathetic system in the head and neck and sympathetic     system in the thorax and abdomen. Paragangliomas that secrete hormones (catecholamines) from     the adrenal glands are called pheochromocytomas (PCs). In this study, patients whose disease     has advanced or spread despite prior standard therapy, will receive sunitinib for 4-weeks     followed by a 2-week rest period, for up to 12 months, in the absence of disease progression.     Sunitinib is an investigational drug, which has been shown to shrink tumours in several     tumour models. The study will evaluate the efficacy as well as the toxicity profile of     sunitinib when used as an alternative treatment for patients with PG/PC tumours.   "
228200|NCT00843050|"     The purpose of this study is to determine whether P276-00 is safe and effective in treatment     of Mantle Cell Lymphoma that is recurred after or not responding to at least one previous     line of treatment.   "
228201|NCT00843063|"     Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with     symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal     side effects.      The position of H2-receptor antagonists as a step-down therapy after healing of peptic ulcer     or erosions by proton pump inhibitor is unclear.      The objective of this randomized, double blinded control study was to compare the efficacy of     high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or     complicated ulcer/ erosions in patients taking low-dose aspirin   "
228212|NCT00843219|"     Objectives:      Evaluation of an amplitude based gated Positron Emission Tomography (PET) data acquisition     system for all GE Discovery Positron Emission Tomography/ Computed Tomography (PET/CT)     scanners.   "
228248|NCT00843700|"     The aim of the Women's Depression Treatment Study, based in a community mental health center,     is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings     (IPT-TCS) on improving depression and other psychological and social functioning. IPT-TCS is     Interpersonal Psychotherapy with modifications specifically designed for the treatment of     depressed patients with trauma histories seen in community settings.   "
228593|NCT00848055|"     The general aim of the trial is to determine the safety, tolerability and pharmacologic     profile of single escalating doses of AbGn-168 administered subcutaneously or intravenously     to patients with chronic plaque psoriasis   "
228202|NCT00843076|"     Chronic infection by the hepatitis C virus (HCV) is a common cause of liver disease, which     may progress to cirrhosis and eventually liver cancer. The therapeutic indication will depend     mainly on the importance of liver damage (fibrosis), which can be assessed by physical     techniques, blood tests and a liver biopsy. The overall objectives of the project are to     understand how HCV variability may influence the severity of steatosis (accumulation of fat     in the liver), studying 30 patients chronically infected with HCV (half of these patients     infected by HCV genotype 3, versus the other half infected by HCV of another genotype). A     small portion of the biopsy performed for the routine pathology examination will be placed in     special fixation buffer for electron microscopy (EM). Counting and measuring the size of     lipid droplets present in the liver by EM will be used to precisely quantify and characterize     the liver steatosis. A blood sample of patients will also be collected to sequence the viral     genome present in the patient and identify the amino acids involved in an increase in     intracellular accumulation of lipid droplets. This work should clarify the impact of the     viral variability in the severity of steatosis. Ultimately, the identification of viral     sequences responsible for an increase of this phenomenon could be crucial for understanding     the mechanisms involved in the steatosis.   "
228203|NCT00843089|"     Despite immediate symptomatic success after coronary bypass surgery in patients with coronary     artery disease, this effect is not sustained over time since risk factors for coronary artery     disease are still in place. The role of secondary prevention becomes increasingly important     as it can potentially decrease or eliminate the need for another intervention in these high     risk subjects. This project seeks to evaluate the effect of emphasizing secondary prevention     measures in this patient population during hospital admission and through six months     post-discharge.   "
228204|NCT00843102|"     Aim: Determination of frequency and nature of coronary involvement (including epicardial and     microvascular) among scleroderma patients referred for right heart catheterization.   "
228205|NCT00843115|"     To characterize the comorbidities and medications of patients treated with donepezil in a     routine clinical practice and to verify the therapeutic response of these patients.   "
228206|NCT00843128|"     Objective: To evaluate the efficacy of robot-assisted gait training (RAGT) in MS patients     with severe walking disabilities (Expanded Disability Status Scale [EDSS] 5.5-7) as compared     to regular physiotherapy.      Methods: Prospective, randomized, controlled clinical trial comparing RAGT with conventional     walking training (CWT) in a group of stable MS patients (n=40) during an outpatient     rehabilitation program. Inclusion criteria are chronic or secondary progressive MS patients     with EDSS between 5.5-7, stable treatment 3 months before study entry, without generalized     diseases. All patients will sign an informed consent. Following randomization, 20 patients     will be treated with RAGT, 12 sessions over three weeks. The control group will be treated by     CWT, 12 sessions in three weeks. The primary outcome measures will be the Functional     Ambulatory Capacity (FAC) scale and the 6-minutes walking distance. The secondary outcome     measures will be the Time up & Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS     score, FIM score and RAND questioner for quality of life. All tests will be performed by an     external blinded assessor at baseline, after three weeks, and at follow-up after 3 months and     six months.      Importance: We anticipated that Robot-assisted gait training will be found as feasible and     may be an effective therapeutic option in MS patients with severe walking disabilities.   "
228207|NCT00843141|"     The study group of Adults with ADHD who will receive cognitive (executive attention)     computerized training will show significant improvement in ADHD     symptomatology,neuropsychological measures,daily functioning and quality of life.      A significant difference will be found between the study group and the control group (adults     with ADHD that will receive a simplified cognitive training program that does not challenge     their executive functions)on the above measures.   "
228208|NCT00843154|"     The purpose of this study is to determine the effects of Candesartan, once daily (QD), added     to ongoing chronic heart disease therapy in measuring brain natriuretic peptide in patients     with chronic heart failure.   "
228209|NCT00843167|"     RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal     cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal     hyperplasia.      PURPOSE: This randomized phase II trial is studying how well broccoli sprout extract works in     treating women with a diagnosis of breast cancer, ductal carcinoma in situ and/or atypical     ductal hyperplasia.   "
228294|NCT00844324|"     This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single     centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial     oral suspension of candesartan cilexetil (1 mg/mL) and a single 32 mg dose of the candesartan     cilexetil oral suspension (1.6 mg/mL) used in the paediatric program.   "
228210|NCT00843180|"     Undergoing bone marrow transplantation (BMT) is associated with a high level of distress for     patients and caregivers. Clinical research studies have reported benefits from massage for a)     oncology patients, b) children, c) adults and children undergoing bone marrow transplants. A     multi-center study of an intervention using a combination of massage therapy and a laugh cart     to reduce distress in pediatric oncology patients undergoing BMT (PI: Phipps) is completed     with results not yet published. There is still a need for independent studies to isolate the     effect of massage for clinical outcomes (such as improved nausea and pain control) in     children. Furthermore, this study will test the acceptability of an augmented massage     intervention. In addition to provider-child massage, the augmented massage intervention     includes training of the resident parent to provide additional parent-child massage, to     relieve symptoms as needed. The goal of this augmented intervention is the improvement of     symptom management in patients and decreased stress and feelings of helplessness in parents.      We propose a randomized pilot study at the UCSF pediatric bone marrow transplant center to     assess the feasibility of a higher-quality study of the effects of massage in this     population.      Aim 1: Determine the acceptability of a massage intervention for patients and parents on a     pediatric bone marrow transplant unit.      Aim 2: Explore the logistics of implementing the augmented massage intervention at the     bedside offered to consecutive patients over one year's time.      Aim 3: Collect preliminary data for patients and parents including patient clinical outcomes,     quality of life, and satisfaction, and parental stress and mood to allow sample size     calculations for further studies.   "
228211|NCT00843193|"     Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study   "
228213|NCT00843232|"     Type 2 diabetes (T2DM) is characterized by hyperglycemia, insulin resistance, absolute or     relative insulin deficiency, hyperglucagonemia, increased hepatic glucose production,     frequently accelerated gastric emptying and obesity. The known effects of the incretin     hormone glucagon-like peptide-1 (GLP-1) on the metabolism are stimulation of insulin     secretion, inhibition of glucagon secretion and hepatic glucose production, reduction in     gastric emptying and modulation of the appetite. T2DM have disturbances in this system,     providing a rationale for therapeutic use of GLP-1 in T2DM. Furthermore, GLP-1 seems to exert     trophic effects on the beta-cell.      Dipeptidyl Peptidase IV (DPP-IV) inhibitors represent a new class of oral anti-hyperglycemic     agents for the treatment of T2DM. The therapeutic utility of these antihyperglycemic agents     rests on their ability of to increase active (intact) levels of incretin peptides, including     GLP-1 and GIP.      Twenty four T2DM volunteers will be evaluated by a meal tolerance test (MTT) for incretin     hormone measurements, and by the hyperglycemic clamp followed by an arginine test for     assessing the beta-cell function and the acute insulin response. Others parameters as body     composition and basic biochemistry will be also evaluated at Laboratory of Investigation on     Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.      T2DM in elderly are behaving differently. Elderly patients have no increase in liver     production of glucose; when obese, have normal insulin secretion, however, display extreme     resistance to its action. In non obese individuals, the concentration of glucose necessary     for insulin secretion is increased and the action is standard. These findings suggest     therefore that the approach should be differentiated treatment for these individuals.   "
228214|NCT00843245|"     The purpose of this study is to determine how electrical impedance is modified in relation to     extracellular space body fluid retention detected by an electrical bioimpedance method in     patients with heart failure.   "
228215|NCT00843258|"     Developmental dysplasia of the hip is the most common musculoskeletal disorder in infancy,     with a reported prevalence of 2% of all newborns. Although newborn screening programs based     on clinical examination with Ortolani and Barlow tests were introduced in the 1950's and     1960's with early abduction splinting of the 2% testing positive, the prevalence of late     cases warranting surgery has remained stable, around one per 1000. This has led to the     introduction of ultrasound as an additional diagnostic tool, resulting in treatment rates of     until 5-6%. This three fold increase in abduction splinting treatment is partly due to the     initiation of treatment of infants in whom mild hip dysplasia but no hip instability has been     identified. The benefit of early treatment of mild dysplasia in a hip that is neither     dislocated nor dislocatable is unclear. Further, abduction splinting is not without risk,     with avascular necrosis being reported in around 1%. The investigators conducted a masked,     randomized, controlled trial to examine whether mildly dysplastic but stable or instable hips     would benefit from early treatment, as compared to watchful waiting.   "
228216|NCT00843271|"     The purpose of MESA-Lung is to assess the role of endothelial dysfunction and genetic     susceptibility in subclinical COPD.   "
228217|NCT00843284|"     A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to     assess the impact of pregabalin on subjects' pain, quality of sleep, and their general     wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic     pain.   "
228218|NCT00843297|"     Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive     deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH)     lowers mortality and reduces neurologic damage after cardiac arrest. The investigators     evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of     patients after SCA.   "
228219|NCT00843310|"     This study is to determine whether addition of Revlimid to standard therapy will increase     overall and complete response rates compared to historical standard frontline therapy and     whether this combination treatment has fewer side effects than similar combination induction     treatment.   "
228220|NCT00843323|"     In this study, 26 patients were selected and included for full-face photodynamic therapy     sessions. All patients presented signs of photoaging skin and multiple actinic keratosis.     Photographs and Biopsies were taken before and after the procedure. Clinical and histological     aspects as well as immunohistochemical aspects regarding neocollagen induction and tumor     expression were evaluated.   "
228309|NCT00844519|"     The purpose of this study is to determine the potentially beneficial aspects of CCR5     inhibition on inflammation and endothelial function as measured by brachial artery reactivity     in antiretroviral treated HIV patients with an undetectable viral load.   "
228221|NCT00843336|"     The purpose of this research study is to compare the effectiveness of two natural family     planning (NFP) methods that are provided over the internet by the Marquette University     Institute for Natural Family Planning. One of the NFP methods is the use of a hand held     electronic hormonal fertility monitor. The other method involves the self-observation of     cervical mucus to track fertility. Both of the methods will involve placing information about     fertility into an online charting system that automatically displays the days of fertility     and infertility. The investigators are also interested in the influence of mutual motivation     by the woman and her partner in using these methods to avoid pregnancy. The investigators     hypothesize that there will be lower unintended pregnancy rates among those couples who use     the electronic hormonal fertility monitor and among those couples who have a strong     motivation to avoid pregnancy.   "
228222|NCT00843349|"     The investigators would like to study the role of phosphorus metabolism in the development of     certain hormonal problems in people with chronic kidney disease (CKD). More specifically, the     goals of the research are (1) to understand the cause of hyperparathyroidism - a hormone     problem that often develops in patients who have kidney disease and (2) to test whether     decreasing phosphorus intake could help improve or prevent hyperparathyroidism.   "
228234|NCT00843505|"     People who smoke cigarettes and live in rural areas may not have access to a wide variety of     resources to help them stop smoking. This study will evaluate two smoking cessation     programs—an Internet-based telemedicine program and a telephone-based quitline program—among     rural residents.   "
228235|NCT00843518|"     The purpose of this study is to determine whether this drug can help symptoms of aggression     and agitation in patients with Alzheimer's disease.   "
228236|NCT00843531|"     The purpose of this study is to test how safe and effective the combination of RAD001 and     erlotinib is in patients with neuroendocrine tumors.   "
228223|NCT00843362|"     The aim of induction of labour is to initiate labour when maternal and fetal conditions     necessitate delivery before the onset of spontaneous contractions. Prostaglandins are widely     used for induction of labour, and can be administered orally, vaginally, intracervically,     endovenously and by extra-amniotic or intra-amniotic routes. Dinoprostone is one of the     synthetic prostaglandins most commonly used to achieve cervical ripening and labour     induction, and can be administered as tablets, suppositories, gel (vaginal and intracervical)     or as a controlled-release intravaginal pessary. The controlled-release pessary has some     potential advantages: a single application is required; the insert is easily administered and     can be removed as soon as labour starts or if complications ensue. Studies comparing the     dinoprostone vaginal insert to other prostaglandin formulations have shown variable results,     probably influenced by drug administration regimens, indications for induction, and cervical     conditions of the women. The purpose of this study is to assess the efficacy of the induction     of labour using dinoprostone in patients with an unfavourable cervix, and to compare the     efficacy and the cost of 24-hours controlled-release dinoprostone pessary and intravaginal     dinoprostone gel.   "
228224|NCT00843375|"     Colonoscopy is the current state-of-the-art screening procedure for detecting colorectal     cancers. However, compliance with this screening procedure by the public is very low for a     variety of reasons. New screening tools are needed to improve detection of colon cancer.     Biomarkers from stool, urine, serum, tissue and plasma may provide valuable initial screening     tools to sort the population into those that need colonoscopy and those that most likely do     not. This is a cross-sectional study of subjects undergoing clinically-indicated colonoscopy     or who have diagnosed colorectal cancer who are willing to provide biospecimens.   "
228225|NCT00843388|"     A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age     18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days     treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during     hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin,     angiotensin, aldosteron.   "
228226|NCT00843401|"     The general purpose of this study is to evaluate the feasibility, accuracy and performance of     the Nellcor/Covidian 600-x and the Masimo rainbow technologypediatric and neonatal oximetry     sensors over clinically relevant ranges of arterial saturations between 60-100%.      The study objectives are as follows:        1. To evaluate the accuracy of a neonatal sensor in the saturation range of 70-80% in the          following weight category: 0-5kg.        2. To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand)          sensors in the saturation range of 60-80% in the following weight categories: 0-5kg;          and, 5-40kg.        3. To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand)          sensors in the saturation range of 80-100% in the following weight ranges: 0-5kg; and,          5-40kg.   "
228227|NCT00843414|"     To obtain the monocytes (white blood cells) from normal volunteers for the purpose of     studying how proteins, fats, carbohydrates, as well as RNA and DNA for gene expression,     relate to immunity. This information will be compared to other studies in patients with lung     diseases such as Emphysema, Sarcoidosis, and Interstitial Pulmonary Fibrosis.   "
228228|NCT00843427|"     The purpose of this study is to test the effectiveness of constraint-induced aphasia therapy.   "
228229|NCT00843440|"     The efficacy of anti-VEGF treatments such as Bevacizumab in cases of HHT can be considered     because of the molecular mechanisms implied in angiogenesis and HHT, as well as the     mechanisms of action of this type of treatment. Two articles that have recently reported     spectacular improvement thanks to Bevacizumab in patients with HHT complicated with severe     liver involvement and cardiac effects support us in this sense.      Up to now, the only treatment recommended in the severe hepatic forms of HHT is a liver     transplant, the disadvantages of which are both multiple and well known: long waiting lists,     surgical morbidity and mortality, immunosuppressive treatment for life. Furthermore,     treatment with Bevacizumab is not a contraindication, should the drug be ineffective, for a     subsequent liver transplant if necessary.   "
228230|NCT00843453|"     This study was designed to determine whether elderly residents of long term care facilitated     who had been taking proton pump inhibitors (PPI) for more than 12 months were more likely to     have vitamin B12 deficiency than residents not taking PPI, and whether cyanocobalamin nasal     spray improved these subjects' vitamin B12 status.   "
228231|NCT00843466|"     The purpose of this study is to find out if the use of a hand cleanser that adds moisture to     the skin will help improve skin rashes caused by frequent hand washing (hand dermatitis).   "
228292|NCT00844298|"     RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth     of cancer cells, either by killing the cells or by stopping them from dividing. Giving     nilotinib together with combination chemotherapy may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving nilotinib together with combination     chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.   "
228232|NCT00843479|"     Like most endocrine axes, the entero-insular axis is expected to go through an age-related     physiological deterioration, what might contribute to special features of the elderly onset     type 2 diabetes in comparison to middle-age.      Twenty four NGT volunteers will be evaluated by a meal tolerance test (MTT) for incretin     hormone measurements, and by the hyperglycemic clamp followed by an arginine test for     assessing the beta-cell function and the acute insulin response. Others parameters as body     composition and basic biochemistry will be also evaluated at Laboratory of Investigation on     Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.      The characterization of the glucagon-like peptide-1 (GLP-1) production, dipeptidyl peptidase     IV (DPP-IV) activity and/or endocrine pancreas incretin-response at aging, might be an     interesting evidence to reinforce an incretin-based therapeutic approach for elderly onset     type 2 diabetes.   "
228233|NCT00843492|"     The purpose of this study is to evaluate the efficacy and safety of fondaparinux in     comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the     leg veins), whether symptomatic or detected by ultrasound, and pulmonary embolism (blood     clots that migrate to the lungs) in patients with leg injuries below the knee that require a     cast or other type of immobilization but not surgery.   "
228594|NCT00848068|"     To evaluate the effects of FID 114657 on the tear film lipid layer thickness of patients with     dry eye.   "
228237|NCT00843544|"     The overall aim of this research project is to test the effectiveness of an integrative     program, using journaling, yoga breathing instruction, and nutritional manipulation and     supplementation, on quality of life and clinical outcomes in adults with asthma. An     additional aim is to determine whether an integrative approach to asthma management leads to     cost savings when compared to standard clinical care.Patients will be randomly assigned to     either the intervention condition or a waitlist control condition. For the intervention     group, all measures will be obtained at baseline, immediately after the treatment protocol is     completed, and then at three month and six month intervals after the completion of the     intervention. For the control group, data will be collected at the same times as the     intervention group, with one exception: data collected at the completion of the treatment     protocol will be replaced with data collection at six weeks post-baseline for the control     group. Data will be collected using measures of quality of life (Asthma Quality of Life     Questionnaire and SF-12), pulmonary function and health care utilization and expenditures.      Participants assigned to the treatment group will begin in groups of ten. The treatment     protocol will consist of six 1-2 hour sessions over a six-week period as follows:        1. Subjects will attend a two-session class on healthy eating focused on reducing          inflammation-promoting foods in the diet. All subjects will also be started on fish oil          and vitamin C supplements, as well as on a supplement called Kaprex, which is an extract          from hops and rosemary with anti-inflammatory action. Supplements willl be provided free          of charge. Subjects will be provided with a take home supply to begin using.        2. Subjects will attend two classes at CCHH in yoga breathing techniques and will then be          provided with a CD for home study and practice        3. Subjects will attend two guided journaling sessions at CCHH in which subjects will be          asked to write for a 30-minute period about the most traumatic or stressful life          experience to date.   "
228238|NCT00843557|"     The purpose of this study is to better understand the relationship between gender (being a     man or a woman), infections caught in the hospital, and serious illness. Five hundred seventy     patients 18 years of age or older who are critically (seriously) ill and admitted to the     Intensive Care Unit (ICU) for at least 48 hours will participate in this study. Patients will     be studied while receiving regular ICU treatment according to local standards. Blood     specimens will come from patients either as wasted blood (University of Virginia) or blood     collected from patients specifically for the study (Vanderbilt University). All patients will     be followed daily until death or discharge from the ICU. The researchers believe that they     will find a similar risk of infection for men and women overall.   "
228239|NCT00843570|"     Frozen Embryo Replacement (FER)is a fertility treatment by which stored embryos from a fresh     IVF treatment cycle are thawed and transferred into the uterus. Frozen embryos can be     replaced either in the middle of a natural menstrual cycle (Natural FER) or in a cycle where     the woman takes drugs to suppress her own hormones, and then takes Hormone Replacement     Therapy (HRT) to prepare her uterus for the transfer of embryos(HRT − FER).      Both are widely used methods of fertility treatment. However, to date no well designed     studies have been reported in which the two methods have been compared. This study aims to     compare the two treatments in order to establish the best treatment protocol.      The study design is a single centre open randomized controlled trial funded by the Oxford     Fertility Unit.      100 women who are considering FER treatment at the Oxford Fertility Unit and are eligible for     the study will be recruited.      After giving their written consent they will be randomised to one of 2 groups: Natural FER     and HRT FER.      Patients in both groups will be asked to attend one initial visit, which is additional to     patients not taking part in the study.      Subsequent visits will depend on the treatment group but will not be additional for study     participants. All visits requiring ultrasound will involve recording 3−D measurements, which     increases the length of each visit by approximately 10 minutes. A patient satisfaction     questionnaire would be completed at the end of the cycle.      A urinary pregnancy test is performed at home 2 weeks following the embryo transfer visit. If     this is positive then further visits to the unit are arranged to confirm the clinical     pregnancy.      Inclusion in the study would not increase the length of time of either treatment cycle.     Follow up would extend to obtaining pregnancy outcome information.   "
228240|NCT00843583|"     This study aims to investigate the prevalence of obstructive sleep apnea (OSA) in subjects     with resistant hypertension and to evaluate the relationship between parameters of OSA     severity and blood pressure control   "
228241|NCT00843596|"     the purpose of this study is to show that the vacuum control surgical bleeding helps stop     bleeding extraMD (MD: Medical Device) at the orifice of the retrograde cannulation during a     heart with Extra-corporeal circulation (ECC),   "
228242|NCT00843609|"     The purpose of this study is to determine if the incidence and duration of hypoglycaemia (low     blood sugar) is reduced through the use of the FreeStyle Navigator Continuous Glucose     Monitoring System in people with Type 1 diabetes mellitus at good glycemic control. The     investigators hypothesize that the access to real-time continuous glucose concentration data     along with alarms will enable people with type 1 diabetes at reasonable metabolic control to     reduce the time spent in hypoglycaemia.   "
228243|NCT00843622|"     The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for     oral use (snus) can increase the quit rate among cigarette smokers who wish to stop smoking   "
228244|NCT00843635|"     RATIONALE: Biological therapies, such as tadalafil, may stimulate the immune system in     different ways and stop tumor cells from growing.      PURPOSE: This randomized clinical trial is studying how well tadalafil works in treating     patients who are undergoing surgery for cancer of the oral cavity or oropharynx.   "
228245|NCT00843648|"     The immune system is a dynamic, constantly evolving network. Excluding autoimmune diseases,     healthy individuals are also known to have a large number of circulating antibodies that can     recognize proteins of their own tissues. These antibodies are known as natural antibodies and     previous studies suggested that some features of these self components are shared by     individuals in certain physiological states. Thus, monitoring self immunoglobulins can     provide an overview of the various states of the immune system. To do so, and in the process     to obtain systems biology view of the immune system, the newly developed Antigen Chip     technology has been used.      To further investigate this subject we plan to carry out broader investigations that will be     conducted in collaboration with the group of Prof. Eshel Ben-Jacob from the university of     Tel-Aviv and Prof. Irun Cohen from the Weizmann Institute that have the required experimental     and analytical expertise and facilities. The studies will include follow-up on the immune     state of babies and their mothers for several months post birth using the Antigen Chip and     analyzed by the Immune holography method. The investigations will also include comparative     studies between the immune signature of different body fluids, the effects of feeding, and     the effect method and time of labor.   "
228246|NCT00843661|"     -  The aim of the study is to compare the effects of coadministration of ezetimibe 10          mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected          patients treated with protease inhibitors.        -  Single-centre, open, randomized, controlled, prospective pilot study.        -  60 patients will be enrolled in order to reach the target of 50 patients evaluable at          the end of the study. The patients will be randomly assigned to a 6-month treatment with          ezetimibe+fenofibrate or with pravastatin.The visit will be every month.   "
228247|NCT00843687|"     The purpose of this study is to compare the pharmacokinetics and safety of long-acting     injectable risperidone, an atypical antipsychotic medication used for the treatment of     patients with schizophrenia, when it is administered as an intramuscular injection via the     deltoid muscle, compared with intramuscular injection via the gluteal muscle.   "
228249|NCT00843713|"     Recent studies suggest that HIV patients are at increased risk for cardiovascular events;     however, the mechanisms underlying this increased risk remain unclear. Our group was one of     the first to demonstrate that HIV infection is independently associated with accelerated     atherosclerosis, as measured by carotid artery-intima media thickness (IMT), and that     HIV-associated inflammation may be driving this accelerated atherosclerosis. The mechanism by     which HIV disease independent of any drug-specific toxicity increases the risk of     cardiovascular disease during HAART is not known. We hypothesize that even well controlled     HIV infection is independently associated with cardiovascular risk and that further     decreasing HIV-associated inflammation adding newer antiretroviral agents will also decrease     cardiovascular risk.      We will perform a small clinical trial of approximately 50 HIV-infected patients each to     study the relationship between HIV infection, inflammation, thrombosis, atherogenic     lipoproteins, and measures of atherosclerosis. We propose the following specific aims: Aim 1:     To determine the influence of traditional and novel markers of inflammation on endothelial     function and IMT progression; Aim 2: To determine if intensification with raltegravir in     subjects on long-term antiretroviral therapy with clinically undetectable HIV RNA levels will     improve endothelial function, and to determine if this effect is mediated by alterations in     inflammatory markers, lipoproteins and/or thrombotic factors. For Aim 2, subjects from 2     randomized, double-blind, placebo-controlled raltegravir intensification studies will be     asked to co-enroll in this cardiovascular study.   "
228250|NCT00843726|"     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the     tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation     therapy is more effective in treating patients with non-small cell lung cancer.      PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy     regimens and to see how well they work in treating patients with stage I or stage II     non-small cell lung cancer.   "
228251|NCT00843739|"     Respiratory difficulty is one of the primary factors leading to death in patients with     Idiopathic Parkinson's Disease (IPD). The progressive degeneration of a family of segregated     motor and non-motor circuits in the brain results in motor and non-motor dysfunction.     Breathing and swallowing are well known to be affected in IPD, and attention to these     functions is fitting since most patients eventually experience morbidity and even mortality     as a result of this dysfunction. Patients with IPD typically become sedentary and lose     endurance, maximal fitness levels and overall pulmonary function. Much of the research focus     has been on the motor symptoms of IPD (tremor, rigidity, bradykinesia) yet the pulmonary     complications are perhaps ultimately the most important disability. The inability to generate     adequate respiratory pressure is responsible for reduced cough magnitudes and cough response     times. Cough is critical for the clearance of foreign materials in the airway helping to     reduce infiltration of bacteria and subsequent respiratory infection. With reduced cough     function an increased risk for pulmonary disease due to a reduced ability to protect the     airways occurs. Moreover, the recognized debilitating disruptions to voice and speech     characteristics that limit communication, care taking, employment opportunities and social     interactions are also a result of poor respiratory function. There are a number of promising     outcomes from an expiratory strength-training program. By increasing expiratory muscle     strength and expiratory pressure generation, effective breathing, clearance of the airway,     production of a louder and clearer voice as well as improved swallowing can occur. These     explicit outcomes are predicted based on our experience with the use of an innovative     device-driven, home-based expiratory strength training program focused on the expiratory     muscles of respiration.      The aims of this study are to: 1) Investigate the activity of expiratory muscle strength     training (EMT) in patients with idiopathic Parkinson's disease (IPD), 2) Determine the effect     of increased expiratory force generation on breathing, cough magnitude, speech production,     and swallowing, 3) Determine the effect of increased expiratory force generation on the     patient's perception of speech change, 4) Determine the effect of Dopamine-replacement     therapy (Parkinson's medications) on breathing, coughing, speaking, and swallowing measures.   "
228252|NCT00843765|"     Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project     under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation     and secondary prevention of ischemic stroke is same or better than that of WM.   "
228253|NCT00843778|"     To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on     therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)   "
228254|NCT00843791|"     The purpose of this study is to learn more about how insulin resistance (inability to process     glucose correctly resulting in mildly elevated glucose levels) affects the hormone ghrelin.   "
228255|NCT00843804|"     The Oncoped 2006 study implements a multicenter prospective surveillance module for     nosocomial infections in pediatric cancer patients.   "
228256|NCT00843817|"     Serine proteases belonging to the elastase family are mainly responsible for lung tissue     destruction as observed during cystic fibrosis. But anti-inflammatory therapies based on     systemic or aerosolized protease-inhibitors administration, have not given the expected     results until now. One reason would be the impaired access of therapeutic inhibitors to their     molecular targets. It was recently shown that neutrophils actively secrete neutrophil     extracellular traps (NETs) made of DNA that binds cationic proteases among other molecules.     NETs together with DNA passively released from dead neutrophils contribute to the viscosity     of CF expectorations which explains that rhDNase treatment fluidifies expectorations and     improves the patient status. Preliminary experiments in our laboratory have shown that DNA     degradation was associated with a significant increase of proteolytic activity in the sputum     soluble fraction. However the efficacy of exogenous inhibitors is also improved in these     conditions. Using the specific substrates and methodologies that we developed previously to     measure cell-surface associated proteolytic activities, we will study the effects of DNase on     the activity of individual proteases, their biodistribution in sputum and their regulation by     potential therapeutic inhibitors. Enzymatic, immunochemical and microscopic (confocal and     scanning) techniques will first be used for ex vivo studies on sputa freshly collected at the     adult and paediatric CRCM in Tours, then on sputa from patients before and after     administration of aerosolized rhDNase. We hypothesize that a better understanding of the     biodistribution of neutrophil serine proteases and especially their binding to DNA will help     designing new therapeutic strategies that facilitate inhibitor access to their protease     targets.   "
228280|NCT00844142|"     Efficacy - To assess efficacy of etanercept versus sulfasalazine when added to NSAIDs in     patients with moderate to severe active early axial spondyloarthritis duration of ongoing     axial symptoms of less than 5 years. Primary outcome is change of active inflammatory lesions     in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters     are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years.     Comparisons will be made within the two treatment arms and compared to baseline. At the 1     year extension phase comparisons will be also made between year 1 and year 2. At the end of     the extended study a pelvic x-ray is planned.   "
228852|NCT00849667|"     This research is being done to find out if Carboplatin and Taxane works better alone or when     given with an experimental drug called MORAb-003(farletuzumab) in subjects with first     platinum sensitive relapsed ovarian cancer.   "
228257|NCT00843830|"     This study is being done to determine whether it is possible to use an investigational     vaccine that consists of dendritic cells in patients with pancreas cancer. Dendritic cells     are immune cells that are obtained from your blood that are important in the body's immune     response to foreign substances. The vaccine would be injected directly into a tumor that has     spread to the liver after a short course of radiation therapy has been given to that tumor.     The study will try to determine if this treatment would be safe and effective in treating     this cancer.      This is a phase 1 pilot study of this treatment. Phase 1 trials test the best way to give a     treatment where little is known about its possible risks or benefits. Phase 2 studies then     test the possible benefits of a treatment and may show the specific situations where they are     seen. Promising treatments are then tested in Phase 3 trials which compare the new treatment     to standard treatment in a larger group of patients. Phase 4 trials are those conducted on a     treatment after it has been approved for general use outside of research. A pilot study tests     a treatment in a small number of patients to learn if and how the treatment could be tested     in a larger group. Pilot studies can be performed at any phase but are commonly performed in     the earliest phases of research on a treatment.   "
228258|NCT00843843|"     This research will examine why sleep restriction reduces the body clock's response to bright     light. The results will enable the optimization of the bright light treatment of people who     suffer from circadian rhythm sleep disorders, which include shift work sleep disorder, jet     lag, delayed sleep phase syndrome and winter depression, thereby improving public health and     safety, well-being, mood, mental function, and quality of life.   "
228259|NCT00843856|"     Membranous nephropathy is a common cause of nephrotic syndrome in adults. It is difficult to     treat and if persistent leads to end stage renal failure in a significant number of patients.     It is currently treated in this institution with tacrolimus monotherapy. This is effective in     the majority of patients in reducing proteinuria but the remissions are often partial and     patients tend to relapse when the tacrolimus treatment is stopped. We propose to use     mycophenolate mofetil in combination with tacrolimus with the aim of obtaining a more     complete initial response to treatment, a decreased rate of relapse on withdrawal of therapy     and less progression of renal failure. This will be a randomised control trial, patients will     be randomised to receive treatment with tacrolimus alone (our current standard therapy)or     treatment with tacrolimus and mycophenolate mofetil. Participants will receive treatment for     up to 2 years and then be monitored for relapse of their nephrotic syndrome.      Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of     membranous glomerulonephritis it is likely to improve the initial response to treatment and     reduce the risk of relapse on stopping therapy.   "
228260|NCT00843869|"     This study is focused on identifying the prevalence of passive or active smoke exposure and     zinc deficiency in a cohort of patients who meet the objective and subjective guidelines for     chronic rhinosinusitis set forth by the Sinus and Allergy Health Partnership.   "
228262|NCT00843895|"     The purpose of this study is to identify the S. pneumoniae serotypes strains and to determine     antibiotic susceptibility.   "
228263|NCT00843908|"     The aim of this study is to assess whether the Miniarc suburethral sling is equivalent to the     TVT in the treatment of women with urodynamic stress incontinence (USI). If equivalence is     proven, the advantages to women with USI will be potentially significant since the Miniarc     may be carried out as an office based procedure, negating the need for an anaesthetic and     hospital admission. The investigators null hypothesis is that there is no difference in     subjective or objective outcome between the TVT and the Miniarc in the treatment of USI.      Eligible women will be initially assessed with a full history and examination, King's Health     Questionnaire and twin channel subtraction cystometry. They will be randomised (using a     series of numbered opaque envelopes) to undergo either the TVT or Miniarc. Follow up will be     at 6 weeks, with a subjective outcome measure and at 6 months with a repeat subjective     assessment and repeat twin channel cystometry.   "
228264|NCT00843921|"     This study is based on the hypothesis that a new drug N-carbamylglutamate (Carbaglu®) will     enhance the ability of the liver to dispose of toxic ammonia which accumulates in several     metabolic diseases including urea cycle disorders and organic acid disorders.   "
228266|NCT00843947|"     This is a Phase II trial designed to evaluate the efficacy and toxicity of RIST, conditioned     with fludarabine and busulfan, using G-CSF mobilized PBSC from an HLA-matched sibling or an     unrelated volunteer donor. The primary endpoint of this study is day 100 TRM (Treatment     Related Mortality). Secondary endpoints include response, engraftment times, acute and     chronic GVHD, chimerism, toxicities, progression-free survival and overall survival.      Objectives        -  To assess the efficacy and toxicity of Reduced Intensity Transplant (RIST) for patients          with hematological malignancies, conditioned with fludarabine (Fludara®) and busulfan          intravenous (Busulfex™).        -  To evaluate progression-free survival and overall survival.        -  To determine donor chimerism.        -  To assess the risk of acute and chronic graft versus host disease (GVHD).   "
228267|NCT00843960|"     Medication-related non-adherence increases the risk of rejections and associated graft loss     after solid organ transplantation. A randomized controlled intervention will use adherence     enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence     will be assessed by patients' self-report and based on immunosuppression level. All     non-adherent patients will be randomly designed to either intervention or control group.     Multi-module interventions include patient education, electronic medication event monitoring,     and a combined behavior and symptom management. Longitudinal follow-up is envisioned after     initial intervention.   "
228268|NCT00843973|"     The purpose of this study is to find out if the cells in bone graft samples collected using a     reamer are similar to the cells in bone graft samples collected using the iliac crest bone     graft method.   "
228269|NCT00843986|"     This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin     antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated     heart failure (ADHF).   "
228298|NCT00844376|"     The purpose of this study is to estimate the relative bioavailability of the commercial     tablet with one prototype extemporaneous preparation suspension formulation, to assist with     internal decision making on formulation development.   "
228299|NCT00844389|"     The purpose of the study is to evaluate if near-to-infrared light stimulation can improve     retinal ganglion cell function in glaucomatous patients.   "
228270|NCT00844012|"     Because ovarian sex steroids fluctuations during the menstrual cycle are implicated in the     pathogenesis of the endometriosis-related chronic pelvic pain (CPP), the oral contraceptives     (OCs) are used with non-contraceptive indication for this disorder.      To date, OCs are widely used as medical treatment in patients with endometriosis, in     addition, they are recently experimented as post-surgical therapy. Traditional cyclic     regimen, with 21 days of active pills with 7 days of placebo or suspension, is usually     adopted. Furthermore, recent studies suggested that long-term continuous OCs use can be     effective in the postoperative period both as second- and third- line treatments after cyclic     regimen failure. In these studies a combined treatment with ethinilestradiol (0.02 mg) plus     desogestrel (0.15 mg) were used and compared with baseline or ciproterone acetate.      A recent study showed a deeper ovarian and endometrial suppression with continuous OCs in     comparison with cyclic OCs, providing a physiological rationale for continuous OCs use for     noncontraceptive indications. Furthermore, to date, no study compared post-operative     continuous versus cyclic OCs in patients with endometriosis-related CPP.   "
228271|NCT00844025|"     The investigators propose that clinical pharmacist interventions would reduce the rate of     adverse drug events in elderly patients taking potentially inappropriate medication.   "
228272|NCT00844038|"     Steven-Johnson's syndrome, or great multiform erythema, appears as a systemic disturbance,     with skin involvement and mucous membranes, related to several factors, such as, viral or     bacterial infections and mainly the administration of medicines, in general painkillers and     antibiotics. The objective of this work is report the emergence of ulcerative vesicle -bubble     chronic disease in areas of lips, gum, tongue and genital mucous membrane in a 26 year-old     patient, leucoderma and masculine gender, in treatment of breathing infection with     sulfametoxazol-trimetropima, having been diagnosed as syndrome of Steven-Johnson.   "
228273|NCT00844051|"     Rates of confirmed influenza illness in vaccinated and non-vaccinated children will be     compared between schools with and without vaccination programs. The investigators hypothesize     that in addition to lowering rates of influenza in vaccinated children, raising vaccination     rates by 30-40% through school-based vaccination programs will decrease incidence of     influenza in non-vaccinated children attending those schools compared to non-vaccinated     children in schools with low vaccination rates.   "
228274|NCT00844064|"     In this national Phase I dose-escalation study the safety and tolerability of AP 12009 is     evaluated in adult patients with advanced tumors known to overproduce TGF-β2, who are not or     no longer amenable to established therapies.   "
228275|NCT00844077|"     Barrett's esophagus can progress to esophageal cancer, but it doesn't always. Current     treatment is frequent surveillance via upper endoscopy with multiple biopsies to look for     changes (dysplasia). Pathologists vary dramatically in their interpretation of Barrett's     Metaplasia versus dysplasia and consensus is very difficult to achieve. The investigators     propose a longitudinal study of subjects with confirmed Barrett's intestinal metaplasia     without dysplasia to look for predictive factors for transformation to dysplasia or cancer.     Potential biomarkers can be found in serum, plasma, urine, frozen or fixed Barrett's and     Normal esophageal mucosa. In addition, the investigators are testing a brushing technique     from CDx, Inc. for predictive factors. Subjects must have pathologically confirmed Barrett's     intestinal metaplasia without history of dysplasia to be on this longitudinal study.   "
228276|NCT00844090|"     In spite of several new medications and insulins for the control of blood sugars in patients     with diabetes, a large number of patients do not have good control. This likely due to     inability to carry out regular activities and self-care behaviors such as taking meds     regularly, keeping a good diet, exercise etc. This inability to carry out self care lifestyle     changes may be due to a condition called apathy. Apathy is a lack of motivation and     persistence. In this study we will attempt to treat apathy with a medication called     methylphenidate for 6 months and see if blood sugar/diabetes control improves.   "
228277|NCT00844103|"     The purpose of this study is to determine how well tolerated and safe AZD8566 is when given     over 10 days, at different dose levels. This study will also determine how AZD8566 is     distributed around the body and how it leaves the body.   "
228293|NCT00844311|"     The purpose of this trial is to study whether addition of different doses of human chorionic     gonadotropins during controlled ovarian stimulation for patients undergoing IVF will improve     the number of top-quality embryos.   "
228310|NCT00844532|"     To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent     System in subjects with atherosclerotic de novo or restenotic lesions in the native common     iliac artery and/or native external iliac artery.   "
228278|NCT00844116|"     The investigators aim to demonstrate that spirometry performed on line with a technician in     a remote place from the patient has the same efficacy as the one performed personally. As a     previous study the investigators analyzed the inter-observer agreement between two pulmonary     function technicians from both centers taking part in the study: San Pedro de Alcántara     Hospital (Cáceres) and Carlos III hospital (Madrid). The main study will be broad (226     patients derivates from primary care to pneumology consultation), prospective, aleatorized,     crossed, blind and controlled. The patients will be aleatorized in two groups: 1) personal     spirometry: performed in a conventional way; 2) telematic spirometry: performed remotely on     line. The same pulmonary function technician, who will carry out the spirometries     personally, will be located in a nearly room. The technician will control the computer office     and the spirometer software in the patients's room with another computer. By means of     teleconference, the technician will indicate the patient to start the maneuver. After 20     minutes from the end of the first spirometry, the patients will complete the protocol of the     following group. The mean values of FVC, FEV1 and FEV1/FVC, the mean time of spirometry     performance, the mean number of spirometric maneuvers performed, are compared between both     groups by t proof for paired data. The comparison of the percentage of proofs with non     acceptability or reproducibility criteria will be made by X2 test. The analysis will be made     blindly. The inter-observer and intra-observer agreement will be evaluated by analysis of     intraclass correlation for FVC and FEV1 values.   "
228279|NCT00844129|"     The purpose of this study is to determine the incidence and clinical history of     neurofibromatosis type 1-related spinal abnormalities.   "
245802|NCT01067079|"     This study will evaluate the immunogenicity of rabies vaccine at 13 months, 3 year and 5     years after initial vaccination, administered in two different post-exposure vaccination     schedules   "
228281|NCT00844155|"     This proposed pharmacokinetic study will test the hypothesis that in critically ill patients     with respiratory failure requiring mechanical ventilation such as might be anticipated to be     needed to treat patients with severe influenza pneumonia, oseltamivir administered enterally     via nasogastric tube, with and without concomitant food or alimentation, will have similar     oral bioavailability to that observed in ambulatory adults ill with influenza in whom     oseltamivir therapy 75 mg BID is efficacious and well tolerated. Additionally, this     experiment will test the hypothesis that increasing the dose (150 mg), with and without     concomitant enteral feeding, will show a proportionate increase in bioavailability. Relative     oral bioavailability will be assessed from plasma concentration vs. time over 12 hrs and     urinary recovery of drug from 0 to 48 hrs after administration.   "
228282|NCT00844168|"     This phase I trial studies the side effects and best dose of sorafenib tosylate in treating     patients with liver cancer who have undergone a liver transplant. Sorafenib tosylate may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth and by     blocking blood flow to the tumor. Giving sorafenib after liver transplant may be an effective     treatment for liver cancer   "
228283|NCT00844181|"     Our central hypothesis is that baroreflex sensitivity is attenuated in black women compared     to white women, and that this dysregulation will be apparent during orthostatic challenges.     We expect that the cumulative stress index (CSI), a measure of maximal orthostatic tolerance,     is higher in Black women (BW) compared to White women (WW).   "
228284|NCT00844194|"     The primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP)     patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given     as 60 mg to 120 mg once daily (QD) leads to a clinically relevant improvement as measured by     the change in Brief Pain Inventory (BPI) 24 hours average interference score from baseline to     after 12 weeks. A clinically relevant improvement will be demonstrated if the confidence     interval for the mean change from baseline does not lie above the clinically relevant change     of -1.35. If statistically significant results are obtained for the DPNP patients with MDD,     then the same evaluation will be performed for the DPNP patients without MDD in another     confirmatory analysis.      As secondary objectives the study will compare the two groups (MDD+/MDD-) regarding efficacy     of duloxetine on BPI severity scales, the distribution of different percentages of pain     reduction among the patient population, and the patients and physicians impressions of     severity and improvement of pain.      The study will also compare treatment outcomes regarding patient-relevant functionality and     quality of life (QoL) between the two groups (MDD+/MDD-) by evaluating each single BPI     interference item, the Short Form 12 (SF-12) Health Questionnaire and the West Haven     Multidimensional Pain Inventory (MPI).      As a third group of secondary objectives the efficacy of duloxetine of the psychological     symptoms (e.g. depression) of DPNP patients with or without depression will be assessed using     the Hamilton depression scale, the Beck Depression Inventory-II and the hospital Anxiety and     Depression Scale.      Further the effect of duloxetine treatment on fasting blood glucose (FBG) and hemoglobin A1c     (HbA1c) will be evaluated.      To monitor safety and tolerability, treatment discontinuation rates, treatment emergent     adverse events, change in vital signs, laboratory results and suicidal thoughts will be     assessed.   "
228285|NCT00844207|"     The primary objective is to estimate the relative bioavailability of fixed azithromycin /     chloroquine combination tablets relative to co-administered individual tablets of     azithromycin and chloroquine.   "
228286|NCT00844220|"     The primary objective of this study is to analyze the clinical value of a therapeutic     management strategy based on the results of coronary CT angiography and functional MRI. The     clinical value of CT and MRI will be analyzed in patients with suspected coronary artery     disease.   "
228287|NCT00844233|"     The objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in the     neoadjuvant treatment (i.e. the Irinotecan Bead is administered prior to surgery) of     resectable liver metastases from colorectal cancer.   "
228288|NCT00844246|"     The purpose of this study is to examine the feasibility, acceptability and effectiveness of     implementing the American Academy of Pediatrics (AAP's) recommendation that clinicians     provide developmental surveillance at all well child visits and institute developmental     screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months     of age.   "
228289|NCT00844259|"     The aim of this study was to verify the use of communicative functions by children with DS in     two interaction conditions: interaction with therapist and interaction with parent.   "
228290|NCT00844272|"     Study objective: Feasibility and efficacy of a standardised psychosocial intervention     (psychoeducation) in substituted opioid dependent patients   "
228295|NCT00844337|"     The primary aim is to establish the non-inferiority of several simplified, home-based     antibiotic regimens compared to the standard course of parenteral antibiotics for the empiric     treatment of suspected sepsis in Bangladeshi young infants whose parents refuse     hospitalization. Three alternative regimens will be compared with a standard (reference)     regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven     days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin     twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days     followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once     daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily     for five days.      Hypothesis      The proportion who fails treatment will be 10 percent in the reference group and the     alternative treatment groups. An alternative therapy will be considered non-inferior to the     standard therapy if the failure rate in the alternative therapy exceeds the failure rate in     the injectable therapy by less than 5 absolute percentage points.      Secondary Objectives:        -  To identify baseline clinical predictors of treatment failure in severe infections in          young infants.        -  To determine the proportion of relapse (young infants who were considered cured by day 7          but developed any of the signs of suspected severe infection by day 14).   "
228296|NCT00844350|"     The specific aims of this study were to assess whether letrozole as an aromatase inhibitor     plus hCG or OT alone, or in combination compared with CC, improves ovarian response.Ethical     design of this study is based on the ethical guidelines of the Iranian Medical and Health     Ministry which is accepted by Tabriz medical university ethical committee .   "
228297|NCT00844363|"     Ultra-violet light B (UVB) therapy has been used by dermatologists to treat psoriasis for     decades. Only a few studies have begun to dissect the mechanism of how NB-UVB therapy causes     lesion resolution. Results from this study will aid in identifying other diseases that may be     treated successfully with NB-UVB. If we can identify the mechanism of action of this therapy,     this may give us additional new therapeutic targets for psoriasis and other diseases. Our     overall hypothesis is that UVB induces changes that will indicate a mechanism of action of     this therapy in psoriasis.   "
256583|NCT02592564|"     This study evaluates underlying psychological and biological mediators in Internet-delivered     cognitive behavior therapy for adults with social anxiety disorder.   "
228300|NCT00844402|"     Primary biliary cirrhosis (PBC) is frequently associated with hypercholesterolemia and     possibly with an increased cardiovascular morbidity and mortality. Statins lower serum     cholesterol levels and may thus improve the cardiovascular risk in PBC patients. The aim of     our study therefore was to prospectively examine the efficacy of low-dose atorvastatin on     indicators of cardiovascular risk such as dyslipidemia and vascular function as well as     safety in patients with PBC.   "
228301|NCT00844415|"     To investigate the safety and tolerability of dabigatran etexilate capsules in a small group     of eight adolescent patients.   "
228302|NCT00844428|"     The purpose of this study is to determine whether eculizumab is safe and effective in the     treatment of adolescent patients with plasma therapy-sensitive Atypical Hemolytic-Uremic     Syndrome (aHUS).   "
228303|NCT00844441|"     RATIONALE: Gathering information about patients with myelodysplastic syndrome or acute     myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital     until blood counts return to normal, may help doctors learn more about a patient's quality of     life, use of medical services, and the cost of these services.      PURPOSE: This clinical trial is studying early discharge and outpatient care in patients who     have undergone chemotherapy for myelodysplastic syndrome or acute myeloid leukemia.   "
228304|NCT00844454|"     The purpose of this study is to compare the effectiveness of percutaneous ethanol ablation     using a multi-pronged needle (QFEA) with that of percutaneous radiofrequency ablation (RFA)     in the treatment of early-stage hepatocellular carcinoma (HCC).   "
228305|NCT00844467|"     The purpose of this study is to establish retrospectively the incidence rates of invasive     pneumococcal disease in children aged less than 5 years. The investigators allocate the El     Hasa region for the study because it has higher incidence of sickle cell anemia. The study     will include data from 2003 to 2007(before introduction of the vaccine) and then for 2008 and     2009 (after introduction of the vaccine).   "
228306|NCT00844480|"     This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be     administered intravenously to people who have suffered an acute spinal cord fracture. The     goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this     population. Outcome measures will include bone density determinations over a one year period.   "
228307|NCT00844493|"     This study will validate a model for testing new vaccines designed to protect against     intestinal infections with enterotoxigenic Escherichia coli (ETEC). ETEC is one of the most     common causes of diarrhea in developing countries and is a common cause of travelers     diarrhea. Vaccines are now being developed and their development will be facilitated if we     have a valid model for testing these vaccines in human volunteers. We anticipate that the new     vaccines will be given to volunteers and they will then be given a dose of virulent ETEC     bacteria. If the vaccine is effective, the volunteers should not development diarrhea, but if     the vaccine is not effective, the volunteers will have diarrhea for a few days.      During this study, we will validate a minimum dose of virulent ETEC bacteria which is     sufficient to cause diarrhea in healthy adult volunteers and to identify conditions that can     make this model reliable.      We will also determine, in a follow-up group of volunteers, if being exposed to the ETEC     bacteria previously will protect against a subsequent illness when they are exposed to the     same bacteria a second time. We believe that the previously exposed group will be protected     and we will study the immune response to these exposures to help design vaccines that can     accomplish this kind of protection.   "
228308|NCT00844506|"     The purpose of this study is to determine whether the addition of cyclophosphamide to the     treatment with the p53-SLP vaccine improves clinical efficacy and immunogenicity of the     p53-SLP vaccine in ovarian cancer patients.   "
228312|NCT00844558|"     Knee Osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is     one of the most disabling problems facing the growing population of older adults. The purpose     of this research is to reduce disablement of older adults with symptomatic knee     osteoarthritis.   "
228313|NCT00844571|"     The purpose of this study is to determine whether the e-learning program about the     recognition of child maltreatment is effective in nurses on the A&E department compared to a     control group.   "
228314|NCT00844584|"     Atrial fibrillation (AF) is a common supraventricular arrhythmia, the incidence of which     increases with age. The aim of treatment of atrial fibrillation is to restore sinus rhythm     and return the heart to atrioventricular synchrony, avoiding the risk of thromboembolism. The     fact that pharmacological therapy of AF is at best 50% effective has led to a search for     surgical approaches over the last 20 years.      Maze procedure was a classic method to treat AF. However, it is such a complex procedure that     very few surgeons have adopted it. A few minimally invasive procedures to create transmural     lesions which mimic MAZE procedure have been introduced. One of the mostly favored methods is     catheter-based radiofrequency ablation, another one is video assisted epicardial     radiofrequency ablation through small thoracic incisions in operating room.      Recently, we invented an epicardial radiofrequency ablation method under totally     thoracoscope, which further minimized the surgery trauma and increased the cosmetic effect.   "
228315|NCT00844597|"     The specific aim of this Phase I/II study is to assess the safety of intravenous administered     Morpholino oligomer directed against exon 51 (AVI-4658 PMO).   "
228316|NCT00844623|"     The purpose of this study is to determine whether activation of a prodrug after intratumoral     gene transfer is safe in humans, and to determine dose levels for further clinical     development.   "
228317|NCT00844636|"     The objective of this study was to determine if blunt needle use during cesarean section     closure protects against glove perforation and percutaneous injury to the surgeon and     surgical assistant. A secondary objective was to determine physician satisfaction with blunt     needles during the surgery.   "
228318|NCT00844649|"     Phase III Metastatic Pancreatic Cancer   "
228319|NCT00844662|"     Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food,     reducing the amount that the body can absorb.      The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in     subjects requiring haemodialysis, compared with a marketed phosphate binder, sevelamer     hydrochloride.   "
228329|NCT00844792|"     The purpose of this study is to see if an intervention of antioxidants(vitamin E, selenium     and lycopene) can change (reduce) prostate tumor size and alter certain markers that can     affect tumor growth and prostate cancer aggressiveness.   "
228320|NCT00844675|"     The purpose of this study is:        -  To examine if oral administration of Pariet (proton pump inhibitor, 20mg tablets, twice          daily for 5 days) before Endoscopic mucosal resection(EMR) exhibits preventive effects          of ulcer bleeding compared with placebo group (preoperative administration of placebo)        -  To evaluate the effects on the suppression of acid secretion of preoperative          administration of an Proton pump inhibitor   "
228321|NCT00844688|"     For the majority of patients, metastatic HCC is incurable and patients should be considered     candidates for clinical trials when appropriate. Till recently there was no worldwide,     approved local or systemic therapy for advanced HCC and the available therapies for advanced     unresectable and/or metastatic HCC have limited clinical values, with low response rates and     little impact on the natural history of the disease. Furthermore, the toxicities associated     with these agents can be severe, requiring careful patient selection, and this dramatically     decreases the number of patients who may benefit from therapy. The SHARP trial established     the survival benefit of Sorafenib in Advanced HCC but the results yet remain humble. The need     for more effective therapies is still there.      Study Objectives      The primary objective of this phase II study is to evaluate the efficacy and safety of     Sorafenib and Gemcitabine combination in patients with advanced HCC.      Safety data and limited efficacy data will be collected for this combination in the study.     All Drug-Related Adverse Events, all Adverse Events NCI CTCAE Version 3.0 Grade 3 or higher,     and all Serious Adverse Events regardless of causal relationship to study drugs will be     recorded in this study.   "
228322|NCT00844701|"     The purpose of this study is to evaluate the relationship between craving to smoke and areas     activated in brain. The researchers are using functional magnetic resonance imaging (MRI)     that measures brain blood flow, or perfusion, to study this brain activation.   "
228323|NCT00844714|"     The purpose of this investigation is to determine the effects of Rituxan therapy in     individuals with rheumatoid arthritis on endothelial function and other markers of     endothelial function   "
228324|NCT00844727|"     Preliminary data indicate a protective effect on the development of duodenal polyps by coxib     treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib for     1 year would stop or reverse the development of premalignant adenomatous lesions in the     duodenal mucosa of FAP patients.   "
228325|NCT00844740|"     Currently, large oral doses of phosphate and 1,25(OH)2D (calcitriol) are the standard     treatment of patients with familial hypophosphatemic rickets (XLH). While this therapy is     effective in healing the rickets, it is often limited by development of complications due to     the high dose of medications required to achieve cure. Among them are the development of     calcifications in the kidneys and secondary hyperparathyroidism (HPT) which in some patients     may cause complications like high blood calcium level, high blood pressure and damage to the     kidney. A drug to treat secondary hyperparathyroidism was just developed. In a short term     study we found that it might help the treatment of XLH, by allowing the use of lower doses of     the both phosphate and calcitriol. In the present study we will learn if indeed the addition     of this new medicine (Cinacalcet) to the long-term treatment will allow the use of lower     doses of both phosphate and calcitriol and consequently lower the risk of complications.   "
228345|NCT00845000|"     This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third     party-blind study of preladenant (SCH 420814) in participants with Parkinson disease (PD) to     be conducted in conformance with Good Clinical Practices. This trial will investigate the     effects of single doses of preladenant and placebo on the dyskinesia and antiparkinsonian     actions of a levodopa infusion. The study will examine 10 mg (low dose) or 100 mg (high     dose) study drug, given as single, oral administrations in conjunction with intravenous (IV)     levodopa infusion and oral carbidopa.   "
231257|NCT00879502|"     This study will examine whether individuals with the fragile X genetic premutation are likely     to have emotional, social, and memory deficits and how the brain may be involved in these     deficits.   "
228326|NCT00844753|"     The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent     Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive     Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention     Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where     the atomoxetine will have a dose titration over a 6 week period. All children will be seen     weekly during this titration period, with additional visits at Week 8 and Week 10. Families     assigned to the PMT arm will have an additional weekly meeting with a clinician for a total     of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with     their children. Subjects who are clinical responders (ADHD Responders and Compliance     Responders) from the 10 week study period will be followed every 4 weeks in a 24-week     extension study. Subjects who are clinical nonresponders will continue in PMT if they     received PMT during the double-blind phase, and they will receive an open trial of     atomoxetine if they were on placebo during the double-blind phase. All subjects (responders     and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for     24 weeks after the completion of the double-blind phase.   "
228327|NCT00844766|"     The hypothesis underlying this study is that whilst there is no home-screening test for     lactose intolerance, this test would have significant value as lactose tolerance tests and     breath hydrogen tests are expensive and time consuming. Therefore, it would be highly     beneficial to validate a simple home-screening test.      This study will validate a simple home-screening test that uses lactose and not milk.   "
228328|NCT00844779|"     Non alcoholic fatty liver diseases (NAFLD) are represented by two main pathological     conditions, hepatic steatosis (HS) and non alcoholic steatohepatitis (NASH), which are     characterized by the accumulation of fat in the liver. The diagnosis of these two entities is     achieved by histology and neither imaging nor biochemical markers are accurate enough to     discriminate them. At the contrary of HS, NASH features hepatocyte necrosis, inflammation and     fibrosis of variable intensity that could progress and ultimately evolve to cirrhosis.     Therefore, it is important to distinguish between HS and NASH in order to treat the patients     accordingly. In this study, the investigators aim to understand the molecular mechanisms that     govern the transition from benign steatosis to complicated NASH. The investigators will     analyze by Q-RT-PCR and DNA microarray technologies in the liver of obese patients, the     expression of genes that are susceptible to be involved in the pathogenesis of NAFLD and     identify the potential signaling pathways responsible for the progression of the disease.   "
228330|NCT00844805|"     The primary objective of this study was to assess the proportion of participants in the     infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of     participants with moderate-to-severe active axial spondyloarthritis and disease duration of     ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission     criteria.   "
228331|NCT00844818|"     The purpose of the study is to find better ways to help parents quit smoking, thus improving     their own health, the health of their children, and the health of other family members. This     study tested the feasibility and acceptability of enrolling parents into a telephone quitline     during postpartum hospitalization. Half of the parents in the study received quit smoking     assistance (intervention group), and half of the parents did not (control group). The     percentage of parental smokers who are enrolled in quit smoking programs by the study     follow-up will be greater in the intervention group than in the control group.   "
228332|NCT00844831|"     Patients with constipation often have bloating and abdominal distension. It is unclear if     this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce     small bowel and colon bacteria colonization, a change in the balance of stool microorganisms,     and improve the symptoms of dyspepsia and constipation.   "
228333|NCT00844844|"     The purpose of this study is to determine whether eculizumab is safe and effective in the     treatment of adolescent patients with plasma therapy-resistant Atypical Hemolytic-Uremic     Syndrome (aHUS).   "
228334|NCT00844857|"     The main goal of this study is to help answer the following research question(s) and not to     treat the child's illness.        -  Can this study drug make children with bipolar depression feel better?        -  Does this study drug work better than a placebo (sugar pill)?        -  Does this study drug cause side effects in children who take it?        -  Is this drug safe to use in children? (The study drug is a mixture of olanzapine and          fluoxetine)   "
228335|NCT00844870|"     After 4 weeks of training the hypothesis that the more natural training program would yield     greater functional changes was proven correct.   "
228336|NCT00844883|"     This study will combine two therapies to treat patients with unresectable hepatocellular     carcinoma; sorafenib, and drug eluting beads delivered intra-arterially. The purpose of the     study is to establish the safety and the effectiveness of the combination therapy. The     investigators hypothesize that the combination of the two therapies will not result in     greater toxicities to patients than that expected for either therapy given alone.   "
228344|NCT00844987|"     The main aim of the study is a comparison of serum and plasma concentration of VEGF (Vascular     Endothelial Growth Factor), HGF (Hepatocyte Growth Factor) and PDGF (Platelet Derived Growth     Factor) with markers of myocardial injury as troponin I, hsCRP, CK-MB and NT-proBNP assessed     in patients with first episode of acute coronary syndrome (ACS) in their lives and the     estimation of assumed value of VEGF, HGF and PDGF in prognosis of cardiovascular     complications at 3 months follow up especially with respect to myocardial infarction (MI),     exacerbation of angina, reintervention (PTCA,CABG), symptoms of heart failure, stroke,     rehospitalization due to cardiovascular reasons and death. The dynamics of changes in serum     and plasma concentration of growth factors in comparison with values of myocardial injury     markers will be checked. For the realization of the purpose of the study biochemical     measurements will be performed twice i.e. just after admission to hospital and 24h later.     Area of a myocardial injury will be estimated by echocardiography examination.   "
228551|NCT00847496|"     • To determine if AWBAT, used in treating partial-thickness burns, would provide better     healing, pain control, control of infection, shorter length of hospital stay, lower costs,     and improved scarring and long term recovery when compared to Biobrane®.   "
228337|NCT00844896|"     The objectives of this study are to test and validate a simple, feasible intervention to     reduce pediatric burn traumatic stress in 0-5 year old children and their parents.      We have refined and implemented an early post-burn psychosocial assessment and intervention     for stress reduction for young children and their parents based on the DEF Protocol     (Distress, Emotional Support, Family) from NCTSN's 'Pediatric Medical Toolkit for Health Care     Providers,' and a burn specific version of the COPE (Creating Opportunities for Parent     Empowerment)intervention.      It is hypothesized that the combined DEF + COPE Intervention will be simple to implement and     use under both experimental and real world conditions. The proof of the latter hypothesis     will be that staff at Shriners Hospitals for Children-Boston will willingly incorporate it     into routine care by the end of the project.      We will evaluate, using an RCT design, the DEF + COPE Intervention by comparing outcomes for     subjects who are randomly assigned to receive it with outcomes for subjects who are assigned     to receive the DEF Intervention only.      It is hypothesized that children in the DEF + COPE Intervention Group will show significantly     greater decreases over time in pain and anxiety ratings, heart rate, PTSD total symptom     scores and physiological symptom scores (such as heart rate and heart rate variability from     baseline to follow up) than will children in the DEF-only group. Similarly, it is     hypothesized that parents assigned to the DEF + COPE group will show significantly decreased     scores on the Stanford PTSD measure.   "
228338|NCT00844909|"     The purpose of this study is to evaluate the safety, tolerability and how the body affects     the drug CNTO 136 in healthy Japanese and Caucasian volunteers.   "
228339|NCT00844922|"     Patients who participated in the previous trial 28130, who were eligible, were entered into     this trial. Patients who were randomized to placebo in the previous trial 28130 continued on     placebo while patients who were randomized to Org 34517 (SCH 900636), regardless of dose,     were titrated to 900 mg Org 34517. Patients in this trial took their study medication for 2     weeks in order to study the safety and tolerability of Org 34517.   "
228369|NCT00845312|"     Pneumonia is a major cause of mortality and morbidity. A large body of evidence concerning     the mortality risk factors in elderly patients with pneumonia has been reported; however,     less is known about causes of mortality in patients of sixty and less. We noted a relatively     substantial rate of short term mortality in this group of patients that were admitted to our     institution. Therefore, we aimed to estimate the mortality rate and to identify risk factors     for mortality among patients of sixty years old and less that were admitted with community     acquired pneumonia.   "
228597|NCT00848107|"     This open label extension trial will allow ongoing treatment of subjects who participated in     the randomized controlled trials, and will provide long term information about the safety of     treprostinil diethanolamine SR in subjects with SSc and digital ulcers.   "
228340|NCT00844935|"     This research proposal has two main objectives. The first is to increase understanding of the     underlying physiological interactions that occur between the cardiovascular, pulmonary, and     ANS during transition between positive pressure mechanical ventilation (MV) and spontaneous     breathing. The second is to determine if heart rate variability, (HRV) a reflection of     autonomic nervous system (ANS) activity, and autonomic information flow (AIF), a set of     nonlinear measures derived from HRV, both measured in the intensive care unit (ICU) can     predict patient outcomes including successful weaning and in-hospital recovery time after an     episode of cardiopulmonary compromise requiring MV.      Hypothesis 1. Transitions between mechanically supported ventilation and spontaneous     breathing will disturb cardiovascular synchrony, altering the relationship of HRV, AIF,     respiratory rate, and blood pressure;      Hypothesis 2. More normal HRV and AIF values, measured during baseline MV and sedation     awakening (a period immediately prior to SBT when sedative medications are discontinued) will     be associated with easier weaning, and shorter intensive care unit (ICU) and hospital lengths     of stay; more abnormal measurements will be associated with longer lengths of stay;      Hypothesis 3. AIF is a more sensitive predictor of successful weaning from MV than HRV.   "
228341|NCT00844948|"     This Phase II SBIR study will replicate pilot study methods establishing computer-automated     methods for assessing depression severity using interactive voice response system technology     and demonstrating feasibility of obtaining measures of depression severity and treatment     response through vocal acoustic analysis of speech samples obtained over the telephone. The     study will automate vocal acoustic analysis methods, evaluate applicability to other patient     populations (non-English speakers, children/young adult, and geriatric), and further develop     multivariate acoustic models to enhance biomarker sensitivity to treatment response and     prediction of the response likelihood for individual patients.   "
228342|NCT00844961|"     The study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a     gastroenterological clinic. The recruitment will be consecutive with all patients receiving     the diagnosis being offered to participate. After recruitment and 3 week baseline measure of     IBS symptoms they will be randomised to either 10 weeks of internet delivered CBT or waiting     list. After treatment IBS-symptoms are measured again to assess treatment effectiveness. All     patients on waiting list are offered the same treatment as patients randomised to treatment.      All patients are assessed 12 months after completion of treatment.      Patients in treatment condition are hypothesized to experience significant reduction IBS     symptoms and quality of life compared to patients on waiting list.   "
228343|NCT00844974|"     The purpose of this research study is to learn more about cognitive deficits in people with     certain mood disorders. The mood disorders are Major Depressive Disorder (MDD) and Bipolar     disorder, depressed type.      Cognitive deficits are problems with things like thinking and memory. People with cognitive     deficits may have problems concentrating and paying attention. When talking, they may have     trouble recalling a word they want to say. They may think slowly and have problems     remembering things. These deficits can affect an individual's ability to work and function     socially. Cognitive deficits that occur with depression may increase the risk of a relapse of     major depressive disorder.      We want to study the course of cognitive impairment in subjects as they are receiving     treatment for their depression. We want to find out if their cognitive deficits get better,     worse, or stay the same.      We also want to learn more about a stress hormone called cortisol that is produced in the     body. We want to study the relationship between cortisol and cognitive impairment. Recent     research has shown that cognitive impairment may be more severe in people who have high     levels of cortisol in their blood.      We will also measure the levels of a protein in your blood called brain-derived neurotrophic     factor (BDNF). BDNF helps the growth of new brain cells. It appears that the growth of new     brain cells lessens when people are depressed. Treatment with antidepressant medications may     cause BDNF levels to increase and return to normal. We are interested in studying the     relationship between BDNF levels and cognitive impairment throughout treatment.   "
228356|NCT00845143|"     The purpose of this study is to assess the correlation of the predicted post-operative lung     function with the observed post-operative lung function (FEV1 and DLCO) in patients who     underwent surgical resection (FEV1 = Forced expiratory volume in 1-second. DLCO = Diffusion     capacity for carbon monoxide. ppo = predicted postoperative.)and versus the gold standard     QRRVP (Quantitative Radionuclide Study of Regional Lung Ventilation and Perfusion)   "
228346|NCT00845013|"     The purpose of this study is to describe the epidemiology of pulmonary hypertension in     individuals with HIV infection and to investigate its pathogenesis. We propose to conduct a     prospective observational cohort study to determine the association between highly active     antiretroviral therapy (HAART) and viral suppression in HIV-infected patients who have been     identified to have pre-clinical pulmonary hypertension (Aim 1). In addition, we will     investigate the mechanistic role of the HIV-1 Nef protein and HHV-8 infection in the     development and progression of pulmonary hypertension in individuals with HIV (Aim 2). We     will also investigate endothelial function in HIV-infected patients with pulmonary     hypertension (Aim 3).   "
228347|NCT00845026|"     This study will assess time to discontinuation due to lack of tolerability among patients     with schizophrenia receiving LY2140023, given orally twice daily for 24 weeks, versus those     on atypical antipsychotic standard-of-care treatment. Lack of tolerability is defined as     discontinuation due to adverse events (AEs). Patients who complete the active treatment phase     will be eligible to continue to an optional 28 weeks of treatment extension phase. This     extension phase will assess key safety and efficacy measures.   "
228348|NCT00845039|"     The purpose of this study is to determine the value of adding IMC-A12 to irinotecan and     cetuximab in patients with metastatic colorectal cancer.   "
228370|NCT00845325|"     To objectively and subjectively assess two modes of commonly employed rehabilitation and     confirm a superior method to treat patients following carpal tunnel release.      One of the problems following carpal tunnel release (CTR) for carpal tunnel syndrome, and all     hand surgeries, is the debilitation in the postoperative period. This relates to muscle     atrophy and joint stiffness due to immobilization or relative inactivity in the postoperative     period. Specifically, patients suffer increased days off from work, lost wages, and     difficulties with activities of daily living affecting the patient and society at large. CTR     is a very common procedure in hand surgery making it easy to study and important to optimize     the postoperative care.   "
228349|NCT00845052|"     Background: The occurrence of medical errors and their deleterious effects on quality of care     delivered are widely recognized phenomena in healthcare today. This has spurned an aggressive     nationwide campaign to improve the quality of care all hospitals throughout the country.     Currently, there are numerous reports of quality improvement initiatives across medical     centers in the United States. However, a review of the literature failed to identify any     publications regarding targeted resident/housestaff involvement in hospital quality     improvement and safety related activities.      Purpose: To investigate and track housestaff attitudes on patient care, patient safety,     communication and overall quality within the institution.      Objective: To investigate, analyze and publish the results of this prospective study. The     information obtained will help us and others understand whether proactive attempts to change     housestaff culture can indeed change attitudes towards the better with regards to patient     care and safety. It is assumed that improved attitudes ultimately translates into improved     care and safety.      Methods: Each residency coordinator in each clinical department will be asked to distribute a     survey, which has already been validated for this type of investigation, to each resident in     the respective program (see attachment).      The Vice-President of Medical Affairs will provide a cover letter to help with the process.     After a week, a reminder will be distributed by the coordinators to each resident asking them     to fill out the survey. The surveys will be filled out anonymously. However, each participant     will be asked to note their sex, department and year of postgraduate training. This process     will be repeated every eight months until June of 2010. The Housestaff Quality council (HQC)     has already distributed and collected this survey. The results of those surveys will be used     in a retrospective part of this study. The results of (HQC) survey will be used to establish     a baseline of the housestaff attitudes at the New York Presbyterian Hospital-Weill Cornell.      Data will be stored on a password protected computer. The Institutional Review Board (IRB),     Office of Human Research Protection and Food and Drug Administration and all appropriate     federal oversight agencies may have access to those files.   "
228350|NCT00845065|"     Based on previous experience with peginterferon alfa-2b/ribavirin in combination with     boceprevir, the combination with peginterferon alfa-      2a/ribavirin and boceprevir is expected to be safe and well tolerated. Given the wide     utilization of both peginterferons and the clear benefit of the      addition of boceprevir to peginterferon alfa-2b/ribavirin, it is important to demonstrate the     safety and efficacy of boceprevir in combination with      peginterferon alfa-2a/ribavirin.   "
228351|NCT00845078|"     This study examines the aesthetic outcomes of breast reconstruction after mastectomy for     breast cancer in patients who require post-mastectomy radiation treatment. Patients will     undergo autologous tissue breast reconstruction either in immediate fashion, prior to     radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are     acceptable and are practiced clinically. this will be an observational prospective cohort     study.      The investigators hypothesize that immediate autologous reconstruction patients who undergo     subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom     reconstruction is delayed until after radiation, with the additional benefit of avoiding the     psychological side effects of breast amputation.   "
228352|NCT00845091|"     The current research study proposes to examine participants with implantable cardioverter     defibrillators (ICD) who are randomly assigned to either an exercise training program     intervention or a heart healthy education program intervention. We will look at changes in     the functioning of the autonomic nervous system over time and between intervention groups. We     are also going to be looking at changes in frequencies of the ICD participants' heart     arrhythmias and ICD therapies (e.g., pacing, shock).; as well as, changes in exercise     tolerance, psychological well-being, and quality of life.   "
228353|NCT00845104|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine phosphate, work in different ways     to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or carry cancer-killing substances to them. Giving     fludarabine phosphate together with rituximab and bevacizumab may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving fludarabine phosphate together with     rituximab and bevacizumab works in treating patients with B-cell chronic lymphocytic leukemia     that has relapsed or not responded to treatment.   "
228354|NCT00845117|"     The purpose of this study is to determine whether cultivated stem cell transplantation is     effective for the treatment of patients wtih corneal stem cell deficiency.   "
228355|NCT00845130|"     Oxidative stress has been implicated in the development and complications of diabetes.     Hyperglycemia and insulin resistance or insufficiency in diabetes can cause oxidative stress     by excessive reactive oxygen species and can increase damage and alter antioxidant status in     nerve cells. Antioxidant defense mechanisms protect against damage or restore oxidative     damage. Glutathione, a powerful antioxidant plays a key role in the first line of antioxidant     defense and seems to be a sensitive indicator of oxidative stress in various diseases such as     diabetes. Glutathione functions in the regeneration of vitamin C which is another crucial     antioxidant. Both hyperglycemia and insulin insufficiency inhibit uptake of vitamin C. The     brain contains measurable amounts of glutathione that contribute to the antioxidant pool in     the brain and guards against disease processes that are caused by oxidative stress. Since the     brain is the most highly oxidative organ in the body and highly susceptible to oxidative     stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain     through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C     will be studied.   "
228357|NCT00845156|"     Subjects will be screened with a 2 hour oral glucose tolerance test. After this screening     visit, their insulin resistance will be measured. Subjects will then be given either alpha     lipoic acid (antioxidant) or placebo for 6 weeks. The insulin resistance test will be     repeated after the 6 weeks. We believe these studies will confirm the beneficial effect of     alpha lipoic acid on insulin sensitivity.   "
228358|NCT00845169|"     Exposure to air pollution has been linked to increased cardiorespiratory morbidity and     mortality. The exact component of air pollution that mediates this effect is unknown, but the     link is strongest for fine combustion derived particulate matter derived from traffic     sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs     vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these     detrimental vascular is unclear, but is thought to be via oxidative stress and altered     bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of     endogenous nitric oxide synthase isoforms (NO) in the adverse vascular responses observed     following exposure to diesel exhaust.   "
228371|NCT00845338|"     The objective of this study is to explore the effects of darifenacin in patients with     multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and     tolerability of darifenacin are already well established in idiopathic detrusor overactivity.     Patients with multiple sclerosis and neurogenic detrusor overactivity without     detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.   "
228359|NCT00845182|"     Pioglitazone, a drug used in treatment of type 2 diabetes has been shown to improve insulin     sensitivity in skeletal muscle, liver, and fat cells. Despite the beneficial effects of     pioglitazone to improve insulin sensitivity and reduce cardiovascular disease in high risk     type 2 diabetic patients, weight gain has been a limiting factor. Exenatide, another agent     used for treatment of T2DM, improves glycemic control and promotes moderate weight loss. In     this proposal we will examine the effect of combination therapy with pioglitazone plus     exenatide on body weight, fat topography, beta cell function, glycemic control, and plasma     lipid levels in subjects with type 2 diabetes mellitus compared to treatment with each drug     separately. Assessment of beta cell function will be performed by measuring the maximal     insulin secretory capacity using a maximal hyperglycemic stimulus combined with an     intravenous arginine stimulus.   "
228360|NCT00845195|"     The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with     Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal     Spray for the treatment of seasonal allergic rhinitis.   "
228361|NCT00845208|"     Relapse is the most serious problem in alcoholism treatment. The overall aim of the present     study was to determine if a treatment directed at changing the patient's social network, from     one that reinforces drinking behavior to one that reinforces sobriety, can create the     conditions necessary for long-term treatment success. In addition, we intended to determine     if explicit reinforcement for this change of social network (Contingency Management or ContM)     would be more effective than the same network support intervention without contingent     reinforcement for change.   "
228362|NCT00845221|"     It is a phase 4 study, not randomised and multicentric. Within 2 months after the diagnosis,     the patients daily receive imatinib by oral way during at least 1 year (260mg/m² once a day),     i.e. until the cytogenetic analysis.      Beyond 1 year of treatment, if a haematological relapse or a loss of the cytogenetic response     is observed, the nature of the treatment suggested to the patient is left with the     appreciation of the investigator.      Later on, discontinuation of imatinib is discussed if a molecular remission (negative RT-PCR)     is obtained and maintained for at least 2 years.   "
228363|NCT00845234|"     An implantable cardioverter defibrillator (ICD) administers a shock to terminate potentially     life-threatening cardiac arrhythmias. The device saves lives, but presents psychological     challenges for patients. At present, there is a paucity of brief interventions for ICD     patients designed for administration in a clinic setting that considers issues of cost, time,     and available resources. The present study examined the impact of a brief cognitive     behavioral (CBT) educational intervention on primary endpoints of patient acceptance and     quality of life and secondary endpoints of depression and anxiety. It was hypothesized that     the intervention would result in significant improvements primary and secondary endpoints for     participants in the intervention group.   "
228364|NCT00845247|"     Introduction: Case management (CM) has been proposed as a method for optimizing the course of     treatment for complicated cancer patients. However evidence of the effect of CM is limited     and methodologically rigorous research is needed.      Aim: To analyze effects of Nurse CM in complicated cancer care.      Methods: The study is designed as a two-arm randomized controlled trial (RCT) including     approximately 280 colorectal cancer patients.      Intervention group patients will be offered usual medical treatment plus supportive     intervention from a case manager. Control group patients will receive usual medical and     supportive treatment.      The intervention: Case managers are registered nurses and possess thorough knowledge of     cancer treatment and pathways. Core intervention elements: Planned and ad hoc personal and     telephone contacts, surveillance of care pathways, coordination and dissemination of care     plan (including transfer of patient-specific information to other departments and general     practice).      Primary outcomes: Patient evaluations of care pathways and Quality of Life     (questionnaires).      Secondary outcomes: Use of health care services and care process measures (The National     Health Insurance Service Registry and The National Patient Registry; and GPs' evaluations of     continuity of care (questionnaire).      Schedule:        -  Case management used to optimize cancer care pathways: A systematic Review has been          published in BMC Health Services Research.        -  The CM manual has been written. Questionnaires are under development and pilot testing.        -  Two case managers have been appointed 1. January 2009.        -  After training and pilot testing of the intervention the RCT will begin in March 2009.          Inclusion period is 12 months.   "
228365|NCT00845260|"     Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated,     often chronic psychiatric disorder. The are effective pharmacological as well as     psychological treatments for PD/A. Because of the lack of availability of the most effective     psychological treatment, cognitive behavior therapy (CBT), self-help based CBT treatments     have been developed. One of those are Internet-based CBT. The aim of this study is to compare     the effectiveness of Internet and group CBT for PD/A in a regular psychiatric setting. 113     patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks).     The main outcome measure is the Panic Disorder Severity Scale(PDSS). The study hypothesis is     that treatments will show equal effectiveness.   "
228366|NCT00845273|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3) factors considered to affect the safety and/or     efficacy of this drug.   "
228367|NCT00845286|"     The purpose of the study is to determine the myocardial function and vascular adaptation     after strenuous exercise in association with genotype/polymorphisms. We aim to investigate     the effects of extreme endurance exercise on the cardiovascular system. Furthermore, the role     of the inflammatory response and adaptive mechanisms of the vasculature are examined.     Subclinical injuries to the myocardium and vascular wall are being investigated.   "
228368|NCT00845299|"     The purpose of this study is to determine the effect of artificial tears preserved with     Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety     of the L-PPDS in subjects with OH or OAG following treatment.   "
228372|NCT00845351|"     The objective of this pilot study is to establish the safety and tolerability of short-term     therapy with bexarotene in patient's with Cushing's disease, and study the clinical,     biochemical, and cellular effects of a preoperative five-day course of bexarotene in these     patients before undergoing transsphenoidal surgery.   "
228373|NCT00845364|"     Open-heart surgery causes injury of the heart muscle. Although this is usually mild,     temporary and reversible, if it is severe it can endanger life and require additional high     cost care. During surgery, techniques are used to protect the heart from injury, but these     remain imperfect. This study assesses the effect of facilitating sugar metabolism (a more     efficient fuel) by the heart muscle using the drug Perhexiline given before the operation.     This treatment has a sound experimental basis for improving outcome. If this improvement is     confirmed surgical results could be improved. The investigators will be studying heart     function, heart muscle energy stores and chemicals which quantify the amount of heart muscle     injury. The investigators' hypothesis is that Perhexiline will improve the protection of the     heart by decreasing damage that may occur during heart surgery.   "
228374|NCT00845377|"     Depression is one of the leading causes of emotional suffering in later life. It has been     estimated that 2-5% of community-dwelling elderly people suffer from major depression, but     according to recent studies, as much as 25 % have clinically significant depressive     symptoms.Typically, depressive symptoms in the elderly are treated solely with     antidepressants.      The aim of this project is to study the effects of a comprehensive psychosocial intervention     on the psychological well-being, quality of life and use of services in depressed elderly     people. In addition, the processes of intervention are studied from the perspective of the     participants as well as the service system. The research is conducted in collaboration with     the city of Espoo. The design of the study combines clinical trial with qualitative process     analysis.   "
228375|NCT00845390|"     This study will be a qualitative survey to understand the expectations of defibrillator     patients with regards to their device. It is unknown what ICD (implantable-cardioverter     defibrillator) patients understand about their device and its purpose, thus we will be     talking to them about their device. Also, we will be interested in studying their beliefs on     how the ICD impacts their life expectancy and quality of life.   "
228376|NCT00845403|"     This study aims to gain an understanding of the key components of the immune response to     hepatitis B present in cord blood of HBV infected mothers.   "
228377|NCT00845416|"     The goal of the proposed research is to establish the validity of a newborn screening method     for severe combined immunodeficiency (SCID). The assay to be used is developed on the basis     of PCR quantification of T-cell receptor excision circles (TRECs) that is absent in SCID     patients, thus correlating with the disease   "
228378|NCT00845429|"     Primary Objective:      To describe the immune response to a single administration of 2 formulations of the     investigational cell-based influenza vaccines in healthy adult subjects.      Secondary Objective:      To describe the safety following a single administration of 2 formulations of the     investigational cell-based influenza vaccines in healthy adult subjects.   "
228379|NCT00845442|"     People who had paralysis of the vocal cords are often prevented from breathing by this     problem because the cords will not open, and the patients have to wear a tracheostomy (neck     breathing tube) to bypass this airway obstruction. This study examines the effects of vocal     cord opening triggered by a pacemaker implanted over the chest wall. The device is connected     to a nerve taken from a muscle close to the larynx (voice box) and implanted into the     paralysed laryngeal muscle so it can reinnervate it. When this process is complete after a     few weeks, the stimulator is turned on and the level of vocal cord opening is assessed.     Airway improvement is checked by pulmonary function tests and measurements of vocal cord     opening. The ultimate goal of the study is to lead to situations where patients with     bilateral vocal fold paralyses could get rid of the neck breathing tube to have less     complications, be more comfortable and socially acceptable.   "
228380|NCT00845455|"     Personality type as a predictor to develop depression and reduction in quality of life among     stroke survivals.   "
228381|NCT00845468|"     Diabetes mellitus is a major risk factor for the development of ischemic heart disease, and     patients with diabetes mellitus have a worse outcome following an acute myocardial infarction     than non-diabetic patients. Furthermore, abnormal glucose metabolism below the diagnostic     threshold of diabetes mellitus is also associated with increased risk of death compared to     patients with a normal glucose metabolism. The frequency of abnormal glucose metabolism in     acute myocardial infarction is high, and approximately 70% of myocardial infarction patients     have diabetes mellitus, newly diagnosed diabetes mellitus or impaired glucose tolerance,     leaving only 30% with normal glucose metabolism. The increased mortality among patients with     acute myocardial infarction and abnormal glucose metabolism seems mainly related to a higher     occurrence of congestive heart failure, suggesting that an abnormal glucose metabolism may     play an important role among others in endothelial dysfunction, infarct healing and overall     left ventricle function. This raises the question, whether patients with acute myocardial     infarction and abnormal glucose metabolism have increased frequency of micro- or     macrovascular disease or both.      Coronary flow velocity reserve reflects the patency of the epicardial coronary artery in     combination with vasodilator capacity of the microcirculation and may therefore offer a tool     for assessment of macro- and microcirculation.      This study will focus on the relation between coronary flow velocity reserve estimated by     transthoracal Doppler echocardiography and mortality, risk for heart failure and left     ventricle function after acute myocardial infarction stratified according to glycometabolic     state   "
228382|NCT00845481|"     The purpose of the study is to compare the anti-psoriatic effect of marketed products with     Daivobet® ointment in a plaque test   "
228383|NCT00845494|"     The purpose of the study is to determine if a behavioral knowledge based education     intervention will decrease medication transcription errors among professional nurses when     admitting elder patients to a hospital. The hypothesis is those professional nurses who     receive the behavioral-cognitive eduction medication taking intervention will have fewer     medication errors than those professional nurses who do not.   "
228384|NCT00835497|"     This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg     Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical     Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg     METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500     mg tablet) in healthy adult subjects administered under fasting conditions.   "
245851|NCT01067729|"     The purpose of this research study is to compare the rate of healing, the infection or     complication rate, pain perception and scarring from burn injuries using two types of burn     dressings.   "
228385|NCT00835510|"     To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine     hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in     the treatment of interdigital tinea pedis, and to show the superiority of the active     treatments over that of the placebo (vehicle).   "
228386|NCT00835523|"     The aim of the study is to explore the concept of GnRH-agonist triggering in combination with     elective cryopreservation of all 2PN oocytes at larger scale in a pragmatic clinical setting.     The question asked is: Does GnRH-agonist triggering and cryopreservation work, in terms of     efficacy and safety, when applied to a larger cohort of patients, and by a number of     different centres with different clinical routines.   "
228387|NCT00835536|"     The objective of this study is to compare the relative bioavailability of ribavirin 200 mg     tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA     Pharmaceuticals USA) with that of COPEGUS™ 200 mg tablets (Roche) in healthy, adult,     non-smoking, females (who are unable to become pregnant) under non-fasting conditions.   "
228388|NCT00835549|"     The objective of this study is to compare the relative bioavailability of cefdinir for oral     suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of     OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects     under non-fasting conditions.   "
228389|NCT00835562|"     Displaced four-part fractures are among the most severe injuries of the proximal humerus. The     optimal treatment is disputed and published data are inadequate for evidence-based decision     making.      The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and     non-surgical management, 2) compare the effect of primary hemiarthroplasty with both     osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus     impacted' and 'classical' four-part fracture patterns.      The investigators will conduct a randomised, multi-centre, clinical trial including patients     from ten national shoulder units within a two year period. Patients will be randomised to     non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients     will receive a standardised three-month rehabilitation program of supervised physiotherapy.     Patients will be followed at least one year and will be assessed blindly according to a     standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score,     and Short Form-36.   "
228390|NCT00835575|"     This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg     Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries,     Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally     Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc. following a single     oral dose (1 x 15 mg) in healthy adult subjects under fasting conditions.   "
228391|NCT00835588|"     The objective of this study is to compare the relative bioavailability of pantoprazole sodium     40 mg delayed-release tablets ( manufactured by TEVA Pharmaceuticals Industries, Ltd. and     distributed by TEVA Pharmaceuticals USA) with that of PROTONIX® 40 mg delayed-released     tablets (Wyeth-Ayerst) in Healthy, adult, non-smoking subjects under fasting conditions.   "
228409|NCT00845507|"     The purpose of this research study is to test the safety and efficacy (how well it works) of     exenatide as a treatment for weight gain associated with olanzapine in obese adults with     Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder      Exenatide has been approved by the FDA for the treatment of Type 2 diabetes.      It has not been approved for the treatment of weight gain associated with olanzapine in obese     adults with bipolar disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective     Disorder   "
228443|NCT00846079|"     Demonstrate the ability of muti-detector computed tomography to adequately perform stress     testing will result in a veritable one-stop shop of non-invasive cardiac imaging that is,     the ability to directly visualize heart arteries with high accuracy and to simultaniously     determine the hemodynamic significance of any blockages visualized.   "
228392|NCT00835601|"     This is a training study in healthy volunteers to characterize gains in lower-body resistive     strength and cardiovascular capacity with exercise on a Combined Countermeasure Device (CCD)     we have developed for the National Space Biomedical Research Institute. The CCD is a single     platform which contains interchangeable modules for cardiovascular stepping exercises and     lower body resistive exercises including squats, heel raises, abductor and adductor exercises     and knee extension and flexion. The platform has the capability to tilt, yaw and pitch, and     to translate in three dimensions in order to challenge the neurovestibular system. The     underlying goal of the project is to provide a compact and efficient exercise modality that     will prevent deterioration of the cardiovascular and musculoskeletal systems, and the     neurovestibular system, in long-duration spaceflights. The goal of the current study is     simply to test the hypothesis that in healthy volunteers, the exercise prescription proposed     for the device will improve strength and VO2 max. Subjects are tested for lower body     resistive strength and V02max at baseline, then are trained for 12 weeks, and tested again at     followup to test for a change. 36 subjects, allowing for a 20% attrition rate, allows     sufficient power to detect 95% percent confidence intervals in the changes in the strength     and V02max measures of roughly 10-20%. If we observe gains in these indices which are similar     to those reported in the literature for simultaneous cardiovascular and resistive strength     protocols, then we believe that there is sufficient evidence to test CCD in a bedrest model     of long-duration spaceflight.   "
228393|NCT00835614|"     The objective of this study is to compare the relative bioavailability of cefprozil for oral     suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension     250 mg/5 mL (Bristol-Myers Squibb) in healthy, non-smoking adults under fasting conditions.   "
228394|NCT00835627|"     The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or     focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES)     or combined treatment (CBT-ip + sertraline) will report fewer nonepileptic seizures (NES)     compared to patients who receive community care / treatment as usual (TAU). The purpose of     this study is to provide pilot testing and data to inform the future multicenter randomized     controlled trial based on the hypothesis.   "
228595|NCT00848081|"     The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to     men who are currently taking a medication called an alpha blocker for the treatment of benign     prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that     the bladder is not completely emptied after urination).   "
228395|NCT00835640|"     This study will compare the relative bioavailability (rate and extent of absorption) of 180     mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd.     with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral     dose (1 x 180 mg tablet) in healthy adult volunteers under fed conditions.   "
228396|NCT00835653|"     Observational study of the efficacy of median nerve blocks performed using echographic     guidance in patients presenting with or without carpal tunnel syndrome.   "
228397|NCT00835666|"     The objective of this study is to compare the relative bioavailability of finasteride 5 mg     tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of PROSCAR® 5 mg     tablets (Merck) in healthy, adult, non-smoking, male subjects under fasting conditions.   "
228398|NCT00835679|"     This phase 0 trial is studying whether 2 weeks of cetuximab and dasatinib will change tumor     cells in patients with colorectal cancer and liver metastases that can be removed by surgery.     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Dasatinib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth.   "
228399|NCT00835692|"     This study will compare the relative bioavailability (rate and extent of absorption) of 500     mg Clarithromycin Tablets with that of 500 mg BIAXIN® Tablets following a single oral dose (1     x 500 mg tablet) in healthy adult subjects under fasting conditions.   "
228400|NCT00835705|"     The objective of this study is to compare the rate and extent of absorption of     amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin®     (reference) administered as 1 x 400 mg-57 mg chewable tablet under fasting conditions.   "
228401|NCT00835718|"     A study in patients with alcohol dependence to see if MK0594 is safe and effective in     maintaining absence of heavy drinking over a 12-week treatment period.   "
228402|NCT00835731|"     The purpose of this study is to compare the dilatory effect of 400 mcg of buccally     administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation     and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.   "
228403|NCT00835744|"     The purpose of the present study is to analyse prospectively if highly purified hMG compared     with increased dose of clomiphene citrate has different outcomes in folliculogenesis in     ovulation induction cycles.   "
228404|NCT00835757|"     This study aims to validate magnetic resonance imaging and diffusion tensor imaging (MRI/     DTI) analysis as a non-invasive method for the assessment of myelinated nerve fibers loss in     diabetic peripheral neuropathy.   "
228405|NCT00835770|"     The primary objective of this study is to evaluate the long-term safety profile of BG00012     (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term     efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further     the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic     resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301     (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on     health economics assessments and the visual function test.   "
228406|NCT00835783|"     The overall aim is to validate the current use of FDG PET/CT for the diagnosis of infection     and inflammation and examine the usefulness of PET/CT applying also other tracers.      The results should allow us to confirm our primary hypothesis: FDG-PET/CT is better than     established methods to confirm or exclude the diagnosis of infection/inflammation.   "
228407|NCT00835796|"     The objective of this study is to compare the relative bioavailability of finasteride 5 mg     tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of PROSCAR® 5 mg     tablets (Merck) in healthy, adult, non-smoking, male subjects under non-fasting conditions.   "
228408|NCT00835809|"     Biomarkers have an interest in clinic diagnostic ,therapeutic and prognosis in     pathophysiologic situation including cardiovascular.But interest of biomarkers in diagnostic     care of severe acute respiratory insufficiency remains to clear.      We propose to determine the more relevant marker combination in this case.   "
228410|NCT00845533|"     This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the     antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children.     Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We     hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and     this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this     open-label trial in Burkina Faso. The target population includes residents, aged 6 months to     10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms     suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection     criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic     sampling for DP will occur on selected follow-up days.   "
228411|NCT00845546|"     The objective of this study was to compare the single-dose relative bioavailability of     Ranbaxy and Schering (Claritin-D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate     Extended-Release Tablets, in a fully replicated design, under fed conditions.   "
228412|NCT00845559|"     The primary aim of this study is to evaluate the effect of exenatide on daily glycemic     excursions obtained by continuous glucose monitoring system (CGMS). The CGMS summary     parameters that we are most interested in include:        -  The percent of glucose values above 140 mg/dl and/or AUC of glucose values above 140          mg/dl        -  AUC of glucose values over 100 mg/dl during three days        -  Maximal meal-related glucose excursions        -  Three-day mean glucose (including low readings - below 100 mg/dl)      Secondary Study Endpoints:      Secondary endpoints will include:        -  glucose tolerance status as assessed by OGTT        -  Vascular function scores as assessed by PAT, FMD and step test.        -  Biochemical markers of vascular health, including inflammatory markers, markers of          oxidative stress and microalbuminuria.        -  Changes in BMI   "
228430|NCT00845793|"     This protocol is intended to test whether a focused nutritional intervention in hospitalized     patients with type 2 diabetes can have an impact on long term eating habits, physical     activity and anthropometric parameters.      The rational is to use the food tray as a means of conveying simple and practical nutritonal     and behavioral messages.   "
228431|NCT00845806|"     The purpose of this study is to determine brain function in reading arabic diacritics.   "
228413|NCT00845572|"     This study will establish a bi-weekly Consta Club. Participants will begin taking Risperdal     Consta after being recommended by their treating physician. As a part of the Consta Club     attendees will receive their injection of Risperdal Consta and be educated about important     mental health issues. Interviews with study participants will be completed every three months     to determine the effectiveness of the change to Risperdal Consta and the bi-weekly group. The     overall hypothesis is that the individuals in Consta Club will have a decrease in walk-in     visits, emergency procedures and hospitalizations. It is also believed that individuals in     Consta Club will have fewer symptoms and better levels of functioning.   "
228414|NCT00845585|"     The study intends to compare commonly used PTFE grafts with the biologic ovine graft     Ominiflow II for below-knee bypass surgery in patients with peripheral artery occlusive     disease with no autologous vein graft available. The hypothesis of this randomized trial is     that that Omniflow II does not have a higher patency than PTFE over 36 months (one-sided     test). An interim analysis will be performed at 18   "
228415|NCT00845598|"     The purpose of this study is to see how a combination spray of azelastine and fluticasone     (antihistamine and steroid) compares with a steroid nasal spray (fluticasone) alone in     allergic rhinitis i.e. does azelastine permit the use of lesser steroid dose (steroid sparing     effect) to achieve the same benefit.   "
228416|NCT00845611|"     The purpose of this study it to evaluate the safety and immune response of peptides (URLC10)     emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent     gastric cancer.   "
228417|NCT00845624|"     The purpose of this study is to determine if there is a relationship between time spent out     the targeted oxygen saturation range in preterm infants is associated with long-term outcomes     such as Retinopathy of Prematurity.   "
228418|NCT00845637|"     The purpose of this study was to assess the effect of eggplant extract capsules on the lipid     profile of healthy individuals after an oral lipid overload test in a randomized,     double-blind, placebo-controlled clinical trial.   "
228419|NCT00845650|"     The purpose of this study is to:        -  evaluate the safety profile of a single intravenous administration of AIGIV (containing          either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as compared with either 90 mg/kg,          180 mg/kg or 360 mg/kg total IgG, GAMUNEX(R)(immune globulin intravenous (human) 10%          caprylate/chromatography purified). GAMUNEX is a trademark of Talecris Biotherapeutics.        -  evaluate the pharmacokinetic (PK) profile of a single intravenous administration of          AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as measured by          lethal toxin neutralizing antibody (TNA).   "
228420|NCT00845663|"     To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x     200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an     auto-injection device (test).   "
228421|NCT00845676|"     This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV)     infection during the first 6 months after acquiring HCV among people who already have     pre-existing HIV infection will result in improved responses to HCV therapy with a shorter     duration of infection.   "
228422|NCT00845689|"     Liver damage as a consequnce of ischemia (I) and reperfusion (R) is known to harm the liver     and could hence be a critical factor of the postoperative outcome of patients undergoing     liver surgery. In order to protect the liver from ischemic damage following interventions     such as the Pringle Maneuver, preconditioning has been successfully applied in various animal     models as well as in humans. Since ischemia inevitably leads to cell hypoxia and subsequnet     release of endogenuous metabolites, the investigators hypothesize that instead of brief     periods of ischemia, the exogenuous infusion of purine analogues may also protect against     subsequent prolonged periods of ischemia. Moreover, after reperfusion, the antiinflamamtory     action of purine ananlogue infusion can further attenuated liver damage.   "
228423|NCT00845702|"     The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA     in patients suffering from renal arterial disease.   "
228424|NCT00845715|"     The purpose of this study is to investigate whether there is a difference in the quality of     life, ability to return to functioning (back to everyday life), the amount of experienced     pain in patients who immediately move their shoulder versus patient who delay moving their     shoulder after arthroscopic rotator cuff repair. We are also interested in whether there is a     difference in the healing rates between these two groups.   "
228425|NCT00845728|"     This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks   "
228428|NCT00845767|"     Exposure to air pollution has been linked to increased cardiorespiratory morbidity and     mortality. The exact component of air pollution that mediates this effect is unknown, but the     link is strongest for fine combustion derived particulate matter derived from traffic     sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs     vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these     detrimental vascular is unclear, but is thought to be via oxidative stress and altered     bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of     endogenous nitric oxide (NO) in the adverse vascular responses observed following exposure to     diesel exhaust.   "
228429|NCT00845780|"     Amiodarone is considered to be the most effective antiarrhythmic drug in the prevention of     persistent atrial fibrillation. It can however cause many adverse events, both cardiac and     non-cardiac. Long-term maintenance of sinus rhythm after cardioversion is difficult     especially because of high recurrence rates during the first month after cardioversion.     Duration of atrial fibrillation, type of underlying disease, left ventricular function, left     atrial size and age are associated with maintaining sinus rhythm. Early recurrence of atrial     fibrillation may be related to a highly arrhythmogenic period due to recovery from electrical     remodelling. Late recurrences may be related to other triggers than recovery from electrical     remodelling. In this study the investigators want to investigate the effect of amiodarone     withdrawal on the occurrence of late relapses of persistent atrial fibrillation. Furthermore,     the investigators want to investigate the effect of amiodarone withdrawal on the occurrence     of amiodarone related adverse events as well as adverse events related to atrial fibrillation     or underlying heart disease. The investigators also want to investigate which patients     characteristics are and potential triggers have a prognostic value in the occurence of late     relapses after amiodarone withdrawal.   "
228433|NCT00845832|"     This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in     combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose     of methotrexate. In Part 1 of the study, patients will be randomized to receive either     MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending     doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm).     In Part 2, additional pati ents will be randomized to one of 2 groups to receive MabThera     0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8     and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.      All patients will then be eligible to receive extension treatment withRoActemra every 4     weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is     <100 individuals.   "
228434|NCT00845962|"     The purpose of this study is to compare the efficacity and the readiness for discharge     between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia.   "
228435|NCT00845975|"     The purpose of this study is to determine if low level laser light therapy might help to     relieve tinnitus in adults.   "
228436|NCT00845988|"     The primary goal of this study is to investigate metabolic changes and maintaining efficacy     in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.   "
228437|NCT00846001|"     The purpose of the study is to compare survivability and efficacy of the patients with severe     ischemic heart failure after coronary artery bypass grafting alone and coronary artery bypass     grafting with single-step implantation of CRT system (CABG alone vs CABG + CRT )   "
228438|NCT00846014|"     The goal of this research is to use Helium-3 MRI to see the changes in airflow of the lungs     at different times of an attack. These three stages are immediately after the attack, 1 month     later and 4-6 months later.   "
228439|NCT00846027|"     This single-arm study assessed the efficacy and safety of first-line treatment with Avastin     (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in     patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel     150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment     cycle until disease progression, death, or withdrawal of consent.   "
228440|NCT00846040|"     Background:      - Popular weight loss strategies often involve reducing an individual's consumption of     carbohydrates or fat. However, no controlled study has been carried out to evaluate the     effects of reducing carbohydrate versus fat consumption while keeping the other nutrients at     standard levels to maintain an individual's weight. Researchers are interested in     investigating how different restrictions of carbohydrates or fats affect the many processes     involved in weight loss, including brain activity and blood and brain chemical composition.      Objectives:      - To determine the comparative effects of two controlled fat- or carbohydrate-restricted     diets and an outpatient weight loss program on blood and brain chemical composition, weight     loss (fat and lean body mass), and regional brain activity in lean and obese individuals.      Eligibility:      - Healthy individuals between 18 and 45 years of age who are either lean (body mass index     between 18.5 kg/m(2) and 25 kg/m(2)) or obese (body mass index above 30.0 kg/m(2), weight     less than 350 pounds) and are right-handed.      Design:        -  For obese participants, this study consists of four phases: an initial 2-day screening          visit followed by two separate in-patient visits and one set of 12-week outpatient          visits. For lean participants, this study consists of a scanning visit and a 2-day          screening visit that will require an overnight stay.        -  Lean participants        -  Participants will be screened with a medical history, physical examination, blood and          urine tests, and weight maintenance observations (food diaries and physical activity          monitors).        -  For the scanning visit, participants will receive balanced meals from the National          Institutes of Health to consume for 2 days before the visit. During the scanning visit,          participants will continue to eat the weight maintenance diet, complete questionnaires,          and have a series of imaging studies (including positron emission tomography and          magnetic resonance imaging tests) to evaluate brain response to food and other stimuli.        -  Obese participants        -  Participants will be screened with a medical history, physical examination, blood and          urine tests, and weight maintenance observations (food diaries and physical activity          monitors).        -  During the first inpatient visit, obese participants will eat a weight-maintenance diet          for 5 days to establish baseline measurements. Following the baseline diet, participants          will then be switched to either a reduced-fat or a reduced-carbohydrate diet for the          next 6 days. After the controlled diet, participants will have 3 days where they will be          permitted to select food as desired from a computerized vending machine system.          Participants will have frequent blood and other tests throughout this visit.        -  After a 10-week washout period, participants will return for a second inpatient visit in          which they will have the other (reduced-fat or reduced-carbohydrate) diet, with the same          tests and procedures as before.        -  After the second in-patient visit, participants will be assigned to a 12-week outpatient          weight loss program with the goal of achieving at least 5% weight loss. During this          program, participants will continue to have blood tests and imaging studies to evaluate          the effects of weight loss on metabolism, brain reward circuitry, and regional brain          activity.        -  Participants who are available for long-term followup will have yearly visits for the          next 5 years following the weight loss intervention.   "
228444|NCT00846092|"     Summary of Study Rationale Near-infrared light (NIR) via light-emitting diodes (LED)     treatment promotes retinal healing and improve visual function following high intensity laser     retinal injury by augmenting cellular energy metabolism, enhances mitochondrial function,     increases cytochrome C oxidase activity, stimulates antioxidant protective pathways, and     promotes cell survival. LED directly benefits injured neurons in the retina, the lateral     geniculate nucleus, and the visual cortex, where perception occurs. From a public health     perspective, a Light-Emitting Diode (LED) Array study is important to conduct because it has     been approved as a non-significant risk (NSR) device for treatment of eye disorders, it has a     low cost of treatment, and it may serve as an effective, non-invasive alternative or     adjunctive treatment to laser photocoagulation, the current standard of care for DME.      Study Objectives and Hypotheses        1. To determine the effects of short term (3 month) near-infrared light (NIR) therapy on          anatomic and functional abnormalities of diabetic macular edema as assessed by visual          acuity, optical coherence tomography, multifocal electroretinography (mERG) and fundus          bimicroscopy.        2. To assess safety of short term near-infrared light therapy in eyes with diabetic macular          edema.   "
228445|NCT00846105|"     The purpose of this study is to evaluate the efficacy of a novel PCR-based laboratory test     for rapid detection of MRSA carriers to prevent transmission of MRSA in the Belgian acute     care hospital setting.   "
228446|NCT00846118|"     The purpose of this study is to verify whether pitavastatin prevents from cardiovascular     events and improves the mortality in chronic hemodialysis patients with hypercholesteremia.   "
228447|NCT00846131|"     A research study to determine the safety, efficacy, and tolerability of Therasphere® (also     known as Y-90, or Y-90 Therasphere) combined with or without sorafenib (Nexavar®), in     patients with hepatocellular carcinoma (HCC, or liver cancer), awaiting liver     transplantation.   "
228462|NCT00846326|"     The investigators wish to evaluate the effects of decongestants like oxymetazoline and the     lessening of this effect with time called 'tolerance'. The investigators will demonstrate a     reversal of this tolerance with nasal steroids i.e. the investigators will show that nasal     steroids protect against tolerance. This will tell us more on how the investigators can make     this treatment effective and safe for patients suffering with allergic rhinitis.   "
228463|NCT00846339|"     Bupropion has different effects on D2 dopamine receptors according to genotype.   "
245852|NCT01067742|"     The purpose of this study is to define the natural history of Mucolipidosis Type IV and     identify potential clinical outcome measures.   "
228448|NCT00846144|"     In the CDs rat model, beta-cell dysfunction and pancreatic exocrine damage are triggered and     prevented by altering dietary Cu content suggesting a chronic and acute role for Cu. These     abnormalities become apparent when the CDs rats are exposed to high sucrose low copper diet,     triggering a vicious sequence of events: exocrine damage, recruitment of macrophages     expressing IL-1beta leading to oxidative stress and even more reduction in the activity of     Cu-dependent enzymes (chronic effect). When Cu levels are re-established (acute effect) they     may prevent the inhibitory effect of IL-1beta on insulin release and may restore the activity     of enzymes inhibited by IL-1beta. In this study we will identify humans with marginal Cu     status that may benefit from copper supplementation to normalize their GSIS. These patients     will be given a daily Cu supplement (3mg/d), or placebo for a period of 6 months. GSIS,     pancreatic dysfunction and biomarkers of marginal Cu status will be measured in different     blood components before and every 4 weeks during treatments or placebo.   "
228449|NCT00846157|"     Primary objective:        -  To compare the event free survival for 3years of R-CHOP plus Biocell Natural Killer Cell          to R-CHOP therapy with DLBCL patients.   "
228450|NCT00846170|"     Probiotics are defined as 'mono- or mixed cultures of live micro-organisms which, when     applied to animal or man, beneficially affect the host by improving the properties of the     indigenous flora'. Certain probiotics possess potent antibacterial and antiviral properties.     Probiotic antibacterial activity may derive from the direct secretion of bacteriocins, the     elaboration of proteases directed against bacterial toxins or through their ability to adhere     to epithelial cells and thus exclude pathogens. The antiviral properties of some probiotic     organisms, including the stimulation of interferon production, together with the     well-documented efficacy of certain probiotics in the therapy of rotavirus diarrhea suggests     the potential for a role for these agents in PI-IBS. The efficacy of some probiotics in     preferentially relieving 'gas-related' symptoms may be related to qualitative changes in the     colonic flora, as described earlier, or through the suppression of Small intestinal bacterial     overgrowth (SIBO) , as there are reports of efficacy of probiotics in SIBO.      The aim of the proposed study is to investigate whether the probiotic preparation co biotic     can change the composition of fecal bile acids, fatty acids and bacterial composition, and     whether such changes, if they occur, are correlated to a change in the symptoms of patients     with IBS.      Materials and methods:      Patients diagnosed as having IBS by the Rome III criteria will be included in the study.      Study subjects will be interviewed by a physician who will asses the diagnosis of IBS     according to the Rome III criteria. Subjects will sign an informed consent and fill an IBS     questionnaire and a health related quality of life questionnaire,      A fecal sample will be obtained      The subject will receive the probiotic product in a dose of 2 tablets/day, or a placebo     containing all the active ingredients in the probiotic capsule, besides the bacteria, for 4     weeks. They will then enter a washout period of 2 weeks in which they will not receive     anything, and then another 4 weeks in which they will receive the probiotic product in a dose     of 2 tablets/day, or a placebo. Patients will be randomized so that they will receive the     study drug for 4 weeks and the placebo for 4 weeks, in a double-blinded fashion. Thus each     patient will be his own control.   "
228451|NCT00846183|"     Local injury on two sights of endometrium are performed in 60 patients in their first IVF     cycle and implantation rate are compared with fresh cycles without local injury.   "
228452|NCT00846196|"     Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will     consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2     treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2),     and exit procedures.   "
228453|NCT00846209|"     Prior studies have documented a high prevalence of patients misunderstanding prescription     drug warning labels, placing them at risk for medication error.      We sought to evaluate the effectiveness of 'enhanced print' drug warnings to improve patient     comprehension beyond a current standard.A three-arm, controlled clinical trial was conducted.     Patients were assigned to receive 1) current standard drug warning labels on prescription     containers (standard), 2) 'enhanced' drug warnings with text rewritten in plain language     (enhanced text), or 3) enhanced language and icons developed with patient feedback (enhanced     text + icon).      Setting: Two academic and two community health primary care clinics in Chicago, IL and     Shreveport, LA.      Patients: 500 adult patients consecutively recruited at each clinic. Main Outcome Measure:     Rates of correct interpretation of nine drug warning labels as determined by a blinded panel     review of patients' verbatim responses.   "
228454|NCT00846222|"     The purpose of this study is evaluate the safety and feasibility of mild therapeutic     hypothermia (TH) during and 12 hours after primary percutaneous coronary intervention for     acute myocardial infarction complicated with shock   "
228455|NCT00846235|"     The aim of this study is evaluate the effect of three moisturising creams on Stratum corneum     (SC) hydratation and barrier function.   "
228505|NCT00846898|"     The aim of the study is to assess whether dietary supplementation of cinnamon (cinnamon     cassia) has the potential to improve HbA1c, blood pressure and serum lipid measurements in     patients with type 2 diabetes mellitus.   "
248251|NCT01104961|"     The goal of this study is to investigate the overall theory that the use of chemically     preserved solutions associated with contact lenses promotes an increase in bacterial     infection.   "
228456|NCT00846248|"     Chromium is an essential nutrient for the maintenance of normal glucose tolerance and its     deficiency causes insulin resistance. Chromium administration has also been shown in several     studies to lower glucose and insulin levels in patients with type 2 diabetes. Accordingly, we     propose to perform a placebo-controlled study of chromium picolinate administration in a     cohort of non-obese, non-diabetic, insulin resistant subjects. These subjects will be     randomized to 16 weeks of therapy with either 500 mcg twice a day of Chromium or placebo.   "
228457|NCT00846261|"     In this retrospective study, the investigators evaluated the clinical and functional results     of infected nonunion of the long bone with soft-tissue defects treated simultaneously with     Ilizarov technique combining open dressing change in 22 patients. The investigators wanted to     find out whether that the internal bone transport with external fixator combining open     dressing change is a valuable method to treatment for those patients with infected bone     nonunion and poor condition of the soft tissue such as sinus, skin defect.   "
228458|NCT00846274|"     To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1     study in healthy male subjects was designed   "
228459|NCT00846287|"     The purpose of this study is to determine efficacy of MR imaging with hyperpolarized helium-3     gas in COPD patients both before and after treatment.   "
228460|NCT00846300|"     This study examines a brief physician counseling intervention to improved medication     knowledge and compliance in family medicine patients who have diabetes, hypertension or high     cholesterol.   "
228461|NCT00846313|"     The purpose of this randomised intervention study is to investigate to what degree patients     with colorectal cancer benefit of dietary counselling regarding nutritional status, oncologic     treatment and quality of life.   "
228464|NCT00846352|"     This study will evaluate the outcomes of bronchoscopy in Bome Marrow Transplant (BMT)     patients who develop lung infiltrates suspicious for infections of the lungs. It will consist     of two groups, one group will receive bronchoscopy within thirty six hours of enrollment,     while the other group will receive bronchoscopy five days after enrollment. The purpose of     this study is to determine the ideal time for bronchoscopy in this group of patients.   "
228465|NCT00846365|"     The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil     combined with chlorthalidone, once daily (QD), in participants with moderate to severe     essential hypertension.   "
228466|NCT00846378|"     The size of a heart attack will be decreased by the use of timed balloon inflations to open     the blocked blood vessel.   "
228467|NCT00846391|"     A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.   "
228468|NCT00846404|"     This study is to look at the differences between people who have evidence of abnormal heart     relaxation (diastolic dysfunction) on sound wave pictures of the heart (an echocardiogram)     compared to those who do not. If you have abnormal relaxation, it can be a cause of shortness     of breath or can be present without knowing about it.      A condition known as oxidative stress mayb e associated with this abnormal relaxation. This     condition occurs when abnormal oxygen injures heart cells. We would like to learn if patients     with abnormal relaxation have increased oxidative stress.   "
228469|NCT00846417|"     In this study, we will compare the quality of life in veterans having ICD who attend the ICD     support groups to those who do not. We ask them to answer a set of quality of life     questionnaires at baseline and then at 3,6,9 and 12 month visits. These questionnaires would     be analyzed to assess if attending support groups made a difference. These results will be     compared to a similar study done at Emory University on non veterans.   "
228470|NCT00846430|"     Patients with neurofibromatosis type 1 (NF1) commonly develop non-cancerous tumors called     plexiform neurofibromas. These tumors can be defined as high-risk when they result in     severe pain, physical disability, organ dysfunction and/or become life-threatening.     Presently, there is no effective medical therapy to offer patients with high-risk plexiform     neurofibromas, and surgery does not provide lasting help. This study will evaluate the     effectiveness of two treatment combinations in patients with high-risk plexiform     neurofibromas.   "
228471|NCT00846443|"     The purpose of this study is to determine the recommended dose of pemetrexed and the maximum     tolerated dose of radiotherapy when using concurrent pemetrexed/cisplatin/radiotherapy in the     patients with local advanced non-small cell lung cancer.   "
228472|NCT00846456|"     The study induces an immune response towards the stem-cell like part of glioblastomas in     combination with standard therapy. The aim is to define and characterize the feasibility,     potential adverse effects of such therapy and measure time to progression and survival.   "
228473|NCT00846469|"     The purpose of this study is to determine the usefulness of CCTA (Coronary Computed     Tomography Angiography) in the emergency room setting to diagnose and predict the outcome of     patients with chest pain who have a low to moderate risk of heart disease.      And to also determine if the use of CCTA(Coronary Computed Tomography Angiography) is more     cost effective (cost less) than the current standards of care treatments. To determine if     patients who present to the emergency room w/low to moderate probability of having an ACS     (Acute Coronary Syndrome) prefer CCTA (coronary computed tomography angiography)-based care     compared to standard algorithm based care.   "
228474|NCT00846482|"     This study is for patients with advanced or stage II and III colon or rectal cancer. The     primary purpose of this research study is to determine if a particular protein in the     patient's blood will change when they receive treatment with a drug called oxaliplatin, which     is used to treat the colon or rectal cancer. This protein is called ERCC-1. It is thought     that the amount of this protein in the blood could influence the manner in which the patient     responds to oxaliplatin.   "
228536|NCT00847301|"     An observational cohort study on safety and efficacy to generate additional data on the     benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment   "
228475|NCT00846495|"     Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during     a 1-month Baseline Period, subjects will treat with their usual medication and document any     warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization     (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during     Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit     3.This study will compare the effectiveness of daily treatment vs. treatment during the     pre-headache phase for prevention of migraine.   "
228476|NCT00846508|"     This phase III study is designed to examine if low-risk, as defined by clinical and     radiological parameters, stage IB-IIB cervical cancer patients treated by cisplatin-based     chemoradiation, which is a recommended method by today's standard, have greater toxicities     but similar survival rate as those treated by radiotherapy (RT) alone. Patients will be     primarily treated with radiotherapy with same protocol, but without concurrent chemotherapy     in the control arm, and with weekly cisplatin (40 mg/M2) for 6 courses in the study arm. This     study will be conducted at all branches of Chang Gung Memorial Hospital except Chia-I.      Patients will be randomized to either arm after stratification of risk factors. Each arm will     recruit 104 patients who have no LN and systemic metastasis as defined by CT/MRI and FDG-PET.     The primary end point is grade 3-5 late toxicities, and secondary end points are 1)     recurrence free survival; 2) acute toxicity of treatments; 3) sites of recurrence; 4) quality     of life; 5) total treatment time. It is expected to take 5 years to recruit enough case     number.   "
228491|NCT00846703|"     The Guangdong work group of childhood acute lymphoblastic leukemia (ALL) therapy was set up     in October 2002. The investigators treated the childhood ALL with a GZ2002 protocol since the     year 2002, and the protocol was mainly derived from the ALLIC-BFM 2002 protocol. After     summarizing the last six years' experience, our group revised the GZ2002 ALL protocol in the     year 2008, which is named GD-2008 ALL protocol. The diagnosis and classified criteria is     according to the ALLIC-BFM 2002 protocol, and the chemotherapy protocol consists all the     therapeutic phases as the ALLIC-BFM 2002 protocol prescribed.   "
228492|NCT00846716|"     The purpose of this study is to investigate whether the oral anti-diabetic drug, Thiazolidine     (TZD) is effective in suppression of onset or progressin of diabetic nephropathy in Japanese     type 2 diabetic patients.   "
228477|NCT00846521|"     The main purpose of this study is to determine whether treatment with acarbose attenuates     post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined     by continuous glucose monitoring systems (CGMS). To this effect the current pilot study     involves a 6 week intervention with acarbose given to all subjects with either impaired     glucose tolerance or an area under the curve of >130 mg/dl during the screening oral glucose     tolerance test. Three consecutive days of CGMS are then compared to before and during the     intervention. The secondary objective addressed in this protocol is the collection of     baseline measures of endothelial function in obese and lean children. Even though the     duration of acarbose treatment may be too short to demonstrate a vascular effect, the pre and     post intervention data would serve as preliminary data for anticipated future studies that     assess the vascular effect of reduced post-prandial blood glucose levels.   "
228478|NCT00846534|"     The purpose of the investigators study is to investigate the correlation between naturally     occurring chemicals, called reactive oxygen species (ROS), in the blood of human patients and     the development of an abnormal heart rhythm, known as atrial fibrillation (AF). The     development of atrial fibrillation is associated with increased medical problems like stroke.     Many factors seem to cause the development of AF, and this rhythm occurs frequently after     open heart surgery. When patients develop AF after cardiac surgery they are at increased risk     for cognitive changes, infections, the development of kidney failure, and increased length of     hospitalization. ROS are chemicals in blood and tissues that tend to cause microscopic blood     vessel and heart damage. These chemicals occur naturally as the result of chemical reactions     that occur in states of stress and inflammation, like tissue trauma and as the result of     smoking. Patients who undergo cardiac surgery may have higher levels of ROS because of their     underlying medical conditions. In addition, the organized tissue trauma that occurs in the     setting of surgery may serve to increase ROS levels further. In turn, the higher ROS levels     may put patients at even higher risk for the development of AF. The investigators believe     that increased levels of ROS may help potentiate a patient's development of AF. Accordingly     the investigators aim to measure ROS levels before and after surgery to see if there are     particular levels that predict the development of this abnormal heart rhythm. By developing a     better knowledge of the relationship between ROS and AF, the investigators hope to better     understand another possible method of detecting patients who are at the highest risk of     developing AF before it occurs after surgery. If these patients are better identified, this     may eventually lead to medical treatment to prevent AF; and hopefully this will result in a     decrease of the malicious effects that result from developing this abnormal heart rhythm.   "
228479|NCT00846547|"     The study objective is to explore the safety and tolerability of STX209 in subjects with     Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in     treating irritability. We hypothesize that STX209 will be safe and well-tolerated.   "
228480|NCT00846560|"     The involvement of Lymphocyte type B in Amyotrophic lateral sclerosis (ALS) patients will be     compared to lymphocyte in healthy subjects.   "
228481|NCT00846573|"     The purpose of this study is to test the efficacy of Hyperpolarized Helium-3 gas in MR     imaging in COPD, asthmatics, CF and healthy volunteers.   "
228482|NCT00846586|"     This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when     combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients     with chronic obstructive pulmonary disease (COPD)   "
228483|NCT00846599|"     The purpose of this study is to examine the postprandial (anytime after a meal) effect of     different dietary fats on endothelial function in HIV-infected and HIV-uninfected men.   "
228484|NCT00846612|"     This study is to study pharmacokinetics of Doxil using Doxil and Avastin on ovarian cancer     patients who are resistant to or have relapsed from platinum-based therapy.   "
228485|NCT00846625|"     This is a pilot study to investigate the safety and efficacy of intravitreally administered     ranibizumab (Lucentis) compared to steroid injection for the treatment of macular edema due     to chronic non-infectious uveitis. There is currently no FDA-approved therapy for this     condition, however intravitreal injection of corticosteroids, in conjunction with oral     steroids and/or immunomodulatory drug agents, has become the mainstay of therapy. Ranibizumab     is a recombinant monoclonal antibody antigen-binding fragment that neutralizes the active     forms of vascular endothelial growth factor (VEGF), which is believed to contribute to the     etiology of inflammation and neovascularization. Ranibizumab is FDA-approved for the     treatment of neovascular age-related macular degeneration.   "
228486|NCT00846638|"     The purpose of this randomized trial is to test the effectiveness of screening and brief     intervention for risk drinking by nonpregnant women with specific medical problems     exacerbated by excessive alcohol consumption. The medical problems are female factor     infertility, hypertension, diabetes, and osteoporosis, conditions that are costly to treat     and difficult to manage. Just as pregnant women are thought to be highly motivated to modify     their alcohol consumption, so women with specific medical problems worsened by alcohol intake     are an appropriate group to receive a brief intervention.   "
228487|NCT00846651|"     The purpose of this study is to compare two methods for preventing low blood pressure     associated with spinal anesthesia during Cesarean sections.   "
228488|NCT00846664|"     Patients will be performing Logan short arc banding protocols to see the effect on multifidus     size   "
228548|NCT00847457|"     This study will evaluate whether standardized aerobic exercise is an effective treatment for     depression in adolescents.   "
228489|NCT00846677|"     Vitamin D supplementation (400 IU/d) is recommended for all breastfed infants in Canada. Such     recommendation is grounded in the fact that the prevalence of rickets in Canada is higher     than desirable, likely due to low maternal-fetal transfer and low intakes postpartum.      There is little data about adherence to supplementation in Canada, but one study shows that     in primiparous mothers (n=1937) in Quebec, 58.1 % of those exclusively breast-feeding gave     their infant vitamin D supplements in the first six months and 62.1 % of those feeding     formula did not. For the Canadian situation, it is not clear if the modality of the     supplementation is a barrier to providing the supplement. Thus the overall aim of this study     is to test a new delivery system for parental preference and infant acceptance compared to a     standard vitamin D supplement.   "
228490|NCT00846690|"     The project is a study comparing the effectiveness of two topical anesthetics for control of     pain associated with dental needle insertion in the palatal mucosa. A standard dental topical     anesthetic (20% benzocaine) will serve as an active control and will be compared to a     combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2%     phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).   "
228509|NCT00846950|"     The purpose of this study is to determine whether histamine is involved in memory and     specific processes in human cognition.   "
228510|NCT00846963|"     The purpose of this study is to determine whether ursodiol is effective in the treatment of     parenteral nutrition associated cholestasis in neonates.   "
228493|NCT00846729|"     It is our purpose in this study to compare the kidney structure and function of older     patients to that of young patients before and after removal of a single kidney for transplant     donation and to examine the remaining kidney's ability to adapt and maintain function over     time. More specifically, we aim to examine the effect of uninephrectomy on adaptive     hyperfiltration in the remaining kidney. A secondary aim is to investigate whether subjects     in the aging population undergo compensation to the same extent as younger subjects. We will     also examine the compensatory rise in GFR (glomerular filtration rate) that follows     uninephrectomy in both groups, and, again, compare the results in the aged versus young     subjects. This will help in delineating the extent to which the aging population can be a     potential source of living kidney donors for kidney transplantation.      It is also our purpose with this study to refine the tests to be used in the donor evaluation     process so as to accurately identify ideal candidates for safe kidney donation.   "
228494|NCT00846742|"     This phase II trial is studying how well combination chemotherapy with or without radiation     therapy works in treating young patients with favorable-risk Hodgkin lymphoma. Drugs used in     chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride,     vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving     more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy     uses high-energy x-rays to kill cancer cells for those patients that still had residual     cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may     kill more cancer cells and allow doctors to save the part of the body where the cancer     started.   "
228495|NCT00846755|"     The purpose of this study is to determine whether treatment of thyroid disease during     pregnancy decrease the incidence of adverse outcome, and to compare the impact of Universal     Screening versus case Finding strategy in detecting thyroid dysfunction   "
228496|NCT00846768|"     The primary objective of the trial is to determine the effect of BI 17444Cl on the lung     function over a 24-hour period, when it is inhaled using the Respimat inhaler in patients     with chronic obstructive pulmonary disease. In the trial four treatments of each 3 weeks of     duration are included: 2 dosages in a once daily administration and 2 dosages for     administration twice daily.   "
228497|NCT00846781|"     The purpose of this study is to obtain data on the potential of long-term treatment with     denufosol to improve the clinical course of CF lung disease in patients with mildly impaired     lung function and to provide CF patients who completed study 08-110 continued access to     denufosol.   "
228498|NCT00846794|"     This research is designed to study the reliability of the results of an AcuGraph in college     students and faculty members with reported digestive symptoms   "
228499|NCT00846807|"     An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate     additional data in predefined sub populations of patients at increased risk of bleeding or     VTE   "
228500|NCT00846833|"     We hypothesized that haploidentical NK cells kill tumor cells more efficiently than     autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study     to investigate the role of haploidentical NK cell therapy in patients with refractory or     relapsed malignant melanoma.   "
228501|NCT00846846|"     In order to expand safety information in patients treated with the Endeavor Drug Eluting     Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT     Trial. The amended study is PROTECT CONTINUED ACCESS (PROTECT CA).   "
228502|NCT00846859|"     The aim of the present clinical trial is to investigate whether 14 weeks of treatment with a     prescription medication for smoking cessation (European trade name: Champix(R); US trade     name: Chantix(R)), can reduce alcohol consumption in alcohol dependent individuals.   "
228503|NCT00846872|"     The hypothesis is that GHRP-3 will exert beneficial effects on endothelial function and     insulin resistance in older men and women via hormonal (GH, IGF-I, IGFBP-3,-1, insulin) and     non-hormonal actions (anti-inflammatory).   "
228504|NCT00846885|"     The objective of this study is to compare the rate and extent of absorption of sumatriptan     from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex®     100 mg Tablets under fed conditions.   "
228549|NCT00847470|"     The purpose of this study was to document the reasons for placing the first restoration     (filling) on a previously un-restored surface in a permanent (adult) tooth.   "
228506|NCT00846911|"     The objective of this global non-interventional study is to evaluate the impact of Acute     Exacerbation of Chronic Bronchitis(AECB) on the patient and the community as well as the     safety and effect of a treatment with Moxifloxacin tablets in daily life clinical practice.     This includes data on the course of symptom relief, speed of return to normal daily life     activities as well as records on adverse events.      This study will be performed in accordance with international guidelines like EMEA (EMEA,     EUDRALEX Volume 9A, Pharmacovigilance for Medicinal Products for Human Use) as well as local     laws.   "
228507|NCT00846924|"     Atrial fibrillation is the most common cardiac cause of ischemic stroke. Detecting atrial     fibrillation after a stroke or TIA is critical because highly effective secondary stroke     prevention therapy is available for individuals who are recognized to have atrial     fibrillation. However, atrial fibrillation is likely under-diagnosed after stroke and TIA     because atrial fibrillation is often difficult to detect as it is frequently paroxysmal and     asymptomatic, and patients do not routinely undergo prolonged screening. The purpose of this     study is to determine the diagnostic yield of a novel 30-day cardiac event monitor compared     to a repeat 24-hour Holter monitor for detecting occult paroxysmal atrial fibrillation in     patients with a recent ischemic stroke or TIA of undetermined etiology after completion of a     standard clinical stroke work-up (including an initial negative Holter monitor.)   "
228508|NCT00846937|"     We aim to examine efficacy of a plant stanolester beverage to lower serum cholesterol and     LDL-cholesterol levels, when given with or without a fatty acid preparation. Study subjects     are otherwise healthy proctocolectomized ileostoma patients (n=10), who consume stanolester     beverage with or without a fatty acid preparation in a random order for one week period after     a standardized low-fat meal. Washout period is 4 weeks. Serum lipids, lipoprotein lipids,     sterols and fecal sterols and variables of cholesterol metabolism will be examined     accordingly.   "
228513|NCT00847002|"     This is a study to compare the healing process of venous stasis ulcers when the Flexitouch®     system is added to the standard treatment of venous ulcers. We hypothesize that adding the     Flexitouch® system to standard venous ulcer treatment will result in        1. greater complete healing        2. greater percentage reduction in ulcer area        3. reduced time to complete healing, as compared to the use of standard treatment alone        4. a greater reduction in affected leg volume as compared to standard treatment alone.   "
228514|NCT00847015|"     The purpose of this study is to find out if using the combination of standard chemotherapy     (gemcitabine and cisplatin) plus this new targeted pill (sunitinib) can help shrink your     tumor before you undergo surgery for your bladder cancer.   "
228515|NCT00847028|"     This study investigates which concentration of glucose is most effective in reducing pain for     venipuncture in the newborn.   "
228516|NCT00847041|"     The purpose of this study is to compare the bacteria, fungi, and viruses that are present in     the sinuses of patients with chronic rhinosinusitis to patients without sinus disease using a     new technology, called a microarray, that will allow more accurate identification of     microorganisms than current laboratory methods.   "
228517|NCT00847054|"     The purpose of this study is to determine the safety of multiple intravenous infusions of     MORAb-004.   "
228518|NCT00847067|"     The purpose of this study is to learn if paravertebral block (PVB) will reduce chronic pain     after surgery. Our hypothesis is that chronic pain from breast surgery as a consequence of     central sensitization can be prevented by blocking sensory input to the CNS during surgery     and the immediate post-operative period.   "
228519|NCT00847080|"     The purpose of this study is to determine whether sitagliptin is effective in the treatment     of reactive hypoglycemia by dysinsulinism.   "
228520|NCT00847093|"     After surgery on his penis, your child will probably have some pain. The investigators will     give you a prescription for acetaminophen (Tylenol) with codeine, given by mouth (orally),     for pain. In this study, the investigators want to see if a local anesthetic cream applied to     the base of the shaft of the penis can reduce the need for oral medicine .   "
228521|NCT00847106|"     Dendritic cells (DC) are the professional antigen presenting cells of the immune system.     Multiple distinct DC lineage's exist and it is now well appreciated that the DC subset and     the maturation stage of the DC determines the type of immune response, ranging from a TH1 or     TH2 response to immune tolerance. The extremely potent capacity of mature DC to initiate     immune responses can be exploited to fight infectious diseases and cancer. Others and we are     currently using tumor antigen loaded mature DC in clinical vaccination studies against     cancer, and clinical as well as immunological responses have been observed.      Exciting new insights accompany the revival of suppressor T cells, now referred to as     regulatory T cells (Treg), and implicate that also Treg play a key role in the control of     immunity. Treg constitute a sub-population of CD4+ T cells constitutively expressing the     IL-2R alpha-chain (CD25). Treg show remarkably suppressive activities on different components     of the immune system, including T lymphocytes and dendritic cells, suggesting they act both     at the initiation phase (DC) and at the effector phase (activated T cells) of the immune     response. Interestingly, temporal depletion of Treg has been shown to enhance anti-tumor     immune responses and in case of prolonged absence of Treg even autoimmunity. Furthermore,     data in mouse tumor models indicate that temporal depletion of Treg also results in improved     vaccine efficiency in the therapeutic setting, e.g. in mice with a pre-existing tumor. These     data imply that in tumor bearing patients depletion of Treg prior to vaccination will improve     vaccine efficacy.      In this study we investigate the effect of regulatory T cell (Treg) depletion on the efficacy     of DC-based anti-tumor vaccines in a clinical study using melanoma associated antigens     tyrosinase and gp100-loaded DC and a depleting anti-CD25 mononuclear antibody (Daclizumab).     Our primary objective in this study is the induction of an effective anti-tumor immune     response. Our secondary objective is the induction of a clinical response.   "
228522|NCT00847119|"     The project objective is to evaluate the efficacy of the neoadjuvant treatment with     bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable     locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and     without distant metastases.   "
228550|NCT00847483|"     Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost   "
228523|NCT00847132|"     Depression in cardiac patients is common, persistent, and deadly. However, the vast majority     of cardiac patients with depression go unrecognized and untreated, despite the existence of     treatments that clearly improve depressive symptoms and may favorably impact survival. Our     research group and others have found that depression recognition and treatment appears     particularly limited among patients with acute cardiac illness, though this population may be     the most vulnerable to the deleterious effects of depression. We propose a project, building     on successful collaborative care depression management programs in outpatient settings, to     address this important issue.      The specific hypotheses behind the proposed research are that a collaborative care depression     management program can be successfully adapted to inpatient cardiac units, and that such a     program will lead to greater rates of adequate depression treatment and improvements in     secondary outcomes.      The following specific aims capture the stepwise goals of this program:        1. To determine whether a collaborative care depression management program ('Enhanced          Care') leads to significantly increased rates of adequate depression treatment compared          to usual care (screening and feedback) (Primary Aim).        2. To assess whether this Enhanced Care program has a lasting impact on adequate depression          treatment, depressive symptoms, health-related quality of life, and adherence to medical          recommendations at 6 weeks, 12 weeks, and 6 months, compared to usual care.   "
228524|NCT00847145|"     The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and     Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster     at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers   "
228525|NCT00847158|"     This was a prospective, double-masked, 15-month clinical trial comparing efficacy of     phacoemulsification alone to combined phacoemulsification and implantation of the iStent®     trabecular micro-bypass stent in patients with primary open-angle glaucoma.   "
228526|NCT00847171|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Vaccines made from gene-modified tumor cells may     help the body build an immune response to kill tumor cells. Giving trastuzumab together with     cyclophosphamide and vaccine therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving trastuzumab together with     cyclophosphamide and vaccine therapy in treating patients with high-risk or metastatic breast     cancer.   "
228530|NCT00847223|"     To determine the EFFICACY and the SAFETY PROFILE and TOXICITY of Zarnestra® in the treatment     of patients with previously treated mantle cell lymphoma not appropriate for autologous bone     marrow transplantation. 27 evaluable subjects will be enrolled for an analysis in 2 stages     (11 for the first stage, 16 for the second).      Patients who receive at least one dose of Zarnestra® and have at least one post-baseline     response assessment of discontinued study frug for early progression are evaluable. Subjects     not evaluable for response will be replaced, up to 35 patients.   "
228531|NCT00847236|"     The aim of this study is to evaluate a simple and rapid method in order to better define and     treat Polymyalgia Rheumatica by measuring levels of muscle achiness and pain with a blood     pressure cuff.   "
228532|NCT00847249|"     The aims of the study are to assess the safety, tolerability, pharmacokinetics, and     pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male     subjects.   "
228533|NCT00847262|"     Recent studies have shown that obese people are more prone to high blood pressure. With the     co-existence of obesity, hypertension and diabetes, patients were more susceptible to     hyperlipidemia, coronary and cerebral atherosclerosis and peripheral vascular disease.     Abdominal obesity has often accompanied by substantial accumulation of visceral fat, which     increased secretion of many inflammatory mediators, cytokines and adipocytokines and played     an important role in cardiovascular and metabolic disease. Some reports had shown that     angiotensin II receptor blockers (ARB) may improve metabolic profiles in patients with     diabetes or metabolic syndrome, in addition to its hypotensive effect. It has been reported     that some ARB, such as telmisartan and candesartan, can prevent weight gain and     high-fat-induced obesity in experimental animals. However, whether telmisartan intervention     on improvement of fat deposition and other related metabolic profiles is better than a CCB     drugs (amlodipine) in those obese hypertensive patients with diabetes, was still unknown.   "
228534|NCT00847275|"     The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly     patients aged over 75 years with renal insufficiency stage 5 will be included in the study     after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in     the exclusive nephrology follow-up arm will continue their usual follow-up; 250 patients in     the geriatric follow-up arm will have both their usual nephrology follow-up and a geriatric     follow-up.The aim of the study is to determine if a systematized gerontologist evaluation     delay the occurrence of a composite primary endpoint : death, dementia, depression and severe     dependency. The hypothesis is that the functional and vital prognosis of a patient with renal     insufficiency depends not only on common and classical factors but also on cognitive and     psychological functions and dependence, particularly in elderly patients.   "
228535|NCT00847288|"     Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized,     multi-center, post-market clinical trial in the United States. The purpose of this clinical     trial is to compare monthly versus quarterly review of Cardiac Compass® Trends with OptiVol     for initiation of clinical action. It is hypothesized that monthly review of Cardiac Compass     Trends with OptiVol will shorten time to clinical action as compared to quarterly review.   "
228537|NCT00847314|"     With advancing age testosterone levels decline in men. Low testosterone levels plus certain     symptoms are called Late Onset Hypogonadism (LOH). Adipose tissue may contribute to     testosterone deficiency. On the other hand testosterone deficiency again leads to a decrease     in lean body mass and an increase in fat mass - one of the clinical signs / symptoms of LOH.     Lifestyle changes (diet, exercise) alone or in combination with testosterone replacement     (TRT), have an influence on the symptoms of LOH. The aim of this study is to assess the     additional impact of TRT on Aging Male Symptom Score (AMS) and adiposity (waist     circumference) in patients, who are on a diet and exercise program.   "
228538|NCT00847327|"     Type 1 diabetes is a lifelong metabolic disorder that affects 1 out of every 400-600 American     children each year, with many children being diagnosed at younger and younger ages.      To achieve proper diabetes control, it is necessary to conform or adhere one's behavior to a     physician-prescribed diabetes self-care regimen. As such, parents of children with Type 1     diabetes must be highly involved in managing their child's disease on a daily basis,     especially parents of affected children who are very young and more highly dependent upon     parental caretaking.      As children diagnosed with Type 1 diabetes at a very young age may be at an increased risk     for the development of long-term behavioral and medical complications, more research is     needed to understand and treat the leading contributors to diabetes-related parental distress     and medical outcomes among this growing subgroup.      Recent findings indicate that responsibility for diabetes management falls heavily on     mothers. The majority of families do not receive outside child care assistance and report     feeling overwhelmed. Parents report high levels of pediatric parenting stress difficulty, as     well as moderate symptoms of anxiety. The current study aims to expand such preliminary     findings and specifically examine the effects of a newly-developed parenting support program     for parents of young children with Type 1 diabetes. The utility of the intervention will be     evaluated. It is hypothesized that parents completing the parent support program will report     lower levels of psychosocial distress and improved quality of life. It is hypothesized that     the children of participating parents will also demonstrate improved quality of life and     metabolic control.   "
228539|NCT00847340|"     HPV infection has been recognized as the most prevalent sexual transmitted infection     worldwide. Burden of many HPV related diseases is well known particularly regarding the     different associated cancers (cervical, anal, vaginal, vulvar, oro-pharyngeal) (3) ; however,     there is much less available information on the general burden of genital warts, the     associated HPV types, the costs of related medical treatments and the knowledge and     perceptions towards the disease and its prevention.      Objectives:        1. To determine the HPV genotypes distribution in genital warts in the study population.        2. To assess the knowledge about transmission & prevention of HPV infection related          diseases        3. To determine the direct medical costs of genital warts attention.   "
228540|NCT00847353|"     The main objective of this study is to investigate depolarization characteristics represented     by changes in HyperQ in asymptomatic, apparently healthy athletic and non-athletic     individuals. We also aim to examine a subgroup of obese and non-obese subjects. The goal of     the study is to establish normal HyperQ values in these populations and compare HyperQ values     of age-matched athletic vs. non-athletic individuals of similar health status.   "
228542|NCT00847379|"     Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It     is caused by a mutation in the gene for dystrophin, a protein that is important for     maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility     that leads to weakness and loss of walking ability during childhood and teenage years. A     specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of     DMD/BMD in approximately 10-15% of boys with the disease. Ataluren (PTC124) is an orally     delivered, investigational drug that has the potential to overcome the effects of the     nonsense mutation. This study is a Phase 2b extension trial that will evaluate the long-term     safety of ataluren (PTC124) in boys with nonsense mutation DMD/BMD, as determined by adverse     events and laboratory abnormalities. The study will also assess changes in walking, muscle     function, and other important clinical and laboratory measures.   "
228543|NCT00847392|"     This is a randomized controlled trial evaluating the effectiveness of bedside volumetric     bladder ultrasound prior to transurethral catheterization of pediatric patients presenting to     an emergency department with suspected urinary tract infection.      Ultrasound prior to catheterization allows Emergency Physicians to determine if the urine     volume of the bladder is sufficient for successful catheterization. Advance knowledge of     insufficient urine allows the Emergency Physician to defer the procedure until success is     likely.   "
228544|NCT00847405|"     The objective of this study is to compare the rate and extent of absorption of sumatriptan     from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex®     100 mg Tablets under fasting conditions.   "
228545|NCT00847418|"     The purpose of this study is the determination of blood concentration and the effectiveness     of esketamine after nasal application.   "
228546|NCT00847431|"     The goal of this study is to determine the vulnerability of mood-related neurocircuitry in     Parkinson Disease (PD) using deep brain stimulation of the subthalamic nucleus (STN DBS).   "
228547|NCT00847444|"     This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III     study comparing the disease free survival after randomisation in patients treated with 3     cycles of Epirubicine-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles     of Docetaxel(D)-chemotherapy, versus 6 cycles of Docetaxel- Cyclophosphamide     (DC)-chemotherapy, and to compare the disease free survival in patients with BMI of 24 - 40     kg/m² after randomisation with versus without the lifestyle intervention. Patients will be     required to have histopathological proof of a HER2/neu negative tumor and: axillary lymph     node metastases (pN1-3) or high risk node negative, defined as: 'pT ≥2 or histopathological     grade 3, or age ≤35 or negative hormone receptor status, but are not allowed to have evidence     of distant disease. Patients will have to be entered into the study no later than 6 weeks     after complete resection of the primary tumor. No other antineoplastic treatment other than     surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be     allowed prior to study entry and during the course of the study.   "
228552|NCT00847509|"     Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and     neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen     (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre     therapy PET/CT imaging visit, and one (3-5 weeks after the start of therapy) post PET/CT     imaging visit. This study will evaluate the FLT and FDG images for tumor proliferation rates     for early assessment of tumor response to radiation or chemo-radiation combo.   "
228553|NCT00847522|"     The purpose of this research study is to use two different drugs to find where melanoma might     spread and to remove these tissues. We believe that tumor cells from the melanoma first move     through the lymphatic system (a system of clear fluid that moves around the body and carries     white blood cells, much like the blood system) to a lymph node in an orderly way. If we can     identify the first lymph nodes to receive a tumor cell, this can be removed and examined. We     currently use one drug, called technetium-99m sulfur colloid which can detect about 90% of     the first lymph nodes that the tumor cells would move to. Technetium-99m is a radioactive     compound and can be detected through the skin by a special instrument that reads     radioactivity. As part of this research, we would like to use a second drug called     fluorescein (Fluorescite®) to see if it will identify the same lymph nodes or additional     ones and examine these. This drug is fluorescent and can be detected even through the skin     using a blue light. This drug is approved by the Federal Drug Administration (FDA) to for     injection in the vein as a diagnostic aid and has been safely used in people for many years.     In this study, we will be injecting it under the skin, which is a different use from how it     is currently approved by the FDA. In the past another drug has been used, called isosulfan     blue (Lymphazurin®), but availability of this drug is currently limited, and it has higher     risks associated with it.      This study is being conducted by Dr. Robert Andtbacka, Dr. Dirk Noyes, Dr. James McGreevy and     at University of Utah. This study is a Phase I/II and is done to find out if the drug can be     used safely when given under the skin and if it will work for this purpose.   "
228554|NCT00847535|"     This is a clinical investigation approved by US FDA and Canadian Health Authority to study     the safety and potential effectiveness of the autologous muscle cells for the treatment of     stress urinary incontinence.   "
228555|NCT00847548|"     Intimate partner violence is a significant societal problem. However, treatment of IPV     perpetrators is far from effective, which may be partly due to the fact that the role of     substance abuse is not taken into account. There is considerable evidence that a strong     relationship between the use of alcohol and other drugs and intimate partner violence exists.     Besides, a few studies indicate that reducing substance use may have a positive impact on     IPV. Therefore, in this study, perpetrators of intimate partner violence with substance use     disorders enrolled in domestic violence treatment will be randomly assigned to either     standard treatment for offenders of domestic violence or a combination of the latter     treatment with cognitive-behavioral therapy addressing substance abuse (combined treatment).   "
228556|NCT00847561|"     This study will test the effectiveness of a family-based, cognitive behavioral therapy     (CBT)-based program for preventing anxiety disorders in at-risk children.   "
228596|NCT00848094|"     The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of     3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy     (IMRT) for locally advanced hepatocellular carcinoma (HCC).   "
228557|NCT00847574|"     The WORLD study is a single-center, year-long randomized controlled trial in free-living     women. Participants were randomly assigned to follow either a lower-fat (LF) diet or a     moderate-fat (MF) diet for weight management in a parallel-arm design. The two phases of the     study were a weight-loss phase (phase 1) and a weight-maintenance phase (phase 2) (Figure 1).     During phase 1, months 1 through 4, participants consumed a hypo-caloric diet consistent with     the 2005 Dietary Guidelines in the free-living environment. During phase 2, months 5 through     12, participants shifted into weight maintenance. It was hypothesized that a weight-loss     intervention at the extremes of dietary fat recommendations of the 2005 Dietary Guidelines     would be equally effective for weight loss while achieving comparable nutrient adequacy.     Also, Overall, the lower-fat and moderate-fat diets would both be nutritionally adequate,     based on the Healthy Eating Index.   "
228558|NCT00847587|"     A highly effective single rod contraceptive implant is now available for use in the US.     Delays in the insertion of the device until later in the postpartum period may negatively     impact initiation rates. The objective of this study is to compare outcomes of early     postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing     contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary     outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of     breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side     effects, time to resume sexual intercourse after delivery, and incidence of missed routine     postpartum follow-up. In addition, a subset of patients who randomize to early postpartum     insertion will have expressed breastmilk ascertained for nutrient composition.   "
228559|NCT00847600|"     Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the central nervous     system, and may be beneficial in the treatment of patients with schizophrenia. Our recent     8-week, randomized, double-blind trial among patients with chronic schizophrenia and     schizoaffective disorders, in which PREG versus placebo and DHEA have been added to     conventional or atypical antipsychotics have yielded encouraging results with low-dose PREG     (30 mg/day; ClinicalTrials.gov identifier NCT00140192; Ritsner et al., in press). The goal of     the present study is to evaluate the potential role of PREG's augmentation compared to     placebo in the treatment of young patients with newly diagnosed schizophrenia or     schizophreniform or schizoaffective disorders.      In a 8-week, randomized, double-blind placebo-controlled trial PREG (50 mg/day) or placebo     capsules will be added to the stable ongoing antipsychotic treatment of 60 patients with     recent-onset schizophrenia or schizophreniform or schizoaffective disorders. Participants     will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of     research instruments will be used for assessment of psychopathology, cognitive functions,     side effects, general functioning and quality of life. In addition blood PREG levels will be     monitored at baseline and during the study. The study is powered to detect moderate     between-group effects on persistent positive, negative and cognitive symptoms.   "
228560|NCT00847613|"     This study is designed to provide safety and efficacy data to support the development of     CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of     methotrexate.   "
228562|NCT00847639|"     This is a multi-institution, non-randomized, open label, Phase IIa prospective trial to     evaluate the safety and tolerability of maintenance lenalidomide after allogeneic     hematopoietic stem cell transplantation (HCT).      Lenalidomide maintenance therapy will start between day 60 and 90 after allogeneic HCT at a     starting dose of 10mg PO once daily. Dose escalation and de-escalation will be performed     depending on tolerability of lenalidomide. Dose range is 5mg every other day to 5 - 25 mg     given daily on days 1-21 of a 28-day cycle for 12 cycles maximum or maximum of 12 months from     first dose of study drug.      Patients will be followed until 28 days from completing the 12th planned cycle of     lenalidomide maintenance or 12 months from first dose of study drug, which ever comes first,     (14 to 15 months after receiving the allograft) or discontinuation of study drug.   "
228563|NCT00847665|"     The purpose of this study is to compare a 2-hour versus every 4-hour turning regimen on the     incidence of grade > II pressure ulcers (PU) in patients in ICU on mechanical ventilation ≥     24h that use alternating-pressure air mattresses (APAMs).   "
228564|NCT00847678|"     This is a multicenter, randomized, efficacy and safety trial to evaluate Mycograb®. Subjects     will be randomized to one of the 3 arms: 1/ Amphotericin B (0.7 mg/kg/d) plus 5-flucytosine     (100 mg /kg/d); 2/ Amphotericin B plus Mycograb® (dosed 1 mg/kg via a central line or     peripheral venous line twice daily for 7 consecutive days); 3/ Amphotericin B plus     5-flucytosine plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line     twice daily for 7 consecutive days). After 2 weeks, all patients will be switched to     fluconazole at 400 mg/d for 8 weeks and 200 mg/d thereafter. The total duration of the study     will be approximately 24 months   "
228565|NCT00847691|"     The clinical and histological diagnosis of sarcomas is often very difficult. The     identification of chromosomal and molecular anomalies, such as amplifications, deletions or     fusion genes is a powerful help for establishing a correct diagnosis of sarcomas and their     benign counterparts. However, the cost of the cytogenetic and molecular techniques for the     detection of these alterations is often a limitation to their use. The aim of our study is to     evaluate the direct cost of the molecular techniques in comparison to the cost that would be     generated by an appropriate therapy and care management of the patient in case of an     erroneous diagnosis.   "
228566|NCT00847704|"     This study investigates whether assisted movement with biofeedback and muscle vibration     applied to the lower limb reduces impairment and improves gait.   "
228567|NCT00847717|"     The treatment of clinically N0 neck in malignancies of oral cavity is controversial. The     options include the policy of wait and watch(close observation and follow-up), elective     irradiation of the neck, elective surgery of the neck (neck dissection).      In elective neck dissections, the procedures commonly performed are modified radical neck     dissection-III (functional neck dissection) and selective (supraomohyoid) neck dissection     depending on the site of the primary lesion within the oral cavity. There are no trials of     IIb preserving neck dissection in cancers of the oral cavity.   "
228568|NCT00847730|"     The study is aimed at evaluating the clinician's preceived ease of using the V.A.C. GranuForm     bride dressing and the patients perceived level of comfort during the dressing wear.   "
228569|NCT00847743|"     Oxidative stress has been linked to many diseases associated with aging, including coronary     heart disease and Alzheimer's disease. Antioxidants and special proteins in the body work     together to help prevent damage by free radicals. Some studies have indicated that as people     age, they are less able to fight off oxidative stress and have increased levels of     inflammation.      Tart cherries are known to be rich in antioxidants and plant-nutrients. The product we are     using in this study is an all-natural tart cherry juice, mixed with apple juice concentrate     and containing no additives and no preservatives.      We hope to learn whether antioxidant supplementation, such as tart cherry juice, can     measurably decrease oxidative damage and inflammation associated with aging.   "
228570|NCT00847756|"     Otitis Media (OM) is one of the most frequent diseases in childhood and the primary reason     for children to visit a physician. In many countries it is the most common reason to     prescribe antibiotics leading to increased drug-resistance of the causative agents, or to     undergo surgery. Costs for general health care are expanding, and are estimated to be 3-5     billion dollar annually in the United States. Prevention is suspected to be an important     solution to this problem.      Although OM management has no universal standard yet, it may imply watchful waiting,     antibiotic treatment, adenoidectomy, insertion of tympanostomy tubes and (future)     vaccination. Approximately 80% of the acute otitis media (AOM) cases is self-limiting within     2-14 days and also otitis media with effusion (OME) resolves spontaneously: 60% of newly     detected OME resolves within 3 months. However, in a significant part of the OM population     persistent or recurrent episodes of OM are responsible for a significant morbidity for both     children and parents, despite variable treatment options.      Through the set up of a new prospective cohort in a clinical setting, relevant patient     characteristics, the role of bacterial and viral pathogens, the role of recurrent infection     in relation to biofilm formation, and the host response at protein level will be studied in     detail. This project is expected to increase the understanding of the underlying mechanisms     of OM disease, which will support future treatment and prevention strategies. Better     understanding in OM pathogenesis is warranted in order to develop these novel preventive     strategies.   "
228571|NCT00847769|"     The purpose of this study is to determine changes in the brain associated with improvement in     ankle range of motion following ankle manual therapy procedures in individuals with     post-acute ankle sprains   "
228572|NCT00847782|"     The purpose of this study is to validate novel assays for serum biomarkers of lipid     metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers     differ in subjects with normal or high cholesterol levels   "
228573|NCT00847795|"     An exploratory Phase-II trial with intradermal RN1001 (Avotermin) to investigate scar     prevention and reduction and acceleration of healing. The trial has an additional objective     to evaluate several different scar assessment techniques that can be used in future clinical     trials in the prevention and reduction of scarring.   "
228574|NCT00847808|"     The purpose of this study is to determine if patients with well-controlled heartburn symptoms     on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to     once-daily (QD) dexlansoprazole modified release (MR) 30 mg.   "
228575|NCT00847821|"     This study is an observational study analyzing the biopsy samples collected from subjects     that participated in Study 3115A1-303 (NCT00675688). These endometrial biopsy samples will be     de-identified at an anatomical laboratory and then sent to a molecular biology lab where an     RNA extraction and analysis will be performed. The purpose of this study is to compare     specific endometrial gene regulation at the level of mRNA expression in samples from placebo,     bazedoxifene/conjugated estrogens, and raloxifene treated groups with a known set of genes     that have been previously identified to be associated with estrogenization, endometrial     hyperplasia, and endometrial cancer.   "
228576|NCT00847834|"     To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the     treatment of patients with mild to moderate primary hypertension.   "
228577|NCT00847847|"     Consistent data suggest that neuromuscular transmission is impaired in ALS patients.     Neuromuscular junctions dysfunction may appear very early in the disease, as shown by data in     animal models. The pathogenesis of this neuromuscular transmission impairment is unknown.     Nogo A isoform, a possible marker of the disease over-expressed in skeletal muscle of ALS     patients, can be involved. We will characterize the pathophysiological mechanisms implicated     using a complete study of the structure and function of the NMJ on muscle biopsies, in a     group of 20 ALS patients compared to 10 controls.   "
228578|NCT00847860|"     The purpose of this study is to evaluate the efficacy of PDE-3 inhibitor, cilostazol, in     prevention and treatment of vascular dementia, in those with brain white matter lesions and     vascular risk factors.   "
228579|NCT00847873|"     Intimate partner violence is a significant societal problem. There is considerable evidence     that a strong relationship between the use of alcohol and other drugs and intimate partner     violence exists. Besides, a few studies indicate that reducing substance use may have a     positive impact on IPV. Therefore, in this study, patients in substance abuse treatment for     the use of alcohol, cannabis or cocaine who also admit to perpetrating intimate partner     violence will be randomly assigned to either cognitive behavioral therapy addressing     substance abuse combined with treatment for offenders of intimate partner violence or     substance abuse treatment alone.   "
228580|NCT00847886|"     The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX)     pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in     subjects with stable rheumatoid arthritis that are receiving stable doses of MTX.   "
228581|NCT00847899|"     The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH     enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with     impaired glucose tolerance and mild to moderate hypertension.   "
228592|NCT00848042|"     This is an open-label, multicenter, single-dose pilot study of AuroLase(TM) Therapy in the     treatment of patients with refractory and/or recurrent tumors of the head and neck. Three (3)     treatment groups of five (5) patients each will be enrolled and observed for six (6) months     following treatment. Each group will receive a single dose of AuroShell(TM) particles     followed by one or more interstitial illuminations with an 808nm laser. Particle dose and     laser power may be increased in each dosing group.   "
228582|NCT00847912|"     The main purpose of this study is to see if 5-fluorouracil (5-FU) skin cream can prevent the     growth of new skin cancers on the face and ears. The cost of trying to prevent skin cancer     will be compared to the usual cost of treating skin cancer. Participants are being asked to     be a part of this study because the participants have been treated for two or more skin     cancers within the past five (5) years. At least one of these cancers occurred on the face or     ears. Having had two or more skins cancers in the past 5 years makes it likely that     participants will develop additional skin cancers in the future.      Exposure to ultraviolet radiation from the sun or artificial sources such as tanning beds is     a major cause of basal cell and squamous cell carcinoma of the skin. Using lotions, creams,     or gels that contain sunscreens can help protect the skin from premature aging and damage     that may lead to skin cancer.      The 5-FU skin cream used in this study is FDA-approved to treat some types of skin cancers     and spots that might become skin cancer. However, 5-FU skin cream has never been studied to     see if it can prevent skin cancer. This drug is not approved by the FDA for how it will be     used in this study.      In this study, one half of the patients will use the 5-FU cream and the other half will use a     skin cream that looks identical to the 5-FU cream but does not have 5-FU or any other active     drug in it.      Approximately twelve VA medical centers will work together in this study. About one thousand     (1000) patients will be in this study. The study is sponsored by the U.S. Department of     Veterans Affairs Cooperative Studies Program.   "
228583|NCT00847925|"     A double blind, Placebo (Vehicle) and Standard Care controlled, randomised study to     investigate the clinical safety and toleration (including systemic pharmacokinetics), wound     healing and antiscarring potential of two applications of intradermal RN1001 in healthy male     subjects   "
228584|NCT00847938|"     Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to     NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is     monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a     mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in     clinical routine. Acceleromyography is the most currently monitoring available in daily     practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is     necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to     perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG     TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with     neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes     parasympathomimetic effects which has to be reversed with atropine. When neuromuscular     blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the     visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side     effects expected. The goal of the study is to compare the delay between a light neuromuscular     block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02,     0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.   "
228585|NCT00847951|"     The purpose of this study is to evaluate the effectiveness of 3D (3dimensional)renal     ultrasound to check kidney perfusion (to see if the kidney is receiving enough blood flow to     function as it should) in pre-mature and/or very low birth weight babies.   "
228601|NCT00848159|"     This study aimed to measure the degree of thoracic kyphosis in elderly women with those     affected by osteoporosis in the spine, through photogrammetry computer and check the     difference between the values obtained with the assumption of greater thoracic kyphosis in     osteoporotic women.   "
228812|NCT00848458|"     The purpose of this prospective, randomized, controlled, single-blinded investigation is to     study the efficacy, tolerability and safety of azelaic acid iontophoresis (AAI) versus     topical treatment with azelaic acid cream in female patients with melasma.   "
228586|NCT00847964|"     This is a pilot study to evaluate the feasibility and safety of the Algisyl-LVR™ device. The     purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular     restoration in patients with dilated cardiomyopathy who are scheduled to undergo routine open     heart surgery. Algisyl-LVR™ will be injected into the myocardium under direct visualization     during the surgical procedure. This clinical evaluation is intended to provide the initial     evidence of the safety and feasibility of the device as well as the procedure used to deploy     the device. The results of the initial trial will also help to establish the utility of     various assessments in evaluating and following the effects of the device.   "
228587|NCT00847977|"     isotonic NaCl serum is the first intent solution for infusion during the initial phase of     reanimation for an acute cranial traumatism.      However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious     for the future of this patient.      Isofundine present all charateristics to be use in this indication: pharmacokinetic and     pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose     provision and no interaction with hemostasis.   "
228588|NCT00847990|"     The purpose of this study is to determine if a laboratory test developed by the Sequenom     Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can     better identify pregnancies that have a child with a chromosome abnormality such as Down     syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), or other chromosome abnormality.   "
228589|NCT00848003|"     We believe a readily available drink containing a high dose of probiotics has the potential     to improve compliance through many of these mechanisms. This product also has the potential     to positively impact the health of children and adults around the world, as yogurt will     likely be more appealing to both children and their parents for long term consumption than     pharmaceutical-like preparations. In addition to the benefits associated with the consumption     of probiotics, there is an increased health benefit from consuming yogurt, a nutrient dense     food.      More specifically, the rationale for this Phase I study is to determine safety of our drink     and comply with the FDA's recommendations pertaining to an IND application, we will conduct a     phase I safety study.      We hypothesize that BB-12 is safe in healthy adults ages 18 and over.   "
228590|NCT00848016|"     This phase II trial is studying how well gossypol acetic acid works in treating patients with     recurrent, metastatic, or primary adrenocortical cancer that cannot be removed by surgery.     Drugs used in chemotherapy such as gossypol acetic acid, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.   "
228598|NCT00848120|"     This single arm, open label study will assess the safety and efficacy, with regard to     reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to     severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4     weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the     study may continue with their treatment together with tocilizumab.The anticipated time on     study treatment is 3-12 months, and the target sample size is <100 individuals.   "
228599|NCT00848133|"     The purpose of this study was to compare the early clinical outcomes of minimally invasive     bilateral subvastus and midvastus approaches for total knee arthroplasty.   "
228600|NCT00848146|"     Refinements in laparoscopic surgery, coupled with advancements in therapeutic flexible     endoscopy, have set the stage for surgery to move to even less invasive techniques to treat     conditions in the GI tract and peritoneal cavity. Natural orifice translumenal endoscopic     surgery (NOTES) offers a means of reducing and ultimately eliminating the need for abdominal     incisions to gain access to the peritoneal cavity. In NOTES, a flexible endoscope and     accessory instruments are inserted through a natural body orifice and passed through the wall     of an organ to reach the abdominal cavity. By reducing or eliminating the need for abdominal     incisions, NOTES may provide a least invasive surgical option that can reduce pain, recovery     time, complications, and systemic inflammatory response when compared to a laparoscopic     surgical approach. In this study, we propose to use the NOTES technique to eliminate the need     for a 1.5-2.5 cm umbilical incision.      Hypothesis 1: We hypothesize that a combined endoscopic and laparoscopic approach will be     able to eliminate a 1.5 to 2.5 cm infraumbilical incision when performing a laparoscopic     cholecystectomy.      Hypothesis 2: Closure of the gastrotomy will be facilitated with the Ethicon TAS system.   "
228615|NCT00848341|"     To document practices in Canadian ICD implant centres around defibrillation therapy efficacy     testing.   "
228602|NCT00848172|"     Background:        -  Essential tremor (ET) is a neurological disorder characterized by uncontrollable          shaking. Several medications are used to treat ET; however, they are often only partly          effective and can have side effects.        -  Research studies have shown that octanol, a food additive similar to alcohol, can          improve tremor in animals. Octanol is less likely to make people drunk than alcohol. Two          earlier NIH studies found that one form of octanol, called 1-octanol, did improve tremor          in some people and had few side effects.        -  In the body, 1-octanol is converted to octanoic acid. Researchers are interested in          finding out whether octanoic acid can help people with ET.      Objectives:        -  To find out if octanoic acid can improve hand tremor in people with essential tremor.        -  To measure levels of octanoic acid in the blood after it is taken.      Eligibility:        -  Patients 21 years of age and older with ET, who are willing to abstain from alcohol,          caffeine, and all medications as required by the study and who are willing and able to          fast for up to 12 hours at a time.        -  Participants may not be of Asian or Native American ancestry because of genetic          susceptibilities to the intoxicating effects of the study drug.      Design:        -  This study requires a 3-day hospital admission as well as two outpatient visits.        -  Visit 1 (outpatient): Screening visit and blood alcohol level test        -  Medical history, physical and neurological examination, a blood test, and an          electrocardiogram to measure heart function. Women who are able to get pregnant will          have a urine pregnancy test.        -  Patients will consume 1.5 ounces of alcohol per drink (up to three drinks at least 30          minutes apart), and be tested to evaluate how the tremor responds. Researchers will draw          blood to measure blood alcohol level about 1 hour after the first drink and closely          monitor patients for signs of intoxication.        -  Inpatient examination        -  Preparation: Researchers will prepare a schedule to stop any tremor medications that          patients might be on. Patients may not drink alcohol or eat or drink anything with          caffeine, including chocolate, for at least 2 days before admission.        -  Day 1: Vital signs, blood (and urine pregnancy) tests, and electrocardiogram. Patients          will be asked to wear a tremor monitor, similar to a wristwatch. Patients will also have          IV lines inserted for blood draws.        -  Days 2 and 3: Randomized study medication (octanoic acid on one day, placebo on the          other day). Patients will fast before taking the drug, but will be allowed to eat and          drink after the tests are completed (around noon).        -  Blood will be drawn before taking the study drug and again (a total of nine times) after          taking the drug.        -  Tremor will be measured during the study, before and after taking the drug.        -  Visit 2 (outpatient): 4 to 7 days after discharge        -  Blood test and an electrocardiogram, and a series of questionnaires regarding the study.   "
228603|NCT00848185|"     Introduction OHSS still remains a complication of assisted reproduction treatments. hCG     administration to trigger final oocyte maturation will release vascular mediators, being VEGF     and other proteins such as VE-Cadherin or Angiopoietin- 2. It has been shown that replacing     hCG by GnRH agonists will induce a very short endogenous LH peak, potent enough to induce     final oocyte maturation but no OHSS will develop. The investigators examined VEGF,     VE-Cadherin and Angiopoietin-2 modulation by hCG as well as GnRH agonists in oocyte donors     undergoing controlled ovarian stimulation.   "
228604|NCT00848198|"     This is a prospective, observational case series to determine the clinical utility of tear     osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to     establish referent values for objective tests of the disease.   "
228605|NCT00848211|"     This protocol represents the first in human study of TUTI-16, and is being conducted to     establish the safety and human immunogenicity (anti-HIV-1 Tat titers) of subcutaneously     administered TUTI-16. Activity of TUTI-16 will also be determined in minimizing HIV-1 viral     loads and sustaining CD4+ T-cell levels.   "
228606|NCT00848224|"     The overall goal of this study was to implement and evaluate the effects of a systems-based     and pharmacist-mediated program designed to improve adherence for patients with known     coronary heart disease (CHD) to lipid-lowering pharmacologic therapy and of their     physicians/nurse practitioners to the National Cholesterol Education Program Guidelines.   "
228607|NCT00848237|"     The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It     provides a framework for treatment and follow-up of patients with Barrett's esophagus     (non-dysplastic IM, LGD and HGD). The primary objective is to provide a tool for     participating physician investigators to collect outcomes data related to the use of the HALO     Ablation Systems.   "
228608|NCT00848250|"     The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic,     inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with     congenital heart disease.   "
228609|NCT00848263|"     Fractures of the distal radius are one of the most common orthopaedic injuries and are     associated with a high complication rate. There is a lack of clinical trials comparing the     different treatment modalities of fractures of the distal radius. The purpose of this     randomized trial is to assess differences in functional outcome, radiological results, and     complication rate in patients 55 years and older with an unstable displaced fracture of the     distal radius without articular involvement treated with a dorsal nail plate or a volar     plate.   "
228649|NCT00840840|"     The purpose of this study is to assess the bioequivalence between Amoxicillin/Clavulanate     Potassium Oral Suspension 600/42.9 mg/5 mL and Augmentin ES-600 Oral Suspension, 600/42.9     mg/5 mL in healthy, male and female subjects, under fed conditions.   "
228650|NCT00840853|"     Subjects are having a bone marrow or SCT for either a type of cancer of the blood called     Leukemia or a cancer of the lymph nodes called non- Hodgkin's Lymphoma. Although a transplant     can cure leukemia or lymphoma, some people will relapse. In those who relapse, current     treatment cures only a very small percentage. Although giving patients a dose of donor immune     cells before relapse can prevent relapse of the leukemia or lymphoma, DLI can also cause a     serious complication called graft versus host disease (GVHD). This is a gene transfer     research study using special immune cells which are specific for these cancer cells.      The body has different ways of fighting infection and disease. This study combines 2 of those     ways, antibodies and T cells. T cells (CTLs or cytotoxic T cells) are infection-fighting     blood cells that can kill cells, including tumor cells. Antibodies and T cells have been used     to treat patients with cancers; they have shown promise, but haven't been strong enough to     cure most patients.      The antibody used in this study is called anti-CD19. This antibody sticks to leukemia cells     because of a substance on the outside of these cells called CD19. For this study, the     anti-CD19 antibody has been changed so that instead of floating free in the blood it is now     joined to T cells. When an antibody is joined to a T cell in this way it's called a chimeric     receptor.      In the laboratory, investigators found that T cells that are trained to recognize common     viruses can stay in the blood stream for many years. By joining the anti-CD19 antibody to     CTLs that recognize viruses, they believe that they will also be able to make a cell that can     last a long time in the body, provide protection from viruses, and recognize and kill     leukemia. The CTLs which we will join the anti-CD19 antibody to attack 3 viruses     (trivirus-specific CTLs), CMV, EBV, and adenovirus.      CMV is a virus that rarely causes problems in healthy people but can cause serious infections     in patients with suppressed immune systems. It can cause a very serious pneumonia, and can     also affect the intestinal tract, liver and eyes. 2/3 of normal people harbor this virus in     their body. If the subject or donor are positive for CMV, the subject is at risk of     developing CMV disease after transplant. EBV causes mononucleosis or mono (infection with     fatigue, high fever, and swollen lymph nodes). It is normally controlled by a healthy immune     system but when the immune system is weak after bone marrow transplant it can cause fevers,     enlarged lymph nodes and a type of cancer called lymphoma. Adenovirus is a virus that causes     symptoms of a common cold but can cause life-threatening infections in patients with weak     immune systems.      Studies have shown that trivirus-specific CTLs grown from the stem cell donor can be given     safely to transplant recipients and can stop these viruses from causing severe infections.     These CD19 chimeric receptor trivirus specific T cells are an investigational product not     approved by the FDA.      The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to     assess the side effects, to see how long the T cells last and to evaluate whether this     therapy might help prevent infections and relapse in people with CD19+ leukemia or lymphoma     having a SCT.   "
246225|NCT01086449|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK     Biologicals' candidate Herpes Zoster (HZ) vaccine in healthy ethnic Japanese adults.   "
228610|NCT00848276|"     This study measures a recently discovered protein named PCSK9 (Proprotein convertase     subtilisin kexin 9) in blood to see if it is influenced by male and female sex hormones.     PCSK9 has recently been shown to control cholesterol and triglyceride levels by diminishing     the ability of liver cells to remove cholesterol from blood leading to high blood cholesterol     levels.      It was found in previous studies that there was a relationship between blood levels of PCSK9     and cholesterol in men but not in women. This gender difference is a new finding and it     raises the question of whether male and female hormones might influence PCSK9's role as a     blood cholesterol regulator.      The study requires a pre-treatment fasting blood sample and another sample 3 months after     starting hormone therapy.   "
228611|NCT00848289|"     This clinical research study will identify biologic and lifestyle factors which increase a     person's risk of developing specific cancer. Researchers propose to conduct a case-control     study examining interindividual differences in susceptibility to tobacco carcinogenesis as     predictors of bladder cancer risk. We will measure susceptibility to tobacco carcinogenesis     and this will include studies of the genetic modulation of carcinogen activation and     detoxification and of chromosome sensitivity to tobacco mutagens.   "
228612|NCT00848302|"     Up to 30 patients with lower extremity disease scheduled to undergo diagnostic angiography     will undergo baseline bloodwork and IVUS (intravascular ultrasound), followed by dosing with     L-arginine to assess changes in endothelial function.   "
228613|NCT00848315|"     The overall goal of this randomized clinical trial (RCT) is to test the efficacy of a     culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance     adherence to diabetes self-management behaviors and improve glycemic control among low-income     Hispanic individuals with type 2 diabetes mellitus.   "
228614|NCT00848328|"     RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in     different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab,     can block cancer growth in different ways. Some block the ability of cancer cells to grow and     spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. Giving lenalidomide together with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab     works in treating patients with follicular or small lymphocytic non-Hodgkin lymphoma that has     relapsed or not responded to treatment.   "
228616|NCT00848354|"     The purpose of this 2 phased, open-label study is to compare the safety and efficacy of     etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin     American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a     randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that     allows the investigator to choose continuation with the phase I treatment or the addition,     discontinuation or titration of other DMARD therapy already being utilized for the study.   "
228617|NCT00848367|"     The main objective of the proposed study is to determine whether the effectiveness of a group     therapy treatment for Binge Eating Disorder (BED) is improved and attrition reduced by     optimally matching women with BED who have high attachment anxiety to Group Psychodynamic     Interpersonal Psychotherapy (GPIP). This study represents the next phase in a program of     research stemming from a previously conducted randomized controlled trial (RCT).   "
228618|NCT00848380|"     This practical experience should report a retrospective collection of data regarding     cardiovascular risk factors of cardiovascular diseases. The goal is an evaluation of the     development of the risk profile of cardiovascular patients with simultaneous treatment of     hypertension and hyperlipidemia   "
228619|NCT00848393|"     Cardiac surgery induces a measurable stress response in patients which leads to increased     morbidity and mortality post-operatively. Through clinical observation, anesthesiologists     have determined that varying the combinations of anesthesia drugs used during surgery and     just after reduces the stress response, and by extension, morbidity and mortality. However,     only a few studies have explored this phenomenon scientifically.   "
228620|NCT00848406|"     Smoking induces an inflammatory reaction in the airways which can ultimately result in     persistent damage and the development of a Chronic Obstructive Pulmonary Disease (COPD).     However, not all subjects who smoke end up with COPD. After long-term smoking, approximately     20% of subjects develop COPD. At this time, it is unclear why some subjects develop COPD,     whereas others maintain a normal lung function.      In addition, smoking has important consequences in asthma. Patients with asthma who smoke     have a more severe asthma and more often experience an asthma exacerbation. In addition, it     has been shown that inhaled corticosteroids are less effective in smoking asthmatics.      With this research project, the researchers will investigate the effects of smoking on the     airways. To this end, the researchers will compare markers of airway inflammation, lung     function and symptoms between healthy smokers and non-smokers of varying age. In addition,     the researchers will compare those healthy subjects with patients with asthma and COPD which     are characterized in earlier studies.   "
228621|NCT00848419|"     The aims of this study are to provide pharmacokinetic-pharmacodynamic data to quantify the     analgesic and side effect profiles of epidural methadone, fentanyl and morphine. The     investigators will compare the analgesic effect at three dermatomes to assess the rostral     spread of drug, the investigators will assess plasma levels to assess the systemic     redistribution of drug and the investigators will assess surrogate markers of central opiate     effects (nasal capnography and pupilometry). The investigators hypothesize that due to the     long-duration of action of methadone, and its intermediate lipophilicity, that methadone will     provide a predominantly segmental analgesia of long duration of action, with low rostral     spread and low direct central depressant effects (including respiratory depression).   "
228622|NCT00848432|"     This study set out to determine the duration of maintenance treatment with therapeutic     risperidone dose in schizophrenia. In a multi-center, open label, randomized, controlled     study design, patients with schizophrenia who were clinically stabilized following an acute     episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued     for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks     followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week     group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for     at least another 6 months).   "
246226|NCT01086462|"     This study is a first administration to man microdose study to describe the pharmacokinetics     of GSK2239633.   "
228623|NCT00840489|"     The rate of sustained virological response to a course of standard antiviral therapy     (peg-interferon plus ribavirin) of patients with chronic hepatitis C infected by genotype 1     with advanced fibrosis (>F2) is rather low. Monotherapy with ribavirin reduces ALT levels and     necroinflammatory liver activity in up to a half of non-responders to standard antiviral     therapy, but without changes in liver fibrosis or viremia. Such a beneficial effect seems to     be mainly due to the immunomodulatory effect of ribavirin. Portal pressure, as measured by     HVPG, lowers in patients with chronic hepatitis C and advanced fibrosis with end-of-treatment     response to peg-interferon plus ribavirin. Portal pressure reduction in this setting relates     to a reduction of the necroinflammatory liver activity, but not with fibrosis amelioration.     We hypothesize that monotherapy with ribavirin reduces portal pressure in hepatitis C     patients with advanced fibrosis by means of its immunomodulatory and anti-inflammatory     effects, and could constitute an alternative to non-responders to standard antiviral     treatment. Portal pressure measurement has become a validated surrogate outcome measure in     chronic liver disease, since decreasing portal pressure has shown consistent improvement in     survival and clinical outcomes, such as complications of portal hypertension. The primary aim     of this study is to investigate whether ribavirin monotherapy slows the progression of     advanced chronic liver disease by hepatitis C as assessed by a reduction in HVPG.   "
228624|NCT00840502|"     Most of the neonatal deaths that occur worldwide every year are associated with low birth     weight (LBW), caused by intrauterine growth restriction (IUGR) and/or preterm delivery.     Accurate assessment of fetal growth and gestational age for timely identification and     management of growth restriction are therefore public health priorities, especially in     developing countries where 98% of all neonatal deaths occur. Every year, more than 50 million     women become pregnant in malaria endemic regions. Malaria infection at any time during     pregnancy reduces birthweight. However, little is known about the relationship between the     timing of infection during pregnancy and the extent of the impact on birth weight. The     mechanisms by which malaria causes LBW also remain unclear. Reduced placental blood flow,     placental changes, red blood cell changes, severe anaemia and pro-inflammatory cytokines have     all been implicated.      In this proposed, longitudinal, observational, minimal risk study, which will take place in     SMRU antenatal clinics on the Thai-Burmese border, the effect of malaria infection during     pregnancy on fetal growth will be determined. Women will be screened before 13+6 weeks of     gestation and followed with regular ultrasound examinations during pregnancy. When a woman     has a malaria infection an extra ultrasound scan will be done to measure growth retardation     or placental blood flow changes. Bloodsamples will be taken to detect changes in red blood     cell properties and putative markers of malaria infection. For this study the maximum amount     of blood taken during pregnancy is 13 cc in an uninfected woman. For each malaria episode an     additional 7 cc blood will be taken. After delivery a placenta and a cord sample will be     taken to detect placental changes. The investigators aim to recruit four hundred pregnant     women over the course of two years. This study involves minimal risk to participants as     ultrasound examination is part of routine antenatal care in many countries in the world.   "
228626|NCT00840528|"     The principal purpose of this study is to identify hyper-responsive, responsive and     non-responsive groups of healthy human subjects based on their airway neutrophilic response     to ozone exposure, and to perform micro-array analyses on DNA collected from recovered airway     cells to explore possible differences in gene expression profiles between the three groups   "
228627|NCT00840541|"     The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy     (DR) progression based on available clinical data (demographic, systemic and ophthalmic     data).   "
228628|NCT00840554|"     The purpose of this study is to find out if adding a home exercise program to a clinic     physical therapy program will improve the fatigue experienced by patients being treated with     concurrent chemotherapy and radiation therapy for high grade gliomas.   "
228629|NCT00840567|"     The investigators plan to obtain skin and blood samples from healthy volunteers and patients     with a benign, inherited hematologic disease to use for research to use homologous     recombination to correct β-globin gene mutations in therapeutically useful cells, like     autologous induced pluripotent stem cells from sickle cell anemia patients.   "
228630|NCT00840580|"     The purpose of this study was to compare the effects of Vigamox and Cravit on corneal wound     healing after cataract surgery.   "
228631|NCT00840593|"     The purpose of this study is to compare the long-term clinical and radiological results of     operative and conservative treatment of Tossy type 3 acromio-clavicular dislocation.   "
228632|NCT00840606|"     This study will compare the relative bioavailability (rate and extent of absorption) of 30 mg     Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 30 mg     BUSPAR® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 30 mg     tablet) in healthy adult volunteers under fasting conditions.   "
228633|NCT00840632|"     The objective of this study is to compare the rate and extent of absorption of trandolapril     from a test formulation of Trandolapril 4 mg Tablets versus the reference Mavik® 4 mg Tablets     under fasting conditions.   "
228634|NCT00840645|"     The study is intended to test the safety, tolerability, and efficacy of long-term treatment     with YM178 in patients with overactive bladder symptoms.   "
228635|NCT00840658|"     The investigators propose a highly efficient four-arm (factorial) trial to simultaneously     test the efficacy of two behavioral interventions aimed at:        -  increasing condom use in the context of ongoing drug use and        -  decreasing needle and paraphernalia sharing      among female sex workers who also inject drugs in two Mexican-U.S. border cities: Tijuana and     Ciudad Juarez.   "
228636|NCT00840671|"     It should be shown that Cerebrolysin in combination with Alteplase, the medication that     should recover the blood flow through the brain, is an effective and save medication to treat     ischeamic stroke.   "
228637|NCT00840684|"     RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, and cytarabine,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of laromustine when     given together with daunorubicin and cytarabine in treating patients with acute myeloid     leukemia.   "
228651|NCT00840866|"     The objective of this study is to compare the relative bioavailability of cefprozil 500 mg     tablets with that of Cefzil 500 mg tablets in healthy, non-smoking adults under non-fasting     conditions.   "
228652|NCT00840879|"     The objective of this study is to compare the rate and extent of absorption of meloxicam from     a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under     fed conditions.   "
229202|NCT00853372|"     This phase 2 study is an open-label, multi-center study to determine the safety and     tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with     metastatic renal cell carcinoma.   "
228638|NCT00840697|"     Low back pain is a usual condition in the western countries and several treatments available     for patients with non-specific low back pain. According to the European guidelines both     Brief intervention and exercise/cognitive intervention are effective treatments with regard     to pain and function (www.backpaineurope.org), but none have documented effect on return to     work.      The challenges for health personnel is not cure of the patients back pain, but to build up     rehabilitation programs which focus on disability and work incapacity, in patients which are     at risk of loosing their work. Dr. P. Loisel, Montreal, Canada, has since 1995 treated     patients with back pain according to the The PREVICAP model - (PREVention of work     handICAP), where the main purpose with work-related program is to prevent prolonged     disability and to help patients back to work. Loisel demonstrated that the PREVICAP models     accelerated the return to work factor by a factor 2.4 (p=0.01). The PREVICAP model had also     been evaluated in Amsterdam, by Dr. Anema with the same results.      At the Back Clinic, Ullevål University Hospital we are presently involved in a randomized     controlled trial after the PREVICAP model, where patients are randomized to Brief     intervention including a work-related intervention or usual care. All included patients in     both groups, will have a clinical examination by specialist in Physical Medicine and     Rehabilitation and advice from a physiotherapist. The current study replaces Brief     intervention with an exercise - and a work-related program, so patients with non-specific LBP     will be randomized to an exercise and work-related program or usual care.      The main purpose of this study        -  to investigate if rehabilitation programs specifically focusing on the return to work          process will reduce sickness absence and disability pension in patients with neck and          low back pain.        -  to assess the work-, individual- and health factors and their interrelationship          predicting sickness absence and work disability.        -  to compare results from the rehabilitation program with results from rehabilitation          program in Toronto        -  to which extent are the patients met by actions from employers and employment services,          and does is influence sickness absence and disability.        -  do these actions represent favourable cost benefit for the work places and the society   "
228639|NCT00840710|"     The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow     contraction in a women in active labor.   "
228640|NCT00840723|"     The purpose of this research study is to collect cells and liquid from the air passages of     healthy adults, both smokers and non-smokers. These samples will be used for test-tube     studies to explore mechanisms of diseases of the respiratory tract, and to compare the     samples between people who smoke cigarettes and people who don't. Obtaining these samples     requires an invasive procedure called bronchoscopy.   "
228641|NCT00840736|"     The study aims to investigate the long term results of a randomized clinical single-centre     trial comparing two standard operative techniques in bariatric surgery; laparoscopic     adjustable gastric banding and vertical banded gastroplasty.   "
228642|NCT00840749|"     Lung cancer remains the most frequent cause of cancer death in both men and women in the     world. Surgical resection using lobectomy with mediastinal lymph node dissection or sampling     has been a standard of care for operable early stage NSCLC. Several studies have reported     high local control and survival using SBRT in stage I NSCLC patients. SBRT is now an accepted     treatment for medically inoperable patients with stage I NSCLC and patients with operable     stage I lung cancer are entered on clinical protocols. The purpose of this study is to     conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the current     standard of care for stage I operable NSCLC.   "
228656|NCT00840931|"     The purpose of this study is to find out the maximum tolerated dose (MTD) of the combined     therapy of lenalidomide (Revlimid®) and Granulocyte/macrophage colony stimulating factor and     CD40 Ligand expressed in the K562 cell line (GM.CD40L) bystander vaccine. This research is     also being done to see how well the combination of these drugs works to fight myelodysplastic     syndrome (MDS).   "
228643|NCT00840762|"     The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to     those provided by local expert review. The investigators propose that clinic patients of the     Ruth M. Rothstein CORE Center who are having genotypic testing performed will be randomized     in a 1:1 fashion to local expert review and to Virco®TYPE HIV-1. Results of either method     will be shared with primary HIV care providers. Patient outcomes will be reviewed at a time     point equal to or greater than 2 months and 6 months following the change in antiretroviral     medications following the testing   "
228644|NCT00840775|"     The purpose of this study is to collect and analyze additional information about the safety     and effectiveness of the Presillion™ Stent System in the treatment of de novo stenotic     lesions in native coronary arteries.   "
228645|NCT00840788|"     Surgical repair of perineal lesions after delivery is frequently associated with pain and     discomfort interfering with the normal activities of the puerperium. The aim of this study     was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular     suture, regarding the incidence of pain and wound complications.   "
228646|NCT00840801|"     The objective of this study is to assess the immunogenicity, safety and interchangeability of     two different TBE vaccines in children aged 1-11 years, the first and second vaccination with     either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with     FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28     and 360 days).   "
228647|NCT00840814|"     RATIONALE: Developing a symptom checklist for late-effect lymphedema may help doctors learn     more about lymphedema in patients with head and neck cancer and plan the best treatment.      PURPOSE: This phase I/II trial is developing a checklist of lymphedema symptoms in patients     with head and neck cancer.   "
228648|NCT00840827|"     Lenalidomide has shown significant efficacy in the treatment of anemia associated with both     5q- and non 5q- MDS patients. The mechanism(s) of action of lenalidomide in MDS is still to     be determined, but given the differences in response rates seen, it is probable that the     mechanism is different for patients with 5q- disease compared to non 5q- patients. T-cell     mediated activation of intramedullary apoptosis in patients with early MDS leading to     impaired hematopoiesis has been well described. Immunomodulation with agents such as ATG,     cyclosporine and thalidomide have demonstrated clear activity in some patients with MDS.     Lenalidomide, among its many effects, is a potent immunomodulator, which may contribute to     its ability to improve red blood cell counts in patients with MDS. It is possible that this     effect could be augmented with the addition of cyclosporine A (CSA), in a similar manner to     CSA effects in patients with other bone marrow failure syndromes such as aplastic anemia.      Subjects will be treated with lenalidomide 10 mg PO daily days 1-28 of a 28-day cycle.     Cyclosporine A will be started on day 1 of cycle 2 (day 29) at a dose of 5 mg/kg per day     given orally in 2 divided doses. Cyclosporine A levels will be assessed weekly and doses will     be adjusted to maintain a serum trough level between 100-450 mg/ml. Patients will continue on     therapy for minimum of 16 weeks unless toxicity occurs which precludes continuation on     therapy, disease progression and/or patient withdrawal of consent. Patients not achieving     response after completing 16 weeks of therapy will discontinue treatment. Patients achieving     response will continue therapy until disease progression, unacceptable toxicity or loss of     response.   "
228653|NCT00840892|"     There is growing evidence that COPD is a multi-organ system disease. Besides impaired lung     function, skeletal muscle weakness and weight loss are important determinants of impaired     exercise performance, decreased quality of life and increased mortality. Based on earlier     succesful intervention studies in pulmonary rehabilitation settings, Máxima Medical Centre     developed an integrated, inter-disciplinary approach to the management of COPD including     physical exercise, nutritional therapy, education, smoking cessation and psychological     consultation. This COPD management program consists of a set of protocols that cover patient     recruitment, diagnostic testing, treatment, follow-up and communication between     professionals.      The exercise program and the nutitional therapy are carried out by local physiotherapists and     dieticians working outside but in conjunction with the hospital. A program in such a setting     could be substantially less expensive and certainly more easily accessible for many more     patients than an inpatient or hospital-based outpatient rehabilitation program, as it is     offered close to a patient's home. This study investigates the (cost-)effectiveness of the     COPD management program compared to usual care in a randomized controlled trial.      Patients with moderate to severe COPD and a reduced exercise capacity during an incremental     exercise test of less than 70% of predicted, are randomised to a treatment or a control     group. The treatment group will participate in the COPD management program during the first 4     months after which they will be followed up for the remaining months. Both groups (n=100) are     followed for 2 years and outcomes will be assessed at the beginning of the program, after 4,     12 and 24 months by disease-specific and generic measures of health status, body composition,     skeletal muscle function and exercise capacity. A cost-effectiveness and cost-utility     analysis with a two-year time horizon will be performed. The analysis is conducted from a     societal perspectice, including the program costs and all COPD-related direct costs within     and outside the healthcare sector ans costs of lost productivity.   "
228654|NCT00840905|"     This is a study to determine what Human Papillomavirus HIV seropositive women in Botswana,     South Africa and Brasil have been exposed to during their life. The Human Papillomavirus     causes cervical cancer. Different types are more likely to lead to cancer than other types. A     vaccine has been made to fight infection against HPV 16 and 18 which has been shown to cause     cervical cancer in America and Europe. What HPV type cause cancer in other countries is not     as well studied.      Hypothesis HPV serology will demonstrate that exposure to each HPV type in Gardisil     (6,11,16,18) will be <50% in HIV seropositive women in resource limited countries.   "
228655|NCT00840918|"     This study is being done to determine if lidocaine, administered during surgery and for 24     hours after surgery can reduce inflammation, thereby reducing the risk of atrial fibrillation     and 30 day mortality after surgery. Participants undergoing cardiac surgery will be     randomized to receive either lidocaine or placebo.   "
228669|NCT00841113|"     To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients     with advanced or metastatic prostate cancer.   "
228657|NCT00840944|"     Estrogens are responsible for the disappearance of growth cartilage in the long bones at the     end of the pubertal growth spurt both in boys and in girls. It is therefore hypothesized that     stopping pubertal development and hence estrogen production, will prolong and increase the     pubertal growth spurt, especially when growth hormone is given concommitantly.      Boys in early puberty, with a bone age between 11 and 13 years and a predicted adult height     below 163 cm or girls in early puberty with a bone age between 10 and 12 years and a     predicted height under 151 cm will be treated with triptorelin 3.75 mg and Zomacton growth     hormone for 4 years.   "
228658|NCT00840957|"     Infliximab is a chimeric monoclonal antibody directed towards Tumor Necrosis Factor -alpha     that is largely used in inflammatory diseases such as rheumatoid arthritis (RA).      A relationship between dose and clinical outcomes was shown in populations of RA patients but     there is an interindividual variability of this relationship. At an individual level, this     dose-effet relationship can be separated into the dose-concentration (pharmacokinetic or PK)     and the concentration-effet (pharmacokinetic-pharmacodynamic or PK-PD) relationships.      Serum trough concentrations of infliximab have been shown to be variable between patients     receiving the same treatment regimen. This PK variability may be explained by several factors     (e.g. genetic and immunological factors). The concentration-effect relationship may also be     variable and the sources of this variability need to be studied as well. To date no detailed     infliximab PK analysis has been published. The sources of variability of the dose-effect     relationship need to be characterized to optimize infliximab dosing regimen in patients.      The FAKIR study is a multicenter prospective observational study that will focus on patients     treated with infliximab. Its aims are:        1. to characterize the PK and PK-PD variability of infliximab in RA, using clinical          criteria and biomarkers, assessed over time ;        2. to study the influence of the polymorphism of FCGRT (the gene encoding FcRn) on the PK          variability of infliximab; to study the influence of the polymorphism of FCGR3A (the          gene encoding Fc gamma RIIIa) on the PK-PD variability of infliximab; and to study the          influence of antibodies toward infliximab on the PK and PK-PD variabilities of          infliximab.   "
228659|NCT00840983|"     The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds     would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better     motor function at 40 wks and 7 months of age.   "
228660|NCT00840996|"     The purpose of this study is determine if epidural anesthesia administered after surgery or     lidocaine administered during surgery will decrease inflammation after spinal surgery and     decrease the need for post operative pain medication compared to intravenous patient     controlled analgesia. Participants undergoing spine surgery will be randomized into one of     two groups;      - A.) General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV     infusion.      B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative     Patient Controlled Analgesia.   "
228661|NCT00841009|"     Obesity affects more than 43 million Americans and is associated with an increased incidence     of heart failure, sudden death, and cardiovascular death. We have shown that increasing     obesity is independently associated with potentially detrimental LV structural and     functional, and metabolic changes. Thus in order to increase our understanding of the effect     of obesity on the heart, we wish to study the effect of significant weight loss on these     parameters.   "
228662|NCT00841022|"     This study aims to investigate whether detailed and illustrated information (comics) about     anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.      Children scheduled for craniotomy are randomized to groups receiving a comic leaflet     explaining the course of anaesthesia before preanaesthesia visit or no intervention.      Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.   "
228853|NCT00849680|"     The goal of this study is to understand the safety, tolerability and immunogenicity of the     Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef      Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared to placebo.     The study will also evaluate a number of dose levels and the necessity for and timing of     booster injections.   "
228663|NCT00841035|"     1.1 Primary Objective      To evaluate the effects of short course preoperative erlotinib treatment in a panel of     predictive biomarkers from a group of patients who undergo resection of pancreatic     adenocarcinoma with curative intent.      1.2 Secondary Objectives      1.2.1 To analyze the effects of short course preoperative erlotinib treatment followed by     postoperative erlotinib-gemcitabine therapy in the disease-free survival of patients who     undergo curative intent resection of pancreatic adenocarcinoma.      1.2.2 To evaluate secondary endpoints of disease response such as duration of overall     survival and patterns of recurrence for patients with resectable pancreatic cancer who     undergo this treatment regimen.      1.2.3 To evaluate the plasma pharmacokinetics of erlotinib in pancreatic cancer patients both     in the preoperative and postoperative setting, and to explore correlations between plasma and     tumor erlotinib concentrations.      1.2.4 To develop a clinically relevant predictive assay of response to erlotinib based on     selected biomarkers in endoscopic ultrasound-fine needle aspiration (EUS-FNA) specimens when     it can be obtained at the time of pancreatic cancer diagnosis in chemotherapy-naive patients.   "
228664|NCT00841048|"     The primary aim of this study is to investigate the safety and tolerability of AZD4017 when     given as multiple oral ascending doses to healthy volunteers. This will be done by comparing     the effect of AZD4017 to placebo. The study will aslo investigate the absorption,     distribution and disappearance of AZD4017 in the body. Information about plasma     concentrations of AZD4017 vs time after dose intake will also be collected and some measures     of pharmacokinetics versus pharmacodynamics will be included. The future indication for     AZD4017 is planned to be Type 2 Diabetes Mellitus.   "
228665|NCT00841061|"     The purpose of this research study is to determine whether the type of iron in infant cereals     makes a differance in how well the cereal helps infants remain free of iron deficiency.   "
228666|NCT00841074|"     The purpose of this study is determine if topical oral application of a chlorhexidine     antimicrobial spray will significantly reduce pneumonia and respiratory infections, and     improve oral health compared to a placebo solution in nursing home residents.   "
228667|NCT00841087|"     This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety     (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or     intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in     subjects with type 1 diabetes mellitus.   "
228668|NCT00841100|"     The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness     in the same patients with PKU when their blood phenylalanine concentrations are altered by     diet.      Lowering blood phenylalanine concentrations in Kuvan non-responsive patients with PKU will     increase the frequency of Kuvan responsiveness.   "
228670|NCT00841126|"     Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food,     reducing the amount that the body can absorb.      The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in     subjects requiring hemodialysis, compared with a marketed phosphate binder, lanthanum     carbonate and placebo.   "
228671|NCT00841139|"     Conventional measures used for the treatment of chronic heart failure act predominantly by     reducing the work performed by the heart. In a recent study, the investigators showed that     one drug (perhexiline) substantially improved symptoms and cardiac function in heart failure.     The investigators wish to confirm these findings and test whether or not this drug acts by     altering the heart's energy source thus augmenting the energetic status and work efficiency     of the heart.   "
228672|NCT00841152|"     This study is designed to perform a head-to-head comparison of two synthetic ceramic bone     graft substitutes, bioactive glass (BAG) and beta-tricalcium phosphate (TCP), in filling of     contained bone defects following surgical evacuation of benign bone tumor or tumor-like     conditions. Based on the investigators' previous preclinical research and an ongoing     single-center randomized clinical trial on bioactive glass filling, the investigators expect     BAG filling to be more efficient compared to TCP in promotion of defect healing and     functional recovery after surgery.   "
228673|NCT00841165|"     Carbon monoxide (CO) has been called a silent killer, and those patients who survive CO     poisoning are at risk of neurological damage, which may be permanent. CO is a leading cause     of unintentional poisoning deaths in the United States, and the odorless gas results in an     estimated average of 20,636 emergency department (ED) visits each year. Oxygen is the     antidote for CO poisoning, and it acts both by attenuating toxic effects and enhancing     elimination. A fractional inspired concentration of oxygen (FiO2) of 0.7 to 0.9 may be     achieved by administration of 100% oxygen delivered using a reservoir with a facemask that     prevents rebreathing. Hyperbaric oxygen therapy may provide added benefit for patients with     CO poisoning, but this therapy is unavailable in many parts of the United States including     Vermont. Use of a continuous positive airway pressure (CPAP) mask may achieve an FiO2 of 1.0,     but the effects of delivering an FiO2 of 1.0 compared to 0.7 in CO poisoning are unknown.     CPAP, by comparison, is inexpensive, portable, and available in most EDs. In this study, the     investigators are testing the hypothesis that oxygen delivered by CPAP will improve both CO     washout kinetics and functional outcomes, compared to the standard therapy of oxygen     delivered by non-rebreathing facemask. Specific Aim 1 will provide toxicokinetic data to     support a potential benefit in the use of CPAP for CO poisoning, by comparing CO elimination     kinetics in response to oxygen therapy delivered by non-rebreathing facemask versus CPAP. The     20 patients expected in our first year will provide adequate power to detect a 20% fall in     half-time of CO elimination. While CPAP may increase CO washout rates, as predicted in     Specific Aim 1, demonstration of real functional benefit will be tested in Specific Aim 2.     This Aim seeks to determine functional (neuropsychological) outcomes in patients with CO     poisoning treated with oxygen therapy delivered by non-rebreathing facemask versus CPAP. Data     showing a therapeutic benefit from CPAP in CO poisoning would have clinical implications.     Compared to hyperbaric oxygen therapy, CPAP therapy can begin earlier, including the     pre-hospital setting, for patients with known exposure. With the frequent nature of CO     poisoning and the widespread availability of CPAP, a potential benefit could lead to improved     outcomes for the 20,000+ patients who present to EDs annually.   "
228693|NCT00841425|"     Previously the investigators have found that adolescent elite swimmers, who have been     involved in competitive swimming for only a few years, have not developed respiratory     symptoms, signs of airway inflammation or airway hyperresponsiveness exept for a slight     increase in airway responsiveness to eucapnic voluntary hyperpnea. In the current study, the     investigators will be doing a 3-year follow-up study on the swimmers studied previously.   "
228696|NCT00841464|"     The purpose of this research study is to test the usefulness of external magnetic stimulation     (EMS) for treating the motor, cognitive, and neuropsychiatric symptoms of Parkinson's disease     (PD).      Participants with Parkinson's disease will be recruited at the PADRECC of the Philadelphia VA     Medical Center. Enrolled participants will be randomly assigned to receive either active     external magnetic stimulation or fake stimulation. The external magnetic stimulation is     delivered by wearing a helmet that is embedded with many small circuits which produce a very     small magnetic field around the head. The helmet is to be worn daily for two minutes     immediately before bedtime for three months in a row. The helmet is for investigational use     only and has not been approved for use by the FDA.   "
228674|NCT00841178|"     Varicose veins are a common problem, affecting up to a third of the western adult population.     Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications     include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is     known to have a significant negative effect on patient's quality of life (QoL).      Surgery has been used for many years, but it is known that there is a temporary decline in     QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged     recovery in some patients and has the risks of infection, haematoma and nerve injury.      Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated     persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at     34 years.      26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.      Newer, less invasive treatments are being developed. It would be advantageous to find a     treatment that avoided the morbidity of surgery, one that could be performed as a day-case     procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and     allow an early return to work. These should be the aims of any new treatment for varicose     veins.      Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser     energy delivered into the vein to obliterate it. The vein therefore need not be tied off     surgically and stripped out.      The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery     and EVLT.   "
228675|NCT00841191|"     The purpose of this study is to determine the recommended dose of siltuximab monotherapy, in     participants with solid malignant (cancerous) tumors (a mass in a specific area) and to     estimate the clinical benefit of siltuximab monotherapy in participants with ovarian cancer     and with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant tumors.   "
228676|NCT00841204|"     This randomized phase II trial is studying how well sulindac works in preventing melanoma in     healthy participants who are at increased risk of melanoma. Sulindac may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known     whether sulindac is more effective than a placebo in preventing melanoma in individuals with     many moles and abnormal moles.   "
228677|NCT00841217|"     The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable     effect on lipoprotein metabolism.   "
228678|NCT00841230|"     The purpose of this study is to investigate whether increased tinnitus reduction can be     obtained with Deanxit in patients already receiving Rivotril.   "
228679|NCT00841243|"     Standard antiviral treatment consists of weekly injections with Peginterferon-α in     combination with ribavirin. This treatment may lead to significant weight loss (7% within 24     weeks on average), with decreased quality of life. In this study the investigators will     examine in 50 patients whether nutritional advise and support can prevent weight loss during     antiviral therapy.   "
228680|NCT00841256|"     Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens     formulated as solution in comparison to a symptomatic standard treatment with add on placebo     in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with     or without bronchial asthma.   "
228719|NCT00841763|"     The present study, phase III, randomized, controlled, observer-blind, multicenter study, will     evaluate safety, tolerability and immunogenicity of two doses of an adjuvanted monovalent     influenza vaccine compared with an adjuvanted interpandemic trivalent influenza vaccine in a     population of healthy adult and elderly subjects.   "
228720|NCT00841776|"     The purpose of the study is to determine the development of microbial resistance when using     one of two topical acne therapies for the treatment of facial acne vulgaris.   "
228721|NCT00841789|"     The purpose of this study is to determine whether Etanercept (Enbrel) when used in     conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with     Kawasaki Disease. Funding Source- FDA/OOPD   "
228681|NCT00841269|"     The purpose of the study is to see if the investigational medication uridine reduces     depression symptoms in adolescents with bipolar disorder. Uridine is a naturally occurring     chemical that is made by the human liver. Uridine is part of a family of compounds called     pyrimidines, and is normally involved in many of the body's processes such as the use of     energy by cells. Uridine is considered experimental, because it has not been approved by the     U.S. Food and Drug Administration (FDA) to treat bipolar depression in adolescents. The study     will use standard methods of assessing adolescent's mood, such as rating scales and     questionnaires. In addition, the study will use Magnetic Resonance Imaging Spectroscopy     (MRI/MRS) brain scans to see if levels of certain chemicals in the brain change when     adolescents are treated with uridine. These scans use a magnet to create images of the brain,     and do not expose patients to radiation.   "
228682|NCT00841282|"     Our aim is to perform a randomized-controlled trial comparing air insufflation sedated     colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by     supervised trainees. Randomized trials demonstrating reduced need for sedation medications     without compromising patients' comfort, cecal intubation rates or polyps detection may cause     a paradigm shift and positively alter the way traditional colonoscopy is performed and future     endoscopists are trained.   "
228694|NCT00841438|"     The ADMIRAL (Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute     myocardial infarction) study demonstrated that early administration of abciximab in patients     with ST elevation acute myocardial infarction prior to PCI improves clinical outcomes but no     specifically designed randomized study has addressed the issue of early upstream use of GP     IIb/IIIa inhibitors in ST elevation acute myocardial infarction who are undergoing PCI,     especially in the era of routine pretreatment with 600 mg of clopidogrel. Therefore, the     objective of the randomized ECLAT-STEMI study was to assess the hypothesis that the early     upstream use of Clotinab is a useful therapy in patients with ST elevation MI undergoing PCI     compared to provisional use, even after pretreatment with a 600-mg loading dose of     clopidogrel.   "
228695|NCT00841451|"     Fish oil therapy may decrease the incidence of cardiac arrhythmias. This study will test     whether pre-treatment with fish oils before catheter ablation of atrial fibrillation     decreases the early post operative occurrence of atrial fibrillation.   "
228714|NCT00841698|"     The objective of this study is to compare the rate and extent of absorption of paroxetine     hydrochloride 40 mg film-coated tablets (test) versus Paxil® (reference) administered as 1 x     40 mg film-coated tablet under fasting conditions.   "
228683|NCT00841295|"     Background: Carnitine is the essential cofactor for various enzyme activities of human     metabolism, especially for the mitochondrial carnitine shuttle that transfers long-chain     fatty acids as acylcarnitine esters across the inner mitochondrial membrane for     Beta-oxidation and energy production. Intracellular carnitine deficiency induces an     impairment of long-chain fatty acid oxidation. In human, approximately 75% of carnitine comes     from the diet and 25% from endogenous liver synthesis. In the neonatal period, more     specifically in the premature, liver synthesis capacity is reduced because of immaturity of     the biosynthetic pathway, and carnitine levels are related to exogenous sources.     Traditionally, carnitine is not added to parenteral nutrition. Indeed, without enteral feeds     and carnitine supplementation of parenteral nutrition, preterm infants' plasma carnitine     levels fall during the first weeks of life, particularly in subjects requiring a prolonged     exclusive parenteral nutrition. The potential deleterious role of carnitine deficiency has     not been clearly demonstrated in these infants. However, most patients with primary carnitine     deficiency, a genetic defect of carnitine transport inducing a severe carnitine deficiency,     commonly develop liver symptoms (encompassing visceral steatosis, hyperammonemia and     recurrent hypoketotic hypoglycemias) and/or cardiomyopathy and myopathy. In these latter     patients, carnitine supplementation improves all the symptoms.      Hypothesis: Carnitine deficiency of the premature and very low birth weight infants may be     one of the factors involved in the liver disease frequently associated with prolonged     parenteral nutrition, and may have deleterious effects on cardiac and muscle metabolism and     functions.      Aims: To demonstrate beneficial effects of parenteral carnitine supplementation in premature     neonates for liver, heart and muscle metabolism and functions.      Study Type: Multicentric prospective and randomised study      Subjects: Premature and very low birth weight neonates, defined by gestational age minor or     equal to 28 weeks and/or birth weight minor or equal to 1000 grams, 80 subjects will be     enrolled during 2.5 years      Interventions: Arm 1 (experimental): parenteral carnitine supplementation (9 ± 1 mg/kg/d),     from day 4, until than enteral nutrition provides sufficient carnitine source; Arm 2 (Placebo     comparator): parenteral supplementation with an equivalent volume of sterile water.   "
228684|NCT00841308|"     This is a prospective randomized study with two arms: the Conventional and Ambulatory blood     pressure monitoring arm and the Home blood pressure monitoring arm. The study will include     both previously treated and untreated individuals.      Before randomization and in the end of the study, measurements will be performed using all     three blood pressure monitoring methods (Conventional, Ambulatory and Home) as well as     assessment of target organ damage (microalbuminuria, electrocardiogram, echocardiogram,     carotid-femoral pulse wave velocity and central blood pressure).      The participants will be randomized into one of the two arms. Diagnosis and titration will be     decided according to either Conventional and Ambulatory blood pressure measurements or     according to Home blood pressure measurements. Subjects will be followed up for one year.   "
228685|NCT00841321|"     The purpose of this study is to see if treatment with Ginkgo improves cognitive function in     people with multiple sclerosis who have cognitive problems.   "
228686|NCT00841334|"     Community based participatory research principles will be used to create, implement and     evaluate a culturally relevant and age-appropriate obesity intervention for adolescents who     are overweight or obese. The intervention will be implemented through school-based health     centers (SBHC) and will include clinical encounters with SBHC providers, use of Motivational     Enhancement Therapy to help overweight/obese adolescents adopt healthier behaviors, and use     of a community advisory council to develop obesity risk reduction strategies that will be     delivered by print and digital video disc (DVD) media. To test efficacy of the ACTION     intervention, overweight/obese adolescents will be recruited to either the intervention     condition or the usual care condition. Students will have pre- and post- intervention     measurements to assess if adolescents in the intervention condition will have improved risk     factor profile for metabolic syndrome, improved nutrition and increased physical activity     when compared with students in the usual care condition.   "
228687|NCT00841347|"     This study aims to investigate        1. whether sleep extension results in improvements of endocrine and metabolic markers of          obesity and diabetes in obese teenagers,        2. the relationship between habitual sleep quality and duration and markers of obesity and          diabetes in lean and obese teenagers.   "
228688|NCT00841360|"     This is a pilot study with a cross-sectional research design to recruit Hispanic/Latina and     African American adolescent and young adult women, aged 13-24 years to serve as index     recruiters, who will in turn recruit members of her female friendship network, aged 13 years     and older to undergo HIV screening. This approach seeks to identify new HIV infections in the     target population.   "
228689|NCT00841373|"     The object of the study is to compare treatment of iris/angle neovascularization with     panretinal photocoagulation (laser) to treatment with panretinal photocoagulation and an     anti-angiogenic drug: ranibizumab.   "
228690|NCT00841386|"     The purpose of this study is to determine the effectiveness of collagen cross-linking in the     cornea in halting the progression and possibly partially reversing the effects of     keratoconus. Keratoconus is a progressive weakening in the cornea that causes irregular     astigmatism and thinning of the cornea. The overall effect is reduction of vision, and in     more advanced cases, scarring of the cornea that may lead to the need for corneal     transplantation. Cross-linking has been shown increase the rigidity of the cornea. The     patients would be treated once and then followed over 24 months. .   "
228691|NCT00841399|"     The purposes of this study are the following:        1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75)        2. To determine maximum tolerated dose (MTD) and optimal biologic dose (OBD) for the          peptide vaccine        3. To evaluate the in vivo cellular immune response to the peptide vaccine        4. To evaluate time to recurrence in the vaccinated patients vs. matched controls   "
228692|NCT00841412|"     Background: Numerous studies have shown that many LTC residents receive inadequate staff     assistance with eating, which places them at risk for under-nutrition, dehydration and weight     loss. Moreover, improvements in feeding assistance care have been shown to improve residents'     daily food and fluid consumption and weight loss outcomes.      Objectives: The purpose of this program evaluation project is to train indigenous LTC staff     how to improve nutritional care within the constraints of existing staffing resources.      Methods: A multiple baseline design was used to evaluate the effectiveness of the program in     one federal and one state VA LTC facility. Research staff collected baseline measures related     to nutritional care processes and resident outcomes. All LTC units in each of the two sites     were divided into two groups for program implementation. The program was implemented with     staff and residents on the units in the immediate intervention group; while, the delayed     intervention group remained in usual care and continued to be monitored monthly for all care     process and resident outcome measures.      Status: This project ended 10/1/13. Five published papers resulted from this study.   "
228854|NCT00849693|"     The purpose of this study is to assess whether duloxetine is superior to placebo in the     treatment of children and adolescents with major depressive disorder (MDD)   "
228697|NCT00841477|"     The goal of the proposed study is to use the HBV vaccine as a model for a future HIV vaccine     trial, examining the efficacy of community-based outreach intervention as well as an     accelerated vaccine schedule as a method for increasing acceptance/adherence with HBV     vaccination protocols among not-in-treatment drug users. This study will also examine the     effect of HBV vaccination coupled with community-based outreach intervention on reducing the     incidence of HIV, HBV and HCV infections and the frequency of needle use and sexual risk     behaviors related to these viral transmissions. A secondary purpose will be to assess the     antibody response after HBV vaccination as a measurement of immunological response in drug     users.   "
228698|NCT00841490|"     The purpose of this study is to determine if the bacteria that cause gastric infections can     be found in the mouths of intellectually and developmentally disabled persons. If the     bacteria that causes gastric infections is found in the mouth it may be swallowed and     contribute to gastric infections.   "
228699|NCT00841503|"     Bioactive components in buckwheat enhance insulin sensitivity in Type 2 diabetes by improving     glucose uptake and utilization through a unique mechanism that operates independent of     insulin.   "
228700|NCT00841516|"     This trial is performed for the immunological and histological evaluation of specific     immunotherapy with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of     the major birch pollen allergen, rBet v1-FV   "
228701|NCT00841529|"     The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to     occlude the LAA   "
228702|NCT00841542|"     The objective of this study is to compare the rate and extent of absorption of amlodipine     from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc®     10 mg Tablets under fasting conditions.   "
228703|NCT00841555|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy     that delivers a high dose of radiation directly to the tumor may kill more tumor cells and     cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may     kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when     given together with radiation therapy in treating patients with newly diagnosed glioblastoma     multiforme or anaplastic astrocytoma.   "
228704|NCT00841568|"     Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral     administrations at doses of 15 mg twice daily in patients with ADPKD who completed the     preceding dose-finding study (156-04-001).   "
228705|NCT00841581|"     Patients with Pigment Epithelial Detachments secondary to Age-Related Macular Degeneration     (AMD) will receive intravitreal Lucentis monthly for 6 months in the hope of improving visual     acuity from a baseline evaluation.   "
228706|NCT00841594|"     The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical     cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.   "
228707|NCT00841607|"     Pancreaticoduodenectomy (PD or Whipple procedure) involves the removal of the head of the     pancreas and is the primary modality for treatment of peri-ampullary cancers (arising from     the common bile duct, Ampulla of Vater, duodenum, neuroendocrine cells of the pancreas, and     most commonly the exocrine pancreas). In Canada, cancer of the pancreas is the 11th cancer in     terms of new cases/year, and the 5th leading cause of cancer related deaths/year. Following     PD the remaining pancreas is re-connected to a portion of the gastrointestinal tract; the     pancreas is very soft and difficult to sew and connect safely. The primary cause of     complications following PD is related to leak occurring at this connection. Of patients that     develop a leak, over half need a second operation, and up to 40% will die. The two main     organs that the pancreas may be re-connected to are the jejunum or the stomach. The     investigators will compare the rates of pancreatic leakage in two groups of patients     randomized to reconnection to either the jejunum or stomach following PD. The goal of this     study is to determine which of these methods is safer. The results may change practice     patterns across North America and the world. It may in the future prevent many cases of     avoidable leakage and the resulting morbidity of this including death. This will therefore     reduce the morbidity and mortality of this group of cancer patients.   "
228708|NCT00841620|"     Background: In an international randomised controlled trial we studied how patient     self-reported symptoms improved after either a stapled anopexy operation or a diathermy     excision of the haemorrhoids.      Methods: The study involved 18 hospitals in Sweden, Denmark and the UK. Two hundred and seven     patients were randomised. After exclusion of 27 patients, 90 in both groups were operated and     followed one year. Patients provided self-reported symptoms before surgery and after 1 year.     A patient diary obtained daily self-reported postoperative pain scores (VAS). Surgeons     evaluated the anal anatomy before surgery and after 1 year.   "
228709|NCT00841633|"     The purpose of this study is to test the feasibility of a trial on induced hypertension to     improve neurological outcome in patients with subarachnoid haemorrhage that developed the     serious complication delayed cerebral ischemia, and to assess whether induced hypertension     results in improved cerebral blood flow (CBF) as measured by means of perfusion-CT.   "
228710|NCT00841646|"     The present study will evaluate the immunogenicity, safety and tolerability of two doses of     monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a     surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult and Elderly     Subjects.   "
228711|NCT00841659|"     The objective of this study is to compare the rate and extent of absorption of paroxetine     hydrochloride 40 mg film-coated tablets (test) and Paxil® (reference) administered as 1 x 40     mg film-coated tablet under fed conditions.   "
228712|NCT00841672|"     This study will compare the blood pressure (BP) lowering effect of the combination of     aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate     to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine     produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP)     after 8 weeks of treatment.   "
228713|NCT00841685|"     Implantation of fiducial markers in the prostate and daily check of the positioning during     radiotherapy based on the implanted fiducial markers   "
228715|NCT00841711|"     TRANSITIONS, a novel jail-release program for People Living with HIV/AIDS (PLWHA), will use     evidence-based interventions and adapt them to create a comprehensive transitional program in     Waterbury and New Haven County, Connecticut. Evidence-based interventions will include, but     not be limited to, enhanced rapid HIV testing within the New Haven Community Correctional     Center (NHCCC, local jail), intensive case management, continuity of buprenorphine treatment     from the jail to the community setting and a novel Money Management (MM) program.      The HIV in Prisons Program and the Community Health Care Van (CHCV) at the Yale University     AIDS Program, in collaboration with the Connecticut Department of Correction and the     Waterbury Hospital Infectious Diseases Clinic, propose to expand the availability of opiate     substitution treatment and to enhance clinical and social services for PLWHA, who are     transitioning from the jail to the community setting.      As part of Transitions, we will develop a model Money Management program that we have used in     community settings to improve health outcomes for socially and medically marginalized     populations and adapt it for a jail-release program. The Transitions program will incorporate     these elements into a combined intervention and will result in a clinical trial to compare     the additional contribution of a money management program.   "
228716|NCT00841724|"     The goal of this prospective study is to assess the overall mortality (whether related to     relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell     transplantation prepared by a so-called reduced-toxicity submyeloablative conditioning     regimen in patients with hematological malignancies.   "
228717|NCT00841737|"     The purpose of this study is to compare the effectiveness and efficiency of doing a     psychoeducational group program and the conventional treatment versus individual conventional     care in patients with a mild/moderate depression disorder,in urban primary healthcare centers     in Barcelona city.   "
228718|NCT00841750|"     After performing VATS pulmonary wedge resections, a chest tube is routinely left in the     pleural cavity to drain possible air leaks and fluid accumulations. Chest tubes after VATS     pulmonary wedge resections are left in place a minimum of 1 day. However, this practice has     no scientific foundations. The investigators believe it is possible to avoid the placement of     a chest tube after this procedure in a great amount of patients. This is a randomized     controlled clinical trial with analysis blinding in which the investigators want to compare     the outcomes between installing a chest tube or not after VATS pulmonary wedge resections.     The investigators will include consecutively patients with interstitial lung disease or     indeterminate pulmonary nodules undergoing this procedure, at the participating institutions.     The investigators calculated a sample size of 50 subjects in each group using pneumothorax <     10% data from Luckraz et al and to determine a difference of hospital stay of 2 versus 1 day;     DS(1.5), power = 0.9 and alpha = 0.05.   "
231258|NCT00879515|"     By testing physiological responses to anxiety in people with nervous system developmental     disorders, this study will identify specific physiological characteristics associated with     response to anxiety treatments.   "
228722|NCT00841802|"     This is a study to evaluate the cause of chronic sinus disease. Oral steroids have long been     used in the treatment of inflammatory conditions including chronic sinusitis, asthma, and     arthritis. However, it is not well known exactly which patients will benefit from steroids     when used in the treatment of chronic sinusitis. For some doctors, it is common practice to     use these medications prior to planned sinus surgery, to lessen the inflammation and possibly     help the healing process. Other doctors feel oral steroids may not be helpful in this way,     and there is no conclusive data as to whether this practice has a long term benefit.   "
228723|NCT00841815|"     The objective of this study is to compare the rate and extent of absorption of amlodipine     from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc®     10 mg Tablets under fed conditions.   "
228724|NCT00841828|"     Phase II randomized multicenter Trial to compare Epirubicine and Cyclophosphamide plus     Docetaxel and Trastuzumab with Epirubicine and Cyclophosphamide plus Docetaxel and Lapatinib     for patients with positive HER2 neu and resectable breast cancer or locally advanced breast     cancer.   "
228725|NCT00841841|"     Adequate postoperative pain management is challenging for practitioners despite recent     advances in pain control techniques and analgesic agents. The purpose of this study is to     compare the efficacy of Dipyrone and acetaminophen in postoperative pain after third molar     surgery.   "
228726|NCT00841854|"     At present, triple therapy are recommended by various guidelines for the treatment of     Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment     failure rates with one week first line clarithromycin based triple therapy necessitating     salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact     duration of bismuth based second line treatment is not determined. Therefore, the     investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple     regimen as a second-line therapy.   "
228727|NCT00841867|"     The purpose of this study is to examine changes in sugar metabolism that may occur in     subjects who have previously had part of their pancreas removed due to a benign lesion.   "
228728|NCT00841880|"     The objective of this study is to compare the reduction in office seated systolic blood     pressure (BP) following a 8 weeks regimen of ramipril 5mg plus felodipine 5mg versus ramipril     10mg.      To compare the response rate (defined as office systolic blood pressure (SBP) / Diastolic     blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined     as SBP<140mmHg and/or DBP<90mmHg) and as SBP < 130 mmHg and /or DBP < 80 mmHg in     diabetes,chronic kidney disease, known Coronary Arterial Disease (CAD) or CAD equivalent, or     10-year Framingham risk score > 10%.      To ascertain the safety and tolerability of ramipril/felodipine versus ramipril in Taiwanese     population.      To compare compliance with fixed dose combination of ramipril/felodipine versus ramipril     treatment.   "
228729|NCT00841893|"     The objective of this study is to examine whether a specific spice is capable of affecting     energy metabolism.      Since chili and other spices have been shown to increase energy expenditure and in some cases     also affect energy intake/appetite compared to placebo, the investigators expect that the     specific spice may actually increase energy expenditure and potentially also decrease     appetite - although not to a large degree.   "
228868|NCT00849888|"     The study purpose is to determine if thymus tissue cultured in a serum-free (SF) solution is     a safe and effective treatment for atypical and typical complete DiGeorge anomaly. [Funding     Source - FDA OOPD]   "
228730|NCT00841906|"     The objective of this study is to test the usability of the Alice PDx device by both the end     user (patient/participant) and the sleep technician. Data will be collected via     questionnaires regarding the participant's ability to understand the participant user manual     under home conditions and the technician's ability to set up the Alice PDx according to the     health care provider manual. This study will also compare the physiological data recorded by     the Alice PDx to the physiological data recorded by its predicate device the Alice 5 System     and validate its equivalence. This will be evaluated by comparing the manual study scores for     detected apnea and hypopnea events and on an event by event basis during a standard     polysomnography (PSG)/ sleep study. The study will test the ability of the Alice PDx to     record good quality data as determined by the Good Study Indicator (GSI) function of the     Alice PDx firmware.      The primary hypothesis is that the participant will be able to successfully apply the Alice     PDx basic leads following the participant user manual instructions and the sleep technician     will be able to successfully apply the advanced leads in preparation for the sleep study. In     addition, it will be demonstrated that the Alice PDx is equivalent to the Alice 5 System in     its intent to record, display and print physiological data to the clinician/physician in     order to aid in the screening/follow-up diagnosis of respiratory sleep disorders.   "
228731|NCT00841919|"     The purpose of this study is to determine if by using insulin analog (Glargine and lispro     insulin) with an insulin pen the investigators are able to obtain a higher rate of correct     timing of insulin and food administration as when compared to the usual therapy (insulin NPH     and regular) with syringes.   "
228732|NCT00841932|"     The purpose of this study is to assess the safety of performing fractional flow reserve (FFR)     of the myocardium without using anticoagulation by performing a retrospective review of 100     consecutive patients who have undergone this procedure during diagnostic catheterization.   "
228733|NCT00841945|"     Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy     after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and     localized B lymphoma , age 18 to 75 years.   "
228734|NCT00841958|"     The primary objective of this study is to test that endocardial stem cells implantation in     patients who have CAD, low ejection fraction and signs of HF without possibility of CABG and     PCI or despite on previous revascularization improves long-term survival compared to MED     alone   "
228735|NCT00841971|"     The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for     the prevention of fungal diseases in liver transplant recipients   "
228752|NCT00842205|"     In the presented project, the role of heme oxygenase 1 and 2 in the procesess associated with     fibroproduction in the chronic HCV infection will be studied. Heme oxygenase expression will     be evaluated by the techniques of molecular genetics and immunohistochemistry, both in the     liver tissue and in peripheral blood mononuclear cells. These parameters will be correlated     with basic virological and clinical characteristics of the chronic HCV infection. The     investigators' expected results may help in understanding the mechanisms of fibroproduction     in chronic HVC infection and, therefore, contribute to explain individual differences in the     development of chronic HCV infection.   "
228736|NCT00841984|"     The search for metabolic abnormalities in patients with neurological disorders represents an     important challenge 1) to identify new potentially treatable inherited metabolic diseases,     and 2) to identify biomarkers or new treatments in more common neurodegenerative or     neurogenetic disorders.      This approach is currently limited by the fact that techniques aiming at identifying abnormal     metabolites in human fluids (metabolomics) only detect subsets of molecules and that no     general assays is available to detect abnormalities in the metabolism of complex molecules     that takes place within cell organelles. As a consequence, only limited parts of the     metabolism can be studied simultaneously.      The aim of this study is to evaluate whether NRM spectroscopy of body fluids (urines,     cerebrospinal fluid) could allow to detect new metabolic abnormalities in patients with     complex neurological diseases.   "
228737|NCT00842010|"     This retrospective nested non-matched case control study compared patients directly admitted     to the General Medicine Wards, not transferred from ICU with        -  hyperglycemia on admission but no previous diagnosis of diabetes        -  diabetic hyperglycemic patients        -  non hyperglycemic non diabetic patients from the same nested population.      The investigators' hypothesis is that the clinical characteristics and endpoints of the non     diabetic hyperglycemics should be similar to the diabetic population and different from the     non diabetic non hyperglycemic population.   "
228738|NCT00842023|"     The purpose of this study is to determine whether Nesiritide is more effective than     nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity     when proper infusion duration is administered.   "
228739|NCT00842036|"     This research compares the benefits of the original treatment, Community Reinforcement and     Family Training (CRAFT), with the Treatment Entry Training (TEnT) component of CRAFT to     determine if TEnt alone can produce the primary outcome of CRAFT -- treatment entry of the     drug user. We also look at the impact on the well-being of the concerned significant other     and the drug use of their loved one.   "
228740|NCT00842049|"     Subarachnoid haemorrhage affects approximately 8000 people per year in the UK. The average     age of a patient with subarachnoid haemorrhage is 50 years, although it is often seen in     younger people (25-45 years). Despite modern medicine, the death and disability rate remains     high both from the initial bleed and from the associated complications such as vasospasm.     This is characterised by neurological impairment seen following the bleed. Despite modern     treatment this is still associated with a poor outcome. This has significant implications due     to the long term intensive neuro-rehabilitation these patients will require.      A recent study has shown that placing a small drain in the lower back following a     subarachnoid haemorrhage may reduce the chance of vasospasm occurring and result in a better     outcome. This trial was not optimally performed and so a trial is needed to look at this in     more detail. The investigators have set up such a trial in our neurosurgical unit. If the     investigators confirm that there is an improvement in patient outcome, it will change our     practice in the future.   "
228741|NCT00842062|"     A prospective, non-randomized study to evaluate the performance of the MyoScience Tissue     Remodeling Device for the treatment of glabellar lines (frown lines), lateral orbital lines     (crow's feet), and frontalis lines (horizontal forehead lines).   "
228742|NCT00842075|"     The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin     immediately prior to meals can significantly reduce post-prandial glucose concentrations     compared with mealtime insulin alone in children with type 1 diabetes.      This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking     pramlintide before all meals) and a control arm (diabetes regimen as usual).   "
228743|NCT00842088|"     The purpose of this study is to assess the safety and tolerability of HQK-1001 administered     for a total of 12 weeks (with one dosing break) in subjects with sickle cell disease.   "
228744|NCT00842101|"     The purpose of this study is to determine the effect of reamed intramedullary nails in tibial     shaft fractures (as a standard treatment), in raising intracompartmental pressures and     therefore determine if they are a risk factor for compartmental syndrome.   "
228745|NCT00842114|"     Rituximab plus CVP and Interferon chemoimmunotherapy for newly diagnosed Follicular Lymphoma     with FLIPI index >2   "
228746|NCT00842127|"     The purpose of this study is to examine whether genetic polymorphisms in drug transporters     were associated with the side effects of OROS-methylphenidate medication in attention     deficit/hyperactivity disorder(ADHD).   "
228747|NCT00842140|"     The purpose of this study to assess early markers of cardiovascular disease in women with     polycystic ovary syndrome in use of oral contraceptive containing ethynilestradiol and     chlormadinone acetate alone or associated with Spironolactone.   "
228748|NCT00842153|"     The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to     that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.   "
228749|NCT00842166|"     The aim is to document viral etiologies of isolated fevers and inlfuenza-like syndromes     during summertime in South of France in order to better understand the role of known     vector-borne viruses such as Toscana virus, West Nile virus during seasonal activity of the     arthropod vector. In each of the four cities, a network of general practitioners will be     associated in the project to recruit patients who are not hospitalized. The combined     involvement of infectious disease specialists and general practitioner will augment the range     of patients (mild disease and sever cases) in the study.   "
228750|NCT00842179|"     The objective of this study is to compare groin complication rates in low and high risk     patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose     vascular closure device (VCD) or manual compression.   "
228751|NCT00842192|"     This study is conducted in Asia. The aim of this observational study is to investigate the     safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are     using oral antidiabetic drugs.   "
228753|NCT00842218|"     The purposes of this study were as follows: 1) to compare locomotion parameters (kinematic,     EMG, mechanical work and energy cost changes during walking in able-bodied subjects and AIS     patients,2) to evaluate the effects of the frontal curve's severity of the AIS and 3) the     effects of the treatment (orthosis or surgery)on these gait parameters.   "
228754|NCT00842231|"     To assess visual performance in patients with low levels (0.5-0.75 Diopters) of corneal     astigmatism.   "
228756|NCT00842257|"     The purpose of this research study is to learn whether panitumumab helps treat colorectal     cancer in participants who have not responded to treatment with cetuximab. Panitumumab is a     human monoclonal antibody. Antibodies are proteins that recognize a foreign substance in the     body and then attach themselves to it making it exposed to destruction. Panitumumab attaches     itself to a protein on cancer cells called epidermal growth factor receptor or EGFR. EGFR     helps cancer cells to grow, and blocking EGFR helps prevent cancer cells from growing.   "
228757|NCT00842270|"     The aim of the study is to evaluate, comparatively to a placebo, the activity of oral AB1010,     administered at three dose levels during 4 months to patients with severe persistent     corticosteroid dependent asthma, assessed on :        -  the decrease in corticosteroid therapy        -  the asthma control improvement (symptomatic scores, rescue medication intake,          respiratory function)        -  the pharmacokinetic profile of AB1010        -  clinical and biological safety parameters   "
228758|NCT00842283|"     The researchers believe that pro-angiogenic factors are upregulated in a wide range of     dermatologic diseases including port wine stains, hemangiomas, angiofibromas, Kaposi's     sarcoma, angiosarcoma, scars, rosacea and psoriasis.      The researcher can perform immunohistochemistry and/or microarray analysis and/or     quantitative polymerase chain reaction on previously biopsied skin specimens and newly     biopsied skin specimens to evaluate the expression of various angiogenic factors in these     dermatologic diseases.      In addition, some of the skin specimens may be utilized to make cell cultures to study     expression of angiogenic factors and interactions of cells in dermatologic disease.   "
228759|NCT00842296|"     The purpose of this study is to confirm that the ClosureFAST system can be used as an     alternative to the current ClosurePlus catheter for treating the GSV and to accumulate     pivotal data for optimization of the operating parameters.   "
228760|NCT00842309|"     The purpose of the study is to conduct a double-blind, placebo-controlled study of     D-cycloserine (DCS) augmentation of behavior therapy in individuals with Body Dysmorphic     Disorder (BDD). Specifically, we intend to randomize 50 individuals with BDD to receive     either DCS (n = 25) or placebo (n = 25) one hour prior to 8 of 10 behavior therapy sessions.   "
228761|NCT00842322|"     Patients with renal impairment are usually advised to increase their fluid intake. There is     currently, however, no evidence supporting this recommendation. In contrast,high fluid intake     could be dangerous if urine excretion is reduced. In this study the researchers investigate     whether increasing fluid intake from 2 to 4 litres per day has any influence on long-term     renal outcome.   "
228762|NCT00842335|"     The purpose of this study, the first clinical trial of JI-101, is to determine the maximum     tolerated dose of JI-101 when given orally to patients with solid tumors. Safety,     tolerability, pharmacokinetics, pharmacodynamics, and the effects of the drug on tumor     metabolism will also be studied. JI-101 is an inhibitor of new blood vessel growth that may     provide benefit to patients with solid tumors that have failed standard therapeutic regimens.   "
228763|NCT00842348|"     The primary purpose of this extension study was to assess the long term safety of patients     with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open     label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study,     2-55-52030-726 (NCT00353496).   "
228764|NCT00842361|"     This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety     (with emphasis on hypoglycaemia) after switching from long-acting insulin     analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a     twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily     regimen in subjects with type 2 diabetes mellitus.   "
228765|NCT00842374|"     This is a registry of patients with non ST segment elevation Myocardial Infarction (heart     attack) and/or unstable acute coronary artery syndrome treated with a standardized protocol     including Bivalirudin.      Data will be collected on diagnosis, treatment and outcomes.   "
228766|NCT00842387|"     The aim of this project is to compare the GERD clinical outcomes in patients where a     structured pathway using the GerdQ questionnaire is implemented compared with the clinical     outcomes of those treated without this implementation.      This is a European project with 5 participating countries (Austria, Italy, Norway, Spain and     Sweden). Due to different characteristics regarding the actual management of this disease in     the 5 countries, each country had the flexibility to introduce design differences and changes     in the study protocol.   "
228767|NCT00842400|"     The purposes of this study are to:        -  Find out how much of the study drugs are in the blood of healthy subjects after taking          multiple doses of VI-0521, metformin and sitagliptan.        -  Determine the effect of probenecid on the amount of VI-0521 in the blood of healthy          subjects after taking multiple doses.        -  Find out how much topiramate is in the semen of healthy male subjects after taking          multiple doses.   "
228768|NCT00842413|"     This project aims at understanding better the role of the frontal lobe of the brain in our     capacity to perceive visual information consciously, and also, in our capacity to perceive     others' actions. It includes a test where we ask subjects to detect visual information in     front of a computer screen, and another test where we ask them to imitate finger movements.   "
228769|NCT00842426|"     The purpose of the E-LITE Study is to evaluate the feasibility and potential effectiveness of     two lifestyle interventions in a community based primary care setting. The study aims to     assess how changes in diet, exercise, and behavioral self-management affect weight and     related risk factors for adults at risk for diabetes and cardiovascular disease.   "
228783|NCT00842608|"     The purpose of this study is to develop and test the feasibility of using a specific     pharmacological protocol to reduce delirium burden among older adults in the Intensive Care     Unit (ICU). The study will test the efficacy of a pharmacological intervention in reducing     delirium severity and duration as well as length of stay and mortality compared to usual     care.   "
228813|NCT00848471|"     Measurement of energy expenditure at rest (12 hours fasting) and in dynamic phase after a     meal (600kcal) to compare the results of the two calorimeters in standardized conditions for     the validation of quark RMR versus Deltatrac II   "
228814|NCT00848484|"     This study is to evaluate the safety and efficacy of the study drug compared to placebo in     the treatment of cognitive impairment in men with schizophrenia.   "
228770|NCT00842439|"     Understanding the joint neurobiological and social bases to aggression is critical to future     attempts to tackle this major public health problem. The overarching goals are: (a) to     conduct perhaps the most systematic integration of biosocial risk factors for childhood     aggression in order to predict later aggression, (b) to conduct one of the very few biosocial     interventions on childhood aggression, (c) to predict and treat two fundamentally different     manifestations of aggression proactive and reactive aggression which likely have different     etiologies and responsiveness to treatment. The specific aims are: (1) to assess biological     (genetic, neurocognitive, brain imaging, neuroendocrinological, neurotoxin,     psychophysiological, nutritional), psychosocial (neighborhood, family, school, peer,     psychological) and psychiatric (ADHD, CD, ODD, depression, anxiety, PTSD,     schizophrenia-spectrum) risk factors for male and female aggression in order to better     predict later aggression, (2) to improve prediction by identifying the genetic, neuroimaging,     psychophysiological, and neuroendocrinological factors that protect children who are socially     at risk for a violence outcome, (3) to develop a genetic mouse model of aggression to test     the effectiveness of nutritional interventions in reducing aggression, (4) to begin to     develop a new biosocial approach to the treatment and prevention of aggression, based on both     cognitive-behavioral and nutrition interventions, (5) to assess the differential prediction     and treatment of two fundamental variants of child aggression: proactive and reactive     aggression. The human sample will consist of 500 male and female 11-year-old children drawn     from high-risk communities in Philadelphia. Three hundred participants will engage in a     baseline assessment for risk factors for aggression, and then be randomly assigned to one of     four three-month intervention programs: treatment-as-usual, cognitive-behavioral     intervention, nutrition supplementation, or CBI + nutrition. Aggression outcome will be     assessed throughout intervention and post-intervention.      The investigators believe that biological risk factors will interact with social risk factors     in predicting aggression, over and above main effects of these classes of risk factors.     Treatment effectiveness will interact with risk factors: those with low omega-3 and high lead     exposure at intake will benefit most from the nutritional intervention; those with cognitive     and affective risk factors will benefit most from the neuro-cognitive-behavioral     intervention.   "
228771|NCT00842452|"     RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in     treating patients with gynecologic cancer that cannot be removed by surgery.   "
228772|NCT00842465|"     Prolactin is known to play an important role in breast development and differentiation. Thus     proliferative breast diseases are good models to unravel PRl / PRLR function in proliferative     processes.      The aim of this project is to identify and to characterize new mutants of the prolactin     receptor gene within cohorts of benign or malign breast diseases with low or high occurrence     frequency in human populations   "
228773|NCT00842478|"     Poor oral hygiene is associated with respiratory pathogen colonization and secondary lung     infection.The possible association between oral care and incidence of VAP, and the role of     dental plaque, mouth and tracheal colonization have not been firmly established. The     investigators' hypothesis was that improving oral care with electrical toothbrushing might be     effective in reducing the incidence of VAP.   "
228774|NCT00842491|"     The purpose of this study is to investigate whether endostar (recombinant human     endostatin)with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced     gastric cancer is effective and safe.   "
228775|NCT00842504|"     The purpose of this study is to examine the pharmacokinetics of micafungin when it is given     on an every other day schedule. The study will determine if every other day micafungin will     provide drug exposure equivalent to daily dosing while reducing administration costs and     improving patient convenience. Fifteen patients will be enrolled on this study. Blood samples     for PK measurements will be obtained for 48 hours following a single dose of micafungin (3     mg/kg).   "
228869|NCT00849901|"     The purpose of this study is to assess whether duloxetine is superior to placebo in the     treatment of children and adolescents with major depressive disorder (MDD)   "
228776|NCT00842517|"     The purpose of this study is to develop a model for long-term maintenance of behavior change     by examining the effects of extending the duration of contingency management (CM) for drug     abuse on long-term abstinence outcomes. The primary hypothesis is that the Extended (36 week)     CM group will have better long-term outcomes as exhibited by greater rates of abstinence at     each follow-up assessment as compared to the Standard (12 week) CM group.   "
228777|NCT00842530|"     There is currently no vaccine against dengue and no specific drug treatment against the     disease. This study is aimed at generating information on the protective effect of the     vaccine.      Primary Objective To assess the efficacy of dengue vaccine after three injections in     children.      Secondary Objective:      To evaluate the reactogenicity of dengue vaccine after each injection in a subgroup of     children.   "
228778|NCT00842543|"     Our study aims to evaluate if the consumption of a Fruit and Vegetable Juice Concentrate     (FVJC) vs. placebo can exert changes in the serum levels of Retinol Binding Protein 4 (RBP4),     carotenoids, tocopherol, antioxidant capacity, pro-inflammatory markers, insulin sensitivity     in conjunction with weight management in a cohort of lean as compared to overweight healthy     six to ten year-old boys. The boys will undergo a detailed medical and family history and a     complete physical examination during the screening visit. Careful anthropometric measures and     body composition by DEXA will be performed. Nutritional and exercise counseling will be given     at the start of the study. The outcome measures will include differences in serum RBP4,     antioxidant levels, inflammatory markers and insulin sensitivity at baseline and six months     after consumption of FVJC in a randomized double blind placebo control manner.   "
228779|NCT00842556|"     To assess the effect of glimepiride on the PK of dapagliflozin and the effect of     dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A)     and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of     dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)   "
228780|NCT00842569|"     There is growing evidence of behavioural and neurobiological overlaps between obesity and     drug abuse. Reduction of the amplitude of P300, a component of event-related potentials (ERP)     elicited by an oddball paradigm, is an electrophysiological characteristic and a marker of     vulnerability in substance abuse. We want to determine whether obesity is associated with     such electrophysiological features during an auditory oddball paradigm. We postulate that     obesity could be associated with electrophysiological abnormalities that could be viewed as a     possible vulnerability marker for food addiction.   "
228781|NCT00842582|"     This is a clinical trial for women with newly diagnosed ovarian cancer. The purpose of this     study is to determine if the addition of a drug called azacitidine (Vidaza®)when added to     carboplatin and paclitaxel will change the genetic material of the tumor so that the     chemotherapy drugs work better.      The study will also determine what the maximum tolerated dose of azacitidine that may be     safely used in combination with carboplatin and paclitaxel.   "
228782|NCT00842595|"     The primary objective of the protocol is to estimate the complete response rate of three     courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone     in relapsed aggressive non hodgkin's B-cell lymphoma   "
228794|NCT00842764|"     The purpose of this research study is to is to evaluate the safety and effectiveness of the     FDA approved Holmium:YAG laser for reducing lower eyelid bags.   "
228784|NCT00842621|"     In this prospective observational trial, participants with chronic hemolysis will be assessed     with echocardiogram for elevated tricuspid jet velocity and other evidence of pulmonary     hypertension. Participants will have laboratory studies evaluating: severity of hemolysis,     splenic function, inflammation, endothelial dysfunction, and hypercoagulability. There will     be 3 main categories of participants enrolled in this study: (1) pediatric participants with     severe sickle cell disease (SCD) (HbSS, HbS/β° thalassemia ) who are not receiving treatment     (e.g., hydroxyurea or chronic transfusions); (2) pediatric participants with other forms of     SCD or severe SCD (HbSS, HbS/β° thalassemia) patients being treated with hydroxyurea or     chronic transfusions; and (3) pediatric and adult participants with other non-sickling     hematological disorders.   "
228785|NCT00842634|"     This research study is being carried out to study a new way to possibly treat HIV. This agent     is called a Zinc Finger Nuclease or ZFN for short. ZFNs are proteins that can delete     another protein named CCR5. This CCR5 protein is required for certain common types of HIV     (CCR5 tropic) to enter into and infect T-cells. T-cells are one of the white blood cells used     by the body to fight HIV. The most important T-cells are those called CD4 T-cells.      Some people are born without CCR5 on their T-cells. These people remain healthy and are     resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and     their HIV disease is less severe and is slower to cause disease (AIDS).      In order to delete the CCR5 protein on the T cells, this study will isolate large numbers of     T-cells from subjects, and then deliver the ZFNs using a delivery vehicle called a viral     vector. The viral vector used in this study is called an adenoviral vector. The vector is     added to the cells at the beginning of the manufacture process and the ZFNs knock out the     CCR5 protein. By the time T-cells are returned to subjects, there is minimal adenovirus or     ZFN present. The removal of the CCR5 protein on the T-cells subjects receive, however, is     permanent.      The purpose of this research study is to find out whether zinc finger modified T-cells are        1. safe to give to humans and        2. find how zinc finger modified T cell affects HIV      This is an experimental study. Laboratory studies have shown that when CD4 T-cells are     modified with zinc fingers, HIV is prevented from killing the CD4 T cells. On the basis of     these laboratory results, there is the potential that zinc fingers may work in humans     infected with HIV and improve their immune system by allowing their CD4 T-cells to survive     longer (HIV usually kills T cells it infects).      All subjects who receive ZFN Modified CD4+T cells will enroll in a Long Term, Follow-up study     to monitor subjects. Subjects will be followed every 3 months for four years. If the ZFN     Modified CD4+T cells are no longer found in the blood after four years, then subjects will be     contacted yearly for the next 6 years. If the ZFN Modified CD4+T cells are found in the blood     at year four, then the subjects will continue to be seen once a year until the ZFN Modified     CD4+T cells are no longer found in the blood for a maximum of 10 years.   "
228786|NCT00842647|"     This study prospectively evaluates the accuracy of the noninvasive diagnostic criteria for     hepatocellular carcinoma.   "
228798|NCT00842816|"     This study will investigate the ability of ST101 to improve memory in people with Alzheimer's     disease who currently receive 10 mg Aricept® (donepezil) per day. This study also will     examine the safety and tolerability of the drug. This study is evaluating 3 different dose     levels of ST101 and placebo. Patients will have a 1 in 4 chance of getting placebo. All     eligible subjects will be provided with bottles of 10 mg Aricept (donepezil) during the study     drug administration part of the study.   "
228820|NCT00848562|"     Survival after invasive coronary revascularization is worse in patients with chronic kidney     disease than in those without it. The investigators aimed to examine whether oral     administration of nicorandil, a hybrid of nitrate and adenosine triphosphate-sensitive     potassium channel opener, could improve the survival of end-stage renal disease patients with     coronary artery disease by inhibiting cardiac death after coronary revascularization.   "
228787|NCT00842660|"     Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment     for patients with cervical cancer. However, in patients with advanced cervical cancer, half     of them treated with contemporary radiotherapy plus single agent cisplatin still suffered     from the local or distant relapse. How to improve the treatment outcome of these patients is     a very important issue and requires further clinical investigation.      The major aim of this project is to conduct a prospective, randomized phase III clinical     trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and     gemcitabine have better survival rates than those treated by radiotherapy with cisplatin     alone.      Gemcitabine has been demonstrated to be a good radiosensitizer. In keeping with this, few     clinical trials in early phases showed promising results when using concurrent radiotherapy     with cisplatin and gemcitabine. According to these positive results, the investigators expect     this trial has the potential to improve the survival in patients with advanced cervical     cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.   "
228788|NCT00842673|"     This study will investigate the ability of ST101 to improve memory in people with Alzheimer's     disease. This study also will examine the safety and tolerability of the drug. This study is     evaluating 3 different dose levels of ST101 and placebo. Patients will have a 1 in 4 chance     of getting placebo.   "
228789|NCT00842686|"     The use of preoperative chemoradiation and adjuvant chemotherapy with 5-FU based chemotherapy     reduced local recurrence rate to less than 10%, but has only had limited effect on overall     survival due to the constantly high (more than 30%) rate of distant metastasis.      However, it has been shown that complete eradication of the primary tumour observed in the     histopathological specimen (pathological complete response, pCR) correlates with a favourable     overall prognosis so obtaining a pCR might be beneficial. The aim of the study is to     investigate whether the addition of bevacizumab to preoperative fluoropyrimidinebased     chemoradiation improves pathological complete remission rate in locally advanced rectal     cancer with acceptable toxicity. Secondary objectives are to evaluate pathological     downstaging rate, histopathological R0 resection rate,sphincter preservation rate,     perioperative surgical complication rate, local control, DFS, OS, late toxicity and quality     of life.   "
228790|NCT00842699|"     The goal of the study is to find out the effects of two different drugs used at the beginning     of organ transplantation on different populations of immune cells in the body of patients.   "
228791|NCT00842712|"     Primary objective of the study's Safety run-in:      - To determine the maximum tolerated dose (MTD) of cilengitide in combination with cetuximab,     and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).      Primary objective of the study's Randomization Part:      - To assess the efficacy of cilengitide in combination with cetuximab and platinum-based     chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine) compared to cetuximab and     platinum-based chemotherapy alone in terms of progression-free survival (PFS) time.      Study design and plan:      This is a multicenter, open-label, randomized, controlled Phase II study with a safety run-in     part in subjects with advanced non-small cell lung cancer (NSCLC).      During the safety run-in, the regimen was intensified stepwise by cohort (cilengitide     intravenous [i.v.] 1000 milligram [mg] to 2000 mg twice a week) in a classical 3+3 subjects     (for each platinum-based chemotherapy regimens separately) approach with predefined dose- and     schedule reduction rules.      In the safety run-in 12 subjects were included and evaluated for safety and feasibility of     different escalating doses of cilengitide administered twice weekly in combination with     cetuximab, cisplatin and vinorelbine or gemcitabine.      After completion of the safety run-in, the randomized part will be started, during which all     subjects will receive cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or     cisplatin/gemcitabine).      Subjects will be centrally randomized on a 1:1 basis to either Group A or C; Group B will be     closed with implementation of Amendment No. 4 (dated 20 December 2010):      • Group A: Cilengitide 2000 mg once weekly (Days 1, 8, and 15 of every 3-week chemotherapy     cycle) in combination with cetuximab and platinum-based chemotherapy that will consist of the     following:        -  Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and vinorelbine on          Days 1 and 8 of every 3-week chemotherapy cycle, or        -  Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and gemcitabine on          Days 1 and 8 of every 3-week chemotherapy cycle.      The decision which of the 2 chemotherapy regimens will be applied for a given subject is at     the discretion of the treating investigator.      • Group B: Cilengitide 2000 mg twice weekly (Days 1, 4, 8, 11, 15, and 18 of every 3-week     chemotherapy cycle) in combination with cetuximab and platinum-based chemotherapy as     described for Group A.      Group B will be closed with implementation of Amendment No. 4 (global, dated 20 December     2010). Subjects randomized to Group B before implementation of Amendment No 4 will continue     to be treated as planned.      • Group C: Cetuximab and platinum-based chemotherapy as described for Group A      Chemotherapy will be given until radiographically documented progressive disease (PD) or     unacceptable toxicity but for no more than 6 cycles.      Cilengitide and cetuximab will be given until radiographically documented PD or unacceptable     toxicity.      Randomization will be performed centrally using an interactive voice/web response system     (IXRS). A stratified block randomization procedure will be employed using chosen first-line     chemotherapy (cisplatin/vinorelbine versus cisplatin/gemcitabine) as stratification     criterion.   "
228792|NCT00842738|"     In this study two questions will be answered:        -  can mindfulness meditation help cell-changed on the cervix to disappear?        -  can mindfulness meditation lower the psychological distress when women have abnormal          cervical cancer screening results?   "
228793|NCT00842751|"     The purpose of this study is to test how the body absorbs and processes new forms of oral     testosterone. Information gained during the study may help develop better forms of     testosterone therapy in the future.   "
228795|NCT00842777|"     Long term effects of treatment of childhood obesity are not well documented but there is     growing evidence that parental involvement and behavioral changes are strong predictors of     children weight loss. However, which form and content of parental involvement are most     effective is not studied. In the present randomized controlled study we compare the effect of     parent manualized group treatment (experimental group) to the effect of parent self-help     groups on changes in children Body Mass Index, food intake, physical activity, quality of     life and self esteem. We pose the following hypotheses:        1. Parents participating in the experimental group will have children who achieve a larger          reduction in BMI than children with their parents in the control group.        2. This treatment effect will be mediated by changes in one of several elements of parents'          cognition: outcome expectancies, perceived control, perceived value of outcome,          self-efficacy, perceived reduction in barriers, and subjective norms.        3. Reduction in BMI will correlate with increased quality of life, reduced number and          severity of mental health problems, and increased self-concept.   "
228796|NCT00842790|"     The goal is to study the impact of functional MRI and CT evaluation of changes in tumor     vessels induced by anti-angiogenic treatment in patients with metastatic RCC.      The hypothesis is that good responders and poor responders will have different responses     induced by anti-angiogenic treatment, and that the detection of theses changes by functional     imaging can improve the therapeutic management.      Functional CT and MRI will be performed in 200 patients before the beginning of     antiangiogenic treatment, 7 days after and every 6 week until tumor progression (as defined     by the RECIST criteria). Perfusion and diffusion parameters will be measured using a     dedicated software.   "
228797|NCT00842803|"     The purpose of the study is to examine if outcome after liver transplantation is improved by     using albumin infusion post-transplantation.   "
228821|NCT00848575|"     The culdoscopic approach will allow for equal or better visualization of female pelvic     structures   "
246508|NCT01090544|"     The purpose of this study is to determine wether transnasal insufflation as an alternate form     of breathing support for COPD patients will lead to improvement of their medical condition.   "
228799|NCT00842829|"     Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal     Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving     maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually     titrated to an effective dose that provides adequate analgesia and minimizes undesirable     effects. To reach the safest effective dose for the individual patient as soon as possible,     the dose titration process is critical. The aim of this study, conducted under pragmatic     conditions in a large-scale population of cancer patients is to compare the proportion of     patients reaching an effective FBT dose after titration starting with either a 100 mcg dose     or a 200 mcg dose.   "
228800|NCT00842842|"     The purpose of this study is to determine whether mesh fixation in laparoscopic umbilical     hernia repair with fibrin glue is superior to tacks in terms of postoperative pain and     recovery.   "
228801|NCT00842855|"     The purpose of this study is to describe common treatment pathways, to collect health care     utilization data and to assess symptom load as well as impact of symptoms on daily life in     GERD patients who are partial-responders to PPI treatment.   "
228802|NCT00842868|"     The purpose of this research is to determine the relationship between novel blood tests for     heart function (including hormones and heart enzymes measured in the blood), and assess for     kidney damage before and after angiography (cardiac catheterization). We hypothesize that     these novel tests will enable us to predict possible complications of catheterization     immediately after the procedure.   "
228803|NCT00842881|"     The purpose of this study is to determine whether Healing stone navel belt is safe and     effective in the treatment of Primary Dysmenorrhea.   "
228804|NCT00842894|"     This study is conducted in Europe. The aim of this observational study is to investigate the     incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart     30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal     clinical practice conditions in Macedonia.   "
228805|NCT00842907|"     This is a randomized, comparative, single evaluator-blinded trial to evaluate clinical,     histological and immunohistochemical effects of oral isotretinoin plus moisturizer sunscreen     as compared to the use of 0,05% tretinoin cream plus moisturizer sunscreen for the treatment     of photodamage on face and forearms. Main oral isotretinoin safety parameters will also be     analyzed, as well as adverse events related to topical products.   "
228806|NCT00842920|"     Probands with MCI are at high risk to develop Alzheimer´s dementia (AD). Simvastatin may     lower the production of Amyloid, a hallmark of AD in the brain. The primary hypothesis of the     study is that 60 mg Simvastatin significantly reduces the Clinical Dementia Rating -Sum of     boxes (CDR-SOB) in individuals with MCI as compared to MCI receiving placebo or 20 mg     Simvastatin   "
228807|NCT00842933|"     Randomized controlled trial evaluating the duration of steroid replacement therapy in     patients with adrenal insufficiency and septic shock. Patients will be randomized to receive     either hydrocortisone 50 mg IV every six hours for seven days (control) or hydrocortisone 50     mg IV every six hours until 24 hours after achievement of hemodynamic stability (MAP > 65 mm     Hg off of vasopressors).   "
228808|NCT00842946|"     The purpose of this study is to compare two exposure-based behavioral group treatments for     public speaking anxiety. Specifically, exposure within the context of psychological     acceptance will be compared to exposure within a standard habituation context. It is     hypothesized that participants receiving exposure within the context of psychological     acceptance will experience a greater decrease in anxiety and greater improvement in quality     of life compared to the habituation-based group.   "
228809|NCT00842959|"     It is planned to implant the intraocular lenses XL Stabi ZO and Invent ZO into the eyes of     patients for whom a cataract operation is medically indicated. The lenses are marketed and CE     certified. Their implantation is clinical routine.      In the trial the accuracy of prediction of target refraction and the difference between     calculated and measured contrast vision will be examined for both lens types.   "
228810|NCT00842972|"     This study was conducted to evaluate the effect of A1C variability on the progression of     carotid artery intima-media thickness in type 2 diabetic patients.   "
228815|NCT00848497|"     The purpose of this study is to determine the effectiveness of testosterone replacement     therapy (TRT) in men following surgery to remove the prostate in improving erectile function.     Subjects will be randomized (like flipping a coin) to one of two groups. One group will     receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and the other     will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night.      Subjects will begin drug treatment 3 months after the initial screening visit and will take     study drug for 3 months only. Participation will end at the end of the 6-month visit.   "
228816|NCT00848510|"     This study is intended to test an experimental drug called EMD 525797 (Abituzumab). This drug     is not yet approved for sale and has only been tested in a small number of people to date     (prior to this study starting another research study was carried out involving 37 healthy     volunteers receiving the study drug). Until more is known about this study drug, it can only     be used in research studies.      This research study is planned to answer important questions about how the study drug is     tolerated and how it may work in subjects with ovarian and colorectal cancer which has spread     to the liver (i.e. metastatic cancer). The Sponsor (Merck KGaA) of this study is developing     the study drug.   "
228817|NCT00848523|"     The drug LBH589 (panobinostat) is an experimental (investigational) drug that is being tested     for recurrent (returning) malignant gliomas. An investigational drug is one that has not been     approved by the U.S. Food and Drug Administration (FDA). It belongs to a new class of drugs     called histone deacetylase inhibitors. Histones are proteins located in the nucleus of     cells that bind to DNA, the chemical that makes up genes. These proteins help control which     genes are turned on and off. Studies have shown that drugs like panobinostat (LBH589) may     lead to tumor cell death.   "
228818|NCT00848536|"     A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to     TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension   "
228819|NCT00848549|"     The purpose of this study is to assess the long-term safety and tolerability and to explore     the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly     diagnosed partial seizures.   "
228822|NCT00848588|"     The overall goal of this pilot study is to design and conduct a survey of 9-1-1 call takers     in the province of Ontario, Canada to better understand the factors associated with the     successful identification of cardiac arrest (including victims with agonal breathing) over     the phone. Specific objectives are:        1. To conduct iterative semi-structured interviews to identify behavioural factors          influencing identification of cardiac arrest by 9-1-1 call takers;        2. To develop a survey instrument about behavioural factors influencing the ability of          9-1-1 call takers to identify cardiac arrest based on a systematic review of the          literature, the results of the semi-structured interviews, and theoretical constructs          from the Theory of Planned Behaviour; and        3. To conduct a survey among Ontario 9-1-1 call takers using the survey instrument, and to          identify factors and strategies that might be targeted by Knowledge Translation          interventions.   "
228823|NCT00848601|"     Patients with hormone and docetaxel refractory prostate cancer or relapsed/refractory     non-Hodgkin's lymphoma for which no available standard therapy or therapy which may provide     clinical benefit is available will be enrolled. Primary objectives: estimate the maximum     tolerated dose and dose-limiting toxicities. Secondary objectives: Response rate,     pharmacokinetic and pharmacodynamic profiles, Prostate Specific Antigen response and renal     elimination.   "
228824|NCT00848627|"     In the study proposed, up to 1,500 men age 60 and over with strong smoking histories will     test their urine for the presence of blood daily for two 10-day testing periods with the Ames     Hemastix. Individuals with even a solitary positive test will undergo a thorough urologic     evaluation to determine the cause of hematuria and follow-up will continue for 2 years after     completion of the study.   "
228825|NCT00848640|"     The purpose study is to evaluate the efficacy and safety of Sorafenib as first line treatment     for patients - unsuitable for another approved first line therapy - with advanced RCC in the     Middle East Region.   "
228826|NCT00848653|"     The ELECtrode configuraTION CRT Study (ELECTION)   "
228827|NCT00848666|"     The purpose of this study is to evaluate the safety and efficacy of a novel topical therapy     in patients with laboratory confirmed tinea pedis. During the follow-up period clinical and     mycological examinations will be performed.   "
228828|NCT00848679|"     The investigators previously demonstrated that epidural ropivacaine reduces uterine artery     vascular resistance in a dose dependent manner in pre-eclampsia. The investigators also noted     a marked right-left difference in vascular resistance between paired uterine arteries, which     was almost completely abolished following epidural ropivacaine. However, this novel     observation was not a stated outcome variable before the study began. This study assesses     right-left difference in vascular resistance between paired uterine arteries as a primary     end-point, assesses the dose-response effect of epidural lidocaine and compares the effect     observed in pre-eclampsia with that in two control populations (term normal pregnancy and     non-pregnant controls).   "
228829|NCT00848692|"     Based on pilot patient observations,the investigators anticipate that chronic fatigue     syndrome (CFS) patients may benefit from B-cell depletion therapy.      The hypothesis is that at least a subset of CFS patients have an activated immune system     involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.   "
228830|NCT00848705|"     The goals of this R21 exploratory pilot and feasibility study were to: 1) design an     Internet-based self-management intervention for adolescents with type 1 diabetes; 2) test     that intervention in a small randomized trial to establish technical feasibility,     intervention acceptability, and competence in completing the necessary recruitment and     research procedures. Although not powered to detect statistically significant changes,     possible outcomes of this study include improvements in problem-solving, coping, and     self-management behaviors.   "
228831|NCT00848718|"     The purpose of this study is to compare the safety and tolerability of several dose levels of     MK-2206 in combination with chemotherapy and targeted therapy agents in participants with     locally advanced or metastatic solid tumors.   "
228832|NCT00848731|"     This study will test the hypothesis that patients with acute PE and dyspnea can safely inhale     NO. The secondary hypothesis is that patients who are blinded to the inhaled NO concentration     will sustain subjective improvement in their perception of dyspnea based upon their reported     Borg dyspnea score, during inhalation of NO.      Specific aims        1. Test if patients with acute PE and shortness of breath of severity ≥ 5 on a 0-10 scale          called the Borg score can have inhaled nitric oxide administered via nasal cannula or          face mask in a titration protocol that increases concentration by 5 ppm in 5 min steps          to a maximum of 25 ppm.        2. We will measure the number of patients who meet an absolute safety endpoint during          titration. An absolute safety endpoint requires execution of a rapid weaning protocol (2          ppm decrease per minute to 0 ppm).           Absolute safety endpoints: Two consecutive SBP measurements more than one min apart with          both readings < 80 mm Hg;SaO 2 <80% for more than 15 seconds; Patient deterioration as          defined by: Clinical decision for need of inotropic or pressor support for any reason,          seizure, new altered mental status, focal neurological signs suggestive of cerebral          ischemia, evidence of myocardial ischemia, protracted vomiting.        3. Test if the patient-reported Borg score decreases with administration of NO. Patients          will not be told any details about the timing of the titration and will not be made          aware of their iNO concentration when the Borg score is assessed.   "
228833|NCT00848744|"     This study is a split face, paired-comparison, pilot study of at least 10 subjects to     complete. Participants in this study will be patients seen at Children's Memorial Hospital,     who are clinically diagnosed with mild to moderate acne vulgaris. Participants will be     recruited from one of the clinics, as well as from previous IRB approved acne studies housed     in the Department of Dermatology. All subjects accrued from previous studies have agreed to     be contacted for further investigations. Subjects 13 to 35 years of age with mild to moderate     acne vulgaris symmetrical in appearance on both sides of the face, and meeting inclusion     criteria will be eligible to participate   "
228834|NCT00848757|"     The purpose of this research collaboration between Dr. William Tamborlane, Deputy Directory     of the Yale Center for Clinical Investigation (YCCI) and Fair Haven Community Health Center's     (FHCHC) Diabetes Prevention Team is to determine the efficacy of an intensive life-style     intervention (ILI) program that has been developed and implemented at the FHCHC to prevent     the development of diabetes.   "
228835|NCT00848770|"     This is a controlled clinical trial among non thrombolysed acute ischemic stroke patients to     determine the effects of three levels of arterial pressure on death and neurological     disability. After the admission in the vascular unit of the Emergency Department the patients     are randomized to maintain during the first 24h the Systolic Arterial Pressure in tree levels     of pressure: 140 to 160 mmHg; 161 to 180 mmHg and 181 to 200 mmHg. The end point of the study     is the Modified Rankin score and mortality in three month after the discharge.   "
228836|NCT00848783|"     This study is to determine whether intraperitoneal (IP) Floxuridine is effective in the     patients with advanced stomach or gastro-esophageal junction cancers in the treatment     consisting of pre- and post-surgery chemotherapies.   "
228837|NCT00849459|"     RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body     build an immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in     treating women with metastatic breast cancer.   "
228838|NCT00849472|"     The purpose of this study is to determine whether the treatment of a doxorubicin in     combination with cyclophosphamide followed by a combination of pazopanib in combination with     paclitaxel prior to surgery results in a pathological complete response in females with     breast cancer.   "
228839|NCT00849485|"     The objective of this study is to compare the rate and extent of absorption of a test     formulation of Levetiracetam tablets versus the reference Keppra® administered as a 1 x 750     mg tablet under fed conditions.   "
228840|NCT00849511|"     The circadian system with its centre in the hypothalamus is involved in migraine     pathophysiology. Whether it plays a pivotal role is not clarified. The investigators     postulate that a destabilized circadian system may increase migraine attack susceptibility,     and that stabilization by supplying melatonin a migraine preventive effect will be achieved.      A previous open label study has shown effects that certainly warrant a placebo controlled     study.   "
228841|NCT00849524|"     This is a Phase II, open label, fixed dose, repeat injection, single institution study.     Eligible subjects will receive up to six doses of Ad-ISF35 injected directly into a selected     lymph node under ultrasound guidance. The primary goal is to determine and monitor clinical     and biological responses in patients treated with repeat intranodal injections of Ad-ISF35.   "
228842|NCT00849537|"     In this study, regressed proliferative diabetic retinopathy, very severe, severe and moderate     non-prolifrative diabetic retinopathy patients who were going to have a cataract surgery,     underwent a complete eye examination, OCT, FAG and color photography 2 weeks prior to their     operation. All patients divided in two: 1) control group (Phyco,PCIOL), 2) triamcinolone     treatment group (Phaco with PCIOL+IVT). One month after surgery a complete eye examination     will be done especially; IOP and endophthalmitis. A 6 month follow-up will be done for these     two groups and diabetic retinopathy progression will be checked.   "
228843|NCT00849550|"     The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard     treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors.   "
228844|NCT00849563|"     The primary objective of the study is to assess the clinical utility of a genetic test for     Type 2 diabetes risk in combination with standardized risk assessment compared with     standardized risk assessment alone, and to measure whether changes in perceived risk     following genetic testing for Type 2 diabetes risk are correlated with behavior change and     increased concern about risk for Type 2 diabetes.   "
228845|NCT00849576|"     The purpose of this study is to compare the effects of insulin VIAject with Regular Human     Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow.   "
228846|NCT00849589|"     The goal of this project is to adapt a computerized Screening and Brief Advice (SBA) protocol     that has demonstrated efficacy in reducing underage drinking among adolescent primary care     patients and then to test it in a multi-site randomized controlled trial (RCT).   "
228847|NCT00849602|"     The objective of this study was to evaluate the effect of chloroquine in the treatment of     patients with dengue.   "
228848|NCT00849615|"     Patients with locally advanced or metastatic gastric carcinoma or carcinoma of the     esophagogastric junction without prior palliative therapy will be treated with 8 cycles of     the FLOT scheme (up to 12 cycles if the response is favourable). Prior to enrollment a unique     and detailed clinical evaluation of the dissemination of the disease will be done which     includes a differentiated regard of the metastatic status. patients will be classified as     having either (A) locally advanced, (B) limited metastatic, or (C) extensive metastatic     disease. In arms A and B surgical intervention is planned if operability is reached. The     hypothesis is that by classifying patients more individually by the state of their disease,     patients in arm B will have a significantly prolonged overall survival compared to patients     in arm C.   "
228849|NCT00849628|"     The purpose of this study is to study factors (drugs, serum concentration of drugs,     nutrition, physical activity, demographics, diseases etc.) related to constipation and     diarrhea in nursing homes, and the effect of different laxative regimens.   "
228850|NCT00849641|"     Patients with decompensated liver cirrhosis exhibit numerous hemodynamic and microvascular     changes, i.e., low systemic blood pressure and peripheral vasodilatation. In addition,     alterations of tissue oxygenation are described in these patients.      Near-infrared spectroscopy (NIRS) has been proposed as a tool to quantify microvascular     dysfunction, for example in patients with sepsis (1) or after trauma (2). NIRS is a     non-invasive technique that uses the differential absorption properties of oxygenated and     desoxygenated hemoglobin to evaluate skeletal muscle oxygenation (3).      Up to the investigators' knowledge no data exist on NIRS measurements in patients with     decompensated liver cirrhosis.      Aims of this study are to evaluate:        -  Are there any changes in NIRS parameters in patients with decompensated liver cirrhosis          in comparison to other critically ill patients (matched to SAPS II Score) or healthy          individuals?        -  Is there a correlation with common accepted prognostic scores (MELD Score or indocyanin          green clearance) in decompensated liver cirrhosis patients and initial NIRS parameters?        -  Does the NIRS trend within the first three days of ICU care in decompensated liver          cirrhosis patients receiving fluid replacement therapy correlate with the course of          disease?             1. De Backer D, Creteur J, Preiser JC, Dubois MJ, Vincent JL. Microvascular blood flow               is altered in patients with sepsis. Am J Respir Crit Care Med. 2002 Jul               1;166(1):98-104.             2. Creteur J. Muscle StO2 in critically ill patients. Curr Opin Crit Care. 2008               Jun;14(3):361-6.             3. Creteur J, Carollo T, Soldati G, Buchele G, De Backer D, Vincent JL. The prognostic               value of muscle StO2 in septic patients. Intensive Care Med. 2007               Sep;33(9):1549-56.   "
228851|NCT00849654|"     The purpose of this study is to establish the safety and optimal dose of orally administered     PCI-32765 in patients with recurrent B cell lymphoma.   "
228855|NCT00849706|"     Long and unorthodox working hours (e.g. 24 hours or 23pm-07am shifts for doctors and nurses     respectively) combined with sleep deprivation, may affect cognitive functions such as     response time and concentration. These parameters may be tested using a driving simulator.     Apart from the obvious consequences of driving skills impairment for the medical personal, it     may serve as a quality assessment tool in evaluating the impact of workload and sleep     deprivation on medical staff's function. This study aims to assess the effect of work load     and sleep deprivation on medical staff's driving skills.   "
228856|NCT00849719|"     After major surgery, such as abdominal or thoracic surgery, the majority of patients     experience moderate to severe pain that may not be optimally controlled. Inadequate pain     relief may lead to complications that can hinder rehabilitation and slow recovery. Morphine     (MO) is the most commonly used opioid for the treatment of post-surgical pain (14). The     preferred method of administration nowadays is intravenous patient-controlled analgesia     (PCA). In contrast, Continuous infusion of intravenous morphine (CIVM) is seldom used in     Post-Anesthesia Care Units (PACUs) for acute postoperative pain, due to concerns of     cardio-respiratory deterioration, even though different studies have found this technique of     administration effective and safe (in terms of opioid-related symptoms.As part of our efforts     to improve postoperative pain management in the Tel Aviv Sourasky Medical Center's PACU, we     wish to determine if combining CIVM with IV PCA will be superior over IV PCA only for the     treatment of postoperative pain following major abdominal or thoracic surgery.Our hypothesis     is that the continuous infusion, even if given at a relatively low dose, would enable the     build-up of pharmacologically effective MO blood level, thus providing an overall better     control of pain.   "
228857|NCT00849732|"     This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine.     In Stage I subjects will be randomized to receive the vaccine at 1x10^9 viral particles/dose     (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10^10     vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10^9     vp/d, at 1x10^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1     Gag Vaccine will also be measured.   "
228858|NCT00849745|"     Autoimmune diseases present a special challenge to clinicians and the aim of this protocol is     to serve as a last-line effort for patients with unmanageable disease. The primary purpose of     this study is to assess feasibility in terms of toxicity and engraftment of a less toxic,     nonablative conditioning regimen of Campath-1H, moderate dose fludarabine, and     cyclophosphamide for patients with severe autoimmune diseases.   "
228859|NCT00849758|"     The goal is to study the biology of aging in breast cancer patients, and to study the impact     of chemotherapy on aging related blood biomarkers.   "
228912|NCT00850499|"     This is a randomized, open-label, active-control, multicenter Phase 2 study of     VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed     advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the     2 treatment arms (55 subjects per arm).   "
228860|NCT00849771|"     The purpose of this study is to contrast and evaluate the functional outcome of patients with     operative vs. nonoperative treatment of scapula fractures. The specific aim of this project     is to monitor the return to function of patients in both the operative and nonoperative     cohorts.      The potential impact is a clearer set of choices in treatment options for this type of     injury.   "
228861|NCT00849797|"     The objective of this study is to compare the rate and extent of absorption of a test     formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose     under fed conditions.   "
228862|NCT00849810|"     The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour     ambulatory blood pressure characteristics and basal metabolic rates in patients with     hypertension.   "
228863|NCT00849823|"     The purpose of this study is to test if sexual health interventions can reduce the incidence     of STIs among African American teens (15 to 21 years old). By doing this study, we hope to     help African American teens improve their condom use skills and encourage them to use condoms     more frequently. If the number of STIs in this population can be decreased, the health of     African American teen males will greatly improve. We also believe that sexual partners     (typically African American teen females) will also benefit.   "
228864|NCT00849836|"     The purpose of this study is:        -  To define The differences of bio-chemical phenotypes in chronic airway inflammatory          diseases.        -  To identify novel biomarkers in chronic airway inflammatory diseases as a screening,          diagnostic, or monitoring marker.   "
228865|NCT00849849|"     Previous gestational diabetes (GDM) predisposes affected women to diabetes. Pregnancy, in     essence, serves as a metabolic stress test and uncovers underlying insulin resistance and     ß-cell dysfunction. Cumulative incidence rates of type 2 diabetes (DM2) among women with a     history of GDM vary widely depending on the length of follow up and the underlying risk of     diabetes in the population. Like DM2, the incidence of postpartum diabetes appears to be     increasing The cumulative incidence of DM2 varied from 2.6 to > 70% in studies with     postpartum follow-up ranging from 6 weeks to 28 years. Among women with a history of     gestational diabetes, it is generally accepted that race, age, parity, family history of     diabetes, pre-pregnancy weight, postpartum obesity, and weight gain are risk factors for     developing DM2. Other suspected risk factors include smoking, physical inactivity, diet, and     drugs that adversely affect glucose metabolism. Despite the high and increasing rate of DM2     in Louisiana, the medical community does not have reliable estimates of the number of woman     living in southern Louisiana who develop diabetes subsequent to GDM. At Woman's Hospital, the     investigators had 8246 deliveries in 2007; 7873 mothers (95% of deliveries) were either     African American or Caucasian. Of this group of women, 665 were diagnosed with gestational     diabetes mellitus. Thus, around 8.5% of the African American and Caucasian women delivering     babies at Woman's Hospital in 2007 had a glucose abnormality. The incidence of diabetes and     impaired glucose metabolism in the immediate postpartum period and within 12 months after     delivery in this population is unknown. There are no long-term studies performed in Louisiana     that have compared the benefits of different screening strategies or evaluated an optimum     testing frequency after GDM to reduce the rate of DM2 and cardiovascular disease (CVD) in     these high-risk women. The investigators plan to use this study as an outreach effort to     provide screening for previous gestational diabetic mothers without adequate medical coverage     following delivery.   "
228866|NCT00849862|"     The objective of this study is to compare the rate and extent of absorption of a test     formulation of Levetiracetam and the reference Keppra® administered as a 1 x 750 mg tablet     under fasting conditions.   "
228867|NCT00849875|"     The purpose of this clinical trial is to find out how successfully, patients with progressive     metastatic cutaneous melanoma, are able to develop an immune response to injections with the     immunotherapeutic product GSK1572932A when given in combination with dacarbazine and evaluate     the safety of this combination.   "
228870|NCT00849914|"     MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length,     capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs     (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of     complementarity. miRNAs have recently been shown to play pivotal roles in diverse     developmental and cellular processes and linked to a variety of skin diseases and cancers. In     the present study the expression profiles for the two most important miRNA processing enzymes     Dicer and Drosha of actinic keratoses, basal cell carcinoma and squamous cell carcinoma are     compared to healthy skin tissue.   "
228871|NCT00849927|"     Objective: Symptomatic pan-labral or circumferential (360 degree) tears of the glenohumeral     labrum are an uncommon injury. The purpose of this study is to report the prospective     surgical results of circumferential lesions of the glenoid labrum using validated outcome     instruments.      Methods: From July 2003 to May 2006, 41 shoulders in 39 patients with mean age of 25.1 years     (range, 17 to 38) were prospectively enrolled in a multi-center study (3 surgeons) and     treated for a circumferential (360-degree) lesion of the glenoid labrum. There were 34 men     and 5 women, all with a primary diagnosis of pain and recurrent shoulder instability. All     patients underwent arthroscopic repair of the circumferential labral tear with a mean of 7.1     suture anchors (range, 6 to 9). The outcomes in 39 of 41 shoulders (92.7% follow-up) were     assessed at a mean final follow-up of 31.8 months (range, 24 to 53 months) with VAS pain and     instability scales (0 to 10), a physical examination, the Single Assessment Numeric     Evaluation Score (SANE), the American Shoulder and Elbow Surgeons Score (ASES), and the SF-12     score.   "
228872|NCT00849940|"     The aim of this study is calibrate (adjust and tune) the CAS FORE-SIGHT Near-Infrared     Spectroscopy (NIRS) monitor when used to measure the tissue oxygen saturation of internal     organs (StO2). This is a measure of the amount of oxygen carried by the blood within the     internal organs. In addition the study will assess the degree of similarities between StO2     and mean mixed venous oxygen saturation - a measure of the amount of oxygen carried in the     blood returning to the heart.   "
228873|NCT00849953|"     A prospective, post-approval registry study assessing subject rhinosinusitis symptomatic     status over time following treatment with FinESS Sinus Treatment using self-administered     quality of life survey data.   "
228874|NCT00849966|"     The investigators' study will involve the administration of either placebo or celecoxib to     children aged 2 to 18 years of age undergoing tonsillectomy and assessing pain relief, impact     on quality of life and side effect profile.   "
231259|NCT00879528|"     PET-based consolidation and donor-based therapy after rescue in patients with Hodgkin's     lymphoma refractory at first line therapy, or relapse early or late, undergone a second line     chemotherapy.   "
228875|NCT00849979|"     The goal of this study is to learn more about the symptoms that may occur in patients with GI     cancer. The types of GI cancer being studied are cancers of the stomach, liver, pancreas,     colon, and rectum. Researchers want to test a newly-designed questionnaire called the M. D.     Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) questionnaire.   "
228876|NCT00849992|"     Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to     compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data,     histology (skin analysis), epidemiological data and follow-up data.   "
228877|NCT00850005|"     This project addresses a vexing problem that has alluded the best efforts of the     medical/scientific community: treatment of resistant neuropathic pain. Neuropathic pain is     common and includes conditions such as diabetic neuropathy, post herpetic neuralgia and post     stroke pain and is believed to affect at least 3% of adults. Surveys of patients with     neuropathic pain indicate that 60% do not receive adequate relief with current treatment.     Results from recent laboratory and human studies reveal a new approach to treatment. This     approach is based on the findings that neuroinflammation appears to be involved in     development and maintenance of neuropathic pain. This study explores the effects of an     immune-modulating blood-derived product, intravenous immunoglobulin (IVIG), in treating     neuropathic pain. IVIG is thought to reduce neuroinflammation contributing to neuropathic     pain. If successful, the study will provide important insights into pain mechanisms and a     better understanding of how IVIG relieves neuropathic pain.      Hypotheses:        1. Reduction in neuroinflammation (NI) markers will co-vary with clinical indicators of          pain relief        2. Patients with higher levels of markers of NI will be more likely to respond to IVIG   "
228878|NCT00850018|"     Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease     that can cause intense pain episodes and may lead to organ failure. Preliminary studies have     shown that adults with SCD may have brain abnormalities that contribute to problems with     cognitive functioning, including attention and memory difficulties. This study will use brain     magnetic resonance imaging (MRI) and neuropsychological testing to examine the differences in     cognitive functioning in adults with SCD who are treated for anemia with monthly blood     transfusions for 6 months versus adults with SCD who receive usual care for 6 months.   "
228879|NCT00850031|"     The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will     provide an effective method for the correction of presbyopia in patients who have normal     distance vision but need a correction such as glasses or contact lenses to see clearly at     near.   "
228880|NCT00850044|"     The purpose of this study is to determine the pharmacokinetic and safety profiles of an     experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.   "
228881|NCT00850057|"     Primary Objectives        -  To determine the safety and maximum tolerated dose (MTD) of Adenovirus-CD154 (Ad-ISF35)          when it is injected directly into the lymph nodes of patients with CLL or SLL.      Secondary Objectives        -  To determine and monitor clinical and biological responses in patients treated with          injections of Ad-ISF35.        -  To determine how ISF35 works in CLL/SLL patients' cells.   "
228882|NCT00850070|"     This study is intended to provide a definitive test of the hypothesis that elevating     sapropterin (tetrahydrobiopterin, a cofactor for several key brain enzymes)concentrations in     the CNS will result in measurable improvements in core symptoms of autism in young     individuals, under age 6 years. The study will entail a double-blind, placebo-controlled     16-week intervention.   "
246712|NCT01080924|"     This study is aiming at evaluating whether low frequency ultrasound spectroscopy is a     sensitive tool to detect broncholytic effects in patients with obstructive airway diseases.   "
228883|NCT00850083|"     Objective To evaluate the accuracy of data acquisition by Health e pod device in measurement     of body temperature, to compare it to a standard body temperature measure equipment About 400     consecutive patients admitted to PEU in Assaf Harofeh Medical Center will compile the Study     Population.      Basic vital signs will be recorded on admission and during hospitalization as per the PEU     policy and not in particular for this study.      As a part of routine check-up all admitted patients undergo body temperature measure (oral or     rectal - as per the PEU policy and with PEU devices).      Following an explanation and patient agreement, eligible patients (and their legal guardian)     will sign informed consent and enter the study. The health e pod device will be applied to     measure body temperature, immediately after the standard temperature measure has been     performed by the PEU professional.   "
228884|NCT00850096|"     The purpose of this study is:        -  To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia,          assessed by continuous glucose monitoring data and serum fructosamine levels in patient          volunteers with Type 2 Diabetes.        -  To asses the safety and tolerability of Nauslin at 50 IU and 100IU doses in patient          volunteers with Type 2 Diabetes   "
228885|NCT00850122|"     This is a phase I open label multi-dose study to investigative the pharmacokinetics and     safety of cefazolin in infants <121 days of age and < 28 weeks gestation with suspected     sepsis. There will be two cohorts of 6 infants each: 1) >48 hours of age and ≤28 days and 2)     >28 days of age and <121 days of age. The study requires administration of the study drug     over 2 days followed by 1 week of safety monitoring. Six 200 µL pK samples will be obtained     over the 2 days of drug administration. The risks are reasonable vs. the benefits and have     been minimized appropriately. There may be benefit to the subjects (administration of     empirical antimicrobial therapy), and information from the study may benefit a large number     of other infants in whom the drug is currently being administered despite the lack of PK data     in this population.   "
228886|NCT00850135|"     Diabetic pregnant patients are at risk for adverse pregnancy outcomes, including larger than     expected fetuses and unplanned operative deliveries, due to elevated blood glucose levels.     the one-hour glucola test is currently used to screen pregnant patients for gestational     diabetes. This involves ingesting a 50-gram glucose load, followed by a blood test one hour     later. We wish to compare 7-day continuous glucose monitoring to the one-hour glucola test,     and determine which one correlates better with adverse pregnancy outcomes as well as which     one more accurately identifies patients at risk for adverse pregnancy outcomes.   "
228924|NCT00850668|"     The purpose of this study is to evaluate the safety and side effects of a study product that     contains recombinant modified peanut proteins (EMP-123) in healthy and peanut-allergic     participants. This is a first in human study.      As of November 2009, this study is no longer recruiting healthy volunteers and will only be     recruiting individuals with peanut allergies.   "
228887|NCT00850148|"     This study will be performed on patients who come to labbafinejad ophthalmic clinic from 20     March 2008. Keratoconus diagnosis will be determined by clinical finding in slit lamp,     keratometery and topographic characteristics. Patients will be randomly placed in group A and     B. In group A, Anwar surgical method and in B, Melles surgical method, will be done. This is     not a blind study due to surgeons' knowledge. All patients will receive Btamethazone drop and     Chloramphenicol every 6 hours and will be tapered in two months. In the end anatomical     results, complications, BCVA, UCVA, astigmatism, endothelial cell numbers will be compared in     two groups by using specular microscopy. Contrast sensivity, central corneal diameter,     interface wrinkling and opacity will be measured by metrovison, Confoscan, Photoslit in     months 3, 6, 12, respectively and will be evaluated afterwards.   "
228888|NCT00850161|"     The purpose of this study is to determine if glucose peaks higher and earlier after a meal     when a patient is given intranasal insulin instead of conventional insulin treatment.   "
228889|NCT00850174|"     The objective of this study is to evaluate the comparative bioavailability between     Oxcarbazepine 600 mg Tablets (test) and Trileptal® 600 mg Tablets (reference) after a     single-dose in healthy subjects under fasting conditions.   "
228890|NCT00850187|"     The purpose of this study is to investigate the efficacy and safety of autologous     transplantation of Bone Marrow Mesenchymal stem cells (MSCs) mixed with collagen I scaffold     in patient with Knee cartilage defects and osteoarthritis   "
228891|NCT00850200|"     The purpose of this study is to reduce the risk of radiation related side effects and     complications by treating with radiation (protons or photons) that exposes less of normal     organs to low dose radiation.   "
228892|NCT00850213|"     The Redes registry is set up to document the overall clinical performance and costs of the     Endeavor Resolute coronary stent in a real life subject population of 450 patients that     require a stent in Spain. Primary objectives are the overall cost for patients during initial     hospitalization and at 1-year follow-up, as well as the MACE rate at 30 days, 6 months and 12     months post procedure.   "
228893|NCT00850226|"     This study proposes to compare the effectiveness of an acceptance-based intervention and a     cognitive control-based intervention for coping with test anxiety in nursing students during     the HESI (Health Education Systems, Inc.) examination.      Subjects will be randomized to receive either the CT or the ACT condition. In both     conditions, subjects will receive an education on test anxiety to inform them about what test     anxiety is and why it occurs. Then, the different conditions will receive the respective     treatment of either CT or ACT. The study is considered minimum risk because the nursing     students will only be exposed to an amount of anxiety that is typical of their testing     experience. Both conditions will meet three times, with each session lasting approximately     one and a half hours. The purpose of the treatment is to provide subjects with tools to help     them cope with their test anxiety.   "
228894|NCT00850239|"     The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as     evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety     and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26     weeks.   "
228895|NCT00850252|"     This study will assess the safety and efficacy of a completely autologous and completely     biological tissue engineered blood vessel (TEBV) called Lifeline™ used as an arteriovenous     fistula for dialysis access.   "
248103|NCT01097096|"     This study will assess the safety, tolerability and Abeta-specific antibody response of     repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's     Disease.   "
228896|NCT00850265|"     Combined inhaled treatment with long acting adrenergics and steroids in an unique inhaler     plays an important role in the management of non-mild asthma. Some studies have demonstrated     that the use of spacers achieve better lung deposition and decrease the number of side     effects. Recently a new combined treatment for asthma has been developed (extrafine     formoterol plus beclomethasone dipropionate). The small size of the extrafine particles of     this new combination get the small airway and theorically improve their positive effect. Some     authors have stated that the use of a spacer with extrafine particle could decrease the     effectiveness of this treatment due to the adhesion of particles on the walls of the spacer     because of the electrostatic characteristics of plastic spacers. However, there are no     clinical or functional studies demonstrating the role of this phenomena in the control of     asthmatic patients. The investigators' hypothesis is that the benefit of using spacers with     this new treatment is at least equal in magnitude than the loss of efficacy because of the     adhesion of particles on the wall of the spacer and then the investigators hypothesized that     the use of spacer with extrafine formoterol-beclomethasone do not suppose a decrease in     clinical or functional control in stable moderate-severe asthma patients.   "
228897|NCT00850278|"     The primary objective of this study is to assess the efficacy of the radiopharmaceutical     3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a tracor of cell proliferation, using Positron     Emission Tomography (PET) imaging for the tumor diagnosis and prognosis in a group of 50     patients with different type of brain tumors.[F-18]FLT PET imaging will be compared to the     current used imaging techniques of MRI, spectroscopy imaging, PET imaging using [11C]MET     tracer, immunohistochemical analysis and clinical parameters.   "
228898|NCT00850291|"     Including 89 randomised patient, the studies aim is to determine whether an economisation     and/or improvement in terms of operating time, drainage fluid, blood loss, time of     hospitalisation can be found using an electrosurgical sealing device versus traditional     surgical methods such as stitches an ligations.The study is performed for patients undergoing     partial pancreatoduodenectomy.   "
228899|NCT00850304|"     Our purpose in this study is to explore the feasibility of treatment of non promyelocytic     Acute myeloid leukaemia on elderly patients. We select ten patients with age further than 60     with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten     days in month. We will assess overall response rate and overall survival in end of one year.   "
228925|NCT00850681|"     This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01%     and it's vehicle on normal skin.   "
228926|NCT00850694|"     Sub-clinical vitamin D deficiency is a commonly unrecognized disorder in obese adolescents.     The investigators hypothesize vitamin D deficiency will be highly prevalent in obese     adolescents and those who are vitamin D deficient will be more insulin resistant.   "
229073|NCT00839319|"     The purpose of this investigational study is to determine how much male hormone,     testosterone, is necessary to maintain sperm production in the testis. This knowledge will be     used to help in the development of a safe male hormonal contraception.   "
228900|NCT00850330|"     A drug interaction (DI) is the mutual action of two drugs in a way that they can increase     their action, even to a toxic level, or reduce it to its minimum.      People elder than 65 years old have theirs biological ability to metabolized and eliminate     drugs impaired. Even more, they tend to suffer from many diseases, are treated for many     physicians, and receive many drugs for those conditions. If hospitalized older people are     prone to receive a greater number of drugs. This scenario is the worst to suffer from adverse     drug events and DI, which in turn compromise more the health and even life of hospitalized     older people.      Many computerized strategies have been developed to prevent those problems. In this trial the     investigators use on line software to early detect DI that could endanger health or life of     hospitalized older patients.   "
228901|NCT00850343|"     The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol     when administered without coadministration of methotrexate over the long term in Japanese RA     patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of     different dosing regimens on the safety and efficacy of certolizumab pegol in American     College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003.   "
228902|NCT00850356|"     The purpose is to determine the economic, clinical and quality of life outcomes of bariatric     surgery and describe the consequences of protracted wait-times (~ 2 years) for this     procedure.   "
228903|NCT00850369|"     Pulmonary hypertension, a complication associated with an increased risk of death, is common     in patients with sickle cell disease. Despite its frequency, there remains no standard     treatment for this complication in patients with sickle cell disease.      In this small study, the investigators will evaluate the effect of monthly transfusion of red     blood cells to patients with sickle cell disease-associated pulmonary hypertension. The     investigators speculate that by increasing the hemoglobin level and decreasing the amount of     sickle red blood cells, these patients would experience improvements in their PHT.   "
228904|NCT00850382|"     This is a Phase Ib/IIa open-labeled multi-center trial evaluating the feasibility of     dasatinib given after standard induction therapy with daunorubicin (DNR) and cytarabine     (ARA-C), after consolidation therapy with high-dose cytarabine (HDAC), and as single agent in     a one-year maintenance therapy in patients with newly diagnosed CBF AML.      82 patients with newly diagnosed CBF AML will be enrolled at AMLSG study centers.      All AML patients will be assessed for the CBF fusion genes via the central laboratory of the     AMLSG within 48 hours of diagnosis of AML, and only patients with CBF AML will be enrolled     into the study.   "
228905|NCT00850395|"     Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical     practice and obtain information about the quality of life of patients using CELSENTRI®.   "
228938|NCT00850850|"     Recovery after general anaesthesia is often prolonged in the elderly. This group is     particularly exposed to post-operative confusion. This has negative personal consequences as     well as consequences for the postoperative care for these patients.      The hypothesis is that physostigmine will decrease the amount of time in the post-anaesthesia     care unit (PACU ), the postoperative amount of pain and shivering and finally post-operative     confusion.   "
230431|NCT00862719|"     The main purpose of this trial is to study whether the drug sitagliptin can be given safely     to patients undergoing umbilical cord blood transplantation to speed up engraftment (recovery     of blood counts after transplant).   "
228906|NCT00850408|"     Weakness of the arm and hand results in long-term disability for many persons who suffer a     stroke. After the initial recovery phase, only limited gains are achieved by retraining the     weak limb to perform daily tasks. However, new treatment strategies such as repetitive     transcranial magnetic stimulation (rTMS) show promise for enhancing motor recovery after     stroke. rTMS is a noninvasive technique for modifying brain activity that aims to improve     motor function by correcting abnormal patterns that occur after stroke. We believe that     giving rTMS right before a therapy session will prepare the brain so that the patient is     better able to participate in and benefit from training of the hand and arm. The goal of this     study is to test how well this new strategy works to improve recovery in people who have mild     to moderate weakness of the arm and hand after stroke.      Participants will receive magnetic stimulation of the movement area of the brain just prior     to arm and hand training for a series of eight sessions. We will evaluate changes in hand and     arm function after the intervention and one month later to see if the changes are maintained.     We will also test whether some groups of people benefit more than others from the     intervention. If improvements in hand and arm function are observed after the intervention,     we will test it more rigourously in a future clinical trial in which participants are     randomly assigned to different treatment conditions. This research will show whether brain     stimulation can be used to improve the effectiveness of rehabilitation care.   "
228907|NCT00850421|"     The purposes of this study are to assess whether subjects treated with BOTOX will:        1. have a decrease in the frequency and intensity of migraine headaches        2. experience improvements in quality of life        3. experience a reduction in the frequency of health care services obtained.   "
228908|NCT00850447|"     The purpose of this study is to gather feasibility data on cognitive remediation therapy     (CRT) as an alternative intervention for PTSD. CRT is a standardized intervention that     involves performing cognitive exercises to improve attention, processing speed, and memory     through practice. Although the primary objective will be to determine the effect of CRT on     cognitive functioning in PTSD, data on PTSD symptom severity and other clinical measures will     also be examined to assess whether and to what degree cognitive alterations and symptom     severity might be linked. CogPack, a computer-based form of CRT, would be employed for this     project. Participants will be randomized to receive CRT or to play the video game Tetris as a     control condition.   "
228909|NCT00850460|"     The proposed study will focus on possible effects of statins on muscle strength and why they     become tired more easily, quality of life, and measurements to understand why muscles are not     able to fully utilize fats. The investigators are specifically interested in statin users and     the impact of muscle symptoms on daily activities and quality of life.      This study hypothesize that patients with likely statin-associated myopathy have a metabolic     dysregulation in fuel utilization such that compared to patients continuing statins, those on     placebo will show:        1. improved Individualized Neuromuscular Quality of Life (INQoL) and Short Form-36 (SF-36)          scores (primary end point)        2. alleviation of muscle symptoms,        3. increased utilization of fatty acids as a fuel source reflected by the metabolic test          results        4. decreased intramyocellular lipid (IMCL)        5. improved insulin sensitivity.   "
228910|NCT00850473|"     This study is being done to determine if a picture taking test of the heart, positron     emission tomography/computed tomography (or cardiac PET/CT), can identify the blockages in     the heart arteries that lead to heart attacks when compared to the standard of heart     catheterization.   "
228911|NCT00850486|"     The purpose of this study is to verify the efficiency of the HyperQ technology compared with     standard ECG analysis in detecting exercise induced ischemia in women who are referred to     coronary angiography.   "
228913|NCT00850512|"     Study phase: Phase II Investigational product, dosage, and route of administration:     Ibritumomab tiuxetan (Zevalin) is composed of a murine IgG1 monoclonal antibody     (ibritumomab) covalently bound to the chelating agent tiuxetan. To prepare the active     therapeutic agent [90Y]-ibritumomab tiuxetan, the antibody is chelated with the β-emitter     yttrium-90 chloride immediately before intravenous administration. Treatment with     [90Y]-ibritumomab tiuxetan is preceded by an infusion of rituximab (Rituxan, Mabthera) in     order to optimize the biodistribution of radiolabeled antibody by depleting CD20 positive     B-cells. Rituximab is a chimeric human/murine IgG1 monoclonal antibody. The Zevalin study     regimen is given as an infusion of rituximab 250 mg/m2 and (where biodistribution imaging or     dosimetry is compulsory) 185 MBq (5mCi) of [111In]-ibritumomab tiuxetan on Day 1 followed 7     to 9 days later by a single dose of 14.8 MBq/kg (0.4 mCi/kg) of [90Y]-ibritumomab tiuxetan,     maximal dose of 1184 MBq (32 mCi), preceded by 250 mg/m2 of rituximab.      Reference product, dosage, and route of administration: Not applicable Indication: stage     II-IV diffuse large B-cell lymphoma (DLBCL) patients after 4 cycles of CHOP21-Rituximab     (CHOP21-R) Study objectives: Evaluation of efficacy and safety of [90Y]-ibritumomab tiuxetan,     as well as assessment of quality of life Patient population: Patients more than 60     years-of-age with DLBCL after 4 cycles of treatment with CHOP21-R Study design: Prospective,     multicenter, open-label study designed to treat patients with a sequential front-line     treatment represented by: 4 cycles CHOP21-R plus Zevalin Duration of treatment: Four months     for CHOP21-R and two treatment days one week apart followed by a 12-week safety period for     Zevalin Duration of study: Estimated duration of study is 18 months Methodology: Primary     efficacy parameter: Overall response rate and complete response rate. Secondary efficacy     parameters: Overall survival, disease-free survival, health-related quality of life. Safety     parameters: Vital signs, adverse events (AEs), hematology, blood chemistry, and     immunoglobulin levels Number of study centers: Planned total of 10 study centers in Italy     Total number of patients, statistical rationale provided: Expected total of approximately 55     patients. The final sample size is based on the number of events observed for the primary     efficacy endpoint as calculated in the sequential statistical model. Adverse events: AEs     observed, mentioned upon open questioning and/or spontaneously reported will be documented.      Planned start and end of recruitment: Start of recruitment: 19/12/2006. End of recruitment:     04/11/2008.      Manufacturer(s) of the investigational /reference product(s): Ibritumomab tiuxetan is     manufactured by Biogen IDEC, San Diego, CA and Cambridge, MA, USA. The isotopes yttrium-90     will be provided by European suppliers. There is no reference product in this study.   "
228914|NCT00850538|"     The purpose of the study is to investigate protein and gene expression among damaged knee     tissues. We will perform MRI's on subjects prior to total knee replacement to identify the     location of bone marrow lesions. Connective tissues including tendon, ligament, and meniscus     specimens normally discarded from total joint replacements will be used for live cell     harvest, and protein and gene expression analyses of tissue or cultured cells.   "
228950|NCT00851019|"     Regular physical activity is important for the treatment of type 2 diabetes, but it is often     not sustained for many reasons, including lack of interest. New video games that involve     physical movement (exergames) may help in this regard. This study will compare the     exergame Dance Dance Revolution (DDR) with traditional treadmill exercise on blood sugar     control among sedentary, overweight or obese adults with type 2 diabetes.   "
228989|NCT00851539|"     The design of this randomized controlled trial (RCT) is to test the effectiveness of a     post-test behavioral video in educating adolescents about HIV transmission and affecting     their intentions to engage in risk-reduction behavior.   "
228915|NCT00850551|"     This study will be performed at the University of Washington. Forty subjects with Cystic     Fibrosis will be enrolled, with 20 randomized into the usual care arm and 20 randomized into     the intervention arm. All subjects will be enrolled for 6 months and have 3 study visits. One     at baseline, midpoint, and final. The intervention arm subjects may have more study visits     depending on their respiratory symptoms.      The intervention arm subjects will perform home spirometry twice a week with a PiKo-6 hand     held spirometer. They will also have a home-based telemonitoring system connected to their     phone line. They will be prompted twice a week to answer questions regarding their health via     the telemonitor.      Subjects who are not able to utilize the home-based telemonitoring system will answer the     questions regarding their health via the internet from their home computer.      If the subject's spirometry falls by greater than 10% from baseline or the CF respiratory     symptoms change in 3 or more of the 8 respiratory symptoms captured by the telemonitor     questionnaire, the subject will be called by the research staff and clinically evaluated by     the study PIs within three days.      The usual care subjects will continue with their routine care at the University of Washington     CF Clinic.   "
228916|NCT00850564|"     The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing     Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will     increase GH pulse height and will not affect insulin sensitivity.   "
228917|NCT00850577|"     The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab,     both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects     with recurrent or advanced non-squamous NSCLC   "
228918|NCT00850590|"     Studies investigating single doses of different NRL001 formulations showed     formulation-dependent differences in exposure, even though they had similar effects on mean     anal resting pressure (MARP). This study is a first step in investigating the hypothesis that     a better balance between desired anal effects and undesired systemic effects can be reached     with a NRL001-slow release suppository than with previously studied formulations.      To this purpose, single doses of 5 to 15 mg, administered as 1 g and 2 g suppositories, are     being investigated with regard to their pharmacokinetics and systemic effects (blood     pressure, pulse rate, electrocardiographic heart rate).   "
228919|NCT00850603|"     The objective of this trial is to study the administration of the Menomune vaccine given     intradermally and low-dose subcutaneously versus standard subcutaneously. This study will     describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard     dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose)     and a low dose (2/10th of standard dose) subcutaneously.      The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal     (ID) routes at different dosages   "
228920|NCT00850616|"     A study to assess the general safety and tolerability of the administration of the 3-dose     regimen of the MRKAd5+6 trigene vaccine   "
228921|NCT00850629|"     The investigators here propose to perform a collaborative clinical research effort including     a randomized controlled trial investigating the mechanisms of weight maintenance and their     relation to a lifestyle intervention in children, adolescents and adults. The detailed     investigation and analysis of the variability and dynamics of the endocrine circuits     responding to a negative energy balance and weight loss will be accompanied and enhanced by     specific clinical projects targeting peripheral and central-nervous aspects of hormonal     counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and     potential therapeutic approaches will be studied.   "
228922|NCT00850642|"     A randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect     of treatment with GSK2190915, a FLAP inhibitor, as add-on to current inhaled corticosteroid     therapy in patients with moderate to severe asthma with elevated sputum neutrophils.   "
228923|NCT00850655|"     This is a study of the genetics of malaria transmission by the mosquito vector in Africa,     Anopheles gambiae. The study focuses on the mosquito vector, not the human subjects infected     with malaria. DNA extracted from infected mosquitoes will be analyzed genetically by     microsatellite and single-nucleotide polymorphisms (SNPs) to identify mosquito genes that     control mosquito resistance to malaria parasites.   "
229105|NCT00839748|"     The purpose of this study is to collect information in order to identify people who have     asthma and who may be good candidates to participate in one of the future asthma studies to     be conducted at The Ohio State University Asthma Clinical Research Center.   "
228927|NCT00850707|"     The aim of the present study was to investigate patients free of active infection and/or     thrombosis to assess if the type of vascular access (AVF, AVG, TCC), could influence:        1. the levels of serological markers of inflammation (CRP, IL-6, TNF-a);        2. the degree of expression on monocyte surface of inflammation and immune response          modulating molecules: CD14, CD32 and CD44.        3. the amount of monocytic cells expressing a senescent phenotype (CD14 and CD32).   "
228928|NCT00850720|"     The goal of this study is to evaluate specific hormone levels in children undergoing heart     surgery in order to identify patterns associated with any unstable vital signs. The data     collected will provide preliminary answers to the question Are hormone values a determining     factor for drug administration and dosing levels? and help establish the benefits of routine     steroid and hormone administration. Sixty subjects will be enrolled. Blood samples will be     drawn before the surgery,and again nine hours after surgery for analysis. Other patient data     such as medications, vital signs, routine lab values and treatments will also be analyzed. As     our current standard of care includes routine doses of steroids, we believe this study will     increase our general knowledge and improve the care of these critically ill children. The     study will also provide the foundation needed for grant support from the American Heart     Association, allowing for future larger scale studies.   "
228929|NCT00850733|"     The specific aim of this study is to evaluate the safety and efficacy of each of 2 dosages of     BOTOX® (200 U or 300 U) compared to placebo injected into the detrusor for the treatment of     urinary incontinence caused by neurogenic detrusor overactivity in patients who have not been     adequately managed with anticholinergic therapy.   "
228930|NCT00850746|"     This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy     adults.   "
230807|NCT00867711|"     The aim of the present study is to investigate the molecular predictors of pemetrexed and     carboplatin response in tumor samples of a series of MPM patients extracting the DNA and     genotyping for the TSER polymorphism.   "
228931|NCT00850759|"     Pedestrian injuries are among the leading causes of morbidity and mortality in American     children ages 7-8, but existing behavior-oriented interventions achieve only modest success.     One limitation to existing interventions is that they fail to provide children with the     repeated practice needed to develop the complex perceptual and cognitive skills required for     safe pedestrian activity.      Virtual reality (VR) offers a highly promising technique to train children in pedestrian     safety skills. VR permits repeated unsupervised practice without risk of injury; automated     feedback to children on success or failure in crossings; adjustment of traffic density and     speed to match children's skill level; and an appealing and fun environment for training. The     proposed research is designed to test the efficacy of virtual reality as a tool to train     child pedestrians in safe street-crossing behavior.      A randomized controlled trial will be conducted with four equal-sized groups of children ages     7-8 (total N = 240). One group will receive training in an interactive and immersive virtual     pedestrian environment. The virtual environment, already developed, has been demonstrated to     have face, construct, and convergent validity. The second group will receive pedestrian     safety training via video and computer strategies that are most widely used in American     schools today. The third group will receive what is judged to be the most efficacious     treatment currently available, individualized behavioral training at streetside locations.     The fourth and final group will serve as a no-contact control group. All participants in all     groups will be exposed to a range of field- and laboratory-based measures of pedestrian skill     during baseline and post-intervention visits, as well as during a six-month follow-up     assessment. Primary analyses will be conducted through linear mixed models designed to test     change over time in the four intervention groups. We hypothesize all children in active     learning groups will increase pedestrian safety skills, but the largest increase will be     among children in the virtual reality group.   "
228932|NCT00850772|"     Ovarian cancer patients are often at risk of malnutrition because of weight loss, lack of     appetite and reduced food intake. Being malnourished can contribute to the incidence and     severity of cancer treatment side effects and increase the risk of infection. Currently     patients with advanced ovarian cancer do not receive early nutrition using a feeding tube.      The purpose of this study is to compare enteral nutrition along with standard post-surgery     care against current standard post-operative care alone. This study will see if early     nutrition using a feeding tube has an impact on length of hospital admission, recovery from     surgery, complications from surgery, nutritional status and ultimately a reduction in     treatment costs in people with Advanced Epithelial Ovarian Cancer (EOC). Primary Peritoneal     Cancer (PPC) or Fallopian Tube Cancer. Nutritional support has been shown to ;        -  Prevent and treat under-nutrition,        -  Enhance anti-tumour treatment effects,        -  Reduce adverse effects of anti-tumour therapies,        -  Improve quality of life.   "
228933|NCT00850785|"     This is a pilot single institution study of DRibble vaccination + GM-CSF in patients with     stage IIIB or IV NSCLC who have undergone 0-1 chemotherapy regimens for metastatic disease.     The primary objective of this trial is to evaluate immune responses induced by autologous     DRibble vaccine in vivo and in vitro and against autologous and allogeneic lung cancer cells.   "
228934|NCT00850798|"     Aims/hypothesis:      Populations worldwide are aging and type 2 diabetes is common in individuals aged >80 years.     The important issue that needs to be considered is whether tight glycemic control is benefits     for elderly patients with type 2 diabetes. The benefits of intensive glucose control remain     uncertain for the heterogeneous population of older diabetic patients due to a lack of     clinical trial data evaluating the benefits of long-term intensive glucose control in older     patients. This study is designed to provide reliable evidence on the balance of benefits and     risks conferred by intensive glucose control in elderly patients with type 2 diabetes     Methods: This is a prospective, randomized, open-labeled, controlled design to assess the     benefits of treating elderly patients with type 2 diabetes. The study will include 208     elderly patients with type 2 diabetes and follow-up for 5 years. Eligible patients are     randomized to receive intensive (A1C <7.0%) or conservative (A1C around 8.0%) glycemic     control. The primary study outcomes are a composite of macrovascular events and a composite     of microvascular events, considered both jointly and separately. The secondary outcomes are     death from any cause, death from cardiovascular causes, total coronary events, total     cerebrovascular events, heart failure, peripheral vascular events, all cardiovascular events,     and hospitalization for 24 hours or more.      Expected results: This study is designed to provide reliable evidence on the balance of     benefits and risks conferred by intensive and conservative glucose control in elderly     patients with type 2 diabetes. Once completed, this trial will clearly influence the     management of elderly patients with type 2 diabetes, regardless of the results.   "
228935|NCT00850811|"     This Phase 1 study is designed to determine the photoirritation potential of PEP005 Gel,     0.01% when application is followed by light exposure.   "
228945|NCT00850941|"     The goal of this clinical research study is to create a registry (research database) of     clinical data about patients who receive radiation therapy, with or without hormone therapy,     to treat prostate cancer that has come back after surgical removal of the prostate. This     treatment is standard and the actual treatment is not part of this protocol.      Researchers want to collect data and use this registry to learn about the long-term status of     prostate cancer after these treatments.   "
228936|NCT00850824|"     As type 2 diabetes prevalence increases in the United States, the burden of diabetes falls     more on groups with greater barriers to care, such as language and cultural differences, and     lower economic resources. Healthy People 2010 targeted diabetes as one of six diseases for     the elimination of racial and ethnic health disparities. These disparities extend to the US     Territory of American Samoa, where the proportion of adults >18 years with diabetes was 19.6%     in 2002, compared to 6.4% of US adults. There have been no reported diabetes interventions in     Samoans in the US. The overall purpose of this application is to translate recent advances in     diabetes care into clinical practice for the American Samoan community by improving methods     of health care delivery and methods of diabetes self management. We will conduct a randomized     clinical trial to test the effectiveness of a community health worker (CHW) and primary-care     coordinated intervention to provide outreach, education and support to 352 type 2 diabetes     patients and their families in American Samoa. The CHW intervention will utilize     evidence-based algorithms and protocols to prompt risk behavior interventions, communication     with health care team, and visit schedule. The individual treatment action plans are also     guided by the Precede-Proceed Model. The outcomes at a one-year follow-up will include     glycosolated hemoglobin (HbA1c), cardiovascular disease risk factors, diet and exercise     behaviors, and adherence to diabetes care guidelines. The study hypothesis is that diabetes     patients in the CHW trial arm will have lower HbA1c levels, lower cardiovascular disease risk     factor levels, increased exercise behaviors and healthy dietary intakes and greater adherence     to diabetes care such as adherence to prescribed medications, keeping medical appointments     for diabetes care and specialty referrals. The intervention builds upon best clinical     practices for CHWs in diabetes care by translating effective strategies to American Samoans,     while also extending prior CHW research, by using a model that is potentially replicable in     other ethnic minority populations suffering the burden of diabetes.   "
228937|NCT00850837|"     Topical microbicides, substances that kill microbes, are being studied to prevent sexual     transmission of HIV and other disease pathogens. In the future, topical microbicides may be     applied vaginally to prevent both acquisition and transmission of HIV and other sexually     transmitted infections (STIs). The purpose of this study is to compare the safety of daily     applications of Acidform lubricant and HEC gel in healthy women at low risk for HIV infection     and assess the effect of a microbicide candidate on the natural immunity women have to STI     pathogens.   "
228939|NCT00850863|"     COPD is ranked number 3 by the WHO list of important diseases worldwide and is the only     disease with increasing mortality. The pathogenesis of cigarette smoke-induced COPD is     obscure, therefore more insight is needed to design effective anti-inflammatory agents.     Recently it has become clear that cigarette smoke-induced inflammation is not only present in     the lungs but also in the blood, and that this systemic inflammation has important     consequences for the clinical expression of COPD. The investigators hypothesize that healthy     individuals who are susceptible to cigarette smoking demonstrate a higher and aberrant     systemic inflammatory response to cigarette smoke. This susceptibility is caused by     heterogeneous factors and is associated with various polymorphic genes that interact with     each other and with the environment.      Objective:        -  To study systemic inflammation in individuals who are or are not susceptible to develop          COPD.        -  To characterize the switch to chronicity of the systemic inflmmatory response in COPD        -  To determine whether the type and severity of the systemic inflammation contributes to          the clinical outcome of COPD        -  To compare between subjects who are or are not susceptible to develop COPD in peripheral          blood, the corticosteroid responsiveness in vitro, and to unravel underlying mechanisms.        -  To study the role of candidate genes that may play a role in the development of fixed          airway obstruction, and to identify clues for patient's responsiveness to specific drugs        -  To develop new biological and clinical markers for the early diagnosis and monitoring of          COPD        -  To define possible mediators involved in the early induction of COPD in susceptible          smokers, and to define new drug targets   "
228940|NCT00850876|"     Nasal continuous positive airway pressure can cause nasal side effects which can compromise     compliance to therapy. Humidifiers can attenuate this effect. However, the mechanism by which     humidified CPAP alleviates nasal symptoms has never been assessed objectively in OSA     patients. Therefore, the purpose of this study is to examine the effect of humidified CPAP on     nasal airway physiology with combined measurements of nasal resistance and level of     inflammatory markers. The investigators' hypothesis is that the addition of heated     humidification in CPAP decreases nasal airway resistance and nasal mucosal inflammation     markers and thus, ameliorates nasal symptoms of OSAS patients.   "
228941|NCT00850889|"     Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with     Restylane in the correction of nasolabial folds.   "
228942|NCT00850902|"     The purpose of this study is to apply a different incubator humidity strategy at birth to     decrease morbidity and mortality in extremely low birth (1000 g or less) infants.   "
228943|NCT00850915|"     Isoniazid preventive therapy (IPT) is a well studied clinical intervention for primary and     secondary prevention of active tuberculosis (TB) after infection with Mycobacterium     tuberculosis. It is widely used in industrialized countries in TB outbreak management,     focusing on high risk groups such as close contacts in the family, in congregate settings,     and in the workplace amongst others. Individuals infected with Human Immunodeficiency Virus     (HIV) have a markedly higher risk of acquiring a TB-infection and developing consequently     active TB, making HIV-infected individuals a target population for IPT. Studies of IPT in HIV     infected persons in the nineties demonstrated the efficacy of IPT in the prevention of active     TB in Sub -Saharan Africa and more recent studies suggest that the protective effect remains     present in individuals on antiretroviral therapy.      Despite the proven efficacy of IPT this intervention has not been taken up by most HIV and TB     control programmes in Africa where the burden of TB/HIV is highest. The reasons for the low     uptake of IPT are many and varied but include fears of expansion of isoniazid resistance and     subsequently the development of multi -drug resistant TB with widespread use of IPT.     Additionally screening protocols for excluding active TB and selecting persons for IPT have     not been uniformly agreed upon. There have also been concerns that programmes designed to     provide IPT may shift TB control programmes from their primary responsibility of finding and     treating active TB. Finally it has been unclear as to which programme, between the HIV and     the TB control programme, has the primary responsibility of managing the provision of the IPT     intervention.      The World Health Organization and other technical agencies engaged in global TB control have     recently re-emphasized the need to scale up IPT. In this proposal we outline an operational     research study to evaluate the introduction of IPT at community level and to measure its     effectiveness at preventing TB. The study is based on the context of expansion of     Community-Based Direct Observed Therapy Short Course (CB-DOTS), home-based care and the     concept of HIV prevention with positives (PwPs), where there is a real opportunity to focus     on the household as a source of HIV-associated tuberculosis.      The study is designed as a cluster randomized trial. It compares the incidence of TB in     household contacts including children under 5 of identified TB/HIV co-infected patients, who     received IPT through proactive community intervention and those in a control group where the     community was handled in the usual way. In the intervention group household contacts of     index cases of HIV positive, smear positive PTB will be visited at home and consenting     contacts will be screened for active TB using a simple questionnaire. Those found to be fit     will receive isoniazid 300mg (5 mg per Kg for children) once daily for 6 months, regardless     of the HIV-status. Those found not to be fit will be referred for further evaluation at the     nearest TB diagnostic centre. In the control group, routine care following national     guidelines will be offered. This consists of contact invitation and assessment of eligibility     for IPT, especially, in children less than 5 years. Both groups will be followed up monthly     through household visits. Follow up will be for a total of 24 months including the six months     when IPT is provided.      A confidential HIV screening test will be provided to all consenting contacts in both     intervention and control group after appropriate counseling.      The primary outcome is the incidence of TB in the intervention and control household     contacts. The difference in incidence between the two groups is a measure of efficacy of the     intervention. In addition the efficacy of the intervention will be estimated stratified by     HIV status of household contacts if data allows. Secondary outcomes are the incidence of     adverse events, the incidence of TB-related symptoms, measures on the uptake of IPT     (proportion of contacts starting and discontinuing IPT, treatment adherence) and programmatic     indicators, i.e. percentage of persons eligible for IPT and resources needed.   "
228944|NCT00850928|"     Postoperative cognitive dysfunction (POCD) can be a serious complication. The development of     therapeutic strategies for the prevention and treatment of this condition requires the     identification of subgroup of patients with the greatest incidence of POCD. Several     retrospective analyses have raised the possibility that surgery is a risk factor for the     accelerated progression of Alzheimer's disease (AD). Moreover, there is increasing evidence     that inflammatory mechanisms are involved in the pathogenesis of AD. Major surgery can be     associated with a profound systemic inflammatory response. Consequently, it is reasonable to     suggest that there is a link between major surgery and the postoperative development of AD in     patients who are already at high risk for this complication, e.g. the elderly with mild     cognitive impairment. In addition, there are several laboratory investigations that suggest     that anesthetic agents increase amyloid peptide levels as well as enhance oligomerization of     these proteins. The significance of these findings, however, is unknown. This clinical study     seeks to correlate perioperative inflammatory responses, perioperative changes in     amyloid-beta protein levels (markers of AD) with neurocognitive and functional outcome in the     elderly who are at risk for POCD. This knowledge does not exist, but is essential in the     effort to plan perioperative care that can reduce the incidence of POCD as well as improve     functional recovery.   "
228968|NCT00851266|"     This is a first in man study evaluating the tolerability and immunogenicity of BIPCV/IMX     (V512) at increasing concentrations of influenza viral peptides A/M2+B/HA0 peptides and IMX,     a saponin-based adjuvant.   "
228946|NCT00850954|"     Objectives:      Exposure to secondhand smoke (SHS) is a major public health problem in the United States.     Studies conducted in this country and internationally have irrefutably shown the causal role     of passively inhaled cigarette smoke in development and exacerbation of acute and chronic     diseases.      The intervention will be delivered primarily in the form of fotonovelas based on smoking     cessation programs previously developed, and the national telephone quit line specifically     designed to serve Latino users. The intervention addresses the needs of Mexican American     families (youth, middle-aged, and older adults). The evaluation study will be a randomized,     controlled trial with assessments at baseline and at 6 and 12 months post-treatment. Up to     125 households will be recruited from the established cohort of Mexican American households     located in the Houston metropolitan area.      The objectives for this study are as follows:      1. Reduction in secondhand smoke exposure: The study will distinguish if a tailored     intervention designed to address the needs of the target group will reduce objectively and     subjectively measured secondhand smoke exposure of nonsmokers in MA households.      1a. Develop tailored Fotonovelas for intervention implementation      2. Smoking cessation: The study will identify if a tailored intervention designed to address     the needs of the target group will help the primary smokers in the household quit smoking.      3. Stages of change: The study will identify if the proposed intervention will have a     significant impact on the primary smoker(s) progression through the stages of smoking     cessation.      4. Knowledge and attitudes: The study will identify if the proposed intervention will result     in better knowledge and changed attitudes towards secondhand smoke exposure among members of     MA households (smokers and nonsmokers) compared to standard care.      5. Perceived health: The study will distinguish whether reduced exposure to secondhand smoke     would improve perceived health.   "
228947|NCT00850980|"     The study will enroll patients that are already in AF and in which open-heart surgical     intervention has been scheduled. In these patients AVN-VNS will be delivered briefly     (minutes) after the incision as a proof-of-concept therapy, with concomitant monitoring of     the effects on the ventricular rate.   "
228948|NCT00850993|"     The purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and     effective in the treatment of hyperbilirubinemia in hemolyzing neonates.   "
228949|NCT00851006|"     The purpose of this study is to see if creatine, which is a naturally occurring chemical in     the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers.     Creatine may have effects of interest in the brain. The reason for the MRI component of this     study is to learn about new ways to see inside the brain. The investigators will use magnetic     fields and radio waves to look at the brain and chemicals in the brain. The investigators     hope that this technique will have medial use in the future.      The primary hypothesis of the study is that oral creatine supplementation will have a     beneficial effect as adjunctive therapy in female adolescents with MDD who are non-responders     to an adequate trial of the SSRIs Fluoxetine or Escitalopram.   "
228951|NCT00851032|"     Primary Objective The primary objective of this study is to establish a program for the     molecular profiling of patients with advanced cancer, with the goals of (1) providing a     comprehensive characterization of the molecular profiles of individual patients and (2)     correlating molecular profile with response to phase I therapies.      Specimens will be received from the LAB07-0817 (Tissue Bank) protocol in the Department of     Investigational Cancer Therapeutics. Note that this study is considered an umbrella protocol     to systematically enroll phase I patients for molecular profiling analysis and correlate the     results with treatment outcomes. The IMPACT trial is not a treatment protocol.      Secondary Objectives        1. To characterize advanced cancer by delineating genetic mutations, amplifications,          translocations, and other defining molecular patient characteristics.        2. To assess the antitumor effects of treatments by tumor responses using the World Health          Organization (WHO) or Response Evaluation Criteria in Solid Tumors (RECIST) criteria          and/or any other clinical benefits, including progression-free survival and overall          survival, demonstrated in phase I clinical trials.        3. To correlate molecular profiles of patients with evidence of antitumor activity          (complete remission, partial remission, prolonged stable disease, or overall survival)          to define subsets of patients who will respond to specific therapies in clinical trials          of novel agents.        4. To correlate molecular profiles with toxicities induced by investigational agents to          define subsets of patients who may or may not be candidates for treatment with these          agents in the future.   "
228952|NCT00851045|"     The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab,     both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of     subject with metastatic colorectal cancer   "
228953|NCT00851058|"     To determine the effectiveness of four group session of motivational counseling plus six     hours of direct observations of the emergency department trauma services in comparison to     four group session and six hours of community volunteering and also in comparison to four     hours of education and 16 hours of community volunteering in reducing alcohol use and high     risk driving behaviors and offenses among court referred 16-20 year old drivers.   "
228954|NCT00851071|"     This study will compare the effectiveness that Cognitive Behavioral Therapy has on decreasing     the amount of anxiety, as well as the number of inappropriate firings that a patient with an     ICD may experience.   "
228955|NCT00851084|"     The primary objective of the study is to estimate the progression-free survival rate at 12     months for the two arms of the study.      Secondary objectives include the evaluation of overall objective response rate to treatment,     progression-free survival, overall survival, safety and documentation of potential     immunogenicity of aflibercept.      This study was a non-comparative randomized trial and was not powered for a comparison of any     of the efficacy endpoints.      Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and     safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of     non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a     check on the similarity of the current patients to the historical controls with respect to     clinical outcome when given FOLFOX6 treatment.   "
228969|NCT00851279|"     This is a prospective, non-randomized, multi-center clinical case series evaluating the     outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases. Subjects     will be evaluated acutely and will be followed clinically at 1, 6 and 12 months     post-treatment.   "
228970|NCT00851292|"     The purpose of this study is to study the difference in prostate cancer between two prostate     biopsy techniques, namely end-firing and side-firing. These differ in the angle at which the     prostate is biopsied.   "
228971|NCT00851305|"     The purpose of this study is to determine whether endomicroscopy can improve the detection of     Early Gastric Cancers (EGC).   "
228956|NCT00851110|"     Objectives of the study:      This randomized multicenter phase II study compares the tolerability, toxicity and quality of     life between two high-dose chemotherapy regimens based on cyclophosphamide, thiotepa and     carboplatin.      Regimen A: full dose CTC. Regimen B: two courses of CTC (tCTC) with 33% dose reduction.      Primary endpoints are:        -  Maximum degree of non-hematological toxicity.      Secondary endpoint:        -  Total number of hospital days.        -  Quality of life evaluations during and following high-dose chemotherapy (up to 1 year).        -  Effect of therapeutic dose monitoring of CTC or tCTC.      Trial design:      This investigation is a multicenter prospective randomized phase II study. Patients eligible     for the study will be identified after mastectomy or wide tumor excision with axillary     clearance. Following randomization, all patients will receive four courses of     cyclophosphamide, epirubicin and fluorouracil (FEC). Patients with early progressive disease     at any time will be taken off study. The first chemotherapy course must be given as soon as     possible after the surgical procedure, preferably within 3 weeks, but not later than 6 weeks     since primary surgery. After the third or fourth FEC course G-CSF is administered and     peripheral stem cells will be harvested. All radiation therapy (including radiation therapy     administered as part of a breast conserving strategy) must be postponed until all     chemotherapy has been concluded.      Questionnaires, comprising the Rotterdam Symptom Checklist (RSCL) and the Short-Form General     Health Survey (SF-36) will be sent by mail before randomization, after chemotherapy, 3 months     thereafter, further on every l/2 yr till at least 1 year follow-up as performed earlier. [6,     28, 29].      All patients will be randomized before the initiation of chemotherapy.        -  The 'standard' treatment arm will include 4 courses of FEC followed by high-dose          chemotherapy with a single course of full dose CTC followed by peripheral stem cell          reinfusion. Subsequently, conventional external beam radiotherapy to the breast or chest          wall and to the regional lymph node areas including the axilla and the parasternal area          will be administered following guidelines of the individual center. Patients with          hormone receptor positive disease will go on to receive 5 years of tamoxifen. Patients          with receptor positive disease who have not entered menopause will be advised to undergo          ovarian ablation as well.        -  The 'experimental' treatment arm will be identical to the 'standard' one, except that          the single course of CTC will be replaced by 2 courses of tCTC each followed by          peripheral stem cell reinfusion.   "
228957|NCT00851123|"     The purpose of the study is to evaluate the benefit of two different treatment approaches for     the hemiplegic arm, modified Constraint-Induced Movement Therapy and task-related bimanual     training.   "
228958|NCT00851136|"     This will be a multicenter, open-label study enrolling a total of up to 23 patients.   "
228959|NCT00851149|"     The purpose of this study is to investigate the contents in blood sampled from surgery site     during hip replacement compared with blood sampled from abdominal aortic surgery. Is there     any difference in pro-inflammatory cytokines (IL-1beta, IL-6, IL-8 and TNF-α), complement     activation (C3a)?   "
228960|NCT00851162|"     The purpose of this study is to determine whether using mesenchymal stem cells will heal     benign bone lesion defects faster than demineralized bone matrix   "
228988|NCT00851526|"     The COBIS registry is multi-center, real-world registry of drug-eluting stenting in coronary     bifurcation lesions in South Korea.      The aim of the study was to find out the current status of bifurcation drug-eluting stenting     and determine the prognostic factors for long-term outcome in South Korea.   "
228961|NCT00851175|"     Rationale:      Statins form a class of drugs that is widely prescribed for hypercholesterolaemia,     specifically to reduce the risk on atherosclerosis by lowering LDL-cholesterol. Next to the     effect for which the drug was originally developed, it became obvious that statins have     several other beneficial effects. Such pleiotropic effects include the activation of     ecto-5'-nucleotidase which can increase endogenous adenosine production (by dephosphorylation     adenosine monophosphate into adenosine) and subsequently cause vasodilation. A recent study     of Meijer et al (not yet published) showed that rosuvastatin significantly augments     vasodilation after a brief period of ischemia (post occlusive reactive hyperaemia). However,     it is not yet verified whether this increase in post occlusive reactive hyperaemia is truly     caused by a rise of extracellular adenosine and subsequent adenosine receptor stimulation. In     this study, the mechanism by which rosuvastatin augments post occlusive reactive hyperaemia     will be investigated by blocking adenosine receptors with caffeine, a competitive A1 and A2     adenosine receptor antagonist. Caffeine is a substance that can be safely used in normal     concentrations to block the adenosine receptor.      Hypothesis:      The augmenting effect of rosuvastatin on PORH is caused by an increase of extracellular     adenosine formation and this effect can be diminished by blocking the adenosine receptor     using caffeine.      Objective:      To study the influence of caffeine on post occlusive reactive hyperaemia before and after 7     days treatment with rosuvastatin.      Study design:      Open label cross-over design Study population: Healthy volunteers, 18-50 years of age      Intervention:      Eight volunteers will receive a 7 day treatment with rosuvastatin 20 mg daily before and     after rosuvastatin treatment caffeine will be administrated intra-arterially.      Main study parameters/endpoints:      Forearm blood flow (FBF) will be measured as an indicator for post occlusive reactive     hyperaemia (PORH).   "
228962|NCT00851188|"     The current study aims to evaluate the effects of internet-delivered self-help CBT for     insomnia through a randomised controlled trial. Adult persons with insomnia will be invited     via a popular scientific website to fill out online questionnaires. Participants will be     randomised into treatment groups or the waiting list. Participants will be measured 4, 16,     and 40 weeks after intervention with the same questionnaires.   "
228963|NCT00851201|"     The purpose of this study is to address the Healthy People 2010 obesity prevention objective.     This study will test the effects of a comprehensive family weight management program on the     BMI z-score of 7-12 year-old children with a BMI > 85th percentile who receive primary care     in a large municipal Bronx hospital. The intervention framework will draw on social marketing     theory and the transtheoretical model of behavioral change to incorporate successful obesity     prevention strategies. A two-arm randomized controlled clinical trial (RCT), which will     enroll (n =506) 7-12 year old children with a > 85th BMI percentile, will compare the     Experimental Intensive Intervention to a Standard (Control) Intervention. The Standard     Intervention will receive: 1) an initial consult, which includes an overview of lifestyle     goals, 2)quarterly follow-up, 3) and a monthly newsletter. The Intensive Intervention will     add: 1)12 core group modules for parents (to address roles and skills) and for children (to     enhance motivation and skills and to provide physical activity), 3) Tailored support using a     toolbox approach from community health workers as extensions of the Family Weight     Management professional education staff, and 4) monthly after-core follow-up groups. The     study will determine if children randomized to the Experimental Intensive Intervention will     have greater improvement in BMI change (z-scores) than those randomized to the Control     Standard Intervention. The study will also evaluate the effects on the Experimental     Intervention on lifestyle variables and assess intervention costs. The RE-AIM evaluation will     address: Reach: How many of the eligible children/ families were referred and how many of     those referred actually enrolled? We will use BMI data in the computerized medical records to     evaluate the proportion and the appropriateness of the referrals. Efficacy/Effectiveness: How     did the Experimental intervention affect BMI (changes in z-score), and key biomarkers when     followed as planned? Adoption: How acceptable were the intervention(s) to the primary care     medical team and the children/families in the pediatric clinics etc? (from process measures     and post intervention surveys) Implementation: How many of the intervention activities were     provided as planned? Quality control measures will be used to evaluate the integrity of the     intervention(s). Maintenance: How much of the intervention effect is sustainable? Individual     effects will be evaluated based on the 24 month follow data. Institutional effects evaluation     will include the potential to maintain services using third-party coverage.   "
228964|NCT00851214|"     This study is an observational prospective pilot trial that utilizes finger cuff non invasive     hemodynamic monitoring (NexfinHD Monitor) to assess 4 different groups (CHF/COPD, Trauma,     Sepsis, Stroke) of patients on arrival to the Emergency Department and to document the     changes seen in these hemodynamics with acute therapies.   "
228965|NCT00851227|"     A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and     moderate liver impairment versus subjects with normal liver function   "
228966|NCT00851240|"     Patients with adult-onset rheumatoid arthritis will be enrolled. They will be dosed with     repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the     treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to     treatment groups will occur at random, and the actual treatment will not be revealed to the     investigator or to the patient during the trial.   "
228967|NCT00851253|"     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and     cause less damage to normal tissue.      PURPOSE: This phase I trial is studying the side effects of stereotactic radiosurgery in     treating patients with locally advanced or recurrent head and neck cancer.   "
228972|NCT00851318|"     The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol as     add-on medication to methotrexate over the long term in Japanese RA patients transferred from     Study 275-08-001 (NCT00791999), and to evaluate the effects of different dosing regimens on     the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20)     responders who completed Study 275-08-001.   "
228973|NCT00851331|"     Epilepsy is a frequent neurological disease in childhood, characterized by recurrent seizures     and sometimes with major effects on social, behavioral and cognitive development. Childhood     focal epilepsies particularly are age-related diseases mainly occurring during developmental     critical period. A complex interplay between brain development and maturation processes and     susceptibility genes may contribute to the development of various childhood epileptic     syndromes associated with language and cognitive deficits. Indeed, the Landau-Kleffner     syndrome (LKS), the continuous spike-and-waves during sleep syndrome (CSWS), and the benign     childhood epilepsy with centrotemporal spikes (BCECTS) or benign rolandic epilepsy, are     different syndromes that are considered as part of a single continuous spectrum of disorders.     While genetic component in those three syndromes remains elusive, novel and high throughput     genome analyzes could bring interesting insights into the possible genetic defects and     pathophysiological mechanisms underlying and linking the various disorders associating     epilepsy with speech and cognitive impairments.   "
228974|NCT00851344|"     A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of     single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the     efficacy and safety using an Environmental challenge chamber in male subjects with seasonal     allergic rhinitis   "
228975|NCT00851357|"     The primary purpose of this study is to determine the effects of distributing free nicotine     replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims     to:        1. Test if sending active nicotine patches directly will lead to a higher quit rate,          compared to a condition where the quitline assists the smokers to obtain patches by          other means (e.g. via their health plans).        2. Test if sending placebo patches directly will also lead to a higher quit rate.        3. Test if quitline counseling increases the quit rate when the smokers already receive the          nicotine patches.   "
228976|NCT00851370|"     The objective is to conduct an exploratory study on the effect of Omalizumab on COPD patients     with elevated IgE. Exploratory outcomes include to determine whether Omalizumab use: reduces     exacerbations in COPD patients; or improves rescue medication use, decreases ICS use,     modified Medical Research Council (MMRC) dyspnea score, St. George's Respiratory     Questionnaire (SGRQ), 6-minute walk distance (6MWD), forced expiratory volume at one second     (FEV1)(the latter 3 with BMI make up the BODE score), residual volume (RV), total lung     capacity (TLC), exhaled nitric oxide (ENO), and determination C-reactive protein (CRP).   "
228977|NCT00851383|"     The purpose of this study is to evaluate the safety and immunogenicity of Ad35-GRIN/ENV HIV     vaccine and Ad35-GRIN HIV vaccine administered intramuscularly at 0 and 6 months.   "
228978|NCT00851396|"     The purpose of the study is to assess the relationship between vitamin D status and insulin-     glucose dynamics in obese Adolescents. The study is intended to assess the difference in the     insulin sensitivity before and after correction of vitamin D deficiency.   "
228979|NCT00851409|"     Hereditary angioedema (HAE) is a disease characterized by recurrent tissue swelling     affecting various body locations. Recent literature shows that patients with frequent attacks     may benefit from long-term prophylaxis. This study aims to evaluate the safety and     prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor     (rhC1INH).   "
228980|NCT00851422|"     Accurate cardiac output determination is a commonly used and important index of myocardial     performance. The thermodilution method using a pulmonary artery catheter is the most common     approach to cardiac output determination; however, placement of the pulmonary artery catheter     is not without risk and at times can be problematic. Ultrasound dilution measurement has been     shown to correlate with measured cardiac output in animal models and adults, but it has not     been validated in pediatric patients. This study will validate the accuracy of ultrasound     dilution measurements of cardiac output to thermodilution measurements of cardiac output in     pediatric patients.   "
228981|NCT00851435|"     The objectives of this open study are to assess the safety, tolerability, pharmacokinetics     and clinical outcome of patients who have HAP caused by Pseudomonas aeruginosa serotype O11     after three separate administrations of KBPA-101 every third day in addition of standard of     care antibiotic treatment.   "
228982|NCT00851448|"     To test the compliance, tolerance, safety and to get preliminary insights into the efficacy     of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and     antioxidants) designed to prevent or delay cachexia and anorexia in lung cancer patients.   "
228983|NCT00851461|"     This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has     benefit in SBMA      Objective:        1. To study effects of Goserelin to clinical course of patients with spinal and bulbar          muscular atrophy in Thailand        2. To demonstrate physiological and pathological changes in treated patients with          Goserelin.        3. To assess tolerability and adverse effect of Goserelin therapy   "
228984|NCT00851474|"     Cardiac Output (amount of blood pumped by the heart in one minute) will be measured using the     new COstatus(R) system and these values will be compared with cardiac output values measured     by other methods such as thermodilution. Blood volumes measured by the COstatus(R) system     will also be recorded.   "
228996|NCT00851630|"     The purpose of this study is twofold: (1) to assess the feasibility and safety of fixed dose     combination zidovudine/lamivudine/abacavir in HIV infected subjects with tuberculosis in a     resource-limited setting, and (2) to assess the impact of delayed versus early initiation     strategies for fixed dose combination zidovudine/lamivudine/abacavir on the rate of     tuberculosis-associated immune reconstitution inflammatory syndromes.   "
228997|NCT00851643|"     This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV)     L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS)     and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s)     of IMX for further studies of the octavalent HPV L1 VLP vaccine.   "
228985|NCT00851487|"     Many children with non-severe pneumonia (cough and fast breathing) have neither clinical     pneumonia as assessed by physicians nor pneumonia on chest radiographs. Inappropriate use of     antibiotics for these cases is leading to resistant strains of bacteria in the community.     Evidence shows that almost 50% of antibiotic prescription is unnecessary.As over half of     antibiotic prescription for ARI are not necessary since most of these infections are viral     and do not respond to antibiotic therapy which will be source of resistance in the community.      To address this issue the investigators conducted this randomized, double blind placebo     controlled clinical trial of oral Amoxicillin versus placebo in children with non-severe     pneumonia taking into account all the necessary safety precautions for their well being.      The study hypothesis was that the clinical outcome of children 2 to 59 months of age with     cough and fast breathing (WHO defined non-severe pneumonia) with or without wheezing is     equivalent, whether they are treated with amoxicillin or placebo.   "
228986|NCT00851500|"     The purpose of this study is to evaluate the safety and efficacy of K-604 for the treatment     of atherosclerosis.   "
228987|NCT00851513|"     Pudendal neuralgia is a recent identified pathology, extremely invalidating, related to     chronic pelvic entrapment. Nowadays, pudendal neuralgia can be treated with:        -  neuropathic pains treatment        -  specific kinesitherapy        -  Alcock's canal and sacrospinal ligament infiltrations under scan        -  with diagnostic block        -  local steroids injections        -  and surgical decompression of pudendal nerve with transrectal approach.      Only surgery was validated after a randomised protocol studying surgery versus abstention,     performed and published by the CHU de Nantes. Many techniques have been proposed for     realization of pudendal nerve infiltrations. The results of these infiltrations have never     been published, and no randomised study had ever evaluated those results, even at short-run.     Very few randomized studies have validated steroids infiltrations techniques in canal     syndrome neuropathies.      The primary objective of the investigators phase IV trial is to evaluate the efficacy of     three different types of pudendal nerve infiltrations in Alcock's canal and sacrospinal     ligament:        -  group A: only local anesthetic (control arm)        -  group B: local anesthetics associated with local steroids        -  group C: local anesthetics associated with local steroids and important volumes of          physiological serum   "
230808|NCT00867724|"     A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling     through the colon in low risk subjects.   "
228990|NCT00851552|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy,     such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or     carry cell-killing substances to them. Giving bortezomib together with doxorubicin     hydrochloride liposome and rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin     hydrochloride liposome and rituximab works in treating patients with diffuse large B-Cell     lymphoma that has relapsed or not responded to treatment.   "
228991|NCT00851565|"     To compare treatment outcome in patients with Crohn's disease with secondary loss of response     to infliximab (i.e. initial good response follow by loss of response) treated according to     current standards based only on clinical features versus treatment based on serum levels of     infliximab and anti-infliximab antibody (Ab) status.   "
228992|NCT00851578|"     The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure     Device in atrial fibrillation patients for which long term warfarin therapy is     contraindicated.   "
228993|NCT00851591|"     Each year, approximately 3 million mothers in the USA alone leave the hospital breastfeeding     an infant. However, a large number discontinue breastfeeding, because milk synthesis is poor     or simply stops. Termed Insufficient Milk Syndrome, this condition probably accounts for     approximately 5-10% of the total population of breastfeeding mothers and includes many     mothers with premature infants, mothers with polycystic ovary syndrome, and a myriad of other     unknown causes. The mother's inability to breastfeed causes enormous feelings of inadequacy,     grief, depression, and other problems, not to mention increased health risks to the infant.      The most popular herbal remedy used around the world for increasing milk synthesis is     fenugreek. Fenugreek (Trigonella foenum graecum) is a seed product from the legume family     that is commonly sold, since the dried, ripe seed and extracts are used as an artificial     flavor for maple syrup. When used orally in amounts commonly found in foods, it has been     granted Generally Recognized as Safe (GRAS) status in the USA by the FDA. Although it is used     by millions of women around the world to increase their milk supply, we have only one small     case report which suggested it might actually increase the milk supply.      In this one study, the authors found an approximate 40% increase in milk production, although     the study was not blinded, nor did they use a control population. For these reasons, we still     do not know with certainty if fenugreek works as a galactagogue.      This study is designed to accurately determine if seven days of fenugreek will stimulate milk     production in a selected group of subjects with poor milk supply. We hypothesize that the     women enrolled in the test group will have increased milk production at the end of the 8-day     study.   "
228994|NCT00851604|"     The purpose of this study is to determine whether monitoring of levels of Serological Markers     ProGRP, CgA, NSE and Pyruvate Kinase M2 are effective in the Evaluation of Diagnosis,     Monitoring Therapeutic Effects and Predicting response to somatostatin analogues in Patients     with Malignant Neuroendocrine Tumors.   "
228995|NCT00851617|"     Patients under threshold IMT show better conditions to weaning from mechanical ventilation     than the control group.   "
228998|NCT00851656|"     The purpose of this study is to evaluate the performance of the UpSpring Milkscreen Test for     Alcohol in Breast Milk to detect alcohol in breast milk from lactating women.   "
228999|NCT00851669|"     The aim of this study is to evaluate an interpersonally-focused intervention (Interpersonal     Psychotherapy) for women with co-occurring alcohol dependence and depression. A sub-protocol     has been added to pilot the current study with men with co-occurring alcohol dependence and     depression.   "
229000|NCT00851682|"     The purpose of the present study is to find out if MRI techniques examining (1) the motion of     water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow     to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition     of the prostate (MR spectroscopy), can be used to detect prostate cancer early and     non-invasively. Localization of the cancer within the prostate would be of particular     importance in focal cryoablation of prostate carcinoma which we hope to improve as a result     of this project.      Additional aim of the study is to correlate expression of genes believed to pay a role in     prostate cancer with MRI findings.   "
229001|NCT00851695|"     Asthma and chronic obstructive pulmonary disease (COPD) are diseases that affect a person's     ability to breathe normally. People who do not receive enough vitamin D may have a higher     risk of developing asthma or COPD. This study will examine previously collected blood samples     of participants in three studies to determine whether people with low vitamin D levels have     an increased risk of severe asthma or COPD.   "
229002|NCT00851708|"     The aim of this interventional, prospective, randomized clinical trial is to evaluate the     impact of the antioxidant N-acetylcysteine on oxidative stress in the first seven     postoperative days and on renal function in the first three postoperative months in deceased     kidney transplantation.   "
229003|NCT00851721|"     The purpose of the study was to determine the efficacy, safety, and health-related quality of     life benefits with FEIBA NF prophylactic treatment as compared with on-demand treatment.   "
229004|NCT00851734|"     This is a first-in-man study for the purpose of determining the safety and tolerability of     LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.   "
229005|NCT00851747|"     The primary objective of this study is to determine the efficacy of phosphatidylcholine and     deoxycholate subcutaneous injections for localized fat removal.      Subcutaneous injections of the study drug will be efficacious in decreasing localized fat     deposits due to the known fat necrosis effects on fat tissue after study drug tissue     incubation.   "
229006|NCT00851760|"     The investigators proposed to assess the functional and anatomical outcomes of cataract and     idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.   "
229007|NCT00851773|"     This trial is conducted in Europe. The aim of this clinical trial is to assess and compare     the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses     of NN9535 in healthy male Japanese and Caucasian subjects.   "
229008|NCT00851786|"     Herpes zoster, or shingles, is the result of a viral infection that causes a painful skin     rash, usually in older people or people with suppressed immune systems like those infected     with HIV. The ZOSTAVAX vaccine has been shown to reduce the number of infections and symptoms     of herpes zoster infection in people over the age of 60. The purpose of this study is to     evaluate the safety, tolerability, and immunogenicity of two doses of ZOSTAVAX in     HIV-1-infected adults with conserved immune function (Cd4+ T cell counts >=200 cells/uL)     virologically suppressed on potent combination antiretroviral therapy (ART).   "
229009|NCT00851799|"     The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV-infected     people who have never received anti-HIV therapy be treated with a triple drug regimen     (commonly called combination antiretroviral therapy, cART). Since the introduction of cART,     morbidity and mortality among HIV-infected patients has been dramatically reduced. However,     metabolic, skeletal, and cardiovascular diseases have been increasingly reported among     HIV-infected patients and may be attributable, in part, to the direct effects of cART. Much     of our understanding of the development of these diseases, risk factors, and consequences of     these disorders has been derived from clinical studies of HIV-infected persons receiving     older antiretroviral agents.      A5260s was designed to examine the contributions of HIV-disease related factors and impact of     newer antiretroviral drugs on the development of metabolic (such as blood vessels, blood     sugar, cholesterol), skeletal, and cardiovascular diseases in people who have never received     anti-HIV therapy. A5260s is a prospective substudy of a phase III randomized clinical trial     A5257 (see ClinicalTrials.gov identifier: NCT00811954). A5257 was designed to look at     different combinations of anti-HIV drugs that do not contain the medication efavirenz (EFV)     and how well these drug combinations work to decrease the amount of HIV in the blood and to     allow immune system recovery in people who have never received anti-HIV therapy. A5257 also     examined drug tolerability and safety for the various drug combinations.   "
229010|NCT00851812|"     The purpose of this study is to examine if exercise helps improve cancer-related fatigue.      Hypothesis: A structured home-based walking and progressive resistance exercise program will     be efficacious in relieving cancer-related fatigue, preventing aerobic and anaerobic     deconditioning and skeletal muscle wasting, as well as improving inflammatory cytokine     profiles in breast cancer survivors as well as those receiving radiation treatment.   "
229011|NCT00851825|"     The discontinuation of mechanical ventilation (MV) and the recovery of spontaneous breathing     can lead to important cardiovascular alterations due to changes in the intrathoracic     pressure. The autonomic modulation assessed through heart rate variability (HRV) during     weaning from MV and its impact on cardiorespiratory variables has not been well elucidated     yet. To evaluate the effect of T-tube (TT) and pressure support ventilation (PSV) during     weaning from MV on cardiorespiratory variables and heart rate variability.   "
229012|NCT00851838|"     A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing     strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is     to evaluate the possibility to formulate PD solutions containing L-carnitine as an osmotic     agent to partially replace glucose.   "
229013|NCT00851851|"     Measuring novel proteins in the urine of surgical patients that can be used to diagnose     impending acute or chronic renal failure.   "
229014|NCT00851864|"     The purpose of this study is to evaluate the safety and efficacy of therapeutic     anticoagulation with tinzaparin during pregnancy via weight-based dosing.   "
229043|NCT00838916|"     A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.   "
229015|NCT00851877|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation and cisplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances     to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel     albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation     therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation     together with cisplatin and cetuximab may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel     albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab,     and radiation therapy to see how well they work in treating patients with locally advanced     stage III or stage IV head and neck cancer.   "
229016|NCT00851890|"     The purpose of this study was to assess the safety, tolerability, pharmacokinetics and     antiviral activity of ABT-333 (also known as dasabuvir) in treatment-naïve, hepatitis C virus     (HCV)-infected participants.   "
229017|NCT00851903|"     This study was the extension of the LANTU_C_02761 study named EASIE and identified as     NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve     patients treated with metformin and not adequately controlled).      All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had     the possibility to enter this extension study if they met the other inclusion criteria and     did not present with any exclusion criteria.      The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension     study which consisted of a 12-week treatment period.      The objectives of this extension study were:        -  To assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with          metformin, insulin glargine and sitagliptin in patients not adequately controlled by a          previous treatment with metformin plus either insulin glargine or sitagliptin.        -  To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level,          fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight          and overall safety.   "
229057|NCT00839098|"     The purpose of this randomized control study is to evaluate the use of electric powered     wheelchairs and powered seating function patterns of Veterans to determine how usage patterns     relate to activity, participation, and seating discomfort. In addition, it will be determined     if a training program or a training program with a virtual coach will improve compliance of     clinical practice guidelines for pressure relief, upper limb preservation, and discomfort     management. The virtual coach is a portable, programmable intelligent reminder designed to     enhance a person's use of their power wheelchair and power seat functions.   "
229018|NCT00851916|"     The purpose of this study is to scientifically evaluate the effects (good and bad) of a new     type of radiation treatment in patients with locally recurrent prostate cancer after prior     radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from     traditional radiotherapy by the application of smaller, more precisely controlled margins     around the area targeted for full dose radiation, and far fewer treatments, using a much     larger dose per treatment.      This research is being done to see what advantages, if any, prostate radiosurgery may have     over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity     focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.   "
229019|NCT00851929|"     Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension     in patients with Sarcoidosis   "
229020|NCT00851942|"     Synacthen® is a synthetic analogue of ACTH which has been used since the 1960s to assess     adrenal sufficiency. It is now well established as a first line test to investigate diseases     of the hypothalamo-pituitary-adrenal axis and to assess adrenal function in patients on     long-term corticosteroid therapy. Briefly, cortisol is measured before and after injection of     250 micrograms of Synacthen®. In a normal individual serum cortisol will rise to     concentrations greater than an arbitrary value (typically 550 nmol/l) 30 minutes after     administration of Synacthen®.      In 2004 the All Wales Clinical Biochemistry Audit group surveyed protocols for performing and     interpreting short Synacthen® tests. This identified wide differences in practice within     Wales. As a result standards were drawn up for performance of the test. It was noted that     there was considerable variability or bias between cortisol immunoassays and that the     cortisol cut-off chosen for interpretation of the short Synacthen® test should be method     dependent.      Clark et al., in 1998 reported cortisol cut-offs following Synacthen® using 4 well     established commercially available cortisol immunoassays. This study demonstrated     considerable differences between the cortisol immunoassays used in clinical laboratories at     the time. It was also apparent that there were differences in gender-related responses to     Synacthen® although there was no dependence on age. In the 8 years since publication of this     study there have been advances in formulation of cortisol immunoassays as well as the     instrumentation used to perform analyses. At the University Hospital of Wales cortisol is     currently assayed using the Bayer Centaur automated immunoassay analyser. This assay was not     available at the time of the study by Clark et al.,. The investigators' current short     Synacthen® test cut-offs therefore rely on historical reference ranges which have become     outdated. A re-evaluation of the cortisol cut-off is required to ensure that patients are not     incorrectly classified.      It has been long been recognised that oestrogens (including ethinyloestradiol prescribed in     combined oral contraceptive pills) increase total (but not free) serum cortisol levels. The     degree of increase is related to the dose used and is thought to be due to an elevation in     cortisol binding globulin (CBG). However, no comparisons of total serum cortisol in response     to Synacthen® have been performed between women taking oestrogens and those who are not.     Knowledge of the salivary cortisol response may also be useful in patients with decreased     serum CBG concentrations e.g. severe nephrotic syndrome in whom the serum cortisol response     may be misleading. The investigators therefore plan to measure salivary cortisol as part of     the investigators' study protocol to assess the response of free cortisol.      17 Hydroxyprogesterone (17OHP) is an intermediate in the biosynthesis of cortisol. Deficiency     of 21-hydroxylase enzyme activity leads to an increased concentration of 17OHP in the     peripheral circulation. The short Synacthen® test can be used to assist in diagnosis of mild     cases of congenital adrenal hyperplasia. Current reference ranges are taken from the     literature.   "
229021|NCT00851955|"     The investigators hypothesize that the CXCR2 ligands/CXCR2 biological axis plays an important     role in promoting angiogenesis in PC; and that the genetic changes and the microenvironment     of the tumor regulate the expression of CXCR2 ligands/CXCR2 in PC in order to potentiate     their angiogenic phenotype. A corollary of this hypothesis is that the cell surface receptors     (CXCR2) and the intracellular signaling pathways that mediate the angiogenic responses     induced by ELR+ CXC-chemokines are potential targets for novel therapeutic interventions in     PC.   "
229022|NCT00851968|"     Intraoperative bleeding remains a major concern during liver resection. Pringle maneuver is     the most frequently used method to occlude inflow blood of the liver.However, experimental     and clinical studies have shown than even short periods of clamping produce some degree of     ischemia-reperfusion injury that can result in hepatocellular damage,this damage being     especially important in patients with abnormal liver parenchyma such as steatosis and     cirrhosis. The aim of this study was to evaluate whether the use of selective vascular     clamping should be generalized to HCC patients and help to reduce the ischemia-reperfusion     injury.   "
229023|NCT00851981|"     Background: Alcoholic liver disease is one of the most important causes of chronic liver     disease in this country. There is currently no treatment for chronic alcoholic liver disease     other than abstinence. Hepatic methionine metabolism is abnormal in these patients and one of     the consequences is depletion of S-adenosylmethionine (SAMe) levels, which can affect     numerous important cellular processes. SAMe has been increasingly utilized for the treatment     of liver diseases although the protective mechanisms remain unclear. A recent randomized     double-blind trial using SAMe in patients with alcoholic liver disease and found improvement     in 2-year survival in those with less advanced liver disease. However, important changes in     methionine metabolism and histological changes were not included in the study. Aim: The goal     of this study is to determine the effect of SAMe administration on key metabolic     abnormalities of the methionine cycle and on the recovery from alcoholic liver disease.   "
229024|NCT00851994|"     The investigators are measuring novel proteins in the urine of patients having surgery.   "
229025|NCT00838669|"     The purposes of this study are to evaluate the effect of food on the pharmacokinetics of     extended-release (ER) OROS paliperidone in healthy men, and to evaluate the effect of posture     on the pharmacokinetics of ER OROS paliperidone under fasting conditions. Additionally, the     safety and tolerability of the treatments in healthy men will be assessed.   "
229026|NCT00838682|"     This study is conducted to compare and evaluate the effect of administering a high-dose     intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent     bleeding after the endoscopic treatment of bleeding peptic ulcers.   "
229027|NCT00838695|"     The goal of this project is to determine the genetic factors contributing to interindividual     differences in response to physiological and pharmacological vasoconstrictors and     vasodilators.   "
229028|NCT00838708|"     Pruritus is an essential feature for the diagnosis of atopic dermatitis and may play an     important part in disease progression. Itching has a significant impact on the quality of     life of AD sufferers, in particular night-time itching leading to sleep disturbance and     subsequent poor daytime performance.      The objective of this study is to determine whether SRD174 Cream is a safe and effective     therapy for moderate to severe pruritus associated with atopic dermatitis.   "
229029|NCT00838721|"     Laser Trabeculoplasty has been shown to be effective in lowering intraocular pressure (IOP)     in patients with primary open-angle glaucoma (POAG). Although initially demonstrated with the     Argon laser (ALT), several other laser systems have also been employed with comparable     efficacy. Recently, Selective Laser Trabeculoplasty (SLT) has been shown to lower intraocular     pressure comparable to ALT. The advantage of SLT is that the target eye structure, the     trabecular meshwork, remains intact with minimal damage at the cellular level. In contrast,     ALT lowers IOP at the expense of scarring of the trabecular meshwork. The purpose of this     study is to evaluate the efficacy of lowering IOP with Pascal Laser Trabeculoplasty (PLT)     employing reduced energy levels compared to ALT and a computer guided pattern of laser     treatment applications.   "
229030|NCT00838734|"     In this study, the investigators employed Visante-OCT (Carl Zeiss, USA), an anterior chamber     optical coherence tomography, to monitor the change of anterior chamber dimensions. These     data were correlated to anterior and posterior curvature changes collected with the Oculus     Pentacam (Oculus Inc., Germany), a corneal topographer based on rotating Scheimpflug     principle. To minimize the effect of convergence and excyclotorsion during examination,     topical cycloplegic medication was used. The investigators hypothesized that if there is a     link between ciliary muscle contraction and cornea curvature, installation of cycloplegic     should result in widening of anterior chamber angle to angle distance and flattening of the     cornea curvature data.   "
229031|NCT00838747|"     The folate receptor (FR) is a cell marker that is over expressed on the cell surface of     certain cancers, this occurs most frequently in ovarian cancers. Some normal tissues also     express the FR, however in these normal tissues the FR is usually located on the tissue     surface that is inaccessible to circulating drugs. As such, drugs which target the FR may     potentially be used to achieve anti-tumour efficacy whilst reducing toxicity to normal     tissues. Therefore the ability to measure FR levels from different cancer types may help to     select patients who are most likely to benefit from treatment with FR targeted therapies. One     such drug BGC 945 is currently being tested in preclinical study at The Institute of Cancer     Research   "
229032|NCT00838760|"     The purpose of the study is to determine the safety, tolerability and plasma pharmacokinetics     (pk) (i.e., the levels of TMC558445 circulating in your blood over time) of increasing single     oral doses of TMC558445 and of multiple increasing oral doses followed by a single dose of     TMC310911 to assess the potential boosting effect on the latter compound. In this study, two     investigational new drugs are involved, TMC558445 and TMC310911.      The study has been amended as follows:      TMC558445 will be administered either twice a day (b.i.d.) or once daily (q.d.). A single 300     mg or 600 mg dose of TMC310911 will be administered under fasted or fed conditions. The     boosting effect on Darunavir will be investigated.   "
229033|NCT00838773|"     This grant involves 24 social networks of young men who have sex with men, Roma, and young     high-risk heterosexual adult men and women living in Hungary, Bulgaria and Russia.   "
229034|NCT00838799|"     This study is designed to evaluate the safety and efficacy of RGH-896 in patients with     diabetic peripheral neuropathic pain.   "
229035|NCT00838812|"     The purpose of this study is to determine the safety and efficacy of association between     tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate.   "
229036|NCT00838825|"     The purpose of this study is to compare health care delivery outcomes and costs achieved by     two different approaches to health care delivery. The investigators will compare health     outcomes for groups of adult patents with diabetes. One group will be managed by our     traditional approach to diabetes care. The second group's care delivery is structured     according to a design consistent with the Chronic Care Model (CCM).   "
229037|NCT00838838|"     Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to     decreased bone mineral density resp osteoporosis. In this study bone mineral density is     assessed in hypogonadal paraplegic patients, who are on standard prophylactic therapy for     osteoporosis and and on a standard physiotherapy exercise program one group receiving Nebido     for testosterone replacement (TRT). The additional effect of TRT on bone mineral density /     osteoporosis is assessed (CT scan lumbar spine).   "
229038|NCT00838851|"     The purpose of this study is to determine the range of neutrophil response (influx of PMNs to     the airways as determined in sputum) after inhalation of CCRE (20,000 EU).   "
229039|NCT00838864|"     Prophylactic antibiotics have been routinely recommended for cirrhotic patients with upper     gastrointestinal bleeding recently. However, the regimen and duration of its use remain an     inconclusive issue. Quinolones and 3rd generation cephalosporins have been more often used     for prophyalxis recently. The duration for antibiotic usage were variable in the literatures,     ranged from 4-10 days. The latest guideline from AASLD in 2007 was 7 days. In the survey of     infections in cirrhotic patients with UGI bleeding performed by Bernard et al, most     infections occurred in the first 5 days and half within the first 48 hours. Therefore,     considering the cost-effectiveness and drug resistance issues, the necessity for such     prophylaxis for 7 days may need to be re-evaluated.      The purpose of our study is to investigate the antibiotic prophylaxis duration for cirrhotic     patients with acute gastro-esophageal variceal bleeding. We will enroll those patients     suffering from variceal bleeding documented by endoscopic examination and without apparent     evidence of infection. Those who have received antibiotics within 2 weeks, are less than 18     years old, get pregnant, have malignancy other than HCC, have allergy to ceftrioxone are     excluded. After receiving well explanation and giving consent, these patients are randomly     allocated to 2 groups and receive prophylactic antibiotic just after endoscopic examination;     Group I: receiving ceftriaxone 500 mg iv bolus stat and then q12h for 3 days, Group II:     receiving ceftriaxone 500 mg iv bolus stat and then q12h for 7 days. They will receive     appropriate endoscopic treatment for gastro-esophgeal varices and glypressin 1mg q6h for 3     days. They will start to feed on the 2nd day if not contraindicated. The 2nd endoscopic     treatment for varices will be performed 2 weeks later. We record the demographic data, vital     signs, transfusion amount; check hemogram, U/A, CXR, ascites routine (with apparent ascites),     classification of variceal size and Child-Pugh classification. We monitor the events of     rebleeding & infection, transfusion amount and hospitalization days We use rebleeding rate     within 14 days as the primary end point. It is defined as the following events after initial     stabilization of vital signs for 24 hours; (1): recurrence of hematemesis or bloody stool     (2); need of transfusion more than 2 unit of blood and systolic pressure < 100 mmHg or pulse     rate > 100/mn. We use infection rate during admission and mortality rate within 28 days as     secondary end points.   "
229040|NCT00838877|"     The study is carried out in order to investigate if [18F]AZD4694, compared to [11C]AZD2184,     is a suitable PET ligand for in vivo imaging of Aβ amyloid depositions in the human brain. In     the study the two PET ligands will be examined in both healthy volunteers and patients with     Alzheimer's Disease. A whole body dosimetry scanning will be performed in 6 healthy     volunteers to obtain human data to estimate a safe dose.   "
229041|NCT00838890|"     To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects     with Refractory Hematologic Cancer   "
229042|NCT00838903|"     The purpose of this study is to determine if albiglutide is safe and effective in the     treatment of type 2 diabetes.   "
229044|NCT00838929|"     Vorinostat in combination with radiation therapy can be administered safely and will be     tolerated in patients with brain metastases, while providing an assessment of the anti-tumor     activity of this combination.      This is a multi-center, open-label, non-randomized Phase I study in patients with brain     metastases. Patients will be administered oral Vorinostat and radiation therapy and will be     treated for 3 weeks. Patients will be enrolled in cohorts and will be treated at sequentially     rising dose levels of Vorinostat combined with radiation therapy. We will initially enter 3     subjects at each dose. If none of the three experiences a dose-limiting toxicity we will     proceed to the next dose. If one of the three experiences that level of toxicity, we will     accrue 3 more subjects at that dose. If at any time there are two or more dose-limiting     toxicities (in the 3-6 subjects) on a given dose, we will drop down to a lower dose. Dose     escalation will continue until the MTD of Vorinostat and radiation therapy is established.     The MTD will then be one dose below the DLT occurring in at least 1 out of 3 subjects (2 out     of 6 patients).   "
229058|NCT00839111|"     The purpose of this study is to evaluate the Progression-Free Survival (PFS) time of     Sorafenib in combination with FOLFIRI regimen used as in the second front treatment in     patients with advanced CRC after failure of oxaliplatin treatment.   "
229059|NCT00839124|"     This will be a single center, open label study comparing baseline characteristics of     recovered sputum cells (collected on screening day) to those of cells recovered 6 hours after     inhalational challenge with 20,000 EU Clinical Center Reference Endotoxin (CCRE, a component     of air pollution)) within each group as well as cross group comparisons between individuals     with allergic asthma (AA's)and normal volunteers (NV's). The primary objective of this study     is to test the hypothesis that persons with allergic asthma will have an increased neutrophil     response to challenge with 20,000 EU CCRE compared to normal volunteers. Secondary objectives     include post CCRE comparison between AA's and NV's with regard to changes in airway cells and     blood as well as changes in mucociliary clearance (MCC) in response to inhalation of 20,000     EU CCRE.   "
229045|NCT00838942|"     The VIVA study is focused on Alzheimer's disease patients with a low vision due to a     bilateral cataract. The aim is to study cataract surgery results on patients' autonomy,     behaviour, and mood. In fact those dement elderly patients suffer from a progressive loss of     superior functions, with loss of autonomy, behaviour and mood degradation, associated with     physical disabilities. The work hypothesis is that a loss of sensorial functions,     particularly visual, is an aggravating factor of NEURO-cognitive troubles and absence of     communication with outside circle. The protocol consists in investigating superior functions,     autonomy, and behaviour troubles of the participating patients, with the help of a series of     neuropsychological tests used one month before and three months after cataract operation on     the eye with the worst vision. Independently of the study, patients must have given an     informed consent to cataract surgery. Their participation lasts 4 months+/- 1 month. The aim     of the study is to evaluate whether the cataract surgery improves patients' behaviour,     autonomy and mood and possibly to show evidence onf drawbacks in of such a practice.The main     objective targets to cataract surgery benefice on patients suffering from both Alzheimer's     disease and impeding cataract, aiming to improve behaviour troubles. The specific objective     is to measure this benefice in correlation with visual acuity improvement.   "
229046|NCT00838955|"     This clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard     treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus     has on Hodgkin Lymphoma. The study will also determine whether Temsirolimus is tolerated in     patients with Hodgkin Lymphoma who have been previously treated with chemotherapy.   "
229047|NCT00838968|"     The purpose of the study is to determine whether interferon-alpha is effective in the     treatment of p48 Positive patients with HCC after curative resection.   "
229048|NCT00838981|"     The purpose of this study is to compare the efficacy of the combined treatment modafinil +     Contingency Management (CM) to either treatment condition alone or to yoked-controls on     cocaine abstinence.      To investigate the role of modafinil-related improvements in memory, impulse control, and     attention in mediating cocaine abstinence.   "
229049|NCT00838994|"     The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment     on residual insomnia in major depressive patients.   "
229050|NCT00839007|"     The primary objective of the study is to assess the safety and tolerability of IV     administration of CD-NP and the dose relationship of CD-NP on improvement of clinical     symptoms and renal function in ADHF patients.   "
229051|NCT00839020|"     50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the     study is a comparison between a minimally invasive and a conventional approach. In both     groups OrthoPilot computer assisted-navigation will be used. Pain intensity as well as     concomitant pain medication are monitored during the first 20 postoperative days and will be     compared for the two groups. Various scores are surveyed.   "
229052|NCT00839033|"     The hypothesis is that a mechanical insufflation-exsufflation (MI-E) is associated with a     decrease in the number of intubations and more rapid clinical improvement in children and     adults with neuromuscular disease who are admitted for an acute respiratory exacerbation.In     this prospective, randomised, multicenter study, 55 patients will be treated with standard     treatment and a MI-E, and 55 patients with standard treatment and standard respiratory     physiotherapy. The primary objective is the reduction of the number of patients requiring     invasive ventilatory support (endotracheal intubation or tracheotomy) in the group treated     with MI-E (MI-E group). The main secondary objectives are a reduction in hospital stay and an     improvement in clinical condition, dyspnea and respiratory muscle function.   "
229053|NCT00839046|"     The burden of childhood asthma is borne disproportionately by children living in poverty and     in urban centers, many of whom are from communities of color and are at greater risk for     environmental exposures. Given the complex interaction of physical and social environmental     factors on childhood asthma, there have been increasing calls for comprehensive efforts using     a community-based participatory research (CBPR) approach. Community Action Against Asthma is     a long standing CBPR partnership in Detroit, Michigan, composed of representatives from     community-based organizations, health and human service agencies, and academia. All members     of the partnership have been actively involved in the development of the CBPR project     proposed here. The specific aims are: 1) to test the efficacy of air filters (AFs) separately     and when combined with air conditioners (ACs) to reduce exposure to particulate matter (PM),     over and above a standard community health worker home visit (standard) intervention; 2) to     test the association between any reduction in PM exposure through the use of AFs separately     and when combined with ACs over and above a standard intervention and health outcomes in     children with asthma; 3) to elucidate the causal pathways by which any intervention-related     improvements in children's asthma-related health status is occurring. One hundred and fifty     households in Detroit, Michigan with at least one child with mild persistent or moderate to     severe persistent asthma will be enrolled to participate in the study. Households will be     randomly assigned to one of three groups: a standard household intervention (or control)     group; an AF only intervention group; or an AF+AC intervention group. Extensive health and     exposure measures will be undertaken during the course of the 12 -month intervention. Given     the role of PM in children's asthma-related health and the higher concentrations of PM in     microenvironments, there is a need to test the efficacy and efficiency of novel approaches to     reducing indoor air pollutants. Doing so using a CBPR approach will enhance the relevance and     ultimately the success of this proposed research.   "
229071|NCT00839293|"     The purpose of this study is to evaluate the safety and compare the bioavailability of     fenofibric acid from 2 different dosage strengths of ABT-335.   "
229072|NCT00839306|"     The purpose of this study is to compare the efficacy of rabeprazole extended release 50 mg     (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in     subjects with healed erosive gastroesophageal reflux disease (eGERD).   "
229054|NCT00839059|"     This is a Phase I, open-label, multi-center, dose-escalation study of lenalidomide in adult     patients with newly diagnosed, relapsed or refractory acute myeloid leukemia. All patients     will receive lenalidomide per oral daily (starting dose is 25 mg/d). Cohorts of 3 patients     (to be expanded up to 6 if 1 dose-limiting toxicity (DLT) is observed among the first 3     patients) will be sequentially allotted to progressively higher dose levels of lenalidomide     on the basis of the presence and severity of lenalidomide-related toxicity or lenalidomide     related serious adverse reactions encountered in the first cycle. For the purpose of this     study, patients' enrollment will continue until the maximum tolerated dose (MTD) will be     determined and characterized.   "
229055|NCT00839072|"     The objective of the study is to compare the pharmacokinetic profiles of extended-release and     immediate-release trazodone formulations   "
229056|NCT00839085|"     Study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress     induced by on pump coronary artery by pass grafting surgery.   "
229092|NCT00839566|"     Examination of CRT efficacy in patients with progressive heart failure and atrial     fibrillation at the same time   "
229060|NCT00839137|"     The purpose of the study is to determine if a program of regular exercise can help reduce     asthma symptoms and also reduce the inflammation caused by asthma. If successful, this would     allow regular exercise to be recommended as a therapy for people with asthma, which could     possibly reduce the amount of medicine that people with asthma need to control their asthma     symptoms.   "
229061|NCT00839150|"     The primary purpose was to assess, in diabetic patients without diabetic retinopathy and     control subjects, color vision, contrast sensitivity, electroretinography, and     flicker-induced vasodilatation using the Dynamic Vessel Analyzer, in order to specify the     earliest impaired retinal cells in diabetes, and gain more insight into diabetic retinopathy     pathogenesis.   "
229062|NCT00839163|"     The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety     and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to     find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future     clinical use.   "
229063|NCT00839176|"     The primary objective of this Phase IIa trial is to determine the effective dose and     treatment period for an upcoming RX-10100 Phase IIb trial in subjects with major depression     disorder (MDD). The secondary objectives of this trial are to evaluate the safety and quality     of life in subjects with MDD receiving RX-10100 treatment.   "
229064|NCT00839189|"     The purposes of this pilot safety study are to identify a dose of inhaled Clinical Center     Reference Endotoxin (CCRE) that is well tolerated by allergic subjects that induces     measurable increases in neutrophil content of induced sputum that can be employed to screen     large populations for susceptibility to the inflammatory effect of inhaled endotoxin.   "
229065|NCT00839202|"     A novel immuno-assay is being evaluated for the measurement of Factor VIII. Current procedure     measures a rate assay which is subject to much artefact. The hypothesis is that the new assay     will give a reading of absolute quantities of FVIII which will provide a more suitable     indicator of FVIII content for clotting factor manufacturers, physicians and patients.   "
229066|NCT00839228|"     Up to half of all patients with clinical features of heart failure are found to have normal     heart pumping function. Recently the investigators have shown that a drug called perhexiline     markedly improved exercise capacity and symptoms in patients with heart failure associated     with impaired cardiac pump function. In this proposal the investigators will assess whether     perhexiline has beneficial effects in patients with heart failure and a normal heart pumping     function.   "
229067|NCT00839241|"     The primary objective of the study is to compare the immunological status after either     autologous blood transfusion as administered by Bellovac® ABT or allogenic blood transfusion,     with regards to change in Natural Killer (NK) cell frequency in patients undergoing total     knee replacement.   "
229068|NCT00839254|"     The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal     conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H.     influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy     tube placement and outpatient antimicrobial prescriptions in children starting vaccination     below 18 months of age. These data will be collected from the national registers and will be     analyzed in combination with data collected for subjects enrolled in a large scale     cluster-randomized study 111442.      The study will also assess the immune response to the GSK1024850A vaccine and the impact of     the vaccine on occurrence of acute otitis media, carriage, safety in children starting     vaccination below 18 months of age.   "
229069|NCT00839267|"     The purpose of this study is to compare clopidogrel effectiveness between severe     hemodynamically unstable versus stable patients with acute myocardial infarction.   "
229070|NCT00839280|"     The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol     formulations   "
229074|NCT00839332|"     The purpose of the Phase 1 portion of this study is to determine the safe dose of LY2603618     when given 24 hours after gemcitabine. This dose will then be used for the Phase 2 portion of     the study. The Phase 2 portion of the study will evaluate whether LY2603618 when administered     24 hours after gemcitabine therapy is an effective treatment for patients with pancreatic     cancer.   "
229075|NCT00839345|"     The purpose of the study is to determine, whether the resistance to clopidogrel could be     affected by higher doses of this drug, or by replacement of clopidogrel with another     ADP-antagonist ticlopidine.   "
229076|NCT00839358|"     The aim of this study is to evaluate the effect of prolonged administration of albumin and     midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic     encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver     transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver     transplantation will include in the study. Patients will be randomized to receive albumin and     midodrine (treatment group) or administration of placebo (saline for albumine) and tablets     with excipients without midodrine (control group). Patients will be followed-up during 12th     months. In the treatment group albumin will be given at a dose of 40g every 15 days and     midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment     that patients require by cirrhosis. The group control will receive placebo in the same way     than the treatment group in addition with lactitol and the specific treatment that they     require by their disease. In all the patients liver and renal function test, hormones     determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal     conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months.     Before the inclusion in the study neuropsychological test and critical flicker test will be     performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months.     All the determinations will be repeated at any time that the patients develop any     complication considered as an end point. In baseline conditions and at 3rd and 6th months a     questionnaire of quality of life (SF36) will be performed. During a year of follow-up the     number of paracentesis that patients require, the incidence of renal failure and EH and their     relationship with hormonal activity and cytokine levels, free transplant survival and quality     of life will be recorded.   "
229077|NCT00839371|"     Bronchoscopy is performed on a daily basis for diagnostic and therapeutic purposes. This     procedure may cause anxiety and discomfort requiring the use of sedative drugs.      In this study the investigators titrate the administration of sedatives using bispectral     analysis of the EEG. The investigators compared 2 drugs, propofol versus midazolam regarding     patient subjective tolerance, recovery of brain function, safety and operator's satisfaction.   "
229078|NCT00839384|"     The purpose of the Advisa IPG clinical study is to evaluate the overall system safety and     clinical performance of the Advisa DR Implantable Pulse Generator (IPG).   "
229079|NCT00839397|"     This was a 52-week, non-comparative, uncontrolled study of paroxetine in Japanese PTSD     patients to obtain clinical experience regarding efficacy and safety. In this study, subjects     received paroxetine 20mg-40mg once daily after an evening meal.   "
229144|NCT00840268|"     The purpose of this study is to demonstrate efficacy of Hydroxypropyl Guar Galactomannan     0.25% (HPGG) ophthalmic gel compared to Vehicle for the treatment of dry eye.   "
229080|NCT00839410|"     This is a multicentric prospective cohort of all stage melanoma patients from AP-HP ,the     largest consortium of University hospitals over Europe. 7 investigation sites (7     dermatological services of AP-HP) in Ile de France region are involved. 1300 patients will be     enrolled and be followed during 10 years.   "
229081|NCT00839423|"     The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and     tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive     Disorder (MDD).   "
229082|NCT00839436|"     Background:        -  Idiopathic CD4 lymphocytopenia (ICL) is a condition in which patients have low levels of          T cells, a type of white blood cell that helps fight infection. Animal studies have          shown that an experimental drug Interleukin 7 (IL-7), which is named CYT107, can          increase the number and function of T cells. CYT107, however, has not been used in          people with ICL.      Objectives:        -  To determine the safety of CYT107 in people with ICL.        -  To determine whether CYT107 will increase the number and function of T cells in people          with ICL.      Eligibility:        -  Patients 18 years of age and older diagnosed with ICL and who are at risk of becoming          sick because of this condition are eligible for this study. In addition, patients must          not be pregnant, or have other illnesses that would cause low CD4 T cell counts, such as          human immunodeficiency virus (HIV) or human T-lymphotrophic virus (HTLV) infection.      Design:        -  The initial screening visit will include the following examinations and tests:        -  A complete physical exam and medical history        -  Blood analysis, including CD4 T cell count; complete blood count and additional blood          tests to determine clotting ability and blood composition; thyroid, liver, kidney, and          pancreatic function tests; HIV and HTLV tests; and tests for anti-IL-7 antibodies that          block normal IL-7 activity        -  Routine urine test        -  Urine or blood pregnancy test for women        -  Chest X-ray        -  Electrocardiogram        -  Spleen ultrasound.        -  The baseline visit will include blood tests to determine levels of each of the major          types of antibodies, a test of genetic background, and more detailed CD4 and protein          analysis. In addition, leukapheresis (a procedure to collect large numbers of immune          cells without red blood cells) will be done. Participants will also have the option of          having colon and lymph node biopsies.        -  The schedule will be as follows:        -  Weeks 1, 2, and 3 (Cycle 1): Three weekly IL-7 dosing visits.        -  Weeks 5, 8, and 12: Follow-up visits.        -  Weeks 24, 25, and 26 (Cycle 2): Three more weekly IL-7 dosing visits.        -  Weeks 28, 31, and 35: Follow-up visits.        -  Week 48: End of study visit.        -  Tests conducted before getting IL-7 will be repeated during the IL-7 cycles and          follow-up visits to compare with earlier values. Optional colon and lymph node biopsies          done at baseline will be repeated 1 6 weeks prior to Cycle 2 and 1 6 weeks prior to Week          48.   "
229083|NCT00839449|"     Cerebral vasospasm following subarachnoid hemorrhage (SAH) is the most common cause of     morbidity and mortality. Recent studies indicate that Rho-kinase play an important role in     the occurrence of such cerebral vasospasm. Eicosapentaenoic acid (EPA) inhibits     sphingosylphosphorylcholine (SPC)-induced Rho-kinase activation in vitro. So this study     examines whether EPA prevents cerebral vasospasm occurrence after SAH in patients.   "
229084|NCT00839462|"     The study focuses to prove the equivalent efficacy of two different Dexpanthenol     formulations.   "
229085|NCT00839475|"     The purpose of this study is to demonstrate the CervicalMD device's ability to collect     digital imagery suitable for a colposcopy examination.   "
229086|NCT00839488|"     Although stress ulcer is a complication that can cause significant mortality and morbidity in     critical patients with risk factors, there is still lack of consensus about its prophylaxis.     There are also few data available from Taiwan. H2 blockers are commonly used due to     convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less     association with nosocomial pneumonia. Recently, proton pump inhibitors were shown to have     good prophylactic effects for stress ulcer. Pantoprazole (iv) is the first intravenous form     of proton pump inhibitor that was approved by FDA. There are some reports about its     application for treatment of peptic ulcer bleeding. It also has good acid suppression effect     in patients under critical care. We expect that intravenous pantoprazole will have a role in     stress ulcer prophylaxis.      We will enroll those patients that have received major abdominal surgery and admitted to     surgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7 days     within 24 hours. They are randomly allocated to 2 groups. Group I: pantoprazole 40 mg iv     bolus stat and then qd ; Group II: famotidine 20 mg iv bolus stat and then q12h. We will     monitor the following data: operation type & time, APACHE II score, CBC, CXR, stool character     and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopic examination     will be performed. We define the end point as overt bleeding, death or transfer out of ICU.     We will compare the prevalence of UGI bleeding and ventilator associated pneumonia in these 2     groups   "
229087|NCT00839501|"     Andersen-Tawil Syndrome (ATS) is a rare genetic disorder that causes episodes of muscle     weakness, potentially life-threatening changes in heart rhythm, and skeletal developmental     abnormalities. The cause of some ATS cases remains unknown, and no specific treatments have     been established. The purpose of this study is to determine whether potassium supplements     and/or the medication acetazolamide affect the duration of muscle weakness and heart rhythm     abnormalities in people with ATS.   "
229088|NCT00839514|"     This study is to follow-up with workers from a local company that had exposure to TCE that     may have symptoms of Parkinson's disease. We hope to learn more about TCE exposure and     Parkinson's disease. Eligible participants will be those who participated in previous     research study entitled Survey of Selected Exposures and Neurologic Symptoms in an     Industrial Population   "
229089|NCT00839527|"     The purpose of this study is to determine the safety and efficacy of albiglutide in subjects     with type 2 diabetes   "
229090|NCT00839540|"     The purpose of this pharmacokinetic (PK) and pharmacodynamic (PD) study is:      To study the rate and duration of serum cidal activity of caspofungin (CFG) and micafungin     (MFG) against Candida isolates from the subject and against Candida glabrata with varying     degrees of caspofungin susceptibilities.      This investigation will provide clinicians information supporting the use of caspofungin and     micafungin in situations where Candida strains may be a cause of infection.   "
229091|NCT00839553|"     The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first     episode, and the optimal treatment remains unknown. In the recently published British     Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment     for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of     this procedure was as high as 25-30%, making it inappropriate as a standard of care.      Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way     to shorten the duration of air leaks and reduce the rates of recurrent spontaneous     pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline,     talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous     pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer     available. Talc insufflation of the pleural cavity is safe and effective for primary     spontaneous pneumothorax. However, it should be applied either with surgical or medical     thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in     inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional     minocycline pleurodesis is a safe and convenient procedure to decrease the rates of     ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In     the present study, additional minocycline pleurodesis will be randomly administered in     patients with first episode of primary spontaneous pneumothorax after simple aspiration. The     primary goal is to test if intrapleural minocycline can reduce the rate of recurrence. The     secondary goals are to evaluate the safety profile, short-term results, and long-term effects     of minocycline pleurodesis after simple aspiration. The sites of study include National     Taiwan University Hospital and Far Eastern Memorial Hospital. A total of 300 patients (150     patients in each arm) will be included for this study.   "
229093|NCT00839579|"     Exercise training is proved to protect against premature cardiovascular mortality.     Additionally there is evidence that relatively high exercise intensity may be an important     factor for improving aerobic capacity and endothelial function in patients with     post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in     overweight and obese individuals.      The aim of this study is to investigate the amount of high-intensity exercise needed to     improve aerobic capacity and endothelial function.   "
229094|NCT00839592|"     This is a randomized controlled trial to evaluate acupuncture treatment on insomnia in the     adult population in Hong Kong.   "
229095|NCT00839605|"     The purpose of this study is to evaluate the effects of Dexmedetomidine when used during     thoracic surgery.      The primary outcome will be changes in oxygenation as measured the PaO2 during one lung     ventilation.   "
229096|NCT00839631|"     This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric     coated D-3263 HCl in subjects with advanced solid tumors   "
229097|NCT00839644|"     The purpose of this study is to compare the effect of three airway secretion clearance     techniques (chest physical therapy, flutter device and high frequency chest wall oscillation)     on decline in pulmonary function over a three year period in patients with cystic fibrosis.   "
229098|NCT00839657|"     Individuals taking warfarin often need frequent dose changes as the international normalized     ratio (INR) gets too high or too low which could result in a higher risk of thromboembolism,     bleeding and early discontinuation of a highly useful therapy. This study will compare two     approaches to warfarin dosing to examine the utility of using genetic information for     warfarin dosing.   "
229099|NCT00839670|"     The purpose of this trial is to compare the effect of a modified constraint induced therapy     to the treatment described originally by Taub et al.. This study will determine if LICITE     will lead to similar improvements than the original described method.   "
229100|NCT00839683|"     Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin     and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and     dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of     valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK     of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects   "
229101|NCT00839696|"     Mammographic density is sensitive to estorgen exposure and constitutes a strong intermediate     maker of breast cancer risk. We hypothesize that women with higher serum xenoestrogen levels     will have greater mammographic density.   "
229102|NCT00839709|"     Rejection and infection are primary causes of morbidity and mortality in solid organ     transplant recipients. Current clinical practice relies on immunosuppressive drug levels     measured in plasma to reflect the peripheral immune response in solid organ transplant     recipients. Direct measurement of the number and functions of the immune cells themselves     using multi-parameter flow cytometry may enable individualized immunosuppression management     for organ transplant recipients. Multi-parameter flow cytometry will be used to compare     levels and functional capabilities of multiple lymphocyte subsets between cohorts of patients     receiving depletion induction and those receiving a non-depletion regimen. The activation     state, cytotoxic potential and the functional capabilities of these cells will be examined     within patients over the first six months post transplant.   "
229103|NCT00839722|"     The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas     embolization, in women between 18 and 40 years old.   "
229104|NCT00839735|"     The study focuses on trefoil family factor (TFF) peptides in sputum in lung diseases. The     investigators hypothesize that TFF peptides are upregulated in lung diseases characterized by     mucus hypersecretion.   "
229106|NCT00839761|"     Background: How best to improve iron status among infants in low-income settings is of     continued concern in many countries, including Brazil      Objective:      Design: In a double blind, 5-mo, home-based trial in Brazil, mildly anemic 6 - 24 month-old     children (n=175) were randomly assigned to receive either Ultra Rice (URG) fortified with     23,4, mg Fe as micronized ferric pyrophosphate (MFP) and a placebo solution of iron drops, or     identical non-fortified rice (CG) and a solution of iron drops. Parents were instructed on     the correct dosage of iron drops and to feed their children (including whether and how much     rice) as they normally would. Iron status and hemoglobin (Hb) were measured at baseline and     at 5 mo.   "
229107|NCT00839774|"     The purpose of this study is to determine if whole and fractionated yellow pea flour,     administered at USDA recommended dosages (50 g/day), improve risk factors associated with     cardiovascular disease and diabetes.   "
229108|NCT00839787|"     Surgeons are the individuals who will operate on a patient if it is determined to be     necessary after they present with abdominal pain. For that reason, the investigators want to     study if giving a medicine (morphine) to children presenting to the ED with abdominal pain     will alleviate pain without changing the patient's physical exam and the subsequent surgeon's     decision.      The investigators also will record any side effects of morphine, any associated surgical     complications, and to identify the ultimate diagnosis.   "
229109|NCT00839800|"     The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort     Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler     160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma     therapy   "
229110|NCT00839813|"     The central question in this research proposal is: can a popular technique that specifically     targets active mastery and improved affect regulation, yoga, which is utilized by     approximately 4% of the US population each year (1), improve the constellation of PTSD     symptoms, multiple somatic complaints, social and occupational impairment and high health     care utilization that has been documented in hundreds of thousands of women in the US?      The Primary Aims of this study include the following:        1. To test the short-term and long-term effectiveness of 10 weeks of yoga for treating          treatment-resistant PTSD and compare it with attention controls receiving Women's Health          Education (WHE).        2. To assess the short-term and long-term effects of yoga on a) co-morbid conditions, b)          quality of life, c) body awareness, d) health care utilization and e) heart rate          variability (HRV), in comparison to an attention control group.   "
229111|NCT00839826|"     Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to     60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as     heparins, significantly lowers that risk, but heparins have to be applied below the skin     (subcutaneously). Additionally, there is a chance of developing a heparin-induced     thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents     which are safer and more efficient and which are easier to apply.The purpose of this study is     to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the     licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and     widely used in the area of thromboprophylaxis and will be given once daily     subcutaneously.Another important purpose of the study is to find the optimal dose of BAY     59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several     dose steps planned.   "
229112|NCT00839839|"     University Reproductive Associates is conducting a pilot study to study the technique of egg     freezing. Your participation in this study will provide us with important information to     allow us to offer this technology for women wishing to freeze their eggs before cancer     treatments. Your participation will include a standard IVF cycle with your eggs being frozen     for a brief period of time and then transferred back to you as usual. You will receive a     significant reduction in your IVF cycle cost.   "
229113|NCT00839852|"     This is an outpatient study to evaluate the long-term safety, tolerability, and     pharmacokinetics of cariprazine in patients with Schizophrenia.   "
229114|NCT00839865|"     The purpose of this study is to determine if dressing change with a kind of herb Yuyang     ointment is clinically more efficacious and safer than Conventional treatment in the     treatment of diabetic foot ulcers.   "
229115|NCT00839878|"     This study is conducted in Asia. The aim of this observational study is to evaluate current     status of diabetes management, control, complications in diabetic subjects in Asia.   "
229116|NCT00839891|"     -  Determine whether VI-0521 has an effect on the electrical activity of the heart in          healthy subjects.        -  Find out how much VI-0521 is in the blood and any potential side effects on ECG's of          healthy subjects after taking the study drugs.   "
229117|NCT00839904|"     Physical activity is a well-known and powerful tool in medicine,having preventive,     palliative, and curative properties. This has not been sufficiently examined in children in     remission from cancer. In this study, children in remission from cancer will be divided into     exercise and control groups. The interventional group will perform two supervised, 60-minute     weekly exercise sessions. Outcome measures of the exercise intervention will be quality of     life, mood, cardiorespiratory fitness, body composition and bone mineral density.   "
229118|NCT00839917|"     This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™     with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested     is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after     vaccination with ProQuad™ will be non-inferior to the antibody response rates after     vaccination with concomitant M-M-R™ II and Varivax™.   "
229119|NCT00839930|"     This study will compare the relative bioavailability (rate and extent of absorption) of 50 mg     Cilostazol Tablets manufactured by TEVA Pharmaceuticals Industries Ltd. and distributed by     TEVA Pharmaceuticals USA with that of PLETAL Tablets manufactured by Otsuka Pharmaceuticals     Co., Ltd. for Otsuka America Pharmaceutical, Inc. following a single oral dose (1 x 50 mg     tablet) in healthy adult subjects administered under fasting conditions.   "
229120|NCT00839943|"     The purpose of this study is to compare the effect of ozone exposure on airway reactivity and     inflammation in obese vs. non-obese adults.   "
229157|NCT00840450|"     This study is designed to determine whether the combination treatment of Paclitaxel and     Gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will     generate better clinical response than Paclitaxel alone.   "
229121|NCT00839956|"     This phase II trial studies the side effects of giving bortezomib together with vorinostat     and to see how well it works in treating patients with multiple myeloma who have undergone     autologous stem cell transplant. Bortezomib and vorinostat may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with     vorinostat after an autologous stem cell transplant may stop the growth of any cancer cells     that remain after transplant.   "
229122|NCT00839969|"     Urethral dilatation is a commonly undertaken intervention for a variety of urinary complaints     including overactive bladder symptoms. There is however very little evidence for its     efficacy, and no randomized trial evidence. The aim of this study is to ascertain the effect     of urethral dilatation on overactive bladder symptoms and on voiding parameters. The null     hypothesis is that there will be no difference in symptoms or voiding parameters between the     urethral dilatation and sham groups.      Eligible women will be assessed initially with a history and examination, a King's Health     Questionnaire and Bristol Female Urinary Tract Symptoms (BFLUTS) questionnaire and pressure     flow studies. They will be randomized to undergo either cystoscopy alone or cystoscopy and     urethral dilatation. Patients will be blinded to the procedure undertaken and randomized     using a series of opaque envelopes. Follow up will be at 6 weeks with repeat questionnaires     and pressure flow studies. Subjective and objective outcomes will be compared between the two     groups.   "
229123|NCT00839982|"     This phase I/II trial studied the side effects and best dose of clofarabine when given     together with cytarabine and to see how well they work in treating older patients with acute     myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) that have relapsed or not     responded to treatment.   "
229124|NCT00839995|"     The purpose of this study is to obtain coagulation profiles of patients undergoing     multi-level spine surgeries with ROTEM® and routine coagulation tests. The investigators will     compare the data from ROTEM® and routine coagulation tests with each other and with blood     loss and transfusion therapies used.   "
229125|NCT00840008|"     The purpose of this study is to assess whether adherence to NVUGIB guidelines is improved     with implementation of a national, tailored multifaceted intervention. Outcomes include     adherence rates to two key endoscopic and pharmacological therapy guidelines together     (primary), or adherence to these individually as well as to other recommendations     (secondary). Patient outcomes and economic data are also assessed (tertiary).   "
229126|NCT00840034|"     The primary purpose is to study the efficacy, safety, and tolerability of LY2216684 as an     adjunctive treatment for patients with major depressive disorder (MDD), who were identified     as partial responders to an adequate course of treatment with a selective serotonin reuptake     inhibitor (SSRI) (as defined by history).   "
229127|NCT00840047|"     The purpose of this study is to test the usefulness of imaging with radiolabeled methionine     in the evaluation of children and young adults with tumor(s). Methionine is a naturally     occurring essential amino acid. It is crucial for the formation of proteins. When labeled     with carbon-11 (C-11), a radioactive isotope of the naturally occurring carbon-12, the     distribution of methionine can be determined noninvasively using a PET (positron emission     tomography) camera. C-11 methionine (MET) has been shown valuable in the monitoring of a     large number of neoplasms. Since C-11 has a short half life (20 minutes), MET must be     produced in a facility very close to its intended use. Thus, it is not widely available and     is produced only at select institutions with access to a cyclotron and PET chemistry     facility. With the new availability of short lived tracers produced by its PET chemistry     unit, St. Jude Children's Research Hospital (St. Jude) is one of only a few facilities with     the capabilities and interests to evaluate the utility of PET scanning in the detection of     tumors, evaluation of response to therapy, and distinction of residual tumor from scar tissue     in patients who have completed therapy. The investigators propose to examine the     biodistribution of MET in patients with malignant solid neoplasms, with emphasis on central     nervous system (CNS) tumors and sarcomas. This project introduces a new diagnostic test for     the noninvasive evaluation of neoplasms in pediatric oncology. Although not the primary     purpose of this proposal, the investigators anticipate that MET studies will provide useful     clinical information for the management of patients with malignant neoplasms.   "
229128|NCT00840060|"     The goal of this proposal is to examine the efficacy of a manualized treatment intervention,     AMALS: Addressing Multiple Aspects of Language Simultaneously, which is designed to remediate     semantic, morphological, and syntactic aspects of language in preschool children with     language impairment. This study will target preschool children with language impairment     living in a region characterized by nonmainstream dialects.      Questions driving this work are:        1. Will children participating in the AMALS treatment exhibit greater semantic,          morphological, and syntactic complexity on multiple outcome measures at the completion          of the intervention compared to a Discrete Trial Approach (DTA) group?        2. Will these gains be maintained at one-month follow up?        3. What is the impact of dialect on dependent variables, specifically morphosyntactic          abilities?      To answer these questions a randomized clinical trial will be conducted comparing AMALS, an     integrated approach to treatment, with DTA, an additive approach to therapy. In this study     rather than restrict the ethnic and cultural backgrounds of this population, children's use     of dialect will be uniquely identified and examined.   "
229129|NCT00840073|"     The objective of this study is to evaluate the comparative bioavailability between     trandolapril 4 mg tablets (test) and Mavik® 4 mg Tablets (reference) after a single-dose in     healthy subjects under fed conditions.   "
229130|NCT00840086|"     This trial is conducted in Asia, Europe, and North and South America. The trial consists of a     main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog     alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial     investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding     episodes during surgical procedures.   "
229131|NCT00840099|"     The objective of this study is to assess the bioequivalence between Amoxicillin and     Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral     Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fasting conditions.   "
229155|NCT00840411|"     The objective of this study is to compare the relative bioequivalence of a test     clarithromycin extended release formulation to an equivalent oral dose of the commercially     available extended release clarithromycin in a test population of 66 adult subjects under     fasting conditions.   "
229132|NCT00840112|"     Purpose:      People with a genetic defect in the ability to burn fat can also develop a problem with the     nerves in their feet. The nerve problem, or neuropathy, can limit their ability to walk. Part     of the treatment of their genetic defect in the ability to burn fat is to eat a very low fat     diet. Vitamin E is found only in fatty foods like oils and nuts. People with a genetic defect     in the ability to burn fat may have low vitamin E because of their low fat diet. The purpose     of this study is to test whether vitamin E supplements can improve the nerve function in the     feet of people with a genetic defect in the ability to burn fat.      Procedures:      Blood samples will be drawn at the beginning of the study, after 2 months and after 6 months     of vitamin E supplements. The blood will be analyzed for plasma vitamin E concentrations.     Around the time of each blood draw subjects will record all the food and beverages he or she     consumes for three days. The subject will send the record to the investigator. Subjects will     have a physical exam by a doctor specializing in nerves, a neurologist before and after     taking vitamin E. They will have nerve function measured with a test called a nerve     conduction velocity or NCV. Subjects will be given 800 international units (IU) of vitamin E     per day for 6 months.   "
229145|NCT00840281|"     The objective of this study is to compare the relative bioavailability of cefprozil 500 mg     tablets (Teva Pharmaceuticals USA) with that of Cefzil® 500 mg tablets (Bristol-Myers Squibb)     in healthy, non-smoking adults under fasting conditions.   "
229146|NCT00840294|"     The purpose of this study is to assess the impact of an empiric course of antibiotics for men     with an elevated prostate-specific antigen (PSA) level.   "
229147|NCT00840307|"     This study evaluates how ectopic fat (in the pancreas, heart, liver and skeletal muscle),     visceral fat, and subcutaneous fat changes following surgically induced weight loss using     gastric banding. The investigators also evaluate whether changes in pancreatic fat content     correlate with improvement in beta-cell function.   "
229148|NCT00840320|"     The purpose of this study is to characterize the safety and tolerability of repeat doses of     compound 1278863A in healthy subjects.   "
229187|NCT00852241|"     The primary objective of this study is to determine the efficacy and longevity of the use of     Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and     to measure patient satisfaction with this treatment   "
229133|NCT00840125|"     Study Rationale:      There is increasing evidence that erlotinib improves overall survival in selected patients     with stage IIIB-IV NSCLC. Furthermore, pre-clinical and phase II studies have shown a     potential for synergism between erlotinib and docetaxel. This study will further evaluate the     effects of combination treatment on overall survival in selected NSCLC patient population.      Based on recent published data, the treatment cycle in this study will be 22 days with two     infusions (Day 1 and Day 8 of each cycle). This is different from the standard therapy care     of 28-day cycle (three infusions on Days 1, 8 and 15). The shorter 22-day cycle was shown to     be just as effective as the 28-day cycle and is expected to increase subject compliance and     decrease chemotherapy-induced toxicity.      Study Objectives:      The primary objective is to demonstrate superiority in progression-free-survival, when     erlotinib is added to docetaxel.      The secondary objectives are to determine:        -  Overall survival (defined as the time period from the start of first-line therapy to          death)        -  Time to treatment failure or disease progression (defined as the time period from the          start of first-line therapy to investigator assessed disease progression)        -  Tumor response rate and duration        -  Safety profile        -  Quality of Life improvement        -  microRNA profile (assessed from human lung biopsy and/or cytology samples) at screening          for prognostic purposes   "
229134|NCT00840138|"     In this prospective study the investigators compared common bile duct injuries (CBDI)     following laparoscopic cholecystectomy (LC) and open cholecystectomy (OC) procedures, 35     patients in each group. To date, no detailed study concerning this matter has been published.     LC - CBDI in comparison with OC - CBDI more often concerned young females with a narrow CBD,     they were located closer to the liver hilus, and they were more extended.   "
229135|NCT00840151|"     The purpose of this study is to compare different forms of treatment for substance abuse.     This study will involve a type of treatment called contingency management, in which patients     receive incentives (prizes) for attending outpatient treatment. This study will compare     contingency management to standard treatment that does not involve incentives. This study     will also compare contingency management treatment that lasts 6 weeks to contingency     management that lasts 12 weeks. Finally, this study will compare contingency management     treatment delivered at the beginning of outpatient treatment to contingency management     treatment delivered later during outpatient treatment. The investigators hypothesize that (1)     a 12-week attendance-based contingency management intervention will improve retention and     enhance drug abstinence versus standard treatment, (2) initial short-term exposure to     attendance-based contingency management (in weeks 1-6 only) will improve substance abuse     treatment outcomes compared to standard treatment alone, and (3) contingency management in     weeks 7-12 will be particularly useful for those with sporadic attendance or continued drug     use during initial stages of treatment.   "
229136|NCT00840164|"     1. To explore the pathology of nerve, vascular, and skin in the amputated leg        2. To diagnose small-fiber sensory neuropathy of the contralateral leg by investigating the          skin intervention        3. To search for (1) mechanisms of amputation and (2) prevention measures for further          amputation in the currently healthy-looking limb   "
229137|NCT00840177|"     RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by     making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together     with pravastatin may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together     with pravastatin works in treating patients with relapsed acute myeloid leukemia.   "
229138|NCT00840190|"     This is a phase I open label study to evaluate safety and efficacy of P1446A-05 in subjects     with advanced refractory malignancies. Subjects of solid tumors or hematologic malignancies     will be included. This is a dose escalation study following an accelerated titration design.     It is expected that around 50 subjects would be enrolled in the study.Safety assessment will     be conducted on the basis of vital signs, physical examination and laboratory investigations     undertaken at regular intervals as per the schedule.   "
229139|NCT00840203|"     The objective of this study is to evaluate the relative bioavailability of the test     formulation of mesalamine suspension rectal enema with the already marketed reference     formulation Rowasa® in healthy, adult subjects.   "
229140|NCT00840216|"     The objective of this study is to compare the relative bioequivalence of a test     clarithromycin extended release formulation to an equivalent oral dose of the commercially     available extended release clarithromycin in a test population of 22 adult subjects under fed     conditions.   "
229154|NCT00840398|"     This study will compare the relative bioavailability (rate and extent of absorption) of 30 mg     Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 30 mg     BUSPAR® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 30 mg     tablet) in healthy adult volunteers under non-fasting conditions.   "
229156|NCT00840437|"     The health and well being of patients with refractory angina will be assessed using validated     questionnaires (SF-36 and Seattle Angina Questionnaire [SAQ]) at baseline and one year.   "
229141|NCT00840229|"     The purpose of this study is to compare ultrasound guided capsular corticosteroid injection     into the rotator interval/anterior capsule and the GH joint with ultrasound guided     corticosteroid injection into the GH joint only. Both methods will be compared with placebo     injections.      Primary outcome measure: pain reduction at week 6 Secondary outcome measures: improvement of     function (SPADI, Life quality, ROM).      0-hypothesis: no difference between the methods.      The investigators want to find out if the clinical effect of the combined capsular and     intra-articular injections are better than placebo and better that intra-articular injections   "
229142|NCT00840242|"     The purpose of this study is to test the success rate of smoking reduction or cessation with     different nicotine products.   "
229143|NCT00840255|"     The purpose of this study is to adapt and test the effects of a 4-week behavioral treatment     that targets chronic insomnia (lasting >1 month) in service members returning from Operation     Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), finalizing a treatment manual.   "
229185|NCT00852215|"     We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large     vessels compared with bare metal stent.   "
229149|NCT00840333|"     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which     has been particularly problematic to eradicate and been implicated as the major cause of     morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung     increases the local concentrations of antibiotic at the site of infection resulting in     improved antimicrobial effects compared to systemic administration. Bacterial resistance to     current aerosol antibiotic treatments indicate a need for improved therapies to treat CF     patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and     other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to     have antimicrobial effects on even the most resistant organisms. MP-376 is a novel     formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery     using the PARI electronic eFlow® nebulizer. Preclinical and early clinical studies in adults     show that aerosol doses of MP-376 appear to be safe and well tolerated, and exert an     antimicrobial effect when administered once or twice daily. High concentrations of     levofloxacin in the lung delivered using MP-376 are expected to be active against CF     pathogens such as P. aeruginosa and S. aureus, including those resistant to aminoglycosides     (such as TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered     rapidly and efficiently using the PARI eFlow® nebulizer system. This Phase 1 study is being     performed to obtain safety, tolerability and PK data in children ages 6-16 in order to     determine if MP-376 is safe, prior to enrolling children of these ages in the planned pivotal     Phase 3 studies.   "
229150|NCT00840346|"     This protocol is a multicenter, national, open-label, single-arm, non-controlled study     designed to establish the efficacy (in terms of response and survival) and safety of     panobinostat in combination with idarubicin and cytarabine and in monotherapy in patients     with newly-diagnosed AML aged 65 years or older.   "
229151|NCT00840359|"     The aim of the project is to determine whether daylight activated photodynamic therapy is     effective in treating cutaneous leishmaniasis caused by L. major and L. tropical.      PDT is classically performed as a two-step procedure in which MAL application to the lesion     constitutes the first step, and PpIX activation by light of appropriate wavelength from an     artificial light source constitutes the second step. Based on the knowledge that red and blue     light required to activate PpIX are part of the daylight spectrum, the investigators     postulated that effective PpIX activation can be obtained by exposure of the MAL treated     lesions to daylight thus substantially simplifying the PDT procedure by omitting the 3 hour     incubation period and the subsequent exposure to artificial light. In accord, in a recent     study the investigators showed that daylight-activated PDT (DA-PDT) was as effective as     conventional MAL-PDT in treating precancerous actinic keratoses lesion. Furthermore the     investigators found that DA-PDT is significantly less painful than conventional MAL-PDT.      The investigators now propose to study the efficacy of DA-PDT in the treatment of cutaneous     leishmaniasis. DA-PDT has obvious advantages to conventional leishmania treatment forms:      As opposed to most of the available treatment options, DA-PDT is a self-administered     procedure that does not require the assistance of medical personnel. Secondly, judged by our     experience with MAL-PDT, only few treatment sessions are required for effective parasite     killing as opposed to the prolonged procedures usually required for treatment of     leishmaniasis. Third, PDT has the far the best safety profile of all available treatment     options.   "
229152|NCT00840372|"     The aim of this observational study in patients chronically hemodialyzed by a native     arterio-venous fistula is to determine the impact of the use of semi-blunt needles on the     quality of the punction. The investigators have observed that cannulation with blunt needles     (button-hole method) is sometimes difficult and the use of a sharp needle may be necessary,     with consequently more hematomes and infections. Our hypothesis is that canulation with     semi-blunt needles would be easier than with classical blunt needles, and consequently the     use of sharp needles would become less frequent.      Inclusion criteria and study design are detailed below.   "
229153|NCT00840385|"     The primary objective of this study is to evaluate the efficacy of Fludarabine, Adriamycin     and Dexamethasone (FAD) as first line therapy in patients with Peripheral T-cell lymphomas     (PTCL). 30 patients will be treated into this study.   "
229158|NCT00840463|"     This is a randomized study of ambrisentan that will last 16 weeks. The study will include     patients with diastolic heart failure and pulmonary hypertension. Patients will be randomized     (1:1) to ambrisentan or placebo. The ambrisentan or matching placebo will be started at 2.5     mg by mouth daily and increased to 5mg and then 10mg daily, if tolerated. Patients will be     seen at least monthly for 16 weeks. Adverse reactions will be reviewed and the required     monthly laboratory tests (liver function testing and pregnancy testing, if applicable), will     be performed. Patients will also complete an exercise test (six minute walk distance) and a     quality of life survey at the baseline, week 4 and week 16 visit. An echocardiogram and a     right heart catheterization and left ventricular end diastolic pressure measurement will be     performed at the 16 week visit. The primary end-point is safety, and secondary end-points     include the catheterization results, echocardiogram results, the walk distance and the     quality of life survey. The expected completion of the study is 18 months from initiation.     Ambrisentan is an FDA approved drug for PAH, but not for CHF.   "
229159|NCT00840476|"     The objective of this study is to compare the rate and extent of absorption of meloxicam from     a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under     fasting conditions.   "
229160|NCT00845845|"     The current pilot study assesses the use of magnetic resonance imaging (MRI) to quantify     hepatic steatosis. It will provide preliminary data regarding the use of omega-3 fatty acid     supplementation (Lovaza) for the treatment of nonalcoholic steatohepatitis (NASH).   "
229161|NCT00845858|"     To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray     solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic     gastroparesis.   "
229162|NCT00845871|"     This single-arm, open-label, multi-center study will enroll 60 patients from approximately 20     centers. All patients who meet study criteria and are currently taking, beginning or resuming     treatment with Deferasirox will be allowed. The study will begin with a one month run-in     phase, where all patients will be instructed to take Deferasirox according to their     physician's current prescribing information.   "
229163|NCT00845884|"     In spite of multiple attempts to improve the efficacy of first-line chemotherapy in advanced     gastric cancer, the progress that has been achieved so far is rather limited, and many     investigators are exploring newer regimens.A combination of decetaxel (Taxotere) with     Cisplatin and 5-fluorouracil (5FU) is considered one of the most effective regimens in this     disease. However, it is associated with significant toxicity which avoided its general     adaptation by the medical community. The current study is exploring a newer way to administer     these three drugs, hopefully making the regimen more comfortable, less toxic and maybe even     more effective. We will do this by changing the dose and timing of Taxotere and Cisplating,     by replacing protracted infusion of 5FU with tablets of Capecitabine (Xeloda) and by adding     the anti-angiogenic drug, Bevacizumab (Avastin), which had shown encouraging results in this     disease.   "
229164|NCT00845897|"     The purpose of this grant is to collect pilot data to assess the amount of botulinum toxin     that needs to be injected into the calf muscles of subjects with diabetes mellitus,     peripheral neuropathy, and a plantar ulcer to decrease muscle strength. We hypothesize that a     decrease in plantar flexor muscle strength will temporarily decrease plantar pressure. The     decrease in plantar pressure will provide temporary protection to the new tissue as it gains     tolerance to high stress with the long term potential outcome as a decrease in the ulcer     recurrence rate.   "
229165|NCT00845910|"     This single arm study will evaluate the correlation between circulating endothelial cell     levels and treatment efficacy in patients with locally recurrent and metastatic breast cancer     given first line treatment with Avastin in combination with docetaxel + Xeloda.Patients will     be treated with docetaxel 60mg/m2 iv on day 1, and Xeloda 900mg/m2 po on days 1-14, of each 3     week cycle, plus Avastin 7.5 mg/kg iv on day 1 of each 3 week cycle. The anticipated time on     study treatment is until disease progression, and the target sample size is <100 individuals.   "
229166|NCT00845923|"     This proof of concept study is designed to evaluate the safety and efficacy of topically     administered Civamide Patch for the treatment of moderate to severe daily pain associated     with postherpetic neuralgia localized to the trunk, and with localized post-incisional     neuropathic pain syndromes on the trunk.   "
229167|NCT00845936|"     Atypical antipsychotics (AA) are broadly used to treat a variety of psychiatric and     neurological disorders in children and adolescents. Weight gain is a common side effect of     these drugs. AA induced weight gain can be the cause of the metabolic syndrome which is a     major health concern, as well as cancer and significant psychological disorders. Weight gain     may also lead to low compliance with AAs.      A number of studies have been conducted in order to find a way to prevent, reduce or reverse     AA induced weight gain in children and adolescents, but so far there is no commonly accepted     treatment for the problem.      Metformin is an antihyperglycemic drug, approved by the FDA for treatment of type 2 diabetes     in children older than 10 years of age. The drug usually does not cause hypoglycemia, even in     high dosage. Contraindications include renal impairment, hepatic disease, a past history of     lactic acidosis (of any cause), cardiac failure requiring pharmacological therapy, or chronic     hypoxic lung disease. The drug also should be discontinued temporarily prior to the     administration of intravenous contrast media and prior to any surgical procedure. The     reported incidence of lactic acidosis during metformin treatment is less than 0.1 cases per     1000 patient-years, and the mortality risk is even lower.      Acute side effects of metformin, which occur in up to 20% of patients, include diarrhea,     abdominal discomfort, nausea, metallic taste, and anorexia. These usually can be minimized by     increasing the dosage of the drug slowly, when indicated, and taking it with meals.     Intestinal absorption of vitamin B 12 and folate often is decreased during chronic metformin     therapy, and calcium supplements reverse the effect of metformin on vitamin B12 absorption.      Three studies have studied the effect of metformin on weight gain secondary to use of AAs in     adults and 3 other studies studied the effect of metformin in children and adolescents. Most     of these studies have proved the drug to be efficient. No serious side effects have been     demonstrated in any of these studies.      Objective- To assess the effect of metformin on body weight of children and adolescents     treated by AAs.      Setting- recruitment and follow up would take place in the pediatric ward and outpatient     clinic at the Ness- Tziona Mental Health Center.      Participants- 30 adolescents aged 12- 20 years old, treated with AAs, who are overweight as     defined by more than 10% of what is expected according to age and height.      Importance of the Study        1. Identify a medication capable of reducing or preventing weight gain by an AA agent.        2. Identify an agent capable of improving compliance due to lower side-effect profile of          AAs.   "
229178|NCT00852124|"     We are proposing to test the safety of the probiotic, VSL#3, in a placebo controlled double     blind safety study in 30 asthmatic adults. This adult safety trial was requested by the FDA     IND review of a pediatric asthma protocol.      Adults with a doctor diagnosis of persistent asthma will take VSL#3 or placebo twice daily     for 3 months. Data will be collected, including age, race, height, and weight, present     medications, past medical history with emphasis on signs/symptoms of asthma.      On visits to the clinic we will evaluate        -  Changes in lung function        -  Intestinal permeability        -  Intestinal bacteria        -  Levels of inflammation in the blood        -  Women will have repeat urine pregnancy testing at each clinic visit   "
229168|NCT00845949|"     Rheumatoid arthritis is a common chronic destructive arthritis. Major pathology change in     rheumatoid arthritis is synovium hyperplasia with bone and cartilage erosion. Infiltrates in     synovial tissue included type one and type two synoviocytes, B cells, T cells and     fibroblasts. These cells will release many cytokines and chemokines, which will induce     expression of adhesion molecules, release of variable enzyme from fibroblast and osteoclast     and result in bone erosion.      Recent study revealed that fibroblast-like synoviocytes (FLS) have some role in pathogenesis     of rheumatoid arthritis.We believed CXCL12/CXCR4 ligand/receptor pair is important in     chronicity of rheumatoid arthritis.      CXCL12 polymorphism is studied in many disease. There is no related CXCL12 polymorphism study     in rheumatoid arthritis. Our study intended to clarify the relationship between pathology,     serology factor, CXCL12 polymorphism in rheumatoid arthritis in hope that new direction of     therapy will be elucidated.   "
229169|NCT00852007|"     This study investigates the use of the patients own immune cells to treat prostate cancer.     Cells are taken from the patient and grown in the laboratory to become specialized immune     cells called dendritic cells. Dendritic cells instruct other immune cells to recognize and     attack foreign substances such as bacteria, viruses, or abnormal proteins on cancer cells. A     protein called Tn-MUC-1 is added to the cells.This protein is present on prostate cancer     cells. The modified cells are injected back into the patient, with the intention that the     dendritic cells will instruct other immune cells to attack the prostate cancer cells.   "
229170|NCT00852020|"     To test the compliance, tolerance, safety and to get preliminary insights into the efficacy     of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and     antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic     heart failure (CHF) or chronic obstructive pulmonary disease (COPD).   "
229186|NCT00852228|"     The primary objective of the study is to increase by 15% the complete macroscopic resection     rate of predominantly liver metastases from metastatic colorectal cancer through combining     systemic cetuximab and hepatic artery infusion of three-drug chemotherapy (irinotecan,     oxaliplatin and 5-fluorouracil).   "
229171|NCT00852033|"     Alcohol abuse among college students is a significant and long-standing public health issue.     The transition into college is marked by substantial increases in alcohol abuse and problems,     suggesting the importance of interventions that take place prior to and immediately following     matriculation. To date, early interventions with this population have yielded modest results     with very little evidence identifying either the factors that are responsible for observed     effects or specific individual or situational factors that qualify intervention efficacy.     There is preliminary evidence for the efficacy of individualized feedback (IF) in reducing     college student alcohol abuse. Additionally, a sizeable body of research with early     adolescents and emerging work with college students point to the utility of parent-based     interventions (PBI). The major aim of this research is to provide the first test of the     unique and combined efficacy of these two successful interventions in reducing alcohol abuse     among matriculating college students.   "
229172|NCT00852046|"     Assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and     propofol while maintaining sedation in a mechanically ventilated patient in a general medical     intensive care unit.   "
229173|NCT00852059|"     This study determined to measure non-adherence assessed by the number of non-adherent days     during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS).      Study Design:        -  prospective        -  multi-centric        -  open-label        -  randomized        -  active-controlled trial   "
229174|NCT00852072|"     Removal of large bile duct stones can be technically challenging at ERCP. Particularly, when     the size of the stone is more than 1.2cm they are removed using a metal basket (lithotripsy).     This can sometimes be technically challenging and may require more than one ERCP session.     Recently, a balloon has been used to enlarge the opening of the bile duct (sphincteroplasty)     to help easy removal of stones in one ERCP session. There are no studies comparing the     lithotripsy and sphincteroplasty techniques. This randomized trial is designed to address the     question of which technique is superior for bile duct stone extraction: lithotripsy versus     sphincteroplasty.   "
229175|NCT00852085|"     To examine the effectiveness of four motivational counseling groups and a directed     observational experience in the emergency room in comparison to education and community     volunteering only, in reducing high risk driving behaviors   "
229176|NCT00852098|"     Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the     most common surgical treatment for gastro-esophageal reflux. Although this procedure is     effective, some patients still develop complications. Indeed, dividing the short gastric     vessels is claimed by many authors to confer benefit to patients even it could not be proved     in other studies. In an attempt to evaluate the role of dividing the short gastric vessels     and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the     investigators initiated a randomized clinical trial to clarify this important fact. Patients     were recruited for this trial and short-term results had been already published in a national     journal. The investigators are now registering this study which particularly focuses on the     endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical     treatment.   "
229177|NCT00852111|"     Background:        -  Researchers have studied the causes of fatigue during treatments for various diseases,          but these results have not been conclusive.        -  More information on the physical changes that affect the body during treatment may help          identify biological or chemical factors that contribute to patient fatigue, which may          allow physicians to identify individuals who may be more at risk of feeling fatigue          before, during, and after treatment for diseases such as cancer.      Objectives:        -  To identify factors contributing to fatigue in men who are undergoing radiation          treatment for prostate cancer.      Eligibility:        -  Men 18 years of age and older who are scheduled to receive localized radiation treatment          for prostate cancer.      Design:        -  Six outpatient visits to the NIH Clinical Center, approximately on the same day and same          time of day:        -  First visit before beginning radiation treatment.        -  Once a week for the first 2 weeks of the treatment, once at the midpoint of treatment,          once at the end of treatment.        -  Final visit 4 weeks after completion of radiation treatment.        -  Initial visit will involve a physical examination and questions about medical history.        -  Evaluations during the treatment period:        -  Blood draws to identify cells and chemicals associated with inflammation and fatigue.        -  Questions about physical activity, fatigue, depression, and quality of life.   "
248572|NCT01109056|"     This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05%     (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).   "
229180|NCT00852150|"     The modified Lanza scale (Lanza FL, 1984) has been widely utilized to grade the degree of     gastritis and duodenitis. However, the inter-rater or intra-rater reproducibility of this     scale has never been validated. As a quality improvement program, it is important to study     the reproducibility of the scale between different operators and the operators himself.      Method: During upper endoscopic examinations, one investigator performed the procedure and     the second investigator look at the endoscopic image. The degree of gastritis and duodenitis     is graded. The results of the grading are blinded to the other investigator.      The endoscopic video is stored for reassessment to determine the intra-rater reliability. The     patient identifier is stored in serial number. The investigator will not retrieve the report     of the first assessment during the second assessment.   "
229181|NCT00852163|"     The purpose of this study is to determine whether Clofarabine in combination with Busulfan is     effective as a preparative transplant regimen for the treatment of leukemia and     myelodysplastic syndromes   "
229182|NCT00852176|"     The study will evaluate the long-term safety and efficacy of intravascular beta radiation     therapy to treat coronary in-stent restenosis using the Beta-Cath(TM) 3.5F System; data will     be collected retrospectively on patients treated with the Beta-Cath™ 3.5F System in routine     clinical practice following FDA pre-market approval of the System. Outcomes will be reported     up to 5 years following treatment.   "
229183|NCT00852189|"     This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses     of EC0489 in patients with refractory or metastatic tumors who have exhausted standard     therapeutic options.   "
229184|NCT00852202|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of     cariprazine in the treatment of outpatients with bipolar depression.   "
229188|NCT00852254|"     A novel method to measure cardiac index based on ultrasound indicator dilution technology     (UIDT) has been developed by Transonic Systems Inc. (Ithaca, NY, USA). The method overcomes     many of the limitations that have plagued the existing techniques used to measure cardiac     index in critically ill children.      In the proposed investigation, the investigators hope to validate a novel application of an     existing technology in critically ill infants and children. The primary aim of this study is     to determine the accuracy of cardiac index measured by UIDT when compared to the     gold-standard Fick technique. The primary hypothesis is that the average of three consecutive     measurements of cardiac index by UIDT will be accurate when compared to the Fick technique.     Secondary aims will be to determine the precision of the measurement, the feasibility of the     technique with regards to time required and any complications encountered. An exploratory     secondary aim of this study is to determine whether central blood volume (CBV) derived from     indicator transit time (ITT) correlates with central venous pressure (CVP) and     echocardiography derived measures of preload.   "
229189|NCT00852267|"     The purpose of this study is to test whether replacing dietary carbohydrate with protein,     using beef as the primarily source of protein, will improve risk factors for cardiovascular     disease.   "
229190|NCT00852280|"     The purpose of this study is to identify changes in color, thickness, and stiffness, of scars     from skin grafting after burns when treated with a pulsed-dyed laser.   "
229191|NCT00852293|"     Chitinase and chitinase like proteins are members of the 18-glycosyl-hydrolase family.     Several reports have linked the chitinase 3 like 1 protein with colitis, asthma and liver     disease.      This study aims to evaluate the correlation of chitinase 3 like 1 protein with clinical     parameters such as disease severity, reaction to treatment, portal hypertension and     prognosis.   "
229192|NCT00852306|"     The purpose of this study is to determine the best way to freeze eggs in order to preserve     the fertility potential of young women.   "
229193|NCT00852319|"     The IPC program will enroll women who deliver Very Low Birth Weight babies (stillborn or     liveborn) at University of Mississippi Medical Center and women who have Very Low Birth     Weight babies that receive treatment in the Neonatal Intensive Care Unit at University of     Mississippi Medical Center and provide each woman with 24 months of funded comprehensive,     integrated, primary health care services (including family planning, social services, general     medical services,and basic dental care), and enhanced case management. The services will be     community-based (via UMC Clinics, community health centers, and outreach programs) and will     be provided by a multidisciplinary team of physicians, nurses, social workers, case managers,     and Resource Mothers/Resource Workers. At the end of project follow-up, we will evaluate the     success of the program in terms of improvement of general health status of enrolled women,     and subsequent reproductive health outcomes (i.e., achieving reproductive intentions,     intendedness and spacing of subsequent pregnancies, birth weight distribution of subsequent     pregnancies) and cost of delivery services compared to reproductive health outcomes in the     project's control population.   "
229194|NCT00852332|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary     supplements, such as phytochemicals, may stop or delay the development of breast cancer. It     is not yet known whether giving docetaxel together with a phytochemical is more effective     than giving docetaxel alone in treating patients with breast cancer.      PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with a     phytochemical works compared with giving docetaxel alone as first- or second-line therapy in     treating patients with breast cancer.   "
229243|NCT00853905|"     The investigators hypothesize that intracameral Triesence during glaucoma surgery will     provide lower intraocular pressure through better control of ocular inflammation, thus     leading to a more successful filtering procedure.   "
229195|NCT00853268|"     The objective of this open-label, randomized, two-period, crossover study was to evaluate the     oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of     oxycodone 40 mg compared to an equivalent oral dose of a commercially available     controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.) in a test group     of healthy subjects under fed conditions.   "
229196|NCT00853281|"     In Central Vietnam, forest malaria remains difficult to control due to the complex     interactions between human, vector and environmental factors. Untreated bednets had a     significantly protecting effect for villagers, except for those regularly sleeping in the     forest, who suffer a significantly higher number of clinical attacks. Thus, there is need to     target this high-risk group with new intervention based on long-lasting insecticidal     materials. Hammocks are extensively used by people working in the forest, therefore     long-lasting insecticidal hammocks (LLIH) could achieve a good individual protection.      The Investigators proposed to evaluate their effectiveness in a community-based trial,     comparing them to the standard vector control methods (insecticide-treated nets).   "
229197|NCT00853294|"     The objective of this open-label, randomized, two-period, crossover study was to evaluate the     oral bioavailability of the Mallinckrodt extended release test capsule formulation of     chlorpheniramine polistirex/hydrocodone polistirex compared to an equivalent oral dose of a     commercially available extended release oral suspension of chlorpheniramine     polistirex/hydrocodone polistirex (Tussionex® Pennkinetic® Extended Release Oral Suspension,     Celltech Pharmaceuticals, Inc.) in a test group of healthy subjects under fasting conditions.   "
229198|NCT00853307|"     This is an open-label, multicenter, single-arm, phase 2 study of MLN8237 in the treatment of     patients with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube,     or primary peritoneal carcinomas.   "
229199|NCT00853320|"     The objective of this open-label, randomized, two-period crossover study was to compare the     oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 15 mg to an     equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 15 mg, Roxane     Laboratories, Inc.) in a test group of healthy subjects under fasting conditions.   "
229200|NCT00853333|"     The investigators propose to evaluate the potential effect of sedation on pain perception in     two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's     brain activation using fMRI(objective).   "
229203|NCT00853385|"     This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background     methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence     of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background     methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended     to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function     that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also     included.   "
229204|NCT00853398|"     Overall study design:      A prospective, randomized, multi-center clinical studies comparing the minimal invasive and     the standard surgical total knee replacement technique (control) using the Genesis II total     knee system. The study will collect efficacy, safety and socio-economical data over 2 years.     An additional 5 years follow-up interval is optional. The objectives (short-term follow-up)     of the study are to:        1. Assess whether the improvement in Pain and Range of motion per Knee Society scoring          system and VAS score.        2. Assess whether there are any differences between the surgical techniques as regards          complication rate.        3. Assess whether the hospital stay and the rehabilitation time (Straight leg raise,          Active/passive ROM) of the patients differs between the two techniques.        4. Assess the x-ray mechanical alignment between the two techniques.      Attempts will be made to assess whether the collected peri-operative data (including incision     length, blood loss, wound appearance, hospital readmissions and operative time) differs     between the two surgical techniques.      The primary objectives (mid-term follow-up) of the study are to:        1. Improvement in Pain and Function per Knee Society Scoring system        2. Number and Extent of Radiographic Lucencies >2mm        3. Revision and knee-related adverse events        4. Improvement in Quality-of-life via the VAS score      5 investigational sites will participate and enroll a total of approximately 250 patients     over a 12 months period. Thus, each site will enroll 50 patients.   "
229205|NCT00853411|"     Asthma is a clinical syndrome that is well recognized by health care practitioners, yet     asthma pathogenesis still remains poorly understood. Asthma affects approximately 20 million     Americans, who suffer around 5,000 deaths annually. More than 70% of people with asthma also     suffer from allergies. Although many advances in understanding the pathophysiology of asthma     have been made in the past few decades, more studies are necessary to achieve a more thorough     understanding of asthma at the cellular and molecular level.      The majority of murine models suggest asthma and allergic responses involve activation of     Th2 cytokine pathways, including IL-4 and -13. Similarly in humans, several lines of evidence     support a large role for Th2 adaptive immunity. These include the large majority of asthmatic     patients with atopy; the measurement of increased amounts of Th2 cytokines, including IL-4     and IL-13 in the airways and sputum of mild asthma; and most recently, the observed efficacy     of anti-IgE therapy in allergic asthma. However, other data, including the large numbers of     subjects with atopy and no asthma, suggest Th2 adaptive responses are insufficient to explain     many aspects of asthma. Whether and how innate and adaptive immune pathways interact in human     asthma is not clear, with few studies beginning to address these interactions in vitro and in     vivo.      For this reason, the investigators of this study would like to prospectively enroll patients     with known asthma and follow them through an asthma exacerbation, while treating them with a     standardized protocol. Over six week's duration, the investigators would like to study     patients by collecting physiologic data such as spirometry, and biologic material in the form     of sputum, nasal scraping, venous blood, exhaled breath and sputum. It is our aim to fully     characterize the impact of the prostaglandin/cycloygenase/eicosanoid pathway as it relates to     asthma exacerbation and recovery.      Completion of this study in human asthma may provide new mechanistic insights into how     relationships between innate and adaptive immune responses influence the course of an asthma     exacerbation. The information obtained from this research and the corresponding studies may     lead to innovative medical therapies and insight into the role of the epithelium and its     interactions with both innate and adaptive immunity.   "
229275|NCT00854321|"     One centre follow-up study on safety and efficacy of treatment with rituximab among patients     with RA during 4 year period. Basic data is collected for the national register of     biologicals.   "
229206|NCT00853424|"     Diabetic eye disease remains a major cause of visual loss for individuals with type 1     diabetes, despite currently available treatments. Preliminary studies indicate that islet     cell transplantation, a new treatment for type 1 diabetes, may be beneficial for some people.     This study is designed to test the hypothesis that islet cell transplantation is more     effective than current medical therapy in preventing the progression of diabetic eye disease.   "
229207|NCT00853437|"     The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals     remains elusive to the clinician caring for critically ill pediatric patients even though a     large proportion of these children are known to have hemodynamic compromise as a result of     their illness. Current techniques used in adults to measure CO are not suitable for routine     use with pediatric patients. A new ultrasound dilution approach provides an opportunity to     measure cardiac output and blood volumes in pediatric patients. The main aim of this study is     to compare CO measured by the new method with the clinician's estimate and implied CO from     the measurement of the arteriovenous oxygen content difference.   "
229208|NCT00853450|"     The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on     bleeding time when taken together with low-dose ASA.   "
229209|NCT00853463|"     Brigham and Women's Hospital will coordinate a Quality Improvement Initiative at other     hospitals that focuses on whether physician notification prior to discharge of high risk VTE     patients will reduce the incidence of VTE after hospital discharge.   "
229210|NCT00853476|"     This study aims to compare skin reactivity results between morphine and histamine as a     positive control agents in intradermal skin test.   "
229211|NCT00853489|"     The purpose of our study is to evaluate the use of recombinant human bone morphogenetic     protein 2 (RhBMP-2) as compared to standard ICBG in the treatment of severe open tibia     fractures with a critical size bone defect (at least one centimeter in length compromising at     least 50% of the circumference of the bone).   "
229212|NCT00853502|"     Decreased bone strength is a common and serious medical problem present in many people with     anorexia nervosa. Men with anorexia nervosa have lower levels of gonadal steroids such as     testosterone. Low testosterone levels have been shown to result in low bone density.      We are investigating whether bone mineral density and bone microarchitecture are abnormal in     males with anorexia nervosa and whether supplementation with testosterone would improve both     bone mineral density and bone microarchitecture.   "
229213|NCT00853515|"     Vigorous fluid resuscitation is currently believed to play a key role in reducing     complications associated with acute pancreatitis. However, aggressive fluid replacement can     be associated with complications such as pulmonary fluid sequestration. The purpose of this     study is to evaluate alternative approaches to early fluid resuscitation for patients with     acute pancreatitis.   "
229214|NCT00853528|"     RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less     damage to normal tissue. It may also help patients with spinal metastases live more     comfortably.      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic     radiosurgery in treating patients with spinal metastases.   "
229215|NCT00853541|"     Heart failure (HF) is a major public health problem, which affects about 5 million     Americans.HF is when the heart muscle does not pump as much blood as the body needs. As a     result of this,the body has difficulties in keeping an optimal fluid status. The fluid status     of the body is regulated by both the heart and the kidneys. Due to the strong interaction     between the heart and the kidneys, heart failure can result in a slight decreased kidney     function as well.      It is known that people who primarily suffer from chronic kidney disease (CKD) have a higher     risk of developing arterial calcifications. Calcification of the arteries is caused by     deposits of calcium within the walls of the blood vessels. Calcifications of the arteries may     result in a loss of elasticity of the blood vessels. Recent research studies have shown that     people with CKD have stiffer blood vessels which in these people, is associated with a higher     chance of developing cardiovascular diseases.      However, it is not known whether a decrease in kidney function in people with HF results in     arterial calcification as well. In addition, it is not known whether this is also associated     with a higher risk of developing cardiovascular diseases (diseases of the heart and blood     vessels.) We are asking you to take part in this study because you have HF combined with some     decrease in your kidney function.      The purpose of this study is to see whether people with HF and a decrease in kidney function     do have a higher chance of developing arterial calcifications. We will do this by comparing     the results of the following; 1) several blood tests, 2) pictures taken of your heart by     echocardiogram and computed tomography (CT) scan, and 3) measurements of the elasticity of     your arteries. All of these tests are routinely used in clinical care. However, there have     not been any research studies that have compared these results to see how they relate to     arterial calcification in people with HF who have a decrease in kidney function.      We also want to see whether people with HF and a decreased kidney function are at a higher     risk of developing cardiovascular diseases. This study is being performed at Massachusetts     General Hospital (MGH), in Boston Massachusetts. We expect to enroll a total of 150 subjects     at MGH.   "
229216|NCT00853554|"     The objective of this open-label, randomized, two-period crossover study was to compare the     oral bioavailability of a Mallinckrodt test tablet formulation of hydromorphone 8 mg to an     equivalent oral dose of a commercially available hydromorphone tablet (DILAUDID® 8 mg, Knoll     Pharmaceutical Company) in a test group of healthy subjects under fasting conditions.   "
229217|NCT00853567|"     Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex     25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness     between 50 mg versus placebo, and between 25mg and placebo will be analyzed.   "
229218|NCT00853580|"     The specific aim of this study is to determine whether Lovastatin ™ significantly improves     visual spatial learning and/or sustained attention in children with NF1.      Secondary Aims:      To evaluate the effect of Lovastatin ™ on measures of executive function, behavior and     quality of life in children with NF1 and cognitive deficits.      To further evaluate the toxicity and tolerability of Lovastatin ™ in children with NF1 and     cognitive deficits.      Hypotheses      It is hypothesized that Lovastatin ™ will improve the visual spatial memory and/or attention     deficits in children with NF1. This is based on studies demonstrating that Lovastatin ™ has     significantly improved impairments in visual spatial memory and attention in the NF1 murine     model.      It is further expected that Lovastatin ™ will be safe and well tolerated over a 16-week     period.   "
229219|NCT00853593|"     This study is designed to show that a new lead, which paces the left bottom chamber (left     ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart     has been shown to potentially improve heart failure symptoms. The shape and size of this new     lead may make it a good choice for patients or physicians.   "
229220|NCT00853606|"     This open-label study is being conducted to evaluate the long-term safety, tolerability, and     efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400     subjects will be enrolled and treated with avanafil for up to 52 weeks.   "
249142|NCT01110746|"     The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and     Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy.   "
229221|NCT00853619|"     The goal of the Clinical Decision Support (CDS) Consortium research study is to assess,     define, demonstrate, and evaluate best practices for knowledge management (KM) and CDS in     healthcare information technology across multiple ambulatory care settings and electronic     health records (EHR) technology platforms.      There are seven specific research objectives focusing on two practical areas of     implementation for clinical decision support services: a) healthcare maintenance and     preventive care screening, and b) two chronic disease conditions: Coronary Artery Disease     (CAD), and Adult-onset Diabetes Mellitus (AODM). The research objectives are: 1) Knowledge     management lifecycle, 2) Knowledge specification, 3) Knowledge portal and repository, 4) CDS     knowledge content and public web services, 5) CDS Dashboard, 6)Evaluation, and 7)     Dissemination.   "
229222|NCT00853632|"     The purpose of the study is to demonstrate the long term safety and effectiveness of the     Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve     replacement with or without concomitant procedures requiring cardiopulmonary bypass.   "
229223|NCT00853645|"     Primary objective is to evaluate the safety and performance of the implanted S-ICD system. A     maximum of 10 subjects were to be enrolled and followed for one month to collect data on the     safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient     comfort will be assessed as will cosmetic outcome.   "
229224|NCT00853658|"     The study will evaluate the efficacy and safety of both aliskiren monotherapy and     aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity     and mortality in patients with chronic heart failure (NYHA Class II - IV.   "
229225|NCT00853671|"     The investigators propose a novel technique using dual source multidetector computed     tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is     obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be     devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and     coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary     plaque as well as assess the functional significance of a stenosis.   "
229250|NCT00853996|"     This phase II trial is studying how well acolbifene works in preventing cancer in     premenopausal women at high risk of breast cancer. Chemoprevention is the use of certain     drugs to keep cancer from forming. The use of acolbifene may stop cancer from growing or     coming back.   "
229251|NCT00854009|"     The purpose of this study is to evaluate the safety and tolerability of single doses of     BLI-489 administered intravenously in healthy Japanese male subjects, and how the drug is     absorbed and eliminated.   "
231055|NCT00876694|"     This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in     Japanese patients with moderate to severe COPD. Data from this study will be used for the     registration of indacaterol in Japan.   "
229226|NCT00853684|"     It is hypothesized that other anti-angiogenic agents such as endostar, may augment the effect     of chemotherapy regimens in CRC. Endostar, a recombinant human endostatin which expressed and     purified in E. coli, was approved by the SFDA for the treatment of non-small-cell lung cancer     in 2005. Ling et al. found that endostar suppressed the VEGF-stimulated proliferation,     migration, and tube formation of human umbilical vein endothelial cells (HUVECs) in vitro,     and the antiangiogenic effects of endostar were correlated with the VEGF-triggered signaling.     (Ling et al, 2007) A Chinese phase III clinical trial in advanced non-small-cell lung cancer,     endostar--a new angiogenesis inhibitor prolonged the overall survival, time to progression     and improved response rate. (Wang et al, 2005) Based on these results, the investigators     design this phase II clinical trial of oxaliplatin, capecitabine and endostar as first line     treatment, to evaluate whether endostar can bring survival benefits to patients with advanced     colorectal cancer.   "
229227|NCT00853697|"     Usually, the male hormone testosterone makes prostate cancer cells grow. Lowering     testosterone usually stops the growth of prostate cancer. However, after a period of time     without testosterone, prostate cancer cells learn to grow again.      You are able to join this trial because your prostate cancer is growing even though you have     very low levels of testosterone. Studies have shown that high doses of testosterone, in this     situation, can cause prostate cancer cells to stop growing.      The investigators did a study several years ago in which the investigators gave high doses of     testosterone to patients such as yourself. The investigators showed that giving testosterone     in this situation was safe. The investigators also showed that the investigators could, in     some cases, make the PSA go down using high-dose testosterone.      The investigators believe that they can improve this type of treatment by combining     testosterone with another drug called dutasteride. Dutasteride is another type of hormone. It     should make testosterone levels rise. The investigators believe that combination of     dutasteride and testosterone will be more a more powerful regimen against your cancer than     testosterone alone.   "
229228|NCT00853710|"     The aim of the study is to compare the diagnostic performances of a simple and rapid PSA     assay on whole blood to the standard plasma PSA assay.   "
229229|NCT00853723|"     This is a three month comparison trial of standard dose parathyroid hormone (PTH) (1-34) and     two different doses of Parathyroid Hormone-related Protein (PTHrP) (1-36). The investigators     want to to demonstrate that daily subcutaneous injection of PTHrP (1-36) in postmenopausal     women with osteoporosis stimulates bone formation to the same or greater degree than PTH     (1-34) but with less bone resorption.   "
229230|NCT00853736|"     The objective of this open-label, randomized, two-period crossover study was to compare the     oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an     equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 30 mg, Roxane     Laboratories, Inc.) in a test group of healthy subjects under fed conditions.   "
229231|NCT00853749|"     The primary purpose of this study is to evaluate the immune response to 13-valent     pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a     complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine     (PSV). This study is also intended to evaluate the safety of the 13vPnC.   "
229232|NCT00853762|"     This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063     (NCT00642902). The aim of this study is to monitor the safety and tolerability of atacicept     administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS).      This extension study consists of two parts. Part A will be double blind and Part B will be     open label. During Part A, subjects initially randomized to atacicept will continue to     receive the atacicept dose to which they have been randomized in study 28063 (ATAMS) once a     week subcutaneously (under the skin). Subjects randomized to placebo in ATAMS will receive     atacicept at 150 mg once a week subcutaneously during Part A. Once the results of ATAMS are     available and the atacicept dose with the best benefit / risk ratio has been identified, all     subjects will be switched to this dose and will continue the extension study open-label (Part     B). Throughout the study, subjects and investigators will remain blinded with respect to     initial and part A treatment allocation/dose.   "
229301|NCT00854659|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     three different strengths of an investigational product dosed twice a day over 7 days in     healthy subjects.   "
229233|NCT00853775|"     The purpose of this study is to determine whether lipoprotein(a), also called Lp(a), is a     risk factor for cardiovascular (heart) disease. Lipoproteins are tiny particles that     circulate in the blood. They contain cholesterol, fat, and protein in varying amounts     depending on the body's need. Higher levels of lipoproteins in the blood can cause an     increased risk of heart disease.      The investigators believe that by studying the Lp(a) lipoprotein in Caucasians and African     Americans, the investigators can assess for genetic variation factors related to     cardiovascular (heart) disease. The investigators will be looking at 100 African-American     families and 100 Caucasian families to confirm whether a higher Lp(a) level is an indicator     of a higher risk for heart disease.   "
229234|NCT00853788|"     The purpose of this study is to assess whether skin biopsy specimens from patients with     diffuse cutaneous systemic sclerosis (dcSSc) can be used as biomarkers (measures of activity     and type) of disease to predict response to various experimental treatments. There are     various experimental treatments being used in the treatment of slceroderma, but there is no     way to predict response to any given therapy. The investigators will use DNA microarray to     analyze the changes in gene expression in skin biopsies in response to various treatments.     Our hypothesis is that the investigators will see changes in gene expression in response to     various treatments that will give us insight into the cause of scleroderma. The investigators     predict that they will be able to use this information to predict which experimental     treatments will be beneficial to individual patients   "
229235|NCT00853801|"     An educational intervention in the General Medicine Clinic aimed at both primary care     providers (PCPs) and their patients with metabolic syndrome/pre-diabetes (MetSyn/PDM).     Improving PCPs ability to detect and manage MetSyn/PDM, as measured by the increased     incorporation of MetSyn/PDM into PCPs care plan, and increasing patients' awareness of     healthy lifestyle behaviors results in positive patient health behaviors and outcomes.   "
229278|NCT00854360|"     This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week,     multi-center, dose-range-finding study in male or female patients (12 years and older) with     SAR.   "
229236|NCT00853814|"     Increased access to highly reinforcing sedentary behaviors in the home such as TV and     computers are associated with overweight in youth. Reducing these behaviors reduces     overweight and prevents increases in overweight in youth who are at risk, likely by     increasing physical activity and/or reducing energy intake. Reducing access to highly     reinforcing sedentary activities frees-up time and youth must choose to reallocate their time     between engaging in other, less reinforcing sedentary activities or physical activity.     Neighborhood environments that provide easy access to reinforcing physical activities such as     those at parks may result in greater increases in physical activity when access to highly     reinforcing home sedentary behaviors is reduced. The investigators have found in 3 data sets     of youth ranging in age from 4 to 16 years that the proportion of park and recreation area to     residential area within ½ mile of the child's home parcel (park and recreation index)     independently predicted the physical activity of youth. The investigators also found that     increases in physical activity when access to sedentary behaviors were reduced for 3 weeks     was related to park area within ½ mile of the child's home. The aim of this study is to     decrease access to home sedentary behaviors for 4 months and determine if changes in physical     activity habits are related to access to parks and recreation areas in the neighborhood     environment. The investigators propose to study 128 sedentary overweight male and female     12-14 year-old youth recruited from parcels within Erie County, New York that have a high or     low park and recreation index. Groups will be matched on racial/ethnic distribution and     socioeconomic status. Subjects living at low and high park access parcels will then be     equally randomized to groups that reduce targeted sedentary behavior (TV, computer use) time     by 50% using TV Allowance devices placed on each TV/monitor in the home or a control group     that has the same experimental experiences including TV Allowance devices placed on each     TV/monitor, but programmed to not limit access to targeted sedentary behavior. Subjects will     wear both accelerometers and wrist-watch-type global positioning systems to determine changes     in the duration and intensity of physical activity in various parcel types, including parks.     The investigators hypothesize differential responses in physical activity and the utilization     of parks for physical activity. The group of youth that live at parcels with high access to     parks and that incur a 50% reduction in sedentary behavior will have greater increases in     physical activity, number of visits to parks and will accrue greater physical activity at     parks than youth in the other 3 treatment groups. The investigators hypothesize that the     alterations in physical activity will be mediated by parent modeling of physical activity and     individual differences in the motivation to be physically active. The investigators     hypothesize that there will be a main effect of reduction in access to sedentary behaviors on     energy and fat intake and percent overweight.   "
229237|NCT00853827|"     The study will assess the change in coronary atherosclerotic disease as determined by     intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to     standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the     pre-hypertensive range.   "
229238|NCT00853840|"     The objective of this study was to estimate the effects of a single dose of vardenafil on the     blood pressure (BP) in subjects receiving maraviroc (MVC) (dosed to steady-state) and to     assess the safety and tolerability of MVC in subjects receiving a single dose of vardenafil.   "
229239|NCT00853853|"     This study will compare hemorrhoid surgery by comparing a sutureless heating device with the     old standard hemorrhoid surgery. Patients will be followed closely for wound healing and     satisfaction.      Hypothesis: The sutureless device will be less painful for the patient and easier for the     surgeon to perform.   "
229240|NCT00853866|"     The hypothesis of the study is that combination of reboxetine/tDCS is more effective in     enhancing motor functions of daily life (assessed by the Jebsen Taylor test) as compared to     reboxetine and tDCS alone. The protocol is designed as a within-subject, block randomized     placebo-controlled double-blind crossover study.   "
229241|NCT00853879|"     This study is being conducted to assess the impact of folate and L-methylfolate on the     progression of Parkinson's. The investigators are specifically looking for the effect of     these nutritional supplements in Parkinson's patients who have an antibody that effects their     body's utilization of folate. An antibody is a protein produced by the body's immune system     to recognize foreign substances. Normally, people do not have an antibody that prevents     folate from working properly in the brain but it appears that some people may have such an     antibody. Folate is an important vitamin that takes part in many critical cell functions so     an antibody that prevented it from entering the brain properly could cause or worsen certain     neurological disorders like Parkinson's. The results of this preliminary study will help     determine whether it is reasonable to proceed with further study of any of these supplements     for the treatment of Parkinson's. Patients interested in participating will have a blood test     to see if they have folate antibodies. Patients with the antibody will be eligible to further     participate in the study. The investigators will measure the effects of folate and     L-methylfolate on Parkinson's disease by measuring the change in your Parkinson's disease     symptoms over three months of treatment. The investigators will also be looking at the blood     of some individuals who do not have Parkinson's. This is called a control group and will     allow us to compare how common the folate antibody is in the general population compared with     the Parkinson's population.   "
229242|NCT00853892|"     The objective of this open-label, randomized, two-period, crossover study was to evaluate the     oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of     oxycodone 40 mg compared to an equivalent oral dose of a commercially available     controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.) in a test group     of healthy subjects under fasting conditions.   "
249397|NCT01120444|"     The purpose of this study is to compare the effects of bolus delivery of insulin when     delivered either intradermally (in the skin) or subcutaneously (under the skin) in diabetics.   "
229244|NCT00853918|"     This is a national physician mail survey examining primary care practice patterns. The     experimental component of the study (the clinical trial) is a randomized trial of different     monetary incentive forms and amounts for physicians invited to participate in the study. Only     non-VA physicians will be included in this part of the study. (VA physicians are not allowed     to receive monetary incentives.) Physicians will be randomized to receive one of four     incentives: $20 cash, $50 cash, a $50 check, or a $100 check. The main outcome measure is the     response rate.   "
229245|NCT00853931|"     This is an exploratory study in which all eligible subjects are given Panitumumab according     to the dose and schedule approved by Health Canada. The purpose of this research study is to     determine whether the presence of certain biomarkers (substances measurable in blood, normal     cells or tumour tissue) are associated with an increased or decreased chance of benefit from     panitumumab.   "
229246|NCT00853944|"     Islet transplantation requires a large number of islets required to achieve insulin     independence and the function of the transplanted islets progressively declines over time.     Evidence from animal studies and human islets in culture suggests that increasing GLP-1     levels could help with both of these problems. This study is designed to test this hypothesis     using sitagliptin in a randomized clinical trial.   "
229247|NCT00853957|"     The purpose of the study is to evaluate the BP-lowering efficacy of the combination of     aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African     American patients with Stage II hypertension.   "
229248|NCT00853970|"     Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery   "
229249|NCT00853983|"     The aim of this study is to show how the body absorbs, metabolises and excretes the drug     [14C]AZD0530. As for all clinical trials, safety and tolerability of the drug will be     evaluated.   "
229252|NCT00854022|"     This study will further the understanding of the genetic events leading to the development of     RCC; explore the genetic basis for genetic instability and how it affects cancer risk; and     eventually provide a means of identifying a subgroup of individuals who are most likely to     develop RCC. Such individuals may then be targeted for intervention programs such as     chemoprevention or dietary modification.   "
229253|NCT00854035|"     This Phase III clinical trial will examine the efficacy, safety, and tolerability of the     addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes Mellitus who have     inadequate glycemic control on diet/exercise therapy and insulin monotherapy.   "
229254|NCT00854048|"     Evaluate pulse oximeters with children after cardiopulmonary by-pass under low Oxygen     conditions.   "
229255|NCT00854061|"     Study of T-PRED(TM) Compared to Pred Forte(R)   "
229256|NCT00854074|"     The primary goal of this study is to validate the design of the ElectroCore RMS-1100     Resolution Motility System™ and the ability to safely place a stimulation electrode in the     epidural space of the spine in a post-operative subject, and to evaluate the subject's     ability to tolerate stimulation for up to 48 hours. The secondary goal is to confirm that the     electrical signal being delivered via this electrode shows evidence of effectiveness in     improving the functional GI motility in subjects experiencing post-operative paralytic ileus   "
229257|NCT00854087|"     Current treatment of chronic liver disease relies upon removing the primary insult to the     liver (e.g., alcohol) or treating the underlying viral infection (HBV, HCV, etc.). However,     in the case of hepatitis C, a significant number of individuals will not clear the virus with     current approved standard antiviral therapy, leaving them no options to manage their hepatic     fibrosis, which can progress to cirrhosis and ultimately hepatocellular carcinoma (HCC).      Fuzheng Huayu has been used in numerous studies in China and has been found to have a     satisfactory prophylaxis effect on the chronic liver injury and formed liver fibrosis in rats     and humans. In addition, it enhances the degradation of liver fibrosis and protects     hepatocytes from injury and death, manifesting as decreasing of ALT and AST, and enhancement     of albumin level. In addition, preliminary studies indicate that the Fuzheng Huayu has a good     safety and tolerability profile with promising efficacy.      The number of patients failing Interferon based therapy (i.e. not achieving SVR) is     increasing. There are no approved standard of care treatment options for this population nor     for patients who are intolerant or unwilling to receive Interferon; thus they are at higher     risk for the progression of fibrosis. Moreover, there are no approved therapies to treat     hepatic fibrosis, but basic research is exploring the pathophysiological mechanisms. Fuzheng     Huayu is easy to administer, with a good safety and efficacy profile against fibrosis.     Therefore, the investigators propose to further study the safety and efficacy profile of     Fuzheng Huayu in a randomized, placebo-controlled, double blind study in Chronic Hepatitis C     patients with hepatic fibrosis who have failed prior anti-HCV therapy or are intolerant or     refuse Interferon based therapy.      The primary objective of this study is to establish the safety and efficacy of Fuzheng Huayu     treatment in chronic hepatitis C subjects who have failed prior anti-HCV therapy or cannot     receive or refused Interferon based therapy in improving liver fibrosis.   "
229258|NCT00854100|"     This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on     therapy to standard antidepressants in patients who did not respond to previous     antidepressant therapy.   "
229259|NCT00854113|"     This study evaluated the safety, tolerability and pharmacokinetics of single or multiple     doses of EGT0001474.   "
229260|NCT00854126|"     This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and     pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with     incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or     failed to respond to at least one prior regimen or for which there is no standard therapy.   "
229261|NCT00854139|"     The primary objective is to cure multiple myeloma with less toxic allogeneic bone marrow     transplantation while inducing renal allograft tolerance through mixed chimerism in patients     with end stage renal failure and multiple myeloma   "
229262|NCT00854152|"     This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and     pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with     incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or     failed to respond to at least one prior regimen or for which there is no standard therapy.   "
229326|NCT00854984|"     A feasibility pilot trial of the self-help, Cognitive behavioural therapy based Living     Life to the Full Materials for use by patients with diabetes type 2 and / or coronary heart     disease.   "
229263|NCT00854165|"     Survival after cadaveric lung transplantation in recipients depended on ventilation support     prior to transplantation has been reported to have relative high surgical mortality and     morbidity rate. The objectives of this study were to describe the short-term outcomes of     bilateral sequential lung transplantation under extracorporeal membrane oxygenation (ECMO)     support in a consecutive series of patients who depended on noninvasive and invasive     ventilation support preoperatively .   "
229264|NCT00854178|"     The purpose of this study is to evaluate if the anesthetics propofol and isoflurane can     damage DNA, induce apoptosis, change expression of genes related to apoptosis and DNA repair     and change cytokines profile in patients submitted to elective surgery.   "
229265|NCT00854191|"     In a RCT, mechanical simulator practice enhances clinical ERCP performance of novice trainees     during the first 3 months of usual ERCP training.   "
229266|NCT00854204|"     The purpose of this study is to compare the bioavailability (the degree to which a drug     becomes available in the body after administration) of 3 different pharmaceutical     preparations of a combination of two drugs, TMC114 and TMC41629. There will be 1 single oral     intake (intake by mouth) of each of the 3 preparations. The study will also investigate the     safety of use and the potential side effects of TMC114 and TMC41629, and determine the     circulating levels of both compounds in your blood over time (pharmacokinetics), after a     single intake.   "
229267|NCT00854217|"     Several studies have highlighted the cardioprotective effects of acute normovolemic     hemodilution during cardiac surgery. The aim of our study is to show that an increase in     endogenous erythropoietin (EPO) might explain the cardioprotective effects of acute     normovolemic hemodilution against ischemia-reperfusion phenomena.   "
229289|NCT00854503|"     Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia,     promotes the development of coronary heart disease. Secondary dyslipidemia is often     associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase     inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading     to a significant reduction of cardiovascular risk. More recently, revisions to guidelines     have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring     the administration of higher dose of statin. However, it is unclear whether high dose statin     therapy could affect glycemic control in diabetic patients. Moreover, data regarding the     effects of statins on insulin-resistance and endothelial function are controversial.   "
229268|NCT00854230|"     This is a randomized double blind clinical trial to test the effect of Naltrexone on HIV     infected heavy drinkers. The study will select 40 HIV positive patients who meet criteria for     heavy drinking. Treatments include Naltrexone (25-100mg)and placebo. Patients will be     treated, followed up, and assessed for a duration of 12 weeks.      The investigators associated hypotheses Hypothesis 1: Naltrexone will reduce the frequency of     heavy drinking. Hypothesis 2: Naltrexone will lead to maintenance or improvement in CD4     lymphocyte count and decreased HIV RNA levels.      Hypothesis 3: Naltrexone will lead to a reduction in sexual risk behaviors. Hypothesis 4:     Naltrexone will lead to improved adherence to HAART. Hypothesis 5 (Exploratory): Naltrexone     will be well-tolerated with minimal side effects and patients will exhibit good treatment     retention.   "
229269|NCT00854243|"     The purpose of this study is to evaluate the role of musculoskeletal ultrasound and power     Doppler in early therapy monitoring of rheumatoid arthritis patients.   "
229270|NCT00854256|"     The aim of the study is to investigate pressure lowering effect of two surgical methods     canaloplasty and trabeculectomy in patients with open angle glaucoma, in which under local     pressure lowering therapy the progression of the disease could not be stopped, and thus a     pressure lowering surgical intervention is necessary. The risks in the postoperative course     in Canaloplasty in the literature as lower than for the trabeculectomy with mitomycin-C.     Conversely, large glaucoma centers questioning the effectiveness of permanent pressure     lowering of canaloplasty. Precisely this question is investigated in the study.   "
229271|NCT00854269|"     Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of     the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women     worldwide dying of cervical cancer each year. Human papilloma viruses (HPV) have been     consistently implicated in causing cervical cancer especially those high-risk types (HPV     16,18,31,45) have been strongly associated with cervical cancer. Around 50-80 % of women are     infected by HPV within their whole lives. However, only 1% of HPV-infected women have     cervical cancer eventually. Seventy and 91% of HPV infection could be cleaned up by host     immune responses within 1 and 2 years later. It shows that host immunity plays an important     role in the progression, persistence, or regression of HPV infection.      There are two main defense lines in the host immunity including innate immunity and adoptive     immunity. Adoptive immunity plays more important roles in the defense of HPV infections than     innate immunity. The adoptive immunity could be further divided into humoral immunity and     cell-mediated immunity. Humoral immunity regulated by Th2 helper T lymphocytes to generate     memory B cells to produce antibody which provide the protective function to HPV infection.     Cell-mediated immunity regulated by Th1 helper T lymphocytes to induce antigen-specific     cytotoxic T cells which could kill the HPV-infected cells. Although there are many researches     focused on the immunity to HPV infection, there is no conclusion about the relationship     between humoral and cell-mediated immunities on HPV infection and roles of humoral and     cell-mediated immunities in the prognosis of HPV-infected population and cervical cancer     patients.      Our research team has focused on the establishment of platforms on cell-mediated immunity to     HPV infection and on the correlation of cell-mediated immunity and prognosis of HPV-infected     population and cervical cancer patients for years. In order to survey the host immunity to     HPV infection more comprehensively, we propose this 3-year proposal. First, we would like to     set up the platforms to survey the humoral immunity to HPV infection in normal population and     patients with CIN lesion or cervical cancer. Second, we would to elucidate the correlation     between humoral immunity and status and clinico-pathologic items of HPV-infected populations.     Third, we would like to survey if the humoral immunity correlate with the prognosis of     patients with cervical lesions. Fourth, we would like to elucidate the correlation betweenHLA     haplotype and humoral immunity in HPV-infected populations. Our research results will have a     more comprehensive overview in the host immunity to HPV infection and its related diseases.     It could provide more information in the prevention and treatment of HPV infection in the     future.   "
229272|NCT00854282|"     Cancer is the leading cause of mortality in our country, and ovarian cancer becomes a more     and more important disease gradually in the field of gynecologic malignancies. According to     the statistics of the Department of Health, the incidence of ovarian cancer increased in     recent years and the mortality rate was the highest among all gynecologic malignancies in     Taiwan. Early diagnosis for ovarian cancer is difficult due to the lack of obvious and     specific initial symptoms. Therefore, it is usually at advanced stage when the diagnosis is     confirmed. The prognostic parameters for ovarian cancer include tumor stage, histological     subtype and grade, residual tumor after surgical intervention and the response to     chemotherapy. However, the possible mechanism of ovarian cancer is still not clear now, which     has considerable influence on the management and prognosis of the patients.      Malignancy is considered as a multi-factorial disease, and the influence of immunologic     mechanism on progression and prognosis of cancer is more and more important. The natural     CD25+CD4+ regulatory T cells actively suppress pathologic and physiological immune response,     contributing to the maintenance of immunological self-tolerance and immune homeostasis. The     development and function of regulatory T cells depend on the expression of the transcription     factor forkhead box P3 (FOXP3). The mechanisms of suppression are still not known well.     Whatever the mechanisms of suppression are, it is necessary to control the magnitude of     regulatory T cells-mediated suppression for the benefit of the host because too much     suppression might lead to immunosuppression and render the host susceptible to infection and     cancer.      We will collect the tumor tissue, ascites and peripheral blood during operation. Through this     research we will set up the immunological profiles in the changes of lymphocytes, humoral     immunity and cell-mediated immunity in ovarian cancer patients. The kinetic changes and     associations between regulatory T cells and the severity and progression of disease will also     be evaluated. Therefore, the role of regulatory T cells would be defined in the patients with     ovarian cancer. We will also correlate the regulatory T cells with the clinical prognosis of     ovarian cancer patients. Finally, we will try to find an efficient therapeutic strategy for     the cancer patients.   "
229273|NCT00854295|"     The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile     Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.   "
229274|NCT00854308|"     This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily     evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib +     placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will     be randomized in a 1:1 ratio to one of the two treatment arms.   "
229276|NCT00854334|"     Rationale: Obesity is an increasing childhood epidemic in Canada. Obstructive sleep apnea     (OSA) is a complication of obesity which causes cardiovascular disease, reduced quality of     life, and premature death. While the complex interactions between obesity and OSA are not     entirely clear, we hypothesize that these conditions may compound each other by:        1. decreasing physical activity and total energy expenditure by reducing both non-exercise          physical pursuits (NEAT- non-exercise activity thermogenesis) and purposeful physical          activity.        2. alterations in the secretion of appetite-controlling hormones, which may lead to          increases in energy intake.      Objective: To determine whether the presence of both obesity and OSA in children is     associated with a decrease in physical activity and alterations in appetite-regulating     hormones greater than those seen in either condition alone or compared to controls.      Methods: Comparison of children 10-17 years with obesity and OSA, obesity alone, OSA alone     and neither condition, for the following outcomes: (1) NEAT (kcal/day) (2) Physical activity     behavior, appetite regulating hormone profile and self-report appetite assessment.      Unique Aspects: This study combines expertise in sleep medicine, exercise physiology and     obesity. Conclusions from this study will better characterize this high-risk clinical     population so that innovative strategies targeting improvements in lifestyle behaviors can be     developed.   "
229277|NCT00854347|"     Hyperglycemia is very common among critically ill patients, even in the absence of diagnosed     diabetes or pre-diabetes.      We aimed to determine the prevalence of occult glucose metabolism abnormalities in a general     intensive care unit (ICU) and hypothesized that hyperglycemia severity, as reflected by     insulin requirements for maintenance of normoglycemia, could be used as a tool to identify     high risk patients.   "
229279|NCT00854373|"     Marcelle Cedars, M.D., Victor Fujimoto, M.D., Mitch Rosen, M.D., Heather Huddleston, M.D.,     Paolo Rinaudo, M.D., Anthony Dobson, M.D., and Shehua Shen, M.D. from the UCSF Department of     Obstetrics and Gynecology and Reproductive Sciences are conducting a study to learn about     ovarian stimulation and oocyte maturation to improve fertilization, embryo quality,     implantation and clinical pregnancy rates in patients undergoing in vitro fertilization     (IVF). Two hormones, follicle stimulating hormone and human chorionic gonadotropin (FSH/hCG)     will be compared to the standard one hormone, hCG, for the ovulation trigger.      Over the past two decades, the success rate of assisted reproductive technology (ART) has     dramatically increased. This increase has largely been attributed to improvements in the     laboratory conditions and improvements in ovarian stimulation protocols (those medications     used to increase the number of eggs maturing each cycle). Less work has been done on     different ways to cause the final maturation of the eggs and the release of the egg from the     ovary. The investigators propose to change the final injection prior to the egg retrieval     (the ovulation trigger) so that it looks more like what happens in a normal menstrual cycle,     where two hormones (both luteinizing hormone (LH) and FSH) increase. The investigators want     to find out if this will improve egg quality and increase chances for pregnancy.   "
229280|NCT00854386|"     The objective of this study is to compare the effects of two intraoperative fluid regimens -     restrictive versus liberal (standard)- on postoperative outcomes (e.g. cardiopulmonary     complications, morbidity, mortality and duration of hospitalization) in lung resections via     Video-assisted thoracic surgery (VATS).   "
229281|NCT00854399|"     Ovarian cancer is the first mortality rate of gynecologic malignancies. The incidence of     ovarian cancer increased in recent 10 years and it has become the ninth cause of malignancies     in the women in Taiwan. From the above-mentioned data, ovarian cancer indeed is a disease     that should be respected, however, there were only few of research work focusing on it in     Taiwan. Despite the widespread use of aggressive cytoreductive surgery and the introduction     of chemotherapy regimens, the overall survival has changed little over the last two decades.     The basic problem in treating epithelial ovarian cancer is that once it has spread beyond the     ovary, it is exceedingly difficult to control and ultimately to cure. More than 70% of     ovarian cancer patients were advanced stage when diagnosed. To study the mechanisms of     carcinogenesis, progression, and metastasis of ovarian cancer will help us understand this     disease and develop new treatment strategies for ovarian cancer in the future.      We have established an ascites-generating intraperitoneal tumor cell line-WF3 in the mouse     model in our previous two-year project of NSC grant (grant number (NSC90-2314-B-002-457 and     NSC91-2341-B-002-315). Our group found that, mesothelin, this molecule is highly related with     the carcinogenesis, tumor progression and tumor metastasis in our animal model and human     cancer tissues. To further evaluate the role of mesothelin in ovarian cancer and elucidate     the potential of mesothelin as a target antigen for immunotherapy,   "
229282|NCT00854412|"     High levels of mannose-binding lectin (MBL), an activator of a part of the immune system     called the complement system, have been associated with increased mortality and risk of early     signs of kidney damage in patients with type 2 diabetes. The effect of weight loss and     changes in insulin resistance on MBL levels have been poorly elucidated.      This study includes 36 nondiabetic obese subjects, who will receive a very low- calorie diet     (VLCD) of 800 kcal/day for 8 weeks.      Fasting blood samples will be obtained at baseline and after 8 weeks of VLCD and     concentrations of MBL, glucose and insulin will be measured. Insulin resistance is assessed     using the HOMA-IR method.   "
229283|NCT00854425|"     The purpose of this study is to evaluate the efficacy and tolerability of L-asparaginase     monotherapy as salvage treatment in patients with NK/T cell lymphoma   "
229284|NCT00854438|"     Thesis: Is drug-induced anticholinergic activity additive resulting in a total     anticholinergic load causing harmful side effects in old, fragile patients? Is it possible to     reduce the anticholinergic load by multidisciplinary medical review including a pharmacist     and a physician? The effects of the medical reviews are measured by cognitive tests (MMS and     CERADS word lists), a measure of mouth dryness, serum levels of anticholinergic activity,     activity of daily living and neuropsychiatric symptoms.      Design: A randomized, controlled, single blinded interventional study in Norwegian nursing     homes.   "
229375|NCT00855621|"     The purpose of this study is to identify factors predicting good results in patients treated     with deep brain stimulation for Parkinson's disease. The study includes a comparison of two     surgical methods used to provide this therapy.   "
229285|NCT00854451|"     The aims of this study are (1) to evaluate the prevalence rate of PM of CYP2C19 in our     country; (2) to evaluate the efficacy of dual therapy with different dose of omeprazole and     amoxicillin; (3) to judge the relationship of genotype of CYP2C19 and the eradication rate of     dual therapy in the peptic ulcer patients; (4) to try to find out a predictor of success of     dual therapy and an optimal dose of dual therapy as first-line and rescue anti-Helicobacter     pylori regimen.   "
229286|NCT00854464|"     1. To investigate the relationship between arsenic methylation enzymes (AS3MT, PNP,GSTO1,          and GSTO2) genetic polymorphism and UC risk.        2. To explore the relationship between cigarettes metabolites (NNK, NNAL, HBA, NNAL-Gluc,          O6-Methylguanine, and N7-Methylguanine) and UC risk.        3. To examine the relationship between cigarette metabolic enzymes (CYP2A6, CYP2A13, and          UGT2B7) genetic polymorphism and UC risk.        4. To elucidate the relationship between DNA repair enzymes (MGMT, XPD, XRCC1, and XRCC3)          gene polymorphism and 8-OHdG or between DNA repair enzymes and UC risk.        5. To examine relationship between COX-2 (-1195G/A、-765G/C 和8473C/T), IL-6, IL-8, and TNF-α          gene polymorphism and 8-OHdG or between COX-2, IL-6, IL-8, and TNF-α gene polymorphism          and UC risk.        6. To examine the risk factors of the environment-environment, gene-environment, and          gene-gene interaction on the risk of UC.   "
229287|NCT00854477|"     The purpose of this study is to evaluate the pharmacokinetics (PK) of adjuvant capecitabine     in patients who have undergone proximal pancreatico-duodenectomy.   "
229288|NCT00854490|"     The purpose of this study is to evaluate the long-term clinical significance of     small-intestinal mucosal injuries in chronic NSAIDs-users.   "
229290|NCT00854516|"     To assess the safety of a new compression device applied to patients with an ankle brachial     pressure index (ABPI) 0,5 - 0,8 who are treated for two weeks in daily routine practice.     Several perfusion assessments will investigate safety under reduced compression therapy.   "
229291|NCT00854529|"     Trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery     creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.      A rather common adverse event of the surgery is increasing vascularity of the conjunctiva     overlying the bleb. This leads to adherence of the conjunctiva to the sclera and fibrosis and     finally failure of the bleb (and of the surgery) this study intends to demonstrate that post     operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and     ultimately, bleb failure.   "
229292|NCT00854542|"     Hypothesis 1. Telepsychiatry consultations will be acceptable and well-received by depressed     Chinese Americans and by their primary care clinicians.      Hypothesis 2. Depressed Chinese Americans in remote primary care clinics receiving T-CSCT     will have improved outcomes compared to patients who receive Usual Care by primary care     physicians.   "
229293|NCT00854555|"     The ATLET study will assess the effect of manual or robotic body-weight supported locomotor     training of patients with stable motor incomplete spinal cord injury (SCI) on gait and     overall ADL function as well as on estimated health care costs.   "
229294|NCT00854568|"     The aim of this study is to compare CHOP versus CEOP-induced cardiotoxicity in patients with     aggressive B-cell lymphoma. The hypothesis is epirubicin is associated with less     cardiotoxicity without compromising the efficacy.   "
229295|NCT00854581|"     RATIONALE: Human T-cell lymphotropic virus type 1 can cause cancer. Zidovudine is an     antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving     zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune     system and slow down or keep the cancer cell from growing.      PURPOSE: This clinical trial is studying how well giving zidovudine together with interferon     alfa-2b and PEG-interferon alfa-2b works in treating patients with human T-cell lymphotropic     virus type 1-associated adult T-cell leukemia/lymphoma.   "
229296|NCT00854594|"     The investigators' study focuses on improving the care of diabetes, a complex chronic     illness, by providing important insights into interprofessional training and its potential     role in fostering the necessary interdisciplinary management needed for chronic conditions     and in addressing the gap between best practice and actual care provided.   "
229297|NCT00854607|"     The purpose of this study is to evaluate the relationship between fungal biomarker levels     during anti-fungal therapy and the success of treatment for fungal infection. The primary     hypothesis is that over the initial two weeks of anti-fungal therapy, fungal biomarkers from     participants with invasive aspergillosis (IA) will be lower for those with a successful     clinical outcome compared to those with a failed clinical outcome.   "
229298|NCT00854620|"     Determine time-to-progression (TTP) for an escalating dose schedule for subjects with     progressive metastatic renal cell carcinoma treated with sorafenib   "
229299|NCT00854633|"     This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the     incidence of all nosocomial infections in prematurely-born infants.   "
229300|NCT00854646|"     This is an open-label, Phase I study to determine the highest amount of the study drug, ON     01910.Na, that can be safety given to patients with high risk myelodysplastic syndromes (MDS)     or refractory leukemias. Patients will receive ON 01910.Na (at a starting dose of 650 mg/m2)     intravenously by 3-day continuous infusion once every 2 weeks. Successive courses will use     longer infusion times and/or higher doses of the drug until toxicity, effectiveness, or     ineffectiveness is recognized. In addition, the amount of drug in the blood will be measured,     any antitumor activity will be documented, and the biological effect of ON 01910.Na on     cell-cycle pathways will be evaluated in peripheral blood mononuclear cells.   "
229302|NCT00854672|"     The aim of this study is to examine exercise capacity, muscle strength and fatigue in     sarcoidosis. In this longitudinal study the changes in prevalence of exercise intolerance,     reduced muscle strength and fatigue will be established in a two-year follow-up. Also the     relation between these physical impairments in time and other clinical parameters, such as     QOL, will be established.   "
229303|NCT00854685|"     The purpose of this clinical trial is to establish what dose level and dosing frequency is     optimal in the treatment of rheumatoid arthritis patients with ART621.   "
229304|NCT00854698|"     The real impact of the existence of an aortic valve mismatch after aortic valve replacement     in various studies conducted so far is a source of controversy. There is currently no     long-term impact of the aortic valve mismatch on the reversal of left ventricular remodeling     and its impact functional.To evaluate these effects of aortic valve mismatch on abilities to     the effort, the quality of life and the regression of left ventricular hypertrophy long term     after a aortic valve replacement, conducting a new study is fundamental. This study is even     more essential in patients with a young life expectancy theoretical long and physical     activity.Our study aims to determine whether the existence of an aortic valve mismatch has an     influence on: The functional capacity to the effort by measuring the maximum oxygen     consumption during a stress test (VO2 max) The reversal of left ventricular remodeling     (cardiac ultrasound doppler), diastolic dysfunction (cardiac ultrasound and Doppler     measurement Brain Natriuretic Peptide (BNP). This study will analyse these data in patients     who received youth a VAN by mechanical aortic valve prosthesis.   "
229305|NCT00854711|"     Reperfusion of ischemic myocardium, termed ischemia/reperfusion during the treatment of MI     may result in paradoxical myocardial injury compromising myocardial salvage and left     ventricular functional recovery. Nitric oxide (NO) modulates many of the processes     contributing to ischemia-reperfusion injury (IR)and inhaled NO (iNO) has been shown to     decease infarct size in animal models of IR. iNO has been studied in various clinical     settings and has shown promise im modulating the detrimental effects of IR. Clinical toxicity     potentially associated with the use of iNO was of no apparent concern in these studies.     Although controlled trials of iNO therapy in humans with acute MI have not been published,     anecdotal experience indicates a beneficial impact of iNO on the hemodynamic course of     patients with right ventricular MI. iNO is widely used to treat neonatal hypoxemia and acute     pulmonary hypertension. iNO has been studied at this dose in various clinical settings and     side effects related to its use at such doses are extremely uncommon. The effect of iNO on IR     injury in patients with acute ST-segment elevation MI is unknown. The investigator intend to     perform a prospective, randomized, placebo-controlled, clinical trial of iNO in patients with     acute MI undergoing primary percutaneous intervention to determine whether this form of     therapy can decrease infarct size and improve clinical outcomes.   "
229306|NCT00854724|"     This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a     major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment     with this compound will reduce alcohol self-administration in a simulated natural settings     laboratory.   "
229307|NCT00854737|"     The goal of the proposed clinical trial is to assess the effect of oral cytidine and omega-3     fatty acids (O3FA) on bipolar disorder symptoms. This study is a 4-month, randomized,     parallel-group, double-blind, placebo-controlled pilot study of a combination of cytidine and     omega-3 fatty acids in 90 recently ill subjects with bipolar disorder. During the 16 week     period of the study, subjects are assigned to one of three groups: 1) omega-3 fatty acids +     cytidine supplementation, 2) omega-3 fatty acids supplementation alone, and 3) placebo     supplementation.   "
229308|NCT00854750|"     The investigators principal hypothesis is that INO and optic neuritis are objective,     quantitative, and reproducible models for corroborating the hypothesis that changes in core     body temperature are associated with the reversible and stereotypic decay in axonal     conduction and that ACTHAR can serve to prevent such changes. The application of ocular motor     and optic nerve measures appears to constitute a useful paradigm to detect and monitor     responses to therapeutic strategies that stabilize nerve cell membranes in response to     temperature induced decay in axonal conduction mechanisms, with implications on activities of     daily life that are dependent upon vision (reading, driving, walking, work performance).   "
229309|NCT00854763|"     We will conduct an open label, non-comparative, observational study to evaluate the efficacy,     safety and tolerability of Olmesartan therapy in Taiwan patients with essential hypertension,     and the primary objective is the change in the 24-hour mean systolic blood pressure from     baseline to the day after post-treatment week-12 visit according to the ambulatory blood     pressure monitoring.   "
229310|NCT00854776|"     Studies showed that combined use of clopidogrel and aspirin had a 25 % reduction of risk on     myocardial infarction and stroke in patients who undergone percutaneous coronary intervention     (PCI) when compared with use of aspirin alone. However, major GI bleeding rose in combined     group than aspirin group. Use of proton pump inhibitor (PPI) which diminishes gastric acid     secretion effectively reduces aspirin or clopidogrel associated ulcer or/and ulcer bleeding     in general population and high risk patients. The investigator hypothesis is whether use of     PPI can reduce ulcer and ulcer complication in patients taking both clopidogrel and aspirin.   "
229311|NCT00854789|"     The objectives of this study are the following:        1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75)          in node-negative breast cancer patients.        2. To determine the optimal dose of the immunoadjuvant, GM-CSF, necessary to elicit an in          vivo cellular immune response to the peptide vaccine yet limit toxicity.        3. To determine the optimal inoculation schedule to elicit an in vivo cellular immune          response to the peptide vaccine.        4. To correlate the efficiency of eliciting an in vivo cellular immune response to the          peptide vaccine with the degree of HER2/neu expression in the patient's tumor.   "
229312|NCT00854802|"     The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin     triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis     C genotype 1 patients.   "
229313|NCT00854815|"     The purpose is to quantify the effect of irrigation during laparoscopic appendectomy for     perforated appendicitis.   "
229376|NCT00855634|"     PaMeViTUM is a mono-centric prospective randomized controlled trial that compares different     operating procedures in patients with pancreatic cancer and minimal metastatic disease or     venous infiltration.   "
229314|NCT00854828|"     This is a multicenter study evaluating the effectiveness of nonoperative and operative     treatments. The investigators wish to identify important clinical and radiographic     determinants of outcomes in the management of adults with symptomatic lumbar scoliosis     (ASLS).      Note: Enrollment was complete July 2014. NIAMS funding ended 2/28/17. We continue to follow     enrolled subjects while we seek additional funding to follow all subjects through 8 years.   "
229315|NCT00854841|"     Research Hypothesis:      Treatment with dasatinib 100 mg QD is superior to imatinib 600 mg QD in terms of complete     cytogenetic response (CCyR) in chronic phase (CP) Philadelphia chromosome-positive (Ph+)     Chronic Myeloid Leukemia (CML) subjects who are imatinib failures or who have achieved only a     suboptimal response after 3-18 months (12-77 weeks) of therapy with imatinib 400 mg.      Primary Objective:      The primary objective of this study is to compare the rate of CCyR of dasatinib (100mg QD) to     high-dose imatinib (600 mg QD) therapy at 6 months after randomization in CP Ph+ CML subjects     who are imatinib failures or who have achieved only a suboptimal response after 3 - 18 months     of imatinib monotherapy at 400 mg/day.   "
229316|NCT00854854|"     The purpose of this study is to determine efficacy of NKCell combined FOLFOX-4 chemotherapy     in gastric cancer   "
229317|NCT00854867|"     The purpose of this study is to demonstrate the safety of giving Whole Brain Radiotherapy     (WBRT) together with intrathecal liposomal cytarabine (DepoCyte®) for patients with     leptomeningeal metastases. The study will compare the safety of giving DepoCyte at the same     time as WBRT with giving the drug after WBRT is complete.   "
229318|NCT00854880|"     The objective of this trial is to evaluate the efficacy and safety of PDC-339 in the     treatment of acute erosive gastritis, using placebo as the comparator.   "
229319|NCT00854893|"     The purpose of this study is to test the effect of transcranial direct current stimulation     over the motor cortex of the language dominant hemisphere on language learning in healthy     subjects and stroke patients with aphasia. We hypothesize that anodal stimulation enhances     the learning of action words compared to sham and cathodal stimulation.   "
229366|NCT00855504|"     Infections affecting the mother during pregnancy may produce alterations in the normal     cytokine and hormone-regulated gestation, which could result in preeclampsia, preterm labor,     premature rupture of membranes, and preterm birth. Therefore, pregnant women with periodontal     disease may show an alteration in the cytokine levels which may cause preeclampsia in them.   "
229367|NCT00855517|"     The purpose of this study is to evaluate IOP response to experimental dose of Latanoprost-     PPDS in subjects with ocular hypertension or open-angle glaucoma.   "
233398|NCT00902356|"     The primary objective of this study is to determine the safety and tolerability of AMG 167     following a single dose subcutaneous (SC) or intravenous (IV) administration in healthy men     and postmenopausal women.   "
229320|NCT00854906|"     The purpose of the research is to determine if putting fluorescein onto the eye (most common     test done for dry eye syndrome) is an accurate way to measure dry eye symptoms. The     investigators can avoid placing any foreign substance into the eye by using a manual     keratometer. Therefore, the investigators want to compare the measurements of tear breakup     time using fluorescein with using a novel method, a manual keratometer and then compare these     measurements to a validated dry eye symptoms questionnaire. All qualifying patients who were     scheduled in the Jones Eye Institute Clinics for a complete eye exam were offered information     about the study and invited to participate. Participants were recruited from February 29,     2009 to April 14, 2009.Participants who did not meet the study protocol's inclusion and     exclusion criteria were not included the study or study data analysis. All subjects eyes were     measured for KTBUT and FTBUT.   "
229321|NCT00854919|"     Objective: Although atypical antipsychotic drugs (AAPDs) have been found effective in the     augmentation of serotonin reuptake inhibitors (SRIs) for treatment-resistant     obsessive-compulsive disorder (OCD) in short terms trials, there are few data on the     effectiveness and safety of these agents in clinical settings over the long term.      Method: Subjects (n=46) who responded to selective SRIs (SSRIs) in an initial 12-week trial     were continued on SRI-monotherapy plus cognitive-behavioral therapy (CBT) for one year.     Subjects (n=44) who failed to respond to SSRIs were randomly assigned to one of 3 AAPDs such     as risperidone and were consecutively treated using SSRI+AAPD combined with CBT for a year.   "
229322|NCT00854932|"     In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific     and currently available tests have poor positive and negative predictive values. The     investigators hypothesize that procalcitonin (PCT) has a reliable negative predictive values     to allow a reduction in duration of empiric antibiotic therapy in suspected neonatal     early-onset sepsis with unchanged outcome. This study is designed as a multi-center,     prospective, randomized intervention trial. The duration of antibiotic therapy in the     standard group is based on the attending physician's assessment of the probability of     infection during hospitalisation. In the PCT group, if infection is considered to be unlikely     or possible, antibiotic therapy is discontinued when two consecutive PCT values are within     the normal range.   "
229323|NCT00854945|"     The primary objective of this study is to evaluate the efficacy and safety of ON 01910.Na     Concentrate when it is administered as an intravenous continuous infusion (IVCI) over 72     hours once every 2 weeks in a broad population of MDS patients. Rationale for this study is     based on the activity observed in another study with ON 01910.Na in patients with refractory     anemia with excess blasts (RAEB) 1 and 2 MDS. This study will examine ON 01910.Na in a     broader population of MDS and AML patients. This phase I/II study will establish the Maximum     Tolerated Dose (MTD) starting with a dose of 800 mg/m2 per day administered over 24 hours for     2 consecutive days as a continuous intravenous infusion, once a week for 3 weeks of a 4-week     cycle and examine the efficacy and safety profile at the MTD.   "
229324|NCT00854958|"     Oral allergy syndrome is a type of food allergy which mainly affects people with springtime     hay fever. It is caused by a cross-reaction, between antibodies to pollens, usually birch     tree pollen, and allergens in many different plant foods. It is characterised by symptoms of     itching and/or swelling in the mouth and/or throat when eating certain fruits vegetables and     nuts. Many of the allergens causing OAS are destroyed by heat, making allergy testing using     traditional allergen extracts unreliable. Prick testing or challenging with fresh foods is     more reliable, but time consuming, inconvenient and largely unavailable. Pilot study results     suggest the characteristic symptoms and foods involved in OAS allow accurate diagnosis using     clinical history alone, which forms the basis for the hypothesis of this proposal that OAS     can be diagnosed accurately by use of a validated questionnaire alone. The diagnostic     questionnaire (PFSDQ), revised from the results of the pilot study, will be tested against     two reference test methods, the gold standard of oral food challenge, and the 'platinum     standard' of diagnosis made by a medical expert based on history, skin prick testing and oral     food challenge. This is not an epidemiological study but with no published studies on OAS in     a UK population, this study will also provide some information on the prevalence of OAS in     those with springtime hayfever in the UK.   "
229325|NCT00854971|"     The purpose of this study is to determine efficacy of NKCell in colorectal cancer   "
229327|NCT00854997|"     Objective: Untreated OSA is associated with three fold risk of fetal and non-fetal     cardiovascular events than control subjects in the long-term follow up. However, the     prevalence rate and impact of OSA in patients with acute myocardial infarction (AMI) was not     clear so far. The conflicts of studies come from variable period of AMI, heart function at     enrollment, techniques used to diagnose OSA, time to revascularization, and target endpoint.     Therefore, this project aimed to study the patients of first-time, Killip I-II, and post     primary percutaneous coronary intervention (PCI) AMI in both and chronic phase to achieve     four goals:      Aim 1. To determine the prevalence rate of OSA in patients with first-time AMI The acute     phase of AMI was defined as within 14 days of the onset of AMI and the chronic phase was     defined as > 14 days of onset. Eligible patients were screened with polysomnography within     5th to 7th days and 6th months of AMI to determine the prevalence rate of OSA in the AMI.     Patients who had AHI more than 15/hr were considered as suffering from OSA.      Aim 2. To identify the clinical characteristics and risk factors in AMI patients associated     with OSA Patients were followed up at clinics for five years. The baseline demographics of     patients with or without OSA were compared to determine the factors associated with OSA in     AMI patients.      Aim 3. To study the impact of OSA on the prognosis of AMI patients after revascularizaton The     primary endpoint was mortality rate and cardiac events. The secondary endpoint was left     ventricular function and variables related to cardiovascular disease (CVD) and metabolic     syndrome. The impact of OSA on AMI was determined by comparing primary and secondary endpoint     between AMI patients with and without OSA.      Aim 4. To identify the clinical and molecular factors attributing to AMI in OSA patients     Factors attributing to AMI in OSA patients were determined by comparing the clinical data and     mRNA expression of angiogenesis and other related genes in OSA patients with the acute phase     of AMI and patients without major CVD.   "
229328|NCT00855010|"     Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on     pancreatic fat content and bone turnover markers.   "
229329|NCT00855023|"     This study evaluates the the anatomic factors of the knee that may predispose to ACL injury.   "
229330|NCT00855036|"     The objective of this study is to evaluate the outcomes of children who have sustained blunt     renal injury and to evaluate our current bed rest protocol. The variables of concern are     readmission, operation, subsequent hypertension and clearance of hematuria. The specific aim     of the study is to prospectively collect the clinical data of these children to validate our     hospital management and to define the natural history of these lesions.   "
229331|NCT00855049|"     This study is being done to determine the systemic absorption of nasally inhaled     acetaminophen (Tylenol®) versus orally ingested acetaminophen by comparing the serum drug     concentrations of the two groups obtained at various times after study drug administration.   "
229332|NCT00855062|"     Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline,     an antibiotic, in the treatment of Human immunodeficiency virus (HIV)-associated cognitive     impairment in Uganda.      Study Design: Treatment, 24-week Randomized, Placebo-Controlled, Double-Blind Phase with     Optional 24-week Open Label Phase for Subjects with a cluster of differentiation 4 (CD4)     Count in the 251-350 Range        -  Arm 1: Minocycline 100 mg orally every 12 hours (50 subjects)        -  Arm 2: Matching placebo orally every 12 hours (50 subjects)      Primary Objective:      · To examine whether minocycline treatment will improve cognitive performance after 24 weeks     compared to baseline      Secondary Objectives:        -  To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in          individuals with HIV-associated cognitive impairment        -  To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in          individuals with HIV-associated cognitive impairment        -  To examine whether minocycline treatment for 24 weeks improves functional impairment   "
229333|NCT00855075|"     The purpose of this study is to correlate the cerebral state index obtained from a cerebral     state monitor with the Richmond Agitation-Sedation Scale assessment performed on sedated and     mechanically ventilated intensive care patients.   "
229334|NCT00855088|"     This study is being conducted to look at how the body handles the drugs darunavir and     etravirine. It will measure the amount of darunavir and etravirine in blood, semen, and in     the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the     reproductive and intestinal tracts. It is believed that the presence of this drug in these     areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person     to another. The study will take samples of blood, semen and rectal mucosal tissue to measure     drug levels. This study will also collect information on side effects.   "
229335|NCT00855101|"     This study is to assess the plasma concentration-time profile of voriconazole in adults     receiving 7-day intravenous treatment and 6.5-day oral treatment. This study is also to     assess the safety profile of voriconazole during the treatment period.   "
229336|NCT00855114|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well everolimus works in treating women with     breast cancer that can be removed by surgery.   "
229337|NCT00855127|"     The purpose of this study is to find new blood and urine tests that detect acute kidney     injury earlier than our current blood tests in patients receiving a liver transplant.   "
229338|NCT00855140|"     Insomnia is a common and disabling condition associated with psychiatric and medical     comorbidities and often persists despite currently available treatments. Acupuncture has been     reported to benefit individuals with insomnia and can decrease hyperarousal. This blinded RCT     will investigate the impact of a standardized acupuncture protocol on insomnia, daytime     symptoms, and hyperarousal.   "
229339|NCT00855153|"     The purpose of this pilot study is to begin the examination of the feasibility of using     Gradual Virtual Reality Exposure Therapy and D-Cycloserine (DCS) in the management of     posttraumatic psychological symptoms in burned OIF/OEF military combatants.      The purpose of a feasibility study is to determine if there is clinical utility in this     proposed treatment and to establish effective and safe treatment procedures. Given current     literature, the following hypotheses are generated:      Hypothesis 1: Virtual Reality Exposure and D-Cycloserine medication (VRE + DCS learning pill)     will result in clinically meaningful PTSD symptom reduction.        1. SMs will attain scores that are lower than initial measures for symptoms of PTSD        2. By the completion of VRE, Ss will attain scores in the sub-clinical range for measures          of clinical depression Hypothesis 2: SMs will report greater life satisfaction following          completion of VR+DCS treatment, as measured by scores on the Quality of Life Inventory          (QOLI) when compared to pre-treatment scores   "
229340|NCT00855166|"     This study is being carried out to see if dapagliflozin in addition to metformin decreases     body weight and if so, how it compares with metformin alone.   "
229341|NCT00855179|"     To assess the efficacy and tolerability of Antistax film coated tablets in patients with     chronic venous insufficiency (CVI, CEAP Classification: Clinical class 3 and 4a).   "
229342|NCT00855192|"     Approximately 20% of pregnant women experience depression. Untreated depression during     pregnancy is linked to decreased prenatal care, difficulties in the pregnancy, poorer     outcomes for the baby, and developmental, language, and behaviour problems in the older     child.      While medication can often offer relief, pregnant women suffering with depression are often     reluctant to take medications that may affect the unborn baby. There is little research about     the effectiveness of other treatments such as support groups.      The investigators project will provide relaxation groups for pregnant women with anxiety and     depression. The group will provide a chance to get support from other pregnant women. Two     health care specialists will provide information about anxiety and depression. They will also     teach the skills for women to manage their symptoms. Women will be asked to complete a few     questionnaires to evaluate their symptoms before, during, and after they join the group. They     will also be asked to evaluate how the group met their needs.   "
229343|NCT00855205|"     Sarcoidosis is a inflammatory disease affecting many parts of the body, especially the lungs.     While most patients do well, there is a group of patients who require continuous doses of     prednisone or other drugs. The current study will determine the role of Rituximab as new     agent for patients with refractory disease.   "
229344|NCT00855218|"     This study will look at whether our drug (sorafenib) in combination with chemotherapy     delivered directly into your tumor using beads (DC Bead) will slow the progression of the     disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing     the adverse effects that normally occur with chemotherapy.   "
229345|NCT00855231|"     The ACUTE CT trial is designed to test whether the assessment of chest structures by     high-resolution multislice computed tomography (CT) provides equivalent diagnostic accuracy     for patient with acute chest pain or other potential cardiac symptoms as compared to a     standard of care evaluation.   "
229446|NCT00855920|"     This purpose of this clinical research was to determine the efficacy and safety of an     experimental drug called Rilonacept in participants with an acute gout attack. Participants     participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin     alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.   "
229346|NCT00855244|"     Life for long-term bone marrow transplant patients is complicated by endocrine late effects     including growth hormone (GH) deficiency, thyroid hormone deficiency and sex steroid     deficiency. Recently, studies have also identified problems with metabolic syndrome in adult     bone marrow transplant (BMT) survivors. Metabolic syndrome has been identified as a     constellation of insulin resistance, truncal obesity and high lipid levels (dyslipidemia) and     is associated with an increased risk of type 2 diabetes and cardiovascular disease. Thus the     early identification of metabolic syndrome is important. To date, studies have not identified     how young an age metabolic syndrome begins in BMT survivors.      The investigators' study will consist of two aims:        1. Evaluation of children who have survived BMT for growth hormone deficiency, abnormal          lipid metabolism, hypothyroidism and gonadal dysgenesis. The investigators will utilize          growth hormone stimulation testing, sex steroid levels, an oral glucose tolerance test          (OGTT) and fasting lipid profile to evaluate for concomitant endocrinopathy, prediabetes          and impaired glucose tolerance in a cohort of BMT survivors.        2. Cross-sectional study of peripheral and hepatic insulin sensitivity in children          surviving BMT using a hyperinsulinemic euglycemic clamp and the stable isotope 6,6 [2H2]          glucose. These aims will provide pilot data to power the first definitive study of          insulin resistance in childhood BMT survivors.   "
229347|NCT00855257|"     The investigators' work proposes to evaluate the effectiveness of the Acid Nicotinique     (Niaspan®), only molecule currently marketed, ready to raise the plasmatic levels of HDL-c.     This effectiveness will be tested among patients having presented recently an acute coronary     syndrome. The effectiveness of the molecule will be appreciated versus placebo after     randomization.      The technique of evaluation of this effectiveness will be the analysis of the vasodilatation     endothelial-dependent measured on the level huméral (by echography high resolution).      The awaited result is an improvement of 2% in value absolute of this vasodilatation between     the initial test and the end of study for the patients receiving the acid nicotinic versus     those receiving the placebo (3 months of treatment after inclusion). The calculation of the     sample necessary to achieve this goal envisages 70 patients led at the end of the study,     divided into two groups of treatment (acid nicotinic or Placebo).      Such a result if it were obtained would be higher than that found in studies evaluating the     effect on the vasomotricity endothelial statins or inhibitors of the enzyme of conversion.   "
229348|NCT00855270|"     This study is designed to test the hypothesis that a single Hydrocortisone intra venous     injection within 6 hours post-trauma facilitates physiological recovery thereby preventing     the development of Post Traumatic Stress Disorder (PTSD) in the months following the event.     In the absence of such treatment (i.e., under placebo conditions), we hypothesize that a     greater proportion of persons would develop PTSD (i.e., fail to recover from acute effects).   "
229349|NCT00855283|"     DWE (difficulty with evacuation) is a common and an important quality of life issue after     spinal cord injury. Not only is the management DWE time-consuming and unpleasant, but the     results are often suboptimal in terms of complications such as incontinence and impaction.     Bowel care regimens after spinal cord injury have not changed in any significant fashion in     many years. The usual strategies for attaining bowel evacuation involve dietary manipulation     (e.g., high fiber diets and hydration), thrice weekly laxative administration (senna and     cascara) and thrice weekly anorectal instillation of cathartics (enemas and suppositories).     Bowel care can be quite time consuming (greater than 2 hours in many instances) and may also     require extensive nursing care. Finally, incomplete evacuation could contribute to fecal     incontinence that has significant morbidity in these patients.      In preliminary studies performed at the JJPVAMC, IV, IM, and subcutaneous injection of     neostigmine combined with glycopyrrolate were demonstrated to be highly effective to promote     bowel evacuation in the SCI population. In an effort to provide a more realistic     administration of this procedure, we propose to test the intranasal spray injection of     neostigmine and glycopyrrolate for safety and efficacy.   "
229377|NCT00855647|"     To demonstrate that a hypo-fractionated course of radiotherapy (ie. an accelerated     radiotherapy course where fewer but larger doses of radiotherapy are given) is both safe and     effective in the treatment of low-risk localized prostate cancer.   "
229378|NCT00855660|"     Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days,     on bone metabolism.   "
229379|NCT00855673|"     The study tests the use of a portable mechanical compression device (FM220, Flowmedic, USA)     for the treatment of claudication and peripheral arterial disease.      Major endpoints are improved exercise tolerance and relevant blood pressure ratios   "
229350|NCT00855296|"     Thrombin is the most potent activator of platelets, and platelet activation is a hallmark of     thrombosis. Coronary artery disease (CAD) is the major cause of mortality and morbidity in     the United States and other industrialized countries, and thrombotic sequelae are the key     cause of death in diabetes. The accumulation of thrombin at sites of vascular injury provides     one of the major mechanisms of recruiting platelets into a hemostatic plug. Thrombin works by     activation of the G protein-coupled protease activated receptors PAR1 and PAR4 on human     platelets to initiate signaling cascades leading to increases in [Ca]i, secretion of     autocrine activators, trafficking of adhesion molecules to the plasma membrane, and shape     change, which all promote platelet aggregation. The thrombin receptors work in a progressive     manner, with PAR1 activated at low thrombin concentrations, and PAR4 recruited at higher     thrombin concentrations. As direct thrombin inhibitors become widely used in clinical     practice, it is important to assess their effects on vascular function. Our hypothesis is     that PAR1 and PAR4 do not signal through the same G protein pathways, and that PAR4 is not a     strong platelet agonist. To investigate this hypothesis, the investigators will study the G     protein pathways downstream of PAR4, and assess ex-vivo platelet responsiveness to thrombin,     PAR1, and PAR4 agonist peptides, both in normal human subjects, and along the stages of     pathology, from patients with stable angina as well as unstable angina who are undergoing     angioplasty. Similarly, the investigators will examine platelet function in patients with     metabolic syndrome as well as diabetes, along the continuum from insulin resistance to     full-blown disease. These studies will provide deeper insight into the G protein pathways     used by PARs. They will elucidate the contribution of PAR receptors to normal platelet     function as well as the abnormal platelet activation in thrombotic states. The long term goal     is to understand the implications for PAR receptors as therapeutic targets for anti-platelet     therapies that may carry less bleeding risk.   "
229351|NCT00855309|"     RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in     patients with neutropenia.      PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is     comparing two doses of acyclovir in preventing herpes simplex virus infection in patients     with neutropenia.   "
229352|NCT00855322|"     The purpose of this study is to determine whether exercise is beneficial for people with     rheumatoid arthritis(RA) taking antiTNFalpha medication   "
248361|NCT01106404|"     The purpose of the study is to gather clinical information on subjects' experiences with and     without the use of the new feature of the RestoreSensor implantable neurostimulator (INS).   "
229353|NCT00855335|"     The purpose of this study is to study how changes in the body during pregnancy influence the     blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat     taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and     ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study     will examine how these drugs are absorbed in the body, how they are distributed within the     body and how they are removed from the body over time. Any pregnant woman who is currently     receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for     HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll.     Patients must be willing to remain on study medication during the course of their pregnancy,     and 12 weeks postpartum. The information collected may help answer questions about how to     best prescribe these three drugs for pregnant women.   "
229354|NCT00855348|"     The purpose of this study is to collect blood specimens and clinical data from screening     guideline eligible individuals designated by their physician to receive a screening     colonoscopy, and to evaluate the performance of a colorectal cancer-specific DNA methylation     biomarker for detection of colorectal cancer in this cohort. Based on the outcome of the     colonoscopy, polypectomy, biopsy and surgical tissue histopathology, the clinical utility of     Septin 9 as colorectal cancer screening test will be evaluated.   "
229355|NCT00855361|"     The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, and the     safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in     newborns and pre-term infants.   "
229356|NCT00855374|"     Thrombin is the most potent activator of platelets, and platelet activation is a hallmark of     thrombosis. Coronary artery disease (CAD) is the major cause of mortality and morbidity in     the United States and other industrialized countries, and thrombotic sequelae are the key     cause of death in diabetes. The accumulation of thrombin at sites of vascular injury provides     one of the major mechanisms of recruiting platelets into a hemostatic plug. Thrombin works by     activation of the G protein-coupled protease activated receptors PAR1 and PAR4 on human     platelets to initiate signaling cascades leading to increases in [Ca]i, secretion of     autocrine activators, trafficking of adhesion molecules to the plasma membrane, and shape     change, which all promote platelet aggregation. The thrombin receptors work in a progressive     manner, with PAR1 activated at low thrombin concentrations, and PAR4 recruited at higher     thrombin concentrations. As direct thrombin inhibitors become widely used in clinical     practice, it is important to assess their effects on vascular function. Our hypothesis is     that PAR1 and PAR4 do not signal through the same G protein pathways, and that PAR4 is not a     strong platelet agonist. To investigate this hypothesis, the investigators will study the G     protein pathways downstream of PAR4, and assess ex-vivo platelet responsiveness to thrombin,     PAR1, and PAR4 agonist peptides, both in normal human subjects, and along the stages of     pathology, from patients with stable angina as well as unstable angina who are undergoing     angioplasty. Similarly, the investigators will examine platelet function in patients with     metabolic syndrome as well as diabetes, along the continuum from insulin resistance to     full-blown disease. These studies will provide deeper insight into the G protein pathways     used by PARs. They will elucidate the contribution of PAR receptors to normal platelet     function as well as the abnormal platelet activation in thrombotic states. The long term goal     is to understand the implications for PAR receptors as therapeutic targets for anti-platelet     therapies that may carry less bleeding risk.   "
229357|NCT00855387|"     The purpose of this study is to prospectively assess the impact of surgical quality on the     overall cost of major surgical procedures using the incidence and severity of complications     as surrogate markers of quality.   "
229358|NCT00855400|"     The purpose of this clinical trial is to asses the feasibility and the security of the     intraspinal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic     Lateral Sclerosis patients.   "
229359|NCT00855413|"     Purpose: This is a pilot study to evaluate HIV viremia and persistence in acutely HIV     infected antiretroviral naïve patients treated with Darunavir/ritonavir and Etravirine      Participants: 20 participants, age 18 and older, HIV infected, antiretroviral naïve patients      Procedures (methods): ARV treatment with Darunavir/ritonavir and Etravirine,      Optional studies:      Genital secretion samples, Cerebrospinal fluid samples, Leukapheresis, Endoscopy/colonoscopy   "
229360|NCT00855426|"     Nondisplaced hip fractures may be radiographically occult and require MRI or single photon     emission CT bone scintigraphy for accurate diagnosis. Both examinations are expensive and are     not readily available in many hospitals. Ultrasound (US) examination is relatively     inexpensive and preliminary data had demonstrated its efficacy in detecting occult fractures     in other sites. Our objective is to evaluate US examination as a screening tool for occult     hip fractures in posttraumatic painful hips in the elderly.   "
229361|NCT00855439|"     This study will look at whether or not the medication exenatide improves signs and symptoms     of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate     diabetic peripheral neuropathy.   "
229380|NCT00855686|"     The purpose of this exploratory study is to determine whether memantine can provide benefits     on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy     Bodies.   "
249460|NCT01121133|"     This is an open-label, single or multiple center study to determine the interaction of     rifampin with navitoclax (ABT-263) in approximately 12 subjects with cancer.   "
229362|NCT00855452|"     The present protocol is a phase 2 study designed to investigate the potential application of     allogeneic cell-mediated immunotherapy in metastatic solid tumors, similarly to the well     established graft versus leukemia (GVL) effects, in patients with metastatic solid tumors     resistant to conventional treatment modalities. Patients will be eligible to participate in a     treatment program based on systemic administration of mismatched lymphocytes activated in     vitro with rIL-2 (LAK) followed by rIL-2 inoculation in vivo. This treatment is aiming to     induce an anti-tumor effect mediated by the efficient killing activity of the rIL-2 activated     cells. Prior to cell infusion patients will receive the conditioning treatment with low dose     Cyclophosphamide (Cyc) or Fludarabine with 2 injections of low dose alpha interferon. Cell     therapy will be combined with specific anti-tumor monoclonal antibodies if available for the     specific disease. Further activation of the anti-tumor activity of alloreactive donor T cells     and natural killer (NK) cells will be accomplished by in vivo inoculation of rIL-2, aiming     for enhancing the anti-cancer potential of donor-derived effectors cells. Patients will     receive one - three cycles of cell therapy, as long as there are no signs of Graft- versus -     Host - disease (GVHD) and the malignant disease is controlled.   "
229363|NCT00855465|"     The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521,     given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension     (CTEPH).   "
229364|NCT00855478|"     To assess the safety and effecacy of the Cypher stent ™ & Cypher Select ™ in the normal use     of medical practices, within the labeled indications.   "
229365|NCT00855491|"     The purpose of this study what to evaluate if axial myopia might influence the development of     PCO.   "
229368|NCT00855530|"     Primary objective:      - To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with     major depressive disorder (MDD).      Secondary objective:      - To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for     pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with     MDD, and to evaluate the efficacy of amibegron in patients with MDD.   "
229369|NCT00855543|"     The purpose of this study is to better understand (1) if phospholipase A2 producing     microorganisms and cytokines (IL-1, IL-4, IL-6, IL-10, and IL-13) are associated with     premature labor (2) if pregnant teens are more likely to have phospholipase A2 producing     bacteria than a pregnant adults and (3) if there is a difference in the cytokines between     pregnant teens and adults.We hypothesize that phospholipase producing microorganisms may     trigger the onset of premature labor. The following are hypothesized: (a) The microorganism     cultured should show high activities of phospholipase A2 (b) The cervical length measurement     predictive value should correspond to the gestation age at term (c) Vaginal flora of teen     will be more susceptible to colonization with higher phospholipase A2 producing bacteria than     that of an adult (d) The maternal genotype contribution to the concentration of IL-1, IL-4,     IL-6, IL-10, IL-13, and TNF-alpha during the first trimester of pregnancy in teens is     different in the production of inflammatory cytokines and modulators(e) The maternal genotype     of teens therefore influences the production of phospholipase A2 and causes an increase in     preterm delivery.   "
229370|NCT00855556|"     The goal of the study is to develop and organize an effort to identify genes that determine     an individual's risk for developing Parkinson's disease (PD).        1. To ascertain, study and establish a repository of DNA samples that will allow for the          identification of known and yet-to-be-identified genetic markers associated with the          development of PD.        2. To create a database with clinical, genetic (HLA, genome screen) and medical history          information that will facilitate the search for PD susceptibility genes.        3. To provide a centralized DNA repository to allow for targeted studies of genetic factors          contributing to the onset, heterogeneity and progression of PD.        4. To evaluate opportunities to extend the results of research to develop methods of risk          prediction, prevention and therapy for PD.   "
229371|NCT00855569|"     The rationale underlying the study is that donor site bleeding is common and often     problematic when presenting to the burn surgeon or staff. Frequently, gauze wound dressings     are not sufficiently hemostatic to control a donor site bleed thereby leading to     administration of vasoconstrictive agents and repeated application of wound     dressing/pressure. The hemostatic textile Stasilon™ has proven superior to gauze in reducing     bleeding from anesthetized pigs undergoing standardized surgically-induced trauma. Also,     observational case reports have noted cessation of bleeding in a limited number of human     patients with difficult to control bleeds.   "
229372|NCT00855582|"     Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and     5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and     symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of     BPH.   "
229373|NCT00855595|"     Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15%     gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole     1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at     total of twelve weeks to determine the rapidity of improvement, and the length of time to     reach 25%, 50% and 75% clearing compared to baseline.   "
229374|NCT00855608|"     Direct intravitreal administration of medication is the preferred method of treatment for     uveitis and retinal vascular disorders. The eye is a self contained organ relatively isolated     from the systemic circulation by the tight blood retinal barrier. Effective intraocular drug     levels can be achieved with a much smaller amount of medication if injected intravitreally     and this also results in minimal systemic exposure to the patient. Preliminary studies have     shown that adalimumab may have a positive role in the management of uveitis in humans and can     be an effective treatment intravitreally in animal models. No data has been published yet on     intravitreal use of adalimumab in human subjects.   "
229381|NCT00855699|"     Once someone becomes dependent on alcohol (alcoholic), the risks of complications from     alcohol withdrawal when they stop drinking grow. These can include a life−threatening fit or     delirium tremens (see things, become frightened). To prevent such complications, people take     medication such as benzodiazepines (e.g., valium or librium) in reducing doses for about a     week; this is called detoxification or 'detox.' In the UK effective alcohol treatment exists     but little is known about what is the best detox medication. Alternative drugs to     benzodiazepines appear to protect the brain from the toxicity of alcohol withdrawal and to     reduce the likelihood of drinking again. This study will examine the feasibility of comparing     medication regimens for alcohol detox for the first time in primary care. It will include a     standard detox regimen (librium over 8 days) alone and together with a drug, acamprosate,     that has been shown to reduce toxicity of alcohol withdrawal in preclinical models and is     used after detox to help people remain sober. It will focus on the practicalities of doing     such a study as well as assessing how people feel (withdrawal symptoms) and do (drinking     during first month).   "
229382|NCT00855712|"     The purpose of the study is to compare survival of both patients and newly transplanted     hearts following heart transplantation among patients who were transplanted with donated     hearts preserved on ice and those who were transplanted with donated hearts using the Organ     Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused     beating state. The study also compares the number of rejection episodes, heart related     adverse events, ICU time, and ventilation time between the two groups. The study is     considered a success if survival in the OCS group was not inferior to the ice group.   "
229383|NCT00855725|"     The goal of this study is to determine whether there are unique markers on neuroimaging that     are associated with depression in epilepsy.   "
229384|NCT00855738|"     Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs     (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and     topiramate, used as first-choice combination therapy (bitherapy) in patients with focal     epilepsy.   "
229447|NCT00855933|"     This is a randomized, controlled, examiner-blind, parallel group, four week clinical study     comparing brushing plus flossing to brushing alone in healthy adults with mild-to-moderate     gingivitis.   "
229385|NCT00848796|"     Two heparin brands have been in the market in Canada for several years. Heparin Leo from Leo     Pharma and Hepalean from Organon. The former is standardized by B.P (British pharmacopeia)     while the latter is standardized by U.S.P (United states pharmacopeia). Previous studies have     shown Heparin Leo to have roughly a 10% less efficacy then Hepalean. It has also been     demonstrated that more protamine is required to reverse Heparin Leo. It is the investigators'     intention to study the post-operative effects of the two brands of heparin and whether one of     the two causes less bleeding after bypass surgery.   "
229386|NCT00848809|"     This study is an observational analysis that monitors the effect of different dialysis     methods on vancomycin levels when patients are critically ill. No changes are made to therapy     based on levels, but levels are checked more frequently than normal. The primary dialysis     methods being studied are SLED (slow-low efficiency daily) dialysis and intermittent     hemodialysis. Vancomycin is the only medication being evaluated in this study. This study     will provide detailed information on how to dose vancomycin in patients that are on dialysis     in the intensive care unit.   "
229387|NCT00848822|"     The purpose of this project is to look at how sleep affects glucose values in children with     Type 1 Diabetes Mellitus. It will also evaluate if glucose is affected by times of day due to     the body's own internal rhythm also known as the circadian rhythm.   "
229388|NCT00848835|"     To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads     over 5 years.   "
229389|NCT00848848|"     The study will evaluate the safety, tolerability and immunogenicity of different doses and     types of Influenza Vaccine in healthy elderly subjects.   "
229390|NCT00848861|"     -to determine if propofol sedation leads to shorter recovery times compared to traditional     sedation using midazolam plus meperidine   "
229391|NCT00848874|"     Abstract: In Phase I, we designed and tested a Portable Visual Guidance System (PVGS), which     combines a PDA - for user guidance - and an Internet website - for linking the user to an     educational support team. Use of the PVGS 1) significantly improved the in vivo social     pragmatics of students diagnosed with Aspergers Syndrome/Higher Functioning Autism (AS/HFA);     2) revealed additional ways of improving social pragmatics; and 3) improved activity     management in scheduling and vocational tasks.      In Phase II, we will focus on social pragmatics and two closely related skills: feelings     management and assignment management. We aim to:        1. Replicate Phase I success in the most educational setting for AS/HFA high school aged          students: mainstream school inclusion classes.        2. Replicate Phase I findings more efficiently, with a less highly trained, on-site          coaching staff and with more distant (non-site) expert supervision of that staff.        3. Contrast the outcomes of the curriculum with a diagnosis-matched wait-list control          group.        4. Develop and implement software that will enable on-site staff to create and modify          individualized guidance and monitoring screens as needs arise.        5. Design a commercially attractive package of software, video training, video-conferenced          support, and manuals.        6. Complete the translation of the SymTrend website and all the above tools into Spanish.      Significance: Successful completion of Phase II will:        1. Provide a very effective and comprehensive system for teaching social pragmatics and          related management skills to AS/HFA persons in an inclusion context.        2. Provide a means of evaluating IEP effectiveness, thereby enabling a better use of          special education funds and a reduction of litigation over IEP plan appropriateness and          utility.        3. Provide substantial support for our theoretical rationale for curriculum building in          Special Education - a rationale that can guide the formulation of IEPs.        4. Provide a theoretical rationale, an intervention framework, and intervention support          technology that can be extended to cognitive behavioral treatment of other          neuropsychiatric disorders and can be adapted for other forms of healthcare guidance.        5. Provide an investigative system, as well as an intervention system, for tracking          behavioral change in studies of frontal lobe and limbic neuroplasticity in          neuropsychiatric disorders.   "
229392|NCT00848887|"     This study will evaluate the safety and immunogenicity of different combinations of influenza     vaccine in healthy young children.   "
229393|NCT00848900|"     The purpose of this study is to assess whether outdoor activities are effective in preventing     the development and progression of juvenile-onset myopia in Chinese children.   "
229394|NCT00848913|"     The purpose of this study is to examine the effect of progressive strength training of the     fractured limb in patients with hip fracture, during admittance in an acute orthopedic ward.     The primary study hypothesis is that the training will reduce the strength deficit in the     fractured limb in comparison with the non-fractured limb. Secondary, that patients following     the intervention will present larger improvements in physical function compared to controls.   "
229395|NCT00848926|"     This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the     efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with     relapsed or refractory Hodgkin lymphoma.   "
249579|NCT01122966|"     The investigators plan to evaluate the additive effect of intracameral and subconjunctival     injections of bevacizumab in trabeculectomies with other antimetabolites.   "
229396|NCT00848939|"     This study will assess the pharmacokinetic and safety profile of treprostinil following fixed     and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study     assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine     SR. Cohort 1: single 1 mg treprostinil diethanolamine SR dose. Cohort 2: escalating doses of     treprostinil diethanolamine SR up to a target dose of 4 mg BID.   "
229397|NCT00848952|"     The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI,     CTscanner and enhanced contrast ultrasound for the diagnosis of small (< 3 cm) hepatocellular     carcinoma for patients with cirrhosis.   "
229398|NCT00848965|"     This is a single-centre, randomised, double-blind, four-period, incomplete block, crossover     study, with 8 days repeat dosing of intranasal Fluticasone Propionate (25, 50, 100, 200ug)     and/or placebo in the Vienna Challenge Chamber in subjects with allergic rhinitis.   "
229399|NCT00848978|"     The Health Enhancing Strength Training in Nonagenarians (STRONG) is a randomised control     trial to assess the effectiveness of an aerobic and strength training program for improving     functional capacity and quality of life in nonagenarians. Sixty (51 women) nonagenarians (age     range: 90-102 years) who live in a geriatric nursing home will be randomly assigned to either     a usual care (control) group (n=30) or an intervention (training) group (n=30). Participants     allocated in the usual care group will receive general physical activity guidelines and     participants allocated in the intervention group will also enroll in three weekly     non-consecutive individualized training sessions (~45-50 min each) during 8 weeks. The     exercise program will consist of muscular strength [with a special focus on leg press at 30%     (start of the program) to 70% 1 repetition maximum (end)] and aerobic exercises     (cycle-ergometry during 3-5 to 15 minutes at 12-14 points in the rate of perceived exertion     scale). Results from STRONG will help to better understand the potential of regular physical     activity for improving the well-being of the oldest population groups.   "
229400|NCT00848991|"     Primary Hypothesis: The use of a Precedex infusion, in addition to propofol during surgery,     will improve patient management through the anesthesia postoperative recovery period     determined by improvement in patients? tolerance of the endotracheal tube.      Secondary hypothesis: The use of a Precedex infusion, in addition to propofol during surgery     will provide improved hemodynamic stability.   "
229401|NCT00849004|"     Keloids and hypertrophic scars are not major illness. However, their effects can be from     causing pain and itch which substantially interfere daily activity to as severe as causing     deformity and other functional impairment. For standard surgical wounds, taking median     sternotomy wounds from open heart surgery and lower abdominal wounds from gynecological     wounds for example, the incidence of these problems can be from 10% to 60%. To prevent or     treat these problems, physicians have used many modalities. One of the most convenient, most     cost-effective and most non-invasive methods for patients is using dressings like silicone     sheets, silicone gels or paper tapes, which is on the list of 1st line choices of an     international recommendation. According to a literature review, most of the previous studies     on similar topics are either of small sample size, on non-standard wounds or comparisons     between wounds on different patient groups. The methodologies of previous studies are thus     not vigorous enough. To get the highest level of evidence on selecting the best dressings for     preventing and treating keloids and hypertrophic scars, we will recruit about 75 patients and     apply two selected dressings on each halves of their standard surgical wounds to compare     their differences. The investigators hope the result of this study can help us find the best     modality to use and can contribute to the welfare of our future patients.   "
229402|NCT00849017|"     The purpose of this study is to determine whether albiglutide is effective in the treament of     patients with type 2 diabetes.   "
229403|NCT00849030|"     The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is     beneficial in the treatment of breast cancer.   "
229404|NCT00849043|"     The purpose of this study is to evaluate the long-term durability of the treatment and safety     of the Provent device for those individuals who were enrolled in the C009 study, were     diagnosed with obstructive sleep apnea-hypopnea (OSAH), and were actively using the Provent     device.   "
229405|NCT00849056|"     The purpose of this study is to determine the safety, tolerability and efficacy of     albiglutide in the treatment of type 2 diabetes.   "
229406|NCT00849069|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of     GSK2231395A candidate vaccine in adults and elderly adults with chronic obstructive pulmonary     disease. Subjects will be vaccinated 3 times with an interval of respectively 2 and 10     months.   "
229407|NCT00849082|"     RATIONALE: Radiation therapy uses high energy x rays to kill tumor cells. This may be an     effective treatment for prostate cancer. Androgens can cause the growth of prostate cancer     cells. Antihormone therapy, such as goserelin and cyproterone, may lessen the amount of     androgens made by the body and reduces the amount of androgens available to the body. It is     not yet know whether radiation therapy alone is more effective than radiation therapy given     together with goserelin and cyproterone in treating patients with prostate cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works compared to giving radiation therapy together with goserelin and cyproterone in     treating patients with prostate cancer that is at high risk for metastasis.   "
229408|NCT00849095|"     Study No.001 about Budesonide/Formoterol use in ASthMA sponsored by Agenzia Italiana del     FArmaco (Italian Drug Agency) (AIFA-ASMA-BF-001) The aim of the study is to verify whether     asthma not controlled by low doses inhaled corticosteroids, thus in need for step up therapy,     can be equally controlled by guidelines recommended regular bid treatment with long acting     beta agonist/inhaled corticosteroid (ICS/LABA) combination or the symptom driven use of an     ICS/LABA combination in the absence of maintenance therapy. The study is designed to be able     to evaluate the non inferiority of regular placebo plus prn inhaled budesonide/formoterol     (experimental treatment) versus regular, twice daily 160/4.5 mcg inhaled     budesonide/formoterol combination plus prn inhaled terbutaline (guidelines recommended     treatment).   "
229409|NCT00849108|"     The main purpose of this study is to get more information on using BMS747158 (the study     drug),a drug with small amounts of radioactivity to allow for heart imaging, during a PET     scan which can then be compared to other images such as SPECT. The safety and quality of     images will be studied.   "
229410|NCT00849121|"     The investigators are trying to find new methods to treat prostate cancer. The approach is to     try to enhance patients' own immune response against the cancer. In this study, the     investigators will be testing the safety of a vaccine that may be able to help the body fight     prostate cancer.      The vaccine, called pTVG-HP, is a piece of DNA genetic material that contains genetic code     for a protein that is made by the prostate gland, called prostatic acid phosphatase (PAP).     The vaccine will be given together with a substance called an adjuvant. Adjuvants are     typically given with vaccines and can improve the effect of the vaccine. The adjuvant that     will be used in this study is called granulocyte-macrophage colony-stimulating factor     (GM-CSF).      The main purpose of this study is to find out whether the vaccine generates long-lived immune     responses, and whether a better schedule of vaccination can be found by doing frequent     laboratory testing for immune responses. The investigators also want to see if the vaccine     stimulates any immune reaction against cancer cells.   "
229411|NCT00849134|"     This is a first-time-in-human study. The overall purpose of the study is to assess whether     the drug is safe and well tolerated after single, increasing doses. At different doses, we     will look to see how much of the drug gets into the bloodstream, how the drug is broken down     and excreted and whether this is affected by the presence of food.   "
229412|NCT00849147|"     Bone marrow transplants are one treatment option for people with leukemia or lymphoma. Family     members or unrelated donors with a similar type of bone marrow usually donate their bone     marrow to the transplant patients. This study will evaluate the effectiveness of a new type     of bone marrow transplant—one that uses lower doses of chemotherapy and bone marrow donated     from family members with only partially matched bone marrow—in people with leukemia or     lymphoma.   "
229460|NCT00856193|"     This study was intended to assess how well inhaled NVA237 opens up the airways of patients     with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.   "
229413|NCT00849160|"     Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to     reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in     vivo studies have shown that the induction of resistance mutations in the protease gene is     much more difficult with the association darunavir/r compared to the other ritonavir-boosted     protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to     resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of     this molecule allows a once daily administration with a 800/100 mg dose in patients infected     with a wild HIV strain or with a slightly resistant to darunavir/r strain.      Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a     substitute to a protease inhibitor regimen administered twice daily in patients with     undetectable viral load receiving a tritherapy including a protease inhibitor administered     twice daily.   "
229414|NCT00849173|"     Endometriosis, a condition in which the lining of the uterus grows on nearby tissues, is a     common condition that affects women of reproductive age worldwide. The diagnosis of     endometriosis is usually made at surgery. The most common symptom is pelvic pain. This pain     may occur at the same time as menstrual bleeding, at other times of the cycle, or during or     after sexual intercourse. Previous studies reveal the diagnosis of endometriosis is often     delayed between 8 and 12 years after the first symptoms. Women with chronic pelvic pain     report a lower quality of life. No studies, however, have been conducted to assess whether     women with endometriosis-related pelvic pain are affected differently than those with pelvic     pain from other or no identifiable causes.      This large-scale study is designed to gather prospective epidemiological data on the impact     of and risk factors for endometriosis across countries worldwide. A study of this scale and     scope has never been performed; it is anticipated that the study will provide novel insights     into the effects of the condition and associated symptoms on women s lives across different     countries, as well as explore differences in the effects of various potential risk factors.      This is an international study conducted at more than 20 sites worldwide and coordinated by     Oxford University in the United Kingdom. At the National Institutes of Health, 250     premenopausal women between 18 and 45 years of age who are having their first diagnostic     laparoscopy or laparoscopy for tubal sterilization will participate. None will have had a     prior diagnosis of endometriosis through surgery. Women will be informed about the study when     their laparoscopy is scheduled.      Procedures        -  Patient completion of an online questionnaire before scheduled surgery. The following          will be assessed by the questionnaire:        -  Quality of life        -  General gynecologic and medical history        -  Family history        -  General information        -  Use of health care services        -  Risk factors        -  Surgeon completion of questionnaire about surgical findings.        -  Follow-up: Women who consent will be contacted every 1 2 years.   "
229415|NCT00849186|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed.      PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery     and to see how well it works in treating patients with localized or metastatic kidney cancer.   "
229416|NCT00849199|"     The purpose of this study is to collect information from a large group of women who may have     a greater chance to develop cancer because of their own personal history of cancer or because     of their family history of cancer.   "
229417|NCT00849212|"     The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese     patients with refractory partial seizures which are uncontrolled with other anti-epileptic     drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per     day). The dose of E2007 will be adjusted during 6 weeks. Subsequently, the dose will be fixed     and maintained during 4 weeks.   "
229418|NCT00849238|"     The rationale for this study is to determine if Campath-1H can be used in liver transplant     recipients to induce a state of immunological unresponsiveness that would not only eliminate     the need for calcineurin inhibitors maintenance therapy, but also reduce corticosteroids     utilization, decreasing the incidence of acute cellular rejection and perhaps reduce the     severity of histologic recurrence of certain autoimmune diseases responsible for causing     liver failure. The investigator propose a randomized prospective open label trial in 50 liver     transplant recipients who will received a calcineurin inhibitors free immunosuppressive     protocol that consist of a single dose of Campath-1H as an induction therapy in association     with maintenance mycophenolate mofetil (CellCept®) and low dose steroids. The second group     will receive a standard immunosuppressive regimen, which consists of IV steroid induction     therapy and maintenance steroids, together with tacrolimus at a full therapeutic dose with no     induction antibody therapy.   "
229488|NCT00856570|"     This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to     exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and     tolerability of warfarin alone and combined with YM178.   "
229489|NCT00856583|"     The purpose of the study is to determine whether there is an increased all-cause mortality in     sertindole-treated patients in comparison to patients treated with a well-known antipsychotic     (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.   "
229419|NCT00849251|"     RATIONALE: Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride     and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to     the cancer. Giving pegylated liposomal doxorubicin hydrochloride together with bortezomib,     cyclophosphamide, and dexamethasone may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects of giving pegylated liposomal     doxorubicin hydrochloride together with bortezomib, cyclophosphamide, and dexamethasone and     to see how well it works in treating patients with multiple myeloma   "
229420|NCT00849264|"     This study is working to evaluate the surgical comprehensive treatment for different types of     tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a     standardized, unified, effective therapeutic program.   "
229421|NCT00849277|"     The purpose of this study is to determine whether probiotic treatment improves the protection     against respiratory infections after influenza vaccination in elderly living in nursing     homes.   "
229422|NCT00849290|"     This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease     progression on protocol D9902 part B (NCT00065442)   "
229461|NCT00856206|"     The purpose of this clinical research study is to determine the safety and effectiveness of     an experimental drug called rilonacept in subjects with gout who are on urate-lowering     therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is     being studied for use in preventing gout flares in subjects on urate-lowering therapy.   "
229423|NCT00849303|"     The purpose of the first part of this study is to understand plastic brain mechanisms     associated with successful gait-oriented stroke rehabilitation. Patients are randomized to     receive intensive in-patient multiprofessional rehabilitation at different time points. One     group will receive rehabilitation immediately after an acute care at the neurological clinic     (8 days) and one group 5 weeks after the insult. Patients practise walking every workday for     60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive     also other physiotherapy. In addition to selected parameters measuring brain plasticity,     detailed assessments of functional abilities including motor ability and quality of life will     be performed. A novel tool, MR-image navigated transcranial magnetic stimulation (TMS) is     utilized in assessing cortical excitability in relation to stroke, time, rehabilitation, and     recovery.   "
229424|NCT00849316|"     This study is conducted in Asia. The aim of this observational study is to investigate the     clinical safety profile and effectiveness while using SC NovoRapid™ (insulin aspart) in     patients with coexisting diabetes and kidney disease under normal clinical practice     conditions in India.   "
229425|NCT00849329|"     This study will characterize the effect of elevated gastric pH mediated by the proton-pump     inhibitor, esomeprazole, on the relative bioavailability of lapatinib in subjects with     metastatic ErbB2 positive breast cancer.   "
229426|NCT00849342|"     This study is conducted in Europe. The aim of this observational study is to investigate the     effect of switch from other basal insulin treatments to Levemir® on body weight in obese     diabetic patients. A local extension will be conducted in Slovenia in order to reach the     planned 400 patients for the sub-analysis of Slovenian patients.      Included in the study is a retrospective part to evaluate the weight progress since     initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD)     and/or bolus insulin therapy. Retrospective data will be collected at baseline and at     approximately 6 and 12 months before starting insulin detemir therapy.   "
229427|NCT00849355|"     The purpose of this study is to evaluate the efficacy (and safety) of the following treatment     squeme:Ciclophosphamide, Vincristine, lyposomal Doxorrubicine (Myocet) and     Prednisone,combined with Rituximab in first line treatment for patients with aggresive No     Hodgkin B lymphoma and cardiovascular risk   "
229428|NCT00849368|"     Main Study Objectives:      The study is conducted to        -  evaluate the minimal allopurinol and azathioprine doses that, in combination, produce          therapeutic 6-TGN levels        -  evaluate the safety and tolerability of the different allopurinol/azathioprine dose          levels        -  assess if concomitant allopurinol affects TPMT activity        -  assess the clinical efficacy of concomitant allopurinol-azathioprine therapy in the          included patients   "
229429|NCT00849381|"     This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV     vaccine GSK580299 in female subjects who took part in study 008/580299 and received the     control vaccine (Hepatitis A vaccine).   "
229430|NCT00849394|"     This is a clinical research study to look at the incidence of proteinuria (a condition in     which urine contains an abnormal amount of protein) caused by shortened infusions (given into     the vein over 10 or 15 minutes) of bevacizumab (a medication prescribed for colon, lung, or     breast cancer). There are currently no published studies or clinical data looking at how safe     shortened infusions of bevacizumab are in relationship to the side effect of proteinuria. We     hypothesis that shortened infusions of bevacizumab will result in an increased risk for     proteinuria compared to the standard infusions of this agent.   "
229432|NCT00849433|"     Asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory airway     diseases affecting millions of people worldwide. Inhaled corticosteroids (ICS) are by far the     most effective treatment with a broad anti-inflammatory spectrum. Nevertheless, most COPD     patients and a proportion of severe asthma patients are corticosteroid-resistant (CR) and to     fail to respond to ICS even when higher doses are given. These corticosteroid-resistant     patients suffer from persistent symptoms and repeated asthma exacerbations. It has been     suggested that smoking and oxidative stress may induce corticosteroid-resistance. The     reactive oxygen species (ROS) responsible for oxidative stress can be generated exogenously     (air pollutants, cigarette smoke) and endogenously by metabolic reactions. After inhaling air     pollutants or cigarette smoke, the bronchial epithelium is exposed. Preliminary data from our     own lab suggest that smoking and oxidative stress may decrease epithelial cell-cell contact     formation. This results not only in a decreased barrier function, but also in an increased     production of pro-inflammatory mediators.   "
229433|NCT00849446|"     Background:Accelerometry has only recently been introduced in clinical stroke research.     However, whether accelerometry is a valid and reliable tool in stroke needs to be     established. From literature becomes clear that existing accelerometers show shortages at     patients with stroke because of the specific deficits that these patients have.      Purpose: The aim of this study is to investigate the validity and test-retest reliability of     the SenseWear Pro armband as an objective measurement of physical activity in chronic stroke     patients.      Patients and Methods Subjects: Fifteen patients and fifteen healthy subjects will be included     in the study following written informed consent. The following demographic and clinical data     were recorded: age, gender, height, length, medication use, self-reported handedness,     Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories,     medical and surgical history.      Methods: During one test session the subjects had to carry out an amount of activities     according to a standardised protocol existing of lying down, sitting, standing, walking, step     exercise and cycling. These activities are presenting activities of daily living.      Measures:Subjects wear on both arms a SenseWear Pro Armband. De data from these measuring     devices will be compared with the data retrieved from 2 Yamax pedometers and the     ergospirometry device. The outcome measures are: counts, heartbeat, oxygen used, energy     expenditure, METabolic equivalent, time lying down.   "
229434|NCT00855764|"     The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given     weekly in patients with advanced or recurrent head and neck cancer   "
229477|NCT00856414|"     This study evaluates the patient satisfaction and onset of effect following treatment with     botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)   "
230348|NCT00871247|"     The purpose of this study is to compare the rate and extent of absorption of Actavis Group     hf, Iceland, finasteride and Merck & Co. Inc., U.S.A. (Proscar), finasteride, administered as     a 1 x 5 mg tablet, under fed conditions.   "
229435|NCT00855777|"     The aim of this study is to evaluate the analgesic efficacy of etoricoxib compared with a     well known and widely used non-steroid antinflammatory drug, ibuprofen, in third molar     extraction pain. At this time, there are no data about the efficacy of etoricoxib for     reducing pain following dental extraction.      This will be a single center, randomized, double-blind study, in which patients with moderate     to severe pain following third molar extraction will be randomized to receive etoricoxib (120     mg in a single dose + 2 dose of placebo pro day for 3 days) or ibuprofen (1800 mg in 3 doses     pro day for 3 days). Paracetamol plus codeine will be used as rescue medication. Pain     assessment will be performed using a 11-point pain intensity scale (0 = no pain and 10 =     worster pain) during the first 3 days after dental extraction. Patients will be enrolled 15     days before the dental extraction. During enrollment visit a complete clinical evaluation     with particular attention for potential exclusion criteria (e.g. hypertension and     cardiovascular risk factors) as well as blood analyses will be performed. A follow-up visit     will be performed 15 days after the dental extraction. Tolerability will be assessed through     recording of adverse events.   "
229436|NCT00855790|"     The purpose of this study is to evaluate the efficacy of the new RJ4 compare with the     standard RJ3 biopsy forceps for performing polypectomy for small colorectal polyps.   "
229437|NCT00855803|"     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the     tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and     spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation     therapy together with vertebroplasty may help lessen pain and improve quality of life of     patients with spinal metastasis.      PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy     together with vertebroplasty works in treating patients with localized spinal metastasis.   "
229438|NCT00855816|"     Hyperarousal is a key symptom of PTSD. Even after receiving trauma-focused therapy, PTSD     patients may continue to suffer from hyperarousal. Our main objectives are to measure     hyperarousal in VA outpatients with PTSD related to combat experience in the last 10 years     and to test the efficacy of physiological relaxation training in reducing this hyperarousal.     Measurements will be both physiological, using 24 hour ambulatory monitoring of skin     conductance, heart rate, and physical activity during waking and sleeping, and psychological,     using self-reports and clinician interviews. Specific aims include initially evaluating 100     or more PTSD patients for the severity of their hyperarousal symptoms. Of these, 50 with at     least moderate hyperarousal who either have participated in a trauma-focused therapy or have     declined to participate in such a therapy will be recruited for a therapy trial. Volunteers     will be randomized to treatment consisting of 5 sessions of individual physiological     relaxation training with biofeedback over a 4-week period or to a 2-month waiting period     after which they also may receive this therapy. Physiological evaluations of the patients'     ability to relax will be measured at three times -before treatment, immediately after     treatment, and 6 months after treatment. Clinical evaluations by interviews and     questionnaires on measures of symptoms and disability will be measured at four times - before     treatment, immediately after treatment, 1 month after treatment, and 6 months after     treatment. The waiting-list group and a nonanxious control group will be tested     psychophysiologically twice at the same interval as the patients before and immediately after     treatment. A control group will allow us to calibrate our measures in the setting in which     they are being applied. We hypothesize that this therapy will relieve both self-reported and     objective, physiological symptoms of hyperarousal.      Relevance to health and the VA mission: Many of our clients at the VA Palo Alto Mental Health     Outpatient Services for PTSD are veterans of Iraq, who need help with hyperarousal symptoms.     This study will fill in gaps in our knowledge about the physiology of these symptoms and     about the efficacy of relaxation therapies. Non-pharmacological treatments like the ones that     we propose may relieve patients' hyperarousal to an extent that they are less tempted to turn     to alcohol or sedative drugs.   "
229439|NCT00855829|"     ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain     associated with menstruation (clinically known as dysmenorrhea).   "
229440|NCT00855842|"     One the day prior to medical abortion (labor induction) in the second trimester, insertion of     osmotic dilators is added to the routine procedures. The study is to see whether the addition     of dilators decreases the abortion time (time for the pregnancy to be expelled)   "
229441|NCT00855855|"     To monitor the occurrence of invasive Hib disease over time and to determine product-specific     rates of invasive Hib disease within the monitored population.   "
231497|NCT00883675|"     The purpose of this study is to determine whether it is safe to treat lung cancer patients     who have undergone an attempt at curative resection with the combination of docetaxel and     carboplatin.   "
229442|NCT00855868|"     This study will evaluate the performance characteristics of a novel [18F] amyloid detection     ligand (18F]-AV-45) with respect to its ability to distinguish patients with     clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects     and to independently compare its diagnostic performance characteristics with the ability of     [11C]PIB to correctly categorize the same subjects.      SPECIFIC HYPOTHESES        1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have          increased brain retention of [18F]-AV-45 compared to cognitively normal elderly          individuals.        2. There will be no clinically meaningful difference in the amyloid retention performance          characteristics of [18F]-AV-45 and [l1C]PIB.   "
229443|NCT00855881|"     It is the investigators understanding that the combination of clinical trial with laboratory     cellular/molecular assay is relevant to the current promising mainstream, the translational     research. The design of this trial fulfills this concept and would be a good example     conducting in Mackay Memorial hospital.   "
229444|NCT00855894|"     This was a Phase II, open-label, single-arm, single-stage, multicenter trial in patients with     relapsed non-small cell lung cancer (NSCLC), with the objective of assessing the activity of     the combination of erlotinib and pertuzumab on the basis of the endpoint of FDG-PET response     rate.   "
229445|NCT00855907|"     Fatty liver is known to be one of the most frequent liver pathologies in IBD patients     (35-40%). Despite this fact, there are only few publications that evaluated the prevalence of     fatty liver in IBD patients. Moreover, the pathogenesis of this phenomenon in IBD has not     been widely investigated.      The paradox of lean patients and fatty liver can be explained by high use of steroids, by     rapid weight loss, and by the abundance of TNFα cytokine in IBD patients that causes insulin     resistance.      The aim of the study:      To evaluate the frequency of fatty liver in a cohort of IBD patients and to learn its risk     factors.      Methods:      One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be     recruited.      Patients will fill up a questionnaire regarding their disease, demographic data, other     co-morbidities and medications and risk factors for metabolic syndrome.      Each patient will undergo blood examinations in order to assess inflammation, and metabolic     status. Fatty liver will be assessed by liver ultra-sonography.   "
230004|NCT00865189|"     This study will assess the efficacy and safety of two different neoadjuvant treatment     approaches including bevacizumab in newly diagnosed participants with high risk locally     advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A     or Arm B).   "
229448|NCT00855946|"     Treatment for locally-advanced rectal adenocarcinoma includes preoperative radiochemotherapy     before surgery with total mesorectal excision in order to reduce tumor infiltration,     facilitate oncologic surgery and improve survival. About fifty percent of these patients are     good responders i.e. their tumor infiltration reduces in the rectal wall and regional lymph     nodes in order to be graded ypT0 to T2 N0 after pathologic assessment (so called     downstaging). At the opposite, bad responders (ypT3-4 and/or N+) are not sensitive to     standard preoperative radiochemotherapy, and their survival is poor than good responders.     Until now, response to preoperative radiochemotherapy cannot be anticipated before     pathological assessment of surgical specimen. Proteomic analysis of sera from good and bad     responders to preoperative radiochemotherapy could allow identification of early biomarkers     of tumor response, and subsequently adaptation of treatment to increase preoperative     treatment efficiency and survival in most patients.   "
229449|NCT00855959|"     The primary objective of the study is to show similarity of efficacy on Pulmicort Respules     1.0 mg/day or 2.0 mg/day for 6 weeks in the treatment period and the corresponding doses of     Pulmicort Turbuhaler 400 μg/day or 800 μg/day for 4 weeks in the observation period in     Japanese adult asthmatic patients with age of 16 years or older.   "
229450|NCT00855972|"     The purpose of this research is to obtain data or information on the safety and effectiveness     of low dose naltrexone (LDN) for treating the symptoms of juvenile primary fibromyalgia     syndrome. This is a dose finding study to find whether LDN helps the symptoms of juvenile     fibromyalgia, and at what dose it does so.   "
229451|NCT00855985|"     There are two principal ways of draining the remnant of the pancreas back into the intestine     after removal of the head of the pancreas for cancer. This can be performed either to the     jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients     to one of the two arms to study whether the leak rates from the anastomosis and the outcomes     after the surgery are affected.      Previous papers have shown similar results in both groups although non randomized data     suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior   "
229452|NCT00855998|"     This study aimed to compare the activity of Thymidine Kinase 1 in serum of two groups of     woman at high and normal risk for breast/ovary cancer.   "
229453|NCT00856011|"     The underlying basis of carpal tunnel syndrome and the basis of its increased incidence in     diabetes are unknown. The aim of this study was to quantified pathology in an uncompressed     nerve (posterior interosseous nerve in the forearm between diabetic and non-diabetic patients     with CTS.   "
229454|NCT00856024|"     This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open,     noncomparative, and nonrandomized study, which does not have visits. This study will be     conducted in accordance to Good Clinical Practices. The procedure will be the review of     medical records of patients who have already completed 12 weeks of treatment of chronic     hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the     subjects have signed the informed consent form authorizing collection of these data. The     collection of data for virological response after Week 12 will be collected prospectively     through the review of medical records after the subjects have completed their entire     treatment and follow-up period.   "
229490|NCT00856596|"     The topical cream, Sertaconazole (Ertaczo), has been FDA approved for the treatment of     athlete's foot using twice a day dosing for 4 weeks. This study wants to see if sertaconazole     will work equally as well with once a day dosing for 4 weeks for athlete's foot.   "
229455|NCT00856037|"     This phase I trial studies the side effects and best dose of topotecan hydrochloride when     given together with doxorubicin hydrochloride in treating patients with small cell lung     cancer (SCLC) that has come back after a period of improvement (relapsed) or has not     responded to treatment (refractory). Drugs used in chemotherapy, such as topotecan     hydrochloride and doxorubicin hydrochloride, work in different ways to stop the growth of     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. Doxorubicin hydrochloride may also stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Giving topotecan hydrochloride and doxorubicin     hydrochloride may be a better treatment for small cell lung cancer.   "
229456|NCT00856050|"     The purpose of this research study is to determine if letrozole is effective at controlling     the growth or spread of estrogen and/or progesterone receptor positive uterine     leiomyosarcoma. This drug has been used in research studies for other cancers and is     currently approved by the FDA for use in breast cancer. Because letrozole lowers hormone     levels in the body, it may be helpful to control tumors that express hormone receptors (     ER/PR).   "
229457|NCT00856063|"     The goal of this pilot feasibility and utility study is to develop and validate a method that     is reproducible over time for assessing biobehavioral and autonomic markers of impulsivity     and their utility in assessing treatment outcome in preschool children with ADHD.   "
229458|NCT00856076|"     The purpose of this study is to investigate clinical, biochemical and genetic risk factors     for venous thromboembolism in pregnancy and pregnancy related vascular complications, and the     long-term outcome of such complications including implications for quality of life.   "
229459|NCT00856089|"     The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is     effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal     colonization. The hypothesis is that the prevalence of MRSA increases as a function of     increasing clinical exposure and that the topical antibiotic Altabax is efficacious in     clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane     University medical students and residents and physicians of Tulane Medical Center and Ochsner     Medical Center will be investigated. A total of 300 subjects will be recruited for the study.     After giving informed consent, subjects will be swabbed to obtain specimens for culture and     asked to complete a short survey to assess risk factors. Swabs will be used to directly     inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with     sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and     then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects     will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin     ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days.     After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at     day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will     additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin     (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition,     Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by     rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk     factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data     from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA     nasal colonization.   "
229462|NCT00856219|"     Literature suggests that route of feeding and/or certain nutrients may cause alterations in     the body's immune cells. Immune cells help protect the body and fight infection/disease. Tube     feeding (TF) is a method of delivering nutrition directly to the stomach/intestines via a     small tube. The immune system may respond differently when receiving continuous TF as     compared to receiving intermittent TF. Heart rate variability (HRV, the intervals between     heartbeats) is a measurement of the nervous system's response to a stress/illness. The     differences in immune cells and/or HRV may influence how the body reacts to complications     such as infection.   "
229463|NCT00856232|"     This study will randomly assign emergency department patients seeking treatment for a     headache to one of three groups. The first group will receive standard emergency care as     determined by the treating physician, the second group will breathe high flow air by facemask     for 15 minutes, and the third group will breathe high flow oxygen by face mask for 15     minutes. The patients will be questioned in the beginning of their treatment and at 2, 5, 10,     15 and 30 minutes after it's begun about the intensity of their headache and how much relief     they are experiencing from their treatment. Concentration of carbon dioxide exhaled by     patients will also be recorded at 0, 2, 5, 10, 15 and 30 minutes. After fifteen minutes, the     patients in groups 2 and 3 will continue with standard emergency care, which can include any     treatment their physician sees fit. Patients in all three groups will receive a stopwatch in     the beginning of their emergency department visit and record the total extent of time their     headache will take to resolve.   "
229464|NCT00856245|"     Researchers hope to learn if adding rituximab with high doses of chemotherapy and stem cell     transplantation will help patients get rid of their lymphoma cells from the bone marrow and     stem cell collections.   "
229465|NCT00856258|"     To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.   "
229466|NCT00856271|"     The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil     compared with losartan potassium in patients with mild to moderate essential hypertension.   "
229467|NCT00856284|"     The purpose of this study is to determine the safety and effectiveness of adding alogliptin,     once daily (QD), compared to glipizide with metformin in diabetic patients.   "
229468|NCT00856297|"     The primary objective is to evaluate the persistence of bactericidal antibodies in     adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY     Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also     enroll age-matched subjects who have never received any other meningococcal vaccine (naïve     subjects) to serve as an additional control group.   "
229469|NCT00856310|"     This is a randomized, double-blind, placebo-controlled single-dose study of the safety and     tolerability of intravenously administered REGN475 in healthy volunteers. The primary     objective of the study is to assess the safety and tolerability of REGN475. The secondary     objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.   "
229470|NCT00856323|"     This study seeks to decrease methamphetamine use and concomitant high-risk sexual behaviors     among methamphetamine-using men who have sex with men (MSM) by combining a biomedical     intervention with a behavioral intervention. The behavioral intervention will consist of an     8-week course of contingency management (CM) through which participants will be reinforced     for testing negative for methamphetamine metabolites during periodic urine analyses. The     biomedical intervention involves a 28-day course of an antiretroviral drug (Truvada) to be     administered after an unanticipated HIV risk exposure (i.e., engaging in either receptive or     insertive anal sex without a condom with someone who is HIV-positive or of unknown status).     In combining these two interventions, this study seeks to evaluate the combined     intervention's effects on sexual risk behaviors and methamphetamine use.   "
229471|NCT00856336|"     This was a phase I study aimed at identifying safe doses of DMXAA (now known as ASA404) to be     used in future combination studies with chemotherapy.   "
229472|NCT00856349|"     The purpose of this clinical trial is to determine whether periodic therapy programming     reports illustrating physician usage of shock reduction programming can increase utilization     of recommended programming guidelines for defibrillators.   "
229473|NCT00856362|"     The purpose of this study is to evaluate the effect of single doses of midazolam on the     plasma concentration of a single dose of moxidectin in healthy young adult subjects, and to     assess the safety of co-administration of moxidectin and midazolam.   "
229474|NCT00856375|"     This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect     in patients with colorectal cancer. This study will also evaluate how the safety and     anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for     use in the US for treatment of patients with certain types of colorectal cancer.   "
229475|NCT00856388|"     This clinical trial is studying how well giving fludarabine phosphate and melphalan together     with total-body irradiation followed by donor stem cell transplant works in treating patients     with hematologic cancer or bone marrow failure disorders. Giving low doses of chemotherapy     and total-body irradiation before a donor peripheral blood stem cell transplant helps stop     the growth of cancer cells or abnormal cells. It may also stop the patient's immune system     from rejecting the donor's stem cells. The donated stem cells may replace the patient's     immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor     effect)   "
229476|NCT00856401|"     The purpose of this protocol is to add on additional exploratory studies to investigate     changes in bone quality parameters with PTH(1-84) treatment of hypoparathyroidism. In     addition to the biochemical hallmarks of hypoPT, it has been found that the microscopic     structure of the bone, as well as the bone remodeling system, are markedly abnormal in this     disease. How these abnormalities may be corrected with PTH(1-84) administration are not fully     understood. The studies outlined in this add-on protocol are designed to shed light on the     mechanistic ways that PTH(1-84) replacement may restore normal bone metabolism. These     mechanistic studies are beyond the scope of the parent NPS study, which was designed to     assess the safety and efficacy of PTH(1-84) in hypoPT treatment. Subjects who are     participating in the NPS' REPLACE, RELAY, and RACE Studies and the HEXT Study at Columbia     University will be invited to participate in this add-on protocol, which will involve a     separate IRB-approved informed consent.      Study procedures:        1. High Resolution Peripheral Quantitative Computed Tomography (HRpQCT; XtremeCT, Scanco):          Done at the same visit as DXA. In the REPLACE study twice, in RELAY once (or not at all          if done within the last 6 months), in RACE twice, and in HEXT three times.        2. Osteolineage: At Baseline/Randomization/Visit One and at 4, 8, 12, 24, and 52 weeks of          treatment in the REPLACE, RELAY, or RACE Study, if applicable, or at baseline and each          6-months visit in the HEXT Study, blood test for circulating osteogenic cells (10 cc)          will be performed        3. Sclerostin: At Baseline/Randomization/Visit One and at 4, 8, 12, 24, and 52 weeks of          treatment in the REPLACE, RELAY, or RACE Study, if applicable, or at baseline and each          6-months visit in the HEXT Study, blood test for sclerostin (5cc) will be performed      Funding Source - FDA OOPD   "
229478|NCT00856427|"     This clinical trial studies imaging markers in planning radiation therapy in patients with     lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during     radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to     normal tissue.   "
229479|NCT00856440|"     Periodic screening for colon cancer has become the standard of care in individuals over the     age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive     modality for the detection of colon cancer and/or pre malignant colon pathology. As currently     performed, however, colonoscopy requires that stool be eliminated from the colon before the     examination. If stool remains in the colon, visualization of the bowel will be partially or     completely impaired and limits the effectiveness of the screening. A number of methods are     employed for purging the bowel of waste material but they generally involve either     administration of a lavage (like a flush) solution (such as Colyte or Golytely) or of an     osmotic laxative (such as sodium phosphate or magnesium citrate). Neither of these approaches     is uniformly effective in all individuals and neither is without potential complications,     especially on the kidneys. It is the intent of the proposed research to study the relative     efficacy and safety of these preparations in both able-bodied individuals as well as people     with spinal cord injury. To this end, we will randomize these groups to a lavage solution, a     laxative or a combination of the two prior to a routine, clinically indicated colonoscopy.     The quality of the preparation will be directly assessed during the colonoscopy and the     effect of these preparations on kidney function will be determined. We suspect that when it     comes to preparation for colonoscopy, one shoe does not fit all sizes. The proposed research     should allow us to determine which form of preparation is least harmful while achieving     optimal effectiveness.   "
229480|NCT00856453|"     RATIONALE: Yoga may decrease fatigue, distress, and depression, and improve sleep quality in     patients undergoing chemotherapy for ovarian cancer. It is not yet known whether practicing     yoga in group classes is more effective than practicing yoga at home.      PURPOSE: This randomized clinical trial is studying how well yoga works in relieving fatigue     in patients undergoing chemotherapy for ovarian cancer.   "
229505|NCT00856791|"     ON 01910.Na has undergone preclinical and clinical phase I studies showing activity in     patients with progressing ovarian cancer resistant to platinum-based chemotherapies. This     study will look at a larger population of patients to determine whether treatment with ON     01910.Na has an effect on progression free survival rates in patients with platinum-resistant     ovarian cancer. ON 01910.Na will be given as an intravenous infusion over 2 hours on days 1,     4, 8, 11, 15, and 18 of a 28-day cycle. Patients will be treated for 6 or more cycles.   "
229481|NCT00856479|"     We are inviting individuals such as yourself, who have diaphyseal fracture (broken bone) with     a non union to participate in this research study. A non-union is a lack of bone healing     (bone growth where the break in the bone occurred) after 3 months after the operation. The     diaphyseal is an area of a specific bone (usually near the middle) where the fracture     occurred. The bones we are interested in are the clavicle (collar bone), tibia (lower leg),     femur (upper leg), humerus (upper arm) and forearm (lower arm). Treatment goals for these     types of fractures are to minimize later surgeries, to assist the healing process, and to     decrease the time to healing. The ability of a patient with non-union (lack of bone healing     after 3 months post operation) to return to the work force and to normal activities more     quickly not only has a good financial impact on society (community), but also improves     over-all physical and mental well-being of the patients.      Infuse is a synthetic bone morphogenic protein which means it has the ability to help your     bone to form and heal if inserted in the fracture site. Infuse may be the first     commercially available product approved by Health Canada to accelerate the healing of long     bone non-unions requiring surgical intervention.      Although the safety and efficacy of Infuse has been demonstrated through numerous     pre-clinical studies, further human clinical trial is needed to evaluate the safety and the     power to produce effects of this product particularly with respect to non unions of long     bones. The purpose of this study is to evaluate the safety and the power to produce effects     of Infuse implanted during treatment of long bone non unions to reduce later surgeries     required to augment the healing process and to accelerate the time to healing.      Given this, the orthopaedic community has planned this study in order to scientifically     establish the most effective treatment method to restore function after this type of injury.   "
229482|NCT00856492|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing.     Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells     found in bone marrow or peripheral blood and may help the immune system recover from the side     effects of chemotherapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth     in different ways. Some find tumor cells and kill them or carry tumor-killing substances to     them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may     also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving these     treatments before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed. It is not yet known which treatment regimen is more effective in     treating women with breast cancer.      PURPOSE: This randomized phase II trial is studying paclitaxel albumin-stabilized     nanoparticle formulation, doxorubicin, cyclophosphamide, and pegfilgrastim to compare how     well they work when given with or without bevacizumab in treating women with inflammatory or     locally advanced breast cancer.   "
229483|NCT00856505|"     In stem cell transplantation as treatment for malignant diseases, calcineurin inhibitors like     cyclosporine A are commonly used to prevent tissue destruction (GvHD) by activated donor     immune cells. The hypothesis for this study is, that replacing calcineurin inhibitors by     everolimus and mycophenolate as GvHD prophylaxis not only reduces toxicity of the treatment     but also improves tolerance induction of the donor T cells toward the host, eventually     increasing the safety of stem cell transplantation.   "
229494|NCT00856648|"     The present study aims to evaluate the relationship between the level of SCI and the     impairment of Colonic transit time (CTT) and Total transit time (TTT) by using the SmartPill     device. The SmartPill, an FDA approved device, is a wireless capsule that is ingested and     transmits values for GI pH, temperature, and pressure as it travels throughout the digestive     system. The SmartPill can also be used to assess CTT and TTT. In comparing values for CTT,     TTT, pH, temperature, and pressure in SCI patients to healthy, able-bodied controls, the     SmartPill device may provide valuable insight into the pathophysiological implications of SCI     on GI function. This information may allow medical professionals to provide more effective     plans of care for this population, subsequentially enhancing quality and quantity of life.     The SmartPill device may also provide a less invasive alternative to assessing these     variables, compared to traditional modalities.   "
249547|NCT01122550|"     The purpose of this study is to evaluate its reproducibility of overactive bladder symptom     score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.   "
229484|NCT00856518|"     Respiratory difficulty is one of the primary factors leading to death in patients with     Parkinson's Disease (PD) and Multiple Sclerosis. Both diseases are progressive degenerating     diseases that cause difficulties in breathing, airway protection and swallowing. Patients     with PD and MS typically become sedentary and lose endurance, maximal fitness levels and     overall pulmonary function. Much of the research focus has been on the motor symptoms of PD     and MS yet the pulmonary and swallowing complications are perhaps ultimately the most     important disability as the diseases progress. The inability to generate adequate respiratory     pressure is responsible for reduced cough magnitudes and cough response times. Cough is     critical for the clearance of foreign materials in the airway helping to reduce infiltration     of bacteria and subsequent respiratory infection. With reduced cough function an increased     risk for pulmonary disease occurs due to a reduced ability to protect the airways. There are     a number of promising outcomes from an expiratory strength-training program. By increasing     expiratory muscle strength and expiratory pressure generation, effective breathing, clearance     of the airway, and improved swallowing can occur. These explicit outcomes are predicted based     on our experience with the use of an innovative device-driven, home-based expiratory strength     training program focused on the expiratory muscles of respiration. This project focuses on     following patients with PD and MS for an initial 5 weeks of strength training and them     testing the outcome of a caregiver program for maintaining treatment effects.   "
229485|NCT00856531|"     The Möbius syndrome constitutes a congenital disorder classically caused by genetic and     environmental factors. The clinical manifestations include lesion of the facial and abducens     nerves associated with limb malformations specially club foot. The speech-language     manifestations include compromise of oral and deglutition, speech and language functions,     secondary to cranial nerves lesions and mental retardation. The language compromise in this     disorder is still not well known. In this way, the main objective of this study is to     characterize the oral language in a population of fifteen subjects with Möbius syndrome with     age ranging from two to thirteen years old, from both sexes, seen in one of the three main     center for genetic diagnosis in the state of Ceará. The present work is a descriptive study     of a cross-sectional design conducted from February to December/2002, using a clinical     evaluation of language components including morphology, syntax, semantics and pragmatics. The     investigators identified exclusive speech involvement in 20,0% of the subjects, language     disturbance in 46,7%, speech and language disturbance in 13,3% and oral language involvement     in 26,7%. The investigators conclude that the language disturbance in the Möbius syndrome     presents with a variable compromise of all oral language components. The delay in     linguistical development, incomprehensive speech and the deficit of constructions of     sentences and narrations are constant.   "
229486|NCT00856544|"     This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg     BID is safe and effective when used in combination with a variety of traditional disease     modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to     confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that     were observed in the Phase 2 rheumatoid arthritis studies.   "
229487|NCT00856557|"     This study assessed whether a medical education intervention improves the quality of medical     decision making in the care of patients with complex psychosocial -- or contextual -- needs     that are essential to address when planning their care. A group of internal medicine     residents were randomly assigned to participate in the seminar and practicum and then they,     along with a control group that had not participated, were assessed for the quality of their     clinical decision making and its impact on patient care. The study also assessed whether     contextualization of care is associated with better patient health care outcomes   "
229491|NCT00856609|"     Background:        -  Obesity can lead to a number of health problems, including diabetes, heart disease,          stroke, low back pain, fatty liver disease, and osteoarthritis. The medical treatments          currently available for obesity are limited.        -  Exenatide is an injectable medication approved for treatment of Type 2 diabetes that          causes weight loss in some diabetic subjects. If exenatide works for weight loss in          nondiabetic persons is not known.      Objectives:        -  To determine whether nondiabetic obese individuals treated with exenatide as compared          with those treated with placebo will lose a greater amount of weight and have body          composition changes over a 24-week period, and whether the loss and body composition          changes will be maintained during a 24-week extension period.        -  To determine whether exenatide leads to a decrease in food intake.        -  To determine whether change in caloric intake correlates with exenatide-induced changes          in stomach emptying time.        -  To determine the effects of exenatide on energy expenditure.        -  To determine the effects of exenatide on carbohydrate versus fat use by the body for          energy needs.        -  To determine the effects of exenatide on activity levels.        -  To determine whether exenatide alters hormonal levels, and the association of any          changes with energy intake and expenditure, future weight loss, and percent body fat          changes.        -  To determine whether exenatide alters responses to behavioral testing via questionnaires          specifically addressing dietary restraint and stress-related eating behaviors and the          relationship of any changes to food intake, hormone levels, weight loss, and fat loss.        -  To assess the tolerability and safety profile of exenatide in nondiabetic obese          subjects.      Eligibility:        -  Nondiabetic men and (premenopausal) women between the ages of 18 and 55 years who have a          body mass index greater than 30 kg/m(2) and live in the Phoenix, AZ area.      Design:        -  Participants will be admitted for an initial 16-day period to the research unit, during          which the following will occur:        -  Instructions on lifestyle changes to promote weight loss        -  Questionnaires to determine eating-related behaviors and attitudes toward food        -  Laboratory testing to determine glucose tolerance, body composition, stomach emptying          time, hormone levels, energy expenditure and food intake both before and after starting          the study medication        -  Instructions on self-injecting exenatide or placebo via a medication pen        -  Instructions on the use of blood glucose monitors and logs        -  Following release, participants will self-administer a set dose of either exenatide or a          placebo 2 times per day for 24 weeks. Participants will not know whether they are          receiving exenatide or placebo.        -  Outpatient visits occur weekly for the first 4 weeks and then once every 4 weeks, during          which weight loss, compliance with self-medication, side effects, and lifestyle          modifications will be assessed.        -  Participants will be readmitted to the metabolic unit during the 24th week of the study,          during which the studies from the initial stay will be repeated.        -  Participants wishing to continue into the 24-week open-label extension period will be          seen as outpatients as described in the initial part of the study.   "
229492|NCT00856622|"     The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol     (PhXA41) has better IOP lowering effect than the individual monotherapies.   "
229493|NCT00856635|"     The main objective of the study is to determine whether glatiramer acetate 20 mg once daily     reduces the amount of axonal loss in the optic nerve after a first event of acute optic     neuritis compared to placebo patients and to generate data supporting the potential     neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.   "
229495|NCT00856661|"     The purpose of the study is to determine whether desmoteplase is effective and safe in the     treatment of patients with acute ischaemic stroke when given within 3 to 9 hours from onset     of stroke symptoms.   "
229496|NCT00856674|"     The purpose of this study is to evaluate the safety of several dose levels of CCL2-LPM in     patients with IgA Nephropathy who have high levels of protein in the urine.   "
229497|NCT00856687|"     PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial     allergen challenge on lung function and hence provide proof of mechanism for this agent.   "
229498|NCT00856700|"     Glucagon-like peptide 1 (GLP-1) is an intestinal peptide hormone secreted in a     nutrient-dependent manner that stimulates the pancreatic beta cells to secrete more insulin     in response to the same amount of blood glucose. In patients with Type 2 diabetes, GLP-1     secretion is lower than normal, thus suggesting that the hormone may contribute to the     pathogenesis of the disease. Whether infusion of GLP-1 affects endothelial function and     glucose uptake in humans has never been investigated. In the current proposal, the     investigators hypothesize that GLP-1 administration might ameliorate endothelial dysfunction     in patients with metabolic syndrome. To test this hypothesis, the investigators will evaluate     the acute effects of GLP-1 in the forearm circulation of patients with metabolic syndrome     during local hyperinsulinemia by use of the forearm perfusion technique.   "
229499|NCT00856713|"     A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age,     gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)   "
229500|NCT00856726|"     The investigators aim to study potential racial differences in renal phosphorus handling by     provocatively testing urinary phosphorus excretion using parathyroid hormone infusions in     healthy white volunteers compared to healthy black volunteers.   "
229501|NCT00856739|"     Healthy adults aged 20-60 of varying weights will participate in this minimally invasive     study. There is one 4-hour appointment for which subjects are paid $120. The tests involve: 1     tube blood draw, 1 gait test (motion capture) and 1 MR of both knees.   "
229502|NCT00856752|"     A study in healthy volunteers to determine whether different drugs metabolised by the liver     have any effects on how NRL972 is processed within the body.   "
229503|NCT00856765|"     The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may     benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent     combination without impairing the process of normal vascular healing and endothelial     function.      The goals of this study are:        1. To compare 6-month angiographic outcome after primary angioplasty using drug eluting          balloon/bare metal stent combination versus drug eluting stent versus bare metal stent.        2. To compare stent apposition and stent endothelialization after primary angioplasty using          drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.        3. To compare coronary endothelial function after primary angioplasty using drug eluting          balloon/bare metal stent versus drug eluting stent versus bare metal stent.   "
229504|NCT00856778|"     This study is a multi-center, global study that will assess the effectiveness and patient     satisfaction of the male incontinence sling 12 months after implant as well as the safety     profile of the product.   "
229518|NCT00856960|"     This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH     clearance, PC MRA and ASL MRI methodologies.   "
229506|NCT00856804|"     INDICATION:      Patients with chronic hepatitis C, genotype 1 and non-responders to standard treatment for     hepatitis C.      OBJECTIVES:        1. ascertain the rate of sustained response in patients with hepatitis C, genotype 1 with          peginterferon + ribavirin resistance.        2. To know the response rate in 12 weeks        3. Describe the tolerance and safety of thalidomide in combination with peginterferon and          ribavirin.      DESIGN OF TEST Pilot Study:      The single arm study will:      1. Thalidomide 200 mg and peg-interferon alfa 2b (based on weight: 50-120 mcg / week) +     ribavirin (based on weight: 1000-1200mg / day)      Be tracked for 24 weeks after treatment.      Suspended treatment of 12 weeks in patients who have failed a drop of HCV RNA> 2 log.      Patients who have been suspended for any reason, the treatment will be followed during 24     weeks, to assess safety parameters.      SUBJECT NUMBER: 10   "
229507|NCT00856817|"     The purpose of this study is to determine whether heme oxygenase 1 induction by heme arginate     treatment is of influence on adenosine induced vasodilation in healthy individuals.   "
229508|NCT00856830|"     Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of     lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two     thirds of new cases and is generally considered sensitive to chemotherapy, despite a median     time to progression of 4 months. SCLC is one of the most aggressive and lethal types of     cancer, with a median survival of 9 months (range 7-11 months) in patients diagnosed with     extensive disease. Overall, the majority of patients with SCLC die in less than 2 years     (2-year survival rates generally less than 10%), and the 5-year survival rate is 2.3% for     patients with extensive disease. The regimen of etoposide in combination with a platinum     (cisplatin or carboplatin) is generally considered the standard of care although a recent     Phase III trial suggests improved survival with the combination of cisplatin/irinotecan.     Further evaluation of new agents in combination regimens attempting to overcome the intrinsic     drug resistance seen in extensive-stage SCLC is warranted attempting to improve survival and     achieve palliation of disease-related symptoms.   "
229509|NCT00856843|"     To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before     colonoscopic examination in adult subjects.   "
229510|NCT00856856|"     The purpose of this study is to assess the safety and performance of the BVS Everolimus     Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de     novo native coronary artery lesions located in two different major epicardial vessels.      Currently in development at Abbott Vascular. Not available for sale in the United States.   "
229511|NCT00856869|"     The study was conducted to describe and compare the plasma pharmacokinetics of NRL972     administered after a standard meal and while fasted in patients with hepatic cirrhosis     (Child-Turcotte-Pugh [CTP] class A-C), NASH, young and elderly healthy males, and young and     elderly healthy females, to assess the effects of liver dysfunction, gender, age and prandial     intestinal hyperaemia on the clearance of NRL972. In addition, the study was to provide     information on the safety and tolerability of repeated intravenous doses of NRL972 in these     populations.   "
229512|NCT00856882|"     The investigators propose to perform a double-blind, randomized placebo-controlled trial to     examine the hypothesis that soy protein with isoflavones could improve glycemic control,     insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with     prediabetes.   "
229543|NCT00857285|"     The purpose of this study is to determine the efficacy and safety of oral administration of     olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.   "
229513|NCT00856895|"     The purpose of study is to measure the quality of life (QOL) of patients pre and post kidney     transplant by asking them to fill out a survey. Patients will be asked to fill out the survey     before transplant, 3 months post-transplant, and 1 year post-transplant to see how the     transplant relates to any progression in quality of life.      QOL will be assessed to correlate the quality of life and aspects of renal function     prospectively at pre and post-transplant across all ethnicities and variances of donor types     at three time points. First, there will be a prospective assessment of QOL in the Hispanic     and Non-Hispanic kidney recipients before and after transplant at NMH and Colombiana de     Transplantes. Second, there will be an assessment of the Hispanic kidney patients that have     been transplanted over the last 10 years at NMH and Colombiana de Transplantes, in a     cross-sectional fashion. Third, there will be a comparison and determination of the     differences in QOL in the Hispanic population before and after the Hispanic Transplant     program was initiated in November 2006. Lastly, there will be an assessment of the social     impact of the services that NMH's Hispanic Transplant Program provides to patients.      The questionnaires completed by the subjects at NMH will be the same questionnaires completed     by the subjects in Colombia. The data obtained from Colombiana de Transplantes will be     de-identified data and provided to us via a password protected excel file delivered to the     principal investigator electronically.   "
229514|NCT00856908|"     The purpose of this study is to assess the 1 month safety and tolerability after multiple     oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Insulin   "
229515|NCT00856921|"     The AAAS gene has been known to cause achalasia, alacrima, adrenal abnormalities and a     progressive neurological syndrome. A considerable proportion of achalasia patients have been     known to show alacrima (decreased secretion of tears). However, the genetic mechanism between     achalasia and alacrima has not been defined yet. The investigators postulated that some     proportions of early-onset achalasia could be correlated with AAAS gene; thus, the     investigators aimed to investigate the relationship between the AAAS gene and early-onset     achalasia.   "
229516|NCT00856934|"     This prospective randomized trial evaluated the impact of autologous keratinocytes suspended     in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that     the treatment would speed and improve wound healing.   "
229517|NCT00856947|"     The aim of this study is to prevent asthma symptoms (recurrent wheeze) in childhood by     supplementation with high dose vitamin D to the mother during pregnancy. Participants are     mothers and children of the ABC (Asthma Begins in Childhood) cohort. Mothers are recruited     during pregnancy and receive daily supplement with 2400 IU of Vitamin D3 or placebo from week     24 og gestation to 1 week after delivery. In addition all mothers are advised to take the     recommended dose of 400 IU vitamin D daily. The mothers in ABC also participate in an     interventional trial with fish oil supplementation, and the vitamin D randomization is     stratified by fish oil treatment group. The child is followed with acute and planned vits at     the research unit, and wheeze is diagnosed according to predefined algorithms.   "
229519|NCT00856973|"     A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared     to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age,     inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.   "
229520|NCT00856986|"     This trial is conducted in Europe and North America. The aim of this clinical trial is to     assess and compare the effect of insulin detemir in combination with liraglutide and     metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will     continue their own pre-trial metformin treatment during the trial.   "
229521|NCT00856999|"     The purpose of this study is to see if consistent treatment with Botox will lead to longer     lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug     Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this     study a different dosing schedule of Botox injections will be used to see if the effects of     the Botox treatment last longer than the effects of the standard injection regimen.   "
229522|NCT00857012|"     Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront     or following two to three years of tamoxifen treatment (switch) for at least three and not     more than six months prior to offering an individual participation in this program. Treatment     should follow local therapy guidelines and standard practice. Treatment decisions for     patients participating in this study including assessments or supportive therapy during     follow-up visits will also follow guidelines and remain independent of the program.   "
229523|NCT00857025|"     RATIONALE: Biological therapies, such as beta-glucan, may stimulate the immune system in     different ways and stop tumor cells from growing.      PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan in     treating patients with locally advanced or metastatic non-small cell lung cancer.   "
229524|NCT00857038|"     COPD is a progressive pulmonary disease that is characterized by an inflammatory process in     the airways and the lungs which leads to progressive airway obstruction. The inflammation is     associated with tissue loss and remodelling. The investigators hypothesized that doxycycline     reduces neutrophilic airway inflammation in patients with COPD. Therefore the investigators     will conduct a randomized trial of doxycycline in 30 patients.   "
229525|NCT00857051|"     We are conducting a study to look interventions that may reduce stress in the postpartum     period for first- time mothers. One of these interventions is an educational film that     describes the common stressors that first-time parents go through in the early postpartum     period. The other is a hotline service that women can call at anytime during the first 3     months postpartum to ask about problems she or the baby may be experiencing.   "
229526|NCT00857064|"     Non-interventional study aiming to provide data on the subjective effects of antipsychotic     medication assessing subjective well-being and global functioning of patients with     Schizophrenia under antipsychotic medication. Moreover it aims to assess their adherence to     the treatment and will investigate whether there is any correlation of these factors with the     clinical condition of these patients.   "
229527|NCT00857077|"     Evaluation of the safety and effectiveness of malaria intermittent chemotherapy and iron     supplementation delivered through Expanded Programme on Immunisation vaccination clinics.   "
229528|NCT00857090|"     The objectives of the study are to assess the systemic exposure, safety and efficacy of three     concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper     urinary tract stones.   "
229529|NCT00857103|"     This interdisciplinary international research collaboration will test effects of Choice, a     computer-assisted, interactive support system designed to help cancer patients communicate     their symptoms and preferences, and clinicians in incorporating this information into patient     care. In this pretest-post test clinical trial with 200 leukemia and lymphoma patients we     will: 1) Test effects of Choice when integrated into routine clinical practice on:     patient-provider communication, documented patient care, anxiety and patient satisfaction; 2)     analyze relationships among the above variables and explore differences in these     relationships between groups; 3) analyze group differences in communication style in terms of     instrumental and affective behavior, content, participation, initiative and person addressed;     and 4) investigate the extent of the time requirements when using Choice in clinical     practice, perceived usefulness and ease of use.   "
229530|NCT00857116|"     The purpose of this study is to investigate whether treatment against intestinal helminths in     patients with pulmonary tuberculosis undergoing chemotherapy could improve the clinical     outcome by enhancing host immunity.   "
229531|NCT00857129|"     Prospective evaluation of birth complication in three differently staffed and equipped units     in the same hospital.   "
229532|NCT00857142|"     The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone     hydrochloride extended release tablets (Sandoz) with Opana extended release oxymorphone     hydrochloride tablets.   "
229533|NCT00857155|"     Purpose: In patients with coronary artery disease, aspirin and Plavix are used increasingly     to prevent the formation of blood clots in the coronary arteries. These drugs exert their     beneficial effects by irreversibly blocking platelets, the compounds found in blood     responsible for clotting after an injury or during a heart attack. However, these effects     also place patients at increased risk for bleeding after coronary artery bypass surgery.     Therefore, it is currently recommended to withhold Plavix therapy for 5 days before     undergoing surgery in order to reduce the incidence of bleeding. However, it has been     repeatedly shown that Plavix exerts variable effects on different patients, which may be     partially explained by poor absorption, drug-drug interaction, and by variations in     deoxyribonucleic acid (DNA) which constitutes your genes. In addition, the time required for     platelets to regain function after Plavix treatment has been shown to vary between patients.     Therefore, by measuring platelet function, it may be possible to determine the optimal amount     of time required to withhold Plavix before undergoing bypass surgery, which may improve rates     of bleeding following the procedure. The purpose of this study is to classify patients into     groups based on platelet function in order to define the ideal time period for delaying     surgery. By analyzing the amount of time required for platelet recovery, it is expected that     surgery-related bleeding will decrease without increasing the risk of blood clot formation.      Eligibility: Approximately 200 patients requiring CABG will be enrolled at Sinai Hospital,     which is the only site where this study is being conducted.      To be eligible you must:        -  Be able to provide written informed consent.        -  Be between the ages of 18-85 and require CABG.        -  Currently be on aspirin therapy (81-325mg).   "
229553|NCT00857428|"     The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone     hydrochloride extended-release tablets (Sandoz) with Opana extended release oxymorphone     hydrochloride tablets.   "
229710|NCT00853138|"     The purpose of this study is to develop and evaluate the feasibility and effectiveness of a     web-based (i.e., internet) treatment approach for providing psychological treatment to reduce     pain and improve functioning in children and adolescents with chronic pain.   "
229534|NCT00857168|"     Testosterone replacement treatment is the most effective way of treating hypogonadism in men.      Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study     will evaluate the impact of application of antiperspirant and deodorant on absorption of     testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).      The study also aim to evaluate the impact of washing the application site on the absorption     of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous     solution).   "
229535|NCT00857181|"     The aim of this study is to test whether the oscillation of cytokine concentrations in serum     is able to predict the development of infection in patients with liver cirrhosis.   "
229536|NCT00857194|"     Coronary heart disease (CHD) is a leading cause of death in the spinal cord injured (SCI)     population, occurring at younger ages than in the able-bodied population. Conventional risk     factors for CHD include high concentrations of low-density lipoprotein (LDL), low     concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), smoking history,     and family history. Other factors that may influence progression of CHD include C-reactive     protein (an inflammatory marker), and fibrinogen (a pro-coagulant marker). Individuals with     SCI with longer duration and greater completeness of injury are more likely to have     significantly worse carbohydrate tolerance compared to other neurological deficit subgroups.     Muscle atrophy after SCI is associated with increased insulin resistance. Prolonged     inactivity has been shown to be associated with hyperinsulinemia and impaired glucose     tolerance. Body composition changes after SCI to indicate significantly more total body fat     mass and percent fat and less lean mass compared to able-bodied individuals. Carotid     intima-media thickness is correlated with atherosclerosis progression and abdominal     adiposity. Individuals with abdominal adiposity are at a higher risk for CHD, DM,     hypertension, insulin resistance, and dyslipidemia. Abdominal adiposity and insulin     resistance are contributors to postprandial lipemia, which may be a more sensitive indicator     of CHD risk and progression.      The purpose of this study is to determine the prevalence of conventional risk factors by     assessing the 10-year risk for CHD, and identify emerging risk factors for CHD in the spinal     cord injured population. Subjects will have the option to participate in a high fat meal test     to determine postprandial lipemic responses. Knowledge of this information may be able to     detect and prevent future cardiovascular events related to CHD.   "
229537|NCT00857207|"     Enhanced Goal Management Training (GMT) is a 10-week group or individual therapy that teaches     strategies to improve an individual's ability to complete everyday tasks. This research study     will test the effect of GMT on 36 OEF/OIF Veterans compared to a control group of 16 OEF/OIF     Veterans receiving a Brain Health Workshop. The results will provide information to conduct     future research with a larger group of patients or to identify which patients demonstrate     more benefit from the training.   "
229538|NCT00857220|"     A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age,     inclusive) and adolescents (12 17 years of age, inclusive) with attention     deficit/hyperactivity disorder (ADHD) associated insomnia.   "
229539|NCT00857233|"     The primary objective of the study was to examine the safety and tolerability of memantine in     outpatients with moderate to severe Alzheimer's Disease.   "
229540|NCT00857246|"     This study intends to evaluate the feasibility and treatment efficacy of adding an antibody     blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven     efficacy developed at New York University.   "
229541|NCT00857259|"     The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination     with Lucentis in patients with neo-vascular age related macular degeneration (AMD)   "
229542|NCT00857272|"     To compare the safety and efficacy of 2 different bowel cleansing preparations prior to     colonoscopy in adult subjects.   "
249548|NCT01122563|"     This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before     and after solifenacin treatment to OAB subjects.   "
229544|NCT00857298|"     Obese HIV-positive women with Metabolic Syndrome (HIV-MS) and obese HIV-negative women with     Metabolic Syndrome will be studied before and after achieving moderate (6%-8%) diet-induced     weight loss. The investigators hypothesize that health markers will improve in both groups     but that the improvement will be blunted in the women with HIV-MS.   "
229545|NCT00857311|"     A Study to assess the general safety and tolerability of the administration of a 3-dose     prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis     C virus infection.   "
229546|NCT00857324|"     The purpose of this study is to determine whether the association of ZMP is safe and provides     benefits in patients with relapsed/refractory MM.   "
229547|NCT00857350|"     HIV drug resistance presents a significant public heath problem. This proposal is designed to     explore the association between ongoing illicit drug use and the prevalence of HIV drug     resistance among HIV+ opioid dependent patients receiving opioid agonist treatment with the     following hypotheses:        1. Hypothesis 1: The prevalence of HIV drug resistance will range between 10% and 30%.        2. Hypothesis 2: Patients with evidence of ongoing illicit drug use will be more likely to          have HIV drug resistance.   "
229548|NCT00857363|"     The protocol described herein is designed to provide clinical evidence of the substantial     equivalence of SmartPill GI Monitoring System (SP) to the Sitzmarks (Konsyl Pharmaceuticals,     Easton, MD) radio-opaque markers (ROM). The trial will enroll symptomatic subjects who meet     Rome III criteria (1) for chronic functional constipation.   "
229549|NCT00857376|"     Heart disease is the most common cause of death in the United States and it is commonly found     in people with diabetes and high cholesterol. Inflammation is one mechanism by which diabetes     and elevated cholesterol damage blood vessels. Inflammation can be increased by oxidative     stress. This study will see if Alpha Lipoic acid, a potent antioxidant and over the counter     product, reduces blood levels of markers of oxidative stress and inflammation when compared     with placebo. Placebo is a substance that looks like the real product, but contains no active     product.   "
229550|NCT00857389|"     The goal of this clinical research study is to learn if thiotepa, busulfan, and clofarabine,     when given before an allogeneic (bone marrow , blood, or cord blood cells) or haploidentical     (bone marrow) stem cell transplantation can help to control cancers of the bone marrow and     lymph node system. The safety of this treatment will also be studied.   "
229551|NCT00857402|"     The purpose of this study was to investigate if adjuvant treatment with arginine (the     substrate for nitric oxide production) rich food supplements could improve clinical outcome     in patients with smear positive tuberculosis by affecting nitric oxide production.   "
229552|NCT00857415|"     The study is designed to test the relationship between measurements of brain amyloid using     florbetapir F 18 PET imaging and true levels of amyloid by dissection of the brain at     autopsy. Amyloid in the brain is a key feature of Alzheimer's Disease (AD).   "
229554|NCT00857441|"     The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes     of:        1. Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in          comparison to dilation with a standard balloon prior to the implant of the Liberty Bare          Metal Stent in bifurcation lesions (with side branch involvement).        2. Comparison of the results above with the results of using a standard balloon prior to          provisional T-stenting with the Paclitaxel-eluting stent TaxusTM LibertéTM.   "
229555|NCT00857454|"     Testosterone replacement treatment is the most effective way of treating hypogonadism in men.     Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study     will assess the occurrence of skin safety events for a further two months of continuous use     of the Testosterone MD-Lotion® (cutaneous solution) after completion of the MTE08     (NCT00702650) trial.   "
229556|NCT00857467|"     This is a healthy volunteer three-way crossover study. A total of 12 subjects will receive     three single administrations of 1 g rectal suppositories (containing either 5 mg NRL001, 10     mg NRL001 or matching placebo), with a washout period of at least 7 days between dosings. A     further 12 subjects will receive three single administrations of 2 g rectal suppositories     (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), again with a 7 day washout     period between dosings. The pharmacodynamic response, pharmacokinetics and safety profile     will be determined.   "
229557|NCT00857480|"     A study in healthy volunteers to determine whether different drugs metabolised by the liver     have any effects on how NRL972 is processed within the body.   "
229558|NCT00857493|"     A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate Safety and     Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old     Vaccinia-Experienced Subjects   "
229559|NCT00857506|"     The primary objective of this protocol is to determine if brain amyloid imaged with     florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment     during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and     Alzheimer's disease.      Hypothesis 1: The probability a subject will experience progressive cognitive impairment     within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated     amyloid positive compared to subjects whose PET scan was rated amyloid negative.      The secondary objective is to determine the stability, over 36 months of a clinical     diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET.      Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated     as amyloid positive.   "
229560|NCT00857519|"     Over the past 15 years, intravenous chemotherapy has become the most popular conservative     (eye-saving) method for retinoblastoma treatment because it is often effective and usually     safe. In recent years, there has been much interest in providing highly focused (focal)     chemotherapy to a diseased organ including the liver, brain, and eye. With focused     chemotherapy, the chemotherapy drugs are injected directly into the ophthalmic artery (the     artery that supplies blood to the eye). A benefit of focal chemotherapy delivery is that it     decreases the chance of toxicity to other organs such as bone marrow suppression (causing low     blood counts) and the development of other cancers in the future.   "
229561|NCT00857532|"     The primary aim of this study is to compare regional amyloid burden in Parkinson's disease     (PD) to normal control subjects. We hypothesize that there will be significant differences in     overall amyloid burden in PD patients compared to age-matched normal controls.   "
229562|NCT00857545|"     This randomized phase III trial studies OPT-821 and vaccine therapy to see how well they work     compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian     tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still     be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in     different ways and stop tumor cells from growing. Vaccines may help the body build an     effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more     effective with or without vaccine therapy in treating patients with ovarian epithelial     cancer, fallopian tube cancer, or peritoneal cancer.   "
229563|NCT00857558|"     A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to     investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes   "
229564|NCT00857571|"     The study compares the plasma concentrations of PF-02413873 after administration of several     doses as suspension and as tablets   "
229565|NCT00857584|"     Prospective, open-label, controlled (active comparator), randomized study of 8 weeks     follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR)     versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at     stable and clinically therapeutic blood levels) in the treatment of the adult bipolar     depression. This multicentric study will be featured in two sites in Spain.   "
229566|NCT00857597|"     The study objective is to evaluate the relative merits, safety and effectiveness of Transoral     Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump     Inhibitors (PPIs).   "
229567|NCT00857610|"     Topical therapy with retinoids is the only proven medical therapy for aged/photoaged human     skin. However, topical therapy with retinoids often result in unwanted cutaneous dermatitis,     including erythema and scaling. The reseachers intend to investigate the dose, frequency of     use, and time dependence of topical retinol-induced dermatitis. The researchers intend to     evaluate retinoid-induced dermatitis biochemically, including retinol regulation of retinoid     responsive genes that control retinoid metabolism and serve as markers for retinoid     bioactivity. The researchers will also investigate the role of EGF receptor pathway in     retinoid-induced dermatitis.   "
229568|NCT00857623|"     The purpose of this study is to investigate if AZD2066 can relieve the pain arising from     painful diabetic neuropathy compared to placebo.   "
229586|NCT00857857|"     The study will measure the early and late asthamtic response using an allergen challenge.     This study will evaluate the safety and patients tolerance to repeat inhaled doses of     GW870086X using a number of clinical and biological markers.   "
229711|NCT00853151|"     Test the safety, tolerability and improvement of blood sugar control with combination therapy     in individuals with Type 2 Diabetes.   "
229899|NCT00861393|"     The purpose of the study is to determine whether or not a brief psychological treatment     called cognitive behaviour therapy will help people who have suffered a spinal cord injury to     cope better with their current circumstances.   "
229569|NCT00857636|"     The long-term goal of this study is to build a sustainable,community-based outreach program     using Korean American community health workers (CHWs) to promote breast and cervical     screening among Korean American women, thereby reducing related morbidity and mortality. The     study is designed to determine the effectiveness of a health literacy-focused tailored breast     and cervical cancer control intervention delivered by CHWs.      The investigators hypothesized that, compared to KA women in the delayed intervention group,     KA women who receive a health literacy-focused CHW intervention will demonstrate: (1) higher     levels of adherence to screening for breast and cervical cancer, (2) greater levels of health     literacy, (3) higher levels of breast and cervical cancer knowledge, and (4) improve     decisional balance.   "
229570|NCT00857649|"     The primary objective of this study is to examine the efficacy of memantine on cognition and     behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type.   "
229571|NCT00857662|"     Test whether AVMs treated with Onyx is equivalent to treatment with n-BCA. Success is defined     as an AVM size reduction greater than 50%   "
229572|NCT00857675|"     The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in     treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.   "
229573|NCT00857688|"     To evaluate the efficacy of the product Bismu-Jet ® (bismuth tartrate and sodium, neomycin     sulfate and procaine hydrochloride) produced by EMS S / A compared to placebo in reducing the     signs and symptoms resulting from UAR in patients of both sexes, with age over 12 years.   "
229574|NCT00857701|"     The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for     knee flexion contracture following a total knee arthroplasty.   "
229575|NCT00857714|"     The purpose of this study is to establish the utility of lapatinib in the treatment of DCIS,     particularly ER-negative DCIS.   "
229576|NCT00857727|"     Emergence delirium (ED) from general anesthesia posts risk and harm to pediatric population     undergo general anesthesia. The purpose of the study is to compare the use of dexmedetomidine     versus placebo in reducing the incidence and severity of ED in a pediatric neurosurgical     population.   "
229577|NCT00857740|"     The purpose of this study is to investigate whether education about the neurophysiology of     pain is able to improve central pain inhibition in patients with Fibromyalgia.   "
229578|NCT00857753|"     Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch     transdermal delivery system.   "
229579|NCT00857766|"     The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary     Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure     associated with risk of heart disease.   "
229580|NCT00857779|"     The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking     factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ   "
229594|NCT00857961|"     Testosterone replacement treatment is the most effective way of treating hypogonadism in men.     Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study     will evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also     assess safety of the product.   "
253880|NCT01177930|"     The purpose of this study is to evaluate the influence of the type of feeding in the first     year of life on the behavior and health-related quality of life at 6-8 years of age.   "
229581|NCT00857792|"     The investigators goals are:        1. to develop software for quantitative volumetric analysis of myocardial perfusion from          MDCT images        2. to test its ability to accurately determine the presence, location, extend and severity          of perfusion abnormalities in agreement with conventional diagnostic techniques (ICA and          MPI) in patients with normal and abnormal coronary arteries and/or perfusion patterns        3. to test this approach in patients undergoing vasodilator stress tests with MDCT imaging          in combination with the new vasodilator stress agent Regadenoson.   "
229582|NCT00857805|"     Patients with liver tumor burden that exceeds Milan criteria are considered to receive one of     the following locoregional treatments: transarterial chemoembolization (TACE), radiofrequency     ablation (RFA), percutaneous ethanol injection and proton beam radiation (PBR). The goals of     these treatments are to control tumor growth, to downstage tumor size to meet Milan criteria,     and to improve survival. Patients who exceed the Milan criteria benefit from tumor     downstaging as a result of treatment. Patients who meet Milan criteria benefit from tumor     control to bridge them to liver transplantation. TACE is considered the most common     locoregional treatment that is used to treat hepatocellular carcinoma (HCC). Proton beam     radiotherapy has been used in treating HCC in a few centers across the globe. Phase I and II     trials showed a satisfactory safety and efficacy results. Loma Linda University Medical     Center is one of these pioneering centers that use proton beam as a treatment for HCC. This     is the first randomized trial in the medical field that will compare head-to-head the     efficacy of TACE versus proton beam in treating HCC patients.   "
229583|NCT00857818|"     The purpose of this study was to determine whether patients with schizophrenia,     schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a     larger decrease in fasting non-high density lipoprotein (non-HDL) cholesterol levels with     aripiprazole than with their current atypical antipsychotic treatment (olanzapine,     risperidone, or quetiapine).   "
229584|NCT00857831|"     Vitamin D aids in the body's ability to absorb calcium, it is a vital component in bone     formation and break down. Reduced levels of vitamin D can indicate a vitamin deficiency and     may depress serum calcium levels. The following is a list of common causes of vitamin D     deficiency: lack of dairy products, alcohol usage, elderly, lack of exposure to sunlight,     individuals with reduced mobility, GI malabsorption problems, dark complexion, severe liver     damage, and renal failure. Many of these factors can be found in individuals with spinal cord     injury. SCI results in disuse bone loss after acute injury, which continues with duration of     injury. The goal of this study is to determine the effects of vitamin D and calcium     supplements on calcium metabolism and vitamin D deficiency in individuals undergoing     functional electrical stimulation (FES) stand retraining (SRT).   "
229585|NCT00857844|"     The purpose of this study is to determine the relationship between genomic variants of     components of the renin-angiotensin system and the development of kidney problems due to     Calcineurin-inhibitors post liver transplant.Also the investigator will evaluate the     relationship between chronic renal failure post liver transplant and the risk of death. A     sample of blood and urine wil be examined to see how the patient's genes are arranged in     order to determine the difference in genes between people which may explain who will develop     chronic renal failure after having received a liver transplant.      The results may help us classify patients according to their risk and allow us to target     their treatment to their individual need. In addition, it may ultimately lead to treatments     that slows or prevents the development of chronic rejection.   "
229587|NCT00857870|"     Comparison of efficacy and safety of glargine insulin and metformin as first line drug of     patients insufficiently treated with lifestyle intervention. So far treatment also algorithm     with lifestyle and metformin has not been evaluated in patients with type 2 diabetes and     HbA1C greater or equal 7 % and lower than 8.1%.Besides HbA1C postprandial glucose excursion     and glycemic variability as determinants of oxidative stress will be measured by continuous     glucose measurement(CGM). Further more CGM will reveal risk of hypoglycemia at night. As     secondary objectives effect on endothelial function, renal function and biomarkers of low     great inflammation will be evaluated. So far only scarce information on face to face     comparison in ealy diabetes exists.   "
229588|NCT00857883|"     This is a first-time-in-human study. The overall purpose of the study is to assess whether     the drug is safe and well tolerated after single, increasing doses. The blood levels of the     drug after different doses will be measured and the effect of the drug on pleasurable eating     behaviour will be assessed.   "
229589|NCT00857896|"     The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of     fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive     bladder.   "
229590|NCT00857909|"     This study will investigate whether retaining potassium in the body will lead to changes in     blood pressure and changes in blood and urine samples.   "
229591|NCT00857922|"     In order to expand neuroscience research and move laboratory advances to patients, there is a     need to integrate reliable clinical data with biologic information from patient tissue     specimens. The Neuroscience Research Repository (NRR) seeks to meet this need. The NRR is a     prospective database and sample bank created to collect information and samples for current     and future neuroscience research. The objective of this NRR is to develop a data and sample     repository for study of neurological conditions. A repository utilizing standardized     electronic health data and samples collected in a uniform manner serves to foster the ability     to perform research on current and future projects. Samples and data for clinical, genomic     and proteomic analysis will be provided to optimize their value for neuroscience research.      The NRR will enroll patients and collect clinically recorded longitudinal data for as long as     they are followed by the Neurosurgery service and up to an additional 5 years after being     released from care. Patients will be enrolled on admission to the service and samples will be     taken at three time points: Time One, within 24 hours of event (preferably first blood draw);     Time Two, within 48 hours of event; and Time Three, time of any residual tissue availability.     Family members of select groups of patients will also be approached for enrollment.      Samples and data will be labeled with a study code to maintain confidentiality. Samples and     data will be maintained in secure, limited access environments with back-up/redundancy     procedures in place. Sample inventory will be maintained with a bar-coding system. A duty to     warn clause will be included in the consent as will the determination of willingness to be     re-contacted for future research. Time of sample acquisition to time of sample processing     will be documented for quality control purposes. Freezers will be monitored for temperature     stability. Recipient investigators will be requested to provide feedback on sample quality.     Samples will be distributed to neuroscience investigators after approval from the     Neurosurgery Scientific Review Committee - Dissemination Review Committee and the Committee     for the Protection of Human Subjects (CPHS).   "
229592|NCT00857935|"     A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse     in subjects with Pediculosis Capitis   "
229593|NCT00857948|"     This is a Phase 2 single center study designed to compare the safety, local tolerability, and     efficacy of 3 strengths of ivermectin treatment conditioner to placebo.   "
229595|NCT00857974|"     The physical function of older candidates for renal transplantation and their ability to     sustain physical activity programs are currently unknown. The primary goal of this study is     to determine the feasibility of a physical activity intervention in older dialysis-dependent     patients, assessing its effect on maintaining transplant candidacy and outcome after     transplantation. Clinical practice guidelines do not set an absolute age limit for evaluating     potential renal transplant candidates. While cardiovascular risk assessment and malignancy     screening are emphasized in the older age group, physical performance and the risk for     disability are often overlooked. Although healthy older patients experience increased life     expectancy after renal transplantation versus remaining on dialysis, outcomes such as the     capacity to live independently and function well have not been studied. Given the poorer     baseline health status in aging end-stage renal disease patients, rapid changes in health on     dialysis, and the national organ shortage, it is increasingly important to identify factors     that predict better outcomes and devise strategies that will maximize the benefit of     transplantation in older individuals.      The investigators hypothesize that muscle is the principal organ system underlying impaired     physical function among older transplant candidates, and that decreased muscle mass and     physical functioning lead to poorer outcomes in older renal transplant candidates. The     investigators propose that a simple bedside performance measurement of lower extremity     functional limitations, the Short Physical Performance Battery, will be a strong predictor of     outcomes in this patient cohort. The investigators also propose that outcomes can be improved     with exercise training, potentially leading to longer durations of active transplant     candidacy and greater independence after successful transplantation. The Specific Aims of     this research are:        1. Determine the feasibility of an exercise intervention in dialysis-dependent wait-listed          patients age 60 years and over who will be randomized to one of two groups: usual care          versus a structured physical activity program.        2. Define the natural history of physical function in patients age 60 years and greater who          remain on dialysis or undergo renal transplantation attempting to identify a subgroup of          older wait listed patients who are at high risk for developing disability.   "
229596|NCT00857987|"     Evaluate the improvement of the common cold with the use of medication   "
229597|NCT00858000|"     Hepatocellular carcinoma is an aggressive disease with limited therapeutic options.     Therefore, new approaches to treat this type of cancer are needed with immunotherapy     potentially being one of these. As a first step in the development of novel therapies,     expression analysis of specific markers, including tumor antigens will be carried out. This     will be done retrospectively using available hepatocellular carcinoma tissue samples.   "
229598|NCT00858013|"     This multi-center, randomized controlled study aims to evaluate the durability and efficacy     of nateglinide therapy for long term glycemic control compared with glimepiride.   "
229599|NCT00858026|"     When mothers wanted to shift from breast milk to infant formulae, babies were randomly     assigned to receive a fermented or a standard formula. Biological and clinical investigations     were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of     study formula. Intestinal microbiota was assessed by using culture-dependent techniques.   "
229609|NCT00858169|"     The purpose of this study is to:        1. To investigate the wrist joint synovial blood flow intensity and model by quantitative          three-dimensional (3D) power Doppler ultrasonography (PDUS) in patients with rheumatoid          arthritis before and after initiation of a new medicine and compare these data with          routinely used clinical data and laboratory findings, such as pain score, erythrocyte          sedimentation rate (ESR) and C-reactive protein (CRP)        2. To investigate the intra-observer and inter-observer agreement of quantitative 3D PDUS          assessment of the vascularity in wrist joints and knee joints using automatic volume          scan.   "
230946|NCT00874952|"     The aim of the study, is to assess the prevalence of metabolic syndrome in Italy on a     regional basis, defined according to National Cholesterol Education Program/Adult Treatment     Panel III (NCEP/ATPIII) guidelines criteria.   "
229600|NCT00858039|"     Trastuzumab (Herceptin®) increases the chances of cure in patients with Her-2 overexpressing     early breast cancer. Unfortunately, both the chemotherapy drugs used in this setting     (anthracyclines) and trastuzumab are known to cause cardiac dysfunction in a proportion of     patients. Patients who develop heart problems when taking trastuzumab might have to stop this     treatment, which could jeopardise their chances of cure. N-terminal pro-B-type natriuretic     peptide (NT pro-BNP) is a cardiac biomarker that is measured in the blood, the levels of     which have been shown to indicate the presence of heart failure. Some early research has     suggested that there may be a correlation between elevated NT pro-BNP and heart damage due to     cancer chemotherapy and also trastuzumab. Troponin is another substance measured in the blood     that can indicate heart damage. Finally, certain variations in an individual's genetic makeup     (called polymorphisms) could put them at increased risk of heart damage from trastuzumab.     Here we are studying whether any of these factors (NT pro-BNP levels, troponin levels, or     certain genetic polymorphisms) can accurately predict who is at highest risk of     trastuzumab-related cardiotoxicity.      The principal aim of this study is to evaluate the utility of NT pro-BNP as a predictive     biomarker for the development of trastuzumab related cardiotoxicity (TRC). The investigators     will also examine if single nucleotide polymorphisms in the HER2 gene or Fc-gamma-receptor     genes predict for TRC.   "
229601|NCT00858052|"     The objective of this study is to determine the safety and effectiveness of the IDEAL IMPLANT     in women who are undergoing primary breast augmentation or replacement of existing     saline-filled or silicone gel-filled augmentation implants.   "
229602|NCT00858065|"     This study explores whether giving families a choice of family-based prevention programs to     prevent adolescent alcohol use will make a difference in program recruitment, retention,     completion, as well as adolescent outcomes. Half of the families are assigned to a     traditional random control trial condition and half are assigned to a choice condition.     Further, this effectiveness study is being implemented by Kaiser Permanente Health Care     system, and explores the issues of implementing such programs within such settings.   "
229603|NCT00858078|"     Background:        -  Mutations detected in the BRCA1 or BRCA2 genes have been show to produce very high risks          of breast and ovarian cancer (as high as 90% and 60%, respectively), as well as          accompanying risks for several other types of cancer. Women who have these genetic          anomalies and who do not have cancer are aware of their high-risk status, which can have          an effect on their ability to make decisions about personal choices and health care.        -  Researchers are interested in learning more about how people who know their cancer risk          status make decisions on personal relationships, family formation, and risk-reduction          options.      Objectives:      - To study young women s experiences and decision-making processes regarding family history,     genetic testing, couple relationships, family formation, and cancer risk management within     the context of their experiences as BRCA1/2 mutation carriers.      Eligibility:        -  Women between the ages of 18 and 35 years of age and older who have been identified as          having a BRCA1 or BRCA2 mutation. Participants must be contemplating or have experienced          couple relationships, family formation, and/or risk management and reduction.        -  Participants must be willing to have their interviews digitally recorded      Design:        -  Researchers will conduct between 30 and 50 telephone interviews of study participants.          Each interview will be approximately 90 minutes in length. The interview consists of          open-ended questions that ask about the participants and their experiences before,          during, and after they underwent genetic testing for BRCA1/2.        -  At least one focus group will be coordinated at a national conference for individuals          who are aware of their genetically based cancer risk. If more than 25 individuals are          interested in participating in the group, an additional focus group will be convened.        -  No medical treatments are specifically offered as a part of this study.   "
229604|NCT00858104|"     Thyroid nodule pathologies occur frequently and represent a clinical issue for the     endocrinologists, surgeons, nuclear physicians as well as the general practitioners. The     incidence of this pathology has been further highlighted by the introduction of the     ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is     now detected through ultrasound. The majority of nodules are benign and characterized by slow     growth, and therefore treated with suppressive doses of levothyroxine. Long-term     levothyroxine treatment has, however, several well-known side effects and limitations.      During the last years, number of controlled studies have demonstrated that ultrasound guided     percutaneous laser treatment (PLA) is able to reach the target lesion within the thyroid with     a high level of precision, and to destroy the thyroid tissue in a predictable and repeatable     fashion, without side effects.      Aim of the study:        1. to assess 1-year and 3-year effect of laser ablation therapy on the volume of benign          thyroid nodules and on nodule-related symptoms, and to compare these effects with          findings in control group without active therapy;        2. to assess the eventual re-occurence of thyroid lesions (observed after other types of          ablation treatment, like percutaneous ethanol injection) during a 3-year follow-up;        3. to demonstrate reproducibility of results within different environments and under          different operators;        4. to validate eventual presence of major or minor side effects.      To this aim we shall randomized 200 patients either for PLA (100 pts) or standard follow-up.     Patients will be recruited, treated and followed in 4 italian centers (Ospedale Regina     Apostolorum - Roma, Arcispedale S. Maria Nuova - Reggio Emilia, Ospedale S. Maria della     Misericordia - Perugia, Ospedale di Cisanello - Pisa) by physicians with experience in     PLA.The scientific coordinator of this multicentre study is dr. Claudio Maurizio Pacella.   "
229605|NCT00858117|"     RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or carry cancer-killing substances to them. Giving     alemtuzumab together with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with     rituximab and to see how well it works in treating patients with previously untreated B-cell     chronic lymphocytic leukemia.   "
229606|NCT00858130|"     The investigators plan to perform an exploratory study to investigate the effects of     electro-stimulation of the legs on the symptoms and clinical findings of post thrombotic     syndrome (PTS), as well as quality of life of patients with PTS. The investigators theorize     that electro-stimulation will provide both a mechanical benefit via muscular contraction and     increased venous outflow from the affected extremity, as well as an anesthetic effect, which     the investigators anticipate will translate into improved symptomatic outcomes, quality of     life (QOL) benefits.   "
229607|NCT00858143|"     This open-label, national, prospective, observational, non-interventional, multi-center, post     marketing surveillance study was performed in order to examine the efficacy and safety of     Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related     co-morbidities.   "
229608|NCT00858156|"     The primary objective of the study is to evaluate the effect of hepatic function on the     pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic     impairment and in subjects with normal hepatic function.   "
229610|NCT00858182|"     A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing     strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is     to evaluate the possibility to formulate PD solutions containing xylitol and L-carnitine as     osmotic agents to partially replace glucose.   "
229611|NCT00858195|"     The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.   "
229613|NCT00858221|"     The overall goal of this study is to determine whether variations in the perilipin, and     several other, genes would be a useful tool for physicians who are caring for morbidly obese     patients to guide therapy.      The main hypotheses to be tested is that sequence variations (polymorphisms) in the perilipin     gene and several other obesity-related genes are associated with resistance to weight loss     for obese individuals on energy restricted diets, potentially playing a role in the     development of obesity related complications.   "
229614|NCT00858234|"     The clinical study determines recommended clinical dose, and evaluates the safety,     tolerability, pharmacokinetics and efficacy of MK0683 in combination with bortezomib in     patients with relapsed and/or refractory multiple myeloma in Japan.   "
229615|NCT00858247|"     The prevalence of obesity has reached epidemic proportions nationally as well as     internationally. Currently, 16 % of American adolescents are obese. In adults, obesity is a     risk factor for vitamin D insufficiency and up to 80% of obese adults have been noted to     vitamin D insufficient. In adults, low vitamin D status appears to be associated with the     development of type 2 diabetes and metabolic syndrome. There is little information on the     prevalence of vitamin D insufficiency and its implications in obese adolescents.     Additionally, it is unknown whether treatment of vitamin D insufficiency in adolescents might     result in improvement in insulin resistance, lipids and cardiovascular risk markers.      We hypothesize that vitamin D insufficiency correlates positively with insulin resistance and     cardiovascular risk in obese adolescents and that vitamin D3 supplementation improves insulin     resistance and cardiovascular risk factors in this population. The purpose of the study is to     determine the impact of vitamin D3 supplementation on various parameters of insulin     secretion, insulin action, lipids and C-reactive protein in obese adolescents.   "
229616|NCT00858260|"     Searching for high morbi-mortality risk Klotho variants in dialysis patients   "
229617|NCT00858273|"     Glutathione is normally present at high levels in the blood and plays an important role in     the body's defense against oxidative stress, that is, against the damage caused to the body     by several reactive oxygen species produced by the metabolism of most nutrients, including     glucose. Glutathione is a small peptide made from 3 amino acids, glutamate, cysteine, and     glycine.      This study is looking at how blood sugar levels may affect the way glutathione is made and     used by the body. Since glutathione is continuously synthesized and broken down, the amount     of glutathione present in the blood depends on the balance between its rate of synthesis and     its rate of use.      In earlier studies, we found that in poorly controlled diabetic teenagers, glutathione was     low, not because it was not produced fast enough, but because it was used at an excessive     rate. In this study, we want to find out whether improving blood sugar control will increase     glutathione levels, and, if so, how long this will take. We also hope to find out if oral     supplementation with a mixture of several antioxidant vitamins and minerals will increase     glutathione levels more than taking a placebo.   "
229618|NCT00858286|"     The purpose with this study is to describe in detail the control or lack of control of     asthma, based on two different dosing strategies, regular treatment with SERETIDE in a stable     dosing with short acting beta-2 agonists as needed, or maintenance treatment with SYMBICORT     and using the same inhaler with SYMBICORT as needed.   "
229619|NCT00858299|"     This study is a multicenter, prospective, interventional study. It does not have a control     group. All participants will receive 160 mg valsartan for 8 weeks. Among them, the patients     with persistent proteinuria (defined as proteinuria more than 1 g/g after 8 weeks treatment     of valsartan) will receive 320 mg valsartan for further 16 weeks. Participants who did not     receive any ACEI or ARB previously will have a titration period for 4 weeks (80 mg for 4     weeks, 160 mg for 4 weeks, and then 320 mg for 16 weeks).      The investigators will evaluate the change of urinary angiotensinogen excretion between at     baseline, at 8 weeks, and 24 weeks.   "
229620|NCT00858312|"     Obesity is a national epidemic with multiple causes and complex solutions. Research in both     animals and humans has suggested that the inclusion of dairy foods into a moderate calorie     restricted diet can increase weight loss and fat loss. Our proposed project extends these     prior findings by determining, for the first time, how inclusion of dairy in a     calorie-restricted diet changes the amount of visceral adiposity in overweight and obese     subjects. The investigators also propose unique studies to evaluate the potential     mechanism(s) by which dairy promotes weight and fat loss during dieting, through an     examination of adipocyte size, gene expression, and inflammatory markers. The hypotheses     under investigation are (1) that inclusion of dairy foods in a modest energy restricted diet     will significantly increase body fat loss compared to a control diet; (2) that dairy products     in a modest energy restricted diet will result in greater fat loss from intra-abdominal     adipose tissue compared to the control, 3) components of dairy products up- or down-regulate     the secretion of metabolically-relevant hormones during the postprandial and inter-meal     periods, 4) dairy products will promote satiety and/or satiation, 5) dairy foods reduce     adipocyte differentiation and/or enhance adipocyte apoptosis, leading to concomitant white     adipose tissue (WAT) expression changes for genes playing a role in these processes, 6) dairy     foods will reduce adipocyte lipid storage and enhance pathways associated with thermogenesis     and mitochondrial function in WAT, as reflected in gene expression changes and reduced     adipocyte size, and 7) dairy foods included in a modest energy restricted diet will decrease     inflammation in WAT and other tissues, thus decreasing circulating cytokines, increasing zinc     status, decreasing expression of inflammatory markers in WAT, and reducing WAT macrophage     infiltration.   "
229621|NCT00858325|"     The primary objective of this study is to characterise the pharmacokinetics and dose     proportionality of daptomycin after single and multiple (once daily) 4mg/kg and 6 mg/kg doses     of daptomycin in healthy Chinese volunteers.   "
229622|NCT00858338|"     This study is to evaluate the efficacy and safety of addition of intraperitoneal (ip)     Floxuridine to adjuvant chemoradiation therapy for patients under-going potentially curative     stomach resection.   "
229623|NCT00858351|"     The purpose of this study is to examine potential treatment options for a condition in     diabetics that causes tingling, pain, and numbness in the hands and /or feet, also known as     diabetic peripheral neuropathy.   "
229624|NCT00858364|"     This is a double-blind, randomized, placebo-controlled phase 3 non-inferiority study in     subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the     treatment of stage IV Non-Small Cell Lung Cancer (NSCLC). Approximately 3000 subjects with     stage IV NSCLC expecting to receive at least 2 additional cycles (at least 6 total weeks) of     first line myelosuppressive cyclic chemotherapy will be enrolled into the study. Subjects     will be randomized in a 2:1 allocation (Group A: darbepoetin alfa 500 µg every 3 weeks <Q3W>,     Group B: placebo Q3W)   "
229927|NCT00861757|"     This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design,     multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12     weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).   "
229625|NCT00858377|"     This first-in-human study of AMG 900 will be conducted in two parts: dose escalation and dose     expansion. The dose escalation part of the study is aimed at evaluating the safety,     tolerability and PK of oral AMG 900 in subjects with advanced solid tumors. Up to 50 subjects     may be enrolled in dose escalation. The dose expansion part of the study will consist of 42     subjects in three taxane-resistant tumor types. The dose of AMG 900 will be dependent upon     data from the dose escalation part of the study   "
229626|NCT00858390|"     The investigators propose to assess 36 donors' nutritional status using accepted parameters     (prealbumin, resting energy expenditure); to assess nutrient intestinal absorption through     13Curacil breath tests; and to evaluate serum concentrations of IL-6 and TNFalpha to     determine if continuing or initiating enteral feeding and nutritional supplementation is     effective in restoring or maintaining nutritional parameters.   "
229627|NCT00858403|"     The main purpose of this study is to learn how patients with Advanced Non-Small Cell Lung     Cancer (NSCLC) respond to the study drug Dasatinib. The study drug, Dasatinib, has been     approved by the U.S. Food and Drug Administration (FDA) for treatment of leukemia, but has     not been approved for the treatment of other kinds of cancer. The use of Dasatinib in this     study is considered experimental.   "
229628|NCT00858416|"     The study evaluated the efficacy of combined mechanical vibrations, continuous passive motion     and heat on the severity of pain in management of osteoarthritis of the knee   "
229629|NCT00858429|"     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill     tumor cells. Specialized radiation therapy, such as yttrium Y 90 glass microspheres that     deliver a high dose of radiation directly to the tumor, may kill more tumor cells and cause     less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Capecitabine may also make tumor cells more sensitive to radiation     therapy.      PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 glass     microspheres when given together with capecitabine in treating patients with liver     cholangiocarcinoma or liver metastases.   "
229630|NCT00858442|"     Does the addition of Platelet-Rich Plasma (PRP) to release of burn contractures and skin     graft on the limbs of children with retractable burn sequelae reduce the initial time of the     compressive treatment and maintain or lower the graft's retraction?   "
229631|NCT00858455|"     The purpose is to study the effect of Maalox® and One A Day® on the pharmacokinetics of     GSK1349572, and also to compare the safety of GSK1349572 when administered alone and when     administered with Maalox® and One A Day®. There are four dosing periods in this study, each     period requires a 4 night stay. A follow-up visit is also required at approximately 7 days     after the last dose administration. Starting from the first period to the follow-up, it will     take about 1 month. Screening visit is required to be completed within 30 days prior to the     first dose.      MAALOX® is a registered trademark of Novartic Consumer Health, LLC. ONE A DAY® is a     registered trademark of Bayer Healthcare LLC.   "
230036|NCT00865605|"     The purpose of this study is to compare the vasoconstriction response profile and     bioequivalence between one innovator lot of Ultravate® 0.05% ointment and one test/generic     lot of Halobetasol propionate 0.05% ointment (Alpharma USPD, Inc.).   "
229632|NCT00858468|"     Primary Objective:      To describe the safety of the 2004-2005 pediatric formulation of the inactivated,     split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the     package insert for vaccine-naïve young children) to the investigational and control groups.      Observational Objective:      To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers     (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the     investigational and control groups.   "
229633|NCT00858481|"     A pilot dose ranging study to evaluate the safety and efficacy of different strengths of     Spinosad Creme versus a vehicle control.   "
229634|NCT00858494|"     The purpose of this study is to determine if a commercially available homeopathic cold remedy     for children is effective in providing relief from cold symptoms in children 2-5 years old.     It is postulated that children will have relief of symptoms after receiving a dose of the     cold remedy   "
229635|NCT00858507|"     The objectives of this study are to test an evidence-based model for improving primary and     preventive care engagement among homeless Veterans not currently receiving care and to     demonstrate the additive benefit of primary care-based treatment engagement by this     population.   "
229636|NCT00858520|"     A biobank of Serum, plasma, DNA samples together with clinical information including specific     questionnaires, complete pulmonary function and chest CT-scan, is prospectively collected in     patients seen at the investigators' clinical service.      The objective is to study candidate gene pathways in COPD and or lung cancer and to associate     them with the clinical characteristics and phenotypes of COPD/emphysema and lung cancer.      In subgroups of well characterised patients, other biological materials are also collected     (lung tissue biopsies, peripheral blood mononuclear cells).   "
229637|NCT00858533|"     This pilot study will compare workplace health intervention delivered by advisors based in GP     practices with normal GP care to assess the usefulness of the concept and its potential for     wider use in a larger randomised controlled trial.   "
229638|NCT00858546|"     The aim of the study is to test the effects of low frequency deep rTMS using the novel H-coil     on the motor, affective and cognitive deficits in patients with Parkinson's disease (PD) and     to establish its safety in this population.      The investigators anticipate to recruit 10 patients to an open pilot study. All patients will     receive an active rTMS stimulation and will be given 12 treatment sessions, over a period of     up to 4 weeks. Each of the 12 daily treatment sessions (lasting about 30 minutes each), will     be consisted of 25 stimulation trains over the prefrontal cortex (20Hz trains, 2 seconds each     with an inter-train interval of 20 seconds) and one train of 15 minutes at 1 Hz over the the     motor cortex.      The following outcome measures will be taken prior to the treatment (screening visit), and at     day 1, 10, 30, 60, and 90:        1. Unified Parkinson's Disease Rating Scale (UPDRS )        2. Clinical Global Impression of Severity (CGIS)        3. Pegboard test.        4. Tapping test        5. Up & Go test        6. Abnormal Involuntary Movement Scale (AIMS) Mood and affect Beck Depression Inventory          (BDI) Cognition      1. Mini mental State examination (MMSE) 2. Digit forward and backward tests. 3. Word fluency.     4. Frontal Assessment Battery (FAB)      Side effects will be closely monitored by the researchers and will be promptly reported to     the IRB   "
229639|NCT00858559|"     Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device     follow-ups every 3 months, to verify proper ICD function. However, many follow-ups are     uneventful, revealing no relevant changes related to the implanted device and in the     patient's diagnostic and therapeutic status. For time and economic reasons, longer follow-up     intervals are frequently used although they are not according to recommendations. This may     increase the delay in detection of relevant changes in the disease and in deviations from     optimal ICD therapy in the individual patients. In the newest ICDs, the essential parameters     reflecting safety and appropriateness of ICD therapy (threshold, impedance, intracardiac     electrogram, etc.) are transmitted via Home Monitoring on a daily basis, to an internet     platform accessible by the attending physician.      In the present study, the investigators evaluate safety and efficacy of 12-month follow-up     intervals in ICDs with Home Monitoring capability, as compared with conventional 3-month     follow-up scheme.   "
229640|NCT00858572|"     The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib)     in subjects with hematologic malignancies.   "
229641|NCT00858585|"     This study will examine genes in three different tissues and look for similarities and     differences between normal cells and cancer cells. The tissues to be studies come from blood,     lymph node and cancer.   "
229642|NCT00858598|"     This study was designed to observe the outcomes of Pro Osteon according to its cleared     indications for use.   "
229643|NCT00858611|"     Objectives:        -  To evaluate the safety and tolerability of a prime-boost study regimen that includes the          recombinant DNA vaccine followed by licensed 2008/2009 FluLaval(Registered Trademark) in          adults ages 18-50 years and adults ages 51-70 years as compared with control groups that          receive the licensed vaccine only.        -  To evaluate whether the study participants in each age group receiving a prime-boost          schedule have a greater frequency of H1 or H3 neutralizing antibodies compared with          those of the same age group who received only the 2008/2009 trivalent influenza vaccine.        -  To evaluate differences in antibody or T cell responses (quantity, quality, or          durability) between the two groups.      Eligibility:        -  Participants ages 18 to 70 years of age who are available for clinic follow-up through          Week 24 and who have no previously undiagnosed clinically significant chronic diseases.          Participants will provide blood samples for further testing to determine eligibility.          Females must not be or become pregnant during the study.        -  Volunteers who have been immunized with the current season FDA-approved influenza          vaccine (2008-2009), or who are being treated for tuberculosis may not participate.      Design:        -  The study lasts for 24 weeks.        -  Week 0: The first day of Week 0 (i.e., Day 0) is defined as the day of enrollment and          first injection. Specific eligibility is reviewed. Participants will receive an          injection of either the DNA vaccine VRC-FLUDNA047-00-VP (at 4 mg dosage) or a placebo.        -  Week 4: All study participants will receive an injection of the trivalent seasonal          influenza vaccine, according to the manufacturer's package insert directions.        -  Participants will be given 7-day diary cards on which to record temperature and symptoms          (e.g., muscle aches, headache, chills, nausea) and injection site reactions (e.g., pain,          tenderness). Participants may also enter this information via the Internet. Presence of          symptoms may require additional visits to the clinic.        -  Participants will return to the clinic 2 weeks after each injection for the following          procedures:        -  Blood draws for further tests to determine the immune system's response to the          vaccine(s) Clinical evaluations: vital signs and weight, examinations of the lymph          nodes, and targeted physical exam on any visit if indicated by interim complaints or          laboratory findings.   "
229697|NCT00852969|"     The purpose of this study is to obtain information on whether raising levels of     HDL-cholesterol (the good cholesterol) can improve how blood vessels work in kidney     disease. This may help us understand the causes leading to high rates of heart disease in     kidney disease and also ways to reduce this risk.   "
229644|NCT00858624|"     A cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult     non-smoking population. Chronic cough has many associated complications including     incontinence, muscular chest pains, blackouts and depression. Current treatment is often     ineffective in these patients. To develop new medications the investigators need to     understand more about the mechanisms that can lead to excessive coughing.      This study plans to compare a group of 12 healthy volunteers and 12 patients with a chronic     cough. The investigators hypothesise that that chronic cough patients have a more sensitive     cough reflex as a result central nervous system hyper-excitability (central sensitisation).     The investigators will measure cough reflex sensitivity before and after administration of     ketamine, a medication that blocks an important receptor in the central nervous system.   "
229645|NCT00858637|"     The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo     and non-inferiority with simvastatin in reducing serum low-density lipoprotein     (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study     incorporates a Washout Period and two treatment periods - an active comparison phase and a     placebo-controlled withdrawal phase.   "
229646|NCT00858650|"     The primary objective of the Registry of HYpogonadism in MEn (RHYME) is to establish and     maintain a large, multi-national prospective registry of male patients who have been     diagnosed with male hypogonadism (HG), also known as androgen deficiency or testosterone     deficiency.   "
229647|NCT00858663|"     The purpose of this study is to determine the best doses of RAD001 (everolimus) tablets and     cisplatin to give to patients who are receiving radiation therapy for head and neck cancer.   "
229648|NCT00858676|"     The objective of this trial is to investigate the effect of early treatment of glucose     toxicity with acarbose, a drug to control postprandial hyperglycemia, on the occurence of     cardiovascular events and the inhibition of atherosclerosis.   "
229649|NCT00852345|"     Clofazimine has shown effectiveness in the treatment of leprosy for many years. The World     Health Organization and the National Hansen's Disease Program consider clofazamine to be     standard therapy for treatment of multibacillary leprosy. In recent years, the availability     of the drug has become limited and is currently available only under a research protocol and     is considered investigational. Use of Clofazamine in patients presenting with lepromatous     leprosy is necessary for patients exhibiting nerve involvement or lesions resistant to other     therapies. This drug will be used prospectively for patients who require treatment of leprosy     as deemed appropriate by a Kaiser Permanente Southern California physician.   "
229650|NCT00852358|"     This is a 24-month study of the use of laronidase administered into the spinal fluid to treat     cognitive decline in mucopolysaccharidosis I (MPS I). MPS I is a rare genetic condition due     to deficiency of the enzyme alpha-l-iduronidase. Laronidase is the manufactured form of the     enzyme alpha-l-iduronidase.      MPS I is a heterogeneous disease with several clinical phenotypes ranging from the most     severe, Hurler syndrome, to the attenuated forms, Hurler-Scheie and Scheie. Although patients     with milder forms of MPS I may not have grossly observable problems with cognition, these     patients do have learning difficulties that are apparent in school and with     neuropsychological testing. The goal of this study is to evaluate whether intrathecal     recombinant human alpha-l-iduronidase (rhIDU) injections can stabilize or improve cognitive     decline in individuals with MPS I.   "
229928|NCT00861770|"     This will be a clinical test to determine if using blood volume measurements (BVM) to help     guide fluid removal with ultrafiltration in patients hospitalized with decompensated heart     failure leads to improved outcomes.   "
229651|NCT00852371|"     This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy,     safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary     objective of the study is to compare the efficacy of different combination antimalarial     regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP),     dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment     (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after     42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic     infections and the efficacy for prevention of new infections.   "
229652|NCT00852384|"     The purpose of this study is to compare the effects of noninvasive pressure support     ventilation and early alveolar recruitment maneuver during anesthesia induction of morbidly     obese patients on both oxygenation and functional residual capacity modifications.   "
229653|NCT00852397|"     The purpose of this study is to assess the bleeding safety (the composite endpoint of major     and clinically relevant non-major bleeding) of 2 doses of apixaban (2.5 mg BID and 5.0 mg     BID) or placebo in combination with standard therapy (aspirin and /or additional antiplatelet     therapy) over a 24 week treatment period in selected subjects with recent (≤7 days) acute     coronary syndrome.   "
229654|NCT00852410|"     Obtaining adequate hemostasis is crucial during endoscopic sinus surgery. Submucosal     injection of local anaesthetic containing adrenaline has frequently been used to improve     surgical milieu. However, injection of adrenaline has potential side effects including     tachycardia, hypertension as well as inducing arrhythmia. The aim of this randomized clinical     trial is to assess the hemodynamic and hemostatic effects of two different concentrations of     adrenaline in local anaesthetic used during endoscopic sinus surgery.   "
229655|NCT00852423|"     Malaria is the most important human parasitic disease and is responsible of high morbidity     and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are     almost always excluded from clinical trials; thus, the investigators lack sufficient     information on the safety and efficacy of most antimalarials in pregnancy. The recommendation     of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and     3rd trimester is already implemented in several African countries, however documentation of     their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to     evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate,     mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women     with P. falciparum malaria; the results will help to recommend the optimal therapy for this     high-risk group in Africa.   "
229656|NCT00852436|"     The purpose of this study is to determine whether pregabalin can decrease pain and improve     quality of life in patients who have nerve pain on the mouth or the face   "
229657|NCT00852449|"     Postoperative organ dysfunction severely affects the prognosis of surgical patients. Despite     several trials evaluating restrictive or liberal fluid strategies, the ideal fluid     replacement strategy remains controversial. Owing to the risk of altered tissue perfusion, a     key trigger of organ dysfunction, the purpose of this study was to compare the influence of     restrictive and liberal fluid regimens, using a goal-directed approach, on hypovolemia and     postoperative organ dysfunction.   "
229658|NCT00852462|"     The purpose of this study is to develop and test the usability of a computerized symptom     assessment and management intervention system in a laboratory setting (phase I) and its     feasibility in a clinical setting in a group randomized trial (phase II).   "
229659|NCT00852475|"     The purpose of the study is to examine the effects of 2 commonly used diets, a Mediterranean     monounsaturated fatty acid enriched (MUFA) or AHA polyunsaturated (PUFA) enriched diet     combined with the VA Managing Overweight/Obesity for Veterans Everywhere (MOVE!) program so     as to determine which one is superior in reducing cardiometabolic risk factors associated     with Metabolic Syndrome. The risk factors considered include lipids and lipoproteins,     inflammatory markers such as CRP and adiponectin, endothelium-dependent flow-mediated     vasodilatation (FMD) and the postprandial lipid responses to a meal.      Cardiometabolic risk factors will be determined by measuring several cardiovascular risk     associated parameters including:      Biochemical measurements of lipids and inflammatory markers, body composition and VO2max     (Specific Objective 1, Descriptive).      Postprandial response to a meal challenge and endothelial vasoreactivity (FMD) assessed by     BART (Specific Objective 2, Physiological).      Determination of the effects on postheparin lipases and transfer protein activity, visceral     adipose tissue (VAT) and homeostasis model assessment-estimated insulin resistance (HOMA-IR)     (Specific Objective 3, Mechanistic)   "
229660|NCT00852488|"     This study is designed to evaluate medium-term central venous catheter placement in infants     undergoing complex cardiac surgery using a new technique. This technique involves placement     of the catheter into the inferior vena cava through a subcutaneous tunnel and through a     tunnel between pericardium and diaphragm.   "
229661|NCT00852501|"     Characterization of receptors present in non-functioning pituitary macroadenomas by Reverse     Transcriptase- Polymerase Chain Reaction (RT-PCR) would assist with targeted medical therapy     based on the information obtained by immunohistochemistry and RT-PCR.   "
229662|NCT00852514|"     Peritoneal dialysis (PD) is a widely used modality of renal replacement therapy. Due to its     continuous nature of therapy, better control of fluid status and preservation of residual     renal function were presumed by most nephrologists. However, recent evidences showed that it     might not be the case. The severity of fluid overloading and the need for anti-hypertensive     agents to control blood pressure seems to be more severe for PD patients. Therefore, more     aggressive strategy to control dry weight is mandatory in PD patients. However, over     reduction of dry weight might affect residual renal function (RRF) and, probably, the     survival of PD patients. A balance between reduction of dry weight and preservation of RRF is     crucial for the care of PD patients. Currently, only clinical measures like cardiothoracic     ratio on chest X-ray and absence of pedal edema were used to evaluate PD patient's dry     weight. There is no objective method to determine dry weight accurately. In this prospective     and randomized study, the investigators will use multi-frequency bio-impedance (MF-BIA) to     detect intracellular and extracellular water (ECW) content of patients.   "
229982|NCT00864903|"     A new enzymatic assay was developed by NMD Diagnostics for rapid diagnosis of Enteroviral CNS     infection. This study will compare this assay to RT-PCR, by testing human CSF samples taken     from children at the ER who are undergoing a spinal tap due to suspicion of meningitis.   "
229663|NCT00852527|"     The purpose of the proposed study is to determine the clinical validity and reliability of     the VA's Traumatic Brain Injury (TBI) Clinical Reminder Screen and the Comprehensive TBI     Evaluation used to screen for mild traumatic brain injury. Examining the reliability of the     two screens will determine whether they are dependable. Verifying the clinical validity is     important because valid screening and evaluation of mild TBI leads to accurate diagnosis and     timely treatment. Accurate screening also improves clinical efficiency and ensures that     resources are provided to those who need them most. The project findings are expected to     advance the science of screening and diagnosis of a mild TBI event.   "
229664|NCT00852540|"     The purpose of this study is to provide further evidence of the clinical and bacteriological     efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA.     Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days     or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up     (7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The     primary population is the per-protocol MRSA population. It is anticipated that approximately     500 subjects may be enrolled in order to obtain approximately 105 subjects who have a     baseline MRSA infection.   "
229665|NCT00852553|"     A collaborative research project with Dr. Kathleen Keef (Department of Physiology, University     of Nevada School of Medicine, Reno, Nevada) studying the role of putative neurotransmitters     in human intestine.   "
229666|NCT00852566|"     A randomized multi-center study comparing the effect of dasatinib and imatinib on malignant     stem cells in newly diagnosed chronic phase chronic myeloid leukemia (CML) patients. The     research hypothesis is that treatment with dasatinib 100 mg daily (QD) results in greater and     more rapid depletion of the Philadelphia (Ph) -positive stem cell pool within 6 months of     therapy than imatinib 400 mg QD in newly diagnosed CML patients. The study duration is 18     months and approximately 40 patients will be recruited to the study.   "
229677|NCT00852709|"     This is a Phase I study designed to determine the MTD and assess the toxicity associated with     clofarabine followed by fractionated cyclophosphamide in patients > 1 year of age or < 21     years of age with relapsed or refractory acute leukemias. There will be 25 to 35 patients     enrolled. Cohorts of 3 to 6 patients each will receive escalated doses of clofarabine     followed by fractionated cyclophosphamide until the MTD is reached. There will be no     intra-patient dose escalation. Single-agent cyclophosphamide will be administered by 2-hour     IVI on Day 0 of cycle 1. On Days 1, 2, and 3 and Days 8, 9, and 10 clofarabine will be     administered by IVI 2 hours before each dose of cyclophosphamide (see the treatment schema     below). A cycle is defined as 28 days.   "
229667|NCT00852579|"     Asthma is a common disease in Westernised societies, affecting up to 10% of the population.     Corticosteroids are the most effective treatment for asthma but the therapeutic response     varies considerably between individuals. A major cause of corticosteroid insensitivity in     asthma is cigarette smoking. Active cigarette smoking occurs in over 25% of adults with     asthma and a further 25% are ex-smokers. In a series of proof of concept clinical studies the     investigators demonstrated for the first time that the efficacy of inhaled and oral     corticosteroids is markedly impaired in smokers with asthma and to a lesser extent in     ex-smokers with asthma. Active cigarette smoking has other detrimental effects on asthma     morbidity including more severe symptoms, increased rates of hospitalisation, and accelerated     decline in lung function. Smoking cessation advice is often ineffective because many adult     smokers with asthma do not believe that they are personally at risk from their smoking, take     many years until stopping smoking and frequently restart smoking after quitting. Alternative     or additional drugs to corticosteroids are needed for smokers with asthma who are unable to     obtain the clinical benefits associated with stopping smoking. In a proof of concept clinical     trial the investigators will test the hypothesis that macrolides improve asthma control and     reduce sputum neutrophil counts of smokers with chronic asthma.   "
229668|NCT00852592|"     The purpose of this study is to understand the efficacy of light therapy for bipolar     depression.   "
229669|NCT00852605|"     Acute lung injury (ALI) is an early complication after allogeneic transplantation causing     significant mortality and morbidity. Little is known on early markers and treatment of this     complication. Recent data (Hilbert et al.) suggested a beneficial effect of     Non-Invasive-Ventilation in ALI-patients immunosuppressed because a many different reasons     including stem-cell transplantation.      The investigators study is designed to evaluate early markers of ALI after allogeneic     transplantation. In case ALI is documented patients are randomized to either conventional     therapy (oxygen-support) or conventional therapy plus intermittent Non-Invasive Ventilation.     The hypothesis is that Non-Invasive Ventilation improves outcome of ALI after allogeneic     transplantation.   "
229670|NCT00852618|"     The HIV integrase inhibitor, raltegravir (RAL), which was recently approved by the FDA, has     been shown in several trials to be highly effective. The main study will estimate the viral     load decay rate in treatment-naive HIV-infected participants receiving RAL and     emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).      This substudy of A5248 will similarly examine the characteristics of decrease in viral load     but will focus on estimating the time at which first-phase viral decay starts, following     initiation of the study drugs.   "
229671|NCT00852631|"     The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia     patients with acute worsening symptoms. Consequently, to assess whether the study drug is     safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42     days.   "
229672|NCT00852644|"     RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less     damage to normal tissue.      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic     radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.   "
229673|NCT00852657|"     The purpose of this study is to compare treatment benefits from surgical treatment by tendon     repair and from physiotherapy for small and medium-sized rotator cuff tears.   "
229674|NCT00852670|"     This study will assess the efficacy, safety, and tolerability of ACT-128800 in subjects with     moderate to severe plaque psoriasis.   "
229694|NCT00852930|"     Manual Lymphatic Drainage (massage therapy) with compression (wearing a tight sleeve on the     arm) is the current standard of treatment for breast cancer related lymphedema (arm     swelling). Low-Level Laser Therapy (LLLT) was approved in 2006 by the FDA for professional     and self/home treatment of lymphedema. LLLT is being offered as a treatment option in many     lymphedema treatment settings, but there are few studies of the effectiveness of LLLT as a     stand-alone lymphedema treatment or as a possible complementary lymphedema treatment modality     to Manual Lymphatic Drainage. The objective of this proposed pilot study is to examine the     impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and     complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer     survivors with lymphedema. Findings from this pilot study will be used to determine if LLLT     has possible value in the treatment of lymphedema and warrants subsequent evaluation in a     larger study.   "
229675|NCT00852683|"     Breast cancer is a devastating disease. Some women with breast cancer undergo surgery to     remove the breast and lymph nodes in the axilla (armpit). Unfortunately, surgery of this type     is associated with pain both in the days immediately following the operation and in the long     term. Pain that continues for more than three months after surgery is known as chronic pain     and affects as many as 1/5 to more than ½ of patients having this surgery. Often this pain is     of a particular type known as neuropathic pain. There have been studies demonstrating that     the intensity of pain after surgery may be related to the likelihood of developing chronic     pain. It is important to develop methods to reduce acute pain after breast cancer surgery and     to reduce chronic pain for breast cancer survivors.      Pregabalin is a medication used in the treatment of chronic pain. It has been shown to be     effective for neuropathic pain. There has also been one study demonstrating its effectiveness     in reducing pain after dental extraction. We are interested in determining whether pregabalin     taken for 14 days starting the day of surgery will reduce acute (short term) pain and chronic     pain from this type of breast cancer surgery.      In order to test ability of pregabalin for the reduction of chronic pain it may be necessary     to follow a large number of patients for up to one year after surgery. This may require     studying patients in more than one institution. Prior to starting such a large study we are     proposing a pilot or preliminary study. This study will follow a smaller group of     participants (68) for 6 months. From the pilot study we will determine the effect of     pregabalin on acute pain and logistic and statistical information required for the full     study. We will randomly assign participants to receive pregabalin or placebo (sugar pills)     for twice daily for 14 days starting one hour before surgery. We will monitor the     participants' pain at one hour after surgery, 24 hours after surgery, one week, two weeks,     three months and six months after surgery. We will also monitor for a number of other     parameters such as medication side effects and the need for other pain medications.     Recruitment of study participants is expected to take 6-7 months.   "
229676|NCT00852696|"     The purpose of this study is to determine whether treatment with anti-muscarinic medications     following sub-urethral sling procedures improves overall subjective and objective outcomes in     women with mixed incontinence with primary stress symptoms.   "
229678|NCT00852722|"     The purpose of this study is to evaluate if following a specific low fat diet will improve     the brain damage as seen by Magnetic Resonance Imaging (MRI) and to decrease the progression     of multiple sclerosis (MS) as evidenced by clinical evaluation and symptoms.   "
229698|NCT00852982|"     A sedentary lifestyle is known to be a risk factor to developing type 2 diabetes. The aim of     this study was to determine the effects of adding regular Nordic walking to daily physical     activity. Effects on quality of life, cardiovascular risk factors and functions in muscle     cells will be determined.   "
229679|NCT00852735|"     The purpose of this study is to assess the effect of optimized oil (enriched with     micronutriments) on the prevention on cardiovascular diseases.      Randomised crossover dietary intervention study:      The main objective of the clinical study is to investigate the effect of the consumption of     an optimized rapeseed oil on the lipid metabolism of volunteers as compared with the     consumption of a reference oil.      Post prandial study:      The second objective of the clinical study is to investigate the effect of the consumption of     an optimized rapeseed oil on the biomarkers of oxidative stress during post prandial period     as compared with the consumption of a reference oil.   "
229680|NCT00852748|"     Clinical and neuroradiologic study concerning patients suffering of cough, exertional and     sexual headaches disorders (pathophysiology) concerning a venous hypothesis implication,     redescribe clinical headaches specifications, confirmed if cough headaches is a clinical     entity and if it has neuroradiologic differences with effort or sexual activity headaches.   "
229681|NCT00852761|"     The purpose of the study is to determine the efficacy and safety of two different forms of a     topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.   "
229682|NCT00852774|"     The purpose of this study is to assess changes of intra-ocular pressure (IOP) and examine     preoperative facts affecting IOP in endometrial cancer patients undergoing robotic     hysterectomy compared to laparotomy.   "
229683|NCT00852787|"     The purpose of this study is to examine the effects of the digibind drug on hemodialysis     patients with high blood pressure. Digibind is used to treat toxicity from digoxin and     digoxin-like molecules which may contribute to high blood pressure.   "
229684|NCT00852800|"     Spontaneous bacterial peritonitis (SBP) is a common and severe complication of cirrhosis. The     most serious complication of SBP is the hepatorenal syndrome (HRS), which occurs in up to 30     percent of patients, with high mortality. Intravenous albumin (1.5 g/kg at diagnosis and 1     g/kg 48 hours later - standard regimen) helps to prevent HRS and improves survival. No     information exists on the efficacy of lower doses of albumin. This study was designed to     allow direct comparison among different doses of intravenous albumin in patients with SBP -     standard (SR) vs dose reduced regimen (DRR) - in order to prevent renal failure and     mortality.   "
229685|NCT00852813|"     The purpose of the study is to evaluate the tolerance of a higher dose of     arabinoxylan-oligosaccharides (AXOS) and their prebiotic activity in healthy subjects.   "
229686|NCT00852826|"     This study was intended to assess the value of a hemostatic and sealing agent, a collagen     sponge coated with human coagulation factors (fibrinogen and thrombin) (TachoSil®), for     decreasing occurrence of seroma after axillary lymphadenectomy.   "
229687|NCT00852839|"     This clinical study is to determine whether daily administration of a formulation of 552-02     improves the dry mouth condition in subjects with primary Sjögren's syndrome.   "
229688|NCT00852852|"     This research study will test a new online computer program for patients, the Electronic     Self-Report Assessment-Cancer (ESRA-C 2). The program allows patients to report symptoms and     quality of life issues and learn information about how to deal with these experiences. The     computer program is being tested to see if it can improve communications between patients and     their care team and if it can improve patients' experiences during and after treatment.   "
229689|NCT00852865|"     We want to analyse a possible effect of o dialy consumption of Lactobacillus farciminis on a     hyperalgesia on response to thermal stimulation. A comparaison of results before and after     three weeks of treatment will be made.   "
229690|NCT00852878|"     The purpose of this study is to determine if two treatments, a biofeedback and behavioral     protocol, for recurrent abdominal pain are equally effective.   "
229691|NCT00852891|"     The objective of this study was to analyze changes in cardiac function using Doppler     echocardiogram in critical patients during weaning from mechanical ventilation using two     different weaning methods (pressure support and T-tube) and to compare a subgroup of     patients: success vs. failure in weaning and patients with vs. without heart disease.   "
229692|NCT00852904|"     Patterns of illness among children in the United States and other industrially developed     nations have changed substantially during the past 100 years. Before and during the first     half of the previous century, infectious diseases were the primary threat to children s     health. In contrast, the major illnesses and disorders that impair health, growth, and     development today are chronic conditions stemming from the complex interaction of     environmental exposures and inherent genetic factors. The Children s Health Act of 2000     directed the National Institute of Child Health and Development to conduct a national     longitudinal study of environmental influences on children s health in the United States. The     act specified that the study extend from the prenatal period to adulthood and investigate the     short-term and long-term influences of physical, chemical, biological, and psychosocial     environmental exposures on children s health and development, including behavioral,     emotional, and educational outcomes in addition to physical health. The National Children s     Study (NCS) is an observational longitudinal study that will enroll and follow a nationally     representative sample of approximately 100,000 U.S.-born children from before birth through     their 21st birthday. The study will screen all households within selected areas of 105     locations (primarily counties).      The major types of analysis of NCS data will include longitudinal exposure-outcome analysis,     identification of causal pathways, analysis of neighborhood effects, evaluation of temporal     effects within longitudinal data analysis of data from case-control data, and analysis of     genomic data.      Women in their first trimester of pregnancy will be invited to participate in the     pre-pregnancy portion of the NCS. Women who are not pregnant but have a high probability of     becoming pregnant will be asked to participate in the early pregnancy portion of the NCS. All     other eligible women will be asked if the study can contact them periodically to assess their     pregnancy status. They also will be asked to contact the NCS should they become pregnant.     Women identified as pregnant within 4 years after initial screening will be invited to enroll     in the NCS.      The following information will be gathered:      Mother s data and information        -  Questionnaire data interviewed and self-administered (e.g., demographics; current          pregnancy history; reproductive history; medical conditions; health behaviors; doctor          visits; medicines and supplements; housing characteristics; pesticides, product use;          occupation, hobbies; depression, stress; social support; diet; time and activity)        -  Physical measures and clinical data (e.g., blood pressure, sonograms, height, weight,          body measurements)        -  Biologic specimens (e.g., blood, urine, hair, saliva)        -  Environmental samples during home visits (e.g., dust, air, water)        -  Medical record abstraction      Infant s data and information at birth        -  Cord blood and tissue samples of the placenta and umbilical cord        -  Standardized neurobehavioral exam        -  Physical measures and clinical data (e.g., length; weight; circumferences of head, arm,          abdomen, thigh)        -  Meconium samples        -  Medical diagnoses and treatment by report        -  Selected Medical record abstraction   "
229695|NCT00852943|"     Background:        -  Mast cells are responsible for most symptoms of allergic reactions. In some allergic          diseases, it is unusually easy to cause mast cells to release their contents and cause          allergic reactions. In other cases, mast cells grow abnormally and, in rare cases, can          result in tumors. Mast cells also control other parts of the immune system.        -  Understanding why mast cells behave abnormally in allergic diseases is important to          finding better ways for diagnosing and treating these potentially life-threatening          disorders.      Objectives:        -  To screen mast cells at the genetic and functional levels to characterize abnormalities,          identify mutations, detect carrier states, and/or develop therapies for such disorders.        -  To create a library of information about inherited diseases of mast cell homeostasis and          activation, including piebaldism (problems with skin and hair pigmentation), anaphylaxis          (severe allergic reaction), allergies, asthma, atopic dermatitis (eczema), allergic          rhinitis ( hay fever ), food allergies, urticaria/angioedema (hives/swelling),          immunodeficiency diseases, and autoimmune diseases.      Eligibility:        -  Patients between the ages of 1 and 80 years who have been referred by a physician and          are known to have or be suspected of having an inherited disorder of mast cells, in          particular patients (and their relatives) with piebaldism, allergies, or anaphylaxis          that is not caused by allergies.      Design:        -  Study population will consist of up to 1000 participants in a 5-year period. One third          of the study population will consist of patients; the other two thirds will consist of          biological relatives.        -  Evaluation is limited to testing on blood specimens; no treatment will be provided.        -  Clinical and research laboratory evaluations of patients will include the following:        -  Clinical evaluation and previous laboratory tests as documented in outside medical          records by health care providers. A standard questionnaire will also be administered at          the time of subject enrollment.        -  Blood collection for clinical laboratory testing, tailored to each subject s clinical          evaluation where appropriate (5 ml).        -  Blood collection for research laboratory testing, tailored to each subject s clinical          evaluation including genetic screening and assessment of mast cell growth and          functioning and storage of additional frozen blood specimens for future studies (up to          an additional 30 ml).        -  Evaluations of blood relatives will include the following:        -  Clinical evaluation as documented from outside medical records by health care providers          and administration of a standard questionnaire.        -  Blood collection where indicated for diagnostic or research purposes.        -  After 12 consecutive months on the study, results from initial evaluation will be          reviewed. Subjects with findings deemed to be of continued interest will be contacted          and invited to remain as active participants to this protocol for another year, provided          that they renew their consent to participate.   "
229696|NCT00852956|"     This will be a phase I, randomized, two-arm, double-blind, placebo-controlled, sequential     study in up to 50 healthy female subjects. The study will be comprised of three treatment     periods for a total of 4 weeks treatment duration:      Period I 1 week (Days 1-7) administration of betahistine daily (three times per day; 144     mg/day total) or matching placebo.      Period II 1 week (Days 8-14) titration of olanzapine once daily (2.5 to 10 mg) and     continuation of betahistine or matching placebo administration (daily; three times per day)     Period III 2 weeks (Days 15-28) of continued co-administration of betahistine/matching     placebo, three times per day, and olanzapine once daily (7.5 to 10 mg/day)   "
230037|NCT00865618|"     The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg     Tablets Under Fed Conditions.   "
229699|NCT00852995|"     This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This     research is being done to determine the effectiveness of two dosing frequencies and two     different concentrations of HP802-247, together with standard care, compared to placebo, plus     standard care.   "
229700|NCT00853008|"     Current therapeutic protocols for adult ALL consider MRD together with the baseline risk     factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for     treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult     patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study     ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated     therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and     MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in     HR Ph- adult ALL patients.   "
229701|NCT00853021|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Biological therapies, such as     aldesleukin, may stimulate the immune system in different ways and stop tumor cells from     growing. Giving bevacizumab together with aldesleukin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with     aldesleukin works in treating patients with metastatic clear cell carcinoma of the kidney.   "
229702|NCT00853034|"     The purpose of the study is to evaluate the effects of arabinoxylan-oligosaccharides (AXOS)     on the colonic metabolism and microbial composition, and to compare these effects with the     reference prebiotic fructo-oligosaccharide enriched inulin.   "
229703|NCT00853047|"     The purpose of this study is to evaluate the safety and tolerability of LX1606 versus a     placebo control in subjects with symptomatic carcinoid syndrome not managed by stable-dose     long-acting octreotide therapy. Following determination of the maximally tolerated or     effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.   "
229704|NCT00853060|"     During weaning from mechanical ventilation process, the energy expenditure in T tube is     greater than pressure support ventilation.   "
229705|NCT00853073|"     The purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma     surgery improves the success of needle bleb revisions.   "
229706|NCT00853086|"     This study is conducted in Europe. The purpose of this retrospective study is to collect     additional safety information of patients with haemophilia and inhibitors who are treated     with rFVIIa.   "
229707|NCT00853099|"     The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese     subjects with moderately to severely active ulcerative colitis (UC).   "
229708|NCT00853112|"     Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)   "
229709|NCT00853125|"     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor     lymphocytes into the patient may help the patient's immune system kill tumor cells. Giving     sunitinib together with irradiated donor lymphocytes may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving sunitinib together with irradiated     donor lymphocytes works in treating patients with metastatic kidney cancer.   "
233017|NCT00903890|"     This study is to inquire by mailed survey regarding the cardiac and general health of     patients previously treated for Hodgkin's and non-Hodgkin's lymphoma with radiation     therapy/anthracycline chemotherapy.   "
229712|NCT00853164|"     60 eligible subjects will be randomized into one of three study arms 1) aerobic exercise, 2)     resistance exercise, or 3) usual care. Baseline measurements will be done on all study     subjects, these measurements include: height, weight, dual energy x-ray absorptiometry (DXA)     for bone mineral density and lean body mass measurements, blood will be taken to measure     serum free testosterone, prostate-specific antigen (PSA), glucose, and insulin levels.     Fitness will also be evaluated using a graded exercise test. Questionnaires on health and     personal history will also be completed. Men randomized to the aerobic exercise treatment arm     will participate in a walking program three times a week for eight weeks. The participants     will start at 15 minutes per session and increase to a goal of 60 minutes per session. Men     randomized to the resistance training treatment arm will participate in an eight-week program     of eight strength training exercises three times per week. Men in the usual care arm will     receive written materials from the American Cancer Society about coping with cancer, which     includes information about participation in physical activity. At the end of the eight week     intervention participants in all three study arms will complete the same questionnaires and     measurements they completed at baseline.   "
229713|NCT00853177|"     The purpose of this study is to assess pain, at or after oocyte retrieval, the effectiveness     of self-controlled inhalation analgesia by nitrous oxide (N2O of 50% and 50% O2) by the     patient compared to a local anesthesia combined with a tablet of 0.5 mg of Alprazolam.   "
229714|NCT00853190|"     The objective of this open-label, randomized, two-period, crossover study was to evaluate the     oral bioavailability of the Mallinckrodt extended release test capsule formulation of     chlorpheniramine polistirex/hydrocodone polistirex compared to an equivalent oral dose of a     commercially available extended release oral suspension of chlorpheniramine     polistirex/hydrocodone polistirex (Tussionex® Pennkinetic® Extended Release Oral Suspension,     Celltech Pharmaceuticals, Inc.) in a test group of healthy subjects under fed conditions.   "
229726|NCT00858767|"     Previous studies have indicated that menaquinone-7 (MK-7) is the most effective form of     vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7, but     its taste is not appreciated by the Western society. For this reason, the active biological     compound has been manufactured as enriched oil or casein (≈80% of proteins in cow's     milk)-enriched powder. However, cow's milk allergy is the most common cause of food allergy     affecting a minimum of 2-3% of infants. The investigators will therefore compare this     protein-delivery system to an alternative delivery system (Arabic gum; 98% polysaccharides).     To compare the difference between powder and oil as MK-7 delivery vehicle, the investigators     will also test the efficacy of enriched linseed oil.   "
229715|NCT00853203|"     This is a Two-part Pilot Study: Part 1 is descriptive and Part 2 is a pilot randomized trial.      Part 1 will be a formative study in which individual interviews are conducted with 20     patients previously diagnosed with colorectal cancer. During open-ended interviews,     researchers will collect data on QOL issues colorectal cancer patients face and will elicit     feedback regarding development of and participation in a pilot expressive disclosure     intervention. Patients also will pilot test an assessment procedures including completing the     written questionnaires and wearing the Electronically Activated Recorder (EAR).      Part 2 will include a small randomized pilot test in which 44 patients (two cohorts of 22     patients) will be randomly assigned to the Expressive Disclosure Group Program or a Standard     Care Control Group.      Aims of the study include:        -  To conduct a descriptive study of colorectal cancer patients, through qualitative          interviews and standardized questionnaires, in an effort to assess their QOL, specific          health and emotional problems, issues related to social functioning, and preferences          regarding intervention format and logistics.        -  To use the information from the descriptive study to develop an Expressive Disclosure          Group Program for colorectal cancer patients.        -  To pilot test a novel technology called the Electronically Activated Recorder (EAR) for          assessing cognitive processing and social support in colorectal cancer patients and          compare these data to those obtained with traditional self-report measures.        -  To pilot test the Expressive Disclosure Group Program and conduct process evaluation          including rates of recruitment and retention, attendance, satisfaction, barriers to          participation, and feasibility of randomization.        -  To explore the effects of the Expressive Disclosure Group Program on outcome variables          of QOL and psychological functioning and mediating variables of cognitive processing,          coping skills, and social support.   "
229716|NCT00853216|"     The objective of this open-label, randomized, two-period crossover study was to compare the     oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an     equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 30 mg, Roxane     Laboratories, Inc.) in a test group of healthy subjects under fasting conditions.   "
229717|NCT00853229|"     The purpose of this study is to determine whether pregabalin is effective in the treatment of     vulvodynia.   "
229718|NCT00853242|"     The purpose of this clinical study is to compare the effects of Genz-644470 with the effects     of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in     hyperphosphatemic chronic kidney disease participants on hemodialysis.   "
229719|NCT00853255|"     Over the past decade, avian influenza (AI) has become a major health concern. The development     of safe and effective vaccines against avian strains that infect people is important. The     purpose of this study is to determine the safety of and immune response of an investigational     AI vaccine in healthy adults against the H7N3 strain of avian influenza.   "
229720|NCT00858689|"     Fragile X Syndrome (FXS) is the most common known inherited form of mental impairment,     developmental disability and autism. Minocycline is an antibiotic that has recently been used     to treat the mouse model for Fragile X, and was found to reverse the structural abnormalities     that are seen their brain cells. The purpose of this research study is to determine if     minocycline is an effective treatment for patients with fragile X syndrome (FXS).   "
229721|NCT00858702|"     The purpose of the study is to test the efficacy and safety of the combination of Calcium     Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class)     and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not     adequately controlled with olmesartan medoxomil alone   "
229722|NCT00858715|"     Clopidogrel plays a pivotal role in the antithrombotic regimen after percutaneous     intervention with stent implantation. However, response to clopidogrel shows a wide     interindividual variability and a high on-treatment residual ADP-inducible platelet     reactivity has already been associated with an increased risk for adverse events after     coronary stenting. In the present study, platelet reactivity will be determined by 6     different platelet function tests in patients on dual antiplatelet therapy after angioplasty     and stenting for peripheral, coronary and carotid artery disease. One hundred patients     showing high on-treatment residual ADP-inducible platelet reactivity in 2 or more tests will     be randomized to receive either 75mg or 150mg of daily clopidogrel in addition to aspirin for     3 months. The aim of the present study is to investigate the effects of intensified     antithrombotic therapy (150mg clopidogrel + 100mg aspirin daily) versus standard     antithrombotic therapy (75mg clopidogrel + 100mg aspirin daily) in patients with decreased     clopidogrel-mediated platelet inhibition after percutaneous intervention with stent     implantation.   "
229735|NCT00858884|"     The purpose of this study is to determine whether Libman-Sacks endocarditis (inflammation of     the heart valves) is the cause of neuropsychiatric manifestations (stroke, transient ischemic     attacks, cognitive dysfunction, seizures, acute confusional state, or psychosis) in patients     with systemic lupus erythematosus.      Hypothesis of the study: Libman-Sacks endocarditis (especially valve vegetations or small     valve growths) generate macro (large) and micro (tiny) emboli that occlude the medium and     small cerebral vessels resulting in altered perfusion, ischemic brain injury, and major NPSLE     (stroke, TIA, seizures, cognitive dysfunction, acute confusional state, or psychosis).   "
229723|NCT00858728|"     The immune system undergoes a range of changes as individuals become elderly. These may     manifest as an increasing susceptibility to infection or a tendency to develop autoimmune or     malignant disease. Multiple underlying factors contribute to this phenomenon of immunological     aging, and in this study the investigators will examine the possibility that inadequate diet     may be one such contributing factor. Fruit and vegetable intake, which can be low in the     elderly, is associated with reduced chronic disease risk. This proposal will test the     hypothesis that increased fruit and vegetable intake may positively affect clinically     relevant measures of immune function. One hundred healthy volunteers aged 65-85 years     following a low fruit and vegetable diet (<=2 portions/d) will be recruited and randomised to     continue following their normal diet, or to consume at least 5 portions of fruit and     vegetables daily for 16 weeks. Immune function and biochemical markers of nutritional status     will be assessed before and after the intervention period.   "
229724|NCT00858741|"     The aim of the investigators study was to determine whether 8 Gy in a single fraction     provides equivalent pain and narcotic relief compared to 30 Gy in 10 fractions for patients     with painful bone metastases.      The secondary objectives were to evaluate the frequency, duration of pain relief, narcotic     relief, toxicity and the effect on quality of life measures for each of the two treatment     arms.   "
229725|NCT00858754|"     This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous     (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related     pain and constipation from taking opioids. The length of participation will be up to 7 weeks.   "
229755|NCT00859482|"     Natalizumab is a humanized monoclonal antibody directed against Very Late Activation Antigene     4 (VLA-4) and has a potent effect on disease activity in multiple sclerosis (MS). A blockade     of VLA-4 with natalizumab may not only interfere with autoimmunological processes but also     with central nervous system (CNS) immune surveillance.   "
229727|NCT00858780|"     This study involves Rheumatoid Arthritis patients in regular clinical setting who are already     on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is     intended to identify parameters that can serve as guidance in clinical settings. This study     will consider the clinical and radiographic course in subjects when etanercept treatment is     tapered or discontinued, and analyze the subjects' experience of disease worsening and the     predictive values of clinical parameters, serum biomarkers and imaging on the clinical and     radiographic course in different treatment groups. The effect of re-treatment with etanercept     at treatment failure will also be studied.   "
229728|NCT00858793|"     Patient stem cells will be mobilized with induction chemotherapy (R)-ICE and G-CSF. If     sufficient cells can be mobilized, patients will be treated with high-dose chemotherapy and a     transplant of autologous CD34+ cells transduced with an antiviral vector (M87o). If     autologous CD34+ yield is insufficient, allogeneic gene-modified cells will be given, if a     compatible donor is available. To minimize risk of transplant failure, a second unmodified     CD34+ cell transplant will be given one week after the first transplant.   "
229729|NCT00858806|"     Standard therapy with Imatinib (IM) significantly prolongs the survival of Ph+CML patients     who obtain a complete cytogenetic response (CCgR). Elderly patients (i.e., at least 65 years)     have similar cytogenetic responses and survival, but they usually show a low compliance. The     aim of the study is to evaluate the percentage of elderly patients who maintain a CCgR with     intermittent imatinib therapy with respect to standard daily administration.   "
229730|NCT00858819|"     This is an observational study aiming to study the prevalence and risk factors for     osteoporosis and vertebral fractures in patients with ankylosing spondylitis attending three     Rheumatology clinics in Western Sweden.   "
229731|NCT00858832|"     Endomyometritis is an infection in the uterus. It can occur in up to 1 out of 5 women     having unplanned cesarean deliveries. Antibiotics are routinely given at the time of Cesarean     delivery, but the infection in the uterus can still occur. When endomyometritis occurs it can     prolong the woman's stay in the hospital after birth, slow down her recovery time at home,     and increase medical costs. Methergine is a medication that is routinely used to stop uterine     hemorrhage (excessive bleeding from the uterus) that sometimes happens after delivery.     Methergine works by contracting (tightening) the uterus. These contractions also help the     uterus to expel or remove parts of the placenta that increase the chance of developing a     uterine infection.      This research study is being done to learn if routine use of Methergine can lower the chances     of developing a uterine infection after cesarean delivery. Half of the women in this study     will receive Methergine for a few days during their hospitalization after cesarean delivery.     The other half of the women will not routinely receive Methergine.   "
229732|NCT00858845|"     People with heart failure often have weakness in their leg muscles. This study will determine     whether the leg weakness is due to very high adrenaline levels and whether the medication     clonidine can improve leg weakness.   "
229733|NCT00858858|"     This study has two major goals:        1. To determine the effects of bile salts on causing DNA injury and activating signaling          pathways that promote growth in cells from the esophagus of patients who have          gastroesophageal reflux disease (GERD)        2. To determine whether changes in bile composition induced by treating patients with a          bile salt called ursodeoxycholic acid (UDCA) can alter DNA injury, signaling pathway          activation and other types of damage in cells from the esophagus of patients who have          GERD.   "
229734|NCT00858871|"     The purpose of this study is to compare the overall survival of brivanib versus sorafenib in     subjects with advanced HCC who have not received prior systemic therapy.   "
229772|NCT00859703|"     Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal     women with early-stage breast cancer. This treatment induces bone loss and a higher risk of     fractures.      This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and     osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast     cancer   "
229736|NCT00858897|"     Glutathione is normally present at high (millimolar) levels in blood and plays an important     role in the body's defense against oxidative stress, that is, against the damage caused to     the body by reactive oxygen species produced by the metabolism of most nutrients, including     glucose. Glutathione is a small peptide made from 3 amino acids, glutamate, cysteine, and     glycine.      This study is looking at how blood sugar levels may affect the way glutathione is made and     used by the body. Since glutathione is continuously synthesized and broken down, the amount     of glutathione present in blood depends on the balance between its rate of synthesis and its     rate of use.      In earlier studies, the investigators found that in poorly controlled diabetic teenagers,     glutathione was low, not because its production was decreased, but because it was used at an     excessive rate. In this study, the investigators want to determine how short-term changes in     blood sugar levels affect glutathione levels. This will help improve our understanding of how     diabetes affects metabolism.   "
229737|NCT00858910|"     The purpose of the study is to examine if patients in the embedded motor imagery (MI)     training group (EG1) need less time to perform the motor task than patients in the added MI     training group (EG2).   "
229738|NCT00858923|"     Tulane University Health Sciences Center/Louisiana Community AIDS Research      Center Program, New Orleans, LA is seeking patients for an HIV study. The      purpose of the study is to test the safety and effectiveness of an      experimental ultra-violet light device designed to reduce virus in your blood.   "
229751|NCT00859417|"     The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In     front of the high rate of recurrences with this technique, the use of synthetic prosthesis     made their appearance. But the drawback of the use of prosthesis is their tolerability. The     system Perigee®, a prosthetic kit by trans-obturator way, was designed to obtain high     efficiency in the correction of the prolapse while reducing the risk of complications. The     lack of prospective and randomized studies makes difficult to assess the interest. The     investigators, therefore, have put in place a randomized prospective study seeking the     evaluation of the system Perigee® compared to the conventional surgical technique.   "
229752|NCT00859430|"     The objective of this study is to compare the rate and extent of absorption of an     investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the     commercially available reference product under fed conditions.   "
229739|NCT00858936|"     This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form     of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially     reduce the damage done to the heart during surgery.      This study has 2 parts. Part 1 will first test 36 subjects at different doses (amount) of the     study drug. There will be 6 different groups of 6 subjects each that will receive the study     drug or a placebo. A placebo is a substance that will be prepared to look like the study drug     but will contain no active ingredients. In Part 1, five subjects from each group will receive     study drug (IK-1001) and one will receive a placebo. This first part of this study is also a     dose (amount) escalation. This means that each group will be receiving a different dose of     the study drug. The first group will receive the lowest dose, the second group will receive a     slightly higher dose, and the third group a slightly higher dose until all six groups has     been tested. You can not choose which group you will be in but prior to starting each new     dose level, the data (information) from the previous dose level will have been reviewed by a     group of qualified individuals to determine if it is safe to proceed to the next highest dose     level.      Part 2 will expand the study and will treat at least 158 (and up to 632) more subjects at a     dose level that has been deemed safe from information collected from Part 1. Subjects in Part     2 of the study will have a 1 in 2 (50%) chance of receiving the study drug or placebo.     Whether the subject gets study drug or the placebo will be randomly assigned (like the toss     of a coin).      The study drug or placebo will be given as an intravenous infusion (into the vein) for six     hours while the subject is having their CABG surgery.      The subjects will be followed up for 6 months after their CABG surgery.   "
229740|NCT00858949|"     This is an observational study with the goal of determining the costs of nausea and vomiting     in ambulatory patients after surgery from the US societal perspective.   "
229741|NCT00858962|"     The main purpose of this protocol is to study the effect of an HIV medication known as     Raltegravir on Buprenorphine in people who have been receiving the same dose of Buprenorphine     for at least 3 weeks before study entry. This will be determined by giving Raltegravir along     with Buprenorphine and by measuring the amount of Raltegravir and Buprenorphine in the blood.     The investigators will also learn about the effects of Buprenorphine on Raltegravir and about     the safety of taking these two medications together.   "
229742|NCT00858975|"     The purpose of this study is to study the change of tumor size and serum cytokine in the     patients who received cryotherapy for the renal tumors.   "
229743|NCT00858988|"     The purpose of this study is to determine whether rifaximin is effective in the treatment of     tropical enteropathy in a population of African children at high risk for this disease.   "
229744|NCT00859001|"     Study phase: Phase II Investigational product, dosage, and route of administration:     Ibritumomab tiuxetan (Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab)     covalently bound to the chelating agent tiuxetan. To prepare the active therapeutic agent     [90Y]-ibritumomab tiuxetan, the antibody is chelated with the β-emitter yttrium-90 chloride     immediately before intravenous administration. Treatment with [90Y]-ibritumomab tiuxetan is     preceded by an infusion of rituximab (Rituxan, Mabthera) in order to optimize the     biodistribution of radiolabeled antibody by depleting CD20 positive B-cells. Rituximab is a     chimeric human/murine IgG1 monoclonal antibody. The Zevalin study regimen is given as an     infusion of rituximab 250 mg/m2 and (where biodistribution imaging or dosimetry is     compulsory) 185 MBq (5mCi) of [111In]-ibritumomab tiuxetan on Day 1 followed 7 to 9 days     later by a single dose of 14.8 MBq/kg (0.4 mCi/kg) of [90Y]-ibritumomab tiuxetan, maximal     dose of 1184 MBq (32 mCi), preceded by 250 mg/m2 of rituximab.      Indication: stage II-IV follicular lymphoma (FL) grade I-II after 4 cycles of FMR Study     objectives: Evaluation of efficacy and safety of [90Y]-ibritumomab tiuxetan, as well as     assessment of quality of life Patient population: Patients with after 4 cycles of treatment     with FMR Study design: Prospective, multicenter, open-label study designed to treat patients     with a sequential front-line treatment represented by 4 cycles FMR plus Zevalin Duration of     treatment: Four months for FMR and two treatment days one week apart followed by a 12-week     safety period for Zevalin Duration of study: Estimated duration of study is 18 months Primary     efficacy parameter: Overall response rate and complete response rate Secondary efficacy     parameters: Overall survival, Disease-free survival, health-related quality of life.      Safety parameters: Vital signs, adverse events (AEs), hematology, blood chemistry,and     immunoglobulin levels Number of study centers: 4 study centers in Italy T otal number of     patients, statistical rationale provided: Expected total of 55 patients. The final sample     size will be based on the number of events observed for the primary efficacy endpoint as     calculated in the sequential statistical model.      Adverse events: AEs observed, mentioned upon open questioning and/or spontaneously reported     will be documented.      Planned start and end of recruitment: Start of recruitment: 3rd quarter 2006. End of     recruitment: 1st quarter of 2007   "
229745|NCT00859014|"     The purpose of this research study is to find out if bone marrow treatment (bone marrow     aspiration and infusion of stem cells) can be safely used in adults who have recently (within     24-72 hours)suffered an acute ischemic stroke.   "
229746|NCT00859352|"     The primary objective of the study is to investigate if the exposure of midazolam is     clinically significantly changed by 14 days of exposure to AZD1981 through possible enzyme     induction of CYP3A.   "
229747|NCT00859365|"     This study aims to examine the efficacy of an Integrative approach utilizing Acupuncture as     an add-on therapy for the treatment back and neck pain in an emergency department setting      Acupuncture is well established as an effective treatment for back pain. The investigators     cumulative experience in Asaf Harofeh Medical Center has shown Acupuncture to be an Effective     therapy for simple back and neck pain in an ER setting.      This study will examine weather Acupuncture can decrease pain, increase range of motion and     decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain     without neurological findings. Acupuncture will be performed as an add on therapy on top of     analgesic therapy.   "
229773|NCT00859716|"     The purpose of this study is to determine whether ACE393 vaccination can protect against     Campylobacteriosis in a challenge model.   "
231312|NCT00880230|"     The purpose of this study is to determine the safety and effectiveness of the Scuba™ stent in     subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo     or restenotic lesions in the common and/or external iliac artery.   "
229748|NCT00859378|"     The hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures.     Traditionally, the cemented version of the semiendoprosthesis has been used for this     indication. However, the cementing carries a risk of fat embolism during the pressurization     of the cement. The fat embolism can be avoided when using the non-cemented     semiendoprosthesis. In this study we want to find out whether there are any differences in     the treatment results between the cemented and non-cemented semiendoprostheses when treating     the proximal femoral fractures.   "
229749|NCT00859391|"     This is a Phase 0, Double-blind study that will assess the effect of in vitro treatment of     gluten with ALV003 or with placebo when ingested by CD Subjects.   "
229750|NCT00859404|"     The study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable     mild to moderate persistent asthma. The study involves two weeks of run in period. This is a     placebo controlled study. One of the four treatment arms is placebo. The duration of     treatment is 12 weeks.   "
229753|NCT00859456|"     The purpose of this study is to determine the clinical response rate (complete response and     partial response) in patients with metastatic, locally advanced, or locally recurrent     vascular soft tissue sarcoma treated with sunitinib.   "
229754|NCT00859469|"     In patients with pleural or peritoneal mesothelioma, what is the response rate to combined     Oxaliplatin (ELOXATIN®) and Gemcitabine chemotherapy?   "
229756|NCT00859495|"     The primary objective of the study is to determine the feasibility (as determined by lack of     serious adverse events) and tolerability (as determined by patient's ability to complete the     study) of a multimodal lung sparing regimen of surgery, interpleural and intravenous     chemotherapy, and local P-32 irradiation for malignant pleural mesothelioma.   "
229757|NCT00859508|"     Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to     or is substantially equivalent to other dura replacements for the repair of the cranial dura     in patients undergoing surgical repair of the cranial dura.   "
229758|NCT00859521|"     THe objective of this study is to compare the rate and extent of absorption of an     investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the     commercially available reference product under fasting conditions.   "
229759|NCT00859534|"     Urticaria is one of the most common dermatological conditions with diverse clinical     presentations and causes. Solar urticaria (SU) is a rare subset of physical urticaria, where     symptoms are induced by direct exposure of the skin to sunlight. As little as 5 minutes of     sun exposure can cause flares and whealing on exposed skin sites, accompanied by severe     itching. The wavelengths of radiation causing the eruption (i.e. the action spectrum) are in     the ultraviolet or visible light range. Initially described by Merklen in 1904, SU may have a     very sudden and dramatic onset, and then rapidly disappear once the exposure ceases. A     delayed form of SU has also been reported, although this is extremely rare. Information on     the pathophysiology of SU is limited and symptoms are confined to areas of the body exposed     to direct sunlight. The condition can be very distressing and severely impair the     individual's ability to go outdoors and to tolerate indoor lighting. The standard therapy,     i.e. oral antihistamines, is only partially effective and may provide little worthwhile     relief of symptoms.      This pilot study is proposed to evaluate implants containing 16mg CUV1647 as a prophylactic     treatment for patients with SU. The effectiveness of CUV1647 will be assessed by determining     the minimum urticarial dose before and after treatment.   "
229760|NCT00859547|"     The objective of this study is to assess the safety and immunogenicity of recombinant     thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin     grafting in pediatric patients, newborn through 17 years of age.   "
229761|NCT00859560|"     The retrospective survey is to investigate the incidence of bone fracture in post-menopausal     breast cancer patients with Arimidex 1mg, who were previously registered for the clinical     experience investigation.   "
229762|NCT00859573|"     Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10     week, double bind, placebo controlled, randomized clinical trial to receive either modafinil     or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential     facility to achieve initial abstinence and be inducted onto study medication during wks 1-2.     Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly     psychotherapy while continuing to receive study medications. Urine samples will be collected     thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the     results of this study will contribute to our understanding of which types of agents may be     good candidates for further development as potential treatment agents for this disorder.   "
229774|NCT00859729|"     This study will assess the feasibility and safety of vaccination with increasing doses of     xenogenic DNA administered intradermally in combination with electroporation in patients with     relapse of prostate cancer. The DNA encodes prostate specific antigen (PSA) from Rhesus     Macaque (Macaca mulatta), a protein that is 89% homologous to human PSA. The study will also     assess the safety and functionality of the DERMA VAX™ (Cyto Pulse Sciences) DNA vaccine     delivery system.   "
229763|NCT00859586|"     Patients receiving allogeneic stem cell transplantation for hematological malignancies who     suffer a relapse of their disease post-transplant have limited treatment options and a poor     prognosis. With the exception of patients with chronic leukemias who may achieve prolonged     remissions after donor lymphocyte infusions (DLIs), treatments using either chemotherapy or a     DLI achieve less than a 10% median survival beyond 6 months. Most of these patients die of     progressive leukemia, underlying the need for new therapeutic approaches.      Human leukocyte antigen (HLA)-mismatched DLIs appear to possess a more potent     graft-versus-leukemia (GvL) effect. However, when given after an HLA-mismatched transplant     DLIs have a high risk of causing graft-versus-host disease (GvHD), which can be severe. To     reduce the risk of GvHD, infusions of mismatched lymphocytes from an alternative donor may be     used to avoid permanent engraftment and associated risk of GvHD.      In this study, we propose to use a novel strategy to treat leukemias relapsing after HLA     matched allogeneic stem cell transplantation by using haplo-identical DLIs to promote the     associated antileukemic effect while minimizing the possibility of permanent engraftment and     associated GvHD. To achieve only temporary engraftment and to promote disease control we will     give fludarabine immunosuppression prior to the DLI. We anticipate the infusion of     HLA-mismatched donor lymphocytes in this setting will produce no detectible engraftment or     only temporary engraftment, but may result in a strong GvL effect regardless of engraftment     outcome. We will select patients for this protocol who fall into the worst category for     post-transplant relapse. Specifically, we will enroll patients with acute leukemia or MDS     relapsing within 6 months of transplant, of which less than 5% survive beyond a year from     relapse.   "
229764|NCT00859599|"     The purpose of this study is to evaluate the efficacy and safety of monochromatic     phototherapy (Biolight®) on foot ulcers in diabetic patients, in comparison of placebo     phototherapy as a complementary to standard diabetic foot ulcer therapy.      The study initiated with a four week long Run In Period to eliminate spontaneous healing     ulcer to be included. Treatment with monochromatic phototherapy (Biolight® or placebo) will     be given locally, additional to standard care, three times weekly during the first four weeks     and twice weekly the following sixteen weeks or until the ulcer is completely healed,     according to a pre-determined treatment plan. The area of the ulcer will be measured once     weekly for 20 weeks or until the ulcer is completely healed.   "
229765|NCT00859612|"     There are two major goals of this project:        1. Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination          of the prevalence of low bone turnover in CKD-5 patients with bone loss.        2. Identification of the optimal combination of noninvasive tests for definition of the          turnover component of ROD.   "
229766|NCT00859625|"     Hypothesis-- Nurse observation in addition to the colonoscopist while withdrawing the     colonoscope from the cecum leads to a greater adenoma detection rate.      Methods- Patients presenting for screening colonoscopy are randomized to nurse observation or     usual practice. Risk factors for adenoma development and the adenoma detection rate in each     group will be evaluated.   "
229809|NCT00860210|"     This pilot feasibility study is assessing the safety and technical performance of the     Neurostep™ System for the restoration of independent gait in subjects with gait disorder     (i.e. foot drop) secondary to a CNS lesion (e.g. stroke).   "
229767|NCT00859638|"     People who have long-term conditions such as heart disease, diabetes, arthritis etc. face     challenges in staying active and able to participate in activities that are important to     them. There is some research that suggests that a care model that focuses on physical     functioning and helping patients to manage their own conditions will assist them to stay     active and healthy longer. In this project, the investigators are testing whether     physiotherapy and occupational therapy offered to groups of patients and information about     rehabilitation offered to other members of the health care team can help people with chronic     conditions to maintain their physical abilities.   "
229768|NCT00859651|"     This is a phase II study which will enroll 20 postmenopausal women who are at high risk for     breast cancer development. The goal is to determine whether a one-year intervention of     high-dose vitamin D at 2 different doses (20,000 IU weekly or 30,000 IU weekly) will increase     circulating blood levels of vitamin D and to obtain preliminary data on the biologic effects     of vitamin D for breast cancer prevention.   "
229769|NCT00859664|"     Children with autism are often treated with psychiatric drugs. These medications have been     shown to improve their language and social function, and are important in improving their     quality of life. In many cases it is difficult to determine the best drug dose, and a     favorable response occurs in only 30%-70% of individuals, with many children suffering     significant adverse drug reactions.      Pharmacogenetics is the study of the role of different genes on drug behavior. The cytochrome     P450 is the most important enzyme, involved in the metabolism of a vast number of drugs,     including psychiatric medications. The multiple variations in this gene can result in the     different response observed in different patients, even when treated with similar doses of     the drug.      Hypothesis(es):      Mapping the different types of cytochrome P450 gene, in children with autistic disorders will     improve the rate of success of medical treatment, and prevent adverse drug reactions.      Potential Impact:      If successful, our study can help thousands of children and their families by developing a     system of tailored medicine that is based on the specific activity of the various enzymes     present in that particular patient. Better medical treatment will facilitate better daily     interactions with the children and enhance their quality of life. Furthermore, recognizing     children that are resistant to medication will prevent unnecessary use of drugs.      It should be noted this is the first study focusing on children receiving psychiatric     medications using pharmacogenetics. Found to be effective, this method can also be applied to     other groups of medications and to other patients.   "
229770|NCT00859677|"     The purpose of this study is to investigate the role of T helper 17 cells (Th17) in the     pathogenesis of MRSA infections.   "
229771|NCT00859690|"     Sleep Apnea is a prevalent condition that has been increasingly diagnosed in the adult     population and is now considered an independent risk factor for the development of     cardiovascular disease. A better understanding of the mechanisms associated with the     development of cardiovascular disease in sleep apnea is needed.      This research will investigate the function of the adenosine deaminase (ADA) in subjects with     sleep disorders. This enzyme is responsible for metabolizing adenosine, a neuromodulator that     is released during periods of sleep apnea and that has been found to promote vascular     thrombosis. There are multiple types of ADA that are genetically determined and have     different levels of function. Those different forms of this enzyme may determine groups that     are more susceptible to the development of thrombosis. Given the known association between     sleep apnea and thrombosis, this study will determine if polymorphisms of this enzyme are     differentially found in subjects with sleep apnea as compared to other sleep disturbances.     The overall objective of this experiment is to assess the presence of ADA polymorphisms in     sleep apnea.   "
230047|NCT00865761|"     The purpose of this study is to compare the relative bioavailability of 3 mg Alprazolam     Extended Release Tablets by Alpharma with that of 3 mg XANAX XR® Tablets by Pharmacia &     Upjohn Company following a single oral dose (1 x 3 mg extended-release tablet) in healthy     adult volunteers administrated under fasting conditions.   "
229775|NCT00859742|"     The aim of this study is to determine the diagnostic values of EBUS-TBNA in the mediastinal     re-staging after induction treatment in patients with non-small cell lung cancer.      Primary objective:      1. To determine the sensitivity, specificity, positive predictive value, negative predictive     value and the accuracy of EBUS-TBNA in the detection of mediastinal metastasis in mediastinal     re-staging after induction treatment.      Secondary objectives:        1. To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal          re-staging        2. To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after          induction therapy        3. To determine procedure related complications   "
229776|NCT00859755|"     This is a Phase 1 study, involving a 1-day dosing period, designed to test the safety of     investigational study drug ARRY-403 in patients with Type 2 diabetes. Approximately 36     patients from the US will be enrolled in this study.   "
229777|NCT00859768|"     The purpose of this study is to evaluate the effectiveness and feasibility of the Screening     Inventory of Psychosocial Problems (SIPP) in consultation settings with respect to early     recognition and treatment of psychosocial distress, communication between patients and     physicians, and psychological distress and quality of life in cancer patients treated with     radiotherapy (RT).   "
229778|NCT00859781|"     The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591     in combination with ketoconazole and hydrocortisone against prostate cancer.   "
229779|NCT00859794|"     The overall goal of this project is to better understand the micro-physiology of human     epilepsy and cognition using the intracranial electroencephalogram (iEEG), electrical brain     stimulation, functional magnetic resonance imaging (fMRI), and histology.   "
229780|NCT00859807|"     The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer)     and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).   "
229810|NCT00860223|"     The purpose of this study is to evaluate the potential effect of multiple doses of neratinib     on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of a     single dose of digoxin.   "
229907|NCT00861497|"     The purpose of this study is to provide access to bifeprunox for patients, who have completed     previous studies with bifeprunox, and require continued treatment with bifeprunox, other     treatment not being adequate. A further purpose is to investigate the safety and side-effects     of bifeprunox during long-term treatment.   "
229781|NCT00859833|"     We will test the hypothesis that a single dose of Regadenoson will produce equivalent degrees     of coronary hyperemia in patients of widely different body size. This will be a prospective,     open-label, comparative trial using MRI to measure myocardial perfusion reserve (ratio of     myocardial blood flow with vasodilator to myocardial blood flow at rest) during sequential     administration of the coronary vasodilators adenosine and regadenoson. Non-invasive MRI     measurements of resting myocardial blood flow, and sequential measurements of blood flow     during adenosine infusion (weight adjusted dosing) and then blood flow during regadenoson     infusion (single, fixed dose. Blood flow measurements will be obtained sequentially and in     the same sequence in each subject during a two hour MRI exam. 32 subjects will be recruited     for this study. The first 2 will be for testing of the protocol. Inclusion criteria: 2     subjects for initial protocol evaluation, then 30 subjects with body mass index (BMI) between     18 and 40. Exclusions are pregnancy, renal dysfunction and claustrophobia.   "
229782|NCT00859846|"     The use of ultrasound is becoming widespread to guide the placement of arterial lines for     both vascular access and regional anesthesia in the field of anesthesia. Arterial line     placement can be challenging, especially in the pediatric population. Frequently multiple     attempts are required with relatively high failure rates. This can result in excessive needle     punctures and extended OR times. A few studies have looked at the use of ultrasound to     decrease OR time and increase success rates both in adult and pediatric populations. These     studies compared the traditional palpation method with either short axis or long axis views     of the vessel using ultrasound guidance. No study to date has compared short axis and long     axis views for arterial line placement in either the pediatric or adult population. Our study     compares success rates and OR times when long and short axis methods of arterial line     insertion are employed in the pediatric population.   "
229783|NCT00859859|"     The purpose of this study is to examine the short-term effects of vagus nerve stimulation     (VNS) by auricular stimulation (stimulation of the auricular branch of the vagus nerve which     innervates the ear) in rheumatoid arthritis (RA). RA is characterized by a chronic systemic     inflammation affecting the joints but also carries an increased risk for extra-articular     manifestations as well as other organ manifestations such as cardiovascular disease (CVD),     which significantly contributes to morbidity and mortality in this disorder.   "
229784|NCT00859872|"     This is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment     sessions, parallel-group study.      After screening period, eligible subjects will be entered 5 days treatment session I to     compare the efficacy between risperidone oral solution combination clonazepam oral and     haloperidol IM injection on controlling psychotic agitation, then will be followed by 6     additional weeks treatment session II for exploring the effect of medicine switching from IM     injection to oral.   "
229785|NCT00859885|"     The prevalence of patent foramen ovale (PFO) is about 25% in the general population and     approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke).     Given the large number of asymptomatic patients, no primary prevention is currently     recommended. On the contrary, secondary prevention is very important. Prospective studies     have shown that antithrombotic treatment (ATT) with aspirin or warfarin appears to negate the     risk of recurrent stroke associated with a PFO. Patients with spontaneous or large     right-to-left shunts (RLS), those with a coinciding atrial septal aneurysm (ASA) or multiple     ischemic events prior to the PFO diagnosis may still be at increased risk of stroke     recurrence despite ATT. Percutaneous device closure (PDC) is a challenging alternative to     ATT. Several studies reported 0% to 3.4% annual recurrence rates of stroke or TIA in patients     treated by PDC. To date, there is no data from randomized controlled trials (RCT) comparing     the risk of stroke recurrence after PDC with that under ATT only. The results from ongoing     RCTs are not to be awaited in the near future, mainly due to low enrolment and event rates.     Alternative data-gathering strategies such as multicenter registries are needed to overcome     the low recruitment rates. The aim of the present study is to compare the risk of recurrent     stroke and TIA in patients with PFO and otherwise unexplained stroke who undergo PDC or     receive ATT.   "
229786|NCT00859898|"     The primary purpose of this study is to compare the change from baseline in hemoglobin A1C     achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin     XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral     administration of double-blind treatment. The safety of treatment with dapagliflozin will     also be assessed in this study   "
229787|NCT00859911|"     This is a study of the effectiveness of multiple micronutrient supplements given by teachers     to their pupils on growth and educational achievements. The hypothesis is that children are     deficient in multiple micronutrients and that supplements will lead to improved weight gain,     growth in height and better educational achievements in tests of mathematics and language. It     is also hypothesised that micronutrients will help prevent the build up of arsenic consumed     in food and water as a result of geological contamination of water sources.   "
229788|NCT00859937|"     This phase II trial is studying how well dasatinib works in treating patients with recurrent     or metastatic malignant salivary gland tumors. Dasatinib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth.   "
229789|NCT00859950|"     Sleep apnea is a common sleep disorder characterized by temporary stops in breathing during     sleep and has been associated with the development of cardiovascular disease. This research     will investigate one potential mechanism leading to the development of cardiovascular     disorder, specifically, the blockage of blood vessels called vascular occlusion, in     subjects with sleep apnea. A group of healthy controls will be used for comparison. All     subjects will undergo clinical evaluation followed by an overnight sleep study and a morning     blood draw. Subjects with sleep apnea will be treated according to standard clinical     management and followed under the research protocol for one month. At the end of one month, a     repeat blood draw will be performed on the sleep apnea subjects for comparative analysis. If     a control subject is found to have any abnormality during this research study, he or she will     be referred for further clinical evaluation.   "
229790|NCT00859963|"     The purpose of this prospective clinical data collection is to document the performance and     clinical outcomes of the Regenerex™ Tibial Tray.   "
230376|NCT00871611|"     The prevalence of Anderson - Fabry disease in patients with left ventricular hypertrophy is     unclear. The investigators will examine urine - α - Galactosidase activity and     globotriaosylceramide isoforms in these patients.   "
229791|NCT00859976|"     The randomised controlled trial will be carried out on patients that require a total hip     replacement (THR) to reduce pain and restore their function. One way of fixing the hip joint     to the bone is by coating the implant to encourage the body to grow bone onto the replacement     hip. This study is aiming to find out whether the new (Bonemaster) coating allows increased     bony growth onto the cup when compared to the usual (plasma-sprayed) coating. This may reduce     the incidence of early failures due to poor bony attachment, which is a well known     complication for early failure of total hip replacements.      The study will compare two different types of coating (BoneMaster and Plasma-sprayed) on the     cup of the replacement hip. Density of the bone immediately surrounding the cup will be     observed to see if there are differences between the two groups. The density of bone will be     measured using standard x−ray assessment and in a smaller sample of 14 patients, using a     special scan called Dual Energy X−ray Absorptiometry (DEXA Scan). Functional comparisons will     be assessed through clinical scores.   "
229792|NCT00859989|"     RATIONALE: A diet and physical activity program followed by a weight-loss maintenance program     may help obese black women lose weight. It is not yet known whether a weight-loss program is     more effective than a general health education program in helping obese black women lose     weight. Weight loss may reduce a person's risk of developing cancer.      PURPOSE: This randomized phase III trial is studying a weight-loss program to see how well it     works in helping obese black women lose weight.   "
229793|NCT00860002|"     Uterine leiomyomas (i.e., fibroids, myomas) are the most common gynecologic tumors in women     of reproductive age (1). Clearly, the majority of such lesions are asymptomatic (2). Symptoms     directly attributable to these benign tumors represent the most common reason for laparotomy     in non-pregnant women in the United States (3,4), and also in Taiwan (5). Whereas in decades     past, hysterectomy was seen almost as a panacea for uterine leiomyomas, more recently     attention has been paid to the development of pharmaceutical agents and less-invasive     procedures (6). Frequently, such procedures are designed to retain the uterus (6). Of these,     myomectomy may be a choice among the uterine-sparing treatments for symptomatic uterine myoma     (7,8).      The surgical mode of access usually employed in myomectomy is traditional exploratory     laparotomy or its modification—mini-laparotomy (MLT) (9) or ultra-mini laparotomy (UMLT)     (10,11), though recently, laparoscopy (12-14) or a combination of laparoscopy and MLT (9),     vaginal surgery (15), and hysteroscopic myomectomy (16-21) have represented valid     alternatives. However, myomectomy alone provides varying degrees of symptom control and a     high percentage of recurrence, not only for the tumors themselves, but also for the symptoms.     For example, one study reported that symptom resolution varied from 84.0% to 100% depending     on different items and 21 (19.4%) of 108 patients experienced a recurrence after an average     interval of 16 months (range, 1.8-47.4 months) (22). Therefore, an alternative or additional     therapy might be required to provide longer durable symptom control and minimize tumor     recurrence. One of the strategies is laparoscopic uterine vessel occlusion (LUVO), also known     as laparoscopic uterine artery occlusion (LUAO) (23,24).      The rationale for using LUVO in the management of symptomatic myomas is found in the     successful experience with uterine-artery embolization (UAE), which was introduced in 1995 as     an alternative technique for treating fibroids (25). Since then it has become increasingly     accepted as a minimally invasive, uterine-sparing procedure, and studies have reported the     relief of excessive menstrual bleeding or pressure in 80-90% of patients (26-32). LUVO     provided similar relief of symptoms (89.4% with symptomatic improvement and 21.2% with     complete resolution of symptoms) in 2001 in a 7- to 12-month follow-up of 87 patients after     LUVO (33).      Since that time there has been rapid growth in the use of this treatment with various     modifications, such as simultaneous accompaniment with myomectomy either through laparoscopy     or ML, and there has been considerable research into its outcome (22,34-42). However, in our     previous data, we found that a combination of LUVO and myomectomy provided definite     effectiveness in symptom control for these women with symptomatic uterine myomas (98.1% to     100% symptom resolution depending on various kinds of items), minimized tumor recurrence, and     rendered the vast majority of re-interventions unnecessary (22). Myomectomy can be performed     by the laparoscopic approach or by ML when patients are undergoing the LUVO procedure. Before     2002, we often used ML to perform myomectomy (22). However, we have shortened the incision to     less than 4 cm, creating ultramini-laparotomy (UMLT) to perform myomectomy (10,11,43).      Since many conservative therapies might provide less or more therapeutic effects on the     symptom control and disease status, the aim of this prospective study tries to evaluate the     therapeutic outcomes of these symptomatic uterine myomas after different kinds of therapies     in the coming 5 years at Taipei Veterans General Hospital.   "
229794|NCT00860015|"     In patients with unresectable soft tissue sarcoma, what is the response rate if treated with     Alimta and gemcitabine?   "
229795|NCT00860028|"     The purpose of this study is to determine whether extended pretreatment with varenicline     (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well     varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol     consumption.   "
229796|NCT00860041|"     RATIONALE: Gathering information over time from patients receiving paclitaxel for cancer may     help doctors learn more about pain caused by paclitaxel and plan the best treatment.      PURPOSE: This clinical trial is studying acute pain caused by paclitaxel in patients with     cancer.   "
229797|NCT00860054|"     Studies have shown that phytosterols will lower LDL cholesterol. Typical diets can contain     between 250 to 500 mg of naturally-occurring phytosterols. Long-term studies with     phytosterol-containing products(such as margarines) have not taken into account the amounts     of naturally occurring phytosterols in the diet. This means that the effects of small amounts     of natural dietary phytosterols on LDL cholesterol are not known. In this study, we will     examine the effects of phytosterols across a range of levels. The information will likely be     used to further support and possibly extend the current dietary recommendations for     phytosterol use.   "
229798|NCT00860067|"     The objective of this study was to show that quadrivalent live attenuated influenza vaccine     (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial     vaccine, FluMist.   "
229799|NCT00860080|"     The main purpose of this study is to determine whether three different single doses of PXL01     are safe and well tolerated by healthy volunteers. The pharmacokinetic properties of PXL01     (same doses) will also be investigated.   "
229800|NCT00860093|"     The purpose of this study is to evaluate the efficacy of MP-5971 in facilitating stone     passage after Shock Wave Lithotripsy treatment.   "
229801|NCT00860106|"     The purpose of this trial is to perform a prospective multicentric study to determine     predictive ED score and D-dimer level in the evaluation of the thromboembolic event     recurrence after anticoagulant treatment cessation.      The patients are included in the study from the anticoagulant treatment cessation. An ED     score and a blood sample are performed at this time and one month later. Then, the patients     are followed up by phone for 2 years.   "
229802|NCT00860119|"     This study tests the assumption that the bioavailability of alprazolam from a new sublingual     formulation is the same as that from a standard orally administered tablet.   "
229803|NCT00860132|"     The economic and social burden of hip fractures is expected to increase dramatically, but     financial resources remain limited. This calls for the investigation of innovative new forms     of organization and integration of medical, surgical and rehabilitation services for these     patients.      The study will investigate economical aspects associated with implementation of a     comprehensive orthogeriatric ward for elderly hip fracture patients in a general hospital,     compared with the classic model of orthopedic treatment followed by rehabilitation period.   "
229804|NCT00860145|"     This study will compare radiosurgery (focused radiation, Gamma Knife Radiosurgery) with     temporal lobectomy (standard surgical care) as a treatment of temporal lobe epilepsy.     Patients who have seizures that begin in their temporal lobe that are not controlled with     medications into the trial will be offered entry. Patients with a high likelihood of having     their seizures controlled with open surgery will have treatment randomized between the     standard surgery and radiosurgery. A prior study has shown that focused radiation     (radiosurgery) may also reduce or eliminate seizures arising from the temporal lobe. The main     study hypothesis is that radiosurgery is as safe and effective as temporal lobectomy in     treating patients with seizures arising from the medial temporal lobe.   "
229805|NCT00860158|"     This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk     localized prostate cancer.   "
229806|NCT00860171|"     This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody     BC8 when given before autologous stem cell transplant in treating patients with Hodgkin     lymphoma or non-Hodgkin lymphoma that has returned after a period of improvement or does not     respond to treatment. Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal     antibody BC8, can find cancer cells and carry cancer-killing substances to them without     harming normal cells. Giving iodine I 131 monoclonal antibody BC8 before an autologous stem     cell transplant may kill more cancer cells.   "
229807|NCT00860184|"     Atherosclerotic plaque at the carotid artery bifurcation is a major source of stroke. The     purpose of this investigation is to determine the ability of the SmartRisk software module to     predict stroke or stroke-related events due to carotid plaque within a high-risk population.     The SmartRisk software module operates on magnetic resonance images (MRI) of the carotid     artery wall.   "
229808|NCT00860197|"     This study will assess whether coffee consumption:        -  increases immune responses        -  decreases inflammatory status   "
229811|NCT00860236|"     A giardiasis outbreak in Bergen has given us the opportunity to approach two basic research     questions of national and global importance:        -  Studying the pathoimmunology of giardiasis in a natural setting, and following the          genetic and immunological responses leading to recovery or persistent disease and          sequelae.        -  Studying the two disease entities FGID and CFS when induced by acute giardiasi and their          risk factors.        -  Interventional cognitive behavioural therapy is the only intervention documented to have          significant effect on CFS outcome, and conventional cognitive behavioural therapy will          be compared to a psycho-educational programme in the format of a randomised controlled          trial.   "
229812|NCT00860249|"     The purpose of this study is to evaluate whether patient outreach is effective at increasing     compliance with preventative screenings for those patients who, based on national quality     standards, have become newly eligible for screening measures. We hypothesize that educational     outreach may increase completion rates.   "
229813|NCT00860262|"     The primary objective of this trial is to demonstrate that following eight weeks of treatment     the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line     therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the     monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe     hypertension. A key secondary objective is to identify the duration of treatment required to     demonstrate the superiority of the FDC over both of the monotherapies.   "
229814|NCT00860275|"     The purpose of the study is to determine if the concomitant administration of either     ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess     safety and tolerability of BMS-708163   "
229815|NCT00860288|"     This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes     patients receiving vildagliptin as add-on therapy to metformin   "
229816|NCT00860301|"     The purpose of this study is to investigate whether acupuncture influences:        -  the rate of infants who still fulfil the colic criterion after three intervention weeks        -  the time when the infants are crying, fussing or have intense bouts of colicky symptoms   "
229817|NCT00860314|"     The aim of this study is to identify the one electrode position out of two most commonly used     for external electrical cardioversion of typical atrial flutter, which needs less delivered     energy and less needed number of shocks for successful cardioversion.   "
229818|NCT00860327|"     Children who are born with heart defects undergo surgery when they are infants to correct the     defects. However, many treatments that are used in pediatric heart patients were originally     developed for adults and may not be the best option for children. This study will analyze     tissue samples from newborns and infants undergoing surgery for heart defects to learn more     about how a child's heart develops during the first year of life. This information may help     to identify possible treatments geared specifically for the pediatric heart patient.   "
229819|NCT00860340|"     To determine if the beneficial effect of spironolactone in patients with congestive heart     failure is in part due to its intrinsic inotropic action.      Randomized, two group placebo controlled, single blind study.   "
229820|NCT00860353|"     The purpose of this study is to determine how well tolerated and safe AZD2551 is at different     dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is     absorbed into and cleared by the body   "
229821|NCT00860366|"     The purpose of this study is to determine whether the combined treatment with Uric Acid and     rtPA is superior to rtPA alone in terms of clinical efficacy in acute ischemic stroke     patients treated within the first 4.5 hours of symptoms onset.   "
229868|NCT00860977|"     This study is a multicentre, randomized, placebo-controlled, fully blinded, clinical trial of     twice daily oral valacyclovir 500mg versus placebo with the goal of delaying the need for     initiating HAART among HIV infected individuals who neither use nor require HAART, and who     have not used chronic suppressive anti-HSV therapy for at least the 6 months prior to study     initiation.   "
229822|NCT00860379|"     The selenium status of children with major burns is suboptimal which may increase the     incidence of infection. Se requirements during critical illness are not known. Results from     this investigation may provide a tool for recommending Se supplements during burn injury.      The hypothesis of this research is that Se supplementation will restore the depressed Se     status among children with burn injuries. The secondary hypothesis is that Se status is     related to the incidence of infection among pediatric patients with burns.   "
229823|NCT00860392|"     This study will compare two approaches to the measurement of fatty acid oxidation (ketone     body flux and ketone body concentration) and determine which method demonstrates superior     sensitivity and variability in the detection of moderate increases in ketogenesis rates.   "
229824|NCT00860405|"     This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during     elective open-heart surgery in pediatric patients.   "
229825|NCT00860418|"     Young inner-city children with asthma have the highest emergency department (ED) visit rates.     Relying on the emergency department for asthma care can be a dangerous sign of poorly     controlled asthma. This research will focus on whether having a specialized asthma nurse join     the family at a child's doctor visit after an ED visit for asthma to make sure the child and     parent keep the follow-up appointment and have the nurse remind the child's doctor to     prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention)     will result in young children with asthma having fewer days with wheezing and cough.      The investigators hypothesize that:        1. Significantly more children receiving the PAAL intervention will attend greater than 2          non-urgent visits and greater than 6 refills for the child's anti-inflammatory          medications over 12 months when compared to children in the control or standard asthma          education group.        2. Children in the PAAL intervention group will experience less morbidity and caregivers          will experience increased quality of life compared to children in the control of          standard asthma education group.   "
229845|NCT00860678|"     A structured and supervised, 3-month physical activity intervention in patients after aortic     valve replacement due to severe stenosis, accompanied by examination of cardiac size and     function, exercise capacity and endothelial function before, three and six months after     operation; comparison with a non-intervention control group.   "
229826|NCT00860431|"     1. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to          standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD III-IV), on          time to first occurrence of any event of the triple composite outcome of initiation of          renal replacement therapy, decline of eGFR 50% or more or doubling of serum creatinine          (sCr) when compared with standard-of-care group;        2. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to GFR and          proteinuria;        3. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to health related          quality of life;        4. To evaluate the safety and tolerability of long-term AST-120 therapy in patients with          CKD;        5. To evaluate the all-cause mortality and hospitalization apart from those planned for          operation and intervention)   "
229827|NCT00860444|"     Cardiovascular disease (CVD) is a serious health problem among African American women. This     study will evaluate a health care center-based program that aims to encourage African     American women to eat a low fat diet and increase their physical activity levels to reduce     the risk of developing CVD.   "
229828|NCT00860457|"     This study is for patients with chronic lymphocytic leukemia (CLL) who have not yet received     any treatment for their disease.      Current therapy for this disease includes the use of combination chemotherapy regimens     containing Fludarabine and Rituximab, which have been found to be very effective for CLL. In     this study, subjects will receive Fludarabine and Rituximab. After 3 cycles or 6 cycles of     Fludarabine and Rituximab treatment, they will receive Lenalidomide. We are doing this     research because we are attempting to improve the response, or outcome, of Fludarabine and     Rituximab in previously untreated CLL patients. Lenalidomide is a drug that alters the immune     system and it may also interfere with the development of tiny blood vessels that help support     tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells.     Lenalidomide is approved by the Food and Drug Administration (FDA) for treatment of specific     types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients     with multiple myeloma (MM). MDS and MM are blood disorders that involve different types of     blood cells. It is not approved for chronic lymphocytic leukemia. It is currently being     tested in a variety of cancer conditions. In this case it is considered experimental.      This research is being done because we are attempting to find a better treatment for chronic     lymphocytic leukemia. We do not know the effect of Lenalidomide following the regimen of     Fludarabine and Rituximab.      The hypothesis of the study is that adding Lenalidomide after the standard treatment regimen     of Fludarabine and Rituximab will have better outcomes than treatment with Fludarabine and     Rituximab alone.   "
229829|NCT00860470|"     The purpose of this community-based randomized trial is to examine whether a daily antenatal     and postnatal multiple micronutrient supplement given to women will enhance newborn and     infant survival and health and other birth outcomes in a rural setting in northwestern     Bangladesh.   "
229830|NCT00860483|"     The purpose of the research is to determine how practicing laparoscopic motor tasks affects     the functional anatomy of the brain, and to investigate whether there is a correlation     between surgical experience and functional brain activition. Additionaly, the investigators     plan to use eye-tracking technology to see if the use of this technology can distinguish     surgeons of various skill levels. The investigators hope that this study leads to new and     effective methods of training surgical residents. All of the data will be collected at The     Feinstein Institute for Medical Research, and may be used in future studies, which may or may     not be related to urological diseases.   "
229831|NCT00860496|"     A new immunosuppressive drug, based on the inhibition of important enzymes in the immune     system, called JAK, is being developed by Pfizer to prevent transplant rejection. Since many     treatments for transplant rejection may be administered together, this research study will     analyze the effects of common transplant rejection therapies, Tacrolimus and Cyclosporine, on     the JAK inhibitor, CP-690,550.   "
229841|NCT00860626|"     For HBeAg(+) patients, interferon is used for 12 weeks. On 12th week of treatment, If HBV DNA     is undetectable (<1000 copies/ml), interferon is continued alone for one year. If HBV DNA is     still positive, nucleoside analogue is added for 3 months. After nucleoside analogue is added     for 3 months, HBV DNA is tested again. If negative, stop nucleoside analogue and use     interferon alone for another 6 months or longer. If HBV DNA is still positive, change to     another nucleoside analogue or add another nucleoside analogue.   "
229832|NCT00860509|"     The objective of this study is to compare cholesterol absorption and metabolism after feeding     diets naturally low or high in phytosterols. All meals will be prepared in a metabolic     kitchen and analyzed for phytosterols. In a randomized crossover design a group of up to 25     healthy subjects will consume diets containing either 100 mg/day or 600 mg/day phytosterols     for 4 weeks. At the end of each dietary period percent cholesterol absorption, fecal     cholesterol excretion and LDL cholesterol level will be measured. The hypothesis is that LDL     cholesterol and cholesterol excretion will be improved on the high phytosterol diet even     though macronutrient composition, mineral intake and fiber consumption are similar.   "
229833|NCT00860522|"     This is a Phase 1, open-label, dose escalation study of JVRS-100. The study will proceed in 2     stages to minimize the number of patients treated at doses substantially below the     recommended phase 2 dose. In stage 1, an accelerated titration schema will be followed with     one patient at each dose level. Stage 2 will commence after a dose limiting toxicity is     observed in stage 1 or after the maximum dose for stage 1 is reached. Stage 2 will follow a     modified Fibonacci schema with 3-6 subjects at each dose level until a recommended phase 2     dose is determined. The cohort will then be expanded to a maximum of 12 patients to more     fully evaluate the recommended phase 2 dose.   "
229834|NCT00860535|"     This study will evaluate a gene expression signature (Growth Factor Signature [GFS]) as a     biomarker for response/resistance to BRC-ABL oncogene inhibitors.   "
229870|NCT00861003|"     This prospective study examines the differences among several measures of adherence to     antipsychotic medications in outpatients with schizophrenia. Adherence is assessed by using     self-report, physician report, pill count and electronic monitoring. The rates of     adherence/non-adherence with various tools will be manifested. The association between     antipsychotic adherence/non-adherence and various clinical status, including psychotic     symptoms, depressive symptoms, side effects, neurocognitive function and insight are     analyzed. Participants are assessed at baseline during a visit to their outpatient clinic and     followed up for 8 weeks.   "
229835|NCT00860548|"     The Scleroderma Cyclophosphamide Or Transplant (SCOT) Trial is a Phase II/III interventional     trial comparing two treatments for early, severe scleroderma. These two interventions are     high dose immunosuppressive therapy followed by autologous stem cell transplantation and     monthly high dose pulse cyclophosphamide (the later for 12 doses). While standard of care     might be considered the optimal control arm for a trial such as this one, no such standard of     care is available for the population of scleroderma patients defined by the eligibility     criteria for this trial. The rheumatologists on the protocol team believe that the SCOT     cyclophosphamide regimen represents the best control arm for this study. However, given     concerns over use of a treatment arm as a control that has not been established as a standard     of care, this registry was established. The registry will be a prospective, observational     study of subjects with severe systemic sclerosis (SSc) who are eligible to participate in the     Scleroderma Cyclophosphamide or Transplantation (SCOT) Study but are denied insurance     coverage or decline to participate prior to randomization. Subjects will be accrued over the     same period as the SCOT study. Subjects will follow the course of treatment prescribed by     their treating physician with no interference from the registry.      The primary purpose of this study is to document the disease course and outcome in a group of     participants who are eligible for the SCOT study, but declined to participate, in order to     determine whether their outcome is better, worse, or no different than those who participate     in the treatment phase of the trial.   "
229836|NCT00860561|"     This PMS aims to assess the efficacy, the safety and tolerability profile of Faslodex in     everyday practice. Secondary objective of this PMS is to identify the frequency of serious     adverse events or any unknown adverse events of Faslodex.   "
229837|NCT00860574|"     This phase II trial is studying how well giving treosulfan together with fludarabine     phosphate and total-body irradiation followed by donor stem cell transplant works in treating     patients with high-risk acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic     leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body     irradiation before a donor bone marrow or peripheral blood stem cell transplant helps stop     the growth of cancer cells. It may also stop the patient's immune system from rejecting the     donor's stem cells. The donated stem cells may replace the patient's immune cells and help     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     tacrolimus and methotrexate before and after transplant may stop this from happening   "
229838|NCT00860587|"     The objectives of the study were:        1. To study risk factors for colonization and infection with antibiotic resistant bacteria          among patients with severe IAI before and after antibiotic treatment and surgical          intervention.        2. To study species changes in the rectal flora among patients with severe IAI before and          after antibiotic treatment and surgical intervention.        3. To review guidelines for antibiotic use in participating units.        4. To evaluate surgical antibiotic prophylaxis and treatment in relation to risk for          colonization and infection with antibiotic resistant bacteria among patients with severe          IAI        5. To use the results from the study in the process of a more appropriate use of          antibiotics in participating units and care of patients with severe IAI.        6. To study the dynamics of extended-spectrum beta-lactamase producing and wild-type          Enterobacteriaceae in patients with suspected severe intra abdominal infections before,          during and after antibiotic treatment.   "
229839|NCT00860600|"     This was a phase II multi-center, randomized, open-label study with two parallel study groups     to evaluate the efficacy and safety of PG2 in ITP patients.   "
229840|NCT00860613|"     No dietary strategies have been designed and proved for Mexican pregnant women with diabetes.     This is a randomized clinical trial of pregnant women with pregestational type 2 diabetes and     gestational diabetes that were followed every two weeks until labor to assess the impact of     the MNT program on metabolic control, maternal and fetal nutritional status and cost     effectiveness. Participants were randomly assigned to one of three medical nutrition therapy     (MNT) groups: the MNT 1 group (n=38) received usual medical treatment, counseling from a     nutritionist and diabetes educator, using carbohydrate counting (40-45% of carbohydrates)with     an intensive educational component; MNT2 group (n=50) had the same treatment, but included     only low-moderate glycemic index foods; and NO-MNT group (n=45) received the current hospital     treatment. All women will receive a glucose meter so they do self glucose monitoring (pre and     postprandial) 2 times a weeks 6 times a day. Weight gain, dietary consumption and glucose     concentrations will be evaluated every two weeks. Fetal outcomes (weight, length and presence     of complications)will be measured at labor.   "
229842|NCT00860639|"     The main objective of the study is to improve outcome of younger patients (between 18-60     years) with acute myeloid leukemia and intermediate risk defined by the cytogenetics. In this     population, in the absence of bone marrow transplantation, event free survival (EFS) is     estimated at 35% after three years of follow-up. Adjunction of gemtuzumab ozogamycin     (MYLOTARG®) to standard chemotherapy is supposed to increase EFS up to 50% at 3 years. To     test this hypothesis, the Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang     (GOELAMS ) sponsored by Nantes University Hospital leads this randomized open phase III trial     in 29 French centers.   "
229843|NCT00860652|"     Radical prostatectomy (RP) is the most common curative approach offered to men with newly     diagnosed prostate cancer. Unfortunately, up to half of these patients will have factors     placing them at high risk of their cancer recurring. Having radiotherapy after RP is known to     improve cure rates, but what is not known is whether it should be given straight after the     operation or only when there is a rising PSA after surgery indicating active cancer.     Immediate RT may not benefit all men, and can cause serious side effects such as bladder and     bowel problems and impotence. International lack of consensus on the optimal timing of RT has     resulted in varied clinical practice. This phase 3 trial will compare the two approaches.   "
229844|NCT00860665|"     Screening colonoscopy has been established as the most effective means of colorectal cancer     prevention. This is based on the fact that colonoscopy detects and removes colonic polyps     (adenomas) which are known to progress to cancer if left untreated. The present study     examines the question whether case volume (i.e., the number of colonoscopies performed per     year) correlates with colonoscopy quality, i.e., adenoma detection rate.   "
229846|NCT00860691|"     The purpose of this study is:        -  to determine neutrophil activity in patients with colon cancer,        -  to determine levels sFas, sFasL and IL - 17 in serum of healthy volunteers and colon          cancer patients and establish its prognostic value,        -  to elucidate the relationship between serum sFas, sFasL and IL - 17 levels and          clinicopathologic features of colon cancer,        -  to compare the influence of laparoscopic and conventional procedures on postoperative          serum sFas and sFasL levels in colon cancer patients        -  to compare the influence of laparoscopic and conventional procedures on postoperative          serum IL - 17 levels in colon cancer patients        -  to compare the influence of laparoscopic and conventional procedures on postoperative          neutrophil functions        -  to confirm the expression of FasL protein in human colorectal cancer and elucidate the          relationship between FasL expression and clinicopathologic features of the disease, to          establish the prevalence of Fas in primary colon adenocarcinomas and elucidate the          relationship between FasL expression and clinicopathologic features of the disease        -  to determine the functional activity of tumour infiltrating neutrophils   "
229847|NCT00860704|"     Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese     patients.   "
229848|NCT00860717|"     Neuropathic ulcers are common sequelae of leprosy. The objectives of this study are to     analyze the clinic-epidemiological characteristics of patients attended at one specialized     dressing service from a leprosy-endemic region of the Brazilian Amazon and to evaluate the     effect of Low Level Laser Therapy on wound healing of these patients.   "
229849|NCT00860730|"     The clinical investigation is designed as a prospective and non-randomised study on a maximum     of 150 patients. This study will be conducted at Investigational Centres in the European     Community. A minimum number of 8 European Centres will be involved in the clinical     investigation. A minimum of 15 patients will be enrolled at each Investigational Centre. The     clinical follow-up requires evaluations at discharge (or 30 days if the patient is still     hospitalized), 3-6 and 12 months following the procedure.The primary objective of this     clinical investigation is to assess the performance of the Perceval S valve at 3-6 months     after implantation in high surgical risk patients, who require a surgical intervention to     replace the aortic valve.   "
229850|NCT00860743|"     The prevalence of obstructive sleep apnea is high in the Veteran population. If not treated     promptly, sleep apnea may result in daytime fatigue which may lead to increased prevalence of     accidents while driving or in the workplace. Recent large scale epidemiological studies have     shown that the prevalence of excessive daytime sleepiness increases in individuals who suffer     from obstructive sleep apnea. Obstructive sleep apnea may also result in the development of     hypertension and other cardiovascular disorders. Previous findings have shown that subjects     with sleep apnea have a greater risk for developing coronary vascular disease compared to     individuals that do not suffer from sleep apnea Thus, a significant amount of evidence     suggests that sleep apnea is a major health concern in the Veteran population. Consequently,     determining the mechanisms that may impact on the severity of sleep apnea and increase the     prevalence of cardiovascular incidents associated with this disorder is important, as is     discovering novel treatments.   "
229851|NCT00860756|"     Hypotheses:        -  Hypothesis 1 - Sleep can be measured in Theater using actigraph technology.        -  Hypothesis 2 - Standard sleep measures in Soldiers randomized to a sleep intervention          group will more closely approximate normal as compared to sleep measures of Soldiers          randomized to the control group.   "
229852|NCT00860769|"     The purpose of this randomized pilot study was to conduct an intervention with 68 rural women     living with AIDS to compare the effectiveness of two different programs on compliance with     HIV/AIDS treatment regimens, improvement in knowledge about HIV/AIDS and TB, improvement in     psychological distress, reduction in stigma; satisfaction with care provided to family     members, reduction in number of opportunistic infections, increase in CD4 levels and     completion of the designed Asha-Life (AL) program. The trial was designed to assess the     impact of the Asha-Life (AL) intervention engaging with an HIV-trained village woman, Asha     (Accredited Social Health Activist), to participate in the care of women living with AIDS     (WLA), along with other health care providers compared to a Usual Care group. Two high     prevalence HIV/AIDS villages in rural Andhra Pradesh, which were demographically alike and     served by distinct Public Health Centers, were selected randomly from a total of 16 villages.   "
229854|NCT00860795|"     The goal of this study is to determine if Echinacea purpurea stimulates the immune system.     For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo     for 10 days. Blood will be drawn to assess immune markers just before beginning the study     medication, during the 10 day course of medication and after completing the course of     medication. It is postulated that adults receiving the Echinacea will have evidence of immune     stimulation and those receiving placebo will not.   "
229855|NCT00860808|"     The purpose of the study is the evaluation of the therapeutic benefit of intratympanic AM 101     injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus     following acute sensorineural hearing loss.   "
229856|NCT00860821|"     The purpose of this methodology study is to evaluate the effect of AZD8309 on cells and     inflammatory biomarkers in nasal lavage and blood after nasal challenge with     lipopolysaccharide (LPS)   "
229857|NCT00860834|"     Parents of children with asthma must work with their child's pediatrician to ensure that     their child's asthma is managed well. Asthma coaches are one way to facilitate and support     the relationship between parents and pediatricians. This study will evaluate whether access     to a 12-month telephone asthma coaching program for parents is an effective way to improve     asthma outcomes in children.   "
229871|NCT00861016|"     This is an open-label, non-comparative, multi-centre clinical study to evaluate the Efficacy     and safety of Metoprolol Succinate prolonged-release tablet (Betaloc Zok) in patients with     mild to moderate essential hypertension.   "
229872|NCT00861029|"     This is a Phase I, randomized, double-blind, placebo-controlled, study to estimate the     effects of daily oral dosing of 800 mg pazopanib on electrocardiographic parameters (QTc     interval duration) as compared with placebo in subjects with solid tumors. Moxifloxacin, will     serve as a positive control.   "
229873|NCT00861042|"     The primary objective of the trial is to assess the tolerability and safety of long-term SPM     927 administration in subjects with diabetic neuropathy.   "
229858|NCT00860847|"     1. Statement of Problem           According to the National Fire Protection Association (NFPA), 43.7% of all firefighters          that died on the job experienced sudden cardiac death. The job also affords an          incredible amount of stress. Cholesterol therapy has been well demonstrated to reduce          coronary plaque progression. However is certainly not the only factor in evaluating for          progression of coronary artery disease (CAD), and other factors must play a role. Garlic          therapy has been shown to retard atherosclerosis independently.        2. Hypothesis and Specific Aims The hypothesis of this proposal is: In comparison to the          placebo group, Aged Garlic Extract (AGE) therapy + Coenzyme Q10 (CoQ10) will be          effective in slowing progression of coronary artery calcification (CAC) in firefighters          with established atherosclerosis, independent of baseline blood pressure, statin use or          other cardiovascular risk factors.      Specific Aims:        1. Compare the effects of cholesterol lowering effects in a firefighter population of          patients under the influence of Aged Garlic Extract + CoQ10 or placebo.        2. Compare whether degree of change in atherosclerotic coronary artery plaque burden will          change at a different rate under the influence of Aged Garlic Extract + CoQ10 compared          to placebo treatment.        3. Compare whether Aged Garlic Extract + CoQ10 therapy induces changes in baseline values          including biological and biochemical parameters, such as LDL cholesterol, homocysteine,          C-reactive protein (CRP), and endothelial function.   "
229859|NCT00860860|"     This study will investigate the toxicity, safety and pharmacokinetics of pretargeted     radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled     di-HSG-DOTA peptide IMP-288. Furthermore, the sensitivity of pretargeted imaging with     In-111-labeled IMP-288 as compared to standard methods of tumor detection, and the     preliminary efficacy of the therapy.   "
229860|NCT00860873|"     This study objective is to check the non-inferiority of the 2 formulations produced by EMS     when compared with the same substances and pharmaceuticals forms of the product Condroflex     (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and     functional capacity that will be periodically measured by using the Visual Analog Scale of     pain (VAS) and the questionnaire of Lequesne.   "
229861|NCT00860886|"     Background:        -  Incidence of breast cancer is very low in Mongolia (6.6/100,000), especially in rural          areas. Over the past 15 years, there has been considerable economic growth in Mongolia,          resulting in migration to urban centers such as the capital, Ulaanbaatar, from areas          with nomadic or semi-nomadic lifestyles. This recent migration offers an opportunity to          study the endocrine profiles of premenopausal women as they acculturate to a more          Western lifestyle.      Objectives:        -  To obtain new data on premenopausal endocrine and growth factor concentrations to assess          possible variations by migration status within Ulaanbaatar; that is, to compare women          who have been living in Ulaanbaatar for the longest period of time with those who have          recently moved to Ulaanbaatar.        -  To compare data from Mongolia with data from the United States (and possibly China),          where women are at higher risk of breast cancer.      Eligibility:        -  A sample of 375 premenopausal women will be drawn from a larger sample of mothers whose          children are participating in a study conducted by Harvard Medical School. Only mothers          of girls will be included in this cross-sectional study. Women ages 25 44 years who are          not pregnant or breastfeeding are eligible.      Design:        -  A total of 30 ml (three 10 ml samples) of whole blood will be collected. Women will be          asked to provide a spot urine sample. These samples will be sent periodically to the NCI          biorespository during the course of the study for testing. A portion of a sample for          each participant will be kept in Ulaanbaatar in case of problems in delivery to the          United States.        -  The following hormones will be evaluated: testosterone, androstenedione,          dehydroepiandrosterone (DHEA), DHEA-sulfate, estrone, estradiol, estriol, progesterone,          prolactin, placental lactogen, IGF-1 and IGFBP-3, VEGF, soluble endoglin, and possibly          other angiogenic proteins.        -  Socioeconomic status and medical and lifestyle information will be assessed by          questionnaire, including ethnicity, occupation, education, and migration status (e.g.,          whether she moved from a rural area and time since migration). Breast cancer risk          factors such as age at first pregnancy, age at first menstruation, gravidity (total          number of pregnancies), parity (total number of childbirths), smoking status, alcohol          use, and dietary intake will also be determined. (These questionnaires will have been          pilot tested and revised before the start of this study.) The Global Physical Activity          Questionnaire, developed by the World Health Organization, will assess physical          activity.        -  Mean and median premenopausal hormone concentrations of previously collected blood          samples from women in the United States who are at high breast cancer risk will be          compared with the Mongolian samples. In addition, Chinese data will be compared if          available.   "
229862|NCT00860899|"     The purpose of this study was to investigate hypothesis that preoperative administration of     epidural clonidine will reduce postoperative pain and systemic inflammatory stress response     better than epidural levobupivacaine.   "
229863|NCT00860912|"     The purpose of this study is to evaluate the Veritas Collagen Matrix in treating female     patients with documented occurence of Pelvic Organ Prolapse as evidenced by a cystocele.   "
229864|NCT00860925|"     Major non-cardiac surgeries are common and major heart problems during or after such     surgeries represent a large population health problem. Few treatments to prevent heart     problems around the time of surgery have been tested.      There is encouraging data suggesting that low-doses of Acetyl-Salicylic Acid (ASA) and     Clonidine, which are two medications, given individually for a short period before and after     major surgeries may prevent major heart problems.   "
229865|NCT00860938|"     Study purpose is to evaluate if subjects with chronic obstructive pulmonary disease (COPD)     are more likely to be responsive to additional inhaled corticosteroids if they have a     positive response to hyperosmolar challenge with mannitol than if their response is negative.   "
229866|NCT00860951|"     The purpose of this research is to develop tools enable people who are paralyzed to operate     technology and access computers. These tools are called brain computer interfaces (BCIs).     BCIs would let a person use brain signals to operate technology.   "
229869|NCT00860990|"     Spinal cord injury (SCI) often results in reduced bowel function and regularity, leading to a     decrease in quality of life for those who are affected. Evidence-based research has indicated     that, when surveyed, individuals with SCI express a greater reduction in quality of life     derived from their bowel routine than able-bodied subjects. In addition, the extent of     reduction in quality of life has a direct relationship with the level of Injury. Those with     tetraplegia score worse than those with paraplegia and paraplegics score worse than controls.     The development of an adequate quality of life questionnaire is needed to effectively     identify the impact of bowel care on quality of life in patients with SCI compared to     able-bodied controls. The purpose of this study is to determine the discriminatory ability of     the survey for various diagnoses such as SCI, CVA, TBI, chronic back pain, radiculopathy from     the Rehabilitation Service and able bodied persons.   "
229906|NCT00861484|"     The purpose of this study is to determine if the administration of GSK958108 can delay     ejaculation in patients with primary premature ejaculation as measured by the ejaculatory     latency time (ELT) using the masturbation model and sexual visual stimulation, and to     evaluate the safety and tolerability of GSK958108 in healthy men with PE   "
229874|NCT00861055|"     In the proposed study, the investigators plan to establish the burden of early onset (EO)     neonatal sepsis in the newborn population born at Maela Refugee Camp over a two year period.      Aims        1. Define the contribution of Group B streptococcus(GBS) to this problem by establishing:             -  The prevalence of maternal GBS carriage             -  The prevalence of culture positive and culture negative EO GBS sepsis             -  The perinatal risk factors for EO GBS cases        2. Through these data assess the potential for intrapartum antibiotic prophylaxis using          different strategies for reducing the burden of neonatal sepsis in this setting        3. To define the serotypes and antibiotic susceptibility profile of carried and invasive          GBS strains        4. To evaluate the prevalence of serum antibodies to common GBS capsular serotypes in          pregnant women in this population, the influence of carriage on serotype (ST)-specific          antibody and the ST-specific antibody concentrations in the mothers of cases of          confirmed and clinical GBS disease.   "
229875|NCT00861068|"     The objective of the trial is to investigate the analgesic efficacy of SPM 927 in subjects     with moderate to severe neuropathic pain due to Postherpetic Neuralgia (PHN)   "
229876|NCT00861081|"     The purpose of this study is to test a newly developed outpatient care intervention called     SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke     preventive services at Los Angeles County hospitals and to measure the costs of running such     an intervention.   "
229877|NCT00861094|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) together with radiation     therapy may kill more tumor cells.      PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different     combination chemotherapy regimens to compare how well they work as first-line therapy in     treating patients with esophageal cancer that cannot be removed by surgery.   "
229878|NCT00861107|"     This is a Phase I/II study to investigate the feasibility of creating a personalized     therapeutic cancer vaccine within the body. A vaccine contains a source of tumor antigen and     an adjuvant. In this study, tumor antigen is generated by freezing a tumor by a minimally     invasive percutaneous (through the skin) cryoablation procedure. The study drug, AlloStim, is     injected into the ablated tumor to promote development of an anti-tumor immune response.   "
229879|NCT00861120|"     The purpose of this study is to investigate the response rate in platinum-resistant, KRAS     wild-type, ovarian cancer patients who are treated with pegylated liposomal doxorubicin     (Caelyx®) in combination with biological treatment panitumumab (Vectibix®).   "
229880|NCT00861133|"     The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will     enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.   "
229881|NCT00861146|"     The majority of individuals with alcohol problems remain current smokers, and the negative     health consequences of smoking among these individuals are substantial. This study will     investigate the impact of smoking cessation interventions initiated during intensive alcohol     treatment on processes reflecting risk of alcohol relapse.   "
229882|NCT00861159|"     It is the investigators aim to determine the feasibility of directly detecting anti-RLIP76     auto-antibodies in human serum using prepared RLIP76 antigen peptides in persons with     rheumatologic disease and persons without rheumatologic diesease (healthy subjects).   "
229883|NCT00861172|"     It is difficult to determinate prognostic criteria of Multiple Sclerosis with conventional     MRI insofar as physiopathology is not well-known: the precise sequences of events leading to     plaque formation and axonal injury are still not completely understood.      Some elements involved in plaque formation can be studied thanks to MR techniques     (cerebrospinal fluid and periveinular spaces, neuronal injury, microglia, and cerebral     microcirculation's dysfunction).      This study aims at giving a better understanding of MS plaques' physiopathology, using data     from modern MRI through a longitudinal followed up with weakly MR 3T examination.   "
229884|NCT00861185|"     The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates     exercise induced asthma symptoms.   "
229885|NCT00861198|"     At the time of endoscopic retrograde cholangiopancreatography (ERCP) examination of the     pancreaticobiliary system is done indirectly by radiologic means. Contrast is injected into     the bile and/or pancreatic duct and outline of the duct is then viewed by fluoroscopic     imaging. Frequently this is followed by diagnostic maneuvers (tissue acquisition) or     therapeutic interventions (stone removal, stent insertion). Direct visualization of the bile     and pancreatic ducts (cholangioscopy/pancreatoscopy) was developed 15 years ago and was shown     to be superior to the indirect radiological view. The procedure did not become widely used     secondary to high procedure related costs and equipment prone to failure. Recently a much     improved (more affordable and more durable) cholangioscope was developed and approved by the     FDA. The goal of this study is to prospectively record our experience with cholangioscopy and     pancreatoscopy performed as medically indicated as part of standard medical care.   "
229886|NCT00861211|"     The purpose of the study is to determine whether senicapoc can decrease changes in FEV1     following allergen challenge in atopic allergic subjects.   "
229887|NCT00861224|"     This study was conducted in conjunction with the 2 phase 3 studies of AMG 531 (20030105 and     20030212) and an open-label extension study (20030213) and compared pretreatment and     posttreatment bone marrow samples for the purpose of studying morphologic changes.   "
229888|NCT00861237|"     After heart surgery, about 30% of patients suffer from atrial fibrillation. Patients are     randomized into two groups receiving either potentized Strychnos Nux vomica or placebo under     double blind conditions. Postoperatively, ECGs are done to monitor cardiac rhythm.   "
229889|NCT00861250|"     The primary objective of this study is to determine the rate of molecular remissions (MolR)     assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone     (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation     (HDT-ASCT), and after HDT-ASCT in patients with multiple myeloma.   "
230105|NCT00866554|"     The purpose of this study is to determine if a combination of neoadjuvant dutasteride and     bicalutamide has the same efficacy and less toxicity than standard treatment with an LHRH     agonist and bicalutamide for prostate cytoreduction prior to permanent implant brachytherapy.   "
229890|NCT00861263|"     Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of     disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI     tract, which can prove difficult to visualize during an endoscopy specifically designed to     evaluate it, termed enteroscopy. Thus, the FDA has approved overtubes, such as the Endo-Ease®     spiral overtube (Spirus Medical, Inc.) or EnteroPro® balloon overtube (Olympus Medical,     Inc.), to facilitate passage of the endoscope through the GI tract. The aims of the study are     to evaluate the efficiency of an overtube system for visualization of small bowel. The     hypothesis is that this will permit more complete and efficient evaluation of the small     intestine.   "
229891|NCT00861276|"     Objective: To assess the impact of instructional guidance in the regular use of use nicotine     nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation     for heavy smokers who are willing to quit.      Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers,     were willing to quit, and attending an academic outpatient clinic in Western Switzerland.     Patients were randomised to instruction on NNS use as ad libitum (administration whenever     cravings appear; control group) or to use NNS at least every hour when awake (intervention     group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM)     during the first three weeks of use. Self reported abstinence from smoking at six months was     confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect     GLS regression was used to calculate the mean difference of daily doses between groups     controlling for lack of independence between measures from the same individual.   "
229892|NCT00861302|"     This interventional study seeks to evaluate the overall outcomes of a novel, emotional     awareness intervention for people with chronic musculoskeletal pain and determine which     patients benefit the most from this intervention. The investigators also are evaluating the     effects of brief emotional communication technique embedded in the pre-treatment assessment.   "
229893|NCT00861315|"     Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order     to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine     the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close     to but inferior to those observed after standart intravenous amikacin infusion.   "
229894|NCT00861328|"     Treatment of cancer is often improved if two or more drugs are used in combination. In animal     studies, the use of the combination of ON 01910.Na (a new, unapproved drug) and irinotecan or     oxaliplatin (two approved and extensively used anti-cancer drugs) gave better results against     tumor cells than the use of any of the single drugs alone. In addition, the use of the     combinations did not result in an increase of side effects. This clinical trial will     determine what is the highest dose of ON 01910.Na that can be given safely in combination     with either irinotecan or oxaliplatin in human patients.   "
229895|NCT00861341|"     The purpose of this study is to determine how pioglitazone and aspirin affect platelets in     the blood of diabetic and non-diabetic subjects. Platelets are small cells in the blood that     help with blood clotting. Pioglitazone is a drug that is used to lower blood sugar and fats     by helping the body to use insulin correctly. Pioglitazone is presently used to treat     diabetes but has not been approved for non-diabetics. This study will determine whether     pioglitazone reduces the activity of platelets in people who are or are not also taking     aspirin.   "
229896|NCT00861354|"     This study assess the accuracy of a blood pressure monitor designed to detect atrial     fibrillation. Subjects use the blood pressure monitor on a daily basis for 30 days and     compare the readings to an ECG done at the same time.   "
229897|NCT00861367|"     Aspirin is very common in older patients. Therefore many of the investigators patients have     aspirin. The aim of the study is to proof that Transurethral Surgery of the bladder or the     prostate can be performed with aspirin.   "
229898|NCT00861380|"     The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal     conjugate vaccine (GSK1024850A), administered according to different vaccination schedules,     against invasive disease caused by S. pneumoniae or H. influenzae as well as vaccine impact     on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and     outpatient antimicrobial prescriptions.      This study will also explore vaccine impact on occurrence of respiratory tract infections     (RTIs), including acute otitis media (AOM) in a subset of children in Turku area.   "
229900|NCT00861406|"     The goal of this clinical research study is to find the best dosing schedule of a combined     treatment of PEG Intron® (pegylated Interferon-alfa 2b) plus a peptide vaccine (gp100) that     may help improve immune response in patients that had Stage II or Stage III melanoma and are     free of the disease. The safety and tolerability of this drug combination will also be     studied. Researchers also want to collect long-term follow-up information.   "
229901|NCT00861419|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG     386 when used in combination with AMG 706, bevacizumab, sorafenib, or sunitinib and that at     least one dose level from each combination will be safe and well tolerated.      AMG 386 is a man-made medication that is designed to stop the development of blood vessels in     cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called     angiogenesis, to obtain a supply of oxygen and nutrients to grow.   "
229902|NCT00861432|"     Tumor patients receiving conventional tumor therapies are included into this study. The     patients are randomized into two groups receiving either additive homeopathic therapy or not.     Two questionnaires referring to subjective feeling and life quality are filled out by the     patients with each visit to the outpatients Department. One of them is the QLQC30     questionnaire of the EORTC. The results of the questionnaires of the two groups are compared.   "
229903|NCT00861445|"     The primary purpose is to investigate the safety and efficacy of SPM927 in patients with     Painful Diabetic Neuropathy   "
229904|NCT00861458|"     This study will test two different formulations. The results will be used to select     formulation for phase 3.   "
229905|NCT00861471|"     This trial is designed to determine the proper doses of Docetaxel and Imatinib mesylate to be     used to treat hormone refractory prostate cancer and to evaluate the safety and efficacy of     the treatment.   "
230106|NCT00866567|"     The purpose of the study is to characterize innate immune function of premature infants, and     identify defects that may be responsible for the development of bacterial sepsis.   "
229908|NCT00861510|"     Background:        -  Mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM),          and other lymphoid malignancies are all incurable lymphoid malignancies that mainly          affect persons in their late 60s and early 70s. Conventional chemotherapy can achieve          high rates of clinical response, but relapse following these responses is almost          universal. Patients with lymphoid malignancies relapse because their tumor cells become          resistant to chemotherapy; therefore, new types of drugs are needed for better treatment          responses.        -  The investigational drug ON 01910.Na has been shown to be active against MCL and CLL          cells, but further research is needed to determine the most safe and effective dose for          this drug.      Objectives:        -  To determine the maximum tolerated dose (the highest dose that does not cause          unacceptable side effects) of ON 01910.Na in patients with cancers of the lymphoid          cells.        -  To study the effects that ON 01910.Na has on cancers of the lymphoid cells.      Eligibility:        -  Patients 18 years of age and older who have been diagnosed with cancer of the lymphoid          cells, and who have not been able to take or have not benefitted from existing treatment          options.      Design:        -  Evaluations before the treatment period:        -  Full medical history and physical examination, and pregnancy test for women.        -  Blood and urine tests.        -  Disease evaluation with computerized tomography (CT) scan, magnetic resonance imaging          (MRI), electrocardiogram; bone marrow and lymph node biopsies; and skeletal x-rays, if          clinically indicated.        -  Treatment with ON 01910.Na:        -  Different research subjects will receive increasing doses of ON 01910.Na to determine          which dose is considered safe.        -  To reduce the risk of one rare serious side effect of treatment for myeloid          malignancies, patients will take allopurinol 12 hours before and 7 days after each drug          infusion, one 300 mg pill each day.        -  Cycles 1 2: Patients will be admitted to the clinical center for 2 days at the beginning          of each cycle. Each cycle involves intravenous infusion of ON 01910.Na continuously for          a period of 48 hours, followed by 12 days of observation. Researchers will try to          maintain the schedule of 2 days of infusion every 14 days, but the interval between          doses may be extended if patients experience delayed recovery blood counts.        -  Cycles 3 4: Patients who are doing well and choose to continue may receive an additional          two cycles (2 days of inpatient infusion followed by 12 days of outpatient observation).          At the end of cycle 4, researchers will determine if the disease is responding to          therapy. Patients who experience side effects may continue to take ON 01910.Na at a          lower dose or may stop receiving the drug.        -  Patients who respond well to four cycles of ON 01910.Na may be eligible for additional          cycles of ON 01910.Na.        -  Patients who need to start another medication to treat their disease will stop taking ON          01910.Na, and the researchers will perform a final study visit 2 weeks after the last          dose of ON 01910.Na. After that, participation in the study will be complete.   "
229909|NCT00861523|"     There are different treatments for nausea and vomiting in pregnancy. According to the ACOG     recommendations, promethazine is the first line of parenteral treatment after oral treatment     had failed. Thiamine is given to prevent wernicke encephalopathy. This research try to find     out whether thiamine helps the vomiting and nausea as well, by comparing the response to     thiamine and promethazine in women who suffer from nausea and vomiting in pregnancy.   "
229910|NCT00861536|"     An open, multicenter, randomised, parallel group pilot study to investigate two different     polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of     ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients     following renal transplantation. This non-inferiority trial shall demonstrate that     ATG-Fresenius S is as efficacious as Thymoglobulin but has a better tolerance and fewer side     effects.   "
229911|NCT00861549|"     The purpose of this study is to evaluate the bioavailability of two formulations (Taiwan and     China mainland) of phencynonate hydrochloride tablets and to generate pharmacokinetic and     safety profiles of phencynonate hydrochloride in healthy volunteers.   "
229912|NCT00861562|"     The purpose of this study was to assess the clinical efficacy and safety of the drug Imescard     water smartweed compound pills in the treatment of patients with chronic constipation and     hemorrhoidal disease.   "
229913|NCT00861575|"     This is a continuous blood banking study that will archive plasma and blood permitting DNA     and plasma analysis at a future date. Subjects are recruited at the time of a clinically     required procedure and blood samples are collected and banked and used for future research.     The main purpose of this study is to investigate the interaction of multiple phenotypes and     genotypes and their impact on cardiovascular disease events and measures of atherosclerosis     progression.   "
229925|NCT00861731|"     The purpose of this study is to determine whether, in patients with chronic proteinuric     nephropathy and dyslipidemia, ezetimibe-simvastatin combined therapy is more effective than     statin alone to achieve the optimum lipid control, and if this translates to an improvement     of the markers of vascular damage. Thirty hypertensive patients in stable therapy with RAS     inhibitors, with low-density lipoprotein (LDL) cholesterol superior to 100 mg/ml, are treated     with three different hypolipidemic regimens: Simvastatin alone (40 mg/day) or     ezetimibe/simvastatin combined therapy (10/20 or 10/40 mg/day).   "
229914|NCT00861588|"     Benign prostatic hyperplasia (BPH) is a common problem among aging Caucasian men that     produces significant morbidity and hea1th care costs. It is likely that BPH is just as common     among Chinese men. Debate exists as to whether currently available surgical and     pharmacological options for BPH are appropriate for men in the watchful-waiting stage of this     condition. Evidence suggests that the consumption of soy isoflavones is related to lower     rates of BPH among Asian men. The advantages of soy isoflavones over conventional therapies     may include better patient compliance, improved safety and lower cost. Despite the fact that     soy isoflavones are safe and contain a health-conferring ingredient with a defined mechanism     of action, no randomised control trial has been performed using isoflavones to treat BPH.     Therefore, a randomised control trial is proposed to test the tolerability and effectiveness     of soy isoflavones (Soylife) verses placebo in 182 men with defined watchful waiting BPH over     a period of 12 months. In this trial, patients who fulfill the inclusion criteria, will     either be given 40mg of soy isoflavones capsule (once daily) or a placebo capsule. They will     be reviewed every three months with maximal urine flow rate, international prostate symptoms     score and quality of life measured. Baseline tests include RFT, LFT, FBC, MSU, PSA and     testosterone and to be repeated at 6th month and 12th month. The investigators hypothesize     that this intervention will reduce lower urinary tract symptoms and slow the progression of     the disease.   "
229915|NCT00861601|"     This is an open label, multi-centre, dose ranging study to assess efficacy, safety and     pharmacokinetics of eltrombopag in thrombocytopenic subjects with chronic liver disease.   "
229916|NCT00861614|"     The purpose of the study is to determine if advanced prostate cancer patients that are     treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone   "
229917|NCT00861627|"     The purpose of this Phase 2 study is to investigate whether intravenous administration of a     wild type reovirus (REOLYSIN®) in combination with paclitaxel and carboplatin is effective     and safe in the treatment of Non-Small Cell Lung Cancer with KRAS or EGFR activation.   "
229970|NCT00864747|"     The purpose of this study is to compare the relative bioavailability of Propranolol     Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg     Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult     volunteers under non-fasting conditions.   "
230107|NCT00866580|"     This observer-blind study is designed to evaluate the immune response and safety of pandemic     influenza vaccine in the elderly population.   "
229918|NCT00861640|"     Introduction: Proton pump inhibitor (PPI) is the drug of choice used in patients with     non-variceal upper gastrointestinal tract bleeding (UGIB). Intravenous (IV) PPI is more     commonly used than oral form when overt bleeding occurs. Previous study has revealed that     oral rabeprazole and IV omeprazole achieved similar intragastric pH elevation. It's probable     that oral form and IV PPI provide equal efficacy in treating mild to moderate UGIB patients.      Aim: This study aims to compare the effect of three-day oral rabeprazole and iv omeprazole on     bleeding control in patients with mild to moderate non-variceal UGIB.      Patients and methods: All patients presented with black to tarry stool passage or hematemesis     and visited our ER will be evaluated to recruit into this study. They will receive regular     vital sign monitoring, laboratory study and nasogastric tube insertion with gastric fluid     aspiration. Esophagogastroendoscopy and hemostatic procedure if need will be performed within     12 hours. Those confirmed to have non-variceal UGIB, stable vital signs and agree to     participate into this study will be randomized into two groups receiving either oral     rabeprazole (20mg bid) or iv omeprazole (40mg qd) for three days. The presence of recurrent     bleeding within three days, in-hospital complication and duration of hospital stay will be     recorded and analyzed.      Expected results: At the end of this study, we will be able to determine whether patients     treated with oral rabeprazole and iv omeprazole have similar re-bleeding or complication     rates and hospitalization days.   "
229919|NCT00861653|"     The purpose of this study is to utilize high-resolution CMR carotid imaging for the     characterization of carotid wall volumes and plaque content in patients with clinical     significant carotid atherosclerosis. Patients who are scheduled to undergo an imaging     procedure will be recruited from the cath lab. Upon enrollment, blood samples conventional     and genetic profiling will be collected. For patients undergoing a carotid endarterectomy,     tissue from the carotid vessel will be collected during their procedure. Comparison of the MR     images with tissue and/or blood samples will be made. Length of time in the study will be     approximately 1 day. There will be no study-related patient follow-up.   "
229920|NCT00861666|"     The purpose of this study is to evaluate a forgiveness-based writing intervention in an open     trial with 20 Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) veterans who have     recently experienced combat-related trauma to:        1. Determine the feasibility of delivering the intervention.        2. Evaluate the acceptability of the intervention.        3. Collect preliminary outcome data on PTSD symptoms, depression, anxiety, anger, and          forgiveness.   "
229921|NCT00861679|"     To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the     HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched     family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether     therapy has been carried out according to the main HSCT protocol recommendations. The     standardisation of the treatment options during HSCT from different donor types aims at the     achievement of an optimal comparison of survival after HSCT with survival after chemotherapy     only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after     HSCT from MSD, from MD and from MMD.   "
229922|NCT00861692|"     The purpose of this study is to collect data on the clinical management of Argatroban in     patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or     without ongoing thrombosis who require parenteral antithrombotic therapy   "
229923|NCT00861705|"     This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or     bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with     breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel,     carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may     stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy     together with bevacizumab before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed.   "
229924|NCT00861718|"     Multiple Ascending Dose Study   "
229926|NCT00861744|"     The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines     (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and     safety with a six month follow-up after first vaccination. Additionally, antibody persistence     will be assessed one and two years after administration of MMR vaccine.      The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.   "
229929|NCT00861783|"     Studies done in the laboratory have demonstrated beneficial effects of ON 01910.Na, a new,     unapproved drug, when it is used in combination either irinotecan and oxaliplatin, two     approved, extensively used anti-cancer drugs. In these laboratory studies, mice implanted     with cells (Bel-7402 cells) that came from a human tumor were used as a model of liver     cancer. In mice that were not treated, the Bel-7402 cells formed very large tumors. In mice     that were treated with ON 01910.Na, irinotecan or oxaliplatin alone, growth of tumors was     reduced compared to the untreated group. When a combination of ON 01910.Na and irinotecan or     of ON 01910.Na and oxaliplatin was used to treat the mice, tumor growth was completely     inhibited. Another observation in these studies was that toxicity did not increase when the     combinations were used. These results and similar results from other studies support the     hypothesis that a combination of ON 01910.Na and irinotecan or of ON 01910.Na and oxaliplatin     would be an effective and tolerable treatment for liver and other types of cancer.      The primary objective of this phase 1 study is to find out what doses of ON 01910.Na in     combination with either irinotecan or oxaliplatin are safe and tolerable in patients with     liver and other types of cancer.   "
229930|NCT00861796|"     This Phase II study will test whether CYR-101, a CNS-active compound with novel     pharmacological profile and devoid of dopamine D2 receptor binding properties, is efficacious     when administered orally in the management of patients with a diagnosis of DSM-IV     schizophrenia.   "
229931|NCT00861809|"     The purpose of this study is to assess the pharmacodynamic effects (gastric emptying),     safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type 1 diabetic     patients with gastroparesis.   "
229971|NCT00864760|"     The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin     Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by     Parke-Davis under fasting conditions.   "
229932|NCT00861822|"     One of the major complications of heart surgery is kidney injury, which occurs in up to 30%     of patients and is associated with poor outcomes including death. We have found that patients     whose hemoglobin concentration before surgery is lower than normal (i.e., are anemic) are at     particularly high risk for this complication, likely because their hemoglobin concentration     drops to very low levels during surgery, which reduces delivery of oxygen to the kidneys,     increases blood loss, and necessitates blood transfusions. We and others have shown that     these events are individually harmful to the kidneys, and can lead to kidney injury. We     believe that we can prevent these events from occurring, and as a result reduce the risk of     kidney injury, if we transfuse anemic patients at least 1 day before surgery rather than     during surgery.      In anemic patients undergoing cardiac surgery, prophylactic transfusion of red blood cells     (RBCs) before surgery will reduce the risk of acute kidney injury (AKI) after surgery by     mitigating three inter-related risk factors for AKI.   "
229933|NCT00861835|"     Purpose: Previous studies suggested an increased diagnostic yield for bronchoscopic (FB)     transbronchial needle aspirate (TBNA) specimens from mediastinal lymph nodes when using rapid     on-site evaluation by cytopathology (ROSE) but were limited by lack of randomization. The     investigators performed the first randomized-prospective trial comparing ROSE(R) to no     on-site cytopathology assessment (NR).      Methods: All patients referred were eligible. 78 patients were randomized to R or NR groups.     For R procedures, further specimens were deferred until results were available from the     on-site cytopathologist. Diagnoses made by all procedures were recorded. The primary     end-points were specimen adequacy and diagnostic yield.   "
229934|NCT00861848|"     The present study is designed to:        1. investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in          adolescents and adults ages 13-40 with congenital and acquired congenital heart disease        2. compare RT-MCE with dobutamine stress perfusion MR for determination of coronary flow          reserve and ventricular wall motion        3. assess regional myocardial mechanics using myocardial speckle tracking and MR tagging.   "
229935|NCT00861861|"     The purpose of this study is to compare the effects of pitavastatin and atorvastatin on     adiponectin percentage change in patients with hypercholesteremia comorbid stable CAD.   "
229936|NCT00856102|"     The objective of the proposed research is to determine the efficacy of a home-based walking     exercise program in promoting cognitive-psychosocial functions of men with prostate cancer     receiving androgen depletion therapy (ADT). ADT is the mainstay treatment for men with     advanced prostate cancer. However, ADT has a number of side effects including compromised     cognitive function, depression and anxiety, which negatively impacts the quality of life of     men with prostate cancer. The central question of the proposed research is to determine if     exercise will have a positive impact on the quality of life of men with prostate cancer     undergoing ADT.      Hypothesis:   "
229937|NCT00856115|"     RATIONALE: Gathering information about timely diagnosis in African American and Caucasian     patients with newly diagnosed colorectal cancer may help doctors learn more about factors     that influence a diagnosis and plan the best treatment.      PURPOSE: This phase I trial is studying differences in timely cancer diagnosis in African     American patients and in Caucasian patients with newly diagnosed colorectal cancer.   "
229938|NCT00856141|"     In this modern era, surgeons prefer to perform emulsification through small micro incisions.     To accomplish this safely, surgeons raise irrigation bottle heights or use forced infusion     systems.We believe that this sustained rise in the IOP during micro-incision     phacoemulsification for a substantial period could be detrimental to the ocular structures.     Therefore, intra-operative IOP pertaining to micro-incision cataract surgery is an emerging     concern.      Conventional systems for measuring IOP generate an isolated graph of continuous pressure     recording. Interpretation of the IOP fluctuations from these graphs requires a two step     superimposition approach to characterize the IOP changes.   "
229939|NCT00856154|"     Phase I test of concept study: In an attempt to induce new immunity to HIV-1 during untreated     HIV-1 infection the investigators have identified relatively immune silent immune subdominant     HLA-A2-restricted HIV-1 CTL epitopes that fit individuals with the HLA-A2 tissue type (about     50% of peoples in Denmark). Immunising with these conserved epitopes could induce new     immunity and lower viral load so the patient will live longer before AIDS or Antiviral     medicine and a lower viral load will limit spread in the population. As adjuvants the     investigators used patients' own autologous Dendritic Cells generated from blood cells in     vitro. 12 healthy male HIV-1 infected not in therapy individuals were used for this     therapeutic vaccination and tested for safety and induction of new cellular CD8 and CD4     T-cell immunity.   "
251696|NCT01149811|"     The purpose of this clinical trial is to compare the safety and tolerability of two dose     regimens of fipamezole in adult patients with Parkinson's Disease who are receiving levodopa.   "
229940|NCT00856167|"     This study seeks to evaluate the benefits of different combinations of a Self Care program,     involving individually targeted education and support, plus Traditional Chinese Medicine, in     terms of patients' experience and outcomes in short-term follow-up (8 weeks) and long-term     follow-up (18-months). The study seeks to evaluate the benefits and drawbacks of different     patterns of stepped care, which means different levels of care depending on patients'     responses at various time-points in the study, which might be used by clinicians treating in     the future.   "
229941|NCT00856180|"     The goals of this study were to evaluate the efficacy and safety of sequentially blocking the     angiogenesis pathway via known antiangiogenic mechanisms, first with bevacizumab and then     addition of oral cyclophosphamide upon progression of cancer through bevacizumab. The drugs     used in this study were chosen because of their known antiangiogenic properties,     tolerability, and anti-ovarian cancer effects.   "
229942|NCT00861874|"     The purpose of this study is to determine the safety and feasibility of the combination of     decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed     or refractory acute myeloid leukemia.   "
229986|NCT00864955|"     The DIMUVA study aims to evaluate the correlation between cutaneous phototype and the nature     and quantity of damage caused to cutaneous DNA after exposure to UV-A radiation.   "
229987|NCT00864968|"     The purpose of this study is to evaluate the relative bioavailability of nabumetone from 2     tablet products and determine if the 2 products were bioequivalent to each other.   "
229943|NCT00861887|"     BACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel,     usually associated with previous use of antibiotics. The disease course may be complicated by     fulminant disease requiring removal of the colon or by multiple recurrences requiring     re-hospitalization. The incidence and severity of Clostridium difficile infection is rising,     and it poses an increasing burden on the health system. For example, in one of our previous     studies we found that 804 in-patients and 568 out-patients had a positive test for     Clostridium difficile toxin at Beaumont Laboratories in 2003. The standard treatment is a 2     week course of Vancomycin or Metronidazole. The clinical response to Metronidazole appears to     be declining, and many practicing clinicians prefer Vancomycin as a first-line treatment. The     recurrence rate after the treatment is similar for Vancomycin and Metronidazole and is     usually in the range of 15-25%, although recent reports noted a recurrence rate up to 50%     during outbreaks with a virulent strain. Recently, it has been suggested that a 2 week     duration of treatment might not be adequate in clearing the infection.      Our HYPOTHESIS is that a prolongation of Vancomycin treatment from 2 weeks to 4 weeks will     lead to a decrease rate of recurrent Clostridium Difficile colitis.   "
229944|NCT00861900|"     The investigators have obtained compelling evidence that the development of anti-human     leukocyte antigen (anti-HLA) antibodies against mismatched donor antigens significantly     correlates with the development of bronchiolitis obliterans (BOS). Further, these anti-HLA     antibodies are developed at least 15 months prior to any clinical evidence of BOS. This lag     period between the development of anti-HLA antibodies and the onset of BOS gives us an     opportunity to intervene to delay and/or prevent the development of BOS.   "
229945|NCT00861913|"     This phase II trial is studying the side effects of pazopanib hydrochloride and to see how     well it works in treating patients with metastatic melanoma that cannot be removed by     surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.   "
229946|NCT00861926|"     Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study   "
229947|NCT00861939|"     The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 300     mg ER Tablets under fasting conditions.   "
229948|NCT00861952|"     The purpose of this study is to determine if the use of Neuragen (a natural health product     oil rubbed into the skin) is effective at reducing pain and improving the quality of life in     people with diabetic peripheral neuropathy.   "
229949|NCT00861965|"     This phase I/II clinical investigation is designed to determine the safety and anti-tumor     effects of intravenous administration of the experimental immunotherapy drug, called     AlloStim. The active ingredient of AlloStim is living, human immune cells that have been     differentiated and expanded outside the body. Because AlloStim does not require HLA match, it     is being evaluated as an alternative to allogeneic bone marrow/stem cell transplantation.   "
229950|NCT00861978|"     The aim of tis study is to assess the efficacy and safety of Jarsin® 300 mg as an acute     treatment in mild to moderate depression with atypical features.   "
229951|NCT00861991|"     Background: Empathy is critical to clinician-patient communication and patient outcomes.     Perspective-taking, an intervention demonstrated in other contexts to induce empathy, has     never been studied in a medical context. As a first step in evaluating its potential clinical     value, the studies described below assess perspective taking in a series of clinical skills     examinations. These examinations are simulated clinical encounters: students encounter and     are evaluated by standardized patients (SPs)--actors trained to take on patient roles. Though     not real clinical encounters, clinical skills examinations have been demonstrated to test     clinical competency well enough to be incorporated into the licensure examination of the     National Board of Medical Examiners.      Objective: To assess if perspective-taking improves the satisfaction of standardized patients     in three clinical skills examinations.      Hypothesis: Students receiving a perspective taking intervention will receive better     standardized patient satisfaction scores than control students.      Design and Setting: Three randomized, controlled studies. Studies 1 and 3: Junior medical     students(N = 503), 6-station clinical skills examination. Study 2: physician assistant     students (N = 105), 3-station clinical skills examination.      Intervention: The intervention students received a perspective-taking instruction prior to     their examination asking them to put themselves in their patients shoes and to imagine what     they were thinking and feeling. The control students received standard pre-examination     instructions. Simulated patients were blind to study condition. Main Outcome Measure:     Simulated patient satisfaction scores.   "
229952|NCT00862004|"     The purpose of this study is to examine the feasibility of video-assisted thoracoscopic     surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical     stage IIIA non-small cell lung cancer. Success is defined as VATS major pulmonary resection     with SND without conversion. If success rate over 90%, VATS major pulmonary resection with     SND is considered as feasible procedures for clinical stage IIIA non-small cell lung cancer.   "
229953|NCT00862017|"     There are receptors to free glutamate in the oral cavity and stomach that may mediate effects     of this amino acid on gastrointestinal physiology. The investigators hypothesize that a     chronic supplementation of monosodium glutamate (MSG) could modulate gastric emptying and the     further metabolism of dietary protein in healthy subjects.   "
229954|NCT00862030|"     Radiotherapy (RT) treatment to the chest is a standard way of trying to decrease symptoms     like cough or shortness of breath. Before any RT can be delivered, it must be planned, either     using conventional x-rays (fluoroscopy) or using computer tomography (CT) scanning. This     study is being done because the investigators do not know which of these two common ways of     RT planning is better for balancing both treating the cancer and decreasing side effects.   "
229955|NCT00862043|"     The purpose of this study is to evaluate the clinical efficacy of the mid-term treatment with     sildenafil in patients with persistent moderate or severe pulmonary hypertension (PH) after a     heart valve intervention.   "
229956|NCT00862056|"     This study will evaluate the use of cardiac CT in identifying atherosclerosis plaque in     patients who have not been diagnosed with atherosclerosis and who have no symptoms of the     disease but who are at risk of developing atherosclerosis based on traditional risk factors     such as diabetes or a family history of coronary artery disease.   "
229957|NCT00862082|"     The current understanding of PR104 justifies the evaluation of PR104 with sorafenib in     patients with hepatocellular carcinoma. These include:        -  Hypoxia. Hepatocellular Carcinoma (HCC) is likely to demonstrate a level of hypoxia          sufficient to activate PR104 to its active metabolites PR104H and PR104M. In addition,          in preclinical models, sorafenib has been demonstrated to increase the degree of hypoxia          in tumors following treatment.        -  Non-overlapping toxicity. PR104 and sorafenib do not share major toxicities. It is          anticipated that both drugs can be administered at their full single agent dose when          used in combination.        -  Aldo-keto reductase 1C3 (AKR1C3). HCC has been shown to express high levels of AKR1C3          which should lead to selective activation of PR104 within both hypoxic and oxic HCC          cells.        -  Preclinical data. The use of sorafenib and PR104 alone and in combination in a          hepatocellular carcinoma model demonstrates activity of PR104 as a single agent and          increased activity when PR104 and sorafenib are used in combination.      The current study will provide an estimate of the activity of PR104 in subjects with HCC.     This information will prove valuable in defining the future clinical development of PR104,     and in determining if PR104 has sufficient activity in HCC to warrant a larger phase III     registration study in this indication.      Primary objectives        -  Phase I: Determine the maximum tolerated dose (MTD) of PR104 when used in combination          with standard dose sorafenib        -  Phase II: Estimate the response rate (RR) of PR104/sorafenib [Note: Phase II was never          initiated]      Secondary objectives        -  Evaluate survival        -  Evaluate Progression Free Survival (PFS)        -  Evaluate time to progression (TTP)        -  Evaluate safety        -  Evaluate the pharmacokinetics (PK) of sorafenib, PR104 and PR104 metabolites        -  Collect diagnostic biopsy samples for the determination of aldo-keto reductase 1C3        -  Collect plasma samples for assessment of potential biomarkers of tumor hypoxia   "
229958|NCT00862095|"     To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in     patients with chronic post-traumatic headaches.   "
229959|NCT00862108|"     The purpose of this study is to determine whether norepinephrine gene polymorphism affect to     treatment response in ADHD   "
229960|NCT00862121|"     The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose     and a 4 g evening dose is efficacious in active mild to moderate CD.   "
229961|NCT00862134|"     The current understanding of PR104 justifies the evaluation of PR104 with docetaxel in     subjects with Non Small Cell Lung Cancer (NSCLC). These include:        -  Aldo-keto reductase 1C3 (AKR1C3). NSCLC has been shown to express high levels of AKR1C3          in about one half of tumors tested. Subjects with high levels of AKR1C3 should have          increased activation of PR104 within their tumor.        -  Hypoxia. NSCLC has been demonstrated to be a tumor with hypoxia based on both direct          tumor measurements (oxygen electrodes) and hypoxic positron emission tomography (PET)          imaging. Tumor hypoxia in NSCLC should be sufficient to activate PR104 to its active          metabolites PR104H and PR104M.        -  Preclinical data. The use of docetaxel and PR104 alone and in combination in preclinical          models demonstrates activity of PR104 as a single agent and supraadditive activity when          PR104 and docetaxel are used in combination.        -  Manageable toxicity. PR104 and docetaxel with Granulocyte Colony-stimulating Factor          (G-CSF) have been combined in a prior phase I study. A Maximum Tolerated Dose (MTD) has          been identified and the major toxicities of this combination are understood.      The current study will provide an estimate of the activity of PR104 in subjects with NSCLC.     This information will prove valuable in defining the future clinical development of PR104,     and in determining if PR104 has sufficient activity in NSCLC to warrant a larger phase III     registration study in this indication.      Primary objectives      • Estimate the response rate (RR) of PR104/docetaxel      Secondary objectives        -  Evaluate survival        -  Evaluate progression free survival (PFS)        -  Evaluate time to progression (TTP)        -  Evaluate safety        -  Evaluate the pharmacokinetics of PR104 and its metabolites        -  Evaluate the pharmacokinetics of docetaxel        -  Evaluate the tumor hypoxia using 18F-fluoromisonidazole (18F-MISO) PET imaging        -  Collect diagnostic biopsy samples for the determination of AKR1C3        -  Collect plasma samples for assessment of potential biomarkers of tumor hypoxia   "
229962|NCT00862147|"     The objective of this study is to evaluate the effect of the International Child Development     Program (ICDP). Research questions to be answered:        1. Does the ICDP affect children's psychosocial functioning compared to treatment as usual?        2. Does the ICDP change parent-child interaction?   "
229963|NCT00862160|"     The prospective, randomized, two centre study investigates acute cerebrovascular events     during extracorporal circulation and the early post operative outcome when using either the     minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass     circuit in patients undergoing coronary artery bypass grafting.   "
229964|NCT00862173|"     Non small-cell lung cancer (NSCLC) accounts 85% of all lung cancer.The development of brain     metastasis diminished life expectancy to less than one year with a median survival of less     than three months. In NSCLC cancer, approximately 50% of patients with locally advanced     disease develop brain metastasis at some time during the natural of disease. The central     nervous system constitutes the first site of recurrence in 15 to 40% of these patients.     Microarrays evaluate the diagnosis, treatment and prognosis of lung cancer.There are no     studies that specifically evaluate the relationship between a genetic profile of NSCLC and     metastasis to the CNS, with the purpose of distinguishing a subgroup of patients that will     benefit of prophylactic treatment.What is the association between a genetic profile on NSCLC     and the development of CNS metastasis.Obtaining a genetic profile from the primary NSCLC     tumor cells, by using microarrays, we can predict the development of CNS metastasis arise a     subgroup of patients that could benefit from prophylactic cranial radiation with which their     quality of life and prognosis most probably will increase.Objective:Determine the association     between a genetic profile from the primary tumor cells and the development of central nervous     system metastasis in patients with non small-cell lung cancer.A genetic profile from the     primary tumor cells are associated with the development of central nervous system metastasis     in patients with NSCLC. A clinical, prospective, analytic, open, non randomized, prognostic     and observational cohort with 66 patients with NSCLC who authorize a biopsy study from     February, 2008 to December, 2012, INMEGEN institute will be in charge of performing the     microarrays and the computer analysis in order to obtain the different genetic profiles that     will be differentially expressed related with CNS metastasis risk profiles. Patients will be     followed-up by means of the external consult of lung neoplasms. The statistical analysis will     be performed using tests like Student's t or Mann-Whitney's U test. A multivariate analysis     of logistic regression will be performed. Global survival time will be analyzed using     Kaplan-Meier's technique and the comparison between groups will be performed with log-rank     test. The adjustment for potential confusors will be performed using multivariate regression     analysis. For result representation, we will use tables and graphs and pertinent measures     will be taken to disclose the study.   "
229965|NCT00862186|"     This study will investigate self-management of cancer-related fatigue by adolescents through     pilot study of an evidence based educational resource.   "
229966|NCT00862212|"     The purpose of this study is to treat individuals with social anxiety disorder with a Food     and Drug Administration-approved medication for the treatment of social anxiety disorder, the     antidepressant paroxetine, and to evaluate the impact of an intervention designed to help     those individuals cope with anxiety without the use of common coping behaviors.   "
230074|NCT00866138|"     This phase 2 study was designed to assess the safety and efficacy of masitinib (AB1010) in     patients with relapsing/refractory t(4;14) Multiple Myeloma. Response and progression were     assessed according to the Bladé revised IMWG criteria1 from lowest point.   "
229967|NCT00862225|"     Randomised, double-blind and prospective clinical study to examine the mechanism of action of     the Petasites hybridus leaf extract IG-RD-001 (Ze-339, petasol butenoate complex) compared to     desloratadine and placebo in patients with seasonal allergic rhinitis of all degrees of     severity (provoked by grasses). The treatment arm with desloratadine is an established     standard treatment and is intended to ensure the comparative methodology of the study.   "
229968|NCT00864721|"     The purpose of this research study is to find out what effects (good and bad) sunitinib has     on patients and their NSCLC.   "
229969|NCT00864734|"     The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg     Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co. with that of 5 mg/500 mg     CLUCOVANCE® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5     mg/500 mg tablet) in healthy adult volunteers under non-fasting conditions.   "
229988|NCT00864981|"     The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 150     mg SR Tablets under fasting conditions.   "
229972|NCT00864773|"     The pathophysiology of central serous chorioretinopathy remains controversial. traditional     treatment is laser photocoagulation or photodynamic therapy.Recently Bevacizumab (Avastin,     Genetech),an antibody to vascular endothelial growth factor (VEGF),has known antipermeability     properties and therefore may theoretically reverse the changes seen in central serous     chorioretinopathy. The aim of this study is To investigate concentrations of growth factors     and inflammatory cytokines and to report the effect of therapy with bevacizumab in eyes with     central serous chorioretinopathy   "
229973|NCT00864786|"     Multiple dose safety and pharmacokinetics in healthy male subjects   "
229974|NCT00864799|"     Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead,     severely malformed or in cases of maternal illness. This process is usually conducted     medically in Australia, using the synthetic prostaglandin E1 analogue misoprostol. This     prostaglandin, although not licensed for use in pregnancy termination, is now a common     abortifacient with a large accumulated experience both within Australia and internationally.     Since 1996, misoprostol has been used at King Edward Memorial Hospital as the principal agent     for second trimester pregnancy termination.      Misoprostol may be administered vaginally, orally, sublingually or buccally in the process of     pregnancy termination. Each route of administration has its own advantages and disadvantages.     The most appropriate route of administration, with the shortest duration of abortion and     lowest side-effect profile has not been determined for all circumstances.      The combination of mifepristone and misoprostol is an established and effective method for     second trimester pregnancy termination. Prior studies have demonstrated a significant     reduction in the duration of abortion with misoprostol when mifepristone priming is used. In     November 2007, the TGA (Therapeutic Goods Administration) approved an application by the     Principal Investigator of this planned study for Authorised Prescriber status for use of the     antiprogesterone agent mifepristone. Since January 2008 the combination of mifepristone and     misoprostol has been used at KEMH for first and second trimester pregnancy termination of     pregnancy, predominantly for circumstances of severe fetal abnormality.      There is however limited data on the impact of gestation on the duration of second trimester     termination. Almost all published studies to date have recruited women in the early second     trimester (typically with a median of 16 weeks gestation). However, most terminations of     pregnancy for fetal abnormality (the most frequent reason for pregnancy interruption of a     live fetus at KEMH) occur at 18-24 weeks gestation. The investigators' experience indicates a     significant impact of increasing gestation with prolongation of the duration of pregnancy     termination. In this study the investigators aim to evaluate three misoprostol regimens for     second trimester pregnancy termination following mifepristone priming with the primary     intention to develop a protocol which results in a delivery rate within 24 hours for 95% of     women at gestations <24 weeks.      Secondary aims of this study will be to assess the incidence of maternal side-effects for     each of the three regimens, the placental retention rates and the need for curettage for     retained placental tissue. As the investigators will be using 3 different methods of     misoprostol administration, the investigators will also review women's satisfaction with the     three regimens for pregnancy termination.   "
229975|NCT00864812|"     Study title        -  A randomized, open label, multicenter, phase 4 study for the comparison of efficacy of          tiotropium plus salmeterol/ fluticasone propionate compared with tiotropium alone in          COPD patients      Study objectives        -  To investigate clinical outcomes of combining tiotropium with fluticasone          propionate/salmeterol (FSC) 250/50μg bid compared with tiotropium alone in patients with          moderate or severe COPD in Korea      Study Design        -  Randomized, open-label, multicenter, parallel-group, two group study      Study assessment        -  FEV1        -  Inspiratory capacity (IC)        -  History of COPD exacerbation        -  History of hospitalization for COPD exacerbation and all causes        -  QoL (SGRQ-C)   "
229976|NCT00864825|"     The objective of the study is to evaluate the efficacy of allopurinol, compared to placebo,     as add-on to anti-psychotics in the treatment of patients with schizophrenia.   "
229977|NCT00864838|"     The purpose of this study is to evaluate the effects of anterior chamber paracentesis,     brimonidine and oral acetazolamide to reduce intra-ocular pressure variations after     intravitreal bevacizumab injection.   "
229978|NCT00864851|"     The purpose of this study is to compare the safety and effectiveness of various doses of     Replagal in patients with cardiomyopathy due to Fabry disease.   "
229979|NCT00864864|"     The purpose of this research study is to determine if sunitinib can get past the blood-brain     barrier and into the brain tumor. Sunitinib has shown promising results in treating other     cancers and works by blocking blood flow to tumors, which may prevent them from growing     further. At the present time, there is no chemotherapy that can cure glioblastoma. The reason     why chemotherapy is not fully effective is that many drugs cannot penetrate into brain     tumors. This is due to the presence of the blood-brain barrier (BBB) which normally protects     the brain from substances in the blood.   "
229980|NCT00864877|"     A randomised, prospective clinical investigation to compare post-operative fracture healing     and complication rate after the fixation of ankle fractures using the Inion OTPS     FreedomPlateTM Biodegradable Fixation System versus conventional stainless steel metal screws     and plates.      The objectives of the investigation are        -  to compare post-operative fracture healing (union rates, time-to-union), and the          complication rates (hardware failure, infection) between the two Plating Systems          (biodegradable INION OTPS FreedomPlateTM vs. Stainless Steel 3.5 Reconstruction or DCP          plate, or 1/3 Semitubular plates) at the clinical setting of Ankle fractures        -  to study the safety of the clinical application of the biodegradable plating system of          Inion OTPS FreedomPlateTM at the acute Ankle fracture setting.   "
229981|NCT00864890|"     The purpose of this study is to evaluate and compare the relative bioavailability, and     therefore the bioequivalence of two formulations of Citalopram after a single dose     administration under fed conditions.   "
229983|NCT00864916|"     People infected with HIV have a greater risk of developing cardiovascular disease than people     not infected with HIV. This may be due to increased inflammation in the blood vessels. This     study will determine whether an anti-inflammatory drug, pentoxifylline, in combination with     antiretroviral medications, is more effective at improving blood vessel function and reducing     inflammation than antiretroviral medications alone in people infected with HIV.   "
229984|NCT00864929|"     The present study is a retrospective cohort study on patients who suffered a nosocomial     infection in major hospitals in Vietnam. Data relating to patient demography include age,     gender; medical history; APACHE II score; background conditions, infection details and     antimicrobial therapy; and all-caused mortality, time of hospitalization and intensive care.     The investigators hypothesis is that antimicrobial treatment inappropriate is highly     dependent on incidence of antibiotic resistant pathogens, nonfermentative Gram-negative     bacilli and ESBL-producing enterobacteriaceae spp. Variables are demographic characteristics,     background conditions, immunosuppressive therapy, antimicrobial susceptibility and     inappropriate treatment is explored as possible predictors of mortality.   "
229985|NCT00864942|"     This study is for subjects with a B-cell lymphoid malignancy (lymphoma) or chronic     lymphocytic leukemia (CLL) that has come back after or did not get better with previous     treatment. The purpose of this study is to find out the highest dose of lenalidomide that can     be given together with bendamustine and rituximab. The study will also look what effects the     combination of lenalidomide and bendamustine and the combination of lenalidomide,     bendamustine and rituximab will have on patients and their disease.   "
229989|NCT00864994|"     There is increasing evidence in the literature that COPD should not be considered as a     localised pulmonary disorder but as a systemic disease involving pathology in several extra     pulmonary tissues. Well characterized systemic features are a chronic low grade systemic     inflammation, altered body composition and a skeletal muscle fibre type shift. There are     indications that an absolute or relative increase of fat mass puts COPD patients at increased     risk for cardiovascular pathology while muscle atrophy is associated with a high prevalence     of osteoporosis and with impaired physical function. The origin of systemic inflammation is     poorly understood. Both endogenous and exogenous risk factors contribute to systemic     inflammation and extra-pulmonary manifestations of COPD.      Overall objective of study 3:      To compare the pattern and severity of the systemic inflammatory profile in relation to     skeletal muscle weakness and cardiovascular risk profile in COPD patients with mild to     moderate disease compared to non-susceptible smokers.      Specific objectives:        1. To study the relative contribution of pulmonary and extra pulmonary factors on exercise          capacity, skeletal muscle function and health status        2. To relate diet, physical activity and cardiovascular risk factors to body composition,          skeletal muscle function and exercise capacity status        3. To study the influence of the emphysema phenotype on extra pulmonary pathology in COPD        4. To study muscle fibre type size and composition and to relate muscle oxidative phenotype          with insulin sensitivity, inflammation (local and systemic) and molecular signatures of          oxidative energy and protein metabolism.      Study design:      Cross-sectional study. Healthy smoking subjects and COPD patients will undergo extensive     clinical, metabolic and inflammatory assessment at the university clinics in Groningen,     Maastricht and CIRO Horn.      Study population:      Totally 60 subjects will be included        -  30 healthy subjects who after 20 pack years smoking have no signs of COPD (age 40-75          years)        -  30 COPD patients with GOLD stage II (age 40-75 years)   "
229990|NCT00865007|"     The aim of this study is to evaluate the efficacy for the recovery of peripheral fat of     lopinavir/ritonavir in monotherapy versus abacavir/lamivudine and lopinavir/ritonavir in     subjects who developed lipoatrophy while receiving zidovudine plus lamivudine plus abacavir.   "
229991|NCT00865020|"     This study was specifically designed to provide additional information on the mechanism of     action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The     purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that     of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood     Pressure Monitoring setting after a one week treatment withdrawal.   "
229992|NCT00865033|"     The purpose of this study is to demonstrate the relative bioequivalence of Metformin HCL     Tablets, 1000 mg under fasting conditions.   "
229993|NCT00865046|"     185 veterans with chronic knee pain and advanced knee osteoarthritis will be recruited to     participate in this study designed to test the effectiveness of a special type of electrical     acupuncture called periosteal stimulation (PST). Participants will be divided into three     groups. They will receive PST or a control condition once a week for 10 weeks. Two-thirds of     the participants will receive booster sessions periodically over the course of the next 6     months. Everyone will be called monthly during the 6 month period and then will be asked to     return for an evaluation on site at the end of this period.   "
229994|NCT00865059|"     The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin     Tablets by Purepac Pharmaceutical Co. with that of 800 mg NEURONTIN® Tablets by Parke-Davis     following a single oral dose (1 x 800 mg) in healthy adult volunteers under non-fasting     conditions.   "
229995|NCT00865072|"     The purpose of this study is compare the relative bioavailability of 750 mg Metformin     Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co with that of 750 mg     GLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 750     mg) in healthy adult volunteers under fasting conditions   "
229996|NCT00865085|"     The purpose of this study is to evaluate and compare the relative bioavailability, and     therefore the bioequivalence of two formulations of Citalopram after a single dose     administration under fasting conditions.   "
229997|NCT00865098|"     This study is conducted in Japanese newly diagnosed locally advanced SCCHN patients in order     to assess tolerability and feasibility of Cetuximab plus concomitant boost radiotherapy (RT)     regimen (the study treatment) and its safety profile (i.e. AEs: adverse events). In addition,     efficacy (i.e. anti-tumor effect) of the study treatment is also evaluated.   "
229998|NCT00865111|"     The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion     150 mg sustained release tablet to that of Wellbutrin SR sustained release tablet after a     single, one-tablet dose in fasted subjects.   "
230076|NCT00866164|"     Intrathecal infusion pumps are increasingly used to deliver analgesics for chronic     intractable pain. The PUMP II trial is designed to evaluate the ongoing safety and efficacy     of the new Prometra® Programmable Pump System for intrathecal administration of morphine     sulfate to treat chronic intractable pain.   "
229999|NCT00865124|"     Aldosterone is a significant mediator of cardiovascular injury associated with heart failure     and the cardiovascular benefits of mineralocorticoid receptor blockade are additive to those     of angiotensin converting enzyme inhibitors or angiotensin II (ANGII) receptor blockers. This     study will test the hypothesis that mineralocorticoid receptor (MR) antagonists exert     beneficial cardiovascular effects, specifically by decreasing vascular injury and improving     vascular function. A randomized, double-blind study will be conducted, in which participants     with Type 2 Diabetes Mellitus will undergo a series of assessments to test heart, blood     vessel, and kidney function at baseline, and after 2 and 6 months of treatment with one of     the following drugs:        1. spironolactone        2. hydrochlorothiazide (HCTZ) plus potassium        3. placebo      In the event of insufficient funds, randomization to the placebo arm will be stopped and     primary assessment of outcomes will occur at baseline and after 6 months of treatment.   "
230000|NCT00865137|"     The purpose of this study is to evaluate the effect of food on the oral bioavailability of     tacrolimus modified release (MR4) capsules together with a standard continental breakfast.     The objective is to assess the pharmacokinetics and relative bioavailability with and without     food.   "
230001|NCT00865150|"     Primary Hypotheses of the study include:        -  Metabolic profiles are influenced by gestational age, chronological age, type and degree          of nutritional support and illness        -  Metabolic profiles differ between neonates who receive commercial formula and neonates          who receive primarily human breast milk        -  Neonates who develop parenteral associated cholestasis have metabolic markers that          identify at risk patients (high serum urea nitrogen, citrulline, histidine, methionine,          and succinyl carnitine and low thyroxine, serine and glutamate)        -  Neonates that have hypothyroidism have abnormal metabolic profiles (low tyrosine levels)   "
230002|NCT00865163|"     LASER is designed to gather data about ischemic an bleeding complications for a period of 12     months after a PCI with the aim to optimize the therapy of these patients.   "
230003|NCT00865176|"     The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg     ER Tablets under fasting conditions.   "
230005|NCT00865202|"     Post-operative delirium is a common and deleterious complication in elderly patients. The     investigators have previously found lower levels of serum tryptophan in post-operative     elderly patients who developed delirium in comparison to post-operative elderly patients who     did not develop delirium. The investigators hypothesize that post-operative supplementation     of L-tryptophan will reduce the duration and incidence of post-operative delirium. This study     is a double-blinded placebo controlled trial of L-tryptophan supplementation in     post-operative ICU patients 60 years and older. The primary outcome measure is the comparison     of duration of post-operative delirium in subjects who receive L-tryptophan supplementation     versus a similar appearing control.   "
230006|NCT00865215|"     The purpose of this study is TO compare the relative bioavailability of Propranolol     Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg     Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult     volunteers under fasting conditions.   "
230007|NCT00865228|"     The purpose of this study is to determine the role of time of dosing on the lipid-lowering     effects of lapaquistat acetate, once daily (QD) or twice daily (BID), in subjects with     hypercholesterolemia.   "
230008|NCT00865241|"     The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg     Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co. with that of 5 mg/500 mg     CLUCOVANCE® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5     mg/500 mg tablet) in healthy adult volunteers under fasting conditions.   "
230009|NCT00865254|"     Nicotine dependence is prevalent in society, cigarette smoking is associated with several     known health risks, and most dependent individuals find it very difficult to stop smoking     cigarettes. The present study will test the efficacy of a behavioral smoking cessation     treatment, prize-based contingency management, that has not undergone rigorous study with     respect to smoking, it but has demonstrated efficacy in reducing use of other substances     (e.g. cocaine). If efficacious, prize-based contingency management would add to our     repertoire of efficacious smoking cessation treatments.   "
230010|NCT00865267|"     The purpose of this study is to determine the duration of application of halobetasol     propionate 0.05% ointment to be used in a definitive study of bioequivalence of to     formulations of this ointment.      Part A: To validate vasoconstrictor assay precision.      Part B: To evaluate the dose response vasoconstriction profile of Ultravate® 0.05% ointment     at different dose durations over a short period of time (0.17 - 4 hrs).   "
230011|NCT00865280|"     A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of     complicated skin and skin structure infections (cSSSI).   "
230012|NCT00865293|"     The purpose of this study is to investigate posture dependent small airway obstruction in     subjects with obesity, and to study the capacity of FOT as a measurement tool for small     airways obstruction.   "
230013|NCT00865306|"     The aim of this study was to develop and pilot a cognitive-behavioral therapy (CBT)     parent-child intervention for 4-7-year-old children at risk for anxiety disorders. The     20-session intervention was first piloted openly in 9 children (between 3/10/98 and     1/1/2001). The intervention was then tested in 65 children in a randomized controlled trial     versus a monitoring-only wait-list control condition. Children had to either have an anxiety     disorder, behavioral inhibition, or be the offspring of a parent with an anxiety disorder who     had elevated symptoms of anxiety. In practice all children but one had at least one anxiety     disorder at baseline. Children were blocked on presence or absence of parental anxiety     disorder and randomized to the intervention or to a no-intervention wait-list control group.     The intervention consisted of 6 parent-only sessions, 8-13 child-parent sessions, and a final     parent session. Post-trial assessments were conducted at six months, and at one-year     follow-up. The hypotheses were that the children assigned to the intervention group would     show significantly better improvement (measured via Clinician Global Impression-Anxiety     Improvement scale and absence of anxiety disorders) than children assigned to the wait-list     condition.   "
230014|NCT00865319|"     This is a multiple-center Phase 2 study designed to expand the patient safety and clinical     information using 99m Tc-Ec-DG with Spect/CT imaging, to develop procedures and methods for     evaluation of the imaging studies, to determine comparability of diagnostic information     between SPECT and SPECT/CT imaging and to to compare the safety and efficacy of 99m Tc-EC-DG     SPECT/CT with 18F-FDG PET/CT in imaging patients with biopsy confirmed diagnosis of Non-small     Cell Lung Cancer.   "
230015|NCT00865332|"     Background:        -  Brain imaging studies, genetic research, and investigations of stress have provided more          information about the role of dopamine in processing reward and punishment, and in          vulnerability to substance dependence. Researchers are interested in learning more about          how the brain responds to rewards, including drugs of abuse, and how these responses may          involve genetic factors or previous stressful events.        -  Researchers intend to use the drug amphetamine to increase levels of dopamine in the          brain and study the effects through two kinds of scanning: functional magnetic resonance          imaging (fMRI) and positron emission tomography (PET).      Objectives:        -  To examine the relationship among dopamine function, brain activity, reward processing,          genetic profile and exposure to stress in normal healthy adults.        -  To examine the variation in these factors between normal healthy adults and individuals          with current cocaine-dependence.      Eligibility:      - Individuals 18 to 45 years of age who are either current cocaine users or healthy     volunteers with no history of substance abuse or dependence.      Design:        -  The study will consist of an initial evaluation session and six study visits, four of          which will involve fMRI scans (3 hours each) and two of which will involve PET scans (8          to 9 hours each).        -  Cocaine-using participants will enter the inpatient clinical research ward at the          National Institute on Drug Abuse Addiction Research Center the night before each          scanning session and will be discharged the following day. Healthy volunteer subjects          will not be required to stay overnight and will arrive as outpatients for the PET          session. Participants will not be released until researchers have determined that          participants are not experiencing significant effects of the drug.        -  Initial session (1): Participants will complete questionnaires about past reactions to          stressful situations, and will be trained to do thinking tasks that will be performed in          fMRI visits. The tasks will be practiced in a mockup of an MRI machine.        -  MRI sessions (2-5): Participants will receive either oral amphetamine or a placebo, and          will perform thinking, short-term memory, and reward tasks during MRI scanning as          directed by researchers.        -  PET sessions (6-8): Participants will receive either oral amphetamine or a placebo, and          will provide blood samples during the PET scanning sessions. Participants will have          short breaks during the PET scanning sessions.   "
230016|NCT00865345|"     The purpose of this study is to assess the performance of the subcutaneous glucose sensor     over an extended sensor life. The sensor is currently approved for 3 days of use and this     study will examine sensor safety and accuracy when used for six days. This study will also     test sensor safety and accuracy when inserted in an alternate body location (buttock area in     addition to abdomen area). The study hypothesis is that the sensor performance will not     greatly diminish when used for six days, or in an alternate insertion area.   "
230145|NCT00867100|"     This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered     as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe     psoriasis (Part B).   "
230017|NCT00865358|"     Chronic low back pain is the most common cause of pain in the United States. Common     treatments such as medication, physical therapy, and surgery often do not provide adequate     relief. Yoga has shown promise for improving low back pain in studies of predominantly middle     class white individuals. We will assess the feasibility and collect preliminary data on yoga     for chronic low back pain in predominantly minority individuals in a community health center     setting in a low income neighborhood of Boston, Massachusetts. We hypothesize that offering     yoga for this population is feasible and will show promising efficacy and safety data.   "
230018|NCT00865371|"     The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion     150 mg Extended-Release Tablet to that of Wellbutrin SR® 150 mg Tablet after a single,     one-tablet dose in subjects fed a standard meal.   "
230019|NCT00865384|"     The purpose of this study is to compare the relative bioavailability of 15 mg Mirtazapine     Tablets by Purepac Pharmaceutical Co with that of 15 mg REMERON® Tablets by Organon Inc.     following a single oral dose (1 x 15 mg) in healthy adult volunteers under non-fasting     conditions.   "
230020|NCT00865397|"     This study is conducted in Europe. The aim of this observational study is to evaluate     glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of     insulin therapy in Hungary.   "
230021|NCT00865410|"     The purpose of this study is to compare the rate and extent of absorption of Bupropion HCl     extended-release tablet (test) to that of Wellbutrin SR extended-release tablet (reference)     after a single, one-tablet (150 mg) dose in fasted subjects.   "
230022|NCT00865423|"     The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin     Tablets by Purepac Pharmaceutical Co. with that of 800 mg NEURONTIN® Tablets by Parke-Davis     following a single oral dose (1 x 800 mg) in healthy adult volunteers under fasting     conditions.   "
230023|NCT00865436|"     The purpose of this study is compare the relative bioavailability of 5 mg Glyburide/500 mg     Metformin Hydrochloride Tablets by Alpharma with that of 5 mg/500 mg CLUCOVANCE® Tablets by     Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy     adult volunteers administered under fasting conditions.   "
230024|NCT00865449|"     This is a double blind randomized controlled study to evaluate the effect of aldactone on     peritoneal fibrosis on incident peritoneal dialysis patients. The study would include a total     of 40 incident peritoneal dialysis patients. Peritoneal biopsy would be made at randomization     and 6 months after the intervention to evaluate the effect of renin angiotensin blockade on     peritoneal fibrosis.   "
230025|NCT00865462|"     The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion     150 mg XL Tablet to that of Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in     subjects fed a standard meal.   "
230026|NCT00865475|"     The aim of this study is to measure the prevention of lipoatrophy in patients treated with     Lopinavir/R in monotherapy versus ZDV + 3TC + ABC   "
230027|NCT00865488|"     The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing     and/or reducing post-operative adhesions in patients undergoing surgery involving the     ovaries.   "
230028|NCT00865501|"     The Renin-Angiotensin-Aldosterone-system is important in the development of cardiovascular     organ damage caused by arterial hypertension. This study aims at evaluating the importance of     aldosterone with regard to hypertension induced damage to the heart. In order to do this the     investigators will perform a comparative cross-sectional study in hypertensives and     normotensives. In addition as interventional part the hypertensives will be treated with a     mineralocorticoid-receptor blocker (spironolactone).   "
230029|NCT00865514|"     This project focuses on the kinetics, metabolism and human toxicology of dichloroacetate     (DCA)and tyrosine catabolism. The hypothesis is that tyrosine metabolism will be greatest in     subject who harbor the KRT variant for GSTz1/MAAI for which DCA exhibits a high Km.   "
230077|NCT00866177|"     This phase II trial is studying how well MEK inhibitor AZD6244 works in treating patients     with stage III or stage IV melanoma. MEK inhibitor AZD6244 may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth.   "
230030|NCT00865527|"     Colon cancer is the second leading cause of cancer death in North America. These deaths are     preventable with proper screening. Fecal occult blood testing, virtual colonoscopy, and     standard (optical) colonoscopy are all options for colon cancer screening, but it is not     known which is the best at preventing death from colon cancer. A large study comparing these     three tests is desperately needed. In this pilot study, the investigators want to find out     what percentage of patients will show up for their screening test once enrolled. This will     provide crucial information for the successful execution of the larger study.   "
230031|NCT00865540|"     The main objective of this study is to compare the effect of preoperative use of     anti-inflammatory topical prednisolone acetate 1%, nepafenac 0.1% and ketorolac tromethamine     0.4% of, plus a placebo, in maintaining the intra-operative mydriasis in extraction.   "
230032|NCT00865553|"     RATIONALE: A computer-assisted stop-smoking program may help doctors counsel patients who     smoke and may help increase the number of patients who stop smoking.      PURPOSE: This phase II trial is studying how well a computer-assisted stop-smoking program     works in helping doctors counsel patients who smoke cigarettes.   "
230033|NCT00865566|"     The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine     regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex     with men.      NOTE:      As of April 2013, all vaccinations in this study have been stopped.   "
230034|NCT00865579|"     Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a     progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of     dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a     precursor of DA that crosses the blood brain barrier, and also to the use of selective     inhibitors of MAO-B, the major DA metabolising enzyme in humans.      Safinamide is an inhibitor of MAO-B. This study is to evaluate the long term safety and     tolerability of safinamide in PD patients, that have already completed a previous clinical     study with Safinamide. The physical and neurological conditions as well as other safety     parameters will get compared from baseline to subsequent visits.   "
230035|NCT00865592|"     The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.   "
230038|NCT00865631|"     The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin     Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by     Parke-Davis following a single oral dose (1 x 800 mg tablet) or (2 x 400 mg capsules) in     healthy adult male volunteers under non-fasting conditions, and will compare the differences     in plasma levels after dosing the test formulation with and without food.   "
230039|NCT00865644|"     The purpose of this study is to determine if imiquimod cream can reverse the growth of     neurofibromas. Imiquimod is a skin cream that works by stimulating the body's immune system     to respond to tumors. Imiquimod cream is approved for use in patients with various skin     lesions, including actinic keratosis, superficial basal cell carcinoma, and external genital     warts. Information from these studies, as well as previous laboratory studies, suggest that     imiquimod cream may help shrink neurofibromas or keep them from growing.   "
230040|NCT00865657|"     The purpose of this study is to compare the relative bioavailability of 3 mg Alprazolam     Extended Release Tablets by Alpharma with that of 3 mg XANAX XR® Tablets by Pharmacia &     Upjohn Company following a single oral dose (1 x 3 mg extended-release tablet) in healthy     adult volunteers administrated under non-fasting conditions.   "
230041|NCT00865670|"     To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.   "
230042|NCT00865683|"     Women with excess adiposity while pregnant are more likely to develop gestational diabetes     and high blood pressure during pregnancy than women of healthy weights. This may occur     because overweight and obese pregnant women are less sensitive to insulin and have more     inflammation than pregnant women of healthy weights. This study will examine the effect of a     nutritional supplement, docosahexaenoic acid (DHA), on improving insulin sensitivity and     lessening inflammation in overweight and obese pregnant women.   "
230043|NCT00865696|"     The purpose of this study is to compare the relative bioavailability of 15 mg Mirtazapine     Tablets by Purepac Pharmaceutical Co with that of 15 mg REMERON® Tablets by Organon Inc.     following a single oral dose (1 x 15 mg) in healthy adult volunteers under fasting     conditions.   "
230044|NCT00865709|"     To determine if sorafenib when added to chemotherapy will slow disease progression more than     chemotherapy alone in patients previously untreated for metastatic colorectal cancer.   "
230045|NCT00865722|"     Background: Experimental studies suggest that remote limb ischaemic postconditioning     (RemPostCon) can reduce infarct size in pigs. Initial clinical applications support the     beneficial role of RemPostCon in preserving endothelial function during upper limb ischemia     in healthy volunteers and in patients with stable coronary artery disease.      Aim of the study: To evaluate the feasibility, safety and efficacy of RemPostCon in the     setting of STEMI and primary PCI (pPCI) and to investigate potential circulating mediators of     its effects.      Patients and methods: Patients who undergo pPCI for anterior STEMI within 6 hours since the     onset of symptoms are randomly assigned to receive either RemPostCon + pPCI or pPCI alone in     a single-blind fashion. All patients receive therapy according to the current international     guidelines. Three cycles of ischemia-reperfusion are provided to the lower limb inflating a     cuff to 200 mmHg. Each cycle consists of 5' of ischaemia, followed by 5' of reperfusion.     RemPostCon is started at the time of angioplasty in the infarct related artery. Primary     endpoint is the area under the curve (AUC) of creatinine kinase - MB (CK - MB). Cardiac     magnetic resonance (CMR) is performed early before discharge and 4 months after the event, if     there are no contraindications.   "
230046|NCT00865748|"     The purpose of this study is compare the relative bioavailability of 500 mg Metformin     Hydrochloride Extended Release Tablets by Alpharma with that of 500 mg CLUCOPHAGE® XR Tablets     distributed by Bristol-Myers Squibb Company following a single oral dose (1 x 500 mg     extended-release tablet) in healthy adult volunteers under fasting conditions.   "
230048|NCT00865774|"     The American College of Surgeons now requires screening for alcohol use in trauma centers.     The purpose of this research study is to provide information about the best screening and     treatment methods. The investigators hope the findings will provide information that will     improve healthcare by reducing problems related to risky alcohol use. The trauma team is     conducting a comparison of two different ways of talking about alcohol use. Participants will     be randomized into one of the two study groups.   "
230049|NCT00865787|"     This study is being done to determine if the use of EGCG-Enhanced Extra Virgin Olive Oil in a     daily diet will improve endothelial function.   "
230050|NCT00865813|"     The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in     diagnosing periocular malignancy.   "
230051|NCT00865826|"     An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV)     treatment in the coming year, with projected rates of requirement for ARV therapy extending     to more than 10 million in sub-Saharan Africa, southeastern Asia, and Latin America in the     coming decade. In these settings, Tuberculosis (TB) is an endemic infection in the     population, and an estimated 30-60% of adults have been infected with TB, the leading     opportunistic infection associated with HIV infection. The purpose of this study is to     construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in     identification of participants with active pulmonary TB, without sacrificing specificity.   "
230052|NCT00865839|"     The purpose of this study is to compare the relative bioavailability of 500 mg Metformin     Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co. with that of 500 mg     CLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 500     mg extended-release tablet) in healthy adult volunteers under fasting conditions.   "
230053|NCT00865852|"     The purpose of this study is compare the relative bioavailability of 750 mg Metformin     Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co with that of 750 mg     GLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 750     mg) in healthy adult volunteers under non-fasting conditions   "
230054|NCT00865865|"     Computer Aided Surgery in total knee arthroplasty improves knee stability and functional     outcomes more than conventional total knee arthroplasty.   "
230055|NCT00865878|"     The purpose of this study is to determine and compare the safety and efficacy of broad area     photodynamic therapy with aminolevulinic acid (ALA-PDT) versus vehicle PDT (VEH-PDT) in the     treatment of actinic keratoses (AK) and reduction of new non-melanoma skin cancer (NMSC) of     the scalp or both forearms in solid organ transplant recipient subjects receiving chronic     immunosuppressive therapy.   "
230056|NCT00865891|"     The purpose of this study is to compare the relative bioavailability of Nifedipine ER tablets     60 mg by Abrica Pharmaceuticals LLLP with that of ADALAT® CC Extended Release Tablets 60 mg     by Bayer Pharmaceuticals Corporation, Bayer HealthCare following a single oral dose (1 x 60     mg tablet) in healthy adult volunteers under fasting conditions.   "
230057|NCT00865904|"     The primary objective of the study was to evaluate the safety and tolerability of VX-809 in     participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF     transmembrane conductance regulator (CFTR) gene.   "
230058|NCT00865917|"     The study compares three treatment modalities in a human model of Postural orthostatic     tachycardia syndrome (POTS): beta-blockers, I(f)-blockers, and placebo.   "
230059|NCT00865943|"     The purpose of this study is compare the relative bioavailability of 10 mg Citalopram     Hydrobromide tablets by Purepac Pharmaceutical Co with that of 10 mg CELEXATM tablets     distributed and marketed by Forest Pharmaceuticals, Inc. following a single oral dose (1 x 10     mg tablet) in healthy adult volunteers under fasting conditions   "
230060|NCT00865956|"     Disease management (DM) programs are being increasingly utilized by health plans to     coordinate care, improve quality of care, and control costs in chronically ill individuals.     DM programs for specific medical conditions, such as diabetes mellitus, congestive heart     failure, and asthma, have demonstrated improvements in health outcomes and a number of     studies have found economic benefits to these programs as well. There are fewer data     evaluating multi-disease DM programs, and results have been mixed. Additionally, data on such     programs specifically targeting substance-using populations are limited, although they are     promising. Prior utilization and hospitalization data from Johns Hopkins Hospital, Johns     Hopkins Health Care, and Priority Partners Managed Care Organization (PPMCO) suggest that a     substantial portion of high-utilizing, high-cost, medically complex patients have a substance     use diagnosis.      The investigators hypothesize that a comprehensive DM program for medically-complex substance     users with a history of hospitalization, consisting of intensive nurse case management along     with behavioral incentives to reinforce engagement in primary care, can decrease inpatient     days and costs, as well as improve outcomes for substance use, depression, and physical and     mental functioning. The investigators will compare the case management/behavioral incentives     intervention to usual care among a group of medically-complex, substance-using, PPMCO     enrollees. Usual care will include access to all existing Priority Partners care management     programs, and usual The investigators believe that this research will make an important     contribution to the development of models of chronic care that improve health and promote the     best use of health care resources. Additionally, the investigators believe this project will     promote the study and development of systems to improve the health of substance-using adults,     an underserved and often marginalized group.   "
230061|NCT00865969|"     The purpose of this study is to assess efficacy and safety of belinostat in patients with     relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior     systemic therapy.   "
230062|NCT00865982|"     In this study, patients with adenocarcinoma of the stomach, gastro-esophageal junction or the     distal esophagus who seem operable with curative intent according to oncological and surgical     assessment are treated with 3 preoperative cycles of DCX (Docetaxel, Cisplatin, Capecitabine)     followed by surgical resection, followed by 3 postoperative cycles of DCX.   "
230063|NCT00865995|"     Evaluation of tracheal pepsin as a biomarker for aspiration   "
230064|NCT00866008|"     Background:      By limiting the number of embryos transferred to the uterus to only a single embryo, the risk     of multiple gestation can be reduced. In order to improve the effectiveness of single embryo     transfer, the ability to select the embryo with the highest potential to develop into a     healthy child is of vital importance. While embryos rated as high quality by standardized     morphological assessment are associated with higher implantation and pregnancy rates, it is     still not possible to predict with certainty which embryo will implant and has the highest     potential to develop into a healthy child. An increasing body of evidence indicates that the     incidence of chromosomal abnormalities in embryos is extremely high and good embryo     morphology does not necessarily exclude an abnormal chromosomal constitution. Since     aneuploidies are considered the main cause of embryonic wastage and loss, this phenomenon may     be primarily responsible for the relatively poor pregnancy rates reported after IVF.      The introduction of fluorescent in-situ hybridization (FISH) techniques for preimplantation     genetic diagnosis has enabled screening of embryos for chromosomal aneuploidies before     transfer. Preimplantation genetic screening (PGS) would be of special interest for couples     that are thought to have a higher risk of developing chromosomally abnormal embryos, with the     aim of improving their chances for an ongoing pregnancy after IVF. PGS is applied clinically     in numerous IVF laboratories throughout the world, and high rates of chromosomal     abnormalities have been reported in IVF derived embryos. However, a recent meta-analysis has     shown that PGS is yet to have a significant impact on IVF outcomes. This may partly be     explained by the fact that most aneuploidies observed at this stage originate during the     first mitotic divisions of early preimplantation development, resulting in chromosomally     mosaic embryos. If a chromosomally mosaic embryo is biopsied, this cell may not be     representative for the remaining embryo.      The investigators' group recently completed the first prospectively designed, randomized     trial, comparing embryo aneuploidy rates following two ovarian hyperstimulation regimes in a     group of 111 IVF patients. Milder stimulation was associated with a reduction in the number     of oocytes retrieved and embryos generated. However, the proportion of chromosomally normal     embryos was significantly increased. These results showed for the first time a direct     correlation between the ovarian stimulation protocol and the incidence of chromosome     abnormalities in the embryo. The observation that mild stimulation in some patients still     resulted in a high oocyte yield and concurring higher proportions of abnormal embryos,     underscores the need for further development of minimal stimulation approaches.      Primary Objective:      To determine whether the administration of hCG during the late follicular phase, instead of     continuing with a fixed dose FSH, results in a more homogeneous cohort of growing follicles     and the development of only the most competent oocytes, leading to lower aneuploidy rates in     resulting embryos.      Study design:      Prospectively randomized, clinical study in 110 women undergoing IVF treatment      Intervention:      Randomization to one of two ovarian stimulation protocols:        1. Conventional regimen with a daily dose of 225 IU recombinant FSH and GnRH agonist long          protocol co-treatment        2. Mild ovarian stimulation regimen using the endogenous FSH production by starting          treatment on day 5 of the menstrual cycle with 150 IU / d recFSH with GnRH antagonist co          treatment starting on day 6. As soon as two follicles reach 12 mm, treatment is          continued with 200 IU / d rec hCG.      In both arms, oocyte pick up, insemination and embryo culture will be performed according to     standard procedures. On day 3, all suitable embryos will be biopsied and one or two     blastomeres removed, depending on the number of cells within the embryo.      FISH analysis will be performed for 10 chromosomes (1, 7, 13, 15, 16, 18, 21, 22, X and Y).     Only chromosomally normal embryos will be transferred and cryopreserved. Embryos diagnosed as     aneuploid or mosaic will be investigated for their implantation and developmental potential,     by transferring them to an in vitro implantation model. After an extended culture period,     implantation behaviour will be assessed and the entire embryo is reanalysed to detect the     proportion of chromosomally abnormal cells. The implantation behaviour will be correlated to     the type of abnormality and the chromosome(s) involved.      Primary outcome parameters:      Ovarian response, as assessed by the number of oocytes obtained and the proportion of     chromosomally abnormal embryos per patient.      Secondary outcome parameters:      Number of oocytes retrieved, fertilization rates and proportion of morphologically high     quality embryos on day 3.      Serum estradiol, LH, progesterone, androgen and hCG levels on cycle day 3 and day of hCG.   "
230065|NCT00866021|"     The aim of this study is to assess the efficacy of lopinavir/r in monotherapy and     peg-interferon plus ribavirin for the control of both HIV and HCV infection respectively     after 12 months of active treatment for HCV.   "
230075|NCT00866151|"     The goal of this study is to determine the association between genotypes and diet. The weight     and weight loss data are already available from the previously completed study called: A to Z     Study - Benefits and Risks of Alternative Weight Loss Strategies - A Clinical Trial, which     was performed from 2003-2005 at Stanford University. In the present study, Interleukin     Genetics will obtain DNA samples from the previously enrolled study subjects to investigate     genetic influence of the response to macronutrient compositions of low caloric diets to     weight loss.   "
230066|NCT00866034|"     Rationale:      In daily practice fertility treatment is increasingly patient focused and innovative     medication and standardized treatment guidelines are being developed to improve patient     convenience.      GnRH antagonist cotreatment to prevent premature luteinization during ovarian stimulation for     IVF and ICSI greatly reduces the burden of treatment, partly by reducing the number of     injections by around 21 compared with the optimal GnRH agonist 'long' protocol. However, the     optimal GnRH antagonist protocol is still not known. There are a number of reasons to suggest     that both the simplicity of treatment and clinical outcomes could be further improved by     commencing GnRH antagonist treatment on the same day on which ovarian stimulation is started.     These include more synchronized follicle development and reduced rates of premature     luteinization. This study will investigate whether a novel early fixed start protocol     improves outcomes in comparison to the widely employed late fixed start protocol.      Objective:      To demonstrate whether an early fixed start antagonist protocol improves the live birth rate     compared with a late fixed start antagonist protocol by 5%.      Study design:      Prospective, multicenter, investigator sponsored, randomized controlled trial      Study population:        -  Normo-ovulatory women < 39 years with an indication for IVF or ICSI        -  No more than 2 previous unsuccessful IVF/ICSI cycles        -  BMI ≤ 32 kg/m2      Intervention:      Two different GnRH antagonist treatment protocols used in daily practice will be compared.     Patients will be randomized to receive one of the following two treatments:        -  Early fixed start: start GnRH antagonist treatment with Cetrotide 0.25 mg on the same          day as FSH, cycle day 2.        -  Late fixed start: FSH will be administered from cycle day 2. GnRH antagonist treatment          with Cetrotide 0.25 mg will commence on cycle day 6.      Main study parameters/endpoints:      The primary endpoint is the live birth rate per started cycle. A secondary endpoint is the     number of embryos available for transfer.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      In addition to recording clinical outcomes, endocrine studies will be carried out at the UMC     Utrecht in a sample of 200 participants who will be subjected to blood sampling at three     points during the treatment cycle: prior to commencing treatment on cycle day 2, cycle day 6     and the day of hCG administration.The aim of this substudy was therefore to prospectively     compare the effect of a cycle day 2 versus cycle day 6 fixed start GnRH antagonist protocol     on LH, estradiol and progesterone levels in the mid and late follicular phase. In order to     investigate whether the early fixed protocol exerts a significant extra burden on patients     compared to the late start protocol, another group of 200 participants at the UMCU will be     requested to complete the HADS questionnaire (Hospital Anxiety and Depression Scale).   "
230067|NCT00866047|"     This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and     safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or     refractory ALCL.   "
230083|NCT00866255|"     Continuous measurement of intratracheal pressure in mechanically ventilated infants using a     fibreoptic pressure transducer in the endotracheal tube (ETT). Based on the findings,     tracheal pressure can continuously be monitored in the presence of pediatric ETTs by     combining ETT coefficients and the flow and airway pressure continuously measured at the     proximal end of the ETT.   "
230084|NCT00866268|"     Principal hypothesis:      A low suction drainage (-50 mmHg) reduce a 25% the blood loss with respect a standard closed     drainage (-700 mmHg) following total knee arthroplasty.   "
230085|NCT00866281|"     This is a phase I/II pediatric dose-ranging study that will evaluate the safety,     tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in     patients <18 years of age who have relapsed or refractory acute leukemias that may benefit     from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.   "
230068|NCT00866060|"     The trial will examine whether pharmacological treatment with donepezil, memantine or     combination of memantine and donepezil is any better than a placebo (dummy) treatment in     people with Alzheimer's disease who have reached the moderate to severe stage of illness.     Using a double blind design, where neither the investigators nor participants know who is     receiving which treatment, participants will be randomly assigned to one of these four     treatment groups (donepezil and memantine, memantine only, donepezil only or placebo). In     order to keep both the investigators and participants blind to drug allocation a double dummy     design will be necessary. This means that each participant will receive 2 treatments − either     an active form or placebo of each of the 2 study drugs.      Hypotheses are:        1. Patients with Alzheimer's disease (AD) who continue donepezil beyond the point of          transition from moderate to severe dementia continue to show significantly less decline          on ratings of cognitive function and activities of daily living over the following 12          months than those discontinuing donepezil.        2. Patients with AD who change to memantine therapy in place of donepezil at the point of          transition from moderate to severe dementia show significantly smaller decline on          ratings of cognitive function and activities of daily living over the following 12          months than those who receive placebo.        3. Patients given the combination of memantine and donepezil at the point of transition          from moderate to severe dementia show significant additive or synergistic benefits on          measures of activities of daily living and cognitive function after 12 months compared          to those patients continuing on either drug as a single treatment.   "
230069|NCT00866073|"     This study is an open-label phase II trial to investigate the efficacy and toxicity of     low-dose decitabine (5-aza-2'-deoxycytidine) in elderly patients with acute myeloid leukemia     (AML) not eligible for aggressive induction chemotherapy. AML patients above the age of 60     years (no upper age limit) who have not previously received and are not eligible for,     standard induction treatment of their disease will be eligible for this trial. Decitabine     will be administered as a 3 hour infusion at 15 mg/m2 three times daily on three consecutive     days (total dose 135 mg/m2). In all patients with > 20000 WBC/µl, this treatment will be     repeated 1 week later. In patients with white blood cells exceeding 50 000/μl, decitabine     treatment will be preceded by cytoreductive doses of hydroxyurea.   "
230070|NCT00866086|"     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the     tumor and cause less damage to normal tissue. Abdominal compression methods that hold the     body and the tumor from moving during treatment may permit radiation therapy to kill more     tumor cells. This study is looking at the comfort level of two abdominal compression methods     in patients with lung tumors undergoing stereotactic body radiation therapy.      PURPOSE: This phase I trial is studying the comfort level of two abdominal compression     methods used to hold patients still while undergoing stereotactic body radiation therapy for     lung tumors.   "
230071|NCT00866099|"     The purpose of this study is to develop and test an educational intervention for dementia in     primary care, combining timely diagnosis, psychosocial support around the period of diagnosis     and management concordant with guidelines.   "
230072|NCT00866112|"     People with mobility disabilities are at greater risk than the general population for     incurring health problems. Many of these conditions are preventable through behavior and     lifestyle changes such as exercise and physical activity. Recent evidence suggests that     people with disabilities experience the same physiologic response to exercise as the general     population. Nonetheless, nearly three-fourths of those with disabilities report being     entirely sedentary or not active enough to achieve health benefits. Despite some knowledge of     issues that limit physical activity among this population, few studies have investigated     methods for promoting physical activity adoption among people with disabilities, including     wheelchair users. The purpose of this study is to test the effectiveness of a behavioral     intervention to promote physical activity adoption over 6 months and maintenance of physical     activity over another 6 months by community-dwelling manual wheelchair users.   "
230073|NCT00866125|"     The aim of this study is to investigate the hand function in patients with poly-and     dermatomyositis and compare this to healthy individuals and norm values and secondly if hand     function correlates to activity performance and health related quality of life.      The study is a cross-sectional study. To assess hand function the investigators will measure     grip force with Grippit and arm/hand mobility using EPM-ROM scale. The activity performance     will be measured with Myositis Activities Profile and health related quality of life will be     assessed with SF-36.      The investigators' hypothesis is that hand function is reduced in comparison to the healthy     population and that hand function affects both activity performance and health related     quality of life.   "
230078|NCT00866190|"     The purposes of this study are to determine: how safe it is to take SQ109 (an experimental     tuberculosis treatment) once a day by mouth for up to 2 weeks in 2 different dosages; how     well the body accepts it; how SQ109 enters and leaves the body and blood tissues over time;     the amounts that can be detected in the blood; and how long it stays in the body. The study     involves 30 volunteers: 24 will receive SQ109 and 6 will receive placebo (inactive     substance). Qualified participants will be admitted to the study unit within 28 days from the     screening and stay as inpatient for approximately 2 weeks. During this period they will     receive study drug and complete all scheduled procedures including multiple blood draws.     After discharge, there is a 14 day follow up period. Total study participation is about 56     days.   "
230079|NCT00866203|"     The study is planned to compare the outcome of aggressive NHL patients in partial remission     after four courses of front-line therapy, randomly assigned to receive either additional four     courses of the same regimen or a modified HDS program.   "
230080|NCT00866216|"     The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate     600 mg Tablets.   "
230081|NCT00866229|"     Early statin therapy in SLE patients that have high cholesterol level and other     atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course     of disease. By the way, statin is used in restricted groups of rheumatologists due to     awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients     more so than other groups of atherosclerosis patients and reporting data of autoimmune     diseases that occur after statin use.   "
230082|NCT00866242|"     The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral     vaccine) is safe and effective in the prevention of Shigella infection.   "
230086|NCT00866294|"     This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the     efficacy of controlled-release (CR) formulation of paroxetine orally administered to patients     with major depressive disorder (MDD) at a dose level in the range of 25 - 50 mg/day (initial     dose level, 12.5 or 25 mg/day) once daily after evening meal for 8 weeks based on the     decrease in HAM-D (Hamilton Depression Rating Scale) total score, to evaluate the safety     based on adverse events, laboratory data and vital signs, and to describe the efficacy and     safety of immediate release (IR) formulation of paroxetine.   "
230087|NCT00866307|"     This pilot clinical trial studies the side effects of pegaspargase when given together with     combination chemotherapy in treating patients with newly diagnosed high-risk acute     lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop     the growth of cancer cells, either by killing the cells, by stopping them from dividing, or     by stopping them from spreading. Giving more than one drug (combination chemotherapy)     together with pegaspargase may kill more cancer cells.   "
230088|NCT00866320|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with     metastatic kidney cancer that has not responded to sunitinib or bevacizumab.   "
230089|NCT00866333|"     This study will evaluate the efficacy and safety of entinostat, SNDX-275, in patients with     relapsed or refractory Hodgkin's lymphoma.   "
230090|NCT00866346|"     Primary Objective:      To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes     (PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after     allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor.      Secondary Objectives:        1. To evaluate the immunological response following PR1-CTL treatment        2. To evaluate the clinical efficacy by determining clinical, cytogenetic and molecular          response rates within 6 months   "
230091|NCT00866359|"     The purpose of this study is to assess whether Apremilast is safe and effective in the     treatment of patients with Behcet Disease.   "
230092|NCT00866385|"     A study designed to look at how the drug AZD8566 is taken up by the body when given with or     without food. In some subjects a comparison will be made with a very small labelled microdose     given into a vein.   "
230093|NCT00866398|"     Since the advent of coronary stents, in-stent restenosis has proven to be the major     limitation of interventional cardiology, occurring in as many as 30% of patients.     Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis.     They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer,     and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel     wall and stops the process of neointimal hyperplasia, thereby significantly reducing the     incidence of in-stent restenosis.      The study Economic Evaluation of the German Drug-Eluting Stent Registry examines the     cost-effectiveness of drug-eluting stents compared to bare-metal stents (BMS) in patients     with coronary stenosis. The goal of the study is to examine whether the guideline-supported     implantation of SES, despite the higher initial cost, improves the quality and economic     outcomes of the treatment of patients with coronary stenosis. Secondarily, the study     evaluates patient quality of life, impairment of daily activities, and re-intervention rates.   "
230094|NCT00866411|"     The purpose of this double-blind randomized control research study is to determine if CES     given in a group setting for soldiers experiencing irritability is effective to reduce the     symptom of irritability.   "
230096|NCT00866437|"     The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex     hormones, among women suffering from severe PreMenstrual Syndrome (PMS).      The system includes skin testing panel for identification of hormones to which the patients     might be sensitive. Tests are applied close to the ovulation period and the skin reaction is     examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests     and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic     tool for severe PMS patients.   "
230097|NCT00866450|"     This study will look at the inflammatory (changes usually associated with infection/injury to     the body) and bowel permeability (bowel's ability to allow contents to enter the body)     effects of a Western-style diet (high fat and low in calcium) and a prudent-style diet (low     fat and high in calcium) on the colon (large bowel). This study may provide information to     prevent colorectal cancer in a high-risk population   "
230098|NCT00866463|"     This study to will compare the blood levels of sildenafil following administration of an     experimental tablet vs. the conventional oral tablet.   "
230099|NCT00866476|"     The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral     vaccine) is safe and effective in the prevention of Shigella infection.   "
230100|NCT00866489|"     The current study is designed to clarify the neuroprotective effect of remote ischemic     precondtioning on the patients underwent neurosurgery.   "
230101|NCT00866502|"     This study is conducted to evaluate the safety and tolerability of the drug product sNN0031,     containing Platelet Derived Growth Factor (PDGF), when administered directly into one of the     fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed®     II pump. Patients with a diagnosis of Parkinson's disease will be enrolled.   "
230102|NCT00866515|"     This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover     study in healthy male and female subjects. There will be two treatment periods each     consisting of 7 days. During each treatment period subjects will receive single doses of     ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the     morning of Day 5.   "
230103|NCT00866528|"     The Phase I part of the study will identify the doses of pazopanib and paclitaxel that can be     administered safely in combination. The Phase II part of the study will not be progressed as     documented in Protocol Amendment 01.   "
230104|NCT00866541|"     Flow proportional pressure support (FPPS) is a new mode of spontaneous breathing assistance.     In patients with increased respiratory resistance the role of FPPS in comparison with the     pressure support assist breathing mode is still unclear. In this study the investigators     evaluate objective and subjective measured data in healthy volunteers with artificial     increased resistance and FPPS breathing assistance.   "
230108|NCT00866593|"     The primary objective of this study is to evaluate the efficacy and safety of Generic     Escitalopram in the treatment of Chinese patients with depression compared with Innovator     Escitalopram(Lexapro®) by evaluating the change of HAMD-17 total score from the baseline to     week 8.   "
230109|NCT00866606|"     This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in     Chinese hemophilia B subjects.   "
230110|NCT00866619|"     The purpose of this observer-blind study is to gather key efficacy, safety, and     immunogenicity information on GSK's candidate malaria vaccine in infants and children.   "
230111|NCT00866632|"     The purpose of the study is to investigate the potential benefits of a psychological therapy,     called cognitive behaviour therapy (CBT), for improving emotional well being after acquired     brain injury and to demonstrate its efficacy in both under telephone (T-CBT) and face-to-face     group (G-CBT) modes of delivery compared to an educational control group.   "
230112|NCT00866645|"     The primary objective of this study is to evaluate the efficacy and safety of Intramuscular     Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared     with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of     study (72 hours after first dosing) from baseline.   "
230113|NCT00866658|"     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in     comparison to placebo, as an add-on treatment to basal insulin with or without sulfonylurea,     over a period of 24 weeks of treatment.      The primary objective is to assess the effects of lixisenatide, when added to basal insulin,     on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24.      The secondary objectives are to assess the effects of lixisenatide on body weight, 2-hour     postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of     patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less     than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma     glucose (SMPG) profiles, change in daily basal insulin and total insulin doses; to evaluate     safety, tolerability, pharmacokinetics (PK), and anti-lixisenatide antibody development.   "
230114|NCT00866671|"     This international, multicentre, single arm, phase IV study will assess the safety and     efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage     acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not     responded to or has relapsed following treatment with at least two chemotherapy regimens. It     is a post-authorisation safety study (PASS) conducted for the purpose of confirming the     safety profile and the clinical benefit of nelarabine under licensed conditions of use. The     study is observational, non-interventional, and will include approximately 40 children and     young adults (up to 21 years of age).   "
230139|NCT00867009|"     This study will estimate the response rate in patients with advanced or metastatic     non-squamous Non-Small Cell Lung Cancer. Patients who don't progress after 4 to 6 cycles of     induction treatment with pemetrexed, cisplatin and cetuximab will receive maintenance     treatment with pemetrexed and cetuximab.   "
230115|NCT00866684|"     Transplant recipients have a high risk to develop skin malignancies. This effect depends on     the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on     the other hand on the dosage (i.e., calcineurin-inhibitors). Based on the encouraging results     of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients     should be switched to an immunosuppressive regime including SRL, decreasing the dosage of     calcineurin-inhibitors or converting from former immunosuppression. A conversion to a     SRL-based therapy is effective in immunosuppression and safe regarding graft and patient     survival.      This study was designed to assess whether a switch to a SRL-immunosuppressive therapy     decreases the incidence/reoccurrence of skin neoplasm.   "
230116|NCT00866697|"     This is a study to determine whether therapy with pazopanib is effective and safe in women     with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer has not     progressed on first line chemotherapy.   "
230117|NCT00866710|"     Background: Parkinson's disease affects up to 3% of persons over the age of 65. Lower urinary     tract symptoms are a frequent cause of diminished quality of life in elderly persons and     occur in up to 40% of persons with Parkinson's disease. While the exact mechanisms have not     been determined, detrusor hyperactivity (hyperactivity of the bladder muscle) leading to     symptoms of overactive bladder and urge incontinence is common. Behavioral and exercise-based     therapies have relatively no side effects and have been shown to be an effective treatment     for urge symptoms of overactive bladder in the aged population.      Hypothesis and Specific Aims: Behavioral therapy using pelvic floor muscle exercises will     result in a 50% decrease in the number of incontinence episodes in elderly persons (age > 50)     with Parkinson's disease. The specific aims for this pilot study include the following:        1. Complete a course of behavioral therapy using computer-assisted biofeedback in 20          subjects with UI associated with PD and determine how many potential subjects need to be          screened and enrolled to achieve this sample size.        2. Determine the proportion of these patients who achieve a 50% or greater reduction in UI          episodes.        3. Examine whether responsiveness is associated with characteristics of the Parkinson's          disease, in particular disease severity as measured by the Unified Parkinson's Disease          Rating Scale (UPDRS).        4. Assess the effectiveness of behavioral therapy without the use of computer-assisted          biofeedback instruction in 10 additional subjects with PD and UI.      Methods: The first 20 participants will be enrolled in an 8-week treatment trial of     behavioral therapies and pelvic floor muscle exercises with computer-assisted biofeedback.     Ten additional participants will be enrolled in the 8-week treatment trial of behavioral     therapy, but will not have computer-assisted biofeedback. Voiding diaries as well as urinary     symptom and quality of life questionnaires will be used to assess response.      If persons with Parkinson's disease can complete the treatment trial and achieve a reduction     in episodes of urinary incontinence with behavioral techniques this would lay the foundation     for a larger, placebo-controlled trial. Assessment of responsiveness associated with severity     of Parkinson's disease would also provide important information about the utility of this     treatment strategy.   "
230118|NCT00866723|"     The purpose of this study is to evaluate how the participant's disease (ovarian, primary     peritoneal serous, fallopian tube, or papillary serous endometrial cancer) responds to     additional treatment with Avastin (bevacizumab). Participants have already received Avastin     as part of maintenance therapy for their cancer. Maintenance therapy is a medical therapy     that is given to people to prevent a relapse. However, cancer may return after maintenance     therapy. This research study hopes to determine whether additional treatment with Avastin     will be effective in treating the participant's cancer.   "
230119|NCT00866736|"     The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject     with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of     imatinib mesylate.   "
230146|NCT00867113|"     This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The     purpose of this trial is to evaluate the use of long term adjuvant imatinib mesylate in     patients at significant risk for recurrence following complete resection of primary GIST.   "
230120|NCT00866749|"     Objectives:      A. Primary objective:      1 To assess the feasibility and the effectiveness of pediatric type therapy (augmented BFM)     in patients age 12 through 40 with untreated precursor-B or T acute lymphoblastic leukemia     (ALL) or lymphoblastic lymphoma (LL).      B. Secondary objective:        1. To evaluate the prognostic significance of minimal residual disease in bone marrow          samples at the end of induction and at the end of consolidation in this group of          patients.        2. To prospectively evaluate gene hypermethylation status in this group of patients.        3. To prospectively analyze asparaginase activity and anti-asparaginase antibody formation          in this population of patients.   "
230121|NCT00866762|"     The aim of the present study is to evaluate the efficacy and safety of MK-0683 in the     treatment of PV and ET. This agent has most recently been shown to be a potent inhibitor of     the autonomous proliferation of haematopoietic cells of PV and ET patients carrying the JAK2     V617F mutation. Accordingly, it may be anticipated that MK-0683 - by decreasing the JAK2     allele burden - may influence clonal myeloproliferation and in vivo granulocyte, platelet and     endothelial activation , which are considered to be major determinants of morbidity and     mortality ( thrombosis, bleeding, extramedullary haematopoiesis , myelofibrosis ) in these     disorders. The effects of MK-0683 at the molecular level will be studied by global/ focused     gene expression profiling, epigenome profiling and proteomics.   "
230122|NCT00866775|"     This is an 18-week, double-blind, multicenter study with gradual conversion from previous     antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial     epilepsy.   "
230123|NCT00866788|"     The study is a Phase II, dose-ranging, multicenter, randomized, double-blind,     placebo-controlled, parallel-group study of the efficacy and safety of a single     subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent     and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic     despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll     approximately 76 patients at approximately 45 study centers in the United States and Germany.   "
230124|NCT00866801|"     The central hypothesis in the present project is that general anesthesia may alter autonomic     control such that perioperative coronary blood flow (CBF) is significantly disturbed.      These disturbances in coronary blood flow may contribute to the development of myocardial     ischemia in the perioperative period. Furthermore, patients with an intrinsically altered     autonomic sympathetic innervation, like diabetics, are even more prone to develop     perioperative disturbances in coronary blood flow.      Here the researchers will investigate what the direct effects are of general and locoregional     anesthesia on the CBF. Furthermore, the researchers aim to evaluate whether diabetic subjects     show more disturbed CBF responses to anesthesia as compared to non-diabetics.   "
230125|NCT00866814|"     This study will collect data on patients undergoing hernia repair using the Bard Ventrio     Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of     life and complications associated with the device and surgical procedure.   "
230137|NCT00866983|"     The purpose of this study is to provide sildenafil therapy to patients who completed the     A1481244 study for the treatment of PAH, and reside in Brazilian States where Revatio™ is not     supplied by Health Secretary, and are judged by the Investigator to derive clinical benefit     from continued treatment with Sildenafil. It will be supplied until patient gets access to     Sildenafil through Brazilian State Health Secretary from where patient resides.   "
230126|NCT00866827|"     Controversy exists in the treatment of airway hemangiomas ranging from tracheotomy, various     lasers, to open removal, none of which have proven to be a gold standard. Venous     malformations of the airway are difficult to treat and also require laser therapy or open     removal and often repeated treatments are required. Similarly airway lymphatic malformations     can require multiple treatment modalities as well as multiple procedures and are infrequently     eradicated when extensive. New uses for various lasers and differing treatment protocols are     frequently developed. Review of the treatment modalities and efficacy of these methods is     required. The goal of this research is to determine protocols for treatment of airway     vascular malformation and to evaluate our results from treatment of these lesions.   "
230127|NCT00866840|"     RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective     treatment for melanoma.      PURPOSE: This phase II trial is studying how well riluzole works in treating patients with     stage III or stage IV melanoma that cannot be removed by surgery.   "
230128|NCT00866853|"     The purpose of this study is to determine whether TMC435 influences the activity of certain     drug-degrading proteins in the human body. The drug-degrading proteins investigated in this     study belong to the Cytochrome P (CYP) family and are called CYP1A2, CYP2C9, CYP2D6, CYP3A4     and CYP2C19. The activity of these drug-degrading enzymes are determined by measuring the     blood levels of a selected set of drugs, which are taken together with TMC435, and, which are     known to be specifically degraded by a certain member of the CYP family. This selected set of     drugs (which are taken together and therefore called a drug cocktail) are considered as     probes of these respective drug-degrading enzymes. By measuring the levels of these probes     in human blood, the activity of these degrading enzymes are being revealed. In this way, we     can determine if TMC435 influences in one way or another the activity of one or several of     these selected drug-degrading proteins.   "
230129|NCT00866866|"     Chronic sinonasal symptoms (CSNS), such as coughing, throat clearing, nasal obstruction,     crusting, dryness and discharge are extremely common in the general population. Although the     physical symptoms are readily apparent, the psychosocial impact is often overlooked.     Depression, anxiety, fear of social interaction, impaired personal relationships and     decreased performance at work have all been associated with CSNS, often leading to multiple,     frequent visits to the patient's primary care physician. A variety of clinical studies have     shown that health-related quality of life (HRQoL) is significantly impaired in people with     CSNS, with depressive symptoms being particularly common.      CSNS may be due, in part, to tenacious nasal and paranasal secretions. It is therefore     conceivable that a mucolytic may thin these secretions and improve mucociliary clearance,     thereby reducing CSNS. N-acetylcysteine (NAC) is the most widely used mucolytic agent,     particularly in patients with cystic fibrosis (CF), and has been documented as the most     effective of the mucokinetic agents. Our group wishes to examine the use of NAC as a     treatment for CSNS by testing the hypothesis that oral NAC reduces symptoms of CSNS compared     to placebo.   "
230130|NCT00866879|"     This study is being done to investigate the impact of changing immunosuppressive medications     from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant.     The primary purpose of this research study is to evaluate whether the use of mycophenolate     mofetil(MMF)/Cellcept® and tacrolimus(TAC)/Prograf® (Group 1) or mycophenolate     mofetil(MMF)/Cellcept® and sirolimus/Rapamune® (Group 2) impacts the incidence of acute     cellular rejection in post kidney transplant patients. This study will examine whether     switching from tacrolimus to sirolimus will better preserve long-term kidney function.   "
230131|NCT00866892|"     Most pediatric lacerations occur indoors and are considerably noncontaminated. Wounds that     occur outside of the house where dirt often enters the laceration, irrigation and scrubbing     with soap has been proven effective at decreasing post-laceration infections. To date there     are no pediatric prospective studies addressing a less aggressive approach to face and scalp     wound preparation in pediatrics. We argue that wiping wounds with sterile gauze soaked in     sterile saline will not increase infection rates as compared to our current practice. In our     emergency departments, the current standard of care for all lacerations is aggressive wound     preparation: irrigation and scrubbing. This occurs regardless if the wound is contaminated or     not. Research has proven that irrigation and scrubbing is unwarranted in adults with face and     scalp lacerations. We want to perform a pilot/feasibility study comparing our two emergency     campuses. One campus will serve as the control site, while the other will be the intervention     site. In this pilot study, our goal is to demonstrate the feasibility of the intervention and     provide data that a less aggressive approach to wound preparation is just as effective as our     standard of care. We hope this project leads to further discussion about how we manage     noncontaminated lacerations and provides a stepping-stone to a larger, appropriated powered     study.   "
230132|NCT00866905|"     We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant     treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for     docetaxel, since preclinical and clinical      studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The     combination of ixabepilone and cyclophosphamide could further improve the efficacy of     non-anthracycline neoadjuvant therapy.   "
230133|NCT00866918|"     This phase III trial is studying combination chemotherapy to see how well it works in     treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more cancer cells.   "
230134|NCT00866944|"     The purpose of this study is to determine the effect of adecatumumab alone or following     FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to     compare the effect to FOLFOX alone.   "
230135|NCT00866957|"     The purpose of the study is to compare levels of HIF-1 α (Hypoxia Inducing Factor 1-alpha) in     patients who have been treated with various types of liver cancer treatments.   "
230136|NCT00866970|"     The purpose of this study is to asses the safety and efficacy of ALD518 in patients with     Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).   "
230138|NCT00866996|"     The purpose of this study was to better understand the treatment outcomes of extended-release     methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorder     (ADHD) as evaluated by physicians and parents in a community setting.   "
230140|NCT00867022|"     Through complex hormonal pathways, insulin resistance can lead to the activation of the     sympathetic nervous system, and vice versa. Schobel et al. showed that in PE patients,     mus-cle sympathetic nerve activity (MSNA) is increased compared with normotensive pregnant     and non-pregnant women. Studies assessing heart-rate variability and plasma noradrenalin     concentrations also suggest increased sympathetic activity in PE. It has been hypothesized     that sympathetic over-activity is a precursor of PE, normally compensated for by vasodilating     mechanisms, but resulting in PE when the mechanisms fail. In addition to sympathetic     activity, various markers of inflamma-tion are also associated with reduced insulin     sensitivity, suggesting that chronic sub-clinical inflamma-tion could be part of the insulin     resistance syndrome. The role of sympathetic over-activity and inflammatory markers in     gestational diabetes has not been investigated   "
230141|NCT00867035|"     Medical center personnel were screened organoleptically for bad breath by 2 investigators     using Rosenberg scale 0-5, and measurement of breath sample in portable gas chromatograph.     With a threshold score of 2 or more, or 75parts per billion(ppb) hydrogen sulfide(H2S),     subjects invited to enter clinical trial of the mechanical effect of daily tongue scraping     with the adjunctive use of 0.12% chlorhexidine gluconate mouthwash or 0.1% stabilized     chlorine dioxide mouthwash. Subjects randomly assigned in double-blind trial for one week.     The null hypothesis is there will be no difference between the two rinses as adjuncts to     tongue scraping.   "
230142|NCT00867048|"     Objectives:        -  To find out if the chance of developing a serious illness or of getting AIDS is less if          patients start taking HIV medicines at a time when their cluster-of-differentiation-4          (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at          the level where there is good evidence for starting medicines.        -  To learn more about how a strategy of starting HIV medicines early might affect other          aspects of care, such as the chances of developing other illnesses or resistance to HIV          medicines, the frequency of doctor visits, the cost of medical care, and general health          and satisfaction.   "
230143|NCT00867061|"     For MDS patients who have not responded to or have progressed after an initial response to     DNA methyltransferase inhibitors (DNMTI) and are not stem cell transplant candidates,     therapeutic options are limited. Participation in clinical trials such as this one may be     considered. The specific objectives of this trial are to find out which dose of ON 01910.Na     can be safety given to MDS patients and then find out if this dose of drug has any beneficial     effects on the patients' disease. ON 01910.Na is a new, experimental drug; the reason for     doing this trial is based on the anti-cancer activity of ON 01910.Na that has been observed     in laboratory experiments and in early clinical trials.   "
230144|NCT00867087|"     The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab     prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory     diffuse large B-cell Non-Hodgkin's lymphoma.   "
230147|NCT00867126|"     RATIONALE: Pioglitazone may slow the growth of tumor cells and may be an effective treatment     for pancreatic cancer.      PURPOSE: This phase I trial is studying how well pioglitazone works as second-line therapy in     treating patients with metastatic pancreatic cancer that progressed after treatment with     gemcitabine.   "
230148|NCT00867139|"     The purpose of this study is to assess the safety and tolerability of triple combination     antiviral drug (TCAD) for use in immunocompromised patients with Influenza A infection, and     to gain data on the effectiveness of TCAD   "
230149|NCT00867152|"     A Phase I, open label, randomized, three period, one-way, two cohort, adaptive crossover     study to evaluate the effect of darunavir/ritonavir plus etravirine and lopinavir/ritonavir     plus etravirine on GSK1349572 pharmacokinetics in healthy adult subjects   "
230150|NCT00867165|"     The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to     placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12     weeks of treatment in children >=6 to <=10 years old with primary hypercholesterolemia. The     study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B     (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The     safety of ezetimibe in this subject population will also be evaluated.   "
230151|NCT00867178|"     This pilot clinical trial studies the side effects and the best way to give vorinostat with     isotretinoin and combination chemotherapy and to see how well they work in treating younger     patients with embryonal tumors of the central nervous system. Vorinostat may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as isotretinoin, vincristine sulfate, cisplatin, cyclophosphamide, and     etoposide phosphate, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving     vorinostat with isotretinoin and combination chemotherapy may be an effective treatment for     embryonal tumors of the central nervous system. A peripheral blood stem cell transplant may     be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow     more chemotherapy to be given so that more tumor cells are killed.   "
230152|NCT00867191|"     The purpose of this study was to demonstrate the efficacy (% of change from baseline) of     desloratadine to improve the nasal total symptom score of SAR to cypress pollen.   "
230153|NCT00867204|"     This study looked at short-wire ERCP devices versus Long-wire ERCP devices. The study     hypothesis is to compare the performance of the Fusion ERCP short-wire system to the     traditional Long-wire system.   "
230154|NCT00867217|"     The primary purpose is to determine if high dose vitamin D3 reduces the incidence of     musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with     early stage breast cancer and low serum vitamin D levels. The primary hypothesis is that high     dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a     standard dose vitamin D3 treatment.   "
230155|NCT00867230|"     Primary Objective:      Determining the maximum tolerated dose (MTD) and pharmacokinetics (PK) of FTS (S-Trans,     Trans-Farnesylthiosalicylic Acid) after daily oral administration on Days 1 through 21 of a     28-Day cycle to patients with advanced hematologic malignancies that have progressed     following effective therapy or for which no effective therapy exists.   "
230156|NCT00859027|"     Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as     leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal     suppression and demonstrate increased bone turnover and consequent bone loss at the hip and     spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.   "
230157|NCT00859040|"     The purpose of this research study is to evaluate the effectiveness and safety of SOM230C in     treating recurrent meningiomas. SOM230C is a newly discovered drug that may stop meningioma     cells from growing abnormally. This drug has been used in treatment of other tumors, and     information from those other research studies suggests that SOM230C may help to stop the     growth of meningiomas.   "
230158|NCT00859053|"     The purpose of this study is to assess the effects of hepatic impairment on the single dose     pharmacokinetics of BMS-790052.   "
230159|NCT00859066|"     The purpose of this study is to quantify levels of resident anxiety under the current system     (take call alone) and compare results to a modified system.   "
230160|NCT00859079|"     The aim of the investigators study was to compare for the first time efficacy and safety of     intravenously administered GLP-1 with an established intravenous insulin regimen in     hyperglycaemic type 2 diabetic patients.   "
230161|NCT00859092|"     Swallowing dysfunction and delay of oral feeding skills in premature infants significantly     delay discharge from the hospital. Thickening oral formula or breast milk feeds with     commercial thickeners and rice cereal has been used in some nurseries with the goal of     promoting development of adequate feeding skills. The objective of this pilot study is to     examine the effect of thickened feeds on premature infants with oral feeding difficulties due     to dysfunction secondary to immature swallowing.      Hypotheses:        -  Thickened feeds will lead to a reduction in symptoms secondary to immature swallowing in          32-40 weeks gestational age infants when compared to non-thickened feeds        -  Thickened feeds will promote transition to hospital discharge.   "
230162|NCT00859105|"     Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor),     Placebo Control, Parallel Assignment, Bio-equivalence Study   "
230163|NCT00859118|"     The main purpose of this study is to see what changes happen to the tumors while taking the     axitinib and after it is stopped (during the scheduled breaks), and what changes in the tumor     may be responsible for this growth. This will be done by using a special kind of scan called     an 18F-FLT PET/CT.      In addition, the investigators want to find out how the drugs are processed and distributed     in the human body. The investigators will also look at how different types of cancer are     affected by axitinib. The investigators will also correlate vasculature kinetics extracted     from the dynamic FLT PET/CT imaging with the vasculature kinetics extracted from DCE-CT.   "
230164|NCT00859131|"     The purpose of this study is to evaluate the safety and efficacy of induction therapy with     Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).   "
230165|NCT00859144|"     This study will examine methods for involving local community members in programs to teach     urban youth about how to prevent transmission of HIV.   "
230166|NCT00859157|"     RATIONALE: New surgery techniques may lessen pain after breast surgery. It is not yet known     whether tumescent mastectomy or standard mastectomy results in less pain in women with breast     cancer.      PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain     after standard mastectomy in women with stage I, stage II, or stage III breast cancer.   "
230167|NCT00859170|"     The objectives of this post-market evaluation are        1. to assess the capacity of the procedure to be completed with use of only a semi-rigid          ureteroscope, without requiring use of a flexible ureteroscope        2. to compare the rate of retropulsion and the time required to complete the lithotripsy in          patients in which the Accordion device is used in contrast to when such a device is not          employed.   "
230168|NCT00859183|"     Despite recent advances in interventional cardiology including the success of drug-eluting     stents in de-novo coronary lesions, the treatment of in-stent restenosis remains a     challenging clinical issue. Given the efficacy of the systemic sirolimus administration to     prevent neointimal hyperplasia in animal models and to halt and even reverse the progression     of allograft vasculopathy, the aim of the present double-blind, placebo-controlled study was     to evaluate the efficacy of a 10-day oral sirolimus treatment with two different loading     regimens for the prevention of recurrent restenosis in patients with in-stent restenosis.   "
230169|NCT00859196|"     In previous in vitro studies it could be shown, that Dexpanthenol has an influence on the     gene expression of fibroblasts. The genes which are influenced by Dexpanthenol play mainly a     role during cell proliferating processes.The aim of this study is to investigate the     molecular effect of Dexpanthenol on human living skin, during wound healing.   "
230170|NCT00859209|"     The investigators hypothesize that dEtCO2 measured by the Microstream® technique via a     double-lumen ETT in infants ventilated with HFV would be feasible and adequately represent     the arterial CO2 (PaCO2).   "
230171|NCT00859222|"     The purpose of this research study is to determine the amount of LBH589 that can be given to     people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination     with bevacizumab is a drug combination that may stop cancer cells from growing abnormally.     LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA     approved for use in patients with colorectal cancer and has been studied extensively in other     types of solid tumors. The combination of LBH589 and bevacizumab has not yet been studied but     information from other studies suggests that the combination may help prevent the growth of     the participant's tumor.   "
230196|NCT00867477|"     The goal of this clinical research study is to use a new breathing test that measures the     amount of nitric oxide (NO) you exhale. Researchers want to compare your NO levels to the     amount of inflammation in your lungs, as measured using a positron emission tomography (PET)     scan reading, and with respiratory symptoms questionnaire.   "
230172|NCT00859235|"     Percutaneous endoscopic gastrostomy (PEG) is commonly used for long term enteral feeding of     patients with severe dysphagia. The most common complication is peristomal wound infection.     The possible mechanism the bacterial from the oral cavity disseminate during the PEG     insertion through the stomach to the abdominal wall, in spite the routine use of antibiotic     prophylaxis, have reported low rates of wound infection in patients who were already     receiving antibiotics at the time of PEG Our hypothesis that washing the oral cavity with     antibiotic solution prior the insertion PEG , We planned a prospective, randomised, double     blind, one centre study of antibiotic mouth wash solution (0.2% Chlorhexidine gluconate)     as.prophylaxis in PEG   "
230173|NCT00859261|"     The study purpose is to help in the developement of 3 dimensional breast ultrasound imaging.   "
230174|NCT00859274|"     It is generally accepted that symptoms and lung function are not sufficient ways to monitor     asthma control. Therefore, several objective tests have been developed to help asthma control     monitoring, each having their own shortcomings. We have developed a new test, the hypertonic     saline cough challenge. In our previous publication this test has proven useful in diagnosing     asthma. The present study is planned to investigate whether hypertonic saline cough challenge     could be used to monitor asthma control. A group of steroid-naive asthmatics will be     recruited. A treatment with inhaled budesonide is started. Asthma control is monitored at     regular intervals utilising a validated questionnaire. At the same time points, hypertonic     saline cough challenges will be performed. We will analyse whether changes in the     responsiveness to the cough challenge reflects the changes in asthma control   "
230175|NCT00859287|"     This open label, non-interventional study is to compare the efficacy of Omepral® tablet and     any other treatments excepting proton pump inhibitors (PPIs) for the treatment of various     type of acid reflux related symptoms in patients with reflux esophagitis.   "
230176|NCT00859300|"     We propose a comparative case-control study on the 2 following groups of patients:        -  Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial          infarct,        -  Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial          infarct.      The primary endpoint in this study is the correlation phenotype/genotype of sudden death at     the acute phase of myocardial infarct.      The first phase of the study, including patients' recruitment, clinical and biological data     collection, will last 82 months. The second phase will concern the genotype/phenotype     analysis and the identification of polymorphisms associated with a sudden death risk after a     myocardial infarction.      This study will allow a better knowledge of the mechanisms of sudden death and the     identification of new risk markers.   "
230177|NCT00859313|"     This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab®     PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain     medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after     undergoing knee replacement surgery.      Another goal of this study is to assess the safety and effectiveness of this non-invasive,     sublingual route of administration of ARX-F01 in decreasing the amount of pain that a patient     experiences following knee replacement surgery.   "
230178|NCT00859339|"     This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine     followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the     Bladder.   "
230224|NCT00869596|"     This study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory     mediators measured in sputum of healthy volunteers following exposure to inhaled     lipopolysaccharide.   "
230179|NCT00867243|"     The purpose of the study is to look at cells of the immune system to see if the cells are     different among people with different risk factors that have received a liver transplant. We     will enroll 50 patients receiving liver transplant and their donors. Both donor and recipient     must participate in the order for the recipient to participate in the study. We will take     blood samples from these patients and their donors.   "
230180|NCT00867269|"     Background:        -  Idiopathic CD4+ lymphocytopenia (ICL) is a condition in which there is a decreased level          of CD4+ lymphocytes (a type of white blood cell), which can lead to opportunistic          infections or autoimmune disorders and diseases.      Objectives:        -  To characterize the natural history with regard to CD4+ T cell count and onset of          infection, malignancy, and autoimmunity.        -  To describe the immunological status of patients affected by ICL while providing the          best possible standard therapy to eradicate opportunistic infections.        -  To establish the timeline of CD4 lymphocytopenia, with particular focus on defining          subgroups of patients according to the decline, stabilization, or rise of CD4+ T cell          counts over time.        -  To characterize the opportunistic infections that occur in ICL patients at microbiologic          and molecular levels.        -  To characterize the immunophenotype and possible genetic immunodeficiency causes of ICL.        -  To determine whether measurable immunologic parameters correlate with the development of          opportunistic infections or other comorbidities such as lymphoma in patients with ICL.        -  To determine whether there is any association between ICL and autoimmunity.        -  To determine CD4+ T cell turnover, survival, functionality, and cytokine responsiveness          in ICL patients.      Eligibility:        -  Patients 2 years of age and older with an absolute CD4 count less than 300 in children 6          years or older and adults or less than 20% of T cells in children younger than 6 on two          occasions at least 6 weeks apart.        -  Patients with negative results of HIV testing by ELISA, Western Blot, and viral load.        -  Patients must not have underlying immunodeficiency conditions, be receiving cytotoxic          chemotherapy (anti-cancer drugs that kill cells), or have cancer.      Design:        -  At the initial visit to the National Institutes of Health, the following evaluations          will be conducted:        -  Personal and family medical histories.        -  Physical examination, including rheumatology evaluation and other consultations as          medically indicated (e.g., dermatology, pulmonology, ophthalmology, imaging studies).        -  Blood samples for analysis of red and white blood cell counts, liver function, immune          hormones, and antibody and autoantibody levels, white blood cell growth and function,          and DNA.        -  Urinalysis and urine pregnancy testing for female patients of childbearing age.        -  Evaluation and treatment of active infections as medically indicated, including          biopsies, buccal swabs, pulmonary function tests, and imaging studies.        -  Follow-up visits will take place approximately every 12 months or more frequently if          indicated, and will continue for a minimum of 4 years and a maximum of 10 years.        -  Evaluations at follow-up will include blood samples (i.e., CBC with differential,          biochemical profile, HIV testing, etc.) and urinalysis and rheumatology consults.   "
230181|NCT00867282|"     The purpose of this study is to investigate the time course of PF-00241939 concentrations in     the blood following dosing by oral inhalation using dry powder inhalers.   "
230182|NCT00867295|"     This randomized trial is determining the role of antibiotic prophylaxis in the prevention of     the infectious complications in patients carrying out totally implantable venous access     device.   "
230183|NCT00867308|"     This is a single center open label phase II study of lenalidomide in IPSS Int-1 with     increased blasts or hematologic needs with 5q31.1 deletions who have failed to respond to     standard dose lenalidomide., IPSS Int-1 with increased blasts or hematologic needs without     5q31.1 deletions, and Int-2 and high risk myelodysplastic syndrome (MDS) patients with or     without 5q31.1 deletions, regardless of whether they have received lenalidomide previously or     not. Patients will receive two cycles of 50 mg daily lenalidomide given on days 1-28 out of a     42 day cycle. Within each of the two cycles of lenalidomide, patients will be given up to     three weeks with no drug treatment to recover. Patients who fail to respond after two cycles     of treatment may receive two additional cycles if stable. Patients who develop clinical     response may continue to receive drug until disease progression.   "
230184|NCT00867321|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib     may also stop the growth of liver cancer by blocking blood flow to the tumor.      PURPOSE: This randomized phase I/II trial is studying the best dose of bevacizumab when given     together with sorafenib as first-line therapy in treating patients with locally advanced or     metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)   "
230185|NCT00867334|"     The purpose of this study is to evaluate the safety and tolerability of imatinib mesylate in     combination with panitumumab for the treatment of stage IV colorectal cancer that has spread     to the liver. It will also assess the whether imatinib mesylate, either alone or in     combination with panitumumab, is effective in treating this type of cancer. In addition, the     study will evaluate the feasibility of a predefined lab score and whether it can predict     which patients will respond to treatment with imatinib mesylate.   "
230186|NCT00867347|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount     of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill     tumor cells. It is not yet known whether radiation therapy is more effective than surgery in     treating patients with bladder cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works compared with surgery in treating patients with bladder cancer who are receiving     chemotherapy.   "
230187|NCT00867360|"     The purpose of this research study is to see how certain hormones cause changes in mood and     thinking in some depressed patients and to determine the effectiveness of mifepristone in     treating some forms of depression.      This study is conducted in conjunction with an observational study Clinical and Biological     Characteristics of Psychotic Depression.   "
230188|NCT00867373|"     This pilot study is a randomized controlled trial with an embedded cross sectional study     exploring parental perceptions of their weight status and how it affects their perceptions of     their child's weight status. This study uses an educational intervention in which parents are     informed of their actual weight status and how it affects their child's health. We will study     the effect of this intervention on the parent's perceptions of and level of concern for their     own and their child's weight status.   "
230189|NCT00867386|"     This is an observational study for patients with type 1 diabetes, whom are already scheduled     to have desensitization treatment to help increase the chance of receiving a pancreas     transplant.The study staff will be looking at medical records in order to collect past,     present and future information for each subject's medical condition and/or transplant. There     are no additional study tests, procedures or devices needed for our analysis.   "
230190|NCT00867399|"     The objectives of this study are to assess the safety, tolerability and pharmacokinetics of     ABT-126 in elderly subjects.   "
230191|NCT00867412|"     Patients with possible operable non-small cell lung cancer are randomised to conventional     staging, or conventional staging and PET/CT. According to, patients with operable tumor will     be referred to surgery, and the number of thoracotomies and futile thoracotomies wil be     compared with the two groups in order to asses the possible benefit of PET/CT.   "
230192|NCT00867425|"     The objective of this study is to evaluate the effectiveness of Virtual Lifestyle Management     (VLM) as a behavior modification tool to promote weight loss, healthy eating and physical     activity patterns, in the interest of reducing risk and adverse outcomes for individuals at     high risk of type 2 diabetes (T2D) and cardiovascular disease (CVD) in a military population.      Specific Aim: To evaluate the effect of VLM on cardiovascular risk status in participants at     high risk or individuals with T2D enrolled in the pilot study. The investigators hypothesize     that participants will show greater improvement in weight as well as glucose, blood pressure,     lipids, and self-reported diet and physical activity than will similar patients who are not     enrolled in VLM.   "
230193|NCT00867438|"     The objective of this study is to evaluate the efficacy and the tolerability of oral     parnaparin sodium (210mg), administered in extended-release tablets identified as     CB-01-05-MMX™.   "
230194|NCT00867451|"     This study will test the efficacy of a systematic, multi-modal intervention protocol designed     to improve sleep functioning and subsequent alleviation of daytime cognitive and behavioral     difficulties among children diagnosed with ADHD. It is hypothesized that children receiving     behavioral and (if necessary) pharmacologic interventions targeting sleep will display     improvement on objective and subjective sleep measures, neuropsychological tests, and     teacher-, and parent-ratings of ADHD behaviors.   "
230195|NCT00867464|"     Background:        -  Human papillomavirus (HPV) infection is necessary for the development of cervical          cancer. Worldwide, infection with HPV types 16 and 18 accounts for approximately 70          percent of cervical cancer cases. Available data suggest that prophylactic vaccination          against HPV types 16 and 18 is nearly 100 percent effective in preventing persistent          cervical infections and resultant disease from these types for at least 5 years          following vaccination. This study is extension of a 2004 study in which 7,466 women in          Costa Rica were randomized into vaccinated and control groups. The study described here          proposes to extend follow-up of women recruited into this trial and vaccinated with the          HPV-16/18 vaccine at the start of CVT for up to an additional 6 years, for a total of up          to 10 years of follow-up. We expect to provide the HPV-16/18 vaccine to women in the          control arm of the trial after the initial 4 years of follow-up are completed, and          propose to follow them for an additional period as well. We will also enroll and follow          a new group of approximately 3000 women who will be followed with state-of-the-art          screening and will serve as an unvaccinated control group (UCG) during the extended          follow-up period.      Objectives:        -  To evaluate the 10-year global impact of HPV-16/18 vaccination of young adult women.        -  To evaluate determinants of the immune response to HPV and the vaccine and markers of          long-term protection.        -  To evaluate the natural history of HPV and cervical disease in vaccinated and          unvaccinated populations.      Eligibility:        -  Participants in the original 2004 study who lived in the Guanacaste province and few          areas of Puntarenas close to Guanacaste will be eligible for the LTFU study. Women who          received the HPV-16/18 vaccine at the start of CVT will be invited for up to 6 years of          additional follow-up, and women who were originally in the control arm of CVT and were          offered the HPV-16/18 vaccine at crossover will also be invited for additional          follow-up. Newly recruited controls (3,000) will be matched to the participants of the          original study. Women in the original study were born between July 1978 and November          1987, lived in Guanacaste or nearby Puntarenas province, and had no history of cervical          cancer or hysterectomy.      Design:        -  At enrollment, newly recruited controls will receive extensive screening and treatment          for cervical neoplasia.        -  All women (vaccinated and controls) will be followed at 2-year intervals for up to 6          years. Questionnaire data will be collected. Pelvic examinations will be performed at          each visit. Cervical secretions and cells will be collected. Women with evidence of          cervical abnormalities will have accelerated screening and will be referred to          colposcopy for evaluation and treatment if needed.        -  A subset of women will have extra clinic visits and extra blood and saliva samples          collected to allow study of the immune response to the vaccine and to the disease          itself.   "
230197|NCT00867490|"     This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ)     in patients who do not achieve controlled blood pressure levels after treatment with another     specified antihypertensive medication. There was an optional study extension for the first     eligible 60 patients who wanted to participate that contains the triple therapy with     amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.   "
230198|NCT00867503|"     The study design is a non-randomized, open label, single center Phase II trial. Eligible     patients are women who have a confirmed diagnosis of ovary, fallopian tube cancer or primary     peritoneal serous papillary carcinoma who have relapsed or are refractory to therapy after     primary treatment of their disease.      Patients will be treated with bendamustine Hydrochloride 90 mg/m2 intravenously on days 1(± 1     day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose     will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.     20 patients will be enrolled in the study.      OBJECTIVES Hypothesis/Rationale: To determine the efficacy and safety of bendamustine     hydrochloride, in women with platinum and taxane refractory ovarian cancer.   "
230199|NCT00867516|"     The purpose of this study is to determine the safety and efficacy of ALD518 in three     different doses in patients who have not had an adequate response to methotrexate.   "
230200|NCT00867529|"     This phase II trial studies giving rituximab before and after a donor peripheral blood stem     cell transplant in patients with B-cell lymphoma that does not respond to treatment     (refractory) or has come back after a period of improvement (relapsed). Monoclonal     antibodies, such as rituximab, can interfere with the ability of cancer cells to grow and     spread. Giving rituximab before and after a donor peripheral blood stem cell transplant may     help stop cancer from coming back and may help keep the patient's immune system from     rejecting the donor's stem cells.   "
230201|NCT00867542|"     oral status and early childhood caries (ecc) in israeli children with past IUGR   "
230202|NCT00867555|"     The body of evidence regarding the health benefits of green tea has grown considerably during     the last decade and includes antioxidant properties, anti- cancer, anti-obesity and     anti-diabetes effects. There has been evidence that green tea extract favorably affect body     weight and body fat and has positive effects on blood glucose control      Aim of this study is to investigate the short term effect (3-day)of TEAVIGO (high in the     catechin EGCG) on postprandial fat oxidation during different phases of the postprandial     period in overweight subjects. Secondly, in a subset of volunteers changes in lipolysis and     glucose metabolism will be studied in skeletal muscle and adipose tissue.   "
230236|NCT00869752|"     RATIONALE: Monoclonal antibodies, such as MK-0646, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing.      PURPOSE: This phase I/II trial is studying the side effects and best dose of MK-0646 when     given together with etoposide and cisplatin and to see how well it works in treating patients     with extensive-stage small cell lung cancer.   "
230203|NCT00867568|"     The purpose of this research study is to evaluate a new investigational drug (TPI 287) for     neuroblastoma and medulloblastoma both alone and in combination with temozolomide (a     currently approved drug). An investigational drug is one that has not yet been approved by     the Food and Drug Administration. This investigational drug is called TPI 287. This study     will look at the safety and tolerability of TPI 287 both alone and in combination with     temozolomide, and look to establish a safe dose of this agent. The study will also look at     the tumor's response to these drugs, but this is not the primary objective of this study.      TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in     three different animal species. TPI 287 has been tested in humans in four clinical trials,     and approximately 100 subjects with various types of cancers have received the drug. All of     these subjects that have received TPI 287 have been adults. TPI 287 has not been tested in a     pediatric population before this study.      Temozolomide was tested in recurrent neuroblastoma and showed activity in a recently     published study. Preclinical studies of TPI in combination with temozolomide have shown at     minimum an additive effect. The ability of temozolomide and TPI 287 to be effective in     combination is suggested by these two drugs showing even greater activity when used together.   "
230204|NCT00869336|"     To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or     28 days to achieve complete clearance at 2 weeks post treatment.   "
230205|NCT00869349|"     The purpose of the Living Well with RA program is to perform a proof-of-concept study and     evaluate the efficacy of an Internal Family Systems-based psychotherapeutic intervention     improve Rheumatoid Arthritis subjects' disease activity, independence and other health     outcomes. This study will also assess the efficacy of an IFS-based program in improving RA     subjects' mental health symptoms. We hypothesize that the IFS model will improve RA subjects     self-management of their disease and subsequently their health outcomes will improve as well     as compared to a group focusing on arthritis education.   "
230206|NCT00869362|"     The hypothesis of this study is that using hospital admission to identify patients with     poorly controlled diabetes (hemoglobin A1c levels >8%), and intervening during the     hospitalization with targeted inpatient diabetes management will improve glycemic control at     3 and 12 months, with inpatient glycemic control, quality of life, and diabetes self-efficacy     serving as secondary endpoints.   "
230207|NCT00869375|"     The purpose of this study is to compare the effects (positive and negative) of two different     devices available to treat people with critical limb ischemia, which involves a sudden     decrease in blood flow to the leg that causes a potential threat to the limb and causes pain     at rest, ulcers or gangrene.      One device is the Clearway balloon, which delivers a drug to dissolve the clot where the     blockage is. The other device is the Angiojet, which removes the clot in a mechanical way     (vacuum effect). This research is being done because currently there is no single proven     effective treatment for this condition. Even though, both these devices are commonly used in     the clinical practice to treat critical limb ischemia, there are no studies that compare     these devices and help us see which one may be better for these patients.   "
230208|NCT00869388|"     This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly     to patients with solid tumors.   "
230209|NCT00869401|"     Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. It may also make tumor cells more sensitive to radiation therapy. Radiation therapy     uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. This randomized phase I/II trial is studying the     best dose of dasatinib and to see how well it works compared with a placebo when given     together with radiation therapy and temozolomide in treating patients with newly diagnosed     glioblastoma multiforme.   "
230210|NCT00869414|"     This research is a prospective, randomized, cross-over study that is being done to compare     the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on     hypoglycemia (blood glucose level <70 mg/dL) as measured by continuous glucose monitoring     (CGM) in patients with type 1 diabetes.   "
230211|NCT00869427|"     After spinal cord injury, patients have frequent urinary tract infections (UVI). Vitamin C is     usually prescribed to prevent such infection, but the efficacy of the treatment is poorly     documented. In the study, patients will be randomised either to receive vitamin C daily, or     not, for one year, and clinical episodes of UVI will be registered. The null hypothesis is     that vitamin C will not reduce the number of UVI episodes by 30%.   "
230212|NCT00869440|"     The purpose of this study is to assess the safety and efficacy of CNS 7056 as a procedural     sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.   "
230213|NCT00869453|"     The role of gut hormone (GLP-1, GIP, PYY...) in glucose homeostasis has been widely     demonstrated. Furthermore modifications in their pattern of secretion seem to be involved in     the improvement of glucose control in obese patients after bariatric surgery.      The purpose of this study is to assess the respective role of carbohydrate, fat and protein     from a complete meal in gut hormones secretion.   "
230214|NCT00869466|"     RATIONALE: Measuring changes in body weight and body composition in women with early-stage     breast cancer may help doctors plan the best weight control program and improve patients'     quality of life. It is not yet known which program is most effective in women with breast     cancer.      PURPOSE: This randomized clinical trial is comparing three weight control programs to see how     well they work in women who have undergone surgery for early stage breast cancer.   "
230215|NCT00869479|"     The Primary Aim of this study is to validate a questionnaire as a screening tool to identify     subjects with symptoms suggestive of nephrogenic systemic fibrosis (NSF). The investigators     believe that there will be difference between subjects with NSF and other skin conditions and     normal skin.   "
230216|NCT00869492|"     The purpose of this study is to determine whether using of nadifloxacine 1% cream and benzoyl     peroxide 5% solution together is more effective than using nadifloxacine alone in the     treatment of mild to moderate facial acne.   "
230266|NCT00870155|"     To obtain additional safety data in subjects who have previously completed the MBP8298-01     study A Double Blind Placebo Controlled Multi-Centre to Evaluate the Efficacy and Safety of     MBP8298 in Subjects with Secondary Multiple Sclerosis Dirucotide is generic name for     MBP8298.   "
230217|NCT00869505|"     Memantine is a glutamate receptor antagonist that has been reported to reduce     Obsessive-Compulsive Disorder (OCD) symptoms in case studies of treatment-resistant     individuals. The investigators hypothesized that memantine is an effective augmenting agent     to standard intensive residential treatment of severe OCD. An intent-to-treat,     single-blinded, naturalistic case-control design is employed. The sample includes subjects     receiving standard treatment at the McLean/ MGH Intensive Residential Treatment (IRT)     program, half of whom also receive memantine augmentation. Admission, monthly and discharge     measures of OCD, depression and psychosocial functioning are collected by raters blinded to     augmentation status. Matched controls are selected based upon gender, initial OCD severity,     psychosocial functioning, and timing of admission. Descriptive and comparative analyses are     conducted via SPSS, statistical significance is defined at p<0.05, clinically significant     response is defined by a 25% reduction, and 'marked response' is defined by a 50% improvement     in Yale-Brown Obsessive Compulsive severity (Y-BOCS) scores, using a     last-observation-carried-forward approach. The Clinical Global Improvement (CGI) scale     captures global clinical change.   "
230218|NCT00869518|"     DESIGN: This single center, double-blinded, randomized phase II study is being conducted to     assess the efficacy of a rifabutin based regimen to eliminate S. aureus colonization in HIV     infected individuals. Individuals must have HIV infection and a skin and skin structure     infection (SSSI) in the prior 6 months to be eligible for screening. Prior to enrollment,     subjects will be cultured for evidence of S. aureus colonization. Individuals who are culture     positive at ≥ one body site will be eligible for enrollment. Subjects who meet inclusion and     exclusion criteria and consent to participate in the study will be randomized to seven days     of rifabutin plus trimethoprim-sulfamethoxazole (TMP-SMX) or TMP-SMX alone. Following     completion of treatment subjects will be screened seven days, 30 days, and 60 days     post-treatment for colonization at multiple body-sites. Subjects will also be actively     followed for evidence of SSSI.      SUBJECT PARTICIPATION DURATION: 12 weeks      SAMPLE SIZE: 88 total subjects      POPULATION: 200 HIV infected individuals who receive care at San Francisco General Hospital     HIV clinic (Ward 86) with a history of SSSI in the prior 6 months will be screened for S.     aureus colonization.      DESCRIPTION OF AGENT OR INTERVENTION: This is a double-blind trial comparing rifabutin plus     TMP-SMX versus placebo plus TMP-SMX. Placebo will be administered at a dose of 300 mg p.o.     daily or an equivalent dose depending on co-administration of other drugs that may adjust the     serum level of rifabutin. TMP-SMX will be administered at a dose of trimethoprim 160 mg and     sulfamethoxazole 800 mg p.o. twice daily or adjusted per CrCl. Study drug will be provided by     the study and administered for 7 days.   "
230219|NCT00869531|"     The aim of this study is to investigate the potential beneficial effect of wholegrain on body     weight and composition as well as cardiovascular risk in overweight women.   "
230220|NCT00869544|"     A. Statement of Hypotheses:      HIV-infected patients have an increased incidence of emphysema compared to non-HIV-infected     smokers, and it has been hypothesized that this accelerated disease progression is the result     of one or more latent infections that amplifies the pulmonary inflammatory response to     cigarette smoke. Pneumocystis is one infectious agent that likely plays a key role in the     development of HIV-associated emphysema. Colonization with Pneumocystis has been demonstrated     in HIV-infected subjects, and HIV-infected smokers are particularly susceptible to Pc     colonization regardless of CD4 cell count or use of prophylaxis. Pneumocystis colonization is     also increased in non-HIV-infected patients with chronic obstructive pulmonary disease (COPD)     and is directly related to the severity of the disease. The presence of Pneumocystis in the     lungs, even at low levels as seen in colonization, produces inflammatory changes similar to     those seen in COPD, with increases in the numbers of neutrophils and cytotoxic CD8+     lymphocytes. We propose that Pneumocystis accelerates emphysema in HIV-infected smokers by     stimulating inflammation and tissue destruction. We will examine the role of co-infection     with Pneumocystis in the pathogenesis of HIV-associated emphysema and the mechanism by which     it causes emphysema progression. These studies will lead to information that will provide a     rational basis for prevention and therapy of HIV-associated emphysema and provide a model for     emphysema in the general population   "
230221|NCT00869557|"     The objective of this double-blinded, multicenter, randomized, active-controlled study is to     evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed     doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir     disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected,     antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for     patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs.      Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization     will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at     screening. After Week 48, participants will continue to take their blinded study drug and     attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which     point all participants will attend an Unblinding Visit and be given the option to participate     in an open-label rollover extension (the extension is scheduled to be open until Stribild     becomes commercially available, or until Gilead Sciences elects to terminate the study).   "
230222|NCT00869570|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood     flow to the tumor. Giving radiation therapy together with capecitabine and sorafenib before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed.      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine     when given together with sorafenib and external-beam radiation therapy and to see how well it     works in treating patients with locally advanced rectal cancer.   "
230223|NCT00869583|"     Obesity is a serious health problem among Mexican American women. Obesity combined with a     lack of physical activity can increase the risk for several diseases, including heart     disease. This study will evaluate a program that aims to increase physical activity levels     among women of Mexican origin in Columbia, South Carolina and the Lower Rio Grande Valley of     Texas.   "
230225|NCT00869609|"     Heart disease is a leading cause of death in people in the United States. It is a major     problem for those with diabetes. Conditions called the metabolic syndrome and pre-diabetes     increase risk for diabetes and heart disease. The metabolic syndrome is a group of disorders     that occur at the same time. Overall, one in four American adults has the metabolic syndrome.     It is more common in people over the age of 40. The metabolic syndrome includes: 1) large     waist size, 2) high triglycerides, 3) low HDL cholesterol, 4) high blood pressure and 5) high     fasting blood sugar. People with the metabolic syndrome have at least three of these five     risk factors. Pre-diabetes is considered to be present in those with high fasting blood sugar     levels below the diabetes range.      Research has shown that type 2 diabetes and the metabolic syndrome may be prevented or     delayed by making lifestyle changes. It is not known what will most help people continue     these healthy changes over time. The purpose of this study is to look at ways to help people     continue the healthy lifestyle changes they have made while taking part in a diabetes     prevention program called Group Lifestyle Balance (GLB).   "
230226|NCT00869622|"     Study Design: (e.g., Controlled, Double-Blind, Randomized, Parallel):      Randomized, double-blind, placebo controlled of a bisphosphonate in the prevention of bone     loss associated with the use of antiepileptic drugs.   "
230227|NCT00869635|"     In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary     stent has been known for palliation of jaundice and improving survival. But most of     therapeutic effects were expected to delay bile duct obstruction rather than to decrease the     tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in     patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the     combined effect of photodynamic therapy and S-1.   "
230228|NCT00869648|"     Ventilation during basic life support improves survival in cardiac arrest patients     significantly. Unfortunately, this is in contrast to the willingness of potential rescuers to     perform mouth-to-mouth ventilation. For example, although healthcare professionals would     perform mouth-to-mouth ventilation on a 4-year old drowned child in >90% of cases, this     likelihood would decrease to ~10% in the case of a young male unconscious patient in a San     Francisco public bus. Possibly, lay rescuers would perform assisted ventilation more often if     a simple ventilation device were available. However, both the willingness to perform assisted     ventilation plus the ability to open and to maintain the airway patent are necessary to     ensure efficient ventilation in an unconscious patient with an unprotected upper airway.      Since retention of skills after basic life support classes are notoriously low, a     resuscitation tool should incorporate self-explanatory features to improve applicability, and     to provide built-in safety. Thus, an option could be to ensure an open airway by the use of a     built-in indicator within a ventilating device to confirm correct head extension. One     possible approach may be to determine head position angles that make an open airway likely,     and integrate these angles into a scale on a ventilating device; however, safe head extension     needs to be determined first to prevent harm.      The purpose of this study is to determine head position angles and ventilation parameters     reflecting neutral position, maximal extension and a position deemed optimal by an     anaesthesiologist in patients undergoing anaesthesia induction for elective surgery in a     first step to design a ventilating device to optimise ventilation of an unprotected upper     airway. The investigators will ventilate 30 patients with a pillow under the head simulating     ventilation in the operating theater, and 30 patients without a pillow under the head     simulating ventilation during cardiopulmonary resuscitation.      Dentures will not be removed during assessment. After anaesthesia induction the head will be     consecutively flexed in the three positions and measurements performed. Afterwards, general     anaesthesia and surgery will ensue. The health risk for this extra minutes of mask     ventilation is minimal.      The null hypothesis is that there will be no differences in head position angles and     ventilation parameters.   "
230229|NCT00869661|"     This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with     the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily)     (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The     first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed     by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC     for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for     12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response     will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4     will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36     weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an     open-label basis for patients of Group 5 who failed treatment. Patients will receive     RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The     anticipated time on study treatment is 6-12 months.   "
230230|NCT00869674|"     The primary objective of this trial is to compare GeneSearch™ Breast Lymph Node (BLN) Test     Kit to permanent pathological section, so as to evaluate the clinical sensitivity and     specificity of GeneSearch™ Breast Lymph Node (BLN) Test Kit in detecting axillary sentinel     lymph node metastases in breast cancer patients.      The secondary objective of this trial is to evaluate the positive predictive value and     negative predictive value of GeneSearch™ Breast Lymph Node (BLN) Test Kit when used in the     detection of axillary sentinel lymph node metastases in breast cancer patients.      Prospective and multi-center clinical trial   "
230231|NCT00869687|"     The primary objective of this study involves research to evaluate new collagen (the elastic     fibers that provide skin with its strength and resilience) formation in the skin following     injections of Sculptra (Poly-L-Lactic Acid or PLLA). The secondary objectives of the study     are to better understand the human skin responses to Sculptra and to assess the safety of     Sculptra injections.   "
230232|NCT00869700|"     Despite the clinical significance of potential interactions between antimalarials and     antiretrovirals, no drug interaction studies have been published and there is an urgent need     to address this gap in current knowledge.      The aim of the study is to investigate the pharmacokinetics (PK) of antimalarial combination     artemether/lumefantrine (AL) and combination antiretroviral therapy (cART) including     lopinavir/ritonavir (LPV/r) in HIV-infected adults.   "
230233|NCT00869713|"     This study is designed to determine the safety and immunogenicity of an inactivated Rift     Valley Fever (RVF) Vaccine in adults   "
230234|NCT00869726|"     The purpose of this study is to determine whether MBP8298 is effective and safe in the     treatment secondary progressive multiple sclerosis.      Dirucotide is generic name for MBP8298.   "
230235|NCT00869739|"     RATIONALE: Telephone counseling after radical prostatectomy may help African American     prostate cancer survivors and their intimate partners cope with the problems and challenges     of surgery, and may reduce distress and improve quality of life. It is not yet known which     counseling and education program is more effective in helping prostate cancer survivors and     their partners.      PURPOSE: This randomized clinical trial is studying effective ways to help African American     prostate cancer survivors and their partners cope with challenges after surgery for     early-stage prostate cancer.   "
230237|NCT00869765|"     Among antidepressant treatments, Electroconvulsive therapy (ECT) stands as the most effective     in treating acute depression. However, patient concerns with the cognitive side effects of     ECT have encouraged the development of new and more focal forms of brain stimulation such as     transcranial Direct Current Stimulation (tDCS). The investigators' current study of tDCS as a     treatment for depression suggests that this technique has antidepressant effects and is safe,     painless and well tolerated. However, not all patients may respond to this treatment and the     concern of possible relapse in some patients who respond to tDCS has raised interest in     finding treatments that may enhance and prolong the antidepressant effects of tDCS. This     study will investigate whether D-Cycloserine, a medication shown to lengthen the effects of     tDCS on brain activity, can also enhance/prolong the antidepressant effects of tDCS in people     suffering from depression.   "
230238|NCT00869778|"     The purpose is to evaluate efficacy and safety of therapeutic Hepatitis B Virus（HBV） vaccine     (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective     dosage and provide the rational for optimal dosing schedule.   "
230239|NCT00869791|"     This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066     compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced     Parkinson's disease.   "
230240|NCT00869804|"     Chemotherapy for the treatment of breast cancer can affect nerves and muscles leading to loss     of sensation in the hands and feet for feeling hot and cold, difficulty walking, and muscle     weakness. This study will explore if exercises such as walking and strength training may     prove helpful in preventing or lessening chemotherapy-induced peripheral neuropathy from     chemotherapy, making the therapy easier to tolerate and increasing overall quality of life.   "
230241|NCT00869817|"     The purpose of this study is to identify potential biomarkers that may predict the     development of Alzheimer's disease in people who carry an Alzheimer's mutation.   "
230242|NCT00869830|"     The aims of the investigators' study are to characterize the nature of constipation in     idiopathic Parkinson's disease (IPD) and to evaluate the usefulness of biofeedback therapy in     constipated IPD patients.   "
230243|NCT00869843|"     -  To determine the depth of coagulation which is possible in human liver tissue using the          saline linked RF Surface ablation with the Tissue Link floating ball.        -  To determine the efficacy of the technique on surface liver tumors using saline linked          RF surface ablati        -  To determine a safe (non-popping upper limit) of power per area that will permit a 1 cm          depth of tissue destruction without inflow occlusion an da 2 cm depth with inflow          occlusion.   "
230244|NCT00869856|"     This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety     switch study involving 500 CKD subjects suffering from anemia and treated previously with a     stable dose of ESA s.c.      Correction of anemia will be maintained by s.c. administration of HX575 in two frequencies     (i.e. qw and q2w), in order to maintain an Hb target range of 10.0-12.0 g/dL.   "
230245|NCT00869869|"     The purpose of this study is to determine whether melatonin can improve sleep, quality of     life and markers of heart failure in patients with heart failure.   "
230246|NCT00869882|"     This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical     treatment at one level, aimed at comparing two approaches of spinal fusion.   "
230247|NCT00869895|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of E7050 given     orally in patients with advanced solid tumors.   "
230248|NCT00869908|"     This study is conducted in Africa, Asia, South America and Europe. The aim of this     observational study is to document the experience with the study insulins when used in     routine clinical practice. After the physician's decision to start insulin treatment using     NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to     be included in this study at the physician's discretion   "
230249|NCT00869921|"     Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of     lead-related complications occuring during the study compared to the number of leads enrolled     in the study. The leads will be followed for 5 years after implant. This study is required by     FDA as a condition of approval of the Model 4195 LV Lead and is integrated within Medtronic's     post-market surveillance platform.   "
230250|NCT00869934|"     Insomnia is a prevalent public health problem affecting large segments of the population on     an occasional, recurrent, or chronic basis. Persistent insomnia is associated with     impairments in daytime functioning, reduced quality of life, and increased health-care costs.     Despite evidence that cognitive-behavior therapy (CBT) is an effective and well accepted     treatment for insomnia, a significant proportion of individuals do not respond adequately to     this treatment. Hence, there is a need to identify the active therapy components and     mechanisms of change in order to develop more effective therapeutic approaches and optimize     outcomes. The specific aims of the proposed study are to (a) evaluate the effects of     behavioral versus cognitive therapies for insomnia and associated daytime impairment, (b)     investigate the mechanisms of change and, (c) examine the impact of insomnia therapies on     psychiatric conditions commonly associated with insomnia (anxiety disorders and depression).     A sample of 186 adults with chronic insomnia will be recruited from two sites (Laval     University and University of California, Berkeley). Participants will be randomly assigned to     one of three groups: (a) behavior therapy (BT; n = 62), (b) cognitive therapy (CT; n = 62),     or (c) cognitive-behavior therapy (CBT; n = 62). Measures of outcome (sleep/insomnia, daytime     functioning) will be administered at baseline, end of treatment, and at 6- and 12-month     follow up. Measures of mechanisms of change (maladaptive sleep habits, unhelpful beliefs,     sleep-related worry) will be administered at baseline, after the 4th and 8th therapy     sessions, and at the end of treatment. It is expected that (1) BT and CBT will be more     effective for improving sleep, relative to CT, (2) CT and CBT will be more effective for     reducing daytime functional impairment, relative to BT and (3)CT will be more effective than     BT in reducing comorbid psychiatric disorders. The public health significance of the proposed     study is that it will provide useful information to improve our understanding of insomnia and     to enhance efficacy and efficiency of therapeutic approaches for a prevalent and costly     health problem. The long-term objective is to contribute to the development and dissemination     of evidence-based treatments for chronic insomnia and its common comorbidities.   "
230263|NCT00870116|"     The purpose of this study is to evaluate local disease control after 2 years in patients with     non-metastatic, non-operated non-small-cell lung cancer treated by radiotherapy.      Eligible patients will be recruited and registered consecutively (no randomization). The     estimated inclusion period is approximately 24 months. The duration of the research is 4     years.      The number of patients required in this multicentric prospective study is 120:        -  20 patients in the SBRT-1 arm (cyberknife),        -  80 patients in the SBRT-2 arm (linear accelerator-based)        -  20 patients in the conformational radiotherapy arm.      This is a prospective, multicentric, non comparative and non randomized study.   "
230377|NCT00871624|"     The purpose of the study is to determine the efficacy and safety of dexmedetomidine during     Non-invasive positive pressure ventilation (NPPV) for patients with acute respiratory failure     compared to standard analgesic/sedation practices   "
230251|NCT00869947|"     Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at     the same speeds as non-amputees and this discrepancy is more apparent at faster walking     speeds. Amputees choose to walk at speeds 30-40% slower than non-amputees. Preferred walking     speed is likely influenced by elevated metabolic energy, but the underlying reason for slower     preferred walking speeds is not fully understood. Unilateral amputees exhibit highly     asymmetrical gait patterns that likely require more metabolic energy and impair functional     mobility, increasing the risk of degenerative joint disease, osteo-arthritis and lower back     pain. Improvements in prosthetic devices could enhance mobility in amputees, thus positively     effecting rehabilitation and ambulation in veterans. A prosthesis that allows amputees to     reduce metabolic energy would be especially useful for rehabilitation in older, ill     individuals with reduced exercise capacities and could literally restore walking ability in     people that are currently non-ambulatory.      Hypotheses. Amputees wearing the Massachusetts Institute of Technology (MIT) Powered     Ankle-Foot (PAF) prosthesis will have a lower metabolic cost, faster preferred walking speed,     and improved gait symmetry during walking than amputees wearing a conventional prosthesis and     will have nearly the same metabolic cost, preferred walking speed, and gait symmetry during     walking as age, gender, height, and weight matched non-amputees.   "
230252|NCT00869960|"     Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher     amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The     reason for this higher drug exposure has not been determined. The primary purpose of this     study is to examine whether the pharmacokinetics (factors that determine the amount of drug     in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women     and ultimately result in higher amounts of drug in the body compared with men. In other     words, we plan to examine whether changes in sex hormones throughout the menstrual cycle     affect the amount of anti-HIV drugs in women. The antiretroviral drugs atazanavir, ritonavir,     tenofovir and emtricitabine will be studied. This study will be conducted in healthy women     since HIV may change the pharmacokinetics of anti-HIV drugs.   "
230253|NCT00869973|"     The aim of the study is to compare efficacy and tolerability of aprepitant versus     dexamethasone in the prevention of delayed emesis induced by moderately emetogenic     chemotherapy (cyclophosphamide plus anthracyclines) in breast cancer patients.   "
230254|NCT00869986|"     The purpose of this study is to test if dirucotide is safe and effective in treating patients     with relapsing remitting multiple sclerosis.   "
230255|NCT00869999|"     Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in     diffuse large B-cell lymphoma (DLBCL) in both preclinical and clinical studies. The purpose     of this research study is to determine whether Everolimus plus rituximab is safe and     effective in participants with relapsed or refractory DLBCL. Everolimus is an investigational     drug that works by blocking a special protein that helps cancer cells grow. The safety and     effectiveness of Everolimus in the treatment of DLBCL has not yet been fully determined and     is still investigational. The other drug in this study, rituximab, is approved by the US Food     and Drug Administration (FDA) for use in patients who have diffuse large B-cell lymphoma and     certain other types of non-Hodgkin lymphoma. Rituximab is a drug that destroys both normal     and cancerous B-cells.   "
230256|NCT00870012|"     The investigators' aim is to determine whether probiotic and prebiotic treatment plus     lifestyle advice is more effective in reducing hepatic fat content than lifestyle advice     alone in patients with Nonalcoholic Fatty Liver Disease (NAFLD).   "
230257|NCT00870025|"     There is a decline in androgen concentration with ovarian aging. Also, ovarian response to     COH in IVF cycles diminishes with ovarian aging. Recent evidence suggest that testosterone or     DHEA may improve ovarian response in poor prognosis patients by increasing intraovarian     androgen concentration. A physiological way to induce androgen synthesis within the ovary is     to stimulate theca cells androgen production by hCG stimulation. By doing this in the     previous cycle we might expect a better response to COH.   "
230258|NCT00870038|"     The investigators sought to discover which one of the following strategies is the safest for     patients undergoing percutaneous coronary intervention: paclitaxel-coated balloon+Genous     stent; Genous stent; drug eluting stent (paclitaxel).   "
230259|NCT00870051|"     The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant     Stent Graft System from AAA subjects.   "
230260|NCT00870064|"     Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a     formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the     wound is irrigated. While this is the current standard of care, not all open fractures are     equal. In retrospective studies, centers are reporting less aggressive operative management     for open fractures may result in equal results without the time and expense of the operative     theater. The investigators propose a prospective, randomized trial of children with type I     open fractures to evaluate whether formal operative treatment is necessary. The     investigators' hypothesis is that minor open fractures can be safely treated in the emergency     room with irrigation, closed reduction and home antibiotics without an increased risk of     infection or other complications. Children who meet the study criteria will be randomized     into two treatment arms - formal operative management (OR) and emergency department (ED)     management. Outcomes from each group will be evaluated and compared, including rate of     infection, number of return visits to the operating room, time to union, and other     complications.   "
230261|NCT00870077|"     An increase in dietary protein intake has been shown to blunt the increase in intrahepatic     fat induced by high fat feeding in healthy individuals. The purpose of this study is to     determine if a protein supplementation decreases intrahepatic fat in obese patients with     non-alcoholic fatty liver disease.   "
230262|NCT00870103|"     To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is     effective and safe for the prevention of postoperative inflammation as a consequence of     cataract extraction surgery.   "
230264|NCT00870129|"     The purpose of this study is to assess the ability of these advanced MRI scans in predicting     areas within a malignant glioma (brain tumor) that are at a high risk of recurring. If these     advanced MRI scans are able to identify the cancerous part of the tumor, then radiation     therapy can be targeted to those sites and possibly improve patient survival.   "
230267|NCT00870168|"     RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line     chemotherapy for metastatic breast cancer.   "
230268|NCT00870181|"     Malignant gliomas are the most common primary brain tumor in adults, but the prognosis for     patients with these tumors remains poor despite advances in diagnosis and standard therapies     such as surgery, radiation therapy, and chemotherapy. The advantages of ADV-TK gene therapy     highlight its efficacy and safety for glioma patients. This clinical trial was conducted to     assess the anti-tumor efficacy and safety of intraarterial cerebral infusion of     replication-deficient adenovirus mutant ADV-TK, in combination with systemic intravenous GCV     administration in patients with recurrent high-grade glioma.   "
230269|NCT00870194|"     The purpose of this study is to determine whether ceasing sitagliptin and switching to     exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in     those patients with type 2 diabetes who are experiencing inadequate glycemic control with a     combination of sitagliptin and metformin.   "
230270|NCT00870207|"     Building on existing intervention strategies of the Tu Salud Si Cuenta media campaign, this     proposed worksite pilot study will be testing a new feature by designing worksite promotion     intervention strategies. The purpose of this study is to test the feasibility of a     worksite-based physical activity and healthful food choice. The intervention will be among     two worksites in the Lower Rio Grande Valley who employ primarily Mexican-American personnel.   "
230271|NCT00870220|"     This is a multicenter, randomized, controlled, semi-blinded study to compare two low doses of     estradiol administered by recently available transdermal patches for the initiation of     puberty in Turner syndrome girls 11.5-13.0 years old in conjunction with growth hormone (GH)     therapy.      The specific hypotheses to be tested are: when combined with growth hormone (GH) treatment,     low dose transdermal estradiol (LTE2) replacement will be more effective in stimulating     feminization, height velocity, and bone mineral density without compromising growth potential     than very low dose transdermal estradiol (VLTE2), which will in turn be superior to GH alone     in effects on feminization, height velocity, and bone mineral density.   "
230272|NCT00870233|"     This study is being done to see if most patients are willing and able to report how they are     feeling after surgery using the internet, and if this information can help doctors and nurses     detect concerning symptoms after surgery.      This study uses a special new website called WEBCORE. Patients can logon to WEBCORE and     answer questions about how they are feeling. Then, doctors and nurses can look at this     information during clinic appointments. We are doing this study to see if WEBCORE is a     helpful way for us to keep track of information about how patients are feeling and quality of     life. If WEBCORE is helpful, we will use it in the future to collect more information about     patients' symptoms and quality of life. We can use what we learn to help find better ways of     helping patients to prepare for what they will go through while they recover from surgery.   "
230273|NCT00870246|"     The purpose of this study is to evaluate the influence of diaphragm mobility on exercise     capacity and dyspnoea in patients with chronic obstructive pulmonary disease (COPD).   "
230275|NCT00870272|"     This open-label, randomized study is being conducted to determine whether a dose of 400 mcg     of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of     mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with     misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination     of intrauterine pregnancy with gestational ages of <63 days will be offered the option of     participating in the study.   "
230276|NCT00870285|"     Ustekinumab, an IL-12/23 antibody has been approved in the E.C. and U.S.A. for the treatment     of moderate to severe psoriasis. The aim of this study is to determine in a randomized     half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and     improves the clearance of skin lesions in Ustekinumab-treated patients.   "
230277|NCT00870298|"     To determine if a computerized stop order will reduce the number of concurrent     trimethoprim/sulfamethoxazole and warfarin orders accepted through the inpatient electronic     ordering system while a patient is hospitalized.   "
230278|NCT00870311|"     This study investigates the effects of Lithium treatment on signal transduction pathways,     gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It     is hypothesized that specific changes in these markers will correlate with lithium treatment     responsiveness.   "
230279|NCT00870324|"     The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine     episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave     (FFRW). The performance of the lead will be measured as a difference in device-determined     time in AT/AF and surface-ECG determined time in AT/AF. This measurement will be compared to     the control group which will be randomized to receive SJM's Tendril™ RA leads.   "
230280|NCT00870337|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with     relapsed or metastatic endometrial cancer.   "
230281|NCT00870350|"     Open-label, randomized, multi-centre study in which 400 subjects, divided into two groups,     will receive Td5ap or Td1aP as a single injection. We will then describe the immune response     and safety profile of the combined vaccine booster.   "
230306|NCT00870688|"     Valproate is the first line therapy in primary generalized seizures. The applied drug     contains sodium valproate in sustained release minitablets. As a multiple unit dosage form     these can be easily swallowed and taken independent from meals.      A simple dosage scheme like valproate sustained release minitablets once daily in the evening     should improve the compliance and likely the seizure situation of the patients. The data of     this non interventional trial were directly extracted from the physician's electronic patient     database. The observational period was 7 weeks compared to a retrospective period 7 weeks     before start of the study.   "
230345|NCT00871195|"     The objective of this study is to evaluate the performance of Sequenom's noninvasive test for     fetal RHD genotype. The test uses MALDI-TOF mass spectrometry to detect DNA. The study is     specifically designed to determine whether RHD typing using free fetal DNA in maternal     circulation can accurately predict the neonatal RhD phenotype at birth.   "
230282|NCT00870363|"     This research study is being done to find out how the immune system in the small intestines     improves after taking antiretroviral (anti-HIV) medications. Biopsies (small snips of tissue)     will be taken from the part of the intestines just below the stomach, and will be studied in     the laboratory. The main purpose of this study is to measure the increase in the numbers of     immune cells in the intestines to see if this number is related to the amount of medication     that reaches the intestinal tissue, and the amount of virus that is still hiding there.      Subjects are either normal control subjects without HIV or, are HIV positive and are about to     start HIV medications. As part of this study, HIV positive patients will be randomized to     receive one of three possible combinations of medications.        1. maraviroc (Selzentry) in combination with 2 NRTIs (dual nucleoside reverse transcriptase          inhibitor) or        2. maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse          transcriptase inhibitor) or        3. efavirenz (Sustiva) in combination with 2 NRTIs (dual nucleoside reverse transcriptase          inhibitor)      Both Maraviroc and Raltegravir each represent new classes of medications in the way that they     interfere with HIV making copies of itself. Maraviroc attaches to the surface of the T-cell     that the virus uses to get into the cell and is therefore known as an entry inhibitor.     Raltegravir blocks the virus from inserting itself into the DNA of the infected cell's     nucleus and is therefore known as an Integrase Inhibitor. We hope to learn more about how     antiretroviral drugs affect T cells and how immune function restores itself when HIV     infection is treated.   "
230283|NCT00870376|"     Urodynamic study is an objective method to evaluate female patients with lower urinary tract     symptoms (LUTS). However, this method includes place a urinary catheter, thus prevents it as     a routine method to evaluate and follow up patients with LUTS. Therefore, it is necessary to     find a simple and objective method to help in evaluating female patients with LUTS. Several     kinds of biomarker had been reported in diagnosing patients with overactive bladder; however,     the sensitivity remained poor. The aim of this study is to find a useful biomarker,     biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely     in evaluating the female patients with LUTS.   "
230284|NCT00870402|"     The purpose of this study is to determine whether spironolactone are effective in the     reduction of albuminuria and diastolic disfunction of subjects with diabetic nephropathy.   "
230285|NCT00870415|"     RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and     may have fewer side effects and improve recovery.      PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in     treating women with breast cancer.   "
230286|NCT00870428|"     The investigators intend to perform a large prospective study looking at the predictability     of the random urine protein-to-creatinine ratio compared to the gold standard 24-hour urine     protein collection. Furthermore, the investigators plan to investigate whether analysis of     proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-hour collection     period is predictive of the 24-hour sample. Lastly, the investigators plan to determine     whether a combination of the random test with a shorter collection interval is comparable to     the 24-hour collection.   "
230287|NCT00870441|"     The objective of the study is to compare the safety of ASP2151 to valacyclovir and placebo in     healthy male and female adult volunteers.   "
230288|NCT00870454|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of     carisbamate (800 and 1200 mg/day) in patients with diabetic neuropathic pain.   "
230289|NCT00870467|"     To evaluate the potential of adalimumab to inhibit radiographic progression in joint     destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid     arthritis.   "
230290|NCT00870480|"     The purpose of this study to compare the rate and extent of absorption of Actavis Group hf,     Iceland, finasteride and Merck & Co. Inc., U.S.A. (Proscar), finasteride, administered as a 1     x 5 mg tablet, under fasting conditions.   "
231498|NCT00883688|"     The goal of this clinical research study is to learn if the combination of Avastin     (bevacizumab) and Tykerb (lapatinib) can help to control ependymoma in pediatric patients.     The safety of this drug combination will also be studied.   "
230291|NCT00870493|"     Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in     the world. Current treatment with angiotensin converting enzyme (ACE) inhibitor and     angiotensin receptor blocker (ARB) is not entirely effective. Aliskiren, a direct renin     inhibitor, acts on the rate limiting step of the renin-angiotensin axis. In addition to     lowering the blood pressure, recent study in diabetic nephropathy suggests an independent     anti-proteinuric effect. The investigators plan to conduct a randomized placebo-control     cross-over study to evaluate the safety and efficacy of aliskiren in the treatment of IgA     nephropathy. The investigators plan to recruit 57 patients with biopsy-proven IgA nephropathy     and persistent proteinuria despite conventional therapy. They will be randomized to aliskiren     for 16 weeks or no treatment, followed by cross over to the other arm after a washout period.     Proteinuria, albuminuria, renal function, serum and urinary markers will be quantified. This     study will explore the potential anti-proteinuric effect of aliskiren in the treatment of IgA     nephropathy, which has no specific treatment at present.   "
230292|NCT00870506|"     The purpose of this study is to determine the effect of a 5-minute video intervention     regarding organ donation and transplantation on increasing the number of organ donor cards     signed in Northeastern Ohio Bureau of Motor Vehicles (OBMV) branches and on willingness to     donate organs while living. The investigators hypothesize that persons in the intervention     group will sign more donor cards and be more willing to donate organs while living than     persons in the control group.   "
230293|NCT00870519|"     The underlying goal of this study is to assess 123-I MNI-168 SPECT imaging as a tool to     detect ß-amyloid deposition in the brain of Alzheimer's Disease (AD) research participants     and similarly aged and gender matched healthy subjects.   "
230332|NCT00871026|"     In orthodontics, conventional fixed appliances, usually consisting of prefabricated     components, require step-by-step adjustment in order to move teeth in the planned direction.      May treatment be improved with customized archwires?      Study hypotheses:        -  By using CAD/CAM in planning and fabrication of customized archwires, unnecessary tooth          movements can be avoided and teeth can be moved on their direct path to the intended          position.        -  The application of CAD/CAM improves reproducibility, efficiency, and quality of          orthodontic treatment.   "
230294|NCT00870532|"     Targeting the blood supply of cancer, called anti-angiogenesis is a new but proven treatment     strategy. There are two ways of achieving this effect. The first way to specifically target     the molecular pathways that promote new blood vessel formation in cancer. An example of such     an agent is sorafenib, which is an oral agent and which is already in use worldwide for the     treatment of kidney and liver cancers. The second way is to target the cells lining the blood     vessels by using low dose of chemotherapy agents administered at frequent intervals. This     strategy is called metronomic chemotherapy. It is possible that combining agents like     sorafenib and metronomic chemotherapy may further enhance anti-cancer effects. This study     aims to determine the optimal way of combining oral vinorelbine in metronomic doses and     sorafenib. Oral vinorelbine is a chemotherapy agent that is already approved for use in     cancer treatment such as lung cancer. By combining both oral anti-cancer agents to optimize     their anti-angiogenic effects in this study, the potential benefit to the patients can be     tremendous and far-reaching. Special radiologic imagings and blood tests will be incorporated     into this study to help further the understanding of the anti-angiogenic processes of both     agents.   "
230295|NCT00870545|"     This study will expand the Department of Defense (DoD) one time, face-to-face post deployment     BATTLEMIND training for spouses of Operation Enduring Freedom/Operation Iraqi Freedom     (OEF/OIF) Guard/Reserve service members into year-long, telephone groups focusing on     education, skills building and support. The goal is to build spouses' resilience to cope with     reintegration, help them serve as a support system for returning service members, and ease     the transition for families post-deployment.   "
230296|NCT00870558|"     RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It     is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled     ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for     liver cancer.      PURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how     well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in     patients who have undergone treatment for liver cancer.   "
230297|NCT00870571|"     The purpose of this study to assess the single-dose relative bioavailability of Actavis Group     hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fed conditions.   "
230298|NCT00870584|"     This study will evaluate the effect of omalizumab on markers of impairment in patients with     inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in     the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines   "
230299|NCT00870597|"     The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless     vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal     intraocular lens (IOL) implantation.   "
230300|NCT00870610|"     The purpose of this study is to understand what happens to cerebral metabolism during     therapeutic hypothermia for hypoxic brain injury following cardiac arrest.   "
230301|NCT00870623|"     Bloodstream infections (BSI) are a major cause of morbidity and mortality. Community-onset     BSI have an overall attributable mortality of 10-13% while nosocomial BSI mortality ranges     are quite variable from 12-80%. Bloodstream infections are also costly and result in     prolonged hospital stays. Nosocomial BSIs have been shown to increase length of stay by 5-25     days and increase costs $23,000 - 40,000 above matched controls. The duration of therapy     necessary to clear blood stream infections is unknown and no study has systematically     addressed this issue. The use of antimicrobials is also not without consequence. These     include financial cost, side-effects, promotion of superinfection (especially Clostridium     difficile-associated diarrhea), and the promotion of microbial resistance. We hypothesize     that a procalcitonin (host biomarker) and endotoxin (microorganism biomarker)-guided     treatment plan could significantly decrease unnecessary exposure to antibiotics in patients     with bloodstream infections.   "
230302|NCT00870636|"     The purpose of this study is to provide access to intravitreal injection of Avastin in     high-risk infants who do not otherwise qualify for study NCT00702819, an investigational     multi-site study examining Avastin use for retinopathy of prematurity.   "
230327|NCT00870961|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of vitamin D may keep colorectal cancer from forming in patients with colon polyps.      PURPOSE: This randomized phase I trial is studying a vitamin D supplement to see how well it     works compared with a placebo in preventing colorectal cancer in African Americans with colon     polyps.   "
232023|NCT00889382|"     This is a multi-center, randomized, open-label, phase 1/2 study of continuous weekly     paclitaxel and escalating doses of intermittent or continuous OSI-906 in patients with     recurrent/relapsed ovarian and other solid tumors.   "
230303|NCT00870649|"     Objectives:To reduce the risk of S. haematobium pathology recurrences during the three years     following vaccine administration and to control the safety of this therapeutic strategy in     children exposed to urinary schistosomiasis.      Methodology : Phase III trial, self-contained, randomized, double blind, in two parallel     groups receiving 3 injections at D0, W4, W8 and a boost at W52, one group receiving     Bilhvax, the other one placebo, in S. haematobium infected children pretreated by two doses     of PZQ (at W9 and W8) Patient included : Infected school children, 6 to 9 years of age.      Primary objective : To demonstrate a significant delay of recurrence of the schistosomiasis     pathology in vaccine group compared to control group in the 3 years period following the     first administration (between D0 and W152).      Secondary objective : safety      Duration : February 2009 to March 2012   "
230304|NCT00870662|"     The purpose of this study is to determine whether the Automatic Fluid Shunt (AFS) can reduce     the number of paracentesis procedures in patients with refractory ascites.   "
230305|NCT00870675|"     This study compares the accuracy of fast magnetic resonance imaging (MRI) using the half     Fourier single shot rapid acceleration with relaxation enhancement technique to ultrasound in     the diagnosis of fetal abnormalities. The investigators' specific aim is to perform MRI     examinations with ultrafast MRI on fetuses with sonographic morphologic abnormalities. The     investigators' hypotheses are that 1) MRI will demonstrate fetal morphologic abnormalities;     and 2) MRI will add additional information to the sonographic diagnosis which may directly     affect maternal and/or neonatal care.   "
230307|NCT00870701|"     Soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas     members represent 60% of them.      These rare tumors involve complex multidisciplinary care better in centers having expertise.      Loco-regional therapy strategies have evaluated over time for tumors of members leading to     propose more often the combination of a large conservative tumor excision with radiotherapy.     Results have been demonstrated equivalent to those of an amputation in terms of local control     and survival.      The local recurrence rate for sarcomas of the members of any kind after surgery with or     without radiotherapy in the literature varies from 10 to 30%.      The main objective is to achieve a low recurrence rate while maintaining the function. The     question remains the possibility of an absence of irradiation in selected cases in a     de-escalation therapy order.   "
230308|NCT00870714|"     Eligible patients with high-risk prostate cancer who are scheduled to undergo radical     prostatectomy will receive four cycles of therapy with ketoconazole and docetaxel prior to     surgery resection. A cycle of therapy is defined as 21 days (three weeks). Pharmacokinetic     analysis will be performed with the first and second cycle of therapy. All patients will be     evaluated for toxicity, tumor response, and recurrence.   "
230309|NCT00870727|"     The purpose of this study is to develop a better tolerated and more effective pharmacologic     treatment with individuals with Pervasive Developmental Disorder. This is a double-blind,     placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of     Pervasive Developmental Disorder. The investigators hypothesize that aripiprazole will be     more effective than placebo for reducing aggression,tantrum and self-injurious behavior in     children with Pervasive Developmental Disorder.   "
230310|NCT00870740|"     The primary objective of the study was to assess the safety and immunogenicity of extended     treatment with DAC HYP. This evaluation included the following major components:        -  An assessment of safety and immunogenicity of extended treatment with DAC HYP when          administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in          Study 201.        -  An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.        -  An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP          after a 6-month washout period.        -  An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects          who previously received placebo during Study 201.      The secondary objective is to assess the durability of the effect of DAC HYP on multiple     sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans     and clinical MS relapses.   "
230311|NCT00870753|"     Purpose: to examine effects of hatha yoga in treatment of eating disorders.      Methods:      Participants: patients with DSM-IV Anorexia Nervosa, Bulimia Nervosa or Eating Disorders Not     Otherwise Specified will be invited to participate in this study. Exclusion criteria will be     age under 18, serious medical complications, psychosis or increased risk of suicide.      Design: randomized controlled single-blinded trial. Intervention: 2 x 90 min weekly group     sessions for 12 weeks with hatha yoga. Main outcome measure: reduction in Eating Disorders     Examination score. Secondary outcome measures: reduction in body dissatisfaction, depression     and anxiety   "
230312|NCT00870766|"     The purpose of this study is to determine the impact of routinely performed early CT scanning     in terms of diagnostic accuracy, patient management and cost-effectiveness compared to     current imaging practice in patients suffering from acute abdomen.   "
230328|NCT00870974|"     Measurement of metabotropic glutamate receptor type 5 (mGluR5) binding capacity in the brain,     may be a valuable tool in the early detection, understanding, or evaluation of Parkinson     disease (PD), Huntington disease (HD), Fragile X syndrome (FXS), Autism Spectrum     Disorder(ASD), Alzheimer's Disease(AD), and subjects with mild cognitive impairment (MCI).      The goal of this study is to assess [18F]F-PEB positron emission tomography (PET) imaging as     a tool to detect mGluR5 density in the brain of PD, HD, FXS ASD, AD, and MCI research     participants and similarly aged healthy subjects.   "
230329|NCT00870987|"     The purpose of this study is to test the safety and effectiveness of a new malaria vaccine,     the DNA-Ad vaccine. The study is specifically looking at a vaccine regimen against Plasmodium     falciparum, the most deadly form of malaria.   "
230313|NCT00870779|"     Removing a tumor from your brain is hard to do because, very often, brain tumors do not have     boundaries that are easy for your surgeon to find. In many cases, the surgeon can't tell     exactly where the tumor begins or ends. The surgeon usually can remove most of your tumor by     looking at the MRI images that were taken of your brain before surgery. However, the surgeon     does not have any good way to tell if the entire tumor has been removed or not. Removing the     entire tumor is very important because leaving tumor behind may allow it to grow back which     could decrease your chances of survival.      It is possible to detect tumor cells by making them glow with a specific color of light (a     process called fluorescence). This can be done by having you take the drug, ALA, before your     surgery. ALA is a molecule that already exists in the cells of your body. Once enough of it     is in your body, it gets converted into another molecule named PpIX. If blue light is shined     on a tumor that has enough PpIX, it will glow with red light (fluorescence) that can be     detected with a special camera. In this study, we want to determine how the fluorescence (red     light) is related to the tumor which appears in the images that are normally taken of your     brain (which the surgeon uses to guide the removal of your tumor) and the tumor tissue that     will be removed during your surgery. Removing the entire tumor is very important because     leaving tumor behind may allow it to grow back which could decrease your chances of survival.   "
230314|NCT00870792|"     We hypothesized that providing physicians treating with HIV disease, at the time of a routine     outpatient visit, with a detailed report describing patients' adherence with HIV     antiretroviral medications, would improve the quality of the physician-patient interaction,     and also patients' subsequent adherence.   "
230333|NCT00871039|"     The aim of this study is to evaluate the effects of the sedatives propofol and midazolam on     stress response and immune function in critically ill patients with alcohol use disorders who     are undergoing mechanical ventilation.   "
230346|NCT00871208|"     This study is designed to determine whether the addition of topical Altabax (R) to a     treatment regimen of topical corticosteroid therapy speeds clearance of atopic dermatitis and     improves quality of life.   "
230347|NCT00871234|"     The purpose of this study is to determine the safety and effects of etravirine, an HIV     antiretroviral medication, on vascular function.   "
230315|NCT00870805|"     Electroconvulsive Therapy (ECT) remains essential to contemporary psychiatric practice and is     one of the safest and most effective treatments available for depression. Despite modern     advances in pharmacotherapy, about 15-20 per cent of all hospitalised patients receive     treatment with ECT. Its use, however, is limited by concerns over associated cognitive side     effects.      Recent research has suggested that using an ultrabrief pulsewidth with ECT may greatly reduce     cognitive side effects, while maintaining efficacy (Sackeim et al 2008). Preliminary results     were positive for unilateral ECT, however, suggest that for bilateral ECT, dosing may need to     be adjusted to preserve efficacy while reducing side effects. This study will examine the     relative cognitive side effects and efficacy of right unilateral and bilateral ECT given with     a standard pulsewidth or an ultrabrief pulsewidth. Some participants will also receive an MRI     scan before and after ECT.   "
230316|NCT00870818|"     The purpose of this study is to assess the long term safety and efficacy in subjects with     Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).   "
230317|NCT00870831|"     To follow the patterns and natural history of Islet Transplant recipients (the ones that were     involved in the Modified Edmonton Protocol) using oral glucose to check sugar levels as well     as insulin and C-peptide over the course of 5 years   "
230318|NCT00870844|"     The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO)     dosed once daily for 5 days is a safe treatment for patients who have suffered an acute     ischemic stroke.   "
230319|NCT00870857|"     Despite the availability of highly active antiretroviral therapy (HAART), lung diseases     remain a leading cause of morbidity and mortality in those with HIV infection. There have     been no large-scale studies detailing pulmonary complications in the HAART era. Substantial     gaps exist in our knowledge of the spectrum and pathogenesis of pulmonary disorders in this     population, particularly in women and minorities whose numbers with HIV or AIDS have     increased. The Multicenter AIDS Cohort Study (MACS) and the Women's Interagency Health Study     (WIHS) are prospective, multi-center cohorts that follow approximately 5000 HIV+ subjects and     HIV- controls. Although pulmonary disease has not been an area of focus, these established     cohorts provide a unique opportunity to systematically study pulmonary complications of HIV     infection.      Emphysema is of particular interest in the current HIV era because it is likely to increase     as this population lives longer with chronic HIV. HIV-infected persons have an increased     incidence of emphysema compared to those without HIV infection, and it has been hypothesized     that this accelerated disease progression is the result of one or more latent infectious     agents that amplify the pulmonary inflammation. Accelerated emphysema was described in HIV     infection in a predominantly male population before HAART. The current prevalence and     characteristics of HIV-associated emphysema, and the potential impact of gender, have not     been rigorously defined.   "
230320|NCT00870870|"     The purpose of this study is to determine the number of participants whose cancer shrinks or     disappears after treatment on the study.   "
230321|NCT00870883|"     Oxidative stress is associated with kidney damage in several different situations, including     hypotension. In animal models it has been shown that the combination of n-acetylcysteine plus     deferoxamine is superior to its isolate use in the treatment of several diseases. Thus the     investigators aimed to determine if the administration of n-acetylcysteine plus deferoxamine     could prevent renal failure in critical ill patients who develops hypotension.   "
230322|NCT00870896|"     Does tiotropium effect the cough reflex in patients with COPD and chronic bronchitis.   "
230323|NCT00870909|"     The purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is     effective in the treatment of auditory hallucinations in schizophrenia.   "
230324|NCT00870922|"     Muscles and myofascial dysfunction are more often the mechanism and source of pain in oral     fascial disorders (OFD) than the TMJ. Masticatory muscles in patients with TMJ alterations     are more hypertonic, less efficient and more prone to fatigue compared to age and sex matched     controls. It is our opinion that Active Release Technique can be a reliable assessment and     treatment tool in the resolution in cervical-cranio mandibular disorders. Our goal is to     improve masticatory function through treatment of trigger points in the masseter.   "
230325|NCT00870935|"     The purpose of this study is:        -  to determine whether the choice of the device for performing hysterosalpingography on          the basis of the cervix characteristics can reduce the procedure failure rate;        -  to determine whether patient medical history is correlated with the degree of pain          experienced during the HSG procedure.   "
230326|NCT00870948|"     Single dose in healthy volunteers to assess bioavailability (amount of study drug in the     system) between different formulations of ABT-874.   "
230330|NCT00871000|"     This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV     vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children     5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine     according to the 3-5-11 month schedule recommended in Italy.      In this study, MMRV vaccine will also be co-administered to all children.   "
230331|NCT00871013|"     There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma     at the MIRT from 1989 to present. Results have shown that participants treated on these     studies had better outcomes (meaning they have lived longer and had better responses to     treatment) when compared to individuals treated with standard chemotherapy.      Past studies conducted at the MIRT have shown that participants presenting to MIRT who have     already received treatment for myeloma tend to have shorter remissions (disappearance of     signs and symptoms of myeloma) and do not survive as long as participants who come to MIRT     with untreated myeloma. Researchers at MIRT think that one reason for this is may be that the     myeloma cells re-grow in the time when participants are not receiving treatment because they     are recovering from high-dose chemotherapy. In this study, participants will receive several     chemotherapy drugs previously shown to be effective in myeloma, but in lower doses and in     shorter cycles. It is hoped that by giving the drugs in this way, myeloma cells will not have     time to re-grow between cycles, therefore resulting in longer remissions. This study is being     done in an attempt to improve the remission rate and the survival time for participants with     high-risk myeloma.   "
233399|NCT00902369|"     This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical     Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2:     Proof of Concept Study   "
230334|NCT00871052|"     Polymorphic light eruption (PLE) is a photodermatosis with an extremely high prevalence,     particularly among young women (up to 20%). The disease is characterized through itchy skin     lesions on sun-exposed body sites occurring after sun exposure mostly in spring and early     summer. Its etiopathogenesis is unknown but resistance to ultraviolet radiation (UVR)-induced     immunosuppression with subsequent immune reactions against skin photoneoantigens has been     suggested.      The phenomenon of UVR-induced immunosuppression (suppression of CHS) has been well known for     many years. Recent findings showed that regulatory T cells (CD4+CD25+FoxP3+) (Tregs), a     subset of T helper cells, are crucial in UVR-induced immunosuppression. However, the     requirements for the maintenance of peripheral CD4+CD25+ T cells, important in suppression of     immune responses, are still incompletely understood. Recent work suggests that cutaneous     RANKL might be the physiologic missing link that couples UVR to immunosuppression. Epidermal     RANKL, expressed in keratinocytes of inflamed skin due to e.g. UVR exposure was shown to     control the number of Tregs via activation of dendritic cells, hereby mediating UVR-induced     immunosuppression (e.g. suppression of allergic contact hypersensitivity responses). In     addition to the suppression of local cutaneous hyperallergic responses, the development of     systemic autoimmunity is suppressed. A strong inducer of RANKL expression and of Tregs is     vitamin D3 that has been reported to have immunosuppressive effects. Interestingly, patients     with autoimmune disorders (e.g. lupus erythematosus) may exhibit reduced vitamin D3 blood     levels.      This randomized, double blinded left-right body side experimental comparison study was     designed to assess the preventive effect of the vitamin D3 analogue calcipotriol in patients     with PLE. The hypothesis is tested that treatment with a calcipotriol-containing cream can     prevent the UVR-induced development of PLE skin lesions. Better insight into the pathogenesis     of PLE may give clues to develop new therapeutic strategies.   "
230335|NCT00871065|"     Rupture of a cerebral aneurysm is a serious medical condition that may result in permanent     disability or even death just related to the aneurysm rupture itself. Patients who undergo     successful surgical treatment of their aneurysm will rarely experience problems related to     that specific aneurysm in the future. However, blood that is on the surface of the brain from     the initial aneurysm rupture is very irritating to other blood vessels that it comes in     contact with. When these blood vessels become irritated, they spasm and become narrower. This     narrowing restricts blood flow through the vessel, and if severe can result in a stroke that     is caused by inadequate blood flow through the vessel. Depending on location and severity,     this condition of vessel spasm (cerebral vasospasm) may result in permanent disability or     death. Treatment to prevent cerebral vasospasm decreases the risk of stroke. This research is     trying to see if a medication that is FDA approved for the treatment of lung disease and     sexual dysfunction can be used to prevent and/or treat cerebral vasospasm.   "
230336|NCT00871078|"     The purpose of this study is to assess retinal nerve fiber layer thickness and macular     thickness measured with optical coherence tomography (OCT) on patients infected by HIV virus     without ocular manifestations and to correlate these results with perimetric findings     assessed by frequency doubling technology perimetry (FDT).   "
230337|NCT00871091|"     In orthodontics, conventional fixed appliances, usually consisting of prefabricated     components, require step-by-step adjustment in order to move teeth in the planned direction.      May treatment be improved with customized archwires?      Study hypotheses:        -  By using CAD/CAM in planning and fabrication of customized archwires, unnecessary tooth          movements can be avoided and teeth can be moved on their direct path to the intended          position.        -  The application of CAD/CAM improves reproducibility, efficiency, and quality of          orthodontic treatment.   "
230338|NCT00871104|"     The study evaluates the efficacy and safety of fosfomycin and imipenem for the treatment of     methicillin-resistant staphyloccocus aureus infective endocarditis in comparison to     vancomycin, the standard therapy.   "
230339|NCT00871117|"     The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when     co-administered with varicella (Varivax® [varicella virus vaccine live], Merck and Company)     and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine     alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age,     and there is great potential for the vaccines to be given concurrently. The aim of this trial     is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity     or reactogenicity of Kinrix.   "
230401|NCT00862329|"     Dietary protein is the more satiating nutrient, however it is not clear whether satiety may     be influenced by the nature of the protein. This study was designed to assess potential     differences between protein sources on satiety and their relationship with digestive and     metabolic kinetics.   "
230340|NCT00871130|"     The aim is to evaluate the effect of dramatic weight loss after bariatric surgery on thyroid     function (thyroid hormone levels and particulary morphological changes) in the short and     long-term setting of a cross-sectional study. A particular focus will be made with regard to     putting into correlation preoperative thyroid function abnormalities and postoperative     changes over time with respect to the type of bariatric intervention carried out.   "
230341|NCT00871143|"     The aim of the research is to determine if Cognitive Behaviour Therapy (CBT) specific for BDD     is more effective than a credible non-specific form of CBT for treating BDD and its     delusional variant in adults aged 17 or over. This will be done in a single centre randomised     controlled trial that compares specific CBT for BDD versus non-specific CBT over 12 weeks.     The hypotheses to be tested are that: (1) specific CBT for BDD will be more effective than     non-specific CBT at 12 weeks (2) Treatment effects from Specific CBT will be maintained at 1     month follow up. The main study end-point is at 12 weeks and the secondary end-point is at 1     month follow up. A secondary aim is to explore whether delusionality (insight) as measured by     the Brown Assessment of Beliefs and co-morbid depressed mood predicts response to treatment.   "
230342|NCT00871156|"     DDI study of Tafenoquine and Chloroquine   "
230343|NCT00871169|"     This phase II trial studies the side effects and how well irinotecan hydrochloride,     oxaliplatin and cetuximab work in treating patients with unresectable or metastatic     pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth     in different ways. Some block the ability of tumor to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Giving irinotecan     hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.   "
230344|NCT00871182|"     The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to     placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary     disease (COPD).   "
230349|NCT00871260|"     The purpose of this study is to better define the role of a comprehensive stress MRI (which     includes myocardial perfusion imaging, optimized coronary imaging, and myocardial scar     imaging) in medical practice and in patient health management. Information gathered from the     healthy volunteers that participate in this study will be compared to information from the     coronary artery disease patients in this study in order to help further our understanding.   "
230350|NCT00871273|"     The purpose of this study is to evaluate the pharmacokinetics (PK) of capecitabine in     patients who have undergone a total gastrectomy.   "
230351|NCT00871286|"     The purpose of this research study is to determine whether or not computed tomography (CT)     scans performed on patients with symptoms of chronic rhinosinusitis (CRS) but without any     physical signs of the disease will (1) prove to be less expensive in the treatment and     evaluation as compared to current practices, (2) avoid the use of unnecessary antibiotic     prescriptions, and (3) provide a more efficient way to diagnose conditions in patients who     have had CRS ruled out as a cause.      The investigators hypothesize that current guidelines, when applied to subjects with symptoms     of CRS in the absence of physical signs may be associated with (1) increased unnecessary     prescription of antibiotics, (2) delay in further essential workup, and (3) increased overall     health care costs.   "
230352|NCT00871299|"     This study is a randomized, controlled trial of Mindfulness-Based Cognitive Therapy (MBCT)     versus Health-Enhancement Program (HEP) for patients with treatment-resistant major     depressive disorder (MDD). Both arms of the study will continue to receive the standard     medication management treatment as usual (TAU) throughout the study. MBCT is a new technique     that has been found to be effective for prevention of relapse in individuals in complete     recovery from depression. MBCT is a group-based, 8-week intervention that uses mindfulness     meditation as its core therapeutic ingredient. It teaches people to have a different     relationship to depressive thoughts and feelings. This study will use an active condition     called the Health Enhancement Program (HEP) which was specifically developed to serve as a     comparison condition for mindfulness interventions. HEP has been shown to decrease global     stress levels and to increase perceived health. Stress has been considered a contributor to     depression. One hundred and seventy four patients with MDD who have failed two or more     adequate antidepressant trials will be identified and randomly assigned to one of two groups:     MBCT+TAU or HEP+TAU. All patients who enroll in the study will undergo follow-up assessments     at 3, 6, 9 and 12 months following the intervention. A supplemental portion of the study will     enroll 88 patients to undergo functional magnetic resonance imagining (fMRI) scans     immediately before and after treatment to better understand the neural pathways implicated in     depression and those that may be affected through treatment.   "
230353|NCT00871312|"     The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2)     therapy system on the healing of diabetic lower extremity ulcers.   "
230354|NCT00871325|"     The purpose of this study is to compare the dose related effects of orally administered     TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal     motility and colonic transit of solids.   "
230414|NCT00862498|"     This study will test the effectiveness of writing about a traumatic incident to treat     post-traumatic stress disorder in people who have been in car accidents.   "
230355|NCT00871338|"     The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals'     GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy     infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a     booster dose of GSK Biologicals' Menitorix™ at 12 months of age.   "
230356|NCT00871351|"     The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and     ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose     low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target     value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or     changing to rosuvastatin 2.5 mg.   "
230357|NCT00871364|"     The purpose of this study to assess the single-dose relative bioavailability of Actavis Group     hf 50 mg venlafaxine hydrochloride tablets with Wyeth Pharmaceuticals (Effexor®) 50 mg     venlafaxine (as venlafaxine hydrochloride) tablets under fed conditions.   "
230358|NCT00871377|"     The purpose of this study is to determine if Omega-3 fatty acids reduce seizures and modify     cardiac risk factors in people with epilepsy.   "
230359|NCT00871390|"     Atrial fibrillation (AF) is a condition in which the upper chambers of the heart, the atria,     undergo an irregular beating rhythm. Despite the fact that AF is the most common type of     sustained cardiac rhythm disturbance the investigators still do not understand it entirely     and its current therapies are only marginally effective. The overall goal of our project is     to determine the organization and mechanisms of electrical activation patterns during AF in     humans.   "
230360|NCT00871403|"     The main purpose of this study is to determine whether the combination of pazopanib and     pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer     (NSCLC).   "
230361|NCT00871416|"     This trial is conducted in Europe. The primary aim of this clinical trial is to locate and     compare simulated insulin injections (injections of sterile atmospheric air) in normal weight     and obese patients with diabetes mellitus. Injections are done with 6 mm and 12 mm needles     with and without lifting of skin fold at different injection sites.   "
230362|NCT00871429|"     This study is being done because the investigators would like to evaluate product     satisfaction of three test products (product A, product B, product C) that are available at     any drug store. This will be done by measuring any changes in the subjects' answers to the     Skindex-16 questionnaire at two time points (at screening and baseline visit and at follow-up     visit) and by evaluating their responses to the product satisfaction survey that will be     given to them by a study coordinator.   "
230375|NCT00871598|"     Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous     doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the     pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups     will occur at random, and the actual treatment will not be revealed to the investigator or to     the patient during the trial.   "
233400|NCT00902382|"     To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal     teratology and dysmorphology, and infant development up to age 3.   "
230363|NCT00871442|"     Patient Controlled Epidural Analgesia is a widely used and effective means of adult pain     management. However, Parturient Controlled Epidural Analgesia (PCEA) is a relatively new     approach to pain control for the women in labor. With the recent acquisition of new PCEA     technology at Baystate Medical Center it is now possible to make this patient controlled     technology available on the Labor and Delivery unit. This study is designed to determine     whether there is a difference in analgesia, side effects, or analgesic duration in patients     who receive a bupivacaine and fentanyl PCEA for management of labor pain. The present study     hypothesizes that an analgesic protocol that includes a basal infusion rate in addition to a     bolus dose controlled by the patient will have a longer analgesic duration than a pump     protocol that does not have a basal infusion added to a bolus dose controlled by the patient.      Methods:The study population will consist of 100 adult obstetrical patients greater than 36     weeks gestation who request labor analgesia. Patients greater than 5 cm cervical dilation,     patients who have received intravenous opioid agonists, or patients with a contraindication     to fentanyl will be excluded. Patients with pre-eclampsia are also excluded.      One of the following PCEA treatment protocols will be started in a randomized, double blind     fashion.PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml Group 1: Basal Infusion: 0     ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout) Group 2: Basal Infusion:     10 ml/h; Bolus 5 ml q 30min prn (5ml demand dose with 30min lockout) If the patient does not     obtain relief within 30 minutes, the epidural catheter will be dosed with a local anesthetic     and the study will be concluded. The patients without pain relief within 30 minutes are     considered to have failed epidurals and are dropped from the study and the analysis.     Following achievement of satisfactory analgesia, the patient will be evaluated every 30     minutes until they request additional analgesics. The study will end at this point, and the     patient will be treated at the discretion of the anesthesiologist.   "
230364|NCT00871455|"     Insulin-like growth factor I (IGF-I) is used as a measure of the body's ability to produce     growth hormone. Growth hormone is important for muscle tissue as well as many other tissues     in the body. Growth hormone (GH) and IGF-I have been shown to be reduced in many persons with     SCI. Baclofen is a FDA approved drug that is used to treat spasticity. Persons receiving     long-term baclofen therapy have been demonstrated to have increased growth hormone and IGF-I     levels. IGF-I levels will be determined before and after treatment with baclofen. In this     study, the investigators will determine the minimum dose of baclofen at which improvements in     GH and IGF-1 levels occur.   "
230365|NCT00871468|"     The anterior-inferior clavicle plate position will have a lower rate of soft tissue     irritation that limits activity and/or requires hardware removal compared to superior plate     position.   "
230366|NCT00871481|"     This phase I/II trial is studying the side effects of giving laboratory-treated T cells and     ipilimumab together to see how well they work in treating patients with metastatic melanoma.     Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells     when they are put back in the body. Monoclonal antibodies, such as ipilimumab, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving     laboratory-treated T cells together with ipilimumab may kill more tumor cells   "
230367|NCT00871494|"     Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical     bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and     eradication rate in the western clinical trials. Development of azithromycin intravenous     formulation would bring the clinical benefit to patients with pelvic inflammatory disease     (PID) in Japan.   "
230368|NCT00871507|"     This study will assess the safety, tolerability, pharmacokinetics (explores what the body     does to the drug), and pharmacodynamics (explores what a drug does to the body) of     JNJ-38431055 in volunteers with type 2 diabetes mellitus.   "
230369|NCT00871520|"     The accuracy of clinical survival estimates is tested in comparison to objective prognostic     scores.   "
230395|NCT00862251|"     The purpose of this study is to determine the efficacy of switching to a combination tablet     ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose     in those patients who have cardiovascular disease and diabetes mellitus not adequately     controlled on simvastatin 20 mg or atorvastatin 10 mg.   "
230396|NCT00862264|"     Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in     patients with mild to moderate persistent asthma.   "
230370|NCT00871533|"     The presence of malignant cells in lymph nodes is a critical parameter in the staging of     melanoma cancer patients. Assessment of lymph nodes is currently done by histopathology     alone. The long-term survival of melanoma cancer patients who have Stage IB disease (no known     lymph node involvement with a tumor greater than 2 cm) is lower than patients who are Stage     IA (no known lymph node involvement with a tumor less than 2 cm). Likewise, the survival     rates of patients who are judged to be Stage II based on histologically positive level-one     lymph nodes is often no better than that of higher stage patients who have level-two lymph     node involvement. These observations suggest that micrometastases are often present in lymph     nodes that are not detectable by histological assessment.      The collection of Sentinel Lymph Nodes (SLN) and non SLN material outlined in this proposal     will permit both targeted and exploratory studies, without compromising the patient's     diagnosis, on specimens that represent central engines of the immune response and whose     function in the context of tumor progression is largely unknown.      With the advent of an array of new methodologies that utilize minimum material for both     molecular and cellular assessments, acquiring up to 20% and in general the investigators     anticipate the use of 5% on average of SLN and/or non SLN tissue for research purposes, may     prove to be critical to understanding the impact of nodal tumor involvement on patient     outcome and survival.   "
230371|NCT00871546|"     Participants will be randomized to SCH 727965 or a comparator drug (bortezomib for mantle     cell lymphoma [MCL] or alemtuzumab for B cell chronic lymphocytic leukemia [B CLL]). Part 1     of the study will determine the activity of SCH 727965 treatment in participants with MCL and     participants with B-CLL. Part 2 of the study will determine the activity of SCH 727965     treatment in participants who experienced disease progression after standard treatment with     the comparator drug during Part 1.   "
230372|NCT00871559|"     The purpose of this study is to assess the safety and tolerability of REGN421 (SAR153192) in     patients with advanced solid malignancies.   "
230373|NCT00871572|"     This drug is being evaluated for possible treatment of type 2 diabetes mellitus.     Participation in this study is expected to last up to 18 weeks. A goal of this study is to     determine the safety and effectiveness of LY2409021.   "
230374|NCT00871585|"     Prospective, non-comparative, non-interventional, observational study to collect and analyse     real life environment data on advanced prostate cancer patients receiving combination     treatment of medical or surgical castration and bicalutamide according to routine medical     practice in Croatia. The main aim is to evaluate change of PSA level and prescribing     practices based on prostate cancer stage.   "
230379|NCT00871650|"     The overarching aim of this Exploratory/Developmental Research Grant Award (R21) is to     explore the neurobiological correlates of PTSD during REM sleep by using state-of-the science     positron emission tomography (PET) sleep imaging. This study will allow us to gain insight     into the differences in sleep and waking brain mechanisms between veterans with PTSD and     those without PTSD.   "
230380|NCT00871663|"     The study will evaluate the safety, tolerability, maximum administered dose, and dose     limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15     of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple     myeloma or chronic lymphocytic leukemia.   "
230381|NCT00871676|"     This purpose of this study was to test the use of chewing gum as an adjunct to lifestyle     modification to facilitate appetite control and weight loss in overweight and obese     individuals.   "
230382|NCT00871689|"     RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood     stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's     immune system from rejecting the donor's stem cells. When the healthy stem cells and natural     killer cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. Giving     interleukin-2 (IL-2, aldesleukin) after transplant may stimulate the natural killer cells to     kill any remaining cancer cells.      PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy     together with total-body irradiation followed by interleukin-2 (IL-2, aldesleukin), and     umbilical cord blood transplant and to see how well it works in treating patients with     relapsed or refractory acute myeloid leukemia.   "
230397|NCT00862277|"     To evaluate the persistence of bactericidal antibodies in adolescents and adults who received     one dose of Menactra® vaccine approximately four to eight years earlier   "
230398|NCT00862290|"     MicroRNA has been demonstrated to play a crucial role in regulating cell processes. Recently,     microRNA was identified to exist in human serum or plasma, and it might be related to certain     diseases. Several microRNAs are involved in sepsis, such as miR-146, miR-155, and so on. But     whether serum miR-146 is present in serum of septic patients remains unknown. The present     study was designed to identify the existence of specific microRNAs, which might be new     markers for sepsis and its prognosis.   "
230399|NCT00862303|"     The purpose of this study is to show if vaccination with autologous dendritic cells pulsed     with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a     measurable immune response in patients with renal cell carcinoma, and to evaluate the     clinical effect of the regimen.   "
230400|NCT00862316|"     The purpose of this study is to determine whether a computer navigational unit can improve     operating time and consistency during Knee arthroplasty when compared to knee arthroplasty     without a computer navigational unit.   "
230383|NCT00871702|"     Primary Objective:        -  To determine if there is significant toxicity associated with the administration of          CD34-TK75 transduced donor lymphocytes after allogeneic BMT for relapsed hematologic          malignancies      Secondary Objectives:        -  To determine if the patient develops any evidence of anti-leukemic effect from the          administration of CD34-TK75 transduced donor lymphocytes        -  To determine if ganciclovir administration to patients who develop Graft versus Host          Disease (GVHD)results in clinical improvement after infusions of CD34-TK75 transduced          lymphocytes.      Sub-Study Objective      The primary purpose is to perform PET imaging of CD34-TK transduced allogeneic donor T cells     in patients who have relapsed hematologic malignancies after allogeneic hematopoietic stem     cell transplantation (SCT). At this time the limited amount of cGMP quality virus produced by     the NGVL will likely permit the imaging of only 3 patients. Consequently our current     objective will be to establish that the TK-expressing cells can be detected by 18FHBG-PET in     patient organs relevant for performing additional studies that are currently in the planning     stages and for which we are working to produce additional virus.      The ultimate objective will be to use the TK substrate 18FHBG to locate the donor T cells     within the recipient as they exert anti-leukemic effects, and the T cells can then be     eliminated in response to in vivo administration of ganciclovir, before morbidity and     mortality from GvHD occurs. We will use the imaging strategy to define patterns of T cell     trafficking in humans pre and post-DLI infusion, and to determine where the cells reside     while they mediate GVL in contrast to GvHD. We expect to obtain in vivo PET imaging markers     predictive of GvHD before clinical symptoms occur.   "
230384|NCT00871715|"     This study is about arm and hand recovery after a stroke. The investigators are testing an     experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines     challenging, intensive and meaningful practice of tasks of the participant's choice compared     to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual     and customary arm therapy for a duration indicated on the therapy prescription). A second     objective is to characterize current outpatient arm therapy (dosage & content) following     stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke     affecting an arm within the last 106 days.   "
230385|NCT00871728|"     The purpose of this study is to evaluate the participants with toenail onychomycosis (fungal     infection of the nail) confirmed positive by potassium hydroxide (KOH) and bacterial     identification test after administration of itraconazole (ICZ) capsule, to identify the     change in Scoring Clinical Index for Onychomycosis (SCIO) score and to determine the     relationship between the change of SCIO score and mycological cure rate and clinical     improvement.   "
230386|NCT00871741|"     This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A     vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.   "
230387|NCT00871754|"     This is a laboratory study where the investigators hope to look at chromosomal events     implicated in bladder cancer.   "
230388|NCT00871767|"     The aim of this study is to compare the blood levels achieved with a new formulation of     AZD5672 to an existing formulation of AZD5672 used in previous studies   "
230432|NCT00862732|"     The purpose of the study is to test whether cognitive behaviour therapy (CBT) offered by     trained therapists, to people with current active suicidal ideations, is efficacious as a     secondary prevention strategy in Sri Lanka, when compared with treatment as usual provided by     Medical Officers (Mental Health; MO (MH)) of government hospitals   "
230389|NCT00871780|"     The primary objective of the study is to evaluate the evolution of walking capacity as     measured by the timed 100-meter walk test (T100T), timed 25-foot walk test (T25FW), maximum     walking distance (MWD), and Expanded Disability Status Scale (EDSS) during the first year of     therapy with natalizumab. The secondary objectives of this study are as follows:        -  To evaluate the correlation between the MWD and EDSS and both walking tests, the T100T          and the T25FW at Baseline, at Week 24 and at Week 48 of therapy.        -  To determine how well each of the walking tests, T100T or T25FW, predicts walking          limitations in all participants and in the subgroups of participants stratified by          baseline EDSS.   "
230390|NCT00871793|"     Supracondylar humerus fracture are common upper extremity injuries in children accounting for     over 400 fractures per year and approximately 25% of all fractures treated at Seattle     Children's Emergency Department. Most of these fractures are treated with splints and casts     though more than one-third undergo surgical fixation followed by casting. Healing is usually     complete after 3-4 weeks, when casts (and pins, if fixed operatively) are removed and motion     begun. Though stiffness is often a problem after immobilization of adult elbow fractures,     stiffness after pediatric elbow fractures is regarded as typically transient. This study     addresses the question Does early motion of the arm with physiotherapy promote the return of     function and motion in patients with supracondylar humerus fractures? The investigators will     conduct a prospective randomized trial to determine the effect of six occupational therapy     visits over a five week period of time on elbow function and mobility after supracondylar     humerus fracture. The investigators will measure motion of the elbow and administer the child     and parental Activity Scale for Kids performance versions (ASKp) assessment tool to answer     this question.   "
230391|NCT00871806|"     The study will evaluate whether the blood concentrations of eletriptan administered using two     test formulations of oral disintegrating tablets are comparable to those observed with the     standard commercial tablet.   "
230392|NCT00871819|"     The objective of this study is to evaluate extent, location, and perception of paresthesia as     a function of anode/cathode configuration.   "
230393|NCT00871832|"     It is currently standard of care in many Medical and Surgical ICU's to institute a nurse     driven insulin protocol in maintaining tight glucose control in the critical patient. Many     articles have been written to address this topic. However, there is no current data regarding     the use of glycohemoglobin as a marker of risk of morbidity and mortality. In our study we     would like to determine whether or not the HbA1C could be used as a marker of morbidity and     mortality. The HbA1C is a simple blood test that may be added on to any CBC collection tube;     a blood sample that critical patients have drawn up to several times a day. The investigators     would analyze this information in respect to the rest of the clinical data collected     regarding the patient's illness.   "
230394|NCT00862238|"     In the study, homeless youth from a drop-in site and faculty from UCLA and California     Institute of the Arts will develop, pilot test and evaluate a youth-based drug and     health-promoting program. It is hoped that this program will help in the development of a     program that can be further tested in a larger study and lead to the development of an     innovative and effective drug counseling program that youth situated in homeless sites will     utilize.   "
230402|NCT00862342|"     Bevacizumab beyond progression has been proven to be safe in the community setting (BRiTE)     and in the post-marketing study (BEAT), and confirmed its efficacy and safety in the first     line with all regimens of chemotherapy. A total of 1,953 patients were treated in BRiTE. At     median follow-up of 17.5 mo, there were 1,369 1st PD and 839 deaths. Among patients with 1st     PD, 65.2% received any 2nd-line chemotherapy, 34.8% received cetuximab, and 53.8% received     BBP. In a multivariate analysis, Bevacizumab beyond first progression and exposure to any     2nd-line chemotherapy were independently associated with increased overall survival (both p <     0.0001). Bevacizumab beyond progression appears to be associated with longer overall in     BRiTE.      The investigators planned a prospective study to prove this phenomenon of bevacizumab beyond     progression.   "
230403|NCT00862355|"     Bioequivalence study of SPARC147609   "
230404|NCT00862368|"     Parents of Asthmatics Quit Smoking (PAQS-2) is a randomized controlled trial of a smoking     cessation intervention for parents who smoke. Children had either a diagnosis of asthma (and     an asthma emergency within the past 3 months) or were healthy (and had no medical conditions     in the past 3 months). The study intervention aimed to help parents (or caregivers) quit     smoking and reduce children's second hand smoke exposure. Participants received 2 home     counseling sessions with asthma education (if they had a child with asthma), child wellness     (if they had a healthy child) and smoking cessation counseling (including objective feedback     on how much smoke the child was exposed to). Parents of children with asthma were then     randomized into 2 groups; one group received 6 counseling phone calls focused on motivating     smoking cessation and a second round of feedback on smoke exposure (Enhanced). The other     groups received six calls focused on asthma (PAM asthma group) or child wellness (Healthy     group). We had 2 primary aims. First, to explore the teachable moment we compared quit     rates between the parents of children with asthma to the parents of healthy children. We     hypothesized that the Asthma group would have significantly greater quit rates than the     Healthy group and lower levels of environmental tobacco smoke in the home. We also     hypothesized that parents who smoke and have children with asthma would have greater changes     in the variables associated with teachable moment compared to parents who smoke and have a     healthy child. --- The second primary aim focused on the parents of children with asthma. We     assessed the effectiveness of adding telephone smoking cessation counseling to the 2 home     counseling visits. For this, we compared the 2 groups of randomized subjects: those who     received 6 counseling calls and feedback on smoke exposure (PAM-Enhanced) and those who     received 6 counseling calls focused on asthma education (PAM-Asthma). We hypothesized that     the PAM-Enhanced group would have significantly greater quit rates than the PAM-Asthma group,     lower likelihood of smoking relapse, and lower levels of environmental tobacco smoke in the     home. We also explored the hypothesized role of precaution effectiveness (i.e. quitting     smoking will be associated with benefits for self and child) and self-efficacy for quitting     as mediators of the effectiveness of PAM-Enhanced/Asthma. A third aim was to compare asthma     symptoms over time between the two groups.   "
230405|NCT00862381|"     the objective of the study is to assess the value of substitution with 200mg/24h of     hydrocortisone for 48 hours for patients in intensive care who have received a single     injection of etomidate   "
230406|NCT00862394|"     To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate     100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the     corresponding dose of CHF 1535 via HFA-134a extrafine pMDI in terms of pulmonary function     in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with     inhaled corticosteroids   "
230407|NCT00862407|"     This research study is about the effect heart-lung bypass procedures have on the vital organs     (brain, heart, lungs, and kidneys) during open-heart surgery in pediatric patients. There are     two types of heart pumps used in surgery requiring heart-lung bypass; one pumps the blood     continuously through the body and the other pumps the blood with repeated pulses. Both pumps     are approved for clinical use by the FDA. Although 90% of institutions still use     non-pulsatile flow, some studies show there may be benefits to using pulsatile flow during     surgery.      The investigators want to learn whether the vital organs (brain, heart, lungs, and kidneys)     respond differently to one method than they do to the other. Approximately 300 children will     take part in this research at the Hershey Medical Center.   "
230408|NCT00862420|"     Primary objective:        -  To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower          risk of the safety events of interests in patients with peripheral arterial disease          (PAD)      Secondary objectives:        -  To compare the risk of bleeding adverse events, serious adverse events and overall          safety of clopidogrel with ticlopidine        -  To compare the risk of vascular events of clopidogrel with ticlopidine        -  To document the long-term safety of clopidogrel for a total of 52 weeks        -  To document the vascular events of clopidogrel for a total of 52 weeks   "
230409|NCT00862433|"     Background:        -  Vitamin E is an antioxidant that reduces the damaging effects of oxygen in the body.          Most American men (90%) and women (96%) do not get enough vitamin E from their diets;          however, the amount of vitamin E needed by the body has been studied only in men, not          women. In addition, it is unknown whether another antioxidant, vitamin C, helps vitamin          E in protecting the body. Because vitamin E is a fat-soluble vitamin, how much body fat          a person has could affect the amount of vitamin E needed for protection.      Objectives: This study has three arms to examine vitamin E requirements:        -  To determine the amount of fat required to get the best vitamin E absorption from a          meal.        -  To determine the amount (i.e., best dose) of vitamin E that must be consumed before it          can be measured in the blood.        -  To examine how vitamin E and vitamin C work together in the body, in conjunction with          diet and vitamin supplements.      Eligibility:        -  Arms 1 and 2: Women between the ages of 18 and 40 years who have a normal weight and          body mass index (BMI) of 27 or less.        -  Arm 3: Women between the ages of 18 and 40 years who have a normal weight (BMI 27), who          are overweight (BMI > 27), or who are overweight (BMI > 27) and have non          insulin-dependent diabetes.      Design:        -  Arm 1: Five studies, each lasting 1 month with 1 month off between studies (total study          = 10 months). Participants will take 500 1,000 mg of vitamin C twice daily for 2 weeks          before admission to the clinical center for 1 week.        -  Study 1: Participants will eat breakfast containing a known amount of fat, after which          they will take a vitamin E pill as well as receive an IV injection of vitamin E. Other          foods contain only negligible amounts of vitamin E. Blood and urine samples will measure          levels of vitamin E and other substances.        -  Studies 2 5: Outpatient visits will consist of the same tests as in Study 1; however,          the amount of fat in the breakfast will range from 0% to 40% in random order. During one          of the studies, an adipose tissue biopsy will be collected to determine how much vitamin          E is in the tissues.        -  Arm 2: Five studies, each lasting 1 month with 1 month off between studies (total study          = 10 months). Preparation for Arm 2 is the same as in Arm 1. The proportion of fat,          muscle, and water in the body will also be measured.        -  Study 1: Participants will eat breakfast containing 30% fat, after which they will take          a vitamin E pill as well as receive an IV injection of vitamin E. Conditions and          procedures are the same as in Arm 1.        -  Studies 2 5: Outpatient visits will consist of the same tests as in Study 1; however,          the amount of vitamin E in the breakfast will range from 2 to 30 mg in random order.        -  Arm 3: Outpatient (2 to 6 weeks) and inpatient studies (4 to 6 weeks).        -  Outpatient study: Participants will take 500 1,000 mg of vitamin C daily and provide          blood and urine samples, as well as an adipose tissue sample.        -  Inpatient studies: Two vitamin E inpatient studies. Before these begin, participants          vitamin C blood levels will be reduced by means of a diet low in vitamin C. Blood tests          will determine how quickly vitamin C leaves the body. Once the vitamin C level is          reduced, the first vitamin E study will begin.      Study A: The procedure for this study is the same as in Arm 2, Study 1.      Study B: The procedure for this study is the same as in Study A, except that the participants     blood vitamin C levels will be higher.   "
230410|NCT00862446|"     Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a     long period of time frequently develop liver damage. The fat used is called intralipid and is     made from soybean oil. There is a suggestion in the literature that using fishoil based fats     called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer     babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver     damage reverses.   "
230411|NCT00862459|"     The purpose of this study is to look at the safety (what are the side effects) and efficacy     (how well does it work) of Gadavist when used for taking images of the brain and spine. The     results of the MRI with Gadavist Injection will be compared to the results of MR images taken     without contrast and with the results of the MR images taken with OptiMARK.   "
230412|NCT00862472|"     The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS,     dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the     morning.   "
230413|NCT00862485|"     The purpose of this study is to study MCA Doppler before and after exchange transfusion in     newborns.   "
230415|NCT00862511|"     All metal implants release metal ions because of corrosion. Total knee arthroplasty implants     have large metal surface areas and therefore substantial potential for corrosion. It is     planned to compare changes in serum levels of metal ions in patients after implantation of     cemented unconstrained total knee arthroplasty covered with or without a passivating surface.     Serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared     between the two groups, as well as with those of 130 control patients without implants.   "
230416|NCT00862524|"     This is a 2-phase study during which patients with advanced/metastatic solid tumors will     receive investigational study drug ARRY-334543 and gemcitabine.      The study has 2 parts. In the first part of the study, Phase 1, patients with     advanced/metastatic solid tumors will receive increasing doses of study drug in combination     with gemcitabine in order to achieve the highest dose of study drug possible that will not     cause unacceptable side effects. Patients will be followed to see what side effects the     combination causes and what effectiveness the combination has, if any, in treating the     cancer. Approximately 24 patients from the US will be enrolled in Part 1 (Completed).      In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will     receive the best dose of study drug, in combination with gemcitabine, determined from the     first part of the study and will be followed to see what side effects the combination causes     and what effectiveness the combination has, if any, in treating the cancer. Approximately 42     patients from the US will be enrolled in Part 2 (Withdrawn).   "
230417|NCT00862537|"     An extension study for subjects with prior participation in previous resonator studies using     low level magnetic fields to treat some of the symptoms of idiopathic Parkinson's Disease.   "
230418|NCT00862550|"     PRIMARY AIM        1. Determine the feasibility of providing true and sham acupuncture treatment to patients          at Fudan University Cancer Hospital (Cancer Hospital) who are receiving radiation          treatment for cancer of the head and/or neck area.           SECONDARY AIMS        2. Determine if true acupuncture is more effective than sham acupuncture for preventing          radiation-induced xerostomia among cancer patients at Cancer Hospital.        3. Determine if true acupuncture is more effective than sham acupuncture for reducing the          severity of radiation-induced xerostomia.   "
230429|NCT00862693|"     Immunoglobulin A (IgA) nephropathy is the common primary glomerulonephritis in the world.     Much literature suggests that vitamin D and its analogs have profound effects on immune     system function and glomerular mesangial cell proliferation. Therefore, the investigators     plan to conduct a randomized clinical study to evaluate the efficacy of Calcitriol in the     treatment of IgA nephropathy. Forty patients with biopsy-proven IgA nephropathy will be     recruited. They will be randomized to Calcitriol for six months or no treatment. Proteinuria,     renal function, serum and urinary inflammatory markers will be monitored. This study will     explore the potential anti-proteinuric and anti-inflammatory effects of Calcitriol in the     treatment of IgA nephropathy, which has no specific treatment at present.   "
230430|NCT00862706|"     The purpose of this study is to investigate the efficacy of telbivudine in Blacks/African     Americans and Hispanics/Latinos with compensated chronic hepatitis B during 52 weeks of     treatment   "
230419|NCT00862563|"     This is a double-blind, placebo-controlled, parallel group design study with 4 treatment     groups; levetiracetam, zonisamide, topiramate, and placebo control. Subjects will receive     study medications for 14 weeks. Potential subjects will be initially screened for interest in     study participation and alcohol consumption level to determine basic eligibility by     telephone, or in person. Individuals who meet telephone screening criteria will be scheduled     for a clinic appointment to obtain informed consent and conduct screening assessments.     Subjects who report average drinks per day that are within the guidelines for safe levels of     alcohol consumption (i.e. 2 drinks/ day males; 1 drink/day females-HHS standard) in the two     weeks prior to screening will be excluded. Subjects meeting screening criteria will be     scheduled for a second randomization visit. During this visit baseline assessments will be     obtained. Eligible subjects will then be randomized to a treatment group and will be provided     with the first week's study medications. The goal is to directly compare the efficacy and     tolerability of two novel anticonvulsants, zonisamide and levetiracetam, with placebo, and     using topiramate, which has extensive evidence supporting its efficacy in alcoholism, as a     positive control group. We believe that this will be the first direct comparison of these     agents in alcoholism, and the results will provide information on the efficacy and safety of     the medications.   "
230420|NCT00862576|"     This is a case control study of the association between burning mouth syndrome and sleep     dysfunction. Cases will comprise of patients diagnosed with burning mouth syndrome at the     UCSF oral medicine clinic. Controls will include patients with leukoplakia, pigmented     lesions, traumatic lesions, benign tumors, mucoceles, and pemphigoid matched on age (5 years)     and gender to the cases. New patients as well as those presenting for follow-up visits will     be eligible.      Each case and control subject will be administered the following 4 questionnaires by     interview: (1) enrollment questionnaire (2) Sleep scale from the medical outcomes study     (MOS), (3) current sleep status scale and (4) a numerical rating scale for measurement of     oral symptoms.      Cases (BMS patients) will be followed in the clinic or by telephone contact once per month     for the following 6 months and questionnaires 1 (question 6 only), 2, 3 and 4 will be     administered by interview.   "
230421|NCT00862589|"     The incretin hormone glucagon-like peptide-1 (GLP-1) has known insulinotrophic and     glucagonostatic properties. However, inpatients with type 2 diabetes mellitus (T2DM)it is     shown, that the beta cell sensitivity towards GLP-1 is decreased, when comparing to healthy     controls. Further, these patients have decreased GLP-1 response to a meal.      The aim of this study is to elucidate if the diabetic hyperglucagonemia, seen in these     patients both during fasting and in a postprandial condition, is coursed by a decreased     sensitivity to GLP-1 in the diabetic alpha cell.      Ten T2DM patients and ten matched healthy control subjects will be examined on two separate     days. Day 1: increasing GLP-1 infusions and Day 2: saline. During both days plasma glucose     (PG) will be clamped at fasting level (FPG).      Patients with T2DM will be submitted til a Day 3, here PG will be normalized over-night by an     adjustable insulin infusion, on the following day the GLP-1 infusion of Day 1 will be     repeated.      The hypothesis is that these patients have decreased alpha cell sensitivity to GLP-1 as is     the case with the beta cell sensitivity. This decreased sensitivity, the investigators     speculate, contributes the defect suppression og glucagon and thereby to the increased PG     levels seen in T2DM. Further the investigators will elucidate if this sensitivity can be     increased by normalizing the diabetic PG to a normal FPG level.   "
230448|NCT00862953|"     This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the     evaluation and treatment of subjects with obesity. The program puts emphasis on intervention     with appropriate diet and physical exercise, and supports the patients in achieving long-term     behaviour changes. Interventions which are compared are normal vs high protein/low carb     diets.   "
230449|NCT00862966|"     The purpose of this study is to determine whether the application of 47% citrate lock     solution decreases the incidence of infection and thrombosis of central venous catheter in     hemodialysis population.   "
232223|NCT00892255|"     The purpose of this protocol is to pathologically evaluate the destruction by microwave     ablation of primary and metastatic liver tumors. The primary aim is to measure tissue     destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System.   "
230422|NCT00862602|"     Ten to 50% of women with gestational diabetes (GDM), or glucose intolerance first recognized     during pregnancy, develop diabetes within 5 years after delivery. Although intensive     interventions can reduce diabetes incidence in women with impaired glucose tolerance, it is     unknown if such strategies would be effective in women with GDM. Women with recent GDM, even     though no longer pregnant, face significant barriers to lifestyle modification, including     caregiving responsibilities and low perception of risk. Web-based programs can reinforce     physical activity through visual feedback of pedometer output, tailored messaging, education,     and on-line communities. Such a program is currently available for adults with chronic     disease and is led by Dr. Richardson, a co-PI on this application. Using data from focus     group and survey work conducted by Dr. Kim, the other co-PI, this program can be modified to     women with recent GDM. For Specific Aim 1, we propose to adapt a chronic disease web-based     pedometer program to women with recent GDM. For Specific Aim 2, we propose to conduct a pilot     and feasibility study of the program. The intervention will last 12 weeks.   "
230423|NCT00862615|"     This project aims to assess the impact of chronic micro-inflammation on age-related loss of     muscle (sarcopenia) and bone (osteopenia). The hypothesis is that chronic micro-inflammation     and oxidative stress, which prevalence increases during ageing, may participate in the     pathogenesis of both sarcopenia and osteopenia.   "
230424|NCT00862628|"     The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced     small-intestinal injuries.   "
230425|NCT00862641|"     This study is intended to determine the safety and tolerance of regadenoson in subjects with     asthma or chronic obstructive pulmonary disease.   "
230426|NCT00862654|"     The objective is to assess different treatment regimens with Clobetasol propionate shampoo     0.05% in the treatment of scalp Seborrheic Dermatitis.   "
230427|NCT00862667|"     The purpose of this study is to investigate the time course of PF-00241939 concentration in     the blood following dosing by oral inhalation from dry powder inhalers.   "
230428|NCT00862680|"     The goal of this clinical research study is to learn if adjusting the PET/CT scanner to allow     for breathing motion can improve the quality of PET/CT images.   "
230433|NCT00862745|"     Six hundred and thirty-six women diagnosed with urge urinary incontinence (UUI) by a     three-item self-administered questionnaire (3IQ) will be randomized to 12 weeks of     fesoterodine or matching placebo. The study will take place at up to 14 clinical sites in the     US. All participants who complete the 12-week randomized trial will be offered open-label     fesoterodine for an additional 9 months.      The hypothesis of the randomized controlled trial is that among women diagnosed with urge     incontinence using the 3IQ, fesoterodine is more effective than placebo in reducing the mean     number of urge incontinence episodes per day.   "
230434|NCT00862758|"     Application for Compassionate Use of Tocilizumab in a Boy with Severe Polyarticular Juvenile     Idiopathic Arthritis (JIA) Unresponsive to All Licensed Medications.   "
230435|NCT00862784|"     The purpose of this study is to test how long participants with colorectal cancer live     without progressive disease when being treated with IMC-1121B (ramucirumab) and the modified     FOLFOX-6 chemotherapy.   "
230436|NCT00862797|"     Leakage of fluid from the subglottic space to the lungs occurs along the longitudinal folds     within the wall of endotracheal tube (ETT) cuffs. In this project the researchers investigate     the possible effect of swallowing on the pressure course in the ETT cuff.   "
230437|NCT00862810|"     To determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types     6, 11, 16, and 18) vaccine in 9-18 year old girls elicits an equivalent immune response     (geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd     dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing     schedule. This is a prospective observational study of healthy 9-18 year old female patients     receiving either a second or third dose of HPV vaccine as part of their well child care.     Immune responses to HPV types 6, 11, 16 and 18 will be measured both before and 1 month after     the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV     vaccine when administered at naturally occurring longer dosing intervals to the immune     response to HPV vaccine when administered as routinely recommended.      Girls receiving a 3rd dose of HPV vaccine in addition to concomitantly administered vaccines     by injection were randomized to receive either the HPV vaccine first or their concomitantly     administered vaccines first. Pain following vaccination was assessed in each arm using the     Faces Pain Scale - Revised.      Please note: This record refers only to the randomized portion of the study where pain     following vaccination was assessed. Please refer to NCT02280642 for the observational portion     of the study.   "
230799|NCT00867607|"     A Double-blind, Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of     Three Weeks of Daily Dermal Application of MRX-6 or steroid on the Treatment of Mild to     Moderate Allergic Contact Dermatitis of the Hand and Forearm.      Total number of patients: up to 80.   "
230438|NCT00862823|"     The primary objective of this study is to determine the average bioequivalence of tenofovir,     emtricitabine and efavirenz in an extemporaneously prepared oral liquid formulation (test     formulation) compared with the commercially available tablet formulation (reference     formulation). The study is designed as an open-label, randomized, 2-period, 2-treatment,     2-sequence, single-dose intensive pharmacokinetic study conducted in healthy volunteers.     Subjects will be randomized to receive the Atripla tablet (reference formulation) or the     Atripla tablet crushed and mixed in OraSweet solution (test formulation) on Study Day 1.     Subjects will undergo a 12-hour intensive pharmacokinetic evaluation after ingesting a single     dose of either the test or reference formulation. On days 2 and 3, subjects will provide an     additional pharmacokinetic sample 24 and 48 hours post dose, respectively. Subjects will     complete a washout period from day 2 to day 14 during which no study drugs will be ingested.     On day 14, subjects will ingest either the reference or test formulation (opposite of the     formulation received on Study Day 1). All subjects will undergo another 12-hour intensive     pharmacokinetic evaluation. On days 16 and 17 subjects will provide an additional     pharmacokinetic sample 24 and 48 hours post dose, respectively. Adverse events and     concomitant medications will be documented throughout the study.      The sample size is 16 and is based upon a 10% drop-out rate (i.e. due to lost to follow-up,     treatment discontinuation, etc.). Since the investigators are expecting two subjects not to     complete the study, the investigators expect 14 evaluable subjects. If the discontinuation     rate is greater than 10%, the investigators will continue to enroll until the investigators     get 14 evaluable subjects. The primary endpoint is to determine average bioequivalence for     test and reference formulations of tenofovir, emtricitabine and efavirenz according to the     FDA guidance on bioequivalence testing. The ratio of the test to reference formulation mean     Cmax and AUC24 for each drug and the 90% confidence interval around each mean ratio will be     determined. Average bioequivalence will be met if 90% confidence intervals around the Cmax,     and AUC24 mean ratios for each drug falls within the FDA's predefined limits of 0.80 to 1.25.   "
230439|NCT00862836|"     This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in     70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial     cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national     centers will participate in phase I of the study. If the starting criteria for phase II of     the study are met at the end of phase I, a total of approximately 20 national centers will     participate in phase II of the study.   "
230440|NCT00862849|"     Insulin lispro and regular human insulin are Food and Drug Administration (FDA)-approved     medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20)     is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs.     In this study, rHuPH20 will be co-administered with both insulin lispro and regular human     insulin in order to determine if it improves the absorption of these insulins to more closely     mimic the body's natural increase in insulin in response to a meal.   "
230441|NCT00862862|"     Objective: The objective of the study is to evaluate the ability of current vancomycin dosing     strategies to attain the pharmacodynamic target of an area under the curve (AUC) to minimum     inhibitory concentration (MIC) ratio greater than 400:1 for patients with a suspected or     documented Staphylococcus aureus infection.      Primary Outcome: The primary outcome is the percentage of vancomycin dosing regimens that     achieve AUC:MIC ratio > 400 on the first occurrence of vancomycin use in patients with a     suspected or documented S. aureus infection at The Nebraska Medical Center.      Secondary Outcomes:        1. To assess the probability that vancomycin AUC:MIC ratios obtained from The Nebraska          Medical Center patients exceed a therapeutic threshold using S. aureus MICs from          isolates obtained from The Nebraska Medical Center.        2. Using MIC data from the TRUST Study database (large national surveillance database) and          the vancomycin AUC data obtained from TNMC patients, perform a Monte Carlo analysis that          will assess the probability of achieving a therapeutic vancomycin threshold with a large          number of isolates.   "
230442|NCT00862875|"     The objectives is to compare the changes in body composition (primary objective), diabetes     parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin®     4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and     insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type     2 diabetic patients failing on oral diabetic agents .   "
230443|NCT00862888|"     The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on     erectile activity in males suffering from erectile dysfunction as well as examining the     safety and toleration of the drug.   "
230444|NCT00862901|"     This research is intended to explore a new approach to therapy when breast cancer recurs in     the skin. The treatment, known as continuous low-irradiance photodynamic therapy, or CLIPT,     has shown great promise in animal studies. The investigators goal is to evaluate CLIPT in     people, using a novel light delivery system, to assess its side effects and the benefit it     has in treating cancer. The investigators goal is to develop a safe, effective therapy that     can be given in the doctor's office or possibly at home.   "
230445|NCT00862914|"     MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length,     capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs     (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of     complementarity. miRNAs have recently been shown to play pivotal roles in diverse     developmental and cellular processes and linked to a variety of skin diseases and cancers. In     the present study the researchers investigate the immunohistochemical distribution of Dicer     in benign and dysplastic melanocytic naevi as well as in cutaneous malignant melanoma     compared to intraindividual healthy control.   "
230446|NCT00862927|"     The objectives of this proposal are to examine the role of context in a virtual reality (VR)     environment and to explore the extent to which cues (i.e., contextual cues or explicit     smoking cues) influence craving and physiological arousal within VR.      The current study seeks to determine whether smokers, placed in the context of a VR     convenience store devoid of explicit smoking cues, will experience less craving and     physiological arousal, compared to exposure to the same VR environment containing explicit     smoking cues. This important line of inquiry will help clarify the influence of environmental     contexts that may contribute to the overall reactivity effects (e.g., craving, arousal)     smokers experience when confronted with cues associated with smoking.   "
230447|NCT00862940|"     Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity     associated with excessive glutamate release and calcium overload in neurons. Previous studies     have shown that memantine helps to treat the symptoms of Alzheimer's Disease (AD). In AD, the     rate of brain tissue loss, or atrophy, is faster than in normal aging and this seems to go     hand in hand with some of the symptoms of the disease. This suggests that memantine treatment     in AD could provide both symptomatic improvement and neuro-protective effects. The purpose of     this study was to show whether memantine, in addition to providing symptomatic benefits, can     slow the rate of brain atrophy as assessed using magnetic resonance imaging (MRI) technology.   "
230815|NCT00867815|"     The primary objective of this study is to determine whether the use of PDE5 inhibitors     (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.   "
230450|NCT00862979|"     This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and     mycophenolic acid is associated with a better renal outcome as compared to the standard     regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while     both treatments are expected to be comparable with respect to efficacy.   "
230451|NCT00862992|"     The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed     doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets     will be administered to patients starting at an initial dose, followed by up-titration to a     fixed dose (low, medium or high) for 14 days.   "
230452|NCT00863005|"     The purpose of the study is the assessment of the barrier impairment, clinical skin condition     and bacterial colonization status in patients with atopic eczema following topical treatment     with K201 cream and a comparator twice daily over a 4-week treatment period.   "
230453|NCT00863018|"     The purpose of this trial is to study the change in corneal endothelial cell after glaucoma     surgery, non-contact specular microscopic examination is performed for the patients who     underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery     prospectively. Change in corneal endothelial cell density, hexagonality, and coefficient of     variation of cell area will be analyzed and compared to the baseline and between the types of     the surgeries.   "
230454|NCT00863031|"     The aim of this study was to determine whether screening followed by brief PSC provided by     primary care doctors could improve the quality of life of elderly patients with unrecognized     psychological problems in primary care. The following hypotheses were tested:        1. Elderly patients screened positive of psychological problems had poorer health-related          quality of life (HRQOL) than those who were screened negative.        2. Primary care doctors could be trained to provide brief PST.        3. Brief PST by a trained primary care doctor could improve the HRQOL of the elderly who          were screened positive for psychological problems.   "
230455|NCT00863044|"     This study is to test the safety of high frequency-low volume ventilation during off pump     coronary artery bypass as reflected in the near infrared spectroscopy values for cerebral     oxygenation.   "
230456|NCT00863057|"     Neuropathy results from damage to the nerves in the feet and legs. It is usually experienced     as pain, tingling or numbness. In HIV-infected people, neuropathy can result from the     infection itself or be a side effect of antiretroviral treatment. The purpose of this study     is to determine whether two different drugs, methadone and duloxetine, reduce     neuropathy-associated pain in HIV-infected people. This study will also examine whether     utilization of both of these drugs is more effective than treatment with only one.   "
230457|NCT00863070|"     The purpose of this study is to determine whether patients who have undergone exstrophy     closure may be at risk for long-term orthopedic issues manifest by gait abnormalities. This     study is a descriptive analysis of the study cohort's gait patterns and pelvic structure.      Specific Aim 1: to determine whether patients with classic bladder exstrophy who underwent     closure demonstrate gait abnormalities.      Hypothesis 1: Patients undergoing closure of bladder exstrophy (with or without pelvic     osteotomy) demonstrate gait abnormalities compared with a reference population.      Hypothesis 2: Patients undergoing closure of bladder exstrophy (with or without pelvic     osteotomy) will have below normal functional survey scores.   "
230470|NCT00863239|"     The purpose of the study was to assess in subjects with chronic hepatitis C (treatment-naïve,     genotype 1) receiving weight-based doses of ribavirin the virologic response to 3 dose levels     of Locteron™, dosed every 2 weeks, in comparison with PEG-Intron™ dosed weekly.   "
233556|NCT00914446|"     The main aim of this work will be to identify a profile of gene expression by microarray in     the liver which might allow to differentiate obese subjects having a normal liver from those     with steatohepatitis or steatosis.   "
230458|NCT00863083|"     The purpose of the study is to examine the extent to which two different reward systems     implemented in the context of a multi-family pediatric weight management group differentially     promote adoption of healthy eating and activity habits among overweight and obese 8-17 year     old youth. Participants will be randomly assigned to one of two reward conditions: rewards     for attendance only or rewards for attendance and goal attainment. We hypothesize that all     participants will demonstrate significant increases in healthy nutritional choices and     physical activity and significant reductions in sedentary activity from pre-intervention to     post intervention. We expect that participants in attendance plus goal attainment reward     condition will demonstrate significantly greater improvements than participants in the     attendance only condition.   "
230459|NCT00863096|"     Public Health Research Institute (PHRI) is carrying out a 15 month research and advocacy     project with the goals of generating critical data on acceptability, identifying determinants     and facilitators of HPV vaccine uptake in adolescent girls; and investigating physicians'     attitudes to identify predictors of intention to recommend immunization in Mysore, India.   "
230460|NCT00863109|"     The primary objective of this study is to evaluate the impact of chronic hepatitis C (CHC),     and the treatment thereof with peginterferon alpha-2b (PEG) and ribavirin (RBV) according to     standard clinical practice, on the health-related quality of life (HRQL) of a cohort of     participants throughout 72 weeks of follow-up. HRQL was assessed using the 36-Item Short-Form     Health Survey (SF-36) and the Chronic Liver Disease Questionnaire-Hepatitis C Virus     (CLDQ-HCV).   "
230461|NCT00863122|"     Tumors can grow on the auditory nerves and can cause hearing loss. A common type of tumor     that does this is a vestibular schwannoma (VS), or acoustic neuroma. These tumors are not     cancerous. Most often, people have only one VS. Occasionally, people have more than one VS     and may have a condition called neurofibromatosis type 2 (NF2).      Because VS can cause hearing loss, many people with VS will have treatment to preserve their     hearing. This treatment usually involves surgery or radiation therapy. There are risks to     these procedures, and sometimes they do not work to prevent hearing loss. Because surgery and     radiation have risks and are not able to help everyone with VS, other methods of treatment     are being explored. One area of exploration is looking to see if there is a drug that can be     taken that might prevent the VS from growing larger and causing hearing loss, and might     possibly even cause the VS to shrink in size.      This study is exploring whether a drug that is approved by the FDA and is currently used to     treat breast cancer might also work to treat VS. This study will measure the amount of drug     that travels from the bloodstream and arrives at the tumor. This drug is safe and has few     side effects. If this drug is shown to reach the tumor, it might be used in the future to     treat VS without needing surgery or radiation.      This study is recruiting people who are having surgery for VS. If you are going to have     surgery to treat a VS, you may be eligible to participate.   "
232350|NCT00893971|"     The purpose of this study is to evaluate the safety of a single dose of PT003 compared with     single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two     separate single doses in healthy subjects.   "
230462|NCT00863135|"     The purpose of this study is to determine the effects of CPAP treatment on blood pressure in     patients with sleep apnea syndrome (SAS) and refractory arterial hypertension (RAH).      Also, some of the mechanisms mediating SAS and RAH (systemic inflammation, oxidative stress,     sympathetic hyperactivity) will be analyzed.   "
230463|NCT00863148|"     Clofarabine is known to have a stronger anti-tumor effect than Fludarabine and has shown its     efficacy in treating aggressive acute leukemias. In addition, evidence is that it is     well-tolerated with manageable side effects especially in elderly patients. Thus, replacing     Fludarabine with Clofarabine in a reduced intensity transplant regimen may provide a regimen     with increased anti-tumor activity without adding significant risks of toxicity.The purpose     of this study is to evaluate the efficacy and the safety of clofarabine in combination with     IV busulfan and ATG as the backbone of a reduced intensity conditioning regimen for     allogeneic stem cell transplantation for the treatment of patients with high-risk MDS/AML or     ALL not eligible to conventional or standard myeloablative allo-SCT.   "
230464|NCT00863161|"     The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and     leaves the blood in people with normal kidney function or with different degrees of reduced     kidney function.   "
230465|NCT00863174|"     Safety and bioequivalence of SPARC_147709   "
230466|NCT00863187|"     Background:      The ability of the immune system to function declines with aging. This is reflected by a     marked decrease in the responsiveness to vaccinations and to infectious agents.     Consequentially, there is a profound reduction in the quality of live and an increased     dependency on the health systems. Studies have shown that the production of B lymphocytes in     the bone marrow declines with aging and long-lived B cells accumulate in the periphery. Thus,     instead of a juvenile repertoire of B cells that is capable to recognize any new pathogen,     the repertoire of the elderly becomes more restricted and fails to respond to new antigens.      Working hypothesis and aims: We hypothesize that the dramatic change in the cellular     composition in aging reflects homeostasis pressures that are set by long-lived peripheral B     cells. Here, the investigators hypothesize that altering the homeostasis, by active depletion     of the peripheral B cells, will revive B lymphopoiesis in the BM and rejuvenate the     peripheral repertoire of B cells in aging. Consequentially, this will significantly improve     immune responsiveness of aged individuals to new antigenic challenges.      Methods:      The investigators propose a parallel study in human and mouse. For our clinical study we will     use old lymphoma patients that were treated with the B cell depleting therapy, RITUXIMAB, for     transient B cell depletion and established full B cell reconstitution. We will test the     responsiveness of these patients to hepatitis B vaccine and compare it to aged-matched     control group. The investigators will also use old human CD20 transgenic mice where B cell     depletion is imposed by anti human CD20 antibodies. In these experiments we will study     physiological and immunological changes to understand aging mechanisms in the B lineage.      Expected results: We expect that old patients treated for B cell depletion will have an     increased responsiveness to the hepatitis B vaccine relative to the control group.      Importance:      The investigators propose an efficient approach to improve immune response in the elderly     population. This will increase efficacy of vaccination, reduce morbidity and improve quality     of life. It will also reduce the cost of medical treatment. In addition, this study will show     that senescence in the B lineage can be reversed, which is in contrast to the general     concepts of aging.      Probable implications to the welfare and health of the aged population Medicine:      Improving the immune competence will increase efficacy of vaccination, reduce morbidity, and     reduce dependency on health systems. This will significantly improve the quality of life.   "
230467|NCT00863200|"     The goal of this research study is to learn how well a telephone system works for improving     the management of emotional distress, sadness, and/or depression in patients who are being     treated for cancer.   "
230468|NCT00863213|"     The purpose of this study is to compare the effectivity and safety of atrial fibrillation     ablation, in comparison to antiarrhythmic drug therapy in patients with refractory,     persistent atrial fibrillation.   "
230469|NCT00863226|"     The purpose of this study is to see if a device called the Resonator can help to improve     aspects of health and quality of life that are relevant to patients with Parkinson's disease.   "
230471|NCT00863252|"     IgA nephropathy (IgAN) is the commonest primary glomerulonephritis worldwide. In Hong Kong,     IgAN accounts for approximately 30% of all primary glomerular diseases, and a significant     proportion of young patients (< 50 years of age) on dialysis therapy are sufferers of primary     IgAN. To date, no specific therapeutic agent has been consistently shown to halt the     progression of IgAN to end-stage renal failure, particularly in patients with persistent     significant proteinuria and the presence of chronic tubulointerstitial inflammation on kidney     biopsy. In recent years, angiotensin-converting enzyme inhibitors (ACEI) have been found     capable of significantly reducing proteinuria in some IgAN patients, while others,     particularly those with the ACE DD genotype, showed either absent or unsatisfactory response     to angiotensin blockade. Mycophenolate mofetil (MMF) is a marketed immunosuppressive drug     which acts by releasing mycophenolic acid (MPA) to inhibit the de novo pathway of purine     synthesis, and hence is relatively selective for lymphocytes. Apart from being efficacious     for the prophylaxis of renal allograft rejection and for the induction of remission in severe     lupus nephritis, MMF has been anecdotally reported to avert progression to allograft failure     in recurrent IgAN of the transplanted kidney. Data on the clinical efficacy of MMF in the     treatment of primary IgAN, however, is lacking. In the current proposal, we aim to study the     clinical efficacy of MMF in patients with biopsy-proven IgAN and clinically significant     proteinuria despite angiotensin blockade. Patients will be followed up for at least 5 years     to track any survival difference between groups.   "
230472|NCT00863265|"     Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear     to have different mechanisms of action. The investigators hypothesis is that phytosterols and     ezetimibe given together will block cholesterol absorption nearly completely. The     investigators will perform a randomized, placebo-controlled crossover feeding study in 25     subjects with greater than ideal levels of LDL cholesterol who do not require     anti-cholesterol drug treatment. Subjects will consume a baseline diet provided by a feeding     center that is deficient in phytosterols for three periods of 21 days in random order. During     period I placebo phytosterols and placebo ezetimibe will be given; during period II placebo     phytosterols and active ezetimibe will be given; during period III active phytosterols and     active ezetimibe will be given. Study endpoints are fecal cholesterol excretion and percent     cholesterol absorption determined by gas chromatography/mass spectrometry, circulating     phytosterol levels and circulating LDL cholesterol levels.   "
230576|NCT00864656|"     The primary aim of this study is to quantify eyelid position changes in tested and opposite     eyes in ptosis patients submitted to 1, 2 or 4 drops of 10% phenylephrine in one eye. The     secondary objective is to correlate the eye dominance, severity and laterality of ptosis with     eyelid position changes in these 3 groups.   "
252001|NCT01155648|"     The purpose of this study is to compare two physiotherapy techniques: chest wall compression     versus chest wall compression plus increase of 10 cmH2O in inspiratory pressure.   "
230473|NCT00863278|"     Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on     the face. Treatment is difficult and to date the best treatment option is the combination of     hydroquinone, retinoic acid and steroids combined in topical daily application (called     Kligman's trio). Q-switched pigmentary lasers are usually ineffective and can induce post     inflammatory hyperpigmentation (PIH). Intense pulsed light can sometimes improve melasma but     also induce PIH which limit their use. Recently, pulsed dye laser were demonstrated to be     effective in treating some pigmentary defects. Associating blanching cream with hydroquinone     to prevent PIH after laser or intense pulsed light has been already reported with success.      The objective of the study is to compare in a prospective intra individual comparative trial     the association of pulsed dye laser plus stabilized Kligman's trio to Kligman's trio alone.     The secondary objective was to study the frequency and the intensity of the potential side     effects including PIH.   "
230474|NCT00863291|"     The acutely suicidal patient presents a complex and dangerous clinical dilemma. Many suicidal     patients receive antidepressant medications, but the onset of action of these medications is     at least three weeks, and despite their established antidepressant effect, they have not     shown a clear anti-suicidal benefit. Psychoanalysts hypothesized that depression (often     leading to suicidality) shares important characteristics with the psychological sequellae of     object loss and separation distress. Endogenous opioids (endorphines) have been implicated in     mediating social bonding and separation distress in mammals. Anecdotal evidence and several     clinical studies found the mixed opioid agonist-antagonist buprenorphine to be an effective     antidepressant with a rapid onset of action. It is therefore hypothesized that buprenorphine     may be a novel and quick-acting treatment for acute suicidality, especially in the context of     depression. The proposed double-blind study will examine the effect of buprenorphine on     acutely suicidal inpatients. Depression, suicidality, and overall functioning will be     assessed before, during and after a two-week buprenorphine/placebo trial. A small subgroup of     patients will also be treated with short-term psychoanalytic psychotherapy throughout the     study period. It is hypothesized that subjects who receive the active drug will show rapid     improvements in objective and subjective measures of suicidality and depression.   "
230475|NCT00863304|"     Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in     patients with osteoarthritis   "
230476|NCT00863317|"     The primary rationale for this study is to evaluate the effect of once daily montelukast on     duration of acute illness in infants with first-time bronchiolitis.   "
230477|NCT00863330|"     RATIONALE: Treating lymphocytes in the laboratory may help the lymphocytes kill more tumor     cells when they are put back in the body. Aldesleukin may stimulate the lymphocytes to kill     tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving laboratory-treated lymphocytes and aldesleukin together with     cyclophosphamide and fludarabine may kill more tumor cells.      PURPOSE: This phase II trial is studying how well laboratory-treated autologous lymphocytes     and aldesleukin work when given after cyclophosphamide and fludarabine in treating patients     with metastatic melanoma.   "
230478|NCT00863343|"     The primary objective of this study is to evaluate the performance of the MSD® Influenza Test     in detecting influenza A and influenza B in subjects presenting with influenza-like-illness     (ILI).   "
230503|NCT00863694|"     Elevated fecal calprotectin is a biomarker for intestinal inflammation in cystic fibrosis   "
230479|NCT00863356|"     Purpose:      This study is a prospective clinical trial to investigate the efficacy of a chitosan-coated     nasal packing (ChitoFlex® used in conjunction with the HemCon Nasal Plug) in the management     of difficult spontaneous epistaxis and to evaluate its healing effect on nasal mucosa.      The introduction of products that enhances hemostasis can have clinical advantages when     associated with traditional nasal packing. These advantages include a better hemostatic     control and the reduction of nasal packing duration. Furthermore, this study will help     determine if there are any non-desirable effects that chitosan may have on the nasal cavity,     such as the production of fibrosis and foreign body reaction.   "
230480|NCT00863369|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer     growth in different ways. Some block the ability of cancer cells to grow and spread. Others     find cancer cells and help kill them or carry cancer-killing substances to them. Giving     bortezomib together with gemcitabine hydrochloride and rituximab may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib and     gemcitabine hydrochloride when given together with rituximab and to see how well they work in     treating patients with progressive or relapsed B-cell non-Hodgkin lymphoma.   "
230481|NCT00863382|"     Ablation of atrial fibrillation is a well established treatment method to restore normal     sinus rhythm and eliminate the need for continued antiarrhythmic therapy and anticoagulation.     Absence of symptomatic and asymptomatic atrial fibrillation should be considered necessary     for discontinuation of anticoagulation therapy. Presently, recurrence of atrial fibrillation     is usually determined with the use of a non looping event monitor which is typically used by     the subject at the time of symptomatic arrhythmia. This method does not detect asymptomatic     atrial fibrillation. Random asymptomatic recording can be added, but the chance for detecting     recurrence of arrhythmia is not great. Too frequently, the success rates of AF ablation     procedures are inflated by insufficient follow up and patient's limited compliance in     reporting and recording episodes of recurrent arrhythmias. Often times, it is very     inconvenient for patients to wear external event recorders. Allergies to the sticky pads that     are needed for most of the external monitoring devices continues to be a problem. Implantable     loop recorders have the advantage of detecting symptomatic and asymptomatic atrial     fibrillation continuously. They also offer the convenience of monitoring for up to 18 to 24     months without significant patient discomfort. However, implantation and explantation of     these devices involves a limited surgical procedure as well as considerable experience. In     this study we attempt to assess the differences in these two types of monitoring systems in     assessing the long term efficacy of AF ablation.   "
230482|NCT00863395|"     The purpose of this study is to define the mechanisms that underlie the refractory pruritus     (itch) in Cutaneous T-Cell Lymphoma (CTCL).   "
230483|NCT00863408|"     Background:        -  P. falciparum, one of the most virulent forms of malaria, causes more than 300 million          episodes of malaria and 1 million deaths each year. The spread of drug-resistant          parasites, insecticide-resistant mosquitoes, and persistent socioeconomic conditions of          poverty compound the difficulties of malaria as a major global health problem. New means          of disease and vector control are vitally needed.        -  Several promising strategies rely on targeting mosquito populations when they are most          vulnerable, such as during the dry season when mosquitoes find it difficult to          reproduce. Large regions of the West African country of Mali have prolonged dry seasons          (up to 8 months), during which mosquito populations dramatically decline within a month          after the rainfall ceases. Clearly, mosquitoes can survive the dry season (as evident          from their robust numbers during the wet season) but the process that enables them to do          so remains unknown. Targeting the small and fragile mosquito population at the end of          the dry season could reduce or eliminate the numbers of mosquitoes in certain regions,          providing great benefits for communities in dry regions.      Objectives:        -  To determine if common malaria-carrying mosquitoes survive the dry season in the Mali          village of Thierola by estivation (going dormant, or hibernating, during dry periods).        -  To identify and examine mosquitoes that were marked with special paint during a previous          protocol, if these marked mosquitoes are captured during the investigation.      Eligibility:        -  All activities in this protocol will take place in Thierola village, Banamba district,          Koulikoro region, Mall, West Africa. The village was chosen because it is isolated from          other communities by at least 6 km and is a small community of less than 300 inhabitants          living in 90 houses.        -  Participants will be healthy adult men between 18 and 65 years of age.      Design:        -  Thirty adult men who live in Thierola will be recruited to participate as mosquito          collectors for the human-baited trapping method and will work in teams of two.        -  The first collector will expose his lower legs to attract human-seeking mosquitoes.          Using a mouth aspirator, the second collector will collect the mosquitoes as they land          on the first collector's legs.        -  The collections will be conducted both indoors and outdoors from 6 p.m. to 6 a.m. the          following morning for 14 consecutive days.        -  All study volunteers will be trained in proper collection technique and supervised          throughout the study by a mobile team led by the study investigators. Volunteers will be          monitored for signs of malaria and treated accordingly if they develop symptoms of the          disease.        -  Researchers will collect mosquito samples at the end of the dry season (April-May) and          at the start of the rainy season (May-June).        -  Mosquitoes collected in the study will be analyzed by NIH researchers to learn more          about how they survive during the dry season.   "
230484|NCT00863421|"     Only few prospective studies systematically investigated the prevalence of sleep disordered     breathing in patients with stable chronic heart failure. Furthermore there is no report on     the incidence rate of sleep disordered breathing in this population. This is a prospective     multi-centre study of sleep-disordered breathing in 200 patients with stable     moderate-to-severe chronic heart failure. Eligible patients will undergo overnight full-night     polysomnography, lung function testing, laboratory measurements, and hemodynamic recordings.     Measurements will be repeated at 6 months interval for a follow-up period of two years     irrespective of the presence or absence of sleep disordered breathing. The primary outcome     variable for this study is the prevalence of sleep disordered breathing in the study     population. Secondary outcome variables include the 2-year incidence rate of sleep disordered     breathing, quality of life measurements, exercise capacity, sleep quality, hemodynamic     measurements, and laboratory markers of neurohumoral activation, systemic inflammation, and     endothelial function in the study population.   "
230485|NCT00863434|"     RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving clofarabine together with cytarabine may kill more cancer cells.      PURPOSE: This pilot phase II trial is studying how well giving clofarabine together with     cytarabine works in treating patients with acute myeloid leukemia with minimal residual     disease   "
230486|NCT00863460|"     Purpose of the study :      To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their     respective toxicity on the CNS.   "
230487|NCT00863473|"     1. Do a standardized surgical treatment of unstable displaced proximal humerus fracture in          patients aged over 60 compared to a standardized conservative treatment gain a better          functional outcome after one year?        2. Do surgical treatment gain more QALY than conservative treatment after one year?   "
230488|NCT00863499|"     The aim of the iSPOT-A study is to:        1. identify brain, genetic and cognitive markers of Attention Deficit/Hyperactivity          Disorder, and        2. identify brain, genetic and cognitive markers that predict treatment response to          short-acting methylphenidate in children and adolescents diagnosed with Attention          Deficit/Hyperactivity Disorder.   "
230489|NCT00863512|"     RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel,     gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Sometimes after     surgery, the tumor may not need more treatment until it progresses. In this case, observation     may be sufficient. It is not yet known whether chemotherapy is more effective than     observation in treating patients who have undergone surgery for stage I non-small cell lung     cancer.      PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how     well they work compared with observation in treating patients with early stage non-small cell     lung cancer.   "
230490|NCT00863525|"     This study will assess the safety and tolerability of single doses of odanacatib (MK0822)     when administered with a light breakfast.   "
230491|NCT00863538|"     To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with     SCD   "
230504|NCT00863707|"     This study is intended to assess the safety and tolerance of regadenoson in subjects with     renal impairment.   "
230492|NCT00863551|"     This study evaluates the penetration through the blood-brain-barrier of trospium chloride at     plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium     levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured.     Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change     index to assess if any study subject shows evidence of a clinically and statistically     significant change in memory.   "
230493|NCT00863564|"     The purpose of this study is to determine the effects of dietary protein on blood lipids and     gut hormones after a fat-rich meal.      Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream     following a fat rich meal. The effect is dependant of both the quality and the quantity of     protein ingested.   "
230494|NCT00863577|"     The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa     activity   "
230495|NCT00863590|"     This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib     (MK0822) with and without food.   "
230496|NCT00863603|"     Many grafts placed for dialysis access fail which causes patients to undergo additional     operations, decreases their quality of life, and increases health care costs. The purpose of     this study is to see if dialysis access grafts will function longer for patients who receive     additional oxygen by means of a nasal cannula for 42 days after placement of their graft.      Patients will have periodic blood tests to measure oxygen levels in their blood. A series of     ultrasound examinations of patient's dialysis grafts will be taken to ensure the graft is     open and to measure the cellular proliferation (intimal hyperplasia) for comparison in those     receiving extra oxygen and those with no oxygen.   "
230497|NCT00863616|"     Patients with Chronic obstructive pulmonary disease (COPD) tend to have cough, excess mucus     production and breathlessness as cardinal features. The excess mucus production often leads     to frequent infections, exacerbations and poor quality of life. Mucociliary clearance may     have an impact on improving symptoms, exercise tolerance, quality of life and reduce     exacerbations.      High frequency chest wall oscillation(HFCWO) devices use percussion to the chest wall     delivered from a pump through a close fitting inflatable vest. This technique has been shown     to enhance mucus clearance in patients with cystic fibrosis and Bronchiectasis. This pilot     study was designed to explore the feasibility, tolerance and effectiveness of the HFCWO in     patients with advanced COPD.   "
230511|NCT00863811|"     Elevated intraocular pressure is still the main risk factor for development and progression     of glaucoma. Several drugs exist on the market that may decrease IOP in glaucomatous     patients. However, some patients cannot reach the target pressure despite a multitherapy with     a combination of drugs, and are therefore addressed to surgical treatments. Forskolin is a     natural compound that is a receptor-independent adenyl-cyclase activator, that increases     intracellular cAMP. It has been shown to be able to decrease IOP after topical application,     by a mechanism that is not used by the other drugs. Aim of the present study is to see     whether oral administration of a food supplement containing forskolin (KRONEK) has any effect     on the IOP of POAG patients with stable IOP obtained by treatment with either beta-blockers     or prostaglandins.   "
230498|NCT00863629|"     Objectives. The investigators analysed the effects of tight glycemic control in regenerative     potential of the myocardium during acute myocardial infarction (AMI).      Background. A strict glycemic control after AMI improves the cardiac outcome. The role of     tight glycemic control in regenerative potential of the myocardium during acute myocardial     ischemia are still largely unknown.      Methods. Sixty-five patients with first AMI undergoing coronary bypass surgery were studied:     25 normoglycemic patients served as control group; hyperglycemic patients (glucose >140     mg/dl) were randomized to intensive glycemic control (IGC, n=20; glucose goal 80-140 mg/dl)     or conventional glycemic control (CGC, n=20; glucose goal180-200 mg/dl) for almost 3 days     before surgery, using insulin infusion followed by subcutaneous insulin treatment.     Echocardiographic parameters were investigated at admission and after treatment period.     During surgery, oxidative stress (nitrotyrosine, O2- production), apoptosis (Caspase-3) and     cardiac stem cells (CSCs) (c-kit, MDR1 and Sca-1 positive cells) were analysed in biopsy     specimens taken from the peri-infarcted area.   "
230499|NCT00863642|"     While there exists consensus among surgeons that patients with gallstone pancreatitis should     undergo cholecystectomy to prevent recurrence, the precise timing of laparoscopic     cholecystectomy for mild to moderate disease remains controversial. We hypothesize that     laparoscopic cholecystectomy performed within 48 hours of admission, regardless of resolution     of abdominal pain or abnormal laboratory values, will result in a shorter hospital stay.   "
230500|NCT00863655|"     There are no treatments specifically approved after recurrence or progression on a non     steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for     postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study     is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane +     placebo in postmenopausal women with estrogen receptor positive locally advanced or     metastatic breast cancer refractory to NSAI.   "
230501|NCT00863668|"     The reduction with antiretroviral therapy (ART) of HIV RNA in blood, and HIV RNA in infected     cells and in viruses associated with the follicular dendritic cell (FDC) network in lymphatic     tissues, typically follows a two-phase pattern of decline. The half-life of the first-phase     is about 1 day and that of the second phase is about 14 days, with comparable estimates for     first-phase decay in SIV-infected rhesus macaques.      While substantial evidence supports the current view that first-phase decay reflects the     death of activated CD4+ T cells infected before ART was begun, the sources of viral RNA in     the second phase have not as yet been conclusively established. Possible sources of viral RNA     that have been invoked in mathematical models, or for which there is experimental evidence,     include longer-lived infected cells such as macrophages and resting CD4+ T cells,     dissociation of virus from the FDC network, and productively infected CD4+ T cells that are     not subject to clearance by host immune responses because of waning levels of HIV antigen.      Raltegravir (MK-0518) belongs to a new class of integrase inhibitors that potently suppress     HIV and SIV replication, and reportedly markedly alters the second phase HIV decline in a way     that challenges the current view that longer-lived infected cells are the source of virus in     this phase. While mathematical modeling of decay of HIV RNA in blood was most consistent with     1) cells newly infected by long-lived cells, or 2) from activation of latently infected cells     with full-length unintegrated HIV DNA as a source of second phase virus, we think the data     are also quite consistent with the greater efficacy of integrase inhibitors in a particular     cell type and/or anatomic site such as the gut.      In this protocol we will test the hypothesis that the rapid decrease in HIV replication     associated with raltegravir is due to a more complete suppression of viral replication in     lymphatic compartments such as lymph nodes and gastrointestinal lymphatic tissue. We will     also investigate compartment-specific intracellular levels of raltegravir to potentially     explain differences in changes in these compartments.   "
230502|NCT00863681|"     Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934)     will be asked to participate in this long term extension study with BAY63-2521.   "
230506|NCT00863746|"     The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition     to the non-cancer treatments patients would normally receive) is an effective treatment for     lung cancer compared to best supportive care alone. The safety and tolerability of the two     treatment groups will also be compared. The goal of the study is to test the ability of     sorafenib to improve survival compared to best supportive care alone.   "
230507|NCT00863759|"     Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified     anterior and posterior aspherical surface (Akreos AO, Bausch & Lomb,Inc) results in reduced     ocular aberrations (spherical aberration) and in improved contrast sensitivity after cataract     surgery.      Study hypothesis: the implantation of an intraocular lens (IOL) with a modified anterior and     posterior aspherical surface (Akreos AO, Bausch & Lomb,Inc) results in reduced ocular     aberrations (spherical aberration) and improved contrast sensitivity after cataract surgery.      Setting: Department of ophthalmology, Hospital das Clínicas, University of São Paulo, São     Paulo, Brazil.      Overall Study design: This will be an intraindividual randomized double-blinded prospective     study. Patients will be randomized to receive an aspheric IOL Akreos AO in one eye (25 eyes;     Bausch & Lomb, Inc), and an spheric IOL Akreos Fit (25 eyes; Bausch & Lomb, Inc.) in the     fellow eye. Ocular aberrations with a 5.0 mm and 6.0 mm pupil will be measured with a dynamic     retinoscopy aberrometer after 1 and 3 months. Uncorrected and best-corrected visual acuity,     out-focus performance and contrast sensitivity under mesopic and photopic conditions will be     also measured. All patients will be followed for 3 months.   "
230508|NCT00863772|"     Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted     in sensory nerves.   "
230509|NCT00863785|"     35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6     months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter     more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by     administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C)     could make the hepatocytes more resistant and improve survival. The investigators' study's     primary endpoint was improvement of survival at 6 months. The secondary endpoints were     survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7   "
230510|NCT00863798|"     The primary purpose of this study is to compare the antidepressant efficacy and safety of two     doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major     Depressive Disorder. The study will also assess changes in sexual function and general and     functional quality of life outcomes.   "
230512|NCT00863824|"     The purpose of the study is to investigate how long it takes for NNAL and cotinine, both     specific markers of second hand tobacco smoke exposure to clear the human body.   "
230513|NCT00863837|"     BACKGROUND: Previous studies showed that the combination of endoscopic therapy with     vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in     achieving the successful hemostatsis of acute variceal bleeding. The rationale of using     vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy. Nowadays,     endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as     the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage.     EVL alone can achieve hemotasis up to 97% even in cases of active variceal hemorrhage.     However, early rebleeding due to ligation-induced ulcer may be encountered. It appears that     prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical     than using a vasoconstrictor after cessation of bleeding by EVL.      Thus, the investigators designed a controlled trial to compare the initial hemostasis, early     rebleeding rate in cirrhotic patients presenting with acute variceal bleeding receiving     either emergency EVL plus vasoconstrictor infusion or losec infusion for 5 days.   "
230514|NCT00863850|"     An Open-Label Study to Investigate the Pharmacokinetics of Bendamustine Hydrochloride in     Patients With Relapsed or Refractory Malignancy (Hematologic or Nonhematologic)   "
230515|NCT00863863|"     To compare the rate and extent of absorption of griseofulvin from a test formulation of     Griseofulvin 125 mg/5 mL Suspension versus the reference Grifulvin V® 125 mg/5 mL Suspension     under fed conditions.   "
230516|NCT00863876|"     Comparison of repeated WaveLight Analyzer and Alcon LadarWave measurements in phakic and     pseudophakic eyes.   "
230517|NCT00863889|"     The objective of this study is to conduct a randomized, single-blinded placebo controlled     trial comparing two modalities for the treatment of pain and mobility associated with     trochanteric bursitis: (1) injection of glucocorticosteroid and local anesthetic, (2)     injection of local anesthetic. We hope to determine whether steroid injections provide a     statistically significant improvement in pain symptoms and hip mobility in subjects with     trochanteric bursitis, as compared to an injection of local anesthetic. Our null hypothesis     is that no statistically significant difference exists between the two treatment modalities.   "
230518|NCT00863902|"     To determine the pharmacokinetics and bioequivalence of cetirizine hydrochloride formulations     after administration of single doses to normal healthy subjects under fed conditions. These     data were to be evaluated statistically to determine if the products meet bioequivalence     criteria.   "
230519|NCT00863915|"     To compare the rate of absorption and oral bioavailability of a test formulation of     Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral     dose of the commercially available reference product Atlace® manufactured by Monarch     Pharmaceuticals Inc. administrated as a sprinkle on one tablespoonful of applesauce to     healthy subjects after a 10-hour overnight fast   "
230520|NCT00863928|"     This study is evaluating the effect of a Belladonna and Opium suppository administered     intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate     cancer. This is a blinded randomized study. 50% of patients will receive the suppository, 50%     of patients will not. Neither you or your surgeon will know which group you are in.   "
230521|NCT00863941|"     To compare the rate and extent of absorption of Abrika Bupropion 150 mg XL Tablet to that of     Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in fasted subjects.   "
230522|NCT00863954|"     The purpose of this study is to see if using a device called the Resonator, that puts out a     very low electromagnetic field, effects blood glucose and A1c levels in people with Type 2     Diabetes.   "
230523|NCT00863967|"     Arteriosclerosis is a common chronic disease with well known risk factors like diabetes     mellitus, hypertension, dyslipidemia, adipositas and smoking, leading to severe complications     like myocardial infarction, stroke or peripheral arterial occlusive disease. In addition to     life-style factors there is also a genetic predisposition to develop complicated     atherosclerosis.      Objective: Improve individual risk prediction by clinical phenotyping and genotyping.   "
230524|NCT00863980|"     This study is aimed to investigate whether treatment with Telmisartan is more effective than     Candesartan in reducing the ischemic cardiovascular events in high-risk patients with     cardiovascular disease.   "
230525|NCT00863993|"     The aim of this study is to assess whether activity thermogenesis increases in patients     undergoing bariatric surgery post-operatively compared to pre-operatively. The investigators     will assess non-exercise activity thermogenesis using a validated Physical Activity     Monitoring System and doubly labeled water, immediately pre-operatively and again at 6 and 18     months post-operatively. PAMS has been validated in lean and obese individuals. This is to     assess energy expenditure, activity thermogenesis and NEAT during the phase of greatest     weight loss and once weight loss has plateaued. This will permit us to address our primary     hypothesis that activity thermogenesis as a fraction of total daily energy expenditure     increases in patients undergoing bariatric surgery 6 and 18 months post-operatively, compared     to pre-operatively.   "
230526|NCT00864006|"     The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG     delayed release tablets.   "
230527|NCT00864019|"     To compare the rate of absorption and oral bioavailability of a test formulation of     Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent     oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer     Inc. Following an overnight fast of at least 10 hours, subjects will consume a standard     high-calorie, high-fat breakfast meal. This standard breakfast will begin 30 minutes prior to     each dose.   "
230571|NCT00864591|"     This study is designed to determine the diagnostic value of adenosine cardiac magnetic     resonance (CMR) when compared with SPECT.      The investigators hypothesized that adenosine CMR could detect ischemia and is not inferior     to SPECT imaging. In addition stress adenosine cardiac MRI offers a one stop shop enabling     evaluation of cardiac function, rest and stress perfusion and viability.   "
230572|NCT00864604|"     The purpose of this study is to evaluate the relative bioavailability of two formulations of     nabumetone tablets to establish their average bioequivalence   "
230573|NCT00864617|"     The purpose of this study is compare the relative bioavailability of Nifedipine ER tablets 60     mg by Abrica Pharmaceuticals LLLP with that of ADALAT® CC Extended Release Tablets 60 mg by     Bayer Pharmaceuticals Corporation, Bayer HealthCare following a single oral dose (1 x 60 mg     tablet) in healthy adult volunteers under non-fasting conditions   "
230528|NCT00864032|"     Patients will receive neoadjuvant sorafenib (investigational agent) in combination with     preoperative external beam conformal radiotherapy (50 Gy in 25 fractions) for localized,     large soft tissue sarcomas of the extremity and body wall prior to resection with curative     intent. Sorafenib is an FDA-approved targeted agent for patients with renal cell carcinoma     and hepatocellular carcinoma. Preliminary data suggest activity for sorafenib against soft     tissue sarcoma in the metastatic setting. Limited data are available regarding the safety and     efficacy of sorafenib in combination with radiotherapy.      The Phase I portion of the trial will seek to establish the safety of sorafenib and     radiotherapy in the neoadjuvant setting for soft tissue sarcomas of the extremity and body     wall. The Phase II portion of the trial will aim to determine the pathologic     near-complete/complete response rate (≥ 95% tumor necrosis) of this multimodality therapy.     Molecular and dynamic contrast-enhanced MRI studies will seek to establish correlative     biological and imaging markers of response and/or resistance to this therapy.   "
230529|NCT00864045|"     The purpose of this study is to assess the efficacy and safety of sertindole in patients with     schizophrenia in Asia.   "
230530|NCT00864058|"     To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of     NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under fasting     conditions   "
230531|NCT00864071|"     To compare the rate and extent of absorption of griseofulvin from a test formulation of     Griseofulvin 125 mg/5 mL Suspension versus the reference Grifulvin V® 125 mg/5 mL Suspension     under fasting conditions.   "
230532|NCT00864084|"     The purpose of this study is to determine whether participation in pulmonary rehabilitation     improves balance in people with respiratory disease.   "
230533|NCT00864097|"     The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab     added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently     experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.   "
230534|NCT00864110|"     This is a multi-center Phase 1 b study designed to expand the patient safety using     99mTc-EC-DG with SPECT/CT imaging and to expand the patient radiation dosimetry and     pharmacokinetic database using 99mTc-EC-DG in patients who have non-incisional biopsy     definitive evidence of Non-small Cell Lung Cancer as compared to 18F-FDG PET/CT imaging.   "
230535|NCT00864123|"     Cognitive-behavioral therapy (CBT) has proven efficacy for treatment of pediatric     obsessive-compulsive disorder (OCD). Yet, CBT does not help all children and those who     benefit often remain symptomatic upon treatment completion. Recent clinical trials in adults     with other anxiety disorders (acrophobia and social phobia) provided support for using a     medication called D-Cycloserine (DCS) to enahnce the outcome of exposure-based psychotherapy.     Given this, DCS may augment CBT in youth with OCD, an anxiety disorder that is conceptually     similar to acrophobia. With this in mind, the investigators are conducting a randomized,     double-blind placebo controlled pilot study of DCS to determine whether it had any short-term     clinical benefits on CBT in youth with OCD. Forty children and adolescents (ages 8-17) with a     primary diagnosis of OCD will be screened and, should they meet relevant criteria, randomly     assigned to one of two treatment conditions: (1) CBT plus DCS, or (2) CBT plus placebo. All     patients will receive 10 sessions of CBT A rater will assess participants at 3 separate time     points.   "
230679|NCT00873197|"     This study has been designed to investigate the pharmacokinetic and safety profile of the     co-administration of intravenous (IV) and transdermal granisetron, as well as characterise     the pharmacokinetics of multiple transdermal dosing.   "
230536|NCT00864136|"     The aim of this prospective, non-interventional post-marketing surveillance study is to     obtain data on safety and efficacy of Mirena in treatment of prolonged or heavy menstrual     bleeding (Menorrhagia) under daily-life treatment conditions.      It is planned to conduct the study in about 10 countries with a total of 1000 patients. In     several countries, a comparator group will also be documented.      For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12     months will be documented by the treating physician on the case report form. Observations     include the patient's demographic parameters (date of birth, height, weight, race and smoking     habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline     menstruation, result of insertion, concomitant medications and diseases as well as     menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment     including number of weeks until improvement and reduction of menstrual bleeding with respect     to duration and severity, and patient's satisfaction.   "
230537|NCT00864149|"     To compare the rate and extent of absorption of carvedilol from a test formulation of     Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fed conditions.   "
230538|NCT00864162|"     To compare the rate of absorption and oral bioavailability of a test formulation of     Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral     dose of the commercially available reference product Atlace® manufactured by Monarch     Pharmaceuticals Inc. administrated to healthy subjects after a 10-hour overnight fast     followed by a high-calorie, high-fat breakfast meal.   "
230539|NCT00864175|"     This is a single arm, modified dose escalation, open label trial with the objectives of: (1)     Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel     (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab     and docetaxel.   "
230540|NCT00864188|"     The aim of this study is to test if probiotics administered to healthy female subjects in a     dairy format have any skin health benefits.   "
230541|NCT00864201|"     The primary objectives of this exploratory study are to evaluate the effects of bosentan on     hemodynamics (via cardiac catheterization) during exercise in patients with Pulmonary     Arterial Hypertension (PAH) who have abnormal hemodynamics during exercise but normal     hemodynamics at rest. The authors hypothesize that early treatment may change the course of     disease progression by improving hemodynamics during exercise, thus delaying disease     progression.   "
230574|NCT00864630|"     The investigators seek to determine whether brain imaging techniques can be used to help     detect depression, assess its severity, and/or monitor or predict responses to treatment.     Subjects with minor or major depression will be randomly assigned to a wait-list control     group or to treatment with a new computer-based cognitive behavior therapy developed by Dr.     James Cartriene. Brain imaging will be performed before and during treatment using both     magnetic resonance imaging (MRI) and near-infrared spectroscopy (NIRS). The investigators     hypothesize that brain activity, particularly in the lateral frontal areas of the brain, will     provide biomarkers for depression, depression severity, and treatment response.   "
230542|NCT00864214|"     Bioidentical compounded hormone therapy (BCHT) is considered a 'safer' option to the     conventional hormones (HT) by its proponents. However, there is limited research data to     support their claims. Our group at the Women's Health Clinic, in collaboration with the     Departments of Endocrinology, Complementary Medicine and Laboratory Medicine, is interested     in developing a line of research to test the safety and efficacy of BCHT. In the present     study, we aim to find the dose of BCHT that is bioequivalent to conventional HT, in a     randomized, blinded, four-arm, phase I clinical trial. We will estimate the levels of estrone     (E1), estradiol (E2) and estriol (E3) at baseline and at steady state with two-weeks of     administration of three commonly used doses of bioidentical compounded estrogen cream (Biest)     and a standard dose conventional estrogen patch (Vivelle-Dot). E1, E2, and E3 values will be     summarized using point estimates and 95% confidence intervals. Two-sample t-test will be used     to compare each Biest group to the Vivelle-Dot group. Healthy postmenopausal women, with no     contraindications for hormone use, who are able to fully understand and participate in the     trial, will be enrolled. We will utilize the resources of Mayo CRU to conduct this study.   "
230543|NCT00864227|"     A bone marrow transplant, which is a type of stem cell transplant, is a treatment option for     people with leukemia or lymphoma. Recently, stem cell transplants using umbilical cord blood     have become a treatment option for people with these types of cancers. This study will     evaluate the effectiveness of a stem cell transplant using umbilical cord blood, along with     lower doses of chemotherapy, to treat people with leukemia or lymphoma.   "
230544|NCT00864240|"     To determine the dose-response relationship for Clobex TM (clobetasol propionate) Lotion,     0.05%. This information will be used to estimate the ED50, D1, D2 parameters for use in a     full bioequivalence study.   "
230545|NCT00864253|"     The main purpose of this research study is to compare the safety, tolerability, and anti     tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with     metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new     preparation of the active drug paclitaxel. It contains the same medication as the     prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment     of metastatic breast cancer after failure of combination chemotherapy for metastatic disease     or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for     the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy     for people who have not yet had any cancer treatment for the diagnosis of metastatic     melanoma.   "
230546|NCT00864266|"     The primary aim of the study is to identify a predictive molecular signature for response to     chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by     studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs)     by using high throughput techniques.   "
230547|NCT00864279|"     To determine the pharmacokinetics and bioequivalence of cetirizine hydrochloride formulations     after administration of single doses to normal healthy subjects under fasted conditions.     These data were to be evaluated statistically to determine if the products meet     bioequivalence criteria.   "
230680|NCT00873210|"     Objective of this study is to increase knowledge about safety, tolerability, quality of life     and efficacy under conditions of routine use of sunitinib.   "
230548|NCT00864292|"     Patients will be followed every 6 months for a total of 5 visits (Month 0, 6, 12, 18 and 24).     The first visit is the screening and entry visit which can occur at any time after the     subject finishes SEARCH 001 study but preferably it should occur approximately 6 months after     SEARCH 001 study completion.      At each visit, patients will undergo the following        1. Assessment of function including activity of daily living questionnaire        2. History of medical illnesses, medication history        3. Neurological examination: All patients will have a neurological evaluation and          neuropsychological evaluation to characterize neurocognitive and neurological status.          (It is possible that patients within the non-dementia group will meet criteria for          dementia after close testing is completed).        4. Neuropsychological assessment:        5. Thai Depression Inventory.        6. HIV viral load and storage of blood for proviral DNA level      Final outcome assessment based on all available data. If possible, it is intended that these     diagnoses will be determined through monthly VTC conference calls with UH investigators. This     consensus conference will include the Thai investigators, the UH neurologist, the UH     neuropsychologist and the UH principal investigators.   "
230549|NCT00864305|"     To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of     NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting     conditions, and to compare the differences in plasma levels after dosing the test formulation     with and without food   "
230550|NCT00864318|"     Not randomized, multicentric, national phase II trial estimating the efficacy of an     intensification protocol in patients with refractory germ cell tumors with relapse and bad     prognosis.      Treatment consists in two Paclitaxel and Ifosfamide intensification cycles followed by three     Carboplatine and Etoposide high dose cycles. The point is the individual Carboplatine     adjustment to take into account inter-individual patients variability.      This adaptation allow to control each patient plasmatic exposition to avoid both inacceptable     toxicities (such as ear toxicity) and a low exposition losing then the benefit of this high     dose protocol.   "
230551|NCT00864331|"     Primary objectives of the study are:      To assess the differences in survival of the two treatment options in both stage III (A and     B) nonsmall cell lung cancer (NSCLC) (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study     B), respectively      Secondary objectives are:      To assess the differences in toxicity of two treatment options in both stage III (A and B)     NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), and To assess the     differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study     A and Study B   "
230552|NCT00864344|"     To compare the rate of absorption and oral bioavailability of a test formulation of     Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent     oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer     Inc. administrated to healthy subjects after a 10-ghour overnight fast   "
230553|NCT00864357|"     To compare the relative bioavailability of oxycodone HCl 5 mg / ibuprofen 400 mg tablets     (Actavis Elizabeth LLC, Lot No. PI-1565) with that of COMBONOX® tablets (Forest     Pharmaceuticals, Inc., Lot No. 010550) in healthy adult volunteers under non-fasting     conditions.   "
230575|NCT00864643|"     The purpose of this study is to determine the efficacy of lapaquistat acetate, once daily     (QD), coadministered with a statin to lower lipid levels in Subjects with     Hypercholesterolemia.   "
230554|NCT00864370|"     Very little is known about the impact of pregnancy and the postpartum period on BPD. As a     result, the investigators have little evidence on which to base treatment guidelines. The     main goal of this study is to help fill this gap by finding the risk factors for BPD relapse     during pregnancy and the postpartum period.      The risk factors that the investigators will study include:        1. the severity of illness in the past        2. the type and severity of both recent and past stressors        3. any treatments received during pregnancy and the postpartum period.      Other goals of the study are:        1. to see what effect, if any, illness or any medicines taken during pregnancy have on the          baby's well-being at delivery        2. to see how pregnancy alters the way the body clears any medicines taken for BPD        3. to see how much of these medicines babies are exposed to during pregnancy or          breast-feeding.      The investigators believe that the information gathered in this study will lead to new     treatment guidelines for BPD during pregnancy and the postpartum period that will improve     outcomes for pregnant women with BPD and their babies.   "
230555|NCT00864383|"     REMoxTB is a study for the Rapid Evaluation of Moxifloxacin in the treatment of sputum smear     positive tuberculosis. REMoxTB aims to find and evaluate new drugs and regimens that shorten     the duration of tuberculosis therapy.      The purpose of REMoxTB is to evaluate the efficacy, safety and acceptability of two     moxifloxacin-containing treatment combinations to determine whether substituting ethambutol     with moxifloxacin in one combination, and/or substituting isoniazid with moxifloxacin in     another combination, makes it possible to reduce the duration of treatment for TB.   "
230556|NCT00864396|"     The purpose of this study is to determine whether treatment with twice-daily Lansoprazole     30mg (Prevacid 30mg) and behavioral modifications for reflux is superior to treatment with     behavioral modifications for reflux alone in the treatment of laryngopharyngeal reflux (LPR).   "
230557|NCT00864409|"     High-volume infiltration analgesia may be effective in postoperative pain management     following total hip arthroplasty. In this randomized, double-blind trial patients undergoing     bilateral hip arthoplasty are randomized to receive high-volume local anesthetic infiltration     in one hip and similar infiltration with saline (placebo) in the other hip.   "
230558|NCT00864422|"     The motor cortex of the brain changes following chronic pain and injury, and this is linked     to pain-associated changes in motor behaviour. This study aimed to investigate whether     therapeutic exercises in patients with chronic pain can induce reorganisation of the motor     cortex and restore normal motor behaviour. The investigators hypothesised that motor training     can induce reorganisation of the motor cortex and that these changes are related to improved     motor behaviour.   "
230559|NCT00864435|"     To compare the rate and extent of absorption of carvedilol from a test formulation of     Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fasting     conditions.   "
230681|NCT00873223|"     This trial is conducted in the United States. The aim of this clinical trial is to     investigate whether chronic liraglutide administration affects the mode of action     (pharmacokinetics) of insulin detemir   "
230560|NCT00864448|"     To compare the rate of absorption and oral bioavailability of a test formulation of     Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral     dose of the commercially available reference product Atlace® manufactured by Monarch     Pharmaceuticals Inc. administrated to healthy subjects after a 10-hour overnight fast   "
230561|NCT00864461|"     The aim of this study is to assess the frequency of metabolic syndrome in Down syndrome     patients because the prevalence of diabetes mellitus and obesity is higher in individuals     with Down syndrome than in the general population.   "
230562|NCT00864474|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
230563|NCT00864487|"     The purpose of this study is to examine whether co-administration of rifampin with neratinib     has an effect on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or     excretes) of neratinib.   "
230564|NCT00864500|"     To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05%     lotions in asymptomatic subjects.   "
230565|NCT00864513|"     This study is for patients with pancreatic cancer that has grown and/or spread after having     previously received the standard chemotherapy drug called gemcitabine.      In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for     use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps     pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will     receive pemetrexed IV once every 21 days until disease progression or unacceptable side     effects occur.   "
230566|NCT00864526|"     To compare the relative bioavailability of oxycodone HCl 5 mg / ibuprofen 400 mg tablets     (Actavis Elizabeth LLC, Lot No. PI-1565) with that of COMBONOX® tablets (Forest     Pharmaceuticals, Inc., Lot No. 010550) in healthy adult volunteers under fasting conditions.   "
230567|NCT00864539|"     This study is conducted in two phases. At the first phase, the prevalence of vitamin D     insufficiency in primary school-children in Tehran is determined during the cold seasons of     2008. Then, the efficacy of calcium-vitamin D-fortified milk, -orange juice and supplement is     compared in six selected primary schools.   "
230568|NCT00864552|"     To evaluate long-term safety (primarily by recording adverse events including inhibitors),     efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or     on demand.      To evaluate both safety and efficacy with respect to lot variability, in particular regarding     lot-groups formulated with or without fix between.   "
230569|NCT00864565|"     To compare the rate and extent of absorption of fentanyl 25 μg/h transdermal system (test)     and Duragesic (reference) administrated as 1 x 25 μg/h single transdermal system application.   "
230570|NCT00864578|"     Elevated intraocular pressure is still the main risk factor for development and progression     of glaucoma. Several drugs exist on the market that may decrease IOP in glaucomatous     patients. However, some patients cannot reach the target pressure despite a multitherapy with     a combination of drugs, and are therefore addressed to surgical treatments. Forskolin is a     natural compound that is a receptor-independent adenyl-cyclase activator, that increases     intracellular cAMP. It has been shown to be able to decrease IOP after topical application,     by a mechanism that is not used by the other drugs. Aim of the present study is to see     whether a food supplement containing forskolin (KRONEK) has any effect on the IOP of POAG     patients that cannot reach their target pressure, and are therefore on the waiting list for     surgical intervention.   "
230577|NCT00864669|"     The purpose of this study is to compare the relative bioavailability of 500 mg Metformin     Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co. with that of 500 mg     CLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 500     mg extended-release tablet) in healthy adult volunteers under non-fasting conditions.   "
230578|NCT00864682|"     Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics     have been shown to attenuate this response in some patients. This randomized, double-blind,     placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be     superior to lidocaine administered directly into the vein, under tourniquet control, prior to     injection of propofol. Both groups are expected to be superior to placebo.   "
230579|NCT00864695|"     Descriptive analytic survey of 1137 and 518 patients aged 16 years or more before and after     anesthesia exposure, respectively to assess the anesthesiologist-patient relationship role on     patient postoperative perception of the binominal anesthesia-anesthesiologist. The aim of     this study was to assess the anesthesiologist-patient relationship role on patient     postoperative perception of the binominal anesthesia-anesthesiologist.      Period: may/2007 to may/2008   "
230580|NCT00864708|"     The purpose of the study is to investigate new Technology for recovery of ankle walking     function after stroke.   "
230581|NCT00871845|"     The purpose of this study is to determine whether obese people do not respond to hepatitis C     treatment as well as lean people. This research studies whether obese people will show higher     sustained virologic response rate if they lose weight by Orlistat use and dietary and     lifestyle modification.   "
230582|NCT00871858|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.     Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. It is     not yet known whether anastrozole is more effective than fulvestrant before surgery and     radiation therapy in treating patients with breast cancer.      PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works     compared with fulvestrant in treating postmenopausal patients with breast cancer.   "
230583|NCT00871871|"     This study will measure and compare changes in insulin production and sensitivity using the     hyperglycemic clamp technique in obese patients with impaired glucose tolerance and     hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide     (HCTZ).   "
230634|NCT00872599|"     The hypothesis is to test to see if the drug fenofibrate will increase important chemicals in     the body and specifically in the kidney, help to rid the body of salt by the kidneys,     decrease blood pressure and improve insulin sensitivity during high-salt intake in     individuals with hypertension.   "
230584|NCT00871884|"     This study is designed to investigate factors that are associated with prolonged recovery     from mild head injury. The investigators are particularly interested in defining the impact     of anxiety related variables, such as health anxiety and anxiety sensitivity in the     maintenance of symptoms.      A further goal of the study is the evaluation of two treatment methods that have been     proposed to be effective in reducing the impact of post concussion symptoms. The     investigators hypothesize that a treatment which is directly focused on changing these     anxiety related variables will be more effective than one that does not.   "
230585|NCT00871897|"     People with heart failure may experience problems with cognitive function, including memory     and attention. Cardiac rehabilitation, which is an individualized program for heart failure     patients that aims to improve their heart health, may also improve cognitive function. This     study will examine the relationship between heart failure and cognitive function and how     undergoing cardiac rehabilitation affects cognitive function in older adults with heart     failure.   "
230586|NCT00871910|"     Part 1 and Part 2 of this trial will evaluate the safety, tolerability, maximum administered     dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2 hour     intravenous (IV) infusion (Part 1), and as an 8-hour or 24-hour IV infusion (Part 2). Each     3-week period is considered one treatment cycle. Part 3 of this trial will evaluate the     effect of coadministration of antiemetic drug aprepitant on the pharmacokinetics of SCH     727965 administered as a 2 hour IV infusion once every 3 weeks.   "
230587|NCT00871923|"     The goal of this clinical research study is to learn whether Tarceva (erlotinib     hydrochloride), when given in addition to whole brain radiation therapy, is better to treat     brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC).   "
230588|NCT00871936|"     The purpose of this study is to determine whether SLx-4090 in combination with metformin     therapy will reduce HbA1c in patients with Type 2 Diabetes more effectively than metformin     therapy alone.   "
230589|NCT00871949|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     PNU-100480 (PF-02341272) after a single dose in healthy adult volunteers.   "
230590|NCT00871962|"     The purpose of this prospective cohort study is to determine factors involved in survival in     new COPD patients treated by long-term oxygen therapy.      Background: long-term oxygen therapy is indicated in patients with severe COPD. No studies     have been performed in the past 20-25 years to examine the results of early clinical trials.     Further studies are necessary to understand the utility of oxygen therapy in severe COPD.   "
230591|NCT00871975|"     The purpose of this evaluation is to validate the previous clinical study results using a     Near-Infrared Spectroscopy (NIRS) device, as compared to the conventional urodynamics (UDS)     testing. The experiment will use the commercially available Tetra-NIRS and Laborie UDS     equipment.      The hypothesis is that the Tetra-NIRS device, in the clinical environment, provides data to     enhance the analysis using the standard urodynamics equipment (stand-alone Urodynamic     procedure).   "
230592|NCT00872001|"     The purpose of this study is to determine whether acadesine is effective in reducing the     cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG     surgery.   "
230593|NCT00872014|"     The purpose of this study is to determine whether AMG 386, in combination with Sorafenib, is     effective in the treatment of advanced or inoperable Hepatocellular cancer in subjects who     have not received any prior systemic therapy except surgery or locoregional therapy.      Disease status and disease progression will be assessed every 8 weeks. Subjects will remain     on treatment until: progressive disease by RECIST criteria; clinical progression; death or     loss to follow-up; or withdrawal of informed consent.   "
230594|NCT00872027|"     This study will determine the effectiveness of antidepressant medication in preventing     depression and improving recovery in people who have been supported by mechanical ventilators     in an intensive care unit (ICU).   "
230595|NCT00872040|"     Pregnancy and delivery have a major impact on couple's inter personal relationship. Different     modes of delivery have different effect on pelvic floor function, and it is known that     instrumental vaginal deliveries have the worse effect, though various common anatomical     injuries have been described following vaginal delivery. Pelvic floor dysfunction has the     potential to ameliorate sexual function, and the investigators hypothesis is that the impact     of delivery on pelvic floor disorders following delivery will have a direct effect on sexual     malfunction and interpersonal relationship. The purpose of this study is to evaluate the     effect of delivery mode of primiparous women on inter couple relationship , their sexual     function and the female pelvic floor activity. The couples will be followed from the second     trimester of the pregnancy by validated specific questionnaires, assessing the couple's     satisfaction of their marriage, intimacy in their relationship, their sexual behavior and     pelvic floor function. After delivery, the parameters of the parturition will be recorded,     and the couples will be interviewed 6 months following delivery. Apart from questionnaires,     sample of the participated women will be assessed by ultrasound examination of the pelvic     floor.   "
230596|NCT00872053|"     The primary aim of this study is to:        1. Collect pilot data on the effect of task-specific lower extremity training using the          Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop;        2. Collect pilot data on the use of combination therapy on improving gait in subjects with          MS. This therapy will use both Anklebot training and robot-assisted gait training.      Hypothesis: Both trainings will result in improved walking performance, but the combination     therapy will result in greater gains than ankle training alone.   "
230597|NCT00872066|"     The purpose of this study is to monitor the performance of artificial hip joints implanted     with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients     with hip joint disease requiring a total hip replacement. Patients who enter the study will     be randomly allocated to SmartSet® HV or SmartSet® GHV and will be evaluated at regular     intervals following hip surgery using patient, clinical and x-ray assessments   "
230644|NCT00872729|"     Cystinosis is an inheritable disease that if untreated, results in kidney failure as early as     the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate)     which must be taken every six hours for the rest of the patient's life to prevent     complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being     studied to see if it may be able to be given less frequently, once every 12 hours, and have     similar results.   "
230598|NCT00872079|"     This study will create a computer program that can be used to help dose a drug called     warfarin for the prevention of blood clotting. The study will collected specific information     about those patients receiving this drug and use that information to create a computer     program that will predict the effects of the drug. With this prediction program in place, the     investigators can perform a series of what if I gave this amount of drug simulations to     determine the best dose of drug for that patient. Once the computer programs are developed,     the investigators will test the program in patients that actually need this drug. They will     also include genetic information into the prediction since it has been shown that this     information can affect how well the drug works. Patients will have this genetic information     determined during this study.   "
230599|NCT00872092|"     Normally the gastrointestinal tract is only sparsely colonized with bacteria. The normal     flora of the duodenal or jejunal aspirate contains no more than 10^5 bacteria per milliliter.     Small bowel bacterial overgrowth (SBBO) is defined as a pathologically increased number of     bacteria or the presence of colonic flora in the proximal intestine. The reasons for this     condition are manifold, ranging from diabetic neuropathy to surgical bypass. SBBO is frequent     in elderly people. Therapy is targeted at correcting the underlying small bowel abnormalities     that predispose to the condition and at providing appropriate antibiotic therapy. The     symptoms and signs of SBBO can be reversed with this approach. However, in many patients the     conditions predisposing to SBBO persist life-long, once present. This suggests that     noninvasive, sensitive diagnostic tools with high specificity are required. Bacterial culture     of upper intestinal content is considered the diagnostic gold standard. However, since     endoscopic harvesting of duodenal or jejunal fluid is difficult and invasive, indirect tests     such as breath tests have been advocated as diagnostic tools. Hydrogen breath tests are     commonly employed since the substrates can be easily obtained and the measurement is simple.     Hydrogen is formed when carbohydrates are fermented in the intestine. Breath hydrogen     analysis allows a separation of metabolic activity of the intestinal flora from that of the     host, since no known hydrogen production occurs in mammalian tissue. The hydrogen breath test     most often used in routine clinical practice uses glucose. However, the utility of this test     is mostly limited by its low sensitivity, because there are nonproducers in up to 25% of     the subjects tested. The investigators have developed a stable isotope breath test using     13C-labeled lactose-ureide. Glycosyl-ureides are condensation products of reducing sugars and     urea in aqueous acid. Lactose-[13C]ureide has been used to investigate oro-caecal transit     time because it resists digestion by small intestinal enzymes and is hydrolyzed by bacterial     enzymes in the large intestine. A number of studies have described the use of this substrate     in adults and children. The aim of the present study was to investigate the     lactose-[13C]ureide breath test in subjects with suspected SBBO and to compare its results     with the results of the glucose hydrogen breath test. Microbiological analyses of upper     intestinal bacterial cultures were used as gold standard to identify SBBO.   "
230600|NCT00872105|"     This is a multicentre randomized clinical trial prospectively comparing operative treatment     versus conservative (nonoperative) care in the management of displaced distal (Type II)     clavicle fractures.   "
230601|NCT00872118|"     The purpose of this study is to develop and test a new brief intervention to reduce heavy     drinking and social anxiety in college drinkers.   "
230602|NCT00872131|"     This study will attempt to identify gene and brain activity markers that predict whether     people with social anxiety disorder will respond to selective serotonin reuptake inhibitor     medications.   "
230603|NCT00872144|"     Chemotherapy is often used to treat cancer and in many cases can cure it or extend life.     Unfortunately many of the chemotherapeutic agents used in treating cancer can cause nerve     damage, resulting in severe pain involving the extremities. This neuropathic pain causes     significant suffering in cancer survivors and may also limit the amount of chemotherapy     patients are able to tolerate in attempting to treat the cancer. There is evidence that     cannabinoids can suppress chemotherapy evoked neuropathy in animal models, in some cases     better than morphine. This study proposes to examine the effect of a cannabinoid extract     (Sativex) in treatment of neuropathic pain caused by chemotherapy.   "
230604|NCT00872157|"     The goal of this clinical research study is find the highest tolerable dose of BMTP-11 when     given to patients with prostate cancer that has spread. The safety of this drug will also be     studied.   "
230605|NCT00872170|"     Thalassemia is an inherited blood disorder that can result in mild to severe anemia. Many     people with thalassemia also have pulmonary hypertension, which is high blood pressure in the     arteries in the lungs. This study will evaluate the safety and effectiveness of the     medication sildenafil at reducing blood pressure in the lungs of people with thalassemia and     pulmonary hypertension.   "
230782|NCT00874549|"     Safety:      To describe the rates of immediate reactions, solicited injection-site and systemic     reactions, all unsolicited adverse events, and serious adverse events following vaccination     with either Menactra® vaccine or Menomune® vaccine.      Immunogenicity:      To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study     groups.   "
230606|NCT00872183|"     Background:        -  Techniques that teach finger movements are commonly used to explore how humans learn to          move. Researchers have designed a simple, new method of learning finger movements, which          will be explored for the first time in this study. The method is based on how          individuals mimic other people's movements.        -  Previous studies have shown that a brain protein called brain-derived neurotrophic          factor (BDNF) may be important in movement and in learning. There are normal variations          in the gene for BDNF. As an optional component, this study will also look at whether          these gene variations are associated with differences in movement learning.      Objectives:        -  To compare the new motor learning technique with a classic technique to test its          usefulness.        -  To examine whether genetic variations have an effect on motor learning.      Eligibility:        -  Healthy volunteers between the ages of 18 and 50, who are right-handed.      Design:        -  The study will involve two visits to the National Institutes of Health Clinical Center.        -  Visit 1: Medical and neurologic examination to determine whether the volunteer is          eligible to participate further in the study. This screening visit will take about 1          hour.        -  Visit 2: Volunteers will perform a motor learning task by interacting with a computer          program. In response to images on the computer monitor, volunteers will press buttons on          the keyboard as quickly and accurately as possible. The motor learning task will last up          to 3 hours.        -  If a volunteer agrees to genetic testing, researchers will also draw blood for study.          Genetic testing is not required to participate in the motor learning parts of the study.   "
230607|NCT00872235|"     This open-label, balanced, randomized, two-treatment, four-period, two-sequence, single dose,     crossover fully replicated study was conducted on fixed-dose combination of quinapril 20 mg     and hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc. (division of Ranbaxy     Laboratories Limited) and Accuretic 20-25 mg tablets of Parke-Davis (division of Pfizer Inc.)     in healthy, adult, human, male, subjects under fed conditions.   "
230645|NCT00872742|"     This study will test the effectiveness of a new behavioral therapy for adults with     trichotillomania (compulsive hair pulling).   "
230608|NCT00872248|"     The restless leg syndromes is a common sensorimotor disorder of unknown cause affecting     approximately 10% of the population. Different literature had different views on the     association between neuraxial anesthesia and the occurrence of restless leg syndrome. Some     reported that spinal anesthesia induced postoperative restless leg syndrome, but other     studies showed that spinal and general anesthesia all two did not cause restless leg     syndrome. A potential difference amongst these studies is that a big difference exists in     surgical types. The investigators proposed that different types of surgery performed     undergoing various anesthesia, and that there is a big difference in original     pathophysiological condition. Therefore, the investigators hypothesized that pregnant women     who have special physical states would have had an association between neuraxial anesthesia     and restless leg syndrome in such patients who received selective cesarean section undergoing     spinal or epidural anesthesia.   "
230609|NCT00872261|"     This study will examine characteristics and behaviors of young women in India and Tanzania to     determine which challenges and opportunities exist for conducting future trials of HIV     prevention treatments.   "
230610|NCT00872274|"     To access the single-dose oral bioequivalence of sumatriptan succinate 100 mg tablet     (containing 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan) of OHM     Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceutical Inc. USA) with IMITREX® 100 mg     tablet (containing 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan) of     GlaxoSmithKline in healthy, adult, male, human subjects under fed condition.   "
230611|NCT00872287|"     The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new     techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision     Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but     there are not any publications to study a possible different pain score in new techniques     versus classic laparoscopic cholecystectomy. In this randomized controlled study the     researchers have investigated the pain scores, the incidence of nausea and vomiting and     analgesics request after the procedure.   "
230612|NCT00872300|"     The purpose of this study is to determine the antitumor activity of PHA-739358 as single     agent IV infusion in adult patients with Multiple Myeloma who have a history of at least 2     previous lines of treatment for the disease.   "
230613|NCT00872313|"     A range of psychological disorders occur in women in the postpartum period. These include     the blues, which occurs in the first days after birth and which is very common and     self-limiting; severe psychoses often associated with mania or bipolar illness, occurring in     the first weeks after birth; and mild to moderate depression, occurring weeks to months after     birth. Studies have been done focused on postpartum psychosis using a retrospective     investigation, which gave only a limited material on the prevalence of psychological     disorders in postpartum women. The investigators hypothesized that different pathways to     psychosis function as the risk factors which may be overlapped, truly independent, mediating,     or moderating, in new mothers who are at high risk and/or during the early period of     delivery. In addition, the investigators purposed that the temporal sequence of biological,     social and demographic variables are also the potential factors contributing to the     development of postpartum psychosis.   "
230614|NCT00872326|"     The aim of this study is to assess the efficacy and safety of autologous transplantation of     bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with     non-revascularizable critical limb ischemia.   "
230615|NCT00872339|"     Thalassemia is an inherited blood disorder that can result in mild to severe anemia. People     with thalassemia often experience pain, but the exact sources and prevalence of pain remain     unknown. This study will examine the prevalence and severity of pain in people with     thalassemia who are treated with regular blood transfusions and people with thalassemia who     are not treated with regular blood transfusions.   "
230616|NCT00872352|"     In the present study we are planning to study electrophysiological changes related to the     dose and time of bortezomib administration in newly diagnosed patients with MM, during the     first months of treatment and 6 months after ending. In addition a possible correlation     between the incidence of BIPN and the subtype of myeloma and other risk factors will be     investigated.   "
230816|NCT00867828|"     The purpose of this study is to evaluate the efficacy of NKO™ softgels in reducing decline of     global cognitive function as measured by the Neuropsychological Test Battery (NTB), in     patients diagnosed with early stage Alzheimer's disease when compared to fish oil and a     placebo after 24 weeks of treatment.   "
230617|NCT00872365|"     At the moment, most of efforts to prevent non-transmissible chronic diseases at population     level have been centered in promoting healthful behaviors like physical activity, consumption     of fruits and vegetables, and discouraging from the consumption of tobacco and alcohol in     adult population, but the results have been little hopeful. In the last years, manifold     studies have indicated the relation between metabolic alterations and of the fetal growth     with the development of non-transmissible chronic diseases in adult age. More recently, it     has been proposed that maternal factors (endothelial function, oxidative stress and     alterations in adipokines) and placental ones (mitochondrial dysfunction) are the precursory     mechanisms of fetal metabolic alterations and of the later development of non-transmissible     chronic diseases. Also, it has been suggested that possibly supplementation with     micronutrients and the physical exercise during the gestation can regulate these maternal and     placental factors. For the reasons just mentioned, it is necessary to clarify if these     proposed factors are related to fetal metabolic alterations and if the supplementation during     the gestation with micronutrients and/or the physical exercise can regulate them, which would     be an early and novel alternative to fortify the prevention of non-transmissible chronic     diseases in the population.      Purpose        1. To evaluate the effect of associated both the maternal and placental metabolic factors          to non-transmissible chronic diseases in newborn.        2. To evaluate the effect of the physical exercise and the complementation with          micronutrients during the pregnancy either in the endothelial function, the levels of          adipokines, the oxidative stress of the mother and the newborn, as in the placental          mitochondrial function and the anthropometry of newborn.   "
230618|NCT00872378|"     The purpose of this study is to describe change in body weight in non-diabetic morbidly obese     patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide or     placebo injections.   "
230619|NCT00872391|"     The purpose of this study is to assess the safety and efficacy of hypofractionated     stereotactic LINAC radiotherapy with 10 fractions at 6 Gy per fraction at the 80% isodose for     the planning target volume (PTV) in patients with uveal melanoma. Patients will be     followed-up for 10 years after radiotherapy regarding local tumor control, visual acuity,     secondary complications and survival.   "
230620|NCT00872404|"     This is an open-label phase II, multicenter study. Eligible patients will receive CP-751,871     in monotherapy (20 mg/kg IV infusion on Day 1 of 3-week cycles). Tumor check-up will be     performed every 6-8 weeks. Treatment will be continued until disease progression or     unacceptable toxicities according to the patient or the investigator.   "
230621|NCT00872417|"     This study will recruit 520 treatment-naive and 150 treatment-experienced patients to take     the first line or second line of antiviral therapy. This study aims to set up a well-trained     clinical and laboratory team in China, to explore the effects and side-effects of the     first-line and the second line of ARV treatment in Chinese HIV/AIDS adult patients, to     investigate the side-effects of ARV drugs, such as hepatotoxicity, lipoatrophy,     cardiovascular influence, to explore the pharmacokinetics/pharmacodynamics (PK/PD) of Chinese     generic ARV regiments and effective drug concentrations and to explore primary and secondary     drug resistance in China and the immune reconstitution characters of long term ARV in Chinese     adult AIDS patients. This study might provide more practical and optimizing prove for the     treatment guideline for resource limited areas.   "
230622|NCT00872430|"     The aim of this study is to evaluate the efficacy and safety of a phytotherapeutic laxative     tea, composed by Pimpinella anisum, Foeniculum vulgare, Sambucus nigra and Cassia     angustifolia, in a randomized crossover placebo-controlled clinical trial in patients with     chronic constipation.   "
230623|NCT00872443|"     Facing the lack of recommandations of Neurology and cardiology societies, the investigators     decided in 2002 some Good Medical Practices to define a specific and precise population for     whom the closure of permeable oval formaen after a first CVA seem to be necessary. Current     survey of these patients after implantation of a prothesis in interauricular septum is     defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an     echocardiography. One year after implantation, the investigators systematically realized a     control by MRI associated to a contrast echography.      In the aim of evaluating the investigators' medical practice, the investigators decided to do     an observational study which will permit us to judge of the interest or lack of interest of     our Good medical practice before the publication of prospective and randomised clinical     studies.   "
230624|NCT00872456|"     The ADHOC Cohort comprised 3044 DM individuals, treated in 47 CHS primary care clinics, that     underwent haptoglobin genotyping between 2 march, 2005 and 26 September 2006. Individuals     were eligible for inclusion if they had DM and were 55 years of age or older. All treatment     decisions, regarding all aspects of care and follow-up of the study participants, remained at     the discretion of the individual's primary care physician, who was blinded to the     individual's Hp type. Hp distribution was: Hp 1-1 285 (9.4%); Hp 2-1 1248 (41.0%); Hp 2-2     1511 (49.6%).      Hypothesis: strict glucose control (HbA1c<7%) reduces the rate of cardiovascular events only     to diabetic patients with the Hp 2-2 phenotype. We also postulated that, since Hp 2-2 DM     individuals are at an increased genetic susceptibility for cardiovascular disease (CVD), this     unique cohort merits an investigation on the associations between various CVD risk variables     and CVD events and establish whether any evident association was dependent of the     individual's Hp type.   "
230625|NCT00872469|"     The WOMAN trial is a large pragmatic randomised double-blind, placebo controlled trial to     quantify the effects of the early administration of tranexamic acid on death, hysterectomy     and other relevant outcomes. 20,000 adult women, after delivery who have clinically diagnosed     postpartum haemorrhage, are eligible if the responsible doctor is for any reason     substantially uncertain whether or not to use an antifibrinolytic agent. Additionally, TWO     nested studies will be conducted in a subset of women trial participants. The first nested     study (ETAC) aims to evaluate the effect of tranexamic acid (TXA) on markers of coagulation     in 400 women randomised to the WOMAN trial. The second nested study (ETAPLAT) aims to     evaluate the haemostatic effect and antithrombotic effect of TXA in 128 women randomised to     the WOMAN trial.   "
230626|NCT00872482|"     This is a randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain     radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases     from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy     of nimotuzumab in combination with WBRT.   "
230627|NCT00872495|"     The purpose of this study is to determine if analysis of DNA and protein material found in     urine will be useful in the detection of urothelial cancer of the bladder and kidney. This     analysis may be helpful to determine if how a particular cancer will act regarding remission     and recurrence   "
230628|NCT00872521|"     The purpose of this study is to determine efficacy of treatment with bortezomib (in     combination with doxorubicin and dexamethasone) in previously untreated patients with     Multiple Myeloma.   "
230629|NCT00872534|"     To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by     assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses     of aspirin (325 mg) in normal healthy volunteers.   "
230630|NCT00872547|"     The purpose of this study is to monitor the performance of a large metal-on-metal bearing     from the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip     resurfacing surgery or a total hip replacement. Patients who enter the study will be     evaluated at regular intervals following hip surgery using patient, clinical and x-ray     assessments.      The Study was terminated with effect from 30th November 2011 following the completion of 2     year follow up assessments for those patients remaining in the study.      Please note that prior to this decision DePuy voluntarily recalled the ASR products on 24     August 2010. Additional information regarding this voluntary recall and the follow-up of     patients affected by the recall can be found at the following links     http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON155761 and     http://www.depuy.com/countries_list.   "
230631|NCT00872560|"     This trial is conducted in Europe. This trial aims to ensure that there is no substantial     clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and     NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.   "
230632|NCT00872573|"     The purpose of this study is to monitor the stability of the C-Stem™ AMT hip within the thigh     bone when used in the treatment of patients with hip joint disease requiring a total hip     replacement. Patients who enter the study will be evaluated at regular intervals following     hip surgery using patient, clinical, standard x-ray assessments and special x-rays which     allow the stability of the implant to be determined.   "
230633|NCT00872586|"     This study is designed to evaluate the additional efficacy and safety of olmesartan     medoxomil/hydrochlorothiazide in the treatment of Chinese patients with mild to moderate     essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil     monotherapy   "
230635|NCT00872612|"     This randomized study investigates two different diagnostic strategies for patients with     suspected pulmonary sarcoidosis stage I/II.      The objective is to assess the role of endosonography (EBUS/ EUS - FNA) in demonstrating     non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB).      Also the researchers investigate the additional value of BAL, in relation to endosonography     and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis.      Thirdly the researchers aim to assess the rate of complications in both the endosonography     and conventional bronchoscopic workup.   "
230636|NCT00872625|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy in higher doses over a shorter period of time may kill more tumor cells and have     fewer side effects. Drugs used in chemotherapy, such as docetaxel, epirubicin,     cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy     when given together with docetaxel followed by standard therapy in treating women with breast     cancer.   "
230637|NCT00872638|"     Aesthetic appearance of repaired incisions is very important to surgical patients. It has     been stated that if the edges of a wound are closed in such a manner that will result in     eversion, or pouting of the edges that the end cosmetic result will be superior when compared     to wound edges that are simply approximated. The purpose of this study is to compare cosmetic     outcomes of incisions that are closed with everted edges to those in which the edges are     simply approximated.   "
230638|NCT00872651|"     Eligible patients will be randomized in a 1.1 ratio to receive Travoprost 0.004%/timolol 0.5%     once daily or Latanoprost 0.005%/Timolol 0.5% once a day for 8 Weeks. The study treatments     will be compared for mean diurnal intraocular pressure (IOP) change from baseline at Week 8.      Safety parameters measured at 4 study visits: ocular signs, visual acuity, dilated fundus,     cardiovascular parameters (blood pressure and pulse), and adverse events.   "
230639|NCT00872664|"     The primary objectives of this study are to compare the serum and skin concentrations of     beta-carotene, lutein, and lycopene in preterm infants fed preterm formulas with mixed     carotenoids to serum concentrations in preterm infants fed preterm formulas with no added     carotenoids and to human milk fed infants.      The secondary objective of this study is to evaluate the effects of dietary carotenoids on     the developing eye. Stages and zones of retinopathy of prematurity (ROP), retinal function,     and retinal characteristics will also be examined.   "
230640|NCT00872677|"     RATIONALE: A culturally sensitive weight loss program for obese African American breast     cancer survivors may be more effective than a standard weight loss program in helping women     lose weight.      PURPOSE: This randomized clinical trial is studying personalized weight loss counseling to     see how well it works in African American women who are breast cancer survivors.   "
230641|NCT00872690|"     The goal of this study is to examine things that make it easy or hard for OEF/OIF veterans     with polytrauma to live independently or do things on their own at home and in the     community.   "
230653|NCT00872859|"     Primary Hypothesis:      1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast     reconstruction      Secondary hypotheses:        1. The complication rates following staged breast reconstruction using Alloderm or          Dermamatrix are higher if the patient requires radiation compared to those who do not          require radiation.        2. Dermal matrix incorporation is not altered in patients requiring radiation compared to          those who do not require radiation.        3. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix      Specific aims:        1. Evaluate the complication rates in women undergoing staged breast reconstruction with          acellular dermal matrix with or without radiation        2. Compare the complication rates between the two types of acellular dermal matrix        3. Evaluate the histologic characteristics of the dermal matrix exposed to radiation          compared to that not exposed to radiation.        4. Compare the rates of incorporation of the dermal substance into surrounding tissues of          those patients undergoing radiation to those not undergoing radiation   "
230833|NCT00868049|"     The aim is to identify differences in the stomatognathic system, mastication and deglutition     functions between obese and normal weight subjects.   "
230642|NCT00872703|"     Cytomegalovirus (CMV) is the largest member of the virus family Herpesviridae that infects     almost all humans at some point in their lives (Ross, 2004). Congenital CMV infection is most     likely to occur when the mother experiences a primary infection during pregnancy, and it is     much less common in cases of reactivation of the disease or infection by a different CMV     strain (Boppana 1999, Endres 2001). The prevalence of congenital CMV infection varies between     0.15-2.2% (Ross 2004, Ross 2006, Malm 2007). While most infants born with congenital CMV     infection are asymptomatic, 10 to 15% show clinical findings at birth (Ross 2004).      It is generally agreed that congenital CMV infection, whether it is symptomatic or not, is a     major risk factor for perceptual deficits. However, its influence on children's future     neuropsychological functioning is less well established. Symptomatic congenital CMV infection     is a major risk factor for poor developmental outcome (Williamson 1982, Kylat 2006, Dollard     2007), but the available data regarding neuropsychological outcome for asymptomatic children     is extremely diverse (Conboy 1986, Ivarson 1997, Kashdan 1998, Temple 2000, Zhang 2007).      We evaluated the neuropsychological outcome of children with congenital cytomegalovirus (CMV)     infection and normal consecutive fetal neurosonographic examinations and determined whether     Magnetic Resonance Imaging (MRI) provided additional information in these cases.   "
230643|NCT00872716|"     The study hypothesis is that quetiapine XR has anxiolytic properties. The study aims to     investigate the putative anxiolytic properties of quetiapine XR in patients with anxiety     disorders. Therefore, in a proof-of-concept design patients with simple phobia will be     selected to investigate specific anxiolytic and antipanic activity during acute anxiety.     Moreover, in a combined fMRI/visual stimulus presentation paradigm activity of fear-network     associated brain structures such as the amygdala will be investigated under treatment with     quetiapine XR or placebo. Additionally, genetic factors potentially mediating anxiolytic     properties of quetiapine will be studied.   "
230646|NCT00872755|"     Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the     surgical management of the majority of patients suffering from gastroesophageal reflux     disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the     immediate postoperative period. This randomized controlled study was scheduled to investigate     the role of the posterior gastropexy, in combination with laparoscopic Nissen fundoplication,     in prevention of paraesophageal herniation and improvement of postoperative results, in     surgical treatment of GERD.   "
230647|NCT00872781|"     The study was conducted as a open-label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover, bioavailability study comparing Quinapril hydrochloride     and Hydrochlorothiazide tablets 20 mg/25 mg of OHM Laboratories Inc (a subsidiary of Ranbaxy     pharmaceuticals Inc) with AccureticTM tablets 20 mg/ 25 mg (containing quinapril     hydrochloride 20 mg and hydrochlorothiazide 25 mg) manufactured by Parke Davis     Pharmaceuticals Limited, Vega Baja, PR 00694, Made in Germany and distributed by Parke-Davis,     Division of Pfizer Inc. NY, NY 10017 in healthy, adult, male, human subjects under fasting     condition.   "
230648|NCT00872794|"     The purpose of this study is to monitor the performance and determine the metal ion release     of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip     resurfacing surgery. Patients who enter the study will be evaluated at regular intervals     following hip surgery using patient, clinical and x-ray assessments. A subset of patients     will also have blood samples taken at regular intervals to allow the metal ion levels to be     determined and undergo scans to allow the bone mineral density of the bone surrounding the     implant to be monitored.      DePuy decided to close this Study in 4Q 2009. The Study was terminated with effect from     November 2010 to allow for the completion of the 5 year follow up assessments.      Please note that subsequent to this decision DePuy voluntarily recalled the ASR products on     24 August 2010. Additional information regarding this voluntary recall and the follow-up of     patients affected by the recall can be found at the following links     http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157 and     http://www.depuy.com/countries_list.   "
230649|NCT00872807|"     The purpose of this study is to evaluate the effectiveness of a life style counseling     programme designed for overweight and obese children and their parents in groups compared to     traditional individual counseling in the pediatric outpatient clinic and the community. The     two interventions are both hospital and community based.   "
230650|NCT00872820|"     This study will compare the effects that two types of behavioral therapy have on brain     function in people with social anxiety disorder.   "
230651|NCT00872833|"     Thalassemia is an inherited blood disorder that can result in mild to severe anemia. Regular     blood transfusions, which refresh the healthy red blood cell supply, are one treatment for     thalassemia. People with thalassemia often experience pain, but the exact source of pain     remains unknown. This study will examine how pain varies during the blood transfusion cycle     in people with thalassemia who are treated with regular blood transfusions.   "
230652|NCT00872846|"     To evaluate the safety and performance of the BALANCE System in treating patients who have     type 2 diabetes and are overweight. Impact on blood glucose levels, weight loss, blood     pressure and other clinical and metabolic parameters will be studied.   "
230668|NCT00873054|"     The investigators main hypothesis is that the stone free rate will be much higher (95%) in     patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to     determine which treatment is safe and prevent less stone recurrence.   "
230669|NCT00873067|"     The aim of this study is to evaluate whether performing complex fractionated atrial     electrograms ablation improves outcomes in persistent or atrial fibrillation ablation.   "
230670|NCT00873080|"     The present study aims to verify the reliability of intra and inter-examiner of angular     measures proposed by SAPO postural assessment software. Methods: 24 subjects were     photographed and three experienced examiners analyzed the images.   "
230654|NCT00872872|"     Three-drug combination of antiretroviral regimens has been used increasingly in HIV-infected     pregnant women worldwide, both for the prevention of mother to child transmission of HIV     (PMTCT) and for women's own health. Use of these drugs in pregnant women solely for PMTCT     means that these drugs will need to be discontinued in the majority of women after delivery.      Certain antiretroviral regimens contain drugs with long half-life (drugs that stay in the     body for a longer period of time after discontinuation than other drugs in the same regimen),     such as nevirapine (NVP). HIV can easily develop resistance to NVP when NVP is the only drug     left in the body (similar to monotherapy). Given two other drugs for up to 1 week after     discontinue NVP (to mimic three-drug regimen while waiting for NVP elimination) can help     reduce, but not eliminate, the development of resistant virus.      Unfortunately, NVP-containing regimens are the most widely used regimens for pregnant women     in developing countries due to its low cost and its availability in fixed-dose combinations.     These study will explore how fast NVP is eliminated from women after delivery and to see if     given zidovudine/lamivudine (AZT/3TC) for 1 or 2 weeks after NVP discontinuation can help     reduce the development of NVP resistant virus.   "
230655|NCT00872885|"     The purpose of the trial is to determine whether the new centrally acting analgesic is     effective in comparison to placebo and an active comparator (morphine).   "
230656|NCT00872898|"     The purpose of this study is to investigate the safety and efficacy of memantine extended     release, as well as its extent of absorption in pediatric patients with autism.   "
230657|NCT00872911|"     The investigators' general hypothesis is that nutritional factors, including protein/energy     malnutrition and/or an impaired response of muscle to nutrition, and inactivity play     significant roles in developing sarcopenia, the involuntary loss of muscle mass and function     with age. Therefore, age-specific prolonged interventions including nutritional manipulations     and/or exercise may help to reduce, stabilize, or even reverse sarcopenia.   "
230658|NCT00872924|"     An open label, bioequivalence study of sumatriptan succinate 100 mg tablets (containing 140     mg of sumatriptan succinate equivalent to 100 mg sumatriptan) under fasting Conditions   "
230678|NCT00873184|"     The purpose of this study is        -  to assess the feasibility and acceptability of massage therapyto examine the effects of          massage therapy        -  to explore whether psychological outcomes are associated with changes in patient          reported QoL.   "
230659|NCT00872937|"     Human papillomavirus (HPV) infection plays a key role in the carcinogenesis of cervical     cancer and pre-invasive lesions. There are hundred types of HPV, including high risk and low     risk types, and it is proved the close association between the cervical cancer and high risk     HPV. While HPV 16 and 18 are known to be the leading two genotypes detected in women with     cervical neoplasm worldwide, there is considerable difference in the other prevalent high     risk genotypes in different geographic areas. It is important to establish the local database     about the cervical intraepithelial lesions and the related prevalent HPV genotypes. The     investigators designed a retrospective study which included total 784 patients managed at our     hospital from January 1, 2000 to December 31, 2007. The present study was to investigate the     HPV genotypes in the Taiwanese female patients with abnormal cervical cytology and analyses     the association between HPV types and cervical pre-invasive lesions. It could provide the     guide for the clinicians in the management of patients with abnormal cytological change of     Pap smear.   "
230660|NCT00872950|"     The purpose of this study is to determine the effectiveness and adverse effects of     3,4-diaminopyridine for the treatment of the Lambert-Eaton Myasthenic Syndrome (LEMS) and     Congenital Myasthenic Syndromes (CMS).   "
230661|NCT00872963|"     Malaria is one of the leading causes of deaths in children below five years old. Despite     antimalarial drugs and insecticide treated bed nets, the established means of treatment and     protection, malaria still continues to affect many children. A malaria vaccine would be a     very effective way of reducing malaria infection in the community. RTS,S/AS01E is a leading     malaria vaccine candidate which is being developed for children in Africa. The investigators     have done a study to find out if this vaccine is effective in reducing infection by malaria     in children aged 5-17 months living in Kenya and Tanzania. The follow up of the original     study was 14-18 months. The extended follow up is proposed to continue for another four     years.   "
230662|NCT00872976|"     The purpose of this study is to determine the recommended dose for the combination of     dasatinib and bendamustine in chronic lymphocytic leukemia (CLL).   "
230663|NCT00872989|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more     effective when given alone or together with vandetanib.      PURPOSE: This randomized phase II trial is studying docetaxel given together with or without     vandetanib to see how well it works in treating patients with persistent or recurrent ovarian     epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.   "
230664|NCT00873002|"     RATIONALE: Panobinostat and sorafenib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Sorafenib may also stop the growth of liver cancer by     blocking blood flow to the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when     given together with sorafenib in treating patients with liver cancer that is metastatic     and/or cannot be removed by surgery.   "
230665|NCT00873015|"     The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and     to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured     cerebral aneurysms.   "
230666|NCT00873028|"     The purpose of this study is to evaluate the effects of a 6-day postoperative in hospital     cardiopulmonary rehabilitation program on inspiratory muscle strength and its potential     association with improved functional capacity after coronary artery bypass grafting surgery.   "
230667|NCT00873041|"     CICL670A2209: This study will evaluate the safety and efficacy of deferasirox in     non-transfusion dependent thalassemia patients with iron overload. Patients will be treated     either with active treatment (deferasirox) or placebo for 12 months (core study phase).     Patients who complete the core study phase will be offered to continue their study with the     active treatment (deferasirox) in a 12 months extension phase. During the core and extension,     the effects of treatment on iron overload in the liver will be evaluated using magnetic     resonance imaging (MRI) assessments.      CICL670A2209E1: A one-year open-label extension to a randomized, double-blind,     placebo-controlled, phase II study to evaluate efficacy and safety of deferasirox in     non-transfusion dependent thalassemia patients with iron overload (Thalassa).   "
230671|NCT00873093|"     This pilot, phase II trial studies the side effects of giving bortezomib together with     combination chemotherapy and to see how well it works in treating young patients with     relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving bortezomib together with combination     chemotherapy may kill more cancer cells.   "
230672|NCT00873106|"     The purpose of the present study is to determine if the retinal thickness estimates of the     Stratus OCT, the 3D OCT-1000, and the CirrusHD OCT are comparable in diabetic and in healthy     individuals (OCT=Optical Coherence Tomography).   "
230673|NCT00873119|"     The purpose of this study is to assess efficacy and safety of belinostat in combination with     carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown     primary.   "
230674|NCT00873132|"     Purpose and Objective:      The purpose of this study is to collect data both retrospectively and prospectively, by     consent, on subjects seen in the PRTBTC. This information will be useful to the investigators     to generate hypotheses for planning further psychosocial and medication intervention studies     that will hopefully improve primary brain tumor patients' QOL.   "
230675|NCT00873145|"     Background:      Bone defects of the distal humerus require complex reconstructions, for which standard     prostheses may be insufficient. The researchers therefore investigated the clinical and     radiological outcome of elbow reconstructions by megaprostheses.   "
230676|NCT00873158|"     The purpose of this study is to compare two treatments for adhesive capsulitis.   "
230677|NCT00873171|"     As a safe and noninvasive method of treatment, the intent of the study is to show that     Osteopathic manipulation therapy is a beneficial treatment for the aggravating bladder     symptoms seen in all patients with interstitial cystitis.   "
230682|NCT00873236|"     RATIONALE: Comparing results of MRI scans done after bevacizumab may help doctors predict a     patient's response to treatment and help plan the best treatment. It is not yet known whether     giving bevacizumab alone is more effective than giving bevacizumab together with interferon     alpha-2a in detecting kidney cancer.      PURPOSE: This randomized phase II trial is studying MRI scans of blood vessel changes caused     by bevacizumab to see how well it works compared with bevacizumab given together with     interferon alpha-2a in treating patients with stage III or stage IV kidney cancer.   "
230683|NCT00873249|"     This study is a 6-month, multicenter, randomized study to assess the effect of daily SMS     reminders sent during 3 months in the adherence to oral antipsychotic treatment in stabilized     outpatients with schizophrenia.   "
230684|NCT00873262|"     The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex     hormones, among women suffering from severe PreMenstrual Syndrome (PMS) and desensitizes them     with the relevant sex hormones in order to reduce PMS symptoms.      The system includes skin testing panel for identification of hormones to which the patients     might be sensitive. Tests are applied close to the ovulation period and the skin reaction is     examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests     and patient's history will determine the eligibility of the patients to enter a     desensitization protocol.      During the desensitization period hormones to which the patient were found sensitive to, are     injected intradermally three times (once a month) within the luteal phase in increasing     doses. The end-point of the study is a statistically significant decrease, or elimination of     PMS symptoms, compared to a solvent group.   "
230685|NCT00873275|"     RATIONALE: Drugs used in chemotherapy, such as ursodiol, oxaliplatin, leucovorin, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the     tumor. Giving ursodiol together with leucovorin calcium, fluorouracil, oxaliplatin, and     bevacizumab may be an effective treatment for colorectal cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of ursodiol when given     together with combination chemotherapy and bevacizumab in treating patients with stage IV     colorectal cancer.   "
230686|NCT00873288|"     RATIONALE: Receiving a reminder letter from their doctor with questions to ask the Cancer     Information Service may be more effective than a standard reminder letter in helping patients     who have had an abnormal Pap test keep their follow-up colposcopy appointment.      PURPOSE: This randomized clinical trial is studying a personalized letter with Cancer     Information Service support to see how well it works compared with a standard reminder letter     in women scheduled for colposcopy after an abnormal Pap test.   "
230687|NCT00873301|"     Women with vulvodynia will fill out a questionnaire and undergo a gynecological examination     before and 6 months after vestibulectomy. The investigators hypothesize that pain will     decrease.   "
230703|NCT00873509|"     The purpose of this study is to evaluate the effects of twice-daily oral buspirone on core     features of autism in autistic children aged 2-6 years as measured by the change from     baseline in the Autism Diagnostic Observation Schedule (ADOS) Composite Total scores compared     to placebo at 6 months.   "
230688|NCT00873314|"     The aim of the pilot trial is to assess at what extend women with arrested threatened preterm     labor change their activity patterns at home in response to bed rest prescription.      An area of concern for the design of a trial is the strength of health provider's     recommendation to change women's behaviors, and their compliance with bed rest     recommendations. The study was a randomized parallel design. The intervention group consisted     of total bed rest for four days (with allowance to go to the toilet). The control group     consisted in the restriction of activities during four days.   "
230689|NCT00873327|"     This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety     of piperacillin-tazobactam in infants < 61 days of age with suspected sepsis. There will be     four cohorts of 8 infants each:        1. < 32 weeks gestational age (GA) and < 14 days postnatal age (PNA)        2. < 32 weeks gestational age and >=14 days postnatal age        3. >=32 weeks gestational age and < 14 days postnatal age        4. >=32 weeks gestational age and >=14 days postnatal age. The study requires          administration of 6 doses of study drug along with other antimicrobials per standard of          care followed by 1 week of safety monitoring. Four 200 µL pK samples will be obtained at          steady state. The risks are reasonable vs. the benefits and have been minimized          appropriately. There may be benefit to the subjects (administration of broad spectrum          empirical antimicrobial therapy), and information from the study may benefit a large          number of other infants in whom the drug is currently being administered despite the          lack of PK data in this population.   "
230690|NCT00873340|"     To gather Observation data about physical disability progression, safety and adherence during     the use of Betaferon in daily practice. Patients with any type of Multiple Sclerosis (MS)     (MRRS) (PSMS), under treatment with Betaferon.Open Multicentric Observational study.24     months.Evaluation of physical disability in patients treated with Betaferon, using Kurtzke's     expanded disability scale (EDSS) in biannual periods   "
230691|NCT00873353|"     The purpose of this study is to determine efficacy of the treatment with erlotinib in     combination with capecitabine in patients with advanced pancreatic cancer.   "
230692|NCT00873366|"     RATIONALE: A breath test that measures enzymes may be effective in identifying women in whom     tamoxifen may not be effective.      PURPOSE: This clinical trial is studying a breath test to see how well it works in women     receiving tamoxifen for the prevention or treatment of breast cancer.   "
230693|NCT00873379|"     122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a     night of melatonin, half got a placebo.   "
230726|NCT00873808|"     RATIONALE: Gathering information over time from imaging and laboratory tests of women     receiving bisphosphonates for breast cancer may help doctors learn more about long-term bone     quality and plan the best treatment. Tetracycline hydrochloride and demeclocycline     hydrochloride can mark the new growth of the bone, so it may be seen better under a     microscope.      PURPOSE: This clinical trial is studying long-term bone quality in women with breast cancer     enrolled on clinical trial SWOG-S0307.   "
230694|NCT00873392|"     Medical treatment of idiopathic Parkinson disease motor symptoms requires dopaminergic drugs,     with long term disabling side effects. (fluctuations, dyskinesia, ON/OFF phenomena). Use of     nicotine in Parkinson's disease has been suggested by the lowest prevalence of smokers among     Parkinsonian patients. However, controlled studies provided conflicting results. One of our     patients showed a substantial decrease of his parkinsonian symptoms under transdermal     nicotine-therapy. Currently, this patient has been treated since 8 years with an excellent     safety, especially on cardiovascular level. Otherwise, the investigators performed an open     pilot safety and feasibility study in 6 patients, which demonstrated the possibility of a     controlled study. In this study, all patients received daily doses during several months     until 105 mg/day and could, in parallel, decrease their L-Dopa and agonists doses, improving     their motor scores.      The investigators now propose a phase II, controlled, single blind and randomised efficacy     study (n=40) in 2 parallel groups. (1 group transdermal nicotine-therapy / 1 control group     without additional therapy) The main objective is to verify the correlation between UPDRS     (score III) motor score and the administrated nicotine dose. This study will also allow the     evaluation of nicotine neuroprotective effect. The incrementation phase by weekly steps of 5     mg until 20 mg, then 10 mg to reach 90 mg/j or the maximal tolerated dose, will last on 11     weeks and will be followed by a 28 weeks phase at this stable dose. After this maximal dose     plateau phase, treatment will be progressively decreased by 15 mg weekly steps, over a de     6-week period followed by a five-week wash out phase.      Taking into account results from the pilot study, a long-term high doses treatment, seems to     be liable to improve patients who deeply suffer from their disease. This is why the     investigators now propose this monocentric institutional project.   "
230695|NCT00873405|"     Obesity is a multifactorial disease that affects millions of people worldwide. It is the main     independent risk factor for developing type 2 diabetes mellitus (T2DM). Most patients with     T2DM and glucose intolerance (GI) are overweight, a condition known as diabesity. In patients     with the most severe form of obesity, i.e., morbid obesity, the likelihood of developing     diseases associated with obesity is increased.      The investigators currently know that bariatric surgery provides sustained weight loss and     well-documented remission of T2DM. Patients who undergo bariatric surgery show long-term     reduced mortality from coronary artery disease, cancer and diabetes; 136 lives are saved per     10,000 surgical procedures performed. Bariatric surgery is a relatively safe procedure that     is becoming increasingly well-accepted; in 2007, approximately 170,000 bariatric procedures     were performed in the USA. Currently, bariatric surgery is the most effective choice of     treatment of morbidly obese patients with diabetes.      The surgical procedures that are currently performed to treat morbid obesity are divided into     two main groups: gastric restrictive procedures and combination procedures; the latter     combine gastric restriction and malabsorption. The roux-en-Y gastric bypass (RYGB) is the     combination procedure most frequently performed, whereas sleeve gastrectomy (SG) is an     emerging restrictive procedure. SG can be performed as the first of a two-stage operation in     patients at high risk of death, or as a definitive surgical procedure. It has shown good     results with regard to weight loss and glycemic control in various studies. The potential     advantages of SG include lower probability of vitamin and mineral deficiencies because this     procedure has no malabsorptive component; access to the entire intestinal tract; no need for     a subcutaneous access port or adjustments; absence of dumping syndrome and lower probability     of intestinal obstruction. In addition, SG can be performed in patients who have inflammatory     bowel disease or who have undergone bowel surgery, and it can be easily converted into RYGB.     Both SG and RYGB can be performed with or without the placement of a Silastic® ring.      The metabolic control achieved with bariatric procedures has been demonstrated and reproduced     in various medical centers worldwide. Metabolic control can be achieved with gastric     restrictive procedures such as vertical banded gastroplasty, adjustable gastric banding and,     more recently, SG. However, it has been shown that glucose homeostasis is affected by various     intestinal mechanisms observed exclusively in procedures that include a malabsorptive     element, such as RYGB.      A systematic review of 22,094 cases of morbidly obese patients submitted to bariatric surgery     has shown that resolution of T2DM was achieved in 76.8% of the cases, improvement being     achieved in 86% of cases. Among the criteria used to diagnose metabolic syndrome, fasting     glucose levels are the first to return to normal in patients submitted to Silastic® ring     gastric bypass (SRGB), a modification of the traditional RYGB which consists in adding a     Silastic® ring to the gastric bypass operation. Normoglycemia after bariatric procedures, as     well as diabesity itself, is multifactorial. Normoglycemia is observed as a result of dietary     control, decreased plasma levels of ghrelin, weight loss and reduction of body fat, as well     as of the release of gastrointestinal hormones that interfere with the function of pancreatic     β cells (incretins).      The main purpose of this study was to compare the weight loss of morbidly obese patients     submitted to either a Silastic® ring sleeve gastrectomy (SRSG) or an SRGB, as well as to     compare the effects of both procedures on glucose homeostasis in morbidly obese patients.   "
230696|NCT00873418|"     This study will evaluate whether heart failure patients receiving a 16 week telephone     delivered, intervention using cognitive behavior therapy to facilitate self-management of     heart failure will have better clinical outcomes than heart failure patients receiving a 16     week heart failure education intervention via telephone.   "
230697|NCT00873431|"     The main aim of this clinical study is to investigate the safety and tolerability of     different dose strengths of IC47 up to 6 months after the first vaccination.      A total of 32 healthy subjects (male or female) will participate in this clinical study. The     subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47     will be administered three times in intervals of 42 days each.   "
230698|NCT00873444|"     The purpose of this study is to monitor the performance and compare the metal ion release of     two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients     with hip joint disease requiring a total hip replacement. Patients who enter the study will     be randomly allocated to one of the bearing combinations and will be evaluated at regular     intervals using, patient, clinical and x-ray assessments. Patients will also have blood     samples taken at regular intervals to allow the metal ion levels to be determined.   "
230699|NCT00873457|"     Perifosine inhibits the AKT pathway (a way cells communicate with each other). This pathway     is felt to be important in the development of several types of cancers including chronic     lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is thought perifosine may     be able to block this pathway and lead to an improvement in the CLL or SLL. The purpose of     this trial is to see if perifosine is an effective treatment for relapsed or refractory CLL     or SLL. Another purpose of this study is to look at the effect perifosine has on cells.   "
230700|NCT00873470|"     The study consists of the realization of a new esophageal stimulation for patients already     stimulated 10 years ago.      The investigators would like to make a long term evaluation of the evolution of anterograde     effective refractory period of accessory duct in the WPW syndrome.      This study will be realized by esophageal stimulation.   "
230701|NCT00873483|"     Birth Control Patch Study   "
230702|NCT00873496|"     Chronic inflammation that comprises the exocrine glands' function leads to xerophthalmia and     xerostomia in Sjögren's syndrome. The oral consequences range widely and they are related to     decreased salivary output. Hydroxychloroquine may inhibit cholinesterase activity in salivary     glands via interference with antigen processing mechanism, and thus, the investigators'     hypothesis was that salivary gland function may be improved if treated with     hydroxychloroquine. The effects of hydroxychloroquine on the salivary flow rate, subjective     and objective parameters of the patients were also assessed.   "
230704|NCT00873522|"     1. BACKGROUND           Pneumonia occurring outside of the hospital setting is regarded as community acquired          pneumonia. However, pneumonia occurring in non-hospital long-term care facilities          constituted a distinct type of pneumonia from CAP. Kollef et al has justified health          care associated pneumonia (HCAP) as a new category of pneumonia [1]. The HCAP patients          are associated with severe disease, higher mortality rate, and greater length of stay          and increased cost [1]. HCAP are often at risk for multi-drug resistant bacterial          pathogens such as Pseudomonas aeruginosa, extended-spectrum beta-lactamase Klebsiella          pneumoniae, Acinetobacter baumannii, and methicillin-resistant S. aureus (MRSA) [2].           Health care facilities have not been defined in Taiwan. Respiratory care ward (RCW) is a          special unit to take care long-term ventilatory dependent patients in Taiwan. Some of          the patients get pneumonia and are referred back to medical centers. Besides,          community-acquired P. aeruginosa, Acinetobacter baumannii or MRSA have been reported          [3-8]. Therefore, the core-organisms of HCAP in Taiwan might be multi-drug resistant and          the causes of inadequate initial antibiotics treatment. The common pathogens were also          unknown.           Till now, there are no data about the pathogens of HCAP in Taiwan. We define the          health-care facilities and initiate a retrospective study to characterize the          microbiology and clinical outcome of Community acquired pneumonia and          Health-Care-Associated pneumonia in Taiwan. Further analysis will perform to confirm the          differences between CAP an HCAP in Taiwan.        2. Objectives:           I. To characterize CAP and HCAP i. Microbiological epidemiology ii. Disease severity:          PSI iii. Outcome : length of stay, mortality , antimicrobial susceptibility and          treatment outcomes II. To characterize HCAP from RCW i. Microbiological epidemiology ii.          Disease severity: PSI iii. Outcome : length of stay, mortality        3. Study design:      This is a retrospective multi-center cohort study to characterize microbiology, and clinical     outcomes in Taiwan.      Data sources: CAP or HCAP registered in 4 medical centers from Jan 1 2007 to Dec. 31 2007. (2     in north Taiwan, 1 in central Taiwan, 1 in south Taiwan) Expected case number: 800 HCAP and     1800 CAP   "
230705|NCT00873535|"     Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking.     However, very little research has been conducted into the nature of this co-occurrence. Thus,     the main aim of this study is to assess differences in alcohol and tobacco consumption and     cue-induced craving in treatment-seeking smokers after two weeks treatment of varenicline.      Hypotheses        1. Two weeks of varenicline treatment will significantly decrease cue-induced tobacco          craving compared to placebo (Due to the actions of varenicline on alpha-4-beta-2          receptors and its downstream effect on dopamine release).        2. Varenicline will decrease cue-induced alcohol craving compared to placebo.        3. The impact of Varenicline on cue-induced alcohol craving will be greater in heavy          drinkers compared to social drinkers.   "
230706|NCT00873548|"     The primary objective of this prospective multicenter study is to assess any fracture     fixation complication and revision rates during the clinical use of the Proximal Femoral Nail     Antirotation Asia (PFNA Asia) for the treatment of unstable trochanteric fractures.   "
230727|NCT00873821|"     A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo     in subjects with type 2 diabetes who have inadequate control on metformin.   "
230707|NCT00873561|"     This was a study designed to evaluate the efficacy of multiple doses of an investigational     drug, NBI-6024, in adult (18 to 35 years of age) and adolescent (10 to 17 years of age)     patients with new onset type 1 diabetes mellitus, on endogenous insulin production.      A total of 188 patients were enrolled in the study. The study was divided into three periods:     screening, treatment (comprising an induction phase and maintenance phase), and follow-up.      NBI-6024 was generally well tolerated and exhibits a benign safety profile, as there were no     significant safety issues with NBI-6024 treatment. In summary, NBI-6024 did not demonstrate     statistically significant efficacy compared with placebo.   "
230708|NCT00873574|"     The main goal of the study is to progress in our understanding of the molecular basis of     myeloproliferative disorders of the bone marrow (polycythemia vera, essential     thrombocythemia, primary myelofibrosis). The study will focus on the genes encoding factors     implicated in the JAK-STAT pathway which has an essential role in these diseases   "
230709|NCT00873587|"     There are two commonly used methods to remove chest tubes following thoracotomy. One is to     remove the chest tube at maximum inspiration, (patient is asked to take a deep breath in and     hold it), and the other is to pull the chest tube at maximum expiration,(patient is asked to     blow out as much air as they can can and hold it). There has been considerable discussion     among Thoracic surgeons that one of these two methods may decrease the risk of pneumothorax,     the most common complication associated with chest tube removal. The investigators will     compare the two methods, and also identify risk factors of developing pneumothorax during     chest tube removal.   "
230710|NCT00873600|"     RATIONALE: Gathering health information from older patients undergoing chemotherapy may help     doctors plan better treatment and improve the quality of life for these patients.      PURPOSE: This randomized clinical trial is studying how well an outpatient health care     program works for older patients receiving chemotherapy for newly diagnosed breast cancer or     colon cancer.   "
230711|NCT00873613|"     The purpose of this study is to determine if non-dilated retinal photography in the emergency     room improves the diagnosis of papilledema (optic nerve swelling) in patients with neurologic     disease compared to direct ophthalmoscopy.   "
230712|NCT00873626|"     The purpose of this study is to compare the efficacy of 5 days versus 10 days treatment     duration in uncomplicated acute pyelonephritis.      Acute pyelonephritis is a common disease and the treatment duration is not found on     scientific evidence. If a short treatment is equal to standard duration, it will possible to     shortening antibiotherapy with ecologic and economic advantage.   "
230713|NCT00873639|"     This trial is conducted in Europe. The aim of this observational study is to evaluate the     blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin     detemir) after switch from human insulins for treatment of type 1 diabetes under normal     clinical practice conditions in Romania.   "
230714|NCT00873652|"     The UK immunisation guidelines recommend that children immunised with an accelerated course     of hepatitis B vaccine (i.e. vaccination at 0, 1, 2 and 12 months) receive an additional     booster dose of vaccine in later childhood (usually at 3 1/2 years of age). The primary     objective of this study is to to assess what proportion of these children have 'protective'     concentrations (10mIU/ml) of hepatitis B specific antibodies before and after the booster     dose of hepatitis B vaccine.   "
230715|NCT00873665|"     The investigators propose a single-site, prospective randomized trial to determine the     effects of aerobic exercise training on ED among 50 sedentary men undergoing radical     prostatectomy for clinically localized prostate cancer.   "
230716|NCT00873678|"     Primary objective:        -  assessment of the prevalence of AHI1 mutations in Joubert syndrome and          cerebello-oculo-renal syndromes (JS/CORS)      Secondary objective:        -  assessment of the prevalence of CEP290 mutations and NPHP1 homozygous deletions in          JS/CORS        -  caracterization of mutational spectrum of AHI1, NPHP1, CEP290 genes in JS/CORS.        -  evaluation of genotype-phenotype correlation in JS/CORS.   "
230717|NCT00873691|"     The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt     biphasic waveform and the Tuned biphasic waveform in patients with right-sided implants.   "
230719|NCT00873717|"     Elderly persons in long-term facilities often have denutrition, associated with a bad oral     and dental status. Yet, many elderly persons don't attend dentist care and when they have     dental prothesis, do not often use them during meals. The impact of a rehabilitation of     dental function on their nutritional status has not been proven.      The objective of this study is to assess the impact of 2 strategies aimed to restore a good     nutritional status, among patients with slight denutrition.   "
230720|NCT00873730|"     The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg     twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis     (AS) and previous failure to usual practice therapies in Spain.   "
230721|NCT00873743|"     The aim of this study is to evaluate quality of patient-controlled peroral analgesia after     cesarian section using the combination of tramadol and acetaminophen. Research hypothesis is     that the combination reduces pain at leg rising more than tramadol alone.   "
230722|NCT00873756|"     This is a multicenter, open-label study enrolling a total of up to 23 patients.   "
230723|NCT00873769|"     The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg     Staccato Loxapine administered to smokers compared to nonsmokers.   "
230724|NCT00873782|"     Muscular dystrophies are inherited disorders in which the skeletal and heart muscles become     progressively weaker, sometimes leading to permanent disability. Current treatments aim to     control symptoms as much as possible, but there is no cure. Gene therapy, in which defective     genes causing the disorder are corrected, is a potential treatment option and is in the     process of being developed for muscular dystrophies. This study will determine the safety and     feasibility of a particular delivery method for gene therapy that could be used in the future     to treat people with muscular dystrophies. Only normal saline, and no active treatment, will     be used in this study.   "
230725|NCT00873795|"     FDA has accepted atypical antipsychotics of olanzapine and aripiprazole as the adjuvant     medications for refractory major depression. But there is still no trial about atypical     antipsychotics combined with antidepressant of SSRI used in fresh major depressive patients.     This project aims to compare the efficacy and tolerability of sertraline with or without     low-dosed aripiprazole added in fresh major depression.   "
230728|NCT00873834|"     This study is a comparative, double blind, placebo controlled trial of 6-months duration     designed to evaluate 1) the effects of fluoxetine in 5 to 12 years old autistic children, 2)     the effects of fluoxetine on serotoninergic parameters, 3) cerebral metabolic changes (rCBF     measurements with PET) induced by the treatment.   "
230729|NCT00873847|"     This observational study tests the feasibility of enrolling subjects and obtaining an     amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second     aEEG recording between 72-168 hours of life, and weekly thereafter up to 36 weeks     post-menstrual age. It will enroll 85-100 infants between 401-1,000 grams birth weight OR     between 23 0/7 and 28 6/7 weeks gestational age born at the 7 participating NICHD Neonatal     Research Network sites.   "
230730|NCT00873860|"     This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to     evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in     adult subjects with uncontrolled, moderate-to-severe, persistent asthma.   "
230731|NCT00873873|"     Distinct patterns of loss in pulmonary function were identified in children with mild to     moderate asthma participating in a 10-year observation period during the NHLBI Childhood     Asthma Management Program. This loss in pulmonary function is likely related to ongoing     inflammation unresponsive to current therapy. This study will measure indicators of airway     inflammation which are associated with structural and physiologic changes in the lung and     provide insight into mechanisms of asthma progression in adolescence and early adulthood.   "
230732|NCT00873886|"     The primary research question of this study is: Does the pharmacokinetics of oseltamivir     after a single oral dose differ between the pregnant and non-pregnant women?   "
230733|NCT00873899|"     The EVOLVO study is designed to compare the remote defibrillator management to the current     standard of care, to assess its ability to treat and triage patients more effectively.   "
230734|NCT00873912|"     This prospective annual release study was designed to assess the safety of a monovalent     influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not     previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy     adults received a single dose of vaccine or placebo and were followed for 180 days.   "
230735|NCT00873925|"     In this pilot study the investigators are trying to see if a single intravenous infusion of     autologous (self) cord blood cells followed by 1 year of daily vitamin D and omega 3 fatty     acid supplementation can preserve beta cell function (prolong honeymoon) in children with     type 1 diabetes. All subjects will continue to use insulin therapy as needed to maintain the     best possible glucose control.      15 Subjects will be randomized such that 2 of every 3 (10 total) will receive cord blood plus     vitamin D and Omega 3 while 1 of 3 (5 total) will serve as controls and will not receive cord     blood, vitamin D, or Omega 3 supplementation.      The study will involve 5 visits over 1 year to the University of Florida      This study is a follow-up to our initial study of cord blood infusion alone in which 23     children received autologous cord blood. The initial study was 100% safe but additional     studies like the one described above are needed to determine how to improve cord blood based     therapy.   "
230874|NCT00868595|"     This is a Phase I, non-randomized, multiple-dose, 3+3 dose-escalation study of the safety,     pharmacokinetics, biomarkers, preliminary efficacy and patient-reported outcomes of     therapeutic vaccine, BPX-101 (formerly BP-GMAX-CD1), plus activating agent, AP1903, in     patients with castrate resistant prostate cancer.   "
230736|NCT00873938|"     With a change in malaria treatment policy to use combination antimalaria therapy, it is     envisaged that compliance to combination therapy would be less than that of monotherapy that     was being used for case management in Ghana. This is especially so as amodiaquine is     unpopular because of its side-effects and the combination therapy is not a single formulation     (fixed dose). Compliance may further be enhanced by community supervision through home visits     of combination antimalarial therapy in cases of uncomplicated malaria.      This study would assess compliance to Artesunate-Amodiaquine therapy. It would also assess     the effect of compliance to artesunate-amodiaquine therapy on clinical and parasitological     cure rates. This study targeting age groups above ten years, would complement a child     artesunate -amodiaquine efficacy study being undertaken by the same investigators in children     ten years and below at Kintampo District at the same time. The funding for the child study     has been approved by the Gates Malaria Partnership. Findings from both studies, involving all     age groups would be made available to the National Malaria Control Programme and other     stakeholders as practical information that may be beneficial to implementing policy change     process from antimalarial monotherapy to a combination therapy.   "
230737|NCT00873951|"     Hydrolysis of dietary protein may impact their gastrointestinal kinetics and further     metabolism. The primary goal of this work was to measure the metabolic fate of intact or     hydrolyzed protein using a protein of good nutritional quality, i.e., casein. A second aim of     this study was to assess the true ileal digestibility of dietary protein using different     methods including the hydrolyzed casein method and to measure its possible effect on     endogenous intestinal N losses in humans.   "
230738|NCT00873964|"     In the United States cardiovascular disease (CVD) accounts for 1 in every 2.8 deaths and is     the leading cause of death among men and women 65 years or older (1). Studies have shown that     the risk for cardiovascular disease is higher in individuals with the Metabolic Syndrome (2).     Metabolic Syndrome (MBS) is defined by the Adult Treatment Panel III (ATP III) guidelines as     a group of risk factors that includes 3 or more of the following: abdominal obesity,     hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure,     and high fasting glucose (3). These factors place individuals at increased risk for the     development of both cardiovascular disease (CVD) and diabetes mellitus (3). It is commonly     held that insulin resistance is the driving force for the development of the MBS.      Although there is a significant increase in incidence of MBS in the elderly, there are few     studies that specifically examined MBS in that population. The prevailing opinion is that the     strikingly high prevalence of the MBS in the elderly is due to concurrent obesity - i.e., the     population gains weight as it ages, and development of the MBS accompanies the weight gain.      However, while it is true that becoming obese may decrease insulin sensitivity, it has also     been demonstrated that not all obese individuals are insulin resistant. Some studies suggest     that up to 40% of obese individuals demonstrate normal insulin sensitivity (4). In addition,     it is notable that the rate of increasing MBS in the population exceeds that of the rate of     increasing BMI, suggesting that, while BMI may be a modulating factor, another factor     independent of obesity also contributes to the development of MBS in the elderly.      It is the investigators hypothesize that the MBS in the obese elderly population is primarily     linked to insulin resistance and not to obesity per se. The investigators propose to test     this hypothesis by assessing MBS and insulin resistance in a population of obese elderly men     and women and then determining whether or not the MBS tracks with insulin resistance.   "
230739|NCT00873977|"     The purpose of this study is to compare the treatment adherence and effects in three     modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea.   "
230740|NCT00873990|"     The aim of the investigators study is to compare how two different bonding agents affects     retention in a preventive dental procedure of pit and fissure sealant. This study will help     in deciding whether the self etch bonding agent requiring less steps in completion is as     effective as the total etch bonding agent requiring multiple steps in fissure sealant     placement.   "
230741|NCT00874003|"     The purpose of this study is to study the effects of 8 weeks of treatment with mirtazapine on     alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind     placebo controlled clinical trial with parallel group design(N=59).   "
230742|NCT00874016|"     Time to intubate, view to glottic opening and success rate are not different when Airtraq     technique is used compared to standard direct laryngoscopy in children.   "
230743|NCT00874029|"     The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency     ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine     fibroids.   "
230744|NCT00874042|"     This is an open-label, dose-escalation/de-escalation study of ARQ 197 administered orally in     combination with gemcitabine. The study is designed to determine the safety, tolerability and     maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of ARQ 197 when administered     in combination with gemcitabine to patients with advanced solid tumors.   "
230745|NCT00874055|"     Participants will be matched with either their friend or an unfamiliar peer who is the same     gender and about the same age. Participants will have 45 minutes of free-play in an     experimental room where they will have free access to energy-dense and nutrient-dense foods     and an assortment of games and puzzles.      The investigators predict that participants eating with a friend will eat significantly more     than participants eating with an unfamiliar peer. The investigators also predict that     overweight participants eating with an overweight partner will eat significantly more than     participants eating with a non overweight participant.   "
230746|NCT00874068|"     The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant     formula on bone strength parameters.   "
230747|NCT00874094|"     Platelets are a component of blood, which contain factors which can enhance wound healing.     This study proposes to evaluate the clinical response of laugh lines treated with a     concentrated preparation of the subject's own platelets injected into or under the skin by     taking serial photographs of the subject's face over a 12 week period. Also, the same     preparation will be injected into or under the skin of the arm near the elbows, and serial     biopsies will be taken over a 12 week period.   "
230748|NCT00874107|"     The Phase 2 study described in this protocol will serve to evaluate the antitumor activity,     safety and pharmacokinetic profile of Imprime PGG when combined with bevacizumab and     concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced     NSCLC. Additionally, this study will provide guidance for the design of more definitive     efficacy studies of Imprime PGG in NSCLC patients.   "
230749|NCT00874120|"     Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized     on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy     with randomized active or placebo treatment with a subsequent 6-8 day washout period,     followed by a second 7-day period of double-blind therapy with the other agent. Ambulatory     blood pressure measurement will be performed beginning on Day 7 of each treatment period     following administration of the study drug.   "
230750|NCT00874133|"     Diabetes affects 5.8% of the adult population in Israel (1). Gastroparesis is a syndrome     characterized by delayed gastric emptying in the absence of mechanical obstruction of the     stomach.Treatment with acupuncture has been described as effective in improvement of symptoms     in patients with gastroparesis in a number of patient series. However, this treatment     approach has not been tested by means of a controlled randomized clinical study, and neither     has the connection between improvement of symptoms and the anatomical-physiological effect of     the treatment, if ever, assessed.This study will test the efficacy of motilium (20 mg thrice     daily) as compared to acupuncture treatment on the following subjective and objective     parameters of 30 patients with diabetic gastroparesis and impaired glucose control:        1. To compare the degree of GCSI scores improvement before and after treatment with          motilium or acupuncture using a validated questionnaire.        2. To determine the effect of treatment with motilium or acupuncture on gastric emptying          rate.        3. To determine the effect of treatment with motilium or acupuncture on glycemic control.        4. To compare the quality of life before and after treatment with motilium or acupuncture          using the Short Form-36 (SF-36).   "
230751|NCT00874146|"     Primary objective of the study is to evaluate the correlation between level of HER2-neu gene     amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to     progression (TTP) in patients with HER2-positive advanced breast cancer treated with     trastuzumab-containing regimens.   "
230752|NCT00874159|"     This study is conducted in Asia. The aim of this observational study is to describe the     diabetes management, control status and complication profile in a diabetic population of     Philippines.   "
230753|NCT00874172|"     Quality of life of adult patients with sickle cell disease is deeply impaired by severe     adverse medical events that inadvertently occur throughout their time life. Indeed, patients     not presenting a life threatening condition often present to the emergency department with     sickle cell disease crisis related pain. Currently, the effectiveness of specific analgesic     strategies for treating sickle cell disease crisis related pain are mostly based on     acetaminophen and opioid derivates combination along with oxygen delivery. Those strategies     are effective but may last up to half an hour to obtain pain relief. This delay mostly     depends on the availability of venous access and on individual patient response to treatment.     Nitrous oxide is a volatile efficient analgesic therapy that has been repeatedly shown to     allow rapid analgesia in the emergency department setting.      The investigators hypothesise that a new analgesic strategy (rapid optimized analgesic     strategy) including nitrous oxide and nefopam would be as safe and more rapidly effective     than current analgesic strategy.   "
230754|NCT00874185|"     Evaluate satisfaction in people treated with IPDE5 inhibitors over time   "
230755|NCT00874198|"     The purpose of the study is to determine the predictive values and prognostic accuracies of     CSF dynamic measures, the TAP -TEST (high-volume cerebrospinal fluid withdrawal), resistance     to CSF outflow and compliance in the prediction of shunt-treatment outcome in patients with     idiopathic normal pressure hydrocephalus.   "
230756|NCT00874211|"     RATIONALE: Gathering information about how often osteonecrosis of the jaw occurs in patients     receiving zoledronic acid for bone metastases may help doctors learn more about the disease     and provide the best follow-up care.      PURPOSE: This clinical trial is studying osteonecrosis of the jaw in patients with cancer who     are receiving zoledronic acid for bone metastases.   "
230757|NCT00874224|"     The ORANGE II trial is a double blinded randomised controlled trial that will provide     evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic     sectionectomy in terms of time to functional recovery, hospital length of stay, quality of     life, readmission percentage, morbidity and mortality, hospital costs, body image and     cosmesis, and long term incidence of incisional hernias.   "
230758|NCT00874237|"     The purpose of the present Phase 1 study is to assess the cardiac safety of Staccato Loxapine     administered to healthy volunteers in a 3 period crossover study.   "
230759|NCT00874250|"     To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the     primary treatment of aneurysm of the descending thoracic aorta (DTA)      > Primary Hypothesis: The proportion of subjects free from a major device event through 1     month post-treatment will not be significantly less than 0.95, which represents the     proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis   "
230760|NCT00874263|"     The recently developed endoscopic Confocal probe microscopy system allows imaging of surface     epithelium during ongoing endoscopy (upper and lower) with the potential of immediate     diagnosis of various GI pre-malignant and malignant lesions. The purpose of this study is to     determine if using this new Confocal probe system can find pre-cancerous abnormalities in the     stomach and colon.      Hypothesis: The confocal endomicroscopy images of colorectal lesions during the standard     colonoscopies could help the classification in vivo of colorectal neoplastic and     non-neoplastic lesions. This could direct further endoscopic interventions such as targeted     biopsies of early colorectal cancer lesions and the endoscopic resection of such lesions     during screening colonoscopies.      Primary Aim        1. To determine the key confocal image features of neoplastic and pre-neoplastic colorectal          lesions including flat and raised adenomatous polyps, intraepithelial neoplasia and          cancer as well as benign lesions such as hyperplastic polyps and normal colonic          epithelium and to estimate which morphologic features best distinguish neoplastic and          non-neoplastic tissues.           Secondary Aims:        2. To determine the initial sensitivity and specificity of confocal microendoscopy imaging          for classification of adenomatous from hyperplastic polyps of the colon.        3. In this exploratory phase of the study to develop a library of confocal microendoscopic          imaging characteristics of other GI pathologies such as:             1. Barrett's esophagus in comparison to Barrett's esophagus with dysplasia, and normal               squamous esophagus.             2. Other encountered inflammatory and neoplastic conditions within the GI tract in               which biopsy or removal of tissue would routinely be indicated.      The second phase of the study will focus on establishing the sensitivities, specificities,     accuracy of confocal images of colorectal lesions and other GI pathologies as well as     inter-observer agreement and learning curve in interpretation of confocal images.   "
230761|NCT00874276|"     To establish the relationship between human MAAI haplotype and DCA and tyrosine metabolism.     This aim test the postulates that MAAI haplotype determines, and thus can predict,1)     dose-dependent DCA kinetics and biotransformation.   "
230783|NCT00874562|"     This is a research study designed to look at the biological effects of two drugs on leukemia     cells. In this study, we are comparing the effects of drugs called corticosteroids when used     alone or with another drug called rapamycin. Rapamycin is a drug that prevents the body's     immune system from working normally. It has been used for many years after kidney transplants     to prevent rejection of the organ. Recent work suggests that rapamycin may also help treat     leukemia and other cancers.   "
230947|NCT00874965|"     This study was designed to test the following hypothesis:      The benefit of electrostimulation training will be greater than sham stimulation training in     term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of     ventilation during exercise and quality of life in COPD patients   "
230762|NCT00874289|"     Acute decompensated heart failure (ADHF) is the leading cause of admission to hospital in the     US, and is associated with high mortality, morbidity, and major cost to the health care     system. Much of this cost relates to prolonged hospitalizations from acute deterioration in     kidney function (AKI), which in turn is associated with further cardiovascular events such as     recurrent ADHF. Strategies for early detection minimization and prevention of AKI would     therefore be of tremendous benefit to both the patient and the health care system.      A common reason for hospitalization in ADHF is that of altered volume status and renal     impairment. Also, many patients with ADHF have underlying hypertension and/or a recent acute     coronary syndrome. Hypertension, diabetes and chronic kidney disease (CKD) are independent     risk factors for cardiovascular disease, and diabetes is the leading cause of CKD. Therefore,     patients presenting with ADHF are at high risk for CV events, more so if they develop AKI.     Therefore, strategies to detect changes in renal status early may allow for more rapid     intervention with appropriate drug and other therapies to attenuate AKI and subsequent     complications, which may in turn result in prevention of early readmissions with HF.      Most ADHF patients have underlying chronic heart failure (CHF). CHF is a major cost to the     health care system. About two thirds of this cost relates to hospitalization for acute     deterioration in heart failure (HF). Strategies to minimize or prevent HF hospitalization     therefore are of tremendous benefit to both the patient and the health care system.      The most frequent reason for hospitalization in a CHF patient is that of altered volume     status and renal impairment. Therefore, as with ADHF, strategies for early detection of     changes in renal status may allow for intervention with appropriate drug and other therapies     to attenuate, or even prevent, the need for the patient to return to hospital.      Many approaches have been studied in relation to this concept. Deterioration in renal     function is a harbinger of a need for hospitalization, and indeed a predictor of medium term     mortality. However, current measures of renal function are relatively crude with a     considerable lag between an insult to the kidney and its translation to a measurable     deterioration in renal function reflected by worsening serum creatinine. Thus, diagnostic     tests that evaluate renal injury which are modulated early in the time course of this process     may have considerable utility not only in the ADHF setting but also in predicting     decompensation in the CHF setting.   "
230763|NCT00874302|"     Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study     medication for 4 months. This will be followed by a 6 month off-drug interval until there is     a return of significant symptomatology. If they experience symptoms of a certain severity,     the subject will enter a second 4 month treatment cycle and then a follow-up period.   "
230764|NCT00874315|"     RATIONALE: - Relapsed or refractory Neuroblastoma (NBL) carries a very poor prognosis and     children with relapsed NBL have an overall 3 year survival rate of < 10%. Hematopoietic Stem     Cell Transplant from a different donor (allogeneic), is a form of adoptive cellular therapy ,     such that infused donor cells find host tumors as foreign and fight them. After transplant,     the donor immune cells (i.e. T cells, NK cells) mediate Graft versus Tumor (GVT) effect and     may stop tumor from recurring. Also,reduced intensity transplants lead to minimal toxicity     and less risk of mortality in heavily pre-treated NBL patients.      PURPOSE: This phase II trial is studying how well giving a reduced intensity(using     Fludarabine, Busulfan and antithymocyte globulin)preparative regimen followed by donor stem     cell transplant works in treating young patients with high-risk neuroblastoma that has     relapsed or not responded to treatment.   "
230773|NCT00874432|"     The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs     primarily used to treat hypertension or congestive heart failure) to prevent or delay     cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining     their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled     study.   "
230774|NCT00874445|"     The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt     biphasic waveform and the Tuned biphasic waveform in a single coil active can configuration.   "
230765|NCT00874328|"     The irinotecan and cisplatin combination showed significant anti-tumor activity. In the     first-line setting, the investigators showed that this regimen had significant anti-tumor     activity in 47% of chemo-naïve NSCLC patients with 1-year survival rate of 64.2%. Again, the     investigators showed that the second-line Irinotecan and cisplatin is an active and     well-tolerated regimen in patients with advanced NSCLC pretreated with non-platinum based     chemotherapy.      TS-1 (Jeil Pharmaceutical Co.,Ltd, Seoul, Korea) is an oral anticancer drug comprised of     tegafur, 5-chloro-2, 4-dihydroxypyridine and potassium oxonate, in a molar ratio of 1:0.4:1.     Tegafur is a prodrug that generates 5-fluorouracil (5-FU) in blood via metabolism by liver     enzyme, and 5-chloro-2, 4-dihydroxypyridine enhance the serum concentration of 5-FU by the     competitive inhibition of dihydropyrimidine dehydrogenase, an enzyme responsible for 5-FU     catabolism. Potassium oxonate is also a reversible competitive inhibitor of orotate     phosphoribosyl transferase, a phosphoenzyme for 5-FU. Diarrhea induced by 5-FU administration     is though to be attributable to the phosphorylation of 5-FU by the enzyme in the     gastrointestinal tissue. After oral administration of potassium oxonate, the concentration of     potassium in the gastrointestinal tissue is high enough to inhibit the enzyme while the     concentration in blood and tumor is reported to be either slight or nil. Because of these     mechanism, oral TS-1 administration generates a higher concentration of 5-FU than protracted     intravenous infusion of 5-FU given in a dose equimolar to the tegafur in S-1, whereas the     incidence of adverse events concerning the GI tract does not increase. In a phase II trial of     TS-1 as first-line setting in NSCLC, the response rate was 22% and the median survival time     was 10.2 months. As expected, the incidence of severe gastrointestinal adverse events was     low, and so was few severe hematologic toxicity. Recently 3-weekly TS-1 plus cisplatin showed     activity against NSCLC with a response rate of 32.7% and the safety was acceptable.   "
230766|NCT00874341|"     Current evidence indicates that fruit and vegetable intake and dietary patterns rich in fruit     and vegetables may be associated with reduced insulin resistance and may reduce the risk of     the metabolic syndrome. If proven, this relationship may partly explain the inverse     association between fruit and vegetable intake and cardiovascular disease risk. There are     currently no published dietary interventions that have examined in detail the relationship     between fruit and vegetable intake and insulin resistance. There is, however, some     preliminary evidence from whole diet interventions that a diet rich in fruit and vegetables     may have a beneficial effect on insulin resistance. Evidence to date indicates that an     investigation of the direct association between fruit and vegetable intakes and insulin     resistance in a carefully controlled intervention study is warranted. This study will     investigate the dose−response effect of fruit and vegetable intake on insulin resistance in     people who are overweight and at high−risk of CVD using state−of−the−art techniques.   "
230767|NCT00874354|"     This research is being done because currently there is no effective way in regenerating or     replacing the heart muscle that has been damaged after a heart attack.      The purpose of this study is to test whether injecting cells obtained from the patient's bone     marrow into the coronary artery can regenerate and replace heart tissue to strengthen heart     and prevent heart from dilating and developing heart failure.   "
230768|NCT00874367|"     In this observational study, the NICHD Neonatal Research Network (NRN) is conducting     surveillance of all infants born at NRN centers to identify all newborns who are diagnosed     with early-onset sepsis (EOS) and/or meningitis. The study will: establish current     hospital-based rates of EOS among term and preterm infants in the era of intrapartum     antibiotic prophylaxis; monitor the organisms associated with EOS and meningitis; compare     asymptomatic and symptomatic infants by gestational age and pathogen; and monitor     sepsis-associated mortality rates by pathogen group.   "
230769|NCT00874380|"     Our research involves the detailed description of the content of the diet of x dialysis     patients.      For our purpose we used a newly developed food frequency questionnaire. This is the first     validated questionnaire specific for dialysis patients and we were the first to use it.      Our special focus was the fiber content in the diet of our patient. Our thesis that they are     way below the recommended guidelines for fiber intake was verified. Our follow will evaluate     the effect of such at diet, mosTLy cardiovascular.   "
230798|NCT00867594|"     The intent of the proposed study is to assess the potential of oral insulin to mitigate     diabetic instability and reduce the frequency and severity of hypoglycemic episodes in     patients with type 1 diabetes. Restoring hepatic glycogen stores is critical for the     normalization of counter-regulation to hypoglycemia in these patients. Oral insulin can     provide a means to increase portal insulin levels, shift the ratio of insulin/glucagon in     favor of glycogenesis while sparing the patient the risk of hypoglycemia due to peripheral     hyperinsulinemia   "
230770|NCT00874393|"     This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized,     double-blinded study of blood pressure management within 12 months. Eligible infants will     receive an infusion drug (dopamine or a dextrose placebo) and a syringe drug (hydrocortisone     or a normal saline placebo).      Enrolled infants will be randomized to receive one of the following drug pairs:        -  dopamine and hydrocortisone        -  dopamine and normal saline        -  dextrose and hydrocortisone        -  dextrose and normal saline.      In addition to the intervention above, the NRN is conducting a 6-month time-limited     prospective observational study of all infants born at an NRN center between 23 and 26 weeks     gestational age. All clinical decisions made for these babies will be at the discretion of     the attending neonatologist/infant care team according to standard practice at each     institution. Data on blood pressure management in the first 24 postnatal hours collected for     each infant.   "
230771|NCT00874406|"     The purpose of this study is to investigate whether preoperative TAC is able to improve     progression free survival and overall survival in patients receiving liver metastasis     resection of colorectal cancer.   "
230772|NCT00874419|"     Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) such as erlotinib     have proved effective in second or third line therapy for advanced non-small cell lung     cancer(NSCLC).It is well tolerated without the side effects usually associated with     chemotherapy. The mutations in EGFR exons 19 or 21 have been reported to be associated with     efficacy of EGFR TKIs.Based on the encouraging preliminary results from the Spanish lung     cancer group' prospective study reported that the efficacy of Tarceva as first line treatment     for metastatic NSCLC patients with EGFR mutation would delay disease progression,prolong     overall survival and be well tolerated, medium Progression-free survival(PFS) was around 12     months and OS reach 24 months，our study is designed to compare PFS between the patients with     mutant EGFR treated by gemcitabine/carboplatin and those by erlotinib in the first-line     setting. We assumed 11 months of PFS on Tarceva arm versus 6 months on chemotherapy arm with     a=0.025(alpha-spend for an interim analysis), 80% power and 12 months enrolment period, 12     months FU duration to calculate the sample size. The sample size is 69 pairs. Considering     about 10% drop-out rate, the final sample size is 152 patients.So, chemo-naive staged IIIb/IV     patients with EGFR mutations in exon 19 or 21 will be enrolled into this open-label,     randomized,multicenter phase III study.   "
230775|NCT00874458|"     RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and     find out how far the disease has spread.      PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women     with ductal carcinoma in situ.   "
230776|NCT00874471|"     Uveitis is a group of troublesome diseases that collectively represent a cause of blindness     comparable to diabetes. Most forms of uveitis are either infectious or immune-mediated. The     investigators propose to create a data base on peripheral blood gene expression for patients     with 3 of the most important diseases associated with uveitis: ankylosing spondylitis,     sarcoidosis, and Behcet's disease. The investigators will quantitatively measure the     expression of consistent alteration in peripheral blood from patients with more than 40,000     gene sequences using microarray gene chip technology. This approach is known to detect     systemic immune-mediated disease. The investigators will use this data base to:        1. Determine if patients with uveitis and ankylosing spondylitis, sarcoidosis, or Behcet's          can be distinguished from a normal population or controls with the same systemic disease          but no history of uveitis        2. Determine if the profile of gene expression can distinguish infectious or idiopathic          forms of uveitis from patients with spondylitis, sarcoidosis, or Behcet's        3. Determine how this gene profile changes over time as episodic disease such as          spondylitis or Behcet's activates or remits        4. Correlate the changes in gene expression with the prognosis of the ocular inflammatory          process.      The creation of a gene expression data base for patients with uveitis has the potential to     clarify the pathogenesis of disease, establish new diagnostic tools, and provide a means for     predicting prognosis.   "
230777|NCT00874484|"     The investigators hypothesize that injections of Low molecular weight heparin (LMWH)     [enoxaparin] will reduce pain in women with vulvodynia.   "
230778|NCT00874497|"     Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the     pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.   "
230779|NCT00874510|"     This study will consist of a randomized controlled trial in which the investigators test the     feasibility and effectiveness of mandatory nap programs for physicians in training. One site     will be the general medical service of the Philadelphia Veterans Affairs Medical Center. The     other will be the oncology service of the Hospital of the University of Pennsylvania. The     primary outcome will be the amount slept while on call. The first year will test the efficacy     of a 5 hour mandatory nap schedule, the second year will test the efficacy of a 3 hour     mandatory nap schedule.   "
230780|NCT00874523|"     To compare the steady-state pharmacokinetics and short-term efficacy and safety of two dosing     strategies of raltegravir and atazanavir in virologically suppressed HIV-infected adults     receiving atazanavir-containing combination antiretroviral therapy.   "
230781|NCT00874536|"     It is assumed that only 1/5 of children diagnosed with attention-deficit-hyperactivity     disorder (ADHD) are treated. New treatment modalities are urgently needed. Omega-3 fatty     acids have been used in this setting, yet results are conflicting. The parent omega-3 fatty     acid alpha-linolenic acid (ALA) has only been used in one trial. 40 children diagnosed with     ADHD will be randomized to consume either ALA or placebo for two months. Baseline and end     assessments will include ADHD-related questionnaires and a computerized test. The     investigators hypothesize that ALA supplementation will prove beneficial for children with     ADHD.   "
231044|NCT00876551|"     The purpose of this study is to determine the short and long term outcome of endoscopic     vacuum assisted closure of intrathoracic postsurgical leaks.   "
230784|NCT00874575|"     The purpose of the study is to        -  Test the effect of a dietary supplement beta-hydroxy-beta-methylbutyrate (HMB) with and          without Vitamin D to prevent and reverse the losses of muscular strength and          functionality in older adults.      The second aim of the study is to determine if HMB and Vitamin D improves markers of bone     turnover in adults aged 60 plus years. HMB is a dietary supplement that comes from the amino     acid leucine. HMB is found in foods and is made in your body after you eat protein (meat).     Subjects will be randomized to one of four dietary supplement groups and will participate in     a 3-day per week exercise program for 12 weeks. Each exercise day will be about 60 minutes     long consisting of strength training exercises utilizing Theraband® stretch cords and     jumping.      Subjects will consume the dietary supplement 2 times per day for 12 weeks. Tests will consist     of the following:        -  Measuring the strength of subjects' legs by using a Isokinetic Dynamometer        -  Measuring body composition        -  Measuring hand-grip strength using a hand-grip dynamometer        -  Measuring functional mobility, balance and agility by the time it takes for you to rise          from a chair, walk around a cone 8 feet in front of the chair and return to the chair          (Up-&-Go Test        -  Filling out questionnaires and having blood drawn for biochemical measurements. Testing          will be performed at the beginning and at 4, 8 and 12 weeks.   "
230785|NCT00874588|"     The purpose of this study is to evaluate the safety, tolerability, immune response and     clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, CDCA1,     VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.   "
230786|NCT00874601|"     The manipulation of blood pressure in acute cerebral ischemia has been a matter of debate     until now. The investigators are clearly in need of more detailed data on how     antihypertensive treatment affects outcome in acute phase of stroke.      This study will assess the effects of modest blood pressure (BP) lowering manipulation in     acute period of ischemic stroke on death or dependency at 90-day.   "
230787|NCT00874614|"     This clinical trial is designed to evaluate the effectiveness and collect additional safety     information on Ultratrace® Iobenguane I 131 for the treatment of relapsed/refractory (to     other treatment) malignant pheochromocytoma and paraganglioma.      The purpose of this trial is to test the use of Ultratrace® iobenguane I 131 as a treatment     for pheochromocytoma and paraganglioma type cancer. This Phase II study will help determine     primarily if using the drug reduces the amount of blood pressure medication being taken as a     result of the cancer and secondarily to determine such things as the effectiveness of the     study drug in treating the cancer, additional safety measures, and to assess if the drug     helps the quality of life and use of pain medication. All subjects will receive an imaging     dose with scans followed by two therapy doses that are given 3 months apart.   "
230806|NCT00867698|"     The purpose of this study is to determine whether AST-120 is safe and effective in the     treatment of mild hepatic encephalopathy.   "
230788|NCT00874627|"     Sublingual immunotherapy is developing in the treatment of aeroallergens allergy. The     hypothesis is that such process may be applied to food allergy, more precisely to milk. A     previous series of 8 patients indicates the likely effectiveness of this technique (Allergy,     2006).   "
230789|NCT00874640|"     To evaluate patient characteristics in the current daily radiological practice of Gadovist     application. Special focus will be laid on the individual risk factors of patients, the     indications for and the dose of Gadovist application.      Secondary objective is to prove the known safety profile (especially rare adverse events) of     Gadovist and to collect data on handling problems with different application forms (one     questionnaire per center).   "
230790|NCT00874653|"     The purposes of this study are:        -  To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual          bleeding treatment by Mirena.        -  To collect italian data for Mirena in clinical routine.   "
230791|NCT00874666|"     This study will measure the bioavailability of allicin, the main active compound of garlic,     from garlic supplements and garlic foods (raw, cooked, processed) so that        -  supplement manufacturers and clinical investigators know how supplements need to be made          and consumed to obtain high bioavailability        -  consumers can know how garlic can be prepared to obtain any established health benefits          of garlic.   "
230792|NCT00874679|"     The aim of this prospective, non-interventional post-marketing surveillance study is to     obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction.     Furthermore, the data collection particularly focuses on the experience of the patient and     his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients     will be included in the study.The maximum observation period per patient is 12 months.Besides     the physician's documentation, the patient should fill out a questionnaire at every visit.     The questionnaires will be handed out and collected by the physician. Furthermore, an     additional questionnaire for the patient's partner can be distributed at each visit in case     the partner is willing to participate.   "
230793|NCT00874692|"     The purpose of this study is to evaluate the impact of a passive safety measure, namely a     reduction in centrally controlled hot tap water temperatures in social housing using a boiler     management system, as an effective public health intervention.   "
230794|NCT00874718|"     The study consists of evaluating the efficacy of an Educational Program for prevention of     occupational musculoskeletal problems in workers. It is a randomized clinical trial with     parallel groups and blinded evaluator, with a control group not submitted to the educational     program, but that received a program for general orientation in health. The primary outcome     was the change of the quality of life measured by means of Medical Outcomes Study 36-Term     Short Health Survey (SF-36), that it is a generic instrument of evaluation of the quality of     life, translated and validated in Portuguese of Brazil.   "
230795|NCT00874731|"     To assess the potential for ridaforolimus to prolong the QTc interval (an effect on the     electrical activity of the heart) in participants with advanced cancer. This study will be     done in 2 parts. Part 1 will evaluate the effect of a single 100 mg dose of ridaforolimus on     QT interval in participants with advanced cancer. Fridericias's correction (QTcF) will be     used. In Part 2 participants will receive ridaforolimus at the current therapeutic dose (40     mg x 5 days).   "
230796|NCT00874744|"     The purpose of this study is to compare a single intravitreal injection of 4.0 mg of     triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular     edema.   "
230797|NCT00867581|"     The purpose of this study is to observe delayed neuronal death of hippocampus after middle     cerebral artery infarction in human beings.   "
230800|NCT00867620|"     Bladder cancer ranks the ninth in worldwide cancer incidence. Approximate 90% of bladder     cancer is the malignancy of urothelium tissues, the urothelial cancer (UC). The mortality of     bladder cancer is mainly due to recurrence and metastasis. Unfortunately, the currently     available cytology or cystoscopy examination is of limited value because of low sensitivity     of early disease. New biomarkers as well as detection technology are thus required to improve     early diagnosis. By the aid of quantitative methylation-specific PCR (QMSP), which allows     detecting tumor-derived DNA from tissues and body fluids, DNA methylation-based assay is thus     developing for early detection and prognosis.      The goal of this proposed project is to develop a panel of DNA-methylation based biomarkers     for UC diagnosis, prognosis, and prediction of responses to therapy (especially the     recurrence, invasion, survival, and responses to therapeutic agents). Although numerous     studies have investigated the aberrant promoter hypermethylation in bladder cancers or UC,     inconsistent results are observed. DNA hypermethylation determination may rely on not only     the conditions of QMSP, but also the biopsy specimens of different race, environmental expose     factors, and regional variation. We thus need to profile the DNA methylation pattern of UC     patients in Taiwan to establish a panel of potential prediction biomarkers for local     patients.   "
230801|NCT00867633|"     To study the association between aristolochic acid and urothelial carcinoma in Taiwan   "
230802|NCT00867646|"     Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine   "
230803|NCT00867659|"     This pilot study aims to address whether the prophylactic use of Cetrorelix Acetate after a     long gonadotropin-releasing hormone (GnRH) agonist protocol post-hCG (human chorionic     gonadotropin) administration can significantly reduce the incidence of OHSS in oocyte donors.   "
230804|NCT00867672|"     AML of the older patient constitutes a major unmet clinical need since the large majority     will not be found eligible for induction chemotherapy. Reasons for this decision include host     factors (comorbidities, reduced performance status, functional limitations due to age),     leading to often poor tolerance of repeated chemotherapy courses and the unfavorable biology     underlying this disease in older patients. Low dose Decitabine has shown very promising     efficacy in high-risk MDS and is therefore a very promising approach also in older AML     patients. Preliminary results from several centres have demonstrated excellent feasibility     and good efficacy of this treatment. Therefore the investigators intend to investigate the     effects of two drugs added onto low-dose Decitabine which have shown very promising     synergistic effects in vitro and for which preliminary results indicate that the combination     with low-dose Decitabine is very feasible.   "
230805|NCT00867685|"     The purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet     form of the same drug. This study will also study the effect of food on the tablet form of     the drug.   "
230809|NCT00867737|"     The objectives of this study are to measure Impulse Oscillometry (IOS) in patients with     asthma extensively at baseline in patients with mild-to-moderate asthma, treated with     as-needed short acting beta agonist only, to measure respiratory resistance and small airway     dysfunction accurately and precisely at baseline, from which to measure onset of action of     Advair MDI in comparison with that of Symbicort MDI. Initial screening will assess IOS     resistance and small airway dysfunction and its response to short acting beta agonist (SABA).     Patients will be selected from among those who manifest a 40% improvement in small airway     function assessed by IOS low frequency reactance after SABA compared to baseline. After     screening, patients will be randomized to receive either Advair or Symbicort; and will be     assessed at randomization before and at several intervals after initial dosing, up to 4     hours. Patients will return again 4 weeks after randomization for extended IOS (and     spirometry) testing as done at randomization.   "
230810|NCT00867750|"     This study is open to patients with primary HCC who cannot be treated by potentially curative     treatment modalities, such as surgical resection, liver transplantation or percutaneous     ablation.      Patients that satisfy the study eligibility criteria will be randomised in a 1: 1 ratio to     receive either Radioembolisation with SIR-Spheres Microspheres or the standardised     Transarterial Chemoembolisation procedure.      Study Objectives      This study will evaluate and compare quality of life as well as safety and efficacy of RE or     TACE in patients with unresectable HCC. Patients will be followed for a minimum of 12 months     or until death wherever possible in the evaluation of the primary and secondary objectives of     this study.   "
230811|NCT00867763|"     Methods of infertility treatment may involve in vitro fertilization or IVF. Though effective,     IVF is complex and expensive. Methods using no gonadotropin hormone stimulation of the     ovaries are being compared to mild stimulation doses. The goal of the research is to     determine which of these if more suitable as a low cost approach for varying individual     patients.   "
230812|NCT00867776|"     The purpose of this study is to pilot-test a culturally-tailored, community-based educational     program for African-Americans, focusing on how to use exercise and other self-management     strategies to reduce depressive symptoms and improve health. This study will explore what     type of additional support would encourage depressed African-Americans to exercise regularly.     The investigators hypothesize that participants will report greater frequency of exercise and     lower depression scores at the end of the program than they did at baseline. However, this     study is not adequately powered to test this hypothesis - the main goal is to assess     feasibility, acceptability and satisfaction of the pilot intervention.   "
230813|NCT00867789|"     The purpose of this study is to determine if there is a difference between an antibiotic,     trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses     following incision and drainage.   "
230814|NCT00867802|"     The purpose of this study is to assess the effect of meditation training called     Mindfulness-Based Stress Reduction on reducing the symptoms of psychological distress among     adult survivors of child abuse.   "
230817|NCT00867841|"     Pneumonia, or lung infection, is usually treated with antibiotics targeted against the     organisms that the physician guesses are causing the problem. The determination of the exact     cause of a patient's pneumonia is difficult. The problem is that the two major causes of     community-acquired pneumonia are not easily distinguished on clinical grounds and are best     treated by different antibiotics. The investigators hypothesize that antibiotic therapy can     be targeted and improved by doing polymerase chain reaction (PCR) testing of nose swabs to     identify probable implicated organisms and their antibiotic resistance patterns. This pilot     study will be important to ensure that the laboratory testing is functional and that the     emergency department-laboratory communication is optimal prior to doing a full-fledged     randomized clinical trial.   "
230818|NCT00867854|"     This laboratory-based sub-study of ATN 061 and ATN 071 will examine the effect of early     treatment followed by treatment de-intensification to atazanavir/ritonavir (ATV/r)     monotherapy on steady-state frequencies of replication-competent CD4+ T cell Human     Immunodeficiency Virus (HIV)-1 reservoirs or cell-associated infectivity (CAI) and persistent     low-level viremia (LLV), and their contribution to successful long-term control of HIV-1     replication among HIV-1 infected adolescents and young adults.   "
230819|NCT00867867|"     Iron fortification of foods is usually considered the most cost-effective approach to prevent     iron deficiency. However, iron is the most difficult mineral to add to foods. When added as     water-soluble, highly bioavailable compounds such as ferrous sulfate, the soluble iron     rapidly catalyzes fat oxidation resulting in rancid products. In addition, water-soluble iron     compounds can cause unacceptable color reactions during storage and food preparation. Thus,     food manufacturers are often obliged to use water-insoluble iron compounds to fortify foods     and fortification compounds such as elemental Fe powder and ferric pyrophosphate are widely     used to fortify cereal flours and infant cereals. However, these compounds never dissolve     completely in the gastric juice and are usually far less well absorbed than ferrous sulfate     (Hurrell 1997). Ferrous fumarate on the other hand, although almost insoluble in water,     readily dissolves in the gastric juice and has been shown to have an equivalent absorption to     ferrous sulfate in healthy, Western adults (Hurrell et al. 1989, 2000). Because it is     non-water soluble, it causes relatively few sensory problems in the fortified foods and is     therefore an interesting food fortificant. Iron absorption from ferrous fumarate has been     demonstrated to be significantly higher than from ferric pyrophosphate in European infants     (Davidsson et al. 2000) and this compound is currently used to fortify blended cereal flours     for food aid programs and commercial infant cereals in Europe. However, based on our recent     study in Bangladeshi children, there is now concern that due to lower gastric acid output,     young children in developing countries may not be able to absorb ferrous fumarate as well as     Western adults (Davidsson et al. 2001a, Sarker et al. 2001, 2003). Clearly, there is a need     to evaluate the efficacy of water insoluble iron compounds to prevent the development of iron     deficiency/iron deficiency anemia in infants and young children living in developing     countries. The aim of this study is to evaluate the efficacy of ferrous fumarate and ferric     pyrophosphate, as compared to ferrous sulfate, as food fortificants in preventing development     of anemia/IDA in Bangladeshi infants and young children (part I).      A potential cause of low gastric acid secretion in Bangladesh and many developing countries     is Helicobacter pylori infection. Although H. pylori-infection appeared to have no influence     on absorption of ferrous fumarate in children, the impact of chronic H. pylori infection in     adults could be expected to be more pronounced due to long time effects on the gastric     mucosa, resulting in reduced gastric acid output. The other aim of the study is therefore, to     assess of iron absorption and gastric acid output in adult women of child-bearing age with H.     pylori infection (part II).      Two hundred and forty non-anemic Children (Hb>105 g/L) will be randomized to three study     groups; ferrous fumarate, ferric pyrophosphate or ferrous sulfate (n=80 per group) in wheat     flour- and cow milk-based infant formula and will be fed for 9 months. Hemoglobin, serum     ferritin, and transferin receptor will be analyzed at baseline and after 4.5 and 9 months of     intervention. Prevalence of anemia and iron deficiency during and after the intervention     among the three groups will be compared (part I). We furthermore propose a complementary     study to determine the relative absorption of ferrous fumarate (relative to ferrous sulfate)     in H. pylori infected and non-infected adult Bangladeshi women (15 each) of 20-40 year of age     with IDA using stable isotope technique based on the incorporation of iron stable isotopes     into erythrocytes 14 days after administration. Assessment of gastric acid output will also     be performed. Iron stature and absorption, and assessment of gastric acid output will be     compared before and after therapy in H. pylori infected women (part II). The results of this     study are expected to have implications in the prevention and treatment of iron deficiency     anemia in developing countries   "
230820|NCT00867880|"     The primary objective of this study is to evaluate the pharmacokinetic profile of a single     dose of IVIb administered over 5-7 minutes.   "
230821|NCT00867893|"     Some medications used to treat the restless legs syndrome (RLS) when taken for some time make     the condition worse. This study seeks to find a method for early detection of this problem so     that it can either be prevented or corrected.   "
230822|NCT00867906|"     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with     allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived     peptide desensitising vaccine, currently being developed for the treatment of cat allergy.      This study will evaluate the safety and tolerability of multiple doses of Cat-PAD in     controlled asthmatics treated with either inhaled salbutamol, inhaled corticosteroids or     inhaled corticosteroids with a LABA and to explore the efficacy of Cat-PAD in these subjects     using the Late Phase Skin Response, Early Phase Skin Response, and Conjunctival Provocation     Test.   "
230823|NCT00867919|"     This study will design and test a cognitive behavioral therapy for depressed adolescents that     uses family interactions to help with treatment.   "
230824|NCT00867932|"     The purpose of this study was to determine appropriate dose regimens of eculizumab in     pediatric and/or adolescent patients with paroxysmal nocturnal hemoglobinuria (PNH).   "
230825|NCT00867945|"     The investigators hypothesize that pregnancy-induced analgesia might be the result of     enhanced descending noxious inhibitory activity.   "
230893|NCT00868842|"     This is an open-label, single-center study of whether oral penicillin desensitization of     healthy sensitive subjects results in allergen cross-desensitization of mast cells by skin     testing and desensitization of peripheral blood basophils. The primary endpoint(s) will be     PC3 prick skin test values to penicillin, aeroallergen(s) and codeine. Secondary endpoints     will be levels of Syk in purified basophils determined by flow cytometry (mean fluorescence     intensity) and basophil degranulation (% tryptase release) to anti-FcåRI and to calcium     ionophore.   "
230826|NCT00867958|"     Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication:     Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during     colonic or colorectal resection.      Study Design: Prospective, open labeled study. Patient Population: Male or female subjects 18     years of age or older who are scheduled for non emergency laparoscopic or open colonic or     colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the     discretion of the surgeon.      No. of Subjects: 15 patients estimated up to three months to enroll. Duration of Treatment:     During the operation - creation of the anastomosis. Duration of Follow-up: Follow-up     evaluation will be performed daily while hospitalized, during a post-op clinic visit at     approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3     months.      Endpoints: To evaluate the creation of a safe and functioning anastomosis and the occurrence     of adverse events related to the use of the CAR™ 27 device.   "
230827|NCT00867971|"     Recombinant growth hormone is a common therapy in the pediatric population. A number of     associated side effects have been described. Several years ago, a case report was published     concerning a child that was treated with RGH and developed acute glaucoma. To date no study     has evaluated the connection.   "
230828|NCT00867984|"     Approximately 40% of resynchronization therapy recipients do not appear to clearly benefit.     These patients are termed 'non-responders'. This study will assess whether a heart ultrasound     (echo) technique called 'torsion imaging' can be used to increase the likelihood of benefit     from resynchronization therapy.   "
230829|NCT00867997|"     The overall objective of this three-armed randomized clinical trial (RCT) is to determine the     comparative efficacy of three treatments for hypersensitive noncarious cervical lesions     (NCLs): chemoactive dentifrice use, dentin bonding agent (DBA) with sealing, and flowable     resin-based composite restoration. The primary outcomes of this study are the     reduction/elimination of hypersensitivity and the effect of treatment as measured by     patient-reported outcomes. Secondary outcomes, as determined by laboratory evaluation of     intraoral replicas of pre- and posttreatment NCL surfaces, are tubule occlusion, retention of     resin coating, retention of restoration, and change in lesion size. Outcomes will be     ascertained via the following specific aims:      Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by both     measurement and by patient-reported outcomes among three treatment groups.      Specific Aim 2: To recruit subjects with teeth with hypersensitive NCLs, measure baseline     sensitivity and subject quality of life, administer one of three different treatments to each     of three randomized groups of subjects, and determine immediate posttreatment     hypersensitivity.      Specific Aim 3: To compare the degree of tubule occlusion before and after the three     treatments and to associate these findings with posttreatment hypersensitivity,     patient-reported outcomes, and restoration retention.      Treatment of NCLs remains controversial. Few studies have compared treatment methods or their     financial implications. This RCT will determine the reduction of NCL hypersensitivity and     patient-reported outcomes over a 6-month period for each of three different treatments. This     will be the first practice-based research network RCT to combine objective clinical     assessment of NCL treatment patient-reported outcomes with laboratory examination of dentin     tubule occlusion and lesion size.   "
230830|NCT00868010|"     This is a 12-week, randomized, placebo controlled study to determine if donepezil (Aricept)     treatment during rehabilitation after stroke improves functional recovery.   "
230831|NCT00868023|"     Multinational, multicentre, randomised, double blind, double dummy, placebo and active     controlled, 5-way cross over   "
230832|NCT00868036|"     Hives affects 10-25% of the population worldwide at some time during their lifetime. Hives     are itchy transient swellings of the skin lasting 4-36 hours. Chronic urticaria is defined as     hives that have been ongoing for six weeks or more.      Patch testing is performed to diagnose allergic contact dermatitis, and if contact allergens     are found via patch testing, patients can often be cured of their dermatitis. However, patch     testing is currently not routinely performed in the evaluation of patients with chronic     idiopathic urticaria.      Our hypothesis is to see if contact allergens can be identified with patch testing in     patients with chronic urticaria, and, if any allergens are identified, to see if avoiding     these contact allergens will make the chronic urticaria go away.   "
230834|NCT00868062|"     In situations such as dehydration, illness and surgery, fluid 'drips' are given to patients     to keep them hydrated. Different fluids stay in the circulation for different lengths of     time. For example, some types of fluid remain in the circulation for a short time which means     patients would need to be given more fluid to achieve the desired effects. Giving a lot of     fluid to sick patients can in itself cause problems, for example, it can affect the way the     bowels work and delay the patient's recovery from illness. In these situations the     investigators use specialized fluids called colloids, that are designed to stay in the     circulation for longer. This means a smaller amount of fluid needs to be used and less     problems are likely to occur. There are two different types of colloids that are commonly     used, but the investigators do not know which of them is better. The purpose of this study is     to investigate which of the two different colloids (one is called Gelofusin and the other is     called Voluven) works better in patients who undergo surgery. Knowing which of the two fluids     works best in patients will help us improve the care of surgical patients. The investigators     hypothesis is that the fluid that has the larger size of molecules as part of the solution     will work better during surgery.   "
230835|NCT00868075|"     The aim of our study is to ascertain whether chest physiotherapy + pulmonary rehabilitation     is more efficacious than chest physiotherapy alone. The outcomes that will be used to assess     effectiveness are relevant in terms of the direct benefit on the patient's health related     quality of life.      PLANNED STUDY: This randomized study will compare 8 weeks chest physiotherapy with 8 weeks     chest physiotherapy plus pulmonary rehabilitation.   "
230836|NCT00868088|"     Our study is designed to evaluate the efficacy of photodynamic therapy (PDT) for treatment of     actinic cheilitis (AC) and as an adjunct to Mohs surgery for squamous cell carcinoma (SCC) on     the lips. This study will utilize an FDA approved PDT modality (DUSA, Inc., Wilmington, MA     01887) using topical 5-amino-levulinic acid (ALA) for photosensitization followed by exposure     to a Blu-U light source emitting 405-420nm wavelength light.   "
230837|NCT00868101|"     The study research is to analyse brief episodes of limb ischemia applied to children the day     before open heart surgery as protection from myocardial injury induced by extracorporeal     circulation.   "
230838|NCT00868114|"     This research study uses radiation or a gene therapy agent, TNFerade in addition to a     dendritic cell vaccine in patients with locally advanced or low volume metastatic pancreatic     cancer. The use of TNFerade or radiation serves to generate cell death stimulating the immune     response. The dendritic cell vaccine may direct a distant and lasting effective anti-tumor     immune response to achieve a local and systemic clinical benefit.   "
230839|NCT00868127|"     The purpose of this study is to determine the long-term safety of lapaquistat acetate, once     daily (QD), as monotherapy or in combination with other lipid-lowering agents in Subjects     with Hypercholesterolemia.   "
230840|NCT00868140|"     Our hypothesis is that hyperinsulinemia increases the renal clearance of D-chiro-inositol     (DCI) in women with polycystic ovary syndrome (PCOS) and that this leads to a reduction in     circulating insulin-stimulated D-chiro-inositol-containing inositol phosphoglycan (DCI-IPG)     release. To assess the effects of a chronic reduction in circulating insulin on DCI     metabolism, we propose to reduce circulating insulin in obese women with PCOS by improving     insulin sensitivity with the drug pioglitazone. Pioglitazone is a thiazolidinedione that     improves peripheral insulin sensitivity, presumably by activation of the peroxisome     proliferator-activated receptor gamma (PPARγ) receptor. Administration of pioglitazone to     women with PCOS has been shown to improve insulin sensitivity, reduce insulin secretion, and     decrease both fasting and post-prandial serum insulin concentrations.   "
230841|NCT00868153|"     This is an open-label, uncontrolled, multi-centre observational study that analyses a     follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a     period of one year.The patients evaluated at four visits, beginning with the insertion visit     and 3, 6 and 12 months after insertion.   "
230842|NCT00868166|"     The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as     add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as     compared to placebo, assessed by the 18-month survival rate.   "
230843|NCT00868179|"     Currently standard of care for preventing blood clots in total knee replacement patients is     the drug Fragmin which is a daily injection for 10 days after surgery. Patients are in     hospital for 3 to 5 days after total knee replacement surgery and patients are taught in     hospital to do their injections.      The investigators would like to introduce the drug Pradax. Pradax is a Health Canada approved     once a day, oral drug that may prevent blood clots in the patient's leg. In this study the     patient will receive the standard of care injection drug Fragmin while in hospital but on     discharge home the patient will take the oral drug Pradax daily (2 tablets 110mg) for 10     days.   "
230844|NCT00868192|"     The purpose of this study is to determine if the combination of bevacizumab and pemetrexed     have an effect on recurrent ovarian and primary peritoneal carcinoma by looking at     progression and survival at 6 months.   "
230845|NCT00868205|"     Food and beverage intake that leads to a decrease in the level of in vivo markers of     oxidative stress indicates that such foods and beverages act as antioxidants (AOX) in humans.     Coffee drinking at a high level (> 900 ml/day) for a short period of time (1 week) has been     shown to reduce DNA oxidative damage—as indicated by a decrease in the level of percent tail     DNA (%T)— in study populations comprised mainly of young adults aged < 30 years. It is not     clear whether such findings remain present over a longer period of time, and to extend such     findings across a population that is more representative of European adults who consume     common daily intakes of coffee, which is a low-to-moderate daily intake level (< 750 ml/day).     As such, the investigators propose to determine the effect of drinking 3 and 5 cups of coffee     per day (equivalent to 450 and 750 ml per day, respectively) for 8-weeks on markers of in     vivo oxidative stress relative to control in a population of healthy adults free of chronic     diseases aged 35 to 65 years. To ensure that overall health is considered, the investigators     will also evaluate the effect on markers of cardiovascular health, inflammation, and glycemic     control.   "
230875|NCT00868608|"     The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in     subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after     multiple therapies including rituximab or radioimmunotherapy. The investigational drug will     be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every     4 weeks.   "
230846|NCT00868218|"     The safety and tolerability of the pandemic A/H5N1 virosomal vaccine formulated with or     without the 3rd generation ISCOM™ adjuvant for parenteral administration will be investigated     locally and systemically and by using haematological, biochemical and immunological screening     tests. The immunogenicity of the H5N1 vaccine will be assessed through the induction of local     and systemic antibody and cellular immune responses. In a pandemic situation, an important     aspect is the rapidity of the immune response to the H5N1 vaccine so the detailed kinetics of     the immune response will be investigated. The capacity of the vaccine to elicit long lasting     immunity and cross reactive immunity to H5 viruses will also be evaluated. Furthermore, the     quality of the immune response induced by the vaccine will be studied. The vaccine will be     administered as twice the normal human dose (30μg HA) with and without adjuvant, and in a     dose sparing manor of half (7.5μg HA) and one tenth (1.5μg HA) of the normal human dose with     adjuvant. Sixty subjects will receive two doses of virosomal H5N1 influenza vaccine     (separated by 21 ± 4 days) by intramuscular injection into the deltoid muscle. Escalating     doses will be separated by a period of one week. Four groups each containing 15 subjects will     receive two doses of the pandemic virosomal A/H5N1 influenza vaccine containing:      Group 1 30µg HA IM, Group 2 1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 3     7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 4 30µg HA adjuvanted with 50µg     3rd generation ISCOM™ IM.   "
230847|NCT00868231|"     The main purpose of this study is to evaluate the efficacy, safety and tolerability of     multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.   "
230848|NCT00868244|"     The purpose of this study is to determine if the facial pattern is related to the degree of     bruxism because the muscles of mastication are the factors of force to the wear of the teeth.   "
230849|NCT00868257|"     This study will compare methods of determining whether HIV-infected children take their     medications.   "
230850|NCT00868270|"     The prevalence of kidney scarring after UTI is approximately 5-57%. UTIs are caused mainly by     bacteria that cause local and systemic immunological reaction that are accompanied by     cytokines. These cytokines are a main factor in the inflammatory process. They are produced     by leukocytes, macrophages, fibroblasts, endothelial cells and epithelial cells in the kidney     tissue. Interleukin 6 and 8 (IL-6 IL-8) were found in high levels in the urine of children     and adults who suffer from UTIs. Other studies on animals have found a relationship between     inflammatory reaction and scarring in the kidney. We hypothesize that we will find a similar     relationship between the level of IL-6, IL-8 in the urine during acute pyelonephritis in     children and the probability of kidney scarring.   "
230904|NCT00868985|"     The study is to evaluate the influence of three different doses of PEG 3350 with or without     electrolytes on the electrolyte balance in patient volunteers with confirmed chronic     constipation.   "
230851|NCT00868283|"     The study investigated the clinical efficacy and safety of a 10-day course of therapy with     daily intravenous administration of 30mL Cerebrolysin based on a comparison with Placebo in     patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2     parallel groups, one receiving Cerebrolysin, the control group receiving Placebo. Study drug     will be given once daily by intravenous infusion for 10 consecutive days. Acetylsalicylic     acid will be given orally, once daily throughout the study duration of 90 days as basic     treatment. The clinical observation period for each patient will be 3 months and will include     six clinical evaluation visits at Baseline (day 1) and on study days 2, 5, 10, 30 and 90.   "
230852|NCT00868296|"     The purpose of this study is to provide additional information on safety and tolerability     after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331     study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this     study.   "
230853|NCT00868309|"     This phase II study was a prospective, randomized, open-label, multi-center study in the     United States, involving patients from 18 to 70 years of age, comparing Anavip (Antivenin     Crotalinae [pit viper] equine immune F(ab)2; Instituto Bioclon, Mexico City, Mexico) against     CroFab (Protherics Inc., Nashville, Tennessee), the only currently approved product for     treatment of Crotalinae (pit viper) envenomation in the US.      The study was designed to evaluate the hypothesis that lasting correction of snakebite     induced thrombocytopenia and hypofibrinogenemia are possible following correction with F(ab)2     antivenom, by analyzing in detail the relationships among platelet count, fibrinogen, venom     levels, and antivenom levels in subjects presenting with thrombocytopenia following crotaline     viper envenomation. In the study we expected to see a fall in platelet count following Fab     treatment, commensurate with that reported in the past. We hypothesized that following F(ab)2     treatment there would be a slower drop in post-treatment platelet counts, with a relatively     higher platelet count at any given point in the follow-up period. We further hypothesized     that an initial rise and later fall in platelet count would correspond with rise and fall in     antivenom levels, and would be mirrored by concurrent drop and rise in levels of unbound     circulating venom.   "
230854|NCT00868335|"     The purpose of this study is to find out if use of a cervical disc prosthesis in the     treatment of a cervical disc herniation preserves or restores normal mobility and movement in     the cervical spine.   "
230855|NCT00868348|"     The purpose of this study is to determine wether ketorolac is effective in the treatment of     postoperative pain after total knee arthroplasty   "
230856|NCT00868361|"     The purpose of this study is to characterize the chemical breakdown and excretion of     talampanel and its break down products in plasma, feces, and urine of healthy human     volunteers.   "
230857|NCT00868374|"     The primary objective is to test the hypothesis that quetiapine XR (Extended Release)     monotherapy or adjunctive therapy to antidepressant is superior to placebo monotherapy or     placebo adjunctive therapy to antidepressant(s) in the acute treatment of depression symptoms     in patients with MDD and comorbid GAD. The secondary objectives are to test the hypotheses     that quetiapine XR is superior to placebo in the reduction of anxiety symptoms in patients     with major depressive disorder and comorbid generalized anxiety disorder, the improvement of     the quality of sleep in patients with major depressive disorder and comorbid generalized     anxiety disorder and the improvement of the quality of life in patients with major depressive     disorder and comorbid generalized anxiety disorder.   "
230890|NCT00868803|"     The goal of the study is to gain a better understanding of the molecular changes responsible     for causing prostate cancer and that examination of tissue and blood samples will help in the     development of improved screening and therapeutic approaches.   "
230858|NCT00868387|"     The burden of overweight and obesity has dramatically increased during the last decades. High     carbohydrate intake, particularly refined carbohydrates, probably increase the risk of     obesity, type 2 diabetes, and metabolic syndrome. There is evidence that energy-restricted     low-carbohydrate diets show greater weight loss and better improvement of cardiovascular risk     markers compared to energy-restricted low-fat diets. Beside macronutrient relations, efficacy     of weight loss programs depends on care and control. The investigators aim to investigate     whether or not a carbohydrate-restricted telemedically guided weight loss program results in     a more pronounced weight loss and influences metabolic risk markers more beneficial than a     fat-restricted diet.   "
230859|NCT00868400|"     The aim of this study is to provide conclusive clinical evidence as to whether or not the     preoperative administration of oral carbohydrate-rich solutions is effective on the outcomes     of patients undergoing colorectal surgery.   "
230860|NCT00868413|"     This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with     either FCR or BR in subjects with relapsed or refractory chronic lymphocytic leukemia.   "
230861|NCT00868426|"     The aim of this pilot study is to assess the methodology, practical arrangements and     pulmonary absorption with charcoal blockage for the future bioequivalence studies. In     addition, PK of budesonide and formoterol after administration from 2 different batches of     Symbicort TH is compared with each other.   "
230862|NCT00868439|"     The purpose of this study was to assess the effects of patiromer on serum potassium     participants with heart failure. This study also assessed the safety and tolerability of     patiromer in participants with heart failure.   "
230863|NCT00868452|"     This clinical study is designed to test the hypothesis that lurasidone is effective,     tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of     patients with bipolar I depression.   "
230905|NCT00868998|"     This is a study for patients with advanced cancer of the biliary tree, such as     cholangiocarcinoma. They will be treated with a chemotherapy regimen consisting of     Gemcitabine, Taxotere, and Xeloda every 21 days for at least 9 weeks. Treatment will continue     until their cancer progresses. This chemotherapy regimen has been used in pancreatic cancer     and there is reason to believe that it will be effective for cancers of the biliary tree as     well.   "
230906|NCT00869011|"     In this randomized, controlled trial the investigators evaluate the effects of an exercise     program lasting for 12 weeks on the physical performance, the cardiovascular function (24h     blood pressure, rest blood pressure and hear function) and the fatigue and mood of patients     with renal cell carcinoma undergoing a therapy with Sunitinib.   "
230864|NCT00868465|"     Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the     first line treatment policy in Tanzania. AL is an efficacious drug that also has the capacity     to reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the     development of parasite resistance against AL and there have been very few clinical trials     that compared different ACT regimens. A recent clinical trial shows that the combination of     dihydroartemisinin-piperaquine (DP) may be more efficacious than AL and may have a more     pronounced beneficial effect on post-treatment malaria transmission. Screening for molecular     markers that are related to parasite susceptibility to ACT drugs and to post-ACT treatment     malaria transmission can assist in preventing the development and spread of ACT resistance.      In the current study, the investigators compared AL and DP for the treatment of uncomplicated     malaria. The investigators endpoints are        -  clinical efficacy        -  post-treatment gametocytaemia by molecular techniques        -  post-treatment malaria transmission.   "
230865|NCT00868478|"     The purpose of this study is to determine whether Milatuzumab is effective in patients with     refractory chronic lymphocytic leukemia, and also to find out in which range of doses is a     response seen.   "
230866|NCT00868491|"     The purpose of this study is to determine the efficacy and toxicity of     docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant     chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell     carcinoma of the head and neck.   "
230867|NCT00868504|"     Previous studies have indicated that tumors are warmer than the surrounding tissues. We want     to ascertain that this is true for tumors in the GI tract. If so, a thermal camera in an     endoscope may aid the diagnosis of tumors. The experiment entails inserting a cannula     sheathed thermocouple into the work canal of an endoscope or a colonoscope. The examining     physician will bring the distal end to touch the tumors he finds and their adjacent tissues,     noting their respective temperatures. This experiment must be conducted before embarking on     the complicated and costly project of producing a tiny thermal camera which will be able to     navigate the GI tract.   "
230868|NCT00868517|"     The purpose of this study was to examine if group ear acupuncture improves Post-Traumatic     Stress Disorder sleep difficulties among veterans who participated in Operations Enduring     Freedom and Iraqi Freedom. This study also examined the degree of veteran acceptance for a     group ear acupuncture procedure.   "
230869|NCT00868530|"     This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in     Chinese hemophilia A subjects.   "
230870|NCT00868543|"     The goal of this study is to compare the clinical efficacy (weight loss and metabolic     changes) of long (150 cm) versus very long (250cm) Roux alimentary limb gastric bypass in     superobese (BMI>50) patients.   "
230871|NCT00868556|"     This is a 2 visit research study for patients with or without a diagnosis of migraine.     Participants will be administered informed consent, have a medical history taken and a     physical examination performed, and complete 3 questionnaires at the first visit. The     participants will have a functional MRI performed after completion of Visit 1. Study stipends     will be given for each completed research visit.      The purpose of this study is to potentially identify risk factors and/or biomarkers (which     are differences in the brain structures)by comparing the brain MRI scans of migraine     sufferers to brain scans of control persons to attempt to identify migraine progression using     the functional MRI scans.   "
230872|NCT00868569|"     The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are     able to improve resection rate and overall survival in patients receiving primary colorectal     tumor resection than given FOLFOX4 only.   "
230873|NCT00868582|"     The Centers for Medicare & Medicaid Services (CMS), as the Federal agency that administers     the Medicare program, only pays for positron emission tomography (PET) scans in patients with     cancer for certain reasons and for certain types of cancer. This study was developed to help     CMS determine if they should pay for PET scans for additional reasons and additional types of     cancer. In order to collect the information needed to decide which other types of cancer     should be covered by Medicare, CMS will provide payment for the otherwise non-covered PET     scans of patients who are properly registered with the National Oncologic PET Registry     (NOPR). This information will then be analyzed to determine the effect PET scans had on the     way physicians planned to treat their patients.   "
230891|NCT00868816|"     The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles     or 12 cycles) is better for patients receiving curative colorectal cancer resection.   "
230876|NCT00868621|"     Overactive bladder (OAB) is a widespread condition characterized by urgency, urge     incontinence, nocturia and excessive urinary frequency, affecting millions of people     worldwide.(1) In two epidemiological studies, OAB was found in about 17% of American and     European populations.(2)(3). This accounts for an estimated 33 million patients suffering     from OAB in the USA. The disorder constitutes a psychological stress that impacts the     patient's social life.   "
230877|NCT00868634|"     The aim of the trial is to detect the superiority of the triple combination of capecitabine,     bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in     patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are     treated until progression of disease to determine PFS.   "
230907|NCT00869024|"     The purpose of this study is to determine if the delivery of cells just after implantation of     left ventricular assist device will help to improve the pumping function of your heart and     minimize heart enlargement in the future.      The cells will be obtained by aspiration or withdrawal of fluid from your bone marrow from     your pelvic bone using a needle and syringe. This would not take place until 24-48 hours     prior to your planned left ventricular assist device implantation. During the surgery the     surgeons will inject the prepared cells that were taken from your bone marrow and inject it     into your heart muscle.      This study will test whether receiving your own bone marrow cells directly into your heart     will help your heart to recover function after placement of a left ventricular assist device.   "
230929|NCT00869310|"     The aim of the study is to compare efficacy and tolerability of aprepitant plus dexamethasone     versus metoclopramide plus dexamethasone in the prevention of cisplatin-induced delayed     emesis in patients that received aprepitant, palonosetron and dexamethasone before     chemotherapy administration for the prevention of acute emesis.   "
230878|NCT00868647|"     This is a single-center, Phase II study including only patients on whom a decision to conduct     radiofrequency ablation (RFA) has already been made. The primary objective of this study     assess if quality of life was improved by RFA as assessed at baseline, 3 and potentially 6     and 12 months following RFA for the benign lesions.      RFA is an imaging guided percutaneous or intra-operative procedure that uses a probe on the     end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by     heating the probe (using an electrical current alternating at radio frequency) which raises     the temperature of the tumor potentially causing irreversible cell death.      RF ablation is an alternative for local tumor control when other treatments (surgery,     radiotherapy or chemotherapy) are not feasible (less effective or at higher risk). Thermal     ablation at times is the only remaining alternative for patient cure, prolonged survival or     palliation. Cryotherapy, and microwave, laser and focused ultrasound are alternative thermal     ablation techniques used in adults but there has been no experience in children with these     alternative methods.      To be eligible for this study, patients must have acquired lesions at < 21 years of age     (central nervous system lesions are excluded from this study). Study participants will have     the RFA procedure performed at Seattle Children's and will have follow-up evaluations at     various time points post-RFA.   "
230879|NCT00868660|"     Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose   "
230880|NCT00868673|"     The purpose of this study is to determine if a low fructose intake could have an impact on     weight loss, uric acid levels and the components of the metabolic syndrome (glucose,     cholesterol, triglycerides, insulin resistance, high blood pressure).   "
230881|NCT00868686|"     In most cases of acute mallet finger, or avulsion of the extensor digitorum communis terminal     tendon from the distal phalanx, splinting is the treatment strategy employed. The type of     splint used to treat these injuries continues to be controversial. Custom splints have     recently been advocated though no strong comparative evidence is available.      The primary objective of this investigation was to show superiority of the custom     thermoplastic splint over both the dorsal and volar non-custom splints. The null hypothesis     was that a radiographic lag difference greater than 5 degrees would not be observed between     groups. The primary outcome measure is the residual extensor lag difference (compared to the     contralateral equivalent digit) at 12 weeks post-splinting.   "
230882|NCT00868699|"     This clinical study is designed to test the hypothesis that lurasidone is effective,     tolerable, and safe for the treatment of patients with bipolar I depression   "
230883|NCT00868712|"     The purpose of the study is to assess whether the use of warfarin, a commonly used     anticoagulation drug, is associated with increased amounts of coronary artery calcification.     Studies in animals and preliminary but small retrospective studies in humans have suggested a     possible link to increased tissue calcification with use of this drug. The researchers will     investigate this by assessing the amount of calcification seen in the coronary arteries using     a specialized computed tomography (CT) scan (electron-beam CT) and assessing to see if the     amount is influenced by the amount of time a patient has been taking warfarin. The     researchers will exclude patients with known coronary artery disease, chronic kidney disease     or hyperparathyroidism.   "
230884|NCT00868725|"     Previous studies indicate that there are significant differences in the temperature of tumors     and normal, adjacent tissues. The present study will test this hypothesis for lesions in the     oral cavity. Thermal images of the oral cavities of patients, undergoing examination in the     Department of Oral and Maxillofacial Surgery of Sheba hospital, will be compared to the     diagnoses of the examining doctors. The results, apart from enhancing the delineation of oral     cavity tumors, may help the decision to develop miniature thermal cameras to scan thermally,     the GI tract.   "
230885|NCT00868738|"     The goal of our research is to provide data to enhance the development of nutritional     guidelines, especially as related to mineral nutrition, in children. Using human     experimentation, we are studying methods of delivering the key minerals of calcium, zinc and     iron in the diet so as to optimize health outcomes. We will conduct a controlled trial of     vitamin D supplementation to assess the effects of vitamin D status on calcium absorption in     small children. We will evaluate the effects of differing intakes of zinc on zinc and copper     absorption. These studies will utilize stable isotope techniques so as to provide accurate,     practically applicable information which may be obtained from the study populations in a safe     manner. These data will have global application and provide a strong basis for evidence-based     nutritional recommendations to be developed.      Objective #1: To evaluate the effects of supplemental vitamin D in enhancing calcium     absorption in healthy children 4 to 8 yrs of age.      Objective #2: Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of     age.   "
230886|NCT00868751|"     The purpose of this study is to see if tocilizumab is safe and effective for treating     systemic onset Juvenile Idiopathic Arthritis (soJIA). Another purpose is to see if     tocilizumab helps reduce the amount of steroids (prednisone) needed to control symptoms of     soJIA.   "
230887|NCT00868764|"     This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of     Sancuso®.   "
230888|NCT00868777|"     The hypothesis of this study is that there is a significant difference in bone maturation     after sinus grafting determined by the distance from the buccal to the palatal wall of this     cavity.   "
230889|NCT00868790|"     This study assessed the safety and efficacy of MK-3577. The primary efficacy hypothesis was     that, after 4 weeks of treatment, either the morning (AM) administration or the evening (PM)     administration of MK-3577 provides superior reduction of 24-hour weighted mean glucose (WMG)     levels compared to placebo (PLA). The primary safety hypothesis was that MK-3577 is well     tolerated compared to placebo.   "
230892|NCT00868829|"     The experimental design is a multi-center, prospective, non-controlled, non-randomized,     single-arm clinical registry trial. The study will enroll 5,000 patients who receive the     Firebird2TM Cobalt-ChromiumAlloyed Sirolimus-Eluting Stent implantation. For patient with     multivessel disease, only Firebird 2TM Stent will be implanted. The enrollment of patients     will take about 4 months. Clinical follow-up will be at 30 day, 6 month, 12 month, 24 month     and 36 month. Patients withdrawing the study due to any reasons will not be replaced.   "
230926|NCT00869271|"     The purpose of this study is to investigate whether TAC plus FOLFOX4 are able to improve     resection rate and overall survival in patients receiving primary colorectal tumor resection     than given FOLFOX4 only.   "
230894|NCT00868855|"     Coronary artery disease is the leading cause of death in USA. Contemporary cardiac care has     substantially reduced mortality and morbidity in patients with severe coronary artery     disease. However, patients with mild to moderate coronary artery stenosis (<70% stenosis)     often present in the future with life threatening acute coronary syndrome which carries     significant mortality and morbidity. It is difficult to predict outcomes in these patients     before the events because the lack of complete understanding of the mechanisms underlying     acute coronary syndrome and the lack of reliable markers that will predict major adverse     cardiac events (MACE). Tissue-type plasminogen activator (t-PA) is released from endothelial     cells and a major factor that prevent thrombosis in the coronary artery, the cause of acute     coronary syndrome. Endothelial dysfunction impairs t-PA release. Therefore, we hypothesize     that patients with impaired coronary artery t-PA release will have significantly higher risk     for future MACE due to intrinsic fibrinolytic dysfunction that leads to increased thrombosis     risk.      To test this hypothesis, we will determine whether intrinsic endothelial fibrinolytic     dysfunction predicts MACE in patients with non-significant CAD. The study will measure t-PA     release mediated by bradykinin, a major mediator for t-PA release. This will involve infusion     of bradykinin into left main coronary artery of individuals who have undergone routine     cardiac catheterization (clinically indicated). We will take blood samples from the coronary     sinus and measure t-PA and plasminogen activator inhibitor-1 antigen and activity levels.   "
230895|NCT00868868|"     A randomized clinical trial evaluating the use of a pedometer and brief exercise coaching in     prostate cancer patients treated with androgen deprivation therapy. The investigators want to     demonstrate if there are less side effects of hormonal therapy and better quality of life in     patients who made regular exercise.   "
230896|NCT00868881|"     Non-interventional,observational and retrospective study assessing the therapeutic and     diagnostic attitude followed in primary care for a hypertensive patient depending on his     degree of blood pressure control.   "
230897|NCT00868894|"     To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering     intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma     or ocular hypertension.   "
230898|NCT00868907|"     Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to     17-day washout period between doses. The study will consist of a screening visit, study     center admission (preceding Treatment Periods 1, 2 and 3), 3 treatment periods (4 days each),     1 washout period (14 to 17 days separating periods 1, 2 and 3), and exit procedures.   "
230899|NCT00868920|"     The purpose of this study is to see whether patients controlling their own sedation during     colonoscopy are less likely to need help breathing than when an anesthesiologist controls the     medicine, and whether we can predict when the need for help will occur. The pump used in the     study is approved for clinical use by the FDA, as are the medicines used in the pump.   "
230900|NCT00868933|"     Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in affluent     countries. It may progress to cirrhosis and liver cancer. At present, there is no approved     drug for NAFLD. Although healthy diet and exercise is often recommended, there is little     supportive evidence. Therefore, the investigators plan to conduct a randomized controlled     trial comparing a low glycemic index dietary intervention program and simple lifestyle advice     in NAFLD patients. The primary endpoint is resolution of NAFLD. Non-invasive tests will be     used to assess the study subjects. Proton-magnetic resonance spectroscopy is used to quantify     hepatic triglyceride content, and transient elastography is used to quantify liver fibrosis.   "
230901|NCT00868946|"     This is a treatment protocol using IND Ribavirin-there is no control group. Hemorrhagic Fever     with Renal Syndrome (HFRS) is caused by a virus acquired by contact with chronically infected     rodent hosts. HFRS is present throughout Europe and caused mainly by Puumala and Dobrava     viruses. Treatment consists mainly of supportive care with careful attention to control of     blood pressure and fluid balance and/or dialysis. Early initiation of IND Intravenous     Ribavirin has been shown to be an effective treatment for HFRS and may prevent the need for     dialysis. It is important to initiate therapy based on a diagnosis consistent with HFRS     (determination if the disease is caused by Puumala or Dobrava virus is helpful) and a history     that makes exposure likely. This study will monitor the clinical events that occur with HFRS     as well as the safety and efficacy of Ribavirin.   "
230902|NCT00868959|"     This clinical study is designed to test the hypothesis that lurasidone is effective,     tolerable, and safe for the treatment of patients with bipolar I depression   "
230917|NCT00869154|"     The aim of the study is to compare a multidisciplinary examination and follow up by     rehabilitation program with a multidisciplinary examination, good advice and follow up by the     family doctor.      Further on we will examine if there were differing clinical characteristics between patients     who attended a planned follow-up session and those that failed to and Prognostic factors in     mild traumatic brain injury patients after discharge from hospital.   "
230918|NCT00869167|"     This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on     patients with insomnia comorbid with asthma.   "
230919|NCT00869180|"     The primary purpose of this study is to assess the effectiveness of once daily application of     a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle     sprains when applied to the painful area.   "
230903|NCT00868972|"     Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal     function, refractory hypertension and flushing edema, responsible for mortality and     morbidity, especially in the elderly. Current treatment includes restoration of the renal     arterial lumen by endovascular stent placement and/or intensive medical therapy. There is no     unanimous consent on which patients could benefice of the endovascular procedure due to the     high rate of renal adverse events especially linked to atheroembolic disease. Recently, renal     revascularization using a device which consents distal embolic protection of the kidney     demonstrated to be a safe auxiliary procedure in a few non randomized studies.     Interestingly atheromatous debris was detected in 60 to 80% of these devices analyzed after     the procedure suggesting that these devices could prevent atheroembolism in a substantial     proportion of patients. On the other hand, only a randomized controlled study can prove that     renal stent with distal embolic protection is superior to renal stent alone in preserving     kidney function.      Therefore, the present study aims to compare the effects of renal artery stent placement with     or without distal embolic protection on renal function in ARAS patients.      Method:      Patients with an ARAS of ≥70% and hypertension not responsive to at least 2 antihypertensive     medications and/or renal failure (estimated GFR <60 mL/min/1.73 m2 are randomly assigned to     stent placement alone or stent placement with distal embolic protection (FILTER WIRE EX;     Cordis Endovascular, USA).      Other medications consist of statins, anti-hypertensive drugs and antiplatelet therapy.     Patients are followed for 3 months. The primary outcome of this study is a statistical     significant difference in kidney function measured as Cr clearance and cystatin C level in     the 2 groups at three months. The trial will include 150 patients.   "
230908|NCT00869037|"     The recovery from knee replacement surgery often involves a significant amount of pain. The     best way to prevent/treat this pain is unknown. This study will compare two accepted methods     of pain control in order to determine which is superior. The first method involves the     injection of a solution containing multiple medications into the knee joint at the time of     surgery. The second method involves the placement of a catheter adjacent to the femoral nerve     which senses pain from the knee. This catheter is used to deliver local anesthetic which     serves to block the transmission of pain signals from the nerve. The catheter will be left in     place until 2 days after surgery. This method is combined with injection of local anesthetic     in a particular area of the knee joint at the time of surgery. Patients will be followed     until 2 days after surgery in order to determine which method is superior. We believe the     second method will be deemed superior.   "
230909|NCT00869050|"     This phase II study is designed to assess whether treatment with capecitabine/temozolomide     (CAP/TEM) is safe and effective in treating subjects with progressive, differentiated,     metastatic neuroendocrine tumors (NET). The primary objective of the study is to determine     the radiologic response rate to this regimen in progressive, metastatic, differentiated     neuroendocrine cancers.   "
230910|NCT00869063|"     The purpose of the study is to assess the effectiveness of once daily application of a     diclofenac sodium topical patch in reducing acute pain due to mild to moderate wrist sprain,     strain or contusion when applied to the painful area.   "
230911|NCT00869076|"     The hypothesis is that patients with poorly controlled diabetes would have greater     improvement in their blood sugar control when managed by a clinical pharmacist than when     managed with usual medical care. Patients with poor control are randomized to pharmacist     management or to usual medical care for one year.   "
230912|NCT00869089|"     This trial will include:        -  Study period up to 7 months.        -  Office visits monthly lasting approximately 1 hour.        -  Blood Draws.        -  Oral medication that is taken 2 times daily.        -  Photographs and biopsies if agreed.   "
230913|NCT00869102|"     The purpose of this study is to characterise beta cell function in subjects who despite     taking part in a diabetes prevention program (life style intervention with diet and exercise)     exhibit impaired glucose tolerance and beta cell dysfunction.   "
230914|NCT00869115|"     This study explores a potential drug-drug interaction between istaroxime and digoxin in     patients with stable CHF on chronic oral digoxin treatment.   "
230915|NCT00869128|"     Objective - Type 2 uncontrolled diabetic patients often have low endogenous melatonin and     suffer from sleep disorders. The effect of a prolonged-release melatonin (PRM) formulation on     glucose lipid metabolism and sleep is studied in type 2 diabetes patients with insomnia.   "
230916|NCT00869141|"     The purpose of this study is to compare the occurrence rate of the high pressure phase and     the final pressure outcomes between patients treated with glaucoma medication prior to the     expected onset of the high pressure phase to those patients who have glaucoma medication     started at the onset of the high pressure phase. The investigators hypothesize that if     glaucoma medications are started prior to the expected onset of high pressure phase, the high     pressure phase will not occur as frequently and the ultimate pressure level will be lower     than if the glaucoma medications are started at the onset of this phase.   "
230920|NCT00869193|"     The purpose of this study is to determine whether an 8-week intervention with grape seed     extract is effective in reducing daytime ambulatory blood pressure in male and postmenopausal     female with elevated daytime blood pressure values.   "
230921|NCT00869206|"     This randomized phase III trial studies two different schedules of zoledronic acid to compare     how well they work in reducing bone-related complications in patients with breast cancer,     prostate cancer, or multiple myeloma that has spread to other places in the body and have     bone involvement. Bone-related complications are a major cause of morbidity in patients with     metastatic prostate cancer, breast cancer, and multiple myeloma. Zoledronic acid may stop the     growth of cancer cells in the bone and may help relieve some of the symptoms caused by bone     metastases. It is not yet known whether giving zoledronic acid more or less frequently is     more effective in treating patients with metastatic cancer that has spread to the bone.   "
230922|NCT00869219|"     Different case reports are showing that depending on the drug used for eye drops, it might     provoke a painful sensation. Actually two leading NSAIDs are used in ophthalmology. This     study is intended to provide information about this parameter concerning these two drugs.   "
230923|NCT00869232|"     There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma     at the MIRT from 1989 to present. Results have shown that participants treated on these     studies had better outcomes (meaning they have lived longer and had better responses to     treatment) when compared to individuals treated with standard chemotherapy.      Past studies conducted at the MIRT and at other institutions have shown that participants     with high-risk features by gene array studies tend to have shorter remissions (disappearance     of signs and symptoms of myeloma) and do not survive as long as participants with low-risk     myeloma. Researchers at MIRT think that one reason for this is that the myeloma cells re-grow     in the time when participants are not receiving treatment because they are recovering from     high-dose chemotherapy. In this study, participants will receive several chemotherapy drugs     previously shown to be effective in myeloma, but in lower doses and in shorter cycles. It is     hoped that by giving the drugs in this way, myeloma cells will not have time to re-grow     between cycles, therefore resulting in longer remissions. This study is being done in an     attempt to improve the remission rate and the survival time for participants with high-risk     myeloma.   "
230924|NCT00869245|"     The purpose of this study is to investigate the best way to evaluate patients with chest pain     in the emergency department. It compares types of cardiac tests performed while receiving     treatment in an observation unit. Patients will either undergo cardiac MRI testing or     conventional care testing. Patients treated in the conventional care testing group will     undergo the testing their doctor determines is best for them. All patients will undergo     follow up to find out if they have had any heart related events.   "
230925|NCT00869258|"     The purpose of this study is to determine whether an experimental drug combination consisting     of Gemzar®, Taxotere®, and Xeloda®, (called GTX) when followed by radiation therapy plus     low-dose Gemzar, is safe and effective in treating advanced pancreatic cancer and to study     and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer.   "
230930|NCT00869323|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such     as rituximab, can block cancer cell growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Giving bortezomib together with rituximab may kill more     cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab     works in treating patients with post-transplant lymphoproliferative disorders.   "
230931|NCT00874757|"     The purpose of this study is to see whether Statin drugs will act as anti-inflammatories. The     investigators will study this potential anti-inflammatory activity in healthy subjects.   "
230932|NCT00874770|"     The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in     combination with pegylated interferon alpha and ribavirin, are safe and demonstrate     sufficient anti-hepatitis C virus activity.   "
230933|NCT00874783|"     Human fibroblasts and possibly other human somatic cells may be reprogrammed into induced     pluripotent stem (iPS) cells by the forced expression of transcription factors (1-5). The iPS     cells seem to share many properties with human embryonic stem cells.      Induced pluripotent stem cells potentially may be useful in the future as an unlimited source     of cells for transplantation.      The major goal of the project is to develop human iPS cells from cell cultures from skin     biopsies or the patient's hair. The iPS cells will be developed primarily for modeling     diseases and drug discovery as well as basic research, and for developing the technology that     may eventually allow the use of iPS cells for future transplantation therapy. The iPS cells     developed in the course of this application are not intended for use in transplantation     therapy. Future development of iPS cells for clinical transplantation therapies will be     subjected to the appropriate authorization by ethical and regulatory committees.   "
230945|NCT00874939|"     This study will evaluate acute symptomatic improvements in cognitive performance in healthy     elderly participants with mild-to-moderate Alzheimer's disease. A four-week pilot study will     first evaluate the CogState computerized cognitive battery in participants who are not     receiving treatment. After completion of the pilot study, participants will be randomized to     receive Placebo, Donepezil 5 mg, MK-0249 7.5 mg, and MK-0249 25 mg. After each drug     administration the participants will be given the CogState computerized cognitive battery to     assess cognitive performance. The primary hypotheses are that cognitive performance in     participants with Alzheimer's disease, or in healthy participants, is improved by the     administration of a single oral 5 mg dose of Donepezil as compared to placebo.   "
230934|NCT00874796|"     This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, multicenter     study investigating the safety, tolerability and efficacy of two oral doses of GS-9450 in     adults with chronic Hepatitis C Virus (HCV). Approximately 240 subjects 18-65 years of age     who meet study entry criteria will be randomized (in other words, selected at random, like     flipping a coin) to one of three treatment groups (80 subjects per treatment group) as     follows:GS-9450 10 mg once daily,GS-9450 40 mg once daily, or matching placebo once daily.      Following randomization, subjects will return within seven business days for a Baseline (Day     1) visit, at which time study medication will be dispensed and subjects will enter a 26 week     treatment phase. During the treatment phase, subjects will receive study drug once daily for     24 weeks and then taper off of study drug over the following 2 weeks by receiving study drug     once every other day for one week and then every 3 days for one week. Following completion of     the treatment phase, subjects will enter a 4-week off-treatment follow-up phase.   "
230935|NCT00874809|"     The main purpose of this study is to determine the number of daily basal insulin rate changes     that are needed to achieve short-term near normal glucose control in insulin pump patients     with type 2 diabetes   "
230936|NCT00874822|"     The study hypothesis is that the prevalence of obstructive sleep apnea in patients presenting     for total knee or total hip arthroplasty is higher than generally suspected. The study will     include just one arm and results will be compared to a literature control group. Patients     refered for preoperative evaluation will be screened using a standard questionnaire. Those at     high risk of obstructive sleep apnea will then undergo a formal overnight sleep study     (polysomnography).   "
230937|NCT00874835|"     The purpose of this study is to determine whether the surgical outcomes in patients     undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of     an insertion device over the traditional forceps insertion method.   "
230938|NCT00874848|"     The Phase 2 study described in this protocol will serve to evaluate the antitumor activity,     safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and     concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced     NSCLC. Additionally, this study will provide guidance for the design of more definitive     efficacy studies of Imprime PGG in NSCLC patients.   "
230939|NCT00874861|"     This is a pilot vaccine study in adults with recurrent WHO Grade II gliomas. The purpose of     this study is to test the safety and efficacy of an experimental tumor vaccine made from     peptides in combination with the study drug Poly-ICLC.      Poly-ICLC, manufactured by Oncovir, Inc., has already been received and is generally well     tolerated by subjects in earlier studies and has been shown to decrease the size of brain     tumors in some cases.      The immunological and safety data will be used to decide whether a larger study of clinical     efficacy is warranted.   "
230940|NCT00874874|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with     angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.   "
230941|NCT00874887|"     The purpose of this study is to assess if the presence of BAK in a fluoroquinolone in the     study eye affects the development of resistant bacteria on the conjunctiva based upon changes     in the surface flora over the course of 2 weeks of topical treatment in healthy adult     subjects.   "
231020|NCT00876226|"     This prospective study will determine the pharmacokinetic parameters of citalopram in 12     adult patients with short bowel syndrome. While data on the prevalence of depression in     patients with short bowel syndrome is sparse, the investigators' experience is that these     patients have a high incidence of depression and should benefit from a psychopharmacological     intervention.   "
230942|NCT00874900|"     The purpose of this study is to determine the effect on knowledge and behavior of playing an     educational asthma computer game during a pediatric Emergency Department (ED) asthma visit     among children ages 7 - 15 years. The ED cares for a high-risk population of children who     have difficulty accessing preventive care well. The addition of a computer game to usual     asthma emergency care could be a simple, effective, enjoyable way to improve patients' asthma     knowledge, beliefs, and management practices. This project has the potential to lead to     larger studies evaluating the benefit of education with and without behavioral interventions     such as motivational interviewing.      This project plans to implement and evaluate the use of a goal setting activity and the     educational asthma computer game, Quest for the Code (Starlight Starbright Children's     FoundationTM), in the ED of Seattle Children's Hospital. In a randomized trial of Spanish and     English speaking children ages 7 - 15 years receiving ED care for their asthma, the     investigators will evaluate the effects of the game on children's asthma knowledge,     attitudes, and behaviors.      The investigators aim to compare the change in asthma knowledge and locus of control after 3     months, for children who play the computerized asthma game, versus those who receive standard     care in the ED. The investigators will also compare changes in asthma severity and activity     limitations over 3 months, for children who play the asthma game without goal-setting,     children who playing the game with goal-setting, and children who receive standard care.      Overall, the investigators hypothesize that educational asthma game play by pediatric     patients with acute asthma will improve asthma knowledge, compared with standard care.   "
230943|NCT00874913|"     Obstructive sleep apnea syndrome (OSAS) is a common disease, with a prevalence evaluated     between 5 - 7% in the general population. OSAS is characterized by recurrent episodes of     partial or complete upper airway obstruction during sleep, which are nearly systematically     associated with a desaturation-reoxygenation sequence, an admitted detrimental stimulus for     the cardiovascular system. It has now been demonstrated that OSAS per se is able to generate     hypertension, atherosclerosis and autonomic dysfunction (high sympathic tone and increase in     baseline heart rate), all conditions possibly interacting with ocular vascular regulation.     OSAS has major consequences on the ocular level since it is associated with a higher     frequency of optic neuropathies, such as glaucoma and nonarteritic ischemic optic neuropathy     (NAION), both with functional severe prognosis. Most of vascular changes associated with OSAS     have been studied at the level of macrovasculature. In terms of physiopathology, the main     effects on the vascular system in OSAS are sympathetic hyperactivity, oxidative stress,     development of endothelial dysfunction, systemic inflammation and metabolic alterations such     as the appearance of insulin resistance. All these mechanisms can affect the microcirculation     of the eye, especially the optic nerve and choroid. Our hypothesis is that the eye     microvasculature is affected by OSAS, and these lesions may be detected via a reduced     autoregulation of blood flow in humans.      This project aims to demonstrate, quantify, and analyze the vascular modifications of the eye     associated with OSAS trough a comparative clinical study on glaucoma patients and OSAS     patients and matched healthy subjects for the regulation of the eye blood flow using confocal     laser Doppler flowmetry (LDF). The regulation of the ocular blood flow will be assessed using     several stimuli and measured using a new confocal LDF.   "
230944|NCT00874926|"     The aim of this international prospective, non-interventional post-marketing surveillance     study is to obtain data on treatment procedures, long-term safety and efficacy and patient     acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life     treatment conditions.   "
230948|NCT00874978|"     The purpose of this study is to evaluate the efficacy of lenalidomide treatments to achieve     haematopoietic improvement in subjects with low- or intermediate-1 risk International     Prognostic Scoring System1 (IPSS) myelodysplastic syndrome (MDS) associated with a del     (5q31-33) cytogenetic abnormality.   "
230949|NCT00874991|"     The aim of this research is to apply cardiac tissue characterization in order to assess left     ventricular function in cardiac surgical patients pre and post cardiopulmonary bypass. The     procedures to be used include a retrospective review of transesophageal images obtained     during conventional intraoperative transesophageal echocardiography (TEE) for cardiac     surgery, as well as a secondary analysis with Tissue Doppler. The results will be compared     with hemodynamic data obtained from a pulmonary artery catheter (PAC).   "
230950|NCT00875004|"     RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or     reduce side effects in patients undergoing chemotherapy for solid tumors.      PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing     chemotherapy for solid tumors.   "
230951|NCT00875017|"     The purpose of this study is to compare the absorption of dietary phosphorus following a     single dose with lanthanum carbonate (1000mg) and a single dose of sevelamer carbonate     (2400mg).   "
230952|NCT00875030|"     The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg)     Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is     the World Health Organization Reference standard for artesunate The secondary objective is to     assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).   "
230953|NCT00875043|"     The purpose of this study is to provide data that would give the investigators a better     understanding of the physiologic changes that occur and may contribute to post operative     blindness. An improved understanding may lead to the development of protocols or devices that     reduce the chance of catastrophic visual loss.   "
230954|NCT00875056|"     This study evaluates safety and tolerability of MK0683 and efficacy of MK0683 in patients     with relapsed and/or refractory FL. Exploratory purpose of this study is to evaluate efficacy     of MK0683 in patients with relapsed and/or refractory other Indolent B-NHL or MCL.   "
230955|NCT00875069|"     The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock     solution in preventing major catheter related infections in critically ill patients.   "
230990|NCT00875836|"     Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated     pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of     buspirone for reducing marijuana use in marijuana-dependent adults. A contingency management     (CM) intervention and motivational enhancement therapy (MET) will be incorporated to     encourage study engagement and retention. It is hypothesized that buspirone combined with MET     and CM will reduce the percent of marijuana-positive urine drug screen results in     marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.   "
231021|NCT00876252|"     Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study     (approximately 50 centers) in approximately 9 countries. Proposed start date is December     2008. The study duration per patient is estimated to be 90 days. Overall study duration is     estimated to be 12-18 months.   "
230956|NCT00875082|"     Airway smooth muscle cell layer thickening and sub epithelial fibrosis, key allergen-induced     airway remodelling features not modulated by corticosteroids, are reversible by CysLT1     receptor blockade therapy in animals. No data are available, at the present, about the     potential effect of LTs receptor antagonists on airway remodelling in asthmatic children.      In the present study, the investigators aim to assess whether the addition of montelukast to     ICS in mild asthmatic children to inhibit the release of MMP-9, TIMP-1, MMP-12, MMP-9/TIMP1     ratio, procollagen type I C-terminal peptide (PICP) and TGF-beta in the airway fluid     collected by induced sputum in asthmatic children. 30-40 atopic children with mild persistent     asthma.      Children with asthma will be recruited and evaluated with a real life open label trial: they     will be randomised into two groups at first visit (T1): 1) group A: in these patients     montelukast tablets 5 mg and as needed beta agonist will be administered; 2) group B: in     these patients beta agonist therapy only.      All children will be evaluated after 8 weeks (T2). They will be tested for lung function,     FeNO, metalloproteinase (MMP)-9, MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1),     procollagen type I C-terminal peptide (PICP) and TGF-beta1 levels in sputum.   "
230957|NCT00875407|"     Context. Nuclear imaging plays a central role in management of chromaffin-tissue derived     tumors because tumor cells exhibit peptide receptors and proteins involved in metabolism that     can be targeted with specific radiopharmaceutics. Recently, over expression dopamine-receptor     D2 isoforms has been found in endocrine tumors.      Objective. The aim of the present study is to evaluate the feasibility of 123I-IBZM (a D2     agonist radiolabelled with 123I) in patients with PHEO and/or PGL. Diagnostic accuracy will     be also compared to traditional SPECT imaging procedures.   "
230958|NCT00875420|"     The purpose of this study is to determine whether RAD1901 is effective in decreasing hot     flashes in postmenopausal women.   "
230959|NCT00875433|"     A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the     effectiveness of afatinib (BIBW 2992) in treating certain cancers. Cancers studied will     include glioblastoma and cancers which have spread to the brain (metastases).   "
230960|NCT00875446|"     The drug being tested in this study is GSK1223249. It is being developed by GlaxoSmithKline     to treat symptoms in patients with Amyotrophic Lateral Sclerosis (ALS).      The drug works by inhibiting the protein that prevents nerve growth.      This will be the first time the drug will be given to man. The trial is expected to involve     approximately 76 patients. The study objective is to investigate the tolerability, safety and     the way the body handles GSK1223249 after a range of single doses or repeat dose escalation     in patients with ALS.   "
230961|NCT00875459|"     Follow-on study to the VIAject™ 06J study to evaluate the long-term safety and efficacy of     VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 1     diabetes mellitus.      The VIAject™ 06J study is the efficacy and safety study for insulin VIAject™ to demonstrate     equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin and     regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for     VIAject™ in comparison to human insulin   "
230962|NCT00875472|"     The purpose of this study is to assess the effects of peer influences on snack purchases in     adolescents. During the session teens will be given a certain amount of money to use to     purchase foods and beverages in a hypothetical convenience store setting.      The investigators hypothesize that overweight youth will be less responsive to own-price     elasticity for high calorie foods and less likely to show cross price elasticity for low     calorie foods when the price of the high calorie for nutrient foods increases. The     investigators also predict that overweight youth will show more cross price elasticity for     low calorie foods when in the presence of peers; whereas lean youth's food purchases and     price sensitivity will not be affected by the presence of peers.   "
232573|NCT00897624|"     RATIONALE: Studying samples of bone marrow and blood from patients with cancer may help     doctors find out the extent of disease.      PURPOSE: This research study is collecting bone marrow and blood samples from patients with     metastatic choroid melanoma.   "
230963|NCT00875485|"     This study will evaluate the immune response against Hepatitis-A (HAV) and Hepatitis B     surface (HBs) antigen in healthy subjects aged 12 to 15 years (at the time of primary     vaccination), who received vaccination course with GSK Biologicals' Twinrix Adult and Twinrix     Junior vaccine, approximately 10 years ago in the primary study. The subjects will be invited     for blood sampling at 11, 12, 13, 14 and 15 years after primary vaccination to evaluate the     persistence of immune response. For subjects detected with decreased immunity, the presence     of immune memory against hepatitis A & B antigens will be investigated by the administration     of a challenge dose of the appropriate vaccine 6 to 12 months after the Year 15 follow-up     time-point.      No new subjects will be recruited during this booster phase of the study.   "
230964|NCT00875498|"     The purpose of this study is to determine whether the iTBS is an effective treatment of the     negative symptoms of schizophrenia.   "
230965|NCT00875511|"     The study seeks to discover whether peer rejection increases the value of food relative to     peer interaction in overweight individuals. After playing a computer game that randomly     simulates peer rejection or peer acceptance, participants will play another computer game     that will assess the value of food and social interactions.      Overweight individuals may be more likely to resort to food in moments of distress and less     likely to choose to interact with a peer to reestablish their sense of belongingness.   "
230966|NCT00875524|"     This trial will evaluate the use of a tetravalent vaccine against dengue.      Primary objectives:        -  To describe the immune response to dengue before and after each vaccination with          tetravalent dengue vaccine in adults, adolescents, and children.        -  To evaluate the safety of each vaccination with sanofi pasteur's tetravalent dengue          vaccine in 4 age cohorts.        -  To evaluate the persistence of antibodies against dengue during 5 years after the first          vaccination with sanofi pasteur's tetravalent dengue vaccine in the four age cohorts.   "
231006|NCT00876044|"     The primary objective of this study is to evaluate the effects of aflibercept on the QTc     interval in cancer patients.      Secondary objectives are to evaluate the effects of aflibercept on other electrocardiogram     (ECG) parameters, clinical safety and pharmakokinetic (PK) parameters.   "
231007|NCT00876057|"     The purpose of this study is to determine whether psychological well-being, recovery and     sexuality differs in women undergoing subtotal and total abdominal hysterectomy.      Se also Detailed Description for additional study.   "
230967|NCT00875537|"     Burning mouth syndrome (BMS) is characterized by a bilateral burning sensation in the     anterior tongue, hard palate and lips in the absence of any clinical or laboratory findings.     The term syndrome implicates the simultaneous presence of oral dryness (xerostomia) and     altered taste (dysgeusia) in addition to the burning sensation in the oral mucosa. BMS is     most often seen in women and is more frequent during menopause. The etiology and pathogenesis     are still unclear but recent studies suggest that BMS is a neuropathic pain condition.      The objectives of the study are:        -  To clarify potential neurogenic mechanisms behind BMS using immunohistochemistry (IH) to          characterize the localization and distribution of peripheral nerve fibres, neuropeptides          like substance P, calcitonin gene-related peptide, nerve growth factor, nerve growth          factor receptor, PGP 9.5 neuronal marker and TRPV1 as well as inflammatory/structural          changes.        -  To perform a randomized double blind cross-over intervention study to examine the          efficacy and safety of topical application of capsaicin oral gel (on the tongue) to          relieve the burning sensation in patients with BMS.   "
230968|NCT00875550|"     The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in     intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects. The key     study objectives are:        -  To characterize the loading and maintenance dosing of DEX by age group and overall          medical condition of pediatric subjects        -  To evaluate the safety and efficacy of loading and maintenance infusions for sedation in          initially intubated and mechanically ventilated PICU subjects        -  To explore the exposure-response relationship between dose of DEX and clinical measures          of sedation and safety   "
230969|NCT00875563|"     The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation     approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA     Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.   "
230970|NCT00875576|"     The objective of this study is to directly compare the effects of parents and friends on     overweight and non-overweight children and adolescents' food intake and food selection using     a cross-sectional design. Overweight and non-overweight children (5-6 year-old) and     adolescents (13-14 year-old) will share a meal with a friend and with a parent on separate     occasions. Participants' food selection and the amount of food they consumed will be compared     across conditions.      Hypothesis 1: The investigators hypothesize that overweight children and adolescents will     select more unhealthy food items and eat more in the presence of an overweight friend than     when eating with a lean friend; whereas lean participants eating with an overweight friend     will eat a similar amount of food than lean youth eating with a lean friend.      Hypothesis 2: The investigators predict that overweight children and adolescents (but not     lean children and teens) will consume more food in the presence of their mother than in the     presence of a friend.      Hypothesis 3: The investigators also predict that overweight youth's energy intake will be     related to parental prompts.      Hypothesis 4: The investigators expect greater similarities in terms of food selection and     food intake between adolescents and their friend than between adolescents and their parent.   "
230971|NCT00875589|"     The study investigates whether the use of eye movement recordings can provide a reliable     diagnostic of previously undiagnosed mild traumatic brain injury (blast and impact) in     Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans.   "
230972|NCT00875602|"     Evaluation of continuous monitoring device on patients Risk during hospitalization and nurse     satisfaction level.   "
230973|NCT00875615|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor. Infusing chemotherapy directly into     the liver and giving it together with sorafenib may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of infusing cisplatin or     carboplatin directly into the liver and giving it together with sorafenib in treating     patients with liver cancer that cannot be removed by surgery.   "
230974|NCT00875628|"     Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple     oral administrations of PF-00868554 in Japanese healthy adult volunteers.   "
232574|NCT00897637|"     This laboratory study is using gene expression profiling to identify different categories of     Wilms tumors. Studying the genes expressed in samples of tumor tissue from patients with     cancer may help doctors identify biomarkers related to cancer.   "
230975|NCT00875641|"     This observational cohort study, conducted through two existing large administrative health     databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety     profile regarding lack of any association of intussusception with Rotarix within 60 days of     vaccination in a real life setting (routine use) in the US. This study will also include     monitoring of Kawasaki disease, convulsions, hospitalizations due to acute lower respiratory     tract infections and all-cause deaths within 60-days of vaccination.      This study involves three cohorts, one exposed and two control cohorts: infants who receive     Rotarix (Exposed cohort) and infants who receive IPV vaccination (Unexposed cohort A and B).      This is a combined prospective and retrospective cohort study. Prospective component of the     study identifies and compares study outcomes following Rotarix and IPV vaccination in the     Exposed cohort and Unexposed cohort A, respectively.      Retrospective component of the study identifies and compares study outcomes following IPV     vaccination in the Unexposed cohort B.   "
230976|NCT00875654|"     The main objective of the study is to evaluate feasibility and tolerance of the intravenous     injection of autologous mesenchymal stem cells for patients presenting an ischemic stroke     (less than 6 weeks).   "
230977|NCT00875667|"     To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients     with relapsed or refractory Mantle Cell Lymphoma.   "
231008|NCT00876070|"     This is a retrospective medical record abstraction study. It is a review and evaluation of up     to 300 metastatic breast cancer patients treated with Abraxane or other taxanes such as     paclitaxel and docetaxel to determine the overall cost of care for Abraxane compared to other     taxanes in the first-line metastatic cancer setting and the cost of care for Abraxane     compared to other taxanes when broken down by individual components of cost. In addition, the     investigators will review the following patient outcomes: response rate, duration of therapy,     toxicity, and survival.   "
230978|NCT00875680|"     Obstructive Sleep Apnea Syndrome (OSAS) is a common condition that leads to daytime     sleepiness and loss of vigilance and, in addition, increased risk of cardiovascular events.     The most effective treatment consists in ventilation by mask with continuous positive airway     pressure (CPAP), that prevents collapse of the upper airway. However the degree of     collapsibility of the pharynx may vary in relation to position, sleep stage, or alcohol or     sedative consumption. Thus, CPAP treatment (invented in 1981) has evolved with the     development of more sophisticated equipment that permits adapted variations in pressure     levels (autoCPAP) with the objective adjusted pressure to avoid airways obstruction with     minimal pressure.      Different models of autoCPAP function with different signals and event detection algorithms     with different modes of reaction to events. These machines are marketed with CE     certification, that guarantees electrical security, but there is to date, no requirement for     pre-marketing clinical validation. Nonetheless inadequate treatment may leave patients at     risk of accidents and cardiovascular events. These machines can be bench tested using test     equipment that can measure with accuracy the response to simulated events, but the testing     equipment cannot simulate the diversity of clinical situations, nor the residual level of     microarousals that may persist. Thus these bench tests need to be supplemented by clinical     studies. The investigators objective is to test the efficacy of these machines on residual     sleep-related events during a one night autotitration polysomnography. We develop a     prospective, multicentre, non randomised study with autotitration polysomnography only for     one night. These clinical results will be compared with the results of bench tests in order     to evaluate the pertinence of the bench tests and their eventual utility to simplify clinical     evaluation. The perspective of developing a reliable testing protocol may eventually play a     role in the certification of these machines.   "
230979|NCT00875693|"     This open-label Phase I study is designed to determine the maximum tolerated dose (MTD) for     CPX-351 followed by a reduced intensity conditioning regimen and incorporates a     dose-escalation schedule that sequentially enrolls 6 dosing cohorts. After the determination     of the MTD, the investigator reserves the option to enroll up to 10 additional subjects in an     expanded safety cohort(s) at the MTD.      Refractory and relapsed AML patients who meet standard institutional criteria to undergo     sequential induction/reduced intensity conditioning allogeneic transplants will be offered a     transplant from a related or unrelated donor (full match or 1 antigen mismatch). Cord blood     transplants will not be used in this study.   "
230980|NCT00875706|"     This study aimed to explore the feasibility of an educational intervention to strengthen     workplace learning systems in four VA Community Living Centers (CLCs).   "
230981|NCT00875719|"     The purpose of this study is to compare differences in oxygen delivery between portable     oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs     are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized,     single-blind clinical trial.   "
230982|NCT00875732|"     The aim of the study is to see if biventricular pacemakers offer any advantage over     conventional pacemakers in patients with heart failure who require pacemakers. The endpoints     will be the 6 minute walking distance along with markers of cardiovascular function.      The investigators' hypothesis is that biventricular pacing is preferable to conventional     pacing in these heart failure patients.   "
230983|NCT00875745|"     The purpose of this study is to test the safety of sorafenib and vorinostat when given     together to see what effects (good and bad) it has on the patient and their acute myeloid     leukemia (AML) or myelodysplastic syndrome (MDS). This study is also being done to find the     highest dose of sorafenib and vorinostat that can be given together without causing severe     side effects.   "
230984|NCT00875758|"     Intraventricular hemorrhage remains the most frequent, severe neurological complication of     prematurity, occurring in 25-30% of preterm infants. Post-hemorrhagic ventricular dilation     (PHVD) occurs in 25-50% of those infants, with over half requiring ventriculoperitoneal     shunts. When suboptimally untreated, PVHD results in a 3-4 fold increase in     neurodevelopmental delay. Despite the lifelong impact of PHVD on quality of life, little     research has been done over the past 20 years to improve patient outcomes.      The CENTRAL HYPOTHESIS of this project is that early treatment of PHVD will reduce     shunt-dependence and improve neurodevelopmental outcome in preterm infants.   "
230985|NCT00875771|"     The purpose of this study is to determine efficacy and safety of the biweekly scheme with     Capecitabine and Irinotecan, plus bevacizumab in patients with metastatic colorectal cancer.   "
230986|NCT00875784|"     This study will evaluate the exposure of sumatriptan after administration of TREXIMA     (sumatriptan 85mg/naproxen sodium 500mg) followed by a subcutaneous IMITREX injection (4mg or     6mg) 2 hours later compared to administration of a IMITREX 100mg tablet followed by a IMITREX     100mg tablet 2 hours later.   "
230987|NCT00875797|"     Glutamine is a major fuel for the intestinal tract and immune cells and therefore affects the     intestinal permeability (IP) and infection rate at critically ill patients. The preferential     route of glutamine supplementation at critically ill patients still remains open. Therefore     the researchers will investigate IP, infection rate and treatment outcome at patients     supplemented with either parenteral or enteral glutamine.      A prospective randomized single blind study is performed at mechanically ventilated. Patients     were randomly assigned to either parenteral (group P) or enteral (group E) glutamine     supplemented group. Early enteral feeding is started in both groups. Patients are/will be     treated with glutamine for five days. IP will be measured using lactulose/mannitol test (L/M)     on the fourth day.   "
232605|NCT00891449|"     Space flight simulation study to study effects of microgravity through bedrest coupled with     flight exercise counter-measures.   "
230988|NCT00875810|"     Prestige artificial disc replacement is an alternative treatment option with 16 years of     experience addressing the unmet needs of surgical fusion interventions. Previous studies on     the PRESTIGE® cervical disc have proven the safety and effectiveness of artificial disc     surgery with level I evidence.      The PRESTIGE Observational Study is intended to collect prospectively observational data     primarily on the Quality of Life (QoL).   "
230989|NCT00875823|"     The purpose of this study is to collect medical information from a large number of patients     in many areas of the world with primary hyperoxaluria. This medical information will be     entered into a registry to help the investigators compare similarities and differences in     patients and their symptoms. The more patients that the investigators are able to enter into     the registry, the more the investigators will be able to understand primary hyperoxaluria and     learn better ways of treating patients with this disease. It is the investigators hope that     by entering as many patients with PH as possible, the information that the investigators     collect may help physicians diagnose patients sooner and determine what treatments may work     best on patients with similar medical or genetic backgrounds.   "
231009|NCT00876083|"     The purpose of this study is to obtain data on the safety and efficacy of Ultravist     application in usual daily use.The radiologist will administer the contrast medium to the     patient as he/she would have done without the study. No other examinations will be performed     than would have been done routinely.   "
230991|NCT00875849|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances     to them. Giving chemotherapy together with radiation therapy and cetuximab may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation     therapy and cetuximab works in treating patients with head and neck cancer.   "
230992|NCT00875862|"     Research study to determine if putting local anesthetic through a tiny tube next to the     nerves that go to the shoulder will improve shoulder range-of-motion following the shoulder     procedure performed on the frozen shoulder. It will also help determine if patients have a     higher quality-of-life and less pain, require fewer pain pills, experience fewer sleep     disturbances, and are more satisfied with their post-procedure pain control.   "
230993|NCT00875875|"     The study will compare durations of diarrhea among subjects who report to clinic for     treatment and who receive either:        1. standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR        2. a single 600 mg dose of rifaximin daily for 3 days.   "
230994|NCT00875888|"     This study will assess the influence of the High Cut-Off (HCO) CVVHD treatment on the disease     progression in septic patients. The primary aim of the study is to evaluate whether HCO CVVHD     leads to a significant improvement of the hemodynamic status (mean arterial pressure,     vasopressor requirements) in septic patients in comparison to CVVHD treatment with     conventional high-flux filters. For the HCO-group the investigators expect a 50% lower dosage     of vasopressors needed to maintain an adequate organ perfusion.   "
230995|NCT00875901|"     This is a research study to determine if hypofractionated image guided radiation therapy     (hypoIGRT) with proton therapy is a good way to treat early stage lung tumors for patients     who will not have surgery. HypoIGRT delivers higher daily doses of radiation over a shorter     period of time compared with conventional radiation. This is thought to deliver a more lethal     dose of radiation to the tumor and is more convenient with treatment being completed within     2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.   "
230996|NCT00875914|"     The MAGMA-AVNRT study compares two different methods of handling the ablation catheters for     av-node-reentry-tachycardia with regard to x-ray dose, safety and success: manually guided vs     magnetically navigated RF-catheter.   "
230997|NCT00875927|"     Users of Breezy candy will utilize the candy's abrasiveness to scrape tongue surface. The     scraping action together with the release of compounds contained inside the abrasive     microcapsules will result in significant reduction of oral halitosis.   "
230998|NCT00875940|"     The study hypothesis is that a quantitative index can be derived from Tc-99m myocardial     perfusion scans that accurately identifies the presence of left ventricular hypertrophy and     pulmonary hypertension. Echocardiography provides the reference standard.   "
230999|NCT00875953|"     Neck dissection is the main technique used by head and neck surgeons to treat known or     suspected metastatic cancer to the neck. The traditional radical neck dissection was     effective at treating metastatic cancer to the neck however the downside to this technique     was significant morbidity. Since the early 1960's there has been several proposed techniques     to treat metastatic head and neck cancer that involves preserving important anatomical     structures in the neck. The disadvantage to these techniques are that they require meticulous     dissection and can lead to bleeding and an increase in operative time. One particular tool     that has been proposed in other surgical subspecialties, including head and neck surgery, is     the harmonic scalpel. Using this tool, tissue dissection and vessel occlusion at the same     time can occur with a reduced thermal damage to the surrounding tissue when compared to     traditional cautery. In this study, our purpose is to determine if the harmonic scalpel will     lead to a decrease in blood loss and operative time in patients undergoing a modified radical     neck dissection compared to electrocautery.      Hypothesis: Use of the harmonic scalpel as a surgical adjunct will reduce operative time for     neck dissection and will reduce intraoperative blood loss.   "
231000|NCT00875966|"     The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral     suspension.   "
231075|NCT00876954|"     The investigators hypothesize that preoperative hyperthermia improves postoperative     complications and compare a placebo group with standard thermoregulatory management     (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core     temperature) in a randomized, single blinded, controlled trial.   "
231001|NCT00875979|"     This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study     designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab     emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with     pertuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive locally     advanced or metastatic breast cancer who had previously received trastuzumab.   "
231002|NCT00875992|"     In many cases, the existing locking bolts and screws in intramedullary nails do not provide     sufficient stability. The play between screw and nail can result in loss of reduction and the     instability due to the interfragmentary movement can result in malunions or nonunions.     Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to     enhance axial and angular fracture stability. ASLS provides angular-stable fixation between     nails and screws with resorbable sleeves used as dowels in the nail locking holes.     Preliminary results of a pre-study show a trend towards reduced time to pain-free full weight     bearing in patients being treated with ASLS. This hypothesis will be tested in the present     randomized controlled study.   "
231003|NCT00876005|"     This is a study to see whether increasing the oxygen concentration during and after a     cesarean section decreases the infection rate.   "
231004|NCT00876018|"     The purpose of this study is to evaluate the effect of nutritional supplement on physical     performance measures of apparently healthy school going children in India.   "
231005|NCT00876031|"     The purpose of this study is to investigate whether the addition of oral maintenance     chemotherapy with O-TIE (Etoposide, Idarubicin, Trofosfamide) for 6 months improves the event     free survival (EFS) in patients with localised high-risk RMS and RMS-like Soft Tissue     Sarcoma.   "
231010|NCT00876096|"     Invasive fungal infections have a major impact on the morbidity and mortality of     immunocompromised patients, including patients with hematological malignancies, neutropenic     patients, human immunodeficiency virus infected patients, diabetics, solid organ transplanted     patients and patients admitted in an intensive care unit.      The survival of these patients depends on early diagnosis and prompt appropriate antifungal     treatment. The early diagnosis of these infections is difficult because of the lack of     sensitive test methods, notably blood cultures. For these reasons, the investigators decided     to develop a real-time PCR (Polymerase Chain Reaction) assay on blood samples. It should     allow rapid response to establish a positive or negative diagnosis of invasive fungal     infection, could contribute strongly to the decision of treating using antifungals, and     should monitor the effectiveness and the optimization of antifungal prescriptions.      The investigators' objectives are: First, to validate an extraction method from blood     infected by fungi species. Secondly, the investigators want to develop three real-time PCR: A     fungal real-time PCR able to detect most fungal species; a real-time PCR targetting Candida     albicans and Aspergillus fumigatus which are two clinically important pathogens. Then blood     samples of patients (classified according to EORTC consensus) will be collected during the     study in order to evaluate and validate our method on clinical samples. Results will allow     the investigators to determine the sensitivity, specificity and reproducibility, negative and     predictive values.      Overall, the investigators' work aims to evaluate the clinical impact of real-time PCR in the     early diagnosis of invasive fungal infections and on the initiation or stopping of antifungal     therapy. The economic impact resulting from the use of this method will be evaluated.   "
231011|NCT00876109|"     This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety,     tolerability, and pharmacokinetics of orally administered GDC-0941 administered once daily     (QD) and twice daily (BID) in the treatment of advanced or metastatic solid tumors.   "
231012|NCT00876122|"     This is an open-label, Phase I, dose-escalation study using a 3 + 3 design to assess the     safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered QD.     This study will include patients with locally advanced or metastatic solid tumors, NHL, or     multiple myeloma (MM) (expansion stage only) for which standard therapy either does not exist     or has proven ineffective or intolerable.   "
231013|NCT00876135|"     The prevalence of airway hyperresponsiveness (AHR) is very high in elite swimmers, reaching     80% in certain studies. Repeated Chlorine-derivatives exposure may be a major causative     factor for its development. Asthma diagnosis is generally made on the basis of clinical     characteristics. The demonstration of a variable bronchial obstruction through positive     expiratory flow reversibility to a bronchodilator, spontaneous variations of airway     obstruction or a positive provocation test (methacholine, eucapnic voluntary hyperpnoea…) is     necessary to avoid false diagnosis. Currently asthma treatment in swimmers is the same as in     the general population. A short-acting bronchodilator is often prescribed to avoid occasional     symptoms, combined with an inhaled corticosteroid or an antagonist of Leukotriene if asthma     symptoms are persistent. Previous studies have shown a reduced efficiency for asthma     medication in elite athletes compared with non-athletes. The specific response to different     medications remains to be studied in athletes. The effects of a short-acting bronchodilator     in swimmers with AHR, especially when asymptomatic, on pulmonary function and performance     have not yet been studied. Moreover, the significance of a positive bronchial provocation     test remains to be studied in asymptomatic swimmers with AHR.   "
231014|NCT00876148|"     The purpose of this study is to evaluate the risk of hepatitis B reactivation in patients     undergoing allografting.   "
231076|NCT00876967|"     The purpose of this study is to determinate if there is a difference in performance provided     by three laryngoscope blades: plastic single use, metallic single use and metallic reusable     blades.   "
231015|NCT00876161|"     This study will evaluate the safety, tolerability, and systemic exposure of an experimental     influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is     administered via oral inhalation using a special device. Study participants will include     healthy non-smoking males and females, ages 18-65. They will be given either DAS181 or     placebo. Participants will remain in the clinic overnight to be watched for health changes     for 24 hours after receiving the medication. Study procedures include: physical exams, chest     x-rays, ECGs, lung function tests, collection of blood and urine samples, and throat swabs.     Follow-up visits will occur on study days 2, 7, 14 and 30.   "
231016|NCT00876174|"     The objective of this pilot project is to investigate the prognostic criteria for sensitivity     of Chronic Hepatitis C (CHC) Genotype 1, patients to IFNa treatment. Signal transduction in     peripheral blood mononuclear cell (PBMC) of control groups will be compared with that of CHC     patients. For this study, 20 patients with Hepatitis C virus (HCV) infection who are to     undergo standard antiviral therapy and 10 healthy donors (significant others of the HCV     subject) will be enrolled. Signal transduction will be studied in peripheral blood of CHC     subjects before the treatment, after 1 and 3 months of treatment, and 4-6 months following     the completion of treatment.   "
231017|NCT00876187|"     The purpose of this study is to evaluate the efficacy and safety of multiple doses of     tanezumab administered every 8 weeks in treating chronic low back pain. Tanezumab is a     monoclonal antibody directed against human nerve growth factor.   "
231018|NCT00876200|"     The Williams-Beuren syndrome (WBS) is a sporadic congenital disorder characterized by a     multisystem developmental impairment. This syndrome is caused by a microdeletion in     chromosome 7q11.23 that encompasses loss of the elastin locus.      Elastin, which is part of the extracellular matrix, controls proliferation of vascular smooth     muscle cells (VSMCs) and stabilizes arterial structure. Loss of elastin gene in WBS patients     has been claimed to provide a biological basis for the abnormal elastic fibre properties     leading to cardiovascular abnormalities like supravalvular aortic stenosis (SVAS),     hypertension, arteriosclerosis and stenosis in more than 50% of WBS children.      These cardiovascular pathologies result in important consequences and neither curative nor     preventive medicinal treatments exist at this time. Surgery is needed in more than half     cases, while it is often leading to complications.      Minoxidil is a well-known antihypertensive drug used in adults and children. Furthermore,     according to animal studies, minoxidil seems to increase arterial elastin content by     decreasing elastase activity in these tissues. Other data demonstrate that minoxidil     specifically stimulate elastin synthesis.      Working Hypothesis:If insufficient elastin synthesis leads to vascular complications and     arterial hypertension in children with WBS, restoration of sufficient quantity of elastin     should then result in prevention or inhibition of vascular malformations and improvement in     arterial tension. Therefore, as a pharmacological agent capable to stimulate elastin     expression, minoxidil might be a useful drug for the treatment of abnormal elastin metabolism     in WBS children.      Objective:To evaluate the efficacy of minoxidil on cardiovascular structure in children with     Williams Beuren syndrome.      Methodology: randomized controlled trial on two parallel group (23 patients in each arm) Main     criterion:variation of carotid Intima-media thickness (IMT) before and after 12 months of     treatment with Minoxidil versus placebo Secondary intermediate criteria of the vascular     properties are arterial stiffness, cardiac and renal stenosis, arterial tension.      Total study duration:30 months including a 12 month-recruitment period   "
231019|NCT00876213|"     The aim of this proposal is to dissect the mechanisms controlling gastric emptying, appetite     and food intake in humans, and to obtain new knowledge to fight obesity on a pharmacological     basis.   "
231038|NCT00876473|"     The aim of this study is to evaluate the performance, the tolerability and the efficacy on     gas-exchange of different CPAP (Continuous Positive Airway Pressure) systems.   "
231022|NCT00876265|"     This was a study to find out how an investigational product, Belotero, compares to a second     product in people with facial wrinkles, such as nasolabial folds. Nasolabial folds are     wrinkles on the face that go from the outside of the nostrils to the edges of the mouth.     Additionally, this study determined Belotero is safe and tolerable and corrects facial     wrinkles, such as nasolabial folds.   "
231023|NCT00876278|"     Pilot study to evaluate usability of Mesotest II for assessment of night driving capacity of     pseudo-phakic patients implanted with aspheric monofocal posterior chamber IOL *AT.Smart     46LC.      Target Criterion:      Measurement of contrast sensitivity and sensitivity to light under mesopic conditions     (Mesotest II, Oculus).   "
231024|NCT00876291|"     Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria     and maintaining the integrity of the gut mucosal barrier. The beneficial effects of     probiotics have been previously studied in adult patients with IBS. Even though most of the     studies demonstrate efficacy, other studies do not support these observations. Few studies     addresses the efficacy of probiotics in children with IBS. The goal of the present study was     to determine whether oral administration of the probiotic Lactobacillus GG under randomized,     double-blind, placebo-controlled conditions would improve symptoms of children with abdominal     pain.   "
231025|NCT00876304|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     multiple ascending doses of PF-04802540 administered orally to subjects with schizophrenia.   "
231026|NCT00876317|"     The purpose of this study is to evaluate the efficacy and safety two oral doses of etoricoxib     (60 mg and 90 mg) daily in acute soft tissue rheumatism affecting the shoulder.   "
231027|NCT00876330|"     The purpose of this study is to evaluate the impact of electronic health record clinical     decision support and automated telephone outreach on antihypertensive and lipid-lowering     therapy in ambulatory care.   "
231028|NCT00876343|"     To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy     co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a     serotonin-norepinephrine reuptake inhibitor (SNRI) in patients with major depressive     disorder.   "
231045|NCT00876564|"     The purpose of this study is to improve performance, Stavanger University Hospital (SUH)     reorganized key system structures and introduced in 2009 mandatory documentation of field     Revised Trauma Score on trauma patients, tiered trauma team activation and new guidelines for     field triage. Through a before and after study, the investigators aim to measure how the     quality improvement initiative will influence structure, process and outcomes variables.   "
231029|NCT00876356|"     Conjugated linoleic acids (CLA) are naturally occurring free fatty acids derived from the     tissues and milk of ruminant animals such as cows. CLA has multiple biological properties     including regulation of metabolism and immune processes, including tissue inflammation.     Asthma symptoms are caused by irritation and inflammation of the airways. Our hypothesis was     that CLA may reduce airway inflammation in asthma and thus reduce asthma symptoms. The aim of     this pilot study was to investigate the efficacy and safety of CLA as a dietary supplement in     mild asthma. Subjects will be assigned to take CLA dietary supplements or placebo (olive oil)     for 12 weeks in addition to their usual asthma treatment. They will be monitored for asthma     symptoms, side effects, lung function and blood markers of inflammation.   "
231031|NCT00876382|"     A retrospective medical record abstraction study of at least 200 advanced renal cell     carcinoma patients treated in the following settings:        -  Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as          second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line          therapy (about 100 patients)        -  Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as          first-line therapy followed by Sunitinib (Sutent) as second-line therapy (about 100          patients)   "
231032|NCT00876395|"     The purpose of this Phase III study is to confirm the value of adding everolimus to weekly     paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.   "
231033|NCT00876408|"     This will be a retrospective review of 30 patients with unknown primary cancer who have had     commercially available RT-PCR assays performed on biopsied tumors, in order to determine if     the assay results are consistent with clinical features and useful for planning initial     therapy or changing therapy.   "
231034|NCT00876421|"     The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539     in patients with overactive bladder.   "
231035|NCT00876434|"     Background:        -  Uveitis is an inflammatory condition in which the patient's own immune system attacks          the eye, causing eye inflammation and vision loss. Patients with uveitis may be treated          with immunosuppressive medications to reduce the inflammation and prevent vision loss.        -  Sirolimus is an immunosuppressive medication that is approved by the U.S. Food and Drug          Administration (FDA) to prevent organ rejection following a kidney transplant.          Researchers think that sirolimus may affect the part of the immune system that may be an          important cause of uveitis, and may decrease the inflammation that causes uveitis.        -  In this study, sirolimus will be given as an injection under the outer layer of your          eye. The FDA has permitted the investigational use of sirolimus for this study.      Objectives:        -  To determine if subconjunctival injection of sirolimus is safe for treatment of uveitis.        -  To see if sirolimus is an effective treatment for uveitis.      Eligibility:        -  Patients 18 years of age and older with active uveitis in one or both eyes. If a patient          has uveitis in both eyes, the one in which the inflammation is worse will be treated          during the study. The vision in the study eye must be at least 20/400.        -  Patients must have good liver function, and must be willing to practice sun protection          measures for 2 weeks following the treatment.      Design:        -  Treatment with sirolimus in the study eye:        -  Antibiotic and numbing eye drops will be given before the sirolimus injection.        -  1 dose of sirolimus will be injected directly into the subconjunctiva (white part of the          eye).        -  Antibiotic drops will be given for topical application 3 times per day for 2 days after          the injection.        -  Patients will be followed for 16 weeks after sirolimus injection (initial visit and          follow-up visits in Weeks 2, 4, 8, 12, and 16).        -  Evaluations during the treatment period and follow-up visits:        -  Physical examination, including vital signs and body weight checks, and pregnancy test          for women who can become pregnant.        -  Full medical and ophthalmic history, involving questionnaires and discussion with          researchers.        -  Eye examination, dilation, and photography, including measurements of retinal thickness          and fluorescent dye tests of blood flow in the eye.        -  Blood and urine tests.        -  Because of the increased risk of skin cancer associated with sirolimus, patients ...   "
231036|NCT00876447|"     The purpose of this study is to assess the long-term safety and effectiveness of botulinum     toxin type A on patients with overactive bladder as a result of spinal cord injury or     multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376     and NCT00461292).   "
231037|NCT00876460|"     To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas     recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60     mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with     stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the     recommended dose for the Phase II trial.   "
231040|NCT00876499|"     This goal of this research study is to learn more about fatigue, sleep quality, and other     symptoms in patients with primary brain tumors who are being treated with radiation therapy.      Objectives:      PRIMARY OBJECTIVE:      1. The primary objective of this study is to provide preliminary data describing the severity     and change over time in fatigue using the Brief Fatigue Inventory (BFI) during radiation     therapy for patients with primary gliomas.      SECONDARY OBJECTIVES:        1. To evaluate longitudinal changes in the severity of symptoms and the mean symptom burden          as measured by the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) and          mood using the Profile of Mood States (POMS) during radiation therapy.        2. To assess alterations in circadian rhythms using actigraphy during radiation therapy and          the association with sleep quality tools - Pittsburgh Sleep Quality Index (PSQI) and the          Epworth Sleepiness Scale(ESS), and the severity of BFI and MDASI-BT scores over time.        3. To explore the association between the levels of salivary hormones (melatonin and          cortisol) and the occurrence of fatigue and symptom burden.   "
231041|NCT00876512|"     Dual antiplatelet therapy with aspirin and thienopyridines decreases the rate of stent     thrombosis in patients undergoing percutaneous coronary intervention (PCI). However, despite     intensified antiplatelet treatment, some of the patients undergoing PCI develop thrombotic     stent occlusion, suggesting incomplete platelet inhibition due to thienopyridine resistance.     The present study is designed in order to clarify the influence of CYP2C19 genetic     polymorphism on the several biomarkers for platelet activation in Japanese patients treated     with thienopyridines undergoing elective PCI.   "
231042|NCT00876525|"     This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve     when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.   "
231043|NCT00876538|"     The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores     after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia     scores.   "
231046|NCT00876577|"     This study is a local, prospective, open-label, company-sponsored, non interventional,     multi-center study. Patients documented must suffer from an acute exacerbation of chronic     bronchitis and take at least one dose of Moxifloxacin injection.The primary objective is to     obtain clinical effectiveness and safety data of Moxifloxacin injection in the treatment of     acute exacerbations of chronic bronchitis in patients in whom Moxifloxacin was routinely     prescribed. The secondary objective is to find out the possible correlation between the risk     factors (sex, smoking, number of previous exacerbations, etc) and AECB, the different     treatment effectiveness according to Anthonisen classification. This study will also collect     the data of pathogens by sputum culture and the defervescence time of Moxifloxacin injection     in treating Acute Exacerbations of Chronic Bronchitis (AECB).   "
231047|NCT00876590|"     According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of     fingertips as samples to evaluate the accuracy of portable BGM.   "
231048|NCT00876603|"     There is no difference in surgical outcomes for patients suffering from cervical spondylotic     myelopathy treated with anterior decompression and fusion or posterior cervical laminoplasty.   "
231049|NCT00876616|"     The purpose of this study is to assess the efficacy and safety of multi-target therapy in the     treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ lupus nephritis.   "
231050|NCT00876629|"     MR Elastography is a new technique aimed at non-invasively measuring the stiffness of     tissues. It has recently given interesting results in the assessment of liver fibrosis.      The objectives of the current study are:        1. to develop an imaging protocol for MR Elastography of the kidneys;        2. To calculate the stiffness of normal kidneys;        3. To evaluate the variability of the measurements of kidney stiffness by repeating the          procedure twice on the same volunteers.   "
231051|NCT00876642|"     Radiation therapy (RT) has been a component of breast cancer treatment for almost 100 years.     Although initially used for the treatment of chest wall recurrences after mastectomy and for     advanced inoperable disease, RT has evolved into a critical component of early therapy for     women with an intact breast following lumpectomy and for mastectomized women who are at high     risk for local failure. Currently breast cancer patients need a multidisciplinary management     including surgery, chemotherapy and radiotherapy, radiotherapy has a significant role in loco     regional control of the disease. It is estimated that 87% of these women will develop some     degree of radiation-induced dermatitis, varying from mild to brisk erythema or even moist     desquamation.      Topical agents, such as corticosteroid creams and other products including Aquaphor     (Beirsdorf Inc, Wilton, CT), and trolamine (Biafine; Genmedix Ltd, France), are commonly     prescribed at the onset of radiation dermatitis or, in some institutions, at the beginning of     radiotherapy.      The aim of this randomized phase III study was to assess the effectiveness of aloe vera cream     for the prevention of acute radiation-induced dermatitis of grade 2 or higher during     postoperative radiotherapy for breast cancer, compared to best supportive care. The secondary     objectives were to assess pain, treatment interruption as a result of skin reactions, and the     quantity of life during the treatment.   "
231052|NCT00876655|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)     of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium     phosphate salt formulated capsule) after single doses in normal healthy adult subjects and to     assess the relative bioavailability of TR-701 free acid phosphate powder in capsule     formulation compared to di-sodium phosphate salt formulated capsule.   "
231053|NCT00876668|"     The aim of the study is to compare the diagnostic value of this non-invasive vascular imaging     tool with the established vascular diagnostic methods for PAD in order to get prognostic     data.      A higher sensitivity of Fluorescence angiography in order to recognize progression of     critical limb ischemia could lead to earlier therapeutic interventions and thereby increase     limb salvage. A diagnostic gap would be closed.   "
231054|NCT00876681|"     Research study to determine if pain relief following foot and/or ankle surgery is influenced     by the technique used to place perineural catheter. The catheters are placed using     ultrasound-guidance or nerve stimulation and the method is selected at random using a     computer program. This may help to determine if one of these methods is associated with an     increased success rate and incidence of foot numbness during the infusion.   "
231056|NCT00876707|"     The purpose of this study is to determine if differences in the design of multifocal     intra-ocular lenses would mean different values of higher-order aberrations and different     performance in objective parameters such as modulation transfer function.   "
231057|NCT00876720|"     Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by     hearing loss and leading to the phantom auditory perception of sound in the absence of an     external or internal acoustic stimulus.   "
231058|NCT00876733|"     This observational study is supposed to assess (under conditions of clinical practice in     daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g.     Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir     and emtricitabine) will durably suppress viral load below the limit of detection or will     maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under     previous anti-retroviral combination therapy after switch to combination treatment of     Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir     and Lamivudine) or Truvada (tenofovir and emtricitabine).   "
231059|NCT00876746|"     This research study is to determine if the insertion site of a perineural catheter or tiny     tube placed next to the nerves that go to the part of the body (hand or arm) having surgery,     affects the amount of pain relief that is experienced after surgery. Catheters will be placed     in either the supraclavicular or infraclavicular location.   "
231073|NCT00876928|"     Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D     levels will delay the development of diabetes.   "
231074|NCT00876941|"     The objective of this study is to test whether screening and brief intervention for drug use     among primary care patients leads to improved drug-related outcomes (such as decreased drug     use and consequences).   "
231060|NCT00876759|"     Brain metastases occur in 20-40% of patients with primary extracerebral tumors. Despite     important advances in therapy of malignant solid tumors and treatment of 1-3 brain     metastases, multiple brain metastases continue to present a significant problem in attempting     to prevent progression of disease and limit morbidity associated with therapy. The majority     of patients who develop brain metastases have a short survival, effective palliation being     transient. The median survival after diagnosis is as low as 3-6 months. However, there is     some evidence that selected patients survive prolonged periods with vigorous therapeutic     approach.      Specific therapeutic options are surgery, chemotherapy, conventional fractionated whole-brain     radiotherapy (WBRT) and radiosurgery. Radiosurgery allows delivering of a single high dose     fraction of radiation to targets of 3-3.5 cm maximum diameter. In patients with newly     diagnosed brain metastases, a rapid decrease of symptoms, local tumor response rate of 73-90%     and a median survival of 7-12 month have been reported.      WBRT alone is the treatment of choice for patients with multiple brain metastases, and for     patients with single brain metastases not amenable to surgery or radiosurgery. Median     survival after WBRT alone is 3-6 months.      WBRT and radiosurgery boost have been shown to improve survival in RPA class I patients and     in patients with favorable histological status and squamous cell or non-small cell lung     tumors. All randomized trials showed improved local control with the addition of radiosurgery     to WBRT (Andrews, 2004).      WBRT in conjunction with radiosurgery improves local control and reduces the risk of new     distant brain metastases, but most studies support that combined radiosurgery and WBRT does     not improve the overall survival expect for patients without evidence of extracranial     disease.      Helical Tomotherapy (HT) allows as a sole modality a new treatment option: Using HT, the     advantage of applying a highly conformal boost dose to the metastases and WBRT can be     combined in one treatment session. Therefore, it allows applying a high dose to multiple     brain metastases in the sense of an integrated boost. The focus of this study is to     investigate the efficacy and safety of WBRT with an integrated boost using this new treatment     modality in comparison to the effects of conventional WBRT alone.      The principal objective of the trial is to assess the therapeutic efficacy of WBRT as     compared to WBRT combined with integrated boost with HT delivered to patients with 2-10 brain     metastases of solid tumors. The secondary objective is to evaluate the safety of WBRT as     opposed to WBRT combined with integrated boost as delivered by HT in patients with 2-10 brain     metastases.   "
231061|NCT00876772|"     Amyotrophic Lateral Sclerosis (ALS) is an adult neurodegenerative disease that is caused by a     selective degeneration of the motor nerve cells in the cortex and myelon. As a result of     motor neurodegeneration, a progredient paralysis of the extremities and of the speaking,     swallowing, and breathing musculature develops. ALS leads to death by respiratory     insufficiency in a mean course of 3-5 years. More than 80% of ALS patients present with a     clinically significant and undesirable weight loss. The cause of weight loss is     heterogeneous. Fundamentally, the investigators must distinguish malnutrition, cachexia and     loss of appetite. Loss of weight is an independent prognosis factor in ALS. Effective     treatment of undesirable weight loss is an important therapy goal for ALS.      The researchers propose an investigational therapy of ALS with oral administration of     Olanzapine. The rationale for this study is based on the weight-increasing effect of OLN. The     clinical trial aims to employ OLN-induced weight gain or weight stabilization as a     symptomatic therapy for the loss of appetite. An undesired weight loss of at least 10% of the     body weight should be reduced through the weight-increasing effect of OLN. The hypothesis     states that the undesired weight loss in ALS patients during treatment with OLN 10mg in     combination with Riluzole (RIL) 100mg is at least 20 percentage points less than for     treatment with placebo in combination with 100 mg RIL.   "
231062|NCT00876785|"     The aim of the present study was to investigate subjective appetite during 8 hours after     intake of iso-caloric rye bread breakfasts varying in dietary fiber composition and content.   "
231063|NCT00876798|"     The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan     capsules in subjects with Euvolemic Hyponatremia.   "
231064|NCT00876811|"     The purpose of this study is determine whether daily consumption of frozen red raspberries     can improve the antioxidant capacity of the blood and reduce the effects of oxidative stress,     dose-dependently, in a healthy adult population.   "
231065|NCT00876824|"     The purpose of this study is to determine whether a single bolus of dose of Amphoterin B     lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal     Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).   "
231066|NCT00876837|"     The purpose of this study is to assess life satisfaction and long-term outcomes (i.e.,     medical and psychosocial) of adults who sustained spinal cord injuries (SCI) as children or     adolescents.   "
231067|NCT00876850|"     A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of     complicated skin and skin structure infections (cSSSI).   "
231157|NCT00877994|"     Nurture is a collaborative pilot study for mothers of children under the age of 3 who have     suffered from disordered eating in the past. It is coordinated by the University of North     Carolina at Chapel Hill, Duke University and Virginia Commonwealth University and sponsored     by the National Institute of Mental Health. Nurture hopes to promote confident parenting and     a positive meal times.   "
231240|NCT00879281|"     The purpose of this randomized controlled trial is to evaluate the hypothesis that the     'written' action plan, a self-management tool developed by the project group, enhances early     detection and prompt action measures and consequently isbeneficial in exacerbation outcome     (i.e., health status recovery time).   "
231068|NCT00876863|"     The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment     of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells     in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve     Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect     them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has     been carefully studied in laboratory animals and is in the early stages of being tested in     people.      Fifty patients with mild to moderate Alzheimer's disease will participate in this study. Half     of the study subjects will have CERE-110 injected into the brain during a surgical procedure,     while the other half will undergo a placebo surgery where no medication will be injected.     All study participants will be followed for at least two years after surgery.   "
231069|NCT00876876|"     To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is     maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo     during the 4 week double blind treatment period.   "
231070|NCT00876889|"     The purpose of the study is to find out if the use of the drug Riluzole is both safe and     improves outcome in patients with acute traumatic spinal cord injury (SCI).   "
231071|NCT00876902|"     The study is designed to assess the feasibility of evaluating YSPSL for the amelioration of     ischemia reperfusion injury following liver transplantation by administering YSPSL into the     liver graft directly ex vivo via the portal vein and to the recipient intravenously prior to     reperfusion. This study is an extension of the recent pilot study YSPSL-0002 with an almost     identical study protocol. The rationale of this and the previous study is based on the recent     observation that P-selectin expression has been associated in liver grafts with prolonged     cold storage times and rejection. By examining biomarkers of IRI including P-selectin by     immunohistochemistry and/or quantitative PCR, liver histology and hepatic blood flow using     established techniques, the goal of this study is to evaluate the feasibility of using these     modalities for future studies of safety and efficacy.   "
231072|NCT00876915|"     Some cancer patients starting a new chemotherapy regimen are likely to develop blood clots,     also known as venous thromboembolism (VTE). Blood clots can cause symptoms and can     occasionally be life-threatening. The purpose of this study is to determine if a daily     injection of a blood-thinner, dalteparin, for 12 weeks can safely and effectively reduce the     frequency of blood clots. Dalteparin is currently approved for prevention of blood clots     following surgery and in hospitalized patients but not specifically for cancer outpatients.   "
231077|NCT00876980|"     The investigators hypothesize that obstructive sleep apnea (OSA) contributes to impaired     glucose homeostasis and associated vasculopathy, and nCPAP treatment of OSA should improve     glycemic control and vascular function in OSA patients with type II diabetes mellitus. This     study aims to investigate the therapeutic effects of nCPAP on glycemic control and vascular     function in patients with OSA and type II diabetes mellitus.   "
231078|NCT00876993|"     Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity     in a variety of central nervous system tumors. No prospective studies have been published or     are currently in progress within the major consortiums with this combination of drugs. Brain     tumors are the second most common cause of cancer in pediatrics and the leading cause of     cancer death in children. For children with High Grade Gliomas or with relapsed/refractory     brain tumors, new agents in new combinations are needed. Historical data shows that newly     diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant     gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%.     This study is a phase I study designed to provide an objective observation of toxicity and     establish a maximum tolerated dose of this combination. In addition, this study will observe     the response of children with relapsed or refractory central nervous system tumors.   "
231079|NCT00877006|"     The primary objective of the study is to compare the complete response (CR) rate of     bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab,     cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide,     doxorubicin, vincristine, and prednisone (R-CHOP) in patients with advanced, indolent     non-Hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL).   "
231080|NCT00877019|"     Aim:      The study was designed to test the time dependent efficacy in plaque removal of four     toothbrushes: one electric toothbrush, the Philips Sonicare Elite with long (A) and short (B)     brushing head and two manual brushes, the Gaba Sensitve (C), and the ADA reference brush (D)     and.      Materials and Methods:      The study was a single-blind, randomized clinical timer study consisting of four identical     experiments testing each brush in one quadrant. The distribution of the quadrants and brushes     was randomized so that always all brushes were used within one participant. The teeth were     brushed by a dental hygienist for 10, 20, 30, 45, 60 und 90 seconds per quadrant. No     toothpaste was used throughout this study. The plaque assessment (Tureskey modified QHI) was     done after each time interval blinded on six sites per tooth by a separate investigator.     Ninety subjects participated in the study and received a professional prophylaxis prior to     the experiment. They were requested to refrain from brushing their teeth for 48 hours prior     to the experiment.   "
231081|NCT00877032|"     The purpose of this study is to determine the safety and tolerability of RN6G in patients     with dry, age-related macular degeneration.   "
231082|NCT00877045|"     This is a retrospective medical record abstraction to evaluate the patterns of care for     Gastrointestinal stromal tumors (GIST) in the community setting. Patient demographics and     characteristics along with the treatments received will be described. Investigators will     establish the percentage of patients who undergo surgery, the percentage of patients who are     treated with kinase inhibitors as well as in what setting (adjuvant or metastatic) as well as     the duration of therapy. Physician information will also be collected to assess for     differences in treatment based on physician or geographical differences.   "
231199|NCT00878735|"     The purpose of this study is to evaluate the effects of a Zen meditation retreat (Sesshin) on     psychophysiological parameters in healthy volunteers (regular meditators and non-meditators)     and in cancer patients and to observe possible changes in the attentional circuitry (through     functional Magnetic Resonance Imaging- fMRI) and in psychological tests (Beck Anxiety and     Depression Inventories, Self-Compassion Scale, Mindfulness Attention Awareness Scale, Lipp     Stress Scale for Adults).   "
231083|NCT00877058|"     The present study Elderly person in the risk zone form part of the research programme     Support for frail elderly persons - from prevention to palliation (www.     Vardalinstitutet.net) which comprises research into three interventions. A fundamental     principle in the research programme is that it comprises interventions addressing frail     elderly person in different phases of the disablement process, from elderly persons who are     beginning to develop frailty to very frail elderly persons receiving palliative care in the     final period of their lives. The interventions also address the different requirements that     arise with regard to professional contributions during the various phases of the ageing and     disease process, ranging from health promotion to a need for an increasing degree of medical     care, nursing, special care and rehabilitation, and finally, efforts that promote symptom     relief, quality of life, security and satisfaction with care during the final period of life.     The intervention Elderly persons in the risk zone addresses elderly persons that are on the     point of developing frailty (pre-frail) and are beginning to feel that they are being     hindered from taking part in everyday activities. The hypothesis is that if an intervention     is made when the persons are not so frail, it is possible to prevent/delay deterioration.        1. Can a health-promoting and preventive intervention for prefrail elderly persons:             -  prevent frailty, activity limitations and morbidity,             -  be a supportive factor in the social and physical environment,             -  affect life satisfaction             -  have an impact on the consumption of care             -  be cost-effective?        2. How do the frail elderly persons experience the intervention and its importance to          health?   "
231084|NCT00877071|"     Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic     options. Patients who present with HCC beyond the currently accepted Milan criteria are not     eligible to be listed for liver transplantation. The proposed study offers local regional     therapy to a defined population of patients beyond Milan criteria as an attempt to downstage     them to eligibility for liver transplant.   "
231095|NCT00877214|"     The purpose of this study is to determine if an extended maintenance therapy with Rituximab     in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has     advantages compared to a shorter or no maintenance therapy.   "
231096|NCT00877227|"     The purpose of this study is to determine whether supplementation with folinic acid, a B     vitamin, lowers the concentrations of total homocysteine in newborns. Increased homocysteine     concentrations are associated with an increased risk of cerebrovascular accidents in adult,     children and newborns. These increased concentrations can easily and safely be lowered by     folic acid in adults.   "
231097|NCT00877240|"     The goal of this study is to determine the effectiveness of a general intervention that     includes encouragement of physical activity and healthy living habits of officers and     permanent staff in the IDF   "
231098|NCT00877253|"     The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus     Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in     subjects with advanced ovarian cancer.   "
231085|NCT00877084|"     When patients with chronic obstructive lung disease (COPD) are admitted to the hospital with     a severe exacerbation they lose muscle strength. This muscle weakness predisposes these     patients to further hospital admissions. Resistance training is a potent countermeasure to     prevent and treat muscle weakness. In the setting of an acute exacerbation this intervention     however has not been validated.      The present study aims at investigating the safety and efficacy of resistance training (3x8     quadriceps extensions per day) to prevent muscle weakness. End points are quadriceps muscle     strength and hospital readmission and functional status at discharge. Using the minimally     invasive needle muscle biopsy technique described by Bergström the effects of resistance     training on the skeletal muscle will be analyzed in detail.      After giving informed consent, patients will be randomized on admission into usual care or     usual care plus resistance training. Patients will be followed-up using the clinical pathway     for COPD (10 days). After one month patients will attend the outpatient clinic for a     follow-up visit. Besides the measurement prescribed in the clinical path for COPD (including     arterial blood gas measures, lung function, functional investigation of the patients),     patients will undergo muscle strength measures and venous blood will be drawn for the     analysis of systemic inflammatory and growth factors. Half of the patients will receive a     resistance training program. At the end of the hospital admission, a needle biopsy of the     vastus lateralis muscle will be obtained.   "
231086|NCT00877097|"     Recent studies suggest that the combination of two inhibitors of bone resorption may induce a     greater increase in bone mineral density (BMD) than either agent alone.      In this 5-year partly randomized study the investigators examined the effects of hormone     therapy (HT) with or without bisphosphonate on BMD on osteoporotic women.      In the Kuopio Osteoporosis Study (OSTPRE) a population based sample of 3200 women were     selected for BMD measurement by Lunar DPX in 1995-1997. In all 167 women aged 61±2.7 years     (11±4.9 years postmenopausal), and the T-score < -2.5 SD at either the lumbar spine or     femoral neck were recruited for this sub-study.      They received daily estradiol hemihydrate (E2) 2mg + norethisterone acetate (NETA) 1mg     (Kliogest®, Novo Nordisk, Denmark) and were randomized to get additional Boneplac, which     consisted of either 800mg clodronate (Bonefos®, Leiras Ltd, Finland) (n=55, KB-group) or     placebo (n=55, K-group). In case of contraindications or refusal from HT, the women were     offered clodronate 800 mg/day (n=57, B-group) to be taken to empty stomach with a glass of     water 30 minutes to two hours before breakfast.      BMD was measured at time intervals 0, 1, 3 and 5-years. All repeated BMD values were     interviewed by one investigator and primarily the vertebrae L2-L4 were followed. In case of     spinal deformities during the study (38.3%) other lumbar levels were followed. The baseline     BMD values (lumbar spine BMD 0.839±0.072 g/cm², femoral neck BMD 0.759±0.094g/cm²) were     similar between the groups.   "
231087|NCT00877110|"     Funding Source - FDA OOPD FDR004128      The goal of this study is to see if it is safe and feasible to give chemotherapy, natural     killer (NK) cells, and an antibody called 3F8. The NK cells must come from a family member     who shares half of the HLA proteins which are immune proteins important in transplant. NK     cells are a type of white blood cell. They can recognize and kill abnormal cells in the body     and can work together with antibodies to kill target cells. The antibody 3F8 specifically     recognizes a protein present on the target cancer cell.   "
231241|NCT00879294|"     The purpose of this study is to see if chewing gum after surgery for perforated appendicitis     will shorten the time of intestinal dysfunction.   "
231088|NCT00877123|"     Obesity, and its metabolic consequences - impaired fasting glucose (IFG) and diabetes, is     highly prevalent among Arab women in Israel and the Middle East. Since life style     modification is difficult to achieve in this population it is important to assess whether     other modifiable risk factors can be detected. There is evidence that the homeostasis of     vitamin D has a significant role in the eventual development of diabetes. Previous cross     sectional studies have shown that low 25 (OH) vitamin D levels are related to glucose     intolerance, diabetes, insulin resistance and metabolic syndrome. The study hypothesis is     that 25(OH) vitamin D deficiency is highly prevalent among Arab women with IFG and that     vitamin D supplementation may improve IFG and by that reduce the risk for future overt     diabetes. Additionally, obesity is associated with a low-grade inflammation of white adipose     tissue (WAT) resulting from chronic activation of the innate immune system. In obesity, there     is an increased production and secretion of a wide range of inflammatory molecules including     interleukin-10 (IL-10), which may have systemic effects on WAT and other organs. To that end     the investigators will assess the influence of vitamin D supplementation on IL-10 and hs-CRP.   "
231089|NCT00877136|"     This is an interdisciplinary study that falls into the Humanitarian Use Device category.     There are no hypotheses to be tested in this treatment protocol. The study has the following     objectives:        1. Provide supervised access to treatment with TheraSphere® to eligible patients with          primary cancer to the liver who are not surgical resection candidates.        2. Evaluate patient experience and toxicities associated with TheraSphere® treatment.        3. Measure tumor response rates   "
231090|NCT00877149|"     The purpose of this trial is to provide data of absence of inflammation in patient liver     histology after long-term telbivudine treatment and thus help investigators to make a     comprehensive judgment on treatment discontinuation in selected patients   "
231091|NCT00877162|"     Night waking with crying can be a distressing and difficult experience for infants and their     parents. The investigators want to reduce infant night waking and crying and improve parents'     views of their infants' sleep. This study will help the investigators determine whether     parents who receive group teaching about infant sleep and follow-up phone calls provided by     Public Health Nurses will reduce numbers of infants' night wakes and parents' perceptions of     infant sleep difficulties compared with parents who receive a group teaching about infant     safety and follow-up phone calls provided by Public Health Nurses. Results from this study     will help the investigators improve their practice when assisting parents and infants with     sleep problems.   "
231092|NCT00877175|"     The purpose of this study is to compare the mydriatic effect of 2.5% phenylephrine and 1%     tropicamide by conventional instillation and lower conjunctival fornix packing in premature     infants.   "
231093|NCT00877188|"     The purpose of this study is to evaluate the effects of a combined aerobic and resistance     exercise program in breast cancer survivors.   "
231094|NCT00877201|"     The purpose of this study is to determine the antioxidant supplementation effect on     accommodation among visual display terminal (VDT) users.   "
231099|NCT00877266|"     This research study is to determine the relative times for perineural catheter placement with     the use of ultrasound versus electrical stimulation. The perineural catheter is placed next     to the nerves through which local anesthetic is placed to provide pain control following     surgery. This study may determine if one method is associated with increased success rate and     patient comfort.   "
231100|NCT00877279|"     This study is to determine the safety and effectiveness of Belotero® Soft compared to active     comparator in the correction of mild facial wrinkles, such as nasolabial folds.   "
231101|NCT00877292|"     The study will examine the sensitivity and specificity of a circulating cell-free nucleic     acid test (DNA/RNA) to identify Down syndrome between about 10 weeks and 21 weeks 6 days     gestation. In addition, the new test may be used to identify trisomy 13 and 18 as part of a     more complete laboratory developed test. We hypothesize that the new circulating cell-free     fetal NA-based test will accurately and precisely measure specific fetal markers in maternal     circulation and that measurement will lead to the ability to noninvasively identify with high     sensitivity and specificity, fetal chromosome abnormalities, such as Down syndrome.   "
231102|NCT00877305|"     The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on     cognitive function in patients undergoing cardiac surgery compared to control intervention.   "
231103|NCT00877318|"     The purpose of the READ study is to compare the continuation of the cardiac rehabilitation at     home with clinical follow-up, therapeutic education, and advice on the training at the     stamina, via telemedicine with the classic strategy in day hospital.   "
231104|NCT00877331|"     This study will examine the effectiveness of a brief intervention in a primary care setting     to reduce drug use or abuse compared to enhanced care as usual.   "
231105|NCT00877344|"     Hypothesis      Intrauterine contraception placed immediately after a second trimester abortion will result     in fewer pregnancies than current standard practice of intended placement at 4 weeks     post-abortion.      Study Design      Randomized Controlled Trial after their second trimester abortion comparing immediate with     delayed insertion of IUC, and a non intervention control group choosing non-intrauterine     contraception. Participants choosing an IUC will be randomly assigned to immediate or delayed     insertion. The investigators primary outcome is pregnancy rate within one year.   "
231106|NCT00877357|"     A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the     safety, immunogenicity (short term and long term) and clinical consistency of three     production lots of the vaccine.   "
231107|NCT00877370|"     Critically ill patients in the intensive care unit often receive continuous hemodialysis to     treat their kidney failure. Ertapenem is an antibiotic often used in these patients.     Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate     treatment of their infection. This study will determine how much ertapenem is removed by     continuous hemodialysis.   "
231108|NCT00877383|"     This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when     combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients     with chronic obstructive pulmonary disease (COPD).   "
231633|NCT00885313|"     The purpose of this interventional study is to evaluate the efficacy and tolerability of     docosahexaenoic acid (DHA) in children or adolescents with well-characterized and liver     biopsy confirmed nonalcoholic fatty liver disease (NAFLD).   "
231109|NCT00877396|"     The goal of this randomized clinical trial is to determine whether immunizing children in     Hutterite colonies with inactivated influenza vaccine can prevent influenza and its     complications in other colony members. Furthermore, the study will assess the indirect     benefit to Hutterites at high risk of complications. The study is a blinded, cluster     randomized controlled trial among Hutterite colonies to test the hypothesis that high     immunization rates (>70%) of healthy children with inactivated influenza vaccine reduces     transmission of influenza to other colony members. Randomization of these homogeneous,     moderately sized colonies where there is regular spread facilitated by a communal lifestyle,     but limited re-introduction because of relative isolation from outside community, represents     a unique opportunity to test the hypothesis of indirect benefit under close to ideal     conditions. The primary outcome will be laboratory-confirmed influenza. Secondary outcomes     include influenza-like illness, otitis media, physician visits, antimicrobial prescriptions,     absenteeism, lower respiratory tract infection, hospitalizations, and death.   "
231110|NCT00877409|"     The objective of this study is to establish the safety in use of the topical drug Acnase     Creme and its effectiveness in treatment of acne grade I (comedones) and II (comedones,     papules, pustules).   "
231111|NCT00877422|"     Pneumonia is the fourth leading cause of death and frequently occurs in institutionalized     elderly people in Japan. Recently, several clinical and experimental studies have reported     the importance of vitamin D in the regulation of immune functions and its deficiency is     associated with susceptibility to some infections. In the present study, the investigators     hypothesize that deficiency of serum vitamin D is associated with development of pneumonia,     and supplementation of vitamin D may lower the incidence of pneumonia and prolong survival in     institutionalized elderly subjects.   "
231112|NCT00877435|"     The purpose of this study is to determine whether prize-based contingency management     (prizeCM) combined with cognitive behavioral therapy (CBT) is more effective in the treatment     of of cocaine-dependent patients compared to CBT only. Patients were randomized to prizeCM +     CBT (experimental group) or to CBT (control group) an treated over 24 weeks. It is the first     trial of this type in Europe.   "
231113|NCT00877448|"     A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety     study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy     volunteers.   "
231114|NCT00877461|"     According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of     fingertips and vein as samples to evaluate the accuracy of portable BGM.   "
231115|NCT00877474|"     This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic     study of PM01183 for patients with advanced solid tumors   "
231116|NCT00877487|"     The primary objective of this study is to evaluate the maintenance of efficacy, as measured     by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global     Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects     with ADHD have been on stable treatment with commercial SPD489 for a minimum of 6 months and     are maintained on their screening dose of commercial SPD489.   "
231117|NCT00877500|"     The goal of this clinical research study is to learn about certain genes and proteins in     tumors that do not respond well to treatment. These features will be compared with the status     of the disease after surgery for breast cancer that does not express the HER2 protein, when     patients either receive or do not receive ixabepilone. The safety of ixabepilone in this     group of patients will also be studied.   "
231118|NCT00877513|"     Cigarette smoking increases CVD risk and worsens insulin resistance, but also contributes to     weight loss; smoking cessation reduces CVD risk and improves insulin sensitivity, but also     contributes to weight gain. The mechanisms that underlie these metabolic changes of cigarette     smoking and smoking cessation on insulin resistance, body composition, and fat distribution     are poorly understood.   "
231119|NCT00877526|"     This study is conducted in Asia. The aim of this observational study is to evaluate current     status of diabetes management, control, and complications in diabetic subjects in Asia.   "
231120|NCT00877539|"     PF-03526299, a novel anti-inflammatory agent should attenuate the effect of a bronchial     allergen challenge on lung function and hence provide proof of mechanism for this agent.   "
231121|NCT00877552|"     The purpose of this study is to use structural and functional magnetic resonance imaging     (MRI) to study children at high risk for schizophrenia. It is hypothesized that children at     high risk for schizophrenia will have abnormalities of brain development, especially of the     cerebral cortex. The study will also describe normal brain development in children from birth     to age 6 years   "
231122|NCT00877565|"     Systolic function is a substantial determinant of overall hemodynamics and organ function.      Therefore assessment of left ventricular systolic function (LVF) has been of central interest     in Echocardiography. Ejection fraction (EF) measurement has been the gold standard     echo-derived measure to describe LVF. However, EF is a blood pool derived and therefore load     dependent measure.      Global longitudinal peak systolic strain average is a new parameter derived from speckle     tracking tachnique. As a primarily myocardial deformation parameter it is considered to be an     equivalent to EF measurement, but maybe less load dependend. The aim of the study is to     investigate the reliability of GLPSS average to quantify LVF in the perioperative setting (in     cardiac and non-cardiac cases).   "
231123|NCT00877578|"     The aim of this study is to evaluate in malnourished elderly patients the nutritional     efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients     (leucine, micronutrients, omega-3) appearing in the form of a cake of high caloric density     and palatability.      The primary endpoint is the outcome of fat-free mass measured by multiple frequence     bio-impedance analysis.   "
231179|NCT00878462|"     This trial was a randomized trial to determine a patient's acceptability of unflavored     antipsychotic medication compared to raspberry flavored antipsychotic medication. Patients     received 6 total doses of study drug (2 doses of each asenapine formulation) over 3     consecutive days: 2 different formulations each day, 1 in the morning and 1 in the evening.     The formulations were: white unflavored, white raspberry flavored, and red raspberry     flavored. Patients were given a questionnaire following each dose of study medication (one     questionnaire twice per day for 3 days) to measure how acceptable each formulation was.   "
231124|NCT00877591|"     The purpose of this study is to examine the interactions of buprenorphine-naloxone, a     medication used to treat opiate (heroin or prescription narcotic) dependence, and medications     used in the treatment of HIV disease including atazanavir (Reyataz), fosamprenavir (Lexiva),     didanosine (Videx), tenofovir (Viread), atazanavir (Reyataz)/ritonavir (Norvir),     fosamprenavir (Lexiva)/ritonavir (Norvir), lamivudine (Epivir), or darunavir (please note     that we have completed drug interaction studies for buprenorphine with atazanavir,     atazanavir/ritonavir, didanosine, tenofovir and lamivudine) at the PI's previous university;     for this CHR application only the studies needed to be completed at UCSF/SFGH will be     discussed) or tuberculosis(TB) (rifampin or rifabutin) medications (note: supplement     application currently pending). Participants are those with opioid dependence who qualify for     buprenorphine/naloxone treatment or they are healthy subjects without opioid dependence who     participate in pharmacokinetics studies of the antiretroviral medications. A total of 160     such individuals will be enrolled in these studies (please note that the studies have been     ongoing at Virginia Commonwealth University for 3 years so that the total number of     participants to be recruited at UCSF/SFGH will be about 50 protocol completers). Participants     take the HIV or tuberculosis medicine(s) for up to 15 days (depending on the medication(s)     administered and ability to schedule blood and urine sampling sessions).   "
231125|NCT00877604|"     The preclinical rationale for tauroursodeoxycholic acid (TUDCA) use in treating patients with     amyotrophic lateral sclerosis (ALS) stems from the demonstration of antioxidant,     antiapoptotic and neuroprotective properties of TUDCA in the central nervous system (CNS),     both in vitro and in vivo models.      This protocol is meant for assessing if the addition of TUDCA to the conventional therapy can     improve the therapeutic outcome in patients affected by ALS.      Safety will be assessed for all subjects, for the entire duration of the study. 30 patients     affected by ALS with site of onset in the limbs will be recruited.      All enrolled subjects will continue receiving riluzole at the same regimen as before entering     the trial. Based on an appropriate random code, subjects will be divided into two groups of     equal size treated, after a lead-in period of 3 months, by oral route with TUDCA at the dose     2 g daily for 1 year or with identical placebo by oral route at the same dosing schedule,     under double-blind conditions.      Every concomitant and/or supportive therapy will be admitted.      Evaluation criteria:      Efficacy. The proportion of responder patients in the two treatment groups was the primary     outcome measure of the study. Responder patients were defined as those subjects showing an     improvement of at least 15% in the ALSFRS-R (2) slope during the treatment period as compared     to the lead-in period. This threshold was chosen based according to the consensus conference     on designing and implementing clinical trials in ALS (3).      Other parameters will include ALSFRS-R at study end, FVC%, the SF-36 quality of life rating     scale, time to tracheotomy from starting of study medication dosing (if appropriate),     survival Time from starting of study medication dosing (if appropriate), Medical Research     Council scores for right and left muscle groups.      Safety. Incidence, severity and type of adverse events; changes in clinical laboratory     findings.   "
231126|NCT00877617|"     Primary Objectives:        1. To describe patient quality of life (QOL) related to bladder, bowel, and sexual          function, as well as mental and physical health, in patients who received neoadjuvant          investigational therapies prior to radical prostatectomy (RP) for high risk clinically          localized prostate cancer (HRCLPC).        2. To identify medical and demographic variables that are related with quality of life,          e.g., hormonal or non-hormonal neoadjuvant treatment, time since surgery, disease          recurrence, subsequent treatment, age, ethnicity, and socioeconomic status.      Secondary Objectives:      1. To describe treatment satisfaction expressed by patients who have received neoadjuvant     investigational therapies prior to radical prostatectomy for high risk clinically localized     prostate cancer.   "
231127|NCT00877630|"     The investigators had performed more than 250 cases of breast approach endoscopic     thyroidectomy (BAET). The goal of this study is to evaluate whether BAET could be a minimally     invasive procedure under the expert's hands.   "
231219|NCT00879008|"     In this study data of patients with moderate or severe acute exacerbations of chronic     bronchitis (AECB) were collected. There were two different cohorts which were compared     (Moxifloxacin and other antibiotics) concerning effectiveness and tolerance. It was a     prospective study which was accomplished in 100 ambulatory practice offices.   "
231128|NCT00877643|"     The purpose of this study is to investigate whether in patients with early persistent atrial     fibrillation and mild to moderate early heart failure an aggressive upstream rhythm control     approach, including aldosterone receptor antagonists and statins, dietary restrictions,     counseling and cardiac rehabilitation programs, increases persistence of sinus rhythm     compared with conventional rhythm control after one year of follow-up.      A randomized long term extension of the RACE 3 will be performed with a total follow-up of 5     years to investigate the long term effects on persistence of sinus rhythm and cardiovascular     morbidity and mortality of the two treatment strategies.   "
231129|NCT00877656|"     The purpose of this study is to assess the safety and efficacy of treatment of non-cutaneous     T-cell lymphoma with treatment with CD4.   "
231130|NCT00877669|"     The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser     Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the     Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).   "
231131|NCT00877682|"     The goal of this clinical research study is to learn if using cryotherapy to treat only the     part of the prostate that contains cancer is an effective treatment for prostate cancer. The     safety of this treatment will also be studied. Researchers also want to learn if treating     only the part of the prostate with cancer causes less impact on your quality of life than     other types of therapies.   "
231132|NCT00877695|"     The purpose of this study is to develop and pilot test a culturally and developmentally     tailored Motivational Enhancement Intervention (MEI) to reduce risky sex (unprotected anal     sex and multiple partners) among young Hispanic men who have sex with men (YHMSM).   "
231133|NCT00877708|"     The purpose of this study is to review patients with E. coli infections at UPMC from     September 1, 2008 to August 31, 2010 to determine if these infections have arisen in the     community rather than in hospitals or nursing homes and determine their clinical outcomes.      The specific aims of this study are to:        1. Review whether cephalosporin-resistant E. coli infections are hospital-acquired,          healthcare-associated or community-associated.        2. Determine the clinical outcome of the patients according to the antibiotics given.   "
231196|NCT00878696|"     Transcranial magnetic stimulation (TMS) is already broadly used in different areas of     neuroscience research. Last year, special attention was drawn to TMS in tinnitus. The aim of     the researchers' study is to investigate the stimulation characteristics of TMS in tinnitus     patients, in particularly the effect of tonic and burst stimulation of the superior temporal     lobe.   "
231134|NCT00877721|"     Experimental design overview:      The proposed project is a prospective experimental study design. Independent old adults (age     65 years old and older) who suffer from minor balance problems willing to participate in the     study will be tested with well-established measuring techniques of balance and gait before     and 4 weeks after balance training program using the Self Mobility Improvement in the     Elderly by Counteracting Falls system (SMILING system). The study design is randomized     clinical trial (RCT), cross over, single blinded study design where 30 subjects will randomly     be allocated into experimental or control groups that will switch groups after 4 weeks of     intervention.      Random sequence generation will be performed by a staff member who will not interact with     subjects during the balance-testing sessions. Subjects will be informed that they are to be     randomly assigned to one of the two groups, both receiving gait training program.      The staff member who administers the training programs will be the only member of the     research team aware of the subjects' group allocations.      A 'blinded' research assistant will administer the balance tests and will perform any data     processing that involves subjective judgments.      Scripts will be used during testing to ensure that all subjects receive the same     instructions.      Testing session between two training periods (T1) will take one week.   "
231135|NCT00877734|"     This is a study of the efficacy and safety of baclofen for alcohol dependence. 80 outpatient     subjects with DSM-IV alcohol dependence will be randomized to 10 mg three times a day (tid)     baclofen or tid placebo. An effort will be made to recruit 40 men and 40 women. Subjects will     receive BRENDA counseling over the 12 weeks of the trial. The Timeline Followback (TLFB)     method will be used to assess drinking patterns. The primary outcome is % heavy drinking     during the trial.   "
231136|NCT00877747|"     Early interim-PET after two courses of chemotherapy is a powerful outcome predictor in     advanced-stage Hodgkin Lymphoma (HL) patients treated with adriamycin (doxorubicin),     bleomycin, vinblastine and dacarbazine (ABVD). Two-year Progression Free Survival of PET-2     positive patients is only 12%, but the optimal treatment for this patient subset is still     unknown.      From January 2006 GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) suggested an early     intensification of chemotherapy with BEACOPP [Bleomycin, Etoposide, Adriamycin (doxorubicin),     Cyclophosphamide, Oncovin (vincristine), Procarbazine, and Prednisone](4 escalated + 4     baseline cycles) for all the HL patients with a positive PET-2 after 2 ABVD courses. The     investigators retrospectively recorded and analyzed these data in order to evaluate if this     strategy could be of benefit for this subset of patients.   "
231137|NCT00877760|"     The purpose of this study is to investigate whether it is possible to augment the response of     patients with HBeAg-positive chronic hepatitis B to entecavir by using a temporary     peginterferon alpha-2a add-on strategy   "
231138|NCT00877773|"     The goal of this clinical research study is to learn if temsirolimus can help to control     advanced cancer in patients who also have a PI3K mutation and/or PTEN loss. The safety of     this drug will also be tested.   "
231139|NCT00877786|"     Cognitive Behavioral Therapy for Bulimia Nervosa (CBT4BN) is a research program funded by the     National Institute of Mental Health and conducted by the UNC Eating Disorders Program and the     University of Pittsburgh Medical Center. Cognitive Behavioral Therapy (CBT) is an     evidence-based treatment and the gold-standard for treating bulimia nervosa. The current     study aims to compare two forms of CBT: face-to-face group therapy and online group therapy     via cbt4bn.org.   "
231140|NCT00877799|"     The purpose of this study is to determine the effectiveness and safety of single intravenous     doses of the kappa opioid agonist CR845 in relieving pain in patients following     laparoscopic-assisted hysterectomy surgery. The study protocol was divided into two parts     with subjects either dosed with study drug the day following surgery (Cohort 1), or     immediately after surgery (Cohort 2).   "
231218|NCT00878995|"     RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in     patients with cachexia caused by cancer.      PURPOSE: This randomized phase I trial is studying whether testosterone administered during     standard of care chemotherapy and/or radiation works by helping patients with squamous cell     carcinoma to maintain their body weight and muscle size and strength during treatment.   "
231141|NCT00877812|"     Marginal vitamin B6 deficiency, which occurs commonly worldwide, leads to a cellular     deficiency of the coenzyme pyridoxal phosphate (PLP). PLP is a coenzyme in several phases of     one carbon (1C) metabolism, which is the array of reactions in which one carbon units are     acquired and used in reactions including nucleotide synthesis, regeneration of methionine     (Met) from homocysteine (Hcy), and methylation of many biological compounds. 1C metabolism is     linked to the transsulfuration pathway in which Hcy undergoes PLP-dependent catabolism     leading to cysteine, whose availability governs the formation of the antioxidant glutathione.     Nutritional or genetic conditions that impair 1C metabolism are associated with elevation in     plasma Hcy concentration and increased risk of vascular disease. It is believed that the     metabolic effects of vitamin B6 deficiency will be most pronounced following protein intake     when the vitamin B6-dependent pathways of amino acid metabolism experience the greatest     substrate load. The human subjects protocols of this study consist of two distinct phases     intended to extend our understanding of basic human 1C metabolism and the effects of marginal     vitamin B6 deficiency under postprandial conditions. Phase 1 will investigate the effects of     vitamin B6 nutrition on the PLP-dependent generation of 1C units by the glycine cleavage     system and on the synthesis of glutathione. Phase 2 will investigate the dependence of     methionine metabolism on vitamin B6 nutritional status, with particular emphasis on the     recycling of Hcy to Met. Each phase of this study will involve 14 healthy, nutritionally     adequate, young adults (7 male, 7 female) who will undergo metabolite profiling and kinetic     analysis using intravenously infused stable isotopic tracers performed both before and after     a ~4-week period of dietary vitamin B6 restriction. Subjects will be assigned to either Phase     1 or Phase 2, which will be identical in design except for the tracers and analytical methods     used. We hypothesize that vitamin B6 deficiency will yield reduction in postprandial rates of     homocysteine remethylation, generation of 1C units from glycine, and synthesis of     glutathione. The results of this study will aid in assessing the consequences of nutritional     and genetic variables affecting human metabolism and will further our understanding of the     relationships between vitamin B6 nutrition and disease.   "
231142|NCT00877825|"     Isoflavonoids, through their estrogen-like activity, are in part responsible for the     cholesterol lowering properties of soy foods. If this is found to be so, then it would be     advantageous not only to promote soy consumption, but also to identify and use soy cultivars     with high isoflavonoid content in production of soy food products. These foods may have a use     in the reduction of serum cholesterol and if they effectively increase the phytoestrogen     activity of soy, may have a role in the prevention of other hormone dependent diseases (e.g.     osteoporosis, certain cancers) in the same way as natural estrogens.   "
231143|NCT00877838|"     The following study is being conducted to explore the safety and effectiveness of a new     chemical entity called NXN-188 in subjects with a history of migraine with aura. In this     study subjects will treat two attacks of migraine with aura during the aura phase - once with     placebo and once with NXN-188.   "
231144|NCT00877851|"     Managing diet and physical activity are vital aspects of diabetes self−care; however, people     with diabetes often find it difficult to make changes to their usual diet and physical     activity patterns. There is some evidence that computer based education may help some people     develop the skills they need to better manage their diabetes. The investigators have     developed an interactive CD−ROM, focusing on knowledge, self−monitoring, goal setting and     skill−development in relation to diet and physical activity for people with Type 2 diabetes.     A major emphasis was placed on eliciting the views of people with Type 2 diabetes throughout     the development of the CD−ROM. This study will examine whether this CD−ROM can improve     knowledge, skills and self−care behaviour in people with diabetes. One hundred participants     who have been diagnosed with Type 2 diabetes in the past 2 years will be assigned by chance     to one of two groups: they will either be assigned to continue with their normal care routine     consulting with their doctor as normal, or they will be assigned to use the CD−ROM at least     once a week for 12 weeks.   "
231145|NCT00877864|"     The objective of this study is to determine the effects of supervised combined aerobic and     resistance training, and the effects of stage-matched written materials delivered by mail or     internet, alone or in combination, on glycemic control as reflected in A1C (glycated     hemoglobin).   "
231146|NCT00877877|"     Infection with human papillomavirus (HPV) has been clearly established as the necessary cause     of cervical cancer. This study is designed to evaluate the long-term immunogenicity and     safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV     vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals     with objectives & outcome measures of the extension phase from Month 60 to Month 120. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month     48 are presented in a separate protocol posting (NCT00316706).   "
231147|NCT00872196|"     This is a follow-up study with no treatment and only samples being collected.   "
231148|NCT00872209|"     The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel     medication developed to treat Acute Diffuse Otitis Externa of bacterial origin.      The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.   "
231149|NCT00872222|"     The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a     ceramic-on-ceramic bearing combination in the treatment of patients with hip joint disease     requiring a total hip replacement. Patients who enter the study will be evaluated at regular     intervals following hip surgery using patient, clinical and x-ray assessments.   "
231150|NCT00877890|"     This study will compare the effects of commercially manufactured exenatide once weekly and     exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or     with oral antidiabetic medications. The study will examine glycemic control (as measured by     HbA1C), safety, and tolerability.   "
231152|NCT00877929|"     To demonstrate that the fixed dose combination of telmisartan and amlodipine is more     effective in lowering blood pressure.   "
231189|NCT00878605|"     The purpose of this clinical trial is to test the effectiveness and safety of a new     anti-diabetes drug (Cyclo-Z) for the prevention and treatment of Type 2 diabetes. This study     will determine dose-dependent efficacy and safety of this new drug for the treatment of human     diabetes. The Food and Drug Administration has granted approval for the use of this     investigational product to be used in a study [FDA approval (Investigational New Drug) IND #:     61,897]. This new drug is thought to work by increasing the amount of zinc in your body,     which in turn should improve your sugar metabolism. If this study successfully proves that     Cyclo-Z is effective for the treatment of diabetes and is without significant side effects, a     large, multi-center study of diabetic patients will then be performed.   "
231190|NCT00878618|"     The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the     oral doses of the extended-release test- and reference formulations of AZD0837 in healthy     volunteers both in fasting and fed conditions.   "
231153|NCT00877942|"     Relative risk for many psychiatric disorders differs dramatically in males and females.     Early-onset disorders, such as autism, occur more often in males; other conditions, such as     schizophrenia, occur at similar rates in males and females, but the sexes differ in     expression. It has been hypothesized that the prevalence and expression of these disorders is     related to sex differences in brain development. X-chromosome effects and early exposure to     gonadal hormones are strong candidates for a causal role. The aims of the research are (1) to     characterize sex differences in brain development from birth to age 2; (2) to test whether     brain development is altered in infants with Turner syndrome, a well-defined genetic disorder     resulting from the partial or complete loss of one of the sex chromosomes. To address aim 1,     high resolution MRI, including diffusion tensor imaging (DTI), will be used to characterize     sex differences in brain development from birth to age 2 in a longitudinal cohort of 250     children. To address aim 2, high resolution MRI, including DTI, will be used to compare brain     development in 70 infants with Turner syndrome (X monosomy) to matched controls from aim 1.     The investigators hypothesize that sex differences in gray and white matter development and     in white matter maturation as assessed by DTI will be present during the first 2 years of     life and that children with TS will exhibit abnormal gray and white matter development in the     neonatal period.   "
231154|NCT00877955|"     This study tests the assumption that the bioavailability of alprazolam from a new sublingual     formulation is the same as that from sublingual formulation expected to be used commercially     in Brazil.   "
231155|NCT00877968|"     The objective of this study was to determine if whole yellow pea flour reduces post-prandial     glycemic responses of novel food products. The second objective was to determine if whole     yellow pea flour produces food products with favorable sensory characteristics including     appearance, taste, smell, texture and overall acceptability, compared to corresponding food     products made with whole wheat flour.   "
231156|NCT00877981|"     The aim of the present study was to compare open minimal-invasive parathyroid surgery with     video-assisted parathyroidectomy in primary hyperparathyroidism (PHPT) patients with a     positive sestamibi scan in a multicentre randomized trial in order to evaluate if     videoassisted surgery gave less postoperative pain and if there was a difference in operating     time.   "
231158|NCT00878007|"     While malaria represents one of the main health problems afflicting schoolchildren, the     evidence base for policy development and programme implementation for school-based malaria     control remains inadequate. A recent study in western Kenya showed that delivering     intermittent preventive treatment (IPT) to schoolchildren improved rates of anaemia and     classroom concentration, but did not improve school performance. This study aims to (i)     investigate the impact of malaria prevention using a strategy of periodic screening using     malaria rapid diagnostic tests and treatment positives using artemether-lumefantrine (AL) on     health and education among schoolchildren and (ii) determine the interaction between health     and improved literacy instruction. The study hypothesis is that that school-based malaria     prevention will reduce rates of anaemia or improve educational outcomes in Kenyan     schoolchildren, when compared to comparison schools. In addition, a programme of training for     primary school teachers to improve literacy instruction will improve literacy rates and there     will be no interaction between the malaria intervention and the education intervention, such     that learning will not be improved when teaching is effective and children are healthy. The     study will be undertaken in 101 randomly selected primary schools in Kwale District. The     malaria intervention consists of screening all children using rapid diagnostic tests (RDTs)     for malaria. Children (with or without clinical malaria symptoms) found to be RDT-positive     will be treated with AL according to national guidelines. Screening and treatment will be     administered by district public health staff once a school term, observed by the evaluation     research team. This intervention has been changed from IPT due to the withdrawal of     amodiaquine in Kenya. The education intervention includes a programme of training for primary     school teachers to improve literacy instruction. The study is designed to detect a 25%     reduction in anaemia and an improvement of 0.2 standard deviations in mathematics and     literacy tests. Additional outcomes will also be measured including malaria parasitaemia,     classroom attention and school attendance. Cost-effectiveness and community acceptability of     the interventions will be assessed. Anaemia and educational outcomes will be assessed before     interventions and 12 and 24 months later. Malaria parasitaemia using blood slides will only     be assessed at follow-up.   "
231159|NCT00878020|"     The purpose of this study is to evaluate the safety profile, tolerability, and     pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of     BMS-819881) in healthy subjects   "
231160|NCT00878033|"     This study investigates the relationship between autonomic dysfunction and chronic     inflammation in hemodialysis patients.   "
231161|NCT00878046|"     The purpose of this study is to determine if the Silent™ hip is effective in the treatment of     patients with hip joint disease requiring a total hip replacement. Patients who enter the     study will be evaluated at regular intervals following hip surgery using patient, clinical     and x-ray assessments. A subset of patients will undergo scans to allow the bone mineral     density of the bone surrounding the implant to be monitored   "
231162|NCT00878059|"     This is a research study about how family members make research participation decisions for a     relative with Alzheimer's or a related dementia. The purpose of this study is to learn more     about how proxies (the family member who makes decisions for that relative), would think     through decisions about whether to enroll their relative in studies for not-yet-approved     medications for Alzheimer's Disease. The long-term goal of the study is to improve the way     researchers inform families about clinical research studies and opportunities for     participation. This study is being sponsored by the National Institute on Aging.      Study participants will be interviewed by a research staff member about research enrollment     decisions for their relative. A number of standardized questionnaires will be administered.     There is only one visit required. The interview lasts about three hours. The investigators     will try to make it as convenient as possible for your schedule.      This is a non-intervention study. UCSF CHR # H58055-31168-02 v.1 Date: 012709   "
231163|NCT00878072|"     This study will assess the safety, tolerability of a single 1500 mg dose of famciclovir in 50     adolescents with recurrent herpes labialis. Eight of the 50 adolescents will also participate     in the pharmacokinetics (PK) assessment of famciclovir single 1500 mg dose   "
231164|NCT00878085|"     The investigators will study motor recovery after robot-assisted therapy after stroke. A     small clinical trial will be conducted to quantify the central nervous system changes     associated with robotic or standard training, and identify trends across high and low     responders in terms of patterns of change in cortical activity and type of white matter     connectivity.The investigators hypothesize that robot training will lead to larger     improvements as compared to standard occupational therapy. The investigators hypothesize that     high responders to the robot training will have reduced compensatory activation in the     bilateral area and will connectivity in the motor tracts.   "
231165|NCT00878098|"     Background:        -  In some countries, such as South Africa, the pesticide DDT is an important chemical for          control of malaria-carrying mosquitoes. However, there is little evidence about the          effects that it might have on human health.        -  DDT has been associated with miscarriage and fetal loss in areas with high levels of          exposure, but more research is needed to determine what levels of exposure are          associated with loss of pregnancies.      Objectives:        -  To examine the relationship between pre-pregnancy levels of DDT in the blood and the          loss of clinically recognized pregnancies.        -  To conduct a pilot study to evaluate data collection procedures for future research.      Eligibility:        -  Women between 20 and 30 years of age who are not currently pregnant and who reside in          villages in the Vhembe District in the northeastern part of South Africa.      Design:        -  Evaluation of eligibility:             1. Short physical examination, with questionnaire about medical history, current               living conditions, and daily life.             2. Several blood samples will be taken for study and to test for anemia, elevated lead               levels, malaria, syphilis, and human immunodeficiency virus (HIV).        -  Half of the women will come from villages that are currently being sprayed with DDT, and          half will come from villages that are not being sprayed.        -  Evaluation before and during pregnancy for subjects who become pregnant:             1. Blood and urine test, including urine pregnancy test.             2. Questions about recent menstrual history and sexual activity.             3. Questions about medical history, including treatment for malaria.        -  Pregnancy follow-up study, including blood draws, will be conducted regardless of          whether the pregnancy is carried to term.        -  Researchers will assess and adjust study parameters as needed.   "
231166|NCT00878111|"     The main objective of the trial is to document the safety and antivascular effect of     escalating doses of NGR-hTNF, from 60 mcg/sqm to 325 mcg/sqm, in patients affected by     advanced or metastatic solid tumors not amenable of standard therapies.      Safety will be established by clinical and laboratory assessment according to NCI-CTCAE     criteria (version 4.02).   "
231167|NCT00878124|"     As women age the ovarian response and pregnancy rate are reduced while the rate of     chromosomal abnormalities in the embryos is increased. Oocyte maturation, accurate     chromosomal segregation as well as early embryo development and implantation are dependent on     the supply of large amounts of energy, which unlike other cells can only arise from the     mitochondria. With age the mitochondria becomes less efficient due to damage to its unique     DNA, resulting in decreased energy production. The proposed study will examine the effect of     the combination of a dietary supplement, Co enzyme Q10 on pregnancy rate and response of the     ovaries to a medication that stimulates follicle growth. The investigators hypothesize that     the improved energetic state of the oocyte would result in a more accurate chromosomal     separation, increased embryo quality and pregnancy rate.   "
231197|NCT00878709|"     The purpose of this study is to investigate whether neratinib can further reduce the risk of     recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment     with trastuzumab.   "
231198|NCT00878722|"     An open-label, non-randomized, multi-centre, Phase I/II trial to assess the efficacy and     safety of 2 schedules of PXD101 in combination with idarubicin in patients with AML not     suitable for standard intensive therapy.   "
231168|NCT00878137|"     The antiphospholipid-antibody syndrome (APLA), which includes lupus anticoagulant,     anticardiolipin, and anti-beta-2-glycoproteinI antibodies, is a thrombophilic disorder     associated with arterial thrombosis, venous thrombosis or both. Patients diagnosed with APLA     have a higher risk of recurrent thrombosis than do patients without known antibodies.     Currently, warfarin is considered the anticoagulant of choice for prophylactic antithrombotic     treatment for APLA patients after their first episode of thrombosis. In some patients with     APLA who are treated with warfarin, the INR values determined on plasma are unreliable due to     an influence of the APLA on the INR. In these individuals, alternative monitoring methods,     such as factor II activity, chromogenic factor X activity or prothrombin-proconvertin time     should be used to assess adequate anticoagulation. These tests are expensive and not widely     available to some clinicians. Point-of-care (POC) instruments, on the other hand, are readily     accessible to clinicians. Previous research has shown that INR values from 3 older     point-of-care (POC) instruments are unreliable in 1/3 of APLA patients (CoaguChekTM,     ProTimeTM, INRatioTM). However, there are now newer versions of these POC instruments     available (CoaguChek XSTM, an investigational ProTime device, and a newer INRatioTM device)     and it is unknown if these newer POC instruments are reliable in patients with APLA. The     purpose of this study is to determine whether newer POC instruments are reliable in patients     with APLA.   "
231169|NCT00878150|"     The purpose of this study is to test the effectiveness of a telephone-based and in-person     Cognitive Behavioral Therapy (CBT) intervention for treating Major Depressive Disorder (MDD)     following Traumatic Brain Injury. Participants are randomly assigned to receive one of the     following: 1) Telephone-based CBT, 2) In-person CBT, or 3) Usual care (control).   "
231170|NCT00878163|"     This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when     given together with GDC-0449 with or without gemcitabine hydrochloride in treating patients     with metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs     used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Giving GDC-0449 together with erlotinib hydrochloride with or     without gemcitabine hydrochloride may kill more tumor cells.   "
231171|NCT00878176|"     The objective of this study is to determine whether bilateral sacral nerve stimulation with     First stage tined lead placement test is more effective than unilateral stimulation, among     patients with non obstructive urinary retention.   "
231172|NCT00878189|"     This is a phase 1, dose escalating study to determine the safety of PF-03084014 in patients     with advanced cancer and leukemia   "
231173|NCT00878202|"     The purpose of the SEDIC study is to test a home based heart failure patient clinical     follow-up and therapeutic education using telemedicine. This educational follow-up is based     on an interactive information system (SCAD) including a touch screen personal computer for     heart failure patient at home. An interactive algorithm has been developed to allow a self     management teaching to the patient.Furthermore, a specialized nurse provide a clinical data     follow-up.   "
231174|NCT00878215|"     Image-guided surgery is a new technology, which is used to create 3-D pictures that generate     a map of the liver. This map will allow surgeons to know the exact anatomical location of     their instruments, including instances when direct visualization is not possible. This study     is designed to determine the safety and feasibility of using image-guided techniques for     treatment of liver tumors. The overall goal of this study is to use image-guided surgery for     the improvement of the surgeon's ability to remove liver tumors.   "
231205|NCT00878813|"     Prospective observational multicenter study to evaluate copeptin as a prognostic marker in     patients with an acute cerebrovascular event. It includes four groups of patients, mainly     depending on type of initial therapy (intra-arterial thrombolysis, intravenous thrombolysis,     conservative treatment, TIA). The study takes place at the Emergency and neurological     Department of the University of Bern, Switzerland; Department of Neurology, Goethe University     of Frankfurt a.M. (Germany). Further participating centers are under discussion   "
231175|NCT00878397|"     Insecticide-treated nets (ITNs), and more recently long lasting insecticide nets (LLINs),     have been shown to effectively protect those groups most biologically vulnerable to the     burden of malaria across Africa. However, achieving universal coverage, especially in poor     and remote areas, has proved a particular challenge and there remains a need to explore     alternative delivery mechanisms. The recent introduction of universal primary education in     Kenya has meant that even the poorest households are sending at least one child to school,     providing a complementary, potentially equitable, mechanism through which to distribute     LLINs. The delivery of LLINs through schools will be piloted by Population Services     International in schools situated along the Tana River in North Eastern Kenya. This proposal     seeks to evaluate the impact of this programme on both household use of school donated, free     LLINs and the health of schoolchildren. The study hypothesis is that the free delivery of     long lasting insecticide nets (LLINs) through schools will increase household LLIN coverage     among younger siblings not enrolled in school and will reduce rates of malaria infection and     anaemia among school children. The study will be an impact evaluation of a programme     delivering LLINs through schools, which is to be implemented by Population Services     International (PSI)-Kenya. The programme will be implemented in 50 schools and due to     PSI-Kenya's roll out, the programme will be phased in over two years. will be phased in over     two years. The 50 schools will be randomly divided into two groups, the first 25 schools will     receive LLINs in 2009 and the second group will receive them in 2010. In each school, five     households will be randomly selected and household surveys will be conducted to collect     information on household net use and household demographic and socio-economic status. School     health surveys will be completed at the end of the programme to assess programme impact on     malaria infection and anaemia.   "
231176|NCT00878423|"     AT13387/0001 is a dose-finding study of an experimental anticancer agent. In accordance with     the protocol increasing doses of AT13387 are given to patients with advanced cancer who do     not have alternative treatment options. The preferred dose of AT13387 will be identified     according to the side effects experienced at different dose levels.   "
231177|NCT00878436|"     This trial is designed to investigate the safety, dosing schedule, and efficacy of the     combination treatment of Panobinostat (a histone deacetylase inhibitor) and hormone therapy     for recurrent prostate cancer. This trial is at its Phase II stage. As of July 23, 2013 Arm B     was closed to accrual, all the remaining slots in accrual will be allocated to Arm A.   "
231178|NCT00878449|"     This is a Phase 1 Study Evaluating the Safety of ABT-263 in Combination with     Etoposide/Cisplatin in Subjects with Small Cell Lung Cancer (SCLC).   "
231432|NCT00882830|"     The purpose of this study is to investigate the role of EMS as a preventive and therapeutic     tool of CIPNM. The investigators hypothesized that EMS will prevent the development of CIPNM     or have a beneficial role as a therapeutic means in case of CIPNM appearance.   "
231180|NCT00878475|"     In patients presenting with acute dyspnea in a pre-hospital setting, the early and correct     diagnosis may present a significant clinical challenge. Physical examination, chest     radiography, electrocardiography, and standard biological tests often fail to accurately     differentiate heart failure (HF) from pulmonary causes of dyspnea. Timely differentiation of     HF from other causes of dyspnea may permit the early institution of appropriate medical     therapy. Brain natriuretic peptide (BNP) and amino-terminal pro-brain natriuretic peptide     (NT-proBNP) have been proposed as early markers of HF and demonstrated to be useful for     diagnosing and excluding HF in the emergency department. A combination of BNP or NT-proBNP     testing and standard clinical assessment has been suggested to be superior to either tool     used in isolation. Some previous studies have also suggested that quantitative capnometry     (QC) may be useful in differentiating between cardiac and obstructive causes of respiratory     distress. Therefore, the investigators hypothesized that a new combination of NT-proBNP     testing, standard clinical assessment, and partial pressure of end-tidal CO2 (PetCO2) would     optimize evaluation and differentiation of acute dyspnea in a pre-hospital setting.      The aim of this study was to determine the accuracy of combination of QC, NT-proBNP, and     clinical assessment in differentiating acute HF from obstructive pulmonary disease     (COPD/asthma) as a cause of acute dyspnea in pre-hospital emergency setting.   "
231181|NCT00878501|"     The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in     patients with osteoarthritis of the knee and at what dose. This will be done by comparing the     effect of AZD1386 to placebo (inactive substance) on pain.   "
231182|NCT00878514|"     The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg     tablet with Xanax® 1 mg tablet under fed conditions.   "
231183|NCT00878527|"     The purpose of the study is to demonstrate the safety and functionality of the CircuLite     Synergy Pocket Circulatory Assist Device.   "
231184|NCT00878540|"     The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg     mirtazapine per day in healthy subjects.   "
231185|NCT00878553|"     SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is     currently available as Sonata as well as several generic formulations. Sonata and its     generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is     designed to become active 2-3 hours after ingestion. It is intended for use in people who     have no trouble falling to sleep but who often awaken in the middle of the night. This trial     will determine the best dose to prevent those awakenings.   "
231186|NCT00878566|"     The purpose of this study is to evaluate the effect of enhanced pharmacist care (patient     identification, assessment, education, prescribing/titration of antihypertensive medications     and close follow-up) on systolic blood pressure (BP) reduction in patients with poorly     controlled hypertension in the community setting.   "
231187|NCT00878579|"     The objective of this study is to evaluate the safety and effectiveness of the PDS System     compared to the surgical control of posterolateral fusion with autograft and pedicle screw     fixation for the treatment of one or two levels from L3-S1 to relieve back pain associated     with degenerative disc disease.   "
231188|NCT00878592|"     This study is to assess value of providing classes about dietary and life style modifications     to decrease or prevent weight gain, less occurrence or better control of weight gain     associated disorders such as high blood sugar, hypertension, heart or brain vessels     problems.Candidates for this study will be those who have got liver transplant within 6     months of their post transplant period.   "
231217|NCT00878969|"     The purpose of the study is to see how two classes of blood pressure     medications,angiotensin-converting enzyme inhibitors (Ace inhibitors) and angiotensin     receptor blockers (ARBs), differ in their long term effects on certain chemicals in the body     and on the carotid arteries.   "
231191|NCT00878631|"     This clinical trial will evaluate the ease of conducting a randomized trial on patients with     severe head injury who are cared for by paramedics in the out of hospital setting. The trial     will compare two different kinds of fluids that are commonly used to elevate blood pressure     and minimize the impact of the brain injury. The two solutions are a salt solution of     different concentrations. One is a normal saline solution similar to the consistency of human     blood and the other is a higher concentration mixed with a sugar that helps to keep the     solution in the blood stream longer. This study is conducted without patient consent at the     time of the study enrolment. The study will report on whether this trial is feasible in the     out of hospital setting before launching into a larger definitive trial.   "
231192|NCT00878644|"     Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in     which the body's temperature is lowered and maintained several degrees below normal for a     period of time, has been used to successfully treat adults who have experienced cardiac     arrest. This study will evaluate the efficacy of therapeutic hypothermia at increasing     survival rates and reducing the risk of brain injury in infants and children who experience a     cardiac arrest while out of the hospital.   "
231193|NCT00878657|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in     chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving intensity-modulated     radiation therapy together with gemcitabine may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of     intensity-modulated radiation therapy and to see how well it works when given together with     gemcitabine in treating patients with locally advanced pancreatic cancer.   "
231194|NCT00878670|"     In this study it will be investigated if patients with atopic dermatitis responding to EPOGAM     treatment, show a significant increase of dihomo-gamma-linolic acid in the blood.   "
231195|NCT00878683|"     This study is a pilot study of the safety, tolerability and efficacy of an investigational     central venous catheter device used in conjunction with a standard central venous catheter.     The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will     reduce catheter colonization by bacteria, and may decrease the rate of catheter-related     bloodstream infections.   "
231462|NCT00883220|"     Learning to self-manage urine flow may help people prevent or minimize persistent     complications from long-term indwelling urethral or suprapubic catheters.   "
231200|NCT00878748|"     This primary purpose of this study is to assess the efficacy and safety of Effexor XR in     preventing recurrence in Chinese patients with recurrent major depressive disorder (MDD)     following a 1-year maintenance treatment after an 8-week acute treatment and a 6-month     continuation treatment phases. The study will also collect data on the prevalence and pattern     of co-morbid anxiety and somatic symptoms and their impact on the recurrence of depression.   "
231201|NCT00878761|"     This Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, single     followed by multiple dose, dose escalation study designed to evaluate the safety,     tolerability, pharmacokinetics, immunogenicity, and impact of STX-100 on gene and protein     expression for αvβ6 related and TGF-β-inducible genes (including tubulointerstitial injury,     epithelial function, and IF/TA related genes) in renal transplant patients with biopsy.   "
231202|NCT00878774|"     It is estimated that 36 million Americans suffer from seasonal allergies and that ragweed is     the primary cause of autumn allergies, 87% of patients with ragweed allergy suffer     rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide     desensitising vaccine, currently being developed for the treatment of ragweed allergy.      The purpose of the present study is to evaluate the safety and tolerability of multiple     ascending doses of ToleroMune Ragweed in subjects in subjects with a documented history of     allergic rhinoconjunctivitis on exposure to ragweed pollen. The efficacy of ToleroMune     Ragweed will also be explored in these subjects using the Late Phase Skin Response, Early     Phase Skin Response and Conjunctival Provocation Test.   "
231203|NCT00878787|"     Theta-burst transcranial magnetic stimulation (TBS) is a type of repetitive transcranial     magnetic stimulation (rTMS) method that reduces the excitability of a small region of brain     for less than one hour. Since dystonia and spasticity may be associated with increased     excitability of motor cortex, we expect that by reducing the excitability of motor cortex     with TBS we will temporarily improve these symptoms and hopefully open avenues in the future     for the use of TBS as a new, non-invasive therapeutic intervention to aid in physical therapy     and symptom amelioration of dystonia and spasticity. We will test for motor improvement     during the hour immediately following TBS using tests of muscle function and quality of limb     movement.   "
231204|NCT00878800|"     Open-label, multicentre, dose-escalation Phase I/II study to evaluate safety, efficacy,     pharmacodynamics, and pharmacokinetics of the combination of PXD101 with doxorubicin     administered q 3 weeks in patients with advanced solid tumours. Once the Maximum Tolerable     Dose has been established, up to a total of 20-40 patients with Soft Tissue Sarcoma may be     enrolled at the MTD dose level to examine efficacy and safety in this specific patient     population. The trial is stopped if no more than 2 responses are seen among the first 20 of     these patients.   "
231206|NCT00878826|"     Enoxaparin is a type of low molecular weight heparin (LMWH), or anticoagulant, used to     prevent and treat blood clots. Formation of blood clots, or venous thromboemboli (VTE) in     pregnancy can have dangerous and even life-threatening effects on the mother and fetus.     Enoxaparin is the preferred medicine to prevent clotting in pregnant patients who are at risk     for VTE, because it has been studied to be safe and effective in pregnancy without any harms     to the fetus. Although this medication is routinely used and is recommended by several     prominent medical groups, the optimal dosing for prevention of VTE is still unclear. The     range of standardly prescribed dosing regimens of Enoxaparin includes 40mg daily and 1mg/kg     daily, but these two dosing strategies have never been compared in a head to head fashion.   "
231207|NCT00878839|"     A prospective evaluation of postoperative corneal aberrations and visual parameters (e.g.     visual acuity) in patients implanted with an AcrySof Toric IOL.   "
231208|NCT00878852|"     Cannabis use among Spanish adolescents has been increasing in the last decade. It has been     related to poor school achievement, delinquency, substance use and psychiatric disorders.     Furthermore, psychoactive substance use in adolescents presenting psychiatric disorders can     result in the development of substance use disorders or the worsening of psychopathology.     Thus, there's an urge to develop efficient interventions in the treatment of these disorders.     Therapeutic approaches based on cognitive-behavioural therapy and motivational interviewing     have demonstrated a limited efficacy in this population. Programs based on contingency     management have been reported to be useful both in adult and adolescents, too. But it still     remains unclear whether a combination of these therapeutic approaches is feasible and brings     a better cost-benefit relation.      The investigators' project aims to evaluate the added benefits of supplementing a standard     intervention on cannabis use, based on combined approach that includes motivational and     cognitive-behavioural elements, with a contingency management program. Therefore, pre and     post-treatment evaluation will be carried forward in a sample of 30 adolescents (aged 12-18)     that initiate treatment for cannabis use related disorder at the Child and Adolescent     Psychiatry Department of the Hospital Clinic in Barcelona. Participants will be randomly     assigned to a standard treatment group or an experimental group in which standard treatment     will be supplemented with a contingency management protocol. As a secondary objective, a     prospective assessment of neuropsychological performance related to cannabis use or     abstinence will be carried forward.   "
231209|NCT00878865|"     The objective of the study is to demonstrate the bioequivalence (BE) of two alprazolam 1 mg     tablets.   "
231210|NCT00878878|"     The design of this study is to conduct a comprehensive safety evaluation of the pulmonary     hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac     catheterization for clinical reasons.   "
231224|NCT00879073|"     The purpose of this study is to:        -  Test the maximum tolerated dose (MTD) of Bendamustine with whole brain radiation therapy          (WBRT)        -  To determine the plasma pharmacokinetics (a blood test to see how much of the drug is          getting into the patient's system and how long it lasts in the system) of Bendamustine        -  To determine the presence of Bendamustine in cerebrospinal fluid (CSF) (fluid from the          brain and spinal cord) of study patients Bendamustine is approved by the Food and Drug          Administration (FDA) for chronic lymphocytic leukemia. However, Bendamustine will be          used in this study as an investigational agent.   "
231225|NCT00879086|"     The purpose of this study in patients with advanced breast cancer is to compare the incidence     and severity of neuropathy adverse events for the two treatment groups (eribulin versus     ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events     (NCI CTCAE version 3.0) grading.   "
231211|NCT00878891|"     An increased risk of adverse outcome is noted for diabetic patients admitted in surgery     intensive care units (ICU). Tight glycemic control with intensive insulin therapy     dramatically reduces in-hospital mortality and adverse outcome. Devices recording     continuously interstitial glucose monitoring (CGM) may be an aid in patients of ICU in whom     normoglycemia become a target.      The mini-invasive device (Glucoday®) should provide real-time glucose concentrations in order     to quickly adjust insulin infusion rates. The objective of MARGE study is to compare percent     of time in normoglycemia based on conventional monitoring (discontinuous glucose monitoring)     and Glucoday to conventional monitoring alone. The MARGE study is a multicenter (2 centers),     randomized, single blind trial.      Several studies have shown that hyperglycemia is associated with poor outcomes in     hospitalized patients. Postoperative glucose levels are a significant predictor of infection     rates after cardiac surgery and death rate. Based on these observational studies, a     randomized controlled intervention trial in surgical ICU patients demonstrated that intensive     insulin therapy reduced the overall in-hospital mortality by 34 % and stream infection by 46     %. Using continuous glycemic monitoring (CGM) it has been shown that intensive insulin     therapy based on discontinuous glucose monitoring revealed that normoglycemia is achieved     only 22 % of time. The researchers' aim is to determine if real time CGM with a new     generation mini invasive device, Glucoday® S, would allow quickly adjusting insulin infusions     rates according to interstitial glucose levels and decreasing both hyperglycemic and     hypoglycemic excursions. This study will further investigate whether application of real time     CGM to titrate insulin therapy to target glycemia in a tight range (80-110 mg/dl) can improve     diabetic patient outcome after coronary artery bypass grafting (CABG).   "
231212|NCT00878904|"     RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving panobinostat together with epirubicin may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when     given together with epirubicin in treating patients with metastatic malignant solid tumors.   "
231213|NCT00878917|"     The study aims to prospectively prove the equivalence of the test product and the reference     solution in lowering intraocular pressure in patients with open angle glaucoma and ocular     hypertension. For this purpose the patients are randomized into two sequences of study drug     administration in a crossover study with an adequate wash-out period.   "
231214|NCT00878930|"     The objectives of this study is to obtain information of Faslodex use in the treatment of     breast cancer in the clinical practice in Argentina.   "
231215|NCT00878943|"     In an earlier study, sildenafil citrate administered to patients of PAH led to improvement in     pulmonary arterial pressure, cardiac output, quality of life, and other parameters as     compared to placebo. This protocol provides mechanism for patients who have clinical     deterioration on other PAH approved therapies to have access to sildenafil prior to marketing     authorization in India.   "
231216|NCT00878956|"     With over one million operations a year, cardiac surgery with cardiopulmonary bypass is one     of the most common major surgical procedures worldwide (1). Acute kidney injury is a common     and serious postoperative complication of cardiopulmonary bypass and may affect 25% to 50% of     patients (2-4). Acute kidney injury carries significant costs (4) and is independently     associated with increased morbidity and mortality (2,3). Even minimal increments in plasma     creatinine are associated with an increase in mortality (5,6).      Multiple causes of cardiopulmonary bypass-associated acute kidney injury have been proposed,     including ischemia-reperfusion, generation of reactive oxygen species, hemolysis and     activation of inflammatory pathways (7-10). To date, no simple, safe and effective     intervention to prevent cardiopulmonary bypass-associated acute kidney injury in a broad     patient population has been found (11-14).      Urinary acidity may enhance the generation and toxicity of reactive oxygen species induced by     cardiopulmonary bypass (10,15). Activation of complement during cardiac surgery (16) may also     participate in kidney injury. Urinary alkalinization may protect from kidney injury induced     by oxidant substances, iron-mediated free radical pathways, complement activation and tubular     hemoglobin cast formation (9,17,18). Of note, increasing urinary pH - in combination with     N-acetylcysteine (19,20) or without (21) - has recently been reported to attenuate acute     kidney injury in patients undergoing contrast-media infusion.      In a pilot double-blind, randomized controlled trial the investigators found sodium     bicarbonate to be efficacious, safe, inexpensive and easy to administer. These findings now     need to be confirmed or refuted by further clinical investigations in other geographic and     institutional settings.      Accordingly, the investigators hypothesized that urinary alkalinization might protect kidney     function in patients at increased risk of acute kidney injury undergoing cardiopulmonary     bypass needs to be confirmed in an international multicenter, double-blind, randomized     controlled trial of intravenous sodium bicarbonate.   "
231221|NCT00879034|"     This is an open label single arm feasibility trial. A combination of two oral agents     (pravastatin and lonafarnib) and one intravenous (IV) agent (zoledronic acid) will be     administered at doses and schedule currently applied in pediatrics. These agents all target     farnesylation pathways at different points. Our goal is to inhibit farnesylation of abnormal     lamin, the disease-causing protein in Hutchinson-Gilford Progeria Syndrome and progeroid     laminopathies (henceforth progeria). The drugs will include the intravenous bisphosphonate     zoledronic acid, oral HMG co-reductase inhibitor pravastatin and the oral farnesyltransferase     inhibitor (FTI) lonafarnib (SCH 66336). Patients with genetically confirmed progeria will be     eligible for this protocol. Treatment will be initiated for 4 weeks duration and may be     extended depending on tolerability. This study will assess the feasibility of this treatment     regimen in the first 4 weeks. If tolerated for 4 weeks, patients can be treated with this     regimen for up to 6 months.   "
231222|NCT00879047|"     The proposed studies will examine the extent of pharmacokinetic and pharmacodynamic     interactions between alcohol and various antiretroviral therapies in those with HIV/AIDS,     HIV/HCV co-infection, mild HCV and healthy subjects.   "
231223|NCT00879060|"     Hypertrophic Cardiomyopathy (HCM) is the most common genetic cardiomyopathy and remains the     leading cause of sudden cardiac death in young people and an important cause of heart failure     symptoms and death at any age. In HCM, pathological remodeling of the left ventricle     involving myocardial fibrosis is likely a major contributor to cardiac dysfunction and also a     nidus for the generation of ventricular arrhythmias. Serum markers of collagen turnover have     been shown to reliably reflect the magnitude of myocardial fibrosis in a variety of     cardiovascular diseases. In addition, aldosterone antagonist drugs have been shown to     decrease fibrous tissue formation in the myocardium in certain pathologic cardiovascular     states in which aldosterone production is increased. In HCM, aldosterone production is     up-regulated and has been implicated in the formation of myocardial fibrosis.      Therefore, the specific aims of this proposal are to:        1. assess serum markers of collagen turnover at baseline and correlate these findings with          a variety of clinical and morphologic disease parameters        2. examine the effects of a 12-month treatment with the aldosterone antagonist          spironolactone on magnitude of fibrosis as measured by serum markers of collagen          turnover as well as changes in clinical and morphologic disease parameters.      The results of this proposal will offer important insights into the clinical significance of     myocardial fibrosis in this primary genetic cardiomyopathy. The demonstration that     spironolactone decreases fibrosis and improves clinical course would provide the rational for     a larger multicenter clinical trial evaluating this novel therapy for improving clinical     outcome in patients with HCM.   "
231226|NCT00879099|"     The aim of the study is to investigate the effect of antidepressant paroxetine, on the plasma     levels of timolol and its main metabolites after topical application of ophthalmic timolol     products.      This will be a phase I, randomised, 4-phase cross-over study in healthy volunteers. Healthy     male volunteers aged 18 - 40 years will be enrolled.      Placebo or paroxetine will be given for three days after which 1 drop of timolol product will     be administered once in both eyes.      The duration of the paroxetine or placebo treatment period will be 3 days. There will be four     different treatment periods. A washout between the study periods will be at least 4 weeks.   "
231227|NCT00879112|"     A Phase 2 randomized, placebo controlled study assessing the efficacy, safety, and     tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12     weeks followed by a 6-week off drug phase.   "
231228|NCT00879125|"     This is a retrospective review of patients who have undergone bariatric surgery at VUMC and     who have type 2 Diabetes and/or dyslipidemia. The investigators have previously found that     gastric bypass significantly improves diabetes 6-12 months after surgery. The investigators     are interested in looking at the longer term results after surgery.   "
231229|NCT00879138|"     A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have     a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and     osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both     single and multiple oral doses of VA106483 at three dose levels, under conditions of     controlled hydration.   "
231230|NCT00879151|"     In the face of scant literature on the subject, the investigators aim to more clearly     identify effective treatments for adolescent bulimia nervosa (BN) through a treatment study     comparing two current treatments (Cognitive Behavioral Therapy for Adolescents, CBT-A and     Family Based Therapy for Bulimia Nervosa, FBT-BN) for the disorder in comparison with a     non-specific therapy, Supportive Psychotherapy for Adolescent Bulimia (SPT). Additionally,     the investigators hope to provide clinicians with information on treatment efficacy,     variables that might influence outcome, and processes that may affect treatment efficacy that     will guide them in their efforts to treat adolescent BN.   "
231231|NCT00879164|"     RATIONALE: A stellate ganglion nerve block may help relieve hot flashes in women.      PURPOSE: This clinical trial is studying how well a stellate ganglion nerve block works in     treating women with hot flashes.   "
231292|NCT00879970|"     This study will answer two separate questions.      The first question is to test the cardiovascular effects of long-term treatment with     rosiglitazone or pioglitazone when used as part of standard of care compared to similar     standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who     have a history of or are at risk for cardiovascular disease.      The second question will compare the effects of long-term supplementation of vitamin D on     death and cancer   "
231232|NCT00879177|"     In total, 260 patients with pre- and stage I hypertension, who are regular smokers, will be     randomized to: varenicline alone or varenicline plus behavioral therapy. Patients in both     conditions will receive varenicline (titrated to a maximal dose of 1.0 mg twice daily) for 12     weeks along with standard smoking cessation therapy and regular carbon monoxide (CO) and     cotinine monitoring. A significantly higher proportion of behavioral therapy patients are     expected to achieve and maintain long durations of abstinence than patients receiving     varenicline alone. Clinic and 24-hour blood pressure (BP) and heart rate (HR) will be primary     clinical outcomes. The investigators expect that BP and HR will decrease more among     behavioral therapy than non-behavioral therapy patients and reductions in smoking may mediate     decreases in these indices.   "
231233|NCT00879190|"     Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters)     surrounding the baby inside of a pregnant woman prior to delivery. This infection is somewhat     common and is routinely treated with antibiotics given to the mother both before and after     the baby is born. Currently it is not known what is the best choice of antibiotics to treat     this type of infection, but commonly used treatments include Unasyn (ampicillin/sulbactam) or     ampicillin/gentamicin. We plan to compare these two different antibiotic regimens to see if     one is better than the other at treating and preventing bad outcomes from chorioamnionitis in     women and babies.   "
231234|NCT00879203|"     LO5 study: The investigators are inviting a new group of youth (ages 7-16) who have been     recently diagnosed with type 1 diabetes and their non-diabetic siblings. These youth will     complete cognitive tests and a MRI scan of the brain. This scan uses strong magnets to obtain     pictures and does not involve any radiation or injections. The investigators will recruit     patients within three months of their diagnosis date. The study entails 1 study visit that     lasts 3.5 hours. Evening and weekend times are available. The investigators plan to enroll     135 participants.      HY5 study: The investigators are inviting a cohort of youth and young adults (ages 9-21) with     type 1 diabetes and their non-diabetic siblings for a follow-up to a study they have already     completed. This group of people will complete several memory and thinking tests along with     several MRI scans of their brain, just as they did at their previous visits. The     investigators plan to enroll 150 participants.   "
231235|NCT00879216|"     The main purpose of this study is to investigate whether the hypotensive effects of an     alpha-blocker are increased when VA106483 is given at the same time.   "
231236|NCT00879229|"     Ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary     hypertension (PH). Based on research suggesting a role for endothelin-1 in the pathogenesis     of idiopathic pulmonary fibrosis (IPF) and the poor prognosis for patients with IPF who are     also diagnosed with PH, this study was designed to evaluate the effectiveness and safety of     ambrisentan in that patient population.   "
231237|NCT00879242|"     This study will assess the safety and efficacy of deferasirox in patients with cardiac MRI     T2* < 20 msec.   "
231238|NCT00879255|"     The immediate objective of this project was to evaluate the clinical effectiveness of a     telemental health modality (video-teleconferencing) for providing an evidence-based group     intervention (Cognitive Processing Therapy; CPT) to rural OIF/OEF Reservists, National     Guardsmen, and veterans suffering with PTSD.   "
231239|NCT00879268|"     This is a pilot trial of centrifugal machine preservation of donor livers for transplantation     using a novel preservation solution.   "
231242|NCT00879307|"     There is sound evidence that quetiapine is effective in the treatment of manic and depressive     episodes associated with Bipolar Disorder (BD) (Yatham et al 2006). However, even with the     development of effective new treatment options, not all patients respond to treatments     available. Biological markers have been investigated as predictors of response to treatment     and of remission of symptoms. This would explain in part the individual's differences in the     response to treatment, taking into account the genetic variability plus environmental factors     influencing specific biological markers. A potential biological marker of response to     treatment in BD would be the levels of neurotrophins, as they are, in fact, altered during     acute mood episodes (Cunha et al 2006). Among neurotrophins, the Brain-Derived Neurotrophic     Factor (BDNF) has been repeatedly and consistently reported to be associated with BD     physiopathology (Post 2007). Furthermore, medications that are known to be effective in BD,     like lithium and divalproex, increase BDNF levels.   "
231243|NCT00879320|"     The purpose of this study is to understand the relationship between ADHD and the overall     health of someone with ADHD. People who have ADHD have trouble paying attention,     concentrating, organizing, and planning. They may have trouble in school, at work, and at     home. The investigators are interested in finding out whether these difficulties have had any     influence in the past, current, or future health problems of someone with ADHD. About 100     people with ADHD and 100 people without ADHD will take part in this research study, all     through Massachusetts General Hospital (MGH).   "
231244|NCT00879333|"     This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients     with advanced gastric cancer which has progressed after one or two lines of prior     chemotherapy.   "
231245|NCT00879346|"     Phase I, randomised, open label, 3-period crossover study in healthy male subjects to     investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the     safety and tolerability of AZD8931.   "
231277|NCT00879775|"     Pain is a most common symptom and it has a high impact on quality of life in cancer patients.     Many cancer patients have received opioid therapy, but also many of them have suffered from     side effects of opioids. Drowsiness and confusion are common side effects of opioids.     Caffeine is a well known psychostimulant,and it is widely used as an analgesics. Thus, the     investigators aimed to prove the efficacy of intravenous caffeine administration as an     adjuvant analgesics to opioids. At the same time, the investigators tried to find that the     side effects of opioids could be ameliorated by caffeine.   "
231246|NCT00879359|"     The purpose of this study is to find out whether the addition of a drug called Avastin     (avastin) to the two-drug combination of carboplatin and paclitaxel shrinks tumors better     than the two-drug combination alone in the treatment of endometrial cancer. Avastin is a     humanized monoclonal antibody (a type of protein that is normally made by the immune system     to help defend the body from infection and cancer) produced by Genentech, Inc. Avastin is an     antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a potent,     specific growth factor with a well defined role in normal and abnormal blood vessel     formation. It is present in a wide variety of normal tissues, but is produced in excess by     most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood     vessels that feed the tumor cells.   "
231247|NCT00879372|"     One of the main challenges in the treatment of Bipolar Disorder (BD) is to achieve better     functioning outcomes after syndromal recovery. Even treatment-responsive patients, who remain     symptomatically well for extended periods of time, frequently demonstrate sub-threshold     symptoms and continuing psychosocial morbidity and cognitive impairment. The cognitive     impairment that persists during interepisode periods stands out as a major correlate of     functional impairment, and may be a core aspect of the BD pathophysiology.      In this context, tianeptine stands out as a therapeutic agent with unique properties, which     match most of the conditions found in BD.      This is an enriched maintenance study of the use of tianeptine as an adjunctive therapy in     bipolar depression. All participants will receive tianeptine in an open label manner for a     period of two months, following which they will be assigned randomly to the treatment with     tianeptine or placebo in a double-blind fashion for six months. All patients will remain on     treatment as usual for the duration of the trial. Along with clinical response, the     investigators will prospectively evaluate the improvement in working and declarative memory,     two cognitive prefrontal- and hippocampus-dependent processes, respectively, and the effects     of tianeptine on serum BDNF levels.   "
231248|NCT00879385|"     OBJECTIVES:      Primary Objectives      1.To evaluate the safety and feasibility of the sequential use of a DNA methyltransferase     (DNMT) inhibitor (decitabine) with a targeted biological agent against EGFR (panitumumab) for     KRAS wild type tumors in the second or third line treatment of advanced metastatic colorectal     cancer.      Secondary Objectives        1. To examine re-expression or a reduction in promoter methylation in genes involved in          tumor suppressor pathways known to be important in colorectal cancer (CRC) or involved          in EGFR signaling pathway.        2. Evaluate overall response (OR = CR +PR) according to RECIST criteria at 2, 4, and 6          cycles. Progression free survival, measured as the first evidence of tumor growth from          the start of treatment will also be assessed.        3. Measure CEA levels at the beginning of each cycle to examine if they correlate with          treatment response or disease progression.   "
231249|NCT00879398|"     The objective of this study is to determine the problems and questions of safety and efficacy     of Toviaz® under the standard conditions of usage.   "
231250|NCT00879411|"     Practical experience report (PER) investigating the effect of Micardis® on the average 24h     blood pressure of therapy-naive and therapy-experienced patients   "
231251|NCT00879424|"     The goal of this clinical trial is to investigate the therapeutic role of vitamin D     supplementation in a subset of patients with atopic dermatitis (AD): children with disease     onset or worsening in the winter. The investigators hypothesis is that (1) vitamin D     supplementation in patients with either wintertime onset or exacerbation of AD will improve     Eczema Area and Severity Index (EASI) scores, and (2) vitamin D supplementation will improve     the Investigator's Global Assessment.   "
231463|NCT00883233|"     The purpose of this study is to compare the tolerability of 3 treatment regimens containing     Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5%     Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The     efficacy of the four treatment regimens will also be evaluated.   "
231252|NCT00879437|"     Currently, there are few effective treatments for the following aggressive brain tumors:     glioblastoma multiforme, anaplastic astrocytoma, gliomatosis cerebri, gliosarcoma, or     brainstem glioma. Surgery and radiation can generally slow down these aggressive brain     tumors, but in the majority of patients, these tumors will start growing again in 6-12     months. Adding chemotherapy drugs to surgery and radiation does not clearly improve the cure     rate of children with malignant gliomas.      The investigators are conducting this study to see if the combination of valproic acid and     bevacizumab (also known as AvastinTM) with surgery and radiation will shrink these brain     tumors more effectively and improve the chance of cure.   "
231253|NCT00879450|"     Children with a torticollis are usually referred for physiotherapy where they are evaluated,     and given exercises as well as education to treat the condition. This study is being done in     order to compare 2 methods of sharing information with parents of children with torticollis.   "
231254|NCT00879463|"     In cardiac operations under cardiopulmonary bypass(CPB), monitoring of brain tissue oxygen     saturation with infrared spectrophotoscopy leads to a reduction of the number of packed red     cell(PRC) transfusions during the period of extracorporeal circulation.   "
231255|NCT00879476|"     The study was conducted as an open label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover bioavailability study comparing Ramipril capsules 10 mg     of OHM Laboratories Inc., USA with ALTACE® (ramipril) capsule 10 mg manufactured by King     Pharmaceuticals Inc., Bristol, TN 37620, USA in healthy, adult, male, human subjects under     fasting condition.   "
231256|NCT00879489|"     The study uses a molecule or particle that is found only on cancer cells and is unique to     cancer cells, as it is not detected on normal tissue. The molecule is known as oncofetal     antigen or OFA. Because OFA is unique to cancer, the investigators feel OFA could be used to     educate the patients' own defenses to more effectively fight the cancer on his or her own,     that he or she is harboring. Although investigators found OFA to be present in large     concentrations on all cancers, it was found to be especially abundant in breast cancers.     Therefore, the investigators feel that this molecule would be a good target for stimulating     patient defenses especially against breast cancer cells. To accomplish this, certain defense     cells (immune cells)will be washed out from the patients' blood using a machine to which the     patient is connected through two small cannula placed into veins located in the patients'     arms those cells will be manipulated in the laboratory with artificially engineered OFA.     These reeducated cells will be injected into the skin of patients. There will be a series     of three skin injections in 4 week intervals. It is hoped that this treatment will convert     the patients' defenses to a point that effective anti-cancer responses will be induced.     Effectiveness of the treatment will be monitored with blood tests and assessment of the size     of the cancers.   "
231260|NCT00879541|"     The aim of this study are to        -  assess the efficacy of Biostate® [Study Product (SP)] in subjects with Haemophilia A        -  compare the pharmacokinetics of Biostate® [SP] with the previously marketed product          Biostate® (here referred to as Biostate® [Reference Product (RP)]).      This study is divided into 3 parts:      Part 1: Cross-over pharmacokinetic (PK) component. PK subjects will be randomised to     determine the order in which they receive the two study products. This part of the study is     double-blinded.      Part 2: Efficacy component. All subjects will receive Biostate® [SP] as required to manage     their haemophilia condition for an estimated period of 6 months (or minimum of 50 exposure     days) to assess efficacy and safety of the product. This part of the study is open-label.      Part 3: Repeat pharmacokinetic assessment. Subjects who participated in Part 1 (PK component)     will undergo a repeat PK assessment on Day 180 following administration of Biostate® [SP].   "
231261|NCT00879554|"     The purpose of the study is to determine safety and tolerability of CVX-045 in patients with     advanced solid tumors.   "
231262|NCT00879580|"     The purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the     Enterprise(TM) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.   "
231263|NCT00879593|"     Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting motoneurons,     with a prevalence around 5/100.000. Respiratory muscle involvement is a major feature in ALS     and remains the main prognostic factor. Timing and rate of progression of this respiratory     muscle involvement is also highly variable among individuals.      Respiratory manifestations justify a careful follow up including clinical evaluation,     pulmonary function tests and blood gases. Prognostic value of respiratory muscle assessment     has been clearly demonstrated in ALS, although several cut off values have been published.     The clinical benefit of non invasive ventilation (NIV) is well established in ALS, but the     optimal criteria for its initiation remain debated .      The 1999 consensus for NIV selected classical criteria to consider NIV in patients with     respiratory symptoms suggesting hypoventilation: daytime hypercapnia (PaCO2 > 45 mmHg),     nocturnal SaO2 < 89 % more than 5 consecutive minutes and for progressive neuromuscular     disorders (NMD) (mainly ALS), a vital capacity (VC) < 50 % pred or a PImax < 60 cmH2O.      Besides daytime clinical and PFT assessment, nocturnal evaluation is essential in ALS. The     prevalence of sleep apnea ranges from 16 % to 76 %.      Transcutaneous PCO2 (tcPCO2) is an attractive technique to evaluate non invasively nocturnal     hypoventilation. The technique is well validated in different settings. Its use in     neuromuscular disorders (NMD) is recent. In particular one study has demonstrated a high     predictive value of tcPCO2 for the development of daytime hypoventilation within 1 year. To     our knowledge, this technique has not been specifically assessed in ALS. There is a potential     role for nocturnal PtcCO2 monitoring in the close follow up of ALS patients. Indeed, a close     respiratory follow up of ALS patients is essential to determine the optimal timing of NIV,     avoiding the occurence of unexpected acute respiratory failure.   "
231264|NCT00879606|"     This is a prospective, randomized (1:1), double-blind, multi-center, Phase II clinical study     to test the safety and efficacy of a recombinant chimeric anti-tissue factor antibody     (ALT-836) versus placebo in patients with sepsis and acute lung injury/acute respiratory     distress syndrome (ALI/ARDS). This study was divided into two parts and the first part of the     study has been completed. In the first part of the study, sixty patients were randomized at a     1:1 ratio to receive one dose of the study drug or placebo. In the second part of the study,     ninety patients will be randomized at a 1:1 ratio to receive a multi-dose treatment regimen     of single doses every 72 hours up to a maximum of 4 doses of the study drug or placebo,     provided there are no safety concerns.   "
231340|NCT00880607|"     This study plans to learn more about preventing pain in children who are having posterior     spinal fusion surgery using two different kinds of morphine (a pain medicine). Also, this     study plans to learn about individual differences in the how the different kinds of morphine     work in children.      Subjects are being asked to be in this research study because they are having spinal fusion     surgery, will have pain some of the time and will be getting morphine during and after     surgery to help control their pain.   "
231265|NCT00879619|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel and     prednisone together with sunitinib malate may kill more tumor cells.      PURPOSE: This pilot phase I/II trial studies the side effects and best way to give docetaxel     and prednisone together with sunitinib malate and to see how well it works in treating     patients with prostate cancer that progressed after hormone therapy.   "
231266|NCT00879632|"     There is sound evidence that quetiapine is effective in the treatment of manic and depressive     episodes associated with Bipolar Disorder (BD) (Yatham et al 2006). However, even with the     development of effective new treatment options, not all patients respond to treatments     available. Biological markers have been investigated as predictors of response to treatment     and of remission of symptoms. This would explain in part the individual's differences in the     response to treatment, taking into account the genetic variability plus environmental factors     influencing specific biological markers. A potential biological marker of response to     treatment in BD would be the levels of neurotrophins, as they are, in fact, altered during     acute mood episodes (Cunha et al 2006). Among neurotrophins, the Brain-Derived Neurotrophic     Factor (BDNF) has been repeatedly and consistently reported to be associated with BD     physiopathology (Post 2007). Furthermore, medications that are known to be effective in BD,     like lithium and divalproex, increase BDNF levels.   "
231267|NCT00879645|"     This is a Phase 1 study to assess the pharmacokinetics (PK) of IK-1001 (sodium sulfide) in     healthy volunteers as well as in subjects with varying degrees of impaired renal function. A     total of 28 subjects will be enrolled into the study over a 6 month period. There will be 4     cohorts. The first cohort will consist of subjects with mild renal impairment, the fourth     cohort will be subjects with intermediate renal impairment and the third cohort will be     subjects with severe renal impairment and the second cohort will consist of normal healthy     subjects. All subjects will receive the study drug for 3 hours as a single intravenous (IV)     infusion and will be followed over a 7 day period.   "
231278|NCT00879788|"     The study was conducted as an open label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover bioavailability study comparing ramipril 10 mg capsules     of Ohm Laboratories Inc., with Altace® capsule 10 mg (containing ramipril 10 mg) manufactured     by King Pharmaceuticals Inc, Bristol and Distributed by Monarch Pharmaceuticals Inc, Bristol     in healthy, adult, male, human subjects under fed condition.   "
231288|NCT00879918|"     The investigators hypothesize that African Americans (AAs) smoke more for positive     reinforcement from nicotine with a peak-seeking pattern of smoking (smoking individual     cigarettes more intensively with greater intake of nicotine and tobacco smoke toxins), while     whites smoke more for negative reinforcement with a trough-maintaining pattern (avoiding     withdrawal by maintaining more consistent nicotine levels throughout the day by means of a     more regular smoking pattern). The investigators believe that these patterns are linked to     identifiable racial differences in nicotine pharmacology and that there will be associated     racial differences in responses to pharmacologic interventions.   "
231268|NCT00879658|"     The purpose of this study is to determine the dose-response curve for the MRI-based efficacy     of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis     (RRMS), and to characterize its safety and tolerability for the selection of an optimal dose     in a later phase III study.      Study Design Rationale An adaptive design was chosen to characterize the dose response curve     of BAF312. In a first period of study (Period 1), three doses of BAF312 and placebo are     tested for MRI efficacy. Based on an interim analysis (IA) after 3 months of treatment, two     additional active doses for period 2 have been selected , thus allowing to optimize the     overall determination of the dose response curve with 5 data points of active treatment, and     placebo. The doses are kept blinded. The use of Modeling and Simulation allows to establish     the full range and dynamics of the dose-response curve in silico, and hence the definition of     the optimal dose for later phase III studies.      The choice of placebo as treatment control is essential to obtain information on the specific     compared to non-specific effects of active treatment and provides the best way of evaluating     the efficacy and of assessing the true safety and tolerability profile of BAF312. Short-term     placebo exposure (6 (Period 1) or 3 (Period 2) months, respectively) is unlikely to lead to     longer term differences in outcomes [Polman, 2008]. The use of an adaptive design strategy     contributes to a significant reduction of placebo exposure, both in terms of the number of     patients and duration, as compared to conventional trial models.      Patients having completed the study within the protocol may be eligible for the Extension     Phase study where they receive long-term BAF312 treatment (a separate protocol).   "
231269|NCT00879671|"     The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein     and zeaxanthin. The highest concentrations of lutein and zeaxanthin are found in the fovea.     Since light entering the eye passes through the MP before reaching the photo receptors it     absorbs a significant portion of short-wavelength light. There is evidence that this     absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen     species are protective for the retina.      Age-related macular degeneration is the leading cause of blindness among developed countries.     The pathogenesis of this disease remains unknown. There is, however, evidence that low fruit     and vegetable consumption increases the risk of Age-Related Macular Degeneration (AMD).     Accordingly, it has been hypothesized that lutein supplementation may be beneficial in AMD.     The present study investigates whether 6 months lutein supplementation increases MP optical     density (OD), influences visual acuity, depth and dimension of central scotoma and alters     symptoms in patients with AMD.   "
231270|NCT00879684|"     The purpose of this study is to determine the safety and tolerability of CVX-060 in patients     with advanced solid tumors.   "
231341|NCT00880620|"     This study examines the efficacy of three doses of IPX066 as compared to placebo in     Parkinson's disease.   "
231342|NCT00880633|"     The purpose of this retrospective study is to determine the degree to which a biliary stent     affects EUS staging accuracy of ampullary tumors.   "
231343|NCT00880646|"     This study aims to investigate the effect of supplement containing L-arabinose and     indigestible dextrin on body mass index, body fat mass, abdominal circumference, visceral fat     mass, and serum biochemical parameters in overweight subjects.   "
231271|NCT00879697|"     Background: Muscle atrophy and reduced leg strength are related to exercise intolerance in     patients with intermittent claudication (IC), suggesting that strength training (ST) could     improve exercise performance in these patients.      Objective: Analyze the effects of ST in walking capacity in patients with IC comparing with     walking training (WT) effects.      Intervention: Patients were randomized into ST and WT. Both groups trained twice a week, for     12 weeks, at the same rate of perceived exertion. ST consisted of 3 sets of 10 repetitions of     whole body exercises. WT consisted of 15 two-minute bouts of walking intercalated with 2     minutes of resting.      Measurements: Walking capacity, peak VO2, walking economy, ankle brachial index, ischemic     window and knee extension strength   "
231272|NCT00879710|"     HMG CoA reductase inhibitors (statins) are commonly used to treat high cholesterol (HC) in     both type 1 and type 2 diabetes mellitus (DM). Several studies have shown benefits of statin     among patients of type 2 DM, however, no such data is available for patients with type 1 DM.      It is known from studies on cholesterol metabolism using surrogate markers that patients with     type 1 DM have higher cholesterol absorption compared to normals and those with type 2 DM     have higher cholesterol synthesis. Since statins inhibit synthesis, patients with type 1 DM     may not have a good response and may respond better to cholesterol absorption inhibitors. The     purpose of this study is to determine the cholesterol lowering effects of cholesterol     absorption inhibitors and cholesterol synthesis inhibitors in subjects with type 1 and type 2     diabetes mellitus.   "
231273|NCT00879723|"     Burn injury patients undergo a series of metabolic changes that, if untreated, could lead to     reduced health outcomes. Nutrition is thought to play a vital role in post-burn recovery. The     research team developed a novel vitamin and mineral supplementation protocol based on current     scientific literature. The study will test the hypothesis that the novel vitamin and mineral     supplement regimen will improve adult patient recovery from burn injury.   "
231274|NCT00879736|"     This study is being carried out to see if patients make the lifestyle changes or take their     medication as instructed by their doctor during their visit as a result of the T.H.T.     patient-education training. Proper information exchange between doctors and patients is an     important part of quality health care. Although many patients would like more information,     they often do not ask for it directly during doctor-patient visits. The patient-training in     this study specifically aims at improving patient participation during medical appointments     by building communication skills such as requests for information and sharing health concerns     with the doctor.   "
231275|NCT00879749|"     The main purpose of this study is to determine the safety of weekly injections of Nexvax2     given for three weeks to patients with coeliac disease who have been on a gluten-free diet.      The second purpose of this study is to compare the immune response over the three week study     period in coeliac disease patients given Nexvax2 compared to those given saline.   "
231276|NCT00879762|"     The purpose of this research is to compare the ability of a new investigational smallpox     vaccine called IMVAMUNE® to produce a strong immune response against smallpox disease if     given as one single, higher dose compared with two lower doses given one month apart. Another     purpose of the study is to see how quickly someone might be protected against smallpox.     Volunteers will be vaccinia-naïve adults age 18 and older (born after 1971) divided into 2     groups. Volunteers in Group A will receive a high dose of vaccine given in 2 shots on day 0     followed by a placebo (inactive substance) shot on day 28. Group B will receive the standard     dose of vaccine and placebo given in 2 shots on day 0 followed by a standard dose shot on Day     28. Study participation will include 10 planned study visits over approximately 7 months.   "
231311|NCT00880217|"     The purpose of this study is to evaluate the efficacy and safety/tolerability of 3 different     dosages of JNJ-31001074 compared with placebo in adult patients with     attention-deficit/hyperactivity disorder (ADHD).   "
231279|NCT00879801|"     There are few longitudinal studies in the Caucasian population and even less in the Italian     population in subjects with impaired glucose regulation to allow:        1. An estimate of the rate of conversion to type 2 diabetes;        2. To identify subjects at risk; and        3. To assess the physiopathologic mechanisms responsible for the conversion.      In order to set up a longitudinal study capable of defining the above parameters it is     mandatory that the physiological, biochemical, and, genetic markers specific for IGR are     identified. The goals of the present research proposal are:        1. To clarify the physiological mechanisms responsible for IGR;        2. To identify the biochemical and beta-cell auto-immune parameters present in IGR;        3. Identify genetic markers.      The subjects who will be identified will add up to other 900 individuals who will be     recruited as part of a follow-up program sponsored by the Italian Society of Diabetes,     specifically designed to assess conversion rate to diabetes.   "
231280|NCT00879814|"     The purpose of this study is to evaluate the safety and tolerability of an investigational     meningococcal B rLP2086 vaccine in healthy adults.   "
231281|NCT00879827|"     The purpose of this study is to evaluate the immune response and reactogenicity of GSK     Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine,     administered concomitantly as a three-dose primary vaccination course.   "
231296|NCT00880022|"     No studies have tested the potential benefit of the Flexitouch® truncal/chest garments on     reducing truncal lymphedema in breast cancer survivors (BCS) or the theoretical added benefit     of applying truncal/chest pneumatic compression therapy to open lymph channels in individuals     who have only limb lymphedema or its impact on the trunk/chest. The purpose of this two-part     study is to fill gaps related to: 1) the impact of the Flexitouch® System on truncal     lymphedema, and 2) the therapeutic benefit of truncal /chest pneumatic compression therapy     for arm lymphedema.      Hypotheses:      Part One: BCS with arm and truncal lymphedema. H1: Arm swelling (as measured by bioelectrical     impedance & arm girth in cm) will be reduced after 10 sessions with the Flexitouch® System.      H2: Truncal swelling (as measured circumferentially) will be reduced after 10 sessions with     the Flexitouch® System.      H3: The number, severity, and intensity, of physical and psychological symptoms (as measured     by the Lymphedema Symptom Intensity and Distress Scale: Trunk and Arm) will be reduced after     10 sessions with the Flexitouch® System.      H4: Functional assessment scores (as measured by the Functional Assessment Screening     Questionnaire [FASQ] will improve after 10 sessions with the Flexitouch® System.      Part Two: BCS with Arm Lymphedema H1: Arm volume (as measured by bioelectrical impedance &     arm girth in cm) will be significantly reduced after one month of home use in participants     using the Flexitouch® System (truncal, chest, and arm compression) when compared to those     using the Flexitouch® System (arm compression only).      H2: Truncal measurements/volume (as measured circumferentially) will be less after one month     of home use with the Flexitouch® System (truncal, chest, and arm compression) when compared     to those using the Flexitouch® System (arm compression only).      H3: The number, severity, and intensity, of physical and psychological symptoms (as measured     by Lymphedema Symptom Intensity and Distress Scale - Arm ) will be significantly reduced     after one month of home use with the Flexitouch® System (truncal, chest, and arm garments)     when compared to individuals using the Flexitouch® System (arm compression only) .      H4: Functional assessment scores (as measured by the FASQ) will be significantly higher after     one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when     compared to individuals using the Flexitouch® System (arm compression only).   "
231297|NCT00880035|"     Major objective: a three-days interventional cross-over trial [one day music on, one day     wash-out, one day music off][two periods of listening/day], to evaluate:        1. Impact on sedative drug consumption.        2. Alteration of stress neuropeptide blood concentrations.      Population: mechanically-ventilated ICU patients      The investigators hypothesize the music will decrease the need of sedative drugs and reduce     the concentration of neuropeptides in circulation.   "
231282|NCT00879840|"     Background:        -  Endometrial and ovarian cancers are, respectively, the fourth and eighth most common          cancers among women in the United States. Although some routine Pap tests may detect the          presence of cancer cells, there are no convincing early detection approaches for either          cancer. Better methods of detection are needed.        -  Two possible methods for cancer detection involve samples taken with a tampon or a          special kind of brush, called a Tao brush. Researchers would like to know more about how          well these methods work.      Objectives:        -  To assess the quality of DNA collected by the tampon and Tao brush sampling methods.        -  To detect genetic markers in collected DNA and determine if these markers are related to          an individual s cancer status.      Eligibility:        -  Women age 45 years and older with confirmed or suspected endometrial or ovarian cancer,          who will be having surgery.        -  A control group of postmenopausal women having surgery for benign gynecological          conditions will be included.      Design:        -  Shortly before hysterectomy or more extensive procedures to treat either cancer or the          benign condition:        -  A tampon will be inserted into the vagina to collect cell samples, and removed after 30          minutes.        -  After the tampon is removed, the cervix will be swabbed with the Tao brush to collect          cell samples.        -  Following the hysterectomy, samples of healthy and cancerous tissue will be taken, and          tested by researchers.   "
231283|NCT00879853|"     The enormous global burden of mental illness has been estimated through the publication of     the Global Burden of Disease Study, adding momentum to refugee mental health studies (1,2).     As research confirms that high levels of Posttraumatic Stress Disorder (PTSD) and depression     occur in post-conflict settings, it is essential to develop effective treatment for     psychological trauma in refugee populations recovering from mass violence (3-4). PTSD and     depression are risk factors for anger, interpersonal discord and violence, not only among     those who have trauma and depression, but also among their spouses and children (5-9). This     infectious model of trauma/violence is critically important in the setting of ethnic     conflict, as increased levels of interpersonal violence within the afflicted community hinder     its recovery and fuel future cycles of conflict. To date, there has been little research on     the interpersonal effects of trauma among refugee populations. The proposed research is a     pilot and randomized controlled trial of Interpersonal Therapy (IPT) for Sudanese refugees     living in Cairo. IPT, a very effective therapy for depression, has been adapted for PTSD     treatment and sub-Saharan Africa settings (10-12). Measures will evaluate success of the     treatment not only in terms of individual PTSD and depression symptoms, but also with respect     to interpersonal conflict. Hypotheses: (1) After IPT intervention, Sudanese refugees will     have lower levels of depression and trauma symptoms compared to wait list controls (2) After     IPT intervention, Sudanese refugees will have lower levels of interpersonal violence compared     to wait list controls.   "
231284|NCT00879866|"     Primary trial objective in this single arm trial is to assess the safety and tolerability of     Selectikine (EMD 521873) given in combination with and local tumor irradiation and to     determine whether the maximum tolerated dose (MTD) is reached with EMD 521873 doses of up to     0.45 mg/kg.      Secondary objectives are to evaluate PK, immunogenicity, overall response, changes in tumor     marker levels and circulating tumor cell numbers, progression-free survival and overall     survival. Also, to evaluate biological/immune responses to EMD 521873.      NSCLC patients have to be stable (PR or SD) after first-line chemotherapy in order to be     enrolled. A total of 12 to 24 patients are planned. Patients will remain on the dose     throughout the trial. It is intended to administer at least 4 cycles (21 d each), or until     progression or 2nd line therapy becomes necessary.   "
231285|NCT00879879|"     RATIONALE: Losartan may be effective in treating patients with idiopathic pulmonary fibrosis.      PURPOSE: This clinical trial is studying the side effects of losartan and to see how well it     works in treating patients with idiopathic pulmonary fibrosis.   "
231286|NCT00879892|"     The main purpose of this study is to explore whether xenon is neuroprotective in humans. In     addition, the purpose is to explore the underlying mechanisms for the possible synergistic     neuroprotective interaction of xenon and hypothermia in patients suffering cerebral ischemia     post cardiac arrest, by undertaking brain imaging to evaluate their effects on cerebral     hypoxia, neuronal loss and mitochondrial dysfunction. In addition, the investigators aim to     correlate these findings with neurological outcome to determine surrogate markers of     favourable clinical outcome at six months.   "
231287|NCT00879905|"     This study will study the safety, tolerability and metabolism of a drug called HSP990 when     given by mouth once a week or twice weekly to subjects with advanced solid tumors.   "
231289|NCT00879931|"     Hypothesis: Corticoid treatment in cardiac surgery works renal protective.      Study design: Randomized, double blind trial in which one group of patients will receive     methylprednisolone and the other group (control) will receive placebo NaCl 0.9%.   "
231290|NCT00879944|"     The object of this research study is to examine these associations in children as very little     is known about psoriasis and cardiovascular risk factors in the pediatric population.   "
231291|NCT00879957|"     Background: Heparin is an anticoagulant commonly used in the neonatal population as a means     to prevent catheter related occlusion and malfunction by thrombosis (clot). Given the recent     overdoses of infants using heparin, there is concern as to whether heparin should be used in     peripherally inserted central venous catheters (PICC). Scientific evidence comparing the     duration of use of heparin versus no heparin in PICCs is conflicting.      Purpose: The purpose of this study is to evaluate the effect of continuous IV fluids with     heparin versus IV fluids without heparin on the duration of percutaneously inserted central     venous catheters (PICC) in neonates.      Design: Prospective, double-blind, randomized controlled trial Hypothesis: The use of heparin     in PICC fluids has no difference on duration of catheter patency.      Design and Methods: The study will be conducted at the Neonatal Intensive Care Unit at     University Hospital, San Antonio, TX. Randomization to either the experimental group     (no-heparin) or the standard medical group (with heparin) will occur once parental consent is     obtained and prior to PICC insertion. PICC placement will be done by the PICC certified     neonatal nurses. Correct placement of the PICC will be assured by radiography which is     standard procedure.      Parents, NICU team members and staff, and investigators will be masked to the grouping.     Pharmacy will be responsible for randomization. Both the heparin group and the no heparin     group solutions will be dispensed in identical containers, compounded by the pharmacy.      The study medication, heparin, will be mixed by the pharmacy at a standard dose of 0.5     units/mL for the intravenous infusions used in the heparin group. The experimental group will     receive only the base solution, whether it is 5% dextrose, 0.9% sodium chloride, or total     parenteral nutrition infused into the PICC line. Pharmacy and the NICU staff will ensure     compatibility of heparin with other infusions. Heparin bonded catheters, heparin flushes, and     hep-lock solutions are not used by the NICU service.      The primary outcome, duration of catheter use, is defined as the time (in hours) between     insertion and removal of the catheter due to occlusion. Occlusion will be defined as the     inability to push 1 mL of 0.9% sodium chloride, via a 5 mL syringe, through the catheter in     situ or detection of clots along the catheter after removal.      Secondary outcomes include septicemia vs. catheter-related septicemia, phlebitis, death     before discharge, and thrombosis. Septicemia is identified as clinical signs and symptoms     associated with sepsis in the presence of a positive peripheral blood culture obtained     irrespective of the catheter tip culture result. Catheter-related sepsis will be defined as     positive blood culture obtained from the catheter fluid as well as a positive blood culture     obtained from a peripheral venous specimen. Both cultures must demonstrate the same organism.     Phlebitis is defined by visual detection, swelling, and change of skin color associated with     an inflamed vein. Thrombosis is defined as a thrombus along catheter path diagnosed by visual     inspection upon removal of the catheter. Elective versus non-elective removal will also be     recorded.      Adverse events monitored include: heparin induced thrombocytopenia (HIT), defined as a     platelet count dropping below 50 x 103/mL with a positive antibody titer, aPTT > 100 seconds     (This will be measured upon clinical evidence of bleeding), hemorrhage from > 2 sites,     intraventricular hemorrhage, extravasation, and dislodgement or breakage of catheter.      The sample size will be determined based on retrospective data collection to reach a     statistical power of 80% with a type I error or 0.05. The investigators expect the sample     size to be approximately 102 patients in each arm of the study.      The study will terminate once the PICC is discontinued or if there is an indication to stop     the study early for safety reasons. These could include increased adverse events in one group     versus the other. A Safety Control Panel composed of 2 neonatologists from another site will     review the data at the points when 1/3 and then 2/3 of total patient enrollment has been     achieved.      Data Collection and Analysis: Data will be collected and tabulated on a Microsoft Excel     spreadsheet using unique patient identifiers and stored at a secure location at UHS then     analyzed using appropriate statistical tests.   "
231293|NCT00879983|"     The purpose of this study is to estimate the pharmacokinetics and evaluate the safety     following a single dose of azithromycin 2g extended-release powder for oral suspension with a     3-day dosing regimen of azithromycin 500mg tablet in Chinese healthy male subjects. This     study data will be used to support azithromycin NDA in China.   "
231294|NCT00879996|"     The purpose of this study is to determine if buprenorphine or methadone is better for the     treatment of chronic pain among patients who have become addicted to prescription narcotics.   "
231295|NCT00880009|"     This is a phase 2 study of bosutinib administered in combination with letrozole versus     letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects     in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28     days. The second part will proceed with subjects receiving a dose that is determined to be     safe based on the safety evaluation of the first part. Eligible subjects will be randomly     assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole     alone for a specified period of time. Subjects will be followed up for survival after study     drug discontinuation.   "
231464|NCT00883246|"     The purpose of the study is to evaluate the intermediate and long-term effectiveness of     stand-alone atherectomy treatment of peripheral arterial disease in the legs.   "
231298|NCT00880048|"     This is a 6-week, randomised, multicenter, double-blind, placebo controlled, fixed dose     parallel group study to assess the efficacy and safety of orvepitant (30 and 60 mg/day)     versus placebo in subjects with a diagnosis of a Major Depressive Disorder, whose symptoms     are considered moderate or severe.      Following an initial screening visit, subjects fulfilling the study inclusion and exclusion     criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory     and ECG assessments and to confirm eligibility for inclusion into the study. This screening     phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the     screening period, eligible subjects will be randomised at the baseline visit to receive     either orvepitant 30mg/day, orvepitant 60mg/day or placebo (equal chance of receiving any of     the three possible treatments, i.e., a 1:1:1 ratio) for a six-week double-blind treatment     phase. Those subjects randomised to receive placebo will receive study medication identical     in appearance to that received by subjects assigned to receive orvepitant 30 or 60mg/day.      Efficacy will be assessed via standard depression symptom and severity rating scales or     questionaires. The Hamilton Depression Rating Scale (HAM-D) will be used as the primary     measure. Secondary efficacy endpoints include the Quick Inventory of Depressive     Symptomatology (QIDS-SR) and the Clinical Global Impression- Global Improvement and Severity     of Illness Scale (CGI-I and CGI-S, respectively).      Safety will be assessed by monitoring for adverse events (side effects) and through periodic     laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart     rate, temperature) and heart function measurements (electrocardiograms, or ECGs).   "
231299|NCT00880061|"     Background:        -  Diffusely infiltrating pontine glioma (DIPG) or supratentorial high-grade glioma (HGG)          are brain tumors that are often difficult to treat. It is very difficult to get          chemotherapy agents to tumors in the brain, and researchers are looking for new methods          to directly treat these types of cancer.        -  IL-13 is an immune molecule normally occurring in the body. Patients with gliomas appear          to have significant amounts of the IL-13 receptors in their brain tumors. An          experimental drug, IL13-PE38QQR, combines a bacteria toxin with human IL-13 to allow the          toxin to enter and destroy the tumor cell. Early clinical studies suggest this treatment          may prolong survival of patients with these types of brain tumors.        -  A technique called convection-enhanced delivery (CED) uses continuous pressure to push          large molecules through the membranes protecting the brain to reach brain tumors. This          technique can treat a tumor more directly than with traditional methods.      Objectives:        -  To test the safety and feasibility of giving IL13-PE38QQR directly into regions of the          brain in pediatric patients with DIPG or HGG, using CED.        -  To determine the most appropriate dose of IL13-PE38QQR to treat DIPG or HGG.        -  To determine the effects of this experimental therapy on the tumor.        -  To evaluate the physical changes in the tumor before and after the therapy.      Eligibility:        -  Patients who are less than 18 years of age and have been diagnosed with either DIPG or          with supratentorial HGG that has not responded well to standard treatments.      Design:        -  Patients will be admitted to the hospital and will receive a magnetic resonance imaging          (MRI) scan to show the exact location of the tumor. A small plastic tube will be          inserted surgically into the tumor area, and IL13-PE38QQR and a MRI contrast agent          (gadolinium DTPA) will be infused into the area.        -  MRI scans will monitor the process, and the tube will be removed after surgery.        -  Doses will be adjusted over the course of the study.        -  Patients who respond well to treatment may be eligible to receive a second infusion, no          sooner than 4 weeks after the first treatment.        -  Post-treatment visits:      Clinic visits 4 and 8 weeks after the treatment, and then every 8 weeks for up to 1 year.        -  Physical examination with neurological testing, an MRI, and standard blood and urine          tests.   "
231300|NCT00880074|"     The goal of this clinical research study is to learn if an imaging solution,     [F-18]-fluoro-L-thymidine (FLT), when used with a positron emission tomography (PET) scan,     can help doctors to better see changes in the growth of tumors in the body. Researchers want     to learn if FLT-PET scans can show an early response to chemotherapy.   "
231301|NCT00880087|"     Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in     which the body's temperature is lowered and maintained several degrees below normal for a     period of time, has been used to successfully treat adults who have experienced cardiac     arrest. This study will evaluate the efficacy of therapeutic hypothermia at increasing     survival rates and reducing the risk of brain injury in infants and children who experience a     cardiac arrest while in the hospital.   "
231302|NCT00880100|"     Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of     Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption     in CF children with pancreatic insufficiency (PI). This study is sponsored by Aptalis Pharma     (formerly Axcan).   "
231303|NCT00880113|"     Less than 10% of all ischemic stroke patients are treated by intravenous thrombolysis (IVT)     as most present later than the accepted 3 hour time window. Intra-arterial thrombolysis (IAT)     is possible 3-6 hours post ictus, but is infrequently used. Mechanical thrombectomy (MT) with     a MERCI device is a new intervention possibility but lacks large randomized studies. Although     it is desirable to treat more stroke patients, clinical information and plain CT alone are     insufficient to discriminate which patients are most likely to benefit or be harmed from     treatment. Advanced imaging techniques can help predict patient outcome and provide the     necessary information to weigh expected benefit against associated risk of treatment.     Visualizing the penumbra, the hypoperfused tissue at risk of infarction around the     irreversible infarct core, is one way of identifying patients most likely to benefit from     intervention. Magnetic resonance imaging (MRI) based selection of patients with sufficient     penumbra for thrombolysis is possible, however, MR has less 24-hour availability than CT in     the acute setting. Plain CT is mostly used to exclude intracerebral hemorrhage, and can     easily be extended with CT perfusion (CTP) and CT angiography (CTA). CTP compares well to MRI     for imaging penumbra and infarct core, and it is faster and more feasible than MRI. Other     image findings such as infarct core size and leakage of the blood-brain-barrier     (permeability) on CTP, and site and extent of the occlusion and collateral circulation on CTA     also influence stroke outcome but have not been combined in one study to assess their     combined predictive value.      Hypothesis:      The investigators hypothesize that combined CTP and CTA parameters can predict patient     outcome in acute ischemic stroke.   "
231304|NCT00880126|"     The effects of using Community Development Teams to increase the number of counties that     successfully implement and sustain Multidimensional Treatment Foster Care programs is studied     in a randomized trial in 40 California counties. MTFC is an alternative to group or     residential placement for youth with severe conduct and emotional problems referred from the     juvenile justice and child welfare systems.   "
231316|NCT00880282|"     This phase I trial is studying the side effects and best dose of cixutumumab when given     together with temsirolimus in treating younger patients with solid tumors that have recurred     or not responded to treatment. Monoclonal antibodies, such as cixutumumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
231305|NCT00880139|"     There is much evidence that localized low grade inflammatory processes may contribute to the     microvascular complications of type 1 and type 2 diabetes mellitus including     sight-threatening diabetic retinopathy. Some biomarkers for inflammation have been found to     be elevated in diabetes patients and correlations between those biomarkers and the severity     of diabetic complications have been found in the last years. The relation between this low     grade inflammation and the microvascular changes observed in diabetic retinopathy is,     however, not well characterized.      In the present study patients with different stages of non-proliferative diabetic retinopathy     will be included. Several markers of inflammation will be measured from blood samples. These     markers will be related to vascular factors including flicker-induced vasodilatation as a     marker of endothelial dysfunction and perifoveal leukocyte velocity and density as measured     with the blue field entoptic phenomenon. In addition, the ophthalmologic status of the     patients will be assessed according to the Modified Airlie House classification.      A multiple regression model will be employed to study the association between the different     methods.   "
231306|NCT00880152|"     PTSD is a common consequence of war, for soldiers and civilians. PTSD results in     hyperarousal, avoidance, numbing, and re-experiencing, causing persistent decreased quality     of life. Mindfulness involves the ability to bring attention to the present moment without     judgment; this ability is correlated with measures of mental health. Within health care,     mindfulness is taught as an 8-week course called Mindfulness-Based Stress Reduction (MBSR).     MBSR is unstudied for PTSD. We propose to assess the feasibility of MBSR as an intervention     for PTSD, since it may affect hypervigilance, avoidance, and reactivity associated with this     disorder.      Specific Aims: Aim 1: Assess the feasibility of recruiting and retaining a sample of veterans     with PTSD to complete a study protocol that involves randomization to usual care or usual     care plus MBSR. Aim 2: Apply measures of PTSD symptom severity, depression and quality of     life before and after randomization, to assess whether there is evidence of benefit and     whether MBSR warrants further study for PTSD, and allow calculation of standardized effect     sizes. Aim 3: Apply a validated measure of mindfulness before and after treatment. Aim 4:     Explore the relationship between PTSD symptoms, mindfulness score, and frequency of     meditation practice.   "
231307|NCT00880165|"     This research study is comparing home and in-laboratory testing of veterans with suspected     obstructive sleep apnea, a common breathing disorder during sleep. It is hoped that home     testing will be equally effective in improving quality of life but have lower cost than     in-lab testing. These findings will allow veterans to have greater access to diagnosis and     treatment of their sleep apnea.   "
231308|NCT00880178|"     Coronary heart disease (CHD) is a serious health concern that affects millions of people in     the United States. It is usually caused by atherosclerosis—a condition that occurs when fatty     material and plaque build up on the walls of the arteries that supply blood and oxygen to the     heart, causing the arteries to narrow. As the arteries narrow, blood flow to the heart can     slow down or stop, which can cause chest pain, shortness of breath, heart attack, or heart     failure. Another component of CHD events involves inflammatory changes that result in     structural breakdown of atherosclerotic plaques. Adding niacin to statin medications may be     an effective way to block inflammation in the atherosclerotic plaques. This study will     examine magnetic resonance imaging (MRI) images and blood samples of participants in the     AIM-HIGH study who are taking niacin plus statins or statins alone to determine the effect of     these medications on inflammation in atherosclerotic plaques.   "
231309|NCT00880191|"     RATIONALE: Gabapentin may prevent or reduce delayed nausea and vomiting caused by     chemotherapy. It is not yet known whether gabapentin is more effective than a placebo in     preventing nausea and vomiting.      PURPOSE: This randomized phase III trial is studying the side effects of gabapentin and to     see how well it works compared with a placebo in preventing nausea and vomiting in patients     receiving chemotherapy.   "
231310|NCT00880204|"     The aim of the proposed study is to determine if specific training in management of general,     obstetric, neonatal and pediatric emergencies results in a change in practice of doctors     working in emergency departments of public sector hospitals in three districts of Pakistan.     The overall goal of the proposed study is to test the ability of a standard course (5-days     training) to promote the provision of effective and evidence based practices in public sector     hospital settings.   "
252601|NCT01162395|"     The main purpose of the study is to investigate the safety and tolerability of AZD3514 when     given orally to patients with castration-resistant prostate cancer (CRPC)   "
231313|NCT00880243|"     The purpose of this study is:        1. To compare priming with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) during          induction and consolidation courses versus no priming.        2. To compare as consolidation timed sequential chemotherapy versus four courses of high          dose cytarabine.   "
231314|NCT00880256|"     Irritable bowel syndrome (IBS) is a very common, chronic disorder that significantly affects     quality of life, and results in enormous expenditures each year in the United States. Therapy     for IBS is generally unsatisfactory, and takes an additive approach whereby medications are     prescribed according to each type of symptom the patient experiences. Accumulating evidence     indicates that persons with IBS have a heightened perception of stress, and chronic stress     has been shown to have a significant impact on IBS symptomatology. Mindfulness involves the     ability to bring attention to the present moment without judgment; this ability is correlated     with measures of mental health and decreased stress perception. The clinical literature     suggests that mindfulness-based interventions may lead to improvement in many disorders     including chronic pain, stress, anxiety, eating disorders and depressive relapse. The purpose     of this study is to collect survey pilot data to determine whether an 8-week program of     mindfulness-based stress reduction (MBSR) improves symptoms and quality of life for persons     with IBS. Patients in the 8-week MBSR program are referred as part of their clinical care,     and we seek approval only to collect survey data before and after the MBSR course. This study     will evaluate whether there is sufficient evidence of efficacy to warrant a full clinical     trial of MBSR.   "
231315|NCT00880269|"     This study was to evaluate the efficacy and safety of single agent oral panobinostat in     patients who have refractory de novo or refractory secondary AML.   "
231853|NCT00881530|"     The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2     different doses compared to Metformin or to Sitagliptin given for 78 weeks in different     modalities of treatment in patients with type 2 diabetes mellitus.   "
231317|NCT00880295|"     Although some surgeons prefer one technique rather than the other, both endoscopic and open     carpal tunnel release procedures are accepted as standard of care surgeries to relieve carpal     tunnel syndrome. The investigator's research is designed to evaluate the significant     difference in patient satisfaction between endoscopically-released wrists and open-released     wrists. The goal of the study is to compare the two techniques using the following criteria:        1. Primary outcome: patient satisfaction via surveys used in prior publications        2. Secondary outcome: length of time to return to work        3. Secondary outcome: clinical data for recovery from carpal tunnel syndrome including a          thorough physical exam and EMG's        4. Secondary outcome: complication rates   "
231318|NCT00880308|"     This first-in-human dose-escalation study is to characterize the safety, tolerability,     pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in     patients with advanced solid tumors.   "
231319|NCT00880321|"     BRF112680 is a first-time-in-human study to establish the recommended dose and schedule of     the orally administered GSK2118436. The recommended dose and regimen will be selected based     on the safety, pharmacokinetic, and pharmacodynamic profiles observed after the treatment of     subjects with solid tumors. This is a two-part study. Part 1 will identify the recommended     Part 2 dose using a dose-escalation procedure. Escalation may proceed until either a maximum     tolerated dose is established, or the toxicokinetic safety limit is reached. The recommended     Part 2 dose will be expanded to up to 12 patients. Part 2 will explore further the safety,     tolerability, and clinical activity of GSK2118436 in subjects with BRAF mutation-positive     tumors. In addition, the effect of GSK2118436 on midazolam will be assessed in a subset of     patients in Part 2. Biologically active doses will be identified by measurement of     pharmacodynamic markers in tumor tissue and blood across a range of doses and these doses may     be explored in Part 2.   "
231320|NCT00880334|"     In this research study the investigators are looking to see if the combination of docetaxel     plus Vandetanib is effective in the treatment of metastatic transitional cell carcinoma     (TCC). Docetaxel is a chemotherapy drug that kills cancer cells that are dividing. It is     widely used in TCC. Vandetanib is a drug that is believed to stop new blood vessels from     forming around cancer cells. The combination of docetaxel and Vandetanib has been studied in     people with lung cancer and found to be helpful in killing cancer cells. Thus, this study is     looking at people with TCC, to see if the combination of docetaxel plus Vandetanib is better     or worse then docetaxel alone.   "
231321|NCT00880347|"     The objective of the study is to define the performance of blood-based signatures for     Alzheimer's Disease (AD) in different patients populations including AD, non-AD dementia, and     non-demented controls.   "
231322|NCT00880360|"     This study tests whether denileukin diftitox will deplete regulatory T cells, boost     tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or     who are ineligible for front line therapy.   "
231323|NCT00880373|"     The use of oral ibuprofen combined with Opioid (Morphine or Diamorphine) administered through     patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in     adults with sickle cell disease (SCD).   "
231324|NCT00880386|"     RATIONALE: Losartan potassium may be effective in treating pulmonary fibrosis caused by     radiation therapy in patients with non-small cell lung cancer.      PURPOSE: This clinical trial is studying losartan to see how well it works in treating     pulmonary fibrosis caused by radiation therapy in patients with stage I, stage II, or stage     III non-small cell lung cancer.   "
231335|NCT00880542|"     RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as ifosfamide, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving sorafenib together with     ifosfamide may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with     ifosfamide and to see how well it works in treating patients with high-grade soft tissue     sarcoma or bone sarcoma that can be removed by surgery.   "
252668|NCT01163266|"     The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD),     compared with placebo in adults with major depressive disorder.   "
231325|NCT00880399|"     This is a 6-week, randomised, multicenter, double-blind, placebo controlled, fixed dose     parallel group study to assess the efficacy and safety of orvepitant (30 and 60 mg/day)     versus placebo in subjects with a diagnosis of a Major Depressive Disorder, whose symptoms     are considered moderate or severe.      Following an initial screening visit, subjects fulfilling the study inclusion and exclusion     criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory     and ECG assessments and to confirm eligibility for inclusion into the study. This screening     phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the     screening period, eligible subjects will be randomised at the baseline visit to receive     either orvepitant 30mg/day, orvepitant 60mg/day or placebo (equal chance of receiving any of     the three possible treatments, i.e., a 1:1:1 ratio) for a six-week double-blind treatment     phase. Those subjects randomised to receive placebo will receive study medication identical     in appearance to that received by subjects assigned to receive orvepitant 30 or 60mg/day.      Efficacy will be assessed via standard depression symptom and severity rating scales or     questionaires. The Hamilton Depression Rating Scale (HAM-D) will be used as the primary     measure. Secondary efficacy endpoints include the Quick Inventory of Depressive     Symptomatology (QIDS-SR) and the Clinical Global Impression- Global Improvement and Severity     of Illness Scale (CGI-I and CGI-S, respectively).      Safety will be assessed by monitoring for adverse events (side effects) and through periodic     laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart     rate, temperature) and heart function measurements (electrocardiograms, or ECGs).   "
231326|NCT00880412|"     The objective of this 3-month study is to assess the safety and efficacy of EHT 0202 in     addition to acetylcholinesterase inhibitor in patients suffering from Alzheimer's Disease.   "
231327|NCT00880425|"     The objective of this study is to determine if patients with chronic daily headache have     continuous headache or moments of headache relief. The secondary objective of this study is     to determine the period of time patients who have chronic daily headache that is not     continuous are headache free.   "
231328|NCT00880451|"     The protocol objectives are to enable prospective IRB review of research using human MRI     scans and data collected under other branch protocols or extramural sources. By combining     data from multiple sources the investigators will be able to conduct analyses that require     large numbers of observations that exceed the numbers collected in any single study. They     will also be able to stratify and subgroup the combined samples in different ways to permit     analyses that would otherwise not be possible. The study population consists of normal     individuals and clinical groups of all ages. Clinical groups will be added by amendment     including patients suffering from schizophrenia, ADHD, autism, Klinefelter's disease, and     Alzheimer's disease. The study design consists of 1) automated segmentation of MRI brain     scans to obtain regional measurements of cortical thickness and volumetric measurements of     brain structures including basal ganglia, 2) manual segmentation of brain structures and     brain anomalies not amenable to automated segmentation such as Virchow-Robbins spaces, 3)     correlation analyses between MRI brain measurements and available demographic (e.g. gender)     and physiological (e.g. BMI) data, statistical analysis of group differences where the groups     are defined by diagnosis, age, gender or by other potentially useful classification. Since     all data were collected under other protocols there are no additional risks or benefits     associated with this protocol. This protocol combines MRI data from disparate sources and can     provide important information regarding factors that may affect the comparability of MRI     scans obtained from different sites using various types of MRI scanners and pulse sequences     to generate MRI images. It will also enable the analysis of specific subgroups with     sufficient numbers of observations for meaningful statistics....   "
231329|NCT00880464|"     The purpose of this trial is to test the safety of a vaccine made from a patient's own breast     cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The     vaccine is made by genetically modifying a patient's own tumor cells to secrete     granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response   "
231330|NCT00880477|"     This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's     DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV     according to a three-dose immunisation course and as a booster dose in infants born to     hepatitis B antigen seronegative mothers and previously primed with a birth dose of GSK's HBV     vaccine.   "
231331|NCT00880490|"     The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 compared to     placebo and Formoterol Fumarate (Foradil Aerolizer) in patients with moderate to severe     chronic obstructive pulmonary disease (COPD).   "
231332|NCT00880503|"     Background:      Resistance to cancer chemotherapy develops in patients, rendering certain treatments     ineffective. Despite much research, the prevailing cause of drug resistance is not known.      One mechanism for drug resistance involves a protein called P-glycoprotein, or Pgp, which     reduces the effectiveness of cancer treatments by pumping anti-cancer drugs out of tumor     cells where they are supposed to work against the disease.      Objectives:      To identify and evaluate more thoroughly the roles of Pgp and other substances in mediating     drug resistance.      Eligibility:      Patients enrolled in clinical trials of cancer therapies at the Children's Hospital of     Pittsburgh; Cancer Centers of Carolinas; Arizona Clinical Research Center; University of     Copenhagen; and Herlev Hospital, Copenhagen who have consented to the use of blood, tissue,     or tumor samples for laboratory studies.      Design:      Blood, tumor, and tissue samples are collected from participants and sent to the NCI for     various laboratory analyses.   "
231333|NCT00880516|"     The purpose of this study is to learn more about the genetics of chronic sinusitis and     identify genes involved in chronic sinusitis.   "
231334|NCT00880529|"     The purpose of this study is to find out if patients having the ON-Q post-op Pain Relief     System for pain management of multiple rib fractures will require fewer ventilator days, and     will need less IV pain medicine to control their pain, and as a result have improved     respiratory function during their recovery.      The standard of care for providing pain relief for rib fractures is to use an opioid drug     that is injected into the vein but also has side effects. Increased doses can lead to over     sedation and consequently lead to difficulty with breathing. The ON-Q pain relief systems     uses a local anesthetic under the skin. The anesthetic is called bupivicaine, and it is     delivered from a thin tube approximately 10 inches long is tunneled under the skin along the     back and parallel to the spine. The medication is stored in an elastic pump which delivers a     slow continuous drip of medication from multiple holes in the tubing. Subjects will be     randomized to either standard intravenous opioid pain management or the ON-Q pain relief     device with supplemental opioid medication if needed. The device will remain in use until the     subjects are able to breathe without the ventilator.   "
233538|NCT00914212|"     This study will determine whether BOLD-fMRI can be used to probe hunger and satiety states in     healthy overweight or obese men and also whether fasted/fed fMRI signals can be modulated by     sibutramine.   "
231336|NCT00880555|"     Alzheimer's disease (AD) often manifests as a memory disorder before dementia develops.     Dementia is considered to be present when a person can no longer handle complex activities of     daily living, such as managing finances. This study will investigate the relationship between     changes in the ability to manage finances and brain perfusion, which will be measured using     continuous arterial spin-labeling (an experimental MRI). Subjects will also undergo     neuropsychological tests focusing on several types of memory and thought process, with     special emphasis on semantic memory. An important question to be addressed is whether changes     in function are better predicted by the neuropsychological tests or by the brain scan.   "
231337|NCT00880568|"     This study determines recommended clinical dose, to evaluate the safety, tolerability and     pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors     who have failed standard therapy or for whom no standard therapy exists, in two dosing     schedules in Japan.   "
231338|NCT00880581|"     To assess the feasibility of using intra-tumoral PF-3512676 in combination with local     radiation as a therapy for lowgrade b-cell lymphoma.   "
231339|NCT00880594|"     Individuals with irritable bowel syndrome (IBS) may experience abdominal pain as a result of     pain signals in the bowel and how these signals are processed in the brain. Studies using     brain imaging (pictures) have shown that IBS patients with more pain diagnoses (i.e.     fibromyalgia, migraines, etc.) have greater activity in the regions of the brain responsible     for the emotional and thought processing of pain signals. This could possibly make bowel     sensations and bowel difficulties feel abnormal or more noticeable, in turn causing more     severe IBS symptoms. The purpose of this protocol is to explore the role of pain diagnoses     and their affect on brain activity in IBS patients. The investigators will also examine the     use of a medication, desipramine, which is known to affect these brain regions, in IBS     patients.   "
231344|NCT00880659|"     The next influenza pandemic is expected to spread rapidly in resource-poor settings.     Influenza viruses spread from human-to-human via large respiratory droplets. Transmission via     large-particle respiratory droplets is believed to be mediated by close contact between     infected and susceptible persons or contact with droplet-contaminated fomites. Close contact     between infected and susceptible persons may consist of skin-to-skin contact (e.g., via     hands) or inhalation of respiratory droplets (e.g., due to talking, coughing, or sneezing by     the infected person). Airborne transmission, which is expected to result in transmission over     long distances (>1 meter) and which would be mediated by ventilation, is believed to be     uncommon. Therefore, the greatest risk of transmission from personal contact comes from those     people who are closest to an index case, such as contacts living in the same household. There     are, to date, no published estimates of the secondary attack ratio of influenza among     household contacts of index case-patients in low-income countries. Moreover, the     investigators do not have data on the risk factors for secondary transmission of influenza     from index case-patients to their household contacts. There is some data for the benefits of     promoting handwashing with soap on the risk of all-cause acute respiratory illness among     children < 15 years old in a resource-poor setting in Pakistan. But, the investigators do not     have evidence that promoting handwashing with soap will acutely reduce the risk of secondary     transmission. Therefore, the investigators propose to conduct a study in rural Bangladesh to     assess the following:        -  The secondary attack ratio of influenza among household contacts of an index          case-patient with influenza        -  The risk factors for secondary transmission of influenza from an index case-patient to          household contacts        -  The impact of promoting handwashing with soap on the risk of secondary transmission of          influenza from an index case-patient to household contacts        -  The impact of handwashing promotion on handwashing behavior six months after          intervention        -  The impact of handwashing promotion on the prevalence of respiratory infections,          diarrhea and influenza   "
231345|NCT00880672|"     The purpose of this study is to determine whether dutasteride may influence the expression of     angiogenesis factors such as hypoxia inducible factor (HIF)-1alpha and vascular endothelial     growth factor (VEGF) in patients with lower urinary tract symptoms/benign prostatic     hyperplasia (LUTS/BPH).   "
231346|NCT00880685|"     The goal of the proposed study is to evaluate the efficacy and safety of memantine in     kleptomania.   "
231347|NCT00880698|"     Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting     for 45% of severe diarrhea disease in both developed and developing countries. Annually,     rotavirus causes approximately 111 million episodes of gastroenteritis requiring home care,     25 million clinic visits, 2 million hospitalizations, and approximately 440,000 deaths in     children less than 5 years of age, of which approximately 90% of hospitalizations and 99% of     deaths occur in developing countries. Although rotavirus infection is not more common in     HIV-infected children, it complicates their care and interferes with their nutrition. Chances     of death by these infections can be greater in HIV-infected children when they also suffer     from wasting, malnutrition, and/or opportunistic infections. The primary purpose of this     study was to evaluate the safety and immunogenicity of the Rotavirus vaccine candidate,     RotaTeq, in HIV-infected and uninfected children born to HIV-infected mothers.   "
231348|NCT00880711|"     The purpose is to collect real life data on the use of fulvestrant in normal clinical     practice in Austria and document the clinical benefit of fulvestrant treatment.   "
231349|NCT00880724|"     The objective of this randomized, blinded, multicenter, controlled study is to compare the     performance of the IBV Valve System (treatment group) to a control group receiving a sham     bronchoscopy procedure without valve placement.   "
231395|NCT00881023|"     The Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment     of damaged knee cartilage using the subject's own healthy cartilage obtained from a     non-weight or low weight-bearing region. CAIS is indicated for the repair of articular     cartilage lesions and osteochondritis dissecans (OCD) of the knee through cartilage     regeneration.   "
231397|NCT00881049|"     This study is a single-armed, open-label, single-center phase II trial of signal transduction     inhibitor number 571 (STI-571) systemic therapy in selective patients with metastatic     melanoma, and aims to study the efficacy and safety. The primary endpoint is progression-free     survival (PFS) and the second endpoints are overall response rate (ORR), overall survival     (OS), 1-year OS and safety.   "
231350|NCT00880737|"     The objectives of the PROTECT study are:        -  To assess the role of CT pulmonary angiography in the risk stratification of          hemodynamically stable patients with acute symptomatic pulmonary embolism (PE).        -  To assess the role of transthoracic echocardiography in the risk stratification of          hemodynamically stable patients with acute symptomatic PE.        -  To assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk          stratification of hemodynamically stable patients with acute symptomatic PE.        -  To assess the role of the Pulmonary Embolism Severity Index (PESI) in the risk          stratification of hemodynamically stable patients with acute symptomatic PE.        -  To assess the combined role of CT pulmonary angiography, transthoracic echocardiography,          PESI, troponin I and brain natriuretic peptide in the risk stratification of          hemodynamically stable patients with acute symptomatic PE.   "
231351|NCT00880750|"     This study is being conducted to assess any potential differences in the absorption and     excretion between two lanthanum carbonate formulations. This study is also being done to     assess the safety and tolerability of the two lanthanum carbonate formulations.   "
231352|NCT00880763|"     The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with     Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C     infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid     viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in     the placebo group, when each is administered concomitantly with pegylated interferon     (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated     compared with placebo, when each is administered concomitantly with peg-IFN α-2a and     ribavirin for 28 days.   "
231353|NCT00880789|"     With this study, we want to see if we can use a kind of white blood cell called T cells to     prevent or treat AdV and CMV infection. We will grow these T cells from the cord blood before     the patients transplant. These cells have been trained to attack adenovirus/CMV-infected     cells and are called Adenoviral/CMV-specific cytotoxic (killer) T-cells or AdV/CMV-CTL. We     would plan to give the patient one dose of AdV/CMV-CTL any time from 30 days after their     transplant. We have used T cells made in this way from the blood of donors to prevent     infections in patients who are getting a bone marrow or blood stem cell transplant but this     will be the first time we make them from cord blood.   "
231366|NCT00875121|"     This study examines the effects of increasing the cost of social interactions and food on     overweight and non-overweight youth. Using a computerized operant task youth will earn points     exchangeable for food and social activity.      The investigators predict that both overweight and non-overweight children will substitute     food for interactions with an unfamiliar peer when this alternative is made expensive. Also,     the investigators predict that both overweight and lean participants will defend their choice     to spend time with a friend even when this alternative is made expensive.   "
231354|NCT00880802|"     Study Objectives      The following items will be prospectively assessed.      Primary Endpoints        1. For patients presenting with clinical suspicion of Acute Coronary Syndromes (ACS), high          sensitivity-cardiac Troponin I (hs-cTnI) provides improved diagnostic accuracy for ACS          (including Acute Myocardial Infarction (AMI) and/or Unstable Angina (UA)) within the          first two (2) hours after emergency department presentation when compared to currently          available troponin assays.        2. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved          prognostic information with regard to 180 day event rates of Major Adverse Cardiac Event          outcomes, including cardiac deaths which are defined as all deaths except those that are          clearly non-cardiac in nature (e.g. trauma), when compared to a currently available          troponin assay.      Secondary Endpoints        1. For patients presenting with clinical suspicion of ACS, using the rate of rise of          hs-cTnI over time between presentation and 2 hours (delta hs-cTnI) allows for the          differentiation between ACS and other disease states.        2. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved          sensitivity for detecting AMI within the first two (2) hours after presentation when          compared to a currently available troponin assay.        3. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved          negative predictive value for ruling out ACS (AMI or UA) within the first 2 hours after          presentation when compared to a currently available troponin assay.        4. For alternative endpoints of cardiac mortality, and for alternative censor time points          of 30 days, 90 days, and 1 year, hs-cTnI provides improved prognostic information when          compared to the currently available troponin assay.        5. In cases where the emergency physician has limited diagnostic confidence, hs-cTnI AMI          diagnostic accuracy will be superior to local hospital standards for AMI determination.        6. In cases where the emergency physician has limited diagnostic confidence, the slope for          the hs-cTnI between presentation and 2 hours will add diagnostic accuracy for ACS          diagnosis over and above local hospital standards for ACS determination.        7. For patients presenting with clinical suspicion of ACS, the difference in diagnostic          accuracy for ACS (including AMI and/or UA) using hs-cTnI measurement from time of onset          of symptoms to emergency department presentation (e.g. 3 hours instead of 6 hours) will          be evaluated to assess any variation.   "
231355|NCT00880815|"     The goal of this clinical research study is to learn if bendamustine, when given with a stem     cell transplant and chemotherapy (fludarabine and rituximab), can help the transplanted stem     cells start to grow and make new blood cells in patients with leukemia and lymphoma. The     safety of this combination will also be studied.   "
231356|NCT00880828|"     The primary objective of the study is to investigate the efficacy of device with far-infrared     (FIR) irradiation in these patients with acute cervical radiculopathy.   "
231357|NCT00880841|"     A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg     Buprenorphine/Naloxone.      NIDA Contract No. HHSN271200577414C   "
231358|NCT00880854|"     The purpose of this study is to find out the highest safe dose of the investigational drug     CP-675,206 when given in combination with BCG therapy to patients who have experienced     recurrent superficial bladder cancer after standard BCG treatment.      In addition, the study will look to see if taking CP 675,206 generates an immune response and     evaluate how the drug affects superficial bladder cancer.   "
231359|NCT00880867|"     The primary objective of this study is to evaluate the safety of intratumoral     Polyinosinicpolycytidylic acid stabilized with polylysine and carboxymethylcellulose     (poly-ICLC)(Hiltonol®) in addition to low-dose local radiotherapy for adult patients with low     grade lymphomas, including follicular lymphoma, marginal zone lymphoma, small lymphocytic     lymphoma, chronic lymphocytic leukemia, and cutaneous T-cell lymphoma. The secondary     endpoints are response rate, immune responses, and durability of responses as well as     generation of antiinflammatory response at sites of tumor involvement.   "
231360|NCT00880880|"     The overall goal of this study is to test whether an electronic pelvic floor questionnaire     (e-PAQ-PF) will increase discussion rates of incontinence in a primary care setting.   "
231361|NCT00880893|"     Primary Objectives:        -  To evaluate safety after each CYD Dengue vaccination.        -  To evaluate the immune response to each CYD Dengue serotype after each vaccination in a          subset of subjects.   "
231362|NCT00880906|"     This study is for patients who have had a food impaction and/or difficulty swallowing, who     are scheduled to have endoscopy, biopsy and possibly dilatation (stretching) of the     esophagus.      Standard treatment for people who have food impaction and difficulty swallowing is endoscopy     to view the esophagus, tissue biopsies of the lining of the esophagus for diagnosis, and drug     therapy including steroids and drugs used to treat reflux disease. Early dilatation or     stretching of the esophagus may be done at this time but not always. Some doctors prefer to     wait and see if the drugs are affective.      It is not known if dilating the esophagus early in treatment adds benefit. Therefore, we are     doing this study to compare the two methods of treatment. We will compare two groups: one     group will have dilatation performed during the first endoscopy and one group will not have     dilatation performed during endoscopy. We will see if dilatation helps prevent food impaction     and improves swallowing.      Another purpose of this study is to learn more about the causes of swallowing problems, thus     extra biopsies will be taken of the esophagus and store them for future research.   "
231363|NCT00880919|"     The Primary objective of this study is to evaluate Seroquel XR in the treatment of borderline     personality disorder (BPD). As in many initial randomized control trials, the study will be     of relatively short duration - 8 weeks - to assess effectiveness and safety while maximizing     retention. The specific aim is to determine if Seroquel XR is superior to placebo. The     primary outcome measure will be a statistically significant difference between Seroquel XR     compared to placebo on the Zanarini Rating Scale for Borderline Personality Disorder     (ZAN-BPD), an objective rating scale that addresses the severity of Diagnostic and     Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of the illness. As     there is the recent development of an extended release form of Seroquel (Seroquel XR) (Schulz     et al. 2007), the new compound may offer several advantages in this study. Therefore, the     hypothesis of this study is that both doses of Seroquel XR (see below) will be superior to     placebo in an 8-week randomized trial as assessed by the ZAN-BPD.      To achieve the Primary Objective of this study, two doses of Seroquel XR will be tested - 150     mg/d and 300 mg/d. Thus, the study will be able to assess the effect of Seroquel XR compared     to placebo and to explore a dose effect.   "
231364|NCT00875095|"     The purpose of this study is to establish a new criteria with which to judge the quality of     sperm samples submitted for artificial reproductive treatments. It is believed that this type     of testing can compliment the traditional semen analysis to better drive patient care.   "
231365|NCT00875108|"     Follow-on study to the VIAject™-08J study to evaluate the long-term safety and efficacy of     VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 2     diabetes mellitus.      The VIAject™-08J study is the efficacy and safety study for insulin VIAject™ to demonstrate     equivalent blood glucose control in patients with type 2 diabetes mellitus with VIAject™     insulin or regular human insulin as prandial insulin and to demonstrate an equivalent safety     profile for VIAject™ in comparison to human insulin.   "
231367|NCT00875134|"     This study is designed to test the ability of a computer-based algorithm to detect and     intervene in cases of narcotic-induced respiratory depression.   "
231368|NCT00875147|"     Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative     outcome after resection of colorectal liver metastases.   "
231369|NCT00875160|"     This is an open-label study designed to assess if AT2101 is safe in patients with Gaucher     disease and how AT2101 gets through the body after it is taken by mouth. The study is being     offered to adult patients with type 1 Gaucher disease who are currently receiving a stable     dose of enzyme replacement therapy (ERT) with imiglucerase. During the study, subjects will     not be receiving ERT (up to 35 days).      The study consists of a screening period (~14 days), a treatment period (12 days) and a     follow-up period (7 days after last dose). At two points in the study, subjects will be     housed in an in-patient treatment facility for 3 days/2 nights to accommodate all necessary     blood draws.   "
231370|NCT00875173|"     Background:      Chagasic myocardiopathy caused by the protozoa Trypanosoma cruzi has been the principal cause     of cardiac death in Latin America. Without any trypanocidal therapeutic intervention,     infected subjects can pass from the indeterminate to the cardiac form with heart dysfunction.     Our group has studied the role and the effect of the supplementation with the essential     micronutrient selenium (Se) on T. cruzi infection, and the investigators have verified that:        1. low Se levels is related to the severity of the myocardiopathy in chagasic patients        2. adequate Se diet is essential for mice survival at the acute phase of the experimental          T. cruzi infection        3. Se supplementation prevented the myocardial lesions at the acute phase in mice. From          these findings and considering that Se supplementation was able to prevent Keshan          cardiopathy, to revert electrocardiographic and echocardiographic alterations in          patients nourished by parenteral route, and reduced re-infarction and cardiac deaths          from acute myocardial infarction; the investigators purpose to investigate if Se          treatment via oral route, is able to impair the progress of heart dysfunction in          chagasic patients expressed by the study of progression rate and by the comparison of          the means of ventricular ejection fraction.      Methods:      The Selenium treatment and Chagasic Cardiopathy (STCC) trial is double-blind, placebo     controlled, randomized in 130 chagasic patients at the chronic phase following the inclusion     criteria of (a) altered ECHO (LVEF between 0,35 % and 45 %), (b) age between 20 and 65 years,     (c) randomly divided in two groups: Placebo (n=65) and Se (n=65). Patients of Se group will     intake diary 100 µg Se as sodium selenite for 12 months. The primary endpoint is the     reduction of 50 % in the progression rate of heart dysfunction, and the secondary endpoint is     a partial or total reversion in electrocardiography alterations.      Conclusion:      This trial was recently approved by Brazilian Research Ethics Committee and will be conducted     in accordance with the principles for human experimentation. If the investigators confirmed     the benefit of Se treatment, a strategy of utilization a micronutrient in an adequate     concentration as a treatment in diary diet can revolutionize the therapeutic for chagasic     myocardiopathy.   "
231371|NCT00875186|"     The aim of this study was to assess the efficiency of aerobic physical exercise (APE) on     weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y     Gastric bypass (RYGBP).   "
231372|NCT00875199|"     This study is designed to evaluate the feasibility and provide preliminary evidence for     efficacy of a 12-week contingency management intervention to promote weight loss in     overweight and obese low income adults in a community-based clinic. The study has three     primary goals: (a) to determine if the contingency management treatment can be effectively     applied to a new application, weight loss; (b) to obtain preliminary evidence for contingency     management's efficacy in promoting weight loss and improving treatment retention, diet     quality, physical activity levels, and self efficacy; and (c) to identify barriers and     challenges to implementing contingency management for weight loss among low income patients.   "
231396|NCT00881036|"     Individuals with resolved hepatitis B, characterized as hepatitis B surface antigen     (HBsAg)-negative and hepatitis B core antibody-positive, have latent hepatitis B virus (HBV)     infection in their liver tissue. Cytotoxic chemotherapy and hematopoietic stem cell     transplantation sometimes trigger the reactivation of latently infected HBV, resulting in de     novo hepatitis B. Although de novo hepatitis B could cause acute liver failure or chronic     hepatitis, an effective management strategy for de novo hepatitis B has not been well     established. Risk factors and effective management for de novo hepatitis B will be clarified.   "
231398|NCT00881062|"     This study was to determine the ADME and metabolites of Proellex following a single oral dose     of 25 mg.   "
231373|NCT00875212|"     The aim of this study was to investigate the buffering effect of a calcium     glycerophosphate-fluoride (CaGP-F) dentifrice on in vivo dental biofilm after a cariogenic     challenge and evaluate its probable 12-hour protective effect. Twelve young adults took part     in this randomized, double blind, 14-day 4-phase crossover study. Between each phase, the     volunteers had a 1-week wash-out period. Coded dentifrices were randomly assigned to the     volunteers: A) no F and no CaGP; B) CaGP-only (0.13%); C) F-only (1500 ppm (ppm= parts per     million of fluoride which is equivalent to mg/kg)); D) CaGP-F (0.13%, 1500 ppm,     respectively). The pH measurements were taken from a single-site using a microelectrode, with     salt bridge established by a 1M KCl (one molar potassium chloride) solution with a reference     electrode. pH measurements were taken at 0 (baseline), 1, 7, 14 and 21 min (minutes) after a     cariogenic challenge (10% w/v sucrose solution, %w/v = percent weight per volume). Four sets     of measurements were carried out: (D0BS) before test dentifrice usage; (D01min) 1-min after     test dentifrice usage; and (D712h) 7 days and (D1412h) 14 days using the test dentifrice, 12     hours (h)after brushing. Stephen curves and mean AUC (area under the curve) were obtained.   "
231374|NCT00875225|"     The purpose of this study is to test an interactive DVD intervention to encourage patients to     stick to their blood pressure medication in order to achieve blood pressure control for     African American patients. The intervention will convey health messages through personal     patient stories who have dealt with or continue to struggle with high blood pressure.      Hypothesis 1: At the end of 9 months a higher proportion of patients randomized to the     intervention group will achieve appropriate blood pressure control.      Hypothesis 2: At the end of 9 months a higher proportion of patients who randomized to the     intervention group will report high adherence to their hypertension medications.   "
231375|NCT00875238|"     RATIONALE: Studying samples of blood and tissue in the laboratory from women receiving     doxorubicin and trastuzumab for breast cancer may help doctors learn more about changes that     occur in DNA and identify biomarkers for increased risk of cardiac effects.      PURPOSE: This clinical trial is studying side effects involving the heart in women with     breast cancer receiving doxorubicin and trastuzumab.   "
231401|NCT00881101|"     The purpose of this study is to determine the maximum tolerated dose and dose limiting     toxicities of liposomal paclitaxel in Chinese patients with solid tumors in advanced stages.   "
231474|NCT00883376|"     Introduction: Obstructive sleep apnea syndrome (OSAS) became an important and prevalent     illness in recent years. The population occidental becomes fat each time, and this symptom is     associated the biggest risk for the OSAS. Snore presence is extremely associated with OSAS.     Snoring is present in about 90 - 95% of the patients with OSAS.      Objectives: Evaluate the influence in the Stanford classification as predictor factor of     gravity of the OSAS.      Materials and Methods: They evaluated and classified 107 patients, Classification of     Mallampati, Friedman, Classification of Stanford and how much the gravity of the OSAS for the     AIH.   "
231376|NCT00875251|"     Growth is traditionally used as a prognostic measure after admission to a neonatal intensive     care unit (NICU). Quality of neonatal intensive care is one of the factors determining the     health and quality of life for those that survive, with the principal objective of increasing     disability-free survival. Nowadays, there is some researches showing us that these preterm     babies present a different body composition when they achieve term age compared with babies     birth at term and this condition could be putting these babies in risk to metabolic syndrome     early in adult age. The majority of infants born between 24 and 29 weeks of gestational age     fail to achieve the mean birth weight for fetuses of the same gestational age, and many weigh     below the 10th percentile at hospital discharge. The focus of this study is the growth and     body composition of very low birth weight infants growing in the extrauterine environment.     The central question is, when they reach the corresponding term weight, is the body     composition of newborns growing outside of the uterus different from that of infants growing     in the intrauterine environment? The investigators are also trying to validate 3 different     methods to research body composition: DXA, air-displacement plethysmography and electric     bioimpedance.   "
231377|NCT00875264|"     The primary objective of this study is to determine the maximum tolerated dose (MTD) and     dose-limiting toxicities of CEP-11981 in patients with advanced, relapsed/refractory solid     tumors.   "
231378|NCT00875277|"     The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its     combination with calcipotriol and betamethasone using a psoriasis plaque test method.   "
231379|NCT00875290|"     The purpose of this study is to see if the use of a real-time glucose sensor improves     diabetes control in young children (less than 4 years old) with Type I diabetes when they are     initiated on insulin pump therapy.   "
231380|NCT00875303|"     Play Nicely, is a 40 minute, interactive, media-rich, CD ROM that teaches parents, health     care professionals, counselors, and child care workers/teachers the basics in aggression     management for children ages 1-7. For more information about the program and to review     results of previous studies, see www.playnicely.org. The objective of this study is to     determine if using this brief intervention during the well child visit can affect parents'     plans to discipline their children.   "
231381|NCT00875316|"     Phytopharm plc is developing Cogane™ which is a new medicine for the treatment of Parkinson's     disease (PD). The purpose of the study is to find out if Cogane is safe and well tolerated in     both healthy volunteers and Parkinson's disease patients and to determine if there is a     difference in the way that the body deals with Cogane (pharmacokinetics) between these two     groups.      It is expected that the study will prove that Cogane™ is safe and well tolerated and will     provide us with a pharmacokinetic profile for both subject groups.   "
231382|NCT00875329|"     Goal: The ultimate goal of this research program is to improve the health and quality of life     for wounded warriors from Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) through     screening, risk assessment, and outcome measurement.      Purpose: The purpose of this study is to evaluate the reliability and validity of the     existing Traumatic Brain Injury (TBI) Clinical Reminder Screen for OEF/OIF Veterans.   "
231392|NCT00880984|"     Purpose:      Evaluation of the CAR™ 27 for the creation of compression anastomoses.      Indication:      Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during     colonic or colorectal resection.      Study Design:      Prospective, open labeled study.      Patient Population:      Male or female subjects 18 years of age or older who are scheduled for non emergency     laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy     can be preformed up to the discretion of the surgeon.      No. of Subjects:      15 patients estimated up to three months to enroll.      Duration of Treatment:      During the operation - creation of the anastomosis.      Duration of Follow-up:      Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic     visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone     after 3 months.      Endpoints:      To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse     events related to the use of the CAR™ 27 device.   "
231393|NCT00880997|"     Doxazosin, an alpha 1-adrenergic receptor, may play an important role in cocaine addiction in     humans. This study will evaluate the effectiveness of doxazosin in preventing drug relapse     among cocaine dependent participants.   "
231383|NCT00875342|"     This study proposes to evaluate the effects of D-cycloserine (DCS) combined with     cognitive-behavioral treatment with exposure therapy in a sample of patients who developed     posttraumatic stress disorder (PTSD) as a consequence of various traumas (e.g., motor vehicle     and accidents, burns and other injuries, combat, World Trade Center attack, etc.). In     addition, this study hopes to determine whether a common human genetic single nucleotide     polymorphism (SNP) in a growth factor, brain derived neurotrophic factor, BDNF SNP     (Val66Met), predicts treatment response to PTSD.      Patients living in areas that are not geographically proximal to the Weill-Cornell Medical     Center New York City campus will receive cognitive behavioral therapy using telemedicine     (videoconferencing technology).      Overall, this study aims 1) to determine if subjects administered DCS show a significantly     larger decrease in symptoms of PTSD as compared to those administered a placebo, 2) to     determine if subjects administered DCS show a decrease in PTSD symptomatology significantly     earlier (as measured by weeks) than those administered a placebo, 3) to determine if     differences in symptomatology are evident at a 6-month follow-up and indicate long-term     differences between groups, 4) to determine if the BDNF SNP predicts treatment response, 5)to     determine if it is feasible and acceptable to provide imaginal exposure (IE) therapy for PTSD     using videoconferencing technology.   "
231384|NCT00875355|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. It is not yet known whether     radiation therapy is more effective when given alone or together with temozolomide in     treating brain metastases secondary to breast cancer.      PURPOSE: This randomized phase II trial is studying how well radiation therapy given together     with temozolomide works compared with radiation therapy given alone in treating women with     brain metastases and breast cancer.   "
231854|NCT00881543|"     The purpose of this study is to demonstrate the secretion of glucose, insulin, glucagon,     C-peptide and lipid profile after isocaloric diets with different nutritional compounds (fat,     protein and carbohydrate food) in drug näive tipo 2 patients.   "
231385|NCT00875368|"     Rationale: Improving cellular immunity by means of increasing CD4 cells is one of the goals     of antiretroviral therapy in HIV, which is achieved by means of virological suppression. A     certain group of patients, the so called immunologic non responders, fail to reach an     acceptable CD4 cell increase despite an adequate virologic response on antiretroviral     treatment. Recently a new antiretroviral agent, maraviroc (Celsentry®), is registered for the     treatment of patients infected with CCR5 tropic HIV-1 virus. However, data is available     suggesting that treatment with maraviroc leads to immune recovery (increase in CD4 cells) in     patients who are infected with dual/mixed tropic HIV-1 virus, in the absence of a virologic     response. This suggests an alternative mechanism for immune recovery, which could be     especially beneficial for this group of patients.      Hypothesis: Maraviroc, by a yet unknown mechanism, stimulates immune recovery by increasing     CD4+ cell count.      Objective: The primary objective is to confirm the hypothesis that maraviroc stimulates     immune recovery; the secondary objective is to explore, by virologic and immunologic     investigations, the underlying mechanisms of this hypothesis.      Study design: multicentre, randomized, placebo-controlled, double blind, exploratory     mechanistic study.      Study population: HIV-1 infected patients 18 years or older, who meet the inclusion criteria.      Intervention: One group receives maraviroc (dose dependent on co-medication), the other group     placebo.      Main study parameters/endpoints: A 30% increase in CD4 cell rise in the treatment group     (compared with placebo).      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:        1. In the treatment group subjects will start with a registered antiretroviral agent          (maraviroc).        2. During the treatment year patients will perform several study visits, probably three          more compared with regular visits on the outpatient clinic.        3. Each visit, blood will be drawn by venepuncture for immunologic and virologic          investigations (see flow chart).   "
231386|NCT00875381|"     The purpose of this study is to estimate and define the mean number, degree of confluence,     and depth of penetration of melanocytes in chronically sun exposed skin of the head and neck     using Mart-1 immunostains on frozen sections. The study was conducted to confirm whether     similar results were found using permanent sections. The present study used hematoxaline and     eosin (H&E) staining as well as Mart-1 staining, and included patients from both Mayo Clinic     Jacksonville and Rochester.   "
231387|NCT00875394|"     After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once     daily added to the regimen of patients with inadequate glycemic control on metformin     monotherapy   "
231388|NCT00880932|"     The hypothesis is that a newly formatted electronic alert that requires the prescriber to     pause and enter a specific reason for override on this alert, will cause prescribers in the     intervention group to be significantly less likely to prescribe the combination of warfarin     and NSAID than prescribers in the control group.   "
231389|NCT00880945|"     The aim of this study is to evaluate if Electromagnetic navigation (ENB) in combination with     rapid on site evaluation (ROSE) can improve diagnostic accuracy in those patients who fail to     be diagnosed with conventional fluoroscopic assisted bronchoscopy (FBS) in combination with     ROSE.   "
231390|NCT00880958|"     The purpose of this study is to determine the effect of supplement combined various     probiotics and fermentation products on body mass index, body fat mass, abdominal     circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in     overweight subjects.   "
231391|NCT00880971|"     Several important international randomized trials have shown that postoperative chemotherapy     contributed to the improvement on 5 year survival rate by about 4% for patients with     non-small cell lung cancer after complete resection. But the overall survival rate was     relatively low and the local recurrence was still the dominant failure pattern for stage IIIA     (N2) disease even these patients received the postoperative chemotherapy. Several     meta-analyses have shown that postoperative radiotherapy has no effect on the survival     improvement for patients with non-small lung cancer after complete resection. However,     sub-group analysis based on the same dataset of these meta-analyses showed that the     postoperative radiotherapy with conventional radiotherapy might be beneficial for stage IIIA     (N2) disease. The 3D conform radiotherapy can increase the radiation dose to the target     volume while decreasing the dose to risk organs comparing with the conventional radiotherapy.     So it is expected that postoperative 3D conform radiotherapy after postoperative chemotherapy     will improve the local control and overall survival rate for stage IIIA (N2) non-small cell     lung cancer. Here, the investigators designed a phase III randomized trial to compare the     three years overall and disease free survival rate in patients with completely resected stage     IIIA (N2) non-small cell lung cancer who receive the chemotherapy alone or the chemotherapy     plus 3D conform radiotherapy.   "
231394|NCT00881010|"     The goal of this psychosocial research study is to learn about treating pain and other     symptoms of minority patients who have breast cancer. The study will test how well a special     telephone system works for improving the pain and symptom management of these patients.   "
231441|NCT00882947|"     The purpose of this study is to demonstrate the safety and efficacy of inhaled Iloprost     (Ventavis®) among adult Chinese patients with primary pulmonary hypertension, which is in     compliance with Chinese SFDA regulation.   "
231399|NCT00881075|"     This study will examine the safety and effectiveness of a manganese-based agent called     SeeMore (EVP 1001-1 Injection) for enhancing magnetic resonance imaging (MRI) in patients who     have previously had a heart attack. It will determine whether SeeMore makes it easier to find     damaged areas of the heart and will evaluate how well patients feel and how their bodies     react after receiving the study medication.      Adult patients who have previously had a heart attack and are in stable health may be     eligible for this study. Candidates are screened with a medical history, a brief physical     examination and blood and urine tests.      Participants undergo the following procedures:        -  Collection of blood and urine samples 24 hours before receiving SeeMore and 24 hours          after. A blood sample is also taken 3 and 10 days after receiving the drug.        -  MRI scans one hour before receiving SeeMore and 10 minutes after receiving the drug. MRI          uses a magnetic field and radio waves to produce images of body tissues and organs.          After the first (baseline) MRI is done, SeeMore is given intravenously (through a vein)          and the subject's vital signs and electrocardiogram (EKG) are monitored for 10 minutes.          Then the second MRI is done to determine whether the study medication makes it easier to          see areas of the heart that were affected by the heart attack.        -  Check of vital signs, EKG and physical examination after the second MRI.   "
231400|NCT00881088|"     Objective:      The purpose of this study is to determine the need for thromboprophylaxis in patients with a     fracture of the lower extremity being treated conservatively in a below-knee plaster cast and     to assess if both of the two tested prophylactic treatments are effective for this     indication.      Hypothesis:      Nadroparine and Fondaparinux are both effective in preventing a thromboembolic event in     patients with a nonsurgical fracture of a lower extremity immobilised in a below-knee plaster     cast.   "
231402|NCT00881114|"     This is a study for patients with head and neck cancer who will be receiving chemotherapy and     radiation therapy for their disease. The purpose of this study is to see if the investigators     can use genetic differences between patients to select the right drug to use with radiation     therapy. This type of genetic testing is called pharmacogenetics.      Currently there are two drugs used to treat head and neck cancer that have provided a benefit     when given with radiation compared to radiation alone in previous studies. These two drugs     are cisplatin and cetuximab (Erbitux).      In this trial, the investigators will test whether genetic differences between patients can     be used to pick which drug they should receive. A recent study that looked back to see how     well patients with head and neck cancer responded to treatment with cisplatin showed that     genetic differences in a few genes were associated with who did and who did not survive their     cancer. The investigators are taking that finding and using it to test patients for these     genetic differences to determine whether they should receive cisplatin or cetuximab. In other     words, the investigators are trying to take what is essentially a flip of the coin choice     between these two drugs, and instead use individual patient's genetic differences to make-and     hopefully improve- this choice.   "
231403|NCT00881127|"     To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine     Hydrochloride 5 mg/120 mg ER tablets under fasting conditions.   "
231404|NCT00881140|"     The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone     on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.   "
231405|NCT00881153|"     The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 250 mg/5     ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.   "
231406|NCT00881166|"     Adult subjects with malignant disease appropriate for treatment with carboplatin/paclitaxel,     carboplatin/etoposide, topotecan, docetaxel or erlotinib according to the standard dosing     regimen will be enrolled in each treatment arm.      Primary objective: Determine the MTD.      Secondary objectives: Response rates, PK, quantify MP-470 on PK of SOC, and collect     pharmacodynamic information. Evaluate the overall safety of MP-470 when co-administered with     specific SOC treatments.   "
231407|NCT00881179|"     To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting     conditions.   "
231408|NCT00881192|"     Since its first introduction in humans in 1962, Intra-Aortic Balloon Pump (IABP) is now the     most commonly used therapeutic option to support failing heart in cardiac surgery. The main     effects of IABP are an increase in diastolic blood pressure and therefore an improvement in     coronary perfusion and a reduction of ventricular after load, thus increasing stroke volume     and cardiac output. IABP-related complications include limb ischemia, bleeding at the site of     IABP insertion, infection, and aortic dissection.      IABP could be used preoperatively, intraoperatively, or postoperatively. However, despite the     wide use of the device, the optimal timing and use of IABP in high-risk patients undergoing     cardiac surgery remains controversial. Time of insertion has been showed to affect hospital     mortality, ranging from 18.8% to 19.6% for preoperative insertion, from 27.6% to 32.3% for     intraoperative insertion, and from 39% to 40.5% for postoperative insertion. Several studies,     randomized and non-randomized, have been conducted to address the impact of preoperative use     of IABP on the outcome, each study including a relative small number of patients. In an     effort to increase the strength of the results, two meta-analysis have been conducted and     published in 2008. The objectives of both were to assess the effect on mortality and     morbidity of using IABP preoperatively in high-risk patients undergoing coronary artery     bypass grafting (CABG). Surprisingly, the meta-analysis from Field and co-workers was     conducted on four randomized controlled trials (for a total of 193 patients included)     published by the same author from the same institution, making the results not conclusive     although favourable toward a beneficial effect of the preoperative use of IABP. Moreover, two     of the randomized trials conducted by Christenson and co-workers and included in the above     mentioned meta-analysis, were excluded from the meta-analysis from Dyub and co-workers     because considered duplicates. Unfortunately, one study by Christenson and co-workers and     included in the meta-analysis from Dyub was conducted on off-pump surgery, introducing     another bias in the criteria of eligibility.      At present it is unclear whether the preoperative use of IABP in high-risk coronary patients     scheduled for CABG operations leads to a better outcome. The experimental hypothesis of the     present randomized, controlled trial (RCT) is that the placement of IABP immediately before     beginning the surgical procedure induces a reduction of major morbidity after the operation.   "
231409|NCT00881205|"     This study evaluated the efficacy and safety of 10 cm² rivastigmine patch vs. placebo in     cognitively impaired Multiple Sclerosis (MS) patients. Primary objective was the assessment     of cognition by the Selective Reminding Test (SRT) -a subtest of the brief repeatable battery     (BRB) - after titration of 4 weeks and maintenance of 12 weeks. This double-blind period was     followed by a 52-week open-label treatment phase to assess long-term safety of rivastigmine     patch in these patients.   "
231442|NCT00882960|"     Goal of the research will be to demonstrate a reduction in reported pain following the     atomization and intra-nasal administration of Fentanyl versus the reduction in pain achieved     from intravenous Fentanyl. It is hypothesized that pain should be reduced following fentanyl     administration using the intra-nasal atomization equal to the intravenous delivery.   "
231410|NCT00881218|"     This is a pilot study to determine whether the drug regadenoson can be used during magnetic     resonance imaging to assess regions of poor blood flow to the heart.      The hypothesis of this study is that a single injection of regadenoson could be used instead     of a standard adenosine infusion to produce coronary vasodilatation and demonstrate     myocardial ischemia during first-pass perfusion cardiac MRI.   "
231411|NCT00881231|"     To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting     conditions.   "
231412|NCT00881244|"     A Phase I open label study of AS1411 in advanced solid tumours. Objectives include     determining the MTD and DLT of AS1411, to determine the PK profile of AS1411 and to obtain     preliminary evidence of clinical and biological responses to AS1411 therapy.   "
231413|NCT00881257|"     The objective of this clinical investigation is to evaluate the safety and efficacy of the     Minnow Medical GRST™ Peripheral Catheter System in the treatment of de novo lesions in the     superficial femoral artery (SFA) or the popliteal artery.   "
231414|NCT00882596|"     The purpose of this national, multi-site study is to determine the safety and effectiveness     of the Contura catheter in breast cancer patients undergoing accelerated partial breast     irradiation.   "
231415|NCT00882609|"     The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CT     scanning to that of conventional bone scanning for detecting cancer that has spread to the     bone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride PET/CT     will lead to improved treatment and patient outcomes.   "
231416|NCT00882622|"     The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on     cardiac function in patients undergoing cardiac surgery compared to control intervention.   "
231417|NCT00882635|"     The purpose of this study is to assess the safety and efficacy of Enoxaparin and     Unfractionated Heparin in St Elevation Myocardial Infarction patients undergoing primary     percutaneous coronary intervention.   "
231418|NCT00882648|"     Previous studies by this team of investigators has determined that male infants are more     likely to display more severe neonatal abstinence syndrome (NAS) as a result of maternal     opioid use during pregnancy (Jansson, 2007)and there is appears to be a gender-related     biologic vulnerability to NAS expression (Jansson, 2009, submitted). The proposed study     explores the relationship between fetal gender and substance abuse treatment outcomes among a     population of women in comprehensive substance abuse treatment to explore the possibility of     a psychosocial vulnerability among drug exposed male fetuses as opposed to female fetuses.     Women in substance abuse treatment are a group at high risk for current exposure to violence,     usually at the hands of significant others, and having a history of sexual abuse as a child,     usually resulting from contact with a male family member. Therefore, they often have     difficult relationships with men. At the Center for Addiction and Pregnancy (CAP), a 2006     study revealed that among a group of 715 pregnant women, reports of the exposure to violence     was very high. Their rates of lifetime abuse ranged from 72.7% for physical abuse to 44.5%     for sexual abuse. Rates of abuse remained high during their current pregnancy, ranging from     20% for physical abuse to 7.1% for sexual abuse (Velez, 2006). The abuse was very often at     the hands of partners or other male family member perpetrators. We hypothesize that women     carrying male fetuses will be less likely to remain complaint in drug treatment or abstinent     from illicit drug use, while women carrying female fetuses may be more likely to remain drug     abstinent and treatment compliant. If supported, this theory has the potential to inform     fetal gender specific treatment for pregnant drug dependent women. Additionally, we seek to     support the previously documented link between male gender and more severe expression of NAS,     and explore the relationship between other maternal prescribed drug use (i.e. psychotropic     medications) and severity of NAS expression.   "
231419|NCT00882661|"     The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of     the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease     at one level between C3 and C7, compared to anterior cervical discectomy and fusion.      The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy     associated with the use of the SECURE-C Cervical Artificial Disc   "
231420|NCT00882674|"     This 2 part study will explore the pharmacodynamic effects of R1507 in breast cancer tumor     cells in female patients with operable breast cancer. In the first part of the study,     patients will receive a single dose of R1507, 16mg/kg iv, on day 1; pre-and post-treatment     (at breast surgery on day 8) breast tissue samples will be obtained for measurement of IGF-1R     expression. If sufficient biological activity is demonstrated, 3 additional cohorts of     patients will be entered into Part 2 of the study, to receive a single dose of 9mg, 3mg/kg or     1mg/kg iv R1507, respectively. The anticipated time on study treatment is < 3 months, and the     target sample size is <100 individuals.   "
231421|NCT00882687|"     The purpose of this study is to determine whether SAR 1118 at three different concentrations,     compared to placebo, is effective in the prevention of the signs and symptoms of allergic     conjunctivitis   "
231422|NCT00882700|"     To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting     conditions.   "
231423|NCT00882713|"     This single arm study will assess the efficacy, safety and tolerability of once monthly     administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis     patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting     dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of     epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to     maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the     target sample size is 200 individuals.   "
231424|NCT00882726|"     The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics     of CNTO 3649 following a single dose in healthy adults and following multiple doses in     patients with Type 2 Diabetes Mellitus.   "
231425|NCT00882739|"     The aim of this study is to determine both safety and effectiveness of three different     loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing     primary angioplasty.   "
231426|NCT00882752|"     The method used for the biopsy analysis may be able to provide important insights into the     complex microbial communities found in the human colon or in complex human infections.     Therefore, this methodology may prove useful to other researchers or physicians.   "
231427|NCT00882765|"     RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving genistein before     surgery may be an effective treatment for pancreatic cancer.      PURPOSE: This randomized phase II trial is studying genistein to see how well it works in     treating patients with pancreatic cancer that can be removed by surgery.   "
231693|NCT00886236|"     The purpose of this research study is to evaluate the drug gabapentin (Neurontin®) for its     ability to reduce postoperative pain, the need for morphine-like pain medication, and the     severity and frequency of postoperative nausea and vomiting in laparoscopic gastric bypass     surgery patients.   "
231428|NCT00882778|"     This study is conducted in Europe and North and South America. The primary aim of this     observational study is to evaluate the frequency and pattern of bleeding episodes in     haemophilia patients receiving preventative treatment with activated recombinant human factor     VII. The secondary aim is to evaluate which patients are selected for this treatment, the     dose and dose intervals used, and the safety of activated recombinant human factor VII when     used as prevention. The study also aims to increase understanding of the unmet medical need     and clinical relevance of preventative treatment in haemophilia patients.   "
231429|NCT00882791|"     Basal cell carcinoma (BCC) is the most common skin cancer in the US and can cause significant     adverse effects.      Mohs micrographic surgery, the treatment of choice for higher risk BCC, allows for removal of     lesions with preservation of healthy tissue. Although the BCC recurrence rate post Mohs     surgery is estimated at 1-2%, recent data is lacking to validate this historical measurement.      Our purpose is to determine the current recurrence rate of BCC after Mohs surgery.   "
231430|NCT00882804|"     This study is being done because we want to learn if hemin can increase the production of     heme oxygenase 1. Heme oxygenase 1 (HO-1) is an enzyme which protects cells from physical,     chemical, and biologic stress. Hemin is produced from red blood cells and is approved by the     Food and Drug Administration for treating acute porphyria, which is an inherited condition     caused by an enzyme deficiency.   "
231431|NCT00882817|"     Treatment in interstitial lung diseases (ILD) is frequently ineffective. Pulmonary     rehabilitation (PR) is an excellent therapeutic option in another chronic lung diseases such     as chronic obstructive pulmonary disease (COPD). This prospective randomized controlled study     aims to evaluate the short and long-term effects of PR in patients with ILD. For this     purpose, 60 ILD patients will be randomly assigned to a PR or a control group.      The investigators hypothesize that PR will improve exercise capacity, increase muscle force,     reduce dyspnea and improve quality of life and daily life activities in ILD patients.   "
231433|NCT00882843|"     In persons with SCI, because of inherent considerations, the use of mechanical stimulation     has not been studied to determine improvement in bone mass. To achieve maximum transmission     of the vibration from a vibrating plate to the lower body, the legs must be extended and the     feet firmly placed against the surface plate of the device. Thus, these logistical     considerations must be addressed to perform this mechanical intervention in persons with SCI.     In those with complete or almost complete motor injury, there is lack of musculoskeletal     function below the level of the lesion, which would prevent rigid straight leg extension and     pressing one's feet against a surface, regardless of the angle of tilt that would permit     adequate transmission of impulse in an able-bodied individual (preliminary data). However, in     one subject with SCI, there was measurable, albeit low level, transmission of vibration with     increasing angles of tilt (preliminary data). Because of the ability to transmit some signal     in an individual with complete SCI, the possibility exists that with forms or mechanical     support/manipulation, greater signal transmission may be possible. The study will be able to     determine the best angle to transmit mechanical vibration through the lower body of SCI     patients.   "
231434|NCT00882856|"     Clozapine-induced sinustachycardia occurs in 25% of patients treated with clozapine and     sustained sinustachycardia might be a risk factor for dilated cardiomyopathy. This     double-blinded cross over placebo controlled study investigate whether 10 mg bisoprolol are     efficient in treating clozapine-induced sinustachycardia measured as heart rate, heart rate     variability, QTc and T-wave morphology.   "
231435|NCT00882869|"     AEG35156 is a second generation antisense which targets XIAP mRNA to lower XIAP levels and     the apoptotic threshold of cancer cells, enhancing their sensitivity to intrinsic death and     chemotherapy. Advanced HCC is an attractive target for AEG35156 since XIAP is highly     expressed in HCC and may prevent cancer cells from undergoing apoptosis. Second generation     antisense molecules are known to accumulate in liver where AEG35156 may down regulate XIAP     protein expression in HCC cells thus promoting their apoptotic death.   "
231436|NCT00882882|"     To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting     conditions.   "
231437|NCT00882895|"     This is a research study testing a new approach to treating high-risk non-Hodgkin's lymphoma     consisting of an autologous hematopoietic (blood) stem cell transplant (using a patient's own     hematopoietic cells) followed by a non-myeloablative allogeneic transplantation (transplant     from another individual).      The investigators hypothesize that the addition of the second non-myeloablative transplant     will improve the chances for long-term control of lymphoma.   "
231438|NCT00882908|"     The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in     combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the     proportion of patients with sustained virologic response at Week 72 (patients with     undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and     at Week 72), compared to the control group receiving PegIFN and RBV in combination with     TMC435-matched placebo.   "
231439|NCT00882921|"     The objective of this study is to evaluate the effect of anti-idursulfase antibodies on     idursulfase safety (measured by infusion related adverse events) between patients who develop     anti-idursulfase antibodies and patients who do not after long-term idursulfase enzyme     replacement therapy (ERT).   "
231440|NCT00882934|"     Placebo-controlled randomized clinical trials (RCT) are the gold standard to provide     applicable evidence for clinical practice. A vast number of RCTs for treatment of several     disorders has shown a mean placebo effect of 30%. Erectile dysfunction (ED) is a high     prevalent disease and its first-line therapy is oral phosphodiesterase type-5 inhibitor     (iPDE5) (i.e., sildenafil, vardenafil and tadalafil). Although the placebo effect in iPDE5     RCT occurred at a rate as high as 50%, in the last decade, with the revolutionary discovery     of effective pharmacotherapy for ED, oral iPDE5 has become one of the most common prescribed     drugs for men. The objective of this study is to evaluate the influence of patients'     awareness on the composition of the therapeutic drug in the outcomes of the oral treatment     for ED.   "
231443|NCT00882973|"     This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II     dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus     gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and     combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced     or metastatic pancreatic cancer.   "
231444|NCT00882986|"     The purpose is to determine whether regular endurance exercise and/or body weight influence     the way our nervous and vascular systems respond during the metabolism of meals.   "
231445|NCT00882999|"     To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12,     16, 20, and 24 weeks compared to placebo.   "
231446|NCT00883012|"     Influenza associated pneumonia causes significant morbidity in young HIV-infected children.     Although annual vaccination against influenza is recommended for HIV infected children, it     has not been implemented as routine care, due to the lack of data on disease burden and     vaccine efficacy.      This study aims at determining the effectiveness of influenza vaccination in HIV infected     children in South Africa.   "
231447|NCT00883025|"     Introduction:      OSAS is an important disease in the actual medic scene. It is important for correlation with     chronic cardiovascular disease that leaves an increase in morbimortality and socioeconomic     disability to patients with apnea.      Objectives:      Determinate the correlation between Friedman Classification and the obstructive sleep apnea     syndrome (OSAS) gravity through AHI (Apnea Hypopnea Index) in patients with OSAS for surgical     indication and evaluation.      Materials and Methods:      The investigators evaluated and classified 84 patients, in the scale of Epworth, Friedman and     how much the gravity of the SAHOS for the AHI.   "
231475|NCT00883389|"     This is a pilot observational study to evaluate subjects with chronic kidney disease     acceptance of an alert device linked to an informational website intended to increase     recognition of chronic kidney disease, and to guide patients and providers to the safe     delivery of care required for this disease. Primary device was a bracelet with the     alternative of a key fob with same information supplied when requested. Patients usage of the     device was evaluated by survey with Likert scale as to whether the device is 0 = not useful,     1 = somewhat useful, 2 = extremely useful   "
231448|NCT00883038|"     The aim of the study is to evaluate the effect of experimental (vegetarian) diet compared to     conventional diet with similar caloric restriction on insulin resistance, body weight and     body composition in type 2 diabetic patients after 3 month diet program and additional 3     month diet program combined with intensive exercise.      Hypothesis: Greater improvement in insulin resistance, greater weight loss without     compromising the body composition (subjects will lose fat preferentially to lean body mass)     and differences in the fatty tissue metabolism will be found in the experimental (vegetarian)     group compared to the control (conventional diet) group despite the similar advise on caloric     restriction in both diets. The differences between the two groups will increase after an     intensive physical exercise program.   "
231449|NCT00883051|"     The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of     COL-144 in treating migraine headache, in order to select a dose or doses for further     evaluation.   "
231450|NCT00883064|"     To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting     Conditions.   "
231451|NCT00883077|"     The purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in     assessment of colonic permeability against conventional sugar absorption test.   "
231452|NCT00883090|"     Congenital deficiency of Factor XIII is an extremely rare hereditary disorder associated with     potentially life-threatening bleeding. This study will evaluate the safety and recommended     (best) amount or level of Factor XIII in a patient's blood. Factor XIII Concentrate (Human)     is given to people whose blood is lacking Factor XIII. Factor XIII Concentrate (Human) works     by assisting your blood in the usual clotting process, thereby preventing bleeding.   "
231453|NCT00883103|"     The purpose of this study is to compare the pain perception between lidocaine and plain     aqueous gel during assessment of postvoid residual volume and the Q-tip test.   "
231454|NCT00883116|"     The primary purpose of this study is to investigate whether administration of ixabepilone     results in superior outcome as assessed by overall survival compared with that achieved with     standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer     that has progressed following first-line chemotherapy.   "
231455|NCT00883129|"     Scleroderma is a rare, long-term autoimmune disease in which normal tissue is replaced with     dense, thick fibrous tissue. Normally, the immune system helps defend the body against     disease and infection. In people with scleroderma, the immune system triggers fibroblast     cells to produce too much of the protein collagen. The extra collagen becomes deposited in     the skin and organs, causing hardening and thickening that is similar to the scarring     process. Although scleroderma most often affects the skin, it also can affect other parts of     the body, including the lungs, and in its most severe forms scleroderma can be     life-threatening. Scleroderma-related interstitial lung disease is one example of a     life-threatening scleroderma condition. In people with symptomatic scleroderma-related     interstitial lung disease, scarring occurs in the delicate lung tissue, compromising lung     function. The purpose of this study is to determine whether people with symptomatic     scleroderma-related interstitial lung disease experience more respiratory benefits from     treatment with a 2-year course of mycophenolate mofetil or treatment with a 1-year course of     oral cyclophosphamide.   "
231456|NCT00883142|"     Individuals with neurological deficiencies such as those who have spinal cord injury, stroke,     traumatic brain injury, Parkinson's disease, and multiple sclerosis often lose their ability     to ambulate over ground. Loss of functional mobility not only impedes everyday life, but may     also affect many systems and organs in the body. The investigators are interested in     obtaining a wide variety of data in order to obtain a better understanding of changes that     occur as a result of receiving Lokomat therapy. The investigators will be studying body     composition, cardiac, pulmonary, endocrine, metabolic, and molecular changes after a 12-week     clinical therapy program.   "
231457|NCT00883155|"     To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets under Fasting     Conditions.   "
231458|NCT00883168|"     The purpose of this study is to determine if the combination of two allergy medications     (formulated azelastine/fluticasone product)is more effective than placebo or either component     medication alone (azelastine or fluticasone).   "
231459|NCT00883181|"     The primary objective was to describe the incidence of febrile neutropenia based on     granulocyte-colony stimulating factor (G-CSF) use (primary, secondary, treatment, or no     usage) in patients receiving myelotoxic chemotherapy.   "
231694|NCT00886249|"     The purpose of this study is to evaluate and compare the depth of focus and visual outcomes     after implantation of the Acrysof IQ SN60WF aspheric intraocular lens (IOL) and the Acrysof     Natural SN60AT spherical IOL.   "
231460|NCT00883194|"     This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel     formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers.     PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours.      The purpose of this study is to investigate the safety (side effects if any occurs)     associated with the single administration of PRF-108 or PRF-110 and evaluate their analgesic     effect in an experimentally induced pain model compared with ropivacaine Solution 0.5% and     Vehicle Gel.   "
231461|NCT00883207|"     The main aim of the project is to develop couple therapy for depression with special interest     in dialogical and narrative processes in therapy. Parenthood, and different psychosocial     phenomena, such as domestic violence, suicidal behaviour and alcohol abuse in relation to the     client's specific depressive state will be analysed. The second main aim of the study is to     analyse the effectiveness couple therapy for depression as a real world study. The good and     poor outcome of different therapy processes will be compared and thus information about     precise change processes will be reached. Owing to the real world setting, the inclusion     criterion is a broad one: a primary diagnosis of depression (F32 and F33 in ICD-10).      The project will be conducted as a multicentre study so that in each centre the included     patients will be randomized into experiment and control groups. The study centres are (1)     Pohjois-Savon sairaanhoitopiiri in Kuopio, (2) Länsi-Pohjan sairaanhoitopiiri in Tornio and     Kemi and (3) HUS/ Jorvin sairaala regional psychiatric polyclinics in Espoo. In each province     the entire adult population has free access to the psychiatric outpatient clinics in their     specific catchment area and thus no selection for the patients is done.   "
231465|NCT00883259|"     Gestational diabetes mellitus (DM) is one of the most frequent complications in pregnant     patients with polycystic ovary syndrome (PCOS) in 20-40% of cases and ~40% of patients with     gestational DM are likely to have underlying polycystic ovarian morphology. A recent     meta-analysis demonstrated a significantly higher risk of developing gestational DM [odds     ratio (OR) 2.94; 95% confidence interval (CI): 1.70-5.08] in the PCOS population.      Metformin is an oral biguanide insulin sensitizer used for treating type-2 DM and recently     introduced to treat PCOS.      At the moment, preliminary data seem to reassure regarding the use of metformin in PCOS     patients showing benefits for maternal and fetal outcomes, without serious adverse events.     Furthermore, well-designed randomized, controlled trials (RCTs) on this issue are lacking,     thus it is not possible to either suggest or advice against the use of metformin during     pregnancy for reducing gestational DM risk. To this regard, PCOS represents an intriguing     model of high-risk patients to evaluate the efficacy of metformin for preventing DM     development.      The present protocol firstly will evaluate the effects of metformin administration in     reducing incidence of gestational DM in high-risk patients, such as pregnant PCOS patients.   "
231466|NCT00883272|"     The purpose of this study is to determine if Femeralle (DT56a) has an effect on the     coagulation system, measured by platelet adhesion and aggregation, of normal and     thrombophilic postmenopausal women.   "
231467|NCT00883285|"     The purpose of this study is to compare the incidence of silent and apparent cerebral     embolism between conventional and minimal-invasive transfemoral aortic valve repair.   "
231468|NCT00883298|"     Primary objective - to determine the 6-month progression free survival (PFS) of adult     patients with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly     temozolomide plus (Avastin) bevacizumab.      Secondary objectives - to determine radiographic response including specialized MRI     sequences, safety and overall survival of adult patients with with recurrent glioblastoma     multiforme/gliosarcoma treated with bi-weekly temozolomide plus bevacizumab (Avastin).     Additionally, tumor DNA (MGMT) analysis as it relates to survival will be evaluated.   "
231469|NCT00883311|"     The purpose of the study is to determine whether the topical application of BRT-FC-83C is     effective in the treatment of mild to moderate atopic dermatitis.   "
231470|NCT00883324|"     Observational study to determine whether the proposed method of fFN specimen collection     without a speculum is substantially equivalent to the approved method with a speculum     examination when obtained at the gestational age of ≥ 24 weeks and ≤ 34, 6 days in     symptomatic women and at the gestational age of ≥ 22 weeks, 0 days and ≤ 30, 6 days in     asymptomatic women. A finding of substantial equivalency would support a modification to the     labeling to allow the collection of specimens for fFN determination with or without a     speculum examination.   "
231471|NCT00883337|"     Primary objective was to assess the effectiveness evaluated by the time to failure of two     doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing     Multiple Sclerosis [MS].      Secondary objectives were:        -  To assess the effect of the two doses in comparison to interferon beta-1a on:             -  Frequency of relapses,             -  Fatigue,             -  Participant's satisfaction with treatment.        -  To evaluate the safety and tolerability of the two doses in comparison to interferon          beta-1a.      The study consisted of a core treatment period with a common end date defined as 48 weeks     after randomization of the last participant, followed by an optional long-term extension     treatment period until teriflunomide is commercially available in accordance with local     regulations.   "
231485|NCT00883519|"     The primary aim of this study is to examine whether adolescent depression and the family     context in which it develops is best treated using an individual adolescent intervention or     an intervention that includes both the adolescent and the parents. This will be accomplished     by conducting a randomized controlled pilot study of Interpersonal Psychotherapy for     Depressed Adolescents (IPT-A) in comparison to Interpersonal Psychotherapy for Depressed     Adolescents and Parents (IPT-AP).   "
231695|NCT00886262|"     The purpose of this study is evaluate the medication vasopressin for its ability to preserve     kidney function in patients undergoing liver transplantation.   "
231472|NCT00883350|"     A large proportion of the adult population in the United States qualifies for weight loss     treatment based on the NIH treatment recommendations, but traditional clinic-based weight     loss treatments have a number of limitations. For example, access to healthcare facilities is     limited among people living in rural communities and people of low socioeconomic status, yet     a disproportionate number of these people would benefit from services. Internet-based weight     loss interventions have been used to deliver services to these populations, but these     e-Health interventions suffer from a number of limitations and produce only modest weight     loss. The limitations associated with internet-based interventions include decreased use of     the internet application over time; patients must logon to the internet to receive treatment     recommendations, yet few patients regularly logon to the application and this negatively     affects treatment outcome. An additional limitation is the quality of self-reported food     intake, exercise, and body weight data that participants enter into the internet application     or report to their online counselor. Self-reported data are associated with error and     accurate data are needed to formulate effective treatment recommendations for participants.     Lastly, most applications rely on asynchronous communications between the patient and the     counselor, and patients do not always receive personalized treatment recommendations in a     reasonable amount of time (1 to 3 days), which limits the extent to which the recommendations     result in behavior change and weight loss.      The purpose of the proposed pilot and feasibility project is to test the efficacy of the     Remote Intervention for Diet and Exercise (RIDE) e-Health application at promoting weight     loss compared to a control condition. The RIDE e-Health application addresses the limitations     of internet-based interventions that are noted above. The application relies on novel     technology to collect near real-time food intake, body weight, and exercise data from     participants while they reside in their free-living environments. These data are transmitted     to the researchers in near real-time: food intake data are collected and transmitted with     camera and Bluetoothenabled cell phones using the Remote Food Photography method that was     developed by this laboratory, body weight data is automatically transmitted daily from a     bathroom scale using the same phones, and accelerometry is used to collect exercise data that     is transmitted via the internet. These data are analyzed and personalized treatment     recommendations are sent to the participant in a timely manner, e.g., every 1 to 3 days,     using the cell phones. The RIDE e-Health application was developed based on learning and     behavioral theory to maximize behavior change and weight loss. The findings of this study     will have significant implications for the affordable delivery of effective weight management     interventions to patients with limited access to health care.   "
231473|NCT00883363|"     Preconditioning in patients treated for elective abdominal aneurysm showed that the rate of     perioperative myocardial infarction could be reduced by 80 %(ARR from 27% to 5%).     Precondition where performed by 10 minutes of clamping of each iliac arteries before clamping     the abdominal aorta. Human studies in cardiac patients have shown promising results with     precondition. Instead of clamping arteries they have all performed the procedure by inflating     a blood pressure cuff above arterial pressure on a arm.      The investigators want to investigate if preconditioning induced by a blood pressure cuff on     a arm can reduce the perioperative rate of myocardial infarction in patients open operated     for ruptured abdominal aortic aneurysm.   "
231476|NCT00883402|"     The trial randomise patients with asymptomatic carotid artery narrowing in whom prompt     physical intervention is thought to be needed, but there there is still substantial     uncertainty shared by patient and doctor about whether surgery or stenting is the more     appropriate choice.      The study is looking at immediate risks (within one month)and at long term benefits   "
231477|NCT00883415|"     This study examines patients with chronic kidney disease-related anemia and measures changes     in the metabolism of the heart using FDG/PET scanning, before and 6 months after their     health-care provider has initiated anemia management therapy with the FDA-approved drug     darbepoetin alfa (Aranesp), which is approved for chronic kidney disease-related anemia. The     investigators hypothesize that the heart has abnormal metabolism with the anemia of chronic     kidney disease but this improves after correction of this anemia with darbepoetin alfa.   "
231478|NCT00883428|"     The purpose of this study is to determine the prevalence of low back and pelvic pain in     Spanish pregnant women. The results should allow for the identification of factors associated     with a greater risk of having it during pregnancy. Once risk factors are identified, other     studies can assess the effectiveness of measures to reduce this pain.   "
231479|NCT00883441|"     This project will provide new insights concerning how to reduce dengue transmission by means     of cost-effective and sustainable implementation strategies of vector control methods.      The research will assess key strategies which deliver new vector control tools with respect     to their cost-effectiveness, acceptability and sustainability in contrasting environments.   "
231480|NCT00883454|"     Estimation of functional liver reserve in patients with hepatocellular carcinoma (HCC) in     cirrhosis is of paramount importance to properly select candidates for surgical resection.     Together with the value of bilirubin, the presence/absence of ascites and esophageal varices,     and the rate of residual liver volume, which are our current parameters to measure functional     liver reserve, the investigators sought to investigate the value of preoperative     cholinesterases (CHE) in predict postoperative adverse outcome after hepatic resection for     HCC.   "
231481|NCT00883467|"     Ischemia reperfusion injury may be reduced by ischemic preconditioning. This projects aims to     show the effects of short and long time ischemic preconditioning (both sequences 3 x 5     minutes) during and after an ischemic period of 20 minutes in healthy subjects by functional     MRI. Ischemia is produces by cuff inflation to a suprasystolic pressure on one tight. Signal     is acquired from calf muscles.      A cross-over design of 4 to 8 study periods is used, 4 different study days with 2 different     MR measurement methods (BOLD imaging and high energy phosphates) are planned.   "
231482|NCT00883480|"     This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung     adenocarcinoma.   "
231483|NCT00883493|"     The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with     quetiapine fumarate in combination with lithium in the treatment of a major depressive     episode in patients with bipolar disorder.   "
231484|NCT00883506|"     To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet under Fasting and     Fed.   "
231486|NCT00883532|"     Pulmonary inflammation plays an important role in the early development of CLD. Postnatal     glucocorticoids have been shown effective in the prevention or treatment of CLD with various     success. However, systemic glucocorticoid therapy often associated with various short term     and long term complications. Therefore, modification of the therapeutic regimen is needed.     Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially     unsuccessful, most likely due to small airways that the inhaled steroid reaching to the     peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the     airway has also shown to be ineffective, possibly due to poor distribution of steroid in the     lungs.      The investigators hypothesize that intratracheal instillation of budesonide, a strong     tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to     the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The     result of our pilot study (Pediatrics, 2008) indicated this high possibility.   "
231487|NCT00883545|"     The purpose of this study is to determine whether women who are offered screening colonoscopy     will be more likely to schedule and complete this procedure if they are given the option of a     woman endoscopist.   "
231488|NCT00883558|"     Insulin lispro is approved by the Food and Drug Administration (FDA) for the treatment of     diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid     to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 combined     with a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be     compared to insulin lispro with respect to absorption and action of insulin.   "
231489|NCT00883571|"     This prospective randomized study included 60 consecutive patients suffering from anal     stenosis in the period from April 2002 to December 2008. They admitted to colorectal surgery     unit, Mansoura university hospital, Egypt. According to the classification proposed by Milson     and Mazier(5), all patients had moderate to severe anal stenosis. There were 43 males and 17     female with a mean age 34 + 5.2 years ranging from 18 up to 63 years.   "
231490|NCT00883584|"     COPD is a lung disease in which the lung is damaged, making it hard to breathe. In COPD, the     airways/tubes that carry air in and out of the lungs are partly obstructed, making it     difficult to get air in and out. COPD gets gradually worse over time. At the moment there is     no cure for COPD. The best way to slow the disease is to stop smoking. Current medications     are used to alleviate shortness of breath and cough, and to treat infections of the lungs     that can worsen COPD.      Institute of Medicinal Molecular Design, Inc. (IMMD), a Japanese Drug Discovery Company is     developing a compound code named IMD-1041. IMD-1041 is an investigational drug, meaning it is     not yet on the market. It is an IKKb inhibitor developed for the treatment of COPD. Unlike     most other medications used for COPD currently, IMD-1041 is in capsule form and needs to be     taken twice a day. It is also unlike all other drugs in use because it treats the underlying     cause of the symptoms.      The purpose of this study is to see if IMD-1041 has the ability to reduce inflammatory     derived symptoms and airway remodelling (changes) by looking at certain changes in chemical     levels in the blood and sputum (phlegm).   "
231523|NCT00884013|"     Do monetary incentives in small independent primary care practices improve the delivery of     preventive services as recommended by U.S. Preventive Services Task Force (USPSTF) guidelines     for cardiovascular health?   "
231491|NCT00883597|"     Sepsis is the most frequent cause of death in critically ill patients in non-coronary care     Intensive Care Units in the developed world. Microcirculatory disturbances are central to the     development of the disorder, leading to organ dysfunction, multi-organ failure and fatal     outcome.      In particular the intestinal microcirculation is impaired early in the course of the disease.     This may result in a breakdown of the gut barrier function with translocation of bacteria and     their toxins into the systemic circulation, thus sustaining a gut derived septic state.     Therefore, the impaired intestinal microcirculation has been suggested to act as the motor     of multiple organ failure in sepsis.      The aim of the project is to evaluate a new diagnostic tool and the impact of Activated     Protein C administration on the intestinal microcirculation in patients with severe sepsis     and compare the findings with septic patients who are not candidates for APC therapy and     healthy patients post bowel surgery using an innovative diagnostic tool (side stream     dark-field imaging, SDF).   "
231492|NCT00883610|"     The purpose of this study is to learn what effect rapid atrial pacing (in patients with dual     chamber pacemakers) will have on the electrocardiogram including the QT Interval. The     investigators are also interested in the differences caused by genes.   "
231493|NCT00883623|"     The treatment with oral melphalan and prednisone has been recommended as standard treatment     of AL amyloidosis but the results are rather disappointing. Another therapeutic option is     pulsed high-dose dexamethasone + melphalan (Mel-Dex) with more encouraging results regarding     the achievement of a faster disease response and higher rates of haematological remission. In     the last 5 - 10 years, promising treatment outcomes after therapy with high-dose melphalan     and autologous stem cell support have been reported by several groups but only highly     selected patients are eligible for this treatment. Lenalidomide has been shown to be     effective in phase II and III trials in MM patients. Because of the relationship to MM,     Lenalidomide is a promising therapeutic option also for patients with AL amyloidosis. The     addition of Lenalidomide to Mel-Dex could improve rate of complete response (CR) and organ     response in patients not eligible for or refused high-dose chemotherapy.   "
231494|NCT00883636|"     The objective of this study is as follows:        -  Perform genetic analysis to define the prevalence of each of the known gene mutations in          an unselected cohort of patients with focal segmental glomerulosclerosis (FSGS)        -  Perform a comprehensive assessment of cardiovascular status to determine the incidence          of any cardiac abnormalities in patients with FSGS        -  Determine if patients with mutations in specific proteins are more likely to have          cardiovascular abnormalities        -  Initiate long-term follow up in all patients to determine whether cardiac prognosis is          related to any specific genetic abnormality   "
231495|NCT00883649|"     The purpose of this study is to determine the effectiveness of a nutritional supplement in     post-menopausal women age 40 or older with moderate to severe dry eyes. This study is being     conducted to determine if signs and symptoms of dry eye will improve with the use of this     nutritional supplement.   "
231496|NCT00883662|"     Mirena is used for long-term in Kazakhstan, and in our observational program we would like to     study patients distribution per indications of Mirena, and also patient compliance within a     year after Mirena insertion. For patients with all approved indications for Mirena use:     contraception, treatment of menorrhagia and protection from endometrial hyperplasia during     estrogen replacement therapy   "
231499|NCT00883701|"     COPD exacerbations are characterized by an excessive accumulation and activation of     inflammatory cells in the airways. It is not known whether this phenomenon represents a risk     for for lung damage via the release in the extracellular environment of potent cytolitic     cellular granular contents such as granzymes and perforin.      The investigators assess the intracellular expression of granzymes and perforin in     neutrophils and large granular lymphocytes (LGL) at the onset of exacerbations compared to     stable disease.      The investigators hypothesize that a greater release of intracellular perforin and granzymes     from neutrophils and LGL into the extracellular environment occur at exacerbations compared     to stable condition and that these changes are more pronounced in COPD patients than in     subjects without COPD who undergo respiratory infection.   "
231500|NCT00883714|"     The study will evaluate the effects of a structured endurance exercise program on the     physical performance, the mood and the complications of patients with hematological     malignancies undergoing a high-dose chemotherapy followed by an allogeneic peripheral blood     stem cell transplantation.   "
231501|NCT00883727|"     This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells     in patients with myocardial infarction.   "
231502|NCT00883740|"     The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in     subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)   "
231503|NCT00883753|"     This study was an extension to study MA21573 [NCT00750880], which was an open label single     arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or     combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in     patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24     week core study, and had at least a moderate European League Against Rheumatism (EULAR)     response, were eligible to enter this long-term extension study, and received tocilizumab 8     mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years,     and the target sample size was > 500 individuals.   "
231504|NCT00883766|"     The aim of this study is to compare two different IVF-stimulation protocols in patients     affected by PCOS: the use of a Gonadotropin-releasing hormone (GnRH) - antagonist starting on     day 1 of controlled ovarian hyperstimulation (COH) versus a standard long agonist protocol;     in order to assess whether it affects the number and quality of Metaphase II (MII) oocytes     while reducing the risk of hyperstimulation. Since PCOS patients are also likely to be     insulin resistant we also aim to evaluate how metformin affects tha IVF stimulation outcome.   "
231535|NCT00884182|"     This study is part of an effort to develop an effective vaccination program in children in     the event of a pandemic.      Study objectives:        -  To describe the safety profiles in the periods following each vaccination in subjects          receiving different vaccination schedule.        -  To describe the immune response after each vaccination in subjects receiving study          vaccine.   "
231505|NCT00883779|"     This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or     placebo, plus platinum-based therapy, as first line treatment in patients with advanced or     recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine     (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1,     followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a     total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on     study treatment is until disease progression, and the target sample size is 100-500     individuals.   "
231506|NCT00883792|"     Colorectal cancer (CRC) is a major burden in western countries. The disease develops from     precursor lesions during a long time-interval. Colonoscopy can detect and remove CRC     precursor lesions and may thus be effective for CRC prevention. Many national and     international health organisations demand evidence from randomised trials to reduce incidence     or mortality of the target disease before advocating population-wide cancer screening.     However, while colonoscopy screening for the prevention of colorectal cancer is established     in the United States and several European countries, no randomised trials exist to quantify     the possible benefit of colonoscopy screening. NordICC is a randomised trial investigating     the effect of colonoscopy on CRC incidence and mortality.      NordICC is a multicentre, randomised trial in Nordic countries, the Netherlands and Poland. A     minimum of 66 000 individuals, age 55-64 years, are drawn randomly from the population     registries in the participating countries. 22 000 are invited for once-only colonoscopy (2:1     randomisation). Expected work-load with 50% compliance will be 11,000 colonoscopies. At the     screening examination, all detected lesions are biopsied and removed whenever possible. The     remaining 44 000 individuals (control group) are not offered any screening examination (care     as usual).The primary study aims are CRC incidence and CRC mortality after 15 years of     follow-up, with an interim analysis after 10 years of follow-up. In an intention-to-treat     approach, a risk reduction of CRC mortality of 25% in the colonoscopy screening group     compared to the control group is expected after 10 years follow-up, estimating 50% compliance     in the screening group.   "
231507|NCT00883805|"     This is a pilot study to compare systemic concentrations of cobalt and chromium in patients     that have previously undergone total hip arthroplasties with ceramic on metal and metal on     metal bearing surfaces.   "
231508|NCT00883818|"     The objective of this prospective study is to determine the incidence of mycoplasma in women     with overactive bladder (OAB) symptoms and whether antibiotic therapy targeting these     organisms is effective.   "
231509|NCT00883831|"     Purpose:      Hemodialysis-dependent patients with an end-stage renal disease (ESRD) suffer from a number     of distressing symptoms, such as pain, poor mental health, fatigue, sleep disturbance and     pruritus. These negatively influence health-related quality of life in ESRD patients, and     some of them result in increased mortality and hospitalization. Acupuncture is a widely     employed treatment on several chronic disease or condition. Adjunctive use of acupuncture     with conventional treatment could be a possible therapeutic option to establish an optimal     care for ESRD patients who experiences co-morbid conditions or complications of hemodialysis.     Due to its non-pharmacologic feature, the effects of acupuncture without involving altered     pharmacokinetics and drug-interactions in hemodialysis patients, might be another strong     point compared to other pharmacological interventions. However, little information is     available for the effects and the safety of acupuncture for symptomatic care of hemodialysis     patients.      Thus, the investigators propose whether acupuncture could be a effective and safe therapeutic     modality for a number of patient-reported symptoms in hemodialysis-dependent patients with     ESRD.   "
232123|NCT00890695|"     The purpose of this study is to determine whether an outpatient-based strategy of short-term,     ready to use supplementary food (RUSF) among moderately malnourished children with acute     infections achieves greater improvement in anthropometric measurements of wasting than usual     diet.   "
231510|NCT00883844|"     Treatment with a nucleoside analogue and subsequent viral decline has shown to partially     restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies     investigating whether the effect of lowering viral load with nucleoside analogue therapy     prior to the initiation of peginterferon results in higher sustained off-treatment responses     showed contradictory findings.      The aim of this study is to investigate sustained off-treatment response to peginterferon     alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide     analogues, thereby lowering viral load   "
231511|NCT00883857|"     The purpose of this study is to evaluate a new monitor that measures cardiac output (amount     of blood pumped by the heart). The system that is being tested in this study, called     Endotracheal Cardiac Output Monitor (ECOM), uses electricity (impedance cardiography) to     measure cardiac output and is not harmful to the patient.      This study will test the accuracy and efficacy of the ECOM system in anesthetized and sedated     patients who, in the normal course of clinical care in the OR or ICU, are having cardiac     output measured. The investigators propose that unlike the standard system for cardiac output     measurement, the ConMed ECOM System should result in a simplified, inexpensive, continuous,     less-invasive, and accurate method of measuring cardiac output. Such a technique could allow     the rapid diagnosis of instability in the cardiovascular system for critically ill patients.   "
231512|NCT00883870|"     This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in     critical limb ischemia.   "
231513|NCT00883883|"     To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml fed     conditions.   "
231514|NCT00883896|"     The primary objective of this study is to assess the safety and efficacy of different dose     regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with     active rheumatoid arthritis who are taking methotrexate.   "
231536|NCT00884195|"     This is a pilot study to evaluate the effect of keeping a 'gratitude journal' on the outcome     of a weight loss program. All the subjects will be enrolled in the Lifesteps weight     management program. The experimental group will maintain a gratitude journal and the control     group will maintain a 'neutral' journal.   "
231537|NCT00884208|"     The purpose of this study is to assess the diagnostic efficacy of the Tinetti Assessment,     Timed up and Go test (TUG) and Gait Speed on predicting fall risk in adults 65 years of age     or greater who are community ambulators.   "
231515|NCT00883909|"     ARI103094 is a follow-up study in adult male subjects who have received investigational     product (either dutasteride or placebo) in the REDUCE Study (REduction by DUasteride of     prostate Cancer Events), ARI40006, A Randomized, Double-Blind, Placebo-Controlled, Parallel     Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once Daily     for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. There are 2 parts to     this REDUCE Follow-Up Study, Part A and Part B:        -  REDUCE Follow-Up Study, Part A, is a 2 year observational study which will follow          eligible subjects for 2 years after completion of the 4 Contact in the REDUCE study.          Eligible subjects for Part A, the 2 Year Observational Study fall into 3 groups as          follows: (1) REDUCE subjects who completed treatment with investigational product          (dutasteride or placebo) through the REDUCE 4 Year study visit [Visit 10], (2) REDUCE          subjects who developed prostate cancer, were withdrawn from investigational product and          participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit [Visit          10P] or (3) REDUCE subjects who were withdrawn from investigational product and          participated in observational phone follow up until the REDUCE 4 Year phone call after          withdrawing from IP (expected Visit 10). The objective of this observational study for          eligible REDUCE subjects is to collect and summarize data on prostate cancer (the          incidence of newly diagnosed prostate cancers and changes in prostate cancer diagnosed          during the REDUCE study) and serious adverse events (SAEs) for 2 years beyond the          prospectively planned 4 year double blind, placebo-controlled study, REDUCE.        -  REDUCE Follow-Up Study, Part B, is for collection of cancer positive prostate biopsy          tissue blocks/slides from subjects who were diagnosed with prostate cancer in the REDUCE          study.   "
231516|NCT00883922|"     Children (ages 0-12) that have heart surgery are often at a high risk of developing     complications and have to be continuously monitored. Part of the routine care at UCLA     includes using a monitor (continuous central venous oxygen saturation-ScvO2) to measure the     amount of oxygen saturation in the tissues (indirectly) during surgery and in the intensive     care unit. However, there is not much data on the use and effectiveness of this monitor in     comparison to other monitors used for children.      The purpose of this study is to further evaluate the effectiveness of the continuous central     venous oxygen saturation (ScvO2) monitor in children and compare it with other monitors     during a heart surgery. This is an observational study and the patients will not undergo any     research specific procedures in the operating room (OR). The investigators will observe and     record de-identified information, such as vital signs (heart rate, blood pressure, etc.), to     evaluate the importance of the monitor. This study will also look at the demographics (age,     gender, diagnosis, etc.) and treatments (type of surgery) received children undergoing heart     surgery to improve quality of care. The investigators will also observe the same parameters     in the ICU. The investigators hypothesized that low central venous saturations are associated     with worse clinical outcomes.   "
231517|NCT00883935|"     The purpose of this study is to compare the amount of GSK1349572 (study drug) in the blood     when given with and without atazanavir/ritonavir or atazanavir and to compare the blood     levels of atazanavir when given with GSK1349572 to historical data for atazanavir.   "
231518|NCT00883948|"     Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions     that occur when there is severe inflammation and increased fluids in both lungs, making it     difficult for the lungs to function properly. Hospital treatment for a person with ALI/ARDS     often includes the use of a breathing machine, or ventilator, until the person is able to     breathe without assistance. Initiating proper nutrition through a feeding tube early in a     person's hospital stay may help to improve recovery, but the optimal timing, composition, and     amount of feeding treatments remain unknown. This study will evaluate whether early or     delayed full-calorie feeding through a feeding tube is more effective in reducing recovery     time and increasing survival rates in people with ALI/ARDS.   "
231519|NCT00883961|"     The study evaluates the effects of a supervised exercise program on the physical performance,     the mood and the complications of therapy in patients undergoing a high-dose chemotherapy     followed by an autologous peripheral blood stem cell transplantation.   "
231520|NCT00883974|"     Immediately following birth, preterm infants face a period of stressful environmental inputs,     which may have negative consequences on early brain development and subsequent     neurobehavioral outcomes. This study aimed to assess the effectiveness of training parents in     reducing stressful experiences early in life. The investigators hypothesized that this     intervention would insulate preterm infants from the harmful effects of acute and chronic     stress, which in turn would result in enhanced brain development. The primary aim of the     current study was to investigate if this intervention was associated with improved brain     development measured by magnetic resonance imaging (MRI) at term-equivalent age. A secondary     aim was to assess some possible short-term medical benefits.   "
231546|NCT00884325|"     It is historically well known that the management of pruritus in atopic dermatitis is very     difficult. Most of the patients are not controlled with traditional antihistamines such as     Clarinex, Claritin, and Allegra. It will be a welcome addition to our treatment armamentarium     if a drug such as Xyzal can control pruritus associated with atopic dermatitis.   "
232124|NCT00890708|"     The purpose of this study is to determine whether therapeutic drug monitoring of voriconazole     is useful in the treatment of invasive fungal infection.   "
231521|NCT00883987|"     Eighty percent of Canadians experience low back pain (LBP) at some point in their life     (Waddell, 1987), with a point prevalence of up to 30 percent (O'Sullivan, 2005; Waddell,     1987). Low back pain has severe economic ramifications. Most incidents of low back pain occur     during the prime working years of life, with an estimated cost to the economy at $14,744     Canadian dollars per person per year (Health Canada, 1998). Indirect costs in the form of     long-term disability were highest for disorders of arthritis and chronic back pain (Health     Canada, 1998). It has been estimated that 12 percent of patients will experience disability     within one year after their first episode of low back pain (Banner, 2006). Evidence based     diagnosis and treatment is important for desirable outcomes.      The investigators predict that there will be changes in A) trunk muscle electromyographic     patterns and in temporo-spatial gait patterns following osteopathic treatment.   "
231522|NCT00884000|"     This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone     deficiency in children. The children will be treated for 1 year. Half of the patients will be     treated with Genotropin and half with Zomacton. During this time they will be dosed every day     by themselves or their parents at home in the evening. There will be 138 patients in the     trial from age 3 to age 11. The patients cannot have been treated before with growth hormone     and the patients must have a proven growth hormone deficiency, this will be shown by a     specific test that will be performed before the trial in the local clinic and once during the     trial. During the time of the treatment the patients will come to visit the clinic every 3     months. At these visits their heights will be measured, blood samples will be taken, physical     examinations will be performed and questions about their health will be asked. At 2 times in     the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial     the patients will stop the treatment and continue on one of the marketed products available     to treat growth hormone deficiency.   "
231524|NCT00884026|"     A fall in blood pressure (hypotension) occurs in one third of spinal anesthetics administered     to pregnant patients undergoing cesarean delivery. However, predicting which patients will     experience hypotension following spinal anesthesia has proven difficult. Pulse wave analysis     is a repeatable and reproducible method for investigation of cardiovascular function. A     device called a SphygmacorTM can be used to measure pulse. The pulse measurement is called     the Augmentation Index (AIx). AIx has been useful in detecting risks associated with blood     pressure changes after complex surgery in patients with heart and blood vessel disease. In     this study the investigators wish to see if it is possible to predict if a subject will     experience hypotension based on her AIx measurement preoperatively.   "
231525|NCT00884039|"     This study will investigate the use of anecortave acetate injection to reduce intraocular     pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated     pressure control problems. Alternative methods of IOP control have been shown to entail     serious risks. For example, reduction of topical steroids increases the risk of graft     rejection, and use of glaucoma medications or glaucoma surgery increases the risk of graft     failure. This study is designed to have sufficient power to detect whether a single injection     can induce a clinically significant IOP reduction.   "
231526|NCT00884052|"     The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of     Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.   "
231527|NCT00884065|"     While Diacutaneous fibrolysis (DF) has achieved promising results empirically, its     effectiveness has not been tested in clinical trials. The investigators hypothesized that the     use of DF in patients suffering from painful shoulder would increase the active mobility and     reduce the pain during movement. To test the hypothesis a double blind (patient and     investigator) randomized clinical trial was carried out in two public Primary Health Care     Centres. Fifty patients were randomly allocated to two groups: the intervention group, who     received a real DF session, and the control group, who received a placebo DF session.   "
231528|NCT00884078|"     Aim of the study is to adapt and develop a culturally appropriate psychological intervention     and to pilot test it's feasibility, and acceptability for the adult South Asian females     presenting to general hospital emergency department following self-harm. Primary hypothesis     for the study is to determine whether a brief psychological intervention compared with     treatment as usual for self-harm results in decreased hopelessness and suicidal ideation.     Further to this to collect necessary information on recruitment, the assessment instruments,     effect size, the optimal delivery and acceptability of the intervention in preparation for a     definitive RCT using repetition of self harm and cost effectiveness as the primary outcome     measures.   "
231529|NCT00884091|"     The purpose of the study is to standardize a meal test to facilitate future studies of the     postprandial glucagons-like peptide 1 (GLP-1) response in Chinese subjects. Eighteen healthy     Chinese subjects, aged between 20-65 years old, without history of diabetes, will be     recruited for the study. Each subject will receive two mixed meal tests for postprandial     GLP-1 excursion at random order: 60 % carbohydrate (CHO)/20 % fat vs. 50 % CHO/30 % fat. The     postprandial glucose, insulin, glucagon and other related hormones responses will also be     measured. Through the study, we hope to build up a platform for the study of the postprandial     GLP-1 response and insulin secretion.   "
231530|NCT00884104|"     The purpose of this study is to evaluate the rate of add-on solifenacin treatment and its     persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4     weeks.   "
231531|NCT00884117|"     This study will assist in the early detection of influenza resistant to antivirals and will     monitor the clinical outcome of adults and children infected with influenza according to     subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a     rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants     will be clinically managed according to local guidelines and the decision to treat/not treat     will be at the discretion of the Investigator.   "
231547|NCT00884338|"     The trial will evaluate the effects of an exercise program on the physical and cognitive     performance of patients with hematological neoplastic diseases after high dose chemotherapy     with stem cell support.   "
231532|NCT00884130|"     Hypothesis: The total costs of laparoscopic colorectal surgery are less than those of open     surgery.      Secondary hypothesis: Patients quality of life is higher following laparoscopic surgery, as     compared to open colorectal surgery.      Research objectives:        1. To estimate the cost implications and clinical benefits of incorporating laparoscopic          colorectal surgery into routine clinical practice.        2. To examine whether the increased operative costs of laparoscopic surgery are compensated          for by a faster recovery, shorter duration of hospital stay, and a reduction in late          complications, as compared to open surgery.        3. To investigate whether there are differences in quality of life following laparoscopic          colorectal surgery as compared to open surgery.      Lay summary:      Patients needing an operation for a bowel problem have traditionally had an open operation     with an incision on the abdomen, and this is the type of operation that is currently     performed in the majority of cases in the United Kingdom today (over 90%). Laparoscopic (or     keyhole) surgery has been introduced into bowel surgery, but is currently not widely     performed. This is because thus far there have been no clear-cut benefits demonstrated with     this technique and the perceived costs are higher than an open operation. The investigators     aim to evaluate both of these issues.   "
231533|NCT00884143|"     There are different types of hormonal therapy medicines for the treatment of     hormone-receptor-positive breast cancer. The purpose of this study is to determine the     evolution of two types of hormonal treatment (the drug called tamoxifen and a group of     medicines called aromatase inhibitors) during two time periods of 12 months each, in years     2006 and 2008, in the northeast Italian regions. The study will include post-menopausal women     who have initiated hormonal therapy medicines in 2006. The study will also verify the rate of     implementation of the updated national and international recommendations for the use of     adjuvant hormonal therapy in the hormone-receptor-positive breast cancer.   "
231534|NCT00884169|"     This study is to investigate the efficacy and safety of M518101 in male and female plaque     psoriasis patients with refractory plaques.   "
233635|NCT00905515|"     This study is designed to optimize calcineurin immunosuppressive regimens and evaluate     immunological and non-immunological markers that may explain mechanistic differences in these     agents and their effects.   "
231538|NCT00884221|"     The main purpose of this clinical research trial was to compare the ongoing pregnancy rate     between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant     follicle-stimulating hormone (FSH)), in cycles where a gonadotrophin-releasing hormone (GnRH)     antagonist was used for prevention of premature luteinizing hormone (LH) surge and where a     single embryo was transferred at the blastocyst stage.   "
231539|NCT00884234|"     The purpose of this study is to determine the safety and efficacy of 2 sequential doses of     RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.   "
231540|NCT00884247|"     The study aims to evaluate if a GERD treatment programme, in accordance with current regional     recommendations, in a company health care setting, has an impact on health related quality of     life (HRQoL), symptoms, and productivity in GERD patients.   "
231541|NCT00884260|"     The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG     (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for     use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be     performed.   "
231542|NCT00884273|"     This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the     current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6     mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix     (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in     prostate volume.      The hypothesis was that degarelix could decrease prostate size at least as effectively as the     combination of a GnRH agonist with an anti-androgen for flare protection.   "
231543|NCT00884286|"     This is a multicenter study to assess the anti-tumour activity,to investigate the safety     profile and to obtain additional pharmacokinetic information for Aplidin® given as 1-hour     weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.   "
231544|NCT00884299|"     Chronic obstructive pulmonary disease (COPD) is characterized by increased oxidative stress     which aggravates airway and systemic inflammation. Previous studies suggested that dietary     factors such as ample consumption of antioxidants might have beneficial effects in lung     function in COPD patients.      The investigators' primary aim is therefore to investigate prospectively whether a     nutritional intervention consisted of diet rich in antioxidants such as fresh fruits and     vegetables, would significantly affect lung function decline in COPD patients compared to a     free diet.      Methods: This is a 3-year prospective study, incorporating a run-in period of six months and     outpatient clinic visits, scheduled every 6 months. Consecutive sampling was used to recruit     120 patients with COPD. At baseline and at each visit all patients were evaluated for     respiratory symptoms, dietary habits, medication used and pulmonary function. Patients will     be randomized either to a diet based on increased consumption of foods containing     antioxidants (fresh fruits and vegetables), intervention group (IG) or, to a free diet,     control group (CG).      The investigators hypothesize that the results from the study will suggest that a diet rich     in antioxidants may be associated with improvement in lung function in COPD patients. In this     respect dietary interventions should be considered in the management of COPD.   "
231545|NCT00884312|"     This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and     efficacy of long-term or continuing carfilzomib therapy for subjects who previously completed     a primary carfilzomib treatment study. Only subjects who have adequately completed a prior     carfilzomib study will be eligible for the current study.   "
231548|NCT00884351|"     Background:        -  An absence seizure is a type of seizure that usually begins in childhood and goes away          by early adulthood. Scientists do not yet know where absence seizures begin in the          brain. Some evidence suggests that these seizures begin in the thalamus, a structure          deep in the brain, but other studies suggest that they begin in the frontal cortex, at          the front part of the brain.        -  Magnetoencephalography is a type of brain scanning procedure that is useful in          determining information about what happens to the brain during epileptic seizures.          Understanding where absence seizures come from may help doctors find new treatments for          them.      Objectives:        -  To gain a better understanding of which parts of the brain are affected in absence          seizures.      Eligibility:        -  Patients 7 to 35 years of age who have been diagnosed with absence seizures.      Design:        -  Procedures are for research purposes only, not to diagnose or treat a particular medical          condition.        -  Two outpatient visits to the National Institutes of Health Clinical Center: evaluation          and scanning.        -  Researchers will evaluate potential participants with a medical history, physical          examination, and electroencephalography (EEG). These tests will be performed under          another protocol, 01-N-0139.        -  Patients will undergo magnetoencephalography (MEG) and magnetic resonance imaging (MRI)          of the brain. The study procedures will be performed one time; however, an MEG or MRI          scan may need to be repeated for technical reasons. Researchers will not do more than          two MEG or MRI scans.        -  The MEG will record very small magnetic field changes produced by the activity of the          brain. An EEG will be recorded at the same time as the MEG.        -  The MRI will use a magnetic field to take pictures of the inside of the brain.        -  The MEG will take 3 hours to complete (2 hours for preparation, 1 hour in the scanner).          The MRI will take approximately 1 hour.   "
231549|NCT00884364|"     The trial will evaluate the effects of aerobic exercise in patients undergoing chemotherapy     for the treatment of a hematological neoplastic disease.   "
231550|NCT00884377|"     This study serves to compare the effectiveness of treating cutaneous leishmaniasis with     either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM     device.   "
231551|NCT00884390|"     The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and     other Factor VIII products.   "
231552|NCT00884403|"     Several large trials report gestational dating by last menstrual period (LMP) overestimates     gestational age (GA) vs. ultrasound (US) by approximately one week. Previous studies examined     only term pregnancies. The investigators hypothesize an opposite tendency in women seeking     abortion. This is an observational study undertaken by chart review.   "
231553|NCT00884416|"     This is a phase I study to evaluate the safety and tolerability of Sorafenib in combination     with Temodar and radiation therapy in patients with newly diagnosed high grade glioma     (glioblastoma, gliosarcoma, anaplastic astrocytoma and anaplastic oligodendroglioma or     oligoastrocytoma). The mechanism of action of sorafenib, an oral multikinase inhibitor, makes     it an interesting drug to investigate in the treatment of patients with high grade glioma as     this agent has anti-angiogenic activity and inhibits other pathways such as Ras,     Platelet-derived growth factor (PDGF) and fms-like tyrosine kinase receptor-3 (Flt-3), which     are potential targets against gliomas.   "
231554|NCT00884429|"     The purpose of this study is to verify the effectiveness of chest physiotherapy (actual     versus conventional) on respiratory distress in infants with acute viral bronchiolitis.   "
231555|NCT00884442|"     The present study will be performed to investigate and to compare the in-vivo performance of     the two investigational products Gen-nifedipine extended release, (previously referred to as     Gen-Nifedipine XL (Genpharm ULC, Canada)) and Nifedipine(Bayer Healthcare AG manufactured as     Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) by comparing their pharmacokinetic     parameters after oral single dose administrations in the fasted and fed state.   "
231556|NCT00884455|"     This is a long-term follow-up banking protocol that collects medical information and tissue     (blood, liver and lung) samples for future research; use of data and samples for research     purposes is overseen by the Tissue Bank Advisory Committee; the purpose of the Bank is to     further research on alpha-1 antitrypsin deficiency.   "
231557|NCT00884468|"     This is an epidemiological non-interventional study assessing the prevalence of anxiety     and/or depression disorders in patients suffering from Psoriatic Arthritis (PsA) in Spain.   "
231558|NCT00884481|"     The primary objective of this trial is to observe the Multiple Sclerosis (MS) related fatigue     during treatment with Tysabri as measured by changes in the fatigue scale for motor and     cognitive functions (FMSC) over the course of 12 months. The secondary objectives are: To     investigate changes in fatigue, capacity for work, Health Related Quality of Life (HRQol),     sleepiness, cognitive impairment, physically activity induced exhaustion, speed of walking,     status of MS disease progression and amount of walking at different times points after     initiation of Tysabri treatment in participants diagnosed with Relapsing-Remitting Multiple     Sclerosis (RRMS). Changes in fatigue are measured at 3, 6 and 9 months, whereas changes in     capacity for work, HRQoL, sleepiness, cognitive impairment, physical activity induced     exhaustion, speed of walking, status of MS disease progression and amount of walking are     measured at 6 and 12 months. To investigate correlation between fatigue and cognitive     impairment, depression and physically activity induced exhaustion and status of MS disease     progression in participants at baseline, 6 and 12 month of treatment with Tysabri and to     document any changes in fatigue related medication.   "
231559|NCT00884494|"     Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines     immediately after weight loss surgery. Some studies suggest that ghrelin may worsen an     individual's ability to respond to insulin. The purpose of this study is to determine if the     decline in ghrelin levels after weight loss surgery contributes to the improvement of insulin     sensitivity.   "
231560|NCT00884507|"     This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo     added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a     screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534     1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated     time on study treatment is 6 months, and the target sample size is 100-500 individuals.   "
231594|NCT00884975|"     Chronic obstructive pulmonary disease (COPD) exacerbation is a major cause of physician     visits and hospital admissions associated with acute respiratory failure, causing increased     morbidity and premature mortality and thus it can significantly affect Health Related Quality     of Life (HRQoL).      Previous studies suggested that patients who have experienced frequent exacerbation present     worse HRQoL compared to patients with infrequent exacerbations. However, there are still     questions regarding the relationship between HRQoL and exacerbations.      In the present study the investigators will study a cohort of COPD patients over 6 years,     they will document exacerbations, they will assess lung emphysema by computed tomography of     the chest and they will evaluate health related quality of life in COPD patients.      The investigators hypothesize that the extend of emphysema in COPD patients is positively     correlated with worsen Health related quality of life (HRQoL).   "
231561|NCT00884520|"     Phase: Exploratory Study      Objectives: To collect drug bio-distribution data, begin collection of baseline and     tumor/background imaging data, acquire experience to improve study design and the conduct of     future studies      Design: Exploratory, open label, nonrandomized, multi-center study      Duration: Three visits - one screening, one imaging, and one follow-up visit at 24 hours     post-dose      Procedures: Informed consent, collection of demographic information and medical history,     physical examinations, vital signs, 12-lead ECGs, routine blood tests to assess major organ     functions, complete blood counts and clinical chemistries for safety, blood sample for CA-IX     assay, pre-dose and post-dose blood samples for metabolite analysis, dosing with     [F-18]VM4-037, PET imaging scan, dosimetry estimation (normals), urine collections (normals),     tumor immunohistochemistry with CA-IX biomarker, follow up to imaging to collect adverse     events      Subjects: Approximately sixteen (16) adult subjects including four (4) healthy volunteers and     twelve (12) cancer subjects who have confirmed or highly suspected diagnosis of head & neck,     lung, large solitary hepatic and renal cell cancer, as defined by protocol criteria   "
231562|NCT00884533|"     This study is a randomised double blind, parallel group, and will evaluate the effects of     repeat oral doses of RSG- XR for 21 days on the QTc interval compared to placebo in a     population of healthy adult males and females.   "
231563|NCT00884546|"     To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923     administered alone, in combination with lenalidomide plus dexamethasone, or in combination     with bortezomib in subjects with relapsed or refractory multiple myeloma.   "
231564|NCT00884559|"     Whether teaching leadership with a short debriefing has a positive influence on the     performance of cardiopulmonary resuscitation remains largely unknown. The investigators will     assess the sustained efficacy of a short leadership debriefing compared to a technical     debriefing in a high fidelity simulated cardiopulmonary resuscitation.   "
231565|NCT00884585|"     This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the     treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The     study consists of a double-masked phase, and open-labeled phase, and an open-labeled     maintenance phase. For the first 3 months of the study, patients will receive either masked     Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients     may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients     who are in remission, will be re-randomized to receive either open-labeled Cyclosporine     0.010% eye drops four times daily or twice daily.   "
232077|NCT00890097|"     The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic     Solution versus Vehicle administered as a topical ocular drop for the treatment for     geographic atrophy (GA) secondary to age-related macular degeneration (AMD).   "
231566|NCT00884598|"     RATIONALE: Cilengitide may stop the growth of brain metastases by blocking blood flow to the     tumor. Radiation therapy uses high energy X-rays to kill tumor cells. Giving cilengitide     together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of cilengitide when     given together with whole-brain radiation therapy in treating patients with brain metastases     from lung cancer.   "
231567|NCT00884611|"     This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being     conducted at Stanford University Medical Center and the University of Colorado Barbara Davis     Center. It is paid for by the Juvenile Diabetes Research Foundation.      The purpose of doing this research study is to understand the best way to stop an insulin     infusion pump from delivering insulin to prevent a subject from having hypoglycemia. The     investigators think that if they take into account how quickly your blood sugar (glucose) is     dropping we can stop your basal insulin from your pump for 2 hours and keep you from going     low. The investigators hope that what they learn from this study can be used to set up     communication between a continuous glucose monitor and an insulin pump. However, the     investigators do not currently know the best way to do this.   "
231568|NCT00884624|"     The purpose of this study is to evaluate the ability of the PillCam Colon Capsule 2 to detect     polyps and other pathologies in the colon.   "
231569|NCT00884637|"     The FORESEE HOME is used in the recent years to detect Age-related Macular Degeneration (AMD)     lesions. The device is capable of differentiation as to stages of AMD and early detection of     changes including choroidal neovascularization (CNV) The Foresee HOME demonstrates a high     level of sensitivity and specificity as to the different stages of AMD including newly     diagnosed or early detection of CNV.      The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between     the two methods will allow better understanding of both devices.      The FORESEE HOME can use as an assessment tool for the progression and success of the     treatment given to AMD lesions. Therefore, evaluation the size and the location of the     treated lesions may serve as an additional tool.   "
231570|NCT00884650|"     The purpose of this study is to determine which pain management strategy continuous analgesic     pump or orally-should be used in the management of children with cerebral palsy.   "
231571|NCT00884663|"     The main aim of the present study is to compare candesartan with propranolol for migraine     prophylaxis.   "
231572|NCT00884676|"     RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone when     given together with sunitinib malate in treating patients with progressive advanced solid     tumors.   "
231573|NCT00884689|"     The purpose of this study is to describe the use of rescue medication and quality of life in     adult asthmatic patients, either treated with SYMBICORT SMART® (regular dose according to     physician's prescription and the current summary of product characteristics - SPC) or treated     with a free combination of ICS plus LABA plus as needed SABA prescribed by the physician.   "
231606|NCT00878254|"     The investigator(s) hypothesize that Rituximab together with combination chemotherapy,     followed by Rituximab maintenance therapy, will provide better disease control with improved     response rates and overall survival in patients with previously untreated Mantle Cell     Lymphoma (MCL).   "
231607|NCT00878267|"     The goal of this research study is to collect information to plan how to design a computer     program for cancer patients receiving palliative care, their caregivers, and doctors and     nurses who work in palliative care. Researchers want to learn how to make this program     practical for use by future patients, caregivers, doctors, and nurses.   "
231574|NCT00884702|"     Background:        -  The brain needs sleep to function normally, but the purpose of sleep is not understood.          Brain activity decreases during sleep, so it may be that sleep is important to maintain,          repair, or reorganize brain cells. In animals, the formation of brain proteins increases          during sleep, and the same thing may happen in humans.        -  There is also evidence that learning and memory are helped by sleep, and that the          synthesis of proteins in the brain are involved.      Objectives:        -  To examine the formation of proteins in the brain while people are awake, deprived of          sleep, and during sleep.        -  To look at the formation of proteins in the brain while awake or asleep and following          learning a task.      Eligibility:        -  Healthy volunteers between 18 and 28 years of age.        -  Volunteers must not have psychiatric, neurologic, or sleep disorders or certain types of          vision problems, and must be able to undergo imaging studies.      Design:        -  Study Part I (protein formation in waking, sleep deprivation, and sleep):        -  Participants will wear an actigraph (a unit to record motor activity) for 2 weeks prior          to admission.        -  Participants will have physical and psychological examinations, along with a blood          sample.        -  After admission participants will have three positron emission tomography (PET) scans to          study protein formation and one magnetic resonance imaging (MRI) scan over the course of          two days.        -  Participants may be asked to stay awake for as long as 20 hours and will be monitored          throughout.        -  Participants will be able to sleep overnight after they complete the required scans and          monitoring, and will be discharged the following morning.        -  Study Part II (protein formation in waking and sleep combined with a learning task):        -  Participants will wear an actigraph (a unit to record motor activity) for 2 weeks prior          to admission.        -  Participants will have physical and psychological examinations, along with a blood          sample.        -  After admission participants may be asked to stay awake for as long as 20 hours and will          be monitored throughout.        -  The next morning, participants will be trained to perform a computerized visual          discrimination task, and will be tested 8 hours later (after sleep or after remaining          awake) on the visual discrimination task.        -  Some participants may have PET and MRI scans as part of the study.        -  Participants will be able to sleep overnight after they complete the required tests and          scans, and will be discharged the following morning.        -  Participants will receive financial compensation for their participation in these          studies.   "
231575|NCT00884715|"     Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment     of the symptoms of carcinoid syndrome.   "
231576|NCT00884728|"     The purpose of this study is to determine whether a coordinated regional approach to healthy     skin programs in six remote Aboriginal communities can demonstrate, not only a reduction in     the burden of scabies and streptococcal skin sores, but also broad health benefits, including     primary prevention of some chronic diseases that occur at particularly high rates in     Australian Aboriginal communities.      The primary objectives of the Program are:        -  Demonstrate a reduction in scabies and skin sores on a regional basis        -  Demonstrate the broader public health effects of Healthy Skin Programs, particularly          those relating to chronic diseases such as rheumatic fever and renal diseases        -  Build on the existing Indigenous capacity by assisting in the development of new          knowledge and skills to improve the health and well being of Indigenous communities        -  Establish the feasibility of incorporating Healthy Skin Programs into existing health          service delivery   "
231597|NCT00885014|"     The purpose of the study is to examine the effectiveness of telephone cognitive-behavioral     therapy for subthreshold depression and presenteeism in workplace, in comparison with     treatment-as-usual (TAU) (which is minimal contact through Employers Assistance Program     (EAP)).   "
231577|NCT00884741|"     This randomized phase III trial studies temozolomide (TMZ) and radiation therapy (RT) to     compare how well they work with or without bevacizumab in treating patients with newly     diagnosed glioblastoma or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy     x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may find tumor cells     and help kill them. It is not yet known whether temozolomide and radiation therapy are more     effective when given together with or without bevacizumab in treating glioblastoma or     gliosarcoma.   "
231578|NCT00884754|"     Patients presenting for elective surgery requiring tracheal intubation will be randomized to     one of two different endotracheal tube (ETT) stylets. The intubation will be done with a     GlideScope videolaryngoscope by a novice operator. The primary outcome is time to intubation.   "
231579|NCT00884767|"     RATIONALE: Studying samples of blood in the laboratory from patients receiving oxaliplatin     for cancer may help doctors learn more about changes that occur in DNA and identify     biomarkers related to neurotoxicity.      PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients     with colorectal cancer receiving oxaliplatin.   "
231580|NCT00884780|"     The purpose of this study is to test the accuracy of a computer-based program to self-report     the location and intensity of a child's pain in comparison to a traditional self-report paper     and pencil measure and physician physical exam. Using a computer to assess pediatric pain may     offer many advantages and improvements in how pediatric pain is diagnosed and treated.   "
231581|NCT00884793|"     The PLUS study is a pilot study to measure the effect of therapy intensification (with     raltegravir and optional second agent) on HIV levels in the gut and blood in patients on     antiretroviral therapy (ART) with viral load < 50 copies/mL (herein referred to as     suppressed). We hypothesize that there is ongoing replication in the gut despite     suppressive ART and that this replication can be inhibited by the addition of one or two new     antiretroviral drugs whose activity affects a distinct part of the viral life cycle. All     study participants will have upper and lower endoscopy at baseline (before intensification)     and after intensification. These endoscopies will be used to obtain gut tissue and single     cells (for CD4+ cells) .   "
231582|NCT00884806|"     The purpose of this study is to clinically evaluate solution-related corneal staining with an     investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel     contact lens wearers.   "
231583|NCT00884819|"     This is a prospective randomized, double-blind placebo-controlled trial of 6 months' duration     evaluating the effect of fenofibrate (200 mg/day) in females with polycystic ovary syndrome     and mild hypertriglyceridemia. The investigators primary objective will be to determine     whether fenofibrate will reduce hepatic adiposity as measured using MRI, and our secondary     outcomes will be to delineate the impact of fenofibrate on biochemical or clinical parameters     for insulin resistance, cardiovascular disease, and reproductive status.   "
231584|NCT00884832|"     Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic     are doing a research study to assess the effects of a medication, clonidine, on fecal     incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug     Administration (FDA) for treating high blood pressure, but not for treating incontinence and     rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence,     increase rectal capacity and reduce rectal sensation to a greater extent than placebo in     women.   "
231585|NCT00884845|"     Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of     PM02734 administered in combination with erlotinib to determine the safety and tolerability     and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the     combination of PM02734 and erlotinib, in patients with advanced malignant solid tumors.   "
231608|NCT00878280|"     Assess the association of copy number variation (CNV) and inflammatory cytokine with the risk     of dementia.   "
231609|NCT00878293|"     The purpose of this trial is to determine whether the new centrally active analgesic and MS     Continus® are effective in the treatment of painful diabetic polyneuropathy.   "
231586|NCT00884858|"     Suboptimal improvement in cluster of differentiation 4 (CD4) cell count is not uncommon in     HIV-1-infected patients with suppressed plasma HIV-Ribonucleic acid (RNA) levels, and a     decrease in CD4 cell count in patients with suppressed or low level viremia has been     observed.      Although the efficacy of current antiretroviral medications is well established, some     antiviral combinations are very effective in suppressing HIV-1 load whereas do not exert any     effect on immune reconstitution.      Both T-cell immune activation and fibrosis of peripheral lymphoid tissue could create an     environment in which CD4 T cell count decrease in the setting of low or suppressed plasma     viremia is likely to occur.      Another fascinating hypothesis, which has still to be elucidated, is that reconstitution of     the depleted CD4 pool is blocked by an excess of glycoprotein 120 (gp120) HIV-1 protein. This     extra-production could be counteracted by an inhibitor of the chemokine (C-C motif) receptor     5 (CCR5) co-receptor that represents one of the major docking tools of HIV-1.      With this in mind, the investigators would like to propose and design a pilot exploratory     clinical trial involving a population of HIV-1-infected patients that rapidly reached a     virologic suppression without a reconstitution of their immune system.   "
231587|NCT00884871|"     The specific aim of this study is to evaluate the effect of surgically-induced weight     reduction, as achieved by laparoscopic gastric banding or sleeve gastrectomy, on pelvic floor     disorders such as stress urinary incontinence, overactive bladder, anal incontinence, and     pelvic organ prolapse in severely, morbidly and super-obese women using a prospective,     observational study design.   "
231612|NCT00878332|"     The purpose of this study is to evaluate histologic bone remodeling after interpositional     bone graft (sandwich osteotomy technique) using xenograft to fill the gap of the bone after     moving and fixation it in the proper place.   "
231647|NCT00885638|"     The regulation by DPP-4 inhibition after ingested of different individual macronutrients is     not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose     or mixed meal on the concentrations of incretin hormones and insulin secretion with or     without concomitant administration of a DPP-4 inhibitor (sitagliptin).   "
231588|NCT00884884|"     The current study investigates the effects of two potential alcohol treatment medications on     drinking in a laboratory setting. Aripiprazole (APZ), effects dopamine and serotonin     receptors with fewer limiting side effects seen with other atypical antipsychotics.     Topiramate (TPMT), an antiepileptic, affects glutamate and GABA-A receptors and shows promise     in reducing heavy drinking. Few studies have used two medications with such a diverse     combination of actions to examine a potential synergistic effect on reducing alcohol     consumption.      The primary aims are to:        1. determine if APZ and TPMT are each more effective than placebo, and the combination of          APZ and TPMT is more effective than either drug alone or placebo, in reducing alcohol          use in non-treatment seeking alcohol dependent subjects in a laboratory based alcohol          self-administration experiment (ASAE)        2. examine a hypothesized dose-response for three doses of APZ (0, 7.5 mg/d and 15 mg/d)          along with three doses of TPMT (0, 100mg/d and 200mg/d)        3. examine the putative mechanisms of action of APZ, TPMT alone and together on craving,          subjective stimulation, candidate gene influences and other behavioral effects          associated with alcohol consumption        4. establish the safety of giving APZ and TPMT together. Non-treatment seeking, alcohol          dependent Participants (N=216) will be recruited from the community and randomly          assigned to one of the 9 cells. Subjects drinking and safety is monitored over a 5-week          titration to their target dose, leading to an in-laboratory alcohol self administration          session, during which clinical and behavioral effects are assessed during access to          alcohol. A 1 month follow-up assesses adverse events and drinking.   "
231589|NCT00884897|"     Objective: Social Cognition and Emotional Intelligence have been shown to be deficient in     patients with schizophrenia and these are not remediated by antipsychotic medications or     psychosocial interventions. Social cognition is associated with functional outcome, an     important step in striving for recovery in this population. The hormone and neurotransmitter,     oxytocin, which has been associated with social bonding and trust has been shown to improve     measures of some aspects of social cognition in humans. The study will assess the effect of     acute administration of intranasal oxytocin on measures of social cognition and functioning     as well as on emotional intelligence and symptoms.      Study population: The study population will include patients with a DSM-IV diagnosis of     schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6     weeks. We will enroll a total of 30 subjects (N=15 placebo and N=15 oxytocin groups).      Experimental design and methods: After a one week lead in phase, participants will undergo 3     weeks of oxytocin (20 IU BID) or placebo administration (double blind) in addition to their     existing medication regimen. Outcome measures will be administered during the lead in phase,     and at the end of the study drug administration phase (under the acute effect of OT). The     primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)     and the Maryland Assessment of Social Competence (MASC). Secondary measures include rating     from the domains of social cognition (emotion perception, attributional style, theory of mind     and social perception), symptom rating and measures of social anxiety and quality of life.     Side effects and symptoms will be measured weekly.   "
231590|NCT00884910|"     The purpose of this study was to investigate the long-term feasibility of the new Provox Vega     22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system     (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis.   "
231591|NCT00884936|"     This study is a blinded, prospective, single-center, clinical study conducted in Japanese     female subjects between the ages of 20-75 years. This design uses skin biopsy samples from     environmentally exposed areas and unexposed (control) areas within the same subjects to     assess the gene expression profile from three different age groups.   "
231592|NCT00884949|"     This multicenter, open-label study is designed to assess safety, dose-response using     pharmacokinetic (PK) and pharmacodynamic (PD) measures, and clinical efficacy of BMN 110 in     subjects between 5 and 18 years of age, diagnosed with Mucopolysaccharidosis IVA (MPS IVA).   "
231593|NCT00884962|"     This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients     will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group     will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments,     respectively. All patients will receive treatment in a single lung under conscious sedation     or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR     treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be     analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to     be retreated at additional sites so that their total dose received is consistent with the     effective dose. All study patients will receive standard medical therapy in addition to PLVR.   "
232125|NCT00890721|"     Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and     their pain and pain medicine use will be monitored.   "
231595|NCT00884988|"     Ankle fractures are invariably complicated by severe soft-tissue swelling which can     significantly prevent surgical repair (open reduction and internal fixation - ORIF) of the     fractured bone for up to two weeks. The delay in surgical treatment can increase the risk for     local skin and bone complications, as well as for deep venous thrombosis. Lymphomyosot® is a     non-prescription, homeopathic complex drug which has been used for more than 70 years     throughout Europe and the U.S., primarily for tissue edema and swelling.      This is a randomized, placebo-controlled, double blind pilot study evaluating the     effectiveness of homeopathic combination drug Lymphomyosot® compared to placebo treatment.     The study will take place at the Shaare Zedek Medical Center in Jerusalem, Israel. Adult     patients (age 18 years and older) admitted to the orthopedic department with acute ankle     fractures which require ORIF repair will be assessed for inclusion in this study.      The primary outcome measure to be evaluated is the fracture-ORIF waiting period. Other     measures to be evaluated are: peri-malleolar circumference; pain (as measured by NRS and     analgesic use); duration of hospital stay; and complications such as poor wound healing,     blisters, and the development of deep vein thrombosis.   "
231596|NCT00885001|"     The general purpose of this pilot study is to determine the effects of a novel exercise     intervention (short arc banding (SAB)) on the cross sectional area of lumbar multifidus well     as functional outcomes assessments in patients with chronic low back pain.   "
231598|NCT00885027|"     This is an exploratory study, to evaluate the improvement in terms of quality of life that     can be reached by a group of outpatients with BPH ( Benign Prostatic Hyperplasia ) and     nocturia when they are under treatment with Secotex Ocas.      This study will explore, the progress in terms of quality of life that can be reached by a     group of outpatients with BPH ( Benign Prostatic Hyperplasia) and nocturia treated with     Secotex OCAS®.      This is a not controlled study,  before and after type, which will consist of an     assessment, of the quality of life for outpatients with BPH symptoms including nocturia,     through the use of the Spanish version of the Nocturia Quality-of-life (NQoL) questionnaire,     at three different moments:        1. Before to start Secotex OCAS® treatment.        2. Thirty (30) days after first visit and starting Secotex OCAS® treatment        3. Ninethy (90) days after first visit and starting Secotex Ocas® treatment   "
231599|NCT00885040|"     Background:        -  Many people can learn to use feedback about brain activity to modify that activity, but          is it not known if people with Tourette syndrome can modify their brain activity.        -  Researchers have evidence that certain areas of the brain are involved in causing tics          in people with Tourette syndrome. If people with Tourette syndrome can use feedback          about brain activity to modify activity in those parts of the brain, they may be able to          modify their brain activity to help control the tics.      Objectives:        -  To determine if people with and without Tourette syndrome can learn to use thought to          control brain activity.        -  To test whether people who have Tourette syndrome can learn to control brain activities,          possibly helping to control tics.      Eligibility:        -  Healthy volunteers ages 18 and older who are right-handed and are willing to not consume          caffeine or alcohol for 24 hours before the study visit.        -  Patients with Tourette syndrome who have tics that can be observed and studied.        -  All participants must be able to undergo magnetic resonance imaging (MRI) scans.      Design:        -  Healthy volunteers (two visits to the NIH Clinical Center over a 2- to 4-week period;          visit may last up to 3 hours):        -  Screening visit, including physical examination and medical history, and a magnetic          resonance imaging (MRI) scan if the individual has not had one performed at the National          Institutes of Health in the past year.        -  Study visit: Functional MRI (fMRI) scan to allow researchers to see if volunteers can          learn to control their brain activity during a scan. Volunteers will be asked to          complete tasks as directed during the fMRI scan.        -  Patients with Tourette syndrome (three or four outpatient visits over a 4- to 6-week          period; each visit may last up to 4 hours):        -  Screening visit, including physical examination and medical history, and an MRI scan if          the individual has not had one performed at the National Institutes of Health in the          past year.        -  Evaluation visit to ask questions about Tourette symptoms and to have patients complete          questionnaires about their tics and their mental health.        -  Study visit: fMRI scan to allow researchers to see if patients can learn to control          their brain activity during a scan. Patients will be asked to complete tasks as directed          during the fMRI scan.        -  Final visit: Researchers will ask questions about tic symptoms, have patients complete          questionnaires, and perform a brief exam. Afterward, patients will have an fMRI scan          similar to the previous one.        -  All participants will be paid a small amount of money in compensation for their          participation in the study.   "
231600|NCT00885053|"     The aim of this study is to investigate the effects of acute and short-term intervention with     fish oil on inflammatory markers in overweight subjects.   "
231601|NCT00885066|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given     together with capecitabine and erlotinib in treating patients with advanced pancreatic     cancer.   "
231602|NCT00885079|"     The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective     compared with active control in dry eye patients.   "
231603|NCT00885092|"     The purpose of this study is to clinically evaluate an investigational multi-purpose     disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of     silicone hydrogel contact lenses.   "
231604|NCT00878228|"     The study is a randomized placebo controlled trial to determine whether repeated     postoperative prophylactic ondansetron (Zofran) administration will prevent postoperative     and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy.     Ondansetron will be administered in the intra- and post-operative period. These individuals     will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of     postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative     prophylactic administration of multiple doses of ondansetron (Zofran).   "
231605|NCT00878241|"     Purpose:      Evaluation of the CAR™ 27 for the creation of compression anastomoses.      Indication:      Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during     colonic or colorectal resection.      Study Design:      Prospective, open labeled study.      Patient Population:      Male or female subjects 18 years of age or older who are scheduled for non emergency     laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy     can be preformed up to the discretion of the surgeon.      No. of Subjects:      15 patients estimated up to three months to enroll.      Duration of Treatment:      During the operation - creation of the anastomosis.      Duration of Follow-up:      Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic     visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone     after 3 months.      Endpoints:      To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse     events related to the use of the CAR™ 27 device.   "
232126|NCT00890734|"     The purpose of the study is to test whether treatment with CYT003-QbG10 can improve asthma     symptoms in patients with allergic bronchial asthma. The active treatment will be compared     against placebo.   "
231610|NCT00878306|"     The purpose of this study is to determine whether disulfiram might be a safe and effective     treatment for cocaine and/or alcohol dependence in patients with HIV disease. This research     is designed to characterize the presence or absence of significant drug interactions between     disulfiram and HIV medications using standard clinical pharmacology techniques as well as     monitor any side effects that might occur when these medications are administered together.   "
231611|NCT00878319|"     The purpose of this research study is to compare two different ways of treating a broken arm     (fractured humerus) using either, the nonoperative approach or the operative, open reduction     and internal fixation (ORIF). The study will examine which treatment will overall give better     results in regards to shoulder and elbow function, residual pain and deformity.      Patients who agree to consent to participation in this study will be randomly selected to     receive one of the two treatment methods:        1. Nonoperative: This method requires the application of a plaster sugartong splint for 10          - 14 days followed by a transition to a functional (coaptation) brace to be worn for 4-6          weeks. Patients will be followed by physiotherapy from the baseline visit at 2 weeks.        2. Operative: This treatment option involves an operative procedure for fixation of the          broken bone with plates and screws (open reduction internal fixation - ORIF). With this          method of treatment, a splint or sling is worn for comfort postoperatively. The patient          will be followed by physiotherapy after the post-operative visit at 2 weeks.      Standard follow-up clinic visits at 2 weeks, 6 weeks, 4 months, 6 months and 12 months will     be arranged from the date of randomization. The patient will be asked to complete two     questionnaires, reporting the level of wellbeing and physical function. These questionnaires     will be given to the patient at the time of baseline visit at 2 weeks and again at 6 weeks, 4     months, 6 months and 12 months. They should take approximately 10 - 20 minutes to complete.     At each appointment, the patients will be x-rayed until healing has occurred, examined and     evaluated (Constant Shoulder Score) by the surgeon and followed by physiotherapy for gentle     range of motion (ROM) exercises progressing to strengthening and proprioception of the elbow     and shoulder.   "
231613|NCT00878345|"     The investigators believe dexmedetomidine will provide superior sedation with reduced side     effects and reduced time to discharge compared with pentobarbital. The investigators have     developed sedation protocols with pentobarbital and dexmedetomidine in our ambulatory     procedure center. These protocols are both routinely used for sedation in our unit. The     investigators propose to study these two protocols in children ages 6 months to 6 years     presenting to the ambulatory procedure center for non-painful procedural sedation. The     investigators will compare failure of sedation, side effect profile, recovery and discharge     times between the two pharmacologic protocols.   "
231614|NCT00878358|"     Primary objective:      To compare the effects of short term therapy post total knee replacement (TKR) between a     hydrotherapy treatment group and a physiotherapy treatment group.      Secondary objectives:      To compare the effects of short term therapy post total knee replacement (TKR) between a     hydrotherapy treatment group and a physiotherapy treatment group based on measurements of     timed up and go (TUG, as primary outcome), range of motion, pain and quality of life.   "
231615|NCT00878371|"     The purpose for this study is to determine if surgery (repair of descending thoracic     aneurysm) causes a temporary decrease in the Blood Brain Barrier's ability to remove drugs     from the brain back into the blood. The Blood Brain Barrier surrounds the brain and the     spinal cord. This Blood Brain Barrier acts as a filter and allows some things to cross into     the brain and allows other matter to be removed. Studies have shown the Blood Brain Barrier     is affected by inflammation.      Functions of the Blood Brain Barrier in animals have been studied. Human studies with     multiple causes of inflammation (e.g. Alzheimer's, Epilepsy, trauma and severe infections in     critically      Hypothesis: Surgically-induced inflammation will temporarily reduce blood-brain barrier drug     efflux transporter function in proportion to the degree of inflammation. The investigators     anticipate that inflammation-mediated reductions in drug transporter function will be     reflected by an increased cerebral spinal fluid (CSF) concentration of morphine (a PGP     substrate) and M3G and M6G (MRP1 substrates). The corresponding in vitro studies will allow     us to elucidate the mechanism(s) by which inflammation alters blood brain barrier efflux     transport of morphine, M3G and M6G.   "
231616|NCT00878384|"     It is still uncertain what the best treatment is for patients who have both atrial     fibrillation (AF) and heart failure. The aim of the study is to help identify the optimal     treatment for patients with these two significant medical conditions. This will be performed     by comparing two alternative strategies for AF management: catheter ablation (to restore     normal rhythm) and medical therapy (to control heart rate, but not aiming ro restore normal     rhythm). After random assignment, the effect of each strategy will be assessed by looking for     changes in exercise capacity, symptoms, heart pump function, and quality of life during 12     months of follow-up.   "
231617|NCT00885105|"     The study is to compare the 2 Groups with respect to antibody responses to inactivated     influenza vaccine.      Observational Objectives:        -  To describe the percentage of participants with protective Hemagglutinin (HAI) antibody          titers to each of the 3 vaccine antigens in both study groups following each          vaccination.        -  To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in          both study groups following each vaccination.        -  To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in          both study groups.   "
231618|NCT00885118|"     The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety,     and tolerability of once daily oral administration of BI 10773 administered for 28 days in     Japanese patients with T2DM.   "
231619|NCT00885131|"     Background:        -  Magnetic resonance imaging (MRI) uses a strong magnetic field and radio waves to take          pictures of the brain. Some MRI studies suggest that this technique reveals brain          differences in patients with a nervous system illness when compared to adults without a          nervous system illness.      Objectives:        -  To study functional changes in the brain that may be observed in people without any          nervous system illness.        -  To learn more about which areas of the brain are necessary to perform certain tasks,          especially learning simple motor sequences and processing rewards.      Eligibility:        -  Healthy volunteers between the ages of 18 and 50 who are right-handed and are native          English speakers, and who have no medical conditions that would prevent them from          undergoing magnetic imaging.        -  Volunteers must not have a history of neurological or psychiatric illnesses.        -  Female volunteers must not be pregnant.      Design:        -  Volunteers will be asked to undergo different types of magnetic imaging, including          functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS),          and/or transcranial magnetic stimulation (TMS), while participating in either a slot          machine simulation or a key sequence learning task.        -  Volunteers will participate in one of four possible experiments:        -  Experiment 1: MRS/TMS and slot machine (3 visits, 3.5 hours in total).        -  Experiment 2: MRS/TMS and key sequence (3 visits, 3.5 hours in total).        -  Experiment 3: fMRI and slot machine (2 visits, 3 hours in total).        -  Experiment 4: fMRI and key sequence (1 visit, 2 hours in total).        -  Experiment types:        -  Slot machine: A computer game like a slot machine, where the user presses a button to          start the game and watches as the three barrels of the machine spin into place.        -  Key sequence: Pressing a series of buttons in response to visual cues.        -  Volunteers will also be asked to give a small blood sample for genetic testing.        -  Volunteers will be paid a small amount of money (approximately $50 $80) during the          experiments in compensation for their participation in the study.   "
231620|NCT00885144|"     The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have     been associated with improved growth and development outcomes among infants in Ghana and     Malawi. The investigators' study group has developed modified versions of such supplements     that theoretically will supplement infants diets better and with lower cost. As a preparation     for larger efficacy trials, the investigators now aim to test the acceptability of these     supplements among Malawian infants and their guardians. The trial hypothesis is that the     infants will consume on average at least 50% of an offered dose that consists of LNS mixed     with maize porridge.   "
231621|NCT00885157|"     The purpose of this study is to investigate the use of a fourth fractional booster dose of     sanofi pasteur's IMOVAX Polio injected intradermally (using the Mantoux technique) as booster     dose between 15 to 18 months of age, in terms of immunogenicity and safety.      Objectives:        -  To describe in each group the immunogenicity of IMOVAX Polio administered intradermally          or intramuscularly, one month after the booster dose given at 15-18 months of age in          toddlers previously primed with three doses of IMOVAX Polio vaccine during the IPV25          study.        -  To describe in each group the safety of the booster dose of IMOVAX Polio vaccine          administered intradermally or intramuscularly.   "
231622|NCT00885170|"     The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and     the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with     alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once     weekly will increase bone mineral density at the femoral neck compared to placebo at the end     of 24 months.   "
231623|NCT00885183|"     Breast cancer patients report many symptoms while undergoing conventional care, including     nausea/vomiting, fatigue, pain, depression and anxiety. Existing interventions to address     these common side effects of treatment are limited. Patients diagnosed with cancer frequently     seek complementary medicine (CAM), and there is a need to investigate potential effects of     CAM therapies. This phased pilot and feasibility study has two aims:        1. Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast          cancer patients undergoing chemotherapy using structured interviews with established          acupuncture teams in Norway.        2. Implement the treatment protocol in a pilot study to evaluate outcome measures, effect          sizes and acceptability of acupuncture care delivered alongside conventional care.      Study results will support the design of future research; including a Phase III randomised     controlled trial.   "
231624|NCT00885196|"     This study is designed to provide efficacy and safety data of several doses of AEB071 so that     the optimal dose and treatment duration can be chosen for testing in later studies in     patients with plaque psoriasis (with a disease severity such that systemic treatment is     justified). The treatment free Follow-up Period is designed to provide additional safety data     and information on disease recurrence after the last dose of the study drug.   "
231625|NCT00885209|"     The purpose of this study is to evaluate the effect of a modified Prep and procedure on colon     cleansing level and capsule excretion rate.   "
231626|NCT00885222|"     The purpose of this study is:        1. To determine, in the context of a prospective clinical trial, whether stimulation          parameters in PD patients treated with DBS, are associated with antidepressant effects.        2. To determine whether these antidepressant effects are related to or independent of          changes in the motor features of PD.        3. To establish a computerized database that includes stimulation parameters and clinical          parameters in PD patients treated with DBS.        4. To develop a computer-assisted decision making protocol for programming of DBS          parameters in both depressed and non-depressed PD patients.   "
231627|NCT00885235|"     The purpose of this study is to evaluate the effect of the PCCE preparation and procedure on     colon cleansing level and excretion rate.   "
231628|NCT00885248|"     In suspecting pancreatic cancer, dynamic phase pancreatic CT is the most effective tool in     diagnosis and staging. In addition, magnetic resolution image, endoscopic ultrasonography,     endoscopic retrograde pancreatography, angiography can be performed.      After introduction of functional image, PET has been suggested in the role of diagnosis and     staging of pancreatic cancer. Furthermore, recently fused images of PET and CT were     available.      In this study, the researchers evaluate the role of integrated PET-CT in patients with     pancreatic cancer and analysis the cost-effectiveness of the integrated PET-CT.   "
231629|NCT00885261|"     Obesity is considered as the epidemic of the century. Central obesity is one of the metabolic     syndrome's features. It has been proven that obesity can cause back pain and headaches; thus,     there might be a link between chronic pain and the syndrome.      The objective of this study is to assess the prevalence of metabolic syndrome in patients     suffering from chronic pain.   "
231630|NCT00885274|"     Pico-Salax is an osmotic and stimulant bowel cleansing agent used prior to colonoscopy. It is     unknown whether splitting the doses (i.e. taking the second dose the morning of the     colonoscopy) results in a better bowel cleansing, as research with other agents suggests this     may be the case. This study aims to assess whether splitting the dose of Pico-Salax results     in a better bowel cleansing than traditional dosing.   "
231643|NCT00885586|"     Symptoms that herald herpes zoster include pruritus, dysesthesia and pain along the     distribution of the involved dermatome. The most distressing symptom is typically pain and     the most feared complication is postherpetic neuralgia (PHN), the persistence of pain long     after rash healing. PHN is defined as pain persisting more than 3 months after the rash has     healed. Both, the acute pain associated with herpes zoster and the chronic pain of PHN, have     multiple adverse effects on health-related quality of life.      The primary objective of the trial presented is to investigate whether a 4 week     semi-standardised acupuncture is non-inferior (first step) or superior (second step) to (a)     the anticonvulsive drug gabapentin and (b) sham laser acupuncture in the treatment of pain     associated with herpes zoster in addition to standardised analgesics. Secondary objectives     include an assessment of the change of sensoric function, of long-term effectiveness, the     occurrence of PHN and an evaluation of several pain specific questionnaires   "
231770|NCT00887250|"     After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms,     after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks.     This study evaluated if losartan is more effective than placebo in lowering sitting diastolic     blood pressure and is well tolerated in patients with mild to moderate hypertension.   "
231631|NCT00885287|"     As HIV/AIDS is spreading in malaria-endemic countries, many patients here will need     concomitant treatment for both infections. Effective combination treatments are available for     both malaria (artemisinin-based combination treatments, ACTs) and HIV/AIDS (antiretroviral     combination treatments, ARTs), and these treatments are presently recommended for concomitant     use by ministries of health in many endemic countries, including Tanzania. However,     theoretically some of these drugs may be involved in harmful interactions with each other, as     they share common cytochrome enzymes involved in their metabolism. Such interactions could     lead to less effective treatments and/or adverse effects, as a consequence of reduced or     increased drug levels, respectively. Only little clinical and pharmacological information is     however yet available to guide clinicians and policy-makers on this issue.      The main aim of the InterACT study in Tanzania is to conduct a series of detailed     observational studies of clinical and paraclinical safety, therapeutic efficacy and     pharmacokinetic interactions between the currently nationally recommended first-line     treatment for malaria, artemether-lumefantrine, and first-line antiretroviral treatments,     primarily nevirapine-based combinations, for HIV/AIDS. The studies will be conducted among     patients with uncomplicated malaria, who attend the HIV/AIDS Care and Treatment Clinic and     Muheza Designated District Hospital in Muheza, north-eastern Tanzania, which is an area     characterized by intense transmission of Plasmodium falciparum malaria and with a prevalence     of HIV around 8-10%. The study is expected to inform guidelines for the treatment of malaria     in patients with HIV/AIDS in Tanzania, and elsewhere.   "
231632|NCT00885300|"     The purpose of this study is to investigate whether cloxacillin lock is effective in     prevention of double lumen infection.   "
231634|NCT00885326|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Zoledronic acid may stop the growth of tumor     cells in bone. Giving bevacizumab together with cyclophosphamide and zoledronic acid may kill     more tumor cells.      PURPOSE: This phase I trial is studying the side effects of giving bevacizumab together with     cyclophosphamide and zoledronic acid in treating patients with recurrent or refractory     high-risk neuroblastoma.   "
231635|NCT00885339|"     The purpose of this study is to compare two preparation and procedure in order to develop the     most optimal capsule procedure in regards to colon cleansing level and capsule excretion     rate.   "
231636|NCT00885352|"     This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431)     compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic     control who are taking pioglitazone and metformin.   "
231637|NCT00885365|"     The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is     non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one     second (FEV1) percent of predicted normal, and to compare the safety in participants with     cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.   "
231638|NCT00885378|"     The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for     participants taking saxagliptin in combination with metformin immediate release (IR) versus     metformin IR alone.   "
231639|NCT00885391|"     The purpose of this study is to learn whether the chemicals in the blood and urine are     different when the heart is atrial fibrillation compared to normal sinus rhythm.   "
231640|NCT00885404|"     The purpose of this study is to determine whether intravenous fluid management using lower     chloride solutions (Hartmann's solutions and Plasmalyte®) will result in better outcome when     compared to management using high chloride solutions (0.9% saline and Gelofusine®).   "
231641|NCT00885417|"     Helicobacter pylori infection has been shown to be associated with the development of gastric     cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the     occurence or recurrence of these diseases. However, it was estimated that 15-20% of patients     would fail from first line standard eradication therapy and need second line rescue therapy.     About 15-30% of patient would fail from second line therapy and need to be rescued with third     line therapy. The commonly used salvage regimens include:        1. Bismuth based quadruple therapy (combined with ranitidine or proton-pump inhibitor (PPI)          plus two antibiotics)        2. Levofloxacin or moxifloxacin or rifabutin based triple therapy.      However, Bismuth is not available in many countries and the administration method is complex.     Its usage is limited by the high pill number and low compliance rate. In recent years, the     concept of sequential therapy has been advocated in the treatment of H. pylori infection. The     regimen includes a PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin     and metronidazole for another five days. The eradication rate in the first line treatment of     sequential therapy had been reported to be as high as 90%. More importantly, it has been     demonstrated that the eradication rate among patients with clarithromycin-resistant strains     could be as high as 89%.      Aims: Therefore, the investigators aim to assess the efficacy of levofloxacin-based     sequential therapy as second line therapy for those who fail from one standard eradication     therapy.   "
231642|NCT00885430|"     Twenty adult volunteers will be administered Pico-Salax in the usual fashion for colonoscopy     with intense monitoring of serum and urine chemistry and hemodynamics.   "
231656|NCT00885755|"     This single arm study will evaluate alterations in molecular marker expression in     HER2-positive targeted therapy, and will evaluate the effect of continued treatment with     Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy.     Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading     dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease     within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda     (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken     for biomarker and gene profiling evaluation. The anticipated time on study treatment is until     disease progression, intolerable side effects or patient choice, and the target sample size     is 100 individuals.   "
231644|NCT00885599|"     Gingivitis, defined as inflammation of the gingival tissues, has long been associated with     bacterial accumulation [plaque] on the tooth surface adjacent to the gingiva, causing an     inflammatory reaction. Experimental gingivitis in health adults can be induced by abstension     from brushing teeth for 9 to 21 days, and can test the effects of numerous chemotherapeutic     agents, rinses and toothpastes. Effective prevention of plaque accumulation can prevent     destructive forms of periodontal disease.      A recent link has been established between localized gingival inflammation and systemic     inflammation and a number of disease processes. Periodontal disease may lead to elevated     C-reactive protein [CRP], considered a potential risk factor for cardiovascular disease and     stroke. It has been shown that reducing gingival inflammation is accompanied with a     significant decrease in serum CRP levels.      Naturopathic remedies for treating oral disease have been well documented in the medical and     dental literature since early civilization, and have become more and more popular in recent     years. We propose to study one such remedy, PERIORINSE. This remedy consists of a number of     herbs, and has been shown to exhibit antibacterial and anti—inflammatory effects.     Specifically, it has been shown to block the proteolytic effects seen in gingival     inflammation . This study will evaluate the efficacy of this formulation, using currently     accepted clinical testing protocols.      A Random sample of 100 healthy volunteers who fulfill all inclusion criteria and no exclusion     criteria, will be included in the study. Patients will randomly selected to one of 4     treatment groups: PERIORINSE (n=25), CPC (Cepacol) mouthwash (25 patients), Listerine     mouthwash (n=25), and placebo (colored water) mouthrinse. Patients will be examined at     baseline, and Gingival Index taken for all teeth. A blood specimen will be taken to measure     CRP levels as well. Patients will be given a full dental prophylaxis which includes scaling     and tooth polishing, and given rinsing instructions and reminded to cease all other oral     hygiene methods including brushing, flossing, and rinsing with any other rinse for a period     of 14 days. On day 14, patients will be re-examined and Gingival Index taken for all teeth.     Patients will be given a full dental prophylaxis which includes scaling and tooth polishing     and required to reinstitute their original oral hygiene regimen. CRP levels will be measured     again, as well.   "
231645|NCT00885612|"     10-year CHD risk evaluation and its treatment pattern analysis in postmenopausal early breast     cancer patients taking aromatase inhibitors.   "
231646|NCT00885625|"     Hypothesis: the efficacy of 2 doses 7-valent PCV is equivalent to 1 dose 7-valent PCV.   "
231672|NCT00885963|"     This is an open label, single arm, phase II study to evaluate the safety and efficacy of oral     sapacitabine administered twice daily for 5 consecutive days every week for 2 weeks followed     by 7-day rest in patients who have had one prior chemotherapy regimen for advanced Non-Small     Cell Lung Cancer (NSCLC).   "
231648|NCT00885651|"     Heart failure is a frequent disease in Denmark, and it is associated with very high     mortality. Around 60,000 people in Denmark have heart failure, and there is about 11,000     hospitalizations every year due to this disease. From the time of diagnosis, patients survive     an average of 4-5 years.      A critical illness mechanism in heart failure is that these patients have high blood levels     of catecholamines; epinephrine and norepinephrine, which is stress hormones from the     sympathetic nervous system. Standard treatment of heart failure is with the two medical     preparations betablockers and ACE-inhibitors.      It is not known what effect betablocker-treatment have on blood concentration of epinephrine     and norepinephrine.      It is the purpose of this study, to investigate the effect of Selo-Zok ® (metoprolol) on the     blood concentration of epinephrine and norepinephrine. This is done by creating a stress     condition for the body, in this case with the bicycle test, while doing blood samples to     determine the concentration of catecholamines. This will be done by 1-week treatment of     tablet Selo-Zok ® followed by 1-week treatment of placebo (a substance with no medical     effect). Blood samples will be taken to determine small changes in inheritance material (DNA)     in the form of point mutations also called single nucleotide polymorphisms, since these     changes can affect how we respond to metoprolol treatment.   "
231649|NCT00885664|"     The purposes of this study are:        1. To understand whether the use of HIV therapy in persons with more advanced HIV disease          results in greater side effects.        2. To determine whether these side effects can be related to greater activation of the          immune system.   "
231650|NCT00885677|"     The objective of this study is to compare two different strategies of disease management in     heart failure patients treated with cardiac resynchronization therapy devices        1. Remote monitoring with CareLink Network System        2. Standard management of the disease by means of scheduled routine in-patient follow-ups;      and to demonstrate that the remote monitoring strategy is superior to the standard strategy,     both in terms of clinical effectiveness and total healthcare system utilization.   "
231651|NCT00885690|"     Cognition is one of the core symptoms of schizophrenia. This study is a head-to-head trial     between olanzapine and sertindole with cognition as primary outcome. The design is a 12-week     double-blinded randomized controlled flexible dose study.   "
231652|NCT00885703|"     Cryptococcal meningitis (CM) is an infection of the membranes covering the brain and spinal     cord, caused by the fungus Cryptococcus neoformans. CM most often affects people with     compromised immune systems, like those with advanced HIV infection. This study will explore     the safety, tolerability, and therapeutic effect of a new treatment regimen with high-dose     fluconazole for management of CM in HIV-infected patients.   "
231653|NCT00885716|"     Patients suffering from schizophrenia who attend the communication skills program engage more     deeply in therapeutic reasoning and treatment decisions. This results in stronger preferences     to participate, greater perceived involvement and better long term adherence compared to     patients who do not attend the training.   "
231654|NCT00885729|"     The purpose of this study is to:        -  Compare the treatment efficacy of autologous mesenchymal stem cells (Mesenchymal Stem          Cells) versus chondrocytes implanted in a commercial available scaffold in a human          clinical trial.        -  Determine the effects of specific three months strength training program preoperatively          to improve knee function and possible postpone the need of cartilage repair surgery.        -  Determine if degenerative changes occur in the knee joints following cartilage repair.          This question will be investigated in the proposed clinical trial.        -  Determine the characteristics of patients treated either by surgery or by rehabilitation          in a long-term follow-up (1, 5 years).   "
231655|NCT00885742|"     Congenital deficiency of factor XIII (FXIII) is an extremely rare inherited disorder     associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to     patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood     in the usual clotting process, thereby preventing bleeding.      In this study, patients will be treated with FXIII Concentrate (Human) and followed closely     to determine that they receive the dose that will best minimize the chance of bruising and     bleeding.   "
231657|NCT00885768|"     All patients referred for coronary angiography will simultaneously be evaluated for renal     artery stenosis and then stenosis more than 50% will be analyzed according to clinical     conditions, risk factors and lab data.   "
231659|NCT00885794|"     Diabetic maculopathy is the leading cause of visual impairment in the working-age population     in developed countries. Diabetic macular edema can cause impaired visual acuity and so far is     treated by laser, vitreous surgery, and intravitreal cortisone application. Still 50% of the     cases do not respond to the treatment.      Recently intraocular anti-VEGF-treatment with ranibizumab (Lucentis®, Novartis) in diabetic     macular edema has proven efficacy to last over a period of 3 to 6 months. Still, the optimal     dosage for those intravitreal injections still has to be found, because frequent injections     are necessary.      The measurement of visual acuity is inadequate to quantify in detail the visual impairment.     Using the newest technology of a high-definition optical coherence tomography (Cirrus-OCT,     Carl Zeiss Meditec Inc.) to determine the retinal thickness, and a miroperimetry (MP-1, Nidek     Technologies) to determine retinal sensitivity, we hope to find the optimal dosage of     intravitreal anti-VEGF treatment in diabetic macular edema.      Study objective: To determine the dose response of 0.5mg and 1.0mg ranibizumab (Lucentis®,     Novartis Pharma) intravitreal injection in subjects with resistant diabetic macular edema and     evaluate safety and tolerability.   "
231660|NCT00885807|"     The purpose of the study is to evaluate the psychometric validation of the Weiss Functional     Impairment Rating Scale and the Weiss Symptom Record. It is hypothesized that the Weiss     Functional Impairment Rating Scale has strong psychometric properties and good convergent     validity with other measures of functioning and discriminant validity from symptoms and     quality of life.   "
231661|NCT00885820|"     This multicentre randomized, controlled trial (RCT) compared renal allograft histology and     function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol     biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.   "
231787|NCT00887471|"     The purpose of this study is to demonstrate similar improvements in sleep-disordered     breathing as determined by sleep study with microdebrider-assisted partial intracapsular     tonsillectomy and adenoidectomy versus total Bovie electrocautery tonsillectomy and     adenoidectomy.   "
231662|NCT00885833|"     Wiskott-Aldrich syndrome (WAS) is a rare X-linked congenital immune-deficiency syndrome and     hematopoietic stem cell transplantation (HSCT) has become a curative modality. But the     transplant with the conventional conditioning resulted in high incidence of treatment related     toxicities and non-myeloablative conditioning resulted in high incidence of engraftment     failure. Recently, fludarabine based reduced toxicity myeloablative conditioning regimen was     developed for adult myeloid malignancies with promising result of good engraftment and low     treatment related toxicities. To increase the engraftment potential without serious     complication, reduced toxicity myeloablative conditioning regimen composed of fludarabine,     busulfan, and thymoglobulin is designed for Wiskott-Aldrich syndrome.   "
231663|NCT00885846|"     Qigong therapy is a subtle energy-based methodology for preventing and healing diseases that     has been practiced with remarkable results in China for about five thousand years. Recently,     preliminary studies showed that Qigong exercises improve insulin resistance and glucose     metabolism in people with type 2 diabetes. These studies suggest that Qigong therapy might be     an effective and valuable complementary modality for treating type 2 diabetes. Type 2     diabetes is a chronic disease marked by abnormally high levels of sugar in the blood.     Diabetes is a serious disease, which, if not controlled, can be life threatening.      The purpose of this project is to conduct a randomized, controlled pilot clinical trial to     compare the effectiveness of Qigong therapy to mild exercise and conventional treatment in     type 2 diabetes and to identify biological and psychological characteristics associated with     subjects' responses to Qigong therapy.      Aim 1: To compare the effects on blood sugar and hemoglobin A1c (HbA1c) level between a     Qigong therapy group and non-treated control group as well as between Qigong group and a     progressive resistance training (PRT) group before, during and after and 12-week     intervention.      Hypothesis 1: Both Qigong therapy and PRT will help type 2 diabetic patients reduce blood     sugar levels to different degrees through improving insulin resistance. But the levels of     reduction of blood sugar will be greater by Qigong therapy than by PRT due to enhanced     insulin secretion.      Aim 2: To compare the effects on fasting C-peptide and insulin levels between a Qigong     therapy group, a PRT group and a non-treated control group before and after the intervention.      Hypothesis 2: Qigong therapy will increase the endogenous insulin and C-peptide levels by     restoring the functions of the pancreas, while PRT will not alter either insulin or C-peptide     levels.      Aim 3: To compare the effects of Qigong therapy and PRT on blood cortisol levels and     psychological stress levels before, during and after the intervention.      Hypothesis 3: Perceived stress and depression will be improved by Qigong therapy to a greater     extent than by PRT, and blood cortisol levels will be reduced to a greater extent with Qigong     therapy.   "
231664|NCT00885859|"     -  Transcutaneous electrical nerve stimulation (TENS) is a frequently applied therapy in          chronic pain. Although evidence regarding the effectiveness of TENS in chronic pain is          inconclusive many patients continue using TENS on long term in daily practice. An          important question is therefore why some patients respond well and others don't at all.          In chronic pain evidence for abnormal pain processing (sensitization) has been found in          several patients groups. The process of sensitization might influence effectiveness of          TENS as the theoretical working mechanism of TENS is based on the modulation of the          transmission of nociceptive impulses form peripheral receptors throughout spinal nerve          system into the brain. In this study we want to study the effect of TENS on pain          transmission, as measured by contact heat evoked potentials (CHEPS), between          'responders' and non-responders' after a two weeks TENS treatment. 'Responders' will be          defined as patients with a pain reduction of ≥ 30% on a VAS after a two week treatment          period with TENS. Non-responders are patients with a pain reduction < 15%.        -  Objective: a) Is pain reducing effect TENS in responders based on modulation of pain          transmission and perception, as measured by CHEPS? b) Is the ability of TENS to modulate          pain transmission and perception influenced by abnormal pain processing?        -  Prospective cohort study        -  Patients with chronic non specific pain (duration > 6 months), above 18 year, will be          included. Patients are referred from the Pain Clinic of the University Hospital          Maastricht (MUMC). Exclusion criteria are: a) pain due to cancer, b) the use of a          cardiac pacemaker, c) pregnancy, d) neurological sensory deficits, e) language and/or          cognitive inability to complete the health assessment questionnaires f) previous TENS          for pain relief.        -  Patients receive a two week treatment period with TENS-treatment, as regular, at home          after instruction. The frequency is set at 100 Hz and pulse duration at 250 μ sec.          Patients have to use the TENS daily (minimal 4 times a day for 30 minutes).      Main study parameters/endpoints are decrease in amplitude of CHEPS in responders versus     non-responders.   "
231665|NCT00885872|"     This study is to evaluate the effect of rosuvastatin 10-20 mg on carotid atherosclerosis     progression in Chinese patients by evaluating the change in the percentage of volume of lipid     rich necrotic core (LRNC) using high-resolution magnetic resonance imaging (MRI) after     24-months treatment.   "
231666|NCT00885885|"     The purpose of the study is to evaluate the efficacy and safety of the combination of     Panitumumab with FOLFOX 4 Chemotherapy or Panitumumab with FOLFIRI Chemotherapy in Subjects     with Wild- Type KRAS Colorectal Cancer and liver-only Metastases.   "
231667|NCT00885898|"     In the past, patients suffering from acute respiratory failure had to be treated with Oxygen     and specific medication, or - if this had not been sufficient - had to be anesthesized and     had to undergo endotracheal intubation for invasive ventilation. Nowadays, since emergency     ventilators are available that can be used for non-invasive ventilation, the purpose of this     study is to investigate if non-invasive ventilation is safe, feasible and effective for the     treatment of acute respiratory failure and if less patients will need to be intubated     out-of-hospital as well as in the further course.   "
231668|NCT00885911|"     The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically     engineered for use both as a stand-alone laryngeal mask airway (LMA) and as a rescue device     or Plan B device in the event of a difficult airway. As with some other types of LMA, it is     then possible to insert an endotracheal tube (ETT) through the Air-Q® ILA, either blindly or     mounted on a fibreoptic bronchoscope (FOB), to achieve endotracheal intubation. This will be     a prospective observational study of the Air-Q® ILA's performance.   "
231669|NCT00885924|"     Some patients undergoing cardiac surgery develop excessive postoperative bleeding.     Cardiopulmonary bypass causes platelet dysfunction. Several studies have documented the     ability of desmopressin to reduce hemorrhage in a variety of congenital and acquired platelet     disorders. In this study the investigators will investigate wether desmopressin reduces     postoperative microvascular bleeding. The investigators will investigate wether desmopressin     reduces platelet activation as measured by plasma concentration of neutrophil activating     peptid 2 and by flow cytometry. The primary endpoint of the study will, however, be total     postoperative bleeding and need for transfusions of blood components after surgery. The need     for transfusions will be registered during the whole hospital stay. Patient with excessive     postoperative bleeding (more than 250 ml for one hour, or more than 150ml for two hours     during the first four hours) will be randomized into two groups and given either desmopressin     or placebo (0,9% sodium chloride) as an intravenous infusion. Blood samples for plasma     concentration measurements will be drawn before infusion of desmopressin/placebo, immediately     after the infusion and 20 hours postoperatively. Postoperative bleeding will be registered     for 16 hours. The need for any transfusions of blood products will be registered for the     whole hospital stay.   "
231670|NCT00885937|"     The study is focused to prove a favorable safety profile of the new formulation.   "
231671|NCT00885950|"     The purpose of the study is to determine whether anticoagulant use (i.e. salicylates,     clopidogrel, low-molecular weight heparin, or coumarin derivates) is able to prevent the     development of the sinusoidal obstruction syndrome secondary to oxaliplatin-based neoadjuvant     chemotherapy in patients suffering from colorectal liver metastases.   "
231788|NCT00887484|"     The purpose of this study is to compare the tolerability of topical combination therapies in     the treatment of facial acne.   "
231673|NCT00885976|"     This study is intended to provide additional insight into the factors affecting     health-related quality of life with pediatric chronic pain as perceived by the patient versus     his or her parents.In doing so, additional insight into the subjective interpretation the     pediatric chronic pain experience will be gained. The four objectives of this study will be     (a) to examine further the relationship between patient self-reported health-related quality     of life and parent proxy-reported health-related quality; (b) to identify what biological,     psychological, and/or social factors are the strongest predictors of a pediatric chronic pain     patient's self-reported pain intensity and self-reported health-related quality of life, in a     diverse cohort of patients referred to and subsequently treated by an anesthesiology-based     yet interdisciplinary pediatric chronic pain medicine program; (c) to assess the effect of     patient-specific, pain-focused biopsychosocial treatment regimen on pain intensity and     health-related quality of life; and (d) to determine the effect of patient/parental     satisfaction with on-going health care on their compliance with and uptake of the pain     treatment regimen.   "
231674|NCT00885989|"     This study will investigate the safety and tolerability of the first IV dosing of SLV338 in     healthy volunteers.   "
231675|NCT00886002|"     The primary objective of this pilot trial is to identify pain model(s) which allow(s) to     compare and differentiate the analgesic effects between transdermal fentanyl 25Âµg/h,     transdermal fentanyl 12Âµg/h and placebo in a dose dependent way. The second objective is to     compare the effects of transdermal buprenorphine 35Âµg/h in these models with the effect of     the two transdermal fentanyl dosages. Therefore four different treatments are given; all     treatments will be by means of a patch that is attached to the back for 72 hours.   "
231676|NCT00886015|"     Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious     cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the     eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub     against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO)     has endorsed a multi-faceted strategy to combat trachoma which includes surgery to repair     lids distorted by trachoma (trichiasis) in imminent danger of vision loss. Current evidence     suggests that long-term success rates of trichiasis surgery are less than optimal due to     variation in surgical technique. Previous research by this study team has demonstrated that     shorter incisions have a higher rate of trichiasis recurrence. In addition, observations by     this team's oculoplastic surgeon have led to the hypothesis that granuloma formation and lid     contour abnormalities may result from current surgical practices. The objective of this study     is to compare outcomes of trichiasis surgeries performed with the newly developed     trachomatous trichiasis (TT) clamp versus surgeries following standard technique (bilamellar     tarsal rotation procedure or BLTR).   "
231677|NCT00886028|"     Liposomal doxorubicin consists on doxorubicin encapsulated in liposomes that are composed of     phosphatidylcholine and cholesterol. Liposomal doxorubicin can extravasate into tumors with     abnormal vascular endothelium but may not penetrate normal tissues lowering its toxicity and     increasing its efficiency. Combining Liposomal doxorubicin with cisplatin could be an     effective new chemotherapy treatment for malignant pleural mesothelioma .      Hypothesis:      Liposomal doxorubicin combined with cisplatin could increase response rates to chemotherapy,     progression free survival and overall survival in patients with malignant pleural     mesothelioma.   "
231678|NCT00886041|"     In this randomized controlled trial the investigators were looking for the best policy for     management of women with unexplained infertility after normal hysterosalpingogram (HSG). The     investigators test the hypothesis that postponing or even bypassing laparoscopy does not     affect the outcome of management of women with apparently unexplained infertility.   "
231679|NCT00886054|"     The purpose of this study is to use transcranial Doppler (TCD) to predict intracranial     pressure (ICP) and clinical outcome of neurocritical patients.   "
231680|NCT00886067|"     The primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's     (NNRs) and to determine the relation between plasma concentration of AZD1446 and the     occupancy at α4β2 NNRs.   "
231771|NCT00887263|"     The purpose of the study is to compare the efficacy and tolerability of budesonide 3 mg     effervescent tablet (9 mg/day) compared to placebo for the treatment of patients with     resistant oral cGvHD.   "
252912|NCT01166776|"     The purpose of this study is to isolate Umbilical cord Wharton's jelly matrix to be used as a     scaffold for tissue regenerative applications, including avascular necrosis.   "
231681|NCT00886080|"     Atrial fibrillation (AF) is connected with an increased morbidity and mortality. In addition,     quality of life is diminished due to palpitations, dyspnea, dizziness and syncope. AF is     frequently associated with valvular and coronary disease. In the AF patients undergoing     valvular or coronary surgery the arrhythmia almost always relapses. For symptom control     anti-arrhythmic drugs and cardioversion are used but breakthrough arrhythmias and side     effects of the drugs happen frequently. For more effective symptom control add-on     arrhythmia surgery is being advocated. However, at present the investigators do not know     whether add-on arrhythmia surgery indeed affects morbidity and quality of life.      The hypothesis being studied is that add-on arrhythmia surgery in patients with AF undergoing     valvular or coronary surgery improves quality of life, establishes chronic sinus rhythm and     reduces perioperative and long-term morbidity associated with AF.   "
231682|NCT00886093|"     The purpose of the study is to compare the plasma drug levels of PF-04447943 when taken as a     35 mg tablet after a high fat meal compared to when taken after fasting. Healthy adult     volunteers will receive a single dose of the drug once when fasted and again when fed. The     safety and tolerability of the drug will be monitored.   "
231709|NCT00886444|"     The aim of this study is to:        -  clarify whether macrophage imaging using ferucarbotran is able to delineate the region          of myocardial infarction as accurate as gadolinium-based necrosis/fibrosis imaging;        -  identify possible differences in infarct imaging using ferucarbotran for macrophage          imaging compared to necrosis/fibrosis imaging with gadolinium-based compounds; and        -  evaluate which MRI pulse-sequences maximise sensitivity for macrophage imaging with          ferucarbotran in the setting of acute myocardial infarction.   "
231997|NCT00889044|"     Since the absorption of clopidogrel through the gastrointestinal tract is limited, we want to     examine whether adding clopidogrel by chewing will overcome the limited gastrointestinal     absorption, and hence will improve the prevention of platelet aggregation.   "
231683|NCT00886106|"     Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and     leads to deterioration of quality of life. An injury or wound can lead to long term changes     in the nervous system that make the skin more sensitive at and near the injury; this is     termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the     synaptic interaction between neurons.      Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in     animal studies the investigators have discovered previously unrecognized effects of opioids.      Intradermal injection of capsaicin (injection of pepper extract into the skin) is an     established pain model in humans. The investigators want to test the influence of     remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal     capsaicin in human volunteers in a double blind cross-over prospective active placebo     controlled clinical trial.   "
231684|NCT00886119|"     The purpose of the trial is to compare the performance of two multifocal contact lens     systems/products in established presbyopic subjects.   "
231685|NCT00886132|"     This is a phase II study to evaluate the effectiveness of study drug sunitinib malate in     patients with recurrent and/or metastatic adenoid cystic carcinomas of the salivary gland.     There currently is not standard of care for this type of cancer and it has hoped that     sunitinib will have antitumor effects on patients with this type of cancer.   "
231686|NCT00886145|"     The purpose of this research study is to determine the effect of mechanical vibrations on     bones of persons with spinal cord injury.   "
231687|NCT00886158|"     Viral infections are an important complication of transplantation. Immunosuppressive therapy     interferes with T cell immunity resulting in a high incidence of viral infection. Newer     agents, such as mycophenolate mofetil (MMF) and sirolimus, have been associated with an     increased risk of herpes virus infection. The introduction of these more potent     immunosuppressive agents over the past decade correlates with an increase in the rate of     hospitalizations of transplant patients with infections. This prospective study will     determine the role of sub-clinical herpes virus infections in the development of     complications such as chronic allograft nephropathy (CAN) and Post Transplant     Lymphoproliferative Disease (PTLD). By focusing on treatable herpes virus infections, these     studies have the potential to identify therapeutic strategies that can be used to diminish     the burden of graft loss from CAN, significantly improving renal allograft survival and     quality of life in transplant patients. Future specific interventions to test the hypothesis     of a direct causal relationship between sub-clinical herpes virus infection and CAN may     include the use of anti-viral therapy in response to sub-clinical infection of the renal     allograft and/or peripheral blood.   "
231688|NCT00886171|"     The purpose of this study is to examine the effect of social skills training on adolescents     physical activity levels. For one week at the beginning and end of the study teens will wear     a BioTrainer to measure their activity levels and also wear a pager to communicate the types     of activities they are doing throughout the day. For 8 weeks participants will be randomized     into one of two groups, a social skills training group or a physical activity group.      The investigators predict that both groups will experience an increase in physical activity     and social involvement (decrease time spent alone).   "
231689|NCT00886184|"     The aim is to precise the place of therapeutic hypothermia induced before Return of     Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms     of biomarkers in inducing in early hypothermia compared to hypothermia induced only after     arrival at the hospital, there will be arguments to develop a higher scale study, allowing to     prove benefits in terms of survival and neurological status.   "
231690|NCT00886197|"     Gastroesophageal reflux disease (GERD) is a common disorder in Asia that includes erosive and     non-erosive counterparts. The evaluation of intra-esophageal damage is of paramount     importance because patients with erosive and those with non-erosive GERD have distinct     manifestations and prognoses. Although proton-pump inhibitor (PPI) is the treatment of choice     for erosive patients with excellent therapeutic response, the majority of reflux patients can     be classified with non-erosive reflux disease (NERD).Narrow-band imaging (NBI) is a novel,     noninvasive optical technique that adjusts reflected light to improve the contrast of     capillary patterns compared with conventional illumination. Based on the standard procedure     of sequential conventional white-light, NBI, and magnified NBI, the investigators have     validated the reliability of the diagnostic testing. The investigators will also enroll NERD     patients to test their therapeutic response to rabeprazole. The investigators can find out     the best strategy to identify the PPI responder.   "
231691|NCT00886210|"     Patients and methods: 100 patients were included in this study. They divided into two groups,     group (A) with drain and group (B) without drain. The investigators recorded the effect of     drainage on, postoperative pain (Po-P) using visual analogue scale VAS at 6, 24, 48 hours and     1 week postoperative nausea/vomiting at 6, 24, 48 hours postoperative, abdominal collection,     hospital stay, chest complication, and postoperative body temperature.   "
231692|NCT00886223|"     The aim of the study is to evaluate safety and outcome of robot-assisted laparoscopic     sacropexy regarding perioperative data, objective anatomical results and postoperative     quality of life.   "
231696|NCT00886275|"     In intensive care unit, patients suffered pain and anxiety from mechanical ventilation,     presence of endotracheal tube, central venous catheter, postoperative wound, and invasive     procedures. Adequate analgesia and sedation can reduce pain and anxiety. However, traditional     sedatives carry the risk of unstable hemodynamic status, respiratory depression, increased     mechanical ventilation time, incidence of delirium, and length of ICU stay. Dexmedetomidine     is a highly selec¬tive α2-adrenergic receptor agonist which causes sedative effects and     reduces opioid requirements in the perioperative period. Memis et al had found that     dexmedetomidine may prevent inflammatory effects in sepsis patients during sedation.     Oxidative stress status is related to the inflammatory response. Moreover, oxidative stress     may result in dysfunction of microcirculation. Dysfunction of microcirculation may cause     vasoconstriction or microthrombosis, and it will impair tissue perfusion and result in organ     dysfunction. The goal of this study is to compare the effects of dexmedetomidine and     midazolam on requirement of analgesics, weaning parameter, hemodynamic status, time of     extubation, incidence of delirium, and length of ICU stay, oxidative stress status, and     microcirculation.   "
231697|NCT00886288|"     This study was carried out in the context of daily medical practice to compare the     effectiveness of telmisartan in the treatment of hypertension complicated or not with the     presence of protein in the urine, which is called albuminuria. Hypertension is a chronic,     treatable but not curable disease and is defined as a combination of a systolic blood     pressure of 140 mmHg or more and a diastolic pressure of 90 mmHg or more. The kidneys are     often the first organs damaged by hypertension; renal damage could easily be diagnosed using     a urine dipstick and should be part of a routine examination in hypertensive patient. The aim     of the study is to see if the decrease of blood pressure (both systolic and diastolic) after     approximately 12 weeks of treatment with telmisartan in patients with albuminuria is the same     or different to that in patients without albuminuria. Every patient participating should have     two visits, approximately 12 weeks apart where his/her blood pressure was checked and a few     questions about is concomitant disease and drugs were asked.   "
231698|NCT00886301|"     The aim of the study is to find new clinico-biological and medical imaging parameters     associated with non alcoholic steatohepatitis in overweight and obese patients.   "
231699|NCT00886314|"     The purpose of the present investigation will be to determine whether a combination of clown     doctor and parental presence is more effective than a combination of sedative premedication     and parental presence for reducing anxiety in children and their parents and for improving     parental satisfaction.   "
231700|NCT00886327|"     Up to ¾ of patients who have been diagnosed with Crohn's disease (CD) will have to undergo     bowel resection during their lifetime despite modern medical therapies. Unfortunately,     disease recurrence is common and endoscopic detection of recurring inflammation precedes     clinical relapse. Endoscopic investigation is therefore recommended to manage these patients.      This multi center, prospective study compares the conventional endoscopic method,     ileo-colonoscopy to a new technique, i.e., colonic capsule endoscopy (CCE). CCE enables     investigation of the small bowel and the large intestines by using a double-sided video     camera with about 10 hours acquisition time.      This study aims to evaluate the performance of CCE to detect postoperative recurrence of CD     and detection rate of colonic and anastomotic recurrence is compared to ileo-colonoscopy.     Proximal (small bowel) lesions are additionally recorded and impact on clinical management of     the findings is accounted for. Moreover, safety aspects and influence of the findings on     progress of the disease are monitored. All consecutive patients who are operated for CD in     any of the participating study centers are eligible. Included are patients with segmental     small bowel, ileocecal or segmental colonic resection.      In some cases capsule retention has been reported at an average of 2-3% with CD patients at     elevated risk. Therefore, patency capsule is performed before application of the video CCE to     exclude bowel obstruction.      Sample size estimation results in n = 70, requiring each 140 capsule endoscopes and 140     patency capsules for performance of postoperative screening (ca 4-8 weeks postoperatively)     and detection of postoperative recurrence (ca 4-8 months postoperatively).   "
231701|NCT00886340|"     The purpose of this study was to evaluate the effect of a diabetes prevention program     provided by nurse practitioners in primary care to adults at risk for diabetes.   "
231702|NCT00886353|"     The purpose of this study is to define the dose for a Phase II study and to investigate     safety and tolerability of intravenous administration of recombinant soluble human     Angiotensin Converting Enzyme 2 in healthy volunteers.   "
231703|NCT00886366|"     The purpose of this study is to assess safety and tolerability of AZD6714 after single     ascending oral doses in healthy male subjects and type 2 diabetic patients.   "
231704|NCT00886379|"     This intervention study will address the impact of vitamin D fortified milk and vitamin D     supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone,     academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for     eczema) of Mongolian children.   "
231705|NCT00886392|"     The purpose of this study is to identify the severity level distribution at the moment of     diagnosis, in diabetic patients with macular edema from a Mexico City sample, and to identify     the rate with severe macular edema that needed immediate treatment.   "
231706|NCT00886405|"     Nitroglycerin will increase the effectiveness of treatment with induction chemotherapy and     concurrent chemo-radiotherapy by reducing chemo-radio resistance through an increased oxygen     pressure in tumoral tissue. The combination treatment of nitroglycerin and chemotherapy will     result in longer disease-free and over-all survival in patients with locally advanced NSCLC   "
231707|NCT00886418|"     Total intra-venous anesthesia can be provided using a closed-loop system guided by the     bispectral index. The purpose of this study is to determine if myorelaxation modifies its     functioning.   "
231772|NCT00887276|"     The purpose of this study is to prove the clinical and bacteriological non-inferiority of     ampicillin/amoxicillin versus moxifloxacin in hospitalized patients with non-severe     community-acquired pneumonia.   "
231865|NCT00881686|"     Adenosine has been proved to be an important mediator of myocardial protection induced by     ischemic preconditioning. The hypothesis of this study is that adenosine preconditioning can     provide additional myocardial protection in the setting of pediatric open heart surgery with     cardioplegia and cardiopulmonary bypass.   "
231708|NCT00886431|"     Human embryos can be preserved for later transfers by freezing. Traditionally the slow     cooling method has been used. About 70% of the embryos remain fully intact after thawing.     However, the remaining 30% of the embryos become (partially) damaged, and this freezing     damage reduces their chance to implant. Recently an ultra rapid freezing method, called     vitrification has been developed. During vitrification no damaging ice crystals are formed     and the embryo freezes in a glass like state.      It appears that the freezing damage is reduced when embryos are vitrified. Observational     studies in humans indicate that embryos are successfully preserved by vitrification, as     indicated by promising pregnancy rates following thawing. However, the effectiveness of     vitrification in relation to slow cooling with respect to pregnancy rates has so far not been     evaluated by a randomised, controlled trial. The aim of this study is to investigate whether     vitrification significantly improves embryo survival and ongoing pregnancy rates when     compared to embryos frozen by slow cooling.   "
231998|NCT00889057|"     Aim of this exploratory phase II study is to assess the clinical activity of sorafenib as     single agent, in terms of percentage of patients with high grade advanced osteosarcoma free     from progression following 4 months of therapy   "
231710|NCT00886457|"     The purpose of this study is to assess toxicities of a 1-hr infusion of     5-aza-2'-deoxycytidine (decitabine) x 10 days (M-F) plus escalating doses of weekly     subcutaneous PEG-interferon-α (PEG-Intron) in patients with metastatic cancer and to identify     the maximum tolerated dose of PEG-Intron in this combination. The pre- and post-treatment     samples will be evaluated to identify changes in molecular correlates.   "
231711|NCT00886470|"     The objective of this protocol is to perform a safety and dose-determination efficacy     clinical trial in patients having a degree of partial-thickness burn wounds. The trial will     be a prospectively randomized and double-blind trial of Amnion-derived Cellular Cytokine     Solution (ACCS) compared with standardized care using 0.9% NaCl (normal saline) solution in     the same three treatment regimens.   "
231712|NCT00886483|"     Neurofeedback is increasingly advocated for treatment of ADHD despite a thin evidence base.     The numerous open and partially controlled studies suffer serious design flaws. In     particular, there is no published double-blind randomized clinical trial (RCT), which would     control for experimenter and participant biases. The primary aim of this R34 pilot study is     to conduct a small-scale pilot with 39 8-12 year-olds with ADHD to prepare for such a larger     RCT.   "
231713|NCT00886496|"     RATIONALE: Recombinant human mannose-binding lectin (MBL) may be effective in preventing     infection in young patients with fever and neutropenia receiving chemotherapy for blood     disease or cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of recombinant human     mannose-binding lectin in treating young patients with MBL deficiency and fever and     neutropenia.   "
231714|NCT00886509|"     The purpose of this study in patients with stable coronary artery disease (CAD) treatable by     PCI (percutaneous coronary intervention) is to evaluate the long-term efficacy and safety of     subcutaneously applied, pegylated granulocyte colony stimulating factor (Pegfilgrastim,     PEG-G-CSF; Neulasta®, Amgen Switzerland) with regard to the promotion of collateral growth.   "
231715|NCT00886522|"     The purpose of this study is to evaluate the engraftment of donor hemopoiesis (proportion of     transplanted patients with successful engraftment at day +42) in adult patients affected by     high risk hematological malignancies after intrabone infusion of cord blood.   "
231716|NCT00886535|"     This study will be an open-label prospective observational trial designed to test     associations between polymorphisms of candidate genes and tamoxifen. Pre- and post-menopausal     women taking tamoxifen as standard therapy or chemopreventive therapy will be included in     this study.   "
231717|NCT00886548|"     The purpose of this study is:        -  To study the clinical usefulness of nurse-performed ultrasound and echocardiographic          examinations in a cardiac intensive care unit.        -  To study reproducibility of nurse-performed ultrasound and echocardiographic          examinations in a cardiac intensive care unit.        -  To study which ultrasound measure that best correlate with the amount of pleural          effusion.   "
231718|NCT00886561|"     This pilot study will test the efficacy of a behavioral intervention in reducing HIV related     risk behaviors among sex workers in Yerevan, Armenia.   "
231719|NCT00886574|"     This multi-center, randomized controlled study aims to evaluate the efficacy of Cilostazol     versus Aspirin for primary prevention of atherosclerotic events with Korean type 2 Diabetes     Mellitus (DM) patients.   "
231720|NCT00886587|"     The purpose of this study was to evaluate the safety of the investigational study product and     see how well it works to relieve signs and symptoms of children with mild to moderate Atopic     Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product.     This study was conducted to assess the safety of the investigational new study product and     how well it works to treat AD in children, by making AD visually better, and reducing the     amount of itch.   "
231721|NCT00886600|"     The purpose of this study was to evaluate the magnitude and durations of the antihypertensive     effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the     safety of losartan 50 and 100 mg doses compared to placebo.   "
231784|NCT00887432|"     This randomized clinical trial studies how well cholecalciferol supplement works in treating     patients with localized prostate cancer undergoing observation. Cholecalciferol may help     prostate cancer cells become more like normal cells, and to grow and spread more slowly.   "
231785|NCT00887445|"     First in man study with single and multiple rising doses with SLV341   "
231848|NCT00881465|"     Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric     obsessive-compulsive disorder (OCD), many people do receive CBT initially. Given this,     alternative ways of providing CBT need to be identified and tested. With this in mind, the     proposed study examines the efficacy of a videophone based cognitive-behavioral intervention     for youth with OCD. A total of 30 youth will be randomly assigned to either videophone     administered CBT or an abbreviated wait-list control arm. Comprehensive assessments will be     conducted by trained clinicians at relevant time-points to assess symptom severity and     impairment.   "
231731|NCT00886730|"     The purpose of this study is to develop and pilot test two interventions that lead to at     least 30% of individuals with depression presenting to primary care engaging with an     Internet-based depression support group. The investigators will identify primary care     patients with depression who state they have access to the Internet and are willing to     consider treatment for depression. In the primary care office they will be given one of three     interventions introducing them to the Internet depression support group site. The major     outcome will be accessing the depression Internet support group at least once in the     following four weeks.      The results of this study will provide important information on whether it is possible to     recruit a substantial proportion of primary care patients to engage in a potentially useful     and inexpensive addition to standard depression care. If this is not possible, the likelihood     of successfully completing a RCT of the effectiveness of depression Internet support groups     utilizing primary care patients would be low. Researchers trying to assess the effectiveness     of depression Internet support groups would have to go to alternative designs such as     recruiting patients with depression as they try to join the depression Internet support     groups and randomizing some to a delay in joining the group.   "
231940|NCT00888173|"     This phase II trial is studying how well brivanib alaninate works in treating patients with     endometrial cancer that has come back (recurred) or is persistent. Brivanib alaninate may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by     blocking blood flow to the tumor.   "
231722|NCT00886613|"     A study in two parts (Part A and Part B) to evaluate the responsiveness of various biomarkers     of immunity to Varicella-Zoster Virus (VZV) following repeated immunizations with heat     treated VZV vaccine V212 or with Zostavax™.      The enrollment of participants into this study was conducted in 2 parts, Part A and Part B.     The first 42 eligible participants were enrolled into Part A of the study. In Part A, the     reaction of the VZV skin test at baseline was evaluated at both 48 and 72 hours post     administration of the VZV skin test reagent and saline (in opposite arms), with 2 examiners     performing the reading at each timepoint; all subsequent skin test readings in Part A were     performed at 48 hours post administration. After all skin test reactions were obtained at     baseline for the 42 subjects in Part A, an interim analysis was performed (1) to assess the     frequency of baseline negative skin tests in order to confirm that the planned sample size     (N=120) was adequate for an evaluation of the effect of vaccination on the VZV Skin Test, and     (2) to assess the frequency of baseline positive skin tests at 72 hours relative to 48 hours     (post administration) in order to determine the preferred time for evaluation of the skin     test reaction.      The interim analysis from Part A confirmed the study sample size, an additional 78 subjects     were enrolled into Part B to achieve the planned sample size (N=120). The study procedures     for Part B of the study were identical to those in Part A with the following exceptions: (1)     baseline skin test readings were performed only once, at either 48 or 72 hours (post     administration) to accommodate the scheduling of clinic visits, and (2) only one examiner was     needed for the skin test reading at baseline.   "
231723|NCT00886626|"     The prevalence of severely obese children is on the rise. Behavioral therapies for weight     loss are successful in some, but others need more aggressive approaches such as drug therapy.     In addition, up to 25% of severely obese children have impaired glucose tolerance (IGT),     which places them at significantly elevated risk of developing type 2 diabetes mellitus and     cardiovascular disease. Although various drug therapies for weight loss and IGT have been     explored in adults, few have been evaluated in children.      Recently, a new drug class has emerged that targets deficiencies of GLP-1. One of the main     glycemic mechanisms of action of the GLP-1 agonists such as exenatide is to enhance glucose     disposal in the postprandial setting and improve glucose tolerance. In addition, exenatide     can induce weight loss by decreasing appetite and slowing gastric motility.   "
231724|NCT00886639|"     The aim of this study is to investigate the six-minute-walking-distance of COPD-patients with     breathing oxygen in comparison to breathing normal air. Patients, who increase their     walking-distance about more than 15% or 35m only because of breathing oxygen, are so-called     Oxygen Responders. The study is aimed to find attributes of Oxygen Responder and to     investigate, if a patient can change the respond with higher performance and endurance.   "
231725|NCT00886652|"     Adolescent Idiopathic Scoliosis (AIS) can change the respiratory dynamics and performance of     the inspiratory and expiratory muscles, affecting ventilatory capacity. This was a     randomized, controlled, open study to test the impact of a physiotherapeutic program of     aerobic exercises on respiratory muscle strength, in patients with adolescent idiopathic     scoliosis. Patients with AIS were randomly assigned to the aerobic exercise-training program     group or the no treatment group. There was a significant increase in Pimax and Pemax in the     group which received physiotherapy.   "
231726|NCT00886665|"     In order to provide a alternative treatment for relieving the pain and numbness of Diabetes     Mellitus patients,Traditional Chinese Medicine powder was tested by subjective questionnaire     and objective nerve conduction velocity study. Liver and kidney functions were tested to     provided safety profiles.   "
231727|NCT00886678|"     Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy     66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500     mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).   "
231728|NCT00886691|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and     everolimus may also stop the growth of tumor cells by blocking blood flow to the tumor. It is     not yet known whether bevacizumab is more effective when given together with or without     everolimus in treating ovarian epithelial cancer, fallopian tube cancer, or primary     peritoneal cancer.      PURPOSE: This randomized phase II trial is studying bevacizumab to see how well it works when     given with or without everolimus in treating patients with recurrent or persistent ovarian     epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.   "
231729|NCT00886704|"     An increase in intake of omega-3 fatty acids should increase the Omega-3 Index. Current     evidence indicates that this may lead to a reduction in risk for sudden cardiac death and     atherosclerotic diseases like myocardial infarction. The aim of the study is to investigate,     how supplementing a convenience drink with omega-3 fatty acids influences the Omega-3 Index,     as compared to an unsupplemented matching convenience drink. Palatability and safety of the     drink are also to be assessed.   "
231730|NCT00886717|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of     paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as     first-line therapy in treating patients with advanced ovarian cancer.   "
231815|NCT00887848|"     The purpose of the study is to investigate the effectiveness of robotic-assisted locomotor     therapy on improvements of functional gait parameters in ambulatory children with cerebral     palsy.   "
231816|NCT00887861|"     This study will asses the safety and efficacy of BGG492 in reducing the seizure rate in     therapy-refractory partial seizures.   "
231817|NCT00887874|"     This study is conducted in Asia. The aim of this observational study is to evaluate the     current status of diabetes management, control, and complications in diabetic subjects in     Asia.   "
231866|NCT00881699|"     This study will test the effectiveness of a program aimed at reducing behaviors that increase     HIV risk among people with severe mental illnesses.   "
231732|NCT00886743|"     This is an open-label study in which oprelvekin will be administered for the prevention of     severe low blood platelet cell counts (cells in your blood that keep bleeding and clotting     stable) in adults with cancer who are taking chemotherapy (anti-cancer drug) that has a side     effect of blocking your bone marrow from making platelet cells. The purpose of this study is     to learn more about the effects of the recommended dose of oprelvekin on the heart's     electrical cycle.   "
231733|NCT00886756|"     This is a Phase I, double-blind, placebo-controlled, randomised within each dose group,     single ascending dose study, with the objective to assess the safety, tolerability and     pharmacokinetic profile of AZD8529 in healthy Japanese subjects.   "
231734|NCT00886769|"     This study assessed the initial efficacy and safety of canakinumab over a 4 week period in     patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to     treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30     criteria at Day 15.   "
231735|NCT00886782|"     The purpose of this study is to determine safety, tolerability and maximum tolerated dose of     BMS-863233 in subjects advanced and/or Metastatic solid tumors.   "
231736|NCT00886795|"     This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and     effective in treating people with chronic urticaria (persistent hives).   "
231737|NCT00886808|"     The goal of the study is to evaluate the safety and tolerability of 4 different doses of     iCo-007 Intravitreal Injection in patients with diffuse diabetic macular edema.   "
231738|NCT00886821|"     The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2     diabetic patients.   "
231739|NCT00886834|"     The purpose of this study is to see if inserting misoprostol in the vagina or between your     cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a     baby makes it easier and less painful.   "
231740|NCT00886847|"     Primary objective:        -  To estimate the degree of agreement in diagnosis of cytologic samples from mediastinal          lymph nodes obtained by Endobronchial Ultrasound (EBUS)-guided Fine Needle Capillary          Sampling (FNC) versus Fine Needle Aspiration (FNA).      Secondary objective:        -  To compare the quality of cytologic samples from mediastinal lymph nodes obtained by          EBUS-guided FNC versus FNA. The quality of the samples will be assessed initially by          MDACC on-site cytology technicians, and then corroborated by physicians in the          department of cytology. This assessment will be performed utilizing the Mair's score 3.          The score consists of a 0-10 scale: 1-2= poor; 3-6=good; 7-10=superior.   "
231741|NCT00886860|"     The purpose of this study is to compare the efficacy for cervical ripening in labor induction     between titrated and conventional oral misoprostol   "
231742|NCT00886873|"     The objectives of this study are to estimate the efficacy and safety of the daily     administration for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried     out to estimate how the effects of mifepristone are kept in time.      The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma     up to 50% in six months treatment.   "
231743|NCT00886886|"     MDMA releases dopamine, serotonin, and norepinephrine in the brain. Serotonin uptake     inhibitors have been shown to interact with 3,4-Methylenedioxymethamphetamine (MDMA) and to     decrease its psychoactive and cardiovascular stimulant effects. This finding indicates that     MDMA acts in part by releasing serotonin through the serotonin uptake site. However, in vitro     studies show that MDMA binds more potently to the norepinephrine uptake site that to the the     serotonin or dopamine uptake transporter. In addition, norepinephrine uptake site blockers     such antidepressant drugs attenuate some of the behavioral effects of MDMA in animals. These     preclinical data indicate that norepinephrine may also contribute to the response to MDMA in     humans. To test this hypothesis this study evaluates the interacting effects of the selective     norepinephrine transporter inhibitor reboxetine on the subjective and cardiovascular     stimulant effects of MDMA in healthy volunteers.   "
231744|NCT00886899|"     Prospective, non-randomized, multicenter study in subjects with coronary artery chronic total     occlusions (CTOs). Published results of safety and effectiveness of conventional techniques     will be used for comparison. Enrollment of up to 149 subjects with a CTO refractory to     currently marketed guidewire use and meeting all inclusion/exclusion criteria at up to 15 US     clinical sites. Hypothesis is that the BridgePoint Medical System is safe and effective in     treating coronary CTOs compared to CTO literature.   "
231745|NCT00886912|"     Some studies suggest that high-altitude related illnesses - like acute mountain sickness -     could be prevented by acclimatisation, reached at low altitude using training in simulated     altitude. The purpose of this study is to determine whether training in hypoxia is suitable     to prevent acute mountain sickness.   "
231746|NCT00886925|"     The purpose of this study is to determine whether the administration of albumin in addition     to the standard care is effective in the treatment of an episode of hepatic encephalopathy in     patients with cirrhosis.   "
231912|NCT00882297|"     There is actually two techniques of subclavian vein ultrasonography-guided venous     catheterization : the axial and longitudinal approach. Currently, nothing makes it possible     to privilege one technique compared to the other. This study aims to determine the best     ultrasonography-guided method.   "
231747|NCT00886938|"     The neurological basis of tinnitus is uncertain when there is no evidence of damage to the     peripheral auditory system. However, neuroimaging studies of tinnitus patients show     hyperactivity in several cortical regions, especially the auditory cortices and middle     temporal regions. A potentially promising treatment modality for tinnitus is repetitive     transcranial magnetic stimulation (rTMS). rTMS involves the application of frequent, repeated     magnetic stimuli to the skull to induce electrical activity in the underlying cortical areas     of the brain. When the magnetic device is placed on the skull, the resultant magnetic field     passes through the skull and induces a small secondary current in the cortex. It has been     hypothesized that the effect of the frequency used in rTMS differentially influences cortical     activity with low-frequency (1Hz) stimulation decreasing and high-frequency stimulation     (10-20 Hz) increasing cortical activity.      Currently, reports on treating tinnitus with rTMS have focused on low-frequency stimulation     of the left auditory cortex, an area that has been demonstrated to be hyperactive in     tinnitus. The benefits of low-frequency auditory cortex stimulation are time limited however.     Converging data implicate structures of the brain that are important for mood and attention     as playing a role in the maintenance of tinnitus; suggesting an alternative rTMS treatment     approach that targets these structures. A growing number of studies demonstrate involvement     of the prefrontal cortex in the generation and maintenance of tinnitus. rTMS stimulation in     the dorsolateral prefrontal cortex in association with stimulation in the temporoparietal     cortex has been shown to increase the durability of the TPC stimulation. The independent     effect of rTMS stimulation to the DLPFC is not known. Studies in depression suggest that     increasing the intensity and duration of stimulation has beneficial treatment effects.     However, the field is new and more work is needed to assess the effectiveness of this     treatment, predictors and correlates of response, and safety.      Herein, we propose an open-label pilot study investigating the effectiveness of rTMS     stimulation of the dorsolateral prefrontal cortex, an area known to be important for mood and     attention, in the treatment of tinnitus   "
231748|NCT00886951|"     The main objectives of this proposal are as follows:        -  To assess the dynamic uptake and washout of 123-I MNI-388 and MNI 390, a potential          imaging biomarker for β-amyloid burden in brain, using single photon emission computed          tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls        -  To perform blood metabolite characterization of 123-I MNI-388 and MNI-390 in healthy and          AD subjects to determine the metabolic fate and nature of metabolites in assessment of          123-I MNI-388 and MNI 390 as a single photon computed tomography (SPECT) brain imaging          agent   "
231749|NCT00886964|"     The purpose of this study is :        -  To evaluate prevalence of protective hepatitis B antibody comparing intradermal (ID) and          intramuscular (IM) route in antiHbsAb negative HIV infected children treated with highly          active antiretroviral therapy (HAART)        -  To revaccinate the HBV vaccine in the children who didn't have protective HBV Ab   "
231750|NCT00886977|"     The efficacy and safety are evaluated when YAM80 is administered orally to the patients of     Amyotrophic Lateral Sclerosis (ALS).   "
231751|NCT00886990|"     The virological efficacy will be no different in children treated with single versus double     boosted PI second line ART regimens.   "
231752|NCT00887003|"     The purpose of this study is to examine 4 different epidural dosing regimes of local     anaesthetic solution in a series of 3 epidural injections over a period of 12 months to     determine the optimum dose of anaesthetic solution for pain relief and to determine the     nature of any adverse events by measuring anxiety and depression, functionality and any side     effects of the medication.   "
231753|NCT00887029|"     Hypothesis:        -  H1: Efficacy of Duotrav will be superior to Xalacom at 24 hours post dosing when both          medications are given in the morning        -  H2: A significant proportion of patients will prefer dosing of once daily topical fixed          combination therapy in the morning compared to evening dosing   "
231754|NCT00887042|"     Cord blood transplantation (CBT) is an alternative option for patients with pediatric acute     leukemia that indicated stem cell transplantation. Although CBT is as affective as unrelated     bone marrow transplantation with lower graft versus host disease (GVHD) severity and     incidence, transplantation related mortality (TRM) has been major problems after     myeloablative conditioning. To reduce TRM, CBT with non-myeloablative conditionings have been     performed but not so satisfactory especially for engraftment rate. Recently reduced toxicity     myeloablative conditioning regimen was developed with promising result in adult bone marrow     or mobilized peripheral blood transplantation. To increase the engraftment potential with low     TRM rate, reduced toxicity myeloablative conditioning composed of fludarabine, intravenous     busulfan plus thymoglobulin is planned for pediatric patients with acute myeloid leukemia.   "
231755|NCT00887055|"     The purpose of this study is to characterize the morphology (shape) of the intracardiac     electrograms(EGM) from patients with a resynchronization therapy device.   "
231756|NCT00887068|"     The goal of this clinical research study is to learn if Vidaza (azacitidine) will help to     control the disease in patients with AML, CMML, or MDS after an allogeneic (donor) stem cell     transplant. The safety of this drug will also be studied.   "
231757|NCT00887081|"     Worldwide, several studies report that 4.4% to 85.4% of thalassemia patients were positive     for anti hepatitis C antibodies. Recently, three different studies reported the efficacy and     the safety of combination therapy with pegylated interferon and ribavirin in thalassemic     patients. This study is carried ahead to assess the impact of combination therapy with     pegylated-interferon and ribavirin in a large cohort of italian patients with beta     thalassemia major - transfused and not transfused, sickle cell disease and     sickle/beta-thalassemia.   "
231758|NCT00887094|"     Many studies were already performed showing beneficial cardiovascular and metabolic effects     of physical training for type 2 diabetic patients. However, glucose profile during and     immediately after a short period of aerobic and/or resistance training was not studied yet.     Continuous glucose monitoring system (CGMS) has now been added to the repertoire of     technological devices useful in the management of patients with diabetes. Such monitoring     enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable     with intermittent testing of blood glucose. The main aim of the present study is to     investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and     ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2     diabetic patients.   "
231759|NCT00887107|"     The purpose of this study is to assess whether therapy with Sorafenib reinduces radioiodine     uptake in thyroid carcinoma.   "
231760|NCT00887120|"     To study the pharmacokinetics of low-dose and standard dose, lopinavir/ritonavir in ARV PI     naive HIV-1 infected Thai children.      To study clinical and immunological efficacy after 48 weeks of lopinavir/ritonavir in PI     naïve HIV-1 infected Thai children   "
231818|NCT00887887|"     The purpose of the study is to test whether the presence of polymorphisms in genes encoding     substances of the innate immune response in patients undergoing partial hepatic resection     because of benign or malignant hepatobiliary disease is related to a higher incidence of     infectious complications, post-resectional liver failure or mortality.   "
231819|NCT00887900|"     The purpose of this study is to report outcomes of deep anterior lamellar keratoplasty (DALK)     using the big-bubble technique.   "
231786|NCT00887458|"     This research is being done to test an investigational drug, called itraconazole, in the     treatment of prostate cancer. Itraconazole is approved by the Food and Drug Administration     (FDA) for the treatment of various fungal infections such as fingernail/toenail infections     and other more serious fungal infections. The word investigational means that itraconazole     is not approved for use in people with cancer. However, the FDA is allowing the use of     itraconazole in this research study. Itraconazole has been shown to have activity against     cancer (including prostate cancer) in the laboratory, but has not been tested against cancer     in humans.      The purpose of this study is to find out:        -  If itraconazole is safe when given at two different doses        -  How itraconazole affects prostate specific antigen (PSA): a blood test that measures          substances released by prostate cancer        -  Whether itraconazole can delay further prostate cancer growth and spread        -  How itraconazole affects other markers of prostate cancer   "
231999|NCT00889070|"     Assess the burden of disease associated with RSV infection with premature children in an     outpatient setting.   "
231761|NCT00887133|"     Background:      Primary care plays an important role in health care delivery, but there is little research on     its effectiveness. Western medicine is the most widely used and Traditional Chinese medicine     (TCM) is gaining popularity. The investigators recent study showed that TCM consultations at     the TWH were effective in improving the quality of life of patients in primary care. The aim     of the present study is to evaluate the effectiveness of Western Medicine (WM) in primary     care for comparison with the effectiveness of TCM consultations, so that policy makers and     the public can be better informed.      Objectives:      To evaluate whether WM consultation can significantly improve the quality of life of patients     in primary care and to find out whether there is any difference in the effectiveness of WM     and TCM, overall and for different health problems.      Design, Setting & Subjects:      A prospective study on 700 patients recruited from the TWH and the Ap Lei Chau primary care     outpatient clinics (OPC) in Hong Kong.      Methods:      All patients consulting for a new episode of illness at the study OPC will be recruited if     they meet the selection criteria and consent to participate. Each patient will be asked to     complete a structured questionnaire on socio-demography, morbidity and service utilization,     the Hong Kong version of the Chinese Quality of Life instrument (ChQOL-HK), the Chinese (Hong     Kong) SF-36 (SF-36-HK) and the PEI-2 before the consultation. Each subject will be followed     up two weeks later either at the clinic or by telephone to complete the ChQOL-HK and the     SF-36-HK again together with the Patient Enablement Instrument (PEI), the Global Rating Scale     (GRS) on change of the condition, and a questionnaire on service utilization      Outcome Measures and Data Analysis:      The primary outcome measures are the changes in ChQOL-HK and SF-36-HK scores after the     consultation. The GRS and PEI scores will be secondary outcomes. The ChQOL -HK and SF-36-HK     scores will be correlated with the the GRS and PEI. Multivariate regressions will be carried     out to identify factors that are associated with effectiveness. The outcomes will be compared     with those obtained from the previous study on the TCM primary care clinics.      Results:      This is the first study in Hong Kong to evaluate the effectiveness of WM in primary care with     a validated generic outcome measure, HRQOL. It will provide information on the benefit and     limitations of WM, and allow a direct comparison between WM and TCM.   "
231762|NCT00887146|"     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,     such as temozolomide, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. It is not yet known whether giving     radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is     more effective in treating anaplastic glioma or low grade glioma.   "
231763|NCT00887159|"     This randomized phase II trial studies cisplatin and etoposide to see how well they work when     given with or without Hedgehog inhibitor GDC-0449 (vismodegib) or IGF-1R MOAB IMC-A12     (cixutumumab) in treating patients with extensive-stage small cell lung cancer. Drugs used in     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Etoposide may slow the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Vismodegib may slow the growth of tumor cells. Monoclonal antibodies,     such as cixutumumab, may interfere with the ability of tumor cells to grow and spread. It is     not yet known whether giving cisplatin and etoposide are more effective when given together     with vismodegib or cixutumumab in treating small cell lung cancer.   "
231764|NCT00887172|"     Upper respiratory tract infections (URTIs) are the most common illnesses in primary medical     services but there is no established cure for these conditions in Western medicine. In Hong     Kong, many patients use Chinese herbal medicine (CHM) for the treatment of URTIs but there is     little research evidence on their effectiveness or side effects. The aim of this study is to     test whether two commonly used Chinese herbal medicine (CHM) formulae guided by Traditional     Chinese medicine (TCM) diagnosis will significantly increase recovery rate, and reduce the     duration and/or severity of symptoms, and improve the quality of life of patients with URTIs     in primary care.      If a patient consents to take part in the study and is found eligible, he/she will be invited     by the consulting doctor, and then be assessed by a registered Chinese medicine practitioner     for whether the illness satisfies the TCM diagnosis of the two major TCM types of URTIs:     Group A (Wind-cold syndrome) and Group B (Wind-heat syndrome). Subjects in Group A (Wind-cold     syndrome) will be randomised to receive the Jing Fan Bai Du san or placebo. Subjects in Group     B (Wind-heat syndrome) will be randomised to receive Ying Qiao san or placebo. Both group A     and B treatments and placebo will be given in sachets of granules that are identical in     appearance. Neither the Chinese medicine practitioner, the recruiting doctors, nor patient     know whether a subject is taking CHM or placebo.      328 subjects (164 in each diagnosis group) will be recruited from patients consulting the Ap     Lei Chau Government General Outpatient clinic for URTIs. Each subject is required to return     to the clinic for follow-up assessment by the Chinese medicine practitioner on day 7     post-treatment and all subjects will be contacted by telephone on Day 2, 3, 5, 9, 11, 13,15     and 20 after treatment to assess their symptoms and to find out if they have developed any     side effects or adverse reactions.      The main outcome measure is any difference in the proportion of subjects who have resolution     of the URTI on Day 7 between the treatment and placebo groups. The secondary outcome measures     are the reduction in the duration and severity of symptoms, quality of life during the     illness and side effects.      This study will provide scientific evidence to support or refute the effectiveness of two     commonly used CHM formulae in the treatment of URTIs.   "
231765|NCT00887185|"     Designed to test the efficacy of a computer based virtual simulation for teaching ear     surgery.   "
231766|NCT00887198|"     This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus     prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with     metastatic castration-resistant prostate cancer (CRPC).   "
231767|NCT00887211|"     A single blind, multi-center, randomized study is preformed to compare ProStent drug-eluting     stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to     evaluate the safety and efficacy of ProStent drug-eluting stent in treating coronary artery     lesions.   "
231768|NCT00887224|"     The primary purpose of this study is to compare the long-term efficacy and safety of     desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive     Disorder, using a randomized withdrawal design. Randomized withdrawal means that after     receiving desvenlafaxine succinate sustained release for a predetermined period of time,     subjects will be selected by chance to either continue receiving the study drug or to be     withdrawn from the study drug and receive placebo for the remainder of their participation in     the trial. Subjects will not know to which group they have been assigned.      The study consists of an up to 14-day screening period followed by an 8-week open-label     period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate     sustained release. Subjects who do not respond to treatment, demonstrating no significant     change in their depressive symptoms, will be withdrawn from participation at the end of this     period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine     succinate sustained release at the same dose. Subjects with stable response to treatment at     the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate     sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or     until symptoms of depression return. Following discontinuation at any point after enrollment     in the study, subjects will receive two weeks of follow-up monitoring, including one week of     blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any     subjects who have been taking desvenlafaxine succinate sustained release prior to     discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following     taper, subjects will be evaluated for one additional week to monitor safety.   "
231769|NCT00887237|"     Despite technological progresses the rate of non-responders to cardiac resynchronization     therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to     incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during     CRT.      One might hypothesize that stimulating the ventricles at a single site is suboptimal and that     stimulating multiple left ventricular (LV) or right ventricular (RV) sites may improve     ventricular resynchronization and, consequently, its hemodynamic and clinical effects. First     studies have suggested that 1 RV + 2 LV pacing sites configurations increased significantly     dP/dt, pulse pressure, LV end-diastolic pressure, and is associated with more LV remodeling     and better responder rate compared with pacing a single LV site. First studies with 2 RV+LV     pacing sites configuration demonstrated increased dP/dt and cardiac output and a decrease of     the cardiac dyssynchrony.      The present pilot trial was designed to examine the 6-month safety of biventricular     stimulation with 2 right ventricular (RV) and 1 left ventricular (LV) leads - main objective-     and to assess its clinical benefit.   "
231773|NCT00887289|"     The main goal of this open-label, prospective, non-controlled, non-interventional post     marketing surveillance study is to evaluate how pramipexole treatment works when applied in     actual practice. In actual practice patients who would have been excluded in the clinical     registration studies of pramipexole in moderate to severe primary Restless Legs Syndrome     (i.e. those with certain disease histories, co-morbidities and/or demographic     characteristics) will also be treated with pramipexole. Thus, during this post marketing     surveillance study additional information on the efficacy and safety of pramipexole in those     patients will be obtained. The objectives of this post marketing surveillance study are:        -  To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory          symptoms of Restless Legs Syndrome as measured with the short form of the McGill Pain          Questionnaire.        -  To assess if improvement of sensory symptoms correlates with overall Restless Legs          Syndrome severity (International Restless Legs Syndrome Scale for Severity) and with          secondary symptoms like sleeping problems and daytime tiredness (items 1 & 6 from          Restless Legs Syndrome-6).        -  To evaluate if the treatment effect of Sifrol on overall Restless Legs Syndrome severity          (International Restless Legs Syndrome Scale for Severity) differs between patients with          high pain scores and patients with lower pain scores.        -  To compare General Practitioner and neurologist sites patient populations in terms of          demographics, Restless Legs Syndrome severity at Visit 1 and treatment outcomes at Visit          3.        -  To evaluate the development of behavioural changes under pramipexole treatment.   "
231774|NCT00887302|"     This study is an investigation of the metabolics of RYGB with gastrostomy.   "
231775|NCT00887315|"     Primary goal of the study is to assess the overall survival of the addition of     hypofractionated image guided radiotherapy concurrently with Docetaxel and cisplatin.     Survival will be assessed at 1 year from the date of study enrollment to date of death.   "
231776|NCT00887328|"     The primary hypothesis being tested in this trial is that ischaemic stroke patients selected     with significant penumbral mismatch (measured by MRI criteria) at 3 - 9 hours post onset of     stroke will have improved clinical outcomes when given intravenous tissue plasminogen     activator (tPA) compared to placebo.   "
231777|NCT00887341|"     This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using     2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have     shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or     anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv     every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion     time for the first administration, followed by a 31 minute infusion time for subsequent     administrations (unless drug-related infusion reactions occur).The anticipated time on study     treatment is 3-12 months, and the target sample size is <100 individuals.   "
231778|NCT00887354|"     This study will evaluate whether teriparatide is superior to the active comparator in the     change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal     women with low bone mass and a recent pertrochanteric hip fracture.   "
231779|NCT00887367|"     This study will investigate the possible effects of alcohol in combination with GSK598809 on     the central nervous system in 20 healthy male and female volunteers, between 18 and 65 years     of age.      During 4 separate study periods subjects will receive the following treatment combinations:     Alcohol + GSK598809, alcohol + placebo drug, placebo infusion + GSK598809, and placebo     infusion + placebo drug. A placebo is a pill or liquid infusion which contains no drug or     alcohol; it is a dummy version. Therefore it is administered in the same way that either the     study drug or ethanol is depending on which placebo it is. All study drugs are administered     in a random order and both the doctor and the participant are not aware of the treatment     combination. However treatment combinations will be available at the end of the study or in     case of an emergency. GSK598809 is administered orally and alcohol is administered per     infusion. The duration of the infusion is 5 hours, during which approximately 75 grams of     alcohol is infused, which is comparable to less than one bottle of wine.   "
231780|NCT00887380|"     The purpose of this study is to determine whether starting anastrozole prior to radiotherapy,     so that it is taken during radiotherapy, decreases local recurrence of breast cancer in     post-menopausal women in comparison to waiting until after radiotherapy to commence     anastrozole.   "
231781|NCT00887393|"     Nonalcoholic Liver disease (NAFLD) is known to be caused by deposition of fat in the liver.     The impact of NAFLD on bariatric surgery is of great concern. Enlarged fatty livers increase     the operative complications of bariatric surgery and weight loss prior to bariatric surgery     has been shown to reduce complications of surgery. Most bariatric surgery programs use a     conventional low fat, calorie restricted diet during the preparation phase for surgery. The     investigators will compare the effects of the low carbohydrate versus the low fat diets on     weight loss, reduction in liver fat content, and liver size. These results will provide new     clinical insights into the optimal dietary intervention to make bariatric surgery safe and     effective for the increasing numbers of patients opting for this aggressive therapy for     morbid obesity. Patients approved for bariatric surgery by the University of Michigan     Bariatric Surgery multidisciplinary committee will be randomly assigned to either a 1000 to     1200 calorie low fat or low carbohydrate, 8-week study diet. All the food for this study will     be provided for free by the study team. Participants will be required to meet with the study     team weekly to pick up study food and for a nutritional consult. These visits will occur in     the eight weeks preceding the patient's bariatric surgery procedure. During the bariatric     surgery, a liver biopsy will be performed to assess the impact of the study diet on liver fat     content.   "
231782|NCT00887406|"     GSK961081 is a new long-acting bronchodilator being developed for the treatment of chronic     obstructive pulmonary disease (COPD). This study is the first clinical study in humans. The     purpose of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics of GSK961081 in healthy male subjects.   "
231783|NCT00887419|"     This study is for patients who have been approved by their doctors and insurance companies to     receive spinal cord stimulator implants.      The goal of this study is to investigate if pain and disability is improved in patients with     an implant in combination with coping skills training. These patients are compared with those     with an implant that receive chronic education information and those with an implant that are     in the control group and receive no additional training or information.   "
231789|NCT00887497|"     One of the major complications of surgical excision of colorectal cancer includes improper     healing of the anastomosis (reconnection of the remaining, cancer free intestine). This can     result in anastomotic leak, abscess then abdominal and/or pelvic sepsis and mortality.      Esophageal surgery has suffered from complications. Recently, an innovation in esophageal     surgery has seen a relatively drastic decrease in complications during distal esophagectomies     using a technique called ischemic conditioning. This technique involves dividing the blood     supply to the stomach that would be performed during a 1-stage esophagectomy but returning     days later to complete the resection. Bench results have shown improved angiogenesis,     vasodilation, less anastomotic collagen deposition and minimized ischemia at the time of     surgery while clinical results have included improved stricture rates, leak rates and     mortality in esophageal surgery.      Hypothesis Ischemic conditioning is universal to the intestinal tract and a similar technique     can be applied in colon and rectal surgery. The investigators plan evaluating this hypothesis     by performing a pilot study comprised of the following: performing an endovascular     embolization of the inferior mesenteric artery (IMA) followed by interval laparoscopic or     open rectosigmoid resection.      Methods Part 1 - Endovascular Procedure Patients will be admitted and undergo endovascular     embolization of their IMA as an outpatient following diagnostic angiography. They will     undergo sigmoidoscopy throughout the embolization and a laser probe will indirectly measure     tissue oxygenation. The patient will be released home that day.      Part 2 - Colorectal Procedure Patients will then return 2-4 days later for their definitive     laparoscopic or open rectosigmoid resection. They will undergo sigmoidoscopy before and after     surgery and a laser probe will indirectly measure tissue oxygenation. The patient will then     be released home on average 3-5 days later.   "
231790|NCT00887510|"     High blood pressure, also referred to as hypertension, is a blood pressure level of 140/90 mm     Hg or higher. Along with lifestyle changes, various medications are currently used to treat     people with hypertension. Some of these medications, however, may affect the way the body     handles sugar, essentially preventing the body from breaking down sugar and predisposing     people to developing diabetes. People who have metabolic syndrome—a condition primarily     characterized by an increased waist measurement, abnormal blood lipid levels, hypertension,     and high blood sugar levels—are already at risk of developing diabetes. In these people,     taking the antihypertensive medications that prevent sugar breakdown may further increase     their risk of diabetes. The purpose of this study is to gain an understanding of how people     with metabolic syndrome respond to antihypertensive medications that alter the body's ability     to break down sugar.   "
231791|NCT00887523|"     84 patients with a cup size C or more will be randomized to receive intensity-modulated     radiotherapy in supine or prone position.   "
231792|NCT00887536|"     The main purpose of this study is to learn if adding bevacizumab to standard treatment with     chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative     breast cancer will prevent breast cancer from returning. A second purpose of this study is to     learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative     breast cancer live longer. The researchers also want to learn about the side effects of the     combination of drugs used in this study.   "
231793|NCT00887549|"     Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this     research is to determine if there is a link between TS production and how well patients     respond to treatment of non-squamous non-small cell lung cancer (NSCLC). The aim for the     future is that doctors could have a better understanding in advance about which patients     might respond well to pemetrexed based on how much TS they produce.   "
231794|NCT00887562|"     The purpose of this study is to compare the efficacy of two (2) different doses of idebenone     with that of a placebo over a one month period on cerebral lactate concentration as measured     by magnetic resonance spectroscopy.   "
231795|NCT00887575|"     This trial will examine the combination of sunitinib plus paclitaxel and carboplatin as     neoadjuvant treatment for locally advanced breast cancer.   "
231796|NCT00887588|"     The study will assess the effects of 36 weeks of treatment with LCZ696 compared to valsartan     on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart     failure and preserved left-ventricular ejection fraction.   "
231797|NCT00887601|"     This study will evaluate functional magnetic resonance imaging (fMRI) and methods for     measuring drug induced changes in cerebral blood flow as biomarkers for attention-improving     drugs.   "
231798|NCT00887614|"     The purpose of this study is to determine whether participating in a Mindfulness-Based Stress     Reduction (MBSR) program increases mindful attention and awareness, and whether anticipated     changes in mindfulness relate to improved emotional well-being, sleep quality, physical     symptoms of stress, sense of spirituality, and quality of life following MBSR.   "
231799|NCT00887627|"     A study to compare a conivaptan PK in subjects with mild or moderate kidney function     impairment to subjects with normal kidney function after a 48-hour continuous infusion of     conivaptan.   "
231800|NCT00887640|"     This is a single arm study of 11 men with treatment refractory metastatic Castrate Resistant     Prostate Cancer (CRPC) who will receive temsirolimus IV at a dose of 25 mg weekly until     progression. Progression will not include Prostate Specific Antigen (PSA) progression;     however, upon PSA progression, the addition of an anti-androgen will be permitted. The     primary objective of the study is to evaluate change in circulating tumor cell (CTC) counts     over time in men with metastatic treatment-refractory CRPC in response to temsirolimus     therapy.   "
231820|NCT00887913|"     The purpose of this study is to determine whether the Matrix RF applicator is effective in     the treatment of facial skin texture and wrinkle reduction.   "
231801|NCT00887653|"     The success of combination antiretroviral therapy heralded a revolution in the treatment of     HIV in the mid-1990s. However, severe treatment-associated side effects have been observed     including diabetes and increased cholesterol which are linked to premature heart attacks.     This effect has been described among many regimens containing protease inhibitors (PIs), as     well as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Raltegravir is a new     medicine which has been shown to be potent and efficacious in suppression of the HIV. This     study hopes to determine if switching from a PI or NNRTI to raltegravir will decrease     cholesterol in subjects with high cholesterol and well controlled HIV. In addition, the study     aims to confirm that raltegravir is safe and well tolerated. It also seeks to confirm if     raltegravir will have similar anti-HIV activity compared with the patient's previous regimen.      The study will last 6 months and will involve 20 subjects. HIV-1 infected men and women on     PIs or NNRTIs for at least 12 months before study entry with well controlled HIV will be     recruited.      Hypotheses:        1. Patients with elevated lipid levels while on combination antiretroviral therapy with PIs          or NNRTIs will experience an improvement in lipid levels after switching their PI or          NNRTI to a raltegravir based regimen.        2. Raltegravir will be safe and well tolerated.        3. Raltegravir will have similar antiretroviral activity compared with the prior regimen.      Primary Objective:      To demonstrate an improvement in lipid profile (triglycerides or LDL) in subjects switched to     raltegravir from PIs or NNRTIs at 2, 3, and 6 months after study entry.      Study Design: Subjects will be given the option to switch from their current regimen to     raltegravir at 400mg twice daily. Those who consent, will receive raltegravir provided by the     study for 6 months. At entry, the subjects will undergo a complete physical exam and     thereafter targeted exams at each visit. Labs will be drawn as part of clinical care at 2, 3,     and 6 months. Some of the blood will be stored for later analysis. Also, the subjects will     answer regular surveys on drug toxicity and quality of life. Their cholesterol level will be     compared before and after the study. At the end of the study, the participants may choose to     continue on raltegravir if they desire.   "
231802|NCT00887666|"     People with heart failure may have low magnesium and low vitamin D levels. They may also have     abnormally high levels of parathyroid hormones. Magnesium and vitamin D are important     chemicals that are not routinely measured in blood tests. We are studying how many people     with heart failure have low levels of magnesium and vitamin D. We are also studying how many     people with heart failure have overactive parathyroid glands and if that is related to their     vitamin D levels.   "
231803|NCT00887679|"     The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and     effective in the treatment of HIV-infected patients with generalized anxiety disorder.   "
231804|NCT00887692|"     10 patients will be treated alternating daily between prone and supine position for breast     radiotherapy to compare set-up accuracy. Prone treatment will be given on the odds days and     supine treatment on the even days.   "
231805|NCT00887705|"     ADL training of copd patients results in better execution of activities of daily living.   "
231806|NCT00887718|"     This study examines the role of a diagnostic test called Positron Emission Tomography (PET)     scanning in patients with malignant lymphoma. The primary goal of this study is to find out     how well PET scanning can detect malignant (cancerous) lymphoma, and how often this extra     information will result in a change of stage of disease, or will result in a change in     treatment management plans of patients with lymphoma.   "
231807|NCT00887731|"     Nearly forty years ago Berran and coworkers tested an analog oxygen controller to maintain     incubator oxygen levels for infants suffering neonatal respiratory disease in order to     prevent hyperoxia.      There are at least three clinical issues that this technology addresses: the first is     avoidance of episodic hyperoxia; the second is decreasing episodic hypoxia; and the third is     lowering cumulative oxygen exposure.      Clinical trials which have used target SpO2 ranging probably help improve all of these     problems, but so far there have been no direct measurements of continuous arterial oxygen     levels, nor clinical studies which establish the degree to which improving control over blood     oxygen saturation decreases the cumulative amount of oxygen exposure. This study will address     the later and is an important step in the process of incorporating closed-loop oxygen control     technology as a routine standard of neonatal respiratory care.      OBJECTIVES:      PART 1: Test and modify the instruction set for the computerized oxygen controller to achieve     a goal of less than six (6) operator required interruptions per hour for oxygen saturation     deviations outside of study guidelines.      PART 2: Perform a within patient cross-over trial of the computerized oxygen controller     versus standard of care (the patient's care team adjusts the patient's oxygen level) and     evaluate the area under the time curve for oxygen exposure between the two control methods.      PART 3:(After successful completion of PART 2) Continuation of the within patient cross-over     study with a randomized cross-over sequence. Studies will last 4 to 12 hours divided in two     (2) equal time blocks with one cross-over to either automatic or manual control modes.     Provision for up to an additional twenty (20) patients to be studied.   "
231808|NCT00887744|"     The primary purpose of the study is to measure the change in severity of symptoms and ability     to function in every day activities in patients suffering from degenerative lumbar spinal     stenosis after treatment with the Aperius® device.   "
231809|NCT00887757|"     This is a Phase 1 open-label study evaluating the safety of navitoclax (ABT-263) when     combined with a standard regimen of gemcitabine in approximately 50 subjects with solid     tumors and measurable disease.   "
231810|NCT00887770|"     This study is being performed to investigate the potential for AZD5672 to affect the     electrical conduction pathways in the heart. AZD5672 will be compared against a drug     (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the     electrical conduction of the heart.   "
231811|NCT00887783|"     This study is an open label randomized multi-centre phase II trial in patients with     inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general     criteria for curatively intended irradiation. The treatment plan consists of two courses of     inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day     1 of the last induction chemotherapy has been given. The patients will be included in the     study after completing the induction chemotherapy. Randomization will take place only if an     acceptable dose plan can be obtained.   "
231812|NCT00887809|"     The purpose of this study is to test whether an experimental drug called bevacizumab given     together with gemcitabine and docetaxel, a standard chemotherapy regimen for sarcoma, can     help sarcoma patients. This trial will examine what effects, good and/or bad the combination     of gemcitabine, docetaxel and bevacizumab has on sarcoma.   "
231813|NCT00887822|"     This 2 arm study will compare the efficacy and safety of bevacizumab in combination with     capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in     participants who have not received prior chemotherapy for advanced or metastatic gastric     cancer. Participants will be randomized to one of two treatment groups Bevacizumab +     Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm).   "
231814|NCT00887835|"     The purpose of this study is to utilize the PERPOS™ PLS System for transfacet lumbar spine     fixation to evaluate its effect on patients' level of pain, procedural complications and     functional status.   "
231823|NCT00887952|"     The aim of this multicenter randomized controlled clinical trial is to evaluate the     effectiveness of an alternative treatment for deep caries lesions in Public Health Services.     The alternative treatment consists of partial removal of carious dentine followed by     restoration. The subjects were assigned to test or control groups: test - carious dentine     partial removal and restoration in one session, and control - stepwise excavation. The     stepwise excavation consists of partial removal of carious tissue from the cavity floor,     indirect pulp capping with calcium hydroxide cement; temporary filling; cavity re-opening     after 60 days, removal of the remaining soft carious tissue and filling. Each group was     divided according to the filling material: amalgam or resin. The radiological exams are being     performed before and after the treatment and then annually. Clinical evaluation of the     restorations is performed right after the treatment and then annually (modified USPHS     System). All evaluations are performed by calibrated and trained dentists.   "
231941|NCT00888186|"     The purpose of this study is to study different kinds of dyskinesias in advanced Parkinson's     disease appearing at different levels of levodopa infusion dose. The hypothesis is that     different dyskinesias (dystonia, chorea) correlate to different levels of levodopa     concentrations, as detected in plasma.   "
231824|NCT00887965|"     To characterize the effects of discontinuation of denosumab therapy on variables of bone     histology in postmenopausal women with low bone mass or osteoporosis. Patients who have     received denosumab and completed study 20050179 (NCT00293813), completed study 20050141     (NCT00330460), completed study 20060237 (NCT00515463), completed study 20030216 (NCT00089791)     but did not enroll in study 20060289 (NCT00523341) will be included in this study. Patients     who will participate in the off-treatment imaging study for 20080747 (NCT00890981) are also     eligible.   "
231825|NCT00887978|"     This study is an international, multi-center, randomized, double-blind, placebo-controlled     study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e.,     endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur     at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk     test. Study procedures include routine blood tests, medical history, physical exams, disease     evaluation, and exercise tests.      Patients who complete all assessments for 16-weeks will also be eligible to enter an     open-label, extension phase study (FREEDOM - EXT).   "
231826|NCT00887991|"     This is a randomised controlled trial investigating the performance of two, 'state of the     art' electric breast pumps in mothers who have delivered preterm infants. The main data     collection period will be up to day 10 post delivery data. Data collected will include a     record of the weight of milk produced during the first 10 days and a short questionnaire to     find the mothers' opinions of the pumps used. On Day 5 a timed and weighed expression of 15     minutes will be carried out. After the first 10 days, mothers will be asked to collect brief     information on their continuing use of their pumps and subsequent duration of breast and     bottle feeding, mothers will be contacted at 3 and 6 months post-term   "
231827|NCT00888004|"     This study will evaluate the safety and efficacy of administration of AFQ056 in combination     with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease     patients.   "
231828|NCT00888017|"     Previous research studies have shown that there may be a connection between proton pump     inhibitor therapies and hip fracture in adults(1). Proton pump inhibitor(PPI) reflux     medications raise the pH of the stomach, which may effect the body's ability to absorb     certain calcium compounds.      Neonates are at a crucial age for bone mineralization. Because esophageal reflux is common in     neonates, PPI therapy is commonly used, despite little information on effectiveness and side     effects. PPIs work by blocking the production of protons in the pumps in the stomach, thus     making the stomach less acidic. The calcium ion needs an acidic environment in order to be     broken down from its natural compounds into an absorbable form (2). This is troubling because     of the problems associated with osteopenia in neonates. Bone mineralization is important for     premature infants. Rickets and bone fractures are higher in preterm infants than term     infants. For this reason, we are investigating whether there is a connection between PPI     therapies (specifically Prevacid) and decreased bone densities in neonates.      The objective is to determine if a connection exists between proton pump inhibitor antacids     and decreased rate of bone mineralization in neonates.   "
231829|NCT00888030|"     End-stage renal disease is a global epidemia with an estimated incidence of 7% per year and     high morbidity-mortality rate. Early detection of chronic kidney disease (CKD) and     intervention for CKD complication is important to retard renal progression. However,     traditional uremic toxin or small water-soluble molecules are poorly correlated with the     renal function, uremic symptoms and outcomes of CKD patients.      Putative protein-bound solute, p-cresol, is accumulated in ESRD patients receiving dialysis     therapy. This uremic solute was associated with endothelial dysfunction, immune dysregulation     and can predict outcome in hemodialysis patient. P-cresol inhibits endothelial cell     proliferation and endothelial response to inflammatory cytokines. In vitro, p-cresol     decreases leukocyte transendotherliar migratory function and inhibit production of phagocyte     reactive species. Clinically, p-cresol plays a pathophysiological role in the uremic     toxicity. High free serum level of p-cresol is associated with mortality in hemodialysis     patients.      Information of p-cresol in CKD patients is not available. The investigators hypothesized     p-cresol can be accumulated in early CKD and have a positive correlation with the morbidity-     mortality of CKD patients.      Value of p-cresol in different stages of CRF is still unknown. Information of p-cresol in CKD     patients is not available. The investigators hypothesized p-cresol can be accumulated in     early CKD and have a positive correlation with the morbidity- mortality of CKD patients.      The principal aim of this prospective cohort study is to investigate the association between     total serum levels of p-cresol and the glomerular filtration rate. The correlation of level     of p-cresol and morbidity-mortality in CKD patients will be also evaluated.      To determine the relationship, patients of nephrology clinic with a diagnosis of CKD were     enrolled in this prospective study and follow-up for 1-year period. The association between     total and free serum levels of p-cresol and the glomerular filtration rate were evaluated in     CKD patients. The p-cresol level was correlated with other many inflammatory markers (white     blood cell counts, ferritin, hs-crp, leptin) and also with the hospitalization rate secondary     to cardiovascular and infectious event. The renal outcome and all-cause mortality was     assessed. Determination of this relationship can help to establish an accurate marker for     early detection of CKD and also its prognostic role in CKD patients.   "
231830|NCT00888043|"     The purpose of this research study is to find out what side effects the combination of the     two study drugs, bevacizumab (Avastin) and CNTO 95 have on the body and to determine the     highest dose of CNTO 95 that can be given with bevacizumab that is safe and well tolerated.   "
231849|NCT00881478|"     Obesity in children is a serious disease that is associated with increased mortality and     decreased life expectancy. A simple tool used to assist in controlling portions (and     therefore calorie intake) at mealtime would be of benefit in promoting weight maintenance     and/or loss. The purpose of this study is to assess the efficacy of a family intervention     using a portion control tool to help control weight in obese children. The investigators     hypothesize that the use of portion control tools by the parents and child will result in a     greater decrease in the child's BMI over a 6 month period compared with the control group.   "
231850|NCT00881491|"     The purpose of this study is to determine the treatment outcomes in permanent teeth with     necrotic pulp and immature root development that undergo a regenerative procedure using a     triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double     antibiotic paste (ciprofloxacin, metronidazole)compared to the commonly used mineral trioxide     aggregate (MTA) apexification treatment.   "
231851|NCT00881504|"     This study is for patients with biliary tract cancer that has spread and who are not     candidates for surgical resection.      The purpose of this research is to determine if bevacizumab can be safely administered with     Modified FOLFOX 6 and find out what effects, good and/or bad, this type of treatment has on     biliary cancer.      In this study, a combination of chemotherapy, Modified FOLFOX6 and a biologic agent,     bevacizumab will be tested.      Subjects on this study will receive chemotherapy and bevacizumab every 2 weeks until their     disease gets worse or they are unable to tolerate treatment.   "
231852|NCT00881517|"     The aim of this trial is to verify, under controlled conditions, the reported efficacy of     human cytomegalovirus (HCMV)-specific hyperimmune globulin administration to pregnant women     suffering from primary HCMV infection for the prevention of intrauterine HCMV transmission.   "
231831|NCT00888056|"     Alzheimer's Disease (AD) is the most common cause of dementia for which no treatment has     shown consistent efficacy to stop or slow down the disease. Recent report of enhancement of     memory abilities by bilateral chronic deep brain stimulation (DBS) of the fornix in the     hypothalamus suggests that neuromodulation of circuits involved in memory processes may have     therapeutic implications in AD patients with memory decline.      The primary objectives of this prospective, non-controlled, pilot study are to evaluate the     feasibility and safety of DBS in AD patients with mild cognitive and memory impairment, and     to evaluate the efficacy of DBS to slow down or stabilize this decline. Five patients with AD     (DSM IV) diagnosed less than two years, with mild cognitive decline (MMSE 20-24), and     specific impairment of episodic memory will be included in a 2-year period. The evaluation     criteria for feasibility will be the proportion of patients undergoing the procedure, chronic     stimulation and evaluation process without adverse event (AE). Efficacy will be evaluated     using numerous cognitive and memory testing. Changes in behavioral and mood scales, and     changes in hypothalamic functions (clinical, biological and hormonal assessment) will     evaluate safety and tolerance. Clinical, neuro-psychological, biological and imaging     assessment will be performed 3 and one month before and 3, 6, 12 and 24 months after surgery.     Bilateral electrodes (Medtronic 3389) will be implanted, by MR-guided frame-based stereotaxy,     in the hypothalamic part of the fornix, and then connected to the generator (Kinetra,     Medtronic). Chronic high-frequency stimulation will be delivered immediately after surgery.      The investigators expect to slow down, or to stabilize the spontaneous decline of MMSE and     ADAS scores after 6, 12 and 24 months of stimulation. In case of efficacy, DBS might offer to     AD patient the possibility to slow down/stabilize their symptoms, which no other treatment     can currently offer, and to increase their quality of life.   "
231832|NCT00888069|"     This study will investigate how the levels of a single dose of CTAP101 changes in the body     over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances     (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with     vitamin D insufficiency and secondary hyperparathyroidism (SHPT).   "
231833|NCT00881270|"     Primary Objective:      To prove the safety of the formulation in normal conditions of use.   "
231834|NCT00881283|"     The purpose of this study is to determine whether subjects who have been affected by     Cushing's disease in the past maintain some different characteristics compared with subjects     who have never been diagnosed with the disease.   "
231835|NCT00881296|"     A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly     gemcitabine in elder patients (> 75) with previously untreated advanced non-small cell lung     cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST     criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly     single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (>     76 years) who have received no prior treatment for non-small lung cancer. As secondary     objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin     combination chemotherapy, progression-free survival and overall survival will be evaluated in     both patients with biweekly gemcitabine and carboplatin combination chemotherapy and weekly     single gemcitabine.      The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus     carboplatin may improve the efficacy.   "
231836|NCT00881309|"     The purpose of this study is to:        -  To access the efficacy of TW compared to Aza in the maintenance therapy for lupus          nephritis        -  To investigate the safety and tolerability of TW versus Aza in the maintenance therapy          for lupus nephritis   "
231837|NCT00881322|"     This is a randomized, double-blind, placebo-controlled trial to determine the safety and     efficacy of Digestive Advantage™ Gas Defense formula, a probiotic dietary supplement. The     study will last approximately four weeks, and subjects will be seen at a     screening/randomization visit, and two follow-up visits.      Study procedures will include administering questionnaires for assessment of the study     product's effect on intestinal gas symptoms and quality of life.   "
231838|NCT00881335|"     The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus     clearance devices in elders of gerocomium.   "
231839|NCT00881348|"     Primary Objective:      To demonstrate the absence of photo irritation and photosensitization potential of the     product Dermacyd Infantile (Lactic Acid).   "
231840|NCT00881361|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs     to be removed.      PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and     axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage     IIIB breast cancer.   "
231841|NCT00881374|"     Primary Objective:      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated     dermic irritability) and allergic potential (sensibilization) of the product Dermacyd     Infantile.   "
231842|NCT00881387|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as     gemcitabine and vinorelbine, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Giving rituximab together with     gemcitabine and vinorelbine may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving rituximab together with gemcitabine     and vinorelbine works in treating patients with Hodgkin lymphoma that has relapsed or not     responded to treatment.   "
231843|NCT00881400|"     To demonstrate the relative bioavailability of Cefzil 250 mg/5 ml oral suspension fed     conditions.   "
231844|NCT00881413|"     The aim of this study is to compare the clinical effectiveness of intravenous esomeprazole     and pantoprazole in preventing recurrent bleeding in the patients with high-risk bleeding     peptic ulcers after successful standard endoscopic hemostasis.   "
231845|NCT00881426|"     To demonstrate the relative bioavailability of Cefzil 500 mg Cefprozil tablets under fasting     conditions.   "
231846|NCT00881439|"     The main purpose of this study is to examine the effect of add-on therapy with the direct     renin inhibitor Aliskiren in comparison to placebo on renal blood flow in patients with heart     failure and reduced renal function.        -  Primary outcome measure: change in renal blood flow at 6 months        -  Secondary outcome measures: changes in renal function, N-terminal pro Brain natriuretic          peptide, left ventricular function, blood pressure and neurohormones   "
231847|NCT00881452|"     The purpose of this study is to determine whether CM-AT is safe and effective in treating the     core symptoms of autism.   "
233777|NCT00907439|"     The purpose of this study is to determine the effect of inhaled anesthetic drugs upon     diastolic heart function (heart suction and filling performance) in patients who are     undergoing coronary bypass surgery.   "
231855|NCT00881556|"     Reduced Intensity Conditioning (RIC) and Allogeneic Stem Cell Transplantation (AlloSCT) from     family-related donors and unrelated cord blood (UCB) donors will be safe and well tolerated     in selected patients with RDEB.      To determine the event-free survival (EFS) and overall survival (OS) following RIC consisting     of busulfan/fludarabine/alemtuzumab (BFA) and AlloSCT in selected patients with RDEB.   "
231856|NCT00881569|"     This is a study of CS-7017 designed to allow subjects who completed participation in a     clinical study of CS 7017 without experiencing disease progression or unacceptable toxicity     to continue treatment with study drug. Subjects who have not progressed while receiving     CS-7017 will continue to benefit from longer administration of the agent.   "
231857|NCT00881582|"     There is a distinct lack of published literature on the effect of combination treatment of     PEG-interferon and ribavirin on post-renal transplantation hepatitis C virus (HCV) patients.     Small case series have been published utilizing conventional interferon and/or ribavirin and     the available data is extremely preliminary in nature. A small retrospective series of     patients treated with Pegylated interferon and ribavirin published recently suggests that the     treatment may be safe and efficacious. Unpublished reports from a few centers within Saudi     Arabia also suggest a good safety profile and reasonable efficacy from this form of     combination treatment.      The investigators aim to prospectively study the safety and efficacy of PEG-interferon and     ribavirin combination therapy in post-renal transplant HCV-infected patients. Towards this 40     patients with histological evidence of liver disease will be recruited and the efficacy of     the above medications studied.      The proposed study aims to evaluate the efficacy and safety of PEG-interferon and ribavirin     combination therapy in the treatment of chronic HCV in renal transplant patients in a way     that will allow management of such patients in an optimized manner.   "
231858|NCT00881595|"     The goal of this study is to evaluate the effects of temozolomide and radiation combination     in the treatment intended of soft tissue sarcomas.      This study will also look at the tumor tissue that was removed during your initial biopsy and     your final surgery for information that may help to treat soft tissue sarcoma in the future.     In addition the investigators will examine a sample of your normal tissue (optional) from the     inside of your mouth/cheek (to compare it to your tumor tissue) before starting treatment.   "
231859|NCT00881608|"     The purpose of this study is to determine the oral dose level at which the investigative     drug, Proellex, is able induce menstruation.   "
231860|NCT00881621|"     Patients are being asked to participate in this study who have locally advanced or metastatic     pancreatic cancer (cancer of the pancreas that has spread to another part of the body) that     has gotten worse after first-line chemotherapy.      The purpose of this study is to see if the drugs, Capecitabine and Lapatinib (two     chemotherapy agents), prolong survival and improve quality of life as compared to supportive     care alone.      Lapatinib in combination with a drug called capecitabine, has been approved by the Food and     Drug Administration (FDA) for the treatment of metastatic breast cancer. It has not yet been     approved to treat this type of cancer. Both of these drugs are pills.      This research is being done because it is not known if the combination of Capecitabine and     Lapatinib is better than supportive care alone for pancreatic cancer.   "
231861|NCT00881634|"     To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine     Hydrochloride 5 mg/120 mg ER tablets under fed conditions.   "
231862|NCT00881647|"     This study will test the effectiveness of cognitive behavioral therapy for insomnia in     treating sleep disturbances in people with post-traumatic stress disorder.   "
231863|NCT00881660|"     Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and     leaves a portal through which abdominal structures can migrate into the thorax. In the more     severe cases, the abdominal structures remain in the thoracic cavity and compromise the     development of the lungs. Infants born with this defect have a decreased capacity for gas     exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be     accurately diagnosed by mid-gestation, a number of strategies have been developed to repair     the hernia and promote lung tissue development.      Fetal tracheal occlusion is one technique that temporarily closes the herniated area with the     Goldvalve balloon to allow the lungs to develop and increase survival at birth. This is a     pilot study of a cohort of fetuses affected by severe CDH that will undergo FETO to     demonstrate the feasibility of performing the procedure, managing the pregnancy during the     period of tracheal occlusion, and removal of the device prior to delivery at BCM/Texas     Children's Hospital (TCH). It is anticipated that fetal tracheal occlusion plug-unplug     procedure will improve mortality and morbidity outcomes as compared with current management,     but this is not a primary endpoint of the feasibility study. We will perform 20 FETO     procedures on fetuses diagnosed prenatally with severe and extremely severe CDH.   "
231864|NCT00881673|"     The purpose of the study is to determine whether Al38583 Ophthalmic Solution is safe and     effective in reducing tear eosinophil levels at 5-8 hours after Conjunctival Allergen     Challenge (CAC).   "
231867|NCT00881712|"     The purpose of this study is to find out what effects, good and/or bad, proton radiation at a     higher tumor dose (and lower normal surrounding lung dose) combined with standard     chemotherapy has on lung cancer. The dose you receive to the tumor will be higher than the     standard dose. This may be able to increase the control of the tumor. Due to the accuracy of     radiation given with protons, the dose to the normal lung tissue that surrounds the tumor     will be lower than standard. This may be able to reduce the frequency and severity of the     usual radiation side effects.   "
231868|NCT00881725|"     This study will investigate the effect of neoadjuvant metformin therapy in the inhibition of     growth and proliferation of prostate cancer cells prior to radical prostatectomy.   "
231869|NCT00881738|"     To demonstrate the relative bioavailability of Clarithromycin 250 mg tablets under fasting     conditions.   "
231900|NCT00882141|"     The purpose of this study is to test the hypotheses that there are ethnic and genetic     differences in the mechanisms and magnitude by which hypocaloric weight loss and aerobic     exercise affect body composition, glucose, lipid, muscle and adipose tissue metabolism in     overweight, insulin resistant postmenopausal women. This will be tested in a trial comparing     the effects of weight loss vs. aerobic exercise plus weight loss on glucose, lipid, fat and     muscle metabolism in overweight African American and Caucasian postmenopausal women.   "
231870|NCT00881751|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Erlotinib and sorafenib may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Bevacizumab, erlotinib, and sorafenib may also stop the growth of tumor cells by blocking     blood flow to the tumor. It is not yet known whether giving bevacizumab together with     erlotinib is more effective than giving sorafenib in treating patients with liver cancer.      PURPOSE: This randomized phase II trial is studying how well giving bevacizumab together with     erlotinib works compared with sorafenib as first-line therapy in treating patients with     advanced liver cancer.   "
231871|NCT00881764|"     The purpose of this study is to determine whether the use of anesthetic agents in infants and     children have long term adverse effects on neurocognitive development. According to the     National Hospital Discharge Survey, around 2.5 million children have surgical procedures     requiring anesthesia each year in the US. Recent animal studies have suggested that the     exposure of the immature organism to a variety of commonly used anesthetic agents may lead to     neurobehavioral functional deficits in vivo and to neuronal apoptosis in vitro. While the     relevance of these findings on children exposed to anesthetics remains to be determined, it     is clearly critically important to public health that this issue is resolved quickly and     clearly.      Hypothesis: Exposure to anesthetic agents within the first three years of life will not     significantly impair cognitive functions at ages 8 yr, 0 mo to 15 yr, 0 mo.   "
231872|NCT00881777|"     The purpose of this study is to examine the safety and potential effectiveness of a new     surgical procedure for treating heart failure. The experimental treatment is performed during     standard coronary artery bypass graft (CABG) surgery, and applies radiofrequency energy to     heat a portion of the damaged heart muscle. The tissue heating reduces the enlarged heart of     patients suffering from ischemic heart failure, and may result in the heart pumping blood     more efficiently, thereby improving the functional status of the patient.   "
231873|NCT00881790|"     The behaviour of 12 dental nurses seeing 600 nursery school children in East Scotland will be     video-taped to determine the interaction patterns adopted by the staff in the application of     a fluoride varnish to the surfaces of the child's teeth. The aim is to test the benefit of     certain communication strategies used by the nurses to affect an efficient application     controlling for nursery school site, age of child and experience of dental nurse.   "
231874|NCT00881803|"     Iron overload is a life-threatening condition that can lead to liver disease, cardiac     disease, diabetes and arthritis. Simultaneous supplementation with both iron and AA may place     individuals with SCI at risk for iron overload as well as oxidative damage by iron-generated     free radicals. Both conditions of high and low iron stores may present with common signs and     symptoms. Accurate diagnosis of iron disorder should consider CRP, hematocrit, hemoglobin,     serum iron, TIBC, percent saturation of iron binding capacity, serum ferritin and hepcidin.      The investigators are proposing a study to determine the effect of concurrent AA and iron     supplementation on iron status of individuals with SCI. The investigators goal is to identify     abnormal status that may be attributed to simultaneous supplementation of iron and AA to     develop future supplementation protocols in this population for optimal iron status.   "
231875|NCT00881816|"     The purpose of this study is to determine the maximum tolerated dose and dose limiting     toxicity of liposomal paclitaxel plus capecitabine in Chinese patients with advanced gastric     carcinoma.   "
231876|NCT00881829|"     The purpose of this study is to evaluate the SpO2 accuracy and performance of the Oxitone     Medical Oxitone 1000 pulse oximeter during non-motion conditions over the range of 70-100%     SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation.      This study is observational in nature which quantifies device performance and accuracy in     comparison to a Reference Standard.   "
231877|NCT00881842|"     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of     these vaccines are required to be involved in ongoing clinical trials and to present the     results to the competent authorities each year. The current study is a phase IIIa clinical     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It     is part of the ongoing clinical trial program for Influvac® and will be done to assess the     immunogenicity and safety and tolerability of next season's trivalent influenza subunit     vaccine in two groups of subjects in good health: subjects aged >= 18 and <= 60 years and     subjects >= 61 years of age (elderly).   "
231878|NCT00881855|"     The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 500 mg     Cefprozil Tablets Under Fed Conditions.   "
231879|NCT00881868|"     The primary objective of this study is to evaluate the safety and efficacy of clobetasol     propionate spray versus vehicle spray for the management of moderate to severe plaque     psoriasis of the scalp.   "
231880|NCT00881881|"     This is an epidemiological, multicenter, retrospective study to analyze the management of     rheumatoid arthritis (RA) in usual clinical practice in Spain. Two groups of patients will be     analyzed: individuals who have had RA for two years or less (the early RA group) and     individuals who have had RA for more than 2 years and who currently meet the ACR criteria for     RA (the established RA group).   "
231881|NCT00881894|"     The major aim of this study is to investigate and compare the drug amount delivered to the     body after sequential application of 2 rotigotine transdermal patches from 2 different     manufacturing processes.   "
231882|NCT00881907|"     The purpose of the investigators study is to characterize the composition of the hard and     soft tissues present in root canals of teeth previously diagnosed with necrotic pulps and     incomplete root formation and treated with a triple antibiotic regeneration protocol. The     investigators hypothesis is that treatment of teeth with necrotic pulps and immature apices     with triple antibiotic paste will stimulate continued root formation by the deposition of     dentin at the root apices. The primary outcome measure will be histological identification of     mineralized tissue and adherent cells in the apical third of these teeth.   "
231901|NCT00882154|"     To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed     conditions.   "
232057|NCT00889837|"     The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine     within a day in patients with COPD.   "
231883|NCT00881920|"     Patients have a type of cancer called NHL, Multiple Myeloma (MM) or CLL. The lymphoma, MM or     CLL has come back or has not gone away after treatment. There is no standard treatment for     the cancer at this time or the currently used treatments do not work completely in all cases     like these. This is a gene transfer research study using special immune cells.      The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancers. This research study combines two different ways of fighting disease,     antibodies and T cells, that investigators hope will work together. Antibodies are types of     proteins that protect the body from bacterial and other diseases. T cells, also called T     lymphocytes, are special infection-fighting blood cells that can kill other cells, including     tumor cells. Both antibodies and T cells have been used to treat patients with cancers; they     have shown promise, but have not been strong enough to cure most patients.      T lymphocytes can kill tumor cells but there normally are not enough of them or they are not     able to kill all the tumor cells. Some researchers have taken T cells from a person's blood,     grown more of them in the laboratory and then given them back to the person.      The antibody used in this study recognizes a protein on the lymphoma, MM or CLL cells called     kappa immunoglobulin. Antibodies can stick to lymphoma, MM or CLL cells when it recognizes     the kappa molecules present on the tumor cells. For this study, the kappa antibody has been     changed so that instead of floating free in the blood it is now joined to the T cells. When     an antibody is joined to a T cell in this way it is called a chimeric receptor. These     chimeric receptor-T cells seem to kill some of the tumor, but they don't last very long and     so their chances of fighting the cancer are limited.      In the laboratory, investigators found that T cells work better if they also add a protein     that stimulates T cells to grow called CD28. By joining the anti-kappa antibody to the T     cells and adding the CD28, the investigators expect to be able to make cells that will last     for a longer time in the body (because of the presence of the CD28). They are hoping this     will make the cells work better.      Previously, when patients enrolled on this study, they were assigned to one of three     different doses of the kappa-CD28 T cells. We found that all three dose levels are safe. Now,     the plan is to give patients the highest dose that we tested.      These chimeric T cells (kappa-CD28) are an investigational product not approved by the FDA.   "
231884|NCT00881933|"     Severe aplastic anemia is a fatal disease and patients without HLA matched siblings need     alternative treatment option. Cord blood transplantation (CBT) has become an alternative     treatment means in various diseases, but it has not been proved to be good for severe     aplastic anemia. Double units CBT is proposed to have better engraftment potential and and we     reported successful double units UCBT after engraftment failure with single unit with     promising result. To increase the engraftment potential, fludarabine, cyclophosphamide plus     TBI conditioning regimen for double units cord blood transplantation was proposed for the     patient with severe aplastic anemia without HLA-matched donor.   "
231885|NCT00881946|"     The purpose of this study is to characterize the safety and tolerability of repeat doses of     compound GSK2110183 in subjects with hematologic cancer.   "
231886|NCT00881959|"     The purpose of the study is to evaluate whether clinical parameters for Puros Dermis are, at     minimum, equivalent when compared to AlloDerm, the current industry standard, for the     treatment of single, non-adjacent Miller's Class I or II gingival recession.   "
231887|NCT00881972|"     This study will test the effects of daily physical activity on variations in blood glucose     control.   "
231888|NCT00881985|"     The objectives of this study are to investigate the effect of continuous positive airway     pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects     with resistant hypertension and moderate obstructive sleep apnea (OSA).   "
231889|NCT00881998|"     A prospective, comparative, randomized single surgeon study comparing minimally invasive     total hip arthroplasty (MIS) via anterior approach to conventional total hip arthroplasty via     anterolateral transgluteal approach.   "
231890|NCT00882011|"     The purpose of the study is to create a prospective database of T-Lymphoblastic Lymphoma     (T-LBL) cases in order to conduct an appropriate statistical study as well as to monitor     diagnosis and minimal residual disease (MRD), to detect specific genetic profile useful to     give advices on therapies, to assess if PET has a prognostic validity on T-Lymphoblastic     Lymphoma (T-LBL).   "
231891|NCT00882024|"     The purpose of this study is to evaluate whether tranilast at two different dosages compared     to placebo is effective in patients with active RA when added to continuing methotrexate     (MTX) therapy.   "
231893|NCT00882050|"     The purpose of this project is to study if intravenous Exenatide is effective at maintaining     normal blood glucose levels and preventing low blood glucose levels during surgery.   "
231894|NCT00882063|"     The purpose of this study is to determine safety of P276-00 in patients with advanced     multiple myeloma and whether P276-00 is effective in the treatment of advanced cases of     multiple myeloma.   "
231895|NCT00882076|"     The purpose of this study is to establish toxicity and a maximum tolerated dose recommended     phase 2 dose of Clofarabine in combination with Etoposide and Mitoxantrone for therapy of     relapsed or refractory acute leukemias. The investigators will observe responses with these     therapy agents and assess the impact of Clofarabine interacting with Etoposide in induction     of DNA strand breaks.   "
231896|NCT00882089|"     The purpose of this study is to determine if a Contura catheter can avoid a radiation hot     spot in the skin and improve tissue-balloon conformance in early-stage breast cancer     patients undergoing accelerated partial breast irradiation.   "
231897|NCT00882102|"     The goal of this clinical research study is to learn if 5-aza-2 deoxycytidine (decitabine)     given in combination with Mylotarg (gemtuzumab ozogamicin) can help to control Acute myeloid     leukemia (AML), high-risk myelodysplastic syndromes (MDS) or Myelofibrosis (MF). The safety     of this drug combination will also be studied.   "
231923|NCT00882453|"     The purpose of this observational study is to obtain a survey on physical activity in     patients who for the first time have experienced symptoms which indicate a high risk for     developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain     information on factors potentially influencing the patients' level of activity.   "
231898|NCT00882115|"     Allergic airway disease is a term used to describe conditions such as allergic rhinitis and     asthma. Among other causative agents, air pollutants and diesel exhaust in particular, have     been shown to create and also worsen existing allergic airway disease. These inhaled     pollution particles have oxidative properties that drive inflammation-related effects through     specific metabolic-associated processes. These processes are not adequately suppressed by     current therapeutics. The purpose of this study is to explore the effects of broccoli sprout     extract on the inflammatory process in the nose caused by diesel exhaust particles, which are     important elements in air pollution. Broccoli sprout extract is a very potent inducer of     Phase II enzymes (natural antioxidants).   "
231899|NCT00882128|"     To evaluate the level of control of Asthma (GINA : controlled, partially controlled, not     controlled) of asthmatic patients consulting their general practitioner for a seasonal     increase of respiratory symptoms (high and / or low) whether an inhaled corticotherapy is     taken or not.   "
232529|NCT00896961|"     This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft     tissue sarcoma or mouth cancer. Using the drug EF5 to measure the oxygen level in tumor cells     may help in planning cancer treatment   "
231902|NCT00882167|"     Official title:      Sensitivity and predictive value of functional cine magnetic resonance imaging (MRI)     detecting intra-abdominal adhesions      Background:      Adhesions are a frequent problem in abdominal surgery. The formation of adhesions is part of     a normal wound healing. However in some patients adhesions cause severe complications such as     chronic pain, obstruction and strangulation of the bowel. Adhesions can also obstruct access     to the peritoneal cavity and complicate reoperations. Accurate imaging of adhesions would be     of benefit avoiding adhesion related complications at repeated laparotomy or laparoscopy. At     present no validated diagnostic tool mapping adhesions exists.      Purpose:      To define the sensitivity and specificity of functional cineMRI in detecting and mapping     adhesions in patients undergoing reoperation.      Design:      Prospective multicenter observational trial      Primary outcome:      Sensitivity and specificity of functional MRI detecting adhesions to the abdominal wall      Secondary outcome:      Sensitivity and specificity of functional MRI detecting organ-to-organ adhesions.      Estimated enrollment: 100 Start study: april 2009      Estimated study completion date: dec 2010      Estimated primary completion date: jun 2010   "
231903|NCT00882180|"     The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and     pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced     solid tumors with liver involvement.   "
231904|NCT00882193|"     This is a non-randomized, open-label study examining the safety and efficacy of betaine in     addition to standard anti-viral therapy in genotype 1 hepatitis C non-responders or relapsers     to previous pegylated interferon plus ribavirin. Betaine (20 gm/day) in 2 divided doses will     be added to Peginterferon alpha 2a (180 mcg) plus weight-based Ribavirin (1000 or 1200     mg/day, for body weight < or > 75 kg, respectively, for 48 weeks. Patients must be diagnosed     with chronic hepatitis C, genotype I, and have undergone therapy for hepatitis C with     pegylated interferon plus ribavirin. Subjects will be followed for safety, tolerability,     hepatitis C viral response and the effect on interferon gene signaling in peripheral blood     mononuclear cells during therapy.   "
231905|NCT00882206|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Decitabine and     vorinostat may alter the cancer cells by reversing the cancer pathways needed for cell     growth. Giving more than one drug (combination chemotherapy) together with decitabine and     vorinostat may kill more cancer cells than with chemotherapy alone.      PURPOSE: This phase II trial is studying how well giving decitabine and vorinostat together     with combination chemotherapy works in treating patients with acute lymphoblastic leukemia or     lymphoblastic lymphoma that has relapsed or not responded to treatment.   "
231906|NCT00882219|"     Interventional, prospective, non-randomized, non-comparative, open and multicentric study of     patients with everolimus-eluting stent  Xience V®  implanted in the treatment of restenosis     in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up     period.   "
231907|NCT00882232|"     The primary purpose of this study is to determine if cross-linked hyaluronan gel reduces the     dose of radiation delivered to the rectum and the rectal toxicity of radiotherapy for     localized prostate cancer.   "
231908|NCT00882245|"     Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children     and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large     parts of the body. The exact cause is unknown but is thought to be an interplay between     genetic and and environmental factors. The objective of this study is to determine whether     SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.   "
231909|NCT00882258|"     Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days.     Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly     for the three month treatment phase.   "
231910|NCT00882271|"     The acupuncture treatment in this study is particularly aimed at reducing the pain and other     negative health events such as emotional trauma and disability associated with Fibromyalgia,     while improving the quality of life and promoting general health.   "
231911|NCT00882284|"     This observational study collects information on the current incidence and management of     hypotension in babies born at term or late preterm that are admitted to Neonatal Intensive     Care Units (NICUs) within the Neonatal Research Network (NRN). Participants include all     newborn infants born at 34 0/7 weeks gestation or greater who are admitted to NICU Network     centers and intubated and mechanically ventilated at less than 72 hours of age. The     information gathered will provide a framework for the design of a potential randomized     controlled trial for the treatment of hypotension in neonates. This observational study is     for a time-limited enrollment period of 4-6 months; NRN centers will continue to enroll until     at least 50 patients are enrolled per center (for approximately 800-1,000 subjects total).   "
231913|NCT00882310|"     The main purpose of this study will be to evaluate the toxicities as well as the efficacy of     a chemotherapy regimen involving the combination of Gemzar, Taxotere, and Xeloda (GTX) in     patients with pancreatic cancer, who have undergone complete surgical resection of their     tumor. During the screening evaluation, subjects will have a physical exam and medical     history taken by either the PI or a Co investigator. In addition, routine blood tests and     radiological exams will be performed, to determine eligibility. Following enrollment,     patients will receive 8 cycles (1 cycle = 21 days) of GTX treatment over 6 months. During     each cycle patients will receive Gemzar and Taxotere on days 4 and 11, through an IV, over     the course of approximately 2 hours, and Xeloda will be taken orally for the first 14 days of     every cycle. Patients will receive no treatment on days 15 thru 21 of each cycle. During each     cycle of treatment patients will have a physical examination, as well as routine blood work.     The first scan will be done prior to initiation of treatment, and the next will be done at     completion of chemotherapy. A short quality of life questionnaire will also be administered     prior to cycle 1 treatment, at the 3-month point, and at the completion of chemotherapy.   "
231929|NCT00882531|"     A national, multicentre, prospective, randomised, double-blind, phase III study in 2 parallel     groups of isotretinoin versus placebo in patients presenting papular-pustular rosacea     resistant to standard therapy. A non-balanced group (2 isotretinoin /1 placebo) design was     selected since, given the nature of the study disease, fewer patients will receive the     placebo than active isotretinoin.      Treatment duration for each patient : 4 months, with monthly evaluation Follow-up at 2 months     and 4 months for patients responsive after 4 months of treatment.   "
231914|NCT00882323|"     Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia as a part of the     conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found     to be more effective in preventing graft versus host disease (GVHD) and rejection of organ     transplants. As the fludarabine based conditioning regimens without total body irradiation     have been reported to be promising for transplantation from alternative donors in SAA,     thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce GVHD and     to allow good engraftment in unrelated donor transplantation. Our previous phase II study of     fludarabine, cyclophosphamide plus thymoglobulin conditioning resulted in good engraftment     (100%) and survival rate (74%). But grade III/IV toxicities occurred in 25% of patients and     all events were treatment related mortalities. As cyclophosphamide is more toxic agent than     fludarabine, we plan a new phase II study re; 'reduced toxicity fludarabine, cyclophosphamide     plus thymoglobulin conditioning regimen for unrelated donor transplantation in severe     aplastic anemia' by reducing dosage of cyclophosphamide and increasing dosage of fludarabine.   "
231915|NCT00882336|"     The main objective of this study is to describe the management of patients with     cardiovascular risk factors in primary prevention among different European countries.      The patient's participation consists of a single study visit during a routine visit of the     patient to the clinic/office.      Study variables will be measured:        -  By an interview between physician and patient during the visit and/or available medical          records' information: social and demographic patient characteristics, relevant family          medical history, current medication.        -  By questions asked to the physician: physician perception of patients' CV risk factor,          guidelines adherence and cost-containment.        -  By measurement performed to the patient during the visit: weight, height, BMI, waist and          hip circumference will be measured.        -  CV risk factors (blood parameters) will be measured by collecting available data          documented within the last year in the medical records and by the collection and          analyses of a blood sample during the visit.   "
231916|NCT00882362|"     To examine the safety and efficacy of long term administration of aripiprazole as an     adjunctive therapy, co-administered with either a selective serotonin reuptake inhibitor     (SSRI) or a selective-norepinephrine reuptake inhibitor (SNRI), in subjects with major     depressive disorder.   "
231917|NCT00882375|"     A comparison of a novel nicotine replacement therapy and placebo treatment in smokers     motivated to quit smoking.   "
231918|NCT00882388|"     Background:        -  The prevalence of arthritis which needs celecoxib prescription is high in patients with          coronary artery disease.        -  The main concern is that celecoxib would increase thrombogenicity by inhibiting the          synthesis of prostacyclin in endothelial cells.        -  It is not known whether the administration of celecoxib would deteriorate antiplatelet          effects of aspirin and clopidogrel which are used after stenting.      Methods:        -  Healthy volunteers (n=40)        -  Randomization into five subgroups        -  aspirin, celecoxib, aspirin+celecoxib, aspirin+clopidogrel,          aspirin+clopidogrel+celecoxib        -  Medication schedule : medication of each drug for 6 days, blood samples at day 0 and day          7        -  Celecoxib 200mg twice a day, and/or aspirin 100mg daily, and/or clopidogrel 75 mg daily        -  Platelet function test : light transmittance aggregometry and arachidonic acid          metabolite assay among subgroups.      Study hypothesis : The addition of celecoxib does not deteriorate antiplatelet function of     aspirin and clopidogrel.   "
231919|NCT00882401|"     Overall research aims: This study will examine the effect of vitamin D supplementation on the     function of the endothelium and microcirculation of patients with chronic kidney disease and     vitamin D deficiency.      Hypothesis: Vitamin D therapy in patients with CKD and concomitant vitamin D deficiency will     improve endothelial, and therefore microcirculatory function, reduce levels of oxidative     stress and thus reduce the risk of future CVS events in this population.   "
231920|NCT00882414|"     The aim of this study is to show the benefits for patients, with a high platelet count, iron     deficiency and IBD, receiving intravenous iron therapy.   "
231921|NCT00882427|"     Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated     that tight blood glucose control in medical and surgical ICU patients results in a     significant better outcome for the patients. Based on this emerging clinical evidence, there     are increasing efforts worldwide to maintain strict glycaemic control in critically ill     patients. However, achieving this goal requires extensive nursing efforts, including frequent     bedside glucose monitoring and the implementation of complex intensive insulin infusion     protocols. A fully automated algorithm may help to overcome some of these limitations by     excluding intuitive interventions and integrating relevant clinical data in the     decision-making process. This study will investigate the performance of an eMPC algorithm     adjusted to target the range 4.4 - 8.3 mmol/L in line with the Surviving Sepsis guidelines.   "
231922|NCT00882440|"     The purpose of this study was to compare the antihypertensive efficacy of different doses of     losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure     of 100-115 mmHg.   "
231924|NCT00882466|"     The purpose of this study is to investigate the effect of intravenous human recombinant     erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in     patients with acute myocardial infarction.   "
231925|NCT00882479|"     The purpose of this study is to learn the daily activities of nutrition management software     users through an improved informed consent process and develop a conceptual model to describe     these activities. The investigators will gather information from nutrition management     software users, and design and test a new prototype of nutrition management software.   "
231926|NCT00882492|"     This is a medical research study designed to see if an infusion of a naturally occurring     hormone, GLP-1, works when used to decrease blood sugar during cardiac surgery.   "
231927|NCT00882505|"     The objective of this study is to assess whether vitamin D supplements are sufficient to     increase females who are deficient or borderline deficient in vitamin D levels to normal     levels.   "
231928|NCT00882518|"     The primary objective of this study is to evaluate the efficacy of quetiapine fumarate     extended-release (XR) used as mono-therapy, administered once daily, in the treatment of     schizophrenic patient with acute episode.   "
232530|NCT00896974|"     This research study is looking at 9cUAB30 in healthy participants. Studying samples of blood     and urine from healthy participants may help doctors learn more about how 9cUAB30 is used by     the body.   "
231930|NCT00882544|"     Performance and outcomes measure are, at this time, relatively unknown for robotic     pyeloplasty procedures. The purpose of this study is to provide a clearer understanding of     the urology department's robotic pyeloplasty quality and outcomes measures. This will be     accomplished by prospectively collecting data for these procedures would ensure that measures     are consistently collected in accordance with a defined protocol, allowing for more valuable     quality and clinical research analysis.      Hypothesis will be defined before data analysis is performed. Amendments specifying future     hypothesis will be submitted the IRB at the appropriate time.   "
231931|NCT00882557|"     The purpose of this study is to determine whether daptomycin at a higher dose given during     the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after     a dialysis session.   "
231932|NCT00882570|"     To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250mg/5 ml fasting     conditions.   "
231933|NCT00882583|"     Primary Objective for Phase I        1. To determine the maximally tolerated dose (MTD) of daily Oral dasatinib in combination          with cetuximab/RT in Cohort A, in patients with AJCC stage II (T2N0) and III (T1-2N1)          SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx.        2. To determine the MTD of daily oral dasatinib in combination with cisplatin/cetuximab/RT          in Cohort B, in patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0)          squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, and larynx.           Primary Objectives of Phase II        3. To estimate the objective tumor response rate and toxicity in Patients treated in          expanded Cohort A and B.   "
231934|NCT00888082|"     Primary objective of this study is to determine the effectiveness of goserelin acetate     (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant     chemotherapy for primary invasive breast cancer by documenting persistence or resumption of     regular menses via menstrual history, serum FSH and E2 measurements.      The secondary objectives of this study are as follows: To investigate the impact of treatment     with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of     ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and     to compare safety and tolerability of study drugs in two treatment groups by evaluation of     adverse events.   "
231935|NCT00888095|"     The aim of this study is to analyze the effects of two different targets of deep brain     stimulation: caudal Zona incerta and Nucleus subthalamicus. The present study will     investigate the effects of DBS using a blind, randomized and stratified design in patients     with Parkinson's disease.   "
231936|NCT00888108|"     This is a Phase 1 open-label study evaluating the safety of ABT-263 when combined with a     standard and weekly regimen of docetaxel in subjects who have solid tumors with measurable     disease.   "
231937|NCT00888134|"     The purpose of this research study is to determine if selumetinib is safe and effective in     treating patients with cancers with a mutated BRAF gene. Selumetinib is an investigational     drug that works by blocking a protein called MEK, which is known to play a role in the growth     of cancer cells lines and tumors that have a mutated BRAF gene. There are multiple types of     cancers that have mutations in the BRAF gene and depend on the activity of this gene for     their growth and survival.   "
231938|NCT00888147|"     During radiation treatment for head and neck cancer a large percentage of patients at Mayo     Clinic Rochester develop the need for tube feeding to meet nutrition and hydration needs.     These patients are usually taking pain medication along with a stool softener or laxative.     Currently, when these patients get a feeding tube it is our standard practice to choose a     fiber-free enteral tube feeding formula as to not worsen their constipation. Currently, there     are no guidelines as to which patients are good candidates for fiber containing enteral tube     feeding formulas. The investigators hope this study will help determine if fiber containing     enteral tube feeding formulas can be used for patients undergoing radiation for head and neck     cancer without increasing rates of constipation or increasing use of stool     softeners/laxatives.      Hypothesis: Participants enrolled in the study will not have increased rates of constipation     on fiber-containing enteral tube feeding formula compared to historical standards on     fiber-free formula.   "
231972|NCT00888719|"     Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate     optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks     to type 2 diabetes patients who are insufficiently controlled by diet and exercise in     comparison to placebo.   "
231973|NCT00888732|"     The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin     analogues will improve post prandial glycaemic control in patients with type 1 diabetes   "
231974|NCT00888745|"     This is a Phase I multicenter study that will be conducted in the United States and Europe.   "
234362|NCT00925106|"     The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected     to provide more favorable bioavailability characteristics than the present commercial     formulation.   "
231939|NCT00888160|"     Early fixation of unstable fractures of the femur, pelvis, and acetabulum reduces some     complication rates. However, in patients with multiple injuries, the optimal treatment of     skeletal trauma may be affected by severe injury to the head, chest, or abdomen. The     relationship between associated injury severity and the timing of definitive management of     unstable fractures is not well-understood. The practice of early total care, early     definitive fracture management, has been criticized by some, who have suggested that     additional hemorrhage with surgery may be associated with a deleterious systemic inflammatory     response. The alternative extreme of damage control orthopedics (DCO) has been recently     proposed as a means of providing provisional stability of major skeletal injury, generally     through external fixation. It is speculated that DCO will diminish the potential for systemic     compromise. However, the need for further (definitive) surgery on a delayed basis, and the     potential additional complications and costs associated with this strategy are controversial.     The investigators' goals are to define which injuries or parameters warrant delay of     definitive orthopaedic care, and to determine what time interval for fracture fixation     promotes optimal patient outcome. The investigators will assess the effects of fracture     fixation on head injury, chest injury, abdominal injury, mortality, complications, patient     outcomes, and costs.   "
234018|NCT00910741|"     The purpose of this study is to determine the recommended dose of NC-6004 according to the     dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy,     safety and tolerability.   "
231942|NCT00888199|"     The purpose of this clinical trial is to determine if the experimental Tensegrity prosthetic     foot offers a reduction of the amount of oxygen used while walking, if stability is improved     over current prosthetic feet, and whether the experimental device actually increases activity     in amputees.   "
231943|NCT00888212|"     The purpose of this study is to evaluate the yield of endoscopic guided fine needle     aspirations (by means of transoesophageal endoscopic ultrasound : EUS-FNA or transbronchial     endoscopic ultrasound : EBUS-TBNA) in patients with a clinical suspicion for sarcoidosis     stage I-II; but in whom the preceding bronchoscopy did not result in a qualifying diagnosis.   "
231944|NCT00888225|"     Epi-X is a multicentered randomized controlled clinical trial of chronic lateral     epicondylitis with parallel group design and two phases. In the first phase physical exercise     treatment is given in the intervention group and expectance in the reference group. In phase     2 eccentric exercise versus concentric is tested.   "
231945|NCT00888238|"     This study will evaluate the effect of a single dose of sitagliptin on glucose dependent     insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG)     procedure.   "
231946|NCT00888251|"     This retrospective chart review and data abstraction will evaluate and quantify the     effectiveness of a comprehensive weight management program. The hypothesis is that the     program will positively affect weight, weight-related comorbidities and medication use.   "
231947|NCT00888264|"     The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II     Disorder, in the course of a major depressive episode. Both the parameters of use of AAPs and     clinical evaluation will be recorded and potential differences that may exist due to     epidemiological factors or comorbidities will be analyzed.   "
231948|NCT00888277|"     This study is designed to identify a brief screening evaluation for MS patients that is     sensitive and specific to the MS population and which correlates with the findings of our     standard-of-care neuropsychological assessments.   "
231949|NCT00888290|"     This study will enroll 25 patients with kidney disease to evaluate the effects of different     doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney     function and muscle strength. The investigators will also evaluate safety and tolerability of     different doses.   "
231950|NCT00888303|"     The purpose of this study is to evaluate the efficacy of 8 mg of dexamethasone administered     prior surgery, to reduce pain, postoperative nausea and vomiting and to improve vocal     function after thyroidectomy for benign disease.   "
231951|NCT00888316|"     RATIONALE: Learning about the effect of excess iron in the liver of patients undergoing donor     stem cell transplant may help doctors plan treatment.      PURPOSE: This study is investigating the effects of iron overload in patients undergoing     donor stem cell transplant.   "
231952|NCT00888329|"     The purpose of the study is to determine whether 40 mg aprepitant administered before surgery     is effective for preventing vomiting in the first 24 hours after surgery in women undergoing     elective hysterectomy.   "
231953|NCT00888342|"     Respiration failure type 2 is loss of the lungs ability to take up oxygen (O2) and get rid of     carbon dioxide (CO2). The diagnosis is based on blood gas measurement of pressures of O2 and     CO2. Patients with COPD is often seen to have co-morbidity with cardiac diseases. Chronic     systemic inflammation is seen in both COPD and cardiac diseases. The investigators will     investigate the sleep quality, CO2-retention, O2-saturation, cardiac arrythmias and markers     of inflammation in 120 patients with COPD in different stages of the disease. Our hypotheses     are:        -  that the first signs of respiration failure type 2 is seen during sleep with alteration          of sleep patterns and greater and more long-lasting retention of CO2 in the blood          compared to those with a normal lung function        -  that the use of alcohol, zopiclone or supplementary oxygen will make these differences          even greater        -  that cardiac arrythmias correlates with hypoxemia        -  that cardiac arrythmias and respiration failure correlates with degree of inflammation   "
231954|NCT00888355|"     The study had a 4 week single blind placebo period followed by 12 weeks of double blind     treatment. Patients were randomized to one of four treatment arms to evaluate the     antihypertensive efficacy of Losartan.   "
231990|NCT00888953|"     The aim of the study is to establish the impact of a falls screening questionnaire in the     adoption of preventive interventions and eventually in the reduction of falls and its     consequences in elder people living in nursing homes.   "
231955|NCT00888368|"     The purpose of this study is:        -  To determine the accuracy of intraarticular placement with the transpatellar tendon          approach as compared to the suprapatellar approach. Patients undergoing knee arthroscopy          will be consented for study of the injection of the fluid into the joint prior to portal          placement or commencement of knee replacement. Patients will be randomized to receive          injections via the transpatellar tendon or superolateral approach. Using injectable          contrast and fluoroscopy, the placement of injections into the knee will be evaluated          for accuracy. Injection attempts with contrast fluid that uniformly coats the articular          surface on sagittal and coronal radiographs will be counted as successful. A          concentration of contrast fluid in extraarticular fat will be counted as a failure.      Hypothesis: The rate of accuracy of intraarticular placement of the needle tip via the     transpatellar tendon approach to knee aspiration is greater than that of the superolateral     approach.        -  To determine the distribution of contrast material with the transpatellar tendon and          superolateral apporaches. Using a previously described evaluation technique of dividing          the knee into seven compartments, sagittal and coronal fluoroscopy images will be          evaluated to determine the distribution of contrast fluid.      Hypothesis: Contrast injected into the knee via the trasnpatellar tendon approach will     penetrate as many compartments of the knee as contrast injected via the superolateral     approach.   "
231956|NCT00888381|"     The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation     of the Enzira vaccine.   "
231993|NCT00888992|"     The purpose of this study is to see if automated telephone monitoring will enhance existing     quitline services, such as Alere Wellbeing's Quit For Life program, and help people quit     smoking. If successful, this intervention could be incorporated into existing quitline     protocols and delivered to millions of people who are trying to quit smoking.   "
231957|NCT00888394|"     MAIN OBJECTIVE: To value the effectiveness of the different quiropody interventions in the     heel pain.      SECONDARY OBJECTIVES: To evaluate the effectiveness of lasw different technologies in front     of each one of the other experimental technologies. To analyze the state of general health     and of quality of the patients' life in all the treatment groups. To analyze the study     cost-effectiveness of each one of the experimental interventions. DESIGN: randomized     controled trial, prospective.      SUBJECT OF STUDY: Patient that go to the Assistance Educational Unit of Podología of the E.U.     Sciences of the Health with footpain like consultation reason.      INTERVENTION: Establishment of four experimental groups with intervention varied podológica.     He/she will be carried out a complete pursuit with valuations at the 1,2, 6, 12 and 24     months, by means of pain scales and function of the foot (FHSQ), the index postural of the     foot (FPI), the study of pressures by means of biofoot/IBV and of the state of general health     (SF-12) and quality of life (Euroqol).      VARIABLES: Of intervention; treatment basic orthopodiatry, treatment advanced orthopodiatry,     of treatment quiropody. Of result: pain and function of the foot (FHSQ), of the state of     general health (SF12) and quality of life (Euroqol). Variables of characterization of the     sample.      ANALYSIS DATA: Descriptive statistic, with measures of central tendency and dispersion of the     study variables. They will be carried out statistical inferenciales between the main     variables of intervention and result (square chi, t Student, ANOVA, Mann-Whitney, Wilcoxon,     according to types and normality of variables). Likewise, measures of the size of the effect     will settle down in the main variables of result, by means of the relative reduction of the     risk, absolute risk and odds ratio, with their respective intervals of trust.   "
231958|NCT00888407|"     The purpose of this study is to design an intervention to increase hepatitis B (HBV)     screening among Hmong Americans.   "
231959|NCT00888420|"     This study is undertaken to assess and improve the existing patient flow, or so-called     throughput process, in an adult outpatient pain treatment clinic.   "
231960|NCT00888563|"     Background:        -  People with many different diseases have symptoms of fatigue, which is a general sense          of tiredness; however, the causes are not fully understood. Fatigue symptoms may be          related to a person s level of fitness, health, and blood chemistries.        -  Researchers are studying the potential role of plasma cytokines (signaling molecules)          and hypothalamic-pituitary-adrenal (HPA) axis (part of the neuroendocrine system that          controls stress) functioning in symptoms of fatigue.      Objectives:        -  To characterize the symptoms of fatigue in healthy individuals.        -  To collect information on fatigue, pain, depression, stress, sleepiness, and quality of          life from healthy adults of all ages.        -  To compare results obtained from people with various illnesses to better understand          possible causes of fatigue that are associated with those diseases.      Eligibility:        -  Physically and mentally healthy volunteers18 years of age or older who can speak and          read the English language.        -  Exclusion criteria include individuals with a disease or condition causing significant          fatigue (congestive heart failure, cancer, or sleep disorders), individuals taking          medicines that cause fatigue (beta blockers, diuretics, or narcotics), and individuals          who have a major psychiatric condition (major depression, anxiety disorder, or          schizophrenia).        -  The following individuals may not participate: those who have two more alcoholic drinks          per day, who use illicit drugs, or who drink more than 4 cups of coffee, 8 cups of soda          or tea, or similar amounts of other caffeine-containing beverages a day, or eat more          than 1 pound of chocolate per day; and individuals who worked evenings or night shifts          in the past month.        -  Women who are pregnant or breastfeeding are not eligible.      Design:        -  Participants must make two outpatient visits to the Clinical Center. Each visit will          last 5 hours and participants must refrain from smoking and consuming alcohol and          caffeine for at least 24 hours.        -  During the first study visit, researchers will conduct the following tests:             -  Psychiatric interview, medical history, pregnancy test, and drug test.             -  Urine test to measure the levels of stress hormones.             -  Questionnaires that measure fatigue, pain, depression, stress, daytime sleepiness,               and activity.             -  Physical fitness test, including strength tests, walking tests, and physical               activity monitoring.        -  Before the second study visit, patients must refrain from smoking and consuming caffeine          and alcohol for at least 24 hours and have nothing, even water, by mouth after midnight.          During the second study visit, the following tests will be conducted:             -  Stress hormone test (participant will receive a cortisol-releasing hormone).             -  Four intravenous blood draws to determine cytokine profiles, gene expression, and               levels of stress hormones (immune and gentic analysis).        -  Participants will receive a small financial compensation for participation in the study.   "
231961|NCT00888576|"     The purpose of this study is to develop a registry with safety and efficacy data on the use     of etanercept in clinical practice in Taiwan.   "
231962|NCT00888589|"     The purpose of this study is to compare two types of radioactive drugs to see if they provide     the same or different information about any disease that may be present in the participants     breast.   "
231963|NCT00888602|"     This is an open label, single use, randomized, 4-period cross-over study. In each period,     subjects will receive one of 4 test combinations. Blood will be drawn prior to study product     consumption and following study product consumption for glucose measures.   "
231964|NCT00888615|"     This phase II trial studies how well elesclomol sodium and paclitaxel work in treating     patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer     that has returned after a period of improvement (recurrent) or is persistent. Drugs used in     chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Elesclomol sodium may also help paclitaxel work better by     making tumor cells more sensitive to the drug.   "
231965|NCT00888628|"     The purpose of the study is to learn if islet transplantation is an effective treatment for     Type 1 diabetes in people who have had a kidney transplant.      The primary objectives of the study are:      - To set up islet transplantation in patients who have had a kidney transplant and who are     using an immunosuppressive regimen that works      The Secondary objective of the study is:        -  To find out if successful islet transplantation leads to improved metabolic control and          reduced renal complication from diabetes   "
231966|NCT00888641|"     Renal hypothermia may preserve renal function in patients who require partial nephrectomy. In     preparation for a definitive randomized controlled trial this pilot study will assess     feasibility and variance data to be used for sample size estimation   "
231967|NCT00888654|"     RATIONALE: The use of diindolylmethane, a substance found in cruciferous vegetables, may slow     the growth of tumor cells.      PURPOSE: This phase II trial is studying how well diindolylmethane works in treating patients     with stage I or stage II prostate cancer undergoing radical prostatectomy.   "
231968|NCT00888667|"     The study will be a prospective cohort study of 20 patients recruited from site's     Defibrillator Clinic patient population who are followed at the site.      Hypothesis: Among the available EGM configuration options, one is better than the others for     detection enhancements purposes.   "
231969|NCT00888680|"     The study is being conducted to explore the safety and effectiveness of a new chemical     entity, BGC20-1531, in subjects with a history of migraine. In this study subjects will treat     a total of three migraine attacks with two different doses of BGC20-1531 and placebo, with at     least one week wash out period between doses.   "
231970|NCT00888693|"     Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the     maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with     an atypical antipsychotic.   "
231971|NCT00888706|"     The purpose of the study is to determine whether individualized social activities, physical     resistance training and walking, and a combination of both are effective in improving     nighttime sleep in elders with dementia.   "
232712|NCT00899678|"     The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and     immunogenicity of certolizumab pegol treatment in pediatric subjects, aged 6 to 17, with     moderately to severely active Crohn's disease. The target enrollment is 160 subjects.   "
231975|NCT00888758|"     The primary objective of this study is:        -  comparison of a safety and effectiveness of third generation DES (biolimus A9 and          everolimus) in patients with STEMI treated by primary PCI with OCT guidance. A rate of 9          month MACE (deaths, myocardial infarction, ischemia driven TLR) will be assessed in both          groups.      The secondary outcomes are a comparison of (using OCT):        -  number of uncovered stent struts        -  number of malapposed stents struts        -  in-stent neointimal volume        -  in-segment assessment of vessel wall response to DES   "
231976|NCT00888771|"     Prospective study of accuracy of colonic polyp characterisation in vivo using high resolution     white light endoscopy, narrow band imaging and chromoendoscopy.   "
231977|NCT00888784|"     The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of     beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal     (GOV2 or IGV1) rebleeding and improvement in survival.   "
231994|NCT00889005|"     This is a randomized controlled study comparing telephone-based cognitive behavioral therapy     (CBT) for recent survivors of traumatic events with Acute Stress Disorder (ASD) or acute PTSD     with a waitlist control group. Survivors with PTSD from both groups will receive face-to-face     CBT one month from the traumatic event. The study's main hypothesis is that early     telephone-based CBT will reduce the prevalence of PTSD three and eight months after the     traumatic event.   "
231978|NCT00888797|"     Colon and rectal cancer is the second most prevalent malignant disease in the western world,     causing significant morbidity, mortality, and healthcare sources use. Treating colon and     rectal cancer with curative intent generally includes resection of the primary tumor. Despite     its crucial role, surgery by itself induce physiological changes resulting in significant     immune depression and other physiological perturbations, which may in turn play a significant     role in the initiation of new metastases and the progression of pre-existing dormant     metastases. The aim of this study is to assess the use of perioperative medical intervention     using a combination of a β-adrenergic blocker (Propranolol) and a COX2 inhibitor (Etodolac),     in order to attenuate the surgically induced immunosuppression and other physiological     perturbations, aiming to reduce the rate of tumor recurrence and distant metastatic disease.   "
231979|NCT00888810|"     The objective of the trial was to evaluate the efficacy of the association of topotecan and     lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.   "
231980|NCT00888823|"     A new type of treatment called stereotactic radiotherapy has recently been developed in hopes     of improving the success of the treatment and improving the convenience to patients, while     reducing the side effects. This study is developing stereotactic radiotherapy as a     state-of-the-art treatment for lung cancer patients.   "
231981|NCT00888836|"     It is generally held that ß-cell function is irreversibly lost already at the time the     disease manifests itself and thereafter continues to decline linearly with time. Several     studies, however, have documented the possibility that ß-cell function may be restored, at     least partially, in type 2 diabetes. Of major relevance to the issue of ß-cell recovery in     diabetes are the following findings:        -  bariatric surgery in morbidly obese patients with type 2 diabetes can restore          euglycaemia, the acute insulin response to glucose and insulin sensitivity;        -  recent studies have reported that diabetic subjects return to euglycaemia and normal          insulin levels within days after surgery, long before a significant weight loss has          occurred; and        -  whereas gastric bypass (GBP) improves insulin sensitivity in proportion to weight loss,          bilio-pancreatic diversion (BPD) improves insulin action out of proportion to weight          loss, i.e., it normalizes it at a time when patients are still markedly obese. Because          RYGB is a predominantly restrictive procedure involving the foregut, whereas BPD is a          predominantly malabsorptive procedure involving the distal gastro-intestinal (GI) tract,          these findings suggest that the control of both insulin action and ß-cell function is          influenced by signals originating from the GI tract.      The principal aim of this study is to verify the effect on type 2 diabetes mellitus (T2DM) of     GBP and BPD, the two operations which have shown specific actions on glucose homeostasis     control, in type 2 diabetic patients with BMI > 35 kg/m2, and to compare this effect with     matched T2DM control patients receiving the standard of medical care.   "
231982|NCT00888849|"     This study is being conducted to compare surgical and patient outcomes across stapled (Group     II) versus hand-sutured (Group I) groups.   "
231983|NCT00888862|"     The main objective of this study is to characterize a range of brain activation symptoms     associated with depression and response to treatment in midlife men and women with MDD, using     MRI and functional MRI. Moreover, in the female sub-group, the investigators will examine     whether these brain activation symptoms are related to menopausal symptoms (i.e., hot flashes     and night sweats). Also, assessing brain activation before and after the treatment might help     to uncover some mechanisms associated with the pathophysiology of depression and menopause.   "
231984|NCT00888875|"     We evaluate feasibility of fiberoptic intubation through the ILMA Fastrach vs the i-gel.     Both are airway devices to be introduced in the mouth we the possibility to ventilate the     patient and furthermore to be a guide to introduce a tracheal tube. We first insert either     the ILMA or the i-gel. In a second step, we will introduce a tube through the device, all     guided visually through a fiberoptic tool which works as a railroad for the tracheal tube.   "
231985|NCT00888888|"     Although many reports have been published on colonic resections in patients with suspected     appendicitis and the diseases that cause the decision to resect the colon have been     identified and their proper treatments have been established, there is no report on the risk     factors present in converting a simple appendectomy into a major colonic resection.      The investigators aimed to identify the risk factors that lead the surgeon to perform a     colonic resection in patients undergoing surgery for initially suspected acute appendicitis.   "
231986|NCT00888901|"     This is a single-center, prospective, controlled study with one eltrombopag treatment group     and 2 control groups, one on standard steroid treatment, and another one untreated.      The aim of the study is to determine the effect of Thrombopoietin Receptor (MPL) agonists on     shear-induced platelet activation.   "
231987|NCT00888914|"     The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate     to severe lateral canthal lines in adults.   "
231988|NCT00888927|"     This study will determine the maximum dose of KW-0761 administered intravenously that can be     given safely in subjects with previously treated peripheral T-cell lymphoma (PTCL) or     cutaneous T-cell lymphoma(CTCL)and will see if it is effective in treating the disease.   "
231989|NCT00888940|"     A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to     Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding   "
231991|NCT00888966|"     Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to     31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA     is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on     survival. But the mechanisms underlying these therapy are not clear.      Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well     demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a     clinical setting.      The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest     treated with mild hypothermia.   "
231992|NCT00888979|"     We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine     exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.   "
231995|NCT00889018|"     The purpose of this study is to determine whether an increase in the dose of carboplatin in     treatment of advanced intraocular (group C and D) retinoblastoma helps in avoiding     radiotherapy and improves the rate of globe salvage.   "
232000|NCT00889083|"     Multi-organ failure due to sepsis is a major cause of death in critically ill patients. But     the mechanisms leading to this condition are not fully understood. Mitochondrial dysfunction     has been shown in skeletal muscle of critically ill septic patients. Liver is very important     in sepsis as it is responsible of the synthesis of several inflammatory proteins. Moreover     hepatic failure is associated to a bad outcome.      The aim of this study is to evaluate the hepatic mitochondrial function in sepsis.   "
232001|NCT00889096|"     1. To evaluate the effects of a single oral (80 mg) dose of propranolol on the encoding of          emotional pictures as assessed by peripheral physiological and electrocortical          parameters in a healthy population.        2. To evaluate the effects of a single oral (80 mg) dose of propranolol on the retrieval of          emotional pictures as assessed by electrocortical parameters in a healthy population.        3. To evaluate correlations between behavioral data and psychophysiological parameters.   "
232002|NCT00889109|"     Shoulder dislocations are common and may result in functionally disabling instability.     Disruption of the shoulder capsuloligamentous complex during shoulder dislocation is related     to poor proprioceptive and stabilizing capabilities of the joint. It has been demonstrated     that surgical restoration of the normal glenohumeral capsular tensioning improves the     proprioceptive capability of the shoulder and plays an important roll in restoring shoulder     stability.      Several studies compared the proprioceptive capabilities of the shoulder between different     surgical procedures, however only few have used the dynamic unrestricted 3-dimensional arm     movement model that has been shown to be more appropriate for assessment of glenohumeral     proprioception. To our knowledge, no previous study has compared proprioception measures of     the glenohumeral joint following arthroscopic versus open repair for anterior shoulder     instability, using the 3-dimensional unrestricted arm movement model.   "
232003|NCT00889122|"     The purpose of this study is to determine if an interactive game (Dance Dance Revolution/DDR)     can promote healthy physical activity for the health of all family members   "
232004|NCT00889135|"     This study is designed to supply L-DOPS (droxidopa) on a long term basis to patients with a     genetic form of profound orthostatic hypotension, most commonly DBH deficiency. It also     allows us to collect medical history information on this small population of patients that     would allow us to determine if there are any complications from this type of treatment.   "
232005|NCT00889148|"     Total hip arthroplasty is amongst the most painful procedures postoperatively, and pain     management can be a challenge. Different measures have been introduced to manage severe     postoperative pain in these patients. Previous studies have investigated gabapentin in acute     postoperative pain and demonstrated reduced postoperative pain, postoperative morphine     consumption, morphine related side effects, and postoperative pain scores. To date, this     analgesia adjunct has yet to be investigated for total joint arthroplasty patients.   "
232006|NCT00889161|"     This is a single center, open label forced dose titration study designed to determine the     tolerability of curcumin in pediatric patients with inflammatory bowel disease (IBD). This     study will provide initial tolerability and safety data in pediatric patients with IBD.     Twenty patients with IBD in remission or with mild disease (score <34 on PUCAI or score <30     on the PCDAI) on sulfasalazine or mesalamine aged 8 to 18 years will be enrolled into this     study. Each patient will participate in the study for nine weeks. From this study an     appropriate dosage will be determined to proceed with a double blinded placebo controlled     study.   "
232022|NCT00889369|"     The main objective of this study is to characterize a range of brain activation symptoms     associated with major depression in peri- and post-menopausal women. Also, assessing brain     activation before and after the treatment might help to uncover some mechanisms associated     with the pathophysiology of depression and menopause.   "
232007|NCT00889174|"     Background:      - A leukodystrophy is a disease affecting the white matter of the brain. The white matter     conducts electricity from one part of the brain to the other. If the insulation, or myelin,     is damaged, the brain s electrical pathways will not work properly. Researchers are trying to     identify what causes leukodystrophy.      Objectives:        -  To collect detailed clinical characterizations, including histories, physical          examinations, biochemical tests, genetic studies, and neurophysiologic and neuroimaging          studies in patients with unclassified leukodystrophies to comprehensively characterize          such patients and obtain comparative clinical profiles.        -  To collect detailed clinical characterizations, including histories, physical          examinations, biochemical tests, genomic and proteomic tissue, and neurophysiologic and          neuroimaging studies in patients with known leukodystrophies to investigate the          underlying pathogenesis of these disorders.        -  To better understand leukodystrophies of unknown cause and to identify the part of the          DNA of the patient with leukodystrophy that is causing the problem.      Eligibility:        -  Any individual with a known or suspected leukodystrophy is eligible to participate in          this protocol, including             -  Patients with white matter disease that is unclassified or of unknown cause,               including but not limited to leukoencephalopathies with calcifications,               leukoencephalopathies with cysts, leukoencephalopathies with hypomyelination, and               leukoencephalopathies with brainstem involvement.             -  Parents or siblings of these subjects.        -  Exclusion criteria include patients too ill to travel to the Clinical Center and          patients for whom the leukoencephalopathy is felt to be secondary to an acquired cause          (for example, traumatic or infectious).      Design:        -  Patients will be seen either as an inpatient or outpatient depending on the tests that          are planned. Patients may need to stay at the Clinical Center for 3 to 5 days.        -  The following tests will be conducted as part of standard clinical care:             -  Physical and neurological examinations, including blood and urine tests.             -  Magnetic resonance based studies to produce a picture of the patient s brain (under               general anesthesia).             -  Spinal tap to measure chemicals in the spinal fluid (under general anesthesia in               young children).             -  Nerve biopsy, if the peripheral nerves are affected, or muscle biopsy, if the cells               called the mitochondria or the muscles are involved (both under general               anesthesia).        -  The following studies may be performed as part of participation in the research:             -  Blood, urine, spinal fluid, or muscle to understand the proteins, DNA, and               molecules in these tissues.             -  Skin biopsy to grow (in culture) skin cells and to analyze the skin               microscopically.             -  DNA studies to find new genes responsible for leukodystrophies and to better               understand these diseases.        -  Participation should be based on an interest to help further the research on          leukodystrophies. Specific information about a patient s present or future health risks          may not be gained.   "
232008|NCT00889187|"     The purpose of this research study is to determine if it is possible to deliver high dose     radiation in one week while also giving the drug capecitabine for the treatment of pancreatic     cancer prior to surgery, to determine if this treatment can be given safely for the treatment     of pancreatic cancer prior to surgery and, to determine if this treatment can improve the     local control pancreatic cancer prior to surgery compared to historical controls of standard     treatment.   "
232009|NCT00889200|"     This study was designed to use a sensitive neuroendocrine probe, the     Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults     with insomnia. The primary aim was to assess cortisol reactivity before and after long-term     (6 weeks) administration of eszopiclone. It was hypothesized that treatment with eszopiclone     would result in a significant reduction in plasma cortisol response to the DEX/CRH test     following treatment of insomnia with standard dose of eszopiclone.   "
232169|NCT00891163|"     The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera     topical patch (using sensory depth and pain depth evaluations), and to determine the duration     (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing     and thermal sensory testing evaluations), compared with a matching heated placebo patch.   "
232010|NCT00889213|"     The purpose of this trial is to determine whether the use of an autologous falciform ligament     patch combined with fibrin glue will reduce the rate of pancreatic fistula in patients     completing distal pancreatectomy. The hypothesis for the current trial is: Autologous     falciform patch closure with fibrin glue will result in a 50% decrease in fistula formation     postoperatively. The primary end point will be the development of pancreatic fistula using     the ISGPF definition of pancreatic fistula1. (Drain output of any measurable volume of fluid     on or after postop day #3 with an amylase content greater than three times serum amylase).     Secondary end points will include length of postoperative hospital stay, percutaneous     intervention rates, re-operation rates, morbidity to include delayed gastric emptying, wound     infection, intraabdominal abscess, postoperative hemorrhage and 30-day mortality.(Bassi C,     Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: An international study     group (ISGPF) definition. The Journal of Surgery, 2005;138:8-13).   "
232011|NCT00889226|"     A randomized, open label, dose titration study to evaluate the efficacy and safety of     Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia   "
232012|NCT00889239|"     The objectives of this study are to characterize the clinical performance and wear mechanisms     of all-ceramic posterior crowns. The wear rate of all-ceramic crowns and opposing enamel in     selected patients will be quantified. The relationship of each subject's maximum clenching     force and wear rate will also be analyzed.   "
232013|NCT00889252|"     The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal     volunteers.   "
232014|NCT00889265|"     This is a prospective, multi-center study to evaluate the use of CopiOs Pericardium Membrane,     a bovine xenograft, with use of Puros Cancellous Particulate Allograft, for the augmentation     of localized alveolar ridge defects on either the maxilla or mandible.   "
232015|NCT00889278|"     The purpose of this study is to determine if higher absolute lymphocyte count in the infused     stem cell autograft (A-ALC) will lead to an improved antibody response to post-transplant     immunization with Pneumococcal Conjugate Vaccine and permit effective immunization at 6     months post-transplant in lymphoma patients receiving Autologous Peripheral Blood Stem Cell     Transplantation.   "
232016|NCT00889291|"     Post market observational survey of a vascular access device for access-challenged patients.     Data collection efforts focused on patient medical and access history and implant procedure     results.   "
232017|NCT00889304|"     Evaluation of the Position HTO system in patients with unicompartmental medial arthrosis     after open wedge high tibial osteotomy   "
232018|NCT00889317|"     Speech develops through a co-structuring of auditory and motor representations, especially in     the first years of life during language acquisition. In the present study, we will test by     means of functional magnetic resonance imaging whether vowel perception and production might     depend on a coordination of auditory and motor, articulatory, cortical maps. The outcome of     this study will lead to a better understanding of whether both vowel perception and     production are processed in the human brain and will provide important insight into     brain-language relationships. Besides new theoretical perspectives on speech perception and     production, this project might raise important questions concerning patients with speech     disorders by identifying which aspects of speech perception and production are functionally     linked.   "
232019|NCT00889330|"     The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.   "
232020|NCT00889343|"     The purpose of this study is to determine whether sorafenib in combination with chemotherapy     has a positive effect on time to progression of the tumor or death for the treatment of large     bowel cancer that has already progressed during a first chemotherapy.   "
232021|NCT00889356|"     The purpose of this study is to determine the Efficacy, Tolerability & Safety of Combination     of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days     in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and     Amphotericin B 50mg in Vaginal Cream.   "
232024|NCT00889395|"     The Mediational Interventions for Sensitizing Caregivers (MISC) model developed by Professor     Pnina Klein is to enhance the cognitive and social development of children throughout the     developing world . Although MISC has proven effective in a longitudinal study in two poorer     communities of Addis Ababa, Ethiopia , it has not been used with HIV households or in the     Ugandan context where there is desperate need for enhanced caregiving in HIV-affected     families. We propose to work with community leaders, healthcare workers, and     parents/caregivers in adapting MISC to the Ugandan cultural and social context in Kayunga.     For intervention families, MISC training will be added to an ongoing home health care visit     (HHCV) program already in place for HIV children in Kayunga district. We will then evaluate     whether MISC parent/caregiver training improves cognitive and psychosocial development in     their children, and whether clinical stability of the HIV child is an important modifier for     MISC training benefit.   "
232025|NCT00889408|"     This is a phase I dose escalation study of DT2219ARL for the treatment of relapsed or     refractory B-lineage leukemia and lymphoma. Patients will receive a single course of     DT2219ARL as a 4 hour infusion on days 1, 3, 5, and 8. Weekly follow-up will continue through     day 29, at which time a disease reassessment will be done. For patients in remission,     follow-up will continue monthly until disease progression or start of a new treatment.     Otherwise day 29 will be the final study visit if there is no ongoing toxicity.      This phase I study will use Continual Reassessment Method (CRM) to establish a maximum     tolerated dose (MTD) of DT2219ARL. Up to 3 dose levels will be tested with an additional dose     level (-1) if dose level 1 proves too toxic. The goal of CRM is to identify the dose level     which correspondences to a desired toxicity rate of 33% or less using grade 3 or 4 capillary     leak syndrome and any grade 3 or greater toxicity attributed to DT2219ARL as the targeted     toxicity (based on CTCAE version 4).   "
232026|NCT00889421|"     The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment     of uveitis.   "
232058|NCT00889850|"     The present study will be conducted in order to compare the bioavailability of 40 mg     Esomeprazole Mepha (Mepha Ltd., Switzerland) and of INexium 40 mg MUPS tablets (AstraZeneca,     France) under single dose fasted and fed conditions.      The study will be conducted as a combined single dose study under fasted and fed conditions     in a 2x2-period cross-over design with a wash out phase of at least 6 treatment-free days     between administrations.   "
232027|NCT00889434|"     -  Working Hypothesis: EGCG and Tocotrienol can act as genetic modifiers and increase the          level of correctly spliced CFTR transcripts.        -  Aims of the Study: To determine in patients with CF if oral administration of EGCG and          Tocotrienol, both separate and in combination, modify CFTR splicing towards normal          splicing as evaluated by improved Transepithelial Potential Difference (TEPD) assessment          of chloride secretion.      To assess the effect of EGCG and Tocotrienol, both separate and in combination, on (1)     additional TEPD measures of ion channel activity, (2) levels of correctly spliced CFTR mRNA     in nasal mucosa, (3) cytokine levels in sputum and (4) changes in pulmonary function over the     course of the study.        -  Potential Implications to Medicine: Alternative splicing mechanisms are a common cause          of genetic disease as ~15% of all known human mutations result in defective pre-mRNA          splicing. Therapies based on augmenting the levels of full length or fully functioning          proteins may have a substantial impact on the treatment of patients with genetic          diseases.        -  Contribution of the expected outcome to society Today genetic diseases can be treated          but not healed. This proposal may be a step in the direction of finding a cure for          patients carrying splicing mutations.   "
232028|NCT00889447|"     This research is being done to study mechanisms of progression of COPD and to develop     treatments for it. The investigators are doing the present study to identify people age 40     and older with mild to moderate COPD who will qualify for such studies to include in a     database. The study will include establishing a screening evaluation or characterization of     the following two studies:        -  Emphysema Progression in COPD- Losartan's Effects on Airway Parameters - NA_00009980        -  Sleep-Related Physiology and Inflammation in Chronic Obstructive Pulmonary Disease -          NA_00001771   "
232029|NCT00889460|"     The purpose of this study is to determine the safety and tolerability of several doses of r     Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.   "
232030|NCT00889473|"     This study will look at one dose of AT1001 for efficacy and safety for the treatment of     celiac disease.      The primary efficacy outcome is the rate of response to gluten.   "
232031|NCT00889486|"     The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate,     gastroparesis symptoms and health-related quality of life in diabetic patients with     gastroparesis.   "
232032|NCT00889499|"     Chronic pain is associated with hypersensitivity of the central nervous system. The drug     under investigation (tropisetron) has been shown in animal studies to attenuate central     hypersensitivity. It has therefore the potential to be effective in chronic pain. We compare     two doses of tropisetron with placebo in patients with chronic pain. We measure pain     intensity and parameters that assess central hypersensitivity.   "
232033|NCT00889512|"     The purpose of this study is to develop a new protocol using two different types of fertility     drugs that is more similar to the way the hormones act in a normal menstrual cycle (period).      We are recruiting women who are trying to get pregnant through In Vitro Fertilization (IVF)     who either have a high prolactin level (a hormone normally found in your blood that is     produced in the brain) or have a condition known as hypothalamic amenorrhea in which one does     not get regular periods due to low hormone levels.      The ovaries can be stimulated with Follicle Stimulating Hormone (FSH) alone and with FSH and     Luteinizing Hormone (LH). FSH causes eggs to be made while LH causes estrogen (hormone)     production. The women in this study have low hormone levels and need both FSH and LH.     Luveris® (LH hormone) is a new drug approved for egg production and is used in IVF. There is     no set amount of LH nor a set protocol for LH use. Therefore, we are testing this new     regimen. One group of women will receive a fixed dose of LH throughout their cycle while the     other will decrease the dose of FSH while at the same time increasing the LH dose which is     what happens in the natural menstrual cycle.   "
232034|NCT00889525|"     This study was designed to check the efficacy of a new oral medical drug treatment, namely     Cabergoline, for the treatment of Cushing Disease due to pituitary adenoma.      Background: Cabergoline is a Dopamine 2 receptor agonist. Corticotroph adenoma has shown to     have the D2 receptor in in vitro studies.   "
232035|NCT00889538|"     This is a double-blind, placebo-controlled crossover study to evaluate the safety and     efficacy of glutathione alone or glutathione, vitamin C and NAC treatment in children with     autism who also have severe behavior problems. The investigators hypothesis is that children     with autism will show improvement in both learning capabilities and behavior with either     glutathione, or glutathione, vitamin C and NAC therapy.   "
232036|NCT00889551|"     This study intends to observe the epidemiology of pregnancy and growth of adolescent mothers     and their child in their first year on the development and growth ambulatory at Brasilia     University Hospital (HUB).      The study hypothesis is that adolescent growth is disturbed by a pregnancy in this age.     Another hypothesis is that their child's growth and development could be obstructed.   "
232037|NCT00889564|"     The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular     Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is     hypothesized the bacteremia rate associated with the HeRO device will be lower than a     historical literature control of tunneled dialysis catheters.   "
232038|NCT00889577|"     The primary purpose of this study is to evaluate the association between nonalcoholic fatty     liver disease (NAFLD) by computed tomography (CT) scan and coronary artery disease (CAD)     measured by the calcium (CAC) score among HIV-infected persons.   "
232039|NCT00889590|"     This is a multicenter, randomised phase II trial in patients with high risk GCT.      Primary objective:        -  Determine if adjuvant zoledronic acid improves the 2 years recurrence rate of 'high          risk' GCT as compared to standard care      Secondary objectives:        -  Determine the relapse free survival        -  Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT   "
232040|NCT00889603|"     The Aricept® Evess study is a prospective, non-comparative, non-interventional study on use     of Aricept® Evess in the treatment of out-patients with AD and Vascular Dementia. The 24 week     length of the study aims to collect data from a large number of patients (n= 400) on the     safety and efficacy at the usual dosage of the product providing an overview of Aricept®     Evess profile.   "
232041|NCT00889616|"     Background:        -  Globally, the Plasmodium falciparum parasite is responsible for at least 247 million          acute cases of malaria each year, resulting in about 1 million deaths. Approximately 90          percent of these deaths, the majority in children under 5 years of age, occur in Africa          due to infection with P. falciparum.        -  People living in endemic areas develop natural immunity to P. falciparum as a result of          repeated infection. Consequently, children who survive to 5 years of age rarely succumb          to life-threatening disease despite frequent infection. This acquired immunity is          mediated in part by blood-stage parasite-specific antibodies. Thus, parasite proteins          expressed during the blood-stage have been proposed as good candidates for inclusion in          a vaccine.        -  A number of P. falciparum merozoite antigens have been identified as promising          blood-stage vaccine candidates, including Merozoite Surface Protein 1 (MSP 1) and Apical          Membrane Antigen 1 (AMA 1). This Phase I study is the first time that the combination          vaccine (BSAM-2/Alhydrogel +CPG 7909) will be given to humans. The vaccine will be          administered in a randomized, open-label (U.S.)/single-blinded (Mali), dose-escalating          trial.      Objectives:        -  To assess safety and reactogenicity of the combination vaccine (BSAM-2/Alhydrogel +CPG          7909) in malaria-naive U.S. adults and semi-immune Malian adults.        -  To determine the antibody response of the combination vaccine to the AMA 1 and MSP 142          proteins, as measured by antibody levels and parasite growth inhibition.        -  To determine the extent to which the antibody response to the individual antigens (AMA 1          and MSP 142) is correlated when the combination vaccine is given, and to determine T and          B cell responses to vaccination.      Eligibility:        -  United States: Healthy volunteers between 18 and 50 years, inclusive. Available for the          52 weeks of the trial and willing to participate in the study as evidenced by signing          the informed consent document.        -  Mali: Healthy volunteers between 18 and 45 years, inclusive, and a known resident of the          village of Bancoumana. Available for the 52 weeks of the trial; willing to participate          in the study as evidenced by signing the informed consent document or by fingerprinting          the consent document with the signature of a witness.        -  Potential participants must meet extensive health and screening requirements to          participate in this study. Good general health is required as a result of review of          medical history and clinical testing at the time of screening.        -  Women who are pregnant or breastfeeding are not eligible.      Design:        -  During the 52-week study, participants will receive the first vaccine and complete the          following:             -  Physical examination and patient education regarding the signs and symptoms of               potential adverse effects.             -  Blood and urine testing, and vital signs (blood pressure, temperature, heart rate,               and respiratory rate).             -  United States: Education on the use of digital thermometer, injection-site reaction               measurement, and malaria vaccine side-effect memory enhancement tool (daily symptom               diaries).             -  Mali: Additional blood draws for malaria smear and urine test for chloroquine               testing.        -  U.S. and Mali participants will return to the study site on specified days throughout          the 52 weeks to receive two additional vaccines, record vital signs, complete additional          blood and urine testing, and review patient education.        -  U.S. participants will record oral temperature once during the day, as well as pain,          tenderness, redness, swelling at the injection site and any systemic signs or symptoms          for 6 days following each immunization.        -  Participants will receive financial compensation (United States) or food (Mali) to          compensate for their time.   "
232059|NCT00889863|"     This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part     II and the ability to taper steroids in the open label Part I.   "
232042|NCT00889629|"     People with kidney transplants often develop bone disease. One reason for bone disease may be     overactivity of a gland in the neck called the parathyroid gland. Overactivity of the     parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been     discovered that many patients with kidney transplants have low Vitamin D levels. The     investigators are examining the effects of doxercalciferol on parathyroid hormone levels,     proteinuria and bone turnover markers in people who have had a kidney transplant.   "
232043|NCT00889642|"     The purpose of this study is to evaluate the effectiveness of administering Lidocaine and     Epinephrine using an iontophoretic device treatment to provide local anesthesia to healthy     adult volunteer subjects undergoing venipuncture.   "
232044|NCT00889655|"     Prior to colonoscopies, the colon is cleansed using a laxative. Golytely is approved by the     FDA for this purpose. Another laxative, called MiraLax, is approved by the FDA to relieve     constipation, but it is not approved specifically for preparation for a colonoscopy.     Nonetheless, it is commonly used in clinical practice for this purpose, just as is Golytely.     The purpose of this study is to compare Golytely and MiraLax in two ways: to see whether one     is better tolerated by patients than the other and to see whether one more effectively     cleanses the bowel than the other. The investigators' hypothesis is that these 2 bowel     preparation methods are equally effective in bowel cleansing, but that patients prefer     Miralax to Golytely.   "
232045|NCT00889668|"     Diabetes is a leading cause of death in the Western World with medical costs increasing     annually. There is no cure for diabetes, and blood glucose monitoring is a key component in     diabetes treatment and management. Self-monitoring of blood glucose levels is essential to     the self-management of diabetes and has become widespread over the past decade. Blood glucose     determinations are currently done by invasive methods (finger tip pricking), followed by     measuring the blood drop characteristics.      The purpose of this trail is to demonstrate the performance and use of GlucoTrack device in     measuring blood glucose levels.      The rationale for development of the device is to improve the patient's quality of life by     providing a device that is easily used and provides a painless measurement method, thereby     leading to higher compliance, and to better managed diabetes   "
232046|NCT00889681|"     This Continued Access Protocol has been written to allow ongoing treatment of subjects at     selected investigational sites while the marketing application for the Arctic Front®     Cryoablation System is under review. This study will also allow collection of additional     safety data following modifications implemented into the Arctic Front® Catheter and     Cryoablation System.   "
232047|NCT00889694|"     This study is a 12-week, randomized, placebo and positive drug controlled clinical trial to     investigate whether tripterygium capsule is effective and safe in treating patients with     ankylosing spondylitis. The investigators expect that the tripterygium capsule is more     effective than placebo and has few adverse effects.   "
232048|NCT00889707|"     The purpose of this study is to determine whether PRX302 is safe and effective in the     treatment of moderate to severe Benign Prostatic Hyperplasia (BPH).   "
232049|NCT00889720|"     It is possible to offer smoking cessation treatment including varenicline to patients     scheduled for elective surgery. This study will evaluate whether or not this will enable some     patients to quit smoking for up to 4 weeks prior to surgery and in turn, whether this may     lead to reductions in post-operative complication such as wound infections.   "
232050|NCT00889733|"     The purpose of this study is to determine whether intraperitoneal (IP) Cisplatin combined     with intravenous (IV) Paclitaxel is well tolerated in women with epithelial ovarian cancer     who have had neoadjuvant chemotherapy followed by initial debulking surgery.   "
232051|NCT00889759|"     The aim of this study is to evaluate the role of high-resolution computed tomography of the     chest (HRCT) in the investigation of an outbreak of TB that developed in the South Korean     army.   "
232052|NCT00889772|"     The purpose of the study is to externally validate the acute lung injury/acute respiratory     distress syndrome (ALI/ARDS) prediction model (Lung Injury Prediction Score - LIPS) in a     multicenter sample of patients at risk presented to the acute care hospitals: United States     Critical Illness and Injury Trials Group (USCIITG).   "
232069|NCT00889993|"     People who eat more dietary fiber have a lower body weight than people who eat less fiber.     Potential mechanisms include greater feelings of satiety, reductions in food intake, changes     in blood glucose, insulin, or gut hormones.      The investigators hypothesize that increasing doses of mixed fiber will influence satiety     response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent     manner, when given to subjects in muffins for breakfast.   "
232053|NCT00889785|"     The proposed research will test a new comprehensive disease management intervention with     adolescents who have type 2 diabetes using a randomized controlled trial (RCT). Adolescents     subjects with a history of Type 2 Diabetes and a parent caregiver will be consented,     enrolled, and randomly assigned to either an 6-month intervention (N=44) or a usual care     comparison (N=44). Recruitment will take place within the Vanderbilt Eskind Pediatric     Diabetes Clinic. The intervention will include participation in a comprehensive disease     management program that includes: (1) application of treatment algorithms, (2) phone     assessment from a diabetes nurse practitioner and dietician to assess barriers and promote     problem solving, treatment adherence and management, and (3) a behavioral     Internet-administered self-management problem solving component. Outcomes include     self-reported self-management behaviors (exercise, diet, medication adherence, etc.), blood     pressure, weight/BMI, and glycated hemoglobin (A1C).   "
232054|NCT00889798|"     The purpose of this registry is to record information on therapy reality of malignant     lymphatic systemic diseases by office-based haematologists in Germany.   "
232055|NCT00889811|"     In recent several clinical trials, remote preconditioning showed very powerful myocardial     protection. However, the myocardial protective effect by remote preconditioning was not     evaluated on the patients undergoing off pump coronary artery bypass graft surgery (OPCAB).      The investigators hypothesized that the lower limb remote preconditioning could protect the     myocardium during the OPCAB. In this study, the investigators will try to evaluate whether     remote preconditioning could induce myocardial protection on the OPCAB patients.   "
232056|NCT00889824|"     The goal of this project is to provide individuals that have a balance deficit with a device     that will give them signals that they can feel (vibrations) in order to help them maintain a     correct sense of balance and perception of place in the environment.   "
232062|NCT00889902|"     The purpose of this study is to:        1. make p16INK4A as a cervical cancer screening of tumor markers, cytology improve existing          diagnostic sensitivity, specificity, repeatability and validity, so as to effectively          prompted the early discovery and diagnosis of cervical cancer.        2. reduce screening costs, screening and benefits into quantitative evaluation, for our          country to develop cervical cancer prevention and control strategy to provide a reliable          theoretical basis.   "
232063|NCT00889915|"     This study will determine whether two new psychostimulant medications are more effective,     tolerable, and acceptable than two older medications for treating attention deficit     hyperactivity disorder.   "
232064|NCT00889928|"     The study will document being able to successfully remove a subject's gallbladder through the     vagina (laparoscopic visualization)using a small collection of study surgical tools.   "
232065|NCT00889941|"     The purpose of this study is to evaluate whether the size of the pupil has an effect on     quality of vision in patients undergoing LASIK surgery.   "
232066|NCT00889954|"     Patients have advanced stage cancer. This study is a gene transfer research study using     special immune cells.      The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancers. This research study combines two different ways of fighting cancer:     antibodies and T cells. Investigators hope that both will work better together. Antibodies     are proteins that protect the body from diseases caused from infectious diseases and possibly     cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that     can kill other cells, including tumor cells or cells that are infected with germs. Both     antibodies and T cells have been used to treat patients with cancers: they both have shown     promise, but have not been strong enough to cure most patients.      T lymphocytes can kill tumor cells but there are normally not enough of them or they are not     able to kill all the tumor cells. We have done research in which we have grown extra T     lymphocytes. We have added genes to those T lymphocytes to help them to recognize tumor     cells. Although the results have been promising, we are still doing more research in this     area.      Antibodies usually circulate in blood and are secreted by other cells of the immune system in     response to the presence of germs or abnormal cells in the body. The antibody used in this     study is called anti-HER2 (Human Epidermal Growth Factor Receptor 2). This antibody sticks to     HER2-positive cancer cells because of a substance on the outside of these cells called HER2.   "
232067|NCT00889967|"     The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for     Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.   "
232068|NCT00889980|"     There is a significant need to develop new and more effective ways to treat melanoma that     will decrease patient morbidity and mortality. This protocol intends to collect and process a     portion (< 20% of any node) of lymph nodes from melanoma patients undergoing routine surgical     SLN resection: the SLN(s) and 1 adjacent non-SLN(s) are planned for study. In addition, blood     will be drawn at the pre study visit (serum and peripheral blood mononuclear cells) and     appropriate lineage control tissue will be collected. Material only from already-indicated     and planned procedures as part of standard medical care will be used. The main goal of this     study will be to properly collect and process material to be analyzed and explore the     molecular features melanoma biological samples.   "
252996|NCT01167309|"     The purpose of this trial is to determine the safety and tolerability of ascending single and     multiple oral doses of LEO 27847 in secondary hyperparathyroidism patients.   "
232070|NCT00890006|"     The integration of magnetic resonance imaging (MRI) in the treatment planning process for     prostate cancer will reduce uncertainties in delineation of the prostate gland, and will     enable delineation of the urethra, penile bulb, and internal pudendal artery. The integration     of daily cone-beam computed tomography (CBCT) will markedly reduce set-up uncertainties,     thereby reducing the minimum planning target volume (PTV) margin. By combining MRI simulation     and daily CBCT, and by adapting radiation delivery accordingly, the investigators will reduce     dose delivered to the rectum, bladder, urethra, and erectile structures. In this study, the     investigators seek to determine whether this dose reduction translates to improved patient     outcomes. In a prospective, 2-stage design, up to 190 patients will be enrolled. In the first     stage, advanced imaging will be integrated without altering dose planning techniques. Stage 2     will reduce dose delivered to normal tissues, and will collect toxicity outcome measures.     This clinical trial will be conducted over 3 years.   "
232071|NCT00890019|"     This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63     ME-TRAP, simian adenovirus encoding Plasmodium falciparum antigens. This follows promising     phase I clinical studies of MVA ME-TRAP and preclinical studies of AdCh63 and MVA ME-TRAP     used together in prime-boost regimes. All volunteers recruited will be healthy adults. They     will be primed with various doses of AdCh63 ME-TRAP administered intradermally or     intramuscularly. Some of the volunteers will receive a booster vaccination with MVA ME-TRAP     at various doses administered via the intradermal or intramuscular route. Safety data will be     collected for each of the eight regimens. Secondary aims of this study will be to assess the     immune responses generated by each of these regimes.   "
232072|NCT00890032|"     RATIONALE: Vaccines made from a person's tumor cells and dendritic cells may help the body     build an effective immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating     patients undergoing surgery for recurrent glioblastoma multiforme (GBM).   "
232073|NCT00890045|"     Compare the HeRO Vascular Access Device to a conventional ePTFE graft.   "
232074|NCT00890058|"     The CIRAS study will investigate postmenopausal breast cancer patients with hand pain and     compare those receiving aromatase inhibitors (cases) to breast cancer patients with hand pain     not receiving aromatase inhibitors (controls) in order assess whether this syndrome is an     inflammatory arthritis.   "
232075|NCT00890071|"     The investigators designed this study to determine the predictive value for predicting fluid     responsiveness of noninvasive evaluation of respiratory variation of peak velocity in     brachial artery, in mechanically ventilated patients with acute circulatory failure.   "
232076|NCT00890084|"     To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk   "
232078|NCT00890110|"     While different lines of evidence support the notion that renal cell cancer is amenable for     immunologic vaccination, up to now the clinical benefit associated with vaccines has been     limited. One reason being probably the whole immunological state of the patients with RCC in     which the tumor releases various substances promoting tolerance of the immune system towards     the carcinoma. Recent data demonstrates that sunitinib has effects on the immune system which     might enhance effectivity of anti tumor vaccines.      Since in kidney cancer it is quite common to resect primary tumor when there are few     metastasis or or metastatic tumor resected (if there are few metastasis), the investigators     plan to use these tumor source to grow autologous carcinoma cell lines and use a method used     world wide for many years and in our institution for over a decade to modify these cells by     dinitro phenol and use irradiated cell for patients vaccination in combination with sunitinib     treatments.      The investigators will monitor clinical and immunological parameters in these patients.   "
232079|NCT00890123|"     The perioperative administration of n-3 fatty acids has been shown to lead to favorable     effects on outcome in patients with severe surgical interventions by lowering the magnitude     of inflammatory response and by modulating the immune response. No study with preoperative     administration of IV omega 3 fatty acids as a part of total parenteral nutrition (TPN) or     monotherapy with it to demonstrate its effects on inflammatory and immune response has been     conducted. So, this study has been planned to judge the inflammatory response of preoperative     monotherapy with IV omega 3 fatty acids in elderly patients undergoing hip surgery     considering the hyper-inflammation associated with this type of surgery in elderly patients.   "
232080|NCT00890136|"     This project aims to characterize the independent effect of domestic endotoxin exposure on     health status, as well as pulmonary and systemic inflammation, in former smokers with COPD.     Positive findings from this study would be clinically relevant, as they would provide     evidence to support aggressive reduction of ongoing endotoxin exposure in patients with COPD.     The investigators also hope to make a methodological advance in the field of endotoxin     exposure assessment by elucidating whether settled dust and/or airborne endotoxin     measurements are the more relevant exposure of interest in epidemiological studies of     respiratory disease. To fulfill the specific aims, the investigators will conduct a     longitudinal study, including 75 former smokers with COPD. All subjects will have indoor air     monitoring, in-home settled dust collections, home inspections as well as assessments of     health status, quality of life (QOL), lung function and pulmonary and systemic inflammation.   "
232081|NCT00890149|"     This study will evaluate the efficacy of ondansetron + BASICS Plus in reducing severe or     binge drinking among emerging adults. BASIC Plus (Brief Alcohol Screening and Intervention     for College Students) has been the most validated brief intervention among college students.     The BASICS program provides personal feedback, motivation, and strategies that enhance     normative drinking patterns   "
232082|NCT00890162|"     Background:        -  Omalizumab is an approved drug for the treatment of asthma by the Food and Drug          Administration.        -  Researchers are now studying this drug in a double-blind placebo-controlled manner to          assess efficacy in patients with idiopathic anaphylaxis (recurrent hypersensitive          allergic episodes for which a cause is not identified).        -  The study will improve understanding of the mechanisms involved in anaphylactic          reactions as a response to the downregulation (a decrease in the number of receptors on          the surface of cells) in mast cell (a resident cell with several types of tissues)          activation, and lead to the development of strategies to better prevent or treat          anaphylaxis.      Objectives:        -  To determine whether treatment with omalizumab will reduce or prevent episodes of          unprovoked anaphylaxis (an acute allergic reaction) in subjects with a history of          idiopathic anaphylaxis.        -  To assess pharmacodynamics (physiological effects of a drug) and identify patients with          undiagnosed mastocytosis (rare disorders caused by too many mast cells).        -  To investigate cellular and molecular mechanisms of signaling and the effect of          omalizumab on mast cells or basophils (a cell in the leukocyte family that releases          histamine, which affects allergic response) and explore other regulatory pathways that          may be involved with modulation of mast cell degranulation.      Eligibility:        -  Patients between 18 and 70 years of age who have been diagnosed with idiopathic          anaphylaxis, a diagnosis that is made only after other causes of anaphylaxis have been          considered.        -  Patients with documented anaphylaxis episodes (mild to severe) at least six times within          the past 1 year period, at least once within the last 4 months, and with at least one of          the following:             -  Elevated serum tryptase above baseline within 2 hours of the event.             -  Emergency room visit with documented anaphylaxis without a known cause established               by the acute onset of an illness (minutes to several hours) with involvement of the               skin, mucosal tissue, or both (generalized hives, itching or flushing, swollen               lips-tongue-throat) and at least one of the following: (1) respiratory compromise               or gastrointestinal involvement (shortness of breath, wheeze-bronchospasm, throat               tightness, low oxygen levels, nausea, vomiting, or abdominal pain); or (2) reduced               blood pressure or associated symptoms of end-organ dysfunction (collapse, loss of               consciousness, or loss of bladder or bowel control).             -  Hospitalization for anaphylaxis.        -  Patients must provide a letter of referral, with copies of pertinent medical history and          laboratory tests, from the prospective participant s local physician, and have the          ability to give informed consent.        -  Women with childbearing potential must have a negative pregnancy test, and must agree to          practice abstinence or effective birth control from the start of the protocol and for 3          months following the last injection of the study drug.      Design:        -  Participants will undergo a clinical evaluation, blood tests, and a bone marrow biopsy          and aspirate.        -  Participants will be randomized to either drug or placebo and will receive two doses of          omalizumab or a matched placebo while hospitalized, followed by continued outpatient          therapy, every 2 to 4 weeks, for up to 6 months.        -  Participants will remain on the assigned regimen for 6 months or until they have          experienced new onset of severe adverse event on one occasion within 24 hours of study          medication that are related to the study drug, whichever comes first. At that time, the          participant will be discontinued from drug administration.   "
232083|NCT00890175|"     The purpose of this study is to assess the safety of 2 inhaled doses of Staccato Loxapine     within a day in patients with asthma.   "
232127|NCT00890747|"     This phase I trial studies the side effects and the best dose of sunitinib malate in treating     human immunodeficiency virus (HIV)-positive patients with cancer receiving antiretroviral     therapy. Sunitinib malate may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.   "
232084|NCT00890188|"     Colorectal cancer is a major health problem in Western society contributing to a high     mortality rate. Treatment options for the majority of patients with metastases are limited to     cytotoxic chemotherapies. The first line chemotherapy containing with oxaliplatin is     recommend by guideline. The use of antiangiogenic agents, either alone or in combination with     other therapies may provide an alternative treatment modality in the management of these     patients. Metronomic chemotherapy refers to the close, regular administration of a     chemotherapeutic drug, over prolonged periods. The advantages of metronomic chemotherapy     include reducing acute toxicities and sometimes surprisingly good activity against drug     resistant tumors via antiangiogenic effect.      Thalidomide is an agent, which has shown potential in the treatment of hematological and     solid tissue malignancies such as multiple myeloma via antiangiogenic mechanism.     Tegafur/uracil (UFUR) is one of the effective chemotherapeutics reported to be an effective     antiangiogenic agent in an animal model of metastatic colorectal cancers (CRCs).      In the present study, the investigators will try to use low dose metronomic schedule of     thalidomide with tegafur/uracil regimen to see the anti tumor efficacy in recurrent and     metastasis colorectal cancer patients after oxaliplatin-contained chemotherapy.      The primary endpoints are overall response rate and clinical benefit and the secondary     endpoint were to determine the progression free survival, and duration of objective response,     the overall survival (OS) and to assess the safety profile. This is a prospective phase II     study. After having checked all eligibility criteria, patients will be treated with     Tegafur/Uracil (TU) regimen. About 34 patients will be enrolled.   "
232085|NCT00890201|"     Pancreaticobiliary reflux has been found in patients with cholelithiasis and gallbladder     cancer associated with normal pancreaticobiliary union. However, the presence of     pancreaticobiliary reflux has not been studied in patients without gallstones (healthy     gallbladders).      The authors believe that pancreaticobiliary reflux might be a normal phenomenon in patients     with and without gallstones, although in patients with cholelithiasis it might constitute a     pathological condition associated with dismotility of the biliary tree and the sphincter of     Oddi.   "
232086|NCT00890214|"     The researchers investigated the influence of a prostacyclin analogue (PGIA) versus     unfractionated heparin (UFH) on ex vivo platelet function, during continuous venovenous     hemodiafiltration.   "
232087|NCT00890227|"     This research is being done to compare two methods of surgery to treat scoliosis and/or     kyphosis of the spine.   "
232088|NCT00890240|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics     (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the     body) after a single dose of JNJ-31001074. Up to three dose strengths will be tested in     patients 6-11 years old with attention deficit hyperactivity disorder (ADHD).   "
232318|NCT00893555|"     The objective of this study proposal is to determine whether pharmacologic optimization of     voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient     outcomes (efficacy and safety) and is more cost-effective compared to the current standard of     care.   "
232089|NCT00890253|"     A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a     de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy     with anti-CD25 monoclonal anti-body (basiliximab), mycophenolic acid (MPA), and mammalian     target of rapamycin (mTOR) - inhibition with everolimus to determine its safety and to     investigate the preliminary efficacy in patients with impaired renal function at the     time-point of liver transplantation (OLT) with regards to the incidence of steroid resistant     acute rejection within the first 30 days after liver transplantation.   "
232090|NCT00890266|"     Corneal ectasia is a relative weakness in the structure of the cornea, which produces a     progressive change in its shape which results in visual distortion. It is known that collagen     cross-linking in the cornea occurs naturally with age, and in diabetes, both of which seem to     prevent progressive ectasia. Corneal collagen cross-linking with riboflavin on corneas     thicker than 400 microns has been shown to stabilize the cornea in keratoconus, and prevent     progression of the disease.      The purpose of this study is to determine whether corneal collagen cross-linking with     riboflavin in a hypotonic solution, with UV light, on corneas less than 400 microns thick,     leads to stabilisation of corneal ectasia.   "
232091|NCT00890279|"     This phase II study examines the safety and efficacy of combination therapy for hypertension     in patients with autosomal dominant polycystic kidney disease (ADPKD). This study examines     the safety and efficacy of combination therapy by imidapril (ACEI) or cilnidipine (CCB) in     ADPKD patients whose blood pressure is not controlled under 120/80 mmHg by candesartan (ARB)     alone.   "
232092|NCT00890292|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics     (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the     body) after a single dose of JNJ-31001074. Up to three dose strengths will be tested in     patients 12-17 years old with attention deficit hyperactivity disorder (ADHD).   "
232093|NCT00890305|"     This clinical trial will be performed in previously untreated patients with metastatic     colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study     drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with     treatment by FOLFOX alone.   "
232094|NCT00890318|"     The purpose of this study is to determine multiple dose safety, tolerability and     pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to     determine the effect of single dose administration of ketoconazole on steady state ABT-072     pharmacokinetics.   "
232095|NCT00890331|"     Establish the efficacy of a brief, clinic-based prevention program of teamwork coping skills     for youth and their parents during in a high risk period of early adolescence (11-14 yrs)     when parental involvement and self-care deterioration occurs.   "
232109|NCT00890513|"     The primary aim of the present study is to assess satisfaction in a large sample of next of     kin in Swiss-German ICUs.      Secondary aims are to test the hypothesis that family satisfaction is related to ICU     structure and process and to factors related to patients and next of kin. Further, the     hypothesis will be tested that proxy assessment is possible, i.e. next of kin rate     satisfaction with care similar to patients.   "
232142|NCT00890955|"     Amrubicin has shown single-agent activity in lung cancer. The combination of cyclophosphamide     and anthracyclines has been studied and concluded that the combination was tolerable, could     be given safely, and therapeutically useful.      This Phase I study will evaluate the combination of cyclophosphamide with amrubicin in     relapsed solid tumors and will define the MTD of the combination in a US population.   "
232096|NCT00890344|"     Low birth weight and prematurity are associated with adverse metabolic outcome in adult life.     Yet it remains to be determined whether this outcome is the consequence of the low birth     weight per se, or of the catch up growth achieved in Neonatology units using an early,     'aggressive' nutritional management. As a matter of fact, 'aggressive' nutrition may promote     fat mass, rather than lean body mass accretion. Assessment of body composition therefore is     key to evaluate the efficacy of the nutritional management of these infants. Scarce data is,     however, available in the literature about the body composition of healthy full-term neonates     in the first few days of life.      The aim of this study is to:        1. Evaluate the feasibility and reproducibility of a safe and non invasive method of          measurement of infant body composition by Air Displacement Plethysmography (PeaPod).          Anthropometry and BIA will be used as the reference techniques to assess the accuracy of          the PeaPod        2. Describe the body composition (fat mass, fat free mass) of healthy full-term neonates in          the first few weeks of life        3. Obtain data on the total body water content of healthy full term infants from BIA.   "
232097|NCT00890357|"     The objective of this study is to identify reasons migraine patients stop using triptan     medications for abortive headache treatment. It is hypothesized that inadequate education of     the patient at the time of prescribing the triptan is positively associated with triptan     discontinuation.   "
232098|NCT00890370|"     The study was to evaluate the long term effects, over one year, of five airway clearance     techniques used by people with cystic fibrosis (active cycle of breathing techniques,     autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure     (R-C Cornet and Flutter)). The primary outcome measure was forced expiratory volume in one     second (FEV1)and the null hypothesis was that there are no differences among the regimens.   "
232114|NCT00890578|"     The use of tissue adhesives for the closure of surgical incisions is becoming increasingly     common. Several publications exist purporting the equivalence of tissue adhesive to suture     with regard to dehiscence, infection, and cosmesis. Two of the most frequently used adhesives     are Histoacryl© and Dermabond©. Despite their popularity, only one study exists comparing the     two. In this non-English study only small wounds in an exclusively pediatric population were     studied (12). Operative time, cost, and objective measures of scar size were not examined. In     the present study we aim to evaluate the relatively large surgical incisions resulting from     breast reduction, mastopexy, panniculectomy, and abdominoplasty closed with either     Histoacryl©, Dermabond©, or subcuticular suture. The primary aim is to investigate     differences in time to wound closure. Secondary aims are to compare the three approaches with     respect to cost, dehiscence, infection, scar size, and cosmesis.   "
232115|NCT00890591|"     In patients naive to treatment or after a 2-week washout period for patients whose treatment     was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme:     monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.   "
232099|NCT00890383|"     Background:      Fluid resuscitation is a cornerstone of the initial management of the critically injured     trauma patient yet there are numerous controversies surrounding this very common practice. As     a result, these controversies have been the subject of numerous clinical trials,     evidence-based guidelines and systematic reviews.      With the publication of the landmark SAFE Study the equipoise between the 2 treatments (which     were representative solutions for colloid and crystalloids respectively), 4% albumin and     saline, was established. This has however been brought into further doubt by the paucity of     data on the use of hydroxyethylstarches (HES), which are less costly and have less side     effects than albumin, in trauma. More recent findings by Gruen and colleagues have shown that     as much as 5% of all trauma deaths are the result of fluid overload based on the North     American fluid management model for trauma (pure crystalloid fluid management).      A meta-analysis done by Kern and Shoemaker found that supranormal fluid resuscitation with     crystalloids is beneficial when given before the onset of organ failure in critically ill     surgical patients. Balogh and colleagues found out that when supranormal fuid resuscitation     with crystalloids was applied to victims of severe trauma, this resulted in a statistically     significant increase in the incidence of mortality, multiple organ failure, intra-abdominal     hypertension (IAH) and abdominal compartment syndrome (ACS). More recently, Kirkpatrick and     colleagues reviewed and defined a 'secondary' ACS as a direct result of fluid resuscitation.     They concluded that excess resuscitation with crystalloid fluids might be harming patients     and contributing to an increased occurrence of ACS.      This study will serve as a pilot to test the hypothesis that there will be significant     differences in clinical outcomes for patients with severe trauma treated with colloid (HES)     plus crystalloid and crystalloid only fluid management regimens, most notably the incidence     of IAH and ACS.      It is hoped that the hybrid colloid (HES) plus crystalloid fluid management regimen will     provide a means to avoid the untoward fluid overload and/or other complications of pure     crystalloid fluid management and the costs/complications of albumin administration.   "
232100|NCT00890396|"     Sickle cell anemia (SCA) is an inherited blood disorder that can cause organ damage. The BABY     HUG study is evaluating the use of the medication hydroxyurea at preventing organ damage in     children with SCA. The purpose of this follow-up study is to evaluate the long-term effects     of hydroxyurea in children who have participated in the BABY HUG study.   "
232101|NCT00890409|"     The purpose of this study is to investigate the effectiveness and safety of selective head     cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).   "
232102|NCT00890422|"     The study aims to answer this question: whether adequate immunity can be achieved in a short     time, that is, by a rapid immunisation process, using at least one of 3 new TBE immunisation     schedules? The investigators will test the immunogenicity (the degree of immunity achieved)     of each of the immunisation schedules at various times after the injections. If the results     of this clinical study are positive, it may then be possible to develop the most successful     immunisation schedule so that it can be used routinely. This means that the results of the     clinical study have an enormous practical value in preventing TBE in people travelling or     moving into areas with a high TBE risk.   "
232103|NCT00890435|"     RATIONALE: Gathering information about why patients or their guardians agree or decline to     participate in the optional pharmacokinetic portion of a phase I treatment study may help     doctors plan clinical trials in the future.      PURPOSE: This clinical trial is looking at decision making about participating in     pharmacokinetic studies in patients enrolled in a phase I treatment clinical trial.   "
232104|NCT00890448|"     The purpose of this study is to examine the genetic contribution to the mechanism of     lapaquistat acetate- induced hepatic abnormalities.   "
232105|NCT00890461|"     The purpose of this study is to reconstruct a 12-lead electrocardiogram (ECG) from     intracardiac (IC) electrograms (EGM) obtained from defibrillator devices (ICD). The purpose     of such a reconstruction is to allow the use of IC EGM for diagnosis of clinical conditions     for which ECG have historically been used, and to test the feasibility of a reconstruction     technique for the standard 12-lead or extended electrocardiogram from electrical potentials     obtained from inside a patient.   "
232106|NCT00890474|"     Objective: To evaluate moxibustion of the BL67 acupoint between 34 and 38 weeks of gestation     to facilitate cephalic version of breech presentation in a Western setting. The hypothesis is     that moxibustion increase the likelihood of cephalic version.      Design: Randomised controlled trial Setting: University hospital. Population: A total of 212     consenting women between 34 and 36 weeks of gestation with a single fetus in breech     presentation will be randomised to moxibustion (n=106) or expectant management (n=106).      Main Outcome Measure: Cephalic presentation at delivery or before external cephalic version.   "
232107|NCT00890487|"     The purpose of this trial is to study the effects of the oral supplementation hyaluronic acid     in menopause women with vaginal distress for treatment vaginal distress.   "
232108|NCT00890500|"     The purpose of this research study is to determine the safety and efficacy of a reduced     intensity conditioning regimen during a double umbilical cord blood unit transplant with one     of the cord blood units modulated with ProHema.   "
232143|NCT00890968|"     The purpose of this study is to determine whether Triamcinolone Acetonide (TAC) DuraPeel is     safe and effective in the treatment of hand dermatitis.   "
232110|NCT00890526|"     Hyperacusis is the intolerance to sound levels that normally are judged acceptably loud to     others. The presence of hyperacusis (diagnosed or undiagnosed) can be an important reason why     some persons reject amplified sound from hearing aids. Tinnitus Retraining Therapy (TRT),     originally proposed for the treatment of persons with debilitating tinnitus, offers the     significant secondary benefit of increased Loudness Discomfort Levels (LDLs), along with     expansion of the dynamic range for loudness. TRT uses both counseling and sound therapy from     daily exposure to soft sound from bilateral noise generator devices (NGs) and has been     promoted as an intervention for hyperacusis. The hypothesis of this investigational study is     that the counseling and sound therapy principles used in TRT can be applied successfully to     treat hearing-impaired hearing-aid candidates with reduced sound tolerance who are otherwise     should benefit from hearing aids.   "
232111|NCT00890539|"     The purpose of this study is to determine the difference (if any) in the result of the     methacholine challenge (a test used by physicians in diagnosing asthma) when concentrations     of methacholine are quadrupled versus doubled.   "
232112|NCT00890552|"     This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone     (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day     cycles.   "
232113|NCT00890565|"     This study aims to evaluate the electrocardiogram (ECG) effects of Sancuso® compared to     placebo and moxifloxacin in healthy subjects.   "
232201|NCT00891943|"     The purpose of this study is to conduct a randomised controlled trial to assess the sustained     effects on weight, selected risk factors and sense of well-being of offering individualized     weight management advice in the primary care setting to patients who wish to lose weight; and     to identify the key factors influencing the success of the intervention.   "
232116|NCT00890604|"     When fever is present in patients with stroke, traumatic brain injury (TBI), or brain     hemorrhage, it has been associated with worse outcomes including larger areas of tissue     death, increased length of stay, worse degree of coma, lower ability to function, and higher     mortality. Both adult and pediatric TBI national guidelines state that maintenance of normal     body temperature should be a standard of care. However, no further standards or options are     presented to specifically guide practice. The current ischemic stroke guidelines state that     fever should be treated with fever-reducing agents and offer cooling devices as an option     but do not provide specifics to guide practice. Over 50% of patients in the Neurosurgical     Intensive Care Unit (ICU) at Harborview Medical Center develop fever during the course of     their stay. With elevated temperatures the body consumes more oxygen than if the temperature     was normal, causing less oxygen to be available to the brain. This may lead to injury of the     brain cells and a diminished capacity for healing. Thus, temperature management in     neurologically vulnerable patients is both a prevalent and problematic challenge. Based on     this information the goal of the present proposal is to evaluate if 1) A standardized,     step-wise approach to temperature management using a Normothermia Protocol is successful in     achieving and maintaining normal temperature in Neurosurgical ICU patients; and 2) If     maintenance of normal temperature will be associated with fewer episodes of diminished     responsiveness in their neurological exams as evidenced by a measure of depth of coma, as     measured by the Glasgow Coma Score (GCS) compared to a control group treated according to     usual care.   "
232117|NCT00890617|"     RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving cryotherapy before surgery     may kill more tumor cells.      PURPOSE: This phase I trial is studying how well cryotherapy works in treating patients with     primary stage I non-small cell lung cancer or lung metastasis.   "
232118|NCT00890630|"     The purpose of this study is to examine the feasibility of using intracervical balloon     catheters for cervical ripening as part of labour induction in healthy, GBS-negative women     with prelabour rupture of membranes at term.   "
232119|NCT00890643|"     In this study, the investigators are looking at how PTSD affects things such as memory,     attention, reaction to sounds, eye movements, and heart rate. The investigators are also     studying whether a medication called prazosin has an effect on these things.   "
232120|NCT00890656|"     The goal of this clinical research study is to learn if a special combination of chemotherapy     drugs called augmented hyper-CVAD chemotherapy given over 6 to 8 months followed by monthly     maintenance chemotherapy for one year can help to control acute lymphoblastic leukemia or     lymphoblastic lymphoma. The safety of this therapy will also be studied.   "
232121|NCT00890669|"     Parkinson's disease (PD) causes motor and non-motor impairments that affect the quality of     life of the subjects. The purpose was to assess the effects of treadmill walking training     with additional body load on the quality of life and motor symptoms of the subjects with PD.      Methods: Nine subjects with PD, Hoehn and Yahr stages 2 through 3, not demented and with     capability to ambulate independently voluntarily participate in this study. The training     program was divided into three phases (A1-B-A2): treadmill training with additional body load     (A1), control condition (conventional physical therapy group) (B) and treadmill training with     load again (A2). Each phase lasted six weeks. The quality of life and motor symptoms were     assessed by PDQ-39 and UPDRS, respectively. Both evaluations and training were performed     during on-phase of the medication cycle.   "
232122|NCT00890682|"     After undergoing bunion surgery, patients are given a pain medicine injection that may last     for up to several days or a placebo. Their pain and pain medicine use is then monitored.   "
232713|NCT00899691|"     RATIONALE: Studying samples of hair in the laboratory from patients with cancer may help     doctors identify biomarkers related to cancer and predict how well patients will respond to     treatment.      PURPOSE: This laboratory study is looking at hair samples from patients with cancer.   "
232128|NCT00890760|"     Malaria affects around 515 million people each year, about a million of whom die from the     disease. It is a major problem for those who live in affected areas as well as for travellers     to affected areas. There is a great need for a safe, effective malaria vaccine. The purpose     of this study is to test 2 new vaccination regimes that include a new malaria vaccine     candidate, for their ability to prevent malaria infection.      The vaccines are different types of virus which contain genetic information (DNA) from the     malaria parasite. This genetic material is named ME-TRAP. The aim is to use these viruses to     help the body make an immune response against the malaria parasite. Both viruses are     inactivated so that they are unable to multiply within the body.      The first vaccine virus is a weakened version of a common cold virus. Such adenoviruses occur     in many strain types and commonly infect chimpanzees as well as people and this vaccine uses     a strain originally derived from a chimpanzee. The vaccine is called AdCh63 ME-TRAP.      The other virus is Modified Vaccinia Ankara Virus, (MVA), which is a safer form of the     vaccine virus previously widely used for smallpox vaccination. The vaccine is called MVA     ME-TRAP.      This study will enable the investigators to assess:        1. The ability of different vaccine combinations to prevent malaria infection        2. The safety of the vaccine combinations in healthy volunteers        3. The response of the human immune system to the vaccines   "
232129|NCT00890786|"     The outcome for children with high-grade gliomas and diffuse intrinsic brainstem gliomas     remains poor despite the use of multi-modal therapy with surgery, radiation therapy and     chemotherapy.   "
232130|NCT00890799|"     The purpose of this study is to investigate effectiveness and safety of transcatheter closure     of perimembranous ventricular septal defects.   "
232131|NCT00890812|"     The purpose of this study is to evaluate the utility of measuring coagulation factor     activities in the setting of acute ischemic stroke, as potential markers of inherited     thrombotic risk. The investigators will determine if relationships exist between coagulation     factors, including factor VIII, factor IX, and factor XI and clinical diagnosis,     classification, and outcome. The investigators will determine if any significant elevations     of these factor activities are independent thrombotic risk factors.      Null Hypothesis: There is no statistical difference between coagulation factors, including     factors VIII, IX, or XI activity levels in patients having acute ischemic stroke as compared     to acute stroke mimics.   "
232132|NCT00890825|"     The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel     versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic     non small cell lung cancer.   "
232133|NCT00890838|"     The perioperative administration of n-3 fatty acids has been shown to lead to favorable     effects on outcome in patients with severe surgical interventions by lowering the magnitude     of inflammatory response and by modulating the immune response. To the investigators'     knowledge, no study with preoperative administration of intravenous (IV) omega 3 fatty acids     as a part of total parenteral nutrition (TPN) or monotherapy with it to demonstrate its     effects on inflammatory and immune response has been conducted. So, this study has been     planned to judge the inflammatory response of preoperative monotherapy with IV omega 3 fatty     acids in elderly patients undergoing valvular surgery considering the hyperinflammation     associated with this type of surgery in elderly patients.   "
232134|NCT00890851|"     The TUNA is a known and already old technique. There exists, in the literature, a certain     number of studies showing the long-term effectiveness (5 years), evaluated on the IPS and the     flow mictional.This effectiveness is slightly lower than that of the endoscopic resection of     prostate. This technique does not present the disadvantages of the surgery prostate sufferer     on ejaculation. Moreover, it can be carried out in short hospitalization or ambulatory as it     is the case in particular in the States Unis. The aim of the study which will be led by the     AP-HP will be thus to test the feasibility of the TUNA during a hospitalization of less 24     hours.   "
232135|NCT00890864|"     The purpose of this pilot study is to assess the feasibility and acceptability of randomising     the phasing-in of the age extension of the NHS Breast Screening Programme in six volunteer     sites in different areas of England.   "
232136|NCT00890877|"     This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of     three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist     drugs alone. This study will compare the patients on OC000459 at three different dose levels     (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after     dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment     arm will consist of at least 110 subjects. The objective is to assess the efficacy of these     dose levels on the patients asthma.   "
232137|NCT00890890|"     The purpose of this study is to determine the safety and tolerability of BMS-708163 in     patients with Prodromal Alzheimer's disease over a treatment period of a minimum of     104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post     treatment.   "
232138|NCT00890903|"     The purpose of this non-interventional study is to collect data on efficacy and toxicity of     the use of Navelbine ORAL in daily routine in Germany (especially after availability of an     80mg capsule). The study focusses on concomitant antiemetic therapy and patient compliance.   "
232139|NCT00890916|"     The purpose of this study is to evaluate the effectiveness of an implanted stimulator for     providing hand function to individuals with cervical level spinal cord injury. The device     stimulates the paralyzed muscles of the hand and forearm. The user of the device controls the     stimulation by moving muscles that are not paralyzed, such as a wrist or neck muscle. The     ability of the user to pick up and move objects, as well as perform various activities such     as eating, drinking, and writing.   "
232140|NCT00890929|"     This study has a phase 1 and a phase 2 component.      In phase 1, the objective is to determine the maximum tolerated dose (MTD) of lenalidomide     when after azacitidine.      In phase 2, the objective is to determine the efficacy of the combination treatment.   "
232141|NCT00890942|"     The purpose of this study is to determine whether intramuscular naloxone 0.4mg. is effective     in prophylaxis of intrathecal morphine induced pruritus after cesarean section.   "
232180|NCT00891319|"     Impaired hand function is one of the most frequently persisting consequences of stroke. The     purpose of this study is to compare two different treatments -- Contralataterally Controlled     Functional Electrical Stimulation (CCFES) and Cyclic Neuromuscular Electrical Stimulation     (cNMES) -- for improved recovery of hand function after stroke.   "
232144|NCT00890981|"     To evaluate the combined effect of denosumab treatment and discontinuation on cortical     thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography     (HR-pQCT). Participants randomized to either denosumab or placebo in the 20050179     (NCT00293813) study who completed that study (ie, attended an end of study visit) can be     included in this study. At least 12 months should have elapsed since the patient's 20050179     end of study visit.   "
232145|NCT00890994|"     In this research study, the investigators are testing a new type of breast camera, called     Molecular Breast Imaging, to see if it can find tumors in the subject's breast.   "
232146|NCT00891007|"     Partially randomized, controlled Phase II study to evaluate safety, immunogenicity and dose     response of the measles vaccine MVA mBN85B in healthy children aged 6 months to 6 years.   "
232147|NCT00891020|"     This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of     tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had     inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk     mitigation strategies developed in partnership with the FDA to manage known and potential     risks associated with the treatment of tocilizumab. Patients will be randomized to receive     tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic     DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of     6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample     size is 500-1000 individuals.   "
232148|NCT00891033|"     Multiple myeloma (MM) accounts for approximately 1% of all malignancies and 10% of     hematological tumors, representing the second most frequently occurring hematological     malignancy in the United States. At any one time, 50,000 people suffer from MM, and     approximately 15,000 are diagnosed each year. The median age is approximately 65 years,     although occasionally MM occurs in the second decade of life.      Bortezomib and panobinostat intravenous (IV) are active agents in multiple myeloma and appear     to work through different biochemical pathways, suggesting that there may be a synergistic     effect using the combination. Both compounds have shown anabolic bone effect, which has been     associated to significant anti-myeloma activity.      Primary objectives:        -  To assess the toxicity of bortezomib combined with one of 4 doses of panobinostat IV in          patients with relapsed/refractory multiple myeloma, and        -  To find the most appropriate doses of bortezomib and panobinostat IV in the combination.      Secondary objective:        -  To assess the effect of bortezomib in combination with panobinostat IV on inducing          osteoblast activation in patients with relapsed/refractory myeloma.   "
232149|NCT00885443|"     Emergence delirium (ED) refers to a wide variety of behavioural disturbances that are     commonly seen in children following emergence from anesthesia. ED can potentially be     dangerous and have serious consequences for the child such as injury, increased pain, and     dislodgement of medical devices, often requiring physical restraint or pharmacological     control. Witnessing this behaviour can be stressful for parents, which can negatively affect     their interaction with the healthcare system, and their relationship with the child, nursing     staff and other healthcare providers. The investigators aim to minimize ED to reduce the     distress experienced by patients and their parents. This study will compare the recovery     profile of sevoflurane with that of propofol remifentanil and their associated incidence of     ED. This study should enable us to determine which form of anesthesia is associated with the     fewest incidences of ED in children.   "
232150|NCT00885456|"     The objective of the Program of Rehabilitative Exercise and Education to avert Vascular     Events after Non-disabling stroke and Transient ischemic attack (PREVENT) Trial is to     determine whether the timely delivery of secondary stroke prevention strategies will reduce     modifiable vascular risk factors in two groups of people who have survived NDS or TIA. One     group will receive a comprehensive education and exercise program (PREVENT); the other group     will receive usual care (USUAL CARE). We will measure modifiable vascular risk factors in     both groups. We will also compare the effects of PREVENT vs USUAL CARE on exercise capacity,     walking endurance, and daily physical activity. In addition, we will compare thinking     ability, depression, achievement of personal goals for healthy behavior, and health-related     goal attainment and health-related quality of life. Finally, we will compare outcomes in     urban and rural settings as well as costs of the PREVENT program and USUAL CARE in order to     assess sustainability of the PREVENT program.   "
232151|NCT00885469|"     Study Hypothesis:        -  PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded          esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting          and grading esophagitis.        -  PillCam™ ESO will demonstrate all safety parameters as compared to EGD        -  PillCam™ ESO-2 will demonstrate better patient's satisfaction as compared to EGD   "
232152|NCT00885482|"     Objectives of the study:        1. To verify the safety of the study treatment, defined as the persistent control of the          virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with          ritonavir.        2. To collect relevant information about the safety and the metabolic impact of this          strategy in order to eventually design a non-inferiority randomized controlled trial for          the evaluation of the safety and the efficacy of this strategy in the future.   "
232153|NCT00885495|"     This is a phase I, open-label, controlled drug interaction study to determine the effects of     darunavir plus ritonavir on the pharmacokinetics of the hydroxymethylglutaryl coenzyme A     (HMG-CoA) reductase inhibitor, rosuvastatin, in HIV-1-seronegative subjects.   "
232154|NCT00885508|"     In this trial, the investigators will test the combination of escalating doses of     chemotherapy (starting at relatively low dose) with lenalidomide in intermediate-2-or high     risk MDS and AML with del 5 q31. It is hoped that this combined therapy will further increase     response rate in intermediate-2-or high risk MDS and AML with del 5 q31, without major     toxicity in comparison to historical results obtained with chemotherapy alone in the same     subset of patients.   "
232181|NCT00891332|"     This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1     week on and 1 week off) as first -line treatment for patients with metastatic colorectal     cancer.   "
232358|NCT00894075|"     This Clinical Trial is being conducted to study Hypophosphatasia (HPP), a bone disorder     caused by gene mutations or changes. These gene mutations cause low levels of an enzyme     needed to harden bone. The purpose of this study is to test the safety of the study drug     called ENB-0040 and see what effects is has on human juveniles and HPP.   "
232155|NCT00885521|"     The aim of this project is to examine the short and long term effects of an 8 week, twice     weekly, outpatient exercise training program for people with bronchiectasis. Participants     will be randomly allocated to undergo a supervised exercise training program at The Alfred,     Austin Hospital or Sir Charles Gairdner Hospital.      The hypotheses of this study are:        1. Patients with bronchiectasis who complete an exercise program will have a higher          exercise capacity and better quality of life and these improvements will be sustained          for up to 12 months after completion        2. Exercise training will significantly reduce the incidence of pulmonary exacerbations,          use of antibiotics and rate of hospitalisation   "
232156|NCT00885534|"     The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT     is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other     investigators have used CVT in melanoma patients and found that tumors got significantly     smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of     how many patients will respond to CVT. Also they want to test which genes in the tumor are     turned on and which are turned off. We hope this will teach us to know in the future which     tumors will respond to CVT.   "
232157|NCT00885547|"     The purpose of this study is to:        1. To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic          abnormal urinalysis.        2. To evaluate the safety and tolerability of TW.   "
232158|NCT00885560|"     To enhance our capacity to correctly choose the appropriate medication for ADHD patients on     the first try based on the presence of a particular variant of a gene that could be     identified on a laboratory test. It is hypothesized that patients with Attention Deficit     Hyperactivity Disorder (ADHD) who have failed to respond to methylphenidate medication, but     do respond to amphetamines, have a higher than expected incidence the allelic variants of the     SNAP 25 gene associated with ADHD, and mutations of the dopamine system genes DRD1, 2, 4, 5     and dopamine transporter and COMTand MAOA.   "
232168|NCT00891150|"     The goal of this study is to determine the best dose of a drug called oxytocin, that is     usually used to stop bleeding during a delivery, when used during a cesarean delivery. It     will be administered during cesarean section in order to decrease the amount blood loss. The     investigators are proposing to have 3 groups of subjects each given a different safe dose of     oxytocin and then to assess the effectiveness of each regimens on the amount blood lost     during cesarean sections.This will let use know which is the best lowest dose needed.   "
232159|NCT00885573|"     Pharyngeal sensitivity is a determinant parameter of pharyngeal functioning, particularly     regarding protective dilator reflexes of upper airway. Preliminary results have suggested     that the use of this parameter in diagnosis algorithm such as linear discriminant analysis     and random forest could predict the presence of sleep apnea syndrome in almost 98% of     patients. Our study aims at validating a new diagnosis method of sleep disordered breathing     which will be compared with nocturnal polysomnography, the reference method to diagnose sleep     disordered breathing. Pharyngeal sensitivity will be measured using the SENSITEST device     which allows an automatic measurement of the pharyngeal sensation. The use of this parameter     in diagnosis algorithm will be compared with polysomnographic results.   "
232160|NCT00891046|"     This open-label extension study will permit patients with Systemic Juvenile Idiopathic     Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab     treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg     s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or     when study CACZ885G2402 is in place at their study center or around March 2013, whichever     occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2     mg/kg s.c. every 4 weeks.   "
232161|NCT00891059|"     The Diskus Inhaler is administered by a nurse or medical technician in the Nursing Home (NH)     setting. The administration of the medication from the Diskus Inhaler includes 4 steps: open,     click, inhale, close. The only step that the resident must do is the inhale step, which     includes holding one's breath for 10 seconds after the inhalation.      The investigators propose that properly trained and motivated nurses and medical technicians     can successfully administer medication using the Advair Diskus to almost any mildly to     moderately cognitively impaired resident who can follow the instruction- inhale and hold     your breath for 10 seconds. The objective is to show that mild to moderate cognitive     impairment should not be a barrier to the use of Diskus Inhaler. There will only be 1 consent     visit and 1 evaluation visit per subject.   "
232162|NCT00891072|"     This phase I trial is studying the side effects and best dose of gossypol when given together     with paclitaxel and carboplatin in treating patients with solid tumors that are metastatic or     cannot be removed by surgery. Drugs used in chemotherapy, such as gossypol, paclitaxel, and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving gossypol together with paclitaxel and     carboplatin may kill more tumor cells   "
232163|NCT00891085|"     The purpose of this study is to collect data on patients who are on breathing machines     (ventilators) in the Trauma Surgical Intensive Care Unit (TSICU). This data may help us to     determine if one form of assisted breathing is better than another. The two forms of assisted     breathing being compared in this study are called BiVent and SIMV. (7) BiVent and SIMV are     both delivered by a ventilator but differ in how they assist breathing. SIMV is an older form     of mechanical breathing that blows air into the lungs to inflate the lungs. BiVent is a newer     form of mechanical ventilation that permits the patient to pull air into the lungs as we     normally do. Both BiVent and SIMV are currently being used on a regular basis in the TSICU.     The investigators hope that this study will determine if one method of assisted breathing is     better than another in preventing complications associated with mechanically assisted     breathing.   "
232164|NCT00891098|"     The outcome of trauma treatment (Posttraumatic Stress Disorder - PTSD) may be influenced by     which emotions that are predominant among current symptoms, e.g. fear, anger, guilt, shame.     Different treatment procedures for processing traumatic memories may resolve different     emotions. This study compares two different treatment procedures of working with trauma     memories in PTSD treatment (namely, Imaginal Exposure and Imagery Rescripting) in order to     test this.   "
232182|NCT00891345|"     This study is a phase I study of a new cell based prostate cancer therapy (ALECSAT). In this     therapy specific cells from the patient's own immune system are isolated, activated and     re-administered to the patient to boost a specific immune response against the cancer cells.     The aim of the study is to show safety and tolerability for this type of therapy. It is the     hypothesis that the cells administered during the therapy will attack the tumour cells and in     this way stop or slow down the progression of disease.   "
232359|NCT00894088|"     The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg     tablets under fasted conditions.   "
232165|NCT00891111|"     The purpose of this study is to understand using incentives to encourage employees to     increase participation in an aspect of a corporate wellness program - filling out health risk     assessments. This study will test whether lottery-linked incentives are more effective than     guaranteed incentives in encouraging people to fill out health risk assessments.      This study will be run in an employer setting in which rates of health risk assessment     completion are suboptimal. This study would be conducted within a workplace setting in which     the firm is divided into a number of geographically situated and functionally related     subunits. The investigators will run a complete your health risk assessment now! program     for 4 weeks. Each work unit will obtain a symbol. Every week, one symbol will be randomly     drawn, publicly announced, and anyone in that work unit at the firm who has received their     preventive screening would receive a $100 prize. In addition, if all of employees in that     unit have completed their forms, then the prize will be increased to $125.      The investigators expect this condition to result in greater compliance compared to a control     condition in which employees would receive weekly reminders and a direct payment of a $25     gift card for completing the form at anytime during the 4 weeks of the study. This is     analogous to direct payments that have been used by insurers to encourage completion of such     forms in other contexts.   "
232166|NCT00891124|"     This study will address the proportion of achievement patients in treatment target goal on     glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline, among     outpatients coming to the Korean primary care nationwide.   "
232167|NCT00891137|"     Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to     accelerate neutrophil recovery in patients receiving myeloablative conditioning as part of an     umbilical cord blood transplant for hematologic cancer. In this study, the safety and     tolerability of CLT-008 administered 24 hours after an umbilical cord blood transplant will     be determined by monitoring for adverse reactions, neutrophil and platelet recovery,     hematopoietic chimerism, graft-versus-host disease (GVHD), and infections.   "
232170|NCT00891176|"     This protocol posting deals with objectives & outcome measures of an extension phase when     subjects are aged 3, 4 and 6 years of age. The objectives & outcome measures of the primary     phase are presented in a separate protocol posting (NCT number = NCT00334334). The objectives     & outcome measures of the booster phase are presented in a separate protocol posting (NCT     number = NCT00463437).      The purpose of this study is to evaluate the persistence of pneumococcal, meningococcal     serogroup C, Hib and Hepatits B antibodies after booster vaccination, when the subjects are     aged 3, 4 and 6 years. No vaccine will be administered during this persistence phase of the     study.   "
232171|NCT00891189|"     Asthma is a disease that affects the lungs. Symptoms include repeated episodes of wheezing,     breathlessness, chest tightness, and nighttime or early morning coughing. Some people with     asthma experience worse symptoms at night, which is known as nocturnal asthma (NA). The     reason for the decline in lung function at night in some asthmatics is not well understood,     but it may be linked to the human biological clock, which controls daily activity and sleep     rhythms. To determine whether differences in biological clocks relate to worsening nocturnal     lung function, this study will evaluate the circadian rhythms of people with NA, people with     non-nocturnal asthma, and healthy people.   "
232172|NCT00891202|"     This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate     (Genz-112638) in participants with Gaucher disease Type 1.   "
232173|NCT00891228|"     To determine the number of men who have suppression of sperm production when using a daily     regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.   "
232174|NCT00891241|"     The purpose of this clinical study is to estimate the radiation dosimetry of a single dose of     LMI1195 in healthy subjects and heart failure patients undergoing positron emission     tomography (PET)   "
232175|NCT00891254|"     The intraperitoneal repair has been proven safe for the repair of incisional hernia and is     accepted, together with the subfascial or retromuscular repair as the gold-standard for the     repair of incisional hernia. However no studies have convincingly proven that this approach     is better than the on-lay repair.      The authors believe that the intraperitoneal repair performs better than the on-lay repair     for incisional hernia.   "
232176|NCT00891267|"     The purpose of this study is to study the effect of two doses of olmesartan medoxomil and     amlodipine on vascular markers in hypertensive patients with metabolic syndrome.   "
232177|NCT00891280|"     This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability and highest     safe dose level of this CK2 inhibitor in patients with advanced solid tumor cancers,     Castleman's Disease or Multiple Myeloma.   "
232178|NCT00891293|"     This was a 24-month, open-label extension study that followed an 8-week double-blind study     (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study     LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid     ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum     triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone.     This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza     (omega-3-acid ethyl esters) [formerly known as Omacor] therapy in hypertriglyceridemic     subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.   "
232179|NCT00891306|"     This trial is designed to expand the currently available data on the safety and efficacy of     alipogene tiparvovec treatment in lipoprotein lipase deficiency (LPLD) and to further the     understanding of possible mechanisms of action of the therapy.   "
232183|NCT00891358|"     This study will begin to develop a culturally appropriate secondary prevention intervention     for young HIV+ women through focus groups.      Using three intervention sites, focus groups will guide the development of the intervention's     framework and content areas. An intervention will be developed/adapted through the data     collected in the focus groups and review of relevant interventions. The intervention aims to     address the following concerns: 1) reducing the risk of young women infected with HIV     transmitting the virus to their sexual partners, and 2) preventing young women infected with     HIV from re-infection with a new viral strain or co-infection with another sexually     transmitted disease.   "
232184|NCT00891371|"     The purpose of this study, is to assess the effect of lanreotide Autogel 120mg on stool     frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to     baseline.   "
232185|NCT00891384|"     This trial is a randomised, parallel-group, multicenter phase III study for maintenance     therapy with lenalidomide in patients with multiple myeloma who were treated with high-dose     therapy and autologous stem cell transplantation as first line therapy.   "
232186|NCT00891748|"     The study objective is to evaluate the feasibility of three instillations of     immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance,     toxicity and immunological parameters will be evaluated during and post treatment.   "
232187|NCT00891761|"     This is a phase III study designed to demonstrate the superiority of single-dose 90 mg     intravenous (IV) casopitant over placebo, each in combination with ondansetron and     dexamethasone, for the prevention of emesis over the first 0-120 hours (overall phase)     following initiation of the cisplatin infusion in the first cycle of highly emetogenic     chemotherapy (HEC). Eligibility is limited to subjects who are scheduled to receive their     first cycle of chemotherapy which includes at least 60 mg/m2 of cisplatin administered on Day     1 only of a 21 day or 28 day cycle. All subjects will receive IV ondansetron and oral     dexamethasone on Day 1 prior to initiation of the cisplatin infusion, followed by oral     dexamethasone on Days 2-4. Additionally, subjects will be randomized to receive single-dose     90 mg IV casopitant or matching placebo prior to initiation of a cisplatin-based HEC regimen.   "
232188|NCT00891774|"     Approximately 165 subjects with Fitzpatrick Skin Color Types IV, V, and VI and a moderate to     deep wrinkle between the corner of the nose and the corner of the mouth, will be treated with     EVOLENCE® (an approved collagen filler) to smooth and flatten that wrinkle. They will be     observed for 6 months to establish safety of the product as it relates to scarring and     changes in skin pigment, and long term effectiveness.   "
232212|NCT00892112|"     A prospective randomized double-blind placebo-controlled trail to investigate the effect of     high doses of IVIg on cardiac functional capacity and virus presence in a subgroup of     patients with chronic symptomatic ICM and a high PVB19 load in the heart.   "
232189|NCT00891787|"     Background:        -  Probiotics are oral food supplements containing live bacteria that may be beneficial to          a person s digestion or general health. Probiotics are available as tablets, powder, or          liquid supplements and are frequently used to supplement yogurt. They are available for          purchase without prescription in most supermarkets.        -  The bacteria in probiotic supplements commonly express sugar substances on their          surface. These sugar substances are similar to group A and B blood group sugars, called          antigens. These antigens determine a person s blood group. Researchers are studying the          effect of probiotic supplements on the amount of blood group antibodies that are present          in a person s blood.      Objectives:        -  To determine whether taking oral probiotic supplements increases anti-A and anti-B          isoagglutinins (antibodies that cause red blood cells to clump together) in healthy          subjects.        -  To study the frequency of these effects and determine whether there is a dose-response          relationship with probiotics and isoagglutinin titers.      Eligibility:        -  Healthy adults, 18 years or older, with type A, B, or O blood.        -  Female participants need to have undergone menopause or have had a hysterectomy.        -  Individuals are ineligible if they currently donate platelets; have a history of          ulcerative colitis or Crohn s disease; have had major bowel surgery; are pregnant or          capable of becoming pregnant; have a bleeding or clotting disorder; have a history of a          blood disorder or immune deficiency; have a history of high-risk behaviors for exposure          to HIV or hepatitis B or C; have diabetes; have received vaccinations in the past 2          months, with the exception of the flu vaccine; are currently taking immunosuppressive          medications; are currently taking antibiotics; or have taken probiotic supplements          within the last 12 months.      Design:        -  Researchers will conduct the following tests throughout the 28-week study:             -  Blood samples will be drawn every 2 weeks to measure the quantity of isoagglutinin               titers.             -  Depending on individual results, continued blood testing may be done every 3 months               for 1 year, then every 6 to 12 months for up to 5 years.        -  Study subjects will take a probiotic supplement at a dose of 1 to 3 caplets per day for          18 consecutive weeks according to the following schedule:             -  During the first 6-week period, the subject will take one probiotic tablet daily.             -  During the second 6-week period, the subject will take one probiotic tablet twice               daily.             -  During the third 6-week period, the subject will take one probiotic tablet three               times daily.        -  Control group subjects will be followed in a similar manner but will not take probiotic          supplements.        -  The outcome measure is the percent of probiotic ingestors (the study subjects) versus          control group subjects who experience a fourfold or greater rise in isoagglutinin titer.        -  Study subjects will receive the following financial compensation: $10 per blood sample,          for a maximum of $240 if all 24 samples are collected; $100 after completing the first          6-week period; $150 after completing the second 6-week period; and $200 after completing          the third 6-week period.        -  Control subjects will receive $10 per blood sample, for a maximum of $150 if all 15          samples are collected.   "
232190|NCT00891800|"     The purpose of this study to study whether or not the use of direct radiation therapy with     Y-90 microspheres (SIR-Spheres) has any effect on treated liver with respect to tumor     response in breast cancer patients.      Criteria:        -  Breast cancer        -  Clinical evidence of metastatic disease in the liver        -  Performance status (0-2)        -  Not pregnant        -  Laboratory values received after any prior chemotherapy        -  Normal Pt/PTT        -  recovered from any chemotherapy side-effects        -  No prior radiation therapy to the liver        -  No other MAJOR site of cancer such as lungs or brain        -  No uncontrolled infections        -  a candidate for surgical resection or ablation therapy   "
232191|NCT00891813|"     The purpose of this study is to observe the effectiveness and safety of the use of a low     initial dose regime (iPTH/100) in chronic kidney disease patients with secondary     hyperparathyroidism (PTH>300pg/mL) and that require dialysis at least 3 times per week.   "
232192|NCT00891826|"     This study sets out to test the hypothesis that parameters of heart rate variability, as a     non-invasive measure of cardiovascular risk, can be improved by the addition of omega-3 fatty     acids in euthymic bipolar patients with a low omega-3 index and reduced heart rate     variability.   "
232193|NCT00891839|"     The purpose of this study is to determine the efficacy and safety of the combination of     bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma.   "
232194|NCT00891852|"     The overall significance of this study is to develop a laboratory developed test (LDT) to use     a new marker in the maternal blood to better identify pregnancies that have a child with a     chromosome abnormality such as Down syndrome (trisomy 21), Edward's syndrome (trisomy 18),     Patau syndrome (trisomy 13), Klinefelter syndrome, (47, XXY), and other chromosome     abnormalities. Accomplishing that task would reduce the need for invasive amniocentesis and     CVS procedures.   "
232195|NCT00891865|"     The purpose of this study is to determine whether respiratory viral infections increase the     risk of bronchiolitis obliterans syndrome (BOS), obliterative bronchiolitis (OB), death, or     retransplantation in children who have received lung transplants.   "
234966|NCT00928785|"     The purpose of this study is to demonstrate that a combined adult Tdap-IPV vaccine (REPEVAX®)     will provide similar rapid antibody responses against tetanus toxoid as a tetanus toxoid     vaccine alone in healthy adults.   "
232196|NCT00891878|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor. It is not yet known whether     capecitabine is more effective when given alone or together with sunitinib malate in treating     patients with metastatic esophageal cancer or gastroesophageal junction cancer.      PURPOSE: This randomized phase II trial is studying how well capecitabine works compared with     capecitabine given together with sunitinib malate as first-line therapy in treating patients     with metastatic cancer of the esophagus or gastroesophageal junction.   "
232197|NCT00891891|"     The purpose of this longitudinal study is to evaluate a developmentally-oriented     bio-neuropsychological model of adjustment in youth and young adults with spina bifida. The     theoretical framework for the study is a developmentally-oriented bio-neuropsychosocial model     of psychological adjustment.   "
232198|NCT00891904|"     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the     tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells.      PURPOSE: This clinical trial is studying the side effects of radiation therapy given together     with cetuximab and to see how well it works in treating patients with recurrent head and neck     cancer.   "
232199|NCT00891917|"     The purpose of this study is to measure the effects of LiQ-NOL supplementation on language     production using the Clinical Evaluation of Language Fundamentals test, language sampling     using the mean length of utterance test, and speech articulation using the Goldman-Fristoe     Test of Articulation.   "
232200|NCT00891930|"     This study is designed to evaluate the mechanism(s) of resistance to the anti-epidermal     growth factor receptor (EGFR) antibody panitumumab given in combination with irinotecan in     metastatic colorectal carcinoma (mCRC) patients with wild-type Kirsten rat sarcoma-2 virus     oncogene (KRAS) tumor status at the time of initial diagnosis.   "
232213|NCT00892125|"     The purposes of this study are to evaluate the effects of a potent metabolic enzyme inducer,     carbamazepine, on the steady-state pharmacokinetics of orally administered paliperidone ER     and to evaluate the safety and tolerability of the treatments in clinically stable patients     with a diagnosis of schizophrenia or bipolar I disorder.   "
232202|NCT00891956|"     Background:        -  Rett syndrome (RS) is a panethnic (affecting all ethnicities) neurodevelopmental          (impairment of the growth and development of the brain) disorder affecting primarily          females. RS is characterized by the loss of intellectual functioning, fine and gross          motor skills, and communicative abilities after a period of seemingly normal          development.        -  Caregivers of individuals with RS face many psychosocial challenges. The stressors can          be grouped into the following six categories: emotional difficulties, health-related          stressors, uncertainty about their daughter s illness, rejection by their social          environment, lack of available or competent experts, and unfavorable comparison with          healthy children.        -  Researchers are making a significant contribution to the adaptation literature with a          focus on family functioning and to the little psychosocial research that exists on          families with RS.        -  Researchers hope to narrow down the most important areas on which to focus for          intervention strategies in families with RS.      Objectives:        -  To describe family functioning, perceived illness burden, self-efficacy, types of coping          methods, and adaptation in caregivers of individuals with RS to examine the          relationships between these variables and the outcomes of family functioning and          adaptation.        -  To examine the extent to which appraisals of being a caregiver of an individual with RS          and methods of coping are associated with family functioning.        -  To examine the extent to which appraisals of being a caregiver of an individual with RS,          methods of coping, and family functioning are associated with caregiver adaptation.      Eligibility:      - Eligibility is based on answering yes to the following three questions: Are you 18 years     old or older? Are you the caregiver of a child diagnosed with Rett Syndrome? and Does the     child with Rett Syndrome currently reside in your home with you?      Design:        -  Participants in this cross-sectional research design will answer a quantitative survey          that includes some open-ended questions. The cross-sectional study involves a one-time          self-administered questionnaire that takes approximately 20 to 30 minutes to complete.        -  The survey will be available in paper and electronic versions and includes demographics          questions, measures of perceived illness burden, parental self-efficacy, coping methods,          family functioning, and adaptation. Participants also will answer open-ended questions          related to the individual s diagnosis.        -  Participants may withdraw from the study at any point up until submission of the survey          and may skip any question.        -  Participants who experience psychological distress as a result of taking the survey are          advised to contact the researcher. Study coordinators at the various clinics from which          participants will be recruited will be notified of the possibility of adverse events and          instructed to direct any members who experience distress to the appropriate professional          services.        -  Participants will receive a small financial compensation for completing the survey.   "
232203|NCT00891969|"     RATIONALE: A study that looks at communication between patients and doctors may help     oncologists improve patient satisfaction with their treatment plan.      PURPOSE: This phase I trial is studying treatment decision making between oncologists and     women with newly diagnosed breast cancer and their healthy companions.   "
232204|NCT00891982|"     The purpose of this study is to evaluate the tolerability of a combined regimen of a topical     antibiotic and retinoid and a benzoyl peroxide wash.   "
232205|NCT00891995|"     The purpose of this study is to find out if very tight blood glucose control from the onset     of Type 1 Diabetes can preserve beta cell function. Study subjects will be randomly assigned     to receive either standard diabetes management or intensive diabetes management, which     involves several days of closed loop therapy followed by home use of a continuous glucose     monitor and insulin pump.   "
232206|NCT00892008|"     This study is being conducted as a regulatory requirement post initial marketing     authorization. This is primarily a safety study. This was an open label study and patients     were enrolled once the decision to prescribe the medication was made by the Investigator.   "
232207|NCT00892021|"     This study will evaluate the safety of multiple doses of NSA-789 in subjects with     schizophrenia or schizoaffective disorder. This study will also assess how NSA-789 is     absorbed and eliminated, and its effect, if any, on the brain.   "
232220|NCT00892216|"     Post-operative nausea and vomiting (PONV) is not only unpleasant for patients but also can     delay hospital discharge and increase cost of stay. In some cases, when severe vomiting     occurs, pain scores seem to be increased. The overall incidence of PONV is 30% and increases     to 79% in patients at high risk for this post-operative outcome. The NUSS procedure is     considered to be a procedure with a high risk for the outcome of nausea and vomiting.   "
232221|NCT00892229|"     The purpose of this study is to determine the effectiveness of buccal misoprostol and     comparing this with vaginal route of the same drug.   "
232222|NCT00892242|"     The overall purpose of this research is to evaluate the safety and side effects of zoledronic     acid (also known as Zometa) in patients before they have surgery to remove the cancer.   "
232208|NCT00892047|"     The primary aims of this study are to:        1. Assess the efficacy of aripiprazole augmentation for the acute and continuation          treatment of TRLLD.           Hypothesis 1: Patients with TRLLD (defined as those who do not remit after 12 weeks of          acute treatment with venlafaxine XR) will have a higher rate of remission with          aripiprazole than with placebo augmentation (primary outcome) and greater improvement in          depressive symptoms and stability of remission (secondary outcomes).        2. Assess the tolerability of aripiprazole in TRLLD with a focus on adiposity and          akathisia/restlessness.      Hypothesis 2: Aripiprazole will be associated with a higher rate of clinically significant     akathisia and increased adiposity than placebo.      The Secondary/exploratory aims of this study are to:        1. Examine anxiety, medical burden, and executive impairment as moderators of aripiprazole          augmentation efficacy in TRLLD.           Hypothesis 3: Pre-levels of anxiety symptoms, medical burden, and executive impairment          will be treatment-specific factors: they will moderate the efficacy of aripiprazole          augmentation. The aripiprazole-placebo difference will be greater in individuals with          these variables, compared to those without these variables because these three factors          will be associated with a decreased likelihood that staying the course with          venlafaxine monotherapy will achieve remission.        2. Examine genetic predictors (phase 1) and moderators (phase 2-3) of treatment outcomes,          while controlling for drug exposure.      Hypothesis 4: Selected polymorphisms will reduce remission rate with venlafaxine and will     reduce efficacy and tolerability with aripiprazole.   "
232209|NCT00892073|"     To study the effect of combined diazoxide-metformin therapy on body weight in youth with     hypothalamic obesity following treatment for craniopharyngioma. A secondary objective is to     evaluate changes in insulin resistance (IR), beta-cell function, features of the metabolic     syndrome, muscle metabolism and intramyocellular lipid.      Hypothesis: Treatment with diazoxide and metformin will result in weight loss or slowed     weight gain and improved metabolic profile, compared to pretreatment levels.   "
232210|NCT00892086|"     The purpose of this study is to collect the prevalence of geriatric syndrome, which is     recognized by an internist, and to compare the data based on the comprehensive geriatric     assessment by a geriatrician. The secondary outcome is to develop a practical collected form     for the internist.   "
232211|NCT00892099|"     Infection is the second-leading cause of death in individuals requiring dialysis treatment     for kidney failure. New research suggests the high risk of infection may be due in part to     low levels of vitamin D, which are extremely common in kidney disease. This study is designed     to determine safe and effective ways to raise vitamin D levels while monitoring effects on     the immune system.   "
232214|NCT00892138|"     This study will assess the short and long term effects of a group-based mindfulness programme     (Mindfulness-Based Stress Reduction, MBSR) on first year medical and psychology students at     the Universities of Oslo and Tromso.      The primary outcome variables are mental distress, student stress and subsequent work stress,     subjective wellbeing, empathy, mindfulness and spirituality. The investigators will also     study explanatory moderator and mediator variables.      The study will be a two-centre randomized controlled study involving 288 medical and     psychology students from the University of Oslo and from the University of Tromso. The sample     size calculation is based on a reduction in mental distress and perceived medical/psychology     school stress of 20% in the intervention group. The control group will not receive an     intervention. After the initial seven week course (taking place in 2009 and 2010) the     intervention group will receive a follow-up session of 1.5 hours twice a year throughout     their study course of 5-6 years. The follow-up period will last until 1 year after graduation     in the Oslo cohort and until 3 years after graduation in the Tromso cohort.   "
232215|NCT00892151|"     The purpose of this study is to evaluate a Diabetes management program in the hands of     potential users, both health care professionals and lay persons.   "
232216|NCT00892164|"     The objective of this study is to compare the results of total thyroidectomy using the new     harmonic scalpel device to that with the electrothermal bipolar vessel sealer.   "
232217|NCT00892177|"     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also     block the growth of the tumor by blocking blood flow to the tumor. It is not yet known     whether bevacizumab together with dasatinib are more effective than a placebo in treating     patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.      PURPOSE: This randomized phase I/II trial (Phase I completed) is studying the side effects     and best dose of dasatinib when given together with bevacizumab and to see how well it works     compared to placebo in treating patients with recurrent or progressive high-grade glioma or     glioblastoma multiforme.   "
232218|NCT00892190|"     This is an open label, prospective, single institution dose-escalation study. The patient     population includes non-induction candidate elderly patients with AML or MDS and/or patients     with high-risk or relapsed/refractory AML or MDS. Five dose cohorts will be evaluated using a     fixed dose of ATRA in combination with an escalating dose of dasatinib. The investigators     will treat with an escalating dose of dasatinib from 70mg to 140mg daily. Dose escalation     will proceed in a standard 3+3 fashion. A de-escalation to a 50 mg total daily dose of     dasatinib is planned if DLT is greater than or equal to 33% is observed at the first dose     level. Once the MTD for the combination of the drugs has been established, up to 6 additional     patients will be enrolled at the MTD level to obtain additional safety information about the     combination and to allow for preliminary laboratory correlate analysis.   "
232219|NCT00892203|"     This study will assess the efficacy and safety of BGG492 used to treat migraine pain.   "
232224|NCT00892268|"     RATIONALE: Acupuncture may reduce joint pain in postmenopausal women with breast cancer. It     is not yet known whether acupuncture is more effective than standard therapy analgesics in     decreasing joint pain caused by aromatase inhibitors.      PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works     compared with medication in reducing pain in postmenopausal women with breast cancer and     joint pain.   "
232225|NCT00892281|"     The objective of this study is to assess the effectiveness, safety, subject satisfaction and     quality of life with Oracea® when used as monotherapy or as add-on therapy to existing     topical regimens for the treatment of rosacea.   "
232226|NCT00892307|"     Researchers hope that this new non-invasive multi-detector scanner (DSCT) will provide     diagnostic information comparable to the combination of traditional SPECT (for function and     blood flow) and CT imaging (for a precise anatomical view).   "
232227|NCT00892320|"     The purposes of this study are to evaluate the effect of food on the pharmacokinetics of     extended-release (ER) OROS paliperidone in healthy Japanese adults and to assess the safety     and tolerability.   "
232228|NCT00892333|"     The rate of hernia recurrence at one year following repair of a large abdominal hernia with a     biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of     40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year     following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being     that such rate will be less than 20% at one year, representing a 50% reduction over the     historic rate of 40%.   "
232229|NCT00892346|"     The clinical trial is to evaluate the efficacy of single autologous hematopoietic stem cell     transplantation with standard conditioning of melphalan 200 mg/m2 followed by thalidomide     maintenance in patients with newly-diagnosed myeloma after receiving 4-6 cycles of induction     chemotherapy consisting of vincristin,adriamycin and dexamethasone (VAD) or     thalidomide/dexamethasone between 18 to 65 years.   "
232235|NCT00892424|"     Cancers that have spread to the liver from the primary cancer location (liver metastases)     that cannot be removed surgically (unresectable) can be treated with chemotherapy and/or     radiation therapy. Previous research has shown that tumours often have abnormal blood vessels     that may reduce the effect of radiation therapy. New drugs, known as anti-angiogenic drugs     have been shown in animal and human studies to damage or change tumour blood vessels in ways     that may make tumors more sensitive to radiation treatment. 32- 44 Patients diagnosed with     unresectable liver metastasis will be invited to take part in this study. The purpose of this     study is to investigate the use of a new anti-angiogenic drug called Sorafenib, in     combination radiation therapy and chemotherapy. The study will test how effective the new     treatment is, the side effects associated with the new treatment, and to help establish safe     dosages of the study medication.   "
232449|NCT00895856|"     Getting old is a process of transformation of the body that occurs along the vital cycle in a     universal and progressive way causing functional restrictions in the human being. The aim of     this work was to identify, analyze and quantify the limitations of the functional capacity of     the institutionalized elderly who are not provided with physiotherapic assistance.   "
232230|NCT00892359|"     The purpose of this trial is to study the pharmacokinetics of anidulafungin during continuous     venovenous hemofiltration.      Background: Anidulafungin is a cyclic lipopeptide antifungal agent of the echinocandin class.     Members of this class of antifungal agents are known to inhibit the synthesis of glucan     polymers in fungal cell walls. The spectrum of activity of anidulafungin includes Candida     (all species, including strains resistant to fluconazole), Aspergillus, and Pneumocystis.      In intensive care patients continuous venovenous haemodiafiltration (CVVHF) is a     well-established extracorporal renal replacement therapy with a high clearance rate.      Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHF     are rare. No data about anidulafungin in CVVHF are available although intensive care patients     are perfect candidates for anidulafungin treatment due to their high risk profile for     systemic fungal infections.      Study objective: The study is conducted to investigate the pharmacokinetics of anidulafungin     during CVVHF in critically ill patients.      Study design: open, 1 arm      Study population: 10 critically ill adult patients administered to the ICU with acute renal     failure and suspected or proven fungal infection.      Treatment/Dosage/Route: On the first day 200 mg of anidulafungin will be administered     intravenously over 3 hours (loading dose). The following days 100 mg of anidulafungin will be     administered intravenously over 1.5 hours.      Main outcome variables: The following pharmacokinetic parameters will be determined: area     under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination     fraction.      Methods: High pressure liquid chromatography (HPLC) will be used to determine anidulafungin     concentrations.   "
232231|NCT00892372|"     Control of body weight (BW) is important to prevent and manage type 2 diabetes. Regardless of     the close association, little is understood about the precise relationship between BW and     glycemic control, which might be of benefit for patients with type 2 diabetes. The     researchers investigated the correlation between changes in BW and glycemic control in     patients with type 2 diabetes treated with a diet therapy or pioglitazone.   "
232232|NCT00892385|"     RATIONALE: Drugs used in chemotherapy, such as methoxyamine and temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving methoxyamine together with temozolomide may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of methoxyamine when     given together with temozolomide in treating patients with advanced solid tumors.   "
232233|NCT00892398|"     Trabeculectomy with mitomycin C remains the standard surgery for glaucoma. This surgery     involves creating a door in the eye wall in order to improve fluid outflow and decrease     intraocular pressure. However, success rates range from 70% to 90% depending on the criteria     used and tend to decrease with time. The failure of the surgery is associated with     inflammation, new blood vessel formation and scarring which can cause closure of the door.     Molecules which inhibit new blood vessel formation such as inhibitors of vascular endothelial     growth factor have been used successfully to decrease scarring in animal eyes where little     doors were created and significantly improve survival. Furthermore, they have shown promise     when used during trabeculectomy. Ranibizumab, a vascular endothelial growth factor, has also     been used safely in intraocular surgery to treat other diseases which involve new blood     vessel formation such as macular degeneration and diabetes.      The investigators hypothesize that ranibizumab may decrease the failure rate of     trabeculectomy with mitomycin C by decreasing scarring.      The aim of the study is to evaluate the difference in failure rates and bleb morphology at     one year post-operatively in eyes having undergone sub-conjunctival injections of ranibizumab     in addition to primary trabeculectomy with mitomycin C compared to eyes having undergone     trabeculectomy with mitomycin C alone.   "
232246|NCT00892580|"     The subjects that meet the inclusion and exclusion criteria and consent to participate in     protocol 22003 will be offered participation in 22003A which will evaluate secreted protein     before and after treatment with STX209 and placebo to determine if they correlate with     effectiveness of treatment or susceptibility to treatment with STX209. These same subjects     will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection.     The investigators will study the DNA to determine if STX209 works better in people with     specific gene variations, or to find new gene variations that predict how well STX209 works.   "
232247|NCT00892593|"     The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to     a colonoscopy screening program will improve colon cancer detection rates.   "
232234|NCT00892411|"     Background. Patients with chronic low back pain display hyperexcitability of the central     nervous system (central hypersensitivity). Such hypersensitivity may occur in the acute phase     and represent a risk factor for the development of chronic pain.      Objective. To determine the prognostic value of central hypersensitivity for the development     of chronic low back pain.      Design. Prospective cohort study.      Setting. Primary care.      Patients. 140 individuals with acute low back pain and no history of chronic pain.      Outcomes. Primary prognostic variable will be the pain tolerance threshold at the second toe     (the pressure intensity at which a further increase in pressure is deemed intolerable).     Exploratory secondary prognostic variables are measures of mechanisms related to central     hypersensitivity: stimulus-specific hypersensitivity (pressure, electrical, heat and cold     stimulation); tissue-specific hypersensitivity (skin vs. muscle stimulation); localized vs.     widespread hypersensitivity; spinal cord modulation (electrophysiological measures of     hypersensitivity and changes in receptive fields); modulation at brain level (descending     modulation of nociceptive input and cortical plasticity). Clinical primary outcome will be     the occurrence of chronic low back pain at follow-up.      Main analysis. The investigators will use least square logistic regression models to     determine the association of central hypersensitivity with prognosis.      Relevance. An understanding of the prognostic value of central hypersensitivity may allow an     early stratification for treatment of individuals at risk of developing chronic low back     pain. Subgroups of patients may be selected for clinical trials on novel pharmacological     approaches for the prevention and treatment of central hypersensitivity.   "
232450|NCT00895869|"     Retinopathy of prematurity screening is painful. Wide field digital retinal imaging (WFDRI)     and binocular indirect ophthalmoscopy (BIO) are being used for screening examinations. The     aim of Edinburgh, UK based study is to compare the pain experienced by infants using both     examination techniques.   "
232236|NCT00892437|"     The objective of this study is to evaluate the safety and efficacy of a regimen containing     cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate     (Truvada®; FTC/TDF) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1     infected, antiretroviral treatment-naive adults.      Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA     level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants     will continue to take their blinded study drug and attend visits every 12 weeks until     treatment assignments are unblinded, at which point all participants will return for an     unblinding visit and be given the option to participate in an open-label rollover extension     and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until     Gilead Sciences elects to terminate the study.   "
232237|NCT00892450|"     The purpose of this research study is to investigate the cognitive (thinking, memory,     knowledge, intelligence) side effects of two medications commonly used to treat overactive     bladder (OAB) symptoms in veteran patients with Parkinson's disease (PD) seen at the     Philadelphia PADRECC.   "
232238|NCT00892463|"     The proposed study is for a 6 week open-label clinical trial in which Seroquel XR is added to     a selective serotonin reuptake inhibitor (SSRI) medication for the treatment of depressive     and/or anxiety symptoms. Each subject will self-report changes in symptoms, functional     impairment, etc. on a twice daily basis using a handheld computer (HHC) that transmits     real-time symptoms reports to a central database. Each subject will be assessed in-person on     a weekly or biweekly basis during the course of the study.   "
232239|NCT00892476|"     The purpose of this study is to determine if supplementation of calcium by the enteral route     (gut feeding) to extremely low birth weight infants will lead to less myopia     (nearsightedness) at 6-12 months postnatal age.      Secondly, the study will determine if calcium supplementation is well tolerated, if it     reduces the molding of these premature infants' heads, and if it decreases myopia at the     18-22 month postnatal age visit.   "
232240|NCT00892489|"     The purpose of this study is to evaluate the bioequivalence between the Phase 3 and the     to-be-marketed formulations of extended release (ER) OROS paliperidone and to evaluate the     effect of food on the highest to be marketed tablet strength. Additionally, the safety and     tolerability of the treatments in healthy volunteers will be assessed.   "
232241|NCT00892502|"     The purpose of this study is to determine whether treatment with Bismuth can reduce the     toxicity of chemotherapy and radiotherapy in patients with malignant diseases of the blood.   "
232242|NCT00892515|"     RATIONALE: Exercise may change the risk of developing breast cancer. It is not yet known     whether low-intensity exercise or high-intensity exercise is more effective in lowering the     risk of breast cancer.      PURPOSE: This randomized clinical trial is studying how well exercise programs work in     healthy young women at increased risk of developing breast cancer.   "
232243|NCT00892541|"     The purpose of this study is to evaluate the effects of an organic cation transporter     inhibitor, trimethoprim, on the pharmacokinetics of orally administered ER OROS paliperidone     and to assess the safety and tolerability of the treatments in healthy male volunteers.   "
232244|NCT00892554|"     The purpose of this study is to determine if taking supplemental DHA improves measures of     processing speed and executive function in teen and adult women with PKU.   "
232245|NCT00892567|"     The purpose of this study is to evaluate T cell responses against a peptide-based vaccine in     patients with breast cancer and to determine whether peptide-specific T cells can be found at     the site of breast tumors following vaccination.   "
232248|NCT00892606|"     The investigators propose to compare analgesia by methadone and ketamine with a combination     of morphine and ketamine in orthopedic surgery patients with moderate to severe pain. The     investigators hypothesize that when given with ketamine before surgical incision, methadone     is more effective than morphine in reducing postoperative morphine consumption and reducing     pain during movement.   "
232249|NCT00892619|"     Epiretinal membranes (ERM) are cellular membranes on the surface of the retina that result in     distortion of the vision (metamorphopsia), and decreased best-corrected visual acuity. They     are most frequently found in patients over the age of 50 and have a reported prevalence of     7-12%. [1,2] Epiretinal membranes are caused by posterior vitreous separation, retinal     detachment, proliferative vitreoretinopathy, cataract surgery, trauma, inflammation, retinal     vascular disease, and idiopathic. [1-4] Epiretinal membrane removal by pars plana vitrectomy     combined with internal limiting membrane peeling leads to improved vision, decreased     metamorphopsia, and improved quality of life after surgery. [2] Internal limiting membrane     (ILM) peel has been associated with decreased rates of epiretinal membrane recurrence and is     also performed during vitrectomy for repair of macular holes or vitreomacular traction. [5,6]     Internal limiting membrane peeling can be performed by using an instrument to make a break in     the membrane followed by peeling with forceps, or by utilizing ILM forceps alone to pinch and     peel an unviolated ILM. No study exists comparing different intraoperative techniques used     for ILM peeling on visual outcomes and operating time. The investigators hypothesize that     using a pinch and peel technique will equal outcomes with shorter operating time than other     techniques.        1. McDonald HR, Johnson RN, Ai E, Jumper JM, Fu AD. Macular epiretinal membranes. Retina,          4th edition, editor Ryan SJ, Wilkinson CP, 2006, p 2509-2525.        2. Ghazi-Nouri SM, Tranos PG, Rubin GS, Adams ZC, Charteris DG. Vitrectomy and epiretinal          membrane peel surgery visual function and quality of life following. 2006;90;559-562;          Br. J. Ophthalmol        3. Haritoglu C, Gandorfer A, Gass CA, Schaumberger M, Ulbig MW, Kampik A. The Effect of          Indocyanine-Green on Functional Outcome of Macular Pucker Surgery. AM. J. Ophthal. VOL.          135,NO.3, 328-337, Mar 2003        4. Hiscott PS, Grierson I, McLeod D. Retinal pigment epithelial cells in epiretinal          membranes: an immunohistochemical study. Br. J. Ophthalmol, 1984, 68, 708-715        5. Park DW, Dugel PU, Garda J, Sipperley JO, Thach A, Sneed SR, Blaisdell J. Macular Pucker          Removal with and without Internal Limiting Membrane Peeling: Pilot Study. Ophthalmology          Volume 110, 1, Jan 2003        6. Kwok AK, Lai TY, Yuen KS. Epiretinal membrane surgery with or without internal limiting          membrane peeling. Clinical and Experimental Ophthalmology, 2005, 33:379-385   "
232250|NCT00892632|"     The investigators hypothesize that the confocal endomicroscopy imaging of the biliary     strictures during ERCP will differentiate between benign and malignant strictures in vivo and     has increased sensitivity compared to biliary brushing/biopsy, and that direct     cholangioscopic guidance of pCLE is more accurate than fluoroscopic guidance.   "
232280|NCT00893048|"     The prevalence of cellulitis in society is very high, as much as 3% of visits to Emergency     Departments are for the treatment of this disease. The treatment of cellulitis varies     depending on the severity. Low severity cases are treated with pain control and antibiotics     by mouth and high severity are treated with antibiotics intravenously and pain control. The     investigator's hypothesis is to see if the addition of steroids, which are known to decrease     inflammation, will decrease the length of the disease process. If so, it will decrease the     length of stay if IV antibiotics are needed, it will decrease duration of days out of work     and decrease the overall pain control required and therefore patient satisfaction.   "
232251|NCT00892658|"     Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide. The incidence is     highest in Asia and it is increasing in North America, with a two to three fold increase in     mortality in North America expected over the next two decades. Previous research has shown     that tumours often have abnormal blood vessels that may reduce the effect of radiation     therapy. New drugs, known as anti-angiogenic drugs have been shown in animal and human     studies to damage or change tumour blood vessels in ways that may make tumors more sensitive     to radiation treatment. 38-44 patients diagnosed with HCC will be invited to take part in     this study. Upon completion, this study will establish the safety of the combination of     radiation and sorafenib in patients with HCC. This will also establish preliminary data     regarding efficacy of the combination and investigate potential imaging and serum/tissue     markers surrogates for tumor response and/or drug activity.   "
232252|NCT00892671|"     This project involves a pre- and post- airway management and vascular access simulation     survey. The purpose of the study is to assess the perceived effectiveness of the simulation     course on the performance of medical students enrolling in the Anesthesiology rotation during     their third and fourth year of medical education.   "
232253|NCT00892684|"     The incidence of allergic diseases has increased and a relation between allergy and dietary     fatty acids has been proposed. Modulation of the maternal immune function during pregnancy     may have an impact on future clinical outcomes in the child. The aim of this study was to     determine the effects of omega (ω) - 3 long-chain polyunsaturated fatty acid (LCPUFA)     supplementation during pregnancy and lactation on the development of allergic disease (i.e.,     allergic eczema) in the child at 2 years of age. Pregnant women with allergic disease in     their immediate family were supplemented daily with 2.7 g ω-3 LCPUFA (n=70) or 2.8 g     soybean-oil as placebo (n=75) from gestational week (gw) 25 until the third month of     breastfeeding. Skin prick tests, detection of circulating specific IgE antibodies and     clinical examinations of the infants were performed at 3, 6, 12 and 24 months of age. The     mothers and children were monitored regarding immune modulatory effects during the entire     study period.   "
232254|NCT00892697|"     The purpose of this study is to determine the decline of virus in the blood and liver in     patients treated with telaprevir, pegylated interferon and ribavirin.      Fine Needle Aspiration (FNA) procedure will be used to repeatedly sample the liver to enhance     the understanding of how the virus decays in the liver in response to treatment with     anti-viral compounds and the measurement of the concentration of the drugs in the liver. FNA     is an alternative procedure to core needle biopsy in its ability to repeatedly sample the     liver with significantly reduced morbidity.   "
232255|NCT00892710|"     The purpose of this trial is to evaluate three treatment regimens in patients with stage     IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with a performance status of 2 and who were not     previously treated.   "
232256|NCT00892723|"     The purpose of this study was to determine the safety of AZX100 Drug Product and to determine     whether it was effective in preventing or reducing re-growth of surgically removed keloid     scars.   "
232257|NCT00892736|"     This phase I trial studies the side effects and best dose of veliparib in treating patients     with malignant solid tumors that do not respond to previous therapy. Veliparib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
232258|NCT00892749|"     This is a multi-center, open-labeled, non-comparative study to examine the safety and     efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia     patients on hemodialysis.   "
232259|NCT00892762|"     The purpose of this study is to understand differences in visual function-related     patient-reported outcomes between a non-BAK medication (Travoprost APS) and a BAK-preserved     medication (XALATAN®) in patients with open-angle glaucoma or ocular hypertension.   "
232260|NCT00892775|"     This study is undertaken to generate clinical data on GSK Biologicals' combined     measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from     newly established working seed viruses which are one passage further than the current working     seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current     working seed viruses will serve as comparator.      A seed lot system is a system according to which successive batches of a vaccine are derived     from the same master seed virus. For routine production, a working seed lot is prepared from     the master seed virus.   "
232293|NCT00893230|"     The aim of this study was to assess the clinical effect of Lactobacillus sakei     supplementation in children with atopic dermatitis.   "
232261|NCT00892788|"     This study will examine a contingency management (CM) intervention designed to provide     incentives for losing weight versus participating in a manual-guided behavioral weight loss     intervention alone. Participants in the CM condition will earn the opportunity to win prizes     by losing weight and completing activities that contribute to weight loss, such as keeping     daily food and physical activity diaries, choosing healthy foods, exercising, and using other     weight loss strategies. The investigators will determine if the CM improves weight loss     relative to the usual care manual-guided intervention alone.   "
232262|NCT00892801|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving everolimus together with whole-brain radiation     therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus and     to see how well it works when given together with whole-brain radiation therapy in treating     patients with brain metastasis from non-small cell lung cancer.   "
232263|NCT00892814|"     The purpose of this trial is to investigate the difference in late radiation morbidity     between partial breast irradiation and whole breast irradiation given to women operated on     with breast conservation surgery for early breast cancer with a low risk of local recurrence.   "
232298|NCT00893295|"     RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to     treat. Finding out what affects a patient's decision to undergo screening tests may help     increase the number of patients who undergo regular screening for cancer. It is not yet known     whether personalized invitations to undergo colorectal cancer screening are more effective     than standard screening reminders.      PURPOSE: This randomized phase III trial is studying ways to increase colorectal cancer     screening in African Americans.   "
232264|NCT00892827|"     Chronic lymphocytic leukemia (CLL), an indolent disease of mature-looking B lymphocytes, is     the most common leukemia in Israel and the Western world. The disease is associated with     considerable morbidity and mortality, and is currently incurable. Rituximab (Mabthera) is a     chimeric monoclonal antibody directed against CD20 antigen, present exclusively on B     lymphocytes. Treatment with Rituximab is widely used in indolent B cell malignancies.     However, the administration of Rituximab in CLL patients yields less successful results than     in other indolent B cell malignancies, and even responding patients may become refractory. We     hypothesized that the abnormalities in the complement system identified in CLL underlie the     suboptimal response to Rituximab, since complement-dependent cell cytotoxicity is a major     mechanism of Rituximab action. Following patient consent and Institutional Review Board     approval, standard-dose Rituximab (375 mg/m2) will be administered, preceded by 2 units of     FFP. This treatment will be repeated every 1-2 weeks for 4-6 cycles. The clinical and     laboratory parameters, as well as adverse drug events, will be monitored.   "
232265|NCT00892840|"     The purpose of this study is to determine the safety and tolerability of BMS-820836 after     multiple doses   "
232266|NCT00892853|"     The purpose of this study is to determine if there is a link between calcium build up in the     veins or arteries (including the veins/arteries of the heart) and deterioration of the bone.     This will help understand if there is a connection between heart disease and bone disease.   "
232268|NCT00892879|"     This is a single-institution, prospective, one-to-one randomized controlled research study.     Subjects medically determined to need a cholecystectomy will be consented for surgery and     study participation prior to enrolment in this study. Patients will then be randomized to     receive either a single port laparoscopic cholecystectomy or a four port laparoscopic     cholecystectomy.   "
232269|NCT00892892|"     The primary purpose is to assess the role of sympathetic activation for the development and     progression of chronic renal failure. Using microneurography sympathetic activity will be     registered in various stages of kidney affection or failure and hypertension.      A sympatholytic agent will be compared with a non-sympatholytic drug to asses the effect     sympathetic activation and on the progression of kidney disease.      The effects of a sympatholytic agent on cardiovascular reactivity to various stressors wil be     examined.   "
232270|NCT00892905|"     The purpose of this study is determine the agreement of point of care (POC) clotting tests     (INR and aPTT) by the POC device by Hemochron Jr versus standard laboratory clotting tests     (INR and aPTT) in patients undergoing elective cardiac surgery.   "
232271|NCT00892918|"     The purpose of this study is to determine whether there is a difference in corneal epithelial     healing rate and/or toxicity following pterygium excision, between eyes treated     post-operatively by moxifloxacin(VIGAMOX)versus gatifloxacin (ZYMAR).   "
232272|NCT00892931|"     The purpose of this study is to determine the safety and effectiveness of Azixa in patients     with recurrent glioblastoma multiforme   "
232273|NCT00892944|"     The purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain.     This will then help to make accurate predictions of efficacy and dosing in the future     development programme.   "
232274|NCT00892957|"     The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS)     versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft     placement.   "
232275|NCT00892970|"     The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic     solution, 1% versus placebo over a two-week treatment period.   "
232276|NCT00892983|"     Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the     first year of life tends to lead to overweight in children, which in turn leads to overweight     in adults. This rapid early weight gain occurs most often at weaning when eating patterns     emerge. Infant sleep problems also appear to be associated with the risk of becoming     overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm     randomised controlled trial to determine whether extra education and support for families     around weaning and development of early food and activity habits, with or without     intervention to improve infant sleep, will decrease the current risk patterns of rapid     excessive early childhood weight gain in New Zealand. This would provide strong evidence for     the value of such a strategy in the long term control of the obesity epidemic and its     consequent complications.   "
232294|NCT00893243|"     Primary Purpose:        -  To compare the efficacy in treating dry eye syndrome in contact lens wearers or computer          users of Tears Again® versus Opticol® versus Optive®      Secondary Purpose:        -  Subjective evaluation of symptomatology        -  Evaluation of preference in different kind of administration - spray versus monodoses          versus multi-doses   "
232277|NCT00892996|"     Post-operative nausea and vomiting are the major complications after spinal anesthesia with     intrathecal morphine, therefore antiemetic drugs should be administered for best satisfaction     of anesthesia to prevent these complication.      Furthermore, administration of a combination of antiemetic drugs with different mechanisms of     action appears reasonable and synergistic effect of drugs.      In conclusion, we study efficacy of antiemetic effect of single antiemetic drug compare with     combination antiemetic drugs.   "
232278|NCT00893009|"     Chronic obstructive pulmonary disease (COPD) is a chronic progressive respiratory disorder     causing disability with an increasing burden to the patient, his family and to the health     services. Treatment of COPD patients depends on the stage of the disease. COPD responds     poorly to corticosteroids, in spite of inflammation is a major component in its pathogenesis.     A major barrier to therapy of COPD is resistance to the anti-inflammatory effects of     corticosteroids. The molecular mechanisms for this corticosteroid resistance are now being     elucidated, particularly as the molecular basis for the anti-inflammatory effects of     corticosteroids is better understood (12). An important mechanism of corticosteroid     resistance in COPD, which is also linked to amplification of the inflammatory process, is a     reduction in the critical nuclear enzyme histone deacetylase (HDAC)2 . Since the major     changes are at the level of small airways. We will examine the effect of addition of     theophylline product to stable COPD patients treated with combined inhaler of inhaled     corticosteroids.   "
232279|NCT00893035|"     The primary objective of this study is to evaluate the prediction of late toxicity by the     radiation induced CD8 T-lymphocyte apoptosis   "
232281|NCT00893061|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Aromatase inhibitors, such     as letrozole, anastrozole, and exemestane, may fight breast cancer by lowering the amount of     estrogen the body makes. Hormone therapy, using tamoxifen citrate, may fight breast cancer by     blocking the use of estrogen by the tumor cells. It is not yet known whether aromatase     inhibitors or tamoxifen citrate have less effect on memory in patients receiving treatment     for breast cancer.      PURPOSE: This randomized phase III trial is studying letrozole, anastrozole, or exemestane to     see how they effect memory compared with tamoxifen citrate in treating postmenopausal women     with breast cancer.   "
232282|NCT00893074|"     A subset of heavy marijuana users have trouble quitting marijuana use and the number of those     seeking treatment for problems related to marijuana is increasing. The purpose of this     research study is to investigate whether dronabinol can reduce withdrawal effects associated     with stopping marijuana use, if dronabinol can reduce the rewarding effects of smoked     marijuana, and whether there are any cognitive performance deficits associated with     dronabinol doses that produce such effects.   "
232283|NCT00893087|"     The purpose of this study is to study whether neurally adjusted ventilatory assist (NAVA)     provides advantages over current methods in detecting patients own breathing efforts in     pediatric and neonatal ventilatory care.      Our study hypothesis is that NAVA-technology is more accurate than currently used methods in     detecting and assisting spontaneous breathing in children, and thus the patient-ventilator     synchrony will improve.   "
232284|NCT00893100|"     The purpose of this study is to evaluate the effectiveness of diltiazem ointment 2 percent in     reducing pain after hemorrhoidectomy.   "
232285|NCT00893113|"     The purpose of this study is to assess the effect of Alfuzosin in treating Erectile     Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline     in erectile function (EF) domain of International Index of Erectile Function (IIEF).   "
232286|NCT00893126|"     The purpose of this study is to compare the prevalence and severity of CAD (coronary artery     disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular     risk factors.   "
232287|NCT00893139|"     The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective     for treatment of signs and symptoms of dry eye.   "
232288|NCT00893152|"     Post-traumatic stress disorder (PTSD), prevalent among returning OEF/OIF/OND Veterans, has a     powerful impact on family functioning. Good family relationships appear to moderate its     impact; stressful relationships may reduce the benefits of treatment. A program that assists     both Veteran and family in coping with the Veteran's PTSD could directly improve the     Veteran's re-adjustment and well-being and indirectly improve his/her social and occupational     functioning.   "
232289|NCT00893165|"     The purpose of this study is to observe a potential benefit of moderate physical activity by     using bed mounted cycles during hemodialysis treatment sessions on inflammatory markers in     the blood of patients with end-stage renal disease (ESRD).   "
232290|NCT00893178|"     Pulmonary Hypertension (PH) is a disease that is characterized by vasoconstriction of small     vessels of the lung. Many cases do have proliferation of endothelial cells within these     vessels. A possible influence of polymorphisms of genes relevant for inflammatory and     endothelial processes is suspected.      Especially patients with chronic heart failure can develope PH. The reasons therefore are     lacking.      The researchers investigate different polymorphism and the influence of these on pulmonary     artery pressure (measured invasively) in patients with congestive heart failure (CHF) and     patients with primary pulmonary hypertension.   "
232291|NCT00893191|"     Sildenafil has been shown to aggravate sleep-disordered breathing in patients with severe     obstructive sleep apnea. The aim of the present study is to examine the frequency of     sleep-disordered breathing in obese patients who are candidates for treatment with sildenafil     for sexual dysfunction. In addition we wish to assess the effect of sildenafil on     sleep-disordered breathing.   "
232292|NCT00893217|"     The purpose of this study is to valuate safety and tolerability of Betaseron.   "
232295|NCT00893256|"     Negative symptoms in schizophrenia present a challenge to the clinician owing to their poorer     response to conventional treatment with antipsychotics. Negative symptoms in schizophrenia     may be secondary to psychotic symptoms, depressive symptoms, drug-related side effects or     lack of environmental stimulation. Alternately, they may represent core features of the     illness, characterized as primary deficit symptoms. Previous studies have suggested that     atypical antipsychotics may be beneficial in improving deficit symptoms of schizophrenia.     This study aimed at characterizing the nature of improvement of negative symptoms in the     early phase (12 weeks) of treatment with the atypical antipsychotic, risperidone. In order to     account for factors contributing to improvement in secondary negative symptoms, ratings were     carried out of change in positive symptoms, depressive symptoms and drug-related side     effects. Further, add-on citalopram or placebo were administered in a double-blind design to     study the effect of selective serotonin reuptake inhibitor (SSRI) augmentation of risperidone     on negative symptoms. The investigators hypothesized that the improvement in negative     symptoms during the initial phase (12 weeks) of treatment with risperidone will be largely     accounted for by improvement in secondary negative symptoms, rather than of the primary     deficit symptoms.   "
232296|NCT00893269|"     Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this     has not been carefully studied. This research is being done to learn more about sleep     function in heavy marijuana users, and to determine whether a medication approved for     treating insomnia can help restore normal sleep function during brief periods of abstinence.   "
232297|NCT00893282|"     The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is     intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.     It is a water soluble polymer with reverse thermosensitive properties; the polymer exists as     a liquid at low temperature (below 17 C) and rapidly transitions to a high viscosity gel at     body temperature (i.e. in the ureter). BackStop is injected above the stones in the ureter     and is intended to prevent retrograde migration of stones during ureteroscopic lithotripsy.     Upon completion of the lithotripsy procedure, BackStop dissolves naturally or by irrigation.      The study hypothesis is that a greater proportion of patients will experience no retropulsion     of a kidney stone when BackStop is used versus no anti-retropulsion device when undergoing     intracorporeal lithotripsy.   "
232301|NCT00893334|"     The purpose of this study is to understand the biochemistry of different types of Limb-Girdle     Muscular Dystrophy (LGMD) and to determine appropriate outcome measures for future clinical     treatment trials for LGMD. It is being conducted at two sites in the Cooperative     International Neuromuscular Research Group (CINRG). It involves a one day clinical evaluation     at a participating institution that will take approximately four to six hours, and will     involve strength testing and muscle functional testing by a physical therapist, an evaluation     by a physician, pulmonary function testing, a complete cardiac evaluation with     electrocardiogram (ECG or EKG) and echocardiogram (Echo), and involve two blood draws, one     before the evaluation and one after the evaluation is complete. During the visit, the     participant will be asked to fill out a couple of questionnaires asking questions about     quality of life and activity limitations, as well as his/her understanding of their diagnosis     with regards to etiology (or cause of their muscle disorder), genetics, and inheritance of     their muscle disorder.   "
232302|NCT00893347|"     This study investigates how well a new therapy program prevents persistent symptoms (e.g.,     headaches, fatigue, irritability, etc.) after concussion. The program involves examining     beliefs about concussion and learning healthy coping strategies, and is completed with the     first three months post-injury.   "
232303|NCT00893360|"     The purpose of this study is to determine whether giving cardiosphere-derived stem cells     (CDCs) to patients with decreased heart function and/or a large amount of damaged muscle     after a heart attack is safe. CDCs are cells grown from small biopsy samples taken from the     heart. Giving a patient their own CDCs is an investigational procedure that has been approved     by the Food and Drug Administration for this study. In addition to determining whether this     treatment is safe, the study will also examine whether it can decrease the amount of heart     muscle damage and/or improve heart function after a heart attack. The amount of heart muscle     damage and the function of the heart directly affects prognosis (the predicted course of the     disease), and the development of heart failure and other complications some patients     experience after a heart attack.      By way of background, scientists and physicians believed, until just a few years ago, that     heart muscle damaged after a heart attack could not be replaced. Recently, however,     scientists discovered that new heart muscle can form, or be regenerated, and that this     process can be enhanced (or increased) by the administration of large numbers of certain     cells isolated from the heart or bone marrow. These cells can be stem cells, or cells derived     from stem cells, and they may achieve their benefit by forming new heart muscle cells,     becoming heart muscle cells themselves, or releasing substances which increase the ability of     already existing stem cells to form new heart muscle. All of the studies conducted so far     have been experimental and no cell type is approved for routine clinical care of patients     with heart disease. However, studies involving bone marrow stem cells do indicate some small     improvement in heart function and one large study demonstrated a decrease in clinical events     in the group which received bone marrow cells.      Investigators of this study decided to study CDCs because they come from a person's own body,     and therefore have no foreign immune antigens which may be rejected. Since the cells come     from the person's heart, they are more likely to form heart tissue. In addition, animal     studies indicate no safety problems and that these cells are capable of forming heart muscle     and blood vessel cells after heart attacks. The investigators are now studying whether the     same is true in humans.   "
232304|NCT00893373|"     Sorafenib is a multikinase inhibitor which is acting on various cellular pathways involved in     the genesis of acute myeloid leukemia (AML). Sorafenib is therefore a promising candidate for     improvement of chemotherapy results in AML. This clinical trial evaluates the efficacy of     sorafenib added to standard chemotherapy for AML in patients between 18 and 60 years of age.     Patients are randomised to receive either sorafenib capsules or placebo in addition to their     chemotherapy. The placebo and the sorafenib group will be compared regarding event-free     survival and other clinical outcomes. An event is either treatment failure or relapse or     death. According to the study hypothesis, the sorafenib group will have less events than the     placebo group.   "
232305|NCT00893386|"     The purpose of this study is to characterize the removability of the Attain StarFix® Model     4195 Left Ventricular (LV) Lead (StarFix®). The goal of the trial is to evaluate the lead     removal success in patients that are indicated for left ventricular lead removal. This study     is required by the Food and Drug Administration (FDA) as a condition of approval for the     Attain StarFix® Model 4195 LV Lead.   "
232306|NCT00893399|"     Randomized Phase-III, two-arm, open-label, multi-center study in adult patients with AML and     NPM1 mutation.      Before Amendment No. 4 (December 2013):      Primary Efficacy Objective:        -  Evaluation of efficacy based on event-free survival (EFS) after induction and          consolidation chemotherapy plus all-trans retinoic acid (ATRA) with or without          gemtuzumab ozogamicin (GO) in adult patients with acute myeloid leukemia (AML) and          mutant nucleophosmin-1 (NPM1)      After Amendment No. 4 (December 2013):      Primary Efficacy Objective:        -  Evaluation of efficacy based on overall survival (OS) after induction and consolidation          chemotherapy plus all-trans retinoic acid (ATRA) with or without gemtuzumab ozogamicin          (GO) in adult patients with acute myeloid leukemia (AML) and mutant nucleophosmin-1          (NPM1)   "
232307|NCT00893412|"     This study evaluates the analgetic effects of the fast-release orodispersible tramadol     tablet.      Tramadol acts through a weak affinity for μ receptors and secondly by inhibiting     noradrenaline and serotonin neuronal reuptake. It has been used since the 1970s by over 50     million people for the treatment of acute and chronic pain. The orodispersible Tramadol     tablet is a new galenic form and is available on the Belgian market for the last three years.     Pregastric absorption leads to a quicker onset of action.      So far, evidence shows that pain during and immediately after the Hysterosalpingography (HSG)     procedure is only significantly reduced by IV opioid analgesia. This study evaluates the     analgetic potential of an orodispersible opioid tablet. This tablet disintegrates rapidly (in     around 20-30 seconds) and may be taken without water. Its abuse potential is very low and its     respiratory depressant effect is negligible.   "
232319|NCT00893568|"     The post traumatic stress disorder PTSD arises when the physiological response to stress does     not come to its term. This study aims to explore the cognitive, psycho physiological and     cerebral mechanisms involved in PTSD, in fear conditioning and face matching tasks, before     and after treatment.PTSD patients will be recruited by Pr Jean-Claude Samuelian in his     service at the Conception Hospital and by Pr Jean-Michel Azorin in his service at the Sainte     Marguerite Hospital (Marseille) and will undergo either CBT or EMDR within those same     services. The tasks they will be asked to perform will study the psycho physiological,     cognitive and central mechanisms involved in PTSD and its treatment. All in all, 17 healthy     controls will be recruited as well as 17 PTSD patients for each of the two treatment group.In     terms of perspectives, this study would help isolate neural systems functionally involved in     PTSD and its treatment. A better knowledge of those mechanisms would set room for the     optimization of the current PTSD treatment.   "
232451|NCT00895882|"     This study will evaluate the safety, tolerability, and efficacy of vaniprevir when     administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat     treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.   "
232308|NCT00893425|"     In recent years, diabetic nephropathy, which may lead to dialysis treatment, is the most     prevalent underlying disease of people in developed countries. A wide range of studies have     been carried out, from various points of view, to understand the progress of renal     dysfunction in diabetic nephropathy. The endogenous nitric oxide synthase (NOS) inhibitor     asymmetric dimethylarginine (ADMA) is elevated in patients with chronic kidney disease (CKD)     and may have a role in the cardiovascular mortality and morbidity of these patients. In     diabetic nephropathy, high ADMA levels were related to progression of diabetic nephropathy.     The Fas (CD95) antigen is a cell surface polypeptide belonging to the tumor necrosis factor     receptor (TNF-R) family (type I membrane protein) that transduces a death signal after     interaction with its ligand. Apoptotic cells are then recognized and removed by phagocytes.     Recent studies suggest that, in uremic patients, peripheral blood mononuclear cells undergo     accelerated apoptosis and this correlates with Fas levels. There is no data about the effects     of Renin angiotensin system blockage (RAS) on CD95 and ADMA levels in diabetic patients with     proteinuria. The aim of this study was to find out whether the beneficial effects of RAS     blockage in diabetic proteinuria has any relation with the alteration of ADMA and CD95levels.     The investigators searched for the effects of ACE inhibitor ramipril on the clinical and     laboratory parameters of diabetic patients with proteinuria.   "
232309|NCT00893438|"     The aim of this study is to determine the efficacy of FITNET (web-based cognitive behavioural     treatment) for adolescents with Chronic Fatigue Syndrome (CFS) in The Netherlands. The second     goal of the study is to establish predictors of outcome. It is very important to know the     characteristics of patients who will benefit from Cognitive Behavioural Treatment (CBT) and     who will not. Possible predictors of outcome are: age, depression, anxiety, fatigue of the     mother, parental bonding, self-efficacy, body consciousness of child and mother, physical     activity (Actometer).   "
232310|NCT00893451|"     The purpose of this study is to evaluate the impact of vitamin D3 supplementation on the     insulin resistance in non-diabetic patients with chronic kidney disease (CKD) stages 3-4,     vitamin D deficiency/insufficiency and elevated fasting serum insulin levels.   "
232311|NCT00893464|"     This study is an open-label, multicenter, phase 1, dose-escalation study of IXAZOMIB in adult     patients with lymphoma. This study will be the first to administer IXAZOMIB to patients with     lymphoma.   "
232312|NCT00893477|"     RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different     ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.     Others find cancer cells and help kill them or carry cancer-killing substances to them.     Giving GM-CSF together with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab works     in treating patients with previously untreated follicular non-Hodgkin lymphoma.   "
232313|NCT00893490|"     This randomized, controlled trial (RCT) compares the efficacy and safety of Ahmed Glaucoma     Valve (AGV) implantation alone, with 3 minutes MMC application or with a single layer     coverage of amniotic membrane. Outcomes include intraocular eye pressure (IOP), postoperative     glaucoma medication and complications. AGV implantation site will be superior or inferior     based on indication and these groups will be randomized separately.   "
232328|NCT00893685|"     The DREAMING clinical trial is part of the DREAMING project, which has the objective to     demonstrate that the DREAMING platform consisting of integrated health monitoring, alarm     handling and videoconferencing services produces clinical benefits to its users and economic     benefits to the health authorities. The study evaluates the long-term (30 months) effect of     continuous use of the DREAMING subsystems and is testing the hypothesis that such use is     superior to usual care alone in reducing the deterioration of health related quality of life     that is associated to age and chronic disease. It also tests the hypothesis that the DREAMING     environment is superior to usual care in delaying the transfer to nursing or elderly homes     and in reducing the incidence and duration of hospitalisation episodes. The trial will also     evaluate the cost-effectiveness of the DREAMING platform. Outcomes are assessed in six     different health care systems (Denmark, Estonia, Germany, Italy, Spain and Sweden) and will     represent a basis for the adoption of DREAMING services by the respective health authorities.   "
235011|NCT00929708|"     The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks     treatment with AZD3199 in moderate to severe COPD.   "
232314|NCT00893503|"     Colorectal cancer is a major public health concern in Alberta. Colorectal Cancer is the     fourth most common diagnosed cancer and second overall in terms of cancer deaths in Canada.     One in 14 males and 1 in 16 females aged 50-74 will be diagnosed with colorectal cancer and     will have an overall 1 in 28 chance of dying from colorectal cancer. While colorectal cancer     is surgically curable if diagnosed in the early stages, with five year survival rates of 90%     versus 10% if detected at more advanced stages, less than 20 % of all individuals in this age     bracket traditionally have undergone colorectal cancer screening. Colorectal cancer often     presents with non-specific symptoms where non-cancerous polyps are commonly found. If these     polyps are left in place, they may grow over time and progress from a non-cancerous mass to     symptomatic cancerous tumors; therefore, early screening in those patients without symptoms     may thereby prevent the progression from a non-cancerous to cancerous finding.      The hypothesis, or theory being studied in the SCOPE Pilot research study, is that     implementation of a colorectal screening program would decrease colorectal cancer prevalence,     increase the long-term survival ratio for patients, and decrease burden on the health care     system. Moreover, early detection and treatment of colorectal cancer has the potential to     increase the lifespan of patients and decrease health care costs.      The SCOPE Pilot Research study will recruit 1000 individuals between the ages of 50 - 74 of     average to high risk for developing colorectal cancer as determined by their referring     Gastroenterologists. Those patients who are ages 40-50 will also be eligible if they have a     personal or family history of colorectal cancer. Patients referred to the SCOPE Pilot program     will be further screened for eligibility, and if no exclusion criterion is present, will be     invited to attend an education session and research program. The SCOPE Pilot research study     will compare the current fecal occult blood testing (FOBT - Hemoccult II) with newly     available FOBT blood testing along with colonoscopy therapy. It will also encompass     educational information, risk stratification, screening for both average and high risk     patients, and colonoscopy.   "
232315|NCT00893516|"     Evaluation of CD4 in combination with CHO chemotherapy in subjects with nodal involvement of     non cutaneous Tcell lymphoma.   "
232316|NCT00893529|"     Obesity results from an imbalance between energy intake and energy expenditure. There is much     speculation about foods that are particularly fattening, and sugary drinks are seen as major     culprits. It is hypothesized that a high intake of calories from sugary drinks would not be     compensated for by reduced food intake at subsequent meals. As a result, body weight would     increase. In this double-blind, long term, randomized controlled trial the effect of     replacing sugar-containing beverages by low-sugar alternatives on body weight and fat mass in     children will be investigated.   "
232317|NCT00893542|"     The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg     Capsules under fasted conditions.   "
232320|NCT00893581|"     Specific Aim 1: To determine the effects of treatment with quetiapine or lithium on brain     activation in adolescents. The investigators will use functional magnetic resonance imaging     (fMRI) to examine brain activation during an attentional task.      Specific Aim 2: To determine the effects of treatment with quetiapine or lithium on     neurometabolite measures, early in their illness course. The investigators will use 1H-MRS to     identify myo-inositol (mI), N-acetyl aspartate (NAA), and glutamate (Glu) levels in     prefrontal ALN regions.      Specific Aim 3: To determine the relationships among the changes in brain activation and     neurometabolite measures, as well as symptomatic improvement in manic adolescents.   "
232321|NCT00893594|"     This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn     in the treatment of migraine with aura.   "
232322|NCT00893607|"     Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when     administered as a slow release suppository applied to the anal canal or rectum. In addition,     the pharmacokinetics of NRL001 in plasma, adverse events, and any changes in heart rate or     blood pressure were to be assessed.   "
232323|NCT00893620|"     The Zenith(R) Connection Endovascular Covered Stent Clinical Study is a clinical     investigation to study the safety and performance of the Zenith(R) Connection Endovascular     Covered Stent in conjunction with the Zenith(R) Branch Endovascular Graft-Iliac Bifurcation     in the treatment of aorto-iliac and iliac aneurysms.   "
232324|NCT00893633|"     The aim of this research is to investigate critical illness neuromuscular abnormalities in     neurocritical care patients.   "
232325|NCT00893646|"     The study is a year-long health-behaviour intervention in obese, male truck-drivers to lose     weight moderately by 10%, using monthly individual counseling. The investigators hypothesize     that lifestyle modification (increased physical activity, changes in eating habits, and     improved schedule for sleep) through weight loss improves daytime alertness and quality of     sleep, reduces daytime sleepiness, and improves cardiovascular risk factors and     health-related fitness.   "
232326|NCT00893659|"     The aim of this study is to determine the effect of the potential prebiotic beta-glucan on     the intestinal microflora, the bacterial enzyme activity (beta-glucuronidase and     beta-glucosidase) in the feces, the fecal pH and the concentration of fecal short-chain fatty     acid in polypectomized patients. Also the in vitro anti-cyto- and anti-genotoxicity of fecal     water will be examined on human cell culture (HT29). During the trial, patient's clinical     symptoms (intestinal habits), physical activity, well-being and food intake will be recorded.   "
232327|NCT00893672|"     Current guidelines recommend Routine daily chest radiographs (CXRs) for mechanically     ventilated patients in intensive care units (ICUs). However, some ICUs have shifted to an     On-demand strategy, in which this CXR is only prescribed if warranted by the patient's status     at the morning physical examination. Here the investigators compared Routine and On-demand     strategies in 21 French ICUs. The working hypothesis was that CXR prescriptions would fall by     at least 20% with the On-demand strategy, with no reduction in quality of care.   "
232349|NCT00893958|"     The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg     tablets under fed conditions.   "
232329|NCT00893698|"     The aim of the study is to realize a bilateral transplantation of upper limbs. The first     objective is functional but there are aesthetic and psychologic imperatives too. This open     and descriptive study needs compatible donor and recipient. The sample should be realized     simultaneously and the transplantation should be made by two coordinated teams according to     this sequence : osteosynthesis, vascular anastomosis, sutures of tendons and nervous sutures.     An immunosuppressant treatment should be initialized from the beginning of the intervention     and continued for life. Rejections should be screened by regular clinical and histological     examinations.   "
232330|NCT00893711|"     The purpose of this study is:        -  to study the intestinal microflora of colicky infants before and after L. reuteri or          placebo administration, evaluating the effect of Lactobacillus reuteri on the growth of          the main intestinal microbiota (coliforms, Clostridium butyricum, Lactobacilli,          Bifidobacteria) with fluorescent in situ hybridization (FISH) technique or with          Real-Time PCR Taqman; Further, the global intestinal microflora composition, using          large-scale DNA sequencing of 16S rRNA genes ( 454-pyrosequencing technique.        -  to evaluate the improvement of colicky symptoms by the oral administration of          Lactobacillus reuteri (primary outcome: reduction of the daily average crying time from          baseline to the end of the treatment period, to less than 3 hours a day, the cut-off          proposed by Wessel; secondary outcome: number of responders versus non-responders in          each group at the end of the treatment).        -  to evaluate fecal calprotectin values at the beginning and at the end of the study.          BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland). A          quantitative immunoassay.        -  to evaluate Th17/Treg balance at time 0 and t 30 ( days) investigating mRNA FOXP3 and          RORγ in peripheral blood using RT-PCR Real Time Taqman.        -  Parental satisfaction at the end of the study period ( 30 day ) with a numerc scale from          1 to 10.   "
232331|NCT00893724|"     Nutritional supplements have an augmentative effect on the outcomes of standard treatment of     diabetic macular edema (DME) and Neovascular Age-Related Macular Degeneration (NAMD).   "
232332|NCT00893737|"     Many clinical trials may not fully explore criteria that are important to some migraine     patients' definition of complete response. This study offers the opportunity to evaluate     the effectiveness of Treximet™ when non-standard criteria are examined (for example, neck     pain, irritability or fatigue). Subjects enrolled at 8 investigative sites will complete 2     visits. Subjects will complete a Completeness of Response Survey at Visit 1 considering their     usual migraine medication (a triptan) and a Completeness of Response Survey at Visit 2     considering their study medication (Treximet™).   "
232342|NCT00893867|"     The purpose of this trial is to determine if intravenous administration of the metal ion     trapping agent DP-b99 up to 9 hours following acute ischemic stroke onset, and then for 3     additional days (4 consecutive days in total) is effective in improving long term outcome.     Patients will be followed up for 3 months after the stroke.   "
232343|NCT00893880|"     A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat     moderate to severe tinea pedis.   "
232344|NCT00893893|"     Purpose:      To investigate the uptake of VLDL-TG in visceral fat in lean and overweight individuals   "
232333|NCT00893750|"     More than 300,000 children are fighting in armed conflicts all over the world. In Uganda an     estimated number of 25,000 children have been abducted and forced to fight or work as porters     and sex slaves on the side of the rebels during the conflict between the Lord's Resistance     Army (LRA) and the Ugandan government. Each year, thousands of former child soldiers have     returned to their communities after they had fled or were freed from the rebels. It is well     known that a high percentage of these youths are suffering from mental health problems. This     could be one of the possible reasons why they are facing difficulties to reintegrate into     their communities.      The main aim of the proposed project is two-fold. On the one hand, the investigators want to     systematically explore the relationship between mental health and important variables for     reintegration into the communities like aggression, hostility, feelings of revenge,     compromises and conflict behaviour and readiness for reconciliation in formerly abducted and     other vulnerable youth (orphans, child mothers and handicapped youths) in Northern Uganda. On     the other hand, the investigators want to probe the efficacy of existing and newly developed     interventions for formerly abducted and other vulnerable youths that are supposed to foster     their mental well-being as well as their reintegration into the society and therewith are     part of the long-term prevention of new conflicts in Northern Uganda.   "
232334|NCT00893763|"     Ventilator-associated pneumonia (VAP) is a serious complication in mechanically ventilated     critically ill patients. The intervention tested in this project (swabbing the mouth with     chlorhexidine before the endotracheal tube is inserted) could reduce the risk of     ventilator-associated pneumonia.   "
232335|NCT00893776|"     A small, pilot study consisting of twelve participants with subacute (6-12 months     post-stroke)and chronic stroke (1year+ post-stroke)living in and around Columbia area. The     twelve participants will randomly be selected to participate in either unilateral     (one-handed) task training (6 participants) or bilateral (two-handed) task training (6     participants) with the SaeboFlex orthosis. Each group will undergo six assessments to     establish pre-testing baseline and qualification, followed by a training session, four-week     combined home and clinic program, and post-testing to determine changes in affected arm use     and function. The hypothesis is that two-handed training will before effective than     one-handed training.   "
232336|NCT00893789|"     The primary objective of the study is to determine whether armodafinil treatment is more     effective than placebo treatment in patients with excessive sleepiness associated with mild     or moderate closed traumatic brain injury (TBI).   "
232337|NCT00893802|"     The aim of this study is to evaluate the effects of treatment of periodontal disease during     the second trimester of gestation in adverse pregnancy outcomes.      Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health     Center will be divided into two groups: NIG- 'no intervention' or IG- 'intervention,'     according to agreement in receive periodontal treatment during pregnancy. Treatment will be     performed by a single periodontist consisting of scaling and root planning (SRP),     professional prophylaxis (PROPH) and oral hygiene instruction (OHI). Patients at NIG will     receive PROPH and OHI during pregnancy and will be referred for treatment after delivery.     Periodontal evaluation will be performed by a single trained examiner, blinded to periodontal     treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index     (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days     post-partum. Primary adverse pregnancy outcomes to be addressed are: preterm birth (< 37     weeks), low birth weight (< 2.500 Kg), late abortion (14-24 weeks) or abortion (< 14 weeks).     The results obtained will be statistically evaluated according to OR, unpaired t test and     paired t test.      It is expected that periodontal treatment during the second trimester of gestation will     result in decreased rates of adverse pregnancy outcomes.   "
232338|NCT00893815|"     Despite the advent of highly active antiretroviral therapy (HAART), the prevalence of     neurocognitive impairment among HIV-infected patients continues to be an important issue.     Although severe forms of AIDS-related dementia have diminished, milder forms of cognitive     impairment have been noted among approximately 30% of asymptomatic HIV patients. Studies     among HIV-infected U.S. military personnel regarding neurocognitive function have largely     been limited to the early 1990s, before the advent of HAART. In these studies subtle     neurobehavioral changes were noted among asymptomatic HIV-positive military personnel.      This study proposes to determine the prevalence of neurocognitive deficits among HIV-positive     military beneficiaries during the era of HAART who are participants of the U.S. Military HIV     Natural History Study. The prevalence ascertained in this study will be compared to     HIV-negative military beneficiaries who are demographically similar to the HIV positive     group. The sample size of the study is to have complete testing on 200 HIV positive and 50     HIV-negative participants; due to the possibility of attrition before study completion, the     investigators will enroll up to 300 participants (240 HIV-positive and 60 HIV-negative) to     achieve this sample size. The investigators' rates among HIV-positive patients found in this     study will also be contextualized in the setting of the prevalence of prior neurocognitive     deficits seen in a HIV positive U.S. military population studied in the 1990s, contemporary     rates among civilian HIV-infected persons, and normative values in the general HIV-negative     population. Compared to other data in the field of neuropsychology, this study is novel in     that the HIV population studied is composed largely of HIV patients who have been diagnosed     early in their HIV infection; have open, free access to antiretrovirals to begin therapy     earlier than most other cohorts; and consists of highly-functioning, educated individuals.   "
232339|NCT00893828|"     The PAPIRUS III study will continue to follow patients initially enrolled in PAPIRUS II.     Pressure readings from the investigational device will continue to be collected and will be     correlated to physiological changes during activities of daily living and protocol defined     tests.   "
232340|NCT00893841|"     This study is designed to assess the use of pramipexole dihydrochloride and quetiapine     (Seroquel) XR as combination therapy for bipolar depression. The proposed benefit of the     combination therapy investigated in this study is improved treatment of bipolar depression.   "
232341|NCT00893854|"     Cystoids macular edema (CME) is one of the most common causes of low vision due to uveitis.     The treatment for reducing the intra-ocular inflammation can decrease the macular edema. In     some patients, CME persists even after inflammation control, and additional treatment is     needed for better vision. Oral steroid, periocular and intravitreal Triamcinolone are the     principles in treatment, but some complications like cataracts and increased ocular pressure     have been seen. Diclophenac is a non-steroid anti-inflammatory drug that improves the vision     and decreases the macular thickness by slowing down the prostaglandin E2 (PGE2) ending in     vascular endothelial growth factor (VEGF) inhibition. In this study, the investigators are     going to compare the therapeutic affect of intravitreal Diclophenac and Triamcinolone in     persistent uveitic cystoids macular edema. Since diclophenac is a cheap and accessible drug     in all curative centers it could be applied instead of Triamcinolone.   "
232400|NCT00894491|"     Patient survey identifying key elements of patient experience and decision-making processes     regarding attendance University of California, Irvine (UCI)'s Integrative Medicine Clinic.   "
232345|NCT00893906|"     Influenza, a highly communicable acute respiratory disease, is one of the major infectious     disease threats to the human population. In Africa, information on the occurrence of     influenza and its disease burden is seriously lacking. Such data would be important in     determining the contribution of influenza to the more than two million annual pneumonia     deaths among children globally, mostly in the developing world, and the potential number of     deaths that could be prevented by influenza vaccination.      A single dose of trivalent inactivated influenza vaccine (TIV) is 70 to 90 percent effective     in preventing influenza in healthy older children and young and middle-aged adults, but is     less efficacious in young children and the elderly. Young children who suffer substantial     influenza morbidity and are unlikely to have pre-existing immunity should receive two doses     of TIV to provide adequate immunity. Because family studies of influenza transmission     conducted during the 1970's found children to be the main introducers of influenza into     households, vaccination of children may decrease the chances of spreading influenza to     contacts. Mass vaccination of schoolchildren has been correlated with reduced respiratory     illness in unvaccinated persons suggesting that immunization of children on a larger scale     can affect community epidemics.      In temperate industrialized countries with seasonal disease, influenza vaccine is given     annually, prior to the influenza season, and generally targeted to individuals with the     highest risk of severe disease. Influenza prevention strategies may need to differ in     tropical developing countries due to a variety of reasons. Given the varying influenza     circulation patterns, it is unknown which hemisphere vaccine formulation will provide     year-round protection against the diverse strains that may exist in tropical countries.     Persons residing in developing countries also may have nutritional deficiencies or underlying     diseases and infections that affect vaccine immunogenicity. Consideration must be given to     programmatic issues as well. Adolescent and adult preventive health services are poorly     developed in many countries, and thus a strategy that targets children may be the most     feasible option. In addition, vaccinating children may be the most cost-effective option, as     it has the potential to provide direct benefit to those vaccinated, as well as indirect     benefits to unvaccinated members of the population. Thus, an influenza vaccine effectiveness     study in a tropical developing country population will help to elucidate burden of seasonal     influenza and may inform optimal use of vaccine for either seasonal and pandemic situations.      Thus, this study in Senegal will to evaluate the direct effects of TIV in reducing the     occurrence of laboratory-confirmed influenza among children who receive it as well as the     potential indirect effects experienced by the population as a result of reducing transmission     among children.   "
232346|NCT00893919|"     The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg     Capsules under fed conditions.   "
232347|NCT00893932|"     Leptin is a hormone that plays a central role in food intake and energy balance. It is     secreted by fat cells, released into the circulation and transported into the central nervous     system (brain), where it regulates energy balance and food intake. The overall effects of     leptin appear to reduce food intake when the body is calorically satisfied, and to alter     metabolic rate A decrease in the amount of body fat, which occurs after fasting, reduces the     level of leptin, thereby stimulating food intake. Systemic Inflammation is a condition in     which body tissues respond to stress. It may be associated with severe infection or other     stimuli such as trauma, and may lead to organ failure and death. It has been shown, that     Leptin may be a survival protein, where higher levels are associated with lower mortality.     The investigators set out to quantify the levels of Leptin in critically ill patients in     association with other markers of inflammation and mortality.   "
232348|NCT00893945|"     This study involves cancer research and the purpose is to assess the safety and activity of a     type of vaccine as immune therapy for cancer.      This vaccine will be made from each participant's own immune cells (called dendritic cells)     obtained by blood donation. Dendritic cells (DCs) are immune cells whose role is to identify     foreign material in the body (such as bacteria, viruses, or tumor cells).      When DCs recognize this material, they use it to activate other cells of the immune system to     mount an attack against that foreign material. In the Laboratory of Molecular Neuro-Oncology,     each participant's DCs will be loaded with samples of their own tumor cells that were     obtained at surgical resection. These tumor cells are killed in the laboratory using a     special protocol, and then fed to the DCs. The DCs eat this material, and these fed DCs     make up the vaccine.   "
232351|NCT00893984|"     In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in     cardiovascular patients who are not able to tolerate conventional beta blockers. A side     effect profile will be tracked and compared with previous beta blocker use.      The investigators hypothesize that Bystolic will be tolerated by many patients who are     intolerant of conventional blockers.   "
232352|NCT00893997|"     Primary aim:        1. To determine the immunologic response, using a PR1-HLA-A2 tetramer assay, to 4          subcutaneous (SQ) injections of TVC-PR1 vaccine formulated in Montanide ISA 51 VG          followed by granulocyte macrophage colony-stimulating factor (GM-CSF) in low risk and          intermediate-1 myelodysplastic syndrome (MDS) patients.      Secondary aims:        1. To determine if non-immunologic responders to 4 subcutaneous (SQ) injections of TVCPR1          vaccine formulated in Montanide ISA 51 VG followed by GM-CSF can be converted to          immunologic responders by administering 4 additional doses of TVC-PR1 vaccine formulated          in Montanide ISA 51 VG followed by GM-CSF.        2. To determine the clinical response to 4 or 8 subcutaneous (SQ) injections of TVC-PR1          vaccine formulated in Montanide ISA 51 VG followed by GM-CSF in patients low risk and          intermediate-1 MDS.   "
232353|NCT00894010|"     The purpose of this study is to determine whether patients who usually have abnormal     electrical EEG responses when shown flashing lights will show a reduction in abnormal     electrical activity when they take a single dose of 2 marketed drugs (carbamazepine and     levetiracetam). If so, a similar study in the future may be able to identify promising new     drugs for epilepsy.      Patients who successfully complete the screening visit, will return 4 additional times and     will receive either placebo (2 times) or a single oral dose of both carbamazepine 400mg and     levetiracetam 1000mg in random order.      During each of the study days, several procedures and intermittent photosensitivity (IPS)     assessments will be performed at 5 pre-determined times over the course of the day, one     pre-dose and 4 post-dose.   "
232354|NCT00894023|"     Background: Percutaneous coronary intervention (PCI) is a highly effective therapy for acute     ST-elevation myocardial infarction (STEMI). Adjunctive therapy with glycoprotein (GP)     IIb/IIIa inhibitor can result in increased patency and improved outcomes in STEMI patients,     with thrombus, undergoing PCI. The investigation of novel dosing and delivery strategies of     this therapy may help to further improve outcomes.      Study design: Intracoronary Abciximab With Clearway Catheter trial is a randomized,     open-label, multicenter, trial to evaluate the effect of an intracoronary (IC) bolus dose of     abciximab delivered using the ClearWay™RX catheter versus an intravenous bolus (IV) of     abciximab for STEMI with angiographically visible thrombus (Thrombus Grade > 2). All patients     in both arms will receive intravenous abciximab infusion following the PCI for 12 hours per     standard practice. A total of 150 patients will be randomized 1:1 to treatment of the culprit     artery with IC abciximab (75 subjects) or IV abciximab (75 subjects) in addition to an     infusion regimen of abciximab administered intravenously and initiated following PCI. The     primary endpoint chosen to evaluate this hypothesis is infarct size as assessed on Cardiac     Magnetic Resonance (CMR). Clinical outcomes will be assessed for each subject through     hospital discharge and at 30 day follow-up.      Sample size: The number of patients included in this study was based on the estimation of the     sample size needed to identify a statistically significant difference of the primary     end-points between the two groups. The investigators estimated that 75 patients would be     required in each study group to have a power of 80% to detect an absolute difference in the     infarct size resolution of 15% with a two-sided alpha value of 0.05.      Conclusion: The purpose of this study is to demonstrate that an IC bolus of abciximab     delivered with the ClearWay™RX catheter added to a post-PCI intravenous infusion regimen of     abciximab will result in significant additional clot resolution in vivo when compared with an     IV bolus of abciximab when added to a post PCI intravenous infusion regimen of abciximab. The     primary endpoint chosen to evaluate this hypothesis is infarct size as assessed on CMR.   "
232355|NCT00894036|"     Objectives:      The aim of the study is to determine the molecular epidemiology and genetic variability of     ESBL-producing enterobacteriaceae (E-ESBL) among children in Switzerland and to estimate the     associated clinical burden of disease.      The investigators' hypotheses are:        1. The genetic variability (and especially the distribution of strains harbouring the CTX-M          genes) among children is similar to that observed in adults;        2. The overall burden of disease is still low in Switzerland compared to neighbouring          countries. However, treatment of severe E-ESBL infections is challenging;        3. The recommended oral treatment procedure with 3rd generation cephalosporins for febrile          urinary tract infection may contribute to increased prevalence of E-ESBL in the long          term.      The study is scheduled to start July 1st, 2008, and end June 30th, 2010.   "
232356|NCT00894049|"     This study is a prospective comparison between 2 popular regimens based on reduced intensity     or non-myeloablative approaches to define the optimal myeloablative and/or     immu-nonsuppressive association for reduced intensity conditionings (RIC).      Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2     days) and Thymoglobuline (2.5 mg/m²/1day).      Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation     (TBI).      A randomization of 2 phase study according to the methodology developed by Liu et al (Liu,     1993 and 2001) for the evaluation of multiple innovative approaches.      Primary endpoint is one year overall survival (OS). Stopping rules included excessive     engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an     independent safety review board (ISRB).      Inclusion criteria are patients presenting a hematological malignancy, eligible for non     myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable     HLA identical sibling. All patients and donors are included after giving written informed     consent.      Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular     therapies committee (national agency).   "
232357|NCT00894062|"     Stent thrombosis is an important issue in drug eluting stents. Incomplete endothelial     coverage and neointimal coverage over strut after drug eluting stent (DES) implantation could     be a possible cause of stent thrombosis. Therefore, theoretically dual antiplatelet therapy     should be continued to prevent the stent thrombosis until complete reendothelialization. But,     detection of endothelial coverage over stent is not possible with the available intravascular     devices in clinical practice. Among currently available intravascular devices, intravascular     optical coherence tomography (OCT) could give a more clear identification for a thin layer of     neointima with high-resolution (10-20 μm) compared to intravascular ultrasound (100-150 μm).     Previous OCT studies showed the significant different pattern of neointimal coverage between     bare metal stent (BMS) and DES. In the investigators' experience, there were also some     differences in neointimal coverage among the DESs, especially zotarolimus eluting stent     (ZES). ZES has been known to be associated with significantly more neointimal coverage than     SES at 8 months intravascular ultrasound (IVUS). Both everolimus eluting stent (EES) and ZES     resolute were recently introduced. The efficacy to suppress the neointimal growth for ZES     resolute and EES might be improved, but safety for neointimal coverage needs to evaluate in     human coronary artery. Therefore, this study will investigate the pattern of neointimal     coverage over stent in ZES resolute and EES at 9 months after stent implantation.   "
232360|NCT00894101|"     The purpose of this study is to investigate the clinical value of serial quantitative [F-18]     FLT as a PET imaging tool in head and neck cancer patients clinically scheduled with     radiation or radiation-chemotherapy combination in terms of safety and efficacy. Standard     [F-18] FDG PET will be the active comparator.   "
232361|NCT00894114|"     This study is designed to determine whether patients previously primed with Ad5 of MRKAd5     HIV-1 gag vaccine respond better when boosted with ALVAC-HIV vaccine than when boosted with     MKRAd5 HIV-1 gag vaccine.   "
232362|NCT00894127|"     Primary Objective:        -  To determine the clinical sensitivity and specificity of the Biomoda CyPath™ Early Lung          Cancer Detection Assay using sputum specimens from two cohorts of participants and          estimate the required sample size to finalize a protocol for a pivotal study.      Secondary Objectives:        -  To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay in a          clinical setting to identify cancer cells, as assessed by TCPP labeled cancer cells          demonstrating red fluorescence under a microscope with ultraviolet (UV) light being          observed with a FITC (Fluorescein isothiocyanate) Filter.        -  To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay to          detect pre-invasive cancer in comparison with PAP sputum cytology and routine CT scan.   "
232363|NCT00894140|"     The purpose of this study is to determine if the Silent™ hip, when used as part of an     artificial hip joint, is stable and effective in treatment of patients with joint disease     requiring a total hip replacement. Patients who enter the study will be evaluated at regular     intervals following hip surgery using patient, clinical, standard and special x-rays (RSA) to     allow the position of the Silent Hip within the bone to be accurately monitored.   "
232364|NCT00894153|"     This is multicenter, open-label, randomized, active-controled, phase IV study of local direct     intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , with concurrent     radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in     advanced stage .   "
232401|NCT00894504|"     In this Phase II trial, the investigators will evaluate the combination of gemcitabine,     carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative     breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be     examined for the presence of various markers, including K-ras and PI3K-activating mutations,     EGFR, PTEN, and p53. Correlation of tumor response with marker expression may define a     patient subset that is particularly responsive to treatment with a panitumumab-containing     combination.   "
232402|NCT00894517|"     This is a 24 week study evaluating the effects of botulinum toxin Type A on semen quality in     patients with signs and symptoms of Benign Prostatic Hyperplasia (BPH).   "
232403|NCT00894530|"     The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic     solution, 1% versus placebo over a four-week treatment period.   "
232528|NCT00896948|"     RATIONALE: Studying proteins in head and neck cancer cells in the laboratory may help doctors     learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking at proteins in head and neck cancer cells.   "
232365|NCT00894166|"     Nicotine replacement therapy (NRT) is a well-tolerated and efficacious smoking cessation     treatment, and yet many smokers fail to quit using NRT. Many of these smokers may benefit     from prescription treatment alternatives, including Zyban or Chantix. In this study, the     investigators propose to develop and evaluate a stepped-care treatment algorithm that would     evaluate whether smokers who receive treatment with NRT should be supplemented with Zyban or     switched to Chantix only based on: 1) their initial response to NRT; and 2) individual     genetic factors found to predict smoking cessation in other studies evaluating these     treatments. This study is a continuation of our previous studies showing that abstinence     rates can be increased by starting nicotine patch therapy two weeks before the quit date. The     investigators will provide pre-cessation NRT to all participants initially. Those who do not     show a favorable response on early indicators of success (e.g., smoking in the first week     after the target quit-smoking date) will receive rescue treatment by having their NRT     treatment supplemented with Zyban , by being switched to treatment with Chantix or will     remain on NRT (control).      The investigators hypothesize that Rescue treatment with Zyban in combination with NRT or     Chantix will increase success rates over leaving subjects on NRT when they are NRT     insufficient responders, i.e. they have shown an unfavorable response to NRT in the first     week pre-quit or the first week post-quit.   "
232366|NCT00894179|"     Purpose: The investigators plan to test a newly FDA approved pharmacologic stress agent,     Regadenoson, in conjunction with atropine in the use of stress echocardiography for the     diagnosis of coronary artery disease. The selective nature of Regadenoson allows for its use     in patients with contraindications to the currently used drug, Adenosine, which is     non-selective. Furthermore, the proposed protocol can be completed faster and without     radiation exposure than the current protocol with adenosine.      Design: This is a prospective study evaluating people with no prior diagnosis of coronary     disease with a prior stress test and are scheduled for cardiac catheterization. Patients who     meet inclusion criteria will undergo regadenoson-atropine echocardiography protocol prior to     their catheterization. The study will be interpreted by two independent readers blinded to     the catheterization results. The sensitivity, specificity, positive and negative predictive     values of the regadenoson-atropine study will be then be calculated using the coronary     angiogram as a gold standard.   "
232367|NCT00894192|"     The purpose of this study is to assess the level of visual functioning in patients with     various eye conditions while wearing different types of eyeglasses.   "
232368|NCT00894205|"     This study aims to examine the benefits to thinking processes of a low intensity,     strengthening exercise program for older adults.   "
232369|NCT00894218|"     Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at     patients suffering from degenerative osteoarthritis of these articulations with medium and     long-term good results. The main objective of this study is to compare the efficiency in     short and medium-term functional impact parlance of two surgical techniques:     computer-assisted surgery and mini-invasive surgery compared to the conventional techniques     thanks to an innovative technology of ambulatory analysis of walking.   "
232370|NCT00894231|"     The purpose of this study is to noninvasively measure the anti-inflammatory effect of     levocetirizine after two weeks of treatment in allergic rhinitis subjects.   "
232371|NCT00894244|"     This study is being done to measure the amount of skin shrinkage caused by a non-invasive     skin tightening device.   "
232383|NCT00888524|"     Objectives: To evaluate the effect size on non-specific chronic low back pain (CLBP) of     evidence-based physiotherapy (EBP) with and without the addition of deep water running (DWR)     on pain, physical disability and general health state.      Materials and methods: Randomized, double-blind, controlled trial (therapists and assessors)     involving 46 persons with CLBP over 15 weeks with two interventions, presented three times a     week. Each group received EBP (personalized exercise program, manual therapy and health     education) while one group performed supplementary 20 min sessions of DWR at the     individualized aerobic threshold. Measurements were made pre and post intervention for pain,     disability and general health. Range of motion of lumbar spine in the sagittal plane, maximum     isometric strength and muscle endurance of lumbar and hip extensors was assessment.   "
233047|NCT00904293|"     The purpose of the investigators' study is to determine the clinical utility of a     warfarin-dosing algorithm that incorporates genetic information (VKORC1 and CYP2C9 alleles)     for adult patients initiating warfarin therapy.   "
232372|NCT00894257|"     According to the centres taking part in the ALHICE survey, the number of HIV-HCV co-infected     women is currently decreasing. This drop was first noted in 2006 and persisted in 2007. What     might have been considered a chance phenomenon during the first year (2006) was confirmed in     the beginning of 2008. In view of this information, the investigators wished to ascertain the     reality of this trend and to investigate its causes, by attempting to answer the following     questions: - Has the prevalence of risk factors for HCV infection changed among the general     population over the past 10 years?        -  Has the prevalence of risk factors for HCV infection changed among HIV/HCV co-infected          women over the past 10 years?        -  Is the change in the number of co-infected women who gave birth during the past 10 years          related to the prevalence of certain risk factors among this population?        -  Is the change in the number of co-infected women who gave birth during the past 10 years          related to a decrease in certain risk factors for HCV infection among the general          population?        -  Have changes in addictive behaviour among women of child-bearing age played a role in          the decreasing number of HCV-contaminated children? Furthermore, follow-up data from          HCV-infected children born during this period will provide information concerning the          course of HCV infection.      The objectives are to study trends in numbers of deliveries among HCV/HIV co-infected women     as well as trends in risk factors for HCV infection among women of child bearing age and     lastly to create a cohort of HCV infected children.   "
232404|NCT00894543|"     The purpose of this study is to test whether a medication reduces the number, severity and     bothersomeness of menopausal hot flashes. Escitalopram (also called Lexapro®) is a selective     serotonin reuptake inhibitor (SSRI). It is sold by prescription for depression and general     anxiety disorder. An SSRI increases serotonin, a brain substance that is believed to     influence mood. Serotonin may also affect brain levels of estradiol, a hormone related to hot     flashes. This research study will test whether escitalopram reduces menopausal hot flashes.   "
232373|NCT00894270|"     Children and adolescents with type 1 diabetes mellitus are required to inject insulin daily.     The injection technique should reliably deposit insulin into subcutaneous fat while     minimizing inadvertent delivery into either the skin or the underlying muscle, both of which     are associated with suboptimal outcomes. The use of shorter, thinner needles reduces the     incidence of intramuscular delivery and is associated with reduced discomfort, but increases     the risks of both shallow (intradermal) delivery and of loss of insulin through backflow to     the skin surface.      In the current study, 240 subjects (children and adults) will receive multiple injections of     small volumes of sterile air in the thigh and abdomen using 5 mm Novofine® needles, to     simulate insulin injections performed at the two sites using various injection techniques     (perpendicular or angled needle, with or without skin fold). Ultrasound visualisation of the     injected air will allow determination of the incidence of intradermal or intramuscular     delivery using the various delivery methods in the trial. In addition, adult subjects will     receive injections of a liquid test medium in order to determine the incidence and extent of     backflow. Qualitative data on perceived discomfort and information on body composition will     also be collected. This investigation will form the basis for recommendations regarding     preferred injection technique where 5 mm needles are used.   "
232374|NCT00894283|"     This pilot study is designed to determine the feasibility of conducting a randomized clinical     trial comparing fondaparinux sodium (Arixtra) once daily with enoxaparin (Lovenox®) twice     daily with respect to preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after     bariatric surgery in obese patients.   "
232375|NCT00894296|"     The objective of the suggested study is to identify changes in MEG correlates caused by the     add-on treatment with the changes in negative symptoms of schizophrenia by comparing the     change in the MEG correlates of the subjects before and during usage of new add on treatments     for negative symptoms.      The investigators hypothesize that the gravity of negative symptoms will correlate with a     trend towards more aberrant electroencephalographic correlates mainly in continuous     parameters, with an emphasis on alpha and delta bands   "
232376|NCT00888433|"     An international, multi-center, prospective, randomized, controlled study of the safety and     effectiveness of renal denervation in patients with uncontrolled hypertension.   "
232377|NCT00888446|"     This phase 2 study will evaluate the safety, immunogenicity and optimal timing of two     injections at three dose levels of the tgAAC09 vaccine in healthy volunteers. Study     volunteers will receive two intramuscular injections of tgAAC09 or placebo at Months 0 and 6     (groups A, C, E and G) or at Months 0 and 12 (groups B, D and F) and be followed for a total     of 18 months following the first injection with the exception of group G in which volunteers     will be followed for 12 months after the first injection (6 months after the second     injection). This study will explore whether boosting is possible, and compare a shorter and     more practical six-month time interval with a twelve-month time interval.   "
232378|NCT00888459|"     The investigators are hypothesizing that by offering both self-help materials and mailed     nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users,     as well as decrease tobacco withdrawal.   "
232379|NCT00888472|"     Extracorporeal leukocytapheresis (LCAP) or granulocytapheresis (GCAP) has been used in the     treatment of patients with rheumatoid arthritis and ulcerative colitis and has shown     promising safety and efficacy. LCAP and GCAP seem to be effective for steroid-resistant     inflammation. The investigators have already reported safety and efficacy of GCAP in     refractory asthma and expect the beneficial effect of LCAP in refractory asthma. In this     study, in order to improve the therapeutic effect of LCAP by increasing the quantity of     leukocytes that were removed, the investigators conducted a clinical study to investigate     safety and efficacy of high-dose LCAP performed using a larger filter and an increased dose     of the blood volume per body weight treated, as an possible therapy for refractory asthma.   "
232380|NCT00888485|"     The purpose of this study is to determine the possible preventive effect of behavioural     modification versus standard treatment after hospital discharge in CHD patients.   "
232381|NCT00888498|"     The purpose of this study is to determine the effect of using ankle manual therapy procedures     on clinical outcomes in individuals with post-acute ankle sprains.   "
232382|NCT00888511|"     The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in     inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the     phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy     (2 Gy x 33 F, 5 F per week).   "
232384|NCT00888537|"     Patients who are hospitalized because of a heart attack are prescribed a number of medicines     to help the heart heal. The investigators will examine different ways in which clinicians     share information about those treatment options with patients and the impact that this can     have on patients' choices and health.   "
232385|NCT00888550|"     Two standards of care exist with regards to posterior splinting post-operatively. The     proponents of splinting feel the additional immobilization decreases the stress on the soft     tissue, subsequently preventing or limiting pain while improving early range of motion (ROM).     The opposing belief is that the splinting is without therapeutic benefit and that early     mobilization is beneficial. With regards to both practices, the surgeon's practice is     anecdotally based on past experience.      The purpose of this study is to compare the results obtained with and without posterior     splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence     based reasoning to guide future practice.   "
232405|NCT00894556|"     A study to provide evidence supporting the benefit of Rizatriptan in patients who have an     inadequate response to sumatriptan.   "
232406|NCT00894569|"     The purpose of this study is to determine whether an addition of cetuximab to     carboplatin/paclitaxel can improve efficacy in comparison to carboplatin/paclitaxel in     patients with carcinoma of unknown-primary.   "
232452|NCT00895895|"     The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at     three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531,     donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive     placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the     remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage     levels or donepezil in period I will continue with the same study drug (period II).   "
232386|NCT00894309|"     Fluid therapy is an important part of the management of patients with hemodynamic instability     in the intensive care unit. By increasing cardiac preload, it aims at elevating cardiac     output (CO) and thus restoring hemodynamic conditions in patients who are preload responsive.     By contrast, volume administration can be deleterious in terms of pulmonary edema formation     or other manifestations or fluid overload, especially in patients who are not preload     responsive. Functional dynamic parameters that use heart-lung interactions, such as pulse     pressure variation (PPV) and stroke volume variation (SVV) are considered accurate predictors     of preload responsiveness in patients receiving fully controlled mechanical ventilation.      However, in cases of spontaneous breathing activity where heart-lung interaction indices fail     to predict fluid responsiveness, one needs parameters able to reliably predict the     hemodynamic response of fluid administration.      A new index that could indicate fluid responsiveness, so-called the fluid responsiveness     index (FRI), has been elaborated. The advantage is that it could be used in patients who are     not in control mechanical ventilation as well as in patients who are fully adapted to     mechanical ventilation.      The FRI is based upon the analysis of continuous arterial and continuous central venous     pressure. The FRI is determined by the relation of cardiac and respiratory activity; both are     evaluated by means of power spectrum analysis of the pressures recorded.      The aim of this study is to test the value of the FRI to predict the hemodynamic response to     fluid infusion in patients with hemodynamic instability not receiving fully controlled     mechanical ventilation.   "
232387|NCT00894322|"     This study is designed to evaluate the pharmacokinetics, tolerability, and safety of     exenatide once weekly suspension in both healthy subjects and in subjects with type 2     diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development     of this exenatide once weekly presentation would eliminate the need to reconstitute the     product prior to use.   "
232388|NCT00894335|"     This study is a prospective, perioperative evaluation of hemodynamic and respiratory     parameters in patients undergoing retroperitoneoscopic adrenalectomies.   "
232389|NCT00894348|"     To determine factors associated with a positive yield of malignancy on biliary brush cytology     obtained by ERCP.   "
232390|NCT00894361|"     This study will be designed to compare prospectively, in a randomized fashion, the clinical,     functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing     posterior cruciate substituting design with a modular posterior cruciate substituting     rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will     afford the investigators information in the following areas:        1. Does a RP design offer improvement in range of motion over a AP design?        2. Does a RP design have improved wear characteristics over a nonmodular AP design?        3. Is there a clear clinical advantage to the RP design that justifies its increased cost?      Answering these questions will allow surgeons to use RP designs appropriately in different     demand populations.      This study was designed to address the questions of whether an RP design offers improvement     in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of     Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short     Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators'     primary hypothesis was that there would be no difference in these outcome measures at a     minimum two year followup. A secondary hypothesis based on the anticipated long-term followup     of this group was that there would be no difference in implant survival.   "
232391|NCT00894374|"     The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is     pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).   "
232392|NCT00894387|"     This study evaluated the effect of early initiation of aliskiren therapy, compared to     standard therapy, in the reduction of cardiovascular death and heart failure     re-hospitalization events within 6 months, in congestive heart failure (CHF) patients     hospitalized for an episode of acute decompensated heart failure.   "
232393|NCT00894400|"     The purpose of this study is to characterise which fractionated electrogram morphologies are     important to target in the catheter ablation of atrial fibrillation.   "
232394|NCT00894413|"     The purpose of this trial is to determine whether or not Cialis (tadalafil) administered to     head and neck squamous cell cancer patients augments immune response.   "
232395|NCT00894426|"     The aim of this study is to assess the perception of chronic obstructive pulmonary disease     (COPD) patients in symptoms related to morning activities. Also the researchers investigated     how to describe the impact of symptoms on sleep quality and how to use the medication in     Korea COPD treatments.   "
232396|NCT00894439|"     The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given     together to healthy subjects.   "
232397|NCT00894452|"     The purpose of this study is to describe clinical, pharmacokinetic and genetic factors     associated with the variance of oral methadone dosage for patients at the steady state of     heroin dependence maintenance treatment. The hypothesis is that the investigators can predict     70% of the variance with few factors, including CYP 3A4 function measured with oral midazolam     challenge.   "
232398|NCT00894465|"     The purpose of this research is to validate the common administration of oral midazolam to     children prior to voiding cystourethrogram (VCUG) to see if this will significantly decrease     children's anxiety and make the experience less traumatic.   "
232432|NCT00895635|"     Peripheral arterial disease (PAD) is a disorder that affects more than 8 million people in     the United States. As a result of decreased blood flow to the legs, people with PAD may     experience leg pain and difficulty with walking. This study will examine the effectiveness of     two exercise programs—a treadmill walking program and an aerobic arm exercise program—at     increasing walking distance and decreasing leg pain in people with PAD.   "
232399|NCT00894478|"     Focal cortical dysplasia is one of the most common lesions responsible for medically     refractory epilepsy in the pediatric population. In patients with medically intractable     epilepsy, surgery is the only treatment that will lead to seizure freedom. The outcome of     epilepsy surgery is worse in patients when there is no lesion identified on routine     structural MRI, also known as MRI-negative partial epilepsy. Diffusion tensor imaging (DTI),     a novel MRI technique, can be used to evaluate the integrity of the microstructure of the     white matter, even when the white matter appears normal on routine MRI.   "
232407|NCT00894582|"     Immediate post-operative abdominal compartment syndrome is a feared complication after hernia     repair in patients with a loss of abdominal domain. Replacement of the viscera within an     unyielding stiff abdominal wall may compromise the perfusion of the intestines, elevate the     diaphragm, and interfere with ventilation. The components separation technique, used to     repair these massive hernias, employs bilateral relaxing incisions in the external oblique     muscle and fascia in order to approximate the rectus abdominis muscles in the midline.     Reducing a large volume hernia into the abdominal cavity and primary closure of the abdominal     wall should cause problems both with abdominal compartment pressure and with postoperative     ventilation, but in the investigators' 13-year experience with over 250 cases, this has not     been seen clinically, and the investigators sought to understand why. The investigators'     hypothesis is that releasing the rectus muscles from the external obliques expands the     intra-abdominal compartment, reclaims lost domain, and thus reduces abdominal pressure and     respiratory problems. The investigators have previously reported increased abdominal volumes     using the components separation technique in a retrospective series, but patients were not     standardized for the collection of data, and no pulmonary function tests were obtained in     that series (Hadad, in press). The purpose of this study was to prospectively analyze the     effect of this surgical technique on abdominal volume and pulmonary function.   "
232408|NCT00894595|"     Football-related knee injuries are common and especially the anterior cruciate ligament (ACL)     injury constitute a serious problem in football regardless of the playing level. The purpose     of this study is to conduct a randomized controlled trial evaluating the effect of a training     program designed to prevent acute knee injury in female adolescent football players.      The investigators' hypotheses are:        1. a preventive training program reduces the incidence of ACL injury, and        2. a high match frequency and match play at senior level increase the risk of ACL injury.   "
232409|NCT00894608|"     The purpose of this study is to determine whether letrozole combined with gonadotropins are     effective in the ovarian hyperstimulating for IVF/ICSI in patients with PCOS.   "
232410|NCT00894621|"     The purpose of this study is to assess the effectiveness from early infusion of     norepinephrine in pediatric patients submitted to mechanical ventilation for the use of     sedative and analgesics drugs.   "
232411|NCT00894634|"     The objective of this study is to characterize the pharmacokinetic (PK) profile of     brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years     following dosing in accordance with current weight-age dosing guidelines. Once characterized,     the PK data will be pooled with adult PK data from other studies and analyzed under a     separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to <12     yrs and adolescents aged 12 to <18 yrs.   "
232412|NCT00895375|"     The purpose of this study is to compare the sleep quality of patients with psoriasis to     patients without psoriasis.   "
232413|NCT00895388|"     Quality of life after rectal surgery is reported to be impaired. Side effects of surgery     and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary     incontinence, anal incontinence or stoma problems are commonly experienced. The investigators     hypotheses is that structured rehabilitation program addressing these problems will improve     quality of life. A RCT are performed in order to document the effects of the rehabilitation.   "
232414|NCT00895401|"     This is a Phase IV randomized controlled study assessing the effectiveness of a commercially     available nutritional supplement on malnourished prevalent hemodialysis patients. Patients     will be randomized to either receive one can of Nepro with Carb Steady at each dialysis     treatment for 6 months or to receive the standard of care counseling for malnutrition. The     primary hypothesis is that hypoalbuminemic maintenance hemodialysis patients will demonstrate     an improvement in albumin levels with oral nutritional supplement provided in-center thrice     weekly in addition to standard of care as compared to malnourished maintenance hemodialysis     patients provided standard of care alone.   "
232415|NCT00895414|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Enalapril maleate may help protect heart cells from the side effects of     chemotherapy. It is not yet known whether giving enalapril maleate before or after     doxorubicin hydrochloride is more effective in treating women with breast cancer.      PURPOSE: This randomized clinical trial is studying giving enalapril maleate together with     doxorubicin hydrochloride to see how well it works in treating women with breast cancer.   "
232416|NCT00895427|"     This study examines the relationship between the SCOUT DM device and coronary artery     calcification as determined by rapid computed tomography in patients at risk for coronary     heart disease.   "
232417|NCT00895440|"     Diabetes mellitus can result in damage to the nerves supplying the feet. Various tests can be     used to assess nerve damage but no tests so far have been used to assess loss of sweating     which can lead to dry skin, fissuring and ulceration. The indicator test (Neuropad) is a     plaster which is applied to the sole of the feet just below the 1st and 2nd toes of both     feet. If the color of the plaster changes to pink it indicates that there is no nerve damage     to the nerves. However if the plaster retains the blue color or the color only partially     changes to pink after 600 seconds then this is a positive test and the patient has nerve     damage.   "
232418|NCT00895453|"     A prospective study to evaluate the efficacy of classic homeopathic therapy compared to     maintenance itraconazole therapy with and without additional exogenous lactobacillus for     treatment of recurrent Candida vaginitis.   "
232419|NCT00895466|"     The purpose of this trial is to investigate whether treatment with this new drug will result     in lower testosterone levels in men with prostate cancer. At the same time it will be     investigated whether the drug induces side effects, and if so, which ones.   "
232447|NCT00895830|"     To assess the efficacy and safety of different doses of APD405 in the prevention of     post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV.     Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any     surgical technique), cholecystectomy (any surgical technique) or other elective surgery     scheduled to last at least one hour from induction of anaesthesia), requiring at least one     overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past     history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use     for post-operative analgesia.   "
232420|NCT00895479|"     Patients in renal failure on hemodialysis depend on adequate and sustained vascular access.     This can be achieved by surgical placement of a synthetic polytetrafluoroethylene (PTFE)     graft. These patients frequently experience graft complications arising from the development     of smooth muscle cell (SMC) neointimal hyperplasia in the proximity of the graft-vein     anastomosis. Such complications eventually lead to stenosis, access thrombosis and graft     failure. Trinam® is being developed to prolong graft survival. It is a combination product     consisting of a replication deficient Adenovirus containing the human Vascular Endothelial     Growth Factor D (Ad-VEGF-D) gene and a biodegradable local delivery device (collar) made of     collagen. At the end of the surgical procedure to insert the PTFE graft the collagen collar     is applied around the anastomosis and sealed with a collagen surgical sealant. This procedure     creates a reservoir between the site of anastomosis and the collagen collar. The adenoviral     vector is then injected into this reservoir, localizing the expression of the transgene to     the site of the anastomosis. Expression of VEGF-D has been shown to have a vascular     protective role and inhibit SMC neointimal proliferation, therefore expression of VEGF-D     should prolong graft survival.   "
232421|NCT00895492|"     The purpose of this study is to prospectively determine the rotavirus VP7/VP4 genotypes     associated with moderate to severe disease (requiring emergency room (ER) consult or     hospitalization) in a large public hospital from Valparaiso and another from Santiago.   "
232422|NCT00895505|"     This clinical trial will investigate the hypothesis that D-Dimer testing can be successfully     used to tailor the duration of OAT in patients after an unprovoked episode of deep venous     thrombosis (DVT) using a prospective, randomized, and controlled design.   "
232423|NCT00895518|"     This study will examine the use of prolonged exposure therapy on people who have recently     experienced a trauma to prevent them from developing post-traumatic stress disorder.   "
232424|NCT00895531|"     The investigators hypothesize that patients who receive a femoral catheter with low dose     epidural Depodur will experience comparable or superior pain relief than those who receive     both femoral and sciatic catheters. In addition, the investigators hypothesize that the one     catheter will be less time consuming to place and facilitate early ambulation of the patient.   "
232425|NCT00895544|"     The main objective of the study is to assess the immune response to a non-adjuvanted H5N1     influenza vaccine in an adult population when administered according to a single prime-boost     schedule.   "
232426|NCT00895557|"     Our proposal will enable us to study cocaine patients to determine whether varenicline can     weaken brain arousal to drug cues in an fMRI imaging setting, which is what we theorize. This     supplement supports a pilot imaging study in cocaine dependence. It will evaluate the impact     of varenicline on the brain response to ultra-brief drug and comparison cues in an     event-related fMRI paradigm. This is a pilot study.      We will additionally examine the impact of varenicline on addiction-relevant behavioral     probes of impulsivity, inhibition, attentional and affective bias. The proposed study will     provide the first brain-behavioral probes of varenicline's cocaine-relevant actions in     humans, and will provide the critical scientific rationale to move the agent into future     collaborative clinical trials.   "
232427|NCT00895570|"     The purpose of the study is to examine the effects of sleep and modafinil on how the body     processes glucose.   "
232428|NCT00895583|"     This study will look at the effect on long-term kidney function using tacrolimus right after     a transplant and then switching to sirolimus at 3 to 5 months after the transplant.   "
232429|NCT00895596|"     The purpose of the study is to investigate the safety and the antiviral activity of ascending     multiple oral doses of LB80380 for 12 weeks in adults with lamivudine-refractory chronic     hepatitis B infection.   "
232430|NCT00895609|"     This study is designed to compare recovery times after reversal of a residual neuromuscular     block (TOF-ratio 0.5) with different doses of either neostigmine or sugammadex.   "
232431|NCT00895622|"     RATIONALE: Sometimes a tumor may not need treatment until it progresses. In this case,     observation may be sufficient. Specialized radiation therapy that delivers a high dose of     radiation directly to the tumor, such as 3-dimensional conformal radiation therapy and     intensity-modulated radiation therapy, may kill more tumor cells and cause less damage to     normal tissue. It is not yet known whether observation is more effective than radiation     therapy in treating patients with meningioma.      PURPOSE: This phase II trial is studying observation to see how well it works compared with     radiation therapy in treating patients with grade I, grade II, or grade III meningioma.   "
232433|NCT00895648|"     Despite the best surgical efforts, complete removal of mesothelioma is possible in     approximately 30% of the patients. When surgical removal is complete, chemotherapy followed     by radiation therapy is recommended as an effort to improve control over the cancer and     survival. This combination of treatments is called TRIMODALITY therapy. Unfortunately, the     chances for the tumor coming back after TRIMODALITY therapy remains high. When surgical     removal is not complete or not possible, some patients may receive chemo and/or radiation     therapy to achieve control over the cancer, but the chances of tumor to growth again remains     high and the chances of long term survival remains low.      The combination of Pemetrexed (Alimta) with Cisplatin has been approved as one of the     standard chemotherapy drug combinations for the treatment in advanced Malignant Pleural     Mesothelioma, and there is likely a group of patients who may benefit and potentially be     cured by this therapy. In an effort to achieve a better chance of complete removal of the     cancer and long term survival, the investigators are interested in using this drug     combination of Pemetrexed + Cisplatin before surgery and offer radiation therapy after     surgery.   "
232434|NCT00895661|"     The purpose of this clinical trial is to see if increased doses of rituximab are safe and     effective for the initial treatment of indolent B-cell lymphomas. Rituximab (Rituxan) is a     type of drug called an antibody that specifically targets B-cell lymphoma cells, and is     approved by the FDA for the treatment of indolent B-cell non-hodgkin lymphomas and certain     other types of non-hodgkin lymphomas. Standard doses currently used may not be achieving     maximal efficacy. Higher doses have been shown to be safe in other clinical trials, and may     offer superior efficacy to the current standard dose. This trial also employs intermittent     maintenance doses of rituximab at the standard dose, which has been shown to prolong     remissions and survival in patients with relapsed indolent B-cell lymphomas. This trial is     designed to show that higher dose rituximab plus maintenance rituximab can achieve similarly     good results to chemotherapy approaches, but without chemotherapy-related toxicity.   "
232435|NCT00895674|"     Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer     type, which means that patients who present with an advanced disease have a rather poor     prognosis. When this study has been started the standard therapy for patients has been     cytokines, which might be accompanied by significant toxicities or might fail the therapeutic     goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional     study has been created and is being conducted to collect clinical data on the patients'     therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses     on patient characteristics and tumor status in RCC treated with sorafenib as well as the     treatment duration and safety of sorafenib under everyday treatment conditions.   "
232436|NCT00895687|"     The goal of this clinical research study is to find the highest tolerable dose of Tarceva     (erlotinib hydrochloride) that can safely be given in combination with Velcade (bortezomib).     The safety of this drug combination will also be studied.   "
232437|NCT00895700|"     The implantable cardioverter defibrillator (ICD) is generally well-accepted by patients, but     a subgroup experiences increased anxiety and poor quality of life. A web-based behavioral     intervention may comprise a novel approach to reduce anxiety and enhance well-being in ICD     patients, which may be equally effective and have advantages over more traditional forms of     therapy, due to its low-threshold accessibility via the internet.      The purpose of this study is to determine whether patients receiving a behavioral     intervention via the internet experience less anxiety and device concerns and improved     quality of life compared to patients receiving usual care.   "
232438|NCT00895713|"     The purpose of this study is to determine if treatment with intramuscular hepatitis B virus     immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe     for the prevention of hepatitis B virus recurrence after orthotopic liver transplantation.   "
232439|NCT00895726|"     Primary Objective:      To assess the efficacy of APD209 in adult patients with active cachexia associated with     advanced malignancy and not caused by simple starvation.      Secondary Objective:      To assess the safety of APD209 in patients with advanced malignancy and active cachexia.   "
232440|NCT00895739|"     RATIONALE: Immunosuppressive therapies, such as alemtuzumab and cyclosporine, may improve     bone marrow function and increase blood cell counts. Giving alemtuzumab together with     cyclosporine may be an effective treatment for severe aplastic anemia or acquired marrow     failure.      PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with     cyclosporine and to see how well it works in treating patients with severe aplastic anemia or     acquired marrow failure.   "
232441|NCT00895752|"     The purpose of this study is to investigate the effectiveness and tolerability of riluzole in     adults with Fragile X Syndrome.   "
232442|NCT00895765|"     The purpose of this study is to investigate the lesions, clinical features and outcome in     young children with melamine-related-calculus.   "
232443|NCT00895778|"     This study is designed to test the clinical hypothesis that a neuromuscular block improves     surgical conditions, operation time, and post-operative pain.   "
232444|NCT00895791|"     The aim of this study is to compare vessel healing at 9 months using OCT imaging for two     different treatment techniques for treating bifurcation lesions. Quantitative assessment of     OCT images will be used to assess re-endothelialization and quality of strut apposition to     the vessel wall.   "
232445|NCT00895804|"     MDMA (3,4-Methylenedioxymethamphetamine, Ecstasy) produces tachycardia, hypertension,     hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare     cardio- and cerebrovascular complications. The role of beta-blockers in the treatment of     cardiovascular and adverse effects of MDMA is unknown.   "
232467|NCT00896090|"     This study is being done to determine whether measures of brain activity (known as cortical     excitability and inhibition) collected by Transcranial Magnetic Stimulation (TMS) are     different in children and adolescents with depression and children and adolescents that do     not have depression.   "
232468|NCT00896129|"     Rationale: At present, virtually no evidence exists regarding mid to long-term     patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients     treated with Imatinib.      Purpose: the results of this research will provide preliminary evidence-based data on an     number of issues from the patients' perspective, including adherence to therapy issues.   "
232469|NCT00896142|"     To evaluate the impact of left ventricular (LV) lead location on LV mechanical function.   "
232446|NCT00895817|"     The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in     comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis     (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and     food impaction. The presence of anatomical abnormalities in the esophagus such as     longitudinal furrows, corrugated rings and a narrow caliber esophagus with friable mucosa are     classic endoscopic findings. Diagnosis is established with the histologic finding of large     numbers (> 15) of eosinophils per high power field. The underlying pathologic mechanism     remains poorly understood but food allergies and aeroallergens have been implicated. It is     well known that gastroesophageal reflux disease (GERD) may cause esophageal eosinophilia, but     it is unclear whether a complex relationship exists between GERD and EE, as recent data     suggests. Furthermore, a large number of patients with clinical presentations and endoscopic     findings highly suggestive of EE which is confirmed on histology are responding favorably to     proton pump inhibitors.      The aims of the study are to (1) compare the clinical efficacy of aerosolized swallowed     Fluticasone to Esomeprazole for the treatment of eosinophilic esophagitis, (2) determine     whether proton pump inhibitors are effective in the treatment of eosinophilic esophagitis,     (3) determine the number of patients with eosinophilic esophagitis that have coexisting     gastroesophageal reflux disease, and (4) correlate change in eosinophil count to improvement     in symptoms before and after therapy.   "
232448|NCT00895843|"     The purpose of this study is to investigate whether robust analgesic regime (protective     analgesia) can improve postoperative pain experience for patients undergoing lower wisdom     teeth extraction under day case general anaesthetic.   "
232453|NCT00895908|"     This study will determine the effectiveness of an intervention for preventing at-risk     kindergarten and pre-kindergarten children from developing attention deficit hyperactivity     disorder.   "
232455|NCT00895934|"     The purpose of this study is to test the safety of vorinostat (Zolinza) and azacitidine     (Vidaza) when combined with gemtuzumab ozogamicin (GO) at different dose levels. These drugs     increase the effect of GO against leukemia cells in the test tube, but we don't know yet     whether they also increase the anti-leukemia effect of GO in people.   "
232456|NCT00895947|"     The aim of the study is to see if lozenges containing a low dose of interferon-alpha can     prevent and/or reduce the severity of colds and flu. Starting about 1 month before the     expected start of the winter colds and flu season in Perth, Australia, healthy volunteers     will allow a lozenge containing interferon, or a lozenge containing no medicine (a placebo),     to dissolve in their mouth once a day for 16 weeks. Blood tests at the start and end of     treatment will determine whether interferon was able to prevent infections with cold/flu     viruses. Once a week, volunteers will complete a survey about their cold/flu symptoms,     medications taken, days of work missed, etc. to see if interferon was able to make their     winter colds and flu less severe.   "
232470|NCT00896155|"     Two hundred and sixty patients with breast cancer will be accrued into the study. After     inclusion in the study, all the patients will be randomized into two arms. Arm 1 will receive     Tamoxifen given concurrently with radiotherapy while in Arm 2 radiotherapy will be given     followed by tamoxifen sequentially. The patients will be stratified for the following     factors: a) BCS (Breast conservative surgery) versus MRM (modified radical mastectomy) and b)     central lung distance (CLD) > 2 cm.      Patients in both arms will continue tamoxifen for a period of 5 years. The patients will be     evaluated by high-resolution computed tomography (HRCT) (baseline and at 2 years), serum     transforming growth factor (TGF) beta levels (baseline and at 6 months) and     diethylenetriaminepentaacetic acid (DTPA) aerosol clearance half life (baseline and at 6     months).   "
232471|NCT00896168|"     The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate     (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune     disease that causes pain, swelling, stiffness and loss of function in joints) in participants     with moderate disease versus participants with severe disease and to compare the efficacy and     safety of the MTX subgroups.   "
233048|NCT00904306|"     The purpose of this study is to test the feasibility and preliminary efficacy of a 6-month     chromium picolinate (CrPic) treatment trial in binge eating disorder (BED).   "
232457|NCT00895960|"     Phase I:      Primary Objectives:      -To define the maximum tolerated dose (MTD) of dasatinib (Sprycel) with radiotherapy (RT) and     6 weeks of concomitant temozolomide (TMZ) administered at 75 mg/m^2/day in patients with     newly-diagnosed glioblastoma (GBM).      Secondary Objectives:        -  To characterize the safety profile of dasatinib (Sprycel) in combination with          radiotherapy (RT) and concomitant TMZ in patients with newly-diagnosed GBM.        -  To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant          TMZ in patients with glioblastoma after RT.      STUDY DID NOT PROGRESS TO PHASE II PORTION.      Phase II:      Primary Objectives:      -To determine the effectiveness of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of     concomitant temozolomide (TMZ) administered at 75 mg/m^2/day followed by adjuvant     temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma (GBM) as     measured by overall survival.      Secondary Objectives:        -  To determine the efficacy of this treatment as measured by radiographic response (RR),          progression-free survival (PFS) and time to progression (TTP).        -  To characterize the safety profile of dasatinib (Sprycel) in combination with RT and          concomitant TMZ in patients with newly-diagnosed GBM.        -  To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant          TMZ in patients with GBM after RT.      Exploratory Objectives:      -To correlate tumor genotype, tumor expression of dasatinib target proteins (e.g. Src, EphA2,     c-kit and PDGFR), and PTEN levels with response to therapy with dasatinib and temozolomide.   "
232458|NCT00895973|"     The investigators hypothesize that the rate of perineal lacerations in nulliparous women will     be reduced by a simple change in common obstetrical delivery practice, i.e., bed delivery     versus conventional delivery in obstetrical stirrups.   "
232459|NCT00895986|"     Many people with type 2 diabetes are not able to keep their blood glucose in good control.     Improving blood glucose control and maintaining that improvement is important for diabetes     patients because doing so delays the onset and progression of severe complications of     diabetes. Although educational programs may be helpful, their effect is not always     long-lasting. This project is studying whether the Conversation Maps program (an interactive     diabetes education program) reinforces diabetes education and information and thus helps type     2 diabetes patients take better care of their diabetes and blood glucose levels. Half of the     patients will attend the Conversation Maps program and half of the patients will attend an     educational program about blood pressure and cholesterol. Also, all patients will come in for     4 or 5 appointments to complete surveys and other tests and have their blood drawn. The group     of patients who attend the Conversation Maps program will be compared to the group of     patients who attend the blood pressure and cholesterol program to see if the educational     programs helped diabetes patients to improve their diabetes control and quality of life and     to maintain that improvement over time.   "
232460|NCT00895999|"     Patients with depression and pain have poorer outcomes in response to depression treatments     than depressed patients without pain. While psychotherapy treatment studies have demonstrated     improvement in pain and depression, no psychosocial interventions have been developed and     tested prospectively specifically for patients with both conditions. Interpersonal     psychotherapy (IPT), an effective treatment for depression, has been adapted successfully for     physically ill patients and demonstrates good adherence, treatment satisfaction, and     depression outcomes. The investigators propose to test a modified form of IPT-P for depressed     patients with co-morbid pain.   "
232483|NCT00896324|"     RATIONALE: Breast cancer and its treatment may cause changes in a patient's ability to think,     learn, and remember. Gathering information about a woman's genes, brain function, and     personal history may help doctors learn more about the disease and plan the best treatment.      PURPOSE:        1. To determine changes in brain function that occur following breast cancer chemotherapy.        2. To gain further understanding of the individual differences in brain function changes          and recovery based on demographic, medical and treatment variables.   "
232484|NCT00896337|"     The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary     stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.   "
232461|NCT00896012|"     Current therapy to prevent organ rejection relies on the use of calcineurin inhibitors either     cyclosporine or tacrolimus. Although these agents have been very successful in preventing     early acute rejection, this success has not translated into improved long-term kidney     transplant function. One of the important factors that leads to premature kidney transplant     failure is chronic allograft nephropathy (CAN). CAN is characterized by progressive     interstitial fibrosis or scarring, vascular wall thickening, and finally glomerular     sclerosis leading to slow progressive loss of kidney function. Calcineurin inhibitors have     been shown to play an important role in the pathogens of CAN. Renal transplant recipients in     whom calcineurin inhibitors are discontinued enjoy better and longer kidney function.     Therefore, immunosuppressive strategies are being designed with the intention of withdrawing     calcineurin inhibitors.      The purpose of this trial is to test if tacrolimus can be safely substituted by sirolimus     (Rapamycin) and this substitution will yield improved renal function, less CAN and better     graft survival rates over the first year.   "
232462|NCT00896025|"     This proposed study is a multi-center open label study to determine if N-acetylcysteine has     any survival benefits in patients with ALF.   "
232463|NCT00896038|"     Objective:      Alcoholism is highly co-morbid with post traumatic stress disorder (PTSD). Since stress and     negative affective states are major relapse triggering factors for alcohol use, the negative     symptoms associated with PTSD are thought to promote alcohol dependence. Substance P, which     is released in the amygdala in response to stress, acts at NK1 receptors (NK1Rs) to mediate     behavioral stress responses. Blockade of the NK1R represents a novel approach for anti-stress     actions. In a recent double blind, placebo controlled study involving detoxified anxious     alcoholics, we found that NK1R antagonism decreased alcohol cravings, attenuated cortisol     response to stress, and significantly decreased insula activation in response to negative     sensory input. The present study is intended to expand the findings and determine whether the     NK1R is a candidate target for treating alcohol dependent patients with PTSD.      Study Population:      On hundred twenty participants with PTSD and co-morbid alcohol dependence will be recruited     and stratified by PTSD etiology (60 participants each with civilian and combat PTSD, resp).     Within each stratum, the treatment groups will be balanced for sex using urn randomization.     Stratification is indicated since civilian and combat-related PTSD can theoretically have a     different pathophysiology. Civilians typically experience a single trauma exposure of     invariably high magnitude, resulting in symptoms immediately. Combat-related PTSD typically     results from multiple traumatic exposures over a prolonged period of time, of variable     magnitude, and frequently with delayed emergence of symptoms.      Design:      Participants will be admitted to the National Institute on Alcohol Abuse and Alcoholism     (NIAAA) research inpatient unit at the NIH Clinical Research Center (CRC) under protocol     number 05-AA-0121 for assessment and treatment of people with alcohol drinking problems,     which provides diagnostic assessments and standard withdrawal treatment if needed.     Participants will enter into the present protocol once such treatment, if needed is     completed. Following inclusion, all participants will receive 1 week of single blind placebo,     and will then be randomized to double blind treatment with aprepitant or placebo. Randomized     treatment will be for 3 weeks. Spontaneous cravings for alcohol, and ratings of     psychopathology will be obtained twice weekly on the inpatient unit throughout the study.     Cravings as well as endocrine and immune responses will also be assessed in a challenge     session that combines a social stressor and exposure to physical alcohol cues. During the     final week, three sessions utilizing scripts will be carried out, on separate days in     counter-balanced order, exposing the participant to personalized trauma, alcohol-associated     or neutral stimuli. Cravings as well as endocrine and immune responses will also be assessed     during the script presentations. A functional magnetic resonance imaging (fMRI) session will     be carried out last to assess responses to affective stimuli. Participants will remain     hospitalized throughout the study, and will remain on the unit for a three day     post-medication monitoring period.      Outcome Measures:      The primary outcome will be craving alcohol and changes in PTSD symptoms resulting from the     script sessions. Secondary outcomes will include cravings and changes in PTSD symptoms     resulting from the combined social stress-alcohol cure challenge session, spontaneous craving     and PTSD symptoms during hospitalization, and brain responses on the fMRI session. Changes in     PTSD symptoms and cravings for alcohol are intended to be surrogate markers for the overall     effect of the drug treatment and are not intended to represent global improvement for either     PTSD or alcoholism.   "
232464|NCT00896051|"     The purpose of this study is to determine the pharmacokinetics (how the body absorbs,     distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1     NRTI in treatment experienced HIV-1 infected patients. In addition, safety, tolerability and     anti-HIV effect of this regimen will also be studied. A total of 46 patients will be     enrolled.   "
232465|NCT00896064|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a     booster dose of pneumococcal vaccines (GSK 2189242A) in young adults.      This protocol posting deals with objectives & outcome measures of the booster phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT 00707798)   "
232466|NCT00896077|"     Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Autoimmune diseases happen when the     immune system does not identify part of the body as belonging to it. The immune system then     destroys that part as if it were an unknown tissue in the body. In T1DM, the body kills the     cells in the pancreas that produce insulin. Insulin is the hormone that unlocks the cells     of the body. It allows glucose to enter and fuel them. Special cells in the body called     islets make the insulin. Since glucose cannot enter the cells, it builds up in the blood. The     body's cells literally starve to death. Children are at risk of developing T1DM and the risk     is much higher than other severe, chronic childhood diseases. The only treatments are a     careful diet, planned physical activity, and testing blood sugar levels several times a day.     The patient must also inject insulin each day or use an insulin pump. There is no cure for     T1DM. Insulin injections are considered life support, because going without insulin for just     a few days causes the blood to have too much acid in it and that can lead to death. On the     other hand, taking too much insulin makes blood sugar levels go too low, and if untreated,     can lead to death as well.      DiaKine is developing Lisofylline to treat the failed immune system. This is what caused T1DM     in the first place and it does not go away. The purpose of this study is to see how safe the     study drug is. The study is also going to compare the levels of study drug in the blood and     to measure the effect of the study drug on other substances in the blood that are linked to     type 1 diabetes. These levels will be measured after the study drug is given as an injection     under the skin and an injection into the vein. To date, Lisofylline has been tested when     given as an injection in the vein.      The investigators hypothesize that Lisofylline will be safe when given as an injection under     the skin and in the vein and that levels of study drug will be very similar when given as an     injection under the skin and in the vein.      The investigators also hypothesize that Lisofylline will have a positive effect on the     substances in the blood that are linked to type 1 diabetes.   "
232472|NCT00896181|"     This phase II trial is studying whether giving a combination of docetaxel, cisplatin, and     fluorouracil chemotherapy followed by the combination of cisplatin with radiation therapy     works in treating patients with advanced nasopharyngeal cancer. Drugs used in chemotherapy,     such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy     uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a     high dose of radiation directly to the tumor may kill more tumor cells and cause less damage     to normal tissue. Giving combination chemotherapy together with radiation therapy may kill     more tumor cells.   "
232473|NCT00896194|"     This randomized clinical trial of weight loss treatment will examine if adding personalized,     one-on-one treatment session to standard behavioral group treatment will result in greater     weight loss, less weight regain after weight loss, and better adherence to the treatment     protocol.      Everyone who enrolls in the study will receive information on healthy eating, how to increase     their physical activity and develop healthy exercise habits and ways to change their eating     so that they will lose weight. This information will be provided at evening group sessions.     There will be a total of 20 group meetings over an 18-month period that will be held:        -  every week during the first month of the study,        -  every other week for the second month        -  once a month for months 3-12        -  every 6 weeks for months 13-18      Participants in the self-efficacy group will also be asked to participate in one-on-one     lifestyle counseling sessions with a study interventionist throughout the study.      Everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the     phone, and have blood tests done every six months (at the beginning of the study, at 6, 12,     and 18 months) a total of 4 times for the study.   "
232474|NCT00896207|"     This randomized early phase I trial is studying different formulations of SR13668 in healthy     volunteers. Giving SR13668 may help doctors learn more about how SR13668 is used by the body.     It is not yet known which formulation of SR13668 is most effectively used by the body.   "
232485|NCT00896350|"     RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in     tumor cells and may help in planning cancer treatment.      PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding     hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV     head and neck cancer.   "
232486|NCT00896363|"     The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The     safety and how well the body can handle the drug will also be investigated. The study will be     conducted in Russia in hospitalised patients with severe depression. GSK163090 will be     compared with placebo, which looks like the study drug but does not contain any active     substance. Subjects will be given either the study drug or the matching placebo.   "
232487|NCT00896376|"     RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients will respond to treatment.      PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women     with metastatic breast cancer.   "
232475|NCT00896220|"     Advances in critical care medicine have dramatically improved the survival of critically ill     patients requiring prolonged mechanical ventilation. However, there are no systematic     follow-up, rehabilitation, or psychoeducational interventions for these vulnerable patients     or their family caregivers who contribute to survivor recovery and rehabilitation. Major     barriers to developing these programs for survivors of prolonged mechanical ventilation and     their caregivers include the following:        1. There is inadequate information about the determinants of long-term functional outcomes          for a diverse group of survivors of prolonged mechanical ventilation.        2. There is inadequate information about the needs of survivors of prolonged mechanical          ventilation and their family caregivers across the trajectory of illness (i.e., from the          ICU to the community).        3. There is a poor understanding of the development of ICU-acquired muscle injury.      Towards RECOVER is the very first study to identify survivors of prolonged mechanical     ventilation who are at-risk for poor functional outcomes, to identify elements of the     care-giving situation that put caregivers at risk for poor quality of life and mental health,     to catalogue the rehabilitative needs of patients and family caregivers across the illness     trajectory, and to evaluate the mechanism of critical illness associated muscle injury.      The RECOVER Program consists of Four Phases:        -  Phase I: Towards RECOVER        -  Phase II: RECOVER development and pilot testing        -  Phase III: RECOVER randomized controlled trial        -  Phase IV: Long-term implementation of RECOVER   "
232476|NCT00896233|"     This study will assess the repeatability of Magnetic Resonance Elastography (MRE) in both     healthy volunteers and Hepatitis C Virus (HCV)-infected patients with fibrosis and lay the     groundwork for the validation of MRE as an alternative to liver biopsy.   "
232477|NCT00896246|"     This was a phase 1, open-label, randomized study, designed to assess the impact of Moviprep®     or Klean-Prep® on gastrointestinal transit. It was performed in two parallel groups with Part     A in two groups of four subjects preceding Part B, which was performed in two groups of 12     subjects. Subjects attended a pre-study medical within 28 days of dosing and a post-study     medical 5-10 days after the final dose. Within both Part A and Part B, subjects were required     to attend the clinical unit for 2 study periods. Part A consisted of a baseline period to     determine individual reference times for gastrointestinal transit. Part B was the test period     in which gastrointestinal transit following the administration of the test preparations was     assessed.   "
232478|NCT00896259|"     A group of orthopedic physiotherapists have developed a late phase program to educate and     instruct total hip replacement patients in progressive exercises appropriate for their level     of recovery. The components of this program include an educational presentation, individual     assessment and exercise prescription. The investigators' intent is to pilot the program using     a sample of patients. The objective of this pilot project:      To examine the effects of the late phase education session and home-based exercise program in     restoring hip muscle strength, gait and function   "
232479|NCT00896272|"     This study aims to understand the impact of living with Klinefelter syndrome (KS) and the     factors that contribute to adaptation in adolescents and adults. Individuals with KS may have     variable symptoms, including hypogonadism, gynecomastia, learning disabilities, and delay and     underdevelopment of secondary sexual characteristics. Perhaps the most challenging symptom of     KS is infertility, which seems to be a universal symptom. It is not fully understood how     males with KS conceptualize their condition, cope with their diagnosis, and adapt to living     with this condition. In this study, Lazarus and Folkman s Transactional Model of Stress and     Coping provides a framework for examining coping and adaptation in males with KS. A     cross-sectional research design using a quantitative survey will be utilized to examine the     relationships among appraisals (illness perceptions and perceived stigma), time elapsed since     learning of diagnosis, coping, and adaptation. Adolescents and adults with KS will be     recruited from national KS support networks via website postings, email listservs, and     printed newsletter postings. Adolescents will also be recruited from a private practice.     Participants will have the option to complete an online or paper version of the survey. The     main outcome variable is adaptation to living with a KS diagnosis.   "
232607|NCT00891475|"     The purpose of this study is to evaluate efficacy and safety of Radiofrequency ablation in     metastatic renal cell carcinoma patients with primary tumor less than 5 cm before medical     treatment. Ablation may allow for reduced morbidity and may increase the likelihood of     patients receiving systemic therapy.   "
232480|NCT00896285|"     Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid     with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming     back again, patients are given a medicine (talc) into the chest drain to seal up the space     around the lung. This procedure is known as pleurodesis. This sometimes causes pain and     discomfort, and the investigators do not know the best way of preventing this.      The investigators hope to find the best way to prevent pain during pleurodesis.   "
232481|NCT00896298|"     Lipodystrophies represent a therapeutic challenge with regards to insulin resistance,     hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue     loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects     with lipodystrophy.   "
232482|NCT00896311|"     Breech presentations (where a baby presents with feet or bottom down) have an increased risk     of perinatal and neonatal complications, and are usually delivered by cesarean section. As an     alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the     baby so that it is head down: this manoeuvre is called an external cephalic version (ECV).      Drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ECV success     rates. Nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested     as an agent to help ECV. There is some suggestion that nitroglycerin may be more helpful in     women who have not previously been pregnant (nulliparous women) than in women who have been     pregnant more than once (multiparous women), and so we have planned two trials.      This study is designed to answer the following questions for nulliparous women:      Will administration of IV nitroglycerin for uterine relaxation improve ECV success rates?     Will an increase in ECV success result in a decreased cesarean section rate?   "
232527|NCT00896935|"     RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to     test in the laboratory may help the study of cancer in the future.      PURPOSE: This research study is collecting and storing tumor, tissue, and blood samples from     patients with pancreatic cancer.   "
232488|NCT00896389|"     Although hypertension can be easily diagnosed and there are many medications available to     treat hypertension, this condition is poorly managed in many patients and is a leading cause     of morbidity and mortality worldwide. Because a newly identified hypertension susceptibility     gene, STK39 (Serine Threonine Kinase 39), plays a central role in kidney sodium transport,     the investigators propose a pharmacogenetics study to examine the relationships between STK39     genotypes and responses to salt loading and to thiazide diuretics, hydrochlorothiazide. The     investigators hypothesize that STK39 genotypes will be associated with the outcome of both     interventions and can contribute to personalized care for hypertension by predicting patients     most likely to effectively control their blood pressure by adopting salt-reducing diet and     taking thiazide diuretics.   "
232489|NCT00896402|"     Continuous femoral nerve block (CFNB) techniques continue to be increasingly used in the     management of postoperative pain after total knee arthroplasty. Although the risk of full     blown infection with CFNB has been poorly defined, the rate of catheter colonization after     antisepsis with povidone-iodine has been demonstrated to be high (Cuivillion et al. showed     the rate of colonization to be 57% after 48 hours). Recently, several anecdotal case reports     have demonstrated severe infectious complications including psoas abscess and necrotizing     fasciitis associated with continuous nerve block techniques. As the use of CFNB techniques     increase in popularity, infectious complications will undoubtedly become more common.      The American Society of Regional Anesthesia and Pain Medicine recommends the routine use of     antiseptic solutions with an alcohol base for skin disinfection before peripheral regional     techniques due to their penetration of the stratum corneum and their rapid and prolonged     effect. Chlorhexidine(chloraprep) has been proven to be better than povidone iodine solution     for skin preparation before epidural catheter and intravascular device insertion (Kinirons et     al., Ostrander et al., Mimoz et al.,). The goal of this prospective trial therefore is to     determine if an alcoholic solution of 0.5% chlorhexidine is more effective than an aqueous     solution of 10% povidone-iodine in reducing catheter colonization and reducing skin flora     associated with short term ( 48 hours) postoperative continuous femoral nerve catheter     placement. The investigators will also compare the ability of chloraprep and betadine     disinfection at the time of catheter placement to prevent bacterial contamination of the     continuous femoral catheter.   "
232535|NCT00897065|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how well patients respond to treatment.      PURPOSE: This laboratory study is looking at biomarkers that may predict response to     tamoxifen and letrozole in postmenopausal women with primary breast cancer treated on     clinical trial CAN-NCIC-MA17.   "
232490|NCT00896415|"     Maintaining strong muscles is important for the independence and quality of life in our older     population. Strong muscles provide mobility and reduce the chance of falls that lead to     injury. Many researchers are carrying out studies to examine different types of exercise and     drug treatments to prevent loss of muscle strength in older people. Often, these research     studies use x-ray computed tomography (CT) scans to measure the size and the amount of fat in     different muscles. These factors are known to reflect muscle health. Large studies can     involve many research subjects recruited at many different clinics with different CT     scanners. To ensure that these studies provide reliable results, the investigators must have     procedures to make sure that different CT scanners measure the same results for the same     amount of fat or muscle. The goal of our study is to develop these procedures. In this     project, the investigators will study women because they have the highest risk of bone     fractures resulting from falls. Thus, the subjects are being asked to volunteer for a study     where the subjects will be scanned on different scanners.   "
232491|NCT00896428|"     Severe asthma is a difficult to treat disease, characterized by bronchial remodelling, which     is an abnormal repair process that contributes to the development of poorly reversible airway     narrowing. Such remodelling is now considered as one of the main prognostic factors.     Gallopamil-sensitive calcium influx plays a key role in this remodelling process in vitro.     The objective of this study is to compare the effects of gallopamil versus placebo on the     bronchial smooth muscle remodelling in severe asthmatic patients.   "
232492|NCT00896441|"     The purpose of this study is to help us understand how depression changes brain activity and     how this relates to mood, anxiety, and cognitive functions like memory. We also hope to     develop a brain imaging test that will predict either before or within two weeks of starting     a medicine whether the treatment will work.   "
232493|NCT00896454|"     The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia     of Malignancy in patients with elevated serum calcium who do not respond to recent treatment     with intravenous bisphosphonates by lowering corrected serum calcium </= 11.5 mg/dL (2.9     millimoles /L) by day 10.   "
232494|NCT00896467|"     RATIONALE: Gathering information from patients who received treatment for metastatic cancer     while participating in a phase II or phase III randomized clinical trial and from patients     receiving standard treatment off-trial may help doctors learn more about the psychological     and emotional results of being in a clinical trial.      PURPOSE: This clinical trial is comparing the psychological and emotional impact of     participating in a randomized clinical trial with the impact of standard treatment in     patients with metastatic cancer.   "
232495|NCT00896480|"     The clinical objective of this clinical trial is to examine the clinical activity in terms of     tumor response and time to treatment failure of the immunotherapeutic product GSK2132231A     when given to patients with unresectable and progressive metastatic cutaneous melanoma. The     safety of the treatment will also be assessed just as its immunogenicity in terms of the     humoral and cellular immune response induced by the GSK2132231A immunotherapeutic.     Translational research objectives are to assess the effects of the study treatment in terms     of various biological variables.   "
232496|NCT00896493|"     Non-myeloablative approach for allogeneic transplant is a reasonable option, especially given     that the median age at diagnosis is 55-60 years and frequently present compromised skin in     these patients, which increases the risk of infection. Therefore, we propose a clinical study     with allogeneic HSCT using a unique non-myeloablative preparative regimen, TLI/ATG, to treat     advanced MF/SS.   "
234421|NCT00916058|"     The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDA™),     in combination with Melphalan in subjects with multiple myeloma who are undergoing an     Autologous Stem Cell Transplant.   "
232497|NCT00896519|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Colony-stimulating factors, such as GM-CSF, may cause the body to make     more blood cells and help it recover from the side effects of rituximab and combination     chemotherapy.      PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab and     combination chemotherapy works in treating patients with previously untreated advanced     follicular non-Hodgkin lymphoma.   "
232498|NCT00896532|"     The primary objective was to determine the effect of treatment with romosozumab versus     placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the     lumbar spine in postmenopausal women with low bone density.   "
232499|NCT00896545|"     You are invited to participate in a research study to understand more about childhood obesity     and how to prevent it. We hope to learn how families influence each others eating habits.   "
232500|NCT00896558|"     This study will be the first repeat dose administration of GSK1322322 to investigate safety,     tolerability, and pharmacokinetics in healthy subjects as well as elderly volunteer subjects.     The study will also include a P450 probe drug (midazolam) to evaluate the effect of     GSK1322322 to inhibit or induce CYP3A4 substrates.   "
232501|NCT00896571|"     The aim of the present study is to investigate the effects of the transdermal patch on the     endometrium in healthy women who require contraception.   "
232502|NCT00896584|"     Some patients with chronic obstructive pulmonary disease (COPD) need supplementary oxygen     during air travel. Guidelines issued by The British Thoracic Society (BTS) for pre-flight     evaluation do not discriminate sufficiently between those who need supplementary oxygen     during flight, and those who can do without. Previous studies have indicated that decreasing     hemoglobin oxygen saturation during exercise may predict in-flight hypoxemia. The objective     of the present study is to examine if adding exercise oxygen desaturation to the BTS     algorithm will better predict requirements for in-flight supplementary oxygen.   "
232536|NCT00897078|"     RATIONALE: Gathering information about metabolic syndrome from young patients who have     survived acute lymphoblastic leukemia (ALL) may help doctors learn more about the disease.      PURPOSE: This phase I trial is studying the metabolic syndrome in young patients who have     survived acute lymphoblastic leukemia and in healthy sibling volunteers.   "
232606|NCT00891462|"     The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium     bromide doses as compared to placebo in the treatment of moderate to severe chronic     obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period,     12-week double-blind treatment, and 2-week follow-up phone visit.   "
232503|NCT00896597|"     This is an open, randomized study in patients with different severity stages of hepatic     cirrhosis, in which rater pairs will be used for the assessment of the intra- and inter-rater     reproducibility of NRL972 pharmacokinetics and CTP sum score. Rating will be performed by 32     to 40 pairs of raters. The raters will perform the required assessments in the capacity of     sub-investigators of the phase I (co-ordinating) unit.      Up to 240 patients with clinically established hepatic cirrhosis without confounding     end-stage co-morbidity (stable disease) will be studied. Within 30 days of confirmation of     eligibility, Visit 1 will take place to determine the investigational parameters (NRL972     pharmacokinetics, clinical laboratory tests, and determination of CTP sum score). At     approximate intervals of one week, Visits 2, 3 and 4 will occur, and the investigational     parameters will again be assessed.   "
232504|NCT00896610|"     Background:        -  Diabetes is a disease defined by abnormally high blood sugar (glucose) levels. Glucose          is an essential source of energy for the body s cells, but insulin is required to move          the glucose into the cells. Insulin is a hormone produced by the pancreas that allows          glucose to enter cells.        -  In diabetes, the body is unable to supply enough insulin to meet its demands. The          problem may be a low supply of insulin or a high demand for insulin. Someone who has          been diagnosed with diabetes has lost much of their insulin-producing capacity. Clinical          studies have shown that good control of blood sugar is essential to prevent diabetes          complications like damage to the eyes, kidneys, nerves, and blood vessels.      Objectives:        -  To establish a relationship with several individuals with diabetes caused by the immune          system attacking the body s insulin-producing cells in order to:        -  Explore why the immune system attacks insulin-producing cells.        -  Understand why some individuals develop diabetes-related complications and others do          not.        -  Develop therapies to improve how patients can control their blood sugar levels.        -  Continue to follow subjects who have completed or are considering other NIH          diabetes-related studies.        -  To develop improved tests for determining an individual s risk for developing diabetes          and/or to accurately diagnose the exact type of diabetes.      Eligibility:        -  Individuals who have been diagnosed with or are at risk for developing diabetes.      Design:        -  Standard physical examination and clinical tests to determine if the patient has          diabetes or to confirm a particular type of diabetes:        -  None of the treatment in this study is experimental.        -  Patients will receive a separate consent form for any special tests needed to learn more          about their particular type of diabetes.        -  Patients may be asked to provide additional urine and blood samples for use in          laboratory research about diabetes.        -  Researchers may offer medical treatment advice for diabetes, or explain how to improve          patients diabetes management skills.   "
232505|NCT00896623|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict a patient's response to treatment.      PURPOSE: This laboratory study is looking at DNA in tissue samples from women with breast     cancer to see if it can predict treatment outcome.   "
232506|NCT00896636|"     RATIONALE: Studying samples of blood and breast tissue from healthy women in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to breast cancer risk.      PURPOSE: This research study is looking at breast tissue in women not previously diagnosed     with breast cancer who are undergoing fine-needle aspiration.   "
232507|NCT00896649|"     RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment     for breast cancer. It is not yet known whether positron emission mammography is more     effective than standard mammography in finding breast tumors.      PURPOSE: This phase III trial is studying positron emission mammography to see how well it     works compared with standard mammography in women undergoing screening mammogram at Boston     Medical Center.   "
232508|NCT00896662|"     RATIONALE: Studying the dendritic cells in samples of blood from patients with cancer     receiving aflibercept may help doctors learn about the effect of aflibercept on dendritic     cells.      PURPOSE: This laboratory study is evaluating dendritic cells in patients with advanced solid     tumors or non-Hodgkin lymphoma receiving aflibercept on clinical trial VGFT-ST-0202.   "
232509|NCT00896675|"     RATIONALE: Studying samples of blood in the laboratory may help doctors learn more about     cancer. It may also help doctors predict how well patients will respond to treatment.      PURPOSE: This research study is looking at proteins in blood samples to predict treatment     benefit in patients with recurrent and/or metastatic squamous cell head and neck cancer.   "
232510|NCT00896688|"     The diagnostic cervical branch block for neck pain due to cervical facet joint pain has been     traditionally done under fluoroscopic guidance. Its diagnostic value and technique have been     well established. However, recently some studies have shown that the diagnostic cervical and     lumbar medial branch block can be done under ultrasound guidance.   "
232511|NCT00896701|"     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the     laboratory may help doctors predict response in patients previously treated with     interleukin-2.      PURPOSE: This laboratory study is looking at the relationship between natural killer cells'     ability to kill leukemia cells and the outcome of patients with acute myeloid leukemia     previously treated with interleukin-2.   "
232512|NCT00896714|"     The main objective of the study is to analyze the influence of several environmental (i.e.,     timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle)     on anesthetic drug requirements (hypnotic and opiate).   "
232513|NCT00896727|"     RATIONALE: Studying the proteins expressed in tumor tissue samples in the laboratory from     patients with cancer may help doctors learn more about biomarkers related to cancer. It may     also help doctors predict how patients respond to treatment.      PURPOSE: This laboratory study is looking at protein expression in predicting response to     treatment using tumor tissue samples from women with stage I, stage II, or stage IIIA breast     cancer treated on clinical trial SWOG-9313.   "
232514|NCT00896740|"     RATIONALE: Studying samples of bone marrow from patients with Fanconi anemia and from healthy     participants in the laboratory may help doctors learn more about changes that occur in DNA     and identify biomarkers related to Fanconi anemia.      PURPOSE: This laboratory study is evaluating gene function in bone marrow cells from patients     with Fanconi anemia and from healthy participants.   "
232515|NCT00896753|"     RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer may     help doctors identify biomarkers related to cancer.      PURPOSE: This laboratory study is using gene expression profiling to evaluate normal tissue     and tumor tissue from patients with colon cancer that has spread to the liver, lungs, or     peritoneum.   "
232516|NCT00896766|"     RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer     to study in the laboratory may help doctors learn more about changes that may occur in DNA     and identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking at lymphoblasts in young patients with high-risk     acute lymphoblastic leukemia.   "
232517|NCT00896779|"     Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase     III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in     improved visual function in such patients.Since ranibizumab has been shown to be the most     effective therapy for exudative macular degeneration we propose to treat all patients in this     study with monthly ranibizumab intravitreal injections.      Patients will be assigned to one of two groups by the flip of a coin. Group #1 for heads     and Group #2 for tails.      Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then     as needed therapy.      Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as     needed therapy.   "
232518|NCT00896792|"     RATIONALE: Gathering information about patients with terminal metastatic cancer may help     doctors learn more about the effectiveness of a nurse practitioner hospice program. It is not     yet known whether a nurse practitioner program helps increase patients' length of stay in     hospice.      PURPOSE: This randomized research study is evaluating a nurse practitioner hospice program     for patients with terminal metastatic cancer and their families or caregivers.   "
232519|NCT00896818|"     RATIONALE: Studying samples of blood, urine, and tumor tissue in the laboratory from patients     with cancer and their female relatives and friends may help doctors learn more about changes     that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is looking at genes and other risk factors for second primary     breast cancer in women with breast cancer and in their female family members and friends.   "
232520|NCT00896831|"     The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the     management of hepatic encephalopathy.   "
232521|NCT00896844|"     This is a randomized, controlled trial on the effect of emotional disclosure of traumatic     life events on physical health. The hypothesis is that expression of emotions could possibly     improve physical health.   "
232522|NCT00896857|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This laboratory study is evaluating cells collected through ductal lavage in women     undergoing surgery for ductal carcinoma in situ or other breast cancer.   "
232523|NCT00896883|"     The purpose of this study is to determine the functional performance of the Middle Turbinate     Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in     which the Principal Investigator determines clinical relevance.   "
232524|NCT00896896|"     RATIONALE: Studying samples of blood in the laboratory may help doctors predict which     patients will develop hypersensitivity to cetuximab.      PURPOSE: This research study is looking at hypersensitivity to cetuximab in patients with     head and neck cancer or advanced colorectal cancer previously treated with cetuximab.   "
232525|NCT00896909|"     RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the     laboratory may help doctors learn more about changes that may occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients     with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial     ECOG-2598.   "
232526|NCT00896922|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer. It may also help doctors     predict how patients respond to treatment.      PURPOSE: This laboratory study is examining biological markers in patients with follicular     lymphoma treated on clinical trial SWOG-8809, SWOG-9800, or SWOG-9911.   "
232531|NCT00896987|"     The purpose of this study is to compare the effect of anti-epileptic drugs' (AEDs) long-term     treatment on cognitive function. This study is an open-label, randomized, multicenter     comparative trial of lamotrigine versus carbamazepine. The planned enrollment is 100     patients.   "
232532|NCT00897026|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors plan the best treatment.      PURPOSE: This research study is looking at tissue samples from women who underwent     chemotherapy for lymph node-positive stage II or stage IIIA breast cancer.   "
232533|NCT00897039|"     RATIONALE: Collecting samples of tissue from patients with cancer to study in the laboratory     may help doctors predict how well patients will respond to treatment with certain     chemotherapy drugs and plan the best treatment.      PURPOSE: This laboratory study is looking at tumor tissue samples to predict response to     chemotherapy in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal     cancer.   "
232534|NCT00897052|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict survival of patients with head and neck cancer.      PURPOSE: This laboratory study is assessing gene expression profiles in predicting survival     of patients with head and neck cancer.   "
232572|NCT00897611|"     RATIONALE: Studying levels of tumor DNA in the samples of blood from patients with cancer may     help doctors find out whether the cancer has grown and how much.      PURPOSE: This laboratory study is comparing levels of tumor DNA with MRI and CT scan findings     to measure cancer growth in patients with grade III or grade IV malignant glioma.   "
232537|NCT00897091|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This laboratory study is looking at biomarkers in predicting outcome in     postmenopausal women with hormone receptor-positive, node-positive breast cancer treated with     tamoxifen with or without cyclophosphamide, doxorubicin, and fluorouracil.   "
232538|NCT00897104|"     A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for     the acute treatment of a migraine attack.   "
232539|NCT00897117|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that may occur in RNA and identify biomarkers related     to cancer.      PURPOSE: This research study is collecting and analyzing lung tissue samples from patients     undergoing surgery for non-small cell lung cancer.   "
232540|NCT00897130|"     Azacitidine will be given at a dose of 75 mg/sqm (s.c) daily for 5 consecutive days every 28     days (every month) for a total of 8 courses to low risk MDSs according to IPSS scoring     system. In fact, several studies produced high rates of trilineage responses, reduces the     risk of progression to acute myeloid leukemia (AML) in high-risk MDS and improves the quality     of life (QoL). The use of 5-Aza in the earlier phases of MDS could reduce the proliferative     advantage of MDS clone and favour the regrowth of normal hematopoiesis.   "
232541|NCT00897143|"     RATIONALE: Studying samples of pleural fluid in the laboratory from patients with lung cancer     may help doctors identify early lung cancer cells. It may also help the study of lung cancer     in the future.      PURPOSE: This laboratory study is looking at malignant pleural effusion samples from patients     with primary lung cancer to see if early lung cancer cells can be identified.   "
232542|NCT00897169|"     This trial is conducted in Europe and Japan. The aim of this clinical trial is to investigate     the possible difference in the development of type 2 diabetes in a Japanese and a Caucasian     population. Healthy subjects, subjects with impaired glucose tolerance, as well as subjects     with type 2 diabetes will be included in the trial. The development of type 2 diabetes across     the cohort will be investigated with regard to insulin sensitivity and B-cell capacity.   "
232543|NCT00897182|"     RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with     cancer may help doctors learn more about changes that occur in DNA and identify genes related     to cancer. It may also help doctors diagnose cancer and predict how patients will respond to     treatment.      PURPOSE: This research study is identifying cancer-related genes in blood and/or bone marrow     samples from patients with acute myeloid leukemia.   "
232544|NCT00897208|"     RATIONALE: Studying samples of nipple fluid, urine, and blood in the laboratory from patients     with cancer and from patients at risk of developing cancer may help doctors identify and     learn more about biomarkers related to cancer. It may also help doctors learn more about     breast cancer and identify patients at risk of developing breast cancer.      PURPOSE: This laboratory study is looking at biomarkers in nipple fluid, urine, and blood     samples from women with newly diagnosed ductal carcinoma in situ or stage I or stage II     breast cancer and in women at risk of developing breast cancer.   "
232545|NCT00897221|"     The primary objective of this study is to evaluate the long-term safety and tolerability of     deferiprone in subjects with Friedreich's ataxia (FRDA).      The secondary objective is to evaluate the long-term efficacy of deferiprone for the     treatment of FRDA.      The tertiary objectives are to evaluate the effect of deferiprone on:        1. cardiac function,        2. quality of life, and        3. functional status.   "
232546|NCT00897234|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is looking at blood samples from patients with non-small cell     lung cancer and from healthy volunteers.   "
232547|NCT00897247|"     RATIONALE: Studying samples of body fluid and blood from patients who have been exposed to     asbestos or vermiculite in the laboratory may help doctors learn more about changes that may     occur in DNA and identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking for biomarkers to detect mesothelioma early in     patients exposed to asbestos or vermiculite.   "
232548|NCT00897260|"     To determine the time to and rate of hematologic engraftment following unrelated umbilical     cord blood transplantation in adults with one or two cord blood units using total body     irradiation and fludarabine as the transplant conditioning regimen and cyclosporine/MMF as     graft-versus-host disease prophylaxis.   "
232549|NCT00897273|"     RATIONALE: Gathering information about human papillomavirus infection of the mouth in young     men may help doctors learn more about risk factors for oropharyngeal cancer.      PURPOSE: This research study is assessing human papillomavirus infection of the mouth in     young men and risk factors for oropharyngeal cancer.   "
232550|NCT00897286|"     This laboratory study is looking at stored tumor samples in young patients with brain tumors.     Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors     learn more about changes that occur in DNA and identify biomarkers related to cancer.   "
232551|NCT00897299|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict whether cancer will come back after treatment.      PURPOSE: This laboratory study is identifying genes that may help predict recurrence in women     with breast cancer treated with chemotherapy.   "
232552|NCT00897312|"     RATIONALE: Studying samples of blood from patients with cancer, hepatitis C, or Crohn disease     in the laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer and other diseases.      PURPOSE: This laboratory study is looking at the effect of biological therapy on biomarkers     in patients with untreated hepatitis C, metastatic melanoma, or Crohn disease.   "
232553|NCT00897325|"     This research study is collecting and storing samples of bone marrow and blood from patients     with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma. Collecting and     storing samples of bone marrow and blood from patients with cancer to study in the laboratory     may help doctors learn more about cancer and help predict the recurrence of cancer.   "
232554|NCT00897338|"     RATIONALE: Studying samples of blood and pleural or peritoneal fluid from patients with     metastatic breast cancer in the laboratory may help doctors identify biomarkers related to     breast cancer and learn more about how breast cancer begins and spreads in the body.      PURPOSE: This research study is looking at a new way of identifying circulating breast cancer     cells in blood and in pleural or peritoneal fluid in women with metastatic breast cancer.   "
232555|NCT00897351|"     RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with     cancer may help doctors learn more about changes that occur in DNA and identify biomarkers     related to cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at tissue and blood samples from patients with     recurrent prostate cancer who received lapatinib on clinical trial ECOG-E5803.   "
232557|NCT00897377|"     Although the prognosis of patients with low-grade glioma (LGG) is generally good, recurrence     seems unavoidable in some patients because of the infiltrative growth of the tumors. How to     treat LGGs is still under controversy. The role of radiation therapy and chemotherapy in the     treatment of LGG need to be further investigated. The purpose of this study is the following:        1. to investigate the role of early radiation therapy in MRI-determined total resected          LGGs;        2. to compare the efficacy of early radiation therapy and that of initial chemotherapy in          the LGGs without total resection.   "
232558|NCT00897390|"     To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage)     immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet     and 1000 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed     state.   "
232559|NCT00897403|"     RATIONALE: Collecting and storing samples of blood and tissue from patients undergoing     colonoscopy to study in the laboratory may help doctors learn more about colon cancer and     identify biomarkers related to colon cancer in the future.      PURPOSE: This laboratory study is collecting blood and tissue samples for future colon cancer     biomarker studies in patients undergoing colonoscopy.   "
232560|NCT00897416|"     RATIONALE: Collecting and storing samples of blood and studying them in the laboratory may     help doctors learn more about changes that may occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This laboratory study is examining biomarkers in women with a high risk or average     risk of breast cancer.   "
232561|NCT00897429|"     This research trial studies tissue samples from patients with stage II colon cancer treated     on Cancer and Leukemia Group B (CALGB)-9581 or CALGB-90903. Studying samples of tissue from     patients with cancer in the laboratory may help doctors learn more about changes that occur     in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help     doctors understand how patients respond to treatment.   "
232562|NCT00897442|"     This laboratory study is collecting tumor tissue and blood samples from patients with     gynecologic tumors. Collecting and storing samples of tumor tissue and blood from patients     with cancer to study in the laboratory may help in the study of cancer.   "
232563|NCT00897455|"     RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation     carriers may help doctors learn more about cancer and identify biomarkers related to cancer.      PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2     mutation carriers.   "
232564|NCT00897468|"     RATIONALE: Changing the genes in laboratory mice to create a living model of human breast     cancer may help doctors learn more about breast cancer.      PURPOSE: This research study is developing mouse models of breast cancer using tissue samples     that were previously collected from women with breast cancer.   "
232565|NCT00897481|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help the study of cancer in the future.      PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma     who have undergone sentinel lymph node biopsy.   "
232566|NCT00897494|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that may occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This laboratory study is examining blood samples from patients with cancer to     identify biomarkers that may help in the early detection of pancreatic cancer.   "
232567|NCT00897507|"     RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will     respond to treatment      PURPOSE: This laboratory study is looking at DNA in tumor tissue samples from young patients     with acute lymphoblastic leukemia.   "
232568|NCT00897520|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors identify biomarkers related to cancer and predict how patients will respond to     treatment.      PURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma     receiving high-dose interferon therapy.   "
232569|NCT00897533|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients respond to treatment with erlotinib.      PURPOSE: This laboratory study is developing a model to predict progression-free survival     after erlotinib in patients with non-small cell lung cancer.   "
232570|NCT00897546|"     RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the     laboratory may help doctors learn more about changes that may occur in DNA and identify     biomarkers related to cancer, and may help doctors learn how well patients will respond to     treatment.      PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon     therapy in patients with melanoma.   "
232571|NCT00897559|"     RATIONALE: Studying the genes expressed in samples of bone marrow from patients with cancer     may help doctors identify biomarkers related to cancer.      PURPOSE: This research study is looking at bone marrow samples from patients with acute     leukemia.   "
232575|NCT00897650|"     RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with     cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA)     and may also identify protein expression patterns related to cancer. It may also help doctors     predict how patients will respond to treatment.      PURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of     predicting response to treatment in patients with lung cancer.   "
232576|NCT00897663|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer. It may also help doctors     predict how patients will respond to treatment.      PURPOSE: This laboratory study is looking at tissue samples from patients with glioblastoma     multiforme to identify biomarkers that may improve the selection of patients for epidermal     growth factor receptor inhibitor therapies.   "
232577|NCT00897676|"     The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood     glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism. Funding     Source - FDA Office of Orphan Products Development (OODP).   "
232578|NCT00897702|"     The purpose of this study is to learn why certain drugs stop working in patients.In lab     studies, tumors become resistant in several ways. Specific molecules seem to change and this     may be why therapy stops working. However, we do not know if the same molecules change in     patients. This study is being done to see if they do change. If we learn more about how     patients become resistant, we may be able to offer better treatment in the future.   "
232579|NCT00897715|"     There has been an exponential growth in the number of people with Chronic Kidney Disease     (CKD) needing dialysis or transplantation, increasing from 209,000 in 1991 to 472,000 in     2004. This is highly concerning due to both the human cost and the burden that it represents     to the health care system. Recent comparison of the NHANES surveys showed that CKD prevalence     increased from 10% in 1988-1994 to 13% in 1999-2004. Patients with CKD are more likely to die     from premature cardiovascular death than to reach ESRD. In those that reach ESRD,     cardiovascular disease (CVD) accounts for over half of the deaths in dialysis. The prevalence     of CKD for the VA population is 20%, and 31.6% for diabetics, higher than in the general     population. These observations emphasize the need of risk stratification, early detection,     and prevention efforts with respect to CKD progression and the CVD burden that afflicts CKD     through targeted interventions in high-risk groups (personalized medicine).      CKD is multifactorial, however familial aggregation of end-stage renal disease (ESRD) and CKD     have been reported for all types of nephropathy underscoring kidney disease genetic     susceptibility . Genetic predisposition to ESRD is stronger in African Africans. African     Americans with a first-degree relative with ESRD have a 9-fold increase risk of ESRD vs. a     3-5 fold increase in whites.      Studies consistently show that CKD is an inflammatory process and that biomarkers of     inflammation increase since early stages of CKD. CVD is also an inflammatory process, and     genes that affect inflammation are associated with higher risk of CVD. Since inflammation is     a common denominator of both disease processes (CKD and CVD), it is likely that genes that     govern inflammation may be involved in both, the predisposition to CKD and the burden of CVD     attributable to CKD. Additionally if inflammation plays a central role in the burden of CVD     in CKD than drugs that modulate inflammation should impact both: CKD progression and     non-traditional CV risk factors and CVD.      The overall goal of this proposal is to study genetic predisposition to CKD, and CVD risk in     CKD through inflammatory pathways, and the effect that a potent anti-inflammatory     intervention like interleukin 1 receptor antagonist (IL-1ra), will have in inflame patients     with CKD stages 3&4. Specific Aims: 1) To determine if specific polymorphism/haplotypes,     genotype combinations and gene-environmental interactions that can affect inflammation,     available from the Third National Health and Nutrition Examination Survey (DNA data set),     specifically in the CRP,IL-1, IL-10 and TNF- genes, are associated with CKD. 2) To determine     if the specific polymorphisms and haplotypes studied in Aim 1 are associated with faster CKD     progression and CV outcomes in a longitudinal cohort from the African American Study of     Kidney Disease. 3)To determine if a targeted anti-inflammatory intervention, an IL-1 receptor     antagonist, will modulate systemic inflammation, endothelial function, oxidative stress and     urinary cytokines, the proposed surrogate markers of CVD and CKD progression in inflame     patients with CKD stages 3&4.   "
232580|NCT00897728|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study is looking at tumor and blood samples from women with breast     cancer.   "
232581|NCT00897741|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that may occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This laboratory study uses gene expression profiling to compare primary tumor cells     with metastatic tumor cells in patients with metastatic pancreatic cancer.   "
232582|NCT00897754|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors understand how patients respond to treatment.      PURPOSE: This laboratory study is looking at gene expression in patients with advanced or     metastatic colorectal cancer receiving bevacizumab.   "
232583|NCT00897767|"     RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer     to study in the laboratory may help doctors learn more about diagnosing cancer and determine     a patient's eligibility for a treatment clinical trial. It may also help the study of cancer     in the future.      PURPOSE: This laboratory study is collecting tissue samples from patients with leukemia or     other blood disorders who are planning to enroll in an ECOG leukemia treatment clinical     trial.   "
232584|NCT00897780|"     The objective of the study is to examine the effect of combined treatments (biofeedback with     virtual reality) for pediatric chronic headache.   "
232585|NCT00897793|"     RATIONALE: Measuring levels of transforming growth factor-beta (TGF-beta) in the blood of     patients with epithelial cancers (head and neck, lung, breast, colorectal, and prostate) may     help doctors predict how patients will respond to treatment with radiation therapy.      PURPOSE: This research study is measuring levels of TGF-beta in patients with epithelial     cancers who are undergoing radiation therapy.   "
232586|NCT00897806|"     RATIONALE: DNA analysis of tumor tissue from patients with cancer may help doctors predict     how patients respond to treatment and plan the best treatment.      PURPOSE: This laboratory study is identifying genetic markers that predict response to     paclitaxel in patients with newly diagnosed stage III or stage IV ovarian epithelial cancer     or primary peritoneal cancer.   "
232587|NCT00897819|"     RATIONALE: Studying samples of blood, urine, and tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients respond to     treatment.      PURPOSE: This laboratory study is analyzing the DNA in tissue samples from patients with     advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without     bevacizumab on clinical trial E-3200.   "
232588|NCT00897832|"     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This laboratory study is looking at biomarkers in predicting response to treatment     in patients who have undergone surgery for pancreatic cancer.   "
232589|NCT00897845|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is looking at tumor samples from women who have undergone     chemotherapy for breast cancer.   "
232590|NCT00897858|"     RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer in the     laboratory may help doctors identify biomarkers related to cancer.      PURPOSE: This laboratory study is studying cerebrospinal fluid proteins and angiogenesis     proteins in young patients with newly diagnosed central nervous system tumors.   "
232591|NCT00897871|"     RATIONALE: Studying samples of blood in the laboratory from young patients with cancer may     help doctors learn how carboplatin, cyclophosphamide, and etoposide affect the body and how     patients will respond to treatment.      PURPOSE: This laboratory study is evaluating the side effects and how well anticancer drugs     work in very young patients with cancer.   "
232592|NCT00897884|"     The study will be testing metformin in patients with breast cancer who are about to undergo     surgery. Patients will take metformin 3 times daily for about 2-3 weeks prior to their     surgery date. It is hypothesized that metformin will reduce cell proliferation rates in     tumour tissue.   "
232608|NCT00891488|"     The purpose of this study is to test the hypothesis that physiological adaptations to regular     exercise training (i.e. physical fitness) attenuates age-related decline in stress resilience     to both oxidative stress and the neuroendocrine responses to psychosocial stress.   "
232593|NCT00897897|"     This study is to confirm the safety and technical effectiveness of MRI guided High Intensity     Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas.     The importance of this therapy is that it offers a non-invasive, uterine sparing procedure     for the treatment of uterine fibroids in pre- and peri- menopausal women.      MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate     fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the     fibroid tissue. The goal of the study is to show treatment safety and technical     effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion     criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study     patients.      The goal of this study is to demonstrate that:        1. The safety profile is acceptable (safety)        2. Actual MR-HIFU ablated volumes (as measured with contrast enhanced MRI) match the          intended volumes (technical effectiveness)        3. When intended, volumes greater than 20% of the fibroid volume can be successfully          ablated (technical effectiveness)      The investigators' hypothesis is that greater than 70% of fibroids will have concordance     between intended lesion volume and actual lesion volume while maintaining an acceptable     safety profile.   "
232594|NCT00897910|"     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the     laboratory may help doctors learn more about T cells and plan better treatment for multiple     myeloma.      PURPOSE: This research study is looking at T cells in blood and bone marrow samples from     patients with multiple myeloma.   "
232595|NCT00897923|"     RATIONALE: Measuring the number of radiolabeled white blood cells in non-Hodgkin's lymphoma     tumors may help doctors predict how well patients will respond to treatment, and may help the     study of cancer in the future.      PURPOSE: This study is measuring radiolabeled white blood cells in patients with     non-Hodgkin's lymphoma.   "
232596|NCT00897936|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how well patients respond to treatment.      PURPOSE: This laboratory study is looking at tissue samples from patients with acute myeloid     leukemia.   "
232597|NCT00897949|"     A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine     attack and treatment of up to two headache recurrences compared to placebo.      The long term extension study which pools patients from MK0462-022, -025, and -029 is     described in NCT01286207.   "
232598|NCT00897962|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur and identify biomarkers related to cancer.      PURPOSE: This research study is looking at blood glycan biomarkers in women with stage IV     breast cancer.   "
232599|NCT00897975|"     Red yeast rice may be useful to lower cholesterol, especially in a population of patients who     cannot tolerate traditional therapy with statins.      The addition of an over-the-counter phytosterol to red yeast rice may offer additional lipid     lowering benefits when compared to red yeast rice alone.      These supplements will be given to all participants. Up to one-half will enroll in a     lifestyle intervention program called Change of Heart and will be compared to patients who do     not participate in the program. The study will last one year.   "
232600|NCT00897988|"     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This laboratory study is looking at the DNA in tumor tissue samples from patients     with human papilloma virus-associated cancer of the oropharynx.   "
232601|NCT00898014|"     RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help     doctors predict how patients will respond to treatment.      PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting     response in patients receiving first-line chemotherapy for stage IV breast cancer.   "
232602|NCT00891397|"     The purpose of this study is to assess the efficacy of pregabalin in patients with complex     regional pain syndrome Type I and to determine whether it provides clinically significant     pain relief and whether it improves functioning of the upper limb.   "
232623|NCT00891683|"     Two Phase 1 studies have been conducted with AEG33773 and available safety and tolerability     data from these studies support further clinical development of AEG33773. The current study     is proposed as a proof-of-concept study to assess the potential analgesic efficacy of     AEG33773 to reduce pain associated with chronic Diabetic Peripheral Neuropathy.   "
232643|NCT00898261|"     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer     may help doctors identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking at gene expression in tissue from patients with     acute lymphoblastic leukemia enrolled in clinical trial ECOG-2993.   "
232603|NCT00891423|"     Meropenem is a powerful antibiotic used in intensive care for people who have very serious     infections. Meropenem is rapidly removed from the blood by the kidneys and it is very     expensive. In very ill patients in intensive care, it is uncertain how best to give this     antibiotic. Studies have suggested that a smaller dose given over a longer period of time,     results in blood levels of meropenem that are just as good as when a higher dose is given     over a shorter period of time. This direct comparison has not been tested in intensive care     patients. It is important to know this because if giving a lesser amount more slowly is just     as good, then doctors will choose to give meropenem this way. To establish whether this is     the case, the investigators plan to conduct an initial (pilot) study in ten intensive care     patients at Austin hospital.      Adult (age 18 years or older) patients in intensive care who have a serious infection being     treated with the antibiotic, meropenem for three days or more will be able to participate in     this study. The decision to start meropenem will be made by the intensive care doctors and     they will give it in the usual way for 24 hours.      The investigators will then in a random way (like tossing of a coin), give the participant     meropenem either in the usual way (1 gram infused over 30 minutes) or give them a smaller     amount, but over a longer period of time (500 milligrams infused over 3 hours). This will be     done for 24 hours. They will then receive meropenem in the alternative way for another 24     hours. After this time the intensive care doctors will decide how meropenem will continue to     be given.      Blood levels of meropenem will be measured to see if they are the same when meropenem is     given in each of the two different ways. During each different way of giving meropenem, 7     blood samples will need to be taken. Ten mls (or one spoonful) of blood will be required for     each measurement. Blood levels will be taken through monitoring lines, which will be already     present.      Other information will also be collected about the participant during this study. This will     include their age, gender, height, weight, information about what other medical conditions     they have and measurements of how well their kidneys are functioning.   "
232604|NCT00891436|"     Rationale and objectives:      Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when     used for the treatment of seasonal allergic rhinitis during the ragweed pollen season.     Although this is the only published report of an intranasal corticosteroid shown to     effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the     tears of patients with allergic conjunctivitis are known to have increased concentrations of     cytokines and allergic mediators.      The objective of this study is to determine if the positive effects of Veramyst nasal spray     on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators     will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray     decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst     nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the     amount of allergic mediators detected in their tears.   "
232609|NCT00891501|"     This study is conducted to assess whether implanting autologous, culture-expanded,     mesenchymal stem cells obtained from the bone marrow of patients with early osteoarthritis,     cartilage defects or cartilage and underlying bone and cartilage (osteochondral) defects in     joints is effective in the treatment of such conditions and alleviation of patients symptoms.   "
232610|NCT00891514|"     The purpose of this study is to examine the effects of treadmill training on inflammation in     the skeletal muscle and adipose tissue, insulin action in the skeletal muscle, and whole body     glucose metabolism in stroke survivors. The fundamental hypothesis of this study is that key     inflammatory markers in adipose tissue and skeletal muscle are abnormal, skeletal muscle     insulin signaling is impaired, and systemic insulin sensitivity is reduced in hemiparetic     stroke patients and that these factors are modifiable and improved by exercise training in     stroke patients.   "
232611|NCT00891527|"     The objective of this study is to conduct a pilot study using biologic agents Avastin and     Gleevec to treat progression of multivessel intraluminal pulmonary vein stenosis in children.   "
232612|NCT00891540|"     The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 %     versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section.      The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid     consumption.   "
232613|NCT00891553|"     The purpose of this study is to determine whether bone mineral density has increased in a     subgroup of postmenopausal osteoporotic women from study CR9108963, between 6 and 12 months     following cessation of ronacaleret therapy.   "
232614|NCT00891566|"     The purpose of this study is to determine whether the immobilization period is helpful for     the better healing of repaired rotator cuff.      The investigators hypothesis is that the longer immobilization after rotator cuff repair will     help the healing of rotator cuff.   "
232615|NCT00891579|"     This study is a prospective trial of Alimta (pemetrexed) versus IRESSA (gefitinib) among     epidermal growth factor receptor wild-type Non-Small Cell Lung Cancer (NSCLC) patients in a     2nd line setting.   "
232616|NCT00891592|"     This protocol will enroll subjects with advanced hematologic malignancies who do not have a     suitable related or unrelated donor to undergo a Stem Cell Transplant.      In this study, subjects will undergo a Stem Cell Transplant using Cord Blood. Part of the     cord blood will be used for the Stem Cell Transplant and part of the cord blood will be sent     to a laboratory in order to grow the T cells (from the cord blood) and increase the activity     of the cord blood T cells.      The purpose of this part of the study is to see if it is safe to give study subjects     activated T cells made from a small portion of their donor UCB unit immediately after the UCB     transplant. Activated T cells have been used safely in stem cell transplantation studies in     the past, but they have never been studied UCB transplantation.   "
232617|NCT00891605|"     Safety study of ABT-263 in Combination with Paclitaxel in Subjects with Solid Tumors.   "
232618|NCT00891618|"     The goal of this clinical research study is to learn if giving acupuncture to patients with     lymphoma or a plasma cell dyscrasia can help to relieve numbness and/or tingling of the feet     and/or hands that is related to chemotherapy.   "
232619|NCT00891631|"     The goal of the project is to develop and test an internet/intranet-based Screening, Brief     Intervention, and Referral to Treatment (iSBIRT) system for adolescents that targets a broad     range of serious health-risks and problem behaviors.   "
232620|NCT00891644|"     This is the second phase of a two-phase, cross-sectional study of linkage to medical care of     HIV positive youth. Social, psychological and behavioral factors associated with receipt of     care will be evaluated. This study will also compare three methods for recruitment of     out-of-care youth using a randomized permuted block list of possible sequences.   "
232621|NCT00891657|"     This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open     label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique,     versus good surgical technique alone, with a blinded, third party video evaluation of     adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.   "
232622|NCT00891670|"     The purpose of this study was to determine the impact of adjunctive cilostazol on platelet     inhibition in carriers and non-carriers of the loss-of-function CYP2C19 allele.   "
232624|NCT00891696|"     Muscle wasting, which involves the loss of muscle tissue, is common in many conditions, such     as cancer, AIDS, trauma, kidney failure, bone fracture, and sepsis. It is also prevalent     among the elderly and in people who experience periods of physical inactivity and     weightlessness. Muscle wasting can lead to overall weakness, immobility, physical dependence,     and a greater risk of death when exposed to infection, surgery, or trauma. There is a need to     develop scientifically based treatments that prevent muscle wasting. As one step towards such     a goal, this study will examine the physiological and cellular mechanisms that regulate     skeletal muscle growth.   "
232625|NCT00891709|"     The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data     when LEO 29102 is administered cutaneously as single and multiple doses to healthy male     subjects.      The study is divided into one single dose part followed by a multiple dose part.   "
232626|NCT00891722|"     RATIONALE: Studying samples of tumor tissue and blood in the laboratory may help doctors     learn more about changes that occur in DNA and identify biomarkers related to cancer. It may     also help doctors understand why low-grade gliomas develop in young patients and predict how     they will respond to treatment.      PURPOSE: This clinical trial is studying tumor tissue, blood samples, and family history in     predicting tumor development and response to treatment in young patients with low-grade     glioma.   "
232627|NCT00891735|"     This is a Phase III, multicenter, randomized, double-masked, dose-comparison study of the     efficacy and safety of ranibizumab injection administered intravitreally to patients with     choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).     Results are presented for the first 12 months of the study.   "
232628|NCT00898027|"     RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer     receiving epidermal growth factor receptor inhibitors may help doctors understand the effect     of epidermal growth factor receptor inhibitors on magnesium levels in the body.      PURPOSE: This laboratory study is looking at the effect of epidermal growth factor receptor     inhibitors on magnesium homeostasis in patients with cancer.   "
232629|NCT00898040|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that may occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This laboratory study is looking at DNA samples from patients with multiple myeloma.   "
232630|NCT00898053|"     This laboratory study is looking at tumor samples from patients with Ewing sarcoma. Studying     samples of tumor tissue from patients with cancer in the laboratory may help doctors learn     more about changes that occur in DNA and identify biomarkers related to cancer   "
232631|NCT00898066|"     RATIONALE: Studying the chromosomes in samples of bone marrow and blood in the laboratory     from patients with cancer or other blood diseases may help doctors learn more about the     disease.      PURPOSE: This laboratory study is analyzing chromosomes in patients with newly diagnosed     multiple myeloma or other blood disease.   "
232632|NCT00898079|"     This study is collecting and storing malignant, borderline malignant neoplasms, and related     biological samples from young patients with cancer. Collecting and storing samples of tumor     tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help     the study of cancer in the future.   "
232633|NCT00898092|"     RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to     study in the laboratory may help doctors learn more about changes that may occur in DNA and     identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking at changes in the DNA of tissue samples that were     collected from patients with acute myeloid leukemia.   "
232634|NCT00898118|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is looking at blood samples in young patients with cytopenia     after undergoing a donor stem cell transplant.   "
232635|NCT00898131|"     RATIONALE: Collecting and storing samples of tumor tissue from patients with breast cancer to     study in the laboratory may help doctors learn more about cancer.      PURPOSE: This phase I study is collecting tissue samples for future research from women     undergoing surgery for breast cancer.   "
232636|NCT00898144|"     RATIONALE: Studying Pap smears in the laboratory from women with atypical glandular cells of     unspecified significance may help doctors learn more about changes that may occur in DNA and     identify biomarkers related to cancer.      PURPOSE: This research study is looking at Pap smears from women enrolled on clinical trial     GOG-171.   "
232637|NCT00898157|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer. It may also help doctors     understand how patients respond to treatment.      PURPOSE: This laboratory study is looking at biomarkers using tissue samples from older     patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or     without rituximab on clinical trial ECOG-E4494.   "
232638|NCT00898170|"     The effect of myoma removal was studied on 28 patients with hypertension and myoma by holter     monitoring and erythropoetin level check.   "
232639|NCT00898183|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients will respond to     treatment.      PURPOSE: This laboratory study is assessing genes and immune response in tumor samples from     patients with locally advanced or metastatic melanoma.   "
232640|NCT00898209|"     RATIONALE: Collecting and storing samples of blood and exhaled breath from patients with     cancer and from healthy participants to study in the laboratory may help doctors learn more     about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is collecting and analyzing samples of blood and exhaled breath     from patients who have or are at high risk for lung cancer and from healthy participants.   "
232641|NCT00898222|"     Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal     subjects.   "
232642|NCT00898235|"     RATIONALE: Collecting and storing samples of blood, urine, and tissue from patients with     primary systemic amyloidosis to test in the laboratory may help the study of this disease in     the future.      PURPOSE: This research study is collecting samples from patients with primary systemic     amyloidosis.   "
232644|NCT00898274|"     RATIONALE: Studying samples of blood in the laboratory from patients who are at high risk of     developing prostate cancer may help doctors identify biomarkers related to cancer.      PURPOSE: This research study is looking at blood samples from patients at high risk of     developing prostate cancer and from healthy male participants.   "
232645|NCT00898287|"     The purpose of this study is to identify a dose of P276-00 that can be safely administered     along with Gemcitabine and to examine safety and efficacy of the combination in treatment of     advanced pancreatic cancer.   "
232646|NCT00898300|"     RATIONALE: Collecting and storing samples of tissue, blood, and saliva from patients with     cancer to study in the laboratory may help the study of cancer in the future.      PURPOSE: This laboratory study is collecting and storing tissue samples from patients with     head and neck cancer.   "
232647|NCT00898313|"     RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk     of cancer for laboratory studies may help doctors learn more about changes that may occur in     DNA and identify biomarkers related to cancer.      PURPOSE: This research study is looking at molecular predictors of cancer in patients at high     risk of lung cancer.   "
235012|NCT00929721|"     This study is an observational surveillance study to identify adults 50 years and older who     present to a study healthcare facility with signs and symptoms of Community-Acquired     Pneumonia.   "
232648|NCT00898326|"     RATIONALE: Studying samples of blood and tissue from patients with prostate cancer after     receiving implant radiation therapy and luteinizing hormone-releasing hormone agonist may     help doctors identify biomarkers related to cancer and help doctors predict how patients will     respond to treatment.      PURPOSE: This laboratory study is looking at PSA levels and biopsy samples after undergoing     implant radiation therapy and luteinizing hormone-releasing hormone agonist therapy in     patients with stage I or stage II prostate cancer.   "
232649|NCT00898352|"     RATIONALE: Patient abstract not available      PURPOSE: Patient abstract not available   "
232650|NCT00898365|"     This research trial studies kidney tumors in younger patients. Collecting and storing samples     of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may     help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify     biomarkers related to cancer.   "
232651|NCT00898378|"     RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer,     patients with colorectal polyps and from patients without polyps may help doctors learn more     about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is looking at biomarkers in blood and tissue samples from     patients with colorectal cancer or colorectal polyps and from patients without polyps     (healthy volunteers).   "
232652|NCT00898391|"     This research trial studies is deoxyribonucleic acid (DNA) in blood samples from patients     with neuroblastoma. Studying samples of blood from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how patients will respond to treatment.   "
232653|NCT00898404|"     This laboratory study is looking at response or resistance to chemotherapy in young patients     with acute lymphoblastic leukemia treated with methotrexate. Studying samples of tumor tissue     in the laboratory from patients with cancer may help doctors learn more about changes that     occur in DNA and drug resistance in patients.   "
232654|NCT00898846|"     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict which patients will respond to treatment.      PURPOSE: This laboratory study is looking at prognostic factors in patients receiving     tegafur-uracil for stage II colon cancer that was completely removed by surgery.   "
232655|NCT00898859|"     Despite emerging implications for ADAMs (and matrix metalloproteinases (MMPs)) in disease     progression, the mechanisms that lead to activation of specific ADAMs (and MMPs) and their     actions in chronic obstructive pulmonary disease (COPD) are still incompletely understood. In     the current study, the researchers aim to investigate the effects of cigarette smoke on     cellular parameters that are relevant for development of COPD and the involvement of ADAM     activity in these effects. By studying the effects of ADAM inhibition, the researchers aim to     provide novel insights in the role of ADAMs in the development of COPD, which may offer new     therapeutic targets for the treatment of COPD.   "
232656|NCT00898872|"     RATIONALE: Collecting and storing samples of tissue from patients with non-Hodgkin lymphoma     to study in the laboratory may help the study of cancer in the future.      PURPOSE: This laboratory study is collecting and storing tissue samples from patients with     relapsed or recurrent non-Hodgkin lymphoma after treatment on a Southwest Oncology Group     (SWOG) clinical trial.   "
232657|NCT00898885|"     Introduction: Graft-versus-host-disease (GVHD) is the major cause of morbidity and mortality     in patients submitted to the Bone Marrow Transplantation (BMT). The oral manifestations can     be very debilitating and interfere in the results of medical therapy, leading to systemic     complications, committing the prognosis and quality of life of the patient.      The early diagnosis can be done through biopsies of oral mucosa with or without apparent     injury clinic. The association between the clinical and histopathological tables of GVHD,     especially through the use of recent consensus established in these areas, can bring new     benefits to physicians.      Objective: This study aims to apply and compare the two classifications histological to GVHD,     Horn (1995) and Consensus (2006) in specimens obtained from clinical oral lesions suggestive     of GVHD; correlate them with clinical classification according Akpek (2001) and with the     survival of the patients.   "
232658|NCT00898898|"     This research study is looking at tissue samples from women with breast cancer who were     treated on clinical trial NCCTG-N9831. Studying samples of tissue from patients with cancer     in the laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients will respond to     treatment.   "
232659|NCT00898911|"     RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at blood sample analysis in predicting overall     survival in patients with recurrent or metastatic head and neck cancer.   "
232660|NCT00898924|"     RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the     laboratory may help doctors learn more about changes that may occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations and     k-ras oncogene mutations in patients with stage III non-small cell lung cancer.   "
232661|NCT00898937|"     RATIONALE: Studying samples of breast tissue in the laboratory may help doctors learn more     about the genes and proteins found in breast tissue.      PURPOSE: This phase I trial is studying genes and proteins in breast tissue from women     undergoing surgery for breast cancer or core biopsy of the breast.   "
232662|NCT00898950|"     This study was set up to assess the effects of different doses of aspirin when compared with     placebo (dummy drug), used sequentially over a 2 week study period with a 2 week wash-out     (rest period) in between, in people with type-2 diabetes and high cardiovascular risk.     Specifically, its effects on different factors which are thought to contribute to diabetes     such as insulin resistance (body's ability to effectively use insulin), dysglycaemia (excess     glucose in the blood), oxidative stress (effects from accumulation of by-products of     metabolism), endothelial function (function of lining of blood vessels) and inflammation were     studied.   "
232663|NCT00898963|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer. It may also help doctors     predict how patients respond to treatment.      PURPOSE: This laboratory study is looking at biomarkers in patients with stage III or stage     IV follicular lymphoma treated on clinical trial E-1496.   "
232664|NCT00898976|"     RATIONALE: Studying samples of tumor tissue in the laboratory from Native American women with     breast cancer may help doctors identify and learn more about biomarkers related to breast     cancer in these patients. It may also help doctors learn more about the prognosis of these     patients.      PURPOSE: This laboratory study is looking at biomarkers in Native American women with breast     cancer.   "
232665|NCT00898989|"     Comparison of a group of 20 IBM patients with 20 controls matched on age, gender and weight.   "
232666|NCT00899002|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This laboratory study is looking at biomarkers in stored tumor samples from younger     patients with liver cancer.   "
232667|NCT00899015|"     RATIONALE: Studying bone marrow and blood samples from patients with leukemia or lymphoma     treated with arsenic trioxide may help doctors learn more about cancer.      PURPOSE: This research study is assessing arsenic trioxide in young patients with recurrent     or refractory leukemia or lymphoma who were treated on clinical trial NCI-00-C-0070J.   "
232668|NCT00899028|"     RATIONALE: Studying samples of tissue, blood, sputum, and urine from patients with lung     cancer and from healthy participants in the laboratory may help doctors learn more about     changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is looking at biomarkers for lung cancer using tissue samples     from patients with lung cancer and from healthy participants.   "
232669|NCT00899041|"     The purpose of this study is to investigate whether subjects receiving a high-flexion knee     prosthesis show a better knee function than patients receiving a standard knee prosthesis.     Thigh-calf contact force measurements are used to quantify knee function. The investigators'     hypothesis is that high-flexion knees show a better knee function.   "
232670|NCT00899054|"     The purpose of this study is to identify a dose of P276-00 that can be safely administered     along with Radiation and to examine safety and efficacy of the combination in treatment of     advanced head and neck cancer.   "
232671|NCT00899080|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at blood samples from patients with multiple myeloma     who were treated with thalidomide or lenalidomide.   "
232672|NCT00899093|"     This research trial studies chitinase 3-like 1 (cartilage glycoprotein-39) (YKL-40) in serum     samples from patients with newly diagnosed stage III-IV ovarian epithelial, primary     peritoneal cavity, or fallopian tube cancer receiving chemotherapy. Studying samples of serum     in the laboratory from patients receiving chemotherapy may help doctors learn more about the     effects of chemotherapy on cells. It may also help doctors understand how well patients     respond to treatment.   "
232673|NCT00899119|"     RATIONALE: Collecting and storing stem cells to study in the laboratory may help doctors     learn more about collecting stem cells from patients who have undergone treatment for     Waldenstrom's macroglobulinemia.      PURPOSE: This laboratory study is collecting stem cells from patients with Waldenstrom's     macroglobulinemia.   "
232674|NCT00899132|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is evaluating a tumor marker for testicular cancer, skin cancer,     small intestine cancer, and pancreatic cancer.   "
232675|NCT00899145|"     This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation     carriers. Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation     carriers may help doctors identify biomarkers related to cancer.   "
232676|NCT00899158|"     RATIONALE: Learning about biological markers in patients with pancreatic cancer and cachexia     may help doctors predict patient outcome and may help the study of cancer in the future.      PURPOSE: This laboratory study is examining biological markers in patients with pancreatic     cancer experiencing weight loss.   "
232677|NCT00899171|"     RATIONALE: Studying samples of bone marrow and blood in the laboratory from patients with     cancer may help doctors learn more about changes that occur in DNA and identify biomarkers     related to cancer.      PURPOSE: This research study is looking at bone marrow and blood samples from patients with     acute myeloid leukemia.   "
232678|NCT00899184|"     RATIONALE: Collecting and storing samples of blood from patients and their brothers with     cancer to study in the laboratory may help doctors learn more about changes that may occur in     DNA and identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking at changes in DNA in patients and their brothers     with prostate cancer.   "
232679|NCT00899197|"     RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may     help doctors identify and learn more about biomarkers related to tamoxifen resistance.      PURPOSE: This laboratory study is looking at tamoxifen resistance in women with stage I,     stage II, stage IIIA, or stage IIIB breast cancer.   "
232680|NCT00899210|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research trial is studying matrix metalloproteinases after surgery or     radiofrequency ablation in patients with liver metastases from colorectal cancer.   "
232697|NCT00899483|"     The investigators have previously demonstrated that the administration of insulin in the form     of an infusion with additional sugar and potassium may improve cardiovascular performance and     reduce biochemical evidence of heart muscle injury in non-diabetic patients undergoing     coronary artery surgery. The investigators now seek to demonstrate that similar benefits can     be achieved in diabetic patients by administering insulin to maintain as near absolutely     normal sugar levels as possible.   "
232681|NCT00899223|"     As one of the nation's largest cooperative cancer treatment groups, the Alliance for Clinical     Trials in Oncology (Alliance) is in a unique position to organize a Leukemia Tissue Bank. The     member institutions diagnose hundreds of patients with leukemia or myelodysplastic syndrome     each year, and uniformly treat these patients with chemotherapy regimens. The Alliance offers     centralized data management for the clinical history, the classification of the leukemia and     myelodysplastic syndrome, cytogenetics, flow cytometric analysis, treatment and follow-up.     The highly skilled health care providers at each member institution are familiar with     obtaining informed consent, completing data questionnaires and shipping specimens. There     currently exists a central processing facility where samples are prepared for a variety of     cellular and molecular studies. Hence, the patient resources, the health care providers, and     a processing facility for a Leukemia Tissue Bank are all in place. What is needed, however,     and is addressed in the current protocol, is a formal mechanism to procure bone marrow, blood     and normal tissue from patients with hematologic malignancies who are to be enrolled on     Alliance (Cancer and Leukemia Group B [CALGB]) treatment studies.   "
232682|NCT00899262|"     RATIONALE: Collecting and storing samples of sputum and tissue to study in the laboratory may     help doctors identify biomarkers related to cancer.      PURPOSE: This research study is looking samples of sputum and tissue from lung cancer     patients, participants at high risk for developing lung cancer, and from healthy volunteers     (both smokers and non-smokers).   "
232683|NCT00899275|"     RATIONALE: Collecting and storing samples of tumor tissue and blood from patients to test in     the laboratory may help the study of cancer in the future.      PURPOSE: The purpose of this study is to collect and store samples of blood and tumor tissue     from patients with osteosarcoma.   "
232684|NCT00899288|"     RATIONALE: Studying samples of fingernails in the laboratory from patients with breast cancer     may help in evaluating bone health in postmenopausal women undergoing hormone therapy for     breast cancer.      PURPOSE: This laboratory study is examining fingernails as a way of evaluating bone health in     postmenopausal women with breast cancer undergoing hormone therapy on clinical trial     IBCSG-1-98.   "
232685|NCT00899301|"     RATIONALE: Collecting and storing samples of tissue, blood, and urine from patients with or     without breast cancer to study in the laboratory may help the study of cancer.      PURPOSE: This research study is collecting and storing tissue samples from women with or     without breast cancer.   "
232686|NCT00899327|"     RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients at risk     of developing myelodysplastic syndrome may help doctors learn more about changes that occur     in DNA and identify biomarkers related to disorders of the blood and bone marrow.      PURPOSE: This research study is looking at biomarkers in patients at risk of developing     myelodysplastic syndrome or other disorders and in healthy participants.   "
232687|NCT00899340|"     RATIONALE: Studying the proteins expressed in samples of tumor tissue from patients with     cancer may help doctors identify and learn more about biomarkers related to cancer. It may     also help doctors plan better treatment for patients with cancer of the oropharynx.      PURPOSE: This laboratory study is looking at protein expression in tumor tissue samples from     patients with cancer of the oropharynx.   "
232688|NCT00899353|"     Escalating doses of Omega 3 Fatty Acids are being used in patients who have early stage     Chronic Lymphocytic Leukemia (ES-CLL), Monoclonal Gammopathy of Undetermined Significance     (MGUS), or Smoldering Multiple Myeloma (SMM), whose disease does not currently require     treatment. The primary aim of the study is to determine if the Omega 3 supplementation will     help prevent or delay progression of the disease to a stage that requires treatment.   "
232689|NCT00899366|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking at tissue samples from patients with T-cell acute     lymphoblastic leukemia.   "
232690|NCT00899379|"     A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine     compared to placebo.   "
232691|NCT00899392|"     Informed consent/assent in pediatric medicine is an accepted and important practice that has     been rarely studied, tested for quality, or optimized for patient satisfaction. In the     pursuit of enhancing and studying pediatric care, the investigators propose, as pediatric     gastroenterologists, assessing the current state of parental and adolescent consent/assent in     upper gastrointestinal endoscopy and offering a computer based education program to improve     it. The investigators will look at outcomes that include anxiety, satisfaction, attainment of     informed consent, and patient flow efficiency in a GI endoscopy suite.   "
232692|NCT00899405|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This laboratory study is looking at tumor tissue samples and blood samples to learn     more about DNA changes in patients with lung cancer.   "
232776|NCT00900588|"     A single center, stratified, randomized and double-blind phase II clinical trial was     conducted in adolescents to evaluate the safety and immunogenicity of a split-virion pandemic     influenza A vaccine (H5N1).   "
232693|NCT00899418|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors understand how well patients respond to treatment.      PURPOSE: This laboratory study is examining tumor tissue samples from patients with breast     cancer treated with bevacizumab on clinical trial ECOG-2100 to learn more about DNA changes     and response in these patients.   "
232694|NCT00899431|"     The goal of this clinical research study is to learn if lenalidomide, when given with a stem     cell transplant and chemotherapy (bendamustine, fludarabine, and rituximab), can help to     control CLL. The safety of this treatment combination will also be studied.   "
232695|NCT00899457|"     RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from     healthy participants in the laboratory may help doctors learn more about changes that occur     in DNA and identify biomarkers related to cancer. It may also help doctors learn more about     the development of cancer.      PURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer     development using tissue samples from healthy participants.   "
232696|NCT00899470|"     To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate     release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg     metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.   "
232698|NCT00899496|"     RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer     and from healthy participants may help doctors learn more about cancer.      PURPOSE: This laboratory study is looking at an assay in determining cancer resistance in     patients with metastatic cancer and in healthy participants.   "
232699|NCT00899509|"     This research trial studies deoxyribonucleic acid (DNA) in tumor tissue from women with     node-positive breast cancer to see if genetic factors are related to the patient's response     to chemotherapy. DNA analysis of tumor tissue may help doctors predict how well patients will     respond to treatment with certain chemotherapy drugs.   "
232700|NCT00899522|"     RATIONALE: Collecting and storing samples of tumor tissue from patients with Fanconi anemia     to test in the laboratory may help the study of cancer in the future.      PURPOSE: This laboratory study is collecting and storing tumor tissue samples from patients     with Fanconi anemia.   "
232701|NCT00899535|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is looking at the cancer genome using tumor samples from     patients with stage I or stage II non-small cell lung cancer treated on clinical trial     ACOSOG-Z0030.   "
232702|NCT00899548|"     RATIONALE: Studying samples of blood from patients with cancer and from healthy participants     in the laboratory may help doctors learn more about changes that may occur in DNA and     identify biomarkers related to cancer. It may also help doctors predict how well patients     will respond to systemic therapy.      PURPOSE: This laboratory study is looking at DNA in predicting response after systemic     therapy in women with metastatic breast cancer.   "
232703|NCT00899561|"     In a previous study (Berger el al. Old and new aspects of middle turbinate histopathology.     Otolaryngol Head Neck Surg. 2009;140:48-54), the investigators reported significant     histopathologic changes in the middle turbinate mucosa of patients with chronic     rhinosinusitis compared with normal controls. However, patients' mean Lund-MacKay CT score     was 6.5±6.7 and were considered as having a relatively limited sinus disease (a score of     1-8). Nine to sixteen was considered as intermediate sinus disease, and 17-24 extensive. No     osteomyelitic changes were seen in this study group.      The investigators hypothesize that a comparison between the three groups of patients with     chronic rhinosinusitis having limited, intermediate, and extensive sinus disease would show     that the higher the CT staging, the greater the histopathologic changes of the middle     turbinate. The investigators also expect to find osteomyelitic changes in the middle     turbinate of patients with higher CT staging.   "
232704|NCT00899574|"     The purpose of this trial is to determine the safety and efficacy of Imiquimod, a Toll-like     receptor 7 agonist in breast cancer (for chestwall recurrences or metastases to the skin).   "
232705|NCT00899587|"     In this study, patients were divided into 3 group with 35 cases including: 1.oxygen     2.enalapril 3.control.      In the beginning of the study, best corrected visual acuity (BCVA), uncorrected visual acuity     (UCVA), and optical coherence tomography (OCT) were measured. Patients in the oxygen group     were given oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second     month and every other day at the third month. In the enalapril group, patients were given     enalapril 5 mg every night and placebo was given for the patients in third group. At the end     of first month the patients' vision was checked again and at the the end of the third month     the first physical examinations were performed. In the first group, arterial blood gas (ABG)     was taken before and after oxygen therapy as well.   "
232706|NCT00899600|"     Noxious stimuli occurring intraoperatively and postoperatively generate central     sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements.     The pathophysiology of central sensitization is thought to involve excitatory amino acid     receptors such as N-methyl-d-aspartate (NMDA) (1, 2). Ketamine is a N-methyl-d-aspartate     (NMDA) receptor antagonist that has been shown to be useful in the reduction of acute     postoperative pain and analgesic consumption in a variety of surgical interventions (3).      Spine surgery provides a unique opportunity to evaluate the preemptive and preventative     impact of ketamine on the primary end points of postoperative 24 and 48 hour opioid     consumption in patients with chronic pain. The goal of this IRB approved double blinded,     prospective, randomized placebo controlled trial is to quantify the preemptive and     preventative analgesic effects of ketamine infusions in this patient population. Such insight     may lead to better pain control, improved satisfaction, and ultimately a reduction in     side-effects related to postoperative opioid use.   "
232707|NCT00899613|"     RATIONALE: Studying levels of mesothelin and osteopontin in samples of blood from patients     with mesothelioma or atypical mesothelial hyperplasia may help doctors identify biomarkers     related to cancer.      PURPOSE: This research study is looking at mesothelin and osteopontin as diagnostic markers     in patients with mesothelioma or atypical hyperplasia.   "
232708|NCT00899626|"     RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from     patients with cancer and from healthy participants may help doctors identify and learn more     about biomarkers related to cancer.      PURPOSE: This research study is looking at gastrointestinal biomarkers in tissue and     biological fluid samples from patients and healthy participants undergoing colonoscopy,     endoscopy, or surgery.   "
232709|NCT00899639|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is looking at tumor tissue samples from patients with     early-stage breast cancer.   "
232710|NCT00899652|"     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This laboratory study is looking at DNA in bone marrow and blood samples from young     patients with acute myeloid leukemia or acute lymphoblastic leukemia.   "
232711|NCT00899665|"     RATIONALE: Collecting and storing samples of bone marrow and tissue from patients to test in     the laboratory may help the study of cancer.      PURPOSE: This laboratory study is comparing proteases (enzymes that break down protein) in     patients with prostate cancer that has spread to the bone with patients who do not have     cancer that has spread to the bone.   "
232714|NCT00899704|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is looking at tissue samples in predicting oral cancer in     patients who have undergone neck dissection for oral cancer.   "
232715|NCT00899717|"     The purpose of this study is to determine whether occlusal adjustment by selective grinding     and/or occlusal addition is an effective treatment of chronic temporomandibular joint     disorders.   "
232716|NCT00899743|"     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study is looking at blood and bone marrow samples from patients with     previously untreated primary acute myeloid leukemia.   "
232717|NCT00899756|"     RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the     laboratory may help doctors learn more about changes that may occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations in     the blood of patients with advanced non-small cell lung cancer.   "
232718|NCT00899769|"     RATIONALE: Studying samples of blood, tissue, and saliva in the laboratory from patients with     cancer and from healthy volunteers may help doctors identify and learn more about biomarkers     related to cancer.      PURPOSE: This laboratory study is looking at biomarkers in patients with head and neck cancer     and in healthy volunteers.   "
232719|NCT00899782|"     This research studies collecting and storing tissue and blood samples from patients with lung     cancer who are undergoing surgery. Collecting and storing samples of tissue and blood from     patients with lung cancer to study in the laboratory may help doctors learn more about     changes that may occur in deoxyribonucleic acid (DNA) and identify biomarkers related to     cancer.   "
232720|NCT00899795|"     RATIONALE: Studying samples of bone marrow from patients with cancer and from healthy     volunteers in the laboratory may help doctors learn more about changes that occur in bone     marrow stromal (connective tissue) cells. It may also help doctors understand the effects of     alkylating agents on bone marrow stromal cells.      PURPOSE: This laboratory study is evaluating stromal cells in patients with acute myeloid     leukemia, myelodysplastic syndromes, or Fanconi anemia; in patients who were exposed to     alkylating agents; and in healthy volunteers.   "
232721|NCT00899808|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is looking at molecular markers and genetic markers in patients     undergoing radiation therapy for cancer.   "
232722|NCT00899821|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about how interleukin-2, interleukin-12, and GM-CSF delivered in     microspheres increase the body's ability to kill tumor cells.      PURPOSE: This laboratory study is looking at microsphere-delivered cytokines to see if they     increase tumor response in lymphocytes from patients with head and neck cancer.   "
232723|NCT00899834|"     This multi-institutional study will prospectively collect tumor and constitutional tissue     samples from patients with diffuse brainstem glioma and other types of brainstem gliomas     either during therapy or at autopsy to perform an extensive analysis of genetic and molecular     abnormalities in these tumors.   "
232724|NCT00899847|"     To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant     approach for patients with advanced stage multiple myeloma.   "
232725|NCT00899860|"     RATIONALE: Studying the genes and proteins expressed in tissue samples from patients with     cancer may help doctors identify biomarkers related to cancer.      PURPOSE: This laboratory study is evaluating gene and protein expression in normal tissue and     tumor tissue from patients who have undergone surgery for kidney cancer.   "
232726|NCT00899873|"     RATIONALE: Studying samples of cells in the laboratory from patients with cancer may help     identify biomarkers related to cancer. It may also help doctors learn how patients respond to     treatment.      PURPOSE: This laboratory study is analyzing samples of cells from patients with chronic     lymphocytic leukemia who were treated on clinical trial ECOG-2997.   "
232727|NCT00899899|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about cancer and the development of drug resistance in patients.      PURPOSE: This laboratory study is looking at resistance to methotrexate in patients with     acute lymphoblastic leukemia in relapse or remission.   "
232728|NCT00899912|"     RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the     laboratory may help doctors learn more about changes that may occur in DNA after radiation     therapy and identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking at changes in DNA after radiation therapy in     patients with prostate cancer.   "
232729|NCT00899951|"     RATIONALE: Studying blood samples from cancer patients undergoing pain treatment in the     laboratory may help doctors learn more about how pain drugs work in the body. It may also     help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at fentanyl in patients with cancer.   "
232730|NCT00899964|"     Though possibly cost-saving, there is little scientific evidence for the effectiveness and     reasonable modality of internet-delivered physical activity interventions in primary     prevention. The aim of the study is to compare the influence of different personal and     IT-based service levels on the activity outcome of obese, sedentary persons to evaluate the     minimum level of service necessary for a maximum increase in activity and weight reduction.   "
232731|NCT00899977|"     A pilot study of subjects with refractory hypertension (on 3 concomitant agents with SBP >     140 mmHg and a DBP > 90 mmHg) randomized in a double-blind fashion to receive 4 single     escalating doses of study medication in clinic.   "
232732|NCT00899990|"     This research study is collecting and storing samples of tumor tissue, bone marrow, and blood     from patients with Ewing sarcoma. Collecting and storing samples of tumor tissue, bone     marrow, and blood from patients with cancer to test in the laboratory may help the study of     cancer in the future.   "
232733|NCT00900003|"     RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help     doctors identify and learn more about biomarkers related to cancer. It may also help doctors     predict how patients will respond to treatment.      PURPOSE: This research study is studying biomarkers in patients with pancreatic cancer.   "
232734|NCT00900016|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study is assessing fibroblast activity in patients with localized     pancreatic cancer undergoing surgery.   "
232735|NCT00900029|"     This is a 24-week observational follow safety study for Study 802-247-09-015.   "
232736|NCT00900042|"     RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will     respond to treatment.      PURPOSE: This laboratory study is analyzing the DNA in tumor tissue from patients with     metastatic kidney cancer.   "
232737|NCT00900055|"     RATIONALE: Analyzing tissue and blood samples from healthy volunteers or patients with     Fanconi anemia, myelodysplasia, myeloproliferative disorders, or myeloma in the laboratory     may help doctors learn more about the causes of blood cancers.      PURPOSE: The purpose of this study is to analyze in the laboratory blood and bone marrow     cells from healthy volunteers or patients with Fanconi anemia, myeloproliferative disorders,     or myeloma.   "
232738|NCT00900068|"     RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help     doctors learn more about nausea and vomiting caused by cancer treatment.      PURPOSE: This laboratory study is looking at blood samples from patients with cancer who were     treated on a clinical trial to control nausea and vomiting during donor stem cell transplant.   "
232739|NCT00900081|"     RATIONALE: Studying samples of tissue from patients with or without cancer in the laboratory     may help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This laboratory study is looking at cyclooxygenase-2 expression in tissue samples     from patients with a normal cervix, cervical intraepithelial neoplasia, or early invasive     cervical cancer.   "
232740|NCT00900094|"     RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with     cancer and blood from healthy participants may help doctors learn more about changes that may     occur in DNA and identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking at cancer-related protein biomarkers in the blood     and tumor tissue of patients with cancer and in the blood of healthy participants.   "
232741|NCT00900107|"     Only few data are available on the influence of strenuous exercise on the content of     circulating progenitor cells and especially the timeframe of their release. The aim of the     present study was to investigate the potential influence of 4 hours of cycling on the     time-dependent release of progenitor cells.   "
232742|NCT00900120|"     RATIONALE: Collecting and storing samples of blood from patients with cancer to test in the     laboratory may help the study of cancer in the future.      PURPOSE: This research study is collecting and storing blood samples from patients with     cancer.   "
232743|NCT00900133|"     RATIONALE: Measuring levels of calgranulin A and calgranulin B in the blood of patients with     breast cancer in the laboratory may help doctors identify and learn more about biomarkers     related to breast cancer.      PURPOSE: This laboratory study is measuring calgranulin A and calgranulin B levels in the     blood of patients with newly diagnosed stage I, stage II, or stage III breast cancer.   "
232744|NCT00900146|"     This was a four month dose ranging study followed by a 24 to 48 month extension at the     selected dose to characterize the safety and efficacy of the injectable IL-1B (interleukin 1,     beta) antagonist canakinumab in the treatment of patients with Type 2 diabetes mellitus     (T2DM) already treated on maximum dose metformin.   "
232745|NCT00900159|"     The purpose of this study is to test the effects of eszopiclone on daytime sleep and     overnight wakefulness in shift workers.   "
232746|NCT00900172|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at blood and tissue samples from patients with     locally advanced, metastatic, or recurrent non-small cell lung cancer treated with     bevacizumab, carboplatin, and paclitaxel.   "
232747|NCT00900185|"     RATIONALE: Studying samples of blood from patients with cancer and from healthy participants     in the laboratory may help doctors learn more about changes that may occur in DNA.      PURPOSE: This laboratory study is looking at blood samples from patients with prostate cancer     and from healthy participants to identify a polymorphism that may help in the study of     prostate cancer.   "
232815|NCT00901121|"     The purpose of the study was to test a clinically relevant non-inferiority of Straumann     BoneCeramic treatment compared to Bio-Oss treatment 180 to 240 days after sinus grafting     procedure.   "
234462|NCT00916591|"     The purpose of this study is to compare the effect of two drugs that can help in the     prevention of regurgitation during the administration of enteral nutrition and define which     one is the most effective.   "
232748|NCT00900198|"     Background:      -Patients who are being evaluated or are on research protocols at the NIH Clinical Center or     at participating sites will be entered onto this screening and tissue procurement protocol     for collection of tissue specimens.      Objectives:      -To obtain samples for research purposes from tests performed for clinical indications or     research indications on other research protocols, and to obtain samples for research purposes     from non-surgical procedures, performed for the sole purpose of obtaining samples for this     protocol.      Eligibility:      -Patients who are being evaluated for and/or treated on protocols within the NIH Clinical     Center or at participating sites.      Design:        -  Specimens for research purposes, as outlined in this protocol, will be obtained from          tests and procedures that are done as required by the primary research protocols that a          given patient is enrolled in.        -  These procedures may include, but are not limited to, laboratory tests on blood, CSF,          urine or other specimens; and needle biopsies.        -  Given the risks associated with any procedure, the procedure will be discussed in detail          with the patients, including the side effects, prior to obtaining a separate consent for          each procedure.        -  Tissues and biological fluids to be procured may include but are not limited to blood,          serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial          alveolar lavage (BAL), and bone marrow. These specimens will be stored without patient          identifiers and used to perform only those research studies that are outlined in this          protocol. Patients can opt to donate samples to create preclinical models to study tumor          biology and genetics, and to develop new therapies for cancer.      Once a patient is taken off study, he or she may be re-consented and enrolled at a later time     to obtain another research specimen as part of this protocol.   "
232749|NCT00900211|"     RATIONALE: Collecting and storing samples of tumor tissue from patients with soft tissue     sarcoma to test in the laboratory may help the study of cancer in the future.      PURPOSE: This laboratory is collecting tissue samples from patients with soft tissue sarcoma     of the arms, hands, legs, or feet treated on clinical trial CRUK-VORTEX.   "
232750|NCT00900224|"     RATIONALE: Studying samples of tissue and blood from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This research study is looking at tissue and blood samples from patients with acute     myeloid leukemia.   "
232751|NCT00900237|"     This purpose of this study is to measure the concentrations of two anti-epileptic drugs     (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid     and blood plasma of healthy subjects and also to assess how these drugs are tolerated.   "
232752|NCT00900250|"     This laboratory study is collecting and storing samples of tissue and blood from young     patients with Hodgkin's lymphoma. Collecting and storing samples of tumor tissue and blood     from patients with cancer to study in the laboratory may help the study of cancer in the     future.   "
232753|NCT00900263|"     RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with     monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     these diseases. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at blood and bone marrow samples from patients with     monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma.   "
232754|NCT00900276|"     RATIONALE: Studying samples of blood and urine from patients with cancer and from healthy     participants in the laboratory may help doctors identify and learn more about biomarkers     related to cancer.      PURPOSE: This laboratory study is looking at biomarkers in patients with kidney cancer or     cancer of the urothelium and in healthy participants.   "
232755|NCT00900289|"     RATIONALE: Studying tissue and blood samples from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how patients respond to treatment.      PURPOSE: This laboratory study is evaluating DNA to see how well it predicts response to     treatment in patients with stage I, stage II, stage III, or stage IV ovarian epithelial     cancer.   "
232756|NCT00900302|"     RATIONALE: Studying protein expression in sentinel lymph node tissue from patients with     cancer in the laboratory may help doctors identify and learn more about biomarkers related to     cancer. It may also help the study of cancer in the future.      PURPOSE: This laboratory study is evaluating OX-40 protein expression in the sentinel lymph     nodes of patients with cancer.   "
232757|NCT00900328|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This laboratory study is looking at tumor samples from patients with lung cancer.   "
232758|NCT00900341|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is looking at tumor tissue samples from patients with soft     tissue sarcoma.   "
232759|NCT00900354|"     RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving     dactinomycin may help doctors learn how dactinomycin works in the body and how patients will     respond to treatment.      PURPOSE: This laboratory study is evaluating the pharmacokinetics of dactinomycin in young     patients with cancer.   "
232760|NCT00900367|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about nutrition-related changes that identify biomarkers related to     cancer. It may also help doctors predict a woman's risk of developing breast cancer.      PURPOSE: This laboratory study is looking at nutrition-related biomarkers in predicting     breast cancer risk in women.   "
232761|NCT00900380|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about cancer and the development of drug resistance in patients.      PURPOSE: This laboratory study is examining tissue samples from patients with acute myeloid     leukemia to learn more about drug resistance in these patients.   "
232762|NCT00900406|"     RATIONALE: Collecting and storing samples of blood, urine, and tissue from patients     undergoing a donor stem cell transplant to test in the laboratory may help the study of     graft-versus-host disease in the future.      PURPOSE: This research study is collecting and storing tissue and DNA samples from patients     undergoing a donor stem cell transplant.   "
232764|NCT00900432|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that may occur in the immune system that may help kill     cancer cells.      PURPOSE: This laboratory study is looking at anticancer immune responses in the peripheral     blood of patients with colon cancer.   "
232855|NCT00894803|"     The primary goal of this trial is to determine if individuals with acute ischemic stroke     treated with a medium dose of IV rt-PA plus IV eptifibatide started within 3 hours of symptom     onset are more likely to have a better outcome than individuals treated with standard IV     rt-PA alone.   "
232765|NCT00900445|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about the affect of body mass index on the way anticancer drugs work in     the body. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This clinical trial is studying body mass index in younger patients receiving     prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute     lymphoblastic leukemia.   "
232766|NCT00900458|"     Primary objective:        -  To investigate whether physical exercise prior to pregnancy in formerly preeclamptic          women results in a comparable improvement of vascular and endothelial functioning as in          women who had an uneventful pregnancy.      Secondary objectives:        -  Which cardiovascular and endothelial parameters are involved in the vascular adaptation          to training in women with a history of preeclampsia.        -  To study the vascular adaptation in the (next) pregnancy in women with a history of          preeclampsia compared with women with a history of an uncomplicated pregnancy, after          improvement of their physical condition by exercise training.      This study is important in order to get a better understanding of the vascular and     endothelial factors involved in preeclampsia and the effects of training on this profile.     Results of this study can contribute to the improvement of preventing hypertensive     complications in pregnancy and reduction of life time risk of cardiovascular disease in     formerly preeclamptic women.   "
232767|NCT00900471|"     RATIONALE: Collecting and storing samples of tissue or blood from patients with cancer for     study in the laboratory may help the study of cancer in the future      PURPOSE: This research study is collecting and storing blood and tissue samples from patients     with suspected solid tumors.   "
232768|NCT00900484|"     RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the     laboratory may help doctors learn more about changes that may occur in DNA and identify     biomarkers related to cancer. It may also help doctors learn how patients respond to     treatment.      PURPOSE: This laboratory study is collecting, analyzing, and storing tissue samples from     patients with non-Hodgkin's lymphoma.   "
232769|NCT00900497|"     Background & Rationale:      About 75% of US population living today will not die of cancer. There has been a recent     report of a colony of cancer-resistant mice developed from a single male mouse that     unexpectedly survived challenges of lethal cancer cell injections. In these so-called     spontaneous regression/complete resistant (SR/CR) mice, cancer cells are killed by rapid     infiltration of leukocytes, mainly of innate immunity. This highly effective natural cancer     immunity is inherited and mediated entirely by white blood cells. Moreover, this cancer     resistance can be transferred to wild type mice through the transfer of various immune cell     types including granulocytes. The infusion of white blood cells, particularly cells of innate     immunity, is a viable anticancer therapy in humans as well. This proposed trial will test     whether white blood cell infusions from healthy unrelated donors can be used to treat cancer.     The trial is designed to determine whether responses can be seen in cancer patients after     infusion of HLA-mismatched white cells from healthy donors. It is important that the donors     and recipients be unrelated and HLA-mismatched to avoid the possibility of     transfusion-related Graft vs. Host Disease. The white blood cells from the healthy donors are     being collected via apheresis following granulocyte mobilization with dexamethasone and     filgrastim. The investigators will refer to the white blood cells as 'granulocytes' because     75-90% of the white blood cells collected through the apheresis will consist of granulocytes.     The dose of at least 2x10 to the11th will be given from 4-5 donors at a rate of no more than     one donor per day for each recipient. There will only be one infusion per day and no more     than 5 infusions per week. Thus, a typical treatment in the study would span 1-2 weeks. After     each infusion, the patients will be monitored carefully for possible adverse events. If     adverse events occur at any time point during or after individual infusion, the treatment can     be stopped until the adverse events can be managed. The daily dose of each infusion is a     frequently used level that has a long safety record. The trial will observe the subject's     cancer for 3 months after the granulocyte infusions are completed. Response at 90 days will     be based on comparison of tumor measurements at baseline. The trial has 3 major endpoints:     dose response and tolerance, safety, and efficacy.   "
232770|NCT00900510|"     Background: Skin abscesses are a growing problem in the general pediatric population around     the world. While the standard treatment for an abscess/boil is incision and drainage, many     physicians also prescribe antibiotics, despite the lack of evidence that antibiotics are     necessary to help the wound heal. The purpose of this research study is to determine whether     antibiotics are necessary after incision and drainage of a skin abscess in children. This is     an important question because medical evidence has shown that using antibiotics when they are     not needed has contributed to the increase of bacterial antibiotic resistance. In fact,     several of the antibiotics that successfully killed Staph bacteria several years ago are now     no longer effective because of antibiotic resistance. Now resistant forms of Staph bacteria,     called Community-Acquired Methicillin-Resistant Staph Aureus (CA-MRSA), account for 50-85%     of all pediatric skin abscesses. If antibiotics are not necessary then withholding them when     appropriate may help slow the progression of antibiotic-resistant Staph infections.      Objective(s) and Hypothesis(es): The investigators believe that antibiotics are no better     than placebo at achieving a cure after drainage of an abscess in a child. The objective of     this study is to answer the question: Do antibiotics after abscess drainage result in a     better chance of cure than placebo?      Potential Impact: If abscess drainage alone is shown to be as effective as drainage followed     by antibiotics, then the routine use of antibiotics for this problem could be avoided. This     would help limit the increasing antibiotic resistance of bacteria (especially CA-MRSA) in     communities around the world. A well-designed study may provide the evidence to change the     way children are treated for abscesses in a future where antibiotic resistant bacteria will     be even more of a public health challenge.   "
232771|NCT00900523|"     RATIONALE: Measuring the amount of prostaglandin metabolite in urine samples and studying     tissue samples in the laboratory from patients with ovarian cancer may help doctors identify     and learn more about biomarkers related to ovarian cancer and may help the study of cancer in     the future.      PURPOSE: This laboratory study is measuring the amount of prostaglandin metabolite in urine     samples from patients with ovarian cancer.   "
232772|NCT00900536|"     RATIONALE: Studying samples of blood and/or tissue in the laboratory from patients with     kidney cancer receiving sorafenib may help doctors learn more about changes that occur in DNA     and identify biomarkers related to cancer. It may also help doctors predict how well patients     will respond to sorafenib.      PURPOSE: This research study is looking at the DNA in blood and/or tissue samples from     patients with primary kidney cancer receiving sorafenib on clinical trial MRC-RE05-SORCE.   "
232773|NCT00900549|"     Heart failure is a major health problem in Canada. Recent advances in medical and device     therapy have helped to reduce the morbidity and mortality of patients with this problem.     Among these treatments, cardiac resynchronization therapy (CRT) has very recently been shown     to be effective to improve functional class, quality of life and exercise tolerance of the     patients with the most severe symptoms of heart failure and a prolonged duration of the QRS     on the 12-lead Electrocardiography (ECG).   "
232774|NCT00900562|"     This study is a phase II clinical and pharmacokinetic trial of PM00104 (Zalypsis®) in     patients with advanced and/or metastatic endometrial or cervical cancer previously treated     with one line of systemic chemotherapy to evaluate the antitumor activity and to determine     the safety profile, the pharmacokinetic profile and the pharmacogenomic profile.   "
232775|NCT00900575|"     The objective of the work described in this protocol is to determine the optical signatures     of cervical dysplasia using optical technologies.   "
234463|NCT00916604|"     The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple     repeated oral doses in Japanese patients with type 2 diabetes.   "
232777|NCT00900601|"     Pelvic girdle pain (PGP) related to pregnancy is a common reason to sick leave during     pregnancy. Low back pain and PGP affects about 50% of women during pregnancy. Most of the     women recover, however about 10% of the women still have complaints after birth. Most     patients have positive effect from conservative treatment, but unfortunately some do still     have much pain despite intensive conservative rehabilitation. Surgery has been tried on these     women with various results. Surgical treatment is controversial and there is a lack of     documentation. The investigators will operate 20 patients with arthrodesis to the sacroiliac     joint and symphysis. Radiostereometric analysis (RSA) will be used to evaluate the joint     movement in different part of the process.      Hypothesis: Severe pelvic girdle pain is caused by pelvic joint instability in some cases and     surgically fixation of the affected joints can help these women to get back to a normal life.   "
232778|NCT00900614|"     The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV)     APR-246 when given to patients with refractory hematologic malignancies or prostate     carcinoma.   "
233313|NCT00909454|"     The purpose of this study is to determine if 14-19 year old African American adolescents are     able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose     of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.   "
232779|NCT00900627|"     The main purpose of this study is to determine if AZD8931 can improve the efficacy of     standard chemotherapy for the treatment of advanced breast cancer. This study will be     conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be     safely administered with paclitaxel chemotherapy. The second part (phase II) will determine     the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast     cancer.   "
232780|NCT00900640|"     The aim of this study is to prospectively document the incidence of CM adverse reactions at     the time of ERCP and to determine whether various perceived risk factors are predictive of     adverse reaction.      Adverse reactions to iodine containing contrast media (CM) have been described after     endoscopic retrograde cholangiopancreaticography (ERCP) but have been difficult to study due     to their extremely low incidence. Adverse reactions can be classified by severity (mild,     moderate or severe) or underlying mechanism (idiosyncratic versus nonidiosyncratic).     Nonidiosyncratic reactions are related to the dose and osmolality of the CM; these are not     observed during ERCP due to the relative small amount of systemic absorption of CM.     Idiosyncratic reactions on the other hand are not dose-dependent and generally occur shortly     after administration of CM.      Premedication with corticosteroids, H1/H2 -blockers and the use of low osmolality CM is     beneficial in preventing nonidiosyncratic reactions during intravascular administration.     However their role in during ERCP is unclear as CM is not injected into the intravascular     space. Currently there are no formal recommendations and clinical practice varies     considerably. The general purpose of this study is to determine the incidence of CM reactions     during ERCP and to determine whether various risk factors are predictive of idiosyncratic     reactions. Based on these results, we hope to develop guidelines for the use of prophylaxis     to prevent CM reactions in ERCP.   "
232781|NCT00900653|"     Recurrent urinary tract infections (UTI) are a problem for postmenopausal women. The aim of     this trial is to evaluate the effectiveness of lactobacilli in combination with low dose     estriol for preventing recurrent urinary tract infections in postmenopausal women.   "
232782|NCT00900666|"     Stiff knee gait is a common gait dysfunction following acquired brain injury. This gait     deviation is characterized by reduced knee flexion during swing phase of the gait cycle and     adversely impacts safe foot clearance. Stiff knee gait is an inefficient gait pattern and     slows walking speed, limiting one's ability to adapt walking to community mobility demands.     Fall risk is increased with this gait problem due to low or ineffective foot clearance.     Common compensatory strategies are employed, such as circumduction, hip hiking or vaulting,     during ambulation.      The purpose of this study is to examine both the immediate (one month post-injection) and     longer-term (4 months post-injection) effects of botulinum toxin injections to the rectus     femoris (RF) on gait function in persons with brain injury. This study is clinically     important to help inform rehabilitation professionals regarding treatment decisions for     management of inefficient and often unsafe stiff knee gait problems following brain injury.      Research Questions:        -  Is there a statistically significant difference in mean peak knee flexion between the          experimental and control group?        -  Is there a statistically significant difference in mean peak knee velocity during the          preswing and initial swing phases of gait between the experimental and control group?        -  Is there a statistically significant difference in gait function (based on 6-Minute Walk          time and temporal distance measures) between the experimental and control group?   "
232783|NCT00900679|"     RATIONALE: A teaching intervention with an advanced practice nurse may help reduce     psychosocial and symptom distress and improve the well-being and quality of life of patients     with ovarian cancer.      PURPOSE: This clinical trial is studying the effects of a teaching intervention with an     advanced practice nurse on quality of life and psychosocial and symptom distress in patients     with ovarian cancer.   "
232784|NCT00900692|"     The purpose of this study is to examine range of motion and lasting effects of Botox     injections along with the use of the Supination Dynasplint.   "
232785|NCT00900718|"     The purpose of this study is to compare a new biomaterial with an already existing treatment     principle (Bio-Oss/Bio-Gide) with regard to their ability to preserve the dimensions of the     alveolar ridge and to promote bone regeneration and to evaluate the early survival rate of     dental implants placed in the augmented socket area and to assess radiographically and     clinically changes of peri-implant soft and hard tissues.   "
232786|NCT00900731|"     This study compared the lung effects of indacaterol to those of tiotropium in patients with     moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.   "
232787|NCT00900744|"     The investigators plan to examine endoxifen and 4-OH-Tam as a function of the tamoxifen dose     in patients with a genetic CYP2D6 polymorphism. The investigators also plan to investigate     other genetic variations in the metabolism of tamoxifen.   "
232933|NCT00902733|"     RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective     than standard care in treating patients with pancreatic cancer.      PURPOSE: This clinical trial is studying nurse-provided care to see how well it works     compared with standard care in treating patients with pancreatic cancer.   "
232788|NCT00900757|"     1. Purpose and objective:        1. To determine the safety and tolerability of palonosetron in the prevention of radiation          induced nausea and vomiting (RINV) in primary glioma patients receiving radiation (RT)          and concomitant temozolomide (TMZ).        2. To determine the efficacy of palonosetron in primary glioma patients receiving six weeks          of RT and concomitant TMZ        3. To evaluate the effect s of palonosetron on the quality of life of primary glioma          patients receiving six weeks of RT and Concomitant TMZ.      2. Study activities and Population group: We will conduct a phase II single arm trial of     Palonosetron (PALO) for the prevention of RINV in primary malignant glioma patients receiving     radiation therapy (RT) and concomitant temozolomide (TMZ). All eligible patients should     receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for     a total of six weeks of treatment. For each week of radiation patients will receive a single     0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction.     This schedule will be repeated for each week of radiation for a total of 6 weeks. Forty     subjects with gliomas will participate.      3. Data analysis and risk/safety issues: The frequency of toxicity will be summarized by type     and the most severe grade experienced. The complete response rate, defined as the proportion     of patients with no emetic episode or use of rescue medication while receiving radiation and     concomitant temozolomide, will be estimated with a 95% confidence interval.   "
232789|NCT00900770|"     The purpose of this study is to determine whether asymptomatic older individuals with high     amyloid burden will subsequently manifest cognitive impairment and eventually progress to     clinical Alzheimer's Disease (AD).   "
232790|NCT00900783|"     The purpose of this study is to compare the safety and efficacy of two doses of FV-100 to     valacyclovir in patients with herpes zoster, or shingles. FV-100 has shown to be very potent     in cells infected with varicella zoster virus, the virus that causes shingles. The study     objectives include:        -  Compare the safety of FV-100 to valacyclovir        -  Compare the effect of FV-100, as compared to valacyclovir, on shingles pain        -  Compare the effect of FV-100, as compared to valacyclovir, on shingles lesions   "
232791|NCT00900796|"     The objective of this observational study is to determine the incidence of response in     patients with predictive factors of major clinical response in active ankylosing spondylitis     (AS) in patients who start anti-tumor necrosis factor (anti-TNF) therapy and correlate these     findings in patients who switch from one to another anti-TNF due to inefficacy under usual     clinical practice conditions in Spain.   "
232792|NCT00900809|"     NK cells from patients with malignant diseases are often functionally impaired. Their     function cannot be fully restored through ex vivo expansion and cytokine activation. In     addition, the in vivo administration of cytokines not only expands NK cells but expands     polyclonal T cells with no tumor specificity and no known effects.      The utilization of Neukoplast™, as a form of adoptive immunotherapy, offers several     advantages. Neukoplast™ represents a uniform cell population with a well-characterized     immunophenotype, confirmed strong anti-tumor activity and are easy to grow and expand in     culture, so that they can be made available in large numbers for therapeutic delivery.   "
232793|NCT00900822|"     Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is     a need for bone augmentation in the posterior upper jaw. 9 months later the bone formation is     evaluated. The patients are followed for 3 years.The study hypothesis is that the SBC is not     worse than BioOss.   "
232794|NCT00900835|"     RATIONALE: Collecting information over time about patients' and health care providers'     understanding of pain and fatigue and providing education about pain and fatigue management     may improve quality of life.      PURPOSE: This clinical trial is studying pain and fatigue management in patients with breast     cancer, prostate cancer, colon cancer, or lung cancer.   "
232795|NCT00900848|"     Traumatic disruption of iliofemoral arterial segment is often associated with multiple     injuries, massive hemorrhage, state of shock, and loss of blood supply to the ipsilateral     lower extremity, as well as with high mortality.      The investigators describe a bypass technique. It can provide adequate blood supply to the     lower extremity of the injury side. Due to a minimum amount of additional blood loss, it is a     low risk procedure for salvage of the extremity and even patient's life.   "
232796|NCT00900861|"     A prospective study led amongst pulmonologists. Patients asthma control level will be     evaluated based on GINA guideline criteria. HRQoL measured by Visual analogue scale. Clinical     practice: non controlled patients therapy assessed.   "
232797|NCT00900874|"     The hypothesis of this study is that the onset of rapid bronchodilatory effect of inhaled     Formoterol (12 microgram) is comparable to that of inhaled salbutamol (200 microgram) i.e.,     the difference in mean forced expiratory volume in 1 second (FEV1) between the 2 groups at 1,     5, 10, 30 and 60 minutes will be less than 10% in children between 5-15 years with mild acute     exacerbation of asthma.   "
232798|NCT00900887|"     The purpose of this study is to determine the efficacy of ocular topic antiinflammatory     therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness     secondary to selective photocoagulation in diabetics with clinically significant macular     edema.   "
232799|NCT00900900|"     This study will evaluate the potential therapeutic value of two neurosteroid treatments (DHEA     and pregnenolone) in the treatment of tobacco withdrawal symptoms. This will include     assessing whether these agents relieve craving for cigarettes elicited by exposure to a     mildly stressful cognitive task. Pregnenolone (400 mg orally), DHEA (400 mg orally) and     placebo will be administered one at each of the three sessions in a randomized order.   "
232800|NCT00900913|"     The purpose of this study is to compare the effect of intravenous ropivacaine and lidocaine     on the receptive field of primary sensory afferents and their influence on the vascular bed.      *Trial with medicinal product   "
232801|NCT00900939|"     The purpose of this study is to determine if a low-fat, vegan diet affects the number of acne     lesions, acne severity, and acne extent.   "
232802|NCT00900952|"     The purpose of this observational study is to assess the prevalence and demographic and     clinical characteristics of infections in elderly people admitted to Internal Medicine wards     in Spain, as well as the etiology and resistance pattern for the main causal agents, and     outcome.   "
232934|NCT00902746|"     The purpose of this long-term study is to determine whether NPC-01 is effective in the     treatment of dysmenorrhea associated with endometriosis.   "
232803|NCT00900965|"     Irritable bowel syndrome (IBS) is the most common digestive disorder that affects more than     5% of population in Hong Kong. However, there is no effective treatment of IBS using Western     Medicine. Acupuncture, a traditional therapeutic modality, has been used in China for     thousands of years for various pain disorders. In addition to analgesia, acupuncture has also     been shown to influence physiology of gastrointestinal tract. The investigators set out to     evaluate the therapeutic value of acupuncture in IBS. The investigators will study its     effects on rectal sensation and brain activity in patients with IBS.      All patients will be evaluated for study eligibility at visit 1 (baseline). Baseline     assessment includes individual IBS symptoms (pain/discomfort, bloating, constipation, and     diarrhea) as perceived by patients will be scored. The syndrome of IBS patients will also be     recorded and analyzed based on the Chinese medicine theories. All patients will then undergo     baseline rectal barostat for thresholds of rectal sensation. At visit 2, eligible patients     will be randomly assigned to either (1) electroacupuncture or (2) sham electroacupuncture     treatment groups. Functional Magnetic Resonance Imaging (fMRI) scanning will be performed     before, during and after the electroacupuncture or sham electroacupuncture treatment.   "
232847|NCT00894699|"     The purpose of this study is to evaluate the safety and effectiveness of a study medication     that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This     drug is being designed to provide mild sedation as well as reduce anxiety and pain before and     during a procedure (in this case elective abdominal liposuction).   "
232967|NCT00903214|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors identify biomarkers related to cancer. Riluzole may help slow the     growth of tumor cells.      PURPOSE: This phase I trial is studying riluzole in women with stage I, stage II, or stage     IIIA breast cancer.   "
232804|NCT00900978|"     Nasopharyngeal (NP) colonization of S. pneumoniae in infants is generally acquired at     approximately 4-6 months of age. Although there are differences in the prevalence and rank     order of serotypes obtained from NP specimens and from those with invasive diseases,     pneumococcal nasopharyngeal isolates may reflect the strains circulating in the community and     may be used as a marker to predict serotype prevalence of invasive disease and resistance     patterns. The information about pneumococcal strains found in Jordanian children and     NP-carriage of infants is limited and do not include children living in rural regions.     Monitoring serotype distribution is essential for the appropriate application of vaccination.     Vaccine use in infants proves to be highly efficacious in the prevention of invasive     pneumococcal disease as well as in decreasing the carriage of vaccine serotypes in the     nasopharynx of infants which impacted significantly in the long run on otitis media infection     and helped decrease the infection rates among contacts of these infants. The result has been     a decrease in the pneumococcal infection rate among elderly contacts of these infants and     decrease colonization with pneumococci. In order to determine the pneumococcal serotypes     which are prevalent among infants attending day care centers (DCCs) in Jordan, a study of     these types circulating among infants will be determined over a period of 15 months in     250-300 children attending the DCCs in Ajlun-City by taking 3 NP-swabs, the first before the     first vaccine injection in May 2009, the second before the third injection at 10 months of     age and the third swab sample is taken at 1 year of age (2-3 months after the last injection     with the 7vPCV. The aims of this study were to determine the frequency of NP-carriage and     serotype distribution of the strains isolated from infants less than 2 years old, and to get     an insight about the coverage of the available and future pneumococcal conjugate vaccines     developed for this infectious agent. Good results of this study project would make     recommendations for the Ministry of Health (MOH) to include the vaccine in the National     Vaccination Program. 15000 doses of the 7v PCV (Prevenar) were donated from Wyeth     Pharmaceutical company to the MOH of Jordan in September 2008. These will be vaccinated in a     vaccine program (for free) over 15 months period in 2009-2010 in one city in north Jordan     called Ajlun. This city has 3676 births per year (Statistics of the MOH 2007). The     vaccination program will start from the 18th of May, 2009, and ending in August 2010. The way     the vaccine will be given is 2 + 1 injections as recommended by the vaccination committee of     the MOH.   "
232805|NCT00900991|"     A single center, stratified, randomized and double-blind phase II clinical trial was     conducted in children to evaluate the safety and immunogenicity of an split-virion pandemic     influenza A vaccine (H5N1).   "
232806|NCT00901004|"     The purpose of this study is to define the endoscopic findings of minimal change that is     significant to clinical significant reflux esophagitis. Through this, the investigators want     to estimate the applicability of minimal change findings of reflux esophagitis to the clinic.   "
232807|NCT00901017|"     The objective of the study is to test the efficacy on bone formation of Straumann Bone     Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed     oral implants.   "
232808|NCT00901030|"     This study will examine the degree of blood thinning (platelet function) in patients coming     for non-cardiac surgery on antiplatelet agents using platelet function tests called     thromboelastography (TEG) and platelet mapping assay (PMA) and major cardiac complications     that occur any time after surgery (perioperative).   "
232809|NCT00901043|"     The purpose of this study is to examine the effects of sustained walnut consumption on     endothelial function and lipid markers in patients with Type 2 diabetes mellitus.   "
232810|NCT00901056|"     Low intensity shockwaves have been proven in animal studies to induce local growth of new     blood vessels from existing ones.      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients     with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.   "
232811|NCT00901069|"     This is a phase I, prospective, open label, dose escalation study of azacitidine in     combination with rituximab, vincristine, and cyclophosphamide for the treatment of refractory     lymphoma. The investigators expect to enroll 12-24 patients in this trial over a 2 year     accrual period.   "
232812|NCT00901082|"     Patient presenting to chronic pain clinics frequently undergo diagnostic and therapeutic     spinal injections as part of their treatment. These procedures can cause significant level of     apprehension in patients, which can lead to increased procedural times, increased procedural     pain and reluctance to continue with the treatment program. It appears that certain     interventions could reduce the anxiety and catastrophization levels and modify pain     perception during medical procedures. The investigators therefore sought to evaluate the     effect of a single 30 minutes information session which includes relaxation training     administered 5 to 6 days before the nerve block procedure on patient's anxiety and     catastrophization levels prior to the procedure and pain scores during the procedure, as well     as the overall level of satisfaction with care received.   "
232813|NCT00901095|"     The goal of the study is to investigate the efficacy of an evidence-based weight loss     intervention, on a background of quality health care, on asthma control among obese adults.     The intervention will employ a combination of recommended dietary and physical activity     changes, and behavioral modification techniques.   "
232814|NCT00901108|"     The purpose of this study is to compare the efficacy and safety of Trabectome versus     Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with     open angle glaucoma.   "
232816|NCT00901134|"     Recently, early defibrillation and cardiopulmonary resuscitation (CPR) for sudden onset of     cardiac arrest are advancing, however, survival rate is still very low in the world.     Furthermore, post-cardiac arrest brain injury is a common cause of morbidity and mortality     after successful resuscitation which is urgent issue to be solved. Therapeutic hypothermia is     part of a standardized treatment strategy for comatose survivors of cardiac arrest in the     metabolic phase usually about 15 minutes after cardiac arrest. However, the evidences of the     efficacy of therapeutic hypothermia are still few. The optimal candidates, temperature, the     timing of initiation, the therapeutic windows and the rate for rewarming have not been     defined clinically and should be established. The purpose of this research is the improvement     in the outcomes for patients with coma after resuscitation from out-of-hospital cardiac     arrest using therapeutic hypothermia established from the analysis of multicenter registry     data.   "
232817|NCT00901147|"     The purpose of this study is to determine whether intravenous Bortezomib combined with oral     Panobinostat (LBH589) are effective in treating adult patients with relapsed/refractory     peripheral T-cell lymphoma or NK/T-cell lymphoma after the failure of conventional     chemotherapy.   "
232818|NCT00901160|"     Can a post-operative analysis using a simple blood test (Thromboelastography(TEG®)) and     Platelet Mapping Assay (PMA™) be able to detect the occurence of clotting or bleeding     complications in patients on blood thinning (anti-platelet) agents?   "
233381|NCT00902122|"     This is multicenter, open-label, randomized, active-controled, phase IV study of local direct     intra-tumor injection of rAd-p53 monotherapy, with concurrent radioactive iodine , or     combination with surgery for treatment of advanced malignant thyroid tumors.   "
232819|NCT00901173|"     Background:        -  Esophageal cancer is the sixth leading cause of cancer deaths worldwide. Two primary          cell types, squamous cell carcinoma and adenocarcinoma, account for most cases. Of the          two, esophageal squamous cell carcinoma (ESCC) accounts for more than 80 percent of all          deaths from esophageal cancer. Many cases occur in certain areas with defined geographic          boundaries, including parts of Kenya.        -  Studies of ESCC in developed countries (such as the United States) suggest that heavy          tobacco and alcohol use, poor diet, and low socioeconomic status are the primary risk          factors. Males and African Americans are also at higher risk. However, these risk          factors do not fully explain the prevalence of cases in several of the identified          geographic areas.        -  ESCC is the most common cancer seen at Tenwek Hospital in western Kenya, and a notable          number of patients are 30 years of age or younger.      Objectives:        -  To test the feasibility of a new protocol by recruiting visitors to Tenwek Hospital and          volunteers from the general population for study purposes.        -  To use the new protocol to obtain blood and urine samples from ESCC cases in Tenwek          Hospital and from nonpatient volunteers.      Eligibility:        -  Hospital patients and volunteers who live within 50 kilometers of Tenwek Hospital in          western Kenya.      Design:        -  All participants will complete a questionnaire and provide blood and urine samples for          testing.             -  The questionnaire will include questions about individual and family medical               history, living conditions, lifestyle, habits, and diet.             -  Blood and urine samples will be collected from all participants after the               questionnaire.        -  Biological samples will be shipped to the United States for further testing.        -  Treatment will not be offered as part of this study.   "
232820|NCT00901186|"     This study will assess the efficacy and safety of ranibizumab (intravitreal injections)     versus laser treatment in patients with visual impairment due to diabetic macular edema.   "
232821|NCT00901199|"     This is a small pilot study looking at the safety of giving combination chelation with Exjade     and Desferal to 15 patients. The hypothesis is that combination chelation is safe in     decreasing overall iron in patients with thalassemia.   "
232822|NCT00901212|"     Heart failure is a major health problem in Canada. Recent advances in medical and device     therapy have helped to reduce the morbidity and mortality of patients with this problem.     Among these treatments, cardiac resynchronization therapy (CRT) has very recently been shown     to be effective to improve functional class, quality of life and exercise tolerance of the     patients with the most severe symptoms of heart failure and a prolonged duration of the QRS     on the 12-lead Electrocardiography (ECG).   "
232823|NCT00901225|"     Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte     colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both     healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via     apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008,     Plerixafor received approval from the Food and Drug administration for use in combination     with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is     not designed to support approval of a new indication or change in the advertising for     Plerixafor. The route of administration and dosage level are identical to that which is     listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins     Lymphoma, there is no known or theoretic increased risk of the use of this drug in this     patient population.      The study hypothesis for this study is that patients with a circulating CD34+ count < 20     cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X     10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.   "
232824|NCT00901238|"     Conventional treatments of retinoblastoma involves laser photocoagulation, cryotherapy     (freezing of the tumor), plaque radiotherapy,external beam radiotherapy, and intravenous     chemotherapy. Enucleation (removing of the eye)is the last option when the tumor cannot be     controlled otherwise. However,many children with retinoblastoma present with advanced     intraocular disease for which enucleation is the only option. Intra-arterial chemotherapy     (Chemosurgery)delivers anti-tumor drug directly into the ophthalmic artery (the artery     feeding the eye) in order to increase the dose of drug reaching the tumor while minimizing     toxicity to the rest of the body.   "
232825|NCT00901251|"     The purpose of this study is to evaluate the reproducibility of over active bladder symptom     score (OABSS) in Asian countries.   "
232826|NCT00901264|"     The purpose of this study is to correlate the results of the MICK assay with short- and     long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in     guiding chemotherapy of cancer patients.   "
232841|NCT00901459|"     The purpose of this study is to investigate the use of repetitive transcranial magnetic     stimulation (rTMS) to block craving for cigarettes in smokers. rTMS is an investigational     procedure, where a device called a stimulator provides electricity to a device that creates     a magnetic field. This device is placed against the scalp in the front of the head so that     the magnetic field is focused on an area of the brain that is thought to be involved in     craving for cigarettes. rTMS is an investigational procedure so therefore being tested in     research studies and is not approved by the U.S. Food and Drug Administration (FDA). Changes     in magnetic fields during rTMS administration change electrical currents which may affect     brain activity and function.   "
232827|NCT00901277|"     The study is a three-arm design where up to 600 patients hospitalized post-MI are recruited     from a large hospital and randomized to either the education group (control group) or one of     the two intervention groups. Patients randomized to one of the intervention groups will     receive a nurse-administered intervention plus the use of Microsoft's HealthVault web-based     platform or solely the use of Microsoft's HealthVault web-based platform and web-based     behavioral intervention, both of which includes a behavioral/medication management component.     The 12 months effects of the intervention will be evaluated.      For baseline and outcome assessments we will obtain BP, nonfasting LDL, and Hb A1c. Patients     will also be surveyed about demographics and health behaviors during the baseline and 12     months. Study personnel serve as a liaison between subjects and their providers; however, all     decisions related to clinical care are ultimately left up to the patient's provider. Subjects     with serious adverse effects will be advised and assisted in seeking emergency medical care.   "
232828|NCT00901290|"     The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the     pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive   "
232829|NCT00901303|"     The primary objective of the study is to determine the progression-free survival [PFS] at 36     months for patients with Hodgkin lymphoma who achieve a complete metabolic response as     demonstrated by a negative fluorodeoxyglucose (FDG)-PET scan after one cycle of ABVD     (adriamycin, bleomycin, vinblastine, dacarbazine) who undergo abbreviated ABVD chemotherapy     (3 cycles).   "
232830|NCT00901316|"     The primary purpose of this study is to determine if adding bleach baths to routine ways for     prevention of Staph infections is helpful. The amount added is a very weak amount. This would     provide a relatively inexpensive method to help prevent recurrent skin infections caused by     the Staph germ. The investigators will also be studying how often Staphylococcus aureus lives     in the nose, throat, and groin area.   "
232831|NCT00901329|"     The purpose of this trial is to study potential differences between two prostheses,     including: feel of prosthesis (i.e., how natural does the prosthesis feel), range of motion     (ROM), pain perception for each prosthesis, satisfaction, patella tracking and quantification     of the removed bone anterior on the femur (weight).   "
232832|NCT00901342|"     This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic     Castrate Resistant Prostate Cancer (CRPC).   "
232833|NCT00901355|"     Introduction: High blood pressure especially systolic hypertension is a common condition in     the elderly and is considered as a major determinant not only of cardiovascular (CV)     morbidity and mortality, but also of several other age-related diseases, frailty and loss of     autonomy. Actually, the association between BP levels and morbidity and mortality in the very     elderly persons with several co-morbidities remains a controversial issue      Objectives: The aim of the PARTAGE study (Predictive values of blood pressure and arterial     stiffness in institutionalized very aged population)is to determine the predictive value of     blood pressure (BP) and arterial stiffness for overall mortality, major cardiovascular events     and cognitive decline in a large population of institutionalized subjects aged 80 and over.      Methods: The population is composed of 1130 subjects aged over 80, living in nursing home,     included by four french university hospitals centre (Nancy, Dijon, Paris, Toulouse) and two     Italian (Cesena, Verona). Subjects with severe dementia and a very low level of autonomy are     excluded from the study During the first visit, blood pressure were measured using an     automatic monitor by physician in sitting and standing position (clinical BP and Orthostatic     BP) and by a self measurement of blood pressure 3 measurements, in the morning and the     evening, during 3 consecutive days).      Arterial stiffness is evaluated by measuring the carotid-femoral and carotid-radial pulse     wave velocity (PWV) with the PulsePen® automatic device. Deaths and cardiovascular events are     recorded during a follow-up of 2 years.      The hypothesis of the PARTAGE longitudinal study is that in very elderly frail individuals     with multiple co-morbidities, CV risk could be better evaluated by combining     self-measurements of BP and direct evaluation of arterial stiffness which are less influenced     by the above mentioned disease and co-morbidities.   "
232834|NCT00901368|"     Double blind, multinational, multicentre, randomised, 2 arm parallel group study   "
232835|NCT00901381|"     The aim of the study is to investigate treatment with Leukostim (Filgrastim;     granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke.   "
232836|NCT00901394|"     The goal of this study is to find out if giving intravenous B-vitamins before general     anesthesia with nitrous oxide prevents the increase in homocysteine, a metabolite that has     been linked to cardiovascular complications.   "
232837|NCT00901407|"     This study is intended to evaluate the efficacy and safety of lamotrigine as an     antidepressant augmentation agent in a sample of individuals with major depression and a     history of both prior non-response and prospective failure to respond to at least one     adequate trial of an antidepressant (for a total of two failed trials).   "
232838|NCT00901420|"     Objectives:      The primary objective of this study is to determine whether bladder compliance is     significantly lower in men who undergo prostatectomy for recurrence following primary     radiation therapy than in men who undergo prostatectomy as primary treatment.      The secondary objective is to examine the quality-of-life items addressed in the UCLA     Prostate Cancer Index for differences between the two populations. The investigators will     also look at secondary objective urodynamic measures, such as bladder capacity, to assess for     a difference.   "
232839|NCT00901433|"     The NAEPP (National Asthma Education and Prevention Program) guidelines recommend that     spirometry be performed on patients with asthma because they serve as an objective measure of     airway obstruction. Unfortunately, most children under 5 years of age are unable to perform a     forced expiratory maneuver making conventional spirometry unavailable in this age group in     most venues. Furthermore, other population groups such as retarded people, elderly or     physically handicapped share the same difficulty.      Karmel Sonix Ltd has developed the Personal WheezoMeter a hand-held pulmonary sounds analyzer     that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence     of wheezing. This usability study was designed to test independent home use and device     interface effectiveness of the Personal WheezoMeter in order to validate its safe and     effective use by intended users.   "
232840|NCT00901446|"     This study is designed to evaluate the technical performance and clinical handling of a     coronary catheter that includes two imaging techniques. The catheter being evaluated performs     near infrared spectroscopy and ultrasound imaging of the coronary arteries. Near infrared     spectroscopy is used to identify lipid or cholesterol deposits in the vessel wall and the     ultrasound component provides structural information about the vessel. Combining multiple     imaging techniques into a single catheter can reduce the total number of catheters required     during treatment and the overall duration of cardiac catheterization. Both of these results     may lead to safer procedures.   "
232854|NCT00894790|"     This Study Will Evaluate Celecoxib Efficacy And Safety Versus Standard Doses Of Diclofenac In     Acute Pain Due To Cervical Injury (Due To A Sprain) Related To A Motor Vehicle Accident   "
232842|NCT00901472|"     The hypothesis of this study is: sleep disordered breathing (SDB), specifically, obstructive     sleep apnea, is associated with poorer glucose in the existing type 2 diabetic condition.      In an exploration of this hypothesis, the investigators hope to provide evidence linking SDB     to increased severity of disease in the type 2 diabetic patient. By doing so, the     investigators ultimately seek to support investigating the use of SDB interventions as an     additional method of care in the treatment of type 2 diabetes.   "
232843|NCT00894647|"     The objective of this study is to evaluate the efficacy and safety of imiquimod cream versus     placebo cream when used after cryosurgery in the treatment of actinic keratoses (AKs).   "
232844|NCT00894660|"     The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is     pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).   "
232845|NCT00894673|"     The objective of this study is to verify, through a randomized, single-blind, multicentre,     parallel and comparative study, the effectiveness of heparin sodium of porcine origin in     patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through     the control of hemostasis during and after surgery, based on the strengths of markers of     coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding)     at the end of the surgery.   "
232846|NCT00894686|"     The main purpose of this study is to assess the seropersistence of TBE virus antibodies in     children, adolescents and young adults who received the first booster vaccination with either     FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.   "
233049|NCT00904319|"     Knee Osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is     one of the most disabling problems facing the growing population of older adults. The purpose     of this research is to reduce disablement of older adults with symptomatic knee     osteoarthritis.   "
232848|NCT00894712|"     The investigators plan to investigate the protective effects of topical     sulforaphane-containing broccoli-sprout extracts (BSE) on radiation-induced dermatitis in     women undergoing external-beam radiation therapy for breast cancer. Topical sulforaphane     induces phase 2 enzymes that are protective against oxidants, electrophiles, and inflammation     (Talalay and Fahey, 2001) - all of which are generated by both ultraviolet and ionizing     radiation. Previous work from the investigators' group demonstrated that sulforaphane     treatment protects against ultraviolet radiation-induced erythema of human skin (IRB protocol     NA_00004897; Talalay et al. 2007). This investigation will extend the investigators' previous     work by employing ionizing rather than ultraviolet radiation.      The investigators propose a two part sequential protocol (Study A and Study B). Both studies     will involve women with breast cancer who have undergone lumpectomy and are scheduled for     adjuvant external beam radiation treatment. In study A, the investigators will validate their     technique for measurement of skin erythema using a device called a chromometer; no active     agent will be applied (up to 6 women). Study B will follow completion of Study A. Study B     will involve the application of broccoli sprout extracts (BSE) or vehicle alone to determine     if sulforaphane can reduce radiation-induced erythema (27 women). Four adjacent, 1.5-cm     diameter areas-of-interest on the affected breast will be located by means of an adhesive     vinyl template which can be accurately and repeatedly placed at the same position. Two of the     four areas will be treated with BSE (active agent) and two with vehicle (inactive control).     BSE will be applied on three days weekly throughout the 5-week period of whole breast     radiation. Erythema will be noninvasively quantified by measuring the red-reflectance of the     skin with a chromometer up to three times weekly throughout treatment. A total of 33 patients     are to be enrolled.      The investigators' objective is to determine and quantify the effect of topical BSE on     radiation-induced skin erythema. This study will employ standard, clinically-accepted     radiation doses and techniques that are safe and well tolerated. The safety and tolerability     of both oral and topical broccoli sprout preparations is well established; no safety concerns     have been noted. (Shapiro et al. 2006; Dinkova-Kostova et al. 2007).   "
232849|NCT00894725|"     The main goal of this study is to clarify if laparoscopy (LPS) could become the standard     approach in patients undergoing left colonic resection.      268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or     open (n=134) approach. Postoperative care protocol was the same in both groups. Trained     members of the surgical staff who were not involved in the study registered 30-day     postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term     morbidity, quality of life, and 5-year survival have also been evaluated.   "
232850|NCT00894738|"     The proposed study aims to begin the multi-step process of establishing the reliability and     validity of hepatic triglyceride content (HTGC) and carotid artery intima-media thickness     (IMT) as biomarkers of cardiometablic risk in children treated for mental illness. The     distribution of HTGC and carotid IMT—proximate indicators of cardiometabolic risk—across a     range of dual-energy X-ray absorptiometry (DEXA)-measured adiposity in children treated with     antipsychotic agents will be characterized in comparison to healthy, untreated,     non-psychiatric controls, in order to estimate effect sizes for future studies incorporating     these markers. The ability of HTGC and IMT to predict cardiometabolic risk as measured by     commonly-used laboratory tests, such as fasting lipids, liver function tests, C-reactive     protein and serum fibrinogen, will be assessed.   "
232851|NCT00894751|"     The goal of this study is to determine if there is a significant difference in the quality of     care between the investigators' two standard anesthesia techniques for children undergoing a     MRI of the body and/or extremity MRI. Quality of care will be measured by time spent in the     MRI room as well as parental satisfaction, frequency of interruptions of the MRI scan,     incidence-severity of respiratory complications, post anesthesia agitation, and time spent in     the induction room, MRI room, and Post-Anesthesia Care Unit (PACU).   "
232852|NCT00894764|"     This study will follow 1000 refugee infants from birth for two years. The aim of the study is     to better understand why some children develop infections caused by the bacterium     Streptococcus pneumoniae whilst others merely carry this organism asymptomatically at the     back of the nose (in the nasopharynx). The investigators will also define which     micro-organisms cause lower respiratory tract infections (e.g., pneumonia) in this population     in order to implement appropriate interventions (e.g., vaccines). Infants will be reviewed     monthly and a nasopharyngeal swab will be taken. A group of 250 mother-infant pairs will be     studied in greater detail, to improve our understanding of the frequency and outcomes of     nasopharyngeal carriage of Streptococcus pneumoniae. Monthly nasopharyngeal swabs will be     collected from mothers and infants. The investigators will measure the infant immune response     to Streptococcus pneumoniae carriage or disease by taking monthly blood samples. The     investigators will make an assessment of the protective effect of antibodies acquired from     the mother during pregnancy by taking blood from the mother and placenta at birth. An     assessment of pneumococcal carriage in mothers will also be made to determine how frequently     the bacterium is transmitted between family members. All lower respiratory tract infections     will be documented, and the causative micro-organisms identified.   "
232853|NCT00894777|"     This is an observational, naturalistic, multicenter, retrospective study to describe the     therapeutic management of patients with moderate and severe psoriasis under treatment with     topical and/or systemic drugs in usual clinical practice in Spain.   "
232856|NCT00894816|"     During the period of 2000-2003, 179 healthy, term infants with no previous signs of allergic     disease were recruited and randomized to daily intake of cereals with or without the addition     of Lactobacillus paracasei subspecies paracasei strain F19 (LF19) from 4-13 months of age.     The effects of LF19 on gut microbial composition, infections, allergies, immunological     development, growth and blood lipids were monitored. Of 179 included infants, 171 completed     the study. The study product was well tolerated with no observed side effects. Compliance was     excellent.      In a follow-up study, the aim is to investigate the long-term effects of feeding LF19 during     weaning on allergies, immune programming, overweight, gut microbial composition and oral     health in 8-year old children.      The investigators' primary outcome will be to determine whether daily intake of LF19 during     weaning results in less eczema at 8 years of age, and if the preventive effect encompasses     also respiratory allergies and immunoglobulin E (IgE) - sensitization. The long term effects     on gut microbial composition, overweight and metabolic markers will be investigated.     Furthermore, the possible preventive effects of LF19 on caries will be assessed.   "
233076|NCT00904670|"     The objective of this study was to establish that an optimal dose of Quillivant XR oral     suspension would result in a significant reduction in signs and symptoms of ADHD compared to     placebo treatment in pediatric patients ages 6-12 years with ADHD.   "
232857|NCT00894829|"     The objective of this study is to verify, through a randomized, single-blind, multicentre,     parallel and comparative study, the effectiveness of heparin sodium of porcine origin in     patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through     the control of hemostasis during and after surgery, based on the strengths of markers of     coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding)     at the end of the surgery.   "
232858|NCT00894842|"     The purpose of this study is to determine whether pregnenolone will demonstrate significant     improvements in cognitive functioning and negative symptoms compared to patients receiving     placebo.   "
232859|NCT00894855|"     This study was an evaluation of the Dana-Farber Cancer Institute Blum Family Resource Center     Van's existing skin cancer screening and education program. This program occurred over 2     summers. This study will fill a critical gap in the investigators' knowledge about how best     to address the high-risk behaviors that regularly occur during the summertime at beaches. The     investigators randomized beaches to receive different combinations of the van program     components in order to determine how services should optimally be configured to maximize     impact. The investigators hypothesized that providing all three components (1-Skin cancer     prevention education; 2-Biometric feedback using a Dermascan Analyzer that illustrates skin     damage due to sun exposure and Ultra Violet (UV) Reflectance Photography; and 3-Dermatologist     skin exam) will maximize knowledge and behavior change, relative to education alone.   "
232860|NCT00894868|"     This study will assess the effect of vildagliptin on left ventricular function in patients     with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and     overall safety and tolerability will also be assessed.   "
232861|NCT00894881|"     The Effect of Gut Cleaning as a Preparation to Colonoscopy on resting energy expenditure     (REE).   "
232862|NCT00894894|"     Multicenter, open-label, dose-ranging study in two parts: maximum tolerated dose (MTD)     segment (the first 28-day course of MP 470) followed by long-term safety segment.      MTD segment: follows standard oncology phase-I design; within-patient dose level adjustments     prohibited; each patient participates in one of three stages:        1. Accelerated Titration Stage        2. Dose Escalation/De-Escalation Stage        3. Dose Confirmation Stage   "
232863|NCT00894907|"     Acute pancreatitis (AP) is a common disorder with rising incidence varying between 35 and 80     per 100,000 in Europe and the USA. About 15% of patients develop necrotizing pancreatitis     (NP) with a mortality of up to 42% and frequently prolonged hospitalisation in the survivors.     Despite a fulminant pathophysiology comparable to that of sepsis, the management of NP is     still re-active, symptomatic and mainly based on paradigms with low grade evidence. In sepsis     beneficial effects of early goal-directed fluid resuscitation resulting in reduced mortality     have been clearly shown. With regard to these data and several studies of NP demonstrating     the deleterious effects of fluid loss and haemoconcentration within the first 24h after     admission, early goal-directed fluid resuscitation has the potential of improving outcome     also in NP. Therefore, it is the aim of this RCT to demonstrate beneficial effects of early     goal-directed resuscitation using an algorithm based on modern haemodynamic parameters such     as Intra-thoracic Blood Volume Index (ITBI), Extravascular Lung Water Index (ELWI) and Stroke     Volume Variation (SVV) which can be easily and safely obtained due to recent progress in     haemodynamic monitoring. The algorithm is aimed at maintaining adequate resuscitation (ITBI,     SVV) as well as preventing pulmonary over-hydration (ELWI).The use of a similar algorithm in     cardiac surgery patients resulted in a significant reduction in catecholamine use, lactate     levels, duration of ventilation and ICU stay.   "
232864|NCT00894920|"     The purpose of this study is to estimate the number of pregnant women who, during pregnancy,     have low levels of the vitamin biotin. The hypothesis of this study is that a large number of     pregnant women will have low biotin levels. This information will be used to later determine     if low biotin levels during pregnancy cause certain birth defects.   "
232865|NCT00894933|"     1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and          complications associated with the Device following a radical prostatectomy.        2. To verify CONTINUUM™ device performance using updated CONTINUUM™ device design          modifications, physician procedure guide and training methodology.   "
232866|NCT00894946|"     The hypothesis of this study is that Lipiodol uterine bathing improves the success rate of in     vitro fertilization (IVF) for women with endometriosis or recurrent IVF implantation failure.   "
232867|NCT00894959|"     The objective of this study is verify, through a randomized, single-blind, multicentre,     parallel and comparative study, the effectiveness of heparin sodium of porcine origin in     patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through     the control of hemostasis during and after surgery, based on the strengths of markers of     coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding)     at the end of the surgery.   "
232868|NCT00894972|"     The proposed study will be a randomized clinical trial designed to determine the most     effective physical therapy program for individuals who have undergone lumbar discectomy     surgery. The study will compare two different post-operative physical therapy programs     (general strengthening or general + specific strengthening). Both groups will begin treatment     2 weeks post-surgery. Subjects in both groups will receive weekly treatment sessions for 8     weeks with a treatment program emphasizing exercises shown to activate the large trunk     muscles without imposing potentially harmful compression or shear forces. The general +     specific strengthening group will also receive exercises shown to isolate activation of the     deep trunk muscles, in particular the multifidus, with training augmented by the use of     diagnostic ultrasound biofeedback. Patient assessments will be conducted pre- and     post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.   "
232869|NCT00894985|"     The objective of this study is to verify, through a randomized, open, multicentre, parallel     and comparative study, the effectiveness of heparin sodium of porcine origin in patients     undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the     control of hemostasis during and after surgery, based on the strengths of markers of     coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding)     at the end of the surgery.   "
233624|NCT00915330|"     The purpose of this study is to determine whether rapid on-site cytopathologic evaluation     (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the     diagnosis of hilar and mediastinal lymphadenopathy.   "
232870|NCT00894998|"     The objective of this study is to verify, through a randomized, single-blind, multicentre,     parallel and comparative study, the effectiveness of heparin sodium of porcine origin in     patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through     the control of hemostasis during and after surgery, based on the strengths of markers of     coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding)     at the end of the surgery.   "
232871|NCT00895011|"     The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil     in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing     radical prostatectomy.   "
232872|NCT00895024|"     The Objectives are to administer the Family Evaluation of Hospice Care (FEHC) questionnaire     and The Texas Revised Inventory of Grief (TRIG) to caregivers previously enrolled into the     parent grant and conduct supplemental analyses to:        1. examine cross-ethnic differences in the caregivers' quality of hospice care assessments.        2. investigate the association between parenteral hydration status of the patient and the          quality of care assessments provided by the caregivers after death.        3. examine the association between levels of grief (as measured by the TRIG) and the          quality of hospice care assessments provided by the caregiver.   "
232873|NCT00895037|"     The purpose of this observational study is to describe the incidence of adverse events among     patients treated with Refacto AF in usual health care settings in Germany and Austria.   "
232874|NCT00895050|"     The primary purpose of this study is to evaluate a computer-based tool on the clinical     management of patients with rheumatoid arthritis in Spain.   "
232875|NCT00895063|"     Studies have suggested that voluntary muscle exercise in the hand and face after botulinum     toxin injection may enhance the clinical effects of the toxin. Exercise may speed up the     absorption of the toxin by the nerves and enhance the clinical response. This study will     explore the effect of exercise on botulinum toxin injections for spasmodic dysphonia (SD).   "
232876|NCT00895076|"     The primary objectives are to evaluate the extent of systemic exposure and dexamethasone     bioavailability following a single application of a dexamethasone iontophoretic transdermal     patch in healthy volunteers.      The secondary objectives are to evaluate the systemic and topical safety of the dexamethasone     iontophoretic transdermal patch and of the dexamethasone intramuscular (IM) injection.   "
232877|NCT00895089|"     This clinical trial compares the use of moxifloxacin versus ceftriaxone in the treatment of     primary pyogenic liver abscess. The trial will include nonpregnant adults presenting with     primary liver abscess based on clinical diagnosis and computed tomography. The trial aims to     determine whether the use of moxifloxacin can effectively treat primary pyogenic liver     abscess and shorten hospitalization. This regimen has the additional benefit of avoiding     nephrotoxic agents, such as aminoglycosides, used frequently in treatment of pyogenic liver     abscess. Development of antibiotic resistance to colonized bacteria in the gastrointestinal     tract will also be evaluated using stool cultures.   "
232878|NCT00895102|"     The purpose of this study is to determine the bioavailability, pharmacokinetic and safety     profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy     volunteers.   "
232879|NCT00895115|"     RATIONALE: Vitamin E supplements may stop or delay the development of prostate cancer in     patients who are at risk of prostate cancer or who have prostate cancer. It is not yet known     which vitamin E regimen is more effective in preventing prostate cancer.      PURPOSE: This randomized phase I trial is comparing vitamin E supplement regimens to see how     well they work in preventing cancer in patients at risk of prostate cancer or who have     prostate cancer.   "
232880|NCT00895128|"     The goal of this clinical research study is to find the highest tolerable dose of Tarceva     (erlotinib hydrochloride) that can be given in combination with Sprycel (dasatinib). The     safety of this drug combination will also be studied.   "
232881|NCT00895141|"     The purpose of the study is to test whether increased saturated fat intake results in     increased levels of larger LDL and HDL particles in individuals with LDL Pattern B.   "
232882|NCT00895154|"     The overall goal of this project is to determine the feasibility of conducting a cognitive     intervention for children with sickle cell disease.   "
232883|NCT00895167|"     Heme oxygenase 1 (HO-1) serves as a protective gene. Induction of HO-1 has therapeutic     potential for several indications. The inducibility of HO-1 by curcumin will be evaluated in     this pilot study. Furthermore, the influence of a modulating factor of HO-1 gene activity on     the dinucleotide guanosine thymine repeat (GT) length polymorphism in the promotor region     will be investigated.   "
233323|NCT00909584|"     This is a multicenter Phase 2 randomized parallel-group study to determine the effect of     Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or     enter an observation period with an option to crossover to Telintra treatment in a 1:1     allocation.   "
232884|NCT00895180|"     RATIONALE: Monoclonal antibodies, such as ramucirumab and anti-PDGFR alpha monoclonal     antibody IMC-3G3 (Olaratumab), can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them.      PURPOSE: This phase II trial is studying how well ramucirumab or anti-PDGFR alpha monoclonal     antibody IMC-3G3 works in treating patients with recurrent glioblastoma multiforme.   "
232885|NCT00895193|"     Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However,     use of niacin is limited due to incidents of flushing which limits its acceptability. Some     information suggests that applesauce can reduce the incidence and severity of flushing. The     apple pectin in particular is thought to be the ingredient that affects this reaction. To     determine if the apple pectin does affect flushing from niacin, the investigators will study     the affects of isolated apple pectin in pill form. The investigators plan on recruiting 100     patients, and giving them 1000 mg of Niacin to induce flushing. Patients will be divided into     4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo.     Incidents and severity of flushing will be monitored for up to 6 hours post Niacin ingestion.   "
232886|NCT00895206|"     This study is an open, randomised trial in which one group of patients (control) will receive     the golden standard therapy and the other group (treatment) will receive individually adapted     immunosuppression.   "
232923|NCT00901810|"     Accurate length determination of root canal is essential in root canal therapy. Radiography     has been the conventional method for this measurement but recently several in-vitro studies     have shown that new generations of Electronic Apex locators are as accurate as radiography in     length determination. It is hypothesized that the latest generation of Electronic Apex     locator can produce acceptable results as radiography when used for length determination.   "
232887|NCT00895219|"     Traditionally, the physiotherapy management of people with dysfunctional breathing or     hyperventilation syndrome is breathing re-training. There is increasing clinical evidence     that structural and functional changes develop in the muscles and connective tissues of the     chest wall, abdomen and back when the upper chest accessory pattern of breathing is used over     time. When treatment includes breathing techniques only it is difficult for a person with     chronic hyperventilation, who has developed muscle and connective tissue changes, to revert     to using the normal lower chest diaphragmatic breathing pattern. In clinical practice when     the problems which have developed in the musculoskeletal system are addressed, the patient     reverts more quickly to the lower chest pattern of breathing but there is as yet little     evidence to support this clinical finding.   "
232888|NCT00895232|"     Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS     were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron     sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The     second cohort received two 500 mg IV iron sucrose infusions in 500mL of NSS administered over     four to six hours on two separate dates, separated by two to seven days. The third cohort     received two 500 mg IV iron sucrose infusions in at least 500 mL of NSS over six hours within     30 hours of the start of the first infusion. Cohorts were enrolled and treated subsequently.   "
232889|NCT00895245|"     RATIONALE: Fosaprepitant dimeglumine, palonosetron hydrochloride, and dexamethasone may help     lessen or prevent nausea and vomiting caused by cisplatin in patients with head and neck     cancer undergoing chemotherapy and radiation therapy.      PURPOSE: This phase II trial is studying how well fosaprepitant dimeglumine together with     palonosetron hydrochloride and dexamethasone works in preventing nausea and vomiting caused     by cisplatin in patients with stage III or stage IV head and neck cancer undergoing     chemotherapy and radiation therapy.   "
232890|NCT00895258|"     This study will compare the efficacy of two types of supportive treatments for a program     called Individual Placement and Support, which helps people with severe mental illnesses find     and keep jobs.   "
232891|NCT00895271|"     Background:        -  National Institutes of Health (NIH) researchers have been studying immune cells (white          blood cells) to better understand how the human body s defense system works and adjusts          or regulates itself, and how changes in this system can make a person sick.        -  To study the cells of patients who have problems with their immune systems, researchers          would like to collect samples of skin cells from patients with immune system disorders          and compare them with skin cells taken from healthy volunteers. By studying these cells,          researchers hope to determine whether these cells can be modified to create a new kind          of personalized gene therapy that would attempt to cure immune diseases in the future.      Objectives:        -  To obtain skin cells from patients with immune system disorders and from healthy          volunteers for research and comparison purposes.      Eligibility:        -  Patients between the ages of 2 and 85 who have immune system disorders.        -  Healthy volunteers between the ages of 18 and 85.        -  Both groups will be selected from the eligible participants of existing NIH studies into          immune system disorders.      Design:        -  Researchers may take up to two biopsies from participants arms, legs, abdomen, or back.        -  The biopsy site will be numbed with local anesthetic and cleaned before the sample is          taken.        -  The punch skin biopsy needle will be inserted into the skin and rotated to remove a          small circle of skin (approximately 1/4 to 3/8 of an inch across). The area will be          closed with bandages or stitches, and then covered with a dressing. Any stitches will be          removed in 7 to 10 days.        -  Tissue samples collected in the study will be stored for future research.   "
232892|NCT00895284|"     Robotic technology has been used for laparoscopic hysterectomies for over 10 years. Mayo     Clinic Arizona has used robotics in Gynecology for the last 10 years with well over 500     procedures performed. Similar to the laparoscopic approach, small incisions are utilized with     the robotic approach. Robotic instruments differ from laparoscopic instruments in that the     tips of the instruments can rotate more like the human wrist. The instruments are attached to     the robotic arms which are controlled by your surgeon. The surgeon is seated at the surgeon's     console which is located 12 feet from the patient while the surgical assistant is at your     bedside assisting in the procedure.      This study is being done to compare the procedure times and results after laparoscopic     hysterectomies to laparoscopic hysterectomies performed with robotic assistance.   "
232893|NCT00895297|"     This is a phase II efficacy (indicates the capacity for beneficial change or therapeutic     effect) and safety study of Dasatinib in patients with relapsed Chronic Myeloid Leukemia     (CML) following a Stem Cell Transplant (SCT) and who are not benefiting from other treatment,     such as imatinib therapy.      A relapse is when an illness that has seemed to be getting better, or to have been cured,     comes back or gets worse again.      A total of 50 patients ≥18 years of age will be registered on the trial.   "
232894|NCT00895310|"     The purpose of this study is to test the safety of ketoconazole and how well it works after     chemotherapy has been used. Ketoconazole at lower doses has been used for fungal infections     however has not yet been approved by the Food and Drug Administration for use in prostate     cancer. Ketoconazole has been used for many years at high doses for prostate cancer, and this     study will be to look at use of lower dose ketoconazole after someone has received     chemotherapy. Ketoconazole works by halting the production of steroids in your body,     including testosterone, and is thought to work directly on prostate cancer cells in published     lab studies.   "
232895|NCT00895323|"     RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may     help find colorectal cancer cells and learn the extent of disease.      PURPOSE: This phase I trial is studying how well a bispecific antibody works in finding tumor     cells in patients with colorectal cancer.   "
232907|NCT00901589|"     The study is a randomised placebo controlled double-blinded clinical trial where a group of     healthy pre- and postmenopausal women is randomised to the intake of fish oil capsules or     placebo oil capsules for 12 weeks. Anthropometric measurements(weight, height,blood pressure)     blood samples and adipose tissue biopsies will be taken in order to illustrate the effect of     marine n-3 PUFAs (fish oil) on the concentration of circulating female hormones and to     investigate what impact menopause might have on the ability to incorporate marine n-3 PUFAs     into tissues.   "
232896|NCT00895336|"     Abstract:      Current evidence suggests that the enteric flora is the primary trigger for chronic mucosal     inflammation in the Inflammatory Bowel Diseases (IBD), Crohn's Disease (CD) and Ulcerative     Colitis (UC). Studies using probiotic administration to modify the flora for either induction     or maintenance of remission in IBD have had mixed results. Whether probiotics may exert an     anti-inflammatory effect in IBD is not known. The investigators hypothesize that daily     administration of a probiotic, Lactobacillus GG, for four weeks will reduce objective markers     of mucosal inflammation in pediatric UC patients. The investigators will enroll 20 UC     patients in remission or with mild disease activity. These patients will have a one month     period of observation without intervention. They will then receive Lactobacillus GG     (Culturelle), 1010 CFU by mouth twice a day for four weeks (28 days). At baseline and Day 28,     and at day 56 clinical disease activity will be measured using the Pediatric UC Activity     Index (PUCAI), a blood sample for determination of circulating granulocyte pSTAT3+ activation     will be obtained, and a stool sample for determination of fecal calprotectin will be     obtained. In addition, =the investigators will sample subject saliva to determine salivary     glycan phenotype as a surrogate marker of changes of mucosal glycan expression in response to     probiotic administration. The investigators anticipate that both circulating granulocyte     pSTAT3+ activation and fecal calprotectin, as established biomarkers of colonic inflammation,     will be reduced in subjects who receive Lactobacillus GG. Completion of the proposed studies     will determine whether Lactobacillus GG reduces mucosal inflammation in pediatric UC, and     will provide information to design a larger randomized trial.      The investigators' study design is novel in that it is the first probiotic study in children     with UC and it will measure outcomes utilizing the biomarkers fecal calprotectin and pSTAT3+     circulating granulocytes.   "
232897|NCT00895349|"     The purpose of this trial is to improve the clinical management and outcome of patients with     locally advanced cervical cancer by using positron emission tomography-computed tomography     (PET-CT) imaging.      There is considerable debate worldwide regarding the utility of PET for staging cervical     cancer. Although there are studies on the accuracy (sensitivity and specificity) of PET in     cervical cancer, there are currently no prospective randomized studies on how PET information     affects treatment decisions and outcomes.   "
232898|NCT00895362|"     The goal of this clinical research study is to find the highest tolerable dose of Tarceva     (erlotinib hydrochloride) that can safely be given in combination with Erbitux (cetuximab).     The safety of this drug combination will also be studied.   "
232899|NCT00901485|"     The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive     ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal     hypoventilation who have never experienced nocturnal, home NIV.   "
232900|NCT00901498|"     The purpose of this study is to assess the bioavailability of four experimental formulations     relative to the current reference formulation used in the Phase 2 study.   "
232901|NCT00901511|"     The investigators designed an experimental, randomized by parallel groups, stratified     according to previous treatment, open-label study evaluating the superiority of the     combination of whole lung lavage/inhaled GM-CSF versus whole lung lavage alone in patients     with pulmonary alveolar proteinosis. The primary efficacy objective is the total resolution     of the pulmonary involvement. PAP patients matching the enrolment criteria will enter the     study. If requiring the first WLL, they will be randomized to receive WLL (1st level control     group) or WLL/followed by inhaled GM-CSF, according to an acute (12 weeks) followed by     maintenance (6 months) schedule (1st level treated group).   "
232902|NCT00901524|"     The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment     (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.   "
232903|NCT00901537|"     The standard of care for head and neck and lung cancer includes chemotherapy, radiation and     surgery. For patients with cancer of head and neck or lung that recurs after surgery and/or     radiation, or has spread to other parts of body, chemotherapy using cisplatin can slow down     tumor growth and extend lifespan.      The study drug, azacitidine, can block the ability of some cancer cells to replicate, and has     been approved by the Food and Drug Administration for use in myelodysplastic syndrome, which     is a slowly developing blood cell-related cancer. In laboratory and animal experiments using     head and neck and lung cancer cells, azacitidine has been shown to be a cisplatin helper,     (that is, it makes cisplatin more effective in stopping the growth of head and neck and lung     cancer. )      Since the combination of azacitidine and cisplatin has not been used in patients with head     and neck or lung cancer, the investigators are performing this study combining azacitidine     and cisplatin to find out what effects, good and/or bad, the study drug may have on patients     with advanced head and neck or lung cancer. The investigators are doing this study because     they would like to find a better treatment for these types of cancer.   "
232987|NCT00903474|"     RATIONALE: Mindful movement is a self-directed activity of mindfulness (intention, attention,     and attitude) and physical movement. A mindful movement program may be effective in improving     well-being in older women who are breast cancer survivors.      PURPOSE: This randomized clinical trial is studying how well a mindful movement program works     in improving quality of life in older female breast cancer survivors.   "
232904|NCT00901550|"     The purpose of this study is:        1. To ascertain whether the quantitative assessment of enhancing synovial volume and          perfusion indices on serial Magnetic Resonance Imaging (MRI) examination are useful          indicators of responsiveness to treatment in early Rheumatoid Arthritis (RA) using          biologic therapy and Methotrexate (MTX) compared with Methotrexate(MTX) alone.        2. To assess the cost-effectiveness of Tumor Necrosis Factor (TNF) blockers compared with          Methotrexate(MTX) monotherapy for Rheumatoid Arthritis(RA).   "
232905|NCT00901563|"     Hypothesis - Rotigaptide will improve endothelial function in the context of endothelial     dysfunction.      The lining of blood vessels (endothelium) can react to hormones in the blood stream causing     the blood vessel muscle to relax (vasodilatation) and allow more blood to flow. The nitric     oxide and prostacyclin pathways are well documented in this process. However, evidence points     to the existence of a third powerful relaxant called endothelium derived hyperpolarising     factor (EDHF) but its identity and mechanism of action have proved elusive. As well as     causing blood vessels to relax and more blood to flow, EDHF may be involved in the     endothelium signaling, triggering release of a specialised clot dissolving factor called     tissue plasminogen activator (t PA). t PA is important to ensure small clots, which are     constantly being formed in the circulation, are rapidly dissolved and do not grow large     enough to cause heart attacks and strokes.      Evidence points towards the requirement for 'gap junctions' in the mediation of EDHF     responses. Gap junctions are specialised pores which allow small molecules and charge to pass     between cells. They are found between endothelial cells and the underlying muscle of the     blood vessel. A drug called Rotigaptide has been developed to cause gap junctions to open. It     has been safely administered in healthy volunteers and is now in a Phase II drug trial. By     opening gap junctions the investigators hypothesise that it could increase EDHF mediated     activity and vasodilatation. It represents a useful tool with which to examine the role of     gap junctions in EDHF activity in vivo.      Previously the investigators have demonstrated that rotigaptide does not contribute to     endothelial function in healthy volunteers. The investigators now wish to examine the effect     of rotigaptide in conditions of endothelial dysfunction. By limiting the blood flow to the     arm for 20mins the ability of the blood vessel to vasodilate is impaired. By administering an     intra−arterial rotigaptide infusion the investigators want to assess any functional     preservation.   "
232906|NCT00901576|"     This is a drug-drug interaction study; the purpose of this study is to examine the     pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and     Concerta (methylphenidate HCl) when given alone, and in combination.   "
233001|NCT00903682|"     The purpose of this study is to compare the neuropsychiatric adverse event profiles of     etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2     N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability     and efficacy of both treatment arms will be assessed throughout the study.   "
232908|NCT00901602|"     Streptococcus pneumoniae (pneumococcus) is a bacterium that causes severe infections in     children and adults such as meningitis, pneumonia, and blood stream infection. There are many     types of these bacteria defined by the type of sugar coat that they have. These are     classified as serotypes. There are common serotypes that cause severe disease and are     preventable by vaccination of children. Other less common types are more difficult to     prevent. The investigators aim to determine the serotypes that cause invasive pneumococcal     disease in Lebanon and to study their sensitivity to different antibiotics. The investigators     will collect bacterial isolates from different hospitals in Lebanon isolated from the blood     or spinal fluid of patients with invasive pneumococcal disease. This information will help     the investigators determine the usefulness of available pneumococcal vaccines in preventing     these infections. The data will be distributed to all primary care physicians treating     children in Lebanon and will be shared with the Ministry of Health.   "
232909|NCT00901615|"     The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid)     when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin,     vincristine and prednisone).   "
232910|NCT00901628|"     The purpose of this study is to determine whether periarticular multimodal drug injection     (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for     whom contemporary pain control protocols using the continuous femoral nerve block,     intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We     hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer     and would provide better functional recovery and patient satisfaction. We also hypothesized     that the incidence of side effects and complications of the PMDI would be similar to the     No-PMDI.   "
232911|NCT00901641|"     The purpose of this study is to investigate the effect of computerized, home-based cognitive     training on sleep quality of older adults with insomnia.   "
232912|NCT00901654|"     The purpose of this study is to evaluate the safety and immune response to ACE527.   "
232913|NCT00901680|"     To establish a multidisciplinary research structure for tissue repository that facilitates     projects that bridge specialties that normally may or may not interact.   "
232914|NCT00901693|"     The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic     Solution for the treatment of adenoviral conjunctivitis.   "
232915|NCT00901706|"     This study is designed to assess the best method for caring for elders reported to Adult     Protective Services (APS) for self-neglect. Specifically, this study will compare APS usual     care coupled with interdisciplinary comprehensive geriatric care to APS usual care alone in     improving the health and quality of live among elders with substantiated self-neglect.   "
232916|NCT00901719|"     The apelin-APJ system is a relatively new discovery. It has generated interest in part due to     it's apparent ability to counteract the renin-angiotensin system, which is frequently     overactive in many cardiovascular disease.      Two of the main actions of apelin are to increase the pumping ability of the heart and cause     blood vessels to relax. The investigators wish to assess if these actions are altered in the     setting of normal renin-angiotensin activation and increased renin-angiotensin activity.   "
232917|NCT00901732|"     Patients who have been diagnosed with a head and/or neck cancer commonly develop oral     mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to     evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral     intake, swallowing function and pain.   "
232918|NCT00901745|"     The apelin-APJ system is a relatively new discovery. It has generated interest in part due to     it's apparent ability to counteract the renin-angiotensin system, which is frequently     overactive in many cardiovascular disease.      Apelin has the ability to cause blood vessels to relax, increasing their diameter and hence     blood flow down the blood vessel. The researchers wish to investigate the hypothesis that an     infusion of apelin will reduce the effects of angiotensin II, which is know to reduce the     diameter of blood vessels.   "
232919|NCT00901758|"     Breech presentations (where a baby presents with feet or bottom down) have an increased risk     of perinatal and neonatal complications, and are usually delivered by cesarean section. As an     alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the     baby so that it is head down: this manoeuvre is called an external cephalic version (ECV).      Drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ECV success     rates. Nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested     as an agent to help ECV. There is some suggestion that nitroglycerin may be more helpful in     women who have not previously been pregnant (nulliparous women) than in women who have been     pregnant more than once (multiparous women), and so we have planned two trials.      This study is designed to answer the following questions for multiparous women:      Will administration of IV nitroglycerin for uterine relaxation improve ECV success rates?     Will an increase in ECV success result in a decreased cesarean section rate?   "
232920|NCT00901771|"     The primary objective of the proposed investigation is to evaluate the efficacy of the     Provent device in a sample of OSA patients who have either refused or been non-adherent with     PAP treatment. Both initial efficacy (evaluated after approximately one week with Provent)     and efficacy after approximately 5 weeks in patients who demonstrate initial efficacy will be     assessed. A secondary objective is to assess adherence with Provent treatment during the     5-week evaluation period.   "
232921|NCT00901784|"     The objective of this study was to compare the single-dose relative bioavailability of     Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg     dose under fasting conditions.   "
232922|NCT00901797|"     Study Title: Arthroscopic rotator interval closure in shoulder instability repair - a     prospective study      Objective: To evaluate the effect of arthroscopic rotator interval closure (ARIC) on patients     with recurrent shoulder dislocations undergoing arthroscopic bankart repair (ABR) in terms of     recurrence, rehabilitation and function.      Hypothesis:        1. Although Hyperlax patients undergoing ABR have higher incidence of recurrent shoulder          dislocations than those without hyperlaxity, adding ARIC will lower the recurrent          dislocation rate.        2. Patients with arthroscopic bankart repair (ABR) and ARIC are slower in gaining the range          of motion (ROM) but within 6 months are equal to those with ABR only.   "
232924|NCT00902616|"     Patients with diabetes have dysfunction of the lining of the arteries which lead to impaired     circulation in the small blood vessels. This is thought to be secondary to reduced chemicals     in the blood viz: nitric oxide. This chemical is derived from an amino acid (protein)     L-arginine. Therefore, the researchers investigated whether giving patients L-arginine     (versus dummy powder) would improve the blood flow in the small blood vessels in the lower     limbs of patients with damage to their nerves (neuropathy).   "
232925|NCT00902629|"     The goal of this randomized clinical trial is to investigate when it is optimal to treat the     eye disease epiretinal fibrosis.      Hypothesis: In a population of patients with symptomatic idiopathic epiretinal fibrosis and     visual acuity above 0.4, the best long term outcome measured by visual acuity is achieved by     early surgery compared to periodic controls until a continual loss of visual acuity has been     ensure followed by surgery.   "
232926|NCT00902642|"     The goal is to acquire more in-depth knowledge on physical therapists' attitudes towards and     beliefs about psychosocial factors in back pain, how physical therapists integrate     psychosocial factors into their clinical practice and the effects of a training program for     physical therapists in psychosocial factors on clinical practice and thereby on patient     outcome in terms of disability, pain, catastrophizing, and treatment satisfaction.   "
232927|NCT00902655|"     Nocturia is defined as waking one or more times to void during the period between going to     bed with the intention of sleeping and waking with the intention of arising.The     pathophysiology of nocturia is multifactorial and can be complex. Therefore it is important     to adopt a systematic approach to identify the possible causal factors of nocturia and to     treat them accordingly. Patients with nocturia can be categorized as having one of the     following three disorders: (1) nocturnal polyuria (NP) in which the voided urine volume     during the hours of sleep exceeds 35% of the 24-hr output, (2) low nocturnal bladder capacity     (NBC) causing a nocturnal urinary volume greater than the bladder capacity, (3) or mixed     nocturia, a combination of the preceding two categories.      Desmopressin, a synthetic analogue of the antidiuretic hormone (ADH), has been used for many     years to treat diabetes insipidus and primary nocturnal enuresis.More recently, it is also     known to be effective against nocturia with NP by decreasing night-time urine     production.However, it may be associated with an increased risk of developing hyponatremia     due to water retention, especially in elderly patients.In the present study, we investigated     the safety and efficacy of oral desmopressin for the treatment of mixed nocturia in patients     with both NP and a low NBC.   "
232928|NCT00902668|"     RATIONALE: Drugs, such as lovastatin, may protect normal cells from the side effects of     radiation therapy.      PURPOSE: This phase II trial is studying how well lovastatin works in reducing side effects     after radiation therapy in women with breast cancer.   "
232929|NCT00902681|"     This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended     releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.   "
232930|NCT00902694|"     This study will determine whether a behavioral weight loss intervention including dietary     counseling and exercise is effective in helping people with serious mental illnesses lose     weight.   "
232931|NCT00902707|"     The purpose of this research study is to test the ability of Mucinex, an oral,     over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles     from the subject's lungs (called mucociliary clearance). The study will also monitor the     metabolism of the drug by the subject's body.   "
232932|NCT00902720|"     The purpose of this study is to offer an alternative method to women who wish to preserve the     possibility of fertility, as well as to learn more about the ability of human eggs to survive     and function after long term storage in frozen ovaries (ovarian tissue cryopreservation). The     study will seek to preserve ovarian tissue and reproductive potential for patients whose     medical or surgical treatment may harm ovaries or remove ovarian tissue.   "
233557|NCT00914459|"     The study will be investigating pharmacokinetics, safety and efficacy in patients less than     12 years of age with severe hemophilia A that have been previously treated with Factor VIII     products ( including blood products).   "
232935|NCT00902759|"     The purpose of this pilot study is to determine the effects of a walking program on fatigue,     physical functioning and QOL in patients with pancreatic and periampullary cancers who have     had surgery or are undergoing adjuvant therapy with chemotherapy (CT) and/or radiation     therapy (RT). This pilot study will utilize the walking program developed by Mock et al.     (2001), in their investigation of the improvement of fatigue and QOL in breast care patients     following surgery who were receiving CT, RT or biotherapy. No studies published to date have     utilized a progressive walking program in post-operative pancreas and ampullary cancers to     determine if it reduces adverse effects, such as fatigue or improves functionality and QOL     scores.   "
232936|NCT00902772|"     The purpose of this study is to examine the abuse potential of AZD7325.   "
232937|NCT00902785|"     Identify early markers of choroidal neovascularization (CNV) in the fellow eye of a patient     with CNV in the other eye due to age-related macular degeneration with the expectation of     being able to identify patients in need of intervention.   "
232938|NCT00902798|"     This study will investigate and contrast the effects of two psychological treatments for     adults with autism spectrum disorder. Cognitive Enhancement Therapy (CET) is a cognitive     remediation intervention that aims to help adults with problems in thinking, planning, and     socialization. Enriched Supportive Therapy (EST) is an individual supportive therapy that     aims to help adults learn about their condition, manage their emotions and stress, improve     their social skills, and cope with everyday problems.   "
232954|NCT00903006|"     The goals of this clinical research study are to learn the tolerable and effective doses of     the drug MK-0646 that can be given in combination with Sprycel (dasatinib) and Faslodex     (fulvestrant) to patients with hormone receptor-positive metastatic breast cancer. The safety     of these drugs will be studied as well as markers in the tumors that may help researchers     predict the tumors' reaction to the treatment.   "
232955|NCT00903019|"     This study will test the feasibility and effectiveness of therapy given via teleconferencing     to depressed homebound older adults.   "
232939|NCT00902811|"     Antimalarial drug resistance is increasing nearly everywhere in the tropical world,     confounding global attempts to Roll Back Malaria. South East Asia has the most resistant     malaria parasites in the world. This has limited the options for treatment in this region.      Artemisinin-based combination therapy is now the recommended treatment for uncomplicated     falciparum malaria. The success of this policy change in practice will depend on the efficacy     of the components of the combination used, the population coverage achieved, high levels of     adherence to treatment, low cost of the drugs, and preferably the drugs in a combination     treatment should be formulated in a single tablet, to prevent one drug being taken without     the partner drug. Until recently there were only two artemisinin-based fixed combinations     available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former     has international registration. More fixed combinations are needed urgently.   "
232940|NCT00902824|"     This trial will study a prime-boost vaccine approach designed mainly to induce cell-mediated     immune (CTL) responses.   "
232941|NCT00902837|"     The primary objectives are        -  to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment          with OxyPR with regards to analgesic efficacy and locomotor function.        -  to demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone          prolonged release tablets have improvement in symptoms of constipation compared to          subjects taking oxycodone prolonged release tablets alone   "
232942|NCT00902850|"     The objective of this one-day study will be to evaluate the clinical performance of SofLens     Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.   "
232943|NCT00902863|"     This project seeks to measure the effectiveness of a course in self-management strategies     (including yoga, mindfulness, and breathing exercises). The course will be provided by a     certified yoga instructor to patients being followed at the Pain Management Centre, Hamilton     Health Sciences (HHS).   "
232944|NCT00902876|"     The purpose of this multi-center study is to determine the efficacy and safety of Mucograft®     in combination with the coronally advanced flap (CAF) for the treatment of gingival     recessions. It is assumed that the CAF combined with Mucograft® will result in improved     outcome in terms percentage of root coverage and soft tissue thickness in comparison to CAF     alone (control).   "
232945|NCT00902889|"     This is a single centre, controlled phase I study, which evaluates safety and efficacy of     stimulation of lower caudal two contacts (GPI) vs. upper cranial two contacts (GPE) in     Huntington´s disease (HD).   "
232946|NCT00902902|"     The aims of this study were divided into three parts:        1. To evaluate the sensitivity and specificity of GP73 for the diagnosis of hepatitis B          related HCC. Established the standard of GP73 in normal people.        2. To definitude the connections between the GP73 level and various diseases.        3. To find the relations of HCC metastasis and recurrence.      Study design:        1. Collectivity type: Prospective，randomized, controlled, multi-central clinical study.        2. Patients: The subjects were from different hospitals including: Peking Union Medical          College Hospital (PUMCH), The Cancer Hospital of Peking Union Medical College (PUMC),          QiDong Cancer Institute, and Department of Surgery University of Chicago from November          of 2007 till the end of this study.      Study arrangement:      This study was consisted of three parts:        1. Established the standard of normal people and test the sensitivity and specificity of          HCC patients. The samples were acquired from Health Screen Center and Department of          liver surgery of PUMCH, The Cancer Hospital of PUMC and QiDong Cancer Institute.        2. Extend the study bound, including the hepatitis B virus (HBV) and hepatitis C virus          (HCV) carriers. The HBV (+) samples were come from Chinese hospitals and institutions.          The HCV (+) samples were provide by the Department of Surgery University of Chicago.        3. Research the relations of serum GP73 level and the other diseases, such as other          malignant liver tumors, liver metastatic tumors, liver benign tumor, HCC recurrence          following surgery etc.   "
232947|NCT00902915|"     The purpose of this study is to determine efficacy of lenalidomide and dexamethasone in the     treatment of patients with acute Myeloma (light chain)-induced renal failure.   "
232948|NCT00902928|"     The purpose of this study is to evaluate the efficacy and safety of various doses of YM150     (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in     patients that are undergoing elective hip replacement surgery.   "
232949|NCT00902941|"     There is convincing evidence from numerous studies using both psychophysical and     electrophysiological approaches that olfaction is markedly reduced in Parkinson´s disease     (PD). Data on the prevalence of olfactory dysfunction in PD however, range from 45% and 49%     in the pioneering studies of Ansari & Johnson, and Ward, respectively, up to 74% in the work     of Hawkes et al., or as high as 90% in a study published by Doty et al. Quality of life,     safety, and interpersonal relations, as well as food behavior/nutritional intake are severely     altered in a large proportion of patients with olfactory loss. Thus, the same can be assumed     in patients with Parkinson's disease. If it was possible to improve olfactory function this     would appear as a significant effect in patients with Parkinson's disease. Provided the study     would reveal an improvement of olfactory function following therapy with rasagiline, this     would have tremendous worldwide impact on the use of this drug. Considering the frequency of     PD a very large number of patients would benefit from these findings, especially in terms of     quality of life.   "
232950|NCT00902954|"     The purpose of this study is to compare the rate of disease free survival (DFS) and distant     disease free survival (DDFS) at 5 years in postmenopausal women with hormone receptor and     lymph node positive breast cancer randomized between anastrozole/letrozole 5 years and     anastrozole/letrozole 2-3 years switching to exemestane 3-2 years.   "
232951|NCT00902967|"     The study is planned to check the analgesic and anti-inflammatory properties of Atorvastatin     in patients who will be undergoing abdominal surgery under spinal anesthesia. The     investigators intend to monitor the analgesic requirements, the rate of wound healing and the     inflammatory markers in this trial.   "
232952|NCT00902980|"     This is a multicentre, observational, non-interventional, retrospective analysis by chart     review.   "
232953|NCT00902993|"     This study is designed to evaluate the safety, tolerability and PK of AZD1446 in Subjects     when given as multiple dose administration for either 7 Days (Day 1 single dose, Day 2-6     multiple doses) in Part A and optionally at fractionated doses for 1 Day in Part B.   "
232956|NCT00903032|"     We propose to test the effectiveness of a multi-faceted patient-centered adherence     intervention among veterans following ACS hospitalization to improve adherence to     cardioprotective medications (primary aim). Secondary aims will assess whether the     intervention improves achievement of secondary prevention blood pressure (BP) and low density     lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI     hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.      ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to     cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by     helping veterans take their medications routinely as prescribed, the quality of     cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been     associated with improved outcomes, and the efficiency of care by using telephone calls and     tele-monitoring for communication with patients rather than clinic visits. The findings of     the study will address an important gap in knowledge (i.e., how to improve adherence to     medications following ACS discharge) and will be generalizable to other VA Medical Centers     and veterans.   "
232957|NCT00903045|"     Overactive bladder (OAB) is defined as urgency, with or without urge incontinence, usually     with frequency and nocturia in the absence of local pathological or endocrine factors.     Urgency is defined as the complaint of a sudden compelling desire to pass urine that is     difficult to defer and an abnormal sensation that is distinctly different from the normal     physiologic feeling of 'urge to void' that occurs during typical bladder-filling cycles.      Because up to 50% of patients with OAB experience urgency without incontinence, and because     urgency is the most bothersome symptom that drives behavioral adaptations such as frequent     voiding because of the very fear of urgency, this is the cornerstone symptom of OAB that     indicates the diagnosis of OAB.      Even though any effective treatment for OAB must reduce the patient's sense of urgency, its     subjective nature makes it difficult to measure. Therefore, the clinical efficacy of OAB     treatment was traditionally measured in terms of objective surrogate parameters instead of     urgency itself: for example, change in urinary frequency, incontinent episodes, number of     pads and urodynamically proven detrusor overactivity, which could be measured easily and     quantifiably.      Recently, several methods that measure urgency have been developed and used in clinical     practice. However, the analysis questioned the clinical significance of the results; a     possible reason for this being the lack of data based on urinary urgency and the use of     sensitive patient-driven criteria.      Propiverine hydrochloride (1-methyl-4-piperidyl diphenylpropoxyacetate hydrochloride) is a     drug with combined antimuscarinic and calcium antagonistic actions. Previous trials on the     clinical efficacy and safety of propiverine for treating patients with OAB have reported     improvements in urinary frequency and incontinence, but not in urgency.      The aim of this study was to explore the efficacy of a daily regimen of propiverine at 20 mg     (immediate release formulation) in improving urgency from baseline to 12 weeks of treatment     in patients with OAB.   "
232958|NCT00903071|"     In this project the investigators implement and test the ability of a Personalized Physician     Learning (PPL) intervention to improve hypertension (HT) care with the following specific     aims:      Specific Aim 1: Implement two versions of a Personalized Physician Learning (PPL)     intervention and assess the ability of these interventions to improve hypertension control in     primary care practice.        -  Hypothesis 1: Patients of physicians who receive the REAL+PPL Intervention (Group 1)          will subsequently have better HT control compared to patients of control group          physicians (Group 3).        -  Hypothesis 2: Patients of physicians who receive the SIM+PPL Intervention (Group 2) will          subsequently have better HT control compared to patients of control group physicians          (Group 3).        -  Hypothesis 3: Patients of physicians who receive the REAL+PPL (Group 1) will          subsequently have better HT control compared to patients of physicians who receive the          SIM+PPL (Group 2).      Specific Aim 2: Assess the cost-effectiveness of the SIM+PPL and REAL+PPL interventions,     relative to no intervention.   "
232959|NCT00903084|"     This study will determine whether a hair test can reveal how much of the anti-HIV medication     tenofovir a person without HIV has been exposed to.   "
232960|NCT00903110|"     The Eu-IGFD is a descriptive, multicenter, observational, prospective, open-ended, non     interventional, post-authorisation surveillance registry. The purpose of this study is to     collect long-term safety information on the use of recombinant DNA-derived human Insulin-like     Growth Factor-1 (rhIGF-I) Increlex® replacement therapy for the treatment of children with     growth failure.   "
232961|NCT00903136|"     RATIONALE: A tethered capsule endoscope may be as effective as standard sedated endoscopy of     the esophagus, stomach, and duodenum in screening for Barrett esophagus.      PURPOSE: This phase I/II trial is studying how well a tethered capsule endoscope works in     screening participants for Barrett esophagus.   "
233790|NCT00915564|"     The purpose of this study is to evaluate the effect of steady-state (constant concentration     of medication in the blood) TMC435 (150 mg, once a day) on the steady state pharmacokinetics     (what the body does to the medication) of R- and S-methadone.   "
232962|NCT00903149|"     The purpose of this study is to investigate if a cost and time effective intervention in a     previous RCT for preterm infants and their parents can reduce the parents experience of     concern and stress, and improve the childrens development in various aspects at three years     of corrected age.      Hypothesis 1: The preterm born children of parents who were enrolled in the earlier RCT have     a higher developmental level then preterm children of parents who received the usual     treatment.      Hypothesis 2: Parents who who were enrolled in the earlier RCT will have a lower level of     stress and concern then parents who received treatment as usual.   "
232963|NCT00903162|"     The purpose of this study is to determine the safety and tolerability of the combination of     two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least     4.5 years. Letrozole, an aromatase inhibitor (which blocks an enzyme that produces estrogen),     is a drug that is FDA approved. It has been shown to reduce the risk of breast cancer     recurrence in postmenopausal women with breast cancer who have been previously treated with     tamoxifen. Letrozole works by stopping the production of estrogen in parts of the body other     than the ovaries. Leuprolide is a drug that stops a women's ovarian cycles. This process is     known as ovarian function suppression. Stopping a women's menstrual cycle may be effective     against breast cancer for some patients when given as initial therapy. The combination of     letrozole and leuprolide is considered a standard treatment for women with metastatic breast     cancer, and is also sometimes used for treatment of premenopausal early stage breast cancer,     but it has not been accepted as a standard of care treatment.   "
232964|NCT00903175|"     This study assessed the efficacy and safety of first-line RAD001 followed by second-line     sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001     for the treatment of patients with MRCC.   "
232965|NCT00903188|"     This study intends to determine whether steroid withdrawal or calcineurin inhibitor     withdrawal is superior for graft function and graft survival. Secondary endpoints for this     study are: incidence of tumors and cardiovascular events.      The primary objective: To assess if superior graft function (glomerular filtration rate (GFR)     difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de     novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to     Myfortic-cyclosporine.   "
232968|NCT00903227|"     Up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway     inflammation with topical steroids improves the twitchiness of the airways     (hyperresponsiveness) and overall asthma control. The use of inhaled corticosteroids reduces     symptoms, severity of asthma attacks, improves quality of life, and reduces asthma related     deaths. Similarly, treatment of rhinitis with nasal steroids reduces symptoms and improves     quality of life. While there is evidence that combined treatment of the nose and the lungs     with topical steroids improves symptoms and underlying inflammation, it is unclear whether     such control can be achieved using a smaller dose of inhaled steroid in combination with     nasal steroid. It is therefore the intention of this study to evaluate if combination steroid     therapy (nose and lungs) has a steroid sparing effect in patients with asthma and rhinitis     using sensitive markers of airway inflammation.   "
232969|NCT00903240|"     The purpose of this study is to detect recurrent bladder cancer using a combination of     protein and DNA biomarkers in urine   "
232970|NCT00903253|"     The objective of this study is to evaluate the single-dose plasma pharmacokinetics of LNK-754     as well as safety and tolerability in normal healthy male and female elderly volunteers   "
232971|NCT00903266|"     We are doing this clinical trial in order to evaluate two different treatments for non-fluent     aphasia: Melodic Intonation Therapy (MIT) and Speech Repetition Therapy (SRT). MIT uses a     simple form of singing, while SRT uses intensive repetition of a set of words and phrases. We     want to see which intensive form of treatment is more effective in leading to an improvement     in speech output compared to a no-therapy control period, and whether either treatment can     cause changes in brain activity during speaking and changes in brain structure. We will use a     technique known as functional Magnetic Resonance Imaging (fMRI) to measure blood flow changes     in the brain and structural MRI that assess brain anatomy and connections between brain     regions. We will use fMRI to assess brain activity while a patient speaks, sings, and hums.     We will assess changes in brain activity and in brain structure by comparing scans done prior     to treatment to scans obtained after treatment and we will also examine changes between     treatment groups. We will correlate changes in brain activity and brain structure with     changes in language test scores.   "
232972|NCT00903279|"     The investigators anticipate that utilization of retapamulin preoperatively will eliminate     MRSA colonization among patients who are colonized in their nares.   "
232973|NCT00903292|"     Currently the investigators have two different classes of second-line treatment options in     recurrent non-small Cell Lung Cancer (NSCLC). In chemotherapy, docetaxel and pemetrexed     produced similar treatment efficacy outcomes, while pemetrexed had a better tolerability. In     recent analysis of pemetrexed clinical studies, a strong treatment-by-histology interaction     in overall survival and progression free survival that indicated better efficacy for     non-squamous patients treated with pemetrexed. These data supports that pemetrexed could be a     preferable chemotherapy drug especially in adenocarcinoma NSCLC patients.   "
232974|NCT00903305|"     RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective     than standard care in treating patients with breast cancer.      PURPOSE: This clinical trial is studying nurse-provided care to see how well it works     compared with standard care in treating patients with stage I, stage II, or stage III breast     cancer.   "
232975|NCT00903318|"     Objective 1: To assess environmental exposure to chemicals/toxins, including phthalates,     among rural and urban Mexican American men and women (n=300), aged 18 to 40, in urban     Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico     border region via survey.      Objective 2: To determine generational sex ratio trends in urban Baytown, TX and along the     rural Rio Grande Valley (Hidalgo County) utilizing vital statistics data from the Texas     Department of Health and the Center for Health Statistics.      Objective 3: To measure urinary phthalate levels and self-reported phthalate exposure in     Mexican American men and women from urban Baytown, Texas and rural communities along the     lower Rio Grande Valley (Hidalgo County) on theTexas-Mexico border. To conduct an optional     procedure, chromosomal sex determination, among a subgroup of 50 persons (13 men + 12 women     in each community) from participants who complete the survey in Objective 1.   "
232976|NCT00903331|"     The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan)     10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study     objective is to demonstrate that macitentan positively affects the forced vital capacity     (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF).      The secondary objectives are to evaluate the effect of macitentan on the time to disease     worsening or death in patients with IPF, and to evaluate the benefit/risk profile of     macitentan in the treatment of patients with IPF.   "
232977|NCT00903344|"     Studies have shown that lactation is associated with a loss of bone density from four to     seven percent at the spine and hip among women who lactate for six months. Decline in bone     density with lactation occurs rapidly. Although bone density increases after weaning, there     is controversy on whether or not it is completely restored. Epidemiological studies find no     significant negative impact of lactation on bone mass or fractures, and in fact there is     evidence that lactation has a positive effect on bone mass. We think that interventions that     attenuate this physiologic loss of bone that is associated with lactation and accelerate     restoration of bone mass after weaning may result in improved long term bone mass and     diminished fracture risk.   "
232978|NCT00903357|"     The purpose of this study is to assess the clinical effectiveness of Montelukast in children     (2~6 years old) with atopic dermatitis and identify the pathophysiologic background of     Montelukast on the role of modulating the atopic dermatitis measured by urinary Leukotriene 4     (LTE4) and Eosinophil protein X(EDN).   "
233002|NCT00903695|"     A vitamin nutriceutical, Memory XL, has been shown to provide maintenance of cognitive status     in mild, moderate, and severe Alzheimer's disease patients (2 publications by T. Shea).     Because this nutriceutical is now patented by the Univ. of Mass., other trials at that     institution may be considered a conflict of interest. Therefore, a study of its effects on     Mild Cognitive Impairment (MCI) patients will be conducted by PI who is not affiliated with     Univ. of Mass. or with Dr. Shea. The study hypothesis is: Memory XL will maintain or improve     the cognitive and behavioral status of patients diagnosed with MCI during the year of     participation in the study; normally, 10-25% of MCI patients convert to mild Alzheimer's     dementia each year.   "
232979|NCT00903370|"     The purpose of the research is to determine whether treating atrial fibrillation with     surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery     by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a     technique used by surgeons to deaden atrial heart tissue and block electrical signals that     may be causing your heart to beat irregularly. There are no new procedures being tested in     this study; both mitral valve surgery and surgical ablation are used regularly in patients     who have mitral valve problems and atrial fibrillation, although no surgical ablation devices     have been approved by the Food and Drug Administration for the treatment of atrial     fibrillation. What is not known with certainty, is whether patients with atrial fibrillation     who are having planned mitral valve surgery would do better if they also had surgical     ablation rather than medication alone to treat their atrial fibrillation.   "
232980|NCT00903383|"     The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305     versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate     therapy.   "
232981|NCT00903396|"     RATIONALE: Palonosetron hydrochloride may prevent nausea and vomiting caused by radiation     therapy. It is not yet known whether palonosetron hydrochloride is more effective than a     placebo in preventing nausea and vomiting.      PURPOSE: This randomized phase II trial is studying the side effects of palonosetron     hydrochloride and to see how well it works in preventing nausea and vomiting caused by     radiation therapy in patients with primary abdominal cancer.   "
232982|NCT00903409|"     In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4     g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with     simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This     extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza®     (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin     plus placebo to simvastatin plus Lovaza® for lowering non-High Density     Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at     12 and 24 months.   "
232983|NCT00903422|"     This study will evaluate the safety and tolerability of eltrombopag in the treatment of low     platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary     acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or     ineligible to receive azacitidine, decitabine, intensive chemotherapy or     autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which     patients will receive study medication daily for 6 months, during which time the dose of     study medication may be adjusted based upon individual platelet counts and bone marrow blast     counts. All subjects will receive best standard of care (platelet transfusions, mild     chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition     to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag     treatment if a clinically and statistically significant improvement in bone marrow blast     counts is seen in subjects treated with eltrombopag.   "
232984|NCT00903435|"     The purpose of this study is to determine whether more than one subpopulation exists of     patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to     determine if subjects with IC have normal counterirritation-related modulatory systems.   "
232985|NCT00903448|"     The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid     suppression.   "
232986|NCT00903461|"     The Epidermal Growth Factor Receptor (EGFR) is highly expressed in SCCHN and its     overexpression is associated with poor patient outcome. EGFR is a promising target of     anticancer therapy. We have developed EGFR antisense DNA as a safe and potentially     efficacious treatment for SCCHN as shown in a previous phase I study conducted at the     University of Pittsburgh. Cetuximab (Erbitux or C225) is a chimerized EGFR monoclonal     antibody that has produced positive results in a phase III trial in SCCHN when added to     radiation therapy and was approved by the FDA for the treatment of locally advanced SCCHN.     Radiation plus cetuximab is considered a standard treatment, especially for patients who are     not good candidates for chemotherapy. In the current study, we plan to evaluate the addition     of intratumoral EGFR antisense DNA (EGFR AS) to standard radiation with concurrent cetuximab     in patients.   "
232988|NCT00903500|"     The intervention consists of an individual counseling session, telephone counseling (7     calls), given by a psychologist, and a pedometer. The intervention is based on cognitive     behavioral therapy, the Diabetes Prevention Program, the first Step Program and Motivational     Interviewing. The taxonomy of behavior change techniques is also taken into account. The     duration of the intervention is six months. The individual session takes place one week after     the baseline measurements, together with the participants' follow-up appointment with their     endocrinologist. The individual session takes place at the endocrinology department and is     expected to last approximately 30 minutes. In addition to the session, the participants of     the intervention group receive a pedometer and a pedometer diary for six months. Participants     of the intervention group also receive telephone counseling from the psychologist during 24     weeks. They receive a call every two weeks for four weeks and then every four weeks for the     next 20 weeks, good for a total of seven counseling calls. The calls are expected to last     approximately 20 minutes. The Control Group has no intervention at all and receive their     usual care.   "
233003|NCT00903708|"     Primary Objective:        -  To determine a recommended Phase 2 dose of LY2275796 that may be safely administered to          patients with advanced cancer, with prospects for therapeutic biologic effects. This          will require simultaneous:        -  monitoring of toxicities & determination of maximal tolerated dose (MTD)        -  detecting eIF-4E target inhibition in tumor        -  pharmacokinetic measurements      Secondary Objectives:        -  To estimate pharmacokinetic parameters of LY2275796 and explore          pharmacokinetic/pharmacodynamic relationships        -  To document any antitumor activity observed with LY2275796   "
232989|NCT00903526|"     During the past two decades, the frequency of invasive fungal infections has increased     dramatically in hospitalised patients throughout the world, and Candida has now emerged as     one of the leading causes of bloodstream infections (BSIs). Risk-factors for invasive     candidiasis include improvements in intensive care strategies (i.e., central venous     catheters, mechanical ventilation, hyper-alimentation), prolonged stays in intensive care     units (ICUs), the development of more aggressive surgical techniques, and the prolongation of     survival of critically-ill patients. Two other important factors, observed mainly in cancer     patients, are colonization of mucous membranes by yeasts, and neutropenia, resulting from     increased use of antibiotics and anti-neoplastic agents, respectively. The crude mortality     rate of candidaemia is high (38-75%), and the attributable mortality has been estimated at     25-38%. During the past 15 years, the prevalence of infections caused by non-albicans Candida     spp. has increased exponentially, so that these organisms now account for > 50% of episodes     of fungaemia in various surveys. The increase in invasive fungal infections, the associated     high mortality rate, and the emergence of antifungal resistance, have all driven the search     for more potent antifungal drugs. The aims of the present study are to investigate the     prevalence and the epidemiology of candidaemia and to determine the antifungal susceptibility     patterns of Candida spp. isolates from a tertiary-care hospital in Italy.   "
232990|NCT00903539|"     To prospectively monitor the safety and performance of the catheter securement device in     subjects whose catheter is secured with the Interrad Medical SecureAcath device.   "
232991|NCT00903552|"     This is a phase 2A randomized, double blind, placebo controlled trial to evaluate the safety     and immunogenicity of a trivalent seasonal influenza virus-like particle (VLP) vaccine     (recombinant) in healthy adults.   "
232992|NCT00903565|"     The aim of this study is to enroll 785 eligible stage II colon cancer patients in order to     validate the performance of ColoPrint in estimating 3-year relapse rate.      Secondary objectives include comparing the objective risk assessment results from the     prognostic profile (ColoPrint) to both the risk assessment based on the ASCO criteria, as     well as the Investigator's independent assessment. As this is the first prospective study of     ColoPrint, this study will also address the logistics and quality assurance of using     ColoPrint in clinical practice.      Patient treatment is at the discretion of the physician, adhering to National Comprehensive     Cancer Network (NCCN)-approved regimens or a recognized alternative.      The enrollment period will be 6 years. It is expected that 1800 to 2400 patients will be     enrolled in order to obtain 785 analysable stage II samples from eligible patients.     Approximately 25-35 clinical sites will be involved worldwide.      The statistical analysis will be performed by Agendia and an independent research institute     or hospital.      Study Design Extension Study:      This will be a prospective study to measure the impact of ColoPrint on adjuvant treatment in     stage 2 colorectal cancer patients. After surgery the tumor sample will be shipped in RNA     Retain to Agendia. The online Clinical Report Form (CRF) 0 will be completed to document if     the patient fulfils the inclusion criteria. Baseline clinical data and the patient and     physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict     without knowing the ColoPrint result will be entered in CRF 1. After completion of CRF1 the     ColoPrint result is released. CRF2 will be completed after the final treatment decision has     been made.      This CRF will capture the patient and physician chemotherapy intention, patient's perceived     recurrence risk and decisional conflict, impact of ColoPrint and the actual treatment the     patient will receive. CRF3 will be completed 12 months after enrolment and will capture the     patient status, patient's perceived recurrence risk and decisional conflict. CRF4 and 5 will     be completed 3 and 5 years after surgery and will capture the patient status. A sample size     of 210 stage 2 colon cancer patients is required to detect a 10% overall treatment change (5%     significance and 90% power).      Reporting of the Results:      Blinded Study; The ColoPrint results will not be reported to the physician and/or patient at     the time of enrolment. All samples will be stored in a freezer until 550-575 eligible stage     II patients have been enrolled. Samples will then be analyzed in one batch in a blinded     fashion from the clinical results.      Extension Study; The ColoPrint results will be reported to the physician and patient after     CRF1 has been completed.   "
232993|NCT00903578|"     The present study will examine whether serum FGF-23 and serum phosphate at baseline of kidney     transplant recipients can predict progression of allograft dysfunction at 3 years and     all-cause mortality at 5 years.   "
232994|NCT00903591|"     This study is being done to find out what factors may be related to the risk of getting a     second breast cancer among women who already have breast cancer in one breast. It will look     at how genes, treatment for breast cancer; including radiation therapy, and the effects of     different lifestyle activities, may affect the risk of breast cancer. It will use different     processes to find genes that might increase the risk of breast cancer. The results of this     study may help to develop better ways to detect, treat and prevent breast cancer. This study     will compare women who have breast cancer in both breasts to women who have breast cancer in     only one breast.   "
232995|NCT00903604|"     The purpose of the present research study is to investigate the pharmacokinetics, as well as     safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in     patients undergoing cardiac surgery. AP214, the investigational drug, is being developed to     potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.   "
233038|NCT00904163|"     Recessive dystrophic epidermolysis bullosa (RDEB) is a severe inherited blistering disease     caused by the absence of type VII collagen. Patients with RDEB develop large, severely     painful blisters and open wounds from minor trauma to their skin. We are screening RDEB     subjects to determine additional characteristics of patients who survive to adulthood.   "
233791|NCT00915577|"     Determine patient satisfaction with the single-use autoinjector for the delivery of     pre-filled Avonex syringe.   "
232996|NCT00903617|"     This is a two part study (Part A and Part B) that will first aim to establish the PK/PD     relationship between exposure and lipid effects (Part A: 75 subjects), and will then confirm     the effect using the most relevant dose(s) (Part B: ~90 subjects). Doses of 5mg, 50mg and     150mg of GSK256073 will be administered in Part A, and the dose(s) for Part B will be based     on the PK/PD data from Part A. Data from Part A and Part B will be combined to decrease     overall subject numbers needed in part B. Part B of the study will include a niaspan arm for     relative comparison of the effects of GSK256073 and niacin on lipids and flushing   "
232997|NCT00903630|"     RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor.     Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving lenalidomide together with doxorubicin hydrochloride liposome may kill more     tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide     when given together with doxorubicin hydrochloride liposome in treating patients with     recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.   "
232998|NCT00903643|"     The purpose of this study is to determine if clinically relevant subsets exist in patients     meeting the diagnosis of Painful Bladder Syndrome (PBS). Subsets suggest differential     responses to treatments and if verified, this will be important for the stratification of     patients in clinical studies related to PBS.   "
232999|NCT00903656|"     The aim of this study is to evaluate the potential of a Lapatinib plus Caelyx combination     therapy as an effective and safe therapeutic regimen with a favourable cardiotoxicity     profile, in the treatment of metastatic breast cancer following failure of prior trastuzumab.   "
233000|NCT00903669|"     The current study sought to determine the reliability of the rehabilitation protocol using     the labial commissure angle (LCA) as an indicator of both muscle tonus and therapeutic     success. The investigators hypothesized that this measurement would provide objective data     regarding the efficacy of rehabilitation for these challenging patients.   "
233004|NCT00903721|"     The investigation will be conducted to define safety and efficacy under the conditions of     post-marketing use of this drug in subjects with allergic rhinitis.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
233005|NCT00903734|"     The goal of this screening portion of this clinical research study is to learn if you are     eligible to take part in a clinical research study using Tarceva (erlotinib hydrochloride)     and either Erbitux (cetuximab), Velcade (bortezomib), or Sprycel (dasatinib).      If the results of the screening portion of this clinical research study show that you are     eligible to take part in one of the studies described above, the study drug that you will be     assigned to take will depend on the results of biomarker analysis performed as a part of the     screening tests described below. Biomarkers are chemical markers in the blood/tissue that     may be related to how your body might react to the study drug.   "
233006|NCT00903747|"     This is a 2-arm, parallel-group active- and placebo-controlled, double-blind randomised     study, stratified by gender and with a hybrid crossover group design, to compare treatment     with prucalopride 2 mg/day (intended therapeutic dose) and prucalopride 10 mg/day     (supratherapeutic dose) with placebo. A single oral dose of 400 mg moxifloxacin is included     as a positive control in terms of the effect on cardiac repolarisation.      Study hypothesis:      Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in     healthy male and female volunteers will not increase QTc interval compared to placebo.   "
233007|NCT00903760|"     The goal of this clinical research study is to learn if sequential administration of     decitabine and clofarabine can help to control MDS better than decitabine alone. The safety     of this drug combination will also be studied.   "
233008|NCT00903773|"     The purpose of this study is to investigate the effect of severe renal impairment or failure     on the single-dose pharmacokinetics of telaprevir (TVR). Pharmacokinetics means how the drug     is absorbed into the bloodstream, distributed in the body and eliminated from the body. In     addition, the effect of severe renal impairment on the total and unbound plasma     concentrations of the sum of TVR and its R-diastereomer VRT-127394 will be assessed.     (Diastereomers are substances whose chemical structures are mirror images of each other).     Finally, the short-term safety and tolerability of TVR in participants with severe kidney     disease will be determined. The results of this study will guide dose recommendations for TVR     in subjects with kidney disease.   "
233009|NCT00903786|"     The purpose of this trial is to investigate the safety and tolerability of perampanel in     long- term treatment in the patients with refractory partial epilepsy (uncontrolled with     other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.   "
233010|NCT00903799|"     The aim of this clinical trial is to assess the symptomatic efficacy and the impact on the     utilization of healthcare resources of a treatment by gastric electrical stimulation (ENTERRA     ®) in patients with refractory nausea and/or vomiting leading to a nutritional impairment.     Eligible patients will be those with refractory symptoms either idiopathic, postsurgical or     due to diabetes mellitus. The duration of the study will be 28 months for each patient.      After a run-in period of 4 months during which a prospective assessment of healthcare     resources utilization and of the severity of the symptoms will be obtained, patients will be     implanted. The follow-up period after implantation of the device will last 24 months in every     patients and will be divided in two parts: a) After the first postoperative month during     which the device will remained on the OFF position, the first phase of the study will be a     randomized double-blind cross-over study with 2 periods of 4 months during which the device     will be activated or not. After the 9th month of follow up, the trial will be an open trial     and the device will be activated in all patients.      During the whole trial, patients will record all types of healthcare resources utilizations     (hospitalizations, drug treatments, endoscopic procedures…) while the symptomatic efficacy of     the treatment will be assessed by standard questionnaires at the following visits scheduled     at 1, 5, 9, 12, 18, 24 months. The glycemic control will be determined at each visit in     diabetic patients. A delayed gastric emptying will not be a selection criteria but we have     planned to analyze the clinical results of the treatment in taking into account a delayed or     normal gastric emptying during the pre-implantation period. Moreover, gastric emptying     studies have been scheduled at 5, 9, 12 and 24 months to test the impact of gastric     electrical stimulation on gastric emptying.   "
233011|NCT00903812|"     This is multi-center, international observational study of subjects receiving CHOP-14 or     CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites     will contribute information on subjects treated at their institution.   "
233039|NCT00904176|"     The purpose of this study is determine that Dapagliflozin has no effect on the     pharmacokinetics (PK) or pharmacodynamics (PD) of warfarin when dapagliflozin is     coadministered with warfarin. Also, that Dapagliflozin has no effect on the PK of digoxin     when dapagliflozin is coadministered with digoxin.   "
233012|NCT00903825|"     The aim of this study is to evaluate the optimization of local anesthetic effect with duplex     ultrasound-guided injection of lidocaine before femoral artery puncture during diagnostic or     therapeutic interventional procedures.      In total, 200 patients scheduled for various diagnostic or therapeutic interventional     radiology procedures requiring femoral artery puncture, will be randomized in two groups     after informed consent. Patients will be randomized to undergo groin local anesthesia with     the proposed method of duplex ultrasound guided injection of lidocaine versus standard     injection of lidocaine with manual palpation (control group).      The protocol includes the registration of patients' demographics (age, gender, risk factors     for peripheral arterial disease), arterial morphological characteristics (calcifications and     presence of atheromatous disease), as well as technical details of the procedure (total     puncture duration, sheath size, antegrade/retrograde puncture, etc.)      Primary study endpoint will be peri-procedural pain that will be assessed with the use of a     visual analog scale (VAS) completed by the patient at the end of the procedure. Secondary     study endpoints will evaluate procedural safety and complications during the immediate     post-procedural period (up to 7 days).   "
233013|NCT00903838|"     This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study     of pardoprunox as adjunctive treatment to levodopa.   "
233014|NCT00903851|"     Patients with Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy     with dynamic allodynia of the lower extremities, patients with Type I or II diabetes and pain     distal symmetric sensorimotor polyneuropathy with no dynamic allodynia of the lower     extremities, or patients with idiopathic distal predominantly sensory neuropathy participated     in a Phase IV clinical trial to assess the efficacy of lidocaine patches in treating painful     diabetic neuropathy or idiopathic distal sensory neuropathy.   "
233015|NCT00903864|"     The purpose of this study is to monitor the blood pressure level of the patient using a cuff     ranged 22 cm-30 cm.   "
233016|NCT00903877|"     Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia.     Determine the feasibility and promise of an appropriately powered future prospective     randomized controlled study of using T3 (the active form of thyroid hormone) for the     treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and     promise of conducting a prospective controlled study in the future.   "
233018|NCT00903903|"     The purpose of this study is to compare the data obtained by computer-aided quantification of     the synovial perfusion in patients with arthritis using two-dimensional and three-dimensional     power Doppler ultrasonography and the clinical data used to represent the degree of joint     inflammation. Intra- and inter-observer reliability of this method will also be determined.   "
233019|NCT00903916|"     The purpose of this study is to evaluate changes in appetite-regulating hormones, body     composition (weight, body fat%), and hunger ratings in persons early in treatment with one of     four atypical antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole).   "
233020|NCT00903929|"     Patients who undergo total body irradiation (TBI) for stem cell transplantation have     prolonged periods of low counts of specific blood cells called platelets. These low platelets     counts can cause bleeding and infection. Thus far, no drug is available for use to speed the     recovery of platelets, and therefore transfusions are often necessary.      The purpose of this study is to test the safety of a drug called eltrombopag in patients who     have received TBI. The investigators want to find out what effects, good or bad, it has on     people with low platelet counts due to treatment with TBI. The investigators will also be     testing how well eltrombopag may work at different doses and determine if this drug speeds up     the recovery of the platelets.   "
233021|NCT00903942|"     For patients with stage III Lung Cancer, We propose one cycle chemotherapy using Abraxane and     Carboplatin, followed by pulsed low-dose sensitizing Abraxane chemotherapy and daily     Radiation. This will be followed by more hi-dose chemotherapy. We anticipate this regimen to     target early distant microscopic spread by using one cycle of chemotherapy prior to     radiation, and to achieve control of the disease in the lung by combining pulsed low-dose     sensitizing Abraxane, with radiation.   "
233022|NCT00903955|"     The purpose of this research is to understand the properties of mucus in persons with COPD,     specifically Chronic Bronchitis. We hypothesize that those with Chronic Bronchitis have     dehydrated mucus, and thus have a harder time coughing it out of their lungs. This leads to a     greater vulnerability for lung infection, inflammation and airflow obstruction. Ultimately,     our goal is to understand how mucus dehydration contributes to the progression of     COPD/Chronic Bronchitis so that better therapies and interventions can be developed for     future generations.   "
233023|NCT00903968|"     The purpose of this research study is to determine the safety of plerixafor and bortezomib,     and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma     cells from attaching to bone marrow and has been used in other phase I studies for     mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the     combination of plerixafor and bortezomib is very effective in killing myeloma cells in the     laboratory more than the effect of each drug alone.   "
233024|NCT00903981|"     The purpose of this study is to confirm the efficacy and the safety of Avanafil 100mg, 200mg     or placebo administered orally for 12 weeks in patients with erectile dysfunction. The     efficacy is evaluated by IIEF, SEP Q2 and Q3 and GEAQ and the safety is evaluated by     laboratory tests, vital signs, physical examination and adverse events.   "
233025|NCT00903994|"     Open-label study to be conducted at 2 US investigational sites in subjects who have acute     tendonitis or bursitis of the shoulder, elbow, or knee. Eligible subjects receive treatment     with the KTP, applied once daily at the same application site for 3 consecutive days.   "
233040|NCT00904189|"     This study is to test the effectiveness a new method (called EPR dosimetry) that could be     used to measure radiation doses to fingernails that occur as a result of unplanned exposure     to radiation, such as might occur from the actions of terrorists, or from accidents.   "
233041|NCT00904202|"     Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain     syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or     other peripheral neuropathy participated in a Phase IV clinical trial to assess the     comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in     treating a diverse group of peripheral neuropathic pain patients.   "
233026|NCT00904007|"     Online interactive spaced education (ISE) is a novel educational methodology based on the     spacing effect, the psychological finding that repeated presentations of educational     material over spaced intervals increase learning efficiency and improve knowledge retention.     ISE is delivered using periodic emails that contain clinical case scenarios and     multiple-choice question. The investigators recently completed a randomized trial involving     95 VISN 1 primary care providers (PCPs) which demonstrated that an ISE intervention can     significantly improve clinician's practice patterns. Those clinicians randomized to the ISE     intervention on prostate cancer screening demonstrated a 26% relative reduction in     inappropriate screening. The investigators propose to conduct a randomized controlled trial     involving PCPs in VISN 1 to determine whether ISE can (1) increase knowledge of the     appropriate treatment of hypertensive patients, (2) reduce clinical inertia in hypertension     management, and (3) improve the blood pressure control in hypertensive patients.      Anticipated Impacts on Veterans' Healthcare: This study aims to demonstrate that online     interactive spaced education (ISE) can improve providers' care of patients with hypertension.     ISE is the type of intervention that can be deployed across the VHA with content tailored to     meet specific needs and can be implemented as a tool to improve performance measures and     clinical outcomes   "
233027|NCT00904020|"     Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low     back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin     participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm®     administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients     who had a partial response to a regimen containing gabapentin.   "
233028|NCT00904033|"     Both the calcitriol and exercise interventions are aimed at reducing fracture risk by     maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and     increasing muscle mass. Both calcitriol and exercise are efficacious in maintaining proper     bone health and muscle mass among the general population, but little research has been done     on breast cancer patients and survivors. The combination of calcitriol and exercise, which     function through different but similar mechanisms, could produce interactive effects in     reducing fracture risk among breast cancer survivors.      Hypothesis: A combination of calcitriol along with a structured home-based walking and     progressive resistance exercise program will be efficacious in preventing bone resorption and     in increasing bone formation among survivors of invasive breast cancer.      Primary Objective      To collect data on the efficacy and feasibility of a supplementation of calcitriol     with/without an accompanying structured home-based walking/progressive resistance exercise     program for improving bone health among breast cancer survivors.      Secondary Objectives      To collect data on the efficacy and feasibility of a supplementation of calcitriol     with/without an accompanying structured home-based walking/progressive resistance exercise     program for increasing strength among breast cancer survivors.      To collect data on the efficacy and feasibility of a supplementation of calcitriol     with/without an accompanying structured home-based walking/progressive resistance exercise     program for improving skeletal muscle mass among breast cancer survivors.   "
233029|NCT00904046|"     This study has two aims:      Aim 1: To determine the presence of accumulation of fat within cells and the functional     consequences of this in the kidney by correlating kidney fat content with urine test results.      Aim 2: The investigators will evaluate the effect of thiazolidinedione (pioglitazone) on     excess fatty acid accumulation in kidney tissue and its correlation with uric acid stone     formation in subjects with uric acid stones.   "
233030|NCT00904059|"     The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and     BMS-650032 when co-administered and when administered alone   "
233031|NCT00904072|"     The purpose of this study is to understand the impact of CDSS by knowing the prescribers     actions to the CDSS, also the influence of prescribing error announced by pharmacists.   "
233032|NCT00904085|"     The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with     placebo in patients with mild to moderate pain following outpatient knee arthroscopy.   "
233033|NCT00904098|"     Females 18 years of age or older with at least one year history of menstrual migraine (MM)     headaches participated in a Phase 4 clinical trial to evaluate the efficacy of frovatriptan     when used at the early stage (International Headache Society [IHS] Grade 1) of MM compared     with patients' current treatment.   "
233034|NCT00904111|"     Patients with Chronic Axial Low Back Pain participated in a Phase II clinical trial to assess     the efficacy of lidocaine 5% patch compared with placebo.   "
233035|NCT00904124|"     It has been suggested that dietary fibers can affect food intake and satiation. Satiation, or     meal termination, can be induced by sensory properties and energy density of fiber-rich food     products, but also by the chemical/physical/rheological behavior of the fibers in the stomach     and/or intestine. It is not clear which properties are the key regulators of satiation by     fiber sources. There are many types of dietary fiber, which have diverse sensory and chemical     properties, thus these might have different effects on satiation.   "
233036|NCT00904137|"     Type I supracondylar fractures are elbow fractures that occur in children aged 3-10 years.     Many different treatment options exist to treat this type of fracture. The purpose of this     study is to compare three different treatment modalities with regards to pain experienced     during treatment, the amount of pain medication needed during treatment, and any short-term     complications. We hypothesize that above elbow casting and long-arm splinting will result in     less pain and have fewer complications than taping the elbow in flexion.   "
233037|NCT00904150|"     The investigators hypothesize that genes that play a role in menstrual migraine can be     identified using a well characterised migraine population and a comprehensive genome-wide     association scan approach.      The aim of the study is to identify genes, genetic regions, and the effect of hormones on     expression profiles in women with menstrual migraine compared to a control population with no     personal or first-degree family history of migraine.      In this case control study, saliva samples will be taken from 300 cases and 300 controls for     DNA analysis. Blood samples from 30 cases and 30 controls will be taken during the follicular     phase as well as the luteal phase of the menstrual cycle for ribonucleic acid (RNA) analysis.   "
233042|NCT00904215|"     An observational study to investigate the efficacy, safety, tolerability and the effect on     quality of life of Telmisartan (Micardis) and Telmisartan with HCTZ (Micardis Plus) in     patients with hypertension   "
233043|NCT00904228|"     The purpose of this research project is to ascertain the effectiveness of plastic head     covering in prevention of hypothermia. Hypothermia is defined by body temperature <36.5º     Celsius by the World Health Organization. The surface area of the head is about 20% of total     body surface of a newborn infant and is a major source of heat loss. The objective is to     compare rectal temperature upon admission to the neonatal intensive care between preterm     neonates who had stockinet head covering and those who had plastic-lined stockinet head     covering placed in the delivery room. The investigators aim to demonstrate that plastic-lined     head covering is more effective than stockinet head covering alone in maintaining body     temperature.   "
233044|NCT00904241|"     This research trial studies biomarkers in tumor tissue samples from patients with newly     diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from     patients with cancer in the laboratory may help doctors identify and learn more about     biomarkers related to cancer.   "
233045|NCT00904254|"     The primary objective of this study is to proof the concept of EP 1645 as a diagnostic tool     for carotid artery atherosclerosis and plaque instability and to assess the safety and     tolerability of this diagnostic agent, a monoclonal antibody fragment (Fab') conjugated with     the diagnostic radionuclide 99mTc. Safety and tolerability will be determined by adverse     events (AEs) observed and reported upon administration of the product and the absorbed dose     of radiation.   "
233046|NCT00904280|"     The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone     ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe     pain.   "
233050|NCT00904332|"     Objective      When learning to tap to a rhythm the brain has to coordinate information from different     senses (eyes, ears, touch). This information has to be integrated into a movement plan to     allow a smooth, continuous performance. Two brain areas that are of particular interest for     this task are the posterior parietal cortex that integrates sensory and motor information and     the primary motor cortex that sends out the movement commands to the muscles. These areas     communicate via nerve connections with each other. The goal of this research proposal is to     examine if the strength of the connection between those areas can be changed by practicing a     simple tapping task and if the change in connection strength depends on if the rhythms were     shown by visual or auditory stimuli. Additionally we will investigate how the ability to tap     rhythms relates to other cognitive abilities like problem solving.      Study Population      We intend to study 20 adult healthy volunteers on an outpatient basis.      Design      In three experimental sessions we propose to use transcranial magnetic stimulation (TMS) and     electro encephalography (EEG) to examine the role of the posterior parietal cortex in motor     learning. In session 1 a neurological examination will be performed and a clinical and     anatomical MRI (Magnet Resonance Image) will be taken. Session 1 can be skipped if an MRI and     a neurological exam have been performed at the NIH during the last year. In session 2 TMS     will be used to examine the connection between posterior parietal cortex and primary motor     cortex before and after rhythm training. Additionally, EEG will be recorded during the     training session. In session 3 we will examine how the ability to tap to different beats     relates to higher cognitive functions. We will record EEG during tapping simple beats and we     will administer a pen and paper problem-solving test.      Outcome Measures      In session 2 the primary outcome measure will be change in conditioned Motor Evoked Potential     (MEP) peak-to-peak amplitude after learning temporal motor sequences measured in the primary     motor cortex. A secondary outcome measure will be the interregional coherence changes as     measured by EEG during training. In session 3 the primary outcome will be performance on the     tapping task and on the pen and paper test as well as the interregional coherence changes as     measured by EEG during the tapping task.   "
233051|NCT00904345|"     This is a single-arm, phase II trial to characterize the clinical outcome of standard of     care, cetuximab concurrent with radiation, in a special population (head and neck cancer     patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor     performance status or concurrent illness), and to determine if biomarker response to a     loading dose of cetuximab is predictive of that outcome.   "
233052|NCT00904358|"     To study the validity and reliability of estimation of the central venous pressure by     measurement of internal jugular vein size using 2-dimensional ultrasound.   "
233053|NCT00904371|"     The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood     pressure and its ability to reduce different indicated cardiovascular risks. Further on, the     study will evaluate the current antihypertensive treatment pattern in the daily practice     among the patient population at increased cardiovascular risk.   "
233054|NCT00904384|"     The prevalence of COPD in HIV+ and AIDS patients is unknown. The pathophysiology of HIV     infection and COPD might be of interest to both conditions. The research hypotheses of this     study are:      In patients with HIV infection living in the Autonomous Community of the Balearic Islands     (CAIB):        1. The Prevalence of airflow obstruction in patients with HIV infection is higher than in          the general population.        2. In these patients, the prevalence of emphysema detected by HRCT is common (greater than          or equal to 15%)        3. DLCO measurement is a good marker for the presence of emphysema on CT        4. The inflammatory response is different from that seen in patients with COPD and / or          emphysema without HIV infection   "
233055|NCT00904397|"     Patients who had axial lower back pain (LBP) with or without radiation present for at least 3     months and had daily moderate to severe LBP as the primary source of pain participated in a     Phase IV clinical trial to assess the efficacy of lidocaine patch 5% compared to celecoxib     200 mg in treating chronic axial LBP with and without radiation.   "
233056|NCT00904410|"     18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively     detect subclinical and clinical therapeutic responses at stages that are earlier than those     detected by conventional approaches.      We propose to conduct a prospective study to evaluate early therapeutic response using     18F-FDG PET before and after the 1st cycle of neo-adjuvant chemotherapy for breast cancer     patients.      Variation of 18F-FDG PET uptake is compared to clinical and echographical tumor response     evaluated after 3 cycles of chemotherapy.      The purpose is to estimate the capacity of 18F-FDG PET to differentiate responder and     non-responder patients.   "
233057|NCT00904423|"     Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include     bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might     be beneficial in treating these symptoms and to protect bone.   "
233070|NCT00904592|"     1. Title: A Study on TCM comprehensive protocol of Prevention and Control in Diabetic          Retinopathy.        2. Objectives of study: To evaluate the Intervention effect of integrate control protocol          on reducing the incidence rate of proliferative diabetic retinopathy, PRP and MVL. Then          produce a high performance, optimize, convenient, applicable and demonstrated protocol          of integrate control with Intervention of TCM and west medicine.        3. Study Type: Interventional        4. Study Design: Multi-center, Randomized, Blind (Subject, Investigator, Outcomes          Assessor), Parallel Assignment, Positive controlled clinical study.        5. Sample size: 480 subjects , divided into test and control groups equally.        6. Primary endpoint: incidence rate of proliferative diabetic retinopathy, panretinal          photocoagulation   "
233058|NCT00904436|"     Breathlessness is an extremely common and uncomfortable symptom that is reported in more than     two-thirds of persons with tetraplegia. This disordered pulmonary function is due to     respiratory muscle paralysis or to sympathetic denervation results in a restrictive     impairment and airway hyperreactivity, respectively. These restrictive and obstructive     dysfunctions have been associated with the symptom of breathlessness. However, mechanisms     contributing to dyspnea in persons who have tetraplegia are not well understood. It has been     demonstrated that persons with tetraplegia have an increased prevalence of breathlessness and     may have an altered breathing pattern. The purpose of this study is to determine the     breathing pattern at rest and measure the changes in breathing after a bronchodilator     treatment (a medicine commonly used to treat asthma that relaxes and opens up airways). The     determination of breathing pattern is done by measuring the movements in the chest wall while     breathing. This design will elucidate differences in breathing patterns between those with     tetraplegia and controls, as well as demonstrate the effect of bronchodilatation on motor     drive and timing. Knowledge of the intraindividual variability and mean values of the     components of the breathing pattern will improve our understanding of breathlessness in these     individuals.   "
233059|NCT00904449|"     The purpose of this study is to monitor the long-term analgesic effectiveness, safety, and     utility of oxymorphone ER for the relief of moderate to severe pain due to cancer.   "
233060|NCT00904462|"     Patients with unilateral or bilateral osteoarthritis (OA) of the knee participated in a Phase     II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo in the     treatment of pain from OA of the knee.   "
233061|NCT00904475|"     Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic     treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the     lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.   "
233062|NCT00904488|"     The purpose of this prospective, randomized, open-label study is to compare two diuretic     strategies in patients with acute decompensated heart failure (ADHF): the addition of an oral     thiazide diuretic to intravenous bolus (IVB) loop diuretic will be compared to transition     from IVB to continuous infusion (CI) loop diuretic.   "
235613|NCT00940901|"     This research is being done to evaluate if the phosphodiesterase type 5 (PDE5) inhibitor     sildenafil has an effect on the frequency of recurrent priapism and the quality of life of     males with sickle cell disease (SCD).   "
233063|NCT00904501|"     BALI (Bone marrow Autograft in Limb Ischemia) is a randomized double-blind trial comparing     implantation of bone marrow - mononuclear cells versus placebo in patients presenting with     critical leg ischemia and no surgical option.      The main end point is the survival without major amputation 6 months after implantation.      Biological studies are performed on bone marrow mononuclear cells (BM-MNC) to evaluate their     angiogenic properties.   "
233064|NCT00904514|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking at previously collected and stored tissue samples     from patients previously enrolled in a completed National Cancer Institute clinical trial.   "
233065|NCT00904527|"     The purpose of this study is to determine whether relaxation (autogenic training of Schultz)     is effective in treatment for migraine.   "
233066|NCT00904540|"     Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical     trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in     the treatment of acute and chronic LBP.   "
233067|NCT00904553|"     This study is to look more closely at the tumor removed during your surgery, and to follow     your condition after your treatment.      The purpose of this study is to determine what side effects are common or more rare from this     treatment, how well the treatment has worked for you, and to track whether you develop other     brain metastases.   "
233068|NCT00904566|"     By using gene-expression profiling, Van't Veer and colleagues developed a 70-gene prognosis     profile, MammaPrint, to identify breast cancer patients who are at low risk of developing     distant metastases and therefore might safely be spared chemotherapy. The aim of this study     is to evaluate the prognostic value of the 70-gene Mammaprint profile in Japanese women with     node-negative breast cancer.   "
233069|NCT00904579|"     Background:        -  Solid organ transplantation provides life-saving treatment for end-stage organ disease          but is associated with an increased cancer risk because of the need for long-term          immunosuppression        -  End-stage renal disease (ESRD), the most common type of end-stage organ disease leading          to transplant, is itself linked to increased risk for some cancers        -  The role of immunosuppression and other factors causing cancer in this setting are not          fully understood.      Objectives:        -  To characterize cancer risk in transplant recipients and identify risk factors.        -  To characterize risk for transmission of cancer from organ donors to recipients.        -  To describe cancer risk in ESRD.      Eligibility: Patients are not required for this study. Data are gathered from existing     databases of ESRD patients, organ transplant patients and cancer registries.      Design:        -  Databases of 1) U.S. transplant recipients, donors and wait list candidates and 2) U.S.          ESRD patients will be linked to multiple U.S. cancer registries to identify cancers in          transplant recipients and ESRD patients.        -  The spectrum of cancer risk in transplant recipients and ESRD patients will be evaluated          in detail.        -  The cancer risk in transplant recipients will be examined in relation to whether the          donors had cancer.        -  The proposed cancer risk factors (e.g., underlying medical condition, infection with          cancer-causing viruses, immunosuppressive medications) documented in transplant and ESRD          files will be studied for association with increased risk of particular types of cancer.   "
233071|NCT00904605|"     Patients with unilateral or bilateral osteoarthritis of the knee participated in a Phase IV     clinical trial to assess the efficacy of Lidoderm compared with celecoxib 200mg in treating     pain from osteoarthritis of the knee.   "
233072|NCT00904618|"     The objective was to observe the satisfaction of local anesthesia during the implantation of     the TVT-SECUR for the treatment of stress urinary incontinence, with the use of     questionnaires completed by the patients, and to evaluate the short-term efficacy and safety     of the sling, with a comparison of the two techniques of implantation: the 'U-Method' and the     'Hammock' technique.   "
233073|NCT00904631|"     Name of Device: Eraser Tattoo Removal Device      Device Description: The Eraser device is a mechanical device, resembling tattoo devices but     with an innovative mechanism for dripping treatment fluid over reciprocating needles and     returning used fluid into a reservoir chamber. The device is intended for removal of tattoos.      Objectives: This study is a continuation of a previous feasibility study, which tested the     ability of the device to remove tattoos from small skin areas. The purpose of this study is     to evaluate the safety and effectiveness of the Eraser Tattoo Removal system for removal of     skin tattoos in their entirety.      Subject Population: 20 patients in the medical center. Subject enrollment will include (i) a     variety of tattoo colors (multiple colors) (ii) a variety of tattoo composition, contour     lines and shadings (iii) Subjects with different skin colors (white, tanned, dark, etc…) (iv)     professional and amateur tattoos.      Structure: A prospective, non-randomized, open, clinical study designed according to FDA     guidelines; ISO 14155: standard for clinical studies of medical devices; and the procedures     of the Israeli Ministry of Health for clinical studies.      After informed consent is signed, demographic details and medical history will be taken and a     physical examination performed. Subjects will be treated with the Eraser device, using     salicylic acid (5%) as washing fluid. The skin will be examined by a physician and the tattoo     area will be photographed. The Eraser device will be used to remove the tattoo from the     entire tattoo area (up to 30 minutes in a single session). An absorbent bandage will be put     on the treated area for one-hour post treatment. After Care Treatment, based on a     Dermatologist's consultation, will be performed on a case-by-case basis (for example, use of     antibiotic ointments in case of infection). All subjects must refrain from exposure to the     sun for 90 days following each treatment.      Follow-up: The subject will return for follow-up at one week, two weeks, 1 month and two     months (if tattoo removal and skin healing is complete), or up to six months (if skin     healing/ tattoo removal are not complete by two months), or until the healing of the tattoo     removal site is completely resolved or until the investigator determines that additional     treatments will provide no further benefit to the patient. In each follow-up visit, a     physician will perform a physical examination, check the skin over and around the treatment     area, and take photographs of the treated area. Images from last follow-up will be compared     with images of the same site taken before the removal procedure, for evaluation of treatment     efficacy and safety.      Repeat treatments: if tattoo removal is not complete, up to two additional treatments will be     performed, based on the investigator's discretion. After each treatment, follow-up will     continue as described above.      Blinding: Non-Applicable Concurrent Control: There is no concurrent control group in this     study. Images of tattoos before treatment will serve as the reference measure, to which     images of healed skin, several weeks after tattoo removal, will be compared.      Sample Size: 20 subjects will be enrolled in the study. Primary Effectiveness Variables: The     primary measure of effectiveness will be the pigment clearance, as evaluated by image     comparison on a 1-5 analog scale (5 - 81-100% clearance- excellent removal; 4 - 61-80% - good     removal; 3 - 41-60% - moderate removal; 2 - 21-40% - fair removal; 1 - 0-20% - poor removal).     Effectiveness will be calculated for the total study group and for individual sub-groups     (skin type, pigment colors, etc.). Effectiveness will be analyzed separately for the area     affected (percentage of treated area that showed any reaction to treatment) and for the     change in color brightness (if, due to technical reasons, part of the tattoo showed a major     effect, this area will be evaluated for the change in color brightness). For both analyses,     the same scale will be used.      For safety assessment, the rate of systemic and dermatologic adverse events will be     calculated and reported. The data will be listed by type of event and by severity.     Specifically, textural change, hypo- and hyper- pigmentation will be followed and their rates     calculated.      Data Analysis: For this clinical study, descriptive statistics will be used. Successful     treatment will be a result of 3 or more (at least, moderate tattoo removal) on the brightness     change scale.      Study Sponsor: Hawk Medical Technologies Ltd.   "
233074|NCT00904644|"     Since June 2007, raltegravir has been available in Switzerland within a named patient program     for patients who have virologic failure, triple class experience and resistance, and no other     treatment options. This proposal has been designed to evaluate efficacy and safety data among     patients who receive raltegravir within the routine clinical practice in Switzerland and who     participate in the Swiss HIV Cohort Study. This is a combined retrospective analysis of     patients who already received raltegravir and a prospective part of patients who enter the     named patient program and will be followed up in a standardized way. In the prospective part,     patients will also be able to receive raltegravir in case of intolerance to their current     medication with virologic suppression.      The analysis will primarily use descriptive statistics. In addition, we will assess the     duration of virologic response and focus on predictors of HIV RNA suppression during a     follow-up of at least 6 months. In the prospective part, we will assess trough plasma levels     of raltegravir and other antiretrovirals. In patients who will develop virologic failure,     genotypic and phenotypic resistance to raltegravir (and other antiretrovirals) will be     performed to characterize the evolution of resistance during the raltegravir-containing     regimen.   "
233075|NCT00904657|"     The study is conducted:        -  to investigate the influence of sunitinib (study drug) on the plasma biomarkers VEGF-A,          VEGF-C, soluble VEGFR-2, and soluble VEGFR-3 (vessel endothelial growth factors) and on          the blood pressure;        -  to generate a pharmacokinetic/pharmacodynamic model for sunitinib using biomarkers.   "
233077|NCT00904683|"     Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized     by progressive decline in cognitive function and ability to perform activities of daily     living, and ultimately can lead to death due to complications of the disease. AD is thought     to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid     plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase     clearance, might be expected to slow the progression of AD.      LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1)     monoclonal antibody being developed for the treatment of AD. The primary hypothesis being     tested is that LY2062430 will slow cognitive and functional decline in AD as compared with     placebo. Each patient's participation will last approximately 19 months. Patients taking     approved AD medications may participate in this study and continue taking these medications     during the study.   "
233078|NCT00904696|"     Irritable bowel syndrome (IBS) is a very common chronic functional gastrointestinal disorder     characterised by abdominal pain/discomfort, bloating and alterations in bowel function. This     condition significantly impairs quality of life and places a large burden on health care     resources. Existing therapies for IBS are far from being satisfactory and new therapies are     being constantly sought.      The pathogenesis of IBS remains unclear. Imbalance in the intestinal microbiota is considered     to be one important etiologic factor for IBS. That some probiotics are effective in the     prevention and treatment of IBS supports this idea.      Progut is a synbiotic: a combination of probiotics and prebiotics. Probiotics are viable     beneficial bacteria that are normally present in a healthy digestive tract. Each capsule of     Progut contains 9 billion viable bacteria from 8 different strains that are characteristics     of a healthy normal gut microflora: Lactobacillus (L. acidophilus, L. casei, L. lactis, and     L. bulgaricus); Bifidobacterium (B. longum, B. infantis and B. bifidum); and Streptococcus     thermophilus at time of manufacturing. To ensure survival of these bacteria, Progut is     encapsulated and enteric-coated.      The primary objective is to evaluate the tolerability of Progut treatment 1-3 capsules/day in     patients with irritable bowel syndrome under the same conditions as those likely to be     encountered in a standard general clinical practice or outpatient clinic.      The rationale for this study is to obtain tolerability data in patients with IBS in the     Singapore. The secondary objectives are to evaluate the patients' satisfaction and symptom     improvement with Progut treatment.   "
233079|NCT00904709|"     Many women have heavy periods and this can be associated with low blood, tiredness and     inability to carry out normal activities. Approximately 10-30% of these women will have an     underlying bleeding disorder. There is a drug called tranexamic acid which is commonly used     and is effective in reducing menstrual flow. However, up to 1/3 of women have side effects     and they are more common at higher doses. In the medical literature, there are different     dosing schedules and there is one commonly recommended in Canada. Women with underlying     bleeding disorders may require higher doses of this medication compared to those who do not.     In this study, the investigators want to find the lowest effective dose of tranexamic acid     for girls and women with heavy periods who have bleeding disorders and the investigators     think this will be lower then the usual recommended dose. If the investigators' results     support this, it may contribute to changing how the investigators presently prescribe this     medication and may provide a better option for women with heavy periods in particular those     with bleeding disorders. The investigators have just started a Women with Bleeding Disorders     Clinic and hope that this project will lead to better care for the patients and more research     in the future.   "
233080|NCT00904722|"     The goal of this clinical research study is to learn if the combination of the immunotherapy     drugs, CT-011 and rituximab, can help control follicular lymphoma. The safety of this drug     combination will also be studied.   "
233081|NCT00904735|"     RATIONALE: Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. It is not yet known whether hydroxyurea is more effective when given alone     or together with imatinib mesylate in treating patients with meningioma.      PURPOSE: This randomized phase II trial is studying how well hydroxyurea works compared with     giving hydroxyurea together with imatinib mesylate in treating patients with recurrent or     progressive meningioma.   "
233082|NCT00904748|"     The purpose of this study is to perform a relative bioavailability study between two     formulations of sildenafil citrate.   "
233083|NCT00904761|"     This study aimed to investigate effects of physical training on exercise capacity and changes     of heart rate variability (HRV) at rest, during exercise, and post-exercise in the patient     with diabetes with autonomic neuropathy (DAN).   "
233792|NCT00915590|"     The purpose of this study is to determine the effectiveness and safety of     Interleukin-1-Receptor Antagonist eye drops for the treatment of corneal blood vessels.   "
233084|NCT00904774|"     Despite considerable obstetric and neonatal advances in the care of very low birth weight     (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of     surviving infants, and new ways for combatting this disease must be found. BPD appears to     result from arrested lung development, but its etiology has not yet been fully established.     Besides the role of the exposure of the immature lung to injurious factors in the development     of BPD, a genetic susceptibility for BPD in preterm infants was recently evidenced. Taking     advantage of new genomic technologies, the objective of the investigators' project is to     identify predisposing human genetic variants through:        1. a genome-wide association (GWA) study in VLBW neonates,        2. a candidate-gene association study, including selection of single nucleotide          polymorphisms (SNPs) found in (a) and        3. functional studies of any SNP found to be convincingly associated with BPD in (a) and          (b).   "
233085|NCT00904787|"     To define the maximum tolerated dose of oral daily ENMD 2076 in patients with relapsed or     refractory hematological malignancies   "
233086|NCT00904800|"     This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.   "
233100|NCT00904982|"     The purpose of this research study is to see if a lottery which provides the opportunity to     win money, a reminder system using a Med-eMonitor, or the combination of both might be     useful in helping patients to achieve better control of their anticoagulation therapy.     Selection for the arms of the study is randomized by the study computer. Some will     participate in the daily lottery only, some with the reminder system only, some with the     reminder system and the daily lottery, and some with neither the lottery nor the reminder     system.   "
233087|NCT00904813|"     There are theoretical reasons to believe that radiotherapy (RT) given in larger fractions     during a shorter period of time might result in more late side effects than giving a     conventional, more protracted RT in patients with rectal cancer. In addition, the optimum     timing of surgery after RT, with respect to postoperative morbidity, mortality and potential     downsizing of the tumour is not known.      To address these questions, a prospective randomized multicentre trial was initiated, the     Stockholm III trial, in which patients with primarily resectable rectal cancer were     randomized to short-course preoperative RT (5x5 Gy) followed by surgery within one week or     after 4-8 weeks or long-course preoperative RT(25x2 Gy) followed by surgery after 4-8 weeks.   "
233088|NCT00904826|"     The purpose of this study is to determine if the drug eculizumab reduces the attack rate and     improves outcome in patients with neuromyelitis optica.   "
233089|NCT00904839|"     The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in     combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line     patients with metastatic colorectal cancer.   "
233090|NCT00904852|"     This is a safety study of tandutinib in combination with temozolomide and bevacizumab after     people have received radiation therapy and temozolomide treatment. This study will determine     the maximum safe dose of tandutinib when combined with temozolomide and bevacizumab and     evaluate the safety of the combination treatment.   "
233091|NCT00904865|"     Background:      Single port access surgery is a rapidly progressing surgical approach which allows     performance of standard laparoscopic surgery through a single transparietal port instead of     multiple port accesses.      Objective:      Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple     ports laparoscopic cholecystectomy.      Hypothesis:      SPA cholecystectomy is associated with decreased parietal and body image trauma compare to     multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with     better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA     cholecystectomy may also be associated with decreased rate of parietal complications as lower     numbers of transparietal port are placed.      Methods:      All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in     the study will have recognized biliary pathology for which formal indication cholecystectomy     are recognized internationally.      Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy,     will be the same except, that one surgical technique is achieved through a single     transparietal port and the other through multiple ports.      Randomization will be performed before surgeries after patients have given their informed     consent to the study.      No specific test or cost will be necessitated by the study. Patients will be informed orally     and will receive a short study summary, allowing them to give an informed consent.      Endpoints:        -  Morbidity        -  Body image and Cosmetic results        -  Post-operative pain (opioid sparing effect)        -  Operative time        -  Hospital stay   "
233092|NCT00904878|"     A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with     Inflammatory Bowel Disease study is being conducted at the University of California San     Francisco and 30 other sites around the United States who are part of the CCFA Clinical     Alliance. The aim of this study is to determine the effect of medication use and disease     activity on the outcome of pregnancy among women with IBD up to 4 years from birth.   "
233093|NCT00904891|"     This study will test the effectiveness of two programs for preventing depression in     adolescents.   "
233094|NCT00904904|"     This study is being conducted to show that indomethacin is at least as effective as ketorolac     for the prevention of ocular inflammation following cataract surgery.   "
233095|NCT00904917|"     The purpose of the study is to adapt and test the Preventive Intervention Project for urban     African American mothers with depression and their children.   "
233112|NCT00905151|"     Current methods to assess kidney function have not been tested in people who have HIV/AIDS     population. Given effects of the disease as well as potential effects of the medications, it     is possible that the methods currently used to assess kidney function are not accurate. This     purpose of this study is to evaluate methods to assess kidney function the HIV population.     The investigators hypothesize that tenofovir causes a decrease in the secretion of creatinine     which would cause an elevation in blood levels without affecting actual glomerular filtration     rate (GFR).   "
233113|NCT00898417|"     RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment for     non-small cell lung cancer may help doctors predict how patients will respond to treatment.      PURPOSE: This laboratory study is looking at proteomic patterns in stored blood samples from     patients undergoing treatment for non-small cell lung cancer.   "
233833|NCT00918606|"     An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers.   "
233096|NCT00904930|"     Background/Aims: The Periotest® method represents a technique for objective tooth mobility     assessment. The aims of this study were: 1. receiving information about normal Periotest®     values in vertical and horizontal dimension on periodontally healthy teeth for individuals     aged 20-35, 2. investigating the reliability of the Periotest® method in terms of     intra-serial and inter-serial reproducibility before splinting and with an applied dental     trauma splint, 3. evaluating the splint effect of two different wire-composite splints in     vivo.      Materials and Methods: On periodontally healthy dental students (n=33; mean age 24.7 years)     Periotest® values were measured on reproducible measuring points, in vertical and horizontal     dimension and before splinting and after splint insertion. Three readings were taken per     serial to observe the intra-serial reproducibility, and for testing inter-serial     reproducibility three serials were measured (Friedman-test; P ≤ 0.001). Two different     wire-composite-splints (1 = Dentaflex 0.45 mm, 2 = Strengtheners 0.8x1.8) were inserted, the     Periotest® values were measured and the splint effects were calculated and compared     (Whitney-Mann-U-test; P ≤ 0.001).   "
233097|NCT00904943|"     The objective of this study was to compare the rate and extent of absorption of topiramate 25     mg capsules (test) versus Topamax® (reference) administered as 2 25 mg capsules under fed     conditions.   "
233098|NCT00904956|"     It is traditionally considered that someone with a positive tuberculin skin test (TST)     (and/or positive result in Cell Interferon-Gamma Release Assay (TIGRA), depending on the     different countries' guidelines) is infected but not ill when the absence of lesions is     demonstrated in a thorax X-Ray assay. Even though, the experiences described in literature     using cows and pigs as animal models for the study of LTBI demonstrate the presence of this     kind of lesion in the animals, even too small to be detected by X-Ray assay, which would     suggest they also could happen in human LTBI. Nowadays, the High Resolution Scanners (HR TC)     offer the possibility of detecting any lesion approximately 1 mm in diameter, so the     investigators plan to use this technique to screen people already infected by M. tuberculosis     (but not ill, following the Diagnosis Standard Guidelines).      Additional pathological analysis of resected and post-mortem tissues will provide     lesion-based profiles of humans infected with tuberculosis.   "
233099|NCT00904969|"     The purpose of this study is to obtain surgical technique data for use in physician education     and training and to collect early clinical outcomes data for future publication.   "
233805|NCT00915759|"     The purpose of this study is to evaluate the effect of ProKera on corneal wound healing after     photorefractive keratectomy (PRK) in terms of re-epithelialization, pain, adverse effects,     visual recovery, refractive accuracy, and corneal clarity.   "
233101|NCT00904995|"     Objectives:      To investigate the relationship between the administration of intravenous (IV) and oral     voriconazole (vori) and the occurrence of false positive (1,3) beta-d- glucan (BG) relative     to the standard assessment criteria used to diagnose invasive fungal infection in patients     with hematologic malignancies.   "
233102|NCT00905008|"     The FReIburger STent Registry (FRIST) is designed to determine the long term safety and     efficacy of Drug Eluting Stents (DES) in a real-world patient population requiring stent     implantation.      FRIST included patients treated with DES and bare-metal stents (BMS) in the University     Hospital of Freiburg, Germany, according to a non-restrictive inclusion criterion, in which     virtually all consecutive patient subsets were considered eligible.   "
233103|NCT00905021|"     The investigators want to find out if the treatments used in this study are helpful to     patients that are diagnosed with hormone receptor positive metastatic breast cancer. The     investigators want to also look at any side effects that could happen while patients are on     the study treatments. The investigators want to see if there are any changes that could show     us if your cancer is responding to the study treatments.   "
233104|NCT00905034|"     This goal of this clinical research study is to learn if the combination of methotrexate,     pegylated-L-asparaginase, vincristine, and dexamethasone (also rituximab in some patients)     can help to control ALL that has not responded to previous treatment or has come back after a     response or chronic myeloid leukemia (CML).   "
233105|NCT00905047|"     The scope of the trial is to determine the preference of patients, after randomization and     cross-over, for one of the two treatments.      Another objective of the trial is to assess and compare the safety of each treatment.   "
233106|NCT00905060|"     The Phase 2 trial is a single-arm investigation designed to evaluate safety, survival, and     immune response in patients treated with an autologous tumor-derived heat shock protein     peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly     for 4 consecutive weeks and monthly following standard treatment with radiation and     temozolomide.   "
233107|NCT00905073|"     The purpose of this study is to determine whether treatment with low dose cyclosporin and     methotrexate can inhibit the development of new onset diabetes mellitus   "
233108|NCT00905086|"     RATIONALE: Gathering information about psychological and social adjustment after radiation     therapy in patients with cancer may help doctors plan the best treatment.      PURPOSE: This clinical trial is studying psychosocial adjustment after radiation therapy in     patients with breast cancer, colorectal cancer, lung cancer, or prostate cancer.   "
233109|NCT00905112|"     The investigators propose such a trial to compare a Musculoskeletal and Obstetric Management     (MOM) program to standard obstetric care alone for lower back pain/pelvic pain (LBP/PP)     during and after pregnancy.   "
233110|NCT00905125|"     In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or     hospitalization. In the United States (US) it is recommend that all women get flu vaccine if     they are going to be pregnant or deliver during the flu season but only a few studies have     measured a pregnant woman's immune response (the body's defense against the flu) after     getting the flu vaccine. About 200, 18-39 year old, inclusive, pregnant women in their second     or third trimester (from 14 weeks of gestation to term, inclusive) will be enrolled in this     US based study. Participation will be about 8 months in duration. Women will be randomized     (assigned by chance) to receive either Fluzone® or Fluarix®. Blood collection will occur on     Day 0 and 28 days post vaccination.   "
233111|NCT00905138|"     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)     and multiple (MD) oral dose of GLPG0259 compared to placebo.      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple     oral administration will be evaluated, and, if applicable, the maximum tolerated dose     determined.   "
233114|NCT00898430|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at biomarkers in predicting response to treatment in     patients with newly diagnosed stage III or stage IV head and neck cancer treated with     carboplatin, paclitaxel, and radiation therapy.   "
233115|NCT00898443|"     This study is to study the success rate of using the epidural catheter that was placed during     the labor for the surgical anesthesia to perform a postpartum tubal ligation.   "
233116|NCT00898456|"     This research trial studies multidrug resistance genes in patients with acute myeloid     leukemia. Studying samples of bone marrow or blood from patients with cancer in the     laboratory may help doctors learn more about changes that may occur in deoxyribonucleic acid     (DNA) and identify biomarkers related to cancer. It may also help doctors learn more about     drug resistance and how patients respond to treatment.   "
233117|NCT00898469|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to bone     tissue death.      PURPOSE: This laboratory study is looking at risk factors for bone tissue death in young     patients with acute lymphoblastic leukemia treated on clinical trial CCG-1882.   "
233118|NCT00898482|"     RATIONALE: Collecting and storing samples of blood from patients with cancer and healthy     participants to test in the laboratory may help the study of cancer in the future.      PURPOSE: This study is collecting and storing samples of blood from patients with pancreatic     cancer and healthy participants.   "
233119|NCT00898495|"     RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict a patient's response to treatment.      PURPOSE: This laboratory study is looking at genes to see if they can predict outcome in     patients with esophageal cancer treated with cisplatin, radiation therapy, and surgery.   "
233120|NCT00898508|"     RATIONALE: Collecting and storing samples of blood and tumor tissue from patients with cancer     to test in the laboratory may help the study of cancer in the future.      PURPOSE: This clinical trial is studying blood and tumor tissue samples in women with     invasive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or benign breast     disease.   "
233121|NCT00898521|"     Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is     known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is     the source of local and/or systemic infection or sepsis. The local inflammation and infection     destroy healthy surrounding tissues and extends the original damage. In order to prevent     these complications, and in order to minimize the risk of infection, it is imperative to     evaluate the burn and remove all of the offending eschar at the earliest possible     opportunity. This removal of dead tissue is termed debridement.      The most direct debridement method for eschar removal is surgery. Traditional, conservative     non-surgical debridement is a lengthy process which often involves many complications.      The objectives of this study are as follows:        1. To evaluate the safety and efficacy (exploratory) of DGD in hospitalized patients with          Partial Thickness (mid and deep dermal) thermal burns of 4-30% total body surface area          (TBSA), but with total burn wounds of no more than 30% TBSA. Measures have already been          taken in previous studies involving deeper wounds to control safety parameters (such as          pain, fever and infection). Nevertheless, as part of the effort to expand the burn          population in the future phase 3 study to the more superficial wound group, it is          important to first explore these parameters in a small group involving this burn          population.        2. To explore DGD absorption as measured by Pharmacokinetic testing.   "
233122|NCT00898534|"     Immediate feedback of hemoglobin A1c (A1c) results to adults with type 1 and 2 diabetes     allows more appropriate care decisions at the clinic visit and may improve glycemic control.     The investigators' objective is to determine whether immediate feedback of A1c results to     children with type 1 diabetes will improve patient care and glycemic control.   "
233123|NCT00898547|"     RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the     laboratory may help doctors learn more about cancer and identify biomarkers related to     cancer.      PURPOSE: This laboratory study is looking at biomarkers of angiogenesis and disease in     patients with unresectable malignant mesothelioma treated on clinical trial CALGB-30107.   "
233124|NCT00898560|"     The purpose of this study is to investigate whether multiple-dose administration of     eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics     and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and     levonorgestrel).   "
233125|NCT00898573|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about cancer and the development of drug resistance in     patients.      PURPOSE: This research study is looking at lapatinib resistance in patients with breast     cancer.   "
233126|NCT00898599|"     Prebiotics are naturally occurring carbohydrates found in a variety of edible plants. They     are not digested by mammalian enzymes, and so reach the gut intact, where they are fermented     by some species of intestinal bacteria. This fermentation is thought to have several benefits     for the host including improving immune function. There are numerous methods available for     assessing the human immune response. Response to vaccination is thought to be a good method     for this. Not many studies have examined the effect of prebiotics on the human immune     response to vaccination. Thus the investigators propose to test the effect of a prebiotic on     the immune response in healthy volunteers including their response to the current flu     vaccine. The investigators hypothesise that the prebiotic will enhance the immune response     including the response to the vaccine.   "
233127|NCT00898612|"     RATIONALE: Studying samples of blood in the laboratory from patients who have undergone a     donor bone marrow transplant may help doctors learn more about changes that occur in DNA and     identify biomarkers related to graft-versus-host disease. It may also help doctors predict     how patients will respond to a donor bone marrow transplant.      PURPOSE: This laboratory study is looking at early detection of graft-versus-host disease in     patients undergoing a donor bone marrow transplant.   "
233128|NCT00898638|"     RATIONALE: Collecting and storing samples of tissue, saliva, and blood from patients with     cancer and from healthy participants to study in the laboratory may help the study of cancer     in the future.      PURPOSE: This research study is collecting and storing tissue samples from patients with head     and neck cancer and from healthy participants.   "
233129|NCT00898664|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This laboratory study is looking at DNA in tissue samples from patients with head     and neck cancer.   "
233130|NCT00898677|"     A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine     attacks and duration of relief provided. This study will also provide additional efficacy     data on rizatriptan 5 mg and 10 mg for the treatment of migraine.   "
233131|NCT00898690|"     RATIONALE: DNA analysis of tumor tissue may help doctors predict how patients who receive     paclitaxel will respond to treatment.      PURPOSE: This laboratory study is evaluating gene expression in predicting response to     paclitaxel in patients with breast cancer.   "
233132|NCT00898703|"     RATIONALE: Studying samples of blood in the laboratory from patients with current or previous     cancer may help doctors learn more about biomarkers related to cancer.      PURPOSE: This research study is looking at blood samples in women with breast cancer or a     history of breast cancer.   "
233133|NCT00898716|"     The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807     when administered orally on a once daily schedule in subjects with solid tumors.   "
233134|NCT00898742|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how will patients respond to treatment.      PURPOSE: This research study is looking at gene and protein expression patterns in predicting     response to cetuximab in patients with recurrent and/or metastatic head and neck cancer.   "
233135|NCT00898755|"     RATIONALE: Collecting and storing samples of tissue, blood, and bone marrow from patients     with cancer to study in the laboratory may help doctors learn more about changes that may     occur in DNA and identify biomarkers related to cancer.      PURPOSE: This laboratory study is collecting and storing tissue, blood, and bone marrow     samples from young patients with cancer.   "
233136|NCT00898768|"     Lynch syndrome (LS), or hereditary nonpolyposis colorectal cancer (HNPCC), is a hereditary     disorder characterized by a very high risk of early-onset colorectal and endometrial cancer     and an increased risk of other cancers, including cancers of the stomach, ovary, urinary     tract, hepatobiliary tract, pancreas and small bowel. This is a national multi-centre study     evaluating the yield of small bowel screening using capsule endoscopy (CE) and double balloon     enteroscopy (DBE) in Lynch syndrome subjects. The intervention consists of performing a     capsule endoscopy procedure at baseline and at 2-year follow-up. In patients with polyps or     malignant appearing abnormalities on capsule endoscopy, double balloon enteroscopy will be     performed with subsequent endoscopic or surgical removal of neoplastic lesions. The aim of     the study is to determine the prevalence and incidence of small bowel neoplasia in Lynch     syndrome patients using small bowel CE and DBE.   "
233137|NCT00898781|"     RATIONALE: Counting the number of circulating cancer cells in samples of blood from patients     with metastatic cancer may help doctors find out how much the cancer has spread.      PURPOSE: This research study is looking at the number of circulating cancer cells in patients     with metastatic breast cancer, ovarian cancer, colon cancer, or pancreatic cancer.   "
233138|NCT00898794|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about the effect of bevacizumab and VEGF on platelet clustering.      PURPOSE: This research study is looking at the effect of bevacizumab and VEGF on platelet     clustering in patients with cancer who are receiving bevacizumab.   "
233139|NCT00898807|"     The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation     in Alzheimer's dementia.   "
233140|NCT00898820|"     RATIONALE: Studying samples of blood in the laboratory from patients receiving pemetrexed     disodium may help doctors learn more about the effects of pemetrexed disodium on cells. It     may also help doctors understand how well patients respond to treatment.      PURPOSE: This laboratory study is looking at blood samples from patients with stage III or     stage IV non-small cell lung cancer enrolled in clinical trial MCCRC-RC0524 to determine the     effect of pemetrexed disodium on cells.   "
233141|NCT00898833|"     RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory     may help doctors identify and learn more about biomarkers related to cancer. It may also help     doctors predict how patients will respond to treatment.      PURPOSE: This laboratory study is measuring plasma and urine biomarkers in patients with     advanced prostate cancer that did not respond to hormone therapy.   "
233142|NCT00905164|"     The objective of this study was to compare the rate and extent of absorption of topiramate 25     mg capsules (test) versus Topamax® (reference) administered as 2 x 25 mg capsules under     fasting conditions.   "
233143|NCT00905177|"     The goal of this research study is to develop better dosing of anticoagulation medication in     both Caucasian and African Americans through analysis of various genetic factors.   "
233144|NCT00905190|"     This study is to assess the effect of food on a single dose of EUR-1025 when taken with a     meal and taken on an empty stomach.   "
233145|NCT00905203|"     The purpose of this study is specifically to investigate (1) the exercising muscle     oxygenation response in diabetic postmenopausal women; (2) the dose-response of different     physical activity interventions on skeletal muscle oxygenation response; (3) the related     mechanisms of training effects.   "
233146|NCT00905216|"     The objective of this study is to verify, through a randomized, single-blind, multicentre,     parallel and comparative study, the effectiveness of heparin sodium of porcine origin in     patients undergoing heart surgery that require the aid of cardiopulmonary bypass. The     effectiveness will be determined through the control of hemostasis during and after surgery,     based on the strengths of markers of coagulation trichloroacetic acid (TCA), alpha-tocopherol     transfer protein (TTPA), Anti-Xa, heparin bioavailability and excessive loss of blood     (bleeding) at the end of the surgery.   "
233147|NCT00905229|"     It is well known that femoral neck fractures carry a significant increase in patients'     mortality and that surgical intervention is the preferred treatment.      Any delay in operating on such patients would inevitably increase their risk of developing     complications. One of the reasons for such unintentional delay would be the hypercoagulative     status of patients taking warfarin. The CHEST 2008 guidelines suggest reversing warfarin with     Vitamin K for patients who need urgent operation. The aim of this study is to compare     different roots and doses of Vitamin K.   "
233148|NCT00905242|"     The purpose of this study is to determine whether maintenance renal transplant patients     receiving Myfortic can reduce or discontinue GI prophylaxis medications.   "
233149|NCT00905255|"     The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) used     as 2-step initiation regimen and 1-step initiation regimen in Japan, over a period of 24     weeks of treatment, followed by an extension up to Week 76.      The primary objective of this study is to evaluate the safety of lixisenatide once daily     treatment in monotherapy at Week 24 by a descriptive comparison of a 1-step initiation and a     2-step initiation regimen in patients with type 2 diabetes in Japan.      The secondary objectives are to assess the overall safety of lixisenatide once daily     treatment in monotherapy at Week 52 and Week 76; to assess the effects of lixisenatide on     glycosylated hemoglobin (HbA1c) reduction at Week 52 and Week 76, body weight, and fasting     plasma glucose (FPG); to assess pharmacokinetics (PK) and anti-lixisenatide antibody     development.   "
233382|NCT00902135|"     Aim of the BETAPATH study is to evaluate whether the use of a personal digital assistant     (PDA) can improve the adherence of Multiple Sclerosis patients to a therapy with Betaseron.     The Personal digital assistant PDA functions as an electronic diary and as an injection     reminder.   "
233150|NCT00905268|"     The purpose of this trial is to study the efficacy, safety and tolerability of idebenone in     12 months of treatment in children and adults with Friedreich's Ataxia. This is a randomised     placebo-controlled double-blind trial conducted in Europe. Efficacy outcomes include measures     of neurological impairment and function, and measures of the heart.   "
233151|NCT00905281|"     The purpose of this study is to assess the impact of systematic clinical cancer     department/supportive care department consultation meetings, versus standard care, on the     prescription of an additional line of chemotherapy in patients with metastatic breast cancer     and visceral involvement after 3 or 4 lines of chemotherapy.      This is a prospective paucicentric open label randomized controlled study with 2 parallel     arms.      Eligible patients will be randomly assigned to either arm Study group or Standard care.      The number of patients required to demonstrate a 30% reduction of the number of prescriptions     for an additional line chemotherapy, assuming an alpha risk of 5% and 80% power, is 100 (50     in each arm).   "
233152|NCT00905294|"     The purpose of this research is to determine the relationship between proteins and enzymes in     the blood and how they work with platelets to form blood clots in patients with coronary     artery disease. The investigators hypothesize that the relationship between these factors     could potentially be useful in identifying patients at higher risk for heart attacks.   "
233153|NCT00905307|"     This will be a multicenter, randomized, double-blind, placebo-controlled study designed to     assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment     of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20     mg) is included as a positive control to confirm the assay sensitivity of the study. A total     of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to     obtain approximately 450 randomized subjects.   "
233154|NCT00905320|"     This is a randomized study between two accepted techniques of mesh fixation for laparoscopic     hernia repair.   "
233155|NCT00905333|"     The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations     of candesartan and felodipine in a combination package comparing with the fasting intake of     commercial formulations of both Atacand ® and Splendil®   "
233156|NCT00905346|"     The objective of this study was to compare the rate and extent of absorption or topiramate 25     mg capsules (test) versus Topamax® (reference) administered as the content of 2 x 25 mg     capsules mixed with applesauce under fasting conditions.   "
233157|NCT00905359|"     The objective of the NICE study is to provide clinical evidence proving that the Aperius™     PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to     clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with     Neurogenic Intermittent Claudication, relieved by flexion.   "
233158|NCT00905372|"     Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized     by progressive decline in cognitive function and ability to perform activities of daily     living, and ultimately can lead to death due to complications of the disease. AD is thought     to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid     plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase     clearance, might be expected to slow the progression of AD.      LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1)     monoclonal antibody being developed for the treatment of AD. The primary hypothesis being     tested is that LY2062430 will slow cognitive and functional decline in AD as compared with     placebo. Each patient's participation will last approximately 19 months. Patients taking     approved AD medications may participate in this study and continue taking these medications     during the study.   "
233159|NCT00905385|"     The purpose of this study is to learn more about the safety of Haemophilus (H.) influenzae,     its ability to produce adverse reactions and to live in the nose and throat. The nose and     throat of healthy adults will be populated with a specific type of H. influenzae Nontypeable     Haemophilus influenzae (NTHi) 2019 Streptomycin Resistant (StrR) number 1. Researchers will     study whether the germ settles in the nose and throat, whether it causes symptoms after it     has been placed in the nose, how long the germs last in the nose and throat, and whether the     body tries to produce a permanent defense to the germ. Volunteers will receive a lower dose     (3,200 germs) or a higher dose (32,000 germs). Active participation will last about 28 days,     including a 3 night hospital stay, additional follow-up visits, followed by a 6 month     follow-up phone call. Study procedures will include blood samples, saliva samples, several     nose washes and throat swabs.   "
233160|NCT00905398|"     Patients with acute lymphoblastic leukemia and positivity for the breakpoint cluster     region-Abelson murine leukemia (BCR-ABL) protein or the Philadelphia chromosome have a poor     prognosis with standard chemotherapy. The prognosis seemed to improve following the adition     of imatinibe, a BCR-ABL inhibitor, to the treatment but still a substantial amount of     patients relapse or progress during treatment.      Nilotinib is a BCR-ABL inhibitor more potent than imatinib. It has been shown to be effective     against most of the cells that bear mutations of the BCR-ABL protein leading to resistance to     imatinibe.      The investigators' hypothesis is that the addition of nilotinib to a standard chemotherapy     for acute lymphoblastic leukemia (ALL) will translate into more rapid BCR-ABL reduction and     effectiveness against imatinib-resistant clones leading to less relapses and better survival.   "
233175|NCT00907621|"     Standardized acupuncture treatment for infant colic is a common treatment in general practice     for doctors educated in medical acupuncture.      The investigators plan to study whether the perceived opinion on positive results can be     verified in a multi-center clinical trial. The investigators aim to measure the effect of     standardized acupuncture treatment, three repeated sessions, on infant colic in a randomized     singe blinded prospective multi-center study, starting September 2009. The study will be done     in thirteen locations in Norway by specialists in General Practice trained in acupuncture.      The investigators intend to include a total of 130 patients, 65 in the intervention group and     65 in the control group.   "
233177|NCT00907660|"     We hypothesize that individuals provided with 1 meal per day of portion-controlled foods     (shakes and prepared entrees) will lose as much weight as individuals provided with 2 meals     per day of portion-controlled foods. The study is designed to assess whether equal weight     loss can be achieved at a lower cost to the health care system (or health care payer), with     patients contributing some of the cost of their own treatment.   "
233161|NCT00905411|"     The increasing prevalence of childhood overweight has been found to be related to decreased     levels of physical activity (PA) and increased energy content of the diet. Childhood offers     an opportunity to develop and support health-promoting behaviors. Pacific Kids DASH for     Health (PacDASH) is a community-based intervention that links food, PA, and health, and     targets overweight children in Hawaii with a goal of preventing further weight gain.     Components of the intervention include a food and PA prescription delivered by physicians at     community-based health centers complemented with a toolbox of activities, behaviorally     tailored messages, and PacDASH educational materials. This project will extend and apply the     nationally recommended DASH eating pattern to children and the growing population of Asians     and Pacific Islanders. The investigators will incorporate culturally preferred foods,     recipes, and PA messages that meet DASH and other national guidelines. The approach will     target child food behaviors and social and environmental cues that are important to making     healthy food and PA choices and will provide steps to behavior change. Farmers markets at     participating health centers are a support resource for activities. Providing access to,     coupons for, and guidance about selecting and preparing fresh fruits and vegetables at a     convenient health center farmers market will support increased intake of nutrient-rich foods     among these children who are overweight and at risk for obesity.      Pacific Islanders are among the world's most obese populations while Asians, although of     relatively low body mass index (BMI), carry much of their body fat in the upper body and     exhibit greater health risk at the same BMI. Through this project, the investigators hope to     learn more about body size and composition in children of the Pacific Region for whom there     are few national data. In addition, evaluate the effectiveness of a community-based     intervention within a health care system on managing overweight in children.   "
233162|NCT00905424|"     To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the     treatment of major depressive disorder (MDD) as measured by mean change in total     Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.   "
233163|NCT00905437|"     The purpose of this study is the investigate if pregabalin started a day before surgery and     continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and     post-operative anxiety and sleep disturbances.   "
233164|NCT00905450|"     This clinical study is being conducted to identify the most effective drug concentration and     dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of     inflammation following cataract surgery.   "
233165|NCT00905463|"     The purposes of the study are (1) to analyze the baseline patient characteristics     cross-sectionally, (2) to analyze the prognosis and its predictive factors and (3) to examine     the longitudinal clinical course in the lung transplant candidates in Japan.   "
233166|NCT00905476|"     The purposes of the present study are (1) to analyze baseline patient characteristics     cross-sectionally, (2) to analyze the prognosis and its predictive factors, and (3) to     examine longitudinal clinical course in patients with chronic respiratory failure receiving     domiciliary NPPV.   "
233167|NCT00905489|"     The primary objective is to establish the pharmacokinetic (PK) profile at steady state of     nevirapine XR in HIV infected children from >=3 to <18 years of age. This phase I trial is an     open-label, multiple dose, non-randomized and cross-over study. Patients who have completed     the last visit of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP)     until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved     and is available by prescription in a given country; or, the patient enrolls in a     compassionate use program. During this OEP, nevirapine XR safety and efficacy information     will be collected.   "
233168|NCT00907517|"     This study of SCH 900776 (MK-8776) will evaluate its safety and tolerability when given in     combination with cytarabine to participants with acute leukemias. Participants in the     Dose-Escalation Part will be enrolled in cohorts that will receive sequentially higher doses     of MK-8776 in combination with standard doses of cytarabine. Only one combination treatment     cycle of approximately 4 to 6 weeks is anticipated, but participants may receive additional     cycles if clinically indicated after discussion between the Investigator and the Sponsor. The     recommended combination doses for a Phase 2 trial (RP2D) will be determined based on safety     and biological activity. Up to 10 to 15 additional participants will be studied at the     combination RP2D.   "
233169|NCT00907530|"     This study is being conducted as a phase IV, double-blind, multi-center, randomized,     crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of     0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI)     and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.   "
233170|NCT00907543|"     The purpose of this study is to compare the results of preoperative chemotherapy and     radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation     for esophageal cancer.   "
233358|NCT00901823|"     This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment,     two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline     Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two     dose levels.   "
233171|NCT00907569|"     It is accepted that giving higher doses of chest radiation in as short a time span as     possible improves chances of cure. In this study, the investigators propose to give an     increased dose of chest radiotherapy for limited stage small cell lung cancer patients using     a strategy of giving a slightly higher daily dose of radiotherapy than normal. The     investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year     overall survival rates in patients with limited stage small cell lung cancer.   "
233172|NCT00907582|"     For relapsed acute promyelocytic leukemia after all-trans retinoic acid (ATRA) and arsenic     treatment, remission can be achieved by chemotherapy with ATRA and/or arsenic and addition of     mylotarg. Autologous hematopoietic cell transplantation using a polymerase chain reaction     (PCR) negative graft is important treatment option to obtain sustainable remission. This     study is to test the efficacy and the safety of conditioning regimen with idarubicin and     busulfan for relapsed Acute Promyelocytic Leukemia (APL).   "
233173|NCT00907595|"     The proposed study is a double-blind, placebo controlled pilot study of HD, PD, and DLB     subjects with sleep disturbances. This study is designed to determine the effects of 4 weeks     Ramelteon treatment on the sleep patterns of people with basal ganglia disorders such as HD,     PD and DLB. The study also aims to look at the sleep patterns of caregivers of people with     HD, PD and DLB.   "
233174|NCT00907608|"     The purpose of this study is to examine the effect of partial correction of anemia with     Darbepoetin alfa to a target of 11 g.dL (female) or 12 g/dL (male) on the reduction of     cardiovascular morbidity and total mortality.   "
233176|NCT00907634|"     The purpose of this study is to find out how the cervix normally moves during radiation     treatment. This study will also evaluate how cervical cancer shrinks during chemotherapy and     radiation. By better understanding these two things, the investigators can see if radiation     could safely be given in a more focused way in the future.      The investigational portion of this study includes (1) daily cone beam CT scans to confirm     transponder placement and evaluate tumor changes during treatment and (2) tracking movement     of the cervix during daily radiation treatment.   "
233179|NCT00907686|"     The spread of viruses through transfusions is the cause of serious illness and death in     recipients whose immune systems are unable to fight infection. Another group of patients     whose immune systems are underdeveloped and can be affected by a particular virus known as     cytomegalovirus (CMV) is low birthweight infants (LBWIs). CMV can be spread through the     placenta, during the birth process, through breast milk, while in the hospital or while     caring for someone carrying the virus as well as through a transfusion, known as     transfusion-transmitted (TT-CMV).      The spread of TT-CMV in LBWIs can be curtailed by transfusing blood products that are CMV     negative as well as to filter the white cells in blood that carry the virus (leukoreduction).     The purpose of this study is to see if the use of these two strategies can lower the spread     of CMV through a transfusion. How safe the blood actually is through leukoreduction is not     known and CMV still occurs in LBWIs. It is not clear whether this approach is optimal or     whether additional safety steps are needed to completely prevent TT-CMV. Specific actions     that could tell us when virus has reached the blood product or breast milk is to test each of     these to determine if virus slipped unnoticed and/or when the product was not thoroughly     filtered.      In this study, the investigators believe that the use of both prevention strategies will     result in a lower rate of TT-CMV, and that the cause of TT-CMV may be found in the presence     of CMV at the DNA level or by unfiltered white cells that remain in the blood product. Thus,     the most significant clinical question that remains to be addressed is whether this double     strategy for transfusion safety actually provides a zero CMV-risk blood supply or whether     further safety measures (DNA testing + 100% leukoreduction) must be used to protect this     extremely vulnerable patient group from CMV infection. This birth cohort study will be done     with 6 participating NICUs, and will study both CMV positive and negative mothers in order to     estimate the rate and pathway of CMV transmission to the LBWI who receives a transfusion.     Another study goal is to compare or link any CMV infection by either transfused units where     the virus was undetected, or filter failure. If CMV disease occurs, the investigators will be     able to describe the course and outcome in LBWIs who develop TT-CMV.   "
233180|NCT00907699|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and RNA and identify biomarkers     related to cancer.      PURPOSE: This laboratory study is looking at biomarkers in tumor tissue and blood samples     from patients with non-small cell lung cancer.   "
233181|NCT00907712|"     Vascular lower limb amputees have an increased morbidity and mortality. The aim of the study     is to evaluate the hemodynamic changes after amputation and its relation to outcome.   "
233182|NCT00907725|"     The purpose of this study is to evaluate if BhCG testing to determine the completion of     medical abortion simplifies the medical abortion protocol. Investigators hypothesize that     women randomized to ultrasonographic determination of completion of medical abortion will     have MORE follow-up visits/interventions beyond standard protocol than those randomized to     medical abortion follow-up with serum BhCG.      The investigators also hope to explore satisfaction with BhCG based follow-up among women     seeking medical abortion. Investigators hypothesize that the majority of women who choose to     follow-up with serum BhCG will be satisfied with this method of medical abortion follow-up.   "
233183|NCT00907738|"     This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683)     dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001,     MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving     this drug.   "
233184|NCT00907751|"     Multicentric non-randomized phase II opened prospective study (10 centres involved).      Primary endpoint:        -  To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in          patients treated with rituximab in association with plasma exchanges.      Secondary endpoints:        -  To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma          exchange sessions required to achieve a durable complete remission, and to determinate          the duration of B-cell depletion.        -  To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following          treatment with rituximab, as well as the incidence of relapses.   "
233185|NCT00907764|"     Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion     imaging. This study will test whether regadenoson is an appropriate stress agent for stress     echocardiography.   "
233211|NCT00908102|"     The purpose of this study is:        -  Epidemiological part: characteristics of low back pain patients from a forestry company          in Finland. Data is collected from occupational health databases and self administered          questionnaires.        -  Intervention: To determine the effectiveness and cost-effectiveness of several different          interventions in subacute low back pain (LBP) patients in occupational health (OH).   "
233359|NCT00901836|"     The goal of this study is to evaluate radiation treatment intended to increase the chance of     curing your sarcoma and decrease the side effects of proton therapy.      This study will also look at the tumor tissue that was removed during your initial biopsy and     your final surgery for information that may help to treat retroperitoneal sarcoma in the     future.   "
233186|NCT00907777|"     The aim of this study is to assess the immune response, safety and reactogenicity following     administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4     years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or     Prevenar™ vaccine within the first 6 months of life and a booster dose of plain     polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.      Antibody persistence will also be assessed at approximately 4 years of age in children     previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a     booster dose of Pneumovax 23™.      This protocol posting deals with objectives & outcome measures of the extension phase at year     4. The objectives & outcome measures of the primary phase are presented in a separate     protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are     presented in a separate protocol posting (NCT 00333450).   "
233187|NCT00907790|"     The aim of this study is test the efficacy of a comprehensive self-management therapy to     decrease abdominal pain/discomfort and improve quality of life in patients with irritable     bowel syndrome (IBS) compared to IBS patients receiving their usual care.   "
233188|NCT00907803|"     The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two     clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral     dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose     will be used in expanded pivotal safety trials.   "
233189|NCT00907816|"     Display of information regarding utilization and quality to primary care physicians as they     use our computer based system to order radiologic imaging (CT, MR, etc) will reduce     unnecessary imaging.   "
233190|NCT00907829|"     The purpose of this study is to determine whether neural block and neuromuscular electrical     stimulation are effective in treating finger impairment due to stroke.   "
233191|NCT00907842|"     Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and     the associated morbidity significant, standard placement of a prophylactic mesh upon stoma     creation might prevent parastomal (or incisional herniation, after closure) and improve the     quality of life of a large group of patients. This study is meant to be a pilot study to see     whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh     is placed intraperitoneally.   "
233255|NCT00908687|"     This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be     enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this     study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high     dose) on Day 0 with or without a patch (low or high dose).   "
233446|NCT00913016|"     To compare the overall QoL (Quality of Life) using Trial Outcome index (TOI) of FACT-B     questionnaire for 3 years from baseline.   "
233192|NCT00907855|"     Cardiac stress testing with functional nuclear imaging is an invaluable technique in the     diagnostic and prognostic evaluation of patients with known or suspected ischemic heart     disease. Selection of the appropriate type of nuclear stress test: exercise stress Myocardial     Perfusion Imaging (MPI) versus pharmacologic stress MPI is crucial for not only diagnostic     accuracy and prognostic evaluation, but also for sound clinical decisions and resource     utilization.      The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported     physical work capacity to estimate peak metabolic equivalents (METs) and has been shown to be     a valid measurement of functional capacity. The investigators hypothesized that the DASI may     be the screening tool that evaluates functional capacity and guides selection of the optimal     stress MPI study.   "
233193|NCT00907868|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known     whether whole-breast radiation therapy is more effective when given with or without     additional radiation therapy to the tumor in treating patients with ductal carcinoma in situ.      PURPOSE: This randomized phase III trial is studying breast-conserving surgery followed by     whole-breast radiation therapy to see how well it works when given with or without additional     radiation therapy to the tumor in treating women with ductal carcinoma in situ.   "
233194|NCT00907881|"     This study will assess the correlation between glycemic control and the hypoglycemia symptom     score in patients with Type 2 diabetes, 12 weeks after addition of a sulfonylurea to an     ongoing regime of oral hypoglycemic agents.   "
233195|NCT00907894|"     This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety     of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.   "
233196|NCT00907907|"     The objective of this study was to evaluate the comparative bioavailability between     Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg tablets (reference), after a     single-dose in healthy subjects under fasting conditions.   "
233197|NCT00907920|"     This research study is looking at tumor samples from young patients with neuroblastoma.     Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors     learn more about changes that occur in DNA and identify biomarkers related to cancer   "
233198|NCT00907933|"     This is a First Time in Human (FTIH) study to investigate the safety, tolerability and     pharmacokinetics (PK) of a) single, escalating and b) twice-daily 14 days repeat doses of     intranasal SB-705498 in healthy volunteers (HVT). The safety and tolerability of single     intranasal 498 dosing will be assessed and established before initiating the evaluation of     repeat intranasal 498 dosing.   "
233199|NCT00907946|"     The investigators are trying to determine whether placement of a nephrostomy tube prior to     definitive stone surgery and under ultrasonic or fluoroscopic guidance will reduce     complications related to bleeding and infection compare to obtaining renal access at the time     of surgery.   "
233200|NCT00907959|"     The investigators' proposed phase 2 clinical trial will be an open-label, non-randomized     study among 80 women with metastatic breast cancer. The study treatment period will be up to     twelve months and enrollment will be open at 10-15 clinical sites in the United States. In     this Phase 2 trial, 40 participants with hormone receptor positive tumors and 40 with hormone     receptor negative tumors will be enrolled and treated with BZL101 20 grams/day (10 grams     BID). Hormone receptor positive will be defined as estrogen receptor (ER)+ and progesterone     receptor (PR)+, ER+ and PR-, or ER- and PR+. Hormone receptor negative will be defined as ER-     and PR-.   "
233201|NCT00907972|"     Health care burdens from neurodegenerative diseases are expected to increase     disproportionately. Increasing age also predisposes this same population to other chronic     diseases including osteoporosis, a progressive systemic skeletal disease characterized by low     bone mass, which leads to an increase susceptibility to fractures. In the United States, 44     million people are estimated to be at risk for osteoporosis and low bone mass emphasizing the     enormity of this public health problem.      Parkinson's disease is a progressive neurodegenerative disorder affecting about 1 million     people. Evidence indicates that Parkinson's disease patients are at a higher risk for low     bone mineral density, which can contribute to increased fractures compared to healthy     subjects. In fact, several risk factors of osteoporosis in patients with PD have been     identified, including advanced stages of PD, low body mass index, inadequate sunlight     exposure and decreased vitamin D levels. Some or all of these factors in conjunction with     decreased immobilization that may occur with PD, put patients at increased risks for     fractures. Few studies however have examined bone markers in PD patients. Even fewer studies     have examined the impact of Vitamin D supplementation on bone metabolism and mineralization     in PD patients.      Vitamin D is an essential component in bone health, promoting calcium absorption in the gut     and maintaining adequate serum calcium and phosphate concentrations, which enable normal     mineralization of bone.   "
233202|NCT00907985|"     The purpose of this study is to investigate the effect of drug A on its own and when it is     given in combination with drug B on markers of brain activity. The study will        1. Assess the effects of drug A and drug B on muscle movement after brain stimulation;        2. Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A          and drug B when given in combination;        3. Examine the safety of drug A and drug B when given together.   "
233203|NCT00907998|"     The design of this study will enable an extensive evaluation of safety, tolerability, and     PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease   "
233204|NCT00908011|"     This study involves comparing the effectiveness of treatments in HIV positive patients who     may be predisposed to heart attack or stroke. The investigators will evaluate the     effectiveness of two drugs, often prescribed by doctors to these patients, at lowering     cholesterol and thereby making the patient less them less vulnerable to suffering a heart     attack or stroke. The investigators believe that the addition of a second drug, from a     different class of cholesterol lowering medications, will improve the outcome of the patients     by lowering cholesterol.   "
233205|NCT00908024|"     The study is expected to identify a safe dose of BMS-754807 to be given in combination with a     standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The     study is also intended to collect first data on the effects of the combination of BMS-754807     with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the     head and neck for whom cetuximab-containing therapies have not been effective   "
233206|NCT00908037|"     Phase II, multi-center, 3 part, staggered cohort, open-label and double blind, randomized,     placebo controlled study involving 3 age-determined cohorts (Cohort 1: between 12 and 17     years old; Cohort 2: between 6 and 11 years old; Cohort 3: between 1 and 5 years old). Daily     dosing with eltrombopag will begin with 5 patients in the oldest age cohort in an open label     fashion, and a review of safety, pharmacokinetic and platelet count data will be performed     regularly. If no safety concerns are identified after 12 weeks, 18 additional patients will     be randomised to placebo or eltrombopag (2:1 randomisation). After 7 weeks of randomized     treatment, all patients will receive eltrombopag in an open label fashion. The total duration     of treatment with eltrombopag will be 24 weeks. If at the time of the aforementioned 12 week     review of the first 5 patients no safety issues are identified, dosing will begin in the next     lower age cohort with an initial group of 5 patients. The same procedure will be followed in     terms of safety review and subsequent enrolment and randomisation of the additional patients.     Initiation of the younger age cohort will take place once data from the previous has been     evaluated. Doses will be adjusted according to platelet counts and tolerability. The study     will include a review of the safety data by a Data Safety Monitoring Board.   "
233207|NCT00908050|"     The purpose of this study is to determine whether botulinum toxin helps patients with     bruxism.   "
233208|NCT00908063|"     The primary objective of this study is to evaluate the safety and tolerability of a single     administration of Oxycyte in patients with severe non-penetrating traumatic brain injury     (TBI).      In the first dose level (Cohort 1), 11 patients were randomized 2:1 to receive either 1.0     mL/kg Oxycyte (0.6 g/kg; n=8) or NS (n=3). A total of 8 patients received Oxycyte. The Data     Safety Monitoring Board (DSMB) reviewed the safety data for patients in Cohort 1 through Day     14, and approved escalation to the next dose.      In Cohort 2, 18 patients will be randomized 2:1 to receive either 2.0 mL/kg Oxycyte (1.2     g/kg; n=12) or NS (n=6). The DSMB will then review the safety data for all patients in Cohort     2 through Day 14 and either approve escalation to the highest dose or remain at the current     dose. If remaining at the current dose level (Cohort 2) an additional 50 patients will be     randomized 1:1 to Oxycyte (n=25) or NS (n=25) and treated.      If escalation occurs to Cohort 3, 18 patients would be randomized 2:1 to Oxycyte (n=12) or NS     (n=6) to receive the 3.0 mL/kg dose. The DSMB would again review the safety data and decide     whether to treat an additional 50 patients at this dose or to decrease the dose back to 2.0     mL/kg. This group would be randomized 1:1 to receive Oxycyte (n=25) or NS.   "
233209|NCT00908076|"     The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe     and effective for chronic constipation, will also improve constipation symptoms in     Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in     bowel movement consistency, quality of life and motor symptoms.   "
233210|NCT00908089|"     The FIN-RACo trial is an investigator initiated multicenter (n=15 centers in Finland)     prospective study on the treatment of patients with early rheumatoid arthritis (RA) with     combination therapy with disease modifying antirheumatic drugs starting with methotrexate,     sulphasalazine, hydroxychloroquine and prednisolone (COMBI). During the first 6 months, the     patients are randomized to treatment with infliximab/placebo added on the combination     treatment. The study is prospective for 5 years, with extension to 10 years. The target is to     induce remission in both treatment arms. To reach this target, the investigators use frequent     changes of doses and anti-rheumatic drugs and use of intra-articular glucocorticoid     injections. The primary endpoints are the proportions of patients with remission at 2 and 5     years in both treatment arms.   "
233212|NCT00908115|"     The purpose of this study was to investigate the following questions through post-marketing     surveillance:        -  Unknown/Unexpected adverse events and the serious adverse events.        -  The circumstances in which the adverse events occurred under the practical application.        -  Factors considered to have influence on safety.        -  Factors considered to have influence on efficacy.        -  Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known          due to the inherent problems of the drugs.   "
233213|NCT00908128|"     The objective of this study was to evaluate the comparative bioavailability between     Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg Tablets (reference), after a     single-dose in healthy subjects under fed conditions.   "
233214|NCT00908141|"     RATIONALE: Colony stimulating factors, such as GM CSF, may increase the number of immune     cells found in bone marrow or peripheral blood. It is not yet known which GM-CSF regimen is     more effective in treating patients with prostate cancer.      PURPOSE: This randomized phase II trial is studying how well GM-CSF works in treating     patients with relapsed prostate cancer.   "
233215|NCT00908154|"     GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in     animal models.      This study is being conducted to obtain information regarding the safety, tolerability and     pharmacokinetics of repeated doses of GSK1014802 administered for up to 28 days in healthy     male or female subjects. In addition, the effect of food on the pharmacokinetics of     GSK1014802 will be investigated.   "
233216|NCT00908167|"     This is a Phase I study that determines a tolerable combination of sorafenib, when given     sequentially with cytarabine and clofarabine and determines the feasibility of administering     this drug combination in patients with relapsed or refractory hematologic malignancies     including acute myeloid leukemia (AML), acute promyelocytic leukemia (APL), acute     lymphoblastic leukemia (ALL), infantile leukemia (both either AML and/or ALL). AML with prior     myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasms, and     biphenotypic leukemia.   "
233267|NCT00908843|"     The purpose of this study is to compare the efficacy of oral versus intravenous hydration in     the prevention of the contrast-induced nephropathy.   "
233268|NCT00908856|"     This study will examine the safety of two different cellular therapies in the treatment of     stroke.   "
233447|NCT00913029|"     Prospective, unmasked, randomized evaluation of the iStent in patients with primary     open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2)     medication.   "
233217|NCT00908180|"     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of     cancer cells. It may also stop the patient's immune system from rejecting the donor's stem     cells. Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them     or deliver cancer-killing substances to them without harming normal cells. When the healthy     stem cells from a donor are infused into the patient they may help the patient's bone marrow     make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving cyclosporine before and after the transplant may stop this from happening. Once the     donated stem cells begin working, the patient's immune system may see the remaining cancer     cells as not belonging in the patient's body and destroy them (called graft-versus-tumor     effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may     boost this effect.      PURPOSE: This phase II trial is studying the side effects of giving carmustine together with     etoposide, cytarabine, melphalan, and alemtuzumab followed by donor stem cell transplant and     to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma.   "
233218|NCT00908193|"     The aim of this study is to prove the superiority of the robotic assistance in laparoscopic     repair of abdominal wall hernias .      In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce     the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.   "
233219|NCT00908206|"     This study will compare the effects of GSK598809 and placebo in alcohol dependent volunteers.     A placebo is a pill with no drug in it (i.e. dummy drug) but it is made to look exactly like     the real drug.      Subjects will be given one dose of GSK598809 during one visit and placebo during the other     visit. These dosing visits will be at least 1 week apart. The study is randomised, which     means that a computer programme will decide by chance (like tossing a coin), the order in     which subjects will receive GSK598809 or the placebo, or in other words, whether they will     receive GSK598809 or placebo first.      The study is blinded, which means the subjects will not know whether they are receiving study     drug or placebo first and neither will the doctors at the institute. If necessary for reasons     of safety, the study staff can find out exactly what the subject has received.      The study will last for approximately 4 weeks but could be up to 6 weeks, depending on length     of time between screening and dosing. From screening the subjects will be alcohol-abstinent,     they may be put on medication for treatment of withdrawal symptoms and then will have at     least 7 days without any medication before beginning the study medication. During the study     the subjects will be inpatients at the Central Institute of Mental Health. All subjects will     be required to fill out questionnaires, perform behavioural tasks and undergo MRI and     functional MRI (fMRI) scans.   "
233220|NCT00908219|"     The purpose of this study is to determine the effectiveness of using Bevacizumab in the     prevention of recurrent malignant ascites.      Ascites is a debilitating and unpleasant complication of several types of cancer. Animal and     laboratory studies have shown that tumor cell production and/or increases in the amount of     Vascular Endothelial Growth Factor (VEGF) is a major cause of the formation of malignant     ascites. Therefore, giving patients with malignant ascites a drug that targets and     neutralizes VEGF should prevent the recurrence of malignant ascites following paracentesis (a     procedure to remove fluid from the abdominal cavity).   "
233221|NCT00908232|"     The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide     or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that     have achieved a stable response after 4 initial cycles of treatment with VD. Multiple myeloma     is the second most common cancer of the blood. Bortezomib disrupts the life cycle of the     cell, affecting numerous biologic pathways, including those related to growth and survival of     cancer cells.   "
233222|NCT00908245|"     To evaluate the accuracy of ischemic preconditioning (IPC) as a protective maneuver against     ischemia/reperfusion lesion in patients undergoing major liver resection with intermittent     portal triad Clamping (IPTC).      Summary Background Data: For sake of safety and to avoid excessive blood loss during     parenchymal transection, vascular inflow occlusion is an effective trick but may cause     ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver     disease. IPTC has been proven to be superior to continuous hepatic pedicle clamping as it     preserve liver remnant from severe ischemia/reperfusion lesion, so does IPC. Yet, if IPC is     beneficial if liver resection is performed under IPTC has never been demonstrated in a     randomised controlled trial (RCT). The investigators designed a RCT to assess the impact of     IPC in patient undergoing major liver resection with intermittent vascular inflow occlusion.   "
233223|NCT00908271|"     The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.   "
233224|NCT00908284|"     People infected with HIV are now living longer lives because of the use of highly active     antiretroviral therapy (HAART). However, HAART medications have been shown to increase the     risk of cardiovascular disease and metabolic dysfunction in adults. More research is needed     on the effect of HAART in children. The purpose of this study is to assess cardiovascular     risk factors in children infected with HIV who receive HAART medications and to determine the     effectiveness of an exercise program on cardiovascular outcomes in these children.   "
233225|NCT00908297|"     The purpose of this study is to determine the safety and tolerability of the dietary     supplement Coenzyme Q10 in hemodialysis patients.   "
233226|NCT00908310|"     This will be an international, multi-center, post-marketing surveillance study in patients     with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI.     Omniscan will be administered intravenously at the medical discretion of the prescribing     physician.   "
233227|NCT00908323|"     HVTN 908 is a sub study of the HIV vaccine trial, HVTN 205. The purpose of this sub study is     to better understand how a person's immune system responds to vaccines, particularly HIV     vaccines. More specifically, researchers will determine whether early responses in the immune     system help predict strong and long-lasting immunity.   "
233282|NCT00909038|"     It is a national, retrospective , observational study in hypertensive patients treated for at     least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25     mg. The primary objective is to assess the control rate (systolic and diastolic blood     pressure). Key secondary objectives are to assess the blood pressure reduction after at least     8 weeks of treatment, describe the population treated with this new fixed dose combination   "
233228|NCT00908336|"     Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition     of erlotinib to chemotherapy has not achieved better results in the general population.      However, several preclinical and phase I studies have shown that a sequential treatment of     erlotinib and chemotherapy could avoid a possible negative interaction between both drugs     when administrated concomitantly, and therefore, it could improve the benefit of the     combination therapy.      This study will investigate if the intermittent treatment of a chemotherapy drug, such as     docetaxel, with erlotinib could achieve a clinical benefit.   "
233229|NCT00908349|"     Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine     Extended-Release (OXC XR)   "
233230|NCT00908362|"     Airway dendritic cells (DCs) play a key role in smoke-related lung diseases. In this study,     the researchers investigate the effects of fluticasone and salmeterol on human airway DCs in     smokers. The researchers hypothesize that fluticasone and salmeterol impact on the number and     the characteristics of airway DCs in smokers.   "
233231|NCT00908375|"     The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain     in patients who present with radicular pain due to a herniated disc, spinal stenosis or     failed back surgery syndrome.   "
233232|NCT00908388|"     The primary objective of this study is to determine the safety and efficacy of the GORE     Conformable TAG Thoracic Endoprosthesis (CTAG) for treatment of subjects with acute     complicated type B aortic dissection.   "
233233|NCT00908401|"     Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid     procedural pain in preterm neonates.      The objective is to test this hypothesis in a randomized, controlled study using a     standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each     two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from     80% with oral sucrose to 40% with breastmilk.   "
233234|NCT00908414|"     The purpose of the study is to determine the safety, tolerability, and plasma     pharmacokinetics (i.e., the levels of TMC589337 and TMC589354 circulating in your blood over     time) of increasing single oral doses of TMC589337 and TMC589354 and of multiple increasing     oral doses followed by a single dose of TMC310911 to assess the potential boosting effect on     the latter compound. In this study 3 investigational new drugs are involved. These new     investigational drugs called TMC589337 and TMC589354 (from the PEPI family) and TMC310911 are     in process of development for the treatment of Human Immunodeficiency Virus-Type 1 (HIV-1).     TMC589337 and TMC589354 are novel molecules with no antiviral activity to be used to enhance     the pharmacokinetics profile of a drug. TMC310911 is a novel and potent compound and belongs     to a medication class called protease inhibitors (PI).   "
233235|NCT00908427|"     The purpose of this study is to compared the efficacy of 80W KTP photoselective laser     vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in     reducing the volume of prostate and relieving the obstruction in men with benign prostatic     hyperplasia (BPH) on non-randomized controlled design.   "
233248|NCT00908596|"     Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging     (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to     participate.      The administration of contrast agents that contain gadolinium such as Primovist/Eovist might     increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis     (NSF) in patients with renal impairment. This study is to assess the potential risk to     develop NSF in patients with renal impairment after the administration of Primovist/Eovist.      Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan     which was prescribed by the referring doctor. After the MRI scan the patient will be included     in a two year follow-up period to assess if signs or symptoms suggestive of NSF have     appeared.   "
233236|NCT00908440|"     The purpose of this study is to examine the effects of a decision aid on veterans with     posttraumatic stress disorder (PTSD) presenting for care. The investigators' primary     hypothesis is that patients assigned to use the decision aid will demonstrate improved     quality of decisions regarding PTSD treatment relative to patients assigned to usual care.     Improved decision quality will be examined by assessing patient's knowledge of treatments,     evaluation of the risk and benefits, ability to arrive at a decision, and certainty about     that decision. The investigators' secondary hypothesis is that patients assigned to the     decision aid will be more satisfied with their care and more compliant with their care     compared to patients assigned to receive usual care. The investigators will also determine     whether patients assigned to the decision aid, relative to patients assigned to usual care,     are more likely to receive evidence-based treatments for PTSD and experience reductions in     PTSD symptoms.   "
233237|NCT00908453|"     The study is to evaluate safety, efficacy and pharmacokinetics of intravenously administered     fosphenytoin in patients with neurosurgery, head trauma, epilepsy or status epilepticus who     are requiring a loading dose of phenytoin.   "
233238|NCT00908466|"     The purpose of this study is to find out about the safety and effectiveness of the study     drug, sirolimus, in patients with uveitis and to utilize the potential effectiveness of     sirolimus, and yet to avoid the potential complications of systemic use of the drug. In this     study, the investigators will administer sirolimus either around (subconjunctival injection)     or inside the eye (intravitreal injection). Local administration of sirolimus to the eye is     not expected to have effects on the rest of the body. Therefore, it may offer a safer way     than the current methods used to control the inflammation caused by non-infectious uveitis.   "
233239|NCT00908479|"     This study would focus on a new method of adding extra leg homework exercises to the usual     therapy delivered in the hospital. We propose to design an exercise program for the affected     leg that would be given to the client as homework and done in the client's hospital room or     ward. The program would be designed and monitored by a therapist that works in the hospital.   "
233240|NCT00908492|"     The purpose of this study is to pilot the home Environmental Skill-Building Program (ESP) and     an educational control intervention with persons with dementia and their caregivers (n=40) in     preparation for a larger double-blind randomized controlled trial. Caregivers of persons with     dementia often deal with difficult behaviors. The ESP is an occupational therapy intervention     that helps caregivers adapt to their environment and build care-giving skills. The areas     addressed include changes to the home set-up, adaptive equipment, instruction in strategies     of problem-solving, energy conservation, safe task performance, and fall recovery techniques.     A trial is needed with methodological rigor and to determine if the intervention is feasible     in the Canadian health care system. Results will contribute to understanding how caregivers     and people with dementia can be supported in their home environments.   "
233241|NCT00908505|"     The purpose of this study is to compare the effectiveness of different mucous clearance     techniques in cystic fibrosis patients   "
233283|NCT00909051|"     Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in     a large sample of patients.   "
233284|NCT00909064|"     The investigators hypothesize that Arixtra patients will be less likely to experience wound     infection than patients who have received low-molecular weight heparin, coumadin or aspirin     with mechanical compression.   "
233242|NCT00908518|"     The progressive aging of the general population cause increase in number of extensive and     long surgeries in older patients. Age is a risk factor for perioperative myocardial ischemia     and Postoperative Cognitive Dysfunction (POCD) The suggested study will deal with the     above-mentioned complication in patients older then 65 years undergoing major non-cardiac     surgeries.      It has been shown that Isoflurane and sevoflurane may have a cardio-protective effect after     cardiac surgery involving cardio-pulmonary bypass, and it was recommended that isoflurane     should be used in these cases. A question was raised but haven't been answered yet, whether     this cardio-protective effect exists also in non-cardiac major surgery.      The aim of this study is to evaluate whether there is a difference in the occurrence of     postoperative cognitive dysfunction and perioperative myocardial ischemia between total     intravenous anesthesia using propofol and isoflurane based anesthesia.   "
233243|NCT00908531|"     The hypothesis to be addressed in this randomized phase III trial is that 4 months of     letrozole may be superior to surgery as primary therapy for early stage hormone receptor     positive breast cancer in postmenopausal women, provided that these patients will receive     definitive and radical surgery and adjuvant therapies as otherwise indicated at the     completion of preoperative letrozole.   "
233244|NCT00908544|"     This is a multi-center, open-label, non-randomized proof-of-concept trial. Two cooperating     HIV-specialized centres represented by Dr. med. Hans Jaeger and Prof. Dr. Johannes Bogner are     planning to perform an IIT (investigator initiated trial) with the goal to eradicate HIV in     N=40 HIV-infected patients with either primary infection or chronic infection and successful     HAART (Highly Active Antiretroviral Treatment) of several years.      All patients will be started on a multi-drug HAART including two     Nucleoside-Reverse-Transcriptase-Inhibitors (NRTI´s), one Protease-Inhibitor (PI), a     CCR5-inhibitor and an Integrase-Inhibitor (INI). Decay of viral reservoirs like latently     HIV-infected CD4+ T-cells will be monitored over time.   "
233245|NCT00908557|"     The principle objective of this randomised controlled trial is to assess whether an     improvement in lexico-syntactic readability combined with adherence to French recommendations     for good practice in writing the Information and Consent Form (ICF) given to patients     participating in clinical trials, increases their understanding of the information compared     to conventional written information, in real (not simulated) conditions.   "
233246|NCT00908570|"     The purpose of this Phase I study is to investigate and document the effects of local     treatment with a topical estriol cream on the vaginal environment of pre-menopausal women.   "
233247|NCT00908583|"     To determine if deletional strategies will provide effective desensitization.   "
233320|NCT00909545|"     The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable     and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies.   "
234561|NCT00917878|"     The purpose of this study is to determine whether the addition of milk or the milk     constituents calcium and protein to a high-fat breakfast affects the postprandial lipid and     inflammatory response.   "
233249|NCT00908609|"     The investigators propose to validate the utility of their novel hybrid imaging technique for     accurate diagnosis of breast lesions, and for assessing chemotherapy response of cancer     treatment and predicting treatment efficacy. The investigators' unique hybrid technique is     implemented by simultaneously deploying near infrared (NIR) optical sensors and a commercial     ultrasound (US) transducer mounted on a hand-held probe, and utilizing co-registered lesion     structure information provided by ultrasound to improve the optical tomography.      As a result, the optical tomography assisted with US has overcome problems associated with     intense light scattering and has provided reliable tumor angiogenesis distributions. Initial     results with a small group of patients who underwent biopsy have shown that early stage     invasive cancers present two-fold greater total hemoglobin concentration on average than     fibroadenomas and other benign lesions. Initial results of advanced cancers have shown that     the angiogenesis distribution is highly distorted and heterogeneous, and the distorted     distributions correlate with histological microvessel density counts and can be used to     assess chemotherapy response.      The objective of this study is to validate the investigators' initial results that NIR light     guided by ultrasound can improve breast cancer diagnosis and monitor chemotherapy response.   "
233250|NCT00908622|"     The purpose of this study is compare the improvement in global and regional cardiac function     measured by echocardiography and magnetic resonance in patients with old myocardial     infarction subject to cardiac catheterisation with percutaneous endocavity implantation of     autologous myoblasts.   "
233251|NCT00908635|"     This study is designated to determine serum concentrations of inflammatory mediators Ang-1,     Ang-2, Ang-1/Ang-2 ratio, and Tie-2 in patients with sepsis-induced MODS and to investigate     the association among increased permeability, inflammatory mediators, and these serum     mediators in development of organ failure.   "
233252|NCT00908648|"     Narrow band imaging (NBI) is an imaging technique that allows a better definition of     capillary pattern and improves the contrast between adenomas and the surrounding mucosa.     Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the     impact of NBI is being tested in several screening scenarios. The investigators evaluated     whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of     screening colonoscopy improved adenoma detection.   "
233253|NCT00908661|"     The purpose of this study is to determine if a mesh is effective in the prevention of a     parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.   "
233254|NCT00908674|"     Androcur is an antiandrogenic drug, which blocks the action of male sex hormones. Androcur is     used for treatment of advanced prostate cancer. This study investigates the effect of     Androcur on quality of life of prostate cancer patients who are taking the drug for 12 months   "
233550|NCT00914368|"     The primary objective of this study is to establish a cut off level of platelet inhibition     that separates patients with or without previous stent occlusion with acute clinical onset     while on aspirin and clopidogrel treatment within 6 months after coronary stenting for     coronary artery disease.   "
233256|NCT00908700|"     A pilot, multicentre randomized controlled study of surgical left atrial occlusion (LAA) in     50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring     cardiopulmonary bypass with additional risk factors for late stroke.      Patients will be enrolled and randomized to undergo LAA exclusion and aspirin therapy or best     medical therapy as per guidelines.      Main research questions:        1. Can successful occlusion of the LAA be safely achieved by cut and sew or stapler          techniques?        2. In patients with atrial fibrillation with 2 or more risk factors for stroke, will          removal of the left atrial appendage (LAA) and aspirin therapy reduce the risk of          systemic embolic events and major bleeding compared to warfarin?   "
233257|NCT00908713|"     The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy     in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the     study is that glucocorticoids can modulate the excessive inflammatory response in patients     with severe CAP without any significant side effects, showing a benefit in the percentage of     non-response to the empiric antimicrobial treatment.   "
233258|NCT00908726|"     AquafolTM (Daewon Pharmaceutical Co., Ltd., Seoul, Korea) is a microemulsion propofol that     has been developed for eliminating lipid solvent-related adverse events of long chain     triglyceride emulsion (LCT) propofol (Diprivan®; AstraZeneca, London, United Kingdom), such     as infection, fat embolism, hypertriglyceridemia and pancreatitis. Originally, AquafolTM was     formulated with 8% polyethylene glycol 660 hydroxystearate (Solutol HS 15, BASF Company Ltd.,     Seoul, Korea) and 5% tetrahydrofurfuryl alcohol polyethylene glycol ether (Glycofurol, Roche,     Basle, Switzerland). A phase 1 study to assess the safety and tolerability of polymeric     vehicles of this formulation in healthy volunteers showed dose-limiting toxicity.     Subsequently, it was reformulated with 10% purified poloxamer 188 (PP188) as a nonionic block     copolymer surfactant and 0.7% polyethylene glycol 660 hydroxystearate as a nonionic     surfactant. Alterations in propofol formulation may result in altered pharmacokinetic,     pharmacodynamic characteristics.      The aim of this study was to compare the pharmacokinetics and pharmacodynamics of propofol     microemulsion and lipid emulsion, using noncompartmental analysis and population analysis     with mixed effects modeling.   "
233259|NCT00908739|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is looking at tumor tissue samples from patients who have     undergone surgery for localized kidney cancer.   "
233260|NCT00908752|"     The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive     brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive     matched placebo with TACE therapy.   "
233261|NCT00908765|"     Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise     intolerance are ventilatory limitation leading to deconditioning and inactivity. So far it is     poorly understood which form of exercise is the most effective in training this condition.     The investigators want to study the physiological response to two different training programs     (High intensity aerobe interval training and moderate continuous aerobe training)with special     focus on cardiac and skeletal muscle adaptions   "
233262|NCT00908778|"     The purpose of this study is to determine the safety and efficacy of Vitreosolve® in diabetic     retinopathy patients.   "
233263|NCT00908791|"     Conjugated Linoleic Acid (CLA) is obtained in the human diet by consumption of foods     containing ruminant fat. Milk and dairy products have shown the highest amounts of CLA.     Clarinol (CLA), is considered a natural supplement and is not regulated by the Food and Drug     Administration (FDA). CLA is known to inhibit proliferation of human breast cancer cells and     tumors in rodent breast cancer models and reduced Spot 14 (THRSP, S14) and Fatty Acid     Synthase (FASN) gene expression in breast cancer cells and tht the two major CLA isomers used     in nutritional supplements (C9, t11 and t10, c12) were equipotent in reducing breast cancer     cell growth. This study looks at the hypothesis that S14 expression is decreased by CLA and     will characterize the major pharmacodynamic (PD) effects of CLA in newly diagnosed Breast     cancer patients on Tumor tissue lipogenic pathway. FASN, S14 and Lipoprotein Lipase (LPL),     Ki67 and apoptotic index expression will be assessed by quantitative immunohistochemistry     (IHC) in initial breast cancer biopsies and compared to that in resected breast tumor tissue     after the study subject has been taking CLA for ten to twenty-eight days. Tissue from     adjacent breast adipocytes will also be analyzed to determine whether adipose tissue effects     can serve as a surrogate marker for those in tumor tissue. A sample of the original biopsy     will be compared to the tumor resection sample to determine the levels of CLA in the breast     cancer cells.   "
233264|NCT00908804|"     The aim of this prospective randomized trial is to compare the feasibility of open with     laparoscopic appendectomy in suspected acute appendicitis. The investigators especially     focused on the postoperative recovery and long-term complications.   "
233265|NCT00908817|"     The purpose of this study is to determine whether triamcinolone paste applied over tracheal     tube is effective to reduce the incidence of postoperative sore throat after tracheal     intubation.   "
233266|NCT00908830|"     Lung transplantation is a life saving procedure for patients with a terminal lung disease     such as cystic fibrosis. Approximately, one in 3,500 children in the United States are born     with cystic fibrosis each year with the predicted survival reaching 36.9 years in 2006.     Cystic fibrosis was the third lead indication for lung transplantation in 2006. Cystic     fibrosis is a genetic disease that can affect the way the body can remove salt from various     organs. It results in mucus blocking the ducts of the lungs and pancreas leading to inability     to handle oxygen and malabsorption of nutrients. Malabsorption is a common complication of     cystic fibrosis that can affect the way the anti-rejection medications are absorbed. One     medication that is utilized after transplant to prevent rejection is mycophenolate mofetil.     This medication may not be absorbed adequately in this population due to their disease thus     placing these patients at increased risk of rejection. At the investigators' institution, all     transplant patients are initiated at the same mycophenolate dose regardless of their     underlying disease. The limited available literature regarding cystic fibrosis transplant     patients and mycophenolate suggests that these patients require higher doses due to their     erratic absorption. The purpose of this study is to evaluate the effects of mycophenolate     mofetil on the body in lung transplant patients who have cystic fibrosis in efforts to     improve survival outcomes.   "
233269|NCT00908869|"     Purpose:      This phase I trial estimates the antiangiogenic and antivascular effect of 4 different levels     of continuous low doses of the combination of Vinorelbine, Cyclophosphamide and Interferon     alpha 2b ( metronomic chemotherapy )in adult advanced neoplasm.      This study is non randomized, monocentric, and with a pharmacodynamic part.      Primary objective:      Estimation of the toxicity of the combination of continuous low doses of Vinorelbine,     Cyclophosphamide and Interferon alpha 2b.      Secondary objectives:      Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography     (DEC-MRI), biology and immunohistochemistry of the treatment.   "
233270|NCT00908882|"     The goal of this study is to improve the effectiveness of tobacco cessation treatment for     veterans with Post Traumatic Stress Disorder (PTSD) through ongoing, integrated care     management approach using telehealth and motivational interviewing counseling. Both tobacco     dependence and PTSD represent enormous challenges to the Veterans Affairs (VA) healthcare     system.   "
233271|NCT00908895|"     The treatment of extra-articular distal radius fractures is still controversial. In Canada,     most patients with unstable fractures are treated with pinning and cast. Results are often     associated with shortening and lack of function.      The purpose of the study is to compare stabilization with a radio-radial fixator to the usual     method, suggesting that the radio-radial fixator will provide more strength at 6 months     follow-up.   "
233272|NCT00908908|"     The purpose of this study is to determine the metabolism and elimination of carbon-14 labeled     eribulin acetate (14C-eribulin) in patients with advanced solid tumors.   "
233273|NCT00908921|"     To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD     initiation mono-therapy in type 2 diabetic patients in China.   "
233274|NCT00908934|"     The aims of this study are to compare the blood levels achieved with a new formulation of     AZD9056 to an existing formulation of AZD9056 used in previous studies.   "
233275|NCT00908947|"     The objectives of this study are to collect post-market confirmatory evidence of the safety     and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular     Stent System (together the LifeStent® Vascular Stent System).   "
233276|NCT00908960|"     Research studies have shown a strong association between cancer and blood clots in the veins     (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary     embolism) which in severe cases may be life threatening. The purpose of this research study     is to see if enoxaparin is effective in preventing blood clots in the veins in participants     who have cancer of the pancreas, colorectal, non-small cell lung, ovary, or gastric and also     have high levels of tissue factor bearing microparticles in their blood (TFMP). TFMP are     small particles that are generated from different types of blood cells in the body. In people     who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk     factor for deep vein thrombosis. Enoxaparin has been used to prevent formation of blood clots     in patients after abdominal or orthopedic surgery and in patients who suffer from a severe     medical illness. Based on these studies, we are investigating to see if it prevents     thrombosis in people with certain types of cancer.   "
233277|NCT00908973|"     The aim of the study is to describe differences in meal-stimulated gut hormone response,     appetite and intestinal transit time between good and poor responders 1-2 years after Gastric     Bypass surgery for obesity.   "
233278|NCT00908986|"     The objective of this study is to assess the as efficacy of rituximab as induction therapy in     membranous lupus nephritis. Safety and tolerability will additionally be assessed. Subjects     will receive open-label 2 courses of rituximab at baseline and at 6 months. They will be     followed monthly for 18 months to assess response and durability of response.      The hypothesis: B cell depletion will be an effective safe and well tolerated treatment for     membranous lupus nephritis (Class V).   "
233279|NCT00908999|"     This is a three year fMRI study conducted at the University of Wisconsin (UW) Hospital and     the William. S. Middleton VA Hospital. This study is guided by the hypothesis that reduced     fMRI activity and connectivity cortical midline structures (i.e., medial frontal and ventral     posterior cingulate cortex) are physiologic abnormalities that relate strongly to the     compromised insight into cognitive deficits, or anosognosia, shown by a subset of individuals     with amnestic MCI (aMCI) and AD. Further, the investigators hypothesize that these regional     changes in fMRI activity are predictive of faster progression from aMCI to AD.   "
233280|NCT00909012|"     Patients with phenylketonuria (PKU) have an inborn error in the metabolism of the amino acid     phenylalanine (Phe) and thus must follow a strictly controlled protein-restricted diet from     early infancy. This protein-restricted diet is devoid of natural dietary sources of n-3 long     chain polyunsaturated fatty acids (LC-PUFA), such as eggs, meat, milk or fish. Therefore,     blood concentrations of n-3 LC-PUFA, especially of docosahexaenoic acid (DHA) are reduced in     PKU children compared to healthy controls. DHA availability is considered important for     optimal neurological function. Previous studies have shown that neural function of PKU     children is improved by high dose supplementation of fish oil providing DHA, as shown by     significant improvements of both visual evoked potential latencies and of fine motor skills     and coordination, but no dose response relationship has been established so far.      This multicentric double-blind randomized trial aims at determining quantitative DHA     requirements for optimal neural function in PKU children. Patients with classical PKU from     several major treatment centers in Europe will be randomized to receive between 0 and 15 mg     of DHA per kg body weight daily for a duration of 6 months. Biochemical (fatty acid     composition of plasma phospholipids, lipoprotein metabolism and metabolic profiles), and     functional testing (visual evoked potentials, fine motor skills, cognitive function and     markers of immune function) will be performed at baseline and after 6 months. Intake per kg     body weight will be related to outcome parameters and thus a possible dose response     relationship will be defined. The results from this study are expected to contribute to the     improvement of the diet of PKU patients, but they also have the potential to help defining     quantitative DHA needs of healthy children.      The primary hypothesis is that supplementation with DHA improves visual function in children     with PKU.   "
233281|NCT00909025|"     Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal     adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill     cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular     cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of     this phase I study is to establish safety, toxicity and maximal tolerable dose of a single     infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and     gastric adenocarcinoma   "
233551|NCT00914381|"     To compare the efficacy of Community Reinforcement Approach (CRA) and 12-Step Facilitation     (TSF) counseling and of voucher based reward therapy (VBRT) and a yoked, non-contingent     voucher control (VC) for the treatment of cocaine dependent pregnant women or women with     young children.   "
233285|NCT00909077|"     In this study we want to investigate if combination therapy with rituximab (R) +     dexamethasone (DXM) is superior to monotherapy with DXM in patients with newly diagnosed     idiopathic thrombocytopenic purpura (ITP). Before treatment molecular studies - gene     expression profiling - are performed to characterize at the molecular level those patients     responding adequately to the treatment as compared to those obtaining a minor or no     responses.      The hypothesis is that combination therapy is superior to monotherapy as defined above. Using     gene expression studies up-front the hypothesis is that this method may be able to predict     the response to treatment.   "
233286|NCT00909090|"     The purpose of this study is:      I. To measure MP optical density (MPOD) spatial profiles in two groups (experimental and     placebo) of 50 subjects each (N = 100), during an L + Z supplementation period of 12 months.      II. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will     result in significantly improved visual performance under disability glare conditions.      III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will     result in significantly reduced photostress recovery times.      IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will     result in improved contrast enhancement.   "
233287|NCT00909103|"     The aim of the study is to assess elastography during EUS examinations of focal pancreatic     masses, and to consequently differentiate benign versus malignant pancreatic masses in a     prospective multi-center design.   "
233288|NCT00909116|"     Obstructed Defecation Syndrome (ODS) describes a condition which is characterized by chronic     constipation. The symptoms of ODS include abdominal pain or cramping, irregular bowel     frequency and the feeling of not having emptied the rectum. ODS is usually associated with     internal rectal prolapse and/or rectocele. For surgical treatment of ODS, a plethora of     surgical techniques have been described with no one method having been assessed as a gold     standard.   "
233289|NCT00909129|"     The purpose of this study is to investigate T-cell mediated immune responses to HIV-1 and HCV     and determine how these responses are affected by HCV treatment and correlates to response.     Furthermore, to study Interferon-inducible protein-10 (IP-10) dynamics during HCV treatment,     and correlate this to treatment outcome.   "
233290|NCT00909142|"     The effect of Bonefos on consumption of analgesics (drugs used for pain treatment) in     patients with proven bone metastases.   "
233291|NCT00909155|"     Do functional brain changes occur during Venlafaxine ER (extended release) versus Fluoxetine     treatment and do changes in selective structures, such as the amygdala, predict treatment     response?   "
233292|NCT00909168|"     This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for     treatment of newly diagnosed AML patients, younger than 66 years.      Trial is based on:        -  INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).        -  CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC          (HDAC)        -  INTENSIFICATION: Allo-BMT, ASCT        -  MAINTENANCE: AraC           a) Primary endpoints:        -  Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.        -  RFS, DFS and OS.           b) Secondary endpoints:        -  Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression          and monitoring.        -  Evaluation of prognostic clinical relevance of biological features at onset.        -  Feasibility and outcome of consolidation with BMT.   "
233293|NCT00909181|"     The primary objective of the double-blind phase of the study is to compare the effects of two     doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to     evaluate the extended safety and skin-irritation profile of topically administered oxybutynin     gel.      The hypothesis is that topically administered oxybutynin gel will decrease (compared to     placebo) the number of incontinence episodes per week, average daily urinary frequency, and     urinary urgency; increase average urinary void volume; and improve patient quality of life.   "
233294|NCT00909194|"     The purpose of this study was to identify clinical characteristics and estimate the     prevalence of Juvenile Primary Fibromyalgia in a female inpatient psychiatric population. The     secondary purpose of this study was to determine the efficacy of an intervention     (psychoeducational seminar and relaxation technique) on reducing the symptoms of Juvenile     Primary Fibromyalgia Syndrome. We looked at the short-term and long-term effects of this     intervention in comparison to the control (skin care seminar).   "
233295|NCT00909207|"     The scientific aim of this study is to evaluate patient comprehension of the 77 newly     developed items as well as the extent to which the items correspond to the concepts of     interest for each patient reported outcome (PRO).      A secondary aim of this study is to evaluate the usability of the technology interface for     collecting the PRO data of the PRO-CTCAE system once it has been built to accommodate the     learning garnered during the cognitive interviews.   "
233296|NCT00909220|"     This study will determine how people with depression differ from healthy people in brain     activity and interpreting emotions, both before and after receiving a psychotherapy     treatment.   "
233297|NCT00909233|"     This investigation targets either the patients of 18 years-old or older and under 65     years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient     efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg.     This investigation will be limited to the patients whose tolerability of Levitra 10mg is     judged to be no problem.   "
233312|NCT00909441|"     Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node     positive breast cancer.      Objectives of the study:      Primary objective      1. Evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with     positive nodal disease, proven by ultrasound guided fine needle aspiration, following     neoadjuvant chemotherapy.      Secondary objectives        1. Evaluate the technical success of sentinel node biopsy following neoadjuvant          chemotherapy.        2. Evaluate the accuracy of clinical examination and ultrasound examination of the axilla          in identifying the presence of residual disease in the axilla following neoadjuvant          chemotherapy in biopsy proven node positive breast cancer patients.      Number of patients:      N = 300      Population:      Patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that     present with biopsy proven positive axillary nodes.      Study duration:      From February 2009 to February 2012 - 3 years   "
233298|NCT00909259|"     The purpose of this feasibility study is to determine the effect of stimulating the phrenic     nerve to treat periodic breathing (a pattern of breathing characterized by hyperpneas     followed by hypopneas or apneas). Clinically, these physiologic events translate into sleep     fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly     ventricular arrhythmias.      Stage 1 of the study is acute in nature, such that subjects will undergo the placement of a     stimulation lead, followed by assessment of stimulation of the phrenic nerve using the lead     for up to 2 nights of sleep. A sensing lead may also be placed during the initial implant     procedure. Observational data will be obtained and stimulation provided using an externalized     system connected to the study leads. Following the study, all investigational components will     be removed from the patient.      Stage 2 of the study is being conducted at one of the participating sites to determine the     initial safety of chronic stimulation of the phrenic nerve in a limited number of patients     with sleep disordered breathing. It is anticipated that data obtained in this feasibility     study will show that the proposed intervention can modify respiration with a low incidence of     adverse effects. The results of this trial are intended to be used to develop a subsequent     protocol for a multi-center study of chronic phrenic nerve pacing.   "
233299|NCT00909272|"     Can an ultrasound machine be used to perform a diagnostic lumbar medial branch block?   "
233300|NCT00909285|"     Current diagnosis of Alzheimer disease is made by clinical, neuropsychological, and     neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific     features, such as atrophy, which is a late feature in the progression of the disease.     Therefore, developing new approaches for early and specific recognition of Alzheimer disease     at the prodromal stages is of crucial importance.      In the present study the investigators would like to examine if combined treatment with TMS     and cognitive training (CoTra) for several weeks can produce a sustained improvement in     cognitive and behavioral symptomatology of Alzheimer's disease (AD) patients. A number of in     vivo neuroimaging techniques, which can be used to reliably and noninvasively assess aspects     of neuroanatomy, chemistry, physiology, and pathology, hold promise.   "
233301|NCT00909298|"     The purpose of this study is to determine if post-operative administration of intrinsic     pathway antagonist (TTP889) in patients on Left Ventricular Assist Device (LVAD) support will     result in a 50% reduction of thrombin generation markers at 28 days compared to placebo.   "
233302|NCT00909311|"     The purpose of this study is to evaluate the effect of food on pharmacokinetics, safety and     tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in     healthy volunteers.   "
233303|NCT00909324|"     This study is designed to assess the tolerability and comfort of peri-operative 0.3%     hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3%     hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to     control (no pre-operative lubricant).   "
233321|NCT00909558|"     The purpose of this study is to assess the safety and effectiveness of natural killer (NK)     cell and natural killer T (NKT) cell-based autologous adoptive immunotherapy in subjects with     metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous     cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.   "
233322|NCT00909571|"     Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with     Tacrolimus based immunosuppressive regimens.   "
233304|NCT00909337|"     Exercise-induced increase of the pulmonary arterial pressure may be an early sign of     pulmonary arterial hypertension. It has been shown that patients with normal pulmonary     arterial pressure at rest but elevated pulmonary arterial pressure during exercise have a     decreased exercise-capacity and may have a worse prognosis compared to patients with normal     pulmonary arterial pressure values at rest and during exercise. According to the currently     used definition pulmonary hypertension can be diagnosed if the mean pulmonary arterial     pressure is higher than 25mmHg at rest or 30mmHg during exercise. In this study patients with     a risk for pulmonary arterial hypertension (connective tissue disease) and increased     pulmonary arterial pressure values during exercise are receiving a therapy with a dual     endothelin receptor antagonist - bosentan, a therapy established for pulmonary arterial     hypertension. The therapy effect is than compared to the recorded changes before the     introduction of this therapy.   "
233305|NCT00909350|"     This is a laboratory-based, exploratory study using tissue obtained from our clinical     practice. The purpose of this study is to confirm our ability to characterize miR expression     in various tissues (proximal and distal esophagus, stomach and duodenum) obtained from the     upper gastrointestinal tract in preparation for the study of MiR in patients with Barrett's     esophagus and other inflammatory conditions of the upper gastrointestinal tract.   "
233306|NCT00909363|"     The purpose of this project is to describe the pathophysiology of thrombocytopenia and     bleeding in patients with Wiskott-Aldrich Syndrome (WAS) and determine the response to     thrombopoietic agents in vitro and in vivo.   "
233307|NCT00909376|"     Many pregnant women have an ultrasound done of their fetus in the beginning of the second     trimester of pregnancy. Some have a transvaginal sonography while others have a     transabdominal one, depending on clinical parameters such as weight, scars etc. In the     transvaginal ultrasound there is some amount of version of the fetus done by the examiner to     maintain a better aspect of the fetus, while this is not done in a transabdominal sonography.      The objective of this trail is to determine whether having a transvaginal ultrasound as     opposed to a transabdominal one has an association to adverse perinatal outcomes.   "
233308|NCT00909389|"     This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe     + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.   "
233309|NCT00909402|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923     administered in combination with Cisplatin and Capecitabine as first-line therapy in subjects     with inoperable metastatic gastric, gastroesophageal or esophageal adenocarcinomas.   "
233310|NCT00909415|"     This study will examine the effects of spinal cord abnormalities on perioperative     neurovesical dysfunction in patients with anorectal abnormalities.   "
233311|NCT00909428|"     Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more     bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy     continues to surround the term 'urgency' and there is no good tool to evaluate the severity     of urgency. This fact has constrained the performance of clinical research in this field. The     cause of urinary urgency is not fully understood and may vary from patient to patient.      Although clinicians regularly obtain measures of bladder sensation during cystometry, little     attention has been paid to the patient experience of urinary urgency. In this study, the     researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary     urgency in women with overactive bladder.   "
233314|NCT00909467|"     Myelodysplastic and myeloproliferative Disease represent conditions with increased risk for     pulmonary hypertension. However, the exact prevalence of pulmonary hypertension in these     conditions is not known. The effects of pulmonary hypertension on the clinical picture and     the symptoms of patients in these conditions needs also further exploration. This exploratory     study is designed to describe the prevalence of pulmonary hypertension in the population with     such hematologic diseases, and the stages of pulmonary hypertension as well its effect on     exercise capacity at time of diagnosis.   "
233315|NCT00909480|"     This trial is conducted in Asia, South America and the United States of America (USA).      The aim of this clinical trial is to determine whether two insulin treatments given once     daily are equally effective with respect to the blood glucose lowering effect in subjects     with type 2 diabetes inadequately controlled on metformin treatment with or without an     additional anti-diabetic drug (OAD).   "
233316|NCT00909493|"     The proposed Nova Scotia Chronic Pain Collaborative Care Network (NSCPCCN) is a professional     development partnership between family physicians and chronic pain and addiction specialists     designed to build capacity in the health care system and provide improved pain management to     patients. The NSCPCCN will provide community physicians with access to chronic pain and     addiction specialists to assist in the management of patients with chronic pain. The current     project is designed as a pilot project to determine the feasibility of a this program on a     large scale. In order to determine the effect of implementation of a mentor- mentee network     in the primary care setting, a pilot project will be undertaken. The study will assess the     impact of the NSCPCCN on treatment of chronic pain and opiate management in two communities     in Nova Scotia prior to a proposed province wide rollout of the program.   "
233317|NCT00909506|"     The investigators hypothesize that adjuvant metformin use in breast cancer patients with     overweight or pre-diabetes mellitus (DM) may improve their body condition including weight     loss.      In this study, the investigators aim to test the efficacy and safety of adjuvant metformin     for operable breast cancer patients with overweight or pre-DM.   "
233318|NCT00909519|"     This phase 1 study is an 8-day treatment period, randomized, controlled, double-blind, 3     parallel-groups, monocentric study. The primary objective is to evaluate the effect of     naproxcinod on the renal function when co-administered with furosemide in comparison to     naproxen and placebo.   "
233319|NCT00909532|"     The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects     with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic     fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective     CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein.     Potentiators are pharmacological agents that increase the chloride ion transport properties     of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.   "
233324|NCT00909597|"     This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and     tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus     inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin     combination therapy. After an initial screening period, patients will be randomized to one of     3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4     weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of     pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target     sample size is 500+ individuals.   "
233325|NCT00909610|"     The objective of this study was to evaluate the comparative bioavailability between Ursodiol     500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference) after a single-dose in     healthy subjects under fasting conditions.   "
233326|NCT00909636|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     escalating multiple doses of the ABT-333 tablet formulation in healthy adult subjects.   "
233327|NCT00909649|"     This study was carried out from January 2005 to December 2007 at Mansoura university     hospital. Fifty patients who had breast cancer were included in the study, MRM was done for     all patients. Patients were randomly divided into two groups. Group І with fibrin glue 4ml of     fibrin glue was sprayed on the surgical area with Y canula and group П without fibrin glue.     Preoperative, Operative and Postoperative data were collected including postoperative     measurement of drainage, date of removal of the drain, state of the wound, incidence of     Seroma formation.   "
233328|NCT00909662|"     RATIONALE: Gathering information over time from women undergoing chemotherapy for breast     cancer may help doctors learn more about mental and physical fatigue caused by treatment.      PURPOSE: This clinical trial is studying fatigue caused by chemotherapy in women who have     undergone surgery for stage I, stage II, or stage III breast cancer and in healthy     volunteers.   "
233329|NCT00909688|"     To determine the safety, tolerability, and drug absorption profile of multiple IV doses of     BLI 489 in healthy subjects.   "
233345|NCT00909896|"     This study is being done to evaluate the efficacy of robotic approach for staging of     endometrial cancer as compared to an equivalent abdominal approach. The primary objective is     to measure and compare postoperative pain at rest at several time points between two groups     of patients undergoing either robotic or open laparotomy approach for staging of endometrial     cancer.   "
233912|NCT00919659|"     The purpose of this study is to determine whether the additional nutrition support is     improving the nutritional status of patients suffering cancer caxechia or not.   "
233330|NCT00909701|"     Surgical patients are usually starved for 8 to 12 hours before operation in order to reduce     the chances of vomiting and other complications during the anaesthetic. Recent studies have     suggested that this period of starvation might be harmful as it 'weakens' or 'stresses' the     body before the operation. To avoid these harmful effects of starvation, patients are now     given carbohydrate drinks (sugar-containing drinks that provide energy for the body) up to 2     hours before the operation. These drinks have been shown to make patients feel better, reduce     sickness after the anesthetic/surgery and result in quicker recovery from operation. But the     ways in which the sugar drinks have these beneficial effects on the body are unknown. The     optimum time of giving these drinks to patients before operation is also unknown. This study     will investigate the hormone responses of the body, following intake of 2 different     carbohydrate drinks, in order to determine the optimum time of intake of these drinks in     order to obtain the maximum benefits for the body.   "
233331|NCT00909714|"     Testing the hypothesis that non-invasive brain stimulation by transcranial direct current     stimulation (tDCS) combined with functional training in the subacute phase of first-ever     stroke will enhance functional regeneration compared with a Placebo intervention.   "
233332|NCT00909727|"     The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects     with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis     transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective     potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators     are pharmacological agents that increase the chloride ion transport properties of the channel     in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA)     activation.   "
233333|NCT00909740|"     This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A     administered by IV infusion to patients with advanced solid tumors for whom standard therapy     either does not exist or has proven to be ineffective or intolerable.   "
233334|NCT00909753|"     The objective of this study was to evaluate the comparative bioavailability between Ursodiol     500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference)after a single-dose in     healthy subjects under fed conditions.   "
233335|NCT00909766|"     The purpose of this study is to evaluate the safety, tolerability and effect on body weight     and other obesity-related factors of different doses of BMS-830216, compared to placebo. The     study will also determine the amount of BMS-830216 in the blood.   "
233336|NCT00909779|"     This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice     daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation     will consist of a total of 6 visits over approximately 1 year.   "
233337|NCT00909792|"     The objective of this trial is compare the visual performance, ratings, and preference of two     multifocal, soft contact lenses.   "
233360|NCT00901849|"     This study will evaluate the feasibility of combining two drugs, Tarceva (an anti-EGFR     agent), and Rapamycin (an mTOR inhibitor), in children with progressive low-grade gliomas who     have failed initial conventional treatment. In addition to evaluating the toxicity of this     drug regimen, the potential efficacy of the regimen will be assessed.   "
233361|NCT00901862|"     Background: The therapy with pulsed electromagnetic fields (PEFs) has been used as a     therapeutic modality for at least 40 years. However, their effect in the migraine prophylaxis     is unclear.      Objectives: Evaluate the prophylactic effectiveness of the therapy with PEFs in the handling     of migraines.      Methodology: Placebo-controlled, randomized, double-blind, crossed clinical study.   "
233362|NCT00901875|"     To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with     opiate dependence.   "
233338|NCT00909805|"     Inguinal incisions are the most frequent incisions used in children before the acquisition of     continence (180 incisions per year for the Pediatric Surgery Department in Nice CHU).     However, healing of those wounds can be made hard because of soiling induced by urine and/or     stool, which is unavoidable in case of wearing nappies.      Nowadays, in order to overcome a possible contamination of the surgical wound, post-surgery     wound dressing is protected by the application of a waterproof band aid (like Tegaderm®)     during wound-healing (evaluated to a mean of 7 days). When the band aid is soiled, a nurse     changes it, causing unpleasantness in low age children (whose epidermal fragility is well     known), and sometimes parents worry.      Moreover, those occlusive wound dressings avoid any control of the surgical wound during     healing phase.      At the end of the wound-healing time, wound dressings are removed, causing discomfort for     children and necessity of a qualified nurse staff at visit times.      Cutaneous use glues, introduced in surgery more than 10 years ago, allow making waterproof     and transparent sutures, with a firmness equivalent to a 2/0 string suture (cutaneous suture     in children is made with 5/0) and has its own local antiseptic properties. It does not need     to be covered by any wound dressing during wound-healing phase. Moreover, cosmetic results     for the 2-octyl-cyanoacrylate in the adult and children series (without any precise age     distinction) seem to be equivalent to conventional sutures. Finally, its application goes     with time saving (in preoperative and during wound-healing phase) and increases comfort for     patients.      The aim of this study is to evaluate the efficiency of cutaneous use glue Dermabond®     (2-octyl-cyanoacrylate) in surgical inguinal incisions sutures in children before the     acquisition of continence, by a non-inferiority randomized multicentric prospective study.      Two patient groups will be studied, the sutures of one control group will be made with a     conventional technique (intradermic surjet surgical suture), and one patient group will be     sutured with 2-octyl-cyanoacrylate. The principal evaluation criteria is the suture quality     (short- and long-term cosmetic aspect) evaluated by the surgeon.      Two secondary criteria will be studied :        -  Parental satisfaction        -  Ease of clinical nursing management Each studied criteria will be evaluated by a numeric          score.   "
233339|NCT00909818|"     The purpose of this study is to investigate the difference in late radiation morbidity     between hypofractionated and standard fractionated breast irradiation given to women operated     with breast conservation for early breast cancer.   "
233340|NCT00909831|"     RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving hydroxychloroquine together with temsirolimus may kill more     tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of hydroxychloroquine     when given together with temsirolimus in treating patients with metastatic solid tumors that     have not responded to treatment.   "
233341|NCT00909844|"     The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to     the proportion of children who maintain a regression or stabilisation of sexual maturity     until the end of the study.   "
233342|NCT00909857|"     To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on     alleviating complaints of dysmenorrhea associated with oral contraceptive use.   "
233343|NCT00909870|"     This study randomly assigns patients with venous leg ulcers to receive standard therapy     (compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live     human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they     heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for     three months in order to assess patients for longer term safety.   "
233344|NCT00909883|"     Foot dystonia is frequently observed in patients suffering from Parkinson'disease. It is     characterized by an abnormal involuntary movement which is very uncomfortable (difficult to     walk) and painful for the patient.      Botulinum toxin injections seem to be efficient to treat this dystonia. However studies on     this topic are few and very imprecise (many muscle injected, especially the Flexor digitorum     longus, different doses used, heterogeneous population with many types of dystonia included,     open studies).   "
233346|NCT00909909|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy in different ways may kill more tumor cells. Giving it after surgery may kill any     tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how     well it works in treating women with early stage breast cancer.   "
233347|NCT00909922|"     The aim of this study was to identify posture asymmetries in transfemoral amputees utilizing     clinical evaluation measures. The purposes of this investigation were: 1) to measure the limb     length indirectly to determine the proportion of participants with LLD and to quantify the     mean amount of discrepancy. The investigators hypothesized that a majority of transfemoral     amputees would present with a short prosthetic limb. 2) To measure pelvic tilt to determine     if transfemoral amputees undergo musculoskeletal adaptations similar to those reported in the     literature. The investigators hypothesized that transfemoral amputees would present with a     greater degree of anterior pelvic tilt and pelvic innominate asymmetry than what has been     previously reported. 3) To assess restriction in lateral trunk flexion and hip extension to     determine if asymmetry was present and if it was related to the increase in anterior pelvic     tilt. The investigators hypothesized that restrictions would be found in the lateral trunk     flexors and hip flexors on the amputated side contributing to posture asymmetry at the     pelvis. 4) To determine if musculoskeletal adaptations at the pelvis were affected by     prosthetic limb length, lateral trunk flexion and hip extension restrictions, and residual     limb length. The investigators hypothesized that the previously reported posture asymmetries     would contribute to musculoskeletal adaptations at the pelvis and trunk. Results of the     present study will provide a reference for clinicians when using clinical evaluation measures     to determine the presence of posture asymmetries in transfemoral amputees. If posture     asymmetries are detected, clinicians need to determine musculoskeletal structures at fault     and offer treatment solutions to prevent secondary impairments.   "
233348|NCT00909935|"     This study is designed to identify the plasma concentrations which are required to achieve     adequate sedation, using a Ramsay Sedation Scale. As an alpha 2 agonist, dexmedetomidine can     elicit hemodynamic changes, fluctuations in blood pressure and heart rate. This study will     attempt to determine whether these changes can be predicted by plasma concentrations.   "
233363|NCT00901888|"     The apelin-APJ system is a relatively new discovery. It has generated interest in part due to     it's apparent ability to counteract the renin-angiotensin system, which is frequently     overactive in many cardiovascular disease.      Angiotensin has a powerful ability to cause blood vessels constrict and reduces their     diameter. One of the actions of apelin is to cause blood vessels to relax and the     investigators specifically wish test the hypothesis that apelin will cause blood vessels     constricted by angiotensin II to relax.   "
233718|NCT00906646|"     This was a prospective randomised trial of metabolic therapy including antioxidants and     cellular energisers to determine whether this therapy could improve the results of cardiac     surgery. The hypothesis was that the metabolic therapy could improve clinical recovery.   "
233349|NCT00909948|"     The proposed study is based on our observation of paradoxical tumor regression after     rejection of the donor graft in conjunction with the results of our murine experiments. We     hypothesize that clinically meaningful responses can be achieved in patients with advanced     malignancies with a transplant strategy using nonmyeloablative conditioning and related     mismatched donor stem cell transplant where the intention will be to initially achieve mixed     chimerism which will be followed by recipient lymphocyte infusion (RLI) in an attempt to     deliberately reject the donor graft. This will lead to the development of novel transplant     strategies for achieving antitumor effects without the risk of graft versus host disease     (GVHD). This proposed protocol is a Pilot Study that will evaluate the safety of this     outpatient transplant strategy, i.e., establishment of initial mixed chimerism followed by     RLI for donor graft rejection, in patients with advanced lymphomas, and multiple myeloma.      In addition, because RLI have been reported to reverse ongoing GVHD, this approach might     potentially reverse GVHD while achieving antitumor responses if this complication     unexpectedly occurs.   "
233350|NCT00909961|"     This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical     markers of bone in post-menopausal osteoporotic patients aged between 50-65.   "
233351|NCT00909974|"     Low birth weight (LBW; birth weight<2,500g) is the most important determinant of mortality     and morbidity in the neonatal period. It is also a very important factor in predicting     nutritional status, health and development in childhood. It even influences health in adult     life, contributing to the vicious cycle of disease and poverty. The high rate LBW in DCs     represents therefore a major public health problem. Maternal chronic energy deficiency is     assumed to be a major determinant of the problem in these countries along with prenatal     micronutrient deficiencies. A large body of recent evidence points out that multiple     micronutrient supplementation as such has only a modest beneficial effect on fetal growth.     Therefore, it is expected that providing these multiple micronutrients in a food supplement     covering energy requirement needs of pregnant women will have an effect of public health     importance on children's health.      This study has the objective of improving children's health by improving birth outcome and     fetal growth through the provision of a food supplement enriched in multimicronutrients     during pregnancy.      This research includes 2 constituents:        1. a pilot phase during which dietary behavior of pregnant women is assessed as a component          for optimal fetal growth        2. a randomized, placebo-controlled trial, including 1300 pregnant women aimed at testing 2          hypotheses: supplementing pregnant women with a food supplement containing a          multivitamin-minerals mix will improve fetal growth; improved fetal growth will have a          positive effect on health and growth during infancy.      The trial is planned in Hounde District, Burkina Faso, in collaboration with Centre Muraz,     which plays a leader role in research and services providing at the district level and in     policy recommendations at the national level. This will ensure that the study findings are     incorporated into on-going district programs with possible replication at the national level.     The research lasts from February 2006 to August 2009.   "
233352|NCT00909987|"     Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy     (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with     CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic     Resonance Imaging.   "
233353|NCT00910000|"     This trial is a Phase Ib/II study of carboplatin/gemcitabine/vorinostat for the treatment of     platinum sensitive recurrent ovarian cancer. The carboplatin and gemcitabine combination is     an FDA approved regimen for platinum-sensitive recurrent ovarian cancer. Vorinostat is a type     of drug called a histone deacetylase inhibitor (HDAC inhibitor). HDAC inhibitors interact     with chromosomes in the cancer cell and cause cancer cells to stop growing. Vorinostat has     shown a decrease in the amount of ovarian cancer cells growing in the laboratory and also may     enhance the anti-cancer effects of carboplatin.The purpose of the Phase Ib study is to     determine the highest dose of the drug vorinostat that can be given safely in combination     with carboplatin and gemcitabine. Not everyone who participates in this research study will     receive the same dose of the study drug, vorinostat, but carboplatin and gemcitabine doses     are held constant. Vorinostat doses depend on previous enrollment and tolerability. The     expansion Phase II study uses the vorinostat dose found in the Phase Ib study in combination     with carboplatin/gemcitabine and as a single agent maintenance therapy to better understand     toxicity and efficacy.   "
233354|NCT00910013|"     Total knee replacement is a painful procedure. Many solutions have been proposed to diminish     the post-operative doses of narcotics, including nerve blocks.      The purpose of the study is to compare if the adjunction of intra-articular ropivacaine to a     femoral block is more effective on narcotics consumption than the block alone after TKR.   "
233355|NCT00910026|"     The aim of the present study is to evaluate the effect of low (6 ml/kg) and high (12 ml/kg)     tidal volume ventilation on inflammatory and oxidative stress biomarkers in the exhaled     breath condensate (EBC) of ICU patients without lung injury. As the analysis of EBC is     reflecting the composition of epithelial lining fluid (ELF), the study of EBC pH and     inflammatory and oxidative stress markers could have the potential for assessing lung     inflammation caused by mechanical ventilation. This study also aims to look at the     possibility to identify selective profiles of biomarkers that might have a prognostic and/or     diagnostic value in the follow up of these patients.   "
233356|NCT00910039|"     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib malate works after stereotactic     radiosurgery in treating patients with newly diagnosed brain metastases.   "
233357|NCT00910052|"     Background: Post-operative wound complications arise in as many as 50% of kidney transplant     recipients. Fibrin sealants have been used in many areas of surgery in attempt to reduce the     accumulation of post-operative fluid collections with varying success. The use of fibrin     products has been proposed as a means of reducing local wound complications in the     immunocompromised renal transplant recipient but as yet has not been studied.      Methods: 145 patients were enrolled and 141 patients were randomized (74 Tisseelä fibrin     sealant, 67 No Tisseelä fibrin sealant) in a prospective manner to receive fibrin sealant or     not at the time of their renal transplant. Patients were analyzed per the randomization     assignment. The operating team was blinded to the decision until after the iliac fossa     dissection was complete. The sealant was applied via aerosol to the iliac fossa and renal     allograft hilum after completion of the neoureterocystostomy in 5 ml quantity. Clinical and     radiographic data were reviewed through the usual 8-week follow-up transplant ultrasound.     Patients in whom the peritoneum was entered were excluded from data analysis. The incidence     of lymphocele, wound infection, dehiscence, clinically significant hematoma as defined by     necessitating incision and drainage, and urine leak was recorded.   "
233719|NCT00906659|"     The purpose of this study is to correlate changes of visual function three weeks after     photocoagulation for macular edema, with changes of center point thickness and macular     volume.   "
233364|NCT00901901|"     This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily     and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib     once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients     who are candidates for potentially curative intervention (i.e. surgical resection or local     ablation) are not eligible for this study.   "
233365|NCT00901914|"     The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1     administered as sublingual tablets in birch pollen allergic subjects.   "
233366|NCT00901927|"     The goal of this clinical research study is to learn if the combination of bendamustine     hydrochloride, mitoxantrone, and rituximab can help to control follicular lymphoma.      The safety of this drug combination will also be studied.   "
233367|NCT00901940|"     The purpose of the study is to evaluate and compare the immune response to two vaccines     against 4 related bacteria: meningococcal serogroups A, C, W−135 and Y. These bacteria can     cause meningitis and /or septicaemia (blood poisoning). The two vaccines are a     protein−polysaccharide conjugate vaccine (MenACWY)and a meningococcal plain polysaccharide     vaccine(MenACWY PS). Both vaccines are licensed and are currently used for travellers to     areas with a high incidence of invasive meningococcal disease. However, plain polysaccharide     vaccines are known to be poorly immunogenic in children and they do not stimulate     immunological memory, apart from the serogroup A component. In contrast, a     protein-polysaccharide conjugate vaccine against meningococcal serogroups A, C, W−135 and Y     has been found to be immunogenic in infants and to be able to induce immunological memory.      The proposed study is a single centre, open−label, randomised, controlled study in 150     healthy adults aged 18−70 years. The participants will be given either 2 injections of the     meningococcal protein−polysaccharide conjugate vaccine one month apart, or one injection of     the meningococcal plain polysaccharide vaccine followed one month later with an injection of     the meningococcal conjugate vaccine. Blood samples will be collected before immunisation and     at several time points following immunisations to evaluate the level of meningococcal     specific antibody induced by two different vaccination regimes. The data derived from the     study will be relevant in determining which of these vaccines should be used in preference in     travellers who are receiving immunisation against meningococcal disease before travelling to     high risk areas. Additionally, a number of scientific questions regarding the nature of the     immune response to the two vaccines (specifically looking at the white blood cells     responsible for producing antibodies, known as B cells) and the role of genetic variations in     influencing the vaccine recipient's immune response will be addressed in the study.   "
233368|NCT00901953|"     Do migrainous vertigo patients have more pathology in their vestibular system than migraine     patients without vertigo?      The aim of this study is to compare the vestibular system of migraine patients with and     without vertigo in the symptom-free period by vestibular function tests, videonystagmography,     vestibular evoked myogenic potentials, and subjective visual vertical.   "
233369|NCT00901966|"     This K07 Career Development Award application is designed to expand Dr. Dennis career     development from cancer etiology to cancer prevention and control. The career development     plan rests on mentoring directed by experts in cancer prevention research and protected time     to foster my professional development as an independent cancer control researcher. A unique     population, the Agricultural Health Study (AHS) cohort, will be used to examine sun exposure,     sun protection behavior, and factors affecting these behaviors regarding the risk of melanoma     in private pesticide applicators (farmers) and their spouses.      The research plan proposed to examine skin melanoma within this prospective cohort of private     applicators (mostly farmers) and their spouses in Iowa and North Carolina (the AHS) in     association with environmental factors. Specific aim 1 examined the risk of melanoma in the     AHS cohort using various existing measures of sun exposure adjusted for skin sensitivity and     sun protection. Subsequently (for aim 2) qualitative research methods were used to design     appropriate measures of sun exposure, sun protection behavior, and factors affecting these     behaviors in private applicators and their spouses within the AHS based on the cohort     analyses.      Now Aim 3 will be completed by conducting a nested case-control study of melanoma within the     AHS cohort to examine in more detail sun exposure histories and protective behavior. The     questionnaire was designed based on findings from the cohort analyses (aim 1) and qualitative     methods (aim 2). The risk of melanoma will be examined regarding: a) the complex relationship     of cumulative (sun exposure during each decade of life) and intermittent sun exposure     (sunburns and sunny vacations), b) factors affecting behavior including attitudes about sun     exposure and prevention, and c) the use of tanning salons and sunless tanning creams,     particularly in spouses (expected to be rare overall).      The final aim is to use the results from the cohort and nested case-control studies to design     a behavioral intervention, along with short computer automated telephone interview (CATI)     that can be used in the whole AHS cohort or other farming populations. Funding for such     studies will be sought through the R01) mechanism as an independent cancer control     researcher. The behavioral intervention will be based on those factors that are the strongest     risk factors for melanoma, highly prevalent, and easily modifiable. The behavioral     intervention will be designed based on knowledge and skill gained from the Career Development     Plan goals.   "
233370|NCT00901979|"     This study will assess the effect of LCQ when added to metformin.   "
233371|NCT00901992|"     A new diabetes education program for the initiation of intensive insulin therapy in type 2     diabetic patients (MEDIAS 2 ICT) was developed.      In the evaluation, this new developed program is compared with an education programs which is     currently used for diabetes education. It is expected that the new developed program (MEDIAS     2 ICT) can demonstrate non-inferiority with regard to the main outcome variable glycemic     control. If non-inferiority can be demonstrated superiority of this programs will be tested.      The results regarding the intervention arms MEDIAS ICT vs.  ACC (control condition) will     be separately analyzed and published.   "
233372|NCT00902005|"     The aim of this study is to examine the associations between inflammatory disease activity     and endothelial function in rheumatoid arthritis (RA) and spondyloarthritis patients treated     with methotrexate and Tumor Necrosis Factor alpha (TNFalpha)inhibitor in combination or     methotrexate or TNFalpha-inhibitor alone. Further, to look for improvement in endothelial     function, and decrease in bone and cartilage destruction during treatment with the     combination therapy of TNFalpha-inhibitor and methotrexate in RA and Psoriatic Arthritis     (PSA) patients. Last, examine the TNFalpha inhibitors influence on endothelial function and     levels of bone and cartilage markers in patients with Ankylosing Spondylitis (AS).   "
233373|NCT00902018|"     The purpose of this study is to further evaluate the effects that eltrombopag has on     platelets in subjects with chronic ITP. Eltrombopag is approved by the Food and Drug     Administration (FDA) for the treatment of low platelets in patients with chronic ITP. It is     being further studied by GlaxoSmithKline in other conditions associated with low platelets.     This research study is being done because eltrombopag has been shown to increase platelet     counts in a different way than other therapies for ITP. The investigators want to further     study how eltrombopag affects subjects and their platelets to determine how the study drug     should best be used in ITP treatment.   "
233374|NCT00902031|"     The purpose of this study is to determine if docusate is effective in the treatment of     constipation in palliative care patients.   "
233396|NCT00902330|"     RATIONALE: Cranial microcurrent electrical stimulation (CES) is mild electrical current     received through electrodes placed on the earlobes. CES may lessen symptoms in women with     breast cancer receiving chemotherapy. It is not yet known whether CES is more effective than     sham therapy in reducing symptoms caused by chemotherapy in women with breast cancer.      PURPOSE: This randomized phase III trial is studying mild electrical stimulation to see how     well it works compared with sham therapy in reducing symptoms caused by chemotherapy in women     with stage I, stage II, or stage IIIA breast cancer receiving chemotherapy.   "
233397|NCT00902343|"     The purpose of this study is to learn the best method of assigning patients to receive acute     normovolemic hemodilution during liver surgery.   "
233375|NCT00902044|"     Patients have a type of cancer called sarcoma. The sarcoma has come back after treatment.     Because there is no standard treatment for the patients cancer at this time or because the     currently used treatments do not work fully in all cases, patients are being asked to     volunteer to take part in a gene transfer research study using special immune cells.      The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancers. This research study combines two different ways of fighting disease:     antibodies and T cells. We hope that both will work better together. Antibodies are proteins     that protect the body from diseases caused by germs or toxic substances. They work by binding     those germs or substances, which stops them from growing or exerting their toxic effects. T     cells, also called T lymphocytes, are special infection-fighting blood cells that can kill     other cells, including tumor cells or cells that are infected with germs. Both antibodies and     T cells have been used to treat patients with cancers: they both have shown promise, but have     not been strong enough to cure most patients.      We have found from previous research that we can put a new gene into T cells that will make     them recognize cancer cells and kill them. We now want to see if we can put a new gene in     these cells that will let the T cells recognize and kill sarcoma cells. The new gene that we     will put in makes an antibody specific for HER2 (Human Epidermal Growth Factor Receptor 2)     that binds to sarcoma cells. In addition it contains CD28, which stimulated T cells and make     them last longer.      In other clinical studies using T cells, some investigators found that giving chemotherapy     before the T cell infusion can improve the amount of time the T cells stay in the body and     therefore the effect the T cells can have. Giving chemotherapy before a T cell infusion is     called lymphodepletion since the chemotherapy is specifically chosen to decrease the number     of lymphocytes in the body. Decreasing the number of patient's lymphocytes first should allow     the T cells we infuse to expand and stay longer in your body, and potentially kill cancer     cells more effectively.      We will use fludarabine or the combination of cyclophosphamide and fludarabine as the     chemotherapy agents for lymphodepletion. Cyclophosphamide and fludarabine are the     chemotherapy agents most commonly used for lymphodepletion in immunotherapy clinical trials.      The purpose of this study is to find the largest safe dose of chimeric T cells, to learn what     the side effects are, and to see whether this therapy might help patients with sarcoma.     Another purpose is to see if it is safe to give HER2-CD28 T cells after lymphodepleting     chemotherapy.   "
233376|NCT00902057|"     To study, with a prospective randomised controlled design, whether the subcutaneous     administration of the haemostatic drug desmopressin, may improve the impairment of primary     haemostasis due to mildly decreased temperature.   "
233377|NCT00902070|"     The main purpose of this investigation is to collect safety and efficacy information of Eslax     Intravenous 25mg/2.5mL and 50mg/5.0mL (hereinafter referred to as Eslax) in daily clinical     settings.   "
233378|NCT00902083|"     This is multicenter, open-label, randomized, active-controled, phase IV study of local direct     intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , or combination     with surgery for treatment of advanced oral and maxillofacial malignant tumors.   "
233379|NCT00902096|"     Background: Increased total serum IgE levels are a common characteristic of atopic diseases.     Increased cord blood IgE levels, in conjunction with a family history of atopy, are     associated with the development of allergic diseases in children. However, little is known     about predictors of cord blood IgE levels.      Objective: The aim of our study was to identify predictors of cord blood IgE levels in an     ongoing large birth cohort of infants with or without a family history of atopy.      Methods: Blood sampling of mothers was performed just before the delivery of newborns. Cord     blood was also collected when the child was born. Maternal and cord blood was measured for     IgE levels and cytokines. Questionnaires were administered after birth of the infant.   "
233380|NCT00902109|"     The purpose of this study is to compare the two psychophysical perimetric techniques     regarding progression of the visual field.   "
233383|NCT00902148|"     Study to investigate and determine the difference between the extent and severity of     intra-abdominal adhesions in patients where SurgiWrap film was placed compared to patients     with no adhesion barrier inserted.      Hypothesis: Due to the preclinical safety data and clinical case reports in various     indications it is anticipated that the surgical sites where the resorbable anti-adhesion     barrier SurgiWrap was placed, there will be a reduction of adhesions compared to the control     group with no treatment.   "
233384|NCT00902161|"     This study will assess the effect of combined treatment with MK0893 plus propranolol versus     placebo plus propranolol on hypoglycemia.   "
233385|NCT00902174|"     A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy     and safety of imatinib as an add-on therapy in the treatment of patients with severe     pulmonary arterial hypertension (PAH).   "
233386|NCT00902187|"     To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus     Zwickau.   "
233387|NCT00902200|"     Double-masked, randomized, multi-center, placebo-controlled parallel-comparison of AR-12286.   "
233388|NCT00902213|"     This will be the first multidisciplinary, randomized, longitudinal trial of a tailored,     parent- and child-focused physical activity program for children (ages 4- <19 years) with     newly diagnosed ALL. It will test the ability of the intervention to prevent or diminish     early physical function limitations and improve health-related quality of life (HRQL). The     intervention will be tested for its effect on: 1) physical function outcomes (muscle     strength, range of motion, endurance, gross motor skills), bone density and bone mineral     content (end of therapy only); and 2) HRQL. This multi-site trial will test the intervention     in 76 evaluable children with ALL (38 receiving the intervention and 38 receiving a placebo     minimal movement standard care strategy).   "
233389|NCT00902226|"     The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of     treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients     who respond to escitalopram during the treatment period, and to evaluate safety of     escitalopram.   "
233390|NCT00902252|"     The purpose of this clinical study is to demonstrate that the Vitala™ Continence Control     Device is both safe and effective when worn up to 12 hours per day.   "
233391|NCT00902265|"     Documentation of the efficacy and safety of desmopressin (Nocturin®) 0.1 mg tablet.     Observation of patients with benign prostate syndrome, in whom nocturia associated with     nocturnal polyuria is treated with desmopressin (Nocturin®) 0.1 mg tablet focusing on number     of nocturnal voids, ratio of night/24-h urine volume (%), duration of first undisturbed sleep     period and quality of life.   "
233392|NCT00902278|"     The goal of this research is to find out how the body's immune system responds to different     manufacturer's flu vaccines.   "
233393|NCT00902291|"     A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in     subjects with Metastatic Pancreatic Cancer.   "
233394|NCT00902304|"     This study will assess the efficacy of an intensive blood pressure management strategy     compared to usual care in a primary care (general practice) setting.   "
233395|NCT00902317|"     The purpose of this study is to compare the different endovascular treatment modalities for     the femoropopliteal segment, and to determine technical success, efficacy and patency at     mid-term follow-up. Modalities include; Angioplasty/stent (Control group, Guidant),     Cryoplasty/stent (Boston Scientific), Laser Angioplasty/stent (Spectranetics), SilverHawk     Atherectomy/stent (Fox Hollow), and Viabahn Endograft (WL Gore).   "
233401|NCT00902395|"     There is lack of clinical trials on pediatric dental sedation. The purpose of this study is     to test (using a randomized controlled trial design) the hypothesis that young children     behavior during dental treatment improves with oral midazolam sedation. A further aim of this     study was is explore whether behavior also changes over sessions needed to dental treatment     completion.   "
233402|NCT00902408|"     After a pilot trial where we showed an substantial increase in plasma lutein levels and a     increase in macular pigment optical density after only 3 months of daily consumption of a     lutein-enriched egg-beverage, we now propose to study the effect these changes have on     subjects with early ( undiagnosed) stages of macular degeneration. Age-related macula     degeneration, is the leading cause of blindness in many developed countries[1-6] in older     persons (usually over 55 years of age). Visual compromise rises exponentially after age of     70[7] with a 5-year incidence of around 1%. The incidence of bilateral AMD in persons with     unilateral late ARM observed over a period of 10 years of over 50% with a 2.1-2.8% overall     incidence in study population[8]. To date there is no curative way of fighting AMD. With the     results of this trial we hope to show that with daily consumption of these enriched beverage,     we can slow the progression of AMD. (Protocol page 8-10)   "
233588|NCT00914862|"     The purpose of this study is to determine the pharmacokinetic profile, safety, and     tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit     Hyperactivity Disorder (ADHD) associated with insomnia and gender- and race-matched healthy     adults.   "
233403|NCT00902421|"     The urologic literature suggests that there is an association between a variety of     psychiatric disorders and incontinence. Most notably, depression is found in a significant     percentage of patients with urinary incontinence. Depression also occurs in other conditions     associated with urinary urge incontinence, such as aging and dementia, and in neurologic     disorders such as normal pressure hydrocephalus. Correction of some neurologic disorders     eliminates both depression and urge incontinence. Although chronic medical disorders such as     urge incontinence may lead to depression, an alternative hypothesis is that these two     conditions share a common neurochemical pathogenesis. Lowering monoamines such as serotonin     and noradrenaline in the central nervous system (CNS) leads to depression and urinary     frequency and a hyperactive bladder in experimental animals. Thus, depression may not only be     the result of persistent urinary incontinence, but individuals with altered CNS monoamines     could manifest both depression and an overactive bladder. The latter condition may lead to     urge incontinence, urinary frequency, urgency, or enuresis. Uncovering further evidence for     such a linkage could serve as the basis for the development of genetic markers and novel     therapeutic interventions for these two conditions.      In this study, the investigators will evaluate the efficacy and safety of SSRI on OAB     patients who does not respond to the antimuscarinic agents.   "
233404|NCT00902434|"     This is an exploratory analysis that is investigating the pattern of care in patients over     the age of 80 who were diagnosed with non-Hodgkin lymphoma (NHL). This study will look at the     dose intensity and density implemented in this patient population to calculate whether     patients received the full course of therapy, received less duration of treatment, or     received lower doses of the drugs administered. Furthermore, the investigators would explore     time to disease progression for these patients regardless of the treatment received and     investigate whether patient outcomes differ based on the type of therapy or dose     intensity/density given.      This study is looking at retrospectively evaluating patients with NHL who are over the age of     80 at our institution between 2001-2007. It is anticipated that about 50 patients will be     included in this study.   "
233405|NCT00902447|"     The Human Blood Cell Disorder Tissue Bank will provide a convenient, comprehensive source of     tissue containing populations of human blood cells from patients with various types of     lymphoid, myeloid, and erythroid proliferative diseases as well as other associated     conditions. The tissue bank will continue to be an invaluable asset for understanding of the     biology of multiple blood cell disorders involving several cell types as well as the     physiology of normal cellular counterparts affected in these disorders. Internal and external     investigators will be able to utilize this tissue to test hypotheses relating to the     immunologic, virologic, genetic, and molecular properties of these abnormal cells as well as     normal cells from normal unaffected family members or normal aged matched subjects to provide     better comparisons.   "
233406|NCT00902460|"     CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is     designed to assess whether co-administration of CP-690,500 and midazolam will effect the     metabolism of midazolam in healthy volunteers.   "
233407|NCT00902473|"     The objective of this study was to compare the single-dose relative bioavailability of     Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg     dose under fed conditions.   "
233408|NCT00902486|"     This will be a randomized, double blind, placebo controlled, dose ranging, parallel group     study. Subjects with active rheumatoid arthritis (RA) who have had inadequate response to any     disease modifying anti-rheumatic drug (DMARD) therapy including biologics will be enrolled.     Screening evaluations will be performed within approximately 28 days of randomization. The     duration of the study is 6 months with the primary endpoint assessed at 3 months. Eligible     subjects will be randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 or     placebo.   "
233409|NCT00902499|"     The purpose of this study is to begin the process of validating fMRI (functional magnetic     resonance imaging) as a biomarker for use in clinical trials and longitudinal studies of     clinical progression in mild cognitive impairment (MCI) and Alzheimer's disease (AD).   "
233410|NCT00902512|"     the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with     and without water is similar relative to the conventional oral tablet of sildenafil     administered with water.   "
233411|NCT00902525|"     Despite of the availability of treatment for this disease, this study is justified because no     known therapies are really curative and it is necessary to look for new treatment options to     improve the clinical outcome and prognosis of relapsed aggressive lymphoma. This study is     designed for patients not eligible for high-dose chemotherapy and autologous stem cells     transplantation.   "
233690|NCT00906269|"     The purpose of this study is to determine if adding hyperbaric oxygen therapy, a therapy that     delivers oxygen under slight pressure, to a drug treatment of PDE5I (such as Viagra, Levitra,     Cialis)for men following surgery for prostate cancer will result in more men being able to     continue to have erections.   "
233412|NCT00902538|"     Both Olmesartan (OLM)/Amlodipine (AML) combination and Hydrochlorothiazide (HCTZ) have proven     to be efficacious and safe in lowering blood pressure, but may not always be sufficient. This     study is to test efficacy and safety of the combination of OLM/AML and HCTZ in hypertensive     patients whose blood pressure is not adequately controlled with OLM/AML alone. The following     treatments will be included in the trial: OLM 40mg/AML 10mg; OLM 40mg/AML 10 mg/HCTZ 12.5 mg;     OLM 40 mg/AML 10 mg/HCTZ 25 mg. The trial has four periods. The treatments that will be used     are as follows:      Period 1 - OLM 40mg/AML 10mg; Period 2 - OLM 40mg/AML 10mg or OLM 40mg/AML 10 mg/HCTZ 12.5 mg     or OLM 40 mg/AML 10 mg/HCTZ 25 mg; Period 3 - OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 -     Period 3 responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 non-responders: OLM     40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg   "
233413|NCT00902551|"     Very few screenings of any kind will be possible during a woman's lifetime in most     low-resource regions, where 80% of the half-million global cases of cervical cancer occur     every year. Although a single round of human papillomavirus (HPV) testing was associated with     a significant decline in the rate of advanced cervical cancers and associated deaths, whether     other methods like as DNA image cytometry can be used as an more accurate means than others     in screening cervical cancer or not is yet to be verified. In addition, the accuracy of both     DNA image cytometry and conventional cytology is not well known. The investigators     hypothesized that DNA image cytometry was superior in screening cervical cancer than     conventional cytology.   "
233414|NCT00902564|"     The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of     treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of     patients who respond to escitalopram during the treatment period, and to evaluate safety of     escitalopram.   "
233415|NCT00902577|"     This phase II trial is studying how well positron emission tomography (PET) scan using     18F-fluoromisonidazole works when given together with magnetic resonance imaging (MRI) ) in     assessing tumor hypoxia in patients with newly diagnosed glioblastoma multiforme (GBM).     Diagnostic procedures, such as MRI and PET scan using 18F-fluoromisonidazole (FMISO), may     help predict the response of the tumor to the treatment and allow doctors to plan better     treatment.   "
233416|NCT00902590|"     This study is being done to create a registry to help us learn more about urinary and other     cancers. This will let us look at large groups of people who do and do not have this kind of     cancer.      The investigators will look at risk factors to learn more about how these impact cancer. The     investigators will also look at genetic markers. These are genes that are found in a known     place. They are often associated with a particular trait. If the gene changes in some way, it     may predict cancer or response to treatment. The investigators will look for markers in your     saliva.      This registry will help us develop better methods of:      Preventing these cancers. Diagnosing these cancers. Treating these cancers.   "
233417|NCT00902603|"     The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that     longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been     receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I     PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2     years from the time of enrollment. Data will be collected via patient interview and review of     the medical record. Quarterly data collection will include capture of medications and     Ventavis® adherence data.   "
233418|NCT00910065|"     The objective of this study is to investigate whether intravenous administration (injected     into a vein) of acetylsalicylic acid (Aspirin) in doses of 250 and 500 mg is superior to oral     treatment of ACS with tablets containing 300 mg of Aspirin.   "
233419|NCT00910078|"     The purpose of this study is to evaluate the predictive role of free Kappa/Lambda ration in     Multiple Myeloma post-transplant.   "
233420|NCT00910091|"     This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA)     on progression free survival (PFS) in post menopausal patients with endometrial cancer.   "
233421|NCT00910104|"     The purpose of this study is to determine whether Omegaven is effective in the treatment of     parenteral nutrition associated liver disease (PNALD).   "
233422|NCT00910117|"     The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in     patients with locally advanced HNSCC. The hypothesis is that the response would be increased     with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.   "
233423|NCT00910130|"     The purpose of this study is to determine whether Retinol binding protein 4 has a role in     insulin resistance development in patients suffering from end stage renal disease on     hemodialysis.   "
233424|NCT00910143|"     Total mesorectal excision (TME) is a rather new operation technique in the treatment of     rectal cancer. It is known to reduce the rate of local recurrences. However, the influence on     long-term survival is unclear.   "
233425|NCT00910156|"     Comparison of ease and convenience of nasotracheal intubation with the use of the two     indirect laryngoscopes, Airtraq or Glidescope, versus the traditionally used Macintosh     laryngoscope.   "
233426|NCT00910169|"     The objective of this research is to evaluate the efficacy of five different in-patient     treatment modalities and predictive factors of outcome for anorexia nervosa. The primary     hypothesis is that the different treatment types impact outcome of patients at discharge from     inpatient treatment and at one year follow-up, even after adjustment for confounding factors     (age, length of illness, number of previous hospitalizations, clinical state at intake).   "
233427|NCT00910182|"     Retrospective study in order to investigate the outcome after conservative (with or without     transcatheter arterial embolization) and surgical treatment of splenic injuries.   "
233440|NCT00910351|"     Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate     antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation. This     planned study is the first study on the use of this new Ciprofloxacin PulmoSphere Inhalation     Powder in the pediatric population of 6 to 12 years of age.   "
233441|NCT00910364|"     The purpose of this pilot study is to assess the feasibility of determining the effects of a     structured exercise program started two to four weeks after diagnosis of a first episode     lower-extremity deep vein thrombosis (DVT) for a period of 12 weeks in reducing the incidence     of post-thrombotic syndrome (PTS).   "
233428|NCT00910195|"     Between 2%-4% of adult population suffers from obstructive sleep apnea (OSAS)(1), which is     characterized by obstructive snoring, repetitive apnea and hypopnea in sleep, repetitive     cyclic oxygen saturation, as a result from sleep fragmentation related to the arousals in     sleeping profile and clinical consequences like day drowsiness, neuropsychological deficits,     raised danger of accidents and cardiovascular disease. (1-6). The therapy of choice is the     application of nasal continuous positive airway pressure (CPAP) (7-9).      Increasing relevance obtain the combined sleep-related breathing disturbances, where the     patient shows an obstructive sleep apnea syndrome and some central breathing disturbances in     the polysomnography at night. Those patients frequently present with cardiovascular diseases.     These combined night breathing disturbances are frequently insufficient to be mitigated     exclusively with a CPAP therapy.      Some modifications of nCPAP therapy were developed in order to optimize the     therapy-compliance and the effectiveness of the therapy. Bi-level-CPAP-devices produce two     pressure levels: one for inspiration and another for expiration, so that the patients are     able expire against a constant low pressure. An increase in the use of this application in     comparison between the conventional or the automatic CPAP therapy could not be proved in     early studies. (12, 13) The principle of the automatic nCPAP therapy is to recognize the     patient's current need of pressure and to alter the pressure within a set range by applying     different algorithms. Some studies have shown that this therapy increased compliance and     comfort (14-16), while other studies could not confirm these results. (17, 18)      The result of the current study should prove if the treatment of a new algorithm therapy     based on an automatic bi-level-system for patients with sleep-related respiratory disorders     is as effectively and subjective more comfortable as the conventional CPAP therapy.      Patients with a particularly high need of pressure should experience a clear expiratory     pressure relief and a higher comfort. Therefore a better compliance is to expect. In the same     way patients with additional central respiratory disturbances should obtain a benefit from     the bi-level modus. This new treatment would help particularly such critical patients, who     are not responding well to the CPAP therapy or find it uncomfortable.   "
233429|NCT00910208|"     The aims of this study are to assess efficacy and safety of patient-controlled analgesia     (PCA) when applied to the Emergency Department setting and to compare the efficacy and safety     of two PCA dosing regimens.   "
233430|NCT00910221|"     Acute kidney dysfunction is common after cardiac surgery. While many patients suffer no     long-term ill effects from post-operative kidney dysfunction, some require initiation of     dialysis therapy that can contribute to long-term morbidity. Further, there is evidence to     suggest that those patients requiring dialysis after cardiac surgery have a higher risk of     death in hospital.      The exact reasons why some patients develop acute kidney dysfunction after cardiac surgery is     not well understood. However, research evidence to date has suggested that the presence of     co-morbid illnesses (i.e., diabetes mellitus) and exposure to cardiopulmonary bypass     (heart-lung machine used during operation when heart is stopped). Cardiopulmonary bypass, in     particular, has been shown to over-activate several aspect of the body's immune system. Such     over-activity can induce oxidative stress and contribute to acute kidney dysfunction.      The investigators believe that the statin drug, atorvastatin, might reduce the oxidative     stress that occurs during cardiopulmonary bypass, and thus, prevent or reduce the magnitude     of acute kidney dysfunction in those patients at highest risk. The investigators hope to give     atorvastatin (40 mg orally) to patients immediately prior to and for 3 days after cardiac     surgery, and to compare the effects on kidney function with patients who have not had     atorvastatin.      Atorvastatin is the most commonly prescribed medication in Australia and is used to reduce     blood cholesterol levels and decrease the risk of heart attacks and stroke. Recently,     however, it has been discovered that atorvastatin may be useful for prevention of     inflammation and oxidative stress in other conditions, such as following cardiac surgery with     cardiopulmonary bypass.      Thus, the investigators plan to examine whether atorvastatin can prevent acute kidney     dysfunction. This trial as planned is a pilot study. If atorvastatin shows promising evidence     of reduction in acute kidney dysfunction, further studies on a larger scale would be required     to justify its general use.      The investigators plan to determine whether atorvastatin, a statin drug, possesses kidney     protective effects in patients at risk for perioperative acute kidney dysfunction after     cardiac surgery and exposure to cardiopulmonary bypass.      This is a pilot, randomized, blinded, placebo-controlled trial.      The investigators plan to administer atorvastatin (40 mg orally) or placebo to patients     immediately prior to and for 3 days after cardiac surgery. The atorvastatin/placebo will be     given orally either by orogastric tube after induction of anaesthesia or swallowed by the     patients.      Whether a particular patient receives the atorvastatin or placebo will be decided at random,     and neither the patient nor the investigators will be aware of the allocated treatment.      The investigators plan to measure kidney function before and after cardiac surgery using the     standard blood tests. The investigators also plan to measure markers of inflammation and     oxidative stress in the blood. This may give insight into the mechanisms whereby atorvastatin     exerts its effects. The investigators will also take four 20 ml samples of blood, spaced     before, and after the operation, from the arterial catheter routinely inserted in every     patient undergoing cardiac surgery.      The investigators believe that there will be no significant additional risk to a patient who     participates in the study, and no discomfort other than that normally associated with cardiac     surgery. Informed consent will be obtained from the patient prior to the operation by one of     the investigators or the ICU research nurse. The clinical care of a patient who does not     consent for any reason will not be affected.   "
233448|NCT00913042|"     Febrile neutropenia are microbiologically documented in only 30% of the cases, and almost     exclusively by blood cultures. The reasons for this low documentation are likely multiple:     (1) some of these fevers are of non-infectious origin. (2) The bacterial inoculum present in     the blood may be low and consequently undetectable by conventional blood cultures.      The primary objective of the study is to assess new blood culture procedures and technics, in     order to improve the diagnostic yield of blood cultures during febrile neutropenic episodes.   "
233449|NCT00913055|"     To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) response of a hydrated and     non-hydrated 84 mg octreotide implant in patients with acromegaly in the first 6 weeks of     treatment.   "
233450|NCT00913068|"     The researchers propose to investigate a relatively new anesthetic procedure, in order to     maximize patient comfort and minimize the use of narcotics after a radical prostatectomy.   "
233431|NCT00910234|"     Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in     preterm infants. Inflammation, hypoxia-ischemia, free oxygen radical formation and     excitotoxicity are all known pathogenic mechanisms that mediate this injury. Erythropoietin     (EPO) has been shown to be protective against hypoxic-ischemic and inflammatory injuries.     During the past decade, recombinant human Epo (rhEpo) has been widely used in preterm infants     to prevent or treat the anemia of prematurity, in general, rhEpo has been considered to be     safe and well tolerated in preterm infants. EPO was considered not capable of passing through     blood-brain-barrier at low dose. Evidence from animal experiments reveals that rhEpo must be     given in high doses at the beginning or within a short (up to 6 hours), critical time period     after the onset of brain injury to achieve a significant neuroprotective effect. A recent     study using high-dose rhEpo (3000 U rhEpo/kg body weight at birth) for neuroprotection in     very preterm infants revealed that no signs of adverse effects of early high-dose rhEpo     treatment in very preterm infants were identified. Contrary to this, a recent study in PVL of     a rat model revealed that using a low dose rhEpo (50-100 U/kg) was effective in the treatment     of brain damage induced by hypoxia-ischemia and did not affect normal oligodendrocyte     maturity. On this basis, the researchers intent to investigate (1) whether low-dose rhEpo     (100 U/kg) or high-dose rhEpo (3,000 U/kg) given to very preterm infants (gestation age < 32     weeks) immediately after birth and subsequently during the first 2 days is safe and possesses     neuroprotective properties;(2) whether there are gender differences in response to the     hypoxia-ischemic insult and EPO treatment; (3)the pharmacokinetics of low dose and high dose     rhEPO. Very preterm infants with gestational age of < 32 weeks and admitted to the NICU are     eligible for enrollment.   "
233432|NCT00910247|"     This is a long term, open-label, safety extension study in subjects with partial onset     seizures.   "
233433|NCT00910260|"     We plan to investigate the serum elevation of 25(OH)D under UVB nb and UVA1 therapy, in order     to determine the effect of these nowadays frequently used wavelengths for phototherapy on     vitamin D plasma levels. We hope for a better understanding of steady-state and     treatment-induced levels of vitamin D changes to better recognize the impact of phototherapy     on vitamin D synthesis in the skin, the dimension of vitamin D production to be expected in     the course of standard phototherapy and a potential gap in vitamin D production compared to     physiological needs which then should be supplemented orally.   "
233434|NCT00910273|"     Study to assess whether etanercept therapy is able to increase flow-mediated vasodilatation     in AS, and whether etanercept can modify the intima-media thickness (IMT) in these patients   "
233435|NCT00910286|"     Objective: To compare termination criteria (TC) of pressure support ventilation (PSV).      Design: Randomized cross-over clinical trial.      Setting: Intensive Care Units.      Patients: Sixteen patients on PSV with ability to answer a visual analog scale (VAS).      Protocol and Measurements: Each patient was ventilated with two different TC ventilators,     fixed and automatic, with measurements of ventilatory mechanic variables, breathing comfort     and asynchrony patterns.   "
233436|NCT00910299|"     To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse     cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after     successful implantation of coronary drug-eluting stents.      To determine the adverse event profile of prasugrel in patients with high platelet reactivity     on clopidogrel after implantation of coronary drug-eluting stents.      To determine the effect of prasugrel on inhibition of platelet activation in patients with     high platelet reactivity on clopidogrel.   "
233437|NCT00910312|"     The purpose of this study is to determine whether the Ice-Sense, a novel cryotherapy system     (a system that freezes tissues), is safe and effective in the treatment of benign breast     tumors such as fibroadenoma.   "
233438|NCT00910325|"     To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to     cholecystectomy and to establish a description of this novel translumenal technique in humans     at this institution.   "
233439|NCT00910338|"     Stress urinary incontinence is the most common type of female incontinence. The efficacy of     pelvic floor muscle training with biofeedback has been already proved in many studies. But     intravaginal probe is one of the limitation. So, the purpose of this study is to assess the     efficacy and safety of extracorporeal biofeedback device with pelvic floor muscle training.   "
233464|NCT00913250|"     Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of     Avonex.   "
233442|NCT00910377|"     The purpose of this study is to determine whether counseling sessions on breastfeeding for     adolescent mothers and their grandmothers in the maternity ward and at home are effective in     to improve the exclusive and total breastfeeding rates during the first six month, as well as     the convenient timing of supplementary feeding introduction.   "
233443|NCT00910390|"     This randomized study compares three different freezing methods to store human in vitro     fertilization (IVF) embryos: vitrification with two commercial kits or slow freezing. After     information, all patients undergoing IVF treatment can be included in the study. If     qualified, embryos at different developmental stages will be allocated between the three     methods. At the end of the first year survival and developmental rates, and implantation and     pregnancy rates will be analyzed in order to determine the best method.   "
233444|NCT00912990|"     The investigators' primary specific aims are to demonstrate that:        1. Pediatric patients with normal airways, undergoing elective surgical procedures, can be          successfully intubated when deeply sedated, without the use of muscle relaxants using          the Shikani Optical Stylet.        2. Shikani intubation of pediatric patients is equally effective in children that are          deeply sedated or paralyzed as evidenced by a non-significant difference in:             -  Time to intubation (defined as no more than a 30 second time difference between the               two groups);             -  Incidence of adverse events.   "
233445|NCT00913003|"     The aim of this study is to determine if perioperative systemic lidocaine administration will     decrease the amount of opioid analgesics required in women undergoing mastectomy surgery. In     addition, patients receiving systemic lidocaine will have a lower incidence of     post-mastectomy pain syndrome.      This study will have 2 groups. Participants will be randomized into one of each group. The     first group will be administered the drug lidocaine prior to surgery and the second group     Group B will be administered saline (salt water). This is a blinded study which means the     participant will not know which group they have been assigned. The subjects participation     will last 12 months (surveys post operatively).   "
233451|NCT00913081|"     Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective     drug to raise HDL, or the good cholesterol. The use of niacin has been limited because of a     peculiar adverse effect referred to as flushing', which consists of redness, warmth,     tingling and burning. A recent animal study suggests that flavonoids may prevent flushing due     to niacin better than drugs like aspirin. The ANTI-FLUSH study is being done to assess     whether a presently available dietary supplement known as quercetin, which is a flavonoid,     can reduce the flushing that occurs with niacin. We will also assess whether using quercetin     to prevent flushing from niacin, can improve how niacin lowers cholesterol.   "
233452|NCT00913094|"     To determine whether impedance cardiography (ICG) parameters can predict favorable or     unfavorable blood pressure (BP) response and time to BP control prior to initiation or     intensification of specific antihypertensive drug classes and drug combinations, independent     of initial BP levels.   "
233453|NCT00913107|"     The purpose of this study was to determine the efficacy and safety of lamotrigine in patients     with trigeminal neuralgia (TGN).   "
233454|NCT00913120|"     The purpose of this study is to examine the superiority of YM150 to the placebo and to     evaluate the dose-dependent response of YM150 in patients undergoing elective total hip     replacement surgery.   "
233455|NCT00913133|"     The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin     for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.   "
233456|NCT00913146|"     The investigators performed a prospective study, in order to assess the feasibility and     safety of restricting antimalarials to rapid diagnostic test (RDT)-confirmed cases in     children aged 5 to 15 years-old   "
233457|NCT00913159|"     The older lithotripter, HM3, has over 90% stone-free rate in most studies. However, it's less     transportable than the new model, F2. There are no prospective trials performed to make a     valid comparison between these 2 lithotripters in terms of efficacy of stone fragmentation     and clinical outcomes.   "
233458|NCT00913172|"     Evidences for policy making and decision related to the cost of delivering tuberculosis (TB)     control is lacking in Ethiopia. The investigators aimed to determine the cost and     cost-effectiveness of involving health extension workers (HEWs) in TB treatment under the     community-based initiative in Ethiopia.   "
233459|NCT00913185|"     The purpose of this study is to compare the effectiveness of two over the counter acne     products in subjects with moderate severity acne vulgaris. The two products being compared in     this study are Acne Free Severe Acne Line manufactured by University Medical Products, and     Proactiv® manufactured by Guthy-Renker.   "
233460|NCT00913198|"     The main objective of this study is to assess the biological activity of CP-4126 in patients     with advanced pancreatic cancer. In addition, the correlation between hENT1 (human     equilibrative nucleoside transporter 1) and overall survival will be studied.   "
233461|NCT00913211|"     Paralysis following stroke stems not only from the loss of neurons killed by the stroke but     also from the loss of neurons lying dormant in the stroke hemisphere. One of the reasons     viable neurons become dormant (down-regulated) is because of excessive interhemispheric     inhibition imposed on them from the nonstroke hemisphere. The challenge in     neurorehabilitation is to restore excitability and voluntary control of these down-regulated     neurons in the stroke hemisphere. Suppression of the source of this excessive     interhemispheric inhibition can be achieved with the noninvasive method called repetitive     transcranial magnetic stimulation (rTMS). It has been shown in healthy subjects that the     known depressant effects of low-frequency rTMS can be increased and prolonged by preceding it     with 6-Hz priming stimulation. In a recent safety study, we showed that one treatment of 6-Hz     primed low-frequency rTMS applied to the nonstroke hemisphere is safe. It is now important to     evaluate a series of these treatments and whether their efficacy can be enhanced by combining     the rTMS with motor learning training. The specific aims of this study are to determine the     efficacy, mechanism, and safety of a series of 5 treatments of 6-Hz primed low-frequency rTMS     applied to nonstroke hemisphere and combined with motor learning training to promote recovery     of the paretic hand. Forty subjects with stroke will be randomly assigned to one of four     treatment groups. The rTMS/only group will receive 20 min. of rTMS per day. The Track/only     group will receive 20 min. of finger tracking training per day. The rTMS/combined group will     receive alternating days of the rTMS and Track treatments. The rTMS/sham group will receive     20 min. of rTMS using a sham electrode each day. The hypotheses are: 1) the rTMS/combined     group will show the greatest improvements in hand function, 2) the rTMS/combined group will     show the greatest improvements in cortical excitability using paired-pulse TMS testing and in     brain reorganization using fMRI, and 3) the rTMS treatment will be safe. The proposed     research is important because it addresses the greatest cause of long-term disability in     society, hemiparesis following stroke, and it is innovative because it applies a technique     never used before, 6-Hz primed low-frequency rTMS combined with motor learning training. The     potential impact of this research is a radical change to rehabilitation that accomplishes a     higher quality of life in stroke.   "
233462|NCT00913224|"     To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated     tablets.   "
233463|NCT00913237|"     To demonstrate the relative bioavailability of Desipramine Hydrochloride 50 mg tablets.   "
233465|NCT00913263|"     The primary objective was to evaluate efficacy of a single dose of Liproca Depot in patients     with localized prostate cancer. Primary efficacy variable was the proportion of patients     showing PSA nadir. 24 Caucasian men, with a mean age at inclusion of 68.4 years, with     localized prostate cancer were injected once with a ready made paste including 600 mg     2-hydroxyflutamide (Liproca Depot) into the site of the prostate where the tumour was     localized. The patient was monitored for prostate-specific antigen (PSA) for maximum 6 months     or to progression within this time period. The primary endpoint showed interesting results     with high success rate (83%), i.e. proportion of patients (Responders) that reached plasma     PSA nadir.   "
233466|NCT00913276|"     The gap between the number of candidates for orthotopic liver transplantation and the     availability of suitable liver grafts has led to a rise in deaths on most waiting lists.     Strategies applied in many centers to minimize this deficit include living donation or split     of a cadaveric organ for two recipients, domino transplantation, and the use of so-called     expanded criteria donors. Alternatively, conditioning of an organ would also allow     protec-tion of the liver upon ischemia-reperfusion injury, possibly decreasing postoperative     liver function and im-proving clinical outcome. The technique of conditioning with the     volatile anesthetic sevoflurane is an easily applicable procedure which could be performed in     any center worldwide.      Data and experience with sevoflurane attenuating ischemic-reperfusion injury in liver     resection lead to the hypothesis of a beneficial effect of volatile anesthetics in liver     transplantation. In this randomized controlled trial, patients will be randomly assigned to     liver transplantation with propofol anesthesia (propofol group) or sevoflurane conditioning     with the volatile anesthetic (sevoflurane group). Primary endpoint is postoperative peak of     the transaminase (AST), secondary endpoints are complications, primary liver graft function,     ICU and hospital stay. We hypothesis that patients with conditioning have an attenuated     increase of transaminases as well as a better outcome.   "
233467|NCT00913289|"     Mesenchymal stem cells have the capability to differentiate into hepatocytes and will be     useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem     cells compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will     receive autologous adipose tissue derived stromal cells which include such mesenchymal stem     cells.   "
233468|NCT00913302|"     To test the effects of a cardiovascular training compared to attention control in a group of     AS-patients participating in classic spinal mobility exercise groups (randomized controlled     trial)   "
233469|NCT00913315|"     The purpose of this study is to determine whether tamsulosin and tolterodine are effective in     the treatment of men with lower urinary tract symptoms and chronic prostatitis/chronic pelvic     pain syndrome.   "
233470|NCT00913328|"     Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the     effect of inhaled corticosteroids.      Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled     methacholine in patients with mild to moderate persistent asthma treated with a stable dose     of inhaled corticosteroids.   "
233471|NCT00913341|"     To demonstrate the relative bioavailability of Alprazolam tablets, 1 mg.   "
233472|NCT00913354|"     During IVF treatment, acupuncture at the time of embryo transfer may improve the pregnancy     rate. This study aims to compare IVF pregnancy between two groups of patients that received     either acupuncture or sham acupuncture (placebo)around embryo transfer   "
233473|NCT00913367|"     The purpose of this study is to compare the efficacy of Amaryl®M 1/500 mg twice daily versus     Amaryl® 4 mg both in combination with Lantus® once-daily regimen in type 2 Diabetes Mellitus     patients with inadequate glycemic control.   "
233474|NCT00913380|"     The purpose of this study is to determine whether low-dose CT is not inferior to     standard-dose CT in the rate of unnecessary appendectomy.   "
233475|NCT00913393|"     The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or     diabetic nephropathy.   "
233476|NCT00913406|"     Study to determine if the addition of lutein to infant formula supports healthy growth and     development in healthy full term infants.   "
233477|NCT00913419|"     To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.   "
233478|NCT00913432|"     A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib     at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active     rheumatoid arthritis refractory to standard treatments.   "
233479|NCT00913445|"     The purpose of this trial is to compare two techniques of wound closure in open     appendicectomies in adult patients: continuous, absorbable, intradermal suture and     interrupted, non-absorbable sutures.   "
233480|NCT00913458|"     Study to evaluate whether there is sustained remission and productivity in subjects with     early rheumatoid arthritis started on etanercept plus methotrexate treatment.   "
233481|NCT00913471|"     The investigators propose to compare plasma protein profiles for SCI patients with/without     chronic neuropathic pain in order identify biomarker(s) that are associated with this medical     condition. Secondly, the investigators propose to identify a temporal relationship to initial     SCI at which these biomarkers manifest.      Our working hypothesis is that sustained alterations in specific inflammatory molecules are     associated with chronic neuropathic pain following SCI, and that their plasma levels can     serve as biomarkers to identify patients at risk for the development of neuropathic pain.      Additionally the investigators are collecting skin tissue biopsy samples from patients     following acute and chronic spinal cord injury to create vector-free human iPS cells from     fibroblasts by direct delivery of reprogramming proteins.   "
233482|NCT00913484|"     The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy     and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse     in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on     buprenorphine/naloxone combination.   "
233483|NCT00913497|"     To determine whether insulin glulisine decreases the breakfast post prandial glycemic     excursion in comparison to insulin aspart.   "
233561|NCT00914511|"     The purposes of this study are to:        -  Determine the effect of the study drug on sperm and semen of healthy young male          subjects.        -  Determine the effect of age on the amount of study drug in the blood of healthy subjects        -  Learn about the safety of the study drug.        -  Learn how subjects tolerate the study drug.   "
233484|NCT00913510|"     The aims of this prospective, randomized study are:        -  To assess the effect of clean intermittent catheterization (CIC)        -  To investigate if MS patients will have symptom reduction (urgency, frequency, nocturia          and incontinence) when using CIC in combination with anticholinergic drugs        -  To identify at what volume of Postvoid Residual (PVR) urine, starting CIC improves          bladder control and QoL        -  To increase the evidence of CIC, and support clinical guidelines of bladder management          in MS patients   "
233485|NCT00913523|"     Subjects will be using investigational or control tampons during their menstrual period but     these tampons are not intended to prevent, treat or diagnose an infection or other disease     condition. A total 450 women will participate in this study at two study sites. Subjects will     be randomly assigned to one of three tampon groups. The first group will test an experimental     test tampon containing glycerol monolaurate (GML) on the cover. The second group will test an     identical tampon, but without GML. The third group will not be issued study tampons but will     be instructed to use their normal tampon brand. This study is intended to determine whether     the effects of GML observed in the laboratory can be demonstrated in healthy menstruating     women.   "
233486|NCT00913536|"     This study is designed to investigate whether daily images of the pelvis and bladder using a     device called a cone beam CT scanner will help to increase the accuracy of radiotherapy     treatment. The cone beam CT scanner is a part of the radiotherapy treatment unit. The results     of the study may allow patients in the future who are undergoing radiotherapy treatment for     bladder cancer to 1) have more accurately directed treatment, 2) have higher doses of     radiation delivered to the tumour while keeping doses to the surrounding normal tissues as     low as possible. This may allow eradication of the cancer while minimizing side effects of     treatment.      This study consists of two phases: Phase A and Phase B. In Phase A, images were collected and     analyzed and it was confirmed that it was useful to use the cone beam machine for daily Cone     Beam CT Bladder (Phase B)treatment adjustments. In phase B, we hope to be able to use cone     beam CT scans to more accurately direct the radiotherapy treatments on a daily basis.   "
233487|NCT00913549|"     To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 mg     tablets.   "
233488|NCT00913562|"     Endothelial dysfunction can be seen in a variety of vascular related ocular diseases such as     glaucoma or diabetic retinopathy. There is accumulating evidence now that statins may at     least partially improve endothelial function in several vascular beds, an effect that is     probably independent of the lipid lowering effects of the statins.      Consequently, the current study seeks to investigate whether administration of 10 mg     rosuvastatin by mouth (p.o.) for 12 weeks can improve the endothelial function in patients     with glaucoma and diabetic retinopathy. For this purpose, flow mediated vasodilatation of the     brachial artery and flicker induced vasodilatation of retinal vessels will be measured at     baseline, after 6 and 12 weeks of treatment with rosuvastatin.   "
233489|NCT00913575|"     Background:      Osteoarthritis (OA) is a common degenerative condition of large weight-bearing joints, such     as the hip and knee, as well as small hand joints. Current interventions in patients with OA     are limited to symptomatic pain relief and later with total joint replacement (TJR). While     TJR improves function and pain, it does not fully restore function in most individuals. A key     factor of functional outcome is probably conditioning before and after TJR surgery. However,     this has not been studied conclusively in patients undergoing TKR surgery.      Objective:        1. Primary endpoint: To study the effect of a pre-surgery neuromuscular PT compared to an          attention control program on lower extremity function measured by the Chair stands test          (observed function) and the KOOS score (reported function).        2. Secondary endpoints will be muscle strength, walking time and mobility.      Hypothesis:      The investigators hypothesize that patients undergoing pre-surgery PT will be significantly     quicker in performing the chair stands test and report a significant improvement in the KOOS     at 3 months after surgery compared to controls.      Methods:      80 patients from a waiting list for unilateral TKR will be randomized to neuromuscular PT or     an attention control group intervention in a single-blinded randomized controlled trial.     Assessments will be at baseline, at 3 months after surgery and at 12 months after surgery.      Intervention:      The neuromuscular PT group will receive a minimum of 8 and a maximum of 24 training sessions;     all patients, including the control group, will receive 4 sessions of the Knee School.      Significance:      Given the demographic change with an increase in the older segment of the population there     will be a rise in the absolute number of TKRs. It is therefore warranted to study pre-surgery     neuromuscular PT to help patients get the most out of their joint replacement.   "
233490|NCT00913588|"     To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine     Hydrochloride capsules (Pulvules) in healthy adult males under fed and fasted conditions.   "
233491|NCT00913601|"     Faecal incontinence is a devastating condition causing psychological stress, affecting daily     living and influences quality of life. Faecal incontinence affects 2,2 to 5 % of the adult     population. The magnitude of the problem is probably underestimated, because most patients     don't discuss this affliction with their general practitioner. A new treatment, sacral nerve     stimulation (SNS), has over the last decade given hope to these patients. The treatment is     divided in two; first a test operation (PNE-test) has to reveal if the patient will benefit     from treatment with permanent sacral nerve stimulation. Second if the patient benefit from     the PNE-test, they proceed to final implant. 75-80% of the patients with idiopathic fecal     incontinence benefit from the PNE-test, 70% of those get satisfactory functional results and     the remaining 30% get suboptimal improvement in continence after permanent unilateral sacral     nerve stimulation. The aim of this project is to investigate if bilateral sacral nerve     stimulation can produce better fecal continence results than standard unilateral stimulation,     through a double blind, randomized crossover study.   "
233492|NCT00913614|"     Given the potential age-related differences in safety, tolerability, pharmacokinetics, and     differences in sleep architecture in young children versus adolescent versus adult, studies     to identify the appropriate drug and dosage for children of all ages are essential in     addressing this health problem that impacts the child and their family. The objective of this     study is to evaluate the safety, pharmacokinetics and preliminary efficacy of eplivanserin.      Primary objective: to assess the safety and tolerability after administration of single     ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various     origins.      To assess the pharmacokinetics of eplivanserin (and active metabolite: SR141342) after     administration of single ascending oral doses of eplivanserin to children aged 6-17 years     with insomnia of various origins.      Secondary objective: to assess the effect of single ascending oral doses of eplivanserin on     global sleep parameters and sleep architecture measured via polysomnography recordings in     children aged 6-17 years old with insomnia of various origins.   "
233575|NCT00914693|"     The aim of the present study is to prove efficacy and safety of a new contraceptive patch.   "
233493|NCT00913627|"     The purpose of this study is to assess the efficacy and safety of a single dose of an     ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern     that the manufacturing process may affect the performance characteristics of the selected     prototype. Therefore, two formulations of this prototype manufactured by two different     processes, [roller compaction] and [wet granulation] will be included in this study. The     preferred prototype manufactured by two different methods will be compared to placebo and     each other. This study will also characterize the pharmacokinetic/pharmacodynamic     relationship with these formulations.   "
233494|NCT00913640|"     The investigators tested whether prospective memory is impaired in individuals with     Parkinson's Disease compared to controls using reliable and validated experimental measures.     Also, the investigators assessed the impact of Parkinson's medication on prospective memory     performance in PD to better estimate prospective memory function in PD patients' everyday     (chronically treated) life.   "
233495|NCT00913653|"     This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart     failure.   "
233496|NCT00913666|"     This study will look at differences in bioanalytical measures among different groups of MS     patients and Healthy Volunteers, when administered interferon beta-1a.   "
233497|NCT00913679|"     The purpose of the study is to compare two different surgical techniques in hip resurfacing     arthroplasty (RHA), comparing bloodflow and metabolism in the femoral head, as well as     implant migration, periprosthetic bone mineral density, gait function and patient recovery.   "
233511|NCT00913861|"     The purpose of this study is to determine whether a non-pharmacological intervention reduces     consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce     side effects. This non-pharmacological intervention may increase patient's comfort and     security.   "
233512|NCT00913874|"     To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release     tablets under fasting conditions.   "
233513|NCT00913887|"     To demonstrate the relative bioavailability of Diclofenac Sodium 75 mg enteric-coated tablets     under non-fasting conditions.   "
233589|NCT00914875|"     double blind study of kidney function of two groups of adult patients submitted to     laparoscopic cholecystectomy and analgesia from tramadol associated to dipyrone or ketorolac   "
233498|NCT00913692|"     Background:        -  A cold sore is usually a blistering rash on or near the lips, caused by infection with          herpes simplex virus. After the first infection, the virus goes into a dormant          (inactive) state, but it can continue to cause cold sores.        -  Most people with the herpes simplex virus have a few episodes of cold sores per year.          However, some individuals may have many recurrent episodes that are uncomfortable and          may cause embarrassment. Researchers are attempting to find treatments that can decrease          the number of cold sore episodes for people who have six or more episodes per year.        -  Glutamine is a molecule called an amino acid and is one of the components that make up          proteins in the body. Clinical studies using glutamine have addressed the potential of          glutamine to improve immune function and to heal damaged tissue or to help healing.      Objectives:      - To find out if the dietary supplement glutamine can help individuals with frequently     recurring (more than six episodes per year) cold sores.      Eligibility:        -  Patients between 18 and 65 years of age who have a history of having six or more cold          sore episodes per year, and have not received certain kinds of drug treatment for the          cold sores within 1 month of beginning the study.        -  Patients who have two or more episodes of cold sores caused by the herpes simplex virus          will be eligible for treatment as part of this study.      Design:        -  Initial clinical visit for a physical examination and medical history, at which blood          samples will be drawn for testing.        -  Eligible participants will undergo a 4-month screening period. Patients who develop          sores during this period will visit the NIH to have the sore examined to determine if it          is caused by the herpes virus. Patients who have two or more episodes of cold sores          caused by the herpes simplex virus will be eligible for treatment.        -  Patients who are eligible for treatment will provide an initial blood sample and will          receive randomized doses of either glutamine or glycine (another amino acid), which must          be taken on a regular schedule twice daily, mixed with either liquid or soft food.          Patients who develop sores during this period will visit the NIH to have the sore          examined to determine if it is caused by the herpes virus. Blood, urine, and saliva          specimens will be collected each month during the treatment period. A 2-week washout          period will occur between the 2 treatment periods when no doses of glutamine or glycine          will be taken.        -  Patients will then undergo a second 5-month treatment period with either glutamine or          glycine (whichever was not given in the first part of the study), taken in the same          manner as before. Patients who develop sores during this period will visit the NIH to          have the sore examined to determine if it is caused by the herpes virus.        -  After the second treatment, patients will remain in touch with researchers for 1 month          to note any changes.   "
233499|NCT00913705|"     Open-label multicenter randomized Phase III trial.   "
233500|NCT00913718|"     To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine     Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.   "
233501|NCT00913731|"     The purpose of this project is to test the reliability of the FAST-O Rating Scale in patients     at acute wards or psychiatric intensive care units.   "
233502|NCT00913744|"     This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in     subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is     believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic     vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where     this adhesion may be causally associated with worse prognosis).   "
233503|NCT00913757|"     Background:        -  Liver cancer is the third most deadly and fifth most common cancer worldwide.          Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer, and it has          grown more prevalent in the United States.        -  More information is needed about the causes and effects of liver cancer, and further          research into individuals who are at high risk for developing liver cancer is needed for          early diagnosis and prevention.      Objectives:        -  To identify genetic factors that may help to explain the aggressiveness of liver cancer.        -  To determine if HCC biomarkers exist in blood, urine, and tissue samples.      Eligibility:        -  Patients between the ages of 18 and 90 who have been diagnosed with HCC or have a high          risk for developing HCC because of fatty liver disease (alcohol-related or          non-alcohol-related) or chronic hepatitis B or C.        -  Participants will reside in Baltimore City and the surrounding areas.      Design:        -  Participants will complete a questionnaire and provide blood and urine samples for          testing:        -  The questionnaire will include questions about individual and family medical history,          tobacco use, and exposure to known factors for liver cancer.        -  Blood and urine samples will be collected from all participants after the questionnaire.        -  Tumor tissue and healthy tissue will be collected from selected participants if they          undergo surgery for their cancer or disease.        -  No specific treatment will be offered as part of this protocol, but participants have          the option to be treated under different protocols.   "
233558|NCT00914472|"     Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin     sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients     on hemodialysis due to renal failure, through the control of hemostasis, verified by     formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA     and Anti-Xa) during the use of heparin   "
233504|NCT00913770|"     Patients with heroin and prescription opioid dependence are at increased risk for adverse     health consequences and often utilize the Emergency Department (ED) as their source of     medical care. Screening, brief intervention and referral to treatment has been effective in     decreasing high risk behaviors such as alcohol and tobacco use, and unsafe sexual practices.     The data on the effectiveness of brief interventions with opioid dependence is limited. This     prospective, randomized controlled trial of opioid dependent subjects (N=360) will compare     two models of brief intervention with a control condition. ED patients with opioid dependence     will be randomized to either: (1)Screening, Brief Intervention with a Facilitated Referral to     Treatment (SBIRT); (2) Screening, Brief Intervention with ED initiated Buprenorphine     Treatment (SBI+Bup); or (3) standard care (SC) which includes a handout detailing substance     abuse treatment centers in the area. The primary outcome will be self-reported engagement in     formal substance abuse treatment at 30 days, verified by contact with the treatment program.     Other outcomes measured at 30 days, 2, 6 and 12 months include changes in opioid use     (self-report and urine toxicology analysis), HIV risk behaviors, and health care service     utilization. The three interventions will also be compared on their cost-effectiveness. We     will test the hypotheses that SBI+Bup will be superior to SBIRT and SC, and SBIRT will be     superior to SC in (1)increasing the proportion of patients engaged in formal substance abuse     treatment at 30 days; (2) reducing illicit opioid use; (3) reducing HIV risk behaviors; and     (4) reducing health care service utilization. In addition, we hypothesize that the societal     costs of SBI+Bup, per number of days of opioid abstinence, will be cost effective relative to     SBIRT or SC; and that SBIRT will be cost effective relative to SC. Data analyses will be     conducted on the intention to treat sample of randomized patients. This study, conducted by a     research team with extensive experience evaluating brief interventions and treatments for     opioid dependence, will be unique in its: (1) comparison of two models of brief intervention     with standard care; (2) inclusion of an ED initiated treatment arm; (3) use of manual-guided     interventions with systematic assessment of adherence and competence; and (4)collection of     detailed cost data to help guide future healthcare policy.   "
233505|NCT00913783|"     To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg     Clomipramine Hydrochloride capsules under fasted conditions.   "
233506|NCT00913796|"     Acidosis (accumulation of acid in the body) may be an underrecognized problem in patients     after renal transplantation. It may have consequences on physical performance due to negative     effects on bone and muscle metabolism.      Therefore, the purpose of this study is        1. to determine the status of physical capacity and bone structure in renal transplant          patients with metabolic acidosis        2. to study the effect of substituting base equivalents (citrate) on acid/base status of          renal transplant patients with acidosis        3. to compare the status of physical capacity and bone structure in renal transplant          patients with metabolic acidosis before and after substitution with citrate   "
233507|NCT00913809|"     To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to     Merrell Dow's 100 mg Norpramin tablets.   "
233508|NCT00913822|"     To demonstrate the relative bioavailability of Desipramine Hydrochloride tablets.   "
233509|NCT00913835|"     The purpose of this study is to determine if participants with platinum-refractory or     platinum-resistant advanced ovarian cancer have a better outcome when treated with Olaratumab     (IMC-3G3) in combination with Liposomal Doxorubicin than when treated with Liposomal     Doxorubicin alone.   "
233510|NCT00913848|"     To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release     tablets under fed conditions.   "
233514|NCT00913900|"     Peripheral artery disease (PAD) due to leg artery blockages can result in painful leg     muscles, skin ulcers and infection due to poor blood flow. In severe forms, the only     treatment may be amputation. Adult stem cells injected into affected legs may cause new blood     vessel formation and improve blood flow. The purpose of this study is to determine the     feasibility and safety of injecting adult stem cells into the leg muscles of patients with     severe PAD, in an attempt to improve blood flow.   "
233515|NCT00913913|"     Immune therapies, such as a IL-2, for metastatic renal cell carcinoma (mRCC) are designed to     mobilize immune effector cells that recognize and destroy cancer. The investigators have     recently observed a 50% objective response rate (16% CR) in mRCC patients treated with     autologous tumor lysate -dendritic cell (DC)-vaccine, IL-2 and interferon alfa (IFN). New     agents inhibiting vascular endothelial growth factor (VEGF) pathways have demonstrated     significant benefit in mRCC patients as well, but rarely induce CRs. High blood VEGF is     associated with poor response to IL-2 and can cause tumor specific immune dysregulation. To     test whether complementary mechanisms of immune activation and disruption of regulatory     pathways enhance outcome the investigators plan to treat 24 mRCC patients in a phase II trial     using bevacizumab, DC vaccine, IL-2, and IFN. Observations from this project will be used in     the development of novel cancer therapies which, if successful, will decrease the burden of     cancer on the public.      The investigators propose to determine 1) the objective clinical response rate to treatment     and progression free survival, 2) the clinical and autoimmune related toxicity profile of     therapy, and 3) the treatment related tumor-specific immune response and the relationship of     tumor-specific immune response and objective clinical response.   "
233516|NCT00913926|"     Aim of this NIS is to obtain further information on efficacy, tolerability, and acceptance of     Wellnara in a large user population under the conditions of routine medical practice.     Furthermore, any adverse drug reactions will be recorded in a large user population under the     conditions of medical routine. To investigate the efficacy of Wellnara, patients will fill in     a questionnaire, the so-called Menopause Rating Scale (MRS II). Further, the effects of     treatment on skin and hair will be evaluated by the investigator. Patients will assess     treatment effects on their sexual life. Safety parameters include monitoring of vaginal     bleeding, measurement of blood pressure and body weight, and - as far as routinely used in     the practice - calculation of waist-hip-ratio. Any relevant additional information related to     adverse drug reactions will also be documented.   "
233528|NCT00914082|"     Labour pain is a challenge to the parturient woman. Pain relief methods during birth are     limited and often associated with side effects. Several studies indicate that a mental     trainings method, self hypnosis, has a positive impact on the labour pain and other birth     outcomes.      The aim of this randomized controlled study is to examine the effect of a short antenatal     course in self hypnosis on the use of epidural analgesia during birth and several other birth     outcomes. Data collection includes questionnaires, register data, medical records and     biological material.   "
233559|NCT00914485|"     The proposed research will provide important insight into two serious problems for veterans'     healthcare: 1) mixed effectiveness of communication improvement interventions in the VA to     date, and 2) persistence of racial/ethnic disparities in VA healthcare.   "
233560|NCT00914498|"     This study will examine whether pre-incision infiltration of the skin cut site can attenuate     post operative pain after a cesarean section. One hundred and twenty women will be allocated     to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. We will also     examine possible effect of this infiltration of parameters of wound heeling and scar     formation, six weeks post partum.   "
233517|NCT00913939|"     This pilot study initiates a research program testing the early technical and clinical     performance of a novel procedure for MRI-guided high-dose-rate (HDR) prostate brachytherapy.     Testing will proceed in two cohorts of patients. In Arm 1, patients with locally recurrent     prostate cancer after radiotherapy will receive tumor-targeted salvage HDR brachytherapy. Arm     1 of the study will be coordinated and closely integrated with a separate concurrent study of     MRI-guided prostate biopsy, which will be performed prior to accrual to Arm 1 of this trial     (UHN 05-0641-C). In arm 2, patients with locally advanced prostate cancer will receive a     boost of prostate-targeted HDR brachytherapy during external beam radiotherapy.      This technique will be prospectively evaluated in up to 100 patients. Preliminary data     acquired in this pilot study will determine the technical limits of MRI guided HDR     brachytherapy and will be critical for the judicious conduct of a subsequent phase II     clinical trial.      This proposal is innovative in two fundamental ways: MRI-guidance, and specific tumor     targeting for HDR brachytherapy. Successful completion of this study will further     individualize local therapy, not only for the benefit of the proportion of cancer patients     for whom initial radiotherapeutic interventions have failed, but also provide valuable     technical and clinical validation that these novel image-guided (IG) approaches are     clinically feasible and could be applied more broadly in prostate cancer therapy.   "
233518|NCT00913952|"     To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg     Clomipramine Hydrochloride capsules under fed and fasted conditions.   "
233519|NCT00913965|"     To demonstrate the relative bioavailability of Atenolol tablets.   "
233520|NCT00913978|"     Subjects will participate in this study because they are undergoing scheduled abdominal     surgery. The usual standard care participants receive in the operating room include     maintaining normal temperature during planned surgical procedure. The anesthesiologist and     staff will use warm blankets, warm air and warmed intravenous fluids (fluid given into the     patient's IV). This study will evaluate the timing of applying warming devices and evaluating     whether there is a difference between the timing and the patient's post operative recovery.     Maintaining normothermia in this group of patients will lead to a decreased 30 day morbidity     and mortality.   "
233521|NCT00913991|"     Systolic Hypertension is a disorder which is characterized by significant elevations in     systolic blood pressure in association with normal diastolic blood pressure. Typically, this     develops in individuals >50 years of age and is associated with an increased risk of stroke     and myocardial infarction. While there are many effective therapies for essential/diastolic     hypertension, the treatment of systolic hypertension is complicated by side effects from     traditional therapies. This limits therapeutic options and has resulted in a number of     at-risk individuals being left untreated.      We are conducting a randomized, controlled trial (n=90) to compare the effects of two     different stress management training on blood pressure. The primary outcome is change in     systolic blood pressure and pulse pressure. Secondary outcomes are changes in nitric oxide,     stress hormones and psychological well-being. Additional analyses will be conducted to assess     for other confounding effects on BP and PP.   "
233522|NCT00914004|"     To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg     Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets.   "
233523|NCT00914017|"     There is laboratory evidence that cholesterol lowering medications (statins) inhibit the     growth of breast cancer cells. Clinical studies are controversial but some show that women     taking statins are less likely to get breast cancer. This ongoing randomized trial compares     one-year of atorvastatin (Lipitor™) or placebo for lowering mammography-defined breast     density and other surrogate markers associated with breast cancer risk.   "
233537|NCT00914199|"     Should we, or should we not, perform dilatation of the side branch through the main vessel     stent, if there is acceptable blood flow in the side branch?   "
233524|NCT00914030|"     The aim of the protocol is to better understand the impairments in visual processing, as such     impairments may induce social interaction difficulties in subjects with autism spectrum     disorders (adults and children) and schizophrenia, like face exploration.The same protocol     will be used for the three populations, each population being compared with matched controls.     The explorations are designed to test two different hypotheses regarding the mechanisms of     the visual perception difficulties of the two populations. Even though difficulties to     extract the global form of objects have been described in both subjects with autism and     schizophrenia, we will test two different hypotheses for the two populations. We will test     the hypothesis that subjects with autism display an advantage for the processing of local     information arising at an early level of processing, whereas disorders observed in patients     with schizophrenia originate from attention disorders. The protocol includes three     consecutive studies, each one being applied in each of the three populations.   "
233525|NCT00914043|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to     fatigue.      PURPOSE: This research study is looking at biological markers of fatigue in women with     residual invasive breast cancer enrolled on clinical trial NSABP-B-45.   "
233526|NCT00914056|"     After resolution of the initial episode of hepatic encephalopathy (HE), lactulose is     routinely continued indefinitely as maintenance therapy. Although widely used for this     indication, lactulose has never been shown in randomized, controlled trials to be effective     for preventing exacerbations of HE. Indeed, lactulose was found to be ineffective at     preventing HE when administered prophylactically to patients undergoing portosystemic shunt     insertion. While some patients may be lactulose dependent following an initial episode of HE,     it is likely that most could have their lactulose discontinued with no adverse consequences.      This goal is worth pursuing because lactulose is not innocuous. It has an unpleasant taste,     and it routinely produces gastrointestinal symptoms, including bloating, gas and diarrhea. In     high doses it can cause incontinence, dehydration and electrolyte derangements. Patients     universally dislike taking lactulose and often are noncompliant with treatment. A recent     trial showed that patients on lactulose had a substantial risk of hospital admissions due to     lactulose-related complications and treatment non-compliance.   "
233527|NCT00914069|"     The study will test a hypothesis that the RIVS system will have a higher rate of successful     first PIV placement compared to conventional catheter without a significant increase in     complications and time of procedure.   "
233529|NCT00914095|"     Therapeutic management of gait disorders in very advanced Parkinson's disease (PD) patients     can sometimes be disappointing, since dopaminergic drug treatments and subthalamic nucleus     (STN) stimulation are more effective for limb-related Parkinsonian signs than for gait     disorders. Gait disorders could be also partly related to noradrenergic system impairment,     pharmacological modulation of both dopamine and noradrenaline pathways could potentially     improve the symptomatology. The investigators have demonstrated using an open label study on     17 advanced PD patients that chronic, high doses of methylphenidate (MPD) improved gait,     freezing of gait, motor symptoms and attention in the absence of L-Dopa and increased the     intensity of response of these symptoms to L-Dopa (Devos et al., 2007). The investigators     aimed to confirm their results using a randomized, double-blind, placebo-controlled,     parallel-group, multicentric trial. The investigators will assess the clinical value of     chronic, high doses (1 mg/kg/day) of MPD vs placebo in 88 non demented PD patients suffering     from severe gait disorders with freezing despite their use of optimal dopaminergic doses and     eventually STN stimulation parameters. Efficacy will be assessed directly and on video in the     absence of L-Dopa and again after acute administration of the drug, both before and after a     3-month course of MPD, using Stand Walk Sit test (primary criteria), the Freezing Of Gait     trajectory, RGSE scale, the UPDRS scores, the dyskinesia rating scale, Achiron scales and     using auto-questionnaires of Giladi, ABC scale and PDQ 39. Attention will be assessed using     reactions times. Drowsiness will be assessed using Epworth and Parkinson's disease Sleep     Scales. Apathy and depression will be monitored with Lille Apathy Rating Scale, MADRS, BPRS,     MINI and psychiatric interview. Cardiologic and general tolerance will be also monitored.     This study could lead to propose methylphenidate with a good efficacy/ risk balance in     advanced PD patients suffering from severe gait disorders with freezing of gait, drowsiness     and attention deficit.   "
233530|NCT00914108|"     The purpose of the study is to learn more about the development of small for gestational age     (SGA) preterm infants and whether focusing on the infant's behavior has a positive effect on     outcome. The study hypotheses state: 1) High risk severely SGA preterm infants will profit     from detailed neuropsychological assessment, psychoeducational recommendations and practical     guidance for caregiving, as well as formal educational and emotional support for the family     and the professional care team. 2) Neuropsychological education and guidance for     community-based early intervention providers caring for SGA preterm infants after their     discharge is effective in promoting improved outcome.   "
233531|NCT00914121|"     The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart     (cardiac repolarization)   "
233532|NCT00914134|"     The aim of the study is to assess the effect of continuous levodopa infusion on autonomic     nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and     sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis     and orthostatic hypotension.   "
233533|NCT00914147|"     RATIONALE: Measuring how well the lungs work in patients with cancer may help doctors predict     how patients will respond to treatment and help plan the best treatment.      PURPOSE: This clinical trial is studying lung function testing in patients with locally     advanced or metastatic solid tumors.   "
233534|NCT00914160|"     To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets     under non-fasting conditions.   "
233535|NCT00914173|"     The clinical trial is intended to implement, validate performances and evaluate efficacy of     the pain monitoring device for automated assessment of patient's pain level. The efficacy of     the pain monitor will be tested by comparing its results to the patient pain reports towards     a given pain stimuli.   "
233536|NCT00914186|"     The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and     tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe     pruritus (itching), following a 28-day regimen of twice-daily topical application.   "
233539|NCT00914225|"     In many areas of the world most severely affected by the HIV/AIDS pandemic, insect and     water-borne diseases such as malaria and diarrheal disease are common causes of illness and     death. In addition, diarrhea and malaria are more common and more severe among adults and     children infected with HIV. These infections may modulate the immune system, affect the     replication of the HIV virus and could result in more rapid HIV disease progression in     co-infected individuals. Access to practical, inexpensive and easy to use interventions to     prevent these diseases may be effective in delaying HIV progression.      Current Kenya government and World Health Organization guidelines recommend the use of     cotrimoxazole (trimethoprim-sulfamethoxazole [TMP/SMX]) to prevent co-infections, including     malaria. Despite the provision of TMP/SMX to HIV-infected adults, infections with malaria and     pathogens causing diarrhea remain common causes of morbidity and mortality in many     resource-limited settings. In addition, TMP/SMX may not prevent all infections with malaria     or other pathogens due to alternative mechanisms of action, antimicrobial resistance and     non-compliance due to adverse events or other reasons.      We propose a study to evaluate the impact of providing insecticide treated bednets and a     simple water filtration device on markers of HIV disease progression among a cohort of ART     naïve, HIV infected adults prescribed TMP/SMX in Kenya. In addition, we propose to evaluate     the effect of these interventions on malaria and diarrheal disease incidence and on     compliance with TMP/SMX.   "
233540|NCT00914238|"     In a randomized clinical trial, the researchers want to investigate if the positive     short-term outcomes (first 1-2 years), achieved with specialized assertive intervention     programme (OPUS), can be maintained for five years if the specialized treatment is sustained     over the first five years in comparison to only two years of specialized treatment followed     by three years of standard treatment.   "
233541|NCT00914251|"     It has been suggested that cardiovascular risk factors either independently or in cluster     (metabolic syndrome) increase the risk of both type 2 diabetes (DM2) and cardiovascular     diseases (CVD). Consumption of citrus fruits is linked to reduced cardiovascular morbidity     and mortality. Hesperidin is a flavanone abundant in citrus fruit with putative vasodilator     actions in vitro. While molecular mechanisms of vascular actions of hesperidin begin to be     explored, no data on in vivo vascular effect of this flavanone has been ever acquired.   "
233554|NCT00914420|"     Patients presenting with ACS (Acute Coronary Syndrome) in the emergency department will be     screened for clinical eligibility and asked to sign informed consent to the study.      A total of 40 patients will be randomized. 20 of them will receive a Trapidil eluting stent     (Intrepide™ stent), 20 will receive a Paclitaxel eluting stent (Taxus™ stent). After 90 days     the patients who were treated with the INTREPIDE stent in the first lesion will be treated     with the Taxus stent in the second lesion. After 90 days the patients who were treated with     the Taxus stent in the first lesion will be treated with the INTREPIDE stent in the second     lesion.      Coronary angiography will be performed through the femoral (groin) or radial (wrist) artery     with the use of standard techniques. The doctor will determine if the patient is qualified     for enrolment at the end of the diagnostic coronary angiogram   "
233542|NCT00914264|"     1. The first objective of this study is to determine the differences between, while the          airway obstruction severity is the same, and the acute continuous positive airway          pressure (CPAP) effect on chronic obstructive pulmonary disease (COPD) patients with          overlap syndrome compared with COPD patients without in terms of sleep quality,          autonomic nerve activity, biologic markers of systemic inflammatory, and exercise          performance.        2. The second objective of this study is to evaluate the subacute (3 months treatment) CPAP          effect on COPD patients with overlap syndrome in terms of pulmonary hemodynamic and          right heart function, We will also determine the subacute effect of CPAP on sleep and          life quality, autonomic nerve activity, biologic markers of systemic inflammatory, as          well as exercise performance.        3. The last objective of this study is to evaluate the long term (12 months treatment) CPAP          effect on COPD patients with overlap syndrome. The un-scheduled clinic or emergency          department visiting, hospitalization, or mortality will be recorded to see if there is          significant treatment effect in terms of reducing morbidity and mortality. The long term          CPAP effect on sleep and life quality, autonomic nerve activity, biologic markers of          systemic inflammatory, exercise performance, as well as pulmonary hemodynamic and right          heart function will be re-evaluation.   "
233543|NCT00914277|"     The primary objective of this clinical trial is to study the ability of SAR407899 to increase     the duration of penile erection in male patients with mild-moderate Erectile Dysfunction.      The secondary objectives of this clinical trial are to study the ability of SAR407899 to     shorten increase the time to erection duration of penile erection in male patients with     mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of     SAR407899 in these patients.   "
233544|NCT00914290|"     To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation     of symptoms of spasticity associated with multiple sclerosis (MS).   "
233545|NCT00914303|"     The aims of the study are to assess the safety, tolerability and pharmacokinetics of ER     tablets of AZD3241 following multiple ascending doses administered to healthy male and female     subjects including the effect of food.   "
233546|NCT00914316|"     The goal of this study is to evaluate whether supervised treadmill exercise combined with     ranolazine 1000 mg twice daily provides an incremental benefit in absolute walking distance     over supervised exercise alone in patients with stable claudication. Investigators also seek     to determine if the administration of ranolazine provides a sustained benefit after the     completion of a supervised exercise regimen. Lastly, investigators wish to determine whether     both exercise and ranolazine improves peak oxygen consumption and anaerobic threshold in     patients with stable claudication.   "
233547|NCT00914329|"     To evaluate the effectiveness of Gelsemium sempervirens 5CH et 15CH on anticipatory provoked     anxiety, in healthy volunteers.   "
233548|NCT00914342|"     The purpose of the study is to provide data on the GERD prevalence as percentage of patients     with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire.     Furthermore the study aims to estimate GERD prevalence in patients based on their symptoms as     they respond to a physician's questionnaire, to observe possible variations between the two     methods (physicians' symptom rating and GerdQ), to objectively measure treatment response and     to identify the percentage of patients that may require alterations of their treatment.     Finally, to describe the impact of GERD symptoms on work productivity.   "
233549|NCT00914355|"     This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce     tumour size, slow progression of the disease, prolong life and improve quality of life of     patients with hepatocellular carcinoma, a cancer of the liver, that cannot be removed     surgically (unresectable) and cannot be treated with ablative therapy (e.g. radio-frequency     ablation) or trans-arterial chemo-embolization (TACE) therapy (delivery of chemotherapy     through an artery that feeds into the liver). SBRT is concentrated focused radiation therapy     delivered very precisely to the liver tumour. It is hoped that knowledge obtained from this     study will improve our ability to treat patients with liver tumours that cannot be treated     with surgery and other methods, and that SBRT may prove to be a treatment that can lead to     long-term and permanent control of liver tumours for some patients.   "
233552|NCT00914394|"     Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance     to changes in perfusion pressure. In the eye, several studies have reported that retinal     blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale     studies have shown that reduced ocular perfusion pressure is an important risk factor for the     prevalence, the incidence and the progression of primary open angle glaucoma.      Former studies that investigated ocular blood flow autoregulation focused mainly on choroidal     blood flow. For the optic nerve head only few data are available, although it seems likely     that it underlies similar autoregulatory mechanisms.      A previous study investigating choroidal blood flow has shown that nitric oxide (NO) plays a     key role in choroidal autoregulation. The present study is designed to test the hypothesis     that NO plays a role in optic nerve head autoregulation during increased intraocular pressure     (IOP). Therefore, IOP will be experimentally increased using a suction cup device in the     absence of presence of either a nitric oxide synthase inhibitor (L-NMMA), an α-receptor     agonist (phenylephrine) or placebo. Optic nerve head blood flow will be continuously measured     during the procedure.   "
233553|NCT00914407|"     The inner retina is crucially dependent on an adequate retinal blood supply. When the retina     becomes ischemic and hypoxic this results in severe vision loss due to retinal     neovascularization. Measurement of retinal blood flow and retinal oxygenation is, however,     still a difficult task. Information on retinal oxygenation is almost unavailable from human     studies. In the present protocol the investigators propose a procedure allowing for the     measurement of retinal blood flow, retinal oxygenation and retinal oxygen extraction by     combining a number of innovative techniques. Specifically, retinal vessel diameters will be     measured with a Retinal Vessel Analyzer, retinal blood velocities with bi-directional laser     Doppler velocimetry and retinal oxygenation with spectroscopic evaluation of retinal fundus     images. This will allow for the calculation of retinal oxygen extraction, a fundamental     parameter of retinal function. Up to now, no data for retinal oxygen extraction are available     in the literature.   "
233555|NCT00914433|"     This study will look at the safety and tolerability of TPI 1100 in healthy volunteers and     look at pharmacodynamic (PD) effect on mRNA expression of PDE 4B/D & 7A in blood and in     sputum.   "
233562|NCT00914524|"     The treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg,     20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. The primary endpoint for     efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of     treatment. The secondary endpoint was creatinine clearance (Ccr).   "
233563|NCT00914537|"     Background:        -  HIV-positive men who have sex with men (MSM) have rates of anal cancer that approach          those of cervical cancer in women. However, unlike cervical cancer, there is no current          recommended method of screening that could be used to detect anal precancerous lesions          for the prevention of anal cancer in HIV-positive MSM.        -  Infections by human papillomavirus (HPV) are the likely cause of cervical and anal          precancer and cancer. Detecting the presence of HPV or related biomarkers has helped to          identify women who may be at increased risk of cervical cancer; researchers believe that          early detection of HPV or related biomarkers in MSM may be useful for anal cancer          screening.      Objectives:      - To evaluate the effectiveness of various tests to detect cancer-causing HPV in HIV-positive     men who have sex with men.      Eligibility:      - HIV-positive MSM that are interested in receiving anal screening for precancer      Design:        -  HIV-positive MSM will respond to a self-administered risk factor questionnaire, and will          undergo a physical exam and a high-resolution anoscopy at the participating clinic.        -  The clinician will then collect to anal Pap specimens from each subject for research on          HPV and related biomarkers.        -  Participants will be followed annually for 2 years to collect additional health data for          research follow-up.   "
233564|NCT00914550|"     The purpose of the study is to learn if a blood test is helpful to the doctors in deciding     whether you need antibiotic therapy for possible pneumonia. The blood test is called a     Procalcitonin level and sometimes the test reflects infection with certain bacteria (germs).     When the doctors learn the results of these blood tests, they may be able to stop some of the     antibiotic medications that they may have given to the patients. The study is designed, so     that on a randomized basis (50/50 chance) the results from measuring Procalcitonin will be     given to the patients' doctor. When the doctor receives these results, he/she may use this     information, along with other information, to decide whether to continue antibiotic therapy.   "
233565|NCT00914563|"     Fluid Therapy Lithium Dilution Cardiac Output (LIDCO) controlled trial in BURNS (FACT in     BURNS) is a prospective randomized multicentric study.      Introduction: The goal of this trial is the verification, optional upgrading and optimizing     of the resuscitative patterns in light of the new generation of balanced crystalloids and     colloids and, by utilization the non-invasive hemodynamic monitoring LIDCO.   "
233566|NCT00914576|"     Oxidative stress has been implicated in playing a pathogenic role in many disease processes,     especially in age-related disorders. It has been hypothesized that antioxidative agents such     as vitamins and minerals, which are capable of scavenging free radicals, may reduce oxidative     stress and may, in turn, be beneficial for patients with age-related disorders. Based on this     hypothesis, several different combinations of vitamins have been introduced, all targeting at     reducing oxidative stress. However, the in-vivo determination of the antioxidative properties     of a certain drug or vitamin combination are hard to determine. In the current study, the     researchers propose to investigate the effect of VITAMAC®, a combination of vitamins and     minerals, in a systemic in-vivo inflammation model.      In the present study, the infusion of LPS, which is a cell wall component of Gram-negative     bacteria and a major mediator in the pathogenesis of septic shock, will be used as a     standardized experimental model of systemic inflammation in humans. Given that inflammation     is associated with enhanced oxidative stress and widespread endothelial dysfunction, the LPS     model is well suitable for determination of the antioxidative effects of VITAMAC®. As a main     outcome parameter, the vascular reactivity of retinal vessels to systemic hyperoxia (induced     by breathing 100% oxygen) will be tested in presence or absence of the antioxidant     combination.   "
233567|NCT00914589|"     This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to     investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart     surgery.   "
233568|NCT00914602|"     The purpose of the study is to assess the pharmacokinetics (PK), pharmacodynamics, and safety     of XP21279 sustained release (SR3) formulation [administered with Lodosyn® (carbidopa)] and     Sinemet® tablets in subjects with Parkinson's disease with Motor Fluctuations.   "
233569|NCT00914615|"     This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce     tumour size, slow progression of the disease, prolong life and improve quality of life. SBRT     is concentrated focused radiation therapy delivered very precisely to the liver tumour.      Presently, the treatment for unresectable liver metastases from colorectal cancer is most     often chemotherapy or novel targeted therapy. These treatments may improve survival, but not     control the metastases permanently; so new treatments are needed to control metastases. It is     hoped that knowledge obtained from this study will improve our ability to treat patients with     liver tumours that cannot be treated with surgery and other methods, and that SBRT may prove     to be a treatment that can lead to long-term and permanent control of liver tumours for some     patients.   "
233570|NCT00914628|"     The main objective of this randomized trial is to compare disease-free survival (DFS) in high     risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of     HSV-Tk donor lymphocytes or standard haploidentical HCT   "
233571|NCT00914641|"     To estimate the pharmacokinetics of apixaban when administered as three different modified     release formulation tablets relative to that when apixaban is administered as an immediate     release tablet   "
233572|NCT00914654|"     The purpose of the study is to assess the blood and urine concentrations of inhaled     formoterol.   "
233573|NCT00914667|"     This is an open-label, randomized, two-way crossover study to evaluate the steady-state     effect of fesoterodine (8 mg QD) on the pharmacodynamics and pharmacokinetics of a single     supratherapeutic dose of warfarin (25 mg) in healthy subjects.   "
233574|NCT00914680|"     This treatment pilot study will investigate clinical efficacy and adverse effects of magnetic     seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive     episode. The investigators will perform add-on tests to assess clinical and cognitive     response to treatment. It is hypothesized that MST will have an antidepressant efficacy with     a beneficial neurocognitive adverse effect profile.   "
233576|NCT00914706|"     The purpose of this study is to evaluate the impact of using a web-based (P-PROMPT) chronic     disease management system (CDMS) by primary care practitioners and their team members and on     their care for patients with diabetes. The system will help to ensure that all patients have     up-to-date laboratory monitoring and visits as recommended by the Canadian Diabetes     Association Guidelines. The hypothesis is that the use of a CDMS in Ontario primary care     practices, as a part of the routine clinical management of diabetes patients, can improve     monitoring frequency of A1C, blood pressure (BP) and cholesterol levels. The results of this     study will serve as a benchmark for the utilization of chronic disease management software     tools in primary care diabetes management for patients in Ontario, establishing and providing     evidence to inform decision-makers. If the results are favorable towards CDMS interventions     for the management of diabetes, potential expansion and availability of these types of     programs may be possible for other chronic diseases.   "
233590|NCT00914888|"     The main purpose of this study is to compare the safety of tigecycline versus a ceftriaxone     regimen in pediatric subjects (aged 8 to 17 years) with complicated intra-abdominal     infections (cIAI) and community acquired pneumonia (CAP).   "
233591|NCT00914901|"     The purpose of the study is to assess the blood and urine concentrations of inhaled     salmeterol.   "
233592|NCT00914914|"     The purpose of this study is to evaluate the safety of an experimental drug (p28) as a     treatment for certain advanced cancers which express a protein called p53 and which have not     responded to prior treatment.   "
233577|NCT00914719|"     Adolescents are at great risk for sexually transmitted diseases (STDs) including the human     immunodeficiency virus (HIV) (CDC, 2000a; DiLorenzo & Whaley, 1999). Though the CDC (2000b)     reports that overall AIDS incidence is on the decline, there has been no comparable decline     in the number of newly diagnosed HIV cases among young people aged 13-19, and young people of     color are particularly at risk. Compared to the general adolescent population, adolescents     involved with the criminal justice system are younger at first intercourse, have a greater     number of sex partners, and lower rates of condom use, resulting in higher rates of     unintended pregnancy and STDs (e.g., St. Lawrence et al., 1999). Alcohol use is commonly     cited as a reason for lack of condom use among high-risk adolescents such as those involved     in the criminal justice system (e.g., Morris et al., 1998) and recent data from our research     suggests that it is heavy alcohol use in concert with sexual activity that is most strongly     related to lack of condom use (Bryan, Rocheleau, & Robbins, 2002a). The goal of this research     is to design, implement, evaluation, and disseminate a successful HIV/STD risk reduction     intervention that is theory-based, empirically targeted to adolescents, and articulated to a     criminal justice setting. The study compares a sexual risk reduction intervention with a     group motivational interviewing alcohol component to a standard sexual risk reduction     intervention and a no treatment control condition. The investigators hope to show that: 1) A     three-hour one-time intervention has the capacity to reduce sexual risk behavior up to one     year post-release among high risk adolescents in detention, 2) A combined sexual and alcohol     risk reduction intervention will result in larger decreases in sexual risk behavior than a     sexual risk reduction alone, 3) The interventions will exert their effects through changes in     mediators derived from a theoretically-based model of condom use intentions and behaviors,     and 4) A sexual risk reduction intervention including an alcohol component will be especially     effective for those adolescents with higher levels of existing alcohol problems. Finally,     given proven efficacy, the intervention curricula and materials will be disseminated for use     in adolescent detention facilities throughout the state.   "
233578|NCT00914732|"     Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to     improve its ability to protect citizens against the smallpox virus. This study will evaluate     safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the     immune system (the body's defense system). Two vaccine preparations have the same name but     one is a liquid and one is a powder that has liquid added just before it is given. The     vaccine that comes as a liquid will be injected (given as a shot) just under the skin     (subcutaneously) or injected between the layers of the skin (intradermally). The powder     formulation is only injected just under the skin. Approximately 495 adults, age 18 older born     after 1971, which have not had smallpox vaccine before, may participate in the study for     about 7 months.   "
233579|NCT00914745|"     About 80% of the worldwide population is positive on HSV antibodies. In the United States the     lifetime prevalence of recurrent herpes labialis is estimated at 20% to 40%, with     approximately 100 million episodes occurring in the country every year. In Switzerland about     70% of the adult population is positive on HSV-1 and about 20% is positive on HSV-2.      The Herpes simplex virus has a lipid bilayer (virus-envelope), which causes the     sensitiveness, to any kind of detergents. Within this bilayer cholesterol molecules are     integrated and play a crucial role in virus entry into host cells. In vitro experiments have     clearly shown that the depletion of cholesterol in HSV-envelope with 2- HPßCD has inhibited     the ability of the virus to infect host cells.      The aim of this clinical trial is to reduce the number of Herpes labialis relapse and to     provide patients with recurrent Herpes labialis a real benefit, concerning the simple     mechanism of action and the negligible side effects. Patients having problems in swallowing     the antiviral pills of standard treatment, will find with 2- HPßCD a drug, that just has to     be applied on the lips, which increases patient's quality of life tremendously.        -  Trial with medicinal product   "
233580|NCT00914758|"     People with multiple sclerosis (MS) often experience problems with cognitive functioning,     which can be debilitating and interfere with their daily functioning. However, research has     shown that MS disease modifying agents have had some success in treating cognitive problems.     The main purpose of this research study is to investigate how well two medicines (alemtuzumab     (Campath®) and interferon beta-1a (Rebif®)) work in treating MS-related cognitive problems     (e.g., attention, memory, speed of thinking). Participants enrolled will be assessed prior to     their first study-related medication dose and re-assessed throughout treatment. It is     expected that participants taking Campath® will demonstrate relative stability in cognitive     functioning relative to those taking Rebif®. Specifically, the cognitive performance of     Rebif® participants will decline somewhat over time, but the cognitive performance of     Campath® participants will remain stable.   "
233581|NCT00914771|"     This study aims to demonstrate the non-inferiority of two doses of H5N1 influenza antigen in     non-elderly and elderly adult subjects in order to submit an extension application for a     lower dose of Focetria.   "
233632|NCT00915447|"     The purpose of this study is to measure the effects of allergens and/or diesel exhaust     particles in the nose to learn more about allergic responses in individuals with cat allergic     rhinitis.   "
233633|NCT00915460|"     To collect data on serious adverse events which occur during extended treatment with Avonex     in subjects at high risk for developing multiple sclerosis (MS) and in subjects with     secondary progressive MS.   "
233720|NCT00906672|"     Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the     innovative technique Integra® and the technique of reference: the flap surgery.   "
233582|NCT00914784|"     Currently Transfusion-related acute lung injury (TRALI) is the leading cause of     transfusion-related mortality in the United States, and one of major post-transfusion     complications. TRALI is defined as new ALI occurring within 6 hours from the onset of     transfusion. It is manifested by acute dyspnea, hypoxemia and bilateral infiltrates in chest     radiograph. TRALI may be caused by any blood product and is not dose-dependent. Associated     risk factors include prolonged storage of blood products and underlying conditions such as     severe IHD hematologic malignancies or active infections. Since TRALI has only recently been     defined as a clinical entity, and its prevalence has been largely underestimated - the     epidemiology of TRALI is not well established. Therefore the objective of this work is to     study the incidence of TRALI in a patient population that receive blood products frequently,     namely orthopedic-oncologic.   "
233583|NCT00914797|"     The purpose of this study is to assess the blood and urine concentrations of terbutaline and     to evaluate the difference between inhaled and oral terbutaline in order to distinguish     treatment with terbutaline from doping with terbutaline in a doping control.   "
233584|NCT00914810|"     The purpose of this study is to determine whether or not vitamin D supplementation can     improve physical performance in persons with severe chronic obstructive pulmonary disease     (COPD).   "
233585|NCT00914823|"     The investigators are seeking participants for a study of the role of kisspeptin in the     reproductive system. Kisspeptin is a naturally occuring hormone in humans that stimulates the     production of reproductive hormones. The investigators hypothesize that kisspeptin     administration will be a useful tool for characterizing certain reproductive disorders.   "
233586|NCT00914836|"     The use of corticosteroid subacromial injections have been found to be effective for the     treatment of shoulder pain. Higher doses may be better than lower doses for subacromial     corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to     compare 2 doses of corticosteroids.   "
233587|NCT00914849|"     To reduce the number of donors treated with IV AMD3100 who require a second collection to     obtain the minimum cells necessary for allogeneic stem cell transplant.   "
233593|NCT00914927|"     The purpose of this study is to evaluate the efficacy of once-daily Oral E5501 in subjects     with chronic liver diseases and thrombocytopenia prior to elective surgical or diagnostic     procedures, to evaluate the safety of short-term administration of E5501 and to evaluate the     pharmacokinetics (PK) of E5501.   "
233594|NCT00914940|"     RATIONALE: Allogeneic hematopoietic stem cell transplant (HSCT) is a treatment that can cure     acute leukemia and myelodysplasia. After giving the patient chemotherapy and total body     irradiation to stop the growth of cancer and remove the patient's diseased bone marrow,     healthy stem cells from a donor are infused into the patient to replace the patient's bone     marrow and make red and white blood cells and platelets. Unfortunately HSCT is often     complicated by 'graft versus host disease' (GVHD) in which the transplanted cells from a     donor can make an immune response against the body's normal cells and cause tissue damage and     severe symptoms. Removing a subset of the donor T cells, called 'naive T cells', before     transplant may reduce the frequency and intensity of GVHD.      PURPOSE: This phase II trial will determine whether the removal of the naive T cells from     donor cells can decrease the rate and severity of graft-vs-host disease while preserving     specific immunity against infections in patients with acute leukemia or advanced     myelodysplastic syndromes.   "
233595|NCT00914953|"     This study will investigate if intranasal oxytocin (a hormone naturally produced in the body)     promotes motivation for, and engagement in, social activities in older adults.   "
233596|NCT00914966|"     The objectives of the study were:        1. To assess the safety and tolerability of escalating doses of CINRYZE.        2. To assess the effect of an escalating dose algorithm for CINRYZE on hereditary          angioedema (HAE) attack rates.        3. To assess the immunogenicity of CINRYZE.   "
233597|NCT00914979|"     Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of     bifurcation lesions in native coronary arteries.   "
233598|NCT00914992|"     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in     perfusion pressure. The existence of an effective autoregulation in the optic nerve head     (ONH) circulation has been shown in animals and humans. Moderate elevation of intraocular     pressure (IOP) caused only slight effect on ONH blood flow in monkeys, cats and rabbits. In     humans, during an artificial IOP rise using a suction cup method the ONH blood flow maintains     almost constant until IOP reaches 40-55 mmHg. During isometric exercise the upper limit of     autoregulation appears to be approximately 40% above the baseline ocular perfusion pressure.     The mechanism behind ONH blood flow autoregulation is still unknown. The present experiments     are designed to improve the investigators' knowledge of the physiology of regulatory     mechanisms in ONH circulation, which may be helpful for a better understanding of blood flow     abnormalities in glaucoma. This is of importance, because there is increasing evidence that     vascular dysregulation plays a role in the development of glaucomatous damage.   "
233599|NCT00915005|"     The goal of this clinical research study is to learn if, compared with regular x-ray     radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis     (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in     patients with lung cancer.   "
233600|NCT00915018|"     This study is investigating the effects of an experimental drug (neratinib) in combination     with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women     who have not received previous treatment for erbB-2-positive locally recurrent or metastatic     breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors     and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will     also compare the safety of the two regimens and as well as the quality of life of subjects     receiving either regimen.   "
233601|NCT00915031|"     Robotic assisted laparoscopic radical prostatectomy (RLP) has gained widespread acceptance as     a standard treatment for clinically localized prostate cancer. Despite the enhanced     visualization and precise dissection afforded by the robotic platform, two major     comorbidities affect a significant number of men: incontinence and erectile function.      Urinary continence and erectile function      It is commonly believed that the most important factor affecting continence is preservation     of the external urinary sphincter complex which lies just below the prostate. Trauma to the     urethral tissue itself after it is transected from the prostate and damage to the autonomic     nerves that control this sphincter may lead to sphincteric dysfunction. In addition,     dissection of the bladder may lead to bladder irritability which also plays a role in     incontinence. Surgical removal of the prostate also causes significant inflammatory damage to     the pelvic floor which likely delays recovery of urinary continence. The same trauma issues     apply to sexual function.      One possible method to protect the nerves and other tissues from operative trauma may be the     use of local hypothermia (cold-ischemia) to the pelvis. Local tissue hypothermia using ice,     ice slush, or cold irrigation has been safely and routinely used for decades in humans during     brain, heart, and kidney surgery to minimize organ damage. Yet, this technique has never been     applied to prostate surgery. We will accomplish local cooling of the pelvis using a cooling     balloon inserted into the rectum. The cooling balloon is powered by an FDA approved cooling     system developed by Innercool therapies. Temperatures of 57-86 degrees F (22+/-8 degrees C).      References        1. Khan F, Rodriguez E, Finley DS, Skarecky DW, Ahlering TE. Spread of thermal energy and          heat sinks: implications for nerve-sparing robotic prostatectomy. J Endourol. 2007          Oct;21(10):1195-8.        2. Weld KJ, Koziol S, Montiglio C, Sorenson P, Cespedes RD, Bishoff JT. Feasibility of          laparoscopic renal cooling with near-freezing saline irrigation delivered with a          standard irrigator aspirator. Urology. 2007 Mar;69(3):465-8        3. Gill IS, Abreu SC, Desai MM, Steinberg AP, Ramani AP, Ng C, Banks K, Novick AC, Kaouk          JH.           Laparoscopic ice slush renal hypothermia for partial nephrectomy: the initial          experience.           J Urol. 2003 Jul;170(1):52-6.        4. Wakabayashi Y, Narita M, Kim CJ, Kawakami T, Yoshiki T, Okada Y. Renal hypothermia using          ice slush for retroperitoneal laparoscopic partial nephrectomy. Urology. 2004          Apr;63(4):773-5.        5. Wagner KR, Zuccarello M. Local brain hypothermia for neuroprotection in stroke treatment          and aneurysm repair. Neurol Res. 2005 Apr;27(3):238-45        6. Iwata O, Thornton JS, Sellwood MW, Iwata S, Sakata Y, Noone MA, O'Brien FE, Bainbridge          A, De Vita E, Raivich G, Peebles D, Scaravilli F, Cady EB, Ordidge R, Wyatt JS,          Robertson NJ . Depth of delayed cooling alters neuroprotection pattern after          hypoxia-ischemia. . Ann Neurol. 2005 Jul;58(1):75-87        7. Zhao H, Wang JQ, Shimohata T, Sun G, Yenari MA, Sapolsky RM, Steinberg GK.Conditions of          protection by hypothermia and effects on apoptotic pathways in a rat model of permanent          middle cerebral artery occlusion. J Neurosurg. 2007 Sep;107(3):636-41.        8. Ridenour TR, Warner DS, Todd MM, McAllister AC. Mild hypothermia reduces infarct size          resulting from temporary but not permanent focal ischemia in rats. Stroke. 1992          May;23(5):733-8.        9. Sahuquillo J, Vilalta A. Cooling the injured brain: how does moderate hypothermia          influence the pathophysiology of traumatic brain injury. Curr Pharm Des.          2007;13(22):2310-22   "
233602|NCT00915044|"     The purpose of this study is to examine the effects of different environmental factors on     immune cells in patients with IBD.   "
233703|NCT00906438|"     It is already known from animal studies that the study drug can improve mucosal immunity as     shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an     oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. In     addition, this trial will aim to determine if this intake is able ot improve serum and     salivary IgA synthesis.   "
233603|NCT00915057|"     Little is known about the nature and extent of the disturbance in hepatic function and     biliary hepatic clearance in chronic viral hepatitis, while the course of this disease, the     functional implications and response to treatment are difficult to predict. This study aims     to assess this in patients with chronic viral hepatitis B (CHB) and chronic viral hepatitis C     (CHC) who are eligible for treatment in accordance with the established consensus guidelines     in the involved countries. The pharmacokinetics of NRL972 will be determined at baseline     (within one month of starting treatment), at 3-monthly intervals during treatment, for up to     12 months (or at the end of treatment), and at 3 and 6 months after the end on treatment.     This will provide a clearer understanding regarding the use of the pharmacokinetics of NRL972     in detecting changes in biliary clearance during and after treatment for CHB and CHC.   "
233604|NCT00915070|"     Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance     to changes in perfusion pressure. In the eye, several studies have reported that retinal     blood flow is autoregulated over a wide range of ocular perfusion pressures. The     investigators could recently show that Endothelin-1 is a key metabolite in the regulation of     vascular tone in the eye and plays an important role in the blood flow autoregulation of the     choroidal circulation. However, no data is yet available for the optic nerve head. Thus, the     present study is designed to test the hypothesis that Endothelin-1 plays also a role in optic     nerve head blood flow autoregulation.      Therefore, subjects will perform squatting to increase systemic perfusion pressure during     administration of either an endothelin A-receptor blocker (BQ-123) or placebo. Optic nerve     head blood flow will be continuously measured during the procedure to investigate optic nerve     head autoregulation.   "
233605|NCT00915083|"     The purpose of the study is to determine whether amrubicin is safe and effective in the     treatment of patients with advanced solid tumors. The study will assess the pharmacokinetics     of the amrubicin and if it has an effect on the heart.   "
233606|NCT00915096|"     The purpose of the study is to assess in a prospective series of patients with high tumor     burden follicular lymphoma treated with R-CHOP, the predictive value of [18F]-FDG PET     performed over (after 4 treatments), and at the end of the first-line treatment on     progression-free survival at 2 years.   "
233607|NCT00915109|"     The purpose of this study is to evaluate whether there are quantifiable differences in     walking stability, as measured by the acceleration of the trunk or the variation in step     length, between people with unilateral below-knee amputations from vascular reasons or from     trauma reasons.   "
233608|NCT00915122|"     The purpose of this study is to determine the feasibility and late toxicity of dose escalated     radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the     treatment of high risk prostate cancer. All eligible patients with high risk prostate cancer     who are going to have primary radiation therapy to the pelvic lymph nodes and prostate     seminal vesicles with or without concurrent hormonal therapy will be approached regarding     study entry.   "
233609|NCT00915135|"     The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in     Japanese subjects with Chronic Insomnia   "
233610|NCT00915148|"     This observational study is designed to correlate findings on ultrasound with manual     palpation, and to consider if delivery outcome can be predicted with help of ultrasound.     Specifically, the study will evaluate the significance of fetal head level (descent) in the     pelvis, measured with ultrasound.   "
233611|NCT00915161|"     Collections of fluid around the lung (pleural effusions) are common in patients on mechanical     ventilation. Long stays on mechanical ventilation can lead to serious complications such as     pneumonia and are associated with significant morbidity and mortality. The drainage of     pleural effusions may lead to improvements in oxygenation making it easier to discontinue     mechanical ventilation.      The purpose of this study was to examine the effects of thoracocentesis (pleural fluid     drainage) on blood oxygenation over a 48 hour period to see whether the effects are sustained     and therefore helpful in this discontinuation.   "
233612|NCT00915174|"     Primary:      To assess the effects of repeated dose of Neramexane on the steady-state pharmacokinetics of     Drospirenone [DRSP] and Ethinyl Estradiol [EE]      Secondary:      To assess safety and tolerability of concomitant repeated dose treatments of Neramexane and a     fixed-combinational DRSP- and EE-containing oral contraceptive [OC] (Yasmin®)   "
233613|NCT00915187|"     To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery     system (VaxiSomeTM=CCS-Cholesterol [CCS/C]), combined with commercial influenza vaccine in an     elderly healthy population when given once intramuscularly (IM).   "
233614|NCT00915200|"     The study is designed to test if the combination of two potent antioxidant nutritional     supplements, N-acetylcysteine and the milk thistle extract silibin, is capable of correcting     the shedding of urine protein, the oxidative stress, and the inflammation in patients with     type 2 diabetes mellitus and diabetic kidney disease.   "
233615|NCT00915213|"     The purpose of this study is to discover how often certain bacteria are found in the rectum     at the time of a prostate needle biopsy to diagnose prostate cancer. Certain bacteria are of     importance because they can cause serious infection. Antibiotics that urologists commonly use     to prevent these bacteria from causing infection are no longer effective. Many physicians     around the world are noting increased infections with antibiotic resistant bacteria.     Therefore; despite treating patients who are to undergo prostate biopsy with antibiotics,     certain patients are being readmitted to the hospital with a serious infection. In order to     study the incidence of these particular bacteria, the best method is to culture the bacteria     at the time of the biopsy. This involves one rectal culture swab just prior to needle biopsy     of the prostate. Once the incidence of these bacteria is known we may take steps to prevent     the serious infections that occur as a result of prostate biopsy.   "
233634|NCT00905502|"     The objective of this study is to evaluate the effects of 'high' versus 'low' volume     intraoperative fluid administration (Ringer Lactate, RL) on intra- and postoperative     parameters, in obese patients undergoing laparoscopic bariatric surgery (i.e., gastric     bypass), in order to establish evidence-based data for perioperative fluid management in this     patient population. Based on their experience as well as several reports in the literature,     the investigators hypothesized that a restrictive approach to intraoperative hydration will     reduce the incidence of postoperative complications and the recovery time of gastrointestinal     (GI) function, and shorten hospital stay.   "
233616|NCT00915226|"     Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in     perfusion pressure. The existence of an effective autoregulation in the optic nerve head     (ONH) circulation has been shown in animals and humans. Moderate elevation of intraocular     pressure (IOP) caused only slight effect on ONH blood flow in monkeys, cats and rabbits. In     humans, during an artificial IOP rise using a suction cup method the ONH blood flow maintains     almost constant until IOP reaches 40-55 mmHg. During isometric exercise the upper limit of     autoregulation appears to be approximately 40% above the baseline ocular perfusion pressure.     The mechanism behind ONH blood flow autoregulation is still unknown. The present experiments     are designed to improve the investigators' knowledge of the physiology of regulatory     mechanisms in ONH circulation, which may be helpful for a better understanding of blood flow     abnormalities in glaucoma. This is of importance, because there is an increased evidence,     that vascular dysregulation plays a role in the development of glaucomatous damage.   "
233617|NCT00915239|"     The purpose of this study is to determine whether proton pump inhibitor (PPI) induced     hypersecretion leads to acid related symptoms after treatment in healthy volunteers.   "
233618|NCT00915252|"     The primary purpose of the study is to determine, whether the addition of 5-azacytidine to     standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results     (event free survival).   "
233619|NCT00915265|"     The purpose of this study is to compare the continuous preperitoneal infusion of local     anesthetic and continuous epidural analgesia for postoperative pain management in fast-track     open colorectal surgery.   "
233620|NCT00915278|"     Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main     objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose)     in cancer patients pre treated or unresponsive to standard therapies.   "
233621|NCT00915291|"     The purpose of this study is to determine whether physicians can be educated to better handle     inappropriate requests from patients for direct-to-consumer advertised prescription     medications.   "
233622|NCT00915304|"     The purpose of this study is to analyze the effect of the Evidence-Based Medicine electronic     Decision Support (EBMeDS) automatic reminders in primary health care.      Hypothesis (1)is that in the intervention group the total number of EBMeDS reminders will     decrease compared to the control group.      Hypothesis (2) is that in the intervention group the quality measures will increase faster     compared to the control group at follow-up time.   "
233623|NCT00915317|"     While vitamin D supplementation is safe and effective in repleting vitamin D levels in     dialysis patients, the impact on anemia is unknown. The majority of hemodialysis patients     require erythropoietin supplementation to maintain their serum hemoglobin between 11 and 12     gm/dL, a drug that is both costly and associated with significant side effects. If repletion     of vitamin D significantly decreases erythropoietin requirements in hemodialysis patients, it     would result in a substantial reduction in patient care costs. Our aim is to study the impact     of ergocalciferol supplementation in hemodialysis patients with 25-hydroxyvitamin D     deficiency. The investigators anticipate approximately 30% reduction in erythropoietin dose     requirement in our hemodialysis population.   "
233625|NCT00915343|"     This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase     II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral     modified-release hydrocortisone in comparison to conventional thrice-daily oral     hydrocortisone tablets in patients with adrenal insufficiency   "
233626|NCT00915356|"     This study is being carried out to see which dose of AZD1305 is safe and effective in     cardioverting atrial fibrillation into normal heart rhythm.   "
233627|NCT00915369|"     This study is a multicentre, open label, non-randomized phase I study. The main objectives of     the study are to determine the pharmacokinetic profile of the drug at different dose levels     in the patients with Advanced Breast Cancer. Maximum Tolerated Dose (MTD) and safety of     Paclitaxel Nanoparticle will also be simultaneously assessed.   "
233628|NCT00915382|"     The urgent need for a new effective therapy with better safety profile for the metastatic     gastric cancer patients and promising results observed so far in the studies with S-1 plus     cisplatin combination in advanced gastric cancer (AGC) strongly warrants the comparison of a     3-weekly schedule to a 5-weekly schedule of S-1 plus cisplatin as a standard regimen in the     first-line treatment for AGC patients.      The objectives of this study are to compare a 3-weekly schedule to a 5-weekly schedule of S-1     plus Cisplatin combination in terms of efficacy, quality of life and safety in patients with     previously untreated advanced or recurrent unresectable gastric cancer. Primary endpoint is     progression-free survival. This is an open label, randomized, multi-center,     non-inferiority/superiority (of 3-weekly regimen over 3-weekly regimen) hybrid study.   "
233629|NCT00915408|"     The purpose of this study is to determine the maximum tolerated dose (MTD) and to evaluate     the safety of cyclophosphamide when given on days 1 and 8 in a 28 day cycle in doses starting     at 300mg ranging to 700mg in combination with Lenalidomide (Revlimid®) plus dexamethasone in     patients who present with relapsed or refractory myeloma.   "
233630|NCT00915421|"     Type of study: Pilot prospective nonrandomized feasibility clinical study.      Aim of the study: To assess the feasibility of pre-hospital therapeutic mild hypothermia in     patients successfully resuscitated from out-of-hospital cardiac arrest in the setting of     prehospital and hospital care in Czech republic.      Evaluated hypothesis: Pre-hospital initiation of therapeutic mild hypothermia by rapid     administration of intravenous bolus of cold crystalloids is simple, safe, effective and is a     feasible procedure to significantly decrease body core temperature during patient's transport     to the hospital in Czech republic.      The study is observational and does not evaluate any new drug, therapeutic procedure or     diagnostic procedure. It is evaluating a known therapeutic procedure, therapeutic mild     hypothermia, induced by known technique, cold crystalloid infusion, widely accepted in     hospital-related postresuscitative care. However, even its prehospital usage has been     published.   "
233631|NCT00915434|"     This is an open-label (both the physician and healthy volunteer know which treatment will be     administered), single-dose, 4-period study to characterize the pharmacokinetics (process by     which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) and     effect of food on the pharmacokinetics of JNJ-31001074. The study consists of three phases: a     screening phase to determine eligibility, an open-label 4-period treatment phase and an     end-of-study/early withdrawal assessment phase.   "
233636|NCT00905528|"     Basal nitric oxide (NO) activity plays a pivotal role in the regulation of glomerular     hemodynamics, and in animal experiments its alteration has been associated with morphological     changes characteristic of diabetic nephropathy. The investigators aimed to assess in a     prospective study: 1. basal NO activity of renal vasculature and 2. renal hemodynamics to     examine whether impairment of basal NO activity of the renal vasculature is related to     development and progression of diabetic nephropathy and other cardiovascular endpoints.   "
233637|NCT00905541|"     3-Hydroxy-3-methylglutaryl coenzyme A-reductase inhibitors (statins) decrease apolipoprotein     B-100-containing lipoproteins by increasing their fractional catabolic rates through     low-density lipoproteins (LDL) receptor-mediated uptake. Their influence on hepatic secretion     of these lipoproteins is controversial. The current study investigates whether simvastatin     influences lipoprotein secretion.   "
233638|NCT00905554|"     Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of     drug-related side effects, although it may be painful for the patient. Based on recent     reports, the investigators designed this randomized controlled trial hypothesizing that the     use of water irrigation versus air insufflation during the insertion phase of colonoscopy     might increase the global tolerability of the examination and the proportion of patients     undergoing complete colonoscopy without sedation.   "
233639|NCT00905567|"     The objective of this study was to compare the rate and extent of absorption of topiramate 25     mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fed     conditions.   "
233677|NCT00906087|"     The purpose of this study is to determine if one of the genes that can cause glaucoma, called     myocilin, are associated with larger eye pressure and blood pressure changes in sitting and     lying down positions without glaucoma drug treatment and with glaucoma drug treatment with a     combination medication called Cosopt® (Merck & Co., Inc.).   "
233640|NCT00905580|"     The investigators hypothesize that pregabalin will decrease post-operative pain scores and     analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The     primary outcome will be acute postoperative pain, measured by a verbal numerical rating score     (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome     will be the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months     after operation.   "
233641|NCT00905593|"     Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of     nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico,     which means all ongoing patients participating on [CAMN107A2109] excluding discontinued     patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg     b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have     a maximum of 24 months of follow-up time.   "
233642|NCT00905606|"     The objective of this study was to compare the rate and extent of absorption of topiramate 25     mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fasting     conditions.   "
233643|NCT00905619|"     An increasing number of Veterans are anticipated to develop chronic kidney disease (CKD) and     require hemodialysis (HD) treatments as the Veteran population ages. In 2003, approximately     290,000 US citizens were receiving HD and an estimated 19 million were affected by CKD. The     annual growth rate is predicted to be 7% per year with 500,000 Americans receiving HD     treatment by 2010. In 2005, approximately 2500 Veterans were receiving HD with growth     expected to parallel that seen in the general population. Whereas Alzheimer's disease is the     leading cause of dementia in the general population, growing evidence suggests that patients     with advanced CKD experience cognitive deficits related to accelerated cerebrovascular     disease. Patients with advanced CKD have been shown to have a high prevalence of sub-clinical     cerebrovascular damage on imaging studies and a heavy burden of vascular risk factors such as     diabetes, elevated cholesterol, and hypertension. Many of the cognitive deficits related to     cerebrovascular disease may go unrecognized by routine measures of cognition. HD patients     have increased number of hospitalizations, and several compliance issues ranging from     congestive heart failure to dangerous electrolyte imbalances. Impaired cognition in this     population is likely to have a significant impact on self-care and compliance with complex     medical regimens. Currently, the severity and scope of cognitive impairment related to     vascular disease is not well known in patients with advanced kidney disease. Additionally,     the relationship between cognitive impairment and measures of self-care independence are not     well known. Loss of independence and function secondary to impaired cognitive function is     likely to be a significant problem for patients with advanced kidney disease. Early     identification of functional impairment, particularly instrumental activities of daily living     (IADL), will allow for rehabilitation intervention. Maintaining or improving functional     independence through intensive rehabilitation could translate into better compliance and     lower hospitalization rate among HD patients. Information obtained from this study is likely     to heighten awareness of cognitive impairment and the functional consequences in Veterans     with advanced kidney disease. Primary objectives are to determine:        1. The range of cognitive deficits with emphasis on domains affected by vascular disease in          patients with advanced CKD and those receiving hemodialysis.        2. The associations between severity of cognitive impairment and severity of kidney          disease.        3. The prevalence of impaired IADLs and the level of health-related quality of life (HRQOL)          in patients with advanced CKD and those requiring hemodialysis.        4. The relationship or association of cognitive impairment with IADL and HRQOL.      Secondary objective is to determine:      1. The relationships among cerebral and carotid blood flow, carotid artery stiffness, and     renal specific metabolic abnormalities with cognitive impairment.   "
233644|NCT00905632|"     The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week     combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C     virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected     patients.   "
233645|NCT00905645|"     Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary     augmentation, primary reconstruction, and/or revision of the female breast.   "
233646|NCT00905658|"     RATIONALE: Learning about the effect of nutritional supplements on quality of life in     patients receiving chemotherapy for cancer may help doctors plan the best treatment.      PURPOSE: This randomized phase II trial is studying nutritional supplements to see how well     they work in improving quality of life during first-line chemotherapy in patients with     metastatic gynecologic cancer.   "
233647|NCT00905671|"     This pilot study is going to examine the hypothesis that in coronary arteries, soft lesions     that contain lipid cores, but are not calcified or fibrotic and are located in proximity to     side branches, are associated with side branch compromise as a result of plaque shift during     angioplasty and stenting. Plaque characteristics will be detected by intravascular near     infrared spectroscopy (NIRS).   "
233648|NCT00905684|"     This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000     patients in European countries and countries in Middle East who are newly prescribed any     available OC. Patients will be followed up approximately 6 months after initial visit.     Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin     or any other OC has been made. Physicians should consult the full prescribing information for     the respective OC before enrolling patients and familiarize themselves with the safety     information in the product package label.   "
233649|NCT00905697|"     The purpose of the present study is to investigate how the health of donors in living donor     lung transplantation will change after transplant operations.   "
233650|NCT00905710|"     Lynch syndrome (LS), or hereditary nonpolyposis colorectal cancer (HNPCC), is a hereditary     disorder predisposing for colorectal cancer. To reduce the risk of colorectal cancer,     patients undergo colonoscopy every 1-2 years. Chromoendoscopy is relatively new technique     which improves the detection of adenomas, the precursor lesions of colorectal cancer. The aim     of this study is to determine whether chromoendoscopy, including polypectomy of all detected     lesions, reduces the development of colorectal neoplasia and the need for colectomy in LS     patients.   "
233651|NCT00905723|"     Climacterium is marked by hypoestrogenism and it is associated to drastic vasomotors     symptoms, genital atrophy and humor alteration. Additionally, these symptoms impair sexual     life and life quality. These effects can be counteracted by administration of estrogen     therapy. However, estrogen therapy has side effects and isoflavone has been proposed as an     estrogen substitute in reposition therapy. The aim of the randomized controlled trial is to     evaluate the effects of isoflavone in the sex life assessed by a modified McCoy's sexual     questionnaire.   "
233674|NCT00906048|"     The primary objective is: to assess the microbiological success of the combination of     levofloxacin and rifampicin, administered for 32 to 37 days, as oral replacement therapy of     an empirical antibiotic therapy of a maximum of 5 to 10 days given intravenously, in the     treatment of OsteoArticular Prosthetic Infections (OAPI), with a two-stage revision of the     prosthesis.      The secondary endpoints are:        -  To assess the rate of clinical failure 12 months after the reimplantation of the          prosthesis.        -  To assess the joint mobility function score 12 months after the reimplantation of the          prosthesis.        -  To assess the safety of the combination of levofloxacin and rifampicin.        -  To investigate prognostic factors for success after the end of treatment and at 12          months after the reimplantation of the prosthesis.   "
233652|NCT00905736|"     Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain     and disability. Treatment of the disorder is not always successful, and it often recurs or     becomes chronic. More effective management options are required. There is evidence that     electric microcurrent can promote tissue healing and symptom resolution in various chronic     hard and soft tissue disorders, but few human studies have investigated its use with chronic     tendon problems. It is an easily applied therapy with very few reports of side effects. It     can be applied at home using a portable unit and, if it is clinically effective, may also     prove more cost effective than other therapies.      A clinical trial is planned to evaluate the therapy but, in the absence of relevant published     evidence, a preliminary study is required to look for a treatment effect and inform a power     calculation for sample size, The study is comparing the effects of two different forms of     microcurrent treatment.   "
233653|NCT00905762|"     The purpose of this study is to assess the concentration of besifloxacin compared to     gatifloxacin and moxifloxacin in human conjunctival tissue, following a single drop of the     drug instilled topically into the study eye. Conjunctival biopsies will be performed at     specified time points, followed by the use of loteprednol etabonate/tobramycin ophthalmic     suspension four times a day for 5 days.   "
233654|NCT00905775|"     Acute renal insufficiency (ARI) represents a frequent and serious complication in patients     submitted to cardiac surgery, and is associated with increases in time of hospitalization,     costs, morbidity and mortality. Its incidence varies from 3.5% to 31%. The present study aims     to evaluate renal function and oxidative stress in patients submitted to revascularization     surgery with extracorporeal circulation (ECC), comparing targeted venous anesthesia     controlled with propofol and inhalational anesthesia with isoflurane.   "
233655|NCT00905788|"     According to the studies, about 80% of patients undergoing in vitro     fertilization/intracytoplasmic sperm injection (IVF/ICSI) reach to the embryo transfer     process, but only a few of them become pregnant.      The cause of this difference can be due to some factors such as the endometrial receptivity,     quality of transferred embryos and embryo transfer technique. Retained or expelled embryo(s)     following embryo transfer is (are) one of the factors which may be effective on outcome. The     purpose of this randomized clinical trial study is Lowering embryo expulsion following     embryo transfer to improve outcome.   "
233656|NCT00905801|"     This is an experimental study of the feasibility and efficacy of CT perfusion (CTP) imaging     (CT blood flow measurements) in subjects with non-small cell lung cancer.   "
233657|NCT00905814|"     The hypothesis of this study is that one 5 mg tablet of axitinib has similar drug     concentrations in plasma compared to five 1 mg tablets of axitinib after oral dosing.   "
233658|NCT00905827|"     Suicide prevention among military Veterans has become a national priority; yet, there is a     gap in suicide-specific intervention training for mental health students and professionals.     The need for training in this area has become even more acute with the recent hiring by the     Veterans Health Affairs (VHA) of thousands of clinicians to address the mental health needs     of Veterans from all war eras. Since e-learning (online) education is more effective than     traditional in-person (face-to-face) education for adult learners when methods, such as     blended learning, are used, this mode of delivery may more easily meet the training and     continuing education needs of busy medical professionals who may find it easier to fit online     education into their daily schedules.      A well developed in-person training approach known as the Collaborative Assessment and     Management of Suicidality (or CAMS) has been recommended in systematic reviews as an     effective tool for assessing and managing suicidality, as well as decreasing providers'     fears, improving their attitudes, increasing their knowledge, confidence, and competence, and     dispelling myths. The overall aims of this project were to develop an e-learning alternative     for the CAMS program, determine its effectiveness relative to in-person CAMS training, and     assess factors that may relate to adoption and implementation of CAMS in general and     specifically through e-learning and in-person modalities.   "
233659|NCT00905840|"     The purpose of this study is to assess the change of crestal bone level at the Titanium     Zirconium (TiZr) compared to Titanium (grade IV) implant between surgery and 6, 12, 24, and     36 month post surgery.   "
233660|NCT00905853|"     This study will compare aggressive antiarrhythmic therapy to catheter ablation for     ventricular tachycardia in patients who have suffered prior myocardial infarction. The     purpose of this study is to evaluate the optimal management of patients presenting with     recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy.     The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for     recurrent VT.   "
233661|NCT00905866|"     There are three specific aims in the present study:        1. To validate the investigators' translated version of parathyroidectomy assessment of          symptoms (PAS) questionnaire.        2. To evaluate the impact of parathyroidectomy on health-related quality of life in the          investigators' patients with hyperparathyroidism.        3. To analyze the association between clinical variables and the presentation/severity of          symptoms (and/or quality of life domains) in the investigators' patients.   "
233662|NCT00905879|"     Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and     tolerability will be assessed.   "
233663|NCT00905892|"     The purpose of this study is to determine the partitioning of exogenous lipids in the     postprandial period while a study of overfeeding. The method is based on the incorporation of     a stable isotopic tracer (d31_palmitic acid, d31_C16) in lipoprotein triglycerides     (TG-CHYLOMICRON and TG-VLDL) and in free fatty acids (FFA).   "
233675|NCT00906061|"     There is little information of Eastern Cooperative Oncology Group (ECOG) performance status     (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into     Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.      This low rate makes the investigators think about the possibility of a bias selection, due to     the existence of this exclusion criteria that do not permit to include patients with     deteriorated performance status.      In these types of patients, the toxicity is an important issue to decide the therapeutic     strategy. Gemcitabine and Docetaxel combination is very interesting because they have a     different toxicity profile. This combination has demonstrated activity in several types of     tumours, as breast cancer, sarcoma and lung cancer.      The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel;     activity and dose intensity will be the same, but toxicity will be significantly low.   "
233664|NCT00905905|"     During acute coronary syndromes (ACS), the generation of inflammatory mediators negatively     influences arterial wall remodeling and the endothelium-dependent vasomotor function in the     coronary and systemic arterial systems. In fact, the intensity of the inflammatory     upregulation is strongly related to the incidence of recurrent coronary events. The     investigators previously demonstrated that high dose potent statins can rapidly reduce plasma     levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS. In     addition, such statin treatment attenuates the post-discharge endothelial dysfunction of     these patients. By inference, it is plausible to hypothesize that these beneficial effects     during ACS may be intensified by an additive lowering of plasma cholesterol through the     treatment with ezetimibe. So far, data is unavailable to verify this assumption. In parallel,     data from animal models have suggested that both statins and ezetimibe may reduce insulin     sensitivity by their effect on cholesterol content and, by this way, on insulin signaling in     liver cells. In this context, the present study aims to investigate the role of the addition     of ezetimibe upon statin treatment on stress-induced insulin resistance and on the     time-course of the inflammatory response during the acute phase of myocardial infarction and     its late effect on endothelium-dependent arterial dilation.   "
233665|NCT00905918|"     RATIONALE: Vitamin E may help prevent the development of cancer. Studying samples of tissue     from patients with colorectal cancer who receive Vitamin E before undergoing surgery in the     laboratory may help doctors learn more about how Vitamin E changes biomarkers related to     colorectal cancer.      PURPOSE: This randomized early phase I trial is studying giving vitamin E supplements to see     how it affects biomarkers in patients undergoing surgery for colorectal cancer.   "
233666|NCT00905931|"     In this study the investigators wish to explore the potential neuroprotective effects of     acute oral supplementation of lycopene, a natural anti-oxidant derived from tomatoes, on     cerebral vasospasm and autoregulation, and examine whether any improvements translate into a     reduction of biochemical markers of vascular injury and inflammation a decrease in the     prevalence of secondary strokes following subarachnoid haemorrhage.   "
233667|NCT00905944|"     The investigators will evaluate the effects of an exercise program (walking on a treadmill)     on the physical performance, the cardiorespiratory function, the proclivity to heart     arrhythmias and the quality of life of patients with severely impaired left ventricular     function and a bi-ventricular resynchronization pacemaker.   "
233668|NCT00905957|"     The purpose of this study is to evaluate the efficacy of a local anaesthetic injection in the     plane between the abdominal muscles in reducing the amount of pain relief required after     surgery.   "
233669|NCT00905970|"     It is traditionally considered that the development of Latent Tuberculosis Infection (LTBI)     is due to the M. tuberculosis ability to develop a dormancy state within well-structured     lesions (granulomas), which can remain in the lung of the host even for life. A new original     hypothesis has been developed in the Experimental Tuberculosis Unit based on scientific     evidence that take into account the idea that a lesion cannot be held forever, because the     host tends to remove any lesion in order to rebuild the original parenchyma, in a healing     process. Even if M. tuberculosis can remain in a dormant/non-replicating state for a long     period, this is an important but not sufficient factor to explain the LTBI. The Dynamic     Hypothesis tries to explain the existence of LTBI in spite of the healing process that could     remove it by a constant reinfection of the host's tissue. While the Static view defends the     induction of active TB after the reactivation of the bacilli from and old lesion; while the     Dynamic view wants to demonstrate that there is a constant induction of new granulomas. In     case one of these new lesions takes place in the upper lobe privileged zone, the possibility     to induce a cavity would appear, developing an active Tuberculosis (TB).   "
233670|NCT00905983|"     Lung cancer is one of the most common malignancies worldwide and the leading cause of     cancer-related deaths in Western countries. Standard treatment for patients with good     performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based     chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to     platinum related toxicities. Several drugs with novel mechanisms of action and significant     activity in NSCLC have been developed; including docetaxel and gemcitabine that are also     active in patients previously treated with cisplatin-based regimens and have a more favorable     toxicity profile. The more favorable toxicity profile of docetaxel and gemcitabine supports     its use as first-line chemotherapy, especially in patients with severe comorbidities as     elderly patients. To improve the therapeutic index of this combination, the investigators     performed a study with biweekly gemcitabine and docetaxel in elderly patients.   "
233671|NCT00905996|"     In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection     will be better than both beta-blocker therapy and no treatment in prevention of gastric     variceal bleed. The investigators conducted a randomized controlled trial in patients with     gastric varix (GOV2 and IGV1) who never bled before, to study the efficacy of treatment with     cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed     from gastric varices.   "
233672|NCT00906022|"     The clinical investigation is a prospective, international, multi-centre, randomized (1:1)     trial with follow up investigations at 1, 3, 6 and 12 months. Patients will be randomized     either to treatment with stenting with the Astron Pulsar SE (4 or 5 mm diameter) stent or to     PTA with optional bailout stenting in case of PTA failure.      The primary objective of this study is to show clinical improvement in the outcome of     patients with symptomatic critical limb ischemia or severe intermittent claudication     (Rutherford 3, 4, 5) treated with the Astron Pulsar SE (4 or 5 mm diameter) in comparison     with PTA or optional bailout stenting in case of PTA failure.   "
233673|NCT00906035|"     This research study will evaluate the effects of aspirin and dipyridamole alone and in     combination on the blood flow in the vessels of the legs. We will examine how these     medications are able to inhibit the clotting of platelets in the vessels of patients with     PAD, and thereby affect the blood flow in the legs. Platelets are cells in the blood that     have the ability to adhere to each other to form clots.   "
233676|NCT00906074|"     This is an observational study to evaluate the relative importance of the known risk factors     for severe surgical site infections (SSIs) on the development of the more severe SSI cases,     and to describe the demographic, clinical features, etiology and the management and outcome     of patients suffering from severe SSIs in Spain.   "
233678|NCT00906100|"     The purpose of this study is to determine the proportion of patients who are undergoing     Biventricular (BiV) Implantable Cardioverter Defibrillator (ICD) implantation in whom     optimization of atrioventricular (AV) delay is not possible due to prolonged     inter-atrial/intra-atrial delay. These patients would benefit from left atrial pacing, and if     a significant number of patients fall into this group, it may be beneficial to develop a left     atrial lead.   "
233679|NCT00906113|"     Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for     retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye     such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child     with retinoblastoma will have active cancer in a single remaining eye with useful vision. In     such cases, it is sometimes necessary to remove this eye. In such cases, the injection of     chemotherapy directly into the artery that supplies the eye and the tumor may lead to     regression of the tumor without the need to remove the eye.      This form of treatment was pioneered by a group in New York (Abramson et al). In this study     the investigators will assess the efficacy and safety of the technique in a group of children     with retinoblastoma.   "
233680|NCT00906126|"     A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment     labor in nulliparous women diagnosed with arrest of dilation.   "
233681|NCT00906139|"     The purpose of this study is to compare propofol associated with fentanyl versus midazolam     plus fentanyl for sedation during diagnosis or therapeutic upper gastrointestinal endoscopy     (UGE) in cirrhotic patients.   "
233682|NCT00906152|"     A prospective study to assess the association between the change in quality of sleep and the     change in intensity of pain in Spanish patients seen for subacute or chronic low back pain.     The objective is to determine the prevalence of sleep alterations, the association between     quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing     and depression.   "
233683|NCT00906165|"     The study is designed to evaluate the clinical and radiographic outcomes of Straumann® Bone     Level Implant SLActive placed in healed alveolar ridge (at least 8 weeks post extraction) and     immediately provisionalised versus the same type of implants placed in healed alveolar ridge     but not provisionalised. In both cases the implants will be loaded at 16 weeks (final     restorations). The outcomes will be evaluated over a 2-year period.   "
233684|NCT00906178|"     The investigators propose to design and test an Internet-based HIV prevention program for     adolescents in Uganda.   "
233685|NCT00906191|"     The objective of this study is to investigate how quickly and to what extent the 14-Carbon     labeled SAM-531 is absorbed into the bloodstream, converted and eliminated from the body     after oral administration in healthy male subjects. As 14-Carbon labeled SAM-531 is     radioactive, this enables the compound to be traced in blood, urine and feces.   "
233686|NCT00906204|"     In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence     was found that a single large dose of Thymoglobulin on the day of kidney transplantation     produced better kidney function than the standard dosing plan, when the same amount is     divided into smaller doses on 4 days. This new study repeats that dose comparison, but with     double-blinding and at multiple transplantation centers.   "
233687|NCT00906217|"     This study aims to further define the appropriate population for Pico-Salax, a purgative used     prior to colonoscopy. Patients over the age of 70 years with normal renal function scheduled     for colonoscopy will receive Pico-Salax and have pre and post preparation bloodwork and     electrocardiograms (ECGs).   "
233688|NCT00906243|"     This is a Phase I/IIa open, uncontrolled, prospective study, to be conducted in an     out-patient setting. The present study is one of two clinical trials of the RNActive®-derived     vaccine CV9103 being conducted concurrently in the US and Europe, which represent the first     clinical trials conducted for this novel vaccine.      The Phase I part of the study consists of a staggered inclusion of subjects in two cohorts of     3, to confirm the safety of the intended dose (320 µg RNA per antigen), with a lower dose to     be considered in case of dose-limiting toxicity (DLT) being reported in greater than or equal     to 2 out of 3-6 subjects; in this way, the recommended dose (RD) for the Phase IIa part of     the study will be established. In the Phase IIa part of the study, additional subjects will     be included at the RD, to confirm the safety and explore the activity of that dose.   "
233689|NCT00906256|"     The purpose of this study is to determine the pharmacokinetic profile of oral doses of     AZD7295 capsules in healthy subjects, and also to assess the effects of food as well as     safety and tolerability.   "
233691|NCT00906282|"     The purpose of this multi-center Phase II trial is to examine the impact of     pemetrexed/carboplatin in the preoperative treatment of patients with select stage IB, II,and     III non-squamous NSCLC. Because patients with non-squamous type NSCLC have been shown to have     better survival rates than patients with squamous tumors when given pemetrexed with a     platinum agent, only patients with non-squamous NSCLC (adenocarcinoma, large cell, and     undifferentiated), not including squamous histology, will be allowed to participate in this     study. If this novel regimen proves to be safe and active in this setting, it will provide     rationale for further investigation in a larger, prospective, randomized trial.   "
233692|NCT00906295|"     The purpose of this study is to determine whether a higher threshold for transfusion with red     blood cells improves the postoperative ambulation.   "
233693|NCT00906308|"     This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency     of moderate to severe hot flushes in postmenopausal women.   "
233707|NCT00906503|"     RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before     and after steroid therapy may help doctors assess a patient's response to treatment and help     plan the best treatment.      PURPOSE: This phase I trial is studying fludeoxyglucose F 18 PET scan performed before and     after ultra short-term dexamethasone therapy to see how well it measures changes in nodules     in patients with lung nodules.   "
236427|NCT00952796|"     On the basis of monotherapy for intra-abdominal infection, the investigators are conducting     this study to identify the difference of drug efficacy between ampicillin/sulbactam and     moxifloxacin.   "
233694|NCT00906321|"     Background:        -  Chemoprevention is the use of preventive medications to reduce the risk of breast cancer          for women who are at a high risk of developing the disease. Although the treatment has          shown effectiveness in preventing cancer development, chemoprevention is notably          underutilized even by women who are at a high risk of developing breast cancer.        -  Researchers are interested in determining if better decision support mechanisms, such as          interactive Web sites, can help to overcome some of the barriers to chemoprevention.      Objectives:      - To develop and test a prototype Web-based module that will provide decision support to     women who are considering chemoprevention for breast cancer.      Eligibility:        -  Women 35 years of age and older who are at high risk for breast cancer and whose doctor          has recommended chemoprevention (either Tamoxifen or Raloxifene), and who have no other          history of cancer (apart from non-melanoma skin cancer or precancerous cervical          lesions).        -  Participants must have a working e-mail address and access to a computer with internet          access and a telephone.      Design:        -  Participants who are considering chemoprevention will be randomized to a Web-based          decision support module or standard care online information resources.        -  Participation lasts two months and involves using the online resources provided and          filling out questionnaires two times during the study (at the beginning and the end).      The first time will be at the begin of the study.        -  No medical treatments are offered as a part of this study   "
233695|NCT00906334|"     This study will explore the efficacy and safety of a regimen of ON 01910.Na as a 48-hour     continuous intravenous infusion once a week for 3 weeks of a 4-week cycle in MDS patients     with Trisomy 8 or classified as Intermediate-1, -2 or High Risk who are not responding to     current therapeutic options. The rationale for this trial is based upon data from laboratory     studies with ON 01910.Na and upon activity that has been observed in other clinical trials     with ON 01910.Na in patients with MDS.   "
233696|NCT00906347|"     This is a prospective, randomized, controlled trial designed to examine the efficacy of oral     misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.   "
233697|NCT00906360|"     This phase I trial is studying the side effects and best dose of sunitinib when given     together with cetuximab and radiation therapy in treating patients with locally advanced or     recurrent squamous cell carcinoma of the head and neck. Sunitinib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow     to the tumor. Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving sunitinib together with cetuximab and radiation therapy     may kill more tumor cells.   "
233698|NCT00906373|"     To determine if IMC-A12 given in combination with Sorafenib is safe and effective for     patients with advanced liver cancer.   "
233699|NCT00906386|"     The main hypotheses guiding the study are:        1. Stable methadone maintenance patients receiving varenicline will be more likely to          maintain abstinence than patients receiving placebo        2. There will be no differences in the type and number of symptoms reported between stable          methadone maintenance patients receiving varenicline and placebo        3. There will be no changes in methadone dosage between abstinent and non-abstinent smokers        4. There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline          between male and female participants   "
233700|NCT00906399|"     The primary objective of this study is to determine the efficacy of peginterferon beta-1a in     reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis     (RMS) at 1 year. The secondary objectives of this study are to determine whether     peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the     total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance     imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the     progression of disability.   "
233701|NCT00906412|"     This is part of a larger study for which participants have already completed memory and     thinking tests. In this study, investigators are trying to learn how deep-brain stimulation     affects memory skills in essential tremor (ET) patients. We are especially trying to figure     out how stimulation on each side of the brain may affect working memory.   "
233702|NCT00906425|"     The purpose of this study is To demonstrate that there is no difference in change in bone     level around P.004 implants between 1st stage surgery and 6 months post surgery when     transmucosal implant placement is compared to submerged implant placement   "
233899|NCT00919477|"     To gather information on the safety of monotherapy of Casodex® tablets 80 mg, targeting     prostate cancer patients who have no history of having received treatment by either endocrine     therapy (including surgical castration).   "
233704|NCT00906451|"     During myocardial infarction, inflammatory response may negatively influence ventricle wall     remodeling as well as endothelium-dependent vasomotor function in the coronary and systemic     arterial systems. Statins have been consistently proved to attenuate inflammation and improve     endothelial function. In this study, we tested the effect of different doses of statin on     inflammatory response and endothelium-dependent vasodilation.   "
233705|NCT00906477|"     The purpose of this study is to determine whether modified CI therapy treatment is suitable     and effective in the early rehabilitation after stroke, and to compare early CI intervention     with a later CI intervention group.   "
233706|NCT00906490|"     The primary objective of this study is to evaluate the performance and safety of the     intravenous blood glucose (IVBG) System relative to point of care (POC) meter performance     when each method is compared to the Yellow Springs Instrument (YSI) under various conditions     in the operating room (OR), ICU and general ward (GW) in subjects undergoing elective or     non-emergent surgery as well as subjects admitted to the medical/surgical ICU. POC meter     systems are currently used in the hospital environment to measure blood glucose values. The     YSI is an accepted reference standard for assessing POC meter accuracy.      The secondary objective of this study is to evaluate the performance of the IVBG System as     compared with the YSI under various conditions in the operating room (OR), intensive care     unit (ICU) and general ward (GW) in subjects undergoing elective or non-emergent surgery as     well as subjects admitted to the medical/surgical ICU.   "
233708|NCT00906516|"     Bradmer Pharmaceuticals, Inc. (Bradmer) is requesting approval to study the safety of     Neuradiab® when combined with Bevacizumab (Avastin) therapy given at a minimum of 30 days     after Neuradiab administration in patients with a first or second recurrence of glioblastoma     multiforme (GBM), in an attempt to manage life threatening recurrence of Grade IV malignant     glioma.   "
233709|NCT00906529|"     The purpose of this study is to determine whether aggressive (goal pre-prandial blood glucose     <110 mg/dl) versus conservative (goal pre-prandial blood glucose <180mg/dl) diabetes     treatment of type 2 diabetic patients on the general medical wards has any effect on hospital     outcomes.   "
233710|NCT00906542|"     Pneumonia is a frequent complication of acute stroke and is associated with increased     mortality and long-term impairment in the affected subjects. In previous studies, a number of     clinical (e.g., dysphagia, severe neurological impairment, mechanical ventilation),     radiological (e.g., large infarctions in the territory of middle cerebral artery, insular     infarction) and biochemical (e.g., increased serum levels of C-reactive protein, decreased     levels of CD4+ T-lymphocytes) findings have been reported as risk factors of stroke-related     chest infection. The present study (PRECAST) aims to identify a small set out of these     previously described risk factors that can predict stroke-related pneumonia with high     sensitivity and specificity.   "
233711|NCT00906555|"     Adequacy of solute clearance makes a profound impact on clinical outcome in maintenance     hemodialysis patients. Thus far, guidelines on the target of solute clearance (Kt/V or URR)     are based on patients with three dialysis sessions per week. However, quite a few patients     have their dialysis sessions twice per week in China. The dialysis target of solute clearance     in this population remains to be elucidated. The aim of this study was to explore the optimum     target solute clearance (Kt/V or URR) in maintenance hemodialysis patients with two dialysis     sessions per week. Two groups of hemodialysis patients with different Kt/V (1.2 ≤ Kt/V ＜ 1.7     versus Kt/V ≥ 1.7) will be followed until 96 weeks in this prospective, randomized,     multi-center, interventional study.   "
233712|NCT00906568|"     Chronic bronchial inflammation is an important clinical feature in cystic fibrosis.     Approximately 10% of patients with cystic fibrosis suffer from Allergic Bronchopulmonary     Aspergillosis. In addition airway inflammation in patients with cystic fibrosis (CF) plays a     major role in progression of CF lung disease. In patients with mild disease (Vital capacity     >75%) airway inflammation is often under diagnosed.      Severity of allergy against Aspergillus fumigatus will be examined using radioallergosorbent     test and skin Prick-test. Subsequently, in patients with established sensitization (RAST ≥     0.35 IU/mL) a specific bronchial provocation with Aspergillus will be performed. In addition,     exhaled nitric oxide,carbon monoxide, exhaled air temperature and inflammatory cells in     sputum is measured. 24 hours after bronchial allergen provocation, exhaled NO, CO, air     temperature, and bronchial responsiveness is determined and a second sputum obtained.      This study is designed to characterize patients with CF and sensitization against Aspergillus     fumigatus in an early stage to prevent pulmonary complications of ABPA. In addition sputum     cytokine profiles in CF patients with mild and moderate disease may be different in patients     without and with involvement of small airway disease (SAD).   "
233713|NCT00906581|"     Use of a computer-based treatment will reduce level of depression.   "
233714|NCT00906594|"     The purpose of this study is to evaluate the additive effect of dorzolamide/timolol fixed     combination in patients undergoing monotherapy with latanoprost.   "
233715|NCT00906607|"     Introduction: Urinary incontinence (UI) is considered erroneously by many as being a     phenomenon of the aging process, however there is a growing prevalence of complaints of UI in     nulliparous and nulligest young women.      Objective: To investigate the prevalence of urinary incontinence in women of different age     groups.      Method: 78 nulliparous and nulligest women of different resident age groups in the city of     France, being these divided in: G1 (10-18 years); G2 (20-35 years); G3 (45-60 years) and G4     (65-75 years). Excluded from this study were women with cancer or surgeries of the inferior     urinary treatment, urinary infection, alterations cognitive, pregnant and obesity. All the     participants were questioned as a perception of urine loss, to the efforts or effortlessly     evident.   "
233716|NCT00906620|"     SEYLE is a health promoting program for adolescents in European schools. Its main objectives     are to lead adolescents to better health through decreased risk-taking and suicidal     behaviors, to evaluate outcomes of different preventive programs and to recommend effective     culturally adjusted models for promoting health of adolescents in different European     countries. Because of the significance of the SEYLE program and the importance of suicide     research, Israel is honored to take part in this program and be a collaborator in it's     implementation and research.   "
233717|NCT00906633|"     This trial is an observational study about combination antifungal therapy in hematologic     patients with proven and probable invasive fungal infections (IFI).   "
233721|NCT00906685|"     Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no     treatment has been available to improve visual acuity. The present study intends to     investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated     control patients.   "
233722|NCT00906698|"     To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of     oral BIBW 2992 in combination with intravenous or oral vinorelbine   "
233745|NCT00907023|"     The aim of this study is to determine the influences of discharge teaching and care     coordination on how ready a parent is to take their child home from the hospital after a     solid organ (kidney, heart and liver) transplant. This study will also look into how the     parent handles coping, utilization of healthcare resources, and parent adjustment 3 weeks     after discharge from the hospital.   "
233723|NCT00906711|"     Introduction: While growing older, it is possible to notice a decrease in the functional and     physiological reserves in the organism which impairs the the abilities in the elderly in     doing some tasks. A simple balance becomes a challenge.      Objective: To evaluate the functional balance in the aging process.      Methods: The group was formed by 48 people from 10 to 85 years old. The evaluation     instruments are the Berg Balance Scale (BBS), the Performance Oriented Mobility Assessment     (POMA), the Unipodal Support Test, the Functional Reach Test and the Romberg's Test.   "
233724|NCT00906724|"     Hypothesis: Insulin-resistant African-American and Hispanic adolescents will show significant     improvement of insulin sensitivity (SI) and positive changes associated with fibrinolytic     markers and lipid profile after a two month supervised aerobic training.   "
233725|NCT00906737|"     This study is being done to test the possible benefits of task-specific focused ankle     training using the Ankle-Bot on subjects with Multiple Sclerosis who have foot-drop. The     study also compares the effectiveness of task-specific focused ankle training using the     Ankle-Bot with conventional focused ankle therapy in improving the gait of subjects with MS.   "
233726|NCT00906750|"     Eligible research subjects will be randomized to receive either FluMist or inactivated     influenza vaccine then stratified by age and necessity to receive either one or two     immunizations. Subjects requiring one immunization will be immunized at Day 0. Subjects     requiring two immunizations will be immunized at Day 0 and Day 28. Subjects will be observed     for 30 minutes following vaccination and given a diary card to record symptoms after each     vaccination.   "
233727|NCT00906763|"     Chocolate consumption has long been associated with enjoyment and pleasure. Popular claims     confer on chocolate the properties of being a stimulant, relaxant, euphoriant and     antidepressant. These possible pharmacological actions might be related to various biogenic     amines, such as serotonin, dopamine, tyramine, histamine, phenylethylamine and     cannabinoid-like substances. Most amines are metabolized by monoamineoxidase-A (MAO-A) and     are therefore unable to pass the blood-brain-barrier. In contrast, phenylethylamine is a     direct dopamine releasing ingredient and as a substrate of MAO-B and due to its lipophilic     structure even capable to pass the blood-brain-barrier. Within this line, own clinical     observations suggested an increased chocolate consumption in patients with Parkinson's     disease (PD) compared to healthy subjects and to their pre-disease state.      In a previous study, we assessed the consumption of chocolate and non-chocolate sweets in PD     patients and their partners (as household controls) using a self-questionnaire. Consumption     of chocolate was significantly higher in PD patients compared to controls, while consumption     of non-chocolate sweets was similar in both groups. Our study suggests that chocolate     consumption is increased in PD independent of concomitant depressive symptoms measured by     BDI-1. Although reasons for increased chocolate consumption in PD remain elusive, it may     hypothetically be a consequence of the high content of various biogenic amines as a content     of cocoa influencing dopamine metabolism.      Therefore, in the present study we aim to study the effects of dark chocolate with high cocoa     content (85%) compared to chocolate without any cocoa (white chocolate) on motor symptoms in     PD patients as measured with UPDRS part III (motor score). The principle design of the     intervention is similar to the standard pharmacological challenge test for studying effects     on motor symptoms in PD (e.g. levodopa challenge test).   "
233728|NCT00906776|"     Randomised, controlled, clinical study to compare the effect of the combination of bone     ceramic and enamel matrix proteins (test) versus autogenous bone graft alone (control) in the     treatment of deep-wide intrabony defects   "
233729|NCT00906789|"     This is a clinical trial using retrospective data of two different software devices developed     by Riverain Medical Group: Softview and OnGuard 5.0. The two studies will be run     concurrently. Riverain Medical Group's computer systems are designed to assist radiologists     in their identification of lung cancer on chest radiographs. The current machine received FDA     Pre-Market Approval. This is to test two new software approaches.   "
233730|NCT00906802|"     One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric     emptying (DGE), otherwise known as gastroparesis, which is not fatal but results in     prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined as     nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a regular     diet after POD 14. The incidence of DGE has been reported to range from 5% to 72%.   "
233731|NCT00906828|"     The purpose of this study is to determine whether oral intake of COMT inhibitors affects the     smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced     Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma     concentrations of levodopa more fluctuating.   "
233732|NCT00906841|"     Phase II, multi-centric, open-label, study.      Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of     fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first     line of chemotherapy.   "
233733|NCT00906854|"     Introduction: Urinary incontinence is often seen as a problem that affects multipara and     old-aged women, however, there is evidence that during high impact physical activity, mainly,     or those ones which promote a sudden increase of intra-abdominal pressure, this symptom is     common, even among young women, physically active, and without known risk factors.      Objective: Evaluate the prevalence of urinary incontinence in nulliparous and nulligest women     who regularly practice physical activities.      Method: 108 women, nulliparous and nulligest, average age 23.9 years old (from 18 to 30 years     old) who exercise regularly. They were divided into 3 groups according to the regular     practice of exercise forms, they are (G1) weight training, (G2) aerobic exercises, included     jump, step and dancing classes, and (G3) swimming (crawl mode). All participants were     questioned about the perception of leakage of urine during the practice of exercises. The     established exclusion criterion included: surgeries of urinary tract, urinary infections,     gestations, child-birth, advanced aged, obesity, sedentariness and practice of only one form     of physical activity.   "
233900|NCT00919490|"     The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of     blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male     adult in Japan.   "
233734|NCT00906867|"     Vocal cord dysfunction is a rare clinical picture. It is labeled as a sudden and threatening     dyspnea. Patients with VCD may also present cough, hoarseness, wheezing, and chest tightness,     but an inspiratory stridor is the most common symptom. For this reason, such patients are     often misdiagnosed with refractory asthma, because of poor response to steroids and     bronchodilators. Diagnosis is suspected on clinical grounds and is confirmed with     laryngoscopy. The therapy consists of education, speech therapy and if necessary     psychotherapy. The purpose of the investigators' study is to characterize children,     adolescents, and young adults with VCD, and the evaluation of predictors as atopy, bronchial     hyperresponsiveness, and psychiatric features.   "
233759|NCT00907205|"     The purpose of this study is to evaluate the safety and tolerability of SF1126 in patients     with advanced or metastatic tumors by assessing the dose limiting toxicities (DLTs) and     defining the maximum tolerated dose given twice per week for 4 weeks and ultimately define a     recommended phase II dose.   "
233735|NCT00906880|"     Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination     of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human     African trypanosomiasis (HAT) in the meningo-encephalitic phase.      Overall objectives:      Assess the clinical tolerability, feasibility and effectiveness of NECT co-administration to     treat patients with T.b. gambiense human African trypanosomiasis (HAT) in the     meningo-encephalitic phase in actual real-life conditions (regular treatment centers of the     National HAT Control Programme, NGO treatment centers).      Primary objective:        -  Assess the clinical response of the NECT co-administration under field conditions.      Secondary objectives:        -  Assess the incidence and type of adverse events (AE), and the capacity of the treatment          centers to deal with these.        -  Assess the feasibility of the implementation of the NECT coadministration by the health          center.        -  Assess the effectiveness of the NECT co-administration at 24* months after treatment.   "
233736|NCT00906893|"     Hypoxia is recognized to be an independent predictor of clinical outcome in oncology. PET     using [18F]-FMISO has been described to be useful for the non invasive assessment of hypoxia     in cancer. The use of this radiotracer for brain tumours is very limited and there is no     standard to acquire and quantify [18F]-FMISO uptake. So there is a need for a methodological     evaluation of this PET tracer The purpose of this research is to define optimal parameters     for acquisition and data exploitation to quantify [18F]-FMISO uptake and so predict clinical     outcome in glioblastomas.      Low sensitivity to radiation of glioblastoma is partly caused by hypoxia. Hypoxia in tumours     is not predicted by tumour size. Detecting and monitoring tissue oxygenation are of great     interest to modify therapeutic strategies, including local dose escalation for radiotherapy     or select chemotherapeutic agents with better impact in glioblastomas.      PET with appropriate radiotracers, especially [18F]-FMISO, enables non-invasive assessment of     hypoxia. [18F]-FMISO only accumulates in viable hypoxic cells. So, it has been demonstrated     that PET using 18F-FMISO is suitable to localize and quantify hypoxia. But there isn't any     optimal acquisition protocol or standardized images quantification treatment. Thus, the     interpretation of [18F]-FMISO PET images and the predictive value of [18F]-FMISO SUV     (Standardized Uptake Value) remain unclear explaining the need of methodological approaches.   "
233737|NCT00906906|"     The purpose of this study is to characterize blood flow in the plastic tubing of a heart-lung     bypass machine during heart surgery. Technical specifications provided by the manufacturer do     not consider varying hemodynamic conditions such as temperature and hemoglobin levels which     affect blood viscosity and ultimately blood flow to and from the patient during heart-lung     bypass.      The investigator wishes to perform a prospective study of the heart-lung bypass tubing in     children that require heart-lung bypass during heart surgery.   "
233738|NCT00906919|"     The goal of this randomized controlled trial is to determine if greater effectiveness can be     achieved by the addition of lay-led self-management patient education to regular     professionally-led diabetes patient education in comparison to regular professionally-led     diabetes patient education only.   "
233739|NCT00906932|"     This is a two part study comparing the Trachview videoscope to standard laryngoscopy in their     ability to visualize the glottic opening. It is hypothesized that the glottic view is     improved with the Trachview videoscope. Not only can the Trachview provide an alternative and     often improved view of the airway, but can be used for teaching novice intubators.     Furthermore, the Trachview requires minimal deviation from standard intubating techniques and     thus, it is much easier to learn and use than many fiberoptic scopes currently available.   "
233740|NCT00906945|"     This study is designed to test the combination of Plerixafor with G-CSF for     chemosensitization in patients with relapsed or refractory AML.   "
233741|NCT00906971|"     The purpose of this study is to determine whether physiotherapy is effective in the treatment     of the chronic functional constipation in children.   "
233742|NCT00906984|"     The purpose of this protocol is to provide TheraSphere treatment for patients with liver     cancer who cannot be treated by surgery. The effect on the tumor and any side effects of     TheraSphere treatment will be examined. This study will provide supervised and limited access     to TheraSphere treatment at University California Irvine Medical Center.      TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has     been used previously in the treatment of liver tumors. When Y-90 is incorporated into very     tiny glass beads (TheraSphere), it can be injected to the liver through blood vessels     supplying the liver. This allows a large dose of radiation to be delivered to the tumor with     less risk of toxic effects from radiation to other parts of the body or to healthy liver     tissue. The radiation from TheraSphere is contained within the body and becomes minimally     active within 7 days after treatment due to physical decay. The glass beads remain in the     body, but do not cause any health problems. TheraSphere has been approved for use in the     treatment of liver cancer in the United States by the Food and Drug Administration on a     limited basis.   "
233772|NCT00907374|"     The objective of the study is to assess the effect of standard versus aggressive inhibition     of the renin-angiotensin system (RAS)in type 2 diabetic patients with microalbuminuria (MA)     on; a)progression of microalbuminuria, b)estimated glomerular filtration rate (eGFR),     c)endothelial dysfunction (measured by post-hyperemia arterial tonometry) and d)the slowing     of the progression of atherosclerotic disease (measured by carotid intima media thickness     [CIMT]).   "
233743|NCT00906997|"     Aims:        1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT)          versus colonoscopy every 10 years for the reduction of colorectal cancer-related          mortality at 10 years in average-risk population.        2. To determine the compliance and complications associated with both strategies.      Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias,     Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).      Study groups:        -  Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive          result.        -  Group II: colonoscopy.      Sample-size calculation: 27,749 subjects in each study group (total: 55,498).   "
233744|NCT00907010|"     Objective: Evaluate the muscular strength in the ageing process and identify the changes     between the abdominal muscles, upper and louver edges.      Method: 48 individuals participated in this study, being divided into four groups according     to the age: (G1) 11to 18 years old, (G2) 20 to 26 years old, (G3) 45 to 60 years old and (G4)     66 - 82 years old. The excluding criterion included people who work out more than three times     a week, severe arthrosin, stroke, significant cognitive deficit , obesity, use of ortheses     for louver members or any break, with or without metallic implant. The evaluation instruments     used were: (1) Esfigmomanômetro (EM), (2) Trunk flexor in the supine position,, (3) Jamar     Dinamômetro and (4) Preston Pinch Gauge Dinamômetro.   "
233746|NCT00907036|"     RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of     cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem     cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either     kill them or deliver cancer-killing substances to them without harming normal cells. When the     healthy stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving cyclosporine before and after the transplant may stop this from happening. Once the     donated stem cells begin working, the patient's immune system may see the remaining cancer     cells as not belonging in the patient's body and destroy them (called graft-versus-tumor     effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may     boost this effect.      PURPOSE: This phase II trial is studying the side effects of fludarabine phosphate,     melphalan, and alemtuzumab followed by donor stem cell transplant in treating patients with     relapsed Hodgkin lymphoma.   "
233747|NCT00907049|"     A prospective study to assess the association between the change in quality of sleep and the     change in intensity of pain in Spanish patients seen for subacute or chronic neck pain. The     objective is to determine the prevalence of sleep alterations, the association between     quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing     and depression.   "
233748|NCT00907062|"     Vitiligo is a common hypopigmentation disorder with significant psychological impact if     occurring before adulthood. One study investigating the use of Ginkgo biloba for the     treatment of vitiligo in adults reports effectiveness, but has significant flaws. We endeavor     to conduct an open label pilot clinical trial replicating the previous trial on 12     adolescents 12 to 18 years old. The purpose of the pilot is to test the feasibility of     recruitment and patient retention, variability of outcome measures, and identify major safety     concerns. The pilot will use 60 mg of standardized G. biloba two times per day (BID) for 12     weeks. The primary outcome will be the validated Vitiligo European Task Force (VETF)     evaluation form, secondary outcomes will include the Vitiligo Area Scoring Index (VASI),     assess repigmentation via photographs, and will monitor and report adverse reactions.   "
233749|NCT00907075|"     The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with     and without energy restriction.   "
233750|NCT00907088|"     Iron depletion in young children is common and may progress to iron deficiency anemia which     is associated with irreversible neurodevelopmental effects. Efforts to prevent iron depletion     are key to preventing these effects. In a recent study of 150 young children (12 to 38     months), we found that bottle fed children were almost three times as likely to be iron     depleted compared with cup fed children (37% vs 18%). Thus, we hypothesize that an     educational intervention designed to encourage timely bottle weaning will lead to a reduction     in iron depletion.   "
233751|NCT00907101|"     The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing     antibiotic sensitive and resistant strains of P acnes in vivo.   "
233752|NCT00907114|"     The purpose of this study is to determine the efficacy and safety of topic ketorolac in     treatment for center point thickness secondary to panphotocoagulation in proliferative     diabetic retinopathy.   "
233753|NCT00907127|"     The study will test whether damage of the heart nerves appears in patients before they     develop diabetes.   "
233754|NCT00907140|"     Rationale: Diagnostic procedures, such as positron emission tomography (PET) using     fluorodeoxyglucose (FDG), may help determine response to standard cancer therapy in patients     with cervical cancer      The purpose of this study is to evaluate the change in cervical tumor heterogenity as     measured by FDG-PET/CT imaging.   "
233755|NCT00907153|"     The purpose of this study is to determine if vitamin D will improve insulin resistance,     inflammation, and overall well-being in women with PCOS.   "
233756|NCT00907166|"     The objectives of this study are:        -  To determine the safety and MTD of CPI-613, when used in combination with Gemcitabine,          in cancer patients.        -  To compare the safety and efficacy of CPI-613/Gemcitabine combination vs. Gemcitabine          alone in patients with carcinoma of the pancreas.   "
233773|NCT00907387|"     The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate     to severe lateral canthal lines in adults and duration of effect.   "
233774|NCT00907400|"     The purpose of the study is to investigate the uptake in the body of naproxen; one of the two     active substances in PN400. We also want to show that the body's uptake of naproxen given as     PN400 is comparable to that of currently marketed naproxen tablets.   "
233834|NCT00918619|"     This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A     total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical     centres. The primary objective of this study is to show that the collagen based haemostatic     device Sangustop® is not inferior to a carrier-bound fibrin sealant (Tachosil®) in achieving     haemostasis after hepatic resection.   "
233757|NCT00907179|"     LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by     blocking certain enzymes. LBH589 has shown effects against cancer in laboratory studies and     in studies using animals; however, it is not known if this medicine will show the same     activity in humans. As of May 2006, approximately 100 patients have received treatment with     either an intravenous or capsule form of LBH589. Only the capsule form of LBH589 will be used     in this study. In addition, information from other research studies and laboratory studies     suggests that this study drug may help to treat lung cancer.      The main goal during the Phase I portion of this research study is to find out the highest     and safest dose of LBH589 that can be given in combination with pemetrexed in subjects with     lung cancer without causing severe side effects. The main goal of the Phase II portion of     this study is to find how the patient's lung cancer responds to the LBH589 in combination     with pemetrexed.      This study will also investigate how the patient's body processes the combination of LBH589     and pemetrexed. To determine this, the investigators will measure the amount of study drug in     the patient's blood. This will be done with a series of blood tests, called pharmacokinetic     (PK) tests. Other purposes of this study will be to determine the side effects of LBH589 in     combination with pemetrexed and whether or not this combination is effective in treating your     type of cancer.   "
233758|NCT00907192|"     Primary Objective:        1. To determine the frequency of self-reported over and under use of opioid analgesics in          patients with advanced cancer. Patients with advanced cancer are those patients who have          been described to have either one of the following: recurrent disease, those that have          failed multiple chemotherapies (more than second line therapy), locally advanced          disease, and metastatic disease.      Secondary Objectives:        1. To determine the association between patients' knowledge, attitudes and beliefs about          opioids, and frequency of deviation in opioid use with patients' demographic          information.        2. To determine association between alcohol abuse/chemical coping and self-reported          deviations in opioid use.        3. To determine the association between the use of opioids and patient-related barriers to          opioid use.   "
233760|NCT00907218|"     The purpose of this research study is to learn about the efficacy of a medication called     varenicline (Chantix) in treating ADHD in adults and in reducing cigarette smoking in adults     with ADHD. The investigators hypothesize that ADHD symptomatology in adults with ADHD will be     improved with varenicline treatment. The investigators also hypothesize that varenicline     treatment will result in significant reductions in cigarette smoking. Another objective of     this study is to more fully evaluate the response and tolerability to varenicline in this     group of cigarette smoking adults with ADHD.   "
233761|NCT00907231|"     This is a multi-center study to assess the diagnostic accuracy of the Troponin I assay in the     Biosite Triage Cardio3 Panel at the point-of-care (POC) in adults presenting to the emergency     department with possible acute myocardial infarction (AMI).   "
233762|NCT00907244|"     The purpose of this study is to get information regarding the usefulness and accuracy of this     new magnetic resonance imaging (MRI) technique - termed arterial spin labeling (ASL) - in the     diagnosis of pediatric brain tumors.   "
233763|NCT00907257|"     A study to determine if using 2 acne products in the morning is as safe and efficacious as     using one product in the morning and one product in the evening.   "
233764|NCT00907270|"     Participants will be randomly assigned in one of two groups. Group A: oral supplementation     with 4,000 IU of vitamin D (cholecalciferol). Group B: oral supplementation with 400 IU of     vitamin D (cholecalciferol). Both treatments will be consumed daily for 6 months.      Outcomes will be evaluated at baseline, three and six months. Variables related to leptin     resistance will be evaluated.      The main hypothesis is that vitamin D will diminish leptin resistance in overweight and obese     women. If the hypothesis is confirmed, women will show a reduction in the Resting energy     expenditure: serum Leptin ratio (REE: Leptin ratio), as well as a reduction of hunger, body     weight, body and abdominal fat and an increase in resting energy expenditure.   "
233765|NCT00907283|"     This trial is a multicenter, unblinded, single-arm pilot study, lasting one year (plus one     year extension Amendment n.3 25 August 2009, plus two years follow-up Amendment n.7) , to     evaluate the efficacy and safety of the chelator therapy with deferiprone on cerebral iron     accumulations. The drug will be administered in the dosage of 15 mg/kg twice daily. The     safety and tolerability of the drug will be evaluated by measuring hemochrome every seven     days with leukocyte formula count.      At 3, 6 and 12 months from the start of treatment, a neurological evaluation will be     performed using several specific evaluation scales (International Cooperative Ataxia Rating     Scale (ICARS); Unified Parkinson's Disease Rating Scale (UPDRS); Burke-Fahn-Marsden (BFM)).      Every 6 months of treatment, a brain magnetic resonance image (MRI) aimed at measuring iron     overload quantitatively, if possible.   "
233766|NCT00907296|"     This is an international, multi-center, randomized, double blind, placebo controlled study of     AMG 785 in skeletally mature adults with a fresh unilateral tibial diaphyseal fracture status     post a definitive fracture fixation with an intramedullary (IM) nail. The primary hypothesis     for this study is that AMG 785 compared with placebo is effective in reducing radiographic     healing time of fresh tibial diaphyseal fractures.   "
233767|NCT00907309|"     The purpose of the project is to improve adolescent behavioral counseling services in     healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy     (iMET) intervention that targets the use of tobacco, alcohol, and other drugs.   "
233768|NCT00907322|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     Dimebon following single ascending doses. A formal single ascending dose study of this nature     has not been performed to date in the Dimebon development program.   "
233769|NCT00907335|"     A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9     to 11 is safe and efficacious.   "
233770|NCT00907348|"     This is a prospective multicenter phase II pilot trial designed with the purpose of dose     finding to evaluate the efficacy and safety of treatment with Lenalidomide plus R-CHOP21     (LR-CHOP21) for elderly patients with untreated Diffuse Large B Cell Lymphoma (DLBCL).   "
233771|NCT00907361|"     This study will create a registry of patients with pacemakers and implantable ICDs who will     undergo clinically indicated MRI and will document the incidence of any adverse events or     changes in device parameters that might be associated with the procedure.   "
233775|NCT00907413|"     This research study is a phase III double arm, multicenter, randomized controlled clinical     trial comparing endoscopic retrograde cholangiopancreatography (ERCP) and stenting plus     photodynamic therapy (PDT) versus ERCP with stenting alone in adult patients with     unresectable cholangiocarcinoma.      The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in     increasing the survival time of patients with unresectable cholangiocarcinoma and to assess     the effect of PDT on both cholestasis and health-related quality of life (HRQoL).   "
233776|NCT00907426|"     This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution     application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis     of the eyelashes (inadequate or not enough eyelashes). There will be two different types of     subjects participating in the study 1)those with inadequate eyelashes due to natural causes     or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment.     There will be two treatment periods of six months each. Subjects will receive either the     study medication or vehicle in either of the two treatment periods.   "
233778|NCT00907452|"     This protocol (in patients aged 65 and over suffering from previously untreated multiple     myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the     number of patients analyzed and the implemented molecular diagnostics resources. The goal is     to be able to identify patients who will best respond to the study treatments or experience     the fewest associated side effects and improve prognosis, in order to optimize care     management in multiple myeloma.      To this end, the study seeks to predict the following parameters in these patients:        -  The treatment response and occurrence of adverse events linked to a          lenalidomide-dexamethasone combination or a melphalan-prednisone-thalidomide          combination.        -  Progression-free survival and overall survival.      Prediction of the treatment response and the occurrence of adverse effects will be based on:        -  An analysis of constitutive genetic traits linked to single nucleotide polymorphisms and          DNA copy number variations.        -  An analysis of changes in the tumor's genotype (change in the DNA copy number) and          phenotype (altered gene and micro-RNA expression).      Prediction of progression-free survival and overall survival will be based on an analysis of     changes in the tumor's genotype and phenotype.   "
233779|NCT00907465|"     The study is designed to develop methods for objectively measuring sedentary behavior, assess     the association between objectively measured sedentary behavior and cardiovascular disease     outcomes, and develop an intervention to reduce sedentary behavior, in African American     adults.   "
233780|NCT00907478|"     The purpose of this study is to evaluate changes in bone marrow morphology (structure) after     long-term exposure to romiplostim.   "
233781|NCT00907491|"     Cough is part of the defense mechanism to protect the lung from foreign particles and remove     secretions from the airways. However, at times it becomes a bothersome, annoying symptom that     interferes with the quality of life, sleep pattern and exercise tolerance of the patient.      People with respiratory infection, asthmatic patients and CF patients suffer from a multitude     of pathologies of airways and are often inflicted with chronic cough.      Treatment of cough in these patients consists of many types of expectorants, cough     suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical     therapy (PT) is often prescribed as part of the treatment regime.      The primary objective of the study is to evaluate the efficacy and validity of novel cough     counting device based on the WIM Technology.   "
233782|NCT00907504|"     Gemcitabine and cisplatin given together is a standard treatment option for advanced lung     cancer patients. The purpose of this study is to assess if the life span is longer in     patients taking the investigational drug CP-751,871 in combination with gemcitabine and     cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs,     1,210 participants will be required in order to have an adequate sample size (1,100 evaluable     patients) and power to detect a 30% prolongation of survival on the experimental arm.   "
233783|NCT00915473|"     Migraine is a common neurological condition that can be disabling, particularly if chronic.     Greater occipital nerve (GON) block has been utilized for decades for the treatment of     migraine in the absence of a single randomized, placebo-controlled trial documenting its     effectiveness.      Hypothesis: Greater occipital nerve block reduces the frequency of days with moderate or     severe headache in patients with episodic or chronic migraine.   "
233784|NCT00915486|"     Although major improvements in the management and treatment of diabetic foot ulcers have been     made, the clinical and financial burden of such long-term wounds is still high and is likely     to increase as the general population ages. The large population affected by diabetic foot     ulcers and the high rates of failure ending with amputation even with the best therapeutic     regimens have resulted in the development of new therapies. I-020201 is a bioactive therapy     intended for topical treatment of hard-to-heal diabetic foot ulcers, stimulating the     granulation tissue formation. This study aims to evaluate the safety and efficacy of I-020201     in adjunct to good standard of care in patients with chronic diabetic foot ulcer.   "
233785|NCT00915499|"     The purpose of this study is to determine whether adaptive servo-ventilation (ASV) or     continuous positive airway pressure (CPAP) is better at treating complex sleep apnea over     time.   "
233786|NCT00915512|"     The purpose of this study is to evaluate the response to treatment and safety of paliperidone     extended-release (mechanism to dissolve a drug over time in order to be released slower and     steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with     symptoms of emotional instability, detachment from reality, often with delusions and     hallucinations, and withdrawal into the self).   "
233787|NCT00915525|"     The purpose of this study is to assess the long term safety and effectiveness of botulinum     toxin type A in treating patients with idiopathic overactive bladder with urinary     incontinence.   "
233788|NCT00915538|"     This study will compare the amount of bronchial tube relaxation from the formoterol medicine     contained in the symbicort pMeterd Dose Inhaler( a combination of budesonide ,a steroid, and     formoterol, a drug which relaxes the bronchial smooth muscle. The comparison will be using     the pMDI in the usual fashion to the pMDIs and a spacer which allows more time for breathing     in the medication. Breathing tests will be measured over a 12 hour period for the comparison.   "
233789|NCT00915551|"     This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when     applied to an area of skin containing 4-8 AK lesions on the face or scalp.   "
233804|NCT00915746|"     This is an open-label (both the physician and healthy volunteer know which treatment will be     administered) study to assess the pharmacokinetics (process by which JNJ-31001074 is     absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken     alone and in combination with ketoconazole. The study consists of three phases: a screening     phase to determine eligibility, an open-label treatment phase consisting of three periods and     an end-of study/early withdrawal assessment phase.   "
233793|NCT00915603|"     This randomized, double blind, placebo controlled trial will evaluate the impact of adding     everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line     treatment of women with HER2-negative metastatic breast cancer. Patients will be randomized     (1:1) to receive either paclitaxel/bevacizumab/everolimus (Treatment Arm 1) or paclitaxel/     bevacizumab/placebo (Treatment Arm 2). Patients will be evaluated for response to treatment     every 8 weeks; responding and/or stable patients will continue treatment, with re-evaluations     every 8 weeks, until tumor progression or      intolerable toxicity occurs. Outcomes will be assessed for each treatment arm      separately. This trial is not intended to compare treatment arms primarily. Any such analyses     are exploratory and will be conducted without adjustment for multiple hypothesis testing.   "
233794|NCT00915616|"     Gastro-Esophageal Reflux Disease was defined as a condition that develops when the reflux of     stomach contents causes troublesome symptoms and/or complications. Many drugs used for the     treatment of GERD such as omeprazole (a proton pump inhibitor) which is widely used     anti-ulcer drug and has been demonstrated to protect against esophageal mucosal injury.     Melatonin has been found to protect the gastrointestinal mucosa from oxidative damage caused     by reactive oxygen species in different experimental ulcer models. The aim of this study is     to evaluate the role of exogenous melatonin in the treatment of reflux disease in human     either alone and in combination with omeprazole therapy.   "
233795|NCT00915629|"     Vulvovaginal candidiasis (VVC) is a common infection among women that is associated with     considerable morbidity and health-care cost. 75% of women will suffer of Candida infection     for at least one time in their life. 20% of women who suffer from VVC will have ≥ 4 episodes     of VVC during the one year prior to the survey. 80% of these VVC are caused by Candida     albicans. Current treatments, based on imidazoles, face many failures or recurrences. The     type of probiotic Lactobacillus may participate in the prevention of recurrent     vulvo-vaginitis in reducing the proliferation of intestinal Candida albicans, its adherence     to the vaginal walls, the potentiation of its propagation. The primary objective of this     study was to investigate if our supplementary treatment could improve the initial cure rate     after vaginal econazole therapy.   "
233796|NCT00915642|"     The objectives of the present study are:        1. to evaluate if overnight weight loss is dependent on sleep structure assessed by          polysomnography;        2. to compare weight loss rate during sleep and awake rest;        3. to compare night weight loss profile of normal and obese volunteers.   "
233797|NCT00915655|"     The purpose of this study is to evaluate pharmacokinetics (what body does to medication),     safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir     (DRV/rtv) administered once daily, in combination with an investigator-selected background     regimen consisting of other antiretrovirals (ARVs) ie, 2 nucleoside/nucleotide reverse     transcriptase inhibitors (NRTIs), in treatment-naive (never treated before) HIV-1 infected     adolescents aged from 12 to <18 years and weighing at least 40 kg.   "
233798|NCT00915668|"     The main purpose of this research study is to evaluate the effect of multiple doses of an     investigational drug known as JNJ-31001074 on the single dose of combination oral     contraceptive Ovral-L containing ethinyl estradiol and levonorgestrel in healthy women who     cannot bear children. This study will look at the safety, tolerability (how the drug makes     you feel) and pharmacokinetics (what your body does to the drug) of either drug alone and in     combination in healthy women.   "
233799|NCT00915681|"     Legalon® SIL will be administered to patients with amatoxin poisoning diagnosed by history,     gastrointestinal symptoms, elevated liver enzymes, and/or diagnostic assay (should one become     available). Patients may or may not also demonstrate abnormalities in bilirubin and/or     creatinine. Treatment consists of a 5 mg/kg loading dose followed by 20 mg/kg/day via     continuous infusion. The treating physician is expected to administer supportive therapy of     his/her choosing but consistent with best practices. Legalon® SIL will be stopped when     coagulopathy is no longer present, and when liver function tests have returned significantly     towards the normal range. Patients will be followed 7-14 days after the end of Legalon® SIL     therapy with follow up lab studies.   "
233800|NCT00915694|"     RATIONALE: Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor     cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     nelfinavir mesylate together with radiation therapy and temozolomide may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate     when given together with radiation therapy and temozolomide in treating patients with     glioblastoma multiforme.   "
233801|NCT00915707|"     This study is designed to study the pathways through which short sleep duration or poor sleep     quality can lead to an increased risk of developing diabetes and obesity.   "
233802|NCT00915720|"     This is a pilot study to determine if implanted loop recorders can more effectively monitor     atrial fibrillation recurrence after atrial fibrillation ablation.   "
233835|NCT00918632|"     The study is designed to evaluate the effect of food on typical blood levels obtained after     oral dosing of AG-013736. Drug levels in blood will be compared after an overnight fast and a     high-fat, high-calorie meal.   "
233836|NCT00918645|"     RATIONALE: Diagnostic procedures, such as radionuclide imaging using calcium-41 (41Ca)     chloride aqueous solution, may help predict progressive disease in patients with prostate     cancer and bone metastasis.      PURPOSE: This clinical trial is studying how well calcium-41 (41Ca) chloride aqueous solution     works in diagnosing patients with prostate cancer and bone metastasis.   "
233837|NCT00918658|"     RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer     to study in the laboratory may help doctors find better ways to treat the cancer.      PURPOSE: This research study is looking at natural killer cells in bone marrow and blood     samples from patients with hematologic cancer and from patients who do not have cancer.   "
233803|NCT00915733|"     Percutaneous coronary intervention (PCI) with stent implantation is the preferred reperfusion     strategy for treatment of acute myocardial infarction (AMI). Despite advances in both devices     and pharmacological support for AMI patients undergoing PCI, the risk of recurrent ischemic     events has been higher than that of elective PCI. Among therapeutic options for surmounting     clopidogrel hyporesponsiveness, higher loading doses and maintenance doses of clopidogrel     achieved significant enhancements in the speed of onset and intensity of inhibition and these     approaches have been widely adapted in clinical practice. Interestingly, recent studies found     that carriers of the loss-of-function hepatic cytochrome (CYP) 2C19 allele had significantly     lower levels of the active metabolite of clopidogrel, diminished platelet inhibition, and a     higher rate of major adverse cardiovascular events than did non-carriers, in the setting of     PCI and acute coronary syndrome (ACS). These findings raise the need of solutions to overcome     enhanced post-clopidogrel platelet reactivity by the influence of the loss-of-function     CYP2C19 allele. Increasing the dose of clopidogrel, new potent P2Y12 antagonists (such as     prasugrel), or other antiplatelet drugs such as cilostazol may be alternative antiplatelet     regimens in patients with the loss-of-function CYP variant. A recent study demonstrated that     adjunctive cilostazol to dual antiplatelet therapy (triple antiplatelet therapy) intensified     platelet inhibition as compared with a high maintenance-dose (MD) of 150 mg/day. Therefore,     triple antiplatelet therapy could also be an alternative antiplatelet therapy to improve     platelet inhibition and clinical outcomes in carriers of CYP2C19 mutant allele.      The purpose of this study was to determine the impact of adjunctive cilostazol on platelet     inhibition in carriers and non-carriers of the loss-of-function CYP2C19 allele. The     investigators compared the enhanced inhibition of platelet aggregation by adjunctive     cilostazol 100 mg twice daily versus high-MD clopidogrel 150 mg/day in AMI patients treated     with emergent coronary stenting, according to the CYP2C19 polymorphism.   "
233806|NCT00915772|"     A phase III randomised, double-blind parallel group extension study to investigate the     efficacy and safety of twice daily administration of the free combination of linagliptin 2.5     mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with     metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing     the double-blind part of study 1218.46   "
233807|NCT00915785|"     The purpose of this study is to assess the hematological and cytogenetic responses with 5     azacytidine in patients over 55 years of age with MDS/AML due to chromosome 7 abnormalities     and to assess the hematological and cytogenetic response rates in patients with relapsed AML     and chromosome 7 abnormality.   "
233808|NCT00915798|"     The study investigated the underlying mechanisms of smoking in young adults by examining the     associations between smoking, brain activity, dopamine genes, and attention deficit     hyperactivity disorder (ADHD).   "
233809|NCT00918294|"     QuickOptTM optimization method provides a quicker, simpler and reliable alternative to     standard echocardiography methods for optimization of sensed AV, paced AV and V-V delays in     patients with CRT-P devices   "
233810|NCT00918307|"     Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining     malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular     diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco     smoking cessation has well known benefits on mortality and morbidity in the general     population where tobacco cessation assistance programs are increasingly implemented. However,     smoking cessation interventions have never been evaluated among HIV-infected patients. This     trial aims at evaluating the efficacy and safety of varenicline for smoking cessation     compared with placebo.   "
233811|NCT00918320|"     The purpose of the study is to determine whether the combination of Hycamtin (Topotecan) and     Temozolomide is effective in the treatment of relapsed and refractory neuroblastoma and other     paediatric solid tumors.   "
233812|NCT00918333|"     This phase I/II trial studies the side effects and best dose of panobinostat and everolimus     when given together and to see how well they work in treating patients with multiple myeloma,     non-Hodgkin lymphoma, or Hodgkin lymphoma that has come back. Panobinostat and everolimus may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
233813|NCT00918346|"     The objective of this study is to investigate the pharmacodynamics (as expressed in     intraocular pressure [IOP]) of two formulations of tafluprost 0.0015% eyedrops (preserved and     unpreserved) in patients with open-angle glaucoma or ocular hypertension.      The primary aim of this study is to show that IOP reduction between the two formulations is     equivalent at the end of the 4 week treatment period.   "
233814|NCT00918359|"     Heat Intolerance (HI) is a life threatening deficiency that can lead to heat exhaustion, heat     stroke (and possibly death) in a large number of military and civilian occupational groups.     We have demonstrated malfunction of transcriptional pathways in the heat stressed HI     phenotype and an altered gene expression profile compared to Heat Tolerant (HT) individuals.     Such differences are evident even under normothermic basal/comfort conditions. Heat and     exercise challenges during the heat tolerance test (HTT) further emphasize the differences     between the groups, particularly during recovery at comfort temperatures. Our results     indicate that it may be possible to identify markers of heat intolerance. To achieve this     goal, we plan to design a cellular (lymphocyte) HTT experimental model and detect gene     expression profiles using customized DNA microarrays and bioinformatic tools (the genes     selected will be based on our previous DNA microarray studies). Lymphocyte samples collected     from HT and HI individuals under resting/comfort conditions will be examined. Treatments and     analyses are designed to reveal HI-associated gene-expression profiles (constitutive or     inducible), and thereby find lymphocyte markers to identify individuals predisposed to heat     injury. The identification of such subjects could prevent unnecessary loss of life. Notably,     the rapidly changing climate in our era increases the number of occupation/age groups in     which manifestations of HI will appear.   "
233815|NCT00918372|"     The aim of this study is to determine the effects of extreme fitness in women. The incidence     of coronary artery disease observed via multislice computed tomography (MSCT) angiogram will     be compared with age and risk-matched controls from both sedentary and fitness activity     groups who have never been significant runners. Life style, training volume and risk factors     will be assessed.   "
233838|NCT00918671|"     From 1 January 2004 to 31 December 2006 64 individuals with probable medication overuse     headache were included in a randomized, 1-year open-labeled, multicentre study to evaluate     the effect of early introduction of prophylactic treatment compared to abrupt withdrawal and     with a control group (ClinicalTrials.gov number NCT00159588). In this follow-up, randomized     patients still alive 4 years after primary inclusion time will be invited to a follow up     interview, evaluating the headache complaints and the proportion of recurrent medication     overuse.   "
233839|NCT00918684|"     The purpose of this study is to look at the relationship between age related structural brain     changes and changes in depressive symptoms,disability and several aspects of cognitive     functioning following treatment with escitalopram.   "
233816|NCT00918385|"     This is a phase II multi-center study to determine the clinical impact of using a     patient-specific genomic expression signature of androgen receptor (AR) activity to determine     therapy for patients with castration-resistant metastatic prostate cancer (CRPC). After     patient eligibility is determined, the genomic signature will be applied to fresh frozen     tissue harvested from a metastatic lesion during image-guided biopsy. After assessing for     androgen receptor activity, the investigators will select patients for either continued     androgen manipulation with nilutamide (high AR activity) or targeted therapy with dasatinib     (low AR activity). Once patients develop a first progression on either arm, patients will     receive combination therapy with dasatinib and nilutamide. The primary aim is to estimate the     median progression free survival in men with CRPC treated according to tumor AR activity. The     investigators hypothesize that by treating men based upon AR activity, median progression     free survival (PFS) will improve from a historical median of 3.0 months to 6.0 months.   "
233817|NCT00918398|"     The primary objective is to investigate the pharmacokinetics of AZD1981 given in different     formulations and to measure renal clearance   "
233818|NCT00918411|"     The purpose of this study is to explore and examine endpoints that allow evaluation of the     clinically significant improvements, focusing on the patient's chief complaint and the     severity of major IBS symptoms by this drug in patients with diarrhea-predominant irritable     bowel syndrome (IBS).   "
233819|NCT00918424|"     Follow-on study to continue evaluation of the safety of OXC XR as adjunctive therapy in     pediatric epilepsy   "
233820|NCT00918437|"     The aim of this study is to determine the postoperative course including effects on the     quality of life following soft palate surgery with radiofrequency knife (RAUP).   "
233821|NCT00918450|"     This is a Phase 2b, open-label, multicenter, global study assessing the safety and efficacy     of ABT-263 in subjects with B-cell CLL who have failed at least one prior     fludarabine-containing regimen.   "
233822|NCT00918463|"     This is a Phase II, single institution, single-arm, open-label study of oral dasatinib     monotherapy administered to subjects with relapsed or refractory aggressive DLBCL.      This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.      Research Hypothesis: Dasatinib, when administered orally at a continuous dose of 100 mg once     daily, will be safe and effective in treating subjects that have failed prior therapies to     diffuse large B cell lymphoma (DLBCL) or have relapsed disease.   "
233823|NCT00918476|"     The purpose of this study is to estimate the effect of filibuvir on the pharmacokinetics of     ethinyloestradiol [EE] and levonorgestrel [LN], to assess the safety and tolerability of 600     mg BID of filibuvir in healthy women and to investigate the pharmacokinetics of 600 mg BID of     filibuvir in healthy women.   "
233824|NCT00918489|"     Primary objective of the study is to investigate the efficacy of vorinostat in patients     suffering from selected histological types of soft tissue sarcoma. Further evaluations relate     to the safety and tolerability of vorinostat, its pharmacokinetics (course of plasma     concentration over time) and pharmacodynamics (mode of action). Only subjects with advanced,     metastatic disease will be included in this trail.   "
233825|NCT00918502|"     The primary objective of the study is to gather data to correlate physiological signals     measured by the AVIVO™ Mobile Patient Management System with the patient's respiratory     status, including apnea and hypopnea events, during polysomnography   "
233826|NCT00918515|"     This is a Phase I, single centre, open label study to assess the safety, tolerability,     pharmacokinetics (PK) and pharmacodynamics of intravenous AZD3043 after single ascending     doses in healthy male volunteers.   "
233827|NCT00918528|"     The aim of this study is to evaluate the efficacy of local injected mitomycin C at the time     of internal urethrotomy in order to prevent the recurrence of urethral strictures.   "
233828|NCT00918541|"     20 patients will be recruited. The aim of the study is to determine the natural progression     of atherosclerotic disease.   "
233829|NCT00918554|"     The purpose of this study is to determine whether methotrexate is a effective corticosteroid     sparing agent in the treatment of sarcoid-associated uveitis.   "
233830|NCT00918567|"     Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there     is only one published study specifically designed to evaluate its efficacy in school     settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3     mg/kg, significantly reduced teacher rated ADHD symptoms (Weiss et al., 2005). However,     children are typically referred for treatment because of real life problems in functioning,     not symptoms (Pelham, Fabiano, & Massetti, 2005). While ATX has been found to produce     functional improvements at home, the Weiss study found limited results in this area at     school.      Furthermore, almost no research has examined the effects of combining ATX and behavior     therapy (BT). In the MTA, adding BT to stimulants improved teacher ratings of     hyperactivity/impulsivity and increased the number of subjects reaching optimal response     (Swanson et al., 2001). Therefore, it is possible that the addition of BT to ATX may improve     functional performance in the classroom. The effects of combined therapy may be even larger     for ATX as monotherapy with nonstimulants produces smaller effect sizes than with stimulants.      Objective: The primary objective was to evaluate the effects of ATX alone and in combination     with BT on the school functioning of 56 children ages 6-12 with ADHD. Outcomes were assessed     using traditional symptoms measures as well as functional measures of academic and behavioral     improvements in the classroom.   "
233831|NCT00918580|"     This study is to evaluate the safety, tolerability and immunogenicity of 13-valent     pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been     vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of     antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease     after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18     years of age. They will be given the vaccination twice, each vaccination separated by     approximately 6 months.   "
233832|NCT00918593|"     By applying short electric pulses to cells, the cell membranes can become permeabilised     (electroporation). This can be used augment the effect of chemotherapy, by providing direct     access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several     hundred fold, enabling once-only treatment. The investigators wish compare     electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm     in diameter from any kind of histology.   "
233840|NCT00918697|"     In this prospective randomized clinical trial, confocal microscopy was used to evaluate the     effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive     keratectomy (PRK)on corneal cellular elements. Sixty-six eyes of 33 subjects with a spherical     equivalent less than -4.00 D who completed all follow-up visits were evaluated.   "
233841|NCT00918710|"     High risk papillomavirus (HR-HPV) have an oncogenic role in Oropharyngeal squamous cell     carcinomas (OP-SCC) in at least 25% of the cases and the prevalence is increasing. HPV+ might     be more chemo and radio sensible with a better prognosis (disease-free survival (DFS) and     overall survival (OS) as compared to HPV negative OP-SCC ; hypothesis : 2y DFS > 20%     improvement). The principal objective is to determine the impact of the status of HR-HPV in     the prognosis of the OP-SCC. The principal criteria is the 2-years DFS.      Secondary objective : virologic characteristics of HPV+ tumors.   "
233842|NCT00918723|"     This phase I/II trial studies the side effects and best dose of vorinostat when given     together with fludarabine phosphate, cyclophosphamide, and rituximab and to see how well they     work in treating patients with previously untreated B-cell chronic lymphocytic leukemia (CLL)     or small lymphocytic lymphoma (SLL). Vorinostat may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as rituximab, may block cancer growth in different ways by targeting certain     cells. Giving vorinostat together with fludarabine phosphate, cyclophosphamide, and rituximab     may be a better treatment for CLL or SLL.   "
233843|NCT00918736|"     The aim of this study was to investigate the efficacy and safety of three weekly     intraarticular injections of Hyaluronate (HA) in patients with unilateral ankle     Osteoarthritis (OA).   "
233844|NCT00918749|"     Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study     in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also     participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized     to 1 of 3 treatment regimens for 3 months.   "
233845|NCT00918762|"     RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or     malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not     yet known whether transoral robotic surgery is more effective than standard surgery in     diagnosing and treating larynx and pharynx tumors.      PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared     with standard surgery in treating patients with benign or malignant tumors of the larynx or     pharynx.   "
233846|NCT00918775|"     The goal of this clinical research study is to learn if the surgical removal of your primary     tumor or the parts of the cancer that has spread to other parts of the body is a good method     for treating patients who have kidney cancer. Only the parts of the cancer that has spread     will be removed during the surgery.   "
233847|NCT00918788|"     RATIONALE: Collecting and storing samples of breast tissue from patients who have undergone     biopsy or surgery to test in the laboratory may help the study of cancer in the future.      PURPOSE: This laboratory study is looking at samples of breast tissue from women who have     undergone breast biopsy or surgery.   "
233848|NCT00918801|"     This study is an expansion of a previous study done to determine how thinking skills relate     to hypoglycemia (low blood sugar) and certain regions of the brain in children and     adolescents. In this study, the investigators are testing thinking skills and measuring brain     activity in adolescents with and without type 1 diabetes mellitus.   "
233849|NCT00918814|"     Dose Ranging and Dose Frequency of LIPO-102   "
233850|NCT00918827|"     RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who     have undergone surgery and chemotherapy may help doctors predict how well patients will     respond to treatment.      PURPOSE: This research study is looking at tumor samples from patients with stage III colon     cancer who have undergone surgery and chemotherapy.   "
233851|NCT00918840|"     PHPC-02 is a phase II, randomized, placebo-controlled trial designed to investigate whether     therapeutic immunization during highly active antiretroviral therapy (HAART) induces     elevations of HIV-specific T cell precursors with high proliferative capacity (PHPC) in     HIV-1-infected individuals, and whether the quantity of PHPC correlates with the viral load     set point following analytical treatment interruption (ATI). Subjects will be randomized to     receive either DermaVir Patch (8 subjects per cohort) or DermaVir Patch Placebo (8 subjects     per cohort) every four weeks for three applications while receiving maximally suppressive     HAART. HAART will be discontinued at Week 9 for an ATI period of 20 weeks.   "
233852|NCT00918853|"     This multicentric prospective study evaluates the role of the margins resection and the     ganglionic status when using a quality standard for the resection of adenocarcinoma of the     head of the pancreas.   "
233853|NCT00918866|"     The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse     effects during Right Heart Catheterization. This research was requested by the FDA.   "
233854|NCT00918879|"     Saxagliptin is a new investigational medication being developed for treatment of type 2     diabetes. This study is designed to evaluate the efficacy and safety in adult Indian patients     with inadequate glycaemic control with diet and exercise.   "
233855|NCT00918892|"     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer     may help doctors identify biomarkers related to cancer.      PURPOSE: This research study is looking at tumor tissue samples from patients who have     undergone surgery for breast cancer.   "
233856|NCT00918905|"     Patients with COPD are often admitted to the hospital with an exacerbation. It is the most     common cause for admissions to medical wards. The patients are often readmitted. This is har     great impact on health economy and is a significant factor to medical beds.      The aim of this study was to investigate the effect of telemedicine consultations between     respiratory nurses at the hospital and COPD patients in their homes after a discharge from     the hospital, which was caused by an exacerbation.   "
233883|NCT00919269|"     The purpose of this study is to collect and store tumor tissue, blood, and bone marrow     samples from patients with soft tissue sarcoma that will be tested in the laboratory.     Collecting and storing samples of tumor tissue, blood, and bone marrow from patients to test     in the laboratory may help the study of cancer.   "
233857|NCT00918918|"     Rationale: High-density lipoprotein (HDL), which is consistently increased after moderate     alcohol consumption, is an abundant plasma lipoprotein that is generally thought to be     anti-inflammatory in both health and infectious disease. HDL binds and neutralizes the     bioactivity of potent bacterial remnants such as lipopolysaccharides (LPS) which stimulate     the host innate immune responses.      Primary objective: To explore whether prolonged moderate alcohol consumption affects in vivo     cytokine response after a low dose of LPS in young, normal-weight men.   "
233858|NCT00918931|"     The goal of this clinical research study is to learn if obatoclax mesylate can help to     control systemic mastocytosis. The safety of this drug will also be tested.   "
233859|NCT00918944|"     To determine whether an innovative clinical decision support system embedded in an existing     electronic health record (EHR) will improve provider adherence to the existing National     Asthma Education and Prevention Program (NAEPP) guidelines.      12 primary care pediatric practices at The Children's Hospital of Philadelphia(both urban and     suburban sites) will be randomized to receive either a passive EHR (control sites) or an     interactive decision support system (intervention sites).   "
233860|NCT00918957|"     This study is designed to show how well tobramycin inhalation powder works and how safe it is     when produced by a modified manufacturing process   "
233861|NCT00918970|"     Context: A major lack of organ donors is a serious public health problem. It determines a     prolonged delay before a transplant can be performed and thus a significant number of deaths     of patients waiting for transplantation. The aim of this project is to reduce the delay of     the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit.      The diagnosis of brain death is strictly defined by the law and relies either on two     consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack     of cerebral circulation during a brain angiography performed after suspecting brain death on     the clinical exam. However, in usual practice, it is difficult to have all the needed     clinical arguments, and their interpretation can be difficult in the pathological context.     This may participate in the delay and the lack of patients potentially donors.      Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous     ECG recording. The investigators could find that a decrease in autonomic nervous system     activity, as measured through the ECG, was correlated to the transition to brain death     assessed by cerebral angiography. The loss of cardiac variability was always observed between     two cerebral angiographies, one before and the second after brain death. This study allowed     the investigators to calculate the threshold values of sympathetic and parasympathetic     activities to confirm brain death.   "
233862|NCT00918983|"     This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the     treatment of BPH (benign prostatic hyperplasia) as compared to placebo.   "
233863|NCT00918996|"     Cesarean section is now the most common major surgical procedure performed on women world     wide. In the United States, approximately 1 in 4 deliveries is by this method. With the     increasing numbers of cesarean sections, there is the need to utilized evidence based     techniques to optimize outcomes and minimize complications.Creation of the bladder flap is an     integral step of the standard cesarean section. The bladder flap is made by superficially     incising and dissecting the peritoneal lining to separate the urinary bladder from the lower     uterine segment. Started in the pre-antibiotic era, the rationale for the bladder flap was to     enable the surgeon gain access to the lower uterine segment while minimizing injury to the     bladder. Its subsequent closure was supposed to protect the peritoneal cavity from     intrauterine infection. Since then, closure of the bladder flap has been demonstrated to be     unnecessary and has been abandoned. The bladder flap however, continues to be performed     without evidence of benefit.      Evidence on the role of the bladder flap in cesarean section is very limited. In emergent     cesarean sections where rapid delivery is the goal, the bladder flap is commonly omitted. A     simplified method of cesarean section (Pelosi-type) including omission of the bladder among     other modifications has been shown to be safe and cost saving. The single randomized trial on     omission of the bladder flap as the only modification suggests short term benefits including     shorter operating times, reduced blood loss and decreased postoperative analgesic     requirements. This study has been criticized for evaluating only short term outcomes and     including only primary cesarean sections. The paucity of evidence for or against this     commonly utilized technique in cesarean section is the rationale for this study.      The goal of this study is to employ a well designed randomized controlled clinical trial to     evaluate the effects of omitting the bladder flap creation at cesarean section. We     hypothesize that omission of the bladder flap in both primary and repeat cesarean sections     will be associated with shorter operating time without a significant increase in     intraoperative and postoperative complications.   "
233864|NCT00919009|"     Most HCC patients are diagnosed at advanced stages in Korea, transcatheter arterial     chemoembolization is considered a key modality for palliative treatment in these HCC     patients. TACE is currently one of the mainstays of palliative treatments worldwide for     patients with inoperable HCC and it has shown survival benefits in patients with unresectable     HCC. TACE consists primarily of directly targeted chemotherapy and embolization of arteries     feeding the tumors, inevitably resulting in a hypoxic insult to HCC and surrounding liver     tissues. Ischemic injury after TACE has been found to induce the upregulation of circulating     vascular endothelial growth factor (VEGF), which is essential for tumor growth, invasion and     metastasis in patients with HCC. Recent studies have shown a significant correlation between     pre-TACE level of circulating VEGF or VEGF upregulation after TACE and HCC characteristics,     including tumor size, vascular invasion, and metastasis. TACE consists primarily of directly     targeted chemotherapy and embolization of arteries feeding the tumors, inevitably resulting     in a hypoxic insult to HCC and surrounding liver tissues. Central tumor hypoxia was found to     upregulate proangiogenic growth factors, which are potent mediators of tumor angiogenesis.     Therefore, expression of circulating or tissue VEGF was enhanced after TACE in patients or     animals with HCC, and there could be some probability of adverse effects of TACE in HCC     patients.      In addition, the investigators demonstrated that a transient increment of serum VEGF level     after TACE was significantly correlated with poor outcomes of tumor progression, especially     outcomes relevant to distant metastasis.      Therefore, these findings suggest a rationale for applying adjuvant therapy with     anti-angiogenesis agent additional treatment of anti-angiogenesis after TACE or during TACE     in a selected group of patients HCC.      The aim of this study is to evaluate efficacy and safety of sorafenib 400 mg bid with TACE in     patients with unresectable and/or inoperable HCC.   "
233865|NCT00919022|"     Cyproterone acetate (CPA) is a steroidal antiandrogen which has affinity with progesterone     and with glucocorticoid receptors. Cyproterone acetate is long-term proven effective     treatment of inoperable carcinoma of the prostate.      Sexual functions remain very important in men with prostate cancer. However sexual functions     are deteriorating fast with course of the disease. The influence of CPA on sexual functions     remains controversial. IIEF-5 erectile dysfunction questionnaire is currently widely used     validated simple scoring system for diagnosing of erectile dysfunction and belongs to most     used systems in Czech Republic. At present there are no data on CPA influence on IIEF-5     scored erectile dysfunction within the use of its indication in prostate cancer.   "
233866|NCT00919035|"     This is a single institution, open label, phase II study in androgen-independent prostate     cancer patients who are chemotherapy-naïve. Patients will receive Torisel® 25 mg weekly.     Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or     the investigator's discretion.   "
233867|NCT00919048|"     To compare uroflowmetry measurements of patients undergoing urodynamic testing as part of an     incontinence work-up in an urogynecology practice to healthy female volunteers.   "
234131|NCT00912236|"     Obesity is associated with an impaired functioning HDL (good cholesterol) resulting in an     acceleration in the development of atherosclerosis. This study will evaluate HDL     functionality in patients with BMI (Body Mass Index) 20 - 25 and BMI >30   "
233868|NCT00919061|"     The purpose of this study is to test an investigational combination of drugs for bile duct or     gallbladder cancers.      Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat     bile duct and gallbladder cancers. We are looking to improve treatment results. We will     attempt to do so by adding sorafenib (a type of monoclonal antibody) to your treatment plan.     Sorafenib acts by attaching to blocking specific targets on cells. These targets may help the     cancer cells grow and divide. This study will help answer the question of whether sorafenib     is a helpful drug in patients with bile duct or gallbladder cancers when given with     gemcitabine and cisplatin.      This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects,     good and/or bad, sorafenib in combination with gemcitabine and cisplatin has on advanced bile     duct and gallbladder cancers.   "
233869|NCT00919074|"     This research project will compare the use of the double wire technique with the placement of     a pancreatic duct (PD) stent to achieve deep biliary cannulation without the use of a precut     papillotomy. Currently, the data supporting either of these approaches is limited to the     referenced case series. More data on the success and complication rates of these techniques     are needed. The investigators believe either of these approaches would be preferred by less     experienced endoscopists to precut papillotomy. Consequently, it is important to     differentiate these techniques and identify which patients may benefit from one or both.   "
233870|NCT00919087|"     This is a prospective, single center, non-randomized study to evaluate the arrhythmia     detection performance during ventricular events.   "
233871|NCT00919100|"     A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of     cannulation when compared to vapocoolant spray.   "
233872|NCT00919113|"     A new device for interstitial cystitis is compared to inactive control to determine if it is     safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.   "
233873|NCT00919126|"     The purpose of this study is to evaluate the quantity of propofol administered with Xenon in     two inspiratory concentrations, to maintain comparable depth of anaesthesia during the     maintenance period of general anaesthesia.   "
233874|NCT00919139|"     RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer     to study in the laboratory may help doctors find better ways to ways to treat the cancer.      PURPOSE: The purpose of this study is to collect and store blood and bone marrow samples from     patients with multiple myeloma, smoldering myeloma, Waldenstrom's macroglobulinemia,     amyloidosis, and monoclonal gammopathy of undetermined significance to be tested in the     laboratory.   "
233875|NCT00919152|"     This study will be a retrospective electronic medical chart review of all patients admitted     to adult intensive care medicine units (ICU) at The Nebraska Medical Center over a three-year     period from January 2006 through December 2008. The study will have three primary aims:        -  Aim 1: Determine correlates (qualifying criteria) of patients initiated on enteral          versus parenteral PPIs as first choice in ICU and after discharge from ICU,        -  Aim 2: Based on correlates determine number of patients receiving parenteral PPIs that          could receive enteral therapy as first choice in ICU and after discharge from ICU,        -  Aim 3: Estimate the potential savings in drug costs associated with conversion of          eligible patients from parenteral to enteral PPI therapy with emphasis on lansoprazole          solutab in the ICU and conversion of eligible patients requiring continued AST from          parenteral to enteral PPI therapy after discharge from ICU.   "
233876|NCT00919165|"     To determine the effect of carotid artery stenting, on cognitive function, in patients with     high grade carotid artery stenosis   "
233877|NCT00919178|"     Infection with dengue viruses is one of the leading causes of hospitalization and death in     children in several tropical Asian counties. The World Health Organization (WHO) estimates     that these viruses are responsible for more than 50 million cases of dengue fever (DF) and     approximately 0.5 million cases of the more severe disease, dengue hemorrhagic fever/ shock     syndrome (DHF/DSS) annually. Because dengue viruses are endemic in most tropical and     subtropical regions, keeping more than 2 billion persons at risk for acquiring dengue, the     WHO has made development of a dengue vaccine a top priority.      The purpose of this study is to evaluate the safety and effectiveness of a candidate DEN4     vaccine aimed at preventing infection with dengue virus serotype 4.   "
233878|NCT00919191|"     A study to compare the skin irritation potential of two marketed gels for acne treatment,     each applied to half of the face of healthy volunteers.   "
233879|NCT00919204|"     As part of the global clinical development program for AG-013736, studies are ongoing (and     planned) in cancer patients in China. An assessment of AG-013736 pharmacokinetics in Chinese     subjects, as required by the Chinese Health Authorities, is therefore warranted.      In the current study the single dose pharmacokinetics of AG-013736 will be characterized at 3     doses (5 mg, 7 mg and 10 mg).   "
233880|NCT00919217|"     The investigators' overall hypothesis is that appearance or worsening of relapsing-remitting     multiple sclerosis (RR-MS) symptoms are affected by various factors including stress,     hormonal cycles, illness and missed medications.   "
233881|NCT00919230|"     At present our current practice is to provide a course of oral iron therapy for those     patients with a post-operative haemoglobin which is below normal, but not severe enough to     require a blood transfusion. Such a practice is not without side effects from the iron     tablets, namely ingestion, nausea, diarrhoea, constipation. There is little evidence in the     literature to support the current practice of using iron, with only one small randomised     trial suggesting such therapy is unnecessary. We propose to recruit 300 patients recovering     from a hip fracture with a post-operative haemoglobin below 11g/l. For those patients willing     to enter the study, half will be given oral iron therapy (ferrous sulphate 200mg twice daily)     for one month. The haemoglobin will be checked when the patients attends the hip fracture     clinic at 6 weeks after discharge.   "
233882|NCT00919243|"     Hyperuricemia is a very common finding in patients with heart failure. It is usually related     to diuretic use and deteriorated renal function. The recently evidence showed that uric acid     (UA) lowering therapy may improve clinical status in symptomatic heart failure patients with     hyperuricemia. In their clinical practice, the investigators found that glucocorticoids could     dramatically lower UA while improving renal function. Thus the investigators design this     randomized head to head study to test our hypothesis that prednisone have the same efficacy     to allopurinol on lowering UA and could improve renal function at the same time.   "
233885|NCT00919295|"     This study aims to investigate the anti-nociceptive biogenic amine (serotonin     [5-hydroxytryptamine; 5-HT], norepinephrine [NE], dopamine [DA], and their metabolites)     status, and serum levels of cytokines, BDNF and BH4 in Thai fibromyalgia syndrome (FMS)     patients compared with a representative Thai population. The efficacy and the tolerability of     mirtazapine as monotherapy for FMS will also be assessed. In addition, proof of concept of     the indoleamine 2,3-dioxygenase (IDO) activity in FMS will be conducted.      The study will be divided into three parts. In part I, FMS patients of Thai ethnicity will be     examined to determine the blood and/or urinary level of anti-nociceptive biogenic amines,     cytokines, BDNF and BH4 by comparison with the demographically matched, but unrelated,     healthy normal controls (HNC). In part II, the FMS subjects from part I study will be     randomized to blinded therapy with mirtazapine or identical appearing placebo. There will be     three treatment groups (N=1:1:1) to accommodate two dosages of mirtazapine (15 mg, 30mg) and     placebo given before bedtime. Pill counts at baseline and at follow-up visits will document     compliance. Standard outcome instruments (translated and validated in Thai language) will be     used at baseline and at each of the follow-up visits. The co-primary outcome variable will be     the changes in the pain visual analog scale (PVAS) score and pain responders (>= 30% PVAS     reduction). Secondary clinical outcome variables of interest will include depression,     insomnia, anxiety, physical function, morning stiffness, patient global assessment of disease     status, patient global impression of change, fibromyalgia impact questionnaire (FIQ, quality     of life and adverse experience. The changes of biogenic amine and IGF-1 concentrations in     blood and/or urine with the treatment will be examined as the secondary biochemical measures.     In part III, the IDO activity of depressed FMS, non-depressed FMS and HNC will be compared.     Moreover, the effect of mirtazapine treatment on the IDO activity in depressed and     non-depressed FMS patients will be assessed.      Study hypothesis        1. Anti-nociceptive biogenic amine levels in Thai FMS patients are lower than in Thai          healthy normal control.        2. Higher IDO activity could be observed in FMS patients.        3. Higher cytokines could be observed in FMS patients.        4. Higher BDNF could be observed in FMS patients.        5. Lower BH4 could be observed in FMS patients.        6. Mirtazapine is effective in FMS treatment.   "
233886|NCT00919308|"     Hypothesis #1: Residents who complete a structured, ultrasound guided simulation training     protocol will have superior skills at central venous catheter (CVC) insertion on actual     patients as compared to residents who are trained in CVC insertion according to the     traditional, bedside apprenticeship model as measured by a reduced failure rate at CVC     insertion.      Hypothesis #2: Residents who complete a structured, ultrasound guided simulation training     protocol will have superior skills at CVC insertion on actual patients as compared to     residents who are trained in CVC insertion according to the traditional, bedside     apprenticeship model as measured by:        1. a reduced number of attempts at venous cannulation,        2. a decreased rate of technical errors and a decreased complication rate based on an          independent rater's evaluation using a procedure checklist, and        3. a decreased time to CVC insertion from opening the catheter kit to placement of sterile          dressing as timed by an independent rater.   "
233887|NCT00919321|"     Patients with chronic lymphocytic leukemia (CLL)have had very poor humoral responses to     pneumococcal polysaccharide vaccine (PPV). The vaccine in which pneumococcal polysaccharide     antigens are conjugated to protein (PCV) have been immunogenic in CLL patients in our     previous studies.      The purpose of this study is to evaluate the duration of these vaccine-induced antibodies and     the function of memory cells by giving a one dose of PPV-vaccine after several years of     PCV-vaccination.   "
233888|NCT00919334|"     To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression     in Hong Kong schoolchildren using simultaneous vision approach.   "
233889|NCT00919347|"     The purpose of this study is to measure the prevalence and severity of cardiac autonomic     neuropathy (CAN), diabetic autonomic neuropathy (DAN) which in non-diabetics is termed     advanced nervous system (ANS) dysfunction, and autonomic dysfunction as well as the overall     sympathovagal balance (SB) in the CEFH population of diabetic patients versus non-diabetic     patients undergoing elective vitreoretinal surgery.   "
233890|NCT00919360|"     The purpose of this study is to figure out some of the differences in bodily function between     women who have preeclampsia and those who do not.        -  This may eventually lead to an understanding of its cause. At this time, there is no          known way to prevent preeclampsia, and the cause is not known.        -  The only treatment is delivery of the baby, even if it is premature, in order to          decrease the risk to the mother.   "
233891|NCT00919373|"     The main objective of this study is to compare the time from randomization to the first     recurrence of any ventricular tachycardia (VT) in patients undergoing VT ablation (for stable     VTs) and substrate ablation (for unstable VTs) after an initial episode of stable VT and     patients not undergoing ablation, with both groups under the protection of an ICD.   "
233892|NCT00919386|"     To examine a patient's quality of life using three methods for measuring stent size: (a)     direct measurement, (b) patient height, and (c) a standardized formula. The intent of the     study is to show if there is a difference in a patient's quality of life, postoperative     symptoms, pain medication and anticholinergic use by using one of these specific methods for     stent size determination. No method is interventional in this study.   "
233893|NCT00919399|"     This is a Phase II non-randomized, open, uncontrolled and bi-centric study of hormonal     induction by exemestane (Aromasin) + tamoxifen to evaluate the effectiveness of exemestane     (Aromasin) with tamoxifen on the rate of clinical response menopausal in patients with tumors     of locally advanced breast. Hormone therapy will be administered at a dose of 25mg/day for     exemestane and 20 mg / day for 4 months for tamoxifen.   "
233894|NCT00919412|"     The goal of this study is to identify a non-invasive predictor or predictors that will     increase the clinician's ability to identify patients with preterm labor (PTL) at risk for     preterm delivery (PTD). Through these studies we also hope to reveal potential therapeutic     targets in the prevention of prevention of preterm births.      The study hypothesis is that we can identify non-invasive predictors of PTL at risk for PTD.   "
233895|NCT00919425|"     RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer     to study in the laboratory may help doctors learn more about diagnosing cancer and how well     patients will respond to treatment.      PURPOSE: The purpose of this study is to collect and store blood and bone marrow samples from     patients with hematologic cancer to be tested in the laboratory.   "
233896|NCT00919438|"     This is a single center, non randomized study to gather data to correlate physiological     signals with the patient's fluid status during fluid removal in hemodialysis.   "
233897|NCT00919451|"     Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy      Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line     drug in patients with Type 1 Reactions who have not responded to a 12 week course of     Prednisolone.   "
233898|NCT00919464|"     This study is to determine the natural history of compartment pressures in the anterior thigh     secondary to a fracture of the femoral shaft.   "
233901|NCT00919503|"     This phase II clinical trial studies how well treosulfan and fludarabine phosphate with or     without low dose radiation before donor stem cell transplantation works in treating patients     with nonmalignant (noncancerous) diseases. Hematopoietic cell transplantation has been shown     to be curative for many patients with nonmalignant (noncancerous) diseases such as primary     immunodeficiency disorders, bone marrow failure syndromes, hemoglobinopathies, and inborn     errors of metabolism (metabolic disorders). Powerful chemotherapy drugs and/or radiation are     often used to condition the patient before infusion of the new healthy donor cells. The     purpose of the conditioning therapy is to destroy the patient's abnormal bone marrow which     doesn't work properly in order to make way for the new healthy donor cells which functions     normally. Although effective in curing the patient's disease, many hematopoietic cell     transplantation regimens use intensive chemotherapy and/or radiation which can be quite     toxic, have significant side effects, and can potentially be life-threatening. Investigators     are investigating whether a new conditioning regimen that uses less intensive drugs     (treosulfan and fludarabine phosphate) with or without low dose radiation results in new     blood-forming cells (engraftment) of the new donor cells without increased toxicities in     patients with nonmalignant (noncancerous) diseases.   "
233902|NCT00919516|"     The purpose of this study is to evaluate the efficacy of dual intramuscular and     intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of     patients with moderate to severe peripheral arterial disease in whom amputation was     considered the only viable treatment option.      Study Hypothesis: Patients with moderate to severe peripheral arterial disease who receive     intramuscular and intra-arterial stem cell injections will have improved ankle brachial index     (ABI) measurements; relief of rest pain; ulcer healing, if applicable; and absence of major     limb amputations.   "
233903|NCT00919542|"     Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum      Objective: A pilot (double blind controlled) study randomizing patients to treatment either     with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of     Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).   "
233904|NCT00919555|"     The purpose of the study is to determine the safety and the efficacy of Tretinoin and     Pioglitazone HCL in patients with ALS who are currently on Riluzole.   "
233905|NCT00919568|"     Prospective, multicenter, non-randomized study to determine the performance of NUVANT Mobile     Cardiac Telemetry system in arrhythmia detection.   "
233906|NCT00919581|"     The purpose of the study is to investigate inflammatory and other substances that may be     elevated in the blood and blood cells following spinal cord injury (SCI). These substances     will be evaluated in samples from people who have had a spinal cord injury due to trauma     (e.g. car accident or a fall) within the first week (acute) or at least one year ago     (chronic). Specifically, the study will evaluate the presence and levels of a protein,     macrophage migration inhibitory factor (MIF). MIF is released by cells and has a specific     effect on the way cells behave, communicate and work together. In several other medical     conditions, MIF is known to increase inflammation in the body. By comparing blood samples     from individuals with spinal cord injury and uninjured (no spinal cord injury) individuals,     the investigators will try to find out if MIF levels are increased in people with SCI.     Investigators will also use these samples to measure other proteins that increase     inflammation in the body and to see if the biological activities of MIF can be reduced in a     test tube by adding other substances to the blood samples. It is hoped that this study of MIF     and other proteins related to inflammation will help improve the treatment of SCI in the     future.      We hope to enroll a total of 312 subjects in this study (50 with acute spinal cord injury,     125 with chronic spinal cord injury, and 137 uninjured individuals).   "
233907|NCT00919594|"     The current proposal is a randomized, controlled, clinical trial to evaluate the     intergenerational impact of treating depressed mothers whose children suffer from psychiatric     disorders.   "
233908|NCT00919607|"     The primary objective of the study is to evaluate the pharmacokinetics of XR quetiapine     fumarate(300mg,600mg,and 800mg once-daily) in Chinese schizophrenic patients .   "
233909|NCT00919620|"     One of the commonly adopted strategies in improving outcome in psychotic disorders is by     focused, specific and intensive intervention in the initial few years of the disorder.     However the effects of intervention and the optimal duration of intervention have seldom been     examined in randomized studies. This study uses a randomized controlled study design to     investigate the effectiveness of stage-specific case-management in improving outcome of first     episode psychotic disorders. It also addresses whether two years of case-management is less     effective than four years of case-management over a four year period. A total of 500     subjects, who aged 25 or above, and diagnosed with first episode psychotic disorders, will be     and randomized into 3 groups: (1) standard care alone without case management, (2) two-year     case management, (3) four-year case management. All groups will receive usual standard care     treatment. This four-year follow-up study will assess symptoms, functioning, quality of life     as well as health economics data.   "
233910|NCT00919633|"     The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon     alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a     safe and effective treatment for patients with chronic hepatitis C infection as compared to     patients who receive standard treatment.   "
233911|NCT00919646|"     This is a prospective, single center, non-randomized study to evaluate the arrhythmia     monitoring performance of the AVIVO™ System in a hospital setting.   "
233928|NCT00919880|"     The purpose of this study is to determine whether neo-adjuvant weekly paclitaxel with     carboplatin is better than paclitaxel alone in efficiency and safety in early breast cancer,     and to explore whether ultrasound and magnetic resonance imaging can predict the efficiency     of neo-adjuvant chemotherapy.   "
233929|NCT00919893|"     In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen     extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was     investigated. The purpose of this study is to determine whether Cernilton is safe and     effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.   "
233930|NCT00919906|"     This study will assess whether a computer haptic peripheral device programmed to provide     repetitive motion training is as effective as the same repetitive motion training provided by     a human being.   "
233913|NCT00919672|"     Sacral nerve stimulation (SNS) has become a well-established treatment for patients with     fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood     but recent studies have shown that the motility of the whole colon is modulated during the     stimulation. This modulation of the colonic motility could be a potential mechanism of an     action to relieve the symptoms in patients with IBS.      Twenty eight patients with IBS will be enrolled in the study. They have to meet the ROME III     criteria, and also satisfy the criteria for implantation of a neurostimulator.      After a post implantation period where the programming of the neurostimulator is optimised,     the patient is randomized in a double blinded design to receive either ON-OFF or OFF-ON     stimulation in a 2-month period.      At the end of each period (ON/OFF) the patient will be examined with Magnet Tracking System     (MTS) for motility and with impedance planimetry including thermal stimulation (circulating     water)for multimodal sensory testing of the rectum.      This is based on the study hypothesis that the motility of the small intestine and the colon     is changed in IBS patients according to their subtype (Diarrhoea-IBS, Constipation-IBS and     Disordered bowel habit-IBS) compared to healthy persons. And that SNS will affect the     motility of the small intestine and the colon in IBS patients as well as SNS will affect the     perception of pain/discomfort in the rectum in IBS patients.      The effect of ON-OFF-sacral nerve stimulation on the IBS patients and thereby their IBS     symptoms will also be evaluated by an IBS score (GSRS-IBS)and on quality of life by an IBS     Impact Scale (IBS-IS) as well as the significance of placebo effect in the treatment of     patients with IBS with SNS will be evaluated.   "
233914|NCT00919685|"     Shock is a severe deficiency in oxygen at the cell level which could lead to the death.The     study was aimed at finding markers of treatment response in patients with shock, with a     better accuracy than that of lactate actually used : hypoxia-inducible factor (HIF),     circulating DNA (cDNA), and plasma from cells (MPs).   "
233915|NCT00919698|"     The overall purpose of this trial is to assess the relationship between a daily awakening     from sedation and the prevalence of delirium, and in doing so better characterize delirium in     the ICU.   "
233916|NCT00919711|"     A randomized, open label study to assess the safety and effectiveness of Denosumab,     administered every 6 months and Actonel ® (Risedronate), administered monthly in post     menopausal women transitioned from weekly or daily Alendronate therapy.   "
233917|NCT00919724|"     The blood vessels that carry blood from the heart to the rest of the body are normally     capable of relaxing and constricting when needed to provide more or less blood to the body.     The inability of blood vessels to relax and widen may increase the risk of heart disease and     stroke. One potential cause of this inability is inflammation. Because HIV infection is     associated with inflammation, it is possible that the blood vessels in people infected with     HIV may not relax properly. The purpose of this study is to determine whether people infected     with HIV have worse blood vessel function than people without HIV infection.   "
233918|NCT00919737|"     The purpose of this study is to evaluate whether NPC-08 is safety and efficacy in the     treatment of newly-diagnosed malignant glioma and recurrent glioblastoma multiforme.   "
233919|NCT00919750|"     The purpose of this study is to collect and store brain tissue samples and blood from     children with brain cancer that will be tested in the laboratory. Collecting and storing     samples of tumor tissue and blood from patients to test in the laboratory may help the study     of cancer in the future.   "
233920|NCT00919763|"     This is a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives:     To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus     its vehicle in adult subjects with at least moderate atopic dermatitis.      Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over     4 weeks versus its vehicle on 5% - 20% involved BSA (excluding Head/Neck) in adult subjects     with at least moderate atopic dermatitis.   "
233921|NCT00919776|"     Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum     Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of     patients whose ENL is not controlled with standard Prednisolone.      Objective: A pilot double blind controlled study randomizing patients whose ENL is not     controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a     group treated with additional steroid only.   "
233922|NCT00919802|"     Anecdotal evidence suggests female patients with painful bladder disorder interstitial     cystitis (IC) can experience a significant attenuation of their systems while breastfeeding.     Since it has been shown that postpartum lactation is a time associated with decreased levels     of stress, and stress has been shown to exacerbate IC-related pain, the investigators have     developed an interest in the effects of the hormones involved in postpartum lactation on     stress and pain. Based on a series of pre-clinical experiments, the investigators believe the     hormone oxytoxin has both analgesic and anxiolytic properties which make it a potentially     useful agent for the treatment of stress-exacerbated chronic pain syndrome such as IC.     Therefore, the investigators propose a double-blinded, placebo-controlled crossover trial of     intranasal oxytocin vs. intranasal saline for bladder pain in a cohort of patients with IC     and some degree of continuous, daily pain.   "
233923|NCT00919815|"     Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy      Objective: A randomised double blind controlled trial comparing Ciclosporin and     Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the     treatment of new Type 1 Reactions as Prednisolone.   "
233924|NCT00919828|"     This is a prospective, multi-center, non-randomized study to evaluate performance of an     external monitor for heart failure patients   "
233925|NCT00919841|"     Women who naturally deliver a singleton will be invited to participate the study. Weekly     transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus     is completely involuted. The pattern of involution will be analyzed.   "
233926|NCT00919854|"     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the     medication), safety and antiviral activity to support dose recommendations by body weight of     darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs     (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.   "
233927|NCT00919867|"     Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE     (lisdexamfetamine dimesylate) when given alone, and in combination.   "
233931|NCT00919919|"     The objective of the study is to confirm that the efficacy of vaginal progesterone is at     least as good as oral progesterone in order to protect the endometrium of uncontrolled     proliferation and prevent endometrial cancer.   "
233932|NCT00919932|"     The primary goal of the pilot is to test the feasibility and utility of using a     text-messaging system to engage adolescents in improved homework adherence during     cognitive-behavioral therapy (CBT) for major depressive disorder.   "
233933|NCT00919945|"     The objective of this study is to determine the impact of early post-operative feeding on     splanchnic blood flow, cardiac output and end organ perfusion, and the patients overall     clinical outcomes.   "
233934|NCT00919958|"     The The purpose of this study is to determine the safety of PLX-PAD single dose,     Intra-muscular injection for the treatment of CLI patients.   "
233935|NCT00919971|"     To evaluate the effectiveness of use of the bispectral index for monitoring of depth of     sedation in ventilated patients during their prehospital management by a physician- staffed     EMS. Hypothesis: there is a correlation between BIS and sedation scores.   "
233936|NCT00919984|"     Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy     is recommended for all patients with advanced ovarian cancer.      Traditionally, intravenous paclitaxel + carboplatin has been the standard adjuvant therapy.      Recently, intraperitoneal combination chemotherapy has been reported to be effective in     ovarian cancer.      We attempted to evaluate the efficacy and feasibility of standard intravenous paclitaxel +     carboplatin plus intraperitoneal paclitaxel chemotherapy.   "
233937|NCT00919997|"     RATIONALE: Gathering information about human papilloma virus (HPV) infection in HIV-positive     men who have sex with men may help doctors learn more about the disease.      PURPOSE: This clinical trial is studying HPV infection in HIV-positive Indian men who have     sex with men.   "
233938|NCT00920010|"     RATIONALE: Collecting and storing samples of tissue, blood, and sputum from patients with     cancer to study in the laboratory may help the study of cancer in the future.      PURPOSE: The purpose of this study is to collect and store tissue, blood, and sputum samples     from patients with lung cancer to be tested in the laboratory.   "
233939|NCT00920023|"     The purpose of this research study is to see if a specific kind of MRI, called Ultrasmall     Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), which uses an     FDA-approved therapeutic agent(Feraheme) to see if it is able to identify small and otherwise     undetectable lymph node metastases in people who have pancreatic cancer and are scheduled for     surgical resection.   "
233940|NCT00920036|"     Objective:      The aims are to examine the feasibility and acceptability of a handheld biofeedback device as     an adjunct treatment for Post Traumatic Stress Disorder (PTSD) and to estimate its clinical     effect size. A recent summary of 22 studies on OIF/OEF (Operation Iraqi Freedom/Operation     Enduring Freedom) veterans revealed that many individual and system factors (e.g., stigma,     concern about promotion/employment, lack of providers) prevented access to mental health     services. For veterans who did seek help, the largest treatment trials of pharmacologic,     outpatient psychotherapy, and residential treatment programs were not very effective.     Currently, prolonged exposure therapy is the most validated PTSD treatment. The VHA enrollees     from OIF/OEF are more likely to live in rural areas, hindering them from pursuing treatment     due to travel distance and time commitment. Thus, new treatments and delivery methods are     urgently needed.      A substantial body of preclinical literature documents autonomic nervous system (ANS)     dysregulation in patients with PTSD. Preliminary results suggest that portable heart rate     variability (HRV)/respiratory sinus arrhythmia (RSA) biofeedback is a promising adjunct     treatment for autonomic arousal disorders. The StressEraser, a HRV/RSA biofeedback device, is     indicated for relaxation, relaxation training, and stress reduction. This small handheld     device measures and displays real-time RSA via an infrared finger sensor.      Research Plan:      The investigators were able to randomize 16 OIF/OEF veterans receiving care for PTSD at CAVHS     community-based outpatient clinics (CBOCs) to a 24-week course of StressEraser use (N=8)     versus usual care (N=8). A trouble-shooting phone call to participants occurred at 6 weeks.     Follow-up clinical assessments occurred at 12 and 24 weeks.      Methods:      The baseline assessment consisted of a screening interview for comorbid anxiety and substance     use disorders, the Clinician Administered PTSD Scale (CAPS), the 9-item depression Patient     Health Questionnaire (PHQ-9), and a quality of life measure (Quality of Well-Being Scale-Self     Administered [QWB-SA]). In addition, psychophysiologic assessment of reactivity and     attentional bias to combat-related PTSD relevant stimuli occurred through virtual reality     (VR) and acoustic startle stimuli at the North Little Rock psychophysiologic reactivity lab.     The StressEraser group was trained to operate the device at baseline and instructed to use it     for 5-20 minutes daily before bedtime for 24 weeks.      At six weeks, a research assistant phoned the StressEraser group to address any problems with     the device and the usual care group to insure adherence with ongoing treatment. The 12-week     assessment involved phoning both groups to administer the psychometric measures (CAPS, PHQ-9,     and QWB-SA). At 24 weeks, the sample returned to the lab for administration of the     psychometric measures and assessment of psychophysiologic reactivity.      The subjects in the StressEraser group returned the device. The time spent using the     StressEraser and the total number of resonant frequency respirations were the feasibility     measures. The StressEraser logged the date, time, and duration of use and the amount of     resonant frequency breathing, which is the resonance between the respiratory and baroreflex     rhythms, the two primary sources of cardiac stimulation. Acceptability was measured through a     short debriefing interview.   "
233941|NCT00920049|"     Background:        -  Automobile crash risks are highest right after licensure and decline rapidly for about 6          months and then gradually for years, regardless of the amount of supervised practice          driving or age at licensure. The only approaches to this problem that have demonstrated          effectiveness are Graduated Driver Licensing (GDL) and parental management.        -  The Checkpoints Program consists of persuasive messages and materials designed to          increase adoption of the Checkpoints Parent-Teen Driving Agreement and to improve          parents' ability to set limits on higher-risk driving privileges for novice drivers.          Researchers are interested in determining whether expanding the Checkpoints Program to          an online version (instead of through the mail) can help improve parent limit-setting in          connection with the program.      Objectives:        -  To determine the feasibility and effectiveness of conducting an online version of the          Checkpoints Program through American Automobile Association (AAA) clubs.        -  To test rates of parental intervention and limit-setting after participation in the          Checkpoints Program.      Eligibility:      - Parents whose teenage children are enrolled in AAA-affiliated driving schools.      Design:        -  Parents with children at the permit stage of driver's education will be recruited          through AAA clubs and will be asked to visit a designated Web site to sign up for the          program.        -  Parents will provide consent and complete the baseline survey, and will be assigned to          random groups to test different versions of the Checkpoints Program (the intervention or          a control group Web site).        -  The intervention program will contain videos, regular e-mails, and newsletters on          setting parental limits and information on specific teen driving risks. The control          program will provide information on various topics related to the licensing procedure          and safe driving, but no specific information on teen driving risks.        -  A follow-up assessment will be conducted 1 month after the teenager receives his or her          license.   "
233942|NCT00920062|"     This study is to test the usefulness of ultrasound dilution recirculation measurements in     patients receiving venovenous extracorporeal membrane oxygenation as therapy. The ultrasound     dilution measurements determine the efficiency of support provided by venovenous     extracorporeal membrane oxygenation. At the present time there are no other devices available     to make recirculation measurements.   "
233943|NCT00920075|"     The investigators earlier have shown that treatment of patients with juvenile osteoporosis     with alendronate (Fosamax) for 12 months increased the bone density without side effects. In     an open label study (10 patients) and double blind, crossover study (11 patients alendronate     and 11 patients placebo), the investigators have further observed that alendronate increased     the bone density significantly where as placebo (calcium and vitamin D) increased only     minimally. These trials were completed. Thus, a post study is designed to evaluate the     current status of the bone density and fractures after the patients discontinued the     alendronate treatment. No treatment is involved.   "
233944|NCT00920088|"     The purpose of this study is to evaluate the effect of GSK2448761 on CYP450 metabolic probes     and to evaluate the 2-way interaction between GSK2448761 and two ritonavir-boosted protease     inhibitors that are commonly used in HIV-infected subjects.   "
233945|NCT00920101|"     The purpose of this study is to determine whether HMG-CoA reductase inhibitor, atorvastatin     attenuates inflammation in atherosclerotic plaques detected by 18F-fluorodeoxyglucose(FDG)     PET.   "
233982|NCT00920582|"     The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead     to greater reductions in insulin requirements in conjunction with near normal blood sugar     control compared to placebo in patients recently diagnosed with type 1 diabetes.   "
233946|NCT00920114|"     Lupus erythematosus systemic is an auto-immune disease the evaluation of the activity of     which remains very difficult because of an heterogeneousness of the clinical and biological     symptoms. The aim of this study is to develop objective, specific and not invasive methods of     evaluation of the activity and the forecast of the disease by using an analysis of the     transcriptome on circulating blood. A transcriptomic analysis will be realized in parallel by     the usual clinico-biological follow-up at the patients affected by systemic lupus, while the     diagnosis before treatment, then during every revaluation of the disease during the period of     the study. The already treated patients can also be included in this study.   "
234000|NCT00910507|"     The purpose of this randomized clinical trial is to investigate the impact of physical     therapist-directed exercise counseling combined with fitness center-based exercise training     on stage of exercise behavior in people with type 2 diabetes.   "
233947|NCT00920127|"     Obstructive airways disease is a very common condition. This condition includes patients with     asthma, chronic obstructive pulmonary disease (COPD), emphysema or chronic bronchitis. Some     patients with obstructive airways disease have problems with long term breathlessness, wheeze     and cough with or without sputum production. Currently the researchers give treatments -     usually inhalers - which are designed to open the airways and reduce the breathlessness and     wheeze. Despite these available treatments many patients still have continuing symptoms.      Anecdotal clinical evidence suggested that a herbal remedy (called AKL1) has beneficial     effects in respiratory conditions, with patients diagnosed as having both asthma and COPD     reporting reduced symptoms including breathlessness and cough and reduced frequency of     attacks.The purpose of this study is to confirm whether AKL1 does indeed have a meaningful     benefit to patients with obstructive airways disease. The researchers will mainly be     measuring any effect of AKL by assessing any change in trial subjects' coughs, using a     questionnaire, but the researchers will also looking at breathing tests, walking tests, blood     and sputum tests.   "
233948|NCT00920140|"     MEK111759 is a dose-escalation, Phase I/II, open-label study to determine the recommended     dose and regimen for the orally administered MEK inhibitor GSK1120212 in subjects with     relapsed or refractory leukemias. The recommended dose and regimen will be selected based on     the safety, pharmacokinetic, and pharmacodynamic profiles. This study will identify the     maximum tolerated and recommended Phase II doses using a dose-escalation procedure. Dose     escalations will continue based on predefined parameters until a maximum tolerated dose is     established. In Phase II, the clinical efficacy of GSK1120212 in subjects with relapsed or     refractory leukaemias (AML, MDS or CMML) will be determined.   "
233949|NCT00920153|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving drugs in     different combinations may kill more cancer cells. It is not yet know which treatment regimen     is more effective in treating Hodgkin lymphoma.      PURPOSE: This phase III trial is studying three different therapy regimens to compare how     well they work in treating patients with previously untreated Hodgkin lymphoma.   "
233950|NCT00920166|"     The purpose of the study is to assess growth and tolerance in new born and infant fed an     experimental infant formula with reduced total protein concentration, enriched in     alpha-lactalbumin and containing a symbiotic.   "
233951|NCT00920179|"     Traditional methodological clinical and instrumental diagnostics of the lacrimal gland for     the study of glandular architecture and functions are limited and include analysis of tear     constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and     histopathological evaluation of lacrimal gland biopsy specimens. Confocal microscopy is a new     emerging technology which is useful as a supplementary diagnostic tool for in vivo assessment     of anterior-segment disorders.The use of in vivo confocal microscopy in a comparative study     of the microscopic morphology of the salivary/lacrimal glands have not been reported up to     date. In this study, we employ laser scanning confocal microscopy to evaluate the     morphological changes of the salivary/lacrimal glands in patients with primary Sjögren's     syndrome and compare the results with those of healthy control subjects.   "
233952|NCT00920192|"     The purpose of this study is to assess the safety and tolerability of foretinib (also known     as GSK1363089) when used in the treatment of patients with advanced hepatocellular carcinoma     (liver cancer).   "
233953|NCT00920205|"     The purpose of this study is to see how safe the study drug is and to determine the best dose     to use in cancer patients in the future.      The study drug is designed to reduce the activity of a protein known as heat shock protein     90, or Hsp90. Hsp90 is found in every cell in the human body and normally helps those     cells (and the body) cope with stressful situations. In certain cancers, however, Hsp90 helps     the cancer cells survive and grow. By reducing the activity of Hsp90, the study drug may slow     the growth, and reduce the survival, of those cancer cells.   "
233954|NCT00920218|"     The purpose of this observer-blind study is to evaluate the safety and immunogenicity of     GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when     administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.   "
233955|NCT00920231|"     This is a feasibility study involving a small number of blind subject to evaluate the     effectiveness of using a software and associated hardware components to assist the blind in     identifying and locating objects of interests and to assist in way finding tasks. After the     system has been successfully tested by the blindfolded engineers, it will be evaluated in a     small number of blind subjects.   "
233956|NCT00920244|"     The purpose of this study is to analyse transitions in cardiac rhythm and hemodynamic     variables during resuscitation of patients with in-hospital cardiac arrest.   "
233957|NCT00920257|"     This study is a first time in human, Phase I, open-label, dose-escalation study of the oral     AKT inhibitor GSK2141795 in subjects with solid tumors or lymphomas.   "
233958|NCT00920270|"     Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram     Negative Bacteria should be more effective than conventional therapy   "
233959|NCT00920283|"     The COMPETE study is a prospective,randomized,two-arm multi-center clinical trial comparing     two commercially available coronary stents: Chrono Carbostent Carbofilm™ Coated vs     Driver/Micro-Driver Coronary Stent System. In this study, 204 subjects will be included (2:1     randomization Chrono:Driver/Micro Driver) in 6 Italian sites.   "
233960|NCT00920296|"     The primary objective of this study is to compare steady-state plasma PK, safety and     tolerability of GSK1265744 with and without etravirine   "
233961|NCT00920309|"     Currently the only approved use for rapamycin (sirolimus) is for immunosuppression after     renal transplantation.      This trial is designed to determine whether rapamycin is safe and effective treatment for     patients with polycystic kidney disease (ADPKD). Patients will be followed by volumetric     magnetic resonance imaging (MRI) to observe for change in kidney (and cyst) size. Blood and     urine samples will also be collected to evaluate for change in biomarkers with treatment.   "
234001|NCT00910520|"     The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A     (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary     incontinence.   "
234002|NCT00910533|"     The purpose of this study is to determine clinical course and the sequelae of early Lyme     neuroborreliosis after treatment with ceftriaxone.   "
233962|NCT00920322|"     This study will report on the outcomes of rTMS administered 3 times per week, compared with     the standard protocol of 5 times per week. Participants will be randomly assigned to     frequency condition and depressive symptomatology will be measured weekly using a range of     clinician and self-rated questionnaires. Participants will remain in the study for at least 4     weeks, with the option of continuing for a further 2 weeks as judged by the study     psychiatrist. It is hypothesised that rTMS administered three times per week will be equally     as effective as rTMS administered five times per week in reducing depressive symptomatology.   "
233963|NCT00920335|"     Adult intracranial ependymoma is a relatively rare brain tumour entity, accounting for 2-5%     of all intracranial neoplasms. The pertinent prognostic factors as well as the pattern of     recurrence remain to be elucidated. According to several recent reports, the prognostic value     of Karnofski performance status, tumour location, the extent of surgical removal,     histological grade and even postoperative radiotherapy remain controversial. As a     consequence, optimal therapeutic management of adult intracranial ependymomas remains an     ongoing debate. For this reason, a retrospective study conducted by the French society of     neurosurgery (SFNC), neuropathology (SFNP) and the association of the neuro-oncologists of     French expression (ANOCEF) was undertaken and allowed to collect 258 cases coming from 25     centers, initially diagnosed as intracranial ependymomas between 1990 and 2004. Clinical and     follow-up data of these patients are known and the paraffin embedded samples as well as the     frozen tissues available have been centralized. Central pathological review of these 258     cases was conducted by two senior neuropathologists and confirmed the diagnosis of ependymoma     in 152 cases, thus constituting the most important series of the literature. Few molecular     studies were carried out on ependymomas. The investigators have the opportunity, based on     this important series, to determine the clinicopathological criteria and the molecular     markers who will allow a better characterization of the diagnosis and the prognosis of these     tumors.   "
233964|NCT00920348|"     Abstract Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in     Canada. COPD is not just a disease of men, nor is it solely a disease in old age. Women have     been underrepresented and early disease has not been studied. Underdiagnosis of COPD remains     a significant problem, and it may indicate an unmet healthcare need. This can potentially     results not only in a patient been misinformed, but can lead to incorrect management.      Epidemiological research is needed to develop a framework to combat this major health     problem, by better characterization of the population of men and women at risk and patients     with early disease, by better understanding which factors modifiable through health     interventions are related to health perception (health-related quality of life) and disease     evolution.      This will be possible through a nationwide study, the Canadian Cohort Obstructive Lung     disease (CanCOLD), a prospective longitudinal study. The CanCOLD study is built on the     current ongoing prevalence nationwide study, the Canadian Obstructive Lung disease COLD     study.      The CanCOLD will be the first study to assess prevalence of disease across Canada and its     consequence in men and women, and to evaluate a conceptual model of disease severity based on     patient's health perception (health-related quality of life). Ultimately, this project will     extend to a longitudinal follow up (3 years or beyond) and will allow to have a better     understanding of the lifestyle risk factors, not only smoking but also diet, physical     activity, and co morbid conditions. This will be a great asset to shift from management of a     single risk factor (tobacco control) to total COPD risk management. The results of the study     will greatly help to assist decision makers in developing policies to improve the diagnosis,     the management of COPD and to optimize health care services use.   "
233965|NCT00920361|"     To evaluate dosage and administration method, efficacy and safety of Puregon and the     relationship between background factors of patients and dose and administration method.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
233966|NCT00920374|"     This study is designed to test the immunogenicity and reactogenicity of the     FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for     the 2009-2010 season.   "
233967|NCT00920387|"     This study will find out whether psychotherapy combined with lysergic acid diethylamide (LSD)     is safe and is helpful in people who are anxious because they have a potentially fatal     disease. The study will measure anxiety and quality of life before and after people have two     sessions with either full or active placebo dose of LSD. They expect LSD-assisted     psychotherapy to reduce anxiety and improve quality of life.   "
233968|NCT00920400|"     Fecal calprotectin is a very sensitive non-invasive inflammation marker in the detection of     inflammatory bowel disease and, to a lesser degree, has also proven to be useful in     adenomatous polyps, neoplasias, and infectious gastroenteritis. Elevated calprotectin levels     can also be found in patients with lesion only in the upper gastrointestinal tract. However,     the diagnostic value of calprotectin has never been tested in this setting. The aim of the     study is therefore to determine the diagnostic value of fecal calprotectin in patients with     diseases of the upper gastrointestinal tract.   "
233969|NCT00920413|"     People with kidney failure are at risk for the development of anemia. Anemia is a decrease in     the production of hemoglobin, a substance that carries oxygen in the blood. The majority of     patients require erythropoietin and iron supplementation to correct the anemia. In some     patients, the hemoglobin fails to rise to a desired level despite treatment with     erythropoietin and iron. There have been several studies in hemodialysis patients showing     that vitamin C given intravenously helps to correct anemia in patients already on     erythropoietin and iron.      The purpose of this study is to determine whether oral vitamin C will improve parameters of     anemia in patients receiving peritoneal dialysis.      Description of the research      This is a randomized, double blind, placebo controlled study. Participants will be randomized     in a 1:1 ratio to oral vitamin C 500mg once a day or placebo for 3 months. All participants     will be receiving oral iron supplementation, subcutaneous erythropoietin and a B and C     complex vitamin containing 100mg of vitamin C. Lab parameters (hemoglobin, TSAT, ferritin)     will be done at baseline and then monthly. The primary outcome is percent change from     baseline in transferrin saturation. Secondary objectives are percent change in ferritin,     hemoglobin and erythropoietin dose from baseline.   "
233983|NCT00920595|"     An open-label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of     CEP-9722 as single-agent therapy and as combination therapy with temozolomide in patients     with advanced solid tumors.   "
233986|NCT00920634|"     The main purpose of this investigation is to collect information about safety and efficacy of     Follistim Injection from actual clinical use to induce ovulation in patients with anovulation     and oligoovulation due to hypothalamus-pituitary dysfunction.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
233970|NCT00920426|"     The purpose of this randomized, double-blinded study is to test the safety of GSK1265744 and     how well it works on reducing the amount of HIV in the blood. It will also look at how people     react to and how a human body uses GSK1265744. This study will compare the effects of     GSK1265744 and placebo.      The study will consist of 1 or 2 parts to look at doses of GSK1265744. About 8 people will     take part in Part 1 of the study receiving dose A. If additional dosing information is needed     after Part 1, about 6 people will take part in Part 2 of the study receiving dose B.   "
233971|NCT00920439|"     The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster     dose to Chinese children at 18-24 months of age.   "
233972|NCT00920452|"     The purpose of this study is to evaluate and document appropriate clinical performance of the     new 4-SITE Header / Lead interface in the TELIGEN 100 HE 4-SITE (VR and DR) implantable     cardioverter defibrillator (ICD) PGs (Models F103; F111), the COGNIS 100 HE 4-SITE cardiac     resynchronization therapy ICD (CRT-D) PG (Model P108) when connected to any of the RELIANCE     Quadripolar (4-SITE) defibrillation leads.      Appropriate clinical performance of system components of the 4-SITE systems other than the     new 4-SITE header / lead interface has been evaluated and documented already in the     previously conducted COGNIS and TELIGEN 100 HE FIELD FOLLOWING STUDY, The COGENT-4 Field     Following Study.      Data collected may be used to support international regulatory submissions including the FDA     and the Japanese Ministry of Health, Labour and Welfare.   "
233973|NCT00920465|"     The purpose of this study is to test two regimens of mifegyne and cytotec for medical     abortion. The investigators hypothesize that administration of both medications during one     hospital visit will not compromise effectiveness.   "
233974|NCT00920478|"     Patients with rheumatoid arthritis are at risk of developing permanent joint damage and     disability. This study hopes to identify the most effective way of using existing arthritis     medication to minimise the chances of developing permanent disability. Patients will have     their arthritis activity assessed using an ultrasound machine. If there is still evidence of     active arthritis the participant's arthritis medication will be increased until the arthritis     is in remission. The effectiveness of this approach will be compared to the traditional     method of assessing arthritis using clinical examination.      Furthermore, it is extremely important to identify those patients most at risk of aggressive     disease. The investigators hope to produce a more accurate measurement of disease prognosis     by examining the relationship between a series of blood tests and how well controlled     rheumatoid arthritis appears after 18 months of therapy. Some patients will also be asked to     donate samples of joint fluid and joint lining for additional analysis.   "
233975|NCT00920491|"     Patients presenting to emergency departments (ED) with non-specific complaints (NSC) such as     not feeling well, feeling weak, being tired, general deterioration are a very common     and well-known, but poorly studied patient group. The differential diagnosis of NSC is     extremely broad ranging from insufficient home care to acute life-threatening conditions.     Therefore, the evaluation and diagnostic work-up of these mostly elderly patients with NSC is     very time-consuming and not straight-forward. Furthermore, the assessment is complicated by     comorbidities, polypharmacy or an altered mental status. For this reason, potentially     unnecessary diagnostic efforts are undertaken in order to exclude a serious underlying     condition, leading to prolonged throughput times and ED observation unit stays.      On the other hand, the patients` condition might be underestimated by ED physicians, which     may result in ineffective, delayed or inadequate disposition, as well as poor patient     outcomes. BANC (formerly BAUCAS) is a series of clinical studies with the intention to     investigate the usefulness of clinical findings and biomarker levels combined for disposition     of patients with non-specific complaints presenting to the emergency department.   "
233976|NCT00920504|"     The purpose of this pilot study is to refine and test an advanced and adapted German version     of the PRO-SELF© Plus Pain Control Program (PCP), an educational intervention directed at     cancer pain patients and their families to enhance their pain self management abilities, and     to calculate effect sizes for the planning of a sufficiently powered randomized controlled     trial (RCT).   "
233977|NCT00920517|"     Dengue fever, caused by dengue viruses, is a major health problem in the tropical and     subtropical regions of the world. The purpose of this study is to test the safety of and     immune response to a new dengue virus vaccine in healthy adults.   "
233978|NCT00920530|"     Group B streptococcus infections may be serious for the neonates. The infection can occur     during the birth, by contact with the genital area. That is why the detection of this     bacteria is systematically realised in pregnant women between 34 and 37 weeks of amenorrhea     in order to give prophylactic antibiotic treatment in case or positive carriage. This     strategy presents 2 disadvantages : (1) detection of the group B streptococcus at 34 and 37     weeks of amenorrhea in not predictive of a carriage at delivery, (2) many pregnant women     escape from systematic screening, leading to a systematic antibiotic treatment, which means     useless costs, and useless antibiotic exposure with resistant bacteria selection. Real time     polymerase chain reaction (PCR) allows a rapid detection anytime with no specific     microbiological qualification. The aim of the study is to assess the economic outcomes of     this strategy and the epidemiological values for St Etienne hospital.   "
233979|NCT00920543|"     The purpose of this study was to determine whether asthma control and reduced bronchial     hyperresponsiveness could be achieved and maintained at a lower dose of inhaled     corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent     subjects with persistent asthma   "
233980|NCT00920556|"     The primary purpose of this study is to determine the safety and tolerability of SRT501 (5.0     g) with or without concurrent bortezomib administration, when administered once daily in 21     day cycles, in male and female subjects with Multiple Myeloma.      The purpose is also to define objective response (ORR, CR, PR, MR, SD) and time to     progression (TTP) of SRT501 with or without concurrent bortezomib administered concurrently     in male and female subjects with Multiple Myeloma.      In addition, 15 subjects will participate in a sub-study to assess the pharmacokinetics of     SRT501.   "
233981|NCT00920569|"     This study is to test the usefulness of ultrasound dilution measurements in patients on     extracorporeal membrane oxygenation. Measurements may include; efficiency of support     (recirculation), amount of clotting in the oxygenator (oxygenator blood volume), and how well     the heart is working (cardiac output). At the present time there are no devices available to     perform these functions.   "
233987|NCT00920647|"     Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain     barrier at therapeutic levels when administered intravenously. A new formulation of     idursulfase, idursulfase-IT, that differs from that of the intravenous (IV) formulation,     Elaprase, has been developed to be suitable for delivery into the cerebrospinal fluid (CSF)     via intrathecal administration.      This Phase I/II study is designed to obtain necessary safety and exposure data, as well as     secondary and exploratory outcome measures, to be interpreted and used in the design of     subsequent clinical trials.   "
233988|NCT00920660|"     The primary purpose of this study is to assess the pharmacodynamic effect of single, oral     doses of SRT2104 (250 mg, 500 mg, 1000 mg, 2000 mg) and prednisolone as measured by levels of     ex vivo LPS-induced TNF-alpha production in whole blood of healthy adult subjects.      The secondary purposes of this study are to assess the pharmacodynamic effects of single,     oral doses of SRT2104 (250 mg, 500 mg, 1000 mg, 2000 mg) and prednisolone (30mg) as measured     by levels of IL-6, IL-8 and IL-1beta in whole blood of healthy adult subjects. In addition,     plasma pharmacokinetics, safety and tolerability of SRT2104 following the administration of     single, oral doses of SRT2104 (250 mg, 500 mg, 1000 mg, 2000 mg) in healthy adult subjects     will also be assessed. As exploratory endpoints, transcriptomic profiles, biomarker     exploration, and relationships between plasma SRT2104 levels and ex vivo LPS-induced     TNF-alpha production may also be examined.   "
233989|NCT00920673|"     In pediatric anesthesia and in pediatric intensive care, tracheal intubation is one of the     most important procedure. To achieve this procedure as fast as possible and in is best     conditions, the physician should choose the head posture which a priori will enable at first     the best glottic visualisation during laryngoscopy, and at second will facilitate the route     of the tube from the larynx to the trachea.      Tracheal intubation is a procedure used for years, and many textbooks recommendations on the     best head posture for tracheal intubation in paediatrics have been made. Briefly summarized,     depending on the age of the child, the head should (or not) be slightly extended, and a     pillow should (or not) be positioned under the occiput. These recommendations are     questionable for three majors reasons:        -  despite an apparent consensus, some recommendations are quite different.        -  none are based on anatomical nor clinical studies        -  if for all of them, the age of the child is considered as critical point, but children          are only grossly categorized in three categories (newborn, infants and old children).          And the clinician has no way, facing a child, to make his choice between dichotomic          attitudes.      Actually, the responses to these questions should need rigourous clinical studies on     laryngoscopy, hard to design and very difficult to make. P.Adnet et coll. (Anesthesiology     2001) showed that an anatomical study with resonance magnetic imaging (MRI) can bring     indirect but strong evidence and can be a first step leading to clinical studies. Many     children need MRI study for different reasons, and it is fast and easy to get during their     examination additional images of the superior airway.      In their unit, the investigators are experienced in this kind of study, as they recently     published (Pediatric Anesthesia 2008) an MRI study demonstrating that in children, head     extension improves the alignment of the visualisation axis on the laryngeal axis, but worsens     the alignment of the pharyngeal axis on the laryngeal axis. However, patients included in     their study were in major part infants, so the influence of the age could not be properly     analyzed. Morevover, this study suffered of two main limitations, the lack of standardisation     of head postures, and that a laryngeal mask the children, who were on general anesthesia     (required for the MRI examination) were made using a laryngeal mask (as it was at this time     the standard in their institution).      The investigators propose an MRI study of the influence of age on the consequences of head     extension on the anatomic axes of the superior airway in children, with a prospective     stratified on age study. Several modifications and improvement in the design of this study     would diminished the limitations of the first study.   "
233990|NCT00920686|"     NXN-188 Dihydrochloride is being developed as an immediate release oral product for the     treatment of acute migraine. This study is being conducted to evaluate NXN-188 in subjects     with a migraine history of aura.   "
233991|NCT00920699|"     To establish the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q10     in pre-manifest participants carrying the CAGn expansion for Huntington's Disease (HD).   "
233992|NCT00920712|"     The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription     Weiqi decoction on Chronic Atrophic Gastritis.   "
233993|NCT00920725|"     The purpose of this study is to determine whether insulin administered by a subcutaneous     injection is effective in the treatment of a diabetic crisis and to determine if     beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.   "
233994|NCT00920738|"     RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors     of childhood cancer may help doctors learn more about the disease.      PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer     and in their healthy sisters and brothers.   "
233995|NCT00920751|"     Hypothesis        1. Study method achieves lower requirement for medications        2. Study method increases overall cecal intubation with comparable assessment of current          experience and patient willingness to repeat future colonoscopy compared with          conventional colonoscopy        3. Study method results in reduction in medication-related (cardiorespiratory)          complications, faster turn around of patients, compared with conventional colonoscopy        4. Study method improves bowel preparation and increases polyp pickup rate      Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic VA     patients is being promoted (VHA directive). Compliance with this Directive will result in an     increased number of VA patients undergoing colonoscopy. The demand for colonoscopy far     exceeds the capacity available to perform the procedure in the VA system. The conventional     practice for colonoscopy at VA facilities across the country is to perform colonoscopy under     conscious sedation with air insufflation. Efficiency is governed by the fact that sedated     patients require time and space for recovery and these are major limiting factors in the     current setting for the use of colonoscopy for CRC screening.      Methods that maintain a high success rate and good patient assessment improve overall     compliance for surveillance colonoscopy. Our preliminary experience showed that patients are     able to complete successful colonoscopy without sedation in 52% of cases when colonoscopy was     aided by a water infusion in lieu of air insufflation method. In this group of patients, the     shortened recovery time means a quick turn around of patient and a more efficient endoscopy     service. Patients are able to communicate better with the staff and physician regarding their     problem and discharge instructions, and not subjected to the amnesic effect of sedation. Next     day follow-up of patient by telephone contact which requires commitment of staff time can be     obviated.      If this randomized study confirms the success of our preliminary findings and this technique     is adopted by more endoscopists, a larger number of VA patients may benefit from less     sedation complications and at the same time allow for more efficient colonoscopy screening     services.   "
233996|NCT00920764|"     The study objective is to investigate the effects of three low doses of atrasentan on urinary     albumin/creatinine ratio (UACR) levels in subjects with Type 2 diabetic nephropathy.      Patients with Type 2 diabetes with nephropathy must be receiving a renin-angiotensin system     inhibitor, such as an Angiotensin converting enzyme inhibitor (ACEi) or an Angiotensin II     Receptor Blocker (ARB) for participation in this study. ACEi and ARB treatment are the     standard of care for the management of proteinuria in Chronic Kidney Disease (CKD) patients.   "
233997|NCT00920777|"     The purpose of this study is to analyze income variables in Chronic Fatigue Syndrome/Myalgic     Encephalomyelitis, and to analyze the effect of short vs. long Cognitive Behaviour Therapy.   "
233998|NCT00920790|"     To evaluate the efficacy, safety and pharmacokinetic profiles of KW-0761, the anti-CC     chemokine receptor 4 (CCR4) antibody, when administered weekly for 8 weeks as an intravenous     infusion at a dose of 1.0 mg/kg in relapsed subjects with CCR4-positive adult T-cell     leukemia-lymphoma.   "
233999|NCT00910494|"     The investigators would like to test the safety and efficacy of intraoperative radiotherapy     (IORT) in rectal cancer using the Photon Radiosurgery System (PRS).   "
234003|NCT00910546|"     The purpose of this study is to quantify the variation in tumour middle position during a     course of stereotactic body radiotherapy (SBRT), and thereby be able to design radiotherapy     margins that takes into account the full motion span throughout an entire course of SBRT.   "
234004|NCT00910559|"     The purpose of the study is to collect phenotypic (observable characteristics) and genetic     information about individuals with Autism Spectrum Disorders (ASDs) and their families.   "
234005|NCT00910572|"     Rationale: Patients diagnosed with hepatocellular carcinoma (HCC) at an intermediate or     advanced stage (according to the BCLC classification system) are not amenable of curative     treatment. According to EASL and AASLD guidelines patients with an intermediate stage HCC are     treated with trans-arterial chemoembolization (TACE) while patients with an advanced stage     HCC are treated with molecular targeted drugs or other combinations according to their liver     function. The median survival expected for patients in intermediate-advanced stages ranges     from 11 to 20 months.      Purpose of the Study: The purpose of this prospective phase II study is to determine whether     or not Radioembolization with Yttrium-90 microspheres (TheraSphere®) provides an anti-tumoral     effect and a sensible benefit in terms of time-to-progression (TTP) and survival in patients     with good liver function (Child A-B7) and a confirmed diagnosis of Intermediate or Advanced     (because of the presence of neoplastic portal thrombosis) Hepatocellular Carcinoma (HCC).   "
234006|NCT00910585|"     Asthma among low-income, minority children remains a prime example of health disparities that     are resistant to change. Demonstrations of reductions in disproportionate hospitalizations in     controlled trials are limited. We performed a controlled clinical trial of an Asthma Coach to     reduce hospitalizations among low-income, African American children.   "
234007|NCT00910598|"     This is a study in patients with clinically isolated syndrome (CIS) and early relapsing     remitting multiple sclerosis (RRMS) to assess the effects of glatiramer acetate (GA)     subcutaneously on the condition of the optical nerve in comparison to no medicinal therapy     during 12 months and to assess the use of Optical Coherence tomography (OCT), a non-invasive     ophthalmological technique, in daily practice as an alternative to magnetic resonance imaging     (MRI) scanning for follow-up of these patients.   "
234008|NCT00910611|"     A vibrating cold pack placed proximal to the site of immunization will decrease the pain of     routine preschool immunizations when compared to standard care.   "
234009|NCT00910624|"     This is a single-arm, multicenter study of boceprevir (BOC) in combination with peginterferon     plus ribavirin (PEG/RBV) in adult chronic hepatitis C (CHC) genotype 1 participants who     completed their per-protocol defined treatment and did not achieve sustained viral response     (SVR) while in the PEG/RBV control arm(s) of an Schering-Plough Research Institute (SPRI)     study of BOC combination therapy. Participants who are able to enroll in this study within 2     weeks after the last dose of PEG/RBV in previous protocol are to receive BOC+ PEG/RBV for up     to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who are not able to     enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are     to receive PEG/RBV for 4 weeks followed by BOC+ PEG/RBV for up to 44 weeks, with 24 weeks     post-treatment follow-up.   "
234010|NCT00910637|"     This study is examining a birth control patch for 13 cycles (1 year).   "
234011|NCT00910650|"     The purpose of this phase 2 study is to find the best way to give this new experimental     regimen and determine if it can treat metastatic melanoma in humans. In this phase 2 study,     the experimental products are given initially to a group of 8 people. If safe and found to     have significant anti-tumor activity, it will be given to up to 14 other people, for a total     of 22 people in this study. Physicians watch subjects carefully for any harmful side effects.     Although the experimental regimen has been well tested in laboratory and animal studies, and     a similar regimen has been given to a group of patients at the National Cancer Institute in     Bethesda, MD, the side effects in people cannot be completely known ahead of time. This     protocol is offered only to people whose condition cannot be helped by other known     treatments.      The study procedures will start with the collection of white blood cells through apheresis (a     procedure in which blood is drawn from a patient and separated into its components, some of     which are retained, such as white blood cells, and the remainder returned by transfusion to     the patient).      Subjects will be asked to undergo two aphereses, one to make the gene-modified MART-1 TCR     CTLs and the dendritic cell vaccines, and a second one after the subject receives the gene     modified cells to later study them in the blood.      On the day of the first apheresis, subjects will be admitted to the hospital and will receive     chemotherapy over the next five days which decreases the risk of rejection of the transferred     cells by the subject's immune system and facilitates their expansion and attack of the     melanoma lesions. During this time, the gene-modified MART-1 TCR CTLs and the dendritic cells     will be manufactured in the laboratory from the apheresis product and will be extensively     tested to assure that they express the appropriate TCR and that they do not contain any     contaminating bacteria or virus. Then the gene-modified MART-1 TCR CTLs will be given back to     the subject through a vein in the arm. It will be followed by vaccination with the dendritic     cells under the skin. During the next fourteen days, subjects will also receive interleukin 2     (IL-2), which is a standard treatment for patients with metastatic melanoma. During the next     2 to 3 weeks, subjects will stay in the hospital until the study investigators determine that     the subject has fully recovered from all of the procedures, and it is safe for the subject to     go home. Chemotherapy frequently causes a decrease in the platelet or red blood cells, and     therefore subjects may require platelet and/or red blood cell transfusions.   "
234012|NCT00910663|"     The objective of this study was to compare the oral availability of a test product of     Mycophenolate Mofetil 250 mg capsule to an equivalent oral dose of the commercially available     reference product, CellCept® 250 mg capsule administered to healthy subjects under fed     conditions.   "
234013|NCT00910676|"     Patients will receive local prophylactic treatment (Diprosone cream) during 8 weeks from the     beginning of the EGF-R inhibitors treatment, on the areas of the body susceptible to be     affected by folliculitis.   "
234014|NCT00910689|"     The purpose of this study is to determine if the addition of preventive medication, behavior     migraine management or the combination of preventive medication and behavior migraine     management improves the outcome of optimal acute therapy for frequent migraines.   "
234015|NCT00910702|"     The purpose of this study is to determine the feasibility, primary safety and efficacy of     foldable capsular vitreous body (FCVB) in the treatment of retinal detachment.   "
234016|NCT00910715|"     The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline     treatment in patients with erythema migrans.   "
234017|NCT00910728|"     This study is being conducted to test study drug AZD1480 to see how it may work to treat     myeloproliferative diseases. The main purpose of this study is to determine the safety and     tolerability of AZD1480. This is the first time the drug has been given to humans and is     classed as a first time in man study. Its main purpose is to establish a safe dosage of the     drug and provide additional information on any potential side effects this drug may cause.     The study will also assess the blood levels and action of AZD1480 in the body over a period     of time and will indicate whether the drug has a therapeutic effect on myeloproliferative     diseases.   "
234019|NCT00910754|"     The purpose of this study is to determine the effect of abiraterone acetate plus prednisone     on the conduction of electric charges within the heart and to determine the blood levels of     abiraterone acetate following administration in patients with metastatic castration-resistant     prostate cancer.   "
234020|NCT00910767|"     The main objective of this study is to evaluate the feasibility of closed loop insulin pump     therapy to improve overnight glucose control in adults with type 1 diabetes.   "
234021|NCT00910780|"     This project aims to identify whether therapeutic substitution of aripiprazole for     risperidone or olanzapine, combined with standard nutrition intervention, will impact the     metabolic changes associated with antipsychotic treatment in children and adolescents.   "
234022|NCT00910793|"     The objective of this study is to evaluate the effect of the combination of formoterol and     beclometasone dipropionate on central and peripheral airway dimensions in asthmatic patients     using Computational Fluid Dynamics (CFD). Further more, the effect of this combination     therapy on exhaled NO, lung function (spirometry, body plethysmography, diffusion and     resistance) and subjective asthma control score as well as the safety of this combination     will be assessed.   "
234023|NCT00910806|"     The purpose of this Phase I, open-label, single sequence drug-drug interaction trial in human     immunodeficiency virus-type 1 infected patients is to investigate the potential interaction     between steady-state nevirapine (NVP) 200 mg b.i.d. (twice a day) and a single dose of 400 mg     TMC207 and to explore the pharmacokinetics (how the drug is absorbed into the bloodstream,     distributed in the body and eliminated from the body).   "
234024|NCT00910819|"     To describe treatment reality of patients with colorectal cancer treated by office-based and     clinic-based medical oncologists in Germany.   "
234025|NCT00910832|"     The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment     of patients with dyschesia treated by rectal rehabilitation.   "
234026|NCT00910845|"     The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A     (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary     incontinence.   "
234027|NCT00910858|"     The purpose of this study is to assess pharmacokinetic and pharmacodynamic characteristics of     oral lenalidomide monotherapy administered to patients with Low- or Intermediate-1-risk     Myelodysplastic Syndrome (MDS).   "
234028|NCT00910871|"     The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207     in combination with an individualized background regimen (BR) of antibacterial drugs as     treatment for MDR-TB   "
234029|NCT00910884|"     RATIONALE: Natural supplements and a special diet may help rid the body of estrogen and     testosterone and may slow the growth of tumor cells.      PURPOSE: The purpose of this randomized Phase I trial is to first IDENTIFY, through     laboratory analysis and validating cellular biochemical pathways, and HELP CONTROL, using     natural supplements and a special diet work, extemporaneous and environmental (man-made)     hormones, hormone impacting compounds and hormone-mimicking compounds that are made outside     the body, found in manufactured products or in-taken to the body of cancer patients through     life-style, environmental or consumption products. Patients with early-stage or remission     stage prostate cancer, breast cancer, or uterine cancer have a much greater sensitivity to     these extemporaneous hormonal or hormonal influencing compounds.   "
234030|NCT00910897|"     Primary objective:        -  Compare the complete remission (CR) rates (i.e., the true CR, with negative          immunofixation) achieved with either four courses of VD or four courses of VTD.      Secondary objectives:        -  Compare the following parameters following 4 cycles of VD or VTD induction treatment:             -  CR rate+ very good partial remission (VGPR) rate             -  Overall remission rate (CR + VGPR + partial remission (PR) rate)             -  K/l light chain ratio in patients in CR.             -  Safety (quality of the sampled stem cells, extrahaematological and haematological               toxicity: specially neurological toxicity, length of hospitalization).        -  Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell          transplantation (ASCT).   "
234031|NCT00910910|"     The purpose of this study is to determine the safety and efficacy of lenalidomide as a first     line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will     compare the effects (good and bad) of lenalidomide with chlorambucil.   "
234032|NCT00910923|"     This will be a single center study conducted in two parts. Part 1 will assess the safety,     tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of     JNJ-38431055 in healthy male volunteers. Part 2 will assess the effect of food on the     pharmacokinetics of JNJ-38431055.   "
234033|NCT00910936|"     The investigators will evaluate the effects of an endurance exercise program on the physical     performance, the well being, and indicators of metabolic function in patients with an HIV     infection.   "
234034|NCT00910949|"     The study will investigate characteristics of chronic pain after thoracotomy   "
234035|NCT00910962|"     This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to     evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI. Up to approximately     525 subjects will be randomized to meet the MRI recruitment target (90 subjects in substudy.)     All subjects will continue to receive the local standard of care for the duration of the     study.   "
234036|NCT00910975|"     The purpose of the study is to investigate if the duration of treatment of hepatitis C with     pegylated interferon and ribavirin can be individualized on the basis of how fast the     hepatitis C virus concentration in the blood decreases, and if this is more cost-efficient     than standard treatment.   "
234037|NCT00910988|"     Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in     comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men,     measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production     (glucose rate of appearance [Ra]), primarily muscle glucose utilization (glucose rate of     disappearance [Rd]), and adipose tissue related free fatty acid production (glycerol rate of     appearance [Ra]).      We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in     insulin sensitivity.      Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling     pathways in antipsychotic naïve healthy young men.      We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in     insulin signaling.   "
234038|NCT00911001|"     Patients that are on total knee/hip replacement initiate prophylaxis treatment on the     hospital ground. Once they leave the hospital, as outpatients they continue with the     treatment at least during two consecutive weeks. Patients will be instructed to follow     treatment recommendations (either LMWH or oral treatment, at physician discretion) and to     come back to the surgeon after that period. At that visit, the Treatment Satisfaction     Questionaire with Medication (TSQM) test as well as the Moriski-Green Questionaire (measures     compliance with medication) will be answer by the patient. TSQM is an self administered     validated scale (validated also in spanish) that measures in a generic way the treatment     satisfaction to a treatment. Morinski-Green test will be used to measure the compliance     degree on medication.   "
234039|NCT00911014|"     Evaluate access to healthcare, comprehension of pre-operative counseling and post-operative     goals of women treated for vesicovaginal fistula in Niger through use of a questionnaire.   "
234040|NCT00911027|"     This is a phase III European multicenter, open label, prospective study to assess the     diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in     comparison with the current practice of ultrasound guided systematic biopsy. The trial will     involve 15-20 European Centers.   "
234041|NCT00911053|"     This research project consists of a three part study with five embedded sub studies. The     first study phase identifies body rhythms of sleepiness/wakefulness and of melatonin levels     for each subject (including sub-study 1). The second study phase identifies the optimum dose     and timing of melatonin for regulating each individual's 24-hour sleep/waking cycle     (including sub-study 2). The third study phase introduces a new independent variable, light     (including sub-studies 3 and 4). Sub-study 5 is an optional longitudinal study.      Sub-study 1 looks at how keeping a regular sleep schedule affects the body's natural rhythm.     Sub-study 2 looks at how individuals metabolize melatonin. Sub-study 3 tests how individuals'     endogenous melatonin production responds to bright outdoor light and Sub-study 4 tests a     previous finding that artificial bright light exposed daily behind the knee can regulate the     body clock. Sub-study 5 is an optional longitudinal study, an extension of the first study     stage, for subjects whose rhythms are not clearly free-running.   "
234042|NCT00911066|"     An open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult patients with     acute myelogenous leukemia (AML), high-grade myelodysplastic syndrome (MDS). The patient     population will consist of adults previously diagnosed with AML including high-grade MDS for     which standard curative, life-prolonging treatment does not exist or is no longer effective.   "
234043|NCT00911079|"     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above     normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the     tumor cells without affecting the surrounding tissue. Implant radiation therapy uses     radioactive material placed directly into or near a tumor to kill tumor cells. Giving     ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.      PURPOSE: This clinical trial is studying ultrasound hyperthermia therapy to see how well it     works after implant radiation therapy in treating patients with Stage III/IV cancer of the     cervix or prostate cancer with a rising prostate specific antigen (PSA) after prior local     therapy.   "
234044|NCT00911092|"     The scope of the trial is to predict the early complete clinical response to exclusive     concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per-     therapeutic proteomic profile.   "
234045|NCT00911105|"     Purpose of this non-interventional study is the documentation of efficacy and safety data of     multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily     routine practice.   "
234046|NCT00911118|"     The purpose of this study is to test the safety of a new type of IG-IMRT called     ultra-hypofractionated IG-IMRT where a higher dose of radiation is given to the tumor     during each treatment day. Since higher doses of radiation are used each day, the total     number of treatment days needed to complete this type of radiation is only five instead of     the 45-48 treatments currently used. Treatment takes place every other day and is complete     after 2 weeks. If the patient decides to get this treatment, they will come in for 5     treatments. This is different from the 48 treatments they would get normally.   "
234047|NCT00911131|"     Increasing intra-abdominal pressure (IAP) with an abdominal binder will increase pressure     within smaller esophageal varices which will therefore enhance the ability of capsule     endoscopy to detect these varices better.      Therefore, the aims of the investigators' study are as follows:        1. To determine if using an abdominal binder to increase IAP can increase the detection          rate of small esophageal varices when using capsule endoscopy.        2. To determine if using an abdominal binder to increase IAP during capsule endoscopy has a          comparable detection rate of small esophageal varices to conventional endoscopy.   "
234116|NCT00912041|"     The purpose of this study is to obtain preliminary device safety information and demonstrate     proof of principle (feasibility of efficacy) of the ability of people with tetraplegia to     control a computer cursor and other assistive devices with their thoughts.   "
234048|NCT00911144|"     The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a     booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix     at 12-18 months of age, in children primed with the same vaccines in primary study     NCT00680914.   "
234049|NCT00911157|"     The primary objective of this study is to evaluate the efficacy (as measured by the rate of     recurrent symptomatic Venous Thromboembolism [VTE] (i.e., Pulmonary thromboembolism [PE] and     Deep Vein Thrombosis [DVT])) and safety of GSK576428 as the initial treatment in subjects     with acute symptomatic DVT in an open-label design.   "
234050|NCT00911170|"     This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating     the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients     with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line     treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or     5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI).      This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either     FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall     response rate in each arm at regular intervals over a maximum of 60 months follow-up.   "
234562|NCT00917891|"     The purpose of this study is to determine whether dapivirine gel 4759 is safe for daily use     by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.   "
234051|NCT00911183|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as cyclophosphamide, vincristine sulfate, prednisone, and liposome-encapsulated doxorubicin     citrate, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. It is not yet known whether rituximab and     combination chemotherapy are more effective when given together with or without     liposome-encapsulated doxorubicin citrate in treating older patients with diffuse large     B-cell non-Hodgkin lymphoma.      PURPOSE: This randomized phase II trial is studying the side effects of giving rituximab     together with cyclophosphamide, vincristine sulfate, and prednisone with or without     liposome-encapsulated doxorubicin citrate and to see how well it works in treating older     patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin lymphoma.   "
234052|NCT00911196|"     Hepatocellular carcinoma is an aggressive disease with limited therapeutic options.     Therefore, new approaches to treat this type of cancer are needed with immunotherapy     potentially being one of these. As a first step in the development of novel therapies,     expression analysis of specific markers, including tumor antigens will be carried out, and     the correlation of expression with disease variables and clinical outcome will be assessed.     This will be done retrospectively using archived hepatocellular carcinoma tissue samples.   "
234053|NCT00911209|"     The focus of this study is to observe the impact of weight loss in overweight individuals who     have pre-hypertension (have a blood pressure reading of 121-139/81-89 mm Hg). The specific     focus is to observe the difference in diastolic dysfunction (heart function) in these     individuals at the beginning of the study and then again after 24-28 weeks. Diastolic     dysfunction in this population indicates an increased risk of heart failure in the future.     The aim of this study is to prevent or reduce the risk of heart failure in overweight     individuals with pre-hypertension.   "
234054|NCT00911222|"     The purpose of this registry is to record information on reality of anti-emetic therapies of     cancer-patients in Germany. The outcome of this study is the efficacy of anti-emetic     therapies dependent on the rate complete and major control of nausea and emesis in     moderately and highly emetogenic chemotherapies, consisting of platin-derivates (cisplatin,     carboplatin and oxaliplatin), anthracyclines and/or cyclophosphamid.   "
234055|NCT00911235|"     This study is designed to estimate the effect of fluconazole (200 mg BID for 2 days), a     moderate CYP3A4 inhibitor on the pharmacokinetics of a single 8 mg oral dose of fesoterodine     in healthy adult subjects.   "
234056|NCT00911248|"     Formation of new blood vessels (angiogenesis) is important for tumor growth in     neurofibromatosis type 2 (NF2). It is known that tumors make a protein called vascular     endothelial growth factor (VEGF) and there are higher levels of VEGF in the tumors and blood     of many patients with NF2. VEGF stimulates the formation of blood vessels that supply the     tumor with nutrients and oxygen. PTC299 is an oral drug that has been shown to decrease     production of VEGF in animal models of human cancer. In these animal models, oral PTC299     administration decreases VEGF levels in the tumor and in the bloodstream, decreases blood     vessel numbers in the tumor, and significantly slows or halts tumor growth. Safety studies in     research animals indicate good tolerability at doses and drug levels that are higher than     those planned for the clinical studies. Results from Phase 1a studies in healthy volunteers     indicate that PTC299 achieves levels of PTC299 in the bloodstream that are known to be active     in animal models of human tumor. This Phase 2 study is designed to test the hypothesis that     PTC299 will be tolerable and will show evidence of VEGF reduction, antitumor activity, and     hearing improvement when administered orally to patients with NF2.   "
234057|NCT00911261|"     The purpose of this study is to determine if Oxymorphone Extended Release is effective and     safe in treating chronic pain in patients with cancer or neuropathic pain.   "
234058|NCT00911274|"     The objective of this study was to compare the oral bioavailability of an investigational     formulation of mycophenolate mofetil (MMF) 250 mg capsules to an equivalent dose of the     commercially available reference product, CellCept® (mycophenolate mofetil) 250 mg     administered to healthy subjects following an overnight fast of at least 10 hours.   "
234059|NCT00911287|"     The purpose of this study is to determine if oxymorphone ER is effective and safe in treating     chronic pain in opioid-naive patients.   "
234060|NCT00911300|"     The purpose of this study is to test whether Fondaparinux is effective and safe to prevent     thromboembolic events (like for example strokes) and bleeding events in patients who undergo     a normalisation of their heart rhythm disturbance. Fondaparinux will be compared with Heparin     and tablets containing Vitamin-K-Antagonists (Phenprocoumon, Fluindione, or Warfarin).   "
234061|NCT00911313|"     The purpose of this study is to compare and determine the efficacy of letrozole     administration to that of combined metformin and Clomiphene in infertile women with     polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.   "
234117|NCT00912054|"     To demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Health in patients     with open angle glaucoma or ocular hypertension.   "
234062|NCT00911326|"     The purpose of this study is to determine the false negative rate (FNR) associated with     Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of     non-sentinel lymph nodes in elective neck dissection (END) in head & neck squamous cell     carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement     NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or     melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent     to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic     pathway draining the primary site of a tumor.   "
234063|NCT00911339|"     The purpose of this study is to evaluate the extent of the mobilization of endothelial     progenitor cells induced by low versus high dose atorvastatin after 4 weeks of treatment, in     patients treated with anti-CD 34 antibodies coated stent.   "
234118|NCT00912067|"     The purpose of this study is to evaluate the presence and manifestations of ocular graft     versus host disease in adults that had hematopoietic stem cell transplantation in the past 3     years at the sheba medical center, Israel. As well as correlate the degree of the     presentation to the therapeutic protocol (chemotherapy and irradiation).   "
234064|NCT00911352|"     Between 30% and 88% of chemotherapy patients receiving docetaxel experience side effects of     the hand ranging from skin and nail disfigurement, blistering, desquamation, pain, infection,     and impaired treatment-related quality of life and function. Preliminary data indicate that     nurse-initiated cryotherapy during treatment may lower the incidence and severity of these     side effects, but several issues should be addressed before this intervention is implemented     in hospital settings. These include more rigorous study design, larger sampling frames, and     consideration of infection control concerns. This study will address these issues, thereby     rigorously evaluating the safety and efficacy of nurse-initiated cryotherapy at Princess     Alexandra Hospital.   "
234065|NCT00911365|"     This study is based on positive results in open label trial of mesenchymal stem cells therapy     in patients with Multiple System Atrophy (MSA).   "
234066|NCT00911378|"     This study is a comparison of two most commonly used modes of weaning and the outcomes in the     two groups.   "
234067|NCT00911391|"     Perioperative fluid management has been historically dictated by outdated, contradictory     concepts. Excessive or inadequate fluid administration around surgery is deleterious and     hence goal-directed fluid therapy using Oesophageal Doppler-derived cardiac indices is     preferable to optimize tissue perfusion. Previous studies in this area have been hampered by     lack of standardization in other aspects of perioperative care and none have explored the     impact of individualized fluid therapy on post-operative fatigue.The investigators proposed a     study involving 80 patients having open/ laparoscopic colonic surgery to investigate the     effect of Oesophageal Doppler guided fluid administration intraoperatively compared to     current best practice of fluid restriction. The investigators have an optimized     peri-operative care pathway established at the Manukau Surgical Centre (MSC), Middlemore     Hospital. All patients will be cared for under the Enhanced Recovery After Surgery (ERAS)     multimodal care plan therefore ensuring that all other aspects of care besides intraoperative     fluid administration remain homogenous. Outcomes will include post-operative recovery,     clinical outcomes as well as physiological data with follow-up to 30 days.   "
234068|NCT00911404|"     There is evidence that controlling total amount of carbohydrates is a strategy for     controlling glucose levels in diabetes mellitus. There is not major evidence that any given     macronutrient percentage may be recommended to treat a woman with Gestational Diabetes     Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once     medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy.     Insulin treatment is more expensive and not as well accepted as MNT. The investigators have     designed a randomized-controlled trial to assess whether a diet with 40% total calories from     carbohydrates may reduce the need of insulin treatment in women with gestational diabetes,     without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total     calories from carbohydrates.   "
234069|NCT00911417|"     The Jetstream System is a commercially available rotating, aspirating, expandable catheter     designed to remove atherosclerotic plaque and blood clots in the lower limbs. The purpose of     this study is to use intravascular ultrasound (IVUS) during the interventional procedure to     measure the amount of plaque and blood clots removed by the Jetstream System.   "
234070|NCT00911430|"     The incidence of community-associated (CA) staphylococcal infections, especially those caused     by methicillin-resistant Staphylococcus aureus (MRSA), has increased dramatically in recent     years. Although the majority of these infections are limited to the skin and soft tissue and     thus not life threatening, the number of invasive cases in otherwise healthy individuals is     increasing and some are fatal. As a first step toward understanding pathogenesis, there has     been significant focus on elucidating the key CA-MRSA virulence factors. The relative     significance of these factors is still being delineated. By comparison, there has been little     focus on host factors associated with these invasive infections. In this protocol, we will     recruit 100 otherwise healthy subjects with invasive staphylococcal infection, 50 otherwise     healthy subjects with recurrent staphylococcal infections, and obtain samples from 150     unidentified healthy controls from the blood bank to investigate host immunologic factors     predisposing people to staphylococcal infection. Subjects will receive standard of care     treatment for acute or recurrent staphylococcal infections. The primary objective of this     research is to identify host genetic factors that contribute to susceptibility or severity of     community acquired staphylococcal diseases. We will use three experimental approaches to     complete this objective: 1) expression microarray analyses of study population s (subjects     and controls) white cells (neutrophils and peripheral blood mononuclear cells) at rest and     stimulated with staphylococci, 2) evaluation of toll-like receptor (TLR) pathways in the     study population s cells, and 3) evaluation of Th17 cells. The proposed research will address     a key area of staphylococcal pathogenesis for which there is a striking lack of information.     We fully anticipate that the research also will provide critical new information directly     relevant to vaccine, diagnostics, and therapeutics development.   "
234071|NCT00911443|"     The purpose of the study is to test safety and efficacy of different doses of thymosin alpha     1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without Interferon     alpha in treating patients affected by stage IV melanoma.      Primary end-point is Tumor Response evaluated according to Response Evaluation Criteria In     Solid Tumors (RECIST). Secondary end-points are Overall Survival and Progression Free     Survival.      Ninety-five patients are allocated to each arm to test the hypothesis that P0 <= 0.05 vs the     alternative hypothesis that P1 >= 0.15 (alpha = 5%, within-group statistical analysis beta =     95%).   "
234072|NCT00911456|"     To determine if the Clarity 3DUS (3D Ultrasound) system can be used by multiple individuals     to acquire 3DUS images and produce consistent TB (Tumor Bed) shifts for breast IGRT     (Image-Guided Radiation Therapy).   "
234110|NCT00911963|"     The purpose of this study is to assess antiviral activity when administered alone for 3 days     or in combination with peginterferon and ribavirin for 12 weeks. This study will also     evaluate the safety and tolerability of treatment with VCH-222 when given alone or in     combination with peginterferon and ribavirin.      The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.   "
234073|NCT00911469|"     Osteoarthritis (OA) is one of the most common diseases affecting the joints, usually those     that are weight bearing such as the knees. OA is considered to be a disease of the cartilage     in the joints even though it involves the whole joint, including the bone and synovium (thin     lining of the joints which produces synovial fluid). With time, more and more of the     cartilage is destroyed by the disease with inflammation commonly occurring.      AS902330 is expected to increase the production and development of specific bone cells:     chondrocytes and osteoblasts (cells that produce and maintain bone and cartilage). This is     expected to lead to repair and regeneration of the cartilage, and a narrowing of the space     width between the knee joints in a selected region of the knee.The purpose of this study is     to see how safe treatment with AS902330 is, and to evaluate its effect on the knee cartilage.     In addition, the study will also measure the effects of AS902330 in the blood.   "
234074|NCT00911482|"     The overall hypothesis of these studies is that circulating triglycerides, coming primarily     from fat in the diet, are an important source of free fatty acids. Free fatty acids are the     major fat fuel in the body, and when they are elevated in the blood they are thought to raise     the risk of cardiovascular disease by causing insulin resistance (in some cases leading to     diabetes), raising blood pressure, and other effects. The investigator will use sophisticated     methods for tracing triglycerides and free fatty acids in the blood. These methods involve     the administration of low doses of radioactive and stable isotopes of naturally occurring     fats. The studies will determine the contribution of triglycerides to free fatty acids in     normal people and also in people with diabetes.   "
234075|NCT00911495|"     This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with     stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular     effects of intravenous GMI-1070 in the outpatient setting.   "
234076|NCT00911508|"     The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial)     CABANA Trial has the overall goal of establishing the appropriate roles for medical and     ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the     hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of     eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy     with either rate control or rhythm control drugs for decreasing the incidence of the     composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest     in patients with untreated or incompletely treated AF.   "
234077|NCT00911521|"     The purpose of this trial is to study the effect of Human Papillomavirus (HPV) vaccination on     the elevation of antibody titer to 4 serotypes of HPV in patients with systemic lupus     erythematous and compare the antibody response with an equal number of age-matched healthy     women.   "
234078|NCT00911534|"     The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole     extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux     disease (sGERD).   "
234079|NCT00911547|"     This study will investigate the additive effect of montelukast (MK0476) taken along with     inhaled beclomethasone versus inhaled beclomethasone alone.   "
234080|NCT00911560|"     The purpose of this study is to test the safety and what effects, good and/or bad, treatment     with a vaccine against neuroblastoma has on the patient and the cancer. In the first part of     this study we found the highest dose of the vaccine that did not have too many side effects.     We are now trying to find out what effects the vaccine has when given at the same dose to all     patients.      The main treatment in this protocol is a vaccine. It is called a  bivalent vaccine which     means it has 2 antigens. An antigen is a specific protein on the surface of a cell. The     antigens are called GD2L and GD3L.      We want the vaccine to cause the patient's immune system to make antibodies against the     antigens. Antibodies are made by the body to attack cancer (and to fight infections). If the     patient can make antibodies against the 2 antigens in the vaccine, those antibodies might     also attach to neuroblastoma cells because a lot of each antigen is on neuroblastoma (and     very little on other parts of the body). Then, the attached antibodies would attract the     patient's white blood cells to kill the neuroblastoma. This protocol also uses β-glucan which     is a kind of sugar from yeast. β-glucan is taken by mouth and can help white blood cells kill     cancer. The best way to get the body to make antibodies against the 3 antigens is to link     each antigen to a protein called KLH (which stands for: keyhole limpet hemocyanin) and to mix     them with a substance called QS-21. But it is hard to get enough QS-21 so we are using an     identical substance called OPT-821, which we can get easily in large amounts for use in     patients.   "
234081|NCT00911573|"     The main purpose of this study is to compare the safety and efficacy of tigecycline versus     clindamycin (including subjects treated with vancomycin) in pediatric subjects (aged 8 to 17     years) with complicated skin and skin structure infections (cSSSI), including those caused by     methicillin-resistant staphylococcus aureus (MRSA).   "
234082|NCT00911586|"     The purpose of the study is to confirm how long (i.e., how many days) it takes to reach     steady-state when testosterone undecanoate is administered twice daily.   "
234083|NCT00911599|"     The primary aim of this study is to demonstrate that blood ion levels (cobalt and chromium)     are lower at one year in patients who receive a metal on polyethylene total hip as compared     to CONSERVE® A-Class Total Hip with BFH® technology. Secondary aims include the gathering of     clinical data regarding survival and dislocation rates at two years post surgery, as well as     the assessment of pain, physical function, radiographic and clinical outcome at the two year     interval.   "
234084|NCT00911612|"     Our hypothesis is that the medication approved for treatment of high blood cholesterol     levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients     with diarrhea due to irritable bowel syndrome.      This effect is thought to result from the effect of the medication on bile acids, which can     cause diarrhea.   "
234085|NCT00911625|"     It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in     renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily     plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction     algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR     by MDRD as follows: < 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based     calculation.   "
234119|NCT00912080|"     Method: This multicentric prospective cohort is composed of patients with no metastatic     breast cancer selected by tumor's genomic analysis and treated by chemotherapy with     Anthracycline without Taxanes (6 cycles of FEC 100).      The patient can be included before or after the surgery and a written consent must be signed     for the proteomic and genomic analysis of the tumor.      Patients who have a good signature for the genomic analysis will receive the standard     chemotherapy.      Primary objective:        -  To compare metastasis free survival at 5 years in a cohort of patients with no          metastatic breast cancer, who are selected by their genomic profile of the tumor and          received a standard chemotherapy containing Anthracycline, with result of retrospectives          studies.      Secondary Objectives:        -  Overall survival.        -  Creation of a circuit (transport-extraction-genomic analysis-result) which allows the          beginning of the chemotherapy within 6 weeks following the primary surgery.        -  Histological and seric proteomic exploratory studies.   "
234086|NCT00911638|"     Ministries of Health consider wait lists for total joint replacement a top priority. Research     priorities to manage wait lists indicate the need to establish benchmarks that consider     patient preferences. However, patients' preferences for hip or knee replacements are strongly     associated with their misperceptions of the indicators for, and the risks and benefits of,     these procedures. These misperceptions can be corrected with the use of patient decision     aids. When decision aids are used in combination with assessing surgical eligibility, there     may be a reduction in unnecessary referrals for surgery either because the patient is     ineligible or because the eligible candidates make informed decisions to forgo this option.     The primary study objective is to evaluate the effect of patient decision aids (PtDAs) on     total wait times (wait times for surgical consultation, plus wait times for surgery) when     used in combination with a general practitioner run clinic to screen patients with hip or     knee osteoarthritis for surgical eligibility. Major secondary objectives include determining     (a) the effect of PtDAs on surgery rates within two years, (b) the effect of PtDAs on     decision quality, and (c) cost-effectiveness of PtDAs for total joint arthroplasty.   "
234087|NCT00911651|"     The objectives of this study are to assess the effect of salbutamol in comparison with     ipratropium bromide on the geometry of central and peripheral airways and to correlate     spirometric indices with the Computational Fluid Dynamics (CFD) based calculated airway     volumes and resistances for both compounds.   "
234088|NCT00911664|"     To find out if vitamin D supplementing can lead to an improvement in immunological status in     HIV-infected children as part of routine clinical care   "
234089|NCT00911677|"     Patients with the APOE-ε4 genotype are at increased risk of both vascular dementia and     peripheral vascular disease. Patients undergoing major vascular surgery are at particularly     high risk of delirium and other, more subtle, changes in cognitive function following     surgery. The hypothesis of this trial is that the APOE-ε4 genotype is associated with both     delirium and postoperative cognitive dysfunction (POCD).   "
234090|NCT00911690|"     This study is collecting tissue specimens (blood, urine and saliva) from up to 1000 patients,     with and without cognitive disorders, to store in the Bio Bank for future research. The     specimens could be used in future research projects that could help improve the accuracy of     diagnosis of a disease, predict who might develop a disease, help monitor the disease, or     improve the understanding of the disease. Patients are only being recruited from Beaumont     Hospitals Geriatric Clinic.   "
234091|NCT00911703|"     The purpose of this study is to determine if certain findings (blood tests, symptom     improvement, etc.) after acute heart failure treatment can identify a group of patients who     are safe for early hospital discharge.   "
234092|NCT00911716|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     docetaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) together with bevacizumab may kill more tumor cells.      PURPOSE: This clinical trial is studying the side effects of giving bevacizumab together with     docetaxel and cyclophosphamide and to see how well it works in treating patients with     early-stage high-risk breast cancer.      This is a single arm, non randomised pilot study investigating the safety of the combination     of Docetaxel + Cyclophosphamide+ Bevacizumab in the adjuvant treatment of patients with early     stage, HER 2 negative, high risk breast cancer.   "
234093|NCT00911729|"     The purpose of this qualitative study is to evaluate the clarity and comprehensiveness of two     disease-specific questionnaires, and to evaluate how effective these questionnaires are at     assessing the quality of life and symptoms of patients with pheochromocytoma or     paraganglioma.   "
234094|NCT00911742|"     The main purpose of this study is to compare the pharmacokinetic profile to establish the     better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg,     Labopharm) and its bioavailability in relation with the commercialised reference (Zytram®     tablets of 200 mg, Zambon), single dose administered.   "
234095|NCT00911755|"     Endotracheal Intubation (ETI) is done to place a plastic tube in a patient's trachea     (windpipe) to assist with breathing. Patients admitted to the intensive care unit (ICU) are     the sickest of patients and the majority of them require this life saving procedure. A     critical illness can be sudden and ETI required urgently. The doctors performing ETI in these     situations may not be experts at ETI. Studies have shown that if it takes more than one     attempt to get the tube in the right position patients can have severe complications such as:     decrease level of oxygen in the body, decrease blood pressure, and cardiac arrest. These     complications can be life threatening and increase the length of time spent in an ICU.      To perform ETI the doctor uses a metal tool called a laryngoscope that is placed through the     patient's mouth to open the throat and then pass the tube into the trachea. The type of     procedure that has been used for many years is called Direct Laryngoscopy (DL) which means     that the doctor looks through the mouth directly into the throat. Newer technology is     available and can be used at VGH called Video Laryngoscopy (VL). With VL there is a camera on     the end of the laryngoscope and a video image is displayed on a monitor making it easier to     see the entrance to the trachea. VL is not available for all cases at VGH and is unavailable     in many other hospitals.      In this study we will compare DL to VL. Patients will be randomly placed in one of two     groups: first attempt at ETI done with DL or first attempt of ETI done with DL. Patients will     only be considered eligible for this study if the doctor feels that either DL or VL would be     appropriate for the patient. In this pilot study we hope show that conducting a larger study     would be feasible. If a larger study were to show that VL decreases complications and     shortens length of ICU stay we would be able to recommend this procedure for all ETI at VGH     as well as other hospitals where it currently may not be available.   "
234096|NCT00911768|"     The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth     (Xerostomia).   "
234111|NCT00911976|"     The specific aim of the SOS-Xience V study is to examine the 12-month incidence of binary     angiographic in-stent restenosis after implantation of the Xience V stent in aortocoronary     saphenous vein bypass graft lesions.   "
234112|NCT00911989|"     The main objective of this trial is to evaluate endoscopic visualization during a     laparoscopic sleeve gastrectomy (LSG) procedure using an endoscope inserted transvaginally     through a new device called a Steerable Flex Trocar (SFT).   "
234113|NCT00912002|"     A single dose, open label study to characterize the routes of elimination and determine the     mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male     participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples     will be collected to determine relative quantities of 14C-labeled MK-0941.   "
234114|NCT00912015|"     The purpose of this study is to evaluate the long-term safety (up to one year) of Tramadol     Once-A-Day (OAD) tablets at the highest doses: 200-400 mg   "
234097|NCT00911781|"     One of the most important and unique characteristics of infantile hemangiomas is their     dramatic growth during early infancy. Most hemangiomas are either absent at birth or barely     evident as a small scratch or bruise-like area. A recent study emphasized how early     hemangioma growth occurs. In this study by 3 months of age, hemangiomas had reached 80% of     their final size, and by 5 months of age, 80% had already stopped growing. Unfortunately the     average age when most infants are seen by specialists is often at 5 months of age or later, a     time when most growth is already completed.      Researchers at the University of California, San Francisco, the Medical College of Wisconsin,     and at the Mayo Clinic are interested in studying hemangioma growth at even earlier ages,     before 3 months of age, which is before most patients are ever seen by dermatologists or     other specialists. For this study are requesting that parents of children older than 3 months     of age with hemangiomas send us a series of photographs of their child which demonstrates     this early growth. Ideally the photographs would show your child (including the area of the     hemangioma of course) at weekly or every other week intervals up until age least 3 to 6     months of age. This will probably not be difficult if the hemangioma is on the face but we     would be interested in other body locations as well, if available.      We are using these photographs to analyze early hemangioma growth patterns, to see if there     is a period of especially rapid growth, and to help determine if there is a specific time     before which specialty referral should occur. We are interested in all sizes of hemangiomas,     from small to large. Of greatest importance is that the photos be at frequent intervals     (every 1 to 2 weeks is ideal) and of sufficient quality to be able to evaluate the appearance     of the hemangioma.   "
234098|NCT00911794|"     The purpose of this study is to determine whether Written Disclosure Therapy (WDT) is of any     benefit to patients with chronic lung diseases who are participating in pulmonary     rehabilitation.   "
234099|NCT00911807|"     The study was performed to compare the safety and efficacy of Cerebrolysin (10 mililiters     [ml]), Aricept (10 miligrams [mg]), and a combination of both treatments on cognitive     performance and global function in patients with probable Alzheimer's Disease (AD). It should     also be assessed if the treatments have a positive effect on activities of daily living and     neuropsychiatric symptoms.      Oral treatment with Aricept or Placebo was given once daily throughout the study. Intravenous     treatment with Cerebrolysin or Placebo was given once daily for 5 days per week during week 1     to 4 and during week 13 to 16 of the study. During the study patients had six visits at the     hospital for evaluation.   "
234100|NCT00911820|"     There is no clear standard of care for metastatic stomach or esophageal cancer in the United     States. The purpose of this research study is to determine the differences between two     regimens of chemotherapy; Arm A: PCA (Cisplatin, Irinotecan and Bevacizumab) and Arm B: TPCA     (Docetaxel, Cisplatin, Irinotecan and Bevacizumab). Docetaxel, Cisplatin, and Irinotecan are     traditional chemotherapy drugs. Bevacizumab is an antibody (a protein that attacks a foreign     substance in the body). Bevacizumab is believed to stop the formation of new blood vessels     that carry nutrients to tumors. Both of the chemotherapy regimens (PCA and TPCA) have been     studied in patients with esophageal and gastric cancer, and we are trying to determine if one     regimen will keep your cancer from growing and improve how long you can live.   "
234101|NCT00911833|"     Background:        -  Genetic research has implications for drug development and marketing. Race-based          medicine may be able to provide specific treatment for populations with increased          disease-specific morbidity and mortality. However, contemporary genetic research refutes          the idea that races are genetically distinct populations, even as drugs designed for use          in specific races are being promoted.        -  Studies have shown high levels of public suspicion for race-based and personalized          genetic medicine. Concerns related to not only the potential performance of race-based          drugs, but also the motives of those offering these drugs. Many participants have          suggested conspiracy theories in which race-based medicine was disguising an attempt to          provide inferior medications or deliberately harm certain populations. Concerns about          personalized medicine often have to do with privacy and other personal concerns.        -  Public suspicions of race-based medicine, and to a lesser extent, personalized genetic          medicine, make it important to examine and understand the theoretical and empirical          literature on trust and health care.      Objective:      - To describe the perspective of participants evaluating the medicine offer.      Eligibility:        -  Males and females ages 18 and older who are visiting the John Hopkins clinics (primarily          the adult care clinics).        -  Participants must be able to take a literacy screen and respond to a short survey.      Design:        -  Participants will be asked to take a researcher-administrated literacy screen, read one          of three randomly assigned vignettes, and fill out a survey. The first page of the          survey will provide information about the study.        -  Participants will respond to initial questions about demographics, experiences with          discrimination, and trust in the medical profession and institutions.        -  Each participant will receive a random vignette in which he/she will imagine him/herself          being diagnosed with a common, chronic condition and offered a conventional drug, a          race-based drug, or a genetically personalized drug.        -  After being presented with the vignette, participants will be asked to respond to a          survey that asks about their levels of trust in the vignette doctor, perceived respect          given to the patient by the vignette physician, emotional response to the vignette,          their belief in the effectiveness and safety of the drug prescribed in the vignette,          information sufficiency, and their hypothetical behavioral intention to take the drug.        -  Participants will be debriefed after completing the survey, and will be offered a small          amount of compensation for participating.   "
234102|NCT00911846|"     Main intention of this study is to find out whether there is a difference between the     attitudes towards opioid- substitution of opioid dependent patients under substitution with     methadone, buprenorphine or without substitution and their therapists   "
234103|NCT00911859|"     The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab)     when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with     VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and     bone marrow).   "
234104|NCT00911872|"     The purpose of this study is to gather information about the immediate effects and recovery     time for treatment with EVOLENCE/EVOLENCE BREEZE for soft tissue augmentation. The time it     takes for patients to feel comfortable with the results, and return to their normal daily     routine is also of important interest   "
234105|NCT00911885|"     Identifying a simple dietary recommendation for weight loss and metabolic health may     demonstrate potential for a simple public health message to impact coronary heart disease     (CHD) prevention and metabolic syndrome. In a randomized clinical trial, the investigators     propose to compare the efficacy of two intervention approaches to dietary change for CHD     prevention among persons with metabolic syndrome. The two approaches are 1) the AHA Dietary     Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. The     investigators hypothesize that a message promoting high fiber intake may be the simple     message that has potential to produce broad impact.   "
234106|NCT00911898|"     This study is an open-label Phase 1 trial of MM-111.   "
234107|NCT00911911|"     The scope of the trial is to identify proteomic signatures correlated with tumor response to     neo-adjuvant chemotherapy.   "
234108|NCT00911924|"     Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle     glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication     added at 6 months, as required.   "
234109|NCT00911937|"     This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on     micturition related nocturnal urgency episodes.   "
234115|NCT00912028|"     The purpose of the study is to evaluate the possible benefits of second generation silicone     hydrogel contact lenses.   "
234563|NCT00917904|"     The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use     by healthy women in South Africa.   "
234122|NCT00912119|"     Craniofacial reconstruction surgery involves a surgical approach to the craniofacial region     to repair cranial vault and facial deformities. The surgery is extensive, often requiring     wide scalp dissections and multiple osteotomies and has been associated with significant     morbidity. Some of the most severe and commonly seen problems are associated with the rate     and extent of blood loss.      Efforts to minimize surgical bleeding may translate to reduced transfusion requirements and a     lessening of associated risks Epsilon-aminocaproic acid (EACA), an inhibitor of fibrinolysis,     reduces transfusion requirements in children undergoing procedures on cardiopulmonary bypass     (CPB), as well as in older children undergoing spinal surgery for scoliosis (1-6).      Before controlled studies to assess efficacy of EACA in a craniofacial surgical population     can be done, appropriate pharmacokinetic (PK) data are needed to determine the optimal dosing     strategy. PK data exist for EACA in children undergoing operations on CPB and hypothermia.      The aim of this study is to determine the pharmacokinetics of EACA in infants and children     undergoing craniofacial reconstruction procedures.   "
234123|NCT00912132|"     Background:        -  Normal fetal growth is a critical component of a healthy pregnancy and the long-term          health of the offspring. Pivotal to understanding the dynamics of human fetal growth and          to defining normal and abnormal fetal growth is the development of standards for fetal          growth.      Objectives:        -  To establish a standard for normal fetal growth and size for gestational age in the U.S.          population.        -  To create an individualized standard for fetal growth potential.        -  To improve accuracy of fetal weight estimation.      Eligibility:        -  Healthy, low-risk pregnant women (both obese and nonobese) between the ages of 18 and 40          from each of the following four self-identified race/ethnicity backgrounds: African          American, Asian, Caucasian, and Hispanic.      Design:        -  Women will be recruited in the first trimester and followed up through pregnancy.        -  Each woman will receive six scheduled ultrasound exams, which will include the following          tests:        -  Fetal biometry (biological statistics) at all visits.        -  Uterine artery and fetal Doppler studies at selected gestational weeks.        -  Women will be asked to donate blood samples at enrollment and at follow-up visits at 16          22 weeks, 24 28 weeks, and 34 37 weeks of gestation.        -  After delivery, the newborn will be carefully measured to record birthweight, head          circumference, and other body measurements.        -  Cord blood, plasma, and placenta samples will be collected from selected newborns.        -  Post-study evaluations:        -  Women who are diagnosed with gestational diabetes during pregnancy will be asked to          return for a follow-up visit 6 weeks after delivery.   "
234124|NCT00912145|"     To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg.   "
234125|NCT00912158|"     Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation     (NIV) in addition to conventional medical treatment might be beneficial for patients with     CPE.   "
234126|NCT00912171|"     The aim of the project is to evaluate whether therapy with leukotriene may be a valid     therapeutic approach in children with adenotonsillar hypertrophy and with mild and moderate     obstructive sleep apnea syndrome (OSAS) and to evaluate whether leukotriene is less, equally     or more efficient than nasal steroid.   "
234127|NCT00912184|"     This trial aims to study the effect of combining continuous and a new polyamide membrane with     larger pores in the treatment of critically ill patients with acute renal failure and low     blood pressure (shock) requiring noradrenaline. The investigators wish to compare the     clinical effect of this new therapy to that of haemofiltration with a standard membrane.   "
234128|NCT00912197|"     This study seeks to look into the effects of oligofructose supplementation on appetite,     energy intake, and body weight and body composition in overweight subjects. Compared to a     placebo product (cellulose) oligofructose is hypothesised to suppress hunger and thereby     reduce food intake moderately leading to a decrease in body weight.   "
234129|NCT00912210|"     The broad aim is to determine efficacy of a weight loss diet higher in protein and lower in     carbohydrate combined with low intensity exercise to favorably impact body composition, bone     health, physical function, metabolic disease and quality of life compared to a conventional     higher carbohydrate diet in overweight women over age 60.   "
234130|NCT00912223|"     Blood stem cell transplants are one treatment option for people with lymphoma or other types     of blood cancers. For this type of treatment, family members or unrelated donors with a     similar tissue type usually donate their blood stem cells to the transplant patients. This     study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower     doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).   "
234200|NCT00920959|"     To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and     comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of     age with asthma.   "
234132|NCT00912249|"     Horticultural Therapy (HT) uses plants, gardening, and the close relationship between     well-beings and plants. It integrates effort, hope, expectation, harvest and the enjoyment of     whole process to help people with disabilities. During the process, patient can learn more     about themselves and experience the nature.      It can be traced to 1798, Dr. B. Rush found farm work helped people with mental illness.     Today, horticulture therapy is well applied in disabilities, elderly and children. It needs     detailed evaluation for the condition of illness to achieve optimal efficacy. It contains two     parts- to sense and to operate! Patients can relax themselves and learn to work with others,     realize the responsibility of caring another life, understand their relationship with     environment. Patient can tolerate frustration better via acceptance the withered plants. In     cultivation, it trains patient the occupational technique ( to operate instrument),     communication, social skill, independence, stable mood.      Based on studies, 0ne third patients with mental illness stabilized after treatment. However,     aggressive rehabilitation is necessary to maintain their function. In our study, it plans to     incorporate horticulture therapy into psychiatric clinical practice in our hospital. We plan     to recruit horticulture therapist, visiting staffs, residents, occupational therapists and     nurses to participate the design and operation in class.      This program will recruit patients with schizophrenia, bipolar disorder, organic brain     syndrome and other mental illness in our daycare. We will help patients with personal     treatment record. We will use case study to report some typical cases. All the cases will be     investigated qualitatively with intensive interview to explore the subjective experience on     this therapy. We will also use simple questionnaire to found quantitative study in the     further.      To sum up, this program helps the connection for horticulture therapy and psychiatric     rehabilitation. It promotes  patient-centered support and offers physical, mental , social,     spiritual services. It not only produces academic performance but fulfills the ideal of     holistic health care!   "
234149|NCT00912470|"     The purpose of this study is to assess the correlation of vascular parameters, including     genetic factors as well as ocular blood flow parameters against the progression rate of     glaucomatous damage in patients with progressive OAG.   "
234133|NCT00912262|"     The purpose of this single-blinded study in healthy volunteers is to select a     Low-Concentration Capsaicin Topical Liquid (LC-CTL) to serve as a control formulation in the     further clinical development of Capsaicin Topical Liquid, NGX-1998 (10% w/w). The goal is to     identify a low concentration formulation that will not reduce ENFD in healthy normal     volunteers when compared to NGX-1998 (10% w/w) but would still produce some local     capsaicin-related application site responses (e.g. erythema, heat sensation or pain) when     applied.   "
234134|NCT00912275|"     Phase I part: to determine the recommended dose, and observe the preliminary response and     safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2     positive metastatic breast cancer.      Phase II part: to determine the progression free survival, response rate, and to evaluate the     safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2     positive metastatic breast cancer.      Phase I part has been completed. Phase II part is underway.   "
234135|NCT00912288|"     No Dimebon clinical data exist yet in patients with disease that has advanced to the     moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon     in patients with moderate-to-severe AD who are receiving existing background therapy with     memantine.   "
234136|NCT00912301|"     The study hypothesis is that the naturally occurring bile acid, chenodeoxycholic acid,     induces acceleration of colonic transit in health and in patients with     constipation-predominant Irritable Bowel Syndrome (IBS-C).   "
234137|NCT00912314|"     This study has 2 parts. Part 1 is a 12-week observational study of weekly Posterior Tibial     Nerve Stimulation (PTNS) treatment for women with overactive bladder. Part 2 is a randomized,     controlled trial of monthly maintenance PTNS therapy versus no therapy in subjects who were     successfully treated by PTNS in Part 1.      Part 1: 12-week observational study of weekly PTNS treatment.      The primary aim of Part 1 is to determine the efficacy of a 12-week course of PTNS in the     treatment of overactive bladder. Secondary aims are to determine the changes in voiding     frequency and quality-of-life measures after the 12-week treatment.      Part 2: Randomized, controlled study of monthly PTNS compared to no PTNS after 12-week     treatment      The primary aim is to determine time-to-failure after 12 weeks of PTNS in subjects who     receive maintenance therapy compared to those who do not, in order to ascertain if there is a     need for maintenance therapy after 12 weeks of PTNS. The investigators' secondary aims are to     compare the long-term efficacy and quality of life impact in patient receiving maintenance     PTNS compared to those that do not and to determine the efficacy of rescue maintenance PTNS     in subjects who have symptom recurrence in the no maintenance therapy arm.      Hypothesis: There will be no difference in time to failure between women randomized to     monthly maintenance PTNS compared to no maintenance PTNS.   "
234138|NCT00912327|"     Study BT-CL-PGG-CRC0821 is a Phase 2, open-label, multicenter, efficacy and safety study. It     will be conducted using a two-stage design with the intention of determining the initial     efficacy of Imprime PGG in combination with a monoclonal antibody (MAb; cetuximab) in the     treatment of KRAS-mutant colorectal cancer (CRC). Both stages will be conducted in subjects     with Stage IV CRC demonstrating the KRAS gene mutation. Subjects will dose until progression     of disease or discontinuation from the study for other reasons; e.g., safety, non-compliance.     Approximately 56 subjects will be enrolled at three participating centers (17 into Stage 1     and 39 into Stage 2).   "
234139|NCT00912340|"     This phase II trial studies how well everolimus with or without trastuzumab works in treating     patients with breast cancer that has not responded to hormone therapy and has spread from     where it started to other places in the body. Everolimus may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving     everolimus and adding trastuzumab at the time of disease progression may be an effective     treatment for breast cancer.   "
234140|NCT00912353|"     This is a Phase I, single center, randomized, double-blind, placebo-controlled single     ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268     in healthy Japanese subjects.   "
234141|NCT00912366|"     Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.   "
234142|NCT00912379|"     The purpose of this study is to compare the hemoglobin results obtained with the Masimo SpHb™     device and the Clinical Laboratory.   "
234143|NCT00912392|"     Background:      The effect of existing treatment modalities of extensive disease small-cell lung cancer     (ED-SCLC) is unsatisfactory. Progress of new strategies including more efficient therapy is     wanted. Endostar® (Rh-endostatin Injection) may have anti-tumor activity by against vascular     endothelial growth factor for initial treatment. This study was designed to evaluate the     safety and efficacy of Endostar® combined with etoposide-carboplatin (EC) chemotherapy in     patients with ED-SCLC seeking for more effective treatment.   "
234557|NCT00917826|"     The purpose of this study is to assess whether administration of Arginine Butyrate +     ganciclovir/valganciclovir for up to three 21-day cycles is tolerable, and results in partial     or complete responses in patients with EBV(+) lymphoid malignancies.   "
234144|NCT00912405|"     This study allows continued access to the Sinexus Intranasal Splint while a marketing     application is being prepared. This study will generate additional performance, reimbursement     and safety data for the steroid-eluting Sinexus Intranasal Splint when used following     Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).   "
234145|NCT00912418|"     This study is an open-label, pilot study of an autologous tumor cell vaccine.   "
234146|NCT00912431|"     The objectives of this study are to determine the cerebrospinal fluid (CSF) levels of ABT-126     and to examine the effects of ABT-126 on exploratory biomarkers after administration of a     single does of ABT-126 in healthy volunteers.   "
234147|NCT00912444|"     The purpose of this study is to compare the pathological complete response (pCR) rate in     triple-negative or Her2 positive breast cancer patients treated with neoadjuvant docetaxel,     anthracycline and cyclophosphamide (TAC) or docetaxel and cyclophosphamide (TC) regimen.   "
234148|NCT00912457|"     The purpose of this study is to determine the effects of the anticholinesterase drug     donepezil on sleep apnea patients. Sleep structure and respiratory parameters will be     analyzed by polysomnography.   "
234150|NCT00912483|"     The Venous thromboembolism (VTE) disease is very frequent, mainly as complications of medical     diseases and surgical procedures. It has high prevalence and can lead to severe complications     such as pulmonary embolism and postthrombotic syndrome. Although its incidence has been     decreasing in recent years, the EP and DVT is still a major public health problem, especially     in advanced age.      The tracking of this disease through imaging tests in asymptomatic patients does not seem to     be a cost-effective, further treatment of complications is expensive and subject to no     satisfactory answers are not completely effective in regard to late complications. Therefore,     according CAIAFA & BASTOS (2002), effective prophylaxis is the best strategy.      The type of prevention to be used should be based on the risk of developing VTE, ie low,     medium or high. Framework for a category of risk for the indication of prophylaxis, each     patient should be evaluated individually and carefully to the risk of developing VTE. Maffei     et al. (2005) describe the Standards for Clinical Guideline for the prevention, diagnosis     and treatment of deep vein thrombosis. According to the guide, the concentration of heparin     in 5.000UI is indicated for cases of moderate-risk surgeries. Are classified as moderate     risk to more surgery (general, gynecological and urological) in patients 40 to 60 years     without additional risk factors, and the magnitude of any surgery in patients under 40 years     of age who use estrogen ( Annex 01). The dosing schedule chosen in this study also follows     the recommendation of the guide and is universally used .      According to Maffei et al. (2005), the diagnosis of VTE must be initiated by the history and     physical examination, and then must be performed ultrasound Doppler of lower limbs. Thus, the     ultra-sonography/doppler examination will be done at the beginning and end of treatment and     physical examination will be done periodically throughout the period of monitoring.      Following the guidelines proposed by the literature consulted, was established to test this     methodology, which aims to demonstrate the non inferiority clinical heparin sodium 5.000UI /     0.25 mL sodium heparin on 5.000UI / 1.0 mL, both produced by Blausiegel Industry and Trade     Ltda. in reducing the incidence of VTE. The two formulations are produced from the same     material, but have different drug concentrations. Thus, there is a need to scientifically     prove that the therapeutic activity and safety of the product test is non-inferior to the     comparator drug (APP heparina - 5.000 USP/mL), allowing the sponsoring company to obtain the     registration of the product in the concentration of 5000UI /0.25 mL in ANVISA at the proposed     therapeutic indication in the study.   "
234151|NCT00912496|"     This research will study safety and the body's immune (defense system) responses, including     anti-H5 flu antibodies (the body's protective proteins found in the blood), to an inactivated     influenza H5 bird flu, virus vaccine. Participants will be assigned by chance to receive     the vaccine injections with and without an adjuvant, (substance that can improve vaccine     effectiveness so less vaccine may be used) MF59, or placebo (inactive substance). Five     different vaccine dose strengths will be evaluated. About 735 healthy participants, ages     18-49 will be asked to take part in this study. Study procedures include physical exam, blood     sampling, and use of a memory aid. Volunteers will participate for up to 13 months.   "
234152|NCT00912509|"     This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal     cross linking system to treat corneal infections.   "
234153|NCT00912522|"     The investigators intend to study the role of the cortex in high- level cognition processes     and sensory adaptation, by the use of non-invasive Transcranial Magnetic stimulation and     various cognitive tests.   "
234154|NCT00912535|"     The objectives of this study are to evaluate the efficacy and safety of quetiapine extended     release tablet versus placebo as adjunct to selective serotonin reuptake     inhibitors/serotonin/norepinephrine reuptake inhibitors (SSRI/SNRI) in the augmentation     treatment of patient with primary anxiety disorders or mood disorders with co-morbid anxiety     symptoms.   "
234155|NCT00912548|"     The purpose of this study is to compare 5-year disease free survival rate (DFS rate) between     the hormone receptor positive breast cancer patients who were added Goserelin to Tamoxifen     for ovarian function suppression after neo-/adjuvant cytotoxic chemotherapy and the hormone     receptor positive breast cancer patients who were treated with Tamoxifen.   "
234156|NCT00912561|"     The purpose of this trial is to study the improvement of cerebral hemodynamics in high risk     stroke patients with impaired Cerebrovascular Reserve (CVR) due to high grade stenosis of the     internal carotid (ICA) or middle cerebral artery (MCA) by Intense Aerobic Exercise (IAEx).   "
234157|NCT00912574|"     Goal: To characterize the cellular events that occur in vivo after vaccination with an     emulsion of GMCSF-in-adjuvant.      Design: Open-label, single dose study in two stages.   "
234158|NCT00912587|"     Ghrelin is a newly discovered peptide that is secreted by the stomach. Its main role is to     stimulate food intake but recent studies indicate that it also acts on the cardiovascular     system to confer beneficial effects. The mechanism of action is unclear but experimental     studies suggest that ghrelin decreases the sympathetic nervous system. Beside there is new     evidence in animal models that ghrelin may also be involved in stress reaction as ghrelin     injection seems to protect against symptoms of stress. Given that circulating levels of     ghrelin are reduced in obesity, this suggests that the effect of ghrelin may differ between     lean and obese subjects. Ghrelin could represent an attractive therapeutic strategy for the     treatment of cardiovascular diseases. The aim of the study if to gain more knowledge of the     effect of ghrelin on the sympathetic nervous system and stress reactivity in both lean and     obese subjects.   "
234201|NCT00920972|"     The hypothesis for this study is that a preparative regimen that maximizes host     immunosuppression without myeloablation will be well tolerated and sufficient for engraftment     of donor hematopoietic cells. It is also to determine major toxicities from these     conditioning regimens, within the first 100 days after transplantation.   "
234202|NCT00920985|"     Birth Control Patch Study   "
234159|NCT00912600|"     Percentage of patients over 80 admitted in ICU varies greatly from one center to another. ICU     admission criteria of older patients are scarcely described and benefit of ICU admission for     those patients is uncertain. In this study, we prospectively studied old patients arriving to     the emergency department of 15 French hospitals with conditions that potentially warrant ICU     admission.The working hypothesis was that ICU admission was associated with a 20% decrease in     six-month mortality.   "
234160|NCT00912613|"     The incidence of PTSD post ICU varies from unit to unit, however a significant number of     patients have been shown to develop this disorder. Many patients do not recall their stay in     ICU properly and yet can clearly recall nightmares, hallucinations or paranoid delusions,     which may be very frightening for the patient to recall at a later stage. As yet, no     interventional studies have had an impact on the development of PTSD in this population of     patients. However, a recent observational multi-centre study suggested that those patients     receiving a diary of their time in ICU had lower levels of symptoms of PTSD than those who     did not. These results need to be verified in the form of a randomized study.   "
234161|NCT00912626|"     The goal of this study is to determine if there is a correlation between an efficacious     family environment and sibling behavior in families with children who are critically ill.   "
234573|NCT00918047|"     Study to evaluate the pharmacokinetics, safety, and tolerability of OXC XR as adjunctive     therapy in pediatric subjects with refractory partial epilepsy.   "
234163|NCT00912652|"     More and more Americans are becoming overweight. The rates of overweight are especially high     in rural areas of the country. Until now, there has been little access to weight management     programs in rural areas. This study will examine ways to help individuals from rural counties     to manage weight and improve fitness. To do this, three doses of lifestyle treatment (Low,     Moderate and High)will be compared to an education control condition. Our principal     hypothesis is that both the Moderate and High conditions will have greater weight loss at two     years than either the Low or Control conditions.   "
234164|NCT00912665|"     Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance     to changes in perfusion pressure. In the eye, several studies have reported that retinal     blood flow is autoregulated over a wide range of ocular perfusion pressures. In the optic     nerve head only few data are available. Large scale studies have shown that reduced ocular     perfusion pressure is an important risk factor for the prevalence, the incidence and the     progression of primary open angle glaucoma.      Former studies that investigated ocular blood flow autoregulation only measured choroidal     blood flow. For the optic nerve head only few data are available, although it seems likely     that it underlies similar autoregulatory mechanisms.      The primary goal of the present study is to gain more insight into these phenomena in humans.      The present study aims to investigate the pressure/flow relationship as a measure for optic     nerve head autoregulation during combined changes of intraocular pressure and arterial     pressure. Intraocular pressure will be increased by the use of a suction cup technique, mean     arterial pressure will be increased by squatting. During the whole procedure, optic nerve     head blood flow will be measured continuously.   "
234165|NCT00912678|"     Kidney transplantation in the elderly is a challenge since patient's co-morbidity and the     decreased injury threshold of older grafts may limit the benefits of transplantation in these     patients. To compare favourable effects between low dose tacrolimus (LD-Tac) and     mycophenolate-mofetil (MMF) in this patient population the investigators conducted a one year     prospective multicenter randomized controlled trial. 90 kidney transplant recipients > 65     years with cadaveric grafts (> 65 years) from 5 centers were enrolled and received baseline     immunosuppression with daclizumab induction (1 mg/kg) at day one and day 14, LD-Tac (trough     level 5-8 µg/ml), MMF (1-2 g/d) and steroids. After three months, patients were centrally     randomized either to MMF (1-2 g/d) and steroids (23 patients) or to LD-Tac and steroids.     Follow-up visits were performed every 4 weeks up to one year. Protocol biopsies were     performed after one year. The investigators' primary hypothesis is that the biopsy proven     rejection rate in the MMF group is not significantly different compared to the LD-Tac group     after one year. The investigators' secondary hypothesis is that graft function in the MMF     group (reflected by the glomerular filtration rate and protocol biopsy result) is superior to     the graft function in the LD-Tac group.   "
234166|NCT00912691|"     The purpose of this study is to determine whether CM-AT is effective in treating the core     symptoms of autism.   "
234167|NCT00912704|"     End-stage renal disease (ESRD) is a healthy, social and economic threat worldwide. In the     past ten years, the incidence and prevalence of ESRD patients have tremendously increased,     ranking at the top in the world. The reasons for such high incidence and prevalence are     multifactor. Early diagnosis and closed monitor of the patients with chronic kidney disease     (CKD) may be beneficial, but not confirmed yet.The advising mechanisms for non-doing or     withdraw long-term dialysis. All these studies will be performed in a multicentered project.     Three medical centers in which CKD researches have been conducted for many years will provide     a large cohort and share the data collected from their own hospitals. We expect that the     results will provide an excellent guideline for CKD care, achieve cost-effectiveness of     dialysis therapy and better life quality of ESRD patients.   "
234168|NCT00912717|"     After informed consent, participants will be asked to complete a medical/family history     questionnaire and provide a blood sample. Some participants may also be asked to provide a     urine sample. Individuals undergoing procedures that require collection of biological samples     for clinical purposes may have these samples saved for research purposes. Participants will     also be asked for their permission for study investigators to access medical records and/or     recontact them for updates to their medical and family histories. Data and biospecimens will     be stored for potential future research projects.   "
234169|NCT00912730|"     This is a single-institution pilot study seeking preliminary evidence of the usefulness of     mobile gamma cameras in patients undergoing sentinel node biopsy for melanoma.   "
234170|NCT00912743|"     This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively     and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to     determine whether olaparib will have a beneficial effect on the patient's cancer by causing a     response and increasing the time it takes for the cancer to progress.   "
234203|NCT00920998|"     To evaluate the effects of food intake on plasma concentration of Z-338 in healthy     volunteers.   "
234171|NCT00912756|"     Recently, Nanto et al. reported that cilostazol effectively prevented restenosis in a     retrospective analysis of 121 femoropopliteal artery lesions in percutaneous transluminal     angioplasty (PTA) patients who had undergone PTA. In a prospective 3-year follow-up study in     127 patients with similar diseases, the patency rate was significantly higher in the     cilostazol group than in the ticlopidine group. It was also found that cilostazol markedly     inhibited restenosis during the first 1-year period following endovascular therapy when     restenosis is most frequently observed. In addition, there have been sporadic reports that     cilostazol was effective in preventing post-stenting restenosis in the coronary artery area.      Based on these results, this multicenter study is going to be conducted to prospectively     evaluate the usefulness of cilostazol in lower limb endovascular therapy.   "
234172|NCT00912769|"     To compare muscle torque recovery between patients under subvastus approach and those under     midvastus approach after total knee replacement   "
234337|NCT00924768|"     The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is     safe (does not cause prolonged cough, shortness of breath or other problems), but causes     changes in sputum cell samples that the scientists can measure. The investigators are also     interested in seeing if the exposure to the endotoxin decreases the body's natural ability to     clear mucus from the lungs.   "
234173|NCT00912782|"     Patients requiring hemodialysis following kidney failure need a form of dialysis vascular     access in order to undergo the dialysis procedure. Dialysis vascular access dysfunction is an     enormous clinical problem. While the best form of vascular access is the arteriovenous     fistula (AVF), its primary problem is early, aggressive cellular ingrowth that leads to poor     maturation of the vessel, preventing its use for dialysis. Strategies to prevent AVF failure     are needed.      Vitamin D is a hormone present in all human bodies and is important for good bone formation     and immune function. There is new information that links vitamin D to the function of our     veins and arteries, which are used in the creation of an arteriovenous fistulae. Our bodies     can make vitamin D and can also get vitamin D from our diet. However, a majority of patients     with chronic kidney disease and end-stage renal disease (ESRD) have low vitamin D levels     (vitamin D deficiency). There are several benefits to correcting low vitamin D levels,     however, it is not know whether correcting low vitamin D in the body will lead to better     function of the vein and artery used for arteriovenous fistulae creation. The main goal of     this pilot study is to examine the role of vitamin D supplementation on AVF maturation and     useability for dialysis. Study results will be used to develop larger studies to examine the     specific effect that vitamin D supplementation has on the vessels used for AVF creation and     whether vitamin D promotes AVF maturation.   "
234174|NCT00912795|"     The purpose of this study is to develop and test a text messaging-based smoking cessation     program for adults who are currently smoking and want to quit, living in Turkey.   "
234175|NCT00912808|"     The purpose of this study is to find out if a medication that increases levels of a brain     chemical called acetylcholine will improve balance and reduce falls in patients with     parkinson's disease who have the problem of very poor balance and are frequently falling or     nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's     dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.   "
234176|NCT00912821|"     Peritoneal dialysis (PD) is an important model of renal replacement therapy for end-stage     renal disease (ESRD) patients. Thus far, evidence for the initiation dosage of PD treatment     is lacking, most patients begin their PD with four 2 L exchanges per day. However, many     patients have their residual renal function at the initiation of PD, an 8 L dialysate per day     will enhance the toxicity of bioincompatible dialysate and increase the economic burden     compared with that of 6 L dialysate per day. Thus, the investigators perform a prospective,     randomized, controlled, multi-center clinical study. The patients initiation of PD treatment     within 6 months are randomized to be assigned to two groups: 6 L of dialysate per day and 8 L     of dialysate per day, follow up will be regularly performed until 96 weeks. Clinical outcomes     such as mortality, complications and life quality between the two groups will be     investigated.   "
234177|NCT00912834|"     To understand the urine analysis of athletes   "
234178|NCT00912847|"     The purpose of this study is:        1. To establish and compare the diagnostic utilities for hepatocellular carcinoma (HCC)          screening tests of (a) HS-AFP, (b) AFP + US,(c) AFP alone and (d) US alone (within HBV          carriers between age 40 and 70 years);        2. To establish the cost-effectiveness of the screening tests;        3. To compare tumor sizes, resection rates, and survival rates up to 18 months between          those who were screened by HS-AFP those of a historical control group that was not          screened.   "
234179|NCT00912860|"     To evaluate the immunogenicity of a serum-free pre-formulated solution of Avonex when given     to interferon beta naive patients with relapsing/remitting multiple sclerosis.   "
234180|NCT00912873|"     This is a research study to determine if the concentration of local anesthetic through a     catheter next to the nerves that go to the hip that is undergoing surgery, affects muscle     strength and sense of touch experienced after surgery. This study is looking at the varying     concentrations of local anesthetic placed through the catheter.   "
234181|NCT00912886|"     The steroid pregnenolone sulfate (PREGS) may be one of the factors responsible for the memory     decline related to normal aging or associated with Alzheimer's disease (AD). The purpose of     this study is to determine whether plasma levels of PREGS are decreased patients with at mild     to moderate AD compared with AD-free control subjects matched for gender and age and to see     whether they are inversely correlated with the severity of memory deficits in AD patients.     The hypothesis is that blood levels of PREGS are decreased with advanced age and with the     stage of AD that would be positively correlated with memory deficits. Therefore PREGS could     be considered as an early marker of the memory deficits in AD.   "
234182|NCT00912899|"     This is a phase 1 study to evaluate the safety and determine maximum tolerated dose, safety &     tolerability of noscapine HCl in patients with advanced multiple myeloma   "
234183|NCT00912912|"     The goal of this clinical research study is to learn if Sutent® (sunitinib malate, SU011248)     can control the disease in patients with germ cell tumors that are resistant to earlier     treatment.   "
234184|NCT00912925|"     This study is being conducted to demonstrate the safety and clinical efficacy of Aldurazyme     treatment in MPS I patients   "
234185|NCT00912938|"     to evaluate whether bone marker can provide the valuable predictor of skeletal complications     and whether regular assessing of NTX(N-telopeptide of type I collagen) and osteocalcin can be     useful in advanced breast cancer patients with bone metastasis receiving zoledronic acid.   "
234186|NCT00912964|"     The study is intended to test efficacy, safety and tolerability of two doses of once daily     (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.   "
234187|NCT00912977|"     Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted     movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of     these movements can range from subtle to extremely debilitating and may or may not interfere     with normal activities such as putting on a coat or brushing ones teeth. The purpose of this     study is to demonstrate the validity and reliability of objectively measuring dyskinesia with     a forceplate.   "
234338|NCT00924781|"     This study will evaluate the efficacy and safety of intravenous MK2578, given as maintenance     treatment for renal anemia in chronic kidney disease patients on dialysis who were previously     receiving erythropoietin stimulating agents.   "
234658|NCT00926705|"     The investigators hypothesize that giving Dexmedetomidine in combination with Fentanyl for     pediatric patients undergoing hypospadias surgery, will reduce the fentanyl requirement for     intraoperative and postoperative analgesia.   "
234188|NCT00920803|"     The primary purpose of this study is to determine the safety and tolerability of SRT501 (5.0     g) in subjects with colorectal cancer and hepatic metastases when administered once daily for     14 days.      The purpose is to also characterize the pharmacokinetic profile of SRT501 (5.0 g) by     assessing levels of SRT501 and metabolites in blood, urine, bile and normal and malignant     metastatic tissues in subjects with colorectal cancer and hepatic metastases when     administered once daily for 14 days.      The secondary purpose is to examine the pharmacodynamics of SRT501 activity in both normal     and malignant tissue samples, including blood and/or bodily fluids.   "
234189|NCT00920816|"     The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in     delaying tumor progression in patients with metastatic renal cell cancer.   "
234190|NCT00920829|"     The overarching aim of this trial is to evaluate naltrexone's efficacy in light of genetic     variation and brain response to alcohol cues utilizing a neuroimaging paradigm. This trial     has four specific aims. First, this trial will evaluate whether the presence of the OPRM1     Asp40 allele substitution is associated with improved treatment response to naltrexone in     treatment-seeking alcoholics. Second, it will evaluate whether there is a difference in the     naltrexone dampening of the alcohol cue-induced brain activation dependent on OPRM1 genotype.     Third, it will explore whether alcohol cue-induced brain activation dampening by naltrexone     might be a mediating factor in the treatment effects of naltrexone, the OPRM1 gene, or their     interaction that might be observed in the first aim. Finally, this trial will evaluate the     effect of medication compliance, or adverse effects, on the observed medication by genotype     treatment response. A secondary aim will measure medication compliance and side effects based     on OPRM1 genotype.   "
234191|NCT00920842|"     RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors     of childhood leukemia who have undergone stem cell transplant may help doctors learn more     about the disease and the long-term effects of leukemia treatment. It may also help improve     the quality of life for future cancer survivors.      PURPOSE: This clinical trial is studying metabolic syndrome in adolescent and young adult     survivors of childhood leukemia who have undergone stem cell transplant.   "
234192|NCT00920855|"     The primary objective of this study is to assess the safety and tolerability of bendamustine     as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma     (MM).   "
234193|NCT00920868|"     The primary purpose of this study is to find the highest tolerated dose of the study drugs:     capecitabine, oxaliplatin, bevacizumab, and dasatinib given in combination to subjects with     advanced solid tumors. This will occur in the first part of the study (Phase I). Once this     dose has been determined, it will be given to subjects with advanced metastatic colorectal     cancer in the second part of the study (Phase II).      By giving these drugs in combination, researchers hope to evaluate the side effects of the     study drugs in both groups, and to determine if this combination could possibly decrease or     stabilize the cancer being treated.      Subjects will be enrolled at Duke University Medical Center (DUMC) and Rocky Mountain Cancer     Center.      After satisfying eligibility and screening criteria, patients will be treated on 21 day     cycles.      ABOUT THE STUDY DRUGS        -  Capecitabine (Xeloda™) is an oral (taken by mouth) chemotherapy drug in tablet form made          by Roche Laboratories Inc. Capecitabine has been approved for use by the Food and Drug          Administration (FDA) for first line treatment (treatment that should be used for cancer          that has not been treated yet) of metastatic colorectal cancer and also for metastatic          breast cancer.        -  Oxaliplatin (Eloxatin™) is an intravenous (given by injection into a vein) chemotherapy          drug made by Sanofi-Synthélabo. This drug is also approved by the FDA for use in          metastatic colorectal cancer.        -  Bevacizumab (Avastin™) is a type of intravenous cancer treatment called anti-angiogenic          therapy (a type of therapy to treat cancer that interferes with blood flow to the tumor,          thereby stopping tumor growth, and possibly leading to tumor shrinkage) made by          Genentech Inc. Bevacizumab is approved by the FDA for first line treatment of metastatic          colorectal cancer in combination with other chemotherapy.        -  Dasatinib (Sprycel™) is an oral drug made by Bristol Myers Squib, Inc (BMS). Dasatinib          is approved by the FDA for the treatment of chronic myeloid leukemia (CML), acute          lymphoblastic leukemia or for patients that are resistant to a medicine called imatinib          mesylate (Gleevec™ ).   "
234194|NCT00920881|"     To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring     System with respect to a reference standard.   "
234195|NCT00920894|"     This study aims to measure the effect of plant stanol esters on serum total and lipoproteins     lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood     lipid concentrations   "
234196|NCT00920907|"     The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab     manufactured by two different processes   "
234197|NCT00920920|"     Background:      The standard treatment of locally advanced cervical cancer is radio-chemotherapy including     external beam radiotherapy (EBRT), brachytherapy (BT) and concomitant chemotherapy with     weekly Cisplatin. While image based conformal EBRT is routinely used, prescription and     reporting of BT is still based on specific dose points defined in 2D. Thus, for several     decades the BT dose has most often been prescribed and reported to the Manchester point A     defined according to different traditions.      Recently, a working group from GEC-ESTRO has published recommendations on contouring of     tumour target and organs at risk (OAR) as well as on dose volume parameters to be reported     for image guided BT in definitive radiotherapy for locally advanced cervical cancer. These     recommendations are mainly derived from retrospective single institution experience with MRI     based intracavitary BT. The major advantage of this technique is the possibility to conform     the dose given by BT with regard to both volume (3D) and time (4D). Thus, by repetitive     imaging performed before each BT implant it is possible adapt the dose given by BT to the     anatomy of each individual patient taking into account not only the position of OAR but also     the tumour regression which often is obtained by preceding EBRT and chemotherapy. Based on     the experience collected so far, the image based BT approach is expected to have a major     impact on the clinical outcome with a concomitant decrease in the rates of both local failure     and morbidity.      Aims:        -  To introduce MRI based 3D-4D BT in locally advanced cervical cancer in a multicenter          setting within the frame of a prospective observational study.        -  To establish a bench-mark for clinical outcome with image based BT in a large patient          population with respect to local control, survival, morbidity and QoL        -  To establish a reference material with regard to image based DVH parameters according to          the guidelines from the GEC ESTRO working group.        -  To correlate image based DVH parameters for CTV and for OAR with outcome        -  To develop prognostic and predictive statistical models for clinical outcome including          volumetric, dosimetric, clinical and biological risk factors        -  To establish radiobiological parameter estimates that will allow a precise risk          estimation in individual patients and aid in the development of new treatment protocols   "
234198|NCT00920933|"     This study will assess the ability of AIN457 to attenuate the increase in airway neutrophils     that is seen following ozone exposure. Healthy subjects will be treated with AIN457, placebo,     or oral corticosteroid and the response to a subsequent ozone exposure will be evaluated.   "
234199|NCT00920946|"     The purpose of this study is to determine if Dimebon is safe and effective for the treatment     of cognitive impairment in Huntington disease.   "
234204|NCT00921011|"     The study hypothesis (or theory) is that monthly loss of iron before menopause may reduce     women's risk of hardening of the arteries, or atherosclerosis.      This study uses noninvasive, noncontrast magnetic resonance imaging (MRI) of arteries in     women entering menopause. This will help to determine if there is a correlation between iron     accumulation and hardening of the arteries. In addition, blood levels of hormones will be     measured to help show differences due to hormone levels vs. iron accumulation.   "
234207|NCT00921050|"     Some recommendations of expert consensus on subclinical hypothyroidism (SH) are controversial     in those areas with not enough information to reach a conclusion, such as not recommending     treatment with thyrotrophic hormone of 4-10 mUI/L and free thyroxin in normal range. The body     changes or symptoms at this stage are often mistaken as aging. There are studies showing     significant changes in heart (slow rate, lower ejection fraction, diastolic dysfunction);     hypercholesterolemia, dysfunction cognitive abilities (memory attention…).      The prevalence of SH increases with age, reaching 14% over 65 years old. This age group     increase as the population ages highlights the need for evidence to improve recommendations     for the elderly.      NEUROPSI is a validated neuropsychological test sensible for mild cognitive alterations. It     can be applied to individuals with little schooling.      This study aims to determine positive change in cognitive abilities (NEUROPSI), ejection     fraction, and body percent of lean and adipose tissue without adverse effects, placebo versus     thyroxin supplement to keep thyroid-stimulating hormone (TSH) between 0.5-2.5 mUI/L in     elderly with TSH 4-10 mIU/L.   "
234208|NCT00921063|"     The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to     placebo in the treatment of Generalized Anxiety Disorder in an adult population   "
234209|NCT00921076|"     Surgical options for managing hindfoot arthritis include: joint fusion, total ankle joint     replacement or osteotomies (realignment) of bones. Fusion of arthritic hindfoot joints has     been the accepted method of managing hindfoot arthritis for over a century. Recently, total     ankle replacement has evolved as a treatment option for patients with end stage ankle     arthritis. A comparison of gait for patients before and after hindfoot fusion or total ankle     replacement will give further information about the outcome of this treatment. The principal     aim of this project is to assess the effect of total ankle replacement or hindfoot fusion on     gait. We are also interested in the outcome of the surgery and its effect on your symptoms     (eg. pain and mobility). The results of this study will aid researchers in assessing this new     treatment modality. Your involvement in this study is critical for the researchers to further     analyze this new form of treatment and your time and involvement is appreciated.   "
234210|NCT00921089|"     The aim of this cross-sectional study is to determine the correlation of coronary artery     calcification as measured by electron-beam computerized tomography and coronary flow reserve     measured by trans-thoracic Doppler echocardiography in hemodialysis patients. The     investigators also assessed the carotid artery parameters by measuring intima media thickness     that can accurately describe the process of arterial wall changes due to atherosclerosis.     Possible association of coronary flow reserve with inflammation and arterial calcification in     hemodialysis patients was also evaluated.   "
234211|NCT00921102|"     The aim of this study is to assess the efficacy of atropine in preventing nausea and vomiting     after spinal anesthesia with local anesthetic and morphine for elective Caesarean section.      Patients enrolling in the study will be assigned to one of three groups. One will receive a     small dose of intrathecal atropine; another will receive small-dose intravenous atropine; the     third group will receive placebo.   "
234212|NCT00921115|"     This study is being done to test the safety and effectiveness of two drugs, Anastrozole and     Fulvestrant, used as combined therapy in the neo-adjuvant setting for hormone receptor     positive invasive breast cancer.   "
234213|NCT00921128|"     Background:        -  Parkinson s disease (PD) is a progressive neurodegenerative disorder that affects the          brain cells that make the chemical dopamine. The primary medical treatment for PD has          been to use medications to replace the dopamine that is missing from the brain. These          medications can be effective at first, but after many years side effects and tolerance          develop.        -  Surgery can treat basic PD symptoms and complications. Deep brain stimulation (DBS)          offers a safer alternative as the therapy can be adjusted and reversed to minimize side          effects and optimize beneficial effects. DBS treats the symptoms of PD but does not          alter its course.        -  Infusions of neurochemicals or medications are another PD treatment method. NIH          researchers have developed the technique of convection-enhanced delivery, which very          precisely and consistently delivers infusions of many types into the brain. This project          will allow researchers to infuse a medication, Muscimol, into the subthalamic region of          the brain to see if it is as safe and effective as DBS.      Objectives:        -  To determine whether an infusion of Muscimol into the brain is safe and relieves the          symptoms of Parkinson s disease.        -  To demonstrate that the infusion can be monitored with magnetic resonance imaging (MRI)          using gadolinium.      Eligibility:        -  Patients 18 years of age and older who have Parkinson s disease and are preparing for          bilateral subthalamic nucleus (STN) DBS surgery.        -  Patients will be divided into two groups. One group of patients will have a partial          infusion of Muscimol into the STN, and the second group of patients will have complete          infusion of Muscimol into the STN.      Design:        -  This study will begin 5 days before the patient undergoes bilateral subthalamic DBS          surgery.        -  On Day 1 of the study, small thin tubes (microcatheters) will be inserted into the STN          through the same incision and burr holes that are used for DBS. Two infusion studies of          Muscimol will be performed on successive days: the first without PD medication (Day 3 of          study) and the second with PD medication (Day 4 of study).        -  Each infusion will be monitored in the MRI suite, and researchers will perform clinical          examinations of patients PD symptoms.        -  Following the study experiments, a second surgery will be performed to remove the          microcatheters and to place DBS electrodes in the standard fashion.   "
234214|NCT00923000|"     The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and     morphine with traditional Chinese herbs in healthy volunteers.   "
234215|NCT00923013|"     Background:      Hairy cell leukemia (HCL) is highly responsive to but not curable by cladribine (CdA). HCL     responds to rituximab, which is not yet standard therapy for HCL.      Patients with the CD25-negative variant (HCLv) respond poorly to initial cladribine but do     respond to rituximab in anecdotal reports.      Deoxycytidine kinase phosphorylates cladribine to CdATP, which incorporates into DNA, leading     to DNA strand breaks and inhibition of DNA synthesis. Rituximab is an anti-CD20 monoclonal     antibody which induces apoptosis and either complement or antibody dependent cytotoxicity     (ADCC or CDC).      Patients in complete remission (CR) to cladribine have minimal residual disease (MRD) by     immunohistochemistry of the bone marrow biopsy (BMBx IHC), a risk for early relapse. Tests     for HCL MRD in blood or marrow include flow cytometry (FACS) or PCR using consensus primers.     The most sensitive HCL MRD test is real-time quantitative PCR using sequence-specific primers     (RQ-PCR).      In studies with limited follow-up, MRD detected by tests other than RQ-PCR can be eliminated     by rituximab after cladribine in greater than 90 percent of patients, but MRD rates after     cladribine alone are unknown. Simultaneous cladribine and rituximab might be superior or     inferior to delaying rituximab until detection of MRD.      Only 4 HCL-specific trials are listed on Cancer.gov: a phase II trial of cladribine followed     4 weeks later by 8 weekly doses of rituximab, and phase I-II trials of recombinant     immunotoxins targeting CD22 (BL22, HA22) and CD25 (LMB-2).      Objectives:      Primary:      To determine if HCL MRD differs at 6 months after cladribine with or without rituximab     administered concurrently with cladribine.      Secondary:        -  To compare cladribine plus rituximab vs cladribine alone in terms of 1) initial MRD-free          survival and disease-free survival, and 2) response to delayed rituximab for relapse, to          determine if early rituximab compromises later response.        -  To determine if MRD levels and tumor markers (soluble CD25 and CD22) after cladribine          and/or rituximab correlate with response and clinical endpoints.        -  To determine, using MRD and tumor marker data, when BMBx can be avoided.        -  To compare response and MRD after the 1st and 2nd courses of cladribine.        -  To evaluate the effects of cladribine and rituximab on normal T- and B-cells.        -  To enhance the study of HCL biology by cloning, sequencing and characterizing monoclonal          immunoglobulin rearrangements.      Eligibility:      HCL with 0-1 prior courses of cladribine and treatment indicated.      Design:      Cladribine 0.15 mg/Kg/day times 5 doses each by 2hr i.v. infusion (days 1-5)      Rituximab 375 mg/m2/week times 8 weeks, randomized half to begin day 1, then repeat for all     patients with blood-MRD relapse at least 6 months after cladribine. Also may repeat for those     with blood-MRD relapse at least 6 months after delayed rituximab.      MRD tests used for the primary objective will be limited to BMBx IHC, blood FACS or blood     consensus PCR, all CLIA certified. Blood MRD relapse is defined as FACS positivity or low     blood counts (ANC less than 1500/microl, Plt less than 100,000/microl, or Hgb less than 11).      Stratification: 68 patients with 0 and 62 with 1 prior course of cladribine.      Statistics: 80% power to discriminate rates of MRD of 5 vs 25%, or 10 vs 35%      Non-randomized arm: 20 with HCLv will begin rituximab with cladribine.      Accrual Ceiling: 152 patients (130 HCL, 2 extra HCL if needed, and 20 HCLv.)   "
234216|NCT00923026|"     Background:      The NCI Surgery Branch has developed experimental therapies that involve taking white blood     cells from patients' tumor or from their blood, growing them in the laboratory in large     numbers, and then giving the cells back to the patient.      Objective:      This study will allow patients to be followed for up to 15 years following treatment on an     NCI Surgery Branch Gene Therapy Trial as required by the FDA.      Eligibility:      Patients must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol      Design      Patients will be followed with a physical examination and blood tests for up to 15 years as     required by the FDA   "
234558|NCT00917839|"     This study is designed to evaluate the neuroprotective effect of lamotrigine in the     combination of interferon beta 1a once weekly intramuscular in patients with     relapsing-remitting multiple sclerosis.   "
234217|NCT00923039|"     Small body size at birth, slow weight gain during infancy and increase in body mass index     after 2 years are independent risk factors for cardiovascular disease and the metabolic     syndrome. There is a large gap in our understanding of how early growth affects the     cardiovascular system. Possible mechanisms include alterations in body composition, in     cardiac structure, in vascular function, in renal function and epigenetic processes.      The Objective is to determine how size at birth and growth during infancy and childhood     affect: body composition, cardiac structure and function, vascular and endothelial function,     renal function, metabolic status and transcriptional and epigenetic characteristics.   "
234956|NCT00922987|"     Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is     used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce     seizure frequency.   "
234218|NCT00923052|"     Background:        -  Researchers are trying to learn what causes certain types of cancer to spread to other          organs in the body (metastasis). Cancer tumors may produce a very small number of          specific cells (cancer stem cells) that cause the tumors to grow in other organs          throughout the body.        -  By examining cancer tumor tissue, normal tissue, blood, bone marrow, and other body          fluids, researchers may determine whether these samples contain cancer stem cells.          Cancer stem cells may provide information on whether the cancer will come back or spread          before other routine x-ray studies or lab tests indicate its presence.      Objectives:        -  To acquire a collection of solid organ cancer stem cells for future study.        -  To analyze solid organ cancer stem cells from various types of cancer on a genetic          level.        -  To determine if solid organ cancer stem cells are present in the blood or bone marrow.      Eligibility:        -  Patients 16 years of age and older who have solid organ cancer (cancer in the liver,          colon, rectum, anus, pancreas, stomach, breast, skin, muscles, fat, connective tissue,          uterus, ovary, cervix, vagina, vulva, or inner lining of the abdomen) or a precancerous          growth, and who are scheduled to have a biopsy or surgery to remove the cancer as part          of their treatment.      Design:        -  This is a prospective trial designed to procure solid organ cancer stem cells before          either surgery or biopsy.        -  All patients registered to this trial will undergo surgery to extirpate their cancer in          the NCI        -  Prior to surgery or biopsy, 8 tablespoons of blood will be drawn.        -  During the surgery or biopsy, a sample of normal tissue will be removed along with the          cancerous or precancerous tissue. If separate consent is given, samples of bone marrow          will also be taken.        -  After discharge, patients will return to the clinic for routine visits every month for          the first 3 months following surgery, and then about every 3 months for 2 years, and          then every 6 months for 3 years. During the visits, patients will have routine blood and          imaging studies done, and researchers will take additional blood samples (about 8          tablespoons at each visit) and optional bone marrow samples (4 teaspoons every 6 months)          to be used for research.   "
234219|NCT00923065|"     This study provides cancer care through the National Cancer Institute's Medical Oncology     Branch (MOB) to patients who are not enrolled in an active treatment research protocol.     Patients receive standard treatments only; no investigational therapies are provided on this     protocol.      Patients 18 years of age and older may be eligible for this protocol. Candidates are patients     for whom an NCI investigator decides that the interests of the patient and the NCI are best     served by the patient's enrollment in this protocol to receive care and follow-up within the     MOB. This includes patients in the following categories:        -  Patients previously enrolled in NCI trials whose participation in this protocol may          continue to provide researchers important scientific information        -  Patients who will be eligible for a research protocol within the foreseeable future        -  Patients whose medical welfare will be seriously compromised by referral back to the          community, such as patients with a rare or complex disease for which community resources          are inadequate or unavailable        -  Terminally ill patients who have received most of their specialized medical care at the          Clinical Center and for whom humanitarian considerations dictate that they continue to          receive their medical care at NIH after going off study for the remaining weeks or          months of life        -  Patients with cancer or HIV, or people at risk for cancer or HIV for whom cancer          treatments at the NCI are requested through the MOB consult service        -  Patients who are participating in a non-treatment NCI research protocol and require          standard-of-care therapy        -  Patients with cancer or HIV or people at risk for cancer for whom cancer treatment or          management at the NCI would add significant value to the institute's cancer training          program      Participants receive standard medical care, including periodic routine laboratory tests,     diagnostic x-rays, and nuclear medicine scans to monitor the course of illness and the     effects of any treatment.   "
234220|NCT00923078|"     The purpose of this study is to determine whether computer-based training of auditory and     visual processing results in corresponding improvement in brain function in individuals with     schizophrenia.   "
234221|NCT00923091|"     This study is to determine the change in blood pressure from the administration of     Olmesartan/Amlodipine/Hydrochlorothiazide triple combinations compared to dual combinations     with Olmesartan/Amlodipine.   "
234222|NCT00923104|"     Background:        -  Blister fluid contains many of the same biomarkers (substances that can be used to          determine the effects of certain kinds of treatments) as blood and urine samples,          particularly regarding changes in the skin.        -  The Radiation Oncology Branch and others are conducting research studies that require          blood and urine samples from healthy volunteers and from patients with cancer. In          addition to these samples, researchers would like to collect the fluid from blisters to          examine markers of inflammation in the skin.      Objectives:        -  To compare blood, urine, and blister fluid samples of patients with cancer who are          undergoing radiation therapy to that of volunteers without cancer who will not be          receiving radiation therapy.        -  To gather more information about the effects of radiation therapy on the skin and body          fluids of individuals.      Eligibility:        -  Patients 18 years of age and older who will be receiving radiation therapy for either          breast or prostate cancer.        -  A separate group of healthy volunteers will also participate in this study.      Design:        -  Physical examination and blood samples to determine eligibility for the study.        -  Blister induction, conducted before the start of radiation treatment, at completion of          radiotherapy (last day of treatment), and at a visit 12 months after the end of          radiation treatment.        -  Blisters will be created through the use of a suction blister device on the hip (for          patients with prostate cancer) or on the treated breast or location of removed breast          (for patients with breast cancer).        -  Blisters will take approximately 30 minutes to form, and fluid will be removed with a          needle and syringe.        -  Blood and urine samples will also be collected at this time.        -  Radiation treatment for breast or prostate cancer will be conducted according to          standard procedures, or as directed by a separate research protocol.        -  Evaluations during the treatment period:        -  Physical examination, including vital signs and body weight checks, and pregnancy test          for women who can become pregnant.        -  Blood and urine tests.        -  Disease evaluation.        -  Post-treatment evaluations:        -  Clinic visits at months 1, 3, 6, 9, and 12 after the end of radiation therapy for          physical examination and disease assessment.        -  Study will end 1 year after the final radiation treatment, upon the collection of the          final (third) blister fluid sample.   "
234223|NCT00923117|"     Background:      One way tumors are able to grow is by forming new blood vessels that supply them with     nutrients and oxygen.      Sunitinib blocks certain proteins on the surface of tumor and blood vessel cells that are     involved with the formation of new blood vessels.      Blocking these proteins may prevent the tumor cells or blood vessels from continuing to grow.      Objectives:      To determine whether sunitinib can cause tumors to shrink or stabilize in patients with     recurrent brain cancer.      Eligibility:      Patients 18 years of age or older with brain cancer whose disease has worsened after standard     treatment with surgery, radiation.      Design:      Patients take a sunitinib pill once a day in 4-week treatment cycles. Treatment may continue     as long as the tumor remains stable or decreases in size and the side effects of treatment     are tolerated.      Routine blood tests are done every 2 weeks during the first 8 weeks of treatment and then     every 4 weeks after that.      Magnetic resonance imaging (MRI) scans are done before starting treatment (at baseline) and     at the end of every 4-week cycle to monitor tumor growth.      Positron emission tomography (PET) scans are done at baseline and at the end of the first     cycle.      Neurological and physical examinations are done at baseline, at week 2 of treatment and at     the end of every treatment cycle.      Health-related quality of life is assessed every 4 weeks.      Pregnancy tests, electrocardiograms and echocardiograms are repeated as needed.   "
234243|NCT00923416|"     The goal of this study is to identify any side effects caused by the implanting of markers     via the rectum. The investigators will also try to determine if any other factors (such as     the position of the markers) influence the risk of side effects. The study procedures consist     of two questionnaires:The first will be completed immediately after the marker implantation     and the second questionnaire will be completed during your radiotherapy planning.   "
234559|NCT00917852|"     TAG 08-02 is a prospective, multicenter, single-arm study to evaluate the use of the CTAG     Device in traumatic transection of the descending thoracic aorta.   "
234339|NCT00924794|"     This is a register-based, epidemiological study of HPV type distribution in women aged 18     years and above with recurrent conization following a primary conization for high grade     lesions/ microinvasive carcinomas. This study will involve data collection from different     databases in the Cancer Registry of Norway.   "
234340|NCT00924807|"     The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be     administered at the same time as standard treatment, which includes hormonal therapy and     external beam radiotherapy.   "
234224|NCT00923130|"     Background:        -  Substantial preclinical antitumor synergy supports the exploration of the combination of          antiangiogenic compounds (including sunitinib and bevacizumab) plus ixabepilone. In          Vivo, synergistic activity between ixabepilone and bevacizumab has been demonstrated          using the 151-B human renal carcinoma xenograft model and this synergy compares          favorably with other antiangiogenic inhibitors (i.e. sunitinib).        -  Combination therapies of bevacizumab with chemotherapy demonstrated improved benefit          compared with single-agent cytotoxics in multiple animal models and in humans.        -  Clinical activity of both compounds used as single agents has been demonstrated in a          broad spectrum of solid tumors. Bevacizumab and ixabepilone, when used as a single          agent, have demonstrated substantial activity in renal cell carcinoma.        -  Phase II studies with bevacizumab and ixabepilone suggest the absence of overlapping          toxicities.        -  Development of a well-tolerated and active bevacizumab/ixabepilone combination has the          potential to further improve the treatment of metastatic renal cell carcinoma (mRCC),          and could represent a second-line option after sunitinib or sorafenib are no longer of          benefit or are intolerable.      Primary Objectives:        -  Determine the objective response rate of the combination of ixabepilone and bevacizumab          in patients with relapsed or refractory mRCC.        -  Determine progression-free survival.        -  Characterize the toxicity of the combination of ixabepilone and bevacizumab in patients          with mRCC.        -  Determine changes in biomarkers and evaluate correlation with clinical outcomes.      Eligibility:        -  Pathologic confirmation of renal cell carcinoma (clear cell histology) by the Laboratory          of Pathology, National Cancer Institute (NCI), or the Medical University of South          Carolina.        -  Presence of metastatic renal carcinoma, after progression or intolerance to Vascular          endothelial growth factor receptor (VEGFR) inhibitors (sunitinib and/or sorafenib).        -  Adequate organ and bone marrow function.      Design:        -  Multi-center, open labeled phase II study        -  Following a Simon two-stage optimal design, a maximum of 58 patients with metastatic RCC          will be accrued.        -  Ixabepilone will be administered daily as a one hour infusion on five successive days          (daily x 5), every three weeks (one cycle equals 3 weeks or 21 days +/- 5 days).          Following cycle 6, cycles will be spread out to 4 weeks or 28 days +/- 5 days. The          starting dose will be a daily dose of 6 mg/m(2)/day, for a total per cycle dose of 30          mg/m(2).        -  In addition, 15 mg/kg bevacizumab will be administered intravenously on day 1 of each          cycle. The first infusion of bevacizumab will be 90 minutes in duration, the second 60          minutes in duration, and in all subsequent cycles bevacizumab will be infused over 30          minutes if prior infusions are well tolerated.   "
234225|NCT00923156|"     In addition to the blood pressure lowering effects of aliskiren, it may have beneficial     effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue     level. An increase of angiotensin II is associated with progression of heart failure.     Although the use of ACE-inhibitors in heart failure shows clinical benefit, an increase in     angiotensin II due to an angiotensin II escape phenomenon is not desirable. It is not yet     known if a direct renin inhibitor can reduce or even prevent the angiotensin II escape     phenomenon associated with the use of an ACE-inhibitor. Therefore the study tested the     effects of ramipril, aliskiren and the combination of both on levels of angiotensin II in the     blood in patients with systolic heart failure   "
234226|NCT00923169|"     Background:        -  GC1008 is a genetically engineered antibody designed to block the activity of          transforming growth factor-beta (TGF-beta). Although TGF-beta has some normal and          beneficial effects in the body, it is often over-produced in malignant melanoma tumors,          and it can help the melanoma grow and spread.        -  Part 1 of this study enrolled 22 subjects with malignant melanoma or kidney cancer to          determine the highest safe dose of GC1008, which was found to be 15 mg/kg.        -  Three of 22 patients with malignant melanoma in Part 1 of the study developed skin          problems, but it is not known if these problems were related to the administration of          GC1008.      Objectives:      -To determine the frequency of adverse skin side effects of GC1008 in patients with malignant     melanoma.      Eligibility:      -Patients 18 years of age and older with malignant melanoma for whom previous treatment was     not successful.      Design:        -  GC1008 is given intravenously (through a vein) at a dose of 15 mg/kg or 10 mg/kg for          four doses on study days 0, 28, 42 and 56 (one treatment cycle). Patients whose cancer          responds to GC1008 may receive one or two additional treatment cycles of four doses          given every two weeks.        -  Physical exam and vital signs on study days 1, 14, 28, 42, 56, 84 and 140.        -  Vitals signs on study days 0, 14, 28, 42, 56, 84 and 140.        -  Frequent blood sample collections for routine safety tests, measurement of blood levels          of GC1008, analysis for antibodies against GC1008 and for research studies.        -  CT or MRI scan, bone scan and PET CT scan before treatment and on study day 84 and 140.        -  Biopsy of apparently normal skin before treatment and again on day 84.        -  Review of medicines and well being on study days 0, 14, 28, 42, 56, 84, 112 and 140.        -  Follow-up visits every 3 months for up 2 years for patients who have not received          additional treatment for their cancer. Evaluations include physical exam, CT or MRI          scan, PET CT scan, blood tests and possibly tumor biopsies....   "
234227|NCT00923182|"     The primary objective of this study is to confirm the safety profile of alemtuzumab 30 mg     (the US/European Union (EU) approved dose) in Japanese patients with relapsed or refractory     Chronic Lymphocytic Leukemia (CLL).   "
234228|NCT00923195|"     Background:        -  Melanoma antigen recognized by T-cells (MART-1) and gp100 are two genes found in          melanoma cells. An experimental procedure developed for treating patients with advanced          melanoma uses these genes and a type of virus to make special cells called anti-MART-1          and anti-gp100 cells, which are designed to destroy the patient's tumor. The cells are          created in the laboratory using the patient's own tumor cells or blood cells.        -  The procedure also uses one of two vaccines-the anti-MART-1 peptide or the anti-gp100          peptide-to stimulate cells in the immune system that may increase the effectiveness of          the anti-MART-1 and anti-gp100 cells. Both vaccines are made from a virus that is          modified to carry a copy of the MART-1 gene or gp100 gene. The virus cannot cause          disease in humans.      Objectives:      - To evaluate the safety and effectiveness of anti-MART-1 and anti-gp100 cells and peptide     vaccines for treating patients with advanced melanoma.      Eligibility:      - Patients 18 years of age with metastatic melanoma for whom standard treatments, including     aldesleukin (IL-2) therapy to boost immune response, have not been effective.      Design:        -  Participants have an initial evaluation with complete medical history, as well as scans,          x-rays, and other tests as directed by researchers. Most of the treatments for this          study will be given on an inpatient basis.        -  Before the treatment begins, participants will undergo leukapheresis (removal of          selected blood cells) to obtain cells for preparing the anti-MART-1 and anti-gp100          cells, and for later stem cell transplantation.        -  Preinfusion treatment: 5 days of chemotherapy and 2 days of total-body irradiation to          prepare the immune system for receiving the anti-MART-1 and anti-gp100 cells.        -  Infusion of cells, followed by IL-2 treatment to improve immune response. IL-2 is given          as a 15-minute infusion through a vein every 8 hours for a maximum of 15 doses (over 5          days).        -  After the cell infusion, participants will be divided into two groups and will receive          either the gp100 peptide or MART-1 vaccine, given once a week for 3 weeks. Participants          will also have stem cell transplantation (from previously collected stem cells) to          promote cell survival.        -  Periodic follow-up clinic visits after hospital discharge for physical examination,          review of treatment side effects, laboratory tests and scans every 1 to 6 months.   "
234229|NCT00923221|"     Background:        -  It is not fully understood why prostate cancer in some men becomes androgen-independent          (no longer responds to anti-androgen medication), but genetics likely plays an important          role.        -  Genes contain the hereditary information that is passed down from parents to children.          Although everyone has the same set of genes, individuals can have different forms of the          same gene.        -  Differences in genes may explain, at least in part, why some people develop a more          aggressive form of prostate cancer than others.      Objectives:      -To obtain blood samples from patients with prostate cancer to try to identify gene     differences associated with progression to the androgen independent state.      Eligibility:      -All patients participating in NCI prostate cancer protocols.      Design:        -  Patients with prostate cancer are evaluated in the NCI s Medical Oncology Clinic.        -  Blood samples are collected at the initial visit or at follow-up visits.        -  DNA (genetic material) and white blood cells are extracted from these samples to be used          for genotyping and establishment of cell lines.        -  Gene variations are correlated with prostate cancer prognosis and prognostic indicators.   "
234230|NCT00923234|"     The hypothesis of this study is that 5-aza and lenalidomide act synergistically in MDS and     AML patients with chromosomal abnormalities involving monosomy 5 or del5q. Therefore, this     phase I study will investigate the maximum tolerated dose (MTD) of lenalidomide in     combination with a fixed dose of 5-aza in this patient population.   "
234598|NCT00925704|"     To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on     the pharmacokinetics of oral calcitriol (ROCALTROL)   "
234231|NCT00923247|"     Background:        -  The combination of anti-cancer drugs vandetanib (given orally) and bortezomib (given          intravenously) has not been used in humans. However, both drugs have been studied          separately. Bortezomib has been approved by the U.S. Food and Drug Administration (FDA)          for treating multiple myeloma and mantle cell lymphoma, while vandetanib is still under          investigation pending FDA approval.        -  Both bortezomib and vandetanib are under investigation for use in treating certain kinds          of cancer. Researchers hope that the combination of these two drugs will be more          effective than either of them alone.      Objectives:        -  To determine if the combination of vandetanib and bortezomib will decrease the amount of          the cancer and, if it does, to determine how long the response will last.        -  To determine any side effects that may occur with this combination of treatments.        -  To determine what doses of each drug are well tolerated and safe when given together.        -  To study genetic mutations in tumors to better understand how tumors grow and how these          drugs interact with the tumor.      Eligibility:        -  Patients 18 years of age and older with solid tumors that cannot be surgically removed          and have either recurred or shown further growth. The tumor(s) must be able to be          evaluated by X-ray, MRI (magnetic resonance imaging), and CT (computerized tomography)          scanning.        -  Patients who have been diagnosed with medullary thyroid cancer will participate in Phase          II of the study.      Design:        -  Tumor samples may be taken at the start of the study for research purposes.        -  Phase I: Patient groups will be treated on an outpatient basis with vandetanib and          bortezomib, given at increasing doses over four different levels to determine the          maximum tolerated dose calculated by height and weight:        -  Doses will be given on Days 1, 4, 8, and 11 for each 28-day cycle.        -  Two additional levels (Level 1A and Level 1B) may be included in the study, depending on          side effects at various levels.        -  Phase II: Patients with medullary thyroid cancer will be divided into two groups, with          two patients in Group A for every one patient in Group B. No placebo will be involved in          this study.        -  Group A: Patients will be treated with vandetanib and bortezomib at the maximally          tolerated dose of the Phase I study.        -  Group B: Patients will be treated with bortezomib alone.        -  A second tumor sample may be taken. In patients with thyroid cancer, the second biopsy          will be done at the 6-week evaluation (approximately 42 days after beginning). In          patients with cancer other than thyroid cancer, the second biopsy will be obtained on          Day 4 of either the first or second cycle, after the bortezomib infusion.        -  The effects of the drugs will be studied through blood samples and CT scans taken during          and after various drug cycles.   "
234232|NCT00923260|"     The aim of the present study was to evaluate the additional effect of sudden visceral fat     reduction by omentectomy on Metabolic Syndrome, acute phase reactants and inflammatory     mediators in patients with morbid obesity undergoing Laparoscopic Roux-en-Y Gastric Bypass.   "
234233|NCT00923273|"     Background:      The drug pemetrexed is used to treat non-small cell lung cancer (NSCLC) that does not respond     to standard therapy or that has recurred after standard therapy; however, only 9 in 100     patients respond to pemetrexed.      Sirolimus is a drug that blocks a protein in cells called mammalian target of rapamycin     (mTOR). In cancer cells, mTOR is active when it should not be, allowing the cells to grow     uncontrollably. This protein is unusually active in many cases of NSCLC. By blocking the     activity of mTOR, sirolimus may make the cancer cells more responsive to treatment with     pemetrexed.      Objectives:      To determine if sirolimus in combination with pemetrexed is safe and well tolerated in     patients with NSCLC.      To determine the highest safe dose of pemetrexed combined with sirolimus.      To look at the ability of sirolimus and pemetrexed to fight NSCLC.      To learn how the body eliminates sirolimus and pemetrexed.      Eligibility:      Patients 18 years of age and older with NSCLC whose disease does not respond to standard     therapy or has recurred after treatment with standard therapy.      Design:      Biopsy before treatment starts, if the tumor is easy to reach by bronchoscopy or can be done     by needle biopsy. This procedure is optional.      Drug treatment, as follows:        -  Day 1: Intravenous (through a vein) infusions of pemetrexed. Small groups (3 to 6) of          patients are given pemetrexed at a certain dose level. If the first group experiences no          significant side effects, the next group receives a higher dose. This continues in          succeeding groups for up to five dose levels until the maximum tolerated study dose          (highest dose that patients can be given safely) is determined.        -  To lessen the side effects of pemetrexed, patients also receive a Vitamin B12 injection          every 21 days, folic acid tablets daily, and dexamethasone tablets twice a day the day          before, the day of, and the day after pemetrexed infusions.        -  Days 1-21: Sirolimus tablets by mouth.      Evaluations during the treatment period:        -  History and physical examinations, blood and urine tests, electrocardiogram.        -  Disease evaluation with computed tomography (CT), positron emission tomography (PET) or          magnetic resonance scans (MRI) scans....   "
234234|NCT00923299|"     RATIONALE: Monoclonal antibodies, such as cetuximab and trastuzumab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Giving cetuximab     together with trastuzumab may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of trastuzumab when     given together with cetuximab and to see how well it works in treating patients with     metastatic pancreatic cancer that progressed after previous treatment with gemcitabine.   "
234235|NCT00923312|"     This is a phase I/IIa open, uncontrolled, international, prospective clinical trial, in an     out-patient setting, in patients with stage IIIB/IV NSCLC.      The phase I part of the study consists of a dose escalation phase, in which the recommended     dose (RD) for the phase IIa part of the study will be established based on the incidence of     dose-limiting toxicities (DLT). In the phase IIa part of the study, additional patients will     be included at the RD, to confirm the safety and explore the activity of that dose.      This study will take place in Switzerland (2 sites) and Germany (11 sites).   "
234236|NCT00923325|"     Background:        -  This study is a companion biology study to NIH protocol 08-C-0080, A Phase II Trial of          R1507, a Recombinant Human Antibody to the Insulin-Like Growth Factor-1 Receptor for the          Treatment of Patients with Recurrent or Refractory Ewing s Sarcoma, Osteosarcoma,          Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas.        -  Analysis of tumor tissue and blood samples from patients with sarcomas who are receiving          treatment with the experimental drug R1507 may help elucidate the biology of sarcomas          and how they respond to certain therapies with monoclonal antibodies.      Objectives:        -  To study the effect over time of R1507 on the proteins and cells in the blood and tissue          of patients with sarcoma in order to learn more about how patients respond to the          treatment and what changes occur in their cells.        -  To discover possible new treatments for cancer.      Eligibility:        -  Participants in NIH protocol 08-C-0080 for the study of R1507 to treat people with          various sarcomas.      Design:        -  Patients who previously agreed as part of protocol 08-C-0800 to have blood sampling for          pharmacodynamic studies (blood draws to test blood for levels of R1507 and how the body          affects R1507) will not have any additional blood drawn as part of this study.        -  Patients who did not previously agree to pharmacodynamic sampling as part of the          protocol 08-C-0800 will be asked to give 6 blood samples at various time periods during          the study.        -  Pathology slides or tissue blocks obtained under protocol 08-C-0800 will be forwarded to          F. Hoffmann-La Roche laboratories for analysis.   "
234237|NCT00923338|"     This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal     fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.   "
234244|NCT00923429|"     A randomized controlled trial over a 10-week period with a two-year follow-up. The objectives     were to compare effects of manual therapy in addition to the stay-active concept versus the     stay-active concept only in low back pain patients recruited from primary health care. 160     outpatients with acute or subacute low back pain with or without pain radiation into the legs     (70 women, 90 men, ages 20-55 years) were recruited from a geographically defined area and     randomly allocated to stay-active care with or without muscle stretching, or to manual     therapy with or without specific corticosteroid injections in addition to the stay-active     concept. Pain, disability rating index, and sickness absence measures were used as outcome at     10-week follow-up and sickness absence was measured at two-year follow-up.   "
234238|NCT00923351|"     Background:        -  Pediatric solid tumors (Ewing's sarcoma, rhabdomyosarcoma, and neuroblastoma) are often          difficult to cure with standard treatment.        -  Immune therapy using an experimental vaccine made from proteins from the patient's tumor          cells may boost the body's immune response against the tumor.        -  The effects of chemotherapy on the immune system can potentially make immunotherapy more          effective if administered soon after completion of chemotherapy. The addition of          recombinant human IL-7 (interleukin 7) (rhIL-7 (recombinant human interleukin 7)) may          make the immunotherapy more effective.      Objectives:      -To determine whether immune therapy given after immune suppression can help the body fight     the tumor and to determine the safety of the treatment.      Eligibility:      -Patients with solid tumors, i.e., Ewing's sarcoma, rhabdomyosarcoma or neuroblastoma whose     disease has recurred after treatment or spread beyond the original site      Design:        -  Patients undergo tumor biopsy (removal of a piece of tumor tissue) to collect tumor          cells for making a vaccine from proteins in the patient's tumor and apheresis (removal          of a quantity of white blood cells) to collect white cells for re-building the immune          system after immune therapy. Apheresis is repeated three times during immunotherapy          (weeks 8, 14 and 20).        -  After receiving standard chemotherapy for their tumor (and an additional course of          fludarabine and cyclophosphamide to further suppress immunity if needed) patients          receive immune therapy in Cohorts A and B. rhIL-7 is given 48 hours before the vaccine,          as an injection under the skin in an extremity that will not be used for the vaccine in          patients in Cohort B only. You will be watched closely for 6 hours after the rhIL-7 for          any signs of reaction. rhIL-7 will be given before vaccine doses #1, #2, #3, and #4. The          vaccine is given at study weeks 2, 4, 6, 8, 10 and 12. Each vaccine is given as a total          of six separate rhIL-7 followed by injections: three intradermal (like a (tuberculosis)          TB test) on one arm or leg and three subcutaneous (like those for insulin injections for          diabetes). on the other arm or leg. An anesthetic cream may be used to minimize the          discomfort of injections.        -  Patients' white cells are returned to them by infusion through a vein on the first day          of immune therapy.        -  Imaging studies and immune studies are done at weeks 1, 8 and 20 to determine the          response to treatment on the tumor and on the immune system.   "
234239|NCT00923364|"     Background:        -  Stem cells are immature blood cells that grow in the bone marrow and produce all of the          cells needed for normal blood and immunity. Stem cells can be taken from one person          (donor) and given to another person (recipient) through allogeneic stem cell          transplantation. Donor stem cells can then replace the recipient s stem cells in the          bone marrow, restoring normal blood production and immunity. Most allogeneic transplants          now use stem cells collected from the donor s blood in a process called peripheral blood          stem cell transplantation.        -  MonoMAC is an immunodeficiency disease that is characterized by a lack of monocytes, a          type of white blood cell, and an increased risk of developing mycobacteria infections          that may cause tuberculosis.        -  Allogeneic stem cell transplantation has been used successfully to treat many kinds of          immune diseases and cancers that develop in blood or immune system cells. Researchers          have been studying a particular kind of stem cell transplantation that uses lower than          usual doses of chemotherapy and particular combinations of drugs to improve the results          of the procedure for patients with blood-related cancers and pre-cancerous conditions.      Objectives:        -  To determine the safety and efficacy of reduced-intensity hematopoietic stem cell          transplants (a particular stem cell transplantation procedure) for treating MonoMAC.      Eligibility:        -  Patients 18 60 years of age who have MonoMAC and who have been matched with a suitable          stem cell donor.      Design:        -  Donors and recipients will undergo separate procedures as part of this protocol.        -  Donors:        -  National Institutes of Health researchers will take the donor s medical history, perform          a physical exam, take blood samples, and explain the procedure. Tests will be performed          to check the donor s heart, lung, kidney, and liver function.        -  Donors will receive injections of a drug called filgrastim (G-CSF), which causes stem          cells to travel from bone marrow into blood. The G-CSF shots will be given for 5 to 7          days before the collection procedure.        -  Donors will undergo apheresis to collect white blood cells and stem cells directly from          the blood, which can be done as an outpatient procedure. Researchers may consider the          alternative of directly collecting bone marrow from the donor, which will require an          overnight hospital stay.        -  Recipients:        -  Recipients will receive 3 days of pre-transplant chemotherapy and radiation therapy to          prepare for the transplant. For 4 days before the transplant, recipients will receive          the chemotherapy drug fludarabine, followed by a single dose of radiation therapy, and          will also receive the drugs tacrolimus and sirolimus to prevent the donor cells from          attacking the recipient s normal tissues.        -  Recipients will then receive the transplant of donor stem cells and will continue to          receive tacrolimus and sirolimus for 3 months after the transplant to prevent the donor          cells from attacking the recipient s normal tissues. Recipients will be discharged from          the hospital once their condition is stable.        -  Recipients will visit the NCI clinic regularly for the first 5 months after the          transplant, and then less often for at least 5 years. Recipients may receive additional          donor immune cells (donor lymphocyte infusion) after the transplant if the study doctors          believe they are needed.   "
234240|NCT00923377|"     Background:        -  Research suggests that breast cancers may arise from a population of stem cells in the          normal mammary gland that produce clones of cancer cells.        -  Researchers are now trying to determine what events may initiate the formation of cancer          cells.      Objectives:        -  To look for and describe breast stem cells from normal breast tissue from women who do          not have breast cancer.        -  To compare the breast stem cells between women at increased risk for breast cancer and          women at average risk for breast cancer.        -  To show a relationship between the number and type of breast stem cells with the density          (appearance) of the mammogram (breast x-ray).        -  To make cell cultures (grow cells under controlled conditions) from the breast stem          cells.      Eligibility:      -Women 18 years of age and older who are at average or increased risk for breast cancer.      Design:      Participants complete a health history questionnaire, family history questionnaire and risk     assessment questionnaire.        -  Participants have a mammogram and breast biopsy (surgical removal of a sample of breast          tissue).        -  Women who can become pregnant have a urine pregnancy test....   "
234241|NCT00923390|"     Background:        -  An experimental cancer treatment procedure involves taking a patient s own tumor or          blood cells, modifying them with a gene that targets proteins on the surface of tumor          cells, and growing those cells in a laboratory. The modified cells are then given back          to the patient by intravenous (IV) transfusion, in the hope that the new cells will          attack and destroy the cancer cells without harming healthy tissue.        -  This procedure has been used for melanoma patients, and researchers are now attempting          to use this treatment for patients with renal (kidney) cancer. In the laboratory, this          attack kills nearly all kidney cancers tested, but not normal tissues. However, the          effectiveness and possible side effects of this treatment are still being studied.      Objectives:        -  To find out if cells modified to target DR4 and TRAIL (two proteins found on the surface          of many kidney tumors) are effective in treating kidney cancer.        -  To determine the maximum tolerated dose (the highest dose that does not cause          unacceptable side effects) of the modified cells.      Eligibility:        -  Patients 18 years of age and older with metastatic renal cancer whose disease has not          responded to standard treatment.        -  Patients will be divided into two study branches: Arm A for those who will be receiving          modified cells from their biopsied tumor, and Arm B for those who will be receiving          their own modified white blood cells.      Design:        -  Five-stage treatment process, outpatient for stages 1 and 5 and inpatient for stages 2          through 4:        -  Work-up (1 to 2 weeks): Physical examination, heart and lung function tests, imaging          tests, blood and/or tumor samples taken.        -  IV chemotherapy (1 week): Cyclophosphamide and fludarabine to prepare for the new cell          infusion.        -  IV cell infusion and treatment with IL-2 to support the modified cells (4 days).        -  Recovery (1 to 2 weeks): Recover from effects of chemotherapy and infusion.        -  Follow-up (every 1 to 6 months): Return to clinic for physical exam, review of side          effects, other tests.        -  Follow-up evaluations will continue to determine the success of the treatment.        -  Evaluations during the treatment period:        -  Physical examination, including vital signs and body weight checks, and pregnancy test          for women who can become pregnant.        -  Blood and urine tests.        -  Disease evaluation and monitoring on both inpatient and outpatient basis.        -  Because researchers do not know the long-term side effects of gene therapy, patients          will be asked to participate in long-term follow up for up to 15 years. The follow-up          will involve yearly physical exams and medical history, and blood collection (3, 6 and          12 months after treatment, and every year after that).   "
234242|NCT00923403|"     Hypercholesterolemia is a well-established risk factor for the development of     atherosclerosis, a component of cardiovascular disease (CVD). The National Cholesterol     Education Program advises the public to consume 2 g/day of plant sterols or stanols in     addition to the Therapeutic Lifestyle Change Diet to lower elevated low-density lipoprotein     (LDL) cholesterol levels. For foods to carry the FDA health claim label they must contain     0.65 g of phytosterol ester or 1.7 g of phytostanol ester per serving. The study was a     controlled diet, cross-over clinical investigation using a Latin square sequence. It     consisted of two 29 d phases separated by a four week wash out interval. Subjects were     randomized to one of two treatment arms: 1 % dairy milk or low-fat soy beverage providing     1.95 g plant sterols/day.   "
234507|NCT00917176|"     The aim of this study is to investigate whether greater occipital nerve stimulation is     effective in the treatment of fibromyalgia related pain. The study uses sub sensory threshold     stimulation and placebo stimulation in order to investigate whether sub-threshold stimulation     is feasible in a placebo controlled study.   "
234245|NCT00923442|"     This study will collect tumor samples from people with cancers of the blood, bone marrow, or     lymph glands for laboratory study of the biology of these conditions. Such studies contribute     to a better understanding of cancer biology and to the development of new treatments. Planned     studies include:        -  Examination of individual cancer cells and to search for differences compared to other          types of cancer and normal cells        -  Examination of the chromosomes and genes in cancer cells and to search for differences          compared to other types of cancer and normal cells        -  Development of sensitive methods to detect small amounts of cancer that remain after          treatment        -  Search for new cancer proteins that might serve as targets for treatment        -  Investigation of methods to develop cancer vaccines.      Patients from birth to 75 years of age with acute lymphocytic leukemia, acute myelogenous     leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, juvenile myelomonocytic     leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, and other hematologic malignancies may     be eligible for this study.      Blood or bone marrow samples will be collected when sampling is required for the patient's     medical care. Cells from some individuals will be grown in test tubes, establishing cell     lines or in animals, establishing xenograft models. (A xenograft is transplantation of cells     of one species to another species.)   "
234246|NCT00923468|"     Background:        -  A pharmacokinetic (PK) study of a new drug involves taking several blood samples over a          period of time from study participants to determine how the body handles the substance.          These studies provide critical information about new drugs.        -  Often, patients or parents of children in drug studies choose not to participate in          optional PK studies that are part of the study protocol.        -  A better understanding of why patients or families do or do not agree to participate in          PK studies may help researchers make it easier for people to participate in them.      Objectives:        -  To learn why some people do or do not agree to participate in PK blood sampling studies.      Eligibility:        -  Patients 18 years of age and older and parents or guardians of children who are          participating in a study of a drug that includes the option of participating in PK          sampling.      Design:        -  Participants fill out a 2-page survey asking about why they did or did not participate          in the study's PK sampling.   "
234247|NCT00923481|"     Background:        -  The drug R935788 (fostamatanib disodium) is a kinase inhibitor (i.e., it interferes with          cell communication and growth and may prevent tumor growth).        -  R935788 has shown promising activity in NCI-60 (a panel of 60 diverse human cancer cell          lines) against colon cancer, non-small cell lung cancer, and renal cell carcinoma cell          lines, as well as in two renal cell xenograft models.        -  This is an open-label, Phase II study of R935788. Phase I studies in patients with          immune thrombocytopenic purpura, rheumatoid arthritis, and lymphoma have demonstrated          safety with a continuous dosing schedule, and a maximum tolerated dose has been          established.      Objectives:        -  To test an experimental drug called R935788 (fostamatinib disodium) for its ability to          stop cancer growth signals, thus slowing the growth of cancer cells in laboratory          testing.        -  To determine the clinical response of R935788 administered orally twice a day on a          continuous schedule in patients with colorectal carcinoma, pheochromocytoma, follicular          or papillary thyroid cancer, non-small cell lung cancer, hepatocellular, carcinoma of          the head and neck, and renal cell carcinoma.        -  To evaluate the effects, safety, and biochemical response of R935788 therapy.      Eligibility:        -  Patients with colorectal carcinoma, pheochromocytoma, follicular or papillary thyroid          cancer, non-small cell lung cancer (excluding squamous cell histology), hepatocellular          cancer, carcinoma of the head and neck, and renal cell carcinoma whose disease has          progressed after any therapy or who have no acceptable standard treatment options.        -  Patients must have recovered from toxicities of prior therapies to at least eligibility          levels.        -  Patients who have received radiation or chemotherapy within 4 weeks of study enrollment          are not eligible.        -  Women who are pregnant or breastfeeding are not eligible.      Design:        -  Researchers will conduct the following tests and procedures during the study:             -  Clinic visits with a physical exam, including vital signs and blood pressure, every               other week during cycle 1, and once a month starting with cycle 2.             -  Blood will be drawn weekly during cycle 1, every other week during cycle 2, and               once a month starting with cycle 3; urine tests will be conducted depending on               results of blood tests.             -  Imaging tests, such as computed tomography (CT) scans (a series of x-rays) or               ultrasound (an examination using sound waves), will be done every 8 weeks while the               patient is receiving R935788.        -  R935788 will be administered orally twice a day for 28 days (one cycle). Imaging studies          will be obtained every two cycles. Patients will fill in a diary to show when they took          the medication and to note any side effects. The 28-day treatment cycle will be repeated          as long as the patient is tolerating R935788 and the cancer is either stable or getting          better.        -  Researchers will conduct the following additional tests to see how the study is          affecting the patient:             -  Other research blood samples will be collected before treatment, at cycle 1 week 3,               at the beginning of cycle 2, and at 8 weeks.             -  Optional tumor biopsies will be requested before starting treatment, at cycle 1 day               28.             -  Patients with specific lesions or tumors may be asked for an optional tumor biopsy               on day 8.   "
234248|NCT00923494|"     This research study is being done in order to find out if there is any difference in the     effectiveness of ultrasound guided supraclavicular brachial plexus nerve block that can be     achieved with 3 different amounts of ropivacaine 0.5% (20 ml, 30 ml, and 40 ml). The     investigators want to show if you can have a successful nerve block with less amount of local     anesthetic, thus potentially decreasing the risk of side effects.   "
234249|NCT00923507|"     Background:      The development of new technologies now allow scientists to investigate the molecular basis     and clinical manifestations of monoclonal B cell lymphocytosis (MBL), chronic lymphocytic     leukemia(CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom     macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL). Applying these methods in     a natural history study can clarify processes involved in disease progression and possibly     lead to the discovery or validation of treatment targets.        -  Objectives:             -  Study the biology and natural history of MBL/CLL/SLL in patients prior to the time               when their disease requires treatment and the biology of LPL/WM and SMZL.             -  Characterize clinical, biologic and molecular events of disease stability and               progression of patients enrolled on this protocol.        -  Eligibility:             -  Diagnosis of MBL/CLL/SLL/LPL/WM/SMZL             -  Age greater than or equal to 18 years.             -  Patients with CLL/SLL must not have received previous cytotoxic, monoclonal               antibody, or kinase inhibitor therapy.             -  Patients with LPL/WM or SMZL can have prior therapy.             -  ECOG performance status of 0-2.        -  Design:             -  Patients are typically followed every 6 to 24 months in the clinic and have blood               drawn. When required patients may undergo additional testing that may include bone               marrow biopsy and aspiration, blood drawing, lymph node biopsy, x-ray studies,               positron emission tomography and CT and MRI scans. Some of these tests may be               required to monitor CLL/SLL, LPL/WM, and SMZL patients. Other tests, such as bone               marrow biopsy and aspiration, lymph node biopsy, may not be clinically indicated,               but patients may be asked to undergo these procedures for research purposes)             -  Clinical information is collected and stored in a central databank.             -  Patients whose cancer requires treatment will be taken off the study and treatment               options will be discussed with them. If no NIH treatment protocols are available to               them, they will be returned to the care of their local physician.   "
234250|NCT00923520|"     Background:        -  Dimethane sulfonate (DMS612) is an investigational drug that is being administered to          humans for the first time in people with advanced tumors. More information on the          maximum tolerated dose of DMS612 will help researchers identify whether the drug is          suitable for use in treating certain kinds of cancer, particularly renal cell carcinoma.      Objectives:        -  To determine the maximum tolerated dose of DMS612 (the highest dose that does not cause          unacceptable side effects) and evaluate any side effects.        -  To see if DMS612 has any effect on patients tumors through blood tests and laboratory          studies.        -  To learn how the body processes DMS612.      Eligibility:        -  Patients 18 years of age and older who have been diagnosed with cancer that has not          responded well to standard treatments.      Design:        -  Pre-treatment evaluation visit to determine eligibility:        -  Physical examination        -  Blood and urine tests        -  Chest X-ray; electrocardiogram; CAT scan of chest, abdomen, pelvis, and other areas of          the body if needed        -  Other possible tests, such as magnetic resonance imaging (MRI) or positron emission          tomography (PET)        -  Patients will receive one dose of DMS612 by intravenous infusion once a week for 3          weeks, followed by 1 week without the drug. Doses will be adjusted based on possible          side effects and cancer response. The disease will be evaluated after three cycles of          the drug.        -  Evaluations during the treatment period:        -  Physical examination and reviews of side effects.        -  Blood draws to evaluate the effectiveness of the drug, and how it is processed by the          body.        -  CAT scan at the end of every two cycles (every 8 weeks).        -  Other scans and imaging procedures as required by the study doctors.   "
234251|NCT00923533|"     To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.   "
234252|NCT00923559|"     Mother-infant relationship disturbances broadly comprise three areas; maternal distress,     infant functional problems, and relationship difficulties. Given the high frequency of such     disturbances and the relative paucity of randomized treatment studies, substantial systematic     investigation is needed. This project is a randomized controlled study comparing     mother-infant psychoanalytic treatment with treatment as usual in cases where mothers and/or     health visitors demanded expert help.   "
234253|NCT00923572|"     The objective of this Post Marketing Surveillance (PMS) is to gain information about safety     and efficacy in real practice.   "
234281|NCT00923988|"     Passive smoking is associated with an increased risk for cardiovascular events. However, the     exact mechanisms by which passive smoking affects cardiovascular health are not entirely     understood. In the present study, the researchers investigate the effects of short-term     exposure to secondhand smoke on platelet function and peripheral microvascular endothelial     function in healthy individuals. For this purpose, platelet function and endothelial function     are measured before and after a 1-hour exposure to secondhand smoke in a concentration that     is encountered in bars and restaurants without smoke-free policies. The researchers'     hypothesis is that short-term exposure leads to platelet activation and impairment of     endothelial function.   "
234254|NCT00923598|"     This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing     bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one     of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The     contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%.     The basal rate and patient-controlled bolus volume will depend upon the treatment group, but     the total dose of local anesthetic is the same for each. For the duration of the study, all     patients will receive the current usual and customary analgesics for bilateral TKA patients.     All patients will receive a ropivacaine perineural infusions initiated in the operating room     and continued until at least the afternoon of postoperative day (POD) 2, as well as oral     acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of     administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with     0 equal to no pain and 10 being the worst imaginable pain.   "
234255|NCT00923611|"     The purpose of this study is to evaluate the antihypertensive efficacy and tolerability of 8     week treatment with Fimasartan (BR-A-657-K) 20, 60, 120, 240 mg and placebo in patients with     mild to moderate essential hypertension and to determine the adequate antihypertensive dosage     for later clinical study.   "
234256|NCT00923624|"     The purpose of this study is to conduct a randomized control trial of a behavioral     intervention delivered by nurses via an electronic medical record (EMR) patient web portal to     determine if this is an efficacious method for supporting medication adherence.   "
234257|NCT00923637|"     The main purpose of this phase II trial is to evaluate the clinical feasibility-in terms of     patients without dose limiting toxicities or premature treatment withdrawal or death-of     administering adjuvant chemotherapy of pemetrexed followed by pemetrexed/oxaliplatin     immediately post-video-assisted thoracic surgery (VATS) in patients with completely resected     Non-Small Cell Lung Cancer (NSCLC).   "
234258|NCT00923650|"     Background:        -  Informed consent is the process by which prospective participants in clinical trials          learn about clinical research in order to decide whether they want to enroll in the          study. It consists of meetings and discussions with the health care team.        -  Phase I clinical trials are designed to determine what dose of an investigational agent          is safe to administer to patients.      Objectives:        -  To study communication, comprehension and decision-making during the informed consent          process.        -  To examine ethical, psychological, social, and educational issues regarding informed          consent.        -  To help researchers understand how to improve informed consent and education about          clinical research.      Eligibility:        -  Parents or guardians of children with cancer who are being considered for participation          in phase I clinical trials        -  Prospective patients for pediatric phase I clinical trials who are between 14 and 21          years of age.        -  Members of the research team who obtain consent from patients and families for pediatric          phase I clinical trials      Design:        -  Research assistants observe and record the informed consent conference held with the          research team and the parents and children.        -  After the conference, the research assistant interviews the parents in a private area          about their experience during the conference and their decision-making process. They are          asked about their thoughts and opinions during the informed consent conference,          including the decision-making process, communication and trust in the medical team.        -  With their parent's permission, patients are interviewed privately to discuss their          experience during the informed consent conference.        -  After parents and patients have made their decision about participation in the study,          they are interviewed again about how they made the decision, aspects of the          communication during the conference, and how they feel about the doctor. This interview          is also recorded.        -  Parents may be contacted 6 months to 2 years from the time of their participation to be          part of a parent advisory group about the informed consent process.   "
234259|NCT00923663|"     The activity of monotherapy with Lenalidomide will be evaluated in patients with lymphoma of     the mucosa associated lymphoid tissue (MALT).   "
234260|NCT00923676|"     Hyperlipidemias are frequently associated with and are considered an important cause of     erectile dysfunction in men. This association has been attributed to the impairment of blood     flow through endothelium-dependent relaxation in smooth muscle cells of corpus cavernosum.     Basic science and human research suggest that the vascular pathophysiology of male and female     sexual dysfunction may be similar, as the first phase of the female sexual response is     mediated by a combination of vasocongestive and neuro-muscular event which include increased     clitoral length and diameter, as well as increased vaginal lubrication, wall engorgement and     luminal diameter. The investigators have shown that women with hyperlipidemia had a higher     prevalence of sexual dysfunction as compared with age-matched women without hyperlipidemia.      The aim of this study was to asses the effect of anti-hyperlipidemic drugs (fenofibrate and     rosuvastatin, single or in combination) on validated indices of sexual function in     hyperlipidemic men and women with sexual dysfunction at baseline.   "
234261|NCT00923702|"     The primary study hypothesis is that a two-dose human papillomavirus (HPV) vaccine regimen     would offer similar immunogenicity and protection as that of a three-dose regimen to girls     against persistent HPV infection and cervical neoplasia caused by HPV types included in the     vaccine.   "
234262|NCT00923715|"     The purpose of this study is to determine whether exenatide and pramlintide will improve     blood glucose control after meals when compared to insulin alone.   "
234263|NCT00923728|"     Background:        -  AVN944 is an experimental cancer treatment drug, not yet approved by the U.S. Food and          Drug Administration. To date, AVN944 as a single drug has been tested in several studies          involving humans, including healthy volunteers, patients with leukemia, and patients          with advanced pancreatic cancer.        -  More research is needed to determine the safety and effectiveness of AVN944.      Objectives:        -  To determine the safety of AVN944.        -  To determine the maximum tolerated dose (the highest dose that does not cause          unacceptable side effects) of AVN944.        -  To see if AVN944 has any effect on patients' tumors.        -  To learn how the body breaks down AVN944.      Eligibility:        -  Patients 18 years of age and older who have advanced stage solid tumors for which          standard therapies do not exist or are no longer effective.      Design:        -  Participants will have a screening visit and five clinic visits during the first          treatment cycle. Additional treatment cycles will involve two clinic visits during each          28-day cycle. After participation in the study ends, patients will be asked to return          within 28 days after the last dose of study drug for final study procedures.        -  Evaluations before the treatment period:        -  Physical examination, including vital signs and body weight checks, and pregnancy test          for women who can become pregnant.        -  Questions about medications and side effects.        -  Blood and urine tests.        -  Disease evaluation with CT, chest x-ray, and additional laboratory tests depending on          the type of cancer.        -  All patients will have blood samples taken at each visit.        -  Patients will take specific doses of AVN994 as directed by researchers, and will be          asked to keep a diary to record their doses and any side effects. They will be monitored          with frequent blood draws at each study visit to provide information on the safety and          effectiveness of the drug.        -  During different cycles, patients will have their disease evaluated by researchers and          will be asked if they wish to continue taking AVN994 as part of the study.   "
234317|NCT00924495|"     The purpose of this study is to explore the cortical regulation of the paraspinal muscles in     chronic low back pain. These (possible) changes in regulatory mechanisms are being compared     to other motor control tests in order to determine whether correlations are found.     Furthermore the patients are being treated with repetitive transcranial magnetic stimulation     (rTMS) and tested afterwards. The purpose is to find out if rTMS-therapy is capable of     normalizing motor control deficits.   "
234318|NCT00924508|"     The primary objective of this clinical study is to determine whether occlusion of     triamcinolone 0.1% cream (TAC) with hydrogel patch improves its efficacy in treating eczema.     A secondary objective is to determine whether eczema improves under occlusion with hydrogel     patch alone, without TAC.   "
234264|NCT00923741|"     Background:      More effective therapies are needed for patients with non-small cell lung cancer (NSCLC)     whose disease has advanced or spread beyond the original site following standard treatment.      Talactoferrin is a genetically engineered form of the human protein lactoferrin, found in     body secretions such as breast milk, tears and saliva.      In previous studies, talactoferrin improved life span in patients with NSCLC without causing     toxic side effects.      Objectives:      To examine the effects of talactoferrin on the immune system and determine its effectiveness     in treating NSCLC.      Eligibility:      Patients with advanced NSCLC who have tissue type HLA-A2 and whose cancer has gotten worse     following at least one course of treatment.      Design:      Talactoferrin treatment: Patients take liquid talactoferrin twice a day for 12 weeks,     followed by 2 weeks off the drug. Treatment may continue in these 14-week cycles depending on     the drug side effects and the response of the tumor.      Evaluations: Patients are evaluated at the clinic with a physical examination, check of vital     signs and blood tests every 3 weeks.      CT scans: Patients have CT scans to monitor disease before starting treatment, again at 6     weeks and 12 weeks and then every 12 weeks during the duration of treatment.      Apheresis: Quantities of white blood cells called lymphocytes are collected through a     procedure called apheresis in order to measure the immune response to treatment. In this     procedure, blood is collected through a needle placed in a vein in the arm (similar to     donating blood) and circulated through a cell separator machine. The lymphocytes are     extracted and the rest of the blood is returned to the body through the same needle.   "
234265|NCT00923780|"     Background:        -  Tumors depend on blood vessels to provide the nourishment that allows them to grow.        -  Thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among the          tumors that contain the most blood vessels. Thus, endocrine tumors are important for the          study of new blood vessel formation in tumors.      Objectives:      -To obtain tissues from endocrine tumors for examination to determine how they differ from     normal tissue.      Eligibility:      -Patients who are scheduled for surgery to remove an endocrine tumor, those in or around the     thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue.      Design:        -  Tissues will be obtained from patients during surgery to remove thyroid, parathyroid,          adrenal, pancreas, or neuroendocrine tumors.        -  About 400 patients will be enrolled in the study over a period of 5 years.   "
234266|NCT00923793|"     The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer     aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to     infections, re-operations, antibiotic treatment or removal of the implant.   "
234267|NCT00923806|"     Background:        -  Carcinoembryonic antigen (CEA) is a protein present mostly in cancer cells.        -  An experimental procedure developed for treating patients with cancer uses blood cells          found in their tumors or bloodstream. These cells are genetically modified using the          anti-CEA gene and a type of virus. The modified cells (anti-CEA cells) are grown in the          laboratory and then given back to the patient to try to decrease the size of the tumors.          This is called gene therapy.      Objectives:        -  To determine whether advanced cancers that that express the CEA antigen can be treated          effectively with lymphocytes (white blood cells) that have been genetically engineered          to contain an anti-CEA protein.      Eligibility:        -  Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond          the original site) and for whom standard treatments are not effective.        -  Patients' tumors express the CEA antigen.        -  Patients have the human leukocyte (HLA-A*0201) antigen.      Design:        -  Workup with scans, x-rays and other tests.        -  Leukapheresis to obtain cells for preparing the anti-CEA cells for later infusion.        -  1 week of chemotherapy to prepare the immune system for receiving the anti-CEA cells.        -  Infusion of anti-CEA cells, followed by interleukin-2 (IL-2) treatment. The cells are          given as an infusion through a vein. IL-2 is given as a 15-minute infusion through a          vein every 8 hours for a maximum of 15 doses.        -  1-2 weeks of recovery from the effects of chemotherapy and IL-2.        -  Periodic follow-up clinic visits after hospital discharge for physical examination,          review of treatment side effects, laboratory tests and scans every 1 to 6 months.   "
234268|NCT00923819|"     The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity     is to determine whether surgical treatment gives more health benefits than standard     conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a     low complication rate.   "
234269|NCT00923832|"     Background:        -  Fungal infections of the lung (pneumonia) can be caused by molds, such as Aspergillus          and Zygomycetes, but these causes are often difficult for a doctor to diagnose. Early          and accurate diagnosis of these infections can help doctors to select the correct          medicines for proper treatment.        -  A number of methods are used to diagnose fungal pneumonia. Ones that are commonly used          in clinical practice include radiographic imaging (chest X-rays and computed tomography          (CT) scans), blood tests, and cultures taken from fluid from the lungs (broncho-alveolar          lavage (BAL) fluid). Other new methods may improve the diagnosis of fungal pneumonias.          These methods include tests that can detect DNA from the fungal germ in blood and BAL          fluid of some patients with these infections.      Objectives:        -  To help develop better and more accurate methods of diagnosing fungal lung infections.        -  To detect fungal DNA and chemicals in the bloodstream and BAL fluid of immunocompromised          patients with pneumonia.      Eligibility:      - Immunocompromised patients who are currently enrolled in another NIH protocol and who have     a CT scan that shows a possible fungal infection of the lung.      Design:        -  Researchers will review patients' existing medical records and CT scans, and current          pneumonia treatment plans.        -  Patients will provide blood and BAL samples for the duration of their treatment for          pneumonia, as required by researchers. Additional CT scans will not be performed, except          as part of existing treatment plans.   "
234334|NCT00924729|"     This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5%     ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after     pre-operative topical administration in subjects undergoing cataract surgery.   "
234335|NCT00924742|"     The purpose of this study is to examine the pharmacokinetic properties of Tapimycin injection     (piperacillin 4 g + tazobactam 0.5 g powder for injection) in healthy volunteers under     fasting conditions.   "
234270|NCT00923845|"     Background:      Low-dose chemotherapy is easier for the body to tolerate than typical high-dose chemotherapy     and involves a shorter period of complete immune suppression.      Donor immune cells called lymphocytes, or T cells, fight residual tumor cells that might have     remained in the recipients body after stem cell transplant, in what is called a     graft-versus-tumor (GVT) effect.      The immune-suppressing drug sirolimus appears to help prevent graft-versus-host disease     (GVHD), a side effect of stem cell transplant in which donated T cells sometimes attack     healthy tissues, damaging organs such as the liver, intestines and skin.      Th2 cells are cells collected from the transplant donor and grown in a high concentration of     sirolimus.      Objectives:      To determine whether stem cell transplantation using low-dose chemotherapy and     sirolimus-generated Th2 cells can cause a remission of advanced kidney cancer.      Eligibility:      Patients between 18 and 75 years of age who have kidney cancer that has spread beyond the     kidney and who have a tissue-matched sibling stem cell donor.      Design:      Patients undergo stem cell transplantation as follows:        -  Low-intensity chemotherapy with pentostatin and cyclophosphamide over a 21-day period to          reduce the level of the immune system to prepare for the transplant. Pentostatin is          given through a vein (intravenous (IV)) on days 1, 8 and 15; cyclophosphamide tablets          are taken by mouth for 21 consecutive days.        -  Sirolimus tablets, taken by mouth, starting 2 days before the transplant and continuing          until 60 days after the transplant.        -  IV infusions of stem cells and Th2 cells.      Following the transplant, patients have the following procedures:        -  Additional Th2 cell infusions on days 14 and 45 after the transplant.        -  Follow-up visits at the National Institutes of Health (NIH) Clinical Center twice a week          for the first 6 months after the transplant and then less frequently for at least 5          years to evaluate response to treatment and treatment side effects. Evaluations include          a bone marrow aspirate and biopsy 1 month after transplant and periodic blood tests and          imaging procedures (e.g., computed tomography (CT) or magnetic resonance imaging (MRI)          scans).   "
234271|NCT00923858|"     The purpose of this project is to provide information which can help us understand what     happens over time to rotator cuff tears. In this study, the investigators will follow a     population of people with rotator cuff tears that do not hurt (asymptomatic) and to establish     the probability that an asymptomatic rotator cuff tear, identified in the context of     contralateral symptoms, will become symptomatic over time. To determine with ultrasound the     probability that a rotator cuff tear will enlarge over time. To determine if symptom     progression correlates with enlargement of the rotator cuff tear and/or degenerative changes     on radiographs. In order to obtain data, study subjects will be recalled for follow-up at 1     year time points over a 5 year period. The study subjects will have repeat physical exam,     ultrasound and radiographic examinations. A control group of normal patients will also be     followed for comparison.   "
234272|NCT00923871|"     Breast radiation treatment is planned from a Computed Tomography (CT) scan. This study is     designed to investigate a method to reduce the time between the planning of radiation     treatment and its actual start by automating the intensity-modulated radiation therapy (IMRT)     planning process. The investigators plan to examine data from another scan called Cone Beam     Computed Tomography (CBCT). A CBCT scan provides similar information to a conventional CT     scan, however the images for CBCT are acquired at the treatment unit (linear accelerator used     for treatment). Using these x-ray pictures of patients, the study team consisting of a     radiation oncologist, a medical physicist and a radiation therapist will create a custom     treatment plan unique to each patient. By doing this, the investigators hope to reduce the     amount of time spent waiting for treatment and the number of hospital visits for patients in     the future.   "
234273|NCT00923884|"     Background:        -  The Lung Cancer section of the National Cancer Institute s Medical Oncology Branch is          running a study to better understand which genes might be important in patients who are          undergoing therapy for lung cancer.      Objectives:        -  To find out if differences (also called polymorphisms) in specific genes lead to          differences in outcomes (such as treatment success and survival rates) for patients who          have been diagnosed with lung cancer.        -  To establish a repository of genetic information for future studies of these differences          and their relation to lung cancer.      Eligibility:        -  Any individual who has been diagnosed with lung cancer and is being treated through the          National Cancer Institute.      Design:        -  After entrance in this study, patients will provide information to the researchers on          age, gender, race/ethnicity, treatments received and response to treatments, and other          specific information about their disease. This information will be kept confidential.        -  Approximately half a tablespoon of blood will be drawn.        -  Patients will be treated for lung cancer with normal treatment methods, as if they had          not been enrolled in the study        -  Some patients may be offered the option of enrolling in separate research protocols for          cancer treatment, involving chemotherapy, surgery, or radiation.   "
234274|NCT00923897|"     Palliative radiotherapy is radiation treatment given to help reduce pain or discomfort, or     other symptoms related to cancer. This is used commonly for cancer that has spread to the     bones and brain, and for many other primary cancers that are too advanced to be cured,     including lung cancer, pancreatic cancer and head and neck cancer. The benefits of palliative     radiotherapy for advanced liver cancer have not been well studied.      This study is designed to help to see whether palliative radiation therapy is effective in     controlling pain, discomfort or other symptoms related to liver cancer, and how this therapy     Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and     Hepatic Metastases might affect the quality of life of patients receiving such therapy. This     information will help the doctors understand if there are specific conditions under which     radiation therapy is more effective and worthwhile, and how it may affect the quality of life     for patients who have locally advanced hepatocellular carcinoma and hepatic metastasis.   "
234275|NCT00923910|"     Background:        -  Most patients with acute lymphoblastic leukemia (ALL) and many patients with acute          myelogenous leukemia (AML), chronic myelogenous leukemia (CML) and non-Hodgkin's          lymphoma (NHL) have a protein called Wilm's Tumor 1 (WT1) in their cancer cells. This          protein is thought to be able to influence the growth of these cancers.        -  A vaccine made with the WT1 protein may boost the immune system to help fight these          cancers in patients whose cancer cells contain the protein.      Objectives:        -  To determine the safety, effectiveness and side effects of giving the WT1 vaccine and          donor white blood cells to patients with AML, ALL, CML or NHL who have previously          received standard treatment and undergone stem cell transplantation.        -  To determine the immune response to the WT1 vaccine and donor white blood cells in these          patients and to determine if the response is related to the amount of WT1 protein in the          patient's cancer cells.      Eligibility:        -  Patients between 1 and 75 years of age with the blood antigen human leukocyte antigen          (HLA-A2) and the WT1 cancer protein who have persistent or recurrent blood cancers after          stem cell transplantation.        -  The prior stem cell transplant donor must be willing to provide additional cells, which          will be used to prepare the cellular vaccines and for donor lymphocyte (white blood          cell) infusions.      Design:        -  Patients are given the WT1 vaccine every 2 weeks for 6 weeks (weeks 0, 2, 4, 6, 8, 10).          Each vaccination consists of two injections in the upper arm or thigh.        -  On weeks 0, 4 and 8, patients also receive white blood cells from a donor to enhance the          immune response. The cells are also given as a 15- to 30-minute infusion through a vein          about 1 hour after the vaccine injection. Donor infusions are given only to patients          with mild or no graft-vs-host disease resulting from their prior stem cell          transplantation.        -  Periodic physical examinations, blood and urine tests, scans to evaluate disease and          other tests as needed are done for 12 months after enrollment in the study.   "
234508|NCT00917189|"     This study will test a computer-based treatment for youth with the genetic disorder     velocardiofacial syndrome (VCFS) to help them improve skills in memory, attention, and     executive functioning.   "
234276|NCT00923923|"     Method: This study is designed as an accompaniment to an already funded study - a 12-week     treatment trial with prazosin for patients with PTSD and AD.      The study design will consist of III phases. In phase I, all subjects will participate in     three laboratory sessions to determine their reactivity to stress. Stress reactivity will be     measured using: traumatic experiences, stressful non-trauma experiences and neutral     experiences, presented randomly. Laboratory sessions will be conducted in an outpatient     setting. Phase II is a randomized clinical trial evaluating prazosin versus placebo for 12     weeks in a double-blind, controlled fashion in an outpatient setting. The treatment will last     for 12 weeks and outcomes will include symptoms of PTSD and alcohol use. In phase III,     subjects will again participate in a laboratory session. This phase of the study will be     conducted after at least 6 weeks of treatment while patients are on medication (prazosin or     placebo).      Hypotheses:      Primary: The investigators hypothesize that prazosin will be more effective than placebo in     reducing trauma-related stress reactivity in a laboratory paradigm, particularly anxiety,     craving for alcohol, and hormonal response, in individuals with PTSD and AD.      Secondary: The investigators hypothesize that stress reactivity will have a moderating effect     on treatment with prazosin, such that individuals with high levels of stress reactivity will     have fewer heavy drinking days, a significant reduction in PTSD symptoms, and shorter time to     relapse than individuals with low levels of stress reactivity.   "
234277|NCT00923936|"     Background:        -  The drug liposomal doxorubicin is approved by the U.S. Food and Drug Administration          (FDA) for the treatment of Kaposi's sarcoma (KS). A second drug, bevacizumab, is a          biologic agent (such as antibodies, interleukins, and vaccines) that stops abnormal          blood supply to tumors. Bevacizumab is approved by the FDA, in combination with other          drugs, for the treatment of breast cancer, colon cancer, and lung cancer.        -  Researchers are now studying the combination of liposomal doxorubicin with bevacizumab          as a novel approach to the treatment of advanced KS. Researches will be measuring KS          tumor responses to this combination to determine whether the drugs might have anti-KS          activity.      Objectives:        -  To estimate the overall response rate (ORR) of six cycles of liposomal doxorubicin          combined with bevacizumab in patients with advanced KS.        -  To evaluate the safety of the regimen and to estimate the complete response rate after          six cycles, the median number of cycles needed to obtain a partial response, and the          12-month progression-free survival.      Eligibility:        -  Patients 18 years or older with relatively severe acquired immune deficiency syndrome          (AIDS)-related KS or patients with KS unrelated to AIDS or human immunodeficiency virus          (HIV) infection, whose KS that can be evaluated for potential response to therapy and          meet a number of other criteria.        -  Women who are pregnant or breastfeeding are not eligible.        -  Other ineligibility criteria include surgery within 4 weeks, chemotherapy within 3          weeks, heart disease, hemoptysis (coughing up blood), or gastrointestinal bleeding.      Design:        -  Researchers will conduct the following tests before the start of the study:        -  Physical examination and a detailed medical history.        -  A biopsy.        -  Blood and urine tests.        -  Treatment will include two phases, an induction phase and a maintenance phase:        -  Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later          by liposomal doxorubicin mg/m2 and bevacizumab every 3 weeks for six cycles.      Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.        -  Monitoring will include a review of side effects, physical exam (including blood          pressure), and blood and urine samples; following the induction phase, the patient will          receive a multi gated acquisition scan and electrocardiography (EKG) to record          electrical activity in the heart.        -  Research tests include blood and saliva samples, additional biopsies (optional), and          noninvasive imaging.        -  Treatment is stopped if any of the following occur: completion of 1 year of therapy,          progressive KS, patient preference, or unacceptable toxicity.        -  Post-treatment evaluations include clinic visits every 3 months or as needed up to 2          years, and blood and saliva samples (for research).   "
234278|NCT00923949|"     Background:        -  Pioglitazone is a drug that belongs to the class of antidiabetic agents called          thiazolidinediones. It is approved for treatment of type 2 diabetes mellitus.        -  Research suggests that the thiazolidinediones may have anticancer activity that can          reduce cancer risk or cause tumors to shrink.      Objectives:      -To test how a pioglitazone works as a treatment of Stage IA to IIB Non-Small Cell Lung     Cancer (NSCLC) and to look at the effect of the drug on cancer cells.      Eligibility:      -Patients 18 years of age or older who will undergo surgery for Stage IA to IIB non-small     cell lung cancer (NSCLC).      Design:      -The study includes a screening visit to determine eligibility, treatment with pioglitazone,     a follow-up visit after 2 to 3 weeks of treatment and a post-surgery visit. Procedures     include:        1. Medical history, physical examination, blood tests, electrocardiogram        2. Bronchoscopy to obtain cancer cells. This is done before pioglitazone treatment begins          and again during lung surgery. Some patients may also require mediastinoscopy or biopsy          to collect cells.        3. Treatment with pioglitazone tablets once a day for at least 2 weeks and no more than 6          weeks, depending on when surgery has been scheduled.        4. Positron emission tomography (PET) scan before starting pioglitazone treatment. National          Cancer Institute (NCI) patients also have a follow-up PET scan after treatment but          before surgery.   "
234279|NCT00923962|"     GLP-1 is an incretin hormone which is discharged from the intestines after food intake. The     hormone is known for its powerful insulinotropic and trophic effects on the beta cells in the     pancreas and is currently used as an anti-diabetic agent in patients with type 2 diabetes     (T2DM).      GLP-1 receptors are widely distributed including on the endothelial cells in both coronary     and skeletal muscle circulation and on the myocardium. GLP-1-receptor studies on knock-out     mice have shown that they exhibit a reduced myocardial contractility and reduced diastolic     heart function. GLP-1 also shows beneficial cardiovascular effects in patients with acute     myocardial infarctions and dogs with dilated cardiomyopathy in that the left ventricle     function and endothelial dysfunction improves after GLP-1 treatment via insulin-independent     mechanisms. Preclinical studies indicate that exogenous administrated GLP-1 in physiological     concentrations can improve perfusion but this has never been tested in humans. It is also     unknown whether GLP-1 can directly increase the glucose/metabolite uptake across both cardiac     and skeletal muscle in an insulin independent manner. Unpublished studies do however indicate     that the improvement in the cardiovascular system is largely dependent upon a high blood     glucose level and only partially dependent upon the antiglycemic effects of GLP-1.      In the proposed studies the investigators wish to examine the physiological role of GLP-1     receptor stimulation both with regard to perfusion, metabolic improvement as well as cardiac     inotropic. These studies will be conducted in both healthy and in T2DM patients.   "
234280|NCT00923975|"     The purpose of this study is to evaluate a Diabetes data management program in the hands of     potential users, both lay persons and healthcare professionals. With this data management     system glucose results from the DIDGET TM meter can be uploaded to a secure website and used     by adults with diabetes, by parents and guardians of children with diabetes, and by health     care professionals to monitor diabetes by recognizing trends and patterns in blood sugar     levels.   "
234336|NCT00924755|"     The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as     a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary,     unilateral, open inguinal hernia repair.   "
234282|NCT00924001|"     Background:        -  This study will use cells called DMF5 to treat patients with metastatic melanoma          (melanoma that has spread beyond the primary tumor site).        -  The DMF5 cells were first obtained from a tumor of a patient with melanoma with HLA-A201          tissue type. The tumor cells were grown in the laboratory, and when the laboratory-grown          cells were given back to the patient, the patient's tumors shrank dramatically. In          laboratory tests, DMF5 cells were also shown to shrink mouse melanoma tumors.      Objectives:      -To determine whether preparatory chemotherapy followed by infusion of DMF5 cells is a safe     and effective for shrinking melanoma tumors.      Eligibility:      -Patients with metastatic melanoma and tissue type HLA-A201 who are 18 years of age or older.      Design:        -  Patients have a preparatory regimen of chemotherapy with cyclophosphamide and          fludarabine followed by infusion of DMF5 cells and then high-dose interleukin. The          chemotherapy, interleukin and cells are given intravenously (through a vein).        -  Patients have frequent blood tests to look for the side effects and response to          treatment.        -  Patients may be asked to have a tumor biopsy (surgical removal of a small piece of tumor          tissue) to examine the effects of treatment on the immune cells in the tumor.        -  Patients have a physical examination, computed tomography (CT) of the chest, abdomen and          pelvis and laboratory tests 4 to 6 weeks after treatment and then monthly to evaluate          the tumor.        -  The first group of patients participates in the Phase I portion of the study, called the          dose escalation phase. This phase will determine the highest safe dose of DMF5 cells.          There will be three dose levels of DMF5 cells, with the first patients enrolled getting          the smallest dose and then increasing the dose when the preceding level has been shown          to be safe.        -  Patients in the Phase II portion of the study receive DMF5 cells at the highest dose          found to be safe in Phase I, to test the effectiveness of the treatment.   "
234283|NCT00924014|"     The purpose of the study is to compare the effects of conivaptan and diuretics on renal blood     flow and neurohormones.   "
234284|NCT00924027|"     Background:        -  One standard way of giving radiation is to combine external beam treatments with          internal brachytherapy treatments, which involve short-range radiation therapy that          gives a high dose of radiation directly to a cancer or to the area where cancer cells          were removed.        -  Brachytherapy is done by placing hollow implant device(s) into the area to be treated          and then moving a radiation source into each. The type of device depends on the type of          cancer and the site to be treated. These devices can range from hollow applicators and          needles to balloon-like equipment.      Objectives:        -  To evaluate the quality of the brachytherapy procedure at the National Institutes of          Health s Radiation Oncology Branch.      Eligibility:        -  Patients with cancer who could potentially benefit from high-dose brachytherapy as part          of their treatment.      Design:        -  In conjunction with their existing treatment, patients will be treated with high-dose          brachytherapy as determined appropriate for their particular type of cancer and cancer          history.        -  Each treatment will take place in the Radiation Oncology Clinic.        -  If the patient does not have implant devices, the clinic staff will insert them and          check their placement through a computed tomography (CT) scan.        -  The calculations to determine the appropriate brachytherapy dose will take a few hours;          the brachytherapy treatment itself will take between 10 and 30 minutes.        -  The number of brachytherapy treatments will vary according to the individual needs and          requirements of each type of cancer and each patient.        -  Patients will return to the Radiation Oncology Clinic for followup visits at 1, 3, 6, 9,          and 12 months after the completion of radiation therapy. Followup evaluations will          include a medical history and physical examination, assessment of any side effects of          radiation therapy, and a repeat of any imaging (i.e., CT, MRI, X-ray) that was done at          baseline to evaluate the tumor response.   "
234285|NCT00924040|"     BL22 is a type of protein that scientists have created to interact with certain cancer cells.     Experiments have shown that BL22 can bind with cancer cells that have a particular kind of     protein (called CD22 ) on their surface, and can kill those cells. CD22 is present on certain     types of hairy cell leukemia (HCL) cancer cells, and researchers have been working on     treatments that will use BL22 and other related proteins to interact with and kill these     kinds of cancer cells. The primary purpose of this study will be to provide access to and     treatment with BL22 for patients who have HCL in order to determine their response to the     treatment. In addition, the study will assess potential side effects of BL22 and examine why     some patients respond better than others to treatment with BL22 and related therapies.      This study will include about 21 to 25 adults who have been diagnosed with forms of HCL that     have not responded well to standard treatments such as surgery, chemotherapy, or radiation     therapy. These adults also will have received anti-CD22 therapies before, potentially     including treatments with BL22, and have not developed immunity or resistance to these     treatments.      Prior to the study, patients will undergo a 1- to 2-week screening period to assess their     eligibility for treatment. Eligible patients will participate in the study for up to 16     cycles of treatment, with each cycle lasting approximately 4 weeks. For each cycle, patients     will receive 1 prescribed dose of BL22 every other day for a total of 3 doses per cycle, and     will be assessed after every cycle to evaluate the success of the treatment. During the     evaluation visits, patients will be required to have a brief physical examination, give blood     and urine samples for testing, and undergo other tests as need to check heart and kidney     function and assess the state of the leukemia. Patients who agree will give additional blood,     urine, or bone marrow samples for future research purposes.   "
234286|NCT00924053|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics (how     much of the drug gets into the blood and how long it takes the body to get rid of it) of     single doses of EGT0001474 given to patients with Type 2 diabetes. The study will also     evaluate how EGT0001474 affects the amount of glucose produced by the body in the urine.   "
234287|NCT00924066|"     Background:        -  Ixabepilone is a member of the class of drugs called epothilones. These drugs interfere          with the ability of cancer cells to replicate.        -  Epothilones are similar to taxanes, another class of drugs, which includes the drug          Taxol. Taxol is widely used to treat a variety of cancers.        -  Ixabepilone can work in cells that are resistant to Taxol.      Objectives:        -  To determine whether ixabepilone is effective for treating cervical cancer.      Eligibility:        -  Women 18 years of age or older with cervical cancer.      Design:        -  Patients receive ixabepilone intravenously (through a vein) over 60 minutes on the first          5 days of each 21-day treatment cycle. Their dosage may be adjusted according to how          their bodies respond to the drug.        -  The number of cycles each woman receives depends on her response to the treatment.        -  Patients have CT (computed tomography) scans and other tests before starting treatment          and then every other treatment cycle to determine the response of the tumor to          ixabepilone.        -  Patients who can undergo a tumor biopsy (surgical removal of a sample of tumor tissue)          are asked to have a biopsy done before starting treatment with ixabepilone and again on          the fourth or fifth day of treatment. This procedure is optional.   "
234288|NCT00924079|"     The purpose of this study is to investigate possible responses to pharmacokinetic properties     for nalbuphine oral formulations in healthy volunteers.   "
234296|NCT00924196|"     Background:      Neurofibromatosis Type 1 (NF1) is a genetic disorder in which patients are at increased risk     of developing tumors (usually non-cancerous) of the central and peripheral nervous system.     The disease affects essentially every organ system.      The natural course of NFI over time is poorly understood. For most patients the only     treatment option is surgery. A better understanding of NF1 may be helpful for the design of     future treatment studies.      Objectives:      To evaluate people with NF1 over 10 years in order to better understand the natural history     of the disease.      To characterize the patient population and to examine how NFI affects patients quality of     life and function.      Eligibility:      Children, adolescents, and adults with NF1.      Design:      Participants have a comprehensive baseline evaluation including genetic testing, tumor     imaging, pain and quality-of-life assessments, and neuropsychological, motor and endocrine     evaluations.      Patients are monitored every 6 months to every 3 years, depending on their individual     findings at the baseline study. Tests may include the following, as appropriate:        -  Medical history, physical examination and blood tests.        -  Whole body and face photography to monitor visible deformities.        -  Neuropsychological testing, quality-of-life evaluations, motor function tests,          endocrinologic evaluations, heart and lung function tests, hearing tests, bone density          scans and other bone evaluations.        -  MRI and PET scans to detect and assess plexiform neurofibromas (tumors that arise from          nerves and can cause serious problems), paraspinal neurofibromas (tumors that arise from          nerves around the spine and can cause problems by compressing the spinal cord), and          malignant peripheral nerve sheath tumors (a type of cancer that arises from a peripheral          nerve or involves the sheath covering the nerve).        -  Eye exams, MRI scans and PET scans to evaluate optic pathway gliomas (tumors arising          from the vision nerves or the brain areas for vision) and the chemicals within the tumor          and brain.        -  Eye exams and photographs to evaluate the development of Lisch nodules (non-cancerous          tumors on the eye).        -  Photographs of dermal neurofibromas (tumors of the skin), cafe-au-lait spots (dark or          pigmented areas on the skin that are often the first signs of NF1) and other skin          problems.        -  Pain evaluations to monitor the different types of pain patients experience, causes of          the pain, how often the pain occurs, effect of the pain on quality of life, and what          pain medications and alternative treatments, such as acupuncture, are effective....   "
234289|NCT00924092|"     Objectives:        -  To find out the maximum tolerated dose of the GI-6207 vaccine (the highest dose that          does not cause unacceptable side effects), and to evaluate any side effects.        -  To see if GI-6207 has any effect on patients tumors.        -  To learn how the vaccine causes immune responses against the cancer.      Eligibility:        -  Patients 18 years of age and older who have been diagnosed with a cancer that has not          responded to standard treatments. Patients must not be allergic to yeast or yeast          products.      Design:        -  Initial physical examination, blood and tissue sampling, computed tomography (CT) scan,          and skin test to determine eligibility for the procedure.        -  Treatment with GI-6027 in seven 14-day cycles as follows:        -  Vaccine administered on days 1, 15, 29, 43, 57, 71, and 85.        -  Vaccine given at four sites around the body: right and left chest area below the armpit,          and right and left upper thigh in the pelvic region. (These areas drain into parts of          your body that contain large numbers of lymph nodes. The lymph nodes contain immune          cells that may be activated by the vaccine to target cancer cells.)        -  Clinic visits for physical examinations to check vital signs, take additional blood and          urine samples, and perform other tests needed for the study.        -  After day 85 (about 3 months), patients will continue to receive vaccine monthly (or          every 28 days) as long as the vaccine is not producing harmful effects or side effects          and the cancer is either stable or reducing. Patients who do well on the vaccine may          continue to receive it for as long as it is available.   "
234290|NCT00924105|"     The purpose of this clinical trial is to test safety and tolerability of a vaccine targeting     Interleukin-1 beta in patients with type 2 diabetes.   "
234291|NCT00924118|"     The purpose of this study is to determine whether the intravenous infusion of sodium nitrite     safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction     resulting in improved left ventricular function.   "
234292|NCT00924131|"     Background:        -  Researchers are greatly interested in knowing more about the long-term effects of          various treatments for cancers such as Hodgkin's disease, particularly from those who          have lived 20 to 30 years after treatment.        -  Patients who were treated at the National Institutes of Health (NIH) may have undergone          different treatments for which more long-term information is needed.      Objectives:        -  To examine the body systems of long-term survivors of Hodgkin's disease to see if there          are any long- term consequences of treatment for Hodgkin's disease.        -  To learn more about the long-term effects of cancer treatments.      Eligibility:        -  Survivors of Hodgkin's disease who were previously treated at the NIH.        -  Participants must be at least 18 years of age.      Design:        -  Participants will need to sign consent forms to allow researchers to obtain          documentation of medical history, including prior treatment for Hodgkin's disease and          prior NIH treatment, including protocol number, where applicable:        -  Pertinent medical records, pathology reports, and radiographic imaging studies will be          reviewed.        -  Primary care physician's name, address, and other contact information are also required.        -  Evaluations during the assessment period:        -  Complete physical examination.        -  Laboratory studies of blood, urine, and stool samples.        -  Radiologic evaluations, including computerized tomography (CT) and magnetic resonance          imaging (MRI) scans for all participants and mammograms for females.        -  Cardiac evaluation, vascular studies, and pulmonary studies to measure heart and lung          function, and digestive tests to measure stomach and intestinal function.        -  Neurocognitive testing to measure brain function.        -  Optional skin biopsy.        -  Participants will be asked to complete questionnaires assessing current quality of life          and daily living skills.   "
234293|NCT00924157|"     This study will investigate whether the lacto-tripeptide Ile-Pro-Pro (IPP) improves the     function of the endothelium in patients with coronary artery disease. The study has a     crossover design. Participants will be treated with a protein hydrolysate rich in IPP for 12     weeks and placebo for 12 weeks with a four-week rest period between treatment periods. The     investigators will use ultrasound to test the function of the endothelium in the brachial     artery before, after 6 weeks, and after 12 weeks of each treatment. Blood will be collected     before and after each treatment. The investigators hypothesize that IPP will improve     endothelial function.   "
234294|NCT00924170|"     BACKGROUND:        -  CD25 (p55, Tac or IL2R alpha) is strongly expressed in virtually 100% of patients with          adult T-cell leukemia/lymphoma (ATL), a highly aggressive HTLV-1 related malignancy          responding poorly to chemotherapy.        -  In ATL, the humanized anti-CD25 monoclonal antibody (Mab) daclizumab produced 13-14%          responses, and the anti-CD52 Mab Alemtuzumab (Campath-1H) produced response lasting          greater than 2 months in 30% of 23 patients.        -  LMB-2 is an anti-CD25 recombinant immunotoxin containing variable domains of murine MAb          anti-Tac and truncated Pseudomonas exotoxin.        -  In a phase I trial at NCI, the MTD of LMB-2 was 40 microg/Kg IV given every other day          for 3 doses (QOD times 3). LMB-2 induced greater than 90% tumor reduction rapidly in all          3 ATL patients on protocol, but achieved only 1 partial response due to rapid tumor          progression and/or immunogenicity.        -  In preclinical models, response from recombinant immunotoxins is limited by high          concentrations of soluble receptor in the blood and especially in the interstitial space          of the tumor. Synergism was observed with chemotherapy and immunotoxins, possibly due to          reduction of soluble receptor in tumor interstitium.      OBJECTIVES:      -To determine, in nonrandomized fashion, if after verifying its safety, fludarabine and     cyclophosphamide (FC) prior to LMB2 for ATL can result in low immunogenicity and a rate of     major response lasting greater than 2 months, which may be an improvement over that     demonstrated previously from CAMPATH.      Secondary objectives:        -  To determine the effect of 1 cycle of FC alone in ATL.        -  To examine progression-free and overall survival in ATL after FC/LMB-2.        -  Evaluate pharmacokinetics, toxicity, and monitor soluble CD25 and other tumor marker          levels in the serum.        -  To study the effects of LMB-2 plus FC on normal B- and T-cell subsets by FACS.      ELIGIBILITY:        -  CD25 plus ATL, untreated or with prior therapy        -  ECOG 0-2, ANC, platelets and albumin at least 1000, 75,000, and 3.0.      DESIGN:        -  Fludarabine 25 mg/m(2) IV days 1-3        -  Cyclophosphamide 250 mg/m(2) IV days 1-3        -  LMB-2 30-40 micro g/Kg IV days 3, 5 and 7.        -  LMB-2 dose: Begin with 30 microg/Kg times 3. Escalate to 40 microg/Kg if DLT in 0/3 or          1/6 at 30 microg/Kg. Continue at 40 microg/Kg if 0-1 of 6 have DLT at 40 microg/Kg.        -  Administer cycle 1 with FC alone. Two weeks after starting cycle 1, begin up to 6 cycles          of FC plus LMB-2 at minimum 20-day intervals.        -  Accrual goals: 29-37 patients, which includes 4 replacements....   "
234295|NCT00924183|"     The primary goal of this study is to compare a new symptoms rating questionnaire, called the     Vancouver Semi-Structured Interview for Depression (V-SID), to the traditionally used     questionnaires. The investigators predict that the V-SID will be more sensitive to patients'     improvement than are traditional questionnaires.   "
234313|NCT00924443|"     The purpose of the study is to determine if treatment of older patients indicated with     untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive     chemotherapy, can effectively be treated with Clofarabine.   "
234314|NCT00924456|"     The purpose of this trial is to show that the Transcendental Meditation program can decrease     blood pressure in young adults (college students) and is associated with decreased     psychological distress and coping ability.   "
234315|NCT00924469|"     The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus     leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with     prostate cancer (a disease in which cells in the prostate gland become abnormal and start to     grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery     to remove all or part of the prostate gland).   "
234297|NCT00924209|"     Background:        -  Surgical resection is the treatment of choice for patients with lung cancer, and cure          after resection generally depends on whether lymph nodes are involved. A patient with          Stage IIIA (N2) lung cancer has cancer in the lymph nodes involving the center of the          chest (mediastinum).        -  Studies have shown that surgery alone as a treatment for Stage IIIA (N2) lung cancer is          not as effective as chemotherapy followed by surgery.        -  Giving chemotherapy upfront may prevent the spread of Stage IIIA (N2) lung cancer          tumors, and may shrink the tumors to allow adequate surgery to be performed. It is also          thought that chemotherapy is usually better tolerated before major surgery than after,          so higher doses can be given.      Objectives:        -  To determine the effectiveness of the combination of three anti-cancer drugs          (gemcitabine, cisplatin, and bevacizumab) given before surgery.        -  To find out what effects this drug combination may have on the patient and the cancer.        -  To determine if the combination of all three drugs given prior to surgery is more          effective and as safe, safer, or less safe than other drug combinations given before          surgery.      Eligibility:        -  Patients with Stage IIIA (N2) lung cancer who have not had chemotherapy, radiation, or          surgery to treat the cancer.      Design:        -  Evaluations before the treatment period to determine eligibility:        -  Physical examination, including vital signs and body weight checks, and pregnancy test          for women who can become pregnant.        -  Tests to evaluate heart and lung function, such as an echocardiogram.        -  Blood and urine tests.        -  Disease evaluation with computed tomography (CT), chest X-ray, positron emission          tomography (PET) scans, and bronchoscopy/mediastinoscopy (examinations of the inside of          the chest and lungs).        -  Treatment with intravenous gemcitabine, cisplatin, and bevacizumab for three 21-day          cycles.        -  Cycles 1 and 2 - Gemcitabine on day 1 and day 8, cisplatin on day 1, bevacizumab on day          1.        -  Cycle 3 - Gemcitabine on day 1 and day 8, cisplatin on day 1 (no bevacizumab).        -  Physical examinations and tests will be conducted throughout each cycle.        -  Surgery will take place 4 to 6 weeks after the last cycle if heart and lung functions          are satisfactory and if the cancer remains stable.        -  Chemotherapy (four 21-day cycles of cisplatin and etoposide treatments), further          evaluations and examinations, and followup studies will take place 4 to 8 weeks after          the surgery.   "
234298|NCT00924222|"     Organ protection, volatile anesthetics, postconditioning.      Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either     propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the     blood.   "
234299|NCT00924248|"     The objective of this Post Marketing Surveillance (PMS) is to gain information about safety     and efficacy in real practice   "
234300|NCT00924261|"     Based on their preliminary quantitative gait findings suggesting that limited passive hip     extension range is a key functionally limiting impairment affecting gait, the investigators     propose a supervised, specific stretching exercise with the aim to improve both peak hip     extension and overall gait performance. While one goal is to demonstrate that reduced peak     passive hip extension is a key, functionally significant, but reversible, impairment another     is to improve our understanding of the relationship between impairment, functional limitation     and gait ability.   "
234301|NCT00924274|"     Familial hypercholesterolemia (FH), an inherited disorder of lipoprotein metabolism, is a     risk for early cardiovascular disease (CVD). This autosomal dominant disease is characterized     by markedly elevated plasma concentrations of low density lipoprotein (LDL) and total     cholesterol (TC). The purpose of this study is to compare the effect of a diet low in     saturated fats but enriched either with rapeseed oil (RO) or sunflower oil (SO) in children     and adolescents with FH on serum lipoproteins.   "
234302|NCT00924287|"     Background:        -  Human epidermal growth factor receptor-2 (Her-2) is a gene found in both normal cells          and cancer cells. Extra copies of the gene (overexpression) can cause too many Her-2          proteins (receptors) to appear on the cell surface and cause tumors to grow.        -  An experimental procedure developed for treating patients with cancer uses blood cells          found in their tumors or bloodstream. The cells are genetically modified using the          anti-Her-2 gene and a type of virus. The modified cells (anti-Her-2 cells) are grown in          the laboratory and then given back to the patient to try to decrease the size of the          tumors. This is called gene therapy.      Objectives:        -  To determine whether advanced cancers that overexpress Her-2 can be treated effectively          with lymphocytes (white blood cells) that have been genetically engineered to contain an          anti-Her-2 protein.      Eligibility:        -  Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond          the original site) and for whom standard treatments are not effective.        -  Patient's tumor overexpresses Her-2.      Design:        -  Workup with scans, x-rays and other tests.        -  Leukapheresis to obtain cells for preparing the anti-Her-2 cells for later infusion.        -  1 week of chemotherapy to prepare the immune system for receiving the anti-Her-2 cells.        -  Infusion of anti-Her-2 cells, followed by interleukin-2 (IL-2) treatment. The cells are          given as an infusion through a vein. IL-2 is given as a 15-minute infusion through a          vein every 8 hours for a maximum of 15 doses.        -  Periodic follow-up clinic visits after hospital discharge for physical examination,          review of treatment side effects, laboratory tests and scans every 1 to 6 months.   "
234303|NCT00924300|"     The primary objective of this protocol is to test the feasibility and utility of obtaining     magnetoencephalography (MEG) recordings in healthy children and also in children who have a     psychiatric or developmental disorder. Secondary objectives are to examine and compare     typical and atypical motor, sensory, and cognitive functioning as recorded by MEG, and to     identify subpopulation groups for which MEG may be optimal in order to establish feasibility     of future hypothesis-driven MEG research.   "
234304|NCT00924313|"     Background:        -  Prostate cancers are difficult to see on most imaging studies such as X-rays, computed          tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and          conventional positron emission tomography (PET) scans.        -  An experimental radioactive tracer called 11C-acetate accumulates in prostate tumor          cells and may help find prostate cancers more accurately than other imaging methods.      Objectives:        -  To determine the accuracy of prostate tumor imaging using the tracer 11C-acetate.      Eligibility:        -  Patients 18 years of age and older who are undergoing surgery for localized prostate          cancer at the National Institutes of Health (NIH) Clinical Center.      Design:        -  Patients have a positron emission tomography (PET scan). For this test, an intravenous          (IV) line is placed in the patient's arm and the patient lies on a table inside the          donut shaped scanner. (11)C-acetate is injected into the vein through the catheter and          images of the lower pelvis and abdomen are obtained over 30 minutes.        -  Patients have an endorectal coil MRI scan. For this test, a tube is placed in the          rectum, just behind the prostate, to increase the amount of signal received by the          magnetic resonance (MR) unit. Other coils may be wrapped around the pelvis to further          improve the quality of the scan. The patient lies on the scanning table for about 75 to          90 minutes while images are obtained. During the scan, a contrast agent called          gadolinium is injected through an intravenous (IV) line to brighten the images.   "
234316|NCT00924482|"     1. Compare measurements of cardiac output derived from electrical measurements from          electrodes on an endotracheal tube (ECOM or Endotracheal Cardiac Output Monitor) to          those made from a pulmonary artery thermodilution catheter.        2. Establish the safety and efficacy of the ECOM system.   "
234305|NCT00924326|"     Background:      The NCI Surgery Branch has developed an experimental therapy for treating patients with B     cell lymphomas or leukemias that involves taking white blood cells from the patient, growing     them in the laboratory in large numbers, genetically modifying these specific cells with a     type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to     the patient. This type of therapy is called gene transfer. In this protocol, we are modifying     the patient s white blood cells with a retrovirus that has the gene for anti-CD19     incorporated in the retrovirus.      Objective:      The purpose of this study is to determine a safe number of these cells to infuse and to see     if these particular tumor-fighting cells (anti-CD19 cells) cause tumors to shrink.      Eligibility:      - Adults age 18-68 with B cell lymphomas or leukemias expressing the CD19 molecule.      Design:      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo     a history and physical examination, scans, x-rays, lab tests, and other tests as needed      Leukapheresis: If the patients meet all of the requirements for the study they will undergo     leukapheresis to obtain white blood cells to make the anti-CD19 cells. {Leukapheresis is a     common procedure, which removes only the white blood cells from the patient.}      Treatment: Once their cells have grown, the patients will be admitted to the hospital for the     conditioning chemotherapy and the anti-CD19 cells. They will stay in the hospital for about      4 weeks for the treatment.      Follow up: Patients will return to the clinic for a physical exam, review of side effects,     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1     year as long as their tumors are shrinking. Follow up visits will take up to 2 days.   "
234306|NCT00924339|"     Familial hypercholesterolemia (FH MIM#143890), an inherited disorder of lipoprotein     metabolism, is a risk for early cardiovascular disease (CVD). This autosomal dominant disease     is characterized by markedly elevated plasma concentrations of low density lipoprotein (LDL)     and total cholesterol (TC), typically well above the 95th percentile for age and sex (1). A     defective gene for the LDL-receptor is inherited from one parent (2). The disorder was first     noted by Müller in 1939, including familial clustering of tendon xanthomas, high serum     cholesterol and early MIs (3).      The present study aims: a) to strengthen the evidence for the hypocholesterolaemic effect of     soy protein in children and adolescents affected with FH b) to monitor the compliance of soy     consumption as a possible causal factor linked to the variable lipaemic response observed in     the previous study c) to assess certain safety markers of soy food consumption (hormone     status, thyroid function, bone metabolism) 4) to monitor the adherence to the soy     intervention additionally comprise collections of blood and urine samples.      Hypothesis 1: Soya protein-substituted diets change total and LDL-cholesterol, Apolipoprotein     B and uric acid serum concentrations.      Primary parameters: Blood analysis      Hypothesis 2: Children and adolescents with FH, in which the cholesterol, LDL-lipoprotein and     Apolipoprotein B concentration is not influenced by means of soy protein substituted diet -     is it because of a) the effect of non-responder? or b) subjects, who have no regularly     dietary soya intake.      Secondary parameters: isoflavones daidzein, glycetein, genistein and equol in the urine     samples   "
234307|NCT00924352|"     The primary objective for the Phase I portion of the study is to determine the maximum     tolerated dose (MTD) and dose limiting toxicities (DLTs) and for the Phase II portion of the     study is to evaluate progression free survival (PFS). Secondary objectives are response rate,     clinical benefit rate, and overall toxicity.   "
234308|NCT00924365|"     Background:        -  About 10,000 children in the United States have been living with HIV infection since          birth. Little is known about the long-term effects of HIV infection and its treatment on          the growth and development of these children.        -  Because of their disease, many children with HIV face additional difficulties with their          health, well-being and development, such as success in school and peer relationships.      Objectives:        -  To better understand how HIV infection and the medicines used to treat it affect the          growth and development of children, adolescents and young adults who have been infected          since birth or when they were very young.        -  To develop ways to improve the quality of life for these individuals.      Eligibility:      -HIV-infected patients who were followed by the pediatric HIV program in NCI as of December     2004, or an HIV-infected sibling of a participant.      Design:        -  Periodic evaluation of pubertal development; bone mineralization; body composition and          fat distribution; liver, kidney and heart status; and behavioral, cognitive and academic          or vocational outcome of the study group. Evaluations include the following:        -  Physical examinations, including height and weight measurements and skin-fold thickness          testing to measure body fat.        -  Review of medical records and family history.        -  Blood and urine tests, including pregnancy test in females who can bear children.        -  DEXA scans (X-ray test to measure bone strength and how much fat, muscle and bone is in          the body).        -  Neuropsychological testing, including evaluation of language, thinking and          problem-solving abilities.        -  Magnetic resonance imaging (MRI): Test using a magnetic field and radio waves to examine          brain structure and function.        -  Oral glucose tolerance test: Blood sampling before and one time after the subject drinks          a sugary solution to measure the body's ability to use sugar   "
234309|NCT00924391|"     It is becoming increasingly clear that North Americans prefer dietary approaches to enhance     health in favour of pharmaceutical approaches. Although the consumption of various     phytosterol (PS)-enriched foods have been shown to be effective in lowering plasma     cholesterol in a variety of food matrices, the lipid-lowering potential of PS-enriched     soymilk has not been investigated. Therefore, the objective of this investigation was to     examine the lipid-lowering efficacy of a PS-enriched soymilk beverage in comparison to a 1%     dairy milk control. Twenty-three hypercholesterolemic subjects (Total-cholesterol and     LDL-cholesterol ≥ 5.0 and 3.5 mmol/L, respectively) consumed 3 tetrapacs per day of a     phytosterol-enriched soy beverage providing 1.95g PS/d or a 1% dairy milk control. The study     was conducted as a 28 d controlled dietary intervention according to a completely randomized,     two-period cross-over design.   "
234310|NCT00924404|"     In this pilot study, the investigators plan to compare the efficacy of twice daily xylitol     nasal rinse with saline rinse which is the current standard, on outcomes such as quality of     life and exacerbations.   "
234311|NCT00924417|"     This is a randomized, controlled trial of a distraction protocol for peripheral intravenous     line placement in the pediatric emergency department. Patients and parents will be randomized     to one of two interventions: routine care or a teaching session about the cognitive technique     known as distraction. The study seeks to enroll children ages 4-9, who are cognitively     normal, who are without significant chronic medical illness, who are receiving intravenous     line placement as part of routine care in the pediatric emergency department. Study     investigators hypothesize that patients in the intervention group will report less pain than     patients in the control group.   "
234312|NCT00924430|"     To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin     and simvastatin acid when co-administered in healthy male subjects   "
234319|NCT00924521|"     Whole grain intake beneficially affects body weight, body fat and glucose metabolism, and the     investigators' previous work has shown that a high whole grain intake significantly reduced     body fat in the abdominal region as measured by dual energy X-ray absorptiometry (DEXA)     compared to a refined grain intake. Additional research is needed with regard to the     mechanisms by which whole grains may affect visceral adiposity and the adipokines, which have     been associated with risk for insulin resistance and type 2 diabetes. Therefore the proposed     study aims to address these issues and in addition, includes exploratory work with adipocytes     in cell culture to evaluate the effects of whole grains on adipocyte function.      Hypothesis:      There will be a greater reduction in visceral adiposity, indicators of insulin resistance     (HOMA score), improvement in inflammatory status and improvement in adipokine levels after     six weeks of a weight stable period and after six weeks of weight loss in subjects consuming     6-9 servings compared to 0 servings of whole grains per day.   "
234320|NCT00924534|"     The purpose of this study is to assess safety, tolerability, pharmacokinetics and     pharmacodynamics of SLV337 in patients with type 2 diabetes   "
234321|NCT00924547|"     Oral supplementation of patients affected by cystic fibrosis with docosahexanoic acid (DHA)     will result in normalization of the known fatty acid derangements in these patients and will     diminish the production of proinflammatory isoprostanes such as 8-isoprostane-PGF2α.   "
234322|NCT00924560|"     This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a     28-day OC regimen on bone mineral density (BMD) in adolescent females.   "
234323|NCT00924573|"     Primary objective of this study is to confirm the efficacy of HOE490 O     (glimepiride/metformin) compared with placebo on top of glimepiride in HbA1c change.      Secondary objectives of this study is to evaluate the safety of HOE490 O     (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy     parameters   "
234324|NCT00924586|"     The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients     scheduled for multi-slice CT, in a double-blind, randomized, placebo-controlled, parallel     group, multi-center study.   "
234325|NCT00924599|"     The purpose of this study is to examine the feasibility of recruiting and providing a     behavioral weight loss program prior to pregnancy to reduce gestational diabetes recurrence.   "
234326|NCT00924612|"     The purpose of the study is to determine the effect of food with various amounts of fat on     the absorption of an oral testosterone undecanoate formulation.   "
234327|NCT00924625|"     This study will be a small randomized clinical trial to test the effectiveness of     neuromuscular electrical stimulation (NMES) to improve physical function and reverse muscle     atrophy in patients with rheumatoid arthritis (RA). The investigators will also determine the     mechanism by which NMES affects muscle hypertrophy and physical function. The proposed study     will be the first step in demonstrating that NMES training is an effective alternative to     highly intense volitional exercises (VE) in individuals with RA. After baseline testing, 60     individuals with RA will be randomly assigned to a 16-week NMES program or highly intense VE     program. Both programs will be applied based on the best current clinical evidence. Subjects     will be re-assessed after intervention. Groups will be compared for differences in     performance-based and self-reported lower extremity function, muscle volume, muscle strength,     proportion and area of type I and II muscle fibers, fat content, and muscle oxidative     capacity from pre- to post-intervention. Changes in physical function, muscle volume, and     muscle strength will be correlated with proportion and area of type I and II muscle fibers,     fat content, and markers of muscle oxidative capacity.   "
234328|NCT00924638|"     The 2006 American Heart Association / American Stroke Association Council on Stroke     Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic     recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in     order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation     (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin     for stroke prevention. Physicians can best optimize the use of medicines only if they can     precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the     time to first AF by 6 months' continuous rhythm monitoring versus control treatment in     subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history     of AF.   "
234329|NCT00924651|"     RATIONALE: Physical activity may help lessen fatigue caused by cancer in patients receiving     chemotherapy. It is not yet known whether a home-based walking and resistance-band exercise     program is effective in lessening fatigue.      PURPOSE: This randomized phase III trial is studying how well exercise works in lessening     fatigue caused by cancer in patients undergoing chemotherapy.   "
234330|NCT00924664|"     The purpose of this study is to investigate the safety and efficacy of tanezumab for chronic     low back pain. Patients who were randomized and treated with study medication in a previous     chronic low back pain parent study will be eligible to enroll in this safety extension     study at the Preferred Rollover Time Point visit or at the Early Termination visit of the     parent study upon discontinuation due to lack of efficacy.   "
234331|NCT00924677|"     Chronic osteoarthritis (OA) pain of the knee is not effectively abrogated by the available     non-pharmacologic or pharmacologic treatments. Radiofrequency (RF) neurotomy is a therapeutic     alternative for chronic pain. Here, the researchers investigate the efficacy of RF neurotomy     applied to articular branches (genicular nerves) in treating knee joint pain.   "
234332|NCT00924690|"     The goal of this research study is to design messages which can help people learn more about     how to prevent colon cancer. Eligible participants will be asked to review a series of short     cancer prevention messages and share their opinions on them. Participants also need to fill     out a short survey with questions on their background and attitudes and knowledge about     physical activity and colon cancer. The whole study can be completed online and will take     less than 1 hour. After completing the entire study, participants will receive $25.      If you are interested in participating in this study, please visit the following website:      https://surveys.chaicore.com/preventcancer/   "
234333|NCT00924703|"     This study is an extension of previous rAvPAL-PEG studies. Administration of rAvPAL-PEG will     be continued to assess whether long-term dosing of rAvPAL-PEG is safe and can maintain     reduced blood Phe concentrations in PKU subjects.   "
234341|NCT00924820|"     The goal of this clinical research study is to learn if and how Avastin (bevacizumab) may     affect cancer that has spread to the meninges of the brain or the spinal cord. The safety of     this drug will also be studied.      Objectives:      1. Primary:      1. Determine preliminary response data of intravenous bevacizumab in patients with NM      a. As measured by clearance of malignant cells from the Cerebrospinal fluid (CSF) at 2, 4, 6,     12, 18, and 24 weeks, then every 8 weeks up to 54 weeks, and      b. Time to neurological progression (TTNP)      2. Secondary:        1. Evaluate the safety of intravenous bevacizumab in patients with NM        2. Further describe the efficacy of this intervention as measured by             1. improvement of MR imaging evidence of disease             2. overall survival             3. maintenance of quality of life        3. Determine effects of systemically administered bevacizumab on CSF, serum, and urine          Vascular endothelial growth factor (VEGF)levels levels        4. Correlate changes in CSF VEGF with response measurements.        5. Correlate primary tumor tissue VEGF expression with CSF VEGF levels        6. Correlate urine VEGF levels with serum and CSF VEGF levels        7. Evaluate serum and CSF VEGF index   "
234342|NCT00924833|"     Exposure of healthy subjects to high altitude hypoxia elicits changes in cardiovascular,     respiratory and metabolic features as weel as in exercise performance similar, for some     aspects, to those observed in chronic heart failure. Exposure to high altitude hypoxia     represents a suitable model to assess different treatments proposed for this pathological     condition. Our aim was to evaluate the impact of two different third-generation beta-blockers     used in heart failure (carvedilol and nebivolol) on cardiovascular, respiratory, metabolic     profile and on exercise performance at high altitude.   "
234343|NCT00924846|"     Background/Objectives: Acute hypoxemic respiratory failure (AHRF) is a frequent cause of     pediatric ICU admission. Early treatment with inhaled nitric oxide (iNO) plus conventional     mechanical ventilation (CMV) improves oxygenation, responsiveness being significantly     influenced by alveolar recruitment level. High-frequency oscillatory ventilation (HFV) is     conceptually very attractive as constant mean airway pressure optimizes lung recruitment;     this could maximize iNO effects.      Aims: To analyze the effects of HFV on oxygenation indexes in AHRF children under CMV and     iNO.      Methods: Children with AHRF (oxygenation index ≥10) aged between one month and 14 years under     CMV with PEEP≥10cmH2O and 5ppm iNO for 1h were randomly assigned to CMV (CMVG, n=12) or HFV     (HFVG, n=12) in a crossover design. Children with chronic cardiac or pulmonary diseases were     excluded. Patients were kept under one of the two ventilation modes for 8h, crossing to the     other for 8h, and then back again to complete 24h observation. Blood gas analysis,     oxygenation indexes, and hemodynamic variables were recorded at enrollment (Tind), 1h after     iNO start and then every 4h (T4h etc). The Mann-Whitney U test compared group ages and PRISM     scores, and the Fisher test genders. Moments and groups were compared by repeated measure     analysis for independent groups. Significance was considered at p<0.05.   "
234344|NCT00924859|"     The investigators aim to assess the overall accuracy of D-dimer values and FXIII activation     peptide (FXIII-AP), using a newly developed ELISA test, to exclude CVT in patients with     clinical suspicion of CVT.   "
234345|NCT00924872|"     To test the hypothesis that persons with stroke can safely and effectively learn to use power     mobility devices. The primary objective of this project is to test the hypothesis that, with     formal wheelchair skills training, people who have had a stroke and have been prescribed a     power wheelchair will have a larger improvement in performance and safety scores on the     wheelchair skills test than people who have not received wheelchair skills training.   "
234346|NCT00924885|"     The purpose of the study is to compare the pain experience between the patients that have had     their transvaginal oocytes retrieval with ultrasound guidance performed with reduced single     lumen needle (Vitrolife Sweden AB, Gothenburg) with the patients that have had follicle     aspiration needle, 1.4 outer diameter (Vitrolife Sweden AB, Gothenburg), during the     procedure.   "
234347|NCT00924898|"     This is a pilot study of treatment of acute HIV infection with a once daily regimen of     Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are:        1. To determine the safety and tolerability, and the virologic and immunologic efficacy of          FTC, TDF, and efavirenz given once daily to patients with acute HIV infection.        2. To assess the impact of once daily therapy combined with a standardized adherence          program on treatment adherence, virologic suppression, and rate of viral load decline in          blood and infectious fluids (semen, cervico-vaginal secretions).        3. To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents          among persons diagnosed with acute HIV infection in the Southeastern United States.   "
234348|NCT00924911|"     Part 1 of this study will assess the relative bioavailability of GSK1322322 administered as     one of three investigational tablets compared to powder in a bottle formulation.     Pharmacokinetics of these three tablets will be evaluated and the investigation tablet with     the optimal PK profile will be progressed to Part 2. In Part 2 the investigational tablet     selected from Part 1 will be coadministered with food alone, an H2 blocker alone, or an H2     blocker given in combination with ascorbic acid to evaluate the effect on GSK1322322     pharmacokinetics. Plasma GSK1322322 PK profile, safety, and tolerability will be assessed     from each dose group.   "
234349|NCT00924924|"     The purpose of this project is to determine if a worksite wellness intervention using a     theoretically-based self-management model increases confidence for carrying out healthy     behaviors and improves health practices of participating employees. The research questions     are: 1) does the intervention produce between group differences in behavior self-efficacy and     actual health behaviors, 2) are self-efficacy and performance of health behaviors related,     and 3) do changes in self-efficacy result in changes in behavior.   "
234350|NCT00924937|"     The purpose of this study is to compare the effects of the consumption of two different     dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular     events of persons with coronary disease.   "
234351|NCT00924950|"     The purpose of this study is to determine whether using Taclonex ointment under a hydrogel     patch is more effective than using the ointment alone in treating psoriasis. Taclonex     ointment is currently FDA approved for use on psoriasis. The hydrogel patch is a type of     adhesive pad and contains no medications. It is currently FDA approved and has been shown to     be safe and virtually free of side effects. The hypothesis is that psoriatic plaques which     are treated with Taclonex ointment under a hydrogel patch will be more effectively treated     compared to psoriatic plaques treated with Taclonex alone.   "
234352|NCT00924963|"     To measure and compare pain associated with venipuncture and peripheral intravenous catheter     insertion among pediatric emergency department patients randomized to treatment with one of     three different pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine,     J-Tip® jet injection of sterile saline, or application of 4% lidocaine topical cream. The     investigators hypothesize that J-Tip® jet injection of 1% buffered lidocaine will provide     superior local anesthesia compared to saline or lidocaine cream.   "
234353|NCT00924976|"     Representative payees, mostly family members, manage Social Security Administration funds of     more than one million people with psychiatric disabilities. Although studies show payeeship     can be used coercively, foster dependency, reduce work incentives, lead to family conflict     and even violence, there has been little systematic research on how to lower these     significant barriers to community integration.      The investigators' long term goal is to promote recovery among adults with psychiatric     disabilities who have payees by reducing downsides associated with what has been called the     nation's largest guardianship system. The investigators' objective in the current     application is to evaluate a pilot-tested, stakeholder-informed intervention that is grounded     in principles of psychiatric rehabilitation and encourages consumers with psychiatric     disabilities and their family members to collaborate within the representative payee     arrangement.   "
234354|NCT00924989|"     A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent     OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who     received at least 1 but no more than 2 prior drug regimens   "
234355|NCT00925002|"     This is a Phase 3, open-label study designed to obtain additional, long-term, open-label     safety and efficacy data for Fx-1006A and to continue to provide patients with 20 mg oral     Fx-1006A (soft gel capsule) who have completed either Protocol Fx-006 (a 1 year, open-label     extension study to Protocol Fx-005 which is a randomized, double-blind, placebo-controlled,     18-month study to evaluate the safety and efficacy of Fx-1006A) or Protocol Fx1A-201 (a Phase     2, open-label study to evaluate TTR stabilization as well as the safety and tolerability of     Fx-1006A) until market availability of Fx-1006A in individual patients' country of residence.      Patients who successfully complete Protocol Fx-006 or Fx1A-201 will report to the clinical     unit on Day 0 (Baseline) to sign the informed consent form and determine their eligibility     for Protocol Fx1A-303. In addition, on Day 0 (Baseline), patients will have their entrance     criteria reviewed and medical history and demography for all patients will be obtained. The     relevant end of study assessments from Protocols Fx1A-201 and Fx-006 will serve as Baseline     assessments for Protocol Fx1A-303 if these examinations were performed within 30 days of Day     0 (Baseline). For any patient successfully completing Protocol Fx-006, the Karnofsky     Performance Scale Index will be assessed and the cranial nerve and upper limb components of     the NIS will be performed and combined with the NIS-LL data from the end of study visit from     Protocol Fx-006.      If there is more than 30 days between the final study visit of Fx-006 or Fx1A-201 and Day 0     (Baseline) of Fx1A-303, all Day 0 study procedures will be performed (i.e., no data from the     final study visits from the previous studies will be utilized).      Eligible patients will begin once-daily dosing with 20 mg Fx-1006A at home on Day 1 (i.e.,     first dose) and will return to the clinical unit for study visits every 6 months.      Adverse events (AEs) and concomitant medication use will be collected at each 6-month visit     to the clinical unit and, if female, a urine pregnancy test will be performed. An abbreviated     physical examination (including weight and vitals signs) will be conducted at every other 6     month visit. A telephone call will be made at 3-month intervals between clinic visits to     assess safety and the use of concomitant medications.      For the evaluation of efficacy, the NIS, Norfolk QOL-DN, and Karnofsky Performance Scale     Index will be performed on an annual basis (i.e., every other 6-month visit).      An end of study visit will occur upon patient withdrawal (for any reason), program     discontinuation by the Sponsor, or upon market availability of Fx-1006A in individual     patients' country of residence.   "
234356|NCT00925015|"     The purposes of this study were to assess the safety, tolerability, pharmacokinetic     interactions, and the Human Anti-Human Antibody of dalotuzumab in combination with cetuximab     and irinotecan in participants with advanced or metastatic colorectal cancer in Japan.   "
234357|NCT00925028|"     Atrial Fibrillation is a heart condition in which people are treated with blood thinners such     as warfarin to decrease the risk of stroke. Large studies have shown that when patients     adjust their own dose of warfarin, similar to insulin, results are better.      The purpose of this study is to evaluate whether implementing this method of warfarin     management is beneficial in a Canadian primary care clinic. Patients will be educated on how     to adjust their own warfarin doses when necessary using simple charts. The success of patient     self management will be compared against management by a physician.   "
234358|NCT00925054|"     The purpose of this study is to evaluate whether weekly injections of phenylalanine ammonia     lyase (rAvPAL-PEG) can reduce blood phenylalanine concentrations in PKU subjects and whether     repeated administration is safe.   "
234359|NCT00925067|"     A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses     during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on     postoperative discomfort, chronic pain development, recurrence and male fertility aspects.   "
234360|NCT00925080|"     The purpose of this study is to evaluate safety and accuracy of the IVBG System (the     System) when used to track blood glucose in insulin treated subjects with diabetes mellitus     in an in-clinic setting for up to 72 hours (per subject). Reference blood glucose     measurements will be collected across the entire reportable range of the System (e.g., 40 400     mg/dL) with adequate sampling at the upper and lower ends of this range. IVBG System accuracy     will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI     glucose levels < 75 mg/dL, and within ±20% at YSI glucose levels >75 mg/dL).   "
234361|NCT00925093|"     Three different antibiotics are used to prevent infection in case of neurosurgery - this     study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal     fluid (surrounding the brain).   "
234363|NCT00925119|"     Beta-blockers are medications used to treat cardiovascular disease (CVD) symptoms, including     high blood pressure and chest pain. People with diabetes who receive beta-blockers may     experience adverse health effects, but the exact cause of why this happens remains unknown.     This study will examine the genetic factors that may influence how atenolol, a beta-blocker     medication, affects fat breakdown, blood sugar levels, and heart function in people with type     2 diabetes.   "
234364|NCT00925132|"     The purpose of this study is to treat metastatic melanoma with a combination of standard     chemotherapy (decitabine and Temozolomide in a dose escalation scheme) with an study drug     called panobinostat. This combination is proposed to unlock genes that may contribute to     mechanisms that cause tumor growth.      The primary objectives of this study are:        -  To evaluate the safety and tolerability of the proposed schedule of decitabine,          temozolomide and panobinostat in the treatment of metastatic melanoma.        -  To define any Dose Limiting Toxicity (DLT) and maximum tolerated dose (MTD) of the          combination of decitabine, temozolomide and panobinostat.   "
234374|NCT00925262|"     The purpose of this study is to determine the relative effectiveness of three different     mental health counseling interventions in the treatment of mental health problems commonly     affecting torture and trauma survivors living in Kurdistan, Iraq.   "
234365|NCT00925145|"     There is a move to scarless surgery and this achieved by doing laparoscopic abdominal     surgery though a single small umbilical incision. A technique for laparoscopic appendectomy     done through a single incision utilizing conventional instruments has been developed. The     operative risk of the single incision approach is no different that the standard three     incision laparoscopic appendectomy. The goal is to study the operative time, length of     hospital stay, and complications from this operation.   "
234366|NCT00925158|"     BACKGROUND: Endoscopy was first used in plastic surgery for the treatment of frontal     rhytides. This minimally invasive approach allows the treatment of frontal wrinkles using a     practical procedure that does not directly interfere with the frontalis muscle, acting only     on its antagonists.      It is also possible to treat the middle third of the face, but these evolutions depends on     special surgical instruments. Videoendoscopic approach in rhytidoplasty have been improved by     new devices and surgical instruments.      The mid third of the face can be treated in different ways. Zygomatic projection can be     achieved by the use of the Dissector Assisted Malar Elevation (DAME) procedure.      AIM: Evaluate the zygomatic projection achieved by DAME in videoendoscopic rhytidoplasties.      METHODS: 30 non-white female patients, 30 to 59 years old, will be submitted to     videoendoscopic rhytidoplasty with malar elevation by the DAME. Pre- and post-operative     facial appearance will be evaluated by digital photogrammetry.   "
234367|NCT00925171|"     Chronic obstructive pulmonary disease (COPD), a preventable and treatable condition, is a     major healthcare problem with huge human and economic costs. It affects 3 million people,     results in 1.4 million consultations, causes 30,000 deaths, and costs £800M per year in the     UK. Considerable research expenditure is devoted to finding new and expensive interventions.     However pulmonary rehabilitation (PR) is an available therapeutic option with good evidence     of benefit for patients in terms of quality of life and daily functioning.      The primary objective of the study is to evaluate the effectiveness and cost effectiveness of     the addition of a maintenance programme following pulmonary rehabilitation in patients with     COPD when compared to standard care.      The secondary objective is to identify baseline characteristics that will predict improvement     in pulmonary rehabilitation programmes and adherence to maintenance strategies. By measuring     a series of demographic, clinical, physiological, psychological and biochemical parameters     the researchers hope to be able to predict those patients who are likely to receive the     greatest benefit from pulmonary rehabilitation.      An additional objective will be to prepare a detailed maintenance programme manual. This will     be available to other centres providing pulmonary rehabilitation at the conclusion of the     study   "
234368|NCT00925184|"     The aim of this research project is to establish a students' perspective to most medical     schools in Taiwan. We expect that these surveys will provide helpful information to     candidates for selection of medical school before admission, and will also be a useful     reference guide to improve quality of medical education to our governmental policy makers.   "
234369|NCT00925197|"     The aims of the study are to prove correlation between laboratory and patient self-testing     (PST) measurements, estimation of INR variability within a target therapeutic zone and     frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve     replacement.   "
234370|NCT00925210|"     Patients presenting with solitary or multiple lung nodules often require tissue confirmation     in order to guide further management and determine if the lesion is benign or malignant.     Several bronchoscopic techniques have emerged which have significantly improved the     diagnostic yield of bronchoscopy in this setting, and in particular the combination of     peripheral Endobronchial Ultrasonography (pEBUS) and Electromagnetic Navigation Bronchoscopy     (ENB) has resulted in diagnostic yields of nearly 90%. In an attempt to reduce the     significant cost of this combined approach, the sequential use of pEBUS followed by the more     costly ENB technique only if a lesion is not identified on the ultrasound image could be as     accurate. This study aims to determine the diagnostic yield of this sequential approach in     patients with lung nodule(s).   "
234371|NCT00925223|"     Brain-derived neurotrophic factor (BDNF), originally known to be a member of the nerve growth     factor family, has aroused attention as a modulator in visceral hyperalgesia recently.     Visceral hypersensitivity is recognized as a clinical hallmark in IBS patients. So in this     study, the investigators will focus on the role of BDNF in colonic hyperalgesia in IBS     patients.   "
234372|NCT00925236|"     The research involves the establishment of a cohort including as much as possible cases of     macrothrombocytopenia related to a MYH9 syndrome and the study of mutations and     polymorphisms of MYH9 gene in all these patients. As MYH9 syndrome is an autosomal dominant     disorder, patients should be heterozygous for a MYH9 gene mutation.      The main goal of our project is looking for correlations between genotype and phenotype. It     is planned to characterize the phenotype and genotype of a cohort of patients, including     family members that will be addressed during the study in order to better understand the     platelet disorder and improve the epidemiological knowledge of MYH9 syndrome. The data will     be recorded in a database.   "
234405|NCT00915850|"     This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD),     dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel,     cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness     of the this regimen is evaluated by RECIST, time to progression and median survival time.   "
234373|NCT00925249|"     This research will help doctors interested in the usefulness of a new test to discover hidden     tuberculosis infections in patients diagnosed with rheumatoid arthritis (RA). This new test     is called Quantiferon-Gold (QFT-G). After immune system medicines that block TNF-alpha (a     protein manufactured by white blood cells to stimulate and activate the immune system in     response to infection or cancer) started to be used, the rate of tuberculosis infections in     patients treated with these medicines has increased. Doctors think that the investigators may     be missing some tuberculosis infections that were hidden before the medicine is started. This     new QFT-G test might better diagnose these hidden tuberculosis infections than the current     tuberculosis skin test, also known as a PPD/TST. The investigators would like to compare     these two tests to find out which is better at detecting these hidden infections. At the same     time the investigators will measure the strength of the patient's immune system with a blood     test. If you are being considered for a TNF-alpha inhibitor medicine, or are getting the     patient's routine PPD/TST, the investigators are asking for the patient's participation.   "
234376|NCT00925288|"     The primary objectives of this study are to determine the acceptance and potential for the     effective use of HPV vaccine in the standard and a modified schedule in female sex workers.     Secondary objectives include ascertaining the prevalence of HPV types among female sex     workers by age and sexual experience.   "
234377|NCT00925301|"     The purpose of this study is to compare the effect of AT1001 (migalastat hydrochloride)     versus placebo on kidney GL-3.   "
234378|NCT00925314|"     The purpose of this study is to assess the safety, efficacy, and immunological response to     the study product, TLI, as an adjuvant therapy in subjects with Stage III Melanoma.      Normal cells in the body have an established lifespan. Cancer cells on the other hand have     the ability to continue to divide into new cells indefinitely. More than 85% of cancer has     this ability because of an enzyme found in the cancer cell. The Investigational Product,     Transgenic Lymphocyte Immunization (TLI), is aimed at helping the immune system target this     enzyme found in most cancerous cells.      Subjects who meet all inclusion and exclusion criteria will undergo a leukapheresis in which     white blood cells will be collected and used to manufacture their own personal study product.     Subjects will receive 3 infusions of TLI roughly 1 month apart and will be followed over a 2     year period with routine laboratory draws, computed tomography (CT) scans and physical exams.   "
234379|NCT00925327|"     This is a compassionate treatment protocol for the use of the UV-X system for corneal     collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have     conditions that limit their capacity to comply with the cross-linking treatment procedures     required by ongoing clinical trials.   "
234380|NCT00925340|"     A two group randomized design will be used to test the primary hypothesis that the     experimental intervention will reduce alcohol consumption and alcohol-related negative     consequences significantly more than a comparison family-based psychoeducation condition in     both an identified alcohol-using adolescent (12- 18 years old) and his/her teenage sibling     (the sibling can be 3 years older or younger than teen with the sibling's age between 12-21     years old). The experimental condition consists of the Family Check-up, while the comparison     condition is a less intense parenting psychoeducation program. Time points will include     follow-ups at 3, 6, and 12 months.   "
234381|NCT00925353|"     The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine     gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication     to reduce discomfort during screening mammography does not result in adverse effects,     electrocardiogram (EKG) changes, or systemically toxic plasma concentration of lidocaine or     its principal metabolite, monoethylglycinexylidide (MEGX).   "
234382|NCT00925366|"     At this point in time the approach to the diagnosis of rotator cuff tendon tears is not     consensual. The French surgeons, considering they have a good experience of this method,     preferably use a shoulder CT-arthrography. Whereas in the United States surgeons rather rely     on MRI or MR-arthrography of the shoulder. However, nobody can say which of these three     examinations is most precise and gives the best information. We proposed to carry out the     three examinations at the same time in a large number of patients who needed to be operated     for a rotator cuff tendon tear and then to compare the results of each of these examinations     with the operative observations.   "
234383|NCT00925379|"     Evaluation of the frequency of familial cases of renal HYPODYSPLASIA   "
234384|NCT00925392|"     This study is being performed to measure the amount of the antibiotic doripenem (study drug)     found in the fluid and cells of the lung and blood after receiving three doses of doripenem.     The major objectives of this research are to see how much and for how long doripenem gets     into the fluids and cells of the lungs of healthy adult subjects.   "
234385|NCT00925405|"     Objectives:      The objective of this single-arm, prospective study is to perform annual mammography and MRI     breast cancer screening in women who underwent mantle-field irradiation between 1970-1995 at     M. D. Anderson Cancer Center in order to compare the ability of MRI and standard mammography     to identify breast cancer. In addition, we will determine whether the combination of breast     MRI and mammography identifies smaller, earlier-stage tumors, which would lead to improved     cure rates. We will also take the opportunity to determine the incidence and stage of breast     cancer in this high-risk cohort.   "
234386|NCT00925418|"     Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the     stop of the epithelial proliferation), abscess, or pain. In this context, this randomized,     monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention     of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer.      Primary objective:      Demonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with     Taxotere®.      Secondary objectives:      Analysis of time of protection against onycholysis Estimation of the efficiency of     cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove   "
234387|NCT00925431|"     Research has shown that weight problems are very common in fibromyalgia. Research also     suggests that overweight and obesity may contribute to worsening of fibromyalgia symptoms and     biochemical vulnerability associated with fibromyalgia. Effective weight management may be     important in not only improving general health but also better management of fibromyalgia     symptoms. Research has indicated that nutrition and coping education is important aspects of     successful weight management. In this study, the investigators are evaluating the effect of     nutrition and coping education on weight and symptom management of fibromyalgia among     overweight and obese patients.   "
234388|NCT00925444|"     The aim of this study is to compare the efficacy of FORESEAL with stapling alone or     associated with tissue sealant or glue in terms of air leakage duration after lung resection     for cancer.      Hypothesis: to show a significant difference of 1 day in the average duration of air leakage     between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).   "
234389|NCT00925457|"     The purpose of this retrospective observational study is to obtain information to confirm or     contradict the results of prior studies on domperidone and sudden cardiac death. The     population studied are the Saskatchewan residents who used domperidone or another type of     medication known as a Proton Pump Inhibitor (PPI) between 1990 and 2005. Information will be     collected from various sources including the Saskatchewan Health (SH) database and Cancer     Registry.   "
234390|NCT00925470|"     Evaluation of target organs impairment on patients suffering from high blood pressure without     known cardio vascular or renal disease, stratified on blood pressure control.   "
234391|NCT00925483|"     Given the known increased risk of heart disease in hemodialysis patients, this study aims to     evaluate the change in both size and function of the heart by using cardiac magnetic     resonance imaging (MRI) in patients undergoing either daily long (4 hours, 6 times weekly),     daily short (2 hours 6 times weekly), or alternate day conventional (4 hours, 3 times weekly)     and alternate day long (8 hours, 3 times weekly) dialysis for 6 months from randomization.     The patients are randomly put in the groups based on predetermined randomization schedule and     the cardiologist trained in cardiac MRI readings is blinded to the patient treatment     schedule. Given that changes in heart function may be seen with cardiac imaging techniques     within 6 months, the expectation is that groups on daily treatment may have better outcome     for this parameter as changes in volume and blood pressure may also be affected in a positive     way in patients on daily dialysis.   "
234392|NCT00925496|"     Overall study design:      This study is a prospective, non-randomized, multicenter postmarket clinical follow-up study     with two study arms using the two shoulder prosthesis PROMOS™ STANDARD (group A) and PROMOS     REVERSE™ (group B). The study will collect efficacy and safety data over 10 years.   "
234393|NCT00925509|"     Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by     curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of     the study is to Investigate the accuracy of implants insertion in the anteroposterior way,     using radiosurgical guidance.   "
234394|NCT00925522|"     To demonstrate that ablation with the Therapy Cool Path Duo cardiac ablation system can     eliminate ischemic VT and that its use does not result in an unacceptable risk of serious     adverse events.   "
234395|NCT00925535|"     Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis     (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may     decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of     drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.   "
234396|NCT00925548|"     EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the     indication of breast cancer following the clinical hold on the investigational new drug     application for tecemotide (L-BLP25).   "
234397|NCT00925561|"     Coronary artery disease (CAD) is an important health concern for African Americans, who are     diagnosed with CAD at high rates. Coronary artery calcification, which is characterized by     calcium deposits in the coronary arteries, is a contributing factor to CAD. This study will     examine the possible genetic causes of coronary artery calcification in African Americans.   "
234398|NCT00925574|"     The purpose of this study is to evaluate the safety and how the body affects a drug (CNTO     1959) in healthy volunteers and in patients with psoriasis.   "
234399|NCT00925587|"     The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin     alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the     correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.   "
234400|NCT00925600|"     This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or     worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab     for bone loss due to androgen deprivation therapy.   "
234401|NCT00925613|"     The purpose of this study is to determine whether exchange of the double lumen tube before     emergence with a laryngeal mask airway (Proseal) or a tracheal tube will reduce cough at     emergence.   "
234402|NCT00915811|"     The purpose of this study is to determine the safety and feasibility of conditioning with     fludarabine, busulphan and thymoglobuline in patients with myelodysplastic syndrome (MDS),     myelodysplastic/myeloproliferative disorders (MDS/MPD) or acute myeloid leukaemia (AML)     undergoing haematopoietic stem cell allograft with granulocyte colony-stimulating factor     (G-CSF)-mobilised peripheral blood stem cells (PBSC) (or bone marrow) from HLA compatible     sibling donors.   "
234403|NCT00915824|"     Potentially inappropriate prescribing is common in older patients and encompasses overuse,     misuse and underuse of medications. Potentially inappropriate prescribing is associated with     negative outcomes including adverse drug events and hospitalization.      STOPP (Screening Tool of Older Person's potentially inappropriate Prescriptions) and START     (Screening Tool to Alert doctors to Right Treatment) is a new screening tool designed to     detect instances of potentially inappropriate medication use and under-prescribing of     clinically indicated medications in older patients. The purpose of this study is to determine     whether clinical implementation of STOPP/START criteria in hospitalized older patients is     effective in improving prescribing quality.   "
234404|NCT00915837|"     This Phase 1 study will evaluate the safety, tolerability and duration of effect of a helical     intravitreal triamcinolone implant for the treatment of diabetic macular edema over a     three-year period.   "
234406|NCT00915863|"     The purpose of this study is to evaluate the incidence of complications with the isolated     Roux-en-Y reconstruction after pancreaticoduodenectomy in pancreatic tumor and periampullary     tumor patients. A prospective randomized controlled trial was conducted to compare the     incidence of complications with isolated Roux-en-Y reconstruction with those of     Billroth-II-type reconstruction after pancreaticoduodenectomy.   "
234407|NCT00915876|"     This research is studying how Vitamin D may affect blood vessels reaction to stress and blood     levels of substances that may increase blockages in the blood vessels in chronic kidney     disease (CKD) patients. Blood vessel health is worsened in CKD and some studies have shown     that Vitamin D improves blood vessel health. The type of Vitamin D being used in this study     (paricalcitol) is Food and Drug Administration (FDA) approved to treat high parathyroid     hormone levels. The purpose of this study is to find out if paricalcitol has other benefits     beyond its ability to lower parathyroid hormone levels such as improving the blood vessels     reaction to stress and decreasing blood levels of substances that may increase blockages in     the blood vessels.   "
234408|NCT00915889|"     RATIONALE: Telephone counseling may help reduce depression and anxiety and improve the     well-being and quality of life of cervical cancer survivors.      PURPOSE: This randomized clinical trial is studying how well psychosocial support works in     African-American, Latina-American, or European-American cervical cancer survivors.   "
236498|NCT00953771|"     The purpose of the study is to find out if administration of danazol with plasma exchange and     corticosteroids will reduce the number of plasma exchanges required to control Thrombotic     Thrombocytopenic Purpura (TTP).   "
234409|NCT00915902|"     High triglyceride levels are increasingly recognized in children, particularly those who are     overweight. There are no studies of treatment of high triglycerides in children and     adolescents. Fish oil is attractive because it is considered safe and effective for treating     high triglycerides in adults and has been used safely for other purposes in children. The     investigators will conduct a randomized study of Lovaza (the only prescription omega-3 fish     oil medication) in 44 children and adolescents to study efficacy in lowering triglycerides,     safety, and possible mechanisms of beneficial effects.   "
234410|NCT00915915|"     Investigation of two transdermal hormone patch formulations for contraception regarding     inhibition of ovulation over a period of 3 treatment cycles in healthy young female     volunteers   "
234411|NCT00915928|"     The project aims at investigating if treatment with the Angiotensin Converting Enzyme     inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma     will decrease the risc of recurrence.   "
234412|NCT00915941|"     The purpose of this study is to learn if chemicals from the mouth or stomach can be found in     the lungs. This may suggest a process called aspiration. This study may help us understand if     aspiration plays a role in different lung diseases.   "
234413|NCT00915954|"     Growth hormone (GH) and Insulin-like growth factor-I (IGF-I) secretion are altered in     acromegaly and type 2 Diabetes Mellitis (DM). The secretion of GH is mediated by central     hypothalamic hormones (GH Releasing Hormone and somatostatin) as well as peripheral factors     providing feedback inhibition (IGF-I and glucose, among others). The purpose of this study is     to compare growth hormone suppression after an oral glucose tolerance test (OGTT) to growth     hormone suppression after recombinant human IGF-I (rhIGF-I) administration. This study will     recruit participants with active acromegaly, type 2 diabetes mellitus, and healthy control     subjects. Each participant will undergo a screening evaluation, and three subsequent visits.     Each participant will receive a placebo subcutaneous injection, OGTT, and administration of     rhIGF-I, on separate visit days. Glucose, insulin, GH, bioactive IGF-I and IGF-I binding     proteins will be measured after each intervention. Results will be compared between the three     groups. It is predicted that the administration of rhIGF-I will demonstrate GH suppression in     all healthy subjects and subjects with type 2DM. Some acromegaly subjects may demonstrate GH     suppression in response to IGF-I administration, but not to the degree seen in healthy     subjects or type 2 DM. OGTT will demonstrate suppression of GH in normal subjects, and will     show attenuated suppression in type 2 DM and a failure of suppression in acromegaly.   "
234414|NCT00915967|"     The goal of this study is to determine whether injecting the antibiotic vancomycin directly     into surgical wounds can decrease the rate of infection following implantation of     neurosurgical devices.   "
234415|NCT00915980|"     In many studies, gastric bypass surgery led to total remission of type 2 diabetes (T2DM) as     early as 1 - 2 days after surgery before any real weight loss has occurred. This suggests     that the remission of the T2DM is due to the direct effect of the operation, more than the     secondary effect of the weight loss. The reasons for the major effect on the glucose     metabolism after gastric bypass surgery are still unaccounted for.      The aim of this project will be to unveil some of the mechanisms that explain the effect of     gastric bypass surgery on the glucose metabolism. Further more to find a better way of     testing patients that have just undergone gastric bypass surgery. It is not possible to test     patients who have just undergone gastric bypass surgery with normal oral glucose tolerance     test (OGTT) and a normal meal, because patients can only take in fluid and a normal OGTT will     often lead to dumping. Instead we will try to modify these tests - OGTT with lower glucose     level and meal-testing with a protein drink.      The hypothesis of the study is that the investigators can see changes in different hormones     and adipokines before and after surgery, even with modified OGTT and meal testing. The     project will consist of clinical trials on patients without T2DM that will undergo gastric     bypass surgery. The studies will take place before and within the first week after surgery.     The investigators will measure different hormones and adipokines after OGTT and a meal with a     protein drink. The investigators expect to see significant changes in some of the analyses     after the operation in patients undergoing gastric bypass.   "
234416|NCT00915993|"     RATIONALE: Diagnostic procedures, such as MRI, may help doctors predict a patient's response     to treatment and help plan the best treatment.      PURPOSE: This clinical trial is studying MRI in predicting response to sunitinib malate in     patients with stage IV kidney cancer.   "
234417|NCT00916006|"     This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when     applied to an area of skin containing 4-8 AK lesions on the face or scalp.   "
234458|NCT00916539|"     This trial is trying to understand if immobilization of the thumb after a non-displaced     scaphoid fracture affects recovery. The standard of care overseas is a cast that allows for     free movement of the thumb, and in the United States it is a cast that immobilizes the thumb.     This study is attempting to understand if there is a difference.   "
234418|NCT00916019|"     The investigators have previously shown that mild exercise training at the level of lactate     threshold (LT) intensity (60 min/day, 5 days/week) improves peripheral insulin sensitivity     and insulin-independent glucose disposal of glucose effectiveness, without changes in body     weight and body fat (Nishida et al, Diabetes Care, 2001; Nishida et al, Diabetes, 2004). Thus     these beneficial effects are likely related to a number of adaptations that occur in skeletal     muscle as response to exercise. In the current study, the investigators hypothesised that a     single bout of mild exercise performed at LT would be a physiological stimulator of skeletal     muscle PGC-1alpha gene, and the repetition of this exercise stimulating PGC-1alpha gene     (i.e., training) for 12 weeks would induce coordinated increases in a large number of     metabolic genes, as well as other genes potentially important in the prevention of insulin     resistance and metabolic syndrome.   "
234419|NCT00916032|"     The objective of this clinical study is to compare the pharmacokinetic parameters of 3000 IU     Advate using one 3000 IU potency vial dissolved in 5 mL diluent with that of 3000 IU Advate     using two vials of 1500 IU potency dissolved in 5 mL diluent each (administered in 10 mL     diluent in total) in previously treated patients with severe hemophilia A (factor VIII level     < 1%).   "
234420|NCT00916045|"     The purpose of this study is to determine the safety and feasibility of unrelated double and     single cord blood transplantation in patients with haematological malignancies using     reduced-intensity or myeloablative conditioning regimens.   "
234422|NCT00916071|"     To understand whether a relationship exists between eating disorders and ADHD, we seek to     clarify the prevalence of ADHD in individuals with eating disorders. To this end, we will     estimate the prevalence of ADHD, and other neuropsychiatric disorders, in outpatients with     history of an eating disorder diagnosis. Secondarily, we will identify patterns of cognitive     deficits in outpatients with history of an eating disorder diagnosis. We will also examine     whether ADHD in this population is associated with functional and familial correlates     associated with ADHD.   "
234423|NCT00916084|"     A new fixed appliance will be used to transfer the tongue force during its physiological     activity to advance the nasomaxillary complex; this method will be compared with the     traditional method which uses a facemask with a fixed appliance in the mouth.   "
234424|NCT00916097|"     Primary Objective:      To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2     in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional     radiotherapy in UCNT.      Secondary Objectives:      To evaluate:        -  The radiological response after chemotherapy and radiotherapy        -  The pathological response after chemotherapy by cavum biopsy      To estimate:        -  The duration of overall response        -  The time to progression (T.T.P)      To analyze:        -  The overall survival        -  The safety profile   "
234425|NCT00916110|"     To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in     healthy Japanese male subjects.   "
234426|NCT00916123|"     The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591     antibody in combination with docetaxel chemotherapy against metastatic, castrate-resistant     prostate cancer.   "
234427|NCT00916136|"     The purpose of this study is to determine whether there are any differences in skeletal or     cutaneous traction for the treatment of femur fractures.   "
234428|NCT00916149|"     The purpose of this study is to determine if levetiracetam (for patients with focal seizures)     or lamotrigine (for patients with generalized seizures) reduces the occurrence of interictal     discharges. The study investigates the possible correlation between reduction of interictal     discharges and improved cognitive performance.   "
234429|NCT00916162|"     The purpose of this research study is to study the effects of stopping aromatase inhibitory     (AI) therapy on breast cancer progression. Aromatase inhibitors are a class of drugs used to     treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen,     which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses     despite therapy with an AI is thought to have been resistant to AI therapy. There is     scientific evidence to suggest that resistant breast cancer cells learn to grow at the very     low levels of estrogen present on AI therapy and that increasing estrogen levels even     slightly by stopping AI therapy with inhibit the breast cancer cells. An improvement or     stabilization of breast cancer has been observed after stopping therapy with tamoxifen, a     different anti-estrogen therapy, and has been reported in the literature after stopping AI     therapy. This research study will be the first study to formally test the rate of disease     improvement (response) or stabilization after stopping AI therapy.   "
234430|NCT00916175|"     High blood sugar and adiposity are part of Metabolic syndrome (about 24% of adults harbor     it). The main approach, weight reduction, is often unattainable. Aloe Vera (barbadensis) (AV)     and cnidoscolus chayamansa (McVaugh)(CC) are two vegetables that seem to have an effect on     blood glucose and body weight.      The study aims to determine if the intake of aloe gel and/or Chaya infusion can reduce high     blood sugar in adult women with pre-diabetes (Metabolic Syndrome).      Methods: A Factorial assay, double blind, cross-over-controlled with random assignment, to     four treatments: AV and CC, AV and Placebo 1, Placebo 2 and CC, and Placebo 1 and Placebo 2,     at the outpatient clinic of the university Hospital and a community clinic.      Two treatment periods of 4 weeks intermediated by one week for wash-out.   "
234431|NCT00916188|"     The primary objective of this study is to evaluate the efficacy of different doses of black     tea (150, 300, 450, 600 ml) in the test group compared to 150 ml in the control group, in     improving oxidative stress, lipid profiles and insulin sensitivity.   "
234432|NCT00916201|"     Different compounds that might modify the glucose regulation in the central nervous system     will be evaluated in healthy volunteers. Several examinations will be performed in order to     get a detailed plan how these substances might work.   "
234433|NCT00916214|"     The aim of the project is to evaluate effectiveness of a multidimensional pharmaceutical care     plan in improving compliance among elderly polypharmacy users at community pharmacy settings.     The specific objective of the project is to determine effects of pharmaceutical care program     on medication adherence and persistence among elderly polypharmacy users.   "
234434|NCT00916227|"     This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic     syndrome (MDS) will receive investigational study drug ARRY-614.      This study has 2 parts. In the first part, patients will receive increasing doses of study     drug, given either with food or without food, in order to achieve the highest dose of the     study drug possible that will not cause unacceptable side effects. Approximately 60 patients     from the US will be enrolled in Part 1 (Completed).      In the second part of this study, patients will receive the best dose of study drug, given     either with food or without food, determined from the first part of the study and will be     followed to see what side effects and effectiveness the study drug has, if any, in treating     the cancer. Approximately 40 patients from the US will be enrolled in Part 2 (Completed).   "
234435|NCT00916240|"     Asthma is a chronic lung disease that inflames and narrows the airways. Symptoms can include     recurring periods of wheezing, chest tightness, shortness of breath, and coughing. Minority,     inner city teens are at increased risk for complications from the disease, possibly because     of poor illness management. The purpose of this study is to test the effectiveness of     Multisystemic Therapy (MST)—an intensive, home- and community-based psychotherapy—for     improving asthma management and overall health and for reducing healthcare costs for inner     city African American teens with asthma.   "
234449|NCT00916422|"     The objective of this trial is to assess the clinical efficacy of the modified extract     (depigmented and polymerised with glutaraldehyde)of the subcutaneous injection of Phleum     pratense pollen in the treatment of patients affected by allergic rhinitis/     rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass     pollen, evaluating the Score regarding Symptoms and consumption of the medication.   "
234436|NCT00916253|"     The project will improve scientific knowledge regarding a recent law applying potentially to     every french driver. It will give for the first time an indication on the impact of alerting     treatments on driving risks. It will reinforce the links between different research     environments (sleep physiopathology, clinical research, cognitive neurosciences, driver's     supervision, virtual reality, pharmacology) among the RESAT network (Réseau Eveil Sommeil     Attention Transport). It will stimulate data acquisition in technological research to better     understand the difference between real and simulated driving   "
234437|NCT00916266|"     This research investigates the use of autologous bone marrow stem cells for the treatment of     medically refractory temporal lobe epilepsy patients.   "
234438|NCT00916279|"     The study will enroll patients with angiographic evidence of in-stent restenosis of a     previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The     purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in     the native coronary system. Angiographic and clinical outcomes will be assessed.   "
234439|NCT00916292|"     The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of     a wound.   "
234440|NCT00916305|"     In 1986 The Medical Research Council estimated that 4 million UK adolescents were at risk of     hearing damage from over-exposure to loud music from personal audio players (PAPs), gigs,     clubs, pubs and festivals. Since that time social noise exposure is estimated to have tripled     to 19% of young people. The European Commission commissioned a report that estimated 5-10% of     personal audio player users are risking permanent hearing loss and tinnitus by listening to     music at high volumes for more than 1 hour a day for 5 years or more. Up to 246 million PAPs     were sold in Europe in 2008, and 200 million mobile phones, many of which now have built-in     audio players. Nevertheless, a recent survey showed that only 8% of young people identify     hearing loss as a health problem. The Royal National Institute for the Deaf (RNID) undertook     two surveys of young people in the UK to analyse listening behaviours as part of their Don't     Lose the Music campaign. As a consequence they offer listening advice given by flyers at     events and online at the dedicated website. There have been no studies to confirm if such     advice is effective in reducing noise exposure.      Aim: This study will pilot a methodology for a randomised controlled trial to test the     effectiveness of a publically-available online video in changing the listening habits of     young music lovers i.e. reduce the volume and number of hours of exposure.      Hypothesis: A video and adapted sound track demonstrating the experience of noise-induced     hearing loss and tinnitus accessed online will change the listening habits of 18-25     year-olds.   "
234441|NCT00916318|"     To evaluate the effects of a family-based intervention program intended for parents of     pre-school children (4-6 y) with overweight and obesity (according to Cole et al), and to     investigate if treatment has an effect on metabolic parameters. In a randomised controlled     trial evaluate the three separate family based intervention programs and to investigate if     treatment has an effect by correlating the parameters described above with BMI, before and     after the intervention program.   "
234442|NCT00916331|"     This prospective, randomized trial asked whether subcutaneous indwelling of vacuum drainage     has advantages over intraarticular indwelling in terms of blood loss, bleeding related     complications, and functional outcomes in primary total knee arthroplasty (TKA). The     investigators hypothesized that the subcutaneous indwelling method would reduce blood loss     with comparable bleeding-related complications and functional outcomes. The subcutaneous     indwelling group demonstrated reduced blood loss with comparable prevalence of     bleeding-related complications and functional outcomes. In conclusion, the investigators'     study verified the efficacy and absence of risks of subcutaneous indwelling method. So the     investigators propose that the subcutaneous indwelling drainage can be a good option to     address the problems related to postoperative bleeding after TKA.   "
234443|NCT00916344|"     The objective of this study is to prove the safety and efficacy of the EVIA pacemaker.     Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which     automatically measures the right atrial threshold and subsequently adjusts the pacing output.   "
234444|NCT00916357|"     This is a single-center, Phase 2, randomized, double-blind, 3-way crossover meal study in     participants with Type 2 Diabetes Mellitus (T2DM) to determine the optimum dose and compare     the pharmacokinetics (PK) and postprandial glycemic response of Humalog alone, Humalog +     recombinant human hyaluronidase PH20 (rHuPH20), and Humulin-R + rHuPH20 administered     subcutaneously.   "
234445|NCT00916370|"     To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion     (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter     in subjects with symptomatic heart disease due to a maximum of two de novo native coronary     artery lesions, each in a different epicardial vessel.   "
234446|NCT00916383|"     This study is designed to assess skin tolerability, skin irritation, and adhesion of the 350     mg Donepezil Transdermal Patch (DTP-system), following 3, 7-day applications to 3 specific     areas of the body (upper back, upper middle arm, side of torso) of elderly Alzheimer's     patients. The total application time for the DTP-system is 21 days.   "
234447|NCT00916396|"     Hypoactive Sexual Desire Disorder (HSDD) is a common syndrome characterized by low sexual     desire causing marked distress. The involvement of DHEA in sexual function is unknown,     however, DHEA treatment increased desire in depressed subjects. In the current research, we     will treat 45 women and men suffering from low sexual desire with DHEA or placebo for 6     weeks. The study's primary goal is to determine the effect of DHEA treatment on sexual     desire, and to find if there is a connection between levels of hormones and change in desire.     Outcome measures will include hormonal levels and psychological state. Our secondary goal is     to compare baseline hormones measures in individuals with low sexual desire to normal     controls. For that purpose we will measure the hormonal baseline levels among 20 normal     subjects.   "
234448|NCT00916409|"     The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy     and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care     in the treatment of newly diagnosed GBM patients. The device is an experimental, portable,     battery operated device for chronic administration of alternating electric fields (termed     TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated     electrode arrays.   "
234450|NCT00916435|"     The purpose of this study is to determine whether waveforms of the intracardiac electrograms,     acquired through an ICD, can be used:        -  to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and        -  to predict progression of heart failure in patients with ICD.   "
234451|NCT00916448|"     Excessive inflammation, production of free radicals and vascular injury are considered the     main contributors to the development of organ dysfunction in patients with severe infections     and sepsis. The endogenously produced unconjugated bilirubin is one of the most powerful     anti-oxidants of the human body and the administration of bilirubin in animal experiments has     been shown to protect from inflammation-induced death. However, bilirubin for human     administration is not yet available. Therefore, we wish to exploit one of the side effects of     atazanavir, a registered drug currently used as a protease inhibitor in HIV infected     patients. Atazanavir inhibits the enzyme UPD glucuronosyl transferase enzyme (UGT1A1) and     therefore increases endogenously produced bilirubin levels moderately. To study the effect of     hyperbilirubinemia during inflammation we will apply the human endotoxemia model. The human     endotoxemia model permits elucidation of key players in the immune response to a gram     negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel     therapeutic strategies in a standardized setting. We hypothesize that atazanavir-induced     hyperbilirubinemia has beneficial anti-inflammatory and vascular effects during human     endotoxemia.   "
234452|NCT00916461|"     The purpose of this study is to determine whether the addition of minocycline or placebo to     treatment as usual (TAU):        1. prevents the accumulation of negative symptoms and intellectual decline following a          first episode of non-affective psychosis; and        2. whether minocycline stabilizes the efficacy of antipsychotics.   "
234453|NCT00916474|"     Observational follow-up study to assess long-term response to telaprevir and to evaluate     changes in Hepatitis C virus over time.   "
234454|NCT00916487|"     The purpose of this study is to determine whether the enzymatic product Frucosin(R) is able     to degrade fructose in vivo in the small intestine of patients with known fructose     malabsorption by measuring hydrogen in the expiratory air.   "
234455|NCT00916500|"     Concurrent chemoradiation (CCRT) is the standard therapy for locally advanced cervical     cancer.      However, the most effective chemotherapy regimen is controversial. Weekly cisplatin,     hydroxyurea + cisplatin, 5-FU + cisplatin are tested in clinical trials.      Weekly cisplatin needs frequent hospital visits and had a poor compliance profile in korea.      Combination chemotherapy regimens had more adverse effects than weekly cisplatin without     improving outcomes.      We conducted a retrospective analysis comparing weekly cisplatin with cisplatin every 3 weeks     and observed favorable outcome for cisplatin every 3 weeks regimen (still not published).      Therefore, we designed a phase 2 trial evaluating the efficacy and feasibility of CCRT with     cisplatin every 3 weeks.   "
234456|NCT00916513|"     The present European survey seeks to assess quality of life and satisfaction with treatment     in people with T2DM and to appreciate disease and treatment variables including hypoglycaemia     and level of glycaemic control. It will also provide relevant information on other important     aspects such as the level of correlation of objective measures such as HbA1c with health     status, QoL and satisfaction with current treatment. Overall 5000 randomly selected patients     will be invited to participate from a representative sample of clinical practices during a     pre-specified period. The study will entail a single patient visit. Patients who agree to the     study and give their informed consent will complete questionnaires which, combined with     retrospective notes review & an HbA1c test, will allow patient, disease and treatment     variables to be collected. An HbA1c test is a finger prick test to measure glycosylated     haemoglobin in the blood indicating the level of blood glucose over the last 8-12 weeks.   "
234457|NCT00916526|"     Chronic cough is defined by its persistence beyond 8 weeks. Many conditions can explain the     existence of a bronchial inflammation. In the management of chronic cough, the search for     bronchial hyperreactivity (HRB) is recommended. The treatment relies primarily on the     prescription of inhaled corticosteroids. It has been shown recently that the existence of an     HRB with Methacholine (bronchial provocation test used in routine) does predict the     effectiveness of inhaled corticosteroid treatment in no more than 50% of cases.      It is now possible to assess the bronchial inflammation by rapid, non-invasive and     reproducible tests such that the fraction of exhaled nitric oxide (FeNO) and bronchial     provocation test with mannitol. In a retrospective study, it was shown that an increased     value of FeNO (cut-off > 35 ppb) predicts a positive response to treatment with a sensitivity     of 90% and a specificity of 80%.   "
234483|NCT00916864|"     The aim of the study is to estimate the diagnostic accuracy of a combined biomarker test     (including NMDA-Receptor fragments [NR2-peptide] and Glial fibrillary acidic protein) used to     differentiate between cerebral ischemia and intracerebral hemorrhage in patients with acute     hemispheric stroke.   "
234459|NCT00916552|"     Depression and bipolar disorder (mania and depression) may be related to problems with nerve     cells not being regenerated as fast as normal and are accompanied by cognitive difficulties     including memory, attention and planning problems. There is thus a need for better, more     efficient treatments with effects on cognitive function. Erythropoietin (Epo) is involved in     brain repair and may be a candidate for future treatment strategies. The investigators have     demonstrated that a single dose of Epo improves mood and reduces the processing of negative     emotional information in healthy volunteers similar to effects seen with antidepressants.     With the current study the investigators aim to build upon this discovery by investigating     whether repeated Epo administration has antidepressant effects and is able to reverse     cognitive difficulties in patients with depression or bipolar disorder. It is hypothesized     that Epo will improve mood in treatment-resistant depression and improve cognitive function     in this group and in patients with bipolar disorder in remission. If the study reveals     beneficial effects of Epo, this would highlight Epo as a candidate compound for future     treatment of depression and bipolar disorder, with the potential to directly promote brain     repair mechanisms.   "
234460|NCT00916565|"     The purpose of this study is to look at the function of infant formula components to optimize     the nutritional content and functionality of a marketed routine infant formula.   "
234461|NCT00916578|"     The goal of this clinical research study is to find out if Xeloda® (capecitabine) and     radiation therapy can help to control breast cancer that did not respond well to     chemotherapy.      The safety of this study treatment will also be studied.   "
234464|NCT00916617|"     This study will evaluate the safety and tolerability of bapineuzumab when administered by     subcutaneous injection. The study is open only to subjects who participated in the preceding     double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab     for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will     receive active treatment (bapineuzumab) and no subjects will receive placebo.   "
234465|NCT00916630|"     The purpose of this research study is to determine the safety of the study drug pemetrexed,     and the highest dose of this drug that can be given to people safely. Another goal of this     research study is to gain information about how the body handles pemetrexed and how     pemetrexed may work to treat the participant's lymphoma in the nervous system. Pemetrexed     (also known as Alimta) has been approved by the FDA for the treatment of some lung cancers     and has been shown to be effective in laboratory studies. Information from these studies     suggests that pemetrexed may help to treat patients with either primary or secondary central     nervous system lymphoma.   "
234466|NCT00916643|"     The objectives of this post-surveillance study are to continue to evaluate the safety and     effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by     evaluating the occurrence of death, cardiovascular events or interventions, angina, and     serious unanticipated adverse effects. Laboratory assessments will be made to document     low-density lipoprotein cholesterol (LDL-C) reduction and any effects on other blood     components. Quality of life assessments will also be made.      The study will also assess the modifications to the H.E.L.P. System, including:        -  use of a single heparin adsorber, instead of two smaller adsorbers;        -  change in the supplier of the ultrafilter (from Secon to Toray);        -  reduction in the number of blood lines from eleven to nine;        -  change from a single-layer to a two-layer precipitate filter.      The safety and efficacy of the device specific to these modifications will be evaluated by     comparing the safety and efficacy data from the patient registry to the data from the initial     clinical study on the device as originally designed.   "
234467|NCT00916656|"     This is a multinational, multicenter, prospective, open-label historically controlled Phase     IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate     (Human).      It is estimated that 150-300 patients in the U.S. suffer from afibrinogenemia. Substitution     with cryoprecipitate or alternative treatments have limited safety and efficacy.      The primary purpose of the study is to demonstrate the hemostatic efficacy of Fibrinogen     Concentrate (Human) by adequately controlling acute bleeding (spontaneous or after trauma) in     patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia).     Cryoprecipitate hemostatic efficacy data from a retrospective physician survey will be used     as a historical control.   "
234468|NCT00916669|"     The purpose of this research study is to see if adding enoxaparin sodium to standard     treatment with the chemotherapy drugs cisplatin and etoposide will help treat extensive stage     SCLC. Two different doses of enoxaparin sodium will be studied in order to determine if one     dose is more effective than the other. Enoxaparin sodium (Lovenox) is a drug that is approved     by the FDA to help treat or prevent blood clots. Results from previous research studies     suggest that adding enoxaparin sodium to standard treatment improved the response to     treatment for some study participants with various types of cancer.   "
234469|NCT00916682|"     This study seeks to provide point-of-care clinical diagnostic systems for the diagnosis of     current disease status using saliva as a sample specimen.   "
234470|NCT00916695|"     The purpose of this study is to evaluate the efficacy and safety of the treatment of true     bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel     and provisional T-stenting in the side branch) compared to the complex strategy (stent in     main vessel and T-stenting in the side branch).   "
234471|NCT00916708|"     This study aims to compare two different follow up regimens with different test intensity in     endometrial cancer treated patients.      If eligibility criteria are satisfied and the written informed consensus is obtained,     patients are stratified inside the centre according to their risk level:        -  Group 1 : patients at low risk of recurrence [stage IA G1 and stage IA G2]        -  Group 2 : patients at high-risk of recurrence [≥ stage IA G3] (Ethics Committee          amendment of 14th September 2010, use new 2010 FIGO classification for endometrial          cancer!)      In each group patients will be randomized in two regimens of follow up:        1. Minimalist (Arm 1)        2. Intensive (Arm 2)      Features of each arm are listed in Arms item.   "
234472|NCT00916721|"     Smoking is the leading cause of preventable morbidity and mortality in the US. While     approximately 70% of smokers attempt to quit each year, only 5-15% maintain abstinence for 12     months, even with effective pharmacological and psychological interventions. Novel therapies     are needed for smoking cessation and relapse prevention. Previous studies show that early     post-cessation craving or urge to smoke is a powerful predictor of relapse. A current model     of the pathogenesis of addiction maintains that a substance of abuse causes a marked increase     release in phasic dopamine release, which in turn strengthens or increases the salience of     the memory of the drug experience, leading to a powerful and persistent memory that is easily     activated, leading to drug craving and often to drug use. This highly salient memory is also     implicated in the physiological arousal associated with craving responses to smoking cues.     This process is thought to be implicated in relapse to drug use after even long periods of     abstinence. Recent animal research indicates that retrieval returns a consolidated memory     such as those associated with drug craving, to a labile state from which it must be     restabilized to persist in a process termed reconsolidation. If memories of drug-related     experiences are labile when reactivated, this could represent a window of opportunity in     which the memory of drug use that underlies drug craving can be influenced pharmacologically.     Our hypothesis is that post-reactivation administration of the B-adrenergic blocker,     propranolol, following retrieval of drug-associated memories will reduce the strength or     salience of the memory by influencing reconsolidation, a process called memory     reconsolidation blockade. In this study we will test the hypothesis that a single dose of     propranolol given one hour prior to smoking-related cue exposure (post-reactivation     treatment) will decrease psychophysiological responses to smoking cues one week later and     will predict clinical response to an ensuing series of 6 post-reactivation treatments with     script-driven imagery and propranolol. In order to do so, we propose to conduct a randomized,     double-blind, placebo-controlled trial of post-reactivation treatment with propranolol in 50     adult smokers. Outcome measures will include in physiological responses to smoking-related     cues after one and six post-reactivation treatments and smoking behavior during the treatment     and during a 3-month follow-up period.   "
234473|NCT00916734|"     The purpose of this study is to determine whether patients who meet the criteria of the     clinical prediction rule for spinal manipulation may respond more favorably to repeated     exercises according to a direction of preference (what makes the symptoms decrease). The     investigators do not know which of these two commonly-used treatments (manipulation or     specific exercise) is better to treat low back pain.   "
234574|NCT00918060|"     The purpose of this study is to evaluate clinical result including plaque index, gingival     inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after     used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in     periodontal therapy   "
234474|NCT00916747|"     Hutchinson-Gilford Progeria Syndrome (Progeria) is a rare autosomal disease that results in     premature death at a median age of 13 years due to cardiovascular and cerebralvascular     compromise. The mutation for this disease has been identified and results in a mutant form of     lamin A that cannot be de-farnesylated. This study evaluates the combination of pravastain (a     statin), lonafarnib (a farnesyltransferase inhibitor) and zoledronic acid (a bisphosphonate)     in an open label phase II efficacy trial in children with Progeria. These agents all target     farnesylation pathways at different points. Patients with genetically confirmed progeria will     be eligible for this protocol. Treatment will be initiated for 24 months duration. Clinical     and biologic parameters will be examined to assess response.   "
234475|NCT00916760|"     The objective of this trial is to assess the clinical efficacy of the modified extract     (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria     Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis     ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating     the score regarding symptoms and consumption of the medication.   "
234476|NCT00916773|"     Purposes:        1. To investigate whether patients with severe obstructive sleep apnea syndrome (OSAS) are          at higher risk for exercised-induced bronchoconstriction (EIB) due to baseline airway          inflammation compared with age, gender, and body mass index (BMI)-matched controls.        2. To investigate the effect of 3-month continuous positive airway pressure (CPAP) therapy          on EIB for patients with severe OSAS.   "
234477|NCT00916786|"     The ultimate goal of this study is to find the association between specific polymorphism of     candidate genes and medication response in attention deficit hyperactivity disorder (ADHD)     patients. These results will lead the investigators' team: (1) to resolve controversies over     inconsistent findings in previous pharmacogenetic studies; (2) to study the medication effect     on the neuropsychological functions that are useful candidate endophenotypes for ADHD; (3) to     delineate the nature and the effect of gene-gene interaction in the drug response of ADHD     patients.   "
234478|NCT00916799|"     Looking at the use of home telehealth equipment and it's place in self management and     education in patients who suffer moderate to severe Chronic Obstructive Pulmonary Disease     (COPD). The patients in this group would be those patients who traditionally suffer from     emphysema, and/or chronic bronchitis.   "
234479|NCT00916812|"     This is a study to detect the sensitivity of thyromental distance ratio as a single predictor     for difficult intubation in patients undergoing cesarean section under general anesthesia.   "
234480|NCT00916825|"     About 1/3 of newly diagnosed breast cancer patients are mothers of children who still live at     home. They face additional challenges and stress, their children are also affected by the     mother's illness. The oncological rehabilitation programme getting better together focuses     on these special family needs. This waiting-control-group study examines the effectiveness of     the intervention by accompanying the patients and their children over the course of a year     and assessing their quality of life and psychological health.   "
234481|NCT00916838|"     125 children with Type 1 Diabetes mellitis (T1DM) between 4 and 16 were recruited and 62     healthy siblings also enrolled in the study.      Children with T1DM and sibling controls ages 4 to 16 were assessed on memory and executive     control skills at entry to the study (Test 1) and after two years of close monitoring for     blood sugar events (Test 2). Diabetic children have their blood sugar tested directly before     and after cognitive testing to ensure their blood sugar is within range during the testing.     The 2-year follow-up period involves parents/child reporting any severe diabetic episode and     periodically providing the results of the diabetic child's usual blood tests from their     glucose monitoring device.      Children 7 and older also underwent high resolution MRI scans.   "
234482|NCT00916851|"     The behavioral patterns, neurocognitive and social impairments, and high heritability are the     common characteristics of autism spectrum disorders (ASD) and attention-deficit hyperactivity     disorder (ADHD), the two most common early-onset neuropsychiatric disorders. Little is known     about the discriminative validity between these two disorders. As brain imaging studies have     been recognized as an important biological tool to validate disease involving the brain, no     studies have employed this approach to distinguish the brain functioning between ASD and     ADHD. Moreover, there is lack of comprehensive data of environmental, behavioral,     neurocognitive, neuroimaging, and genetic data for healthy children. Hence, we propose this     program project involving expertise researchers in the fields of child psychiatry and     psychology, psychiatric genetics, and brain imaging studies to elucidate the     neuropathophysiology and genes & environment interactions of ASD and ADHD as comparing to     healthy controls by integrating data from environments, behavioral phenotypes,     endophenotypes, and genotypes in one study.   "
234484|NCT00916877|"     Though brain metastases are a risk in all patients with breast cancer, those with HER-2     overexpression are at significantly greater risk. One series estimated a 30% incidence of     brain metastases in this population, while another study found an incidence of approximately     40%. Traditional systemic therapies do not cross the blood brain barrier to any significant     degree or at all, but radiation treatment can be effective in the treatment of intracranial     metastases.   "
234485|NCT00916890|"     Aim of this project is to customize the choice of the strong opioid in the treatment of     cancer chronic pain through the identification of patient clinical history and pain     characteristics, moreover in the analysis the investigators will also correlate the clinical     efficacy and safety of opioid treatment with pharmacokinetic and pharmacogenetic patterns in     order to identify variables able to predict the efficacy of the treatment or the patient     susceptibility towards a specific treatment.      Furthermore with this study the investigators want to identify the pharmacogenomic     characterization responsible for pharmacokinetic variability in the conversion between     morphine and other opioids, in order to validate the currently available conversion tables     from a pharmacokinetic viewpoint, estimating the influence of the most common genetic     polymorphisms, and if this characterization could be useful and cost-effective. This study     will also focus on the specific clinical-pharmacological response in the elderly and between     male and female and on the interactions between opioids and those anticonvulsant and     antidepressant drugs routinely used in the pain therapy (study of pharmacovigilance).   "
234604|NCT00925782|"     To assess and compare the pharmacokinetics of Melphalan HCL for Injection (Propylene     Glycol-Free) versus Alkeran for Injection in multiple myeloma (MM) patients undergoing     autologous stem cell transplant (ASCT).   "
234486|NCT00916903|"     This is a a study to identify inherited disease genes. The study will use molecular     techniques to map genetic diseases using techniques such as Affymetrix SNP chips. The     powerful combination of the information generated by the Human Genome Project and technical     advances such as microarrays enables attempts to identify genes responsible for inherited     disorders more possible than ever before. Starting with even modest pedigrees of only a few     individuals, or even single individuals, it is possible to identify the gene(s) involved. It     is proposed to collect up to 20 ml of peripheral blood and/or buccal cell samples from     subjects and relevant family members. Currently the following disorders are approved for     investigation.      The current list of disorders:      Aarskog-Scott syndrome, Café-au-Lait spots, Cerebral cavernous malformation, delXp, del2q,     del10p, del11q, del12p, del13q, del14q, del16q, del17q, del18q, del Xp21, Choreoathetosis,     Congenital Vertical Talus (CVT), Clubfoot, Tarsal coalition and other congenital limb     deformities, Cystic Fibrosis (CF)-like disease, Desbuquois syndrome, Droopy Eyelid syndrome     (Ptosis), Fanconi-Bickel syndrome (FBS), FENIB (familial encephalopathy with neuroserpin     inclusion bodies), FG syndrome, Idiopathic generalised epilepsy (IGE), Renpenning syndrome,     transient neonatal diabetes with 6q UPD, translocation (13;14), translocation (3;8),     translocation (2;18), Uncharacterized familial dementia and X-linked mental retardation     (XLMR).   "
234487|NCT00916916|"     Recently lanreotide (a somatostatin analog) has come into the US marketplace as a     commercially available medication approved by the FDA for the treatment of acromegaly. Blood     levels in patients getting this drug are unknown and it may be critical to know the levels in     patients whose symptoms are poorly controlled.      This is a clinical study of a medical device where the following condition is met: This is     research on a medical device for which an investigational device exemption application (21     CFR Part 812) is not required.      The study is exempt from IDE requirements under 21 CFR 812.2(c)(3):      The participants will be 10 CSMC patients who are taking Lanreotide for clinical purposes.     After receiving an information sheet and providing verbal consent, the participants will go     to their routine blood draw. At this time, they will have an additional 10 cc plasma drawn,     which will be sent to Intersciences Institute in Inglewood California to have the lanreotide     plasma levels measured.      The key points of this study are:      Patients will have blood drawn at the same time as they are having blood drawn for routine     care to avoid unnecessary sticks.      No patient identifiers will be sent to the lab or to any investigators- all plasma tubes will     be coded by ISI as a kit and these kits will be given to the physicians. In turn the     physician will give the kit to the patients who wish to have their levels measured and the     patient will take the kit with them to their routine blood draw. Following the drawing and     processing of the blood we will request that the lab just drop the coded plasma tube (and the     patient's height weight and monthly lanreotide dose) into the mail in the prepaid mailer. The     only information that the investigators will receive is the patient's height, weight and     monthly lanreotide dose and the plasma lanreotide level.      No more than 10 cc of blood (a couple of tablespoons) will be drawn for lanreotide     measurement.      Whenever possible plasma (which would otherwise be discarded) will be used rather than     freshly drawn blood.      All plasma will be assayed at ISI.      The patient will not be charged for the lanreotide assay, an investigational assay. The assay     is currently investigational and does not have a maker at this time.   "
234488|NCT00916929|"     To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude     Medical cardiac devices.   "
234489|NCT00916942|"     This study is an open-label multi-center to evaluate the tolerability of treatment with     NGX-4010 use with pre-patch topical application of a topical anesthetic cream. This is an     open-label study. No hypothesis testing will be performed.      Eligible subjects will have PHN and a level of pain at an intensity level deemed appropriate     for open-label treatment with NGX-4010, as judged by the Investigator. Painful areas of up to     a maximum of 1000 cm2 will be pre-treated with lidocaine (2.5%)/prilocaine (2.5%) cream for     60 minutes followed by a single, 60-minute application of NGX-4010. Subjects may be on     chronic pain medication regimens, but currently will not be using any topical pain     medications on the affected areas, such as non-steroidal anti-inflammatory drugs, menthol,     methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or     capsaicin.   "
234490|NCT00916955|"     The purpose of the project is the determination of how the deletion of DNA from chromosome 22     at the q11.2 band causes the phenotypes observed in velo-cardio-facial syndrome (VCFS). In     other words, the purpose remains genotype-to-phenotype matching. Current methods includes the     use of whole genome chips and microarray analysis. Blood samples are collected for DNA from     every patient who consents from the VCFS Center at Upstate Medical University. They are     examined for phenotypic features consistent with our typical clinical evaluation. The     information from these examinations will be entered anonymously into a database. Genomic     information is then matched to clinical phenotype with appropriate statistical method     applied.   "
234491|NCT00916968|"     The purpose of this prospective, randomized study was to compare functional outcome,     radiographic results, range of motion, patients satisfaction, and fit of the femoral     component in patients receiving either a standard posterior cruciate-retaining high-flexion     (CR-flex) and gender-specific CR-flex total knee prostheses.   "
234506|NCT00917163|"     The objective of Series III Run-In Trial is to compare the performance and efficacy of the     Supralimus® sirolimus-eluting stent with the Xience V™ everolimus-eluting stent with respect     to in-stent luminal late loss at 9 months as assessed by off-line QCA. Ninety percent power     to reject the null hypothesis that the Supralimus® stent is inferior to Xience V™ in favor of     the alternative hypothesis that the Supralimus® stent is not inferior to Xience V™.   "
234492|NCT00916981|"     Treatment of nonunion, delayed union and malunion fractures of long bones remains     problematic. The definition of nonunion is a failure of the fracture to heal in six months in     a patient in whom progressive repair had not been observed radiographically between the third     and sixth month after the fracture. First of all good surgical techniques are stable     immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is     required. Numerous techniques have been developed ranging from invasive interventions     (including internal fixation with the use of bone graft or bone graft substitutes) to non     invasive procedures (ultrasound and pulsed electromagnetic fields).      Recently, autologous cell therapy was presented as an interesting approach. The concept of     such therapies is based on the effect of stem cells presented in the bone marrow and able to     be transformed in osteoblast cells. The percutaneous technique of autologous bone-marrow     grafting is a minimally invasive alternative able to produce a good healing of the fracture.     The efficacy is dependent of the concentration in progenitor cell reinjected. An optimization     of this type of treatment could be achieved using a technique to increase the differentiation     of the bone marrow cells in preosteoblasts before the injection in situ by an adequate     culture. Therefore we would like to start a pilot open study on the feasibility and the     efficacy of implantation of preosteoblasts into nonunion. Two different presentations exist:     the atrophic and the hypertrophic pseudarthrosis in relationship with radiological features     of bone proliferation at the tip of bone fragments. Some data support that atrophic and     hypertrophic nonunion fractures could have different physiopathological factors. So, in a     first time we only would evaluate the atrophic form and to determine in an open study the     effect of the implantation of preosteoblasts into atrophic nonunion.   "
234510|NCT00917215|"     What is the trend of changes in asthmatic patients' daily peak expiratory flow (PEF)     variability, pulmonary function, and quality of life (QOL) with acupuncture treatment on     specific acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1) compared with minimal     acupuncture treatment (sham control group) on non-acupoints, and no acupuncture treatment     (waiting list control group)?   "
234493|NCT00916994|"     Title: One-arm, international, multi-center with competitive recruitment, prospective study     to assess the safety and efficacy of OrthoSpace's InSpace™ in rotator cuff tear subjects     scheduled for surgery of the rotator cuff - A pivotal study      Device: OrthoSpace's Biodegradable Implanted Balloon (InSpace)      Study population: Rotator Cuff tear subjects scheduled for arthroscopy.      Number of subjects: Up to 70 subject for data analysis.      Number of sites: At least 4 sites in Israel.      Main Inclusion criteria: Informed consent, diagnosed with Rotator Cuff tear.      Main Exclusion criteria: Former surgery on affected shoulder, sever illness, significant     shoulder co morbidities.      Follow up period: 12 months. Visits at hospital before discharge at 1-2 days post     implantation, 7-10 days post implantation, 3 weeks post implantation, 6 weeks post     implantation, 3,6 and 12 months post implantation.      Primary goal: To assess the safety of the SpaceGuard in Rotator Cuff tear subjects.      Secondary goals: To assess the effectiveness of the SpaceGuard in the study population. The     effectiveness will be assessed by terms of good positioning of the SpaceGuard and subsequent     follow-up non migration, surgeon satisfaction, pain relief and time to pain relief, Range of     Motion (ROM) and time to ROM with the SpaceGuard.      Primary end point: Serious Adverse Event rate related to the device and/or system     complication.      Secondary end points: Surgeon dissatisfaction following the deployment of SpaceGuard,     migration of the balloon shown by ultrasound/ X-ray/MRI at relevant follow-up visits, lost of     ROM and pain enhancement.   "
234494|NCT00917007|"     The purpose of this research study is to more accurately measure the amount of true red blood     cell breakdown (hemolysis) in newborn babies with potentially problematic blood type mismatch     with their mothers (ABO incompatibility), and to examine how the true level of red blood cell     destruction relates to other laboratory tests obtained in newborns with jaundice.      A better understanding of the true amount of red blood cell destruction that is caused by     blood type mismatch, as well as how it relates with other laboratory tests ordered for ABO     incompatibility and red blood cell destruction, would help avoid unnecessary testing,     treatment and prolonged hospital stays in such babies.   "
234495|NCT00917020|"     The purpose of this study is to evaluate the effect of as-needed treatment with nasal carbon     dioxide in patients with Seasonal Allergic Rhinitis symptoms.   "
234496|NCT00917033|"     The purpose of this study is to examine whether orotracheal intubation in morbidly obese     patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the     Macintosh direct laryngoscope.   "
234497|NCT00917046|"     This protocol describes a randomized multicenter clinical trial designed to test the     hypothesis that a 12-week program of high-intensity interval training (HIIT) yields larger     beneficial effects in stable heart failure patients than current practice, defined as either     a similar training program with the same volume of moderate continuous training (MCT) or a     recommendation of regular exercise at moderate intensity at individual choice (RRE).   "
234498|NCT00917059|"     This study will examine whether measures of brain electrical signals taken after a week of     antidepressant medication treatment can predict whether a full treatment regimen will be     effective.   "
234499|NCT00917072|"     Study the feasibility of different educational modalities to improve resident handoff of     patient information b) Determine whether different educational modalities (powerpoint vs.     simulation workshop) lead to improved educational and (surrogate) clinical outcomes        1. Educate residents on the content and process of quality handoffs (Medical Knowledge)        2. Educate residents on good communication skills (Communication competency)        3. Improve perceived continuity of patient care, decrease adverse events related to          transfer of care. (Patient safety competency)        4. Increase providers (night residents) satisfaction with the continuity of care during          handoffs. (system-based practice/ Practice-based learning)   "
234500|NCT00917085|"     To see if infant outcomes will improve when mothers are helped to hold their preterm infants     skin-to-skin as soon as possible after birth and as often as possible and for as long as     possible each time during the next five days.   "
234501|NCT00917098|"     This study will evaluate a treatment for trichotillomania, or compulsive hair pulling, in     children and adolescents.   "
234502|NCT00917111|"     The purpose of this study is to evaluate the effect of four times a day treatment with nasal     carbon dioxide in patients with Seasonal Allergic Rhinitis symptoms.   "
234503|NCT00917124|"     It is previously reported that the cerebral oxygen desaturation during cardiac surgery is     associated with an increased incidence of cognitive impairment. The aim of this study is to     determine whether intraoperative monitoring and predetermined interventions protocol to     improve cerebral oxygenation during coronary artery bypass surgery provides benefits in     neurocognitive functions.   "
234504|NCT00917137|"     The main purposes of this study are to assess the performance characteristics of     transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and     to identify the predictor variables of a positive aspirate.   "
234505|NCT00917150|"     To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of     trough FEV1 over time as the primary endpoint.   "
237738|NCT00961090|"     A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible     under ultraviolet light which allow the surgeon to see more of the tumor for a more complete     removal.   "
234509|NCT00917202|"     Design: Single-centre, controlled study in adults with uncomplicated falciparum malaria in     the Nouna Health District, north-western Burkina Faso      Phase: Phase II      Objectives: The primary objective of this trial is to study the efficacy of different     methylene blue regimens given to adults with uncomplicated falciparum malaria in an African     area of high malaria transmission intensity.      Population: Male adults with uncomplicated malaria from Nouna town.      Sample size: N= 60 (n=20 for each group; three different dosing regimens of MB).      Treatment: The participants in the three different MB regimens will receive orally twice     daily 390 mg MB (total daily dose 780mg) over 7,5 or 3 days respectively. Treatment with the     five (three) day regimen will only start after all patients of the seven (five) days regimen     have been followed up until day 3.      Endpoints: The primary endpoint is the adequate clinical and parasitological response (ACPR)     rate on day 28. Secondary endpoints are the number of adverse events (AE) after drug intake     until day 28, clinical and parasitological failure rates on day 14 and 28, changes in     haemoglobin/haematocrit until day 28, and fever and parasite clearance time.   "
234511|NCT00917228|"     This study evaluates the feasibility of a biofeedback system aimed at reducing overpressures     during seated posture. The system consists of (1) a pressure sensors map, (2) a laptop that     couples sensors with actuators, (3) a Tongue Display Unit (TDU) consisting of a wireless     circuit embedded in a dental retainer with a matrix of electrodes. The principle of this     biofeedback system consists in (1) detecting overpressures in people who are seated over long     periods of time, (2) estimating a postural change that could reduce these overpressures and     (3) communicating this change through directional information transmitted by the TDU.      It is hypothesized that overpressures are diminished after biofeedback.   "
234512|NCT00917241|"     Antithyroid drugs are widely used in treatment of Graves' disease (GD), but after therapy     withdrawal, relapse rate is very high. The aim this trail is to evaluate the effects of     intrathyroid injection of dexamethasone combined with antithyroid drugs on patients with     newly diagnosed GD.   "
234513|NCT00917254|"     The purpose of this study is to examine the superiority of YM150 to the placebo and to     evaluate the dose-dependent response of YM150 in patients undergoing elective total knee     replacement surgery.   "
234514|NCT00917267|"     Previous studies have suggested that a once-weekly formulation of exenatide may provide     sustained glycemic control. These previous studies of exenatide once weekly have been     conducted in non-Asian populations, so this study has been developed to support the local     regulatory requirements of China, Korea, Japan, India, and Taiwan.   "
234515|NCT00917280|"     The overall purpose of this research is to learn how Parkinson's disease affects thinking and     memory in everyday life. Participation will involve thinking tests, questionnaires and     interviews about thinking and activities in everyday life.   "
234516|NCT00917293|"     The primary objective is to assess the safety and effectiveness of Pyridoxal 5'-Phosphate on     the reduction of expressed symptoms of tardive dyskinesia in patients with schizophrenia and     schizoaffective disorders.   "
234517|NCT00917306|"     The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when     applied to an area of skin containing 4-8 AK lesions on non-head locations.   "
234518|NCT00917319|"     Bundling infection control interventions should decrease incidence of Healthcare-Associated     Infections in General Medical Wards at Siriraj Hospital, Bangkok, Thailand   "
234519|NCT00917332|"     The purpose of this study is to determine whether relaxation and guided imagery techniques     are effective in reducing childbirth pain.   "
234520|NCT00917345|"     Background: The most common pharmacologic test for diagnosis of primary aldosteronism (PA) is     administration of captopril to examine whether abnormal aldosterone to plasma rennin activity     (PRA)(ARR) persists, although active rennin concentration (ARC) in contrast to PRA may offers     advantages with regard to processing and standardization.      Objective: To assess whether post captopril ARC offer any additional advantage in screening     primary aldosteronism (PA) than PRA and establish thresholds for the diagnosis using ARC.   "
234521|NCT00917358|"     Interferon-based monotherapy has been considered effective to treat acute hepatitis C in     ordinary patients. However, the efficacy of this treatment has not been evaluated in     prospective interventional studies for dialysis patients. The aim of the study is the     evaluate the efficacy of peginterferon alfa-2a monotherapy for 24 weeks in this special     clinical setting, and concomitantly evaluate retrospectively the dialysis patients with acute     hepatitis C who did not receive intervention as the reference.   "
234522|NCT00917371|"     Attention deficit/hyperactivity disorder (ADHD) has been recognized as a common (5-8%),     early-onset, long-term impairing, heterogeneous neuropsychiatric disorder with high     heritability. Pharmacotherapy (methylphenidate and atomoxetine) has been proved to be the     most effective treatment for ADHD. Gau (PI) has done extensive research on ADHD and published     7 SCI papers in ADHD pharmacotherapy. The PI published the first paper in the effectiveness     of atomoxetine in improving executive functions among 30 boys with ADHD in the world     (International Journal of Neuropsychopharmacology, 2009 Oct 23:1-14. [Epub]). Due to its     lifelong impairments up to adulthood, adult ADHD has drawn much more attention in Western     studies in the past decade; however, there is lack of such information in Asian population     except the PI's three SCI papers on adult ADHD. Because little is known about atomoxetine     effect in adults with ADHD except symptoms reduction, this proposal aims to investigate the     efficacy of atomoxetine beyond symptoms improvement. The significance of this project is its     novelty and research and clinical relevance because there is lack of information regarding     long-term effect of atomoxetine on neuropsychological and brain imaging functions on adults     with ADHD, a high-prevalent mental disorder with long-term impairment in adults.   "
234523|NCT00917384|"     The purpose of this study is to gather information about the use of an investigational drug     called Ramucirumab in adenocarcinomas of the stomach or gastroesophageal junction.   "
234524|NCT00917397|"     The purpose of the study is to investigate the effect of treatment of traumatized refugees     with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point     towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy     being the most effective treatments of PTSD, but very little evidence of treatment effects     exist for the group of multitraumatized refugees. This study therefore seeks to investigate     the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or     Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual     will undergo treatment. They will be randomized to 4 different groups: antidepressants,     psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures     include symptoms, life quality and function. Patients with a diagnosis of drug abuse or     psychosis will not be included. The hypothesis is that a combination of antidepressants and     psychotherapy will be more effective than either of the two treatment regimes on their own.   "
234525|NCT00917410|"     The study aims at providing information on how the Short Message Service (SMS) tool     influences self-management in asthma patients and to assess the resulting health related     effect. A wide range of models and theories exist in the compliance area, such as technical     models, communication models, cognitive models and self-management models and theories. The     use of some of these theories and models will serve as theoretical and explanatory tools for     studying how and why the SMS tool influences the patient's self-management.      Objective:      The objective of this study is to assess the health-related effects of a SMS compliance and     monitoring system for optimized asthma treatment in a controlled trial setting.   "
234528|NCT00917449|"     Aim      The principal objective of this project is:      • To evaluate the efficacy of long term (18 months) L-Arginine therapy in preventing or     delaying clinical onset of type 2 diabetes mellitus in subjects with impaired glucose     tolerance (IGT) and Metabolic Syndrome.      Secondary end points are:        1. To define if a long term treatment with L-arginine is able to ameliorate insulin          sensitivity and endothelial dysfunction in this population.        2. To find new risk profiles and candidate genes able to define the sub-group of patients          at higher risk to develop type 2 diabetes mellitus.      Methodology This is a double blind, parallel, one centre study to determine if long term oral     L-arginine administration is able to delay or prevent type 2 diabetes mellitus in patients     with Metabolic Syndrome. Two hundred and ninety four subjects were recruited at the     Cardio-Metabolic and Clinical Trials Unit of the San Raffaele Scientific Institute. One     hundred and forty two patients were randomized to enter the study and assigned to two arms:     oral L-arginine (6.4 g/die) or placebo, in addition to diet and physical exercise. The     treatment were maintained for 18 months. Visits were performed every 3 months for clinical     evaluation, blood samples, treatment supply and collection of data on adverse events.     Furthermore, patients were contacted every month by telephone to evaluate the accurate     continuation of the study and they were instructed to phone to the centre in case of possible     adverse events.      An OGTT were performed before the enter into the study and at the end of the study period. An     additional OGTT were performed at an intermediate visit if fasting glucose levels were more     than 126 mg/dl. A diabetic response caused the end-point of the patient. Metabolic, hormonal     and endothelial activation and inflammation parameters were measured. Evaluation of     endothelium-mediated and non-endothelium-mediated vasodilatation were performed by strain     gauche plethysmography evaluating forearm blood at the basal state. in post-ischemic     conditions and after nitroglycerine administration.      Before the enter into the study, an additional blood sample were drawn for DNA extraction and     candidate genes variants evaluation. Before the enter into the study and at the end of the     study period, gene expression for inflammation were measured on mRNA extraction on     endothelial progenitor cells.   "
234529|NCT00917462|"     Sorafenib is a drug being studied for the treatment of cancer. Sorafenib has been shown to     block certain proteins on the surface of some cancer cells called growth factor receptors.     Blocking these growth factor receptors can slow or stop cancer cell growth.      Sorafenib is also known as Nexavar®. It has been studied in other types of cancers, including     kidney cancer, and has been approved by the Food and Drug Administration (FDA) for treating     advanced kidney cancer. Because it is not approved by the FDA for treating esophageal cancer,     it is considered an experimental treatment.      The purpose of this study is to determine what effects sorafenib has on advanced esophageal     cancer. These effects include whether sorafenib can shrink the tumor or slow down its growth     and what side effects sorafenib will have on the tumor.   "
234530|NCT00917475|"     With advances in medicine and medical technology, premature infants born as early as 24 weeks     of gestation and with birth weight less than 1000 grams are surviving today. Preterms are     born with immature biological systems. Given their biological vulnerabilities, preterm     infants are at risk for a variety of health and developmental problems.      As a group, preterms show developmental delays in physical growth, motor skills, attention,     social communicative skills, intelligence, language, academic performance, and later behavior     problems. Furthermore, research indicates that preterms are difficult social partners for     their parents.      Despite biological insults and relational difficulties, research also shows that the     development of premature infants appears to be facilitated by sensitive and responsive     parenting. Little attention, however, has been paid to understand the social risks faced by     preterm infants.      The proposed research, therefore, is designed to:        1. understand the extent to which neurophysiological risk may affect preterm infants'          socioemotional development,        2. explore the role of maternal social support, sociopsychological stress, and perception          of infant vulnerability in the socioemotional development of preterm infants varying in          biological risk,        3. examine the role of social support in buffering stress in mothers of preterm infants,          and        4. evaluate the role of maternal stress, coping, and support in preterm infants'          socioemotional development.      This study will include preterm infants recruited from the National Taiwan University     Hospital at term and 12 months of corrected age. Infants will be examined for physical     growth, neurobehavioral development, and mother and infant interaction at term. The growth     measures including weight, height and head circumference will be assessed. Interaction     between mother and infant will be investigated by observing the interaction between infants     and their mothers in feeding and skin to skin contact conditions. Mothers' psychosocial     stress and social support will be obtained via questionnaires.      It is expected that preterm infants' physical growth and neurobehavioral development as well     as mothers' psychosocial stress and social support are associated with the quality of     mother-infant interaction.   "
234531|NCT00917488|"     The main purpose of the trial is to prove the therapeutic value of the product and enable an     effective and safe dosage schedule to be recommended   "
234546|NCT00917683|"     Previously it has been shown that Familial Encephalopathy with neuroserpin inclusion bodies     (FENIB) patients develop abnormalities that partially overlap with Autism Spectrum disorders     (ASD), confounded with additional features that could be explained by inclusion body     formation not expected in subjects with inclusion body forming SERPINI1 mutations. There is     no described human neuroserpin deficiency phenotype. The neuroserpin knockout mouse phenotype     also suggests a possible overlap with autism. Neuroserpin could contribute directly at the     synapse or through altered neuron migration during early development leading to the     underconnectivity that underlies autism by potentially contributing to the excess of short     connections and not enough long ones seen in autistic brains, possibly due to an imbalance in     pruning of neurons and synapses early in life. It is thus proposed to sequence the     neuroserpin gene in initially 20, and subsequently up to 100 idiopathic autistic patients     selected as having the language impairment and perseveration endophenotypes.   "
234532|NCT00917501|"     The purpose of this study is to see if taking a substance called omega-3 fatty acids is     effective, safe, and well-tolerated for treating adolescents with major depressive disorder     (also called simply depression or clinical depression). Another purpose of this study is     to see how much omega-3 fatty acids are in a patient's blood and if that makes the patient     more or less likely to develop mania (i.e. periods of irritability or extreme silliness     accompanied by decreased need for sleep, risky behaviors, feeling like the patient has     special abilities, inability to sit still, and rapid speech) in the future. Yet another     purpose of this study is to see how taking omega-3 fatty acids affect brain scans. Omega-3     fatty acids are not United States Food and Drug Administration (FDA)-approved to treat     depression in adults or in children and adolescents.      Omega-3 fatty acids can only be obtained through diet, most often from fish and other sea     foods, though they are also found in other food sources such as flax seed. Omega-3 fatty     acids have been shown to play a role in affecting brain chemicals responsible for regulating     mood and have been found to reduce symptoms of depression in medicated-patients with major     depressive disorder.      By completing this study, the investigators hope to better understand who benefits from     treatment, why they do or do not respond to medications, and who is at greater risk for     developing further mental illness. With this information, the investigators hope to be able     to improve treatment and outcome in people with major depressive disorder.   "
234533|NCT00917514|"     This is a study of the electronical dosing tool MedicPen and it's qualities with regards to     user friendliness and medication compliance.   "
234534|NCT00917527|"     The aim of this prospective study is to investigate the prevalence of endothelial dysfunction     in subjects with family history of premature coronary heart disease. At the same time, the     effect of atorvastatin in treating subclinical endothelial dysfunction in those patients will     be evaluated.   "
234957|NCT00928668|"     The primary objective of this study is to assess the efficacy (bronchoprotection) and safety     of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the     Respimat® inhaler, in patients with intermittent asthma.   "
234535|NCT00917540|"     The purpose of the present study is to develop a biological prognostic index in patients with     Binet stage A Chronic Lymphocytic Leukemia (CLL) who do not necessitate therapy according to     NCI guidelines and to prospectively validate the proposed score system based on the     absence/presence of 1, 2 or 3 unfavorable prognostic markers such as cluster of     differentiation 38 (CD38) expression, Zap-70 expression and immunoglobulin heavy chain     variable region (IgVH) configuration.   "
234536|NCT00917553|"     This 24 month randomized research study will evaluate whether doxycycline can slow the     deterioration or improve retinal function among patients with mild to moderate     non-proliferative diabetic retinopathy.   "
234537|NCT00917566|"     This study indented to evaluate the use of Optical laryngoscope in pediatric   "
234538|NCT00917579|"     • To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial     atorvastatin tablets (Lipitor®).   "
234539|NCT00917592|"     Medical treatment of uncomplicated acute diverticulitis is not standardized and there is an     enormous diversity in clinical practice. The investigators' aim was to demonstrate that     uncomplicated diverticulitis can be managed with oral amoxicillin plus clavulanic acid with a     short hospital admission.   "
234540|NCT00917605|"     This project consists of two parts: Robotic Rehabilitation Trials, and Study of Outcome     Predictors and Clinimetric Attributes. In the first part of study, the investigators aim to     (1) investigate the treatment effects of robot-assisted therapy (RAT) in patients with stroke     on various outcomes, (2) test the dose-response relations by using two different intensities     (higher versus lower intensity RAT), and (3) investigate the effects of the training     intensity on a biomarker of oxidative stress. Treatment outcomes will encompass the spectrum     of functioning including motor ability, motor control strategies, basic/extended daily     functions, mobility, community reintegration, quality of life, and biomarker (8-OHdG). In the     second part of study, the purposes are to define the appropriate populations for RAT and to     examine the clinimetric properties of clinical measures relevant for use in robotic     rehabilitation research. the investigators will identify the clinical predictors that will     potentially influence the functional outcomes after interventions. Finally, the investigators     will examine and compare the clinimetric properties (e.g., validity and responsiveness) of     the clinical measures of rehabilitation outcome to inform selection of test instruments that     may detect clinically meaningful change after rehabilitation therapy.   "
234541|NCT00917618|"     Hypothesis: Group cycling classes (Spinning®) will improve pain and functional outcomes in     patients with knee osteoarthritis      Methods: Patients with symptomatic knee OA will be randomized to active Spinning® classes 2-3     per week or control group for 3 months. Outcomes including gait speed, WOMAC, KOOS, KOS, and     VAS pain at rest and after 6 min walk will be performed at baseline and at 12 weeks.   "
234542|NCT00917631|"     A rising number of preterm twins, at high risk of undergoing repeated medical procedures     often without adequate pain relief, are being admitted to Neonatal Intensive Care Units.     Skin-to-skin contact between mothers and their infants during painful procedures has been     shown to decrease pain and help them stabilize more quickly afterwards. The main question of     this study is whether the contact of a twin could provide a similar form of comfort.     Sixty-four twin pairs will have an equal chance of undergoing a medically necessary heel     stick while being cared for together (co-bedding) or separately. Primary outcome will be     physiologic and behavioral pain response. If found to be beneficial, changes to neonatal care     practices to include co-bedding may help twins tolerate and recover from painful procedures.     Findings will help care providers make recommendations for at risk twins experiencing     procedural pain and add to existing theoretical models with respect to the exact mechanism of     comfort through touch.   "
234543|NCT00917644|"     To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial     atorvastatin tablets (Lipitor®).   "
234544|NCT00917657|"     To assess the efficacy, predictability, stability and safety of corneal wavefront-guided     photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial     keratotomy (RK).   "
234545|NCT00917670|"     Ultrastructural analysis of trabeculectomy specimens of patients with uveitic secondary     glaucoma.      To evaluate morphological changes and to compare to primary open angle glaucoma patients.   "
234547|NCT00917696|"     This study will evaluate ATP-induced Pain (AIP) and ATP-induced dermal vasodilation (AIDV) as     target engagement tools for future development of analgesics.   "
234548|NCT00917709|"     The general aim of this research project is to determine the relationships between     alterations of central cholinergic (ACh) and dopaminergic (DA) systems and neurobehavioral     features of dementias with Lewy bodies (DLB).      Both clinical and neurochemical data support the view that DLB is not a homogeneous entity     and it can be hypothesized that differential alterations of central ACh systems (i.e.     anterior vs posterior vs striatal interneurons) in association or not with a DA nigrostriatal     dysfunction could partly support the clinical heterogeneity observed in this disease. ACh in     vivo imaging has been relatively underutilized to date and to our knowledge only on the     postsynaptic side. Furthermore, ACh/DA interactions and their relationships with the     symptomatology of DLB and related pathologies (PDD) had never been investigated.   "
234549|NCT00917722|"     In this study, the investigators will follow patients who have had stimulators implanted, at     their usual clinic follow-up appointments 3, 6, 9 and 12 months after surgery. It is typical     at these appointments for patients to be off medication and for the stimulators to be turned     off to observe disease progress and test stimulator effectiveness. Also as part of standard     clinical practice, stimulator settings are adjusted for optimal benefit to motor symptoms.     Only patients who already have implants will be invited to participate in this study, and no     changes to stimulator settings are made for the purposes of this study. Stimulator settings     are changed based on clinical evaluation of motor symptoms, and this study has no bearing on     how stimulators will be set nor how often they will be set.   "
234627|NCT00926289|"     The primary objective of this trial is to demonstrate that the fixed-dose combination of     T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood     Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3     hypertension (SBP>=160 mmHg and Diastolic Blood Pressure(DBP)>=100 mmHg).   "
234628|NCT00926302|"     The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra     administered under fasting conditions to healthy adult subjects.   "
234550|NCT00917735|"     RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of     breast cancer.      PURPOSE: This phase II trial is studying how well green tea extract works in preventing     breast cancer compared to a placebo in postmenopausal women with high breast density.      The investigators have hypothesized that green tea consumption reduces breast cancer risk,     and this effect is seen primarily in women who have the low-activity COMT genotype. The     investigators will test this by evaluating the effects of green tea extract on breast cancer     biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF     binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding     globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.   "
234551|NCT00917748|"     The primary objective is:        -  To determine the efficacy of modafinil in the reduction of fatigue in patients with          metastatic breast or prostate cancer undergoing docetaxel-based chemotherapy      The secondary objectives are:        -  To determine the effect of modafinil on quality of life (QoL) during docetaxel-based          chemotherapy        -  To determine the effect of modafinil on patients physical activity level, functional          status, number of chemotherapy cycles tolerated, sleep disturbance and depression,          during docetaxel-based chemotherapy        -  To investigate the impact of tumour type, patient physical activity level, functional          status, sleep disturbance and depression on the efficacy of modafinil at improving          fatigue and quality of life during docetaxel-based chemotherapy.        -  To determine the safety and tolerability of modafinil during docetaxel-based          chemotherapy   "
234552|NCT00917761|"     Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with     HBeAg negative CHB, with the overall ALT normalization and HBV viral suppression far from     satisfactory. Therefore, efforts on the various combinations with the currently available     drugs are needed to improve the overall response rates. The simultaneous combination therapy     with oral nucleoside and peginterferon alfa-2a from large-scaled randomized trials did not     show a superior response rate over peginterferon alfa-2a monotherapy. Recently, sequential     monotherapy with lamivudine for the first 4 weeks, followed by weekly peginterferon alfa-2a     has shown favorable HBeAg seroconversion rate over peginterferon alfa-2a monotherapy, based     on the assumption that early viral suppression by lamivudine can restore the immune function     to facilitate the later immunomodulatory response by peginterferon alfa-2a. Furthermore,     prior studies using 24 months of standard interferon alfa showed better ALT normalization and     HBV suppression rates to 12 months of therapy. With the recent introduction of entecavir, the     more potent oral nucleoside with few drug resistance, sequential monotherapy with entecavir     can potently suppress HBV DNA with 4 weeks of treatment, which may facilitate the response of     peginterferon alfa-2a to achieve HBV viral suppression. Therefore, we aimed to conduct a     placebo controlled randomized control trial to evaluate if adding entecavir early in the     course of therapy or extending the treatment duration of peginterferon alfa-2a can improve     the treatment response.   "
234553|NCT00917774|"     The purpose of this study was to compare functional and radiographic results, range of motion     of the knee, patient satisfaction, femoral component, revision and complication rates in     patients receiving either a standard posterior cruciate substituting-flex (LPS-flex) or     gender-specific posterior cruciate substituting-flex (LPS-Flex) total knee prosthesis.   "
234554|NCT00917787|"     The purpose of this study is to analyze markers of inflammation in blood and in induced     sputum for the purpose of identifying molecular markers of specific asthma phenotypes. The     investigators' specific interest is demonstrating that periostin levels are higher than     normal in blood. The investigators already have solid preliminary data to support this     hypothesis, and our goal here is to replicate preliminary findings and extend them by     examining further the characteristics of the asthma subgroup with elevated periostin levels.   "
234555|NCT00917800|"     The purpose of the investigation is to verify the efficiency of the HyperQ™ system in     detecting exercise induced ischemia, with higher specificity and sensitivity than     conventional ECG Stress testing. The study will be carried out by applying the HyperQ™ system     during cycle ergometer stress testing in patients who are referred for angiography at the     Department of Cardiology, Essen University Hospital, Essen, Germany. The HyperQ™ results will     then be compared to the standard ECG stress test results using the angiography results as the     gold standard. The study will be considered successful if analysis of the HyperQ provides a     statistically significant improvement over the diagnostic accuracy of conventional ECG stress     testing analysis.   "
234556|NCT00917813|"     The purpose of this study is to evaluate the safety and tolerability of 3 infusions of KD-247     over 2 weeks in HIV-1 seropositive individuals; to determine the pharmacokinetic parameters     of KD-247 when administered as above; and to assess the effect of KD-247 infusions on plasma     HIV-1 ribonucleic acid (RNA) load and on CD4+ T cell counts.   "
234560|NCT00917865|"     The purpose of this research project is to test if a compound (chemical substance) has a     natural tendency to go to prostate cancer. This compound has a small amount of radioactivity     attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be     detected on a special imaging device called a PET scanner (positron emission tomography). The     radiotracer is treated in the body much like an amino acid which is a nutrient required for     normal functioning. Tumors also use these nutrients. Earlier studies have shown that this     radiotracer may be able to detect prostate cancer.      The investigators will perform a study with 20 patients in whom they know have prostate     cancer after a biopsy and who are scheduled for an operation in which the prostate is removed     and the nearby lymph nodes are examined. This operation is called prostatectomy. The     investigators think that this radiotracer can help us determine where exactly the prostate     cancer is present in the prostate or if it has spread. This information may be useful in the     future to help with other non-surgical therapy such as radiation beam therapy.      The investigators will compare the results of the FACBC PET scan to the results of the     pathology analysis of the removed prostate. In this way the investigators can determine how     good a test FACBC PET is for finding out where and if prostate cancer is located in the     prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the     biopsy samples to see if they can tell why FACBC goes into prostate cancer cells.      This radiotracer has been tested in over 100 human subjects without incident. It has also     been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is     funding this study.   "
234564|NCT00917917|"     Metabolic syndrome has been defined as a group of associated risk factors for cardio-vascular     diseases and diabetes. It is usually treated with an association of restrictive diet,     physical exercise and drugs. Nevertheless the type of exercise associated to reduction in     cardio-vascular risks is not yet fully defined. Long term effects of such hygienic-diet     programs are of great importance since it is well-known that compliance to such treatment are     of short duration, namely when subjects return in routine life. Metabolic syndrome volunteer     subjects (n=90), aged 50 to 70 yrs will be randomly assigned to 3 groups of investigation.One     group will perform mostly resistance activity, a second mainly endurance activity and the     third one will be composed of subjects not exercising a lot. All subjects will have the same     restrictive diet (500-700 kcal/d) After the initial training (3 weeks), they will return home     with diet and physical program advises (personal compliance). They will be followed for one     year (at 3, 6 and 12 months) Such a design may allow to find out the type of activity and     power that are the best to reduce metabolic syndrome parameters and cardio-vascular risk     factors.      The primary outcome variable is the reduction in abdominal circumference, which is the main     criteria of MS.   "
234565|NCT00917930|"     The purpose of this study is to evaluate the effects of an intensive Cardiac rehabilitation     program on glucose metabolism of non-diabetic coronary artery disease patients.   "
234566|NCT00917943|"     STUDY PURPOSE:      Aim 1. To assess the efficacy of an intervention in preventing or delaying postpartum smoking     resumption among women who stop smoking during pregnancy.      Aim 2. To determine the association of baseline risk assessment variables (dependence,     motivation, self-efficacy, concerns for the fetus, changes in sensory response to tobacco,     depression, weight concerns, and partner/household smoking and support) with time to     resumption.      A two-arm randomized controlled trial will be conducted. Women's risk for resumption will be     assessed at 4 time-points.        1. Between 28 and 34 weeks of pregnancy        2. 6-weeks postpartum        3. 6-months postpartum        4. 12-months postpartum      Women who report not smoking at any of the assessment points will be asked to provide a     saliva sample for analysis of tobacco constituents and a breath sample to assess carbon     monoxide. Bio-behavioral and pregnancy-specific factors will be used to triage women to one     of four levels of stepped-care that includes:        1. One in-person counseling session and at least one telephone session during pregnancy and          from 6 to 11 telephone sessions over the first 9-months postpartum.        2. Risk profiles will be used to match the intervention to each woman's needs.        3. Women randomized to the control arm will receive the booklet, Forever Free for Baby and          Me and usual prenatal and postpartum care.      We are recruiting 400 women for this study from 11 sites in the Durham/ Raleigh/ Chapel Hill     NC area and Fayetteville NC.   "
234567|NCT00917956|"     IBM is the most common acquired muscle disease occurring over the age of 50. The underlying     cause remains unknown and there is currently no effective treatment. Pathological studies     have revealed abnormal collections of proteins in the muscle cells from patients with IBM.     These include proteins called phosphorylated tau (p-tau). A similar process appears to occur     in Alzheimer disease, with accumulations of p-tau developing in brain cells. Lithium     decreases the activity of the GSK, an enzyme that has a key role in the development of p-tau.     Lithium and other GSK inhibitors have been shown to decrease the accumulation of p-tau in     nerve cells in animal models of Alzheimer disease. The proposed research is a pilot study to     see if lithium might be an effective treatment for IBM   "
234568|NCT00917982|"     Vision therapy (VTO) is a group of non-surgical treatment helping patients in 3     subjects;1)increasing the the visual acuity 2)improving the mechanical skills resulting in     increasing the power of extraocular muscles,biocular vision,peripheral vision 3) increasing     the perceptual skills making the brain to percept the colour and visual memory better.In this     study we are going to compare the effect of vision therapy /orthoptic on motor & sensory of     the 3 to 7 years old strabismic patients   "
234569|NCT00917995|"     Specific aim:      To compare patients with colostomies with or without mesh at the primary operation. Primary     endpoint is the incidence of parastomal hernia requiring surgery.      All patients at participating centers scheduled for permanent colostomy, after signing     informed consent and meeting inclusion criteria, will be randomised to formation of a stoma     with or without mesh.      If the inclusion criteria is fulfilled and informed consent is signed, the patient is     randomised preoperatively.   "
234570|NCT00918008|"     The purposes of this study is to evaluate a new genetic-based test which will identify     patients diagnosed with muscle-invasive bladder cancer before their surgery, who might have     specific genes, which will increase their chances of recurrence of cancer after their     surgery.      Some patients who are diagnosed with bladder cancer and have their had bladder removed, will     have a recurrence of cancer sometime after their surgery. This recurrence is usually caused     by tumor cells that originated from the bladder tumor and traveled to other parts of the     body, which is called metastatic cancer. Some patients are more likely than others to have     metastatic disease. This test may help in identifying these patients who might develop     metastases from having these specific genes.   "
234571|NCT00918021|"     The aim of this randomized, double-blind study is to verify the hypothesis that clozapine     monotherapy is as efficient as a combination of clozapine and olanzapine therapy in     treatment-resistant schizophrenia.      A third of schizophrenia patients are non -responders to medications used nowadays. These     patients are usually treated with clozapine, but a large proportion of patients don't recover     sufficiently. Therefore, these patients are treated with combination of two or more drugs to     achieve better treatment results. Until now the scientific evidence has been insufficient to     assess the utility of polypharmacy.      The aim is to study during 2009 with voluntary patients, if there is any benefit of     olanzapine augmentation compared with pure clozapine monotherapy. During the study the     patients are not exposed to any additional intervention. The intervention in this study is     just to reduce the previously used polypharmacy.      Methods: This study lasts for 24 weeks. Participants (30) are randomized in one of two     alternative interventions (A or B) before the study. After 12 weeks the intervention arms     cross over (from A to B and from B to A).      Group B: In addition to clozapine, the participants receive their normal dosage of olanzapine     (=the same as on the hospital ward) for 12 weeks, next the decreasing dosage of olanzapine     for four weeks and subsequently placebo for 8 weeks      Group A: : In addition to clozapine the participants receive the decreasing dosage of     olanzapine for four weeks, next placebo for 8 weeks, after that the increasing dosage of     olanzapine for four weeks and subsequently the normal dosage of olanzapine for 8 weeks      The response for the medical treatment is assessed by Clinical Global Improvement Scale     (CGIS) and Global Assessment of Functioning (GAF) -scale.      The primary outcomes are GAF and modified CGIS during the parallel phase of the study (the     first 12 weeks). The second phase (the last 12 weeks) of the cross-over study is used in the     secondary analysis. The use of additional medication (such as benzodiazepines) is used as a     secondary outcome measure.   "
234572|NCT00918034|"     This is a phase 2 study to evaluate the safety and effectiveness of light-activated     talaporfin sodium in patients with LUTS due to benign prostatic hyperplasia (BPH).   "
234958|NCT00928681|"     study to investigate the safety and efficacy properties of PF-00547659 in patients with     active ulcerative colitis   "
234575|NCT00918073|"     We will conduct a sub-study of An Innovative Telephone Intervention for HIV+ Smokers,     (NCT00502827) conducted by Drs. Gritz, Vidrine, and others. This is a randomized, prospective     trial that will evaluate a cellular phone delivered counseling intervention versus standard     of care for smoking cessation. In our sub-study, we will evaluate rates of progression in     atherosclerosis in HIV/AIDS patients who quit smoking versus those who continue smoking by     measuring carotid intima-media thickness(CIMT) and biomarkers of atherosclerosis at time     point baseline, 1 year, and 3 year. The biomarkers measured include high-sensitivity     Creactive protein, homocysteine, and IL-6. We will also evaluate rates of progression of CIMT     in those who quit smoking versus those who continue smoking, based on race, sex, state of HIV     disease, comorbid diseases, and lipid profile.   "
234576|NCT00918086|"     Tuberculosis bacterium (TB) is a germ that can infect any part of the human body, especially     the lungs. Vitamin D is a hormone present in humans that regulates blood electrolytes such as     calcium and phosphate. There is new information that links vitamin D to the functioning of     our immune system. The purpose of the study is to find out how vitamin D affects the immune     system of patients with TB. We want to find out if correcting low vitamin D levels, in     addition to getting standard therapy for TB, will help the immune system fight off TB     infection more effectively.      The study will be done at the Georgia National Center for Tuberculosis and Lung Diseases     (NCTBLD) in Tbilisi, Republic of Georgia. 220 patients with tuberculosis and 80 family     members or household contacts of patients with tuberculosis will be participating in this     study. TB patients, already receiving standard TB therapy, will be randomly assigned to     either receive the Vitamin D pill or a placebo for a total of sixteen weeks. Neither the     subject nor the investigator will know whether the subject has received the Vitamin D or the     inactive placebo.The subject will orally consume the Vitamin D/placebo tablet 3 times a week     for the 1st 8 weeks (while in hospital) and then once every other week for the last 8 weeks(     during out-patient visits to the hospital).      The main study hypothesis is that Vitamin D supplementation helps patients with tuberculosis,     who are on standard anti TB antibiotic therapy, get better faster.   "
234577|NCT00918099|"     Summary:      Vaginal prolapse is a well-known disease and is observed in approximately 11% of all     postmenopausal women and tending to increase with age. Consequently, many surgical procedures     have been developed in order to ensure sufficient support for the bladder, rectum or vaginal     vault depending on the site of the defect. However, many procedures are associated with a     high recurrence rate up to 40 % even within one to two years after the surgical procedure.      Due to the high recurrence rate new methods include the use of mesh, either biologically or     synthetic. The latter is a permanent implant and therefore theoretically may result in a     long-lasting anatomically correct position of the prolapse.      Although the recurrence rate may be lower using a mesh such surgical procedures may be     associated with adverse events such as erosions of the vaginal mucosa. Others have observed     shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used.     In contrast the recurrence rate is lowered up to 25%.      The above-mentioned advantage of synthetic mesh is however, mostly based on few     non-randomised studies. The investigators therefore find it of importance to evaluate whether     a surgical procedure using a mesh implant is superior to conventional surgical techniques.     The present study is a clinical controlled study where patients with anterior vaginal     prolapse are randomised to either a mesh technique or a standard anterior procedure.      The present study includes only two more visits at the outpatient clinic after the surgical     procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and     faecal leakage and sexual habits.      Any participation in the study is totally voluntary and the patient may at any time withdraw     herself. In any case the patient will receive the investigators' standard treatment.   "
234578|NCT00918112|"     The purpose of this study is to develop a task to measure executive thinking skills that can     be performed in a laboratory setting, but has clear parallels to the thinking demands of real     life situations, and can be administered to patients such as those with Parkinson's who have     difficulty moving.   "
234599|NCT00925717|"     An observational, non-interventional, multi-centre study to provide further information on     the utility of test for a predictive marker by investigating the current prevalence of high     sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.   "
234600|NCT00925730|"     This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream     1% into the blood when applied repeatedly under occlusion (i.e. areas treated wrapped in a     plastic film) over 8 days in patients with moderate to severe atopic eczema.   "
234579|NCT00918125|"     The investigators will examine whether an educational video increases patient knowledge about     heart failure and the risk of sudden cardiac arrest and leads to greater satisfaction with     information provided as compared to usual care. Additionally, the investigators will look at     whether racial concordance (physician and patient being of the same race) improves     satisfaction with the patient's treatment decision and disease knowledge. Our hypothesis is     that a video in which participants are of the same race as the patient will provide better     education and more satisfaction with the treatment decision and may lead to more patients     choosing ICD therapy.   "
234580|NCT00918138|"     The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on     24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with     T2DM inadequately controlled on metformin alone.   "
234581|NCT00918151|"     This study is conducted in Asia. The aim of this observational study is to evaluate current     status of diabetes management, control, and complications in diabetic subjects in Asia.   "
234582|NCT00918164|"     The purpose of this study is to estimate the bioavailability of PF-04457845 tablets relative     to solution and evaluate the effect of food (fasted vs. high fat meal) on the     pharmacokinetics of an oral tablet formulation of PF-04457845   "
234583|NCT00918177|"     The purpose of this study is to evaluate blood level profiles of multiple oral doses of     AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.   "
234584|NCT00918190|"     The purpose of this trial is to study the effects of different combinations of antiemetics on     the incidence of late onset postoperative nausea and vomiting.   "
234585|NCT00918203|"     The purpose of this study is to determine if participants with untreated locally advanced or     metastatic non-small cell lung cancer have a better outcome when treated with olaratumab in     combination with paclitaxel/carboplatin then when treated with paclitaxel/carboplatin alone.   "
234586|NCT00918216|"     RATIONALE: Diagnostic procedures, such as laser spectroscopy, may help find and diagnose     breast cancer.      PURPOSE: This phase I trial is studying laser spectroscopy to see how well it works in     diagnosing breast cancer in women with breast lesions.   "
234629|NCT00926315|"     The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor     cell proliferation and influence gene expression profile of breast cancer samples from     post-menopausal patients.   "
234587|NCT00918229|"     Primary Goal      The study's primary goal is to assess the safety of the BioProtect biodegradable balloon     implant and implantation procedure, in prostate cancer subjects undergoing routine radiation     therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting     adverse events.      Secondary Goal      The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable     balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness     will be assessed in terms of increased distance between anterior rectal wall and prostate and     noticeable reduction of isodose to the rectum.   "
234588|NCT00918242|"     The aim of this prospective study is to investigate the prevalence of coronary artery disease     using computed tomography with family history of premature coronary heart disease   "
234589|NCT00918255|"     This study will investigate how well adalimumab works in people with hidradenitis suppurativa     (HS) in the short and long term.   "
234590|NCT00918268|"     Annual trial for registration influenza vaccine with the strain composition for season     2009/2010.   "
234591|NCT00918281|"     Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection.     Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8     days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels     of 18F uptake on PET.   "
234592|NCT00925626|"     Randomized, single-blind trial in which one group of patients will be operated with a     Mid-Vastus approach of the knee joint and the other group will undergo knee surgery with a     Sub-Vastus approach.   "
234593|NCT00925639|"     Hypoestrogenism, common in menopause, is responsible for systemic and metabolic changes     affecting women's wellness, favoring hot flashes, urogenital atrophy and bone mass loss.     Hormone reposition therapy (HRT) with estrogen or estrogen associated to progesterone is     administered to minimize these effects. Meanwhile, the beneficial effects of HRT are known,     there is still concern about its adverse effects such as thromboembolic and cardiovascular     effects, increased risk of breast and endometrial cancer. Thus, there is an increasing     interest in the development of phytohormonal HRT. The aim of the investigators' study is to     evaluate the effects of concentrated extract of soy on hypercoagulation markers in menopausal     women.   "
234594|NCT00925652|"     If residual breast cancer is found in the breast or lymph node tissue removed after     preoperative chemotherapy, one may be at increased risk of breast cancer recurrence in the     future. The purpose of this research study is to determine if having additional treatment     after preoperative chemotherapy and surgery with bevacizumab and metronomic chemotherapy     would make a difference in reducing the participants chance of breast cancer recurrence     compared to the standard of care, which is observation alone. This study will evaluate the     potential additional benefits from participating in an exercise and dietary intervention     compared to the dietary intervention alone. Bevacizumab is an antibody that is made in the     laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Bevacizumab     works to slow or stop the growth of cells in cancer tumors by decreasing the blood supply to     tumors. Bevacizumab has been approved by the U.S Food and Drug Administration to treat     advanced colorectal, lung and kidney cancers. Metronomic chemotherapy also attacks tumor     blood supply. Standard chemotherapy drugs are used, cyclophosphamide and methotrexate (CM),     but in very small daily doses by mouth, well below the threshold where they can cause people     to feel sick. Previous research studies have shown that women with breast cancer who take     metronomic CM and bevacizumab feel very well, and the combination therapy is active in     reducing their cancer. Participants in this study will also be provided with diet or diet and     exercise counseling over the telephone. Studies have shown that many women who are treated     for breast cancer will gain weight during and after their treatment, and may also experience     fatigue and weakness. Many studies have shown that making changes in diet and increasing     exercise can help prevent weight gain and also may increase energy and decrease other side     effects of chemotherapy and other breast cancer treatments.   "
234595|NCT00925665|"     This study is a comparison of two techniques for endotracheal intubation (Glidescope versus     Macintosh) in patients with odontogenic abscesses.   "
234596|NCT00925678|"     Investigate safety/tolerability after a single dose intranasal administration of DSP-3025     comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients     out of season.   "
234597|NCT00925691|"     The SEPTAL-PM study is aimed to compare the right ventricular apical and right ventricular     septal position of the right ventricular lead in patients implanted with a pacemaker for     conventional anti-bradycardia pacing indications requiring permanent right ventricular pacing     ; the primary endpoint is the evolution of the left ventricular ejection fraction assessed by     contrast echocardiography at 18-months follow-up.   "
234601|NCT00925743|"     This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation,     study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics     (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment,     crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK     of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively).      There are 4 parts to the study:      Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based     on safety.      Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated     Dose (MTD) in an extended cohort of patients.      Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the     pharmacokinetic (PK) of Cabazitaxel.      Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic     (PK) of Cabazitaxel.   "
234602|NCT00925756|"     CCTG 590 is a open-label study to evaluate the impact of therapy intensification with     Maraviroc (MVC) (a CCR5 inhibitor) to a stable suppressive HIV antiretroviral regimen on the     rate of CD4+ T-cell recovery and gene expression profiles. Patients on a stable first-line     HIV regimen with continued viral suppression and sub-optimal CD4+ T-cell counts will be     eligible for this study. Those who are found to be eligible will have MVC (dose-adjusted to     background HIV regimen) added to their current HIV regimen for 24 weeks. After the 24 week     intensification, the MVC will be discontinued, the original antiretroviral regimen will be     continued and the subjects will be followed for an additional 12 weeks.      The investigators hypothesize that MVC will improve the rate of CD4 recovery. This improved     CD4 recovery will be associated with favorable changes in gene expression profiles of genes     involved with CD4 maintenance and circulation.   "
234603|NCT00925769|"     This 2 part study will evaluate the safety and efficacy of a combination of Avastin, Tarceva     and Xeloda (ATX) as second-line treatment in patients with locally advanced and/or metastatic     pancreatic cancer. In the first part of the study, cohorts of patients will receive     escalating doses of combination treatment to determine the maximum tolerated dose. The     recommended dose will be used in the second part of the study to determine the efficacy of     the ATX regime, in terms of its effect on disease progression. The anticipated time on study     treatment is 3-12 months, and the target sample size is <100 individuals.   "
234605|NCT00925795|"     HIV infection is associated with systemic inflammation that is involved in pathogenesis of     atherosclerosis. Treatment of HIV infection may cause lipid profile disturbance and     consequently, atherosclerosis progression. In general, extra virgin olive oil (EVOO) has     beneficial effect on atherosclerosis markers. Our goals are to examine the effect of EVOO on     atherosclerosis markers in HIV-treated patients. A controlled randomized cross-over study     will be performed on 40 participants. They will consume EVOO and ROO (refined olive oil)     during two 20 days intervention periods, interrupted with 14 days wash-out period. Before the     trial and after both intervention periods we will analyze participants' blood for: ESR, white     blood cell count, hsCRP, interleukin-6, oxidized LDL, glutathione peroxidase, superoxide     dismutase, malondialdehyde, triglycerides, total cholesterol, HDL and LDL cholesterol,     fibrinogen, factor VII and von Willebrand factor. We expect an improvement of these     parameters after three weeks of EVOO consumption.   "
234606|NCT00925808|"     This is a prospective study with the following objectives:      Primary Objective:        1. To estimate the prevalence of unsuspected VTE in oncology patients on routine staging CT          scans of the thorax, abdomen and pelvis.           Secondary Objectives:        2. To identify symptoms commonly associated with VTE that are present in cancer patients          undergoing routine staging CT scans with findings of unsuspected VTE.        3. To identify the risk factors and demographic characteristics in outpatient cancer          patients associated with the development of unsuspected VTE.        4. To determine the incidence of recurrence of new VTE in patients with unsuspected VTE at          3 and 6 months of follow-up.   "
234607|NCT00925821|"     Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment     are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is     permitted. After enrollment, patients are to receive four cycles of RAD induction treatment:     a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. If at least a     minimal response is achieved to RAD, they will undergo chemomobilization (cyclophosphamide,     etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan     chemotherapy followed by a first stem cell transplant. If any of the high-risk features (such     as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated LDH, Ig A isotype)     were present at diagnosis, patients will be allocated to a consolidative allogeneic     transplant following dose-reduced conditioning. If no appropriate donor is available, the     patient does not consent or lacks of high-risk features a second autograft following     high-dose melphalan will be delivered. All patients will proceed to lenalidomide maintenance     (one year) following hematopoietic reconstitution.   "
234608|NCT00925834|"     The aim of this randomized controlled pilot study was to answer the following questions:        1. Is it possible to affect the diameter of coronary arteries through a placebo injection,          which is administered intracoronarily together with a standardized verbal suggestion of          coronary vasodilation?        2. Is it possible to affect the diameter of coronary arteries through a pharmacologically          underdosed nitroglycerine injection, which is administered intracoronarily together with          a standardized verbal suggestion of coronary vasodilation?   "
234609|NCT00925847|"     The purpose of the study is to determine whether lithium is safe and effective in the     treatment of ALS   "
234610|NCT00925860|"     The study is aimed to assess the possible benefit of non-positive pressure mechanical support     in front of conventional ventilation in patients admitted to the intensive care unit (ICU)     because of pure hypoxemic respiratory failure.   "
234611|NCT00925873|"     In this study, patients were randomly assigned to either receive fludarabine or not (20     mg/m2/d) in addition to induction chemotherapy, consolidation chemotherapy and the 3     subsequent re-induction courses during maintenance.   "
234612|NCT00925886|"     The purpose of this study is to evaluate neutralization of keratometric astigmatism in     patients with cataract and astigmatism higher than 1 diopter, with phaco surgery and the     implantation of a toric intraocular lens.   "
234613|NCT00925899|"     BACKGROUND:      Patients with advanced cancer often suffer from fatigue and other symptoms and problems such     as insomnia, appetite loss and pain. Problems that may have great consequences for their     quality of life. Several studies suggest that a supplement of the hormone melatonin (MLT) may     have a beneficial effect on these symptoms/problems. This needs further investigation.      AIM:      To investigate if a supplement of melatonin have an effect on a) fatigue (the primary outcome     of the trial), b) the symptoms insomnia, appetite loss, depression and pain, and c) overall     quality of life.      METHODS AND PATIENTS:      The trial takes place in the Department of Palliative Medicine, Bispebjerg Hospital, and 50     patients will participate. The participants have to be 18 years or above, have advanced     cancer, and suffer from quite a bit or very much fatigue.      The study consists of two parts. In part I it is investigated if melatonin has a better     effect than placebo on the outcomes mentioned above. This part is a consecutive, prospective,     double blinded, randomized (MLT vs. placebo), cross-over study where the patients serve as     their own control. In part II the effect of melatonin over time is investigated. Part II is a     consecutive, prospective, open-label study.      The outcomes are assessed with weekly questionnaires (MFI-20 and EORTC QLQ-C15PAL) and a few     daily diary questions.      Melatonin has been used in several studies, and the general conclusion is that it is a safe     substance with few adverse drug reactions.      PERSPECTIVES:      If melatonin has the potential to alleviate fatigue and other symptoms in patients with     advanced cancer and enhance the quality of life of these patients, this will be of benefit to     many future patients. Trials such as this are important both nationally and internationally     to develop an evidence-based palliative medicine.   "
234614|NCT00925912|"     Hemorrhoidectomy can be carried out under several modes of anesthesia. In western country     hemorrhoidectomy usually be performed under general anesthesia, however there may be the     complications resulted from general anesthesia together with associated diseases in advanced     age, caudal or spinal anesthesia has been used as an alternative to general anesthesia (GA)     for hemorrhoid surgery but they all require a trained anesthetist and have numerous known     complications. Since, anesthesiologists are not always available then local anesthesia is an     alternative mode of anesthesia that surgeon can safely carry out by their own. Local     anesthetic produce a loss of sensation and muscle paralysis in a circumscribed area of body     by localized effect on peripheral nerve endings. The local anesthesia is able to provide     fully relaxation of the anal canal which is an ideal setting for various anal surgical     procedures. The results of hemorrhoid surgery under this mode of anesthesia have been     demonstrated in many publications. Local anesthesia is a safe and effective technique while     fewer risks and complications compared with general or spinal anesthesia. In Thailand both     spinal anesthesia and local perianal block have routinely been used for various kinds of     anorectal surgery. However, so far there has no any trial conducting to compare between these     two techniques.   "
234630|NCT00926328|"     The objective of this study is to evaluate the performance of two toothpastes in controlling     established gingivitis and dental plaque in adults.   "
234615|NCT00925925|"     Low birth weight (LBW) status (< 10% for gestational age at birth) is associated with     increased risk for diseases such as type II diabetes mellitus, hypertension, chronic     obstructive pulmonary disease and coronary artery disease in adults, and represents one     example of the fetal onset of adult disease hypothesis. Recent data strongly associates LBW     status with impaired innate and adaptive immunity leading to increased risk for severe     infections during adolescence or early adulthood. Animal studies suggest that the ratio of     certain B lymphocyte subpopulations, the B1a and B1b cells, determines whether deficits in     immunity occur.      This study will determine the ratio of B1b to B1a lymphocyte subpopulations in the cord blood     of infants born LBW in the late preterm to term gestations (> 34 weeks at birth) and compare     those ratios with those of normal birth weight (NBW) controls in a nested case control study     design.      Furthermore, animal studies suggest that the expression patterns of CD5 and CD19 proteins     determines the cellular phenotype of the B lymphocyte, that of a B1a or a B1b cell, and that     the regulatory regions controlling their expression are epigenetically vulnerable. The     investigators will therefore isolate DNA and RNA from both B lymphocyte subpopulations and     determine whether epigenetic changes to the regulatory regions of the genes coding for CD5     and CD19 protein expression occur in LBW lymphocyte subpopulations as compared to the     lymphocytes from NBW infants.      This proposal will be the first human study to examine epigenetic determination of a     maladaptive phenotype following LBW status at birth in a specific cell type leading to a     specific impairment of innate and adaptive immunity.   "
234616|NCT00925938|"     A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to     assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol     Vaginal Priming Insert (MVPI) for Women Requiring Cervical Priming prior to an in-office     hysteroscopy procedure. Each subject will be randomized to receive one vaginal insert. The     study drug will be administered vaginally by a member of the clinical research team (Part I)     or insert herself (Part II) 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.     The internal os of the cervix will be measured at baseline, just prior to the hysteroscopy     and at the follow up visit. The primary outcome measure is change in diameter of the internal     cervical os from baseline (pre-treatment) to just prior to the hysteroscopy procedure     (post-treatment). The hypothesis is that treatment with the MVPI will soften and dilate the     cervix better than placebo.   "
234617|NCT00925951|"     The hypothesis of this study is that the improvement of Numeric Rating Scale (NRS) for Pain     at the end of the study will be greater in the Wet Cupping Treatment group than in the     Waiting Control group.   "
234618|NCT00926172|"     The Chinese Cerebral Aneurysms Survey is a continuing prospective study among middle-aged and     older individuals (35 - 75 years) that aims to determine the prevalence of cerebral     intracranial aneurysms in the general population with MRA at 3.0 Tesla (T).   "
234619|NCT00926185|"     The purpose of this study is to evaluate the efficacy of three different concentrations     (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of     dry eye.   "
234620|NCT00926198|"     Acute pharyngotonsillitis is one of the most common infections encountered by pediatricians.     Most children with acute pharyngotonsillitis have symptoms that can be attributed to viral     infection. However 30-40% of cases is of bacterial etiology.      The purpose of this study is to examine frequency, age distribution, clinical picture and     pathogen distribution in acute pharyngotonsillitis in children in a large urban setting.   "
234621|NCT00926211|"     The objective of this clinical study is to investigate and compare the safety and efficacy of     the Restoration Robotics Computer-Assisted Harvesting System to the manual hair follicle     harvesting method following a nine-month period of post-procedural evaluation.   "
234622|NCT00926224|"     The main objective of the study is to evaluate the diagnostic performance of the XL probe for     estimating degree of liver fibrosis/cirrhosis in obese patients > 28 kg/m² with various liver     diseases in patients with chronic liver disease scheduled for a liver biopsy.   "
234638|NCT00926432|"     Description of the geometrical configuration of the skeleton with regard to gravity line by     patients suffering from spinal disorders that may induce postural troubles   "
234623|NCT00926237|"     One out of every five people experiences tinnitus (a ringing, buzzing, or roaring sound in     the ear) ranging from mild to severe impairment. To date, there are no effective therapies     available that have been shown to decrease tinnitus loudness. The purpose of this study is to     develop a new treatment option for tinnitus using a technique called Repetitive Transcranial     Magnetic Stimulation (rTMS), which will hopefully prove to be an effective means of     alleviating or reducing the symptoms of tinnitus.   "
234624|NCT00926250|"     Sarcopenia, the age-associated loss of skeletal muscle mass and strength, is a frequent     precursor to functional impairment, disability, falls, and loss of independence in the     elderly. The prevalence of sarcopenia is high, with ≥ 45% of the U.S. population aged 60     years or older sarcopenic. Some possible causative factors include a decline in muscle     protein synthesis, inactivity, hormonal changes, pro-inflammatory conditions, and reactive     oxygen species within the muscle mitochondria, which may all be exacerbated by inadequate     nutritional intake. Since dietary protein is targeted to muscle and muscle mass represents     the largest tissue in the body, protein nutrition plays a significant role in muscle     metabolism.      SPECIFIC AIMS The specific aim of this proposed study is to determine the effect of PS-IPC     supplementation on muscle mass, muscle strength, muscle quality, and inflammatory / immune     markers in healthy older adults. Subjects scoring 4 - 10 on the Short-Physical Performance     Battery and aged 60-85 years will consume PS-IPC supplements or placebo three times daily for     12 weeks.      HYPOTHESES        1. Subjects consuming PS-IPC will have a greater increase in muscle mass and muscle          strength compared to a control group consuming a placebo supplement.        2. Subjects consuming PS-IPC will demonstrate a greater increase in the fractional rate of          muscle protein synthesis compared with a placebo control group.        3. Subjects receiving PS-IPC will have a reduction in plasma concentrations of various          inflammatory markers of immune function, compared to subjects consuming the placebo.   "
234625|NCT00926263|"     This study is primarily to evaluate the single dose pharmacokinetics of CP-751,871 and its     effect on QT interval prolongation.   "
234626|NCT00926276|"     The purpose of this study is to evaluate the efficacy of fundoplication in premature infants     with GERD and BPD.   "
234631|NCT00926341|"     Metabolic syndrome, labeled as the world's latest epidemic, is the force behind the global     epidemic of Type 2 Diabetes Mellitus and Cardio Vascular Diseases. This emerging epidemic is     an important public health problem for South Asians in their homeland and worldwide.      Pharmacological therapy is a critical step in the management of patients with metabolic     syndrome. In general, treatment for metabolic syndrome, that targets all or most of the     components of metabolic syndrome is either deficient or non-existent. The study presented     here is the pioneering work in the management of metabolic syndrome, the emerging global     epidemic.   "
234632|NCT00926354|"     Chemotherapy Induced Thrombocytopenia is a common side-effect of bone marrow suppression as a     result of a chemotherapy treatment. AS101 is a tellurium based small compound with     immunomodulating characteristics which attributed to the direct inhibition of the     anti-inflammatory cytokine IL-10. AS101 was previously shown to induce a significant     reduction in thrombocytopenia that accompany cancer therapy with no major toxicity . This     phase II randomized open study will evaluate the efficacy of AS101 for the treatment of     chemotherapy induced thrombocytopenia in patients with various solid tumors.   "
234633|NCT00926367|"     This is a single-blind (blinded expert grader), randomized, half-face study being conducted     at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products,     antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral     side of the face will remain non-treated to serve as a control. Approximately 25-30 male and     female healthy subjects will be randomly assigned to each product   "
234634|NCT00926380|"     The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis     therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will     increase bone mineral density more than either one alone in postmenopausal osteoporotic     women.   "
234635|NCT00926393|"     The purpose of the study is to compare the sedation profile one hour after dose     administration between Seroquel IR and Seroquel XR.   "
234636|NCT00926406|"     One thousand patients with LHD who have no history of exposure to lead will be observed for     18 months. Blood lead level(BLL), biochemical data, hemoglobin, albumin, Cr, high sensitivity     C-reactive protein (HsCRP), and blood cell counts are assessed at baseline. The morbidity and     mortality are recorded in detail. Then, one hundred subjects with high BLL (>20μg/dl) will be     randomly assigned to the study and control groups. For 3-6 months, the 50 patients in the     study group will receive lead-chelation therapy with calcium disodium EDTA weekly until the     BLB falls below BLL< 5 μg/dl, and the 50 control group patients receive weekly placebo for 12     weeks. During the ensuing 18 months, the BLL, biochemical data will be regularly followed up     every 3 months. BLL is measured every 6 months. If BLL of the study group patients increase     >10 μg/dl, the chelation therapy will be performed again until their BLL is <5 μg/dl. The     primary end point is morbidity or mortality during the observation and follow-up period. A     secondary end point is the change in hemoglobin, albumin, Cr and Hs CRP during the follow up     period.   "
234637|NCT00926419|"     This study aims to assess immunogenicity and safety of nd influence of the delivery system     (needle-free injector or syringe with needle) of fractional doses (dose sparing) of two     vaccines (Varicella and Hepatitis A vaccines) in children aged 13 to 30 months.   "
234639|NCT00926445|"     Preterm and critically ill neonates experience many painful manipulations. The aim of the     study is to evaluate the influence of these experiences and maternal deprivation on later     pain behavior. Using Scoring systems, Prechtl general movements, skin conductance, testing     flexor reflex levels with von Frey filaments and measuring salivary cortisol levels the     investigators compare pain behavior of preterm (birth weight (BW) < 1500 grams), term     neonates with need of ventilation (> 48 hours) with healthy neonates at the time of their     first vaccination at the age of 3-4 months. The investigators are also testing flexor     reflexes and skin conductance and general movements in regular intervals during the initial     hospital stay. The investigators hypothesize that pain behavior is different at the age of     3-4 months in children with many early painful experiences.   "
234640|NCT00926458|"     The aim of the study is to evaluate and compare the value of 5 different non-invasive     diagnostic methods in patients with chest pain suspected for coronary artery disease. The     investigators intend to include 200 patients over a 3 year period in the study. The     participants will be recruited from patients referred to coronary angiography at the     institution. Before the angiography the participants will (1) test the effect of sublingual     Nitroglycerin, (2) give their medical history so mathematical models can estimate the     probability of the presence of coronary artery disease, (3) take part in a contrast stress     echocardiography and (4) a 2D-strain stress echocardiography and a myocardial scintigraphy.     Stenosis found at the angiography will be the gold standard.   "
234641|NCT00926471|"     This study will develop and test a treatment aimed at reducing anxiety in social situations     for children and adolescents with autism spectrum disorders.   "
234642|NCT00926484|"     GC Tooth Mousse, a complex containing amorphous calcium phosphate (ACP) and casein     phosphopeptide (CPP), is recommended in dentin hypersensitivity reduction due to its ability     to block opened dentinal tubules. It acts synergistically with fluorine in slowing caries     progression. Whether CPP-ACP can act synergistically with fluorine in the dentin     hypersensitivity treatment is unknown. The aim of this study was to assess the effect of     CPP-ACP combined with fluoride varnish in cervical dentin hypersensitivity treatment.   "
234643|NCT00926497|"     Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic     therapy is crucial for treatment success.      Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf     antibiotic therapy in suspected neonatal early-onset sepsis.   "
234644|NCT00926510|"     To investigate whether young children with isolated expressive language delay benefit from     early intervention with a simple language toolkit and brief instructions provided to their     caregivers.      We hypothesize that children whose families are provided the language toolkit will develop     more words over the subsequent 3 months.   "
234645|NCT00926523|"     We hypothesize that hypoxia-induced pulmonary vascular remodeling is mediated by macrophage     migration inhibitory factor (MIF), that remodeling is in fact the reflection of a chronic     inflammatory process, and that MIF may be a useful biomarker of the severity and progression     of both ILD and PH.   "
234646|NCT00926536|"     Patients will be enrolled based on presence of HCC and eligibility for TACE. They will be     randomized to one of two arms for imaging navigation to the optimal catheter location for     chemotherapy injection to treat the first (possibly sole) tumor target. The two arms will be:     TACE using C-arm CT supplemented by DSA or DSA only (only DSA images will be used for     navigation and tumor vessel tracking). Navigation to subsequent treatment targets in all     patients will be done with fluoroscopy, CACT, and DSA, as is standard of care at Stanford     University Medical Center, and is not part of the study. Vascular complexity, which affects     navigation difficulty and thus the need for imaging, will be assessed separately for use in     data analysis by two radiologists on a four-point scale.   "
234647|NCT00926549|"     The purpose of this study is to analyze macular retinal thickness and macular volume using     the spectral domain - optical coherence tomography (SD-OCT) in normal eyes and in eyes with     various ocular diseases.   "
234648|NCT00926562|"     The investigators intend to find out which contrast agent has less kidney toxicity in renal     impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).   "
234649|NCT00926575|"     Use of an oral topically-active glucocorticoid with limited side effects will control the     gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.   "
234650|NCT00926588|"     Pain is the most common physical symptom in primary care, accounting for an enormous burden     in terms of patient suffering, quality of life, work and social disability, and health care     and societal costs. Pain is particularly prevalent among veterans. Four major barriers to     optimal care include underdetection of pain, inadequate initial treatment, failure to monitor     adherence and symptom response, and failure to adjust treatment in patients not responding or     intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize     Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary     care.   "
234651|NCT00926601|"     Several case report showed that the co-infection of Mycoplasma pneumoniae in patients with     pulmonary tuberculosis. The aim of this study is to elucidate the prevalence and its clinical     significance of co-infection of Mycoplasma pneumonia in patients with newly diagnosed     pulmonary tuberculosis.   "
234652|NCT00926614|"     The aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a     lipid lowering agent (statin) improves sustained virologic response rates in patients who     have previously not responded or relapsed on standard pegylated interferon and ribavirin     therapy.   "
234653|NCT00926627|"     Progressive pulmonary sarcoidosis occurs in up to twenty percent of patients who require     persistent treatment, but available treatment options have shown considerable long-term     toxicity and uncertain or unproven efficacy. In these patients, pulmonary fibrosis and     pulmonary hypertension are common complications which have major prognostic impact.     Endothelin-1 (ET-1) has been demonstrated to play a key role in pulmonary fibrosis and     pulmonary hypertension, and a potential role in pulmonary sarcoidosis. ET-1 is a potent     vasoconstrictor and can promote fibrosis, cell proliferation, and remodeling, and is     pro-inflammatory. Preliminary data have shown the therapeutic potential of the endothelin     receptor antagonist (ERA) bosentan in sarcoidosis associated pulmonary hypertension.      In this light, the therapeutic potential of bosentan as an add-on treatment in progressive     pulmonary sarcoidosis needs to be evaluated.   "
234654|NCT00926640|"     BACKGROUND:        -  The histone deacetylase (HDAC) inhibitors are a novel class of anticancer agent. These          agents lead to the increased acetylation of both histone and non-histone proteins, which          leads to rapid cell death in many tumor models. It is thought that the cell death          observed with this class of agents may be mediated, in part, through the selective          acetylation of histone proteins resulting in increased expression of specific genes.        -  For solid tumors in general, cell death in preclinical models has not translated to          activity in patients. For this reason, studies increasingly have combined chemotherapy          with HDAC inhibitors to achieve additive and potentially synergistic effects on cancer          cells.        -  This protocol will study a continuous infusion of the HDAC inhibitor belinostat in          combination with cisplatin and etoposide for patients with advanced cancer.      OBJECTIVES:        -  To determine a safe and tolerable phase 2 dose for the combination of belinostat with          cisplatin and etoposide.        -  Evaluate molecular markers of HDAC inhibition.      ELIGIBILITY:        -  The protocol will be open to all patients with recurrent or advanced cancer (small-cell          lung cancer and other advanced cancers) for whom standard therapy offers no curative          potential.        -  Age greater than or equal to 18 years        -  ECOG Performance Status 0-2      DESIGN:        -  The study will begin with belinostat 400 mg/m (2)/24h administered by continuous IV          infusion on days 1 and 2, cisplatin at 80 mg/m (2) IV on day 2, and etoposide at 100          mg/m (2) IV daily times 3 on days 2 - 4. Dose escalation of belinostat will follow          according to traditional 3 patient cohorts.        -  Treatment schedule and dose escalation schemata.   "
234655|NCT00926653|"     This study will examine differences in activity of the anterior cingulate cortex, a brain     area involved in emotion and cognitive regulation, between older adults with and without     depression.   "
234656|NCT00926666|"     Studies have suggested a link with effective pain relief and reduced illness and death in     high risk patients. Ultrasound guided nerve blocks have been associated with an increased     success rate and allow visualization of all the anatomical structures and the distribution of     the local anesthetic on injection. The hospital mortality for patients admitted to hospital     from home in the UK in 2006 with a fractured hip is 14.3% (Bottle and Aylin 947-51).      The aim of this clinical trial is to determine the effective dose of local anesthetic to     provide pain relief to patients with a broken hip using ultrasound to guide needle insertion.     The hospital mortality for patients admitted to hospital from home in the UK in 2006 with a     fractured hip was 14.3%. Patients for emergency surgical fixation or replacement of broken     hip will be recruited prior to surgical fixation. All patients recruited to this study will     receive standard anesthesia and surgical fixation of their broken hip.      The trial can be divided into two sequential parts; the results of part A will be an amount     of local anesthetic which will relieve pain of a broken hip in 95% of all patients. Part B     will determine the duration of pain relief provided by the amount of local anaesthetic from     part A and blood levels of local anesthetic.      In parts A and B a standard pain relieving nerve block to numb the nerves supplying the hip     joint will be administered using ultrasound to guide the injection of local anesthetic. The     patient will then be observed for 30 minutes during which time the feeling in the upper leg     and pain scores will be recorded. Patients with ineffective nerve blocks will be given     immediate pain relief and withdrawn from further participation in the study.      In part A the amount of local anesthetic for the next patient will be increased or decreased     if the nerve block is ineffective or effective respectively.      In part B the dose will be the same (calculated from the results of part A). In order to     determine the duration of pain relief pain scores will be recorded hourly for up to 24 hours.     Blood samples will be taken before the pain relieving nerve block and at 5, 10, 20, 30 and 60     minutes afterwards.   "
234657|NCT00926692|"     The aim of this research is to define the human equivalent of mouse B1 cells.   "
234659|NCT00926718|"     Eighty subjects will be recruited from those scheduled for surgery requiring general     anesthesia at St Vincent's Hospital. Subjects must have American Society of Anesthesiologists     (ASA) status of 1 or 2 (be fairly healthy), a BMI between 18-35 (reasonably healthy weight),     and be between the ages of 18 and 75. They will not be eligible if they take certain     medications or are expected to have a difficult intubation.      Subjects will be randomized (assigned by chance) to one of four rocuronium doses of 0, 0.2,     0.4, or 0.6 mg kg-1. All are acceptable clinical doses for performing a laryngoscopy. In the     operating room, routine monitors will be applied, including a Bispectral Index (BIS) sensor     and an M-Entropy sensor. Subjects will receive 0.025 mg kg-1 midazolam (a standard pre-op     dose) and will be put to sleep. Once asleep, the subject will receive a rocuronium dose,     followed by laryngoscopy three minutes later. The anesthesiologist performing the     laryngoscopy will not know what dose of rocuronium the subject received. CVI, entropy, amount     of muscle relaxation, and vital signs will be monitored and recorded throughout the     procedure.      Subjects will receive propofol and remifentanil infusions during the case. These are commonly     used medications for anesthesia. The subjects will also be randomized to two additional     groups. One group will receive a remifentanil infusion of 2ng ml-1 and the other group will     receive a 8ng ml-1 remifentanil infusion. Both doses are acceptable and often used during     standard clinical care. The propofol infusion will be adjusted to keep the BIS number between     45-60. The anesthesiologist will not be able to see the CVI value. The times of certain     intraoperative events, such as intubation and incision, will be recorded. All subjects will     receive a morphine bolus (0.10-0.15 mg/kg) towards the end to reduce post-operative pain, as     per standard clinical care. As the subject wakes up, time to eye opening and orientation will     be recorded. The subject will rate their pain on a numerical pain scale and the quality of     emergence will be assessed.      Upon arrival in the post anesthesia care unit (PACU), subjects will be asked to rate their     pain again using the same pain scale. The pain score will be evaluated every 10 minutes for     half an hour, then every hour until they are discharged from PACU.   "
234660|NCT00926731|"     A study to assess the safety and tolerability of AZD1152 in combination with low dose     cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three     patients to complete a 28 day cycle in the cohort, before the second three patients start     treatment.   "
234661|NCT00926744|"     The purpose of the present study was to clarify the effects of increase in physical activity     on incidence and surrogate marker of cardiovascular diseases. The working hypothesis of the     present study was that the physical activity to satisfy the Japanese guideline of Ministry of     Health, Labour and Welfare is effective for the primary prevention of the lifestyle-related     disease.   "
234662|NCT00926757|"     Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is     common in cancer patients who have chronic HBV infection. Lymphoma patients who had previous     infected by HBV but negative for HBsAg have a the risk of HBV reactivation during     chemotherapy, but prophylactic antiviral treatment is not a routine by current American     Association for the Study of Liver Diseases (AASLD) guideline. Prophylactic entecavir might     reduce the risk of HBV reactivation in such patients.   "
234663|NCT00926770|"     Preterm infants often need peripheral artery catheters for invasive blood pressure recording     and to facilitate blood sampling. Near infrared spectroscopy is a method to evaluate cerebral     oxygenation and as well as cerebral blood flow. Sampling procedures with identical sampling     volumes are performed at a short (40 seconds) and a long (70 seconds) time intervall while     changes of cerebral oxygenation are measured. The investigators hypothesise that slower     sampling decrease changes in cerebral blood flow.   "
234685|NCT00927069|"     This study will provide data on additional therapeutic benefits in administering Adalimumab     in patients with plaque psoriasis that showed an unsatisfactory response after at least 3     months of treatment with etanercept.   "
234664|NCT00926783|"     This study will be a multicenter, open, prospective, randomized trial. Patients with either     paroxysmal or persistent atrial fibrillation will be considered for the study. (For US, only     paroxysmal atrial fibrillation will be considered.) Eligible subjects will be randomized into     one of two arms in the study: (1) targeted CFAE ablation or (2) generalized CFAE ablation.     Both techniques will then be followed by PVAI (pulmonary vein antral isolation) as part of a     hybrid ablation strategy. The nature of the ablation procedures does not allow physicians to     be blinded to the randomization.   "
234665|NCT00926796|"     The purpose of this study is to learn how to better treat gonorrhea infections. Gonorrhea is     a sexually transmitted disease (STD) that is usually cured with a single antibiotic. However,     some gonorrhea is not cured with a single antibiotic. The study will look at how well     treating gonorrhea with 2 antibiotics works. Participants will be assigned to 1 of 2     treatment groups each receiving a combination of 2 antibiotics. Sites in the United States     will recruit 500 male and female participants. Participants must be 15 to 60 years old, in     good health and identified in participating sexually transmitted disease clinics as having     uncomplicated cervical or urethral gonorrhea. Procedures include collection of current     symptoms, medical and sexual history, sexual orientation, vital signs, height, weight,     cervical/urethral cultures and clinical examinations. Volunteers will be involved for about     17 days.   "
234666|NCT00926809|"     This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing     of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic     lesions and is a multicenter, randomized, double blind, and placebo controlled trial.   "
234667|NCT00926835|"     The primary purpose of this study is to investigate the effectiveness of antidepressants on     the treatments for non-psychotic major depressive disorder (MDD) in Korea. The study divides     MDD patients into 3 level groups according to their past histories to treatments and compares     the effectiveness of various treatment regimens at each level.      The treatment level groups are: 1) patients who have never been treated with appropriate     medications for their current depressive symptoms before, 2) who received an appropriate SSRI     (Selective Serotonin Reuptake Inhibitor) once but did not respond to it, 3) who received two     types of SSRI antidepressant treatments without much effects in reducing their depressive     symptoms.      The first level group will be treated with a single SSRI antidepressant treatment. The second     and third level groups, who received SSRI treatment before, will be treated with alternative     SSRI antidepressants (switching), combined multiple SSRI treatments (antidepressant     combination), or SSRI treatments combined with mood stabilizer or anti-psychotics     (augmentation). This study does not use placebos. Patients will visit 5 times for 6 weeks at     each level for treatments. Patients will be evaluated for the severity of depressive     symptoms, functional level, and side effects at each visit. Afterwards, the investigations     will combine to monitor the patients depressive symptoms in every 3 months for the next 24     months. 18 nationwide university hospitals will participate in this study. This multi-site,     prospective, and naturalistic study for patients with depression in Korea is a main project     of 'Clinical Research Center for Depression' funded by the Ministry for Health, Welfare, and     Family Affairs (MIHWAF) in Korea for a highly-qualified research achievement.   "
234668|NCT00926848|"     The objective of the proposed study, using an experimental, two-group (n = 30 couples in each     group) repeated measures design, will be to pilot test the effects of the PaTH Intervention     versus a usual care group in improving the following outcomes: a) physical activity and     healthy eating behaviors, b) functional capacity; c) quality of life (physical,     psychological, and relational); and d) risk level for heart disease. The primary variables     will be change in outcomes from baseline to 3 and 6 month time points in both the coronary     artery bypass graft (CABG) patient and his/her partner.   "
234669|NCT00926861|"     Choroidal neovascularisation in age related macular degeneration is one of the major causes     of legal blindness in the western world existing in two major occurences, the dry and the wet     form.The etiology of age related macular degeneration is yet unknown. Genetic factors,     oxidative stress, Ischaemia, and aging of the retinal pigment epithelium are discussed as     etiologic factors. The risk of rapid vision loss is much higher in wet AMD, a dry form may     transform to a wet form. From a prior study the investigators know that the posterior hyaloid     is significantly more frequent attached in wet AMD. This study is conducted to examine     whether the attached posterior hyaloid is a risk factor to develop wet AMD in dry AMD cases.   "
234670|NCT00926874|"     A pilot, prospective, comparative study. To include both male and female patients who have     presented an ischaemic stroke (full stroke or TIA) or an ACS, 5 to 30 days prior to     inclusion.      The proposed study aims to investigate and analyse the differences in functional and     structural arterial properties between the patients who presented an ischaemic stroke and     those who presented ACS. The hypothesis is that the patients in both groups will present     differences partly in terms of their traditional cardiovascular risk factors, but also in     terms of their arterial properties. All of the confounding factors studied (cardiovascular     risk factors, treatments) will be taken into account in order to explain the differences in     the arterial properties found between the two groups. Furthermore, the prevalence of signs     and symptoms in the two populations will be studied.   "
234671|NCT00926887|"     The goal of the clinical study was to see if applying low level laser light therapy to the     breasts during breast implant surgery could lessen pain experienced by 24 hours after the     surgery.   "
234672|NCT00926900|"     The aim of this project is to explore whether the extinction of cue-reactivity following a     cue-exposure based intervention in volunteers with an alcohol dependence is facilitated by     drugs that increase NMDA-receptor function.      It is hypothesised that targeted treatment with D-Cycloserine prior to each extinction     training session enhances the effects on cue-reactivity.      Further, a significant correlation between the reduction of cue-reactivity and both reduced     craving and relapse probability is expected.   "
234686|NCT00927082|"     This study is a long-term post-treatment follow-up to study WV19432, which evaluated the     efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B     (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to     enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the     target sample size is 100-500 individuals.   "
234673|NCT00926913|"     With the aging of the population, the prevalence of age-related macular degeneration (AMD)     eye disease has resulted in a large number of people suffering from central vision loss. In     fact, the most prevalent cause of blindness among veterans is AMD. Since the number of     elderly veterans is expected to double in the next 10 years, loss of vision due to AMD is     also expected to proportionally and considerably escalate. People with impaired vision have     difficulty with daily activities, such as, reading, driving, and recognizing faces. The goal     of the research project is to provide information on factors that contribute to visual     impairment. This knowledge is necessary for the development of innovative approaches that     will optimize the benefit of vision rehabilitation techniques, aimed at improving vision,     thus allowing our veterans to maintain function and productivity. The findings from the     proposed research will benefit our veterans and all aging people.   "
234674|NCT00926926|"     This study explores the effect of oxybutynin topical gel on gastric emptying   "
234675|NCT00926939|"     The purpose of the study is to evaluate a sustainable and broadly accessible treatment     delivery model (Motiv8) for smoking cessation based on abstinence-reinforcement.   "
234676|NCT00926952|"     Actinic keratoses on the face are often numerous and widespread. The application of     Methylaminolevulinate (MAL) on individual lesions followed by the application of a plastic     film on each lesion is difficult and takes time for subjects with many actinic keratoses. The     waiting period of 3 hours between MAL cream application and red light exposure is also long     for patients. The goal of this study is to evaluate the safety and efficacy of photodynamic     therapy (PDT) with MAL with a shorter cream application time (90 minutes) and when MAL is     applied on the entire face without the plastic film.   "
234677|NCT00926965|"     Previous researchers indicate that impaired cognitive flexibility was the primary factor     distinguishing patients with from those without tardive dyskinesia (TD)1, and cognitive     dysfunction correlates positively with the severity of TD2. Longitudinal data raised the     possibility that the association between cognitive dysfunction and TD may reflect not organic     vulnerability to but rather a state marker for this movement disorder as tardive dementia3.     Atypical antipsychotic had been reported to alleviate the severity of TD4 and improved     neurocognitive function separately5. But no researchers ever investigated the correlation of     the two effects simultaneously. This randomized, single-blind and controlled study compared     the effect of atypical antipsychotic on TD, neurocognitive function and associated factors     for these changes.   "
234691|NCT00927147|"     The purpose of the study is to investigate efficacy and safety boron neutron capture therapy     (BNCT) administered in combination with cetuximab in the treatment of head and neck cancer     that has recurred locally following conventional cancer treatment (surgery and radiation     therapy). Boron neutron capture therapy is a special form of radiation therapy, which is     based on interaction between boron atoms taken up by the cancerous tissue and neutron     irradiation. The boron atoms, located within cancer cells, may capture low-energy neutrons     obtained from a nuclear accelerator, which results in splitting up (fission) of the boron     atoms, and a high radiation effect within the tumor. Cetuximab is an antibody directed     against certain proteins found on cancer cell surface (epidermal growth factor receptors).     When administered immediately after BNCT, cetuximab may or may not improve treatment     efficacy.   "
234678|NCT00926978|"     This research study is to compare the radiopharmacokinetics of I-124 to the     radiopharmacokinetics of I-131 in patients who have well-differentiated thyroid cancer after     recombinant human thyroid-stimulating hormone (rhTSH) injection. I-131 is routinely used for     imaging and dosimetry for patients with well-differentiated thyroid cancer. In this study,     I-124 is administered orally in capsular form, and the radiopharmacokinetics of I-124 is     compared with I-131. I-124 is another isotope of iodine, which is cyclotron-produced. I-124     has multiple advantages:        -  Ideal Half-Life (4.2 days) for delayed imaging.        -  High resolution tomographic imaging.        -  Feasibility of quantitating lesion uptake.        -  Potential of dosimetry for the planning of radioiodine therapy.      Voluntary patients will have I-124 dosimetry performed in addition to the I-131 dosimetry,     which is planned as part of routine clinical care. I-124 dosimetry is composed of four parts:     (1) two extra doses of injections of rhTSH, (2) the administration of I-124, (3) PET imaging,     and (4) drawing blood samples.      Patients will receive two additional injections of rhTSH. This is similar to the procedure     for I-131 dosimetry. Second, they will receive I-124. I-124 is similar to I-131 except I-124     decays in a different way to emit a positron so that the PET scanner can be used for imaging.     I-124 is given in the form of one or several capsules, which are taken by mouth. This is also     similar to I-131. Third, PET/CT imaging is done for approximately 30 minutes to one hour on     five consecutive days. Radiation from PET/CT scan is far less than what they receive from a     diagnostic CT scan. For the fourth part, a technologist will draw about 5 cc from the forearm     on each of the five consecutive days. This is also similar to I-131.      Initially, all patients will be randomized to one of two study groups. The first group will     have the I-131 dosimetry performed first followed by the I-124 dosimetry, and the second     group will have the I-124 dosimetry performed first followed by the I-131 dosimetry.      The risk of this study is considered very low, and the potential benefits to the patient are     considered very high.   "
234679|NCT00926991|"     This is a prospective, observational trial of 50 patients who have multiple, severe rib     fractures following trauma. The investigators will follow their hospital stay for outcomes     (infections, length of stay and medical care) as well as their early post-hospital course.   "
234680|NCT00927004|"     This study aims to better understand the way in which painful osteoarthritis affects     different people and whether an anti-inflammatory medication such as Arcoxia (etoricoxib) can     help to modify this pain. The study will use questionnaires and tests of pain sensitivity to     identify arthritis sufferers with more widespread, nerve-type pain and then to investigate     whether a daily dose of Arcoxia is more effective than a placebo pill in reducing these     symptoms and improving functional movements. The study will also be comparing the same test     results of a small group of subjects without knee pain.   "
234681|NCT00927017|"     The hypothesis is that liquorice lowers plasma potassium. This study aims to elucidate the     dose-response of this effect with two doses of liquorice (66 grams or 102 grams) per day for     two weeks.   "
234682|NCT00927030|"     The purpose of this study is to determine if liquid supplemental melatonin is an effective     treatment for children with autism who have sleep problems related to insomnia (difficulty     falling asleep).   "
234683|NCT00927043|"     This is an epidemiological, prospective, multicenter study designed to identify the     pre-treatment clinical, molecular and genetic prognostic factors associated with progression     free survival in patients naïve to renal cell carcinoma (RCC) treatment.   "
234684|NCT00927056|"     Overall Objective: To evaluate pain and functional status of patients undergoing surgical     correction for lumbar herniated disc, pre- and post-surgery, using subjective (VAS, Oswestry,     PSQI, Patient Expectation), as well as, objective measures of physical activity (triaxial     accelerometry).      Design and Methods: Two groups of subjects will be examined; 1) patients diagnosed with     lumbar herniated disc undergoing minimally invasive microdiscectomy (MD), and 2) patients     diagnosed with lumbar herniated disc undergoing open microlumbar discectomy (OD).      Subjects who agree to participate, will be assessed (assessments listed below) after the     diagnosis and prior to surgery. The subject will then be assessed postop and they will     continue with follow-up after surgery with a visit at 3 weeks postop. Both methods of     discectomy will be discussed with the subject. Once the subject has consented to participate     (and prior to surgery), subjects will be randomized with a 50/50 chance of being placed in     the MD or OD groups. Subjects will be distributed into the MD group and the OD group using a     block randomization method. The study will be single blinded. A longitudinal, within group,     comparison will be made to assess the change in the measured parameters. Data involving the     MD and OD groups will be accumulated in a cross-sectional fashion.      Subjects will be recruited from the referrals to the practices of the Orthopedic and     Neurosurgeon Spine Surgeons at the Health Sciences Centre. This encompasses the majority of     new and currently managed cases in the Manitoba and Northwestern Ontario.      Subjects will be between the ages of 18 and 90. Male and female subjects will be recruited     into the study. All patients will clinically demonstrate unilateral lower extremity pain in     greater proportion to low back pain symptoms if present. Imaging (CT) will document single     level lumbar herniated nucleus pulposis. Exclusion criteria will be cauda equina syndrome,     progressive neurologic deficit, bilateral lower extremity symptoms, low back pain more than     leg pain, the existence of significant co-morbidity (e.g. cardiac condition, disease, etc.)     of any form, and any other physical limitations (musculoskeletal injury). Subjects     participating will be required to speak and read English.   "
234687|NCT00927095|"     The purpose of this study is to compare a low dose oral contraceptive (OC) given continuously     (every day for three months) with the same low dose oral contraceptive given in an     interrupted regimen (one week of inactive placebo pills each month) and with continuous     placebo (inactive placebo given every day for three months). The primary hypothesis is that     continuous OC will be significantly more effective in reducing premenstrual symptoms compared     with either the interrupted OC or continuous placebo.   "
234688|NCT00927108|"     To study the success of Oligodendrocyte progenitor cell culture project in Rajavithi Hospital     to identify an unlimited clone human neuronal progenitor stem cells from the human brain in     the Biomolecular Research Center. This study aims to produce the reproductive clone of     neuronal development protocols and advance projects. Neuronal cells such as pyramidal cells,     oligodendrocyte, and dopaminergic neuron differentiation protocol/projects for treatment of     Alzheimer's disease, Multiple sclerosis, and Parkinson's disease respectively in next phase     of clinical trials.   "
234689|NCT00927121|"     There are many treatments for chronic tinnitus that have been claimed, with varying degrees     of statistical reliability. None of those treatments can eradicate the tinnitus completely.     Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there     is still a need of new treatments that can reduce considerably the tinnitus symptoms and     improve the QOL of subjects.      Trial objectives:        -  The aim of this trial is the improvement of the QOL (quality of live) by reducing the          Tinnitus- Symptoms of the patient.        -  To confirm the efficacy and safety of the coordinated reset technology.      These objectives will be assessed:        -  By subjective and objective measurements of the Tinnitus symptoms, loudness and          annoyance.   "
234690|NCT00927134|"     The aim of the study is to evaluate the side effects and risks after infusion of retroviral     gene corrected autologous CD34+ cells of the peripheral blood of chemotherapy conditioned     (busulphan) children with chronic granulomatous disease (CGD). Also gene corrected and     functional active granulocytes in the peripheral blood and the engraftment in the bone marrow     of the patients will be monitored an documented.   "
234692|NCT00927160|"     The purpose of this study is to determine if a new model of care, the Mobile Acute Care of     the Elderly Unit is beneficial in improving patient outcomes for elderly patients admitted to     the hospital.   "
234693|NCT00927173|"     The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS,     (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in     subjects with Major Depressive Disorder that have been previously unsuccessfully treated with     antidepressant medications.   "
234694|NCT00927186|"     The purpose of this study is to investigate how teriparatide or zoledronic acid affects the     bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone     biopsy sample taken from the iliac crest (upper part of the pelvis). After completing 12     months of treatment all participants are eligible to participate in an additional 12-month     open label extension.   "
234695|NCT00927199|"     The purpose of this study is to assess the efficacy of high-oleic canola oil and a high-oleic     canola/flaxseed oil blend as compared to a typical Western diet on plasma lipids, fatty acid     profiles, and risk factors associated with cardiovascular disease in hypercholesterolemic     patients. Furthermore, the metabolism of dietary oleic acid and alpha-linolenic acid     contained in high-oleic canola oil and flaxseed oil will be investigated.   "
234696|NCT00927212|"     Atopic Dermatitis is a chronic non contagious disease that causes itchy, inflamed skin. The     purpose of this study is to evaluate the safety and efficacy of topical AS101 ointment for     the treatment of Atopic dermatitis.   "
234697|NCT00927225|"     Local infiltration analgesia is effective in total knee arthroplasty for postoperative pain     management, but the efficacy of subcutaneous wound infiltration has not been evaluated. This     study aims at evaluating the efficacy of subcutaneous wound infiltration in total knee     arthroplasty in 16 patients undergoing bilateral knee arthroplasty.   "
234698|NCT00927238|"     The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients     with single-level degenerative disc disease compared to other devices approved by the FDA for     the same or similar indications.   "
234699|NCT00927251|"     This study is designed to show that a new lead, which paces the left bottom chamber (left     ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown     to potentially improve heart failure symptoms. The shape and size of this new lead may make     it a good choice for patients or physicians.   "
234700|NCT00927264|"     Environmental tobacco smoke (ETS0, also known as secondhand smoke, is the combination of     smoke given off by the burning end of a tobacco product and the smoke exhaled by the smoker.     Children exposed to ETS are at an increased risk of sudden infant death syndrome (SIDS), ear     infections, colds, pneumonia, bronchitis and more severe asthma. ETS can also slow the growth     of children's lungs and can cause them to cough, wheeze and fell breathless. The purpose of     this study is to determine the effectiveness of a motivational interviewing-based program in     reducing ETS exposure and improving lung health among children who are enrolled in a Head     Start program and whose households include a smoker.   "
234701|NCT00927277|"     The purpose of this study is to determine whether low level laser therapy can help the     recovery process for the procedure of liposuction of the thighs, hips and stomach.   "
234702|NCT00927290|"     The purpose of this study is to test whether the correction of insulin resistance with     pioglitazone, will improve the response to antiviral treatment.   "
234703|NCT00927303|"     Retinal thickness measurement is one of the most important examinations in the follow up of     exudative age-related macular degeneration. Prior studies have shown that there are a series     of algorithm line failures in OCT examinations. This study is conducted to compare the     quality of the examinations of to different spectral domain OCT machines concerning the     positioning of algorithm lines. Furthermore the reproducibility of the examinations id     tested, both machines provide different techniques to guarantee that in repeated examinations     the same location is examined.   "
234704|NCT00927316|"     This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli     83972) protect against symptomatic urinary tract infections in individuals with bladder     emptying dysfunctions and prone to recurrent infection episodes? The study is performed using     a double-blind randomized study protocol with a cross-over, with re-inoculations being     patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had     bacteriuria or placebo-periods < 12 months will be subjected to additional patient blinded     inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients     are unaware of urine culture results.   "
234705|NCT00927329|"     The purpose of this study is to serve as a pilot safety study for nasal allergen challenges.   "
234706|NCT00927342|"     Following lung surgery air may continue to leak from the surface of the lung. Chest drains     are placed to allow this air to be removed safely and prevent the lung from collapsing.     Drains need to remain until the air leak from the lung has ceased.      Air which continues to leak results in longer chest drainage times which cause increased     discomfort and immobility for patients. These patients are at risk of secondary complications     such as infection. Longer hospital stays and increased costs ensue. A randomised controlled     trial (RCT) conducted at The Royal Brompton Hospital has shown clear benefits in the     management of difficult air leak with the use of BioGlue. BioGlue is a surgical sealant     applied to the surface of the lung at the time of surgery.      BioGlue is of bovine origin. Concerns exist regarding the potential risk of transmission of     blood borne diseases with bovine derived medical products. Should a surgical adhesive without     these potential risks prove as effective as BioGlue then its use could be commended.      The Vivostat System is a medical system that derives a sealant from the patient's own blood.     A small study has shown that it may also be of benefit in the management of difficult air     leaks. The principal aim of our RCT is to compare the duration of air leak, length of chest     drainage and hospital stay associated with BioGlue to that of Vivostat.   "
234707|NCT00927355|"     We will prospectively study 2 groups of diabetic patients treated with pioglitazone or     placebo for 26 weeks. Bone marrow aspirates will be obtained from these patients at baseline     and after 26 weeks of treatment, and hBMCs will be isolated from these bone marrow     aspirations. The ability of hBMCs to differentiate into osteoblast and adipocytes lineages     will be compared before and after treatment with pioglitazone and compared to placebo. In     parallel, clinical markers of bone formation and resorption as well as bone mineral density     will be assessed before and after 26 weeks of treatment. Primary endpoint for this study will     be detection of change in number of osteoblasts or adipocytes from cultured hBMCs between     study groups and within each group.   "
234708|NCT00927368|"     This is a randomized study which will compare three femoral nerve catheter insertion     techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided     femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2:     ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating     catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.   "
234709|NCT00927381|"     Retrospective observational review of severe envenomation treatment with CroFab   "
234710|NCT00927394|"     The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the     combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy     in Type II Diabetic patients with Stage II hypertension.   "
234711|NCT00927407|"     In this study, 24 adult patients with head lice will be treated with a topical malathion head     lice treatment; 12 patients will be treated with a novel product, Malathion Gel, 0.5%, and     other 12 patients will be treated with Ovide Lotion 0.5% marketed by Taro Pharmaceuticals     USA, Inc. The primary objective of this study is to compare the blood level exposure of     Malathion 0.5% Gel to that of the OVIDE Lotion 0.5%.   "
234712|NCT00927420|"     The purpose of this study is to estimate adherence to treatment in bipolar patients, to     characterize patients based on adherence degree and to describe the variables linked to poor     adherence to treatment in real-life practice.   "
234713|NCT00927433|"     Background: Result from an earlier study I carried out in the late 1990 showed that cancer     patients were overall well informed about diagnoses, prognoses, symptoms, treatment,     side-effects of treatment e.g. pain, nausea and vomiting and hair loss. Their knowledge about     fatigue as a side -effect to cancer and cancer treatment was however different. Patients had     minimal knowledge about fatigue and they were not prepared for this side-effect and as a     result of this they did not know how to handle fatigue and fatigue was seen as a very     frightening experience.      As a result of the findings I wanted to carry out an intervention study, where the aims were     to develop an educational programme about fatigue and to evaluate the effect of the     programme.      Purpose: The purpose of the project is to develop and describe a structured educational     programme. The structured educational programme will serve as the intervention. The purpose     is also to evaluate whether or not the structured educational programme increase the cancer     patients knowledge about cancer related fatigue and to find out if increased knowledge about     cancer related fatigue ease the experience of cancer related fatigue.      Another purpose of the study is to investigate the connection between fatigue and other     symptoms and to find out how other symptoms influence the patients experience of fatigue.      The study will consist of 3 stages.        -  Development of structured educational programme        -  Implementation of structured educational programme        -  Evaluation of the effect of the structured educational programme      Materials and methods: The study is a randomised experimental design. An intervention group     and a control group, each consisting of 100 Breast Cancer patients (Stadium I or II)     receiving chemotherapy or/and radiation therapy after surgery are included in the study. On a     NR-scale (0-10) the patients had a fatigue score of 2,5 or more to be included in the study.      The intervention is an educational package of 120 minutes x 3 over three weeks. The     intervention is given in groups of 10 patients. Both groups are responding to questionnaires     just before the intervention, just after the intervention and three months after finishing     the intervention. The educational package consisted of basic knowledge about fatigue, and     strategies or techniques for coping with fatigue.   "
234714|NCT00927446|"     Patients with head and neck cancer frequently develop synchronous or metachronous esophageal     malignancies. Previous studies have demonstrated the efficacy of endoscopic screening for     esophageal cancer in head and neck cancer patients. The Narrow Band Imaging (NBI) system, an     optical technology that enhances the visualization of superficial vascular network, may be     superior to the conventional white light endoscopy for the detection of neoplastic lesions.     However, whether the application of NBI improves the detection results have not been     critically evaluated.      This study aims to investigate the diagnostic value of the NBI system in the endoscopic     screening for esophageal neoplastic lesions in patients with head and neck cancer.   "
234715|NCT00927459|"     This study is a Phase 1, single-center, placebo-controlled, single-blind, first-in-human,     single-ascending dose study in male and female subjects with high cholesterol. A maximum of     32 subjects is planned for enrollment in this study.   "
234716|NCT00927472|"     In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for     head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an     established head lice treatment. The new formulation has been evaluated in 2 previous studies     of patients 2 years of age and older.   "
234717|NCT00927485|"     Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the     formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually,     all patients with FAP will develop colorectal cancer on average by the 5th decade of life if     prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer     surveillance of the remaining colorectum or ileum.      Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which     selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2     (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the     rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with     significant comorbidity including renal and gastric toxicity and increased risk of vascular     events. Therefore, identification of a chemopreventive agent that would have similar efficacy     but less toxicity would enhance our ability to treat these patients. Therefore the following     specific aim has been proposed:To determine in a randomized, double-blinded,     placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal     adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients     with FAP.   "
234718|NCT00927498|"     The main objective of this study is to compare conventional chemotherapy: daunorubicin and     the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg     in divided doses.   "
234719|NCT00927511|"     In post-menopausal metastatic hormone-responsive breast cancer women.      This study is a two arm randomized trial to evaluate the effectiveness of dose-titration     regimen of fulvestrant compared with the approved dosing regimen. Patients will be randomized     to one of the following treatment arms:      Arm A: Fulvestrant 500 mg days 0, 14, 28, then 250 mg every 2 weeks for 5 administrations,     then 250 mg every 28 days, until progression or unacceptable toxicity Arm B: Fulvestrant 250     mg every 28 days until progression or unacceptable toxicity   "
234733|NCT00927693|"     Early Identification of Subclinical Atherosclerosis by Noninvasive Imaging Research (EISNER)     is a multi-study research program being conducted at Cedars-Sinai Medical Center.      The principal objective of this randomized trial (referred to as Study 1) is to assess     whether coronary artery calcium (CAC) scanning provides clinical benefit thus improving     patient outcomes in asymptomatic subjects with intermediate coronary artery disease (CAD)     risk. Additionally, the study is designed to assess the value of combining the CAC scan with     the Framingham risk score (FRS) and measurements of serum or plasma biomarkers to predict     outcomes.   "
234959|NCT00928694|"     This study will determine definitive bioequivalence of the United States (U.S.) and United     Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy     adult subjects.   "
234720|NCT00927524|"     Intensive control of Type 1 Diabetes is critical in prevention of long term complications.     Unfortunately, there is a three-fold increase in hypoglycemia with intensive control.     Hypoglycemia is often the major limiting factor in achieving good control. Insulin treatment     of diabetes is composed of some form of short acting insulin regimen in order to provide     control of blood glucose excursions that are the result of glucose intake as well as a basal     insulin regimen either in a continuous administration (as in continuous subcutaneous insulin     infusion-pump therapy), once a day injection (insulin Glargine), twice a day (ultralente or     NPH or lente insulin) or a premixed version that is combined with the short acting insulin     (70/30 or 75/25). Often low blood sugars are the result of less physiologically absorbed     insulins whose peak of action is earlier or later than the peak absorption of glucose from a     meal.      Apidra (glulisine insulin) is a new short acting insulin analogue whose peak and duration of     action are ideal in that it may be administered more appropriately prior to and even after a     meal with evidence of good control of blood glucose excursions from a meal. The purpose of     this study is to compare the effect of Apidra upon meal related blood glucose profile as     compared to those treated with 70/30 insulin in patients with Type 1 Diabetes. The     investigators also will study healthy volunteers as controls who will not be treated with     insulin but will be evaluated for mealtime absorption and blood glucose profile during     similar meal intake. The investigators will use a stable isotope tritiated glucose.   "
234721|NCT00927537|"     The efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed     over 3-4 months   "
234722|NCT00927550|"     The principal clinical question is whether lithium is effective in reducing the risk of     suicidal behaviour in subjects with treatment-resistant depression and suicide risk.     Additionally aims of the study are: (a) to assess whether lithium is effective in improving     depressive symptomatology in subjects with treatment-resistant depression and suicide risk;     (b) to assess the tolerability profile of lithium.   "
234723|NCT00927563|"     The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in     pathological gambling.   "
234724|NCT00927576|"     The investigators evaluated whether it was possible to improve the measurement of memory,     attention, and executive function in patients who have suffered traumatic brain injury     through the use of computer-based testing.      Note: the original design of the study was altered due to failure to recruit sufficient     numbers of patients who were willing to undergo prolonged cognitive training.   "
234725|NCT00927589|"     This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect     of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin     pharmacokinetics in patients with HER2-positive metastatic or locally advanced inoperable     cancer.      The QT interval is a measure of time between the start of the Q wave and the end of the T     wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated     using Fridericia's correction; the QTcB interval is the QT interval as calculated using     Bazett's correction.   "
234726|NCT00927602|"     Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous     thromboembolism in high risk medical patients. A relevant proportion of medical patients have     moderate to severe renal insufficiency, which is an independent risk factor for bleeding.     This risk may be further increased when low molecular weight heparin or fondaparinux are     administered in patients with severe renal insufficiency, defined by a creatinine clearance     of lower than 30 mL/min. No clear indications are available to reduce such risk in patients     who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently     approved for the prevention of venous thromboembolism in the specific population of patients     with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization).     However, there are to our knowledge no clinical studies that have assessed the safety and     efficacy of this reduced dosage in medical patients.   "
234727|NCT00927615|"     The primary objective of this study is to investigate whether intracoronary bolus     administration of abciximab is superior to intravenous bolus administration in improving     myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing     primary percutaneous coronary intervention.   "
234728|NCT00927628|"     The purpose of this investigation was to determine the incidence and the factors that cause a     reopening of a macular hole (MH) after a surgical closure.   "
234729|NCT00927641|"     The objective of this study is to demonstrate the multiple-dose efficacy and safety of     HKT-500 for the treatment of ankle sprain.   "
234730|NCT00927654|"     In this study effects of the intra operative, prophylactic inhalation of Iloprost (Ventavis)     before and during extracorporal circulation on perioperative morbidity and outcome in high     risk cardiac surgical patients is investigated in comparison to placebo.   "
234731|NCT00927667|"     The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little     blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging     session. No study medication is given.   "
234732|NCT00927680|"     Colorectal cancer (CRC) is the second leading cause of cancer in Puerto Rico (PR) accounting     for approximately 1,500 individuals annually, which represent 12% of all cancer cases in the     island. The genetic epidemiology of CRC among Hispanic populations is not well studied, hence     studies focused on large, well defined ethnic groups such as Puerto Ricans, are clearly     warranted. The first step towards evaluating the molecular, environmental, and genetic     epidemiology of CRC in PR is to establish a population-based familial CRC registry. The     following specific aims have been proposed:      Specific Aim 1: To prospectively identify and recruit approximately 300 CRC probands from two     distinct geographical areas in PR (Metropolitan and Southern Region). From each proband the     investigators will obtain a pedigree extended to second-degree relatives and cousins.     Assuming 10% will be positive for a family history of CRC, the investigators will then     recruit all 30 probands with a family history of CRC and a sample of 15 family-history     negative probands and obtain: paraffin-embedded tumors blocks, blood samples, risk factor and     food frequency questionnaires.      Specific Aim 2: To prospectively identify and recruit selected relatives (parents,     grandparents, and same generation relatives - cousins and siblings) from the 45 probands     identified in Specific Aim 1. In addition, for siblings and cousins of probands (i.e.     relatives in the same generation as the proband), the investigators will obtain risk factor     and food frequency questionnaires, and for colorectal cancer cases, tumor blocks and     pathology reports of their cancers.      Specific Aim 3: To estimate from this pilot study the following parameters: (a) response rate     of probands and their selected relatives; (b) response rate of participants for each data     item; (c) family history of CRC and other cancers; (d) number of living first- and     second-degree relatives and cousins of probands; (e) number of these relatives who live in     the same household and region/municipality; (f) prevalence/distribution of selected risk     factors from the administered questionnaires.   "
235004|NCT00929617|"     The purpose of the study is to compare the effects of one exercise/counseling protocol with     usual care on long term exercise adherence and on changes in health related outcomes after     breast cancer diagnosis.   "
234734|NCT00927706|"     The purpose of this study is to determine the effectiveness of an assistive technology     updating and tune up intervention on users and their caregivers. This intervention includes 4     components:        -  an in-residence assessment of the mobility preferences of the older person and his/her          caregiver        -  a detailed review of forms of assistance, technological and human, that are currently          being used        -  recommendations by an occupational therapist for possible changes in the older person's          mobility assistive technology or assistance strategy        -  therapist negotiation of an mobility assistive technology updating and tune-up          intervention plan with the individual and his or her caregiver. The intervention is          provided to the immediate treatment following the administration of baseline measures          and the delayed intervention group six weeks later, after an additional baseline          measurement. The treatment is six weeks long and the follow-up is 26 weeks.      Hypothesis 1: For community-dwelling older people, an intervention that increases the     appropriateness of existing or new assistive technology(AT) for mobility or self-care will     alter established patterns of human assistance, such that caregiver burden is reduced or     eliminated.      Hypothesis 2: At the same time, AT users will report less difficulty in mobility or     self-care, as well as enhanced subjective well-being, and satisfaction with their modified     personal assistance strategy.      Hypothesis 3: Following the AT intervention, caregivers will report reduced physical and/or     psychological demands and increased satisfaction with their caregiving-related activities     compared with        -  the pre-intervention period        -  caregivers in a delayed intervention control group. Hypothesis 4: Decreased physical          and/or psychological demands on helpers will be associated with increases in device          users' satisfaction with their personal assistance strategies.   "
234735|NCT00927719|"     This is an enhanced safety surveillance study that will occur within the military Service     Member population.      Primary Objective:        -  To evaluate the rates of suspected, probable, and confirmed myocarditis and/or          pericarditis in temporal association with ACAM2000® vaccination.      Secondary Objectives:        -  To evaluate the rates of cardiovascular adverse events in temporal association with          ACAM2000® vaccination.        -  To evaluate the rates of neurological adverse events in temporal association with          ACAM2000® vaccination.   "
234736|NCT00927732|"     The specific aim of this study is to determine whether hydroquinidine administration can     prevent heart from appearance of ventricular arrhythmia detected by the automatic implantable     defibrillator (ICD).   "
234737|NCT00927745|"     The purpose of this study is to evaluate the long term use of AutoFlow mode during mechanical     ventilation in ICU patients   "
234738|NCT00927758|"     To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with     inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for     Asthma (GINA) guidelines.   "
234739|NCT00927771|"     The purpose of this study is to compare the safety and effectiveness of Azelaic Acid Gel to     Hydroquinone Cream in the treatment of melasma.   "
234740|NCT00927784|"     Left ventricular assist devices (LVADs) are one treatment option for people with congestive     heart failure. This study will evaluate the safety of injecting mesenchymal precursor cells     (MPCs) into the heart during LVAD implantation surgery and examine if injecting MPCs into the     heart is effective at improving heart function.   "
234758|NCT00928018|"     This trial is comparing whether using a drug called sirolimus for graft versus host disease     (GVHD) prevention can decrease the chance of the participant's lymphoma relapsing after     transplantation, compared to using a standard GVHD prevention regimen without sirolimus.     Since mTOR inhibitors have anti-lymphoma activity, their use after transplantation may lead     to a decreased risk of relapse and hence better transplantation outcome.   "
234759|NCT00928031|"     The objective of this study is to collect disease status and overall survival information for     all Subjects in MDX-010 studies.   "
234783|NCT00928343|"     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)     subcutaneous and single oral dose of GLPG0187 compared to placebo.      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous     and oral administration will be evaluated, and, if applicable, the maximum tolerated dose     determined.   "
234741|NCT00927797|"     The combination of Fludarabine and Cyclophosphamide have yielded overall response rates of     over 80% in previously untreated patients with indolent Non-Hodgkin-Lymphoma. However,     hematotoxicity rates were high with Grade 3 and 4 toxicities of over 50%. Several studies     have indicated that the treatment with Pentostatin and Cyclophosphamide causes lower     hematotoxicity rates than the combination of Fludarabine and Cyclophosphamide. To evaluate     the efficacy and safety of treatment with Pentostatin/Cyclophosphamide immuno-chemotherapy     for patients with newly diagnosed or relapsed Immunocytoma/Morbus Waldenström, B-cell chronic     lymphocytic leukemia (B-CLL) and other indolent CD20-positive B-NHL, an open, non-randomized,     multi-center prospective phase II-study to evaluate the efficacy and safety of treatment with     immuno-chemotherapy is conducted. Treatment consists of 6 courses of Pentostatin (4mg/m² on     day 1), Cyclophosphamide (600mg/m² on day 1) and Rituximab (375mg/m² on day 0) administered     every three weeks. Patients achieving complete or partial remission undergo maintenance     therapy consisting of 8 courses of Rituximab (375mg/m²) administered every three months over     a period of 2 years.   "
234742|NCT00927810|"     This 24-week open-label extension study is designed to provide additional long-term safety     data up to a total of 1-year for patients rolling over from the core study, and to collect     further efficacy and tolerability data for all the patients, irrespective whether they have     an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885)     in this extension study.   "
234743|NCT00927823|"     A phase 1 dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of     PF-04691502 in adult cancer patients with solid tumors.   "
234744|NCT00927836|"     The purpose of this study is to assess the efficacy of AX200 (filgrastim) in the treatment of     acute ischemic stroke and to assess the safety and tolerability of AX200.   "
234745|NCT00927849|"     Idiopathic hypertensive anal canal is a fact and already exists presented by anal pain     aggravated by defecation. It can be managed safely by closed lateral sphincterotomy but     chemical sphincterotomy had a minor role in its management.   "
234763|NCT00928083|"     OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent.      This was a Phase I, single-centre, multi-component, double-blind, randomised,     placebo-controlled study in healthy male and female subjects. The study was conducted in 3     parts:        -  Part A investigated the safety, tolerability and pharmacokinetics (PK) of single oral          escalating doses of OZ439. Up to 6 dose levels will be investigated to estimate dose          proportionality.        -  Part B, the effect of food on a single oral dose of OZ439 was investigated in a 2-way          crossover design.        -  Part C investigated the safety, tolerability and PK profile of multiple oral doses of          OZ439.      The starting oral dose was 50 mg and the maximum single dose to be administered did not     exceed 1600 mg per subject. The maximum duration of dosing proposed was 3 days.   "
234746|NCT00927862|"     The purpose of this study is to determine whether DNA analysis improves the efficiency of     dosing and safety in patients who are being started on warfarin therapy.Warfarin, a blood     thinner (anticoagulant) prescribed to 1-2 million patients in the United States, is a leading     cause of drug-related adverse events (e.g., severe bleeding), in large part due to dramatic     (20-fold) differences between individuals in dose requirements. At least half of this     variability now can be explained by 3 common genetic variants, age, body size, and sex;     however, warfarin therapy continues to begin with the same dose in every patient with the     correct individual dose determined by trial and error. This study proposes to determine     genetic variations the same day from DNA simply obtained by swabbing the inside of the cheek     and use this information to determine the proper dose regimen individually in each patient.     The aim is to show that the investigators can achieve more rapid, efficient, and safe dosing     in up to 500-1000 individuals who are initiating warfarin therapy for various clotting     disorders across a large healthcare system in order to demonstrate improved dosing     effectiveness, efficiency, and safety with genetic-based dosing, which could lead to a     nationwide application resulting in as much as a $1 billion dollar annual benefit in     healthcare outcomes.   "
234747|NCT00927875|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923     administered in combination with carboplatin and etoposide followed by BMS-833923 alone in     subjects with extensive-stage Small Cell Lung Cancer (SCLC).   "
234748|NCT00927888|"     The aim of the study is to quantify postoperative pain after functional endoscopic sinus     surgery (FESS) and investigate whether preemptive analgesia may positively impact     intraoperative anesthetic management, decrease patient postoperative pain and discomfort, and     improve patient functional outcomes.   "
234749|NCT00927901|"     This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate,     xinafoate and acetate) in patients with asthma.   "
234750|NCT00927914|"     The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on     peroneal motor nerve conduction velocity relative to placebo in subjects with mild to     moderate diabetic sensorimotor polyneuropathy.   "
234751|NCT00927927|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and     signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002     in patients with rheumatoid arthritis.   "
234752|NCT00927940|"     The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting     Coronary Stent for the treatment of de novo lesions in native coronary arteries.   "
234753|NCT00927953|"     This study will test a drug called MGAWN1 for the treatment of West Nile infections.   "
234754|NCT00927966|"     The purpose of this research study is to determine the safety of the combination of RAD001     and CP-751,871, as well as the highest dose of this combination that can be given to people     safely. RAD001 is a newly discovered drug that may stop cancer cells from growing abnormally.     This drug has been extensively studied in many cancers. In particular, it has shown to be     effective in slowing down the growth of kidney cancer. CP-751,871 is another newly discovered     drug that may stop tumor growth. It is currently being studied in a wide variety of cancers,     and information from those other research studies suggests that these two drugs in     combination may help to stop cancer growth.   "
234755|NCT00927979|"     In our prospective, randomized, placebo controlled and double-blinded study we will study the     efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecologic     laparoscopic surgery. This is a second steady with protocol of general anesthesia used of     Remifentanil.   "
234756|NCT00927992|"     This study will analyze survival and outcome of patients with severe haemophilia who undergo     liver transplantation in Spain   "
234757|NCT00928005|"     Type 2 diabetes and prediabetes, which are mainly caused by a lack of physical activity and     excess weight, put people at an increased risk of cardiovascular disease. This study will     compare the effects of a weight loss diet versus a weight loss diet plus an exercise program     on body composition and cardiovascular factors that are early predictors of future     cardiovascular disease in overweight and obese people with type 2 diabetes and prediabetes.   "
234760|NCT00928044|"     Besides the removal of lesions, the purpose of surgeries has been extended to the improvement     of quality of life after procedures. Minimally invasive surgeries enabled women to experience     less pain, less hospital days. It is important to maintain the ovarian function because     ovarian hormones have protective effects about bone and cardiovascular diseases. Until now     many operation techniques for preserving ovarian function were used in gynecological field,     however, how much these methods affect on ovarian function is seldom known. For the     evaluation of remained ovarian function, ultrasound examination is useful method. However, it     might take several months till one can determine ovarian function and could not exactly     evaluate ovarian reserve. Until now, there have been controversies regarding ovarian function     after gynecological surgeries. These inconsistent results might derive from the methods for     assessing ovarian function because serum gonadotropins and sex steroids levels vary according     to the menstrual cycle.      In this aspect, anti-Müllerian hormone (AMH) has recently been advocated as a good marker for     ovarian reserve. AMH is one of the TGF-beta superfamily and induces the regression of     Müllerian duct. Studies with AMH showed no significant variation throughout the menstrual     cycle and cycle-to-cycle consistency, therefore, it will provide more reliable data on the     changes of ovarian reserve after operations.   "
234761|NCT00928057|"     Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin     therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy     profile of currently marketed pen needles may appeal to many diabetic patients as the new     needle may be perceived as less intimidating and more comfortable. Currently marketed pen     needles range in length from 5 to 12.7 millimeters (mm).      The primary purpose of this study was to evaluate whether the investigational 4mm x 32     Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent     glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G     and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.   "
234762|NCT00928070|"     This study is designed to assess the efficacy and safety of a flexible dose regimen of     fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects     with overactive bladder (OAB).   "
234764|NCT00928096|"     In this study, radiation therapy plans will be made for 20 consecutive patients with     mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphoma. One plan is done using a     breathing adapted pre-chemo PET-CT scan fused with a post-chemo planning CT scan and another     plan is done using the standard procedure with pre-chemo PET-CT fused with post-chemo     planning CT scan. Dose levels to the lymphoma and to the organs of risk will be compared in     each patient. The best radiation therapy plan will be used to treat the patient.   "
234765|NCT00928109|"     UCAN is a research program funded by the National Institute of Mental Health and is part of     the UNC Eating Disorders Program. UCAN aims to help couples work together in the treatment of     anorexia nervosa. Couples participate in UCAN over a period of six months and return for     follow-up treatment three months after the end of the original six-month period. Patients     receive weekly individual therapy, monthly psychiatry consultations, monthly dietary     consultations in addition to being randomized to one of two types of weekly couples therapy.     Participation in UCAN can help participants gain new confidence in facing anorexia as a team     and can help us understand how best to involve partners in the treatment of eating disorders.   "
234766|NCT00928122|"     This study evaluates the intrastromal correction of ametropia with a femtosecond laser made     by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which     enables very precise cuts in the cornea. By these cuts lamellae of the cornea are separated     locally, and in the consequence the curvature of the cornea is changed, and the correction of     the diagnosed ametropia can be achieved. On the contrary to cuts which are generated with a     sharp knife, the cuts generated when using a laser can be generated just inside the cornea     without opening the surface of the cornea. This means the procedure is minimal-invasive.      The study hypothesis is: Different types of ametropia can be corrected safely and on     long-term by intrastromal cuts.   "
234767|NCT00928135|"     Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and     recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt     concentration has been shown to increase activity of salt sensitive antimicrobial peptides.      Xylitol is a 5-carbon sugar that can lower the ASL salt concentration, thus enhancing innate     immunity. In this study, the investigators propose to test the safety and tolerability of     aerosolized xylitol used daily for 2 weeks in subjects with cystic fibrosis. In a pilot,     2-week study, 60 subjects with cystic fibrosis with an FEV1(Forced expiratory volume in 1     second ) >30% predicted will be randomized to receive aerosolized 7% hypertonic saline (5 ml)     or 15% xylitol, (5 ml) twice a day for 14 days. The primary outcomes will be safety as     assessed by FEV1 change from baseline, adverse events and respiratory symptom score. Outcomes     for trend in efficacy include density of colonization of sputum, time to next exacerbation,     sputum cytokines and revised CF quality of life questionnaire.   "
234768|NCT00928148|"     This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover     study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg)     compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults     with ADHD. The controlled environment used in this study is an analog classroom setting     adapted for a 16-hour adult day.   "
234782|NCT00928330|"     This multicenter, Phase Ib study is an open label, dose escalation, three-arm study     evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941     administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of     trastuzumab.   "
234769|NCT00928161|"     The goal of this clinical research study is to learn if radiation-induced xerostomia [RIX]     (dry mouth) causes, or worsens the effects of, acid reflux (heartburn and heartburn-like     symptoms) in head and neck cancer (HNC) patients receiving radiation therapy.      Objectives:      Primary Objective:      Determine if radiation induced xerostomia (RIX) increases the frequency or duration of     acid-reflux when re-measured approximately 6-12 weeks after RT (measured by # episodes, their     duration, and Reflux Area Index (RAI). Reflux Area (RA) is the sum of the area under the     curve for all episodes of pH<4 recorded during the study in units of Ph*minutes. The Reflux     area index (RAI) is the RA corrected for the duration of the study (RA x 100/study duration).      Secondary Objectives:        1. To demonstrate that patients undergoing RT for OPC have reflux into the irradiated field          that is anticipated to exacerbate mucositis symptoms        2. Correlate RAI and # episodes of acid reflux with salivary flow before and after RT to          determine if radiation induced hyposalivation is associated with more reflux events and          symptoms.        3. For patients with no pre-RT pathologic acid reflux, determine if RIX leads to conversion          to acid-positive reflux measured approximately 6-12 weeks after RT.        4. Correlate office indirect laryngoscopy findings (posterior commissure thickening,          cobble-stoning, granulomas, and arytenoids erythema or edema) suggestive of acid reflux          in OPC patients with pH-probe findings as was done in larynx cancer (Lewin et al)        5. Compare findings from the patient reported outcome (PRO) instruments used   "
234770|NCT00928174|"     The purpose of this study is to determine whether positron emission tomography / computed     tomography (PET/CT) using fluorine-18 fluorocholine as an imaging agent can characterize     regional responses to anti-androgen therapies in a manner that in the future aid in the     customized planning of treatments for patients with androgen-insensitive prostate cancer.   "
234771|NCT00928187|"     Since the first line antiretroviral (ARV) treatment is now largely accessible in the     Sub-Saharian Africa countries, documentation of virological failure, drug resistance patterns     and second line treatment evaluation are still to be consolidated in settings where viral     load monitoring is not available and non-B HIV subtype is predominant.      This trial aims at evaluating the efficacy and tolerance of 3 different second line treatment     strategies: two recommended by WHO combine two non-nucleoside reverse transcriptase inhibitor     associated with a ritonavir boosted protease inhibitor     (emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir);     the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet     evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a     better tolerance and its single daily administration may facilitate treatment adherence.   "
234819|NCT00921193|"     The study aims to evaluate the safety and performance of the RTPS in patients with localized     prostate cancer.The RTPS is an investigational device and requires permanent implantation of     a small radioactive fiducial, called the Blip, in the prostate.   "
234772|NCT00928200|"     This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form     using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients     with relapsed ALL who have developed an allergy to the E. coli formulation. This study will     administer the drug intravenously instead of the usual intramuscular route. The dose of     Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first     or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.   "
234773|NCT00928213|"     Assessment of biochemical and sonographic marker to predict the risk for developing     preeclampsia Among biochemical markers are serum level of Placental Protein 13 (PP13) and     Placenta Growth factor (PIGF). For sonographic marker Doppler pulsatility Index of the blood     flow through the uterine maternal arteries is assessed.      PP13 is produced by the placenta and released to the maternal blood circulation. It has been     shown to be an effective serum marker for early onset preeclampsia (Nicolaides KH et al.,     2005). The purpose of this study is to combined the assessment of the biochemical markers     with Doppler in the first and the second trimester to provide a comprehensive evaluation of     various methods for sequential and combined analysis to assess the risk for developing     preeclampsia.   "
234774|NCT00928226|"     We hope to determine the maximum tolerated dose of 3 session (i.e., treatment) stereotactic     radiosurgery to treat brain metastases greater than 4.2 cm3 in size. By increasing radiation     dose, we will determine if there is a better outcome without greater toxicity (side effects)     for patients.   "
234775|NCT00928239|"     The purpose of this study is to compare postoperative complications and outcome two different     attachment sites of the dorsal mesh support in laparoscopic sacropexy.   "
234776|NCT00928252|"     The purpose of this study is to determine whether imaging with 18F-choline PET/CT can provide     information that may help guide subsequent investigational or clinical treatments for     patients with advanced (hormone-refractory) metastatic prostate cancer.   "
234777|NCT00928265|"     This is a prospective observational multicenter registry to evaluate safety and efficacy data     on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an     intent to treat basis.      The objectives of this study are:        1. Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of          the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the          modified Rankin scale (mRS).        2. to evaluate adverse events.        3. Angiographic assessment at 12-18 months compared to the initial post-treatment          assessment via the modified Raymond scale and same/better/worse scale.   "
234778|NCT00928278|"     The purpose of this study is to investigate the time course of PF-04764793 concentration in     the blood following dosing by oral inhalation from dry powder inhalers.   "
234779|NCT00928291|"     In this study the investigators aim to test if a procalcitonin (PCT) - guided strategy allows     to reduce the antibiotic use in patients with febrile neutropenia hospitalized in a Brazilian     tertiary university hospital, causing no harm.   "
234780|NCT00928304|"     To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting     cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals     without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the     age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.   "
234781|NCT00928317|"     The purpose of this clinical trial is to assess the safety, efficacy, tolerability,     immunogenicity and pharmacokinetics of 3 dose levels of ART621 in the treatment of rheumatoid     arthritis.   "
235013|NCT00929734|"     The purpose of this study is to investigate whether rosuvastatin improves measures of     endothelial function, decreases measures of inflammation, and improves pulmonary function in     patients with stable chronic obstructive pulmonary disease.   "
234784|NCT00928356|"     The primary objective of this study is to assess the safety and effectiveness of same     sitting, simultaneous hybrid robotic assisted coronary artery bypass grafting (CABG) and     percutaneous coronary intervention (PCI) in the treatment of obstructive multivessel coronary     artery disease. A secondary objective is the assessment and standardization of optimal     operator techniques and comparative study of patients undergoing CABG during study period.   "
234785|NCT00928369|"     Young patients with adnexal lesions may have variable presenting symptoms. In this study, we     reviewed the clinical characteristics of young Korean patients who took the operation in     university hospital with adnexal lesions over the past 14 years.   "
234786|NCT00928382|"     One of the complications of having cancer in the spinal vertebrae is that it can spread and     lead to compression of the spinal cord. Spinal cord compression is a serious event that needs     to be treated quickly in order to prevent permanent damage to the spinal cord and nerves.        -  Researchers currently do not have the ability to accurately predict whether cancer of          the vertebrae will cause spinal cord compression. It is possible that accurate          predictions could allow doctors to treat patients even before they develop symptoms of          spinal cord compression, thereby preventing some of the long-term consequences.      Objectives:        -  To compare patients with cancer of the spinal vertebrae with and without symptoms of          spinal cord compression by looking at markers in the blood and changes on novel magnetic          resonance imaging (MRI) techniques that might allow researchers to predict who will          experience spinal cord compression before they actually begin to have symptoms.      Eligibility:        -  One group of healthy volunteers 18 years of age and older.        -  One group of patients 18 years of age and older who have cancer that has spread to the          vertebrae without symptoms of spinal cord compression.        -  One group of patients 18 years of age and older who have cancer that has spread to the          vertebrae with symptoms of spinal cord compression.      Design:        -  Healthy volunteers:        -  Blood will be drawn from each volunteer for initial tests and for more specific          biomarker tests.        -  Comprehensive MRI of the spine, followed by a special type of MRI called diffusion          tensor imaging (DTI). It is believed that DTI may be even more sensitive in revealing          spinal cord abnormalities than regular MRI sequences.        -  Patients with cancer of the vertebrae:        -  Researchers will obtain information such as pathology reports, laboratory results,          diagnosis and treatment history, physical exam (PE) information, results of scans such          as x-rays, MRI, computerized tomography (CT), and positron emission tomography (PET),          and planned treatment details.        -  Additional blood samples will be taken for specific biomarker tests.        -  Questionnaire about pain, unusual sensations or numbness, bladder or bowel problems, and          mobility.        -  Comprehensive MRI of the spine, followed by a DTI.        -  Patients who appear to have symptoms of spinal cord compression will be offered standard          radiation treatment.   "
234787|NCT00928395|"     This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe     and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have     completed the 12 weekly treatments of the original protocol, the 13 week follow up     assessment, be randomized to the PTNS arm, and be considered a positive responder with     moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All     consenting responders will continue with active PTNS therapy at an initially prescribed     protocol for approximately 3 months followed by individualized symptom-based frequency of     visits as determined by the subject along with their treating clinician, for up to a total of     33 months post initial 12-week therapy for a total of 3 years.   "
234788|NCT00928408|"     This is a multicentre, descriptive observational study of adult patients with primary HPT     receiving cinacalcet in clinical practice in a number of countries in Europe. Patients will     be enrolled within 1 month of initiating cinacalcet treatment, and data will be collected     prospectively for up to 1 year from initiation. Data will continue to be collected from     patients discontinuing cinacalcet before the end of this period.   "
234789|NCT00928421|"     To determine the effect and safety of Varisolve® 0.125% [0.2%]   "
234790|NCT00928434|"     The purpose of this study was to see if giving Degarelix every month for 7 months then stop     treatment for 7 months (intermittent therapy) would show a reduction of negative effects of     androgen deprivation therapy by increasing the quality of life while keeping prostate     specific antigen (PSA) levels suppressed.   "
234791|NCT00928447|"     The purpose of this study is to compare the effect and safety of rHuPH20 or placebo for the     treatment of skin allergic reaction to nickel. The study drug and placebo will be     administered by intradermal injection.   "
234792|NCT00928460|"     A preoperative electrocardiogram (ECG) is nearly routinely performed by anesthesiologists in     elderly non-cardiac surgery patients as part of pre-anesthesia evaluation. However, the added     value of this routine ECG beyond patient history and physical examination is questionable.     The ECGtrial will investigate the efficacy of routine preoperative electrocardiography in     patients undergoing non-cardiac surgery.   "
234793|NCT00928473|"     The Danish Childhood Obesity Biobank collects blood from obese and normal weighted children     to produce a scientific platform for research in obesity.   "
234794|NCT00928486|"     To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese patients     with previously treated multiple myeloma.   "
234795|NCT00928499|"     Sacral Nerve Stimulation (SNS) delivers non-painful, mild electrical pulses to the sacral     nerves to modulate the reflexes that influence the bladder, sphincter, and pelvic floor to     improve or restore normal voiding function. Sacral nerve stimulation is indicated for     refractory voiding dysfunction including urinary urgency/frequency, urinary urge     incontinence, and nonobstructive urinary retention. Since its introduction, SNS has undergone     significant improvements in design and application so that implantation is now a minimally     invasive procedure under local and intravenous (IV) sedation. However, despite the progress     made in advancing this therapy to a minimally invasive procedure, there are neither data nor     guidelines on ideal program settings. The purpose of this study is to evaluate the     programming parameter of cyclic versus continuous stimulation on efficacy of the therapy. If     the therapy is equally efficacious at both settings, the cyclic setting has the advantage of     resulting in a longer battery life.   "
234796|NCT00928512|"     This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in     patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48     with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457     treatment in combination with MTX in RA.   "
234797|NCT00928525|"     The purpose of this study is to determine whether Imatinib Mesylate is active in diseases -     such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived     growth factor (PDGF) both in its isoform alpha and beta   "
234798|NCT00928538|"     The purpose of this study is to determine whether nurses can help at-risk women reduce the     incidence of unintended pregnancy by providing them access to hormonal contraceptives in     their homes.   "
234799|NCT00928551|"     This study will compare two different formulations of vabicaserin.   "
234814|NCT00910481|"     This study will test the hypothesis that elective use of the Intra-Aortic Balloon Pump (IABP)     in patients undergoing high-risk Percutaneous Coronary Intervention (PCI) will reduce the     rate of in-hospital major adverse cardiac and cerebrovascular events compared to patients who     are managed without planned insertion of IABP.   "
234800|NCT00928564|"     Pelvic floor tension myalgia (PFTM) is increasingly noted in patients with chronic pelvic     pain. Pelvic floor physical therapy is typically utilized and is at times combined with other     therapies such as botox injections, trigger point injections or pudendal blocks. The     investigators' study will randomize newly diagnosed patients with PFTM to weekly physical     therapy with weekly pudendal blocks or placebo saline injection. Participants randomized to     physical therapy with placebo injections that have a visual analog scale score of greater     than 4 at 6 weeks may cross-over to the pudendal block group. Final patient assessment will     be performed at 6 months to assess durability of response.      Primary hypothesis: The addition of pudendal blocks to standard pelvic floor physical therapy     will result in lower pain and pelvic floor muscle tension scores, lower baseline vaginal     pressure and increase pelvic floor strength.      Secondary hypothesis: The addition of pudendal blocks to standard pelvic floor physical     therapy will result in a lower pain score in a shorter time frame, resulting in faster     progress through physical therapy.   "
234801|NCT00928577|"     Primary Objectives:        -  To compare the rates of myopericarditis (subclinical, suspected, probable, or confirmed)          in deploying military subjects who received ACAM2000® vaccine to rates among subjects          positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do          not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD          healthcare providers) or due to conditions or characteristics of their contacts.        -  To identify cases of subclinical myopericarditis in deploying military subjects who          received ACAM2000 vaccine.      Secondary Objectives:        -  To compare the rates of severe and serious dermatologic adverse events observed in          deploying military subjects who received ACAM2000® vaccine to rates among subjects          positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do          not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD          healthcare providers) or due to conditions or characteristics of their contacts.        -  To compare the rates of severe and serious neurological adverse events observed in          deploying military subjects who received ACAM2000® vaccine to rates among subjects          positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do          not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD          healthcare providers) or due to conditions or characteristics of their contacts.        -  To compare the rates of adverse events observed in subjects approximately 10 days          following their ACAM2000® vaccination to rates among subjects positioned to deploy who          would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000          vaccine due to recency of prior vaccination (as determined by DoD healthcare providers)          or due to conditions or characteristics of their contacts.        -  To evaluate potential risk factors associated with the development of confirmed,          probable, and/or suspected ACAM2000-associated myopericarditis.   "
234802|NCT00928590|"     The purpose of this study is to describe the long-term safety of a fixed combination product     containing an alternative preservative, dosed once daily for 12 months, in patients with     open-angle glaucoma or ocular hypertension.   "
234820|NCT00921206|"     The objective is to assess the humoral and cellular immune response of the VAX102 vaccine     delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults     against the influenza A virus M2e antigen after each vaccination.   "
234821|NCT00921219|"     The purpose of this study was to compare the pharmacokinetic and bioavailability profile     (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin     solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken     after a standard meal. The study is designed in accordance with the EU Note for Guidance on     the Investigation of Bioavailability and Bioequivalence 2001.   "
234803|NCT00928603|"     Surgery and irradiation for organ confined prostate cancer provide excellent long-term cancer     control but they may be accompanied by a risk of side effects that decrease quality of life.     Due to the stage migration of prostate cancer, the potential for patients to undergo     unnecessary treatment and the risk of treatment related morbidity, has been     increased.Alternative strategies that offer the possibility of delaying, obviating or     minimizing the impact of treatment maintaining the same oncological long term results have     been investigated. Despite pros and cons active surveillance has not gained popularity in men     with low risk prostate cancer as only 7% of men with localized prostate cancer remain in     active surveillance.      Traditionally solid tumors have been treated with radical surgery but selective, organ     sparing therapies are now common for tumors of the breast, skin and kidney, resulting in     equivalent rates of cancer control, lower morbidity rates and less disfigurement. With this     in mind the potential role of focal ablative therapy for localized prostate cancer might be     considered.      The researchers will investigate the feasibility and the efficacy in term of quality of life     and oncologic results of focal therapy by a pilot not randomized prospective study in a     patients with localized prostate cancer who meet low risk criteria based on clinical, biopsy     and imaging data.   "
234804|NCT00928616|"     The purpose of this study is to evaluate the effects of a diet supplementation with plant     sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.   "
234805|NCT00928629|"     The primary objective of the study is to establish the prevalence of lower extremity     peripheral arterial disease (PAD), defined as an ankle-brachial index of less than or equal     to 0.9, in subjects with at least two of the specified cardiovascular disease (CVD) risk     factors, with no overt cardiovascular disease.   "
234806|NCT00928642|"     This study will evaluate the efficacy and tolerability of the combination of Gleevec and     Gemzar in patients with ovarian cancer, who have progressed after receiving at least one     prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and     Gemzar is an IV chemotherapy drug used. Participation in the treatment portion of the study     will continue as long as the patient's tumors shrink or remain stable and as long as the     patient is able to tolerate the study drug. The follow-up portion of the study will last for     5 years.   "
234807|NCT00928655|"     The purpose of the study is to investigate the effect of nasal continuous positive airway     pressure in combination with acetazolamide as a treatment for sleep related breathing     disturbances in patients with the obstructive sleep apnea syndrome living at low altitude     during a sojourn at moderate altitude.   "
234808|NCT00910403|"     The Presbyopia Algorithm subject to this study has been specifically developed to     prospectively generate a treatment file for the Technolas 217z100 laser that will provide     Presbyopia correction among eyes with primary hyperopia or hyperopic astigmatism (distance     correction). The treatment algorithm provides a bilateral, multifocal ablation with a center     near addition, thereby allowing good focus over a range of object distances.   "
234809|NCT00910416|"     The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic     parameters. Nowadays it can be evaluated by several monitoring methods, derived from     electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton,     USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical     Devices Inc., Cleveland, OH 44103, USA). The goal of this study is to compare both monitoring     modalities during anesthesia.   "
234810|NCT00910429|"     Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348)     will be asked to participate in this long term extension study with BAY63-2521. The aim of     the long term study is to collect additional information to evaluate the safety and     tolerability of BAY63-2521. Patients will be treated with open label medication on their     individual optimal dose between 0,5 mg - 2,5 mg tid.   "
234811|NCT00910442|"     The aim of this study is to investigate the responses of the serum amyloid A (SAA) pathway to     dietary supplements of glutamine (Gln) and cysteine (Cys) together with methionine     (Met)-overloading in HIV+ patients comparatively to healthy controls.   "
234812|NCT00910455|"     This is the first study of SRX246 in humans, and is being conducted to begin to establish a     safety profile of orally administered SRX246.   "
234813|NCT00910468|"     This is a retrospective, case-control study of 75 patients having undergone a     robotic-assisted laparoscopic myomectomy were compared to patients having undergone     myomectomy via laparotomy. Both groups had 3 or fewer fibroids confirmed by pre-operative MRI     or on final pathology report. Charts were reviewed for surgical and post-operative variables   "
234816|NCT00921154|"     The purpose of this study was to compare the pharmacokinetic and bioavailability profile     (rate and amount of absorption into the bloodstream) of a test formulation of ivermectin     solution 1 mg/ml with a marketed reference formulation of ivermectin 3 mg tablets when taken     after an overnight fast .The study is designed in accordance with the EU Note for Guidance on     the Investigation of Bioavailability and Bioequivalence 2001.   "
234817|NCT00921167|"     To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with     recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme   "
234818|NCT00921180|"     Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with     HBeAg positive CHB, with the overall HBeAg seroconversion far from satisfactory. Therefore,     efforts on the various combinations with the currently available drugs are needed to improve     the overall response rates. The simultaneous combination therapy with oral nucleoside and     peginterferon alfa-2a from large-scaled randomized trials did not show a superior response     rate over peginterferon alfa-2a monotherapy. Recently, sequential monotherapy with lamivudine     for the first 4 weeks, followed by weekly peginterferon alfa-2a has shown favorable HBeAg     seroconversion rate over peginterferon alfa-2a monotherapy, based on the assumption that     early viral suppression by lamivudine can restore the immune function to facilitate the later     immunomodulatory response by peginterferon alfa-2a. With the recent introduction of     entecavir, the more potent oral nucleoside with few drug resistance, sequential monotherapy     with entecavir can potently suppress HBV DNA with 4 weeks of treatment, which may facilitate     the response of peginterferon alfa-2a to achieve HBeAg seroconversion. Therefore, we aimed to     conduct a placebo controlled randomized control trial to evaluate of adding entecavir early     in the course of therapy can improve the treatment response.   "
234824|NCT00921258|"     This study concern a prospective cohort pf patients with latent prostate cancer. We study the     specific survival at 10 years of patients who accept an active control.Patients inclusion are     realized in 2 stages:        -  patient with inclusion criteria (PSA < 10 ng/ml, clinical stage T1c or T2a, Gleason < or          = 6) are registered if they accept a second prostate biopsy in a 3 months delay        -  after analyse of second biopsy in central laboratory and confirmation of latent prostate          biopsy, patients are included if they accept active control Included patients will have          1 biopsy by years the first two years and then 1 biopsy each 2 years during 8 years.      If progression of cancer happens during the 10 years control, active control will be stopped     and patient will be treated by surgery and chemotherapy.   "
234825|NCT00921271|"     This study aims to determine how infrared spectroscopy compares to continuous compartment     pressure monitoring in the detection of compartment syndrome.      Individuals meeting the study eligibility criteria will be identified at time of admission by     the receiving Trauma and Orthopaedics Registrar who will be trained in the study design and     protocols.      Eligible individuals will be approached about participating in the study either at time of     admission or shortly afterwards, either by the chief investigator or another doctor trained     in the research protocol. Where the individual is unconscious or otherwise incapacitated,     which is likely in many major trauma victims, inclusion in the study will be discussed with     the patient's legal representative and/or family.      The consent process for the study will consist of having the study protocol explained by     either the chief investigator, or another doctor trained in the study design. Patients will     be allowed to read a participant information sheet, and permitted as much time as they     require to decide if they wish to participate in the study. Verbal and written consent will     be taken using a study specific consent form.      In the case of incapacitated patients, the study design will be explained to their relatives'     legal representatives as appropriate and advice sought from them as to whether they know of     any reason why the patient might object to participate in the study. Upon regain capacity     consent will be sought from the patient for storage and analysis of their study data.      Once consented, the patient will undergo monitoring with both continuous compartment     pressures, and NIRS measurements.      Recordings for both techniques will be taken each hour, as part of the patients normal     observations, from the point of consent until 24 hours after their first operation. Where     patients do not have an operation the total duration of monitoring will be 24 hours. The     measurements will be taken by nursing staff who have received training in both techniques.     The procedure for each technique is described below:        1. Continuous compartment pressures will be recorded in the broken leg, in case of tibial          fractures, in all other patients fitting the inclusion criteria measurements will be          taken from both legs (as both legs are at risk of compartment syndrome).           Compartment pressures will be recorded using a slit catheter technique. Insertion of the          slit catheter will be performed by either the chief investigator or Orthopaedic          Registrar who will have been trained in the technique. The slit catheter is inserted          using a sterile technique - the skin over the front outer part of the leg is cleaned and          a catheter inserted into the anterior muscle compartment at this point. The catheter          should be sited at the approximate midpoint of the leg, although this can be adjusted up          or down if this would lead to insertion into a fracture site. The catheter is secured          with a sterile dressing and connected to a monitor from which recordings can be taken,          the catheter can be left in place for the duration of the study with no need to re-site          it unless it stops recording accurately. At the same time as compartment pressure          measurements are taken the patient's blood pressure will be monitored and the 'Perfusion          Pressure' for the leg calculated, where:           Perfusion pressure = diastolic blood pressure - leg compartment pressure        2. NIRS measurements will be taken with an the INVOS system, produced by Somentics. These          measurements will be taken from both legs, the affected leg and other other leg used as          a control for comparison. Where both legs are at risk measurements will be taken from          both legs and the midpoint of the forearm used as a control.      The INVOS probe is a small adhesive patch that is stuck to the skin. The probe is sterile and     will be attached using the same sterile technique as the compartment pressure catheter. Where     the overlying skin is hairy the hair overlying the area for the probe should be clipped     before attaching the probe, to ensure adequate adhesion and accurate readings. The probe is     to be sited just below the compartment pressure catheter, although if there is an underlying     haematoma (blood clot), then the probe should be positioned so at to avoid this but still     remaining over the front outer part of the leg. This technique conforms with the     manufacturers recommended use of the equipment and is similar protocol to previous studies.      At the end of the monitoring period both measuring devices are removed. If the patient has     developed compartment syndrome during this period and required an operation, the NIRS probe     and compartment pressure catheter will be replaced for a further 12 hours of monitoring to     monitor the changes post-operatively and ensure compartment pressures stay low.   "
234826|NCT00921284|"     The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of     propofol and remifentanil.   "
234827|NCT00921297|"     Two very common aging-related diseases in older adults are Alzheimer's disease (AD) and     cataracts. In elderly adults, these two diseases frequently occur in the same person.     Although a cure for AD is currently unavailable, cataracts can be effectively treated with     surgery in most people. The removal of cataracts has documented benefits for visual     performance and for reducing accidents and falls. However, it has been the experience of the     ophthalmologists, and others in the field, that patients, caregivers, and primary care     doctors are reluctant to proceed with cataract surgery once an individual is given the     diagnosis of AD. It is thought that cataract surgery will not improve the AD patient's     quality of life, vision, and cognition. The investigators have designed this study to     determine whether or not this is true.   "
234828|NCT00921310|"     To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the     combination of temsirolimus and pemetrexed, as well as the response rate. The starting dose     (Dose Level 1) and schedule of pemetrexed will be 500 mg/m^2 given every 3 weeks and the     starting dose (Dose Level 1) for temsirolimus will be 15 mg given weekly for 3 weeks, to     complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment     to each cohort is based on toxicity experienced at that dose level.   "
234829|NCT00921323|"     The purpose of this study is:        -  To validate the use of pedometers in assessing the level of physical activity in middle          school children.        -  To evaluate whether setting a step goal through the use of pedometers could increase          physical activity and prevent weight gain in middle school children.   "
234830|NCT00921336|"     This study will determine the maximum dose of KW-2450 that can be administered safely to     subjects with advanced previously treated solid tumor and evaluate its effectiveness.   "
234831|NCT00921349|"     The value of banding ligation plus beta blocker in the prophylaxis of first episodes of     variceal bleeding has not yet been evaluated. This study was conducted to compare the     efficacy and safety of banding ligation plus nadolol versus nadolol in the prophylaxis of     first bleeding in cirrhotic patients with high-risk esophageal varices.   "
234832|NCT00921362|"     Patients eligible for entry into the study have a diagnosis of schizophrenia defined by     Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of     a chronic or sub-chronic nature.The primary purpose of the study is to observe symptoms     changes over 6 months in schizophrenia in patients treated with Seroquel; additionally     disease severity and treatment compliance are followed   "
234833|NCT00921375|"     This study is a prospective, open-label, multicentre study. Hundred eligible patients with     stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a     peripheral white blood cell (WBC) count of > 25,000/µL or any leukemia or lymphoma with     plasma uric acid level of at least 8 mg/dL will be treated with rasburicase 0.20 mg/kg body     weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in     plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and     incidence of adverse events will be assessed during 11 days study period.   "
234834|NCT00921388|"     This research study is being done to find out if adding a moderate exercise program or a     relaxation program to a smoking cessation treatment program will improve smoking cessation     and health in postmenopausal women. We hope to learn which group is more successful at     quitting, has less symptoms of withdrawal from smoking and has improved health.   "
234835|NCT00921401|"     It is important for people with asthma to become involved in their asthma care and     management. This study will evaluate an interactive Web site that provides tailored feedback     and information to asthma patients and encourages them to ask their doctor specific questions     about their asthma care.   "
234836|NCT00921414|"     Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance     therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment     for mantle cell lymphoma and exhibiting a response after autologous transplantation.   "
234837|NCT00921427|"     The purpose of our study is to explore the efficacy of combination of brain stimulation with     visual rehabilitation in patients with visual field loss resulting from brain lesions. It is     shown that the effect of sensorimotor training of hand can be enhanced in patients with     stroke using brain stimulation. We decided to explore this combination for visual field loss     because visual dysfunction following brain lesions is considered intractable. We hypothesize     that combination of noninvasive brain stimulation, in the form of transcranial direct current     stimulation (tDCS), with visual rehabilitation would have greater efficacy than visual     rehabilitation alone.   "
234838|NCT00921440|"     The investigators' rationale was to evaluate whether a 64-slice CT scanner allows accurate     measurement of computed tomographic changes in coronary artery flow profiles and whether CT     flow measurements are suitable for classifying the significance and hemodynamic relevance of     a stenosis and thereby supplement as a functional parameter for morphological stenosis     analysis.   "
234839|NCT00921453|"     Medical expert systems in combination with portal searching meta-search engines are exploited     to provide reliable patient-tailored information. A prototype of a web-based information     system has been developed and is to be evaluated. Its aim is to answer the decisive question     whether expert system guided internet meta-search provides a better information supply for     patients seeking health information online then this is possible by using ordinary search     engines or health portals. The research does neither investigate the influence of ethical nor     legal aspects of internet health information supply.   "
234840|NCT00921466|"     The proposed study is designed to evaluate the clinical contents of the e-SSRS-IVR with     respect to 1.the intent of the instrument (assess face and content validity), 2. system     validation with respect to programming integrity, 3. implementation feasibility in clinical     ill and healthy patient populations, and 4. criterion/predictive validity to discriminate     patient population with known clinical status differences.   "
234841|NCT00921479|"     The purpose of this study is to determine how quality of life changes after surgical removal     of wisdom teeth   "
234842|NCT00921492|"     Hypothesis The overall hypothesis is that non-obese (BMI <30) women with PCOS have high     luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated     low-frequency EA restore these alterations and induce ovulation.   "
234843|NCT00921505|"     The purpose of this study is to determine whether paracetamol, ibuprofen or their combination     can modify generation of radical oxygen species (ROS) from stimulated neutrophils.   "
234844|NCT00921518|"     Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in     serum creatinine concentration by at least 25% from baseline. It occurs in 30% of patients     following cardiac surgery, and at least 50% of patients with underlying renal insufficiency.     Patients who have a reduced creatinine clearance pre-operatively are at the greatest risk of     developing post-operative AKI. The purpose of the current study is to determine if     intravenous hydration with either isotonic saline or sodium bicarbonate 150 mEq/L is     effective at preventing post-operative AKI in patients with baseline kidney insufficiency and     who are undergoing cardiac surgery using cardiopulmonary bypass. The study hypothesis is that     an infusion of sodium bicarbonate 150 mEq/L will be more effective than isotonic saline in     reducing the incidence of post-operative AKI in cardiac surgery patients with a preoperative     glomerular filtration rate (GFR) less than 60 ml/min/1.73m2.   "
234845|NCT00921531|"     Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas.     Randomized clinical trials indicated that TACE improves overall survival in patients with     good liver function (Child-pugh A or B). However, the shortcoming of TACE is obvious: hypoxia     induced neoangiogenesis after blockage of blood supply of the tumor; repeat TACE deteriorates     liver cirrhosis due to toxicity of chemotherapeutic agent to the parenchyma liver.     Thalidomide has been reported to have antiangiogenic and antimetastatic effects. The     objectives of adjuvant therapy with thalidomide for chemoembolization is to evaluate overall     survival and time to progression.   "
234877|NCT00921947|"     1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the          VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level          delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.        2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102          vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered          i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked          immunosorbent assay (ELISA) in a healthy adult population.   "
234878|NCT00921960|"     The STOP-HF study is a prospective, randomized, controlled trial recruiting asymptomatic     individuals with risk factors for left ventricular dysfunction from 50 primary care clinics     in Dublin and south east Ireland. It is designed to determine whether using natriuretic     peptide measurement as a screening tool following a general cardiovascular risk factor screen     will reduce the prevalence and severity of ventricular dysfunction in conjunction with     specialist follow-up at St. Vincent's University Hospital.   "
234846|NCT00921544|"     Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and     therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care     Unit. Therefore strategies for stress reduction and pain management are essential to promote     growth and development and minimize long-term sequelae. Procedural analgesia should include     concepts of developmental care, non nutritive suck (NNS), pharmacological and     non-pharmacological agents. Sucrose is thought to stimulate the body's activation of lingual     sweet taste receptors and release of endogenous opioids, when combined with NNS, non-opioid     mechanisms are also activated. The administration of sucrose or the combination of sucrose     and non-nutritive sucking is one of the most frequently studied non-pharmacological     interventions for relief of pain in neonates and oral sucrose has been shown to be an     effective and safe therapy for common neonatal procedures such as heal lance, blood-letting     and venepuncture. There is conflicting evidence on the benefit of sucrose in ROP screening.     Therefore the purpose of this study is to determine the efficacy of sucrose combined with NNS     as a potential regime for reduction of pain associated with retinopathy of prematurity     screening.   "
234847|NCT00921557|"     HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be     expected for HIV-uninfected people of similar age, weight and race. As the majority of     perinatally HIV-infected U.S. children are entering or in adolescence, the potential for     HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular     concern. The primary purpose of this study was to compare changes from pre-treatment levels     of BMD of the lumbar spine after 24 and 48 weeks of alendronate treatment with placebo in     HIV-infected children and adolescents.   "
234855|NCT00921661|"     The primary objective is to determine the dose of aflibercept to be further studied in     combination with irinotecan/5-fluorouracil/isovorin (FOLFIRI) in Japanese patients with     metastatic colorectal cancer.      Secondary objectives of this study are to assess the safety profile of aflibercept, to     determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor     effects.   "
234856|NCT00921674|"     The purpose of this study was to compare the pharmacokinetic and bioavailability profile     (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin     solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken     after a standard meal. The study is designed in accordance with the EU Note for Guidance on     the Investigation of Bioavailability and Bioequivalence 2001.   "
234931|NCT00922662|"     The purpose of the study is to establish an overarching database of information containing     historical, demographical, clinical, and intermediate and long-term outcome data from all     William Beaumont Hospital (WBH) patients undergoing Cardiac Computed Tomographic Angiography     (CCTA) testing for clinical or scientific reasons.   "
234848|NCT00921570|"     Diabetic nephropathy (DN) is the most important complication of diabetes mellitus (DM) and     the most common cause of end-stage renal disease (ESRD). Diabetic nephropathy is a clinical     syndrome characterized by persistent albuminuria (> 300 mg/d or > 200 mcg/min) that is     confirmed on at least 2 occasions 3 to 6 months apart, a relentless decline in the glomerular     filtration rate (GFR), and elevated arterial blood pressure. In addition to the renal     hemodynamic alterations, patients with overt diabetic nephropathy (dipstick-positive     proteinuria and decreasing GFR) generally develop systemic hypertension. Hypertension is an     adverse factor in all progressive renal diseases and seems especially so in diabetic     nephropathy. The deleterious effects of hypertension are likely directed at the vasculature     and microvasculature. Use of angiotensin converting enzyme (ACE) inhibitors and/or     angiotensin receptor blockers (ARBs), strict glycemic control and use of antilipidemic drugs     may improve progression of DN.      TNF-like weak inducer of apoptosis (TWEAK, TNFSF12) is a member of the TNF superfamily of     structurally related cytokines. The human TWEAK gene encodes a 249-amino acid type II     transmembrane glycoprotein (30 kD). TWEAK may be expressed as a full-length, membrane-bound     protein and as a 156-amino acid, 18-kD soluble protein, (sTWEAK) that results from     proteolysis of TWEAK. TWEAK gene is expressed in many tissues, including brain, kidney,     heart, arterial wall, monocytes and macrophages. Reduced soluble TNF-like weak inducer of     apoptosis (sTWEAK) plasma levels have been reported both in patients with subclinical     atherosclerosis and chronic kidney disease (CKD).      Long pentraxin 3 (PTX3) is a multimeric inflammatory mediator. Increased serum PTX3 levels     have been reported among end-stage renal disease patients. Moreover, PTX3 has been suggested     to represent a novel mortality risk factor, and elevated PTX3 levels have been shown to     accompany increased albuminuria among patients with chronic kidney disease (CKD).      There is no data about the effects of Renin angiotensin system blockage (RAS), calcium     channel blocker and combined drugs on TWEAK and PTX3 levels in diabetic proteinuric patients     with hypertension. The aim of this study was to find out whether the beneficial effects of     RAS blockage, calcium channel blocker and combined drugs in diabetic hypertensive proteinuric     patients has any relation with the alteration of TWEAK and PTX3 levels. The investigators     searched for the effects of angiotensin II (AII) receptor blocker (Valsartan 160 mg), calcium     channel blocker (Amlodipine 10 mg) and AII receptor blocker plus calcium channel blocker     (Valsartan 160 mg + Amlodipine 10 mg) on the clinical and laboratory parameters of diabetic     hypertensive proteinuric patients.   "
234849|NCT00921583|"     Since 1986, newly developed titanium implants with a TPS surface have been utilized for the     treatment of partially edentulous patients with implant supported fixed dental prostheses     (FTP). In the beginning, these implant types have been sold by Straumann under the brand name     Bonefit implants, later ITI Dental Implant System From the beginning, the first 75     patients have been documented in a prospective case series study, and clinical and     radiographic results have been reported at 1-year, 3-years, 5-years and 8-years.      The aim of the present study is to examine the long-term outcomes of this original group of     patients with at 20 years of clinical function, and to assess the frequency of biological and     technical complications during this follow-up period.   "
234850|NCT00921596|"     Conventional cardiac operations are performed with median sternotomy, which is related to     great wound, morbidities, longer duration in hospital and most significantly, cosmetic     problems. The investigators invested a new minimally invasive cardiac operation method     totally under video-endoscope and peripheral cardiopulmonary bypass. The investigators'     hypothesis is that this new minimally method could provide better cosmetic effects to the     patients, and also relate to shorter postoperative hospital stay and better recovery.   "
234851|NCT00921609|"     Acromegaly is a rare disorder characterized by excessive production of growth hormone most     often by a pituitary adenoma. A pituitary adenoma is a tumor, almost always benign or     non-cancerous, that grows on the pituitary, a small gland located at the base of the brain.     Treatment of acromegaly usually involves surgery, medication, or radiation, but can involve a     combination of these three treatments.      Subjects for this study will be recruited if they are:        1. Adults, male or female, between the ages of 18-90.        2. Have been diagnosed with acromegaly, based on elevated levels of growth hormone, IGF-I          (a hormone made in response to growth hormone), and a pituitary adenoma visualized on an          MRI.        3. Patients would have already agreed to have their acromegaly treated with surgery prior          to study entry.      Subjects will have measurements of growth hormone using an oral glucose tolerance test     (OGTT), IGF-I, free IGF-I and levels of IGF binding proteins at four time points after their     pituitary surgery: Day 1, Day 42 (6 weeks), Day 84 (12 weeks), and day 365 (1 year). Subjects     will also have an MRI of the pituitary done at 12 weeks and 1 year. OGTT and IGF-I are     routinely measured to assess whether or not a person is cured of their acromegaly. An MRI of     the pituitary is routinely done at 12 weeks and 1 year after surgery to assess the results of     surgery. Free IGF-I and IGF binding proteins are not routinely measured after surgery, but     are being done to see if they relate more strongly to disease activity than IGF-I and growth     hormone.      OGTT and the IGF-I binding proteins are not routinely measured on the day after surgery, but     are being done to examine the predictive ability of these tests at a very early time after     surgery. Data obtained from these tests will be compared to the data gathered at the 1 year     time point.      IGF-I and growth hormone will be measured by a commercial clinical lab, Quest Diagnostics,     for clinical decision-making at the time of service. IGF-I and growth hormone will also be     measured using other methods to attempt to investigate the variability of these hormones when     different assays are used.   "
234879|NCT00921973|"     The study will assess the safety, reactogenicity, and tolerability of VAX102 when given with     Trivalent Inactivated Influenza Vaccine (TIV) delivered in the same arm as two separate IM     injections in healthy adults 18 to 49 years. The investigators will measure the     immunogenicity of the VAX102 when given with TIV and the antibody response to TIV when given     with VAX102 compared to TIV alone.   "
234880|NCT00921986|"     Biorepository of blood and or tissue samples from patients presenting with cardiac arrhythmia     syndromes.   "
234895|NCT00922181|"     Microwave ablation (MWA) is the most recent development in the field of local ablative     therapies. The aim of this study was to evaluate the variability and reproducibility of     single-probe MWA versus radiofrequency ablation (RFA) of metastatic liver tumours smaller     than 3 cm in patients without underlying liver disease.   "
234852|NCT00921622|"     There is suggestive evidence that vitamin C and vitamin D deficiency may increase blood     pressure across the range of blood pressures from normal to elevated. Information about this     relationship is inadequate in part because of the rarity of individuals with subclinical     vitamin C and D deficiency. The investigators have observed subnormal to deficient plasma     vitamin C and 25-hydroxyvitamin D levels in a large proportion of patients under active     treatment in the investigators' hospital. The clinical implications of widespread     hypovitaminosis C and D are unknown. In this randomized prospective comparison trial the     investigators will measure vitamin levels and blood pressure in clinically stable acutely     hospitalized patients with a wide range of diagnoses, and expected to remain in the hospital     for at least 7 more days. The investigators will examine for an inverse relationship between     baseline vitamin level and blood pressure across the range of blood pressures. Consenting     patients will be randomized to receive vitamin C (500 mg twice daily) or vitamin D (1000 IU     twice daily) for as long as 10 days. Blood pressure will be re-measured every 2 days and     vitamin levels re-measured on the last study day. Treatment courses of at least 5 days will     be considered sufficient for analysis. The hypothesis is that either treatment will reduce     blood pressure in patients whose baseline systolic blood pressure is 110 or more; the     investigators will also examine whether the reduction in blood pressure with treatment is     proportional to the increase in the circulating vitamin level with treatment.   "
234853|NCT00921635|"     The purpose of this study is to assess the feasibility, safety and short term effects on     health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100     to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for     cancer of the cervix.   "
234857|NCT00921687|"     Chronic kidney disease (CKD) is defined as kidney damage for greater than 3 months or a     glomerular filtration rate less than 60 mL/min per 1.73m2 for greater than 3 months. Patients     with CKD are at high risk for development of cardiovascular disease and metabolic     complications. Guidelines for the care of patients with CKD have been developed by the     National Kidney Foundation. Despite the wide availability of these guidelines, adherence is     low. The goal of the current study is to evaluate whether a multifactorial intervention,     including a CKD registry, will improve CKD guideline adherence. The hypothesis is that     providers exposed to a multifactorial clinical intervention including education, academic     detailing, and a CKD registry will be more likely to adhere to CKD guidelines than those only     exposed to education.   "
234858|NCT00921700|"     The purpose of this study is to determine whether the combination of paracetamol     (acetaminophen) and other NSAIDs with or without weak opioids can give synergistic analgesic     effect.   "
234859|NCT00921713|"     The purpose of this proposal is to develop and test the efficacy in a randomized, controlled     clinical trial of an Oncology Nurse Care Management (ONCM) program to support cancer patients     early in their course. The ONCM program will be compared with an Enhanced Usual Care (EUC)     program that will provide education materials and treatment resources for patients. Efficacy     will be measured by differences over time in participant-reported Quality of Life, Symptoms     and Emotional Distress, and Quality of Care between patients receiving ONCM versus EUC.   "
234860|NCT00921726|"     Due in part to widespread availability of oseltamivir and clinical experience using     oseltamivir to treat H5N1 influenza virus infections, many strains of influenza have become     resistant to it. Other reliable methods of treating H5N1 must be identified in case of a     pandemic. One such option is intravenous zanamivir used in combination with oseltamivir. The     primary purpose of this study is to evaluate the interaction between oral oseltamivir and     intravenous zanamivir administered as either a continuous or intermittent infusion in healthy     adults.   "
234861|NCT00921739|"     Hypothesis 1- Using IMRT, the radiation therapy (RT) dose can be safely escalated from 58 Gy     to 74 Gy given as 6 fractions/week with concurrent chemotherapy.      Hypothesis 2- Esophageal motion can be used to customize planning organ at risk volumes.      Hypothesis 3- Biological predictors of acute esophagitis can be used to identify patients at     high risk of developing esophageal toxicity from radiation therapy and chemotherapy.   "
234862|NCT00921752|"     To demonstrate a higher percent rate of achieved target lipid goals among patients at high     cardiovascular risk using more potent lipid-lowering treatment options including high-potency     statins and combination therapies.   "
234863|NCT00921765|"     The purpose of this study is to determine whether the analgetic and other effects effect of     ketamine are partly mediated through opioid receptors   "
234891|NCT00922129|"     The purpose of this study is to evaluate the role and effectiveness of conversion to     sirolimus versus CNI reduction in renal transplant patients with prostate cancer.   "
234892|NCT00922142|"     Hypothesis:      There is no significant difference in Cesarean patients' perceptions of overall pain     management satisfaction between methods used for postoperative pain management.   "
234893|NCT00922155|"     The purpose of this study is to examine the usefulness of a balloon covered sheath as a guide     sheath in endobronchial ultrasound guided transbronchial biopsy and bronchial brushing     cytology for diagnosis of peripheral lung lesions   "
234894|NCT00922168|"     The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered     breathing in cardiac surgery patients.   "
235036|NCT00930033|"     The study compare the standard treatment with nephrectomy + sunitinib to treatment with     sunitinib alone without nephrectomy. This study will be the first trial on this competitive     context   "
234864|NCT00921778|"     The occurrence of persistent vaginal bleeding following laparoscopic supracervical     hysterectomy (LSH) is reported in the wide range of 0 % - 25 %. Experienced gynaecologists     have claimed that removal of any remaining endometrium in a reverse cone pattern at the time     of the hysterectomy reduces the occurrence of persistent vaginal bleeding to a minimum. The     effect of this particular technique has not been reported.      Ullevaal University Hospital have developed an unipolar electrode for this study (Lapcone     electrode, mod. UUS, L: 25cm, 6x10, Art. No. REM-270, Ross Electro Medical Ltd, Unit K1&K2,     Quarry Fields Estate, Mere, Wiltshire BA12 6LA, London, UK). The electrode is CE approved.      Outcome: 1.Occurrence of vaginal bleeding 12 months after the procedure. 2. Patient     satisfaction 12 months after the procedure (10-point analogue scale).      Design: Prospective randomised trial. Methods; The study participants are randomised to     laparoscopic supracervical hysterectomy performed by perioperative electrocoagulation from     the upper cervical canal (n=70) or performed by excision of the endocervix in a reverse cone     pattern followed by electrocoagulation of the upper cervical canal (n =70).   "
234865|NCT00921791|"     High blood pressure is the main risk factor for cardiovascular disease worldwide,but its     control rate is unsatisfactory. Home Blood Pressure Monitoring (HBPM) with automatic     oscillometric devices and pharmaceutical care have been proposed as interventions to increase     therapeutic compliance and to guide treatment decisions.      The purpose of this study is to evaluate the effect of HBPM and of pharmaceutical care in     blood pressure control measured through 24h ambulatory blood pressure monitoring (ABPM).   "
234866|NCT00921804|"     The purpose of this study is to determine whether treatment with daily oral dose of AZD8529     40 mg administered over 28 days is safe, well tolerated and improves main symptoms of     schizophrenia in adult schizophrenia patients.   "
234867|NCT00921817|"     This study will test a new method for measuring body fat and muscle in infants and children:     QMR.   "
234868|NCT00921830|"     The purpose of this study is to compare the pharmacokinetic and bioavailability     characteristics of two test formulations of ibuprofen for rectal administration with the     profile of a marketed reference formulation of ibuprofen 200 mg (for oral administration).   "
234869|NCT00921843|"     This study will determine the pharmacokinetics of intravenous (IV) methadone in children     undergoing surgery.   "
234954|NCT00922961|"     25 patients, treated by brachytherapy in a phase II study Mammosite (from 2003 to 2005),     will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due     to brachytherapy.      During this consultation, a blood sample will be taken for analysis ( rate of CD8     T-Lymphocyte Apoptosis)   "
234870|NCT00921856|"     In patients with chest pain and/or shortness of breath coronary artery disease (CAD) is     suspected depending on the pattern of symptoms and the electrocardiogram (ECG). Coronary     angiography is the method of choice to verify this suspicion. If the patient coronary     arteries on coronary angiography are totally normal, one can only speculate if the patients'     discomfort is from the heart or not. A possibility to get further information about the     healthiness of the coronary arteries is the acetylcholine test (ACH-test). When injecting     this natural, body produced-substance into the coronary arteries one can test if the vessels     coronary spasm which can be the reason for the patient's symptoms. The investigators     therefore use this test in this study to look for coronary spasm in patients with suspected     CAD but normal coronary arteries. In case of a positive test, the patient profits from having     found a cause for his/her symptoms making treatment with special tablets possible.     Furthermore, the investigators want to analyze blood samples of every patient to look for     signs of inflammation that seem to be linked with coronary spasms. On the basis of these     results the ACH-test could probably be avoided in the future.   "
234871|NCT00921869|"     The purpose of this study is to determine the maximum tolerated dose (MTD), safety,     pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when     administered orally twice daily to patients with advanced solid tumors.   "
234872|NCT00921882|"     Within 6 months of delivery, women who had gestational diabetes mellitus should be screened     for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in     a 75-g oral glucose tolerance test. However, not all women are screened. The objective of     this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum     versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity,     false and true predictive values of the screening test at 48 hours post-partum compared to     the gold-standard.   "
234873|NCT00921895|"     To engage in a multi-center, prospective, masked clinical trial to investigate a     non-invasive, rapid diagnostic test, the RPS Adeno Detector IV's ability to detect the     presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to     cell culture with confirmatory immunofluorescence (CC-IFA). The polymerase chain reaction     (PCR) will be used as a referee for discrepant cases.   "
234874|NCT00921908|"     Postoperative administration of local anesthetics is effective for postoperative pain     management across surgical specialties but the optimal type of catheter (single, few or     multiholed catheters) has not been determined.      This study investigates wound spread of a radioactive isotope (technetium) administered in     different types of catheters after total hip arthroplasty.   "
234875|NCT00921921|"     Chronic obstructive pulmonary disease or 'COPD' is a chronic disease, which means that it     cannot be cured, but that inhalers and tablets can be used to control the symptoms. In COPD,     the airways become inflamed which can cause coughing and make the airways tighten. This     'inflammation' is the root of the problem in COPD.      The airways of the lung start in the windpipe and branch like the branches of a tree, getting     smaller and smaller. In COPD the inflammation is deep in the lungs, out to the very small     airways.      Different inhalers make the medicines into different sized particles. Most steroid inhalers     used for COPD make the medicine into particles which are too big to get into the very small     airways ('coarse particles'). Other inhalers make a mist, with much smaller particles ('fine     particles'). These are as small as the smallest airways in the lungs.      Doctors have recently found a way to measure the inflammation in the small airways that are     affected in COPD. The investigators want to find out if taking one of these 'fine-particle'     steroid inhalers can treat that inflammation.   "
234876|NCT00921934|"     Chronic viral infections induce oxidative stress that can cause a number of concomitant     diseases, e.g. cardio-vascular diseases or metabolic disorders. Therefore, a sufficient     treatment of oxidative stress may be of benefit for the patient to prevent further diseases.      Shingles (herpes zoster infection) have been successfully treated with antioxidative     substances like high-dose vitamin C for ages. Not only the acute symptoms can be diminished     by high-dose vitamin C. Even long-term sequelae, like painful post-herpetic neuropathy, may     be mitigated or even fully avoided.   "
234881|NCT00921999|"     Background:        -  The common varicella-zoster virus causes both chickenpox and shingles. Both diseases          cause rashes, but they can also have complications such as bacterial infections of the          skin, pneumonia, or eye disease.        -  By drawing and studying blood samples from people who have been infected with the          varicella-zoster virus or who are receiving or have received the varicella vaccine,          researchers hope to learn more about the immune system s response to the virus.      Objectives:      - To determine the immune system s response to the varicella virus, either in its existing     form or given as part of a vaccine.      Eligibility:        -  Individuals 18 years of age and older who have had or are receiving the varicella          vaccine.        -  Individuals 5 years of age and older who currently have chickenpox or shingles.      Design:        -  Participants will visit the NIH Clinical Center for an initial physical examination, and          will provide blood samples for evaluation.        -  Researchers will determine the number of samples to be taken and the amount of blood to          be drawn as needed based on the participants medical history and exposure to the          varicella-zoster virus.      Investigators in this study will not be giving subjects either the chickenpox or shingles     vaccine. They will only be looking at the response to the vaccine in persons who are     receiving or have received the vaccine from their health care provider.   "
234898|NCT00922220|"     The purpose of this study was to determine the immediate effect of 3 common physical therapy     interventions for people experiencing low back pain on the perception of thermal pain.     Additionally, the investigators wished to determine the influence of psychological factors     related to fear and anxiety on their findings and to determine whether the effects of the     individual interventions were local (specific to the area of application) or global     (influenced regions away from the area of application).   "
234899|NCT00922233|"     A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and     acceptability of pericoital oral contraception with levonorgestrel   "
234900|NCT00922246|"     To address whether custom made foot insoles could be used for primary prevention of lower     limb overuse injuries, the investigators conducted a prospective, randomized controlled study     comparing the use of insoles and standard shoes in healthy young adults exposed to increased     physical activity.   "
234882|NCT00922012|"     In 1995 the National Institutes of Health-National Institute of Diabetes and Digestive and     Kidney Diseases (NIDDK) workshop reached a consensus on the definition and classification of     prostatitis syndromes.The commonest and yet most poorly understood of these prostatitis     syndromes is category III or chronic pelvic pain syndrome (CPPS). It has been shown that,     while men with CPPS have significantly higher leukocyte counts in urine and expressed     prostatic secretions compared with age matched controls, inflammation and infection do not     necessarily correlate with symptom severity.      The lack of a direct relationship between inflammation and symptoms is supported through     studies of prostate histopathology, in which moderate or severe inflammation was identified     in only 5% of men with CPPS.Conventional treatment has focused on long, empirical courses of     expensive broad-spectrum antibiotics, mostly of the quinolone class, with or without the     concomitant use of an α-blocker and anti-inflammatory agents. At the turn of the 19th century     stimulation with electrical current and changing magnetic fields was used to treat surface     conditions associated with intractable pain, such as painful malignant ulcers. The analgesic     benefits of pulsed electromagnetic fields for relieving pelvic pain has been investigated in     women with tissue trauma and chronic refractory pelvic pain.Despite its uncertain etiology     there is some evidence that the symptom complex found in CPPS may be founded at least in part     in pelvic floor muscular dysfunction and/or neurogenic hypersensitivity/inflammation.      We hypothesized that the application of a electromagnetic stimulation to the perineum of the     subject may result in neural excitation and pelvic floor muscle stimulation to a degree that     breaks the cycle of tonic muscular spasm and neural hypersensitivity/inflammation, thereby,     restoring more normal pelvic floor muscular activity.   "
234883|NCT00922025|"     The objective is to investigate the correlation between smoking pattern and clinical efficacy     of EGFR TKIs in male patients with locally advanced or metastasized non-small cell lung     cancer of adeno histology who have failed 1st line chemotherapy. Health care resource usage,     quality of life (EQ-5D) and practice of EGFR mutation test will also be evaluated. Current     practice of EGFR mutation testing in Taiwan will be surveyed.   "
234884|NCT00922038|"     This project evaluates the effect of a combined economic and psycho-social intervention to     reduce risky sexual activity and its consequences. The main hypothesis to be tested is that     risky sexual activity and resulting sexually transmitted infections (STIs) can be reduced     through an intervention of counseling, regular STI testing, and positive reinforcement using     cash rewards. The intervention is being implemented in a population of young people in rural     Tanzania where more conventional behavioral change interventions have had limited effect in     battling a generalized HIV epidemic.   "
234885|NCT00922051|"     The objective of this study is to investigate the effectiveness of Acu-TENS (transcutaneous     electrical nerve stimulation applied on acupoints) on lung functions, dyspnoeic symptoms and     its association with beta endorphin level in subjects with COPD.   "
234886|NCT00922064|"     In treatment-resistant depression, electroconvulsive therapy (ECT) has been shown to     effectively reduce depressive symptoms, though the underlying neurobiological mechanism is     still unclear. The serotonergic system, and in particular the inhibitory serotonin-1A     (5-HT1A) receptor, appears to be significantly involved in the effectiveness of ECT. The aim     of the study is to assess the effects of ECT on the 5-HT1A receptor binding potential (BPND)     and distribution in humans in vivo using positron emission tomography (PET) and the     radioligand [carbonyl-11C]WAY-100635.      12 patients suffering from severe, therapy-resistant unipolar depression will undergo 3 PET     scans, two of these scans taking place before the ECT treatment, consisting of 6-14 ECTs, the     third scan taking place after the ECT treatment.      This imaging study hypothesizes that upon completion of the ECT, the overall 5-HT1A receptor     BPND in the brain of depressed patients will significantly change.      This study would be the first to demonstrate an effect of electroconvulsive therapy on the     5-HT1A receptor binding in humans in vivo. Given the involvement of the 5-HT1A receptor in     the pathophysiology of mood disorders, the present study would be an important step towards a     better understanding of antidepressant treatment and treatment response. By comparing     treatment effect and the underlying biological mechanism, the study might help to identify     biomarkers that distinguish patients who are likely to benefit from ECT from patients who     will rather be non-responders. Finally, by investigating the role of the 5-HT1A receptor in     ECT, is highly discussed relevance for antidepressant action will be further elucidated and     might prepare the ground for new therapeutic strategies.   "
234887|NCT00922077|"     The purpose of the study was to evaluate this therapeutic intervention by expressing     functional level with valid quantitative data.   "
234888|NCT00922090|"     The primary objective of this NIS is to assess the clinical benefit subjects derive from     taking seroquel XR, using the CGI-CB. The secondary objective is to assess the     effectiveness,safety and tolerability of seroquel XR tablets.   "
234889|NCT00922103|"     For patients with ulcerative colitis, eligible for surgical treatment, which restorative     surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo     rectal anastomosis is the best in terms of complications, functional outcome and health     status and quality of life.   "
234890|NCT00922116|"     This single arm study will assess the efficacy, safety and tolerability of once monthly     administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients     with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose     of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA     previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels     within the target range. The anticipated time on study treatment is 3-12 months, and the     target sample size is 100-500 individuals.   "
234896|NCT00922194|"     The study included 102 overweight type 2 diabetes mellitus patients with a body mass index     (BMI) of more than 25 in an open label study. They were advised intensive life style     modification which was reinforced at each follow-up visit. In addition they were prescribed     extended release metformin (XR) in a gradually increasing tolerable dose, starting with 0.5g     twice a day after meals. In addition, hypertension and dyslipidemia, when present, were     treated with appropriate recommended drugs. Those who completed a satisfactory regular     follow-up for at least 12 months or more were then analyzed for changes in their     anthropometric measurements and glycemic control.   "
234897|NCT00922207|"     This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with     Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be     randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4     to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or     3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment     will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study     treatment is 1 year, and the target sample size is 100-500 individuals.   "
234901|NCT00922259|"     Every year the human population suffers from seasonal outbreaks of influenza resulting in     both illness and death. However, the rates of illness and death from seasonal outbreaks are     significantly lower than those suffered during times of influenza pandemic, such as those     experienced in 1918, 1957, and 1968. The reason for this difference lies in presence of     immunity within a population. With seasonal outbreaks of influenza most people have some     immunity to the circulating strain and usually only those with weakened immune systems     experience serious complications. Influenza pandemics, in contrast, are the result of a     completely new viral subtype to which nobody possesses an immunity, leaving everyone     vulnerable to the most serious of complications.      It has been estimated that the next flu pandemic could cause over 200,000 deaths and over     700,000 hospitalizations in the US alone. The need for an effective viral vaccine is high.     The purpose of this study is to test the safety and immunogenicity of a live influenza A     strain vaccine, which would be able to combat an influenza pandemic.   "
234902|NCT00922272|"     To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical     antipsychotic medication, on negative symptoms in adult subjects with clinically stable     schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment     of Negative Symptoms (SANS).   "
234903|NCT00922285|"     RATIONALE: Art therapy may help relieve emotional distress in caregivers of young patients     undergoing bone marrow transplant for cancer.      PURPOSE: This clinical trial is studying art therapy for caregivers of young patients     undergoing bone marrow transplant for cancer.   "
234904|NCT00922311|"     Study objective: To investigate the potential anti-proteinuric efficacy of aliskiren, a novel     direct renin inhibitor (DRI), in addition to angiotensin receptor blocker (ARB) in     immunoglobulin A nephropathy (IgAN) patients at risk of developing progressive renal failure.   "
234905|NCT00922324|"     The study will assess the safety, tolerability and fecal shedding of STP206 when given as a     single dose and when given as daily doses for one week.   "
234906|NCT00922337|"     the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical     Performance of the InspireMD MGuard Coronary Stent System   "
234907|NCT00922350|"     The purpose of this study is to verify that nebulization with bronchodilators associated with     heliox gas (helium + oxygen) and the posture of a leaning forward truck is effective in     patients with an asthma attack.   "
234908|NCT00922363|"     The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg     Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four     groups of healthy volunteers, injecting two doses with two months interval.   "
234909|NCT00922376|"     New telemedicine systems have been designed to assist people suffering from diabetes in the     management of their chronic disease. More recently the focus has been moving to portable     systems equipped with Bluetooth. This study consists of evaluating an application called the     Think Positive (T+) diabetes management software. It is a randomized controlled trial     designed to compare, over a nine month period, a group of patients receiving usual care with     a group of patients using the T+ system. The objectives of the study are to investigate the     extent to which this telemedicine application helps patients control their blood sugar levels     (HbA1c), as well as the extent to which its users consider it to be acceptable. The impact of     its use on factors such as diabetes self-care, health status, quality of life,     self-confidence in diabetes management, fear of hypoglycemia and illness representations will     also be examined. Because of the supplementary real-time support and feedback that T+ offers,     its use should lead to better outcomes in diabetes management than usual care does.   "
234910|NCT00922389|"     The purpose of this study is to determine whether the method (implanting stem cells derived     from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the     management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by     improving blood circulation in ischemic limb which would in turn promote ulcer healing,     prevent amputation of limb and relieve the Sevier pain of ischemia.   "
234911|NCT00922402|"     The main purpose of this study is to validate an intensive protocol of insulin infusion and     subsequent subcutaneous insulin administration with the support of continuous glucose     monitoring, in addition to reference finger-stick values.   "
234912|NCT00922415|"     our primary objective is to correlate fecal calprotectin with currently used Crohn's disease     endoscopic disease activity scores used for predicting endoscopic recurrence. Our secondary     objectives will be to determine a cutoff for early macroscopic recurrence of disease based on     surveillance colonoscopies , and to compare this with other surrogate markers .   "
234913|NCT00922428|"     The purpose of this observational study is to give an overview of the use of PASCOE-Agil     HOM-Injektopas in a 2-4 week treatment of rheumatic disorders.   "
234914|NCT00922441|"     The purpose of this study is to evaluate the antihypertensive efficacy and safety of     Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential     hypertension.   "
234915|NCT00922454|"     The purpose of this study is to compare acute technical outcomes of the Talent AAA Stent     Graft system versus Cook Zenith Endograft at two high volume institutions, Albany Medical     Center and St. Peter's Hospital in Albany, NY.      The investigators are comparing the two devices as part of the evolution of endovascular     repair (EVAR) for AAAs. The Zenith AAA Endovascular Graft received FDA approval on May 23,     2003, the Talent Abdominal Stent Graft System on April 15, 2008.   "
234916|NCT00922467|"     Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol     and remifentanil   "
234917|NCT00922480|"     The purpose of this study is to evaluate the antihypertensive efficacy and safety of     Fimasartan (BR-A-657•K) 60 mg~120 mg in patients with mild to moderate essential     hypertension.   "
234929|NCT00922636|"     The primary purpose of your child's participation in this study is to determine whether     LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD);     and assess the safety of LY2216684 and any side effects that might be associated with it.   "
234930|NCT00922649|"     16-week, open-label, multi-center pilot study. Insulin pump naïve subjects with type 2     diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established     regimen of either: 1) ≥ 2 OAs (Cohort A), 2) basal insulin ± OAs (Cohort B), or 3)     basal-bolus insulin ± OAs (Cohort C) will initiate basal-bolus therapy with an insulin pump     using a rapid-acting insulin analog.   "
234918|NCT00922493|"     Background: the objective of the present inquiry was to evaluate the weaning process in     intubated older people subjected to inspiratory muscle training and to correlate the     predictors of ventilatory interruption with its success.      Methods: the patients were divided randomly into an experimental group (EG, n=14; age=82±4     years) that received conventional physiotherapy plus inspiratory muscle training (IMT) with     threshold IMT® and a control group (CG, n=14; age=81±6 years) that received only conventional     physiotherapy. The predictors evaluates were the maximum inspiratory pressure (MIP) and the     index of Tobin (IT). The protocol for muscle training consisted of an initial load of 30%     MIP, which was increased by 10% daily; training was administered for five minutes, twice a     day, seven times a week with supplemental oxygen for the entire period from the decision to     wean up to extubation.   "
234919|NCT00922506|"     OAB occurs in approximately 50% to 75% of men with BPO and up to 38% of men with BPO continue     to suffer from OAB after relief the obstruction.Symptoms of OAB are more bothersome than the     voiding complaints of slow stream and hesitancy. However, the patients with both BPO and OAB     are often not treated with muscarinic receptor antagonists due to concern that they will     experience acute urinary retention.      Tolterodine is a potent and pure muscarinic receptor antagonist that was developed     specifically for the treatment of overactive bladder. Recently, studies revealed that     tolterodine was effective, safe and well tolerated in adults with OAB and urodynamically     confirmed BPO.However, the optimal dosage of antimuscarinic for the treatment of OAB     coexisting BPO was not yet fully assessed. In real clinical situation, some patients complain     voiding difficulty after addition of antimuscarinics and want to stop antimuscarinics.It is     probable that a lower dosage of antimuscarinics combined with alpha-adrenergic antagonists     can be used safely in OAB patients with BOO, with the same efficacy.      This study is designed to investigate the optimal doses of tolterodine SR in combination with     doxazosin in men with both BOO and OAB based on efficacy, safety, and tolerability.   "
234920|NCT00922519|"     This study is being done to provide an alternative to bone scanning with technetium-99m     (99mTc) labelled diphosphonates, and to document the safety of {18F}-Sodium Fluoride (Na18F)     as a Positron Emission Tomography (PET) imaging radiopharmaceutical. Since the current     availability of 99mTc was severely reduced because of the Chalk River shut down, alternative     approaches to done scanning are needed. PET imaging with Na18F is one alternative approach to     providing this critical clinical service.   "
234921|NCT00922532|"     This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm     the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure     associated with pulmonary hypertension in preterm infants.      Study subjects will be administered either inhaled nitric oxide or placebo to determine if     there is a change in oxygenation.   "
234922|NCT00922545|"     Main objective:      Evaluate the effectiveness of a combined strategy addressed to health care workers and     patients, in relation to improving clinical control and patient's quality of life.It includes     a feed-back about the health status of the patients, an education plan addressed to     practitioners based in a CPG and in health education   "
234923|NCT00922558|"     Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of     electronic signals emitted by four footplates, one for each heel and toe, respectively. These     are sensitive to vertical pressure produced by a subject standing straight but in various     positions (feet parallel, in tandem, eyes closed, on pads, etc.). The method yields     additional parameters not obtained by the traditional monoplate stabilometers, namely,     weight-distribution patterns and correlation among six combinations of paired outputs from     the two heels, two toes, heel/toe of each foot, and the two diagonals (tetra-ataxiametric     synchronizations). Comparing age-matched learning disabled, mentally retarded, autistic, and     hearing impaired (with and without labyrinthine hypofunction) with normal children,     significant and clinically meaningful differences were detected between the     Tetra-ataxiametric measures of stability, interaction between Fourier Spectral Power Ranges     of body sway, weight distributions, and synchronizations of toe parts. The same parameters     correlated significantly with cognitive school readiness in normal populations. While the     stability and spectral quotients show significant developmental changes, weight distribution     and toe synchronisations are stable from 5 years onwards. The method is suitable for young     subjects and attractive to children who may ordinarily be reluctant to cooperate, such as the     autistic ones. The equipment is portable and tests can be conveniently carried out in a     child's familiar educational setting.   "
234924|NCT00922571|"     The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser     System to perform surgical maneuvers during cataract extraction surgery.   "
234939|NCT00922766|"     To collect data on safety and effectiveness of dalteparin in the management of non-ST segment     elevated acute coronary syndromes in nursing home patients who will be treated conservatively     (without percutaneous corornary intervention [PCI] or coronary artery bypass graft [CABG]     within 48 hours).   "
234925|NCT00922584|"     This trial's aim is to evaluate the efficacy and toxicity of sorafenib in relapsed advanced     Non-Small Cell Lung Cancer (NSCLC) after failure of epidermal growth factor     receptors-tyrosine kinase inhibitor (EGFR-TKI) treatment and to explore the correlation     between clinical outcomes and biochemical modulation of signal transduction pathways.   "
234926|NCT00922597|"     The objective of this international post-marketing surveillance study is to collect data on     the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.   "
234927|NCT00922610|"     This study will assess the efficacy and safety of once monthly administration of Mircera in     Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and     not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting     dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin     level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study     treatment is 3-12 months, and the target sample is <100 individuals.   "
234928|NCT00922623|"     This is a study to assess how safe and effective an investigational product, Belotero® is in     people with all skin types with facial wrinkles, such as nasolabial folds. Nasolabial folds     are wrinkles on the face that go from outside of the nostrils to the edges of the mouth.   "
239433|NCT00982449|"     This research is being done to determine whether viral thymidine kinase (TK) expression in     Epstein-Barr virus (EBV) and Kaposi's sarcoma herpesvirus (KSHV) virus-associated tumors is     sufficient to image.   "
234932|NCT00922675|"     Study objectives: To assess the effects of postconditioning on infarct size in patients with     ST-elevation infarction referred to PCI.      Study design: Prospective, randomized, open-label study with blinded endpoint evaluation.     Included patients will be randomly allocated to postconditioning or control. Patients with     symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ECG criteria     for primary PCI are eligible. PCI follow established routines. In postconditioning patients,     additional, short (1 min), intermittent balloon occlusions will be applied after initial     opening of infarct related artery. After this intervention, PCI proceeds routinely with stent     implantation. In the control group, stent implantation after initial opening proceeds as     usual. Primary endpoint is final infarct size, determined by MRI after 4 months. 260 patients     will be included. Follow-up is 1 year. Inclusion period: 18 - 24 months.      Clinical implications: Reperfusion therapy, administered as early as possible after start of     symptoms, has improved the prognosis in acute ST-elevation myocardial infarction. Still,     however, many patients suffer large infarctions, subsequently with an increased risk of heart     failure, arrhythmias, and death. In pilot studies, mechanical postconditioning has been shown     to reduce infarct size and thus potentially improve prognosis. However, the effect of     postconditioning must be confirmed in larger clinical trials before implemented in routine     treatment.   "
234933|NCT00922688|"     Rationale: It is well known that insulin resistance occurs after mediocre and intensive     surgery, such as colon cancer surgery. Disturbances in insulin action negatively affect the     postoperative recovery, either by prolonging the capacity of the body to regain normal     function, or by increasing the metabolic stress and the risk for complications. Several     studies have shown that focusing therapies on improving insulin resistance is successful.     Experimental studies have shown that antioxidant agents, like glutamine (a precursor of     glutathione), improve insulin sensitivity. The hypothesis of this study is that perioperative     parenteral or enteral administration of glutamine, given as the dipeptide alanyl-glutamine,     will reduce or prevent postoperative insulin resistance in colon cancer patients. The study     will also be focused on the different routes of administration, because of the expected     differential metabolic effects.      Objective: The investigators' primary objective is to study whether intravenous or enteral     administration of the dipeptide alanyl-glutamine will reduce or prevent postoperative insulin     resistance in colon cancer patients.      Study design: A double-blinded, placebo controlled randomised, pilot study at the Surgery     Department of the Medical Center Alkmaar.      Study population: Thirty patients of male gender and any ethnicity, who will undergo elective     open abdominal colon surgery for colon cancer, aged 18-75 years.      Intervention: Patients will receive dipeptide alanyl-glutamine intravenously or enterally,     starting 24 hours prior to surgery, until 24 hours after surgery in the dosage of 0.5     g/kg/day, or saline (control group), for the same period of time.      Main study parameters/endpoints: The main study parameter is postoperative insulin     resistance. Secondary study parameters are lipolysis, oxidative stress and glucoregulatory     hormones. Muscle, liver and fat biopsies will be taken to study insulin sensitive as well as     inflammatory pathways.   "
234934|NCT00922701|"     The development of glucose-sparing strategies able to provide an efficacious ultrafiltration     profile represents one of the modern goals of peritoneal dialysis therapy. The study     hypothesis is to evaluate the possibility to formulate peritoneal dialysis solutions     containing L-carnitine as an osmotic agent to partially replace glucose.   "
234935|NCT00922714|"     This is a prospective double-blinded placebo-controlled block randomized study in intensive     care patients comparing intravenous glutamine supplementation to placebo. The hypothesis is     an improvement of clinical outcome. The primary endpoint is a reduction in the Sequential     Organ Failure Assessment (SOFA) score on day 7 of treatment.   "
234936|NCT00922727|"     This study will evaluate the safety and tolerability of the probiotic Lactobacillus reuteri     (LR) in healthy adult patients. Patients will be randomized to receive either LR or placebo     orally each day for a total of 60 doses. The effects on fecal bacteria, circulating white     blood cell receptors and inflammatory cytokine profiles will be measured.   "
234937|NCT00922740|"     The main purpose of the study is to evaluate the way VA106483 enters and leaves the blood and     tissues over time and how the drug acts on and in the body at various dose levels compared to     placebo in the same volunteer.   "
234938|NCT00922753|"     Preoxygenation optimizes oxygen content in the functional residual capacity (FRC). Adequate     preoxygenation is defined by an expiratory oxygen fraction (FEO2) > 90%. Inspiratory support     and positive end expiratory pressure (PEEP) can create a better reservoir, improve gas     exchange and shorten the time needed for adequate preoxygenation. The goal of the study is to     evaluate the efficacy and tolerability of different levels of inspiratory support and     positive end expiratory pressure during preoxygenation in healthy subjects.   "
234940|NCT00922779|"     This single arm study will evaluate the safety and tolerability of ribavirin in combination     with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or     1000-1200mg po daily, according to HCV genotype and body weight (< and >75kg)in combination     with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months,     and the target sample size is >500 individuals.   "
234941|NCT00922792|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting     activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.   "
234942|NCT00922805|"     Short bowel syndrome (SBS) is a form of disease that results from removal of a significant     portion of the intestine leading to poor nutrient absorption. Infants with short bowel     syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the     lack of effective therapies.      Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits     and vegetables. Soluble fiber can reduce the severity and duration of persistent (constant)     diarrhea in children.      The purpose of this research study is to evaluate the many effects of fiber added in the diet     of infants with SBS   "
234943|NCT00922818|"     Our objective is to evaluate the clinical outcomes for the anatomic radical perineal     prostatectomy (RPP) for the surgical management of prostate cancer. We will report the     perioperative, oncologic, and functional outcomes in patients undergoing the radical perineal     prostatectomy at our institution.   "
234944|NCT00922831|"     The purpose of this study is to look at multiple sclerosis patients process of awareness,     learning, and judging status over a 3 year time period.   "
234945|NCT00922844|"     Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood     pressure and systemic vascular resistance.   "
234955|NCT00922974|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This randomized phase II/III trial is studying how well image-guided radiosurgery or     stereotactic body radiation therapy works and compares it to external-beam radiation therapy     in treating patients with localized spine metastasis. (phase II completed as of 8-30-11)   "
234946|NCT00922857|"     The prevalence of chronic respiratory failure (CRF) is increasing worldwide and will become     the 3rd cause of death by 2020. At the stage of the disease requiring ventilatory assistance,     this relates to 50,000 patients in France, life expectancy is very limited, and quality of     life is poor.      CRF led to a reduction in muscle mass, which is found in 35 and 55% of patients, in some to a     profound cachexia. A reduced fat free mass (FFM) is a factor associated with a poor tolerance     to exercise and an halved survival. The exact causes and mechanisms leading to cachexia are     not yet established. Recently, a chronic inflammatory condition has been quoted as a putative     cause. This chronic inflammation would involve the molecular mechanisms leading to poor     regulation of the balance of synthesis / protein degradation in muscle. A decrease in plasma     and muscle amino acids was found among patients with a low FFM.. In addition, a decrease of     plasma levels of some anabolic hormones, GH and androgens or IGF-1 has been found that could     explain a lack of protein synthesis.      It is now well established that respiratory rehabilitation, including a program of exercise     reconditioning, increases tolerance to exercise and improve the quality of life. Besides the     classical type of endurance exercises stimulating the cardio-respiratory system, it is     suggested to add resistance exercises. Several studies have reported the benefit of this     strategy but the link with intracellular molecular pathways has not been described; moreover,     it is unknown whether the existence of an initial muscular atrophy influences the gain in     muscle strength/mass.   "
234947|NCT00922870|"     Septic shock is a major cause of mortality and morbidity in critically ill patients. Septic     Shock is associated with an overwhelming, systemic overflow of pro inflammatory and     anti-inflammatory mediators, which leads to generalized endothelial damage, multiple organ     failure, and altered cellular immunological responsiveness. Although our understanding of the     complex pathophysiological alterations that occur in septic shock has increased greatly as a     result of recent clinical and preclinical studies, mortality associated with the disorder     remains unacceptably high, ranging from 30% to 50%. To date, attempts to improve survival     with innovative, predominantly anti-inflammatory therapeutic strategies have been     disappointing. A standard hemofiltration rate of 35 ml/kg/hour has been successfully used to     treat acute renal failure. However, this dose does not alter plasma levels of inflammatory     mediators, suggesting that its ability to clear these mediators is suboptimal. Higher doses     of hemofiltration (up to 120 ml/kg per hour) have been demonstrated to improve cardiac     function and hemodynamics in several animal models of sepsis. High-volume hemofiltration     (HVHF) was thus conceived and applied in patients with septic shock, showing an improvements     in hemodynamics with decreased vasopressor requirements and improved survival in patients     admitted after a cardiac arrest.      The main benefit described with high volume hemofiltration is a hemodynamic improvement (e.g     reduction in catecholamines' requirement). This improvement seems to be due to the removal of     a badly defined network of middle molecular weight peptides. To remove efficiently these     middle molecular peptides, a high filtration rate is needed. However, with high filtration     rates, there is also a high clearance for smaller molecules, including antibiotics,     electrolytes, vitamins, trace elements and amino acids.      The cascade hemofiltration system has been designed for a more efficient removal of middle     molecular weight peptides with a limited solute consumption.      The goal of this study is the evaluation of the hemodynamic improvement using cascade     hemofiltration in patients treated for septic shock.   "
234948|NCT00922883|"     Severe aplastic anemia (SAA) is a life-threatening blood disease which can be effectively     treated with immunosuppressive drug regimens or allogeneic stem cell transplantation.     However, 20-40% of patients without transplant options do not respond to immunosuppressive     therapies, and have persistent severe thrombocytopenia. Even patients that respond to     immunosuppressive therapies with an improvement in their life-threatening neutropenia     sometimes have persistent thrombocytopenia. Both groups of patients (i.e. nonresponders to     immunosuppressive therapy and responders with persistent thrombocytopenia) require regular     platelet transfusions, which are expensive and inconvenient, and are a risk for further     serious bleeding complications.      Thrombopoietin (TPO) is the principal endogenous regulator of platelet production. On binding     to the megakaryocyte progenitor TPO receptor, TPO initiates a number of signal transduction     events to increase the production of mature megakaryocytes and platelets. Thrombopoietin also     has stimulatory effects on more primitive multilineage progenitors and stem cells in vitro     and in animal models. A 2nd generation small molecule TPO-agonist, eltrombopag (Promacta )     has been shown to increase platelets in healthy subjects and in thrombocytopenic patients     with chronic immune thrombocytopenic purpura (ITP) and hepatitis C virus (HCV) infection.     Eltrombopag is administered orally and has been well-tolerated in clinical trials. Unlike     recombinant TPO, it has not been found to induce autoantibodies. Eltrombopag received FDA     accelerated approval on Nov 20, 2008 for the treatment of thrombocytopenia in patients with     chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to     corticosteroids, immunoglobulins, or splenectomy. Because a paucity of megakaryocytes and     decreased platelet production is responsible for thrombocytopenia in aplastic anemia     patients, we now propose this Phase 2, non-randomized pilot study of eltrombopag in aplastic     anemia patients with immunosuppressive therapy refractory thrombocytopenia.      Subjects will initiate study medication at an oral dose of 50 mg/day (25 mg/day for East     Asians), which will be increased or decreased as clinically indicated to the lowest dose that     maintains a stable platelet count 20,000/(micro)L above baseline while maximizing     tolerability. Treatment response is defined as platelet count increases to 20,000/(micro)L     above baseline at three months. Subjects with response at 3 months may continue study     medication (extended access) until they meet an off study criteria.   "
234949|NCT00922896|"     The purpose of this study is to determine the response rate of gemcitabine, cisplatin and     erlotinib in metastatic pancreatic cancer.   "
234965|NCT00928772|"     Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without     excessive drowsiness in preoperative settings.   "
234950|NCT00922909|"     Different results have recently led to question the classical notion according to which the     motor and cognitive deficits in Parkinson's disease are tied to a thalamo-cortical inhibition     due to the degeneration of the dopaminergic nigro-striatal pathways. Instead, Parkinsons's     disease seems accompanied by an increase in motor cortical activity.      A reaction time task, known as the Simon task in the literature, allows one to study the     influence of irrelevant visual information on decision making. In the most common version of     this task (used in the prosed study), the subjects have to choose between a left- and a     right-hand keypress according to the color of a visual signal presented either to the left or     to the right of a fixation. The to be established association is said congruent when the     response is ipsilateral to the stimulus and incongruent when the response is contralateral     to the stimulus. In healthy volunteers, EMG investigations have revealed that in a     significant numbers of trials, the contraction of the response agonist is preceded by a     infra-liminal contraction of the agonist involved in the non-required response. Such partial     errors demonstrate that the nervous system is able to detect, abort and correct a part of     its errors, thereby revealing the existence of an on-line executive control in simple     decision tasks. Behavioral studies performed in Parkinson disease patients, suggest that     these patients may experience a deficit in such a control.      The present study aims at testing this hypothesis by assessing the effect of subthalamic     stimulation on the patients' performance in a Simon task.   "
234952|NCT00922935|"     Comparison of early and late loading of implants supporting full each prosthesis in upper     jaw, using the Cresco prosthetic system on Straumann implants. The study hypothesis is that     there is no difference between the bone loss (or gain) between the groups.   "
234953|NCT00922948|"     The purpose of this study is to verify the oncological efficacy and safety of cryoablation     and radiofrequency ablation for the treatment of small renal tumors.   "
234960|NCT00928707|"     This is a multicentre, randomized, open-label, phase II study testing GIVINOSTAT (ITF2357) in     combination with hydroxyurea in a population of patients with JAK2V617F positive Polycythemia     Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3     months.      Recruited patients will be randomly assigned to one of the following treatment groups:        -  group A: 50 mg o.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum          tolerated dose of hydroxyurea monotherapy already in use before admission to the study;        -  group B: 50 mg b.i.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum          tolerated dose of hydroxyurea monotherapy already in use before admission to the study.      The two groups will be balanced for number and for Centre in order to provide valuable     information on both treatment regimens.      In both groups assigned doses shall remain stable until week 12, which is when the primary     endpoint is assessed, unless specific tolerability issues arise which impose dose reduction.      After the primary endpoint assessment at week 12, one of the following treatment schedules     will be chosen case by case on the basis of the achieved clinical response and continued for     up to 12 further weeks:        -  Partial or Complete Response at week 12:        -  group A: continue 50 mg o.d.;        -  group B: continue 50 mg b.i.d.;        -  No Response at week 12:        -  group A: increase to 50 mg b.i.d.;        -  group B: increase to 50 mg t.i.d.. At any time during study course, if toxicity is          observed, GIVINOSTAT (ITF2357) treatment will be discontinued until recovery and then          restarted at a reduced dose level. The drug will be definitively withdrawn in case of          reappearance of toxicity even at a reduced daily dose. Overall, the treatment will last          up to a maximum of 24 cumulative weeks of drug administration.      The study will recruit subjects of both genders with an established diagnosis of JAK2V617F     positive Polycythemia Vera according to the revised WHO criteria, in need of cytoreductive     therapy, non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least     3 months.   "
234961|NCT00928720|"     The purpose of this study is to determine the effects of mild cranial electrical stimulation     on pain, fatigue, sleep disturbances, perceived stress, blood pressure, and functional status     in persons with fibromyalgia.   "
234962|NCT00928733|"     Alcohol consumption is a major health problem worldwide. It affects all systems of the body     especially the gastrointestinal tract. Acute or chronic alcohol consumption has deleterious     effects on the gastrointestinal mucosa vary from increased intestinal permeability,     structural changes to sever destruction of the epithelial lining cells. Human data are still     limited and most of the studies were performed in chronic alcohol abusers.      The investigators hypothesize that moderate alcohol drinking also may increase small     intestinal permeability and contribute to the subsequent disruption of the tight junction     complex. This study may provide more insight into the effects of moderate alcohol drinking on     the small intestinal permeability.   "
234963|NCT00928746|"     The primary objective of this study is to evaluate the performance, accuracy, and handling of     the actuation indicator in patients with COPD. The actuation indicator is integrated into     mouthpiece of the ipratropium bromide HFA inhalation aerosol device. As part of Boehringer     Ingelheim's program to qualify an actuation indicator for use with the ipratropium bromide     HFA inhalation aerosol device, this study is intended to complement the results from the     ongoing in-vitro studies.   "
234964|NCT00928759|"     The purpose of this study is to learn if obese pre- and early pubertal girls with     hyperandrogenemia (HA) are more insulin resistant (i.e., have lower insulin-stimulated     glucose disposal) compared to obese peripubertal girls without HA; and that overnight mean     luteinizing hormone (LH) concentration is also an independent predictor of free testosterone     concentrations, especially in mid- to late pubertal girls.   "
234967|NCT00928798|"     The purpose of the study is to determine whether topical application of rapamycin can lead to     reduction in size and/or number of fibrofolliculomas in BHD patients and may prevent the     growth of new ones. Secondary we evaluate rapamycin safety, formula acceptance and patient     satisfaction.   "
234968|NCT00928811|"     The study is undertaken to explore the safety of using Simulect at monthly dose intervals to     reduce the need of high dose/level CNI's such as Prograf.   "
234969|NCT00928824|"     The purpose of this study is to determine whether traditional japanese diet blood pressure in     healthy volunteers.   "
234970|NCT00928837|"     The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with     Naproxen and placebo in OA of the knee.   "
234971|NCT00928850|"     This study aims to determine whether surgeons at Memorial Sloan-Kettering Cancer Center are     able to randomize patients to test modifications of surgery to remove the prostate. Surgery     to remove the prostate is known as a radical prostatectomy. Surgeons know many things about     the best way to do a radical prostatectomy. However, there is disagreement about some aspects     of surgery. Two modifications of surgery to remove the prostate (radical prostatectomy)     identified for this study include Irrigation, and Fascial Suturing.      Two aspects of the operation may vary, fascial suturing and urethral irrigation. For each     aspect, surgeons will use their clinical judgment as to the best interests of the patient. In     other words, if there are clear reasons to use or avoid a fascial suturing approach, the     surgeon will act accordingly; similarly, if there is a clear reason to irrigate or avoid     irrigating the urethra, the surgeon can make the appropriate clinical decision. If the     surgeon is unsure as to which approach to take, then the randomization scheme will be     followed.      All of the surgeons who are taking part in this study have used these techniques at different     times. However, they are unsure as to the best approach. Sometimes, they use different     treatments with different patients.      Irrigation. Cancer cells can spill during surgery and this can cause cancer to return     (recur). Some surgeons believe that irrigating could help stop spilling of cancer cells.     Irrigating means washing the surgical area with sterile water and sucking the water back up     through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will     examine irrigation of the urethra. This is the part of the body that carries urine from the     bladder to the penis.      Fascial suturing. Surgeons believe that what happens to the urethra can affect the risk of     incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea     is that additional stitches (sutures) to the connective tissue (fascia) could be helpful,     but this is not known for sure.   "
234972|NCT00928863|"     The objectives of this study is first to asses to what extent the guidelines of the Dutch     Society of Obstetrics and Gynaecology (NVOG) and the MOET (Management of Obstetric and     Emergencies and Trauma) instructions for haemorrhagia postpartum have been implemented in     current care in the Dutch practice. Second to study barriers and facilitators for guideline     adherence and to develop and test a tailored implementation strategy, based on these     findings.   "
234973|NCT00928876|"     Obesity is characterized by continuous low-grade inflammation. This is an important link     between obesity and insulin resistance.      Results from the investigators' own group of in vitro and in vivo research on mice show that     Interleukin-1 is involved in the process of developing insulin resistance. Earlier it has     been shown that interleukin-1 receptor antagonist in human subjects improves glycemic     control. The investigators' hypothesis is that this is due to improved insulin sensitivity.   "
234974|NCT00928889|"     This study was conducted to demonstrate superiority of nateglinide in postprandial glucose     fluctuation, dyslipidemia, and inflammatory status improvement.   "
234975|NCT00928902|"     This clinical pilot study will test the hypothesis that systemic low-dose IL-2 therapy     significantly enhances the immunologic efficacy of a vaccine comprising melanoma peptides     plus GM-CSF-in-adjuvant.   "
235237|NCT00935909|"     The primary purpose of this prospective, randomized trial is successful intravenous (IV)     cannulation on first attempt with the use of either the Vein Viewer (VV) or standard     cannulation method. The secondary purpose is to find out if there is a difference in the     total time to successful cannulation.   "
239434|NCT00982462|"     The hypothesis to be examined is that dietary LCP-supplementation in the second and third     years of life will improve cognitive and visual maturation in early childhood.   "
234976|NCT00928915|"     Intracerebral haemorrhage (ICH) is the most feared complication in patients on vitamin K     antagonists (VKA). VKA related ICH occurs 8-10 times more frequently and the mortality is 2     times higher than in non-anticoagulated patients. Mortality may rise up to 67%. The higher     mortality rate may in part be due to the higher rate of haematoma expansion (HE) over a     longer period after symptom onset. International guidelines recommend treatment of VKA-ICH     with prothrombin complex (PCC) or fresh-frozen plasma (FFP) both in combination with     Vitamin-K. But these recommendations are not based on randomized controlled trials. It is     known that these drugs lower the INR, and thus it is assumed that normalization of     coagulopathy may lead to haemostasis and reduction of HE. Safety and efficacy of these     treatments have never been studied in a prospective controlled trial.      The investigators' questions are: How potent are PCC and FFP in normalization of the INR?     What is the safety profile of each of these drugs?   "
234977|NCT00928928|"     Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for     colorectal cancer   "
234978|NCT00928941|"     Post Traumatic Stress Disorder (PTSD) is an emotional disorder that can also lead to problems     with attention and memory. Cognitive training has been successfully used to improve attention     and processing speed in other patient populations as well as healthy elderly. The purpose of     this study is to examine how effective cognitive training will be in Veterans with PTSD.   "
234979|NCT00928954|"     Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients,     who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV.     Two medicines have been reported to suppress nystagmus and improve vision in such patients:     gabapentin and memantine. The investigators set out to test which of these two drug was more     effective by carrying out a double-blind cross-over study. In this way, we could determine     which drug worked best in each patient.   "
234980|NCT00928967|"     To evaluate the evolution of the impact on daily life activities over the first 12 months     following the introduction of interferon beta-1b treatment in patients presenting RRMS or     patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating     event   "
234981|NCT00928980|"     The purpose of this study is to investigate the (cost)effectiveness of mindfulness based     cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination     with regard to the prevention of relapse or recurrence in patients with recurrent depression.   "
234982|NCT00928993|"     The purpose of this study is to learn how well an instrument called an Actiwatch-2 can     determine whether a child is asleep or awake. The Actiwatch-2 (manufactured by     Minimitter/Respironics of Bend, Oregon) is the brand name for an actigraphy monitor; that is,     a motion sensor that is typically worn on the wrist and looks like a wrist watch. It measures     and records the amount of movement a person makes each minute. After being worn overnight,     data are transferred from the Actiwatch to a computer, and a program estimates whether a     person is awake or asleep by analyzing the recorded movement data. The enrollment target is     80 participants. Although other actigraphy equipment has been used to monitor sleep in     children, the Actiwatch-2 has not been validated in the pediatric population.   "
234983|NCT00929331|"     This study is designed to test the safety and immunogenicity of Fluviral® (2009 - 2010     Season) in adults aged 18 to 60 years and over 60 years.   "
234984|NCT00929344|"     A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150     outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d,     duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and     follow-up visits 1 week and 3 months post-treatment.   "
234985|NCT00929357|"     This study involves review and analysis of disease activity in patients with rheumatoid     arthritis who where treated with either conventional DMARDs (Disease Modifying Antirheumatic     Drugs) or Biologics and have two existing, consecutive radiographs (x-ray images) of hand and     feet taken as part of routine treatment monitoring within a time interval of 12 to 36 months.   "
234986|NCT00929370|"     The purpose of this study is to understand safety and tolerability of the drug GSK1018921     after 14 days of dosing in healthy volunteers and then in patient volunteers.   "
234987|NCT00929383|"     The IRISS study is designed to collect clinical and angiographic outcomes data when stenting     intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA     Balloon Catheter in routine clinical practice.   "
234988|NCT00929396|"     The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit     vaccine administered at 0 and 2 months.   "
234989|NCT00929409|"     200 patients with post partum anemia will be randomised to receive either intravenous iron     (intervention group) or peroral iron (control group).      The hypothesis is that intravenous iron supplementation is superior to standard peroral iron.   "
234990|NCT00929422|"     Background: Spinal cord injury (SCI) results in dysfunction of motor and sensory system and     the hormonal secretion. Not only the change of peripheral hormonal organs, the central     neurotransmitters were also affected. We consider there are some changes in cerebral     physiology, anatomy or function after SCI.      Objective: Use PET imaging to investigate the brain functional difference among the SCI and     control group.   "
234991|NCT00929435|"     One hundred new residents will be recruited prior to the start of residency and followed     prospectively for a year. Monthly nasal swabs will be performed to identify colonization with     methicillin resistant staphylococcus aureus (MRSA).The proportion of study subjects colonized     with MRSA at the end of 1 year will be calculated.   "
235019|NCT00929812|"     As a counterregulatory hormone for insulin, glucagon plays a critical role in maintaining     glucose homeostasis in vivo. It is well known that intramuscular glucagon administration     stimulates growth hormone (GH), adrenocorticotropic hormone (ACTH) and cortisol release in     humans. Recently, it has been shown that glucagon induces a remarkable decrease in ghrelin     levels. The mechanisms underlying this effect are unclear and the role of changes in glucose,     insulin, glucagon-like peptide-1 (GLP-1) and catecholamines are widely discussed. The aim of     the present study is to further evaluate the effect of glucagon on ghrelin secretion and the     possible role of the above mentioned factors in mediating this effect.   "
235700|NCT00933868|"     The purpose of this study is to evaluate the effect of six intravenous (IV) infusions of     magnesium chloride versus placebo in patients who have residual muscle weakness from a stroke     that occurred three months to four years ago.   "
234992|NCT00929448|"     The development of pneumonia and other infections is one of the most common complications of     a traumatic brain injury (TBI). Prior studies have also found that patients suffering from     TBI also develop immune dysfunction consistent with an immunosuppressed state shortly after     the traumatic event. Specifically, it has been shown that patients with a TBI have impaired     delayed type hypersensitivity (DTH), cellular immunity and humoral immunity. The humoral arm     of the immune system is particularly involved in defending the host against extracellular     bacteria and is primarily composed of B-cells, immunoglobulins and complement. Surgery and     trauma impair the clonal expansion of antibody producing B lymphocytes causing     hypogammaglobulinemia, through a mechanism involving T lymphocytes. In addition, during the     systemic inflammatory process, pro-inflammatory cytokines such as tumor necrosis factor alpha     (TNF-alpha), interleukin 1 (IL-1beta) and interleukin 6 (IL-6) are released. Nuclear factor     kappa beta (NF-kB) is a transcriptional regulatory protein that is involved in the expression     of proinflammatory cytokines and appears to act at a critical step in the transcription of     many proinflammatory genes.      The hypothesis of this study is that the hypogammaglobulinemia from the immune dysfunction     and the induction of NF-kB from the inflammatory process are, in part, responsible for the     development of pneumonia and other infectious complications identified after TBI. This study     has two specific aims: The primary specific aim of this study is to determine the association     between serum immunoglobulin or NF-kB levels and the development of pneumonia in patients     suffering from traumatic brain injury (TBI). The secondary specific aim of this study is to     determine the relative contribution of clinical variables such as APACHE II-III Score and     Injury Severity Score as compared to immunological variables (serum immunoglobulins and     NF-kB) to the development of pneumonia in patients suffering from TBI.   "
234993|NCT00929461|"     Pre- and intra-operative nutritional support in patient undergoing major surgery results in     decreased morbidity and mortality. Studies investigating the role of omega-3 fatty acids in     these patients are increasing. Some are focused on perfusion at the cellular level. This     study was undertaken to address the effect of postoperative administration of omega-3 fatty     acids on cellular hypoperfusion associated with major gastric surgery.   "
234994|NCT00929474|"     Cardiac resynchronization therapy (CRT) has shown improvement in mortality and morbidity in     patients with left ventricular systolic dysfunction and congestive heart failure.     Additionally in CRT patients it has been demonstrated that optimizing paced/sensed     atrioventricular (AV) and interventricular (V-V) timings leads to immediate hemodynamic     benefits and further improves cardiac function. Recent studies have shown that optimal     paced/sensed AV and V-V delays change over time, which raises the question of how often     optimization should be repeated. Thus, frequent re-optimization of these delays might be     beneficial for maintaining significant improvement of cardiac function. However, it remains     to be evaluated whether timing optimization may be beneficial on patients who have received     CRT for a number of years and are now having the CRT device replaced.   "
234995|NCT00929487|"     The purpose of this study was to clinically evaluate lens care solutions used with soft     contact lenses.   "
234996|NCT00929500|"     The purpose of this study is to test whether a supervised mixed aerobic and strength training     (MAST) program is effective in improving overall physical fitness and blood flow in the brain     and lowering risk factors of coronary artery disease (CAD) in women with metabolic syndrome.   "
234997|NCT00929526|"     This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against     cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological     abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic     HPV types for an additional two years. All subjects who participated in the primary     vaccination study NCT00316693 and who confirmed their interest in participating in a long     term follow up study will therefore be invited to be followed for up to 48 months after     administration of the first dose of vaccine. In addition, safety and persistence of the     humoral immune response will be evaluated in this study.      This protocol posting deals with objectives & outcome measures of the extension phase at     Months 36 and 48. The objectives & outcome measures of the primary phase are presented in a     separate protocol posting (NCT number = NCT00316693).   "
234998|NCT00929539|"     The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the     safety and tolerability of JTT-130 in obese Type 2 diabetic patients.   "
234999|NCT00929552|"     The aim of the study is to investigate if dietary fish oil has a beneficial effect on blood     pressure, insulin sensitivity, blood lipid profile, body composition and metabolic rate in     healthy, but slightly overweight, teenage boys.      We hypothesized that the n-3 long chain polyunsaturated fatty acids from fish oil might have     greater effect during growth and development, as intervention trials studying the effect of     fish oil on babies have shown greater effects than in adults.   "
235000|NCT00929565|"     Some of the risk factors for bleeding following bronchoscopy is having a malignancy or an     immunocompromised state. The etiology of this remains uncertain. The investigators suspect     that individuals with malignancy have abnormalities involving certain factors that influence     the coagulation pathway.      The investigators plan to measure these factors prior to and after bronchoscopy.   "
235001|NCT00929578|"     The objective of this study is to assess the safety and biologic activity of intralesional     injection of fluphenazine in adult subjects with psoriasis.   "
235002|NCT00929591|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Drugs     used in chemotherapy, such as doxorubicin, cyclophosphamide, and fluorouracil, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. It is not yet known whether giving tamoxifen alone is more effective in     treating breast cancer than giving tamoxifen together with chemotherapy or after     chemotherapy.      PURPOSE: This randomized phase III trial is studying giving tamoxifen with or without     combination chemotherapy to compare how well they work in treating postmenopausal women who     have undergone surgery for breast cancer.   "
235003|NCT00929604|"     No randomized clinical trial to date has demonstrated a survival benefit of using regular     HIV-1 ribonucleic acid (RNA) viral load (VL) testing to monitor patients' responses to     antiretroviral therapy (ART) for HIV infection. The measurement of VL is recommended to     monitor the response to ART in developed countries. In resource-constrained settings, the     World Health Organization (WHO) does not recommend routine VL testing, in part due to the     cost and complex infrastructure needed for reliable results. In these settings, WHO has     proposed the use of clinical and CD4+ lymphocyte-based criteria to guide treatment decisions.     However, multiple studies have demonstrated the poor performance of these criteria in     sub-Saharan Africa and the frequent discordance between immunologic and virologic responses     to ART.      The use of routine viral load monitoring should be evaluated in resource-constrained     settings. The investigators hypothesize that routine viral load testing of patients on ART     will improve patient survival, decrease disease progression and development of drug     resistance, and will be feasible and cost-effective for resource-constrained settings.   "
235005|NCT00929630|"     Surgical treatment of perianal fistulas frequently affects fecal continence. Sphincter saving     techniques like loose or cutting seton and fistulectomy with advancement of an endorectal     flap have been advocated to minimize the risk of sphincter injury, but patients often     complain of a prolonged healing period and major discomfort. Furthermore, the healing rate     varies widely according to the type of fistula and the surgeon's experience.In the early '90s     the treatment of perianal fistulas by autologous or commercial fibrin glue was suggested and     the American FDA approved the use and marketing of a human fibrin glue in 1998.      Since then, several studies have evaluated the effectiveness of human fibrin glue in the     treatment of different types of perianal fistulas, reporting a wide range of success rates     ranging from 31 to 85%.      Primary aim of this study is to conduct a prospective randomized trial evaluating the     effectiveness of glue treatment of perianal fistulas as compared with the classical seton     treatment. Secondary aims are to compare postoperative faecal incontinence, postoperative     anal pain, healing time and length of hospitalization.   "
235006|NCT00929643|"     The objective of this study is to estimate the costs of empiric antibiotic therapy and     hospitalization costs for patients with a complicated intra-abdominal infection, and to     assess the impact of treatment failure of initial antibiotic empiric therapy on     pharmacological and total healthcare costs for these patients in Greece.   "
235007|NCT00929656|"     Stroke is the leading cause of long-term disability in this country with more than 1 million     Americans reporting difficulty with daily activities. Loss of independence in self-care tasks     is primarily due to limited recovery of the arm. This study will determine if the addition of     Transcranial Magnetic Stimulation (TMS) to excite the lesioned hemisphere (side of the brain     affected by the stroke), to progressive functional task exercise either of the weakened arm     alone or of both arms together will improve arm recovery to a greater degree than one of     these two types of arm exercise alone. Individuals post-stroke will participate in 16     sessions of 1) arm rehabilitation alone (with the weaker arm only or with both arms together)     or 2) arm rehabilitation plus TMS. The investigators will assess arm movement ability and     function immediately following the 4-week intervention and at a 30-day follow-up to determine     retention of immediate gains. The investigators hypothesize that those who receive TMS as an     adjuvant will have improved arm movement ability than those who only exercise.   "
235008|NCT00929669|"     The purpose of this study is to determine if administration of pasireotide LAR for one year     to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce     the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.   "
235009|NCT00929682|"     In a prospective randomised study involving primiparous women in spontaneous uncomplicated     labour with cervical dilatation > 7 cm, epidural analgesia will be given with an initial     volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual     injections to achieve analgesia, then by a patient-controlled regimen with 5-mL     self-administered boli in addition to a continuous infusion of 5 mL.hr-1. The anaesthetic     solution will be levobupivacaine presented in 100-mL bags from the market, 0.0625%, or     0.125%, in which 10 mL (50 µg) of sufentanil will be added. The final concentrations will be     0.568 and 1.136 mg.mL-1 respectively, both with sufentanil 0.45 µg.mL-1. Parturients and     midwifes assessing pain during labour will be blinded to the design   "
235010|NCT00929695|"     This randomized phase III trial is studying low-dose prednisone or methylprednisolone to see     how well they work compared with standard-dose prednisone or methylprednisolone in treating     patients with newly diagnosed acute graft-versus-host disease (GVHD). Glucocorticoids, such     as prednisone or methylprednisolone at a starting dose of 2 mg/kg/day are standard treatment     for acute graft-versus-host disease caused by a donor stem cell transplant. It is not yet     known whether low-dose glucocorticoids are more effective than standard-dose glucocorticoids     in treating acute graft-versus-host-disease   "
235014|NCT00929747|"     A prospective evaluation of postoperative corneal aberrations and visual parameters in     patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group     implanted with a SN60WF IOL and having concomitant limbal relaxing incision.   "
235015|NCT00929760|"     This is a prospective randomised trial studying patients with stage 3 to 5 chronic kidney     disease (CKD) in order to determine the impact of specialised care by nephrologists compared     to guidelines-directed management by primary care physicians (PCP) on: a) prognosis (clinical     outcome), b) planning of renal replacement therapy (RRT) (urgent versus planned initiation     RRT) and c) patient satisfaction.   "
235016|NCT00929773|"     The purpose of this study was to determine whether low level laser light directed at the neck     and shoulders could be effective in the temporary reduction of chronic pain in the neck and     shoulder region.   "
235017|NCT00929786|"     The purpose of this study is to evaluate plasma levels of hepatotoxic anti-tuberculous drugs     (isoniazid, rifampicin, pyrazinamide plus significant metabolites) among patients on     antituberculosis treatment (ATT) and compare the same among those who develop drug induced     hepatitis on follow up versus those who do not.   "
235018|NCT00929799|"     The aim of the study is to investigate changes in insulin sensitivity and ß-cell function     after 24 and 48 weeks of low-dose growth hormone (GH) therapy in adult patients with severe     GH deficiency using highly standardized techniques. Insulin sensitivity was estimated using     euglycemic, hyperinsulinemic clamps, while insulin secretion and hepatic insulin clearance     were determined by changes in insulin and C-peptide levels during hyperglycemic     hyperinsulinemic clamps with consecutive intravenous (i.v.) L-arginine stimulation tests.     Moreover, the researchers investigated changes in body composition, lipolysis and     cardiovascular risk markers. Furthermore, in order to verify the mechanisms involved in the     pathogenesis of GH-induced insulin resistance and the GH-induced improvement in insulin     resistance under long term treatment, the researchers intend to establish changes in     intramyocellular lipid (IMCL) in patients with GH deficiency by magnetic resonance     (MR)-spectroscopy before and during GH-treatment and to correlate IMCL with insulin     resistance, insulin secretion and insulin clearance. Finally, the researchers aim to justify     the effect of GH on adiponectin secretion as well as on the 11-ß hydroxylase activity.   "
235118|NCT00931125|"     This study investigates the hypothesis that ranibizumab injection given into the eye is a     safe, efficacious and helping treatment option applied before surgical intervention of the     proliferative diabetic retinal eye disorder.   "
235020|NCT00929825|"     The transplantation of hematopoietic stem cells (THSC) is a therapeutic modality developed     for the treatment of various diseases such as leukemia, bone marrow aplasia, lymphomas,     multiple myeloma, among others. Most patients who undergo the THSC usually have oral     manifestations as a result of immunosuppression achieved by chemotherapy and/or radiotherapy.     The most common complications are the reduction of salivary flow, mucositis and     graft-versus-host disease (GVHD). These conditions can be very debilitating and interfere     with medical therapy, leading to systemic complications, affecting the prognosis and     increasing the length of hospitalization of the patient and the costs of treatment. To date,     there is no protocol that prevents the reduction of salivary flow and minimizes the     occurrence of mucositis and GVHD in these patients. This study aims to verify the     effectiveness of treatment with two sialogogues (Hyperboloid and TENS [transcutaneous     electrical stimulation]) to restore the flow and biochemical composition of saliva in     patients undergoing THSC myeloablative and non-myeloablative conditionating regime.   "
235021|NCT00929838|"     Blacks or African Americans have greater risk of and are more likely to die from type 2     diabetes (T2DM). Major barriers to effective diabetes care for Blacks include poor diabetes     knowledge, self-management skills, empowerment, and perceived control. Few prior studies have     tested interventions to address these barriers in combination, especially among Blacks who     have the greatest burden of diabetes related complications. This study provides a unique     opportunity to address this gap in the literature by testing the efficacy of separate and     combined telephone-delivered, diabetes knowledge and motivation/behavioral skills training     intervention in high risk Blacks with poorly controlled T2DM. The findings of this study, if     successful, will provide new information on how to improve quality of care for diabetes in     ethnic minorities and reduce the disproportionate burden of diabetes complications and deaths     in this population.   "
235022|NCT00929851|"     a 48-week, 2-arm parallel group, fixed combination beclomethasone dipropionate plus     formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary     disease   "
235023|NCT00929864|"     The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no     worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis     who are biologic naive   "
235024|NCT00929877|"     Primary Objective:      To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg     ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15-120)     after the first intake of study drug.      Secondary Objectives:      To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) with     placebo after the first intake on:        -  the total pain relief summed over 15 to 360min (TOTPAR15-360)        -  the changes from baseline of global throat pain intensity assessed over 15 to 120min and          over 15 to 360min.        -  the changes from baseline of throat soreness over 15 to 120min and over 15 to 360min        -  the changes from baseline of swollen throat over 15 to 120min and over 15 to 360min To          compare pain relief, global throat pain intensity, throat soreness and swollen throat in          the evening of days 1, 2 and 3      To evaluate the safety of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) and placebo at     follow-up visit on:      Day 4: - adverse events and clinical examination Day 7: - adverse events reporting (followed     by a clinical examination if needed)   "
235052|NCT00930241|"     This study is a prospective randomized trial to compare twice daily to once daily     administration of the basic immunosuppressive regimen in lung transplanted patients.   "
235025|NCT00929890|"     This study tests the hypothesis that exercise training can confer additional benefit to     patients in weight-loss programs in the form of improvements in either metabolic or vascular     parameters or both. Patients will be randomized to either diet plus conventional physical     activity or diet plus a planned exercise training. The interventions will be carried out     until the patients lose between 5% and 7.5% of their initial weight. At entry and at the end,     all subjects will be evaluated for outcomes such as blood glucose, lipid profile, insulin,     c-reactive protein, fibrinogen, vascular reactivity (doppler ultrasound) and total and     abdominal visceral fat (CT-scan). Both groups will be compared.   "
235026|NCT00929903|"     This phase I trial is studying the side effects and best dose of pazopanib hydrochloride in     treating young patients with solid tumors that have relapsed or not responded to treatment.     Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.   "
235027|NCT00929916|"     This study will evaluate whether morning-only dosing of MoviPrep® (2L) for afternoon     colonoscopy is as effective as a standard dosing regimen of half of the volume of MoviPrep®     (1L) solution the evening prior, and half (1L) the morning of, colonoscopy. MoviPrep® is a     low volume (2 liters) polyethylene glycol (PEG)-based purgative that is approved for     evening-only or split (evening and morning) dosing to cleanse the colon prior to colonoscopy.     Patients undergoing afternoon colonoscopies often have inferior colon cleansing. There is     evidence that morning-only purgative administration of large volume PEG (4L) is safe and     effective. This study will assess whether administration of a low volume PEG regimen will     maintain efficacy and improve tolerance by changing a 2-day preparation procedure into a     regimen that is completed in 1 day.   "
235028|NCT00929929|"     The purpose of this study is to determine whether a nutritional supplement with an amino acid     called leucine along with resistance exercise are effective in the improvement of muscle     strength and quality of life in elderly people.   "
235029|NCT00929942|"     A prospective observational trial involving 10 patients is planned. Intervention SX-ELLA     Stent Degradable DV Bronchial (DV Stent) will be implanted in the target lesion in general     anesthesia under fluoroscopy or by direct vision. Before dilatation, extension of the airway     complications will be measured by bronchoscopy and documented.   "
235119|NCT00931138|"     Randomized comparison of standard induction treatment with daunorubicin for 3 days and     Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of     maintenance treatment with IL2   "
235120|NCT00931151|"     Dietary protein differing by their amino acid composition could modulate undesirable     metabolic and functional responses to a meal rich in saturated fat and sugars. This study     aims at examining the specific effects of dairy protein with different cysteine contents on     the postprandial undesirables effects elicited by the ingestion of a high fat meal in     overweight subjects.   "
235030|NCT00929955|"     There is some evidence that anti-inflammatory treatment may have beneficial effects in     schizophrenia and major depression. Cox-2 inhibitors have been tested in preliminary clinical     trials for schizophrenia and depression, showing favourable effects compared to placebo     (Muller and Schwarz et al 2009).      Statins were introduced as cholesterol-lowering agents but have found much wider usage. They     are anti-inflammatory agents and thus similar to the Cox-2 inhibitors, which have shown some     ability as adjuncts to improve the symptoms of schizophrenia in preliminary studies. The     statins are also known to decrease C-reactive protein (CRP), which has been shown in an     SMRI-funded study to be elevated in a study of individuals with schizophrenia. Fan et al     (2007) demonstrated in a small study in patients with schizophrenia that higher than normal     levels of CRP (>0.50 mg/dl) was associated with marked negative symptoms and higher total     PANSS scores.      Ondansetron is a serotonin (5-HT3) receptor antagonist that is generic and widely used to     prevent nausea and vomiting in patients receiving chemotherapy for cancer. GSK did a small     study on it as an antipsychotic in the 1980s. Since then, several small studies have     suggested that it is effective as an adjunct drug in improving the symptoms of schizophrenia.      Statins are widely used in schizophrenia sufferers, particularly those taking second     generation antipsychotics, to treat hypercholesterolemia. Both drugs are well tolerated and     their side effect profiles well understood.      We propose to conduct a feasibility study in patients with chronic schizophrenia to explore     the adjunct use of simvastatin and ondansetron on positive, negative and general     psychopathology in comparisons to treatment as usual (TAU) over a 12 week period.   "
235031|NCT00929968|"     This study will assess the safety and tolerability of multiple doses of VAK694 as well as     change in symptoms and biomarkers in patients with seasonal allergic rhinitis   "
235032|NCT00929981|"     This study will be a prospective, non-interventional, single arm and open label study, in     patients with contact dermatitis requiring systemic steroid therapy with a purpose to obtain     the real life effectiveness and tolerability of Medrol in treating contact dermatitis in     Indian patients. Patients with contact dermatitis who have been prescribed for Medrol will be     enrolled into the study and will be followed up for the resolution of symptoms   "
235033|NCT00929994|"     It is hypothesized that the addition of formal cardiac rehabilitation to standard care will     result in long-term improvements in cardiovascular fitness and functional capacity in     individuals who have suffered a transient ischemic attack (TIA) or minor stroke.      Furthermore, it is proposed that the addition of cardiac rehabilitation will influence stroke     risk, physical activity participation, strength, and quality of life.   "
235034|NCT00930007|"     The purpose of this study is to determine whether sleep-wake changes of luteinizing hormone     pulse frequency are different in early pubertal girls with high testosterone levels compared     to early pubertal girls with normal testosterone levels.   "
235035|NCT00930020|"     Background: Stroke is a leading cause of death and chronic serious disability worldwide.      Minocycline, a semisynthetic tetracycline, has consistently been shown in recent years to be     neuroprotective in animal models of brain ischemia. Furthermore, a small, open label study     done in humans with acute ischemic stroke published late last year showed that minocycline,     when administered for 5 days, within 6 to 24 hours after stroke onset was highly effective in     improving functional outcome even as early as 7 days after stroke onset. However, further     well-conducted, randomized controlled translational studies using minocycline are currently     lacking.      Objective: To determine if minocycline, administered within 3 to 48 hours after acute     ischemic stroke onset is superior to placebo in reducing neurological deficit and improving     functional outcome at 90 days post stroke.      Methods: The investigators plan to do a multi-centre randomized, double-blind, placebo     controlled trial in which ischemic stroke patients will be randomized to treatment with     either oral minocycline or placebo within 3 to 48 hours of symptom onset. The primary     efficacy endpoint will be the modified Rankin scale (mRS) score for all randomized subjects     at 90 days.      Secondary endpoints will include improvement of the NIH Stroke Scale (NIHSS) score from     baseline and Barthel index at 90 days.      NeuMAST will test the following hypotheses:      Primary Hypothesis: Minocycline, compared with placebo, when administered between 3 to 48     hours after the onset of acute ischemic stroke improves recovery and functional outcome as     assessed by mRS scores on day 90 post-stroke.      Secondary Hypotheses:        1. Minocycline compared to placebo, when administered between 3 to 48 hours after onset of          acute ischemic stroke improves recovery and functional outcome as assessed by          improvement of NIHSS score on day 90 post-stroke.        2. Minocycline compared to placebo, when administered between 3 to 48 hours after onset of          acute ischemic stroke improves functional outcome as assessed by the Barthel Index (BI)          score on day 90 post-stroke.        3. Minocycline, compared with placebo reduces 90 day risk of recurrent stroke, MI or death          when administered between 3 to 48 hours after acute ischemic stroke onset.      A positive result will have a significant impact in the management of acute ischemic stroke     and pave the way for future studies aimed at finding the optimal dose and formulation of     minocycline for treating acute ischemic stroke.   "
235037|NCT00930046|"     The investigators propose a prospective blinded randomized control trial (RCT) to assess the     efficacy and safety of a simple method of continuous infusion of a local anesthetic,     ropivacaine, via a surgical wound to control pain after ureteropelvic junction (UPJ) stenosis     correction in children during the first 48 hrs after surgery. The investigators hypothesize     that this technique will provide greater pain relief post-operatively and reduce the need for     systemic opioid use along with a reduction in associated side effects of such analgesics.   "
235038|NCT00930059|"     The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on     cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and     tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in     the plasma over the course of the study.   "
235039|NCT00930072|"     To evaluate the feasibility of performing a cervical sympathetic block in patients with     severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal     SAH.   "
235040|NCT00930085|"     The mortality induced by infections in onco-hematological patients is abnormally high at the     acute phase of septic shock. Consequently, it is important to detect the population with a     high risk of short term mortality among patients with a septic shock. The aim of this study     is the evaluation of predictive proteic profile on the short term mortality in the acute     phase of septic shock in cancer patients.   "
235041|NCT00930098|"     This study is for a population of patients with few or no alternative options that was     conducted to determine the response rate to clofarabine. Additionally the study will provide     information on the safety profile, impact of overall survival, and impact on remission     duration with clofarabine. It is a single arm study and has no comparator.   "
235042|NCT00930111|"     The investigators are testing the effects of a change in teaching attending physicians'     rotations (from 4- to 2-week blocks) on patient outcomes (unplanned urgent visits to the     health care system, inpatient mortality, and length-of-stay), the educational experiences of     residents and medical students and on the quality of the professional lives of the attending     physicians.   "
235444|NCT00938314|"     The purpose of this study is:        -  To assess the neurological outcome in acute ischemic stroke patients treated with          NTx®-265, when compared with patients given a placebo control.        -  To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke          patients.   "
235043|NCT00930124|"     Cleft lip and palate patients normally present with a sunken face due to collapse in the     middle part of the face and inability of the upper and lower teeth to meet during chewing.     This situation constitutes a serious aesthetic and mastication problem. A single surgical     operation known as orthognathic surgery was traditionally performed to move the upper jaw     forward to a more normal position and allow chewing function to be regained. However, due to     scar tissue from the original surgical repair of the cleft palate, this procedure is known to     be unstable causing bone to rapidly go back to its original position. A new concept of moving     the upper jaw bone gradually by 1mm per day using a special device attached to the bone     called distraction osteogenesis was established in 1996. Animal studies have shown that this     technique can produce stable results with minimal relapse. The feasibility of correcting     cleft deformities by gradual distraction has been confirmed by our own clinical studies. The     aim of this study (which is the first of its kind) is to conduct a prospective randomized     controlled study and compare the treatment outcomes of the current standard (orthognathic     surgery) with distraction osteogenesis (gradual bone movement). The objectives focus on four     aspects: morbidity, stability, speech function and psychological impact. The results from     this study will clarify several clinical dilemmas in decision making when choosing whether to     use orthognathic surgery or distraction osteogenesis in the treatment of cleft lip and palate     patients. In addition, it will also inform our multidisciplinary research team to improve the     total care of the cleft lip and palate patients.      Gradual bone distraction of the midface in cleft palate patients is more stable, less     detrimental to speech, and no more troublesome to the patient than conventional osteotomy and     bone transposition (orthognathic surgery).   "
235044|NCT00930137|"     While the deleterious effects of trans fat from industrial sources (iTFA) on cardiovascular     health are well established, the impact of TFA from ruminants (rTFA) on cardiovascular risk     factors has not been as well characterized. We have previously shown in men that a very high     dietary intakes of rTFA (>3.5% of energy) leads to unfavourable changes in lipid     cardiovascular risk factors that are similar to those seen with iTFA. However, our data also     indicated that achievable intakes of rTFA that remain well above the current human     consumption (1.5% of energy intake) had neutral effects on plasma lipids and other     cardiovascular disease (CVD) risk factors in men. Other studies have also suggested that the     LDL and HDL response to very high dietary intakes of rTFA (>5% of energy) in women may be     different than in men.      The general objective of the study is to investigate for the first time in a double-blind     randomized controlled study the impact of high but yet achievable intake of ruminant trans     fatty acids on plasma LDL-Cholesterol and other risk factors for CVD in healthy women.   "
235045|NCT00930150|"     This study will test whether a cognitive remediation program to treat people with     schizophrenia can be successfully implemented in a network of research clinics.   "
235046|NCT00930163|"     This is a randomized, double-blind, placebo-controlled study to evaluate the effects of     lebrikizumab in patients with asthma who remain inadequately controlled while on chronic     therapy with inhaled corticosteroids (ICS).   "
235047|NCT00930176|"     The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single     dose of 25IU/kg.      The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the     treatment of bleeding episodes over at least 6 months.   "
235048|NCT00930189|"     The purpose of this study is to compare the efficacy of photodynamic therapy with verteporfin     (PDT) and IVTA vs triple therapy (TT) in patients with subfoveal choroidal neovascularization     (CNV) secondary to age-related macular degeneration (AMD).      The investigators designed a prospective, comparative, randomized, double blind, controlled     study. 15 patients with classic subfoveal choroidal neovascularization secondary to     age-related macular degeneration were randomized. Triple therapy can potentially offer a new     treatment modality for choroidal neovascularization in patients with macular degeneration and     other diseases.   "
235049|NCT00930202|"     The investigators plan to utilize conivaptan (Vaprisol) to promote isolated water loss, in     combination with normal (physiologic) fluid replacement to maintain a normal blood volume     status, in patients with severe TBI. The goal of this therapy is to raise blood sodium in a     controlled fashion in subjects with severe TBI, and reduce the use of hypertonic saline     infusion. We hypothesize that this therapy will maintain a stable state of high blood sodium,     while decreasing the overall sodium load needed to achieve these goals.   "
235050|NCT00930215|"     The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is     bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5   "
235051|NCT00930228|"     The purpose of this study is to determine whether a testosterone receptor blocker (flutamide)     will normalize sleep-wake luteinizing hormone pulse frequency relationships in women with     polycystic ovary syndrome.   "
235053|NCT00930254|"     This research, aimed to verify whether the use of vascular ultrasonography (VUS) could lead     to better results in the peripheral venous access implementation in children.      Objectives: To compare, regardless of the number of venous puncture attempts, peripheral     venous access obtained in children, according to VUS use or traditional method for peripheral     intravenous catheter (PIC) insertion; assertiveness in the use of PIC in children, defined as     success in the first attempt of puncture and PIC withdrawal according to release of     treatment, related to VUS or traditional method and to describe the influence of VUS on PIC     dwell time and development of local complications related to the use of intravenous therapy     in children.   "
235054|NCT00930267|"     A prospective epidemiological study conducted in pediatric hematology oncology center in     Hadassah medical center. The study will include all newly diagnosed pediatric cancer patients     age 0-18 years admitted with fever during chemotherapy.      In each event of febrile episode during chemotherapy, the following data will be collected     using a patient data form and computerized software.      Demographic data: age, gender, ethnicity. Clinical data: Underlying disease, immunizations,     prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy,     duration of fever, duration and severity of neutropenia, diagnosis of present event.      Imaging data Microbiological data Outcome The statistical analysis will be performed by an     epidemiologist and statistician using the SPSS 12.0 software.   "
235055|NCT00930280|"     The purpose of this study is to find risk factors for hemorrhagic stroke, specifically     intracerebral hemorrhage (ICH).   "
235056|NCT00930293|"     This study will examine the feasibility and efficacy of a personalized psychotherapy     treatment for people with depression and co-occurring anxiety.   "
235057|NCT00930306|"     The aims of this study are to examine the effect of repeated doses of AZD2066 and of     caffeine, bupropion, tolbutamide, omeprazole, metoprolol and midazolam on the blood     concentrations of each other   "
235445|NCT00938327|"     This post marketing surveillance will evaluate reactogenicity and safety data of human     rotavirus vaccine when administered to healthy infants according to the Prescribing     Information in India.   "
235058|NCT00930319|"     Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced     Hormone-dependent Prostate Carcinoma. The period until Prostate Specific Antigen (PSA)     progression during the Firmagon® therapy is to be documented and related to the testosterone     values measured in the course of therapy (if available). Other clinical parameters, the     patients' quality of life and the direct and indirect costs incurred by the medical care for     the advanced hormone-dependent prostate carcinoma and its consequences will be evaluated. In     this context the medical outcome and the life quality are defined as effectiveness and     benefit value parameters. Both the effectiveness under daily life circumstances and economic     variables of the therapy can thus be shown and compared within an analysis of costs vs.     benefits or costs vs. effectiveness.   "
235059|NCT00930332|"     RATIONALE: Methadone hydrochloride may reduce chronic neuropathic pain in patients with     cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of methadone     hydrochloride as first-line therapy in treating patients with chronic neuropathic cancer     pain.   "
235060|NCT00930345|"     The aim of this study is to identify and/or validate biomarkers and imaging markers to     predict and monitor the activity of a new class of therapeutic agents called antiangiogenics     for the treatment of metastatic renal cell carcinoma (mRCC). Suntinib, approved for this     indication, will be administred before and after nephrectomy and biomarkers sampling and     imaging will be operated to monitor the activity and identify prognostic factors in mRCC.   "
235061|NCT00930358|"     The aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation     or general anesthesia for colonoscopy   "
235062|NCT00930371|"     This study is designed to determine if the amount of fat and saturated fat in the diet     contributes to the development of a condition called fatty liver disease in the absence of     changes in weight.   "
235063|NCT00930384|"     Main objectives      1. Establish the association of psoriasis and the presence of NAFLD in the patients with     psoriasis attending dermatologic clinic center.      Secondary objective        1. Evaluate for the presence of other components metabolic syndrome in this group of          patients including hypercholesterolemia, hypertension, obesity, and insulin resistance        2. Determine if there is an association between the extent and severity of psoriasis and          the presence of NAFLD.        3. Identify an association between BMI and presence of NAFLD in people with psoriasis and          use it as a predictive index for primary screening of NAFLD in psoriatic patients.   "
235064|NCT00930397|"     Pre-eclampsia and intra uterine growth restriction (IUGR) represent major complications for     pregnant women, with a high related maternal and fetal morbidity and mortality. It is now     widely admitted that these pathologies, which can concern up to 7% of pregnancies, are in     relation with hypo-perfusion of the placenta because of an early deficient trophoblast     invasion and uterine vascular remodelling.Advances in ultrasound imaging now permit non     invasive 3D volume and Doppler signal quantification using automatic     acquisitions.Quantitative comparison of volumes and Doppler parameters between control     pregnancies and IUGR ought to confirm the theory of UTERO-placental hypo-perfusion. This     technique might allow an earlier prediction for IUGR. The aim of this study is to evaluate     the interest of 3D Doppler quantification as a new screening tool for pre eclampsia and IUGR.   "
235065|NCT00930410|"     The endomicroscopy is an adaptation of traditional optical microscopy in the digestive     endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a     videoendoscope, it's possible to study the digestive mucous by optical biopsy. This     monocentric, non randomized and prospective study uses the Intra-ductal confocal     endomicroscopy for the characterization of pancreas and bile duct tumor.   "
235066|NCT00930423|"     Atypical hemolytic uraemic syndrome is caused by defects in the regulating factors in the     alternative pathway of the complement system. Triggering can cause an uncontrolled complement     activation with endothelial damage and thrombotic micro-angiopathy, especially in the     kidneys. This can result in endstage renal failure. Complement activation during hemodialysis     has been described as a result of contact between blood and the dialysis membrane. Our     hypothesis is that patients with atypical hemolytic uraemic syndrome have a stronger     complement activation during hemodialysis than patients with another underlying kidney     disease. This could be a reason to treat patients with endstage renal failure due to atypical     hemolytic uraemic syndrome preferentially with peritoneal dialysis instead of hemodialysis.   "
235067|NCT00930436|"     Patients with Stage 3B, 4,or 5 Chronic Kidney Disease who are to undergo an angiography     procedure with contrast agent will be asked if they are willing to join the trial. If so they     will be screened and randomized to receive either sodium bicarbonate or saline before, during     and after the contrast media is given. They will be asked for serum samples 1 to 3 days, 7,     30, 90 and 180 days after the procedure to evaluate whether the sodium bicarbonate has     reduced the incidence of contrast induced chronic kidney disease by measuring their serum     creatinine, as well as whether they have required renal dialysis or other renal replacement     therapy.   "
235068|NCT00930449|"     Our primary aim is to determine whether a computerized working memory (WM) training program     will help students with severe learning and attention problems, in terms of improving their     WM. Additional aims are to determine whether the WM training will also result in improvements     in the students' concentration and school work, and how long any beneficial effects will last     (i.e., whether the students will continue to show improvements once the training program has     stopped).   "
235069|NCT00930462|"     The aim of this study is to compare the colonoscopy success rate, cecal time and polyp     detection rate between cap-fitted colonoscopy and conventional colonoscopy.   "
235070|NCT00930475|"     This is an open-label, mono-center phase I/II study designed to determine the maximum     tolerated dose (MTD) and dose-limiting toxicities (DLT) of RAD001 in combination with     carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic     breast cancer. Additionally, the study is designed to characterize the safety, the     tolerability and efficacy of this study.   "
235071|NCT00930488|"     For each patient, an initial visit and at least one follow-up visit at the end of treatment     should be documented by the treating physician in the case report form.   "
235072|NCT00930501|"     young female cancer patients have improving chances of survival. the main risk is a chronic     damage to their ovarian reserve. This may lead to future infertility.   "
235073|NCT00930514|"     This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and     intravenous rituximab in participants with follicular lymphoma. In the first stage,     participants who have achieved at least a partial response after induction treatment with     intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab     375 milligram per square meter (mg/m^2) intravenously, 375 mg/m^2 subcutaneously or 625     mg/m^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of     the subcutaneous dose (800 mg/m^2) which results in rituximab trough plasma concentration (C     trough) values comparable to those achieved with the intravenous formulation, participants in     the second stage of the study will be randomized to receive either the subcutaneous or     intravenous formulation to demonstrate comparability of the C trough levels with both routes     of administration. Maintenance therapy will continue every 2 or 3 months with the     subcutaneous formulation.   "
235074|NCT00930527|"     There are no data regarding the use of supplements to alleviate the musculoskeletal pain and     stiffness inducted by the use of aromatase inhibitors. This study is designated to test the     safety and efficacy of omega 3 fatty acid supplementation to alleviate musculoskeletal pain     in postmenopausal breast cancer patients.   "
235075|NCT00930553|"     This open-label, rater-blinded extension study enrolled participants who had     relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior     Genzyme-sponsored studies of alemtuzumab (CAMMS223 [NCT00050778], CAMMS323 [NCT00530348] also     known as CARE-MS I, or CAMMS324 [NCT00548405] also known as CARE-MS II). The purposes of this     study were:        1. To examine the long term safety and efficacy of alemtuzumab treatment in participants          who received alemtuzumab as their study treatment in one of the prior studies.        2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for          participants who received Rebif® (interferon beta-1a) as their study treatment in one of          the prior studies.        3. To determine the safety and efficacy of additional as needed alemtuzumab treatment          courses. This applied both to participants who received alemtuzumab for the first time          in one of the prior studies or for the first time in this extension study.   "
235076|NCT00930566|"     ECP will be given to the patients [UVAR®XTS TM Therakos system, Johnson & Johnson] according     to the following schedule:      Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the     first 2 weeks, and 1 ECP per week during 1 month.      Total = 8 ECP after transplantation.   "
235077|NCT00930579|"     The purpose of this pilot study is to use a pre surgical intervention model to evaluate the     biologic effects of metformin in women with newly diagnosed early invasive breast cancer.     Metformin is a drug commonly used to treat patients with diabetes. This model will be used to     evaluate the effects of metformin.   "
235078|NCT00930592|"     The objective of this study is to assess whether there is an increased risk of the metabolic     syndrome in children with psoriasis compared to children without psoriasis.   "
235079|NCT00930605|"     1. Primary Research Question What are the rates of complete response (CR), partial response          (PR), progression free survival (PFS) and overall survival (OS) in adult patients newly          diagnosed with Peripheral T-Cell Lymphoma (PTCL) who are treated with alemtuzumab given          in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone)          and ESHAP (etoposide, methylprednisolone, cisplatin, cytosine arabinoside) administered          as an up-front treatment?        2. Secondary Research Question What is the incidence of life-threatening toxicities (grade          3 and 4, according to WHO criteria, Appendix A) in the patients?   "
235080|NCT00930618|"     The purpose of this trial is to determine whether cervical ripening with isosorbide     mononitrate reduce caesarean section in women with post term pregnancies.   "
235081|NCT00930631|"     The purpose of this clinical study is to assess the safety, extent and route of [3H]     BMS747158 radioactivity eliminated (mass balance) in urine and feces of healthy male     subjects. The safety of [3H] BMS747158 administration will also be assessed, as well as     pharmacokinetics of [3H] BMS747158 and metabolite identification.   "
235082|NCT00930644|"     This study is a 2-year open label extension study to collect long term efficacy and safety     data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.   "
235095|NCT00930813|"     The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for     treatment of stenosis of the femoropopliteal arteries by direct comparison to standard     balloon angioplasty.   "
235083|NCT00930657|"     Objective:      To examine respiratory/physiological and subjective responding as well as genetic     transmission among offspring of parents with a history of or current panic disorder (PD)     diagnosis to determine whether diagnoses/symptoms, endophenotypes, or genetic profiles in     offspring is differentially related to parent PD subtypes (i.e., respiratory and     non-respiratory panic).      Study population:      Approximately 400 offspring of about 200 parents with current or past PD. Approximately 200     offsping/100 parents with PD will be enrolled at NIH/NIMH and the remainder at Virginia     Commonwealth University in Richmond, VA.      Design:      A high-risk family design will be used wherein parents with either a current or past     diagnosis of PD who have an offspring(s) (ages 9 to 20) will be recruited.      <TAB>      Outcome measures:      Outcome measures will include physiological recordings of respiratory, cardiac, and     electrodermal responding during a 10 minute baseline followed by 15 minutes of 5% carbon     dioxide enriched air (CO2). Research participants also will complete parent and child     self-report measures and provide a DNA sample using a saliva protocol. A full listing of     self-reports is provided in the Outcome Measures Section.   "
235084|NCT00930670|"     There is conflicting evidence in the literature suggesting that the use of proton pump     inhibitors (PPIs), and/or some statins can interfere with clopidogrel antiplatelet effect and     result in adverse cardiovascular outcomes in patients treated with coronary artery stents and     dual antiplatelet therapy.      The primary aim of the study is to determine the effect of various currently used PPI on     platelet aggregation in patients undergoing percutaneous coronary intervention (PCI) and     treated with dual antiplatelet therapy.      The secondary aim of the study is to evaluate how statins and 2C19*2 polymorphism modulate     the effect of PPI on clopidogrel efficacy.   "
235085|NCT00930683|"     To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with     scleroderma.   "
235086|NCT00930696|"     Surgical treatment of deep endometriosis with bowel involvement is widely accepted to require     complete excision of all endometriosis also when invading the bowel. In case of opening of     the bowel a subsequent inflammatory reaction follows the surgery, as demonstrated by the     increase in blood levels of C-reactive protein during the first post-operative week.     Furthermore it increases the risk of post-operative bowel complications. In case of     peritonitis the general surgeons use extensive lavage in order to decreases mortality,     morbidity and post-operative adhesions formation, as demonstrated in animal models and     clinically in patients with peritonitis. Considering the efficacy of extensive lavage for     peritonitis and the inflammatory reaction as judged by the increased C-reactive protein (CRP)     following full thickness deep endometriosis resection from the bowel, the study aims to     evaluate, in women undergoing this procedure, the effect of extensive abdominal lavage on     abdominal inflammation and post-operative bowel complications.   "
235087|NCT00930709|"     The purpose of this study is to compare efficacy, feasibility and cost effectiveness of     botulinum toxin type A injections to active nine weeks strength training and stretching     program in the treatment of the chronic lateral epicondylitis.      The main hypothesis is that the botulinum toxin type A injections may enable more rapid pain     relief while strength training may provide better functional results and less relapses during     the follow-up.   "
235088|NCT00930722|"     This is a prospective, non-interventional, non comparative drug study. The efficacy of     Quinapril in Asian population has been evaluated, but specifically in Indian patients the     data is sparse. Data in a real world setting in a large population of Indian patients would     shed more light on the safety, tolerability and effectiveness of Quinapril in the Indian     population.   "
235089|NCT00930735|"     The presence of scar within heart muscle can act as a substrate for abnormal rhythm problems     and lead to the developement of heart failure      Clinical significance Correlation with biomarkers and genetic markers   "
235090|NCT00930748|"     The objective of this study is to evaluate imaging quality and correlation with     histopathology in prostate cancer.   "
235091|NCT00930761|"     The purpose of this study is to evaluate the impact of music therapy on breastfeeding rates     among mothers of premature newborns.      Hypothesis: Music therapy applied to mothers of premature newborns increases the rates of     maternal breastfeeding at the time of the infant hospital discharge and at follow-up visits.   "
235092|NCT00930774|"     Many soldiers returning from their recent service in Operation Iraqi Freedom/Operation     Enduring Freedom (OIF/OEF) were exposed to blasts during combat. About 60% of blast-injured     soldiers are diagnosed with traumatic brain injury (TBI), with approximately 18% having a     mild TBI (mTBI). mTBI is associated with many symptoms, including memory problems, headaches,     difficulty concentrating, increased anxiety, and, especially relevant here, reports of     difficulty understanding speech in noisy environments and/or when people speak rapidly. While     problems understanding rapid speech or speech in noise are associated with hearing loss, many     of the OIF/OEF veterans with these complaints have clinically normal hearing. Although there     is no physical damage to their ears, these veterans' hearing problems have a negative impact     on their quality-of-life and functioning. Thus it is incumbent upon the VA to examine     intervention approaches for veterans with normal/near-normal auditory sensitivity and     significant complaints of difficulty hearing. Currently, there is no standard-of-care for     these veterans other than providing information about hearing, hearing conservation, and the     use of communication strategies. Two forms of rehabilitation likely to be more effective than     such an informational-counseling approach are: (1) the use of personal miniaturized Frequency     modulation (FM) systems, and (2) the provision of auditory training with Posit Science Brain     Fitness Program (BFP). Personal FM systems increase the loudness of the speech signal     relative to that of the unwanted noise, while the BFP training improves the ability to listen     by taking advantage of the brain's ability to change (i.e., neural plasticity). In this study     veterans will randomly be selected to receive one of four treatments: (1) FM use alone, (2)     BFP training alone, (3) FM+BFP training combined, and (4) informational-counseling. The     effectiveness of the interventions will be compared using self-report of hearing functioning     on standard questionnaires. Results will contribute to the development of evidence-based     intervention approaches for blast-exposed veterans with reported functional hearing     difficulties and normal/near-normal auditory sensitivity.   "
235093|NCT00930787|"     Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in     a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia     repair is at increased risk of wound related complications, which may be exacerbated by the     choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia     recurrence. It is hypothesized that patients receiving a mesh of biologic origin may     experience fewer wound related complications and hence at least an equal rate of hernia     recurrence, compared to those receiving a synthetic mesh.   "
235094|NCT00930800|"     The purpose of this study was to investigate the effects of exercise training on exercise     capacity, physical activity (PA), health-related quality of life (HRQoL), and the     psychosocial factors affecting PA in sedentary congenital heart defect (CHD) children and     healthy sedentary children. The degree of improvement after exercise training were compared     between CHD children and healthy sedentary children.   "
235097|NCT00930839|"     This study will focus on investigating the nicotinic acid stimulated release of prostaglandin     D2 in normal controls. In subsequent studies, the investigators would like to further explore     this pathway in people with type 2 diabetes. Enhanced blood flow (or flushing) may be     compromised or exaggerated in type 2 diabetes particularly in those with impairment of     autonomic function measured as the respiratory heart rate variability (HRV) of different     frequencies reflecting the balance between the sympathetic and parasympathetic nervous     systems. The investigators hypothesize that the vasodilatory effects induced by nicotinic     acid will be different in glabrous and hairy skin and that autonomic imbalance may alter the     response.   "
235098|NCT00930852|"     The purpose of this study is to determine whether there is an association between migraine in     children and certain patterns of appetite or eating behaviour that may lead to later obesity.   "
235099|NCT00930865|"     To assess the potential pharmacokinetic (PK) interactions of bumetanide and dapagliflozin     following multiple doses of 1 mg bumetanide and 10 mg dapagliflozin in healthy subjects   "
235100|NCT00930878|"     The purpose of this study is to collect real-life data of the Promus™ stent, the Cypher™     stent and the Endeavor™ stent in routine clinical practice, and compare outcomes.   "
235203|NCT00932048|"     Type 2 diabetes mellitus significantly increases the risk for the development of     atherosclerosis. Recently, atherosclerosis imaging with 18F-FDG PET (18F-Fluorodeoxyglucose     Positron Emission Tomography) is useful for tracking inflammation within plaque and     monitoring the response to drug therapy      The purpose of this study is to determine whether FDG-PET is capable of detecting     atherosclerotic vascular inflammation and monitoring the early effects of statins in type 2     diabetic patients. The usefulness of FDG-PET in risk stratification is also investigated.   "
235101|NCT00930891|"     Despite the fact that a substantial response rate may be obtained in small-cell lung cancers     (using double-drug chemotherapy: cisplatin-etoposide, PE), a cure remains an exception. More     aggressive regimens remain controversial and recent attempts at increasing dose-intensity     have been restricted to patients with a more favourable presentation.      Bevacizumab is a humanized monoclonal antibody which binds to VEGF (Vascular Endothelial     Growth Factor). In association with double-drug standard chemotherapies, it has been proven     that bevacizumab can improve survival of previously untreated advanced non-small-cell lung     cancers (NSCLC), compared to chemotherapy without bevacizumab). Such promising effects on     NSCLC deserve to be tested on small-cell lung cancers.      In this trial (IFCT-0802), standard chemotherapy (PCDE or PE) will be compared to     experimental treatment (PCDE or PE + bevacizumab 7.5 mg/kg) for previously untreated SCLC     patients.   "
235102|NCT00930904|"     The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This     evaluation is based on the number of lead-related complications occurring during the study     compared to the number of leads enrolled in the study. The leads will be followed for 5 years     after implant. This study is required by FDA as a condition of approval of the Model 4196 LV     Lead and is integrated within the Product Surveillance Registry (PAN Registry).   "
235103|NCT00930917|"     It is apparent that the head of a preterm infant should not be left uncovered, however it     remains unclear whether covering the head of a preterm baby with plastic wrapping is     effective in preventing heat loss.      We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate     if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive     wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after     admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap     prevents postnatal heat loss.   "
235104|NCT00930930|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving chemotherapy together     with everolimus before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed. It is not yet known whether cisplatin and paclitaxel are     more effective when given together with or without everolimus in treating patients with     breast cancer.      PURPOSE: This randomized phase II trial is studying how well cisplatin and paclitaxel work     when given together with or without everolimus in treating patients with stage II or stage     III breast cancer.   "
235105|NCT00930943|"     The purpose of the study is to determine whether extended-release oxymorphone hydrochloride     taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts     cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB)     tests, to a greater extent than when taking under conditions of fasting.   "
235106|NCT00930956|"     This study is to determine whether different types of resistant starch have different effects     on blood glucose in healthy adults.   "
235107|NCT00930969|"     The purpose of ST Detect study is to evaluate whether naturally occurring spontaneous     coronary events and exercise induced cardiac ischemia, give rise to detectable changes on     intracardiac electrogram (EGM) signals in patients that are indicated for an Implantable     Cardioverter Defibrillator (ICD) who have coronary artery disease.   "
235108|NCT00930982|"     The purpose of this study is to find out if bacterial load in the airways can be reduced     after inhalation of ciprofloxacin for 28 days.   "
235109|NCT00930995|"     Hepatitis C is the most common reason for liver transplantation in the United States and     affects nearly 4 million Americans. Treatments for hepatitis C are available but are poorly     tolerated and are not always effective. Morbidity and mortality from hepatitis C are related     to the development and progression of hepatic fibrosis to cirrhosis and end stage liver     disease. Efforts to block progression of liver disease would thus result in prevention of     morbidity and mortality as well as costs incurred by the health system in the care of these     conditions.      Scar tissue in the liver is secreted by a type of cell, called the stellate cell, in an     activated state. This cell carries a receptor for angiotensin, a hormone, when activated. If     this receptor is blocked, the cell becomes inactive and does not participate in scar tissue     formation. Thus, we hypothesize that using a drug such as candesartan, which blocks     angiotensin receptors, should result in less scar tissue formation in the livers of patients     with hepatitis C.   "
235110|NCT00931008|"     This is a multi-center, randomized, blinded, two-period, two-sequence, crossover study, with     a minimum 3-week washout period between treatments.The study is designed to evaluate the     bioequivalence of SID530 to Taxotere.      It will be conducted in study participants with locally advanced or metastatic NSCLC who have     failed platinum therapy and also in participants with locally advanced or metastatic breast     cancer who have failed at least one line of chemotherapy.      Eligible study participants must be planning to have at least two consecutive 21-day cycles     with 75 mg/m2 docetaxel monotherapy.      The duration of study participation will be approximately 7 weeks. The study has three study     phases: Screening (<=1 week), Cycle 1 (21 days), and Cycle 2 (21 days).   "
235111|NCT00931021|"     This is a pilot research study examining the use of varenicline (Chantix) and the nicotine     patch. The study is designed to find out whether one of these medications is more effective     for smoking cessation with head and neck cancer patients. The study has three parts: 1) two     intake sessions; 2) an 8-week treatment phase, and 3) a 3-month follow-up.   "
235112|NCT00931034|"     The purpose of this study is to examine the effectiveness of the South Beach Diet and     products compared to the American Diabetic Association Diabetes Meal Plan.   "
235113|NCT00931060|"     The purpose of this study is to determine whether Branched chain Amino Acids enhances the     uptake of ammonia in muscle tissue.   "
235114|NCT00931073|"     This study will evaluate the potential for a drug-drug interaction of Dimebon with     ketoconazole and omeprazole, potent inhibitors of the drug metabolizing enzymes CYP3A4 and     CYP2C19, respectively.   "
235115|NCT00931086|"     An expanded access trial of belimumab for named patients who participated in LBRA99.   "
235116|NCT00931099|"     Sleep disordered breathing (SDB) is a frequent disorder characterized by some combination of     repeated events of partial or complete upper airway obstruction during sleep, disruption of     normal ventilation, hypoxemia, and sleep fragmentation. When untreated, SDB is associated     with serious cardiovascular and neurobehavioral morbidities. Many physiologic changes that     occur during pregnancy may compromise the respiratory system and place women at risk for     developing SDB. Indeed, snoring has been reported in up to 46% of pregnant women. Preliminary     evidence suggests that SDB is associated with the hypertensive conditions of pregnancy and     that oxidative stress and endothelial dysfunction are mechanisms important in the development     of both conditions. Moreover, early reports in animals and in humans suggest that maternal     SDB may affect the developing fetus and that the intermittent hypoxia and increased     sympathetic activity induced by SDB could potentially contribute to adverse maternal-fetal     outcome. However, previous reports have focused on crude and non specific measures of fetal     outcome such as birth weight and APGAR (Appearance, Pulse, Grimace, Activity, Respiration)     score and currently there is no data on the mechanisms underlying the adverse effect of     maternal SDB on the fetus and the newborn infant.      Hypothesis: SDB during pregnancy imposes a risk to the developing fetus and the newborn     infant through mechanisms mediated by maternal hypoxia.      Objectives:        1. To prospectively investigate the incidence and severity of SDB during pregnancy using an          objective tool, i.e., overnight polysomnography (PSG) or at-home sleep study using          portable device in a large cohort of pregnant women.        2. To examine the effect of maternal SDB on fetal and neonatal outcome. Methods: 300 women          in the third trimester of a singleton uncomplicated pregnancy, who attend a low risk          obstetric surveillance will be recruited. Hundred women hospitalized at the Antenatal          department due to pregnancy related hypertensive disorder, intrauterine growth          restriction (IUGR), diabetes mellitus or premature labor will also be recruited. In          addition, 200 women of a singleton uncomplicated pregnancy will be recruited during          labor at the delivery room. All participants will be asked to complete a designated          sleep questionnaire. Based on the questionnaires, women in the third trimester will          undergo a sleep study. Medical records review will be conducted after delivery and will          include information of maternal blood pressure, labor duration, route of delivery,          infant birth weight and APGAR score. Placentas will be collected immediately after          delivery from all women. Cord blood will be obtained immediately after delivery and will          be analyzed. Post-natal neurobehavioral evaluation will be conducted. Data analysis will          be performed on 4 population subgroups: (1) Sleep study proven SDB, (2) Sleep study          proven non-SDB, (3) SDB per questionnaire, (4) non-SDB per questionnaire. Comparisons of          fetal outcome measures according to group assignment will be performed. In addition, the          association between the severity of SDB based on sleep studies (degree of hypoxemia,          degree of sleep fragmentation, amount of respiratory events) and outcome measures will          be performed.   "
235117|NCT00931112|"     The study is designed to investigate individualized exercise training effects on arterial     function, walking ability and quality of life in subjects with peripheral arterial disease     post surgery.   "
235121|NCT00931164|"     WHO: The investigators are recruiting children and young adults to participate in a research     study who:        1. Have been diagnosed with Alternating Hemiplegia of Childhood (AHC)        2. Are between the ages of 6 months - 25 years old        3. Have at least three 10-minute-long AHC episodes during a typical week        4. Can commit to 12 weeks of completing of a daily log describing AHC episodes and to a          multi-night hospital stay at the University of Utah Center for Clinical and          Translational Science (CCTS)      WHY: The goal of this study is to evaluate whether the study drug can safely and effectively     decrease AHC episodes and improve the quality of life of individuals with AHC.      WHAT and WHERE: This study involves at least 12 weeks of completing and submitting daily AHC     Episode Logs and a five-day hospital stay at the University of Utah CCTS.      There are 4 phases of the study, and they include:        1. Six weeks of daily log completion prior to starting study drug        2. Five day stay at the University of Utah CCTS        3. Six additional weeks of daily log completion while using study drug at home        4. One day clinic visit to the University of Utah for follow up      COMPENSATION:      There is no fee to participate. All procedures performed specifically for this study will be     covered by the study and will not be billed to you or your insurance company.      The study drug will be dispensed to you free of charge. Meals and lodging at the study site     will be provided free of charge for the study participant and one care provider.     Additionally, the research team will assist subjects with booking and obtaining free     transportation, such as an airline tickets, to and from the study site.   "
235122|NCT00931177|"     This is a study to evaluate the validity, reliability, and clinical usefulness of a new     dehydration scoring system (DSS).   "
235123|NCT00931190|"     The objectives are to evaluate the effectiveness of treatment of cervical intraepithelial     neoplasia (CIN) by loop electrosurgical excision procedure using persistence of human     papillomavirus (HPV) as outcome, and to perform a long-term follow-up on the ability of HPV     testing, as compared to cytology, to predict recurrence of high-grade CIN.   "
235124|NCT00931203|"     This is a single arm phase II trial with combined celecoxib, tegafur-uracil, folinate and     preoperative radiotherapy for patients with locally advanced rectal cancer. The primary end     point is pathological complete response (pCR) rate. The secondary endpoints are toxicities of     combined celecoxib and chemoradiation, negative resection margin rate, clinical tumor     response by magnetic resonance imaging (MRI), sphincter preservation rate, disease-free     survival and overall survival.   "
235125|NCT00931216|"     This study seeks to determine the most effective way to reach and provide pregnant women with     accessible, comprehensive, and high quality HIV care and treatment.   "
235126|NCT00931229|"     This is a single-arm study. Key eligibility criteria include (1) newly diagnosed, diffuse     large B-cell or follicular cell non-Hodgkin's lymphoma; (2) negative test for hepatitis B     surface antigen (HBsAg) and positive for antibody to hepatitis B core antigen (anti-HBc); (3)     adequate bone marrow, liver, and kidney function. All eligible patients will receive     rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy     according to current treatment guidelines. The primary endpoint of this study is the     incidence of hepatitis B virus (HBV) reactivation, defined by a greater than 10-fold     increase, compared with previous nadir levels, of HBV DNA during rituximab-CHOP chemotherapy     and within 1 year after completion of the last course of rituximab-CHOP chemotherapy.     Patients who have HBV reactivation during the study period will receive free entecavir     treatment, one of the standard treatment for chronic hepatitis B, for 48 weeks. The secondary     endpoints include the incidence of hepatitis flare, defined as a greater than 3 fold increase     of serum alanine aminotransferase (ALT) level that exceeded 100 IU/L, and the efficacy and     safety of rituximab-CHOP chemotherapy.      In the T1408 study we enrolled patients with newly diagnosed lymphoma who were HBsAg (-) and     anti-HBc (+) and were to receive rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine,     prednisolone)-based chemotherapy. Key findings of this study included (1) HBV reactivation,     defined as a greater than 10-fold increase in HBV DNA compared with previous nadir levels,     occurred to 10-20% of patients, depending on the sensitivity of the HBV DNA tests; (2) no     HBV-related death with the prompt anti-viral therapy upon HBV reactivation; (3) patients with     HBV reactivation were associated with poorer progression-free survival and overall survival;     (4) serological breakthrough (i.e., re-appearance of HBsAg) is an important predictor of     HBV-related hepatitis flare.      In this amendment we will enroll more patients to clarify the above findings: (1) the     association between HBV reactivation and survival; (2) diagnostic value of quantitative HBsAg     and anti HBc tests on HBV reactivation; (3) whether host factors (DNA polymorphism) may help     predict HBV reactivation. A larger patient cohort is needed to identify (1) baseline features     that may help predict HBV reactivation, and (2) on-treatment features that may help timely     anti-viral therapy.   "
235127|NCT00931242|"     The objective of this study is to evaluate the efficacy of apremilast in patients with     recalcitrant atopic or contact dermatitis.   "
235198|NCT00931983|"     --Participation open to all Canadian residents--      The purpose of this study is to address how well children with incomplete spinal cord     injuries of greater than 12 months duration who remain non-functional ambulators improve     through body weight assisted treadmill training (BWATT).   "
235128|NCT00931255|"     The objective of this study is to evaluate the safety and efficacy of conversion from     tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft     function (DGF)and slow graft function (SGF) in improving graft function and delaying chronic     allograft nephropathy. The investigators hypothesize that conversion from tacrolimus to     sirolimus in renal transplant recipients with DGF/SGF in early months after surgery will     improve graft function and decrease the progression of graft fibrosis.   "
235129|NCT00931268|"     The study is being undertaken to establish the effectiveness and safety of Macrolane volume     restoration factor 30 (VRF30) when used for treatment of HIV-infected subjects with buttocks     lipoatrophy.   "
235130|NCT00931281|"     The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of     multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir     in healthy volunteers.   "
235131|NCT00931294|"     The hypothesis was that a one-year experience of choir singing once a week is more beneficial     than group discussions to saliva concentration of testosterone.   "
235132|NCT00931307|"     The purpose of this trial is to assess the performance of a Lotrafilcon A contact lens over a     3-month period.   "
235133|NCT00931320|"     An observational, non-interventional, multi-centre study to provide further information on     the ratio of LDL-C to HDL-C improvement after statin treatment in Korean patients group.   "
235290|NCT00936611|"     The purpose of this research study is to assess the response rate of LBH589 in patients with     relapsed or refractory Waldenstrom's Macroglobulinemia. LBH589 is a newly discovered compound     that has killed Waldenstrom cells in laboratory studies, however, it is not known if LBH589     will show the same activity in people with Waldenstrom's Macroglobulinemia. This drug has     been used in research for the treatment of other types of cancer, such as multiple myeloma.   "
235291|NCT00936624|"     This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent     asthma.   "
235134|NCT00931333|"     The macroporous calcium phosphate cement, MCPC, which composition is close to bone, is     malleable and biocompatible, and has intrinsic radio opacity and good ability to undergo     mechanical constraints. After the filling of the bone cavity, the cement hardens.     Interestingly, this calcium phosphate cement has no exothermic hardening (on the contrary,     the ordinary cements used nowadays cause necrotic lesions in tissues around during this     phase) and favours vascularisation, cellular colonisation and bone healing. Thanks to its     resorbability, the MCPC cement is replaced little by little by a physiologic bone. This last     property is very important for young people needing a vertebroplasty after a traumatism.      Thus, it will be tested in a low-invasive surgery, a non-percutaneous vertebroplasty,     consisting in filling with the MCPC the body of the broken vertebra, after its stabilization     thanks to 4 interpedicular screws. This protocol will be proposed to patients 1 to 3 weeks     after the trauma having caused the fracture.      The follow up will last 12 months with 5 visits (2 days, and 3, 4, 6 and 12 months after     vertebroplasty), 2 CT scanners before inclusion and at 12 months, 2 EOS (ultra low dose     imager replacing classical radiography) at 5 and 12 months, questionnaires (visual analogic     scale for pain, and quality of life with OSWESTRY and SF36 scales) before inclusion and at 2     days, and 3, 4, 6 and 12 months, and biological exams (CRP/VS, for inflammation) at each     visit except 2 days after surgery. An osteodensitometry will be performed at 3 months.   "
235135|NCT00931346|"     This study will evaluate the safety and acceptability of intermittent and daily pre-exposure     prophylaxis (PrEP) regimens with FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) in HIV     discordant couples, and it will directly compare adherence and intracellular drug levels in     daily and intermittent PrEP recipients. It will also evaluate the relationship between drug     adherence, sexual behavior and intracellular drug levels with an intermittent PrEP regimen.     In addition it will evaluate the relationship between adherence to an intermittent PrEP     regimen and timing of sexual activity in relation to PrEP dosing. The pilot will use     objective medication event monitoring (MEMS) adherence measurement and evaluate the     feasibility of newer adherence measurements such as hair sampling and plasma drug levels.     This study will also evaluate the feasibility of using text messaging (SMS) to collect sexual     activity data in an African setting. It will allow study teams and communities to prepare for     potential subsequent larger trials of intermittent PrEP. The study is not sized to evaluate     efficacy. If the intermittent PrEP regimen is safe, feasible in terms of adherence, and     achieves intracellular drug levels similar to daily PrEP, the data could be used to design a     larger phase 2 study with one or more intermittent PrEP regimens. The goal of such a larger     trial would be to provide bridging data if daily PrEP regimens are found to be effective or     to prepare for efficacy or non-inferiority trials of intermittent versus daily PrEP.      Investigation of immune responses associated with FTC/TDF will also be evaluated in the pilot     study. The proportion of volunteers on FTC/TDF with HIV-specific immune responses, due to     exposures that did not lead to established HIV infection, will be assessed at 2-3 time points     and compared to responses in volunteers assigned to placebo. Immune responses may be     correlated with risk behavior and host factors, such as human leukocyte antigen (HLA) type.     As noted above, very few HIV infections are expected to occur during the study, so     correlation of HIV-specific immune responses and protection from infection or attenuation of     disease progression will not be possible until a larger study is conducted.   "
235136|NCT00931359|"     This is a prospective, multi-center, parallel, randomized, blinded study. The study has two     groups, where in one study group the subjects receive treatment for axillary hyperhidrosis     (excessive underarm sweating) with the DTS-G2 System in both axilla (treatment group). The     other study group receives a sham treatment in both axilla where the subjects will have the     same procedure performed but no energy from the device will be applied (sham group).     Subjects will be randomized in a 2:1 ratio (treatment group: sham group).      Subjects enrolled in the study will be blinded regarding which study group they are in. The     study hypothesis is that subjects that receive the treatment will have a reduction in     underarm sweating compared to those in the sham group, as measured by a quality of life     questionnaire.      All subjects will undergo follow up assessments at 14 days, 30 days, 3 months and 6 months     post final treatment session. Subjects randomized to the treatment group will also have     follow-up visits at 9 months and 12 months post final treatment session.   "
235137|NCT00931372|"     The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase     and improves second phase insulin response in subjects with diabetes mellitus type 2.   "
235138|NCT00931385|"     The study is intended to characterize the lung function profile of BI1744 in COPD patients     where patients will perform pulmonary function tests at regular intervals for 24 hours at the     end of a 6 week treatment period. Each patient will receive all four treatments.   "
235139|NCT00931398|"     The purpose of the proposed study is to determine the effectiveness of methylphenidate HCl     (Concerta) in college students with ADHD. This study will consist of 110 college students     between the ages of 18 and 25 who are enrolled full-time in a local or junior college. The     study consists of an 8-week double-blind, placebo-controlled trial of placebo versus     methylphenidate HCl (Concerta®) followed by a 10-week extension of open label methylphenidate     HCl (Concerta®).   "
235199|NCT00931996|"     DESCRIPTION: (Verbatim from the Applicant's Abstract) Abnormalities of eye movement control     and spatial cognition are well-established deficits in schizophrenia. However, the regional     disturbances in brain function causing these deficits are not yet known. This application     proposes a series of integrated behavioral studies designed to identify causes of deficits in     schizophrenia.   "
235200|NCT00932009|"     The purpose of this study is to determine the prevalence and type distribution of genital     human papillomavirus (HPV) infection in Tanzanian men.   "
235151|NCT00931554|"     Despite a substantial decrease in postoperative mortality, morbidity after pancreatic     resections is still high, even at high-volume centers. It has been recently suggested that     early removal of postoperative drainages is associated to a decreased rate of intra-abdominal     complications, with particular regard to pancreatic fistula. Furthermore, our research group     demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a     cardinal role in predicting the developement of abdominal complications, including pancreatic     fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were     considered at low risk of fistula. Therefore, the investigators designed a randomized     prospective trial on early (postoperative day 3) versus standard (postoperative day 5)     drainages removal after pancreatic resections in patients at low risk of developing     pancreatic fistula (AVD < 5000 IU/L in postoperative day 1) to test whether drainages per     se influence postoperative complication rates and to eventually validate a fast-track policy     in pancreatic resections.   "
235292|NCT00936637|"     The purpose of this study is to assess growth in infants who are fed an extensively     hydrolyzed formula.   "
235293|NCT00936650|"     This randomized, placebo-controlled study in patients with primary HPT was designed to     evaluate the efficacy, safety, pharmacokinetics, and health-related quality of life (HRQOL)     of AMG 073 when administered 2 times a day (BID). The study consisted of 3 phases: a 12-week     dose-titration phase, a 12-week maintenance phase, and a 28-week follow-up phase.   "
235140|NCT00931411|"     Atopic dermatitis is one of the most frequent skin diseases. The disease is often worst     during winter months when the skin is drier. Mild to moderate cases of atopic dermatitis are     often controlled by a moisturizer alone. The use of moisturizers has been shown to have     beneficial effects on atopic dermatitis. It can break the dry skin cycle by hydrating the     upper layer of the skin which may prevent the recurrence of the disease and can reduce the     use of cream or ointment medications such as corticosteroids. Formulation 609580 20 was     developed to keep the moisturizing efficacy of formulation 609209 but to improve its     tolerance and cosmetic acceptability (easier to apply, nicer texture, etc.). The new     formulation contains the same quantity of shea butter and glycerin but in a different     excipient (inactive substance) than the commercial product. In addition, vitamin B3 was added     to see if it could help in reducing itching.      The purpose of this study is to determine the safety and efficacy of two study products in     children with atopic dermatitis. One of the study products (formulation 609580 20) is not     commercially available (outside of clinical trials such as this one). The other study product     (formulation 609209) has been approved in Canada and is currently available commercially     under the trade name Lipikar Baume.      For this study the child will be randomly assigned to one of the following two groups:        -  Group 1: 50 children will receive formulation 609209, the commercial formula for 42 days          and will receive formulation 609580 20, the new formula, for 14 days.        -  Group 2: 50 children will receive formulation 609580 20, the new formula, for 42 days          and will receive formulation 609209, the commercial formula, for 14 days.   "
235141|NCT00931424|"     A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive     surgery on Primary Chronic Venous Insufficiency.   "
235142|NCT00931437|"     Lactic acid bacteria produce a mixture of higher menaquinones, including menaquinone-9 (MK-9)     and menaquinone-10 (MK-10). Vitamin K1 (phylloquinone) is normally present in chloroplasts in     green vegetables. A new dairy product is developed containing both vitamin K1 and     K2-vitamins. However, the extent to which the various forms of vitamin K are absorbed from     such a mixture is not known. In this study the absorption profile of phylloquinone and     menaquinones from this new dairy product containing several K-vitamins is investigated. This     study describes a dietary intervention experiment for one single cocktail containing several     K-vitamins as part of a dairy product.   "
235143|NCT00931450|"     RATIONALE: Sunitinib malate and exemestane may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Giving sunitinib malate and exemestane before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed.      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of     sunitinib malate to see how well it works when given together with exemestane in treating     postmenopausal women with breast cancer.   "
235144|NCT00931463|"     The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI     regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and     2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and     raltegravir.      The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks.      The primary endpoint is virological: a comparison of virological suppression in plasma < 200     copies/mL between the randomized arms after 48 weeks.      Secondary and exploratory endpoints include virological, immunological, safety, clinical,     metabolic, drug adherence, drug resistance and quality of life.   "
235145|NCT00931476|"     This trial was conducted in the United States of America (USA). The aim of this clinical     trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian     subjects, and to identify somatostatin-related adverse events.   "
235146|NCT00931489|"     The investigators hope to determine if wet AMD patients differ from patients with dry AMD     or normal eyes in the production of anti-retinal pigment epithelium (anti-RPE) or     anti-retinal antibody formation. To explain: the immune system can make antibodies that     attack our own cells, specifically the RPE and the retina. Normally the RPE and retinal cells     are ignored by the immune system, but when disease occurs, immune reactions can occur, making     an autoantibody that can attack the patient's own cells and make things worse. This     production of autoantibodies that react with our own RPE and retinal cells is what the     investigators want to test in this proposal to see if they may contribute to, or are     responsible for, a poor response to treatment.      The investigators also want to know how those patients who initially respond to the     standard-of-care treatment, ranibizumab injections, differ in the production of anti-RPE or     anti-retinal antibody formation, from those patients who do not respond initially after 4     consecutive injections.   "
235147|NCT00931502|"     The purpose of this study is to better understand what treatment methods result in the best     outcomes for patients who have heart attacks due to blood clots forming within stents.   "
235148|NCT00931515|"     The NuBac device is indicated for reconstruction following nucleotomy in skeletally mature     patients at least 18 years of age with symptomatic single level degenerative disc disease     (DDD) at L4/L5 only.      DDD is defined as discogenic back pain with or without leg pain; with degeneration of the     disc as confirmed by patient history, physical examination, radiographic studies showing:     decreased disc height, contained herniated nucleus, vacuum phenomenon (dark disc) OR positive     discography at the affected level.      These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level     and should have failed at least six months of conservative, non-operative care.      Demonstrate non-inferiority compared to ProDisc.   "
235149|NCT00931528|"     RATIONALE: Tadalafil may help prevent erectile dysfunction in patients with prostate cancer     that has been treated with radiation therapy. It is not yet known whether tadalafil is more     effective than a placebo in preventing erectile dysfunction.      PURPOSE: This randomized phase III trial is studying tadalafil to see how well it works     compared with a placebo in preventing erectile dysfunction in patients with prostate cancer     treated with radiation therapy.   "
235150|NCT00931541|"     The aims of the study are to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of AZD6088 following single ascending dose administration in healthy male     and non-fertile females.   "
235419|NCT00929214|"     The goal of this clinical research study is to find out if adding local therapy (surgery     and/or radiation) to standard therapy (chemotherapy or endocrine therapy) in the treatment of     patients with metastatic breast cancer can help to control the disease for a longer period of     time than standard therapy alone.   "
235152|NCT00931567|"     This study is a clinical, multicentric, randomised open trial. The objective is to evaluate     the efficiency, in terms of wound healing speed, of peroperative application of autologous     platelets gel versus standardized wound dressing. The wound Healing model used in this study     is the  open palm  surgical treatment of Dupuytren's disease.      Dupuytren's disease is a fibroproliferative disease of the palmar and digital fascia of the     hand that may lead to a fixed flexion contracture of the fingers.      The main indication for surgery is the loss of finger extension. In some cases of palmar     Dupuytren's disease the surgical removal of diseased tissues may lead to a cutaneous loss of     substance ( open palm technique ). This loss of substance is treated using vaseline     dressing and the wound healing is obtained in 4 weeks.      Autologous platelets gel (Platelet Rich Fibrin) is obtained from the patient's own blood.     Some recent studies have shown that it speeds up the wound healing and enhances the quality     of the scar.      PRF belongs to a new generation of autologous platelet gel that are easily obtained after     centrifugation of patient's own blood.      The Platelet Rich Fibrin (PRF) contains many wound healing factors : Three pro inflammatory     cytokines ( IL1,IL6, TNF-alpha) , one anti-inflammatory cytokine (IL4) and a growth factor     (VEGF).      The study will be running on 60 days, starting from the operation day. The wound healing     evaluation will be achieved at day1, day2, day7, day14, day 21 day 28 and day 60.      The inclusion criteria are : age over 18, Dupuytren's disease with an indication of surgical     treatment using the open palm technique, patients having signed the agreement form.      80 patients will be included in the study and divided into 2 groups . The first group of     patients will receive PRF and the other group will receive vaseline dressings.      The speed and the quality of wound healing will be compared.We will also compare the number     of patients with a complete wound healing at day 21 . Moreover,we will evaluate the pain     during the dressings' change and the bleeding of the palmar wound.      For the wound healing speed , a difference of 7 days between the two groups will be     considered as statistically significant.      Statistical analysis will be achieved using Chi2 test and Logrank test.   "
235153|NCT00931580|"     While a large percentage of children have low blood vitamin D levels, the significance of     these low levels and the impact on health is unclear. The purpose of this project is to     determine the effects of varying doses of vitamin D supplementation over 12 weeks on blood     indicators of health in white and black children, aged 9 to 13 years, from both the northern     and southern US.   "
235154|NCT00931593|"     Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of     gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in     healthy volunteers. They are induced by meal.      The gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe.      Esophageal high resolution manometry with solid state sensors was developed in the 90s. The     examination is easier and more accurate than perfused manometry. The aim of this study is to     validate in healthy volunteers the use of high resolution manometry (Sierra Scientific     Instruments, California CA) to detect tLESr.   "
235155|NCT00931606|"     Anemia can be caused by the chemotherapy treatment that is used to treat metastatic breast     cancer. This study will be used to find out if ACE-011 can help treat chemotherapy induced     anemia in patients with metastatic breast cancer.   "
235156|NCT00931619|"     Objective: To study the relative balance of GABA (A) binding potential and glutamate     utilization in subjects with localization-related epilepsy with and without depression,     subjects with major depressive disorder alone, and in subjects with generalized epilepsy     (expected not to have significant comorbid depression). Pilot data shows that GABA(A) binding     potential and glutamate utilization are tightly coupled in healthy subjects particularly in     the mesial temporal lobe. We hypothesize that subjects with epilepsy will not exhibit the     same degree of coupling, and that subjects with both epilepsy and depression will exhibit an     even more pronounced decoupling.      Study Population: Subjects aged 18-55 with localization-related epilepsy with and without     depression, subjects with generalized epilepsy, subjects with major depressive disorder (MDD)     alone, and healthy controls.      Design: This is a neuroimaging study, using positron emission tomography (PET) with     [11C]flumazenil, to measure GABA(A) binding potential, and [18F]fluorodeoxyglucose, to     measure glucose utilization (reflective of neuronal glutamate release) Magnetic resonance     spectroscopy (MRS), will be used to measure GABA and glutamate in the mesial temporal cortex,     and corroborate the PET results. Structural magnetic resonance images (MRI) will be obtained     for MRS localization and partial volume correction of PET images.      Outcome measures: The binding potential of GABA(A), the regional rate of glucose metabolism,     and the levels of GABA and glutamate as measured by MRS. Patients will be stratified by     seizure type and depression ratings.   "
235157|NCT00931632|"     This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will     attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive     pressure support at any point during days 5 to 14 after birth may benefit from treatment with     iNO.   "
235158|NCT00931645|"     Phase III trial evaluating the role of autologous stem cell transplantation in previously     untreated patients under 65 years with stage B and C B-cell chronic lymphocytic leukemia.      Endpoints of the trial :        -  major : progression free survival at 3 years        -  secondary : overall survival, tolerance, prognostic factors according to baseline          clinical stage and biological characteristics (IgHv mutational status, expression of          ZAP70 and CD38, cytogenetics).   "
235159|NCT00931671|"     The study is designed to investigate (1) the effects of task-oriented aerobic exercise     training on cardiorespiratory fitness, cerebral blood flow, oxygenation, functional     performance, and physical activity in patients with chronic stroke. (2) the association     between outcomes   "
235201|NCT00932022|"     This study evaluated the effectiveness of trospium chloride extended release (XR) in obese     female patients with overactive bladder (OAB). Patients received either placebo and trospium     chloride XR or placebo only. The study assessed the change from baseline in urinary     frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The     study was 14 weeks in duration.   "
235434|NCT00938184|"     The primary purpose of this study is to to assess the pharmacokinetics of paroxetine after     single doses of paroxetine CR at the dose levels of 12.5, 25 and 50mg in healthy Japanese     male volunteers.   "
235172|NCT00931853|"     Primary Objective:        -  To evaluate the clinical efficacy of Naturetti (jelly sugar free)        -  To test medication on subjects who suffer chronic functional constipation in 30 days          use.      Secondary Objectives:        -  To demonstrate the clinical tolerability when daily used (repeated doses) of the          components of the study drug. The components will be evaluated by the adverse events          occurrence classified by possibly related, probably related and definitely related        -  To demonstrate the clinical tolerability of the study medication by the continuous use          during the second phase study        -  To identify any adverse events related to the study drug        -  To identify any drug interaction.   "
235173|NCT00925964|"     To investigate whether the presence of a Systolic pressure index (<0.9 or> 1.4) is a marker     of risk of cardiovascular events after peri-operative high-risk surgery outside the cardiac     and vascular surgery.   "
235160|NCT00931697|"     Mefloquine is a quinolinemethanol antimalarial that is effective as therapy and prophylaxis     for all species of malaria infecting humans, including multi-drug resistant Plasmodium     falciparum. The marketed anti-malaria drug consists of two enantiomers of mefloquine.      Mefloquine's clinical utility has been impaired by its association with neuropsychiatric side     effects. The pharmacological basis of mefloquine's side effects is not known but two of the     most reported hypotheses relate to its action on (i) the adenosine receptor and (ii) its     effect on the cholinesterase enzyme. For both of these mechanisms, there is a significant     stereoselective activity of the two enantiomers. In vitro studies show that the (-) isomer is     50-100 fold more potent towards adenosine receptors compared with the (+) isomer. In     addition, (-)-mefloquine has considerably more anti-cholinesterase activity. It has therefore     been hypothesised that (+)-mefloquine may have a better central nervous system (CNS) safety     profile compared with either the racemate or (-)-mefloquine.      This study is a randomized, ascending dose, double-blind, active and placebo-controlled,     parallel group study in healthy male and female volunteers designed to investigate this     hypothesis and to describe the comparative pharmacokinetics of the racemate and the single     enantiomer.   "
235161|NCT00931710|"     This study will compare the antihypertensive efficacy and safety of a     valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2     systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and     less than 200 mmHg).   "
235162|NCT00931723|"     The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added     to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in     treating acute mania and if so, how it compares with placebo (a non-active capsule, like a     sugar pill, that looks like lithium).   "
235163|NCT00931736|"     On a global scale, tuberculosis (TB) is the single most important infectious cause of     morbidity and mortality. The World Health Organization has estimated that one-third of the     entire world's population carries latent TB infection. A key TB control strategy is therapy     of latent TB infection (LTBI). The current standard regimen is 9 months of Isoniazid (9INH).     This regimen has excellent efficacy if taken regularly, but its effectiveness is     substantially reduced by poor compliance. Serious side effects, such as hepato-toxicity can     occur. Three shorter alternatives have been recommended: 6 months INH (6INH), 2 months     Rifampin - Pyrazinamide (2RIF-PZA) and 4 months Rifampin (4RIF). The regimen of 6INH is less     efficacious than 9INH, while 2RIF-PZA has been largely abandoned because of serious toxicity.     Based on some evidence in treatment of LTBI, and extrapolating from extensive experience with     treatment of active TB, it is believed that 4RIF has similar efficacy as 9INH. Therefore, the     investigators are initiating the first multi-site international randomized trial that will     compare the effectiveness of 4RIF and 9INH in preventing active tuberculosis.   "
235164|NCT00931749|"     The purpose of this study is to determine the effects of low intensity ultrasound therapy     over the cartilage morphology (thickness and volume) of patients with mild or moderate knee     osteoarthritis.   "
235165|NCT00931762|"     This study will assess the safety and efficacy of Panobinostat as a single agent in the     treatment of Primary Myelofibrosis, Post-Polycythemia Vera and Post-Essential     Thrombocythemia. There will be two cohorts - patients with JAK2 mutation and patients without     JAK2 mutation.   "
235166|NCT00931775|"     The purpose of this study is to examine whether the speed of the clinical antidepressant     action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day,     tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy.   "
235167|NCT00931788|"     People who have had a stroke or transient ischemic attack (TIA or mini-stroke) are at high     risk of having another stroke or a heart attack. Conditions like high blood pressure and high     cholesterol, along with other lifestyle behaviors (e.g., smoking), substantially increase the     risk of stroke and heart disease. Aggressive treatment of these risk factors however, can     significantly reduce the chance of another stroke, heart attack or death.      This study will look at different ways to optimize blood pressure and cholesterol levels and     educate people about positive lifestyle changes.   "
235168|NCT00931801|"     The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and     satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen     for participants fully suppressed on an atazanavir/ritonavir based highly active     antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several     pharmacologic factors support this concept including the favorable drug interaction between     atazanavir and raltegravir. Participants will be randomized to either continue on their     current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus     raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice     daily). Participants will be followed for 48 weeks for safety, tolerability, and     satisfaction. After baseline, the participants will have six clinic visits for evaluation and     labs.   "
235169|NCT00931814|"     The purpose of this study was to investigate the effects of 8-week exercise training on     depression symptoms, physical functions, and quality of life in the community-dwelling     elderly.   "
235170|NCT00931827|"     The study examines the use of Mirena or Implanon for long-term contraception in women. The     duration of therapy use is the key focus of the study. Also, any reasons for discontinuation     and the safety profile will be examined. In addition, patients are asked to fill out a short     questionnaire about their menstrual bleeding before and during therapy.   "
235171|NCT00931840|"     This is a Phase 2, multicenter, multiple-arm, open-label study to evaluate the efficacy,     safety, and tolerability of EZN-2208. EZN-2208 will be administered as a single agent in     patients with K-RAS mutations in the tumors. Patients with wild type K-RAS in tumors will be     randomized to EZN-2208 + cetuximab or to standard of care (Camptosar® + cetuximab), patients     must have failed regimens containing irinotecan (Camptosar®, CPT-11), oxaliplatin     (Eloxatin®), and fluoropyrimidine.      After discontinuation of study treatment, patients will receive care as considered     appropriate by the investigator. Patients will continue to be followed for disease     progression, subsequent anticancer therapy, and survival.   "
235264|NCT00936273|"     The purpose of this study is to determine the double loop index (DLI) threshold with optimal     sensitivity and specificity. The investigators hypothesize that the DLI gives a better     reflection of the pathophysiology of the disease than the apnea-hypopnea-index (AHI).   "
235174|NCT00925977|"     A randomized, crossover, open study in order to compare treatment satisfaction with insulin     Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children     and adolescents with type 1 diabetes.      The study will include two consecutive periods: 2 weeks run in period and 24 weeks     intervention period, divided into two separate treatment periods of 12 weeks. According to     randomization, each patient will be treated consecutively with both treatment arms: 12 weeks     with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad than     12 weeks with insulin Glargine. Patients will complete DTSQ (Diabetes Treatment Satisfaction     Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.   "
235175|NCT00925990|"     The study is intended to determine whether CTS-1027 either alone or in combination with     ribavirin is safe and effective in Hepatitis C patients who have not previously been treated     with interferon.   "
235176|NCT00926003|"     Research Topic: Over 110,000 HIV Ugandan children are at risk for neurocognitive disorders     due to the progressive encephalopathy of CNS HIV infection. Even if clinically stable, these     children can have motor, attention, memory, visual-spatial processing, and other executive     function impairment. One-hundred and fifty school-age children with HIV in Kayunga District,     Uganda, will serve as our participants. Fifty of these children will be randomly selected to     receive 24 training sessions of a computerized cognitive rehabilitation therapy (CCRT)     program called Captain's Log, marketed mostly for American children with attention or     learning problems. A locked version of Captain's Log which does not direct the child's     training in a progressive manner will be administered to a second active control group;     while a third group will be a passive control group not receiving any computer training     intervention. Study Aim 1: To compare the neuropsychological benefit of 24 training sessions     of Captain's Log CCRT to the active and passive control groups over a 8-week period, and at     3-month follow-up. Study Aim 2: To compare the psychiatric benefit of 24 training sessions of     Captain's Log CCRT to the active and passive control groups over an 8-week period, and at     3-month follow-up. Study Aim 3: To evaluate how HIV subtype, ART treatment status, and the     corresponding clinical stability of the child modifies CCRT neuropsychological performance     gains and psychiatric symptom reduction. Outcome Assessments: The Kaufman Assessment Battery     for Children, 2nd ed. (KABC-2), Tests of Variables of Attention (TOVA) visual and auditory     tests, CogState computerized neuropsychological screening test, Bruininks-Oseretsky Test of     Motor Proficiency (BOT-2), and Achenbach Child Behavior Checklist (CBCL) will be administered     before and after the 8-week training period and at 3-month follow-up. We have previously used     all these assessments with Ugandan children with HIV to effectively evaluate     neuropsychological and psychiatric problems. Captain's Log has an internal evaluator feature     which will help us monitor the specific training tasks to which the children best respond.     Based on our prior research with Kayunga children with HIV, we anticipate that about 40% of     our sample will be on ART at study enrollment, and about 20% will be Subtype D while 60% will     be subtype A. We also observed that children with HIV Subtype A are at greater risk for     neurocognitive deficits. Analyses: We will compare neuropsychological and psychiatric gains     over the 8-week training period and at 3-mo follow-up for our three study groups,     anticipating that they will be significantly greater for the CCRT intervention children     (Study Aims 1 & 2). These neuropsychological gains will be associated with improved school     performance over the long-term. Intervention children on ART will have greater gains than     those not on ART, and HIV subtype D children will have lower viral loads and higher     lymphocyte activation levels, resulting in greater gains from CCRT (Study Aim 3). Conclusion:     CCRT will prove effective and sustainable in potentiating the neurocognitive benefit of ART     in HIV children. It will prove viable for assessing and treating children in resource-poor     settings.   "
235177|NCT00926016|"     The purpose of this study is to determine if rosiglitazone, a medicine used to treat     diabetes, improves response to anti-viral treatment.   "
235178|NCT00926029|"     Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival     inflammation.   "
235179|NCT00926042|"     Registry program for volunteers who are willing to serve as control subjects in future     research studies.   "
235180|NCT00926055|"     18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for     identifying and quantifying vascular inflammation within atherosclerotic plaques. Therefore,     in this study the investigators intend to compare the effect of ezetimibe monotherapy or     ezetimibe plus statin combination therapy on the atherosclerosis regression using FDG-PET.   "
235181|NCT00926068|"     A prospective, double blind, randomized, placebo controlled, outpatient, parallel group     comparison trial to assess the safety and efficacy of HO/03/03 10µg versus Placebo, applied     topically once daily for up to 14 weeks in at least 196 subjects diagnosed with Diabetes     Mellitus and having a single target non-healing Plantar Neuropathic Diabetic Foot Ulcer.   "
235182|NCT00926081|"     The aim of the investigators' study is to analyze the value of supervised exercise training     combined with medical therapy versus best medical treatment only with respect to quality of     life. Furthermore, the investigators aim to evaluate the effect of supervised exercise     training on microcirculation, peripheral endothelial progenitor cells as well as on future     major cardiovascular adverse events.   "
235183|NCT00926094|"     Idiopathic Adhesive Capsulitis, Frozen Shoulder is a condition in which there is a limitation     and significant pain at the shoulder and it is increases with shoulder movements. The causes     are not clear. The prevalence of this condition is four times higher in diabetic patient     compare to the general population.      The relation between frozen shoulder and impaired glucose tolerance remain unclear.      Our hypothesis is that patients with no diabetes and that suffer from frozen shoulder have a     higher prevalence of impaired glucose tolerance than the general population age matched.   "
235184|NCT00926107|"     The primary objective of this study is to determine the efficacy of Temsirolimus in patients     with ovarian cancer with CA125 only relapse after first-line platinum-based chemotherapy.   "
235185|NCT00926120|"     The purpose of this study is to determine if administering Mogroside Sweetener PureLo (the     study substance) for 14 days will lower the hepatitis C viral load and liver function alanine     aminotransferase (ALT) levels.   "
235186|NCT00926133|"     The present study was designed to determine the prevalence of previously unknown impaired     glucose tolerance and type 2 diabetes in patients with acute ST-elevation myocardial     infarction subjected to acute PCI. Secondary, a possible association between inflammation,     haemostasis and abnormal glucose regulation was studied.   "
235265|NCT00936286|"     The purpose of this study is to determine whether respiratory muscle training by means of     normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with     mild to intermediate sleep apnea syndrome.   "
235187|NCT00926146|"     In this study, researchers from UCLA and Friends Community Center will work together in     designing a program to assist young homeless stimulant-using gay and bisexual homeless men to     complete the hepatitis vaccine and in reducing drug and sexual activity. Using nurse case     management strategies, found successful with homeless adults as well as contingency     management strategies, found successful with gay and bisexual homeless adults by the     community partners, the investigators will evaluate the effectiveness of a program that     combines both strategies. As stimulant use threatens to increase homeless persons' risk of     exposure to hepatitis A and B viruses, particularly among young users who may not yet be     HBV-infected, this research is targeted to engage this group in treatment, until they are     suitably protected from HBV, and hopefully reduce risk for HCV and HIV as well.   "
235188|NCT00926159|"     Prophylactic implant of an ICD (implantable cardioverter defibrillator) for prevention of     sudden cardiac death from a life-threatening heart rhythm abnormality is a standard     recommendation for patients with ejection fractions (EFs) of 35% or less. The main purpose of     the trial is to determine why patients who are receiving care at a community-based cardiology     program and are known to have a low ejection fraction (EF) measurement of 35% or less per     echocardiogram and/or cardiac nuclear scan testing are not being approached for ICD     (implantable cardioverter defibrillator) implant. Additionally, other secondary purposes of     the trial are: 1) to determine if these patients are or are not receiving recommendation from     their provider to undergo prophylactic ICD implant 2) identify the reasons providers are not     recommending ICD implant for their patients with reduced EFs 3) determine reasons patients     recommended for ICD implant by their provider elect not to have the implant.   "
235189|NCT00931866|"     The primary purpose of this study is to assess the effectiveness of once daily application of     a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when     applied to the painful area.   "
235190|NCT00931879|"     The objective of this study is to determine the efficacy of 6 months of 4 g/day oral Lovaza®     on endothelial-dependent and heat-induced vasodilation in type 2 diabetics with neuropathy     and elevated triglyceride levels. Omega-3 fatty acids appear to exert beneficial effects on     vascular function that are independent of the changes in serum triglycerides. The efficacy     will be compared with a placebo given at the same duration. Efficacy of the drug will be     evaluated after 3 and 6 months of treatment. This timeline should be adequate for evaluation     of the primary neurophysiological endpoints. Previously, the investigators have demonstrated     that it is feasible to pharmacologically alter nerve fiber density in as little as 18 weeks     and that this correlates with subjective and objective measures of neurovascular function.     The investigators are predicting an enhancement of post-ischemic hyperemia of the foot     dorsum, where the dilative mechanism is primarily endothelium-dependent and a similar     improvement in heat-induced hyperemia.   "
235191|NCT00931892|"     1. The purpose of this research study is to evaluate non-invasive markers of celiac disease          activity in subjects that are on a gluten-free diet, in remission from celiac disease          who undergo gluten challenge.        2. The secondary aims of this protocol are to identify novel mediators important in the          pathophysiology of celiac disease and to evaluate changes in metabolism with gluten          exposure.   "
235192|NCT00931905|"     Saturnism, or lead poisoning, is defined by clinical symptoms (affecting primarily the     nervous, hematopoietic, gastrointestinal, cardiovascular, musculoskeletal, renal and     reproductive systems) compatible with exposure, in the short or long term, to lead or to its     compounds, and can manifest as acute or chronic symptoms, pursuant to the intensity and     duration of the signs and symptoms. Measuring serum concentration is the primary method for     diagnosing and accompanying exposed workers. Presently, elevated lead counts are reversed by     using drugs whose effectiveness is contested on various fronts. Experimental studies shows     the efficacy of homeopathic preparations in controlling blood lead levels in laboratory     animals, creating the need for controlled studies that evaluate the effectiveness and safety     of these preparations in humans.The objective of this study was evaluate the effectiveness of     the homeopathic preparation Plumbum metallicum in reducing the blood lead level of workers     exposed to this metal.   "
235193|NCT00931918|"     This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without     VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse     Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to     RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.   "
235194|NCT00931931|"     Patients with relapsed solid tumors such as sarcomas and neuroblastoma have a poor survival,     generally < 20%. There is an urgent need for new treatments that are safe and effective.      HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the     RL1 gene which encodes the protein ICP34.5, a specific determinant of virulence. Mutants     lacking the RL1 gene are capable of replication in actively dividing cells but not in     terminally differentiated cells - a phenotype exploited to selectively kill tumor cells. In     previous clinical studies, HSV1716 has been shown to be safe when injected at doses up to     10^5 plaque forming units (pfu) directly into human high-grade glioma and into normal brain     adjacent to tumour, following excision of high-grade glioma. In an extension study, HSV1716     has been shown to be safe when injected at a dose of up to 10^6 pfu directly into brain     tumours. Replication of HSV1716 in human glioblastoma in situ has been demonstrated.     Following a single administration of HSV1716 by direct injection into active recurrent tumor     or brain adjacent to tumor, some patients have lived longer than might have been expected.     This study seeks to evaluate the safety of a single injection of HSV1716 in the treatment of     extracranial solid tumors in adolescents and young adults.      HSV1716 has also proved safe when given by direct intra-tumoural injection in patients with     squamous carcinoma of the head and neck, and in patients with malignant melanoma.      Replication of HSV mutants in human sarcomas and neuroblastoma in cultured cells and human     xenograft models has been demonstrated.      This study is designed in two parts. PART 1 of the study specifies a single dose of virus.     Participants who experience at least stable disease or relapse following a determination of     stable disease, may qualify for subsequent doses in PART 2. PART 2 requires signing of a     separate consent.      Funding Source - FDA OOPD   "
235195|NCT00931944|"     This is an open-label, multi-center study designed to extend the evaluation of the safety,     tolerability, and clinical effects of oral administration of KNS-760704 in patients with ALS.   "
235196|NCT00931957|"     The purpose of this study is to find if Etanercept can improve the outcome of ocular lesions     of Behcet's Disease treated with Methotrexate and Prednisolone   "
235197|NCT00931970|"     The purpose of this study is:      1. to compare complications and mortality of hemodialysis with those of peritoneal dialysis     in Korean end stage renal disease (ESRD) patients; 2. to analyze the treatment effects on     quality of life (QOL) by dialysis modality; and 3. to analyze cost-effectiveness by dialysis     modality.   "
235202|NCT00932035|"     This pilot phase I and randomized phase II trial studies the best way to perform axillary     lymph node preservation surgery and to see how well it works in preventing lymphedema in     patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast     cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary     lymph node dissection is more effective than standard axillary lymph node dissection in     preventing lymphedema.   "
235294|NCT00936663|"     This study is designed to see if the use of the drug Sitagliptin (used to reduce insulin     resistance) will delay or prevent kidney transplant patients from getting diabetes.   "
235701|NCT00933881|"     This study is designed to evaluate the amount of heart rate variability (HRV) for women with     gestational diabetes mellitus (GDM) and to determine whether women with GDM have transient     sleep-disordered breathing (SDB) during pregnancy.   "
235204|NCT00932061|"     The hypothesis of this study is that biological markers are present in the body that are good     indicators of chronic pain. Eligible participants will be assessed at baseline and after     receiving a series of acupuncture or sham acupuncture (something that resembles, but is     not, active acupuncture) sessions. If the subject qualifies for the investigators' research     and are subsequently enrolled in this study, they will be randomly assigned (like the flip of     a coin) to one of these two groups. Acupuncture, as previously shown by this group, leads to     improvements in both clinical and evoked pain associated with fibromyalgia. The study     involves two magnetic resonance imaging (MRI) brain scans, one at the beginning and one at     the end of the study. Another optional portion of the study would involve 2 PET (positron     emission tomography) scans of the subject's brain, one at the beginning and one at the end of     the study; this type of scan allows us to get more specific information about the subject's     brain function during an acupuncture session.   "
235205|NCT00932074|"     The purpose of this study is to assess the safety, tolerability and efficacy of KP‑413     topical ointment compared with vehicle ointment in treating adult subjects with atopic     dermatitis (AD).   "
235206|NCT00932087|"     Case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12     metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls   "
235207|NCT00932100|"     The purpose of this study is to evaluate the safety and efficacy of the REG1 anticoagulation     System in Acute Coronary Syndrome (ACS) patients undergoing cardiac catheterization.   "
235208|NCT00932113|"     The objective of this study is to compare the mechanism of action between adalimumab and     methotrexate in subjects with psoriasis.   "
235209|NCT00932126|"     This is the first study using PF-03758309, an oral compound, in patients with advanced solid     tumors. In this study different doses of PF-03758309 will be administered to different groups     of patients. The study will assess the compound's safety, the blood levels of PF-03758309     during the treatment and the effect of the compound on the tumor cells.   "
235210|NCT00932139|"     Based on previous published research in animals, the investigators hypothesize that     electroacupuncture (EA) will have a positive effect on hypertension.   "
235211|NCT00932152|"     This research study will test whether dual anti-estrogen therapy (anastrozole and     fulvestrant) slows the time to when the cancer progresses.   "
235212|NCT00932165|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
235213|NCT00932178|"     Calmer Life is a research study for older adults with anxiety. In the program participants     will have the opportunity to learn skills that may help cope with anxiety. Participants have     the option of including religion and spirituality into the skill. Skills participants can     learn include: how to relax, how to change the way you think about things, and how to solve     problems more effectively.   "
235214|NCT00932191|"     The purpose of this study is to compare two cataract surgical technique variations for     removing the nucleus of the lens (central part of the lens) in terms of damage to the inner     layer of the cornea which is called the endothelium. One variation uses more ultrasound     energy and the other more mechanical force to break up the nucleus.   "
235215|NCT00935623|"     The purpose of this study is to demonstrate that volunteers can be safely and reproducibly     infected with Plasmodium vivax (P. vivax) by the bites of experimentally infected Anopheles     dirus (An. dirus) mosquitoes carrying P. vivax sporozoites in their salivary glands.   "
235216|NCT00935636|"     The purpose of this study is to collect relevant airway data using the GlideScope Cobalt     Video Baton 1 and 2 for intubation in a large cohort of neonates and infants weighing 10 kg     or less.   "
235217|NCT00935649|"     To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected     toenails.   "
235218|NCT00935662|"     The primary objective for this study is to assess the safety and tolerability of AZD8329 when     given as a single dose in increasing dose strength, and also to identify the highest     tolerated dose for future studies.   "
235219|NCT00935675|"     Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months in     patients with head and neck squamous cell carcinomas (oral cavity, larynx, oropharynx and     hypopharynx) and with an HADS total score > 11   "
235220|NCT00935688|"     In areas of which are co-endemic for vivax and falciparum malaria, treatments for the two     diseases often differ and this may lead to mistreatment. This places an emphasis on diagnosis     at the health service provision level. Diagnosis is also important when malaris endemicity is     low - most fevers are not caused by disease. These two issues mean that most malaria and     fevers are not adequately treated, even though the drugs may be effective; many patients who     do not have malaria are treated for the disease, and patients with malaria may get the wrong     treatment for their species. The study aims to test the effectiveness of employing rapid     diagnostic tests and will study the effect on correct treatment.   "
235274|NCT00936403|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     safety, tolerability, pharmacokinetics (the determination of the concentration of the     administered medication in blood over time) and pharmacodynamics (the determination of the     effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in     growth hormone deficient children.   "
235236|NCT00935896|"     Objective: To compare the effects of a protective versus a conventional ventilatory strategy,     on systemic and in lung production of tumor necrosis factor-alpha (TNF-alpha) and     interleukin-8 (IL-8) in patients without lung disease.      Hypothesis: High tidal volumes induce inflammation in patients without lung disease Design:     Prospective control-randomized study. Patients and Setting: Twenty patients without lung     disease and submitted to mechanical ventilation admitted to one trauma and one general adult     intensive care unit of two different university hospitals.      Interventions: Patients were randomized to receive mechanical ventilation either with tidal     volume (VT) of 10-12 ml/kg predicted body weight (high VT group) or with VT of 5-7 ml/kg     predicted body weight (low VT group) with an O2 inspiratory fraction (FIO2) enough to keep     arterial oxygen saturation > 90% with positive end-expiratory pressure (PEEP) of 5 cmH2O     during 12 hours after admission to the study.   "
235221|NCT00935701|"     The purpose of this study is to see if children with autism spectrum disorder (ASD) will     tolerate an acupressure and acupuncture intervention twice weekly over a 3 month period of     time that targets regulatory and behavioral functions. It is anticipated that: 1) children     with ASD will tolerate acupressure and, when properly prepared, acupuncture; 2) parents and     children will attend bi-weekly appointments over a 3 month period; 3) parents will find     administered acupressure technique beneficial to their child and the parent/child     relationship; 4) parents will report lower levels of stress regarding their parenting     experience. In addition, we will learn information about specific child regulatory and     behavior functions (including sleep and attention) from parent and teacher reports while the     child receives acupressure and/or acupuncture. A small clinical trial will be conducted with     50 eligible children (3-10 years of age) with ASD (and one parent each) who will be enrolled     into two groups: Phase 1 pre-pilot group of 10 children who will complete 8 weeks of     treatment to help develop a treatment protocol; Phase 2 with 40 children treated for 12     weeks. Parents and teachers will complete pre-intern and post surveys, and children who do     not tolerate acupressure/acupuncture will be counted as treatment failures for analyses.   "
235222|NCT00935714|"     Arm exercise influences arm volume and symptoms in breast cancer related lymphedema.   "
235223|NCT00935727|"     The study was developed to acquire images of normal, then abnormal, then unknown diagnosis     for transplanted kidneys in order to determine whether the elastography imaging modality, a     type of ultrasound imaging, can provide data useful for diagnosis of renal transplant     abnormalities.      The specific aims of this study are:        1. To define normal elastography imaging by correlation with clinical findings.        2. To define specific abnormal elastography images by correlation with clinical findings.        3. To determine whether elastography could be useful in early diagnosis of abnormalities of          renal transplants, especially in early rejection.   "
235224|NCT00935740|"     Monocyte tissue factor (TF) was characterized in Class C heart failure (HF) vs. 25     age-matched volunteers. TF was 2.9 fold higher (p < 0.001) in HF patients vs. controls. HF     patients showed increased clinical events (RR=1.29, p=0.04) when comparing procoagulant     activity above/below median. HF is associated with increased TF expression.   "
235225|NCT00935753|"     To assess the possibility that treatment with Kuvan (a form of tetrahydrobiopterin) will     lessen the abnormal behavior and/or neurology commonly found in Lesch-Nyhan disease (LND); to     assess biochemical changes as measured in blood and urine.   "
235226|NCT00935766|"     The overall objective of LUCHAR Specific Aims 4.1 and 4.2 is to assess the additional     contribution of cardiovascular disease (CVD) risk markers to traditional biomedical risk     factors in the prediction of pre-clinical CVD. Specific Aim 4.3 will test the impact of     omega-3 fatty acid supplementation on risk markers and pre-clinical markers of CVD in     Hispanic patients.      Specific Aim 4.3: Conduct a randomized, placebo-controlled trial of the effect of omega-3     fatty acid supplementation on vascular function as measured by brachial artery reactivity     (BAR) and on circulating inflammatory markers.      Hypotheses:        1. Daily omega-3 fatty acid supplementation will improve vascular function in subjects at          high risk for CVD.        2. Daily omega-3 fatty acid supplementation will reduce inflammatory protein panel scores          in subjects at high risk for CVD.   "
235227|NCT00935779|"     Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma.     Involved mechanisms are poorly understood though experimentally it has been demonstrated that     neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of     damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic     microscopy in control subjects and in patients with early or locally advanced gastric cancer     looking for spontaneous changes in peritoneal surface not related with surgical injury.   "
235228|NCT00935792|"     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the signaling     molecules needed for cell growth. Monoclonal antibodies, such as alemtuzumab, can bind to and     kill malignant lymphocytes.      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when     given together with alemtuzumab and will see how well they work in treating patients with     recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL).   "
235229|NCT00935805|"     The aim of this study is to to analyze if it is possible to reach the goals of HbA1c <7.0%     and blood pressure <= 130/80 mm Hg in a cohort of patients with type 2 diabetes attending a     primary care unit, using ony those resources available at the unit, and provided by the     Brazilian National Health System. It is an open label, observational study, with a duration     of 4-6 years. Patients attending a primary care outpatient facility will be sequentially     included in the study provided they give consent. They will be followed on a monthly basis by     a team of physicians and nurses. Glucose, A1c, Blood PRessure will be the outcomes.   "
235230|NCT00935818|"     This study provides an opportunity to combine varenicline and bupropion SR and capitalize on     the potential additive benefit. The investigators hypothesize that this will further increase     long-term (≥ 6 months) smoking abstinence rates.   "
235231|NCT00935831|"     The purpose of this study is to characterize the safety and tolerability of single doses of     compound 1278863A in subjects with renal impairment.   "
235232|NCT00935844|"     This study is being conducted to evaluate the safety profile and the Maximum Tolerated Dose     (MTD) of TAK-901 in adult patients with advanced solid tumors or lymphoma. This study will     help to identify the recommended phase 2 dose and infusion duration, and describe the     pharmacokinetics of TAK-901.   "
235233|NCT00935857|"     Patients with a prior incomplete colonoscopy will be enrolled in this study. Patients will be     randomized to either an initial repeat attempt with a standard colonoscope or the single     balloon enteroscope. If the procedures is unsuccessful, the patient can be crossed-over to     the other group. The primary endpoint of the study is a complete colonoscopy.   "
235234|NCT00935870|"     The main aim is to evaluate the long-term safety and bone healing in the operated area and to     compare bioactive glass granules with autogenous bone as a filler material.   "
235235|NCT00935883|"     To evaluate the safety and efficacy of eculizumab for the treatment of dry AMD as evaluated     by the change in drusen volume and area of geographic atrophy.   "
235435|NCT00938197|"     To evaluate the pharmacokinetic drug interaction after oral concurrent administration of     fimasartan and amlodipine in healthy male volunteers   "
235238|NCT00935922|"     The aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma     inflammatory markers, and insulin sensitivity.      We hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease     triglyceride, total and LDL-cholesterol and increase HDL-cholesterol).      Flaxseed is the richest dietary source of lignan secoisolariciresinol diglucoside (SDG).     Lignans are estrogens found in plant sources that behave similar to endogenous estrogens and     have been associated with cardiovascular benefits due to their antioxidant activity.     Therefore, we also hypothesize that flax-lignans will cause a significant decrease in LDL     oxidation and in inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6),     IL-1B, serum fatty acid binding protein 4 (FABP-4), and serum amyloid attached to high     density lipoprotein (HDL-SAA).   "
235239|NCT00935935|"     This study will look to see if there are changes in the blood cells that are associated with     bone disease and sort out effects that are due to the HIV virus itself, the medications and     see if faster aging occurs in the cells of HIV infected persons. Bone disease will be     measured by a special X-ray called a DEXA scan. A DEXA scan is used by doctors to see if     someone has normal bone mass for their age or if there is thinning of the bones.      The purposes of this study are:        -  to learn how common bone disease is in HIV infected patients over the age of 50 years          that receive their care at the CORE Center        -  to see what are the common causes of bone disease in older HIV infected persons        -  to see if there are differences in blood cells and levels of cytokines in patients who          do or do not have bone disease, as this may help researchers determine the cause of bone          disease.   "
235240|NCT00935948|"     The aim of our study was to assess the clinical efficacy and safety of the drug Imescard     compound water smartweed, adrenalin and hamamelis ointment in the treatment of hemorrhoidal     disease in adults, in a randomized, double-blind, placebo-controlled clinical trial.   "
235241|NCT00935961|"     The purpose of this study is to test the safety of RAD001 (everolimus) tablets at different     dose levels, when added to docetaxel and cisplatin. The investigators want to find out what     effects, good and/or bad, that everolimus has when added to docetaxel and cisplatin as     treatment for head and neck cancer.   "
235242|NCT00935987|"     This study seeks to (i) determine a safe and tolerated dose of CYT387 given to patients with     PMF, post-PV or post-ET and, (ii) assess the effectiveness of orally-administered CYT387 as a     treatment for PMF, post-PV or post-ET.   "
235243|NCT00936000|"     Alcohol is one of the most commonly abused drugs in the world. Up to 40% of medical and     surgical patients have alcohol related problems, and alcohol use accounts for more than 10%     of U.S. health care costs. In the intensive care unit (ICU), patients with a history of     alcohol abuse are common where their rates of mortality and ICU-related morbidity are     significantly higher when compared to patients without a history of alcohol abuse. Though ICU     patients are a heterogeneous group, Acute Respiratory Distress Syndrome (ARDS), a devastating     form of acute lung injury, is one of the more frequent diagnoses among these critically ill     patients.      In 1996, we made the novel observation that a prior history of chronic alcohol abuse is     associated with an increased incidence and severity of ARDS in critically ill patients. In     our epidemiological studies of over 570 critically ill patients, 50% of all patients with     ARDS have a significant history of chronic alcohol abuse. Since ARDS affects approximately     150,000 patients per year in the United States, and mortality is 40-50% even in previously     healthy individuals, alcohol-related ARDS is an enormous national health care problem. We     estimate that between 15,000 and 25,000 deaths per year in the United States are associated     with alcohol-related ARDS, a number consistent with or even exceeding the number of deaths     due to many other alcohol-related diseases such as cirrhosis of the liver and alcohol-related     traffic accidents. Further investigations of the association between chronic alcohol abuse     and ARDS are needed to develop therapies that improve morbidity and mortality in this     important patient population.      The clinical syndrome of ARDS is defined as refractory hypoxemia with bilateral infiltrates     on chest radiograph in the absence of left atrial hypertension. Pathophysiologically, ARDS is     characterized by diffuse alveolar damage, increased pulmonary alveolar-capillary     permeability, and the subsequent accumulation of extravascular lung water. In animal models     of chronic alcohol abuse, we showed that chronic ethanol ingestion causes chronic oxidative     stress, depletes lung glutathione, impairs alveolar-capillary barrier function, and     exaggerates endotoxin-mediated acute lung injury. Ethanol-mediated disruption of the     alveolar-capillary barrier, and the associated susceptibility to acute edematous injury, is     modified by glutathione (GSH) replacement therapy in animal models.      Responding to NIH emphasis on studies of the mechanisms of disease and evaluation of     therapies in human subjects, our group has initiated translational studies that expand our     basic observations of the effects of chronic alcohol abuse on ARDS to the clinical setting.     We recently reported that lung epithelial lining fluid from individuals with a prior history     of chronic alcohol abuse is deficient in GSH, an essential antioxidant. The translational     experiments outlined in this proposal will identify alterations in the structure and function     of the lung in individuals with a history of chronic alcohol abuse and test a novel medical     therapy that may ultimately decrease the morbidity and mortality for 50,000-75,000 ARDS     patients with a prior history of chronic alcohol abuse per year in the United States.      We propose the following hypothesis that antioxidant deficiency is a cause of abnormal     alveolar-capillary barrier function in individuals with a history of chronic alcohol abuse,     and oral anti-oxidant replacement therapy will correct the abnormality.      If this hypothesis can be confirmed, this work would pave the way for testing antioxidant     replacement as prophylaxis against acute lung injury in alcoholic patients at risk for the     development of ARDS.      Specific Aim: To determine the safety and efficacy of in vivo antioxidant replacement therapy     on alveolar-capillary barrier function in individuals with a history of chronic alcohol     abuse.   "
235244|NCT00936013|"     The purpose of the study is to determine whether the combination treatment of Chinese     medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel     influenza A (H1N1) pneumonia.   "
235245|NCT00936026|"     Primary:      To assess the effects of CYP2B6 inhibition by repeated dose Clopidogrel (75 mg/day)     co-administration on the single-dose pharmacokinetics of Neramexane      Secondary:      To assess safety and tolerability of Neramexane single dose treatment alone and     co-administration of a Neramexane single-dose with a Clopidogrel repeated dose treatment   "
235246|NCT00936039|"     In the present study, the effects of 3 weeks of unloading on muscle mass and muscle fiber     characteristics will be determined. In addition, the effects of 6 weeks of recovery will be     assessed.   "
235247|NCT00936052|"     Standard treatment for glioblastomas includes radiation and chemotherapy with a drug called     temozolomide (Temodar); however, glioblastomas frequently develop resistance to standard     treatment and recur or progress. Glioblastomas are known to have decreased levels of oxygen     compared to normal tissues. There is evidence that these lower oxygen levels in glioblastomas     may contribute to their ability to resist treatment effects of radiation and chemotherapy. In     this study we will look to increase the oxygen concentration within the glioblastoma by     adding hyperbaric treatments (the experimental part of this study) to standard treatment with     radiation and temozolomide in order to see whether increasing the oxygen concentration within     the tumor increases the tumor-killing ability of standard radiation and chemotherapy.      In addition, the investigators are interested to evaluate the effect of this treatment     protocol on a person's quality of life and level of stress, and, therefore, the investigators     will ask subjects to complete several brief questionnaires while they are on-study.   "
235248|NCT00936065|"     To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a     maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice     Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.   "
235249|NCT00936078|"     Living kidney donors and non-donor controls will be studied before and after the living donor     transplant. The donor and non-donor will be followed for up to 5 years. The purpose of this     study is to see if there are any differences between the two groups in regards to blood     pressure, rate of hypertension, kidney function and psychological well being and economical     status.   "
235315|NCT00936936|"     The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy     can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs     gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will     include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug     combinations will also be studied.   "
235250|NCT00936091|"     Intestinal parasitic infections, malnutrition and iron deficiency anaemia (IDA) are still     considered as public health problems in rural Malaysia especially among Orang Asli children.     Despite intermittent control programmes, the prevalence of these problems is still high     suggesting the need of other control and interventions measures. This randomized     double-blind, placebo-controlled trial was carried out among Orang Asli schoolchildren from     Sekolah Kebangsaan Betau in Pos Betau, Pahang (200 km northeast Kuala Lumpur) to investigate     the effects of vitamin A supplementation on intestinal parasitic reinfections, growth, iron     status and educational achievement.      HYPOTHESES        1. Vitamin A supplementation has a negative effect on intestinal parasitic reinfections and          the worm burden of infections among Orang Asli schoolchildren in Pos Betau, Kuala Lipis,          Pahang.        2. Vitamin A supplementation has a positive effect on growth (weight and height) among          Orang Asli schoolchildren.        3. Vitamin A supplementation is effective in improving serum iron status among Orang Asli          schoolchildren.        4. Vitamin A supplementation has a positive effect on cognitive function and educational          achievement among Orang Asli schoolchildren.   "
235251|NCT00936104|"     In the current project we aim to study the oncological process of pancreatic cancer, from a     perspective of the CSC-theory and in particular through the 'side population' (SP)-approach.     The SP seems to be enriched for CSC and doesn't a priori exclude any CSC-subpopulation. After     isolation from pancreatic cancer resection specimens, SP cells will be characterized by     gene-expression profiling based on microarray analysis. We'll identify markers and pathways     (with emphasis for stem cell and cancer -related ones) that are differentially expressed in     SP versus the rest of tumour cells (the 'main population' or MP). In order to assess the     prognostic relevance of the SP, we'll study these genes using the high-throughput Nanostring     technology in about 200 snap-frozen PDAC resection specimens of patients from our prospective     database. Finally, two monoclonal antibodies (mAB) will be tested as novel therapeutic agents     in vivo (mouse model), wherein the choice of mAB will be based on prognostically relevant     molecular targets and pathways obtained from the Nanostring results.   "
235252|NCT00936117|"     The goal of this clinical research study is to learn the amount of posaconazole that is in     the body at different time points when given to patients with leukemia. The safety of this     drug will also be studied.      Objectives:      Primary:      To study the plasma pharmacokinetics of posaconazole in patients with newly diagnosed acute     myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) undergoing     induction chemotherapy or relapsed or refractory patients who will receive salvage     chemotherapy.      Secondary:      To evaluate the safety of posaconazole given as prophylaxis.   "
235253|NCT00936130|"     The purpose of the study is to determine the effect of three weight loss surgeries compared     to a low calorie diet with regard to energy expenditure, body composition, insulin     sensitivity, and the response of gastrointestinal peptides to a standard meal. Baseline     assessments will be conducted in all four groups and changes will be compared six and     fifty-two weeks post-operatively.   "
235254|NCT00936143|"     This is a prospective open-label study to evaluated the efficacy and safety of     infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS).     Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th     week, with dosing of 5mg/kg. The major outcome index is ASAS20, and minor outcome indexes     include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. And MRI of sacroiliac joint is not     necessary. The adverse events at any time were recorded.   "
235255|NCT00936156|"     Primary objective : To increase the 3 year progression-free survival from 40% to 60%.     Patients included : metastatic, cerebral primitive neuroectodermal tumors in children aged     over 5 years.   "
235256|NCT00936169|"     The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS)     optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions   "
235257|NCT00936182|"     Antifungal therapy is widely used for individuals with Autism Spectrum Disorders (ASD). The     current investigation will examine the effects of fluconazole on behavioral functioning among     children with ASD. This is a double-blind, randomized, placebo-controlled study of oral     fluconazole in children who meet criteria for ASD. Pre- and post-treatment behavioral ratings     will be used to evaluate the efficacy of fluconazole therapy. In addition, children will     undergo comprehensive medical history, physical examination, and laboratory analyses.      Our objective is to quantify differences in behavioral functioning between the fluconazole     treatment and a placebo. Our primary hypothesis is that, on average and relative to the     placebo, children with ASD who receive fluconazole will show greater improvements in symptoms     of autism.   "
235258|NCT00936195|"     To assess the maternal and infant safety of a single daily fixed-dose combination of     TDF/FTC/EFV (Atripla®), compared to the association of LPV/r (Kaletra® or Aluvia®) and     3TC/ZDV (Combivir®) given to African women to prevent overall MTCT in populations practicing     breastfeeding.   "
235259|NCT00936208|"     PRO-POWER is an observational cohort study for a period of 24 weeks. All recruited patients     will have essential hypertension. In addition, the patients will have at least one other     contributing risk factor for cardiovascular events. The study aims to evaluate the safety,     efficacy and protection of Micardis 80mg/Micardis plus 80/12.5mg from cardiovascular risks in     patients with essential hypertension   "
235260|NCT00936221|"     To assess the efficacy in terms of overall survival of AZD6244 in combination with     dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation     positive advanced cutaneous or unknown primary melanoma   "
235261|NCT00936234|"     SDF-1, an important cytokine for neovascularisation is cleaved by (dipeptidyl peptidase IV)     DPPIV.      The aim of this study is to assess the effect of the dipeptidyl peptidase IV inhibitor     vildagliptin (Galvus®) on endothelial function as well as number and functional activity of     progenitor cells in patients with documented diabetes mellitus.   "
235262|NCT00936247|"     This investigational study will investigate two different volume replacement regimes in     patients suffering from compromised renal function.   "
235263|NCT00936260|"     The purpose of this study is to determine the duration of the treatment with alendronate in     postmenopausal women with osteoporosis.   "
235494|NCT00939354|"     This study will investigate the importance of exhaled nitric oxide measurements in subjects     with asthma age 65 and older. This group of patients has been ignored in most previous asthma     studies.   "
235275|NCT00936416|"     Estimation of Glomerular Filtration Rate (GFR) is the primary test used to assess patients     with renal disease. Although serum creatinine based GFR and nuclear medicine based     estimations are routinely used in clinical practice, GFR estimation by Inulin is the     recommended gold standard. Inulin based estimation of GFR is cumbersome and time consuming.      A decrease in blood flow to the kidney (Renal Blood Flow (RBF)) is known to cause a decrease     in GFR. RBF is typically determined using radioactive tracers, contrast MRI or a cumbersome     para-aminohippuric acid (PAH) clearance method.      MRI based assessment of GFR and RBF have been suggested to provide reasonable accuracy. Most     of these studies did not compare the GFR and RBF estimation directly to Inulin and PAH     clearance which are ther gold standards . In this study we propose to estimate MRI based GFR     estimation directly to Inulin and noncontrast MRI based derived RBF to PAH to assess if MRI     is an accurate test of kidney function.   "
235276|NCT00936429|"     This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and     tolerability of HBV-001 D1 in healthy adult subjects.   "
235266|NCT00936299|"     Attention deficit hyperactivity disorder (ADHD) is one of the most common co-occurring     psychiatric disorders (30-50%) in adolescents with substance use disorders (SUD). Yet, little     is known about the safety and efficacy of medications for ADHD in adolescents with SUD, since     such youths have been excluded from most medication trials. Clinicians are therefore     understandably reluctant to treat ADHD in substance abusing adolescents, often first     referring such youths to substance treatment. Untreated ADHD is associated with poorer     substance treatment outcomes. We address this research gap by proposing a randomized     controlled trial of bupropion vs placebo in 130 adolescents (13-19 years) with Diagnostic and     Statistical Manual (DSM IV) ADHD, nicotine dependence and cannabis use disorder (not     excluding other SUD). Participants in both bupropion and placebo treatment groups will     receive weekly individual manualized-standardized cognitive behavioral therapy (CBT)     targeting SUD (at no cost to them) throughout the 16 weeks of the medication trial. Bupropion     also is effective in treating nicotine dependence in adults; the majority of adolescents with     marijuana and other drug abuse also smoke tobacco. More recent research in adults indicates     that bupropion may reduce craving and use of other substances of abuse (e.g. methamphetamine,     cocaine). It's possible impact on cannabis use disorder (the addiction for which most teens     are referred to treatment) has not yet been evaluated. However since all drugs of abuse have     a final common pathway leading to addiction via action in the so called brain reward system     (ventral tegmental area (VTA), accumbens) -an important secondary aim is to evaluate     bupropion's potential impact on craving and use of marijuana (MJ) in addition to its known     similar action on nicotine.   "
235267|NCT00936312|"     This is a multi-center, international study designed to collect clinical, genetic and quality     of life information on females with hemophilia, an inherited bleeding disorder. The study is     designed to determine whether there are problems and issues unique to females with     hemophilia.   "
235268|NCT00936325|"     Background:        -  Systemic Capillary Leak Syndrome (SCLS) is a disorder of unknown cause characterized by          episodes of life-threatening drop in blood pressure and leakage of fluids into tissues.          The outcome from an episode of SCLS may be mild and resolve on its own, or may be severe          and result in death. Although SCLS likely involves abnormalities in the cells lining          blood vessels, the specific cause(s) of this disorder are not known.        -  The treatment of choice for an acute SCLS episode is intravenous fluids and drugs such          as norepinephrine (adrenaline), which are given to keep blood pressure at a level that          will maintain vital organ function. This may be followed by a course of intravenous          steroids and IVIG. Currently, there is no cure, but IVIG has been effective in          diminishing the frequency and/or intensity of SCLS episodes when given regularly, as          long-term effective preventive therapy for many patients who experience recurrent          episodes of SCLS.        -  This protocol is focused on understanding what causes SCLS with the hope that research          findings will lead to the design of safe and more effective treatments.      Objectives:      - To investigate mechanisms that may cause Systemic Capillary Leak Syndrome.      Eligibility:        -  Patients between 16 and older who have been diagnosed with SCLS. Patients who have been          diagnosed with SCLS and are between the ages of 7 and 16 may participate off-site, by          sending specimens to the NIH. Patients 16 and older who have been diagnosed with SCLS          and cannot travel to the NIH may also participate off-site.        -  Patients must have a documented history of at least one episode of SCLS with all three          of the following documented on at least one occasion: low blood volume, low blood          pressure without cause, and evidence of protein leakage during the episode. A letter of          a referral from a treating physician is also required.      Design:        -  Patients seen on site will be evaluated at the National Institutes of Health (NIH) for          approximately 4 to 5 days on an inpatient basis, and will undergo the following          procedures:             -  Medical history and physical examination.             -  Blood samples for evaluation and research purposes, as well as possible genetic               testing.             -  Apheresis procedure, if needed, to obtain a larger volume of blood cells for               research.             -  Bone marrow biopsy, if medically indicated.             -  Other medically indicated tests, such as skin tests to check for possible allergic               reactions.        -  Patients who have a capillary leak episode while at NIH will be treated with the          standard of care for treating SCLS.        -  Patients will be discharged from the protocol 1 year after the NIH visit.        -  Patients participating off-site will be asked to collect and send specimens (such as          blood) to the NIH for research purposes and evaluation.        -  Unaffected Biological relatives of SCLS patients and Unrelated Normal Volunteers may          also enroll on the study. Relatives and Normal Volunteers may be asked to provide          research samples for the study, such as skin biopsy and research blood specimens.   "
235269|NCT00936338|"     The effectiveness of physical therapy for treatment of anterior disc displacement without     reduction of temporomandibular disorders has not been well defined. This study compared the     treatment method with conservative splint therapy. Fifty two subjects were assigned at random     to either of two treatment groups: one is a splint treatment group, and the other is a joint     mobilization self exercise group. Each treatment was evaluated using four outcome variables:     (i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and     (iv) limitation of daily activities. All outcome variables were significantly improved after     eight-week of treatment in the exercise group. Meanwhile, the splint treatment improved three     variables, other than mouth opening with pain; however, the degree of improvement was less     than that seen in the exercise group. This result demonstrates that the joint mobilization     self exercise improves jaw function and relieves pain as compared to the splint treatment.   "
235270|NCT00936351|"     The purpose of this study is to develop a treatment manual for mindfulness meditation to be     taught in a group format to individuals with schizophrenia who are engaged in vocational     rehabilitation. This study will also determine whether mindfulness meditation is beneficial     in terms of improving work function by reducing distressing emotional states and thinking     patterns.   "
235271|NCT00936364|"     This partially randomized clinical trial studies short-term fasting in reducing side effects     in patients receiving gemcitabine hydrochloride and cisplatin for advanced solid tumors.     Short-term fasting before chemotherapy may reduce the side effects caused by chemotherapy.     Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing.   "
235272|NCT00936377|"     This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol     withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive     dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while     maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a     dose-dependent profile of action when it is used for this indication. In addition, this study     will assess the relationships between alcohol withdrawal, therapy with dexmedetomidine, and     potential serum biomarkers of alcohol withdrawal.   "
235273|NCT00936390|"     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill     tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells.     Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not     yet known whether radiation therapy is more effective with or without androgen-deprivation     therapy in treating patients with prostate cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works compared with radiation therapy given together with androgen-deprivation therapy in     treating patients with prostate cancer.   "
235277|NCT00936442|"     ARTEMIS is a study to assess how educational material affects overall adherence to     anastrozole by evaluation of patients' electronically compiled dosing histories. Patients'     dosing times are compiled electronically using Medication Event Monitoring System (MEMS®) in     order to be able to gather accurate, objective and up-to-date patients' dosing histories. For     subjects in Group A, the control group, the adherence to anastrozole in the standard clinical     practice will be evaluated. For subjects in Group B, on top of the standard clinical     practice, they will also receive educational material by mail at week 0 (study registration),     week 2, week 4, week 6, week 8, week 12, month 5, month 7, and at month 10. This procedure is     the same as in the ongoing CARIATIDE study. One of the reasons of poor adherence (either     early discontinuation of the treatment or missing doses while still engaged to the therapy)     can be some side effects experienced by the patients during the anastrozole treatment.     Recording the reasons at discontinuation allows us to identify reasons for treatment     discontinuation. Recording reasons of anastrozole interruptions during the study period     allows us to relate these events to patients' adherence to anastrozole. During the study, no     pro-active safety data collection will take place. Spontaneous reported adverse drug     reactions (ADRs) will be reported according to local post-marketing pharmacovigilance     regulations.   "
235278|NCT00936455|"     SPECIFIC AIM: The specific aims of this study are to evaluate the long term outcomes of     patients previously enrolled in the STRokE DOC (STRokE DOC Trial (NCT00283868))     telemedicine clinical trial.      AIM 1: Aim 1 is a non- randomized, retrospective, data collection study assessing long term     patient outcomes of patients previously enrolled in a telemedicine vs. telephone clinical     trial (STRokE DOC Trial (STRokE DOC Trial (NCT00283868)); now completed). STRokE DOC-LTO     will evaluate, (only for those patients previously enrolled in the original telemedicine vs.     telephone clinical research trial), the long term patient outcomes; comparing telemedicine     versus telephone-only consultations.   "
235279|NCT00936468|"     This study is designed to determine the optimal dose of JVRS-100 and assess safety,     tolerability and immunogenicity of Fluzone® vaccine administered with JVRS-100 adjuvant at     one of three dose levels compared to Fluzone® vaccine administered alone, in 472 adults aged     ≥65 years.   "
235280|NCT00936481|"     Obstructive sleep apnea is a condition in which people have decreased breathing during their     sleep. Untreated sleep apnea has been linked to increased risk for cardiovascular diseases.      This research study is looking at blood clotting factors and blood vessel function in health     volunteers and patients with newly diagnosed or untreated obstructive sleep apnea to better     understand the underlying mechanisms for increased cardiovascular risk.   "
235281|NCT00936494|"     This study will examine whether treatment of inferior turbinates in patients with continued     symptoms of obstructive sleep apnea, sleep related breathing disorder, snoring, disturbed     sleeping, open mouth breathing, and upper airway resistance syndrome after tonsillectomy and     adenoidectomy will improve these symptoms and should be included in the treatment paradigm     for treatment of sleep related breathing disorders in infants, children, and adolescents.   "
235282|NCT00936507|"     The purpose of this randomized controlled study using a crossover design is to investigate     the main effect of portion size and food type (low-energy dense vs. high-energy dense) on     caloric intake.   "
235283|NCT00936520|"     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of     SAR 1118 within the anterior and posterior chamber of the eye and plasma in subjects     undergoing elective vitrectomy when treated with escalating concentrations of the study drug     for approximately 1 week.   "
235284|NCT00936533|"     This study evaluates the clinical effect of foot injection of the bacteria protein Botulinum     toxin A on plantar pain in patients with EBS (epidermolysis bullosa simplex) or PC     (pachyonychia congenita).   "
235285|NCT00936546|"     This study will evaluate the safety and efficacy of the combination of rituximab and     methotrexate to treat disabling fibrosing skin disorders.Rituximab will be administered at     baseline and month 6. The drug will be considered efficacious if the skin thickness     diminishes substantially.   "
235286|NCT00936559|"     Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full     thickness Rotator Cuff Tears (RCTs).   "
235287|NCT00936572|"     Design: double blind controlled randomized trial with a parallel design and 3 treatment     groups Description of subjects: Patients admitted in study centers for colorectal surgery     under laporoscopy and/or laparotomy.      Product:      Product 1: BB536 and LA1 (10E9) Product 2: BB536 and LA1 (10E7) Placebo: Maltodextrin Number     of patients: enrolled subjects: n=33, ITT data set: n=31, PP data set: n=30      Primary objective:      Colonization (biopsy+stools) of each bacteria for one of the dose at D0 (surgical procedure)      Secondary objectives:        -  Influence of the probiotic bacteria on the gut microflora        -  Modulation of the immune and inflammatory response      Additional objectives:        -  Investigate dose effect on La1 colonization        -  Investigate the effect of La1 colonization, treatment without La1 colonization, and          absence of treatment and La1 colonization on other bacteria and on immunological          parameters   "
235316|NCT00936949|"     It has been reported that the operative approaches have an effect on clinical outcome in     total hip arthroplasty. The purpose of this prospective study was to compare clinical and     radiological outcomes between anterolateral approach and posterolateral approach in total hip     arthroplasty.   "
235288|NCT00936585|"     The objective of this NIH-specific substudy is immunologic monitoring of cytokine and immune     cell responses in subjects undergoing treatment with AIN457 (human monoclonal anti-human     interleukin-17A) for moderate to severe Crohn's disease. Recent data suggests that     interleukin-17 (IL-17) is an important mediator of inflammation in certain animal models of     Crohn's disease, and treatment aimed at blocking the IL-23-IL-17 axis can ameliorate the     inflammatory changes. In addition, elevated expression of IL-l7 has been found in the gut     tissue of patients with active Crohn's disease. This substudy will measure changes in     cytokine production, relevant RNA expression, and immune cell populations (in the periphery     and lamina propria) for correlation with clinical outcomes in order to explore the mechanisms     of therapeutic response.   "
235289|NCT00936598|"     This study proposes to test the hypothesis that zolpidem taken the night before major surgery     for endometrial cancer will improve sleep efficiency and reduce post surgery pain, as well as     reduce the need for analgesic medication.   "
235295|NCT00936676|"     Eligible participants, who participated in the ADAGIO trial and who sign an approved informed     consent form, will be enrolled into the study at their original study locations. participants     who have stopped rasagiline therapy and in the opinion of the investigator will gain clinical     benefit from restarting treatment can also be considered for enrollment in the Core follow-up     study period. Use of any other anti-PD treatment is permitted as deemed necessary by the     treating physician (according to the participants clinical status).   "
235296|NCT00936689|"     Background      Hepatic intra-arterial chemoembolization (TACE) is proposed when potentially curative therapy     (eg. surgical resection, percutaneous ablation)is no longer possible. Prospective and     non-randomized retrospective studies showed TACE to be capable to increase survival vs     controls. In 2002 the first results of two RCTs were published which had been conducted on     unresectable HCC patients, designed to assess the impact produced by TACE on survival,     demonstrated a statistically significant advantage in TACE treated patients compared to     controls. The same results have been confirmed by a meta-analysis conducted on 14 trials     published in literature. The limitations of TACE are represented however by the difficulties     in obtaining a complete necrosis of the lesion treated and for this reason new embolization     agents are being developed to increase the efficacy of TACE in HCC as the microsphere, in     poly vinyl alcohol and co-acrylic acid that are not reabsorbable and induce permanent     embolization. The first experimental studies using microsphere showed the good tolerability     and the higher rate of tumor necrosis, but no RCTs have been conducted to investigate their     impact on survival. Objectives. The primary aim of this study is to compare 2 years survival     of patients randomized to selective traditional TACE or selective TACE via microspheres     loaded with Doxorubicin. Secondary objectives investigate the time to progression of disease     (radiologic and symptomatic) by radiologic, laboratory tests and the QoL questionnaire     administration. Methods. This is a multicentre, randomized, open-label, active controlled     study in HCC patients treated with standard TACE vs TACE with doxorubicin - loaded     microsphere. The study comprises a selection period, a treatment period and a follow up phase     with a total duration of 2 years from randomization. Expected results. The sample size(alfa     5%, power 80%) is adequate to detect a 20% difference between TACE with microsphere vs     traditional TACE.   "
235297|NCT00936702|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel     and everolimus works in treating patients with previously untreated cancer of unknown     primary.   "
235298|NCT00936715|"     The objective of this study is to provide open label emtricitabine/tenofovir disoproxil     fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study     GS-US-203-0107.   "
235299|NCT00936728|"     RATIONALE: It is not yet know whether white wine is more effective than a nutritional     supplement in improving appetite.      PURPOSE: This randomized clinical trial is studying white wine to see how well it works     compared with a nutritional supplement in improving appetite in patients with cancer   "
235300|NCT00936741|"     Participants in study C-1073-400 (NCT00569582) will be invited to participate in this     extension study to examine the long term safety of mifepristone in the treatment of the signs     and symptoms of endogenous Cushing's syndrome. Total treatment duration may be up to 12     months or longer at the discretion of the Investigator.   "
235301|NCT00936754|"     The primary endpoint of this trial will be to evaluate the safety of a single administration     in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a     test meal. The secondary endpoint of this trial will be to evaluate if a single     administration in human of a dose of 500 mg of a polyphenol-rich algal powder is able to     reduce the rate of carbohydrate absorption as measured by following postprandial glycemia and     insulinemia.   "
235317|NCT00936962|"     The purpose of the study is to see which of the three current provincial Meningococcal C     Conjugate vaccine schedules in Canada provide the longest lasting protection against     Meningococcal C disease and to see if a booster vaccination is needed.   "
235318|NCT00936975|"     This phase II trial is studying how well fluorine F 18 sodium fluoride positron emission     tomography (PET) works in evaluating response to dasatinib in patients with prostate cancer     and bone metastases. Diagnostic procedures, such as fluorine F 18 sodium fluoride PET, may     help doctors predict a patient's response to treatment and help plan the best treatment.   "
235302|NCT00936767|"     It has now been demonstrated clearly that in Western Cambodia parasitological responses to     artesunate and artemether containing treatment regimens for uncomplicated falciparum malaria     are slower than elsewhere in the world. Median parasite clearance time (PCT) in patients     treated with artesunate 4 mg/kg/day was 78 hours and with 2 mg/kg/day 82 hours, compared to     54 and 48 hours, respectively, in Western Thailand; at 72hours peripheral blood parasitaemia     was still detectable in 55% of patients in Western Cambodia, compared to 7.5% in Western     Thailand. Although occasional poor responses to artesunate have been described previously the     current reports suggest a consistent problem. These antimalarials are central to current     treatment strategies, and so spread of parasites with reduced artemisinin susceptibility     outside this area would be a disaster. A recent consensus meeting Pnomh Penh agreed that this     should indeed be termed resistance, and represented a major threat to malaria control.     Radical containment measures would be needed. This study aims to address whether a     semi-synthetic or fully synthetic peroxide antimalarial would be more effective than     artesunate and could therefore be used in Cambodia as part of the elimination strategy.     Artemisone is a semisynthetic derivative of dihydroartemisinin, which importantly changes its     tertiary structure. This drug has also shown promising efficacy for the treatment of     uncomplicated falciparum malaria in phase II trials in Thailand and seems to be at least as     efficacious as artesunate. No significant toxicity has been reported for artemisone and it is     very well tolerated. If sensitivity for artemisone has remained intact in Western Cambodia,     this will have important implications for the strategies available for containment of the     threatening problem of artesunate resistance in Western Cambodia. It will also have important     implications for further development of these drugs for the use in artemisinin combination     therapies (ACTs).   "
235303|NCT00936780|"     The primary objective of Infinnium-Core™ Registry is to assess the safety and efficacy of the     Infinnium-Core™ Paclitaxel Eluting Coronary Stent System in de novo Coronary Lesions.   "
235353|NCT00937443|"     The incidence of heart failure grows as the population continues to age. Heart failure     incidence approaches 10 per 1,000 persons after the age of 65. Although pharmacotherapy     improves the treatment of heart failure it remains insufficient in preventing the progression     of this debilitating disease. Cell based therapy has gained great strides over the last     decade, launching cellular therapy into the mix of artillery for the treatment of chronic     heart failure and coronary disease. While early pre-clinical work demonstrates that stem cell     based therapy improves heart failure the exact mechanism in which these endothelial     progenitor cells (EPC's) are recruited from the bone marrow, proliferate under the mediation     of growth factors, and migrate to the injured tissues endogenously still remains obscured.     Therefore in order for clinicians and scientist to impact heart failure treatment, a greater     understanding of the physiological changes in EPC's and other modulators of cardioreparative     process need further investigation.   "
235304|NCT00936793|"     Patients with human immunodeficiency virus (HIV) and respiratory disease commonly require     protease inhibitors (PIs) and orally inhaled corticosteroids. Inhaled corticosteroids alone     do not generally cause systemic adverse effects because of low systemic bioavailability, but     the combination of inhaled fluticasone and various PIs has led to increased systemic     fluticasone levels and multiple cases of secondary adrenal insufficiency. A study in healthy     volunteers showed > 350-fold increase in fluticasone area under the curve when ritonavir     (RTV) 100mg twice daily was coadministered with intranasal fluticasone compared to intranasal     fluticasone alone. The mechanism of this drug interaction is presumably secondary to PI     inhibition of cytochrome P450 3A4, the enzyme responsible for fluticasone metabolism. As a     result, inhaled fluticasone is not recommended in combination with most PIs unless the     benefit outweighs the risk. One possible alternative to fluticasone is inhaled     beclomethasone, which has not been studied in combination with PIs. Although beclomethasone     also undergoes metabolism via CYP3A4 in vitro to its more active metabolite,     beclomethasone-17-monopropionate, it appears to be largely hydrolyzed by esterases in vivo.     Furthermore, the pharmacokinetic properties of beclomethasone-17-monopropionate, such as     relatively short half-life, low maximum plasma concentration, and low volume of distribution,     suggest that systemic accumulation leading to significant adverse effects is unlikely even in     the presence of a CYP3A4 inhibitor such as a PI.      In this open-label study, 46 subjects will receive inhaled beclomethasone for 6 weeks from     Days 1 to 42. Subjects will be randomized into 1 of 3 groups, such that from Days 15 to 42,     18 subjects will add no additional study drugs, 14 subjects will add RTV 100mg twice daily,     and 14 subjects will add DRV/r 600/100mg twice daily. Pharmacokinetic sampling for     beclomethasone and beclomethasone-17-monopropionate levels will occur on Days 14 and 28.     Pre-cosyntropin cortisol levels and a low-dose adrenocorticotropic hormone (ACTH) stimulation     test will be performed on all subjects on Days 1, 14, 28, and 42. Data from this     investigation will determine whether RTV and/or DRV/r, potent CYP 3A4 inhibitors, alter the     pharmacokinetics of beclomethasone and its active metabolite,     beclomethasone-17-monopropionate (primary objective), and whether or not a possible increase     in systemic bioavailability of beclomethasone and beclomethasone-17-monopropionate alters     pre-cosyntropin cortisol levels and responses to ACTH stimulation test over a 4-week period     (secondary objective). Results from this investigation will provide pharmacokinetic and     pharmacodynamic data to assist clinicians in determining whether inhaled beclomethasone is an     appropriate option in HIV-infected patients requiring concomitant therapy with an inhaled     corticosteroid and PIs.   "
235305|NCT00936806|"     Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during     anaesthesia.   "
235306|NCT00936819|"     This will be the first clinical trial to include a strategy designed to enhance the function     of autologous progenitor cells by overexpressing eNOS, and the first to use combination gene     and cell therapy for the treatment of cardiac disease.   "
235307|NCT00936832|"     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) together with     sunitinib malate may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving sunitinib malate together with     combination chemotherapy works as front-line therapy in treating patients with metastatic     rectal cancer that cannot be removed by surgery.   "
235308|NCT00936845|"     To collect and analyze data on females with hemophilia so as to better define the difference     between the study population and the male population with hemophilia.   "
235309|NCT00936858|"     Since thyroid cancer becomes refractory to radioactive iodine, treatment options are very     limited. Tyrosine kinase inhibitors such as sorafenib have recently shown promise. This trial     seeks to expand treatment options for this disease with a new, oral drug called RAD001. It is     an inhibitor of the mTOR pathway and has shown activity in neuroendocrine cancers of the     gastrointestinal tract and has been approved for the treatment of metastatic renal cell     cancer.   "
235310|NCT00936871|"     This study has been designed to investigate the effect of lersivirine on the QT/QTc interval     in order to help establish the safety profile of lersivirine.   "
235311|NCT00936884|"     The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of     subcutaneous (injection beneath the skin) MOA-728 versus placebo in Asian Adult subjects with     opioid-induced constipation and advanced illness   "
235312|NCT00936897|"     This is a multi-center, randomized, open-label, parallel group, study being conducted in the     United States and in Europe in postmenopausal women. Approximately 800 subjects will be     randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or     ibandronate 150mg PO QM.   "
235313|NCT00936910|"     The purpose of this study is to evaluate the usefulness of antifungal lock therapy with     liposomal amphotericin B (Ambisome), in combination with systemic antifungal(s), in patients     with catheter-related blood stream infections with fungal organisms, whose catheter has not     been removed because of the continuing critical need for central line access. The primary     group of potential patients will be those with intestinal insufficiency, including post-op     small bowel transplant recipients.      The recommendation of the Infectious Disease Society of America (IDSA) is to remove all     catheters with fungal infections and treat systemically for 14 days after the last positive     culture. However, in certain intestinal failure patients, removal of an infected line might     significantly reduce or eliminate intravenous (IV) access and create a life threatening     situation. Thus, the investigators' aim is to determine the usefulness of antifungal lock     therapy in intestinal failure patients whose catheter has not been removed. The     investigators' hope is to salvage central line catheters rather than to remove them.   "
235314|NCT00936923|"     A prospective, randomized, open-label, stratified, controlled clinical trial to evaluate     whether long term furosemide therapy (1 year) would preserve urine volume and/or residual     renal function (RRF) and improve fluid state in continuous ambulatory peritoneal dialysis     (CAPD) patients.   "
235319|NCT00936988|"     This multicenter, open-label, single-arm, extension study was designed to evaluate long-term     tolerability, safety, and efficacy of cinacalcet. Subjects were enrolled immediately after     they completed the parent study, 990120. All subjects began treatment with 30 mg cinacalcet     twice daily (BID), with dose adjustments made per protocol-specified guidelines. The study     consisted of 2 consecutive phases that occurred in the following order: a dose-titration     phase lasting 12 weeks and a maintenance phase lasting approximately 4½ years.   "
235354|NCT00937456|"     To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in     Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.   "
235441|NCT00938275|"     The primary objective of this study is to assess the pharmacokinetic profile of a single 500     mg dose of SRT2104 administered as an oral suspension and a capsule formulation to normal     healthy male and female volunteers in both the fed and fasted state.      The secondary objective is to assess the safety and tolerance of SRT2104 administered as an     oral suspension and as a capsule formulation to healthy male and female volunteers in both     the fed and fasted state.   "
235442|NCT00938288|"     The aim of this study is to determine the pharmacokinetics, safety and tolerability of     KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.   "
235320|NCT00937001|"     ICU-acquired weakness represents a common and often devastating disease process which affects     greater than 50% of critically ill patients. This pathogenesis of this acquired disease is     multifactorial and results in variable severity, ranging from mild, transient to severe,     permanent dysfunction of peripheral nerves in additional to muscle. In affected patients,     weakness may persist for months to years after the acute phase of their illness, and has been     implicated as a major contributor to decreased functional status and quality of life. Muscle     ultrasound has been validated for assessment of muscle size as well as diagnosis of myopathic     and neuropathic changes in patients with other known neuromuscular diseases. The use of     muscle ultrasound or other imaging modalities for diagnosis or monitoring of ICU-acquired     weakness has not been studied, although a single study using muscle ultrasound has shown     significant change in muscle size in ICU patients receiving high dose corticosteroids and a     prolonged course of paralytic agents. The investigators plan to use multiple modalities to     examine skeletal muscle catabolism, function, and structure in patients during critical     illness and recovery. The investigators will combine physical exam, hand grip dynamometry,     electrophysiologic studies, serum biomarkers, muscle biopsies, and muscle ultrasound to     assess a group of critically ill patients during their hospital stay. The investigators will     obtain additional data, including neuropsychiatric assessments, severity of illness scores,     administration of potentially harmful medications, and pertinent daily laboratory data. This     study will last approximately 12 months.   "
235321|NCT00937014|"     The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day)     of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the     first four months of life as compared to infants fed a standard infant formula.   "
235322|NCT00937027|"     The purpose of this study is to compare the safety and pharmacokinetic properties (the     absorption, distribution and excretion) of two preparations of aminopterin (0.25 mg tablets     and 1.0 mg tablets) following oral administration by subjects with moderate to severe     psoriasis.   "
235323|NCT00937040|"     The purpose of this study is to compare the ADHD symptom response of adults with ADHD treated     with OROS MPH to those treated with placebo.   "
235324|NCT00937053|"     The purpose of this study is to determine if maintaining a high hemoglobin level in children     that underwent bone marrow transplant will accelerate the neutrophil recovery.   "
235325|NCT00937066|"     This study is an economic evaluation of Symbicort (Budesonide/formoterol) as maintenance and     reliever therapy (SMART) versus its competitive alternatives.      The aims of this study are:        -  To estimate the relative effectiveness of each one of the alternatives in the management          of patients with moderate to severe asthma through a systematic review for the following          outcomes:             -  Cumulative incidence of asthma severe exacerbations symptoms             -  Safety of each alternative (frequency of adverse events and complications due to               the medications)        -  To estimate the direct medical costs of treating with each pharmacologic alternative:          Symbicort as SMART versus increased use of inhaled corticosteroids or Adding long-acting          inhaled beta 2 agonist plus inhaled corticosteroids.        -  To create a decision analysis model (decision tree) that allows comparisons between the          alternatives on expected values and costs.        -  To calculate the average and incremental cost-effectiveness ratios.        -  To carry out a sensitivity analysis to test de robustness of the cost-effectiveness          results allowing for reasonable changes in expected values and costs.   "
235326|NCT00937079|"     The purpose of this study is to determine whether the investigators' new imaging modality     (111In-exendin-4) has advantages in detecting insulinomas in comparison to conventional     imaging.   "
235327|NCT00937092|"     The aim of this study is to compare the effects of high-dose furosemide versus low-dose     furosemide combined with low-dose dopamine on diuresis, renal function, electrolyte balance,     and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart     failure.   "
235328|NCT00937105|"     This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and     marketed lotrafilcon A (Ciba Vision, Air Optix Night & Day Aqua) soft contact lenses for     daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic     (farsighted) patients with minimal or no astigmatism and no contraindications to DW lens use     will be followed for 1 year. The primary outcome is the risk of development of a corneal     inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main     exposure of interest is microbial contamination of study lenses.   "
235329|NCT00937118|"     The management of significant duodenal injuries and combined duodenal-pancreatic injuries     continues to be challenging and controversial, and several techniques have been advocated     over the years. One technique surgeons employ is the damage control/planned reoperation     strategy. At the trauma center, the advent of damage control and other planned re-operation     strategies has resulted in an evolution in the investigators management of duodenal     lacerations and combined duodenal-pancreatic injuries. In this retrospective review, the     investigators intend to quantify the investigators change in practice and to report its     outcome compared to previous practice.      Using the OHSU Trauma Laparotomy Outcomes Database, the investigators will identify all     patients receiving trauma laparotomy for a duodenal or duodenal/pancreatic injury for a     period of 20 years, from 1989-2009. A number of data points will be retrieved from patients'     medical records, including but not limited to grade of duodenal injury, mechanism of injury,     Injury Severity Score, and others.   "
235340|NCT00937274|"     This study hopes to demonstrate the potentials of a new form of therapy for childhood     diarrhea, a major cause of morbidity and deaths in Bangladesh and other developing countries,     and thus a priority for improving child health.   "
235818|NCT00935415|"     The aim of this study is to verify MNT time of onset of protection against EIB in asthmatic     children by evaluating different time intervals between dosing and challenge, after a     single-dose and after three days of once a day MNT administration.   "
235436|NCT00938210|"     The standard procedure for treating colonic cancer is changing from open surgery to     laparoscopic surgery. Following open colonic surgery patients are fatigued and loss body mass     and have a reduction in physical function, but the investigators do not know if this is also     the case following laparoscopic surgery.      This study examines how fatigue, quality of life, physical function, and body composition     changes following laparoscopic colonic surgery.      Patients are examined preoperatively and postoperative day 10 and 30.   "
235330|NCT00937131|"     TTP is a rare and serious blood disorder, characterized by the formation of small clots     (micro thrombi) within the circulation and can be fatal. The formation of blood clots occurs     primarily in the smaller blood vessels, the arterioles and capillaries, associated with     multisystem organ involvement, especially the brain and kidneys. TTP has an incidence of     approximately 1-3 people/million of the population/year.      TTP is due to a decrease in an enzyme, ADAMTS 13 that is released by cells lining blood     vessels (endothelial cells). ADAMTS 13 'cleaves' or breaks down very large von Willebrand     Factor (vWF) strands. vWF is used in blood clotting. Deficiency or inhibition of the enzyme,     results in release of the ultra large vWF into the circulation. Platelets bind to these ultra     large vWF multimers, promoting blood clot formation and platelet consumption     (thrombocytopenia). In more then 70% of TTP cases no precipitating cause can be found and the     majority of these patients have antibodies against ADAMTS 13. Plasma Exchange (PEX) was     introduced in the management of TTP in 1977 and the mortality of TTP patients has since     decreased from approximately 90% to 15-20%. PEX is essential in TTP treatment as plasma     contains the missing enzyme ADAMTS 13.      Rituximab (licensed and internationally used monoclonal antibody) selectively acts on white     blood cells known as B-lymphocytes or B cells that produce the antibody to ADAMTS 13. By     inhibiting ADAMTS 13 antibody production, ADAMTS 13 activity increases, resulting in     remission. Rituximab has been used in our institutions in patients with acute TTP that are     refractory to standard treatment - PEX. The resulting remission has been dramatic, with a     non-toxic side effect profile and no patients to date has relapsed (longest follow-up 19     months) following Rituximab therapy. Therefore, we plan to use Rituximab with PEX in patients     who present with acute TTP.   "
235331|NCT00937144|"     The investigators would like to study the endothelial function in sickle cell patients     without pulmonary hypertension in an in vivo method during a steady state condition before     and after sildenafil treatment for 1 month, and to study the effects of this nitric oxide     donor by measuring the Flow Mediated Dilatation, by measuring endothelial progenitor stem     cells colonies, and by measuring the effect of therapy on markers of inflammation (cell     adhesion molecules and cytokines).   "
235332|NCT00937157|"     This study will:        -  Explore whether GA decreases inflammation more on the 3T optimized protocol when          compared to the 1.5T standard protocol.             -  Compare whether the decrease in the cumulative number of Gd-enhancing lesions               significantly differs between pre-treatment (day 0) and post-treatment (12 months)               using 1.5T standard and 3T optimized protocols.        -  Investigate the correlation between MTR and the cumulative number and volume of Gd          enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with          GA.      This study suggests that GA may favorably affect early events in lesion formation, in     addition to exerting more transient beneficial effects on established areas of inflammation     and demyelination, and that this effect may be observed only with the 3T optimized protocol.   "
235333|NCT00937170|"     The purpose of this study is to compare results obtained with gender-specific and traditional     knee replacement systems design among women undergoing total knee replacement surgery. Women     who qualify and agree to participate will be randomly assigned to receive either a     traditional or gender-specific knee replacement. During surgery, measurements of bone     resection and bone-to-implant relationships will be recorded. At selected time intervals,     participants will be asked to fill out questionnaires regarding pain and function, will be     examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a     subset of participants will be randomly selected to undergo gait analysis to evaluate knee     motion and muscle function.   "
235334|NCT00937183|"     RATIONALE: Biological therapies, such as a dendritic cell vaccine made with a patient's     cancer cells, may stimulate the immune system in different ways and stop cancer cells from     growing.      PURPOSE: This phase I/II trial is studying the side effects of dendritic cell vaccine and to     see how well it works in treating patients with indolent B-cell lymphoma or multiple myeloma.   "
235335|NCT00937196|"     The objective of the present study was to examine the effects of a single placebo     intervention on blood pressure and to investigate autonomic and psychological mediating     mechanisms.   "
235336|NCT00937222|"     Peanuts and peanut butter contain high levels of monounsaturated fat (MUFA), arginine, fiber,     phytosterols, resveratrol and vitamin E that have the potential to reduce cardiovascular     disease (CVD) risk through improved blood glucose control and favorable modification of blood     lipids. When substituted for saturated fat in the diet, MUFA may have important metabolic     benefits for persons with diabetes. Therefore, the investigators propose to study the effects     of a peanut and peanut butter-enriched diet on markers of CVD risk factors in free-living     adults with diabetes residing in Southern California. This study's primary clinical outcome     will be high-density lipoprotein (HDL) - cholesterol. Secondary outcomes will include     additional serum lipids (total cholesterol, low-density lipoprotein (LDL) - cholesterol and     triacylglycerol), glucose, HbA1c, and anthropometry (body weight, body composition and waist     circumference). This study will provide vital information about the role of peanuts and     peanut butter in modulating blood glucose homeostasis and CVD risk factors among adults with     diabetes.   "
235337|NCT00937235|"     This study will examine the effect of combining prolonged exposure, a cognitive-behavioral     treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and     counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month     treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged     exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the     end of treatment and 6-month follow-up.      We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease     in cigarettes smoked will be greater among participants who receive the combined treatment     for both PTSD and smoking.   "
235338|NCT00937248|"     This study is designed to investigate whether or not the use of a customized vacuum     immobilization device (CVID) to immobilize rectal cancer patients undergoing preoperative     pelvic radiation therapy improves the positional stability of patients during each radiation     treatment. This question is more relevant now in the era of image-guided radiation therapy     (IGRT). Using state of the art IGRT technologies such as cone beam CT (CBCT) scanning,     assessments of the accuracy of treatment delivery can be made during a course of radiation     therapy allowing for patient set-up corrective strategies to be implemented. The use of CBCT     scanning may minimize any potential benefit of of a CVID if the patient's pretreatment     position can be corrected prior to treatment and our current immobilization strategy results     in a stable patient position. While it is seemingly intuitive to assume that the use of CVID     results in better patient stability, there is actually little data to support this.   "
235339|NCT00937261|"     The purpose of this study is to better understand brain function and psychiatric and     neurological illness when taking Invega or Risperdal. The objective is to compare the brain     effects of Invega to Risperdal in patients with Schizophrenia. This comparison will be     evaluated with PET imaging, fMRI, and neurological ratings and assessments.   "
235341|NCT00937287|"     African American women living in the rural South are twice as likely as Caucasian women to     develop cervical cancer and die of invasive cervical cancer at a higher rate than any other     racial/ethnic group in the US (1). Reasons for low HPV vaccination rates among rural African     Americans are not well understood. HPV vaccination compliance is likely influenced by     barriers to health care access, misinformation regarding vaccinations, religious beliefs     related to sexual health and behaviors, and mistrust of the medical community (2, 3). Because     the vaccination of minors requires primary caregiver consent, vaccination commitment and     compliance is strongly influenced by family beliefs and communication regarding health and     sexuality. To date, little research has examined the cultural, familial, and intrapersonal     influences on HPV vaccination compliance among rural African American women. This study will     address these gaps in the literature and provide data needed to develop effective     interventions and health promotion materials to encourage HPV vaccination among rural African     American women.      From a pool of approximately 800 families who are participating in ongoing longitudinal     research through the Center for Family Research at the University of Georgia, the     investigators will recruit 200 rural female African American youth aged 13-17 who have not     received the HPV vaccine and their primary caregivers (n=200) into an observational,     prospective study on vaccination commitment and compliance. The investigators hypotheses are     as follows:        1. Sociocultural factors that rural African Americans experience, including discrimination,          previous health care experience, religious beliefs, and community norms regarding HPV          vaccination and adolescent sexual behavior, will forecast primary caregivers' HPV          vaccination commitment and compliance for their daughters. The investigators also          predict that primary caregivers' HPV-related knowledge and attitudes will mediate this          association.        2. Sociocultural factors will influence sexual health-related family communication and          interaction, primary caregivers' and youths' HPV-related attitudes, and HPV vaccination          commitment and compliance.        3. Primary caregivers' attitudes, youths' attitudes, and family health communication will          contribute to youths' and caregivers' vaccination commitment and compliance.        4. Youths' sexual behavior will influence their attitudes, family health communication, and          vaccination commitment and compliance.   "
235342|NCT00937300|"     The aim of this study is to investigate the toxicity and immune response of therapy with     tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary     operation and radiotherapy.      Patient will receive a single treatment consisting of conditioning chemotherapy for seven     days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of     high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with     daily low-dose interleukine-2. Patients will be evaluated for toxicity and immune response.   "
235343|NCT00937313|"     -  To assess whether acute, moderate Champagne wine consumption modulates endothelial          function in healthy human volunteers.        -  To establish the bioavailability of Champagne wine polyphenols and their metabolism.   "
235344|NCT00937326|"     The primary purpose of this study is to determine the safety and tolerability of SRT2104     (0.25, 0.5, 1.0, and 2.0 g/day) in type 2 diabetic subjects when administered once daily for     28 consecutive days, and to characterize the pharmacokinetic profile of SRT2104 after a     single dose and multiple administrations in type 2 diabetic subjects.      The secondary purpose of this study is to determine the effect of SRT2104 (0.25, 0.5, 1.0,     and 2.0 g/day) when administered once daily for 28 consecutive days on fasting blood glucose     and insulin and post-prandial blood glucose and insulin in type 2 diabetic subjects.   "
235345|NCT00937339|"     The overall aim of the proposed study is to determine whether whole body vibration is     beneficial in promoting bone health, physical fitness and neuromotor performance in patients     with chronic stroke.      Subjects in the experimental group will undergo whole body vibration therapy (1 session per     day, 3 sessions per week) for 8 weeks. The vibration frequency used in this study will be     30Hz. The total duration of exposure to vibration for the experimental group will be 10     minutes. While standing on the vibration platform, patients will be instructed to repeat the     following set of light exercises: (1) light squatting,(2) deep squatting, (3) side-to-side     weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the     spot. The control exercise group, on the other hand, will perform the same exercise program     on the platform, but no vibration will be given. The training will be conducted by a     qualified personnel with physiotherapy background.      The outcome measurement will be performed 4 times: (1) immediately before the commencement of     intervention, (2) immediately after termination of treatment, (3) at 1 month after     termination of treatment. Each subject will be evaluated for bone markers, leg muscle     strength, balance, spasticity, and walking ability.   "
235346|NCT00937352|"     The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab     (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study     ELN115727-301 or study ELN115727-302.   "
235347|NCT00937365|"     This study compares three treatments for low back pain that started during pregnancy. The     study hypothesizes that exercise, spinal manipulation, and a mind-body technique called     neuroemotional technique (NET) equally affect pain intensity and disability associated with     pregnancy-related low back pain. The study also hypothesizes that pain intensity and     disability levels do not influence maternal heart rate variability (a measure of stress) and     intrauterine attachment (a measure of relationship quality). Ten women will additionally     provide blood and salivary oxytocin samples during pregnancy and periodically for three     months after birth. These women and their babies will also be videotaped playing for 5     minutes at 2 weeks, 6 weeks, and 3 months postpartum.   "
235348|NCT00937378|"     The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that     SER120 will decrease the number of nocturic episodes compared to placebo.   "
235349|NCT00937391|"     The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist     in children 2 months to < 2 years of age   "
235350|NCT00937404|"     The study will evaluate the safety and reactogenicity of PoliorixTM given as primary     vaccination course to Chinese children at 2, 3 and 4 months of age.   "
235351|NCT00937417|"     RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as docetaxel, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving vandetanib together with     docetaxel may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib given     together with docetaxel in treating patients with advanced solid tumors.   "
235352|NCT00937430|"     The purpose of this study is to find out if performing a bowel preparation prior to pelvic     organ prolapse surgery has any effect on the return of bowel function after surgery.   "
235364|NCT00937586|"     The overall purpose of this research is to determine if certain genes increase the chance of     developing prostate cancer and once diagnosed increase the chance of the prostate cancer     spreading to other parts of the body.   "
235365|NCT00937599|"     The purpose this research is to check if Brazil Nuts consumed improvement the metabolic     profile, state redox and endothelial function in obese adolescents.   "
235366|NCT00937612|"     The purpose of this study is to determine the treatment outcome of postoperative concurrent     chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.   "
235355|NCT00937469|"     The primary purpose of the trial is to examine the effect of the combination of social skills     training, parental training and standard treatment versus standard treatment in ADHD     patients.      The secondary purpose is to examine differences in the effect of the treatment in relation to     the different competences of attachment: secure attachment: unsecure dismissing, unsecure     preoccupied or disorganized attachment and in the categories; emotional openness, balance of     positivity / negativity to attachment figure/s, idealisation of attachment figure/s,     dismissal and/or derogation of attachment, the ability of conflict resolution,     disorganisation and coherence of the narrative description.      The tertiary purpose of the trial is to examine differences in the effect of the treatment in     relation to the degree of parents symptoms of ADHD.   "
235356|NCT00937482|"     This phase I trial is studying the side effects and best dose of cediranib maleate when given     together with whole brain radiation therapy in treating patients with brain metastases from     non-small cell lung cancer. Cediranib maleate may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Radiation     therapy uses high-energy x-rays and other types of radiation to kill cancer cells and shrink     tumors. Giving cediranib maleate together with radiation therapy may kill more tumor cells   "
235357|NCT00937495|"     This phase II trial is studying how well giving vorinostat together with bortezomib works in     treating patients with advanced soft tissue sarcoma. Vorinostat and bortezomib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     vorinostat together with bortezomib may kill more tumor cells.   "
235358|NCT00937508|"     This study is a randomized, double-blind, placebo-controlled clinical trial which evaluates     the efficacy of preoperative smoking counseling and varenicline (a medication approved by     Health Canada and FDA for quitting smoking) to provide long term smoking cessation (i.e.,     abstinence for at least one year) in surgical patients.      The primary hypothesis is as follows: A significant percentage of surgical patients will be     receptive to smoking cessation interventions in the pre-admission clinic and will refrain     from smoking at 24 and 52 weeks after starting the treatment. The secondary hypothesis is as     follows: Patients who receive interventions but do not quit smoking will have reduced number     of cigarettes consumed/day or improved their readiness to quit smoking at 24 and 52 weeks     after starting the treatment.   "
235359|NCT00937521|"     This study is aimed at assessing the safety and immunogenicity of different doses and     formulations of a new Novartis Meningococcal B Recombinant Vaccine.   "
235360|NCT00937534|"     The purpose of this study is to compare and assess the safety and pharmacokinetic     characteristics after oral administration of fimasartan (BR-A-657∙K) in healthy elderly and     young male volunteers.   "
235361|NCT00937547|"     1. Hypothesis:           If high risk genotypes of human papillomavirus (HPV) is the cause of cervical cancer          worldwide, the genotypes associated with cervical cancer in Venezuela would be the same          types found in other countries.        2. Objectives:      Primary objective:      The objective of this investigation is to determine the presence and genotypes of HVP     infection in cervical intraepithelial neoplasia grade 2/3 (CIN 2/3), and Stage I cervical     epidermoid carcinoma and cervical adenocarcinoma.      Specific objectives:      To establish the presence of HPV in cervical cancer patients in Venezuela by geographic     distribution.      To establish which HPV types are linked with cervical cancer in Venezuela by geographic     distribution.   "
235362|NCT00937560|"     This single arm study evaluated the efficacy and safety of first-line chemotherapy with     carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with     epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8     3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each     cycle, paclitaxel 80 mg/m^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an     area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy,     bevacizumab could be continued to be given as a monotherapy.   "
235363|NCT00937573|"     The effectiveness, safety, and deliverability of second generation drug eluting stents (DES),     including Xience V, will need to be examined in real world patients to provide the same level     of evidence base and comfort that has accompanied the use of the first generation devices.     Randomized clinical trials provide the fairest evaluation of outcomes by controlling for     confounding patient and procedural characteristics; however, randomized clinical trials also     exclude the very high risk patients that account for upwards of 80% of real world patient     populations such as those at Wake Forest University Baptist Medical Center (WFUBMC).      Clinical follow-up data including non-fatal MI, all cause mortality and stent thrombosis, as     well as medications compliance, of patients undergoing stent therapy including Xience V in a     real world patient population will be collected at WFUBMC. Existing data for several control     groups will be used to compare outcomes with Xience V including a consecutively treated bare     metal stent (BMS) cohort of 1,200 patients, and a DES cohort of 1,200 patients (900     sirolimus-eluting and 300 paclitaxel-eluting) treated between April 2004 and April 2005.     Patients undergoing stent therapy in the year prior to use of Xience V, and contemporaneous     patients receiving non-Xience V stent therapy during Xience V use will serve as additional     controls. All patient data will be de-identified using unique blinded identification codes     after data collection is completed.      The null hypothesis of this study states that safety outcomes (stent thrombosis, non-fatal     MI, death) with Xience V will be equivalent to historical and contemporaneous controls;     effectiveness outcomes (target lesion and target vessel revascularization) with Xience V will     be superior to historical and contemporaneous BMS controls, and equivalent to historical and     contemporaneous DES controls; and the need for crossover to another stent type will be equal     to that observed with historical DES controls. Outcomes will be reported using contemporary     measures of clinical outcomes and analyzed using Cox proportional hazards survival analysis     methodology. These data should provide important information on the clinical effectiveness     and safety of Xience V in routine practice.   "
235367|NCT00937625|"     The aim of this study is to investigate the toxicity and clinical response of therapy with     tumor infiltrating lymphocytes as treatment for advanced melanoma.      Patient will receive a single treatment consisting of conditioning chemotherapy for seven     days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of     high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with     daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and     immune response.      After the first 6 patients the treatment with IL-2 has been changed to include higher doses     of IL-2 (see intervention)   "
235437|NCT00938223|"     This is an open-label, phase II study of a vaccine comprising melanoma peptides and a tetanus     helper peptide, administered in GM-CSF-in-adjuvant. Patients will be randomized to receive     one of two different vaccine regimens. Patients will be stratified by stage of disease (IIB     versus III versus IV).   "
235438|NCT00938236|"     This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the     prevention of chronic rejection in lung transplant recipients.   "
235368|NCT00937638|"     The proposed research will provide important information about the role of 2 intervention     diets that provide different amounts of lean beef and meet current nutrient recommendations     for the treatment of Metabolic Syndrome (MetSyn), a chronic disease that is still increasing     in prevalence at alarming rates. The experimental and diet designs will enable us to evaluate     lifestyle interventions for MetSyn for persons who maintain weight, lose weight and maintain     their weight loss, as is currently recommended in clinical practice. Importantly, the     investigators will compare a diet high in lean beef (5 oz/day) which is compositionally     similar (i.e., energy and nutrients) to the modified-DASH diet, a low beef diet which has     become the Gold Standard for the management of cardiovascular disease (CVD) risk factors,     including MetSyn. In addition, the investigators also will evaluate a moderate-high protein     diet (BOLD+) that is higher in total protein (from mixed sources including lean beef,     7oz/day) than the BOLD diet, on CVD risk factors in persons with MetSyn. A follow-up study     was conducted to assess dietary compliance in a sub-sample of the population at 12-months;     participants were not informed of this end-point and additional consent was obtained.      Hypotheses:        1. Healthful isocaloric diets that include lean beef as the primary source of protein (BOLD          diet) with average (18%; BOLD) or moderate-high (28%; BOLD+) total protein intake will          show similar or greater reductions in CVD risk, respectively when compared to a          modified-DASH diet.        2. A healthful weight-loss diet, including lean beef as the primary source of protein in a          high-moderate protein diet (BOLD+ diet), plus regular exercise (BOLD+ + ex) will reduce          body weight equal to that of a BOLD + ex and DASH + ex intervention, but may improve CV          risk factors (such as BP and TG), and therefore reduce the prevalence of MetSyn more          than a BOLD + ex and DASH + ex intervention.        3. The BOLD diet will be more effective than the modified-DASH diet, and the BOLD+ diet          more effective than the BOLD diet in maintaining the CVD benefits attained during phases          1 and 2. Dietary adherence will be better on the BOLD and BOLD + diets compared with the          modified DASH diet.   "
235369|NCT00937651|"     Study objective:        1. To evaluate the antihypertensive efficacy, safety and tolerability of the drug after the          oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential          hypertension.        2. To review the pharmacokinetic profile after the multiple administration and the          pharmacodynamic profile regarding the renin-angiotensin system, after the oral          administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential          hypertension.        3. To determine the dose for the clinical study at the next phase by analyzing the          relationship between the antihypertensive efficacy and pharmacokinetic • pharmacodynamic          results.   "
235370|NCT00937664|"     The primary purpose of this study is to find out what the maximum tolerated dose is for an     experimental drug called AZD7762 when given with the approved drug gemcitabine based on the     side effects experienced by patients that receive both drugs.   "
235371|NCT00937677|"     The primary objective of this study is to define the effect of Tysabri in patients with     relapsing-remitting (RR) multiple sclerosis (MS) over 2 years. The investigators will also     explore the extent of remyelination in MS patients treated with Tysabri over 2 years.      A secondary objective of this study is to investigate differences in the capacity for     remyelination between patients who do or do not respond to Tysabri monotherapy during the     same 24 months.      A tertiary objective of this study is to monitor Tysabri effect in MS antiphospholipid     antibodies positive and MS antiphospholipid antibodies negative patients and to determine     perfusion differences according to the antiphospholipid antibodies positivity status.   "
235372|NCT00937690|"     Design: this is a pilot study of infrared imaging of cutaneous lesions in patients and     volunteers with and without clinically detectable melanoma, and with one or more palpable     cutaneous lesions eligible for this imaging study. Participants will be evaluated with     infrared camera imaging at cutaneous sites with known melanoma deposits, suspected melanoma     deposits that are to be biopsied, or at cutaneous sites with other lesions, including other     skin cancers, benign inflammatory lesions, benign neoplastic lesions (lipomas, epidermal     cysts, dermatofibromas, scar, healing wound, etc.).   "
235373|NCT00937703|"     TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of     the study is to show that during the initiation of a basal insulin treatment , a computerized     decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks     to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at     the end of 4 mouths as compared with conventional care.      Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a     telemonitoring system compared to the reference group at 4 months.   "
235374|NCT00937716|"     The overarching goal is to identify imaging markers that will predict treatment response, and     to confirm or validate these biomarkers using anatomical studies of postmortem tissue. Early     detection of drug response would yield specific treatment strategies that are tailored to the     individual, thus improving both the quality of life of the patients and drastically reducing     the costs associated with unsuccessful treatment strategies.   "
235375|NCT00937729|"     In case of lack of compliance in HIV1 patients, the investigators hope to prove that     enfuvirtide injection during almost 3 months, with nurse help at home and therapeutic     education may contribute to obtain a good compliance more than 95% in these patients.   "
235376|NCT00937742|"     The primary working hypothesis is that consuming processed tomatoes frequently/daily will     favorably improve endothelium and platelet function disease-risk biomarker profiles in adult     men and women compared to consuming no or relatively low amounts of processed tomatoes.   "
235392|NCT00937950|"     This study is designed provide up to four years of annual oncogenic HPV DNA testing and     cervical cytology examination for NCT 00122681 study subjects who displayed normal cervical     cytology but tested positive for oncogenic HPV infection at their last NCT 00122681 study     visit (Visit 10, Month 48).      This follow-up study will also be offered to subjects who were pregnant at their last NCT     00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at     that visit.      The objectives & outcome measures of the primary phase (study 008/580299) are presented in a     separate protocol posting (NCT00122681).   "
235404|NCT00929006|"     The purpose of this study is to determine if in late pubertal girls without hyperandrogenemia     (HA), progesterone (P) will acutely reduce waking lutenizing hormone (LH) frequency to a     greater extent than sleep-associated LH frequency. We hypothesize that in late pubertal girls     with HA: (a) waking and sleep-associated LH frequency will be elevated (compared to     controls); and (b) P will suppress waking LH frequency to a lesser degree than it does in     girls without HA.   "
235439|NCT00938249|"     The purpose of the study is to determine the effect of monascus garlic fermented extract on     serum lipid concentrations in subjects with moderately elevated serum triglyceride.   "
235440|NCT00938262|"     To evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.   "
235443|NCT00938301|"     The purpose of this first in human (FIH) study is to investigate the safety, tolerability,     pharmacokinetics ( how the body handles the drug) and pharmacodynamics (how the drug affects     the body) of PF-04455242-01 in healthy adult volunteers.   "
235377|NCT00937755|"     Schizophrenia is one of the most severe mental illnesses. The antipsychotic drugs, introduced     in early 1950s, have revolutionized the treatment of schizophrenia. About 2 to 4 times as     many patients relapse when treated with a placebo as do those treated with antipsychotic     drugs. For these medications to be maximally beneficial, they must have an acceptable side     effect profile and be taken as prescribed. One untoward effect of many antipsychotic drugs is     weight gain. The extent of weight gain apparently varies by drug, which may be because of     drugs'differing degrees of action on serotonergic, dopaminergic, histaminergic, and other     neurotransmitter systems. Obesity is a threat to health and longevity. Weight gain may also     cause patients taking antipsychotic medication to discontinue their medication, which may     predispose them to relapse.      The pattern of weight gain and metabolic disturbance may vary between the different     antipsychotic agents. The underlying mechanism and treatment of these adverse metabolic     effects remain unclear. This study will recruit 60 schizophrenic patients during. The     patients received monotherapy with atypical antipsychotics (olanzapine, quetiapine, or     risperidone). The assessment of metabolic profile will be monitored at baseline, week 2, week     4, and week 8. The measurements include anthropometrical parameters, body composition,     glucose level, insulin level, lipid profile, and leptin level. Intra-venous glucose tolerance     test will be used to assess the insulin secretion and insulin sensitivity.      This proposal broadly aims to discover the underlying mechanism of antipsychotics induced     metabolic disturbance and develop efficient treatment to correct it.   "
235378|NCT00937768|"     This randomized phase II trial studies the side effects and how well giving leuprolide     acetate or goserelin acetate works compared to observation in treating patients with     high-risk prostate cancer who have undergone radical prostatectomy. Androgens can cause the     growth of prostate cancer cells. Antihormone therapy, such as goserelin acetate and     leuprolide acetate, may lessen the amount of androgens made by the body and thus control     prostate cancer growth. Many times, after surgery, the tumor may not need more treatment     until it progresses. In this case, observation may be sufficient. However, in some prostate     cancers there is a chance that tumors can re-grow despite surgery based on certain high risk     features.   "
235379|NCT00937781|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at tumor tissue samples from patients with melanoma     treated on clinical trial EST-1690.   "
235380|NCT00937794|"     This study is being conducted to identify pediatric patients with Hunter syndrome who have     neurodevelopmental disease characteristics, who are currently receiving treatment with     Elaprase, and who may be suitable to participate in a clinical study with an investigational     agent.   "
235381|NCT00937807|"     The purpose of this study is to compare the hemodynamics effects of two usual hypnotic agents     (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid     endarterectomy in elderly patients. The hypothesis is that the use of the LENOXe ™ (xenon 100     % v/v) allows to obtain per-operating hemodynamic stability non inferior than with     sevoflurane.   "
235382|NCT00937820|"     The study objective is to evaluate the efficacy and safety of oral YM150 for 52 weeks in     patients with a history of venous thromboembolism.   "
235383|NCT00937833|"     The purpose of this study is to determine the impact of an absorbable urethrovesical sling on     the post-operative return of urinary continence after robot-assisted radical prostatectomy.   "
235384|NCT00937846|"     GSK1034702 is being developed for improving cognitive impairment in diseases such as     Alzheimer's disease and schizophrenia. This study will be done in healthy men to investigate     how much of the study drug gets into the brain. This will be done using Positron Emission     Tomography (PET).   "
235385|NCT00937859|"     The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that     SER120 will decrease the number of nocturic episodes compared to placebo.   "
235386|NCT00937872|"     The primary objective of this study is to determine the absolute bioavailability of SRT2104     as a 250 mg suspension, and to define the intravenous pharmacokinetics of SRT2104.      The secondary objective of this study is to assess the potential systemic metabolite burden     of SRT2104, and to provide plasma and urine samples for subsequent metabolite profiling and     identification.   "
235387|NCT00937885|"     Reminiscence is the systematic use of memories and recollections to strengthen self-identity     and self-worth. The study aim was to investigate the consequences for nursing home residents     and staff of integrating reminiscence into daily nursing care. Ten nursing homes were     randomised into either an Intervention Group, who implemented reminiscence, or a Control     Group, who continued with usual care. Data were collected at baseline and again 6 and 12     months after the intervention start. Results suggested that use of reminiscence can improve     residents' quality of life and possibly delay progression in dementia symptoms. Nursing staff     can experience greater satisfaction with personal and professional roles and develop a more     positive view of the residents.   "
235388|NCT00937898|"     The study is designed to assess the effects of a heart-healthy diet that includes lean beef     as the primary source of high quality protein on risk factors for cardiovascular disease.   "
235389|NCT00937911|"     The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of     venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower     extremities.   "
235390|NCT00937924|"     The purpose of this study is to compare meperidine/midazolam with diphenhydramine,     meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation     methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine     and promethazine) will improve sedation.   "
235391|NCT00937937|"     This phase II trial is studying the side effects and how well dinaciclib works in treating     patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
235403|NCT00938093|"     The research study proposed is designed to examine the outcomes of a cognitive behavioral     guided self-care intervention with older adults diagnosed with generalized anxiety disorder     and recruited from a primary care setting. It is hypothesized that the cognitive behavioral     guided self-care intervention will produce greater declines in worry and anxiety than     enhanced usual care.   "
235393|NCT00937963|"     Diacylglycerol (DAG) is a molecule that consists of two fatty acid chains bound by ester     links to a glycerol molecule, in the form of 1,2 and 1,3 structural isomers. Approximately     10% of the edible oils on today's market are comprised from DAG. DAG oil has a similar taste,     appearance, and fatty acid composition as conventional triacylglycerol oil (TAG; consists of     3 fatty acids chains bound to a glycerol molecule), yet recent studies suggest that due to     its different chemical structure, DAG oil may induce cardiovascular (CV) benefits.     Specifically, human studies in the United States (US) and Japan have shown that long-term     consumption of a diet containing DAG oil enhances loss of body weight and body fat compared     with TAG oil of similar fatty acid composition. In postprandial studies, serum triglycerides     (TG) and remnant like particle cholesterol concentrations, have shown to be lower following     ingestion of DAG-enriched oil compared to conventional dietary oil (e.g., soybean, corn), or     TAG oil. Therefore, DAG oil appears to be effective for preventing postprandial     hyperlipidemia, which is a risk factor for arteriosclerosis.      The hypothesis that the investigators propose in this pilot study is that intake of DAG oil,     compared to TAG oil will result in a lower LDL-C, and lower LDL-C/HDL-C ratio, as well as a     reduction in TG levels. Given the significance of such findings, if confirmed, the     investigators will evaluate other important clinical biomarkers for chronic disease (CV     Disease, type 2 diabetes, metabolic syndrome), such as insulin sensitivity and inflammation     [as determined by C-reactive protein (CRP), interleukin (IL)-1, IL-6 & tumor necrosis     factor-alpha (TNF-α)], which also may be beneficially affected by consumption of the palm DAG     oil. During the pilot study, the investigators will reserve serum/plasma samples so that     these additional assays may be run upon approval of the modification.   "
235394|NCT00937976|"     The primary objective is to test the hypothesis that periodontal intervention in dialysis     patients who have both periodontal disease and a historically high burden of cardiovascular     disease will result in a reduction of inflammatory markers and improvement markers of     nutrition health like albumin. Patients will be randomized to one of two treatment arms:     intensive periodontal therapy or control-delayed periodontal therapy. Eligible patients will     have 5 study visits over 7 to 12 months.   "
235395|NCT00937989|"     RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help     doctors learn more about improving the treatment process and improve patients' quality of     life.      PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for     patients with breast cancer.   "
235396|NCT00938002|"     Critically ill patients on a breathing machine are at risk of developing a type of pneumonia     called Ventilator Acquired Pneumonia (VAP). The purpose of this study is to determine if     regular lung rinses sent for microbiological testing can reduce the time to diagnose VAP. The     study also plans to test the accuracy and speed of a new technology, using multiplexed     automated digital microscopy, to identify the germs causing the VAP.   "
235397|NCT00938015|"     The aim of this study is to evaluate if the data obtained in controlled clinical trials are     confirmed when Enbrel is used in usual clinical practice in Belgium according to local     reimbursement criteria.   "
235398|NCT00938028|"     The purpose of this study is to evaluate the effects of storage and handling on fecal samples     collected for metabolomic, proteomic and microbiomic and analysis.   "
235399|NCT00938041|"     This multicenter study will determine the response rate, the complete response rate, duration     of response, time to progression, time-to-treatment failure, safety, and survival following     treatment with Iodine-131 Anti-B1 Antibody for the retreatment of patients with non-Hodgkin's     lymphoma who previously responded with a duration of response of at least 3 months to     Iodine-131 Anti-B1 Antibody therapy. Patients will undergo two phases of study. In the first     phase, patients will receive a dosimetric dose of unlabeled Anti-B1 Antibody (450 mg)     followed by Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131.     Whole body gamma camera scans will be obtained after the dosimetric dose and data from three     imaging time points will be used to calculate a patient-specific dose to deliver the desired     total body dose of radiotherapy. In the second phase, patients will receive the therapeutic     dose of unlabeled Anti-B1 Antibody (450 mg) followed by 35 mg of Anti-B1 Antibody labeled     with the patient-specific dose to deliver the desired whole body dose of radiation. Patients     will be treated with thyroid blocking medication at least 24 hours prior to the first     infusion and continuing for 14 days following the last infusion.   "
235400|NCT00938054|"     Autism is defined as a lifelong pervasive developmental disability, as such, symptom recovery     is considered rare. Reports by Lovaas and McEachin, Smith & Lovaas and more recently by     Cohen, Amerine-Dickens, & Smith, Smith Groen et al. and Sutera Pandey et al suggest that     intensive behavioral intervention programs during preschool years may result in improvement     to the point where some children no longer meet criteria for autism by the time they reach     school age. Similarly, there are a large number of anecdotal reports of children with autism     who, following intensive biomedical intervention (e.g., gluten/casein free diets, vitamin     supplements, chelation), are indistinguishable from their typically developing peers. The     goal of the current research is to characterize the behavioral and biological profiles of     children with autism who show significant symptom reduction such that they no longer meet     criteria for autism (Remitted Autism [REM-AUT]) and to contrast them with a group of children     who continue to meet criteria for autism (AUT) and to typically developing (TD) group of     children. Examining whether neurobiological and neurobehavioral symptoms commonly reported in     autism are as frequent and severe in children who have responded to treatment is an important     first step in determining what factors may contribute to symptom remission in autism. In     addition, understanding how children with remitted autism compare to typically developing     children will help us better understand whether symptom improvement is through remediation     (normalization of function) or compensation (achieving the same behavioral/adaptive outcome     but through an alternative process).   "
235401|NCT00938067|"     The purpose of this study is to provide American Indian trauma patients, treated at the     Harborview Level 1 urban trauma center, compassionate and culturally sensitive care and to     link them to care in their distant tribal communities. The specific aims include 1) interview     Native healers to gather information on culture-specific aspects of recovery from traumatic     injury and on linking care to tribal communities, 2) conduct a randomized controlled trial to     evaluate the implementation and effectiveness of the intervention. The investigators     hypothesize that intervention patients will demonstrate greater improvement than controls in     post-traumatic stress disorder (PTSD) symptoms, depression, functioning, diagnoses, and fewer     new injuries during the 6 months after the index injury.   "
235402|NCT00938080|"     The purpose of this study is to assess the safety and tolerability of AG013 (genetically     modified L. lactis bacteria engineered to secrete human Trefoil Factor 1), and to explore the     ability of AG013 to attenuate the course and severity of oral mucositis (OM) in subjects     receiving induction chemotherapy for the treatment of head and neck cancer.   "
235405|NCT00929019|"     1. Rationale           Immunotherapy applying ex vivo generated and tumor antigen-loaded dendritic cells (DC)          has now successfully been introduced in the clinic. A limited, but consistent, number of          objective immunological and clinical responses have been observed. Most of the          successful results have been observed in patients with minimal residual disease, rather          than patients with advanced metastatic disease. Moreover, the investigators' preliminary          results show that presence of tumor epitope specific T cells in biopsies taken from          delayed type hypersensitivity (DTH) reaction sites highly correlates with prolonged          progression free survival (PFS).           Within uveal melanoma patients, a group with high risk of metastatic disease can be          identified on basis of tumor specific genetic changes in loss of chromosome 3.           At present no standard adjuvant or systemic treatment is available. Applying DC-based          immunotherapy in this group of high risk patients might reduce the risk of recurrence          without interference in the current treatment guidelines.        2. Objectives           In this joint clinical study of Radboud University Nijmegen Medical Centre (RUNMC) and          Rotterdam Eye Hospital, the investigators aim to determine the in vivo immunological          response induced in high risk uveal melanoma patients vaccinated with mRNA-transfected          DC.        3. Study design           This study is an open label non-randomized phase II intervention study.        4. Study population           The investigators' study population consists of HLA-A2 positive patients with a high          risk uveal melanoma with proven expression of melanoma associated antigens tyrosinase          and/or gp100.        5. Main study endpoints      This is an exploratory study aiming to demonstrate proof of principle. The first study     endpoints are in vivo immunological response induced in high risk uveal melanoma patients     vaccinated with mRNA-transfected DC, administered i.v./i.d. and toxicity. Secondary study     endpoints are progression free survival, overall survival, and toxicity.   "
235406|NCT00929032|"     Study summary: Liver transplantation and the reticuloendothelial clearance capacity.      The purpose of this study is to evaluate the effect of liver transplantation on the immune     system.      This study will involve the taking of a number of observations but does not involve any     treatment, which differs from normal care. Indications for transplantation are solely based     on the best clinical practice, which is usually performed at the department.      The study measures liver function based on the clearance of different marker substances by     the liver. These substances are given intravenously and their clearance will be measured from     bloodstream.      All substances used in this study are registered in the United Kingdom for clinical     applications and already used in clinical practice over years. They are safe and without any     risk to harm individuals under study. Furthermore no side effects or any symptoms caused by     the administration of these substances are expected.      Measurements of liver function are undertaken before transplantation, 1 and 7 days following     the transplant. There is no restriction from any of the patient's prescribed medication. All     blood samples will be removed from the cannula (drip) and will not require repeated     injections. It is hoped that this research will lead to a greater understanding of the     effects of liver transplantation on the immune system.   "
235407|NCT00929045|"     The purpose of this study is to look at the relationship between growth hormones, and     recovery from a TBI - traumatic brain injury. It is believed that a TBI may interfere with     the body's ability to produce growth hormones. These hormones may be needed by the body for     growth, mental development and sexual maturation.   "
235408|NCT00929058|"     Rationale: The introduction of angiogenesis inhibitors has remarkably improved treatment of     patients with several types of cancer. One of the most common side effects of angiogenesis     inhibitors is hypertension. In patients treated with bevacizumab hypertension had an overall     incidence up to 32%. The etiology of hypertension caused by treatment with angiogenesis     inhibitors is unclear.      Objective: To study if arterial bevacizumab infusion causes acute vasoconstriction using     plethysmography in healthy volunteers.   "
235409|NCT00929071|"     The study doctor will give EVOLENCE® mixed with Lidocaine to people in this study to see if     it effectively reduces pain while injecting and works to correct nasolabial wrinkles.      The product being used in this study is EVOLENCE®, which is currently marketed in the United     States for the cosmetic correction of soft tissue contour deficiencies (including wrinkles),     and been approved by the U.S. Food and Drug Administration (FDA).   "
235410|NCT00929084|"     The purpose of this study is to evaluate in a randomized controlled trail, an innovative     cancer communication strategy to help African American breast cancer patients cope with a     variety of challenges during and after treatment and to better adhere to recommended     treatment guidelines and follow-up care.   "
235411|NCT00929097|"     The aim of this study is to improve clinicians' calculation, interpretation and communication     of familial colorectal cancer risk, as well as patients' risk perception and uptake of     referral for genetic counselling or for surveillance by colonoscopy for their relatives at     risk.   "
235412|NCT00929110|"     This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily     (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic     obstructive pulmonary disease.   "
235413|NCT00929123|"     The purpose of this study was to determine the effect of a manual therapy technique (neural     mobilization) on measures of clinical pain and function, experimental pain sensitivity, and     on the function of the median nerve in individuals with carpal tunnel syndrome. The     investigators hypothesized that individuals receiving a neural mobilization technique known     to directly stress the median nerve would demonstrate greater improvements in clinical pain     and function, experimental pain sensitivity, and median nerve function than those receiving a     sham technique.   "
235414|NCT00929136|"     The aim of the study is to isolate the direct effects of endotoxin on glucose, lipid and     protein metabolism. Eight healthy volunteers are enrolled. The hypothesis is that endotoxin     will induce insulin resistance, lypolysis and proteolysis acutely.   "
235415|NCT00929162|"     The purpose of this study is to compare progression-free survival in patients with advanced     ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo     in combination with carboplatin+paclitaxel.   "
235416|NCT00929175|"     Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the     effect of treatment of OSAS on the resistant hypertension have no been established. In a     double-blind randomized clinical trial patients with resistant hypertension with at least     moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight     weeks in an ambulatory set. The investigators want to determine any difference on     hypertension control between the 2 management strategies.   "
235417|NCT00929188|"     The purpose of this study is to compare the safety and effectiveness of JNJ-42160443 with     placebo in the treatment of chronic, moderate to severe cancer-related pain in terminally ill     patients with a diagnosis of active cancer.   "
235418|NCT00929201|"     This study will demonstrate the bioequivalence of metformin after single dose administration     of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant     administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual     tablets after consumption of a high-fat meal.   "
235420|NCT00929227|"     Background:        -  Noninvasive cardiac stress testing is imperfect. Inconclusive test results generate          further expensive testing.        -  In patients with known or suspected coronary artery disease, both computed tomography          (CT) and magnetic resonance imaging (MRI) have been shown to provide suitable results          for detecting the disease. However, both types of scans have limitations in their          usefulness, and it is not known whether one is preferable in either accuracy or          cost-effectiveness.      Objectives:      - To determine the accuracy and cost-effectiveness of CT and MRI in subjects with a prior     inconclusive heart stress test.      Eligibility:      - Patients 18 years of age and older who have had an inconclusive heart stress test within     the past 90 days.      Design:        -  A blood test will be obtained prior to both heart tests. This will require less than a          teaspoon of blood.        -  A CT scan will be performed, accompanied by beta blocker medications (to slow heart          rate) or nitroglycerin (to enlarge blood vessels) to improve picture quality, as needed.        -  An MRI scan will be performed. Scans will be taken before, during, and after the patient          receives vasodilators (to increase blood flow to the coronary arteries and detect          blockages in heart blood vessels).        -  Heart rate and function will be monitored with an electrocardiogram.   "
235421|NCT00929240|"     This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda     (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer     who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients     will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each     cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not     progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of     each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone.     Study treatment will continue until disease progression, unacceptable toxicity, patient     request for withdrawal or end of study, and the target sample size is 100-500 individuals.   "
235422|NCT00929253|"     This study is designed to examine the effects of combined buprenorphine and voucher     incentives to promote abstinence from illicit opiate use, along with or without     computer-delivered therapy, during treatment of opioid dependence.   "
235423|NCT00929266|"     To study the in vivo life span in healthy volunteers of red blood cells generated in vitro     from autologous peripheral stem cells. The study will be carried out in 4 phases :        -  production in vitro of the equivalent of 1 ml of blood, i.e. 5x10e9 enucleated RBC from          mononuclear cells isolated from an HSC graft obtained from a healthy volunteers donor.        -  labeling of these cRBC with 51 Cr        -  reinjection of the autologous cRBC        -  follow up of the receivers for a maximum 33 days to measure the half-life span of the          injected cells.   "
235424|NCT00929279|"     In full responders to clopidogrel scheduled to undergo PCI for NSTEACS, the use of abciximab     bolus only plus 600 mg clopidogrel loading dose will result in a non-inferior inhibition of     platelet aggregation after 4 hours as measured by LTA (20micromol ADP) when compared with     abciximab plus infusion and 300 mg clopidogrel loading dose.   "
235425|NCT00929292|"     The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance     and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant     formula.   "
235426|NCT00929305|"     The purpose of this study was to determine whether the application of low level laser light     therapy to the neck and shoulder region is effective in reducing chronic neck and shoulder     pain of musculoskeletal origin.   "
235427|NCT00929318|"     Main goal of this clinical investigation is to investigate different cytokines in wound     fluids of euthyroid vs. hypothyroid patients. As a primary endpoint we want to evaluate if     different cytokine levels in euthyroid vs. hypothyroid patients exist and to what extent     these cytokines differ. Our targeted cytokines are: IL6, IL10, TNFa and MCP-1. From the     literature these 4 factors seem to be the most reasonable to measure and to focus on.     Additionally we focus on these 4 factors for financial reasons, technically there wouldn't be     a problem to measure more, which is correlated with higher costs. Besides, more than 6     factors would mean larger amounts of sample fluids needed, which would cause technical     problems. These factors don`t have to change in the same direction. Secondarily, we believe     that differences in cytokine profiles of hypothyroidism vs. euthyroidism will correlate to     differences in duration and clinical characteristics of the wound healing process.   "
235428|NCT00938106|"     Patients with cervix cancer usually require external radiation given to the whole pelvis then     an internal radiation boost, also called brachytherapy, to treat any remaining tumour.     Standard brachytherapy has been used successfully for many years, but does not take into     account differences in the shape of the tumour or normal structures between patients. This     study aims to implement individualized -optimized- brachytherapy, based on international     recommendations. MR scanning with the intra-uterine applicator in place allows improved     identification of residual tumour and normal structures, allowing brachytherapy to be     individualized for each patient with the aim to reduce side-effects and improve outcome.     Additionally, repeating MR scans during brachytherapy treatment will allow further assessment     on motion of the applicator during treatment and the effect on radiation dose. Sexual health     assessments aim to identify the relationship between sexual health and treatment effects.   "
235429|NCT00938119|"     This multicenter, prospective, observational registry will assess efficacy and safety     outcomes associated with percutaneous coronary intervention (PCI) with implantation of the     CYPHER Select™+ Sirolimus-eluting Coronary Stents in Chinese diabetic patients with coronary     artery disease in routine clinical practice.   "
235430|NCT00938132|"     To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety     of warfarin in healthy male volunteers.   "
235431|NCT00938145|"     RATIONALE: New diagnostic procedures, such as 3 Tesla magnetic resonance imaging (MRI), may     help find bladder cancer and learn the extent of disease.      PURPOSE: This clinical trial is studying how well 3 Tesla MRI works in finding cancer in     patients with bladder cancer.   "
235432|NCT00938158|"     The purpose of this study is to assess the pharmacokinetics and safety of a single     subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with     varying degrees of renal function, including subjects requiring hemodialysis.   "
235433|NCT00938171|"     The purpose of this study is to determine therapeutic benefits by local anesthetic technique     for breast cancer.   "
235446|NCT00938340|"     The purpose of this study is to evaluate the acute, postprandial effects and mechanism of     action of various walnut components (separated nut skins, de-fatted nut meat, nut oil) versus     whole walnuts on oxidative stress, inflammation and measures of platelet and endothelial     function in healthy adults with moderately elevated cholesterol levels.   "
235447|NCT00938353|"     Acute laryngotracheobronchitis, better known as croup, is one of the common respiratory     complaints among children and the most common cause of airway obstruction in children aged     six months to six years. Patients with croup are typically visited by physicians during two     peak time periods throughout the year. The first one is in the autumn, usually as a result of     parainfluenza virus, and the second peak occurs in early winter, a consequence of RSV. Croup     affects males more commonly than females and affects children between the ages of 6 months to     6 years. The incidence of croup peaks in children at 2 years of age; croup in older children     is uncommon, and recurrent episodes are frequently observed.      Croup symptoms are generally short-lived, with about 60% of children showing resolution of     their barky cough within 48 h. However, a few children continue to have symptoms for up to 1     week. Although most children with croup recover without specific treatment, up to 15% require     hospital admission, and, among those admitted, up to 5% may require intubation.      Nebulised adrenaline is effective but it has a short duration of action and potentially     dangerous side effects, and it is therefore not recommended for use in the community in     mild-moderate Croup.      Oral and intramuscular steroid treatment, when given in adequate doses in hospital, has been     shown to be effective for moderate to severe croup in a number of trials and a meta analysis.      It has been suggested that nebulised administration is superior to the oral or intramuscular     route of administration for a more rapid onset of action and fewer side-effects.      This study is aimed to demonstrate the effectiveness of nebulised steroid administration as     beclomethasone dipropionate in croup patients compare to placebo.   "
235448|NCT00938366|"     The purpose of the study is to assess the influence of pantoprazole on the pharmacokinetic     profile of cladribine, especially in terms of extent of absorption of cladribine since     pH-modifying drug may potentially affect the stability of cladribine and thereby its     bioavailability   "
235449|NCT00938379|"     Rural communities involved in agriculture are often at highest risk of insect-borne diseases     in Southeast (SE) Asia.      Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases     for those people working outdoors in high risk areas.      This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce     incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to     1000 households from 100 villages in rural Laos. In each house the investigators shall     recruit up to 5 individuals. Half of households will be randomised to repellent, half to a     placebo. All individuals will be provided with insecticide treated bed nets for use at night.     All household occupants will be followed for 7 months to record malaria cases by Rapid     Diagnostic Test every month. Blood spots will be collected at start and end of study to     measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated.     Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese     Encephalitis (secondary outcomes).   "
235450|NCT00938392|"     The objective of the study is to evaluate immunogenicity between different formulations of     GSK Biologicals' investigational vaccine GSK2186877A.   "
235506|NCT00939510|"     RATIONALE: Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the     tumor. GM-CSF may stimulate the immune system in different ways and stop tumor cells from     growing. Giving lenalidomide together with GM-CSF may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide     when given together with GM-CSF and to see how well it works in treating patients with     prostate cancer.   "
235451|NCT00938405|"     This is a prospective, randomized, double blind, parallel, placebo controlled clinical trial     evaluating the efficacy of colesevelam HCl in reducing LDL in subjects with type 1 diabetes     mellitus over a 12 week treatment period. The aim is to highlight the effect of colesevelam     on LDL cholesterol and glycemia in a type 1 diabetic population. The colesevelam group is     anticipated to demonstrate a mean reduction in LDL by 10% compared to the placebo group,     indicated by A1c and glycemic target range CGM readings.   "
235452|NCT00938418|"     Locally advanced non-small cell lung cancer can be treated successfully with chemotherapy and     radiation. However, the cure rate is low.      This study is carried out to find out whether giving radiotherapy at a higher dose over fewer     treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment     outcome.      This study aims to recruit 43 patients from National University Hospital and Tan Tock Seng     Hospital over a period of about 2 years.   "
235453|NCT00938431|"     The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in     children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to     3 other antiepileptic drugs (AEDs).   "
235454|NCT00938821|"     This is a chart review. The aim of this study is to investigate the effectiveness and side     effects of very low dose morphine administered caudally to children that went to surgical     procedures that used caudal anesthesia. The study compares caudal block with Bupivacaine (1     ml kg_1 of bupivacaine 0.25% and saline 0.02 ml kg_10) with very low dose morphine (a mix of     1 ml kg_-1 of ropivacaine 0.2% and preservative-free morphine: 10 µg kg-1).   "
235466|NCT00938977|"     Main objective:      To describe clinical and functional characteristics of the obese hypoventilating patient; to     study the relation between the obesity-hypoventilation syndrome (OHS) and the obstructive     sleep apnea hypopnea syndrome (OSAHS). In the second stage of the study, to assess patient     response to non-invasive mechanical ventilation (NIV) and continuous positive airway pressure     (CPAP), and to identify predictors of unfavourable response to treatment.      Methodology:        -  Patients: Patients with obesity degree I-III, with pCO2 awake and at rest > 45 mmHg,          with no underlying pulmonary or neuromuscular lung disease; two control groups, one of          non-hypoventilating obese patients and the other of obese patients with OSAHS, will also          be studied over the same period.        -  Design: Prospective observational study. In the first stage anthropometric, clinical,          functional and metabolic data will be recorded for the obese hypoventilating patients          and the two control groups (obese patients without respiratory pathology, and obese          patients with OSAHS).      In the second stage patients with OHS will be divided into two subgroups: group 1: patients     with polysomnography (PSG) suggestive of hypoventilation, in whom NIV treatment will be     initiated; group 2: patients with PSG suggestive of OSAHS (apnea-hypopnea index >15), who     will be administered CPAP. Patients will be examined one month and three months after the     start of treatment. The same measurements will be carried out as at the beginning of the     study, with the exception of the polysomnographic study. Nonetheless, pulse oximetry and     arterial gases will be performed on waking.      Expected Results:      Patients with OHS may be characterized and differentiated from obese patients without     associated respiratory pathology on the basis of clinical, functional and metabolic data.      There is a group of patients with association between OSAHS and OHS that do not respond to     treatment with CPAP, and this unfavorable response can be predicted in advance.   "
235455|NCT00938834|"     Fibromyalgia is a syndrome characterized by widespread musculoskeletal pain and hyperalgesia     with a prevalence of 2-4% in the general population; it is often accompanied by fatigue,     insomnia, anxiety, depression and other conditions. It is a difficult condition to treat, and     only recently have drugs been approved by the FDA specifically for the treatment of this     condition (Lyrica was approved in 2007, Duloxetine in 2008). There are now several clinical     trials of drugs commonly used to treat neuropathic pain (amitriptyline, gabapentin,     pregabalin, acetaminophen/tramadol, duloxetine, minserin) reporting some degree of efficacy     in treating fibromyalgia. This efficacy makes it practical to consider fibromyalgia along     with other neuropathic pain conditions. However, such drug trials report only partial     efficacy in relieving pain and/or other symptoms. Current treatment recommendations indicate     the need for a multimodal approach; this includes medical management using appropriate drug     therapies, psychological therapies, exercise and complementary approaches. The current     proposal is for a randomized controlled trial to compare qigong (a complementary modality) to     a wait list control to determine if qigong is a useful complementary therapy for     fibromyalgia.      The investigators recently completed a pilot trial in which they examined a specific form of     qigong (CFQ Qigong, available locally in Halifax), and observed beneficial effects against     pain, fibromyalgia impact, and on quality of life scores; importantly, these benefits were     all sustained for 6 months to the end of the trial. On the basis of these preliminary     observations, the investigators now propose a controlled trial in which CFQ Qigong is     compared to a wait list control group. The latter group will be offered qigong training at     the end of the trial, so could really be characterized as a delayed treatment group. The     study will consist of a 3-day training period, weekly review of technique sessions for 8     weeks, daily practice for 8 weeks, with assessments at baseline, at 8 weeks following the     training and practice, and follow-up assessments at 4 and 6 months. Study outcomes will     include: (a) pain (numeric rating scale - pain intensity), (b) impact (fibromyalgia impact     questionnaire), (c) quality of life measures (SF-36), (d) patient assessments (patient global     impression of change and satisfaction scales), (e) sleep measures (Pittsburgh sleep quality     index, actigraphy, sleep diary). In addition to these assessments, the investigators will     also conduct qualitative assessments in which participants provide a more open-ended     assessment of their health status at these same intervals. The main hypothesis being examined     is that CFQ Qigong will produce benefits compared to the wait list group.   "
235456|NCT00938847|"     Evaluative pilot study for safety and feasibility with administration of autologous bone bone     marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo     the ischemic lesion.   "
235457|NCT00938860|"     This study will assess the rates of Sustained Virological Response following anti-viral     therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with     recurrent Hepatitis C and treated with Neoral or tacrolimus.   "
235458|NCT00938873|"     Mindfulness based cognitive therapy (MBCT) is a group psycho-educational treatment designed     to reduce the risk of recurrent depression by integrating mindfulness based meditation     practices with cognitive therapy techniques. MBCT comprises eight weekly two-hour group     sessions. Additionally, participants are required to commit to one hour per day of between     sessions meditative homework assignments six days per week. Existing quantitative research     suggest that MBCT is an effective intervention for preventing depressive relapse in patients     with three or more episodes of depression (Teasdale et al.2000, Ma & Teasdale, 2004). The     focus of qualitative research has been on evaluating the acceptability of MBCT for various     clinical populations; participants' accounts have been positive indicating MBCT may be a     potential therapeutic tool for treating older adults (Graham & Senthinathan, 2007), psychosis     (Abba, Chadwick, & Stevenson, 2008), Parkinson's disease (Fitzpatrick, Simpson, & Smith,     2010) as well as acute depression (Mason & Hargreaves, 2001).      The benefits of undertaking meditative mindfulness practice in the context of MBCT have been     linked to changes in metacognitive processes. Two distinct multi-level information processing     frameworks dealing with how thoughts are processed from a metacognitive perspective have been     proposed: The Interacting Cognitive Subsystems (ICS; Teasdale, 1999a, 1999b) and the Self     Regulatory Executive Function (S-REF; Wells, 2000) theory. The ICS framework forms a     rationale for meditative aspects of the MBCT programme. The S-REF model differs from the ICS     theory in its conceptualisation of the object or 'being' mode of metacognitive processing.      Regular daily practice of mindfulness meditation has been regarded as among the most     essential aspects of mindfulness programmes (Kabat-Zinn, 1990; Mason & Hargreaves, 2001).     Existing studies, with their focus on effectiveness or acceptability of MBCT as an     intervention, have thus far excluded an important aspect of the course involving the     experience of meditative homework assignments. Therefore, the aim of this study was to     explore subjective accounts of the meaning of carrying out meditative homework assignments in     the context of a National Health Service (NHS) run MBCT course. The research questions     focused on the impact of meditative homework on thought processes as well as an exploration     of barriers and facilitating factors from a participant's perspective.Six individual in-depth     interviews were conducted with participants all of whom had completed the full MBCT     programme. Interpretive phenomenological Analysis (IPA) was used as the methodology for     analysing interview transcripts. Data analysis began with a detailed examination of one case     until a thorough analysis was completed after which subsequent cases were analysed. Finally a     cross case analysis was carried out where individual themes were interrogated for     similarities and differences (Smith, et al., 2009).      Two master themes were presented: 'The relationship of meditative homework to metacognitive     experience' and 'Motivating and discouraging factors for engagement in meditative practice'.     Results reveal a transformation in metacognitive processes as a result of undertaking     meditative homework. The subjective experience of metacognitive processes is examined in the     context of existing psychological theories including the ICS (Teasdale, 1999a, 1999b) as well     as the S-REF (Wells, 2000) theory involving metacognitions. A model for perceived     facilitating factors and difficulties experienced in carrying out meditative homework is     constructed based on the Integrated Theoretical Foundations Model for CBT homework assignment     (Kazantzis, et al., 2005). The model explores participants' motivation in three stages of the     homework process: firstly during assignment of the meditative homework task, secondly in     completing the planned task and finally carrying out review of the task in question.     Implications of the present study are discussed in relation to psychological literature,     homework assignment and the practise of MBCT.   "
235459|NCT00938886|"     To test whether naltrexone compared to placebo can reduce heavy drinking and improve smoking     cessation outcomes in heavy drinkers seeking smoking cessation treatment.   "
235460|NCT00938899|"     The purpose of this study is to examine the safety, tolerability and pharmacokinetics of     increasing oral doses of TMC435350 after single and repeated dosing, followed by an open     label repeated dosing session in 6 HCV genotype1 infected patients.   "
235461|NCT00938912|"     SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in     children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as     adjunctive therapy.   "
235462|NCT00938925|"     Onychomycosis occurs in more than 50% of all pathologies unguinal, affecting the health and     quality of life of the patient. Although the investigators have a wide therapeutic arsenal,     there is still a disparity when carrying out an effective processing.      Hypothesis/Objectives:      To analyze if the use of the podiatric technique of aggressive unguinal abrasion with     micrometer sports, in combination with topical treatment with amorolfin 5% in hairspray,     significantly increases the effectiveness clinically as well as mycology.      The investigators will analyze the relationship between this intervention and the quality     perception of life related to the health of the nails and the foot.      The investigators will Use results for next validation study in Spanish of the questionnaire     NailQoL, as well as validation and reliability of the index SCIO and cost study-effectiveness     of the processing.      Method:      The investigators will design a randomized control trial. The town will be recruited,     informed prior consent will be obtained from patients of 5 Spanish centers of chiropody, with     sample size of 313 patients. There will be a screening of 4 weeks to select patients with     onychomycosis infections (clinic and mycology both positives); later the patients will be     distributed randomly in 2 groups:        -  GROUP AM+AU: Will be administered aggressive unguinal abrasion, weeks 0 (baseline), 12          and 24, followed by standard treatment of amorolfin 5%, two weekly applications during          36 weeks.        -  GROUP AM: Will be administered exclusively standard treatment of amorolfin 5%, according          to common format. The duration will be 48 weeks.   "
235463|NCT00938938|"     The purpose of this study is to test the effect of adding a press guide to standard     materials that journalists routinely receive regarding research published in medical     journals.   "
235464|NCT00938951|"     The primary objective of this study is to compare visual degradation in a stressed (forced     stare) environment in patients before and after acute administration of Systane Ultra.   "
235507|NCT00939523|"     PURPOSE      The drug Lapatinib has been shown to inhibit both epidermal growth factor receptor (EGFR) and     erbB2 tyrosine kinases resulting in an effective slowing of disease progression in breast     cancer. It has also been demonstrated that erbB is overexpressed in human pituitary adenomas.     The investigators are therefore assessing tumor size stabilization and pituitary tumor     secretory profiles during the course of a six month therapy of lapatinib. The purpose of this     trial will be to estimate the activity of lapatinib in slowing the growth rate of pituitary     tumors. Lapatinib is an FDA approved drug used to treat breast cancer. However, in this     study, the drug will be used to treat pituitary cancer.      STUDY POPULATION      This study will recruit patients from the Pituitary Center at CSMC who are over the age of 18     that have a recurrent nonfunctioning adenoma after at least one surgical resection as well as     patients with prolactinomas who are resistant to dopamine agonist therapy and patients with     recurrent Cushing's disease.      PARTICIPANT'S JOURNEY THROUGH THE RESEARCH      The principal investigator (PI) or co-investigator will determine patients' potential     eligibility for the study based on inclusion and exclusion criteria.      The PI or the co-investigator will then approach subjects with recurrent nonfunctioning     adenomas or prolactinomas resistant to dopamine agonist therapy or recurrent Cushing's     disease during a visit in the clinic office and ask if these subjects would be interested in     participating in this study. If the subjects express interest, they will be given the consent     form to review. They will be encouraged to review it with family, friends, and/or other     physicians. The PI, co-investigators, or research nurse will be available for any questions     the subjects might have. If the subjects are still interested, they will be asked to sign and     return the consent form to the office and a study visit will be scheduled.      The PI, co-investigator, or member of study staff may also attempt to contact current     patients by phone to assess interest in participating in the study. The purpose and overall     structure of the study will be discussed with the possible participant. They will be reminded     that the study is strictly voluntary and that their involvement or disinterest in the study     will not affect their ongoing care. If the patient is interested they will be mailed a     consent to review and will be asked to call the center to schedule an appointment to further     discuss the study if they decide they are interested.      Each participant will undergo 8 visits of the course of the study. Each participant will have     a baseline visit where a medical history will be taken, a physical, visual field test,     electrocardiogram (ECG), echocardiogram (ECHO), and blood draw will be performed. At this     point lapatinib therapy will begin and the patients will be asked to take the drug daily for     the next six months. Patients will take Lapatinib 1250 mg daily (orally), which is the     standardized dose used to treat breast cancer patients. Visit 2 will be 1 month after the     participant has started lapatinib. At visit 2 all participants will receive a physical exam,     a history will be taken, an ECG will be performed, and a blood draw will occur. Visit 3 will     be 2 months after starting lapatinib. A physical exam and history will be performed along     with an ECG and echocardiogram and blood draw. Visit 4 will be 3 months after starting     lapatinib. A physical, history, blood draw, ECG, visual field test, and a magnetic resonance     imaging (MRI) of the pituitary will be performed. Visit 5 will occur 4 months after starting     lapatinib. A physical exam and history along with a blood draw and ECG and echocardiogram     will occur. Visit 6 will be 5 months after starting lapatinib. A physical exam, history, ECG,     and a blood draw will occur. Visit 7 will occur 6 months after the start of lapatinib. A     physical exam, history, blood draw, visual field test, ECG, echocardiogram and MRI of the     pituitary will occur. At this point lapatinib will be discontinued. Visit 8 will occur 1     month after visit 7 and a physical exam, history, blood draw, and ECG and and echocardiogram     will occur.   "
238047|NCT00973284|"     The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle     (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during     the inpatient stay.   "
235465|NCT00938964|"     The purpose of this study is to see if a drug called lidocaine prevents cognitive injury (a     decline in mental abilities) after heart surgery. Lidocaine is currently FDA approved and is     commonly used for treating some heart rhythm disorders and for regional anesthesia (blocking     nerves). The investigators are enrolling subjects in this research project to see if     lidocaine will reduce the high incidence of cognitive injury seen after heart surgery. As     part of this study, the investigators will also evaluate the relationship between cognitive     injury and genetic makeup and the chemical changes in the subjects blood during and after     surgery.   "
235483|NCT00939198|"     Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life     cycle. In a clinical study in previously hookworm-infected adults in Brazil, this protein     induced urticarial reactions (rash) in a subset of volunteers. The clinical trial component     of this study involves skin testing for immediate-type hypersensitivity to the Na-ASP-2     Antigen. Both prick-puncture and intradermal tests will be applied.   "
235497|NCT00939393|"     Endoscopic sinus surgery will be performed either in the physician's office or in the     operating room (OR). Patients treated in the physician's office will have endoscopic sinus     surgery performed with balloon sinuplasty devices. Patients treated in the OR will have     endoscopic sinus surgery performed with or without balloon sinuplasty devices.   "
235744|NCT00934440|"     To identify the maximum tolerable dose and assess qualitative/quantitative toxicities in     patients with advanced renal cell cancer treated with combination of 5-azacitidine and     bevacizumab.   "
235467|NCT00938990|"     Rationale: The drug etomidate causes increased mortality if used for continuous sedation in     mechanically ventilated patients; however, etomidate continues to be widely used as a     single-bolus induction agent for endotracheal intubation because of its favorable hemodynamic     properties. Recent data have raised questions regarding the safety of using etomidate for     even a single bolus in patients at risk of adrenal insufficiency, emphasizing the fact that     single bolus doses of etomidate cause measurable adrenal suppression, and consequently may     cause increases in vasopressor requirements and in hospital length of stay. Alternative     FDA-approved induction agents, such as midazolam, may be safer than etomidate; however, no     studies have formally compared these agents.      Research Hypothesis: The investigators hypothesize that in critically ill trauma patients     presenting to the emergency department requiring rapid sequence intubation, the hospital     length of stay for patients given etomidate will be greater than for patients given midazolam     for induction.      Specific Aims: The specific aim is to determine the difference in hospital length of stay     between trauma patients given etomidate and those given midazolam for induction during rapid     sequence intubation in the emergency department. The investigators plan to compare the two     groups in terms of hospital length of hospital stay, length of stay in the intensive care     unit, and duration of intubation by performing a prospective, randomized, trial of critically     ill trauma patients presenting to the emergency department requiring intubation. The     investigators will also compare the mortality rates in these two groups while controlling for     severity of illness and the use of steroids while hospitalized.      Significance: If the use of etomidate to induce anesthesia prior to intubation adversely     affects the hospital length of stay of trauma patients, this length of stay might be reduced     in such patients by using alternative agents for induction. Since etomidate is currently in     widespread use as an induction agent, the results of this study could have significant     implications for patient management.   "
235468|NCT00939003|"     This study will evaluate how well adalimumab works in the short and long term in patients     with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or     psoriatic arthritis.   "
235469|NCT00939016|"     The purpose of this study is to evaluate the influence of dietary restraint, social     desirability, and food type on the accuracy of dietary intake reported during a 24-hour     recall.   "
235470|NCT00939029|"     Smokeless tobacco use (chewing) is associated with negative health effects. To date, no     medications have been shown to help chewers quit long-term. High dose nicotine patch therapy     may improve the chances that chewers can quit for good. If found to be effective, chewers may     use this treatment to help them quit and reduce their risk for negative health effects.   "
235471|NCT00939042|"     Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy     concerning left ventricular ejection fraction as measured by echocardiography.   "
235472|NCT00939055|"     The Roux-en-Y gastric bypass (RNYGB) is a weight loss surgery that involves the creation of a     small gastric pouch and rearrangement of the small intestine. Although RNYGB has been     demonstrated as an effective bariatric procedure, a significant number of patients experience     weight regain that is often associated with distended gastric anatomy. Open and laparoscopic     approaches for revision are associated with higher complication rates than de novo     procedures. This study will evaluate the safety and effectiveness of a revisional     incisionless natural orifice surgery of the gastric pouch and stoma in producing weight loss     in post-RNYGB patients who have experienced weight regain.   "
235473|NCT00939068|"     The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy     for the prevention of HBV perinatal transmission in highly viraemic mothers.   "
235474|NCT00939081|"     The purpose of this study is to examine whether pedometer step count recommendations (10,000     steps/day versus an adaptive recommendation) are differentially associated with the primary     outcome of adherence to the pedometer-based physical activity regimen and the secondary     outcomes of change in physical activity and body mass index (BMI).   "
235475|NCT00939094|"     The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to     placebo can relieve the pain arising from the nervous system when the patients are touched by     something that should not cause pain or have severe pain when they are touched by something     that should only cause a little pain.   "
235476|NCT00939107|"     Introduction:      The McKenzie method as well as spinal manipulation is commonly used for the treatment of low     back pain throughout the western world. Recently, the need for studies testing the effect of     treatment strategies to specific diagnostic subgroups of patients has been emphasized. The     present study aims to compare the effectiveness of the McKenzie method and chiropractic     manipulation, information, and advice for patients with clinical signs of persistent symptoms     originating from a diskus in the low back.      Methods:      After clinical screening 350 patients with or without leg pain who presented with     centralization of symptoms or signs of disc herniation were randomized to the McKenzie group     or the manipulation group. The outcome measures, Roland Morris Disability Questionnaire, 11     point numerical pain scale, 6 point global perceived change scale, and quality of life (Short     Form-36) were assessed at baseline, at end of treatment, and at 2 and 12 months follow-up.   "
235477|NCT00939120|"     This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride     given for 18 months, including a 1-year double-blind randomized co-administration with either     tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS) including     urgency and frequency, with or without urgency urinary incontinence (i.e., overactive bladder     (OAB) symptoms).   "
235478|NCT00939133|"     The use of topical retinoids is a mainstay and basis of early acne treatment to prevent the     progression to inflammatory lesions. Post oral isotretinoin, it is not uncommon for     non-inflammatory papules and comedones to recur. However, there has been no formal study to     look at the prevention of recurrence of these acne lesions post isotretinoin in a long term     basis. This may enhance the therapeutic options for post isotretinoin patients in order to     prevent recurrence of their disease.      Hypothesis Tretinoin microsphere 0.04% will prevent recurrence of acne lesions.   "
235479|NCT00939146|"     This study will demonstrate whether an end-of-life preparation and completion intervention     reduces anxiety, depression, pain and other symptoms and improves functional status,     spiritual well-being, and quality of life. If effective, the intervention offers a brief,     inexpensive, and transportable non-physician treatment method for improving the experience of     individuals in the latter stages of life-limiting illness.   "
235480|NCT00939159|"     The goal of this clinical research study is to learn if LBH589 can help to control lower-risk     (low or intermediate-1 risk) MDS. The safety of this drug will also be studied.   "
235481|NCT00939172|"     The goal of this clinical research study is to find the highest tolerable dose of TTP607 that     can be given to patients with a solid tumor or lymphoma. The safety of TTP607 will also be     studied.      Researchers will also do pharmacokinetic (PK) testing of TTP607. PK testing measures the     amount of a drug in the body at different time points.   "
235482|NCT00939185|"     The objective of this study was to obtain data on the safety, tolerability and compliance     with Zithromax in children with bacterial infections of the upper and lower respiratory     tract.   "
235484|NCT00939211|"     Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with     deteriorating lung function over the years. Patients with COPD experience symptoms of     shortness of breath, cough and sputum production. This study is to assess the treatment     effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg)     and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator.     25 patients are to participate in the study and all will be recruited in Sweden. Each patient     will visit the study doctor 9 times during the study, whereof 5 visits will be overnight     visits. All examinations, treatment and the follow-up is free of charge.   "
235485|NCT00939224|"     The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device     to measure regional oxygen saturation in a cohort of children with cardiovascular disease     undergoing cardiac catheterization.   "
235486|NCT00939237|"     The purpose of this study is to determine whether Ateronon, a nutritional supplement that     contains lycopene from tomatoes has a favorable effect on carotid atherosclerosis, lipid     levels, and other biomarkers of coronary heart disease.      The trial was stopped early due to insufficient financial support from the initial study     collaborator, Cambridge Theranostics Ltd. Collected patient data are sufficient for final     trial-based analyses to be conducted with financial support from the new study collaborator,     CamNutra Ltd. The data will still be analyzed according to the original study aims.   "
235487|NCT00939250|"     The study involves a 32-week randomized controlled trial in primary care of a comprehensive     diabetic and depression intervention in patients with type 2 diabetes and comorbid MDD,     compared to a group treated with usual care for MDD plus disease self-management and     measurement-based care for diabetes.   "
235488|NCT00939263|"     Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease of the esophagus affecting     children and adults. The most frequent symptoms are swallowing difficulties and thoracic     pain. The disease has first been described in the 1980s and is found with rapidly increasing     frequency mainly in industrialized countries. The factors that lead to EoE are until now     incompletely understood, of importance, the disease is found more frequently in men and     patients suffering from allergic diseases (e.g., Asthma). So far there exists no activity     index to define the severity of EoE; such an index is urgently needed for future clinical     trials to determine the efficacy of current and future therapies. The investigators' 3-year     project, carried out in cooperation with international EoE experts, aims at the development     of an activity index for adult and pediatric EoE patients that will be used in future     clinical trials as well as observational studies.   "
235489|NCT00939276|"     The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who     developed macular edema (ME) within 90 days following cataract surgery.   "
235490|NCT00939289|"     The purpose of this pilot study is to evaluate performance of the SEVEN System and the     Navigator System when both devices are worn concurrently by subjects with type 1 diabetes     mellitus.   "
235491|NCT00939315|"     The aim of this study is to establish the diagnostic value of     O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) PET-CT, [18F]-fluorocholine (FCH) and magnetic     resonance imaging (MRI) combined with magnetic resonance spectroscopy (MRS) in patients with     suspected cerebral glioma using neuronavigated biopsies with histopathological analysis as     reference.   "
235492|NCT00939328|"     RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways.     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help     kill them or carry cell-killing substances to them. Giving bendamustine together with     rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects of giving bendamustine together     with rituximab and to see how well it works in treating patients with B-cell chronic     lymphocytic leukemia that has not responded to previous treatment.   "
235493|NCT00939341|"     The purpose of this study is to compare whether Symbicort Maintenance & Reliever Therapy     (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a     real life situation.   "
235556|NCT00940160|"     This study is designed to investigate the safety and tolerability of multiple doses of QAX576     in controlled or partially controlled asthma patients.   "
235495|NCT00939367|"     -  Objective:             -  To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test               Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited,               India Reference Product: Ambien® Tablets 10 mg (Reference Listed Drug) manufactured               by Sanofi- Synthelabo Inc. under fed conditions in 30 healthy, adult, human               subjects in a randomized crossover study.        -  Study Design:             -  Open label, randomized, two-period, two-treatment, two-sequence single dose               crossover design.   "
235496|NCT00939380|"     The investigators have developed a parent social-cognitive processing intervention (P-SCIP)     to help decrease distress among parent caregivers of children undergoing hematopoietic stem     cell transplant (HSCT). The investigators will evaluate the efficacy of P-SCIP in reducing     short- and long-term distress and parenting stress among 300 parents of children undergoing     HSCT. P-SCIP will be delivered during the child's inpatient HSCT hospitalization and is     specifically designed to improve parent social (e.g., sharing concerns) and cognitive (e.g.,     acceptance) processing of the transplant experience. The intervention includes five in-person     sessions that are accompanied by an interactive CD-ROM. The CD-ROM complements the materials     in the in-person sessions and provides parents with the opportunity to enhance and deepen     their cognitive and social processing of the HSCT experience. The intervention will be tested     against best-practices psychosocial care (BPC) available in four enriched pediatric HSCT     settings across the United States. P-SCIP will be provided to both Spanish- and     English-speaking parents. Participants will complete measures of psychological distress,     well-being, and social and cognitive processing at the time of HSCT, two, six and twelve     months after HSCT. Research questions will address the effects of P-SCIP versus BPC on parent     psychological adaptation and social and cognitive processing, as well as evaluate parent     personal resources as well as child medical course variables that contribute to intervention     response. The investigators will also examine barriers to participation in the intervention     by comparing barriers to participation among parents who refuse participation in the trial     and parents who accept.   "
235498|NCT00939406|"     The aim of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients     undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk     herniation. The device is used as an adjunct in lumbar spine surgery to prevent post-     surgical fibrosis and adhesions, and improve patient outcomes.   "
235499|NCT00939419|"     The purpose of the study is whether the provision of tuberculosis care using volunteer     community health workers or self-administered treatment for 7 months is equally effective     with the existing 8 months of TB care in public health facilities by health workers. Patient     care by volunteer community health workers and 7 months of self-administered treatment are     more patient-convenient delivery options than the ongoing TB care in health facility.   "
235500|NCT00939432|"     Objective/study hypothesis To evaluate how much of a taboo UI is and how it compares to other     medical conditions that may also pose a taboo issue like depression and cancer.      Background Urinary incontinence (UI) is a highly prevalent condition with more than 200     million people worldwide being affected. While physical health does not necessarily have to     be impaired much, restriction of social activities leads to isolation, a significant     reduction in quality of life and will often bring about subsequent morbidity. Despite its     prevalence, many patients suffering from UI go undiagnosed and untreated. Patients often     hesitate to report the problem, and health care professionals often do not ask about it. In a     study Minassian (2003) estimated that just one in four patients actively seeks medical     attention. The reason for this may lie in the shame, embarrassment, and stigma associated     with this condition, which in turn pose significant barriers to seeking professional     treatment. Although mentioned by many narrative reviews and included in some epidemiological     papers on UI, surprisingly we found no data addressing the taboo of UI exclusively. The aim     of our study therefore was      Methods/Design A 13-question self-administered questionnaire was developed and face validity     tested by 2 of the authors (KH, EH). The anonymous questionnaire contained simple questions     on gender and age and then asked yes/no questions on whether test persons knew people with     UI, or suspected other people to be incontinent, if they would address this issue with the     suspected person, and if they thought that UI was a taboo issue in the society. On a scale     from 0 - 10 they were then asked to grade the amount of embarrassment and anxiety if they     themselves were incontinent, compared to depression or cancer. A few questions on knowledge     of the condition of UI and to whom test persons would turn to in case of UI concluded the     short questionnaire, which took about 5 minutes to fill in. A convenience sample of 150 test     persons from waiting areas of a teaching hospital and in private practices of general     practitioners in Austria agreed to take part in the study, with an additional 10 persons     (6.2%) declining after being informed about the subject. Data were analysed with the SPSS     10.0.5 software package using the U-test, Chi-square-test, Yates-correction, Fisher's exact     test and Kolmogorov-Smirnov normality test where appropriate.   "
235501|NCT00939445|"     1. To compare the efficacy of        1. Short Daily Hemodialysis        2. Online HDF in term of adequacy of dialysis.   "
235502|NCT00939458|"     -  Objective:             -  To assess the bioequivalence of Lamotrigine 2 x 25 mg IR tablets of Torrent               Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of               Glaxo-SmithKline, USA, in healthy human adult subjects, under fed conditions.        -  Study Design:             -  A randomized, open label, two treatment, two period, two sequence, single dose,               crossover study, under fed conditions.   "
235503|NCT00939471|"     A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety     and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis     following failed medical management.   "
235504|NCT00939484|"     This phase II trial is studying how well vismodegib works in treating adult patients with     recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells and     may be an effective treatment for medulloblastoma.   "
235505|NCT00939497|"     Objective:        -  To assess the bioequivalence of Risperidone 1.0 mg tablets of Torrent Pharmaceuticals          Limited., India and Risperdal® (Risperidone) 1.0 mg tablets of Janssen Pharmaceutical          Products, LP, USA, in healthy human adult subjects, under fasting conditions.      Study Design:        -  A randomized, open label, two treatment, two period, two sequence, single dose,          crossover study, under fasting conditions.   "
235557|NCT00940173|"     The purpose of this study is to establish the safety of xenotransplantation of     DIABECELL(R)[immunoprotected (alginate-encapsulated) porcine islets] in patients with     established type 1 diabetes mellitus, and to establish preliminary evidence of the efficacy     of DIABECELL(R), as measured by a reduction in serial hemoglobin A1c (HbA1C) levels.   "
235508|NCT00939536|"     -  Objective:             -  To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test               Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited,               India Reference Product: Ambien® Tablets 10 mg (Reference Listed Drug) manufactured               by Sanofi- Synthelabo Inc. under fasting conditions in 24 healthy, adult, human               subjects.        -  Study Design:             -  Open label, randomized, two-period, two-treatment, two-sequence single dose               crossover design.   "
235509|NCT00939549|"     The purpose of this study is to determine if high-dose cyclophosphamide followed by a     maintenance dose of glatiramer acetate is safe in patients with relapsing remitting multiple     sclerosis (MS). The investigators hypothesize that institution of glatiramer acetate     treatment following high-dose cyclophosphamide treatment will extend the period of disease     free activity and further reduce the disability in patients with relapsing remitting multiple     sclerosis. The investigators plan to investigate the properties of glatiramer acetate against     the recurrence of MS disease activity following high dose cyclophosphamide induced cessation     detectable autoimmunity. The investigators hypothesize that glatiramer acetate, given in the     phase of immune reconstitution after high-dose cyclophosphamide, may bias the immune system     to a more tolerated state, thus leading to more stable and potentially permanent remissions.   "
235510|NCT00939562|"     The purpose of this protocol is to study if two different tablet formulations of doxycycline     are bioequivalent to each other.   "
235519|NCT00939679|"     The purpose of this study is to investigate the short term and long term effects of Roux-en-Y     gastric bypass (RYGB) surgery on energy expenditure, gastrointestinal and appetite regulating     hormone levels, and appetite sensation. We hypothesize that following RYGB surgery,     metabolism will be elevated in comparison to patients who have not yet had RYGB but who are     losing weight simultaneously using a low calorie diet. We further hypothesize that this     higher metabolism will be associated with alterations in fasting and postmeal levels of     gastrointestinal and appetite regulating hormones. Long term (1.5 years after RYGB), we     hypothesize that differences in metabolism, body composition, and hormone levels will     distinguish between patients who have maintained their weight loss after RYGB vs those who     have regained weight.   "
235511|NCT00939575|"     The hypertensive disorders of pregnancy are the medical complications more prevalent during     pregnancy. In Canada, approximately 1% of pregnancies have complications due to a     pre-existing hypertension, 5-6% because of hypertension of pregnancy without proteinuria and     1-2% by preeclampsia. Metabolomics involves a new technology to investigate small molecules     that characterize biochemical pathways of interest. The change in concentration levels of     these molecules in various biological samples such as urine and blood in the presence of a     disease or a patient can be particularly useful for identifying new biomarkers. Our     hypothesis is that metabolic patterns in blood and urine of pregnant women who had     preeclampsia differ from the metabolomics patterns of patients without preeclampsia.The whole     research program has two complementary objectives in order to expect a decrease of     prematurity: a) better understanding of all the physiological mechanisms leading to     prematurity and b) better identification of patients at high risk for a better management of     these women.   "
235512|NCT00939588|"     This study is designed as a mechanistic study to compare the effect of two different     combinations of anti-hypertensive treatments (aliskiren and valsartan vs. telmisartan and     ramipril) on the renin-angiotensin-aldosterone system (RAAS) in patients with moderate     hypertension.   "
235513|NCT00939601|"     Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops     breathing or experiences shallow breathing for short periods of time during sleep. The most     common treatment for OSA is the use of a continuous positive airway pressure (CPAP) machine,     but many people have trouble adhering to the treatment schedule. This study will evaluate the     effectiveness of two behavioral therapy programs used in combination with CPAP for improving     treatment adherence in people with OSA.   "
235514|NCT00939614|"     -  Objective:             -  A randomized, open label, two treatment, two period, two sequence, single dose,               crossover, bioequivalence study of Lamotrigine 2 x 25mg IR tablets of Torrent               Pharmaceuticals Limited, India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of               Glaxo-SmithKline, USA, in healthy human adult subjects, under fasting conditions.        -  Study Design:             -  Randomized, open label, two treatment, two period, two sequence, single dose,               crossover, in 24+2 healthy human adult subjects to compare the single dose               bioavailability of Torrent's Lamotrigine Tablets 2 × 25 mg and Lamictal® Tablets 2               × 25 mg of GlaxoSmithKline. Dosing periods were separated by a washout period of at               least 21 days.   "
235515|NCT00939627|"     Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow     to the tumor. It is not yet known whether cetuximab is more effective when given alone or     together with sorafenib tosylate in treating patients with head and neck cancer. This     randomized phase II trial is studying cetuximab to see how well it works when given together     with or without sorafenib tosylate in treating patients with refractory, recurrent, and/or     metastatic head and neck cancer.   "
235516|NCT00939640|"     Heart failure with preserved systolic function (HF-PSF, or 'diastolic heart failure')     accounts for half of hospitalizations for heart failure in patients over the age of 65. Most     HF-PSF patients have systemic hypertension (HTN), and characteristic HTN-induced     cardiovascular changes contribute to HF-PSF. However, it is unclear why most patients with     HTN never develop HF-PSF or which specific aspects of HTN predispose to HF-PSF.      In the Dahl S rat, the primary animal model of HF-PSF, high dietary sodium intake suppresses     the systemic renin-angiotensin-aldosterone system, but upregulates renal and cardiac     renin-angiotensin-aldosterone system by inducing oxidative stress. In humans, the magnitude     of blood pressure response to sodium ingestion and depletion can categorize subjects as     salt-resistant and salt-sensitive. Human salt sensitivity is associated with structural     and loading conditions that increase the risk for HF-PSF, including HTN, ventricular     hypertrophy and diastolic dysfunction, arterial stiffening, and increased plasma volume. High     dietary sodium intake induces oxidative stress in salt-sensitive humans. In humans with HTN     and normal ventricular systolic function that do not have heart failure, increased oxidative     stress predicts impaired exercise capacity, ventricular hypertrophy, diastolic dysfunction,     arterial stiffening, and vascular endothelial dysfunction. The investigators have proposed     that salt sensitivity and the accompanying oxidative stress on the typical high-sodium     Western diet may contribute to the initiation and progression of HF-PSF.      In patients with HF-PSF, the investigators will relate dietary changes to biochemical and     cardiovascular functional measures. The investigators will study subjects on ad-lib diet and     and following three weeks of rigorous dietary modification with the Dietary Approaches to     Stop Hypertension (DASH)/sodium-restricted diet (SRD). This diet is richer in natural     antioxidants and lower in sodium than the usual American diet. The DASH/SRD is recommended to     lower blood pressure in patients with HTN, and is particularly effective in elderly, obese,     and salt-sensitive hypertensives. Dietary sodium restriction is recommended for all HF     patients including those with HF-PSF. The investigators hypothesize that the DASH/SRD will     have favorable effects on oxidative stress, ventricular and vascular function, and blood     pressure control in patients with hypertensive HF-PSF.   "
235517|NCT00939653|"     Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating     children (age 1-21) with leukemia. This research study will use clofarabine with two other     cancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16) and     cyclophosphamide (Cytoxan®).      Clofarabine, etoposide and cyclophosphamide have been used together in a phase I study to     find out the highest doses of these drugs that can be safely given to children with relapsed     or refractory leukemia. This study is a phase II study which will use the drugs to study how     well these drugs work against AML. This study will also examine the safety of this drug     combination.   "
235518|NCT00939666|"     The high proportion of complete and good responders with modern chemoradiation and the     improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest     to the question whether in patients with complete or good response the overall benefits of a     'wait-and-see policy' or transanal endoscopic microsurgery (TEM) combined with intensive     follow-up may outweigh the benefits associated with conventional surgery (total mesorectal     excision (TME)or abdominoperineal resection (APR)). On the one hand, less invasive strategies     will expose subjects to more diagnostic procedures and possibly a slightly higher risk of     local failure and the need for salvage surgery. On the other hand, mortality and morbidity     associated with radical surgery (e.g. anastomotic leakage, relaparotomy, wound and pelvic     infection, chronic wound healing disturbances, abscess, colostomy, faecal or urinary     incontinence and sexual dysfunction) can be avoided. The investigators believe that     wait-and-see policy for complete responders and TEM for good responders after chemoradiation     is a feasible alternative to standard surgery, provided these patients are intensively     followed.   "
235533|NCT00939861|"     Study hypothesis: equivalency of laparoscopic compared to laparotomic colorectal resection     for endometriosis on digestive, gynaecologic, general symptoms and quality of life. Morbidity     and fertility outcomes will also be evaluated.Primary purpose of the protocol is the     evaluation of dyschesia.   "
235520|NCT00939692|"     -  Objective:             -  Compare the bioequivalence of a test topiramate formulation (Torrent               Pharmaceuticals Limited) to an equivalent oral dose of the commercially available               topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26               adult subjects under fasted conditions.        -  Clinical Design:             -  Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human               adult subjects.   "
235521|NCT00939705|"     -  Objective:             -  Compare the bioequivalence of a test topiramate formulation (Torrent               Pharmaceuticals Limited) to an equivalent oral dose of the commercially available               topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of adult               subjects under fed conditions.        -  Clinical Design:             -  Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human               adult subjects.   "
235522|NCT00939718|"     While treating depression, significant numbers respond poorly to anti-depressants; one cause     is vitamin B12 deficiency. The investigators are conducting an open label randomized     controlled trial to investigate difference in response to SSRI monotherapy alone versus SSRI     and intramuscular B12 replacement in people with low-normal B12 levels. 300 participants will     be allocated to each arm of intervention at out patient clinics of the department of     Psychiatry at Aga Khan University Hospital, Karachi Pakistan. Baseline and 3 month     measurement of depression will be on Hamilton Rating Scale for Depression (Urdu version) and     response rates compared.   "
235523|NCT00939731|"     The study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over,     single-dose study employing administration of two PF-02341066 formulations in the fasted     state to healthy adult volunteers.   "
235524|NCT00939744|"     Recent studies show that EET and 20-HETE have important biological effects, particularly in     the vascular system. The investigators studied the effect of eicosanoids on the gravid rat     uterus. The results suggest that 20-HETE had an tocolytics effect on gravid uterus. In the     previous study, we demonstrated that the enzymes of the pathway of EET were present in human     uterine tissues. Moreover, the addition of an inhibitor of degradation of EET had an     tocolytic effect on the human myometrium, as the exogenous addition of 8.9, 14,15-EET and     20-HETE.      Objectives:      Primary objective: To compare the balance of different metabolic pathways of arachidonic acid     (AA) of the pregnant human myometrium in pathological situations (preterm labor, uterine     atony, prolonged pregnancy).      Specific objectives: i) To study the effect of derived from the AA on in vitro contractile     activity of normal and pathological uterine tissues, and ii) detect and quantify the     different sub-products of metabolism of AA in the uterine tissues (myometrium, fetal     membranes and placenta).      The management of uterine contraction is in the heart of modern obstetrics year, yet the     progress made in other specialties, based on the study of smooth muscle have not yet been     transposed in obstetrics. A better understanding of systems for regulating the contraction is     important in terms of 1) new physiological knowledge, but it could also be the source of 2)     modification of strategies to take care of premature delivery (new Tocolytic), or 3)     improving the efficiency of uterine muscle during delivery or 4) for treatment of patients     with prolonged pregnancy.   "
235525|NCT00939757|"     The purpose of this study is to assess the effect of food on the pharmacokinetics of a single     oral dose of mirabegron in healthy male and female subjects.   "
235526|NCT00939770|"     RATIONALE: Crizotinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase I/II trial is studying the side effects and best dose of crizotinib and     to see how well it works in treating young patients with relapsed or refractory solid tumors     or anaplastic large cell lymphoma.   "
235527|NCT00939783|"     The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in     patients with Alzheimer's disease.   "
235528|NCT00939796|"     The objective of this investigational study is to evaluate the safety and performance of the     Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube     [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME)     or recurrent acute otitis media (AOM).   "
235529|NCT00939809|"     This phase II trial is studying the side effects and how well A6 works in treating patients     with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary     peritoneal cancer. A6 may stop the growth of tumor cells by blocking blood flow to the tumor.   "
235558|NCT00940186|"     Study on the phamacokinetics of Pikamilone in healthy Chinese subject and provide     informations for further phase II study.   "
235530|NCT00939822|"     The purpose of the research is to see how simvastatin affects a substance in the body called     beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and     spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting     Alzheimer's disease. This study will see if simvastatin can lower the amount of beta-amyloid     in the spinal fluid. This study will also see if simvastatin affects memory and thinking,     blood flow in the brain, and blood vessel function. The investigators hope that future     studies show whether simvastatin might prevent memory loss and decrease the chance of     developing Alzheimer's disease.   "
235531|NCT00939835|"     -  Objective:             -  The objective of this study is to compare the rate and extent of absorption of the               Test Product, Citalopram Hydrobromide 40 mg (Torrent Pharmaceutical Limited) to the               Reference Product, RLD Tablets 40 mg (Forest Pharmaceuticals Inc, Missouri) under               fed condition        -  Study Design:             -  Randomized, Single Dose, Open Label, Non-Replicate, Two-period, Two-treatment, Two-               Sequence Crossover Bioequivalence Study comparing Citalopram Hydrobromide Tablets               40 mg (manufactured by Torrent Pharmaceuticals Ltd). With RLD Tablets 40 mg               (manufactured by Forest Pharmaceuticals Inc Missouri) in 24+2 normal healthy male               subjects with a wash out period of 15 days between the two study periods, in fed               condition.   "
235532|NCT00939848|"     As a result of our previous NCRN study (ABC-02) cisplatin and gemcitabine (CisGem) is likely     to become the international standard of care for patients with advanced biliary tract cancer     (submitted: ASCO 2009).      This study, ABC-03, will determine whether the addition of cediranib(an oral Vascular     Endothelial Growth Factor Receptor inhibitor) to CisGem will improve the time to disease     progression in this patient group.   "
235534|NCT00939874|"     The purpose of this study is to determine if low bone mineral density (a measurement of how     thick and strong bones are) improves in adults with HIV infection who switch their HIV     medication tenofovir to another HIV medication raltegravir.      Hypothesis:That Bone Mineral Density (BMD) will improve in osteopenic or osteoporotic     patients switching from ART including tenofovir disoproxil fumarate (TDF) and a     ritonavir-boosted protease inhibitor (r/PI) to ART including RAL+r/PI.   "
235535|NCT00939887|"     This is a subject blind, investigator and sponsor open, randomized study consisting of 2     parts. Up to 15 healthy subjects will be included in the study. In the first part of the     study the test retest reliability of the radiotracer [11C] PF 04767135 binding in man will be     assessed. In the second part of this study, using [11C] PF 04767135, kappa opioid receptor     occupancy (RO) will be assessed in up to three cohorts of subjects.   "
235536|NCT00939900|"     The purpose of this study is to test the effect of zoledronic acid over 2 years in preventing     early collapse and progression of joint dome depression (≥ 2 mm by X-ray) of the femoral head     in patients with large (> 30%: criteria according to Kim et al) nontraumatic osteonecrosis.   "
235537|NCT00939913|"     In patients undergoing coronary angiography, the incidence of contrast induced     nephropathy(CIN)varies widely and ranges from < 5% in the lowest risk patients, to nearly 50%     in the highest risk patients. Prior data has shown oral n-acetyl cysteine (NAC) to be     effective in reducing the incidence of CIN.Due to extensive first pass metabolism, the     bioavailability of oral NAC is poor and ranges from 4%-10%. We hypothesize that the incidence     of CIN will be reduced in patients with ACS who undergo PCI by the prophylactic     administration of intravenous NAC.      This is a prospective, randomized, double-blind, placebo-controlled single center clinical     trial designed to evaluate the effects of intravenous NAC on patients with acute coronary     syndromes (ACS)undergoing coronary angiography and/or percutaneous coronary intervention     (PCI). The medication Acetadote is provided by Cumberland Pharmaceuticals Inc     (www.cumberlandpharma.com).      Patients will be excluded if they have end-stage renal disease requiring dialysis,known     hypersensitivity to NAC or a history of life-threatening contrast reaction. Primary end-point     is incidence of CIN. Secondary end-points are in-hospital mortality,30-day mortality,duration     of hospitalization and change in serum cystatin C level.   "
235538|NCT00939926|"     Objective:        -  To assess the bioequivalence of Risperidone 1.0 mg tablets of Torrent Pharmaceuticals          Limited., India and Risperdal® (Risperidone) 1.0 mg tablets of Janssen Pharmaceutical          Products, LP, USA, in healthy human adult subjects, under fed conditions.      Study Design:        -  A randomized, open label, two treatment, two period, two sequence, single dose,          crossover study, under fed conditions.   "
235539|NCT00939939|"     The goal of the study is to evaluate whether sitagliptin can affect postprandial lipoprotein     metabolism in type 2 diabetic patients.   "
235540|NCT00939952|"     The objective of this study is to characterize the pharmacokinetic profile of ertapenem     during continuous ambulatory peritoneal dialysis (CAPD).   "
235541|NCT00939965|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors plan better treatment for patients receiving isotretinoin.      PURPOSE: This clinical trial is studying the side effects and best dose of isotretinoin in     treating young patients with high-risk neuroblastoma.   "
235542|NCT00939978|"     The administration of rhEPO on the one day before cardiac surgery will be effective to     decrease the bleeding due to the surgery.   "
235543|NCT00939991|"     This is a Phase I/II open-label, single-arm study among recurrent malignant glioma patients.     Patients will be treated with Vorinostat in combination with Bevacizumab (BV) (10 mg/kg) and     Temozolomide (T) (50 mg/m2/day) BV is administered every 2 weeks. Temozolomide will be taken     orally once every day. Vorinostat will be taken orally on days 1-7 and 15-21 of each 28-day     cycle. In the phase I portion of this study, the dose of Vorinostat will be escalated in     successive cohorts of patients to determine the maximum tolerated dose (MTD) based on     dose-limiting toxicities (DLTs). In the phase II portion of this study, the dose of     Vorinostat will be the MTD determined in the phase I portion. The primary endpoint of the     phase II study is 6-month progression-free survival (PFS) for recurrent GBM (Glioblastoma)     patients. This study will be conducted at The Preston Robert Tisch Brain Tumor Center at     Duke.   "
235544|NCT00940004|"     Objectives:      This is an exploratory study, consisting of two parts. In part I a dose escalation is     performed and the primary objective is the safety of different doses of TLR-dendritic cell     (TLR-DC). In part II TLR-DC vaccination will be compared with cytokine-matured DC vaccination     and the primary objective of this part is the immunological response to TLR-DC vaccination,     with toxicity and clinical efficacy being secondary objectives. These studies will provide     important data on the safety and immunological effects of TLR-matured DC.      Study design:      This study is an open label prospective exploratory intervention study.      Study population:      The investigators' study population consists of HLA-A2.1 positive melanoma patients, with     proven expression of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma     patients with regional lymph node metastasis in whom a radical lymph node dissection is     planned or performed within 2 months of inclusion in this study (further referred to as stage     III) and melanoma patients with measurable distant metastases (further referred to as stage     IV) will be included.   "
235545|NCT00940017|"     The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to     determine the drug concentration in the lung.   "
235546|NCT00940030|"     The purpose of this study is to evaluate mechanical bowel preparation (MBP) with polyethylene     glycol plus bowel enema versus bowel enema alone in patients candidates to colorectal     resection for malignancy.   "
235561|NCT00940225|"     The purpose of this study is to determine whether or not XL184 demonstrates anti-tumor     activity in selected tumor types under a randomized discontinuation trial (RDT) design.     Subjects who have responded to study drug after 12 weeks of open-label XL184 administration     will continue to take XL184. Subjects who are clearly progressing will discontinue study     treatment and subjects who demonstrate stable disease will be randomized to either XL184 or     placebo. For individual patients, once disease progression is observed, the blind will be     broken and subjects who were randomized to placebo will be offered the option to receive     open-label XL184. Subjects who progressed while taking XL184 will discontinue study     treatment.      Emerging data may support enrollment in an open-label, non-randomized expansion cohort (NRE).     There will be NRE cohorts for prostate and ovarian cancers.   "
235547|NCT00940043|"     Prematurity represents 8% of birth and it is one of the leading causes of infant     complications. The preterm premature rupture of membranes (PPROM) represents one-third of     preterm birth and the rupture of membranes increase the risk of fetal exposition to infection     which could lead to neurological sequels. Classic management of women with PPROM before 32SA     is based on the extension of the pregnancy with the risk of adding complications like a     secondary infection. Moreover, different studies have shown that fetal infection could be one     of the most important risk factor for subsequent neurological complications. However, it is     difficult to know if it is better to extend the pregnancy to gain in maturity or to arrest     the pregnancy to avoid the risk of intrauterine infection. The research objective is to     suggest a new strategy to manage women with PPROM. With this new strategy, the investigators     seek to extend pregnancy as much as possible but the investigators would like to give birth     before the intrauterine infection. The investigators suggest detecting protein associate with     neurological complications of preterm child in the amniotic liquid found in the vagina of the     mother. A positive test will lead to the delivery of the newborn before its infection. The     hypothesis is that it is possible to study changes in the inflammatory status of patients who     presented an PPROM from repeated detection of interleukins in vaginal secretions.   "
235548|NCT00940056|"     Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to     rate control management of AF.      Secondary Objectives      Does totally endoscopic ablation:        -  reduce atrial fibrillation symptoms?        -  increase working capacity and improve quality of life?        -  improve atrial function?        -  reduce the risk for stroke?   "
235549|NCT00940069|"     The investigators performed a multicenter, open trial of using TS gene polymorphism to     predict advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as     first-line treatment.   "
235550|NCT00940082|"     Objectives: To investigate the cardiac condition of the diabetic patients in our hospital in     order to seek for the new diagnostic method of warning its cardiovascular complications in     early times.      Methods: 317 diabetic patients in our hospital from January in 2004 to July in 2008 were     divided into 2 groups: group A (106 patients whose age ranged from (31-59) and group B (211     patients whose age ranged from (60-90). The height, weight, blood glucose, glycosylated     hemoglobin, lipid, blood pressure, course of disease, ejection fraction (EF), fractional     shortening(FS), diameter of left ventricle in late diastolic stage(LVEDd), the thickness of     the ventricular septa（IVSDand the posterior wall of the right ventricle in late diastolic     stage (LVPWd)were recorded respectively. Left ventricular mass index (LVMI), relative wall     thickness (RWT) were calculated and High-sensitive C-reactive protein (HsCRP), homocysteine     and TNF-α were detected. Multifactor logistic regression was made based on the comparison and     contrast between all indexes to analyze the correlations between age and the positive     indexes.   "
235551|NCT00940095|"     The aim of this study is to demonstrate that clazosentan, administered as a continuous     intravenous infusion at either 5 mg/h or 15 mg/h until Day 14 post aneurysmal subarachnoid     hemorrhage (aSAH), reduces the incidence of cerebral vasospasm-related morbidity and     all-cause mortality within 6 weeks post-aSAH treated by endovascular coiling.      The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity,     and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the     following:        1. Death (all causes).        2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant          contributing cause, or not adjudicated to be entirely due to causes other than          vasospasm.        3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the          primary or relevant contributing cause, or not adjudicated to be entirely due to causes          other than vasospasm.        4. Administration of a valid rescue therapy in the presence of confirmed cerebral vasospasm          on angiography (DSA or CTA).      An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet     the primary endpoint and its individual morbidity components.   "
235552|NCT00940108|"     The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for     eliciting an immune response to H1N1 influenza in healthy children.   "
235553|NCT00940121|"     The purpose of this study is to assess the pharmacokinetics of three doses of oral mirabegron     formulations with three different release rates versus three doses of mirabegron administered     intravenously; to study safety and side effects of the oral and IV doses of mirabegron.   "
235554|NCT00940134|"     The purpose of this study is to investigate the effects of intravenous infusion of two     gastrointestinal hormones, PYY3-36 and GLP-1, alone and in combination, on appetite in     healthy obese men. The investigators hypothesize that an intravenous infusion of each hormone     alone will decrease food intake at a buffet meal and decrease appetite, and that in     combination, there will be a greater decrease in food intake and appetite compared to each     hormone alone.   "
235555|NCT00940147|"     Airway complications are a significant cause of morbidity after lung transplantation (LTx).     Bronchoscopic evaluation may help to identify risk factors for requiring interventions later.   "
235559|NCT00940199|"     Patients with breast cancer scheduled to undergo sentinel lymph node mapping and biopsy will     be randomly assigned to one of four treatment groups:      I: (Standard of Care at WRAMC): Application of L-M-X topical anesthetic cream 4% to the     breast within one hour of sub-areaolar injection of 4 ml 99mTc-sulfur colloid (1 mCi in     normal saline)      II. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium     bicarbonate)      III. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in 1% Lidocaine)      IV. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium     bicarbonate + 1% Lidocaine)      The primary study outcome is pain, which will be evaluated for each study group before, and     after radiocolloid injection utilizing a standardized 10-point Likert scale, the Wong-Baker     FACES Pain Rating Scale, and the McGill Pain Questionnaire. Physician appraisal of patient     pain (Wong-Baker FACES Pain Rating Scale) will be estimated during the radiocolloid injection     and compared with that of the patient.   "
235560|NCT00940212|"     The primary aim of this study is to investigate the safety and tolerability of AZD2423 single     doses in healthy volunteers.   "
235570|NCT00940342|"     The goal of this clinical research study is to learn if giving granulocyte-macrophage     colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of     rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of     this combination treatment will also be studied.   "
235562|NCT00940238|"     -  Objective:             -  To compare the rate and extent of absorption of Citalopram Hydrobromide Tablets 40               mg: Test Product: Citalopram Hydrobromide Tablets 40 mg manufactured by Torrent               Pharmaceuticals Limited, India Reference Product: CelexaTM Tablets 40 mg (Reference               Listed Drug) manufactured by Forest Pharmaceuticals Inc., Missouri under fasting               conditions in 36 healthy, adult, human subjects in a randomized crossover study.        -  Study Design:             -  Open-label, randomized, two period crossover studies in 36(Fasting)healthy, normal               subjects to compare the single dose bioavailability of Torrent's Citalopram               Hydrobromide tablets 40 mg and Forest Pharmaceutical's Celexa 40mg tablets.   "
235563|NCT00940251|"     To determine the safety and efficacy of an Ayurvedic formulation, Mersina in type 2 diabetic     patients with secondary failure to oral hypoglycemic agents, a randomized double blind,     single centre, study of 3 months duration was carried out.   "
235564|NCT00940264|"     Transvaginal hybrid procedures especially the transvaginal hybrid cholecystectomy are of     interest as an available NOTES-Procedure for the clinical routine. Few authors have     demonstrated the feasibility and safety in a selected patient collective. The aim of this     prospective data collection is to evaluate the feasibility in the clinical routine in a non     select patient collective.      Therefore all patients giving the informed consent to the transvaginal hybrid cholecystectomy     will be included and assessed concerning feasibility to perform the transvaginal approach and     complete the operation transvaginally.   "
235565|NCT00940277|"     The goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions     developed to reduce the psychological distress on women and their partners during and after     the breast cancer experience. The first group, an Enhanced Couple-Focused Group (ECG),     incorporates cognitive-behavioral interventions (e.g., relaxation, stress management skills)     as well as basic relationship communication and support skills (e.g., expressing support     needs constructively). The second group, a Couples' Support Group (SG), is a non-structured     group where general topics are discussed. The investigators will evaluate the impact of each     group condition on patients' psychological adaptation, social and role functioning, and     cancer treatment adherence. The investigators will also evaluate whether patient and partner     perceptions of relationship support, relationship intimacy, stress management skills, and     intervention group support mediate the groups' effects on each other's psychological     adaptation.      The investigators hypothesize that ECG will have stronger positive effects on patient general     and cancer-related distress and well-being than SG.      The investigators hypothesize that group support will mediate greater improvements in patient     psychological functioning in both groups but that the effects of group support will be     significantly stronger in SG than ECG.   "
235566|NCT00940290|"     Clinical practice guidelines (CPG) are systematically developed statements to assist     practitioner and patient decisions about appropriate health care for specific clinical     circumstances. They are developed to give a recommendation based on the best evidence     available. Through a randomized trial, the investigators intend to provide information about     which of the four grading systems most used today to grade evidence and recommendations in     CPGs, could change physician´s behavior towards a common clinical situation in daily     practice.   "
235567|NCT00940303|"     This single arm study will assess progression-free survival, feasibility of use and safety of     Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line     treatment in patients with metastatic colorectal cancer. Patients will receive up to 12     bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant     chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The     anticipated time on study treatment is until disease progression, and the target sample size     is <100 individuals.   "
235583|NCT00940511|"     The purpose of this study is to improve the quality of care for individuals with multiple     chronic conditions, health care systems have begun turning to coordinated care. Although     coordinated care can refer to many different things, it usually includes activities such as     assessing patients' needs, referring them to the right doctors, helping them make and keep     appointments, and helping them comply with medical or dietary recommendations. To understand     the effects of coordinated care for high-needs Medicaid recipients, MDRC is conducting a     randomized trial of a pilot coordinated care program run by Kaiser Permanente for blind and     disabled Medicaid recipients in the Denver area.   "
238062|NCT00973479|"     The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with     methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.   "
235568|NCT00940316|"     RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab     may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used     in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet     known whether erlotinib hydrochloride given together with panitumumab is more effective with     or without irinotecan in treating patients with metastatic colorectal cancer.      PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together     with panitumumab to see how well it works with or without irinotecan hydrochloride as     second-line therapy in treating patients with metastatic colorectal cancer.   "
235569|NCT00940329|"     This Phase I, open, randomized controlled, multiple-dose, parallel-group study investigated     the potential pharmacodynamic and pharmacokinetic interactions between multiple doses of oral     roflumilast and inhaled formoterol. Healthy male subjects were assigned to treatment A or     treatment B. Subjects in treatment A received 500 μg/d roflumilast from day 2 to day 18 and     48 μg/d formoterol from day 12 to day 18. Subjects in treatment B received 48 μg/d formoterol     from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18. Impedance cardiography,     ECG, serum potassium and glucose concentrations and effects on blood eosinophils assessed     potential pharmacodynamic interactions. In addition, the safety and tolerability were     evaluated. Pharmacokinetic parameters were assessed for roflumilast, roflumilast N-oxide, and     formoterol.   "
235571|NCT00940355|"     The purpose of this study is to determine the effectiveness of an intervention conducted by a     pulmonary nurse in patients with COPD.      The hypothesis is that in a sample of COPD patients with clinically relevant problems in     health status (physiological functioning, symptoms, functional impairment and quality of     life), a motivational intervention conducted by a pulmonary nurse will lead to     patient-tailored treatment and an improved health status.   "
235572|NCT00940368|"     Ginger root powder is found to be significantly effective,when given as an add-on therapy in     reducing chemotherapy induced nausea and vomiting in children and adolescents receiving     chemotherapy.      It is very cost effective and as compared to the other add-on therapy drug like aprepitant.   "
235573|NCT00940381|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of sirolimus and cetuximab that can be given to patients with advanced cancer.     The safety of this drug combination will also be studied.   "
235574|NCT00940394|"     The mutual support group intervention would significantly improve the families' burden of     care, functioning and social support, reduce the patients' severity of symptoms and     re-hospitalizations, and reduce the demands for utilization of family services, when compared     with the standard care group.   "
235575|NCT00940407|"     The purpose of this study is to evaluate clinical outcomes of Photobiomodulation treatment on     patients with dry Age Related Macular Degeneration (AMD).      Photobiomodulation is the use of non thermal, non laser light of specific wavelengths and     energy directly on the eye to improve retinal function and delay AMD progression.      This is a prospective 2 center phase 2 clinical pilot study with no placebo group.   "
235576|NCT00940420|"     This 2 arm open-label study will assess the safety and tolerability of combination treatment     with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis     C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week     and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the     treatment arms is to the discretion of the investigator (mainly according to genotype).     Adverse events will be monitored throughout the study and hematologic parameters every 2     weeks and twice during the 24-week follow-up.   "
235577|NCT00940433|"     This study compares the outcome of the four most commonly used operations for the repair of     primary groin hernia including the new key hole surgical techniques. It aims at answering the     question of whether the new technology really improve the outcome, saves time and reduce     patient suffering.   "
235578|NCT00940446|"     The purpose of this study is to compare the use of INSORB absorbable staples with metal     staples on surgical incision healing after total hip replacement. The study evaluates wound     healing, complications, and patient satisfaction regarding wound comfort and appearance after     surgery.   "
235579|NCT00940459|"     The purpose of this study was to evaluate the effect of different contact lens edge designs     on the circumlimbal conjunctiva.   "
235580|NCT00940472|"     The aim of this clinical trial is to compare the efficacy of DMMET-01 versus metformin     hydrocloride on metabolic control in mexican type 2 diabetes patients without prior     pharmacological treatment.   "
235581|NCT00940485|"     This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential     treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who     have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to     one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po     daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study     treatment is 3-12 months.   "
235582|NCT00940498|"     This is a two-part study of a compound called PF-05212384 (also known as PKI-587). The     purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a     Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In     Part 2 two cohorts will be enrolled. One cohort will assess safety, tolerability and     preliminary efficacy in 20 subjects at the MTD and will include subjects with breast cancer,     ovarian cancer, endometrial cancer, colorectal cancer renal cancer or glioblastoma (a type of     brain tumor). The other cohort will include 5 to 15 subjects with any type of tumor who     consent to provide tumor biopsies while participating in the study.   "
235584|NCT00940524|"     This research study is for people with a specific type of leukemia called Philadelphia     chromosome positive acute lymphoblastic leukemia (the type the patients have). The     investigators plan to give you combination of 3 drugs (dasatinib, mitoxantrone, cytarabine)     for the first part of the chemotherapy (called Induction). The investigators have previously     shown that the combination of mitoxantrone and cytarabine is very effective in your kind of     leukemia. The purpose of this study is to establish a safe dose range of dasatinib in     combination with this standard induction chemotherapy based on side effects. If possible, the     trial will also give us an idea of how well this combination might work in treating your     leukemia. Previous studies have shown that dasatinib can produce responses when given alone     for your kind of leukemia. By using the dasatinib together with the chemotherapy, the     investigators believe that we can kill even more leukemia cells than with either treatment     alone. The investigators will initially treat patients with a low dose of dasatinib and     monitor for side-effects. If the initial group of patients is able to tolerate this low-dose     of dasatinib, then future patients will receive higher doses of dasatinib. Mitoxantrone and     cytarabine chemotherapy is the standard therapy at the investigators' institution for the     patient's leukemia and it is the combination of dasatinib with this chemotherapy that is new     and investigational in this study.   "
235585|NCT00940537|"     The purpose of this study is to see how effective the investigators' optimized magnetic     resonance spectroscopy (MRS) sequence in quantifying hepatic triglyceride content (HTGC) to     enhance MRS as a diagnostic tool in non-alcohol fatty liver disease (NAFLD).   "
235600|NCT00940732|"     The purpose of this study is to determine whether positive mental health help-seeking     attitudes, and behaviour in elite athletes can be increased through an online intervention.   "
235601|NCT00940745|"     The purpose of this study is to evaluate the superiority of effect of the modified     micro-invasive aspiration and drainage and conservative medical therapy in the treatment of     ICH spontaneously hypertensive scientifically.   "
235602|NCT00940758|"     The purpose of this study is to evaluate the dose-limiting toxicity (DLT), toxicity profile,     maximum tolerated dose (MTD) and characterize the pharmacokinetics of biweekly PEP02     treatment.   "
235586|NCT00940550|"     This study has been designed to compare the effects of melatonin with those of drugs     (temazepam and zolpidem) regularly prescribed for the treatment of insomnia, in healthy,     middle-aged volunteers.      The study will take place at one centre. Volunteers consenting to participate in the study     will have their eligibility confirmed by a screening panel, including spending one night in     the sleep clinic to acclimatize to the study procedures. Blood and urine samples will be     collected during this overnight visit.      Volunteers continuing to remain eligible will receive, in turn, melatonin, temazepam,     zolpidem and placebo as a single dose during 4 treatment phases lasting one night and     separated by at least five days. Neither the volunteer nor the study staff will be aware of     which drug each volunteer is receiving at each treatment phase.      The volunteer's electrical brain activity will be measured whilst sleeping. Other aspects of     sleep, including measures of sleep quality, will also be measured. Urine samples will be     collected during each treatment phase.      Volunteers will undergo an assessment of health prior to departure from the clinic at their     last treatment phase, and study staff will telephone 2 weeks later to obtain further     information on their health status.      The primary study objective is to compare EEG power spectra during nonREM sleep in the     slow-wave frequencies following administration with melatonin to temazepam.   "
235587|NCT00940563|"     Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced     gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding     its best clinical use in terms of tumor response, survival, tolerability and safety profile     will be prospectively collected.   "
235588|NCT00940576|"     Mare's milk consumption could improve the well-being in patients with Crohn's disease and     ulcerative colitis, respectively.   "
235589|NCT00940589|"     The aim of this exploratory randomized, placebo controlled study is to evaluate the efficacy     of Circadin® 2mg in patients with mild to moderate Alzheimer Disease (AD) treated with the     acetylcholinesterase (AChE) inhibitor. The effects of add-on Circadin® 2mg vs. placebo on the     decline in cognitive skills and global functioning, as well as on daytime somnolence and will     be assessed.   "
235590|NCT00940602|"     The primary purpose of this study is to prospectively assess the efficacy and safety of iron     chelation therapy with deferasirox compared to placebo in patients with myelodysplastic     syndromes (low/int-1 risk) and transfusional iron overload.   "
235591|NCT00940615|"     The current project will examine the effects of aerobic exercise on cognition among a group     of veterans who have suffered a mild traumatic brain injury.   "
235592|NCT00940628|"     This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or     overweight adolescents. Patients will be randomised into one of 2 groups; both groups will     undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also     receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the     target sample size is <100 individuals.   "
235593|NCT00940641|"     The purpose of this study is to evaluate the absorption, distribution, metabolism and     excretion of AZD7325 after intravenous and 14C labeled oral dose   "
235594|NCT00940654|"     The purpose of this multination multicenter observational study is to determine the impact of     fever and antipyretic on outcomes in critically ill patients.   "
235595|NCT00940667|"     The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan     and amlodipine alone in patients with essential hypertension inadequately controlled on     amlodipine monotherapy.   "
235596|NCT00940680|"     The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan     and losartan alone in patients with essential hypertension inadequately controlled on     losartan monotherapy.   "
235597|NCT00940693|"     The purpose of this study is to determine whether duloxetine is an effective treatment of     attention deficit disorder in adults.   "
235610|NCT00940862|"     This study is to determine the effect of adalimumab on inflammation of blood vessels that     could lead to heart attack in patients with psoriasis. Changes to the carotid artery and     ascending aorta will be evaluated in patients treated with adalimumab (systemic treatment)     and compared against patients treated with a topical treatment that does not affect the     entire body.   "
235611|NCT00940875|"     This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva     and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients,     or patients with ECOG performance status of 2, with advanced non-small cell lung     cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on     days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine     monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on     study treatment is 3-12 months, and the target sample size is 100-500 individuals.   "
235598|NCT00940706|"     There is increasing evidence that physical activity during childhood and adolescence has an     important impact on health and behavior outcomes. Lack of physical activity is currently a     major concern for the total population and especially for children and adolescents. People     with disabilities are at risk for the same health problems as the general population. Due to     their disabilities, they have a higher risk for developing secondary conditions that may     further affect their health and quality of life.The goals of this project are to develop and     evaluate new approaches of treatment for children with cerebral palsy (CP) and to develop low     cost tests for evaluating motor functions in natural environments.      The overall aim is to raise awareness of, and promote, a physically active lifestyle for     Middle East teenagers with disabilities due to CP by means of a collaborative     Jordanian-Israeli-Palestinian-Moroccan applied research project. Specific objectives include:        1. Evaluation of baseline levels of physical activity in large populations of children and          teenagers with CP in the communities of the participating countries by long-term          monitoring by accelerometers.        2. Conducting a randomized clinical trial to compare the efficacy of an experimental          physical training program with a treadmill training program in two groups. The          experimental training program is based on results of recent motor control studies, as          well as the motor learning approach to facilitate transfer and retention of learned          walking activities.        3. Disability Advocacy through dissemination of activity focus programs, raising awareness,          making use of new technologies and enhancing and developing the skills and training of          personnel working with populations with CP.        4. Continuing the expansion of collaborative research efforts pertaining to children and          teenagers with physical disabilities between Arab countries and Israel through sharing          of skills and knowledge by exchange visits, meetings and seminars and joint training,          pediatric physiotherapists and physical educators.   "
235599|NCT00940719|"     In patients with Relapsing Remitting Multiple Sclerosis (RRMS), the investigators observed a     positive correlation between regulatory T cell (Treg) function and vitamin D status. The     present goal is to assess whether Treg function improves on supplementation with vitamin D3.   "
235620|NCT00940992|"     To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients     with rosacea.   "
235603|NCT00940771|"     The hypothesis for this study is will a treatment regimen containing Atazanavir in     combination with Ritonavir work as well as other regimens containing a protease inhibitor     (PI, one of 5 classes of HIV Medications) and/or a Non-nucleoside Reverse Transcriptase     Inhibitor (NNRTI, another of the classes of HIV medications) at controlling HIV disease in     children who are HIV+ and have high cholesterol or high triglycerides. . In this study,     children who have high cholesterol or high triglycerides as a result of their HIV medicines,     will have the PI or NNRTI in their medication regimen changed to Atazanavir, which is a PI in     combination with a low dose of Ritonavir (another PI). Atazanavir has been shown in adults to     result in lower cholesterol and triglycerides than other PI's and NNRTI's. The dose of     atazanavir and ritonavir will be according to the Package Insert for this drug that is FDA     approved for children. They will continue taking the other medications from the pre-study     regimen. Children will take study drug for 24 weeks, and will be able to continue study drug     after the study using commercially available drug. Lab tests and a physical exam will be     undertaken at 4 weeks, 12 weeks and 24 weeks after starting study drug to determine how     effective the new drug is and to monitor for possible side effects.   "
235604|NCT00940784|"     Clopidogrel (Plavix) and aspirin are two antithrombotic agents (blood thinners) commonly used     in patients with previous thrombotic events (stroke or heart attack). Thrombosis is the     formation of a blood clot in a blood vessel. Patients with polycythemia vera are routinely     treated with aspirin which has been shown to be effective in reducing their thrombotic risk.     However, in polycythemia vera patients with previous thrombosis, a further benefit might be     obtained by using the combination of aspirin and clopidogrel which is routinely used in     patients with recent acute myocardial ischemia (reduced blood supply to the heart muscle).     The study will assess whether this combination therapy greatly increases the risk of bleeding     versus aspirin alone, if clopidogrel reduces biological factors that might lead to a stroke     or heart attack, and whether a high number of patients with polycythemia vera are resistant     to clopidogrel.      Approximately 200 subjects will be enrolled to the Myeloproliferative Disorders-Research     Consortium (MPD-RC) study in Europe and the United States with participation expected to last     for 7 months (6 months of receiving study medication plus a 30 day follow-up visit).   "
235605|NCT00940797|"     The aim of this study is to determine the effect of DMMET-01 on insulin sensitivity by     Glucose CLAMP technique in Mexican type 2 diabetes patients, after 2 months of treatment.   "
235606|NCT00940810|"     The purpose of this study is to compare the plasma disc decompression (PDD) procedure to     conservative care (physiotherapy) for the treatment of patients with radicular pain     originating from a disc protrusion. Treatment efficacy and rate of improvement is evaluated     at 8 weeks after treatment start and followed-up for 1 year after treatment start.   "
235607|NCT00940823|"     The purpose of this study is to compare the safety and efficacy of the Ahmed valve and the     Baerveldt implant in treating refractory glaucoma. Eligible patients will be recruited from     multiple study centers and randomized to a glaucoma drainage device for implantation. They     will be followed long-term based upon outcome measures including intraocular pressure,     glaucoma medication use, visual acuity, complications of the surgery and further treatments     required.   "
235608|NCT00940836|"     The aim of this study is to assess the efficacy and safety of an anti-cold preparation     compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and     flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled     clinical trial.   "
235609|NCT00940849|"     Background of the study:      Plant sterols can play an important role in lowering plasma cholesterol. The extent to which     plant sterols can reduce plasma cholesterol levels depends on the intake scenario. We suggest     that the difference in these effects depends on gastric emptying and bile secretion.      Objective of the study:      The aim of this study is to gain insight in the mechanisms that may be involved in the     effects of plant sterol drinks on gastric emptying and gallbladder motility. In order to test     this, we compare the different effects of the consumption of a plant sterol containing drink     prior to, during and after a standardized meal.   "
235612|NCT00940888|"     The purpose of this study is to characterize the chronic performance of the St. Jude Medical     SJ4 connector and RV high voltage SJ4 leads.   "
235614|NCT00940914|"     About 46% of patients suffering from Parkinson's disease present pain disorders. Parkinson     disease is characterized by loss of dopaminergic neurons. The aim of this study is to assess     the relationship between the loss of dopaminergic neurons and the existence of pain in     Parkinson's disease. Using single photon emission computerized tomography (SPECT) imaging     (123I FP-CIT, which binds dopamine transporter) and the determination of subjective pain     threshold, the investigators will establish correlations between dopaminergic degeneration     and pain perception.   "
235615|NCT00940927|"     The purpose of this study was to determine the lung function response after increasing doses     of albuterol (a bronchodilator) in children and adults with asthma.   "
235616|NCT00940940|"     Varicella zoster virus is part of the herpesvirus group and causes chickenpox in exposed     individuals. The majority of the population is seropositive for this virus. Reactivation of     varicella zoster virus occurs in up to 30% of the general population over 60 years old.      Solid organ transplant recipients receive lifelong immunosuppression drugs and are at great     risk of reactivation of all herpesviruses including the varicella zoster virus regardless of     age. The vaccine has been shown to be effective in preventing shingles in the general     population. The investigators' purpose is to determine how well the vaccine works in patients     on renal replacement therapy and post-transplant.   "
235617|NCT00940953|"     The primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide +     Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients     with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen.   "
235618|NCT00940966|"     The purpose of this study is to determine the effectiveness of two different non-energy     restricted controlled carbohydrate programs with the American Diabetes Associations' diet on     glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic     syndrome, a constellation of symptoms associated with the development of type 2 diabetes and     cardiovascular disease.   "
235619|NCT00940979|"     The purpose of this study is to prove a reduction of postoperative wound infections after     direct preoperative use of a microbial sealant in the form of Integuseal for vascular     procedures on lower extremities.   "
235621|NCT00941005|"     Introduction: Current rates of postoperative nausea and vomiting (PONV) experienced by     outpatient surgery patients are as high as 20-30%. Electroacustimulation (EAS) therapy has     been demonstrated to be effective in controlling these symptoms, but trials identifying their     efficacy in the outpatient surgery population are lacking. This study integrates conventional     pharmacotherapy with alternative medicine in prevention of PONV.      Materials and Methods: One hundred twenty two patients undergoing surgery procedures at an     outpatient surgery center were randomized to two treatment arms. The first arm was     standardized pharmacologic PONV prevention typical for patients undergoing outpatient     surgery, while the second arm employed the use of ReliefBand, an FDA-approved     electroacustimulation (EAS) device with pharmacologic treatment to relieve symptoms of PONV     and pain. EAS is a derivative of acupuncture therapy that uses a small electrical current to     stimulate acupuncture points on the human body and is thought to relieve nausea, vomiting and     pain. Outcomes measured were post-op questionnaires evaluating pain and nausea symptoms,     emetic events, the need for rescue medications and the time to discharge.   "
235622|NCT00941018|"     This study is being conducted to determine the safety, tolerability, pharmacodynamics and     pharmacokinetics of RX-10001.   "
235623|NCT00941031|"     The purpose of the study is to determine whether, in patients with moderate to severe     plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis     symptoms and the extent to which the patient's body area is affected by the disease (compared     to placebo).   "
235624|NCT00941044|"     Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA     delivers assistance to spontaneous breathing based on the detection of the electrical     activity of the diaphragm. The investigators will study the effects of non-invasive NAVA in     respiratory muscle unloading in healthy volunteers.   "
235625|NCT00941057|"     Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG) after     administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest     and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 2 mg     Estradiol Valerate,3 mg Dienogest.Investigation of the bioequivalence of levomefolate calcium     after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg     Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing     0.451 mg levomefolate calcium   "
235626|NCT00941070|"     This phase II trial is studying how triapine and cisplatin given together with radiation     therapy works in treating patients with cervical cancer or vaginal cancer. Triapine may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used     in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving triapine together with cisplatin may make     tumor cells more sensitive to radiation therapy.   "
235627|NCT00941083|"     A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically     and immunologically. Moreover, it will be associated with significant improvements in the     lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a     day (QD) will perform as well as RAL twice a day (BID).   "
235628|NCT00941096|"     The purpose of this study is to examine the ocular hypotensive effect of Bimatoprost and the     potential additional effect of the Bimatoprost/Timolol fixed combination in eyes with ocular     hypertension, primary open angle glaucoma or exfoliation glaucoma.   "
235629|NCT00941109|"     The purpose of this study is to determine how the body absorbs decitabine when taken orally     in patients with Myelodysplastic Syndrome (MDS). Safety will also be assessed for this oral     dose.   "
235717|NCT00934089|"     This study will characterize the effect of PF-04217329, alone and in combination with     latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood     samples will be collected to measure the amount of active metabolite of PF-04217329 in the     plasma following dosing.   "
235630|NCT00941122|"     1.To assess whether the Elution swab (ESwab) is superior to Amies transport swabs for the     detection of Methicillin Resistant Staphylococcus aureus (MRSA) and Vancomycin Resistant     Enterococci (VRE) in colonized patients and to determine whether nasal cultures alone is     sufficient for detection of MRSA isolates in hospitalized patients. 2.To assess patient     comfort in the use of the ESwab vs. Amies Transport swab for screening patients for     methicillin resistant Staphylococcus aureus and vancomycin-resistant Enterococcus.   "
235631|NCT00941135|"     To evaluate the progression free time in patients with completed or partial response > 30%     evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin,     5-FU) treated with RT + Cetuximab over 2 years.   "
235632|NCT00941148|"     The aim of the study is to show that treatment with Glargine will lead to an improvement in     beta cell function especially within times of maximal beta cell stress occurring after a     meal. For this reason three different standardized test meals (breakfast, lunch, dinner) will     be performed and the postprandial secretion of intact proinsulin levels will be measured.     These measurements will be performed with patients treated in combination with metformin and     insulin glargine versus metformin plus NPH insulin (within the core study) and if significant     difference is observed, with a third treatment arm with metformin plus insulin detemir.      Hypothesis is that the area under the curve (AUC) intact proinsulin levels within 2 hours     after test meal dinner of metformin plus insulin glargin differs from AUC intact proinsulin     levels of metformin plus NPH insulin.   "
235633|NCT00941161|"     The aim of the study is to determinate the effect of combined oral therapy of long acting     metformin/glimepiride in a single dose in patients with type 2 diabetes mellitus and     monotherapy failure.   "
235634|NCT00941174|"     The objective of this study is to determine whether the intact human colon with an unaltered     microflora distribution absorbs folate and to what extent it is absorbed into the systemic     circulation using a dual/oral intravenous route. This will elicit an understanding of colonic     folate absorption and metabolism.   "
235682|NCT00933621|"     The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow     (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for     revascularization.   "
235635|NCT00941187|"     The purpose of this monocentric, preliminary study is to assess the evolution of pulmonary     capillary blood volume (Vc), measured by the double diffusion nitric oxide/carbon monoxide     (NO/CO) method (Guenard et al.; Respir Physiol 1987), from the starting of the anticoagulant     therapy to 6 months after, and to search correlations with the evolution of clinical (dyspnea     and results of the 6 minutes walking test), biological (BNP; Troponin), echocardiographic     (right ventricular dysfunction, pulmonary arterial pressure) and ventilation/perfusion lung     scan data.   "
235636|NCT00941200|"     Aims of Research Proposal:        1. To build a DNA bank in association with a comprehensive database of treatment outcomes          and toxicities of cancer patients.        2. To carry out genotyping of potential candidate genes in relation to specific anti-cancer          agents and to correlate genotype with treatment outcomes and toxicities.      The investigators hypothesize that genetic variations between different individuals and     ethnic groups may account for inter-individual and inter-ethnic differences in treatment     response and toxicities to anti-cancer therapy. The understanding of the contribution of     these genetic variations may help to individualize therapy to optimize treatment outcomes and     reduce toxicities. Patients will be recruited from the National University Hospital Cancer     Centre. Any individual aged 18 or above who has been diagnosed with cancer is eligible. 20 ml     of blood will be collected from each subject for DNA extraction and pharmacogenetics     analysis. At the time of recruitment, demographic characteristics, cancer history, and past     and present cancer treatment history of the study subject will be collected. The patients'     progress will be followed up periodically (approximately every 6 months) through the medical     records, and subsequent cancer treatments, progression of cancer, and survival outcome will     be updated. Follow-up will occur until death. Important treatment information that will be     collected include the drug regimen, drug doses, intent of treatment, aematologic and     non-haematologic toxicities, and hospitalization episodes that may be related to treatment.     Known functional single nucleotide polymorphisms (SNPs) of drug metabolizing enzymes,     transporters and targets of different anti-cancer agents will be characterized. More     comprehensive genotyping will be carried out in 'outliers' who experience exceptional     toxicity or biological response to identify novel functional SNPs using high throughput     sequencing techniques. Correlation will be made between genotype and treatment-related     outcomes (tumor response, progression-free survival) and toxicities. For selected patients,     lymphoblastoid transformation will be carried out to maintain an infinite supply of DNA.   "
235637|NCT00941213|"     This study was undertaken to investigate the effect of using ultrasound scissors in the     preparation for Thoracoscopic Ventral Spondylodesis. Quantity of bleeding and the duration of     operation in Thoracoscopic Ventral Spondylodesis are compared to the preparation with     monopolar electrosurgery.   "
235638|NCT00941226|"     Cerebral Palsy (CP) is characterized by a sensory-motor deficiency, involving disturbance of     muscle tone, posture and voluntary movement. Children who are afflicted need special intense     care for their carers   "
235639|NCT00941239|"     The purpose of this study is to determine the gastric tolerability and the pharmacokinetics     of an extended release metformin compared with an immediate release metformin in healthy     subjects.   "
235640|NCT00941252|"     The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and     persistent CIN 2 represents conisation. Surgical treatment can cause perioperative     (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor)     complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%.     Imiquimod is an immunomodulating drug, that has been reported to be effective in human     papilloma virus-related disease, such as vulvar intraepithelial neoplasia (VIN), vaginal     intraepithelial neoplasia (VAIN), and anal intraepithelial neoplasia (AIN). The present     randomised, placebo controlled, double blind study evaluates the efficacy of a topical     treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed CIN 2/3.   "
235665|NCT00933400|"     This multi-center, randomized, controlled trial conducted in Emergency Departments (ED)     compares computed tomography (CT) coronary angiography with the traditional approach (usual     care) for low- to intermediate-risk chest pain patients. The primary objective is to estimate     the rate of major cardiac events (heart attack or cardiac death) within 30 days in trial     participants in Group B who were not found to have significant coronary artery disease by CT     coronary angiography. Additional evaluations will comprise health care utilization     assessments, including length of hospital stay and re-admissions, cost analysis, and 1-year     post-triage/presentation major cardiac event rates.   "
235666|NCT00933413|"     Primary Objective:      To prove the safety of the gynecological formulation in normal conditions of use.   "
235718|NCT00934102|"     The purpose of this study is to assess the ophthalmic compatibility of three different     silicone hydrogel lenses worn on an overnight basis for six nights.   "
235905|NCT00942344|"     The purpose of this study is to evaluate the safety and efficacy of fixed combination of     amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in     reducing blood pressure. The study will investigate the dose response relationship for the     combinations and monotherapies.   "
235641|NCT00941265|"     The investigators have been offering computer assisted therapy of aphasia (CAT) as a     complement to traditional treatments to aphasia patients of the Service of     Neurorehabilitation for some years. The investigators have shown its efficacy in     hospitalised patients with recently acquired aphasia.      In addition to studies stressing the importance of treatment intensity, several studies     suggest that pharmacological treatment can also improve recovery after a cerebral lesion. The     underlying idea is that the administration of medication influencing the system of     neurotransmitters can play a role in functional recovery. Studies have assessed mainly     substances acting on the dopaminergic (amphetamine and bromocriptine) and GABAergic system     (piracetam).      The main objective of the present study concerns the evaluation of the effects of levodopa on     recovery of anomia in patients with aphasia. In particular, the investigators use CAT to     control intensity and quality of therapy and they will assess whether the administration of     levodopa promotes recovery.      In each patient, two periods of anomia therapy with CAT, each performed with a different word     list, will be compared. In addition to speech therapy, each period will be associated with     the administration of either levodopa and benserazide (Madopar ®), or placebo. Evaluations at     baseline and after each treatment period will be performed with the material and denomination     battery   "
235642|NCT00941278|"     PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical     administration to the skin, and is being studied for the treatment of cutaneous skin     disorders, specifically psoriasis and atopic dermatitis. This phase 2 efficacy and safety     study will assess topical PH-10 applied once daily to areas of mild to moderate plaque     psoriasis.   "
235643|NCT00941291|"     The purpose of this study is to evaluate the role of cataract surgery and cystoid macular     edema (CME) on reopening of idiopathic macular holes (IMH).   "
239435|NCT00982475|"     Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients     with drug refractory atrial fibrillation are not inferior to manual radiofrequency current     ablation.   "
235644|NCT00933127|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at blood and tissue samples from patients with     follicular lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride,     vincristine, and prednisone.   "
235645|NCT00933140|"     The population of HIV infected women seen at Boston Medical Center may have a higher     frequency of anal cytologic and histologic abnormalities than what is reported for the     non-HIV infected population.   "
235646|NCT00933153|"     Researchers will measure weight, height, hand grip strength and quality of life information     of Meals on Wheels (MOW) clients who are considered to have nutrition problems. Participants     will randomly be put into a group that receives either typical meals from Meals on Wheels or     Ensure Plus supplements with their meals. Three months later the same data will be collected     again. The objective of this study is to demonstrate the effectiveness of providing oral     nutritional supplements (ONS) to MOW clients with or at risk of malnutrition on nutritional     status over a 3-month period.   "
235647|NCT00933166|"     The purpose of this trial is to assess the performance of an investigational contact lens     over a three month period.   "
235648|NCT00933179|"     The aim of the present study is to investigate the effects of the transdermal patch on the     parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism     in healthy women who require contraception.   "
235649|NCT00933192|"     The evaluation of skeletal muscle strength in severly ill or cognitive impaired patients is     an unresolved problem especially during the rehabilitation process. The aim of this study is     to correlate morphological parameters assessed with muscle ultrasound and isometric muscle     strength to establish an objective progression parameter for rehabilitation therapies.   "
235650|NCT00933205|"     The purpose of this Open Label Safety Study is to provide access to and evaluate the safety     and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who     have failed at least two PI-containing regimens, and have limited treatment options.   "
235651|NCT00933218|"     The purpose of the study is to determine the myocardial function and vascular adaptation     after strenuous exercise in association with consumption of polyphenols. The investigators     aim to investigate the effects of extreme endurance exercise on the inflammatory system.     Furthermore, the role of the cardiovascular response and adaptive mechanisms of the     vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being     investigated.   "
235652|NCT00933231|"     This is a multicentre study examining the use of Advagraf-minimization strategy and/or the     use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal     allografts.   "
235653|NCT00933244|"     The purpose of this study is to answer the following questions: Does vitamin D increase     calcium absorption, bone mass and muscle mass and function in women past menopause who have     mildly low vitamin D levels? Do these benefits require prescription-strength vitamin D, or is     an over the counter vitamin D dose enough?   "
235654|NCT00933257|"     Primary Objective:      To demonstrate the absence of photoirritation and potential photosensitization of the product     Dermacyd PHDESILSTYFR.   "
235655|NCT00933270|"     This is a prospective, multicenter, non-randomized, single arm, pivotal trial.      The main objective of this study is to demonstrate the safety and effectiveness of the IDev     SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral artery     (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated at 12     months. The outcome will be compared to a performance goal based on clinical trials of     percutaneous transvenous angioplasty (PTA) alone.   "
235656|NCT00933283|"     The purpose of this study is to evaluate the effect of steady-state (constant concentration     of medication in the blood) telaprevir 750 mg every 8 hours on the steady-state     pharmacokinetics (how the drug concentrations change over time) of R- and S-methadone.   "
235712|NCT00934024|"     The purpose of this study is to evaluate the impact of varenicline treatment on cue induced     craving to smoking using brain imaging. The investigators hypothesize that participants will     report reduced urges to smoke and will have less activation in parts of the brain associated     with craving.   "
235934|NCT00942734|"     The goal of this clinical research study is to learn if RAD001 in combination with Tarceva     (erlotinib hydrochloride) can help to control head and neck squamous cell cancer (HNSCC). The     safety of this drug combination will also be studied.   "
235657|NCT00933296|"     The Schnitzler syndrome is a rare entity characterized by an urticarial rash and recurrent     fever in a patient with a monoclonal IgM component. Other frequent signs include joint, bone     and muscle pain, enlarged spleen, liver and lymph nodes, increased blood sedimentation rate     (BSR), elevated neutrophil count and abnormalities on bone morphologic investigations. In     2001, the investigators proposed criteria to diagnose this syndrome, which are currently     admitted in the literature. The main complications of the Schnitzler syndrome are a     difficult-to-control inflammatory anemia, AA-amyloidosis and malignant B lymphoproliferative     disorders. About 15% of patients with a Schnitzler will eventually develop a     lymphoproliferative disorder; thus this syndrome allows studying the relationship between     lymphomagenesis and inflammation. By many aspects, the Schnitzler syndrome is reminiscent of     auto-inflammatory syndromes. Though the term auto-inflammatory disease is as to yet     restricted to diseases with Mendelian inheritance, some polygenic inflammatory diseases like     for example Crohn's disease clearly involve pathogenetic pathways shared with the monogenic     auto-inflammatory syndromes. The investigators stipulate that this could also be the case in     the Schnitzler syndrome for the following reasons: (1) this is a recurrent fever of unknown     cause; (2) the peculiar eruption, characterized pathologically by a neutrophilic infiltrate     very similar to the one observed in the auto-inflammatory cryopyrinopathies (CINCA/NOMID     syndrome, Muckle-Wells syndrome and familial cold-urticaria); the investigators recently     individualized this particular eruption, significantly associated with systemic inflammatory     disease, within the group of neutrophilic urticarias (Kieffer et al. Medicine, in press); (3)     the occurrence of aseptic neutrophilic osteitis, very similar to the one reported in patients     with Majeed syndrome, another auto-inflammatory syndrome; (4) a significant increase of     neutrophil count, not otherwise explained; (5) a spectacular response to the IL-1 inhibitor,     within hours after the first injection, similar to what is reported in the PAPA (pyogenic     arthritis, pyoderma gangrenosum and acne) syndrome or the cryopyrinopathies, suggesting a     direct pathogenic effect of IL-1.   "
235658|NCT00933309|"     The goal of this clinical research study is to find the highest tolerable dose of Avandamet     that can be given in combination with exemestane to patients who are obese and postmenopausal     with hormone-receptive-positive breast cancer that has spread to other parts of the body.   "
236773|NCT00947050|"     The purpose of this study in humans with stable coronary artery disease (CAD) treatable by     PCI (percutaneous coronary intervention) is to evaluate if dynamic physical exercise leads to     an instantaneous improvement of coronary collateral function.   "
235659|NCT00933322|"     The aim of the study is to compare a diet rich in trans fatty acids (TFA) from ruminant     sources with a diet rich in TFA from hydrogenated vegetable oils (PHVO) in regard to their     effects on cardiovascular risk markers (endothelial function, blood lipids, inflammation and     coagulation parameters in the blood).      After a two week run-in period (diet without TFA) volunteers are randomized into three groups     with different diets: diet rich in TFA from ruminant sources, diet rich in TFA from PHVO and     diet without TFA. The intervention period lasts four weeks.      A nutritionist introduces the basic issues of the study diets. All volunteers supply     themselves according to the recommendations of the Swiss food pyramid. Fat free food can be     chosen individually in the context of defined guidelines. The amount and source of the fat in     the diet are strictly defined. During the whole study, volunteers meet the nutritionist every     2 weeks, and in the weeks between, the volunteers are contacted by phone.      The volunteers will continue their normal daily life and physical activities. At the     beginning of the run-in period and at the beginning and the end of the intervention period     the endothelial function of the brachial artery will be assessed using flow-mediated dilation     (FMD)/nitro-mediated dilation (NMD) methods and blood samples will be collected to analyze     blood lipids, inflammation and coagulation parameters in the blood.      Hypothesis:        1. Diet enriched with ruminant TFA has not the same negative effect on cardiovascular risk          markers as diet enriched with the same amount of industrial TFA compared with a diet          without TFA.        2. Diet enriched with ruminant TFA has not a more negative effect on cardiovascular risk          markers as diet without TFA.   "
235660|NCT00933335|"     This is a single-arm, single institution, phase II study of fludarabine monophosphate     followed by Iodine I 131 Tositumomab for patients with previously untreated, advanced-stage     (stage III or IV) low-grade, transformed low-grade and follicular non-Hodgkin's lymphoma. The     primary objective of the study will be to evaluate the safety of this treatment combination     and the secondary endpoint will be to evaluate efficacy.   "
235661|NCT00933348|"     The purpose of this study is to examine the safety and efficacy of the fruit-based product     OPAL A for the treatment of chronic venous and pressure ulcers.   "
235662|NCT00933361|"     Cachexia, a condition of severe malnutrition, negative nitrogen balance, muscle wasting,     weight loss, and anorexia, is a frequent affecting more than 80% of patients in advanced     cancer disease causing a high burden on patients and their families. Nutritional,     pharmacological, and behavioural interventions for cancer-related ACS and associated symptoms     have, despite the importance for cancer care, limited effect on only a minority of patients.     New strategies are required.      Ghrelin, a 28 amino acid peptide discovered in 1999, is predominantly secreted by gastric     endocrine cells and is an endogenous ligand for the growth hormone secretagogue (GHS)     receptor. When administered peripherally it stimulates growth hormone secretion, food intake,     triggers a positive energy balance, produces weight gain through a central mechanism     involving hypothalamic neuropeptides and has anti-inflammatory effects. A recently completed     trial on intravenous ghrelin in advanced cancer patients with ACS reports good tolerability     and safety of single intravenous application of 2 and 8μg/kg Ghrelin.      Given the facts that ACS is a major burden in patients suffering advanced cancer disease and     ghrelin is a major signal for stimulating food intake, promoting positive energy balance and     weight gain and may have anti-inflammatory effect it remains to be determined whether the     administration of ghrelin will have a positive clinical effect on cancer anorexia/ cachexia     syndrome ACS. The next logical clinical development step is a proper dose-finding study of     twice daily subcutaneous administration and proof-of-concept of main outcomes.   "
235663|NCT00933374|"     This is a single arm open- label phase II- trial evaluating safety and efficacy of paclitaxel     and RAD001 in patients with metastatic urothelial bladder cancer who failed prior     platin-based systemic therapy.   "
235664|NCT00933387|"     Surgical resection followed by concurrent chemoradiotherapy is considered as the standard of     care for locally advanced OSCC (LAOSCC). Although the treatment could provide prompt local     control, but it is also associated with high incidence of distant failure. Systemic     chemotherapy given either before (neoadjuvant) or after (adjuvant) definitive local treatment     has been extensively evaluated to improve the clinical outcome in LAOSCC. Regimens of     taxane/cisplatin-based combinations have been shown to improve the treatment outcome of     patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in neoadjuvant     setting. Recently, cetuximab (Erbitux®), a monoclonal antibody against epidermal growth     factor receptor (EGFR), has also been proven to be an efficient agent for advanced and/or     refractory HNSCC with acceptable toxicity profiles. In current study, we shall evaluate the     feasibility, efficacy and safety of a triplet bio-chemotherapy consisting of cetuximab,     paclitaxel, and cisplatin followed by cetuximab-based concurrent bio-radiotherapy (CBRT) in     patients with LAOSCC.   "
235667|NCT00933426|"     The goal of the Phase I part of this clinical research study is to find the highest tolerable     dose of Revlimid® (lenalidomide) that can be given in combination with paclitaxel to patients     with prostate cancer who have failed treatment with taxanes.      The goal of the Phase II part of this clinical research study is to learn if lenalidomide and     paclitaxel can help to control prostate cancer.      The safety of this combination treatment will be studied in both phases of the study.      UPDATE:      Study was terminated early due to slow accrual as a Phase I dose escalation study, without     progression to Phase II study portion.   "
235668|NCT00933439|"     The purpose of this study is to study the effect of duloxetine treatment on (1) cognitive     functions, the brain mechanisms involved with thinking, reasoning, learning, and remembering;     (2) psychosocial functions, how someone interacts with his/her social environment; and (3)     the relationship between these two functions, in people who have major depressive disorder, a     severe form of depression.   "
235669|NCT00933452|"     The primary objective of this study is to evaluate the pharmacokinetics of duloxetine     hydrochloride tablets in Chinese Han Healthy Subjects. The single oral dose and multiple oral     dose of the drug in the body and the effects of different dosages of the drug will also be     evaluated.   "
235683|NCT00933634|"     The optimal strategy to restore sinus rhythm in patients with atrial fibrillation (AF) of     less than 48 hours' duration is still controversial. The investigators performed a controlled     single-center trial to compare electrical and pharmacological (propafenone) cardioversion to     restore the sinus rhythm in selected patients with acute atrial fibrillation.   "
235670|NCT00933465|"     Faecal incontinence (FI) is a debilitating and often neglected problem. It can be defined as     the loss of voluntary control of liquid or solid stool.It is estimated that 2-3% of western     adults suffer from FI with prevalence increasing with age, further to this up to 50% of     nursing home residents suffer too with it more common in females. Aetiology is often     multi-factoral, where obstetric anal sphincter injury is most common is females and     iatrogenic anal sphincter injury is most common in males.      Loperamide (imodium) is a constipating agent used as first choice pharmacological agent due     to its high efficacy. Trials have suggested it thickens stool consistency and may raise     resting anal sphincter pressure, associated with improved clinical function with a reduction     in bowel frequency and urgency, a reduction in incontinence and less need for pads.      Loperamide is well tolerated but has been known to cause side effects of abdominal pain and     distension, nausea and vomiting and constipation.      Imodium can be taken in two ways; as syrup (1mg/5mls) or tablets (2mg). There have been no     comparative studies. Side effects are mainly seen with the tablet form and so it is     hypothesized that the syrup form is better tolerated because it is more accurately titrated     to effect.      This is a NHS funded single blinded, randomised, cross-over study to assess the clinical     effects of Imodium, in tablet and syrup form, on patients presenting with faecal     incontinence. Each subject will act as their own control. Patients will be recruited through     out-patient visits for their FI, where they will be made aware of the trial. During the trial     they will be asked to fill out FI scoring questionnaires and quality of life scores. Also     they will undertake two assessments of anal physiology testing squeeze pressures, sensation     and compliance at baseline and at the end after three months.   "
235671|NCT00933478|"     The Eustachian tube is a tube that connects the back of the nose with the ear. Its job is to     keep the pressure on the inside of the eardrum close to the pressure outside the eardrum, so     that the eardrum can vibrate properly. Usually this tube is closed, but it opens briefly     during swallowing. In the condition called patulous eustachian tube, this tube is open all     the time. This is a benign condition but it can be very bothersome to patients.      The incidence of patulous Eustachian tube dysfunction is about 0.3-6.6% of the population.     However, about 15% of the people who have this condition are bothered enough by it that they     seek medical attention. This condition is more common in females than males and is more     common in adults than children.      Some of the common symptoms of patulous eustachian tube can include roaring tinnitus     synchronous with nasal respiration, audible respiratory sounds, sensation of a plugged ear     and fluctuating aural fullness.      In most cases the cause is idiopathic. Some predisposing factors include weight loss,     stress,anxiety,fatigue, pregnancy, and temporomandibular joint syndrome. It can also be     caused by adhesions in the nasopharynx following surgery on the adenoids. Sometimes it can be     associated with medications such as diuretics and oral contraceptives. Neuromuscular     disorders that cause atrophy such as multiple sclerosis, stroke and motor neuron disease have     also been postulated to cause patulous eustachian tube.      The purpose of this trial is to learn more about the condition and help us learn about how     the eardrum might be treated to prevent it vibrating with sounds or noises coming up the     Eustachian tube.      The first part of the study will consist of a questionnaire to help to further define the     symptoms of patulous eustachian tube, and to measure how severe these symptoms are.      Currently there are few treatments that are satisfactory for patients. Common surgical     therapies include injections of various substances into the Eustachian tube opening including     paraffin, Teflon,or gelfoam. Unfortunately, these methods are either temporary or have lead     to serious complications including cerebral thrombosis and death (due to inadvertent     injection into the carotid artery). Other treatments have focused on cauterizing the     Eustachian tube opening but these have been either unsatisfactory or caused damage to the     trigeminal nerve. Myringotomy and insertion of a ventilation tube has helped some patients     but others have found that this increased the patient's discomfort.      The investigators have been treating patients recently by placing some putty like clay     material on the eardrum, which stops it vibrating so much with the patient's own voice, and     this appears to be quite effective for many patients. It is also easily removed if the     patient does not find it helpful. However, the investigators do not really have a good idea     of exactly which patients are helped by this, and which are not, and just how much their     symptoms are helped, as well as how long the treatment helps them for.   "
235672|NCT00933491|"     Dental implants are regarded as a standard of care in restoring missing teeth. Although there     is a high prevalence of diabetics who receive dental implants, the relationship between     dental implants and diabetes has not clearly been investigated.      A total of 32 subjects (14 patients with type II diabetes and 18 non-diabetes subjects) who     have dental implants were recruited. The purposes of this research study were: (1) to     evaluate diabetes patients to determine risk factors for bone loss at dental implants and     teeth; and (2) to evaluate bone-resorptive biomarkers (proteins related to bone loss) present     in saliva and blood serum, comparing the two groups.   "
235673|NCT00933504|"     Primary Objective:      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated     dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFL.   "
235674|NCT00933517|"     The purpose of this study is to assess the pathological response rate in operable breast     cancer patients treated by neoadjuvant combination: FEC-Taxotere/Vectibix.   "
235675|NCT00933530|"     The purpose of this study is to determine the safety and tolerability of SRT2104 (0.03, 0.1,     0.25, 0.5, 1.0, 2.0, and 3.0 g/day) in healthy male volunteers when administered after a     single dose and once daily for 7 consecutive days.      The purpose is also to characterize the pharmacokinetic profile of SRT2104 (0.03, 0.1, 0.25,     0.5, 1.0, 2.0, and 3.0 g/day) after a single dose and multiple administrations in healthy     male volunteers.   "
235676|NCT00933543|"     The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from     9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream     without occlusion and red light(dose: 37J/cm2)   "
235677|NCT00933556|"     The purpose of this study is to investigate the feasibility, safety and efficacy of oral     probiotic, VSL#3 versus oral placebo for reducing colonization by VRE.   "
235678|NCT00933569|"     Primary Objective:      To prove the safety of the gynaecological formulation in normal conditions of use.   "
235679|NCT00933582|"     The purpose of this single-center study is to evaluate the potential analgesic effects of a     single oral dose (50 mg) of JNJ-39439335, an investigational drug being developed for the     treatment of pain in patients with chronic osteoarthritis pain of the knee. The study will     also evaluate the pain treatment response assessments and methods being used in this study.     Participants will also take naproxen (500 mg) and placebo (an inactive substance) during the     study. Pain assessments after taking JNJ-39439335, naproxen and placebo will be compared.   "
235680|NCT00933595|"     The Lung HIV goal is to facilitate the data and specimen collection efforts of eight     individual HIV and pulmonary studies that operate under the direction of the NHLBI. The Lung     HIV study will build on existing studies to facilitate the start-up of new projects to     further the understanding of the relationship between pulmonary disease and HIV infection.     There is only one clinical trial being performed in this network at Ohio State University and     it will be reported here.   "
235713|NCT00934037|"     The purpose of this study is to evaluate the diagnostic accuracy of multi-detector computed     tomography using 320 detectors for identifying the combination of coronary artery stenosis ≥     50% and a corresponding myocardium perfusion defect in a patient with suspected coronary     artery disease compared with conventional coronary angiography and single photon emission     computed tomography myocardium perfusion imaging.   "
235714|NCT00934050|"     The purpose of this study is to evaluate the long-term safety and tolerability of ELND005     beyond the 18 months of treatment in original randomized and blinded clinical trail     ELND005-AD201.   "
235715|NCT00934063|"     This observational study is conducted in Europe. The aim of this observational study is to     investigate the changes in a score (GET-score) which includes quality of life, body     composition and cholesterol metabolism in patients on growth hormone treatment. The GET score     stands for: Growth hormone deficiency and Efficacy of Treatment, and is a quantitative     measurement of the efficacy of the treatment with growth hormone in adults.   "
235681|NCT00933608|"     Recent data show that marked cell damage precedes the clinical manifestation of Alzheimer's     disease (AD). Hence, targeting populations at risk with pharmacological interventions is a     possible strategy to lessen the burden of the disease. Cognitively normal individuals with     subjective memory complaints (SMC) manifest biological characteristics consistent with early     AD and are at risk for future cognitive decline. Family history of AD also constitutes a     risk. In a previous study the investigators showed that memantine slows down the accumulation     of phosphorylated tau in normal SMC subjects. Using a multivoxel high field MR spectroscopy     (MRS) technique, the investigators also demonstrated that memantine decreased hippocampal     glutamate. Both these findings may be consistent with the drug's anti-excitotoxic activity.     In this new project the investigators propose to treat a sample of 12 presymptomatic     individuals at risk (SMC and family history of AD) with memantine. This will be a double     blind, placebo controlled study with a control group (12 non-treated subjects). The     investigators will determine whether the effects of memantine as assessed by cognitive     performance and MRS are present after 4 months of treatment and persist 2 months after     discontinuation. MRS will be used to evaluate the effect of memantine on levels of the     neurotransmitter glutamate and neuronal viability marker N-acetylaspartate (NAA) in the     hippocampus. The investigators will test the following hypotheses:        1. In subjects with SMC, memantine has modifying effects on brain biochemistry as reflected          in MRS reductions in glutamate (reduced excitotoxicity) and increases in NAA (neuronal          integrity).        2. The effects of the drug persist (as a marker of sustained neuroprotection) and can be          measured 2 months after discontinuation of the treatment.   "
235684|NCT00933647|"     The investigators aim to study the effects of green tea and maté consumption on lipid and     inflammatory profiles in dyslipidemic and overweight subjects.   "
235685|NCT00933660|"     The hypotheses that will be studied are:      H0: Providers trained by a web based application for skill competency in basic life support     (BLS) and automated external defibrillation (AED) are as competent as those who were trained     by certified instructors using the European Resuscitation Council (ERC) curriculum      H00-1: Providers who trained themselves with the used of web based training are more     competent when they had a personal manikin for home exercise compared to providers who     trained themselves with only a web based training      H0-2: Providers who did not receive any training will score lower than those who did.      Research questions for this study are:        1. What are the results in skill competency for non trained people?        2. What are the results in skill competency for trained people immediately after training?        3. What is the retention of skills for trained and non trained people after six months?   "
235686|NCT00933673|"     The purpose of this study is to evaluate the efficacy and tolerability of the combination     chemotherapy of L-asparaginase plus DICE regimen in the patients with early stage NK/T-cell     lymphoma.   "
235687|NCT00933686|"     The purpose of this study is to evaluate the efficacy of recombinant human growth hormone     (r-hGH) treatment in severe fibromyalgia subjects with growth axis dysfunction.   "
235688|NCT00933699|"     Primary Objective:      To prove the safety of the gynaecological formulation in normal conditions of use.   "
235689|NCT00933712|"     Primary Objective:      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated     dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Floral   "
235690|NCT00933725|"     The purpose of this multiple-centered, randomized, controlled study is to investigate the     efficacy and safety of a combination using herbs prescription and traditional Chinese     medicine (TCM) emotion treatment in women with menopausal syndrome.   "
235691|NCT00933738|"     This is a multi-center study designed to evaluate the heparin insensitivity of the INRatio     Prothrombin Time (PT) Monitoring System, utilizing an INRatio test strip additionally     modified for low sample volume. The INRatio test strip is used for the quantitative     determination of PT and International Normalized Ratio (INR) results in fingerstick blood     from subjects on oral anticoagulation therapy (OAT) with warfarin. This study is designed to     evaluate the accuracy of the modified INRatio test strip during heparin-warfarin bridge     therapy with unfractionated heparin (UH) or low molecular weight heparin (LMWH), such as     enoxaparin or dalteparin. These INR results will be compared to the INR results obtained on     plasma from the same subjects as analyzed at a central laboratory with the     heparin-insensitive reference method: the Sysmex CA-560 System. The levels of UH or LMWH in     the plasma samples will be assessed using activated partial thromboplastin time (aPTT) and     anti-factor-Xa assays respectively.   "
235692|NCT00933751|"     Tissue hypoxia is one of the most important factors leading to the development of multiorgan     failure. Patients presenting for emergent major abdominal surgery might suffer from organ     hypoperfusion. Thus, early detection of the imbalance between oxygen supply and demand may     improve the outcome. The investigators believe that hypoperfusion of the abdominal organs     will cause a decrease of the saturation in the hepatic vein and in the IVC.   "
235693|NCT00933764|"     This is a multi-center study designed to assess the accuracy and precision of the Cholestech     LDX Cardiac hsCRP test for the quantitative determination of C-reactive protein (CRP) in     whole blood, serum and plasma from individuals being assessed for risk of cardiovascular     disease. The Cholestech LDX Cardiac hsCRP test consists of the CRP cassette and LDX analyzer     and measures CRP with high sensitivity on fingerstick or venous whole blood at the     point-of-care (POC). The results of this study are intended to be used for regulatory 510k     filings for use as an in vitro diagnostic test.   "
235694|NCT00933777|"     Dose finding part: A phase I clinical trial to evaluate the safety of combined sorafenib and     everolimus treatment in patients with relapsed solid tumors (finished).      Extension part:Treatment of non-small cell lung cancer (NSCLC) with KRAS mutation after ≥ 1st     relapse (recruiting)   "
235716|NCT00934076|"     The purpose of this study the safety and effectiveness of oral AT-101 when given with the     standard dose of erlotinib (Tarceva)to patients who are older that 18 and who have advanced     non-small cell lung cancer, who have relapsed or progressed on prior platinum-based     chemotherapy.      It is proposed that the effects of AT-101 may improve the clinical benefit of erlotinib in     patients with advanced NSCLC.   "
238511|NCT00970060|"     The purpose of this study is to describe the effect of a 10-week exercise program on nerve     function and number of nerve fibers in the skin in the lower leg in people with diabetic     neuropathy.   "
235695|NCT00933790|"     Acquired Rifampicin Resistance has emerged as an important issue in the treatment of HIV-TB     patients. It has not been a major problem in HIV-negative individuals treated for TB treated     with standard intermittent regimens. The study would generate data on the efficacy of daily     and thrice weekly regimen of ATT in pulmonary TB patients with HIV in the presence of highly     active antiretroviral therapy (HAART). Not many trials have compared sputum conversion and     adverse drug reaction between daily and intermittent regimens of ATT in HIV positive     patients. This study provides a unique opportunity for comparison of daily and intermittent     therapy for HIV patients with pulmonary TB looking into multiple dimensions of HIV-TB     treatment namely efficacy, drug resistance, toxicity , drug interaction and immune     reconstitution inflammatory syndrome. The primary outcome of the study is to compare the     efficacy of three anti-TB regimens in a) reducing bacteriological failures and b) decreasing     the emergence of Acquired Rifampicin Resistance (ARR). The secondary outcomes include     unfavourable responses (clinical failures, deaths, relapses) as whole, treatment emergent     adverse drug reactions, pharmacokinetic levels of ATT and incidence of immune reconstitution     syndrome.   "
235696|NCT00933816|"     The purpose of this study is to determine the recommended dose of the combination therapy of     sorafenib with hepatic arterial infusion of low dose cisplatin and fluorouracil on patients     with advanced hepatocellular carcinoma (Phase I), and to evaluate the efficacy of this     combination therapy in the recommended dose (Phase II).   "
235697|NCT00933829|"     The primary objective of this prospective, randomized study is to compare cosmetic outcomes     between absorbable and non-absorbable sutures in truncal and extremity lacerations in the     pediatric and adult population. Secondary outcome measures include wound complications such     as infection and wound dehiscence at the initial visit; and parental satisfaction and keloid     formation after three months post repair.   "
235702|NCT00933894|"     The purpose of this study is to investigate the effect of steady-state telaprevir (TVR) 750     mg q8h (3 times a day, every 8 hours) on the steady-state pharmacokinetics of escitalopram 10     mg q.d. (once a day), and vice versa. Steady state is a term which means that the drug has     been given long enough so that the plasma concentrations will remain the same with each     subsequent dose. TVR is being investigated for the treatment of chronic hepatitis C virus     (HCV) infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream,     distributed in the body and eliminated from the body.   "
235703|NCT00933907|"     Primary Objective:      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated     dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFR.   "
235704|NCT00933920|"     The purpose of this study is to determine the effect of a light meal on the pharmacokinetics     and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.   "
235705|NCT00933933|"     To test blood specimens using a new investigational test that detects antigen and antibody to     human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test     and supplemental testing performed to determine HIV status.   "
235706|NCT00933946|"     Primary Objective:      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated     dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Frutal.   "
235707|NCT00933959|"     The aim of the proposed pilot study is to scientifically evaluate the use of Mind-Body     Bridging Program (MBBP) as an effective intervention for improving health outcomes in     veterans exhibiting sleep disturbance in the Primary Care Clinic at the Veterans     Administration Salt Lake City Health Care System (VASLCHCS).   "
235708|NCT00933972|"     This 4 arm study will investigate the pharmacodynamics and pharmacokinetics of RO4998452 in     type 2 diabetes patients with varying degrees of renal impairment. Eligible patients will be     divided into 4 groups, with normal renal function, or mild, moderate or severe renal     impairment. All patients will receive a single oral dose of RO4998452 in the fasted state.The     anticipated time on study treatment is <3 months (single dose study)and the target sample     size is <100 individuals.   "
235709|NCT00933985|"     This phase I trial is studying the side effects and best dose of obatoclax mesylate when     given together with vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane     hydrochloride in treating young patients with relapsed or refractory solid tumors, lymphoma,     or leukemia. Obatoclax mesylate may stop the growth of cancer cells by blocking some of the     proteins needed for cell growth and causing the cells to self-destruct. Drugs used in     chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Giving obatoclax mesylate together with     combination chemotherapy may kill more cancer cells.   "
235710|NCT00933998|"     The purpose of this research study is to determine if Metanx improves sensory neuropathy in     persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a     physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which     are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be     assigned to receive Metanx for 12 months. Baseline quantitative sensory testing will be done     before the patient receives Metanx. Additional quantitative sensory testing will be done at 6     and 12 months to evaluate.   "
235711|NCT00934011|"     In this study the investigators aim to test if C-reactive protein (CRP)or procalcitonin(PCT)     - guided strategy allows to reduce the antibiotic use in patients wiht severe sepsis and     septic shock. Therefore, the safety of this intervention will be carefully measured.   "
235719|NCT00934115|"     Infections are common causes of morbidity and mortality in pediatric cancer patients. Today,     there are limited data on the incidence, distribution of specific infections, causative     agents and risk factors for severe infections in this population. Moreover, little data exist     on the epidemiology of infections among pediatric patients with solid tumors.      The objectives of the present study are to define the incidence, categories of infections by     organ systems, etiologic agents and risk factors for infections in different pediatric     malignancies. The results of this study will help the investigators to better understand the     epidemiology of infections in the different types of pediatric malignancies, enable the     investigators to identify high risk patients, and design a better approach to empiric     treatment of these patients.      A prospective, multi-center study, conducted in 5 pediatric hematology-oncology units across     Israel (Rambam Medical Center, Haemek Medical Center, Schneider Children's Medical Center,     Hadassah Medical Center, Soroka Medical Center). All children aged 0-18 years of age, newly     diagnosed with cancer and admitted to day care or inpatient departments with fever of >38.0 C     will be included in the study. Demographic, clinical and microbiological figures will be     collected in each center by a research assistant supervised by the infectious disease     specialist. Data will be collected according to a pre-defined Patient Data Form and entered     into an electronic data base that will be analyzed accordingly. In each event of febrile     episode during chemotherapy, the following data will be collected by a research assistant     using a patient data form and computerized software:        -  Demographic data: age, gender, ethnicity.        -  Clinical data: Underlying disease, immunizations, prophylactic antibiotics, presence of          central venous catheter, intensity of chemotherapy, duration of fever, duration and          severity of neutropenia, diagnosis of present event.        -  Imaging data        -  Microbiological data        -  Outcome      The statistical analysis will be performed by an epidemiologist and statistician using the     SPSS 12.0 software.   "
235720|NCT00934128|"     The goal of this clinical research study is to learn if specialized breathing devices reduce     the sensation of shortness of breath in patients with advanced cancer who are experiencing     shortness of breath. Researchers want to learn if these devices can help to control shortness     of breath.      The 2 devices being tested and compared are called BiPAP (bilevel positive airway pressure)     and Vapotherm.   "
235721|NCT00934141|"     Addiction treatment is often characterized by long delays between first contact and treatment     as well as high no-show and drop out rates leading to unused capacity in apparently full     agencies. Patients do not get needed care and agency financial stability is threatened. The     Network for Improvement of Addiction Treatment (NIATx) began as a high-intensity improvement     collaborative of 39 addiction treatment agencies distributed across 25 states. NIATx     substantially improved time to treatment and continuation in treatment by making improvements     to organizational processes (such as first contact, intake and assessment, engagement, level     of care transitions, paperwork, social support, outreach, and scheduling) in preliminary     studies. While the results are very encouraging, they have, by intent, been obtained from a     select group of agencies using a high-cost combination of services. A more practical     diffusion model is needed to spread process improvements across the spectrum of treatment     agencies. This study is a cluster-randomized trial to test the effectiveness and cost of less     expensive combinations of the services that make up the NIATx collaborative (interest     circles, coach calls, coach visits and learning sessions).   "
235722|NCT00934154|"     This is a multi-centre Phase III randomized controlled study of patients with multiple     myeloma (MM). Eligible patients who are not candidates for transplantation will be randomized     to receive eight courses of Melphalan/Prednisolone with or without Thalidomide treatment.     Thalidomide will be initiated at the dose of 100 mg/day and maintained at 100 mg/day. The     patients will be assessed for any responses at the end of 2nd, 4th, 6th and 8th cycles of     treatment. The toxicities will be assessed at monthly intervals. Patients will be assessed     for the:        1. Incidence and grade of any toxicity        2. Level of maximum disease response        3. Time to disease progression        4. Time to death   "
235723|NCT00934167|"     The aim of this study is to verify, through clinical examination and doppler, the     non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to     the drug compared (heparin sodium 5.000USP/mL - APP) in preventing the development of venous     thromboembolism (VTE) in patients undergoing surgery for medium risk for the development of     this pathology.   "
235724|NCT00934180|"     The objective of this study was to compare the relative bioavailability of the test     formulation of Ondansetron HCl with the already marketed reference formulation Zofran ODT     under fasting conditions in healthy, non-smoking adult subjects.   "
235725|NCT00934193|"     The primary objective of this study is to determine if gabapentin can decrease or prevent     chronic post-thoracotomy pain.   "
235726|NCT00934206|"     Physical exercise elicits beneficial changes in the body. These concern physical performance     but also improvements in virtually all known risk factors for cardiovascular disease. Yet,     the extent of individual benefit differs considerably even within homogenous groups and the     prediction of individual training effectiveness is not yet possible. This study aims to find     predictors of individual training effectiveness.   "
235727|NCT00934219|"     Lovaza is a special fish oil concentrate, that prescribed at 4 g a day to reduce certain fat     (triglycerides) levels in blood.Our goal is to study how Lovaza at doses of 4, 8, and 12     grams per day will reduce fats in the blood of the patients with very high level of     triglycerides. Our hypothesis is that patients with very high triglycerides will respond more     with higher doses of Lovaza (8 g per day and then 12 g per day).   "
235728|NCT00934232|"     Two main objectives of the study are:      Primary:      To determine the MTD of Busulfex ® that can be given safely over the least number of days to     myeloma patients who are either ≥65 years of age (Group 1) or have renal insufficiency (Group     2), defined as creatinine >3mg/dL or creatinine clearance <30 mL/min.      Secondary:      To perform pharmacokinetic (PK) studies to evaluate individual variability and the     relationship to toxicities in each of the two groups at each proposed dose level.   "
235729|NCT00934245|"     The study described here will immunize children with trivalent influenza vaccine (TIV) and     determine whether this reduces influenza illness among the immunized children and their older     family members. The comparison or control group for the children receiving influenza vaccine     will be children immunized with inactivated poliovirus vaccine (IPV). The study will also     provide information on the amount of disease produced by influenza in the study population.   "
235750|NCT00934518|"     The standard treatment for head and neck cancer relapses in previously irradiated patients is     controversial. Reirradiation has had some success, but many patients still die from their     disease. Cetuximab is helpful in relapsed head and neck cancer, and it improves the     effectiveness of radiation in some head and neck cancer patients. But, it has not been     studied with reirradiation. The purpose of this study is to see the effects, both good and     bad, of reirradiation with cetuximab.   "
238672|NCT00979940|"     This research study plans to evaluate the use of atorvastatin in patients with coronary     artery disease given immediately before PCI and whether it will decrease the amount of heart     damage after PCI.   "
235730|NCT00934258|"     Previous studies indicate that the variant status of detoxification proteins is different     among Taiwanese and other ethnic groups. For example, in Taiwanese, the major SNPs of CYP2C9     are CYP2C9*2 (430C>T) and CYP2C9*3 (1075A>C) and their frequencies are different from that in     Caucasians [11]. The second example is that the frequency of the A(TA)7TAA allele in the     promoter area of the UGT1A1 gene is substantially lower, while for the rate of variation     within the coding region is much higher in Taiwanese than that in Caucasians (14.3% vs. 35.7-     41.5% and 29.3% vs. 0.1%, respectively) [12]. The third example is that the frequency of     388A>G of the OATP2 gene in Taiwanese (0.68) [13] is in between that in European Americans     (0.30) and African Americans (0.74) [14]. Therefore, the investigators hypothesize that, in     Taiwanese the SNPs of detoxification proteins modulate the lipid-lowing effects of RVA and     fenofibrate may be different from those for Caucasians.   "
235731|NCT00934271|"     Hypothesis: Fractionated stereotactic radiotherapy is a safe therapy for treatment of     patients with acromegaly in terms of both tumour control and biochemical remission   "
235732|NCT00934284|"     The purpose of this study is to determine if participation in physical therapy in conjunction     with a selective nerve root block in the lumbar spine is more effective than just receiving     the injection alone for patients with low back and leg pain from a disk herniation     (sciatica).   "
235733|NCT00934297|"     Magnetic resonance imaging (MRI) is commonly used for the detection of breast lesions in     genetically high-risk women due to its high sensitivity. As non-cancerous conditions     including normal changes due to a woman's menstrual cycle may have the appearance of cancer     on MR images, a biopsy (generally performed under ultrasound-guidance) of the suspicious mass     is required for definitive diagnosis. However, only a limited percentage of MRI-visible     lesions are also visible on ultrasound (US). Even if found, it is often unclear whether the     lesion identified on US corresponds to the MRI-detected lesion in question. The investigators     have developed a visualization tool to assist the visualization of MRI-detected lesions in     US-guided procedures (e.g., biopsy). This tool provides a simultaneous display of the     previously acquired MRI data alongside real-time US images. The investigators propose a pilot     study to assess the usefulness of this tool in identifying MRI-detected lesions using     real-time US-guidance.   "
235911|NCT00942422|"     RATIONALE: Green tea extract contains ingredients that may prevent or slow the growth of     monoclonal gammopathy of undetermined significance and/or smoldering multiple myeloma.      PURPOSE: This phase II trial is studying how well green tea extract works in treating     patients with monoclonal gammopathy of undetermined significance and/or smoldering multiple     myeloma.   "
235734|NCT00934310|"     In January of 2007, the World Health Organization's (WHO) World Alliance for Patient Safety     initiated a project called Safe Surgery Saves Lives to identify minimum standards of     surgical care that can be universally applied across countries and settings. Through a two     year process involving international input from surgeons, anesthesiologists, nurses,     infectious disease specialists, epidemiologists and others, the WHO created a surgical safety     checklist that encompasses a simple set of surgical safety standards that can be used in any     surgical setting. Each safety step on the checklist is simple, widely applicable, and     measurable. The Surgical Safety Checklist was piloted in 8 hospitals around the world and     results demonstrated a significant decrease in death rate and postoperative complications.      This study proposes to introduce an adaptation of the Surgical Safety Checklist for an     ambulatory care surgical program and to assess the efficacy of its adaptation and     implementation on staff safety attitudes and patient outcomes. Specific ambulatory-based     items will be included in the checklist and patient outcomes will be assessed using the     Institute for Health Improvement's Perioperative Surgical Outcomes Tool which will also be     adapted for use for the ambulatory setting as well as routine follow up phone calls with     patients on the 1st postoperative day.   "
235735|NCT00934323|"     The pharmacokinetics of glimepiride and metformin will be compared after single dose intake     of both combinations in order to answer to the following questions:        -  Is there a dose proportionality effect between Amaryl M SR 1/500 mg and Amaryl M SR          2/500 mg?        -  What is the safety profile of Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg?   "
235736|NCT00934336|"     The aim of this study is to determine whether postprandial hyperglycaemia plays an important     role in oxidative stress phenomena and influences their harmful effects on the arterial wall.      25 type 1 diabetic patients practicing FIT and with an HbA1c value of 8 percent or less at     the beginning of the study will be recruited. The 25 control subjects will be recruited after     the patients, so that they can be paired by age and sex.      Patients will be randomized via an alternative cross over study design for 2 periods of 3     months, i.e. preprandial or postprandial injection of an ultra fast acting analog. During the     6 months of the study, slow acting analog doses will be adjusted on the basis of basal     glycaemia values. The fast acting analog doses will be adjusted on the basis of an optimized     algorithm available on each patient's PDA phone electronic diary.      Blood and urine samples will be collected at M0, M3 and M6 to evaluate the stress oxidant     grade and its consequence on atherogenesis:      Oxidative Stress evaluation: plasma parameters (lipid peroxide derivatives, semicarbazide     sensitive oxidase amine activity), erythrocyte and leukocyte cell parameters (reduced and     oxidised glutathion, dismutase superoxide activity (SOD) Cu and Mn dependent, glutathion     peroxidase, and catalase), urinary parameters (isoprostane F2) Evaluation of consequences of     oxidative stress on atherogenesis processes: inflammatory parameters (CRP, TNFa, IL 6),     adhesion molecules (VCAM 1, ICAM 1, P selectine), adipokines (leptine, resistine,     adiponectine), coagulation factors (PAI 1), platelet and endothelial microparticles, The pre     and postprandial glycaemic stability of each patient will be monitored using PDA phone     systems, and HbA1c will be measured at M0, M3 and M6.      Expected results and outcomes:      It is important to know if, in patients with comparable glycaemic stability, these two     insulin treatment regimens are associated with significant differences in oxidative stress     and anti oxidant defenses.      These results may help us to define a postprandial insulin treatment regimen (which is more     flexible as regards meals) or a preprandial insulin treatment regimen (less flexible for     meals but maybe less harmful in terms of limitation of oxidative stress).   "
235737|NCT00934349|"     The purpose of this study is to assess the existence of a genetic factor, suspected to be     involved, aside from likely food deficiency contribution, in occurrence of dry beriberi, in     patients who experienced dry beriberi and in a case group composed of 3 people, free from     beriberi, within the same household.   "
235738|NCT00934362|"     Mucus clearance is impaired in cystic fibrosis. Inhaled surfactants may reduce adhesive     forces between mucus and airway surfaces and improve mucus clearance. This in turn my improve     lung health. The investigators propose to measure mucus clearance before and after     lucinactant or vehicle administration in patients with cystic fibrosis.   "
235739|NCT00934375|"     This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive     Impairment who have completed the double-blind study (E2020-A001-412).   "
235813|NCT00935350|"     Reductions of postprandial glucose levels have been demonstrated previously with the addition     of a novel viscous polysaccharide (NVP) to a glucose drink and standard white bread. This     study explores whether these reductions are sustained when NVP is added to a range of     commonly consumed foods.   "
235814|NCT00935363|"     The purpose of this study is to investigate if the drugs rifampin and fluconazole when given     together increase the concentrations in the body of the oral diabetes medication glyburide.   "
235740|NCT00934388|"     Chronic groin pain is a frequent cause for referral to general surgeons. In some cases this     pain may be due to the presence of a hernia. However, if on clinical examination there is no     palpable lump or bulge, the cause of the pain may be difficult to elucidate. Some of these     patients may have the diagnosis of sportsman's groin. Other names which have been attached to     this condition include Gilmores groin and sportsmans hernia. These conditions are more     commonly associated with sportsmen and women but those who do not play sport may also receive     this diagnosis. Sportsman's groin is thought to be a syndrome of weakness of the posterior     inguinal wall without a clinically recognisable hernia. Differing explanations for     sportsman's groin include avulsion of the conjoint tendon from the pubic tubercle, weakening     of the transversalis fascia, tears in the internal or external oblique, superficial inguinal     ring dilatation and abnormalities of the rectus abdominus insertion.      There is some evidence that pre peritoneal mesh placement in these patients may be     beneficial. The theory being that the mesh prevents pressure transmission to the damages     structures, allowing them to heal more rapidly.      Aim. To assess the potential benefit of pre peritoneal mesh placement using the TAPP     technique in patients with chronic groin pain.   "
235741|NCT00934401|"     Positron Emission Tomography Imaging with 3-Deoxy-3'-[18F]Fluorothymidine (FLT) can     selectively identify proliferating and non-proliferating tissues, including tumors. FLT     uptake in the tumor is an indirect marker of DNA synthesis activity, which is a target of     chemotherapy. Our hypothesis is that early change in FLT uptake in tumor with chemotherapy     will predict pathological response to neoadjuvant therapy in breast cancer. Tumor uptake of     FLT will be imaged and measured with positron emission mammography (PEM), a PET scanner     optimized for breast imaging with a significantly improved resolution compared to     conventional whole-body PET imaging systems.   "
235742|NCT00934414|"     Twelve smoking and twelve non-smoking subjects with Type 2 Diabetes Mellitus will be enrolled     in this study to determine the effect of Technosphere® Insulin Inhalation Powder on insulin     in the body during a clamp procedure.   "
235743|NCT00934427|"     The purpose of this study is to determine if Vascana, a novel topical formulation of     nitroglycerin, is effective in the treatment and prevention of the symptoms associated with     Raynaud's Phenomenon.   "
235745|NCT00934453|"     This study is a single site, Phase I, masked, randomized study to evaluate the safety and     tolerability of twice daily dosing of LGG (Lactobacillus GG ATCC 53103) in normal healthy     adult volunteers. Study drug capsules (1x10^10 LGG/capsule or placebo) will be taken by mouth     twice a day with cow's milk or soy milk on an outpatient basis. Volunteers will have study     visits at baseline, 1 month, 3 months, 6 months, 7 months, and 12 months where they will be     asked about any medical problems that have come up since the last study visit, have vital     signs taken, review current medication use, and review any signs of potential adverse events.     Blood and urine samples will also be collected at these visits, as well as throat and stool     samples.      Our goal is to assess the safety and tolerability of LGG when administered to healthy adult     volunteers twice a day. Assessment of safety will be determined by vital sign measurements,     physical examinations, clinical laboratory tests, and from the incidence and severity of     adverse events that occur during study participation. Additionally, we will assess whether     LGG colonizes the throat and/or gastrointestinal tract of healthy adult volunteers and assess     the effect of LGG on the bacteria that normally live in the throat and GI tract by using     culture-independent techniques. Volunteers enrolled in this study will also be invited to     participate in a companion genetic study that will investigate the host immune response to     the bacteria in LGG.   "
235746|NCT00934466|"     This study will assess transcranial magnetic stimulation (TMS) as a biomarker and     characterize TMS readouts of the activity of MK2637 and dextromethorphan. Resting     quantitative electroencephalography(qEEG) readouts are also characterized with MK2637 and     dextromethorphan.   "
235747|NCT00934479|"     The purpose of this study is to determine whether the bacteria normally present in the bowels     are different in people with constipation and to see what effect the treatment with the Food     and Drug Administration (FDA) - approved drug, lubiprostone, has on these bacteria.   "
235748|NCT00934492|"     This trial aims to test the hypothesis that mortality among Kenyan children with severe     malnutrition following initial stabilisation is due to ongoing vulnerability to infectious     disease, and that long term daily co-trimoxazole prophylaxis will reduce mortality.      The objective is to conduct a randomized, double blind, placebo-controlled trial of     cotrimoxazole prophylaxis for 6 months among HIV-uninfected children with severe malnutrition     following stabilization. The primary outcome will be survival at one year. Secondary outcomes     are toxicity, growth, the frequency and causes of hospitalisation and microbial resistance to     antibiotics.      Cotrimoxazole has striking protective efficacy against mortality among children with HIV,     despite not altering the underlying immune deficiency. It is hypothesised that co-trimoxazole     prophylaxis will have a similar effect in children immunocompromised because of severe     malnutrition. Worldwide, severe malnutrition is commoner than HIV in childhood and     co-trimoxazole is cheap and widely available, making it easily translatable to policy.   "
235749|NCT00934505|"     The poor prognosis in the early-stage of oesophageal carcinoma cancer is due to potential     worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity     of actual treatments.      FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose     consumption. Then, this exam is used for pathology staging, target volume definition for RT,     and treatment efficiency few months after CRT. Our assumption is that an FDG-PET exam during     the course of CRT might be predictive of the treatment efficiency few months later.      In this study, we propose to perform 4 FDG-PET: first PET1 before chemo-radiotherapy,     second PET2 during the chemo-radiotherapy (see RTEP1), third and fourth PET3 PET4     3month and 12 month after the end of radiotherapy.      We will investigate the performances of FDG-PET performed during CRT for the prediction of     the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, we would be     able to optimize the planning treatment during the course of the therapy.   "
238673|NCT00979953|"     The purpose of this study is to determine the efficacy of ADL5859 versus placebo and ADL5747     versus placebo in relieving pain in participants with osteoarthritis of the knee.   "
235751|NCT00934531|"     Compared with cognitively normal older adults, those with mild cognitive problems (MCI) have     a two-fold higher rate of falls, sustain more fractures, and have a higher rate of mortality     due to falls. Why older adults with cognitive problems fall more frequently is not completely     understood. What is known, however, is that attention is a necessary cognitive resource for     normal walking and impairments in attention are associated with increased risk of falls in     older adults.      It has been suggested that cholinesterase inhibitors (ChEI), medications used for treatment     of dementia, may improve motor function and walking (gait performance). Since ChEI are known     to improve attention, we hypothesized that ChEI will reduce falls risk in people with MCI by     improving their gait velocity, improving their balance, and reducing their gait variability;     a well-established risk factor for falls.      In the proposed study, we will evaluate the effect of donepezil (ChEI) on gait velocity, gait     variability, and the balance on 140 elderly individuals with MCI (70 intervention and 70     controls). Gait variables will be measured using an electronic walkway, and balance     confidence using a validated scale (Activities-Specific Balance Confidence Scale; ABC) over     four months.      By characterizing and understanding the effects of cognitive enhancers on fall risk in older     adults with cognitive impairments, we will be able to pave the way for a new approach to fall     prevention in this population. We would establish that medications that augment cognitive     function could be a complementary therapeutic option for reducing fall risk in people with     MCI. This may lead to new approaches to prevent and treat fall risk in this population, which     will lead to improve the autonomy and quality of life of seniors in early stage of dementia,     and a decreased burden for the Ontario health care system.   "
235752|NCT00934544|"     This is an open label, randomized study comparing the efficacy and safety of randomized 2:1     INC424/INCB018424 tablets versus best-available therapy, as selected by the investigator. The     purpose is to compare the efficacy, safety and tolerability of INC424/INCB018424 given twice     daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post     polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis     (PET-MF).   "
235778|NCT00934882|"     This multi-center, open-label, non-randomized, non-placebo-controlled, Phase I study will     define the safety profile and tumor response profile of the multi-kinase inhibitor BAY73-4506     as oral treatment in combination with the chemotherapy regimen mFOLFOX6 or FOLFIRI in     patients with metastatic CRC. It will also determine the impact of the combined     administration on the concentration of drugs over time (pharmacokinetics) of BAY73-4506,     oxaliplatin, 5 FU, and irinotecan.      This study will be conducted at approximately 5 - 8 study centers in Germany. Up to 60     patients will be enrolled into this study to ensute that at least 12 - 15 patients for each     combination regimen can be evaluated for safety and pharmacokinetics. For this reason a     minimum of 20 patients will receive mFOLFOX6 in combination with BAY73-4506 and at least 20     patients will receive FOLFIRI in combination with BAY73-4506.   "
236774|NCT00947063|"     To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under     fasting conditions.   "
235753|NCT00934557|"     Paediatric patients affected by haematological malignancies and eligible to undergo HSCT from     an unrelated volunteer will be stratified according to the degree of compatibility with their     donor, the source of haematopoietic stem cells employed (BM vs. PB) and the disease phase     (good vs. poor prognosis). In particular, on the basis of compatibility with their donor,     patients will be allocated to 2 different arms: those transplanted from an unrelated donor     either perfectly matched or with a single allelic disparity at one of the HLA loci (i.e. A,     B, C, and DrB1) vs. those transplanted from an unrelated donor either with 2 allelic     disparities or with an antigenic disparity at the HLA loci (i.e. A, B, C, and DrB1).      Patients enrolled in the study will be randomized to receive ATG (Fresenius) at a dosage of     either 30 mg/Kg (10 mg/Kg on days -4, -3 and -2) or 15 mg/Kg (5 mg/Kg on days -4, -3 and -2).      Good prognosis patients are defined as follows: ALL in 1st CR; ALL in 2nd CR belonging to S2     group; AML in 1st CR, AML in 2nd CR and relapsed more than 6 months after stopping therapy;     NHL in 2nd CR; Ph+ CML in 1st CP; refractory cytopenia.      Poor prognosis patients are defined as follows: ALL in 2nd CR belonging to the S3-S4 group;     ALL in ≥ 3rd CR; AML in 2nd CR and relapsed less than 6 months after stop therapy; secondary     AML; NHL in 3rd CR; Ph+ CML in 2nd CP, as well as in AP; RAEB, RAEB-t, JMML.   "
235754|NCT00934570|"     The purpose of this study is to assess the sustainability of a two-year intervention aimed at     improving body mass index (BMI) and metabolic and vascular health in obese youth. The study     will compare lifestyle changes with diet and exercise alone with changes in lifestyle in     combination with metformin medication. An initial intensive exercise program will also be     compared with a standard exercise program.      Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese     children and adolescents will be associated with reduced rate of weight gain, improved BMI,     body composition, physical activity, physical fitness, insulin sensitivity, blood lipid     profiles, adipocytokines and vascular function.   "
235755|NCT00934583|"     This study will examine the ability of an Internet-based program to prevent college-aged     women from developing eating disorders.   "
235756|NCT00934596|"     To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing     technique) can shorten the left heart de-airing time and prevent or minimize cerebral air     emboli during open surgery involving exposure of the left heart to the ambient air.      To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique     compared to Lund de-airing technique.   "
235757|NCT00934609|"     The study investigates the safety and effectiveness of a 12 week endurance training program     for patients with chronic heart failure   "
235758|NCT00934622|"     This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed     pre-operatively, and at subsequent visits (following the implantation of the intraocular lens     in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.   "
235759|NCT00934635|"     The primary objective of this study is to compare the effect of two different antipsychotic     compounds which are used in the treatment of schizophrenia (paliperidone ER and risperidone)     at their target sites in two specific areas of the brain in patients with schizophrenia. A     specialized X-ray known as Positron Emission Tomography (PET) Imaging is used to assess the     areas of the brain targeted by both compounds.   "
235760|NCT00934648|"     This study will evaluate the safety and efficacy of MabThera in patients with active     rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with     methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on     days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly).     After the initial study period of 24 weeks, eligible patients may receive up to 3     re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, and the     target sample size is <100 individuals.   "
235761|NCT00934661|"     At Wake Forest University, the investigators have been using Extended Release Epidural     Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having     gynecologic surgeries and hip arthroplasties.      Hypothesis:      In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in     conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in     increasing proportion of patients who meet discharge criteria within 24 hours.   "
235762|NCT00934674|"     This study is comparing 2 formulations of bosutinib in healthy subjects.   "
235815|NCT00935376|"     The pilot project will investigate three short-term intervention programs for sleep     management in cancer survivors in a randomized controlled clinical study. Three programs to     be examined in the study are:        1. the mind-body bridging program (MBBP),        2. mindfulness meditation program (MMP), and        3. sleep education program (SEP).   "
235816|NCT00935389|"     The purpose of this study is to analyze the clinical effects and adverse reactions of     tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria.   "
235763|NCT00934687|"     Depression is frequently accompanied by a specific sad facial expression. This expression is     in part mediated by the same muscle activity that produces frown lines. Based on the     assumption that there is a positive feedback between depressed mood and the correspondent     facial muscle activity (facial feedback) the investigators will conduct a randomized     controlled pilot study in which the investigators will apply a classical cosmetic treatment     of frown lines with injections of botulinum toxin to depressed patients who did not     sufficiently respond to antidepressant medication. The investigators hypothesize that this     treatment will contribute to the amelioration of depressive symptoms in these patients. This     hypothesis is supported by a previous open case series in which remission of depression was     reported after such treatment (Finzi and Wasserman, 2006).   "
235764|NCT00934700|"     This is a randomised controlled trial in newborn infants with perinatal asphyxial     encephalopathy assessing whether a combination of hypothermia and inhaled xenon preserve     cerebral metabolism and structure.   "
235765|NCT00934713|"     The study is designed to evaluate the efficacy of montelukast on symptom-free days in     unselected group of very young children with wheeze and recurrent asthma like symptoms. The     secondary aim was to evaluate the effect of montelukast on lung function, airway     responsiveness, airway inflammation and use of rescue medication.   "
235834|NCT00941304|"     The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl)     buccal film in the treatment of dental pain.   "
235766|NCT00934726|"     Since subjective well-being and quality of life (QoL) are increasingly being recognized as     important treatment outcomes in patients with schizophrenia (Hofer et al., 2004; Becker et     al., 2005), the aim of this study is to investigate the effect of treatment with quetiapine     XR on these parameters in the acute hospital and the subsequent ambulant care setting. The     study is planned to be conducted in 15 centers all over Austria and, overall, about 150     inpatients with a ICD-10 diagnosis of acute schizophrenia are planning to be enrolled. The     duration of the whole trial will be approximately 4 months, whereas 2 visits during     hospitalization and two further visits after discharge will be scheduled. At each visit,     adverse events and safety parameters, patient satisfaction and effectiveness of the current     treatment, as well as concomitant medication and dosing schedules will be assessed and     documented.In addition to that, the patients' overall satisfaction with antipsychotic therapy     and their current quality of life will be determined using a QoL questionnaire, focussing on     the subjective experience with quetiapine XR.   "
235767|NCT00934739|"     Objectives:        1. To study the effect of anti-angiogenesis therapy on reducing the recurrence of high-risk          oral cavity cancer patients after curative local treatment.        2. To study the toxicity and compliance of post-operative anti-angiogenesis therapy      Study design:      This is a multi-center randomized controlled phase II/III two-stage study.      Study endpoints:      The primary endpoint is the tumor-free survival (primary and second primary malignancies) and     the primary analysis is to compare the tumor-free survival between groups.   "
235768|NCT00934752|"     The study will enroll patients with angiographically significant coronary de novo lesions.     Subjects will be randomized 1:1 and treated with a Lutonix catheter either before or after     bare-metal stenting (BMS). The purpose is to assess the feasibility, safety and efficacy of     the Lutonix Catheter for treatment of de novo coronary artery stenosis using two distinct     treatment strategies.   "
235769|NCT00934765|"     Obesity has been found to be a risk factor for female infertility. Studies have indicated     that obese men often have poor semen quality and require increased time to make partner     pregnant. To date, no studies have investigated the effect of weight reduction on male     fertility. The purpose of this study is to investigate the effect of weight reduction in     overweight and obese men on their reproductive function.   "
235770|NCT00934778|"     We want to compare 2 new systems for obtaining very detailed images of the smallest airways,     in the hope that they can be used to provide useful information about lung diseases without     the need for invasive tests.      Two new systems have been developed for use down the bronchoscope, which provide video     imaging of the smallest airways, each system looking at a different aspect of the structure     of the airway walls. In principal, this method could provide useful information which may     reduce the need for a surgical lung biopsy. We will therefore be assessing the value of the     additional information obtained with these two new systems.      The purpose of this research project is to gather information using both systems to gain a     greater understanding of the tissue characteristics of various diseases without the need for     a biopsy.   "
235771|NCT00934791|"     The purpose of this study is to see if one kind of immunosuppressive drug has better effects     for the patient's polycystic liver disease than another type. Tacrolimus and Sirolimus are     the two immunosuppressive drugs that will be compared for this study. Both drugs have been     commonly prescribed to prevent rejection.   "
235772|NCT00934804|"     The purpose of this study is to determine the accuracy of the Galilei corneal analyzer to     calculate the effective corneal power (keratometry, corneal curvature) in patients who have     undergone both corneal refractive surgery and lens extraction with intraocular lens     implantation.   "
235773|NCT00934817|"     The pharmacokinetics of glimepiride and metformin HCl will be compared after single dose     intake of both combinations in order to answer the following questions:        -  Is Amaryl-M 1/500 mg (Test tablet) proportional to Amaryl-M 2/500 mg tablet with regard          to the glimepiride component?        -  Is Amaryl-M 1/500 mg (Test tablet) tolerable comparing with Amaryl-M 2/500 mg?   "
235774|NCT00934830|"     Question: Is the effect of therapeutic ultrasound equally effective to antibiotic for     treatment of sinusitis? Design: A randomized clinical trial with concealed allocation,     self-assessment by the subjects and intention-to-treat analysis.   "
235775|NCT00934843|"     Randomized controlled trial of the use of glucocorticoids to improve the clinical course of     neonates post-cardiopulmonary bypass (CPB).   "
235776|NCT00934856|"     This is an open-label, multi-center, non-randomized study of the safety and tolerability of     the combination of T-DM1 plus docetaxel for the treatment of participants with metastatic     breast cancer (MBC) and of T-DM1 plus docetaxel with or without pertuzumab, for the treatment     of participants with locally advanced breast cancer (LABC). The study comprises an initial     dose finding (feasibility) part to determine the maximum tolerated dose (MTD) of T-DM1 and     docetaxel, followed by an extension part aiming to consolidate the safety and efficacy of the     recommended docetaxel/T-DM1 combination regimen.   "
235777|NCT00934869|"     Rotational deformity or malunion causes the most significant functional deficit in these     common fractures. The evaluation of the rotation may be performed with the     metacarpophalangeal joints flexed although postoperative swelling may not enable this     examination with flexion of the fingers. Furthermore, it has been shown that swelling may     cause rotation of the digit itself. The investigators propose that the swelling may cause a     mistake in the estimation of rotation, during surgery and early follow up period. This is of     special importance when open reduction and rigid fixation is performed.      Methods:      Prospective analysis of XX isolated metacarpal fractures treated, in YY patients was     performed. End-on view of the finger-nail was taken with a digital camera on the day of OR,     at 2 weeks and at 1 year. The photos were taken on a standard apparatus and from a distance     of XX cm and evaluated using ZZ software in comparison with photos taken of the other hand,     according to the involved digit. Range of motion, type of fracture and type of fixation were     compared.   "
235835|NCT00941317|"     Based on manufacturer testing, no major difference in drilling condition is expected in this     study compared to the drilling conditions previously established. However clinical testing is     needed to establish optimal drilling conditions to be used for further development in both     unaffected and affected parts of the nail. The aim of this study is to determine the optimal     drilling condition that could be used in future studies of this device in combination with     topical treatment for onychomycosis.   "
235779|NCT00934895|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.     Giving paclitaxel albumin-stabilized nanoparticle formulation together with everolimus may     kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when     given together with paclitaxel albumin-stabilized nanoparticle formulation and to see how     well it works in treating women with locally advanced or metastatic breast cancer.   "
235780|NCT00934908|"     The purpose of this study is to determine if taking green tea capsules can help prevent     weight gain in patients that start therapy with Zyprexa® (olanzapine).   "
235781|NCT00934921|"     The objective of this study was to compare the relative bioavailability of the test     formulation of Ondansetron HCl with the already marketed reference formulation Zofran® ODT     under non-fasting conditions in healthy, non-smoking, adult subjects.   "
235782|NCT00934934|"     The purpose of the study is to determine whether the effect of treating Candida spp. isolated     in the respiratory tract secretions of patients with a clinical suspicion of ventilator     associated pneumonia (VAP) on clinical outcomes will be feasible and supported by biomarker     data obtained.   "
235783|NCT00934947|"     The purpose of this study is to investigate the ability of propranolol to decrease pain and     improve recovery in burn patients with a common genotype.   "
235784|NCT00934960|"     The purpose of this study is to evaluate vision at different distances (far (13 ft),     intermediate (2.0 ft) and near (13 to 15 in)) with and without the patient's glasses (if the     patient wears them), range of vision (the difference between the farthest distance and the     closest distance that the patient can comfortably read 20/25 of the near card), and patient     satisfaction (how satisfied/happy is the patient with their vision) following bilateral     implantation of different multifocal IOLs after routine phacoemulsification.      The patients are being asked to participate in this study because you have had cataract     surgery and have received one of the IOLs implanted: ReSTOR +4.0 D, ReSTOR +3.0 D,     Crystalens, and/or ReZoom. The investigator in charge of this study is Dr. Helga Sandoval.     This study is being conducted at Storm Eye Institute at the Medical University of South     Carolina and will involve approximately 50 volunteers.   "
235785|NCT00934973|"     Background:      Irritable bowel syndrome (IBS) affects 10-22% of the United Kingdom (UK) population, with     National Health Service (NHS) costs over £200 million a year. Abdominal pain, bloating and     altered bowel habit affect quality of life, social functioning and time off work. Current     general practitioner (GP) treatment relies on a positive diagnosis, reassurance, lifestyle     advice and drug therapies, but many suffer ongoing symptoms.      A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither     GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are     widely used: NHS costs 2005 of nearly £10 million for mebeverine and over £8 million for     fiber-based bulking agents.      Cognitive behavioral therapy (CBT) and self-management can be helpful, but poor availability     in the NHS restricts its use. Development of web-based CBT could increase access without     increased costs.      Aims:        1. To pilot an randomized, controlled trial (RCT) to assess the effectiveness of the          commonly prescribed medications in UK general practice for IBS: mebeverine          (anti-spasmodic) and methylcellulose (bulking-agent) and of the patient CBT based          self-management website.        2. To assess the level of support needed for patients using the patient CBT based          self-management website for IBS (i.e., initial 30 minute telephone support session with          a nurse and email support or not).      Plan of Investigation:      135 patients aged 16-60 years with IBS symptoms fulfilling the Rome III criteria, recruited     via GP practices, will be randomised to: mebeverine, methylcellulose or placebo for 6 weeks     and to the CBT based website with a nurse telephone session and email support, website with     minimal support, or no website, thus creating 9 groups.      Outcomes: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6     and 12 weeks. An intention to treat analysis will be undertaken by analysis of covariance     (ANCOVA) for a factorial trial.      Potential Impact:      Development of a web-based self-management CBT program for IBS developed in partnership with     patients has the potential to benefit large numbers of patients with low cost to the NHS. CBT     has been shown to be of benefit for IBS but it's availability is limited due to the high cost     and therapist time required for face-to-face CBT. A website can be accessed at a time and     place convenient to the patient and the CBT program undertaken at a pace determined by     patient needs. The website could be used as a long term support for self-management.      Determining the effectiveness of commonly used drug treatments will help patients and doctors     in making informed treatment decisions regarding the drug management of IBS symptoms,     enabling better targeting of treatment to those who may benefit.   "
235786|NCT00934986|"     Purpose:      The involvement of Natural Killer cells (NK) in the efficiency of the treatment in lymphoma     and the beginning of new therapies based on function and activation of NK, justify an     improvement of knowledge about the status of the population of NK (number, function, genic     expression) in Chronic Lymphocytic Leukemia (CLL).   "
235832|NCT00935597|"     The purpose of this study is to assess preliminary efficacy and to determine the safety and     feasibility of ex vivo generated dendritic cell (HDC) infusion with and without donor     lymphocyte infusion (DLI) after allogeneic stem cell transplant (SCT). We also wish to     establish the feasibility of apheresis shipment as well as vaccine shipment and stability in     the population.   "
235787|NCT00934999|"     I. Specific Aims      Pelvic organ prolapse is a common and distressing condition that is frequently associated     with stress urinary incontinence (SUI) and often requires surgical repair. Abdominal sacral     colpopexy is the preferred operation for repairing pelvic prolapse. As many as 91% of women     with pelvic organ prolapse undergoing sacral colpopexy also experience SUI. In addition, up     to 44% of previously continent women develop SUI incontinence after sacral colpopexy: perhaps     because a sacral colpopexy may predispose to opening of the bladder neck if secured too     tightly. The selection of a surgical procedure to prevent and manage SUI in women undergoing     sacral colpopexy is empiric rather than evidence-based. Conceptually, a mid-urethral sling     may be more effective than a Burch procedure for preventing urinary leakage because a sling     provides outlet resistance beyond the bladder neck and therefore it may compensate for a     downward tension on the bladder neck resulting from the sacral colpopexy. Indeed, clinical     observations suggest that a mid-urethral sling is effective among women who have persistent     urinary incontinence after sacral colpopexy with a Burch procedure. Therefore, the     investigators' global hypothesis is that a mid-urethral sling is preferable to a Burch     procedure for preventing and improving stress urinary incontinence in women undergoing sacral     colpopexy for pelvic organ prolapse. The investigators' SPECIFIC AIMS are to evaluate     objective and subjective outcomes at 6, 12 and 24 months in 124 women with urinary     incontinence and advanced pelvic organ prolapse. All women will be undergoing a sacral     colpopexy and will be randomized to either a Burch procedure or a mid-urethral sling. The     primary endpoint is composite continence at 6 months while secondary endpoints will include     composite continence and subjective measures of incontinence, patient satisfaction and     morbidity associated with these procedures. The investigators' hypotheses are as follows:        1. At 6 months, urinary continence rates will be higher after a mid-urethral than after a          Burch procedure. Urine continence will be assessed by composite measure of incontinence:          no subjective complaint, no interim treatment, and negative standardized stress test          performed by a masked observer. This assessment will be repeated at 12 and 24 months          post-operatively to establish the medium term continence of the two procedures.          Subjective continence and patient satisfaction measures will be obtained at each of the          above visits using standardized questionnaires and pelvic organ support will be          quantified by Pelvic Organ Prolapse-Quantification (POP-Q) scores.        2. Early events (e.g., blood loss, operative time, intra-operative complications (vascular,          bowel and urological injuries), in-hospital complications (need for transfusion, febrile          morbidity, thrombotic events, wound infection, length of stay, duration of bladder          catheterization and ileus) and delayed postoperative complications (e.g., wound          infection, mesh erosion, bowel obstruction and obstructed voiding) will be collected to          compare the safety of each procedure.   "
235912|NCT00942435|"     The purpose of the study is to evaluate the efficacy and safety of the oral dose of YM150 for     prevention of venous thromboembolism (VTE) in patients undergoing major abdominal surgery.   "
235788|NCT00935012|"     Open-label Safety and Efficacy Evaluation of Fx-1006a in Patients with V122i Or Wild-type     Transthyretin (ttr) Amyloid Cardiomyopathy.      Patients who successfully complete Fx1B-201 will report to the clinical unit on Day 0 to sign     the informed consent form and determine eligibility for Protocol Fx1B-303. In addition, on     Day 0, patients will have their entrance criteria reviewed, and medical histories and     demographic characteristics obtained.      The physical examination (including weight and vital signs) and the relevant end of study     clinical laboratory tests (alkaline phosphatase, alanine aminotransferase, aspartate     aminotransferase, blood urea nitrogen, gamma glutamyl transferase, creatinine, total     bilirubin, international normalized ratio, troponin I, troponin T, and amino-terminal B-type     natriuretic peptide) from Protocol Fx1B-201 will be used for Protocol Fx1B-303. If more than     30 days has elapsed between the final study visit of Protocol Fx1B-201 and Day 0 of Protocol     Fx1B-303, an abbreviated physical examination (including weight and vital signs) and clinical     laboratory assessments must be performed on Day 0.      Eligible patients will begin once-daily dosing with 20 mg Fx-1006A at home on Day 1 (i.e.,     first dose) and will return to the clinical unit for study visits every 6 months.      Adverse events (AEs) and concomitant medication use will be collected at each 6-month visit     to the clinical unit. Blood draws for clinical safety laboratory tests and abbreviated     physical examinations (including weight and vital signs) will also be performed at each     6-month clinic visit. ECGs will be performed every 12 months on an annual basis. A telephone     call will be made at 3-month intervals between clinic visits to assess safety and use of     concomitant medications.      For the evaluation of efficacy, the Patient Global Assessment, NYHA classification, KCCQ,     6-minute walk test, and efficacy-related clinical laboratory tests (serum levels of troponin     T, troponin I, and NT-pro-BNP) will be determined every 6 months. In addition,     echocardiograms will be performed every 12 months on an annual basis.      An end of study visit including all safety and efficacy assessments will occur upon patient     completion of the study, premature withdrawal (for any reason), or in the event of program     discontinuation by the Sponsor.   "
235789|NCT00935025|"     This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending     dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305     extended-release capsules in healthy male Japanese and Caucasian subjects. Three (or four if     needed) dose levels will be given to Japanese subjects and one of the doses will also be     given to Caucasian subjects.   "
235790|NCT00935051|"     The primary objective of this study is to assess the sensitivity and specificity of a     MMP-1/TIMP-1 ratio equal to 0.24 at study entry to predict wound healing at 12 weeks' follow     up visit.   "
235791|NCT00935064|"     This study will assess the effect of direct renin inhibition on nerve function in persons     with diabetes using a double-blind, placebo-controlled randomized trial involving two     treatment arms (i.e., [1] 30 participants enrolled and randomized to 300 mg of Aliskiren; [2]     30 participants enrolled and randomized to placebo).   "
235792|NCT00935077|"     The purpose of the study is to determine the degree to which pharmacist-physician     collaborative management (PPCM) of hypertension can be adopted and implemented in clinics     with geographic and racial diversity and whether patients in clinics which implement PPCM     achieve greater blood pressure control than patients in clinics which do not implement PPCM.      Primary Hypothesis: BP control at 9 months will be significantly greater in patients from     clinics randomized to the two PPCM BP intervention groups compared to the control group.   "
235793|NCT00935090|"     RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) PET     imaging, may help find and diagnose cancer. It may also help doctors predict a patient's     response to treatment and help plan the best treatment.      PURPOSE: This phase I trial is studying FLT PET imaging in patients with cancer.   "
235794|NCT00935103|"     The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug abuser for reducing high-risk     behavior   "
235795|NCT00935116|"     The purpose of the study is evaluate the analgesic efficacy and safety profile of the Cox-2     specific analgesic Etoricoxib (arcoxia®) when administrated pre and postoperatively for     controlling pain in adult patients undergoing thyroid surgery. Patients will be followed up     in the immediate postoperative period, during the first postoperative (POD) day and in POD 2,     3 and 7. It is expected that with the addition of Etoricoxib, patients will experience less     pain during the overall postoperative period and also a better quality of recovery when     compared with the traditional analgesic regimen.   "
235796|NCT00935129|"     Randomized, two arms, open study in order to evaluate treatment satisfaction of using OmniPod     system compared with conventional insulin pump in adults with type 1 diabetes.      The study will include two consecutive 12 weeks treatment periods. According to     randomization, each patient will be treated consecutively with both treatment arms: 12 weeks     with OmniPod system and than 12 weeks with patient's previous insulin pump or vice versa.   "
235797|NCT00935142|"     The purpose of this study is to determine the toxicity of the hypoxia PET-tracer     [18F]-VM4-037 in cancer patients in two dose-steps:        -  Step 1 (3-6 patients): a single dose of maximum 8 mCi (296 MBq) dose of [18F]VM4-037 via          a bolus IV injection.        -  Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of [18F]VM4-037          via a bolus IV injection   "
235817|NCT00935402|"     Observational and epidemiological studies have found a link between obesity and short sleep     duration with the prevalence of both increasing in the past decades. At this time, it is     unknown whether short sleep is a cause of obesity and how short sleep would lead to obesity.     Some studies associate short sleep with increased levels of hormone that stimulate appetite.     This study will examine how food intake and energy expenditure can be modified by sleep     duration as a means of understanding a potential causal pathway.   "
235798|NCT00935155|"     No randomized trials have tested the effectiveness of acupuncture as a supplement to     rehabilitation after total knee replacement. Studies from related fields, however, have shown     reduction of symptoms as a result of acupuncture treatment in patients with knee pain caused     by severe osteoarthritis in the knee. Furthermore, studies have reported that the need of     pain medication was lower when acupuncture treatment was performed immediately after knee     surgery.      The aim of this study is to test whether acupuncture can reduce pain and improve disability     as a supplement to rehabilitation after total knee replacement.      One hundred and seventy patients will be allocated by drawing lots to either a treatment     group receiving exercise therapy and acupuncture or a group receiving exercise therapy alone.     Treatment will start 3 weeks after surgery at the latest.      Outcome of treatments will be measured at completion of treatment and at 3 months follow-up     by pain- and disability questionnaires as well as the recording of walking capacity.   "
235799|NCT00935168|"     The aim of this study is to determine whether patients in the Intensive Care Unit who receive     fluid resuscitation with either hydroxyethyl starch (a synthetic colloid solution) or saline     (a salt solution), have an increased rate of survival at 90 days.   "
235913|NCT00942448|"     The present study is proposed to evaluate the efficacy and safety of single doses of     Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute     moderate-to-severe pain after dental impaction surgery.   "
236775|NCT00947076|"     To demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.   "
235800|NCT00935181|"     Objective: The investigators studied the effects of respiratory muscle stretching in an     8-week pulmonary rehabilitation program. Methods: This was a simple-blind parallel controlled     trial, conducted an out-patient clinic. Twenty six patients with COPD (mean age 68 ± 6 y,     percent of predicted FEV1 47 ± 16) were randomized to either respiratory muscle stretching     group plus exercise training (RMS), and exercise training group (Sham), in an 8-week exercise     program that had 3 sessions per week. The investigators measured inspiratory and expiratory     muscle strength (by maximal inspiratory and expiratory pressure - PIM and PEM), exercise     capacity (by 6-minute walk distance), dyspnea and quality of life.   "
235801|NCT00935194|"     The purpose of this study is to determine whether Chinese medicinal herbs are effective and     safe for treating novel influenza A (H1N1) infection.   "
235802|NCT00935207|"     The purpose of this study is to show the impact of a pain diary on the communication of pain     by pediatric patients. Participants will be given a pain diary after consent and asked to     complete the record each time they have pain. A survey about the efficacy of the pain diary     will be taken prior to discharge by the nurse, physician, patient and parents. The hypothesis     is that the pain diary will improve the communication.   "
235803|NCT00935220|"     The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of     linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of     African American origin.   "
235804|NCT00935233|"     RATIONALE: Studying genes in samples of blood and/or tumor tissue from patients with cancer     may help doctors identify biomarkers related to cancer.      PURPOSE: This research study is looking at blood and/or tumor tissue samples from patients     with ductal carcinoma in situ and blood samples from healthy volunteers.   "
235805|NCT00935246|"     To reveal the genetic determinants of the treatment outcome of escitalopram in depressed     patients (by using candidate gene approach and whole genome scanning).   "
235806|NCT00935259|"     The purpose of this study was to provide human lipidomics standards with simvastatin     treatment that were to be used for comparison with similar preclinical studies.   "
235807|NCT00935272|"     To determine the safety and effectiveness of Restylane® when used for lip augmentation.   "
235808|NCT00935285|"     Ventilator-associated pneumonia (VAP) is very common in the intensive care unit (ICU),     affecting 9 to 40% of ICU patients and mortality rates range from 20 to 50% and may reach     more than 70% when the infection is caused by multi-resistant and invasive pathogens. The     most common pathogens that cause VAP are the Gram(-) bacteria. Findings indicate that TLRs     serves as an important signal in the generation of protective innate responses to bacterial     pathogens of the lung and that is required for effective innate immune responses against     Gram-negative bacterial pathogens. There is genetic evidence that mutations in TLRs increase     the risk of developing nosocomial infections. Understanding the TLR system should offer     invaluable opportunity for manipulating host immune responses.   "
235809|NCT00935298|"     Acute rejection (AR) is the main complication after transplantation, which is a severe risk     of chronic rejection and implant devitalization.      Tacrolimus (FK506) is an immunosuppressant used for the prevention of episodes of acute     rejection. Tacrolimus is characterized by a narrow therapeutic index and important     interindividual variations of its pharmacokinetic characteristics.      Tacrolimus is metabolized through the liver by the cytochrome P450 system, the cytochrome     P450 3A5 (CYP 3A5) isoenzyme specifically. Polymorphisms in the CYP 3A5 gene have been     associated with changes in metabolic function of the translated isoenzyme. These     polymorphisms result in metabolism acceleration of tacrolimus as compared to subjects having     the wild type gene, consequently leading to insufficiency of tacrolimus; it is theorized that     this leads to higher risk of acute rejection. Several retrospective studies suggested an     association between a genetic polymorphism of CYP3A5 and the interindividual variations of     tacrolimus blood concentration. In particular, our initial study showed that adult renal     transplant recipients with the CYP3A5*1/*3 and *1/*1 （expressors） genotype require higher,     fixed, starting dose compared with CYP3A5*3/*3 （nonexpressor）to reach the predefined target     exposure early after transplantation.      This prospective study is designed to evaluate whether genetic testing of CYP 3A5 can improve     tacrolimus initiation better than usual care. This study is a prospective, multicentric,     open, parallel , efficacy study. 300 receivers of a renal transplant in 8 centres will be     included.      The genotyping of gene CYP3A5 will be carried out in the 4-7days before renal     transplantation. After transplantation, the patients will be treated by MMF, corticosteroids     and tacrolimus at a dosage adapted to their genotype(0.15mg/kg/d for CYP3A5*1/*1 type and     CYP3A5*1/*3 type，0.08mg/kg/d for CYP3A5*3/*3 type).      The determination of tacrolimus blood concentration will be carried out on Day     3,5,7,14,18,21,28,35,49,63,77,90. The daily amounts of tacrolimus could be modified if     necessary to reach the desired blood concentrations. The total duration of the study for a     patient is 3 months after transplantation.      The objective of this study is to determine the initial dosage of tacrolimus in Chinese renal     transplantation patients by genotyping of the cytochrome P450 3A5   "
235810|NCT00935311|"     The purpose of this study was to evaluate analgesic efficacy and safety of     hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar     extraction.   "
235811|NCT00935324|"     Prospective, within-subject controlled study on multiple subject groups to evaluate the     meaning of CK18-fragments in the diagnosis, biological activity and prognosis of     graft-versus-host disease (GvHD). Groups consist of patients scheduled for allogenic stem     cell transplantation (allo-SCT) (Group A) and healthy voluntary blood donors (Group B).   "
235812|NCT00935337|"     The first part of the pilot study, as detailed in Unique Protocol ID No. 27522, is a     randomized clinical trial that compares the effects of a mind-body bridging program with a     sleep hygiene program to improve sleep quality in patients suffering from sleep disturbances.     In Part II of the study, the investigators will perform a six month follow-up on the same     subjects.   "
235819|NCT00935428|"     Horse-related activity can be risky. Horses are the leading cause of animal-related     fatalities in Oregon and Oregon's annual death rate from animals is 45% higher than the     national rate. By interviewing injured equestrians, the investigators may be able to     determine patterns of decision-making and behavior from their collective experience and     develop useful safety recommendations. The investigators will also determine the impact that     the injury has had on quality of life. The long-term goal of the investigators research is to     develop safety and prevention recommendations and a horse-related injury prevention program     to reduce the number of horse related injuries.   "
235836|NCT00941330|"     The patients are being asked to take part in this study because they have a hormone     receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their     doctor has told them that they have an option to receive chemotherapy or hormonal therapy     before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and     cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor     and allow them to preserve the breast or have less extensive surgery on their breast.   "
235914|NCT00942461|"     This study is designed to measure and compare the inflammatory response in laparoscopic and     open colon cancer surgery   "
235820|NCT00935441|"     This is a randomized trial designed to determine if adoption of the chronic care model in     conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can     improve glycemic control compared to patients receiving usual case management. We hypothesize     that nurse case management, with home telemonitoring of blood sugars and home HbA1c     measurement will result in additional improvements in glycemic control compared to isolated     nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower     compared to usual nurse case management. Secondary aims include an additional 5 mmHg     improvement in systolic blood pressure (among patients with hypertension at the time of     enrollment), improved patient satisfaction with treatment, improved medication adherence,     reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home     HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients     with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for     telephone communication. Patients will be enrolled and actively case managed for 9 months.   "
235821|NCT00935454|"     This clinical investigation of the hepatocyte matrix implant is an evaluation blinded     non-randomized and monocentric pilot study of Phase I, which is conducted as a therapeutic     investigation. Randomization is not possible due to ethical and practical reasons. Pending     approval of the ethical committee the study will also be conducted in Indonesia.      This new treatment procedure has already been successfully used on the basis of compassionate     use in Germany. The hepatocyte matrix implant is a new patented procedure consisting of     bio-matrix technology. A formaldehyde-free special matrix consisting of self-dissolving     polymers is applied as a carrier substance and is cultivated with human autologous cells     using a special technique. Clinically the bioartificial liver replacement tissue for patients     with end-stage hepatic disease has been developed as a first application. In this procedure     autologous hepatocytic tissue and pancreatic tissue is removed (liver resection and     pancreatic biopsy) from the patient in a first surgical procedure. The tissue is sent to a     specialized Cell Culture Laboratory. The laboratory is GMP certified for this procedure. The     cells are processed according to SOPs in a special perfusion procedure and prepared on     several platelets of matrices (platelets of 20 mm diameter and 4mm thickness). After     completion of the laboratory process the biotissues are implanted into the mesentery of the     small intestine during a second operation. The cells are growing controlled on the matrix,     take on the capillaries of the patient and thus connect to the blood circulation. The     implanted cells multiply by a specific factor and independently take over the metabolic     function of the original liver after two to four weeks. In the following process the carrier     matrix dissolves completely and implanted cells develop into liver cell tissue.   "
235822|NCT00935467|"     To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered     twice daily with meals to healthy subjects   "
235823|NCT00935480|"     To determine the efficacy of adding Isentress®, with or without Celsentri®, to effective     conventional antiretroviral therapy (comprising at least 2 reverse transcriptase inhibitors     and one boosted protease inhibitor), on residual HIV replication and blood cell and     gut-associated lymphoid tissue reservoirs (reverse transcriptase inhibitors: RTIs, boosted     protease inhibitors: PI/r).      To evaluate the effect of therapy intensification by means of an integrase inhibitor with or     without CCR5 inhibitor treatment on the lymphoid reservoir in patients chronically infected     with HIV-1, successfully treated with conventional triple therapy, measured by:        -  residual plasma replication between 0 and 50 copies/ml        -  intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in          gut-associated rectal lymphoid tissue (RL).        -  proviral HIV DNA levels in PBMC and RL.   "
235824|NCT00935493|"     This proposal aims to determine whether low does of the alpha-2A-adrenoceptor agonist     guanfacine can improve deficits in prefrontally-mediated cognitive functions in healthy     elderly subjects.   "
235825|NCT00935506|"     Purpose of study is to evaluate a thrombosis chamber model   "
235826|NCT00935519|"     This study will evaluate a midterm clinical and radiologic outcome patients who undergo new     alumina-zirconia composite ceramic bearing THA.   "
235827|NCT00935532|"     The objectives of this clinical trial are to compare the effects of exenatide once weekly and     insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.   "
235828|NCT00935545|"     This is an open-label, single arm study evaluating a multi-peptide (tumor-associated     antigens)/Montanide vaccine in patients < 21 years of age with recurrent or refractory CNS     tumors. The study primarily evaluates the safety of this regimen. Secondarily, immunogenicity     and anti-tumor effects will be assessed.      The primary aim is to evaluate the safety of subcutaneous injections of tumor associated     antigens (TAA) mixed with Montanide ISA-51VG in patients with recurrent or refractory brain     tumors.      The secondary aims are to evaluate cellular immune responses induced in patients after     subcutaneous injection of TAA mixed with Montanide ISA-51VG and to document tumor response in     patients with measurable disease or time to progression in patients without measurable     disease following subcutaneous injection of TAA mixed with Montanide ISA-51VG.   "
235829|NCT00935558|"     The primary aim of this study is to investigate time to progression in breast cancer patients     vaccinated with autologous dendritic cells pulsed with peptides in combination with adjuvant     aromatase inhibitor (AI), Thymosin 1 alpha and interleukin-2. The secondary aim is to     investigate whether a measurable immune response can be induced, and to evaluate the clinical     effect (objective response rate) of the vaccination regime.   "
235830|NCT00935571|"     The purpose of this study is to evaluate the incidence of postthoracotomy pain between total     intravenous anesthesia (TIVA)and inhalation anesthesia after lung surgery.   "
235831|NCT00935584|"     The VHA is a leader in electronic medical records (EMR) use for patient care. It is believed     that EMR use by doctors will improve patient-centeredness of visits, and improve clinical     care. The proposed study will determine how doctors should use the EMR during patient     consultations. We will also develop a training program to improve doctors ability to     communicate with patients while using EMR.   "
235987|NCT00943436|"     The purpose of this study is to determine whether or not energy and macronutrient intake     changes when comparing habitually active and habitually sedentary college-aged males in two     different sessions of one resting and one exercise.   "
235833|NCT00935610|"     Aging is typically associated with a decrease in skeletal muscle mass and muscle function,     which contributes decisively to disability in old age and to the loss of quality of     life.Resistance exercise can increase muscle strength, function and mass in older adults.      The primary aim of this study is to determine whether the combination of resistance training     with a supplementation of a cysteine- rich whey protein isolate (Immunocal) compared to     combination of resistance training with casein used as control (casein contains little     cysteine) could have the potential to provide a synergic beneficial impact on muscle mass and     function which could translate to an improved quality of life in elderly persons.   "
235837|NCT00941343|"     Primary Objective:        -  To assess the sexual function of Benign Prostatic Hyperplasia patients      Secondary Objective:        -  To evaluate the association between Lower Urinary Tract Symptoms severity and sexual          disorders        -  To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic          Hyperplasia patients on XATRAL 10mg OD among the different regions        -  To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the          International Index of Erectile Function (IIEF-5)        -  To assess the onset of action of XATRAL 10mg OD        -  To assess the peak urinary flow rate        -  To assess the safety and the tolerability of XATRAL 10mg OD   "
235838|NCT00941356|"     Trial Objectives:      Primary objective:        -  To evaluate the efficacy of Bio-K+CL1285® in patients with Methicillin-Resistant S.          aureus (MRSA) nasal colonization by comparing the MRSA decolonization following either          Bio-K+CL1285® or placebo treatment.      Secondary objective:        -  To evaluate the safety profile of Bio-K+CL1285®.   "
235839|NCT00941369|"     Primary Objective:      To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin     on a composite diabetes related quality of life score (DRQoL).      Secondary Objective:      A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn     basal insulin from baseline to endpoint in terms of:        -  Glycaemic parameters: 7 blood glucose profiles        -  Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia        -  Change in lipid status   "
235840|NCT00941382|"     The aim of this study is to evaluate the effect of sibutramine and metformin combination     therapy in comparison with sibutramine or metformin monotherapy over weight, adiposity,     glucose metabolism and inflammatory state in obese patients.   "
235841|NCT00941395|"     Objectives:      This study will help to establish the feasibility of a new smoking cessation and prevention     intervention including two new modules addressing alcohol use and depression. In addition, we     will demonstrate the feasibility of a smoking prevention website. Both cessation and     prevention programs will be tailored to the needs of culturally diverse urban (University of     Houston) and rural (Texas A&M) university campuses.   "
235842|NCT00941408|"     This protocol aims to create a tissue bank of breast tumors obtained at the time of diagnosis     for the identification of biomarkers for diagnosis, prognostication, and prediction of     treatment response in breast cancer. While tissue banks now exist in major hospitals in     Singapore to collect tumor specimens at the time of surgery, specimens collected at surgery     from patients who had undergone pre-operative treatment represent a post-treatment sample and     not a baseline, untreated sample. Such samples are intrinsically different from untreated     samples, and have to be analyzed separately from untreated samples. However, they remain     valuable samples, particularly if a pre-treatment sample has been obtained, providing paired     pre- and post-treatment samples, which could provide valuable information on     treatment-related tumor biomarker changes. A tissue bank comprising of samples collected     during the diagnostic core biopsy thus represents a valuable supplement to existing tissue     banks.      Approximately 10-20% of patients diagnosed with non-metastatic breast cancer will require     neoadjuvant chemotherapy. In addition, future clinical trials may include     'window-of-opportunity' studies during which biological therapy is administered for a short     period (2-3 weeks) while an operable breast cancer patient is awaiting definitive surgery.     The majority of early-stage breast cancer patients would be eligible for such trials,     allowing the rapid recruitment of breast cancer patients. When coupled with analysis of     surrogate markers of response (eg apoptosis, anti-angiogenic effects, etc), these unique     clinical trials could provide valuable insights into the biological effects of new     therapeutic agents in evaluation.   "
235843|NCT00941421|"     The purpose of this study is to determine the equivalence or not of diagnosis ability of     oesophagal videocapsul versus oeso-gastro-duodenal fiber endoscopy in the screening of     oesophagal varix.   "
235869|NCT00941863|"     The primary objective of the study was to define the safety profile and maximum tolerated     dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy     in patients with advanced, refractory solid tumors.      The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these     patients being treated with sorafenib in combination with paclitaxel and carboplatin.   "
235988|NCT00943449|"     The purpose of the study is to determine whether 4SC-201 alone or in combination with     Sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients     refractory to Sorafenib monotherapy.   "
238686|NCT00980135|"     The study shall prove whether treatment of atopic dermatitis is equally effective with     Sinecort cream as compared to standard therapy (Hydrocortisone cream).   "
235844|NCT00941434|"     Malnutrition is the leading cause of death in children in developing countries, especially     Pakistan. According to World Health Organization about 60% of all deaths, occurring among     children aged less than five years in developing countries, could be attributed to     malnutrition.      Community-based therapeutic care attempts to maximize population-level impact through     improved coverage, access, and cost-effectiveness of treatment. Such community-based     nutrition packages can provide effective care to the majority of acutely malnourished     children as outpatients, using techniques of community mobilization to engage the affected     population and maximize coverage and compliance. Children with SAM without medical     complications are treated in an outpatient therapeutic program with ready-to-use therapeutic     food and routine medications.      The Ready-to-use Therapeutic Food (RUTF) and Fortified Supplementary food has revolutionized     the treatment of moderate and severe malnutrition. The advantage of these commodities is that     they are ready-to-use paste which does not need to be mixed with water, thereby avoiding the     risk of bacterial proliferation in case of accidental contamination.   "
235845|NCT00941447|"     The purpose of this investigation is to conduct a 12-week study to compare the effects of a     self-regulation intervention (SR), in which participants will self-monitor their blood     glucose (BG) and adjust dietary intake and physical activity through the use of current     dietary and physical activity guidelines to help regulate their BG, to an education and     self-monitoring only intervention (SM), on blood glucose, self-efficacy, and diabetes     self-management activities.   "
235871|NCT00941889|"     The primary objective of this pilot study is to evaluate the effect of the HPV vaccine     Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.   "
235846|NCT00941460|"     For patients with progressive or recurrent glioblastoma there is no standard therapy. One     strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done     by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity.     In study arm A patients receive temozolomide for one week, followed by a week without     temozolomide. In study arm B patients receive temozolomide for three weeks, followed by a     week without temozolomide. The regimen that is less toxic will be selected for further     evaluations.   "
235847|NCT00941473|"     To evaluate for the effect of corticosteroid epidural injections on bone mineral density in     postmenopausal women. Candidates for the study: Post menopausal women between the ages of 55     and 80. No history of bone disease. No thyroid/parathyroid disorder. not used injected or     oral steroids in the last year. No recent smoking.      The purpose is to identify any significant change in bone mineral density with the use of     epidural steroid injections. This may implicate the need for patient counseling regarding     this possible side effect and the possible use of preventive measures to avoid this adverse     effect.   "
235848|NCT00941486|"     The objective of this study is to evaluate the efficacy of FST-100 (0.1% dexamethasone)     Ophthalmic Suspension in the treatment of suspected acute adenoviral conjunctivitis.   "
235849|NCT00941499|"     The goal of this clinical research study is to find the best combination of oxaliplatin,     bevacizumab, 5-fluorouracil, leucovorin, and cetuximab that can be given to patients with     advanced cancer that has spread to the liver. Different combinations of these drugs will be     used, and the safety of all drug combinations will also be studied.   "
235850|NCT00941512|"     This study was designed to gather digital pictures of the cervix and correlate it to its     histopathology, and then use those relationships to teach a computer how to objectively find     cervical dysplasia and cancer.   "
235851|NCT00941525|"     The purpose of this study is to determine whether 24-hour fluctuation of intraocular pressure     (IOP) is associated with central corneal thickness (CCT) in subjects with ocular hypertension     or open angle glaucoma and in age-matched controls. Also to evaluate whether mean IOP     reduction as a response to latanoprost (0.005% Xalatan) is associated with CCT, after a     4-weeks period of treatment.      Also, to evaluate whether 24-hour fluctuation of IOP is associated with corneal hysteresis     (CH) measured by Ocular Response Analyzer (ORA).   "
235852|NCT00941538|"     Compared with the early diagnosis rate and the mortality rate between the patients of     nasopharyngeal carcinoma (NPC) from the screening group and the control group, new screening     protocol is conducted into high-risk population in Guangdong Province, China. Meanwhile, we     also perform epidemiological surveys of the screening population to acquire the baseline     information. Through analyzing the risk factors, this study can provide a population-based     prospective evidences to better understand the reasons of NPC onset in high-risk population.   "
235853|NCT00941551|"     The aim of this study was to compare the prevalence of recurrent nodular goiter in the     contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral     multinodular goiter receiving versus not receiving prophylactic levothyroxine treatment     postoperatively in a five-year follow-up of a randomized study   "
235854|NCT00941564|"     The objective is to assess the comparative calcium absorption and gastrointestinal (GI)     tolerance in healthy normal term infants fed two commercially available powdered milk-based     formulas which contain different fat blends.   "
235855|NCT00941577|"     To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in     subjects with mild asthma inhaling an allergen.   "
235856|NCT00941590|"     The purpose of this study is to assess clinical outcome in patients with tick borne     encephalitis.   "
235857|NCT00941603|"     The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the     reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of     treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or     mixed hyperlipidemia. The study will also evaluate the effect of SCH 900271 on non-high     density lipoprotein cholesterol (non-HDL-C) and various other lipids and lipoproteins. The     safety of SCH 900271 in this participant population will also be evaluated.   "
235878|NCT00941980|"     This study is being conducted to determine the percentage of patients with solid spinal     fusions after being treated with Osteocel Plus in a PLIF procedure. Due to the unique     processing conditions, Osteocel Plus retains a high concentration of stem cells attached to     the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will     be comparable to published data for autograft. The Osteocel product family has already been     used in approximately 20,000 cases worldwide.   "
236130|NCT00938613|"     The primary objective of this study was to compare the relative efficacy of Budesonide     administered via Captisol-Enabled Budesonide nasal solution and Rhinocort Aqua in patients     with seasonal allergic rhinitis (SAR) exposed to controlled ragweed pollen using an EEC     model.   "
235858|NCT00941616|"     The aim of this study is to assess the pharmacokinetics (PK), efficacy, and safety of     Biostate® in subjects with Von Willebrand Disease (VWD).      Pharmacokinetic Component:      PK parameters will be determined from a subgroup of subjects. Subjects who complete the PK     component will subsequently continue in the efficacy component of the study, either     continuing on a previously established prophylaxis regimen or continuing to receive on-demand     treatment with the occurrence of non-surgical bleeding (NSB) events.      Efficacy Component:      Three treatment arms are defined for the efficacy component of the study. (1) Subjects who     are currently being treated on a set prophylaxis regimen with a VWF product at the time of     study entry will be enrolled in the Prophylaxis arm. (2) Subjects not being treated on a     set prophylaxis regimen at the time of study entry who require a VWF product for the     treatment of NSB events will be enrolled in the On-demand arm and commence using Biostate     in the treatment of NSB events. (3) Subjects enrolled in the On-demand arm have the     possibility to enter the Cross-over to Prophylaxis arm to receive an additional 12 months     of prophylactic treatment.   "
235907|NCT00942370|"     The purpose of this study is to assess the delay between the detection (by     mechanomyography-MMG) of rectus abdominis contraction and the detection of cough in cough     effort.   "
235908|NCT00942383|"     The purpose of this study is to investigate the potential for visualizing     radiofrequency-induced (RFA) and microwave-induced (MWA) hepatic thermal ablation lesions     using a novel, high resolution, and freehand ultrasound elasticity imaging method in human     subjects.   "
235859|NCT00941629|"     The purpose of this study is to evaluate the equivalence of CPT treatment delivered remotely     via telemental health (TMH) over videoconferencing or via traditional face-to face (FTF)     treatment to veterans who have Post-traumatic Stress Disorder (PTSD) from a military-related     stressor (i.e., combat, sexual assault, non-combat physical assault). The secondary objective     is to determine if patients' ratings of PTSD symptoms, affect, social adjustment, therapy     alliance, treatment satisfaction and therapist satisfaction, are equivalent between     service-delivery conditions (TMH vs. FTF). A final objective is to develop web-based practice     assignments to assist participants in the TMH condition with treatment adherence (completion     of the between- session practice assignments).   "
235860|NCT00941746|"     The purpose of this study is to evaluate the safety and tolerability of a single intravenous     dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring     substance, nerve growth factor (NGF).   "
235861|NCT00941759|"     The purpose of this study is to study patients presenting with stage IV breast cancer. Stage     IV means that the breast cancer has spread to another part of the body outside the breast.     This study is important because in different parts of the country some patients are being     offered surgical treatment for the breast tumor and some are not. The doctors do not know if     surgery for the breast tumor is helpful in patients with stage IV breast cancer. The doctors     will collect information about the patient and their treatment to learn more about how     patients and doctors make treatment decisions. The doctor will also collect blood samples and     tissue samples for laboratory studies to learn more about tumors that have spread to other     parts of the body.   "
235862|NCT00941772|"     The purpose of the study is to determine if ultrasonography is an adequate means for     confirmation of nasogastric tube placement and that ultrasonography is more time efficient     than radiography confirming nasogastric tube placement.   "
235863|NCT00941785|"     The aim of the study is to determine whether piperaquine plus dihydroartemisinin (DHA-PQ) is     as effective, and better tolerated, than sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ),     when used for seasonal Intermittent Preventive Treatment (IPT) to prevent malaria in children     aged 3 to 59 months in Bobo-Dioulasso, Burkina Faso and to determine the pharmacokinetics of     piperaquine in children.   "
235864|NCT00941798|"     Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose     combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an     inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The     objective of this safety trial was to assess the effect of treatment on the incidence of     serious asthma exacerbations, defined as asthma related hospitalization and/or intubation     and/or death. This was an event driven trial.   "
235865|NCT00941811|"     The occurance and clinical course of human papillomavirus (HPV)-induced lesions is largely     determined by the nature of the cellular immune defense generated. Even tough both genital     warts and vulvar intraepithelial neoplasia (VIN) are HPV-associated genital lesions they     differ in their risk of malignant progression. Imiquimod (IMQ) is a topically applied     Toll-like receptor (TLR) 7 agonist that has been approved for the treatment of superficial     (pre-) carcinomas of the skin (basal cell carcinomas, actinic keratosis) and HPV-associated     lesions (genital warts). It acts by activation of the immune system exerting anti-tumor and     anti-viral properties. The aim of the study is to evaluate the mechanisms of IMQ treatment     and to analyze the differences in HPV-affected and non affected tissue at cellular and     molecular level as determined by immunofluorescence stainings and real time PCR,     respectively.   "
235866|NCT00941824|"     Mycophenolate acid (MPA) has been developed and approved in combination with cyclosporine and     has been used in kidney transplantation for more than a decade. At present, combination of     tacrolimus and mycophenolate acid tends to be considered as the standard of care for     maintenance immunosuppression in kidney transplantation. Mainly due to a different effect on     the entero-hepatic recycling pathway, cyclosporine and tacrolimus differently interfere with     MPA clearance. When used with tacrolimus, MPA dosage has thus to be adjusted and cannot be     extrapolated from what is recommended for a cyclosporine-based treatment. However, there is     currently no clear guideline for MPA dosing when this drug is used in combination with     tacrolimus. This is potentially detrimental for patients since under-or overexposure of MPA     has been clinically linked to the outcome of transplantation.      The purpose of this study is to pharmacologically validate an original MPA dosing regimen in     combination with tacrolimus within the three months post-kidney transplant. This regimen     consists in an intensified dosing of mycophenolate sodium during the earliest period of     transplantation in order to rapidly reach the appropriate MPA blood exposure followed by a     gradual decrease in dose in order to prevent MPA overexposure.   "
235867|NCT00941837|"     In this study, the investigators address the research question of whether palm olein will     have a positive influence on plasma total homocysteine levels in human volunteers provided     with high-protein diets formulated from common Malaysian foods.      Hypothesis: There is a significant difference on the effects of the three experimental oils     (palm olein, olive and coconut oil) on plasma tHy levels and the other markers of coronary     heart disease (CHD) risk measured.   "
235868|NCT00941850|"     Patients are randomised to receive ongoing optimised device and medical therapy or triple     ventricular site resynchronisation. The hypothesis states that patients receiving triple-site     resynchronization will exhibit a better response.   "
235870|NCT00941876|"     HIV positive women and couples have broad reproductive health needs that are not always met     within HIV services. The integration of family planning (FP) services into Tanzania's HIV     Care and Treatment Clinics (CTC) will address the fertility desires of CTC clients and     ultimately result in the reduction of unintended pregnancies and HIV incidence. One strategy     for integrating FP and CTC services is to use a facilitated referral model. Facilitated     referrals are enhanced referrals for additional services that have been used in other     settings and which are the preferred intervention strategy the Government of Tanzania would     like to pilot test. This study will evaluate the feasibility, effectiveness, and costs of     implementing a facilitated referrals intervention by examining FP use among female clients     attending HIV/AIDS Care and Treatment Centers. This study will measure whether there is a     reduction in unmet need for contraception among female CTC clients after the facilitated     referral integration intervention has been implemented.   "
235915|NCT00942474|"     The purpose of this study is to assess the ability of the nerve access tool to facilitate     nerve stimulation lead placement.   "
235872|NCT00941902|"     Soluble secreted proteins that are expressed uniquely in specific organs and whose formation     of secretion is regulated by disease states are excellent markers for the disease. This is     because the disease can be diagnosed by simply measuring the levels of the secreted protein     in serum. A soluble form of the asialoglycoprotein receptor could be a promising candidate     for such marker in the case of liver fibrosis secondary to steatohepatitis for which the     existing markers are not satisfactory. The human asialoglycoprotein receptor (ASGPR) is     expressed only in hepatocytes. The H2a alternatively spliced variant of the ASGPR H2 subunit     differs from H2b variant only by the presence of an extra pentapeptide. EGHRG, in the     exoplasmic domain next to the membrane-spanning segment. H2a is rapidly cleaved to a36 kDa     fragment, comprising the entire ectodomain, which is secreted. H2a does not participate in a     membrane bound receptor complex with H1 as in the case for H2b and thus it is not a subunit     of the receptor but a precursor for a soluble secreted form of the protein (sH2a). Although     H2a is a type II transmembrane protein, signal peptidase is probably responsible for the     cleavage to the soluble form.      The objective in this research proposal is to study the association between the level of     sH2a. in the serum and the severity of fibrosis in steatohepatitis in patients undergoing     bariatric surgery due to morbid obesity.      The existence of sH2a in normal human serum is at very constant levels. On the other hand the     membrane ASGPR (expressed exclusively in hepatocytes) is profoundly down - regulated in liver     cancer and cirrhosis. The investigators will analyze the levels of sH2a in serum from     patients with steatohepatitis in different stages of fibrosis and compare with healthy     subjects. A possible early down-regulation of sH2a in fibrosis may prove to be a valuable     diagnostic tool.   "
235873|NCT00941915|"     The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute     and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the     prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period.     The prostate is localized and the plan is reoptimized as needed prior to each treatment.   "
235874|NCT00941928|"     The goal of this clinical research study is to learn if transferring the donor's NK cells, in     combination with an antibody called epratuzumab and low-dose interleukin (IL-2), into your     body can be done safely. Researchers want to find out if the infused NK cells will survive     after the infusion and if the NK cell infusion helps to destroy cancer cells in the     recipient's body and possibly to help control the disease.      Primary Objectives:      · Evaluate the feasibility of collecting an adequate number of natural killer (NK) cells from     a donor and evaluate the safety of a haploidentical donor-derived NK cell infusion,     Epratuzumab, and low-dose interleukin-2 (IL-2).      Secondary Objectives:        -  Quantification and persistence of the infused donor NK cell in vivo;        -  Quantification and persistence of cytokine levels;        -  Assessment of NK cell immunophenotype and function;        -  Correlate above with anti-tumor effect.   "
235875|NCT00941941|"     The study aims at establishing the effectiveness of the non-mesh (Desarda) technique for the     treatment of primary inguinal hernias at Mulago Hospital in Uganda. First developed and used     in India, the Desarda method is reported to offer superior outcomes such as minimal     postoperative groin pain and near zero recurrence rates. In comparison to the mesh-based     repairs, it is a simple and affordable technique suitable for the resource-constrained     communities. It is devoid of complications associated with foreign body implants. Early     clinical outcomes which include acute groin pain, time to resumption of normal gait,     operative time and complications will be assessed. Participants will be followed at 2 hours,     3 days, 7 days and 14 days postoperatively.      The investigators hypothesize that the mean postoperative acute groin pain score, or the mean     postoperative day of return to normal gait is different in adult patients who undergo the     non-mesh (Desarda) repair from what it is in those who undergo the mesh (Lichtenstein)     technique of hernia repair.   "
235876|NCT00941954|"     Diabetes is a debilitating chronic disease reaching epidemic proportions. Lack of physical     activity is a key factor driving this epidemic and it is therefore vital that workable     methods of encouraging people to exercise and reducing inactivity are developed and tested if     we are to stem the rising tide of diabetes.      This cluster randomised controlled trial will investigate whether a person−centred group     educational programme can increase walking activity and reduce the risk of developing     diabetes in high−risk individuals identified in primary care settings. In total 804 patients     will be recruited to the study. Physical activity levels, glucose control, incidence of type     2 diabetes and anthropometric measurements (e.g. weight) will be tested on an annual basis     over three years.      This trial will be the first to test the feasibility, efficacy and value for money of a     physical activity intervention aimed at reducing the risk of diabetes in a community setting     in a multi−ethnic population in the UK.      Primary research hypothesis: A pragmatic structured education programme aimed at promoting     walking activity initiates long−term increases in physical activity in individuals identified     through a risk score as having an increased risk of developing type 2 diabetes.   "
235877|NCT00941967|"     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. It is not yet known whether sorafenib tosylate is more effective when given with or     without gemcitabine hydrochloride and oxaliplatin in treating patients with liver cancer.      PURPOSE: This randomized phase II trial is studying sorafenib tosylate to see how well it     works when given with or without gemcitabine hydrochloride and oxaliplatin in treating     patients with locally advanced, unresectable, or metastatic liver cancer.   "
239276|NCT00986752|"     The purpose of the study is to evaluate the efficacy of stenting after dilation with or     without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral     artery disease.   "
235879|NCT00941993|"     This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the     effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine     solution for provision of tympanic membrane anesthesia in patients who are indicated for an     ear procedure requiring penetration of the tympanic membrane, including, but not limited to,     myringotomy, tympanocentesis with culture or tympanostomy with tube placement.   "
235880|NCT00942006|"     The investigators will compare doxycycline and ceftriaxone in treatment of patients with     suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that     the efficacy and adverse effects of both antibiotics are comparable.   "
235909|NCT00942396|"     Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography     (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast     cancer.   "
235962|NCT00943111|"     This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate     (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals     with enzyme replacement therapy (ERT).   "
235881|NCT00942019|"     The investigators want to assess differences in lung function and bronchial inflammation of     young smokers and non-smokers with (BMI > 30) and without obesity (BMI < 25)(4 patient     groups). The aim of the study is to compare differences in lung function (VC, FEV1, VC/FEV1,     metacholine challenge) and bronchial inflammation in relation with smoking history and levels     of exhaled CO. For the latter the investigators will analyze the levels of IL-8, IL-6, TNF     alpha and INF gamma and mRNA of LBP, TLR2 and TLR4 in sputum. Further, inflammatory markers     e.g. low CRP and inflammatory cytokines levels in the blood will be investigated. The aim is     to describe a early stage of chronic obstructive pulmonary disease caused by cigarette smoke     in juvenile smokers, and the relationship between bronchial inflammation and obesity in     adolescents.   "
235882|NCT00942032|"     The aim of this observational study is to collect and evaluate the current clinical     experience gained from the Hindfoot Arthrodesis Nail (HAN) for ankle and hindfoot fusions.   "
235883|NCT00942045|"     This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus     in subjects who receive ACDF surgery at one or two levels. These subjects will present with     degenerative conditions in the cervical spine that are amenable to surgical treatment and     will be screened prior to study enrollment. Subjects will receive Osteocel Plus, without any     other biologic product, during their ACDF operation. The ACDF procedure will be conducted     with a radiolucent graft containment device such that progression of fusion can be adequately     assessed via radiograph. Subjects will be followed for 24-months following surgery to     determine the number of study subjects that are solidly fused at or before 24 months     postoperatively, and to determine the mean time to fusion. This data will be compared to     published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic     Protein (BMP).   "
235884|NCT00942058|"     One third of patients with kidney cancer are diagnosed in the metastatic stage, and among     patients with a localized form, about 30 to 40% will develop metastases after surgery.      Medical treatment of metastatic renal cancer include immunotherapy with interferon α and/or     IL-2, or targeted therapies such as anti-angiogenic (anti-vascular endothelial growth factor     (VEGF), anti-tyrosine kinase inhibitors and m-TOR). These treatments sometimes associated (or     IL2 + INF or INF AntiVEGF) do allow for objective response in 15 to 30% of cases (net benefit     of targeted therapies), but are carriers of potentially significant side effects and are very     expensive. The treatment response is considered on imaging exams repetitive, costly and     inconsistently reliable. A serum marker of tumor development would be particularly welcome.      CA9 is an oncogene also know as CA IX, carbonic anhydrase 9 or MN/CA9. The gene encoding an     oncoprotein called indifferently membrane antigen MN, MN/CA9 isoenzyme, carbonic anhydrase IX     CA9, G250/MN/CA9 or protein G250. It was demonstrated that the level of expression of CA9 in     tumor tissue can be used as a predictive marker of response to immunotherapy.      In previous studies, the investigators tried to use CA9 to improve the differential diagnosis     of kidney tumors using tumor biopsy or fine needle aspiration. More recently, the     investigators have developed the ELISA and quantitative reat time polymerase chain reaction     (RT-PCR) to study the CA9 protein and CA9 mRNA in the serum of patients with non-metastatic     kidney cancer. The investigators have thus shown that CA9 was overexpressed prior to surgery     and that this expression disappeared after tumor ablation.   "
235885|NCT00942071|"     This is an open label phase I study, to assess the safety of a novel influenza vaccine,     MVA-NP+M1. All volunteers recruited will be healthy. Twelve volunteers will be administered     with a single dose of 5 x 10^7 pfu of MVA-NP+M1 via the Intradermal (ID) route (group 1).     Sixteen volunteers will receive Intramuscular (IM) MVA-NP+M1. The first 8 volunteers will be     administered a single dose of 5 x 10^7 pfu of MVA-NP+M1 followed by a further eight receiving     2.5 x 10^8 pfu of MVA-NP+M1 (group 2). The 3rd group will be split into 3 groups of 10     volunteers in the age ranges 50-59, 60-69 and 70 and above and administered intramuscularly     with a single dose of 1.5 x 10^8 pfu of MVA-NP+M1. Safety data will be collected. The     secondary aim of this study will be to assess the cellular immune responses generated by each     dose.   "
235886|NCT00942084|"     Acyclovir is a drug used to treat herpes simplex virus (HSV) infections in babies.     Appropriate dosing of acyclovir is known for adults and children but acyclovir has not been     adequately studied in full-term or premature neonates. HSV is a very serious infection in     babies <6 months of age and often results in death or profound mental retardation. HSV leads     to profound mental retardation in young infants because the virus attacks the central nervous     system.      The investigators hypothesize that the currently recommended dose of acyclovir is inadequate     to produce adequate blood levels to combat herpes simplex infection. The investigators     propose to study acyclovir levels in the blood of babies who are placed on acyclovir to treat     a suspected HSV infection. This will allow them to determine the appropriate dose in     premature infants. This is an unmet public health need because it is likely that the drug     behaves differently in premature infants than it does in term infants and older children.     Premature babies have more body water and less body tissue. Their kidneys are more immature     and do not function as well as full term infants. Premature neonates are also at the greatest     risk from herpes infection because they have poorly functioning immature immune systems.     Early and appropriate treatment with acyclovir has resulted in improved outcome in term     infants.   "
235887|NCT00942097|"     The purpose of this study is to evaluate the efficacy of homeopathic treatment in pregnant     women with overweight and class I obesity with suspicion of a mental disorder.   "
235888|NCT00942110|"     The purpose of this study is to examine postprandial glucose and lipid metabolism in patients     with obstructive sleep apnea.   "
239689|NCT00985777|"     The purpose of this study is to determine the safest dose of the study drug Vitamin E     Delta-tocotrienol, how often it should be taken, and how well people with pancreatic tumors     tolerate Vitamin E Delta-tocotrienol.   "
235910|NCT00942409|"     This is a Phase II, open label, fixed dose, repeat injection, single institution study.     Eligible subjects will receive up to six doses of Ad-ISF35 injected directly into a selected     lymph node under ultrasound guidance. The primary goal is to determine and monitor clinical     and biological responses in patients treated with repeat intranodal injections of Ad-ISF35.   "
236451|NCT00953147|"     This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group,     efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male     and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).   "
235889|NCT00942123|"     Metformin is the first line drug of choice for the treatment of type II diabetes. Lactic     acidosis can develop as a side effect, especially when renal failure leads to drug     accumulation. Lactic acidosis is usually attributed to an abnormal inhibition of hepatic     lactate clearance.      Growing evidence suggest that metformin can dose-dependently inhibit hepatocyte mitochondrial     function. Whether a similar effect occurs in extra-hepatic human tissues remains unknown.      The investigators hypothesize that mitochondrial dysfunction occurs during metformin     intoxication even in tissues other than the liver, thus contributing to the development of     lactic acidosis. The aim of this study is to investigate mitochondrial integrity in     circulating platelets of patients with lactic acidosis due to metformin intoxication.   "
235890|NCT00942136|"     GSK1349572 is an integrase inhibitor that is currently being evaluated for the treatment of     HIV infection. The primary objective of this study is to determine whether the addition of a     proton pump inhibitor, omeprazole, to GSK1349572 impacts the blood levels of GSK1349572. It     will also evaluate if a high fat meal impacts the blood levels of GSK1349572. In addition,     the safety, tolerability, and pharmacokinetics of single supratherapeutic (high) dose of     GSK1349572 will be evaluated.   "
235891|NCT00942149|"     This is a safety and pharmacokinetic study of single-dose daptomycin in infants > 48 hours     and < 120 days of age with suspected systemic infections. The investigators will enroll a     total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be     performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6     mg/kg of daptomycin will yield an AUC <740 mch*hr/mL.   "
235892|NCT00942162|"     The objective of this study is to evaluate the clinical activity of the GSK2132231A     immunotherapeutic in patients with MAGE-A3 positive unresectable metastatic melanoma     presenting with the predictive gene signature.   "
235893|NCT00942175|"     The purpose of this study is to assess the potential effect and safety of multiple oral doses     of dexlansoprazole, lansoprazole, omeprazole or esomeprazole, once daily (QD), on the     steady-state pharmacokinetics and pharmacodynamics of clopidogrel, and to assess the safety     of multiple doses of clopidogrel in healthy participants.   "
235894|NCT00942188|"     Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2     diabetes.   "
235895|NCT00942201|"     Hypothesis: A 2-day course of oral dexamethasone is the superior option for the resolution of     symptoms and prevention of relapse in the emergency department (ED) management of     mild-moderate asthma exacerbations.   "
235896|NCT00942214|"     Information from blood samples may help us for choosing the best treatment in future     personalized medicine. Natalizumab (NTZ) a current treatment for MS can be used as a second     line therapy if a suboptimal response to disease modifying drugs. When to introduce NTZ is     not consensual. The investigators hypothesized that biological information could rationalize     choice and thus designed a prospective open label trial to test biological markers before     treatment.   "
235897|NCT00942227|"     The purpose of this study is to determine the effectiveness of adding mechanical traction to     standard physical therapy treatments for patients with low back pain.   "
235898|NCT00942240|"     The purpose of this study is to evaluate the safety and tolerability of repeated doses of a     new investigational drug (ACU-4429) in healthy human subjects.   "
235899|NCT00942253|"     Uremic etiology Restless legs syndrome (RLS) has been associated with poorer quality of life     (QoL) compared to RLS-free counterparts mainly due to sleep deprivation factors. Exercise     training in hemodialysis (HD) patients with RLS has been proven to be a safe approach in     temporally ameliorating RLS symptoms similarly to the use of pharmacological treatment with     dopamine agonists. However it not known whether the exercise anabolic stimulus and the     dopamine agonist treatment could act synergistically for the improvement of physical     functioning and muscle performance as well as in the amelioration of augmentation symptoms in     hemodialysis patients with RLS.   "
235900|NCT00942266|"     RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin     calcium, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. It is not yet known which dose of vorinostat is more     effective when given together with combination chemotherapy in treating patients with     metastatic colorectal cancer. PURPOSE: This randomized phase II trial is studying the best     dose of vorinostat to see how well it works when given together with fluorouracil and     leucovorin calcium in treating patients with metastatic colorectal cancer that has not     responded to previous treatment.   "
235901|NCT00942292|"     The purpose of this study is to determine whether fish oils - a known source of omega-3 given     intravenously (via a 'drip') will help cure secondary deposits in the liver from bowel     cancer.   "
235902|NCT00942305|"     This is a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study of     CMX001 administered once weekly for up to 11 weeks. Dosing will be initiated immediately     following engraftment (between Days 14-30 post-transplant) to prevent/control CMV infection     or prevent disease in R+ allogeneic stem cell transplant recipients.   "
235903|NCT00942318|"     A lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control     despite intensive basal-bolus insulin regimen. In such cases, continuous subcutaneous insulin     infusion (CSII), using an external pump, could be a solution to improve diabetes control.      The aim of this study is to compare, over a one-year period, the efficacy of CSII (with     aspart insulin) and basal-bolus multiple daily injections (MDI) treatment (with detemir x 2/d     and aspart before meals) in type 2 diabetic patients, already treated by basal-bolus regimen     for at least 6 months, who didn't reach adequate target for glycemic at baseline (HbA1c>7     -10%).   "
235906|NCT00942357|"     This randomized phase III trial studies carboplatin and paclitaxel to see how well they work     with or without cisplatin and radiation therapy in treating patients with stage I-IVA     endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy     uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after     surgery may kill any tumor cells that remain after surgery. It is not yet known whether     carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy     in treating patients with endometrial cancer.   "
235916|NCT00942487|"     Summary:        -  Study title: Effects of Nebivolol on subclinical left ventricular dysfunction. A          comparative study against Metoprolol. (ENESYS study)        -  Study phase: 3        -  Study design (parallel, cross-over, etc.), randomisation and blinding procedures, type          of control (placebo or active): randomised, parallel, active-controlled, open label        -  Study treatment(s)/drug(s): Nebivolol versus Metoprolol        -  Patients:             -  characteristics: patients with hypertension and left ventricular hypertrophy             -  planned total number: 50        -  Study duration:             -  total enrolment period (months): 18             -  treatment period (months): 6             -  follow up period (months): 6        -  Total study duration (months): 24             -  Number of Centres: 1             -  Country(ies): Romania (RO)   "
235917|NCT00942500|"     The purpose of this study is to investigate the effects of postconditioning on myocardial     reperfusion in patients with ST-segment elevation myocardial infarction.   "
235918|NCT00942513|"     Does the consumption of various combinations of mono and disaccharides (lactose, sucrose and     fructose) and protein isolates (whey or soy) result in altered substrate absorption,     substrate oxidation, and glucose regulation? This proposed research will provide data to     determine the relative contribution of source of protein (whey vs soy) and carbohydrate     (mono- and disaccharides) on the observed effects of dairy products on absorption, substrate     oxidation and glucoregulation mechanisms that affect body composition.   "
235919|NCT00942526|"     Anastomotic leakage is still to be a major cause of considerable morbidity and mortality     after esophagectomy and gastric pull up for esophageal carcinoma. Risk factor analyses of     anastomotic leakage, including blood supply, graft tension, and comorbidity, have been     performed, but few studies have produced strategies that have improved operative results.     This study will be performed to identify prognostic variables that might be used to develop a     strategy for optimizing outcomes after esophagogastrectomy.   "
235920|NCT00942539|"     Lumbar puncture is one of the most common painful procedures performed on neonates in the     Emergency Department (ED). The investigators will study in a randomized controlled trial, the     efficacy of intravenous administration of a single dose of Midazolam in reducing pain and     anxiety in neonates undergoing lumbar puncture in the ED, as well as the rate of adverse     sedation reactions. The investigators hypothesize that compared with placebo, single dose     Midazolam would significantly decrease pain and anxiety and will have low rate of adverse     reactions.   "
235935|NCT00942747|"     This is an open-label trial investigating the efficacy of temsirolimus in recurrent or     refractory primary CNS lymphoma (PCNSL) after initial chemotherapy with a high-dose     methotrexate containing regimen. 37 patients are planned to be treated with weekly infusions     of 25mg Temsirolimus (first 3 patients) or 75mg Temsirolimus (all other patients) up to a     maximum of 12 months. The trial is designed in two stages, if less than one of the first 12     patients responds to treatment, the trial is stopped. In addition to efficacy, safety and     penetration of temsirolimus into the cerebrospinal fluid will be investigated.   "
235936|NCT00942760|"     Brain imaging tests are routinely used to detect the presence of a brain tumor or to evaluate     the response to treatment. Sometimes the images obtained are not specific and the only way to     establish a diagnosis is by obtaining a tissue sample. The hypotheses of the study is to     determine if multimodal MR technique will provide tissue signatures that differentiate     between tumor progression and treatment related necrosis in high grade glioma patients.   "
235937|NCT00942773|"     The purpose of this study is to:        -  Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.   "
235921|NCT00942565|"     Patient experience moderate to severe pain after abdominal surgery. This post-operative pain     can also contribute to complications such as respiratory impairment, cardiovascular events,     ileus, sleep deprivation and mood disturbance. Opioid based patient-controlled analgesia     (PCA) is commonly employed but opioids have the side effects such as respiratory depression,     nausea and vomiting, sedation, pruritus and urinary retention. Bowel motility can also be     affected. Consequently alternative or adjunct analgesic medications without these     side-effects have been investigated in order to reduce opioid consumption.      Multimodal analgesia is a technique whereby a combination of analgesic drugs with different     modes of action can be used to improve analgesia and decrease adverse effects by virtue of     synergism. Postoperatively, with adjunctive analgesia, PCA morphine consumption as well as     the side effects may be reduced. Non-steroidal anti-inflammatory drugs (NSAIDs) have been     shown to be opioid sparing and decrease the adverse effects of PCA morphine. A recent review     showed that acetaminophen combined with PCA could induce a significant opioid-sparing effect     but the incidence of PCA morphine related side effects were not reduced.      It is common nowadays to give oral analgesic supplements to post-operative patients on PCA     morphine. Tramadol, an analogue of codeine, is one of the choices. However, some of the     patients cannot tolerate the side effects such as nausea, drowsiness, sweating, postural     hypotension and dry mouth. Combination of tramadol 37.5 mg and acetaminophen 375 mg, which     has been used successfully to treat post-operative pain, may improve analgesic response with     better tolerability.      This study is to assess tramadol 37.5 mg and acetaminophen 375 mg combination on the efficacy     of pain control, down stepping of morphine consumption and related adverse events with PCA     use after open colorectal surgeries.      Objectives:      This study aims to compare and evaluate:        -  The efficacy of tramadol/acetaminophen combination on postoperative pain relief after          lower abdominal surgeries        -  The effects of tramadol/acetaminophen combination on the consumption and the duration of          PCA morphine use        -  The adverse effects related to this regimen        -  The effects on postoperative bowel function, tolerability of fluid and diet, ambulatory          function, sleep, and duration of hospital stay        -  The overall satisfaction of the patients   "
235922|NCT00942578|"     Background:        -  Prednisone and docetaxel have been used successfully in treating patients with prostate          cancer, either when used alone or in combination with other agents. Researchers believe          that these anticancer effects can be increased by giving them in this specific          combination.        -  A previous study at the National Cancer Institute combined docetaxel and prednisone with          bevacizumab and thalidomide. The results of this study were promising; however, most          patients in the study required a dose reduction of thalidomide because of its side          effects.        -  Lenalidomide, a drug similar to thalidomide, may have less severe side effects. Based on          previous studies, lenalidomide is well tolerated in patients with solid tumors when used          alone or in combination with docetaxel, and it may be a good substitute for thalidomide.      Objectives:        -  To determine if lenalidomide is an appropriate and effective substitute for thalidomide          in treating prostate cancer.        -  To evaluate the safety and effectiveness of bevacizumab, lenalidomide, docetaxel, and          prednisone as a prostate cancer treatment, and to study any side effects.      Eligibility:      - Men 18 years of age and older who have been diagnosed with metastatic prostate cancer that     has not responded to standard treatment, including surgical removal of the testicles or     treatment with androgen (sex-hormone) suppressing drugs.      Design:        -  Participants will have a complete medical history and physical examination before          beginning the study.        -  Patients will be treated with 21-day cycles with a combination of four drugs:        -  (1) Docetaxel, which will be given into a vein for 60 minutes on the first day of each          21-day cycle. Patients will take dexamethasone (a steroid agent) before and after taking          docetaxel.        -  (2) Prednisone, which will be taken by mouth daily.        -  (3) Bevacizumab, which will be given through a vein over 30 to 90 minutes on the first          day of each 21-day cycle following the infusion of docetaxel.        -  (4) Lenalidomide, which will be taken by mouth during the first 2 weeks of each 21-day          cycle. The dose of lenalidomide may be adjusted if side effects develop.        -  Patients will also receive enoxaparin, a subcutaneous injection administered daily, to          prevent blood clots and/or pegfilgrastim, a subcutaneous injection on day 2 of each          cycle, to improve white blood cell counts, as directed by researchers.   "
236452|NCT00953160|"     The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new     indication of reduction in size of localized areas of the body.   "
236776|NCT00947089|"     The purpose of this study is to determine whether oxidized regenerated cellulose (ORC) is     effective to reduce the risk of surgical site infections (SSI).   "
235923|NCT00942591|"     Title: Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with     relapsing-remitting multiple sclerosis treated with interferon-beta-1b SWiss Atorvastatin and     Interferon-Beta 1b Trial In Multiple Sclerosis      Short title: SWABIMS      Study phase: Phase IIb study      Study design: Multi-center, randomized, rater-blinded, parallel-group-study in Switzerland      Investigational product: Atorvastatin 40mg every day (oral) plus Interferon-beta      Reference product: Interferon-beta-1b 250mg given      Indication: Relapsing-remitting multiple sclerosis (RR-MS)      Study objectives: Comparison of efficacy, safety and tolerability of combination of     Atorvastatin 40mg (per os) daily and Interferon-beta-1b e.o.d in patients with     relapsing-remitting multiple sclerosis compared to monotherapy with Interferon-beta-1b e.o.d.      Primary Endpoint: Proportion of patients with new T2 lesions after 15 months of treatment.   "
235924|NCT00942604|"     The purpose of this study is to determine whether topical application of PEP005 is effective     for the treatment of actinic keratoses.   "
235925|NCT00942617|"     Aspirin has been shown to reduce cardiovascular events in at risk individuals. Elucidation of     mechanisms of aspirin resistance and a possible loss of effect of aspirin over time with     chronic aspirin treatment necessitate a more precise method of measuring the release phase     of platelet activation, including the release of dense granules from platelets.   "
235926|NCT00942630|"     In a prospective study the investigators perform repeated cholangioscopies in all patients     that received percutaneous transhepatic biliary drainage (PTBD) for a variety of malignant     and benign diseases. Endoscopic findings and their correlation with clinical features will be     recorded prospectively. The impact on clinical decision will be evaluated.   "
235927|NCT00942643|"     The investigators hypothesize that obstructive sleep apnea (OSA) may lead to increased     formation/accumulation of advanced glycation ends (AGEs), and that the increase in AGEs is     contributed in part by increased insulin resistance. The investigators further hypothesize     that AGEs contribute to vascular endothelial damage and ultimately atherosclerosis in OSA.      The objectives of this study are:        1. To explore the relationship between insulin resistance and AGEs in OSA        2. To study the relationship between AGE and vascular endothelial dysfunction in OSA        3. To study the relationship between AGE and early atherosclerosis in OSA   "
235928|NCT00942656|"     The objectives of this study are to : 1) determine if vaccenic acid (trans-11-octadecenoic, a     naturally occurring trans fatty acid isomer from ruminant animal products) raises LDL     cholesterol in a quantitatively comparable manner as mixed trans fatty acid isomers from     partially hydrogenated vegetable oils at 3% of energy intake, 2) determine if cis-9, trans-11     conjugated linoleic acid (a naturally occurring polyunsaturated fatty acid from ruminant     animal products) raises LDL cholesterol compared to a control diet, and 3) demonstrate that     mixed trans fatty acid isomers from partially hydrogenated vegetable oil raises LDL     cholesterol compared to a low trans fatty acid diet.   "
235929|NCT00942669|"     The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip     OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic     (PSG) study.   "
235930|NCT00942682|"     The purpose of this research study is to find out more about the combination of RAD001 and     sorafenib such as the safest dose to use, the side effects it may cause, and if the drug is     effective for treating neuroendocrine tumors.   "
235931|NCT00942695|"     The objective of this study is to measure the energy value of pistachios in the human diet     and study molecular mechanisms that may help explain the beneficial health effects of     pistachios.   "
235932|NCT00942708|"     This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for     three months among patients with pulmonary arterial hypertension.   "
235933|NCT00942721|"     This study will develop and test a Web-based program to treat women with postpartum     depression.   "
235939|NCT00942799|"     This is a Phase I, open-label, multicenter, dose-escalation study designed to assess the     safety and tolerability of Genz-644282, administered as an intravenous (IV) infusion, to     patients with advanced malignant solid tumors. Each 28 day cycle of treatment will consist of     3 consecutive weeks of treatment every 28 days(i.e., treatment will be administered on Days     1, 8, and 15 every 28 days). Each 21 day cycle of treatment will consist of 2 consecutive     weeks of treatment every 21 days(i.e., treatment will be administered on Days 1 and 8 every     21 days). Treatment with Genz-644282 will continue until disease progression or unacceptable     toxicity is observed. Approximately 110 patients will be enrolled in this study. Patients     will be enrolled in escalating dose cohorts until the Maximum Tolerated Doses (MTDs) for the     2 dosing schedules are established. To further evaluate safety, approximately 40 additional     patients with advanced malignant solid tumors will be enrolled and treated at the MTDs (20     for each dosing schedule) during an expansion phase.   "
235940|NCT00942812|"     Diarrhoeal diseases are still the major paediatric health concern worldwide, contributing for     2.5 million annual deaths in children. Although the treatment of diarrhoeal illness as per     the World Health Organization (WHO) guidelines brings about a considerable decline in the     burden of the disease but there is still a lot to be done for this issue. Zinc     supplementation along with Oral Rehydration Solution (ORS) has emerged as a potent approach     to treat diarrhoea. It is believed that the children having zinc deficiency are at high risk     of developing infectious diseases which eventually lead to a high burden of mortality.      In order to prevent and effectively manage diarrheal episodes, it is important that water     purification tablets, zinc and oral rehydration salt is always available in each household.     Though, these products are easily available in the market separately, but are rarely     available together in any household. If these products are made available in a single packet,     it is likely to be an effective strategy in combating diarrheal diseases in the community.   "
235963|NCT00943124|"     This study will evaluate:        1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin          (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple          combination tablet MK0524B.        2. the bioequivalence of laropiprant and ER niacin when administered as the triple          combination tablet MK0524B or as the double combination tablet MK0524A given together          with simvastatin.   "
236453|NCT00953173|"     A prospective, international, multi-center study of clinical outcomes and estimated     healthcare resource expenditures associated with the treatment of obesity using the LAP-BAND     AP® Adjustable Gastric Banding System.   "
235941|NCT00942825|"     This is a randomized, open-label, multicenter, phase II study to compare a triplet     combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered     to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial     effusion) or metastatic (stage IV) non-squamous NSCLC as consecutive i.v. infusions according     to a once-every-3-weeks schedule.      The protocol will evaluate full-dose cisplatin and pemetrexed with or without CBP501.     Patients will be randomized in a 1:1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or     pemetrexed and cisplatin (Arm B). Randomization will be stratified according to whether or     not patients are eligible for bevacizumab therapy.      Preclinical and clinical findings that support this protocol are:        -  CBP501 has exhibited interesting preclinical activity in various lung cancer cell lines.        -  Synergism was documented with CBP501/cisplatin in the preclinical studies with lung          cancer cell lines.        -  The dose-limiting toxicity (DLT) of CBP501 was rapid onset allergic reaction, as was          suggested by preclinical toxicology. Other toxicities were quite limited. No evidence of          potentiation of either CBP501 or cisplatin toxicity was found in the combination phase I          trial, and the toxicity of the combination, primarily related to cisplatin, is          manageable. It is expected that CBP501 and pemetrexed will display non-overlapping          toxicity profiles in combination, given that hematological toxicity and gastrointestinal          toxicity are the principal toxicity types of the latter.        -  Given the acceptable safety of the cisplatin/ pemetrexed combination, it is anticipated          that the addition of CBP501 to this combination can be evaluated without excessive risk          in the phase II programs.        -  The phase I study of CBP501 in combination with pemetrexed/cisplatin (phase I part of          the mesothelioma program) did not show DLTs or evidence of enhancement of toxicities          with the triplet combination. The RD of CBP501 25 mg/m², cisplatin 75 mg/m² and          pemetrexed 500 mg/m² is currently in use in the phase II study with first line          mesothelioma patients.        -  Hints of activity were observed during the phase I study with CBP501 and cisplatin.        -  No pharmacokinetics (PK) interaction was documented between cisplatin and CBP501.   "
235942|NCT00942838|"     The proposed study is a prospective cohort study incorporating patients with first recurrence     ovarian or primary peritoneal cancer who will receive intraperitoneal chemotherapy in     conjunction with whole abdomen radiation. The primary end point of this investigator     initiated research study is to determine the toxicity associated with whole abdomen radiation     in combination with intraperitoneal chemotherapy.      Primary Objective:        -  Determine the maximum tolerated dose (MTD) of whole abdomen radiation in conjunction          with intraperitoneal cisplatin chemotherapy in the treatment of women with small volume          (< 1 cm) recurrent ovarian cancer confined to the abdominal peritoneal cavity.      Secondary Objective:        -  Quality of Life assessment.   "
235943|NCT00942851|"     Background:        -  Blepharospasm is caused by excessive contraction of the muscles that close the eye. It          can be treated with injections of botulinum neurotoxin (BoNT), which works by weakening          those muscles.        -  Acetyl Hexapeptide-8 (AH-8) is the active ingredient in a number of cosmetic creams used          to treat wrinkles, and is marketed under the trade name Argireline(Copyright). Like          BoNT, AH-8 works to weaken the muscles, but is available as a skin cream instead of an          injection. AH-8 has never been used to treat people with blepharospasm.      Objectives:      - To determine if AH-8 can be used as part of a treatment regimen for blepharospasm.      Eligibility:      - Individuals 18 years of age and older who have blepharospasm and have been receiving     successful treatment with botulinum toxin injections.      Design:        -  Participants will be involved in the study for a maximum of 7 months.        -  Patients will have a complete physical and neurological exam, and will be asked          questions about their blepharospasm. Patients will then receive BoNT injections in the          same areas of the muscle around the eye and at the same doses that have been effective          previously.        -  After the injections, patients will receive a container of either the active cream (with          AH-8) or cream without AH-8, and will be instructed on how to apply it.        -  Patients will return 1 month after the first visit for another neurologic exam and          questions, and will be asked about any side effects. Another supply of cream will be          given.        -  Five additional visits will take place on a monthly basis, and patients will be given          additional supplies of the cream as needed. Patients will stop participating in the          study if they require another BoNT injection for blepharospasm. The study will end after          7 months.   "
235944|NCT00942864|"     The purpose of this study is to evaluate the effects of intravitreal Lucentis® (Ranibizumab)     and investigate the anatomical and functional improvement following this treatment in     patients with macular edema due to retinal vein occlusion (RVO).   "
235945|NCT00942877|"     Background:        -  Alveolar soft part sarcoma is a type of cancer that develops in tissues that connect,          support, or surround other organs in the body. It relies heavily on new blood vessels to          grow and spread through the body. There is no effective systemic treatment for patients          with alveolar soft part sarcoma.        -  The drug AZD2171 (cediranib) is an experimental drug, not yet approved by the Food and          Drug Administration. The drug blocks the creation of new blood vessels. The drug has had          initial clinical trials, and researchers are interested in determining whether cediranib          is effective in inhibiting tumor growth in individuals who have alveolar soft part          sarcoma.      Objectives:      - To find out whether AZD2171 works in patients who have alveolar soft part sarcoma.      Eligibility:      - Individuals 18 years of age and older who have been diagnosed with alveolar soft part     sarcoma.      Design:        -  After an initial screening visit, patients will take AZD2171 by mouth once a day, every          day for the duration of the study. The treatment will be given in 28-day cycles.        -  Patients will keep a study diary to record the doses taken, any missed doses, and any          side effects.        -  Patients will have the following tests and procedures during the treatment period:          clinic visit with physical examination every 2 weeks, regular blood pressure monitoring,          blood and urine tests, heart function tests, imagining scans to evaluate tumor size and          response to the treatment, and possible tumor biopsy.   "
235946|NCT00942890|"     The purpose of this randomized control study is to determine if administering neuromuscular     electrical stimulation (NMES) to the thigh muscles of a below the knee amputee is more     effective than the current standard of care in preserving thigh muscle strength. In addition,     this study will examine the NMES treatment effects on the participant's gait, quality of     life, functional performance of standing, walking, and stair climbing, and symptoms     associated with residual and phantom limb pain. The primary aim is to compare NMES plus     standard rehabilitation (treatment group) to the standard rehabilitation (control group) by     measuring lower extremity muscle strength. The secondary aims are to compare NMES treatment     group to the control group by measuring Quality of Life (QOL) and the symptoms associated     with residual & phantom limb pain. In addition to the specific aims, this study will also     examine the two groups for functional performance and gait patterns after prosthetic fitting.   "
235947|NCT00942903|"     This study is a short term feasibility study that aims to investigate patient satisfaction     with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are     considered are for example performance for stoma occlusion, speaking, breathing, appearance,     compliance, and short-term impact on pulmonary symptoms.   "
235948|NCT00942916|"     This study is for those who had nontuberculous mycobacterial pulmonary infection with higher     a serum inflammatory marker than those who had colonization.   "
235949|NCT00942929|"     The investigators hypothesize that lung function would be adversely affected at the     hypocaloric stage of adolescents suffering from anorexia nervosa.   "
235950|NCT00942955|"     The hypothesis of this study is that POCT will shorten ED turn-around-time (TAT) such as     blood drawing TAT, lab TAT, and decision TAT.   "
235951|NCT00942968|"     The purpose of this study is to determine the long term tolerability and safety of dalteparin     in subjects with cancer.   "
235952|NCT00942981|"     Background:        -  Some illnesses, such as schizophrenia, have effects on brain cells called dopamine          receptors, which are required for normal brain function. People with schizophrenia have          difficulty thinking and experience hallucinations and delusions. Medications that change          brain dopamine receptors can decrease these hallucinations and delusions.        -  The cause of schizophrenia and its association with brain dopamine receptors is not          known but may be clarified by studying dopamine receptors in people who have dopamine          disorders (such as schizophrenia) and those who do not. Researchers are interested in          studying the dopamine system to gain a better idea of how dopamine disorders develop,          which may lead to better medical care for people with schizophrenia.      Objectives:      - To study the amount and distribution of two types of dopamine receptors.      Eligibility:        -  Individuals between the ages of 18 and 60 who have schizophrenia.        -  Healthy volunteers between the ages of 18 and 90.      Design:        -  Participants will undergo a full screening, with physical and psychological history, a          neurological examination, and blood and urine samples.        -  Participants will have a blood flow map of the brain recorded with a positron emission          tomography (PET) brain scan. A magnetic resonance imaging (MRI) scan will also be          performed to determine brain anatomy.        -  To study the amount and distribution of dopamine receptors in the brain, participants          will receive a small amount of a radioactive chemical in the vein, followed by a PET          scan.        -  The procedure will be performed twice in two separate sessions, once for [18F]fallypride          and once for [11C]NNC-112.   "
235953|NCT00942994|"     The purpose of the study is to compare the combination of aliskiren, amlodipine and     Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in     minority Stage 2 hypertensive patients.   "
235954|NCT00943007|"     The treatment of a specific subtype of highly malignant brain tumor (called glioblastoma or     glioblastoma multiforme) consists of neurosurgical resection, followed by radiotherapy and     mostly chemotherapy as well. Increased extent of tumor resection is associated with prolonged     survival. The standard treatment uses conventional neuronavigation systems to increase extent     of tumor resection. However, the quality of this form of neuronavigation decreases throughout     surgery because of brain shift. This is caused by edema, loss of cerebrospinal fluid and     tumor resection. A new form of neuronavigation uses intraoperative MRI to compensate for     brain shift, and to check for the presence of residual tumor that can be removed.      This study aims to compare the extent of glioblastoma resection between the standard     treatment and intraoperative MRI.   "
235955|NCT00943020|"     Surgical patients are usually starved for 8 hours before operation in order to ensure the     stomach is empty and thus reduce the chances of vomiting during the anaesthetic. Recent     studies have shown that this period of starvation is harmful as it 'weakens' the body before     operation. To avoid the harmful effects of starvation, patients are now given carbohydrate     (sugar-containing) drinks 2 to 4 hours before surgery. These drinks have been shown to make     patients feel better, reduce sickness after the anaesthetic/surgery and result in a quicker     recovery from operation. The optimum time of giving these drinks to patients before operation     is unknown. Previous studies have shown that the drinks empty from the stomach within 2 - 4     hours depending on their ingredients. The investigators would like to study the effects of     adding protein and fat to these drinks on how quickly the drinks empty from the stomach. This     study will investigate the hormone responses of the body following intake of 3 different     drinks in order to determine the mechanisms that underlie the control of stomach emptying.     This information will also allow us to improve the design of these drinks and this could help     patients who undergo surgery who receive them.   "
235956|NCT00943033|"     Research aimed at assessing changes in depressogenic thinking and the ability to disengage     from depressogenic thinking following Mindfulness-Based Cognitive Therapy   "
235957|NCT00943046|"     The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker     leads.   "
235974|NCT00943267|"     Recombinant human Activated Protein C (rhAPC) has been shown to reduce the mortality of     patients with severe sepsis. The biological effects of APC are pleiotropic, and can be     roughly divided in anticoagulant and cytoprotective effects. Lung infection and inflammation     are associated with reduced bronchoalveolar levels of endogenous APC. Recent evidence derived     from animal studies indicates that local administration of rAPC into the lungs exerts local     anti-inflammatory and anticoagulant effects. In this study we propose to study the potential     of locally administered APC, within a lung subsegment, to inhibit lipopolysaccharide (LPS)     induced lung inflammation and coagulation in humans.   "
235958|NCT00943059|"     Accumulation of lipid in skeletal and cardiac muscle has been associated with insulin     resistance and diabetic cardiomyopathy. In skeletal muscle, lipotoxic damage has been     suggested to lead to dysfunction of mitochondria. It remains unknown whether lipotoxicity     leads to mitochondrial dysfunction in heart as well, and if so, whether this also leads to     cardiomyopathy (failure of the heart). Although it has been shown that lipid lowering agents     can improve insulin sensitivity, the effect of lowering free fatty acids on cardiac and     skeletal muscle mitochondrial function remains unknown. In this study the investigators want     to investigate whether lowering cardiac and muscular lipid content will improve mitochondrial     and cellular function in type 2 diabetic patients.      To this end, type 2 diabetic patients and body mass index (BMI)-matched controls will be     included in a blinded cross-over design, in which subjects will receive a lipid lowering     agent (Acipimox) or placebo for 2 weeks in random order. During treatment, diabetes     medication will be stopped. Baseline measurements will be performed prior to the study and     after each treatment to assess cardiac and muscular lipid accumulation, cardiac function,     mitochondrial function and insulin sensitivity.   "
235959|NCT00943072|"     This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on     vision function in subjects with macular edema as a consequence of central retinal vein     occlusion.   "
235960|NCT00943085|"     This study will test a family-based therapy aimed at preventing or reducing the symptoms of     bipolar disorder in at-risk children.   "
235961|NCT00943098|"     The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD     75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment     of acute moderate-to-severe pain after dental impaction surgery.   "
235964|NCT00943137|"     The purpose of this study is:        1. To determine the proportion of Asian patients achieving a target area under the curve          (AUC) of 20-24 mg.h/L using a pharmacokinetically guided 5-fluorouracil (5-FU) dose        2. To determine the safety and tolerability of dose adjusted 5-FU        3. To correlate 5-FU pharmacokinetics with gene variants associated with the 5-FU pathway          and with clinical outcomes      Based on Western data, levels of 5-FU are highly variable when doses are based on BSA. A     relationship between systemic plasma levels of 5-FU and treatment toxicity and efficacy     exists. Whilst pharmacokinetically-guided dose management has been shown to improve 5-FU     efficacy and tolerance, there is currently no data in Asian patients using this approach.     Using pharmacokinetically guided 5-FU-dose adjustment, the investigators hypothesize the     proportion of Asian patients achieving a target AUC of 20-24 mg.h/L is similar to that of     Caucasians.      METHODS:      This is an open, non-randomised single center Phase II study evaluating dose adjusted 5-FU in     patients receiving de Gramont, FOLFIRI or mFOLFOX-6 schedules.   "
235965|NCT00943150|"     The objective of this clinical study is to evaluate healing of incisions made with the PEAK     PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and     record key post-operative metrics following abdominoplasty with the PEAK PlasmaBlade 4.0     versus current standard of care (SOC); and to evaluate performance metrics of the PEAK     PlasmaBlade 4.0 during abdominoplasty.   "
235966|NCT00943163|"     Cyclorotation of eyes may be affected by motion and orientation of the head and body. An     automated alignment method with the technique of iris recognition was used to assess the     amount and orientation of position-induced cyclorotation between preoperative wavefront     measurement and laser refractive surgery.   "
235967|NCT00943176|"     The purpose of this study is to evaluate the use of modafinil in the treatment of fatigue in     patients with Primary Biliary Cirrhosis.      The general aim of the study is to identify a safe and effective therapy for fatigue in     patients with primary biliary cirrhosis.   "
235968|NCT00943189|"     Purpose: Fetal anomalies scan at the time of Nuchal Translucency (NT) study.   "
235969|NCT00943202|"     The purpose of this study is to assess the safety and immune response (body's defense against     disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study     will help determine how and when the H1N1 flu shot should be given with the seasonal flu shot     to make it most effective. The 650 participants will be divided into the following age     groups: infants from 6 months-36 months old, children 36 months-9 years old, and adolescents     10-17 years old. Each age group will have 200 children. There are 4 treatment groups in each     age level. Study procedures include: medical history, targeted physical exam based on     history, maintaining a memory aid, and blood sample collection. Participants will be involved     in the study for about 8 months.   "
235970|NCT00943215|"     The purpose of this study is to gain knowledge about how participants behave and respond on     their own after completing a 2-year intervention of calorie restriction.   "
235971|NCT00943228|"     The primary objective of this study is to determine whether 4 grams daily of mycophenolate     mofetil (MMF) results in a greater proportion of individuals adequately exposed as measured     by drug levels (area under the curve of > 40 mg*hr/L).   "
235972|NCT00943241|"     To expand the understanding of the uptake and distribution of Tc-99m sestamibi in the breast     in a normal female population undergoing myocardial perfusion imaging using Molecular Breast     Imaging (MBI).   "
235973|NCT00943254|"     This study is being done to gain knowledge on how effective different approaches of providing     a diagnosis and varying educational tools that include DVDs and multimedia or printed     instruction sheets on your readiness to increase the subject's level of exercise, lose more     weight, eat a healthier diet; and to assess the subject's awareness of their risk of heart     disease and their readiness to participate in a comprehensive lifestyle modification program.   "
239690|NCT00985790|"     The purpose of the present study is to assess the immunogenicity and safety of vaccine     GSK2321138A in children.   "
235975|NCT00943280|"     To compare participation rates in screening for Barrett's Esophagus (BE) using sedated     esophagogastroduodenoscopy (EGD), unsedated transnasal endoscopy and capsule endoscopy in a     population based cohort. An age and gender stratified random sample of 300 patients from a     previously defined (in terms of the presence or absence of symptoms of gastroesophageal     reflux using a validated questionnaire) population based cohort from Olmsted County11, 12     using the Rochester Epidemiology Project (REP), who have not undergone endoscopy, will be     randomized to undergo screening using capsule endoscopy OR transnasal endoscopy OR     conventional sedated endoscopy. The investigators will compare participation rates in the     three arms.      To identify factors associated with non-participation in population screening for BE. The     investigators will compare demographic and clinical factors in participants and     non-participants, to help predict non-participation using data from prior surveys (data has     been collected on patient demographics, bowel and reflux symptoms, employment, education,     somatization behavior, psychological profiles using the validated Gastroesophageal Reflux     questionnaire [GERQ] and the Bowel Disease Questionnaire [BDQ]) which have been completed by     all targeted subjects. This preliminary will allow us to identify barriers to screening and     develop interventions to increase participation in future larger studies.   "
235976|NCT00943293|"     This is a clinical research study designed to evaluate whether the administration of a     vaccine to patients after transplant consisting of a minor histocompatibility antigen (mHag     peptide) mixed with G-CSF (a drug intended to stimulate the immune system) can stimulate     increased graft versus leukemia (GVL) responses without causing graft-versus-host disease     (GVHD).   "
235977|NCT00943306|"     This is a long term follow on study to assess the continued long term safety and efficacy of     lomitapide in patients with homozygous familial hypercholesterolemia.   "
235978|NCT00943319|"     The purpose of this study is:        1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in          combination with fludarabine as conditioning regimen for transplantation with in-vivo          T-cell depletion.        2. To evaluate disease free and overall survival after this conditioning regimen in          patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).        3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen.        4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.   "
235979|NCT00943332|"     Current treatment protocol for pediatric femoral shaft fractures is immediate spica casting     for patients 6 years and younger and for patients over 6 years and older is percutaneous or     open placement of titanium elastic intramedullary nails. The investigators would like to     evaluate the current treatment protocol by comparing those patients 6 years and younger     treated with closed reduction and spica casting to those 6 years and younger treated with     percutaneous pinned with titanium elastic intramedullary nails or submuscular plating. The     investigators will be comparing their post-operative functional level, pain management,     impact on family and complications through chart and x-ray reviews. The goal is to improve     patient care pre and post-operatively for those who have sustained a femoral shaft fracture 6     years old and younger and increase the knowledge of those residents/physicians who care for     this patient population.   "
235980|NCT00943345|"     Introduction: The primary function of the gastrointestinal (GI) wall is digestion and     absorption of nutrients that are important for growth and development. The second important     function of the GI wall is forming an effective barrier to prevent penetration of potentially     harmful components from the inside of the gut (lumen), via the GI wall, into the body.      A compromised barrier function may play an important role in the development of a range of     inflammatory GI diseases such as coeliac disease, Inflammatory Bowel Disease (IBD), food     allergy, but also in the pathophysiology of postoperative complications. It is important and     clinically relevant to have reliable GI permeability tests, however the existing test leave     room for improvement.      Rationale/aim: Three new tests are developed to assess gastrointestinal permeability in both     normal controls with and without raised permeability, and in patients with coeliac disease.     In the current study these new permeability tests will be evaluated and compared with the     golden standard permeability test, the dual sugar test.   "
235981|NCT00943358|"     The purpose of this study is to evaluate the antibody response to one and two doses of     influenza A/H1N1v vaccine in healthy adults.   "
235982|NCT00943371|"     A single dose study to assess the safety, tolerability, pharmacokinetics and pharmacokinetics     of MK6349 in Type 2 Diabetics.   "
235983|NCT00943384|"     The chronOS Strip is a synthetic bone void filler manufactured from chronOS beta-tricalcium     phosphate (β-TCP) granules and a resorbable polymer [poly(lactide co-ε-caprolactone)]. The     chronOS Strip, combined with autogenous bone and/or bone marrow or autograft, is intended to     be used in the spine for posterolateral fusion.      The purpose of this prospective, multi-center clinical case series was to evaluate     posterolateral fusion rates in a prospective series of patients with degenerative disc     disease. The surgical procedure consisted of instrumented posterolateral fusion with     interbody support. The chronOS Strip, combined with bone marrow aspirate and local bone, was     applied to the posterolateral gutters.   "
235984|NCT00943397|"     Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who     completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study.     Additionally, patients with asthma who were 6 to 11 months of age and who had not     participated in Protocol MK0476-176-01, could also enroll.   "
235985|NCT00943410|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy     x-rays to kill tumor cells. Trastuzumab may make tumor cells more sensitive to radiation     therapy. Giving trastuzumab together with radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving trastuzumab     together with external beam radiation therapy works in treating women with stage III or stage     IV breast cancer.   "
235986|NCT00943423|"     RATIONALE: A PET scan may help doctors learn how the cancer responded to combination     chemotherapy and whether radiation therapy is also required.      PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it     works in deciding whether patients who have received combination chemotherapy for stage IA or     stage IIA Hodgkin lymphoma also need radiation therapy.   "
235989|NCT00943462|"     Positron Emission Tomography-Computed Tomography (PET-CT) with injection of     18F-fluoroethylcholine (FEC) could be a useful tool in the evaluation and follow-up of     patients who have been diagnosed with glioblastoma multiforme (GBM) and who are treated with     radiotherapy and temozolomide by allowing, for example, the distinction of necrosis from     tumour tissue. This tool could help the clinician in making therapeutic decisions for GBM     patients.   "
235990|NCT00943475|"     The surgery stress relives systemic inflammatory response by hormones and adrenergic     receptors. When the pro-inflammatory mediator is higher than anti-inflammatory response, the     physiologic status is impaired and the patient is more susceptible an infection and     cardiovascular collapse. The anesthesia can abolish or minimize the surgery stress, improved     more safety to the patient.      This study is a double blind controlled trial with 40 patients divided in two groups (EMLA     and Dorsal Penile Nerve Block - DPNB) submitted a standard inhalator anesthesia and     postectomy surgery by Plastbell®. The investigators will be observe heart rate, respiratory     rate, arterial pressure, involuntary movements during the surgery and pain in the     pos-operatory.      With this study, the investigators can define what tactic (EMLA or DPNB) associated a general     anesthesia is more effective to relive the pain when children are submitted a postectomy by     Plastbell®.   "
235991|NCT00943488|"     The purpose of this study is to assess the safety and immune response (body's defense against     disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations.     The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1     infection or vaccination. Two hundred individuals will be 18-64 years old, and the other 200     will be greater than or equal to 65 years of age. Participants will be randomly assigned to 1     of 2 possible vaccine groups: group 1 will receive 15 micrograms (mcg) of H1N1 vaccine; group     2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine injections on days 0     and 21 in the arm muscle. Study procedures include: medical history, physical exam,     maintaining a memory aid, and blood sample collection. Participants will be involved in study     related procedures for approximately 7 months.   "
236052|NCT00932243|"     The presence of bacteremia and sepsis in percent of critically ill patients and none at all,     associated with different expression and faction of Toll-Like-Receptors (TLRs.   "
235992|NCT00943501|"     This trial is conducted in Europe and the United States of America (USA). The aim of this     clinical trial is to investigate the safety, tolerability, pharmacokinetics (the     determination of the concentration of the administered medication in blood over time) and     pharmacodynamics (the determination of the effect over time and the duration of action) of     multiple doses of liraglutide in the pediatric population (children).   "
235993|NCT00943514|"     Background:        -  Bronchiectasis is a disease characterized by airways that are inflamed, abnormally          dilated, and chronically infected. Individuals with bronchiectasis have a history of          chronic and recurring respiratory infections. Depending on the underlying cause, these          infections may involve the entire respiratory tract, resulting in sinus, ear, and lung          disease.        -  Bronchiectasis continues to be a significant problem in developing countries and in          specific groups of individuals, particularly in people who have cystic fibrosis.          Although treatments are available or under development for bronchiectasis related to          cystic fibrosis, many of the disease-specific treatments may not be effective for          bronchiectasis not related to cystic fibrosis.      Objectives:      - To study the natural history of bronchiectasis to identify inherited and immune factors     that may explain why certain individuals have chronic recurring infections.      Eligibility:        -  Individuals 5 years of age and older who have an established diagnosis of bronchiectasis          or a history of chronic/recurring respiratory infections.        -  Direct family members (e.g., parents, siblings, children) of patients in the study may          also be asked to participate.      Design:        -  Potential participants will be screened with an initial clinic evaluation and full          medical history, as well as a general quality of life and respiratory symptom          questionnaire.        -  The following standard procedures may be done as part of the study: air sampling from          the nose; imaging studies, which may include an x-ray or computed tomography (CT), lung          function tests; and collection of samples of blood, urine, and sputum (phlegm or mucus).          Other tests may be performed as required by the researchers, and will be explained to          patients as needed.        -  Both patients and relatives (if asked to participate) will provide the following          samples: blood or buccal (cheek swab) cells for genetic testing, sputum, and urine.        -  To prevent infections and potential disease progression, patients may receive standard          medical care and treatment for bronchiectasis and related infections during this          protocol.        -  Patients older than 18 years of age will be invited to join the Bronchiectasis Research          Registry, a program supported by the Chronic Obstructive Pulmonary Disease (COPD)          Foundation. The purpose of the program is to identify a group of people who are          interested in receiving information about research studies focused on bronchiectasis and          possibly participating in these research studies. Participants may be offered the          opportunity to participate in selected clinic trials related to bronchiectasis or          related medical conditions.   "
235994|NCT00943527|"     This study is to examine the effects of menstrual cycle, hormone therapy, and the use of     tamoxifen on Tc-99m sestamibi uptake.   "
235995|NCT00943540|"     The licensed dose of raltegravir is 400 mg twice daily with or without food. Raltegravir is     metabolized predominantly through glucuronidation by UGT1A1. Atazanavir increases the plasma     concentrations of raltegravir 400 mg twice daily by 72% due to inhibition of UGT 1A1.      This suggests that combined use of atazanavir and a lower dose frequency of raltegravir, once     daily for example, is possible. Another reason why raltegravir most likely can be applied is     that its pharmacodynamic effect is not related to Cmin but to AUC which is expected to be     similar for an 800mg QD dose when compared to 400mg BD. Phase III clinical trials evaluating     QD dosing of raltegravir are currently ongoing and interim results are expected to be     published in mid 2009.      A regimen of atazanavir and raltegravir in combination with lamivudine or emtricitabine may     be a well tolerated and effective NNRTI-, and ritonavir-sparing regimen that could be an     attractive option for both first and second line (after NRTI/NNRTI failure) treatment     regimens.   "
235996|NCT00943553|"     The purpose of this study is to evaluate the efficacy and safety of decitabine when used     before chemotherapy to treat leukemia in pediatric patients. The study will also evaluate the     ways decitabine is affected or changed when used in the human body.   "
235997|NCT00943566|"     The study hypothesis is that the safety and efficacy of sufentanil following transdermal     application is comparable to sustained release morphine sulphate tablets in patients with     chronic pain due to cancer.   "
235998|NCT00943579|"     This is an open-label extension study available only to subjects who completed an earlier     double-blind, placebo-controlled study of sapropterin in children with autism. During this     protocol, all subjects will be receiving brand-name Kuvan 20 mg/kg/day for 16 weeks; subject     who complete the first 16 weeks will have the option of continuing on Kuvan at the same dose     for up to 90 days after the last subject has completed the first 16 weeks of this protocol.     The purpose of the study primarily is to gather additional information on safety and efficacy     in this population.   "
235999|NCT00943592|"     This is a clinical research study designed to evaluate whether a conditioning regimen     consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine     supported by donor blood cells will result in rapid recovery and a high rate of long-lasting     remissions in patients with leukemia, lymphoma and myeloma.   "
236000|NCT00943605|"     The objective of this clinical study is to evaluate the incidence of partial skin necrosis     following modified-radical mastectomy with or without same-day (two-stage) reconstruction     with the PEAK PlasmaBlade 4.0; to monitor and record operative performance, post-operative     pain, drain output, and skin scarring following surgery; and to compare these endpoints to     the current standard of care (SOC).   "
236001|NCT00943618|"     The goal of this clinical research study is learn if the combination of Chantix (varenicline)     and Zyban (bupropion) is more effective at helping people to quit smoking than varenicline     when given alone. Researchers also want to learn if this drug combination can reduce cravings     and other negative symptoms of nicotine withdrawal better than varenicline does alone. The     safety of this drug combination will also be tested.   "
236002|NCT00943631|"     The purpose of this study is to assess the safety and the body's immune response (body's     defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and     elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no     history of H1N1 infection or vaccination. Two hundred individuals will be 18-64 years old,     and the other 200 will be greater than or equal to 65 years of age. Participants will be     randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1     vaccine; group 2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine     injections on days 0 and 21 in the arm muscle. Study procedures include: medical history,     physical exam, maintaining a memory aid, and blood sample collection. Participants will be     involved in study related procedures for approximately 7 months.   "
236003|NCT00943644|"     This study is being done to test the ability of an investigational mammography camera to find     small tumors in patients' breasts.   "
236004|NCT00943657|"     The purpose of this study is to verify the immunogenicity and tolerance of a trivalent     seasonal influenza vaccine with strain composition according to World Heath     Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly     licensing application.   "
236454|NCT00953186|"     The purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers     as compared to placebo in patients with diabetes mellitus and chronic foot ulcers.   "
236005|NCT00943670|"     This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect     of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive     locally advanced or metastatic breast cancer and to make preliminary assessments regarding     the safety, tolerability, and efficacy of combined T-DM1 and pertuzumab in patients with     early disease progression.      The QT interval is a measure of time between the start of the Q wave and the end of the T     wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated     using Fridericia's correction; the QTcB interval is the QT interval as calculated using     Bazett's correction.   "
236006|NCT00943683|"     A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.   "
236007|NCT00943696|"     Tradition holds that the intake of different drinks with a meal has an important influence on     the digestion of food and postprandial symptoms such as fullness, bloating and satiety;     however this assumption have never been subjected to controlled study      A classic example is the Swiss cheese fondue. The intake of white wine, tea and cherry     schnapps (Kirsch) are often attributed either positive or negative effects on the     gastrointestinal tract.      In this study the effect of white wine vs. tea intake during and an alcoholic digestive     following a high fat, high calorie Swiss fondue meal on gastric emptying and visceral     perception will be investigated using a randomized, controlled study design.      The fondue will be labeled with non-radioactive 13C octanoate for assessment of gastric     emptying by breath-test.   "
236008|NCT00943709|"     RATIONALE: Controlling blood sugar levels may be effective in preventing infections in     patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia.      PURPOSE: This randomized phase I trial is studying how well controlling blood sugar levels     works in preventing infection in patients with acute myeloid leukemia or acute lymphoblastic     leukemia.   "
236009|NCT00943722|"     This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human     papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent     participants between 9 and 15 years old and demonstrate the consistency of the manufactured     vaccine through assessment of 3 different final manufacturing process lots of V503.      The primary hypotheses are as follows:        1. The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys          and girls 9 to 15 years of age and young women 16 to 26 years of age is generally          well-tolerated.        2. 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and          adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV          type compared to young women 16 to 26 years of age who are seronegative at Day 1 and          polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type,          as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers          (GMTs) at 4 weeks post-dose 3.        3. The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent          and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant          HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and          PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6,          11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.        4. Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine          induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33,          45, 52, and 58 GMTs at 4 weeks post-dose 3.   "
236010|NCT00943735|"     The primary objective of the study is to assess the level of medication adherence observed     among subjects receiving a specific combination of education and support materials (YourWay     plan) along with a prescription for fesoterodine.   "
236020|NCT00943865|"     Obese patients with metabolic syndrome without diabetes or ischemic heart disease were     randomized to three lifestyle interventions: 1. hypocaloric tailored diet with standard     recommendations 2. pragmatic healthy style diet adapted to brazilian habits with portion     control and pedometers to perform 10000 steps daily recorded or 3. pragmatic healthy style     diet adapted to brazilian habits with portion control plus fitness three times a week under     direct supervision. The main outcome was brachial reactivity, a surrogate marker of     atherosclerosis, and secondary outcomes were cardiometabolic profile, arterial pressure and     anthropometric measures: weight,waist circumference and bioimpedanciometry to access fat     proportion and insulin sensitivity.   "
236011|NCT00943748|"     Few available drugs can slow the progression of neurodegenerative pathologies such as     Parkinson's disease (PD). One of the recent hypotheses concerning the reduction of oxidative     stress and neuron death features a harmful effect of iron, which may reach abnormally high     levels in the substantia nigra (SN) pars compacta (iron overload has been seen in the     substantia nigra in parkinsonian patients and in the     1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) mouse model of PD). Iron overload is     harmful because it reacts with hydrogen peroxide (H2O2) produced during the oxidative     deamination of dopamine, generating hydroxyl radicals which then damage proteins, DNA and     phospholipid membranes and may be responsible for neuron death. The use of an iron chelator     (clioquinol) produces a reduction in neuron death in the MPTP mouse model. In humans, a     special, partially refocused interleaved multiple echo (PRIME) MR sequence has been used to     study the relaxation time (T2*) and quantify iron overload in the SN of PD patients and the     nucleus dentatus of patients with Friedreich's ataxia. T2* sequences have revealed a decrease     in iron overload following treatment with the chelator deferiprone, in parallel with a     clinical improvement in these patients. Furthermore, the very recent open label use of     deferiprone in rare serious, systemic, neurological iron overload diseases (Neurodegeneration     with Brain Iron Accumulation (NBIA)) has revealed a clinical improvement after 6 months, with     2 case reports from our group and another from an Italian group (Forni et al., 2008). The     safety of the low dosages of deferiprone (20 to 30 mg/kg/day) used in neurology appears to be     much greater than for the high dosages (75 to 100 mg/kg/day in 3 doses) used in hematology to     decrease post-transfusion iron overloads in thalassemia major.      Hence, the investigators wish to evaluate the effect of treatment with an oral iron chelator     which is capable of crossing the blood-brain barrier (deferiprone) on iron overload in the     SN(as assessed by the T2* sequence) with respect to the progression of clinical sign in PD.     It is expected a 6-month course of deferiprone able to produce a moderate reduction in iron     overload of the SN, associated with a drop in the motor handicap score. Depending on the     risk/benefit balance determined in this initial pilot study, a larger, multicenter     neuroprotection study could be envisaged.   "
236012|NCT00943761|"     This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated     interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV)     infection who did not achieve viral eradication while participating in a prior vaniprevir     clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184;     and MK-7009-029, NCT00954993).   "
236076|NCT00932555|"     The aim of this international prospective post-marketing surveillance study is to obtain data     on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE     Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.   "
236013|NCT00943774|"     Baroreflex sensitivity is integral to blood pressure regulation, and varies among healthy,     normotensive individuals. A reduced compensatory ability of baroreflex buffering in patients     with carotid denervation results in blood pressure variability and an elevated blood pressure     response to mental stress. Furthermore, 24-hour ambulatory blood pressure variability may     also be a significant and independent risk determinant of cardiovascular disease. It remains     unknown whether the degree of baroreflex sensitivity and ambulatory blood pressure     variability are predictive of the pressor response to sympathoexcitatory stress in healthy     humans. In this study the investigators propose a comprehensive evaluation of the     relationships among the pressor and forearm vasodilator response to sympathoexcitation,     ambulatory blood pressure variability, and baroreflex sensitivity in healthy normotensive     subjects. Ultimately this study will provide preliminary data and protocol development for     large-scale high resolution phenotyping in population-based trials aimed at determining the     functional relevance of candidate gene variation in intermediate physiological traits     pertinent to the pathogenesis of hypertension and cardiovascular disease.   "
236014|NCT00943787|"     The researchers plan to test the following hypothesis:      A good level of glucose control in Type 1 Diabetes Mellitus (T1DM) is dependent on two levels     of feedback from the body:        1. the transport of insulin through small blood vessels: suggesting that hypoglycemia leads          to increased insulin sensitivity which then causes recurrent hypoglycemia;        2. the endocrine level, defined as insulin-glucose interaction and hormonal          counter-regulation.      The researchers plan to investigate the relationships between hypoglycemia, insulin     transport, and counter-regulation. This study will ultimately lead to a better understanding     of risk for recurrent hypoglycemia.   "
236015|NCT00943800|"     The primary objective is to assess the rate of engraftment with combined haploidentical-cord     blood transplantation. The secondary objective is to evaluate the incidence and severity of     acute and chronic graft-versus-host disease (GVHD).   "
236016|NCT00943813|"     At Memorial Sloan-Kettering Cancer Center the investigators want to provide the best care to     their patients. One way to do this is to evaluate the ways that doctors communicate with     patients. To this end, the Department of Psychiatry and Behavioral Sciences runs a     Communication Skills Training and Research Laboratory. One goal of this laboratory is to     evaluate doctor-patient communication and provide training in how to improve the quality of     this communication.      Invitation to participate in this pilot project does not mean that a problem with     communication has been identified in your doctor's practice. Rather, it is because your     doctor and the fellow working with your doctor have agreed to cooperate with us as the     investigators develop strategies to train physicians, nurses and other clinical personnel to     communicate with cancer patients in as effective and sensitive a manner as possible.   "
236017|NCT00943826|"     This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the     current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide     followed by adjuvant temozolomide) as compared to the current standard of care alone.     Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram     (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with     radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus     temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6     weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10     mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4     week cycle) for 6 cycles of maintenance treatment or until disease progression or     unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab     (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study     treatment was until disease progression.   "
236018|NCT00943839|"     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients     with kidney cancer.   "
236019|NCT00943852|"     This study will qualify a functional model that can measure central blood pressure and     vascular compliance effects through noninvasive means.   "
236047|NCT00944216|"     Keratosis pilaris (KP) is a benign skin condition that often is very frustrating for the     patients and treating physicians. The investigators are interested to see if the study     product is effective in treating moderate to severe KP.   "
236021|NCT00943878|"     The purpose of this study is to assess the safety and immune response (body's defense against     disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study     will help determine how the H1N1 flu shot should be given with the seasonal flu shot to make     it most effective. Participants will include up to 850 healthy adults, ages 18 and older.     Participants will receive 2 H1N1 vaccines in addition to placebo (inactive substance) and the     seasonal flu shot over 3 study visits about 21 days apart. Study procedures include: medical     history, physical exam, maintaining a memory aid, and blood sample collection. Participants     will be involved in the study for about 8 months.   "
236022|NCT00943891|"     1. To determine the association between LVD and clinico-pathologic variables in archived          colorectal cancer and Nasopharyngeal carcinoma specimens        2. To determine the association between VEGF-C,-D expression with COX-2 expression and          clinico-pathologic variables in colorectal cancer and Nasopharyngeal carcinoma        3. To determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma          Lymphangiogenesis and factors modulating lymphangiogenesis are associated with          clinico-pathological outcome in Nasopharyngeal carcinoma and colorectal cancer.          Celecoxib down-regulates lymphangiogenesis Archival colorectal cancer and Nasopharyngeal          carcinoma tumor specimens will be obtained from the Department of Pathology. To          determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma, the          investigators intend to analyze archived specimens collected in a previously conducted          study. Colorectal tumor and nodal specimens and Nasopharyngeal carcinoma primary will be          examined for MVD, LVD and growth factor expression using established haematoxylin and          eosin and immunohistochemical techniques. Quantification of LVD and MVD shall be          performed by two pathologists blinded to clinico-pathological variables using          standardised methods.   "
236455|NCT00953199|"     The purpose of this study is to determine if lidocaine is effective in reducing the incidence     of post-ERCP pancreatitis.   "
236023|NCT00943904|"     Sacral nerve stimulation (SNS) implantation is a minimally invasive procedure which has     current FDA approval for urinary urge incontinence, urgency-frequency syndrome and     non-obstructive urinary retention, and has been available in the United States since 1997.     The SNS delivers non-painful, mild electrical pulses to the sacral nerves to modulate the     reflexes that influence the bladder, sphincter, and pelvic floor to improve or restore normal     voiding function. While SNS has been shown to have efficacy for the aforementioned     conditions, the exact mechanism of action is unknown, but it is believed to work primarily     through the somatic afferent system in promoting inhibitory reflex pathways to facilitate     urine storage. The degree of stimulation is thought to be at a level that only evokes a     sensory and not a motor response; however this has not been tested.   "
236024|NCT00943917|"     The purpose of this study is to determine safety, efficacy and tolerability of various doses     of ITCA 650 in subjects with type 2 diabetes.   "
236025|NCT00943930|"     This study is designed to investigate the associations among marijuana's discriminative     stimulus, reinforcing, subjective (e.g. craving) and physiological effects, and to assess the     relative ability of oral THC to block these effects.   "
236026|NCT00943943|"     The goal of this clinical research study is to learn the most tolerable dose of Nexavarâ     (sorafenib) when given in combination with Mobozilâ (plerixafor) and Neupogenâ (filgrastim)     to patients with AML. The safety of this combination will also be studied.      Funding Source - FDA OOPD   "
236027|NCT00943956|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Androgens can cause the     growth of prostate cancer cells. Antihormone therapy, such as bicalutamide and leuprolide     acetate may lessen the amount of androgens made by the body. Radiation therapy uses     high-energy x-rays to kill tumor cells. Giving everolimus together with bicalutamide,     leuprolide acetate, and radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when     given together with bicalutamide and leuprolide acetate in treating patients with high-risk     locally advanced prostate cancer undergoing radiation therapy.   "
236028|NCT00943969|"     The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the     most frequently surgical methods performed and combines restrictive and malabsorptive     procedures. Different data suggest that this surgery may modify drug absorption and we think     it would be clinically relevant to describe the consequences of gastric bypass on drug     systemic exposure in obese patients, since no data on the comparison between the     pharmacokinetics (PK) of a drug before and after surgery are available and help to predict     the drugs posology.The investigators decided to study the morphine because there is a lack of     information about the PK, pharmacodynamics (PD) et pharmacogenetics (PG) of morphine in obese     subjects, in contrary with anaesthetic drugs. This is a drug with a narrow therapeutic range     frequently prescribed in obese patients.   "
236029|NCT00943982|"     Background:        -  Uveitis is a serious inflammatory condition that affects the eye and can cause vision          loss. A common secondary problem associated with uveitis is macular edema (swelling).          The macula is the part of the eye that is important for central vision, and swelling of          the macula can lead to further vision loss. This condition is usually treated by          medicines that target the immune system, but these medicines sometimes do not work or          may cause side effects.        -  Interferon gamma-1b (Actimmune(Registered Trademark)) is a bioengineered protein that          can alter the way inflammatory cells work in the immune system. Interferon gamma-1b is          given as an intramuscular injection; however, this study will use the drug as an eye          drop. This study represents the first time that interferon gamma-1b is given as an eye          drop. Researchers hope that interferon gamma-1b will treat macular edema by decreasing          the swelling in the back of the eye.      Objectives:      - To investigate the safety and effectiveness of treating uveitis-associated macular edema     with interferon gamma-1b.      Eligibility:      - Individuals 18 years of age and older who have been diagnosed with macular edema associated     with uveitis (in one or both eyes) for at least 3 months.      Design:        -  Participants will have three planned clinic visits during this study over the course of          2 weeks.        -  All participants will have a medical history and eye examination.        -  When receiving the drops, participants will have optical coherence tomography (a          detailed scan of the retina) 60 minutes and 30 minutes before the drops; upon receiving          the drops; and 30, 60, and 120 minutes after receiving the drops.        -  After receiving the drops, participants will have another eye examination, blood drawn          for samples, and further scans.        -  Participants will be asked to return to the NIH Clinical Center 1 week after receiving          the drops for an evaluation....   "
236060|NCT00932347|"     The purpose of this study is to determine effect of Mouthwash containing Camellia sinensis     extracts on oral malodor and gingival inflammation in gingivitis subjects.   "
236094|NCT00932828|"     Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is     to produce a new treatment that would benefit young subjects who have recently been diagnosed     with peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and     changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).   "
236030|NCT00943995|"     Hypotheses:        1. The provision of thrice weekly subcutaneous (SQ) recombinant growth hormone (rGH)          therapy to children receiving in-center hemodialysis (HD) will result in improved          growth.        2. The provision of thrice weekly SQ rGH therapy to children receiving in-center HD will          result in improved lean body mass, nutritional status and quality of life.      TIW rGH treatment regimen (0.35 mg/kg/week divided into 3 doses, each dose being given at the     conclusion of the dialysis treatment) for up to 2 years; growth response, Dual energy X-ray     absorptiometry (DEXA), and quality of life (QOL) will be measured. The goal is to enroll 20     children who are Tanner 1 with decreased height SDS and/or decreased height velocity standard     deviation scoreS (SDS).      If this therapy is demonstrated to be efficacious and improves growth and QOL, this therapy     could be easily implemented for all eligible children on HD, since parental acceptance should     be better without having to administer the rGH at home and compliance for the child will be     assured.      The investigators thus propose an important study that has the ability to advance their     understanding and provide evidence for the best methods to promote growth in children on     dialysis. The results of this study will result in important information that will be of     value to the entire pediatric nephrologist community, including health care professionals,     patients, and families. In a real sense, this study will build on the 2006 Consensus     Conference guidelines for evaluation and treatment of growth failure in children with chronic     kidney disease (CKD). This will provide evidence for critical management decisions that can     help insure better growth opportunities to more children with CKD.   "
236077|NCT00932581|"     The purpose of this study is to examine whether scores on questionnaires that rate how much     Parkinson's Disease (PD) has slowed movements of the body differ when the order of the     questions are changed. The consistency and accuracy of the questionnaires will also be     examined. It is hypothesized that there will not be a difference.   "
236031|NCT00944008|"     The primary objective is:        -  To determine the efficacy and safety of DepoCyte®, as the only intrathecal (IT)          prophylaxis of neuromeningeal relapse for patients between 16 and 30 years old diagnosed          with acute lymphoblastic leukemia of standard risk treated with the PETHEMA LAL-RI-08          Protocol Chemotherapy schedule.      The secondary objectives are:        -  To evaluate the tolerability of IT DepoCyte® as CNS prophylaxis of CNS via IT for          patients between 16 and 30 years old with ALL of standard risk.        -  To compare the frequency of relapse in CNS for patients between 16 and 30 years old with          standard risk ALL treated with the PETHEMA LAL-RI-08 Protocol Chemotherapy schedule and          receiving DepoCyte® as the only IT CNS prophylaxis, with that observed in an historic          group of patients of identical risk that were treated with the PETHEMA LAL-RI/96          protocol (same systemic chemotherapy and double administration of triple intrathecal          chemotherapy)        -  To evaluate the frequency of systemic relapses of standard risk ALL patients between 16          and 30 years old treated with the PETHEMA LAL-RI-08 Protocol and who receive DepoCyte®          as the only IT prophylaxis of CNS involvement and to compare with those observed in the          identical risk patients treated with PETHEMA LAL-RI/96 protocol (same systemic          chemotherapy and double administration of triple IT chemotherapy)   "
236032|NCT00944021|"     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral     administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly     diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive     standard TB treatment.   "
236033|NCT00944034|"     This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of     a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously     primed with rMenB+OMV NZ according to two different three-dose immunization schedules in     infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will     also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following     the two different immunization schedules, in order to identify the optimal timing for     boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12     (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort     of subjects enrolled). These subjects will generate data for assessing the safety and     immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls     for a descriptive comparison of antibody persistence and booster responses for the other     groups.   "
236034|NCT00944047|"     The purpose of this study is to find out if there is a benefit of adding Herceptin     (trastuzumab) to standard chemotherapy in this type of breast cancer.   "
236035|NCT00944060|"     1) to evaluate treatment fidelity of DRRP: study design, training of interventionists,     delivery and receipt of the intervention, and application of the intervention in real-life     settings; 2) to identify successful strategies for participant recruitment and maintaining     active participation; 3) to collect and analyze preliminary indicators of DRRP's effect on     dietary intake, physical activity, stress responses, and body weight; and 4) To evaluate     sample representativeness of the target audience, implementation and acceptability of DRRP,     and attrition rate.   "
236036|NCT00944073|"     The purpose of this study is to assess the safety and the body's immune response (body's     defense against disease) to an experimental H1N1 influenza vaccine. Up to 650 healthy     volunteers from three age groups (greater than or equal to 6 months to less than 36 months,     greater than or equal to 36 months to 9 years, and 10 - 17 years) with no history of     influenza H1N1 2009 influenza infection or influenza H1N1 2009 vaccination will participate.     Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups.     Group 1 will receive 15 mcg of vaccine; Group 2 will receive 30 mcg of vaccine. Participants     will receive vaccine injections on Days 0 and 21 in the arm or thigh muscle. Study procedures     include: medical history, physical exam, maintaining a memory aid, and blood sample     collection. Participants will be involved in study related procedures for approximately 7     months.   "
236037|NCT00944086|"     In This Study, Our Goal is to Compare the Effects of Recruitment Manoeuvre Which is Applied     With Different Oxygen Concentrations on Oxygenation and Respiratory Mechanics During     Pneumoperitoneum   "
236038|NCT00944099|"     The purpose of this research is to test the effect of manipulating eating frequency on hunger     and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month     behavioral weight loss intervention.   "
236095|NCT00932841|"     The goal of this study is to determine whether the oral administration of the probiotic VSL#3     under randomized, placebo-controlled conditions will improve symptoms of irritable bowel     syndrome in children, safely.   "
236173|NCT00948337|"     The purpose of this study is to provide educational material to promote screening for second     primary cancer for the intervention group, or educational material to instruct appropriate     use of dietary supplement for the control group.   "
236039|NCT00944112|"     The most effective transfusion practice in critically ill ICU patients is unknown. Currently     the data is unclear as to whether a liberal or restrictive transfusion policy is of most     benefit to patients in the short and longer term. The aim of this study is to test the     hypothesis that liberal use of RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110     g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion     trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill     patients requiring prolonged ICU stay (≥4 days).      Patients will be randomised to one of two transfusion strategies on a 1:1 basis      Group 1 Restrictive RBC Transfusion group:      Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with     a target Hb concentration of 71-90 g/L during the intervention period.      Group 2 Liberal RBC transfusion group:      Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with     a target of 91-110 g/L during intervention. These patients will all receive a transfusion on     the day of randomisation.      Duration of Intervention:      Remainder of ICU stay or 14 days from randomisation, whichever is longer      Follow-Up      Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.      This is a feasibility study that will provide essential data to ensure the success of the     full trial. A qualitative study will also be carried out to explore potential reasons for     non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker     sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused     group associated with transfusions.   "
236040|NCT00944125|"     The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single     LV pacing (BiV pacing) to see if Dual LV pacing:        1. Improves the way the heart's left ventricle functions        2. Decreases the number of hospital and clinic visits for heart failure related symptoms        3. Slows the rate patients experience certain heart failure symptoms        4. Reduces uncoordinated heart contractions   "
236041|NCT00944138|"     Obesity plays a causal role for kidney disease incidence and progression. Moderate weight     loss reduces the high metabolic demands on the kidney and decreases proteinuria in both     diabetic and non-diabetic nephropathies. However, maintaining behavioral changes for weight     loss is very challenging, and common chronic kidney disease (CKD) co-morbidities such as     decreased exercise capacity only compound this difficulty. Moreover, no weight loss     medications have been adequately tested in adults with CKD and most are contraindicated in     this population. Mindful meditation or mindfulness in addition to other relaxation     techniques may help adults lose weight by interrupting learned behavior, curbing compulsive     eating, and reducing stress and appetite. Although mindful meditation and other relaxation     techniques have gained the attention of the mainstream media for obesity treatment,     scientific data on its efficacy remain limited. Due to the short duration of this study,     substantial weight loss in any participant is not expected. Instead, the primary purpose of     this study is to examine the feasibility of a randomized controlled trial of mindful     meditation relaxation techniques combined with standard care compared to standard care alone     for the treatment of obesity among Veterans with CKD.   "
236042|NCT00944151|"     Research study to determine if putting local anesthetic through one or two tiny tubes next to     the nerves that go to the area the patients are having surgery on (abdomen or pelvis), will     improve pain control following surgery. This study will also help determine if patients     require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with     their postoperative pain control.   "
236043|NCT00944164|"     The overall objective of this pilot is to demonstrate the feasibility of a low-cost     intervention targeting obesity prevention among children in a primary care setting.      Specifically, the investigators aim to answer the following questions:      Can the investigators recruit and retain patients using the methods proposed, and how easy or     difficult will this process be?      Can physicians deliver the proposed intervention messages in the time the investigators have     proposed?      Can the phone counselor reach participants and accomplish the goals outlined for these calls?      Can the investigators obtain the data proposed and within the proposed time frame?   "
236044|NCT00944177|"     -  Objective:             -  A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the               Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to               an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®,               Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects.        -  Study Design:             -  Randomized,single-dose,2-way crossover.   "
236045|NCT00944190|"     The proposed project will evaluate the efficacy of a telephone-delivered self-management     (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple     sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. It is     hypothesized that if the effects of these conditions are reduced, study participants will     demonstrate improved participation in the community and improved employment outcomes. This     project is important because the majority of persons with MS experience one or more of the     following secondary conditions: fatigue, pain, depression, and cognitive impairment. These     secondary conditions are not always readily apparent and constitute what has been described     by our Rehabilitation Research and Training Center as hidden disabilities. Secondary     conditions such as pain, depression, fatigue, and cognitive impairment frequently not only     cause distress in their own right but also affect employment, participation, and quality of     life. Having more than one often compounds the effect; the effect of all may be greater than     the sum of each individually (e.g. depression can worsen fatigue, and cognitive impairment     can worsen depression).      It is critical that this constellation of secondary symptoms be addressed using state of the     art techniques based on self-management training and that intervention effects be documented     with carefully controlled treatment efficacy studies.   "
236046|NCT00944203|"     This is an open label, prospective, test of superiority efficacy trial of Ipomea pes-caprae     ointment as an add-on therapy in patient with jellyfish dermatitis. Each patient will receive     standard medical treatment depend on the severity of the disease. The doctor will divide the     dermatitis area of each patient into two parts. Ipomea pes-caprae ointment will be applied as     an add-on therapy to the test area, while the ointment will not be applied to the control     area. Patients will be asked to come for follow up 6 times in the 28-days study period.     Primary objective is to compare the healing time of dermatitis in both areas.   "
236048|NCT00944229|"     A diet rich in Omega-3 (fish oil) reduces plasma triglycerides and the risk for ischemic     heart disease. Recently, a large trial evaluating treatment with Omega 3 in heart failure     patients suggested that omega 3 may lower the risk of death from CHF. The mechanism of this     potential benefit is not well understood.      Methods:      Forty patients will be enrolled in the study. Twenty patients will receive Omega 3 (lovaza 4     gm a day) and 20 patients will receive placebo. All subjects will have assessment of their     exercise capacity and blood vessel function before and after an 8 week treatment period.     About 4 table spoons of blood will be drawn throughout the study.      Expected results:      The investigators believe that omega 3 may improve the ability to exercise and improve blood     vessel function.   "
236049|NCT00932204|"     The purpose of the present study was to investigate possible therapeutic effects and safety     of sequentially combined low-frequency repetitive transcranial magnetic stimulation (rTMS) to     the right dorsolateral prefrontal cortex (DLPFC) and supplementary motor area (SMA) in     patients with treatment-resistant obsessive-compulsive disorder (OCD).   "
236050|NCT00932217|"     To evaluate the difference in the incidence of febrile episodes in patients undergoing stem     cells mobilization with chemotherapy and filgrastim versus chemotherapy and lenograstim.      A febrile episode will be considered as: body temperature > 38°C for two measurements in the     24 hours with an interval of 6 hours at least between the two measurements.   "
236051|NCT00932230|"     This study examines the effect of kinesiology tape on proprioception and postural control in     subjects with sub-acute and chronic ankle sprains/strain.   "
236053|NCT00932256|"     MAGNA intends to show that the combination of pseudoephedrine, chlorpheniramine, plus a small     amount of belladonna alkaloid is a comprehensive, safe and effective twice daily (BID) drug     treatment for seasonal allergic rhinitis (SAR) patients with post-nasal drip (PND). The phase     1 single-dose trial will consist of 21 subjects: 1) to gather pharmacodynamic measurements     and blood levels of active ingredients over 12 hours; 2) To report subjective scores by     subjects rating efficacy of single dose of STAHIST; 3) To report any side effects or adverse     drug reactions and rate the severity of incidence.   "
236054|NCT00932269|"     This is a randomized cross-sectional study of the Swedish population. Blood samples will be     collected from a subpopulation in order to estimate the age specific sero-prevalence of the     Swedish population for diseases included in the National Immunization Program (NIP), and to     affirm the population's protection against polio. To be able to recommend complementary     immunizations to immigrated children, a sub study focusing on foreign born teenagers will     also be done and compared to children of the same age born in Sweden.   "
236055|NCT00932282|"     The purpose of this study is to determine whether the addition of anti-IgE treatment will     make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut     allergy.   "
236056|NCT00932295|"     The study's aim is to develop a clinical model that can be used to measure the nicotine     delivery and tobacco/nicotine abstinence-suppressing capability of electronic devices that     are marketed as a means to deliver nicotine to cigarette smokers. The study will compare the     nicotine delivery, cardiovascular effects, and tobacco withdrawal suppressing effects of two     devices currently marketed in the U.S.: Crown Seven and NJOY. Specifically, the effects of     these devices will be compared with the effects of own brand cigarettes (positive control),     and an abstinence condition (sham smoking; puffing from an unlit cigarette). The primary     hypothesis is that the nicotine delivery, withdrawal suppression, and other effects of     electronic devices marketed as a means to deliver nicotine to smokers can be measured during     a period of acute exposure.   "
236057|NCT00932308|"     The investigators are involved in a research program to understand how different diets may     affect the risk of colorectal polyps and cancer. To that end, the investigators are     conducting a study of a western style diet versus a prudent style diet in which volunteer     subjects are provided a different diet for 2 separate 4 week periods at the Rockefeller     University Hospital. During one of these 4 week inpatient periods they receive a Western     style diet and during the other 4 week inpatient period they receive a Prudent style diet.     The investigators will determine changes within the colon as a result of the two different     diets. A more detailed description of the study is provided below.   "
236058|NCT00932321|"     This is a comparative study. The primary objective of the study is to assess the efficacy of     a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to     assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol     (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the     safety and tolerability of the product.   "
236059|NCT00932334|"     Title: Culturally tailored behavioral interventions to enhance living kidney donation/living     kidney transplantation Applicants: Johns Hopkins Medical Institutions, National Kidney     Foundation of Maryland Principal Investigator: Neil R. Powe, MD, MPH, MBA Address: 2024 E.     Monument Street, Suite 2-600, Baltimore, MD, 21205 Phone: 410-955-6953; Email:     npowe@jhmi.edu; Fax: 410-955-0476 Rates of kidney donation have been largely stagnant for the     past 10 years, resulting in large imbalances in numbers of persons on transplant waiting     lists and the number of persons receiving kidney transplants. Slow improvement in donation     and transplantation rates are exacerbated by ethnic/racial disparities in kidney transplants,     in which minorities, particularly African Americans, are far less likely to receive deceased     kidney transplants. Although living related kidney donation (LD) offers patients an     opportunity to bypass many barriers contributing to disparities in kidney transplantation     (e.g. waiting lists and immunological incompatibility issues), African Americans remain less     likely to receive living related kidney transplants (LRT), further exacerbating disparities     in transplant rates. Recent research demonstrates many ethnic minorities desire kidney     transplantation, but rates of patient-physician and patient-family discussions regarding     LD/LRT are suboptimal. Compared to Whites, African Americans have also been shown to have     disproportionately greater rates of culture-specific concerns (such as mistrust in health     care) that could impede them from seeking important medical therapies. It is unknown whether     culturally tailored behavioral interventions to enhance patient/family decision-making     regarding LD/LRT before the onset of end stage renal disease could improve rates of LD/LRT or     could narrow racial disparities in the receipt of transplantation. The primary goal of this     proposal is a) to use focus group methodology to develop culturally tailored educational     materials for patients/families considering LD/LRT and b) to perform a randomized controlled     trial to test the effectiveness of a culturally tailored social-worker led intervention     (using established behavioral problem-solving therapeutic techniques) in enhancing rates of     family communication, donor evaluations, and transplantation. The substantial experience of     our consortium, including the National Kidney Foundation of Maryland and the Johns Hopkins     Medical Institutions (Welch Center and the Medical Surgical Transplant Services in the School     of Medicine), in the evaluation/ implementation of donor/recipient educational programs as     well as the conduct of behavioral, epidemiologic and interventional studies related to     donor/recipient health and psychology provides a strong foundation for the conduct of this     study.   "
236061|NCT00932360|"     Fibromyalgia as a clinical syndrome is defined by chronic widespread muscular pain, fatigue     and tenderness with hyperalgesia to pressure over tender points. Pain associated with     fibromyalgia can interfere with daily function, work, and social activities. Thus, one of the     main treatments for patients with fibromyalgia must focus on pain relief to allow the person     to function more independently both at home and at work. Although the etiology of     fibromyalgia is unknown, there is clearly enhanced sensitization in the central nervous     system pain pathways as demonstrating by decreases in pressure pain thresholds, reduced     central inhibition, and enhanced temporal summation. Reducing pain in people with     fibromyalgia would help increase the patient's ability to return to work, perform activities     of daily living and thus improve the quality of life for the patient. Transcutaneous     electrical nerve stimulation (TENS) is a modality utilized in physical therapy that delivers     electrical stimulation through the skin and is used for both acute and chronic pain. TENS     works by reducing central excitability and increasing central inhibition. Thus, the     investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation     (TENS) to patients with Fibromyalgia (FM) will reduce pain, reduce central excitability by     restoring diffuse noxious inhibitory controls (DNIC), and reduce temporal summation and that     this decrease in pain and/or central excitability will improve function. The primary aim of     the study is to test the effectiveness of TENS on pain and central excitability in a     crossover design study for patients with Fibromyalgia with random assignment to three     treatments: no treatment control, placebo TENS and active high frequency TENS. A secondary     aim is to test the effect of decreased pain and central excitability on function in patients     with Fibromyalgia.   "
236062|NCT00932373|"     This is a phase I, multicenter, open-label, dose-escalation study of single-agent     trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive     metastatic breast cancer (MBC) who have previously received trastuzumab. The study will     assess the safety, tolerability, and pharmacokinetics of trastuzumab-MCC-DM1 and determine     the dose and schedule to be used in Phase II.   "
236063|NCT00932386|"     This study is being done to determine if the drug known as dexmedetomidine improves the way     we care for patients when their surgery involves the use of a tourniquet on the leg. A     tourniquet is sometimes used for lower leg or foot surgery to decrease the blood loss for the     patient and to make it easier for the surgeon to do his work.   "
236064|NCT00932399|"     The purpose of this study is to assess weight change in a population of Veterans with     amputations. Little is known about the how weight changes following an amputation. It is     widely believed that many patients experience weight gain following amputation. This study     aims to identify magnitude of weight changes following amputation and determine     characteristics associated with weight gain. Information on weight change trajectories would     be useful to better understand long-term health consequences associated with amputation and     to design and target interventions to encourage weight maintenance and general health     promotion for groups at high risk of weight gain.   "
236065|NCT00932412|"     This study is a phase II randomized multicenter study. Patients will be enrolled at time of     diagnosis and will receive one or two cycles of induction chemotherapy. Patients, without     indication of intensification by allogeneic stem cell transplantation and/or without HLA     (Human Leukocyte Antigen)-compatible donor, who attain a CR after one or two cycles of     induction chemotherapy, will be eligible for the study Clofarabine / Intermediate-Dose     Cytarabine (CLARA)versus High-Dose Cytarabine (HDAC)and will be randomized between 3 courses     of CLARA chemotherapy and 3 courses of HDAC chemotherapy as consolidation.      We will compare efficacy and toxicity among the two arms.   "
236066|NCT00932425|"     Atrial fibrillation (AF) is a common and treatable cause of ischemic stroke, but it can be     paroxysmal and asymptomatic, and therefore difficult to detect. Patients with stroke     routinely undergo 24 hours of continuous cardiac telemetry during hospitalization for stroke     as a means of excluding AF. Small studies indicate that extending the duration of monitoring     with portable outpatient telemetry devices detects more cases of AF. However, these studies     are small and lack control groups, and cannot demonstrate that prolonged cardiac monitoring     detects more cases of AF than routine clinical follow-up. The investigators therefore propose     a pilot study to determine the feasibility of randomizing patients to prolonged cardiac     monitoring or routine clinical follow-up. The investigators will enroll 40 consecutive adult     patients seen at the University of California at San Francisco (UCSF) Neurovascular service     with cryptogenic stroke or high-risk TIA (ABCD2 score 4 or greater). Enrolled patients will     be randomized in a 1:1 fashion. Group A will be assigned to wear an ambulatory cardiac event     monitor for 21 days. Group B will be discharged home without a monitor and will serve as     controls during routine clinical follow-up. The investigators' primary outcome will be     feasibility, defined as more than 80% of randomized patients completing full clinical     follow-up and more than 70% of cardiac monitoring if applicable. The investigators' secondary     outcomes will be diagnoses of AF at 90 days and 1 year and diagnoses of recurrent stroke at 1     year.   "
236067|NCT00932438|"     This is a multicentre, open labeled, controlled phase study designed to assess effectiveness     of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the     treatment of unresectable liver metastases in patients with colorectal cancer.   "
236068|NCT00932451|"     This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients     with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene.     This trial will also allow patients from a Phase 3 trial who received standard of care     chemotherapy (Study A8081007) to receive PF-02341066.   "
236069|NCT00932464|"     This study is being conducted to see if neratinib is absorbed, distributed, or eliminated     differently when administered in the fasting state versus after a high-fat meal.   "
236070|NCT00932477|"     The safety and tolerability of two new artificial tears will be compared to a     currently-available artificial tear in subjects with dry eye. Each subject will receive all     three products in a randomly assigned order. The subject will use one product at a time for a     duration of one week before switching to the next assigned product.   "
236071|NCT00932490|"     The primary aim of study is to:        1. Test the effectiveness of a tailored protocol in promoting adherence to oral          chemotherapeutic agents in adults receiving a new oral chemotherapeutic agent for          breast, colorectal, GIST, renal cell,and hepatocellular cancers.           Exploratory Aims:        2. Examine adherence to oral chemotherapeutic agents over time at 2, 4 and 6 months in a          sample of breast, colorectal, GIST, renal cell,and HPCC cancers patients.        3. Examine the effects of age, gender, caregiver availability, personal involvement in          health care, and depression on adherence to oral chemotherapeutic agents.   "
236072|NCT00932503|"     The aim of this study was to ascertain if the use of Vicryl plus® reduced the number of wound     infections after transverse laparotomy comparing to polydioxanon suture.   "
236073|NCT00932516|"     The purpose of this study is to examine the effectiveness of the South Beach Diet™ and South     Beach Diet™ products compared to a traditional calorie restricted diet.   "
236074|NCT00932529|"     Despite different pharmacological properties, the scientific evidence is inconclusive     regarding which of the first-line second generation antipsychotics (SGAs) should be preferred     for the individual patient suffering from psychosis. The limitations of the evidence base may     be related to the highly selected samples, short duration, and rigid experimental designs of     most randomized clinical trials of efficacy. Moreover a high proportion of the clinical     trials are drug company sponsored which could introduce funding bias. The purpose of this     non-commercially funded study is to investigate whether effectiveness differences exist among     the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are     used in a representative clinical setting. Eligible patients are those admitted to hospital     for acute psychosis and candidates for oral antipsychotic treatment. The investigators     hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse     sample representative of most patients admitted for symptoms of acute psychosis, differential     effectiveness among the SGAs could be disclosed when the patients are followed for up to 2     years. This could deliver valuable information regarding which SGA should be the starting     antipsychotic drug in order to facilitate the most beneficial outcome.   "
236075|NCT00932542|"     Assess the efficacy and safety of the topic use of an eutectic mixture of local anesthetics     for postoperative pain control of patients submitted to hemorrhoidectomy. Patients will be     operated and discharged at the same day in a day hospital clinic. During the fourteen days     recovery period, they will apply the study medication to the anal region 4 times daily. The     Visual Analog Pain Scale (VAS) will be answered twice daily. Patients will also take 100 mg     oral nimesulide twice daily and 50 mg tramadol on demand up to 4 times daily. The tramadol     demand will be tabulated. A rescue medication for analgesia will be provided (sodium     diclofenac IM).   "
236078|NCT00932594|"     The purpose of this study is to look at temporomandibular joint (TMJ) pressure as a guideline     to analyze the different treatments for temporomandibular disorder (TMD), and judge the     feasibility of the adjust TMJ pressure treatment and to reach a conclusion on the different     treatments for different types of TMD, and determine the new serial treatment of     temporomandibular disorders.   "
236079|NCT00932607|"     Objective of the study is to show, on an exploratory basis, that treatment with SUBLIVAC     Birch is also effective compared to treatment with Staloral Birch by means of reduction in     allergic symptoms during nasal provocation in subjects suffering from IgE mediated allergic     complaints triggered by birch pollen.   "
236080|NCT00932620|"     Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg result in low-density lipoprotein     cholesterol (LDL-C) reductions of approximately the same magnitude. However, the differential     effects of these two treatment options on small dense LDL-C (sdLDL-C) concentration have not     been assessed.      The aim of the present study is to compare the effects of simvastatin 40 mg versus     simvastatin/ezetimibe 10/10 mg on sdLDL-C concentration. The primary efficacy endpoint will     be changes in LDL subfraction profile (i.e. mean LDL particle size, sdLDL-C levels) at 3     months after treatment initiation.   "
236081|NCT00932633|"     Infants with congenital heart disease (CHD) requiring surgery frequently have brain injury     seen on magnetic resonance imaging (MRI). This occurs in approximately 40% of these newborns,     and even though these are full-term infants, the injury seen closely resembles the same form     of brain injury that can be seen in premature babies. Much like premature newborns, infants     with CHD also have long-term neurodevelopmental problems (in over 50%).      The investigators do not know why infants with CHD get this specific form of brain injury.     One risk factor is felt to be the inflammation that occurs in response to heart-lung bypass     (cardiopulmonary bypass, or CPB), a necessary feature of open-heart surgery. Newborns have a     stronger inflammatory reaction to CPB than older children or adults. The investigators do     know from animal experiments and other human data that inflammation can be harmful to the     developing brain.      The investigators hypothesize that children with CHD requiring surgery as a newborn have     brain injury due to toxicity from the inflammatory response. The investigators will test this     by enrolling newborns undergoing heart surgery to measure markers of inflammation, measure     brain injury by MRI, and then test their developmental outcome at 1 and 2 years of age.      An association between inflammation and injury might impact what medicines are chosen to     protect the brain in future studies, even in other populations such as preterm infants.   "
236082|NCT00932646|"     The study is intended to characterize the lung function profile of BI1744 in COPD patients     where patients will perform pulmonary function tests at regular intervals for 24 hours at the     end of a 6 week treatment period. Each patient will receive all four treatments.   "
236092|NCT00932776|"     Patients undergoing intubation and mechanical ventilation require removal of secretion by     means of trachoebronchial suctioning. Timing of the procedure is mainly based on clinical     parameters. TBA Care® is a new commercially available device designed to generate a signal     when secretions are present in the respiratory tract of intubated patients, thus indicating     the need for endotracheal suctioning only when necessary and prior to clinical deterioration.     In a prospective randomized trial in intubated and mechanically ventilated patients of a     general ICU the researchers investigated the efficacy of TBA Care® in detecting the presence     of retained secretions compared to the standard indicators.   "
236093|NCT00932802|"     The observation period for each patient covered an initial treatment period with Avelox® plus     optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician     documented data at any initial visit (baseline) and at least one short-term follow-up visit     (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were     documented, and a patient questionnaire was filled in.   "
236199|NCT00948675|"     The purpose of this study is to compare the regimens of pemetrexed, carboplatin with     pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance     in participants with Stage IV nonsquamous non-small cell lung cancer.   "
236083|NCT00932659|"     Hemodialysis patients have a rate of fatal arrhythmias that is 40 times greater than the     general population, but the causes and types of fatal arrhythmias they experience is unclear.     The purpose of this prospective observational cohort study is to capture and characterize     occult arrhythmias which occur in hemodialysis patients over a 6 month period. After informed     consent and baseline assessment, 30 adult hemodialysis patients without a prior history of     cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device     (REVEAL, Medtronic). Three followup visits will be scheduled to download device data and     quantify the number of potentially malignant arrhythmias which occur in study subjects during     the 6 month period. Additionally, captured events will be monitored remotely via regular     patient initiated transmission of device data every 2 weeks. Any serious occult arrhythmias     detected will be immediately acted upon with a predefined management algorithm. Descriptive     data and simple proportions will be used to describe the incidence and types of arrhythmias     among the study cohort. Risks of this study include 1) potential loss of patient     confidentiality 2) risks related to insertion of device including pocket hematoma, device     infection, pain and discomfort secondary to procedure. These will be minimized by strict     security measures to protect each patient's protected health information (PHI), preprocedural     screening and insertion of monitoring devices by highly trained operators, and frequent     careful direct patient followup.   "
236084|NCT00932672|"     This study will test the hypothesis that a low-carbohydrate Atkins diet will prevent or at     least minimize the metabolic consequences of androgen deprivation therapy (ADT).   "
236116|NCT00933114|"     Dynamic contrast-enhanced (DCE) - magnetic resonance imaging (MRI), diffusion-weighted     (DW)-MRI, and fludeoxyglucose - positron emission tomography - computed tomography     (FDG-PET-CT) are three modalities that generate non-invasive, functional images of tumors and     normal tissues based on physiologic properties including perfusion, vascular permeability and     glucose metabolism. Demonstrating that these parameters are associated with clinical outcome,     either efficacy or toxicity, could enhance the ability to select patients for different     treatment strategies and improve the therapeutic ratio.   "
236499|NCT00953784|"     This is a comparison, at this VA Hospital, of standard operating room management in     colorectal surgery to a more rigid management using an additional five previously tested     treatments to determine if this changes the rate of post operative wound infections.   "
236085|NCT00932685|"     Preoperative anxiety is characterized by subjective feelings of tension, apprehension,     nervousness and worry. In children, preoperative anxiety is reported to result in     postoperative negative psychological effects, including nightmares, eating problems and     increased fear of doctors. Previous studies have assessed anxiety in children during the     preoperative period and the effects of premedication and parental presence. Midazolzam has     been shown to reduce preoperative anxiety in children but post operative recovery maybe     delayed for children undergoing a short operative procedure. Distraction may be particularly     helpful in children ages 6-12 as these children are curious about their environment. An     association between preoperative anxiety and emergence agitation has been suggested.     Emergence agitation in children is not well understood but is a frightening experience for     child and parent. A previous study demonstrated the efficacy of hand held video games used as     an interactive distraction to allay preoperative anxiety. The purpose of this study is to     treat preop anxiety with premedication, or video game and to evaluate the impact of these     interventions on the incidence and severity of emergence agitation.   "
236086|NCT00932698|"     This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD)     and disease response of IXAZOMIB administered orally in patients with relapsed and/or     refractory multiple myeloma.   "
236087|NCT00932711|"     The purpose of this study is to determine if educational intervention is effective in     reducing exacerbations of chronic obstructive pulmonary disease in patients with low-risk     disease.   "
236088|NCT00932724|"     This trial is designed as a phase II evaluation of the effect of CY-503 or placebo on     progression free survival (PFS) defined as the time from start of treatment until the     objective observation of progressive disease (PD) or death from any course in patients with     chemotherapy-refractory metastatic colorectal cancer.   "
236089|NCT00932737|"     The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB)     20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment     of intensity of abdominal pain associated with cramping (APC) in the treatment of two     episodes.   "
236090|NCT00932750|"     The goal of this study is to establish the role of coffee mannooligosaccharides (MOS),     provided in a beverage format, on body weight regulation. Overweight and obese men and women     will be randomized to one of 2 groups: placebo or MOS beverage. They will be required to     consume 2 beverages/day for the duration of the 2 phases of the study. The MOS beverage will     provide 2 g of MOS (total of 4 g/d). This dose level has been found to be well tolerated and     safe. In the first phase, subjects will be counseled once monthly on a nutrition-related     topic on an individual basis. They will be asked to maintain their regular eating and     exercise habits for the duration of the 12 week period. An 8-week washout period will follow     during which time they will not be required to consume the beverages. The second phase of the     study will be a weight loss phase. For this phase, subjects will be re-randomized and may     consume the alternate or the same beverage as the first phase, depending on the outcome of     randomization. During this phase, they will undergo group counseling on a weekly basis.     Counseling sessions will focus on weight loss and ways to achieve moderate weight loss of     approximately 1-2 lbs/week. Measurements will be taken at the beginning and end of each     phase. This study will allow us to determine whether MOS helps maintain body weight and     prevent weight gain (first phase) and whether it helps to stimulate weight loss (second     phase). The results will allow us to find ways in which overweight and obese individuals can     incorporate beverages in their diets that will help promote weight loss.   "
236091|NCT00932763|"     -  Objective:             -  The objective of this study was to assess the relative bioavailability of two               formulations of immediate release amlodipine 10 mg under fasted conditions, in               healthy subjects.        -  Study Design:             -  This was an open-label, single-dose, 2-treatment, 2-period, randomized, crossover               study.Twenty-two healthy subjects were enrolled. Subjects who successfully               completed the screening process checked into the research center the night before               first dose. Subjects who continued to meet inclusion/exclusion criteria the morning               of dose were assigned a subject number, based on the order in which they               successfully completed the screening process and procedures as outlined in the               study protocol. Subjects were randomly assigned to a treatment sequence and               received two separate single-dose administrations of study medication, one               treatment per period,according to the randomization schedule. Dosing days were               separated by a washout period of at least 14 days. Subjects received each of the               treatments listed below during the two treatment periods following an overnight               fast of at least 10 hours: amlodipine by Torrent Pharmaceuticals Ltd. and Norvasc               by Pfizer, Inc.   "
236096|NCT00932854|"     Enlarged glands in the chest (mediastinal lymphadenopathy) is a common problem and may have a     variety of different causes. In the past an operation (mediastinoscopy) was required to     diagnose the glands. Endobronchial ultrasound (EBUS) is a new procedure that may be able to     diagnose these glands without the need for mediastinoscopy. The REMEDY trial aims to examine     whether EBUS can reduce the number of mediastinoscopies and healthcare costs in patients with     enlarged glands in the chest.   "
236097|NCT00932867|"     Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension,     who do not tolerate ACE inhibitoR treatment   "
236098|NCT00932880|"     -  Objective:             -  The objective of this study was to compare the rate and extent of absorption of the               test formulation, amlodipine besylate 10 mg tablets (Torrent Pharmaceuticals Ltd.),               with that of the marketed reference product, Norvasc® 10 mg tablets (Pfizer, Inc.),               when administered under fed conditions.        -  Study Design:             -  This was an open-label, randomized, two-way crossover study in which 18 healthy               subjects were scheduled to receive a single dose of each of two treatments in two               assigned dosing periods. Each dose administration was separated by a minimum 14-day               washout period.   "
236099|NCT00932893|"     This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus     pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific     gene profile involving the ALK gene after failure of one previous chemotherapy regimen that     included one platinum drug.   "
237302|NCT00964028|"     This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a     three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.   "
236100|NCT00932906|"     This study is a prospective, randomized trial that compares the effectiveness and retention     of four different training methods for the use of an AED:      A. Traditional instructor based learning;      B. The use of a personal manikin with a DVD training to practice the necessary AED skills;      C. The use of a personal manikin with a DVD training to practice the necessary AED skills and     additional scenario training;      D. Watching a 2.5 minutes DVD which shows the use of an AED.      It is hypnotised that there are no differences between these training methods, in which case     method D is most efficient to reach large number of people to learn BLS/AED skills.      There are two interesting target groups to reach:        1. Younger people, as they might give the highest interest after training, as they normally          live longer.        2. Older people as they are member of the most important group in risk and have therefore a          higher change of being a witness of cardiac arrest.      As there might be differences in the results between different training methods than can be     related to age, each training group is distinguished to three different groups:        1. 21 years of younger;        2. between 21 and 50 years;        3. older than 50 years.      It is hypnotised that there are no differences between younger and older students within each     of the four training methods.   "
236101|NCT00932919|"     The purpose for this study is to find out if Thought field therapy has the same effect as, or     better effect than, Cognitive therapy for Agoraphobia.   "
236102|NCT00932932|"     The purpose of the study is to find out if people with Prader-Willi syndrome have a     difference in the protein which changes inactive cortisone to the active stress hormone     cortisol.   "
236103|NCT00932945|"     Primary Objective:      To prove the safety of the gynecological formulation in normal conditions of use.   "
236104|NCT00932958|"     This protocol describes an observational study whose goal is to collect de-identified     Coronary CT Angiography (CCTA) acquisition factors and interpretations (findings) from     several hundred U.S. and international imaging facilities. The study uses an electronic data     capture tool to collect de-identified CCTA utilization parameters and clinical findings in     order to create a multi-center registry. This registry will be used for scientific analysis     and publication of pertinent medical trends such as CT utilization, radiation dose, and     common cardiovascular findings. The registry will be used to determine areas of interest for     future randomized controlled trials.      All data will be collected with patient identifiers removed and in complete accordance with     HIPAA regulations. All data will be analyzed in aggregate, thus further minimizing the risk     of patient confidentiality violations.   "
236105|NCT00932971|"     Randomized, double blind study comparing the efficacy of pegylated interferon-alfa2a plus     placebo versus pegylated interferon-alfa2a plus tenofovir for the treatment of chronic delta     hepatitis. 70 Patients will be randomized 1:1 into the two groups. Treatment duration: 96     weeks. Follow-up: 24 weeks. Long-term-follow-up: until week 358.   "
236106|NCT00932984|"     Primary Objective:      To demonstrate the absence of photoirritation and potential photosensitization of the product     Dermacyd Silver Floral.   "
236107|NCT00932997|"     RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the     psychological and physical impact of breast cancer and increase awareness of available     resources. It is not yet known whether survivorship booklets are more effective when given     alone or together with individual telephone sessions in informing breast cancer survivors.      PURPOSE: This randomized clinical trial is studying individual telephone sessions given     together with survivorship booklets compared with survivorship booklets alone to see how well     they work in increasing knowledge about the impact of breast cancer in African American and     Latina breast cancer survivors.   "
236108|NCT00933010|"     The aim of the study is to assess the prevalence of Metabolic Syndrome in Italy on a regional     basis, defined according to NCEP/ATPIII Guidelines criteria.   "
236109|NCT00933023|"     Topical steroids are used as treatment for non-retractile foreskin in children for decades,     but, there are disagreement among physicians about the optimum potency of the agent used.     This study is designed to determine any difference in the beneficial effects of mild versus     potent topical corticosteroids in treatment of non-retractile foreskin in children.   "
236110|NCT00933036|"     The clinical trial is being conducted to evaluate the performance of the Crosstrees System in     reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and     kyphoplasty.   "
236128|NCT00938587|"     This study will investigate the safety and efficacy of an investigational drug, PF-04171327     on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids     while on background methotrexate. This study will also look at the response of chemical and     biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK     (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.   "
236111|NCT00933049|"     The investigators hypothesized that Oral amoxicillin (25mg/kg/dose bid) given to children     aged 2-59 months with pneumonia, would lead to better clinical outcome on day three in 89.9%     of the children compared to 77.0% of children receiving oral cotrimoxazole (8 mg/kg/dose     trimethoprim, 40 mg/kg/dose sulphamethoxazole). A double blind randomized controlled trial     was conducted in the Assessment Center of Mulago Hospital. Children with non-severe pneumonia     were randomized to receive either oral amoxicillin (25 mg/kg/dose) or cotrimoxazole     (trimethoprim 8 mg/kg and sulphamethoxazole 40 mg/kg) and followed up on day 3 and 5 of     treatment. The primary outcome measures were normalization of respiratory rate by day 3 of     treatment. Secondary outcome measures were antimicrobial susceptibility to cotrimoxazole and     amoxicillin.   "
236112|NCT00933062|"     The purpose of this study is to assess the pharmacokinetic profile, safety, and tolerability     of SRT2104 following administration of single and multiple oral doses (once a day for seven     days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state.   "
236113|NCT00933075|"     Primary Objective:      To demonstrate the absence of photoirritation and photosensitization potential of the product     Dermacyd Silver Frutal.   "
236114|NCT00933088|"     The aims of this study are to determine the differential coping strategies used by adolescent     daughters whose mothers have breast cancer, and how this relates to the stress responses they     exhibit.   "
236115|NCT00933101|"     The purpose of this study is to find out if diabetes damages the blood vessels of adolescents     with good diabetes control compared to adolescents with less optimal control.   "
236117|NCT00938444|"     This protocol is designed to evaluate the BRADA and ABILHAND questionnaires in rheumatoid     arthritis (RA) patients that will be treated with an effective therapy. Patients with     moderate to severe RA treated with tocilizumab will be asked to complete the BRADA and     ABILHAND questionnaires at screening, baseline, after 12 weeks and after 24 weeks of     treatment. All other assessments and questionnaires from daily clinical practice (such as the     global assessment of disease activity by the patient, the Health Assessment Questionnaire     (HAQ), the SF36 questionnaire, measurement of ESR and CRP and the DAS 28 calculation), will     also be used to evaluate these questionnaires.   "
236118|NCT00938457|"     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor     and cause less damage to normal tissue.      PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic     radiation therapy in treating patients with liver metastases.   "
236119|NCT00938470|"     This randomized phase II trial studies how well docetaxel, oxaliplatin, capecitabine,     fluorouracil, and radiation therapy works compared with fluorouracil when given together with     oxaliplatin and radiation therapy in treating patients with cancer of the esophagus or     gastroesophageal junction that has spread from where it started to nearby tissue or lymph     nodes. Drugs used in chemotherapy, such as docetaxel, oxaliplatin, capecitabine, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from dividing. Radiation therapy     uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination     chemotherapy) together with radiation therapy before surgery may make the tumor smaller and     reduce the amount of normal tissue that needs to be removed.   "
236120|NCT00938483|"     The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with     cow's milk allergy.   "
236121|NCT00938496|"     This is a prospective, open label NIS, which is to assess the efficacy of Zoladex in adjuvant     setting after operation in moderate to severe endometriosis patients.   "
236122|NCT00938509|"     The study will evaluate the efficacy of Ibuprofen administered as suppositories in the     treatment of fever in infants and children. Ibuprofen as suppositories is not yet registered     in Israel, although widely used in Europe.   "
236123|NCT00938522|"     The purpose of this study is to investigate the effect of cilostazol loading before planned     PCI on major adverse cardiac and cerebrovascular events in patients with coronary artery     disease.   "
236124|NCT00938535|"     This study will evaluate the efficacy of a behavioral intervention, designed to prevent     weight gain among overweight and low obese (25-34.9 kg/m2) Black women (aged 25-44), compared     to usual care.   "
236125|NCT00938548|"     The investigators hypothesize that pregabalin will decrease post-operative pain scores and     analgesic use following total mastectomy compared to placebo. The primary outcome will be     acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total     analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1     week and 1 month after operation.   "
236126|NCT00938561|"     Glomerular filtration rate (GFR) is widely accepted as the best index of kidney function in     health and disease, and accurate values are required for optimal clinical decision making and     in large-scale epidemiologic studies and clinical trials. Current recommended methods for     measuring GFR are expensive, cumbersome to administer and assay and requires urine collection     and administration of radioactive materials. The purpose of this study is to evaluate two     non-radioactive markers (iohexol and gadolinium) compared to urinary clearance of inulin and     iothalamate. The investigators hypothesize that plasma clearance of non-radioactive markers     will be unbiased compared to a gold standard and more precise than currently used urinary     clearance methods.   "
236127|NCT00938574|"     This is a phase I, prospective, open-label, single center, dose finding study with Atu027 (an     siRNA formulation) given as single treatment followed by repeated treatment (repeated     treatment phase: 8 treatments within 4 weeks) as therapy in subjects with advanced solid     cancer.   "
236129|NCT00938600|"     This is a preliminary study of oral vitamin D3 supplementation in pregnant and non-pregnant     women of reproductive age in Bangladesh. The primary objective of the study is to identify a     dose of vitamin D3 that can safely be administered during pregnancy to improve the vitamin D     status of the mother and infant.   "
236131|NCT00938626|"     RATIONALE: Giving chemotherapy followed by treated T cells before a stem cell transplant     stops the growth of cancer cells by stopping them from dividing or by killing them. After     treatment, stem cells are collected from the patient's blood and stored. High-dose     chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells     are then returned to the patient to replace the blood-forming cells that were destroyed by     the chemotherapy.      PURPOSE: This phase I trial is studying the side effects and best way to give treated T cells     followed by stem cell transplant in treating patients with multiple myeloma.   "
236132|NCT00938639|"     The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for     eliciting an immune response to H1N1 influenza in healthy adults.   "
236133|NCT00938652|"     The goal of this study was to determine the effect on overall survival and progression free     survival by adding iniparib (BSI-201/SAR240550) to the combination of gemcitabine/carboplatin     in adult patients with triple negative breast cancer (estrogen receptor (ER)-negative,     progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2     (HER2)-negative).      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact     mechanism has not yet been fully elucidated, however based on experiments on tumor cells     performed in the laboratory, iniparib is a novel investigational anti-cancer agent that     induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in     the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging     modalities in tumor cell lines. Investigations into potential targets of iniparib and its     metabolites are ongoing.   "
236156|NCT00944372|"     The objective of this study was to evaluate the effect of age (geriatric) and renal function     on the safety, efficacy and pharmacokinetics of OctreoScan at the recommended clinical dose     in this patient population.   "
236157|NCT00944385|"     According to TEG (thromboelastography), as maximum amplitude is increased the amount of     bleeding and transfusion and Cardiac enzyme is reduced by using ulinastatin.   "
236134|NCT00938665|"     The proposed study is designed to evaluate the performance of the COGNISION™ System as a tool     to assist physicians in diagnosing Alzheimer's Disease (AD) in real-world clinical settings.     The design of this study is guided by two overriding factors: 1) to optimize the performance     of the event related potentials (ERP) classifiers, the subjects making up the training sets     must be well characterized as to their clinical diagnosis, and 2) all ERP tests must be     performed and reproduced in real-world clinical settings.   "
236135|NCT00938678|"     This study compared the pharmacokinetics, pharmacodynamics and the safety of Pegfilgrastim     Hospira and Neulasta® following a single dose of 6 mg of each product administered     subcutaneously in Treatment Periods 1 and 2, respectively, in healthy volunteers.   "
236136|NCT00938691|"     Certain parts of the body, such as the chest, back, and shoulders, are notorious for     producing cosmetically poor scars after cutaneous surgery. While very little research has     been done to understand these poor outcomes, it is generally thought that increased tension     across the skin inherent to these body areas leads to significant widening of the final scar.     Historically, the only way to combat this tension was to support the deeper portion of the     wound with sutures that dissolve over several weeks. However, scars take many months to fully     develop their greatest strength. So even with the standard technique, wounds in areas of high     tension still show spreading of the scar with time. The investigators believe that these     wounds require an extended duration of support throughout the scar's maturation period. Until     recently, there did not exist a suture that could provide this long duration of support     without also carrying the risk of the body rejecting it. Recently, a new extremely long     acting absorbable biomaterial has been FDA approved for use as a suture. The investigators     plan to use this suture to test the theory that alleviating stress on high tension wounds     throughout the period which they gain their maximal integrity produces less scar spread and     ultimately better cosmetic outcomes.   "
236137|NCT00938704|"     To compare the efficacy and safety of two non-preserved artificial tears,     (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the     treatment of the signs and symptoms of dry eye disease.   "
236138|NCT00938717|"     The purpose of this study is to determine the safety and efficacy of linaclotide administered     to patients with Irritable Bowel Syndrome with Constipation (IBS-C).   "
236139|NCT00938730|"     The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150     in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and     tolerability data.   "
236140|NCT00938743|"     According available data individuals with ADHD are impaired in their driving ability which     can be improved by stimulant medication. The impact of the specific     noradrenalin-reuptake-inhibitor atomoxetine on driving ability of patients with ADHD has     never been studied so far.      The present study aims to evaluate the effects of atomoxetine treatment in patients with ADHD     on practical driving abilities which will be assessed with a standardized driving test, a     structured one-week driving diary and driving related neuropsychological processing     especially different aspects of attention and executive functions which will be assessed with     a neuropsychological test battery designed for the assessment of drivers fitness. A     functional magnetic resonance imaging (fMRI) - investigation will also be performed at the     beginning and after a 10-week treatment with atomoxetine. The study will be conducted in a     single-blind placebo controlled parallel group design in cooperation of the academic Adult     ADHD-outpatient clinics of the Central Institute of Mental Health, Mannheim and the Institute     of Legal and Traffic Medicine of the University of Heidelberg, Germany.      It is expected that treatment with atomoxetine will improve practical driving abilities and     driving related neuropsychological processing. It is expected that risk taking and impulsive     decision making will be reduced and sustained attention and overview of complex traffic     situations will be improved while driving.   "
236141|NCT00938756|"     RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer or meningeal     syndrome may help doctors identify biomarkers related to cancer.      PURPOSE: This clinical trial is studying cerebrospinal fluid samples in diagnosing     carcinomatous meningitis in patients with cancer or meningeal syndrome.   "
236142|NCT00938769|"     The goal of this study is to examine the effects of an enhanced caregiver training protocol     that not only teaches informal caregivers knowledge and skills for managing patient symptoms,     but also provides strategies for managing their own psychological distress. The investigators     anticipate this training will increase caregivers' self-efficacy and improve important     caregiver outcomes (depression, anxiety, burden, quality of life) and patient outcomes     (symptom distress/intensity, depression, anxiety, and quality of life). The study will     compare the effects of this protocol to an education control condition that equates for     interventionist time and attention.   "
236143|NCT00938782|"     Asses the effect of the use of Patient State Index (PSI) monitoring on difference in     emergence profiles in the elderly (age >65 yrs) population to develop a cost-benefit profile.      Assess differences in Quality of Life using the QoR-40 (a validated 40-item questionnaire on     quality of recovery from anesthesia) between the two treatment groups.   "
236144|NCT00938795|"     The goal of this study is to improve symptoms and quality of life for end-stage liver disease     patients awaiting a liver transplant and their caregivers by providing them with the     resources and tools to self-manage their complex concerns.   "
236158|NCT00944398|"     The purpose of the study is to evaluate the use of plasma zinc concentration for assessing     the impact of targeted zinc fortification programs.   "
236159|NCT00944424|"     Randomized phase III trial to determine the effectiveness of High dose versus Standard dose     of Vitamin D2 (Ergocalciferol) given with Docetaxel in patients with metastatic breast cancer   "
236160|NCT00944437|"     The aim of this study is to compare two methods of delivery of noninvasive mechanical     ventilation (NIV).      Since patient compliance and mechanical characteristics of the delivery devices are two     fundamental variables in the success of NIV during acute respiratory failure, our hypothesis     is that an improved patient-ventilator interface may improve the efficacy of therapy.   "
236161|NCT00944450|"     This study will establish that the MK0431 100 mg anhydrous formulation tablets are     bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.   "
236162|NCT00944463|"     The purpose of this study is to determine whether simvastatin is effective in the treatment     of advanced pancreatic cancer patients.   "
236145|NCT00938808|"     Obesity and osteoarthritis (OA) co-exist in an increasing part of the population.      The two diseases intertwine in several ways. The evolution in the population shows a tendency     towards deterioration of both by increasing general age and weight. The two diseases share     pathogenetic features and the development of one disease increases the risk of the other and     may be the onset of a vicious circle.      There is a link between treatments of these two diseases as well. There is now solid (gold)     evidence that by treating effectively the obesity of patients with co-occurring OA, the     functional status is dramatically ameliorated; the short-term results are equal to that of a     joint replacement. The long-term efficacy of a weight loss remains to be shown. OA is     definitely one of many diseases in which obesity must be taken seriously into account when     planning a correct treatment of patients. This trial is an extension of the former CAROT     trial NCT00655941. The participants of this trial are recruited for a prolongation of the     dietary intervention consisting of a group therapy with low-energy diet in a randomized, two     group (each n = 75 patients) study of maintenance of weight loss by continuing with     supplementary either 3 x 5 weeks dietary supplements only or once-daily supplement. The     hypothesis is that maintenance of the already induced weight loss is most efficiently ensured     by the once-daily program.   "
236146|NCT00944242|"     -  Objective:             -  To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited,               India, sertraline and Pfizer, Inc., USA (Zoloft) sertraline, administered as a               1X100 mg tablet, under fasted conditions.        -  Study Design:             -  Single-dose, open-label, randomized two-way crossover.   "
236147|NCT00944255|"     BACKGROUND. Polymorphisms occur in several genes encoding key enzymes in the folate pathway     may affect drug metabolism in patients with rheumatoid arthritis. Whether these genetic     variations contribute to differential responses to antifolate drug in patients with     rheumatoid arthritis (RA) remains to be investigated in the Taiwanese population.      OBJECTIVE. The goal of the present study is to investigate the interactions between genetic     variations in folate genes and the efficacy/side effects of anti-folate disease-modifying     anti-rheumatic drug in Taiwan.      DESIGN. A cross-sectional study involving patients with RA were enrolled from TCVGH. Disease     activity, drug efficacy and associated side-effects were assessed.      Genotypes in folylpoly-gamma-glutamate synthetase and reduced folate carrier were determined     by RFLP or pyrosequencing.   "
236148|NCT00944268|"     To evaluate the efficacy and tolerability of the combination use of Passiflora incarnata L,     Crataegus oxyacantha and Salix alba L in mild and moderate anxiety.      Clinical study phase III, multicenter, prospective, open.      Patients will be included in sufficient quantity to achieve the minimum number of 124     evaluable patients.   "
236149|NCT00944281|"     To assess zinc-related biochemical and functional responses among young Burkinabe children     with a presumed high risk of zinc deficiency who receive micronutrient products containing     different amounts of zinc, provided with or between meals.   "
236150|NCT00944294|"     Binodenoson (an experimental drug) and adenosine (an FDA-approved drug that is currently used     by doctors) are used to increase blood flow to the heart just like when a person exercises on     a treadmill. Using imaging techniques, this increased blood flow can help determine if areas     of the heart are not getting enough blood and oxygen during exercise. The purpose of the     study is to determine if binodenoson is as good as adenosine in determining if there are     areas of the heart not getting enough oxygen when blood flow to the heart is increased.   "
236151|NCT00944307|"     The purpose of this study is to test whether there is a drug interaction between raltegravir     (a medicine used to treat the human immunodeficiency virus or HIV) and antacids.   "
236152|NCT00944320|"     Polymorphisms occur in several genes encoding key enzymes in the folate pathway may affect     drug metabolism in patients with rheumatoid arthritis. Whether these genetic variations     contribute to differential responses to antifolate drug in patients with rheumatoid arthritis     (RA) remains to be investigated in the Taiwanese population.      Objective. The goal of the present study is to investigate the interactions between genetic     variations in folate genes and the efficacy/side effects of anti-folate disease-modifying     antirheumatic drug in Taiwan.      DESIGN. A cross-sectional study involving 100 patients with RA were enrolled from TCVGH.     Genotypes in methylenetetrahydrofolate reductase (MTHFR677C>T), tandem repeat polymorphism in     thymidylate synthase enhancer region (TSER) and folylpoly-gamma-glutamate synthetase     (FPGS1901T>C) were determined by RFLP or pyrosequencing.   "
236153|NCT00944333|"     Prospective, randomized, non-inferiority, multicenter, international study.In total 4000     patients (70 centers in Europe) with de novo lesions in native coronary arteries who meet the     eligibility criteria randomized to 6 versus 12 month dual antiplatelet therapies following a     second generation DES implantation.      Assuming that the true proportion of thrombotic events is equal to 2.3% for both regimens     (6-month and 12-month clopidogrel) 2000 patients for each treatment group are necessary to     demonstrate a non-inferiority of the 6-months regimen if the proportion of thrombotic events     will be no more than 3.5% with a power of 0.80 and a significance level of 0.05 (one-tail).      If the non-inferiority hypothesis will be rejected, the superiority hypothesis (12-months     regimen is superior to the 6-months-regimen) will be tested at a significance level of 0.05     (two-tails).      The maximal not clinically relevant difference for the non-inferiority hypothesis of 1.2 %     more thrombotic events has to be considered together with the lower expected number of     bleeding events in the 6-months regimen.      All the analysis will be done as intention-to-treat analysis.   "
236154|NCT00944346|"     -  Objective:             -  A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the               Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to               an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®,               Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects.        -  Study Design:             -  Randomized,single-dose,2-way crossover.   "
236155|NCT00944359|"     Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency     or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to     determine how best to integrate programs designed either to prevent zinc deficiency or to     treat diarrhea.      The overall objective of this project is to determine the most effective approach to prevent     zinc deficiency and treat diarrhea, such that a single approach could provide the maximal     beneficial impact on the health and nutritional status of young children and greatest     simplicity of implementation.   "
236163|NCT00944476|"     Magnetic resonance imaging (MRI) is presently the best study for assessing the size and     extent of the patient's sarcoma. Many sarcomas contain fat that can interfere with the     accuracy of sarcoma detection. The investigators have developed a new MRI method that can     suppress all the fat signals in the patient's tumor and this may improve the investigators'     ability to see the patient's sarcoma. The purpose of this study is to determine if the     investigators' new fat-free imaging methods provides them with images that are better than,     equal to, or worse than those images obtained by standard MRI methods. This study may help     the investigators develop a more accurate MRI examination.   "
236164|NCT00944489|"     The main goal of this study is to achieve a deeper knowledge of the adherence to     antihypertensive drug treatment and to evaluate the quality of life in this population. This     work has the following goals: primary objective is to assess the antihypertensive treatment     adherence in patients with essential hypertension on treatment for more than 6 months.      The secondary objectives include the assessment of quality of life, identification of     associated factors that affect adherence, knowledge of drugs used and comparison of levels of     adherence according to the different drug regimes      Two questionnaires shall be prepared The first questionnaire shall be anonymously completed     by the patient willing to participate. It is divided into two parts:        1. Treatment Adherence Scale (MMAS): this survey is made up of 4 questions having YES/No          answers and it grants 1 point per every NO answer, and zero points to every YES          answer.        2. The second part is the health-related quality of life Questionnaire (MINICHAL). The          questions refer to the last 7 days with 4 possible answer options: 0 (no, absolutely          not), 1 (yes, sometimes), 2 (yes, frequently) and 3 (yes, a lot). It is made up of 16          items, 10 correspond to the State of Mind dimension and 6 to the Body-related          Symptoms, also described as Physical symptoms.      The second questionnaire shall be completed by the intervening physician as regards patients     that attend medical visits, and who have answered the anonymous questionnaire.   "
236165|NCT00944502|"     To evaluate the efficacy and tolerability of Vitatonus Dexa compared with dexamethasone in     the signs and symptoms of neuralgia of various origins.      Clinical study, randomized prospective and random in nature, with a patients diagnosed with     neuralgia of diverse origin.      Patients will be include in sufficient quantity to achieve the minimum of 104 evaluable     patients.   "
236166|NCT00944515|"     The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing     recurrent acute sinusitis in children.   "
236167|NCT00944528|"     This study seeks to determine the maximum tolerated dose of a single-dose partial breast     radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be     performed within 3 weeks (+/- 1 week) of completing radiation.   "
236168|NCT00944541|"     This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV     infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6     months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL     during last 24 months).      The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment     period will be maintained for 12 months.   "
236169|NCT00944554|"     This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation     aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the     laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking     and will delay or prevent relapse compared to placebo.   "
236170|NCT00944567|"     A non-profit study designed with the aim of analysing the phenotype and molecular     characteristics (central review) and evaluating prospectively the role of PET-scans in the     management of primary mediastinal lymphoma treated with conventional approaches.   "
236171|NCT00948311|"     The purpose of this study is to develop and validate a survey instrument to be used by     persons with type 1 diabetes aged 12 and older to screen for an eating disorder.   "
236172|NCT00948324|"     The purpose of this study is to investigate and evaluate the effects of different     interventions (1.continuous subcutaneous insulin infusion,2.continuous subcutaneous insulin     infusion combined with rosiglitazone 3.continuous subcutaneous insulin infusion combined with     metformin,4.continuous subcutaneous insulin infusion combined with α- thioctic acid daily     injections,) on glycemic control, B-cell function and the remission rate in newly-diagnosed     type 2 diabetic patients.   "
236174|NCT00948350|"     This is a prospective, comparative, randomized, monocentric, clinical open study, to compare     two anesthesia techniques (translaryngeal injection vs. spray as you go) in patients with     cervical instability with regard to technical modalities and quality of fiberoptic awake     intubation.   "
236175|NCT00948363|"     The purpose of this study is to determine whether the intake of kiwi fruits will reduce     systolic and diastolic blood pressure compared to intake of apples. The investigators     hypothesize that the increased intake lutein or other components in the kiwi fruit will     enhance nitric oxide bioavailability and lead to vascular relaxation.   "
236176|NCT00948376|"     The aim of the project is to prospectively analyze at a clinical and molecular level a series     of 50 asphyxiating thoracic dysplasia (ATD) patients and 20 fetuses to further define the     natural history of the disorder and to contribute to the identification of its molecular     basis.   "
236177|NCT00948389|"     To determine whether dasatinib plus lomustine are effective for treatment of recurrent     glioblastoma   "
236190|NCT00948558|"     1. To compare the differences of citrate pharmacokinetics in healthy individuals and          critically ill patients as well as the influential factors.        2. To validate a pharmacokinetic model which has been established in a formal paper.        3. To create a safe and effective RCA-CRRT protocol.   "
236191|NCT00948571|"     Perioperative airway resistance and lung function are evaluated perioperatively in patients,     who undergo surgical procedures in different postures and with or without gas insufflation     into the peritoneal cavity.   "
236192|NCT00948584|"     The investigators designed the system in type 2 diabetic patients treated with long acting     insulin to produce an automatic adjustment of insulin dose based on real time glucose level     data and to provide to the patients the needed insulin dose by using a short message service     (SMS) and apply to the clinical practice.   "
236178|NCT00948402|"     Insulin-resistance plays an important role in polycystic ovary syndrome (PCOS)     physiopathology. The phosphoprotein enriched in the diabetes (PED/PEA-15), a 15 kDa protein     related to insulin sensitivity, is over-expressed in type 2 diabetic patients and in PCOS     women, independently of obesity. The effectiveness of oral contraceptives pills (OCP) or     metformin (MET) in PCOS management is still uncertain. Aim of this pilot clinical study was     to compare the effects of OCPs or MET on the expression of PED/PEA-15 in association with     insulin sensitivity in obese PCOS women. Outcome measures: PED/PEA-15, BMI, plasma glucose     and insulin, 1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI,     quantitative insulin sensitivity check index; ISI: whole-body insulin sensitivity index.     Study design: twenty obese PCOS women (age: 24.7±18 yr; BMI: 30±2.4 kg/m2) were randomized     according to insulin sensitivity to receive 30 µg ethinylestradiol plus 30 mg drospirenone 21     day/month or MET 1250 mg three times daily for 6 months. Results: At baseline, age and BMI     were not different in the two groups; PED/PEA-15 protein expression was higher in MET than in     OCP group (p=0.011), along with higher 1/HOMA-IR (p=0.004), and lower QUICKI and ISI (p=0.003     and p<0.001, respectively). After treatment, independently of body weight, only in MET group     PED/PEA-15 decreased (p=0.004), along with insulin and 1/HOMA-IR (p<0.001), and QUICKI and     ISI increased (p<0.001). Insulin sensitivity indexes improvement correlated significantly     with PED/PEA-15 protein expression, but not with BMI. Conclusions: PED/PEA-15 protein     over-expression in obese PCOS women with IR reduced after a six month treatment with MET,     while remained unchanged in the OCP group. The reduction was independent of body weight, and     correlated with insulin sensitivity indexes. This effect further supported MET as a more     effective therapy than OCPs for obese PCOS women with IR, also when fertility is not     required.   "
236179|NCT00948415|"     Obesity is a major health problem that has reached epidemic levels. Efforts are needed to     develop cost-effective public health approaches for weight loss and maintenance. One such     approach is to develop team-based programs that may motivate people to lose weight and/or     increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI).     The current trial is investigating whether adding both a behavioral intervention delivered     online PLUS automated feedback to self-monitoring would enhance the outcomes of SURI     participants.   "
236180|NCT00948428|"     At the end of the study, safety and efficacy outcome measures will be compared to determine     a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently     marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in     comparison to the Vehicle cream.   "
236181|NCT00948441|"     This study is a double-blind crossover design to compare prophylaxis with ethanol lock     therapy versus placebo lock therapy (heparin). The primary outcome measure will be the number     of catheter related blood stream infections (CRBSI) in each time period.   "
236182|NCT00948454|"     The current proposal, will elucidate the role of oxidant stress (OS) on arterial function as     measured by flow mediated vasodilation. In addition, the investigators will address the     hypothesis, that a pro-oxidant might have different degrees of effects on different     biological targets, by performing quantitative assessment of the effects of OS on lipids,     proteins and DNA.   "
236183|NCT00948467|"     The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and     maximum tolerated dose of TAK-733 in patients with advanced, nonhematologic tumors. The     expansion stage of the study will evaluate evidence of antitumor activity of TAK-733 in     patients with advanced metastatic melanoma.   "
236184|NCT00948480|"     This protocol was conducted as a single institution trial at Hoag Cancer Center, Hoag     Hospital, Newport Beach, California. It was a single-arm phase II trial in which patients     with metastatic melanoma received subcutaneous (s.c.) injections of irradiated autologous     tumor cells that had been established as short-term cell lines, in conjunction with their own     dendritic cells (DC) and granulocyte macrophage colony-stimulating factor [GM-CSF]. Eligible     patients had regionally recurrent and/or distant metastatic cancer.   "
236185|NCT00948493|"     The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with     serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory     alternative therapy available for treatment of diabetes, and who are not eligible to     participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL). This protocol is     intended as a substitute for the Single Patient IND mechanism to obtain Generex Oral-lyn™.   "
236186|NCT00948506|"     This is a two-arm, single center placebo-controlled double-blind proof of concept study which     will evaluate the safety and efficacy of topical cidofovir (both 1% and 3%)compared to     placebo for the prevention of hair growth.   "
236187|NCT00948519|"     Chronic rhinosinusitis (CRS) is common disorder which affects up to 13% of the US population.     CRS affects numerous Quality of Life (QOL) factors including smell, sleep and communication.     The common treatment for medically noncompliant CRS is Functional Endoscopic Sinus Surgery     (FESS).      As the disease course is generally idle, prolonged medical treatment guidelines are for     antibiotic treatment, prescribed accordingly following appropriately obtained nasal cultures,     lasting weeks with or without additional topical or oral steroid treatment. While FESS     success rate is a general notion, a failure rate of primary FESS is as high as 2-24%2, with a     Cochrane review even suggesting that FESS though a safe procedure is of no benefit more than     medical management.      With that in mind as we address the failed FESS, new bacteria emerge. The new bacteria in CRS     are Coagulase-negative staphylococci were the most common isolates (36%), followed by     Staphylococcus aureus (25%), Streptococcus viridans (8.3%), Corynebacterium (4.6%), and     anaerobes (6.4%).      Patients not relieved by primary FESS demonstrate a significant rise in Pseudomonas and MRSA     bacteria positive cultures. Moreover surgical success for patients with Staphylococcus aureus     and Pseudomonas aeruginosa positive cultures is usually reduced.      Bacterial killing, by usage of light-activated agents such as Indocyanine Green (ICG) with     exposure to the specific wavelength, eventually produces bacterial killing. Mechanisms     primarily involved are production of reactive oxygen species (i.e. singlet oxygen and free     radicals) which can then kill bacteria. ICG by itself does not have any bacterial killing     effect.      Low level laser therapy (LLLT) was shown to be effective as a bactericidal by single and     multiple wave exposures.      The study purpose is to treat CRS with an alternative to antibiotics, thus sparing volunteers     from prolonged antibiotics use and its possible side effects, not to mention the cost and     growth of resistant bacteria. We believe that by combining ICG with light or even by light     alone we can produce you a beneficial effect. Although this has been shown to kill bacteria     in lab or animal studies it is still investigational for humans. The study will have two     arms: ICG + laser and laser only arm. ICG will be applied locally in the nasal passage     (internally) followed by laser activation with a power setting of 6W. The laser will be     activated with a diffuser mode meaning light of a specific known wavelength will be delivered     evenly in the nasal cavity and not as a beam. Laser only treatment plan will be the same only     without ICG. Volunteers will be assigned to one of the groups randomly meaning you have a 50%     chance of enrolling to each treatment group. Volunteers will not know to which group. Weekly     visits with a total of three visits will follow. With each visit Volunteers will receive     additional treatment as the initial treatment was and a nasal culture will be taken.     Volunteers will have to fill a questionnaire with each visit.   "
236188|NCT00948532|"     This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus     in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two     levels. These subjects will present with degenerative conditions in the lumbar spine that are     amenable to surgical treatment and will be screened prior to study enrollment. Subjects will     receive Osteocel Plus during their XLIF operation. Subjects will be followed for 24-months     following surgery to determine the number of study subjects that are solidly fused at or     before 24 months postoperatively, and to determine the mean time to fusion. This data will be     compared to published and/or retrospective data for autograft, synthetic ceramics and Bone     Morphogenetic Protein (BMP).   "
236227|NCT00949039|"     Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis     perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).      Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.      The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated     pelvic perfusion.   "
237264|NCT00963534|"     In phase I: Establishing maximally tolerated dose of lenalidomide in combination with     bendamustine and rituximab.      In phase II: Evaluation of progression free survival with treatment with lenalidomide,     bendamustine and rituximab   "
236189|NCT00948545|"     In the proposed study, the investigators will explore three specific aims. First, the     investigators will examine cross-sectionally the association of obesity on sympathetic,     parasympathetic, and sympathetic/ parasympathetic nerve fiber balance. In addition, the     investigators will determine the relationship of the ANS and osteocalcin. Osteocalcin will be     measured before and after a mixed meal tolerance test.      In the second specific aim, the investigators will prospectively follow-up these individuals     (n=30) following bariatric surgery. The effect of weight loss on measures of the ANS and     osteocalcin will be examined 6 months following surgery with participants serving as their     own control, pre- and post-surgical intervention.      Thirdly, the investigators will address whether the effect of weight loss on the ANS and     osteocalcin differ between those who had a history of diabetes at baseline versus those with     no history of diabetes.   "
236193|NCT00948597|"     The U.S. National Health and Nutrition Examination Survey of 1994 indicated that 59% of     American men and 49% of women have body mass indexes (BMIs) over 25. Extreme obesity, defined     as a BMI of 40 or more, was found in 2% of the men and 4% of the women     [http://www.cdc.gov/nchs/nhanes.htm]. The newest survey in 2007 indicates an alarming     increase in BMI; 63% of Americans are overweight, with 26% now in the obese category. With     extreme obesity as high as 26-30% in adults, obesity percentages in children are also sharply     on the rise. These alarming numbers pose a major clinical problem in terms of the safe and     effective use of drugs in children.      Obesity may alter the disposition and/or clearance of drugs in the body as well as the     response, which should be considered when using anesthetics in these patients. Total     intravenous anesthesia (TIVA) with propofol is widely used in children, adolescents and     adults undergoing surgery, because of rapid onset of action, ease of titration and rapid     offset of action. While extensive research on optimal propofol dosing has been performed in     non-obese adults, including in critically ill mechanically ventilated adult patients by the     investigators' collaborators, there is no evidence on required dosages in morbidly obese     adult or pediatric patients of this highly lipophilic agent. As a consequence, serious     problems do arise due to under- and overdosing, increasing the risk of inadequate effects and     adverse events, respectively. Crucial additional information is needed on the     pharmacokinetics of drugs used in morbidly obese children to improve safety and efficacy.      This proposal will test a novel approach by identifying pharmacokinetic/pharmacodynamic     (PK/PD) factors that are associated with response to therapy and adverse events. If     successful, this study will provide proof of concept data for PK/PD model-based dosing     strategy that can be implemented into daily clinical care to allow tailoring of dose to     individual needs. Propofol is a versatile anesthetic agent which if dosed to individual needs     based on a patient's characteristics and specific PK/PD parameters, will allow individualized     dosing, thereby greatly reducing related toxicities. The prospective identification of     predictive factors in these morbidly obese high-risk patients represents a new approach to an     increasingly common clinical problem. The investigators expect that this study will generate     the PK/PD data necessary to continue with a well powered prospective clinical trial.   "
236194|NCT00948610|"     More than half of rheumatoid arthritis (RA) patients complain of sleep disturbance and this     cardinal complaint is associated with fatigue, pain, and depressed mood in patient with     chronic inflammatory disorder. Despite the frequency of this complain, there is limited     efforts to evaluate sleep or the abnormal increases in the expression of proinflamatory     cytokines play a key role in the progression of RA, we hypothesize that the cytokine network     is one physiological system that is associated with sleep disturbances in RA patients.     Proinflamatory cytokines signal the central nervous system and are associated with increased     symptoms of pain, fatigue, and depressed mood in rheumatic patients. Moreover, sleep loss is     coincident with alterations in sympathetic tone, which is thought to contribute to increases     of proinflammatory cytokine activity. The specific aims of the study are to examine the     contribution of cytokines on sleep by administering a TNF antagonist vs. placebo to probe the     action of proinflammatory cytokines on sleep in RA Patients. Examination of sleep and its     consequences for autonomic functioning and proinflamatory cytokine activity within the     framework of an observational and experimental research design will have implications for     understanding the psycho-biological mechanisms that link sleep and the clinical     manifestations of RA. Results from this study will guide the developments of interventions     that target disordered sleep with potential effects on disability in RA.   "
236195|NCT00948623|"     This randomized controlled trial will assess the effect of adding intensive physical activity     counseling to an outpatient pulmonary rehabilitation program. Counseling including real-time     feedback on daily activities from an activity monitor will be offered to improve     participation in physical activities in daily life during and after an outpatient pulmonary     rehabilitation program.   "
236196|NCT00948636|"     The study tests the hypothesis that related hematopoietic stem cell donors are at a higher     risk for acute medical and psychological toxicity associated with the donation process     compared to adult unrelated hematopoietic stem cell donors.      The study will also assess the hypothesis that young (<18 years) and older (>60 years)     related donors are at increased risk for toxicity associated with donation compared to     younger adult donors by describing the adverse events reported in these populations.      An ancillary study of the psychological impact of donation on health-related quality of life     (HRQoL) will enroll related donors and compare them to an age-matched normative cohort.   "
236197|NCT00948649|"     The goal of the proposed study is to validate an experimental paradigm to assess medication     effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence     and a programmed cigarette lapse.   "
236198|NCT00948662|"     This study will assess the safety and tolerability of ascending single oral doses of SAM-760     in healthy young adult and healthy elderly subjects. The secondary objectives are to provide     the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on     the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and     to evaluate the effects of concomitant administration of ketoconazole on the safety and the     concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult     subjects.   "
236341|NCT00950521|"     The objective of the study is to determine the efficacy of brain transplants of CD34+ stem     cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.   "
236200|NCT00948688|"     The durg vorinostat (Zolinza) is a type of drug called an histone deacetylase (HDAC)     inhibitor. It inhibits a group of enzymes called histone deacetylases. These enzymes help     cancer cells survive. By inhibiting these enzymes, vorinostat helps kill cancer cells. In     this research study vorinostat will be given along with radiation therapy and the drug 5-FU.     This is the first research study in which vorinostat will be given along with radiation     therapy and 5-FU. The purpose of this research study is to find the highest dose of     vorinostat that can be given safely along with radiation therapy and 5-FU. The investigators     will also begin to get information about whether vorinostat combined with radiation and 5-FU     may help to treat pancreatic cancer.   "
236201|NCT00948701|"     Physical activity programs, when offered in research settings, have been shown to improve     quality of life and reduce fatigue among breast cancer survivors. The investigators are     training Reach to Recovery volunteers at the American Cancer Society (New England Division)     to provide a 12-week telephone-based physical activity program (RTR Plus) for breast cancer     survivors. The comparison group of survivors will receive Reach to Recovery services (RTR).     Physical activity, fatigue and other outcomes will be examined among 108 breast cancer     survivors at the start of the program, at 12 weeks and 24 weeks. If the physical activity     program is found to be effective, there is a potential for dissemination among the 13,000     Reach to Recovery volunteers across the U.S.   "
236228|NCT00949052|"     RATIONALE: Identifying genes that increase a person's susceptibility to second cancers may     help the study of cancer treatment.      PURPOSE: This study is looking at genetic susceptibility and risk of second cancers in     patients who have undergone stem cell transplant for cancer.   "
236202|NCT00948714|"     Project Overview:      Poor hypertension control has dire consequences for the African-American population who     suffer greater death and disability from heart disease, stroke, and renal failure than     whites. To reduce these health disparities it is critical to promote of a healthy lifestyle     in regard to diet, exercise, adherence to medications, as well as other behaviors. However,     physicians usually fail to address lifestyle behaviors in the context of the harried patient     visit. Therefore, the investigators hypothesized that the investigators could reduce     cardiovascular risk by providing additional support to persons with poorly controlled     hypertension through phone calls from trained peer patients and visits to an office support     staff member.      Study Design:      A single-blind, randomized, controlled trial in 280 African-American primary care patients     aged 40-75 with poorly controlled hypertension (HTN). The intervention group receives a     practice-based team intervention that combines peer coach with office staff (i.e., medical     assistant or licensed practice nurse) visits to address lifestyle challenges. Both     intervention and control groups receive informational materials and healthy soul food recipes     from the American Heart Association. The 6 month intervention alternates monthly phone calls     from peer coaches about lifestyle behavioral changes with office-based visits with the     support staff member during which patients review and discuss low literacy slide shows about     healthy behaviors as well as examine their personal cardiovascular risk profile.   "
236203|NCT00948727|"     The purpose of this trial is to assess whether an adaptation of cyclosporine (CsA) dose     according to a longitudinal calcineurin (CN) activity monitoring would prevent the onset of     graft-versus-host disease (GVHD).   "
236204|NCT00948740|"     The investigators hypothesize that a 3 month course of vitamin D supplementation to treat     25(OH)D deficiency in stone formers with high levels of 24-hour urinary calcium will not     increase urinary calcium excretion by greater than 10%.   "
236205|NCT00948753|"     This study investigates the effectiveness and safety of Maraviroc (an oral medication given     twice daily given in addition to the standard GVHD prophylaxis) in preventing Graft versus     Host Disease (GVHD) in patients undergoing non-myeloablative allogeneic stem-cell     transplantation (SCT). Subjects will receive Maraviroc bid (in addition to standard GVHD     prophylaxis) beginning after the last dose of the chemotherapy conditioning regimen until day     30 after stem-cell infusion.   "
236206|NCT00948766|"     The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h     transdermally (15 cm^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h     transdermally (5 cm^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a     24-week study. The extension study obtained additional safety and efficacy data, as well as     provided the higher dose rivastigmine patch to all patients who completed the core study for     an additional 24 weeks.   "
236207|NCT00948779|"     The purpose of this study is to determine if a patient education in acute condition about the     intake of oral solution antibiotic in children under 6 year-old are effective to improve the     satisfaction about the therapeutic education, the knowledge about antibiotics among the     patients' families and thereby decrease the misuses of antibiotics.   "
236208|NCT00948792|"     To evaluate changes in platelet counts and hemodynamics between rapid and long platelet     infusion groups.   "
236209|NCT00948805|"     This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh)     agonist to prevent the rise of progesterone during controlled ovarian stimulation for in     vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on     the first day of menses.   "
236210|NCT00948818|"     The objective of this trial is to determine the efficacy and safety of linaclotide     administered to patients with irritable bowel syndrome with constipation (IBS-C).      The primary efficacy parameter is the percentage of patients in each treatment group that     meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC)     Responder.   "
236211|NCT00948831|"     This study is being conducted to determine the percentage of patients with solid spinal     fusions after being treated with Osteocel Plus in an ALIF procedure. Due to the unique     processing conditions, Osteocel Plus retains a high concentration of stem cells in     conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with     Osteocel Plus will be comparable to published data for autograft. The Osteocel product family     has already been used in approximately 15,000 cases worldwide.   "
236212|NCT00948844|"     The aim of this study is to develop an algorithm to automatically detect falls and near     falls, in the elderly and in Parkinson's Disease patients. Subjects will arrive at the     investigators' gait laboratory for assessment. A sub-group of the subjects, will receive a     monitoring device, to be worn at home for three days.   "
236213|NCT00948857|"     The experimental focus of this project is on the interaction of DHEA treatment on pregnancy     in women with open tubes, fertile male partners and evidence of premature ovarian failure.   "
236214|NCT00948870|"     The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription     Shugan decoction on irritable bowel syndrome（diarrhea type）.   "
236229|NCT00949065|"     The purpose of this study is to determine whether intravenous immunoglobulins are effective     in the treatment of complex-regional pain syndrome.   "
236230|NCT00949078|"     The purpose of this study is to determine if treatment with omalizumab (Xolair, anti-IgE) can     eliminate or reduce symptoms of peanut allergy.   "
236231|NCT00949091|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of multiple ascending-doses of TAK-875 in subjects with type 2 diabetes     mellitus.   "
236232|NCT00949104|"     RESEARCH HYPOTHESIS Orally administered sucrose 2 minutes prior to the procedure of OGT     insertion reduces pain associated with the procedure.      AIMS AND OBJECTIVES:      To study the effect of 24% oral sucrose on decreasing the painful response to orogastric tube     insertion .   "
236233|NCT00949117|"     RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss     caused by cancer or cancer treatment. It is not yet known whether cyproheptadine     hydrochloride is more effective with or without nutritional supplementation in improving     weight and quality of life of young patients with weight loss caused by cancer or cancer     treatment.      PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how     well it works when given together with or without nutritional supplementation in treating     young patients with weight loss caused by cancer or cancer treatment.   "
236215|NCT00948883|"     About 1500 solid organs transplants are performed each year in the Paris agglomeration.      Cancer risk in the transplanted is about three times higher than in a population of the same     age without any organ transplant. Thus cancer is an important problem for organ transplant.      These cancers can be related to many factors :        -  Post-transplant cancers are due in part to the non specific immunosuppression, which          leads to oncogenic viruses replication, and then produces virus inducted cancers (as          lymphoma due to EBV virus).        -  Post-transplant cancers can also be due to the carcinogenic factors of the          immunosuppressive drugs (as cyclosporine or tacrolimus, which can cause the appearance          of metastases). However, a new type of immunosuppressive drugs (mTOR inhibitors) appear          to have anti-cancer properties.        -  Post-transplant cancers which are not virus-inducted can be relied to genetic factors of          the transplanted patient and/or the transplant donor.      There are 4 axes in this study :        -  Axis 1 : Epidemiological, clinical and biological study of the incident cancers in          transplanted patients.        -  Axis 2 : Qualitative and quantitative immunological study of lymphocyte cells by the          transplanted patient (determine their characteristics when a cancer appears).        -  Axis 3 : Pathological and genetic study of the post-transplant cancer cells (see if the          cancer is caused by the donor or the recipient). Creation of a biobank.        -  Axis 4 : Pharmacogenetic study of the immunosuppressive drugs (determine the impact of          patient genetic variability on tolerance and efficiency of the immunosuppressive drugs).   "
236216|NCT00948896|"     Young African children living in high transmission areas suffer the greatest burden of     malaria. In most African countries, such as Uganda, the only current preventive measure     against malaria in high transmission settings is the use of insecticide treated bednets     (ITNs). Preliminary data show that even in the setting of ITN use, young children living in a     high transmission setting suffer almost 4 episodes of clinical malaria per year, highlighting     the need for new preventive strategies. Chemopreventive strategies offer a potential means of     reducing the burden of malaria among young children living in a high transmission setting.     This study will compare the efficacy and safety of 3 promising chemopreventive strategies     (monthly dihydroartemisinin-piperaquine, monthly sulfadoxine-pyrimethamine, daily     trimethoprim-sulfamethoxazole) with the current standard of no chemoprevention and will be     conducted in two distinct patient populations: 1) HIV-unexposed children (HIV-uninfected     children born to HIV-uninfected mothers) and 2) HIV-exposed children (HIV-uninfected children     born to HIV-infected mothers). The intervention will begin in HIV-unexposed children when     they reach 6 months of age, the time at which the incidence of malaria begins to increase,     and will be continued until the children reach 24 months of age, which prior data suggest is     when the incidence of malaria begins to decline due to the development of semi-immunity. In     addition, study participants will be followed for one additional year following     chemopreventive therapy to examine for rebound in the incidence of malaria following our     intervention. HIV-exposed children will begin the intervention when they have completed     breastfeeding and have been confirmed to remain HIV-uninfected. The intervention will     continue until study participants reach 24 months of age and then the study participants will     be followed for an additional year to examine for rebound in the incidence of malaria. It is     anticipated that the results of this study will provide valuable comparative data on the     effect of different chemopreventive strategies on malaria incidence in two distinct patient     populations at high risk for malaria. In addition it is anticipated the results of this study     will provide insight into the development of naturally acquired antimalarial immunity in the     setting of chemopreventive therapy that will differ in terms of the drug regimens, the age at     which the intervention is started, and the HIV status of the mothers.   "
236217|NCT00948909|"     This is a efficacy and safety study evaluating new treatment for subjects with mild to     moderate Alzheimer's Disease.   "
236218|NCT00948922|"     The purpose of this study is to evaluate the effectiveness of Bortezomib when added to     standard chemotherapy medicine(s) for treatment of Multiple Myeloma.   "
236219|NCT00948935|"     This study evaluates the combination chemotherapy with gemcitabine, irinotecan and     panitumumab in patients with advanced biliary cancer.   "
236220|NCT00948948|"     Mentor is undertaking a five-year prospective clinical study designed to collect safety data     associated with the implantation of its gel-filled mammary prostheses. This study is an     adjunct study, which will encompass clinical reviews of reconstructive cases in all     patients who meet clinical and regulatory criteria for breast reconstruction with gel-filled     mammary prostheses. This adjunct study will be accomplished under a limited clinical     protocol in which specific parameters will be required but with controls somewhat less     stringent than those normally required in Investigational Device Exemption (IDE) Trials.   "
236221|NCT00948961|"     The main purpose of this study is to examine the safety and tolerability of CDX-1401 when     given in combination with an immune stimulant (resiquimod) to patients with advanced cancers     that are known to express the NY-ESO-1 protein.   "
236222|NCT00948974|"     The purpose of this study is to compare the efficacy of two variants of cognitive behavioral     therapy (CBT) (cognitive therapy (CT) and acceptance and commitment therapy (ACT)), for the     treatment of generalized social anxiety disorder.   "
236223|NCT00948987|"     The purpose of this research is to study why some people do not respond to the benefits of     aspirin therapy. The benefit of aspirin is cardioprotection, or decreasing the risk of heart     attack and/or stroke. Aspirin works by disabling the platelets, part of the blood cells used     in clotting, from sticking together and forming blood clots, thus protecting the heart. It     has been observed that failure to respond to aspirin therapy occurs in about 10% of the     general population and that despite taking aspirin everyday, this group of non- responders is     not getting protection for their heart. The investigators would like to determine why and how     this happens.   "
236224|NCT00949000|"     The objective of the study is to collect information on the naturally occurring variations in     ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel     Implantable Cardioverter Defibrillators (ICD).   "
236225|NCT00949013|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how patients enrolled on clinical trial SWOG-9313     will respond to doxorubicin and cyclophosphamide.      PURPOSE: This laboratory study is looking at tumor tissue samples from women with early-stage     breast cancer enrolled on clinical trial SWOG-9313.   "
236226|NCT00949026|"     The primary purpose of this study is to determine if it is effective to take samples of fluid     from the patient's brain tumor with a microdialysis catheter for Torisel measurement. The     investigators are also doing it to learn if it is safe to do so. The investigators will use     these samples to measure how much Torisel reaches the patient's brain tumor. The use of the     microdialysis catheter to collect brain fluid is an FDA approved method. This catheter is     already being used in patients who have sustained severe brain trauma from head injuries. The     catheter itself is smaller in size than the standard needle that will be used to take the     patient's biopsy. To obtain additional information Torisel will also be measured at the same     time in the patient's cerebral spinal fluid by taking it from a catheter placed in the     patient's cerebral spinal fluid producing spaces in their brain and in their blood from a     catheter in one of their vessels.   "
236236|NCT00949156|"     With the preliminary anatomical and histological study, the membranous structures of the     sellar region was considered to be closely related with the growth pattern of     Craniopharyngiomas(CP). By combined considering of the tumor-membrane relationship, this     project was trying to classify the CP through retrospectively summarizing the pre- and     postoperative imaging (MRI and CT), the intrasurgical findings, and the endocrine data of 198     CPs with primary surgery in our hospital (since 1997 until now). As a result, a distinct and     systematic CP classification was proposed. The possible originate site, surgical skills and     postoperative treatment of all the subtype tumors were discussed and analyzed to provide a     normalized surgical treatment for this kind of tumor. Then in the prospective cohort, the     anticipated 100 CP patients will accept the normalized surgical treatment. And by the long     term follow up, the postsurgical quantity of life (QOL) of patients was evaluated with aspect     in cognition, circadian rhythm, endocrine, Water-Electrolyte and body weight, et al. By     comparing with the long-term results of the retrospective cohort, the totally follow up data     was statistically analyzed to assess the rationality of this standard treatment of CP.   "
236237|NCT00949169|"     The aim of this study was to investigate whether carotid IMT can predict the presence of more     advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by     MDCT and whether MDCT could be useful next step for more aggressive treatment modality in     Korean type 2 diabetic patients.   "
236238|NCT00949182|"     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as doxorubicin hydrochloride and mitomycin C, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and     blocking blood flow to the tumor. Giving sorafenib tosylate before and after     chemoembolization may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib     tosylate before and after hepatic arterial chemoembolization with doxorubicin hydrochloride     and mitomycin C works in treating patients with localized liver cancer that cannot be removed     by surgery.   "
236239|NCT00949195|"     Background:      The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in     patients with COPD is unpredictable from lung function data. The non-invasive assessment of     pulmonary hemodynamics during exercise and flow-mediated vasodilatation measurement may give     useful data in the rehabilitation of COPD patients.      Methods:      Patients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine     echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange     detection. Serum hsCRP level is also determined in COPD patients. Endothel dysfunction is     detected by flow mediated vasodilation measurement after arm strangulation with Doppler     ultrasonography.      Primary endpoint:      The degree of pulmonary artery systolic pressure change during exercise?      Secondary endpoint:        1. The degree of right ventricular function change during exercise?        2. Is endothel dysfunction manifested with pulmonary artery pressure rise?        3. What is the correlation between the systemic inflammatory marker hsCRP and the degree of          pulmonary artery pressure rise?   "
236240|NCT00949208|"     The purpose of this study is to support the development of Given® Diagnostic System     applications.   "
236241|NCT00949221|"     Glycemic control in children and adolescent with type 1 diabetes remains inadequate, exposing     them to the risk of vascular complications in adulthood.      One of the limiting factors is the daily number of self measurements of blood glucose     required to optimize intensive insulin therapy.      Real Time Continuous Glucose Monitoring augmented by alarms (RT CGM) is a recent innovation.     A randomized clinical study has shown its efficacy at short term (3 months). However, optimal     clinical use of these devices requires rigorous assessment of their effectiveness on glycemic     control, tolerance and acceptability in medium and long term.      Primary objective: To assess the long-term effectiveness of two strategies of use of RT CGM     (continuous or discontinuous) on glycemic control compared to conventional blood glucose     self-monitoring (SMBG).      Population: Children and adolescents with type 1 diabetes with inadequate glycemic control     despite intensive insulin therapy.   "
237265|NCT00963547|"     This study will find the maximum tolerated dose of MK2206 in combination with both     trastuzumab and trastuzumab/lapatinib in patients with HER2+ breast cancer and other solid     tumors.   "
236242|NCT00949234|"     The purpose of this program is to evaluate an effort to provide a comprehensive package of     HIV prevention services of which post-exposure prophylaxis (medicines that may help prevent     HIV infection after an exposure) can be a part. It will also include risk reduction     information and testing for other sexually transmitted infections.   "
236243|NCT00949247|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as trastuzumab and bevacizumab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy     together with monoclonal antibody therapy may kill more tumor cells.      PURPOSE: This clinical trial is studying how well giving docetaxel and carboplatin together     with trastuzumab and bevacizumab works in treating patients with stage I, stage II, or stage     III breast cancer and bone marrow micrometastases.   "
236244|NCT00949260|"     The purpose of this study is to determine whether a noninvasive method of measuring certain     aspects of blood circulation (e.g., blood pressure, cardiac output) is an accurate and     reliable method to detect changes in pregnant patients. Specifically,the investigators are     interested in patients diagnosed with high blood pressure during their pregnancy, as compared     with normal pregnant patients. A noninvasive, accurate method of taking these measurements in     pregnant patients is not currently available.   "
236245|NCT00949273|"     The purpose of this study is to determine whether cylindrical abdominoperineal resection is     effective in the treatment of advanced very low rectal cancer   "
236515|NCT00954005|"     The purpose of the phase I part is to determine the tolerability, the initial safety profile     and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent     lymphoma. In the phase II part the investigators want to estimate the activity of gemcitabine     and oxaliplatin in combination with rituximab for patients with relapsed/refractory indolent     lymphoma.   "
236246|NCT00949286|"     The study is designed to determine the long term, post trial effects of the two interventions     studied in ADVANCE (routine blood pressure lowering with perindopril-indapamide as compared     with placebo and intensive gliclazide-MR based glucose control as compared to standard     guideline based glucose control) in individuals with type 2 diabetes at high risk of     cardiovascular events. The long term, post randomization effects of the two study     interventions will be investigated separately as they were for the main trial. This study     will clarify and quantify the long-term, post trial (often referred to as legacy) effects of     these two interventions in a broader population of patients with type 2 diabetes from high     and low to middle income countries, and in the setting of comprehensive cardiovascular risk     factor treatment. With the ADVANCE trial infrastructure and surveillance system already in     place, the implementation of extended follow-up will be feasible. The conclusions of this     follow up study will have profound clinical implications for the care of patients with type 2     diabetes around the world.   "
236247|NCT00949299|"     Recent reports showed that the opioid buprenorphine is a very potent sodium channel blocker.     Buprenorphine not only exerts a strong antinociception, but also a long lasting     antihyperalgesic effect. This antihyperalgesic effect is not observed for other clinically     employed opioids but is common for local anaesthetics.      The principal aim of the study is to compare the speed of onset and the time of recovery of     motor blockage achieved by lidocaine and buprenorphine, respectively. The investigators     hypothesize that the blocking capacity of buprenorphine is equal to the one of lidocaine.   "
236248|NCT00949312|"     RATIONALE: Diagnostic procedures that look for micrometastases in lymph nodes removed during     surgery for colon cancer may help doctors learn the extent of disease.      PURPOSE: This phase I trial is studying lymph nodes in patients with stage II colon cancer.   "
236249|NCT00949325|"     The purpose of this study is to identify a safe dosing regimen for the combination of Torisel     and liposomal doxorubicin in patients with recurrent sarcoma. A secondary purpose of the     study is to determine how effective this combination is for the treatment of recurrent     sarcoma.   "
236250|NCT00949338|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue. Having a full     bladder may improve the effectiveness of radiation therapy to the bladder. It is not yet     known which set of bladder-filling instructions is more effective in helping patients keep     their bladder full during radiation therapy.      PURPOSE: This randomized clinical trial is comparing two sets of bladder-filling instructions     in treating patients with prostate cancer undergoing radiation therapy.   "
236251|NCT00949351|"     Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin     converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown     renoprotection whether it was used alone or in combination. Aliskiren is a direct renin     inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to     date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic     nephropathy patients remains to elucidate.   "
236252|NCT00949364|"     This is a phase II, multi-center study of pomalidomide in adult patients with PMF, SMF, and     unclassifiable MPN showing at least grade 1 bone marrow fibrosis and requiring therapy. All     patients will receive per oral pomalidomide on a daily basis.      First cohort (Before Amendment No. 1 ID 1-41):      Treatment starts with a phase of pomalidomide therapy with 2 mg per day. Individual dose     reduction as outlined in the safety section is allowed. If no response was achieved (no     complete remission (CR), partial response (PR), clinical improvement (CI) and no progressive     disease according to the IWG-MRT criteria) after 3 months, prednisolone is added in a     starting dose of 30 mg per day. In the absence of progressive disease, at least 6 months of     treatment with pomalidomide is intended. In patients without disease progression after 6     months and those with response to treatment are intended to receive pomalidomide for at least     12 months. Additional antiproliferative treatment with hydroxyurea for leukocytosis (>20 x     109/l) and/or thrombocytosis (>750 x 109/l) and/or symptomatic splenomegaly in a starting     dose of 2g/day with individual dose adjustment is allowed.      Second cohort (After Amendment No. 1 ID > 41):      To evaluate the relative impact of prednisolone to the objective response rate, a     randomization has been integrated into the study concept. The addition of prednisolone is     up-front randomized for the start of prednisolone either after 3 or 6 cycles of treatment     with pomalidomide as single agent if no response occurred during this period. This results in     the following treatment arms:      Treatment Arm A) Pomalidomide 0.5 mg per day + additional prednisolone at start of cycle 4     (day 85), in case no response was achieved until end of cycle 3.      Treatment Arm B) Pomalidomide 0.5 mg per day + additional prednisolone at start of cycle 7     (day 169), if no response was achieved until end of cycle 6.      Treatment for all patients starts with pomalidomide as single agent at a dose of 0.5mg per     day. The addition of prednisolone will be initiated as randomized either at start of cycle 4     or start of cycle 7 (starting dose 30 mg per day). In the absence of progressive disease, at     least 12 cycles of treatment with pomalidomide are intended.      Additional antiproliferative treatment with hydroxyurea for leukocytosis (>20 x 109/l) and/or     thrombocytosis (>750 x 109/l) and/or symptomatic splenomegaly in a starting dose of 2g/day     with individual dose adjustment is allowed.   "
236253|NCT00949377|"     The investigators want to prove that people WITHOUT advanced cancer who are taking opioid     medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since     the FDA has only approved MNTX for advanced cancer patients, the investigators' research is     investigating how MNTX can work for NON-cancer patients. This research is being conducted to     prove that MNTX can work for non-cancer patients with opioid related constipation.   "
236254|NCT00949390|"     Primary Objective:      · The primary objective is to estimate the prevalence of use of complementary and alternative     medicine (CAM) in patients with advanced malignancies who are seen in the Phase I clinic at     MD Anderson Cancer Center (MDACC).      Secondary Objective:      · Examine the association between prevalence of CAM use and demographic and socioeconomic     characteristics (age, gender, race, income, and education level), participation in a phase I     clinical trial, disease characteristics (diagnosis), patients' perceptions about their     prognosis, physicians' information and permission for patients' CAM use, decision-making, and     types of CAM used by patients.   "
236255|NCT00949403|"     The purpose of this study is to evaluate how the liver receives and uses fats for energy.     This will help the investigators further understand the physical and chemical processes     responsible for Non-Alcoholic Fatty Liver Disease (NAFLD) in overweight females with or     without NAFLD who are scheduled to undergo gastric bypass surgery.   "
236256|NCT00949416|"     Objective: Recruit 3 cohorts with 1000-1200 subjects each: people with normal glucose     metabolism, impaired glucose regulation (IGR), and with Type 2 diabetes. To study the risk     factors in development of type 2 diabetes.   "
236257|NCT00949429|"     The purpose of this study is to determine the incidence and risk factors of moderate to     severe pain after cardiac surgery, and compare the preoperative pain expectation and     postoperative pain experience in the same patient.   "
236513|NCT00953979|"     This is a prospective randomized controlled study to evaluated the efficacy and safety of     kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major     outcome index is proportion of patients achieving ASAS20 response at week12, and minor     outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events     at any time were recorded to evaluate the safety.   "
236258|NCT00949442|"     Primary Objective:      To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin     Hagedornon) the change in HbA1c from baseline to the end of the treatment period.      Secondary Objective:      To compare between treatment groups:        -  Plasma glucose (fasting, nocturnal) over time,        -  Changes from baseline in HbA1c over time,        -  Percentage of patients who reach the target of HbA1c <7 and <6.5,        -  Use of prandial insulin as rescue medication at month 6,        -  Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and          severe),        -  Daily dose of insulin,        -  Change in body weight from baseline,        -  Evolution of 8-point plasma-glucose (PG) profiles,        -  Overall safety,        -  Patient reported outcomes (treatment satisfaction).   "
236259|NCT00949455|"     RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. It is not yet known whether lapatinib ditosylate is more     effective than a placebo in killing tumor cells.      PURPOSE: This randomized phase II/III trial is studying how well lapatinib ditosylate works     compared to a placebo in treating patients with stage IV bladder cancer.   "
236260|NCT00949468|"     The purpose of this study is to identify the predisposing factors, epidemiological features     and clinical and microbiological diagnosis of infectious keratitis in two public referral     centers of ophthalmology in a countryside city of Brazil.   "
236261|NCT00949481|"     The rationale for the study stems from the goal of reducing the very high unmet need for     family planning among women in their first year postpartum. It is understood that the reason     this need is so high in general is because postpartum women do not always demand family     planning services, and family planning providers do not always supply services to     postpartum (amenorrheic) women who do demand them. To address these supply and demand     problems, corresponding supply and demand solutions will be tested.        1. Demand Generating Strategy—Integrate into Immunization Services Following birth, return          to fertility among postpartum women is dependent on many factors. These include time          since last birth, breastfeeding intensity, and menstrual status. However, when and how          fertility returns is often misunderstood by women. For instance, many women think that          they can not get pregnant before their menses return, or that as long as they are          breastfeeding they are protected from pregnancy. Educating women about their return to          fertility following giving birth, and reminding women about the importance of birth          spacing for their health and the health of their children is the focus of the          demand-generating strategy.           To reach postpartum women with these messages a demand generating activity at          immunization clinics will be conducted, as immunization services are well attended.          Based on the recommended immunization schedules for infants, women will make several          visits to these clinics throughout the course of their first year postpartum, which          provides an ideal opportunity to hit them with family planning messages more than          once.           To aid providers of immunization services in their delivery of family planning messages,          a simple job aid was developed. The job aid takes providers through a series of 3          questions that will allow the provider to determine a mother's immediate risk for          pregnancy (based on LAM criteria). If a woman is currently at risk for pregnancy, it          prompts the provider to give a healthy timing and spacing message and to make a referral          to the family planning clinic. If a woman is not currently at risk for pregnancy, the          job aid helps the provider instruct the mother about when her risk for pregnancy will          change, and therefore when she will need to seek family planning services to achieve          proper birth spacing (should this be desirable to the mother).           Also, in the family planning (FP) clinics that are located in the same facility as the          immunization clinic, providers will be given the pregnancy checklist. This job-aid has          already been researched (refer to citations). The purpose of providing it is to make          sure that when women are referred to FP clinics by immunization providers, FP providers          will supply them with a method. As a consequence, it hoped that by the time women are          9-12 months postpartum, there will be an increase in uptake of non-condom family          planning methods.        2. Supply Solution—Diversify Tools Available to Rule-Out Pregnancy The supply strategy          focuses on giving providers the tools to give contraceptive methods to women who are          amenorrheic. As recommended by the WHO, it is standard practice for FP providers to rule          out the possibility of pregnancy before providing many types of methods to their          clients. The presence of menses is often used to make this determination. However,          return of menses can be delayed for many months in the postpartum period, limiting a          provider's ability to supply postpartum women with contraceptive methods. To overcome          this challenge, the Pregnancy Checklist was developed. It is a job-aid designed to rule          out pregnancy based on client responses to questions concerning her recent sexual and          reproductive history. Urine pregnancy testing is another viable option for ruling out          pregnancy in non-menstruating FP clients, especially in situations where providers feel          they cannot trust women to answer questions honestly. Thus, family planning clinics will          be provided with free pregnancy test strips, and the change in same day uptake of FP          methods will be measured.      Hypotheses        1. Providing family planning messages to women attending immunization clinics with their          child will cause them to seek family planning services in a greater proportion at 9-12          postpartum.        2. The availability of free pregnancy testing will increase same day method provision for          new and restarting family planning clients.   "
236262|NCT00949494|"     Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative used to treat knee     osteoarthritis (OA). Animal studies have shown that Synvisc can have favorable effects on     cartilage when injected into joints. This study attempts to evaluate the effects of Synvisc     when injected into knees of patients with knee OA by means of a specialized MRI technology     (dGEMRIC).   "
236263|NCT00949507|"     Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing     MRI in general anesthesia.   "
236264|NCT00949520|"     The goal of this study is to evaluate the ability of MDCT under stress to assess myocardial     ischemia. There is some preliminary data in the literature showing the ability of MDCT under     stress to bring relevant information about myocardial ischemia. Stress MDCT will have several     advantages over single photon emission computed tomography (SPECT) imaging namely: shorter     acquisition time, lower irradiation dose, lower cost. The feasibility of such experiment is     still debated and need to be address in a clinical study.   "
236265|NCT00949533|"     This open-label randomized 2 arm study will determine the emergence of viral resistance in     participants with seasonal influenza A infection treated with oseltamivir. Eligible     participants less than or equal to (</=) 5 years of age will be randomized to receive     oseltamivir at either standard dose (30-75 milligrams [mg] orally twice daily [bid]) or     double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (>) 100.   "
236266|NCT00949546|"     Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality     of life and allow healing of HS.   "
236267|NCT00949559|"     This study is being done to:        -  Test the safety of EP-100 and see what effect (good and bad) it has on the patient and          their cancer;        -  Find the highest dose of EP-100 that can be given without causing bad side effects;        -  Examine how much EP-100 is in the blood at certain times after it is given and how          quickly the body gets rid of it;        -  Observe whether there is any effect of EP-100 on the size and activity of cancer in the          patient's body.   "
236268|NCT00949572|"     This study is a preliminary investigation of immune responses, in the blood and in cervical &     vaginal secretions, to proteins (antigens) taken up across the undersurface of the tongue.   "
236269|NCT00949585|"     Chronic kidney disease is associated with high blood pressure, heart disease, and strokes.     Potassium lowers blood pressure and may help prevent heart disease and strokes in the general     population, but has not been well-studied in people with kidney disease. This study will look     at the benefits and safety of two levels of potassium intake in patients with kidney disease.     We expect that a higher level of potassium intake safely lowers blood pressure compared to a     lower level of potassium intake. We hope that this and other research projects will help us     to learn more so that guidelines can be created for potassium intake in patients with chronic     kidney disease   "
236270|NCT00949598|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by blocking the uptake of estrogen. Tamoxifen citrate may     fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known     whether letrozole or tamoxifen citrate is more effective when given before surgery in     treating older women with breast cancer.      PURPOSE: This randomized phase III trial is studying letrozole to see how well it works     compared with tamoxifen citrate in treating older postmenopausal women undergoing surgery for     breast cancer.   "
236271|NCT00949611|"     Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk.     Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis     treatment by providing an absolute fracture risk. FRAX combined with a decision aid may     promote a shared decision making approach with patients, allowing the clinician and patient     to weigh potential fracture risk (without treatment), versus risk reduction with medication     (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:        -  FRAX        -  FRAX + decision aid        -  Usual care (no decision aid and no FRAX given to clinician)   "
236272|NCT00949624|"     A5301005 is a phase 1 study in patients with solid tumors which is testing the safety and     tolerability of adding targeted agents to a standard chemotherapy. CP-868,596 is a     platelet-derived growth factor receptor inhibitor (PDGFR) and AG-13736 is a vascular     endothelial growth factor receptor inhibitor (VEGFR). This study will test the use of     docetaxel (the standard chemotherapy) with either CP-868,596 or the combination of CP-868,596     and AG-13736.   "
236273|NCT00949637|"     The purpose of the study was to evaluate the effectiveness of an intervention designed to     prevent obesity by improving the environmental characteristics of Girl Scouts troop meetings.   "
236274|NCT00949650|"     This randomised, open label phase III trial will be performed in patients with adenocarcinoma     of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation.     The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A,     with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of     patients.   "
236275|NCT00949663|"     An intestinal hormone called Glucose-dependent Insulinotropic Polypeptide (GIP) is released     into the blood immediately after ingestion of a meal and plays an important role in     regulating blood sugar levels. However, GIP is not active in persons with type 2 diabetes     mellitus (T2DM) which is also known as adult onset or non-insulin-dependent diabetes. This     study is being conducted to determine whether a hormone called xenin-25 can restore the     activity of GIP in persons with T2DM.   "
236276|NCT00949676|"     The purpose of this study is to determine whether heart rate variability-like parameters are     related to changes in the disease status of a subject that suffers from a disease that     decreases the pumping function of the heart.   "
236277|NCT00949689|"     This study will develop and test a youth cognitive behavioral insomnia intervention to be     employed as an adjunct to depression-focused cognitive behavioral treatments. The primary     goal of the study is to improve the treatment and prevention of youth depression beyond that     achieved with depression-focused pharmacotherapy and psychotherapies. The investigators'     ultimate aim in developing this intervention is to enable a series of future outcome trials     focused on improving unipolar depression outcomes in youth with comorbid insomnia, by     addressing sleep dysfunction. The study will be recruiting from Kaiser Health Plan members in     the Portland,Oregon metropolitan area and participants from the Bay Area region of     California.   "
236278|NCT00949702|"     This open-label single arm study will assess the efficacy, safety and tolerability of     Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive     oral Vemurafenib [RG7204; PLEXXIKON: PLX4032] at a dose of 960 mg b.i.d. continuously until     disease progression or withdrawal from study and will be assessed at regular intervals for     tumour response and tolerability. Target sample size is <100 patients.   "
236279|NCT00949715|"     The purpose of the Optimize RV Follow-Up study is to determine the long-term effect of     selective site pacing. Selective site pacing refers to which area of the right ventricle the     lead is placed. The goal of selective site pacing is to improve how the heart contracts when     paced.   "
236280|NCT00949728|"     To evaluate the recurrence and postoperative complications rates after conjunctival autograft     surgery using fibrin adhesive for primary pterygium   "
236281|NCT00949741|"     The purpose of this study is to define if flow cytometry has more sensitivity for detecting     neoplastic cells in cerebrospinal fluid versus conventional cytology.   "
236282|NCT00949754|"     The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation     of osteoarthritis of the knee.   "
236283|NCT00949767|"     The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics     and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.   "
236284|NCT00949780|"     Chloral Hydrate (CH) is a well known drug for sedative and hypnotic purposes used in     pediatric and dental procedures owing to the low depressive effect it has over respiratory     and cardiac systems. Despite that, the literature reports cases of heart arrhythmia and     sudden death in children, especially when using high doses, probably due to accumulation of     serum trichloroethanol, an intermediate metabolite resulting from the liver metabolism of the     drug. A possible carcinogenic action observed in guinea pigs has also been reported, even     though it has not been confirmed in human beings.      Among the least severe complications there are paradoxical agitation, nausea, vomiting and     excessive sleepiness.      CH is the drug of choice to sedate children undergoing Auditory Brainstem Response test     (ABR), in which any movement or muscle contraction may generate artifacts that interfere in     the analysis.      Profound sleep that lasts on average one hour is rapidly induced depending on the used dose,     causing no residual sleepiness after this period; however, there is consensus in the     literature about the best dose, which may range from 40 to 100 mg/kg.      Objective:      To assess the efficacy of CH as a sedative agent in performing ABR in children and to     systematize its use.   "
236285|NCT00949793|"     The purpose of the study is to test the feasibility of obtaining interpretable in vivo     endomicroscopy images which can be compared with traditional histopathology.      Hypothesis: That a rigid confocal endomicroscope can be used during neurosurgery to provide     in vivo histology that enables differentiation of tumour tissue from normal adjacent brain     tissue.   "
236342|NCT00950534|"     The primary objective is to demonstrate the improvement in glycosylated haemoglobin (HbA1c)     levels after general practitioner (GP) initiation and management of type 2 diabetes mellitus     (T2DM) with insulin glargine compared with their usual clinical practice.      The secondary objective is to demonstrate the importance of GP initiation of insulin glargine     for the treatment of T2DM.   "
237266|NCT00963560|"     The purpose of this study is to prospectively evaluate postoperative visual and refractive     parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting     Intraocular Lenses (IOLs).   "
236286|NCT00949806|"     Restless Legs Syndrome (RLS) is a common sensori-motor disorder that causes sensory     discomfort and motor restlessness, most often in the legs, which improves with movement.     Although medications are available to treat the disorder, many people either experience side     effects that prevent them from continuing on the medication or do not sufficiently respond to     current RLS medications. Recently, botulinum toxin type A (BNT) has been reported to relief     RLS in patients with severe symptoms but this was not confirmed by other anecdotal reports.     The investigators propose to test the efficacy of BNT on RLS symptoms by designing a more     controlled study. Ultimately, this may lead to extend the therapeutic arsenal of this     disorder.   "
236287|NCT00949819|"     Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with     low-risk, localized lesions, with curative treatment of those whose tumors show substantial     progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative     treatment of men with progressive prostate cancer.   "
236288|NCT00949832|"     The purpose of this study is:        1. To compare the response of rickets to calcium with and without vitamin D.        2. To assess whether vitamin D increases calcium absorption in calcium deficiency rickets.        3. To compare the response of children with and without rickets to orally administered          vitamin D3 and vitamin D2        4. To identify mutations that influence calcium and vitamin D metabolism among families of          children with rickets in Nigeria and Bangladesh.        5. To assess the functional status of the 25-hydroxylase enzyme in families possessing a          25-hydroxylase mutation.   "
236289|NCT00949845|"     Recent research has demonstrated a relationship between depression and immune system     activity, specifically proinflammatory cytokine activity. Although experimentally-induced     immune activation leads to increases in depressed mood, the neural correlates associated with     these changes have remained largely unexplored. Based on relationships between cytokine     activity, depression, and heightened physical and social pain sensitivity, I propose to     investigate the effect of proinflammatory cytokine activation on the neural correlates of     socially painful experience that may contribute to depression. Our previous work has shown     that the dorsal anterior cingulate cortex (dACC), typically associated with physical pain     distress, also plays a role in the distressing feelings associated with social rejection or     social loss. Moreover, recent pilot data has revealed that individuals with elevated levels     of baseline proinflammatory cytokines report feeling more distressed and show more dACC     activity during social rejection. To investigate the causal role that cytokines may play in     the heightened social pain sensitivity that can contribute to depression, participants will     be randomly assigned to receive either endotoxin (which increases proinflammatory cytokine     activity) or placebo. Subsequently, participants will complete a neuroimaging study in which     they will be rejected during an online ball-tossing game. We hypothesize that individuals     exposed to endotoxin will report more social distress and depression following rejection and     will show more dACC reactivity during rejection. The proposed study is the first to     investigate the effect of systemic inflammation on neural reactivity related to social and     affective processes that may increase the risk of depression.   "
236290|NCT00949858|"     The purpose of this study is to develop statistical and informatics tools for analyzing and     visualizing Actical™ (actigraphy) data linked to fatigue in Sleep Medicine Center patients.   "
236291|NCT00949871|"     RATIONALE: A study that evaluates successful Los Angeles-based, peer-led African American     breast cancer survivor support groups may help in developing a guide on how to organize and     maintain breast cancer support groups.      PURPOSE: This clinical trial is studying support groups for African-American breast cancer     survivors.   "
236292|NCT00949884|"     This study will evaluate the efficacy and safety of the FDA approved blood pressure     medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.   "
236293|NCT00949897|"     The purpose of this study is to compare the clinical and radiographic outcomes of a     randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a     lateral column lengthening using an allograft bone wedge versus a titanium porous metal     implant (Biofoam, Wright Medical).      Null hypothesis: At six months postoperatively, there is no difference in the degree of     correction as measured by the talonavicular coverage angle between patients randomized to     allograft and Biofoam.      Alternative hypothesis: At six months postoperatively, the degree of correction as measured     by the talonavicular coverage angle will be less in patients randomized to allograft than the     degree of correction in patients randomized to Biofoam.   "
236294|NCT00949910|"     This study will provide treatment with erlotinib to participants with advanced NSCLC who have     received at least one course of standard chemotherapy or radiation therapy, or who are not     medically suitable for either. Efficacy and safety will be monitored throughout the study.   "
236295|NCT00949923|"     Prognostic factors for breast cancer beyond stage at diagnosis and tumor characteristics have     not been well studied. Of special interest are lifestyle factors that can be modified by     women after diagnosis to increase disease-free survival. Green tea is rich in polyphenols     consisting primarily of epicatechins, epigallocatechin, epicatechin gallate, and     epigallocatechin gallate (EGCG). The investigators hypothesize that there will be a reduction     in proliferation and/or an increase in apoptosis in association with short-term EGCG     treatment.   "
236296|NCT00949936|"     The purpose of this European Union (EU) study to evaluate the safety and performance of the     CAdiscTM-L Lumbar Spinal Disc Replacement Device in the surgical replacement of the lumbar     intervertebral discs (L3 to S1) for patients requiring surgical intervention for total lumbar     disc replacement for the treatment of debilitating, chronic low back pain.   "
236297|NCT00949949|"     This randomized phase I trial is studying the side effects and best dose of everolimus,     gemcitabine hydrochloride, and cisplatin in treating patients with unresectable solid tumors     refractory to standard therapy. Drugs used in chemotherapy, such as everolimus, gemcitabine     hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) may kill more tumor cells.   "
236398|NCT00952419|"     The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic     vaccine in toddlers and children.      Primary Objectives:        -  To describe the immunogenicity of the candidate vaccines after each injection.        -  To describe the safety of the candidate vaccines after each injection.   "
236298|NCT00949962|"     RATIONALE: Conformal radiation therapy uses a 3-dimensional (3-D) image of the tumor to help     focus thin beams of radiation directly on the tumor. Giving conformal external-beam radiation     therapy in higher doses over a shorter period of time may kill more tumor cells and have     fewer side effects. Androgens can cause the growth of prostate cancer cells. Hormone therapy,     such as leuprolide acetate, may lessen the amount of androgens made by the body. It is not     yet known whether radiation therapy is more effective when given together with or without     hormone therapy in treating patients with prostate cancer who have undergone surgery.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works compared with radiation therapy given together with hormone therapy in treating     patients who have undergone surgery for stage I, stage II, or stage III prostate cancer.   "
236299|NCT00949975|"     The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668     at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on     lung function and symptoms of COPD.   "
236404|NCT00952497|"     The objectives of this study are to evaluate the anti-tumor activity, safety, and     tolerability of telatinib when used in combination with chemotherapy (capecitabine and     cisplatin) as first-line therapy in subjects with advanced gastric cancer. The primary     objective is to assess progression free survival (PFS) in subjects receiving telatinib in     combination with chemotherapy (capecitabine and cisplatin). The secondary objectives are to     assess overall survival, overall response rate, safety and tolerability, pharmacokinetics and     biomarkers.   "
236300|NCT00949988|"     This is an open-label phase I/II study that will investigate the combination of dasatinib and     rituximab therapy in patients with relapsed/refractory CLL. In phase I, eligible subjects     will take either 100 mg or 140 mg of dasatinib daily along with rituximab on day 1 of each     cycle for 6 cycles. In phase II, eligible subjects will all receive the same dose of     dasatinib, as established in the phase I portion, along with rituximab on day 1 of each cycle     for 6 cycles.      The investigators hypothesize that the combination of dasatinib and rituximab will     demonstrate efficacy in the treatment of patients with relapsed/refractory CLL.   "
236301|NCT00950001|"     The goal of this clinical research study is to learn if stereotactic radiosurgery can help to     reduce the risk of a brain tumor returning after surgery. The safety of this treatment will     also be studied.   "
236302|NCT00950014|"     The purpose of this study is to test comprehension of five numeric formats used to present     data about treatment benefits and harms.   "
236303|NCT00950027|"     Head trauma and severe cerebral hemorrhage are major risk factors for development of     ventilator-associated pneumonia. In a previous open labelled, single center study the     investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be     an effective strategy to decrease the prevalence of ventilator-associated pneumonia in     patients with head trauma. The present study aims to confirm these results in a multicenter,     double blind study including patients suffering from head trauma or cerebral hemorrhage.   "
236304|NCT00950040|"     This study is designed to test an intervention to reduce at-risk drinking among Type 2     diabetic patients. At-risk drinking is associated with inferior diabetes treatment adherence     and control. The investigators hypothesize that our brief alcohol intervention will result in     a reduction in drinking and better diabetes treatment adherence and control. If successful,     this intervention could help diabetics to gain better control of their diabetes and live     healthier lives.   "
236305|NCT00950053|"     The purpose of this study is to determine whether Achilles tendon debridement and     decompression augmented with flexor hallucis longus (FHL) tendon transfer results in improved     clinical and functional outcome as measured by ankle plantar flexion strength and American     Orthopedic Foot and Ankle Society (AOFAS) score compared to debridement and decompression     alone in patients over 50 years of age with chronic insertional Achilles tendinosis.      H0: There will be no difference in ankle plantar flexion strength measured using a handheld     dynamometer between patients randomized to achilles tendon decompression and debridement     alone (Group 1) and patients randomized to achilles tendon decompression and debridement     augmented with FHL transfer (Group 2).      HA: Patients randomized to achilles tendon decompression and debridement alone (Group 1) will     have less ankle plantar flexion strength compared to patients randomized to achilles tendon     decompression and debridement augmented with FHL transfer (Group 2).   "
236306|NCT00950066|"     The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood     Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its     individual constituents administered as monotherapy and placebo.      The secondary objectives are:        -  to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8          weeks from baseline between each FDC, its individual constituents administered as          monotherapy and placebo.        -  to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each          FDC, its individual constituents administered as monotherapy and placebo.   "
236307|NCT00950079|"     The aim of this study is to determine whether sodium bicarbonate is superior to sodium     chloride in preventing contrast induced nephropathy in diabetic patients undergoing coronary     angiography or intervention.   "
236308|NCT00950092|"     This is a multi center, non-randomized, prospective, open label, clinical trial evaluating     the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when     used to treat patients with persistent and longstanding persistent AF during concomitant     cardiac surgery.   "
236309|NCT00950105|"     This study will be conducted in healthy male or female subjects using a double-blind,     randomized, placebo-controlled, single-dose design. Up to 30 subjects will be enrolled; 3     healthy subjects in Cohorts 1 and 2 (2 active, 1 placebo) and 8 healthy subjects in Cohorts 3     to 5 (6 active, 2 placebo). The following CPSI-2364 doses are proposed: 1 mg, 10 mg, 30 mg,     90 mg, and 270 mg.Safety will be evaluated throughout the study and include physical     examinations, vital signs assessments, 12-lead electrocardiograms (ECGs), routine clinical     laboratory tests (including blood chemistry, hematology, coagulation, and urinalysis), and     adverse event (AE) assessments. Vital sign assessments and 12-lead ECGs will be performed     repeatedly over the 24-hour observation period. Venous blood samples will be taken at     specified intervals and tested for the presence of CPSI-2364.   "
236343|NCT00950547|"     PURPOSE: Autotransfusion devices may be employed in cardiac surgery to decrease allogenic     blood requirements. Limitations of previous trials include the use of cell saver systems in     selected high risk patients only or the lack of blood transfusion-sparing strategies. The aim     of this prospective randomized study is to evaluate the efficacy of cell salvage CardioPAT     routinely used in cardiac surgery.      METHODS: The investigators will randomize 350 patients in two groups: group 1 receives a     CardioPAT cell saver device (175 patients), group 2 doesn't receive any cell saver device.     The incidence of allogenic blood transfusion and clinical outcome in both groups are     evaluated.   "
236346|NCT00950586|"     GSK1034702 is being developed for improving cognitive impairment in diseases such as     Alzheimer's disease and schizophrenia. This study will be done in healthy men and women of no     child beading potential to investigate repeated doses of the study medicine. The study will     investigate the following questions, do repeated doses of the study medicine have any     important side effects when taken by mouth? How much of the study medicine gets into the     bloodstream, and how quickly does the body get rid of it? Does the study medicine affect     memory, attention and problem-solving skills? What are the effects when the study medicine     and dextromethorphan are taken together.   "
236347|NCT00950599|"     To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects     with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12     weeks of double-blind treatment.   "
236348|NCT00950612|"     This observer blind study will assess the safety and immunogenicity of GSK Biologicals'     investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a     TB-endemic region.   "
236310|NCT00950118|"     The goal of this study is to identify genes that convey susceptibility to congenital     diaphragmatic hernia in humans. The identification of such genes, and examination of their     structure and function, will enable a delineation of molecular pathogenesis and, ultimately,     prevention or treatment of congenital diaphragmatic hernia. There are many different possible     modes of inheritance for congenital anomalies, including autosomal dominant, autosomal     recessive, and multifactorial. Multi-factorial inheritance is responsible for many common     medical disorders, including hypertension, myocardial infarction, diabetes and cancer. This     type of inheritance pattern appears to involve environmental factors as well as a combination     of genetic variations that together can predispose to or produce congenital anomalies, such     as congenital diaphragmatic hernia.      Our study is designed to establish a small, well-defined genetic resource consisting of 1)     Nuclear families suitable for linkage analysis by parametric,non-parametric (e.g. sib pairs,     TDT) and association techniques, 2) Individuals with congenital diaphragmatic hernia who can     be directly screened for allelic variation in candidate genes, and 3) Individuals who can     serve as controls (are unaffected by congenital diaphragmatic hernia). Neonates and their     families will be collected from homogenous and heterogeneous populations. By characterizing     diverse populations, it should be possible to increase the likelihood of demonstration of     genetic variation in selected candidate genes that can then be used in association and     linkage studies in individual subjects with congenital diaphragmatic hernia.   "
236311|NCT00950131|"     The purpose of this study is to test whether a new drug warning decreases enthusiasm for new     drugs.   "
236312|NCT00950144|"     RATIONALE: Studying a patient's understanding of his or her illness, pain, symptoms, and     quality-of-life may help the study of advanced cancer and may help patients live more     comfortably.      PURPOSE: This clinical trial is studying pain and symptom distress in patients with advanced     colon cancer, rectal cancer, pancreatic cancer, or liver cancer.   "
236313|NCT00950157|"     The purpose of this study is to test whether cautions about the evidence, in this case an     open questions statement, decreases enthusiasm for drugs that are approved on surrogate     outcomes (compared to patient outcomes) alone.   "
236314|NCT00950170|"     Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe     hemophilia A in patients who have not yet received treatment for their hemophilia. Study     subjects will be males less than 6 years old who have not taken any clotting factor or other     blood products before the study. The safety and effectiveness of ReFacto AF will be     determined in this study by tests and procedures done at the doctor's office.   "
236315|NCT00950183|"     This study will compares differences in pain level, narcotic consumption, wound healing,     patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho,     Inc) versus those who use ice. This will be assessed postoperatively following the foot and     ankle procedures primary first metatarsal osteotomy (PMO) or lateral ankle ligament     reconstruction (LAR).   "
236316|NCT00950196|"     Ataxia-Telangiectasia A-T is a neurodegenerative disorder of the cerebellum, manifesting with     ataxia, as well as extrapyramidal features. Treatment of A-T is discouraging, since no     treatment seems to change the course of disease, but improvement can be achieved by     symptomatic treatment of the bothersome movement disorder . While various dopaminergic agents     are occasionally used, reports of benefit are rather sparse and anecdotal. Amantadine, a well     known drug used in influenza as well as movement disorder of Parkinson, has been proved to     improve various other types of movement disorder as ataxia, chorea, dystonia, akinesia and     attention span. The purpose of this study is to investigate weather amantadine sulphate     improves ataxia and the movement disorder (bradykinesia, parkinsonism, dystonia, chorea), as     well as the general well being in patients with A-T.   "
236317|NCT00950209|"     Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality     at type 2 diabetes. The typical dyslipidemia that is associated with insulin resistance,     which includes a postprandial elevation of triglyceride-rich lipoproteins (TRLs) with excess     of intestinal triglyceride-rich-lipoprotein-apoB48 (TRL-apoB48), is felt to play an important     role in the accelerated ASCD.      The investigators' objectives in this study are to determine whether an acute elevation of     plasma insulin, secondarily to plasma insulin infusion, modulates the production and the     clearance rates of intestinal TRL-apoB48 in type 2 diabetic patients in the fed state and to     determine if this is a direct effect of insulin or an indirect effect due to the decrease of     plasma FFA or the decrease of plasma glucose.   "
236318|NCT00950222|"     The study is a prospective open trial conducted in 4 centers, and designed to determine if     pharmacokinetic (PK) and pharmacodynamic (PD) parameters of imipenem, associated with     amikacin as empirical therapy, impact microbiological and clinical outcome of patients with     Gram negative bacilli (GNB) ventilator-associated pneumonia (VAP).   "
236319|NCT00950235|"     This study will examine the safety and effectiveness of a dietary intervention in pregnant     women. Women who are obese will be invited to participate. The control arm will receive     routine prenatal care and one in-person nutritional and dietary counseling session to promote     healthy eating during their pregnancy. The intervention arm will receive a more intensive     dietary program that will include in-person counseling and group support sessions. The goal     of the intervention will be weight maintenance (weight at 2 weeks after delivery should be     within 3% of baseline weight) and avoidance of postpartum weight retention   "
236344|NCT00950560|"     The authors employ a questionary approach to understanding the relational among patients'     perceptions of inpatient, outpatient and emergency room service and their overall perceptions     of service quality, satisfaction with hospital.The questionary was applied in total 300     patients (100 inpatients, 100 outpatients and 100 emergency patients).   "
236345|NCT00950573|"     Objective:        1. To assess whether nocturnal hemodialysis and renal transplantation are associated with          less progression of coronary arterial calcification, compared with conventional          hemodialysis and peritoneal dialysis;        2. To identify the risk factors for coronary arterial calcification in dialysis and          transplant patients, and to assess a possible interaction with treatment modality.   "
236399|NCT00952432|"     The goal of the study is to utilize BCTQ(Boston Carpal Tunnel Questionnaire), VAS (Visual     Analog Scale), NCS (Nerve Conduction Study), and MET(Multiple Excitability Test) to evaluate     and compare the efficacy of Acupuncture Therapy and Carbamazepine in Patients with Carpal     Tunnel Syndrome.   "
236320|NCT00950248|"     Background:        -  Multiple sclerosis (MS) is an inflammatory disorder of the central nervous system that          progressively weakens and destroys the pathways of the nervous system. About 10 percent          to 15 percent of patients develop primary-progressive MS (PP-MS), characterized by          progressive accumulation of disability from the disease onset, without any marked          improvements or relapses. There are currently no effective treatments for PP-MS.        -  Idebenone is a manmade drug that is similar to a naturally occurring compound known as          coenzyme Q10, a common dietary supplement. Research data suggest that idebenone may be          able to limit demyelination and death of brain cells and thereby slow or halt the          progression of neurological dysfunction such as that occurring in MS.      Objectives:      - To evaluate the safety and effectiveness of using idebenone to treat primary progressive     MS.      Eligibility:      - Individuals between 18 and 65 years of age who have been diagnosed with primary progressive     multiple sclerosis.      Design:        -  The study will last 3 years and will be divided into two parts: a 1-year pretreatment          baseline and 2 years of treatment with either idebenone or a placebo.        -  Pre-treatment study: approximately 5 clinic visits over 1 year.        -  Visit 1: Comprehensive medical history and neurological examination, with brain scans          and neurological tests.        -  Visit 2: Magnetic resonance imaging (MRI) scan of the spine and lymphocytapheresis          (withdrawal of white blood cells for testing).        -  Visit 3: Lumbar puncture.        -  Visit 4: Skin biopsy.        -  Visit 5: Repeat MRI of the brain and spinal cord, as well as neurological tests; these          tests will be scheduled over 2 days.        -  After the five pretreatment visits, patients will receive a 6-month supply of study          medication (either idebenone or a placebo) to take three times a day with food        -  Patients will continue to have regular followup clinic visits with brain MRI scans,          blood tests, and other evaluations of brain and nervous system function. Randomly          selected participants will have additional MRI scans for further safety precautions.   "
236321|NCT00950261|"     The standard postoperative treatment for patients with cervical cancer who had high-risk     factors is chemoradiation. Generally, weekly cisplatin or 5FU+cisplatin every 3 week have     been used as chemotherapy regimens of chemoradiation. Based on their experience, the     investigators hypothesized that tri-weekly cisplatin could be superior to weekly cisplatin.     Therefore, the investigators are going to perform the efficacy study of postoperative,     tri-weekly cisplatin chemoradiation for patients with cervical cancer.   "
236322|NCT00950274|"     In spite of the fact that the post-myocardial infarction survival rate has improved with     recent medical advances, reduced heart function attributed to irreversible loss of viable     cardiomyocytes is still a major clinical problem.      The aim of the current study is to determine whether intramyocardial injection of autologous     CD133+ bone marrow stem cells yields a functional benefit in addition to coronary artery     bypass graft (CABG) surgery in patients with chronic ischemic coronary artery disease.   "
236323|NCT00950287|"     Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with     short term complications and alterations in neurodevelopment. Duration and amplitude of the     bradycardias depend on the time delay between the beginning of the bradycardia and the     intervention of the nurse.      The purpose of the study is to test a new method set for early detection of bradycardia in     preterm infants.   "
236324|NCT00950300|"     In this open-label multicenter trial, participants with operable or locally advanced breast     cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles     of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide)     concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive     a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of     treatment. All cycles will be 21 days in length. After the end of study treatment,     participants will be followed for safety and efficacy for up to 5 years or until disease     recurrence, whichever is earlier.   "
236325|NCT00950313|"     The purpose of this study is to establish the most effective method of increasing attendance     to screening of type 2 Diabetes within a primary care setting within the backdrop of the NHS     Health Check programme.   "
236326|NCT00950326|"     The study design consists of a prospective randomised controlled three-armed clinical trial,     which will be carried out at a specialist clinic for integrative medicine, to investigate the     clinical effects of hydrotherapy on osteoarthritis of the knee or hip joint, in comparison     with conventional physiotherapy.   "
236327|NCT00950339|"     Current guidelines recommend the addition of proton pump inhibitors (PPI) to patients taking     double anti-platelet therapy (Aspirin and Clopidogrel) to prevent upper GI bleeding1. Many     post percutaneous coronary intervention (PCI) patients are treated with dual anti-platelet     medications as well as PPI to prevent upper GI bleeding.      Recently, it was shown that PPI interact with the P450 system in the liver and reduce the     platelet inhibitory effect of Clopidogrel2,3. Clopidogrel is activated by CYP2C19, which also     metabolizes PPI4. Furthermore, a recent article showed increased mortality in patients taking     PPI and clopidogrel compared with patients taking clopidogrel without PPI protection5. The     degree of reduction in the platelet inhibitory properties of clopidogrel might vary among the     different PPI4.      The use of PPI for GI protection in patients treated with dual anti-platelet therapy is not     based on randomized trials, but rather on expert opinion. Since H2 blockers are also     effective in preventing acid secretion and are not known to interact with the P450 system     that affects clopidogrel, the investigators hypothesized that these group of drugs will not     interfere with the positive antiplatelet effects of clopidogrel and therefore will offer a     good alternative treatment option.   "
236328|NCT00950352|"     The purpose of the study is to determine if citicoline (a nutritional supplement) is     effective in helping people reduce their dependence on methamphetamine. The investigators     will use neuroimaging to look at the structure and chemical make up of the brain at the start     of the study and after 8-9 weeks of treatment of citicoline or placebo.   "
236329|NCT00950365|"     RATIONALE: Erlotinib may stop the growth of tumor cells, and even shrink the tumors in some     patients, by blocking some of the enzymes such as epidermal growth factor receptor (EGFR)     needed for cell growth and spread. Pemetrexed is a drug that inhibits several key proteins     that require folic acid to synthesize DNA. Blocking DNA synthesis in tumor cells has been     shown to decrease tumor growth. can block tumor growth in different ways. Giving erlotinib     together with pemetrexed at a specific schedule may kill more tumor cells than giving only     pemetrexed.      PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib and     cetuximab and to see how well they work in treating patients with advanced solid tumors or     progressive or recurrent stage III or stage IV non-small cell lung cancer.   "
236330|NCT00950378|"     The purpose of this study is:      -item one to use two new non-invasive technologies to evaluate scarring and swelling     associated with chronic venous insufficiency.      The study hypothesis:      - item one non-invasive technologies can provide a tool for assessing risk of ulcer     development based on the tissue edema and alteration.   "
236331|NCT00950391|"     Tacrolimus (FK506) is an immunosuppressive medication that promotes organ allograft survival.     It has also been shown to enhance nerve regeneration and muscle reinnervation in animals but     these properties have not previously been studied in patients. Moreover, currently there is     no method in clinical use to speed the rate of recovery after nerve injury. The objective of     this study is to explore the ability of tacrolimus to benefit the treatment of patients with     peripheral nerve injury. To minimize the morbidity of tacrolimus therapy, its phase-specific     effects on nerve regeneration and muscle reinnervation will be defined in the murine model to     permit further limitation of the duration of therapy. The investigators hypothesize that     treatment with tacrolimus after autogenous peripheral nerve reconstruction will accelerate     nerve regeneration, reduce the period of denervation and improve muscle reinnervation and     recovery in patients with peripheral nerve injury.      There are 2 specific aims:        1. Determine the safety and efficacy of tacrolimus following reconstructive nerve surgery          in a double-blind placebo-controlled randomized pilot clinical trial of patients with          severe nerve injuries of the extremities;        2. Correlate the quality of life outcome with assessment of functional recovery after          surgical reconstruction of patients with severe peripheral nerve injuries of the          extremities.   "
236332|NCT00950404|"     The bioavailability of the oral disintegrating tablet formulations given without water will     be similar to an equivalent dose of the standard oral tablet given with water.   "
236333|NCT00950417|"     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located     in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical     efficacy has been shown in adult with head and neck cancer. The phase I study assessed the     safety, and efficacy of the combination of Nimotuzumab administered concomitantly with     chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.   "
236334|NCT00950430|"     This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of     this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to     ascertain the relationship between change in amyloid burden over time, and concurrent change     in clinical status.   "
236335|NCT00950443|"     Upper airway obstruction (UAO) is very common in children. Presently, the importance of the     UAO is evaluated by the physician during an endoscopic evaluation under general anaesthesia.      The aim of the study is to evaluate two new techniques to quantify the importance of the UAO     in children; the acoustic reflection method and the measurement of the work of breathing.      80 children will be included in this monocentric, prospective, open labelled study.   "
236336|NCT00950456|"     The purpose of this observational study, which will be initiated as soon as the licensed H1N1     Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the     incidence of any medically-attended adverse events in all vaccinated subjects.   "
236337|NCT00950469|"     OBJECTIVES/BACKGROUND: We sought to determine the early diagnostic value of the new high     sensitive cardiac troponin T assay (TnThs) in suspected acute coronary syndrome (ACS) and to     compare it with the 4th generation cTnT assay from the same manufacturer, myoglobin and     heart-type fatty acid binding protein (h-FABP).      METHODS: The study consisted of 94 patients with chest pain admitted to the chest pain unit     with the diagnosis of suspected ACS without ST-Elevation. Patients were divided according to     time from onset of symptoms to presentation into an early presenter group (<4 hours) and a     late presenter group (≥4 hours).      A median of 6 samples (range 2-8) were available per patient. The diagnostic performance of     TnThs was assessed using ROC analysis and areas under the curve (AUC) of baseline and     follow-up results of TnThs, cTnT, myoglobin, and h-FABP were compared using c-statistics.      RESULTS: The TnThs assay allows an excellent prediction of non-ST-segment-elevation     myocardial infarction (non-STEMI) at presentation.A follow-up sample improves diagnostic     performance in a time dependent manner. The AUC of the TnThs was superior to cTnT at all time     points.      CONCLUSIONS: A baseline sample of TnThs allows an earlier prediction of non-STEMI than the     less sensitive and precise 4th generation cTnT assay. The excellent performance of TnThs at     baseline and follow-up might obviate the need for other early necrosis markers.   "
236338|NCT00950482|"     This pilot project is a randomized research study to examine the effects of acupuncture on     menopausal symptoms. The investigators will recruit up to 45 Cedars employees (excluding Dr     Bairey Merz's employees) with menopausal symptoms by posting a study flyer on Exchange. If a     patient is interested in this study, she may contact the research team for further     information. Once a patient is identified as being eligible for the study, she will be     contacted to schedule the screening visit. They will receive an explanation of the study.     They will be sent the consent form to review prior to the initial visit. At the initial     visit, prior to any study-related procedures, the consent will be reviewed with the patient.     After all questions have been answered and the patient appears to fully understand the study,     the patient will be asked to provide written consent.      This pilot project will collect data from three study groups as stated in the NIH application     proposal. The first research study group will undergo traditional acupuncture (TA). The     second research study group will receive alternative acupuncture (AA). The third group will     be a waiting control group (WC) that will receive four weeks of acupuncture following     completion of the study duration.      Traditional acupuncture means that the needle is inserted in true acupuncture point     locations. Alternative acupuncture is a technique that varies slightly from traditional     acupuncture and is used to assess which technique, if any, produces the best therapeutic     results. Waiting control is a group of subjects who get neither traditional nor alternative     acupuncture during the duration of treatment, which in this case, is 3 months.      Patients will be randomized into one of the three study groups, and will have one in three     chance of being placed in one of the three groups. Neither patients nor the investigators can     choose which group patients are assigned to. Patients from TA and AA groups will be asked to     come to Cedars-Sinai a total of 39 times (36 sessions and 3 clinic visits) over a three-four     month period. It will compare the effects (good or bad) of traditional acupuncture (TA) with     alternative acupuncture (AA) on the menopausal symptoms to be studied in this research.     Patients from WC group will be asked to come to Cedars-Siani a total of 15 times. Other study     procedures include physical exam, blood and urine collection for hormone tests, questionnaire     interview, etc.      During the pilot phase of this study subjects will record the number of mild, moderate,     severe and/or very severe hot flashes that occur each day in a hot flash diary. There is also     an option for patients to record other symptoms they may experience during that week other     then hot flashes as well as a place for additional comments. Subjects will complete the diary     for seven consecutive days. It is a simple form that takes very little time to complete each     day (only 5-10 minutes) and will not impact the duration of the study participation.      No genetic study will be conducted in this pilot project.   "
236339|NCT00950495|"     The aim of the study was to compare the effects of a mandibular advancement device (MAD) with     those of nasal continuous positive airway pressure(nCPAP) and of an intra-oral placebo device     in obstructive sleep apnea (OSA) patients. The hypothesis for this study was that both MAD     therapy and nCPAP therapy have similar, better treatment effects than placebo therapy in OSA.     The study was performed according to the CONSORT (consolidated standards of reporting trials)     statement (Altman et al., 2001), employing a parallel-group, randomized, placebo-controlled     trial design.   "
236340|NCT00950508|"     The aim of this study is to examine if high-volume plasma exchange has a positive effect on     mortality in patients with acute liver failure.   "
236349|NCT00950625|"     Although laparoscopic cholecystectomy is associated with less pain than contemporary open     procedures; it is definitely not pain free and the magnitude of postoperative shoulder and     abdominal pain in the early postoperative period is still quite significant. This     postoperative pain is a major concern not only for the patients, but also healthcare workers;     and it often contributes to overnight hospital stay after this minimally invasive surgical     procedure. Intraperitoneal instillation of local anesthetics at the time of surgery to     control pain after laparoscopic cholecystectomy has been extensively studied in numerous     randomized trials and found to be extremely useful. Lignocaine and Bupivacaine are two     commonly used local anesthetic agents. In view of contradictory results from previous     studies, it is not yet clear which of these two agents is superior to the other for pain     control in this setting. To answer this question, we have designed a prospective randomized     controlled trial and the specific aim of the study is to compare the analgesic efficacy of     intraperitoneal lignocaine with intraperitoneal Bupivacaine in the postoperative setting     after laparoscopic cholecystectomy.      If we can improve pain control after this minimally invasive procedure, it might result in     decreased postoperative requirement of narcotic analgesia and its associated side-effects. It     may also result in early recovery and the same day discharge of the patients with significant     cost-containment for the patient and healthcare systems in future.   "
236350|NCT00950638|"     The objectives of this study are to evaluate the safety and tolerability of ARC1905     intravitreous injection in subjects with geographic atrophy secondary to dry age-related     macular degeneration (AMD).   "
236351|NCT00950651|"     A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to     compare the efficacy, safety, and clinical benefit of the test and reference product after     treatment for 84 days in patients with osteoarthritis of the knee.   "
236352|NCT00950664|"     1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in          comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment          of Cervical dystonia.        2. double blind, randomised, multi center, crossover study   "
236353|NCT00950677|"     The purpose of this study is to see if giving study drugs before a meal may lower blood     sugars after the meal. An improvement in blood sugar control may prevent long-term problems     of diabetes.   "
236354|NCT00950690|"     Efficacy data was not collected or analyzed. This study did assess safety and tolerability of     Xalatan.   "
236355|NCT00950703|"     1. Assessing the perception of Canadian Primary Care Physicians towards global          cardiovascular risk assessment.        2. Correlating physician perceptions to actual practice data, gathered via a retrospective          chart audit.        3. Evaluating the impact of a prospective educational and peer-practice pattern          intervention on future assessment o cardiovascular risk and        4. Assessing the role of carotid atherosclerosis assessment(Carotid IMT and plaque) as an          adjunct to global risk prediction.   "
236356|NCT00950716|"     Quality diabetes care requires informed-decisions of motivated care providers and diabetes     patients. The investigators aim to use peer support and information technology to facilitate     care providers to implement structured care and empower diabetes patients acquire     self-management skills in a multi-component program.      The investigators will make use of the following tools: (1) The Joint Asia Diabetes     Evaluation (JADE) Program. JADE Program uses a web-based electronic portal to establish a     registry and stratify diabetes patients to care protocols based on their risk profiles with     features of decision support and data management. (2) The Australasian Telephone Linked Care     (TLC) system. TLC system utilizes an automatic, interactive, computer-controlled telephone     system to monitor and promote diabetes self-management.      Amongst 600 diabetes patients receiving structured care in Hong Kong through the JADE     Program, half of them will be randomized to receive peer support (n=300) including personal     coaching by 30 trained mentors (1 mentor to 10 diabetes patients or mentees) through regular     phone calls and sharing sessions, and the other half (n=300) will continue the usual diabetes     care in their clinic. The 30 mentors are themselves diabetes patients who have good self care     and are motivated to support their peers. The mentors will be trained to deliver peer support     intervention under supervision by a program manager. The 300 diabetes patients (mentees)     randomized to the peer support group are the intervention targets of these 30 mentors. They     will be reminded to use the TLC for knowledge enhancement and motivational support.      The investigators will analyse the changes in risk factor control (blood glucose parameters,     blood pressure, body weight, lipids), quality of life and cognitive-psychological-behavioral     parameters after 12 months. Effects of various components of peer support on these outcomes     as well as user acceptability and cost-effectiveness of these programs will be examined.      The investigators will test the hypothesis that in a multi-component program, the use of a     peer support program delivered by diabetes patient-mentors, to influence and motivate other     diabetes patients receiving structured care made possible through a web-based disease     management program, delivered by a doctor-nurse team, will further improve metabolic control,     QOL and self care compared to diabetes patients receiving the same standard of care.   "
236357|NCT00950729|"     Abstract Background: Effects of orthopedic immobilizations of the lower right limb on driving     performances are unknown. Therefore, clinicians and legislators cannot put forth     recommendations for road safety for patients requiring such immobilizations. The objective of     the present study was to evaluate the effects of different orthopedic immobilizations on     braking performances in simulated driving conditions.      Methods: The braking performances of 48 healthy volunteers were evaluated under 3 conditions:     wearing their running shoes, and 2 types of orthopedic immobilizations of the lower right     limb, a walking cast and an Aircast walker. A computerized driving simulator was used to     measure the maximum force applied on the brake pedal during braking, the braking reaction     time and the total braking time during emergency braking with and without a distracter.   "
236358|NCT00950742|"     Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with     Herceptin®   "
236400|NCT00952445|"     The purpose of the study is to determine if repeated daily doses of T0903131 (INT131)     Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes     Mellitus.   "
236359|NCT00950755|"     This is a single-arm, open-label study of Iodine 131 Anti B1 Antibody for the treatment of     1st or 2nd relapsed indolent B cell lymphomas or B cell lymphomas that have transformed to a     more aggressive histology. The primary endpoint of the study is to determine the response     rate. Secondary endpoints of the study is to determine the duration of response, time to     progression, time-to-treatment failure, safety, and survival.      Forty patients will receive therapy on this study at the 2 clinical sites. Patients will     undergo 2 phases of the study. In the first phase, termed the dosimetric dose, patients     will receive an infusion of unlabeled Anti B1 Antibody (450 mg) over 70 minutes (including a     10 minute flush) immediately followed by a 30 minute infusion (including a 10 minute flush)     of Anti B1 Antibody (35 mg) which has been trace-labeled with 5 mCi of Iodine 131. Whole body     gamma camera scans will be obtained on 1) Day 0; 2) Day 2, 3, or 4; and 3) Day 6 or 7     following the dosimetric dose. Using the dosimetric data from the 3 imaging timepoints, a     patient-specific dose of Iodine 131 Anti B1 Antibody to deliver the desired total body dose     of radiotherapy will be calculated. In the second phase, termed the radioimmunotherapeutic     dose, patients will receive a 70 minute infusion (including a 10 minute flush) of unlabeled     Anti B1 Antibody (450 mg) immediately followed by a 30 minute infusion (including a 10 minute     flush) of 35 mg Anti B1 Antibody labeled with the patient-specific dose of Iodine 131 to     deliver a whole body dose of 75 cGy to patients with no hematologic risk factors. Patients     who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy and patients who     are obese will be dosed based upon 137% of their lean body mass (see Appendix A). Patients     will be treated with either saturated solution potassium iodide (SSKI), Lugol's solution, or     potassium iodide tablets starting at least 24 hours prior to the first infusion of the Iodine     131 Anti B1 Antibody and continuing for 14 days following the last infusion of Iodine 131     Anti B1 Antibody (i.e., therapeutic dose).   "
236360|NCT00950768|"     In this study will be randomised before induction treatment either to receive two courses of     melphalan 200 mg/m2 (MEL200) or two courses of melphalan 100 mg/m2 (MEL100). Informed consent     will be obtained upon enrolment. Inclusion criteria included: diagnosis of untreated Durie e     Salmon stage IIA-IIIB measurable multiple myeloma; age < 65 years. Exclusion criteria     included: prior treatment for myeloma; abnormal cardiac function, defined as systolic     ejection fraction <50%; abnormal pulmonary spirometry test; serum bilirubins > 2.5 times     normal and ALAT and/or ASAT > 2 times normal; seropositivity for HIV, HCV or HBV, active     non-hematologic malignancies.      Induction therapy, PBSC mobilization, and autografting Initial treatment plan included     induction chemotherapy with 2 courses of vincristine, 1 mg/m2 on day 1, adriamycin, 50 mg/m2     on day 1, and dexamethasone, 40mg/day days 1-4, administered 28 days apart, followed by     peripheral blood stem cell (PBSC) mobilisation and harvest after 1 or 2 cycles of     cyclophosphamide, 4 g/m2, and G-CSF, 10 ug/kg given i.v. or subcutaneously. After at least     one month from PBSC collection, autografting consisted of melphalan, 200 mg/m2 or melphalan,     100 mg/m2, on day -2, and cryopreserved PBSC infusion on day 0. Patients received G-CSF, 5     ug/kg, from days +3 until neutrophil count > 1000/ul were achieved.      Supportive care and toxicity grading Following autografting, all patients received standard     prophylaxis against bacterial and fungal infections; herpes simplex and varicella-zoster     virus reactivation; and Pneumocystis carinii. Cytomegalovirus CMV reactivation was monitored     through levels of CMV antigenemia and/or serum CMV DNA levels and treated with ganciclovir or     foscarnet as clinically indicated. Standard criteria (Common Toxicity Criteria version 3.0)     were used for grading hematological and non-hematological toxicity.   "
236361|NCT00941642|"     Lovaza is the only fish oil supplement approved by the FDA. It is available by prescription     for the treatment of hypertriglyceridemia (> 500 mg/dl). The primary mechanism appears to be     a reduction in hepatic production of triglycerides. Also decreases the hepatic production of     very low density lipoprotein (VLDL). There also may be antioxidant properties as well. The     thought behind using Lovaza as a treatment for non-alcoholic fatty liver disease (NAFLD) is     two fold. It would help in the decrease production of triglycerides by the liver and have     antioxidant properties decreasing the production of free radicals in the liver. In doing so,     steatohepatitis, fibrosis, and perhaps cirrhosis and liver cancer would be prevented.   "
236362|NCT00941655|"     Background:        -  Gastric (stomach) cancer is a rare cancer. In most cases, by the time it has been          diagnosed it has spread to other organs in the body and the chance of a cure is very          small. The standard treatment for gastric cancer is a combination of chemotherapy drugs.        -  Researchers are interested in finding out if surgically removing all tumors before          beginning chemotherapy for stomach cancer can slow or halt its spread better than giving          chemotherapy alone.      Objectives:      - To determine whether tumor removal surgery followed by chemotherapy is more effective in     treating gastric cancer than chemotherapy given alone.      Eligibility:      - Patients 18 years of age and older who have been diagnosed with gastric cancer.      Design:        -  All patients will undergo an initial physical examination, blood tests, imaging scans,          and a laparoscopy to determine the extent of the disease.        -  Half of the participants will be assigned to have surgery first and then chemotherapy;          the other half will be assigned to have chemotherapy alone.             -  The surgery-plus-chemotherapy group will have major surgery to remove all tumors in               the stomach and abdominal area, followed by a recovery time of up to 4 weeks.               Chemotherapy will begin 6 to 8 weeks after surgery.             -  The chemotherapy-only group will begin treatment within 2 weeks of laparoscopy.        -  All patients will receive four chemotherapy drugs: 5-Fluorouracil, leucovorin,          oxaliplatin, and irinotecan. The drugs are given intravenously over 2 days every 2 weeks          (one cycle) for 12 cycles (about 6 months), either at the National Institutes of Health          (NIH) Clinical Center or at home with a referring oncologist. Patients in the surgery          group who have tumors in the peritoneum will receive an additional set of chemotherapy          drugs in a separate treatment.        -  During the chemotherapy cycles, patients will provide blood samples approximately once a          week and will have physical examinations and scans on a regular basis.        -  Patients will return to the NIH Clinical Center for follow-up visits about every 4          months for 2 years, then every 6 months for 3 years and yearly thereafter.   "
236363|NCT00941668|"     The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice   "
236364|NCT00941681|"     This study is designed to understand the pharmacokinetics of different oral formulations of     CK-1827452 being considered for future studies in patients with heart failure. This study     will compare the pharmacokinetics and safety and tolerability of both modified-release (MR)     and immediate-release (IR) oral formulations of CK-1827452.   "
236365|NCT00941694|"     Asthma self-management is an effective way to improve the outcomes of patients with asthma.     However, to be most effective these interventions should be targeted and designed toward a     specific population or group. There is currently no asthma self-management intervention     directed towards older adults. The hypothesis is that a 6-session asthma self-management     intervention will improve the outcomes of older patients with asthma.   "
236366|NCT00941707|"     The purpose of this study is to evaluate the efficacy, tolerability and safety of     JNJ-38518168 compared with placebo in adult participants with active rheumatoid arthritis     (long time systemic disease of the joints, marked by inflammatory changes in the synovial     membranes and bones) despite methotrexate (MTX) therapy.   "
236367|NCT00941720|"     RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the     growth of cancer cells by stopping them from dividing or killing them. An autologous stem     cell transplant may be able to replace the blood-forming cells that were destroyed by the     chemotherapy.      PURPOSE: This phase II trial is studying how well giving busulfan together with     cyclophosphamide followed by an autologous stem cell transplant works in treating patients     with multiple myeloma.   "
236368|NCT00941733|"     This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with     critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of     the infrapopliteal vessels. Patients will undergo a percutaneous transluminal endovascular     procedure with either the IN.PACT Amphirion™ drug eluting balloon or with a standard     (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with     pre-study, post-study, and follow-up evaluations.   "
236426|NCT00952783|"     This study is designed to follow up patients, who have achieved complete clearance of AK     lesions (lesion count of 0) at Day 57 in the PEP005-020 study, over a 12 month period to     assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected     treatment area.   "
236377|NCT00950885|"     Melatonin supplements have been reported to be an effective treatment for circadian rhythm     sleep disorders, including shift work dyssomnia, jet-lag, delayed sleep phase syndrome, and     sleep disruption suffered by many blind individuals. However, the mechanism(s) by which     melatonin affects the timing of sleep are not well-understood. The purpose of this study is     to determine if melatonin improves sleep and performance on a schedule simulating eastward     travel. This study will provide information regarding the mechanism of action of melatonin     that will be critical for the use of melatonin as a treatment for circadian rhythm sleep     disorders.   "
236378|NCT00950898|"     The purpose of this study was to determine the acute effects of decaffeinated coffee,     caffeinated coffee and caffeine on glucose metabolism in humans   "
236379|NCT00950911|"     The purpose of this study is to describe the safety and tolerability of denosumab     administration as measured by adverse events, immunogenicity, and safety laboratory     parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.   "
236369|NCT00950781|"     This is an ancillary study to Protocol 16997 to examine the stress hormone level in women     with menopausal symptoms. This ancillary project will collect additional data from the 45     subjects enrolled in Protocol 16997 (no subjects have enrolled in Protocol 16997 so far).     This study protocol differs from the main protocol (16997) because it will include an ACTH     (Hormone) Stimulation Test which will assess the functioning of stress response in the     subjects at entry and exit.      Subjects will undergo the ACTH test for this ancillary protocol in the morning when they     complete 24-hour urine collection for Protocol 16997. The ACTH (Hormone) Stimulation Test     will not be done in the main protocol 16997. During the ACTH test an IV will be placed in     subjects arms, 25mL of blood will be drawn at -30 minutes and 6mL of blood will be drawn at     -15 minutes and 0 minutes respectively. Following, 0.25mg of ACTH will be injected     intravenous over 60 seconds, and a final 12mL of blood will be drawn 60 minutes later. That     is, a total of 50mL of blood will be drawn to test serum blood hormone levels from the     subjects during the ACTH (Hormone) Stimulation Test.      The 24 hour cortisol data collected in the main protocol 16997 will be used for this study     analysis.      When subjects are consented for Protocol 16997, they will also be consented for this     ancillary study. In addition to the consent visit, subjects will have two study specific     visits (entry and exit) for this ancillary study. The PI will schedule the specific visits     for this study to be in conjunction with those scheduled for Protocol 16997.      There is no collaborations with other sites in the ancillary study.   "
236370|NCT00950794|"     To demonstrate the efficacy (non-inferiority) of Salmeterol 50mcg bid (100mcg/day), compared     with Hokunalin (tulobuterol) tape 2mg once a day, in terms of improvement in pulmonary     function (peak expiratory flow: PEF) in a randomized, double-blind, parallel-group     comparative study in adult patients with bronchial asthma on ICS 400mcg/day of FP equivalent.   "
236371|NCT00950807|"     The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared     with placebo in subjects with COPD.   "
236372|NCT00950820|"     The purpose of this interventional study is to investigate whether there is evidence that     panitumumab in combination with XELOX (capecitabine plus oxaliplatin) chemotherapy will     safely increase progression-free survival, above that of XELOX alone in subjects with KRAS     wild-type metastatic colorectal cancer who have not responded to or progressed after first     line therapy with irinotecan and a fluoropyrimidine.      Further Objectives Exploratory objectives may include investigation of potential correlations     between the treatment regimen and epidermal growth factor receptor (EGFR) expression,     detection of the functional genetic polymorphisms of the EGFR gene, EGFR gene amplification     (FISH), EGFR downstream protein and gene expression parameters, proteomics and epigenetics.   "
236373|NCT00950833|"     The objective of this study is to evaluate the immune memory through the administration of an     additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody     persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H.     influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate     vaccine GSK1024850A in previous primary and booster studies. For subjects that did not     receive the investigational vaccine during the primary and booster study, the objective is to     evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK     Biologicals' pneumococcal conjugate vaccine GSK1024850A.      This protocol posting deals with objectives & outcome measures of the extension phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT00370318). The objectives & outcome measures of the booster phase are presented     in a separate protocol posting (NCT00496015).   "
236374|NCT00950846|"     The purpose of this study is to determine the safety and effectiveness of Umbilical Cord     Blood Transplant (UCBT) to treat the patient's disease, and to see if this treatment can     decrease the incidence of GVHD.      This study is for patients that were born with a disease that affects their body's metabolism     or immune system. The doctor plans to treat the patient for this illness with a stem cell     transplant.      While improved medical care has allowed many people with these diseases to live longer, the     only way to truly cure the diseases is by means of a stem cell transplant from a donor who     does not have the disease. A stem cell transplant will replace sick cells with new healthy     donor cells. Stem cells grow into different types of blood cells that people need, including     red blood cells, white blood cells, and platelets. In a stem cell transplant, the patients     own stem cells would be killed by chemotherapy drug and then replaced by stem cells from the     donor. Stem cells can be collected from the bone marrow, peripheral blood or umbilical cords.     In this study, umbilical cords will be the source of the stem cells.      Currently, large inventories of umbilical cord blood units are available in public banks for     transplantation in those lacking bone marrow donors. UCB transplants offer several advantages     over adult bone marrow or peripheral blood stem cell transplants, including:        1. Rapid availability,        2. Absence of donor risk,        3. Low risk of transmissible infectious diseases,        4. Low risk of acute GvHD (as compared to recipients of unrelated donor marrow and          peripheral blood cells).      The two main causes of death after umbilical cord blood transplantation for disorders for     these kinds of patients, are graft failure and infection.      In this study we are trying to address these two problems by using different drugs to prepare     patients for the transplant.      To help improve engraftment (cells begin to grow), we will include the drug Fludarabine to     the usually used Busulfan and Cytoxan that the study patients will receive before their     transplant.      We will try to decrease the chance of developing graft-versus-host disease (GvHD) by using     Cyclosporin A (CSA) and Mycophenolate Mofetil (MMF), instead of Anti-Thymocyte Globulin (ATG)     which is normally used.   "
236375|NCT00950859|"     Integrase is an enzyme produced by HIV so that the virus can multiply in the human body.     GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from     working properly and therefore prevents the virus from multiplying.      GSK1349572 has shown to be effective against viruses in a short-term monotherapy study in     adults with no previous exposure to integrase inhibitors. The purpose of this study is to     determine whether GSK1349572 is effective in the treatment of HIV-infected patients who no     longer respond to treatment with the approved integrase inhibitor raltegravir and carry     viruses with resistance to this drug. The safety and efficacy of GSK1349572 50mg once daily     in combination with the background HIV drugs previously administered (unless discontinuation     of a particular drug is required) will be assessed over 10 days (functional monotherapy     phase), followed by the evaluation of the safety and efficacy of GSK1349572 given with a new     optimised background regimen from Day 11 through at least Week 24.   "
236376|NCT00950872|"     The objectives of this clinical trial are the overall performance and safety of the ENDO GIA     Staplers with ENDO GIA SULUs with Duet TRS TM.   "
236397|NCT00952406|"     Study Aims:        1. To validate a new measure of sexual function and activity in women with PFDs;        2. To establish the responsiveness to change of the new measure.      The investigators hypothesis is that the investigators can create a new questionnaire that     accurately measures sexual health in women with pelvic floor disorders that improves on the     already published questionnaires.   "
236380|NCT00950924|"     Axial hyperopia results when the length of the eye is too short for the eye to properly focus     distance objects on the retina while the focusing system is relaxed. Emmetropization is the     process by which the eye actively adjusts various components of the eye to gradually improve     the focus of the eye. Emmetropization frequently involves either an increase or a decrease in     the growth of the eye, particularly during infancy and childhood. Numerous animal studies     suggest that if an animal is exposed to retinal images located behind the retina either     centrally or peripherally, the eye will grow in the direction of the focused image. If an     abnormally short eye has resulted in hyperopia, exposing such an eye to retinal images     partially located behind the retina might encourage axial elongation, thus reducing the     hyperopia.   "
236381|NCT00950937|"     The purpose of this study is to compare oxidative stress markers and the immunologic     characteristics of HIV-infected and non-HIV subjects during a bout of moderate aerobic     exercise followed by resistance exercises   "
236382|NCT00950950|"     The purpose of this study is to evaluate the effect of AMG 785 on parameters of bone quality     of the forearm using peripheral Quantitative Computed Tomography (pQCT) following multiple     subcutaneous dose administrations of AMG 785 in postmenopausal women with low bone mass.   "
236383|NCT00950963|"     The current project is evaluating the effect of a nurse-administered phone care in diabetes     to improve access to care and healthcare delivery. The setting is a federally qualified     community health center serving over 1600 diabetic patients, 80% of whom are Latino. Using     our diabetes registry, we have randomly assigned 762 patients to either participate in a     telephone-based, nurse-run outreach program (N=381) or to continue with usual care(N=381).     Three of our registered nurses learned algorithms addressing management of cholesterol, blood     pressure, kidney disease, aspirin use, eye screening, and pneumovax and influenza vaccines.     The program began recruitment in September 2005 and has finished follow up in May 2007. The     program initially focused only on cholesterol management utilizing national guidelines and     algorithms on patients with elevated cholesterol (LDL) levels but has expanded to include     glycemic and blood pressure control. We found that Registered Nurses were able and willing to     provide telephone care to diabetic patients according to moderately complex algorithms and to     track patient data electronically with overall job satisfaction. Overall, the nurses have     expressed enthusiasm but have also experience frustrations with maintaining contact and     improving motivation in patients. The impact of this program on diabetes outcomes and its     cost-effectiveness is currently being analyzed with the goal of implementing this program in     our institution.   "
236384|NCT00950976|"     To determine the level of citrulline to produce a given amount of arginine in healthy     volunteers and surgical patients. Arginine-related amino acids are expected to increase as a     result of increased substrate provided by citrulline.   "
236385|NCT00950989|"     Randomized, double-blind, placebo-controlled study in subjects with RA who have an inadequate     response to methotrexate.   "
236386|NCT00951002|"     The purpose of this study is to determine whether human acellular dermal matrix plug is     effective in the treatment of anal fistula   "
236387|NCT00951015|"     This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal     once daily dose of GSK1349572 from a range of doses for future evaluation.   "
236388|NCT00951028|"     This study will test a therapy for both helping people adhere to their HIV medication     regimens and treating them for depression.   "
236389|NCT00951041|"     The purpose of the study is to evaluate the safety and immunogenicity of GSK Biologicals'     influenza vaccine GSK2340272A.   "
236390|NCT00951054|"     The purpose of this study is to determine whether NK012 is safe and effective in the     treatment of advanced and metastatic triple negative breast cancer.   "
236391|NCT00951067|"     The purpose of this study is to determine how well different treatments for acquired     lymphedema work.      The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm     to see which treats lymphedema best.   "
236392|NCT00951080|"     The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT)     device called the SNaP device compared to a traditional NPWT device for the treatment of     lower extremity diabetic and venous ulcer wounds.   "
236393|NCT00951093|"     The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal     reflux disease (GERD) in morbidly obese patients.   "
236394|NCT00951106|"     The purpose of this study is to determine the efficacy of pyrimethamine/sulfdoxine     (Fansidar®) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon.     Reports in the mid 1990s indicated that Fansidar was failing to cure patients with confirmed     falciparum malaria. The study design was based on accepted WHO parasitological and clinical     outcomes to determine the overall efficacy of Fansider and inform the Peruvian National     Malaria Control authorities as to the continued wisdom of recommending Fansidar as first line     treatment for uncomplicated falciparum malaria in the Peruvian Amazon.   "
236395|NCT00952380|"     Three month treatment of acute VTE with Fragmin in pediatric cancer patients   "
236396|NCT00952393|"     The study determines if a new preparation of a drug designed to treat schizophrenia is more     slowly released into the body.   "
236401|NCT00952458|"     This randomized study investigates the benefits of an additional Bispectral Index monitoring     of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral     index (BIS) monitor is a neurophysiological monitoring device which continually analyses a     patient's electroencephalograms during general anaesthesia to assess the level of     consciousness during anaesthesia.   "
236402|NCT00952471|"     Selective redesign of order sets using different ways to frame the order and physician     decision-making in a computerized provider order entry system could increase adherence to     evidence-based care and reduce population-specific variance.   "
236403|NCT00952484|"     This clinical trial studied the safety and efficacy of asfotase alfa in children with HPP     compared to a historical control group.   "
236430|NCT00952848|"     RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients     who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer.      PURPOSE: This phase II trial is studying how well MC5-A Scrambler therapy works in reducing     peripheral neuropathy caused by chemotherapy.   "
236405|NCT00952510|"     Rationale: Neck complaints are often caused by motor vehicle accidents and particular after     rear-end collision. Patients complain about neck pain after a whiplash trauma, which lead to     mobility restrictions of the cervical spine. It is estimated that 20% develop a chronic pain     disorder after 1 year, called a chronic whiplash syndrome.      Objective: the primary objective is to investigate the natural course of active-and passive     range of motion and principally the difference score between active-and passive cervical     range of motion after a whiplash trauma. The secondary objectives are: investigate the     predictive value of active-and passive range of motion and chronicity. Further, the     correlation between the degree of restriction of the active and passive backward flexion and     chronicity will be investigated. Finally, the correlation between the possible predictive     factors such as pain, ideas and feeling about pain, memory and attention, events of the last     year and complaints after the motor vehicle accident and chronicity are examined.      Study design and study population: a prospective cohort of 100 whiplash patients which     underwent a measurement of the cervical movements and gave permission to recontact them for     further research.   "
236406|NCT00952523|"     A study to compare the skin irritation potential of two marketed gels for acne treatment,     each applied to half of the face of healthy volunteers.   "
236407|NCT00952536|"     There are 3 hypotheses to be tested:        1. That daily supplementation with Juice Plus+ will significantly improve treatment          outcomes over placebo supplementation, at 3-months post-therapy, when used as an adjunct          to conventional non-surgical periodontal therapy.        2. Triple therapy with Juice Plus+ (fruit, vegetable & berry) will produce additional          treatment benefit over dual therapy (fruit & vegetable) and over placebo.        3. Improved treatment outcomes with Juice Plus+ will be maintained at 9-months          post-therapy.      Brief Summary:      Periodontal diseases are highly prevalent chronic inflammatory diseases and a major cause of     tooth loss. Data supports an association between periodontitis prevalence and reduced serum     levels of antioxidants. Anecdotal reports from periodontal specialists indicate significant     improvements in clinical outcomes from periodontal therapy where adjunctive Juice Plus+ is     used, in agreement with research data from other systemic diseases where hyper-inflammation     is implicated in disease pathogenesis. There is however, a lack of scientific evidence from     clinical trials of periodontitis. Given the demonstrable antioxidant deficiency in     periodontitis patients (both locally and peripherally), the excess oxidative stress in     periodontitis patients, and the anecdotal evidence of clinical benefit from the adjunctive     use of Juice Plus+, this study proposes to investigate the impact of daily supplementation     with Juice Plus+ as an adjunct to traditional non-surgical periodontal therapy, in improving     therapeutic outcomes.   "
236408|NCT00952549|"     The primary objective of this study is to determine the efficacy of a facial yoga exercise     program on appearance and to measure patient satisfaction with facial yoga practice.   "
236409|NCT00952562|"     A randomized placebo controlled trial evaluating the effect of the recently recommended high     doses of cholecalciferol (3000 IU/day) on mineral metabolism, blood pressure and pulse wave     analysis in healthy individuals.   "
236410|NCT00952575|"     This phase II study is designed to demonstrate the ability of LFB-R593 to effectively     eliminate exogenously-administered RhD-positive red blood cells from the circulation of an     RhD-negative individual, thereby preventing RhD-alloimmunisation.   "
236411|NCT00952588|"     The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone     and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in     AML patients.   "
236412|NCT00952601|"     Pharmacotherapy has long been considered the primary approach for tic suppression in Tourette     syndrome (TS). Unfortunately, medications are often ineffective and frequently have     significant side-effects. This is a pilot therapeutic study using a dietary approach, the     modified Atkins diet (MAD). The goal of this study is to establish the safety, tolerability,     and efficacy of dietary therapy in patients with TS (proof of concept) and to determine     whether this intervention is worthy of evaluation in large-scale clinical trials. The     modified Atkins diet mimics the well established ketogenic diet, but in a less-restrictive     dietary manner. Dietary approaches using the MAD/ketogenic diet are currently under     investigation for neurological conditions other than epilepsy, including Alzheimer disease,     headaches, autism, narcolepsy, brain tumors, traumatic brain injury, Parkinson's disease, and     depression.   "
236413|NCT00952614|"     The purpose of this study is to determine whether a fluocinolone sustained drug delivery     implant is effective in the treatment of central retinal vein occlusion that has caused     persistent macular edema and decreased visual acuity.   "
236414|NCT00952627|"     The purpose of this study is to determine whether Pycnogenol, a natural pine bark extract, is     effective in modifying the age-dependent process of cardiac fibrosis and diastolic function     in aged hypertensive subjects.   "
236415|NCT00952640|"     Background:      Vitamin A is of utmost importance for health and survival of children. A recent series in The     Lancet on maternal and child health put vitamin A deficiency at the top of most important     micronutrient deficiencies, responsible for more than 600.000 child deaths/year worldwide.     Vitamin A status of mothers and infants is closely linked. Hence, a mother with vitamin A     deficiency cannot give enough vitamin A to her fetus to build stores during the last months     of pregnancy, and will also have insufficient amounts of vitamin A in her breast milk,     resulting in a high risk for vitamin A deficiency in her newborn infant. The World Health     Organization (WHO) has implemented several strategies to fight vitamin A deficiency in     mothers and children. One of these is to give women after delivery a high dose vitamin A     supplement, to improve vitamin A status of mother and, via breast milk, her infant.     Surprisingly however, several recent studies investigating the effect of a high dose vitamin     A supplement for mothers directly after birth found no effect on vitamin A status in infants     6 months of age. In contrast, earlier studies in Bangladesh and Indonesia, in which women     received a high dose vitamin A supplement somewhere in the first 6 weeks after delivery,     reported a large impact on vitamin A status in the infants at 6 mo of age. The WHO     recommendation on post-partum vitamin A supplementation was based on these earlier studies     from Bangladesh and Indonesia. The more recent studies suggest however that this intervention     is not effective, and that millions of women currently receive a high dose vitamin A     supplement without clear benefits for vitamin A status in either the women or their children.      The human body reacts to infection or injury with an inflammatory response, which kicks off     with the acute phase response. The acute phase response helps the body to fight the     infection. It is characterized by many altered physiological processes, including changed     availability of vitamins and minerals. Recently, we found that delivery in itself causes a     major acute phase response. We have formed the hypothesis that the acute phase response     initiated by delivery prevents the high dose vitamin A supplement given to the mother     directly after delivery from being absorbed and from being available for breast milk. If this     is true, the current WHO recommendation to give the vitamin A within the first 6 weeks     post-partum should be changed to giving the vitamin A 4 - 6 weeks post-partum instead, to     allow the acute phase response induced by delivery to fade.      Objective(s) and Hypothesis(es):      The main objective is to improve the effectiveness of the current WHO policy of vitamin A     supplementation after delivery to improve vitamin A status and health of mothers and their     infants.      Methodology:      In a randomized, placebo-controlled, double-blind trial, 400 women will receive a high dose     of vitamin A (200.000 IU) within 6 weeks of delivery, as recommended by WHO. Half of the     women will receive the vitamin A directly after delivery (within 3 days, current practice),     whereas the other women will receive the vitamin A 6 weeks after delivery. To guarantee     blinding, women will receive a placebo capsule if they are not receiving a vitamin A capsule.      Main outcomes will be maternal and infant vitamin A status 6 months post-partum and the     time-course of the acute phase response, to establish the optimal time after delivery for the     initiation of the vitamin A supplementation.      Secondary outcomes will be the morbidity of the infants during the first 6 months of life and     growth performance of the infants at 6 mo of age.      Potential Impact:      The results of this study will enable WHO to improve the effectiveness of the current WHO     recommendations concerning post-partum vitamin A supplementation. If our hypothesis is true,     postponing the timing of the post-partum vitamin A supplement from directly after delivery to     6 week post-partum, will significantly increased the availability of the supplement for the     mother. This will increase the vitamin A status of both mother and infant. Moreover, there     are several significant implications for global health policies, with important consequences     for infant survival worldwide by reducing morbidity and mortality from infectious diseases     during the first 6 months of life. Results of the study will also have important consequences     for other micronutrient health programs, such as vitamin A supplementation for children above     6 months of age and iron supplementation in areas with endemic malaria, as these are also     subject to the effects of the acute phase response   "
236416|NCT00952653|"     The main purpose of this study is to evaluate the effect of desvenlafaxine administered as     DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount     of drug in the body and the effect of the drug will also be evaluated.   "
236417|NCT00952666|"     Neurovascular bundle (NVB) contains capsular vessels to the prostate and cavernous nerves     that provides the macroscopic landmark used during nerve-sparing radical prostatectomy. The     preservation of NVB during radical prostatectomy improves postoperative recovery of potency     and continence. However, the visualization of the NVB during radical prostatectomy can be     challenging.      Recently, an attempt has been made to use a transrectal ultrasound (TRUS) imaging to     delineate the anatomy of the prostate gland and NVB during laparoscopic radical     prostatectomy. However, it is difficult to obtain a steady image of TRUS with an operator.     The investigators plan to perform a feasibility study to obtain TRUS imaging of the prostate     and NVB during robot-assisted laparoscopic radical prostatectomy (RALRP). The investigators     plan to use a robot-assisted TRUS probe holder to gently manipulate the probe to obtain     steady TRUS images that may aid in visualization and dissection of the NVB during RALRP.   "
236431|NCT00952861|"     It is not clear whether antibiotic therapy is needed in patients with mild to moderate     exacerbation of chronic obstructive lung disease. The aim of the study is to compare the     effect of 1 day of treatment with 6 days of treatment in patients who are admitted to     hospital and being clinical stable (as judged by their physician) 24 hours after     hospitalization   "
236418|NCT00952679|"     Breast cancer patients who diagnosed by core needle biopsy or excisional biopsy underwent CT     scan to locate the sentinel lymph node (SLN) before SLN biopsy (SLNB) at the same day of     surgery. When CT examination performed, those patients were in supine position, with the arms     stretched upward but bent at the elbow with the hands at the side of the cranium which     similar to the surgical position. After local anesthesia, 2mL of iopamidol was injected     subcutaneously to the peritumoral and peri-areolar areas followed by gentle massage for about     1 minute. Contiguous 2-mm-thick CT images that included the breast and axilla were obtained     prior to administration of the contrast agent. After 3D CT reconstruction, the SLN was     identified as the most inferiorly visible nodule in the axilla connected to the lymphatic     vessel on the CT imaging monitor. A professional intervention doctor punctured the defined     lymph node guided by the CT monitor using the Breast Lesion Localization Needles (interv).     The needle would stay in the patient's axilla until the surgery. All the lymph nodes     including the CT defined one and which marked by methylene blue dye or 99mTc-sulfur colloid     tracers were removed, which then would be tested by touch imprint cytology for the     intraoperative diagnosis. Patients who had positive SLN would receive axillary dissection.     The investigators evaluated the new method by comparing lymph nodes defined by CT and     traditional ways.   "
236419|NCT00952692|"     This is a phase I/II study to determine the safety and gain insight into the immune response     of the immunologic agent dHER2+AS15 ASCI when administered in combination with lapatinib.     This study is for patients with metastatic breast cancer (invasive breast cancer with stage     IV disease) that overexpresses HER2 and is resistant to trastuzumab (Herceptin).      The dHER2 + AS15 candidate Antigen-Specific Cancer Immunotherapeutic (ASCI) contains a     recombinant protein termed dHER2, which is a truncated version of the HER2 protein. HER2 is a     protein that is commonly overexpressed in breast cancer. This protein is combined with the     immunological adjuvant AS15 Adjuvant System from GSK (GlaxoSmithKline), which is a liposomal     formulation containing three immunostimulatory components.      Lapatinib is FDA approved for use in combination with capecitabine for the treatment of     subjects with advanced or metastatic breast cancer whose tumors overexpress HER2.   "
236420|NCT00952705|"     The purpose of this study was to show that quadrivalent live attenuated influenza vaccine     (Q/LAIV-BFS; MEDI8662) was at least as immunogenic as two different forms of the commercial     vaccine, FluMist, by comparing the strain-specific antibody levels in the blood.   "
236421|NCT00952718|"     The purpose of this study is to determine whether inspiratory muscle training could improve     and/or prevent the deterioration of inspiratory muscle strength, clinical cardiopulmonary     outcome, systemic immunologic responses and quality of life in patients with bronchiectasis.   "
236422|NCT00952731|"     This randomized phase II trial is studying 4-hydroxytamoxifen to see how well it works     compared with tamoxifen citrate in treating women with newly diagnosed ductal breast     carcinoma in situ. Estrogen can cause the growth of breast cancer cells. Hormone therapy     using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells.     It is not yet known whether topical tamoxifen causes less damage to normal tissue than     systemic tamoxifen in treating patients with ductal carcinoma in situ.   "
236423|NCT00952744|"     While troponin is not detectable until several hours after an Acute Myocardial Infarction     (AMI), copeptin is expected to be elevated very early after an AMI. A combination of both     markers for the diagnosis of AMI early after the event is therefore expected to be     advantageous.   "
236424|NCT00952757|"     Hyperprolactinaemia is a common side effect of some antipsychotics (APS), including some     atypicals. Clinical consequences of hyperprolactinaemia are broad including amenorrhea,     galactorrhea, tender breasts, gynecomastia and sexual dysfunction. Less known but also     present is the increased cardiovascular risk, specially in women, disorders of osteoporotic     type and a potential increased risk of breast and prostate cancer.      Despite this growing evidence, there are no consistent published data in order to adopt     evidence-based decisions that may be beneficial for the patient.      This naturalistic observational 6 months follow-up study on patients with APS-induced     hyperprolactinemia aims to obtain more information about the switching approach in cases of     hyperprolactinemia secondary to APS and to better establish the role of switching to     quetiapine (APS not related with the increase prolactin levels) in this problem.   "
236425|NCT00952770|"     The first event of the atherosclerotic plaque formation is the accumulation of the low     density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall.     After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and     recruitment of monocytes to the intima and media are the next steps. The thickening of     intima-media thickness (IMT) is resulted from these initial events. The IMT can be easily     measured by high-resolution ultrasonography in various arteries including carotid, brachial     and radial arteries. The increased carotid IMT can be used as a non-invasive independent     parameter indicating increased cardiovascular mortality. Some investigators reported     increased radial IMT is associated with increased early failure of the radiocephalic     arteriovenous fistula in the hemodialysis patients. Moreover, radial IMT is increased in     patients underwent radial artery intervention because of denudation injury of the radial     artery. Recently, the use of statin can halt the progression of the carotid IMT progression.     However, it is unknown that the use of statin can prevent the progression of radial IMT after     the transradial coronary intervention. The investigators want to evaluate the effect of     statins on the progression of the radial IMT after the transradial intervention.   "
236428|NCT00952822|"     The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic     factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water     for injection (SWFI) and compare with those of rAHF-PFM reconstituted in 5 mL of SWFI.   "
236429|NCT00952835|"     In this study will be consecutive enrolled children with asthma (classified according to GINA     guidelines) and rhinitis (classified by ARIA guidelines); the investigators will research     clinical personal and parental history regarding allergic diseases, exposition to passive     smoking and interpretate hematochemical parameters markers of atopy. Skin Prick Tests will be     performed. In this study the investigators will evaluate lung function parameters (spirometry     with bronchial reversibility test and exercise induced bronchoconstriction, oscillometry,     respiratory plethysmography, etc.), airway inflammatory indices such as exhaled nitric oxide     at different flows, exhaled and nasal temperature, nasal cytology.      The aim of the study will be to evaluate possible correlation between these different     parameters and clinical status of the patients.   "
236432|NCT00952874|"     The molecular mechanisms involved in squamous cell carcinoma of the anus (SCCA) are poorly     elucidated. HIV-positive and renal transplant patients are at high risk for developing SCCA,     indicating that immune suppression plays a facilitating role. The investigators previously     demonstrated that chromosomal instability (CIN) was more prevalent in SCCA of HIV-negative     than HIV-positive patients. Hence, the investigators postulate that microsatellite     instability (MSI), another molecular pathway, might be a feature of SCCA progression in the     HIV-positive population.      Study Aims:        1. to determine the prevalence of MSI in paraffin-embedded tumor specimen of 15 patients          from the Swiss HIV cohort who underwent surgical excision for SCCA; and        2. eventually, to test our hypothesis by assessing the MSI status of SCCA in 15 recently          operated HIV-negative patients.      Study Design:      The study is designed in two steps:        1. Firstly, the investigators will retrieve tumor specimen from 15 HIV-positive patients,          with a biopsy-confirmed diagnosis of SCCA, in three institutions. DNA from tumor and          normal tissues will be extracted, and then amplified by PCR. Presence of MSI in tumors          will be determined by assessing the microsatellite markers BAT25, BAT26, and CAT25.        2. Secondly, the results of molecular analysis will be compared with a population of          HIV-negative patients, with the same tumors, using the same detection technique for MSI.   "
236433|NCT00952887|"     The purpose of this study is to establish safe dose levels of ACE-031 in healthy     postmenopausal women following multiple dose administration. This study will also evaluate if     ACE-031 has an effect on muscle.   "
236434|NCT00952900|"     With the great economic costs and traditionally poor outcomes among chronic temporomandibular     joint and muscle disorder (TMJMD) patients, it has become important to treat patients in the     acute state, in order to prevent these more chronic disability problems. This has been the     goal of two past funded grant projects. Results of the initial project isolated risk factors     that successfully predicted the development of chronicity with a 91% accuracy rate. A     statistical algorithm was developed which was used in the second project to screen out     high-risk patients. These patients were then randomly assigned an early intervention or     non-intervention group. One-year follow-up evaluations documented the treatment efficacy and     cost effectiveness of early intervention. These results have major implications for effective     early intervention and significant health care cost savings for this prevalent pain and     disability problem. For the present proposed project, we plan to implement this treatment     program in order to evaluate its effectiveness in more community-based dental practices. This     is in response to NIH's request for the implementation of evidence-based treatment     approaches, developed in controlled clinical settings, to the real world of diverse     practices in the community. Acute TMJMD patients will be recruited from two community-based     clinics. Based upon our risk screening algorithm, high-risk patients will be randomly     assigned to one of two groups (n=225/group): an early biobehavioral intervention or an     attention-control group. It is hypothesized that the attention control high-risk patients     will display more chronic TMJMD problems, relative to the high-risk early intervention     patients, at one- and two-year follow-ups. A number of biopsychosocial measures will be     evaluated, including chewing performance, the RDC/TMD, self-reported pain and stress, etc.     Such a multi-level, multi-systems approach has not been applied to better understand the     biopsychosocial underpinnings of TMJMD. Results from this component of the project will     greatly aid in stimulating future research leading to the better understanding of TMJMD, as     well as better tailoring of prescribed treatment regimens.   "
236435|NCT00952913|"     The purpose of this study is to see if there is an effect on the pharmacokinetics of     bosutinib when administered with lansoprazole.   "
236436|NCT00952926|"     The purpose of this study is to investigate if operation and permanent stoma can be omitted     in patients with cancer in the lower part of the rectum.   "
236437|NCT00952939|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This clinical trial is studying tumor samples in patients undergoing surgery or     radiation therapy for primary melanoma of the eye.   "
236438|NCT00952952|"     Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Pregnant or     nursing females are excluded. They can't have other untreated diarrheal conditions. Subjects     will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects     will be monitored weekly. A pathologist will review pre and post treatment biopsies. Subjects     that show improvement will be followed for 4 weeks post medication.   "
236439|NCT00952965|"     The purpose of this study is to monitor the blood pressure level of the patient using a wrist     cuff ranged 14 cm-25 cm.   "
236440|NCT00952978|"     Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a     randomized, double-blind, parallel and positive-controlled trial. They were randomly assigned     into two groups, 10 mg/day ilaprazole and 20 mg/day omeprazole, to be treated for up to four     weeks and be seen at week 1, 2 and 4. The primary endpoint was the ulcer healing rate at week     4. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms     relief was evaluated as secondary end points by using a graded score. Safety and tolerability     were evaluated on basis of clinical assessments.   "
236441|NCT00952991|"     Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to     enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In     addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric     accommodation. These characteristics make GLP-1 an ideal therapy for type 2 diabetes (T2D).     However, because of its rapid breakdown by dipeptidylpeptidase IV (DPP IV), GLP-1 has to be     administered by continuous intravenous infusion. This would be a drawback in clinical usage.     LAF237 is a synthetic inhibitor of DPP IV which has been shown to raise GLP-1 levels and     potentiate meal-induced insulin secretion and glucagon suppression. However, the effects of     LAF237 on gastric emptying and satiety are at present unknown. The investigators propose to     study the effects of LAF237 on gastric emptying, gastric volume and satiety in patients with     T2D in addition to examining the direct and indirect (mediated via insulin and glucagon) of     this compound on postprandial glucose metabolism.   "
236442|NCT00953004|"     The aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat     and energy digestibility in young adults.   "
236443|NCT00953017|"     Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to     colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel     cleansing regimen in adults and to determine the benefit of adding a pretreatment medication     to this bowel preparation. The tolerability of Miralax will hopefully improve patient     satisfaction with colonoscopy and decrease their reluctance to be screened because of the     uncomfortable taste and side effects of bowel preparation regimens.   "
236450|NCT00953134|"     The investigators hypothesize that periconceptional iron supplementation to married,     nulliparous women in rural Bangladesh will significantly reduce anemia and improve hemoglobin     concentrations before and during pregnancy.   "
236444|NCT00953030|"     This project tests the cost-effectiveness of two promising evidence-based health promotion/     behavior change interventions. The first intervention is the COACH Program, a revised version     of the Health Enhancement Program (HEP) that has been implemented to date with older adults     at multiple Senior Centers across the country (Leveille et al, 1998). The second is the     web-based RealAge program which is also being implemented for older adults at multiple sites     nationally and internationally. The Coach program combines a web-based risk assessment with     individualized counselling. In contrast, RealAge is a totally web-based program.      The specific hypotheses that we will test in the proposed cost-effectiveness study are shown     below.      Primary Study Hypotheses:      COACH participants will experience significantly greater reductions in absenteeism,     disability days, and healthcare use and cost at 6 and 12 months than RealAge participants.     Participants in both the COACH and RealAge treatment groups will experience significantly     greater reductions in absenteeism, disability days, and healthcare use and cost than control     group participants at 6 and 12 months.      Secondary Study Hypotheses:      COACH participants will experience significantly greater levels of adherence to health     promotion Action Plans and greater reduction in weight, body mass index, blood pressure and     depression and greater increase in vitality and quality of life than RealAge participants at     6 and 12 months. Participants in both the COACH and RealAge treatment arms will experience     significantly better outcomes on these measures at 6 and 12 months than control group     participants.   "
236445|NCT00953043|"     This study is being done to evaluate the effects of lubiprostone, a drug approved and used     for constipation, on pattern of contractions of the colon and the colon's sensitivity to     distension.   "
236446|NCT00953056|"     This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese     populations. Approximately 144 participants will be enrolled and equally stratified into     three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages     6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted     sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then     participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator     and the Ethics Review Committee will review blinded safety data and make decision based on     their best clinical judgment to move study forward between cohorts. Duration for the entire     study will be approximately 6-9 months.   "
236447|NCT00953095|"     The goal of this project is to test an intervention program for caregivers and their young     children with autism that is focused on improving social communication. This study     specifically targets underserved populations, specifically children from low SES and     racial/ethnic minority families. Participants will include 40 children (aged 24 months to 60     months) and their caregivers who will be randomized (as if by flipping a coin) to one of the     two treatments: Parent education sessions for two hours a week for 12 weeks or parent-child     intervention sessions with the child for one hour, twice a week for 12 weeks. Young children     with autism have difficulty with engaging in joint attention with others (e.g. pointing,     showing. Joint attention skills are important to later development of language. Therefore,     targeting this problem in young children may result in better language outcomes for these     children.      In order to examine the effects of the interventions, all participants will be complete     cognitive, language, communication and play-based assessments prior to treatment, at the end     of the first 12 weeks of the intervention, and post-treatment immediately following the     intervention (approximately 2.5 to 3 hours each).   "
236463|NCT00953316|"     This research study has been developed to obtain preliminary information about safe timing of     the transition of infants from car beds to car seats, and to find out if initial failure of     the car seat challenge is associated with small jaw size or increased respiratory illness.   "
236464|NCT00953329|"     Study Status:      Duke University Health System Institutional Review Board has received notification of study     termination; final IRB closure date is 12/12/2008. Study enrollment is now closed.      Enrollment Update:      Only one subject was entered into this study out of an expected enrollment of 15 patients in     this single site clinical trial. With no recruitment interest, the financial sponsor and     Sponsor-PI chose to close the clinical trial.   "
236475|NCT00953472|"     The investigators working hypothesis is that human hypertension is in part due to a     derangement in the endocrine function of the heart - a primary or secondary mechanism -     resulting in a relative deficiency of the natriuretic peptides (NP). The remodeled     hypertensive heart could result in altered processing and degradation of B-type NP resulting     in altered molecular forms with decreased biological activity. The investigators further     hypothesized the chronic administration of BNP in subjects with hypertension, is feasible,     safe and will induce a sustained reduction in blood pressure.   "
236448|NCT00953108|"     In former studies of the investigators research group the investigators could also     demonstrate acute inhibitory effects of the antidepressant mirtazapine on ACTH and cortisol     release in normal controls (Schüle et al. 2002), most likely mediated via antagonism at     central 5-HT2- and H1-receptors. In contrast to mirtazapine, serotonin or norepinephrine     reuptake inhibiting antidepressants acutely stimulate ACTH and cortisol secretion (Schüle     2007). The investigators also performed a study in depressed patients who were treated either     with mirtazapine or with reboxetine using serial dexamethasone/CRH tests (week 0, 1, and 5)     as a parameter for HPA axis activity. Mirtazapine, but not the norepinephrine reuptake     inhibitor reboxetine was able to significantly reduce HPA axis activity already within one     week (Schüle et al. 2006). Mirtazapine is known to have an earlier onset of antidepressant     action than do SSRIs such as sertraline (Behnke et al. 2003) or antidepressants with dual     mechanism of action such as venlafaxine (Benkert et al. 2006), possibly due to its rapid     inhibition of HPA axis activity in unipolar depressed patients.      Since mirtazapine and quetiapine have similar effects on the HPA system in healthy male     volunteers (i.e. inhibition of ACTH and cortisol secretion), a rapid attenuation of HPA axis     activity is also expected during quetiapine XR treatment in depressed patients.      Therefore, in the present study the investigators goal is to investigate whether quetiapine     fumarate XR at a dosage of 300 mg per day has an impact on HPA axis activity in unipolar     depressed patients, as measured by serial dexamethasone/CRH tests (week 0, 1, and 5) and     salivary cortisol profiles and whether putative effects of quetiapine XR on the HPA system     are related to its antidepressant efficacy.   "
236449|NCT00953121|"     The purpose of this study is to determine whether Bevacizumab, CPT-11 and Carboplatin in     combination are effective in the treatment of recurrent malignant glioma.   "
236456|NCT00953212|"     Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring     in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart     valve repair/replacement patients. Efforts to decrease the high rates of AF have not made     great inroads to the problem. The current standard of care is the use of preoperative and     postoperative beta blockers. We propose to compare the use of prophylactic oral ascorbic acid     with and without prophylactic oral amiodarone, in combination with oral beta blockers, for     the prevention of atrial fibrillation after open heart surgery. The hypothesis is that either     drug, or a combination of the two drugs, will be superior and safe when compared to beta     blockers alone.   "
236457|NCT00953225|"     Vitamin D promotes the differentiation of prostate cancer cells, maintains the differentiated     phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising     the possibility that vitamin D deficiency over time promotes the progression of subclinical     prostate cancer to clinical disease. The investigators propose to conduct a clinical study     aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans     diagnosed with low-risk, early-stage prostate cancer, who elect to have their disease     monitored through active surveillance. The successful completion of this proposed clinical     study will allow us to determine whether correcting vitamin D deficiency in Veterans     diagnosed with early-stage prostate cancer will prevent progression of their disease and     improve their prognosis.   "
236458|NCT00953251|"     BACKGROUND: We sought to determine the diagnostic value of the new TnThs assay for early     detection of evolving non-STEMI in patients with acute coronary syndrome and a negative 4th     generation cTnT result on admission.      METHODS: We evaluated several statistical patterns of blood results of TnT hs and cTnT of 115     patients and calculated necessity of prediction of evolving non-STEMI within 6 hours.      RESULTS: Based on the results of the 4th generation cTnT assay, an evolving non-STEMI was     diagnosed in 26 patients, 31 were classified as unstable angina. The TnThs lead to an     increase of non-STEMI diagnosis as compared to the 4th generation assay. We could calculate     increased sensitivities for earlier detection of evolving non-STEMI from 61.5% on admission     to 90.9% within 3 hours and 100% within 6 hours compared to cTnT.      CONCLUSIONS: The TnThs assay enables earlier detection of non-STEMI and allows identification     of an additional percentage of cases with non-STEMI previously classified as unstable angina.   "
236459|NCT00953264|"     The investigators here propose to evaluate the hormonal and metabolic effects of weight loss,     including evaluation of changes in several tissues.   "
236460|NCT00953277|"     The purpose of this study is to determine if it is technically feasable to repair nerves that     are injured as part of a planned surgical removal of the prostate and the surrounding tissue     in subjects with prostate cancer. The study will also examine the long term outcomes on     erectile function, continence and overall quality of life in the enrolled subjects.   "
236461|NCT00953290|"     The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new     indication of reduction of thigh circumference.   "
236462|NCT00953303|"     Evidence showed that glucocorticoids could induce potent diuretic actions and improve renal     functions in patients with decompensated congestive heart failure. Thus we design this study     to determine the efficacy of glucocorticoids on cardiovascular mortality in the 30 days     following randomization.   "
236465|NCT00953342|"     Asthma is a chronic disorder of the airways primarily driven by increased airway     inflammation, and is an escalating medical problem in Canada. For example, between 1994 and     2001 there was a 40% increase in the number of Canadians who had asthma. Not only is the     prevalence of asthma increasing but there has been a rapid rise in the number of asthma     events and costs associated with asthma and poor asthma control. It has been estimated that     the global cost of caring for asthma exceeds that of AIDS/HIV and tuberculosis combined.     These increases have occurred in spite of the development of clear asthma management     guidelines. There is evidence to suggest that aerobic exercise, e.g., running or cycling, may     improve asthma symptoms and control in children. However, there are currently no studies that     have systematically assessed the effects of exercise on asthma control or symptoms in adults.     The current proposed study will assess the effects of aerobic exercise in sedentary patients     with poorly controlled asthma. In addition to usual medical care, 52 patients will     participate in a supervised aerobic exercise program. The program will consist of 3 X 1hr     sessions of supervised exercise per week for 12 weeks. Another 52 patients will only maintain     usual medical care. The asthma control, quality of life, and inflammatory profile will be     evaluated at baseline and following the 12 weeks of treatment. The investigators believe     that: (1) The exercise intervention will significant improve asthma control and asthma     quality of life; (2) The exercise intervention will result in significant improvements in     inflammatory profiles; and (3) These changes in the inflammatory profile will be directly     related to the improvements in asthma control and quality of life.   "
236466|NCT00953355|"     Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves     hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and     intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin     B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus     patients treated with metformin.      Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if     folate supplementation may improve endothelial structure and function in PCOS patients.   "
236467|NCT00953368|"     The aim of this study is to evaluate the effects of remote ischemic preconditioning on     cognitive function in patients undergoing off-pump coronary artery bypass graft.   "
236468|NCT00953381|"     Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a     randomized, double-blind, parallel and dose-ranging trial. They were randomly assigned into     four groups to be treated for up to four weeks and be seen at week 1, 2 and 4: three of     ilaprazole, 5, 10, and 20 mg/day, and one of omeprazole 20 mg/day as positive control. The     primary endpoint was the ulcer healing rate at week 4. Healing of ulcer was determined by its     resolution from active to scarring stage. Symptoms relief was evaluated as secondary end     points by using a graded score. Safety and tolerability were evaluated on basis of clinical     assessments.   "
236628|NCT00945139|"     The purpose of this research study is to test the safety, tolerability, and effectiveness of     two chemotherapy drugs, pegylated liposomal doxorubicin (Doxil) and bevacizumab (Avastin).     How Doxil is metabolized and excreted from the body will also be studied.   "
236469|NCT00953394|"     Well differentiated neuroendocrine carcinomas have low proliferative activity and     conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent     administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic properties.     Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing     metronomic chemotherapy in this clinical setting.      A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU)     infusion plus long-acting release (LAR) octreotide for patients with neuroendocrine     carcinoma.   "
236470|NCT00953407|"     The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic     contact lens wearers when fit with one of 5 different daily disposable contact lenses.   "
236471|NCT00953420|"     Patients have a type of cancer called nasopharyngeal carcinoma (NPC) that has either come     back or not gone away after the best known standard treatments.      Most patients that respond to chemotherapy once their NPC tumors have come back have been     treated with a platinum-based medication like cisplatin. However, since many patients are     given cisplatin during their initial treatment for NPC, in this study, they will be treated     with another platinum-based chemotherapy medicine that has been used in patients with NPC     called carboplatin. In this study, carboplatin will be used in combination with another drug     called docetaxel. Other studies in patients with advanced head and neck cancer have shown     that docetaxel can cause tumors to respond better and allow patients to survive longer when     added to the standard treatments for those diseases.      Some patients with NPC show evidence of infection with the virus that causes infectious     mononucleosis, known as the Epstein Barr virus (EBV), before or at the time of their cancer     diagnosis. EBV is found in the cancer cells of almost all patients with advanced stage     disease, suggesting that it may play a role in causing NPC. Previously, patients have been     treated with high-risk NPC using EBV-specific cytotoxic T cells. These cells are grown in the     laboratory and taught to recognize and attack EBV infected cells. In the past, patients were     either given the cells alone or just after they had received a medication to briefly lower     their white blood cell count. In both cases, many patients had their tumors shrink and in     some cases completely disappear after being treated with these EBV-specific cytotoxic T     cells.      Investigators have now decided to look at how patients with NPC and their tumors respond to     the treatment combination of chemotherapy and EBV-CTL. Patients are being asked to     participate in this study since the NPC tumor is associated with EBV and has either come back     or not responded to standard treatment. This combination of chemotherapy and EBV-CTLs is an     investigational treatment not approved by the Food and Drug Administration.      The purpose of this study is to see how relapsed or refractory, EBV-associated NPC tumors     respond when treated with carboplatin and docetaxel followed by EBV-CTL.   "
236472|NCT00953433|"     This study is aimed at reducing the risk of hoarseness and damage to the vocal cords     following general anaesthesia. Conventional endotracheal intubation with use of a stylet will     be compared with the Endoflex tube. A conventional stylet enforced endotracheal tube is     dirigible because of the stiffness gained by the addition of a stylet. In high risk rapid     sequence intubation settings the enhanced dirigibility can be crucial, which is why most     anaesthesiologists choose to add the stylet in these situations. A new endotracheal tube with     a dynamic dirigible end called the Endoflex tube might prove to be a good alternative to the     conventional stylet enforced endotracheal tube.      Study hypothesis: The Endoflex tube will reduce the risk of hoarseness after intubation when     compared to the conventional stylet enforced endotracheal tube under optimal intubation     conditions.   "
236473|NCT00953446|"     The purpose of this study is to assess magnetic resonance imaging (MRI) as a tool to track     tumor growth for renal cell carcinoma while participants are on clinical treatment therapy of     sunitinib and AMG386. An MRI is a type of scan that uses powerful magnets to make clearer     images or to focus on detailed medical information in the abdomen and pelvis. The imaging     done for this study will use the arterial spin labeling (ASL) MRI technique that allows us to     see blood flow changes which possibly may indicate changes in tumor growth. Participants will     be on a clinical trial for the treatment.   "
236474|NCT00953459|"     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients     with small cell lung cancer.   "
236476|NCT00953485|"     This study will explore safety and efficacy of allogeneic mesenchymal stem cells     transplantation (MSCT) to treat patients with diagnosis of primary Sjögren's Syndrome (pSS)     who have been resistant to multiple standard treatments. The underlying hypothesis is that     the pSS condition is caused by an abnormal immune homeostasis that can be restored by MSCT.   "
236477|NCT00953498|"     HDL from patients with type 2 diabetes show a significant reduction of their     endothelium-dependent vasodilatory effect.      The primary objective of the study is to analyze whether treatment with glitazones     (pioglitazone and rosiglitazone)may improve the endothelium-dependent vasodilatory effect of     HDL lipoproteins in patients with type 2 diabetes.      The secondary objectives are:        -  to analyze the effect of glitazone treatment on phospholipase A2        -  to look for possible differences between the effects of pioglitazone and those of          rosiglitazone        -  to analyze the glycemic response to glitazone therapy according to clinical and          biological baseline characteristics.   "
236478|NCT00953511|"     RATIONALE: The prognosis of patients with advanced esophageal cancer may be improved by     preoperative chemoradiation. But only those patients have a benefit from this additional     therapy, whose tumor shows a response after chemoradiation. Molecular markers may help to     identify before starting the therapy those patients who response.      PURPOSE: This is the first prospective, clinical trial to study the impact of ERCC1 to     predict histopathological response to neoadjuvant radiochemotherapy (RTx/CTx) in patients     with cancer of the esophagus.   "
236479|NCT00953524|"     The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic     vaccine.      Primary Objectives:        -  To describe the immunogenicity of the candidate vaccines after each injection.        -  To describe the safety of the candidate vaccines after each injection.   "
236480|NCT00953537|"     RATIONALE: Identifying genes that increase a person's susceptibility to side effects caused     by capecitabine may help doctors plan better treatment.      PURPOSE: This clinical trial is studying blood samples in predicting response to capecitabine     in women with metastatic breast cancer.   "
236496|NCT00953745|"     Aripiprazole has been approved by the FDA for augmenting ineffective/partially effective oral     antidepressant therapy in patients suffering from major depression. The mechanism by which     this augmentation is achieved is not known. This study has been designed to test the     hypothesis that the primary mechanism of action of aripiprazole antidepressant augmentation     through the dopaminergic pathway. Two positron emission tomography (PET) scan procedures and     a functional magnetic resonance imaging (MRI) scan will be used to test this hypothesis.   "
236497|NCT00953758|"     This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on     select hematologic malignancies.   "
236655|NCT00945490|"     This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the     treatment of BPH (benign prostatic hyperplasia) as compared to placebo.   "
236481|NCT00953550|"     Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs     of stomach content. It is typically used in acute settings that require acute surgery or in     prehospital settings, but also in specific risk patients requiring elective surgery. The     reason for conducting rapid sequence intubation is to minimize the risk of pulmonary     aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid     sequence intubation is a procedure with a high risk of complications in itself. The time     period from induction of anaesthesia to intubation is particularly risky, because the patient     is apneic. This study addresses this problem by investigating, how quickly spontaneous     respiration can be reestablished after a rapid sequence intubation when using     Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended     to establish a sample size for the full protocol.      Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter     when using Rocuronium/Sugammadex compared to Succinylcholine.   "
236482|NCT00953563|"     The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and     compare its performance with the standard of care, compression therapy alone for the     treatment of venous leg ulcers.   "
236483|NCT00953576|"     The purpose of this research study is to determine the safety of giving ketoconazole,     hydrocortisone and dutasteride (KHAD) with lapatinib. The investigators believe that there is     evidence in castrate resistant prostate cancer that two growth factor receptors (EGFr and Her     2 /neu )are increased in prostate cancer cells. Both these receptors are turned off by the     drug lapatinib. By adding lapatinib to this trial, the investigators hope that the     investigators can turn off the signaling from the receptors and therefore make the     participant's cancer more responsive to KHAD treatment.   "
236484|NCT00953589|"     The purpose of this 12-week study was to assess in subjects with chronic hepatitis C     (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the early virologic     response to the 480 ug dose level of Locteron™, dosed every 2 weeks, in comparison with 1.5     ug/kg PEG-Intron™ dosed weekly.   "
236485|NCT00953602|"     In this study the effects of genetically modified potatoes on the human metabolism will be     observed. Healthy volunteers receive for one week muffins, produced with starch from a     genetically modified potato or with a normal available starch, in a randomized trial.   "
236486|NCT00953615|"     The purpose of this study is to determine the safety and benefit of Thalidomide with primary     sclerosing cholangitis (PSC). This is a six month study.   "
236487|NCT00953628|"     The purpose of this study is to investigate any potential advantages of replacing human     chorionic gonadotropin (uhCG) with recombinant human chorionic gonadotropin (recHCG) for     final oocyte maturation with regard to Ovarian hyperstimulation syndrome     (OHSS)pathophysiology, endometrium receptivity and embryo quality and clinical pregnancy.   "
236488|NCT00953641|"     The purpose of this study is to determine whether using Misoprostol vaginally before an     office endometrial biopsy is performed, will make it easier, more successful and less painful     to do the procedure.      The investigators' hypothesis is that vaginal Misoprostol 12 hours prior to endometrial     biopsy will increase the ease of performing office endometrial biopsy by reducing the need to     use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle.   "
236489|NCT00953654|"     The purpose of this study is to compare the effects of 6 weeks of endurance or strength     training and a wait list comparison condition on symptoms of Generalized Anxiety Disorder     (GAD).   "
236490|NCT00953667|"     The purpose of this study is to determine genetic factors that affect responses to niacin     therapy and endotoxemia in healthy volunteers.   "
236491|NCT00953680|"     This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ)     combination tablet and coadministration of losartan and hydrochlorothiazide.   "
236506|NCT00953888|"     The purpose of this study is to determine how well tolerated and safe AZD5069 is at different     dose levels in healthy male and/or females. The study will also investigate how quickly     AZD5069 is absorbed into and cleared by the body.   "
236690|NCT00945958|"     The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter,     open label, non-randomized, uncontrolled, single group assignment, safety study of subjects     with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive     study medication for a period of 24-weeks.   "
236492|NCT00953693|"     Induced pluripotent stem cells (iPSCs) are adult cells that have been genetically     reprogrammed to an embryonic stem cell-like state by being forced to express genes and     factors important for maintaining the defining properties of embryonic stem cells. The     reprogramming of adult cells into embryonic stem (ES) cells enables the generation of     patient-specific stem cells and thus has enormous potential for the treatment and analysis of     degenerative diseases. In this project the investigators are going to induce pluripotent stem     cells from cell cultures from skin biopsies of patients. The iPS cells will be developed for     modeling diseases and drug discovery as well as basic research.   "
236493|NCT00953706|"     The purpose of this study was to evaluate the safety and efficacy of ivacaftor in     participants with cystic fibrosis (CF) who were aged 12 years or older and were homozygous     for the F508del-CF transmembrane conductance regulator (CFTR) mutation. Ivacaftor is a potent     and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR     protein. Potentiators are pharmacological agents that increase the chloride ion transport     properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent     protein kinase A (PKA) activation.   "
236494|NCT00953719|"     This study is a supplement to the 28 mm Ceramic-on-Ceramic study which was designed to     evaluate artificial hips with a 28 mm ceramic head and liner to determine whether they     perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.      This arm of the study is designed to compare a 36 mm ceramic head and sleeve with a subset of     the control (28mm ceramic head and a polyethylene sleeve) from the original study (G030075)     (NCT#00208507) with additional follow-up, to determine if they perform as well.   "
236495|NCT00953732|"     This study is designed to follow up patients who have achieved complete clearance of AK     lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12     month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety     in the selected treatment area.   "
236500|NCT00953797|"     High Blood Pressure or Hypertension is one of the main causes of stroke, heart disease, heart     attack and kidney disease. Traditionally physicians use diet and lifestyles change and     medications to control patient's blood pressure. There are however, some patients whose blood     pressures are difficult to control and their blood pressure remains elevated despite multiple     medications. When blood pressure remains above goal (greater then 140/90 or greater then     130/80 mmHg in patients with diabetes or kidney disease) despite 3 or more blood pressure     medications, the investigators call it Resistant Hypertension.      Enhanced External Counterpulsation (EECP) is a new method of treatment currently used in     people with heart disease and chest pain. EECP therapy uses three sets of balloon like cuffs     that are wrapped to the calves, lower thighs, and upper thighs. These cuffs inflate and     deflate with every heart beat, causing increased blood return to the heart and better blood     flow. It has also been found to improve the function of endothelial cells, a type of cells     that lines the wall of blood vessel through out the body which helps to regulate and maintain     blood pressure. This leads us to believe that EECP therapy, although not used at present for     treating patients with Resistant Hypertension, may be useful in decreasing blood pressure.   "
236501|NCT00953810|"     The main aim of this randomized study was to evaluate the effect of educational intervention     on patients with heart failure and their care-giver with regard to patients' prognosis.   "
236502|NCT00953823|"     Patients with heart failure are at an increased risk for thiamin deficiency (TD), for many     reasons such as malnutrition and the use of diuretic drugs. Thiamin is a B vitamin that plays     an important role in the production of energy in body. Therefore, low levels of thiamin may     limit the amount of energy available for the heart to pump blood. Recent thiamin     supplementation trials have demonstrated significant improvements in heart function. However,     while clinically important, the results of these studies are limited by their small sample     sizes, indirect measurement of thiamin status and reliance on hospitalized patients.     Therefore, the investigators' goal is to determine the prevalence of thiamin deficiency in     ambulatory patients with heart failure by direct measurement of thiamin in red blood cells.   "
236503|NCT00953836|"     The purpose of this study is to investigate the kinetics of two known alkylresorcinol     metabolites in human subjects after intake of high-fiber rye bread. Whole grain rye is the     most abundant source of alkylresorcinols.   "
236504|NCT00953849|"     The poor survival of Veterans with oral cancer underscores the significance of identifying     new treatment approaches. The proposed studies will test a new 2 pronged immunotherapeutic     approach for oral cancer patients which lessen the immune inhibitory environment while     maturing cells that can stimulate T cell reactivity against oral cancer cells.   "
236505|NCT00953862|"     Although Attention Deficit/ Hyperactive Disorder (ADHD) is a common comorbidity in     individuals diagnosed with Substance Use Disorder (SUD), little data currently exists on the     utility of screening tools in large samples of adult patients with SUD in inpatient     treatment. This was a 10-week, 2-phase, open label trial of atomoxetine for ADHD in adult     patients being treated for a co-morbid SUD in a residential treatment facility (RTF). The     primary objective of the study was to assess the efficacy of atomoxetine in adults with an     SUD and ADHD. Secondary objects included assessment of the co-morbidity of ADHD and the     safety and tolerability of atomoxetine in this population.   "
236507|NCT00953901|"     Blood clotting abnormalities or problems that happen during surgery ? even minor surgery ?     are serious because of the possibility of serious bleeding that cannot be stopped. The     current standard practice for people with clotting abnormalities is to transfuse additional     blood before the surgery, in an effort to decrease bleeding problems. However, transfusing     blood before the surgery is not very effective in decreasing bleeding complications. In     addition, it may be associated with other complications, including fluid buildup and swelling     in the lungs. For this study, a person with a mild clotting problem is defined as one with an     INR (International Normalized Ratio) between 1.5 and 3. Severe clotting is defined as an INR     greater than 3. This study will aim to test if limiting or restricting transfusion for those     patients with severe clotting problems (an INR greater than 3) will result in fewer     transfusion problems and fewer unnecessary transfusions in comparison with the current, more     liberal, transfusion use for all patients with both mild and severe clotting problems (an INR     greater than 1.5).The investigators will also determine if liberal blood transfusion     decreases the risk of bleeding after surgical procedures.   "
236508|NCT00953914|"     The purpose of the study is to determine if pyridostigmine bromide improves heart rate     variability of type 2 diabetes mellitus subjects with cardiovascular autonomic neuropathy.   "
236509|NCT00953927|"     This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity     and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without     tuberculosis or HIV infection. This study planned to enroll 2784 infants (126 to 182 days of     age) who received study vaccine or control and were followed for 15 - 36 months. The study     was conducted at a single site in South Africa.   "
236510|NCT00953940|"     The purpose of this study is to measure the acute renal dysfunction on the first, second,     seventh and twentieth days.   "
236511|NCT00953953|"     Heart failure has become one of the major epidemics of the modern era. Despite optimal     standard drug therapy, the prognosis of patients with heart failure remains poor. Patient     with Heart Failure are prone to have dyssynchrony which means that there are electrical     disturbances that cause the heart to pump blood in an inefficient way. Ventricular     dyssynchrony has been associated with increased mortality in patients with heart failure.     Based on these observations, techniques have been developed to correct dyssynchrony. The     investigators propose to investigate the change of dyssynchrony in relation to intravascular     volume status and exercise in heart failure patients. The investigators also propose to     examine dyssynchrony in the setting of acutely decompensated heart failure. The change in     dyssynchrony will be followed to examine if it translates into clinical significance.   "
236512|NCT00953966|"     Starches from genetically modified potatoes, which differed in terms of amylose, amylopectin     and phosphate content, were tested in a human randomized controlled trial.   "
236656|NCT00945503|"     A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over     time for GSK1018921.   "
236516|NCT00954018|"     Scientist have begun to realize that many types of bacteria often live together as a complex     community, and the investigators wish to apply that idea to the bacteria in the respiratory     system of people with Cystic Fibrosis (CF). It is possible that the survival of the many     millions of bacteria in the CF lung depends on the production of special chemicals that might     be made only by very few types of bacteria. If that is true, medicines that interfere with     those chemicals could treat the lung infections that cause trouble for nearly all people with     CF. The investigators wish to study the production of several potentially critical chemicals     by the respiratory bacteria and to examine the effect of those chemicals on the makeup of the     entire community of bacteria. To detect all the bacteria in that community, the investigators     will use new methods that use bacterial genetic information and can detect hundreds of     different types of bacteria in respiratory samples of individual CF patients.   "
236517|NCT00954031|"     Analyze in children and adults, risk factors in the onset of the APA. The main hypothesis     focuses on the use of anti-inflammatory in the context of pharyngitis or sore throat before     the symptoms of ABS. Secondary objectives:        1. - Analyze the implementation of a rapid diagnostic test and its result on the occurrence          of an ABS        2. - Measure the frequency of prescription and describe the reasons for not prescribing an          antibiotic for patients who consulted for a sore throat and having developed a PLA        3. - Describe the microbial flora could puncture of patients hospitalized for APA   "
236518|NCT00954044|"     The purpose of this study is to explore the benefits of Exercising Together-a partnered     strength training program for married couples coping with prostate cancer- on the physical     and emotional health of prostate cancer survivors and their spouse and on marital quality.   "
236519|NCT00954057|"     This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.   "
236520|NCT00954070|"     This is an observational, prospective and pilot study to determine through confocal     endomicroscopy diagnostic microscopic features detectable at the gastroesophageal junction of     patients with non-erosive gastroesophageal reflux disease.      The hypothesis is that minimal mucosal changes occur in non-erosive gastroesophageal reflux     disease. Although these minimal changes are not always visible on white-light endoscopy, it     is detectable using high-resolution confocal endomicroscopy and these confocal features are     diagnostic of non-erosive reflux disease (NERD).   "
236521|NCT00954083|"     Thirty two children age 2-6 years are recruited into the study and the randomization will be     stratified for chronological age and symptom severity into 2 main groups, intervention and     control. The intervention group will receive an additional target treatment of DIR/Floortime     parent training intervention, while the control group will continue on their routine care for     3 months.      Hypothesis: Children in the intervention group show much improvement in climbing the     developmental ladder and declining in the autistic behaviors.   "
236522|NCT00954096|"     This study will address the hypothesis that nicotine, like cigarette smoking acting as a     pro-oxidant may have adverse effects on arterial function.   "
236523|NCT00954109|"     The overall aim of the project is to determine whether or not exercise influences     cardiovascular or nervous responses to meal ingestion in individuals with insulin resistance     or type 2 diabetes.   "
236524|NCT00954122|"     The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR)     tablets for 3 weeks will improve their agitation when they have acute psychosis.   "
236525|NCT00954135|"     Endocrine therapy is the mainstay of systemic treatment in patients with endocrine responsive     breast cancer. Aromatase inhibitors are the most active agents in post-menopausal women.     Randomized comparisons either in primary/adjuvant setting or in metastatic disease setting     have demonstrated the superiority of these drugs over tamoxifen.      Primary systemic treatment administered to breast cancer patients is a useful model to     identify baseline features able to predict which patients are most likely to benefit from     cytotoxic treatment and is a way to study new biological markers in relation to the     predictive information they provide.      This treatment modality represents therefore the best way to explore new treatment strategies     in particular treatment strategies involving target therapies.      We have conducted a randomised phase II trial in which the activity of Letrozole plus/minus     oral metronomic cyclophosphamide as primary systemic treatment has been investigated in a     patient population of elderly breast cancer patients. The conclusions were that the     combination of letrozole with metronomic cyclophosphamide was a very active scheme. In     addition this was the first study demonstrating in vivo the antiangiogenic effect of     metronomic scheduling. This study suggests that chemotherapy administered on a metronomic     schedule, targeting therefore the neo-angiogenesis, could be synergistic with endocrine     therapy with aromatase inhibitors.      Sorafenib is a multi-kinase inhibitor targeting Raf, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-alfa,     Flt-3, c-Kit, and p38.      There is a strong rationale of combining different anti-angiogenic agents. At the ASCO 2007     meeting the data of a phase I study exploring the toxicity of a combination of sorafenib and     bevacizumab have been presented. The results showed an increased toxicity being dose limiting     in some patients. To our knowledge there are no data un activity and toxicity of adding     sorafenib to metronomic chemotherapy.   "
236526|NCT00954148|"     This is a comparison, at this VA Hospital,of routine multi-visit and multi-testing for solid     tumor recurrence in four tumor groups to a limited scheduled 5 visit history/physical with     PET/CT only, over a five year period. The purpose is to show through utilization of the     single most sensitive and specific test currently available-PET/CT-that survival for patients     in follow-up can be improved.(Plus lowering medical costs and increasing patient confidence     and compliance with follow-up appointments).   "
236527|NCT00954161|"     The objective of this study is to measure the effect of an innovative training programme on     the help seeking behaviour and helping rates of bystanders in medical emergencies.   "
236528|NCT00954174|"     This randomized phase III trial studies paclitaxel and carboplatin see how well they work     compared with paclitaxel and ifosfamide in treating patients with fallopian tube, or     peritoneal cavity cancer that is newly diagnosed, persistent, or has come back (recurrent).     Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ifosfamide, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. It is not yet known whether     paclitaxel is more effective when given with carboplatin or ifosfamide in treating patients     with uterine, ovarian, fallopian tube, or peritoneal cavity cancer.   "
236566|NCT00954681|"     Marijuana is the most commonly used illicit drug in the United States. However, the treatment     options for cannabis dependence are limited; notably, no effective pharmacotherapy has been     developed. Conceptually, the ideal medication treatment for cannabis dependence would:        1. be safe when administered to patients actively using cannabis        2. reduce cannabis intake and promote abstinence        3. treat the symptoms of cannabis withdrawal        4. reduce craving and relapse risk        5. have a low abuse liability.   "
236529|NCT00954187|"     Purpose: To compare the efficacy of oral gabapentin and its newer analogue pregabalin in     postoperative pain control after photorefractive keratectomy (PRK).      Methods: One hundred and four patients who meet the inclusion criteria undergoing PRK in one     or both eyes will be randomized into one of two treatment groups. Those in group A will be     treated with gabapentin, and those in group B will be treated with pregabalin to control     postoperative PRK pain. Patients in both groups will begin treatment two hours prior to     surgery in order to achieve therapeutic blood levels of each medication. After surgery the     patients will assess their pain level using the visual analogue scale (VAS) at different     intervals of time - one hour after surgery, the evening of the surgery, and three times each     day for three subsequent days. Patients will also daily assess their level of somnolence     using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness for the same     amount of time. On the fourth day they will return to clinic for a postoperative appointment.     At that time the pain, sleepiness, and dizziness assessment scales will be collected and     analyzed. The patients will return one month later to further assess long-term pain and     healing after PRK.      Results: Both gabapentin and pregabalin have been shown in previous studies to treat     postoperative pain effectively. The effects of gabapentin 300 mg TID for 3 days versus     pregabalin 50 mg TID for 3 days on decreasing overall postoperative pain following PRK will     be presented.      Conclusion: The effectiveness of the two different treatment medications will be analyzed,     and the conclusion will be based on the results.   "
236530|NCT00954200|"     Scientific background: Bronchoscopy is a procedure commonly performed in the management of     persistent respiratory illness. In the last decades this exam has become a routine and safe     procedure even in children and there are few side-effects. However, one known side effect is     transient fever and even high fever a few hours after the bronchoscopy. This side effect is     not dangerous but very uncomfortable for the patients and it would be interesting to try to     reduce this phenomena. This fever is due to a release of cytokines during the     broncho-alveolar lavage procedure and not to sepsis. In a previous study a single dose of     dexamethasone was shown to prevent the fever post bronchoscopy with no apparent detriment to     the child. It is well known that steroids are immunosuppressive. Even though the     post-bronchoscopy fever is not caused by an infection, it seems preferable to use other     anti-inflammatory drugs to fight this very inconvenient side effect.      Ibuprofen (Nurofen*) is known as an effective medication to reduce fever in infectious     illnesses and is even considered as superior to paracetamol. It has no immunosuppressive     effect and is usually well tolerated by children with very few side effects when taken in the     normal therapeutic dose of 10mg/Kg. The investigators postulate that a dose of Nurofen prior     to bronchoscopy could significantly reduce fever post bronchoscopy.   "
236544|NCT00954395|"     The purpose of this study is to evaluate the efficacy and safety of a standardized procedure     to establish the optimal duration of anticoagulation in patients with venous thromboembolism.   "
236531|NCT00954213|"     Thirty eight autistic spectrum disorder children age 2-6 years recruited into the study. The     new treatment intervention is based on the DIR Model. Parents will be coached at the start     and then every 3-4 months for 1 year. Outcome will be measured at the first session and at     the end of the study using Functional Emotional Assessment Scale and Childhood Autism Rating     Scales, Functional Emotional Level, and parent satisfaction rating.      Hypothesis of the study: Children who get additional treatment of DIR/floortime show much     improvement in climbing the developmental ladder and declining in the autistic behaviors.   "
236532|NCT00954226|"     The goal of this clinical research study is to learn the effects of the standard dose of     erlotinib and the higher dose of erlotinib on biomarker levels in patients with head and neck     cancer. Biomarkers are chemical markers in the blood and/or tissue that may be related to     your response to the study drug. The safety of the drug will also be studied.      Objectives:      To determine the molecular effects and safety of erlotinib 150 mg/day (standard dose) and 200     mg/day or 300 mg/day (high-dose) in patients with head and neck cancer who are planned for     surgery.      Primary Objective:      To determine the effects of erlotinib 150 mg/day (standard dose) and 200 mg/day or 300 mg/day     (high-dose) on the phosphorylation of AKT protein downstream from EGFR.      Secondary Objectives:        1. To assess the safety and tolerability of erlotinib 150 mg/day (standard dose) and 200          mg/day or 300 mg/day (high-dose).        2. To correlate the effects of erlotinib on the phosphorylation of AKT with the          immunohistochemical expression level of EGFR and the level of amplification of the EGFR          gene as determined by fluorescent in situ hybridization (FISH).        3. To evaluate the preliminary response rate with a short course of erlotinib.        4. To evaluate changes in the activation status of proteins downstream from EGFR and other          receptor tyrosine kinases and in markers of epithelial to mesenchymal transition.        5. To evaluate changes in blood-based biomarkers.        6. To evaluate the effects of a higher dose of erlotinib (300 mg/day) in current smokers.   "
236533|NCT00954252|"     The purpose of this study is to evaluate the safety and tolerability of single oral doses of     CHF 5074 in young healthy male volunteers.   "
236534|NCT00954265|"     To access whether the ovulation triggering with rec-HCG instead urinary-HCG has any impact on     the blastulation rate and pregnancy rate of patients undergoing IVF treatment   "
236535|NCT00954278|"     The purpose of this study is to determine the number of patients with advanced, relapsed     non-small cell lung cancer who can tolerate dose escalation sorafenib from 400 mg twice daily     to either 600 mg twice daily or 800 mg twice daily. Safety and tolerability of sorafenib will     also be examined.   "
236536|NCT00954291|"     The objective of the study is to characterize the pharmacokinetic profile of granisetron     patch after single administration to healthy subjects.   "
236537|NCT00954304|"     The purposes of this study are to investigate the duration of P-glycoprotein inhibition after     oral administration of HM30181AK tablet in healthy male subject and proper dose of HM30181AK     tablet.   "
236538|NCT00954317|"     The investigators wish to compare the analgesia provided by epidurals placed high in the     lumbar spine versus epidurals place low in the lumbar spine.   "
236539|NCT00954330|"     The aim of this prospective randomized controlled trial was to compare the effectiveness of     surgical and conservative treatment in acute lateral ligament injury of ankle. The more     detailed aims were to assess the function, physical activity level, re-injuries, objective     stability and radiographic changes seen by magnetic resonance imaging in patients randomized     to surgery or to functional treatment after a mean of 14 years follow-up.   "
236540|NCT00954343|"     Extracorporeal Shock Wave treatment is a well established treatment in orthopedics.     Considerable success has been reported after treatment of various soft tissue pathologies     (Tendinitis, heel spur etc). In recent years, encouraging results have been reported     concerning the effect of the shock-wave on chronic wounds. It has been reported that healing     time can be considerably shortened if shock-waves are applied to the wound in addition to     conventional wound treatment. Yet, randomized, controlled, prospective trials are missing.      In this study, the effect of shock-waves on diabetic foot ulcer shall be assessed.      The study is composed of 5 groups of which 4 groups receive shock wave treatments (each with     a different protocol). One group serves as an untreated control group. All groups get     standardized wound treatment and wound dressing.      That shock-wave application protocol that shows the best results (rate of completely healed     ulcer, most decrease of ulcer size) shall be tested in a further, sufficiently dimensioned,     two-armed, randomized controlled trial (RCT).   "
236541|NCT00954356|"     The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain     following third-molar/wisdom tooth extraction.   "
236542|NCT00954369|"     PHASE: Phase 0, Exploratory Study      OBJECTIVES: To collect drug safety, bio-distribution and dosimetry data, to begin collection     of PET/CT imaging data, to acquire experience to improve study design and the conduct of     future studies.      DESIGN: Exploratory, open label, non-randomized, multi-center study.      DURATION: Three visits - one screening, one imaging, and one follow-up visit at 24 hours     post-dose      PROCEDURES: Informed consent, collection of demographic information and medical history,     administration of mental status exam, physical examination, vital signs, 12-lead ECGs,     routine blood tests to assess major organ functions, complete blood counts and clinical     chemistries for safety, dosing with [F-18]W372, PET imaging scans of brain (in sixteen     subjects), whole body PET imaging and urine collections for dosimetry evaluation (in four     subjects only), observation and interviews following imaging to collect adverse events.      SUBJECTS: Twenty (20) subjects ≥ 55 years old:      Group 1 will consist of 10 subjects who have a low probability of being currently positive     for Alzheimer's Disease (AD) as defined by the protocol criteria (MMSE ≥ 28). Four of the 10     subjects will undergo whole body PET imaging for dosimetry evaluations, and 6 of the 10     subjects will undergo PET imaging of the brain only.      Group 2 will consist of 10 subjects who have a high probability of currently being positive     for AD as defined by the protocol criteria (MMSE < 24); these 10 subjects will undergo PET     imaging of the brain only.   "
236543|NCT00954382|"     Previous foreign studies revealed that the IQ in Down syndrome (DS) declines with age, but     not any investigation of domestic data in Taiwan was available. Individuals with DS are     characterized by limited verbal development, and in this article, authors look into the     diverging verbal-nonverbal abilities in the DS phenotype.   "
236546|NCT00954421|"     The purpose of this research study is to:        1. Determine whether deep brain stimulation (DBS) with two leads (very thin coiled wires)          placed unilaterally (on one side of the brain) is beneficial to patients with multiple          sclerosis (MS) tremor.        2. Compare the two different locations of the DBS lead placement in effectiveness for          treatment of muscle tremors that do not respond to treatment with medication caused by          multiple sclerosis.        3. Evaluate any side effects that may result from the two DBS leads.   "
236547|NCT00954434|"     Fifty healthy human subjects are randomized to not to consume any alcohol at all or to drink     1 glass of red wine/day for women or 2 glasses for men for three months. Outcomes are changes     in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body     composition.   "
236548|NCT00954447|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and     longer) in combination with basal insulin in patients with type 2 diabetes mellitus with     insufficient glycaemic control.   "
236549|NCT00954460|"     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme     glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside     accumulates within macrophages leading to cellular engorgement, organomegaly, and organ     system dysfunction. The purpose of this treatment protocol is to observe the safety of     velaglucerase alfa in patients with type 1 Gaucher disease who are either treatment naive     (newly diagnosed) or who are currently being treated with the Enzyme Replacement Therapy     (ERT) imiglucerase.   "
236550|NCT00954473|"     This research trial studies blood samples from patients with osteosarcoma. Studying the genes     found in samples of blood from patients with osteosarcoma may help doctors identify     biomarkers related to the disease.   "
236551|NCT00954486|"     The primary objective of this study is to assess the ability of epoetin alfa to raise     hemoglobin (Hb) levels in elderly outpatients with unexplained anemia. The secondary     objectives of this study are to assess the ability of epoetin alfa to improve physical     function; cognitive function; and quality of life, and to assess the safety of epoetin alfa     in the study population.   "
236552|NCT00954499|"     The aim of this study is to answer the following question: In healthy infants aged four to     six months undergoing routine immunization for diphtheria, tetanus, acellular pertussis,     inactivated poliovirus and Haemophilus influenzae type B (DTaP-IPV-Hib) and pneumococcal     conjugate vaccine (PCV) while receiving a combination of proven analgesic interventions     (least painful injection technique, holding by parent, and oral sucrose solution) and     non-procedural talk by the parent, does the addition of rubbing near the site of injection     reduce pain as measured by the Modified Behavioral Pain Scale (MBPS) to a greater extent than     no rubbing?   "
236553|NCT00954512|"     This is a Phase 1B/2, non-randomized, dose-escalation, multicenter, open-label study designed     to evaluate the safety and tolerability of robatumumab (SCH 717454, MK-7454) in combination     with standard treatment in participants with advanced solid tumors to be conducted in     conformance with Good Clinical Practices.      Six different treatment regimens will be investigated in combination with robatumumab.      The study will be divided into two parts. Part 1 will consist of initial safety evaluation     and dose-finding of robatumumab in combination with each treatment regimen. Part 2 will     consist of an expansion of each robatumumab regimen at a newly established dose level, to     better define safety, tolerability, and initial efficacy in specific target populations.   "
236597|NCT00944736|"     The purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on     intestinal permeability in pediatric patients with Crohn's disease.   "
236554|NCT00954525|"     Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis     with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging     (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation     therapy. Full inclusion/exclusion criteria are available. History and physical examination,     and laboratory and imaging analyses will be done within 14 days prior to registration. The     three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid,     three times per week for 8 weeks. Subjects will also have co-administration of the     chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9     to 18 participants will be enrolled in this Phase I study.   "
236555|NCT00954538|"     This study will estimate the radiochemical and radiation safety and assess the efficacy of     [18F]MK-3328, a novel positron emission tomography (PET) tracer. The study safety hypotheses     will test whether [18F]MK-3328 is sufficiently safe and well-tolerated, based on an     assessment of clinical and laboratory evaluations and adverse experiences in healthy     participants, including healthy elderly (HE) participants, and Alzheimer's disease (AD)     participants, to permit continued investigation. The study efficacy hypothesis will test     whether [18F]MK-3328 can discriminate between AD participants and cognitively normal elderly     control participants based on tracer volume of distribution, or one of its surrogates, in     brain posterior cingulate gyrus.   "
236556|NCT00954551|"     Systemic inflammatory response syndrome (SIRS) is characterized by changes in body     temperature, heart rate, respiratory rate, or peripheral blood white cell count, and is often     a heralding manifestation of blood infection (ie., sepsis or bloodstream infection). SIRS     however can occur as a result of a stroke without sepsis. When SIRS occurs after stroke,     patients are subjected to blood cultures and tests to exclude sepsis, and are often     empirically treated with antibiotics potentially leading to a serious gastrointestinal     infection called C. difficile enterocolitis, and bacterial antibiotic resistance. Development     of a blood test that could provide sufficient sensitivity to exclude blood infection in     stroke would therefore prevent numerous tests, cultures, antibiotics, and costs. In recent     years, there has been increasing evidence that procalcitonin (PCT) may serve as diagnostic     marker to distinguish between infectious and non-infectious SIRS. The investigators     hypothesize that PCT can differentiate SIRS after stroke into patients with infection and     those without infection. Such screening tests would provide crucial information to clinicians     that could improve patient care by reducing the number of tests and antibiotics used, as well     as antibiotic-related infections, bacterial resistance and hospital costs.      Hypothesis: The investigators hypothesize that PCT can be used to define normal (SIRS without     infection) and abnormal values SIRS with infection (i.e., blood, lung, urinary, spinal fluid)     in a population of patients with aneurysmal subarachnoid hemorrhage (SAH).      Specific Aim 1.) To establish normal values of PCT in patients with aneurysmal subarachnoid     hemorrhage and SIRS.      Specific Aim 2.) Derive the sensitivity and positive predictive value of abnormal PCT values     in patients with aneurysmal SAH, SIRS with true systemic infection.   "
236557|NCT00954564|"     RATIONALE: Gathering information over time about joint pain and stiffness from postmenopausal     women with early-stage breast cancer who are receiving aromatase inhibitors may help doctors     plan treatment and help patients live more comfortably.      PURPOSE: This observational epidemiologic cohort is designed to study arthralgia,     patient-reported outcomes, and medication adherence in postmenopausal women with early-stage     breast cancer who are receiving aromatase inhibitors.   "
236558|NCT00954577|"     This study examines risk factors for type 2 diabetes in children representing multiple     discrete ethnic groups. It also examines the short term effects of school-based health     education supervised exercise on metabolic risk factors for type 2 diabetes mellitus in     children. The investigators hypothesize that exercise and health education will significantly     improve insulin sensitivity in all children, especially in children who are already insulin     resistant, thereby lowering the risk that they will go on to develop type 2 diabetes     mellitus. The specific hypotheses being tested are:        1. Insulin resistance will be most evident in overweight children while an impaired ability          of the pancreas to release insulin will be most evident in children with a family          history of type 2 diabetes mellitus.        2. Exercise will significantly improve insulin resistance (as measured by the fasting          glucose/insulin ratio) with little effect on insulin secretory capacity in children.        3. Participation in a school-based health, nutrition, and exercise education program will          have long term beneficial effects on health related behaviors and on insulin resistance          in all children, regardless of their level of diabetes risk.   "
236559|NCT00954590|"     The purpose of this study is to determine if Dimebon is safe and effective in patients with     moderate to severe Alzheimer's disease.   "
236560|NCT00954603|"     The purpose of this study is to determine whether quetiapine, and haloperidol are effective     and safe in the treatment psychiatric symptoms in patients with delirium.   "
236561|NCT00954616|"     In each of the 7 French areas that should be involved, patients aged 75 years and over from     three different sectors will be included: the geriatric consultation unit (60%) and two kinds     of nursing homes, private (20%) and state (10%). Outpatients will be included in     chronological order; patients in nursing homes will be included at random. The patients and     their families will be asked about the treatments received on the day of inclusion. The     inclusion period will extend over a year. The investigating practitioners will be asked to     fill in a questionnaire reporting the main clinical data, adverse effects occurrence, and     information on the treatment given.   "
236562|NCT00954629|"     The purpose of the study is to demonstrate the superiority of topically administered 2PX     versus placebo (vehicle) control in terms of reduction in pain intensity and physical     function.   "
236563|NCT00954642|"     This is a Phase Ib, open-label, dose-escalation study of MNRP1685A given by intravenous (IV)     infusion as therapy for locally advanced or metastatic solid tumors.   "
236564|NCT00954655|"     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer     may help doctors identify biomarkers related to cancer.      PURPOSE: This research study is looking at tumor samples in patients undergoing treatment for     gastrointestinal stromal tumors on clinical trial ACOSOG-Z9001.   "
236565|NCT00954668|"     Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany     per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The     currently available evidence led to current guideline recommendations that a systematic     approach of immediate angiography in NSTEMI patients stabilized with contemporary     antiplatelet treatment is not mandatory. However, this immediate invasive approach is     appealing because it allows treating the underlying cause (the plaque rupture) as early as     possible with subsequent reduction of death and recurrent myocardial infarction. In the IDEAL     NSTEMI trial we test an immediate invasive approach (<2 h) with an approach 12-72 h according     top guidelines with respect to 6 months death and mortality.   "
236567|NCT00954694|"     The purpose of this research study is to determine if participation in a fifteen week     introductory exercise regimen using the NuStep by sedentary adults diagnosed with Type 1 or     Type 2 diabetes will affect exercise adherence and lifestyle adjustment. This study will     examine if using the NuStep encourages participants to seek other modes and facilitates     interest in exercise. Age, gender, weight, height, waist-to-hip ratio, heart rate, blood     pressure, 6-minute walk test, and A1C will be recorded pre, mid-point, and post-test. During     each NuStep exercise session heart rate, blood pressure, blood glucose level, oxygen     saturation, METs, and the Borg rate of perceived exertion will be monitored.      Associations between NuStep use and exercise adherence are investigated through the following     hypothesis and null hypothesis. There is an association between using the NuStep as an     introductory exercise regimen by sedentary adults diagnosed with Type 1 or Type 2 diabetes     and exercise adherence. The null hypothesis states there is no association between using the     NuStep as an introductory exercise regimen by sedentary adults diagnosed with Type 1 or Type     2 diabetes and exercise adherence. The primary endpoint of the study is the qualitative     measurement, by use of a questionnaire, of attitude and interest toward exercise in     participants by assessing if they choose to seek and perform other modes of exercise.     Secondary endpoints are the quantitative measurement of the change in weight, waist-to-hip     ratio, heart rate, blood pressure, 6-minute walk test, and A1C levels.   "
236568|NCT00954707|"     CYPRESS: A Prospective,Randomized,Multi-Center,Double-Blind Trial to Assess the Effectiveness     and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing     Percutaneous Coronary Intervention with the CYPHER® Sirolimus-eluting Coronary Stent (CYPHER®     Stent)   "
236569|NCT00954720|"     Recent retrospective studies have suggested that iron overload is a clinically important     problem in patients undergoing ablative stem cell transplantation. However, these studies     relied on serum ferritin as a surrogate of iron overload, which limits the conclusions that     can be drawn from such analyses. Therefore, the investigators are conducting a prospective     study to more rigorously examine the prevalence, mechanisms, and consequences of iron     overload in this patient population.   "
236570|NCT00954733|"     The estimation of the partial pressure of carbon dioxide (PCO2) in the arterial blood is used     to judge the adequacy of ventilation during spontaneous and controlled ventilation. Although     the gold standard for monitoring PCO2 remains arterial blood gas sampling, this requires an     invasive procedure and provides only an intermittent estimate of what is frequently a     continuously changing value. The solution to this problem has been the development and     validation of accurate noninvasive monitoring techniques which provide a continuous     intraoperative estimate of PCO2.The most commonly used noninvasive technique to monitor PCO2     is measurement of the end tidal CO2 (PECO2) . However, sampling errors and patient -related     issues such as ventilation-perfusion mismatch, patient positioning or decreases in pulmonary     blood flow may influence the accuracy of PECO2 monitoring (1-3). Nasal capnography has been     proved to be an accurate monitor during the post-operative period (4) but its ability to     accurately detect hypoventilation associated with deep sedation has not been studied.      According to the American Society of Anesthesiologist standards for basic monitoring,     continuous capnography is required for all patients undergoing general anesthesia but it is     optional for MAC/sedation cases. The need for CO2 monitoring has been studied by other     medical specialties that use procedural sedation, including gastroenterology (12) and     emergency medicine (13, 14) and many specialties now recommend capnography as a standard     monitor.      Patients receiving supplemental oxygen may experience significant persistent hypoventilation     leading to progressive hypercarbia and acidosis which may go undetected for a significant     time interval since the routinely monitored SpO2 may be maintained within normal range. A     recent study has shown that despite the fact that end tidal CO2 is reliable in detecting     apnea , increasing oxygen flow rates decrease the amplitude of measured CO2, probably via     dilution, making the quantitative value less reliable as an assessment of adequacy of     ventilation (15). Furthermore, during hypoventilation there is reduced alveolar ventilation     and the end tidal CO2 is not a true reflection of arterial CO2.      Transcutaneous measurement of PCO2(PtcCO2) is a non-invasive method of measuring PCO2 that     has been used much less frequently due to technical difficulties with earlier transcutaneous     electrodes. Preliminary studies of the reliability of the current PtcCO2 electrodes (TOSCA,     Linde Medical Sensors, and Basel, Switzerland) have shown good correlation of arterial and     transcutaneous measurements in both adult volunteers and anesthetized subjects (5). PtcCO2 is     measured with a sensor attached by a low pressure clip to an earlobe. The sensor probe heats     the earlobe to 42 degrees Celsius to enhance blood flow. The current sensors have also been     evaluated in anesthetized children (7, 8), anesthetized adults (9, 10) and critically ill     neonates (11) and all these studies revealed a good correlation between PtCO2 and PaCO2.   "
236571|NCT00954746|"     The purpose of study AUX-CC-860 is to assess the durability of response of the AA4500     treatment regimen. This study will also evaluate long-term safety and progression of disease     in joints.   "
236572|NCT00954759|"     Infantile colic is a condition that affects more than 10% of babies and their families. The     reason, and hence the proper treatment, for this condition is unknown and many causes have     been suggested. One of the treatments that parents choose is chiropractic manipulation. In     Denmark, around 4,000 babies are treated for colic by chiropractors each year although the     effect of chiropractic treatment of infantile colic has not been properly scientifically     evaluated.      The effect of chiropractic treatment on infantile colic needs to be investigated since this     is a very common disorder with no known effective treatment but with good empirical evidence     of the value of chiropractic treatment. Although it is usually considered to be a benign and     self-limiting condition, some studies suggest there might be long-term effects in terms of     psychomotor problems. In worst case, the infants' crying may also lead to violence and     'shaken baby syndrome'.      Null hypothesis: There is no effect of chiropractic treatment on the course of infantile     colic.      This study is a controlled clinical trial, where infants fulfilling the diagnostic criteria     for colic will be randomized into two groups. One group will receive treatment and the other     won't. This will determine the overall effect and furthermore, subgroup analyses will be     performed to identify possible subgroups of infants who will benefit the most from the     treatment.      The results from subgroup analyses can help to identify children who might benefit from the     treatment. Then treatment can be initiated early and a lot of hardship can be avoided for     both the babies and the families.   "
236573|NCT00954772|"     The purpose of this research study is to investigate any changes seen in mood or behavior     following deep brain stimulation for movement disorders.   "
236574|NCT00954785|"     The aim of the study is to measure the effectiveness of treatment over 7 days with commonly     used anti-inflammatory medications namely etoricoxib and diclofenac (Voltaren) on reducing     the severity of pain, swelling and loss of function (range of movement, proprioception)     arising from a mild to moderate sprain (partial tear) of the lateral (outer) ligaments of the     ankle joint. This injury is commonly known as an ankle sprain.   "
236575|NCT00954798|"     The purpose of this study is to generate data on immunogenicity and safety of the monovalent     H1N1 vaccine in support of the development and registration.      Primary objectives:        -  To describe the immune response to study vaccine 21 days after each vaccination.        -  To describe the antibody persistence 8 months after the first vaccine administration          using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects          who received two injections.        -  To describe the immune response against the A/H1N1 strain using HAI method 21 days after          a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza          vaccine (TIV) administered 13 months after the first vaccination in a subset subjects          who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin          A/H1N1 strain.        -  To describe the safety profiles of study vaccines in all participants.   "
236576|NCT00954811|"     Our aim is to access whether we can achieve equivalent pregnancy rates by the addition of six     doses of luteal support with recLH after agonist triggering for IVF cycles in the absence of     OHSS.   "
236577|NCT00954824|"     People who are overweight are at increased risk of heart disease. Being overweight and having     heart disease are linked in that both involve inflammation. Inflammation refers to the body's     first line of defense against infection and injury. Metabolic changes in cholesterol,     triglycerides (fat in the blood) and sugar in the blood caused by inflammation are similar to     that in some people who are overweight. The investigators wish to examine the effects of     inflammation on these metabolic changes that may lead to heart disease.   "
236627|NCT00945126|"     The aim of the study is to investigate the feasibility and toxicity of allogeneic     haploidentical or unrelated transplantation with CD3/CD19 depleted stem cells associated with     a reduced or a standard conditioning regimen in pediatric patients with malignant and     non-malignant high-risk diseases, for whom allogeneic stem cell transplantation represents     the only possible therapy option and no human leukocyte antigen (HLA) compatible related     donors are available.   "
236578|NCT00954837|"     Thyroid nodules are common (prevalence of 12.7% in women), but are malignant in only 5% of     cases. International experts agree that a preliminary cytological examination by fine needle     aspiration (FNA) is required. The management of patients with cytological results consistent     with malignant or suspicious for malignancy nodules is well codified and generally involves     surgery. However, there is no consensus concerning 1) the utility of a second FNA during the     monitoring of benign nodules. Certain studies have recommended a second FNA, whereas others     have recommended ultrasound monitoring alone; 2) the contribution of ultrasound criteria to     the decision as to whether to carry out a second FNA, particularly if the nodule increases in     size; 3) the management of nodules classified as doubtful or suspect on needle biopsy, many     of which prove to be benign (20 to 30% are malignant), raising questions about the utility of     systematic thyroid surgery or the justification for a second FNA; 4) the management of     patients with non significant (NS) findings on FNA, for whom immediate surgery, monitoring or     a second FNA may be recommended and 5) the procedure to be followed for nodules present in     patients with multinodular thyroid disease.   "
236579|NCT00954850|"     The Canadian Severe Asthma Network (CSAN) was developed to gain a better understanding of the     clinical, environmental, socio-economic, work-related, and biological characteristics of     severe asthmatics (SA) that may account for poor response to clinically available therapies     for asthma.      This network of clinical and basic researchers will be a means by which Canadian     investigators can develop and conduct research in this small patient group, which could lead     to better clinical management of SA.      Patient information will be entered into the CSAN database (created by PI Dr. Vethanayagam in     connection with Mr. Jack Yeung) and will help researchers and doctors from multiple hospitals     and universities across Canada to understand this subpopulation of asthmatics better. It will     help to answer questions regarding SA epidemiology, asthma education, inflammatory     monitoring, risks of near fatal asthma (NFA), symptom perception, changes in lung structure     and function, co-morbidities, and the effectiveness of developing regional severe asthma     clinics. Two of the early projects the investigators will be working on are psychosocial     co-morbidities in asthma and medication coverage related to asthma.      There will also be biobanking of sputum samples and/or bronchoscopy samples (such as BALs &     lung washings) that are being obtained for clinical purposes. Also, for those consented for     biobanking blood and urine will be collected, separate from clinical care, and stored in the     biobank. The Canadian Biosample Repository (CBSR) will be storing our biobanked samples. The     investigators will be following the CBSR policies for storage and security. Tissue research     will be conducted in the future, and separate ethics approval will be obtained for each     project.   "
236691|NCT00945971|"     The study will investigate catecholamines responses, and cognitive effects of exercise in     children with attention deficit hyperactivity disorder, and the effect of exercise training     on these measures.   "
236580|NCT00954863|"     Based on the investigators previous study, seventy-four of 786 HIV-1 isolates (9.4%),     collected between 1999 to 2006, harbored one or more primary mutations associated with     antiretroviral resistance to reverse-transcriptase inhibitors (RTIs) or protease inhibitors     (PIs) in naïve patients. However, the drug resistance profiles for the HIV-1 integrase gene     is unclear. Three objectives are proposed:        1. To investigate and compare the drug resistance profiles for the HIV-1 integrase gene          between experienced and naive patients, who has not being exposed to Raltegravir.        2. To investigate and compare the drug resistance profiles for the HIV-1 integrase gene          between different subtypes (subtype B, CRF01_AE and CRF07_BC).        3. To identify potential amino acid mutations in the integrase gene, which might affect the          efficacy of Raltegravir.   "
236581|NCT00954876|"     The combination of capecitabine and cetuximab as first-line therapy will result in improved     progression free survival compared to single agent capecitabine in patients with KRAS wild     type colorectal cancer. Patients who are not able or willing to take Oxaliplatin/Irinotecan     combination therapy are eligible for this study.   "
236582|NCT00954889|"     The purpose of this study is to explore the efficacy and safety of tamsulosin 0.4mg (Harnal®     D. 0.2mg, 2T) in patients with LUTS/BPH refractory to tamsulosin 0.2mg (Harnal® D 0.2mg, 1T).   "
236583|NCT00954902|"     The purpose of this study is to assess whether feeding highly antioxidant spices of providing     these same antioxidants as capsules is able to affect cardiovascular risk measures. Because     this is a new area of research, the investigators will use many measures to assess this     question including blood markers, tests of blood vessel health, measures of blood pressure     responses, measures of clotting activity, and other inflammation measures.   "
236584|NCT00954915|"     The purpose of this study is to determine whether teplizumab is safe when administered     subcutaneously (by needle under the skin) in subjects with psoriasis. The study will also     evaluate how long teplizumab stays in the blood and how long it takes for it to leave the     body, what is the highest dose that can safely be given, and whether it improves psoriasis.   "
236585|NCT00944580|"     The purpose of this study is to determine the safety and immunological effects of a vaccine     for people diagnosed with high risk neuroblastoma, osteogenic sarcoma, and rhabdomyosarcoma.     It is hypothesized that this vaccine could reduce the incidence of relapse.   "
236605|NCT00944840|"     Malaria in African countries remains an important cause of mortality and morbidity among     young children. The global malaria control strategies include prompt treatment with an     effective antimalarial drug, vector control using ITNs or curtains, indoor residual spraying     (IRS), and intermittent preventive treatment. However, individually these interventions     provide only imperfect protection. Thus, there is a need to investigate whether additional     control measures provide added benefit in reducing mortality and morbidity. Therefore, 1312     children under 5 years of age living in villages and hamlets near Farafenni, The Gambia,     which form part of the rural Farafenni Demographic Surveillance system (FDSS) in North Bank     Region(NBR) were randomly allocated to receive IPTc or placebo from village health workers     based in primary health care villages. Treatment with a single dose of sulfadoxine     /pyrimethamine plus three doses of amodiaquine or placebo was given to all study subjects at     monthly intervals on three occasions during the months of September, October and November. In     addition, VHWs were trained to administer treatment with coartem to children if they develop     symptoms compatible with malaria during the malaria transmission season. The primary end     point was the incidence of clinical attacks of malaria detected during the study.   "
236586|NCT00944593|"     Diabetic 'Gastroparesis' or 'Gastroenteropathy' is a condition in which patients suffer     episodes of nausea, vomiting, abdominal bloating and pain after eating. These symptoms occur     in the absence of any structural abnormality of the stomach, rather abnormal gastric function     underlies the condition. Up to one in five patients with type I diabetes experience symptoms     consistent with this diagnosis. The effects on diabetic control, physical health and     emotional quality of life are severe. Patients do not respond reliably to general supportive     management or conventional medications. Surgical options have disappointing results. The need     for more effective treatment is acknowledged universally.      Feeding into the small bowel beyond the stomach (jejunal feeding) is established management     in diabetic patients with gastroenteropathy that are malnourished due to poor oral intake.     The benefits have been assumed secondary to improved nutrition and diabetic control; however     this assertion has never been studied. Recently we observed that patients with severe     gastroenteropathy recovered promptly and could eat normally during and for a few hours after     jejunal feeding. These observations suggest that jejunal feeding has 'quasi-pharmacological'     effects in patients with gastroenteropathy. One attractive explanation for these observations     is that gastroenteropathy represents a failure of oral intake to 'switch' the stomach from     the fasted to the fed state. According to this hypothesis, jejunal feeding 'restores' the     normal fed state by bypassing the dysfunctional stomach.      This project will assess the effects of feeding on gastrointestinal (GI) sensory and motor     function in diabetic gastroenteropathy. Healthy volunteers and diabetic controls without     symptoms will also be investigated. Studies will assess:        1. Effects on GI symptoms and function to gastric distension in fasted and fed states        2. Effects on GI symptoms and function to oral vs. nasogastric delivery of a test meal        3. A trial of gastric feeding with and without prior jejunal feeding on GI symptoms and          function Non-invasive magnetic resonance imaging (MRI) techniques will be applied to          assess complex gastric response to feeding. In addition the effects of feeding on          symptoms and gastric function will be related to alterations in GI hormones and          autonomic nervous activity (eg cardiovagal tone) to assess how the integrated response          of the GI tract to feeding fails in patients with diabetic gastroenteropathy.      The primary aim of this project is to assess the effectiveness of jejunal feeding in the     management of diabetic gastroenteropathy. However, by defining the processes that 'switch'     gastric function between the fasted and the fed states and control gastric emptying, we hope     also to identify candidate targets for more effective pharmacologic treatment of this severe     disease.        -  Trial with medical device   "
236587|NCT00944606|"     Other studies suggest that low Vitamin D levels may contribute to musculoskeletal pain.      Hypothesis: Administration of oral Vitamin D supplements will improve vague musculoskeletal     pain in children.   "
236588|NCT00944619|"     The main objective is to assess the efficacy and safety of overnight automated closed loop     glucose control using a computer-based algorithm compared with conventional insulin pump     therapy in adults with type 1 diabetes following the consumption of a moderate amount of     alcohol at dinnertime.   "
236589|NCT00944632|"     The purpose of this study is to determine the safety and efficacy of three concentrations of     ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic     dermatitis and to obtain dose-response information for the three concentrations.   "
236590|NCT00944645|"     This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg     Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.   "
236591|NCT00944658|"     Presently, there are very few treatments available which affect the progression of the     disease in the spine. The only proven treatment is the use of drugs inhibiting tumour     necrosis factor alpha (TNF). However, there are limitations with this treatment in that it     needs to be administered via an injection and is also very expensive. Therefore it is     necessary to develop new therapeutic agents for this condition.      Apremilast (the study drug) is an oral tablet which has been shown to inhibit TNF production     in a mouse model of inflammation. It has also been used in clinical trials for asthma and     psoriasis in humans with good affect and tolerability.      These studies were funded by Celgene Corporation and they will be funding this study.      This study will evaluate the effectiveness of apremilast in AS as measured by improvement in     patients' signs and symptoms of the disease and changes in imaging. Additionally the safety     and tolerability of apremilast in AS will be assessed. The patients will be recruited from     hospitals by Consultant referral. The patients will have had AS for at least 2 years and     their symptoms will have been uncontrolled on conventional non−steroidal anti−inflammatory     drugs such as ibuprofen. Patients will be randomised to either receive apremilast or a     placebo and treated over a period of 12 weeks. They will then be followed up for 28 days     after the treatment period.   "
236592|NCT00944671|"     A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew     tablet taken without water and with water compared to the Famotidine/Antacid tablet taken     with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.   "
236593|NCT00944684|"     Treatment of patients with chronic hepatitis C infected with genotype 1 hepatitis C virus     (HCV) consists of combined peginterferon/ribavirin for 48 weeks. Approximately 50% of     patients experience sustained virological response which equals cure. All other patients     either do not respond or experience recurrence of HCV virus and chronic hepatitis. Important     predictors of successful treatment are sustained dosing of both peginterferon and ribavirin.     With regard to the latter, clinical evidence indicates that higher ribavirin doses may in     fact even improve treatment outcome. However, high ribavirin doses cause hemolytic anemia     which require dose reductions. Recent clinical experience show that erythropoetic growth     factors, including erythropoetin, can counteract hemolytic anemia caused by antiviral     treatment in chronic hepatitis C patients. Therefore, the current trial aims to test whether     higher ribavirin doses adapted to a target plasma concentrations instead of a weight-based     dosing result in better healing rates, and whether ribavirin-associated hemolytic anemia can     be compensated by concommitant erythropoetin treatment.      Using a randomized, controlled, open-label design, the investigators hypothesize that     patients with high ribavirin doses adapted to plasma levels experience better viral clearance     than patients treated with standard weight-based ribavirin doses. In addition, the     investigators hypothesize that erythropoetin treatment will counteract hemolytic anemia     induced by ribavirin thereby allowing maintenance of target plasma concentrations without     ribavirin dose reductions.   "
236594|NCT00944697|"     To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of     pregabalin compared to pregabalin alone.   "
236595|NCT00944710|"     This study is designed to evaluate the effectiveness of adding a plano lens to weekend     atropine after visual acuity has stabilized with weekend atropine but amblyopia is still     present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic     eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed     by randomization of eligible patients to weekend atropine treatment with a plano lens over     the sound eye versus without a plano lens over the sound eye. The primary objective is to     determine if adding a plano lens to weekend atropine will improve visual acuity in patients     with amblyopia still present after visual acuity has stabilized with initial treatment.   "
236596|NCT00944723|"     The purpose of the study is to evaluate the use of plasma zinc concentration for assessing     the impact of mass zinc fortification programs.   "
236598|NCT00944749|"     Background:        -  Severe plastic anemia can lead to problems with bone marrow platelet production and          result in low blood platelet counts, which require frequent platelet transfusions to          improve blood clotting.        -  A standard treatment for SAA involves injections of rabbit-antithymocyte globulin          (r-ATG). r-ATG is developed by injecting horses with a type of human white blood cells          called thymocytes. The horse's immune system reacts against these cells and makes          antibodies that can destroy them. These antibodies are collected and purified to make          r-ATG. Horses can also be used for this procedure to make horse-antithymocyte globulin          (h-ATG).        -  h-ATG is approved by the Food and Drug Administration for the treatment of aplastic          anemia. h-ATG is a standard first-line method to treat aplastic anemia, but researchers          do not know how effective it is in patients who were first treated unsuccessfully with          r-ATG.      Objectives:      - To evaluate the effectiveness and safety of horse-ATG (with cyclosporine) in increasing     blood counts and reducing the need for transfusions in aplastic anemia patients who have     failed to respond to prior immunosuppressive treatment with rabbit-ATG and cyclosporine.      Eligibility:      - Patients 2 years of age and older who have consistently low blood platelet counts related     to aplastic anemia that has not responded to conventional treatment with rabbit-ATG.      Design:        -  After initial screening, medical history, and blood tests, patients will be admitted to          the inpatient unit at the National Institutes of Health Clinical Center. Researchers          will perform a skin test with h-ATG to check for allergic or other adverse reaction.        -  After the skin test, h-ATG will be given into a vein continuously over 4 days.        -  Cyclosporine will also be given to improve the response rate of ATG treatment. Treatment          with cyclosporine will start the same day as the h-ATG, either in liquid or capsule          form, and continued for 6 months. The dose of cyclosporine will be monitored and          adjusted based on blood levels and signs of side effects in the kidney and liver.        -  To prevent or treat infections that may result from cyclosporine s effect on the immune          system, patients will also take inhaled or capsule doses of pentamidine.        -  After the study is completed, patients will have followup evaluations every 3 months, 6          months, and annually for 5 years. Evaluations will include blood samples and periodic          bone marrow biopsies.   "
236599|NCT00944762|"     This study will determine the effectiveness of a specialized psychotherapy for treating     elderly stroke survivors who are depressed.   "
236600|NCT00944775|"     Background: The impact of the known non-invasive cardiac indices for identification of     hemodialysis (HD) patients at high-risk for sudden cardiac death (SCD) has not been     evaluated.      Patients: Fifty-nine HD patients were randomized into 2 groups. Thirty of them (group A-aged     54.6±8.9 years) participated in a supervised training program with stationary bicycles during     their HD sessions (3/weekly) for 10 months, while the rest (group B-aged 53.2±6.1 years)     remained untrained and were used as controls.      Study hypothesis: Exercise training will affect most of the non-invasive cardiac markers of     SCD and the total score positively.      Method: At entry, as well as at the end of the study all subjects underwent a cardiopulmonary     exercise testing (estimation of aerobic capacity-VO2peak), an echocardiographic study (LV     ejection fraction -LVEF evaluation), an ambulatory 24-hour Holter monitoring for cardiac     autonomic nervous system activity evaluation by time- and frequency- domain heart rate     variability (HRV) calculation (measurement of SDNN, mean RR and low to high frequency     ratio-LF/HF), a signal-averaged ECG (late potentials-LP documentation) and a submaximal     exercise test for microvolt-T-wave alternans (TWA) detection.   "
236601|NCT00944788|"     The purpose of this study is to test the effects on a number of health outcomes and the     feasibility of a structured program of qi-gong, a form of tai-chi which has been previously     tested in older populations, in older hospitalized patients. In particular, this pilot study     aims to assess changes in quality of life and depressive symptoms after 4 weeks of treatment,     with the hypothesis that this intervention will have a positive impact on these two domains,     compared to usual care. Adherence will be also monitored in the intervention arm.   "
236621|NCT00945048|"     The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac     diseases. The current standard methods for the determination of the CO, however, are either     invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic     resonance tomography, MRT). Therefore the aim of the study at hand was to evaluate the     electrical velocimetry technique as a new method for determining the CO and to compare this     new technique with the Inert Gas Rebreathing Method and with the Magnetic Resonance     Tomography   "
237280|NCT00963742|"     The objectives of this multi-center clinical investigation are to determine the safety and     effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one     year of post-operative assessment.   "
236602|NCT00944801|"     Glioblastomas represent 40% of all tumors of the central nervous system (CNS) and are among     the most lethal tumors. Temozolomide (TMZ) combined with radiotherapy was the first substance     to significantly improve the overall survival (to 14.6 months) as compared to surgery and     radiotherapy alone and increased the proportion of patients surviving more than 2 years to     26%. TMZ showed the best efficacy in patients with a methylated O6-methylguanine-DNA     methyltransferase (MGMT) promoter in part by eliminating stem cell-like tumor cells. Among     patients with a methylated MGMT promoter, the median survival after treatment with combined     radio-chemotherapy was 21.7 months, as compared to 15.3 months among those who were assigned     to radiotherapy only. In the absence of methylation of the MGMT promoter, there was a smaller     and statistically insignificant difference in survival between the treatment groups.      Doxorubicin is one of the most effective substances in vitro against cells derived from     glioblastoma. However, it has no significant effect in vivo due to poor blood-brain-barrier     penetration. In a tumor model, tissue and CSF-concentrations of doxorubicin were     substantially increased when sterically stabilized liposomes were used resulting in a     comparable clinical response using approximately half of the dose of stabilized liposomes     compared to conventional doxorubicin. A pegylated formulation (PEG-liposomal Doxorubicin)     even further improved the penetration of the blood-brain barrier. Case series and two phase     II-studies in patients with recurrent glioblastoma have shown modestly promising results for     PEG-Dox.      In this study, the investigators treated patients with recurrent glioblastoma with 20 mg/m2     PEG-Dox on days 1 and 15 of each 28-day cycle. To determine the dose limiting toxicity of     PEG-Dox combined with prolonged administration of TMZ, the investigators performed a phase I     part ahead of the phase II study. To investigate, by means of a historical control analysis,     if the addition of PEG-Dox to TMZ and radiotherapy improves the survival of patients, the     investigators chose similar inclusion criteria and identical TMZ and radiotherapeutic regimes     as in the EORTC26981/NCIC-CE.3 study.   "
236603|NCT00944814|"     The purpose of the study is to assess the acceptability of the two lipid-based nutrient     supplement (LNS) formulations containing no zinc and a high amount of zinc (10 mg zinc / 20 g     dose of LNS). The hypothesis is that both products will be equally accepted by children and     mothers.   "
236604|NCT00944827|"     There is a positive correlation between serum's cholesterol levels and death from     cardiovascular disease, especially coronary artery disease. The reduction of plasma lipids     levels is one of the main goals of prevention. Research has shown that green tea has     beneficial effects on health due to the polyphenolic substances (catechins) that it contains.     Studies have shown that prolonged consumption of polyphenols has a positive effect on factors     related to cardiovascular risk such as obesity, dislipidemia and various indicators of     oxidative stress.      The aim of this study was to examine the possible effects of catechin supplementation, in     combination with the classic treatment for the reduction of hypercholesterolemia, statin     therapy, on the treatment's effectiveness and in the reduction of classic side effects.   "
236606|NCT00944853|"     The study aims to compare the effects of two different formulations of zinc supplements on     plasma zinc concentrations among young Burkinabe children.   "
236607|NCT00944866|"     The selective cyclooxygenase-2 (COX-2) inhibitors have been associated with increased     cardiovascular risk. The goal of the present study is to investigate the impacts of COX-2     inhibitors on biochemical indices in cardiovascular disease. As the reviewer suggested, the     investigators propose to study the effects of Cox-II inhibitor using experimentally induced     hyperlipidemic rats. Plasma total cholesterol, LDL and triglyceride concentrations will be     determined before and after animals treated with cyclooxygenase-2 (COX-2) inhibitors.     Biochemical markers related to cardiovascular events including prostaglandin I2,     thromboxaneA2 and others will also be investigated. The investigators will also investigate     these biochemical markers in patients taking Celecoxib and NSAIDs. The investigators hope     these studies will reveal clinically useful biochemical markers for cardiovascular events in     patients taking Cox-II inhibitor.   "
236608|NCT00944879|"     This study will use the licensed HPV vaccine, Gardasil, as a surrogate for an HIV vaccine, in     order to explore some of the ethico-legal,psycho-social and logistical challenges involved in     running an HIV vaccine trial in adolescents.   "
236609|NCT00944892|"     This is a double-blind, prospective, randomized study in which patients will be randomized to     1 of 4 treatment arms (3 active and 1 placebo).      Each patient will receive two doses of active medication or placebo, with study drug     administered intravenously (IV). The primary goal of the study is to assess the safety and     tolerability of repeat administrations of REGN475 compared to placebo in patients with     osteoarthritis (OA) of the knee.   "
236610|NCT00944905|"     The purpose of this study is to determine if MDX-1203 is safe for the treatment of renal cell     carcinoma or non-hodgkin's lymphoma.   "
236611|NCT00944918|"     A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant     Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally     advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to     Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex     treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.   "
236622|NCT00945061|"     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill     tumor cells. It is not yet known whether a single dose of radiation therapy is more effective     than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.      PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works     compared with radiation therapy during surgery in treating patients with recurrent breast     cancer.   "
236692|NCT00945984|"     Surgical resection is the only potential curative treatment available for renal cell     carcinoma. The purpose of this study is to clarify the surgical and oncologic outcomes of     laparoendoscopic single-site radical nephrectomy for localized Renal Cell Carcinoma.   "
236612|NCT00944931|"     Background:        -  Direct current (DC) brain polarization is a technique in which very weak electricity is          applied to the head. Doctors have used DC polarization for many years on patients and          healthy people with no known serious side effects. Earlier, researchers found that DC          polarization can temporarily improve the ability of healthy people to think of certain          words.        -  A disadvantage of existing methods of DC polarization is that they use large electrodes          and the current spreads over a large area of the brain. This makes it difficult to          target particular brain areas. High-density DC polarization uses several small          electrodes to focus the current in a small area of the brain. This study will test          high-density DC polarization for the first time in humans.      Objectives:        -  To see how well high-density direct current polarization works in the brain.        -  To test a new method of performing direct current brain polarization.      Eligibility:      - Healthy, right-handed adults, ages 18 and older, who have no history of neurological or     psychiatric illnesses.      Design:        -  After an initial screening visit with clinical examination, participants may be assigned          to one or both experiments of the study.        -  Experiment 1: Participants will have electrodes placed on the left side of their heads,          and will be asked to say aloud as many words as they can think of that begin with          certain letters. After the high-density DC polarization current is turned on and run for          10 minutes, participants will say words beginning with a different set of letters and          perform reaction time and thinking speed tests. Some participants will receive real          polarization and others will not, although all participants will be told that they are          receiving the polarization.        -  Experiment 2: Participants will have DC brain polarization performed with transcranial          magnetic stimulation (TMS), which uses magnetic pulses to activate nerve cells in the          brain. We will use TMS to help us understand how far the effect of DC polarization          spreads in the brain. After attaching electrodes to a point on the scalp above the ear,          researchers will give about 50 TMS pulses to five different places near this area. These          pulses will produce some painless muscle twitches in the hand or arm. The TMS pulses          will be followed by the DC brain polarization, and then by another set of TMS pulses to          see if there are any differences in muscle response.   "
236613|NCT00944944|"     The purpose of this study is to evaluate if the Gynecologic Cancer Lymphedema Questionnaire     (GCLQ) truly detects symptoms or signs of lower extremity lymphedema in patients with     diagnosed lower extremity lymphedema. Lymphedema is a chronic condition in which fluid     accumulates in the tissues of the body. Many cancer survivors are living with discomfort and     changes in their activities due to limb swelling following cancer treatment. If the GCLQ is     able to do detect signs and symptoms of lymphedema, the investigators hope to use it as a     tool in the clinical care setting to help identify women at risk for or with lymphedema. In     the future, this could improve clinical care through the use of a more simple and feasible     way to identify lower extremity lymphedema than measuring limbs.   "
236614|NCT00944957|"     Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams,     dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of     treatment, with subsequent attenuation but may not completely resolve even years after     efavirenz initiation.      The investigators plan a four week, randomized, placebo-controlled, double-blind study. In     group 1, efavirenz will be replaced with efavirenz placebo plus raltegravir, in group 2,     efavirenz would be continued, and raltegravir placebo given in addition. After two weeks,     patients in group 1 would switch to the regimen of group 2, and vice versa.      The primary endpoint of the trial will be patient preference. Sleep quality, daytime     sleepiness, and anxiety will also be investigated.   "
236615|NCT00944970|"     Binodenoson (an experimental drug) and adenosine (an FDA-approved drug that is currently used     by doctors) are used to increase blood flow to the heart just like when a person exercises on     a treadmill. Using imaging techniques, this increased blood flow can help determine if areas     of the heart are not getting enough blood and oxygen during exercise. The purpose of the     study is to determine if binodenoson is as good as adenosine in determining if there are     areas of the heart not getting enough oxygen when blood flow to the heart is increased.   "
236616|NCT00944983|"     Clinical validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitoring     system according to the accuracy guidelines of the ISO 80601-2-30 Standard in Adults,     Adolescents, and Children.   "
236657|NCT00945516|"     The purpose of this study is to determine the feasibility, easy removability, safety, and     migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring     FCSEMS for benign biliary stricture.   "
236617|NCT00944996|"     The neuropeptide Pituitary Adenylate Cyclase Activating Polypeptide (PACAP) and its receptors     PAC1 and VPAC2 are widely expressed in the nervous system. The investigators found that PACAP     treatment of neuronal cell cultures increases expression of Brain Derived Neurotrophic Factor     (BDNF) that plays an important role in the etiology of psychiatric disorders and action of     antidepressants. For the first time, the investigators demonstrated that treatment by     Paroxetine and Citalopram significantly decreases PAC1 and VPAC2 and upregulates PACAP mRNA     expression, whereas Imipramine shows an opposite effect. Moreover, PACAP, PAC1 and VPAC2     expression is highly correlated with BDNF expression. Their in vivo studies show that     Imipramine reduces BDNF and increases PAC1 mRNA expression in murine hippocampus, suggesting     that antidepressants may affect neuronal plasticity through PACAP-BDNF interactions. Based on     their observations in experimental systems, the investigators hypothesize that PACAP     signaling system may be involved in the etiology of depression and mechanism of     antidepressant action. The investigators will evaluate this hypothesis by examining serum     PACAP levels, effect of antidepressants on PACAP levels, and gene polymorphisms of PACAP and     its receptors in major depressive disorder patients. This study will enhance the     investigators' understanding of PACAP's role in the etiology of depression and antidepressant     treatment and will provide a basis to evaluate PACAP pathway as a potential target for     diagnostics and novel antidepressants drug discovery.   "
236618|NCT00945009|"     This phase III clinical trial is studying how well combination chemotherapy and surgery work     in treating young patients with Bilateral Wilms tumor and children who are a special risk for     forming tumors in both kidneys. Drugs used in chemotherapy work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination     chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed. Giving it after surgery may kill any tumor cells that remain after     surgery.   "
236619|NCT00945022|"     Following waking up from surgery performed under general anesthesia, patients are suffering     from discomforting oral dryness, and moreover, they are not allowed drinking for 24 hours.     The current management involves the wetting of patient's lips using wet bandage. This action     is dependent on the presence of a family member or a nurse, which is not always possible.     Many patients describe the oral dryness as a suffering, added to the suffering anyway     entailed by surgery.      The investigated Lipsus device is intended for oral wetting, relieving patient's suffering     and minimizing the dependence on continuous presence next to patient's bed.   "
236620|NCT00945035|"     This study will establish the bioequivalence of the 20%, milled, roller compaction final     market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib     tablets.   "
236693|NCT00945997|"     To compare the efficacy of two different dose regimens of misoprostol administered vaginally     in combination with mifepristone in second trimester termination of (non)viable pregnancy.   "
236623|NCT00945074|"     The objective of this study is to test the efficacy of a symptom management treatment     strategy, namely, Acupuncture/Moxibustion (Acu/Moxa) to improve the symptoms associated with     Irritable Bowel Syndrome (IBS) in persons between the ages of 18 to 70 years.      IBS has been defined as abdominal pain or discomfort in the mid or lower gastrointestinal     (GI) tract, associated with defecation or a change in bowel patterns and with features of     disordered defecation. Current therapies include dietary modification, psychotherapy and     pharmacological therapies. Traditional eastern approaches offer a therapeutic approach to     symptom management that is subtle, holistic and holds promise as an intervention for IBS.      This study will enroll 171 men and women experiencing IBS with diarrhea (IBS-D) defined by     the ROME III criteria. Subjects will be randomized (by chance) to one of three experimental     intervention conditions: Condition 1,subjects receive Standard Acu/Moxa; Condition 2,     subjects receive Individualized Acu/Moxa and Condition 3, subjects receive Sham     Acupuncture/Placebo Moxibustion(control group).      Subjects will attend a screening/intake session followed by two treatment sessions per week     for 4 weeks, one treatment session per week for 4 weeks, and 2 non-treatment follow-up     sessions at weeks 12 and 24. All subjects will be assessed by a diagnostic acupuncturist     (blinded to treatment assignments), receive interventions appropriate to their condition     assignment by treating acupuncturists, be administered the same instruments, and submit their     symptom diaries for data entry and analysis. All subjects will complete a prospective symptom     diary for the duration of the study.   "
236624|NCT00945087|"     The primary purpose of this experimental therapy is to treat, with the aid of bacteriophages,     patients with non-healing postoperative wounds or bone, upper respiratory tract, genital or     urinary tract infections in whom extensive antibiotic therapy failed or the use of the     targeted drug is contraindicated.   "
236625|NCT00945100|"     This study is designed to evaluate the effectiveness of increasing prescribed patching     treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment     and amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to     20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching     until no improvement, followed by randomization of eligible patients to patching 2 hours     daily versus an average of 6 hours daily (42 hours per week). The primary objective is to     determine if increasing patching dosage will improve visual acuity in patients with amblyopia     still present after visual acuity has stabilized with initial treatment.   "
236626|NCT00945113|"     The aim of the study is to answer the question: Is a large-scale research study of the     effectiveness of group speech and language therapy (SALT) for young people who stammer     possible?      The study will look at the issues involved in setting up a large-scale investigation of     treatment for young people who stammer. It will inform the investigators whether larger     studies would be possible and give some early-stage information on the effectiveness of group     SALT for these young people. The findings will pave the way for building and testing out     treatment programmes where there will be clear positive benefit for young people who stammer     and their families.      To answer the research question, the study will tell the investigators (a) how easy/difficult     it was to get people to take part, (b) young people and parents'/carers' views on taking part     and (c) whether the assessments were able to pick up changes in speech and attitudes towards     stammering reported by the young people and their carers.      Sufficient numbers of participants were not recruited to carry out the intended rehearsal     pilot RCT study design.   "
236630|NCT00945165|"     Hyperglycemia is an independent risk factor for the development of diabetic complications in     type 2 diabetes. Exercise improves glycemic control, however, the role of exercise     characteristics (e.g. intensity, type of exercise, timing, frequency) remains to be     elucidated.      This study aims to assess the effect of several exercise characteristics on hyperglycemia in     various subgroups of type 2 diabetes patiënts.   "
236631|NCT00945178|"     The study will investigate how a new formulation of the study drug is absorbed, metabolised     and distributed through the body, as well as its safety and tolerability in higher doses when     given as single and multiple doses and as a single dose in the presence and absence of     naproxen.   "
236632|NCT00945191|"     This is a trial to see what effects a combination therapy with CS-1008 and     Paclitaxel/Carboplatin will have on a patient's response in locally advanced or metastatic     ovarian cancer.   "
236633|NCT00945204|"     The aim of this trial is to assess the effectiveness of intermediate care clinics for     diabetes, compared to usual care.   "
236684|NCT00945880|"     The purpose of this study is to test the hypothesis that clemizole hydrochloride is safe and     well tolerated when administered to subjects who are infected with hepatitis C virus and have     not yet received treatment. This study will also examine how the virus and body respond to     clemizole hydrochloride.   "
236685|NCT00945893|"     The purpose of this study was to determine the safety and descriptive immunogenicity of the     H1N1 influenza vaccine in healthy adults.   "
236694|NCT00946010|"     The purpose of this study is to investigate the differences of genotypes of hepatitis B and     hepatitis C in Taiwan.   "
236634|NCT00945217|"     Atherogenic dyslipidemia is characterized by high levels of apolipoprotein B     (apoB)-containing lipoproteins, including very-low-density lipoprotein (VLDL) and its     remnants and small, dense LDL (sdLDL) particles, and reduced levels of high-density     lipoprotein cholesterol (HDL-C). The National Cholesterol Education Program (NCEP)     recommended using non-high-density lipoprotein cholesterol (non-HDL-C) to surrogate     atherogenic lipoproteins in clinical practice. Recently, the investigators have done a pilot     study to study the associations between SAH gene variants and atherogenic dyslipidemia     (surrogated by non-HDL-C) in postmenopausal women. The investigators found that homozygosity     for SAH haplotype 3 was associated with increased adiposity, insulin resistance, and elevated     levels of non-HDL-C in the postmenopausal women. Based on the findings of the pilot study,     the investigators plan to expand the cohort of postmenopausal women to about 800 women, that     is, recruited 660 new subjects in two years. The associations between non-HDL-C and the SAH     gene family will be done. Fasting blood sampling for buffy coats and lipids is the core test     of Study 2. A 75-g oral glucose tolerance test (OGTT) will be available as an optional test     for a better phenotyping of insulin resistance for the participants. Detailed lipid profiling     including measurements of VLDL cholesterol, VLDL-TG, remnant lipoprotein, LDL particle size,     apoA1, apoB, and apoCIII will be done in the second year of the study if significant     associations between gene variants of the SAH gene family and non-HDL-C are detected.   "
236635|NCT00945230|"     The study examines and illustrates the utility of utilizing actigraphic measurements to     assess treatment response.   "
236636|NCT00945243|"     This is a multi-center, prospective, outcomes study. In this study, the Zero-P PEEK implant     will be used in patients undergoing ACDF for treatment of SCDD at a single level between C3     and C7. The cohort will be followed over time to twenty-four (24) months after surgery. Up to     fifteen (15) sites will participate in this study. This is not a controlled study.   "
236637|NCT00945256|"     The purpose of this study was to examine the role skeletal muscle perfusion plays in     mediating muscle protein synthesis in healthy older and younger individuals. The     investigators hypothesized that normalization of muscle perfusion in older men and women via     exercise or infusion of a vasodilator would enhance nutritive flow and skeletal muscle     protein synthesis in the elderly similar to that of their younger counterparts.   "
236638|NCT00945269|"     RATIONALE: White blood cells that have been treated in a laboratory may be able to kill tumor     cells in patients with melanoma. Aldesleukin and denileukin diftitox may stimulate the white     blood cells to kill melanoma cells. Giving therapeutic autologous lymphocyte therapy together     with aldesleukin and denileukin diftitox may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects of giving therapeutic autologous     lymphocytes together with aldesleukin and denileukin diftitox and to see how well it works in     treating patients with stage III-IV melanoma   "
236639|NCT00945282|"     GSK has in-licensed a novel NNRTI-class candidate (GSK2248761, IDX12899) for the treatment of     subjects with HIV-1 infection from Idenix Pharmaceuticals. Idenix Pharmaceuticals completed a     proof-of-concept study evaluating GSK2248761 monotherapy over seven days in forty     treatment-naïve subjects infected with HIV-1. GSK2248761 doses sequentially evaluated were     800 mg QD, 400 mg QD, 200 mg QD and 100mg QD.      This study will evaluate a lower dose, or doses, of GSK2248761 to better characterize the     dose-response and concentration-response curves. The results from this study will be used to     select doses for future clinical studies in HIV-1 infected subjects.   "
236640|NCT00945295|"     The purpose of this study is to determine if a combination of botulinum neurotoxin A and     rehabilitation therapy is better than botulinum neurotoxin A alone for improvement in     function based on the Fugl-Meyer and other validated measures.      Hypothesis: The combination of botulinum neurotoxin A and rehabilitation therapy will produce     better functional improvement than botulinum neurotoxin A alone in post-stroke upper limb     spasticity measured by the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke.   "
236641|NCT00945308|"     The achievement of high local concentration of Eptifibatide, a GP 2b3a inhibitor,via direct     intracoronary injection, promotes (in vitro) clot disaggregation. It remains unclear if it is     of superior benefit than the routine intravenous administration of these agents.      In patients presenting with acute myocardial infarction, and undergoing primary coronary     intervention, intracoronary administration of Eptifibatide may increase local drug     concentration by several orders of magnitude and promote clot disaggregation with a minimal     increase in systemic drug concentration, and in that way enhancing myocardial perfusion and     survival.   "
236642|NCT00945321|"     This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a     single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food     on the bioavailability of oral aprepitant.   "
236643|NCT00945334|"     In this study the investigators aim to compare the efficacy of neomycin to a combination of     rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test.     This study will be conducted in collaboration with Dr. John DiBaise at the Mayo Clinic in     Scottsdale, AZ and Dr. Satish Rao in Georgia Regents University in Augusta, GA.   "
236644|NCT00945347|"     The purpose of this study is to investigate within a short delay the effect of nasal     instillation of Miglustat on nasal potential difference in cystic fibrosis patients     homozygous for the F508del mutation.   "
236645|NCT00945360|"     Fibroids are benign tumors that might results in bleeding. Surgery is their definitive     treatment. Some medical therapies have been tried for women who wish to preserve their     uterus. Recent reports have demonstrated a role for a new category of drugs called aromatase     inhibitor (such as Femara) in the treatment of fibroids. This study is conducted to assess     the effect of Femara (letrozole) on the size of fibroids in women around menopause.   "
236646|NCT00945373|"     The purpose of this study is to determine the efficacy of calcium dobesilate in combination     with pulsed dye laser for the treatment of rosacea.   "
236647|NCT00945386|"     Pediatric patients, during their illness often treated with furosemide (Lasix) continuous     drip, often, with dosages above 4-6mg/kg/day (the recommended dose).      This study will monitor hearing status of these children prior to their therapy with     furosemide, during this therapy and after.   "
236777|NCT00947102|"     Observational study of influence of gemcitabine treatment on serological and immunological     status and gene expression profile in patients with pancreatic tubular carcinoma after tumor     resection.   "
236648|NCT00945399|"     CARTIPATCH® is an Autologous Chondrocyte Implantation product including functional cells in a     matrix, indicated for the treatment of isolated osteocartilaginous lesions. The submitted     protocol is a Phase III multicentric, prospective, controlled and randomized clinical trial,     sponsored by TBF Génie Tissulaire, France. The main objective of the protocol is to compare     the clinical improvement of the IKDC subjective score between the microfracture-treated group     and the CARTIPATCH® chondrocyte graft-treated group , 18 months following surgery. Several     secondary objectives were determined. The microfracture procedure will be conducted in one     operative step, during arthroscopy and CARTIPATCH® procedure will be conducted in two     operative steps:        1. Arthroscopy to collect cartilage;        2. Implantation following arthrotomy about 6 weeks following arthroscopy.      Both groups will follow the same rehabilitation program.   "
236649|NCT00945412|"     The ultimate goal of this work is to establish a method for control bleeding after     tonsillectomy in awake children. Treatment of post-tonsillectomy bleeding in children     typically requires general anesthesia with currently used electrocautery techniques.     Micropolysaccharide hemosphere technology is a unique absorbable agent that helps clot form.     These hemospheres consist of 100% purified plant starch that enhances natural clotting by     concentrating blood solids such as platelets, red blood cells, and blood proteins on the     particle surfaces to form a gelled matrix. This device provides painless, non-irritating     control of bleeding, and has been used effectively for control of nosebleeds in awake adult     patients. This device, however, has not been tested in the tonsillar fossae in children;     thus, this study is performed to determine if at least 50% of children with bleeding     tonsillar fossae can be spared rescue treatment with electrocautery.   "
236650|NCT00945425|"     The purpose of this study is to evaluate the safety and tolerability after repeated ascending     doses of AZD7325 in Japanese healthy male subjects.   "
236651|NCT00945438|"     This study is in support of the annual application for the variation of the vaccine strains     for a marketing authorisation.      Objectives:        -  To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the          intradermal (ID) influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation.        -  To describe the safety of the corresponding strength of the ID influenza vaccine, NH          2009-2010 formulation.   "
236652|NCT00945451|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less     damage to normal tissue. Giving stereotactic radiosurgery after docetaxel and cisplatin may     kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and the best dose of stereotactic     radiosurgery when given after docetaxel, cisplatin, and radiation therapy and to see how well     it works in treating patients with stage III non-small cell lung cancer.   "
236653|NCT00945464|"     Breast cancer is a disease of complex origin with a strong genetic component. The incidence     of breast cancer is very high in monozygotic twins of patients, and it is thought that a high     proportion and perhaps the majority of breast cancers arise in a small number of genetically     susceptible women. Recent studies in human genetics have discovered several intervals in the     human genome containing inherited variants that are statistically associated with the     propensity to develop breast cancer. The investigators plan to use this knowledge to design a     genetic screening test to guide recommendations for breast cancer screening with mammography.     If the small group of genetically susceptible women can be identified, more effective breast     cancer screening strategies can be implemented. In contrast, a very large proportion of women     who undergo yearly mammography are at exceptionally low risk from a genetic perspective.     Using genomic guidance could eventually reconfigure the most efficacious strategy to screen     women for early detection of breast cancer.      By developing a genetic screening panel based on genetic markers for breast cancer, the     investigators will be able to more accurately determine a woman's individual risk for     developing breast cancer.   "
236654|NCT00945477|"     A growing body of literature supports the role of angiogenesis in the development and spread     of a variety of human cancers including prostate cancer.        -  Vascular endothelial growth factor (VEGF) expression is low in normal prostate tissue,          but markedly increased in tumor tissues, and has a positive association with tumor stage          and grade        -  Plasma VEGF levels are significantly elevated in patients with hormone refractory          prostate cancer (HRPC) compared to those patients with localized disease and have been          associated with disease progression in other cancer patient population.        -  The Cancer and Leukemic Group-B demonstrated that VEGF levels correlate with survival.      Pazopanib is a potent multi-target receptor tyrosine kinase inhibitor of vascular endothelial     growth factor receptors.   "
236658|NCT00945529|"     Pleural effusions continue to be a post-operative complication seen after Fontan operation.     This study will examine the use inhaled nitric oxide given for 54 hours after Fontan     operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after     Fontan operation will improve fluid balance, thus decreasing the incidence of pleural     effusions and shortening hospital stay.   "
236686|NCT00945906|"     Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with     potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose     blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual     clotting process, thereby preventing bleeding.      In this study, patients will be treated with FXIII Concentrate (Human) and followed closely     to determine that they receive the dose of FXIII Concentrate (Human) that will best minimize     the chance of bruising and bleeding. The purpose of the study is to provide FXIII Concentrate     (Human) to patients until the product becomes commercially available in the United States.   "
236659|NCT00945542|"     Background: Bleeding and coagulopathy still accounts for the majority of early in-hospital     deaths following trauma. There have been lately several published studies suggesting that     higher transfusion ratios of fresh frozen plasma (FFP), platelets (PTL) and cryoprecipitate     (CRYO) to red blood cell (RBC) are associated with survival advantages. However, the evidence     comes from retrospective data limited by a significant number of unaddressed confounders. In     addition, the use of blood products bears known and important risks of complications.      Hypothesis: The adoption of a formula-driven transfusion practice with pre-defined ratios of     FFP to PTL to RBC transfusion (1:1:1) is feasible and superior to current laboratory-guided     transfusion practice in treating and/or preventing early coagulopathy improving survival     rates in massively bleeding trauma patients .      Objective: To exam the feasibility of implementing a pre-defined ratio of FFP to PTL to RBC     (1:1:1) transfusion protocol and its impact on a population of bleeding trauma patients.      Design: A two-year pilot feasibility randomized control trial at Sunnybrook Health Sciences     Centre. Randomization: 70 patients are expected to be randomized to lab-driven or to     formula-driven massive transfusion protocol and followed-up to 28 days or hospital discharge.      Study outcomes: protocol violation; in-hospital mortality by exsanguination; death at 28     days; coagulation competence defined by current standard coagulation tests (INR & PTT < 1.5     times normal; PTL ≥ 50 and Fibrinogen ≥ 1.0) or clotting factor levels ≥ 30%; correlation of     current standard coagulation tests with clotting factors levels; cessation of bleeding;     incidence of ALI, sepsis, MOF, transfusion-related circulatory overload, transfusion     reactions; Ventilator-free days; ICU & Hospital LOS; thromboembolic events.      Intervention protocol: Transfusion of pre-defined ratios of FFP and PTL to RBC (1:1:1)     (formula-driven) for the first 12h of hospitalization without coagulation tests guidance     while patient is hemorrhaging or before if bleeding stops.      Statistical analysis: protocol compliance rate and in-hospital mortality rates within 24h and     at 28 days will be assessed using Chi-square test. ROC analysis will be used to analyze     coagulation competence.      Main expected outcomes: implementation of a formula-driven transfusion protocol is feasible     and coagulation competence will be achieved faster and more efficiently in the study group.   "
236660|NCT00945555|"     The purpose of this study was to define and classify antibacterial agents used in Turkey for     patients with febrile neutropenia.   "
236661|NCT00945568|"     The aims of this study are (1) to study the benefit of branched-chain amino acids enriched     nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the     duration of hospitalization after the surgery, and (2) To investigate the postoperative     quality of life (QOL) in receiving peri-operatively branched-chain amino acids enriched     nutrient-mixture in patients who undergone the hepatic management for hepatocellular     carcinoma (HCC) with chronic liver disease.   "
236662|NCT00945581|"     The primary objectives are to evaluate the effect of AN777 on muscle strength loss that     occurs during bed rest, and to investigate whether AN777, in association with resistance     training, will support muscle strength recovery following bed rest in healthy elderly     subjects.   "
236663|NCT00945594|"     The primary purpose of this study to assess patient pain scores comparing rigid to flexible     cystoscopy in females; to assess post procedural complications, including frequency, urgency,     infection and time to resolution of these symptoms between the two procedures; to assess     physician perception of patient pain or discomfort with flexible or rigid cystoscopy.   "
236664|NCT00945607|"     The primary objectives of this study are to determine if the use of Guided Relaxation     Training (GRT) during cancer treatment in individuals with newly diagnosed breast cancer     increases their ability to cope as measured by the Coping Self-Efficacy Scale (CSES) and     reduces their perceived stress as measured by the Perceived Stress Scale (PSS).   "
236665|NCT00945620|"     The primary aim of this study is to measure the magnitude and duration of trans-abdominis     plane (TAP) block analgesia in parturients undergoing elective cesarean section with     concurrent standard of care operative analgesic regimens including intrathecal morphine     sulfate (ITMS). A one sided block model takes advantage of the bilateral nature of the pain     created by a bilateral surgical wound and allows each patient to serve as her own control.     Reduced variability allows a more definitive establishment of analgesic benefit for this     block.      The current reports of conflicting data regarding efficacy make uncertain the role of TAP     block in post cesarean section pain relief. This model would have a better potential for     measuring the block's effectiveness. Quantitative sensory evaluation tools such as the von     Frey hair tool provides a quantitative reproducible measure of skin sensation and also allows     for assessment of block regression over time. Pressure algometry has been established as a     clinical and research tool for quantitative assessment of pain levels in multiple pain     conditions. A useful inexpensive reliable pressure algometer has recently been described.      The assessment of serum ropivicaine levels with this block will provide useful data regarding     the systemic absorption of local anesthetic compared to other peripheral nerve blocks and     establish the safety of the technique.      In addition this study will help establish a model for the study of TAP block modifications     in the future. If block effectiveness is demonstrated, this model can be used to examine     numerous block parameters including choice of local anesthetic and dose response analysis for     optimal volume and concentration. Potential future study may be done also in the area of     adjuncts found to have increased duration and effectiveness as used in other peripheral nerve     blocks.      Expected duration of this study is 18 months.   "
236666|NCT00945633|"     Dietary intervention and other strategies to prevent unhealthy weight gain and the     development of obesity should be based on knowledge of dietary, physiological, genetic and     behavioral determinants and their contributing interactions. Identifying these determinants     is difficult because physiological susceptibility to specific dietary and behavioral factors     implicated in unhealthy weight gain differs between populations and individuals within the     populations. The research challenge is identifying specific determinants in a free-living,     adult population.      Understanding the interaction between diet and the underlying susceptibility factors such as     physiologic, genetic and epigenetic, and behavioral factors mandate an integrated approach.      This integrated approach should include understanding the interplay of physiological factors     (genetics, epigenetics, taste preferences, susceptibility to energy excess, etc.) and     behavioral factors (food cravings, restraint, disinhibition, physical activity) as each of     these domains is a potential driving force in energy expenditure, food preference, dietary     choices, and food intake.      Which of these factor(s) is most important? The investigators propose that by examining     dietary, physiological, genetic, and behavioral factors in an integrated fashion we will gain     insight into the obesity epidemic and identify the most important determinants of weight     gain. As a secondary aim, the investigators will identify a single parsimonious collection of     factors and develop strategies to mitigate the risks of developing obesity.   "
236667|NCT00945646|"     The objective of this study is to evaluate the efficacy of FST-201 compared to vehicle in the     treatment of acute fungal otitis externa. This trial is designed to enable filing of a New     Drug Application in support of FST-201 for the indication of acute fungal otitis externa.   "
236687|NCT00945919|"     This project will explore the safety and feasibility of performing a successful intravenous     patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral ER     Oxymorphone (extended release or OPANA ER) in the outpatient setting.   "
236688|NCT00945932|"     This study will measure the effect of repeat inhaled doses of GW870086X on lung function.   "
236689|NCT00945945|"     The primary purpose of this study is to determine if duloxetine 60 mg once daily (QD) reduces     pain severity in patients with osteoarthritis (OA) knee pain compared with placebo.   "
236668|NCT00945659|"     The incorporation of continuous glucose sensors (CGS) into management of type 1 diabetes in     adolescence could improve treatment outcomes. But, behavioral barriers may prevent     adolescents from enjoying optimal benefits from this new technology. This study will     randomize adolescents (11 to not yet 17 years old) with type 1 diabetes for at least 2 years     who are not achieving targeted HbA1c levels (> 7.5%) to continue in standard care (SC), to     add continuous glucose monitoring (CGM) to their care with appropriate education and medical     management (CGS) or to add CGM to their care as above but to also receive support and     assistance from a behavior therapist who will assist the patient and family in optimizing the     adolescents' therapeutic benefit from CGS (CGS+BT). A variety of outcomes will be measured,     including blood glucose control, quality of life, and CGS satisfaction and impact. An     enrollment criterion for this study is that the adolescent must have established consistent     care for type 1 diabetes at a Nemours Children's Clinic location either in Wilmington, DE,     Philadelphia, PA, Orlando, FL or Pensacola, FL for at least 12 months prior to enrollment in     the study. Adolescents treated elsewhere are not eligible to enroll in the study.   "
236669|NCT00945672|"     The purpose of this study is to determine whether multiple dose administration is safe and     well tolerated in patients with mild to moderate Alzheimer's Disease.   "
236670|NCT00945685|"     Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis     and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin     dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to collagen     modification, skin laxity and cellulite (dermis and hypodermis).      EndyMion has developed the Imagine™ system - Computerized Radiofrequency System for Skin     Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern     can be produced allowing to selectively heating one or more of the target tissues (epidermis,     dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be     targeted, creating enough thermal effect to induce collagen remodeling with no ablative     thermal damage in the epidermis or dermis. This post marketing study is intended for     evaluation of safety and efficacy of the Imagine™ system.   "
236671|NCT00945698|"     The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have     been associated with improved growth and development outcomes among infants in Ghana and     Malawi. Modified versions of such supplements have been developed to improve their nutrient     density and quality and to lower their costs. Such modified products have proven acceptable     to infants and their guardians in Malawi and Ghana. In the present trial, the investigator     aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the     investigators will test a hypothesis that LNS that does not contain milk promotes growth as     well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month     old infants in rural Malawi.   "
236672|NCT00945711|"     The purpose of this study is to analyze a chart audit of patients seen at Park Nicollet     Eating Disorder Institute (EDI) to identify and compare general characteristics of eating     disorders with type 1 diabetes patients to a matched eating disordered population without     type 1 diabetes, also seen at EDI.   "
236673|NCT00945724|"     This trial is a phase II non-comparative study aimed to determine the feasibility and     toxicity of the R-CHOP regimen in combination with intrathecal liposomal cytarabine and     systemic intermediate-dose methotrexate followed by loco-regional radiotherapy.   "
236674|NCT00945737|"     The objectives of the trial are to determine whether a non-commercial soy protein product,     consumed as part of a low-saturated fat diet, reduces low-density lipoprotein cholesterol     (LDL-C) concentrations in men and women with mild to moderate hypercholesterolemia, and     affects other aspects related biomarkers.   "
236675|NCT00945750|"     This study will determine whether the CT formulation of famotidine taken with and without     water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under     the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single     dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg     FCT with water.   "
236676|NCT00945763|"     To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction     surgery.   "
236677|NCT00945776|"     The purpose of this study is to compare the effects of three interventions on CPAP adherence.   "
236678|NCT00945789|"     In this prospective trial the investigators plan to study the efficacy of erythropoietin as a     therapeutic agent in neonates who suffer from brain injury following perinatal asphyxia.   "
236679|NCT00945802|"     The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in     the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug     Application in support of FST-201 for the indication of acute otitis externa.   "
236680|NCT00945815|"     RATIONALE: Monoclonal antibodies, such as epratuzumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Giving epratuzumab together     with cytarabine and clofarabine may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumab     together with cytarabine and clofarabine works in treating patients with relapsed or     refractory acute lymphoblastic leukemia.   "
236681|NCT00945841|"     This study is an annual trial for registration of inactivated split influenza vaccine with     strain composition for season 2009/2010.   "
236682|NCT00945854|"     A diet with the multiple beneficial characteristics of whole grains and, more in general, of     healthy cereals favorably influences glucose and insulin metabolism in subjects with     metabolic syndrome. Therefore, the aim of the study is to evaluate the long term effects of a     diet containing healthy cereals versus a control diet, on glucose and insulin metabolism in     subjects with metabolic syndrome.   "
236683|NCT00945867|"     The determination of the 2D6 genotype will enable us to determine the way flecainide is     metabolized by the liver. Some individuals are poor metabolizers and some individuals are     extensive metabolizers of the drug. This will also determine which patients will benefit from     the drug.   "
236695|NCT00946023|"     This phase II trial is studying how well giving fludarabine and cyclophosphamide together     with total-body irradiation and rituximab works in treating patients with B-cell lymphoma or     chronic lymphocytic leukemia who are undergoing an allogeneic (donor) bone marrow transplant.     The type of bone marrow transplant is a less intensive or mini transplant using a relative     as the bone marrow donor. The donated bone marrow stem cells may replace the patient's immune     system cells and help destroy any remaining cancer (graft-versus-tumor effect). Patients     undergoing this type of transplant often have more than one relative who could be a donor.     The trial is also studying a new way of choosing amongst possible donors which might improve     how the rituximab works.   "
236696|NCT00946036|"     -  Objective:             -  To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited,               India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100               mg tablet, under fasted conditions.        -  Study Design:             -  Single-dose, open-label, randomized two-way crossover.   "
236697|NCT00946049|"     Antibacterial Triclosan-coated suture material (VICRYL PLUS®, Ethicon) and non-coated     (VICRYL®) was compared for bacterial colonization after third molar extraction. Sutures were     removed postoperatively and adhered bacteria were investigated.   "
236698|NCT00946062|"     The purpose of this study is:        1. to develop a standardised orientation and mobility training (O&M-training) in the use of          an identification/symbol cane by older adults with low vision, and;        2. to evaluate this newly developed standardised O&M-training with respect to effectiveness          and feasibility in a randomised controlled trial.   "
236699|NCT00946088|"     Preterm delivery is the most common cause of infant morbidity and mortality in the United     States. Some women have episodes of preterm labor during their pregnancy which can be     temporarily stopped. These women, however, are at high risk for delivering before term. At     this time, we do not have sufficient evidence to use any medication to help prevent these     women from delivering early. Recently, preliminary studies have shown that progesterone may     help prevent some women at high risk for preterm delivery from delivering early. Our study     will investigate whether progesterone can help this specific group of women, women with     arrested preterm labor, deliver healthy infants at term.   "
236700|NCT00946101|"     The purpose of this study was to determine the safety and descriptive immunogenicity of the     H1N1 influenza vaccine in healthy children.   "
236701|NCT00946114|"     The purpose of this study is to provide sildenafil therapy to eligible adult patients with     pulmonary arterial hypertension (PAH) and to the patients who completed the A1481142 study     for the treatment of PAH in Poland. Only safety and tolerability data will be collected in     these patients.   "
236702|NCT00946127|"     The purpose of this study is to test and compare the efficacy of Endoscopic Third     Ventriculostomy with shunting of Cerebrospinal fluid (CSF)for treatment for patients of     Normal pressure Hydrocephalus.   "
236703|NCT00946140|"     The purpose of this study is to develop new image analysis method using Dynamic Contrast     Enhanced Magnetic Resonance Imaging (DCE-MRI) for ovarian cancer. MRI is not currently part     of the standard care for ovarian cancer. In this method, a contrast agent is used to make     ovarian cancer visible during imaging.   "
236704|NCT00946153|"     The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and     tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is     administered continually once daily in patients with advanced hepatocellular carcinoma.   "
236705|NCT00946166|"     The investigators are conducting a study to determine the effects of a cholesterol-lowering     medication, called simvastatin on pneumonia. People in the study will be in the hospital     because they have pneumonia. The people will also have a medical condition like heart     disease, diabetes, stroke or high cholesterol for which cholesterol-lowering medication has     been shown to prevent future disease and/or death but are not taking a cholesterol-lowering     medication when they go to the hospital. Some people will get treated with antibiotics only     and other people will get antibiotics and simvastatin while they are in the hospital. The     study will compare the effects the combination of simvastatin and antibiotics has on people     with pneumonia to treatment with antibiotics alone.   "
236706|NCT00946179|"     This study is in support of the annual application for the variation of the vaccine strains     for a marketing authorization.      Objectives:        -  To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split          virion, inactivated) Northern Hemisphere (NH) 2009-2010 formulation in two adult groups,          aged 18 to 60 years and aged 61 years or older.        -  To describe the safety of the influenza vaccine (split virion, inactivated) NH 2009-2010          formulation in both adult groups.   "
236707|NCT00946192|"     One aim of this study is to determine changes in body composition and hormones that     differentiate athletes who stop getting their periods versus those who continue to get their     periods and non-athletes. The second aim of this study is to determine whether transdermal or     oral estrogen (versus no estrogen) is effective in increasing bone density and improving bone     microarchitecture in adolescent athletes who are not getting their periods and are thus     estrogen deficient. The investigators hypothesize that transdermal estrogen will be more     effective than oral estrogen or no estrogen in improving bone health in amenorrheic     adolescent athletes.   "
236708|NCT00946205|"     The aim of the present prospective, double-blind, randomized study is to study whether     laparoscopic anterior mesh rectopexy is as good as laparoscopic posterior rectopexy with     respect to obstructive defecation afterwards.   "
236767|NCT00946972|"     This study will assess the safety, tolerability, pharmacokinetics (explores what the body     does to the drug), and pharmacodynamics (explores what a drug does to the body) of multiple     doses of JNJ-38431055 in volunteers with type 2 diabetes mellitus.   "
236709|NCT00946218|"     Dengue virus is an arbovirus transmitted by mosquitoes which causes significant morbidity and     mortality among children in tropical regions, especially in resource limited countries. The     objective of this protocol is to compare the sensitivity and specificity of clinical gestalt     and two rapid antigen tests for dengue virus and to compare the gene expression of leukocytes     in distinct dengue fever disease phenotypes module-based RNA microarray technology.   "
236710|NCT00946231|"     The HABIT clinical study is being performed to determine the benefit and optimal frequency     for at home testing of B-type natriuretic peptide (BNP) for heart failure patients following     hospitalization from decompensation. Subjects will be enrolled following hospitalization for     decompensated heart failure. Enrolled subjects will be trained on the use of the Triage Touch     meter for fingerstick BNP assessment; these subjects will then test their BNP levels daily     using the Triage Touch product for approximately 60 days.   "
236711|NCT00946244|"     The main purpose of this study is to extend the investigators' previous research to     longitudinally examine the effectiveness of three early intervention programs: usual care     program, clinic-based intervention program and home-based intervention program for very low     birth weight preterm children at 3 and 4 years of age. Normal weight full-term children will     also be included to serve as the reference group. Effectiveness assessments will include     child, parenting, and transactions measures. Child outcome measures will include health     status, growth, neurodevelopment and behavior; parenting outcome measures will include     parental stress, competence, efficacy and family support; transactions outcome measure will     include parent-child interaction procedures.   "
236712|NCT00946257|"     This study will assess the subcutaneous administration of otelixizumab to T1DM patients. The     study will provide safety, tolerability, pharmacodynamic and pharmacokinetic information     which will enable the identification of appropriate safe and well-tolerated subcutaneous     dosage regimens to be used in subsequent clinical studies. This study will consist of a     screening phase, followed by an in-house phase whereby otelixizumab will be administered to     cohorts that will be staggered at each dose level.   "
236713|NCT00946270|"     The goal of this clinical research study is to learn if CC-4047 (now called pomalidomide) and     prednisone can help to control MMM. The safety of this therapy will also be studied.   "
236714|NCT00946283|"     RATIONALE: Probiotics, such as Lactobacillus, may be effective in preventing infections in     patients with suppressed immune systems.      PURPOSE: This phase I trial is studying the side effects and how well giving enteral     nutrition, including Lactobacillus, works in preventing infections in patients undergoing     donor stem cell transplant for hematologic cancer or myelodysplastic syndrome.   "
236715|NCT00946296|"     The purpose of this study is to determine whether a brief course of SSKI (saturated solution     of potassium iodide) administered preoperatively provides any benefit in the surgical     management of patients undergoing thyroidectomy as definitive management of their Graves     Disease.   "
236716|NCT00946309|"     The investigators proposed to identify the biological effects of a high-sulforaphane broccoli     sprout extract in normal prostate tissue.      The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract     every other day will inhibit growth of prostate cancer cells.   "
236717|NCT00946322|"     The purpose of this study is to develop and test a couple-based treatment for Veterans with     an alcohol use disorder and post-traumatic stress disorder.   "
236718|NCT00946335|"     This phase I trial is studying the side effects and best dose of ABT-888 when given in     combination with temozolomide in treating young patients with recurrent or refractory CNS     tumors. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving ABT-888 together with temozolomide may kill more tumor cells.   "
236719|NCT00946348|"     The first aim of this study is to determine whether a brain reward center (BRC) deficiency in     patients with schizophrenia (SCZ) and cannabis use disorder (CUD) will be normalized when     patients are given cannabis or dronabinol. The second aim will serve to further assess the     effects of dronabinol on symptoms and medication side effects in this population.   "
236720|NCT00946361|"     The investigators will prospectively recruit 26 children with moderate - severe active Crohn     disease (PCDAI >30). Results will be compared to 26 patients in sustained remission (PCDAI     <10 and physician global assessment of remission over the previous 6 months) who are matched     for age and gender. Subjects will be studied at baseline and six months. The primary study     end-points will be leucine rate of appearance (a measure of protein breakdown) and IGF-1     levels.      This study will test the hypothesis that children with greater disease severity will have     worse longitudinal growth and protein catabolism. The investigators will also explore the     secondary hypothesis that children with Crohn disease have abnormal IGF-1 generation which is     linked to underlying inflammation and disease severity.   "
236721|NCT00946374|"     The purpose of this study is to improve the overall survival of Mantle-Cell-Lymphoma (MCL) by     a new concept of treatment with primary curative intention consisting of six courses of     immunochemotherapy followed by high-dose chemotherapy and autologous stem cell     transplantation (SCT) and HLA-identical allogenic SCT after a dose-reduced conditioning     regimen of total body irradiation (TBI) with 2 Gy and Fludarabine in younger patients with     primary Mantle-Cell-Lymphoma   "
236722|NCT00946387|"     To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under     fasting conditions.   "
236723|NCT00946400|"     The purpose of this study is to evaluate a scoring tool to help determine the presence of     Heparin Induced Thrombocytopenia (HIT), which is an adverse reaction to heparin. We     hypothesize that this scoring tool will be very useful in excluding patients who are     suspected of having HIT.   "
236724|NCT00946413|"     Cognitive behavioral therapy (CBT) is effective and CBT with parental involvement has     potential in preventing and treating adolescent depression. The purpose of this study was to     compare the short- and long-term effectiveness of CBT alone and CBT plus parental education     for community-based adolescents at risk for depression and suicide in Taiwan. It is     hypothesized that the CBT alone and CBT with parental education group are more effective than     the control group.   "
236725|NCT00946426|"     24 children (12 African-American, Hispanic, or American Indian, 12 Caucasian) previously     diagnosed with type 1 diabetes mellitus will participate in this pilot study to evaluate the     presence of hepatic and peripheral insulin resistance. The investigators will use this pilot     information to test the hypothesis that insulin resistance occurs in some children with type     1 DM, is secondary to underlying risk factors, and is responsible for increased insulin     needs. Methods will include a step-up hyperinsulinemic euglycemic clamp and infusion of the     stable isotope 6,6-[2H2]-glucose. Patient and parent interviews will be conducted to gather     information about nutritional intake, ethnicity, family history, and socioeconomic status.     The investigators will also measure inflammatory cytokines and free fatty acids to determine     whether they are associated with differences in insulin resistance among type 1 diabetes     mellitus patients.   "
237293|NCT00963911|"     RATIONALE: A screening questionnaire may help doctors plan better treatment for older     patients with cancer.      PURPOSE: This clinical trial is studying a questionnaire in screening older patients with     cancer.   "
236726|NCT00946439|"     The purpose is to evaluate the effects of adding a wheel assisted running training (WART) to     a conventional mixed physical activity training (CT) program on walking and gross motor     function in trained children with cerebral palsy (CP).      Method entails recruiting thirty children with CP (16 females, 14 males), with mean (SD) age     11.8 (3.5) and training experience 3.4 (3.5), years were assigned to either WART or CT     groups. The energy Expenditure Index (EEI), the Gross Motor Function Measure 66 (GMFM),     self-selected and fast walking velocity (SSV and FV, respectively), and cadence are     administered by a trained physical therapist. The intervention period is six months, with two     sessions per week.   "
236727|NCT00946452|"     To characterize the level of asthma control and patient satisfaction amongst diagnosed asthma     sufferers who are currently receiving Symbicort Maintenance and Reliever Therapy (SMART) in     Malaysia.   "
236728|NCT00946465|"     To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under fasting     conditions.   "
236729|NCT00946478|"     The purpose of this study is to determine the effect of topical pimecrolimus on the immune     system by assessing the levels of antimicrobial peptides in the skin of patients with eczema.     It is hypothesized that pimecrolimus applied topically will repair the body's immune system     in patients with eczema by increasing antimicrobial peptides.   "
236730|NCT00946491|"     To demonstrate the relative bioequivalency of generic Haloperidol tablets versus Haldol in     normal volunteers.   "
236731|NCT00946504|"     To demonstrate the relative bioequivalency comparing Geneva's 10 mg Glipizide tablets to     Roerig's 10 mg Glucotrol tablets.   "
236732|NCT00946517|"     This study will test the hypothesis that certain parenting styles are associated with greater     non-adherence to therapy in children and teens with type 1 diabetes. To test their     hypothesis, the investigators will use standardized and validated questionnaires for parents     and children to determine: parenting styles (the investigators will measure parental     strictness, parental attachment, and parental monitoring), parent ability to cope with     stress, parent comfort with the parenting role, parent and child level of depression and     parent perception of financial resources. The investigators will also measure parent and     child's perception of the child's underlying temperament and parent-child conflict. The     investigators will correlate these findings with both parent and child subjective measures of     adherence to therapy. The investigators will also obtain objective measures of therapy     adherence including: HbA1c, number of hospitalizations for diabetes ketoacidosis and number     of missed outpatient appointments. These measures will be correlated with our other findings.   "
236733|NCT00946530|"     The aim of this study is to demonstrate the efficacy of timed exposure to bright light for     the treatment of disturbed nighttime sleep and daytime wake in community-dwelling dementia     patients and their caregivers, and to determine if there are genetic relationships between     memory problems and sleep problems   "
236734|NCT00946543|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation     therapy in treating patients with prostate cancer.   "
236735|NCT00946556|"     Herpes simplex virus type 2 (HSV2), the most common cause of genital herpes, increases a     woman's risk of HIV acquisition from 3-6 fold, perhaps because HSV2-infected women have     increased numbers of HIV target cells (CD4 T cells and dendritic cells) in the cervical     mucosa. However, recent clinical trials showed no impact of HSV2 suppression on HIV     acquisition rates. The reasons for this negative result are unclear. The investigators     propose to examine the effect of valacyclovir (a widely used herpes medication) treatment on     cervical immunology and HIV target cells in the cervix. The study will take the form of a     randomized, double-blind, placebo-controlled crossover trial. Primary endpoints will be (1)     the number of CD4 T cells on a cervical cytobrush and (2) the number of immature dendritic     cells per cervical cytobrush.   "
236736|NCT00946569|"     The purpose of this study is to evaluate the safety and effectiveness of once daily oral     administration of JNJ-39758979 in the treatment of adults (18 to 65 years of age) with     persistent asthma.   "
236737|NCT00946582|"     The purpose of this study is to explore the therapeutic effects of Barkley's parenting     management program for Taiwanese school-aged children with ADHD. The investigators     hypothesized that Barkley's parenting management program might empower the parents'     competence to manage their school-aged children's ADHD-related disturbing behaviors as its     previously-proven effects for parents and their preschool-aged children with ADHD.   "
236738|NCT00946595|"     A 2-year multicenter, phase II/III, randomized active-controlled trial to evaluate the     efficacy and tolerance of two maintenance strategies in HIV-1 infected patients with HIV RNA     below 50 copies/mL : a monotherapy with lopinavir/ritonavir or a single-tablet triple therapy     (EFV/FTC/TDF).   "
236739|NCT00946608|"     To demonstrate the relative bioavailability study of Loratadine 10 mg tablets.   "
236740|NCT00946621|"     To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under     non-fasting conditions.   "
236768|NCT00946985|"     The study will assess the use of paliperidone palmitate compared with oral risperidone in     delaying time to relapse in patients recently diagnosed with schizophrenia who are at high     risk of relapse.   "
236741|NCT00946634|"     The ozone therapy has been coming up as a new therapeutic modality. Medicine has been     practicing since XIX century and counted great results. It is indicated for the treatment of     260 different pathologies. The researches in Dentistry has showed promising results,     indicating a wide spread action in whole dental specialties. The great oxidative power of     ozone provides a great antimicrobial effect and it increases the adenosine triphosphate (ATP)     synthesis that can be considered as a general improvement of the cell metabolism, which can     potentize the repair process. Thus, these facts justify the present study which will assess     the increase of speed of apical periodontite repair.   "
236742|NCT00946647|"     The purpose of this randomized, two-arm, open-label expansion phase study is to collect     preliminary efficacy data of panobinostat at the recommended phase II dose (RPIID) level in     combination with azacytidine (5-Aza) versus an active control arm 5-Aza alone. This     randomized phase II part allows also collecting safety data of panobinostat in combination     with 5-Aza in comparison to single-agent 5-aza.   "
236930|NCT00956501|"     The purpose of this pilot study is to characterize changes in postural orientation and     equilibrium in early diagnosed ALS patient. The investigators plan to cross validate the use     of a standardized test of equilibrium (EquiTest, Computerized Dynamic Posturography - CDP) in     early diagnosed ALS patients.   "
236743|NCT00946660|"     This research deals with behaviors that are part of drug dependence. The purpose is to study     how certain factors, including money, the amount of drug available, and the amount of work     effort, affect cocaine drug choice. Specifically, we will examine the effects of two     issues/factors. The first is how hard individuals are willing to work to obtain a drug; the     second is how much drug would individuals choose instead of money, when the amount of     probability of money is predictable or unpredictable.   "
236744|NCT00946673|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat     given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer     (NSCLCA) brain metastases in patient with 1-4 lesions.   "
236745|NCT00946686|"     To demonstrate the relative bioavailability, parallel study Of Leflunomide 20 mg tablets     under fasting conditions.   "
236746|NCT00946699|"     The primary objective of this study is to evaluate the safety and tolerability of     intravenously administered MEDI-551 over escalating single doses in adult subjects with     Scleroderma   "
236747|NCT00946712|"     This randomized phase III trial studies carboplatin and paclitaxel to compare how well they     work with or without bevacizumab and/or cetuximab in treating patients with stage IV or     non-small cell lung cancer that has returned after a period of improvement (recurrent). Drugs     used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that     tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and     interfering with a protein on the surface of the tumor cell that is needed for tumor growth.     It is not yet known whether giving carboplatin and paclitaxel are more effective with or     without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer.   "
236748|NCT00946725|"     To demonstrate the relative bioavailability of atenolol tablets, 100 mg.   "
236749|NCT00946738|"     The effect of deep oscillation and biofeedback on Raynaud`s phenomenon secondary to systemic     sclerosis (SSc) remains to be determined. A prospective randomized controlled pilot study was     performed in SSc patients receiving either deep oscillation, biofeedback thrice a week for     four weeks or were randomized to the control group.   "
236750|NCT00946751|"     To demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750     mg Levetiracetam tablets in healthy adult volunteers under fasting conditions.   "
236751|NCT00946764|"     To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50     mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.   "
236752|NCT00946777|"     The primary objective is to determine if there is a correlation between reductions in corneal     staining and improvements in corneal barrier function.   "
236753|NCT00946790|"     To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.   "
236754|NCT00946803|"     Patients receiving treatment for advanced cancer often experience co-occuring pain, fatigue,     and sleep disturbance that are not relieved with medications. Brief cognitive-behavioral     coping strategies such as relaxation or imagery have been shown to be useful for these     symptoms individually and may be effective for the cluster of co-occuring pain, fatigue, and     sleep disturbance. Because single cognitive-behavioral strategies don't work equally well for     all persons, providing training in multiple cognitive-behavioral strategies is necessary.     However, oncology nurses report having insufficient time and are often not available to     deliver the interventions exactly when patients experience symptom exacerbation. This     application proposes a patient-controlled cognitive-behavioral (PC-CB) intervention, using an     MP3 player to deliver recorded cognitive-behavioral strategies. The PC-CB intervention would     allow patients to select from a variety of cognitive-behavioral strategies based on their     personal preferences, and facilitate self-administration of those strategies at whatever time     and place the symptoms occur, without increasing burden on nursing staff. Primary aims are     (1) to explore acceptability and patterns of use of the recorded cognitive-behavioral     strategies and (2) to pilot test efficacy of the PC-CB intervention compared to a waitlist     control.   "
236769|NCT00946998|"     This is a randomized double-blinded placebo-controlled trial to see if treatment with     sertraline as compared with placebo tablets will improve depression symptoms in patients with     chronic kidney disease who have not yet started dialysis or received a kidney transplant. The     investigators will also investigate whether sertraline treatment will improve quality of life     and whether it is safe to use in patients with kidney disease. The study subject will be     randomly assigned to take either sertraline or a placebo tablet for 12 weeks.   "
236770|NCT00947011|"     This research is being done to evaluate the effect of glucagon-like peptide-1 (GLP-1, a     naturally occurring hormone) on insulin release and to examine whether there is extra insulin     release when GLP-1 is not allowed to be rapidly inactivated.   "
236771|NCT00947024|"     To demonstrate the effect of food on the bioavailability of Glipizide.   "
236755|NCT00946816|"     Diseases characterized by abnormal low and high body weight are common in the community and     are associated with significant morbidity, mortality and health care related costs.      Genetic, dietary, social and psychologic factors all play an important part in these     conditions; however the central role of gastrointestinal (GI) function and the control of     nutrient delivery to the small bowel has not been well described in health or disease.      We propose that the GI response to feeding varies inversely with body weight. This hypothesis     predicts that as body weight increases, the response to a given meal decreases in terms of     motility, neurohormonal feedback, sensation and satiety. This provides an attractive     explanation for why thin individuals stop eating after a small amount of food (i.e. limited     gastric relaxation, rapid gastric emptying, powerful nutrient feedback with early     satiety)and, conversely, why obese patients continue to eat even after nutritional     requirements have been met (i.e. large gastric relaxation, slow gastric emptying, weak     nutrient feedback with delayed satiety).      This project will apply MRI and Breath Tests to assess GI motility, hormonal feedback,     visceral sensation and satiety in patients with pathologically low (anorexia nervosa) and     high (morbid obesity) body weight and in healthy, normal weight controls.      Participants will include: Group A: normal weight, healthy volunteers (n=24: BMI: 18.5-24.9     kg/m2) Group B: patients with anorexia nervosa (DSMIV criteria and BMI: <16 kg/m2) B1:     anorexia restricting type (n=12-20 over 2 years) and B2: anorexia bulimia type (n=20 over 2     years) Group C: patients with morbid obesity (BMI: 30-40 kg/m2) C1: obese (n=20 over 2 years)     and C2: obese with DM type II (n=20 over 2 years).      Two studies will be performed        1. Cross-sectional study: The effects of a test meal on GI motility, hormonal feedback,          visceral sensation and satiety in healthy controls and in patients with anorexia and          obesity        2. Longitudinal study: The effects of dietary treatment (i.e. weight change) on GI          motility, hormonal feedback, visceral sensation and satiety in patients with anorexia          and obesity   "
236756|NCT00946829|"     The aim of the observational study is to ascertain the degree of blood pressure control in     the early-morning hours after 8 weeks of treatment with     Telmisartan/Telmisartan+Hydrochlorothiazide and during 44 weeks of follow-up, in patients     with hypertension using home blood pressure measurements.   "
236757|NCT00946842|"     The purpose of this study is to determine the relative oral bioavailability (the extent to     which a medication or other substance becomes available to the body as compared with another     form of medication or other substance) of TMC207 after single-dose oral administration of the     Phase II clinical study tablet formulation, and a newly developed tablet formulations, under     fed (with food) and fasted (without food) conditions.   "
236758|NCT00946855|"     Repeated blood sampling within a regular soccer season of German first league clubs shall     serve to define soccer-specific reference values for routine parameters determined from     venous blood. It was hypothesized that only for a minor number of parameters common reference     values will have to be adapted for soccer players during their competitive season.   "
236759|NCT00946868|"     Metabolic syndrome, a group of cardiovascular risk factors related to insulin resistance, is     a major determinant of cardiovascular mortality.      Intermittent claudication is a symptom of an early stage of atherosclerosis.      The aim of this study is to determine the prevalence of the metabolic syndrome in patients     with intermittent claudication and its correlation with age, gender, localization of arterial     obstruction and association with coronary artery disease.   "
236760|NCT00946881|"     The aim of this study is to determine the optimal treatment conditions (WST11 dose and light     energy dose) to achieve ablation in one lobe of the prostate and to evaluate the safety and     quality of life of WST11 medicated Vascular-Targeted Photodynamic therapy (VTP) in men with     localized prostate cancer.   "
236761|NCT00946894|"     The aim of this three-arm randomized study was to evaluate results of different thyroid     resection modes among patients with bilateral multinodular non-toxic goiter, with special     emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.   "
236762|NCT00946907|"     Treatment of pericarditis largely remains empirical due to the relative lack of randomized     controlled trials. Nevertheless, some recommendations have been formulated to guide     management and follow-up of acute pericarditis. Aspirin or an NSAID at medium to high dosages     is the mainstay of treatment. Optimal length of treatment is not established.      PERICARDITE is a French multicentric placebo controlled double blind randomized trial     assessing efficacy of a brief treatment based on Aspirin (4 days) versus a longer treatment     (21days) in treating a first episode of probably idiopathic acute pericarditis. It is a non     inferiority trial.      Exclusion criteria are: diseases known to cause pericarditis: (recent myocardial infarction,     autoimmune disease, postpericardiotomy syndromes, connective tissue disease, tuberculosis,     neoplastic disease).      Primary endpoint is: 30 days recovery defined as the normalization of all clinical and     paraclinical initial abnormalities.      Secondary endpoint is: 6-month recurrence.   "
236763|NCT00946920|"     A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of     degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in     patients with prostate cancer.   "
236764|NCT00946933|"     Approximately 30% of people aged 65 years and older experience breathlessness (perceived     respiratory difficulty) during daily activity. The main causes of increased breathlessness in     the healthy elderly are poorly understood and are the main focus of the proposed study. Some     possible contributing factors include abnormalities in the control and/or mechanics of     breathing. To evaluate these possible contributory factors, the investigators will compare     ventilatory and perceptual responses to: 1) exercise, 2) increased levels of inspired carbon     dioxide, and 3) reduced levels of inspired oxygen under strictly-controlled experimental     conditions where the investigators increase or decrease breathing requirements by altering     dietary salt intake in healthy 40-80 year old men and women.      Exercise and rebreathing tests will be performed at baseline and at the end of each 3 day     treatment period. Breathlessness intensity will be measured and compared at a standardized     work rate, ventilation or end-tidal PCO2 during these tests.   "
236765|NCT00946946|"     This study aims to compare azathioprine versus mesalazine tablets for the prevention of     clinical relapse in postoperative Crohn's disease (CD) patients with moderate or severe     endoscopic recurrence.   "
236766|NCT00946959|"     The real impact of cardiac surgery and coronary angioplasty remains to be clarified and,     where appropriate, the influencing factors in a way beneficial or deleterious remain to be     identified.      The identification of such factors could make even faster screening, prevention and therefore     open therapeutic prospects for those patients.      The objective of the study is to constitute a prospective cohort to assess the occurrence of     cognitive decline after cardiac surgery (200 patients) and coronary angioplasty (200     patients) using the scale Dementia rating scale (DRS) of Mattis. In addition, the     investigators will identify factors that influence positively or negatively, the occurrence     of such a cognitive decline. The study based on a systematic monitoring of clinical,     biological, imaging and pharmacological factors and, to correlate the respective influence of     these factors on the incidence of cognitive decline.   "
236772|NCT00947037|"     An extension of study IN 09 004 testing the long term safety of the Accordion Pill     Carbidopa/Levodopa (AP-CD/LD)   "
236778|NCT00947115|"     Infection with human papillomavirus (HPV) has been clearly established as the necessary cause     of cervical cancer. This study is designed to evaluate the long-term immunogenicity and     safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the     first dose of HPV vaccine (Month 0) in primary study NCT 00196937. This protocol posting     deals with objectives & outcome measures of the extension phase from Year 5 to Year 10. The     objectives & outcome measures of the primary phase and extension phase up to year 4 are     presented in a separate protocol posting (NCT 00196937).   "
236779|NCT00947128|"     To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under     non-fasting conditions.   "
236780|NCT00947141|"     This study aims to determine: a) whether those patients with 'low level' viral load results     (between 200 and 3,000 copies/ml) could be monitored as opposed to starting preemptive     therapy with valganciclovir, ganciclovir and/or foscarnet; b) whether those patients with     'high level' viral load results (above 3,000 copies/ml) could stop preemptive therapy     earlier, thus maximising the benefits of therapy and minimising its risks.   "
236781|NCT00947154|"     No medication has been reliably shown to benefit those suffering from trichotillomania     (compulsive hair pulling). The current study proposes to evaluate the effectiveness of the     medication aripiprazole for treatment of trichotillomania (TTM). Patients will take a     gradually increased dose of the medication in an open-label study to see whether it relieves     hair-pulling urges, decreases hair pulling behavior and is well tolerated.   "
236782|NCT00947167|"     To determine objective response rates (RR) by RECIST guideline version 1.1 for all patients     treated with this strategy consisting of initial therapy with pertuzumab as a single agent     and then addition of erlotinib for those who have stable disease or progressive disease at     three months (Simon design).   "
236783|NCT00947180|"     This study has been completed. The following is a brief description of the aims, methods, and     results of the study:      Previous small studies suggest that chronic proctalgia (chronic recurring pain in the anal     canal or rectum), which is also called levator ani syndrome, can be treated with biofeedback     to teach relaxation of pelvic floor muscles, or electrogalvanic stimulation (electrical     stimulation to relax muscles), or massage of pelvic floor muscles. The aim of this study was     to compare the effectiveness of these three treatments, to determine how they work     physiologically, and to identify which patients are most likely to benefit.      Methods: Subjects had to meet the diagnostic criteria for chronic proctalgia and to report     pain at least once a week. They had to also be free of medical or psychiatric disorders that     could explain their chronic proctalgia. Patients qualified to enter the study were separated     into two groups based on whether they reported tenderness when the examining physician     pressed on the levator ani muscles of the pelvic floor. All 157 patients who were enrolled     received 9 sessions of psychological counseling plus biofeedback or electrogalvanic     stimulation or massage. The results of treatment were assessed at 1, 3, 6, and 12 months     after the end of treatment.   "
236784|NCT00947193|"     Hemophilia A (HA) and hemophilia B (HB) are inherited bleeding disorders caused by mutations     in the gene for factor VIII (FVIII) and factor IX (FIX), respectively. These proteins are     essential for blood clotting. The lack of FVIII/FIX can produce bleeding episodes that cause     damage of the bone, muscles, joints, and tissues. A specific type of mutation, called a     nonsense (premature stop codon) mutation, is the cause of the disease in approximately 10-30%     of patients with hemophilia and results in severe manifestations. Ataluren (PTC124) is an     orally delivered, investigational drug that acts to overcome the effects of the premature     stop codon, potentially enabling the production of functional FVIII/FIX. This study is a     Phase 2a trial evaluating the safety and efficacy of ataluren in patients with HA or HB due     to a nonsense mutation. The main purpose of this study is to understand whether ataluren can     safely increase FVIII/FIX activity levels.   "
236785|NCT00947206|"     This proposed project seeks to expand understanding of what constitutes a lay health worker     (LHW), how those characteristics determine the effectiveness of LHWs as health educators on     colorectal cancer (CRC) screening, and the relationship of those characteristics to a     particular community and culture. Using quantitative and qualitative methods and a     community-based participatory research (CBPR) approach, the project will develop and     implement a group randomized controlled trial to evaluate LHW effectiveness in promoting CRC     screening among Chinese Americans age 50 to 75 with a pilot component to evaluate the role of     Traditional Chinese Medicine (TCM) healers as health educators.      The investigators will conduct focus groups with community participants to revise training     materials developed in a prior pilot project. The investigators will also conduct     ethnographic observations of TCM healers and focus groups with their clients to refine the     training materials. The investigators will recruit 26 LHWs to be assigned to the intervention     arm and 26 to the comparison arm. The LHWs will each recruit 12 participants from their     social network for a total of 312 participants in each arm. The intervention group     participants will be exposed to 2 LHWO sessions and 2 telephone calls aimed at increasing     their CRC screening receipt. The comparison group will receive a bilingual CRC brochure as     well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO     session on CRC screening. Effectiveness of the intervention will be measured by     pre-intervention and post-intervention surveys of community participants' CRC screening     behaviors, with validation of self-reports. An additional 10 TCM healers will also     participate as LHWs. They will each recruit 12 participants for LHWO. There will be extensive     ethnographic observations as well as post-intervention focus groups of LHWO activities, LHWs,     and LHWO participants to assess the factors that contribute to effective LHWO.      The primary hypothesis is that the increase in the proportion of participants who report ever     having had a CRC screening test in the experimental group (LHWO about CRC) will be greater     than the increase in the comparison group (nutrition education + CRC brochure).   "
236786|NCT00947219|"     The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks     compared to baseline measurements.   "
236787|NCT00947232|"     This study compares two approaches to helping people who are aging with MS or SCI and are     experiencing depressed mood to become more physically active. The study is carried out     entirely by telephone. There is no need to travel and participants may reside anywhere within     the United States. We will examine the effects of the intervention on overall physical     activity, mood, pain, fatigue and general health. Participants will complete surveys over the     phone throughout the study and wear an activity monitor 3 times. The study is 6 months in     length and participants may receive up to $120 for their time and effort.   "
236788|NCT00947245|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics     following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.   "
236789|NCT00947258|"     The stretching is performed within sports to improve muscle performance and prevent muscle     injury. However, recent studies are contradictory with common practice. Then raised the     possibility that stretching before physical activity performed can decrease the muscle     performance of healthy subjects.   "
236790|NCT00947271|"     This study will determine whether showing an educational DVD to people at sexually     transmitted infection clinics can reduce incidence of new infections and risky sexual     behaviors and improve overall health.   "
236791|NCT00947284|"     In previous clinical studies of post-surgical pain the investigators found that nalbuphine     (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose     naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was     particularly true in men. The purpose of this study is to find out if nalbuphine combined     with naloxone is more effective in relieving experimentally produced pain than either drug     alone. A second reason for this study is to find out if study medications work more     effectively in women or in men. Subjects will come to the University of California at San     Francisco (UCSF) Clinical Research Center (CRC) for 4 study visits. The first visit will be a     2-hour screening to assess the subject for study eligibility. During the other three visits,     the investigators will use a thermal stimulating device to produce temporary, non-injurious     skin sensitivity that subjects will feel as painful. Changes in pain will be measured     following the intravenous (i.v.) administration of study drugs. Three drug combinations will     be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2)     naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug     combinations will be administered in random order; all subjects will receive all three     combinations.   "
236792|NCT00947297|"     This was a long-term safety study HPN-100 in urea cycle disorder (UCD) subjects. Subjects     were assessed regularly for safety and control of their venous ammonia. Hyperammonemic events     were characterized with respect to contributing factors, such as intercurrent illness, diet,     and noncompliance with medication.   "
236793|NCT00947310|"     This study will assess the impact of higher rate cutoffs and longer delays than standard     programming on inappropriate therapy in primary prevention ICD and CRT-D patients.   "
236794|NCT00947323|"     This is a randomized clinical trial, double-blind, placebo controlled, to verify if     simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any     cardiac disease.It is hypothesized that the simvastatin can improve the endothelial function,     improving the nitric oxide liberation in corpora cavernosa of the penis, resulting in     improvement of erection.   "
236795|NCT00947336|"     Background: Spontaneous bacterial peritonitis (SBP) is a serious complication in patients of     cirrhosis with ascites and may occur despite antibiotic prophylaxis. Small bowel dysmotility     and bacterial overgrowth have been documented to be related to SBP. Aims: To investigate     whether addition of prebiotic plus probiotics (synbiotics) to norfloxacin enhances the     efficacy of norfloxacin in prevention of SBP in high risk patients with ascites.      Methods: A prospective, double blind, randomized controlled trial was conducted in     consecutive high-risk cirrhotic patients with ascites who had either recovered from an     episode of SBP (secondary prophylaxis) or who never had SBP but were at high risk for     development of SBP (low ascitic fluid protein or serum bilirubin ≥2.5 mg/dL; primary     prophylaxis). Norfloxacin 400 mg once daily with synbiotic capsules (Streptococcus faecalis     JPC 30 million, Clostridium butyricum 2 million, Bacillus mesentericus JPC 1 million,     Lactobacillus sporogenes 50 million spores) 2 t.i.d. (group I) or norfloxacin 400 mg once     daily with placebo (group II) was given and occurrence of SBP within a period of 6 months     (primary endpoint) or side-effects of therapy and mortality (secondary endpoints) were     recorded. Every patient received IV albumin to maintain a serum albumin level of >3.2 g/dl.     SBP was treated with intravenous antibiotics with albumin.   "
236796|NCT00947349|"     The current Standard of Care (SOC) for chronic HCV infection, which is pegylated     interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is     effective in only part of the patients and is often associated with severe adverse effects     leading to discontinuation of treatment and dose modifications.      A number of compounds with direct activity are currently under clinical development, incl. BI     201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to     the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see     how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN     and RBV in HCV infected patients   "
236797|NCT00947362|"     The aim of the randomized double blind trial with 134 patients presenting old world cutaneous     leishmaniasis is:        -  to evaluate the clinical efficacy of electro-thermo-cauterisation (ETC) followed by          moist wound treatment versus ETC followed by moist wound treatment plus 0.05 %          pharmaceutical chlorite that has been used in three European countries (Germany, Austria          and Switzerland) in wound care management for more than 20 years;        -  to judge whether early wound care management would present a viable improvement to the          actual anti-parasitic treatments mostly neglecting the chronic wound problem and to          evaluate its long-term effect on immunity through relapse control 6 months after wound          healing.   "
236798|NCT00947375|"     The purpose of this study is to determine the effect of lamotrigine augmentation of     Haloperidol decanoate in the treatment of Resistant Schizophrenia predominantly by verbal     resistant hallucinosis: A randomized, double-blind, placebo-controlled, study.      Nadir A.Aliyev & Zafar N.Aliyev      Central Mental Clinic for Outpatients of Baku city of Azerbaijan Republic      Abstract:      OBJECTIVE: The current paper reports on a double-blind, randomized study of the role of     lamotrigine as an augmentation agent to haloperidol decanoate in the treatment of out     patient's schizophrenia with verbal resistant hallucinosis.   "
236799|NCT00947388|"     This phase I trial is studying the side effects and best dose of alemtuzumab when given     together with bendamustine hydrochloride in treating patients with relapsed chronic     lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that did not respond to     fludarabine phosphate. Drugs used in chemotherapy, such as bendamustine hydrochloride, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, can also block     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.     Others find cancer cells and help kill them or carry cancer-killing substances to them.     Giving bendamustine hydrochloride together with alemtuzumab may kill more cancer cells.   "
236800|NCT00947401|"     The objective of the present study is to describe the current practice of postoperative fluid     management in the Post Anesthesia Care Unit (PACU) of the Shaare Zedek Medical Center,     Jerusalem, Israel.   "
236966|NCT00956982|"     The purpose of this study is to analyze the efficacy and safety of a combination therapy of     pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients     (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65     years old).   "
236801|NCT00947414|"     Hypothesis: The combination of extracorporeal shockwave and a daily gluteal muscle strength     programme is superior to the gluteal muscle strength programme alone in cellulite.      Study design: Randomized-controlled trial      Analysis: Intention-to-treat      Outcome parameters: a) Photo, b) Nürnberger Score, c) circumference measurements, d)     capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow      Intervention: Extracorporeal shock wave for six sessions with 2000 impulses at both gluteal     and thigh regions plus a specific gluteal strength exercise training      Follow-up: 12 weeks   "
236802|NCT00947427|"     Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1     class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the     bioactivity of this pro-inflammatory cytokine.      The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical     trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous     injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive     standard intensive diabetes treatment with insulin and dietary management.      Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12     injections over one year.      All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up     until study end. Enrollment is expected to occur over two years.   "
236803|NCT00947440|"     The purpose of this study is to assess the bioavailability, safety, tolerability and     pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended     in liquid.   "
236804|NCT00947453|"     Matrix metalloproteinases (MMPs) are a group of 24 zinc containing enzymes in man. These     enzymes were originally described as cleaving extracellular matrix (ECM) substrates with a     predominant role in ECM homeostasis, but it is now clear that they have much wider     functionality. An imbalance between MMP activity and that of their inhibitors (tissue     inhibitors of metalloproteinases, TIMPs) is considered to play a critical role in the     synthesis or degradation of the extracellular matrix of the airway architecture which results     in fixed airflow obstruction in both asthma and chronic obstructive pulmonary disease (COPD).     Using quantitative real time polymerase chain reaction (RT-PCR) the investigators have     identified a difference between the level of steady state mRNA for MMP-9, MMP-14 and MMP-2 in     2 patients with asthma compared to 4 healthy controls using our method. However the     investigators require further refinement of the process in order to optimise RNA quality and     to evaluate the effect of montelukast across the entire family of MMPs and their inhibitors     (TIMPs).   "
236805|NCT00947466|"     The purpose of this study is to characterize the pharmacokinetics and tolerability of     buprenorphine patches in children who require opioid pain relief for moderate to severe mouth     pain.   "
236806|NCT00947479|"     Obstructive sleep apnea (OSA) is a frequently underdiagnosed condition that has emerged as an     increasing medical problem with important social and financial implications worldwide. OSA is     a well established risk factor for systemic hypertension myocardial infarction or stroke and     it has been documented that blood pressure rises in a very consistent fashion during apneic     episodes. The incidence of the episodes of apnea during sleep causes repeated subclinical     acute kidney injuries (AKI) contributing to the development of CKD. One of the mechanisms     responsible for AKI might be endothelial injury followed by an increase of central aortic     pressure.   "
236807|NCT00947492|"     PBMNC DNA is considered a limit above which patients will develop EBV associated post     transplant lymphoproliferative disorder.      we showed that methotrexate tended to decrease EBV load over time, but this did not reach     significance and that TNFa inhibitors did not significantly modify EBV load over time.      Our objective is to monitor Epstein Barr Virus load over time in patients with Rheumatoid     arthritis under Orencia* (abatacept) or RoActemra* (tocilizumab), to detect possible     immunosuppression associated EBV dysregulation, as seen in post transplant     lymphoproliferative disease.   "
236808|NCT00947505|"     The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 7 Beam     model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment     is applied as directed.   "
236809|NCT00947518|"     The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine     affects skin condition, temperature, and bacterial colonization in stable preterm (28-36     weeks gestational age) low birth weight (1001-2000 g) infants admitted in a health facility.   "
236810|NCT00947531|"     This clinical trial was performed to assess the clinical efficacy and safety of two 4 week     treatment courses of daily intravenous administration of Cerebrolysin (20mL [milliliter] IV     [intravenous] per day). The study was performed as prospective, randomised, double-blind,     placebo-controlled, parallel group, multicentre study with 2 study groups.      Group 1: 20 mL Cerebrolysin and 100 mg (milligram) acetylsalicylic acid Group 2: Placebo     (0.9% NaCl [sodium chloride]) and 100 mg acetylsalicylic acid The study drug was given once     daily by intravenous infusion (20ml in 250ml saline solution) for 4 weeks on five consecutive     days per week. This treatment regimen was repeated after a two-month treatment-free interval.     Acetylsalicylic acid was given orally, once daily throughout the study duration of 24 weeks.      Altogether five clinical evaluation visits at Baseline (day 0) and at week 4, 12, 16, and 24     were necessary.   "
236811|NCT00947544|"     Protocol HPN-100-005 was the first study of HPN-100 in pediatric subjects with urea cycle     disorders (UCDs) and was a fixed-sequence, open-label, switch over study of HPN-100 with a     long-term (12 month) safety extension designed to assess the safety of HPN-100 and to     prospectively assess its ability to control blood ammonia as compared with Sodium     Phenylbutyrate (NaPBA). Upon DSMB review of the first ten subjects who completed the switch     over part of the study, and with DSMB approval, up to an additional 20 subjects were enrolled     into the safety extension part of the study. HPN-100 is a triglyceride that has a similar     mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of     HPN-100 (~17.4mL) delivers an equivalent amount of PBA to 40 tablets of NaPBA.   "
236812|NCT00947557|"     This study will evaluate the safety and efficacy of dutogliptin in patients with type 2     diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without     metformin.   "
236813|NCT00947570|"     This study will examine the effects of cognitive behavioral therapy on brain function in     people with anxiety disorders.   "
236814|NCT00947583|"     This study is being conducted to determine the percentage of patients with solid spinal     fusions after being treated with Osteocel Plus in a TLIF procedure. Due to the unique     processing conditions, Osteocel Plus retains a high concentration of stem cells in     conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with     Osteocel Plus will be comparable to published data for autograft. The Osteocel product family     has already been used in approximately 15,000 cases worldwide.   "
236815|NCT00947596|"     MicroDose Defense Products, LLC is developing an atropine dry powder inhaler (ADPI). This     pilot study compares the pharmacokinetics (PK) of inhaled dry powder atropine as delivered by     the ADPI to atropine delivery from the AtroPen autoinjector.   "
236816|NCT00947609|"     The study is a prospective study to improve the diagnosis and management of latent TB in     HIV-infected and HIV uninfected children in Thailand. The objectives are to assess the     sensitivity and specificity of IGRAs (T-Spot®.TB, a T-cell-based assay, and QuantiFERON®-TB     Gold In-tube, a whole blood assay), TST, and a refined symptom-based questionnaire in     diagnosing latent TB in 166 HIV-infected and HIV uninfected children in Thailand, and to     evaluate the influence of age, nutritional and immune status on children's response to the     IGRAs. These children will be screened for TB with a detailed TB contact history,     symptom-based questionnaire, physical examination, TST, chest radiograph (and abdominal     ultrasound for those with abdominal symptoms), IGRAs, and clinical specimens for acid fast     bacilli stain and culture. A diagnostic algorithm will be generated using the combination of     test modalities with the highest sensitivity and specificity results.   "
236817|NCT00947622|"     The aim of this study is to investigate whether transcranial direct current stimulation is     effective in the treatment of fibromyalgia related pain. The study provides a placebo arm and     the design is a cross-over design.   "
236818|NCT00947635|"     The purpose is to investigate possible mechanisms of increased blood lipid levels following     transplantation, and also to see if a comprehensive dietary intervention is effective in     reducing blood lipid levels in post-transplant patients.   "
236819|NCT00947648|"     The purpose of this study is to evaluate the infection rate of leukemia patients who eat two     different diets. Patients in the raw group will eat cooked food and the addition of raw     fruits and vegetables. Patients in the cooked group will eat only cooked foods and this is     the standard neutropenic diet with no fresh fruits or vegetables allowed. The primary     objective of the study is to evaluate the infection rate of leukemia patients who eat two     different diets. The secondary objectives will be the incidence of fever requiring     intravenous antibiotics in each group and death rate.   "
236820|NCT00947661|"     A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy     and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar     active ingredient but containing a different preservative as that in Reference0912. Patients     with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to     receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.   "
236821|NCT00947674|"     This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.   "
236822|NCT00947687|"     The objectives of the study are to demonstrate the effectiveness, safety and tolerability of     multiple daily doses of inhaled PUR003, in comparison with placebo, in healthy adults     experimentally inoculated with Influenza A/Wisconsin/67/2005 (H3N2) virus.   "
236823|NCT00947700|"     Early connections has two broad goals:        -  to identify risk indices for autism spectrum disorder (ASD) in 6 to 24 month old infants          who have an older sibling with ASD or infants who have an older neurotypical sibling.        -  to assess whether it is possible to alter risk processes through early intervention with          high-risk infants, thereby reducing social-communication delays or the severity of          autism symptoms.   "
236824|NCT00947713|"     The purpose of this study is to compare the effectiveness of low dose human chorionic     gonadotropin (HCG) in combination with clomiphen citrate to induce ovulation and its     endocrine response in patients who had previously failed to ovulate on clomiphen citrate     alone. The investigators will also compare the effectiveness and endocrine response of this     approach with the regimen of adding HMG to clomiphen citrate.   "
236825|NCT00947726|"     We believe that using a ceramide based foot cream two times a day for two weeks will prevent     water loss and overall foot dryness in patients with non-insulin dependent diabetes.   "
236826|NCT00947739|"     This is a phase I and pharmacology study of Camptothecin-20-O-Propionate Hydrate (CZ48) in     Patients with Solid Tumors or Lymphoma.      OBJECTIVES      Primary:        1. To describe the dose limiting toxicities and adverse event profile of          Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day.        2. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48)          administered orally every day.           Secondary:        3. To perform a pharmacokinetic study of orally administered CZ48 in the plasma.        4. To assess responses by RECIST criteria.        5. To follow patients for survival.   "
236827|NCT00947752|"     The purpose of this study is to compare pain associated with injections and injection-site     reactions of the approved formulation of Glatiramer Acetate (GA) versus investigational     formulation of GA. In addition, the investigators will evaluate the side effects of the two     formulations of GA.   "
236828|NCT00947765|"     Lateral epicondylitis, is a common problem encountered in the orthopaedic practice.     Histopathological reports have shown that lateral epicondylitis is not an inflammatory     process but a degenerative condition termed 'tendinosis'. Beneficial effects of local     corticosteroid infiltration have sound lack of scientific rationale, since surgical specimens     show lack of any inflammatory process. Recently an injection of autologous blood injection     has been reported to be effective for both intermediate and long term outcomes. It is     hypothesized that blood contains platelet derived growth factor induce fibroblastic mitosis     and chemotactic polypeptides such as transforming growth factor cause fibroblasts to migrate     and specialize and have been found to induce healing cascade. The objective of the study is     to evaluate the efficacy of autologous blood injection versus local corticosteroid injection     in the management of lateral epicondylitis.   "
237022|NCT00957762|"     The purpose of this research is to evaluate different methods of measuring body composition     (amount of fat, muscle, bone, and water in your body) and to determine relationships between     body composition and other medical problems associated with spinal cord injury (SCI).   "
236829|NCT00947778|"     The cochlear implant appears today as one of the best technique so as to lead the congenital     deaf children to speak. However the results in terms of accurate access to language remain     partial. These results are usually due to the children own factors (social, educational and     handicap ones), one which any action has a limited effect.      Besides, there are external factors on which one can rely :  treatments . For instance, an     early cochlear implant on a child is the main stream to a better access to speak properly     later. Another essential point to tackle is the early re-education training which remains     essential to the treatment. Yet, there is a gap to fill between the theory and the main     assistance in the auditory education practice.      The main objective of this survey is to evaluate the efficiency of this auditory teaching     programme (MPAA) over the 4 tested skills (identification, discrimination, the analysis of     sounds scenes and its memory) among the pre-speaking cochlear implanted congenital deaf     children aged from 4 to 10.      This study will be divided into two phases separated by 3 sessions of evaluation tests.      The first session T1 will occur in the two groups (experimentation on G1 and control on G2),     then the first training session will start in group G1.      The second session T2 will occur in the two groups, then the first training session will     start in group G2.      The third session T3 will occur in the 2 groups at the end of the experiment.      By training the 4 perceptible operations with different auditory stimulations (speech, music,     sounds and electro-acoustic sounds), we are looking for better performance in the trained     skills as well as a teaching transfer on other linguistic abilities (phonetics discrimination     and speech).   "
236830|NCT00947791|"     The purpose of this study is to determine whether a single intravenous administration of an     N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar     depression.   "
236831|NCT00947804|"     The Simple Acute Coronary Syndrome (SACS) Score was developed as a Risk Stratification Tool     for Acute Coronary Syndrome (ACS). It is a tool which rates a patient's: SYMPTOMS, EKG     FINDINGS, RISK FACTOR PROFILE, and CARDIAC MARKERS on a scale of zero to six.      The purpose of this study is to validate the SACS Scoring tool by establishing a correlation     between the score's numerical values and the degree of obstructive cardiovascular disease     visualized during cardiac catheterization.   "
236832|NCT00947817|"     Prospective study including all the consecutive patients admitted at the Department of     Cardiology, Timone Hospital wih a definite diagnosis of IE according to the modified Duke     criteria. The period of inclusion will be for 24 months. Eighty patients and age-matched     control subject will be included. Primary end point are EE occurring during the antimicrobial     treatment and secondary end points will be 6-month mortality, vegetation length and the     impact of antimicrobial treatment on inflammation-induced procoagulant changes and     endothelial cell activation.   "
236833|NCT00947830|"     The purpose of this study is to find out if the level of imatinib in the bloodstream, and the     level that leukemia cells will predict how quickly your chronic myeloid leukemia improves     with the treatment.      1.1 Primary Objectives      To determine if intracellular levels of Imatinib in leukemic blood cells within two weeks of     treatment initiation of patients with chronic myeloid leukemia in chronic phase predicts     molecular and cytogenetic response at 6 and 12 months post treatment      1.2. Secondary Objectives      1.2.1 To determine if hOCT-1 mRNA levels at diagnosis predict Imatinib intracellular levels     within two weeks of treatment initiation.      1.2.2 To determine the correlation between intracellular Imatinib levels at two weeks of     treatment initiation with plasma Imatinib levels at two and four weeks after treatment     initiation.      1.2.3 To determine if plasma Imatinib levels four weeks after treatment initiation correlate     with plasma Imatinib levels 12 months after treatment initiation.      1.2.4 To determine if intracellular levels of Imatinib in leukemic blood cells within two     weeks of treatment initiation correlate with intracellular levels of Imatinib in normal     leukocytes 12 months after treatment initiation.   "
236834|NCT00947843|"     The purpose of this study is to compare the efficacy and tolerability between clopidogrel     resinate and clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD     equivalents.   "
236835|NCT00947856|"     This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with     brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab     vedotin study.   "
236836|NCT00947869|"     The primary aim of the Erlangen´s Glaucoma Contrast Sensitivity-Study (EGCS-Study) is the     evaluation of the diagnostic and prognostic validity of a diagnostic procedure, measuring     contrast sensitivity. No therapeutic studies are performed.   "
236837|NCT00947882|"     A dose-finding, multi-centre, double-blind, randomised, parallel, placebo-controlled trial to     investigate efficacy and safety of degarelix in men with lower urinary tract symptoms (LUTS)     associated with benign prostatic hyperplasia (BPH)   "
236838|NCT00947895|"     The purpose of this study is to compare intramuscular (IM) ACTH (adrenocorticotropin hormone)     and intravenous (IV) methylprednisolone (Solumedrol) for the treatment of an MS (Multiple     Sclerosis) relapse (exacerbation) after sub-response to an initial 3 day course of IV     methylprednisolone.   "
236839|NCT00947908|"     Dendritic cells (DC) play a key role in the pathogenesis of allergic diseases. The regulation     of blood dendritic cells in patients with hymenoptera venom allergy before and during immune     therapy is unknown.   "
236840|NCT00947921|"     Functional Mitral regurgitation is a now well known entity due to tethering of the valve     either mono-lateral, as happens in lateral myocardial infarction, or bilateral as happens in     dilated cardiomyopathy. Treatment of this pathology, either conserving the valve and     addressing regurgitation by mean of restrictive annuloplasty, or implanting a prosthesis     remains controversial in terms of mid and long term benefit for the patient. The     investigators propose a randomized controlled study to compare the efficacy of both technique     in terms of mortality and freedom from reintervention.   "
236885|NCT00955123|"     Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with     active inflammatory bowel disease (IBD). The investigators have earlier shown that the liver     plays an important role in this stress-catabolism by increasing the production of urea during     the inflammatory process.      The purpose of this study is to examine the effect of the anti-inflammatory drugs     prednisolone and infliximab on the regulation of the urea synthesis in patients with active     ulcerative colitis and Crohn's disease.   "
236841|NCT00947934|"     Alzheimer's Disease (AD) is the most common cause of dementia. Today no treatment had shown     consistent efficacy to stop or slow down the disease. Recent report of enhancement of memory     abilities by bilateral chronic deep brain stimulation (DBS) of the fornix in the hypothalamus     suggests that neuromodulation of circuits involved in memory processes may have therapeutic     implications in AD patients with memory decline.      The primary objectives of this prospective, non-controlled, pilot study are to assess the     feasibility and safety of DBS in AD patients with mild cognitive and memory impairment, and     to evaluate the efficacy of DBS to slow down or stabilize this decline. Five patients with AD     (DSM IV) diagnosed less than two years, with mild cognitive decline (MMSE 20-24), and     specific impairment of episodic memory will be included in a 2-year period. The evaluation     criteria for feasibility will be the proportion of patients undergoing the procedure, chronic     stimulation and evaluation process without adverse event (AE). Efficacy will be evaluated     using numerous cognitive and memory testing including classical instrument used in AD     clinical trials. Changes in behavioral scales, and changes in hypothalamic functions     (clinical, biological and hormonal assessment) will evaluate safety and tolerance. Clinical,     neuro-psychological, biological and imaging assessment will be performed 3 and one month     before and 3, 6, 12 and 24 months after surgery. Bilateral electrodes (Medtronic 3389) will     be implanted, by MR-guided frame-based stereotaxy, in the hypothalamic part of the fornix,     and then connected to the generator (Kinetra, Medtronic). Chronic high-frequency stimulation     will be delivered immediately after surgery.      The investigators expect to slow down, or to stabilize the spontaneous decline of MMSE and     ADAS scores after 6, 12 and 24 months of stimulation. In case of efficacy, DBS might offer to     AD patient the possibility to slow down/stabilize their symptoms, which no other treatment     can currently offer, and to increase their quality of life.   "
236842|NCT00947947|"     The purpose of the current study is to test a computerized HIV/STD prevention program with     heterosexual African Americans. The hypothesis is that those exposed to the program will     increase their correct and consistent use of condoms compared to those not exposed to the     program.   "
236843|NCT00947960|"     The purpose of the study is to determine if triheptanoin is an effective treatment for the     symptoms of Adult Polyglucosan Body Disease.   "
236844|NCT00947973|"     This study will compare the efficacy and cost effectiveness of two methods of treating     adolescents with attention deficit hyperactivity disorder in school.   "
236845|NCT00947986|"     The investigators are looking at the effects of baby shampoo nasal irrigation on the movement     of mucous in the nose in patients who have undergone sinus surgery for chronic sinus     problems.   "
236846|NCT00947999|"     There has been little research on how chronic pain is related to brain activity. The purpose     of this study is to learn more about pain and brain activity by finding any differences in     brain activity among people who have moderate to severe chronic pain and a spinal cord     injury, those who have a spinal cord injury but do not experience chronic pain, and people     who have neither a spinal cord injury nor chronic pain (please note: subjects do not have to     have pain to participate in this study). The information we collect will help the     investigators get a better understanding of chronic pain.   "
236847|NCT00948012|"     Pulmonary hypertension (PH) at rest is a risk factor for death in patients with sickle-cell     anemia (SCA). Exercise echocardiography (EE) can detect latent PH. We sought to investigate     the occurrence of exercise-induced PH in patients with SCA and normal pulmonary pressure (PP)     at rest, and its relationship with clinical and echocardiographic variables.Forty-four     patients with SCA and normal PP at rest were studied and divided into two groups: exhibiting     normal PP after treadmill EE (TRV≤2.7m/s) (G1), and exhibiting exercise-induced PH     (TRV>2.7m/s) (G2). TRV cutoff points at rest and during exercise were based on data from     healthy control subjects, matched for age, sex, and body surface area. Data obtained from EE     were correlated with clinical, echocardiographic and ergometric variables.Exercise-induced PH     occurred in 57% of the sample (G2), significantly higher than those of G1. Exercise-induced     PH was related to higher levels of creatinine (p<0.05), increased left atrial volume (p<0.05)     and right ventricular diastolic area (p<0.05), larger E/Em waves ratio derived from spectral     and tissue Doppler (p<0.05), and higher TRV at rest (p<0.005).We concluded that patients with     SCA and normal PP at rest may exhibit exercise-induced PH, which was related to renal     function, increased cardiac chambers, abnormal indices of diastolic function and baseline TRV     levels.   "
236848|NCT00948025|"     This study is a comparison of sensory recovery outcomes from the use of AVANCE and hollow     tube conduits for peripheral nerve gap repairs in the hand.   "
236849|NCT00948038|"     The objective of this study is to determine the acute effects of a dairy supplement compared     to a soy supplement on oxidative and inflammatory stress in overweight and obese subjects in     the absence of any changes in adiposity.   "
236850|NCT00948051|"     In this study the investigators hypothesized that the chronic intake of     fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus     vaccination and bifidobacteria in infants.   "
236851|NCT00948064|"     The goal of this clinical research study is to learn if the combination of azacitidine and     vorinostat can help to control AML or MDS better than azacitidine alone. The safety of this     drug combination will also be studied.   "
236852|NCT00948077|"     The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of     multiple doses orally administered first-line anti-tuberculosis drugs in subjects with     pulmonary tuberculosis.   "
236853|NCT00948090|"     This is a study for the outcome and safety of individualized busulfan dosing with     cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat     Non-Hodgkin or Hodgkin's Lymphoma.   "
236854|NCT00948103|"     Second line treatment for detrusor hyperreflexia is the intravesical BTX-A injections. First     300 units Botox are diluted with 30 ml of preservative-free saline. Using a rigid cystoscope     and an injection needle, BTX-A is injected into 30 sites within the detrusor muscle.      The used of KALINOX® (50% nitrous oxide and oxygen) inhalation has demonstrated analgesic     efficacy in various procedures (obstetric, liver biopsy, transrectal ultrasound guided     prostate biopsy, emergency) The aim of this study is to investigate the safety and efficacy     of analgesia with N2O/O2 inhalation for detrusor BTX-A injections using a rigid cystoscope.   "
236855|NCT00948116|"     Patients living with diabetes mellitus have double the risk of kidney failure compared to     patients without diabetes following use of dye in many x−rays and procedures to diagnose and     treat narrowing of the arteries (blood vessels) in the heart that can lead to angina or a     heart attack. Heart disease is the commonest cause of death in patients with diabetes. People     with diabetes are more likely to need these tests/treatments. By identifying those at greater     risk of kidney complications we may be able to make these tests/treatments safer and offer     them to more patients with diabetes.   "
237023|NCT00957775|"     The purpose of this study is to develop and evaluate the acceptability and preliminary     efficacy of a web-based, skills training program for adolescents with substance use     disorders.   "
236856|NCT00948129|"     The goal of this study is to learn which of 3 methods is best for helping people quit     smoking.      Objectives:      Specific Aim 1: Specific Aim 1: Compare the efficacy of three smoking cessation interventions     targeting community based low-income uninsured and underinsured individuals in a     group-randomized trial. The interventions will include a Standard Care (SC) approach,     consisting of brief advice to quit smoking, nicotine replace therapy (NRT), and self-help     written materials; an Enhanced Care (EC) approach, consisting of the standard care components     and a cell phone-delivered text/graphical messaging component; and an Intensive Care (IC)     approach, consisting of all SC and EC components plus a series of 11 cell phone-delivered     proactive counseling sessions and a cell phone-delivered text/graphical messaging component.      Hypothesis 1.1. Participants randomized to the EC condition will have higher smoking     abstinence rates at 12-month follow-up compared to participants randomized to the SC     condition.      Hypothesis 1.2. Participants randomized to the IC condition will have higher smoking     abstinence rates at 12-month follow-up compared to participants randomized to the EC     condition.      Specific Aim 2: Evaluate the role of quit motivation, nicotine withdrawal, risk perception,     self-efficacy, social support, and negative affect as potential mediators of smoking     abstinence      Hypothesis 2.1: The EC's and IC's effects on abstinence will be mediated by quit motivation,     nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect.      Specific Aim 3: Compare the cost-effectiveness of the three treatment conditions.      Hypothesis 3.1: Compared to SC and EC, the IC is a cost-effective use of health care     resources.   "
236857|NCT00948142|"     The purpose of this study is to determine the safety and efficacy of CEM-102 compared to     Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).   "
236858|NCT00948155|"     This study will demonstrate the behavioral responses to varenicline, helping to better     understand its mechanisms. Hypotheses for the study are to observe decreases in smoking     topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases     on day 21 relative to day 7 during varenicline treatment. We also propose to examine if     extended duration of treatment has clinical significance in decreasing smoking behaviors,     thus increasing the efficacy of varenicline.   "
236859|NCT00948168|"     The purpose of this study is to determine in type 2 diabetic patients in secondary failure to     combined oral therapy whether, besides improvement in glycemic control, addition of     exenatide, a new drug introduced to treat diabetes before addition of insulin to current     therapy, over 6 months is associated with improvement in beta-cell function, insulin     sensitivity following 24-hours discontinuation of the drug.   "
236860|NCT00948181|"     Stress during surgery leads to significant increase in plasma catecholamine concentrations in     surgeons, anesthesiologists, and patients.   "
236861|NCT00948194|"     In this study, the researchers propose to investigate the efficacy of inhaled nitric oxide to     prevent ischemia-reperfusion (I/R) hepatocyte injury in patients who receive extended donor     criteria(EDC)liver grafts based on changes in proteomic and metabolomic markers following     revascularization of the donor graft.      In reviewing the literature, no uniform extended criteria donor classification exists. The     characteristics most associated with liver graft failure appear to be cold ischemia time     greater than 10 hours, warm ischemia time greater than 40 minutes, donor age > 55 years of     age, donor hospitalization > 5 days, a donation after cardiac death (DCD) graft, and a split     graft. The researchers will exclude warm ischemia time as this is impossible to predict prior     to the transplantation. Any donor meeting at least one of the other criteria will be     classified as an EDC donor.      Hypothesis 1: Inhaled nitric oxide will improve overall outcome of liver recipients after EDC     liver transplantation        -  Suppression of oxidative injury will improve graft function postoperatively as measured          by International Normalized Ratio (INR) bilirubin, transaminases, and duration of          hospital stay.      Hypothesis 2: The mechanisms of therapeutic efficacy of inhaled nitric oxide is based on     reduction in post-reperfusion oxidative injury as readily measured by the detectable changes     in the protein and metabolic profiles in plasma of patients treated with inhaled-NO        -  Nuclear Magnetic Resonance (NMR)-based metabolic markers (xanthine end-products,          lactate, and hepatic osmolytes) that are consistent with acute liver injury will be          decreased in NO-treated recipients.        -  Protein markers of reperfusion injury (argininosuccinate synthase (ASS) and estrogen          sulfotransferase (EST-1) will be greater in the plasma of patients who are not treated          with inhaled-NO        -  Reduced oxidative injury will be reflected by a decrease in the number of mitochondrial          peroxiredoxins isoforms and the number that are oxidized in NO-treated liver recipients.   "
236862|NCT00948207|"     The investigators will test whether narrative life review and web-based social networking for     middle aged adults with advanced cancer will improve:        1. existential well being (and reduce psychological distress)        2. generativity and relationship quality, thereby mediating the intervention effects      The investigators will also conduct exploratory process analyses of each participant's social     network.   "
236863|NCT00948220|"     One single study has suggested that bone mineral density (BMD) is reduced in patients with     non-cirrhotic chronic viral hepatitis C. Antiviral combination therapy with standard     interferon and ribavirin may further decrease BMD. The aim of this study is to systematically     investigate the effect of chronic hepatitis C genotype 1 infection alone and current standard     therapy with peginterferon alfa-2a/ribavirin on BMD and bone metabolism.   "
236864|NCT00948233|"     The goal of this behavioral research study is to test a new multimedia anti-tobacco video     game tailored to the U.S. Army. Researchers want to study how using the program affects     tobacco use in soldiers, as compared to standard anti-tobacco programs.   "
236865|NCT00948246|"     The purpose of this study is to collect additional safety, performance and effectiveness data     of the Easyband gastric band medical device in the treatment of morbid obesity in 4 European     countries where the device is a CE marked approved product.   "
236866|NCT00948259|"     The purpose of this study is to evaluate if 4 escalating doses during 20 weeks of NP031112     are safe and tolerated in patients with Alzheimer´s disease.   "
236867|NCT00948272|"     The purpose of this study is to generate data in human on immunogenicity and safety of     Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.      Primary Objective:        -  To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab,          in terms of seroconversion rate at Day 42 of the primary vaccination series.      Secondary Objectives:        -  To assess the clinical safety of VRVg after each vaccination when administered in a          pre-exposure vaccination schedule with a booster at 12 months after the first          vaccination in all subjects.        -  To describe the immune response induced by VRVg 21 days after two vaccinations in a          subset of randomized subjects and 14 days after the last vaccination of the primary          vaccination series.   "
236868|NCT00948285|"     The purpose of this study is to determine if the use of magnetic resonance imaging (MRI) for     breast cancer translates into better surgical outcomes. MRIs may help ensure that as little     healthy tissue is removed as is possible and may help prevent the need for additional     surgical procedures.   "
236869|NCT00948298|"     Vitamin D is a natural nutrient. A little comes from our normal daily diet. Most of it comes     from our skin after we have been in sunlight. If we have darker skin, we make less vitamin D.     Vitamin D balances the calcium in our body. If our vitamin D levels get too low it can cause     health problems. It may increase our chance of getting high blood pressure or diabetes.     Another problem we may have if our vitamin D levels are low is that our blood vessels may not     work normally. These are important health problems for anyone. Because African Americans have     darker skin, they are more likely than most other racial/ethnic groups to have low vitamin D     levels. This study will look at treating African Americans with low vitamin D levels.      The goal of this study is to see how vitamin D helps blood vessels work. The investigators     will do this study in African Americans who are overweight, have high blood pressure and have     low vitamin D levels. The investigators will see if getting the vitamin D level to a normal     value will improve how blood vessels work. The dose of vitamin D that will be given in this     study is a high dose that is given to people with low vitamin D levels.   "
236870|NCT00954928|"     If operating on the anticoagulated patient has been safe for one of the investigators'     surgeons for the past 10 years then providing prospective data that substantiates this could     prevent complications related to the discontinuation of anticoagulation for hand surgery     patients in the future.   "
236871|NCT00954941|"     The goal of this clinical research study is to compare the effectiveness of receiving a     combination of ondansetron and aprepitant to receiving ondansetron alone in helping to     prevent nausea and/or vomiting in patients with Acute myeloid leukemia (AML) or high-risk     (HR) Myelodysplastic syndromes (MDS) who are receiving cytarabine. The safety of this drug     combination will also be studied.   "
236872|NCT00954954|"     The aim of this prospective study is to compare the clinical and radiographic outcomes of     standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB)     total knee arthroplasty. The investigators hypothesize that total knee arthroplasty performed     with a high-flexion PS RP-MB design would improve range of motion, and that this would be     reflected by a better clinical outcome and greater patient satisfaction.   "
236873|NCT00954967|"     This study addresses an important problem in public health, smoking in diabetics. The     morbidity and mortality observed in diabetics is linked to macro and microvascular problems.     The consumption of tobacco has a multiplying effect on these vascular problems in diabetics.     This study aims to evaluate the effectiveness of an intensive intervention in tobacco     addiction in diabetic patients in primary care.   "
236874|NCT00954980|"     The overall objective will be to evaluate clinical predictors of outcomes in patients who     undergo endovenous sclerotherapy for the treatment of varicose veins.   "
236875|NCT00954993|"     This study will evaluate the hepatic (liver) and plasma pharmacokinetics of Vaniprevir     (MK-7009) by evaluation of ribonucleic acid (RNA) of the hepatitis C virus (HCV) in genotype     1, HCV-infected participants.   "
236876|NCT00955006|"     The purpose of the study is to determine the safety of mucosal immune responses to a DNA HIV     vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.   "
236877|NCT00955019|"     This study is being done to see how biomarkers (abnormalities in molecules of cells ) present     in their Barrett's esophagus agree with results from surveillance biopsies; and to compare     three different brush devices used to collect cells to see which of these 3 brush devices     obtains a higher number of cells.   "
236878|NCT00955032|"     The purpose of this research study is to attempt to treat apathy in Parkinson's disease (PD)     using high-frequency repetitive transcranial magnetic stimulation (rTMS) of the brain and to     investigate the patterns of brain activation that may be involved in apathy. It is     hypothesized that high-frequency rTMS of the left mid-dorsolateral frontal cortex will     improve apathy in PD.   "
236879|NCT00955045|"     The primary objective of this study was to establish the long-term tolerability and safety of     istradefylline treatment in subjects with Parkinson's disease treated with     levodopa/carbidopa. In addition, treatment response and maintenance of response were     assessed.   "
236880|NCT00955058|"     The purpose of this study is to evaluate the effect of oral contraceptive on the serum free     prostatic specific antigen (PSA)in women with polycystic ovary syndrome(PCOD)compared with     cyproterone compound.   "
236881|NCT00955071|"     The investigators will randomize abdominally obese men and women at increased health risk to     one of the following 4 conditions: 1) No-exercise, wait list controls (C), 2) Low volume, low     intensity exercise (LVLI), 3) High volume, low intensity exercise (HVLI), 4) Low volume, high     intensity exercise (LVHI).      The primary aim of the trial is to determine the effects of varying exercise dose (energy     expenditure, kcal) or intensity (relative to VO2max (cardiorespiratory fitness)) on waist     circumference and glucose tolerance. The investigators will test the following hypotheses: 1)     That the reduction in waist circumference and improvement in glucose tolerance in response to     all treatments will be greater than controls. 2) That reduction in waist circumference and     improvement in glucose tolerance in HVLI and LVHI will be greater than LVLI. 3) That     hypotheses 1 and 2 are true independent of gender.   "
236882|NCT00955084|"     The primary objective of this study is to allow rollover of the two remaining subjects from     the other XL999 studies to continue to receive XL999.      The secondary objectives of this study are as follows:        -  To evaluate tumor response after long term repeat administration of XL999 in two          subjects rolled over from other XL999 studies.        -  To characterize the long term safety and tolerability of XL999 after repeat          administration in two subjects rolled over from other XL999 studies.        -  To characterize the long term effects of XL999 on cardiac function after repeat          administration in two subjects rolled over from other XL999 studies.   "
236883|NCT00955097|"     The primary purpose of this study is to demonstrate the safety and effectiveness of using an     intra-operative ultrasound contrast agent(Definity®) for the identification of known liver     tumors.   "
236884|NCT00955110|"     The purpose of this study is to compare the subjective and objective effects of Oxymorphone     ER (Opana ER) versus Oxycodone CR (Oxycontin).   "
236886|NCT00955136|"     The study will see if mechanical impulses delivered by an echocardiographic probe during a     continuous infusion of MRX 801 are capable of improving blood flow in smaller heart vessels     in patients with acute coronary syndromes.   "
236887|NCT00955149|"     Primary sclerosing cholangitis (PSC) is a chronic inflammatory condition of the bile ducts of     unknown etiology. It is characterized by diffuse inflammation and stricturing of the entire     biliary tree, eventually resulting in cirrhosis of the liver. Patients with PSC are at     increased risk for the development of cholangiocarcinoma (CCA), a cancer arising from bile     duct epithelium. This risk is estimated to be approximately 1 to 1.5% per year. It is     postulated that chronic inflammatory changes in the biliary epithelium promote CCA formation.     The prognosis of CCA is fatal. The only potentially curative therapy is surgical; however,     only a minority of patients qualify for surgical treatment.      Several studies have demonstrated overexpression of the epidermal growth factor receptor     (EGFR) in CCA cells. EGFR is a type 1 tyrosine kinase promoting cell proliferation, migration     and altered cell adhesion - typical characteristics of malignant neoplasias. In CCA cells,     EGFR-activation is sustained resulting in cancer progression. In human CCA samples,     EGFR-expression correlates with higher histologic grade, poor prognosis, and risk of     recurrence. The EGFR gene is located on the short arm of chromosome 7 (7p12). Chromosomal     abnormalities of the bile duct epithelium, particularly trisomy 7 (i.e. three copies of     chromosome 7) can be detected in biliary epithelial samples obtained by endoscopic retrograde     cholangiopancreatography (ERCP) in PSC patients. The finding of cells with trisomy 7 has     preceded the development of aneuploidy and multiple chromosomal abnormalities in a number of     patients, the latter chromosomal abnormalities are characteristic of CCA. Trisomy 7 amplifies     the gene for EGFR thereby presumably promoting overexpression of this growth factor receptor.     In a cohort of patients with Trisomy 7 and Primary Sclerosing Cholangitis patients followed     for 1 year, the rate of development of Cholangiocarcinoma was 35% (n=37, Dr. Gores,     unpublished observation). Patients without cytologic abnormalities were at minimal risk for     the development of CCA.      Erlotinib (Tarceva) is a human EGFR type 1 tyrosine kinase inhibitor. Tarceva received FDA     approval as single agent treatment for patients with locally advanced or metastatic non-small     cell lung cancer. In a randomized, double blind, placebo controlled trial of 731 patients,     receiving 150 mg of Tarceva or placebo once daily, median survival was prolonged to 6.7     months from 4.7 months (p<0.001). Analysis of epidermal growth factor receptor expression     (45% of total study patients) demonstrated greater survival benefit in EGFR positive     patients. Tarceva in combination with Gemcitabine is also FDA approved as first line therapy     in patients with locally advanced, unresectable or metastatic pancreatic cancer.      Our central hypothesis is that patients with trisomy 7 will have carcinogenic changes     including EGFR overexpression. EGFR blockade will inhibit a growth/survival advantage for     these premalignant clones eliminating them from the biliary epithelium. As an initial step     towards testing this hypothesis, the tolerability of Tarceva in this patient population needs     to be established. This study will assist in determining the safety and tolerability of     Tarceva in patients with primary sclerosing cholangitis. This study will be followed by a     Phase 2 randomized controlled trial of Tarceva in patients with Primary Sclerosing     Cholangitis with Trisomy 7.   "
236888|NCT00955162|"     Patients who admit to using buprenorphine by the intravenous route will be randomized to     either Subutex or Suboxone and be followed up for 3 months to determine if there is less     injection with Suboxone than with Subutex based primarily on patient diaries.      Patients randomized to Suboxone may continue to receive the product for a further 9 months at     their request and will be monitored at 3 month intervals.      Patients will receive a payment for the inconvenience of keeping a daily diary and to cover     their travel expenses.   "
236889|NCT00955175|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor over a shorter period of time may kill more tumor cells and cause less damage to     normal tissue.      PURPOSE: This phase II trial is studying the side effects of hypofractionated 3-dimensional     radiation therapy and to see how well it works in treating patients with newly diagnosed     stage I, stage II, or stage III non-small cell lung cancer.   "
236890|NCT00955188|"     RATIONALE: A computer program that provides information on colorectal cancer screening based     on a patient's test preferences may be more effective than a computer program that gives     standard information in helping patients get regular colorectal cancer screenings.      PURPOSE: This randomized clinical trial is studying computer-based tailored information to     see how well it works compared with standard information for colorectal cancer screening.   "
236891|NCT00955201|"     This study will determine the type and combination of exercise needed to rehabilitate the     neuro-compromised diabetic Veteran. Guided exercise protocols may prove to be practical     therapeutic options for the prophylactic management of diabetic subjects with neuropathy.   "
236892|NCT00955214|"     The utilization of paclitaxel-eluting coronary stents in small vessel diseases is effective     in reducing both repeat revascularization and major adverse cardiac events within two year     follow-up. To evaluate the procedural, short and long term clinical outcomes of the Taxus     Liberte™ Paclitaxel-Eluting Coronary Stent in small coronary arteries of ≤ 2.5 mm in the     reference vessel diameter.   "
236893|NCT00955227|"     The objective of this study is to determine if the administration of a cholesterol lowering     drug like ezetimibe will reduce circulating omega-3 fatty acid (ALA) levels in patients with     heart disease and hypercholesterolemia.      The investigators hypothesize that their data will discover that patients receiving ezetimibe     require additional dietary supplementation with omega-3 supplements to insure that these     beneficial fatty acids are available to these patients.   "
236894|NCT00955240|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Giving radiation therapy together with combination     chemotherapy and cetuximab may kill more tumor cells.      PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin,     fluorouracil, and cetuximab to see how well it works in treating patients with locally     advanced anal cancer.   "
236895|NCT00955253|"     To find out if spatial neglect following stroke and brain injury can be reduced using     guanfacine, a drug that was shown to improve neglect in two stroke patients in a previous     pilot study (Malhotra et al, 2006). In this trial, the effects of guanfacine will be examined     in a larger number of patients, and there will also be a systematic assessment of whether the     drug is only effective in patients with particular patterns of brain damage.   "
236896|NCT00956059|"     The aim of this clinical trial is to determine the effect and security of low-dose Prednisone     Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis.   "
236897|NCT00956072|"     RATIONALE: Surgery may remove residual disease in patients with gastrointestinal stromal     tumor that is responding to imatinib mesylate. It is not yet known whether surgery is more     effective than continued imatinib mesylate in treating patients with metastatic     gastrointestinal stromal tumor.      PURPOSE: This randomized phase III trial is studying giving imatinib mesylate therapy     together with surgery to see how well it works compared with imatinib mesylate alone in     treating patients with metastatic gastrointestinal stromal tumor that is responding to     imatinib mesylate.   "
236898|NCT00956085|"     Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3%     of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as     obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only     medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with     SRI treatment, most patients continue to experience significant OCD symptoms, impaired     functioning, and diminished quality of life. Recent evidence suggest that a different     neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target     glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from     OCD. In this study the investigators are recruiting patients to receive the drug memantine,     which is thought to modulate the neurotransmitter glutamate, added to whatever other OCD     medications they are taking.      Open label memantine will be titrated in 5mg increments weekly to target dose of 10mg po bid     for up to 6 weeks. Memantine will be continued to 12 weeks in those with treatment     response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV     ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks     of memantine).   "
236899|NCT00956098|"     This study investigated the effectiveness and safety of oltipraz therapy in treating patients     with cirrhosis induced by chronic hepatitis type B or C.   "
236900|NCT00956111|"     A single center, stratified, randomized and double-blind phase IV clinical trial is to be     conducted in healthy elders (equal to or more than 61 years), adults (18-60 years),     adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity     of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.   "
236901|NCT00956124|"     The aim of this study is to determine whether fundus autofluorescence and macular pigment     distribution in inflammatory and diabetic macular edema are altered.   "
236929|NCT00956488|"     The purpose of this study is to find out if supervised exercise training using a treadmill     with partial weight support is safe and has an impact on gait and function of persons with     Amyotrophic lateral sclerosis.   "
236902|NCT00956137|"     Spinal anesthesia is the technique of choice in patients undergoing total joint arthroplasty     at Toronto Western Hospital (UHN). The most significant predictor of the ease of performance     of spinal anesthesia is the quality of palpable surface landmarks (the spinous processes of     the lumbar vertebrae). These surface landmarks may be absent, indistinct or distorted in many     of the patients presenting for total joint arthroplasty. This is because of obesity, previous     spinal surgery, scoliosis and degenerative changes of aging. The investigators have shown in     a previous study that a pre-procedural ultrasound scan of the spine can reliably identify an     appropriate site for needle insertion in spinal anesthesia, and that this results in a high     success rate on the first needle insertion attempt (84% vs 61-64% in published studies). The     investigators therefore believe that this ultrasound-assisted technique of spinal anesthesia     is extremely useful, especially in patients with poor-quality surface landmarks. However     there are no published randomized controlled trials to date that compare the efficacy of the     ultrasound-assisted technique with the traditional surface landmark-guided technique of     spinal anesthesia.   "
236903|NCT00956150|"     The adverse impact of Gulf War Syndrome (GWS) on the health of veterans and on the resources     of the VA Healthcare System underscores the need to resolve its underlying cause. In     response, the investigators propose to investigate the central hypothesis that gut bacteria     may be responsible for symptoms associated with GWS. The investigators will enroll a total of     120 patients with GWS and 90 healthy controls.   "
236904|NCT00956163|"     This phase 0 trial studies whole body fluorine F 18 sodium fluoride positron emission     tomography (PET)/computed tomography (CT) scan and whole body magnetic resonance imaging     (MRI) in finding bone metastases in patients with prostate cancer. Diagnostic procedures,     such as whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI, may help     find and diagnose bone metastases.   "
236905|NCT00956176|"     The goal of this clinical research study is to learn how the body absorbs and processes 1     dose of cidofovir that is given directly into the bladder, in patients with a viral infection     that is causing bleeding from the bladder.      The safety of this drug dose and the investigational way it is given (directly into the     bladder) will also be studied.   "
236906|NCT00956189|"     The investigators developed an easy identification model to identify metabolic syndrome in     patients with schizophrenia or schizoaffective disorder who received treatment of clozapine,     olanzapine, or risperidone. The accuracy of the investigators' models showed well. In the     study, the investigators aim to (1) to examine whether the developed identification models     can be generalized to patients taking other antipsychotics or patients with other diagnoses;     (2) to develop an easy risk score and validate it; (3) to switch antipsychotics to     amisulpride or aripiprazole for those with metabolic syndrome, and compare the changes of     metabolic parameters including adiponectin, and analyze their association with genetic     variants, demography, and clinical variables; (4) to establish models using artificial neural     network and statistic method to predict metabolic response after a switch to amisulpride or     aripiprazole; (5) to investigate the effect of antipsychotics on adiponectin gene expression     and secretion during the differentiation process of 3T3L1 adipocytes.   "
236907|NCT00956202|"     The purpose of this study is to generate data on immunogenicity and safety of the monovalent     H1N1 vaccine in support of the development and registration.      Primary objectives:        -  To describe the immune response to vaccines 21 days after each vaccination in all          participants.        -  To describe the antibody persistence eight months after the first vaccine administration          using HAI method, in a subset of participants who received two injections.        -  To describe the immune response against the A/H1N1 strain using HAI method 21 days after          a vaccination with the 2010-2011 NH seasonal TIV administered approximately 13 months          after the first vaccination in the subset of participants who received two injections.        -  To describe the safety profile of each vaccine in all participants.   "
236908|NCT00956215|"     The study drug, Aprepitant, is currently used to control chemotherapy induced nausea and     vomiting and is also approved for post-operative nausea and vomiting. The investigators'     evaluation of it in morbidly obese patients will demonstrate its ability to control nausea     and vomiting post-operatively in this subset of patients.   "
236909|NCT00956228|"     The current study involves a novel and aggressive therapeutic approach for patients' prostate     cancer. In addition, the investigators propose to administer hormonal therapy to patients     with an especially high risk: those with initial Gleason scores of > 6, PSA > 10 ng/ml, T3/T4     primary tumors, and those found to be node positive (N+). The use of hormonal therapy in     these specific settings correlates with our current standard of care. IMRT is better able to     spare and protect normal tissues from receiving radiation than 3-D conformal RT. The     radiotherapy would be followed by continued hormonal therapy for a total of 6 months in those     who have one of the following Gleason 7 and PSA 10-20 and as per the previous version of this     trial, 1 year similar to that delivered by the EORTC for higher risk patients, (those with     initial Gleason scores of > 8, PSA > 20 ng/ml, or T3/T4 tumors). Those found to be N(+) would     have the hormonal therapy continued indefinitely or until disease progression occurred in a     manner analogous to the Messing et. al. series in prostatectomy patients. The goals are to     develop and administer a program of treatment that includes the most recent developments in     imaging, integrating data from both the CT scan and the ProstaScint scan to optimize prostate     cancer RT. The CT scan will be used for staging and to determine the exact location of the     entire prostate which will receive a reasonable dose of RT. The ProstaScint will be used to     assess the spread of disease to lymph nodes as well as to determine the exact location of the     tumor within the prostate gland. This region will then be boosted to a tumorcidal dose. The     investigators then plan to monitor the toxicity and outcome of this treatment. The     investigators expect that this program of radioimmunoguided IMRT will likely result in     similar or less toxicity and increased cure rates when compared to conventional radiotherapy     and standard IMRT programs.   "
236910|NCT00956241|"     The objective of this study was to compare the functional and surgical results of the J-pouch     with those of the side-to-end anastomosis and their impact on quality of life.   "
236911|NCT00956254|"     This was an open-label, single-dose study to assess the safety, tolerability, and     absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in     opioid-tolerant cancer subjects, with or without oral mucositis.   "
236912|NCT00956267|"     The purpose of this study is to compare and determine the efficacy of letrozole     administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with     Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.   "
236913|NCT00956280|"     The purpose of this study is to characterize the demographic and clinical aspects, and     describe the frequency and type of KRAS mutation in a Brazilian population sample with     advanced non-small cell lung cancer (NSCLC).   "
239788|NCT00998036|"     This is a Phase I research study designed to determine the maximum tolerated doses of     cisplatin, temsirolimus, and erlotinib in combination for treatment in triple negative breast     cancer (TNBC) patients.   "
236914|NCT00956293|"     This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks     after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well     tolerated as standard treatment but optimizing immunosuppressive therapy with benefits in     renal function, new-onset diabetes mellitus, cardiovascular risk, cancer and allograft     nephropathy.   "
236915|NCT00956306|"     This study is designed to assess the effect of hepatic impairment on the pharmacokinetics,     safety and tolerability of udenafil in subjects with hepatic impairment compared to healthy     subjects.   "
236916|NCT00956319|"     The purpose of the study is to investigate the efficacy and safety of zolpidem modified     release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary     insomnia.   "
236917|NCT00956332|"     The purpose of this study is to evaluate the safety and activity of two doses of     MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential     treatment for patients with chronic critical limb ischemia.   "
236918|NCT00956345|"     This trial is conducted in Europe, Japan and the United States of America (USA).      The aim of this clinical trial is to investigate the safety and pharmacokinetics (the     determination of the concentration of the administered medication in blood over time) of     Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with     Haemophilia B.   "
236919|NCT00956358|"     Haemopoietic stem cell transplantation (HSCT) has become a major life-saving treatment for     many haematological conditions, mostly malignancies.      However, there are lots of potential complications that hinder the long-term success of HSCT,     in which bronchiolitis obliterans syndrome (BOS) is one of such serious complications.     Basically, BOS represents a form of graft-versus-host immunological damage of small airways     (bronchioles), leading to progressive narrowing of small airways and thus obstructive lung     function abnormalities. With progressive loss of lung function in BOS, patients after HSCT     can be complicated by intractable respiratory failure that results in mortality. Up until     now, there is still no reliable way to accurately predict or detect BOS early to allow     pharmacological interventions.      Therefore there is intense interest in the search for biomarkers that can help to predict the     occurrence of BOS after HSCT. Apart from biomarkers (e.g., cytokines) in blood, there has     been recent development in the sampling of airway lining fluid by a non-invasive method,     i.e., collection of exhaled breath condensate (EBC). In airway diseases such as asthma or     chronic obstructive pulmonary disease, EBC has been found to have various cytokines which can     serve as potential biomarkers of disease activity. Since BOS is largely a small airway     disease, it becomes logical to investigate the profile of biomarkers in EBC as predictors for     BOS after HSCT.      Therefore this study has been designed to look into the role of biomarkers in blood and EBC     in early detection of BOS after HSCT.   "
236920|NCT00956371|"     The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in     healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and     pharmacodynamic profiles of ONO-7746.   "
236921|NCT00956384|"     Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast     reconstructive option for breast cancer patients selected for immediate, skin-sparing     mastectomy. This procedure has been demonstrated to be oncologically safe in patients with     specific criteria for early stage breast cancer. The primary drawback, however, is that it     requires two separate procedures under general anesthesia and multiple office visits for     expander inflation to create the breast mound. Acellular dermal matrix has gained widespread     acceptance for use in breast reconstruction and other areas and has the potential to provide     support to the breast implant without tissue expansion in a one-stage procedure. The purpose     of the study is to test this new procedure and to evaluate the impact of one-stage breast     reconstruction using acellular dermis compared to the standard two-stage expander/implant     technique on measures of patient satisfaction and quality of life.   "
236922|NCT00956397|"     The prevalence of functional dyspepsia (FD) is estimated to be 15% of the adult population.     FD is commonly described as a condition of chronic abdominal discomfort localized to the     upper abdomen. Postprandial bloating, pain, nausea, vomiting, belching, and early satiety are     common symptoms of the FD patient. FD is defined by >12 weeks of symptoms, which need not be     consecutive, within the preceding year consisting of a) persistent or recurrent dyspepsia and     b) an absence of organic disease after a gastrointestinal endoscopy or x-ray series. FD is     therefore considered a disorder of function because no mucosal pathology is seen in these     patients, as in patients with other functional disorders such as irritable bowel syndrome     (IBS) and fibromyalgia (FM). There is a remarkable degree of overlap among these three     disorders. These 3 disorders share the finding of hypersensitivity and the symptom of     postprandial bloating to suggest the possibility of a common origin.   "
236923|NCT00956410|"     This study will evaluate the safety and tolerability of repeated subcutaneous injections of     CAD106 in patients with Alzheimer's disease.   "
236924|NCT00956423|"     The purpose of this study is to compare the efficacy of two different physical activity     regimens as complementary or alternative treatment options for the treatment of obstructive     sleep apnea. A secondary purpose of the study is to examine the effects of these activity     regimens on various health consequences of obstructive sleep apnea, including blood pressure,     systemic inflammation, and daytime functioning.   "
236925|NCT00956436|"     This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced     hepatocellular carcinoma.   "
236926|NCT00956449|"     The purpose of this study is to evaluate the antibody response to each of the three influenza     vaccine strains included in the licensed seasonal flu vaccine, as measured by     hemagglutination inhibition (HI) at 21 days post immunization in non−elderly and elderly     subjects in compliance with the requirements of the current European Union (EU)     recommendations for the evaluation of the immunogenicity for a new formulation of a licensed     flu vaccine (CPMP/BWP/214/96).   "
236927|NCT00956462|"     This study aims to evaluate the eye pressure response to non-steroidal anti-inflammatory eye     drops as compared to steroid eye drops following glaucoma surgery.   "
236928|NCT00956475|"     RATIONALE: Collecting information about the effect of hematologic cancer and its treatment on     quality of life may help doctors learn more about the disease and plan the best treatment.      PURPOSE: This phase I trial is studying quality of life in younger leukemia and lymphoma     survivors.   "
236931|NCT00956514|"     Transcranial magnetic stimulation (TMS) therapy has proven to lead to symptom improvement in     many individuals with major depressive disorder (MDD), yet there is heterogeneity in outcome,     with some patients showing robust remission and other showing minimal symptom change.     Identifying which individuals are likely to benefit from TMS therapy early in the course of     treatment would support continued treatment for those predicted to do well, and consideration     of alternative treatments for others individuals. This study will test specific hypotheses     about the relationships between early neurophysiologic changes and later clinical outcome     with TMS treatment.   "
236932|NCT00956527|"     This is a Stage 1A/1B behavioral therapy development project with the aim of developing and     piloting an early intervention based upon traditional martial arts for adolescents who are in     the early stages of substance use/misuse.      The primary aims of this study are:      1) To develop a manualized version of an existing, typical traditional martial arts program,     modified to target a reduction in substance use and the associated behavioral and     psychosocial problems for adolescents in the early stages of substance use or misuse, based     on principles derived from empirically-based prevention programs. 2) To obtain preliminary     pilot data on recruitment feasibility, validity of assessments, and estimates of the effect     size of the intervention in reducing substance use and improving prosocial behavioral and     psychosocial outcomes. 3) To refine and further develop the manualized program based on pilot     data and utilizing feedback from the initial cohort of participants, traditional martial arts     program instructors and substance abuse treatment experts. The goals of these revisions would     be to maximize the impact of the program on substance use and behavioral outcomes, while     retaining the core features of a traditional martial arts program to ensure the feasibility     of implementing, sustaining, and disseminating such a program in existing community-based     martial arts programs. 4) To develop procedures for training interventionists (i.e., martial     arts instructors and research assistants) and for monitoring program adherence to ensure     fidelity. 5) To conduct a small pilot study of the refined manualized program to enable us to     estimate the effect size of the intervention and provide information for estimating power for     a larger randomized controlled trial should the results of this intervention prove promising     in terms of positive impact on the primary and secondary outcome measures: decreased drug use     and improvement in psychosocial functioning and behavioral problems (including aggression).   "
236933|NCT00956540|"     The purpose of this study is to determine whether deflating the tracheal cuff in     tracheostomized patients, during disconnections from ventilatory support along the weaning     phase shortens the weaning time.   "
236934|NCT00956553|"     This is a phase IV study to evaluate the body's immune response of participants to the     Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with     increased risk of cervical cancer.   "
236935|NCT00956566|"     The investigators will test the hypothesis that a LOW CARB hypocaloric diet will reduce body     weight over six months more than a LOW FAT hypocaloric diet. In addition to body weight, the     investigators will measure cardiovascular and metabolic variables and will take blood samples     in order to determine whether certain metabolites may predict the diet success.   "
236936|NCT00956579|"     Among the most commonly reported symptoms of autism is heightened sensitivity to sensory     stimuli. Children and adults with autism spectrum disorders often react with aversion to     various sounds (e.g., by covering their ears and screaming) especially at an early age. The     investigators believe that this is because autism spectrum disorders affect how sensory input     is experienced. Therefore, the purpose of this study is to investigate sensory processing     abnormalities in autism spectrum disorders, or, in other words, to evaluate how and why     children and adults with autism spectrum disorders experience external sensory information     (vision, audition, touch) differently than healthy children and adults.      Because some of the same abnormalities are also reported in children and adults with     developmental language disorders such as language delay or dyslexia, the investigators are     also interested in how that population experiences external sensory information.   "
236937|NCT00956592|"     This study aims to evaluate the utility of a video assisted device for intubation (placement     of a breathing tube) during surgery. This study specifically aims to compare a video assisted     intubation with the CMAC laryngoscope to conventional devices in the setting of intubations     predicted to be difficult.   "
236938|NCT00956605|"     This study examines the efficacy of two computer-based training systems to teach children     with ADHD to attend more effectively.   "
236939|NCT00956631|"     This is a multi-center, prospective, clinical study to assess the clinical application and     outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal     stenosis.   "
236940|NCT00956644|"     Primary Objective:        -  To demonstrate that the antihypertensive efficacy of the fixed combination          irbesartan/amlodipine 150/5 mg is superior to that of amlodipine 5 mg monotherapy in          lowering systolic blood pressure (SBP) as measured by home blood pressure measurement          (HBPM) after 5 weeks of treatment (W5)      Secondary Objective:        -  To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine          150/5 mg with that of amlodipine 5 mg monotherapy after 5 weeks of treatment (W5)        -  To compare the antihypertensive efficacy of the fixed combination therapy          irbesartan/amlodipine 150/10 mg with that of amlodipine 10 mg monotherapy at the end of          treatment (W10)        -  To examine in each treatment group the change from week 5 to week 10 in SBP and          diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement          (OBPM)        -  To determine the incidence and severity of adverse events   "
236941|NCT00956657|"     Cardiac rehabilitation (CR) programmes typically offer patients with heart disease a     long-term programme of medical evaluation, exercise, education and counseling. National     guidelines have recognized the positive impact that attendance at CR can have following heart     attacks, angina and other heart problems. Patients who attend such a programme have been     shown to have reduced health problems. Despite this, research suggests that the use of these     services is poor and that the majority of patients eligible for these programmes do not     continue to attend after their first class. A range of factors have been associated with     non-adherence to CR, including psychological factors such as people's beliefs about their     illness. For example, patients with high levels of perceived control over their illness after     a heart attack appear to be more likely to attend CR classes than those with low levels of     perceived control. Such findings suggest that changing patients' illness beliefs,     specifically those associated with illness control and illness consequences, could help to     increase adherence to CR programmes. Increased adherence to CR could improve health outcomes     for patients with cardiac illnesses. The present study is therefore investigating the     effectiveness of a one-session psychological intervention, based on a theory called the     Self-Regulatory Model, in altering beliefs about illness among patients starting cardiac     rehabilitation. Participants will be randomly assigned to a treatment or a non-treatment     group. It is hoped that those who receive the treatment session will attend more CR classes.   "
236942|NCT00956670|"     This clinical trial studies lymphedema after surgery in patients with endometrial cancer,     cervical cancer, or vulvar cancer. Collecting information over time about how often     lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer,     cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan the     best treatment.   "
236943|NCT00956683|"     Current best practice for performance of infraclavicular block dictates the use of a     dual-endpoint nerve stimulation technique that still only results in a 79% success rate. Use     of an ultrasound-guided technique has the potential to significantly improve success. A     randomized, controlled study to evaluate this area remains to be performed and is required to     demonstrate to anesthesiologists that an ultrasound-guided approach should supersede nerve     stimulation as the technique of choice for infraclavicular block.   "
236944|NCT00956696|"     It has been estimated that 22 - 32% of people with mental retardation or learning disability     have co-existing epilepsy. Despite such high prevalence and although there may be particular     concerns over the effects of treatment on behaviour and cognition in this population, few     studies have specifically addressed these concerns. Topiramate (TPM) is one of the modern     antiepileptic drugs that has been approved for the treatment of a broad range of seizure     types in both children and adults. There is evidence of associated improvement in behaviour     with treatment but data is conflicting. The investigators aim to further study the effect of     TPM on seizure control and behaviour using the Scales of Independent Behavior-Revised (SIB-R)     which has been applied in similar patient populations and is widely adopted locally to assess     the behaviour of people with mental retardation. This is a naturalistic, open label, single     arm prospective study of 16-week in duration. Eligible adult patients will be initiated on     TPM. Patients will be evaluated at baseline, end of weeks 4, 10 and 16. At each visit seizure     control and any adverse events will be assessed. Behaviour will be assessed using SIB-R     (Chinese version) at baseline and each study visit. At the end of the study period the     patient's overall improvement will be rated by the investigator and the caregiver using     global evaluation scales. Patients with improvement will be maintained on TPM after the end     of the study period Titration schedule Topiramate will be administered orally as per usual     clinical practice. Treatment will be initiated at 25 mg daily for 1 week, and increased in     25- to 50-mg increments at one- to two-weekly intervals, to an initial target dose of 100 -     200 mg daily in 2 divided doses according to each individual's response. Further dose     adjustment can be made in response to further seizures or emergence of adverse events..   "
236945|NCT00956709|"     Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major     surgery of the foot. The literature does not highlight a significant difference in terms of     onset of action between these two molecules to block the sciatic nerve [4]. Our hypothesis is     that this lack of difference is due to the use of a neurostimulator for locating the     injection site (indiscriminate nature of the anatomical approach to the sciatic nerve).     Indeed, the sensitivity of neurostimulation is low compared with ultrasound [58] and     ultrasound, for accurate visualization of the deposit of the local anesthetic around the     nerve to improve the quality of the block and reduce the onset of action of local anesthetic     [46, 47].      The investigators propose to make a comparative trial between levobupivacaïne 0.5%     ropivacaine and 0.5% under the control of the ultrasound as part of a sciatic nerve block.     The use of ultrasound will reduce the variability of results because the changes would be     linked exclusively to the local anesthetic. The investigators test the hypothesis that     levobupivacaïne gives better results in terms of onset of action than ropivacaine.   "
236946|NCT00956722|"     This is an exploratory trial of Bovine Colostrum powder to decrease translocation of     gut-derived microbial products and immune activation in HCV infection.      The study is designed as a single-arm, open-label, before-and after exploratory trial of 10     weeks of Bovine Colostrum Powder (BCP) to reduce translocation of intestinal microbial     products and immune activation in patients suffering from chronic hepatitis C virus (HCV)     infection.      The study population will include HCV-infected (genotype 1) men and women, ≥ 18 years of age,     not receiving anti-viral therapy at the time of enrollment and for at least the previous 3     months. Having failed previous anti-viral therapy (non responders), HCV recurrence after 72     weeks of therapy, developed side effects which mandated stopping anti viral therapy, or not     considered eligible for initiation of such treatment, with a plasma HCV RNA level ≥ 1000 I.U.   "
236947|NCT00956735|"     This study is investigating the effects of three different diets, including a diet with     pistachios, on cardiovascular disease risk markers in people with type 2 diabetes.   "
236948|NCT00956748|"     Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of     patients do not respond to routine antibiotic or surgical treatments. The current treatment     involves administering combination antibiotic anti-inflammatory ear drops such as Ciprodex     (ciprofloxacin 0.3% / dexamethasone 0.1%). Although most patients experience a relief of     symptoms, a fraction of patients remain refractory to treatment. Recent findings suggest that     the addition of N-acetylcysteine (0.5-2%) to Ciprodex is a superior treatment for otitis     media with effusion compared to the use of Ciprodex alone.   "
236949|NCT00956761|"     This is a trial for annual registration of the updated seasonal influenza vaccine     formulation.   "
236950|NCT00956774|"     The aim of this study is to compare the three commonly used hysterosalpingography (HSG)     injection devices on the basis of patient pain perception, total fluoroscopic and procedural     time, and side effects in a prospective, randomized study. An important and novel secondary     outcome is the comparison of the quality of images obtained with these three devices. The     investigators hypothesize that the balloon catheter and cervical vacuum cup will be less     painful than the acorn tipped cannula and that there will be no difference in image quality     between the three groups.   "
236951|NCT00956787|"     The purpose of this study is to determine if AR-67 is effective in the treatment for patients     with MDS.   "
236952|NCT00956800|"     The purpose of this study is to determine if providing some care to diabetic patients     remotely, using Accuchek 360 yields at least the same clinical results for their diabetes     care, according to existing guidelines, as providing all care to patients in person.   "
236953|NCT00956813|"     RATIONALE: Estrogen can relieve the symptoms of menopause, but can also cause the growth of     breast cancer cells. Flaxseed may reduce the number of hot flashes and improve mood and     quality of life in postmenopausal women not receiving estrogen therapy.      PURPOSE: This randomized phase III trial is studying flaxseed to see how well it works in     treating postmenopausal women with hot flashes who have a history of breast cancer or other     cancer or who do not wish to take estrogen therapy.   "
236954|NCT00956826|"     The investigators have added an additional electrode to the vacuum device for birth in which     they can monitor the fetus during delivery.   "
236955|NCT00956839|"     The purpose of this study is to determine the efficacy of 2 different doses of intramuscular     (IM) vitamin D3 as compared to an oral replacement dose in normalizing vitamin D levels in     the blood of patients with tropical calcific pancreatitis.   "
236956|NCT00956852|"     Lung cancer has remained as the top cancer killer in Hong Kong. Even for early resectable     stage of lung cancer, only around 60-70% of patients can survive for 5 years after operation,     mostly related to disease recurrence. Therefore there is urgent need for predictive     biomarkers that can potentially help in monitoring patients for risk of disease recurrence     after operation. Recent studies have suggested an important role of oxidative stress in the     development of lung cancer and our preliminary data have suggested that some of the oxidative     stress markers in blood could be predictive of response to systemic chemotherapy for lung     cancer. Apart from potential biomarkers from blood, ongoing study has also been conducted to     investigate the predictive role of biomarkers in exhaled breath condensate in lung cancer     patients undergoing chemotherapy. Exhaled breath condensate can be collected simply with a     disposable commercially available device that allows trapping of breath condensate via a     cooling column during normal breathing for 20 minutes. Therefore this study aims at     investigating the role of blood and exhaled breath condensate oxidative stress biomarkers     before and after surgical lung resection for lung cancer in predicting subsequent clinical     outcome, i.e., timing of disease recurrence. Recruited subjects will undergo interval     sampling of blood and exhaled breath condensate, without any additional invasive     interventions. The study subjects will be followed up for 5 years for subsequent disease     recurrence.   "
236957|NCT00956865|"     The purpose of this study is to determine if one of three interventions improves follow-up     rates for screening exam participants who are instructed to have a definitive eye exam.   "
236958|NCT00956878|"     Cancer pain is common in advanced cancer patients. Opioids are the mainstay of treatment in     cancer pain. Responsiveness to and tolerability of opioids is, amongst others, determined by     small variations in human DNA. Using blood samples from clinically well-defined cancer pain     patients, the investigators are going to analyze single nucleotide polymorphisms (SNPs) in     genes that are known to be involved in responsiveness to opioids and sensitivity to pain.   "
236959|NCT00956891|"     The study aimed to investigate the short-term efficacy and long-term prognosis of liver     failure patients caused by hepatitis B after single transplantation with autologous marrow     mesenchymal stem cells (MMSCs). Liver failure inpatients caused by hepatitis B were recruited     and received the same medical treatments, among whom some patients underwent single     transplantation with autologous MMSCs and other patients with matched age, gender and     biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL),     prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were in control group. A     total of 120 ml bone marrow were obtained from patients, diluted and separated. Then MMSCs     suspension were slowly transfused into the liver through the proper hepatic artery by     interventional procedures. The levels of ALB, TBIL, PT and MELD score of patients in     translation group were compared with those in control group. In 3 ~ 48 months of follow-up,     differences in long-term outcomes such as incidence of HCC (hepatocellular carcinoma) and     mortality between two groups were compared.   "
236960|NCT00956904|"     A new solution for guiding the surgeon in robot-assisted laparoscopic radical prostatectomy     (RALP) is image-guided navigation using transrectal ultrasound (TRUS). A TRUS-guided     intraoperative navigation system using a robotic ultrasound probe manipulator (TRUS Robot)     has been developed. The proposed research is a pilot clinical trial of the TRUS Robot and     three-dimensional (3-D) navigation software to test its image-guidance ability of helping the     surgeon during RALP. This is a dual robot approach, a Tandem-RALP (T-RALP). The TRUS Robot     allows a steady holding as well as remote manipulation of the TRUS probe. In addition, the     TRUS Robot can track the accurate position of TRUS probe which allows 3-D reconstruction of     the images. While the intraoperative TRUS findings will not be used in surgical decision     making in this trial, the use of TRUS imaging during radical prostatectomy can potentially     improve the visualization of the NVB and subsequently improve postoperative recovery of     potency in men. In addition, the 3-D reconstruction images of the prostate gland can     potentially provide clear and accurate guidance of surgical landmarks to the surgeon..   "
236961|NCT00956917|"     The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance     analyzer is comparable to a predicate device in measuring human body composition.   "
236962|NCT00956930|"     RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and     keeping chemotherapy drugs near the tumor. Radioembolization kills tumor cells by blocking     the blood flow to the tumor and keeping radioactive substances near the tumor. It is not yet     known which treatment regimen is more effective in treating patients with liver cancer.      PURPOSE: This randomized phase II trial is studying radioembolization to see how well it     works compared with chemoembolization in treating patients with liver cancer that cannot be     treated with Radiofrequency Ablation or removed by surgery.   "
236963|NCT00956943|"     Unfortunately, the investigators still need to assess and identify novel ways to help people     quit smoking. Differences between people in terms of how fast they metabolize nicotine     influences response to transdermal nicotine patches, the most popular nicotine dependence     treatment, and it affects plasma levels of nicotine from treatment. These studies suggest     that fast metabolizers of nicotine may show better quit rates if they receive higher doses of     transdermal nicotine. This preliminary study is designed to assess, for the first time,     whether fast nicotine metabolizers show higher quit rates if given high dose transdermal     nicotine, versus standard dose. The study findings may help to support a subsequent large     trial to assess standard versus high dose transdermal nicotine for slow versus fast     metabolizers of nicotine, which may lead to a more personalized approach to treating nicotine     dependence using the nicotine patch to improve therapeutic benefits of transdermal nicotine.   "
236964|NCT00956956|"     The goals of this study are to evaluate the safety and tolerability of multiple ascending     doses of PF-04455242 administered orally to healthy adult subjects. In addition, the plasma     and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to     healthy adult subjects will be evaluated. Finally, the effect of multiple-doses of     PF-04455242 on serum prolactin concentration will be explored.   "
236965|NCT00956969|"     This interventional, randomized controlled study seeks to test the effects of a novel     emotional awareness and expression intervention against relaxation training or no     intervention for college students with chronic headaches. These two interventions are     conceptually quite distinct, as the former seeks to activate and process anger, whereas the     latter, more commonly used technique, seeks to suppress or avoid it.   "
236967|NCT00957008|"     Although weight loss programs are effective in the short-term, maintaining weight loss is     more challenging. Regularly tracking and logging physical activity (PA) and diet is related     to greater improvements in PA and diet and to greater weight loss over time. Receiving     continuous real-time feedback regarding calories burned and calories consumed could enhance     weight loss maintenance. This study will examine whether a device that provides such     feedback, called the SenseWear armband, enhances weight maintenance.      200 overweight adults aged 18 to 65 years will be randomly assigned to one of four groups:     (1) a standard behavior change weight loss group-based program (14 group sessions over a 4     month period followed by 6 phone calls over a 5 month period), (2) a standard behavior change     weight loss group-based program (15 group session over a 4 month period followed by 6 phone     calls over a 5 month period) combined with the armband, (3) the armband alone (training in     the use of the armband and a follow up telephone call), or (4) a self-directed weight loss     control group.      Participants will be recruited through USC through listserv emails, flyers, and worksite     advertisements. Interested individuals will take part in a telephone screen, an orientation,     a run-in visit (which includes 2 weeks of PA and dietary logging), a baseline assessment, and     a randomization visit. The intervention will then take place over a 9-month period with     eligible participants. Participants will take part in follow-up assessments at month 4 and 9.     Assessments at all three times will include questionnaires assessing diet, PA, psychosocial     factors related to diet and PA, and quality of life related measures. They will also have     their fasting blood drawn to assess lipids, glucose, and insulin, and staff will measure     their blood pressure, waist circumference (size), skinfold, height, and weight.   "
236968|NCT00957021|"     The purpose of this study is to evaluate the clinical outcomes (range of motion, pain,     function, radiographic stability, and health related quality of life) of patients receiving     the Triathlon® Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated     using pre-operative scores and comparing them to post-operative scores in addition to being     compared with cases who received the Scorpio® PS implant.   "
236969|NCT00957034|"     Heart failure (HF) is a complex condition resulting from structural or functional heart     diseases that impair the ability of the heart to fill with or pump out blood. The main     manifestations of HF are shortness of breath and tiredness which may limit the ability to     exercise or perform simple daily physical activities such as walking. Heart disease leading     to HF is associated with reduced muscle mass and reduced strength and low blood levels of     testosterone; a hormone normally produced by the human (male and female) body. Recent studies     have shown improvements of symptoms and ability to exercise in patients with heart failure     receiving testosterone.      This is a placebo controlled study to determine the efficacy and safety of low dose     testosterone (300 and 450 microgram/day) delivered by a transdermal system (patch) in women     with significant HF.   "
236970|NCT00957047|"     The primary objective of the study is to evaluate the efficacy of eslicarbazepine acetate     once-daily at doses of 400 mg, 800 mg and 1200 mg compared with placebo as adjunctive therapy     in patients with refractory partial epilepsy over a 12-week maintenance period. Patients who     complete Part I may enter a 1-year open-label extension.   "
236971|NCT00957060|"     Primary Objective:      To determine the superiority of glimepiride over sitagliptin in the reduction of HbA1c after     6 months of treatment in patients with monotherapy until the end of the trial.      Secondary Objective:      To evaluate the effect of glimepiride compared to sitagliptin in:      Glucose in fasting conditions; Postprandial glucose; Percentage of patients with HbA1c < 7%     and < 6.5%; Symptomatic Hypoglycemia; Body weight; Percentage of withdrawal and percentage of     patients with rescue therapy; Safety (adverse events and serious adverse events,     hypoglycemia, vital signs and laboratory results).   "
236972|NCT00957073|"     The purpose of the HOPE4HF trial is to demonstrate the safety and efficacy of the Rheos     Baroreflex Activation Therapy System in subjects with heart failure with an EF ≥ 40% in a     prospective, randomized trial.   "
236973|NCT00957086|"     The aim of the study is to improve the loco-regional control rate and overall survival of     locally advanced head and neck squamous carcinoma (HNSCC). The investigators hypothesize that     the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both     epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold     standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after     resection of their locally advanced HNSCC will confer therapeutic advantage.   "
236974|NCT00957099|"     Lay Summary      After patients are diagnosed with breast cancer, they undergo breast magnetic resonance (MR)     imaging to determine if the cancer is located in more than one place in the breast. Breast MR     imaging is a good option for this test because it has very high sensitivity (catches almost     all breast tumors). However, breast MR is slow: it takes about two minutes to acquire one     image, and is very low resolution. The points that make up the breast MR image are around 1     to 3 mm in size.      Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has     been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to     show the breast in its real three dimensional shape. Combined with the use of special     chemicals called iodine contrast enhancement, breast CT can provide images of both the     anatomy and the blood flow in the breast. As opposed to breast MR, breast CT is very fast. An     image can be taken in 10 seconds, and has very high resolution. The points in the breast CT     image are only 0.14 mm in size. The investigators propose to use breast CT instead of breast     MR imaging to determine if the patient's breast cancer is located in more than one place.     This is the first time anybody has proposed to use breast CT for this, so the investigators     aim to test the feasibility of the idea with only 6 patients.      Since the patients will undergo breast MR as part of the standard of care, the investigators     will be able to compare the breast CT images to the current standard, breast MR. This work     will lay a foundation for performing this very important test before breast cancer treatment     planning with a new, fast, high resolution imaging method, breast CT.   "
236975|NCT00957112|"     RATIONALE: Acupuncture may help relieve fatigue caused by breast cancer. It is not yet known     whether acupuncture is more effective than self-acupuncture in managing fatigue in women with     breast cancer.      PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works     compared with self-acupuncture in managing cancer-related fatigue in women who have received     chemotherapy for stage I, stage II, or stage IIIA breast cancer.   "
237024|NCT00957788|"     This research study involves an experimental drug (NST_001) and a delivery system. The main     purpose of this research study is to investigate the safety of NST-001, delivered directly to     the inner ear for the treatment of tinnitus.   "
237089|NCT00951184|"     RATIONALE: Gathering information about depression in patients with cancer may help doctors     learn more about the disease and plan the best treatment.      PURPOSE: This clinical trial is studying depression screening in patients undergoing     radiation therapy for cancer.   "
236976|NCT00957125|"     Patients with localized primary breast cancer including inflammatory breast cancer suitable     for primary medical treatment and/or regional lymph node metastases receive six cycles of     chemotherapy with epirubicin and docetaxel. Treatment evaluations are performed after the     second, fourth and sixth cycle. In case of SD/PR after the second course, bevacizumab is     added to the combination for the remaining four courses.      Besides standard response evaluation clinically and by mammography and ultrasound, several     functional imaging techniques including MR, CT-PET and contrast-enhanced ultrasound are     investigated. Fresh tumor tissue samples from the primary tumor are collected before start,     after two courses and in connection with surgery. The aim of the trial is to detect     biological factors and functional imaging techniques with the ability to predict response at     an early stage of treatment.   "
236977|NCT00957151|"     The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation     capability of patients with chronic pancreatitis.   "
236978|NCT00957164|"     The purpose of this study is to examine the efficacy of multiple treatment options in     addressing the co-morbidity between pain and PTSD symptoms. Recent research has suggested     that pain and PTSD co-morbidity presents unique problems for pain and PTSD treatment, and new     approaches are desperately needed to address this issue. To this end, the investigators hope     to identify the efficacy of a combined pain and PTSD psychosocial treatment protocol compared     to that of stand-alone psychosocial treatments for pain and PTSD. The primary measure for     treatment efficacy will be treatment-related changes in measures of psychosocial and     functional outcomes associated with chronic pain and PTSD conditions. The investigators will     additionally measure socioeconomic outcomes including return to pre-trauma job (or a job of     similar capacity), maintenance of active duty work at pre-trauma capacity for 6 and/or 12     months after return, and number of healthcare appointments made between follow-ups for pain     or PTSD treatment.   "
236979|NCT00957177|"     Pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing     elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device     for self delivering opioids. Morphine consumption in the first 48 hours is documented.      Hyperalgesia is measured by von-Frey-Filaments.   "
236980|NCT00957190|"     Diurnal and intervisit fluctuations in IOP are strongly associated with progression of open     angle glaucoma and therefore need to be minimized. Control of diurnal fluctuations of IOP     with different ocular hypotensive medications has been studied in some detail. But how do IOP     changes contribute to progressive glaucomatous optic nerve damage? It is reasonable to assume     that there are two principal effects of IOP changes. First, IOP fluctuations result in     changes in the stresses and strains on the ONH which in turn result in morphological changes     to the ONH. These morphological changes could in turn result in stretching and damage to     axons of the ONH. Secondly, IOP fluctuations results in changes to the forces acting on the     ONH vasculature, leading to changes in ONH vascular perfusion. These changes to perfusion     could in turn result in relative ischemia of the ONH and consequent ONH damage.      The investigators propose to monitor diurnal fluctuations in IOP and choroidal blood flow     (Pulsatile Ocular Blood Flow,POBF), and intervisit ONH topographical and blood flow     changes—ie to monitor the direct ONH consequences of IOP . Open angle glaucoma patients are     commonly prescribed topical latanoprost as first line therapy. The EXACCT study, for which I     was the principal investigator and which is now submitted for publication, demonstrated that     COSOPT was an efficacious choice as second line therapy for patients not controlled on     latanoprost monotherapy. The investigators will therefore recruit 20 OAG patients on     latanoprost monotherapy, perform diurnal curves of IOP, as well as a.m. ONH morphology and     ONH blood flow. Cosopt will then be added and at the next visit the same measurements will be     repeated.      The investigators expect that when Cosopt is added the investigators will demonstrate     improved IOP, morphology and blood flow compared to the latanoprost baseline. Furthermore the     investigators expect the the diurnal fluctuation of IOP and choroidal blood flow will be     stabilized on Cosopt therapy. The implications are that adding Cosopt to latanoprost can     stabilize not only the IOP but also the damaging consequences of IOP to the optic nerve head.   "
236981|NCT00957203|"     Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are     eligible to enter into this long-term study. The purpose of this study is to evaluate the     safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's     disease treated with levodopa.   "
236982|NCT00957216|"     This is a Physician-sponsored pilot study, whose purpose it is determine if high-dose oral     Coenzyme Q10 (CoQ10) is safe and tolerated in patients with sporadic forms of adult-onset     spinocerebellar ataxias (SAOA), a group of degenerative neurological disorders affecting the     cerebellum and pathways to and from the cerebellum, with or without additional central     nervous system (CNS) manifestations, in the absence of family history of degenerative     ataxias.   "
236983|NCT00957229|"     The purpose of this study is to reduce the number of new surgically eligible BCCs by 50%     appearing during month 3-18 of medication ingestion.   "
236984|NCT00957242|"     This study will test the effectiveness of warfarin in patients with IPF. Approximately 256     patients will be randomized 1:1 to either warfarin or placebo. Patients will return at week 1     for a safety review and every 16 weeks for 48 weeks. The primary endpoint in the study is the     time to either death, non-bleeding/non-elective hospitalization, or a drop of greater than     10% in forced vital capacity (FVC) from baseline.   "
236985|NCT00957255|"     Prospective, randomized, multi-center, controlled study for patients undergoing open rotator     cuff repair. Patients are stratified based on tear size to one of three groups. Each group is     then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT.   "
236986|NCT00957268|"     The purpose of this study is to determine the pharmacokinetic and safety profile of     alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.   "
236987|NCT00957281|"     Asthma is a chronic airway inflammation which involves the interplay of different types of     inflammatory cells and cytokines in the airway. The presence of systemic inflammation and     oxidative stress in asthma suggests that it has a propensity to develop cardiovascular     morbidity. Recent small scale studies have demonstrated that asthma severity may be     associated with both airway and systemic inflammation. The investigators' study aims at     linking asthma severity to airway and systemic inflammation, and subsequently to     cardiovascular morbidity if a significant association of the aforementioned is present. The     role of airway inflammation in contribution to systemic inflammation , and potential     interaction between these two conditions will also be studied.   "
237033|NCT00957905|"     This phase II trial is studying alvocidib and oxaliplatin to see how well they work when     given with or without fluorouracil and leucovorin calcium in treating patients with relapsed     or refractory germ cell tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin,     fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving alvocidib     together with oxaliplatin with or without fluorouracil and leucovorin calcium may kill more     tumor cells.   "
237034|NCT00957918|"     The study is designed to answer the question: will nicotine at doses that do not cause     serious side effects, show feasibility in treatment of levodopa-induced dyskinesia in     patients with Parkinson's disease?   "
236988|NCT00957294|"     The metabolic syndrome (MetS) is highly prevalent in patients with schizophrenia and is a     major risk factor of type-2 diabetes, cardiovascular disease and early death. Genetic     factors, antipsychotic medication, sleeping disturbances and unhealthy lifestyle are possible     causes of developing metabolic syndrome. Several studies have investigated the metabolic     side-effects of antipsychotic medication. However it is still unanswered how unhealthy     lifestyle, comprising physical inactivity, smoking, unhealthy dieting, and sleeping     disturbances adds to the metabolic risk of patients with schizophrenia. The aim of this study     is to investigate the prevalence and development of MetS in first-episode patients with     schizophrenia and 1 year after onset of treatment. The study's main hypothesis is that     physical inactivity, regardless of medication, is an independent risk factor for metabolic     syndrome in patients with schizophrenia. In comparison inpatients with major depression and     healthy controls, both matched on gender, age and level of education will be included in the     study. It is anticipated that the study's results will provide new knowledge about the risk     of developing metabolic syndrome in first-episode schizophrenia and how different risk     factors contribute to this.   "
236989|NCT00957307|"     Lay Summary      The American Cancer Society has recommended that all women over the age of 40 have an annual     mammogram for many years. This recommendation has been associated with a substantial decrease     in breast cancer deaths. When something suspicious is seen in one of these mammograms, the     woman is called back to the clinic for more imaging tests to better determine if that     suspicious feature might be breast cancer. These additional imaging tests include repeated     mammograms, magnification mammograms and/or ultrasound. Depending on what is seen in these     images, the radiologist will provide a diagnosis that the suspicion is probably cancer,     probably benign, or that the suspicion is a false alarm. If it is a false alarm, then the     woman is sent home and she should come back after a year for another standard annual     mammogram. If the diagnosis is that it is probably benign, then the woman should come back     after 6 months so that the suspicion can be tested again. If the diagnosis is that it is     probably cancer, the woman is recommended to have a biopsy so that the cancer can be     confirmed. Both fortunately and unfortunately, 80% of the biopsies turn out to be false     alarms. Although confirming that a woman does not have cancer is always a very good thing,     having put her through the anxiety, expense, and risk of a biopsy for what turned out to be     nothing should be avoided. Therefore, it would be desirable to reduce the number of     unnecessary biopsies that are performed.      Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has     been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to     show the breast in its real three dimensional shape. The investigators propose to use breast     CT as a new, better tool for the radiologist to perform the diagnosis, and therefore     hopefully result in fewer biopsies, which should decrease the false alarms. Before breast     CT can be used clinically as a diagnostic tool, extensive testing must be performed. In this     first step, the investigators propose to acquire breast CT images of only 10 patients that     have been recommended to have biopsies, to see if the radiologist would have arrived at a     different diagnosis if he/she had based his/her decision on the breast CT images. Since this     has never been attempted before, this is an initial small study to test the feasibility of     this method.   "
236990|NCT00957320|"     The goal of this study is to find a safe dose of sirolimus that can be used with a standard     dose of L-asparaginase. To find the safe dose, the investigators will give the first patient     a very small dose of sirolimus (smaller than the dose used in organ transplant children) and     the standard dose of L-asparaginase. The investigators will then look for side effects. If     side effects develop, the investigators will decrease the dose of sirolimus. If they do not,     the investigators will increase the dose of sirolimus in the next patient on the study. The     investigators will continue this method until fewer than one-third of patients have a side     effect that would require stopping the drug or changing the dose.      The investigators plan to enroll up to 15 children with relapsed ALL. The enrolled patients     must have recovered from other treatment before starting this study. Also, they cannot have     severe side effects from their earlier therapy that will possibly make these drugs less safe.      The investigators will collect information on whether these drugs help to cure the ALL, but     the purpose will be to find a dose of sirolimus that does not cause too many side effects     when combined with L-asparaginase. This will be explained to the families and they will sign     a written consent. The patients will provide either verbal or written assent when     appropriate.   "
236991|NCT00957333|"     This study is aimed to evaluate the relationship between ketamine abused and bladder     dysfunction and its possible mechanisms.   "
236992|NCT00957346|"     The primary goal of this study is to determine the clinical advantage of pre-treatment with     mifepristone in second trimester misoprostol induction abortion. This will be a randomized     controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus     misoprostol for second trimester (14-21 weeks' LMP) medical abortion.   "
236993|NCT00957359|"     The primary objective of this double-blind, placebo-controlled pilot study is to assess the     efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a     serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome     variable being anxiety associated with cancer. Secondary outcome measures will look at the     effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual     distress, attitudes towards disease progression and death, quality of life, and     spiritual/mystical states of consciousness. In addition, a secondary objective of the study     is to determine the feasibility of administering psilocybin to this patient population, with     regards to the following issues: safety, patient recruitment, consent for treatment, and     retention. The duration of the proposed investigation will be long enough to administer the     drug one time to each of thirty-two patients and to conduct follow-up assessments. This study     is separate but similar to a recently completed study at the Los Angeles Biomedical Research     Institute at Harbor-UCLA Medical Center, run by a psychiatrist, Dr. Charles Grob. Although     the outcomes measures would be similar to those used as in the Grob study, the proposed dose     of psilocybin is higher at 0.3mg/kg and the total subjects for the study would be 32 instead     of 12. The study utilizes a cross-over design at 7 weeks and includes prospective follow-up     of 6 months duration. This study has been approved by the Bellevue Psychiatry Research     Committee, the NYU Oncology PRMC Committee, the Food and Drug Administration (FDA) through     the issuance of an IND (77,138), the New York University School of Medicine Institutional     Review Board (NYU IRB), the Health and Hospitals Corporation (HHC)-New York University (NYU)     Clinical Translational Science Institute (CTSI), the NYU Bluestone Center for Clinical     Research, and the Drug Enforcement Agency (DEA) through the issuance of a schedule I license.      It is hypothesized that a one time experience with psilocybin will occasion dramatic shifts     in consciousness and awareness that will lead to short-term (ie hours to days) and long-term     (up to 6 months in this study, following the administration of the second dosing, either     psilocybin or placebo) improvement in anxiety, depression, and pain associated with advanced     cancer. The exact mechanism of action is unclear but based on studies done in the 60's using     serotonergic hallucinogens in patients with advanced cancer, improvements in anxiety levels,     mood and pain were reported. However, a treatment model developed by the famous British     psychiatrist Humphrey Osmond, offers one possibility. In this model, serotonergic     hallucinogens' therapeutic mechanism lies in their ability to allow the individual to access     novel dimensions of consciousness and their efficacy or lack thereof relies on whether a     transcendent and mystical state of awareness is attained. Another possible mechanism relates     to what Dobkin de Rios and Grob have described as 'managed altered states of consciousness,'     where the power of suggestibility, occurring in a safe setting, allows one to transcend a     particular state of consciousness (i.e. anxiety and depression associated with advanced     illness) as a means to facilitate emotional discharge and to manage irreconcilable conflict.   "
236994|NCT00957372|"     The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL)     administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in     patients with refractory partial epilepsy over a 12-week maintenance period.   "
236995|NCT00957385|"     The purpose of this study is to determine if Revlimid will help maintain patients with acute     myeloid leukemia in remission.   "
236996|NCT00957398|"     The hypothesis of the study is that the motility of the small intestine and the colon will     alter according to the subtype of the irritable bowel syndrome (IBS) patient.      IBS is currently classified into following subtypes:        -  Diarrhoea-IBS (IBS-D)        -  Constipation-IBS (IBS-C)        -  Mixed-IBS (IBS-M)        -  Unsubtyped-IBS (IBS-U)      according to the Bristol scale.      Magnetic Tracking System (MTS) is a new minimal invasive technic that allows motility studies     of the whole human gastrointestinal tract.      The magnetic cylindrical pill (6x15mm) is swallowed at 9 AM on day one. The recording is made     until 4 PM and again from 8 AM until 2 PM on day two. The patient is placed in a bed and will     be supplied with standardized food and fluid.      The Magnetic Tracking System consists of a 4 x 4 matrix of sensors positioned with respect to     the anatomical reference points. Before measurements, the matrix is calibrated by offsetting     the earth's and environmental magnetic fields. During the experiment, the magnet coordinates     are continuously monitored and transmitted to a computer for processing and storage.     Respiratory artifacts will be filtered out. Digestive movements will then be classified as 1)     non-propulsive or 2) propulsive and transformed into either trajectory or dynamic graphs of     the digestive motility.      The Magnetic Tracking System has the advantage from both radiographic and scintigraphic     methods of conducting the tests without any radiation exposure to the patient. Preliminary     studies have shown good concordance between the transit measured with the magnet and     radiographic transit times.      The investigators wish to use this method, MTS, to compare the motility of the small     intestine and the colon in patients with IBS-D and IBS-C as well as to compare these to     groups to MTS done on healthy volunteers under the same conditions as the IBS patients.   "
237047|NCT00958087|"     Sarcoidosis is a multi-systemic inflammatory disorder of unknown cause characterized by the     formation of non-caseating granulomas in involved organs. Its cardiac involvement may be     potentially fatal. Although endomyocardial biopsy is required for deﬁnitive diagnosis of     cardiac sarcoidosis, it is invasive and lacks sensitivity. The specific diagnostic tool for     cardiac sarcoidosis is far from satisfactory. Recent studies have revealed that FDG-PET with     under fasting conditions is a useful method for identiﬁcation of cardiac sarcoidosis     patients. However, to our knowledge, no investigations have been published with regard to FDG     quantification for the diagnosis and management of cardiac sarcoidosis by PET.   "
236997|NCT00957411|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to     grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances     to them. It is not yet known whether radiation therapy given together with cisplatin is more     effective with or without cetuximab in treating patients with cervical cancer.      PURPOSE: This randomized phase II trial is studying giving radiation therapy together with     cisplatin to see how well it works compared with radiation therapy and cisplatin given     together with cetuximab in treating patients with stage IB, stage II, or stage IIIB cervical     cancer.   "
236998|NCT00957424|"     RATIONALE: A study that evaluates participants' beliefs about smokeless tobacco products and     nicotine replacement therapy may be useful in helping smokers stop smoking.      PURPOSE: This clinical trial is studying the acceptability of less harmful alternatives to     cigarettes.   "
236999|NCT00957437|"     The purpose of this study is to evaluate the pharmacokinetics of different extended-release     formulations of AZD1305 when given as single and multiple oral doses to healthy male     volunteers.   "
237000|NCT00957450|"     Patients with cervix cancer having radiotherapy experience side-effects because the     radiotherapy fields have to be quite large to account for tumour movement in the pelvis     during treatment, this irradiates a lot of normal tissues. This study aims to characterize     and model the tumour motion, as well as the motion of surrounding normal tissues, during     treatment. By doing this, the investigators can look at ways to minimise tumour motion and     spare more normal tissues. By tailoring the radiotherapy dose more accurately, the     investigators will reduce the side-effects of treatment and improve local control of the     tumour. By doing multiple magnetic resonance imaging (MRI) scans of the patients during     treatment, the investigators can identify where the tumour and surrounding normal tissues are     at that point in time. Collecting all the information from these scans, will allow the     investigators to model the motion of the tumour and these pelvic organs, and investigate the     best way to target the tumour while still sparing normal tissues.   "
237001|NCT00957463|"     The hypothesis of this study is that either obstructive sleep apnea (OSA) or cigarette     smoking (CS) exposure would produce oxidative stress and inflammation leading to endothelial     injury, and the combined exposure would be additive or synergistic.   "
237002|NCT00957476|"     Randomized, double-blind placebo controlled trial of fish oil to decrease inflammation in     pregnancy.   "
237003|NCT00957489|"     Twin-Block treatment and Dynamax treatment for Class II division 1 malocclusion do not have     different effects with regards to treatment duration, the quality of dento-occlusal outcome,     skeletal and soft tissue profile, patient discomfort and gingival health.   "
237004|NCT00957502|"     This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue     approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be     used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be     implanted with product that has been aged for a specified amount of time.   "
237005|NCT00957528|"     The purpose of this study is to determine whether testosterone (male hormone) therapy is     effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing     in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body     composition, muscle metabolism, muscle strength, and bone metabolism.   "
237006|NCT00957541|"     The purpose of this study is to evaluate the performance of a new sensor-based diagnostic     feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This     trial will study the effectiveness of the diagnostic feature to detect heart failure events     in medically stable, ICD-indicated, congestive heart failure patients.   "
237007|NCT00957554|"     Primary Objective:      To demonstrate that the antihypertensive efficacy of the fixed combination     irbesartan/amlodipine 300/5 mg is superior to that of irbesartan 300 mg monotherapy in     lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM)     after 10 weeks of treatment (W10)      Secondary Objective:        -  To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine          300/5 mg with that of irbesartan 300 mg monotherapy after 10 weeks of treatment (W10)        -  To compare the antihypertensive efficacy of the fixed combination therapy          irbesartan/amlodipine 150/5 mg with that of irbesartan 150 mg monotherapy after 5 weeks          of treatment (W5)        -  To examine in each treatment group the change from week 5 to week 10 in SBP and          diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement          (OBPM)        -  To determine the incidence and severity of adverse events   "
237008|NCT00957567|"     Early diagnosis is one of the most important factors in the survival of patients diagnosed     with breast cancer. To aid in the early detection of breast cancer, a new technology, called     tomosynthesis imaging is being developed. The idea behind tomosynthesis imaging is to look     at the breast from different points of view by obtaining x-ray flat images from different     angles while the breast does not move, and then mathematically combine these flat images into     a three-dimensional image. The benefit of these three dimensional images is that the     radiologist can look at the different tissues of the breast in their real positions, as     opposed to all the tissues being flattened into a flat image, like that of a normal     mammogram. Since tomosynthesis images of the breast show the tissues in their real position,     the radiologist should be able to more easily find a tumor and also be able to reduce the     number of time he or she thinks there is a tumor present when in reality there is not one     there.      Before this new technology can be used in the clinic routinely, it is necessary to perform a     large number of studies to find the optimal way to use it. In this study, the investigators     are aiming to find how thick the slices or layers representing the breast should be in the     image when shown to the radiologist. The difference between these two thicknesses in how     useful the images are to the radiologist could be important. The investigators are trying to     determine if slicing the image of the breast into thicker slices will make the job of the     radiologist easier or not when deciding to recommend or not a biopsy (laboratory analysis) of     what the previous mammogram found. To find the answer to this question, the investigators     will image patients with their tomosynthesis machine and look at the tomosynthesis images     with the thin and thick slices. The radiologists that read each image will decide if they     would have recommended the patient to get a biopsy based only in each of these images. The     recommendations based on the images with thin slices and the recommendations based on the     images with thick slices will be compared with what was actually recommended using the     standard clinical tests. The investigators hope to find that the thicker slices help more     than the thinner slices when trying to decide if biopsy is needed or not.   "
237009|NCT00957580|"     This is an open-label, multi-center, dose-escalation trial of pimasertib (MSC1936369B) in     blood and bone marrow cancers. The trial will be conducted in two parts:      Part 1 (safety run-in period): Will determine the maximum tolerated dose (MTD) of the study     drug in subjects with advanced hematological malignancies.      Part 2: Will assess the anti-leukemic activity of the study drug in older subjects with newly     diagnosed poor prognosis acute myeloid leukemia (AML) who are not candidates for intensive     chemotherapy.   "
237010|NCT00957593|"     The investigators propose to perform a prospective randomized control trial to compare the     rate of cesarean delivery in women where Oxytocin (OT) is discontinued once active labor     begins (5 cm dilation) when compared with women where OT is continued at a maintenance level     per the usual protocol.      One study group will follow an oxytocin protocol which is incremental until 5 cm dilation and     then maintained at the same level throughout labor. The second arm will follow an oxytocin     protocol also incremental, but then discontinued once the cervix is 5 cm. The primary outcome     will be the rate of cesarean delivery between the groups. Secondary outcomes to be evaluated     will include duration of the labor, fetal heart rate abnormalities, and frequency of uterine     hyperstimulation, maternal and neonatal outcomes.      As mentioned in the study proposal, the proposed experimental arm is currently not performed     as part of the oxytocin guidelines at the investigators' institution. One study from Israel     suggests no difference in pregnancy outcomes with the proposed use of oxytocin. Although some     providers stop the oxytocin in active labor for their patients, this is not a commonly     performed procedure at the investigators' institution. The investigators are not aware of     other institutions employing the above practice.   "
237011|NCT00957606|"     The purpose of this study is        -  to determine the rate of osteoporosis among patients with advanced prostate cancer.        -  to propose an algorithm for early detection of patients with advanced prostate cancer          who are at risk of developing osteoporosis.   "
237012|NCT00957619|"     The investigators hypothecate that pentoxyfilline increase significantly the liver     regeneration and reduces significantly ischemia and reperfusion (I/R) injury in major liver     using aspartate aminotransferase (AST) and alanine aminotransferase (ALT) as marker of I/R     injury.   "
237013|NCT00957645|"     Part 1: The purpose of the first part of the study is to investigate the prevalence of pain     at stroke onset and 3 and 6 months after stroke in a consecutive cohort of stroke patients     admitted to a stroke unit.      Part 2: The purpose of the second part of the study is to identify patients who develop     central post-stroke pain within the first 6 months following stroke and to try to identify     early prognostic factors for the development of pain.   "
237014|NCT00957658|"     The purpose of this study is to evaluate clinical and radiographic outcome data in patients     implanted with the Accolade® TMZF® femoral stem.   "
237015|NCT00957671|"     Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires     hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by     GH stimulation testing. Moreover, abnormalities have also been established for the cortisol     and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients     with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle     function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH,     thyroid, cortisol).   "
237016|NCT00957684|"     This was a phase III 4-part study in multiple centres. Part I was a 26-week parallel-group,     randomised, placebo-controlled period (8 weeks single-blind placebo baseline, 2 weeks     double-blind titration, 12 weeks maintenance, and 4 weeks tapering off). After completing the     baseline period, patients were randomised in a 1:1:1:1 ratio to 1 of 3 ESL dose levels or to     placebo. Part II was a 1-year open-label extension for patients who had completed Part I. The     starting dose was 800 mg once daily and could be titrated up or down at 400-mg intervals     between 400 and 1200 mg. Part III was an additional 1-year open-label extension for patients     who had completed Part II, had participated in the post-Part II study extension, which     allowed patients to continue treatment with ESL, or had continued to take ESL in a     compassionate use program. ESL starting doses were the same as received at the end of Part     II, during post-Part II study extension, or under compassionate use, and could be titrated up     or down at 400-mg intervals between 400 and 1200 mg once daily. Part IV was a study extension     to allow patients to continue ESL treatment after the end of Part III until marketing     authorisation or discontinuation of clinical development.   "
237017|NCT00957697|"     The purpose of this study is to investigate the prevalence of characteristics of pain in a     cohort of patients with prior stroke suspected of having central post stroke pain, identified     through a postal questionnaire.   "
237018|NCT00957710|"     Progressive aphasia is characterized by a steady and progressive loss of language skills in     the presence of relatively preserved memory, attention, and thinking. The aim of this study     is to slow the progression of language decline in progressive aphasia via language therapy.     The first goal of this study is to improve naming abilities of individuals with progressive     aphasia. This will be accomplished by carrying out an intensive treatment program for anomia.     The second goal is to evaluate whether this intense language treatment re-activates affected     areas and/or connections within the language network, using functional Magnetic Resonance     Imaging (to measure neural activity in specific brain regions) and Diffusion Tensor Imaging     tractography (to measure the connectivity between specific brain regions). This is the first     study on progressive aphasia addressing both treatment and imaging in the same patients.   "
237019|NCT00957723|"     The purpose of this study is to evaluate the clinical outcomes (range of motion, pain,     function, radiographic stability, and health related quality of life) of patients receiving     the Triathlon® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by     comparing pre-operative to post-operative scores, as well as to a control group. The control     group is the Scorpio® CR Total Knee System.   "
237020|NCT00957736|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to chronic     graft-versus-host disease in patients who have undergone donor stem cell transplant.      PURPOSE: This phase I trial is studying chronic graft-versus-host disease in patients who     have undergone donor stem cell transplant.   "
237021|NCT00957749|"     Molybdenum Cofactor Deficiency Type A (MoCD) is a very rare autosomal recessive disorder that     is essentially fatal early in life. Naturally occurring cPMP is present in the body of all     healthy normal individuals. It is processed to molybdopterin, which is further processed to     molybdenum cofactor. Molybdenum cofactor is essential for the function of important enzymes.      There is currently no treatment for MoCD, and affected infants develop severe neurological     damage which often results in infant death.      This study is the first clinical trial to investigate the potential of replacement of cPMP to     infants with MoCD Type A. The safety, tolerability, and pharmacodynamics of daily intravenous     administration of cPMP over 3 months will be determined.   "
237025|NCT00957801|"     Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level     that compromises health and quality of life. Age-associated increases in cytokine and     inflammatory signaling may be important contributors to this process. In this project the     investigators will test the hypotheses that 1) testosterone will inhibit cytokine and     inflammatory signaling in skeletal muscles of older adults and 2) will augment the anabolic     response to increased skeletal muscle activity. The investigators will also assess the     practical question of whether testosterone injection and gel application elicit similar     responses. Resistance exercise will be used as a means of stimulating both inflammatory and     anabolic responses in skeletal muscle. In order to assess the effects of testosterone on     these responses, fourteen subjects will perform resistance exercise on two occasions     separated by 7 days. The first session will be performed prior to the initiation of     testosterone therapy and the second session will be performed after receiving testosterone     for 7 days.   "
237026|NCT00957814|"     The nutritional systematic orientations in outpatients with heart failure throughout 1 year     in comparison to conventional treatment is estimated to lead to higher nutritional treatment     adherence and improved nutritional status, clinical and life quality parameters.   "
237027|NCT00957827|"     Facial lacerations are a commonly encountered problem in the emergency department. Despite     this, few original articles have been written concerning the management of lacerations of the     lip which communicate with the oral cavity. Specifically, no study has been able to     definitively show whether the use of antibiotics for these wounds decreases the infection     rate. These cutaneous wounds are a unique type of laceration because they are continuously     contaminated with oropharyngeal flora. Contaminated wounds result in larger, less cosmetic     scars. Scars which involve the face have been shown to have a negative psychological impact.     In this study, the investigators aim to determine whether the use of antibiotics decrease the     rate of infection in lacerations of the lip which communicate with the oral cavity. Patients     will be randomized to one of two currently practiced therapies. Patients will receive either     cephalexin or no treatment following the repair of their through-and-through lip lacerations     to determine whether antibiotics decrease the infection rate in these wounds.   "
237028|NCT00957840|"     Intraventricular hemorrhage and its resultant post-hemorrhagic hydrocephalus are significant     risk factors for the development of neurodevelopmental delays in preterm infants. The purpose     of this study is to determine 1) the incidence of progressive post-hemorrhagic ventricular     dilatation (PHVD) in infants with severe intraventricular hemorrhage (IVH), 2) the effect of     ventricular dilatation on brain status (cerebral oxygenation, electrical activity, and     biomarkers of cerebral damage and repair), and 3) if using ventricular measurements, derived     from cranial ultrasound to guide removal of cerebral-spinal fluid through an Omaya reservoir,     will help resolve ventricular dilatation and decrease the need for ventriculo-peritoneal (VP)     shunt insertion. The hypothesis of this research project is that, by using ventricular     measurements to guide the frequency of CSF removal, the rate of VP shunt insertion will be     decreased in preterm infants with severe IVH and PHVD. The investigators further hypothesize     that cerebral injury, as measured by cerebrospinal fluid (CSF) concentration of biomarkers of     neuronal and glial damage and inflammation, will decrease over time with resolution of PHVD.   "
237029|NCT00957853|"     The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery     for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may     cause changes in biomarkers. Biomarkers are chemical markers in the blood and/or tissue     that may be related to a reaction to study treatment.      The safety of the study treatments will also be studied.   "
237030|NCT00957866|"     Background:      According to recent estimates, the prevalence of Chronic Hepatitis C (CHC) in Canada is three     times more common in First Nations (FN)and Metis compared to non-FN populations. Moreover,     once infected, the progression of CHC to cirrhosis and/or hepatocellular carcinoma is greater     in FN patients due to the increased prevalence of alcohol abuse, obesity and diabetes in this     segment of the population.      Research Plan:      This research proposal consists of three parts. The objective of Part I is to document the     response to anti-viral treatment for CHC among treatment-naïve FN and Metis and Caucasian     (hereafter referred to as non-FN) patients residing in three urban Western Canadian centres     (Winnipeg, Saskatoon and Regina). Demographic, clinical and response to treatment data in a     total of 160 patients (80/group) will be collected at the above centres and transferred to     the Section of Hepatology at the University of Manitoba for statistical analyses. In Part II,     the applicants will document and compare the immune responses to HCV proteins throughout the     course of therapy in FN, Metis and non-FN patients. In the final part, direct economic costs     of CHC care in FN, Metis and non-FN patients will be ascertained and future costs predicted.      Hypotheses:      Part I - The rate of sustained virologic response (SVR) to treatment for CHC is higher in FN     and Metis compared to non-FN and no Metis patients.      Part II - The immune response to HCV proteins during anti-viral therapy for CHC is enhanced     in FN and Metis compared to non-FN and non-Metis patients.      Part III - The direct costs of health care utilization and delivery for CHC are similar among     FN and Metis and non-FN and non- Metis patients.   "
237031|NCT00957879|"     Fibroblast growth factor 23 (FGF23) is a new hormone which controls phosphate and vitamin D     levels in humans. Excess FGF23 is associated with an increased risk of death in patients with     chronic kidney disease. In this study the investigators are investigating the effects of     different forms of vitamin D on FGF23 levels in the blood in order to increase our     understanding of how this important hormone works.   "
237032|NCT00957892|"     There is a paucity of information on whether and how the composition of formulas fed to     infants influences their short-term feeding behaviors during the first few months of life.     The purpose of this study is to investigate whether the composition of infant formula affects     infants' feeding behaviors, in particular, how much formula is consumed within a given feed     (i.e., measure of satiation) and how much time elapses after the feed until the infant     exhibits signs of hunger (i.e., measure of satiety). The investigators will also examine the     relationship between the composition of infant formula consumed and infant temperature,     activity, sleep, and mothers' perceptions of infants' intake and regulatory behaviors.   "
237303|NCT00964041|"     This is a parallel-group, placebo-controlled trial examining the cognitive effects at weeks     1, 4, & 8 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for     8 weeks in adult outpatients with schizophrenia.   "
237035|NCT00957931|"     The main purpose of this project is to cure patients with high risk Sickle cell disease and     other red cell disorders including thalassemia and diamond-blackfan anemia by bone marrow     transplantation. The patients enrolled in this study will be those who lack matched sibling     donors and therefore have no other option but to undergo bone marrow transplantation using     matched but unrelated bone marrow or umbilical cord blood from the national marrow donor     program registry. Since bone marrow transplantation for these disorders using matched     unrelated donors has two major problems i.e. engraftment, or , the process of new marrow     being accepted and allowed to grow in the the patient; and graft-versus-host disease, or the     process where the new marrow rejects the host or the patient, this study has been devised     with methods to overcome these two problems and thus make transplantation from unrelated     donors both successful in terms of engraftment and safe in terms of side effects, both acute     and long term.      In order to accomplish these two goals, two important things will be done. Firstly, patients     will get three medicines which are considered reduced intensity because they are not known to     cause the serious organ damage seen with conventional chemotherapy. These medicines, however,     do cause intense immune suppression so these can cause increased infections. Secondly, in     addition to transplantation of bone marrow from unrelated donors, patients will also     transplanted with mesenchymal stromal cells derived from the bone marrow of their parents.     Mesenchymal stromal cells are adult stem cells that are normally found in the bone marrow and     are thought to create the right background for the blood cells to grow. They have been shown     in many animal and human studies to improve engraftment. In addition, they have a special     property by which they prevent and are now even considered to treat graft versus host     disease. Therefore, by using a reduced intensity chemotherapy regimen before transplant and     transplanting mesenchymal stromal cells, we hope to improve engraftment while at the same     time decrease the potential for severe side effects associated with a conventional transplant     which uses extremely high doses of chemotherapy.   "
237036|NCT00957944|"     The major aim of this study is to investigate and compare the drug amount delivered to the     body after sequential application of 2 rotigotine transdermal patches from 2 different     manufacturing sites.   "
237037|NCT00957957|"     This study will examine changes in various gut-derived hormones in obese type 2 diabetic     patients before and after elective bariatric surgery.   "
237038|NCT00957970|"     The purpose of this study is to determine if there is a difference in stress shielding and     bone resorption of the proximal femur in two anatomical stem total hip designs.   "
237039|NCT00957983|"     The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the     headache expected during a Prostaglandin E2 infusion.   "
237040|NCT00957996|"     This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and     tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected     influenza infection.   "
237041|NCT00958009|"     The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b)     multiple domains related to subject's acceptability and satisfaction, and c) reliability of     the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing     multiple sclerosis (RMS).   "
237042|NCT00958022|"     The subjects are being asked to take part in the Phase I or Phase II portion of a research     study of a new investigational drug, LBH589, in combination with chemotherapeutic agents,     carboplatin with etoposide. LBH589 (made by Novartis Pharmaceuticals Corp.) is considered     investigational because it has not been approved for commercial use in the treatment of     cancer by the U.S. Food and Drug Administration (FDA). Etoposide and carboplatin are     chemotherapeutic agents approved by the FDA for the treatment of for small cell lung cancer.      LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by     blocking certain enzymes (proteins produced by cells). LBH589 has shown effects against     cancer in laboratory studies and in studies using animals; however, it is not known if this     medicine will show the same activity in humans. As of May 2006, approximately 100 patients     have received treatment with either an intravenous or capsule form of LBH589. Only the     capsule form of LBH589 will be used in this study.      The main goal during the Phase I portion of this research study is to find out the highest     and safest dose of LBH589 that can be given in combination with carboplatin with etoposide in     subjects with lung cancer without causing severe side effects. The main goal of the Phase II     portion of this study is to find how the subject's lung cancer responds to the LBH589 in     combination with carboplatin and etoposide at the highest and safest dose that was given in     Phase I.      The subject may be enrolled in either Phase I or Phase II of the trial, depending on when     they entered the study, but they will not be enrolled in both phases.      This study will also investigate how the subject's body processes the combination of LBH589     and carboplatin with etoposide. To determine this, the investigators will measure the amount     of study drug in the subject's blood. This will be done with a series of blood tests, called     pharmacokinetic (PK) tests. Pharmacokinetics is the study of how the study drug moves through     the body. Other purposes of this study will be to sample the subject's genetic material     (DNA/RNA) as well as to determine biomarkers in their blood. (For some cancers, biomarkers     are a way to measure the extent of their disease or the effects of treatment.) These samples     will also be stored for future studies.   "
237043|NCT00958035|"     This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to     the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in     increasing overall eyelash prominence in self-identified African American/ethnic black     subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).   "
237044|NCT00958048|"     Specific aims:      Aim 1. To determine the incidence of hypoventilation in Amyotrophic Lateral Sclerosis (ALS)     patients.      Aim 2. To identify the clinical characteristics and risk factors associated .      Aim 3. To determine the effect of early intervention with nocturnal NIV on the prognosis of     ALS patients.   "
237045|NCT00958061|"     Little is known about the long-term health and mental health status of women Vietnam     veterans. For many of these women, the effects of this war are still present in their daily     lives. As these women approach their mid-sixties, it is important to understand the impact of     wartime deployment on health and mental health outcomes nearly 40 years later. The     investigators propose to assess the prevalence of posttraumatic stress disorder (PTSD) and     other mental and physical health conditions for women Vietnam veterans, and to explore the     relationship between PTSD and other conditions and the Vietnam deployment experience. The     investigators are interested in studying women Vietnam veterans who may have had direct     exposure to traumatic events. For the first time, the investigators also want to study those     who served in facilities near Vietnam. These women may have had similar, but less direct     exposures. This cross-sectional study will seek to contact approximately 10,000 women for     participation in a mailed survey, telephone interview and a review of their medical records.     Women identified as serving in Vietnam, near Vietnam (in Asia during the Vietnam Ware) and in     the U.S. during the Vietnam War will be identified from an established cohort and sent a     survey on demographics, behaviors, disability, health-related quality of life, and medical     conditions. Women agreeing to be contacted will also be interviewed by study investigators     using the modified CIDI to ascertain current and lifetime mental health conditions (including     PTSD) and exposure to traumatic events. A more extensive chart review will be conducted by a     clinician to validate self-report of key medical conditions.   "
237046|NCT00958074|"     This phase II trial studies the side effects and how well vorinostat works in treating     patients with primary cutaneous T-cell lymphoma. Vorinostat may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth   "
237048|NCT00958100|"     This study aims to verify the persistent control of the virus replication at 48 weeks after     the simplification to tenofovir + emtricitabine + raltegravir or to     lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any     virological failure to previous combined antiretroviral therapies needing a therapeutic     switch for toxicity related issues or adverse events.   "
237049|NCT00958113|"     The hypothesis of this project is that specific genes can be identified that contribute to     genetic susceptibility to autoimmune thyroid disease (AITD) in different populations. The     specific aim of this project is carry out one or more genomewide association studies (GWAS)     to map and ultimately identify genes that confer susceptibility to AITD. AITD consists     principally of Hashimoto's Thyroiditis (HT) and Graves' Disease (GD), characterized     clinically generally by hypothyroidism and hyperthyroidism, respectively. Both HT and GD are     autoimmune diseases characterized by infiltration of the thyroid by T and B cells that are     reactive with thyroid antigens and by the production of thyroid autoantibodies (TAB). While     there is some evidence that there may be genes specific to either GD or HT, other genes     appear to be common to both, and some genes may furthermore be in common to susceptibility to     other autoimmune diseases. Genes known to play a role in AITD include HLA, CTLA4,     thyroglobulin (TG), THSR, and CD40, PTPN2, and PTPN22, several of which are also involved in     susceptibility to other autoimmune diseases. All of these genes interact in a complex manner     that has yet to be understood. Furthermore, it seems clear that relatively few of the genes     involved in susceptibility to AITD have thus far been discovered.   "
237050|NCT00958126|"     The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for     eliciting an immune response to H1N1 influenza in healthy adults   "
237051|NCT00958139|"     Hypothesis: Does treatment of lower extremity clothing with permethrin prevent Lyme disease?      This is a double-blind, randomized clinical trial using permethrin treatment of clothing to     prevent Lyme disease.   "
237052|NCT00958152|"     The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of     the co-administration of VCH-222 and telaprevir in healthy subjects.   "
237053|NCT00958165|"     The purpose of this study is to determine the safety and effectiveness of the endoscopic     ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF)     with pulmonary vein isolation (PVI).   "
237054|NCT00958178|"     The purpose of this study is to determine whether rebreathing for a short time (a bit like     breathing into a paper bag) will stimulate faster breathing and thus make the giving of     Oxygen more effective.      The hypothesis is that the investigators method (rebreathing) will be faster than the current     method of administering Oxygen.   "
237055|NCT00958191|"     The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3     polyethylene insert are superior to a polyethylene control group wear rate at 5 years     postoperative. This measurement will be evaluated by comparing digitized images of serial     radiographs obtained over a follow-up period of 5-years.   "
237056|NCT00958204|"     This study will investigate the additional benefits of light and ion therapy as added     treatments to an antidepressant (fluoxetine) in subjects with major depressive disorder     (MDD), versus treatment with fluoxetine alone. Outcomes will include depressive symptom     rating scales and measures of quality of life, work absence and productivity, and use of     health care services. The primary hypotheses are that, in patients with nonseasonal major     depressive disorder (MDD) of at least moderate severity: 1) bright light therapy or negative     ion therapy will be superior to a placebo condition in reducing symptoms of depression, and     2) the combination of fluoxetine and either bright light or negative ion therapy is more     effective than either monotherapy condition.   "
237057|NCT00958217|"     This study will compare two different types of psychotherapy for Veterans with depression,     addiction, and a past traumatic experience. Everyone in the study will receive 12 weeks of     group cognitive behavioral therapy focused on depression and addiction, followed by 12 weeks     of individual psychotherapy sessions. For the second 12 weeks, half of the people will     receive a review of the initial therapy, and half will receive a cognitive behavioral therapy     focused on trauma. Everyone will complete research interviews every 3 months for a total of     18 months.   "
237058|NCT00958230|"     The study is designed to produce early safety and performance data in a small group of     patients requiring repair of a peripheral vascular endarterectomy (incision into an artery     feeding the limbs which requires a patch to repair the incision after removal of an     atherosclerotic plaque that was stopping usual blood flow to the limbs).      Data is being collected to show the procedure is safe and allows for normal blood flow to be     resumed.      Data will be used to facilitate CE Mark submission.   "
237059|NCT00958243|"     The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425     (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.   "
237060|NCT00958256|"     The goal of this clinical research study is to learn if bortezomib when given in combination     with cyclophosphamide and rituximab can help to control mantle cell lymphoma. The safety of     this drug combination will also continue to be studied.   "
237061|NCT00958269|"     The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2     diabetic subjects with moderate or severe renal impairment.   "
237062|NCT00958282|"     This protocol is a 2-group double-blind placebo-controlled outpatient study investigating     lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100     subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and     secondary objectives will be cocaine craving and impulsivity.   "
237077|NCT00958477|"     This study is intended to test an experimental new drug called, EMD 525797 (Study Drug). This     drug is not yet approved for sale and has only been tested in a small number of people to     date (prior to this study starting another research study was carried out involving 37     healthy volunteers receiving the Study Drug). Until more is known about this Study Drug, it     can only be used in research studies.      This research study is planned to answer important questions about how the Study Drug is     tolerated and how it may work in patients with prostate cancer with bone metastases.      This is a small study which is expected to include 24 patients, and will be conducted in     approximately 3 hospitals in Germany and 1 hospital in Brussels, Belgium. The study will last     until the last patient has had their last study visit which is expected to be about 18 months     in total.   "
237124|NCT00951639|"     The purpose of this study was to compare the acute effects of 5g of Cassia cinnamon, 50     minutes of endurance exercise performed at 70% of the heart rate reserve (correlated to     VO2max), and 5g of cellulose placebo on blood glucose, serum insulin and insulin sensitivity     following an oral glucose tolerance test 3 hours after administration of each intervention.   "
237063|NCT00958295|"     Acute uncomplicated bacterial cystitis is common in general practice. Cystitis is at the     second raw of antibiotic treatment indications. It has been now recommended not to perform     any urine culture for more than 20 years; hence, the bacterial epidemiology of acute     uncomplicated cystitis is surprisingly relatively unknown. The available bacteriological data     mainly describe the epidemiology of complicated urinary tract infections or upper urinary     tract infections, but the causative bacteria and the resistance rates might differ from those     of uncomplicated cystitis. As an example, it is unknown to what extent Staphylococcus     saprophyticus is the causative agent of uncomplicated cystitis.      Moreover, the urine dipstick test have been evaluated in laboratories. But their     interpretation in current practice might not be so easy: in particular, the nitrite detection     depends on the bacterial concentration. The nitrite detection, produced in enterobacteriaceae     related infections might have therapeutical consequences: trométamol-fosfomycine is almost     constantly active on enterobacteriaceae, but ineffective on staphylococci. Knowing the     increasing prevalence of fluoroquinolone-resistant enterobacteriaceae, the use of fosfomycin     in nitrite positive uncomplicated cystitis might preserve the susceptibility of     fluoroquinolones during pyelonephritis.      This study will describe:        -  the bacterial epidemiology of acute uncomplicated cystitis in general practice,        -  the correlation in between urine dipstick and urine culture in general practice,        -  the prediction of enterobacterial infection by the nitrite detection, AND        -  the antibiotics prescribed by the practitioners for uncomplicated acute cystitis.   "
237064|NCT00958308|"     The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the     prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated     Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.   "
237065|NCT00958321|"     RATIONALE: Diagnostic procedures, such as positron emission tomography and computed     tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional     conformal radiation therapy.      PURPOSE: This phase II trial is studying the side effects of positron emission tomography and     computed tomography and to see how well it works in planning treatment for patients     undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that     cannot be removed by surgery.      This is a clinical study, as the patient will be treated using the PET-CT-GTV: - The pilot     study is investigating the technological feasibility - The Phase II study will be a 2-stage     Phase II study   "
237066|NCT00958334|"     ZPU-003 EXT is a 2-year extension study of ZPU-003 to determine the continued safety and     efficacy of Proellex in women who have previously completed the double-blind portion of the     study.   "
237067|NCT00958347|"     The purpose of this study was to obtain up to 25 year post-operative data on the Omnifit     Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system     for reducing implant loosening, permitting tissue bonding onto the hydroxylapatite surfaces     of the implant and providing a safe, efficient, and well-functioning hip in a wide spectrum     of clinical circumstances.   "
237068|NCT00958360|"     This study will determine if the interdisciplinary team low vision rehabilitation program is     more effective than basic low vision care provided by an optometrist working alone in     improving visual reading ability in veterans with macular diseases and best corrected visual     acuity of 20/50 to 20/200.   "
237069|NCT00958373|"     The purpose of this pilot study is to determine the presence, frequency, and severity of     mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.   "
237070|NCT00958386|"     The purpose of the study is to evaluate the efficacy and safety of the combination of     Panitumumab with Irinotecan in patients with Wild-Type KRAS metastatic colorectal cancer     refractory to irinotecan based chemotherapy.   "
237071|NCT00958399|"     Research suggests dietary fiber may play a role in weight management, and fiber consumption     is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These     effects may be mediated by increased satiety, reduced food intake, or changes in blood levels     of glucose, insulin, and gut hormones.      The purpose of this study is to determine the satiety, glycemic, hormonal, and     gastrointestinal responses of novel fiber supplements.   "
237072|NCT00958412|"     This is an extension of the phase II, three-arm, parallel design, dose-ranging,     placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1)     of two (2) dose levels of Proellex® was administered once-daily for four (4) months.   "
237073|NCT00958425|"     The purpose of this study is to determine the efficacy of hyaluronic acid gel injections     compared to saline injections in improving scar quality in patients undergoing breast     reduction surgery. Hyaluronic acid has been implicated in scarless fetal healing, and the     investigators therefore hypothesize that injections of hyaluronic acid gel into breast     reduction incisions will improve their appearance compared to injections of saline.   "
237074|NCT00958438|"     The purpose of this clinical research study was to determine the safety and effectiveness of     an experimental drug called rilonacept in participants with gout who are beginning     allopurinol treatment for gout. Participants will participate in this study for approximately     22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.   "
237075|NCT00958451|"     This is an open label, single center, randomized, active comparator controlled study,     comparing the effects of vitamin D replacement using oral ergocalciferol versus paricalcitol     on parathyroid hormone (PTH) levels in patients with stage 3 and 4 CKD and vitamin D     deficiency or insufficiency. The purpose of this study is to determine which of these two     approaches is more successful.   "
237076|NCT00958464|"     The purpose of this study is to determine whether Perthes' disease has caused detectable hip     cartilage damage in young people who have reached the healed stage of the disease.   "
237088|NCT00951171|"     Study Hypothesis: There is a difference in pregnancy rates between intrauterine insemination     (IUI) in cycles performed with cervical occlusion by a balloon catheter designed for     sonohysterograms as compared to those performed with a standard inseminator.      The investigators will compare pregnancy rates in patients undergoing routine IUI either with     balloon occlusion or with standard insemination. The patients will receive the standard     clinical care per the investigators' office guidelines, except they will be randomized to     insemination with either of two catheters.   "
237333|NCT00964431|"     The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are     safe and effective for the treatment of dental pain.   "
237078|NCT00958490|"     Overall Objective: To evaluate the efficacy of an interventional walking program on the     quality of life and functional status of patients with Lumbar Spinal Stenosis, post-surgery,     using subjective (VAS, ODI, RMDQ, SF-36), and objective measures (triaxial accelerometry,     step count, weight).      Design and Methods: Two groups of subjects will be examined; patients diagnosed with lumbar     spinal stenosis (LSS) that progress to surgical management, with one group of subjects     staring on the walking program at 2 months postop, and the other group starting on the     walking program at 3 months postop.      Subjects who agree to participate will be assessed (assessments listed below) after the     diagnosis preoperatively and 2 months postoperatively. One half of the group will start the     walking program at the 2 months postop visit and be assessed again at the end of the walking     program, the other half will be assessed again at 3 months postop and start the walking     program at that time and be assessed again at 4 months postop. All subjects will be contacted     by phone during their walking program to allow for questions from the subjects and to offer     support and encouragement. Subjects will be given instructions and a daily diary to track     steps taken each day (appendix A).      Subjects will be recruited from the referrals to the practices of the Orthopedic and     Neurosurgery Spine Surgeons at the Health Sciences Centre in Winnipeg. This encompasses the     majority of new and currently managed cases in the Manitoba and Northwestern Ontario.      Subjects will be between the ages of 18 and 90. Male and female subjects will be recruited     into the study. All LSS patients will demonstrate intractable neurogenic claudication and     radiographically confirmed lumbar spinal stenosis. Exclusion criteria will be any previous     lumbar spine surgery, the existence of significant co-morbidity (e.g. neurologic or cardiac     condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal     injury) preventing the subject from participating in regular activity and the walking     program. Subjects participating will be required to speak English.   "
237079|NCT00958503|"     The purpose of this study is to determine if two-weeks of dosing with thiamphenicol is safe     and is able to change the levels of certain pre-specified biomarkers in nervous tissue taken     from the nasal passages.   "
237080|NCT00958516|"     The purpose of this trial is to evaluate the phototoxic potential of a single application on     healthy skin of LEO 29102 cream in different doses.   "
237081|NCT00958529|"     The intake of inulin products has been linked to multiple health benefits which has lead to     inulin fortification in food products.      The investigators hypothesis that doses of up to 10 grams of inulin products should be well     tolerated and not result in a significant increase in gastrointestinal symptoms.   "
237082|NCT00958542|"     This is a prospective, multi-centre study that will be looking at two groups of males and     females over the course of their operative treatment for cerebral palsy (CP) scoliosis and     the years following that treatment. The first group the study will be looking at is those     individuals who undergo surgery for CP Scoliosis. The second group will be those individuals     who do not undergo surgical treatment for CP Scoliosis, either because the family declines     surgery or surgery is not recommended during the course of study participation.   "
237083|NCT00945828|"     Neurodevelopmental outcomes in children treated for cancer involving the central nervous     system (CNS) provide educators with new challenges with regards to classification,     monitoring, and intervention in the regular or special education classroom setting.     Recommendations resulting from serial neurodevelopmental evaluations for these children often     do not overlap with traditional special education recommendations commonly included in     Individual Education Plans (IEPs) for children with congenital or genetic learning problems.     The investigators currently do not know whether or not school-based treatment for learning     problems, based on the child's IEP, incorporates recommendations made based on a     neurodevelopmental evaluation appropriately. In addition, it is not clear whether or not the     recommendations that are included in a child's IEP have any beneficial outcome on the child's     learning and academic achievement over time. The purpose of this project is to examine the     relationship between neurodevelopmental outcomes, recommendations for intervention, special     education services and accommodations included in a child's school IEP, and outcome for the     child following implementation of the IEP. The study has two major specific aims:        1. To quantify the clinical and educational contributions of recommendations resulting from          neurodevelopmental evaluations and the subsequent development of IEPs.           Hypothesis 1.1: Higher concordance between recommendations made based on          neurodevelopmental evaluations and criteria written into children's IEPs will be          associated with more positive academic outcomes (i.e. maintenance or improvement in          academic skills).           Hypothesis 1.2: Children who have higher concordance between criteria written into their          IEPs and academic services actually received will show more positive academic outcomes          than children whose IEP criteria and academic services are less concordant.        2. To evaluate an intervention that will improve academic outcomes for children treated for          cancer.      Hypothesis 2.1: Children whose IEPs are monitored more frequently will show more positive     academic outcomes than their peers whose IEPs are monitored less frequently.   "
237084|NCT00951119|"     Rationale: Hypertension is an important risk factor of cardiovascular disease, especially in     patients with type 2 diabetes mellitus (T2DM). A relatively recent development for the     treatment of hypertension is the use of breathing exercises. The investigators' previous     studies with a breathing device did not show any positive results. However, these studies and     other trials investigating the effects of breathing devices had not a double-blind design.     Therefore, the investigators want to perform a randomized, double-blind, controlled trial in     a population of T2DM patients.      Objective: To determine the effect of a device slowing breathing (Resperate©) on office     systolic blood pressure (SBP) in diabetic patients with treated hypertension with moderate BP     control.      Study design: A randomized, double-blind, controlled trial.      Study population: Patients with type 2 diabetes mellitus, over 18 years old and a baseline     systolic blood pressure between 140-160 mm Hg.      Intervention: One group receives treatment with a breathing device (Resperate©) and the other     group receives treatment with a control breathing device. The latter device does not try to     alter the breathing pattern.      Main study parameters/endpoints: The effect of the breathing device on SBP is the main study     parameter. Secondary endpoints include diastolic blood pressure (DBP) and quality of life.   "
237085|NCT00951132|"     The purpose of this study is to investigate whether rosuvastatin decreases measures of     inflammation in depressive patients.   "
237086|NCT00951145|"     This is a retrospective/prospective study evaluating the clinical and radiographic outcome of     total hip arthroplasty (THA) performed using Accolade femoral stem in a consecutive group of     patients. All patients eligible for inclusion will be identified. The investigators     hypothesize that the outcome of THA performed using Accolade femoral stem is equal or     superior to historical survivorship of THA using other types of collarless, proximally     coated, tapered stems.   "
237087|NCT00951158|"     It has become apparent that many cancers depend on specific fats (lipids) for their continued     growth. Conjugated linoleic acid (CLA) is a safe, popular, and well-tolerated dietary     supplement that promotes weight loss and loss of fat. CLA was recently shown to block the     metabolism (uptake and production) of lipids required for growth of some cancers, resulting     in killing of cancer cells. The investigators will conduct a clinical trial to test whether     oral CLA blocks metabolism of lipids in patients with advanced cancers. Since the dose of CLA     that may do this is not yet known, the investigators will start at a dose of CLA known to be     tolerable and effective for weight loss. If this dose does not block lipid metabolism, the     investigators will test higher doses in successive groups of patients until the investigators     identify an effective dose, unless the investigators find that these higher doses cannot be     tolerated. In order to verify that CLA is absorbed, it is necessary to measure CLA levels in     blood before and after doses are given. Likewise, in order to verify that CLA blocks lipid     metabolism, the investigators will need to obtain small samples of abdominal fat (and, in     some patients, samples of tumors).   "
237090|NCT00951197|"     Capturing the earliest stages of Dementia especially Alzheimer's Disease (AD) is a great     challenge. Until now the NINCDS-ADRDA and the DSM criteria for AD were largely used as     diagnostic standards in research. However, the research on AD progresses and some biomarkers     have been recently suggested to improve the diagnostic criteria of AD, such as cerebrospinal     fluid markers, neuroimaging with Positon Emission Tomography (PET) or Magnetic Resonance     Imaging (MRI).   "
237091|NCT00951210|"     The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections     for the treatment of CLI patients.   "
237092|NCT00951223|"     This observational prospective registry is designed to evaluate the safety, adherence, and     efficacy of prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1)     and other prescribed therapies in patients chronically infected with HCV. The primary     endpoint for efficacy will be the SVR rate at 24 weeks after therapy ends.   "
237093|NCT00951236|"     Trigger finger, also known as stenosing tenosynovitis, is a painful condition that can cause     discomfort and disability. Many physicians choose to locally inject cortisone into the     infected finger although there is no current consensus as to how many injections are needed     to achieve maximum relief. This study will be a prospective, randomized study to compare one     versus two injections for the treatment of trigger finger.   "
237094|NCT00951249|"     It has been estimated that black men who have sex with men (MSM) account for one quarter of     all new HIV infections in the US annually, yet little prevention work has been directed     towards this population. The purpose of this study is to research and potentially design a     new and better way to try and slow the spread of HIV among black MSM.   "
237095|NCT00951262|"     This study aims to develop a life review program and test its effectiveness on a sample of     patients with advanced cancer patients receiving palliative care at home in Fuzhou.   "
237096|NCT00951275|"     This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying     Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe     active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs     will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6     months. The anticipated time on study treatment is 3-12 months, and the target sample size is     100-500 individuals.   "
237097|NCT00951288|"     This is a pilot interventional study whose aim is to determine the effect of a dietary     supplementation with a Crocus Sativus extract, Saffron, on macular cone-mediated function in     patients with early age-related macular degeneration (AMD). Pre-clinical evidence ( Maccarone     R, Di Marco S, Bisti S. Saffron supplement maintains morphology and function after exposure     to damaging light in mammalian retina. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):1254-61.)     indicates the potential effectiveness of Saffron as a retinal neuroprotectant in animal     models of retinal degenerative disorders.The macular function will be tested by visual acuity     and macular cone-mediated electroretinogram (focal electroretinogram, FERG) according to a     standardized technique (see citations).   "
237098|NCT00951301|"     This study is being done to see if the addition of mangosteen juice to standard medical care     will reduce the risk of atrial fibrillation (AF) recurrence following direct current (DC)     cardioversion. The study will also look at the effects the mangosteen juice may have on     biomarkers of inflammation and endothelial cell dysfunction (the tissue lining the arteries     does not function properly).   "
237099|NCT00951314|"     Objective:      Cocaine addiction continues to be an important public health problem with over 1.7 million     users in the US alone. Cocaine addiction is characterized by compulsive drug use despite     adverse consequences and high rates of relapse during periods of abstinence. Cocaine     addiction may be mediated by neuroadaptations in reward-related learning and memory processes     in the mesocorticolimbic dopamine system and glutamatergic corticolimbic circuitry.     Metabotropic glutamate subtype 5 receptors (mGluR5) likely play essential roles in mediating     some of the actions of drugs of abuse. Animal studies have shown that mGluR5 knock-out or     blockade reduces self-administration of cocaine and cocaine-induced hyper-locomotion.     However, to what extent mGluR5 are involved in the pathophysiology of cocaine addiction in     humans is currently unknown, partly due to the lack of suitable methods to reliably quantify     mGluR5 in the living human brain.      This protocol aims to determine whether the density of mGluR5 in brain is altered in     participants with cocaine addiction compared to healthy controls using positron emission     tomography (PET) and the recently developed radiotracer for mGluR5, [18F]SP203. We also aim     to determine whether this density is related to genotype, history of cocaine use, and/or     craving for cocaine.      Study Population:      The study populations will consist of healthy adults with no history of substance abuse and a     matched group of healthy current primary cocaine dependent male and female participants     (20-50 years old.; N=40/group).      Design:      Density of mGluR5 will be measured in cocaine dependent participants and healthy adults     volunteers with PET and (18F)SP203, a radioligand with specificity for mGluR5. All     participants will undergo genotyping to identify normal or variant mGluR5 gene associated     with drug abuse. The intensity of craving for cocaine will be assessed while watching a video     about cocaine use.      Outcome measures:      Density of mGluR5 will be compared between cocaine dependent participants and healthy     controls. In addition, correlation among the genetic polymorphism, the craving response, and     the density of mGluR5 will be determined.   "
237100|NCT00951327|"     Patients with primary sclerosing cholangitis (PSC) are affected by an inflammatory condition     of the bile ducts. Unfortunately, patients with PSC have a 10 to 15 percent lifetime risk of     developing gallbladder and bile duct cancers. Gallbladder and bile duct cancers have a     five-year survival of only 5 to 10 percent. Surgery to provide a cure must remove all cancer     confined to one area.      In order to increase survival rates there is a need to identify cancer and pre-cancer early.     This has been difficult to do.      Patients who have lab tests, positive imaging tests or obstructions will usually have a test     called ERCP (Endoscopic Retrograde Cholangiopancreatogram) to take biopsies and enlarge bile     ducts or opening bile ducts with stents. Patients usually have cells in the bile ducts     removed and analyzed, but there are not studies to show how sensitive this may be to     determine if the cells are cancer or pre-cancerous. A new scope with a system using light     filters called Narrow Band Imaging (NBI) may help detect cancer and pre-cancer more often and     at an earlier stage.   "
237101|NCT00951340|"     This study will test the feasibility and safety of adding interpersonal and emotional     processing techniques to standard cognitive behavioral therapy for generalized anxiety     disorder.   "
237125|NCT00951652|"     This study will test a version of cognitive behavioral therapy for generalized anxiety     disorders that incorporates interpersonal and emotional processing techniques.   "
237126|NCT00951665|"     This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to     evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine     (T-DM1) administered by intravenous (IV) infusion in combination with paclitaxel (and     pertuzumab, if applicable) in patients with human epidermal growth factor receptor 2-positive     (HER2-positive), locally advanced or metastatic breast cancer.   "
237102|NCT00951353|"     Transplantation is the preferred method of treatment for end-stage renal disease (ESRD) in     children. Over the past forty years, the use of newer immunosuppressive drugs has decreased     the risk for organ rejection considerably, and improved short-term outcomes. However, these     costly and complicated life-long treatment regimens also cause serious side effects. This has     been particularly true for children, who undergo treatment with these drugs at the same time     they are transitioning, physically and emotionally, from childhood to adulthood. These     factors lead to significantly reduced life-spans, decreased drug regimen adherence, and an     increased need for re-transplantation, as compared with adults.      Current immunosuppressive procedures and strategies for children mimic those for adults,     despite the difference between the two populations' immune systems and needs. New strategies     aimed at tailoring to an individual child's needs would both reduce the risk of complications     and improve outcomes. The purpose of this study is to generate information which will help to     change the current practice of pediatric transplantation into one that is more individualized     and preventative.   "
237103|NCT00951366|"     The goal of the Bronchopulmonary Dysplasia (BPD) Patient Registry is to collect data on     individuals with neonatal lung disease to better understand the illness and ultimately     improve their care and survival. The Patient Registry was established in 2008 as a means to     monitor important trends in the BPD population and to improve understanding, treatment, and     survival.   "
237104|NCT00951379|"     The goal of this clinical research study is to learn how Actos (pioglitazone) may affect oral     premalignant lesions (OPLs) and/or the risk of mouth cancer. The safety of this drug will     also be studied.   "
237105|NCT00951392|"     An increase of longevity and of the number of men and women older than 60 years old is     observed in most industrialized countries. Aging is a complex, multifactorial and continuous     process involving physical and biological modifications such as a notably decrease in glucose     tolerance and type 2 diabetes risk. Insulin sensitivity follow-up during aging is difficult     mainly because of many confounding factors (environment, lifestyle).      In 2006, SUVIMAX 2 study began, based on the monitoring of volunteers who participated in     former SUVIMAX study (1994-2003). This study was a randomised trial which was designed to     study the link between a low antioxidant intake and risk of cancer or ischemic heart disease.     The subjects recently had a health check-up including complete information about their diet,     physical and neurosensory status. Based on these data, a score was established to classify     subjects according to their quality of aging (successful aging versus problematic aging)     These volunteers, who undertook a 13-year follow-up (dietary and medical status), constitute     the reference population to determine the mechanisms involved in the insulin resistance     development in aging.      The purpose of our research work is to determine whether the quality of aging could influence     insulin sensitivity, by studying metabolic profile and change in gene expression (genes     involved in glucose metabolism and metabolic senescence in muscle tissue) during aging.   "
237106|NCT00951405|"     This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical     trial is to investigate the safety and the efficacy of a prophylactic treatment option with     long acting coagulation factor VII (LA-rFVIIa) for haemophilia patients with inhibitors.   "
237107|NCT00951418|"     This study aim to investigate the relationship between serum levels of clozapine and     cognitive performance in patients with ICD-10 Schizophrenia and treated with clozapine     monotherapy. The hypothesis is that higher serum levels of clozapine are associated with     cognitive dysfunctions. Furthermore, ECG changes and the relation to serum level of clozapine     are studied. The design is cross-sectional.   "
237108|NCT00951431|"     Functional dyspepsia is one of the most common digestive disorders. The pathophysiology of     functional dyspepsia is uncertain. Proton pump inhibitor (PPI) has been recommended as the     first line treatment for functional dyspepsia. However, the mechanism of symptom relief is     unclear. Most of the previous studies were performed on healthy volunteers who received only     a very short course of PPI. The correlation between symptom and gastric emptying is lacking     in these studies.      Demographic data and anthropometric measurements will be obtained for baseline assessment.     Patients are required to complete FGI Screening Questionnaire, Functional dyspepsia symptom     questionnaire, gastroesophageal reflux disease (GERD) symptom questionnaire and irritable     bowel syndrome (IBS) symptom questionnaire to have a thorough assessment of their GI     symptoms. (1) Satiety test and ghrelin profile, and (2)gastric emptying test will be arranged     as two individual visits.      After baseline investigations, patients will be randomly assigned to either Nexium 20 mg     daily or identical looking placebo for 8 weeks. The patients will report their individual     dyspeptic symptoms on weekly basis using a self-administered symptom questionnaire.      Satiety test and ghrelin profile, gastric emptying study will be repeated at the end of     8-week treatment.      Hypothesis: Long-term PPI relieves dyspeptic symptom through acceleration of gastric emptying     rate.   "
237109|NCT00951444|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as MK-0646, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known     whether gemcitabine hydrochloride and carboplatin are more effective when given together with     or without MK-0646 in treating patients with non-small cell lung cancer.      PURPOSE: This randomized phase II trial is studying how well gemcitabine hydrochloride and     carboplatin work when given together with or without MK-0646 as first-line therapy in     treating patients with stage IIIB or stage IV non-small cell lung cancer.   "
237110|NCT00951457|"     The primary objective of this study is to determine the percentage of patients achieving a     response, defined as the percentage of patients achieving complete response, partial response     and stable disease/ no change upon treatment with the combination therapy according to NCI     response criteria (also established according to IWCLL guidelines) upon treatment with a     combination of bendamustine and alemtuzumab.   "
237170|NCT00952237|"     We postulate that the combination of IL-2 and GM-CSF immunotherapy will efficiently mobilize     autologous peripheral blood stem cells and activated immune effector cells in patients with a     hematologic malignancy. These activated effector cells will improve the immune function of     the graft. These hypotheses will be tested using this proposed clinical trial to mobilize     autologous peripheral blood stem cells pre-transplantation.   "
237111|NCT00951470|"     Objectives:      Specific Aim 1: Estimate the prevalence of head and neck lymphedema in patients who have been     treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and     oropharyngeal cancer.      Compare functional outcomes in patients with and without lymphedema using cross-sectional     survey methods.      Specific Aim 2: Evaluate the effect of Complete Decongestive Therapy (CDT) provided in an     outpatient setting or a home-based program in reducing lymphedema in patients previously     treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and     oropharyngeal cancer at 1, 3 and 6 months follow-up. Patient characteristics, treatment     variables, and the health care environment will be analyzed as possible explanatory variables     that influence the effect of lymphedema treatment.      Specific Aim 3: Evaluate the effect of lymphedema treatment on symptom burden, self-image,     and functional performance status in patients previously treated with surgery and/or     radiation therapy (± chemotherapy) for oral cavity and oropharyngeal cancer.   "
237112|NCT00951483|"     No suitable treatment has been identified to reverse and ideally prevent, the cardiovascular     disease risk associated with depression and anxiety. The purpose of this study is to     determine if quetiapine treatment of depression can reverse the signs of arterial stiffening     that often occurs in depression and anxiety, and which are believed to be risk factors for     future heart disease.   "
237113|NCT00951496|"     This randomized phase III trial studies bevacizumab and intravenous (given into a vein)     chemotherapy to see how well they work compared with bevacizumab and intraperitoneal (given     into the abdominal cavity) chemotherapy in treating patients with stage II-III ovarian     epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal     antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread by     blocking the growth of new blood vessels necessary for tumor growth. Drugs used in     chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing. It     is not yet known whether giving bevacizumab together with intravenous chemotherapy is more     effective than giving bevacizumab together with intraperitoneal chemotherapy in treating     patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.   "
237114|NCT00951509|"     The purpose of this research study is to examine whether computer based or virtual reality     based driving assessments are as useful as real-world power wheelchair driving tests in     measuring driving performance and whether they may be useful in helping to identify the     problems that some individuals may have with driving power wheelchairs. The specific aims are     as follows:      Specific Aim 1: To develop computer-based and VR-based wheelchair driving assessments for     both drivers and non-drivers that correspond to an accepted real-world driving assessment     (Power Mobility Road Test) and compare them to the real-world assessment and to each other.      Specific Aim 2: To develop additional features of the computer-based and VR-based assessments     that present dynamic tasks and determine whether skills on these tasks can be delineated     within the virtual environment.   "
237115|NCT00951522|"     The purpose of this study is to evaluate the safety and tolerability of escalating doses of     GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore     airway hydration and mucociliary clearance in the lung.   "
237116|NCT00951535|"     This is a prospective, phase II non-randomised controlled clinical study. Dose escalation     will be implemented using 1.8 Gy increments from baseline 75.6 Gy. Patients' RT prescription     may be escalated up to max 81 Gy once dose volume constraints are adhered to.      All patients will be treated using the participating institution's standard rectal     preparation protocol, bladder-filling protocol and appropriate immobilisation device(s).      Cone beam CT on-treatment imaging is recommended for this study. However, the use of     individual institutional imaging equipment and techniques is permitted.      Acute GU/GI toxicities will be assessed weekly during treatment.      GU/GI toxicities will also be assessed 2 months post RT, 8 months post RT and 6 monthly     thereafter to year nine and in line with the participating institution's standard routine     follow-up (FU) thereafter.   "
237117|NCT00951548|"     This is a double-blind, randomized, placebo controlled study to assess the beneficial effects     of food supplementation with VSL#3 as a support to standard pharmaceutical therapy in     patients affected by mild to moderate active ulcerative colitis.   "
237118|NCT00951561|"     The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in     women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject     was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their     treatment for two intervals.   "
237119|NCT00951574|"     In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal     (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy     will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in     double-blind conditions to a treatment with subcutaneous low molecular weight heparin     (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy     or up to a maximum of 4 months (+/- 10 days).   "
237120|NCT00951587|"     The purpose of this study is to evaluate the effect of the night procedure in regards to     colon cleansing level and capsule excretion rate.   "
237121|NCT00951600|"     The study was conducted as an open label, balanced, randomized, two-treatment, two-period,     two-sequence, single- dose, crossover bioavailability study comparing oxcarbazepine 300     mg/5mL oral suspension of OHM Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc.)     with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of Novartis     Pharmaceutical Corporation in healthy, adult, male, human subjects under fasting conditions.   "
237122|NCT00951613|"     The purpose of this study is to determine whether NK012 is safe and effective in the     treatment of relapsed small cell lung cancer.   "
237123|NCT00951626|"     RATIONALE: Visiting patients at home to teach them about self care after a stem cell     transplant may be more effective than standard therapy in improving quality of life.      PURPOSE: This clinical trial is studying home visits to see how well they work compared with     standard therapy in treating patients undergoing donor stem cell transplant for hematologic     cancer.   "
237334|NCT00964444|"     This study is an observational study to prove that a new device, which measures the force of     delivering a baby, (US patent 6,684,165) functions as described in the patent. This is the     first time this has been used with patients.   "
237127|NCT00951678|"     Central venous catheterization is a common and important procedure done in the emergency     department. The internal jugular vein (IJV), subclavian vein (SV) and femoral vein (FV) are     commonly used for central venous access. Unfortunately, this procedure has high-risk     complications.      Traditionally, physicians have relied on the use of anatomic landmarks and physical     manipulation such as moving the head or rotating the leg in order to place central catheters;     however, studies have demonstrated that significant anatomic variations exist within large     percentages of study populations. In addition, although studies have demonstrated that the     use of ultrasonography for placement of femoral catheters leads to lower rates of     complications, no previous studies have specifically determined anatomic variations in the     femoral triangle. Therefore, this study will examine the anatomic variation of the IJV vs.     carotid artery and the femoral vein vs. femoral artery in the emergency room setting. The     investigators will study the variation as a function of sex, age, race, body habitus and     degree of head rotation (measured using a goniometer) and in doing so, the investigators will     demonstrate the utility of using ultrasound to place central lines in order to decrease     morbidity.   "
237128|NCT00951691|"     This study will develop and test a new program of enhanced medical rehabilitation for elderly     people who have had an acute disabling medical event and are admitted to a skilled nursing     facility for post-acute rehabilitation.   "
237129|NCT00951704|"     The prognosis of cardiac arrest patients is generally poor. Recent studies have showed that     the high quality of CPR increases the survival after cardiac arrest. Therefore the     investigators planned this prospective observational study to determine the epidemiology of     sudden cardiac arrest in the prehospital setting of Tampere area, the quality of the CPR, and     also the associations between depth and frequency of chest compressions and invasive arterial     pressure, EtCO2,cerebral oxygenation and iatrogenic injuries associated to chest compressions     1) in patients resuscitated out of hospital by emergency medical service's (EMS's) personals     and 2) in-hospital by hospital resuscitation team members. In addition, the investigators     will analyze the effects of the chosen method of resuscitation on critical vital signs (Etco2     and invasive pressures): closed-chest CPR is compared to open-chest CPR, or mechanical CPR     with a device (AutoPulse-CPR, Cardio Pump) compared to manual CPR guided with quality CPR     device. The results will give the investigators important insights into the haemodynamics of     CPR which may guide future strategies for the management of cardiac arrest. The research     group is also interested in CPR related injuries and mattress effect. Quality of life after     CA is evaluated among survivals and the cause of death among non-survivors.   "
237130|NCT00951717|"     This study will test an intervention that aims to prevent postpartum depression by providing     new mothers with information on and resources for dealing with the disorder.   "
237131|NCT00951730|"     People with Down syndrome are at increased risk of sleep apnea, not only from obstruction of     the upper airway, but also of central origin. According to published data, sleep apnea may     occur in at least 40% of children and adults with Down syndrome. Consequences of these sleep     apnea are numerous : failure to thrive, cognitive decline, high blood pressure, heart     disease, accident due to day sleepiness, fatigue. This condition is treatable in people with     Down syndrome, as it is in ordinary people.      Diagnosis of sleep apnea in people with Down syndrome is therefore a major concern. In     addition, data regarding age of apparition of this complication are missing, making repeated     screening necessary.      Polysomnography is the method of choice for the diagnosis of sleep apnea. Unfortunately, it     is time consuming and sleep departments are heavily busy.   "
237132|NCT00951743|"     This is a 24 week placebo controlled, double-blind, 2-arm study of ADAPTAVIR, Monomeric     Dala1-peptide T-amide (mDAPTA) compared to placebo, in HIV infected individuals with     suppressed plasma viral loads < 200 copies/ml by highly active antiretroviral therapy (HAART)     treatment for at least 3 months prior to entry with at least 6 continuous months of HAART     treatment preceding entry. 20 treatment and 20 placebo individuals will be enrolled in each     arm. The study duration is 24 weeks on placebo or mDAPTA administered intranasally at 0.01 mg     two times a day.      The main (intent to treat) analysis is planned for the 24 week endpoint. The virological     outcomes of interest in the present study are infectious virus recoverable from cellular     (PBMC) sources and cellular viral mRNA and DNA copy numbers. Immune outcomes (plasma     cytokines) associated with HIV disease, HIV replication, or immune function will be studied.   "
237133|NCT00951756|"     The purpose of this study is to determine the effect of dietary fat, in standard formulation,     on the composition of the human microbiome in a prospective study of normal volunteers.     Participants will be randomly assigned to either a high fat or low fat diet for 10 days. The     gut microbiome will be phylotyped in fecal samples as well as in bacteria adherent to the     colonic mucosa prior to, and during the course of the dietary interventions.   "
237134|NCT00951769|"     This is a non-human study, conducted in a simulation environment, with simulator manikins,     and volunteers from anaesthesia. Trainees in their first 2 years of anaesthetics training     will be randomised to a control group, a group following the Difficult Airway Society UK's     Guidelines and the Australian Difficult Airway management algorithm. A simulated difficult     airway will be created during the induction of anaesthesia. The investigators will examine     adherence to guidelines, which would have been provided to participants before the     experiment, as well as compare their performance with the guidelines.   "
237145|NCT00951912|"     Many studies showed that soy foods or soy isoflavones can lower the risk of cardiovascular     disease (CVD), osteoporosis and some cancers, but few human studies assessed effects of     purified isoflavone components (genistein and daidzein) on glucose metabolism. This     double-blinded, randomized, placebo-controlled trial will examine the effects of purified     genistein and daidzein on glucose metabolism in prediabetic or diabetic women. One hundred     and eighty eligible women age 30-70 years(without any treatment of diabetic drugs) will be     recruited and randomly allocated into the following three arms: Placebo (10g isolated soy     protein, ISP); Genistein (10g ISP + 50mg genistein); Daidzein (10g ISP + 50mg daidzein) per     day for 6 mo. Fasting glucose, lipids, insulin, inflammation marks and post-load for glucose     and insulin will be determined at 0, 3th, and 6th month. Changes in these indices will be     compared among the three groups.   "
237335|NCT00964457|"     response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced     rectum cancer   "
237135|NCT00951782|"     Deep transcranial magnetic stimulation (TMS) is currently being evaluated as a treatment     option in major depression. It has been shown to be a safe procedure . Deep transcranial     magnetic stimulation coils are designed to maximize the electrical field deep in the brain by     the summation of separate fields projected into the skull from several points around its     periphery. The device is planned to minimize the accumulation of electrical charge on the     surface of the brain. Such accumulation can give rise to an electrostatic field that might     reduce the magnitude of the induced electric field both at the surface and inside, thus     reducing the depth penetration of the induced electric field . Deep transcranial magnetic     stimulation could be more effective than repetitive transcranial magnetic stimulation due to     its deeper penetration into brain tissues . The deeper penetration should produce greater     action on nerve fibers connecting the prefrontal cortex to the limbic system.      The ability of high-frequency repetitive transcranial magnetic stimulation (rTMS) to alter     dopaminergic neurotransmission in subcortical structures could explain recent reports, which     suggest that it has the potential to reduce smoking and nicotine craving. Ecihhammer et al     demonstrated a reduction in the number of cigarettes smoked and in the desire to smoke after     a single rTMS treatment (Eichhammer et al., 2003). In addition, Johan et al in a cross-over,     double-blind, placebo-controlled study demonstrated a reduction in cigarette consumption and     desire to smoke after a single repetitive transcranial magnetic stimulation treatment (Johann     et al., 2003). Recently, the investigators have finished a complete study on nicotine     addiction using repetitive transcranial magnetic stimulation for 10 consecutive days. They     have found that 10 days of rTMS reduced significantly better from placebo the number of     cigarettes smoked, nicotine dependence and craving (Amiaz et al 2007, in preparation).     Interestingly, some of the effects were stronger in the sub-group of patients that were     presented with smoking-related pictures immediately prior to stimulation onset. Although,     these results are interesting and exciting, they have two important caveats. First, only     about 50%-60% of the smokers responded to the repetitive transcranial magnetic stimulation     treatment. Second, among those responded to the treatment, only 10% had quit totally from     smoking. Therefore, the potential therapeutic benefit of this treatment is limited. The     investigators' hypothesis is that deep transcranial magnetic stimulation may be more     efficient in smoking cessation due to it's deeper penetration and therefore it's capability     to stimulate deeper fibers of the dopamine-reward-activating system.   "
237136|NCT00951795|"     This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate     CD4+ T-cells in whole blood over the measurement range expected for the intended population.     The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and     determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.   "
237137|NCT00951808|"     Acute chest syndrome (ACS) is similar to severe pneumonia and is a common cause of     hospitalizations for people with sickle cell disease (SCD). Blood transfusions are one     treatment option for ACS. High levels of an enzyme called secretory phospholipase A2 (sPLA2)     may be present in people before they develop ACS. This study will determine how well sPLA2     levels can predict the onset of ACS and whether identifying high sPLA2 levels allows enough     time to prevent ACS with blood transfusions. Results from this study will help to determine     the feasibility of conducting a larger study that would further examine the use of sPLA2     levels and blood transfusions to prevent ACS in people with SCD.   "
237138|NCT00951821|"     This study will develop an integrated treatment for adolescents who are depressed and     suicidal and their parents who are depressed and have a history of suicidality.   "
237139|NCT00951834|"     EGCG has shown a neuroprotective effect in cell-experimental and animal studies. The     neuroprotective mechanism of EGCG probably bases - besides the known antioxidant effect -     amongst others on the modulation of several signal transduction pathways, the influence on     the expression of genes which regulate cell survival resp. programmed cell death, as well as     the modulation of the mitochondrial function. In different Alzheimer models EGCG seems to     cause an induction of alpha-secretase and the endothelin-converting-enzyme, as well as to     prevent the aggregation of beta-amyloid to toxic oligomers through the direct binding to the     unfolded peptide.      The investigators therefore expect EGCG to have a positive influence on the course of the     Alzheimer´s Disease.   "
237140|NCT00951847|"     The purpose of this study is to compare the single-dose oral bioavailability of oxcarbazepine     300 mg/5mL oral suspension of OHM Laboratories, USA (a subsidiary of Ranbaxy Pharmaceuticals     Inc.) with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of     Novartis Pharmaceutical Corporation, USA in healthy, adult, male, human subjects under fed     conditions.   "
237141|NCT00951860|"     The heart rate variability assessment of the sympathetic-parasympathetic balance is a strong     analytical tool in the autonomic nervous system (ANS) physiology, at each end of life.      In neonatology, it represents an important marker for understanding the breath and cardiac     dysfunction, incriminated in the pathophysiology of unexplained death syndrome and     apnea-bradycardia of prematurity.      If recent clinical studies conducted by our team highlight a close link between the     maturation degree of the ANS and gestational or postnatal age, with a substantial autonomic     dysfunction in preterm infants, no study to date has focused profile autonomic maturation in     the first two years of life, as that period for the infant is a vulnerability window     especially cardiopulmonary and neurological.      Psychomotor prognosis of newborns is more serious if prematurity is important and if     periventricular leukomalacia or cortical anatomical brain lesions are obvious. However, the     conventional imaging (Trans fontanel ultrasound, CT, MRI) is not sufficient in the neonatal     period to thoroughly evaluate the neurological risk situations. During the neonatal period,     the assessment of autonomic control, in practice easily quantifiable from time and     frequency-domain analysis of cardiac RR variability, could be a strong marker, at a given     time, from a neurological disorder undetectable by imaging, including sympathetic and     parasympathetic nerve conduction dysfunction in some brainstem nuclei and cortical areas.      The postnatal profile of the autonomic balance, as a marker of well ANS regulation could     become an additional support to correlate transient or permanent autonomic deficit with a     psychomotor development disorder at 2 years of age or later. This tool could be a help to     target the children with a neurological risk and to schedule early therapeutic interventions     and psychological or educational support.   "
237142|NCT00951873|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     safety, local tolerability and pharmacokinetic profile (the determination of the     concentration of the administered medication in blood over time) of long acting activated     recombinant human factor VII when injected subcutaneously (under the skin).   "
237143|NCT00951886|"     Rationale: Forced spirometry maneuvers are not routinely performed in patients with Ataxia     Telangiectasia (A-T), even though they suffer from respiratory illnesses.      Objectives: To study the feasibility and validity of forced spirometry in A-T patients.      Methods: Patients will perform spirometry during clinical visits. Parameters studied will be     technical quality, relation to predicted values, age, pulmonary illness, body mass index,     mutational status and mutation.   "
237144|NCT00951899|"     The goal of this study was to determine the metabolic mechanism for a certain type     medication's ability to lower blood sugar after a meal in Type 2 Diabetics, in order to     develop a better understanding of it's potential role in the treatment of obesity.   "
237146|NCT00951925|"     Potential donors who are undergoing bone marrow biopsy or bone marrow donation as part of     clinical care will be asked by the principal investigator (PI) if they might be interested in     donating marrow for this research project. If they are interested, the PI will meet with the     prospective donor to review the information contained in the informed consent document and to     answer any questions the potential subject may have. Bone marrow aspirates of approximately     5cc will be obtained from the posterior iliac crest of subjects using standard techniques.   "
237147|NCT00951938|"     The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody     spacer and supplemental anterior fixation of the surgeon's choice and to follow the patients     to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that     Trinity Evolution combined with an interbody spacer and supplemental anterior fixation will     result in fusion rates and clinical outcomes similar to those with other routinely used     autograft and allograft materials including: fusion, improvement in pain and function,     maintenance of upper extremity neurological function, and absence of serious adverse events     related to the use of the Trinity Evolution product.   "
237148|NCT00951951|"     The primary objectives of the study is to compare gait kinematics and the return to     normalization of gait in patients that have undergone a Total Hip Arthroplasty (THA) via the     direct anterior approach versus the posterior approach. Gait kinematics will be measured     using the IDEEA LifeGait device from Minisun (Fresno, CA).   "
237149|NCT00951964|"     Dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of     cutaneous bullous lesion arising spontaneously or after mechanical trauma.      These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no     treatment available. Cares are consisting to dress lesions and to protect the skin.      The investigators have recently observed on patients having residual expression of collagen     VII that phenotype severity is modulated by activation degree of dermic metalloproteinase.     The investigators have also observed that epigallocatechin-3-gallate (Polyphenon E®) could be     regulated this activity.      The primary purpose of this study is to assessing the efficacity of Polyphenon E to decrease     the number of cutaneous bullosa after four month of treatment.      The primary outcome measure is the rate of patient presenting a decrease of 20% or more of     the number of cutaneous bullosa.      Secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the     average duration of cicatrisation and treatment tolerance.      This study foresees the inclusion of 22 patients older than 2 years old in 5 centers.      When patients are included, they will be randomized and receive the treatment (or placebo)     for 4 months.   "
237150|NCT00951977|"     Kidney transplantation from living donors has been shown to carry many benefits over deceased     donor transplantation. Because of benefits such as shorter waiting times and improved outcome     for transplant recipients, living kidney donation accounts for an increasing number of kidney     transplants nationwide. Most published studies about living kidney donation demonstrate that     the procedure is safe, but they also emphasize concerns that long-term data on live donor     outcomes are insufficient. The purpose of this study is to assess the long term outcomes and     risks that may arise from living kidney donation.   "
237151|NCT00951990|"     Despite the widespread use of hip and knee replacement surgery, there is a considerable lack     of consensus regarding postoperative treatment and rehabilitation, mostly because of the lack     of well-designed studies testing the efficacy and effectiveness of such practices.      In particular there are no recommendations regarding the use of ergometer cycling after hip     or knee replacement surgery.      Therefore the investigators initiated a multicenter controlled clinical trial evaluating the     effect of ergometer cycling versus no ergometer cycling after hip or knee replacement     surgery.   "
237152|NCT00952003|"     The primary objective of this study is to determine the efficacy of an Oxaliplatin /     Irinotecan / Bevacizumab therapy followed by Docetaxel / Bevacizumab therapy followed by     Bevacizumab until progression in the treatment of locally advanced metastatic gastric cancer,     in terms of response rates (complete or partial response, determined by radiologic evaluation     according to Response Evaluation Criteria in Solid Tumors (RECIST)).      Secondary objectives Secondary Objective: To determine the safety profile of a an     Oxaliplatin/Irinotecan/Bevacizumab therapy followed by Docetaxel/Bevacizumab therapy followed     by Bevacizumab until progression in terms of qualitative and quantitative toxicities from     first study treatment dose until completion of study treatment due to progression or for any     other reason.      Secondary Objective: To evaluate the study population with respect to the following: overall     survival (from treatment start until death from any cause) and progression free survival     (from treatment start until progression or death from any cause).   "
237153|NCT00952016|"     To assess the efficacy of methotrexate in a genetically selected population of patients with     advanced colorectal cancer, who have loss of a particular gene, MSH2. The efficacy of     methotrexate will be evaluated by the proportion of cases that have a significant response to     treatment (objective response rate).   "
237154|NCT00952029|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium,     and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Bevacizumab may stop the growth of colorectal     cancer by blocking blood flow to the tumor. It is not yet known whether giving more than one     drug (combination chemotherapy) is more effective when given with or without bevacizumab in     treating patients with metastatic colorectal cancer.      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with or     without bevacizumab to see how well it works in treating patients with metastatic colorectal     cancer.   "
237155|NCT00952042|"     The use of eccentric resistance training as management of Achilles tendinopathy is     widespread. The investigators have recently demonstrated that heavy slow resistance training     was superior in the management of patellar tendinopathy.      Hypothesis: heavy slow resistance training is more effective than eccentric resistance     training in the clinical management of Achilles tendinopathy.   "
237156|NCT00952055|"     This is a prospective observational study focused on monitoring the effects of various     treatment options for acute coronary syndrome (ACS) patients by measuring serum neopterin     levels. Serum neopterin is a marker for measuring macrophage activation. Prior studies have     illustrated that there are elevated serum neopterin levels in ACS. Patients enrolled are     those with ACS. Blood samples are drawn at presentation, and at 72 hours after admission, or     at office visits and at 72 hours later. Neopterin levels are measured via a commercially     available assay..   "
237157|NCT00952068|"     The primary objective of this study is to determine the time of onset of analgesic effect of     Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include     determining the relationship between analgesic effect and plasma levels for Tramadol     Contramid® OAD and to examine safety after single dose administration of 200 mg of Tramadol     Contramid® OAD.   "
237158|NCT00952081|"     This protocol describes a study to gain experience in the use of Clevidipine for     perioperative blood pressure control in patients undergoing craniotomy for brain tumor or     epilepsy focus resection. The purpose of this study is to establish the efficacy of     Clevidipine for intraoperative blood pressure control in patients undergoing intracranial     procedures, and gather information on the dosage and adverse effects of Clevidipine in     neurosurgical patients. This initial pilot experience serves to familiarize the investigators     with the use of this drug prior to initiating a planned randomized trial versus institutional     standard-of-care therapy. The investigators will obtain greater familiarity with the dosing     of clevidipine in this patient population and collect information on the incidence of adverse     effects.   "
237159|NCT00952094|"     Randomized, open, single ascending dose, parallel study to evaluate the pharmacokinetics,     pharmacodynamics and safety of KRN1493 after single oral administration in healthy Korean     male volunteers.   "
237160|NCT00952107|"     The main purpose of this study is to test the ergonomics of an investigational imaging system     that can take pictures of blood vessels under the skin. In plastic and reconstructive     surgery, blood flow to tissue determines whether the tissue can be transplanted from one     location to another. This new imaging device uses invisible near-infrared fluorescent light     to see blood vessels that otherwise could not be seen by eye. This study will test the     system's basic operation and ergonomics in the operating room.   "
237161|NCT00952120|"     The purpose of this study is to compare how well two methods (VAC and G-SUC) of securing skin     grafts using negative pressure wound therapy work. Negative pressure wound therapy is a     commonly used method of applying suction on wounds to remove fluid from wound and to promote     healing. The VAC system is widely used and consists of a foam dressing and a portable     computerized suction pump. The G-SUC method uses commonly available dressing supplies     attached to vacuum (suction) pump located on the wall above a hospital bed. The investigators     have frequently used both methods over the past 10 years and have not observed any specific     negative side effects of either.   "
237162|NCT00952133|"     The purpose of this study is to determine if subjects who receive Palonosetron plus     Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive     Palonosetron alone.   "
237163|NCT00952146|"     This study is a feasibility study. Patients with acute abdominal pain who are planning to     undergo a diagnostic laparoscopy are asked to participate in the study. The aim of the study     is to evaluate if transgastric peritoneoscopy is feasible.   "
237164|NCT00952159|"     Many methods to detect CYP2D6 poor metabolizers have been validated. Some of them are based     on phenotyping (metabolism of dextromethorphan or debrisoquine) and some others on     genotyping. Up to now, CYP2D6 pharmacogenetics has been restricted to the field of research,     in spite of poor metabolizer profile concerns 5 to 10 % of caucasian population.     Nevertheless, the polymorphism of CYP2D6 is responsible for the metabolism of many drugs,     particularly of two opioids involved in pain management: codeine and tramadol, their     metabolites representing the most effective part of the drug effect. So prescribing codeine     or tramadol in a patient poor metabolizer for the CYP2D6 is likely to be ineffective in pain     management.      O-demethyl-tramadol, the metabolite of tramadol via CYP2D6, is important to consider because     its analgesic effect is 2 to 4 times more potent than tramadol.      The investigators propose to phenotype CYP2D6 in post-operative patients treated by tramadol     by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in     comparison with genotype, and to find a threshold to determine poor metabolizers. As already     described, genotyping CYP2D6 will use a rapid detection method of the alleles implicated in     poor metabolizer status (CYP2D6*3, *4, *5 et *6) in a Caucasian population. Sampling will be     executed at two times (H24 and H48 after surgery) and only with blood (three EDTA tubes)     during the post-operative monitoring of the patients. This study is likely to include 320     post-operative patients treated with intravenous tramadol during one year in three university     hospitals centers (CHU of Caen, Creteil and Rouen).      The first aim of this study is the validation of monitoring seric concentrations of     O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor     metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a     poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding     tramadol and codeine. The final objective of this research is to be able to determine the     CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take     of blood and a rapid response, this method should be liked to improve pain management.     Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs     depend on this way of metabolism.   "
237165|NCT00952172|"     This 3-year prospective, randomized, control, longitudinal study is aimed to (1) examine the     effect of stair stepping exercise training on cardiopulmonary fitness and sleep situation in     patients with Obstructive Sleep Apnea Syndrome (OSAS), and (2) follow the longitudinal change     after stair stepping exercise training in patients with OSAS. Patients meet the following     criteria will be invited to participate in this study: being diagnosed with AHI     (Apnea-hypopnea index)＞15/hr and ODI (oxygen desaturation index)＞10/hr by Polysomnography,     aged 19 or older. Based on the power analysis, 70 patients with OSAS treated in the     outpatient department of Chang Gung Medical Center will be recruited over a period of 26     months. Each patient will participate in this study for seventeen weeks. Patients will be     randomly assigned to receive stair stepping exercise in addition to nursing education and     standard care, or nursing education and standard care alone. Stair stepping exercise will be     performed at home daily for eight weeks. Outcomes will be determined by changes in the scores     of cardiopulmonary fitness index, VO2max, six-minute walking distance, daytime sleepiness     measured by Epworth Sleepiness Scale, sleep time measured by Actigraphy, and AHI measured by     Polysomnography; those taken four times: before treatment (baseline), five weeks, nine weeks,     and seventeen weeks of the study. Data will be analyzed using descriptive statistics and     Generalized Estimating Equation (GEE).   "
237166|NCT00952185|"     RATIONALE: The influenza vaccine may help prevent flu in patients who have undergone stem     cell transplant.      PURPOSE: This clinical trial is studying how well the influenza vaccine works in preventing     flu in patients who have undergone stem cell transplant and in healthy volunteers.   "
237167|NCT00952198|"     This is a Phase 1 study, involving a 10-day dosing period, designed to test the safety of     investigational study drug ARRY-403 (as monotherapy or in addition to stable metformin     therapy) in patients with Type 2 diabetes. Approximately 128 patients from the US will be     enrolled in this study.   "
237168|NCT00952211|"     There are two purposes of this study. The first purpose is to define the frequency of     obstructive sleep apnea in stroke survivors as well as its association with fatigue and     quality of life. The second purpose is to determine if continuous positive airways pressure     (CPAP) treatment can have a beneficial effect on these patients' fatigue and quality of life.   "
237169|NCT00952224|"     In acute myocardial infarction cardiovascular magnetic resonance imaging can retrospectively     detect the myocardium at risk and the irreversible injury. This allows for quantifying the     extent of salvaged myocardium after reperfusion as a potential strong end point for clinical     trials and outcome. The aim of the present study is to determine the prognostic significance     and determinants of myocardial salvage assessed by CMR in reperfused ST-elevation myocardial     infarction (STEMI).   "
237171|NCT00952250|"     This project is designed to examine the impact of tailored feedback on site performance.      The investigators' objective is to evaluate whether a 'personalized and targeted' feedback,     education and performance improvement intervention has a greater impact on adherence to     recommended guidelines than standard feedback.      The investigators hypothesize that a site-specific report with centrally identified targets     for improvement paired with target specific interventions will enable sites to quickly     identify and prioritize salient problem areas, have ready access to an analysis of factors     that underlie problems, and formulate an effective action plan. The investigators also     hypothesize that those hospitals randomized to receive intervention will be more likely to     improve their overall performance, as well as their target specific performance, during the     period of observation in direct response to activated QI processes.      Outcomes:      The primary outcome is improvement in the overall composite of all metrics eligible for     intervention regardless of their selection as targets.      The secondary outcome is improvement in the composite of targeted metrics.      Outcomes will be assessed in all participating sites, and in among relevant performance     subgroups (low performers, academic centers, full service, and among medication versus     process metrics).   "
237172|NCT00952263|"     This is a phase I, open-label, dose escalation study to evaluate the safety of MBL-HCV1 in     healthy adult volunteers. Eligible volunteers will be admitted to a phase 1 unit for study     infusion. A single dose of human monoclonal antibody will be administered. The study duration     is 56 days. During this time, safety will be assessed via physical examinations, laboratory     testing, concomitant medication usage and review of treatment emergent adverse events should     they occur. Pharmacokinetics will be derived from analysis of blood samples obtained during     the 56 day study.   "
237173|NCT00952276|"     The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic     vaccine in adults and the elderly.      Primary Objectives:        -  To describe the immunogenicity of the candidate vaccines after a single injection.        -  To describe the safety of the candidate vaccines after a single injection.   "
237174|NCT00952289|"     This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib     (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis     (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or     Post-Essential Thrombocythemia Myelofibrosis (PET-MF).   "
237175|NCT00952302|"     The study hypothesis is that body iron levels are important in determining the increase in     lung blood pressure that occurs in response to low oxygen levels. The purpose of this study     is to determine whether this is true at high altitude, where oxygen levels are low.   "
237176|NCT00952315|"     The investigators plan to compare three different devices that are used to break up large     kidney stones during surgery for removal to see if one is faster or more efficient than the     others.   "
237177|NCT00952328|"     The aim of this study is to conduct a pilot randomized controlled trial of the effect of     early limited formula supplementation on breastfeeding-related outcomes for infants with high     early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at     24-48 hours of age and will randomly assign them to early limited formula supplementation     following nursing (intervention group) or to no formula feeding (control group). Both groups     will receive intensive lactation support. Outcome variables will include breastfeeding status     on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and     exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that     early limited formula supplementation might help infants with early weight loss avoid     eventual weight loss ≥ 10% and associated breastfeeding problems.   "
237178|NCT00952341|"     This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment     of chemotherapy-induced nausea and vomiting in Chinese patients.   "
237179|NCT00952354|"     The objective of this research is to verify the language of children with Down syndrome     concerning lexical, syntactic and semantic aspects using MLU. The hypothesis is that children     with Down syndrome will present low performance, regarding not only the quantitative measures     as MLU-m, MLU-w, GM-1 and GM-2, but also regarding the qualitative aspects of their     production, when compared to children with typical development.   "
237180|NCT00952367|"     This study is to observe the carriage rate of Streptococcus pneumoniae (S.p.), Haemophilus     influenzae Type B (Hib) and Moraxella catarrhalis (M.Cat.) in healthy Chinese children aged     12-18 months in order to estimate the prevalence of pathogens that commonly cause infection     in Chinese young children. The antibiotic resistance of all isolates and the serotypes     distribution of S.p. isolates will also be tested. Potential risk factors for nasopharyngeal     carriage will be collected.   "
237181|NCT00958555|"     1. To establish a retrospective compilation of clinical, histopathological, treatment and          follow-up (clinic pathological) data of previous non-small cell lung cancer (NSCLC)          cases.        2. To establish a prospective collection of clinic pathological information from NSCLC          patients with corresponding blood and tissue samples        3. To discover and validate molecular biomarkers of survival and treatment outcome in NSCLC      One of the current difficulties in the management of lung cancer is the decision to treat and     the type of treatment to select. Thus there is a need for additional prognostic (indicative     of disease aggressiveness) and predictive (indicative of likely response to treatment)     markers for lung cancer. To conduct a successful prognostic and predictive marker program,     several factors are required, including: a comprehensive database linking clinical,     histopathological, treatment and outcome characteristics of each case, a collection of     samples linked to the database that is suitable for the testing of candidate markers, and a     multi-disciplinary, interdepartmental level of expertise in the management of lung cancer.      Objective 1:      A review of the case records will be conducted to extract clinical, treatment and follow-up     data      Objective 2:      Patients aged 21 years or more with newly diagnosed, untreated non-small cell lung cancer     shall be approached for consent. Patients will be identified through the pathology records,     and from the study investigators' clinic. After subject consent, baseline characteristics     will be obtained. Follow up data on therapies received and toxicities encountered will be     obtained. Tumor samples will be obtained only from patients with NSCLC undergoing surgery as     part of routine clinical care. The surgical specimen will be sent to Pathology to verify the     adequacy of the diagnostic sample as per usual practice. Blood will be collected at the     baseline (or prior to any anti-cancer treatment) and will be sampled again at the time of     relapse or disease progression. Collection will entail drawing 7ml blood into a Vacutainer     CPT tube (Becton Dickinson, USA), centrifugation, extraction of a separated layer of     mononuclear cells (MNC), labeling followed by storage below -80oC. The frequency of blood     drawn will be about 1-5 times (7-35mls total). The number of times depends on whether the     lung cancer relapses and in the advanced stage, how often the lung cancer relapses after     treatment. DNA and RNA will be extracted by CSIS and stored in freezer space there. Stored     samples will be used for investigation of prognostic and predictive markers of outcome and     for discovery of novel molecular alterations      Objective 3:      Biomarker analysis of tumor and blood. Blood will be enriched for circulating tumor cells     (CTC) using previously optimized methods (11) and DNA will be extracted from CTC and tumor     using the Tri-Reagent (Molecular Research Center, Cincinatti, OH). DNA will be extracted from     tumor, CTC and mononucleated cells and tested for somatic lung mutations by sequencing (2).     Germline DNA will be analysed for genes linked to genetic risk for NSCLC and, for treatment     toxicities, for genes related to NSCLC chemotherapy metabolic pathways.      Tissue microarray (TMA) is a high-throughput method of analysing large numbers of     formalin-fixed, paraffin-embedded tumor at a minimal cost and effort. To analyse the     expression of proteins of putative relevance to EGFR function, cell proliferation,     angiogenesis, apoptosis, metastasis, and hormonal, TMA will be utilised. PTEN and C/EBPa will     also be analysed.   "
237182|NCT00958568|"     The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC)     if used for a long time (47 weeks) makes patients suffering from Treatment Resistant     Depression stable, determine if OFC is safe when used to treat patients with Treatment     Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and     fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression     when treated for a long time (up to 47 weeks) and to assess the quality of life during     treatment.   "
237183|NCT00958581|"     Tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been reported to reduce blood     loss in the cardiac surgery literature but they have not been reported in use head-to-head in     the orthopedic surgery literature. In a randomized, double-blind, prospective study we     believe that TXA will be more effective than both EACA and placebo at reducing blood loss for     corrective spinal surgery.   "
237184|NCT00958607|"     About 50% of stroke survivors have limitations in their activities of daily living on return     to the community. Family caregivers provide invaluable support to these individuals during     their recovery and rehabilitation. Unfortunately, there is no standard clinical practice to     prepare caregivers for this role and, as a result, many experience stress and poor health     that can compromise stroke survivor recovery and threaten the sustainability of the care     needed to thrive in their home. To address this gap, the investigators have developed the     Timing it Right Stroke Family Support Program that aims to meet the evolving needs of     caregivers. The objective of this multi-province randomized controlled trial is to determine     if this program delivered across the stroke care continuum improves caregivers' sense of     being supported and emotional well-being. Ultimately this program could be used by stroke     care programs from across Canada.   "
237185|NCT00958620|"     Chronic Achilles tendinopathy is a painful condition with frequently unsatisfactory results     of conservative treatment. Extracorporal Shock Wave Therapy (ESWT) has been introduced in the     management of various soft tissue conditions. The objective of the study was to investigate     the effect of supplementary ESWT versus placebo to conservative treatment of chronic Achilles     tendinopathy.   "
237186|NCT00958633|"     Patients with bipolar I disorder (BD) experience depression 3 times more frequently than     mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of     patients. However, no placebo-controlled trials have assessed the efficacy or safety of     modern antidepressants in combination with mood stabilizers in the maintenance treatment of     BD. The investigators propose a multicentre, randomized, double-blind clinical trial     comparing mood stabilizer plus antidepressant (escitalopram or bupropion XL) to mood     stabilizer plus placebo in the maintenance treatment of BD.      The investigators hypothesize that in clinically representative patients with bipolar     disorder, who respond to acute treatment with a newer antidepressant medication in     conjunction with a mood stabilizing medication, continuing the antidepressant for 12 months     will reduce the risk of relapse into any mood episode, including depression, mania, and     hypomania, compared to stopping the antidepressant after 8 weeks.   "
237187|NCT00958646|"     The purpose of this study is to identify non-invasive biomarkers of the physiologic response     to Osteopathic Manipulative Treatment (OMT).   "
237188|NCT00958659|"     This research trial studies specimens from young patients with neuroblastoma. Studying the     genes expressed in specimens from patients with cancer may help doctors identify biomarkers     related to cancer. It may also help doctors predict how patients will respond to treatment.   "
237189|NCT00958672|"     The aim of this prospective study is to determine prevalence and characteristics of small     intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule     endoscopy. The investigators' findings may improve management of small intestinal involvement     in patients with systemic sclerosis.   "
237190|NCT00958685|"     An enteral diet supplemented with ginger extract in acute respiratory distress syndrome     (ARDS) patients may be beneficial for gas exchange and could decrease duration of mechanical     ventilation and length of stay in intensive care unit (ICU).   "
237191|NCT00958698|"     This randomized clinical trial is studying two different symptom management programs to see     how well they work compared with usual care in patients with recurrent or persistent ovarian     cancer, fallopian tube cancer, or primary peritoneal cancer. Developing a symptom management     plan may help relieve symptoms related to cancer or cancer treatment and help improve quality     of life.   "
237192|NCT00958711|"     The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and     compare its performance with the standard of care, saline moistened gauze, for the treatment     of diabetic foot ulcers.   "
237193|NCT00958724|"     The purposes of this study are to evaluate the safety and tolerability of neratinib in     combination with vinorelbine at the maximum tolerated dose (MTD) determined in a previous     study, or to determine a lower MTD of the two drugs, as well as to obtain preliminary     information on whether the combination of the two drugs has any effect on solid tumors in     Japanese patients.   "
237194|NCT00958737|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. It is not yet known whether giving more than one     drug (combination chemotherapy) is more effective when given for 3 months or 6 months in     treating patients with colon cancer.      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy for 3     months to see how well it works compared with giving combination chemotherapy for 6 months in     treating patients with stage III colon cancer.   "
237195|NCT00958750|"     The purpose of this study is to determine in women the risk/benefit profile and     non-inferiority of a topical 5% Minoxidil foam formulation applied once daily for the     treatment of androgenetic alopecia in comparison to 2% MTS used twice daily, using objective     and subjective efficacy measures and safety assessments for a study period of 24 weeks.   "
237196|NCT00958763|"     The Alcohol Use Reduction in Methadone Individuals with HCV was designed to compare three     different types of programs for methadone maintained men and women to determine which of the     three programs is most effective for:1) reducing alcohol consumption; 2) improving knowledge     of and attitudes toward the disease of hepatitis and the treatment of hepatitis; 3) improving     willingness to seek medical care for hepatitis C; 4) completing the 3 sessions on alcohol use     reduction; 5) completing the 3 session Hepatitis A and B vaccine; and 6) determining the     number of self-reported 12 step alcohol treatment program sessions attended.   "
237197|NCT00958776|"     A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy     and safety of peramivir administered intravenously in addition to standard of care compared     to standard of care alone in adults and adolescents who are hospitalized due to serious     influenza.   "
237198|NCT00958789|"     This study will be a prospective, non-randomized evaluation of the change between     preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee     System for a revision knee operation. The mean total Knee Society Score (for pain, motion and     function) change is not 10% worse than, or is superior to, the expected change according to     published revision total knee replacement data, for cases implanted with the Triathlon® TS     Total Knee System as compared from preoperative to 2 years postoperative.   "
237214|NCT00962819|"     This study will lay the foundation for determining the underlying reasons for lack of     immunity to mumps that led to the 2006 mumps outbreak on college campuses in the Mid West,     and it will assess the potential for similar outbreaks of measles and rubella. A total of 70     to 80 college students (age 18 to 22) on the Emory campus (or nearby college campuses or the     community) will be assessed for antibodies to measles, mumps or rubella by drawing a one-time     blood sample. Their medical records will be verified for documentation of immunization with     MMR vaccine prior to enrollment in the study. If a study volunteer is found to not have MMR     immunity, they will be offered an MMR-II vaccine. For this group, additional blood specimens     will be obtained.   "
237215|NCT00962832|"     This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to     evaluate the efficacy and safety of rontalizumab compared with placebo in patients with     moderately to severely active systemic lupus erythematosus (SLE).   "
237199|NCT00958802|"     Platelet-rich plasma (PRP) has mixed growth factors such as TGF-ß1 and TGF-ß2, vascular     epithelial growth factor (VEGF), platelet-derived growth factor (PDGF), and insulin-like     growth factor (IGF). These growth factors appear to play an important role in wound healing     and are assumed as promoters of tissue regeneration. Moreover, PRP was used as injectable     scaffold seeded with chondrocytes to regenerate cartilage. In their previous study, the     investigators concluded that growth factors in PRP can effectively react as a growth factor     cocktail to induce human nucleus pulposus proliferation and differentiation, and also promote     tissue-engineered nucleus pulposus formation. The investigators also have a hypothesis that     PRP can promote tissue-engineered microtia auricular cartilage formation. TGF- ß1 exists in     the highest concentration and is more important among all of the growth factors released from     PRP. So TGF- ß1 can be used as the core ingredient and the indicator for applying PRP in     these studies. The aim of this study was to compare the histological and biochemical     character of microtia chondrocytes treated with and without PRP.   "
237200|NCT00958815|"     People with diabetes are at increased risk for atherosclerosis and have high CVD morbidity     and mortality rates. Tools for detecting and quantifying atherosclerotic pro/regression in     people with diabetes and other CVD risk factors lack sensitivity and specificity for     molecular level events that occur during the early stages of atherogenesis. Inflammatory     macrophage infiltration in the vessel endothelium is an early, molecular level proatherogenic     event. Activated macrophages consume glucose at a high rate. Novel in vivo radiotracer PET/CT     techniques have been developed to detect, image and quantify molecular level events like     macrophage inflammation and glucose utilization (18FDG) in human vessels. We propose to     develop and test this novel technique in the Center for Clinical Imaging Research (CCIR) at     WUMS. We propose that HIV-infected people with significant CVD risk profiles are a suitable,     unique human model for testing these novel imaging techniques. HIV-infected people taking     anti-HIV medications develop insulin resistance, T2DM, dyslipidemia, central adiposity, and     hypertension. HIV replicates in macrophages and represents a chronic proinflammatory     condition. Recent data indicate that HIV+ CVD risk have greater risk for atherosclerosis and     MI than HIV-negative people. To test feasibility, we hypothesize that: a.18FDG-PET/CT imaging     will detect more macrophage glucose uptake and inflammation in the carotid and aorta arteries     of HIV-infected people with CVD risk than in HIV-negative controls; b. radiotracer PET/CT     measures of proatherogenic processes will correlate with carotid intima media thickness; a     standard measure of carotid atherosclerotic burden. We propose to obtain pilot data that     shows feasibility for a novel analytical approach that will expand capabilities for     researchers interested in studying the links between diabetes, inflammation, and CVD in     humans.   "
237201|NCT00958828|"     The purpose of this study is to evaluate the performance of two daily disposable contact     lenses in a population of daily disposable contact lens wearers.   "
237202|NCT00958841|"     This study will assess the effectiveness and safety of pasireotide long-acting release in     patients who have rare tumors of neuroendocrine origin.   "
237203|NCT00958854|"     RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Thalidomide may stop the growth of lymphoma by blocking blood flow to the     cancer. Giving fludarabine and cyclophosphamide together with thalidomide may kill more     cancer cells.      PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide     together with thalidomide works in treating patients with angioimmunoblastic T-cell lymphoma.   "
237204|NCT00958867|"     Alzheimer's disease (AD) is a major health issue in Canada; it affects over 8% of the     population aged over 65 years. Persons with AD have a reduced quality of life as they become     dependent on others for activities of daily living (ADLs). This problem of loss of     independence - functional dependence - is one focus of this grant application. It is     projected that by 2020, Canada will have well over 10 million seniors with moderate to severe     functional dependence. Functional dependence was the most significant contributor to an     annual cost of dementia that had already reached $4 billion in the 1990s.      Mild cognitive impairment (MCI) is a well-recognized risk factor for both AD and functional     dependence. Within the broader assessment of cognitive function, the literature suggests that     executive functioning - the ability to concentrate, to attend selectively, to plan and     strategize - is a robust cognitive predictor of functional status in seniors. Specifically,     Royall and colleagues demonstrated executive functioning independently explained 43% of the     functional status in community-dwelling seniors dementia. The researchers will investigate     executive functioning in seniors with MCI.      Randomized trials of various exercise interventions have proven that exercise has many     systemic benefits. Data are emerging that physical activity may improve cognition -     specifically executive function - in healthy adults. The researchers' own pilot data suggest     that resistance training in seniors may improve executive functioning as assessed by     neuropsychological tests and neuro-imaging. However, at present the Cochrane Database of     Systematic Reviews indicates there are insufficient published data to guide exercise     prescription to prevent AD. In persons with MCI, no published studies have reported on     whether physical activity can improve executive function, or delay its decline and thus,     prevent or delay the onset of functional dependence (and later, dementia).      Therefore, among seniors with MCI, the researchers will investigate whether or not specific     exercise prescription can: 1) provide absolute or relative improvement in cognitive function,     particularly executive function; and 2) help maintain functional independence. This will     facilitate the development of effective exercise-based strategies for the prevention of both     cognitive and functional decline in the large population of seniors with MCI - people at     greatly increased risk for AD.      The researchers' proposed research aims to ascertain whether a six-month, twice-weekly     aerobic training (AT) program and a six-month, twice-weekly resistance training (RT) program,     compared with a six-month, twice-weekly stretch & relax (S & R; control) program, will     significantly improve cognition and functional status in community-dwelling women with MCI     aged 70 years and older.      Primary Hypothesis:      At the end of six-month randomized trial, compared with the S & R program, both the AT and RT     programs will significantly improve cognitive performance, as assessed by neuropsychological     testing.      Secondary Hypotheses:      At the end of the six-month randomized trial, compared with the S & R program, participants     of the AT and RT programs will:        1. Demonstrate evidence of cortical plasticity by fMRI, such as increased activation in          cortical regions responsible for item and relational memory; and        2. Will significantly improve their everyday problem solving ability.   "
237205|NCT00958880|"     The purpose of this study is to investigate the utility of Yohimbine hydrochloride for     facilitating fear extinction in a sample of patients with social phobia who will be treated     with CBT.   "
237206|NCT00958893|"     An open label, extension study for subjects completing the ZPU-003 Ext 1 study.   "
237207|NCT00962728|"     The investigators will test whether breathing through an inspiratory resistance device will     improve the ability to be upright and decrease heart rate increases on standing in patients     with postural tachycardia syndrome.   "
237208|NCT00962741|"     This study will evaluate the effect of etanercept on the clinical benefit, safety, and     physical functioning (ability to function in daily life) in children and adolescent subjects     with 3 subtypes of childhood arthritis.   "
237209|NCT00962754|"     The purpose of this study is to determine if routinely recording fluid balance in sick     neonates admitted to the pediatric ward is reliable and useful. The investigators' hypothesis     is that it is not useful and reliable.   "
237210|NCT00962767|"     The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL     patients in achieving first hematological complete remission and molecular remission.   "
237211|NCT00962780|"     The study will evaluate the safety, tolerability and immunogenicity of a 13-valent     pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who     have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3     doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with     each dose given approximately 1 month apart.   "
237212|NCT00962793|"     The investigators think that the health care workers who contact frequently with active     tuberculosis patients have more increased prevalence of LTBI compared with those who don't.   "
237213|NCT00962806|"     Obesity and type 2 diabetes are occurring at epidemic rates in the United States and     worldwide. The global burden of diabetes is estimated to double over the next 25 years. Obese     children are at risk for the development of insulin resistance, relative insulin deficiency     and type 2 diabetes mellitus (DM). The prevention of type 2 DM is hindered by the lack of a     non-invasive predictive test, knowledge as to individual risk and effective preventative     measures. There is increasing evidence that alterations in mitochondria contribute to the     development of diabetes in humans. Therefore, it is important to explore mitochondrial     dysfunction as a potential predictor of diabetes in children and a potential target for     prevention. The aims of the proposed protocol are to determine whether an intensive exercise     intervention can improve mitochondrial function in children identified as having     mitochondrial dysfunction and insulin resistance. The use of a non-invasive imaging technique     will allow for a functional in vivo assessment of mitochondrial activity. The investigators     propose the investigation of an intensive exercise protocol designed to improve mitochondrial     function in children who are insulin resistant and have documented mitochondrial dysfunction     by magnetic resonance spectroscopy. The study is designed to investigate the plasticity of     abnormal mitochondrial function in high risk children. In summary, the proposed projects will     investigate mitochondrial function as a non-invasive predictive marker for the development of     insulin resistance and type 2 diabetes mellitus in children and attempt to modify     mitochondrial function with an intensive exercise intervention. The study of mitochondrial     dysfunction in children may both identify those at risk for disease and provide a molecular     therapeutic target for prevention and treatment.      The investigators hypothesize that children with insulin resistance and mitochondrial     dysfunction who are randomized to intensive exercise versus standard lifestyle advice will     show improvement in mitochondrial function and insulin sensitivity.   "
237216|NCT00962845|"     RATIONALE: Studying samples of blood, tumor tissue, and skin in the laboratory from patients     with melanoma receiving hydroxychloroquine may help doctors understand the effect of     hydroxychloroquine on biomarkers.      PURPOSE: This early phase I trial is studying hydroxychloroquine in patients with stage III     or stage IV melanoma that can be removed by surgery.   "
237336|NCT00964470|"     The purpose of this study is to compare the rate of healing and the non-adherence of three     types of dressings. The study will also compare rate of infection, scarring and perception of     pain associated with treatment.   "
237217|NCT00962871|"     This open-label, randomized, parallel-arm study will assess the early immunologic response in     treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment     with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4     cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally     daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may     opt to receive standard of care treatment with Pegasys. Target sample size is <50.   "
237218|NCT00962884|"     The investigators will test whether breathing through an inspiratory resistance device will     improve the ability to be upright and decrease blood pressure drops on standing in patients     with orthostatic hypotension.   "
237219|NCT00962897|"     A retrospective review with four year followup on patients that had previously been enrolled     in a study to evaluate blockages in the lower legs. The study looked at patients that had     undergone a bypass of the leg from the groin to the knee area with an incision in each area     using general anesthesia. These patients were compared to others who had undergone treatment     with balloon dilatation and stents in the arteries in the thighs with only numbing medicine.     The study was completed two years ago and was initially designed to look at outcomes at 24     months. Now the investigators are trying to go back and look at outcomes of these patients'     treatment at 4 years by simply reviewing their records.   "
237220|NCT00962910|"     Care pathways, a complex intervention to (re)organise, standardize and evaluate care     processes, are used worldwide and in different kinds of settings. Although their     international use, the impact is unclear. The European Quality of Care Pathways Study is the     first international cluster Randomized Controlled Trial on the effect of care pathways for     proximal femur fracture patients (PFF).      The hypothesis is that teams who work with care pathways for PFF patients deliver care that     is more compliant to evidence based key interventions, have better patient outcomes and     higher scores on team indicators than teams who do not work with care pathways.   "
237221|NCT00962923|"     This study will explore safety and efficacy of allogeneic mesenchymal stem cells     transplantation (MSCT) to treat patients with diagnosis of systemic sclerosis(SSc) who have     been resistant to multiple standard treatments. The underlying hypothesis is that the SSc     condition is caused by an abnormal immune homeostasis that can be restored by MSCT.   "
237222|NCT00962936|"     This study aims to evaluate whether an investigational monoclonal antibody, CT-011, is safe     to give and if it helps patients with hepatitis C virus (HCV). Monoclonal antibodies are a     type of drug that is typically given by infusion into a vein (intravenously). Results of this     trial will help doctors obtain additional information with regard to the safety and efficacy     of CT-011 as a potential treatment for HCV.   "
237223|NCT00962949|"     The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in     the pathophysiology of postural tachycardia syndrome, and to provide an insight about the     disease process in this disorder.   "
237224|NCT00962962|"     The purpose of the study is to evaluate the effects of different amounts and intensities of     aerobic exercise training programs, with and without weight loss, in people who are at risk     for diabetes. An additional purpose of the study is to evaluate the factors in the blood and     in exercising muscles that contribute to the improvement in those risk factors. This     information will be used to improve exercise training guidelines for improving cardiovascular     and metabolic health in people with abnormal fasting glucose, also known as prediabetes.   "
237225|NCT00962975|"     In this open-label multicenter study the long-term effect of Pegasys monotherapy on     pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis     B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512)     and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once     weekly) for up to 48 weeks. Target sample size is <100.   "
237226|NCT00962988|"     Research Aims      The aims of this research study are to determine whether cost-free smoking cessation     pharmacotherapy:        1. Helps smokers with Transient Ischemic Attack (TIA) or stroke to quit smoking over the          long-term, compared to simply providing a prescription for these medications;        2. Is a more cost-effective alternative to providing a prescription only for these          medications in this high risk population.      Hypotheses to be Tested      The hypotheses to be tested include the following:        1. The CO-validated continuous abstinence rate at weeks 26 and 52 following a target quit          date will be at least 10% higher for the cost-free smoking cessation pharmacotherapy          intervention group compared to the prescription only usual care group;        2. Cost-free smoking cessation pharmacotherapy will have a greater cost-effectiveness          (i.e., cost/quit) than providing a prescription only.   "
237227|NCT00963001|"     The purpose of this study is to assess the pharmacokinetic and safety profile of a single     dose of oral treprostinil following four different meals of varying caloric and fat content.   "
237228|NCT00963027|"     The purpose of this study is to evaluate the effect of esomeprazole, a proton pump inhibitor,     on treprostinil pharmacokinetics.   "
237229|NCT00963040|"     The objective of this prospective, randomized, double-blind, parallel-group,     placebo-controlled study is to determine the effectiveness of intranasal oxytocin in subjects     suffering from chronic daily headache. The primary outcome measure is the reduction in     headache intensity after drug administration; secondary outcome measures are the headache     symptoms, nausea, vomiting, photophobia, and phonophobia. Additional secondary outcome     measures are intake of rescue medication and patient satisfaction over a period of 24 hours.   "
237230|NCT00963053|"     The purpose of the study is to investigate how effective VA111913 is at preventing menstrual     pain in women with primary dysmenorrhoea.   "
237231|NCT00963066|"     Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist NAVA in patients     who recover spontaneous breathing after acute lung injury.   "
237232|NCT00963079|"     This study tests the hypothesis that controlled ovarian stimulation impairs endometrial     receptivity in high responders.   "
237233|NCT00963092|"     RATIONALE: Collecting and storing samples of tissue, blood, and saliva from patients with     cancer to test in the laboratory may help the study of cancer in the future.      PURPOSE: This research study is collecting blood and tissue samples from patients with     stomach cancer, esophageal cancer, or gastroesophageal junction cancer, studying them in the     laboratory, and storing them for future studies.   "
237235|NCT00963118|"     To achieve optimal health and to reduce the risk of age-related chronic diseases through an     easily achievable dietary modification not achievable by the limited mixture of antioxidant     supplements in older subjects, the investigators will focus their attention on the biological     functions of bioactive plant food (Angelica keiskei and/or Glycine max) and its effect on     genomic stability using noble assays.      The investigators propose to study the ability of bioactive plant-based food (Nutrition bar     made from Angelica keiskei and/or Glycine max) to 1) exert biological functions: increase     total antioxidant performance, decrease oxidative stress in vivo, and 2) affect genomic     stability: decrease DNA damage and modify DNA methylation. The investigators hypothesize that     bioactive plant food (green leafy vegetable power, and/or black bean power) will exert     biological functions and affect genomic stability far more efficiently than the limited     mixture of purified antioxidant supplements in the vulnerable population, older subjects (>     50 years, men and postmenopausal women) with and without metabolic syndrome.   "
237236|NCT00963131|"     Central serous chorioretinopathy (CSC) is the serous neurosensory detachment that usually     involves the macular area. It is common in patients between 30-50 years old and effects male     more often than female with the ratio of 5-10. The common risk factors are psychologic     stress, type A personality, systemic steroid use, hypertension and pregnancy. The treatment     is usually observation especially in the first three-months. The laser or photodynamic     therapy should be considered when the condition does not improve after that time.     Nevertheless, the pathogenesis of CSC is still not well understood but the study from     indocyanine green angiography showed the choroidal vascular hyperpermeability and abnormal     leakage. The causes of this abnormality are supposed to be from nitric oxide, prostaglandins     or even free oxidative radicals. From this hypothesis, the oxidative process might be     involved in the pathogenesis of the disease especially in the early stage. This study is to     determine the effect of antioxidants drugs in the acute stage of CSC and to determine whether     they can improve the outcomes of the disease.   "
237237|NCT00963144|"     The purpose of the study is to determine the applicability and utility of Gerd Q in the     diagnosis of GERD and in the assessment of treatment response.   "
237238|NCT00963157|"     The purpose of this study is to see how the body reacts to different strengths of the H1N1     flu shot when it is given with or without an adjuvant. An adjuvant is a substance that may     cause the body to produce more antibodies when it is given with a vaccine. This study will     also compare how age affects the body's response to the H1N1 flu shot. In this study, 3     strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2     strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the     same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will     include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250     individuals greater than or equal to age 65. Study procedures include: physical exam, blood     samples, completing a memory aid to record vaccine side effects, medications and daily oral     temperature. Participants will be involved in study related procedures for up to 13 months.   "
237239|NCT00963183|"     The aim of the study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of AZD5423 following single ascending dose administrations in healthy male     subjects.   "
237240|NCT00963196|"     This study will be a randomized controlled trial set in an outpatient clinic, involving     patients with major depressive disorder, who will be treated with antidepressant therapy,     which will be individually agreed upon by the subject and his or her physician. Patients will     be randomized to receive either placebo or fish oil capsules containing eicosapentaenoic acid     (EHA) and docosahexaenoic acid (DHA) in addition to their antidepressant medication. Subjects     will complete a brief dietary and exercise habits survey at the beginning of the trial to     take into account lifestyle factors that may be significant in symptom resolution. Their     progress will be monitored over a period of twelve weeks, with standardized rating scales     completed by subjects and treating physicians. At the end of the study, scores will be     compared between groups to look for differences in timing and degree of symptom improvement     to analyze whether improvement occurred faster in the group receiving essential fatty acids     (EFAs) than in the one receiving placebo. The primary hypothesis is that supplementation of     antidepressant therapy with omega-3 fatty acids will decrease the lag period between the     start of therapy and the time of clinically significant symptom improvement. A secondary     hypothesis is that the results of this study will be consistent with numerous previous     studies showing improvement in symptom control in major depressive disorder when     antidepressants are supplemented with omega-3 fatty acids.   "
237241|NCT00963209|"     RATIONALE: Estrogen can promote growth of endocrine sensitive breast cancer cells. Endocrine     therapy with tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the     tumor cells. Pharmacokinetics and -genomics can have an impact on the efficacy of the     treatment.      PURPOSE: This phase III trial is studying blood samples to see if the level of active     metabolites of tamoxifen can be improved in patients with breast cancer.   "
237242|NCT00963222|"     The aim of this study is the comparison between the effects of supplementation with 25000 IU     preformed vitamin A (retinyl palmitate) or placebo for 3 months on immune system and Th1/Th2     balance in patients with and without atherosclerosis (documented with angiography).   "
237243|NCT00963235|"     The study will evaluate the safety, tolerability and immunogenicity of a 13-valent     pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who     have been previously immunized with at least one dose of 23-valent pneumococcal     polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study     vaccine dose given approximately 6 months apart.   "
237244|NCT00963248|"     Question:      In which stage of an EBV-infection is a selective reduction of immunosuppressive medication     reasonable to minimize the risk for PTLD, without putting the transplant recipient at risk of     acute rejection episodes due to under immunosuppression?      Aim of study:      Identification of patients at high-risk for PTLD.   "
237245|NCT00963261|"     The purpose of this study is to analyse the physical and psychological side-effects in the     course of treatment with IFN-alpha. The effectiveness of a specific intervention for the     management of these side-effects is evaluated.   "
237464|NCT00965406|"     The aim of this study is to evaluate the effect of the glucose insulin potassium (GIK)     infusion associated with intensive insulin therapy compared to GIK alone and control group in     patients presenting to the ED with acute coronary syndrome.   "
237246|NCT00963274|"     This phase I trial studies the side effects and best dose of giving bortezomib and romidepsin     together in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic     lymphoma (SLL), indolent B-cell lymphoma, peripheral T-cell lymphoma (PTCL) or cutaneous     T-cell lymphoma (CTCL). Bortezomib and romidepsin may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth.   "
237247|NCT00963287|"     The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription     on Ulcerative Colitis.   "
237248|NCT00963300|"     RATIONALE: Diagnostic procedures, such as MRI, may help measure oxygen levels in tumor cells.     It may also help doctors predict a patient's response to treatment and help plan the best     treatment.      PURPOSE: This clinical trial is studying how well MRI works in assessing hypoxia in patients     with localized prostate cancer undergoing stereotactic body radiation therapy.   "
237249|NCT00963313|"     Based on published data and according to the approved product label for ankylosing     spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days     should be effective in psoriatic arthritic patients with axial involvement.   "
237250|NCT00963326|"     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study is looking at blood and tissue samples from patients with larynx     cancer, pharynx cancer, or oral cavity cancer.   "
237251|NCT00963339|"     The purpose of this study is to evaluate the usability of the Foresee Home device with     intermediate AMD patients.   "
237252|NCT00963352|"     1. Radical surgery. It is supposed to improve prognosis of colon cancer. A surrogate          measure of achievement of radical surgery is the number of lymph nodes removed with the          specimen.        2. Markers. There may be variables that may make patient assessment more sound. The project          is including investigation of such markers (genes, old age, comorbidity, and others).        3. Laparoscopic resections. This is being used more and more in cancer surgery but the          feasibility of this approach remains to be proven compared with conventional open          surgery. The project compares these according to 1) and 2).        4. Morbidity and mortality must be surveilled to keep at a minimum. Many patients have          comorbidity and are old to make this factor extra important, including perioperative          care.        5. Proper treatment of colon metastases may prolong life. Treatment of lung-metastases will          be studied in particular.   "
237253|NCT00963365|"     The purpose of this study is to determine the safety of AZD6765 when given in single and     multiple oral doses and to compare an oral and intravenous (IV) formulation of AZD6765 to     placebo.   "
237254|NCT00963391|"     The purpose of this study is to conduct a Randomized Control Trial (RCT) in a developing     country setting in order to evaluate the role of alcohol based hand sanitizers (ABHS) in     preventing the transmission of infectious diseases in areas where water is a scarce resource.     The investigators want to find out if the use of ABHS reduces the incidence of two leading     causes of morbidity and mortality in children under 5 years of age in the developing world:     acute diarrheal disease (ADD) and acute respiratory infections (ARI).   "
237255|NCT00963404|"     The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The     bladder cancer patients included in the study will undergo tumor demarcation. The bladder     demarcations will then be the target for an image-guided boost delivered precisely to the     expected tumor site.   "
237256|NCT00963417|"     RATIONALE: Gathering information over time from bone density and laboratory tests of women     with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of     breast cancer in the future.      PURPOSE: This clinical trial is studying changes in bone mineral density in women with breast     cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02 (TEXT).   "
237257|NCT00963430|"     The purpose of this study is to evaluate an investigational 2009 H1N1 influenza vaccine to     determine vaccine safety in pregnant women and the body's immune response (body's defense     against disease) to different strengths of the H1N1 influenza vaccine. In this study, 2     strengths of the H1N1 influenza vaccine will be tested (given 3 weeks apart). Participants     will include approximately 120 healthy pregnant women, ages 18-39 years, in their second or     third trimester of pregnancy (14-34 weeks gestation). Study procedures will include 2 doses     of vaccine, blood samples, cord blood samples at delivery, and recording temperature and     vaccine side effects in a memory aid for 8 days following each vaccination. Participants will     be involved in study related procedures for about 7 months.   "
237258|NCT00963443|"     The purpose of the study is to determine the effectiveness of an acetylsalicylic acid     (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms     compared to the effectiveness of the individual components of the medicine and the placebo     (dummy treatment that looks like the real thing).The combination product of acetylsalicylic     acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.   "
237259|NCT00963469|"     This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning,     versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the     study as an active control.   "
237260|NCT00963482|"     Most alcohol-dependent individuals are heavy smokers. The aim of this study is to evaluate     whether a specific smoking cessation program (based on cognitive-behavioral therapy) for     inpatient alcohol-dependent smokers is more effective than a control condition (treatment as     usual).   "
237261|NCT00963495|"     This is an open-label, single arm phase 1 study to evaluate the dose-limiting toxicity,     maximum tolerated dose, and recommended phase II dose of Clioquinol in patients with relapsed     or refractory hematologic malignancies. The study will also characterize Cliquinol's safety,     tolerability and pharmacodynamic effect.   "
237262|NCT00963508|"     In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for     head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an     established head lice treatment. The new formulation has been evaluated in 2 previous studies     of patients 2 years of age and older.   "
237263|NCT00963521|"     RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune     response to kill cancer cells.      PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how     well it works in treating patients with acute myeloid leukemia in complete remission.   "
237267|NCT00963573|"     This study attempts to document the therapeutic value of combining loratadine antihistamine     action (no sedative) with anti-inflammatory effects of betamethasone at low doses, which may     facilitate treatment adherence by patients whereas providing an effective and rapid perennial     allergic rhinitis (PAR) symptoms relief.   "
237268|NCT00963586|"     Rationale: Due to advanced technologies in the last decade, increasingly more treatment     options are available for head and neck cancer (HNC). As a consequence decision-making with     regard to choosing the best available treatment option is becoming increasingly relevant.     Quality of life weights (utility scores) are an important outcome measure in this     decision-making process. Utility scores can be combined with life expectancy, resulting in     the Quality Adjusted Life Year (QALY). If in economic evaluation the outcomes are expressed     in QALYs gained, it is possible to compare the efficiency of different interventions for     different indications. However, limited evidence on utility scores after treatment for HNC is     available.      Objective: The investigators' main objective is to examine quality of life (QoL), both     utility scores and disease specific quality of life, for different treatment modalities in     HNC. Secondary objectives are to examine whether QoL differs across health states, and which     factors influence QoL. As extensive data are available on disease-specific quality of life,     another objective is to examine whether utility scores can be derived from a commonly used     disease-specific questionnaire, the EORTC QLQ-C30/QLQ-H&N35. If this would be possible, this     would limit patient burden in future clinical trials. Finally, by means of measuring     patients' ability to perform their work, diet and dental consequences the investigators aim     to measure the impact of HNC and its treatment.      Study design: The investigators' study design is a cross-sectional survey.      Study population: The study population consists of patients with HNC who are treated at least     six months ago for curative radiotherapy and/or surgery with or without chemotherapy.      Intervention/method: Patients are asked to fill out a single set of questionnaires     (once-only). The set of questionnaires consists of three validated questionnaires, concerning     health state utility (EuroQol-5D), disease-specific quality of life (EORTC QLQ-C30/QLQ-H&N35)     and productivity losses (PRODISQ). In addition, two questions inquiring about patients' diet     and three questions considering the dental status of these patients are added to the     questionnaires. To classify patients into certain health states, physicians are asked to     score adverse events in patients during follow-up visits (according to the RTOG     classification).      Main study parameters/endpoints: The main study parameter is QoL (both disease specific     quality of life and utility scores) in a certain health state. These utility scores can be     used in future cost-effectiveness studies to identify the best available treatment option.     Other important study parameters are the factors influencing QoL, and the relationship     between utility score and disease-specific quality of life.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: As the study involves a once only set of questionnaires, the burden is only     minimal. No risks are expected to be associated with participation. It is important to gain     insight into QoL, patients' ability to perform their work, diet and dental consequences in     long-term follow-up of HNC patients, to allow for evidence-based decision-making regarding     treatment options for HNC.   "
237269|NCT00963599|"     This study will evaluate the ability of oral montelukast/loratadine to improve the signs and     symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and     placebo.   "
237270|NCT00963612|"     Liver resection and liver transplantation are the acceptable treatment of Hepatocellular     Carcinoma (HCC). But the long-term survival is unsatisfactory as a result of high rate of     intra and extra hepatic recurrences. Microvascular invasion (MVI) is the most significant     risk factor affecting recurrence-free survival in patients following liver resection and     liver transplantation. Tumor hypoxia (lack of adequate blood supply) is the single most     important factor that predict MVI and post surgical prognosis.      Blood Oxygen Level Dependent (BOLD) MRI is a non-invasive diagnostic method of assessing     tumor hypoxia by detecting signal changes secondary to changes in blood flow and oxygenation.     BOLD MRI assessment of tumor hypoxia in HCC has never been correlated with pathological     confirmation of MVI, the gold standard to assess MVI in HCC. In this study, the investigators     propose to assess the ability of BOLD MRI to provide a discriminating quantitative threshold     of intratumoral oxygenation predictive of MVI.   "
237271|NCT00963625|"     This study tests the hypothesis that controlled ovarian stimulation impairs endometrial     receptivity in normal responders.   "
237272|NCT00963638|"     The goal of this study is to evaluate the effectiveness of magnesium supplements (MagTabSR     168 mgs twice daily) for relief and/or improvement in the frequency, duration, and intensity     of chronic leg cramps. Improvement in sleep disturbances and quality of life will also be     evaluated.   "
237273|NCT00963651|"     To perform a multiple reader, multiple case (MRMC) observer study assessing the detection     performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.   "
237274|NCT00963664|"     The purpose of this study is to determine whether an outpatient combination of lovastatin and     low-to-moderate dose interferon is effective in the treatment of patients with malignant     melanoma.   "
237275|NCT00963677|"     Difficult airways is still a challenging issue for the anesthesiologists in spite of the     development of various techniques.Shikani optical stylet(SOS), combining the features of     fiberoptic bronchoscope and a lightwand, has been used for orotracheal intubation with     difficult airways. As compared with fiberoptic bronchoscope, SOS is less expensive, easy to     learn and more durable. However, it remains elusive whether SOS can be used in the     nasotracheal intubation in the oral and maxillofacial surgery, which normally requires the     nasotracheal intubation. The present study evaluates the safety and efficacy of SOS for     nasotracheal intubation in the oral and maxillofacial surgery requiring nasotracheal     intubation.   "
237276|NCT00963690|"     The purpose of this study is to evaluate the safety and efficacy of the CloSys Hemostatic     Device designed to stop bleeding after an interventional procedure.   "
237277|NCT00963703|"     The purpose of this study is to determine how well Rituximab works in early stages of disease     and the effects it has on an inflamed joint and blood cells.      This will allow the investigators to get a better understanding of how this treatment affects     the inflamed joints of rheumatoid arthritis (RA) patients.   "
237278|NCT00963716|"     A new electrocautery bronchoscopy biopsy forceps is now commercially available and may     prevent bleeding following biopsy. Only one study used this device wherein the authors     concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have     a negative impact on the pathological samples, and that there was a statistically     significant, albeit clinically insignificant reduction in bleeding score with hot biopsy     forceps. Therefore, a randomized controlled study is required in which the hot and cold     biopsies are performed to evaluate the tissue effect of the hot biopsy forceps on     histopathological diagnosis.   "
237279|NCT00963729|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Estrogen can stimulate     the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by     reducing the production of estrogen. It is not yet known whether giving more than one drug     (combination chemotherapy) or giving letrozole before surgery is more effective in treating     women with breast cancer.      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy before     surgery to see how well it works compared with letrozole given before surgery in treating     postmenopausal women with breast cancer that can be removed by surgery.   "
237281|NCT00963755|"     The purpose of this study is to demonstrate that realization of guided biopsies by multimodal     imaging with 18F-fluorocholine PET / CT and MR Imaging/spectroscopy would allow to increase     the rate of detection prostate cancer compared with the current approach and give an     information about location and tumoral volume before surgery.:   "
237282|NCT00963768|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (ie,     blood levels of JNJ-28431754) and pharmacodynamics (ie, urine and blood levels of glucose) of     JNJ-28431754 compared to placebo in patients with Type 2 diabetes mellitus.   "
237283|NCT00963781|"     Despite the benefit of drug-eluting stents (DES) to reduce the need for repeat     revascularization procedures, concerns regarding late stent thrombosis (ST) have led to     recent guidelines advocating extended prescription of dual antiplatelet therapy (DAPT) with     aspirin and a thienopyridine (clopidogrel or ticlopidine]) beyond that described in the     product labeling. Specifically, an advisory has recommended at least 1 year DAPT following     treatment with DES in patients without contraindications. However, this recommendation was     largely empiric and not based on any trial showing reductions in ST with long-term DAPT, nor     are potential safety differences between DES considered. Further, no study has examined the     balance in potential efficacy with long-term DAPT relative to an increased bleeding risk.      A consistency across clinical trials involving the Endeavor DES has been very low rates of     late myocardial infarction, cardiac death and ST. Unlike other DES, recent studies indicate     that the Endeavor stent may permit more rapid and complete healing over stent struts in     addition to restoring normal blood vessel function. Further, in patients treated with the     Endeavor stent, long-term safety outcomes are similar through 3 years follow-up irrespective     of whether patients were adherent to DAPT for durations of ≤ 6 months, 12 months or 24     months.      In this study, long-term safety and effectiveness will be examined for patients treated with     the Endeavor stent and assigned to DAPT for reduced duration of 6 months. If the study     demonstrates safety and efficacy, it could influence treatment guidelines in favor of an     abbreviated duration of DAPT for patients treated with the Endeavor stent. This would mean     that should a bleeding complication or need or surgery arise less than 12 months post-PCI,     patients treated with the Endeavor stent could stop DAPT after 6 months with reasonable     estimate of safety. Furthermore, it is possible that patients who are currently denied DES     due to known need for elective surgery could be treated with the Endeavor stent in cases     where surgery can be temporarily delayed. Finally, it could be an additional option for     patients who forgo treatment with DES in favor of bare metal stent (BMS) out of fear of     possible bleeding with long-term DAPT.      Finally, it is recognized that not all patients respond the same way to anti-platelet     therapy. Recent studies have indicated that inherited genetic variations in the way the body     metabolizes anti-platelet medications may be important determinants of responsiveness to     thienopyridine therapy, and that such differences may also confer a higher likelihood of     adverse outcome. Patients agreeing to the additional genetic sub-study will have a DNA sample     taken at baseline to test for the presence of such genes related to antiplatelet therapy     metabolism and effectiveness. The results of these tests could help the medical community to     better understand individual variation in response to anti-platelet therapy and the role that     genetics may play in determining the response. It is possible that the information gained     could help physicians tailor DAPT on a patient by patient basis.   "
237284|NCT00963794|"     The aim of the present prospective study was to evaluate the prediction accuracy of     electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively     enrolled in the investigators' Institute and subjected to electromagnetic detection followed     by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was     attributed to subjects showing an electromagnetic signal < 50 units (U).   "
237285|NCT00963807|"     This study is being done to compare a special type of Positron Emission Tomography (PET) scan     with CT scan in patients with surgically removable lung cancer to see which method is more     useful in measuring a response to treatment. A PET scan uses small amounts of radioactive     material injected into the blood to show the internal workings of the body. In this study, we     will use two radioactive materials: 18F-FLT (referred to as FLT) and 18F-FDG (referred to as     FDG). FDG is used routinely in the staging of lung cancer and is approved by the FDA for that     purpose. FLT is used in the special type of PET scan being assessed by this study. In     addition the study will assess the effects of the combination of docetaxel and cisplatin     (chemotherapeutic drugs) on certain pathological characteristics of the tumor. The     combination of docetaxel and cisplatin is approved by the Food and Drug Administration (FDA)     for the treatment of advanced/metastatic NSCLC (non-small cell lung cancer). It is not     approved for use in patients who have surgically removable NSCLC. In such cases cisplatin is     used as a single drug therapy before surgery. The FDA is allowing the use of docetaxel along     with cisplatin in this research study.   "
237286|NCT00963820|"     The primary objective of this study is to determine the safety profile, tolerability, and     maximum tolerated dose of ixazomib citrate (MLN9708) when taken orally on a weekly dosing     schedule by patients with relapsed and refractory multiple myeloma (RRMM). Secondary     objectives include pharmacokinetics and response rates.   "
237287|NCT00963833|"     Multiple Sclerosis (MS) is mainly known as a disease of young to middle adulthood but     approximately 5% of all MS cases worldwide involve children that are younger than 16 years.      The aim of care of children with Multiple Sclerosis is to prevent or at least to delay any     neurological and cognitive impairment as well as progression of the disease as far as     possible. Therefore, it is very crucial to diagnose the disease at an early stage as     immunomodulatory treatments are available that can delay the progression of Multiple     SclerosisTreatment with the immunomodulatory agent Betaferon® in children diagnosed with RRMS     and being 12 years or older has been approved by the health authorities. The aim of this     observational study is to obtain further data on the safety, tolerability, and effectiveness     of Betaferon® under daily living conditions.      As this is a non-interventional observational study, routine clinical practice is observed.     The application of diagnostic measures and medications as well as physician visits follow the     normal routine and is decided upon by the treating physician under recognition of the package     insert.   "
237288|NCT00963846|"     Huperzine is a natural plant product with procognitive properties in patients with     Alzheimer's disease. Cognitive difficulties hamper functioning in schizophrenia as well. The     present study will investigate whether huperzine improves cognition and functioning in     patients with schizophrenia.   "
237289|NCT00963859|"     The goal of this clinical research study is to evaluate how many lymph nodes are left behind     after robotic-assisted removal and are then found after a wider incision is made, in patients     who are having their bladder removed for the treatment of bladder cancer.      The primary objective is to compare the lymph node yield achieved by performing a     robotic-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) compared to a     second-look open lymph node dissection (O-PLND) among patients undergoing radical cystectomy     for transitional cell carcinoma of the bladder.      The secondary objectives will be to collect prospective outcomes data related to the     performance of RA-PLND and robotic-assisted cystectomy (RA-C) including operative times,     estimated blood loss, transfusions, complications, return to diet, utilization of pain     medication, hospital length, return to regular activities.   "
237290|NCT00963872|"     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor     umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the     patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-tumor effect).      PURPOSE: This phase I trial is studying the safety of donor umbilical cord blood transplant     after fludarabine phosphate, cyclophosphamide, and total-body irradiation in treating     patients with high-risk hematologic cancer (now closed).      The Phase II part of this trial is studying whether priming one of two UCB units with C3a     facilitates engraftment of the treated unit.   "
237291|NCT00963885|"     This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with     RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and     Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus     infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591     300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12     hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety     and virological response data from Part 1 of the study are supportive, in Part 2 patients     will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12     hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys     and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample     size is 100-500 individuals.   "
237292|NCT00963898|"     The aim of this study is to evaluate benefits of the method of dental sedation using Target     controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with     Mental Retardation and challenging behavior.   "
237294|NCT00963924|"     This study seeks to examine the effects of D-cycloserine augmentation on cognitive     remediation for patients diagnosed with schizophrenia. We will test the hypotheses that     D-cycloserine will significantly improve cognitive performance, negative symptoms, and     measures of functioning compared to placebo when combined with eight weeks of cognitive     remediation. We expect that these effects will persist when assessed at six-month follow up.   "
237295|NCT00963937|"     The purpose of this study is to evaluate the efficacy and safety of a range of doses of oral     sumatriptan for the acute treatment of migraine in children ages 10 to 17.   "
237296|NCT00963950|"     A safe and effective transvaginal approach accessing the abdominal cavity through the vagina     rather than the abdominal wall is today considered a routine approach for many gynecologic     surgeries.      First described by Dr. Ott in Germany in 1901, it is used routinely for transvaginal surgery,     for example, transvaginal hysterectomies. This transvaginal technique has been shown to     compare favorably to a laparoscopic abdominal approach because of less postoperative pain,     the total elimination of abdominal wall hernias and wound infections, earlier recovery and     better cosmesis.      Although routinely used in gynecological surgery, the advantages of the vaginal approach have     not been utilized for general surgery applications such as cholecystectomies. Open or     laparoscopic cholecystectomy accessing the abdominal cavity through abdominal wall incisions     is currently still considered the standard of care in general surgery for patients with     symptomatic gallbladder disease.      The investigators intend to access the abdominal cavity through the posterior vaginal fornix     instead of the transabdominal approach that is now performed routinely. So far, this method     of accessing the abdominal cavity through the transvaginal approach for the purpose of     performing intraabdominal general surgery.      The investigators' transvaginal approach has the strong potential to further decrease     invasiveness and take minimally invasive surgery to the next level in order to benefit the     patient even more by minimizing postoperative pain, eliminating the risk of abdominal hernias     and wound infections, improving cosmetic appearance and enabling the patient to return to     routine activity and work earlier. First preliminary studies show these advantages but     further research needs to be done to confirm these early positive results.   "
237297|NCT00963963|"     This study is developing and testing an innovative, parent education intervention, Preparing     Our Sons and Daughters for Healthy Futures. This intervention aims to reduce HIV risk among     African American and other Black youth living in high-poverty urban neighborhoods.     Investigators, working with a community advisory board and focus groups of youth and parents,     will develop a multi-year set of audio-CDs to promote positive parenting practices that     support young adolescents in establishing healthy patterns of behavior. This parent education     intervention will be tested in a field trial with families of 6th graders recruited from     multiple schools in New York City. Baseline and annual follow up surveys will be conducted     until youth enter high school. Families receiving the intervention will be compared to those     assigned to either an attention-controlled print materials condition or a non-attention     controlled condition. It is hypothesized that youth whose parents receive the intervention     will delay sexual initiation and report fewer sexual risks, and that their parents will     report more positive parenting practices.   "
237298|NCT00963976|"     Rationale: Management of blood pressure (BP) in the acute phase of intracerebral hemorrhage     (ICH) remains controversial. Although it has been established that there is a transient     moderate reduction of perihematoma cerebral blood flow (CBF) in acute ICH, the effect of BP     treatment is unknown. The potential for exacerbation of CBF has precluded routine aggressive     BP reduction.      Aim and Hypothesis: The primary study aim is to demonstrate the feasibility and safety of     acute BP reduction to < 150 mmHg systolic using a standardized protocol in ICH patients. It     is hypothesized that CTP will not demonstrate evidence of perihematoma ischemia following     acute BP reduction.      Design: ICH ADAPT is a randomized blinded endpoint trial. Acutely hypertensive ICH patients     are randomized to a target systolic BP of < 150 mmHg or < 180 mmHg. Patients are treated with     intravenous (IV) labetalol/hydralazine/enalapril.      Study Outcomes: The primary outcome is cerebral blood flow in the perihematoma region,     measured with CT perfusion, 2 hours after randomization. Secondary outcomes include the     difference in BP at 1 and 2 hours post-randomization in the two treatment groups and hematoma     expansion rates at 24 hours.      Discussion: ICH ADAPT is the only randomized trial designed specifically to identify any     hemodynamic changes in the perihematoma region secondary to aggressive BP management. The     results of this trial will facilitate ongoing and future studies aimed at determining the     efficacy of rapid BP reduction in acute ICH.   "
237299|NCT00963989|"     The primary objective of this clinical evaluation is to determine the safety and     effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from     symptom and with a known core infarct volume at admission. The secondary objective is to     determine if there is a correlation between infarct volume and functional outcome in treated     patients at 90 days post-procedure.   "
237300|NCT00964002|"     RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with     metastatic prostate cancer.   "
237301|NCT00964015|"     When people undergo major surgery, they require intravenous supplementation of fluids for a     number of reasons:        -  to compensate for no oral intake        -  to support blood pressure and organ function during and after surgery        -  to replace lost fluid or blood volume      There are a variety of fluid choices doctors have to provide to patients, and it is still not     definitively known whether some fluids are better than others in specific situations. This is     a particularly interesting question in patients undergoing heart surgery because of the     significant volume of fluids used over the entire course of hospitalization, including before     the operation, during the operation, and after the operation.      There has been some scientific evidence that the use of starch-based fluids (synthetic     colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given,     providing for better recovery from surgery. However, there has also been some scientific     evidence that the use of these fluids can harm kidney function. Importantly, none of these     large-scale studies were carried out specifically in patients undergoing heart surgery.      The purpose of this study is to answer the question of whether the use of starch-based fluid     in the heart surgery patient makes for a safer and faster recovery, causes kidney     dysfunction, or makes no discernable difference.   "
237304|NCT00964054|"     This pilot study may yield important research findings on how to adapt exercise treatment for     depression among adolescents. Potential public health benefits from this study include a     reduction of adolescent depression and problems associated with untreated depression in young     adults including suicide, substance abuse, cigarette smoking, teen pregnancy, impaired     psychosocial functioning and school failure. In addition, because this study prescribes     physical activity as a treatment for depression, additional public health benefits may     include a reduction in chronic diseases such as obesity, diabetes and heart disease, all of     which are associated with sedentary behavior.   "
237305|NCT00964067|"     The purpose of the study is to compare home-based aerobic interval training with supervised     interval training performed in groups or on a treadmill at the hospital.   "
237306|NCT00964080|"     The ongoing study is a Phase II, open-label study to evaluate the efficacy of MBP-426 at a     dose of 170 mg/m2 in combination therapy in patients with second line metastatic gastric,     gastro-esophageal junction or esophageal adenocarcinoma.   "
237307|NCT00964093|"     The purpose of this study is to determine whether silver alginate (Algidex) patch is     effective in the prevention of central line infections in very low birth weight infants.   "
237308|NCT00964106|"     The purpose of this study is to identify and validate a probe cocktail for use in future     drug-drug interaction studies. Cytochrome P450 enzymes and transport proteins play important     roles in the disposition of drugs. Changes in the activity of these pathways can be assessed     using probe drugs selected on the basis of their metabolic or transport pathway. This will be     a two part study with the same subjects participating in both parts to decrease variability     in data. The purpose of Part 1 is to identify a set of probe drugs ('cocktail') which do not     interact with one another; groups of healthy volunteers will receive 7 probe drugs     individually and as a combination of the 7 drugs given together as a cocktail. Part 2 will     assess the performance of the probe cocktail using three known inhibitors (validation). The     inhibitors plus probe cocktail will evaluate the ability of the newly established cocktail to     accurately quantify metabolizing enzyme or transporter inhibition, representing a fundamental     advance in probe cocktail validation and utility for drug development.   "
237309|NCT00964119|"     This is a prospective study, that will follow participants over their course of treatment on     Isotretinoin. All patients who are prescribed Isotretinoin for their acne treatment are     registered in iPLEDGE. The iPLEDGE program involves a set of steps that the patient,     physician and pharmacist must follow for the patient to take Isotretinoin. Patients will be     asked if they are willing to participate in this research study to determine musculoskeletal     changes in adolescents and young adults on systemic therapy using the highly sensitive     magnetic resonance (MR) imaging modality. In addition to the MRI, participants will be asked     if they are willing to give an extra sample of blood when their routine blood work is being     done for iPLEDGE. This blood sample will be used to determine if there are any effects of     isotretinoin on bone turnover markers.   "
237310|NCT00964132|"     The purpose of this study is to determine whether NRX 194204 is effective in the treatment of     advanced Non-Small Cell Lung Cancer (NSCLC).   "
237311|NCT00964145|"     The purpose of the study is to characterize the levator ani structures (pubovaginalis,     puboperinealis, puboanalis, puborectalis, and the iliococcygeous) using 3-D ultrasonography     in nulliparous women 21-70 years old.      Hypothesis 1: Prevalence of abnormalities in levator ani muscle structure will be associated     with increasing age independent of vaginal parity. To investigate the age-related symptoms of     pelvic floor dysfunction in nulliparous, women 21-70 years old.      Hypothesis 2: Anatomical abnormalities of the levator ani muscles will be associated with     symptomatic pelvic floor dysfunction. To investigate the age-related pelvic floor function in     nulliparous, women 21-70 years old.      Hypothesis 3: Age-related anatomical abnormalities of the levator ani muscles will be     associated with levator ani muscle weakness.   "
237312|NCT00964158|"     This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of     GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.   "
237313|NCT00964171|"     RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well efavirenz works as second-line therapy in     treating patients with metastatic pancreatic cancer.   "
237314|NCT00964184|"     This is a phase IV study of 3.5 years duration to evaluate the phenotypic and genetic     correlates of diabetes (non-Type 1 in young non-obese Asian Indians in North India and pilot     case control study to evaluate the efficacy of sitagliptin (DPP-4 inhibitor) in a sub-group     of the study population.   "
237315|NCT00964197|"     FemmeJock is a pelvic floor support system developed by pelvic floor physiotherapists for     patients with pelvic organ prolapse in order to ameliorate symptoms of pelvic floor pressure     and discomfort. The device is a girdle to be worn on the outside of underwear. The device is     machine washable and there are no documented risks with wearing it. This product is currently     being used by pelvic floor physiotherapists and has been subjectively reported by individual     accounts as being successful in improving pelvic floor symptoms. The efficacy of this product     has not been previously studied in women with pelvic organ prolapse. The investigators are     proposing a pilot study with the following specific aims:        1. to assess patient satisfaction and continuation of use of the FemmeJock support system          after 3 months of treatment.        2. to describe, if any, the reasons for discontinuation associated with the use of this          product, and        3. to assess whether women experience improvement of pelvic floor symptoms after using this          product.   "
237316|NCT00964210|"     A research project is currently being undertaken looking at Human Papilloma Virus (HPV)     vaccination in special risk groups. It aims to see if young women with a chronic illness     respond well to the HPV vaccine or whether they may require additional doses to ensure     protective immunity. The four valent HPV vaccine protects against HPV types 16 & 18, cervical     cancer and HPV types 6 & 11, anogenital warts.      The six special risk groups include:      Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia     Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow     Transplants This immunity is measured by antibody levels of the HPV types, which requires a     single blood test one month after the final dose of HPV vaccine.      This is compared to healthy controls using antibody response to HPV vaccine. This will assess     directly whether these special risk groups respond as well to the HPV vaccine.   "
237317|NCT00964223|"     Multi-center, single-blind, randomized, comparative, split-face study. The duration of the     study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and     benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion     (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3,     subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face     for an additional 6 weeks.   "
237318|NCT00964236|"     The objective of the study is to determine whether Kuvan™ (sapropterin) improves the strength     of the functional connectivity between brain regions in individuals with PKU.   "
237319|NCT00964249|"     This is a randomized, double blind, placebo controlled, parallel-group, 7 day repeat dose     study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of     inhaled dose of GW642444M from a novel dry powder device in healthy Japanese male subjects.   "
237320|NCT00964262|"     The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics     of SR exenatide (PT302) in healthy subjects.   "
237321|NCT00964275|"     RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography,     may help find and diagnose cancer. It is not yet known whether standard diagnostic procedures     are more effective when given with or without fludeoxyglucose F 18 positron emission     tomography in finding cancer.      PURPOSE: This randomized clinical trial is studying fludeoxyglucose F 18 positron emission     tomography given together with standard diagnostic procedures to see how well it works     compared with standard diagnostic procedures alone in finding cancer in patients with a blood     clot in a vein.   "
237322|NCT00964288|"     This study is being conducted to assess the effects of GSK1014802 and a positive control,     lidocaine, on tests of peripheral nerve excitability. This will be a double blind, placebo     controlled, 4-period cross over study. Approximately 20 subjects will be randomised to one of     two doses of a GSK1014802, lidocaine and placebo with at least 2 weeks between sessions. A     follow-up will occur 7-15 days after the last dose.      During treatment session 3 on the 6th October 2009, one subject had a pattern of AEs of     severe intensity, suggestive of brain stem toxicity / encephalopathy during the     lidocaine/saline infusion period. Although recognised in the literature when lidocaine was     used in patients for treatment of pain, these AEs were unusual in studies in healthy     subjects. The study was suspended to allow re-evaluation of the risk:benefit balance of     lidocaine/saline infusion in healthy subjects in this study. It was decided that continuation     of the use of lidocaine (positive control) would risk the safety of subjects. Continuation     without the positive control was not possible as it would compromise the scientific integrity     of the design.   "
237323|NCT00964301|"     The investigators will implement an interactive school-based telemedicine education program     for rural low-income, minority children with asthma, their caregivers, and school nurses in     the Delta region of Arkansas.      Specific aims:        1. The investigators will examine changes in asthma symptoms control and other health          outcomes such as activity levels and family/child emotional health in the intervention          group compared to a usual care group.        2. The investigators will examine changes in asthma knowledge, self-efficacy, and quality          of life in the intervention participants and their caregivers compared to a usual care          group.   "
237324|NCT00964314|"     The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM)     five elements music therapy improving quality of life for patients with advanced cancer, as     well as establishing the standard operating procedures (SOP) for it.   "
237325|NCT00964327|"     The purpose of this study is to determine the antiviral activity, safety and tolerability of     14 days of different doses of TMC114 to treat HIV-1 positive patients whose condition is     failing on a current treatment regimen that includes a protease inhibitor (PI) (a medication     used to reduce the amount of HIV virus in the blood).To be considered for the study, patients     must have a documented resistance to at least 2 of the current PIs. Pharmacokinetics and     pharmacodynamics of TMC114 will also be assessed.   "
237326|NCT00964340|"     The primary objective is to determine the pharmacokinetics, safety and tolerability of     SRT2104 in healthy elderly subjects following single and 28 days dosing.      The secondary objectives of the study are:        1. To contrast changes in leg muscle function following repeat doses of SRT2104 or placebo:           Endurance exercise tolerance 31P MRS measures of mitochondrial oxidative capacity in the          gastrocnemius muscle        2. To test for a change in the ratio of visceral to subcutaneous body fat following repeat          doses of SRT2104 relative to placebo using MRI        3. To estimate any changes in insulin sensitivity (using mOGTT) following repeat doses of          SRT2104 or placebo        4. To test for dose-related effects on the exploratory pharmacodynamic measures above   "
237327|NCT00964353|"     The purpose of this study is to explore how knowing genes that individuals inherit from their     parents can make warfarin dosing more safe and effective. This study is being done to     determine whether providing doctors with data on the genes their patients inherited and     warfarin dosing recommendations based on those genes affects the costs and outcomes of care     and after hospitalization for patients from different ethnic/racial backgrounds, and how     physicians use this information in decision making.   "
237328|NCT00964366|"     This is a randomized, half-face study. On 1 side of the face, the subject will apply 1 of the     2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side     of the face will remain non-treated to serve as a control.   "
237329|NCT00964379|"     This is a prospective randomized trial of intraperitoneal versus extraperitoneal techniques     for construction of terminal iliac fossa colostomies.   "
237330|NCT00964392|"     The purpose of this registry is to provide additional corroborative short-term safety and     long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters     in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).   "
237331|NCT00964405|"     This is a randomised, double blind, placebo-controlled, 2-parts study to investigate the     safety, tolerability, and pharmacokinetics of single and repeat inhaled doses of GSK233705     from a novel dry powder device in healthy Japanese male subjects.   "
237332|NCT00964418|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the blood     glucose lowering effect of NN1250 (insulin degludec) in young and elderly subjects with type     1 diabetes.   "
237337|NCT00964483|"     A diet that is rich in fruits, vegetables, and low fat dairy foods is known to lower blood     pressure in adults. This research project seeks to promote the adoption of the Dietary     Approaches to Stop Hypertension(DASH)eating pattern by African American adults with     hypertension or prehypertension living in a lower income minority community. The randomized     trial phase of this project will test a group-based intervention using materials adopted from     prior studies and tailored to the community of interest.   "
237338|NCT00964496|"     Background: Repeated episodes of bleeding from gastrointestinal vascular malformations     refractory to endoscopic or surgical therapy often pose a major therapeutic challenge.      Methods: The investigators performed a randomized, parallel controlled study of thalidomide     as a therapy for recurrent gastrointestinal bleeding due to vascular malformation. Patients     with at least six episodes of bleeding in the prior year due to vascular malformation were     randomly grouped, prescribed a four-month regimen of either 25 mg of thalidomide or 100 mg of     iron orally four times daily, and monitored for at least one year. The primary end point was     defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months and the     cessation of bleeding. Rebleeding was defined based on a positive fecal occult blood test     (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. Secondary     outcomes included the participants dependent on blood transfusions and changes from baseline     in transfused packed red cell units, bleeding episodes, bleeding durations, and hemoglobin     levels at 12 months. Statistical significance was defined at P < 0.05.   "
237339|NCT00964522|"     The purpose of this study is to evaluate the effects of a nurse education and care program     for patients with breast cancer, in terms of use of the health services, quality of life,     satisfaction and security.      Hypothesis:      Nurse education and care program will reduce the use of health resources and will improve the     toxicity, quality of life and satisfaction of the patients with breast cancer who initiate     chemotherapy.   "
237340|NCT00964535|"     The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with     the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.   "
237341|NCT00964548|"     Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the     brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain     arteries) is a known complication after SAH and significantly increases disability and death     after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown     that the muscles in the artery wall play a role in cVSP.      Dantrolene has been FDA approved and extensively used in clinical practice as a muscle     relaxant for more than 30 years. It has been shown to provide some benefit in animal studies     of cVSP, as well as in a small number of humans. Therefore, we plan to undertake this study     to evaluate the safety and tolerability of treatment with dantrolene in patients with cVSP     after SAH, and to determine the maximal tolerated dose to be used in future studies to     determine if treatment with Dantrolene can improve the outcome of patients with cVSP after     SAH.   "
237342|NCT00964561|"     The purpose of this study is to evaluate the safety and tolerability of short-term dosing of     IV ciprofloxacin when administered concomitantly with IV Valortim in healthy normal human     subjects.   "
237343|NCT00964574|"     Primary Objective:      To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM)     patients      Secondary Objective:      To evaluate the insulin glulisine doses To assess the patient satisfaction   "
237344|NCT00964587|"     The purpose of this study is to determine if patient education and problem-solving training,     delivered in self-study, group, and individual intervention modalities, will produce     substantial improvements in CVD risk profile via improved self management in urban African     Americans with type 2 diabetes and a high CVD risk profile.   "
237345|NCT00964600|"     The patients planned to go under elective cesarean delivery under general anesthesia are     randomly assigned to have either bilateral transversus abdominis plane (TAP) block or usual     standard analgesics after cesarean. Pain score (Verbal Analog Scale VAS) and analgesic     requirements are recorded. It's supposed that both are significantly reduced in patients     undergoing TAP block.   "
237346|NCT00964613|"     Cataract is a leading cause of Global blindness. After cataract surgery nearly half of the     people become blind due to posterior capsular opacification. The only solution for this     problem is LASER capsulotomy. Laser machine is not available in remote areas especially in     underdeveloped countries. The solution of this problem is surgical capsulotomy which can be     performed any where.   "
237347|NCT00964626|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving paclitaxel together with     cisplatin as first-line therapy and to see how well it works in treating patients with stage     I, stage II, stage III, or stage IV ovarian epithelial cancer.   "
237348|NCT00964639|"     This study is a comparison of postoperative pain in children with cerebral palsy after     surgery on the hip or femur. One group is treated with p.o. (by mouth) or intravenous (i.v.)     analgesia, and the other group is treated with local infiltration analgesia with Naropine.      Pain is measured with r-FLACC, a pain-score validated for children with cerebral palsy.   "
237349|NCT00964652|"     Background: Studies about the effects of walking training with additional body load in     Parkinson's disease (PD) are lacking. There is evidence that the increase of body load during     treadmill walking improves reflex activity and leg extensor muscle activity, which are     impaired in subjects with PD.      Purpose: The purpose of this study was to assess the effects of treadmill walking training     with additional body load on the ground reaction forces, spatiotemporal, and kinematic     variables of the gait of subjects with moderate PD.      Design: This study was an A1-B-A2 single-case. Setting: The evaluation and the training were     conducted in a movement analysis laboratory, and at the rehabilitation unit of the     University, respectively.      Participants: Nine patients with PD (Hoehn and Yahr 2 through 3) and gait disturbances.      Interventions: Phases A1 and A2 included 6 weeks of gait training on a treadmill with 10%     increase of normal body mass. Phase B included 6 weeks of conventional physical therapy.      Measurements: Measures included the ground reaction forces, spatiotemporal, and kinematic     variables during overground walking, at baseline and after each phase.   "
237350|NCT00964665|"     This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg     positivity. The study is designed to establish a dose response and safety relationship     sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also     designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements     in China.   "
237351|NCT00964678|"     The purpose of this study is to determine whether carvedilol treatment of patients with     pulmonary arterial hypertension and associated right heart failure is safe and results in an     improved function of the right heart.   "
237352|NCT00964691|"     The purpose of this study is to assess the effectiveness of intermittent preventive treatment     in pregnancy (IPTp) with Sulphadoxine-pyrimethamine compared to chloroquine prophylaxis in     Honiara, Solomon Islands for prevention of malaria and it's adverse effects in pregnancy.   "
237353|NCT00964704|"     This single arm, open-label study will evaluate the safety and efficacy of Herceptin in     combination with Avastin and sequential Xeloda in patients with locally recurrent or     metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy.     Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every     three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda     1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3     weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until     disease-progression on second line treatment and target sample size is <100.   "
237354|NCT00964717|"     This study aims to examine the efficacy of an Integrative approach utilizing Chiropractic as     an add-on therapy for the treatment back and neck pain in an emergency department setting      Chiropractic is well established as an effective treatment for back pain. The investigators     cumulative experience in Asaf Harofeh Medical Center has shown Chiropractic to be an     effective therapy for simple back and neck pain in an emergency room (ER) setting.      This study will examine weather Chiropractic can decrease pain, increase range of motion and     decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain     without neurological findings. Chiropractic will be performed as an add on therapy on top of     analgesic therapy.   "
237355|NCT00964730|"     The purpose of this study is to assess whether multiple doses of Talampanel increase the QT     interval when compared to placebo   "
237356|NCT00964743|"     The purpose of this study is to determine the tolerability and side effects of oral sorafenib     in combination with intrathecal DepoCyt.   "
237357|NCT00964756|"     In spite of surgical and chemotherapeutic advances, long term survival for advanced and     recurrent gynecologic cancers remains dismal and no curative treatment for recurrent disease     exists. Novel treatment strategies are needed. This is a study to determine the maximally     tolerated dose of and toxicities associated with intraperitoneal delivery of an infectivity     enhanced adenovirus that expresses a suicide gene and an gene that allows imaging of gene     transfer. This vector will be given in combination with intravenous ganciclovir in patients     with recurrent ovarian and other gynecological cancers.   "
237358|NCT00964769|"     The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure     the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA,     pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after     immunization (pneumococcal PS vaccine) in children, adults and elderly.   "
237359|NCT00964782|"     The study will test the hypothesis that a single dose of sildenafil can increase the exercise     capacity of pediatric patients with a Fontan Circulation.   "
237360|NCT00964795|"     The primary objective is to assess long-term safety and tolerability of Intravitreal     Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.   "
237361|NCT00964808|"     Effective treatment of pain after hip fractures is very important but difficult. It is often     an old patient who has many adverse effects with the use of morphine.      This is a randomized pilot study where the investigators want to compare Norspan plaster to     Oxycontin tablets to patients with particular kind of hip fractures. The investigators will     evaluate mobilization, pain, use of rescue medicine, adverse effects and length of stay. No     clinical study about the effect of Norspan as acute painkiller has never been done before.     Can the investigators get the patients mobilized earlier with less adverse effects?   "
237362|NCT00964821|"     RATIONALE: Studying immune response to flu vaccine in patients who have undergone a stem cell     transplant may help doctors plan the best treatment.      PURPOSE: This clinical trial is studying flu vaccine to see how well it works in preventing     infection in patients who have undergone a stem cell transplant and in healthy volunteers.   "
237363|NCT00964834|"     The purpose of this study is to evaluate the safety and tolerability of short-term dosing of     IV doxycycline when administered concomitantly with IV Valortim in normal healthy human     subjects.   "
237364|NCT00964847|"     The purpose of this study is to compare the effects of 24 weeks of either a blood pressure     education and walking program versus a yoga exercise program versus the combined intervention     of blood pressure education and yoga on reducing mild to moderate high blood pressure in     pre-hypertension and stage 1 hypertension subjects.   "
237365|NCT00964860|"     This is a randomized, controlled, examiner-blind, parallel group, four week clinical study     comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing     gingivitis.   "
237366|NCT00964873|"     An open-label phase 1 study to assess safety and efficacy of once-weekly STA-9090     (ganetespib) in subjects with AML, ALL and blast-phase CML.   "
237367|NCT00964886|"     This 12 week placebo controlled clinical trial tests the individual and combined effects of     an antidepressant medication and cognitive behavioral therapy for chronic back pain.   "
237368|NCT00964912|"     The purpose of this study is to determine the safety and tolerability of BMS-820836 after     single doses   "
237369|NCT00964938|"     The purpose of this study is to evaluate the effects of multisite left ventricular (LV)     biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the     effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be     superior to conventional BiV pacing.   "
237465|NCT00965419|"     The primary purpose of your child's participation in the study is to determine whether     LY2216684 can help pediatric patients with ADHD, and assess the safety of LY2216684 and any     side effects that might be associated with it.   "
237370|NCT00964951|"     The purpose of this study is to see how the body reacts to different strengths of the H1N1     flu shot when it is given with or without an adjuvant. An adjuvant is a substance that may     cause the body to produce more antibodies when it is given with a vaccine. This study will     also compare how age affects the body's response to the H1N1 flu shot. In this study, 3     strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2     strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the     same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will     include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250     individuals greater than or equal to age 65. Study procedures include: physical exam, blood     samples, completing a memory aid to record vaccine side effects, medications and daily oral     temperature. Participants will be involved in study related procedures for up to 13 months.   "
237371|NCT00964964|"     This trial is conducted in Europe. The aim is to compare changes in blood sugar and the     number of periods where carbohydrate supplementation is needed to treat low blood sugar,     during two different treatments with NN1250 (insulin degludec), a soluble insulin basal     analogue (SIBA) in subjects with type 1 diabetes.   "
237372|NCT00964977|"     Radiotherapy with or without adjuvant chemotherapy represents an important column of modern     therapy in advanced squamous cell originated tumours of the head and neck. However to date no     studies are available which study the effectiveness of radiotherapy in patients with resected     small tumours (T1, T2) and concomitant ipsilateral metastasis of a single lymph node (pN1)     for general treatment recommendation. The present study is designed as non-blinded,     prospective, multicenter randomized controlled trial (RCT) for comparison of overall-survival     as primary clinical target in patients receiving radiation therapy vs. patients without     adjuvant radiation following curative intended surgery. Aim of the study is to enroll 560     adult males and females for 1:1 randomization to one of the two treatment arms     (radiation/non-radiation. Secondary clinical endpoints are as follows: Incidence and time to     tumor relapse (locoregional relapse, lymph node involvement and metastatic spread), Quality     of life as reported by EORTC (QLQ-C30 with H&N 35 module) and time from operation to     orofacial rehabilitation.   "
237373|NCT00964990|"     The purpose of this study is to evaluate the safety and effectiveness of JNJ-42160443 in the     treatment of moderate to severe neuropathic pain in patients with a diagnosis of postherpetic     neuralgia and post-traumatic neuralgia.   "
237374|NCT00965003|"     To determine if high resolution MRI can detect early invasion of cartilage by laryngeal     carcinoma, and to determine if high resolution MRI may be superior to conventional MRI     imaging or CT imaging to detect cartilage invasion.   "
237375|NCT00965016|"     Background： Cardiopulmonary resuscitation (CPR) with closed-chest cardiac massage has been     shown that survival to discharge rate is poor. Attempt to increase success, some aggressive     methods such as extracorporeal membrane oxygenation (ECMO) has been used (also known as     extracorporeal cardiopulmonary resuscitation, ECPR). Otherwise, anoxic brain injury is     another issue after CPR. In recent years, some randomized prospective controlled trials of     induced hypothermia (IH) to 33℃ for 12 to 24 hours has been demonstrated to significantly     improve outcome in cardiac arrest patients. Because ECMO also could provide hypothermia     management, we plan this study to evaluate the cerebroprotective effect of ECPR with induced     hypothermia. We will try to analyze risk factors influencing patient survival and weaning     from ECPR and the optimal management for this ominous prognosis group.      Method:      The patients were recruited into the ECPR group only if they:        1. in cardiac arrest that necessitated external or open-chest cardiac massage and a large          amount of epinephrine (＞5 mg) during CPR.        2. Could not be returned to spontaneous circulation within 10 to 20 min. After ECPR, the          body temperature was started to be cooled down. Within 3 hours, the patients have been          well studied to search for potential reason of CPR. If the patients have no heart          problem or only intervention needed, they can be grouped into 1. Group 2 is the group,          which some further operation must be delivered. Group 3 is the group who cannot afford          to receive hypothermia (The physician in charge don't agree the trial.) In          ECMO-supported patients, two resulting comparisons were of concern: 1) ECMO weaning          versus nonweaning and 2) survival-to-discharge versus in-hospital death. We attempted to          identify the risk factors that affected weaning and survival, and we analyzed the effect          of ECPR with hypothermia on survival.      Expected result:      We will prove ECPR with hypothermia is a perfect strategy. And within three groups of the     patients, ECMO +induced hypothermia will be the most optimal choice.   "
237376|NCT00965029|"     Patients with COPD who deteriorate to Respiratory Failure pose a challenge to the intensivist     both in ventilating an obstructed patient and in weaning from mechanical ventilation.      Currently there are no accepted extubation criteria in COPD patients that could predict     successful weaning from mechanical ventilation. In this study we will attempt to correlate     spirometric data to eventual weaning from mechanical ventilation.   "
237377|NCT00965042|"     The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal     microflora in healthy volunteers.   "
237378|NCT00965055|"     Response to statin therapy for elevated low density lipoprotein is variable and may be     influenced by cholesterol absorption. This study will evaluate whether combination therapy     with atorvastatin/ezetimibe will be superior to atorvastatin alone in subjects who have less     than 25% LDL reduction on starting dose statin (eg, atorvastatin 10 mg daily or simvastatin     20 mg daily).   "
237379|NCT00965068|"     Background:      - Autism spectrum disorders (ASD) are developmental disabilities characterized by impaired     social interaction and repetitive and/or stereotypical behaviors. Research studies suggest     that some individuals with ASD have very low blood cholesterol levels. This low cholesterol     level and other abnormal sterol levels may be important markers for      subtypes of ASD. Providing additional cholesterol to the diets of children with ASD may help     improve behavior.      - These findings will guide the medical community in identifying individuals who should be     tested for sterol disorders. This study will also help researchers learn whether adding extra     cholesterol to the diet will improve behavioral and other autism spectrum characteristics     seen in individuals with ASD and low cholesterol.      Objectives:        -  To determine cholesterol levels in children with autism spectrum disorders.        -  To compare behavioral and other characteristics among children who have autism spectrum          disorders and high, low, or normal cholesterol levels.        -  To determine whether adding cholesterol to the diet will improve behavioral and other          characteristics in individuals with ASD and low cholesterol.      Eligibility:      - Children between the ages of 4 and 12 who have been diagnosed with an autism spectrum     disorder.      Design:        -  Initial screening study will involve a collection of blood samples (for study purposes          and cholesterol testing).        -  Children who have low cholesterol levels will take part in a study in which they will          receive either cholesterol supplementation or a placebo, and will have detailed physical          and psychological examinations to measure possible improvement in behavioral or other          characteristics.        -  Children who have high or normal cholesterol levels will have further blood samples          taken, and will undergo an additional set of examinations for comparison purposes.        -  Researchers may request blood or DNA samples from other family members (parents or          siblings), which will be collected through blood draws and cheek swabs.   "
237380|NCT00965081|"     The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is     effective in the treatment of fibromyalgia compared to placebo.   "
237381|NCT00965094|"     The primary objective of this trial is to show non-inferiority of a CNI-free regimen with     respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate -     Nankivell method - as compared to the standard CNI-based regimen in de novo renal transplant     patients.   "
237382|NCT00965107|"     This study is aimed at increasing the safety of the use of anaesthesia in an elderly     population (> 60 years). Patients with decreased physiological reserve, including all elderly     patients, have an increased risk of getting an erroneous induction bolus. This project will     investigate how fast elderly patients (> 60 years) fall asleep during bolus induction of     anaesthesia with two of the most used hypnotics, thiopental and propofol, evaluated with     BIS-monitoring and clinical signs of anaesthetic depth. The hemodynamic response will also be     evaluated.   "
237383|NCT00965120|"     Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the     heart. Current treatments are designed to relieve this blockage as quickly as possible to     minimize damage to the heart muscle. However in restoring the supply of blood local damage     known as ischaemia-reperfusion injury may occur. The aim of this study is to assess how     clot forming and clot dissolving pathways are affected during this process, and examine the     role of a natural inflammatory hormone, bradykinin. This will help the investigators to     understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new     treatments for heart attacks.   "
237384|NCT00965133|"     The hypotheses of the study are that children / youth with CP will by possibly use of     technical aids be able to perform high intensity endurance training by walking / running on a     treadmill, and that this training will improve their health by increased aerobic capacity and     quality of life.   "
237385|NCT00965146|"     The purpose of this study is to evaluate the design and functional performance of the     Scorpio® Cruciate Retaining (CR) Total Knee System.   "
237386|NCT00965172|"     The goal of this clinical research study is to find out if Caphosol® (calcium phosphate)     mouthwash is more effective than a baking soda solution at preventing and treating mucositis,     in patients with sarcoma who are to be treated with chemotherapy. The safety of this drug     will also be studied. Researchers also want to learn about the way calcium phosphate may     affect mucous membranes.      The goal of this clinical research study is to see if Caphosol® (calcium phosphate) mouthwash     is better than baking soda solution in patients with sarcoma who are to be treated with     chemotherapy . Caphosol will also be studied to see if it lessens the incidence and severity     of oral mucositis (painful sores in the mouth).   "
237387|NCT00965185|"     In HIV patients, statin therapy will attenuate plaque inflammation, thus, making plaques less     vulnerable, will deter plaque progression, and improve endothelial function. In addition to     known cholesterol-lowering and C-reactive protein lowering effects, immunomodulatory effects     of statins will lead to a shift from pro-inflammatory monocyte and T cell subsets to less     atherogenic subpopulations.   "
237388|NCT00965198|"     Intravenous catheters are placed in nearly every hospitalized patient. These catheters, since     they are breaks in skin integrity, are potential sources of infection that occur in the     bloodstream. Bloodstream infections can result in higher rates of death and lengths of     hospital stay, as well as increase healthcare costs. Blood is drawn or medications delivered     through a catheter access device attached to the catheter. In looking at new ways to decrease     infections associated with healthcare, the investigators plan to test whether the use of a     silver-coated catheter access device (VLINK) compared to the standard, non-coated device     (CLEARLINK) can reduce infection rates. These devices are identical in design other than the     silver coating of the VLINK, that imparts a brown color to the device. Silver can prevent the     growth of bacteria inside the device (biofilm formation) in the laboratory, but this has     never been proven in patients.      The investigators propose to do a crossover study in two Emory-owned hospitals (Emory     University Hospital and Emory University Hospital at Midtown), anticipated to last 10 months.     Currently, both types of devices, (standard and silver-coated) are FDA approved for clinical     use and are in use at both hospitals. The investigators plan to have each hospital use only     one type of catheter access device for a period of time (approximately 5 months), and then     switch (crossover) to other type of device for the rest of the study. All patients admitted     to either hospital (excluding newborns and patients with infections attributed to     hemodialysis catheters) will be enrolled since both devices meet the standard of care. During     the study, the infection prevention department, as a continuing part of their regular duties     will measure infection rates. A small subset of catheters that are removed during routine     clinical care (none will be taken out solely for the study) will be sent to CDC to determine     the amount of bacteria inside catheters and catheter access devices (look for biofilm).     Finally, the microbiology lab, again as part of its routine function will determine the rate     at which blood cultures are falsely positive. All of these measures will be compared using     statistical methods to see if there is a difference between the standard and silver-coated     catheter access devices.      In undertaking this study, the investigators will be using a type of vascular access device     (valve, not positive pressure) already in use in both hospitals and not changing the delivery     of care to patients while, in a rigorous, systematic manner, obtaining samples and data for     analysis.   "
237389|NCT00965211|"     This is an open study.approximately 20 patients diagnosed with tourette's syndrome and under     pharmAcological or psychotherapy treatments will participate.patients will be recruited from     Schneider hospital and all his extensions. subjects would undergo rTMS (repetitive     Transcranial Magnetic Stimulation) for five days a week, for four weeks,and will be     clinically evaluated in order to monitor for improvement.      We anticipate a significant reduction in symptoms severity at the end of the treatment     compared to study entry.   "
237390|NCT00965224|"     Dendritic cell therapy is a promising strategy for adjuvant cancer therapy in the setting of     minimal residual disease (MRD) to fight off cancer relapse and/or progression. The     investigators already performed a phase I safety study in leukemia patients that were in     complete remission demonstrating the absence of side effects and feasibility of the therapy.     Here, the investigators want to extend on this strategy by studying the clinical efficacy of     autologous DC vaccination in patients with acute and chronic myeloid leukemia and myeloma     patients. Effects of DC therapy on the immune reactivity towards leukemia cells as well as     clinical parameters such molecular MRD monitoring, time to relapse (TTR), progression-free     survival (PFS) and overall survival(OS) will be studied in vaccinated and non-vaccinated     (control) patients. Patients will be vaccinated using their own dendritic cells     electroporated with mRNA coding for the full-length Wilms' tumor antigen WT1.   "
237391|NCT00965237|"     The purpose of this study is to evaluate the use of a multifocal contact lens in people who     previously wore contact lenses but discontinued due to age-related, near vision demands.   "
237402|NCT00955344|"     The purpose of the study is to determine if a Web-based intervention increases physician     rates of colorectal cancer recommendation rates in a group of physicians participating in the     American Board of Internal Medicine's Maintenance of Certification Program. This study will     also compare the content of practice improvement plans submitted by the diplomats in each     study arm to determine the components of the plans that are associated with colorectal cancer     rates.   "
237403|NCT00955357|"     To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects     with uncontrolled partial-onset seizures after prior treatment with a monotherapy     Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at     least 2 AEDs.   "
237392|NCT00965250|"     Background:        -  Cisplatin-containing chemotherapy is the standard of care for advanced thymoma and          thymic carcinoma that cannot be treated with surgery. New options for treatment are          necessary in patients with advanced thymoma and thymic carcinoma that have progressed on          cisplatin-containing therapy.        -  IMC-A12 is a new (experimental) agent that has not yet been approved by the Food and          Drug Administration. IMC-A12 blocks the Insulin-like Growth Factor 1 receptor (IGF-1R).          IGF-1R is found on many types of cancer cells, including cancer of the thymus, and is          thought to play an important role in helping these cells to grow and divide.      Objectives:        -  To determine if IMC-A12 has an effect on tumor growth in patients with cancer of the          thymus.        -  To evaluate the safety and tolerability of IMC-A12 in treatment for cancer of the          thymus.      Eligibility:      - Individuals older than 18 years of age who have cancer of the thymus (thymoma, thymic     carcinoma, or thymic carcinoid tumors) that has progressed in spite of standard treatment.      Design:        -  Treatment will take place in 21-day cycles. Patients will receive one dose of IMC-A12          intravenously once every 3 weeks at the Clinical Center. During the Clinical Center          visits, researchers will perform study tests and procedures to see how the study drugs          are affecting the body.        -  Patients will undergo a number of tests and procedures during the treatment cycle,          including physical examinations, blood and urine samples for standard tests, imaging          studies (ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT) scans)          to evaluate tumor growth, and blood and urine samples to evaluate the amount of IMC-A12          in the body.        -  Patients may continue to take the drug as long as there are no adverse side effects and          as long as the tumor does not grow.   "
237393|NCT00965263|"     Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces     selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct     effects is unknown. The objective of this human laboratory study was to measure the     relationship between antibody titers and the effects of smoked cocaine on ratings of     intoxication, craving and cardiovascular effects.      Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks     inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and     at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.   "
237394|NCT00965276|"     This study will examine the relationship of a protein called pAKT to survival of breast     cancer patients with one or more positive axillary lymph nodes. Akt plays a role in cell     survival, tumor formation, and the development of drug resistance.      The study will use tumor tissue obtained from 2,000 patients enrolled in a National Surgical     Adjuvant Breast and Bowel Project study that is evaluating whether adding the drug paclitaxel     (Taxol (Registered Trademark)) to a treatment regimen of doxorubicin (Adriamycin (Registered     Trademark)) and cyclophosphamide (Cytoxan (Registered Trademark)) improves disease-free     survival and overall survival in patients with node-positive breast cancer. The current study     will measure levels of pAkt in the tissues and correlate the results with clinical outcome to     see if pAkt levels are associated with improved patient survival.   "
237395|NCT00965289|"     A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI,     up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like     regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who     achieved at least a PR, ASCT started with a BEAM regimen.   "
237396|NCT00965302|"     The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to     medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with     medical management, with a primary endpoint of diabetes remission (normal fasting glucose,     off medications and insulin) at one year. Sleeve gastrectomy (also called greater curvature     gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection     of the gastric fundus. Secondary endpoints include weight loss, improvement in hypertension,     sleep apnea, c-reactive protein, and fasting lipid profile.   "
237397|NCT00955266|"     Successful heart surgery requires the resumption of a strong beating heart prior to     separation from the heart and lung machine. There are different ways to do this. At this     hospital, the surgical team usually gives calcium to people when they come off of the heart     and lung machine because some doctors believe that calcium can jump start the heart. Not     every hospital does this.      Some people think that calcium may have a side effect of making the heart more stiff. Stiff     hearts do not beat as well or receive as much blood to tissues as non-stiff hearts. If     calcium makes the heart stiff, then doctors may have to use other medicines to support the     heart in the operating room and the intensive care unit. This may ultimately lead to poorer     outcomes including a longer stay in the intensive care unit and in the hospital.      This study is being performed to find out if calcium has the side effect of making the heart     more stiff. This study compares calcium to placebo. The placebo looks exactly like the     calcium, but it contains no calcium. During this study patients may receive placebo instead     of calcium. Neither the doctor nor the study team will know which drug the subject will     receive.   "
237398|NCT00955279|"     This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo     (placebo looks like the drugs being studied, but has no active ingredients). The purpose of     this research study is to determine if ustekinumab or golimumab is safe and to determine its     effects (good and bad) on patients with chronic sarcoidosis with pulmonary and/or skin     involvement. Patients with pulmonary involvement constitute the primary population for     analysis, and patients with skin involvement constitute the secondary population; a patient     may be in both populations. The study will be conducted at approximately 40 sites globally.   "
237399|NCT00955292|"     This phase 1 study of quarfloxin (CX-3543) is designed to test the safety, tolerability, and     highest safe dose of this drug when administered intravenously weekly for three weeks of a     four week cycle in patients with advanced solid tumors.   "
237400|NCT00955305|"     This randomized phase II trial studies how well carboplatin, paclitaxel, and bevacizumab     (CPB) work when given with or without cixutumumab in treating patients with non-small cell     lung cancer that is stage IV or has come back (recurrent). Drugs used in chemotherapy, such     as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of     tumor cells to grow and spread. Other types of monoclonal antibodies, such as cixutumumab,     may find tumor cells and help kill them. It is not yet known whether giving more than one     drug (combination chemotherapy) together with bevacizumab is more effective when given with     or without cixutumumab in treating patients with non-small cell lung cancer.   "
237401|NCT00955318|"     The purpose of this study is to evaluate the safety and efficacy of KW-6500 when administered     as long-term subcutaneous self-injections in Parkinson's disease patients with motor response     complications on levodopa therapy.   "
239964|NCT00989404|"     The purpose of this study is to compare the safety and tolerability of Zanamivir using a     Rotahaler device presentation to placebo within the Rotahaler presentation and to the     Diskhaler device.   "
237404|NCT00955370|"     Background:        -  Rare and undiagnosed conditions are often chronic and disabling, with symptoms affecting          different organ systems at various levels of severity. Perhaps the most challenging          feature of an undiagnosed medical condition that has lasted 2 or more years is its          characteristic uncertainty. In the absence of a diagnosis, health care professionals can          provide only limited treatment and prognostic information.        -  In the case of a child with an undiagnosed condition, the uncertainty that accompanies          what is often a chronic, debilitating medical condition and an undefined prognosis may          have physical, psychological, social, and spiritual implications for the entire family.          Research suggests that parents of a child with an undiagnosed medical condition may be          at significantly increased risk of anxiety, depression, poor health, and overall lower          quality of life.        -  It is not well understood how individuals cope with and adapt to chronic uncertainty,          and the factors that influence this process. To design future interventions, descriptive          studies are needed to reveal predictors that can be manipulated to improve outcomes.      Objectives:        -  To examine whether perceptions of uncertainty, and perceived personal control, are          associated with coping and adaptation.        -  To examine how the length of time elapsed since child was identified as sick and          perceptions of uncertainty affect coping and adaptation.        -  To assess how perceptions of uncertainty, time elapsed since child became sick,          optimism, and perceived personal control affect coping and adaptation.      Eligibility:        -  Parents (older than 18 years of age) of children who have an undiagnosed medical          condition.        -  Participants must have a working e-mail address or fixed postal address.      Design:        -  Parents will be recruited from Web-based support networks for parents of undiagnosed          children through Web site postings, electronic mailing lists, and printed newsletter          postings.        -  Participants will be asked to complete a questionnaire about their experiences in living          with a child who has an undiagnosed but chronic medical condition. The main outcome          variable is adaptation to living with one's child's undiagnosed medical condition.        -  Participants have the option to complete an online or paper version of the          questionnaire. The questionnaire should take between 20 and 30 minutes to complete.        -  No medical treatments are specifically offered as a part of this study.   "
237405|NCT00955383|"     GSK2190915 is currently in development for the treatment of asthma. This study aims to assess     the safety and tolerability of single doses of GSK2190915 in healthy Japanese subjects. The     study will also look at the pharmacokinetics (PK) and pharmacodynamics (PD) of single doses     of GSK2190915 and aims to characterise the PK/PD relationship in healthy Japanese subjects.     Twelve healthy Japanese subjects will take part in this single escalating dose study and     subjects will receive one of five possible treatments, 10 mg, 50 mg, 150 mg, 450 mg     GSK2190915 or placebo in each treatment period. Blood samples (for safety, pharmacokinetics     and pharmacodynamics), urine samples (for safety and pharmacodynamics) and ECGs, blood     pressure readings, physical examinations and a review of adverse events will take place at a     number of timepoints pre and post each dose. A minimum 7 day washout between treatment     periods will be required. Regardless if a subject completes or prematurely withdraws from the     study, a follow up visit will be completed 7-10 days following last dose.   "
237406|NCT00955396|"     In this study the investigators will determine whether there is any effect of GSK1014802 on     ambulatory blood pressure. This will be a randomized, double-blind, placebo-controlled,     repeat dose, 2 period cross-over study conducted in healthy male and female subjects.     Approximately 60 subjects will be randomised to receive GSK1014802 400 mg bid and placebo for     36 days with at least 1 week between treatment sessions. A follow-up will occur 7-14 days     after the last dose.   "
237407|NCT00955409|"     The purpose of this study is to assess the long term safety, tolerability, and immunogenicity     of ACC-001, an investigational active immunization product+, in subjects with mild to     moderate Alzheimer's disease.   "
237408|NCT00955422|"     Background:        -  Individuals who demonstrate symptoms of Alzheimer s disease, such as progressive memory          loss, may be eligible to participate in National Institutes of Health research studies.          However, other physical and psychological conditions may produce symptoms similar to          those of Alzheimer s disease. To determine whether a patient meets the eligibility          criteria to participate in a research protocol, researchers must perform a series of          diagnostic tests and procedures.        -  These evaluations are designed to evaluate a participant s general medical condition          (for example, blood tests and neurological exams) and to confirm a diagnosis or rule out          an individual for consideration. They maximize the safety for participants in studies          conducted at the National Institutes of Mental Health.      Objective:      - To determine the eligibility of individuals for active Alzheimer s disease protocols.      Eligibility:      - Individuals 45 years of age and older who have been having memory problems that have been     getting worse with time and have been interfering with everyday life.      Design:        -  Required tests and procedures for various research studies may include the following:        -  Medical history and physical examination, including a psychiatric evaluation.        -  Neuropsychological tests to test memory, mood, concentration, and thought processes.        -  Blood and urine tests.        -  Imaging studies (X-rays, magnetic resonance imaging (MRI), computerized tomography (CT),          positron emission tomography (PET)).        -  Additional blood samples and MRI data for future use.        -  After all eligibility assessments are complete, participants may be offered          participation in one or more research protocols   "
237409|NCT00955435|"     RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This clinical trial is studying blood and urine samples in patients with newly     diagnosed localized prostate cancer treated with hormone therapy and radiation therapy.   "
237410|NCT00955448|"     Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An anterior     wall prolapse occurs when the front of the vagina loses its support, and the bladder drops     down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina.      One of the treatment options available is to repair the anterior wall surgically. The goals     of surgery are to return the anatomy to its usual position, ensuring that all the pelvic     floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair     would also be long lasting.      Two surgical options are routinely performed in Calgary for repair of an anterior compartment     prolapse. One option involves fixing the organs back in place using sutures. The other option     uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for     use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The     investigators do not know which of these two options is the best surgical procedure. Both may     have different advantages that would result in better results. This study is designed to try     and find out if one of these procedures is better, and if a larger study may be needed.   "
237411|NCT00955461|"     The purpose of this study is to compare the results of treatment between the side of the face     treated with the RevLite Laser and the side of the face treated with a fractionated laser     system.   "
237412|NCT00955474|"     The purpose of this study is to compare the efficacy and tolerability of Seroquel monotherapy     for the treatment of Major Depression with Psychotic features with Seroquel plus Selective     Serotonin Reuptake Inhibitor.   "
237413|NCT00955487|"     Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns.     The condition involves abnormal development of lung tissue and is characterized by     inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce     the incidence of BPD and another commonly associated condition called pulmonary hypertension,     which is high blood pressure in the vessels carrying blood to the lungs.. This study will     determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary     hypertension, and death in premature newborns.   "
237414|NCT00955500|"     The purpose of this study is to compare a normal-protein diet containing branched-chain amino     acids to a low-protein diet in patients with non-terminal cirrhosis (MELD < 25) who have     developed an episode of hepatic encephalopathy within two months prior to inclusion.   "
237415|NCT00955513|"     The main purpose of this trial is to compare the efficacy and safety of diclofenac     diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in     the treatment of acute ankle sprains (distortions).   "
237416|NCT00955526|"     The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of     istradefylline for reducing the mean total hours of awake time per day spent in the OFF state     in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet     entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses     of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks     and will have interim visits and end of treatment visit to assess the efficacy and safety of     istradefylline.   "
237417|NCT00955539|"     30% of heart failure patients that receive a device for cardiac resynchronization therapy     fail to show clinical improvement. The reason for lack of response is still unclear but     factors such as scar tissue in the heart musculature, inadequate lead placement,     device-settings and the degree of dyssynchrony before implant seems to be important. In this     study, these factors are further investigated.   "
237418|NCT00955552|"     The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin     sulfate association in the treatment of patients with osteoarthrosis of the knee.   "
237419|NCT00955565|"     The purpose of this study is to compare the precision of computer-assisted navigation for hip     screw implantation to conventional fixation without navigation.   "
237420|NCT00955578|"     The investigators' goal is to identify the mutation in the gene that is responsible for the     development of segmental dysplastic nevi. To identify the gene the investigators may use a     candidate gene approach (i.e. sequence specific genes that are thought to be involved: NRAS,     BRAF, etc) or a genome-wide approach trying to implicate regions in the genome     (Loss-of-heterozygosity or copy number changes on comparative genomic hybridization).   "
237421|NCT00955591|"     RATIONALE: Doctors use a swab to collect cell samples when testing for anal cancer and human     papillomavirus. It is not yet known which type of swab is more effective in collecting cell     samples for anal Pap tests and human papillomavirus tests in men who have sex with men.      PURPOSE: This clinical trial is comparing two types of swabs in collecting cell samples for     anal Pap tests and human papillomavirus tests in men who have sex with men.   "
237422|NCT00955604|"     To identify the occurrence of serotonin toxicity in Parkinson's Disease (PD) patients     receiving antidepressant therapy and rasagiline, compared to those receiving rasagiline     without antidepressant medications and compared to PD patients receiving antidepressants, but     not rasagiline.   "
237423|NCT00955617|"     This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced     MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.   "
237424|NCT00955630|"     The purpose of this study is to evaluate the safety and effectiveness of intravitreal     ranibizumab (Lucentis) in patients with fluid and blood leakage in their eyes due to ocular     histoplasmosis.   "
237425|NCT00955643|"     Evaluation of the clinical effect of hyperbaric oxygen therapy (HBOT) adjunctively to scaling     and root planing (SRP) in the treatment of severe case of chronic periodontitis.   "
237426|NCT00955656|"     The proposed study will utilize a survey format to examine the attitudes, perceptions, and     practices of primary care providers in the Delta region of Arkansas.   "
237427|NCT00955669|"     Objective:      To compare the effect and safety of autologous transplantation of bone marrow mesenchymal     stem cells(MSCs) and mononuclear cells(MNCs) on Diabetic patients with Critical Limb Ischemia     and Foot Ulcer.      Methods:      patients were randomized into the A group and the B group by use of a randomization table.     One lower limb in A group or in B group was selected randomly for MSCs or MNCs     transplantation as MSCs or MNCs group, the other lower limb in the same patient was selected     for placebo（normal saline ,NS）injection as NS group.      The whole procedures of this clinical trial were blinded to both patients and     investigators.Patients in both groups received the same ordinary treatment. Meanwhile, MSCs     and MNCs were transplanted into the impaired lower limbs respectively. Follow-up index     include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial     index,Transcutaneous oxygen pressure,magnetic resonance angiography) and safety (infection of     the injection site, immunological rejection, and tumour generation).   "
237428|NCT00955682|"     Subjects were previously vaccinated at 12 to 23 months of age. This extension study starts 24     months after vaccination and the subjects who were vaccinated in the primary study will be     enrolled in this extension phase. No new subjects will be enrolled.   "
237429|NCT00955695|"     RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in     patients with advanced non-small cell lung cancer. It is not yet known whether radiation     therapy is more effective than observation in patients with advanced non-small cell lung     cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see     how well it works compared with observation in preventing brain metastases in patients with     advanced non-small cell lung cancer.   "
237430|NCT00955708|"     The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term     performance of the ACUITY Spiral Left Ventricular Lead.   "
237466|NCT00965432|"     The objectives of this study are to determine the safety and tolerability of single oral     doses of STX107 and to determine basic pharmacokinetic (PK) parameters following single oral     doses of STX107 when administered via an oral suspension   "
237431|NCT00955721|"     The purpose of this study is to build on the efficacy of the GEMOX regimen by adding     Sorafenib in the treatment of Biliary Tract Cancer. Since there is no data on the combination     of these three agents, the investigators plan to evaluate the safety in a run-in phase I     portion in order to define the recommended phase II dose (RPTD). The phase II trial will     enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary     estimate of progression-free survival (primary endpoint of the trial) in the target     population.   "
237432|NCT00955734|"     Many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist     motion. Early motion is generally prescribed in the belief that it will result in greater     final motion without compromising fixation. However, studies have failed to demonstrate     clinically significant improvement in final wrist motion (> 1 year follow up) compared to     treatments requiring longer immobilization such as external fixation or bridge plating.   "
237433|NCT00955747|"     The purpose of this trial was to evaluate the effectiveness and safety of Naturlose     (Tagatose) for glycemic control in people with Type 2 diabetes who were not taking other     medications for the condition and who were under diet control and exercise.      The study lasted approximately one year. HbA1c was monitored every 2 months after entry into     the study. Safety and tolerance for tagatose were assessed every 2 months throughout the     study. A total of 14 visits were made to the study site.   "
237434|NCT00955760|"     Primary Objectives:      • Assess the effects of poly-specific cytochrome P450 and drug-transporter induction by     repeated dose Rifampicin (600 mg/day) co-administration on the single-dose pharmacokinetics     of Neramexane.      Secondary Objectives:      • To assess safety and tolerability of Neramexane single dose treatment alone and     co-administration of a Neramexane single dose with a Rifampicin repeated dose treatment.   "
237435|NCT00955773|"     The purpose of this study is to determine the recommended dose and regimen for the orally     administered MEK inhibitor GSK1120212 dosed in combination with everolimus in subjects with     solid tumors. The escalation part of the study will determine the MTD. The combination will     be further explored in the expansion part in subjects with metastatic pancreatic cancer. In     addition, subjects with KRAS mutant non-small cell lung cancer will be enrolled.   "
237436|NCT00955786|"     This phase 1 study of CX-3543 is designed to test the safety, tolerability and highest safe     dose level of this drug in patients with advanced solid tumor cancers.   "
237437|NCT00955799|"     The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in     the treatment of subjective tinnitus in comparison to placebo.   "
237438|NCT00955812|"     The goal of this clinical research study is to find the highest tolerable dose of OPB-31121     that can be given to patients with an advanced solid tumor. The safety of this drug will also     be studied.   "
237439|NCT00955825|"     The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of     grass pollen allergen extract compared to placebo in adult patient with allergic     rhinoconjunctivitis.   "
237440|NCT00955838|"     The trial aims to test a novel rehabilitation device for subacute stroke hemiplegic upper     limbs based on state-of-the-art non invasive Brain-Computer Interface (BCI) robotic     rehabilitation in a clinical setting. The investigators aim to prove the clinical efficacy     and safety of BCI therapy over traditional rehabilitation methods.   "
237441|NCT00955851|"     Investigators in the Division of Infectious Diseases and the Division of Hospital Medicine of     The George Washington University Medical Center are carrying out a study to determine if     hospitalized patients receiving the polyvalent pneumococcal vaccine during an acute illness     develop an adequate antibody response. The study group will consist of individuals diagnosed     with pneumonia and admitted to the Medicine ward under the Pneumonia Core Measure Protocol,     which assigns appropriate patients for vaccination based on the current guidelines from the     Advisory Committee on Immunization Practices (ACIP).   "
237442|NCT00955864|"     Background:        -  The uterine cervix is composed of muscle and collagen, which change as women age and          under hormonal influences like puberty, pregnancy, and menopause. Yet even though          knowledge of structure of the cervix (especially the collagen network) is important to          detect problems that may affect pregnancy and other women s health issues, no          noninvasive techniques are available to evaluate such changes.        -  A specially designed polarized camera attached to a conventional colposcope can be used          to take cervical images. Analyzing these images may enable researchers to better          visualize the collagen network in the cervix.      Objectives:        -  To explore and gain experience with the use of a polarized imaging system to study          cervical structure.        -  To evaluate the usefulness of a polarized imaging system in studying the cervical          structure of healthy nonpregnant women.      Eligibility:      - Adult females (at least 18 years of age) who are having regular menstrual cycles and are     not on hormonal medications.      Design:        -  Images will be takes from the cervix in two different phases of menstruation cycle time,          one in the follicular phase (before ovulation) and another one in the luteal phase          (after ovulation).        -  The images of the cervix will be taken with a vaginal speculum in place with the camera          attached to a colposcope. The colposcope will illuminate the cervix using polarized          light. Three random cervical locations will be photographed   "
237455|NCT00956033|"     Neuropathy is a common side effect of chemotherapeutics used for the treatment of multiple     myeloma, including vincristine, thalidomide and bortezomib. The neuropathy induced by these     drugs is often preferentially small fiber. Small fiber neuropathies are difficult to diagnose     and quantify using conventional electromyography. Determining intra-epidermal nerve fiber     density (IENFD) in skin biopsies from diabetes and AIDS patients has been shown to be a more     sensitive and more specific ancillary investigation to establish the diagnosis of small fiber     neuropathy. In this study the investigators aim to establish the sensitivity of IENFD     measurements in skin biopsies from patients with multiple myeloma treated with bortezomib.   "
237478|NCT00965588|"     The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the     amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients     diagnosed with mild or moderate Alzheimer's disease (AD). Amyloid beta was selected as the     target antigen based on supporting evidence of the hypothesis that places the accumulation of     amyloid beta at the initiating step of AD.   "
237443|NCT00955877|"     The purpose of this proposal is to improve the investigators' current Selective Dorsal     Rhizotomy (SDR) analgesia protocol by eliminating or minimizing the use of fentanyl in the     post-operative period.      Children undergoing SDR for spastic cerebral palsy have significant post-operative pain. The     procedure requires dissection of the lumbar back musculature and removal of the L1 lamina     (the bony posterior part of the vertebra). The majority of the operation is intradural, and a     water-tight dural closure at the termination of the operation is critical in order to prevent     leakage of cerebrospinal fluid (CSF) from the wound. In fact, these children must remain flat     on their back for 48 hours to allow the dural incision to heal prior to mobilization. Thus,     adequate pain control is essential not only for patient comfort, but also to prevent     agitation and additional stress on the dural closure.      Currently, the investigators' patients undergoing SDR are treated for 48 hours with scheduled     intravenous (IV) narcotic (continuous fentanyl infusion at 0.5-2.0 μg/kg/hour) in addition to     the sedative/muscle relaxant Valium (0.2 mg/kg IV every 4 hours for 24 hours, then every 6     hours for 24 hours). The IV fentanyl, and to a lesser degree Valium, carries a real risk of     hypotension and respiratory depression and requires frequent dose adjustments to achieve     adequate analgesia.      By improving the current SDR analgesia protocol, the investigators hope to maximize patient     safety and comfort while maintaining the effectiveness of the operation by minimizing the     risk of CSF leak.   "
237444|NCT00955890|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the     side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor     cells and either kill them or deliver tumor-killing substances to them without harming normal     cells. Radiation therapy uses high-energy x-rays to damage tumor cells. CTnT/cTnI/ANP/BNP     were proved to be used as a biomarker of drug related cardiotoxicity. There are excellent     correlations between the total cumulative dose of doxorubicin, the severity of the resulting     cardiomyopathy, and the level of serum troponin-T.   "
237445|NCT00955903|"     The investigators want to determine if the benefits of weight loss outweigh the potential     risk in a group of older adults. The investigators will test the hypothesis that changes in     diet composition alone or in conjunction with weight loss will have a significant effect on     fat stores, and as a result, improve cardiometabolic risk factors and functional status in     adults 65 and older.   "
237446|NCT00955916|"     The purpose of the study is to find out what effects (good and bad) Gleevec® (Imatinib     mesylate) combined with chemotherapy has on participants and their acute myeloid leukemia.   "
237447|NCT00955929|"     When a bilateral nerve-sparing radical prostatectomy (RP) is performed, recovery of erectile     function (rigid erections) is reported for up to 80% of patients, who are less than 60 years     old. Erectile function recovery is also impacted by patient age, erectile function before     surgery, and the length of time after surgery.      Current evidence from studies suggests that developing erections is important, however, these     studies have been small, and the evidence is not definite. Animal studies suggest that     erection medication (Viagra, Levitra, Cialis) may protect erection tissue, even in the     absence of erections. However, the correct treatment plan is unknown. For example, how often     does a man need to take sildenafil (Viagra®) to protect his erectile function or to maximize     his erectile function recovery? Is only using erection medication enough for erectile     function recovery? Would penile injections, which almost ensure production of an erection, be     better than using sildenafil (Viagra®), or might a combination be even better at helping     recovery of erections? These are types of questions this study might answer.   "
237448|NCT00955942|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Flaxseed may help     protect normal cells from the side effects of radiation therapy.      PURPOSE: This randomized phase I trial is studying the side effects of flaxseed supplement in     treating patients with locally advanced or metastatic non-small cell lung cancer undergoing     chemotherapy and radiation therapy.   "
237449|NCT00955955|"     The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin) is safe and effective     in relieving depression when it is added to standard kinds of antidepressants called     serotonin reuptake inhibitors (SSRIs).   "
237450|NCT00955968|"     This study is a randomized strategy trial conducted among women who received highly active     antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child     transmission (PMTCT) of HIV but do not otherwise meet criteria to initiate HAART for their     own health. The study is designed to determine whether continuation of HAART after delivery     or other pregnancy outcome reduces morbidity and mortality compared to discontinuation and     re-initiation of HAART according to current standards of care.   "
237451|NCT00955981|"     To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28     days of dosing by treatment group.   "
237452|NCT00955994|"     The treatment of acute pain in patients with irritable bowel symptoms is suboptimal. This is     a placebo controlled study of the on demand treatment of pain experienced over a 4 week     period in patients with irritable bowel syndrome. Patients will record the severity of pain     when they take the study medication and two hours later.   "
237453|NCT00956007|"     RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to     help focus thin beams of radiation directly on the tumor, and giving radiation therapy in     higher doses over a shorter period of time, may kill more tumor cells and have fewer side     effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. It is not yet known whether radiation     therapy is more effective when given alone or together with cetuximab in treating patients     with head and neck cancer that has been removed by surgery.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works compared with radiation therapy given together with cetuximab in treating patients who     have undergone surgery for locally advanced head and neck cancer.   "
237454|NCT00956020|"     Autologous platelet rich fibrin matrix will release growth factors which could increase the     production of dermal proteins or affect the vascularity and status of neighboring tissues.     This study is designed to evaluate the histologic and biochemical effect of injection of     platelet rich fibrin matrix into the skin.   "
237456|NCT00956046|"     The purpose of this study is to generate data on immunogenicity and safety of the monovalent     H1N1 vaccine in support of the development and registration.      Primary objectives:        -  To describe the immune response to vaccines 21 days after each vaccination in all          participants.        -  To describe the antibody persistence eight months after the first vaccine administration          using hemagglutination inhibition (HAI) method in a subset of participants who received          two half-doses of either formulation 1 or 2.        -  To describe the immune response against the A/H1N1 strain using the HAI method 21 days          after last vaccination with the 2010-2011 NH seasonal Trivalent Influenza Vaccine (TIV)          administered 13 months after the first vaccination in a subset of subjects who received          two half-doses of either t either formulation 1 or 2 of the A/H1N1 influenza vaccines as          primary series.        -  To describe the safety profile of each vaccine in all participants.   "
237457|NCT00965315|"     Diabetic patients have an excess risk of mortality due to cardiovascular diseases (CVD)     compared to non-diabetics. Cardiovascular disease mortality rate is reportedly on the rise in     several countries in the region, including urban China, Malaysia, Korea and Taiwan.     Cardiovascular diseases and stroke are always the number 2 and 3 killers for Taiwanese     population in recent years, and they really cost much from our medical resource. For treating     dyslipidemia, one of the major risk factor for CVD, statins have been well documented to     reduce CV deaths both for primary and secondary prevention in several large-scale trials. It     has been reported that the clinical benefits of treating dyslipidemia in patients with     diabetes mellitus should be at least equivalent to the benefits observed among those with     cardiovascular disease. A meta-analysis of seven trials of statins found that treatment for     about 5 years resulted in a 25% reduction in the combined outcome of coronary heart disease     death and non-fatal myocardial infarction. Fibrates are another group of hypolipidemic drugs     that regulate lipid metabolism and are used quite often in daily practice for diabetic     dyslipidemia, because of its beneficial effect to reduce high TG and increase low HDL-C,     which are the characteristic lipid abnormalities commonly seen in the patients with diabetes     or metabolic syndrome. However, in recently published FIELD study, fenofibrate did not     significantly reduce the risk of the primary outcome of coronary events in 9,795 participants     with type 2 diabetes mellitus. The higher rate of starting statin therapy in patients     allocated placebo might have masked a moderately larger treatment benefit. Furthermore, all     the treatment trials to back up the lipid treatment guideline were conducted in Caucasians     and no data about the combination therapy with fibrate and statin was published before.   "
237458|NCT00965328|"     The low molecular weight heparin nadroparin is used for anticoagulation of the extracorporeal     hemofiltration circuit. Continuous hemofiltration is a renal replacement modality for     intensive care patients with acute renal failure. Up to now it is not known whether     nadroparin is removed by hemofiltration or not. Accumulation would increase the risk of     bleeding.      Aim of the present study is to determine        1. whether nadroparin accumulates in plasma        2. whether nadroparin is removed by filtration and whether removal depends on          hemofiltration dose        3. the effects of nadroparin during critical illness on coagulation and anticoagulation   "
237459|NCT00965341|"     The goal of this clinical research study is to learn if and how testosterone replacement     therapy may affect fatigue in males with advanced cancer and low testosterone levels.   "
237460|NCT00965354|"     Influenza A is one of the best studied viruses, but continues to have a very large impact on     human and animal health. In addition to causing outbreaks of winter flu, it sometimes mutates     to create a new virus that spreads quickly around the world. It is puzzling that the same     virus appears to cause minor or absent symptoms in some people while killing others. Much     remains to be understood.      We have assembled an unprecedented group of internationally renowned scientists from England     and Scotland who will together focus on studying a few hundred people hospitalised during the     current swine flu pandemic. Such a largescale project has never before been attempted, but we     are now poised to work together and integrate the many recent advances in biomedical science     that relate to understanding how influenza causes disease.      The ultimate goal of this collaborative, intensive study is to discover new and effective     treatments and to develop better vaccines that can be used in future outbreaks. By     integrating the information that we will gather, we will create a unique overview of how     influenza causes illness and what might be done to improve patient management.   "
237461|NCT00965367|"     Postoperative nausea and vomiting (PONV) remain a significant challenge in the investigators     practice. However, pharmaceutical prophylaxis can imply unpleasant adverse effects. It would     therefore be appropriate to consider the use of non-pharmacological methods in preventing     PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV,     and the adverse effects are minimal.      Consequently, the investigators will investigate if acupuncture and acupressure can be     implemented as a supplementary to the ordinary treatment in children undergoing surgery for     tonsillectomy and/or adenoidectomy. The study will also focus on the feasibility for     acupuncture and acupressure in the operation theatre. The study and inclusion/exclusion     decisions are conducted after the intention-to-treat principle. 126 patients are included,     divided into two groups:        1. Treatment Group - standard treatment and acupuncture performed after induction of          anaesthesia, acupressure administered before awakening        2. Control Group - standard treatment      The primarily endpoints in this study are nausea, retching and vomiting. The effect of     acupuncture/acupressure will be studied with regard to any association with possible factors     of predisposition to PONV, as well as with other factors registered during the study. Adverse     effects from the acupuncture site and wristband will be registered.   "
237462|NCT00965380|"     The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody     spacer and supplemental posterior fixation of the surgeon's choice and to follow the patients     to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that     Trinity Evolution combined with an interbody spacer and supplemental posterior fixation will     result in fusion rates and clinical outcomes similar to those with other routinely used     autograft and allograft materials including: fusion, improvement in pain and function,     maintenance of lower extremity neurological function, and absence of serious adverse events     related to the use of the Trinity Evolution product.   "
237463|NCT00965393|"     Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the     heart. Current treatments are designed at relieving this blockage as quickly as possible to     minimize damage to the heart muscle. However in restoring the supply of blood local damage     known as ischaemia-reperfusion injury may occur. The aim of this study is to assess how     clot forming and clot dissolving pathways are affected during this process, and examine the     role of a natural inflammatory hormone, bradykinin. This will help the investigators to     understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new     treatments for heart attacks.   "
237467|NCT00965445|"     Oxidative stress is an unavoidable event during cardiac surgery. Isoprostanes have been     demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.The     aims of this study are(1)to develop an accurate liquid chromatography-tandem mass     spectrometry methods for the detection of urinary isoprostane isomers in samples collected     from healthy volunteers(for method quality control) and patients receiving a cardiac surgery     (2)to investigate the change of isoprostanes after cardiopulmonary bypass(CPB) (3)to     investigate the effect of different anesthetics on isoprostanes.   "
237468|NCT00965458|"     The purpose of this trial is to test whether a drug called alefacept will slow or halt     destruction of the beta cells in the pancreas. If the destruction of the beta cells is     stopped, the patients might be able to produce insulin on their own longer, which could stop     or slow the progression of their type 1 diabetes.      This is a multi-center prospective, placebo-controlled, double-blind and randomized trial to     investigate the ability of alefacept to protect residual beta cells from ongoing autoimmune     destruction in adolescents and young adults with newly diagnosed Type 1 Diabetes Mellitus     (T1DM).   "
237469|NCT00965471|"     The purpose of this study is to built the standard of Chinese Traditional Medicine test for     Post percutaneous coronary artery intervention and coronary artery bypass graft，also for     acute coronary syndrome，according to the multi－site、random large sample test.   "
237470|NCT00965484|"     Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and     preference of Genotropin injection pen. Patients already on genotropin will be asked to use a     genotropin pen for 2 months. Patient and caregiver will be asked to complete a questionnaire     at baseline and 2 months.   "
237471|NCT00965497|"     The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major     depressive disorder in patients who have ALS or MS.   "
237472|NCT00965510|"     The purpose of this study is to determine whether it is possible to improve health outcomes     for patients with Type II diabetes, a community-based health care agency will offer care     coordination to half of a study group in a family practice office. The intervention will     include assessing patients' status using two instruments:      a depression screen (the PHQ9) and a motivation to change scale (the Patient Activation     Measure, PAM). A masters-level social worker will counsel patients in the intervention group.     Changes in patients' health status, PHQ9 scores and PAM scores over one year will be     measured. Outcomes will be compared between the study group and the group without     intervention.   "
237473|NCT00965523|"     The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate     the safety of patients who continue to receive E7389 after completing the Phase II clinical     study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed     breast cancer by intravenously administering E7389.   "
237474|NCT00965536|"     The general aim of this non interventional study is to clarify what are the current clinical     treatment practices of Quetiapine Immediate Release and Quetiapine Extended Release. The     primary objectives of the study are:1.To collect information on the used Quetiapine Immediate     Release or Quetiapine Extended Release medication 2.To collect information on duration and     number of hospitalisation days 3.Change of GAF points   "
237475|NCT00965549|"     The primary objective is to demonstrate the non-inferiority at six months of a basal plus one     insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin     regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes.      The secondary objective are:        -  To compare the proportion of patients in each treatment group reaching HbA1c target (<          7%) at the end of the treatment period        -  To compare the rates of hypoglycaemia (total, severe, nocturnal)        -  To compare the change in body weight from visit 10 to visit 24        -  To compare the change in diabetes specific quality of life and other patient reported          outcomes from visit 10 to visit 24             -  Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c)             -  Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire             -  Insulin Treatment Satisfaction Questionnaire (ITSQ)             -  EuroQoL 5 Dimensions (EQ5D) questionnaire        -  To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10          to visit 24   "
237476|NCT00965562|"     The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in     the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo     control. Third, to evaluate the efficacy of each treatment for specific symptom clusters     (i.e. affective and somatic). Fourth, to determine whether the addition of calcium to on     going fluoxetine treatment leads to additional therapeutic benefit.   "
237477|NCT00965575|"     The prevalence of epilepsy is 1% in the USA. About 30% of epilepsy patients eventually become     refractory to medical treatment. Co morbid conditions are becoming as important as seizure     control as these affect overall wellbeing. Sleep related complaints are frequent in them     including, frequent arousals, difficulty falling asleep and excessive daytime sleepiness.     Polysomnography shows increased arousal index, sleep onset latency, and stage shifts and     fragmented REM sleep. Poor sleep efficiency causes daytime fatigue, poor cognition and     behavior and can worsen seizure control. Stabilizing sleep may improve seizure control.     Melatonin is a naturally occurring hormone in the body involved in the regulation of     circadian rhythm and exogenously given, has been shown to decrease sleep onset latency,     arousals, and there-by increase sleep efficiency in healthy pediatric patients. Similar data     does not exist in the patients with epilepsy. As sleep has important impact on epilepsy and     overall functioning, it is important to study effect of melatonin in children with epilepsy.      We propose a randomized double blind placebo controlled trial with a cross-over design. Our     hypothesis is that, for patients with epilepsy, administration of melatonin 30 minutes before     bedtime for four weeks may:        -  Improve the quality of sleep;        -  Improve daytime functioning in terms of cognition, behavior and quality of life;        -  Decrease epileptic potential. We will use polysomnography, electroencephalogram,          psychomotor vigilance task, seizure diary, and questionnaires to assess the effect of          melatonin on these domains. This study may help to improve the care of children with          epilepsy.   "
237530|NCT00966485|"     The investigators prospectively studied the effect of aspirin on platelet function in 106     stable outpatients 6 months after successful percutaneous coronary angioplasty. Participants     were randomized in a double-blind, double-crossover study (80 or 500 mg per day for 6     months).T   "
237479|NCT00965601|"     The investigators are doing this study to better understand the role of the central nervous     system in processing painful stimuli in patients with fibromyalgia. Specifically, the     investigators would like to know whether the central nervous system processing of painful     stimuli changes with time and with talk therapy. In addition, the investigators are     investigating how changes in your fibromyalgia symptoms may affect certain markers or     proteins in your blood.   "
237480|NCT00965614|"     ECG is one of the most important non-invasive method to diagnose CAD and arrhythmia. However,     clinically it still has its limitation. Because the electrical field could induce a magnetic     field, the newly developed non-contact technique, magnetocardiography, was established to     detect the local magnetic field component of the heart. It is safe and more convenient. In     this study, we try to define and validate the magnetocardiographic patterns in the patients     with cardiac arrhythmias or ischemia.   "
237481|NCT00965627|"     This is a retrospective analysis of biological characteristics of thymoma and thymic     carcinoma patients.   "
237482|NCT00965640|"     This proof of concept study seeks to demonstrate that Botulinum toxin injections are a safe     and effective method for treating this form of hair loss.   "
237483|NCT00965874|"     Objective:      To assess the efficacy and the safety of high (9g) and low dose (4.5g) of MgS in the     immediate treatment of rapid AF.   "
237484|NCT00965887|"     This study will evaluate the bioequivalence of two solid dose formulations of MK0974.   "
237485|NCT00965900|"     This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL     combined with propranolol in patients with medium or large varices.   "
237486|NCT00965913|"     An investigation on the cumulative skin irritation potential of a newly developed 15 mg     nicotine patch. Evaluation of skin irritation of a newly developed 15 mg nicotine transdermal     patch.   "
237487|NCT00965926|"     The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of     YM178 in healthy, non-elderly adult subjects.   "
237488|NCT00965939|"     CYPTAM-BRUT 2 is a prospective, multicentric study including postmenopausal women receiving     tamoxifen for metastatic, locally advanced (stage IIIB/C) or in the neoadjuvant setting for     measurable estrogen-receptor positive breast cancers. The primary endpoint is the difference     in efficacy of tamoxifen, defined as the objective response rate using RECIST criteria,     between women with a normal versus low Tamoxifen Activity Score (TAS) after 3-6 months of     tamoxifen use. The TAS score is based on the presence of genetic variations and drug     interactions. Secondary endpoints are time to progression, clinical benefit, serum metabolite     concentrations, endometrial changes and menopausal symptoms. Patients using tamoxifen in the     neoadjuvant setting needs being operated between 4-6 months following the start of tamoxifen.   "
237489|NCT00965952|"     The purpose of this pilot study is to perform a procedure to evaluate the safety of the     placement of a new device (known as the VFIX device).   "
237490|NCT00965965|"     The purpose of this study is to determine whether a newly developed patient education     document concerning colorectal cancer screening will be better understood and have greater     effects on patient knowledge of and motivation for screening than a standard educational     document.   "
237491|NCT00965978|"     The aim of the study is to evaluate the effects of food intake on the plasma concentration     profile of YNO-5920/YM529 in post menopausal women.   "
237492|NCT00965991|"     Our hypothesis is that metformin and glyburide will have equal efficacy in controlling blood     glucose in gestational diabetics with no increase in adverse maternal, fetal or neonatal     outcomes.   "
237493|NCT00966004|"     The purpose of the study is to evaluate the effect of YM178 in patients with overactive     bladder for 12-week administration.   "
237494|NCT00966017|"     The purpose of this study is to develop small molecule radio-labeled probes of beta-amyloid,     to be used with positron emission tomography (PET) for early detection and treatment     monitoring of Alzheimer disease (AD). The study hypothesis is that PET imaging of small     molecule probes, in the form of novel fluorescent dyes with radioactive labels, will     demonstrate cerebral patterns in patients with AD that are distinct from those of age-matched     persons who are cognitively intact.   "
237495|NCT00966030|"     This study will demonstrate the definitive bioequivalence of a solid dose formulation of     MK0974 to the liquid filled capsule formulation of MK0974.   "
237496|NCT00966043|"     CYPTAM-BRUT 3 is a prospective, multicentric study in Belgium within the CYPTAM study of the     Leiden University Medical Center (NTR1509) including postmenopausal women receiving tamoxifen     for estrogen-receptor positive breast cancer in the adjuvant setting. The primary endpoint is     the difference in uterine changes between women with a normal versus low TAS after 3 months     of tamoxifen use. Secondary endpoints are serum metabolite concentrations, serum     follicle-stimulating hormone level, serum sex hormone-binding globulin level and menopausal     symptoms. These patients are registered in the Leiden protocol with time to breast cancer     event as primary endpoint.   "
237497|NCT00966056|"     This study evaluates whether Mitomycin C is an effective alternative to septal splints in the     treatment of nasal synechiae.   "
237498|NCT00966069|"     The investigators are aiming to learn more about respiratory infections in young children in     the community. To prepare for a larger project, the investigators are conducting this study     to get information about the best way to collect and transport respiratory specimens from     young children. The investigators would like to test whether parents are more likely to     collect a simple respiratory specimen themselves during a child's illness, compared to the     likelihood of specimen collection when a home visit is made by a health care worker. Further,     the investigators want to compare the likelihood a virus will be identified in both groups.   "
237499|NCT00966082|"     This study is performed to compare the efficacy and safety of EBL alone and EBL combined with     propranolol in patients who were previously performed endoscopic variceal treatment.   "
237500|NCT00966095|"     The purpose of this study is to develop and validate a blood-based diagnostic test that will     predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will     serve to reduce the number of unnecessary prostate biopsies.   "
237501|NCT00966108|"     Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring     with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens   "
237502|NCT00966121|"     Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal     rebleeding. Recently several studies compared the efficacy of EBL alone and with a     combination of propranolol and EBL. However, the results of recent studies showed     discrepancy. This study is performed to compare the efficacy and safety of EBL alone and EBL     combined with propranolol in patients without previous history of endoscopic variceal     treatment.   "
237503|NCT00966134|"     Regulation of ghrelin, growth hormone and growth factors at high altitude and their change     during ascent to high altitude has not been studied in depth yet. The study includes 33     volunteers (12f) investigated at sea level, 4 days after ascent to 3440m and 14 days after     ascent to 5400-5900m.      The investigators hypothesized that during ascent growth hormone levels would increase to     compensate for the higher energy needs at high altitude.   "
237504|NCT00966147|"     The purpose of this study is to determine whether increasing cardiac output by a combination     of intravenous fluids and inotropic drugs can reduce mortality and morbidity in radical     cystectomy operations.   "
237505|NCT00966160|"     Therapy guidelines recommend the use of either the non-nucleoside reverse transcriptase     inhibitor (NNRTI) efavirenz or a ritonavir-boostered protease inhibitor (PI) plus 2     nucleoside reverse transcriptase inhibitors (NRTI) as first-line treatment regimes of HIV-1     infection. Recent clinical studies suggest potential advantages of NNRTI- over PI-based     regimes in therapy initiation due to lower rates of virologic failure and less metabolic     side-effects. In contrast, PI regimes were claimed to cause greater increases in CD4 cell     count than NNRTI regimes, which has been attributed to intrinsic antiapoptotic effects of the     PI. However, it is still unclear whether the immunological response to a PI-containing regime     is greater than to an NNRTI-containing regime, whether there is a difference in the extent of     reduction of apoptosis between PI and NNRTI regimes and whether a difference in apoptosis is     associated with a difference in CD4 cell recovery.      We conducted a controlled, long-term, random matched pair design study in HIV-1 infected     individuals under sustained virologic suppression to evaluate in head-to-head comparison the     clinical effects of a constant PI-based or NNRTI-based regime on CD4 cell recovery and the     underlying molecular, biochemical and functional mechanisms.   "
237506|NCT00966173|"     This is an international, multicenter, prospective, non controlled, non randomized, clinical     study to collect electrical impedance data of potentially malignant pigmented nevi and     histological diagnoses (International Melanoma Algorithm Training Study [IMATS]). The study     objective is to collect data for training and optimization of an algorithm that can classify     skin lesions using electrical impedance, i.e., to identify malignant melanomas.   "
237507|NCT00966186|"     The purpose of this study is to compare two insertion techniques of large size ProSeal     laryngeal mask airway. We hypothesized that insertion of ProSeal laryngeal mask airway with     90-degree rotation would reduce the contact surface between the device and pharyngeal wall     and make it easy to advance the device over the smooth angle against the posterior pharyngeal     wall.We compared the success rate and incidence of complication of the standard technique     with the rotational technique.   "
237508|NCT00966199|"     The purpose of this study is to determine if a reduction in systolic blood pressure induced     by anti-hypertensive medication results in changes in cerebral perfusion and cognition in     hypertensive elderly. Hypertensive elderly will be treated using open-label anti-hypertensive     medication for 8-12 weeks. Changes in cerebral perfusion and cognition will be assessed     before and after treatment.   "
237509|NCT00966212|"     The study has the potential to improve understanding of the link between early alcohol and     sexual initiation and to provide a proven, selective, female-focused intervention for     addressing these risks. The goal is to set young women on a course that protects their health     and reduces the burden that problem drinking and HIV disease is taking on African American     and Latino communities.   "
237510|NCT00966225|"     The purpose of this study is to determine a safe and tolerable dose of LIP-01   "
237511|NCT00966238|"     A multi-center, open-label, escalating dose-ranging study to assess the safety,     reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg,     2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. Hypothesis: VAX125     is safe and immunogenic at one or more of the doses tested.   "
237512|NCT00966251|"     The objective of this pilot study is to evaluate the safety, tolerability and activity of the     monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular     Carcinoma.   "
237513|NCT00966264|"     A randomised study including 236 women referred for essential menorrhagia to five university     hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life     issues in the treatment of menorrhagia.Participants were randomly assigned to treatment with     LNG-IUS (n=119), or hysterectomy (n=117), and were monitored for ten years. The primary     outcome measures were health related quality of life (HRQoL), other measures of psychosocial     well-being (anxiety, depression, sexual functioning), and costs.   "
237514|NCT00966277|"     The goal of this clinical research study is to learn if dalteparin can lower the risk of VTE     occurring in the legs and lungs. This will be tested in patients with pancreatic cancer who     are going to receive chemotherapy. Some patients will receive dalteparin and some will     receive no study drug.      The safety of dalteparin will also be studied.   "
237515|NCT00966290|"     Background: Whether the management of vitamin K antagonists (VKA) therapy by general     practitioners with the collaboration of anticoagulation clinics (ACC) provides better     clinical outcomes than that accomplished by general practitioners alone (usual care [UC]     management) is not clear.      Objectives: To compare ACC-based shared-care management with UC management of VKA therapy     with respect to clinical events.      Patients/Methods: Open, randomized, multicenter study in patients starting VKA therapy for at     least three months. The primary study outcome is a composite of confirmed symptomatic     thromboembolic or major bleeding events. All-cause mortality is a secondary outcome. All     outcomes are reviewed by a central, independent adjudication committee.   "
237516|NCT00966303|"     This quantitative study aimed to evaluate the respiratory muscle strength, pulmonary     function, cardiovascular function, and impact on quality of life in patients after cardiac     rehabilitation associated with the diaphragmatic muscle training.   "
237517|NCT00966316|"     The purpose of this study is to determine whether the clinical pathway for acute ischemic     stroke(with combination of traditional Chinese medicine and western medicine) is able to     improve the outcome of acute ischemic stroke and evaluate its effect on hospital day and     cost, etc. Meanwhile, the study will discuss the safety and efficiency of this kind of     Clinical Pathway   "
237518|NCT00966329|"     Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the     following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the     NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.   "
237519|NCT00966342|"     This is an invitation to consider taking part in a research study occurring just before the     upcoming influenza vaccination program across Canada. The purpose of the study is to closely     assess influenza vaccine safety and immune responses, as part of a nationwide, annual     surveillance project sponsored by the Public Health Agency of Canada. Such scrutiny is     important given the changing nature of flu vaccines from year to year.   "
237520|NCT00966355|"     In patients who are suspected to have variceal bleedings, pharmacologic therapy with     vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as     possible, even before endoscopy. However, it is still unclear whether the efficacies of these     drugs are same or not. This study is performed to compare the efficacy of terlipressin,     somatostatin, and octreotide in patients with variceal bleeding for the control of variceal     bleeding in combination with endoscopic therapy.   "
237521|NCT00966368|"     This trial was conducted in North America. The aim of this clinical trial was to investigate     if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the     body.   "
237522|NCT00966381|"     Approximately 8 million American women suffer from osteoporosis, and one out of every two     women over the age of 50 will have an osteoporotic-related fracture in their lifetime (42).     While epidemiological studies suggest that pregnancy and lactation are not associated with     risk of fractures later in life, these studies did not control for site-specific decrements     in bone mineral density (BMD). In addition, 55% of American women between the ages of 20 to     39 are overweight (14). Excess weight retention after pregnancy increases a woman's risk for     developing a chronic disease later in life (44). There is a paucity of research on exercise     and dietary interventions in postpartum lactating women aimed at promotion of bone health and     weight loss.      The goal of this study is to promote long-term lifestyle changes through a home based     strength training, aerobic, and nutrition intervention targeting overweight lactating women.     The objective is to attenuate lactation-induced bone loss and promote weight loss. We     hypothesize that the intervention group will lose a greater amount of fat mass while     preserving lean mass and bone mineral mass and increase levels of anabolic hormones through     diet and exercise compared to the minimal care group. Additionally, the acquisition of such     knowledge is unique since no other studies have measured growth hormone and insulin-like     growth factor-1 in lactating women with respect to bone and exercise. This intervention will     encourage breastfeeding, weight loss and an increase in bone density resulting in healthy     infants and mothers.      The proposed research is the first to examine the effects of a resistance exercise and weight     loss intervention on attenuation of lactation-induced bone loss in overweight women. To our     knowledge, this is the first study to use MyPyramid for Menu Planner for Moms for dietary     counseling using the total diet approach. The expected outcomes are the intervention group     will lose weight while preserving lean body mass, bone mineral mass and increase     cardiovascular fitness and strength compared to the minimal care group. Additionally, the     exercise group will improve the overall quality of their diet using internet based     technology. An increase in activity and promotion of weight loss through a modest reduction     in calories may lead to overall improvement of the mother's bone and health status later in     life.   "
237523|NCT00966394|"     Attention deficit and hyperactivity (ADHD) affect 6% of school-aged children. Few studies     reported higher prevalence of caries and restorations among children with ADHD.     Methylphenidate is the drug of choice to treat ADHD. according to the medical literature     methylphenidate can cause xerostomia.      Our study will investigate saliva parameters (such as quantity, bacteria in saliva, buffer     capacity), oral hygiene and diet habits and their influence on caries among children with     ADHD and among healthy children.      Our hypothesis is:        -  Children with ADHD will have more caries.        -  Children with ADHD will have more detrimental oral hygiene and diet habits.        -  There will be a difference in the saliva parameters between children with ADHD and          healthy children.   "
237524|NCT00966407|"     The AIMM Young study is a collaboration between Children's National Medical Center (CNMC) and     colleges/universities nationwide--currently including Howard University (HU), East Carolina     University (ECU), and University of Massachusetts, Amherst (U Mass). This study obtains a     variety of baseline measures (such as serum biomarkers related to metabolic syndrome,     anthropometrics, muscle strength, and fitness testing) along with genetic information from     healthy college-age (18-35 years) young adults in efforts to identify phenotype-genotype     associations that may predispose individuals to developing metabolic syndrome, type 2     diabetes, and/or related diseases such as obesity.      We hypothesized that certain genetic variations will be protective against metabolic     syndrome, while others will show a strong correlation with specific components of metabolic     syndrome disease. We expect that the study of pre-symptomatic, young individuals will     facilitate the identification of genetic risk loci for metabolic syndrome and type 2     diabetes. Younger populations typically have less confounding variables, and this facilitates     normalizing of metabolic syndrome features and environment/lifestyle. Additionally, young     subjects can provide more robust longitudinal data, and be recruited into subsequent     interventions to reverse the trend towards metabolic syndrome, rather than the more difficult     task of reversing type 2 diabetes in older populations. The data collected will be stratified     according to gender, age, ethnicity, genotype, and other phenotypic measures to determine how     these factors influence disease risk.   "
237525|NCT00966420|"     The purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the     large (and small) intestine can be facilitated by using a traction on the lesions.   "
237526|NCT00966433|"     The purpose of this research study is to compare difference between breathing by oneself or     with the partial help from an anesthesia machine in children under general anesthesia.   "
237527|NCT00966446|"     The overall goal of this project is to elucidate the epidemiology of MRSA transmission in the     community and test an intervention to prevent MRSA transmission in this setting.   "
237528|NCT00966459|"     In this study, 20 COPD patients will undergo a high-resolution/multi slice CT scan and lung     function tests to obtain patient specific geometries of the central and peripheral small     airways and patient specific boundary conditions.      With Computational Fluid Dynamics (CFD), the investigators will be able to reconstruct the     geometry and measure the resistance of the peripheral airways.      In a later stage, CFD will be used to simulate the reaction of the airways on various     inhalation medications.   "
237529|NCT00966472|"     The purpose of this study is to determine the recommended phase II dose (RP2D) of     rosuvastatin that can be given in combination with standard erlotinib treatment in patients     with advanced incurable squamous cell cancer and NSCLC.   "
237531|NCT00966498|"     Before the transplant, the patient will have a pre-transplant evaluation. This will help find     out whether there are health problems that will prevent the transplant. It also provides     baseline tests that will be used later to see whether or not organs have gotten better or     worse after the transplant. Prior to the stem cell collection, the patient will get     chemotherapy to help try to put him/her in remission and to push more stem cells into the     peripheral blood (mobilization). The study doctor will decide which chemotherapy will be used     for this part of the study. Once mobilization is completed, the peripheral blood stem cell     collection (apheresis) will be done in the clinic. The apheresis machine will draw blood out     of the central line. The blood then passes through the apheresis machine and the stem cells     are separated out. The remaining blood is sent back through the central line. If the     investigators are unable to collect enough peripheral blood stem cells, a bone marrow harvest     may be necessary to collect more stem cells.      The patient will then be admitted to the hospital for the first transplant. He/she will get     Thiotepa and Cyclophosphamide. Then the patient will be given back the cells that were     collected. The cells are given in the same manner as a blood transfusion. The patient will be     kept in the hospital until he/she is stable and blood counts are increasing. Approximately 6     to 8 weeks after Day 0 of the 1st transplant, the patient will be admitted for the second     transplant. At this time, he/she will get Busulfan and Melphalan and then the collected cells     will be given back. The patient will be kept in the hospital until he/she is stable and blood     counts are increasing. Frequent clinic follow-up is required.      This study is open to patients who are less then 21 years of age with refractory or relapsed     high-risk, solid tumors, excluding neuroblastoma (there is a cooperative group trial for     these patients). Patients will be identified by the Transplant team and eligibility will be     verified by a member of the clinical research team. Patients will be cared for by members of     the Transplant team and various other subspecialty physicians.   "
237532|NCT00966511|"     The primary purpose of the study is to investigate the use of VRI to guide the selection of     patients for lung surgery. Perfusion scintigraphy is the current method to assess the     fractional contribution of lung function of the remaining lung.      The hypothesis is that VRI can determine quantitative postoperative lung function equally     accurately as a quantitative perfusion scan.   "
237533|NCT00966524|"     Purpose: This study is designed to assess the impact of teaching tracheal intubation using     video-guided feedback on the ability to perform and maintain this clinical skill by medical     students.      Hypothesis: We hypothesise that, for novices, video-guided feedback provided during tracheal     intubation will improve learning and retention of this clinical skill compared to standard     teaching using direct visualization feedback.   "
237534|NCT00966537|"     The aim of this study is 1) to study the clinical application of 3D/4D ultrasound for fetal     scanning during pregnancy; 2) ) to study the clinical application of 3D/4D ultrasound for     pelvic scanning; 3) to demonstrate how to optimally display the different organs. 4) to     correlate our findings with other diagnostic tools like MRI, CT; 5) to correlate our findings     with clinical outcome.   "
237535|NCT00966550|"     The purpose of this research study is to test whether certain compounds in tomatoes will help     reduce factors in the subject's blood associated with disease risk. The investigators want to     know if the tomato-associated compounds will lower or improve the status of these factors,     like cholesterol and inflammation. In this research study, the subject will be asked to     consume high fat test meals on two separate occasions. The investigators want to see how the     subject's body responds to a standard high fat meal, one meal with tomato products and one     meal without tomato products. The investigators will measure the subject's blood throughout     the study period to determine if consumption of tomato products reduces factors in their     blood associated with disease risk.   "
237536|NCT00966563|"     The present feasibility study is designed to find out whether pre-treatment with the compound     mangafodipir (PP-099) provides an additional reduction in myocardial infarct size in patients     treated with primary percutaneous coronary intervention (PCI) during acute myocardial     infarction (AMI).   "
237537|NCT00966576|"     The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma     patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin     monotherapy.   "
237538|NCT00966589|"     Five to ten percent of athletes and physical active adults are suffering chronic groin pain.     The most common diagnoses are adductor tendinitis, sportsman hernia and osteitis pubis.     Sportsman hernia is not a real hernia in the groin, but overuse injury of the groin muscles     and tendons. No evidence-based treatment of this disabling condition has been found so far.     Experimental surgical treatments are based on various hernioplasties. Laparoscopic     extraperitoneal hernioplasty (TEP) is a mini-invasive and effective method to heal sportsman     hernia in non-randomized cohorts.   "
237539|NCT00966602|"     The purpose of this study is to assess the pharmacokinetics and safety of co-administration     of VX-770 and VX-809 in healthy adults.   "
237540|NCT00966615|"     Chronic utilization of bio-incompatible peritoneal dialysis (PD) solution has been implicated     as a cause of progressive loss of peritoneal permeability and recurrent fluid overload in PD     patients. Previous studies show that PD solution with neutral pH and low GDP resulted in a     superior profile of PD effluent mesothelial cell marker and a lower degree of systemic     inflammation as compared to conventional PD solution. The investigators propose a prospective     randomized control study to compare the arterial stiffness, nutrition and body fluid status     between PD patients treated with conventional solution and those with neutral pH low GDP     solution. The investigators plan to study 100 new PD patients. They will be randomized to be     treated with neutral pH low GDP solution or conventional solution. All patients will be     followed for 52 weeks. In addition to routine clinical measurements, the investigators will     measure their body water composition by bioimpedance spectroscopic method, arterial pulse     wave velocity by pressure transduction method, as well as radiographic parameters of     intravascular volume status, based on the routine chest radiograph. The study would help to     define the clinical benefit of biocompatible PD solution.   "
237541|NCT00966628|"     Dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS) are among the leading causes     of pediatric hospitalization in Asia.Mortality rates range from 1% at centres experienced in     fluid resuscitation, to upto 44% in established shock.The mainstay of DSS treatment is     prompt, vigorous fluid resuscitation with isotonic crystalloid solutions, followed by plasma     or colloid solutions for profound or continuing shock. However, this administration is often     associated with fluid overload and induces edema in these patients.      Hence, we planned a parallel, randomized controlled trial comparing the efficacy and safety     of solution containing half molar sodium lactate (Totilac™) with standard treatment(isotonic     crystalloid Ringer's Lactate) in pediatric Dengue Shock Syndrome patients, using plasma     soluble Vascular Cell Adhesion Molecule(sVCAM-1) levels as an indicator.      Hypertonic solutions restore hemodynamic status rapidly with increased cardiac performance     and improved tissue perfusion. This is obtained with much smaller volumes.We plan to assess     the efficacy and safety of hypertonic sodium lactate in resuscitation of DHF/DSS patients.   "
237542|NCT00966641|"     The purpose of this study is to determine the single-dose pharmacokinetics of the     investigational drug PL 3100 following oral administration to healthy volunteers and to     compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.   "
237543|NCT00966654|"     This research is being done to see if giving a hormone called GLP-1 can improve heart     function and reduce length of stay in the Cardiac Surgical Intensive Care Unit (CSICU) in     people who have non-emergent coronary artery bypass graft (CABG) surgery.   "
237544|NCT00966667|"     RATIONALE: Gathering information over time from patients who have finished treatment for     colorectal cancer may help doctors predict which cancer survivors will improve their physical     activity and diet.      PURPOSE: This clinical trial is studying health behaviors in patients who have finished     treatment for stage I, stage II, or stage III colorectal cancer.   "
237545|NCT00966680|"     The researchers wish to undertake a simulation based study to compare the speed of general     versus spinal anesthesia for emergency cesarean delivery. Minutes may matter for the baby in     an emergency. It is unknown which technique is quicker. Their hypothesis is that surgical     anesthesia can be achieved as quickly with spinal as with general anesthesia.   "
237546|NCT00966693|"     The goal of the Phase I portion of this clinical research study is to find the highest     tolerated dose of the combination of thalidomide, lenalidomide, and dexamethasone that can be     given to patients with relapsed or refractory MM.      The goal of the Phase II portion of this study is to learn if the drug combination can help     to control the disease.      The safety of the drug combination will be studied in both phases.   "
237547|NCT00966706|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, capecitabine, gemcitabine     hydrochloride, epirubicin hydrochloride, and docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known     whether cisplatin, capecitabine, and gemcitabine hydrochloride are more effective when given     together with epirubicin hydrochloride or docetaxel in treating patients with advanced or     metastatic pancreatic cancer.      PURPOSE: This randomized phase II trial is studying the side effects of giving cisplatin,     capecitabine, and gemcitabine hydrochloride together with epirubicin hydrochloride compared     with giving cisplatin, capecitabine, and gemcitabine hydrochloride together with docetaxel     and to see how well it works in treating patients with stage III or stage IV pancreatic     cancer.   "
237548|NCT00966719|"     Breastfeeding decreases the risk of many infantile infectious diseases and certain types of     cancers in women. It strengthens the bond between mothers and babies and decreases the health     care cost to society by making children healthier. Although it is controversial,     breastfeeding has been reported to increase the risk of jaundice in the neonatal period.     There is some evidence that mothers of hospitalized jaundiced infants discontinue     breastfeeding early, as they feel responsible for the baby's condition.      The main objective of this study is to determine the effect of a breastfeeding intervention     on breastfeeding duration in jaundiced infants. All eligible infants will be randomized to     one of two groups (an intervention or a control group). Mothers of infants in the     intervention group will meet with a lactation consultant during their hospital stay, and     three times post hospital discharge. Lactation consultants are individuals who have received     certification in breastfeeding support from an international board, ensuring safe and     effective practice. Mothers of infants in the control group will receive the current standard     of care, which is typically support from the nursing staff, who are often not trained in     lactation support. Information will be collected on length of time that infants are fed only     breast milk, future visits to health care providers, mothers' need for breastfeeding support     post hospital discharge, mothers' perception of their physicians' attitudes towards     breastfeeding, and mothers' experiences at the hospital, as well as feedback on the     intervention. Phone follow-up will occur one week post hospital discharge, and when the child     is 2, 3, 4 and 6 months old.      The results of this study will clarify the importance of offering sound breastfeeding advice     to mothers of young infants hospitalized with jaundice and help determine whether there is a     need for trained lactation specialists in children's hospitals. It will allow us to examine     whether such an intervention can have a quantifiable impact on children's health in their     first 6 months of life, as measured by physician encounters and hospitalizations. It will     also allow collection of information on advice and support given to breastfeeding women by     primary care physicians, potentially identifying needs for more rigorous breastfeeding     training during medical training.   "
237549|NCT00966732|"     Fibromyalgia is a common, costly and debilitating illness which affects mostly women.     Fibromyalgia patients report widespread musculoskeletal pain, fatigue, stiffness, and     distress. Several consensus statements indicate that optimal care combines medication,     exercise, and psychology. Yoga is a popular mind/body discipline which holds promise for     reducing fibromyalgia symptoms. The aim of this pilot study is to evaluate the effects of an     innovative program, Yoga of Awareness, in which yoga poses are complemented by meditation and     breathing exercises, presentations on healthy coping, and group discussions. Fifty-six women     with fibromyalgia will be recruited and randomly divided into two groups. One group will     receive the yoga program right away, and the other group will wait 3 months before receiving     the program. Information about fibromyalgia symptoms and functioning will be collected from     both groups before and immediately after the first group receives the yoga program. When     results from the 2 groups are compared, the investigators expect patients who received the     yoga program will have greater gains in fibromyalgia symptoms, physical function and pain     coping capacities then those waiting to receive the program. If this study shows the yoga     program is effective, the investigators will use this data in 2010 to apply to the National     Institutes of Health for a more complete study of its benefits.   "
237550|NCT00966745|"     Maintaining a low central venous pressure during living donor hepatectomy is routine     practice. The investigators tried to test the hypothesis that using milrinone to maintain a     low central venous pressure (CVP) during is associated with a superior surgical field and     less blood loss.   "
237551|NCT00966758|"     In this open prospective study, 6 well controlled asthmatic patients will undergo a     high-resolution multi-slice computed tomography (CT) scan, lung function tests and a SPECT     scan to obtain patient specific geometries of the central and peripheral small airways,     patient specific boundary conditions and the in-vivo spatial distribution of inhaled     aerosols.   "
237552|NCT00966771|"     The purpose of this study is to see if women presenting for emergency contraception (EC) and     choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next     year compared to women who choose oral levonorgestrel for EC. The study will also compare use     of an effective method of contraception in the year after they received EC.   "
237553|NCT00966784|"     The study hypothesis is that 2 Months Daily Supplementation of Orange juice with fibers will     effect the weight and the plasma lipids.      This will be a double-blind parallel controlled study. Study population will include 50     subjects, who will be divided randomly into two groups. The first group will get the Orange     juice with fibers, and the second group will get Orange juice with out the fibers.   "
237554|NCT00966810|"     Allogeneic stem cell transplantation, the only known curative modality for CML, was abandoned     in recent years for a very effective and much less toxic targeted therapy with the tyrosine     kinase inhibitors (TKIs). However, approximately one third of patients still need another     treatment including stem cell transplantation. The study protocol comprised a cohort of     consecutive patients with CML who received allogeneic stem cell transplantation using partial     T cell depletion, with no post-transplant GvHD prophylaxis. Forty consecutive patients with     CML underwent allogeneic stem cell transplantation from a matched sibling using partial T     cell depletion (TCD), in a single institution. Escalated dose of donor lymphocyte infusion     (DLI) was given in case of either relapse or presence of minimal residual disease (MRD) as     detected by cytogenetic or molecular analysis.      The purpose of the study is to decrease transplant-related toxicity.   "
237555|NCT00966823|"     The purpose of this phase 2 limited study is to examine whether prenatal intervention correct     the lung underdevelopment associated with severe diaphragmatic hernia.   "
237556|NCT00966836|"     Cardiac allograft vasculopathy (CAV) is the major cause of long-term graft failure in heart     transplant recipients. Although several immune-mediated and metabolic risk factors have been     implicated in the pathogenesis of CAV, no effective therapy is currently available to treat     established CAV and prevent its adverse outcomes. Therefore, the main clinical strategy is     based on prevention and treatment of factors known to trigger its development. Although the     mechanism is vague, cytomegalovirus (CMV) infection is believed to play a key role in CAV     progression.      Two strategies involving administration of specific anti-CMV agents are recommended for     prevention of CMV infection/disease: universal prophylaxis and preemptive therapy. The pros     and cons of the two strategies are still debated, in the absence of randomized studies     addressing graft-related outcomes and viral mechanisms of graft damage, and without any clear     evidence of superiority of either approach.      The investigators conceived this randomized prospective project to compare the effect of     preemptive anti-CMV strategy with universal anti-CMV prophylaxis on CMV infection and on     one-year increase in coronary intimal thickening. Patients will be additionally randomized to     receive either mycophenolate mofetil or everolimus, in light of the possible anti-CMV     properties of everolimus.   "
237557|NCT00966849|"     The purpose of this study is to determine whether cash transfers (conditional and     unconditional) can improve health and social outcomes amongst children living in vulnerable     households in Manicaland, eastern Zimbabwe. The study hypotheses are:        1. Cash transfers will increase the percentage of vulnerable children aged 0-4 years with a          birth certificate.        2. Cash transfers will increase the percentage of vulnerable children aged 0-4 years with          up-to-date vaccinations.        3. Cash transfers will increase the percentage of vulnerable children aged 6-12 years          attending primary school at least 80% of days per month.   "
237558|NCT00966862|"     The aim of this study is to investigate the glycemic effect of supplementation Fibers in     orange juice.      This will be a double-blind parallel controlled study. Each subject will serve as his own     control.      Study population will include 10 subjects. The subjects will be randomly assigned to receive     one of two juices in occasion, in two visits. Each drink will be containing orange juice     with\without fibers.   "
237559|NCT00966875|"     The primary purpose of the study is to help answer the following research questions, and not     to provide treatment for Rheumatoid Arthritis (RA):        -  The safety of LY2439821 and any side effects that might be associated with it.        -  Whether LY2439821 can help participants with active RA.        -  How much LY2439821 should be given to participants.   "
237560|NCT00966888|"     RATIONALE: Radiation therapy uses high-energy x-rays or other types of radiation to kill     tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain     after surgery. It is not yet known whether radiation therapy is more effective than     observation after mastectomy in treating women with stage II breast cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it     works compared with standard therapy in treating women with stage II breast cancer who have     undergone mastectomy.   "
237561|NCT00966901|"     An evaluation of the effects of UV exposure following the use of a new nicotine patch.   "
237562|NCT00966914|"     Tavocept is an investigational drug that is being developed to see if it can increase the     survival of patients who are being treated with chemotherapy as well as to see if it can     prevent or reduce side effects of chemotherapy. This research study is aimed at trying to     find out if people with advanced adenocarcinoma of the lung who are treated with a standard     combination of chemotherapy drugs will live longer if they are also treated with an     investigational drug called Tavocept. Another objective of this research study is to find     out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage,     anemia, and nausea and vomiting that can occur with these drug combinations. The drug     combinations that will be used in this research study will include either paclitaxel and     cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to     treat people with advanced NSCLC. Every patient on this research study will be treated with     standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these     will be recommended by your research study doctor), which will be given in combination with     cisplatin.   "
237563|NCT00966927|"     The purpose of this study is to investigate the level of functional independence and the     quality of life of adolescents and young adults with spina bifid in an Italian population.   "
237564|NCT00966940|"     The purpose of this study is to assess the safety and efficacy of Travoprost 0.004% and     Tafluprost 0.0015% in patients with primary open angle glaucoma or ocular hypertension when     both medications are administered in the evening.   "
237565|NCT00966953|"     Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a     4-day brushing regiment   "
237566|NCT00966966|"     The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the     plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to     assess the safety and tolerability of co-administration of SAM-531 and Gemfibrozil.   "
237567|NCT00966979|"     The purpose of the study is to evaluate the Triathlon® PKR Knee System and determine whether     or not the success rate of this device is no worse than the reported success rate of similar     devices.   "
237568|NCT00966992|"     The treatment of cervical cancer with chemotherapy and radiation will make women post     menopausal (no estrogen from the ovaries), if a woman is not already in menopause. Estrogen     plays a key role in maintaining bone health. Therefore, these women are at higher risk of     getting osteoporosis (decrease minerals in the bone) and bone fractures. The overall purpose     of this research is to look at the effects of zoledronic acid (Zometa) on preventing bone     loss. Studies have also shown that zoledronic acid may prevent metastasis to the bone which     can occur in women with cervical cancer. Zometa is investigational (not approved by the Food     and Drug Administration (FDA)) in this study to prevent metastasis to the bone in women with     cervical cancer. Therefore, the goal of this study is to also look at the effects of     zoledronic acid (Zometa) on circulating tumor cells in the bone marrow and blood. This study     is being done to find a way to prevent bone loss and metastasis to the bone in women     undergoing chemotherapy and radiation for cervical cancer. An additional component of the     study is to assess the importance of stress on immune markers in blood during standard     treatment.   "
237569|NCT00967005|"     The objective of this application is to examine whether, given its mechanism of action, the     dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and pathological     gamblers (PG) symptoms in nicotine dependent pathological gamblers.   "
237570|NCT00967018|"     Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30     (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of     degarelix until the drug is launched in their country. Safety parameters such as     electrocardiogram (ECG), blood and urine samples and general health state will be studied.     Note: patients completing the CS27 trial did not participate in the CS34 trial.   "
237571|NCT00967031|"     RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving lapatinib ditosylate     together with capecitabine may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with     capecitabine works in treating patients with stage IV breast cancer and brain metastases.   "
237572|NCT00967044|"     Objectives:      Primary:        -  Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the novel          combination of everolimus + Panobinostat (LBH589) in a phase-I study in patients with          relapsed lymphoma (Hodgkin and non-Hodgkin).        -  Determine the safety and efficacy of this novel combination in a phase-II study in          patients with relapsed Hodgkin and non-Hodgkin lymphoma      Secondary:        -  Determine the in vivo effect of therapy on selected serum cytokines/chemokines          (TGF-beta, thymus and activation-regulated chemokine (TARC), IL-6, IL-10, VEGF).        -  Examine pre-treatment level of selected molecular targets (HDACs 1-11, STAT6, pSTAT6,          STAT3, pSTAT3, Myc, Akt, Pichia anomala killer toxin (pAkt), S6, pS6, p21, cyclin D1) in          primary lymphoma cells and the surrounding reactive inflammatory cells obtained by core          needle biopsies from patients with relapsed lymphoma.        -  Examine the correlation between molecular and biologic markers and clinical response          and/or treatment-related toxicity.   "
237573|NCT00967057|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. It is not yet known     which combination chemotherapy regimen is more effective in treating young patients with     acute lymphoblastic leukemia.      PURPOSE: This partially randomized phase III trial is studying how well combination     chemotherapy works in treating young patients with relapsed or refractory acute lymphoblastic     leukemia.   "
237574|NCT00967070|"     An investigation on the skin sensitization potential of a new nicotine patch. Evaluation of     the potential of a new nicotine transdermal patch to cause sensitization in the skin after     repeated applications.   "
237575|NCT00967083|"     This study is being done to learn what the needs are in relation to the family members. Some     family members seek counseling; others do not. The institution wants to try to understand why     and wants to see if they can improve our support services for family members.   "
237576|NCT00967096|"     Acute graft versus host disease is a frequent and often life threatening complication of     allogeneic blood and marrow transplantation. The bacteria that normally reside in the     intestine play a critical role in its development. Injury to the lining of the bowel that     results from the high dose chemotherapy or radiation that transplant patients receive during     the week preceding the transplant allows the bacteria to invade the intestines and spread to     nearby lymph nodes. This, in turn, causes inflammation which has been shown to promote GVHD.     Both pre-clinical and clinical research has demonstrated that oral antibiotics can prevent     graft versus host disease by inhibiting these gut bacteria. Rifaximin has several features     that suggest it could be effective in preventing GVHD. Rifaximin prophylaxis might also     provide an added benefit by protecting highly immunocompromised transplant patients from     severe bacterial infections. This pilot trial will allow the investigators to determine the     feasibility of using Rifaximin for prevention of GVHD and infection in patients undergoing     allogeneic blood and marrow transplantation. The preliminary results will be used to plan a     more definitive trial.   "
237577|NCT00967109|"     The purpose of this study is to determine whether a higher threshold for transfusion with red     blood cells improves the tissue oxygenation.   "
237578|NCT00967122|"     AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before     and after a band holiday, in addition to surveying hunger/satiety and behavior changes.   "
237591|NCT00967291|"     RATIONALE: Drugs used in chemotherapy, such as mitomycin C and ifosfamide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving mitomycin C together with ifosfamide     works in treating patients with metastatic pancreatic cancer.   "
237592|NCT00967304|"     The main objective of this study is to verify whether a new clinical decision rule     identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence     can safely stop oral anticoagulant therapy after 5-7 months of treatment.   "
237579|NCT00967135|"     This study is designed to assess:        1. The impact of taking perioperative pregabalin on the incidence of chronic neuropathic          pain and postthoracotomy syndrome at 3 months in patients who have undergone a          thoracotomy with a thoracic epidural as the basic analgesic modality.        2. The impact of taking perioperative pregabalin on the relief of acute pain, and on the          use of additional analgesics, such as opioids, for the relief of such pain in patients          who have undergone thoracic surgery with a thoracic epidural as the basic analgesia.        3. The impact of taking perioperative pregabalin on the quality of life and level of          functioning of patients who underwent thoracic surgery 3 months earlier.        4. The safety profile of pregabalin in this patient population.      Hypothesis: The basic hypothesis in this study is that a dose of pregabalin administered     preemptively 1 hour before a thoracotomy, then repeatedly during the postoperative period,     when neuronal hyperexcitability is at a maximum (i.e., 4 days), will lead to a 33.3% decrease     in the prevalence of chronic pain 3 months after surgery.   "
237580|NCT00967148|"     The blood thinner tinzaparin might increase survival in patients with colon cancer     undergoing surgical resection. The investigators want to assess if a trial allocating     patients to prolonged treatment with tinzaparin versus standard of care is feasible.   "
237581|NCT00967161|"     The purpose of the current study is to analyze and compare the lower-limb joint motions and     muscle activation patterns during activities of daily living as well as self reported health     related functional outcomes for patients with osteoarthritis of the knee undergoing one of     two types of knee replacements: the Evolution Medial Pivot knee (Wright Medical) or the     Triathlon Posterior Stabilized (PS) knee (Stryker Orthopaedics).   "
237582|NCT00967174|"     An investigation on the cumulative skin irritation potential of a newly developed 25 mg     nicotine patch. Evaluation of skin irritation of a newly developed 25 mg nicotine transdermal     patch   "
237583|NCT00967187|"     To evaluate the antiretroviral activity and safety of 200 mg BID and 300 mg BID doses of     MPC-4326 administered as monotherapy for 14 days to HIV-1 positive patients. Patients with an     initial treatment response will have the option to continue MPC-4326 in combination with an     Optimized Backround Regimen for a maximum of 72 weeks.   "
237584|NCT00967200|"     RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients will respond to     treatment.      PURPOSE: This research study is looking at tissue samples from patients with glioma or other     brain tumors.   "
237585|NCT00967213|"     The purpose of this study is to evaluate changes in preferential hyperacuity perimeter (PHP)     and fundus autofluorescence (FAF) in patients with neovascular age-related macular     degeneration receiving combination of ranibizumab (LucentisTM) and verteporfin (Visudyne®)     therapy   "
237586|NCT00967226|"     Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one     year of life and do not need treatment. Others require treatment because they cause     significant symptoms such as pain, or difficulty with breathing, eating or ambulating.     Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3     of patients. Unfortunately, steroids have many side effects in babies so physicians have     sought other ways to treat them. Recently, the use of propranolol, a heart medication, was     serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side     effects than steroids but it is not yet known if it works as well as steroids. This study     seeks to compare the effect and the side effects of propranolol versus steroids for treating     hemangiomas that cause symptoms in infants.   "
237587|NCT00967239|"     RATIONALE: Studying the genes expressed in samples of blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study is looking at blood samples from high-risk postmenopausal women     who received treatment on breast cancer prevention clinical trials NSABP-P-1 or NSABP-P-2.   "
237588|NCT00967252|"     Despite improvements in perioperative care, non-cardiac surgery remains associated with     significant and costly complications. Analysis of perioperative deaths in the United Kingdom     suggests that roughly 80% are directly attributable to infectious and cardiovascular     complications. The best available evidence suggests that medical optimization is the     preferred strategy to reduce cardiac risks but there has been no novel strategy to reduce     nosocomial infection rates in over 20 years.      Emerging evidence in both the non-operative and operative setting suggest that statin drugs     may prevent both infectious and cardiac events. The mechanism(s) of action are not entirely     clear but appear to independent of lipid lowering effects and are often referred to as     pleiotropic effects. Two key elements of the pleiotropic effects of statins appear to be     their anti-inflammatory properties and improved endothelial vascular reactivity. The statin     dose required to maximize these effects is unknown. A large observational trial suggests a     contradictory dose effect with higher doses associated with reduced infectious complications     and lower doses associated with fewer cardiac complications. Doctors therefore still have     many unanswered questions about the use of statins in the perioperative setting. Should they     be routinely started on all or only certain surgical patients? What dose of statin should be     used? If a patient is already on a statin, should their dose be altered perioperatively? The     latter question is particularly relevant in light of the marked increase in statin use.     Recruitment logs for an ongoing trial demonstrate that over 70% of patients undergoing     high-risk surgery were taking a statin but at markedly variable doses. This population     presents an ideal opportunity to determine if there is a dose response relationship between     statins and pleiotropic effects. We therefore propose an observational study that will     determine anti-inflammatory and endothelial effects in high-risk surgical patients on varying     doses of a perioperative statin drug.      Atorvastatin diminishes the rise in C-reactive protein (CRP), measured 48 hours after     elective vascular surgery, in a dose dependent fashion.      Secondary Hypotheses:      Atorvastatin reduces endothelial dysfunction after elective vascular surgery, as measured by     brachial artery ultrasound, in a dose dependent fashion.   "
237589|NCT00967265|"     Patient participation is a central concept in Norwegian health policy. It is mandatory in     hospitals and emphasised as one of the most prioritised areas by the Government. Studies from     Norway have repeatedly found that patients who seek help in community mental health centres     (DPS) are dissatisfied with the information they receive and about their possibility for     real influence in their treatment.      One way to improve individual patient participation might be to give patients information     before they start their treatment. This can be done as group based patient education to     reduce the resources needed. Furthermore, as there are waiting lists for treatment, such     introduction seminars could be held while patients are waiting to use this time in a     meaningful way.      The present study therefore aims at testing the effect of an introduction seminar for     patients on waiting list in a community mental health centre.   "
237590|NCT00967278|"     The purpose of this study is to study the positioning and stabilization of different cardiac     walls performed during off-pump coronary artery bypass grafting (CABG) may have dissimilar     impact on hemodynamics.      The objective is to evaluate hemodynamics during distal coronary anastomoses in different     cardiac walls.   "
237594|NCT00967330|"     This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in     combination with conventional involved field radiotherapy, in patients with newly diagnosed     glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive     Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide     75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po     daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until     disease progression, and the target sample size is 100-500 individuals.   "
237595|NCT00967343|"     The purpose of this study is to determine whether the administration of a donor lymphocyte     preparation depleted of functional host alloreactive T-cells (ATIR) after a T-cell depleted     stem cell transplant from a related, haploidentical donor enhances survival by improving the     immune effect against infections while preventing graft-versus-host disease .   "
237596|NCT00967356|"     The aims of this study are to assess the safety, tolerability and pharmacokinetics of single     ascending oral doses of AZD5985 in healthy male subjects.   "
237597|NCT00967369|"     The goal of this clinical research study is to learn if bortezomib when given in combination     with ifosfamide, carboplatin, and etoposide (a routine chemotherapy combination called ICE)     can help to control Hodgkin's lymphoma better than ICE when given alone. The safety of this     drug combination will also be studied.   "
237598|NCT00967382|"     The TIPPS trial seeks to determine the safety and effectiveness of low-molecular-weight     heparin (LMWH), an anticoagulant, in preventing placenta mediated pregnancy complications and     venous thromboembolism (VTE) in women with thrombophilia. Thus, the principal research     question is: can LMWH prevent thrombosis in the leg veins, pulmonary arteries and placental     vessels, thereby reducing the risk of deep vein thrombosis, pulmonary embolism (PE),     intrauterine growth restriction (IUGR), preeclampsia, miscarriage and stillbirth?   "
237599|NCT00967395|"     The hypothesis is that healing may influence the patient's general status by altering     psychological as well as other body functions of importance for the rheumatoid arthritis.     This is tested in a three group design with a control group and two groups receiving healing     with or without a healer present. The study is randomized and double blind.   "
237600|NCT00967408|"     Rehabilitative treatment in stroke survivors has shown to be effective in improving     functional outcome and reducing dependency. Plasticity of the central nervous system, along     with coping strategies and adaptations, seems to play a key role in functional recovery. Some     data support the hypothesis that drug which improve dopaminergic, serotoninergic and     noradrenergic transmission in the central nervous system could improve recovery in stroke     patients. In this population, antidepressants as selective serotonin reuptake inhibitors     (SSRI) are associated to better outcomes, as evidenced by small clinical trials. However,     since depression is a common consequence of stroke, observed improvements could be biased by     the action of these drugs on depressive symptoms, thus improving participation in     rehabilitative treatment.      The hypothesis of this study is that SSRI could improve functional outcome in stroke     survivors not only because of their action on depressive symptoms, but mainly because of a     direct effect on neural repair and neuronal growth.      The aim of the study is to evaluate the effect of a SSRI, escitalopram, on functional outcome     of stroke patients.   "
237601|NCT00967421|"     The purpose of the validation study is to develop a valid test battery for assessing driving     ability in a driving simulator when influenced by drugs. Ethanol has known, well-documented     and well-characterized effects on driving behaviour and accident risk, and will be used to     assess the simulator test scenarios' sensitivity to drug effects. Once the test scenarios     have been refined and their ability to predict driving accident risk have been validated, we     plan to use the simulator to assess driving ability under the influence of different drugs     suspected to produce driving impairment.   "
237602|NCT00967434|"     Patients undergoing non-cardiac surgery frequently experience perioperative cardiac     complications that may be due to excess inflammatory reactions. Lipid lowering drugs called     HMG-CoA reductase inhibitors or statins, have anti-inflammatory effects. Although favourable     evidence suggests these drugs could also prevent perioperative cardiac complications,     definitive evidence of anti-inflammatory effects and benefit is lacking. The purpose of this     study to measure the impact of a atorvastatin on patients undergoing surgery. It will attempt     to determine the speed of drug effect as measured by the impact the drug has on the levels of     the inflammatory mediator called C-reactive protein after surgery. It is hypothesized that     the perioperative use of atorvastatin will safely reduce the postoperative rise in CRP levels     at 48 hours after elective vascular surgery. This effect, would then translate into a     reduction of adverse perioperative complications including reduction in postoperative     myocardial ischemia episodes (as measured through Holter monitoring).   "
237603|NCT00967447|"     Open, prospective, uncontrolled, observational cohort study.   "
237604|NCT00967460|"     The purpose of the study is to evaluate the effect of a project promoting unstructured     spontaneous physical activity (PA) through an adaptation of the built environment and the     provision of a supportive social environment of childcare centers on motor skills, physical     activity, desire to move around, body mass index (BMI), quality of life and PA and behavior     of the family.   "
237605|NCT00967473|"     The purpose of this study is to describe rates of spatial distortions related to intraocular     lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when     implanted bilaterally into the capsular bag following phacoemulsification in adult patients     with bilateral cataract and regular corneal astigmatism. Subjects were implanted with the     Model SN60T9 in the first operative (study) eye and either Model SN60T9 or Model SN60T8 in     the second operative eye.   "
237606|NCT00967486|"     The project involves prospectively randomizing patients to either routine carotid shunting or     selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA)     to see the difference in post-op complications and occurence rates. Patients will be     randomized to Routine shunt vs selective groups.   "
237607|NCT00967499|"     The purpose of this study is to investigate palonosetron versus ondansetron as rescue     medication in subjects that develop postoperative nausea and vomiting (PONV) in the     Postanaesthesia Care Unit (PACU).   "
238086|NCT00959036|"     The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered     to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a     stable dose and route of methotrexate.   "
237608|NCT00967512|"     The purpose of this study is to assess whether treatment with cenersen in combination with 4     cycles of high and low-dose chemotherapy (idarubicin and cytarabine) improves the complete     response rate in acute myelogenous leukemia (AML) patients ≥ 55 years of age who did not show     a response (CR, CRi, or PR) to a single aggressive frontline induction course.   "
237609|NCT00967525|"     In this trial the investigators seek to determine if injecting cord blood cells directly into     the bone marrow (intraosseous injection), rather than infusing them intravenously, can     improve engraftment. The rational for doing this is that most hematopoietic stem cells (HSCs)     infused intravenously never reach the bone marrow, getting trapped by other organs, such as     the lungs, instead. The potential advantage of intraosseous infusion is suggested by studies     in rodents that have demonstrated that in HSC transplants where the cell dose is limiting     intraosseous injection is a more effective route of administration. The safety of     intraosseous injections, in general, is underscored by the vast experience using intraosseous     injections for resuscitation of critically ill children. The safety of injecting HSCs     intraosseously has been demonstrated in a clinical trial of transplanting bone marrow cells.      To safeguard against problems that might result, if intraosseous infusion fails to improve     engraftment in this trial, the investigators will integrate a recently introduced strategy     proven to improve engraftment-the transplantation of two cord blood units. Transplanting two     unrelated cord blood units by intravenous infusion has been shown to improve engraftment     (although there is still room for improvement). In this trial one unit will be injected     intraosseously and the other unit will be infused intravenously.      This study is being conducted as a forerunner to a larger, multi-center trial. The     investigators intend to enroll five patients over 1-2 years.   "
237610|NCT00967538|"     The purpose of this study is to evaluate safety and efficacy of etanercept in patients with     psoriasis who had an unsatisfactory response to adalimumab and infliximab.   "
237611|NCT00967551|"     Diarrheal diseases are a major cause of morbidity and mortality globally in children less     than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in     developing countries are usually a consequence of micronutrient deficiencies including zinc.     The primary aims of the proposed study are to evaluate the effect of the use of multiple     micronutrient sprinkles including zinc on compliance of supplement use and the incidence of     recurrent diarrheal and respiratory illnesses. The proposed study will be conducted at the     Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da     Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind     placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group     of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into     2 groups of 60 children each. The intervention group will receive sprinkles containing zinc     while the control group will receive micronutrient sprinkles without zinc. The primary     outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both     groups of infants will be monitored at monthly intervals for an initial duration of 180 days     for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for     the establishment of a cohort of children who will be monitored in a micronutrient     supplementation trial using sprinkles.   "
237612|NCT00967564|"     The purpose of this study is to evaluate the correlation between quality of life (QoL) and     hemoglobin in patients affected by myelodysplastic syndrome and to compare the MDS     (MyeloDisplastic Syndrome) patient's self-assessed QoL according to physician's evaluation   "
237613|NCT00967577|"     The purpose of this study is to evaluate changes in tumor blood flow and disease response to     the investigation agent, 177Lu-J591.   "
237614|NCT00967590|"     This randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety     and tolerability of RO5036505 in patients with inadequately controlled moderate to severe     asthma. Patients will be randomized to receive either RO5036505 (380mg iv infusion once     weekly) or placebo for 8 weeks. Patients will be on a standardized inhaled     corticosteroid/long-acting beta-agonist regimen during study treatment. Target sample size is     50-100 individuals.   "
237615|NCT00967603|"     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the     tyrosine kinases needed for angiogenesis and cell growth. It is not yet known whether     sunitinib malate is effective as maintenance therapy in delaying tumor progression in     patients with metastatic pancreatic cancer who are progression-free after 6 months of     induction chemotherapy.      PURPOSE: This randomized phase II trial is studying sunitinib malate as maintenance therapy     to see how well it works compared with observation in avoiding tumor progression after     induction chemotherapy in patients with metastatic pancreatic cancer.   "
237616|NCT00967616|"     This phase 2, randomized, active-controlled, open-label, parallel group, multicenter study     will be conducted at up to 18 study centers in the US, Central America, and South America.     Adult subjects with metastatic colorectal cancer (CRC) who failed first-line chemotherapy     will participate in the study, which will be conducted on an outpatient basis. It is     anticipated that 100 subjects will be enrolled to obtain approximately 90 evaluable subjects.   "
237617|NCT00967629|"     The purpose of this study is to determine whether oral sevelamer carbonate binds advanced     glycation end products (AGEs) in the gastrointestinal (GI) tract of patients with diabetic     nephropathy leading to decrease body AGE load and therefore decreases the inflammation and     oxidative stress in these patients.   "
237618|NCT00967642|"     The purpose of this study is to evaluate the effects of intravenous insulin/24 hours to     normalize glycemia upon markers of oxidative stress (protein oxidation and total antioxidant     defense) and inflammation (C-reactive protein (CRP) and sCD40L) in diabetic patients     submitted to PCI with stent.   "
237648|NCT00968032|"     The foramen ovale is an opening in the interatrial septum. It results from an incomplete     coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis     of the interatrial septum is a clinical finding and is defined as a patent foramen ovale     (PFO). The Nit-Occlud® PFO umbrella is a permanent implant for closing PFOs that is implanted     in the PFO using minimally invasive catheter technology. The umbrella is made from Nitinol, a     material with superelastic properties, which, in its relaxed state, has the form of a double     umbrella. This is a single-center, non-comparative, prospective interventional clinical     investigation involving 1 center in Germany to assess the effectiveness, safety and     practicability of implantation of the Nit-Occlud PFO® Closure Device.   "
237619|NCT00967655|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Radiation     therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy, monoclonal antibody     therapy, and radiation therapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying the side effects of giving capecitabine and     panitumumab together with radiation therapy with or without irinotecan hydrochloride and to     see how well it works in treating patients undergoing surgery for localized rectal cancer.   "
237620|NCT00967668|"     ASPIRE has completed enrollment of patients at the Ann Arbor and Cleveland Medical Centers in     a study that is examining the impact of an innovative approach to weight loss (Aspiring to     Lifelong Health in VA, aka ASPIRE-VA). ASPIRE-VA has 3 key features: 1) lifestyle coaches     who encourage behavior change through a small steps approach; 2) a simplified Stoplight     diet; and 3) user-friendly enhanced pedometers to help participants monitor their physical     activity.   "
237621|NCT00967681|"     The purpose of the study is to evaluate whether Oncoxin, a nutritional supplement, improves     the clinical and ultrasonographic results in comparison with placebo during 24 weeks of     treatment.   "
237622|NCT00967694|"     The purpose of this study is to learn if breathing nitrous oxide (also known as laughing     gas) changes the pressure in a person's eyes. Some patients who need regular eye exams to     measure their eye pressure often need to be put to sleep with medicine in order to complete     the eye exam. Some of these medicines are known to cause changes in a person's eye pressure.     Because of this, such medicines are avoided if the eye doctor needs to measure the patient's     eye pressure. One medicine that is frequently used to put patients to sleep is nitrous oxide.     No one really knows what effect nitrous oxide might have on a persons' eye pressure. The     investigators are interested to see if nitrous oxide causes an increase, decrease, or no     change in eye pressure. The investigators also want to investigate if there is a difference     in the effects of nitrous oxide on eye pressure between males and females. Understanding     these effects of nitrous oxide is important because during such eye exams, the eye doctor     uses the pressure measurements to make important decisions about treatment and surgery     options for the patient.      The investigators hypothesize that the use of inhaled nitrous oxide (N2O) will result in a     decrease in IOP in healthy volunteers.      The investigators aim to determine the magnitude and duration of change, if any, in IOP     caused by inhalation of N2O, and to assess if the gender of the patient has a role in this     effect.   "
237623|NCT00967707|"     The primary objective of this study is to develop a pharmacokinetic (PK) and a     pharmacokinetic-pharmacodynamic (PK-PD) model for gabapentin in patients with neuropathic     pain.      The secondary objectives are to investigate whether adjuvant therapy of venlafaxine or     donepezil contributes to 1) improved analgesic efficacy and 2) improved health-related     quality of life (assessed by the SF-36 questionnaire) in neuropathic pain patients treated     with gabapentin.   "
237624|NCT00967720|"     Poor adherence to appropriate asthma medications is an important risk factor contributing to     high asthma morbidity and mortality in urban African American adolescents. As part of the     ADEPT (Adolescent Disease Empowerment and Persistency Technology) for Asthma Pilot 2 study, a     focus group was developed specifically to explore existing barriers to adherence among inner     city African American adolescent asthmatics.   "
237625|NCT00967733|"     The optimal type of oil to prevent cardiovascular disease (CVD) is uncertain. In general,     unsaturated oils with higher content of cis-monounsaturated fatty acids (MONO) or     cis-polyunsaturated fatty acids (PUFA) are preferable over those rich in saturated fatty     acids. However, unsaturated oils can vary in their relative contents of n-6 and n-3 fatty     acids (specifically alpha-linolenic acid (ALA)). Some investigators advocate that oils rich     in ALA are cardioprotective, while others suggest that optimal cardioprotective effects can     only be obtained when oils are lower in n-6 fatty acids (mainly linoleic acid) in addition to     being higher in ALA. It is hypothesized that increased ALA would result in beneficial effects     on inflammatory markers. The objective of this trial is to establish definitively the     biological effects of ALA with and without reductions in linoleic acid on inflammatory     markers linked to CVD.   "
237626|NCT00967746|"     This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind     trial of three different doses of etonogestrel releasing medicated intrauterine systems     (ENG-MIUS) in healthy parous women in need for contraception.      The primary trial objective is to explore safety and acceptability of three doses of an     ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.   "
237627|NCT00967759|"     The primary outcome of this study is to evaluate the clinical efficacy of the dose fixed     combination and each drug, that composes it, isolated, regarding the respiratory symptoms     improvement in superior air passages acute affection in children between 2 and 6 years old.   "
237628|NCT00967772|"     The safety/tolerability and pharmacokinetics (PK) of Naftopidil (commercial name: Flivas)     after oral administration will be investigated in Korean healthy male volunteers. All     volunteers will be assigned to 2 groups and administered a lower single dose tablet (Period     1). After one week's wash-over period, the volunteers take higher dosages (Period 2).   "
237629|NCT00967785|"     Background:        -  WHIMS (warts, hypogammaglobulinemia, infection, and myelokathexis syndrome) is caused by          various genetic changes that increase the activity of the CXCR4 gene. Excessive function          of this gene causes mature neutrophils (part of white blood cells) to be retained within          the bone marrow rather than being released to the general blood circulation, and is one          of the causes of severe inherited neutropenia (low white blood counts). In neutropenia,          the body is less able to fight off infection. Patients with WHIMS usually are at risk          for skin, soft tissue, sinus, and lung infections, which can result in loss of hearing,          teeth, and lung function.        -  Current treatment for WHIMS consists of regular injections of a white blood cell growth          stimulating medication called granulocyte colony stimulating factor (G-CSF), and monthly          infusions of intravenous immunoglobulin (IVIG). These therapies are expensive,          nonspecific, have significant side effects and toxicities, and do not fully correct all          problems, especially warts and cancers related to human papillomavirus (HPV).        -  A drug called Mozobil has been approved for use in combination with G-CSF to increase          the number of stem cells that can be collected prior to bone marrow transplantation.          Mozobil may offer a specific and well-tolerated new treatment for WHIMS and other          syndromes characterized by neutropenia.      Objectives:        -  To evaluate whether Mozobil is safe and effective to treat neutropenia (low white blood          cell count) in patients with WHIMS.        -  To determine an appropriate treatment dose of Mozobil, within currently approved dosage          levels.      Eligibility:      - Individuals between 18 and 75 years of age who have been diagnosed with WHIMS and have a     history of severe infections.      Design:        -  Potential participants will undergo a screening study, with a medical history, physical          examination, questionnaire, heart and lung function scans, and blood and urine samples.          Tests will also be done for hepatitis B and C virus, and human immunodeficiency virus          (HIV) that causes acquired immunodeficiency syndrome (AIDS), as well as to check          neutrophil function.        -  Patients who are being treated with G-CSF will stop injections for 5 days before being          admitted to the National Institutes of Health (NIH) Clinical Center. While off the          medication, patients will keep a diary to report information about their general          well-being while off the medications and will bring it to NIH when admitted.        -  Patients will be admitted to the NIH Clinical Center inpatient until 2 days before          starting the treatment and will stay for approximately 10 days. Before the treatment,          patients will have blood samples taken regularly.        -  Patients will receive increasing doses of Mozobil over 5 days of treatment until their          white blood cell count improves sufficiently or the maximum approved dose is reached.          Blood samples will be taken regularly throughout the treatment process. Patients will          then receive an additional dose of Mozobil at the maximum approved dose or the dose          sufficient to cause improvement, before restarting the G-CSF injections.        -  Between 4 and 6 weeks after the treatment phase, patients will return to the NIH for an          outpatient study completion and evaluation visit.   "
237649|NCT00968045|"     The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding     and transfusion requirements after coronary artery bypass surgery (CABG) in patients with     endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a     prospective, randomized double-blind placebo-controlled single center study.   "
237677|NCT00960271|"     This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non     small cell lung cancer staging. This controlled multicentric study will be conducted in 22     centers in France. The study design includes two prospective phases. In phase 1, one     investigator in each center will prospectively be evaluated for its ability to perform EBUS,     with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2     will include the medico-economic assessment of the technique in the preoperative setting. A     maximum of 420 patients for each phase is forecasted.   "
237630|NCT00967798|"     Acute systemic hyperglycemia causes oxidative stress and a pro-inflammatory response. The     pro-inflammatory cytokines induced by hyperglycemia are toxic to islet insulin producing     cells, and thus worsen glucose intolerance. Patients with cystic fibrosis (CF) have a high     prevalence of CF related diabetes (CFRD) and up to 40% of CF adults develop CFRD. During the     prediabetic phase in CF, there is progression from normal glucose homeostasis to high risk     prediabetes characterized by episodes of acute hyperglycemia after meals and during     respiratory exacerbations. The mild hyperglycemia seen in CF patients with high risk     prediabetes following a meal would be expected to induce a degree of systemic inflammation     and oxidative stress. These repetitive episodes, if left unchecked, could lead to progression     of glucose impairment, worsening severity of oxidative stress and inflammation, and     ultimately the development of CFRD, all via hyperglycemia-induced toxicity to beta cells.     Furthermore, this process may be accelerated in CF because lung disease and resultant     respiratory exacerbations are associated with oxidative stress and inflammation and this will     further contribute to beta cell damage.      Sitagliptin is a recently approved agent for type 2 diabetes and markedly enhances insulin     secretion in the presence of hyperglycemia and has been shown to be effective in preventing     postprandial hyperglycemia. The hypothesis to be tested in this project is that sitagliptin     will prevent the development of CFRD in CF subjects with high risk prediabetes by blocking     postprandial hyperglycemia. The investigators propose a randomized, double-blind,     placebo-controlled, multicenter, 15-month longitudinal study in 118 CF subjects with high     risk prediabetes to test this hypothesis. Specifically, the investigators aim to show that     chronic treatment with sitagliptin: prevents the conversion to diabetes; results in     preservation of beta cell function; reduces systemic measures of oxidative stress and     inflammation; and slows the rate of progression of lung disease.      Funding Source - FDA Office of Orphan Products Development   "
237631|NCT00967811|"     The purpose of this study is to evaluate the safety and preliminary efficacy of two     formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle     glaucoma.   "
237632|NCT00967824|"     RATIONALE: Evaluating a decision aid that describes the risks and benefits of taking     tamoxifen citrate to prevent breast cancer may be helpful for women at increased risk of     breast cancer.      PURPOSE: This randomized phase I/II trial is studying tamoxifen citrate decision aids for     women at increased risk of breast cancer.   "
237633|NCT00967837|"     One of the significant complications associated with some patients with diabetes is the     inability for wounds to heal regardless of enrolling and participating in a traditional wound     healing program. There have been a number of anecdotal evidence presented by patients     receiving pulsatile intravenous insulin therapy for other complications with non healing     wounds lasting from several months to several years whose wounds healed while receiving     therapy. This study was designed to specifically monitor the progress of diabetic patients     who have failed traditional wound care therapy and monitor the progress of their wounds while     receiving pulsatile intravenous insulin therapy.   "
237634|NCT00967850|"     The purpose of this study is to determine the efficacy and safety of intravitreal injections     of bevacizumab in High Myopia´s choroidal neovascularization versus the standard treatment of     Photodynamic therapy.   "
237635|NCT00967863|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more     tumor cells and cause less damage to normal tissue. It is not yet known which dose of     radiation therapy is more effective in treating patients with prostate cancer.      PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in     treating patients with prostate cancer receiving hormone therapy.   "
237636|NCT00967876|"     The investigators aim at analyzing the diagnostic accuracy of 320-row CT for coronary stents.   "
237637|NCT00967889|"     RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors find better ways to treat the cancer.      PURPOSE: This research study is looking at tissue, blood, and urine samples from patients     with advanced prostate cancer.   "
237638|NCT00967902|"     To demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting     Stent (Combo Stent) compared to the Taxus® Liberté® Stent in the treatment of coronary artery     lesions.   "
237639|NCT00967915|"     The purpose of this study is to determine if frenotomy for ankyloglossia will improve infant     breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the     hypothesis that frenotomy will do all of the above.   "
237640|NCT00967928|"     This Phase 1, single-site, dose-escalation study is being conducted to determine the maximum     tolerated dose (MTD) of RAD001 as part of a specified combination regimen.   "
237641|NCT00967941|"     This study prospectively selects the patients to examine the effectiveness of the     investigators' current standard of prophylaxis prior to vascular surgery and to compare the     effectiveness of vancomycin and daptomycin plus cefazolin in reducing infections in vascular     surgical patients.   "
237642|NCT00967954|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at blood and tissue samples from patients with     prostate cancer receiving androgen deprivation therapy.   "
237643|NCT00967967|"     Many patients suffering from allergic rhinitis do not recognize or perceive their symptoms.     Instruments have been developed to assess quality of life in rhinitis, asthma or both, but     there is a need to develop validated tools or methods to assess rhinitis control among     rhinitis and/or asthmatic patients. The aim of this study is to assess the discriminative and     evaluative properties of the RCSS in asthmatic patients with allergic rhinitis.   "
237644|NCT00967980|"     The purpose of this research study is to determine if the insertion site of a perineural     catheter, or tiny tube placed next to the nerves that go to the hip which you will have     surgery, affects the amount of pain relief that is experienced after surgery.   "
237645|NCT00967993|"     The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a     dietary phosphate binder in controlling and managing serum phosphorus levels in patients with     end-stage renal disease (ESRD).   "
237646|NCT00968006|"     Endothelial progenitor cells (EPCs) are involved in cardiovascular homeostasis, through     angiogenesis and endothelial healing. Diabetic patients have a high risk of cardiovascular     events and low levels of circulating EPCs.      Sitagliptin is an oral DPP-IV antagonist, approved for the treatment of type 2 diabetes. It     increases the bioavailability of endogenous incretins, thus improving insulin and glucagon     secretion. SDF-1, one of the major EPC regulators, is also a substrate of DPP-IV. This study     tests the hypothesis that sitagliptin increases the levels of circulating EPCs in type 2     diabetic patients.   "
237647|NCT00968019|"     The purpose of this study is: To evaluate the safety and performance of the Presillion stent     in routine clinical practice.   "
237650|NCT00968058|"     Children and adults frequently need a 'breathing tube' when having anesthesia for surgery.     The breathing tube is usually inserted after the anesthesia doctor puts a patient to sleep     with medicine, so they do not feel the breathing tube. In children, there is often a leak of     air between the tube and the windpipe, as the tube is not an exact fit. Anesthesia doctors     usually listen for this leak around the tube by listening to the chest with a stethoscope     while gently filling the lungs with oxygen from the anesthesia machine. The leak tells them     if the tube is the correct size, or too small, or too tight. If it is too small, or too     tight, they usually change the tube for a better fit.      The purpose of this study is to see what happens to this leak in the 30 minutes after the     tube is placed. No one really knows if the leak gets bigger, smaller, or stays the same.     Knowing what happens to the leak will help anesthesia doctors to decide whether to change the     breathing tube or not. This is important, as a tube that is too tight can lead to breathing     difficulty after removing the tube at the end of surgery, and a tube that is too small may     make it difficult for the breathing machine to work effectively for the patient as a result     of a large leak of air or oxygen.   "
237651|NCT00968071|"     The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine     (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or     high-risk MDS. The safety of this drug combination will also be studied.   "
237652|NCT00968084|"     Background:        -  For every CHI research study, patients must fulfill a list of criteria, based primarily          on their medical condition. To determine whether a patient meets these eligibility          criteria to participate in a research protocol, researchers must perform a series of          diagnostic tests and procedures.        -  These evaluations are designed to evaluate a participant s general medical condition          (i.e., blood tests, function of certain organs such as the lungs, heart, liver, or          kidneys), and to confirm a diagnosis or ensure that a healthy volunteer is in good          condition. They maximize the safety for the patients and healthy volunteers at CHI.      Objective:      - To determine the eligibility of patients and healthy volunteers for active CHI research     protocols.      Eligibility:        -  The procedures included in this protocol will determine eligibility for active CHI          research protocols.        -  Both healthy volunteers and patients will be evaluated.      Design:        -  Required tests and procedures for various research studies may include the following:          history and physical examination, blood and urine tests, lung and heart function tests          (echocardiogram, electrocardiogram, stress test), imaging studies (X-rays, magnetic          resonance imaging (MRI), computerized tomography (CT), and tissue collection.        -  Participants will be asked to undergo tests only for the study or studies for which they          are being considered. The research team will provide further information on any          additional tests that may be required.        -  After all eligibility assessments are complete, participants may be offered          participation in one or more CHI research protocols or referred back to a home          physician.   "
237653|NCT00968097|"     The main objectives of this proposal are as follows:      To assess the dynamic uptake and washout of 123-I MNI-340, a potential imaging biomarker for     β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in     similarly aged Alzheimer's (AD) subjects and healthy controls      To perform blood metabolite characterization of 123-I MNI-340 in healthy and AD subjects to     determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-340 as a     single photon computed tomography (SPECT) brain imaging agent   "
237654|NCT00968110|"     This is a pilot feasibility study, using Xolair pretreatment for oral milk desensitization.     The major assessment will be safety, and the investigators will evaluate for any type of     reaction, including allergic reactions that occur during the course of the study.   "
237655|NCT00968123|"     The Purpose of this study is to report a new single portal endoscopic release technique and     the sequence of the first 50 patients who underwent this release.      This will be a chart review of the demographics, outcomes, and complications of a sequential     series of patients undergoing a Seg-Way Endoscopic carpal tunnel release (ECTR).   "
237656|NCT00968136|"     This is a randomized, controlled study to compare Short-term ketogenic diet with conventional     long-term trial in refractory infantile spasms.   "
237657|NCT00968149|"     This study will evaluate the effect of montelukast compared to placebo in children during the     spring allergic rhinitis season.   "
237658|NCT00968162|"     Most bone marrow transplants for children with sickle cell disease are performed using high     doses of two chemotherapy agents: busulfan and cyclophosphamide for the pre-transplant     conditioning. This approach produces cure in most cases (approximately 95%). It, however, has     serious side effects, including seizures and infertility. The primary goal of this study is     to determine how much we can lower the dosages of busulfan and cyclophosphamide by     incorporating fludarabine, a safer chemotherapy agent, into conditioning. The secondary goal     is to develop a better understanding of how bone marrow transplants cause neurologic problems     like seizures.   "
237659|NCT00968175|"     The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis     (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to     decreasing the severity of abdominal pain when compared to analgesic therapy alone.   "
237660|NCT00968188|"     The purpose of this study is to develop an empirically validated, scientifically-based HIV     and STI prevention program that can be delivered online to young men who have sex with men     (YMSM) who were recently tested for HIV.   "
237661|NCT00968201|"     A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and     placebo administered once daily at bed time.   "
237662|NCT00968214|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients will respond to     treatment.      PURPOSE: This research study is looking at tumor and blood samples from postmenopausal women     with primary breast cancer enrolled on clinical trial CAN-NCIC-MA27.   "
237663|NCT00968227|"     The purpose of this study is to determine if giving blood transfusions to anemic patients     with subarachnoid hemorrhage will reduce their chances of having a stroke from vasospasm.   "
237664|NCT00968240|"     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of     tumors also exhibits the most aggressive behavior, resulting in median overall survival     durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of     either surgical resection, external beam radiation or both. All patients experience a     recurrence after first-line therapy, so improvements in both first-line and salvage therapy     are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently     used intravenous (IV) therapies even cross the blood brain barrier (BBB). Superselective     Intraarterial Cerebral Infusion (SIACI) is a technique that can effectively increase the     concentration of drug delivered to the brain while sparing the body of systemic side effects.     One currently used drug called, Bevacizumab (Avastin) has been shown to be active in human     brain tumors but its actual CNS penetration is unknown. This phase I clinical research trial     will test the hypothesis that Bevacizumab can be safely used by direct intracranial     superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival     of patients with relapsed/refractory GBM/AA. By achieving the aims of this study we will     determine the toxicity profile and maximum tolerated dose (MTD of SIACI Bevacizumab. We     expect that this project will provide important information regarding the utility of SIACI     Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to     our patients in the near future.   "
237665|NCT00968253|"     The goal of Phase I of this clinical research study is to find the highest tolerable dose of     RAD001 (everolimus) when given in combination with the standard chemotherapy regimens to     patients with ALL.      The goal of Phase II of this study is to learn if the drug combinations can help to control     ALL. The safety of these drug combinations will be also studied in both phases.   "
237666|NCT00968266|"     The purpose of this study is to determine if a short motivational patient-centered     intervention for non-adherent patients is more successful in improving beliefs about     medication (and adherence) compared to a usual care control group of non-adherent patients.   "
237667|NCT00968279|"     The primary objective of this study is to analyze the diagnostic accuracy of coronary CT     angiography using 320 simultaneous detector results in patients with atrial fibrillation.   "
237668|NCT00968292|"     The investigators are currently verifying early data showing that the K3 Promoter prosthetic     foot affects walking efficiency or stability in transtibial, unilateral amputees when     compared to their current prostheses. Phase II funds are being used to address these metrics.     These studies are important basic research, however, while Tensegrity has the unique     opportunity to study amputee gait and movement in the CGMA's state-of-the-art facility the     investigators will expand these studies with BRDG-SPAN funding by studying the following     metrics:        1. Four Square Step Test (FSST)        2. Amputee Mobility Predictor (AMP)        3. Timed Up and Go Test (TUG)        4. Quality of life (QOL) index (SF-36)        5. Activity-specific Balance Confidence Questionnaire (ABC)        6. 3D motion analysis   "
237669|NCT00968305|"     Asthma is a very common childhood chronic illness and is generally more severe in African     Americans. The investigators attempted to determine whether a specific immune marker is     associated with lung function and asthma severity.   "
237670|NCT00968318|"     Tissue expansion has enjoyed a wide range of applications since the technique was popularized     in the latter quarter of the last century. During the expansion process, subcutaneous fat     liquefies, skin becomes thinner, muscles atrophy, blood inflow increases, and lymphatics get     occluded. All these factors predispose to seroma formation and implant extrusion.      A similar problem occurred with lymphoedema patients, and one of the lines of treatment was     creation of a connection to the deep lymphatics to facilitate absorption of accumulated     fluid. The same principle is to be extrapolated to patients having tissue expanders inserted     in the neck and limbs and its effect is to be noted on the incidence of seroma .   "
237671|NCT00968331|"     Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days     with 7 days rest (28 day cycle) for a total of 4 cycles. Rituximab is administered on day 1     and day 21 of each cycle at the dose of 375 mg/m2 for a total of 4 cycles.      After this induction phase, the CR, PR and SD will continue Lenalidomide with the same     schedule for other 8 months.   "
237672|NCT00968344|"     The investigators will test the following hypotheses:        1. Bedrest will blunt the anabolic response to a mixed nutrient meal, facilitating a loss          of muscle mass and functional capacity that is only partially restored during          rehabilitation.        2. Enriching daily meals with leucine will promote protein synthesis and maintain the          anabolic response to mixed nutrient meal ingestion. This will preserve lean muscle mass          and function during bedrest and facilitate the recovery of functional and metabolic          capacity during rehabilitation.   "
237673|NCT00960219|"     Adjuvant N-methyl-D-aspartic acid (NMDA)-enhancing agents, such as GlyT-1 inhibitors and     NMDA-glycine site agonists have been demonstrated to be beneficial for chronic schizophrenia     patients. The purpose of this study is to evaluate efficacy and safety of add-on treatment of     an inhibitor of D-amino acid oxidase (DAAOI), DAAOI-1, in chronically stable schizophrenia     patients who have been stabilized with antipsychotics.   "
237674|NCT00960232|"     There are numerous indications for a relation between low serum levels of 25(OH)D and blood     pressure, lipid levels, frequency of infections and tendency towards depression. Whether it     is a causal relationship it is not known, and can best be studied with a vitamin D     intervention. The investigators hypothesis is that supplementation with a high dose vitamin D     (40.000 IU per week) will have a beneficial effect on these parameters.   "
237675|NCT00960245|"     The purpose of this study is to demonstrate the relative bioavailability of Nadolol (1 x 80     mg) tablets under fasting conditions.   "
237676|NCT00960258|"     This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg     once daily administered orally as a single agent in Japanese patients with advanced solid     tumors.   "
237705|NCT00960648|"     The objective of this study is to evaluate the safety and long-term effectiveness of coronary     stenting with the everolimus-eluting stent (EES) and to determine clinical device and     procedural success during commercial use of EES in the real world.      The investigators will compare EES (Xience/Promus, prospective arm) with sirolimus-eluting     stent (SES, Cypher, retrospective arm).   "
237678|NCT00960284|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin,     epirubicin hydrochloride, fluorouracil, and capecitabine, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether     gemcitabine hydrochloride is more effective when given alone or together with combination     chemotherapy and radiation therapy in treating patients with pancreatic cancer.      PURPOSE: This randomized phase II/III trial is studying gemcitabine hydrochloride to see how     well it works when given alone or together with combination chemotherapy and radiation     therapy in treating patients with stage IB, stage II, or stage III pancreatic cancer.   "
237679|NCT00960297|"     The rationale for this multicenter, phase II trial is to examine the impact of     carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage     IB (> 4.0 cm), II, and select stage III NSCLC. If this novel regimen proves to be safe and     active in this setting, this would provide rationale for further investigation in a larger,     prospective, randomized setting.   "
237680|NCT00960310|"     The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50     mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.   "
237681|NCT00960323|"     Colchicine is a substrate for cytochrome P450 3A4 (CYP3A4). In-vitro studies have indicated     that the ortho-and para-hydroxylated metabolites of atorvastatin may be CYP3A4/5 competitive     and mechanism-based inhibitors (MBI). This study will evaluate the effect of multiple doses     of atorvastatin on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A     secondary objective is to evaluate the safety and tolerability of this regimen in healthy     volunteers. All study subjects will be monitored for adverse events throughout the study     period.   "
237682|NCT00960336|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing.      PURPOSE: This phase II trial is studying how well doxorubicin hydrochloride liposome works as     first-line therapy in treating older women with metastatic breast cancer.   "
237683|NCT00960349|"     The primary objective of the study is to assess the safety and tolerability of cediranib in     combination with Cisplatin plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese patients     with previously untreated locally advanced or metastatic unresectable gastric cancer (GC).   "
237684|NCT00960362|"     This trial is conducted in North America. The aim of this clinical trial is to investigate     the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses     of AGS-009 in patients with systemic lupus erythematosus (SLE).   "
237685|NCT00960375|"     The investigators have developed an intervention called Behavioral Treatment of Smoking     Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and     education with contingency management and a multifaceted behavioral group treatment program     that lasts for three months (24 group meetings). BTSCS is designed to address the cognitive,     motivational, and social support problems characteristic of people with SPMI.      The investigators propose to conduct a randomized trial for persons with SPMI that compares     (1) BTSCS: a 6-month manualized smoking cessation program adapted from an effective substance     abuse treatment program for this population to (2) StSST: a standard manualized smoking     cessation program which reflects current best practices.   "
237686|NCT00960401|"     The purpose of this study is to compare plaque burden in the coronary and carotid arteries 5     years after adjuvant radiotherapy in women with right sided breast cancer vs left sided     breast cancer.   "
237687|NCT00960414|"     The purpose of this study is to compare two approaches to a diet and exercise-based weight     loss program.   "
237688|NCT00960427|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients respond to     treatment.      PURPOSE: This phase I trial is studying biomarkers in tumor tissue and blood samples from     patients undergoing chemotherapy and radiation therapy for stage II or stage III rectal     cancer that can be removed by surgery.   "
237689|NCT00960440|"     This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients     taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor     treatment.   "
237690|NCT00960453|"     The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of     sitagliptin in healthy volunteers.   "
237691|NCT00960466|"     The diagnosis and treatment of cancer has been shown to lead to very high levels of distress     among patients. Although treatments for a range of different cancers have become much better     in recent years, the distress that accompanies diagnosis and treatment can have serious     negative effects for patients. Research has shown that, for a number of reasons, patients     find it difficult to inform healthcare professionals about the cause of their distress     whether it is physical (e.g. pain), psychological (anxiety and depression), personal partners     and family) or social (finances). Also, medical staff often fail to detect even high levels     of distress. This means that a great deal of distress is not being treated and this may lead     to more hospital and GP visits, and dissatisfaction with care. The Distress Thermometer and     Problem List (DT&PL) is a simple method of identifying distress in cancer patients using the     familiar image of a thermometer. It offers patients a list of common treatment-related     difficulties to help them identify any problems that cause distress. A trained staff member     uses the DT&PL to discuss with the patient different options for addressing each concern:     directly where possible (action taken by the patient or the staff member present) or leading     to a referral to a specialist where necessary. Our research aims to measure whether the DT&PL     is effective in quickly identifying and treating cancer-related distress and therefore     preventing longer-term problems developing. The investigators also want to know whether     patients find it helpful to complete the DT&PL and whether using the DT&PL saves NHS time and     money.   "
237692|NCT00960479|"     The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200     capsules and Rebetol 200 mg capsules in females under fasting conditions.   "
237724|NCT00960895|"     This is a descriptive study of patients with Lymphangioleiomyomatosis and precapillary     pulmonary hypertension.   "
237693|NCT00960492|"     The purpose of this study is to determine the highest safe dose of XL184 administered orally     in combination with temozolomide (TMZ, Temodar®) and radiation therapy (RT). XL184 is a new     chemical entity that inhibits VEGFR2, MET, and RET, kinases implicated in tumor formation,     growth and migration. Temozolomide (TMZ, Temodar®) is an orally administered alkylating     agent. It is approved by the Food and Drug Administration (FDA) for the treatment of newly     diagnosed glioblastoma (GB) patients when given in combination with radiation therapy (RT)     followed by maintenance treatment. First-line treatment for patients with GB consists of a     concurrent phase (6-7 weeks in duration) during which TMZ is given with RT, followed by a     rest phase (4 weeks in duration; to allow for recovery from delayed toxicity, if present),     and a maintenance phase, during which patients receive TMZ for approximately twelve 28-day     cycles. To determine the highest safe dose, subjects will receive different amounts of XL184     at different times according to the phase of TMZ and radiation therapy. The first group of     subjects will receive the lowest dose of XL184. As long as no medically unacceptable side     effects are noted, the dose will be increased for the next group. If the dose is not     well-tolerated by the first group of subjects, the dose will be lowered for the next group.   "
237694|NCT00960505|"     The proposed research will demonstrate that alternate day modified fasting (ADMF) is a     suitable alternative to daily calorie restriction (CR) for weight loss, weight maintenance,     and heart disease prevention. Since many overweight and obese individuals find it difficult     to adhere to daily CR, this diet option may improve adherence with these dietary restriction     protocols. This, in turn, will allow a greater percent of the overweight and obese population     to lose weight, maintain weight loss, and prevent future occurrences of coronary heart     disease.   "
237695|NCT00960518|"     Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies in China, and     approximately 90% of the patients with HCC are also infected with hepatitis B virus (HBV).     For patients with unresectable disease, the goal of palliative treatment is to control     symptoms and prolong survival. Transarterial chemoembolization (TACE) using iodized oil and     chemotherapeutic agents combines the effect of targeted chemotherapy with that of ischemic     necrosis induced by arterial embolization. It can be administered repeatedly and can prolong     survival in patients with unresectable hypervascular HCC. The long-term prognosis, however,     remains guarded because of frequent development of locoregional tumor recurrence, which,     together with concomitant hepatic decompensation, is the main cause of death. Adefovir works     by blocking reverse transcriptase, an enzyme that is crucial for the hepatitis B virus (HBV)     to reproduce in the body. Based on these results, the investigators conducted a randomized     controlled trial to test the hypothesis that adefovir treatment would reduce or postpone the     recurrence rate and improve the overall survival rate in patients after TACE treatment of     HBV-related unresectable HCC.   "
237696|NCT00960531|"     The purpose of this study is to assess the long term safety, tolerability, and immunogenicity     of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate     Alzheimer's disease.   "
237697|NCT00960544|"     The goal of this clinical research study is to find out how gene expression (as well as how     often this expression occurs) in patients with breast cancer affects how Xeloda®     (capecitabine) is cleared (passed through the urine) from the body. The safety of     capecitabine will also be studied.   "
237698|NCT00960557|"     The purpose of this study is to determine the safety and tolerability of OXi4503 in subjects     with relapsed or refractory carcinomas with hepatic tumor burden.   "
237699|NCT00960570|"     Efavirenz is predominantly metabolized by cytochrome P450 (CYP) 2B6. Fenofibric Acid is an     inhibitor of CYP 2B6. This study will evaluate the effect of multiple doses of fenofibric     acid at steady-state on the pharmacokinetics of single-dose efavirenz in healthy adult     subjects.   "
237700|NCT00960583|"     The purpose of the study is to compare, after functional multidisciplinary rehabilitation for     chronic low back pain, an exercise program to the routine follow-up which is simply to advice     patients to exercise regularly at home. The exercise program should help patients stay     active, which should translate into a better long term quality of life and decreased days off     work.   "
237701|NCT00960596|"     Under environmental intervention programs, to explore the associations between Environmental     Tobacco Smoke (ETS) and changes of pulmonary function, cytokines and new-onset asthma between     different groups.   "
237702|NCT00960609|"     The search for communicating veins (CVs) between adjacent hepatic veins (HVs) has drawn its     rationale from living donor liver transplantation (LDLT). Parenchymal sparing procedures     although HVs are resected suggest that probably their presence is underestimated.      Taking profit from new improvements in ultrasound technology the investigators aim to better     estimate the rate of CVs in a consecutive series of patients in whom resection of one HV at     caval confluence is needed.   "
237703|NCT00960622|"     Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to     switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on     Combivir or on trizivir. Measurements will be performed at baseline and after 6 months after     randomization to either continuing on trizivir or combivir, or to switching to Truvada.     Measurements include maximal or peak oxygen consumption, lactate production and clearance,     subcutaneous adipose tissue and limb fat contents, insulin resistance, liver and muscle fat     contents, and plasma free fatty acid concentrations. The hypothesis underlying this study is     that chronic therapy with thymidine analogue nucleoside reverse transcriptase inhibitors     (NRTIs), including zidovudine (AZT), leads to clinically detectable mitochondrial dysfunction     in several organ systems.   "
237704|NCT00960635|"     This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the     daily intake of 1,25-dihydroxy-vitamin D3 [1,25(OH)2D3], improves beta cell function in     patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral     administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time     without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed     meal tolerance test are measured at the beginning of the study, as well as at the end of the     treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no     difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at     month 18.   "
237706|NCT00960661|"     The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a     day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine     (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects     with Type 2 Diabetes Mellitus who have inadequate glycemic control.   "
237707|NCT00960674|"     Tactile massage is a gentle form of massage that probably exerts its effect through     relaxation. In a pilot study of 11 subjects an effect on HbA1c of 0.8%-units was seen.      The study aimed at comparing the effect of tactile massage sessions for one hour given once a     week for 10 weeks in comparison with relaxation through a relaxation CD performed once a week     during 10 weeks. Primary outcome was HbA1c measured after completed intervention and after     yet another 12 weeks. Secondary outcomes were quality of life by SF-36, other markers of     metabolism (fasting glucose, insulin resistance by HOMA-model), inflammation (CRP, cytokines)     and stress (cortisone, catecholamines).   "
237708|NCT00960687|"     This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145     mg fenofibrate tablets in healthy volunteers when administered following a breakfast of     standard composition. Safety and tolerability of this regimen will also be evaluated.   "
237709|NCT00960700|"     A multi-centre non-randomized clinical investigation to assess multifocal visual outcomes     using different near additions, for the treatment of aphakia after cataract removal.   "
237710|NCT00960713|"     The primary purpose of the study is to describe by a prospective observational study the     serious adverse events occurring in patients treated off-label by rituximab for various     auto-immune diseases.   "
237711|NCT00960726|"     The goal of this clinical research study is to learn if NOV-002 can help to restore bone     marrow and blood levels in patients who have MDS. The safety of this drug will also be     studied.   "
237712|NCT00960739|"     RATIONALE: Radioactive drugs, such as iodobenzylguanidine meta-I131, may carry radiation     directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as     topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. A stem cell transplant may be able to     replace the cells that were destroyed by iodobenzylguanidine meta-i131 and topotecan     hydrochloride.      PURPOSE: This phase II trial is studying the side effects of iodobenzylguanidine meta-I131     given together with topotecan hydrochloride and to see how well it works in treating young     patients with refractory or relapsed metastatic neuroblastoma.   "
237713|NCT00960752|"     The goal of this clinical research study is to learn if the vaccines, gp100(g209-2M), and     MAGE-3, when given in combination with resiquimod (R848), can help to stimulate the immune     system against melanoma.   "
237714|NCT00960765|"     This research project is designed to investigate endotoxin (a toxin present in the wall of     certain kinds of bacteria) levels and the type of bacteria present in the intestine before     and after Roux-en-Y gastric bypass or gastric banding surgery in patients that meet the     classification for morbid obesity (body mass index >40 kg/m2) and type 2 diabetes. It is     known that the type of bacteria present in the intestines of normal weight and obese     individuals are different, and it is also known that people with obesity and type 2 diabetes     have higher levels of endotoxin. It has been shown that the bacteria change over the long run     after Roux-en-Y gastric bypass surgery, but the short-term effects are not known and the     endotoxin levels after this procedure have never been studied.   "
237715|NCT00960778|"     This study will investigate the underlying neurobiology of differences between male and     female smokers. Research suggests that women are less responsive to nicotine replacement     therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking.     This study proposed that male smokers will have a greater response to NRT demonstrated by     reduced withdrawal symptoms, craving, and less blood-oxygen-level dependent functional     magnetic resonance imaging (BOLD FMRI) regional brain activation in response to nicotine-cues     as compared to female smokers treated with NRT. Additionally, female smokers will have a     greater response to denicotinized cigarettes with decreased withdrawal symptoms, craving, and     less BOLD fMRI activation in response to nicotine-cues as compared to male smokers.   "
237716|NCT00960791|"     The purpose of the study is to evaluate the absorption, distribution, metabolism and     excretion of AZD1656 after administration of a single oral dose of 14C-labelled AZD1656     solution in male Type 2 Diabetes Mellitus patients.   "
237717|NCT00960804|"     Tanezumab, administered for up to 1 1/2 years, reduces the pain of osteoarthritis without     affecting how nerve impulses are transmitted in sensory nerves   "
237718|NCT00960817|"     The investigators will investigate patients undergoing coronary angiography with normal     coronary but slow blood flow that was normalized after adenosine injection into the coronary     artery. The investigators believe that they have small vessel coronary disease which is the     initial presentation of coronary disease prior to anatomical narrowing. To alleviate this     phenomenon the investigators intend to examine the long-term clinical response of these     patients to treatment with dipyridamole, a well-known medication with almost no side-effects     that increases the level of adenosine in the tissue.   "
237719|NCT00960830|"     The purpose of this study is to evaluate if the use of antidepressant medication in depressed     patients with implantable cardioverter defibrillator reduces the number of ICD's shocks as it     improves depressive affect.   "
237720|NCT00960843|"     The purpose of this protocol is to determine how band fill volumes that are based on     intraband pressure readings can influence the comfortability of the band and to compare     weight loss with this methodology to weight loss with the conventional approach recommended     in existing product labeling.   "
237721|NCT00960856|"     The primary objective of this study is to characterize the single-dose pharmacokinetic     profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat     compositions on the rate and extent of absorption. Additionally, the safety and tolerability     of this dose and regimen of fenofibric acid will be evaluated.   "
237722|NCT00960869|"     Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for     developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.   "
237723|NCT00960882|"     The purpose of this study is to determine the gastric tolerability and the pharmacokinetics     of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers.   "
237725|NCT00960908|"     The objective of this study is to evaluate the safety and long-term effectiveness of coronary     stenting with the zotarolimus eluting stent (ZES) and to determine clinical device and     procedural success during commercial use of ZES.      The investigators will compare 2nd generation ZE (Endeavor resolute, active prospective arm)     with 1st generation ZES (Endeavor Sprint, retrospective arm).   "
237726|NCT00960921|"     Body iron levels may be important in determining how the blood pressure in the lungs changes     in response to low oxygen levels. At high altitude, where oxygen levels are low, some     patients develop elevated lung blood pressure. The investigators hypothesize that, in high     altitude residents with elevated lung blood pressure, iron supplementation will cause a     reduction in lung blood pressure.   "
237727|NCT00960934|"     The purpose of this study was to identify an appropriate dose of      MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal     women with osteoporosis.   "
237728|NCT00960960|"     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,     tolerability, and pharmacokinetics of oral (PO) pictilisib administered with letrozole or     intravenous (IV) paclitaxel with and without IV bevacizumab or IV trastuzumab in participants     with locally recurrent or metastatic breast cancer. The study consists of three parts. Part 1     (pictilisib will be administered in 21+7 schedule along with paclitaxel and/or bevacizumab),     Part 2 (pictilisib will be administered in 5+2 schedule along with paclitaxel and/or     bevacizumab or trastuzumab) and Part 3 (pictilisib will be administered in combination with     letrozole). Part 1 and Part 2 consists of two stages; a dose escalation stage and a     cohort-expansion stage.   "
237729|NCT00960973|"     The purpose of this study is to test whether vitamin K supplementation has an effect on     glucose metabolism in terms of acute beta cell response.   "
237730|NCT00960986|"     The purpose of this study is to assess nausea severity in response to four different drug     dosing strategies of Duloxetine (30 mg with food, 60 mg with food, 30 mg without food, and 60     mg without food) in Korean patients with major depressive disorder (MDD).   "
237731|NCT00960999|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more     tumor cells and cause less damage to normal tissue. It is not yet known which regimen of     stereotactic body radiation therapy is more effective in treating patients with non-small     cell lung cancer.      PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy     regimens and to see how well they work in treating patients with stage I non-small cell lung     cancer.   "
237732|NCT00961012|"     Older adults with a disability tend to spend greater periods of time in bed each day and     often over a mealtime. To make it safe for them to eat in bed, the patient is placed in a     high Fowler's position. This means that the head and the foot of the bed are raised to sit     the person up.      Sitting up in bed increases pressure over the buttocks which can lead to the development of a     pressure ulcer. The purpose of this study is to evaluate the impact of the positional change     called the trunk release on pressure over the buttocks, on breathing and on comfort.      Primary Hypothesis - Performing the trunk release with an older adult population at low risk     for pressure ulcer will result in a 5mmHg decrease in the peak pressure index over the     sacral-coccygeal area as measured by the peak pressure index using a Force Sensitive     Applications (FSA) Pressure Mapping System.      Secondary Hypotheses - Performing the trunk release with an older adult population at low     risk for pressure ulcer will result in:        -  Improved ventilation as measured by a 0.5 liter increase in slow vital capacity.        -  Greater comfort as measured by a two point change on a horizontal numeric scale with          word anchors combined with the Wong-Baker faces scale (Appendix D).        -  A four-centimetre displacement of the trunk as it extends up towards the head of the          bed.   "
237733|NCT00961025|"     This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing,     dose-escalation study. The study is designed to describe the relationship between multiple     doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.   "
237734|NCT00961038|"     Objectives of the study are to investigate the safety, tolerability and levels of     ciprofloxacin in the lung after single and multiple inhalative administration to patients     with moderate to severe COPD (stage II-III according to GOLD Criteria)   "
237735|NCT00961051|"     The purpose of this study is to evaluate the safety and effectiveness of an investigational     multi-purpose contact lens solution.   "
237736|NCT00961064|"     Background:        -  Myelodysplastic syndromes (MDS) are bone marrow disorders characterized by anemia,          neutropenia, and thrombocytopenia (low red blood cell, white blood cell, and platelet          counts). Patients with MDS are at risk for symptomatic anemia, infection, and bleeding,          as well as a risk of progression to acute leukemia. Standard treatments for MDS have          significant relapse rates. MDS patients with thrombocytopenia who fail standard          therapies require regular, expensive, and inconvenient platelet transfusions, and are at          risk for further serious bleeding complications.        -  Eltrombopag is a drug designed to mimic the protein thrombopoietin, which causes the          body to make more platelets. Eltrombopag has been able to increase platelet counts in          healthy volunteers and in patients with chronic ITP (a disease where patients destroy          their own platelets very rapidly and thus develop thrombocytopenia), but researchers do          not know if the drug can increase platelet counts in patients with MDS.      Objectives:        -  To find out whether eltrombopag can improve platelet counts in patients with MDS.        -  To determine whether eltrombopag is safe for patients with MDS.      Eligibility:      - Patients 18 years of age and older who have consistently low blood platelet counts related     to MDS that has not responded to conventional treatment.      Design:        -  Treatment with eltrombopag tablets once per day for 90 days.        -  Participants will be monitored closely throughout the initial treatment, with weekly          blood tests and separate evaluations at the National Institutes of Health (NIH)          treatment center every 4 weeks. Bone marrow biopsies may be conducted to check for          abnormalities in bone marrow.        -  If patients show signs of improved platelet counts after 90 days, treatment will          continue with additional doses of eltrombopag.        -  Patients who discontinue taking eltrombopag will be evaluated at the NIH treatment          center 4 weeks after ending treatment, and again 6 months after ending treatment to          check for potential side effects.   "
237737|NCT00961077|"     Stomach cancer is the most common malignant disease and the second most common cause of     cancer-related deaths in the Korea. The elderly are primarily affected by the disease with     most gastric cancer-related deaths occuring in patients aged 65 years or older. Systemic     chemotherapy improves the quantity and quality of life in patients with gastric cancer when     compared with best supportive care. However, elderly cancer patients often present with     concomitant co-morbidities and age-associated physiologic problems that make the selection of     optimal treatment difficult. There is also uncertainty about the use of systemic palliative     chemotherapy in elderly patients because of under representation of this age group in     clinical trials. Therefore, this phase II trial was planned to investigate efficacy and     toxicities of combination chemotherapy with attenuated dose of S-1 and oxaliplatin     (attenuated SOX)in patients with elderly AGC   "
237739|NCT00961103|"     Spinal Muscular Atrophy (SMA) is neurodegenerative disease of anterior horn cells of spinal     cord and represents the second more frequent pathology in childhood.      According to the age of onset and the maximum motor function the disorder is classified in 4     types. Patients with SMA II and SMA III often use orthoses to achieve postural and dynamic     functions.      In this retrospective observational study the investigators describe the characteristics of     sitting position, standing and walking correlated to type and time of orthoses used.   "
237740|NCT00961116|"     This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145     mg fenofibrate tablets in healthy volunteers under fasting conditions. A secondary objective     is to characterize the pharmacokinetic profile of fenofibric acid when administered as a     single 105 mg dose to healthy volunteers in a fasted state. Safety and tolerability of this     regimen will also be evaluated.   "
237741|NCT00961129|"     The aims of this study are to:        1. explore supportive care needs in colorectal cancer patients with treatment and          survivors;        2. compare the supportive care needs in different stage of colorectal cancer;        3. identify the significant factors for the supportive care needs;        4. explore the supportive care needs within one year after newly diagnosis.   "
237742|NCT00961142|"     Feasibility and toxicity of haploidentical allogeneic HCT after a reduced intensity     conditioning regimen with CD3/CD19 depleted grafts. This study enrolls patients with acute     leukemia in complete remission with an indication for allogeneic HCT but without a suitable     HLA-identical donor   "
237743|NCT00961155|"     Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment     of airway inflammation, and it provides information on airway lining fluid composition.     Traditionally, such assessment relies on invasive diagnostic tools such as bronchial biopsy     and bronchoalveolar lavage (BAL) to obtain specimens from the airway but it is very     uncomfortable procedure especially for young patients. The aim of this study is to evaluate     the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway     inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma     allergic to house dust mite. Also, we aim to assess correlations between cytokine     concentrations in EBC and clinical characteristic of the patients with exercise-induced     bronchoconstriction as another phenotype of asthma.   "
237744|NCT00961168|"     The primary goal of this study is to measure changes in biological markers of inflammation in     critically-ill patients with acute lung injury (ALI) or acute respiratory distress syndrome     (ARDS) while they are treated with different styles of lung-protective, artificial breathing     assistance.      Secondary goals are to measure the breathing effort of patients using different artificial     breathing patterns from the breathing machine.      The primary hypothesis is that volume-targeted artificial patterns will produce less     inflammation. The secondary hypothesis is that volume-targeted artificial patterns will     increase breathing effort compared to pressure-targeted artificial patterns.   "
237745|NCT00961181|"     The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel     releasing balloon in patients with in-stent restenosis in a coronary artery.   "
237746|NCT00961194|"     Nowadays, available drugs cannot always produce pain relief in patients with neuropathic pain     disease.      It is believed that drugs acting as antagonists of the N-methyl-D-aspartic acid (NMDA)     receptor may have been efficient in the treatment of neuropathic pain disorders.      Ketamine is the only NMDA receptor antagonist commercially available in France. Ketamine is     usually administered intravenously for surgical anesthesia.      The intravenous administration of ketamine will be difficult to manage in the treatment of     chronic neuropathic pain.      Some trials using oral ketamine for the treatment of neuropathic pain were conducted but     results were heterogeneous. This may be explained by the different range of ketamine doses     tested.      The aim of this clinical trial is to identify a safe and an efficient dose of orally     administrated ketamine for the treatment of peripheral neuropathic pain.      The clinical trial will be conducted in Toulouse Hospital, France. This study is a     randomized, double-blind, placebo-controlled trial. The study will be conducted using 4     parallel groups (three doses of ketamine versus placebo).   "
237747|NCT00961207|"     Study Hypothesis:      Reduction in albuminuria has been shown to decrease progression of diabetic      nephropathy. In diabetic nephropathy patients treated with maximal      antihypertensive doses with dual RAAS blockade (total daily dose valsartan 320      mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg), persistent      albuminuria reflects further additional RAAS activation. Microvascular renal      disease due to increased RAAS activation may be more effectively treated with      triple blockade by the addition of a direct renin inhibitor (DRI) Aliskiren.   "
237748|NCT00961220|"     This phase I/II trial studies the side effects and best dose of carmustine when given     together with O6-benzylguanine and to see how well they work in treating patients with stage     IA-IIA cutaneous T-cell lymphoma. Drugs used in chemotherapy, such as carmustine, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. O6-benzylguanine may help carmustine work better by making cancer cells     more sensitive to the drug. Giving O6-benzylguanine with carmustine may kill more cancer     cells.   "
237749|NCT00961233|"     The purpose of this study is to conduct a clinical trial of two formulations of budesonide     (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if     medication contact time and distribution in the esophagus relates to treatment response. The     investigators will also determine if there is systemic absorption of these topical steroids.     The investigators hypothesize that tissue and symptom response will correlate with esophageal     medication contact time and distribution, and that significant systemic absorption will not     be seen.   "
237750|NCT00961246|"     This study compares the feasibility and efficacy of an individually tailored, child-centered,     Internet-based behavioral intervention with that of general Internet-based health information     for improving health behaviors and relative weight in Chinese-American children during a     6-month period. A total of 60 children (age 10-14) and their families will be randomized to     either the intervention group or control group. The intervention is based on the Social     Cognitive Theory and Transtheoretical Model.   "
237805|NCT00962000|"     The purpose of this study is to look at how the dose of dialysis is affected by the rate at     which dialysate flows through the dialyzer. The dose of dialysis (Kt/V) will be determined by     measuring blood levels of urea at the beginning and end of dialysis at two different     dialysate flow rates.   "
237751|NCT00961259|"     This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose     and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total     single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each     dose is administered under fasted conditions. Safety and tolerability of these regimens will     also be evaluated.   "
237752|NCT00961272|"     The purpose of this study is to characterize the pharmacokinetics of raltegravir in     cervicovaginal fluids as compared to blood plasma of HIV-infected pre-menopausal women.   "
237753|NCT00961285|"     Identification of alterations potentially involved in the complex mechanisms of     leukemogenesis and at the identification and validation of novel biological factors which may     serve as predictors of drug-response and drug-resistance or which may be suitable for     targeted therapy.   "
237754|NCT00961298|"     The investigators propose to evaluate the effectiveness of duloxetine in treating subjects     with both Irritable Bowel Syndrome (IBS) and Generalized Anxiety Disorder (GAD). The     investigators hypothesize that duloxetine as a single therapeutic agent will effectively     target pain and other core symptoms of IBS as well as GAD in this patient population with     both conditions.   "
237755|NCT00961311|"     Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend     1.25 mm angioplasty balloon.   "
237756|NCT00961324|"     This trial is conducted in Europe. The aim of this clinical trial is to evaluate the     variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects     with type 1 diabetes.   "
237757|NCT00961337|"     The purpose of this study is to determine whether inactivated influenza vaccines are     effective to protect school children and their households from getting influenza infection     and further prevent student's absenteeism.   "
237758|NCT00961350|"     Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for     developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.   "
237759|NCT00961363|"     The purpose of this study is to examine the safety and efficacy of sitagliptin 100 mg every     day (q.d.) in improving hyperglycemia and endothelial dysfunction in subjects with impaired     glucose tolerance.   "
237760|NCT00961376|"     The objective of this study is to evaluate the safety and immunologic effects of autologous     tumor vaccination administered with human granulocyte-macrophage colony-simulating factor     (hGM-CSF), and subsequent boosting vaccinations in patients made lymphopenic by treatment     with chemotherapy and infused with autologous PBMC (Cohort A) or CD25 depleted PBMC (Cohort     B). Clinical observations and laboratory measurements will be monitored to evaluate safety,     toxicity, immune responses, and anti-tumor effects. Additionally, the effects of treatment on     tumor response will be evaluated.   "
237761|NCT00961389|"     The objective of this study is to determine the incidence of delirium in adults patients who     are admitted at the critical care unit of a Dutch University Hospital with the mapping of     relevant delirium risk factors The primary aim is to validate the investigators' developed     delirium prediction model for critical care patients.      A secondary aim is to find differences between delirious patients and non-delirious patients     on different aspects of diagnostics, treatment and care, outcome, length of stay, and     inflammation.      According to Dutch law, the need to obtain informed consent was waived by the Committee on     Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).   "
237762|NCT00961402|"     The purpose of this study is to examine the feasibility and efficacy of an exercise     intervention for the prevention of postpartum depression. If efficacious, our intervention     could be disseminated in real world settings in an effort to prevent postpartum depression.   "
237763|NCT00961415|"     This open-label study will assess the efficacy and safety of Avastin with or without     pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent     non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with     Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of     each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive     further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed     (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease     progression. Target sample size is <500 individuals.   "
237764|NCT00961428|"     The purpose of this research study is to determine the importance and level of physical     activity in people with Anorexia Nervosa.   "
237765|NCT00961441|"     To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both     children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.   "
237766|NCT00961454|"     A pilot study to evaluate the ability of photobiomodulation to alter cerebral blood flow in     the frontal poles and to affect the emotional status of patients with major depression.   "
237767|NCT00961467|"     After the discovery of melphalan and prednisone (MP), many clinical trials evaluated the     efficacy of combination chemotherapy, such as VMCP, VBAP, MOCCA in multiple myeloma (MM)     patients, without significant clinical benefit. After 40 years, the combination of MP with     thalidomide (MPT) or lenalidomide (MPR) or bortezomib (MPV) have finally and consistently     shown additive or synergistic effects.In advanced MM, the combination of melphalan,     prednisone and thalidomide induced 12% very good partial response (VGPR) rate, while the     combination of melphalan and bortezomib showed 15% near complete remission (nCR) rate. In     relapsed patients, the combination of bortezomib with MPT (VMPT) induced 43% VGPR rate.     Preliminary results indicate that VMPT may induce a CR rate of around 50% in newly diagnosed     patients (unpublished results).In preclinical studies thalidomide showed more     anti-angiogenesis activity, while lenalidomide showed more immunomodulatory effects, thus     suggesting a combined clinical approach for these two drugs. The toxicity profile of     lenalidomide is completely different from that of thalidomide and no cumulative toxicities     are expected, again suggesting a combination approach. This study will evaluate the safety     and efficacy of combining Lenalidomide, Melphalan, Prednisone and Thalidomide (R-MPT) as     salvage treatment for relapsed/refractory myeloma patients. This association might further     increase the response rate achieved by the standard oral MPT or MPR regimens.   "
237806|NCT00962013|"     The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.   "
237768|NCT00961480|"     A three part study to demonstrate the bioequivalence of a single dose of the Final Market     Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination     (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as     individual tablets. Subject will only participate in one part, receiving treatment A and B     (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).   "
237769|NCT00961493|"     The purpose of this study is to determine whether acceptance-based behavior therapy for GAD     results in greater symptom reduction and increased quality of life than applied relaxation.   "
237770|NCT00961506|"     Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and     recovery compare to laparoscopic cholecystectomy.   "
237771|NCT00961532|"     The investigators intend to show that DDAVP improves platelet activity from baseline to 60     minutes after treatment start.   "
237772|NCT00961558|"     A varicocele is the presence of dilated testicular veins in the scrotum. Although it is     generally agreed that a varicocele is the most common identifiable pathology in infertile men     (detected in up to 40% of men in some series of men with infertility), the influence of a     varicocele on male fertility potential and role of varicocelectomy in restoring of fertility     remain the subject of ongoing controversy. The present controversy on the effect of     varicocelectomy on male fertility potential has led many clinicians to dismiss the diagnosis     of a varicocele altogether and instead, offer alternative treatments to the couple. Many of     these alternative therapies are expensive and risky for the patients and their children.     Several recent reviews have critically examined the results of randomized, controlled trials     of varicocelectomy on fertility potential. The effect of varicocelectomy on spontaneous     pregnancy rates remains controversial.      The investigators hypothesize that a varicocelectomy will result in a significant improvement     in fertility and testicular function in infertile men with a clinical varicocele.   "
237773|NCT00961571|"     This study is for patients with metastatic colorectal cancer who have not been treated with     chemotherapy for their cancer. The purpose of this study is to find out if Capecitabine and     Sunitinib can be used together to improve progression-free survival in colorectal cancer.      All patients will take two medicines (Sunitinib and Capecitabine) by mouth every day until     their cancer gets worse.   "
237774|NCT00961597|"     The purpose of this investigation is to determine the clinical outcome of repair of meniscus     tears located in the red/white region using a well-known suture technique combined, when     indicated, with platelet-rich plasma to enhance healing. The outcome of this operation will     be determined in a consecutive group of patients with an established, rigorous knee rating     system a minimum of 2 years postoperatively. Results will be determined by the analysis of     subjective and functional factors, sports and occupational activity levels, a comprehensive     physical examination, and a radiographic evaluation using standard plain x-rays and magnetic     resonance imaging. The investigators hypothesize that meniscus repairs will significantly     reduce tibiofemoral compartment pain and allow for increased knee function and activity     levels. The platelet rich plasma adjunct will be used in complex meniscus tears in which a     portion of the tear extends into the avascular region classified as either longitudinal,     horizontal, or radial. The investigators hypothesize that the healing rate of these repairs     will be superior to those previously reported in clinical studies in patients who had the     suture repair technique alone.   "
237775|NCT00961610|"     This 2-arm randomized trial assessed the incremental effect of providing a lecture on     Internet use followed by participation in an Internet-based peer support group following a     week-long rehabilitation program, over and above any possible general effect of participation     in the rehabilitation program.      Primary outcome measures are adjustment to cancer and mood disturbance.   "
237776|NCT00961623|"     The diagnosis and monitoring of clinically-significant pathologies of the knee remains     challenging, and it is unknown why only some injuries become painful or respond to surgical     intervention. The limitations of diagnostic magnetic resonance imaging result in arthroscopy     that is not always beneficial. Elucidation of biochemical pathways underlying pain in this     condition may aid patient selection for surgery and provide pharmacotherapeutic targets.     Cytokines or a novel yet uncharacterized protein may be involved in pain following meniscus     injury and diagnostic cytokine assay may help physicians differentiate patients that may     benefit from arthroscopy from those that may not. Additionally, evaluating post-operative     biochemical profiles may provide a method of monitoring surgical outcome and understanding     post-operative continuation or remission of pain.   "
237777|NCT00961636|"     This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms     beyond 6 months and will measure the impact of withdrawal of laropiprant in patients     following 20 weeks of stable maintenance therapy.   "
237778|NCT00961649|"     The purpose of this study was to compare the safety and intraocular pressure (IOP)-lowering     efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to:        -  its individual components (Brinz and Brim), and        -  the concomitant administration of Brinz and Brim (Brinz+Brim).   "
237779|NCT00961662|"     This study is a six-month, prospective, randomized, multicenter, single- blind, controlled     clinical study to evaluate the effect of three low-doses of Naturlose (Tagatose) on glycemic     control and safety in subjects with Type 2 diabetes under diet control and exercise. The     subjects were randomized in one of the 3 arms receiving 2.5, 5 or 7.5 gm of Tagatose.   "
237780|NCT00961675|"     The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in     the treatment of acute otitis externa. This study will be conducted at one site, the LBJ     Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.   "
237781|NCT00961688|"     Women with Polycystic Ovary Syndrome (PCOS) between the age of 18 and 55 are being recruited     to participate in an online survey to determine the impact of PCOS on quality of life and     interaction with the healthcare system. This online survey will take 15-20 minutes to     complete. Participants will receive no direct benefit, but the information provided will     contribute to the knowledge of this condition and the development of improved healthcare for     women with PCOS. For more information or to participate in this study, please visit     http://pcossurvey.vze.com   "
237807|NCT00962026|"     This study is being done to see if an investigational drug called rilonacept is safe to use     in patients with type 1 diabetes, and if it can slow the loss of the body's ability to     secrete insulin in patients who are still able to make a small amount of insulin.   "
237782|NCT00961701|"     Severe Primary hyperparathyroidism (PHP) has been associated with increased cardiovascular     morbidity and mortality. Hypertension, dyslipidemia and impaired glucose tolerance were     demonstrated in severe PHP, with improvement after surgery in these variables. Recent     evidence suggests that the 'quality' rather than only the 'quantity' of low-density     lipoprotein (LDL)-cholesterol exerts a direct influence on the cardiovascular risk. Thus, the     proposed study protocol is intended to evaluate lipoprotein phenotype and LDL size and     subclasses in patients with primary hyperparathyroidism.   "
237783|NCT00961714|"     The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures     by providing internal fixation and stabilization using a titanium implant in conjunction with     OsseoFix+™ polymethylmethacrylate (PMMA) bone cement.      The purpose of the study is to provide reasonable assurance on safety and effectiveness of     the OsseoFix Spinal Fracture Reduction System for market release approval in the US.      This investigational device is intended to restore biomechanical integrity to a vertebral     body that has suffered a painful compression fracture in the thoracic or lumbar spine between     levels T6 and L5.   "
237784|NCT00961727|"     Timely identification, referral and treatment of children who are clinically deteriorating     while admitted to hospital wards is a fundamental element of inpatient care. In community     hospitals, advantages including greater continuity of inpatient-outpatient care, improved     geographic access for families, and lower healthcare system costs, may be undermined if     children with evolving critical illness are not recognized and transferred in a timely     manner. The Bedside Paediatric Early Warning System (Bedside PEWS) is a system of care     designed to augment existing expertise and to provide a safety net for children who are     clinically deteriorating while admitted to hospital wards. The Bedside PEWS is comprised of 4     components; [1] an expert derived, multi-centre validated severity of illness score, [2] an     inter-professionally developed documentation record into which the severity of illness score     is embedded, [3] a series of score-matched care recommendations based on the opinions of over     280 paediatric health care professionals, and [4] an educator-developed     education-implementation program.   "
237785|NCT00961740|"     The study is evaluating the effect of a 14-session cognitive behavioural treatment for     childhood obesity. The treatment is family based and 49 families with children with obesity,     aged 8-12, will be recruited. Outcome measures are: BMI, waist circumference, self-esteem,     social- and psychological functioning, cholesterol, glucose and insulin values, activity     level (actigraphs) and a measure of food intake.   "
237786|NCT00961753|"     The purpose of this study is to determine if increasing the ibuprofen dose will increase the     likelihood of closing the patent ductus arteriosus in premature babies.   "
237787|NCT00961766|"     The primary objective of the study is to determine the safety/tolerability profile, systemic     PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica     participants.   "
237788|NCT00961779|"     The purpose of this study is to obtain evidence of the safety of NNZ-2566 in healthy female     volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female     volunteers.   "
237789|NCT00961792|"     This study attempts to elucidate the factors that contribute to escalation and maintenance of     excessive ethanol drinking in young adults by:        1. Examining subjective and objective response differences to alcohol and other common          substances in a sample of young, adult social drinkers with varying consumption          patterns.        2. Determining whether response to alcohol and other substances is predictive of future          consumption patterns through longitudinal follow-up interviews.        3. Examining the relationship between responses to alcohol and other substances at baseline          and re-examination testing to evaluate if consumption patterns moderate this          relationship.   "
237790|NCT00961805|"     The aim of the present study is to assess the effectiveness of belly dance as a treatment for     pain and improving the quality of life of patients with fibromyalgia.      Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a     dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks     of belly dance twice a week, while the patients in the control group remained on a waiting     list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute     walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck     Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder     Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and     after 32 weeks.   "
237791|NCT00961818|"     The objective of this clinical and experimental study was to verify the immediate effect of     vocal techniques: vibration, nasal sound and articulation in women without vocal complaints.   "
237792|NCT00961831|"     This study is a visual assessment of diagnostic PET/CT images obtained after a single     intravenous injection of BAY85-8050 in patients with cancer   "
237793|NCT00961844|"     In this trial the investigators want to combine chemotherapy with immunotherapy by giving the     patients Temozolomide, before vaccination. The investigators have also included hTERT and     survivin mRNA in the vaccine. Finally, the investigators want to introduce ex vivo T cell     expansion after lymphodepletion for the patients who show an immune response.   "
237794|NCT00961857|"     A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image     (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet     and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg)     as individual tablets. Subject will only participate in one part, receiving treatment A and B     (Part I) or Treatment C and D (Part II).   "
237808|NCT00962039|"     This study aims to determine whether citalopram is a useful, well-tolerated, and safe     treatment for children and adolescents ages 7 to 18 years with functional abdominal pain. The     study hypothesis is that citalopram will be better than placebo in producing clinical     improvement and reductions in abdominal pain. It is also hypothesized that citalopram and     placebo will not differ in terms of safety and tolerability.   "
237823|NCT00962234|"     The causes of failing nutrition status in advanced cancer are not well known. The way fat is     moved, stored, burned or changed into other compounds may be affected and will be followed in     patients using a tracer and other blood tests. The investigators hypothesize that fat loss     and wasting results from low essential fatty acid availability in the body. Changes may occur     in the liver that limits distribution and availability of fat to the body as an energy source     or for other essential functions.   "
237795|NCT00961870|"     This study hypothesize that radius subjecting to mechanical loading may affect excitability     of alpha motor neuron innervating muscle, based on its bone mineral density. If this     hypothesis is valid, it can be firstly suggested that the relationship between bone mineral     density and muscle strength is bidirectional.      A total of 80 voluntaries are planned to include in this study.      After forearm vibration is applied, bone mineral density (BMD) and bone mineral content (BMC)     will be measured in all cases. Alpha motor neuron excitability (H/M ratio, recruitment),     background muscle activity will be evaluated by electromyography at pre-treatment,     post-treatment and, during treatment in cases.      Forearm vibration will be applied by forearm vibration device (FAV). FAV with mechanical     loading will apply forearm. Cases will sit on armchair. Two intervals of FAV will be applied     at a frequency of 45 Hz. Each interval will consist of 60 second of FAV followed by rest.      The right radius BMD and BMC will be evaluated by bone densitometer (GE-LUNAR DPX PRO).      Motor unite potentials at rest, Hoffman reflex, F response, M response will be measured by     electromyography at right flexor carpi radialis. Medtronic Keypoint Portable 2 channel     electromyography and Neurotrac ETS device will be used.   "
237796|NCT00961883|"     Investigators will examine the safety of and immune responses to two vaccines expressing     synthetic HIV proteins: NYVAC-B (a poxvirus), and rAd5 (an adenovirus). The study will     compare responses in participants receiving NYVAC-B first, and rAd5 later, to those who     receive rAd5 first, and NYVAC-B later. A different dose of rAd5 will be tested in each group.   "
237797|NCT00961896|"     Part I was a double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to     evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple     topical administrations of LDE225 (a specific Smoothened inhibitor) on skin basal cell     carcinomas in Gorlin's syndrome patients.      Following a 21-day screening period, patients were exposed to multiple doses of topically     applied LDE225 twice daily for 4 weeks in a double-blind manner. The patients returned weekly     for visits where each BCC was clinically evaluated and digital photographs taken. Local     safety and tolerability was also assessed. After the last application of treatment, biopsies     were taken from treated (both vehicle and LDE225) BCCs (three per patient) for histology,     biomarker evaluation and for pharmacokinetics (skin exposure). In addition, a biopsy from     LDE225-treated uninvolved perilesional skin was taken for pharmacokinetic evaluation. In     total, 4 biopsies were taken: 2 for histology and biomarker and 2 for PK.      Part II of this study consisted of a 21-day screening period, a baseline period (directly     before commencing the treatment period) and a treatment period of 6 or 9 weeks, depending on     randomization. A clinical assessment was performed on site on the last treatment day and if a     full clinical response had been observed, approximately 3 weeks after the last treatment an     excision of the BCC(s) would have been performed. The study completion visit occurred either     1 week after the excision (when this visit was planned) or 1 week after the last treatment.     For a subset of patients, skin biopsies were collected on the last treatment day and an     excision of a BCC was also performed at that same visit.   "
237798|NCT00961909|"     This randomized, double-blind, placebo-controlled study will assess the efficacy, safety,     tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2     diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously     once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current     stable doses of metformin.   "
237799|NCT00961922|"     Introduction:      The aim of this study is to investigate the efficacy of neurofeedback (NFB) to improve     attention, memory and processing speed in children treated for a Brain Tumour (BT). In the     Netherlands every year approximately 100 children are diagnosed with a BT. Nowadays over 65%     of these children have a 5-year survival. Treatment for a BT consists of neurosurgery and /     or local or craniospinal radiation and / or adjuvant chemotherapy. Neurotoxicity caused by     radiotherapy and / or chemotherapy (especially methotrexate) is a major cause of     neurocognitive decline in Childhood Brain Tumour Survivors (CBTS).      Approach:      Studies have shown that NFB has the capacity to improve the brain systems mediating selective     attention and response inhibition in children with Attention Deficit/Hyperactive Disorder     (ADHD). The effectiveness is reported as comparable to methylphenidate (Ritalin) without side     effects of medication. CBTS exhibit symptoms comparable to those of children with ADHD and     positive response to methylphenidate has been found in CBTS. However, NFB has not been used     as an intervention in CBTS yet. The effectiveness of NFB in children treated for a BT will be     investigated in a randomized controlled trial. The intervention group of 30 patients will     receive approximately 30 sessions of NFB; the control group will receive 30 session of     placebo neurofeedback. Neuropsychological tests will be used to evaluate pre- and post-NFB     intervention as well as at a 6-month follow-up.      Relevance:      If NFB proofs to be effective for CBTS this will be a great improvement for their (neuro-)     psychological functioning and quality of life, without the disadvantage of the side effects     of medication. The implementation of this intervention might increase cognitive and social     functioning and thus facilitate integration of these children in society during childhood and     school carrier as well as in adult life.   "
237800|NCT00961935|"     The UCLA Semel Institute for Neuroscience in Los Angeles, CA, is conducting a study looking     at similarities and differences in how the brain works between bipolar disorder and attention     deficit hyperactivity disorder (ADHD).   "
237801|NCT00961948|"     A prospective, randomized trial to determine indigo carmine dye spraying and narrow band     imaging (NBI) of colonic mucosa to detect dysplasia in ulcerative colitis (UC). Confocal     laser microscopy may be beneficial in the further assessment of abnormalities identified by     these methods.   "
237802|NCT00961961|"     The purpose of this study is to determine whether the long-term use of combined     antidepressant plus mood stabilizer therapy is superior to mood stabilizer therapy alone in     preventing the relapse and recurrence of bipolar depression.   "
237803|NCT00961974|"     The purpose of this study was to determine the ability of a family-focused, office-based     intervention to improve medical and behavioral outcomes for children and adolescents with     type 1 diabetes.   "
237804|NCT00961987|"     The aim of this pilot project is to determine if there are differences in patient outcomes     and healthcare utilization between patients randomly assigned to usual care (a collaborative     model of maternity care with co-located healthcare professionals but with referrals to     off-site obstetricians) or to a collaborative model of maternity care with co-located     healthcare professionals, including obstetricians. It is hypothesized that by creating a     seamless interface between obstetrical consultation and ongoing longitudinal maternity care,     patient outcomes (birth outcome data), patient satisfaction and healthcare utilization,     including number of outpatient visits, ultrasounds, laboratory tests, consultations, etc,     will be improved in the intervention group compared with the group receiving usual care. The     results could potentially lead to other sites adopting this innovative model of maternity     healthcare delivery.   "
237824|NCT00962247|"     The primary aim is to examine how reduction in sedentary behaviors influences physical     activity and energy intake.   "
237809|NCT00962052|"     The investigators' long-term objective is to research and develop innovative new tests which     diagnostic laboratories can use to 1) detect methylated DNA targets, 2) tumor specific     antigens, and 3) markers of Bacillus Calmette-Guerin (BCG) treatment in patient urine     samples. The investigators plan to detect methylated DNA targets and control targets by     methylation-specific polymerase chain reaction (msPCR) on DNA isolated from urine samples     from bladder cancer positive and negative patients to determine its sensitivity and     specificity in detecting bladder cancer. The investigators plan to use patient sera as a tool     to detect tumor specific antigens expressed by bladder cancer cell lines. Once a bladder     tumor specific protein is identified, the investigators will assess its presence in the urine     of bladder cancer patients and absence in healthy patients by enzyme-linked immunosorbent     assay (ELISA). The investigators plan to use both in vitro models and patient clinical     samples to elucidate the role of bladder epithelial cells in mediating BCG immunotherapy and     identify biomarkers of treatment effectiveness. Once a biomarker is identified, the     investigators will assess its presence in the urine of bladder cancer and absence in healthy     patients.      Once the investigators determine the feasibility of these tests, the investigators will     further perform an extensive clinical study, comparing the tests to existing diagnostic     methods. This study will provide the foundation for FDA approval, which is required for tests     to become widely accepted tools for clinicians to use in bladder cancer diagnosis. The     investigators' tests will improve early detection of bladder cancer, thereby improving     patient health and decrease cancer deaths, a key mission of the National Institutes of     Health.   "
237810|NCT00962065|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211     versus a placebo control in subjects with type 2 diabetes mellitus.   "
237811|NCT00962078|"     The purpose of this study is to study the effects of a complex pulmonary rehabilitation     program on mobility measured by 6 minute walking distance (6MWD) and physical activity,     measured via Dynaport and Actibelt Aktivitätsmonitor, dyspnoea (VAS), quality of life (HRQL     (SF36, EuroQul)), anxiety and depression (HADS)and PaCO2-behavior under physical activity.   "
237812|NCT00962091|"     This is an open-label, multicenter, phase 1 study to evaluate the safety and pharmacokinetic     properties of an oral solution and enteric-coated tablet (ECT) formulations of MLN8237 in     patients with advanced solid tumors. This study will be conducted in 3 parts, A, B, and C.   "
237813|NCT00962104|"     The purpose of this study is to assess the efficacy, the quality of life, and the safety of     multiple dosing atomoxetine in Asian adult subjects with attention deficit/hyperactivity     disorder (ADHD).   "
237814|NCT00962117|"     The purpose of the study is to determine whether the presentation of various foods produces     an increase or decrease in responses on a motivational computer task. In addition, the study     determines if energy intake or motivation to obtain food is related to the dopamine receptor     genotype.   "
237815|NCT00962130|"     The purpose of this study is to determine if 1) a continuous glucose monitoring system can     measure glucose levels in transferred tissue during reconstructive surgery, and 2) if glucose     measurements from a continuous glucose monitoring system correlate with tissue blood     perfusion.   "
237816|NCT00962143|"     The purpose of this study is to assess the clinical performance of the OrthADAPT Bioimplant     in patients with acute mid-substance Achilles tendon tears requiring surgical repair.   "
237817|NCT00962156|"     -  By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation          in critically ill.        -  High molecular weight HES may, however, cause acute kidney failure in patients with          severe sepsis.        -  Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian          intensive care units (ICU) and 1st choice fluid for patients with severe sepsis.        -  HES 130/0.4 is largely unstudied in ICU patients.        -  This investigator-initiated Scandinavian multicentre trial will be conducted to assess          the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with          severe sepsis.        -  The trial will provide important data to all clinicians who resuscitate septic patients.   "
237818|NCT00962169|"     The purpose of this study is 1) to develop an intervention strategy to increase     physiotherapists' adherence to evidence-based practice guidelines, 2) to try out this     intervention on a small scale to determine what efficacy may be expected from it, and 3) to     determine the value of a planned, systematic and theory-based approach that was followed in     developing and implementing the intervention.   "
237819|NCT00962182|"     The purpose of this study is to examine whether a cocktail of two common food-grade enzyme     supplements leads to decrease of serum activity markers in celiac disease patients     insufficiently treated by previous gluten exclusion.   "
237820|NCT00962195|"     Purple Sweet Potato juice (PSP-juice) is a juice based on purple-fleshed sweet potato     concentrate, containing a high level of anthocyanins. Purple-fleshed sweet potatoes have     attracted attention to industry and scientists due to multiple physiological functions such     as radical-scavenging, ACE-inhibitory and α-glucosidase inhibitory activities in vitro, and     also hepato-protective, antihypertensive and antihyperglycemic effects in vivo. Previous     studies in Japanese subjects showed potential beneficial effects of PSP beverages on liver     function and blood pressure in volunteers with impaired hepatic function and/or hypertension.      The main objective of this study is to examine the effect of PSP-juice on liver enzymes and     blood pressure. The secondary objective is to examine the effects of PSP-juice juice on     insulin resistance.   "
237821|NCT00962208|"     The primary aim of this study is to evaluate and compare the eyeball elongation in children     wearing orthokeratology lenses and single-vision spectacles.   "
237822|NCT00962221|"     Overt hypothyroidism is associated with increased risk for cardiovascular disease (CVD) as     indicated by hypertension, hypercholesterolemia, and increased low-density lipoprotein     cholesterol (LDL-C) levels. Mild hypothyroidism, also called subclinical hypothyroidism [SH]     is highly prevalent in elderly subjects, especially in women older than 50 years of age.     Whether SH is related as a risk for premature CVD is controversial. It was shown that SH is     associated with elevated lipids levels, particularly LDL-cholesterol. However recent evidence     suggests that the 'quality' rather than only the 'quantity' of LDL-cholesterol exerts a     direct influence on the cardiovascular risk. LDL-cholesterol comprises multiple distinct     subclasses that differ in their atherogenic potential. Thus, the proposed study protocol is     intended to evaluate the different LDL lipoproteins subclasses in patients with subclinical     hypothyroidism.   "
237825|NCT00962260|"     This is an open-label expanded access trial of prGCD in patients with Gaucher disease who     require enzyme replacement therapy (ERT) and who have been treated with imiglucerase but for     whom the dose has been reduced or discontinued due to shortage of the product.   "
237826|NCT00962273|"     The purpose of this study is to determine the effects of an interactive, computerized     learning resource designed to increase resilience in hospital-based health care workers     preparing for an influenza pandemic. The effects of the learning resource will be compared to     a non-interactive learning resource condition and a control condition. It is hypothesized     that (a) online pandemic-related education reduces absenteeism and interpersonal problems for     healthcare workers (HCWs), and improves their pandemic self-efficacy in the short and     long-term, and (b) an interactive format for online education is necessary for its benefits.   "
237827|NCT00962286|"     Background: Obesity is associated with a high prevalence of chronic kidney disease. The     glomerular hyperfiltration associated with obesity may play a role in the pathogenesis of     obesity associated chronic kidney disease. Attenuation of hyperfiltration by pharmacological     means may slow down the development and progression of chronic renal failure. The     investigators have previously shown that acetazolamide, a proximally acting diuretic that     activates TGF by increasing solute delivery to the macula densa, abates glomerular     hyperfiltration. The present study was designed to test the hypothesis that this decrease in     hyperfiltration is specific to acetazolamide and not due to a non specific diuretic effect.     The aim of the present study is to evaluate the effects of the administration of furosemide     p.o. to subjects with severe obesity on glomerular hemodynamics.      Methods: Ten obese subjects will participate in the study. They will undergo measurement of     glomerular filtration rate (inulin clearance) (GFR), renal plasma flow (RPF) (p-aminohippuric     acid clearance), filtration fraction, fractional excretion of lithium (FE LI) and blood     pressure, before and after administration of oral furosemide 20 to 40 mg bid for 3 days. The     effects of furosemide on glomerular hemodynamics in obese subjects will be compared to the     previously studied effects of acetazolamide.   "
237828|NCT00962299|"     The aim of the study is to investigate whether inhaled corticosteroids after a first hospital     admission for acute dyspnea and wheeze is effective in reducing subsequent episodes of these     complaints in children aged 1 to 4 years.   "
237829|NCT00962312|"     RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving lapatinib ditosylate together with capecitabine may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with     capecitabine works in treating patients with metastatic pancreatic cancer.   "
237830|NCT00962325|"     For the growing number of severely obese individuals, there are currently few effective     long-term weight control options with the exception of bariatric surgery. However, behavioral     factors including low physical activity can undermine successful surgical outcomes. This     study will compare the effects of a behavioral physical activity intervention with a standard     care control condition on changes in physical activity among inactive adult bariatric surgery     patients.   "
237831|NCT00962338|"     The investigators want to identify limiting factors for short convalescence after     laparoscopic groin hernia repair. Before the operation patients are given intensive     structured information about one day´s convalescence. Patients fill out questionnaire before     operation about several clinically relevant parameters. This is also done first 3 days after     operation and after 1 month and 6 months. The patients are seen for clinical control at 1 and     6 months.   "
237832|NCT00962351|"     This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and     titanium ion levels of a metal-on-metal articular bearing coupled with two different head     sizes to that of a conventional metal-on-polyethylene bearing.   "
237833|NCT00962364|"     This study will provide follow-up information and care of patients who have undergone     autologous intracoronary bone marrow cell administration at our institution. Patients are     monitored for their response to treatment, progression of heart failure and coronary artery     disease, and potential later occurring effects of the administered bone marrow cells.      Patients are eligible for this follow-up study if they have received their first     intracoronary bone marrow cell administration for the treatment of cardiac disease at our     institution from 2001 ongoing.      Participants are generally seen in the clinic at 12 months and 5 years after cell     administration, in the meantime regular yearly telephone contacts are performed until 10     years after cell transplantation.      The detailed description contains the planned procedures that are performed during the     clinical visits and, if necessary, at additional contacts.   "
237834|NCT00962377|"     This study is designed to evaluate the safety and efficacy of a peripheral blood mononuclear     cell gene expression profiling method (AlloMap) in monitoring asymptomatic heart transplant     patients for acute rejection beginning 2-6 months(≥ 55-185 days) after transplantation.   "
237835|NCT00962390|"     The purpose of this study is to assess the safety and effectiveness of S-equol in men with     benign prostatic hyperplasia.   "
237836|NCT00962403|"     The main objective of this preliminary randomized controlled clinical trial is to establish     efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared     to a delayed yoga treatment (waitlist control) group. Secondary objectives are to evaluate     PTSD characteristics that may also be improved with the treatment and acceptability and     compliance with the treatment.   "
237861|NCT00968357|"     SCV-07 (γ-D-glutamyl-L-tryptophan) is a new immunomodulatory compound that has been developed     and patented both for composition and immunomodulatory use and is a synthetic dipeptide. The     efficacy of SCV 07 in treating chronic hepatitis C virus (HCV) infection is expected to arise     from the drug's ability to stimulate the T-helper 1 (Th1) type immune response and to block     signal transducers and activator of transcription 3 (STAT3) mediated signaling. The purpose     of this study is to determine if SCV-07 alone and/or SCV-07 in combination with ribavirin is     safe and potentially effective for the treatment of genotype 1 compensated chronic hepatitis     C in subjects who have relapsed after a response to a previous treatment course of at least     44 weeks with pegylated interferon and ribavirin. All subjects will receive 4 weeks of SCV-07     (Lead-in Phase), followed by 4 weeks of treatment with SCV-07 in combination with ribavirin     (Combination Treatment).   "
237837|NCT00962416|"     Stent study:      Treatment of patients with acute myocardial infarction with drug eluting stents (DES) is     effective but there remain concerns regarding the long-term safety and adverse effects on the     adjacent arterial wall. The biolimus-eluting Biomatrix stent addresses the issues by     incorporating modifications as a biodegradable polymer and a drug application solely to the     abluminal stent surface. While clinical data about the biolimus-eluting stent show a     favorable safety and efficacy profile, they require confirmation in a dedicated randomised     trial in the subset of patients with STEMI. Therefore, the study is designed to compare the     safety and efficacy of biolimus-eluting Biomatrix stent as compared to a bare metal stent of     otherwise identical design in a prospective, multicenter, randomized, controlled superiority     trial in patients with acute ST-elevation myocardial infarction.      Stent and Plaque Imaging Substudy:      In a substudy of the above mentioned stent trial, the investigators will perform a     prospective, multicenter, longitudinal cohort study of 100 consecutive STEMI patients     undergoing urgent coronary angiography and will employ high-resolution Optical Coherence     Tomography (OCT) imaging technology and intra-vascular ultrasound and virtual histology     (IVUS-VH) of the culprit STEMI lesions pre- and postprocedural as well as at a 13 months     follow up. Assessment of vascular wall responses, including volumetric measurements of     vessel, stent, lumen, peri-stent plaque, and intimal hyperplasia, indices of remodeling,     stent expansion, and stent-vessel wall apposition in response to biolimus-eluting and     bare-metal stent implantation will be performed. Moreover, IVUS, IVUS-VH and OCT will be     performed in all three epicardial vessels in order to quantify and map the number, frequency     and distribution of ruptured plaques at baseline and follow-up and quantify the morphological     changes of ruptured and vulnerable plaques at baseline and follow-up and quantify the     morphological changes over time in response to standard medical treatment. Therefore, new     insight regarding the frequency, distribution, composition and evolution of coronary artery     plaques and their prognostic impact on patients clinical outcome can be expected from the     present study. Since patients suffer from a recurrent ischemic event rate of 5-10% during the     first year, these findings may have important therapeutic implications for the medical     treatment of affected patients to further reduce the risk of recurrence and improve     prognosis.   "
237838|NCT00962429|"     The purpose of the study is to examine if alpha lipoic acid is an effective treatment for     chronic inflammatory demyelinating polyneuropathy (CIDP).   "
237839|NCT00962442|"     Acute alcoholic hepatitis (AAH) is the most severe form of alcoholic liver disease (ALD) and     is associated with a high risk of dying in the short term. Corticosteroids are generally     recommended in patients with severe AAH, but its use is still controverted and     contraindicated in case of active infection or gastrointestinal bleeding. Therefore,     alternative therapeutic options are needed.Ethanol consumption results in the depletion of     endogenous antioxidant capabilities and patients with ALD have evidence of antioxidant     deficiencies.Due to its effects on glutathion stores restoration and as such the limitation     of the oxidative stress and its good tolerance and safety profile, N-acetylcysteine (NAC) is     an attractive agent for the treatment of AAH.In this context, we hypothesized that NAC might     be beneficial in severe AAH.   "
237840|NCT00962455|"     Spirometry is a biomedical test to measure lung function in subject who (may) have a chronic     respiratory condition. Performing the test requires a certain level of training and     experience from the health care professional who conducts the test, and sufficient     cooperation of the patient. Although the test is widely used in primary care in many     countries, the quality of the test performance seems limited and needs improvement in order     to avoid false-positive and false-negative test interpretations. In this study, the     researchers investigated whether a combination of e-learning and bimonthly written     performance feedback to family practice nurses and assistance regarding their spirometry     tests improves the rate of adequate tests.   "
237841|NCT00962468|"     Care pathways, a complex intervention to (re)organise, standardize and evaluate care     processes, are used worldwide and in different kinds of settings. Although their     international use, the impact is unclear. The European Quality of Care Pathways Study is the     first international cluster Randomized Controlled Trial on the effect of care pathways for     COPD patients.      The hypothesis is that teams who work with care pathways for COPD patients deliver care that     is more compliant to evidence based key interventions, have better patient outcomes and     higher scores on team indicators than teams who do not work with care pathways.   "
237842|NCT00962481|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of repeated     inhalative doses of Bimosiamose on ozone induced sputum neutrophilia in healthy subjects.   "
237843|NCT00962494|"     Cancer: Surviving and Thriving is a 6-week workshop for cancer survivors. The overall goal of     the study is to determine whether an online cancer survivor education and support workshop     can have lasting beneficial effects in helping survivors improve their self-management of     health skills and quality of life.   "
237844|NCT00962507|"     RATIONALE: Panobinostat and everolimus may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving     panobinostat together with everolimus may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when     given together with everolimus in treating patients with relapsed or refractory lymphoma or     multiple myeloma.   "
237845|NCT00962520|"     This study is a phase II trial of erlotinib in combination with chemoradiation in patients     with resected stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant     chemoradiation. Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus     Capecitabine 800 mg/m2 by mouth twice daily (PO BID) (5 days on/2 days off regimen) and     External Beam Radiation Therapy (EBRT) at doses of 50.4 Gy in 28 fractions after     pancreatectomy (dosing for capecitabine and erlotinib was amended after considering the     toxicity profile of the first 6 patients). Approximately 4-8 weeks after the conclusion of     chemoradiation, it is recommended patients will continue treatment with 4 cycles of     gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.   "
237846|NCT00962533|"     The purpose of this trial is to prove that the strategy of treatment adjustment at W24     according to virological response based on ROADMAP concept is better than standard of care     strategy.   "
237847|NCT00962546|"     Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage after cerebral     aneurysm rupture leading to cerebral ischemia and potentially cerebral infarction. The     current gold standard diagnostic imaging study for cerebral vasospasm is catheter cerebral     angiography, an invasive diagnostic procedure carrying a complication rate of 1-2% per     procedure. Computed tomographic perfusion imaging (CTP) and computed tomographic angiography     (CTA) are noninvasive diagnostic imaging studies frequently utilized in the evaluation of     embolic and thrombotic cerebral infarct. The investigators hypothesize that CTP and CTA may     be utilized as screening tools for cerebral vasospasm following aneurysmal subarachnoid     hemorrhage requiring treatment and provide prognostic information.   "
237910|NCT00971490|"     The objectives of this study are to investigate the effectiveness of Acu-TENS (transcutaneous     electrical nerve stimulation applied on acupoints) on lung functions and quality of life and     to explore the associated underlying mechanisms in subjects with COPD.   "
237848|NCT00962559|"     Introduction:      Almost 50% of patients die after aneurismal subarachnoid hemorrhage (aSAH). 30% of the     survivors suffer from neurological handicap and need permanent care (Suarez et al.). Even     when neurological outcome is good, neuropsychological deficits are frequently observed (Ogden     et al., Anderson et al.) The incidence rate of aSAH is almost 8 of 100.000 per year. Due to     similar clinical symptoms to patients with hypopituitarism, several studies have analyzed the     incidence of hypopituitarism after aSAH. Dysfunction of the anterior pituitary gland was     found in up to 47% (Schneider et al.). GH deficiency was demonstrated in almost every fourth     patient and an association with poor recovery was postulated. In Germany, the investigators     would therefore expect as many as 1200 patients with incident GH deficiency. The KIMS-study     is an observational GH-treatment study in adult onset growth hormone deficiency. Within the     epidemiological data of KIMS, aSAH is not known as a relevant contributing cause (Brabant et     al.). This resembles much of the investigators clinical experience that there is no huge     prevalence of hypopituitarism after aSAH.      Objective: Evaluation of the frequency of hypopituitarism and neuropsychological dysfunction     of any degree in patients with aSAH in a prospective approach.      Methods:      The investigators conduct a prospective study for the evaluation of endocrine deficiency with     aSAH. The investigators study patients 3, 6 and 12 month after aneurismal bleeding. Patients     diagnosed with aSAH with a clinical grade of I-IV according to Hunt and Hess are included in     the study. The investigators perform basal testing for the pituitary by measuring: TSH, LH,     FSH, IGF-1, GH, prolactin and ACTH. For evaluation of the adrenal function the investigators     perform an ACTH-stimulation test (Lindholm et al.). Subjects with evidence for adrenal or GH     insufficiency are further analyzed by insulin-induced hypoglycemia testing (GH Research     Society). In the neuropsychological examination, the investigators screen for verbal     comprehension (Token Test, short form) and visual neglect (line bisection). Verbal and visual     short term memory (digit and spatial span), visuospatial construction and figural memory (Rey     Osterrieth Complex Figure Test), psychomotor speed, attention and concentration (Trail Making     Test Part A and B, d2) as well as mental flexibility (word fluency) are assessed. Patients     additionally fill out a questionnaire measuring actual depressive symptoms and anxiety     (Hospital Anxiety and Depression Scale).   "
237849|NCT00962572|"     A study to see if coordinated aggressive patient management will improve patient treatment     outcomes and is cost effective.   "
237850|NCT00962585|"     The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal     patients with hot flushes and night sweats.   "
237851|NCT00962598|"     The purpose of this study is to examine the effects of a 10-week Omega-3 Fatty Acid treatment     phase on brain chemistry of adolescents with major depressive disorder (MDD) using proton     magnetic resonance imaging.   "
237852|NCT00962611|"     The purpose of this study is to determine the tolerability, maximum tolerated dose and     pharmacokinetics of this drug.   "
237853|NCT00962624|"     The study involves the measurement of immune response to vaccination with three doses of a     meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in     healthy adults (Laboratory workers). The study will be completed at the Manchester Medical     Microbiology Partnership in the UK and will enrol staff who may be at potential occupational     exposure to meningococci. Blood samples will be taken before and after each vaccination and     used to determine if the vaccines induce protective responses.   "
237854|NCT00962637|"     Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene     (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum     testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1     of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit.     Subjects took their medications orally or by rubbing it onto the skin (depending on the     treatment assignment) once daily for up to 6 months. Treatment visits occurred at     approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months     4, 5, and 6.   "
237855|NCT00962650|"     The study will document being able to successfully perform transgastric diagnostic     peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.   "
237856|NCT00962663|"     The purpose of this study is; to determine the pharmacodynamic (PD) effects of ICA-105665     using the intradermal (ID) capsaicin model in healthy male subjects, and to investigate the     effect of ICA-105665 on inflammatory hyperalgesia using the ultraviolet B (UV-B) model in     healthy male subjects.   "
237857|NCT00962676|"     For diagnosis of active tuberculosis, interferon-γ release assay based mycobacterium     tuberculosis specific antigen may show higher sensitivity than tuberculin skin test in     immunocompromised patients. Therefore, interferon-γ release assay have a role as a rapid     diagnostic adjunctive methods for active tuberculosis in immunocompromised patients.   "
237858|NCT00962689|"     Chronic rhinosinusitis (CRS) is the most common chronic medical condition that affects     Americans between 18-44 years of age. While significant advances have been made in the     understanding of the molecular pathogenesis underlying many subtypes of CRS, this has not     translated into widespread changes in how physicians manage adult or pediatric CRS. The focus     of this study is intended to develop testing methods to improve the objectivity and     specificity of diagnosis and allow for individualized therapy with less invasive, customized     treatments instead of the traditional, empiric based, and radically exenterative therapies     commonly employed in clinical practice. Specifically, it is now known that many patients with     CRS have a greater concentration of non-typeable Haemophilus influenzae (NTHI) in the     bacterial biofilms located within their sinus cavities compared to healthy patients. The     specific hypothesis behind the proposed research is that the presence of NTHI biofilms, which     are known to be highly recalcitrant, are positively correlated with the development of CRS     and that unique lipooligosaccharides and inflammatory byproducts obtained from nasopharyngeal     lavage fluids and/or swabs of sinus secretions may be used as a non-invasive biomarker for     CRS. As a result, patients with symptoms of CRS specifically associated with NTHI biofilms     could possibly obtain a non-invasive test in the physician's office that would allow the     clinician to make a more accurate diagnosis and objectively follow each patient's     responsiveness to customized therapy.   "
237859|NCT00962702|"     The dual primary safety and effectiveness outcomes for the use of The TigerPaw System include     the rate of device related adverse and serious adverse events and the extent of complete     exclusion of the LAA with minimal residual cavity.   "
237860|NCT00962715|"     The goal of this clinical study is to learn if Pegasys (pegylated interferon) or Roferon     (interferon) can make the Trivalent Inactivated Influenza vaccine (TIV) more effective in     increasing the body's immune reaction against the flu virus in patients with Chronic     Lymphocytic Leukemia (CLL).   "
237883|NCT00968656|"     The main purpose of this study is to see if Positron Emission Tomography (PET) imaging with a     radioactive tracer called 18F-ISO-1 can accurately identify how quickly cancer cells are     growing or dividing. A second purpose for this study is to determine, by taking pictures,     what tissues and organs of the body take up 18F-ISO-1 naturally and to determine how that     uptake changes over time.   "
237862|NCT00968370|"     The impetus for this study came from the findings of the investigators' recently published     study entitled Day-care management of severe and very severe pneumonia, without associated     co-morbidities such as severe malnutrition, in an urban health clinic in Dhaka, Bangladesh.     If day-care management is found to have comparable efficacy to that of hospital management of     severe and very severe pneumonia in children then they could be managed at outpatient,     day-care set ups reducing hospitalization and thus freeing beds for management of other     children who need hospital care. Such management could also be implemented in rural areas of     Bangladesh and potentially to other developing countries. Additionally, availability of the     treatment facility in community set-ups will be cost and time saving for the population. But,     as patients with severe malnutrition were excluded from the pilot study for ethical reasons,     the peer reviewers of the manuscript felt that the study findings cannot be applied to the     treatment of severe and very severe pneumonia in general. Similarly, management of severely     malnourished children with associated complications relies on hospital-based treatment. In     another study, a day-care clinic approach by providing antibiotics, micronutrients, diet and     supportive care to severely malnourished children showed that they could be successfully     managed at existing day-care clinics using a protocolized approach. Therefore, after the     successful conduction and publication of these two study results in international journals     with severe and very severe pneumonia as well as severe malnutrition at the day-care clinic,     it is mandatory to perform the final study where the investigators will include severe     malnutrition as well as associated co-morbidities to be applied to the treatment of severe     and severe pneumonia in children in general to make the treatment approach more widely     applicable.   "
237863|NCT00968383|"     The purpose of this study is to determine whether opening an occluded infarcted artery 3-28     days after an acute myocardial infarction in high-risk asymptomatic patients with preserved     infarct zone viability improves left ventricular systolic function and volumes at 6 months     follow-up. The secondary purpose is to assess the changes in myocardial tissue     characteristics after late percutaneous coronary intervention (PCI).   "
237864|NCT00968396|"     The goal of this clinical research study is to learn if cleaning the stem cells of a patient     who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product     capable of replacing the bone marrow after standard treatment with chemotherapy.   "
237865|NCT00968409|"     The purpose of this study is to see if Positron Emission Tomography (PET) imaging with a     radioactive form of the hormone progesterone called FFNP will give the same results as     hormone receptor testing already performed on tissue used to diagnose breast cancer.   "
237866|NCT00968422|"     The objectives of this study are to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of ABT-384 in elderly subjects.   "
237867|NCT00968435|"     The purpose of this study is to determine the effectiveness of treatment with bevacizumab +     cisplatin + cetuximab + IMRT. The doctor wishes to monitor patients for 2 years after the     completion of study treatment to determine if they are cancer-free during that time. They     also want to evaluate the side effects that patients experience with this treatment regimen.   "
237868|NCT00968448|"     The purpose of this study is to determine weather well trained athletes benefit from     inspiratory (respiratory) muscle training.   "
237869|NCT00968461|"     The goal of this clinical research study is to learn the highest tolerable dose of phenethyl     isothiocyanate (PEITC) that can be given to patients who have a lymphoproliferative disorder     that has been treated with fludarabine. The safety of PEITC will also be studied.   "
237870|NCT00968487|"     A single-site, single-blind study of ascending doses of Lyophilized Plasma in normal healthy     volunteers.   "
237871|NCT00968500|"     The purpose of this study is to understand the experiences and needs of parents who have lost     a child to cancer. This will aid us in developing an intervention that may help parents cope     with their loss.   "
237872|NCT00968513|"     This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying     intensities for smokers hospitalized on acute psychiatric inpatient units.   "
237873|NCT00968526|"     The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals'     investigational vaccine GSK2340272A.   "
237874|NCT00968539|"     The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals'     investigational vaccine GSK2340272A.   "
237875|NCT00968552|"     The investigators' believe that it is important to medical practice to obtain information on     how expandable metal stents work in a large group of patients who have metal stents placed in     the gastrointestinal system. The purpose of this research study is to collect information on     the stent placement in our facility and how the patients responded to the stent placement.   "
237876|NCT00968565|"     The purpose of this study is to determine the safety and efficacy of citrate to provide     anticoagulation of an ECMO circuit without patient anticoagulation. The standard method of     providing ECMO circuit anticoagulation is the use of heparin which also anticoagulates the     patient and increases the risk of patient bleeding.   "
237877|NCT00968578|"     The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg     iv) versus placebo on postoperative outcome after knee arthroplasty.      The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and     improve outcome.   "
237878|NCT00968591|"     This clinical pharmacology research study will assess the safety and pharmacokinetics of the     drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.   "
237879|NCT00968604|"     The goal of this clinical research study is to find the highest tolerable dose of BikDD     nanoparticle that can be given to patients with advanced cancer of the pancreas. The safety     of this drug will also be studied.   "
237880|NCT00968617|"     This study will define an effective starting dose for subcutaneous administration of MK2578     to correct anemia in erythropoiesis-stimulating agent (ESA)-naive patients with chronic     kidney disease (CKD) who are not on dialysis while evaluating its safety.   "
237881|NCT00968630|"     This phase II trial studies the immune response after stem cell transplant in human     immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer).     Studying samples of blood from HIV-positive patients with cancer in the laboratory may help     doctors learn more about changes that occur in the immune system after stem cell transplant.   "
237882|NCT00968643|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known     which radiation therapy schedule is more effective in treating patients with malignant spinal     cord compression.      PURPOSE: This randomized phase III trial is studying two different radiation therapy     schedules to compare their side effects and how well they work in treating patients with     malignant spinal cord compression.   "
237884|NCT00968669|"     To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in     adult participants with uncontrolled, moderate-to-severe, persistent asthma.   "
237885|NCT00968682|"     RATIONALE: Studying samples of blood in the laboratory from patients with cancer treated with     trastuzumab may help doctors learn more about biomarkers related to heart dysfunction. It may     also help doctors predict which patients will develop heart dysfunction.      PURPOSE: This clinical trial is studying biomarkers to see how well they predict heart     dysfunction in women with breast cancer treated with trastuzumab.   "
237886|NCT00971165|"     High blood pressure is the major risk factor for Cardiovascular disease (CVD). The prevalence     of hypertension in Brazil was established in population-based studies conducted in different     cities and States, varying from 22.3 to 44% of adults.      The benefit of drug treatment of hypertension to prevent major cardiovascular events was     consistently demonstrated in a large series of clinical trials controlled by placebo.      Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well     tolerated, have longer duration of action and the advantage of very low cost to be used in a     population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is     to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized     by a potassium-sparing diuretic, as amiloride.      A study comparing diuretic with an ARB agent is therefore recommendable in Brazil, in order     to support the decisions of the Health Secretary in regard to blood pressure agents supply     for the Brazilian population. Such a study was demanded and funded by the Health and     Technology Ministries in Brazil.   "
237887|NCT00971178|"     Dexmedetomidine is an alpha 2-adrenoreceptor agonist, which provides sedation, analgesia and     anxiolysis in clinical practice (Cortinez et al., 2004,Hall et al., 2000). Three types of     alpha 2-adrenergic receptor subtypes are found in the human body and they have been     designated alpha 2A, alpha 2B and alpha 2C. The alpha 2A subtype is most likely responsible     for the analgesic properties of dexmedetomidine in both peripheral and central sites (Kingery     et al., 2000, Smith et al., 2001). Activation of central alpha 2-adrenoreceptors in the locus     ceruleus (Correa-Sales et al., 1992) and the dorsal horn of the spinal cord (Gaumann et al.,     1992b) are responsible for both analgesic and sedative effects. Dexmedetomidine has a very     high alpha 2 to alpha 1 selectivity, 1620 to 1, or approximately 8 times that of clonidine.     It is also 4 to 6 times more potent than clonidine by weight (Bhana et al., 2000).      Although dexmedetomidine produces dose dependent sedation upon intravenous administration,     its the analgesic effect is of dexmedetomidine is more variable and controversial. In an     ischaemic pain model in healthy volunteers, a single bolus of dexmedetomidine produced a 50%     reduction in pain scores when compared to placebo (Jaakola et al., 1991). In another     volunteer study using the cold pressor test, dexmedetomidine 1 µg/kg over 10 minutes followed     by an infusion of 0.2 to 0.6 µg/kg/hour reduced pain by approximately 30% (Hall et al.,     2000). However, when administered as a target controlled infusion at concentrations ranging     from 0.09 to 1.23 ng/mL, dexmedetomidine had no analgesic effect in human volunteers     subjected to heat and electrical pain, although sedation was produced (Memis et al., 2004).      Clonidine and dexmedetomidine are two common alpha 2 agonists used clinically. Although     clonidine former has been used successfully in regional analgesia and anesthesia (Gabriel et     al., 2001)., There are only very few studies evaluating the peripheral analgesic effects of     dexmedetomidine. Since acute postoperative dental pain is a common analgesia model (Cooper,     1991; US Food and Drug Administration 1992), the investigators conducted this study, aiming     to assess the postoperative analgesic efficacy of peripheral dexmedetomidine after bilateral     third molar surgery under general anaesthesia. The analgesic effects were compared up to the     72nd hour postoperatively in order to evaluate any potential preventive analgesic effect.   "
237888|NCT00971191|"     This study will enroll patients who are planned to undergo surgical removal of their tumor.     The goal of the study is to evaluate the changes that occur in the tumor after brief (about 8     days) exposure to the study drug.   "
237889|NCT00971204|"     This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation     in the treatment of paroxysmal atrial fibrillation.   "
237890|NCT00971217|"     To date very little research has focused on the mental health of young men. The main aim of     the proposed research is to explore the effectiveness of a combined exercise and     internet-based cognitive behavioral therapy (CBT) intervention (called Back of the Net) on     indices of suicide risk in young men. A second aim is to explore the relationship between     physical self-concept, self esteem, body fat composition, body circumference and changes in     depression as a result of an exercise intervention. It is hypothesised that the combined     exercise and internet-delivered CBT intervention will have greater benefits for indices of     suicide risk compared to an exercise-only intervention, an internet-delivered CBT-only     intervention and a control condition.   "
237891|NCT00971230|"     This study will evaluate the safety and acceptability of an intermittent and daily PrEP     regimen using Tenofovir Disoproxil Fumarate plus Emtricitabine (FTC/TDF) in men and women at     risk for HIV, and it will directly compare adherence and intracellular drug levels in daily     and intermittent PrEP recipients. It will also evaluate the relationship between drug     adherence, sexual behavior and intracellular drug levels with an intermittent PrEP regimen.     In addition it will evaluate the relationship between adherence to an intermittent PrEP     regimen and timing of sexual activity in relation to PrEP dosing. The study will use     objective medication event monitoring medication event monitors (MEMS) adherence measurement     and evaluate the feasibility of newer adherence measurements such as hair sampling and plasma     drug levels. The study will also evaluate the feasibility of using SMS (text messages) to     collect sexual activity data in an African setting. It will allow study teams and communities     to prepare for potential subsequent larger trials of intermittent PrEP. This study is not     sized to evaluate efficacy. If the intermittent PrEP regimen is shown to be safe, feasible in     terms of adherence, and achieves intracellular drug levels similar to daily PrEP, these data     could be used to design a larger phase 2 study with one or more intermittent PrEP regimens.     The goal of such a trial would be to provide bridging data if daily PrEP regimens are found     to be effective or to prepare for efficacy or non-inferiority trials of intermittent versus     daily PrEP.      Investigation of immune responses associated with FTC/TDF will also be evaluated in the pilot     study. The proportion of volunteers on FTC/TDF with HIV-specific immune responses, due to     exposures that did not lead to established HIV infection, will be assessed at 2-3 time points     and compared to responses in volunteers assigned to placebo. Immune responses may be     correlated with risk behavior and host factors, such as human leukocyte antigen (HLA) type.     As noted above, very few HIV infections are expected to occur during the study, so     correlation of HIV-specific immune responses and protection from infection or attenuation of     disease progression will not be possible until a larger study is conducted.   "
237892|NCT00971243|"     The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination     with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate     the safety and efficacy of MP-513 in combination with Metformin with an extension treatment     for up to 52 weeks.   "
237893|NCT00971256|"     Review bladder cancer patients and form a database in regards to urine cytology.   "
237894|NCT00971269|"     The study is an open, prospective, single-site study where 16 patients suffering from fecal     incontinence will be included. Change in fecal incontinence episodes after intersphincteric     injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.   "
237895|NCT00971282|"     This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral     (split-face) comparison.      The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in     reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.   "
237896|NCT00971295|"     The primary objective was to investigate whether multiple-dose administration of     eslicarbazepine acetate affects the pharmacokinetics of metformin.   "
237897|NCT00971308|"     The purpose of this study is to determine the antiviral effect following three days of dosing     with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected     subjects.   "
237898|NCT00971321|"     This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of     GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35     months.      This protocol posting has been updated following protocol amendment 4, March 2010. The     protocol posting sections impacted are number of subjects, primary and secondary endpoints     and intervention.   "
237899|NCT00971334|"     The purpose of this study is to collect samples for the purpose of developing a prenatal     aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from     pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by     chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff     aneuploid test will be compared to the chromosomal analysis obtained via CVS or     amniocentesis.   "
237900|NCT00971347|"     This is a randomized controlled trial of the effects of chewing gum on body weight. The     investigators will randomly assign 200 overweight or mildly obese adults to one of two     groups. Participants must be otherwise healthy and ages 19-50. The control group will receive     only printed information on optimal diet and increasing physical activity. The intervention     group will be instructed to chew gum following meals and in place of snacks for a minimum of     90 minutes per day. The intervention group also will receive the same information on optimal     diet and increasing physical activity as the control group. In this 8-week intervention, the     primary outcome will be change in body weight, and secondary outcomes will be changes in body     mass income (BMI), waist circumference, and blood pressure. The protocol includes 3 clinic     visits to assess outcomes: baseline, 4 weeks after randomization, and 8 weeks after     randomization. Adherence to the gum chewing protocol will be assessed at clinic visits and     during 2 telephone calls at 2 weeks and 6 weeks post-randomization. The investigators'     hypothesis is that gum-chewers will lose more weight than those who receive information only.   "
237901|NCT00971360|"     The aim of this study is whether the proinflammatory cytokine levels in patients with     conversion disorder is increased or not changed in the acute phase and subacute - chronic     periode, compared with controls.   "
237902|NCT00971373|"     This is a pilot study to determine the effectiveness of antimicrobial scrubs on bacterial     burden of HCW's hands and clothing in a clinical setting.   "
237903|NCT00971386|"     Heart failure is associated with faster breathing, which has a negative impact on the     functioning of the heart. This leads to fatigue, shortness of breath, and exercise     intolerance. It has been shown that when slow breathing technique was taught to patients with     heart failure, they had a reduction in their sensation of shortness of breath and an     improvement in their exercise performance.      The study will compare the short-term effects of controlled slow breathing with biofeedback     in normal healthy subjects, acute heart failure, and chronic stable heart failure. The     purpose is to see if there is any change in the objective measurements of heart function     while breathing at normal rates compared to a controlled slower rate.   "
237904|NCT00971399|"     The purpose of this study is:        1. To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced          nausea and vomiting in the treatment of gastrointestinal cancer.        2. To verify an improvement of 20% in complete response rate in term of radiotherapy          induced nausea and vomiting (from 60% with ondansetron to 80% with ramosetron).   "
237905|NCT00971425|"     The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals'     investigational vaccine GSK2340272A.   "
237906|NCT00971438|"     Patients with acute abdominal pain and suspicion of appendicitis are common. The management     of these patients is controversial with large variations between hospitals. The clinical     diagnosis is regarded as insufficient necessitating the use of diagnostic techniques like     ultrasound, computerized tomography and diagnostic laparoscopy. However, the role of these     diagnostic techniques is not clear.      This aim of this prospective interventional study is to analyze the impact of the     implementation of a clinical score to improve the clinical diagnosis and to serve as a basis     for a structured management of these patients by comparison of the results after the     implementation of the score with that of a baseline period. In the group of patients with     indeterminate diagnosis according to the clinical score, the value of diagnostic imaging will     be evaluated and compared with a period of in-hospital observation by randomization. The     hypothesis is that a clinical score will decrease the use of unnecessary diagnostic imaging     and unnecessary admissions to hospital for observation.   "
237907|NCT00971451|"     Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and     scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be     recruited to participate.      All subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior     to their surgery. Each session will include supervised therapeutic exercises. Subjects will     be randomly assigned to receive continuous transcutaneous electrical nerve stimulation (TENS)     during each session or knee joint cryotherapy prior to each exercise session. The     investigators will measure quadriceps function before and after this 2-week intervention     (both sessions occur prior to reconstruction surgery). This study will also have a true     control group that will not receive either exercise of modality intervention. The     investigators will collect subjective and objective outcomes data at regularly scheduled     post-operative visits.   "
237908|NCT00971464|"     Patients with advanced Age-Related Macular Degeneration will be randomized into one of two     treatment groups. One group will receive eccentric view (EV) training while the other a     closed circuit television (CCTV) training for 6 weeks. Reading speed and accuracy will be     assessed pre- and post- treatment to determine if one treatment is superior to the other.   "
237909|NCT00971477|"     The purpose of this study is to determine if an asynchronous online model of teledermatology     can achieve similar clinical outcomes as compared to conventional in-office care for the     management of psoriasis. The investigators also aim to determine the effects of this online     care model on patient quality of life as well as patient and physician satisfaction.      The investigators' hypotheses include the following:        1. Compared to in-person visits, the online care model will result in similar clinical          improvement in psoriasis disease severity.        2. Compared to in-person visits, the online care model will result in similar improvements          in quality of life.        3. Providers and subjects in the online group will achieve a similar level of overall          satisfaction as those in the in-person group.   "
237911|NCT00971503|"     Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute     a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the     body's own immune system attacks and destroys the cells that make insulin. Exogenous     administration of insulin is the primary method of controlling type 1 diabetes by regulating     blood glucose levels, but this treatment does not reverse nor prevent disease progression.      Our hypothesis is that when implanting stimulated total bone marrow by arterial injection     directly into the pancreas, we will achieve functional recovery of insulin-producing cells.     This study will include patients with chronic type 1 diabetes and absence of lesions in     target organs. We will follow the evolution of patients receiving autologous total bone     marrow implantation by selective catheterization and compare to a non-treatment control     group. All subjects will continue to use insulin therapy as needed to maintain the best     possible glucose control.      The objective is to achieve a significant increase in C-peptide levels indicating a     regeneration of the beta islet cells with a decrease in exogenous insulin usage in at least     70% of the patients.      This study is a follow-up to our initial study in which 22 patients received autologous total     bone marrow. The initial study was 100% safe but additional studies like the one described     above are needed to show efficacy.   "
237912|NCT00971516|"     The main goal of this study is to look at the way gums heal around dental implants placed in     healthy patients compared to patients with type 2 diabetes. This study is designed to answer     the following questions:        -  How much swelling occurs around dental implants placed in patients with type 2 diabetes?        -  Is swelling (inflammation) present or absent in the initial healing phase after          placement of dental implants?        -  What are the differences in the amount of swelling (inflammation) in patients with and          without type 2 diabetes? Are patients with type 2 diabetes more likely to have bone loss          around dental implants?   "
237913|NCT00971529|"     Cigarette smoking is the major risk factor for a series of life threatening diseases     including cancer and heart attack, which causes millions of deaths each year worldwide. Many     of the harmful effects of cigarette smoking can be reversed by quitting; however, due to the     addictive nature of nicotine, quitting smoking is extremely difficult. Despite the efforts,     currently available methods produce only modest smoking cessation rates with relapse.     Previously, tea components were shown to protect effect against cigarette smoke-induced     toxicity. Here the investigator reported an unprecedented smoking cessation effect of tea.     Green tea was made into cigarette filters and tested for its smoking cessation effect in a     double-blind clinical study. The tea filter could effectively achieve abstinence relapse     using smoking process to quite smoking and easy to be used by smoker without any side effects     and psychological obstacles. This work provides a new idea and innovative method to combat     tobacco epidemic. Its implementation and popularization may make a great contribution towards     to reducing the smoking-related diseases, and relieving the public health burden and     pollution caused by cigarette smoking.   "
237914|NCT00971542|"     The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate     immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new     swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and     adolescents. A booster dose will be administered 12 months after the first vaccination.   "
237915|NCT00971555|"     Transient hypothyroxinemia (TH) is a condition characterized by low levels of serum thyroxine     (T4) and normal levels of thyroid stimulating hormone (TSH). TH in premature infants has been     found to be related to severity of illness. T4 levels in very low birth weight infants born     prematurely has been found to be inversely correlated to severity of illness. In very low     birth weight infants, TH has been associated with poor outcomes. Little is known about     thyroid function in late preterm infants.      Hypotheses:        1. Ill late preterm infants will have lower total T4 levels than healthy late preterm          infants.        2. Total T4 and possibly TSH levels will be inversely correlated with short-term outcomes.        3. Late Preterm infants born by cesarean section will have lower T4 levels compared to          those born by vaginal birth.   "
237916|NCT00971568|"     This is a retrospective study of urine samples stored in the Beaumont BioBank for future     research. The urine samples will be drawn from the urine back with patients previously     diagnosed with severe interstitial cystitis (IC), mild IC and no IC.      Interstitial Cystitis (IC) also known as Painful Bladder Syndrome (PBS) is a chronic     inflammatory disease. It has an unknown etiology, symptoms which present to varying degrees,     as well as an uncertain natural history. Diagnosis of IC is based on symptoms after excluding     more common and dangerous pathologies.   "
237917|NCT00971581|"     Primary Objective:      To confirm the safety and tolerability of the fixed dose combination of a Non-Steroidal     Anti-Inflammatory Drug (NSAID), ketoprofen, associated to a Proton Pump Inhibitor (PPI),     omeprazole, in Mexican patients.      Secondary Objective:      To confirm the efficacy of the combination:        -  Relief of pain (Visual Analyzed Score (VAS))        -  Patients global assessment of disease activity, scored as a scale of 1 (no limitation of          normal activities) to 5 (inability to carried out all normal activities)   "
237918|NCT00971594|"     The purpose of this study is to investigate the mechanisms by which physical inactivity and     obesity alter skeletal muscle insulin signaling to cause insulin resistance and increase the     development of impaired glucose tolerance (IGT).   "
237919|NCT00971607|"     Ischemic postconditioning can reduce myocardial injury following myocardial infarction.      A potential pharmacological agent is the anesthetic Sevoflurane. The investigators'     hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will     reduce infarct size.   "
237931|NCT00971763|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cyclophosphamide,     vincristine sulfate, and prednisolone, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as rituximab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Giving more than one drug (combination chemotherapy)     together with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying giving gemcitabine hydrochloride, cyclophosphamide,     vincristine sulfate, and prednisolone together with rituximab to see how well it works in     treating patients with newly diagnosed diffuse large B-cell lymphoma.   "
237920|NCT00971620|"     Cutaneous leiomyomas are benign tumors of smooth muscle origin. They can be very painful, and     current treatments for the tumors and for the associated pain do not produce satisfactory     results. One potential treatment for localized severe muscle pain involves injections with     botulinum toxin A. This study will investigate the effectiveness, side effects, and dosage of     botulinum toxin A (BOTOX) as a treatment for patients with pain associated with cutaneous     leiomyomas.      This study will include 18 subjects, all of whom will be 18 years of age and older, who have     pain associated with cutaneous leiomyomas.      For the 24-week study, patients will be randomly assigned to one of two treatment groups.     Neither the study team nor the patient will know to which group patients have been assigned.     Before the study begins, all participants must provide a full medical history for research     and evaluation purposes, fill out pain and quality-of-life questionnaires, and undergo an ice     test in which researchers will apply ice to the site of the cutaneous leiomyomas and ask     participants to evaluate the level of pain before and after ice application. Both groups will     be required to keep a pain diary throughout the study to record their level of pain on a     daily basis, and will be asked to avoid or restrict the use of specific medications or other     remedies to treat the pain.      At the first visit (Week 0), one group will receive a prescribed dose of botulinum toxin A,     which will be administered as an injection into the leiomyoma, and the other (control) group     will receive a placebo injection of a saline solution. Patients will return 4 weeks later, at     which time they will undergo a medical examination, and the ice test, and complete     questionnaires to assess responses and level of pain. Patients will return in Week 12, at     which time the group assignment will be revealed (un-blinded) to investigators and patients.     Patients who received placebo injections will be offered the opportunity to receive injection     of botulinum toxin A into their leiomyomas. All patients will undergo a medical examination,     the ice test, complete questionnaires, and continue completing their daily pain diaries at     home. The final visit, in Week 24, will follow the same procedure as the Week 4 visit.      At the end of the study, patients may be eligible to have one or more of the painful     cutaneous leiomyomas surgically removed if the researchers believe that the skin lesions can     be removed with a reasonable cosmetic result.   "
237921|NCT00971633|"     This study will assess the bioequivalence of a Merck clinical trial formulation of     ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.   "
237922|NCT00971646|"     Over the past few years it has become clear that our understanding of bladder physiology is     inadequate to explain urge incontinence. This has forced us to re-evaluate what we know and     do not know about bladder function and dysfunction. This has led to the identification and     study of novel systems within the bladder that may contribute to abnormal sensations.      The investigators now suspect that the organic changes occurring in the bladder are not the     whole story. For one group of patients with pathological urge there is growing evidence     suggesting that there may be a strong psychological component. The idea now being put forward     is that normal afferent peripheral information is perceived as abnormal and excessive,     resulting in an increased desire to go to the bathroom: 'perceptual urge'. It is important to     identify this group of patients since it will direct their treatment towards more cognitive     approaches. Also, if such a psychological aetiology can be eliminated it would lead to a more     focused and effective management of peripheral pathology with surgery or pharmacology.   "
237923|NCT00971659|"     This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or     a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and     their effect on blood glucose control, versus insulin glargine alone as active comparator in     type 2 diabetes.   "
237924|NCT00971672|"     The frequency of iron deficiency anemia was extensively studied in infants on the first year     of life. There is not enough information about the frequency of iron deficiency during the     second and third years of life. In a previous study performed in Israel and published in     Pediatrics 2006 the incidence of anemia does not decrease towards age 18 months. Then there     is reasonable to study the iron deficiency frequency beyond this age.   "
237925|NCT00971685|"     Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity.     Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and     vascular endothelial growth factor (VEGF). The association with dexamethasone increased     Lenalidomide response rate.      More recently the efficacy of Lenalidomide has been reported in a patient with POEMS     (POEMS:polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)     syndrome with improvement of clinical condition and reduction of vascular endothelial growth     factor (VEGF) and interleukin-6 (IL-6) level.   "
237926|NCT00971698|"     The spleen in Sickle Cell Anemia and Sickle Cell Thalassemia is usually enlarged in the first     years of life but the immune protection provided is considered insufficient. In homozygous     Sickle cell patients the spleen usually developed recurrent infarcts and after the first     decade of age become fibrotic. Acute splenic sequestration is also frequent in those patients     and this is considered as an indication for splenectomy.      In comparison in Sickle cell thalassemia patients, hypersplenism is more frequent.      The purpose of this study is to compare the clinical and laboratory issues related to the     spleen in two groups of Sickle cell patients.   "
237927|NCT00971711|"     Determine the safety and preliminary effectiveness of VSL#3 in adults with IBS.   "
237928|NCT00971724|"     Primary objective:        -  To identify a biomarker or biomarker-set for the adverse metabolic effects of various          doses of prednisolone treatment.      Secondary objectives:        -  To describe the PK of prednisolone and PD of a series of biomarkers.        -  To identify biomarkers that reflect side effects of prednisolone.        -  To elucidate part of the mechanisms by which prednisolone induces metabolic changes.   "
237929|NCT00971737|"     RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective     immune response to kill tumor cells. Biological therapies, such as cyclophosphamide and     trastuzumab, may increase the number of immune cells and make the immune response stronger.     It is not yet known whether giving cyclophosphamide together with vaccine therapy is more     effective with or without trastuzumab in treating patients with metastatic breast cancer.      PURPOSE: This randomized phase II trial is studying the side effects of giving     cyclophosphamide together with vaccine therapy and to see how well it works compared with     giving cyclophosphamide and vaccine therapy together with trastuzumab in treating patients     with metastatic breast cancer.   "
237930|NCT00971750|"     The objective of this study is to prospectively compare laparoscopic ultrasound to     transabdominal ultrasound for the detection of gallbladder pathology in obese patients     presenting for laparoscopic gastric bypass. We hypothesize that laparoscopic ultrasound will     be more sensitive and specific for cholelithiasis than transabdominal ultrasound in morbidly     obese patients.   "
237932|NCT00971776|"     The AB Portable Driver System will allow patients supported with the Circulatory Support     System to be discharged home when their medical condition improves to an ambulating status     and will continue to receive the assistance of the AB 5000 ventricle for their heart     recovery.   "
238087|NCT00959049|"     The purpose of this study is to determine the immunogenicity and safety profile of CSL     Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus     Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18     years.   "
237933|NCT00971789|"     Background:      People with phosphatase and tensin homolog deleted on chromosome 10 (PTEN) hamartomatous     tumor syndromes (PHTS) have a mutation in one of their genes called PTEN that can lead to     benign tumors called hamartomas throughout the body. This puts them at increased risk for     breast, thyroid and endometrial cancer.      People with a PTEN mutation have increased activity of proteins such as protein kinase B     (AKT) and mammalian target of rapamycin (mTOR), which may be responsible for tumor growth and     their increased risk of these cancers.      Experiments show that a drug called sirolimus, which is used to prevent the immune system     from rejecting transplanted organs, can inhibit cancer cell growth by blocking the mTOR     protein.      Objectives:      To test the ability of sirolimus to decrease the activity of proteins that are regulated by     mTOR in both benign and cancerous tumor tissue.      Eligibility:      People 18 years of age and older with Cowden syndrome or other PHTS.      Design:      Sirolimus treatment. Patients take sirolimus once a day in 28-day treatment cycles. Patients     who do not have cancer take the drug for a total of two cycles (56 days) unless they develop     unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until     their disease worsens or they develop unacceptable side effects.      Evaluations. Patients come to the clinic for a history and physical examination on day 1 of     every treatment cycle, then every month for the first two months off therapy, and then at 6     and 12 months. In addition, they have the following procedures:        -  Positron emission tomography (PET) scan and neuropsychological testing before starting          treatment.        -  Clinical photography (photographic documentation of skin lesions) before starting          treatment. Patients who do not have cancer have repeat photography at 2 and 8 weeks and          then, if the lesions shrink or go away while on therapy, again every month for the first          2 months off sirolimus, then at 6 months and 1 year. Patients who have cancer and          continue treatment beyond 8 weeks have repeat photography every 8 weeks while on the          study.        -  Digital dermoscopy (skin lesion examination using a high resolution camera). This is          done at the same intervals as clinical photography.        -  Multiple biopsies of the skin and lower intestine, and possibly the tumor in patients          with cancer, before starting treatment, at 2 weeks of treatment and at 8 weeks of          treatment.        -  Blood and urine tests every week while on treatment for the first two cycles, then every          4 weeks for patients who continue treatment beyond two cycles.        -  Imaging studies, such as computerized tomography (CT), ultrasound or magnetic resonance          imaging (MRI) in patients with cancer before starting treatment and again every two          cycles to monitor the tumor size and location.   "
237934|NCT00971802|"     To evaluate the safety and tolerability of PF-03882845 in Healthy Volunteers. To evaluate the     pharmacokinetics of PF-03882845 in Healthy Volunteers. To evaluate the pharmacodynamics of     PF-03882845 in Healthy Volunteers.   "
237935|NCT00971815|"     Chronic stress has been proposed to be involved the development of western life-style     diseases such as cardiovascular disease and type 2 diabetes (T2DM). At the same time chronic     stress is also believed to cause psychiatric disease such as melancholic depression (MD)and     anxiety disorders.      Accordingly, humans born with low birth weight (LBW) (ei. less than 5,0 LB) display an     increased risk for T2DM and MD. Studies suggest stress and adrenal stress hormones     (glucocorticoids) (GCC) might be involved in the development of both of these conditions.      Recent studies of animals born LBW suggest, that SSRI-compounds, usually employed in the     treatment of MD-related diseases, reduces stress-responses and levels of stress hormones such     adrenal steroids and at the same time has a positive influence on glucose metabolism.      In present study, the investigators aim to measure levels of GCC and stress and assess     glucose metabolism in healthy young men (20-35 years) born LBW (40 subjects). The volume and     structure of a certain brain area (ie. hippocampus) involved in regulation of adrenal GCC and     known to be malfunctioning in chronically stressed individuals will be assessed by magnetic     resonance imaging (MRI). Further metabolic examination will be accompanied by MRI     spectroscopy of liver and muscle fat content as well as total fat content (Dexa-scanning) and     contents of fat in the abdomen (by MRI) . Psychiatric well-ness and symptoms will be     characterized by well-established questionnaires such as MDI and SCL-92 and responses as     regards blood pressure, heart rate and changes in basal plasma concentrations of GCC and     Epinephrine will be assessed while performing a Stroop Stress Test. Finally, a 24 hour blood     pressure profile test will be included.      After this extensive examination program, subjects will be randomized to 3-4 months of     treatment with either Escitalopram (an SSRI-compound) or Placebo. Subsequently, at the end of     the treatment, the whole examination program will be repeated to detect potential beneficial     changes.      A group of young normal birth weight men (20 subjects) will serve as a healthy baseline group     for comparison and will not be exposed to any medical treatment.      This trial will add understanding to the mechanism underlying the development of type 2     diabetes and depression in LBW. Additionally, present trial might be capable of proposing a     novel treatment strategy to prevent the development of these diseases in LBW man.   "
237936|NCT00971828|"     This study will be co-ordinated by Dr Hector Chinoy, Dr Robert G Cooper (Salford Royal NHS     Foundation Trust / The University of Manchester) and Dr Ian N Bruce (Central Manchester     University Hospitals NHS Foundation Trust/ The University of Manchester). An initial pilot     study will be completed, to establish proof of concept of the study and to examine whether     trends may observed of differences between cases and controls.      Twenty five prevalent UK Caucasian adult IIM cases, confirmed by internationally accepted     criteria, will be recruited via the Adult Onset Myositis clinic, Salford Royal NHS Foundation     Trust. Age, gender and race-matched controls will be recruited on a 'best friend' system. At     the Wellcome Trust Clinical Research Facility (WTCRF), The University of Manchester,     facilities are already available for B-mode ultrasound CIMT measurement, Endo-PAT, lean body     mass measurement and contrast echocardiography. Cases and controls will have their     cardiovascular risk factors assessed using a standardised questionnaire and blood tests.     Further tests performed will include blood pressure, electrocardiogram, lean body mass,     B-mode ultrasound CIMT measurement and Endo-PAT. IIM cases will have additional blood tests     and a clinical assessment to assess their disease status, and contrast echocardiography. As     part of a linked study, subjects (but not controls) will also have Gd-DTPA-MRI of the heart     performed.   "
237937|NCT00971841|"     The purpose of this study is to provide access to paclitaxel therapy to subjects with     advanced or recurrent esophageal cancer who have completed the previous Phase 2 study     (CA139-540) and who should continue on therapy with paclitaxel as assessed by the treating     investigator(s). To evaluate the severity of observed adverse reactions in treated subjects     for assessment of long-term safety.   "
237938|NCT00971854|"     Deep brain stimulation (DBS) involves placing electrodes into the brain. Through these     electrodes, artificial electrical signals are chronically delivered into deep brain regions     in order to alter abnormal brain activity. The artificial electrical signals are generated by     a battery that is inserted under the skin of the chest. DBS is used to treat several     disorders of movement, including dystonia. In dystonia, the electrodes are inserted into a     brain region called the globus pallidus.      Globus pallidus stimulation can be very effective therapy for dystonia. However not all     patients are equally responsive and therapeutic outcomes can be frustratingly variable. The     reason for this variability is unclear. Such variability in response may need to be met by     tailoring stimulation to individual patients.      Another issue with deep brain stimulation is battery life. Eventually, batteries become     depleted and need to be replaced. Such battery replacements require an operation, hospital     stay and the risk of introducing infection. The high electrical energy that has been used to     treat dystonia means that batteries are typically replaced every year or two.      The artificial electrical signals of deep brain stimulation are delivered with three     parameters; frequency (Hertz - Hz), voltage (volts) and pulse width (microseconds). It has     recently been reported that lower frequency stimulation, at 60Hz rather than 130Hz, can be     used effectively to treat dystonia. Such 60Hz stimulation may be more effective for some     patients than others. The lower energy demands of 60Hz stimulation would also greatly improve     battery life (potentially doubling battery life).      The aim of this study is to assess if 60Hz stimulation is more effective in ameliorating the     dystonia of patients who have responded poorly to 130Hz pallidal stimulation. The current     status of the evidence is one of clinical equipoise (uncertainty) and therefore suits a     double blinded randomised trial.   "
237939|NCT00971867|"     The purpose of this study is to provide access to paclitaxel therapy to subjects with     advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388)     and should have continued therapy with paclitaxel as the discretion of the investigator, and     to evaluate the frequency and the severity of observed adverse reactions in treated subjects   "
237961|NCT00972153|"     The objective of this study is to determine whether the Air Barrier System device reduces     airborne particulate and airborne colony forming units present at a surgery site.   "
237940|NCT00971880|"     Patients suffering from Thalassemia or another hemoglobinopathies required regular blood     transfusions. The complications and adverse effects of blood transfusions can be classified     as immediate and late. Among the immediate effects the most common are allergic reactions and     fever, besides congestive heart failure in patients with cardiomyopathy. The late effects are     mostly related to blood transmitted infections like HIV or Hepatitis C infections.      The purpose of this study is to summarize the data of those complications in a cohort of 100     patients receiving regular blood transfusion.   "
237941|NCT00971893|"     The present study is designed to collect data on real world experience on use of Medrol in     acute asthma in Indian patients.   "
237942|NCT00971906|"     This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate     immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new     swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly     subjects. A booster dose will be administered 12 months after the first vaccination.   "
237943|NCT00971919|"     RATIONALE: Learning about chronic pain in women who have undergone surgery for breast cancer     may help improve the quality of life for these patients and may help doctors plan the best     treatment.      PURPOSE: This clinical trial is studying chronic pain in women who have undergone surgery for     stage I, stage II, or stage III breast cancer.   "
237944|NCT00971932|"     The primary objective of this trial is to assess the antitumor activity of cetuximab when     given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of     recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese     subjects.   "
237945|NCT00971945|"     The purpose of this study is to evaluate the safety and efficacy of continued administration     of paclitaxel given weekly in subjects considered to need to continue treatment after     completion of the preceding Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with     Advanced Breast Cancer (Protocol No. CA139-371)   "
237946|NCT00971958|"     Background: Novel HIV prevention approaches are urgently needed in Botswana and elsewhere in     sub-Saharan Africa. Although adult male circumcision (MC) has been shown to reduce the     heterosexual acquisition of HIV by men by about 60%, MC in infancy is optimal for its     relative ease, lower cost and low rate of complications. We have conducted focus groups and     semi-structured interviews that suggest neonatal MC (< 28 days of life) would be an     acceptable public HIV prevention strategy in Botswana. The government of Botswana is     committed to scaling up MC services in the immediate future and they plan to include     neonates. Understanding decision-making around infant MC will be essential to maximize the     effectiveness of this HIV prevention strategy.      Specific Aims: The investigators propose to: 1) determine the acceptability and actual uptake     of neonatal MC in southeastern Botswana and identify barriers to uptake; 2) ascertain the     feasibility and safety of neonatal MC in Botswana; 3) Estimate what, if any, advantages would     exist for scale up of Mogen Clamp, Plastibell or AccuCirc with regard to human resources,     equipment needs, adverse events and acceptability to health-care providers and families in     Botswana.      Study Design and Schema: The investigators will conduct structured interviews with early     postpartum mothers and fathers to determine correlates of neonatal MC acceptability and     uptake, defined as neonatal MC following informed consent. Male infants will be circumcised     by a trained doctor in a hospital / clinic setting by one of three FDA-approved devices that     are currently in use in US hospitals: Mogen clamp, Plastibell or AccuCirc. Circumcision with     Mogen Clamp or Plastibell will be done before 29 days of life. Circumcision with AccuCirc     will be done before 11 days of life (FDA approval limit for device). The investigators will     also administer questionnaires to the parents at the regular pediatric follow-up visit(s) to     assess impressions of / satisfaction with the infant's procedure outcome over time. Provider     impressions of the three methods will also be evaluated. Sample size will be 150 infants per     arm for a total of 450 infants males circumcised (and an estimated 800 parental     questionnaires).      Public Health Significance: The World Health Organization (WHO) and UNAIDS state that     countries with severe, generalized HIV epidemics but low rates of MC should offer this     surgery as an important, evidence-based HIV prevention intervention, including among     neonates. These two agencies also recommended that additional research on the most feasible,     safe, and sustainable ways of scaling up MC intervention should be performed. This study will     be in keeping with these recommendations.      Please note the Mogen clamp and Plastibell study arms began as a randomized trial before the     initiation of the AccuCirc single-arm portion. Although the settings in which the three     devices were studied were similar, the AccuCirc trial enrollment began at two sites (Gaborone     and Molepolole) only after completion of the Mogen clamp and Plastibell arms, which was     conducted in three sites (Gaborone, Molepolole and Mochudi). Although Lobatse was a site for     the first acceptability study with mothers, no procedures were performed there.      Regarding the reported sample size: the total, final sample size includes both parents of     newborn boys (because enrolled consenting parents completed questionnaires as part of this     study), and boys whose parents consented to circumcision. We anticipated that not all parents     who completed the questionnaire would consent to circumcising their baby; therefore, when     planning the study it was necessary to estimate the number of parents who would participate     in the survey (700), to achieve an enrollment of 300 neonates (therefore the initial estimate     of 1000). The original study in fact enrolled 302 infants, 600 mothers and 19 fathers (total     study population 921). The addition of the AccuCirc arm led to a revised estimate of total     number of neonates and their parents (total=1250). The final enrollment was of 1,235     participants, that includes all the participating neonates and parents.   "
237947|NCT00971971|"     Intradialytic hypotension (IH) is a major complication during acute hemodialysis. The aim of     this study was to evaluate the effects of dialysate temperature (DT) reduction with Na and     ultrafiltration (UF) profiling on hemodynamics of critically ill acute kidney injury (AKI)     patients submitted to sustained low-efficiency dialysis (SLED).   "
237948|NCT00971984|"     The study intends to summarize the clinical and laboratory characteristics of children with     hemolytic anemia diagnosed as having alpha thalassemia mutations.   "
237949|NCT00971997|"     The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c)     level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day     (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic     control on oral antidiabetic drugs (OADs).   "
237950|NCT00972010|"     The purpose of this research study is to find out more about distinguishing between cancerous     and non-cancerous breast cancer cells at the edges of tumors. Using an FDA approved device to     remove tumors, this device will be tested to see if it causes less tissue damage and     therefore makes it easier to examine the tumor and make sure it is all excised. The tumors     will be excised by standard surgical technique, and then the effects of the device on the     removed tissues will be studied.   "
237951|NCT00972023|"     RATIONALE: Dehydroepiandrosterone (DHEA) may slow the growth of tumor cells and be an     effective treatment for women with breast cancer.      PURPOSE: This phase I trial is studying how well DHEA works in treating women undergoing     surgery for stage I, stage II, or stage III breast cancer.   "
237952|NCT00972036|"     This study is being done with a new therapy called Selective Internal Radiation Therapy     (known as SIRT). Radiation is an effective treatment for destroying tumors. It is widely used     in cancer treatment. However, radiation can harm normal tissue. SIR-Spheres are tiny plastic     beads. They contain a radioactive agent called Yttrium-90. These beads can be delivered     through a small tube inserted into the blood vessel that goes directly to the tumor. The     radiation goes directly to the tumor. This spares healthy parts of your liver.   "
237953|NCT00972049|"     The primary purpose of this study is to assess the safety and tolerability of AZD2516     following administration of a single dose to Japanese healthy subjects.   "
237954|NCT00972062|"     The purpose of this study is to determine if an herbal over-the-counter cream can decrease     skin site reactions in multiple sclerosis patients who currently take either Betaseron,     Copaxone or Rebif as their subcutaneous medication for managing their multiple sclerosis.     Injection site reactions have been indicated as one of the major reasons for discontinuing     treatment with the subcutaneous medications (Betaseron, Copaxone, and Rebif) for multiple     sclerosis.   "
237955|NCT00972075|"     The aim of this placebo-controlled randomized study was to evaluate the efficacy of Circadin™     2 mg in improving total night sleep duration and stabilizing the circadian clock phase in     totally blind subjects with non-24 hour sleep-wake disorder.   "
237956|NCT00972088|"     To show that prevalence of inflammation of the small bowel in patients with anorectal disease     is under-diagnosed based on colonoscopy ileoscopy alone.   "
237957|NCT00972101|"     The goal of this clinical research study is to learn if treating umbilical cord blood with     growth factors before a transplant can help to improve the body's ability to accept the cord     blood transplants.   "
237958|NCT00972114|"     The purpose of this study is in a phase I/II safety and efficacy study to evaluate the     clinical effect of coronary artery bypass graft (CABG) combined pedicled omentum wrapped     autologous atrial tissue patch cardiomyoplasty for patients with ischemic cardiomyopathy.   "
237959|NCT00972127|"     Primary:        -  To assess the influence of acidified urinary pH on the renal excretion of Neramexane      Secondary:        -  To assess the influence of acidified urinary pH on the renal excretion of N-OH          Neramexane        -  To assess the steady state plasma pharmacokinetics (PK) of Neramexane and N-OH          Neramexane under physiological conditions and under the conditions of urine          acidification        -  To assess safety and tolerability of a repeated dose treatment of Neramexane under          physiological conditions and under the conditions of urine acidification   "
237960|NCT00972140|"     The purpose of this study is to demonstrate the clinical equivalence of formoterol-HFA pMDI     12µg/actuation administered twice daily to formoterol DPI 12µg/capsule delivered by the     Aerolizer inhaler and administered twice daily in patients with COPD.   "
237962|NCT00972179|"     This study will follow a randomized, multiple-dose, double-blind, placebo-controlled,     sequential dose-escalation study design. This healthy volunteer study will consist of five     subcutaneous (SC) cohorts and one intravenous (IV) cohort. Each dose cohort will enroll 8     subjects, randomized such that 6 subjects will receive AMG 157 and 2 will receive placebo     (3:1 ratio). The doses of AMG 157 planned to be evaluated include 35 mg (SC every 28 days,     Cohort 1), 105 mg (SC every 28 days, Cohort 2), 210 mg (SC every 28 days, Cohort 3), 210 mg     (SC every 14 days, Cohort 4), 210 mg (SC every 7 days, Cohort 5) and 700 mg (IV every 28     days, Cohort 6).   "
237963|NCT00972192|"     This study compared the effectiveness of inpatient routine VCT to referral for post-discharge     VCT in terms of the number of new HIV infections identified, linkage to care for HIV infected     individuals and reduction in HIV risk behavior.   "
237964|NCT00972205|"     Background:        -  Some cancer cells have a large amount of a protein called P-glycoprotein, which can pump          certain chemotherapy drugs out of their cells. This pump may be part of the reason why          it is difficult to shrink some cancers with chemotherapy.        -  In laboratory experiments, the drug CBT-1(Registered Trademark) blocked the          P-glycoprotein pump, resulting in accumulation of higher amounts of chemotherapy inside          the cancer cells, making the chemotherapy more effective.        -  Paclitaxel is a cancer drug that has caused tumors to shrink in many types of cancers,          including lung, ovarian, breast, renal, cervical and others.      Objectives:        -  To determine whether CBT-1(Registered Trademark) can block the P-glycoprotein pump on          cancer cells and whether it inhibits the action of the pump found in normal blood cells          and liver tissue.        -  To evaluate the effectiveness of combination therapy using CBT-1(Registered Trademark)          and paclitaxel in treating solid tumors and to determine whether the two drugs together          are more effective than paclitaxel alone.      Eligibility:      -Patients over 18 years of age who have a solid tumor that cannot be treated successfully     with standard treatments.      Design:      -Patients receive CBT-1(Registered Trademark) and paclitaxel in 21-day cycles. Treatment     continues for two cycles after all the cancer is gone, or until it is decided to surgically     remove some or all of the remaining cancer, or until the cancer has grown to the point where     it defined as progressive disease.      For each cycle, patients take CBT-1(Registered Trademark) by mouth in three divided doses     daily for 7 days. On day 6, paclitaxel is given through a vein over 3 hours.      Blood tests are done before starting CBT-1(Registered Trademark) and repeated periodically     throughout treatment.      Imaging studies computed tomography or magnetic resonance imaging (CT or MRI) are done every     two cycles. In addition, for the first cycle only, patients undergo imaging of tumors and     normal tissue with a 99mTc-sestamibi radionuclide scan before and after administration of     CBT-1(Registered Trademark). This scan helps show how well the P-glycoprotein pump is being     blocked by the treatment.   "
237965|NCT00972218|"     Adalimumab is an antibody treatment that targets and neutralizes a molecule produced in the     body that is associated with inflammation, tumor necrosis factor (TNF). This molecule is an     important factor in causing the inflammation seen in people with a form of inflammatory     spinal arthritis called spondylitis as well as inflammation in the bowel called Crohn's     disease. Spondylitis and Crohn's disease tend to go together and this study will assess to     what degree this treatment is effective for those patients that have both disorders at the     same time.   "
237966|NCT00972231|"     Iron overload impaired growth in Thalassemia patients due to iron deposition in the endocrine     glands, including the hypophysis and gonads. The issue of iron overload in Sickle Cell Anemia     is recently studied more extensively and preliminary studies shows that endocrine damage is     rarer in those patients.      Growth velocity was not systematically studied in patients with Iron Overload, even in     thalassemia patients in spite several studies that assess the endocrine function in those     patients. In Sickle Cell Patients this issue was not studied.      The purpose of this study is to assess the growth velocity in a cohort of Thalassemia Major     and Intermedia patients and compare the results to another group of Sickle Cell patients,     including Sickle cell thalassemia.   "
237967|NCT00972244|"     The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in     Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of     dapagliflozin to placebo when given in oral doses.   "
237968|NCT00972257|"     The proposed study will compare for the first time the quality of 24-hour IOP control with     Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination     (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may     determine the real efficacy of the two fixed combinations and the design of the proposed     study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less     than might be anticipated.   "
237969|NCT00972270|"     This is a randomized trial investigating the use of the IMPELLA RECOVER LP 2.5 compared to     Intra-aortic balloon pump (IABP) in patients with Acute Myocardial Infarction.   "
237970|NCT00972283|"     This trial is conducted in Africa, Asia, Europe, and the United States of America (USA).      The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin     glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without     pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the     long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with     or without metformin and with or without pioglitazone in subjects with type 2 diabetes.      All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial     participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.      Subjects who consent to participate in the extension trial (NN1250-3667) will continue to     receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582.      The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension     period is registered as NN1250-3667.   "
237982|NCT00972439|"     The purpose of this research study is to gain a better understanding of the changes that may     occur in the breast when a woman uses an oral contraceptive (birth control pill). Some     research indicates that women who use birth control pills with lower amounts of progestin (a     hormone in the birth control pill) may have lower breast cell growth than women who use birth     control pills with a higher amount of progestin; this research will examine that in detail.   "
237983|NCT00972452|"     The investigators wish to determine whether a short period of exercise training (5-10 days)     improves the metabolic and cardiovascular response of people with or at risk of developing     type 2 diabetes to eating a meal. In healthy people, blood flow to skeletal muscles increases     after eating a meal, and this helps to regulate blood sugar levels by delivering blood sugar     to muscles where it can be stored or metabolized. In people with or at risk of type 2     diabetes, blood flow does not increase as much after eating a meal, and this may contribute     to elevated blood sugar concentrations observed in these individuals. The investigators wish     to determine whether exercise can improve this response.   "
238010|NCT00972803|"     Dental plaque is a well known etiologic factor for gingivitis. Recently, herbal extracts are     a matter of scientific interest to inhibit plaque accumulation on teeth. The purpose of this     study was to evaluate the effects of pistacia Mutica (PM) mouth wash on de novo dental plaque     plaque formation, gingival inflammation indices and oral microorganisms.   "
237971|NCT00972296|"     This project proposes to examine the difference in effectiveness of fracture boots and carbon     fiber braces in the management of gait abnormalities and pain relief due to ankle pain from     arthritis due to ankle bleeds. Fracture boots are walking casts that you can put on and     take off. They prevent the ankle from moving and have a curved sole to mimic normal walking.     They can help relieve pain of ankle arthritis from ankle bleeds by stopping ankle motion and     absorbing some of the body's own weight while walking. Carbon fiber braces use newer     technology resulting in lighter and smaller braces. They are designed to assist with helping     clear the toe and straighten the knee while walking.      Gait analysis wearing both the fracture boot and carbon fiber brace will be performed by     walking on a mat equipped with pressure sensors and will examine the effect of the fracture     boot and the carbon fiber brace on how you walk. These tests will be compared to walking on     the mat without either brace. The sensors on the mat will measure different aspects of gait     such as step length and foot position. You will be asked questions about how much ankle pain     you have using no brace compared to each brace.      People with hemophilia A or B and ankle pain from bleeds will be asked to participate. They     will be approached during routine clinic visits and will also be contacted by telephone.      Levels of pain will be measured before, during and after each trial using standardized visual     analog and ordinal pain scales. Measurements from the gait mat and levels of pain relief will     be used to determine effectiveness of each type of support.      Statisticians will be used to analyze results of the gait mat and pain scale measurements.   "
237972|NCT00972309|"     Background:        -  PSA (prostate specific antigen) is a protein found on normal and cancerous prostate          cells. Levels of this protein are used to identify men who are at risk for prostate          cancer and to monitor responses to treatment in men who have been diagnosed with          prostate cancer.        -  Research has shown that men who continue to have an elevated PSA level following primary          treatment for prostate cancer are at increased risk for cancer progression. Studies have          shown that the change in PSA levels over time, or PSA doubling time (PSADT), can be          accurate in predicting how quickly the cancer is likely to progress. Individuals with a          PSADT of less than 3 months are at extremely high risk for disease progression and death          from prostate cancer. Individuals with a PSADT of greater than 15 months have a very low          risk of death from prostate cancer.        -  TARP is a protein that is found in about 95% of prostate cancers and is known to          stimulate the immune system. The TARP prostate cancer vaccine is made from pieces of the          TARP protein called peptides and includes peptides that have been modified to make them          more effective at stimulating immunity. Although these TARP peptides have been shown to          stimulate the immune systems of mice, information is needed to determine if they also          stimulate the immune system in humans. Since it is unclear what is the best way to give          peptide vaccines, the TARP peptides will be given with substances known to stimulate the          immune system or in a vaccine made with the patient s own cells.      Objectives:        -  To determine the immune system s response to vaccination with TARP peptides.        -  To determine the safety and toxicity of TARP peptide vaccination.        -  To determine if vaccination with the TARP prostate cancer vaccine can slow down PSADT in          men with an intermediate PSADT of 3 to 15 months.      Eligibility:        -  Males 18 years of age and older who have completed their primary treatment for prostate          cancer, have stage D0 disease, are HLA A*0201 positive and who have a PSADT greater than          3 and less than 15 months.      Design:        -  Patients will be randomized to one of two treatment arms:        -  Arm A will receive the TARP vaccine with other substances that stimulate the immune          system.        -  Arm B will receive the TARP vaccine that includes a patient s own white blood cells.        -  First week of study, after screening for eligibility has been completed:        -  Day 1: Apheresis procedure to extract white blood cells to test the immune response to          the vaccine.        -  Day 3: Flu vaccine to allow researchers to determine how well a patient s immune system          is working.        -  Clinic visits in Weeks 3, 6, 9, 12, and 15 for physical examination, blood samples, and          administration of the TARP peptide vaccine.        -  Physical examination and blood samples only in Weeks 18 and 36.        -  Additional blood samples and apheresis procedures in Weeks 24 and 48.        -  A 6th dose of TARP peptide vaccine will be administer to those patients who have a          response to vaccination at week 24.        -  No follow-up or long-term study is associated with this study.   "
237973|NCT00972322|"     This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering     activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study     is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted     mean glucose (WMG) from baseline than placebo.   "
237974|NCT00972335|"     In this multicenter, Phase II trial, the investigators plan to evaluate the activity of the     combination of bevacizumab and everolimus in patients with recurrent, progressive meningioma     following maximal treatment with surgical resection and local radiation therapy. Although     these patients are relatively rare, there is currently no established standard of treatment     for a disease that causes a great deal of morbidity, and that is eventually fatal.   "
237975|NCT00972348|"     This is a research study to determine if a personal health record, called myHERO, will help     improve health. A personal health record is a secure internet (also called online) tool that     contains personal health information like medications, diagnosed conditions, allergies and     laboratory values (like CD4 cells and viral load). This study will also help explain if a     personal health record influences the relationship with a doctor or nurse practitioner and     their patients. The purpose of this study is to determine if a personal health record will     influence health. The content of your personal health record is as secure as possible for any     online health information.   "
237976|NCT00972361|"     Routine analysis of coagulation profile is recommended before adenoidectomy, tonsillectomy or     ventilation tubes insertion in children.      A proportion of those children reveal borderline abnormal values of Partial Prothrombin Time     (aPTT) or Prothrombin Time (PT) and then they are referred to a consultant hematologist for     further evaluation and recommendations before surgery.      The purpose of this study is to summarize the causes of referrals in a cohort of 200 children     and to assess the further laboratory analysis preformed and the results obtained.   "
237977|NCT00972374|"     This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200     μg and 400 μg brimonidine tartrate) on visual function in patients with previous     rhegmatogenous macula-off retinal detachment.   "
237978|NCT00972387|"     The purpose of this study is to assess whether the greater performance benefits from     ingesting carbohydrate-protein supplements during endurance running, in comparison to the     traditionally used carbohydrate supplement, is attributed to the extra calories contained in     the carbohydrate-protein supplement or the presence of protein.   "
237979|NCT00972400|"     RATIONALE: Gathering information over time from blood samples and measurements of activity,     sleep, mood, and cognition may help doctors learn more about fatigue in breast cancer     survivors and plan the best treatment.      PURPOSE: This clinical trial is studying fatigue in breast cancer survivors.   "
237980|NCT00972413|"     The primary aim of this study is to investigate the use of cone beam computed tomography     (CBCT) for breast imaging in the diagnostic setting by providing a compelling body of     evidence incorporating both non-contrast and contrast enhanced CBCT in the study protocol.     The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the     diagnostic work-up of breast lesions.   "
237981|NCT00972426|"     The primary objective of the clinical study is to evaluate the efficacy and safety for     Mikelan LA eye drops 2% (once per day) of intra-ocular pressure decreased.   "
238011|NCT00972816|"     This study will evaluate the safety and immunogenicity of different combinations of A/H1N1     S-OIV (swine flu) vaccine in healthy young children.   "
237984|NCT00972465|"     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in     the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical     efficacy has been shown in adult with head and neck cancer. The study assessed the safety,     and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy     in patients with advanced colorectal cancer.   "
237985|NCT00972478|"     This phase I/II trial is studying the side effects and best dose of vorinostat when given     together with rituximab and combination chemotherapy and to see how well it works in treating     patients with newly diagnosed stage II, stage III, or stage IV diffuse large B-cell lymphoma.     Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as     rituximab, can block cancer cell growth in different ways. Some block the ability of cancer     cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing     substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin     hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth     of cancer cells, either by killing the cells or by stopping them from dividing. Giving     vorinostat together with rituximab and combination chemotherapy may kill more cancer cells.   "
237986|NCT00972491|"     Laryngeal mask airway (LMA) is routinely used for some patients who have surgery under     general anesthesia. LMA is placed in the mouth and allow the anesthesia to be given without     having to put a breathing tube in the throat. Previous studies have focused on the effect of     different anesthesia medicines on optimal condition for LMA use. The objective of the present     study is to find the optimal time for LMA insertion.   "
237987|NCT00972504|"     This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess     the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg)     and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal     allergic rhinitis.   "
237988|NCT00972517|"     The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'     investigational vaccine GSK2340272A in children aged between 3 and 17 years.   "
237989|NCT00972530|"     BACKGROUND: Intra-articular glucocorticoid injections are frequently used to relieve symptoms     of arthritis. Postinjection rest has been shown to improve the outcome of knee joint     injections, but not for wrist injections. Consequently, different joints respond differently     on postinjection regimens.      OBJECTIVES: To investigate whether better treatment results might be achieved of     post-injection rest following intra-articular glucocorticoid treatment for elbow synovitis.      METHODS: 90 patients with rheumatoid arthritis (RA) and elbow synovitis were treated with 20     mg intra-articular triamcinolone hexacetonide and randomised to either a 48 hour     immobilisation in a triangular sling (n=46) or normal activity without restrictions (n=44).     Primary endpoint was relapse of synovitis. In addition, pain, function according to a self     assessment questionnaire (PREE) and range of movement were followed for six months.   "
237990|NCT00972543|"     The primary purpose of the study is to evaluate the safety and efficacy of Raptiva® compared     to placebo in controlling moderate to severe chronic plaque psoriasis involving palms and/or     soles scoring Palmo-plantar Pustular Psoriasis Area and Severity Index (PPPASI) ≥5 in     subjects that are candidates for phototherapy or systemic therapies.      The rational of the trial is that psoriasis involving palms and/or soles is a painful     condition associated with fissuring, scaling and in some instances with pustulation. Because     of its localization, it is a disabling condition that limits dexterity and affects social     interaction, leading to compromised quality of life; and this confers additional severity to     that of plaque psoriasis on the body. The therapeutic approach for palm and sole plaque-type     psoriasis usually begins with topical corticosteroid treatment. If the disease reaches a     certain extent, the next step involves the addition of systemic treatments. Substances like     methotrexate, retinoids and cyclosporine have shown to be efficacious, but their long-term     usage is often limited by toxicity. Biologic treatments for psoriasis avoid this toxicity and     offer a new therapeutic approach.      The therapeutic potential of Raptiva® to treat palm and sole psoriasis refractory to systemic     treatments has been described in numerous case reports and in one placebo-controlled phase IV     study. However, in all cases, the number of subjects included was low, and in most cases the     trials were not prospectively designed.      Since the efficacy of Raptiva® on psoriasis of palms and soles must be determined using the     validated PPPASI measure, it is necessary for scientific and ethical reasons to include a     placebo arm during the first 12 weeks. Finally, as the clinical response may sometimes take     longer than 12 weeks, subjects must be treated and evaluated during an additional 12-week     open-label extended treatment period.   "
237991|NCT00972556|"     This prospective clinical randomized controlled trial is established to compare the clinical,     radiographic, and histological treatment outcomes between MTA and FC in pulpotomized human     primary molars at 6, 12, 18, 24 month post-treatment and to test the hypothesis that Gray     Mineral Trioxide Aggregate (GMTA) is a viable alternative to Diluted (20%) Formocresol (DFC)     in pulpotomies treatment of human primary molars.   "
237992|NCT00972569|"     The purpose of the study is to determine if low doses of BNP can improve renal function in     people with chronic heart failure with renal dysfunction, also to determine whether     Sildenafil assists with improvement. This study will enroll only hospitalized patients with     heart failure.   "
237993|NCT00972582|"     When dietary amino acid supplements are consumed by humans they are normally in addition to     their normal daily requirements. The investigators' laboratory played a leading role in     defining the estimated average requirement (EAR) and the recommended dietary intake for the     essential amino acids (Dietary Reference Intakes 2005). The other important but less well     studied component of Dietary Reference Intakes (DRI) is - What is a safe upper limit of     intake? The investigators now propose to determine the safe upper limits of the dietary     essential amino acids. The recently published DRI (2005) defines the Tolerable Upper Intake     Level (UL) as 'the highest average daily nutrient intake level that is likely to pose no risk     of adverse health effects to almost all individuals in the general population.' As intake     increases above the UL, the potential risk of adverse effects may increase'. In this     proposal, the investigators define a novel method to define the safe upper limit where the     'maximum oxidative potential' of an amino acid identifies the 'metabolic limit' to dispose     the amino acid. Intakes of amino acid above this level will increase the potential for     adverse effects to appear.   "
237994|NCT00972595|"     This study will assess the bioequivalence of a Merck clinical trial formulation of     ondansetron compared to a non-U.S. marketed formulation of ondansetron.   "
238009|NCT00972790|"     The objective of this study is to demonstrate that scalp nerve blocks (scalp freezing),     performed at the end of supratentorial brain surgery, will reduce post-operative pain,     opioids side effects, and the time required for post-anaesthesia care unit (PACU)/Intensive     Care Unit (ICU) and hospital discharge.   "
237995|NCT00972608|"     The purpose of this study is to utilize cardiac imaging data acquired as part of the standard     of care for these patients, such as MRI, 3D echo, and CT, and existing 3D reconstruction     protocols to assess the feasibility of using surgical planning in the treatment of patients     with complex cardiac defects. The specific aims of the project are as follows:        1. Develop a protocol to reconstruct heart models from patient imaging data and perform          virtual surgery on reconstructed 3D anatomy using appropriate, pre-existing patient          datasets.        2. Use the developed protocol to prospectively plan and evaluate the possible surgical          options for new patients.        3. Validate that the optimal virtual anatomy agrees with what was surgically implemented          using post-operative patient scans, when available.   "
237996|NCT00972621|"     The purpose of this study is to evaluate the safety and effectiveness of a new opthalmic     viscoelastic material for the use in cataract surgery. The new viscoelastic will be compared     to a currently marketed viscoelastic material.   "
237997|NCT00972634|"     RATIONALE: A computer-based system for assessing symptoms may be effective for patients with     metastatic or advanced cancer.      PURPOSE: This clinical trial is studying how well computerized questionnaires work in     assessing symptoms, pain, depression, and physical function in patients with metastatic     and/or advanced local/regional cancer.   "
237998|NCT00972647|"     Introduction: The orthopaedic surgeon is frequently exposed to ionizing radiation, especially     during intraoperative fluoroscopy. It is expected that using a laser guided fluoroscopy     technique, which should improve accuracy of radiography, should also reduce the amount of     time of exposure to radiation. Finally, the literature appears controversial in this matter     with no clear conclusions that could be drawn from such.      Hypothesis: The test hypothesis is that the use of the laser-aiming device for fluoroscopy in     several orthopaedic procedures will reduce the exposure of the patient and the surgeon to the     damaging effects of radiation. The null hypothesis then states that there will be no     difference in exposure to radiation between the group using the laser device and the group     not using the apparatus.      Methods: A prospective randomized controlled trial will be performed in which patients     undergoing fluoroscopy will be randomly allocated to two groups. One group will undergo     imaging with use of the device throughout the procedure and the other group will undergo     radiation without the laser guided device. Number and time of exposure will be recorded for     each procedure. It is of the utmost importance that the complexity of the procedures remains     relatively similar. It is believed that a good measure of complexity is the surgical time.     Therefore, any procedures that are statistically similar from a set mean (p > 0.05) would be     included into the study. It is also important that one or two surgeons with similar expertise     and years of experience perform the surgeries to avoid confounding factors. It is expected     that throughout the duration of the study (8 weeks) 50-100 cases would be reported which     would produce statistically significant results. The results will be analyzed by calculating     confidence intervals and differences between means of continuous data and significance levels     by the Student's t test. Statistical significance will be set to P < 0.05.      Risks and Benefits: This study involves minimal risk. The use of the laser guide will not     increase or introduce any risks other than the associated inherent surgical risks. The risks     usually associated with this type of studies concern breach of confidentiality. To reduce     this risk, research numbers will be assigned to subjects' data collected during the     procedure, whose personal information will be found in another password-protected database.      This study will help the investigators to investigate a technique that may help reduce the     amount of time that a patient is exposed to radiation.   "
237999|NCT00972660|"     Study Design: Treatment, Randomized, Open Label, Parallel Assignment,Safety/Efficacy Study.      The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells     (MSC) expanded ex-vivo infusion for the treatment of patients who have developed a newly     diagnosed extensive or refractory chronic graft versus host disease (chronic GVHD) to the     usual therapeutic measures.   "
238000|NCT00972673|"     This is a randomized, double blind, placebo controlled, parallel-group, repeat dose study to     investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose     from a novel dry powder device in healthy Japanese male subjects.   "
238001|NCT00972686|"     P3K112826 is a Phase I, first-time-in-human dose escalation study in subjects with refractory     malignancy. The primary objective of this study is to determine the recommended Phase II dose     of GSK2126458 based on safety and tolerability, pharmacokinetics, pharmacodynamics and     preliminary evidence of clinical activity. Secondary objectives are to characterize the     pharmacokinetics of GSK2126458; and to explore relationships between GSK2126458     pharmacokinetics, pharmacodynamics, response prediction biomarkers and clinical endpoints.   "
238002|NCT00972699|"     The purpose of this study is to test a mother-to-mother intervention during pregnancy and     after delivery with Mothers Living with HIV (MLH)in South Africa. We hypothesize that the     intervention will enhance the adjustment of the children of MLH by improving the health and     mental health of MLH which benefits their children, as well as the MLH.   "
238003|NCT00972712|"     The purpose of this study is to test the effect of the combination of bortezomib and     tipifarnib. Bortezomib (VELCADE) is approved by the Food and Drug Administration (FDA) for     the treatment of multiple myeloma patients who have received at least one prior therapy.     Tipifarnib is not yet approved by the FDA and is an investigational drug. Investigational     means that the drug is still being studied and that research doctors are trying to find out     more about it. Because these drugs have not been used together before, it is not clear which     dose of each agent is optimal when used in combination.      This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     an investigational drug. Phase I studies also try to define the appropriate dose of the     investigational drugs to use for further studies. The investigators will test the safety of     BORTEZOMIB and TIPIFARNIB together and see what effects (good and bad) it has on you and your     MULTIPLE MYELOMA, and to find the highest dose of both agents that can be given without     causing severe side effects.   "
238004|NCT00972725|"     The purpose of this study is to evaluate the safety and reactogenicity of one booster dose of     a HIV candidate vaccine after administration of one oral dose of chloroquine.   "
238005|NCT00972738|"     This study will assess the treatment effect of montelukast versus placebo over a 2 week     period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an     active comparator.   "
238006|NCT00972751|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at protein expression in tumor tissue samples from     patients with stage II or stage III rectal cancer enrolled in clinical trial SWOG-9304.   "
238007|NCT00972764|"     The purpose of this study is to expose some of the factors that may be associated or     predisposing to development of laryngomalacia.   "
238008|NCT00972777|"     This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin     ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis.     This study was conducted as a phase IIb study and continued with further enrollment as a     phase III study.   "
238012|NCT00972829|"     Recently, research studies have shown that patients who have had trouble taking statins every     day, are able to take statins if they take them only once or twice a week. The investigators     are doing a research study which involves switching people who are taking ezetimibe to the     statin Crestor once or twice a week and to see how ell Crestor lowers cholesterol and if it     is tolerated.   "
238013|NCT00972842|"     A standard therapy is neither established in first-line patients nor in relapsed patients     with PTCL, and there is still an unmet medical need to identify novel efficacious and safe     therapy regimens.      The aim of this study is to evaluate the potential of a Lenalidomide plus Vorinostat and     Dexamethasone combination therapy as an effective and safe therapeutic regimen, in the     treatment of relapsed PTCL following failure of prior regimens.   "
238014|NCT00972855|"     The objective of this study is to compare the rate and extent of absorption of bicalutamide     50 mg tablets (test) versus Casodex® (reference) administered as 1 x 50 mg tablet under fed     conditions.   "
238015|NCT00972868|"     The purpose of this study is to determine the feasibility, safety and efficacy of a     unidirectional breathing mask (breathe in through the nose and out through the mouth or     breathe in through the mouth and out through the nose) in COPD patients with breathing     difficulties requiring noninvasive positive pressure ventilation (NPPV).   "
238016|NCT00972881|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy     uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy, cetuximab, and     radiation therapy before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed.      PURPOSE: This phase I/II trial is studying the side effects of giving capecitabine and     irinotecan hydrochloride together with cetuximab and radiation therapy and to see how well it     works in treating patients undergoing surgery for locally advanced rectal cancer.   "
238017|NCT00972894|"     The investigators are comparing three different methods of testing for an infection which is     commonly found in women. The infection is caused by a bacterium called Group B Streptococcus.     About 10−30% of women carry GBS in the vagina or rectum.      During labour this infection can be passed to the neonate. This can lead to the baby     developing a serious infection.      However, research has shown that if antibiotic treatment is given to GBS carrying women     during labour most of these infections can be avoided.      A new bedside test known as PCR has been shown to produce a GBS diagnostic result in less     than an hour. In clinical trials conducted in the US and France this method has been shown to     be more accurate than either prenatal vaginal swabs or risk factor assessment. For this     reason, PCR may be helpful in screening and treating GBS positive women in the UK.      In this study the investigators will compare each of the following three methods of diagnosis     to a gold standard.        -  Prenatal vaginal culture swab (at 35 to 37 weeks gestation)− The US approach.        -  Risk factor assessment (at the time of admission for labour)− The UK approach        -  The new PCR test (at the time of your labour admission)      The investigators will compare the accuracy of each of these methods with the most accurate     method for determining the GBS status during labour. This 'most accurate' method is a highly     sensitive swab test which unfortunately takes several days to produce a result. For this     reason this test will not tell the investigators whether prophylactic antibiotics may be     useful during labour (Receiving them after birth is ineffective).      If PCR is shown to be a more accurate method of identifying GBS positive women this may help     to reduce the number of infections in new born infants and as a result may help to save     lives.   "
238018|NCT00972907|"     This is an open label study. The study will consist of 1 treatment group: coated Nifedipine     suppository containing 12 mg of Nifedipine, administered BID to subjects with chronic anal     fissure.   "
238019|NCT00972920|"     Transversus abdominis plane (TAP) block is an application of local anaesthetic solution into     the plane between internal oblique and transversus abdominis muscles at the triangle of Petit     located superiorly to the iliac crests bilaterally. Anterior divisions of segmental spinal     nerves, which provide innervation to the abdominal wall, run inside this compartment. TAP     block been shown to provide good postoperative pain relief following surgical laparotomies,     gynaecological laparotomies, appendicectomies, inguinal hernia repairs and open     prostatectomies. The goal of this study is to compare the effect of blind and     ultrasound-guided TAP block on postoperative pain relief and morphine consumption following     to gynaecological laparotomies. Null research hypothesis for the study is that there is no     difference between the performance (as defined by morphine consumption and patient     satisfaction/ pain scores) of the TAP block procedure via 'blind' or ultrasound guided     techniques for gynaecological laparotomies.   "
238020|NCT00972933|"     Ipilimumab is a manufactured monoclonal antibody, much like the antibodies usually made by     the human body to fight off infection; however it is not known why the human body does not     fight off a cancerous tumor. The idea behind developing this experimental drug is to     stimulate the immune system to make antibodies to kill cancer cells. This research study is     considered experimental because it has not received approval from the Food and Drug     Administration (FDA) for the treatment of this type of cancer.      This monoclonal antibody has been specifically made to block Cytotoxic T Lymphocyte Antigen 4     (CTLA4), which is a protein found on cells of the immune system. CTLA4 seems to slow down the     immune response, so blocking it with an anti-CTLA4 antibody may make the immune response more     active. The purpose of this study is to see if Ipilimumab affects the response of the     patient's immune system toward their cancer.   "
238035|NCT00973128|"     The present study was designed as a randomized, single blind, placebo-controlled, study to     evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and     associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d     for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat     cutaneous leishmaniasis ulcers.   "
238036|NCT00973141|"     The purpose of this study is to compare the safety and effectiveness of different doses of     JNJ-42160443 with placebo in the treatment of chronic, moderate to severe knee or hip pain in     patients with a diagnosis of osteoarthritis.   "
238021|NCT00972946|"     The ability to label specific cells and image their natural movements in vivo would allow     researchers to investigate the mechanisms of disease progression. In addition, cell-based     therapy, especially stem cell therapy, requires non-invasive monitoring of transplanted cells     to follow their bio-distribution and biological function. Because of recent interest in stem     cell treatment, several methods have been investigated for in vivo cell tracking. The     investigators propose to assess whether the magnetic resonance imaging (MRI) contrast agent     Endorem (superparamagnetic particles of iron oxide) can be used to label cells for in vivo     tracking using MRI. The investigators will use 20 healthy human volunteers to:        1. Assess the feasibility of imaging Endorem-labelled cells in vivo        2. Compare the distribution of Endorem-labelled cells with that of intravenous injection of          Endorem   "
238022|NCT00972959|"     The aim of this study is to evaluate the effect of bortezomib in combination with     dexamethasone and zoledronic acid on bone mineral density (BMD) and skeletal related events     (SREs) in Patients with Multiple Myeloma who Have Relapsed after 1-3 Prior Lines of Therapy   "
238023|NCT00972972|"     The purpose of this study is to determine whether dietary intervention with blueberry and     grape juice extracts in elderly men with subjective memory problems would raise performance     on neuropsychological memory tests and change biomarker of muscle damage and whole blood gene     expression profiles.   "
238024|NCT00972985|"     This placebo-controlled crossover study is intended to measure the effect of three, common     neuroactive medications on brain activity measured by magnetoencephalography (MEG) and     electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple     cognition testing on 15 healthy volunteers over 4 study days. Subjects will receive placebo     on one of the study days, and either 100 mg modafinil p.o., 20 mg methylphenidate p.o., or 1     mg lorazepam p.o. on remaining study days. Medication administration will be randomized     according to study day so that each subject will receive the medications in random order.     Brain activity will be measured by MEG and EEG in each subject a total of 4 times each study     day: prior to medication administration and 2, 4, and 6 hours after medication     administration. Cognition testing will be performed at pre-medication baseline and     immediately after each post-medication scan time. This study will test the hypothesis that     changes in brain functional activity can be accurately measured in healthy volunteer subjects     after single, acute doses of modafinil, methylphenidate and lorazepam.   "
238025|NCT00972998|"     This is an open label, dose-finding study. Approximately 8 healthy subjects will be     participating in this study.      A screening will be used to determine subject suitability for inclusion in the trial.     Subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one     day treatment period. During this period, 4 anal manometric studies will take place. Study     medication (Coated Phenylephrine suppositories at various doses) will be administered at     pre-determined intervals.   "
238026|NCT00973011|"     The Phase Ia, open-label, multicenter study will consist of a single-dose, dose-escalation     study of the safety, tolerability, pharmacokinetics, and immunogenicity of an intravitreal     (ITV) injection of FCFD4514S in patients with Geographic Atrophy (GA).   "
238027|NCT00973024|"     The purpose of this study is to compare the safety and effectiveness of different doses of     JNJ-42160443 with placebo in the treatment of chronic, moderate to severe low back pain     patients with a diagnosis of chronic low back pain.   "
238028|NCT00973037|"     The purpose of this study is to investigate the impact of CYP2D6 Genotype on the clinical     effects of tamoxifen using with samples from prospective randomized multicenter     study(ASTRRA).   "
238029|NCT00973050|"     The objective of this study is to compare the rate and extent of absorption of bicalutamide     50 mg tablets (test) versus Casodex® (reference) administered as 1 x 50 mg tablet under     fasting conditions.   "
238030|NCT00973063|"     The purpose of this study is to determine whether routine sterile gloving can lower     contamination rates in blood culture.   "
238031|NCT00973076|"     The primary objective is to assess the safety and tolerability of AZD8055 in Japanese     patients with advanced solid tumours.   "
238032|NCT00973089|"     The purpose of this study is to evaluate the success rate of alternative treatment of deep     carious lesions in asymptomatic primary teeth with no clinical nor radiographic signs of     pulpal inflammation. The treatment includes leaving a thin layer of caries that is present     near the pulp chamber and includes liner placement and tooth sealing. This alternative     treatment is to be compared with the treatment provided today to these teeth, which includes     complete removal of caries and probably includes pulpotomy and wide preparation of the tooth.     The study also evaluates the cost-effectiveness of both methods of treatment of deep carious     lesions.   "
238033|NCT00973102|"     Annually in the United States, approximately 30 million people require treatment for     traumatic injuries in emergency departments. Two million of these patients require     hospitalization, with several hundred thousand ultimately dying, often due to extreme blood     loss. Importantly, these traumatic injuries are the leading cause of death and disability for     children and young adults under the age of 44, with the total cost of trauma in the U.S.     approaching $260 billion each year.      Despite advances in pre-hospital care, early resuscitation, surgical interventions and     intensive care monitoring aimed at the primary traumatic injury, many survivors never     recover. A significant cause of this mortality and morbidity is thought due to potentially     preventable secondary injury, namely oxidant injury, inflammation, and apoptosis beginning in     the first few hours after the severe traumatic event.      In spite of the current bleak outlook for many of these patients, a series of animal     investigations have uncovered a promising solution to the problem of the secondary injury     seen in hemorrhagic shock and other similar processes, namely the early administration of     estrogen, a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound. Based on     these encouraging results from animal studies, the investigators hypothesize that early     administration of IV Premarin® in patients with hemorrhagic shock will safely reduce     secondary injury, and improve survival.   "
238034|NCT00973115|"     The purpose of this study is to evaluate the efficacy and safety of morning versus evening     intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with     hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL)     cholesterol percent change.   "
238037|NCT00973154|"     Background: An intact hypothalami-pituitary-adrenal (HPA) axis with an effective     intracellular anti-inflammatory activity of glucocorticoids is indispensable for host     survival during stress upon exposure to an infectious agent. Community-acquired pneumonia     (CAP) is characterized by significant mortality and increased circulating inflammatory     cytokines. Despite adequate antimicrobial therapy mortality rates for CAP have not changed     over several decades. The use of corticosteroids in patients with CAP is inconclusive.      Study aim: To compare a 7 days treatment with prednisone and placebo in patients with     community-acquired pneumonia with respect to time to clinical stability.      Study hypothesis: The investigators hypothesize that use of corticosteroids will lead to a     25% relative risk reduction for death and clinical instability.      Study type: randomized double blind intervention study      Patients: 800 patients with community-acquired pneumonia   "
238038|NCT00973167|"     Fragility fracture is common due to global aging problem, incurring huge healthcare     expenditure. The occurrence of fragility fracture is usually caused by a fall incidence of an     elderly with low bone quality and poor balancing ability. Therefore, any approach to improve     or retard both sarcopenia and osteoporosis will be helpful to prevent osteoporotic fracture     incidence. With the intensive research on low magnitude high frequency vibration (LMHFV),     many scientific evidences support the application of this biophysical modality on elderly to     maintain or improve the musculoskeletal tissues in elderly.      Many previous studies showed the osteogenic properties of vibration treatment and its     positive effects on muscular performance and blood circulation. The investigators' previous     reports also indicated that LMHFV could enhance the bone quality in spine and tibia in     elderly after one-year intervention, as well as the balancing ability with high compliance.     In animal studies, the application of LMHFV on fracture healing also demonstrated the     significant acceleration of healing by inducing callus formation and maturation, from which     upregulation of collagen I, II and BMP-2 gene expression was detected at molecular level. To     date, the long-term efficacy of LMHFV on reducing fracture risks and fracture rate is,     however, not available, which needs a systematic large-scale study to answer this important     research question.      Therefore, the hypothesis of this study is that LMHFV can maintain or enhance the performance     of various tissues of the musculoskeletal system in community elderly, thus reducing the     fracture risks and fracture rate. A large-scale prospective randomized clinical trial will be     conducted in multiple communities to investigate the long-term effect of LMHFV on fracture     rate and reduction of fracture risks in community elderly, in which multi-factorial effects,     in terms of muscle and bone, on musculoskeletal system will also be evaluated. A total of 704     elderly from 28 community centres will be recruited within 1.5-year time for a 18-month LMHFV     treatment, who will be assessed on the fracture risks at fixed time points while their     fracture rates on the third year of this study will be regarded as primary outcome for     analysis. The findings of this study will provide very useful scientific data to support the     application of LMHFV for elderly. The ultimate goal is to reduce the fracture rate and the     quality of life of community-living elderly.   "
238039|NCT00973180|"     The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx     container label design to improve patients' understanding of instructions for use.      The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy     of the enhanced Rx container label to improve patients' understanding of actual prescribed     medicines, compared to a standard label format. Patients with type II diabetes and/or     hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts     Central - NSC) receive their prescribed medicines from this location. Recruited subjects in     this study will be randomly assigned to either intervention (enhanced Rx container label) or     control (standard Rx label). All pill-form, regular dosing schedule medicines, including     diabetes and hypertensive (i.e. ACE inhibitor) medicines associated with patients' treatment     will be labeled according to study arm by the central-fill pharmacy. Study subjects will be     interviewed at the time of dispensing the prescribed medicines at the clinic, again three     months later (dispensing of refill), and finally nine months after baseline (dispensing of     refill). Pharmacy refill data and medical record information - linked at these clinics - will     be collected for exploratory analyses. Patients' ability to read and demonstrate Rx label     instructions, including auxiliary warnings, will be the primary outcomes. Other exploratory     outcome measures will also be measured, including 1) adverse effects associated with     medication use defined by a) the rate of physician visits, b) the rate of emergency room     visits, and c) the rate of hospitalizations and hospital admissions via emergency rooms for     medication side effects (e.g. hyperglycemia or hypoglycemia); and 2) health outcome as     measured by the change from baseline in hemoglobin A1c (HbA1c) and blood pressure     measurements. Data from the actual use trial will be processed, reviewed, analyzed (in order     of hypotheses), and reports prepared during the final months of this last phase of the study.   "
238040|NCT00973193|"     The purpose of this study is to investigate the activity of panitumumab in combination with     standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete     surgery and adjuvant chemotherapy.      The main hypothesis of the study is that the association of EGFR-targeting agent and     radiation therapy could be as effective or even improve the rate of pathological complete     tumoral response with fewer toxicities in comparison to the standard of care using     chemoradiation therapy.   "
238041|NCT00973206|"     The purpose of this study is to identify risks for cardiovascular events in a follow up     period of 10 years.   "
238042|NCT00973219|"     Rationale:      Worldwide, approximately 400 million people are chronically infected with hepatitis B virus     (HBV). Chronic HBV infection increases the risk of developing cirrhosis, hepatic     decompensation and hepatocellular carcinoma (HCC). The risk of developing hepatocellular     carcinoma is highest in HBeAg positive patients with high HBV DNA levels, but still the     relative risk remains 10 for HBeAg negative patients. Furthermore it has been shown that when     HBsAg is cleared before cirrhosis has developed, the prognosis is excellent. Recently the     investigators have shown that HBeAg negative patients with high HBV-DNA load and low baseline     HBsAg levels had a significantly higher HBsAg clearance (positive predictive value of 85%)     after combination therapy with peginterferon alfa2a (Peg-IFN) and adefovir.      Based on these results, a trial was designed to investigate whether combination of a     nucleos(t)ide analogue combined with PegIFN, could also provoke a high rate of HBsAg     clearance in chronic hepatitis B patients with low (HBV DNA <20,000 IU/mL) viral load.      Study design:      This is a three arm open-label prospective randomized controlled trial. 150 patients will be     enrolled into the study after assessment of eligibility. All patients must have documented     HBsAg positivity for longer than 6 months, HBeAg negativity, anti-HBe positivity, HBV DNA <     20,000 IU/mL and ALT < 5 * upper limit of normal. Patients with a Child Pugh class B or C     will be excluded. Group 1 will consist of patients treated with Peg-IFN and adefovir, group 2     will consist of patients treated with Peg-IFN and tenofovir and group 3 will consist of     untreated controls. Patients in group 1 and 2 will receive medication for the period of one     year. For enrolment into the study a liverbiopsy at time of enrolment is compulsory and is     advisable at end of treatment (week 48).      Study population: The study population will consist of 150 patients chronically infected with     hepatitis B virus with low viral load and HBeAg negativity.      Main study parameters/endpoints:      The aim of this study is to investigate what proportion of HBeAg negative, inactive carriers     of the hepatitis B virus with low (< 20,000 IU/mL) load will lose HBsAg when treated with     nucleot(s)ide analogue/Peg-IFN combination therapy.      In this study the investigators hypothesize that both treatment with peg-interferon and ADF     or Peg-IFN and TDF in HBeAg negative chronic hepatitis B patients with low HBV DNA viral load     will induce a high rate of HBsAg loss, comparable to that in patients with high viral load     after treatment with ADF and Peg-IFN.   "
238043|NCT00973232|"     The objectives of this two-part study were to compare the single-dose and multiple-dose     pharmacokinetics of extended release and immediate-release fixed combination formulations     containing tramadol-HCl/acetaminophen and to evaluate the effect of food on the     extended-release formulation.   "
238044|NCT00973245|"     This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD)     effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in     Japanese subjects with non-valvular atrial fibrillation (originally described in Japanese).   "
238045|NCT00973258|"     The aims of this proposed community-based randomized controlled trial are to evaluate the     effectiveness of nutritional, physical exercise and cognitive training interventions for     at-risk and frail elderly, to elucidate the biological determinants and changes associated     with frailty, and to develop, evaluate and demonstrate the feasibility of screening     instruments for frailty.   "
238046|NCT00973271|"     The hypothesis of this study is that DCCR is effective as both monotherapy and in combination     with a statin in lowering triglycerides in subjects with very high triglycerides   "
238048|NCT00973297|"     Falls are a major complication in patients treated in rehabilitation departments, yet studies     evaluating different interventions to reduce falls-risk are rare and inconclusive.      The aim of the present study is to evaluate the efficacy of a multidisciplinary     fall-prevention program to reduce falls and injury in stroke patients treated in a     rehabilitation department.      All stroke patients consecutively admitted to the department of rehabilitation at     Hadassah-Hebrew University Medical Center for a period of one year will be eligible for     inclusion. Upon receiving an informed consent subjects will be randomized to the intervention     group or the control (convention care) group.      There are no exclusion criteria. The Intervention includes group education on risk of falling     and safe mobility and transfers; physical therapy of balance training at the patients'     bedside twice weekly and medical assessment of medication use (anxiolytics/hypnotics,     neuroleptics, antihypertensives and other vasodilators), orthostatic hypotension, urinary     frequency/incontinence, delirium and visual problems.      Intervention therapy will not be given as an extra time, rather at the same treatment time as     the control group.      Primary outcomes are rate of falls and related injuries.   "
238049|NCT00973310|"     The purpose of this study is to determine the safety and efficacy of the concurrent use of     erlotinib and radiation therapy in the treatment of locally advanced non-small lung cancer.   "
238050|NCT00973323|"     This study was a randomized, parallel group, open label trial using warfarin as comparator.     Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups     (originally described in Japanese).   "
238051|NCT00973336|"     Primary Hyperparathyroidism (pHPT) increases bone turnover and resorption and thus calcium     efflux out of bone. After successful surgical treatment of pHPT, bone takes up calcium again     which may result in secondary hyperparathyroidism or even hungry bone syndrome. Until today     there are no studies about this problem helping to develop recommendations or guidelines how     to prevent these symptoms.      Study hypothesis: Calcium and vitamin D intake after surgery for PHPT protects the bone by     keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents     hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection).   "
238052|NCT00973349|"     This study will evaluate the safety and immunogenicity of different combinations of A/H1N1     S-OIV (swine flu) vaccine in non-elderly and elderly adults.   "
238053|NCT00973362|"     The purpose of this study is to provide data on the performance of the APTIMA HPV Assay using     the TIGRIS System in detecting HPV types that may cause cervical cancer.   "
238054|NCT00973375|"     The purpose of this study is to investigate if there is any different follow-up results by     angiography and IVUS between two different drug-eluting stents after implanted simultaneously     in same individuals.   "
238055|NCT00973388|"     The purpose of this study is to evaluate the effect of telaprevir on the results of     electrocardiograms in healthy volunteers. An electrocardiogram is an electric recording of     the heart. Telaprevir is being investigated for the treatment of chronic hepatitis C virus     infection.   "
238056|NCT00973401|"     The purpose of this study is to measure the amplitude and implicit time of electroretinogram     (ERG), darkadaptation and the calibre of retinal vessels before and after optimized medical     treatment of diabetic individuals (a lower blood glucose level) over a period of 12 months.     Newly diagnosed type 1 and type 2 diabetics as well as dysregulated type 1 and type 2     diabetic individuals will be included. Retinal vessel calibre measurements will be used as an     estimation of changes in the retinal perfusion.   "
238057|NCT00973414|"     Regional anesthesia, including epidural, spinal and combined epidural spinal anesthesia     (CSEA), is a pivotal part in modern anesthesiology. Previously, the investigators found that     epidural and spinal anesthesia during cesarean section possesses different responsiveness to     fluid (including crystalloid and colloid) management given prior or posterior to anesthesia.     Although CSEA is also widely used as an alternative of single epidural or spinal anesthesia     for its combined effect of fast onset of anesthesia of spinal anesthesia and the property of     duration of epidural catheterization, the fluid resuscitation during CSEA is still unknown.     The investigators hypothesized that fluid management during CSEA would produce different     effect on hemodynamics in cesarean section compared with epidural and spinal anesthesia.   "
238058|NCT00973427|"     The purpose of the study is to determine whether a DNA chip, designed by Medical Prognosis     Institute (MPI), can provide an accurate prognosis for survival of NSCLC (adeno-, squamous     and large cell lung cancer).   "
238059|NCT00973440|"     Older individuals account for one-third of new cancer cases and cancer-related deaths in the     United States. Older individuals are more susceptible to having a decrease in physical and     mental function following chemotherapy treatment. Geriatric assessment may provide a way to     identify those older individuals at greatest risk of functional decline before treatment     starts and during the period of treatment. Geriatric assessment includes a set of screening     questions and tests designed to determine the physical and mental status of the individual at     a point in time. Geriatric assessment also includes review of medications and other medical     conditions the individual may have that may affect function. The investigators are conducting     this study to determine if older individuals are able to complete the geriatric assessment     using a computer format and how that corresponds to their treating physician's assessment of     their functional status before and after starting a new chemotherapy treatment for colon,     rectal, breast or lung cancer. The investigators will also evaluate the usefulness of a     computerized form of geriatric assessment.   "
238060|NCT00973453|"     The aim of the study is to establish the maximum tolerated dose of PURETHAL Mites that is     achieved by 90% of the patients with less than 20% of the injections giving rise to a     swelling of > 5 cm and the optimal regimen to reach this maximum dose will be determined.   "
238061|NCT00973466|"     There has been an increase in incidence in sexually transmitted infections in HIV infected     patients in the last years. In this study the investigators will prospectively evaluate the     prevalence of symptomatic and asymptomatic infections with N. gonorrhea and Ch. trachomatis     as well as the seroprevalence of Herpes simplex Type 2 infection in HIV-infected patients     attending the clinic for infectious diseases at the Berne University Hospital. In addition,     participants will be asked to fill out a questionnaire on sexual behaviour and sexual health.      Study hypothesis: STI prevalence is high in certain risk-groups to justify screening in     regular intervals.   "
238063|NCT00973492|"     The primary objective of this trial is to assess whether functional insulinotherapy decreases     blood glucose variability at 3 months and 6 months, compared to initial values in type 1     diabetes patients.      So, this study measures the impact of functional insulinotherapy on several blood glucose     variability indicators in patients with type 1 diabetes.      This trial also has a secondary objective: to measure the effect of functional     insulinotherapy on oxidative stress and inflammation.   "
238064|NCT00973505|"     The purpose of this study is to investigate the relationship between the side     effects(especially arthralgia and arthritis) which appear in the patients who are prescribed     aromatase inhibitor(AI) and the CYP19 genetic polymorphisms.   "
238065|NCT00973518|"     The current study is intended to enrich and extend the database of Alzheimer's Disease (AD)     and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for     dementia of Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of     normal neurological function. This study will include 2 MEG and electroencephalography (EEG)     scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All     subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day     of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects     will undergo 2 standard functional tests.      This study will test the following hypotheses:        -  MEG scans of resting-state, eyes-open brain function reveal patterns of correlated          activity that differ between HC subjects and subjects diagnosed with dementia of          Alzheimer's type;        -  Patterns of correlated activity measured in AD subjects correspond to other measures of          disease severity such as standard functional test scores;        -  MEG scan patterns for HC subjects are consistent across repeated measures taken over a          30 day period.   "
238066|NCT00973531|"     The investigators would like to investigate the effects of treating sleep apnea with a     positive airway pressure device, either continuous (titrated) versus auto titrated on the     control of blood pressure in patients with Resistant Hypertension.   "
238067|NCT00973544|"     The purpose of this study is to describe the relations between closed suction drains     placement in breast reconstructions procedures with silicone prothesis to the development of     local wound complications (seroma, hematoma, infections).   "
238068|NCT00973557|"     The purpose of this research is to determine whether the drug, Bevacizumab (a monoclonal anti     VEGF-A antibody), which is approved to treat patients with metastatic colon cancer induces     hyperprolactinemia (increased prolactin secretion) in humans with intact pituitary function.     Past studies have shown Bevacizumab to shrink tumor size and also increase prolactin levels.     The mechanism of the hyperprolactinemia might be inhibition of pituitary portal vein     transport, suggesting that Bevacizumab induces prolactin secretion from normal lactotrophs in     the pituitary gland.      Patients who have been treated with Bevacizumab for at least one month will be recruited to     participate.      The subjects who are being treated with Bevacizumab by Dr. Stephen Wolin (a sub-investigator)     will be screened by him for study eligibility. Dr. Wolin will approach eligible patients with     all the information and background of the study and see if they have an interest in being     consented.      If consented, there will be 2 blood draws for the research that is not part of their standard     care in which 10 ml of blood is collected and prolactin, growth hormone, IGF-I, TSH,     thyroxine, ACTH, and cortisol will be measured. One 5ml blood draw will occur before the     administration of Bevacizumab and the second 5 ml blood draw will occur after the     administration of the Bevacizumab. The investigators will then review the laboratory results.     The blood tests are of the hormones of the pituitary gland to test pituitary function and see     if there are any abnormalities with the secretions of the gland. Pituitary function     abnormalities and hyperprolactinemia are diagnosed by looking at hormone levels in the blood     and comparing them to the normal reference ranges.      This study will only involve 10 subjects and will be conducted entirely at Cedars-Sinai     Medical Center.   "
238069|NCT00973570|"     Background: Most of the efforts to fight against young people's tobacco addiction have     focused on smoking prevention and little on smoking cessation. A smoking cessation program,     associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable     population (vocational trainees), was developed by a team of tobacco addiction specialist     physicians. We developed a study to evaluate the efficacy of the program. Its main objective     is to compare the efficacy of a smoking cessation program offered to all smokers in a     population aged 15 to 20 years in Vocational Training Centers (VTC) with that in a control     population. The objective of this paper is to present the TABADO study protocol and the     results of the pilot study.      Methods: The study is quasi-experimental, prospective, evaluative and comparative and takes     place during the 2 years of vocational training. The final population will be composed of     2000 trainees entering a VTC (in Lorraine, France): The intervention group (1000 trainees)     benefited from the TABADO program while no specific intervention took place in the control     group (1000 trainees) other than the treatment and education services usually available. Our     primary outcome will be the tobacco abstinence rate at 12 months.      The pilot study is a descriptive monocentric cross-sectional study conducted among the whole     group of students, completed by a longitudinal prospective study of smoker volunteers.   "
238070|NCT00973583|"     The investigators earlier clinical study in 754 young Finnish men demonstrated a significant     negative association of serum 25-OHD concentration with acute respiratory tract infections.     The present study aimed to determine whether vitamin D supplementation may decrease the     incidence of acute respiratory tract infections.   "
238071|NCT00973596|"     The purpose of this prospective multicenter cohort study is to examine long-term medical     outcomes, quality of life, and medical resource utilization in elderly patients (>= 65 years)     with acute venous thromboembolism (i.e., acute pulmonary embolism and/or deep vein     thrombosis)   "
238072|NCT00973609|"     Investigating the efficacy of maintenance and reinduction treatment or no treatment and     watchful waiting in subjects with inoperable or irresectable and non-progressive metastatic     colorectal cancer after first line induction treatment for 24 weeks with a fluoropyrimidine-,     oxaliplatin- and bevacizumab-based chemotherapy.      The maintenance treatment with capecitabine or 5-FU/folinic acid and bevacizumab will be     compared with a maintenance treatment with bevacizumab alone or no maintenance treatment.     Reinduction treatment will be done in case of progression.   "
238073|NCT00973622|"     This study will examine the effects of high frequency, repetitive Transcranial Magnetic     Stimulation (rTMS) on decision-making and smoking behavior.   "
238074|NCT00973635|"     A handoff is defined as the transfer of role and responsibility from one person to another in     a physical or mental process. Current evidence shows that handoffs between medical providers     are both common, and fraught with potential for harm. In spite of these problems, handoff     skills are rarely discussed or practiced. Currently, there are few curricula available in the     literature regarding the teaching of handoff skills. The purpose of the investigators' study     is to develop a curriculum focusing on key handoff safety issues. The investigators plan to     create an independent learning tutorial that would be easily administered to all beginning     interns (medical subinterns and 2nd month pgy1 medical interns), that would be accessible     across multiple sites, that would increase learner knowledge regarding key handoff safety     issues, and would improve trainee satisfaction with the handoff process. The investigators'     goal is to make this curriculum practical and time efficient. The investigators' hope is that     the educational intervention would also have a measurable impact on the quality of patient     care.   "
238075|NCT00973648|"     This pilot study aims to increase the understanding of tinnitus through the identification of     potentially altered brain networks in patients who are able to voluntarily control or alter     their tinnitus. Upon completion of this study, new knowledge will be gained about the changes     in brain activity in people who are able to modify their tinnitus.   "
238076|NCT00958906|"     The purpose of this study is to determine if intravitreal infliximab is a safe and effective     treatment for macular edema secondary to uveitis.   "
238077|NCT00958919|"     Endorphins are released in response to breathing difficulty and can modify the perception of     breathlessness. In this randomized placebo-controlled trial, resistive breathing loads are     used to provoke breathlessness in patients with chronic obstructive pulmonary disease. The     hypothesis of the study is that intravenous (IV) administration of naloxone, a medication     which blocks endorphin activity, will increase the perception of breathlessness experienced     by patients while breathing through a resistance device, compared with IV administration of     normal saline.   "
238078|NCT00958932|"     The primary aim of this project is to conduct a randomized practical clinical trial within a     large health maintenance organization to test a telephone intervention designed to improve     adherence to daily asthma medications and thereby improve asthma outcomes. The investigators     hypothesize that adherence with inhaled corticosteroid medications in the TEAM intervention     group will be greater than in the usual care group.   "
238079|NCT00958945|"     The purpose of this analysis is to compare Hemoglobin and Hematocrit levels following total     hip or knee arthroplasty. The utilization of FloSeal intraoperatively will improve hemostasis     postoperatively. Decreasing bleeding time will decrease the drop in level of Hemoglobin and     Hematocrit which usually occurs postoperatively.   "
238080|NCT00958958|"     Phase 1: An observational study (registry) will be conducted which will objectively document     the ACS clinical practice in Brazilian public hospitals, and identify the important barriers     for the evidence usage incorporation in the clinical practice.      Phase 2: A Cluster randomized clinical trial in which public hospital will be randomized to     receive or not a multifaceted strategy in order to increase evidence based therapy in     clinical practice.   "
238081|NCT00958971|"     The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 4     groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and     hormone receptor (HR) status.   "
238082|NCT00958984|"     The purpose of this study is to determine the clinical utility of non-invasive monitoring of     Hemoglobin (Hgb) and Plethysmograph Variability Index (PVI) values during the intraoperative     period of visceral solid organ transplantation in children. Hemoglobin values reflect     oxygen-carrying capacity of the blood and PVI reflects fluid balance and perfusion.   "
238083|NCT00958997|"     Pancreatic Islet beta-cells are responsible for synthesizing and secreting appropriate     amounts of insulin to regulate blood glucose levels. One factor in the development of     diabetes is the loss of beta-cells. Developing treatments to prevent or restore islet     beta-cell mass (BCM) in diabetic patients is hampered by a lack of methods for the     non-invasive imaging of these cells. This study is designed to evaluate a radiolabeled     compound that binds to the pancreatic islet. The investigators will test the ability of one     promising imaging compound, 18F-9-fluoropropyl-(+)-dihydrotetrabenazine (18F-FP-DTBZ), to     measure the amount of pancreatic islet beta-cells in patients with long-standing type-1     diabetes and in age-weight-matched healthy control subjects.   "
238084|NCT00959010|"     Essential fatty acids (EFA) deficiency has been often reported in patients with cystic     fibrosis (CF), particularly in those homozygous for the DF508 mutation. Clinical symptoms of     CF may be influenced by correcting EFA deficiency. Nevertheless, the value of EFA     supplementation in CF remains controversial. Within this multicentric and international     randomized placebo-controlled trial it will be evaluated, according to recommendations of     Cochrane analysis, beneficial effects of an oral supplementation with polyunsaturated fatty     acids on selected biochemical and functional outcome parameters such as inflammatory     biomarkers, incorporation into cell membrane phospholipids, lung function, exercise     tolerance, clinical and nutritional status and properties of transepithelial ion transport.     The study will be undertaken in a cohort of CF patients aged over 6 years old (60 patients),     homozygous for the DF508 mutation and treated by Azithromycine. Supplementation will be     performed with a triglyceride source at a daily dose of 60 mg/kg of omega-3 polyunsaturated     fatty acids (Omega 3 Premiumâ, Laboratoires Ponroy, France). Before enrolled into the trial     and during the study, patients will undergo nutritional assessment by evaluation of total and     fat dietary intake and overall calorie intake using a 3-days diet records and a food     frequency questionnaire. Plasma and erythrocyte membrane EFA profiles and inflammatory     markers will be monitored in baseline conditions, at 3, at 6 and 12 months after starting the     treatment. Lung function will be performed at each patient visit and an exercise test will be     done before and at the end of the treatment. Properties of ion transport will be searched by     sweat testing before and at the end of the treatment.   "
238085|NCT00959023|"     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify genes     related to cancer.      PURPOSE: This clinical trial is studying blood and tumor samples from men with an inherited     risk of prostate cancer.   "
238088|NCT00959062|"     Almost all critically ill children who are mechanically ventilated require sedation and     analgesia. Providing effective sedation for children in the PICU requires careful balancing     of the need for sedation with the adverse effects associated with sedative medications.     Clonidine is often used as an adjunctive sedative and analgesic in children but a well     designed and adequately powered randomized trial is required to test the effect of     clonidine-based sedation. Because there are no large randomized trials of sedation related     interventions among critically ill children there are many unknown factors. This pilot trial,     focussing on feasibility outcomes will assess the feasibility of, and inform the design of, a     larger randomized controlled trial which will focus on clinically important outcomes.   "
238089|NCT00959075|"     Background: Patients with heart failure (HF) are at increased risk of developing thiamin     deficiency (TD). Thiamin (vitamin B1) is required for the production of energy and therefore     TD may contribute to the energy depletion commonly observed in the failing heart. Thiamin     supplementation trials to date have shown conflicting results and therefore further studies     to explain the impact of thiamin supplementation on HF patients with TD is necessary.      Objective: The purpose of this study is to determine whether thiamin supplementation in an     ambulatory cohort of patients with systolic heart failure will provide any benefit in terms     of improved heart function, symptoms, exercise capacity, and quality of life.      Description: Patients involved in the study will be given either thiamin supplements or a     matching placebo (pills containing no thiamin) for 6 months. The ability of the heart to pump     before and after the supplementation will be measured using cardiac magnetic resonance     imaging (MRI)and/or 3D echocardiography.      Relevance: This study will determine whether thiamin supplementation improves cardiac     function, exercise tolerance and quality of life. Thiamin supplementation is widely     available, inexpensive, and safe. Therefore this trial may have a major impact on the optimal     management of the expanding population of heart failure patients.   "
238090|NCT00959088|"     Early identification of tuberculosis (TB) is of particular importance in HIV-infected     individuals, as a delay of therapy can be devastating in those with compromised immune     systems. Diagnosis of TB in HIV is difficult, however, because 24-61% of HIV co-infected     individuals with pulmonary TB have negative TB test results. In addition, conventional     testing can take 6 weeks or longer and may not be available at all in many settings. This     study is being conducted to see whether some new tests for identifying TB and for identifying     resistance to TB drugs are at least as accurate as the current testing methods when used on     HIV-infected individuals. The study will also assess whether the new tests can provide     accurate results faster than the current methods.   "
238091|NCT00959101|"     This trial is conducted in Asia. The aim of this clinical trial is to investigate the     bioequivalence of repaglinide and metformin combination tablet versus repaglinide and     metformin as coadministered tablets after meal.      The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic     trial where the trial participant is randomised to one of six possible treatment periods     (Williams design). The trial participant will receive one single dose of each trial product     in varying order.   "
238092|NCT00959114|"     A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.   "
238093|NCT00959127|"     This is a Phase 1 study during which patients with advanced solid tumors will receive     investigational study drug ARRY-438162 (MEK162).      This study has 3 parts. In the first part, patients with advanced solid tumors will receive     increasing doses of study drug in order to achieve the highest dose of the study drug     possible that will not cause unacceptable side effects. Approximately 30 patients from the US     will be enrolled in Part 1. (Active, not recruiting)      In the second part of the study, patients with advanced or metastatic biliary cancer will     receive the best dose of study drug determined from the first part of the study and will be     followed to see what side effects and effectiveness the study drug has, if any, in treating     the cancer. Approximately 25 patients from the US will be enrolled in Part 2. (Active, not     recruiting)      In the third part of the study, patients with metastatic colorectal cancer (CRC) will receive     the best dose of the study drug determined from the first part of the study and will be     followed to see what side effects and effectiveness the study drug has, if any, in treating     the cancer. Approximately 25 patients with KRAS mutation (Active, not recruiting) and 15     patients with BRAF mutation (Active, not recruiting) from the US will be enrolled in Part 3.   "
238094|NCT00959140|"     Stem cells collected from sibling donors for allogenic transplants contain various types of     cells. The predominant immune cells are called CD3+ T cells. The amount of these T cells vary     vastly from donor to donor. This study is to determine if standardizing the CD3+ T cell dose     will benefit the recipient (patient). As well as to help discover if dose standardization     causes less variation in outcomes between patients and to make transplantation more     predictable and complications easier to manage.   "
238095|NCT00959153|"     A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be     treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects     will be followed for 14 days. If at the 14 day follow-up visit the subject continues to     present with a stone size 4 mm or greater will have an option of retreatment or other     intervention. If the subject consents to be retreated at this time, this subject will be     followed up for another 14 days.   "
238096|NCT00959166|"     Subtle changes to the brain, which doctors find difficult to detect through conversation or     examination, may occur in patients with HIV and/or hepatitis C infection. It is not currently     known whether the brain is affected in early (or acute) hepatitis C.      This study plans to evaluate what happens to the brain in patients with HIV and early     hepatitis C. The investigators will be comparing 3 groups of individuals:        -  Group 1: Individuals with HIV infection and acute (early) hepatitis C infection        -  Group 2: Individuals with HIV infection        -  Group 3: Healthy volunteers      Individuals wishing to take part will complete a series of tests assessing different aspects     of their brain including:        -  2 brain scans using different technology:             -  Magnetic resonance imaging (MRI) brain scan with spectroscopy             -  CT PET brain scan        -  A computer game test which measures brain function        -  2 short questionnaires      Results of these tests will be analyzed and compared between 3 groups.   "
238144|NCT00959803|"     This study is designed to investigate the safety, tolerability, and pharmacokinetics of     PF-04447943 after single and multiple-dose administration to healthy young adult and elderly     Japanese subjects, respectively.   "
238097|NCT00959179|"     The purpose of this study is to evaluate the functional outcomes of resynchronization     management and to describe the patient psychosocial characteristics (depression ad anxiety)     and associated outcomes with electrophysiologic device therapy for chronic congestive heart     failure.   "
238098|NCT00959192|"     The purpose of this study is to assess the safety, tolerability, and immunogenicity of     ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in     Japan.   "
238099|NCT00959205|"     The purpose of this study is to evaluate the efficacy and safety of electroanatomic imaging     compared to conventional method in patients with VT.   "
238100|NCT00959218|"     The purpose of this study is to determine whether Dronabinol is effective and safe in     relieving central neuropathic pain in multiple sclerosis patients.   "
238101|NCT00959231|"     RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor     umbilical cord blood transplant helps stop the growth of abnormal cells. It also stops the     patient's immune system from rejecting the donor's stem cells. The donated stem cells may     replace the patient's immune cells and help destroy any remaining abnormal cells     (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving cyclosporine and mycophenolate     mofetil before and after transplant may stop this from happening.      PURPOSE: This phase II trial is studying the side effects of donor umbilical cord blood     transplant after cyclophosphamide, fludarabine phosphate, and total-body irradiation in     treating patients with hematologic disease.   "
238102|NCT00959244|"     RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at urine samples from women with newly diagnosed     breast cancer.   "
238103|NCT00959257|"     Cardiovascular disease is a major cause of morbidity and mortality worldwide. It is the     second leading cause of death in Hong Kong. The disease burden is huge and effective control     measures should target at prevention level. As the disease pathophysiology is linked to     chronic low grade systemic inflammation, any therapeutics having the potential to reduce     systemic inflammation should be vigorously explored.      The use of long-term inhaled corticosteroid (ICS) treatment in recent 2 decades has become     the cornerstone in the treatment of most patients with persistent asthma with reduction in     its mortality and hospital utilization. The long term safety of ICS in adults is generally     very high.      Recent epidemiological studies utilizing large numbers of patients with asthma have shown     that long term use of ICS is independently associated with a protective effect towards the     development of myocardial infarction and cardiovascular mortality, with protective risk at     0.35 (95%CI 0.13-0.93). This effect is possibly mediated through the reduction of low grade     systemic inflammation as reflected by plasma hs-CRP, from systemic absorption of the ICS.      The purpose of this study is to explore the potential protective effect of ICS on     cardiovascular morbidities and its underlying link with systemic inflammation in Chinese     adults with asthma compared with matched controls from the general population.   "
238104|NCT00959270|"     The purpose of this study is to develop a cohort of volunteers that can be studied and     followed up into the future for changes in health behaviors and development of health     problems.   "
238105|NCT00959283|"     RATIONALE: Studying the genes expressed in samples of blood from patients with Down syndrome     may help doctors identify biomarkers related to cancer.      PURPOSE: This research study is looking at blood samples from newborns with Down syndrome.   "
238106|NCT00959296|"     The Implantable Systems Performance Registry (ISPR) was developed to evaluate the long-term     reliability and performance of market-released Medtronic Neuromodulation infusion and     stimulation products.      Completion Notice: The ISPR was created by Medtronic to monitor the performance of     commercially available products. This registry was initially designed to track performance of     Medtronic's implantable infusion and spinal cord stimulation systems beginning in August 2003     and June 2004, respectively. Medtronic DBS Systems were added to the ISPR in June 2009, and     Sacral Neuromodulation Systems in April 2010. Medtronic retired the ISPR in April 2016 and     merged the data collected from this registry into the Product Surveillance Registry (PSR).     Please refer to that record, Clinical Trials identifier: NCT01524276, for further     information.   "
238107|NCT00959309|"     Childhood obesity is an epidemic and increasing. There are very few effective treatments for     obesity in children. Recent studies have shown an association between obesity and sedentary     behaviors such as television, video viewing and playing video games ('screen time') in     preschool aged children. A school based intervention to reduce screen time in older children     has been effective in preventing obesity.      The reduction of screen time may lead to the prevention of obesity and its complications in     preschool children.   "
238108|NCT00959322|"     The LenSx 550 laser system is a femtosecond laser intended for use in performing anterior     capsulotomy during cataract surgery. The anterior capsulotomy creates a circular opening in     the anterior surface of the capsular bag that contains the cataractous crystalline lens. The     objective of this study is to evaluate the ability of the LenSx 550 laser to successfully     perform anterior capsulotomy during cataract surgery.   "
238109|NCT00959335|"     The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50     mg tablet and Casodex following a 50 mg dose in healthy subjects under fasting conditions.   "
238110|NCT00959348|"     Inhaled steroid has been the cornerstone in the treatment of asthma, which carries a huge     patient population worldwide including Hong Kong. In general, the safety of long-term use of     inhaled steroid has been well documented. Yet, long-term users of such treatment carry     increased risk of complications like cataract. In particular, the exact association of     inhaled steroid use and development of diabetes mellitus is not known, despite a clear causal     relationship between oral steroid use and diabetes. Therefore this epidemiology study (based     on questionnaire and blood tests) aims to investigate the effect of inhaled corticosteroid on     the risk of diabetes, impaired glucose tolerance and insulin resistance in adults with     asthma. The impact of this study is expected to affect the current practice of long-term use     of inhaled corticosteroid especially among patients with asthma.   "
238111|NCT00959361|"     INTRODUCTION: Studies prove that the pharmaceutical care (PC) increases the adherence to the     antiretroviral; thus, they increase the undetectable viral load. The viral load diminishes,     and the prevalence of undetectable viral load increases, as the levels of adherence to the     treatment increase, being in general necessary high adhesion to reach the effectiveness     therapeutic. Increasing the adherence levels, it increases the surviving chances and quality     of life and diminishes the transmission risks. Studies demonstrate that the     self-effectiveness expectation to use the medication correctly is the main predictor of     adherence, and that the more complex the therapeutic regimen is, and the perception of side     effects, the smaller the adherence is, highlighting the importance of preventing, identifying     and solving the problems during the treatment with antiretroviral, problems related to the     medication (PRM) through the PC.      OBJECTIVES: To evaluate the effectiveness of the PC on the adherence of HIV-patients to the     antiretroviral therapy, identify, prevent and solve PRMs during the treatment.      METHODOLOGY: One-side randomized clinical trail controlled by non-intervention in parallel.     332 patients randomized are included in the control and intervention groups (PC).     Questionnaires will be applied: sociodemographic, adherence to the antiretroviral through     self-report, smoke, BECK (depression), CAGE (problems related with alcohol consumption) of     self-effectiveness, expectation of results and social support. Each 4 months measure of viral     load and CD4 will be carried out. The ones from the PC group will receive a card with     information about the medication and all the medicines will be identified by different     colors. The follow-up will last one year according to the instructions of DADER program.   "
238112|NCT00959374|"     The objective of this study is to evaluate the use of an absorbable barbed suture as compared     to a conventional absorbable suture when used for dermal closure during certain body     contouring procedures.   "
238113|NCT00959387|"     Over the last 30 years, induction chemotherapy (IC) has become important for the management     of patients with locally advanced HNSCC (LAHNSCC), particularly since the introduction of     taxanes. The results reported in the TAX 323 and TAX 324 trials indicate that the TPF regimen     (docetaxel, cisplatin and 5-fluorouracil) improves overall survival comparing with the PF     regimen (cisplatin and 5-fluorouracil), and the TPF regimen is globally the most accepted     induction regimen for the treatment of LAHNSCC.      However, the TPF regimen has been associated with high toxicity rates, and patients     frequently decline cisplatin during concurrent radiotherapy and require the use of infusion     pumps and a central venous catheter.      Extensive efforts are ongoing to identify alternative schemes that are less toxic than the     TPF regimen but are as effective for LAHNSCC and safely allow the use of definitive     concurrent treatment based on cisplatin and radiotherapy.   "
238114|NCT00959400|"     Eligible patients who agree to participate will migrate from oral opioids to transdermal     patches and be followed for four weeks. Oral morphine will be provided as pain rescue     medication. The patients will inform the adverse events and rescue medication consumption.     The number of Fentanest® patches will be adjusted every visit aiming to reduce the rescue     medication consumption and adverse events to a minimum. The WHO-QOL- bref (quality of life     questionary) will be filled before and after the use of Fentanest®. Patients showing benefit     are eligible to a 3 weeks compassionate study.   "
238115|NCT00959413|"     The mouth may play an important part in monitoring HIV progression. Mucosal lesions of the     mouth are often the first sign of infection and their development in already diagnosed     individuals indicates disease progression. In addition, saliva may provide a non-invasive way     to track viral load. The purpose of this study is to establish standardized practices for     examining the mouth and identifying oral mucosal lesions as well as to establish a     correlation of viral load with HIV particles found in saliva.   "
238116|NCT00959426|"     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The     primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics,     and pharmacodynamics, of multiple oral doses of PF-04620110.   "
238117|NCT00959439|"     The purpose of this study is to demonstrate the relative bioavailability of Naproxen     delayed-release tablets (375 mg).   "
238118|NCT00959452|"     Research has shown that cognitive behavioural therapy is effective in treating hypochondria.     However, no studies have examined the long term effect. The investigators have followed 56     patients treated for hypochondria between 1997 and 2001 and the investigators are now doing a     10 year follow-up (Part I). In another part of the study (Part II) the investigators compare     the effect of 16 sessions vs. 5 sessions, with a follow-up period of at least 2 years. The     investigators hypothesis is that the initial 1 year improvement will be sustained and that 5     sessions will yield the same results as 16 sessions.   "
238119|NCT00959465|"     The purpose of the study is to obtain immunogenicity and safety data at different dose levels     of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and     older.   "
238120|NCT00959478|"     Carbon Monoxide (CO) exposure kills and injures thousands of children and families each year.     Although there is growing concern about the need to increase carbon monoxide detector use,     little is known about how best to do so, especially for low-income families. The objective of     this research is to determine whether a brief intervention, Project Carbon Monoxide Detector     Education (Project CODE), will increase CO detector use. For this study, parents of children,     18 years or younger, will be randomly assigned to receive Project CODE (an educational tool     and a CO detector) or usual care (a flyer on CO poisoning); both of which will be delivered     in the Pediatric Emergency Department (PED) examination rooms. The use of a CO detector and     the participant's current stage in the theory of stage-based behavior change—the Precaution     Adoption Process Model (PAPM), will be assessed at enrollment and then again at the home     visits which will occur two-weeks and six-months following the PED visit. The investigators     hypothesize that parents receiving Project CODE will have working CO detectors and will be     further along in the PAPM than parents in the control group at the two-week and six-month     home visits. The long term goal of this research is to reduce the number of injuries and     deaths from CO poisoning.   "
238121|NCT00959491|"     The purpose of the investigators study is to evaluate the diagnostic ability of a new     immunological fecal occult blood test in Cuban patients undergoing colonoscopy .   "
238145|NCT00959816|"     The objective of this study is to determine the amount of ABT-614 in the cerebral spinal     fluid and blood after administration of a single dose and after administration of daily doses     for 14 days in healthy volunteers.   "
238122|NCT00959504|"     As an external validation test of the performance of the VeraCode Genotyping Test for Factor     V and Factor II on the BeadXpress System, clinical trials will be conducted at three sites.     This study will assess genotyping accuracy as compared to bidirectional sequencing and     genotyping reproducibility across variables such as user, day, and site.   "
238123|NCT00959517|"     This study is an evaluation of the benefit of adding artesunate to existing first and second     line antimalarial therapies in Pakistan.      A placebo controlled trial was carried out to assess two potential benefits of Artesunate     Combination Therapy (ACT): efficacy and potential for transmission reduction.   "
238124|NCT00959530|"     The purpose of this study is to find the difference between patient satisfaction, masticatory     performance and cost between two occlusal schemes for complete denture prosthodontics.   "
238125|NCT00959543|"     MRI examination of 60 shoulders of waterpolo players (30 throwing shoulders as well as the     opposite side) and 15 healthy probands as control group (30 shoulders of non waterpolo     players. The correlation of MRI alteration and clinical symptomatic findings in both groups     will be investigated. The clinical examination is performed by 2 board certified orthopedic     surgeons and based on the Constant Murley Score.   "
238126|NCT00959556|"     RATIONALE: Studying the genes expressed in samples of blood from patients with cancer may     help doctors identify biomarkers related to cancer. It may also help doctors predict how     patients will respond to chemotherapy.      PURPOSE: This clinical trial is studying blood samples in patients with breast cancer.   "
238127|NCT00959569|"     This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients     undergoing cardiac surgery to study the additive cardiac protection of this therapeutic     strategy.   "
238128|NCT00959582|"     This study will characterize FDG-PET (18F-Fluorodeoxyglucose-Positron Emission Tomography) as     an early response marker in recurrent, platinum-sensitive ovarian cancer treated with     platinum-based therapy.   "
238129|NCT00959595|"     Sensory input from the foot as well as all other body parts results in activation of sensory     cortex.      It is well known that the cortical body map is experienced-dependant and can rapidly change     in response to changes in activity and sensory input from the periphery [10-12]. Increased     activity and sensory input from the hand results in expansion of the cortical hand     representation [13-15], while decreased sensory input, for instance by anaesthesia,     amputation or nerve injury, results in shrinkage of the cortical hand representation [16-21].     Due to the constant ongoing cortical competition between body parts the adjacent cortical     areas expand and take over the silent area, deprived of sensory input.      The investigators have recently described striking examples of such rapid cortical     re-organisations induced by selective cutaneous anaesthesia of the forearm: application of     EMLA cream to the volar aspect of the forearm results in improved sensory functions of the     hand [18] linked to expansion of the hand representational area in sensory cortex . In     analogy, EMLA application to the lower leg in healthy controls results in improved sensory     functions in the sole of the foot linked to expansion of the foot representational area in     sensory cortex.      To test the hypothesis that EMLA application to the lower leg of diabetic patients will     result in improved sensory functions in the sole of the foot as well as expansion of the foot     representation in sensory cortex. The investigators hypothesize that repeated applications of     EMLA will result in a long lasting sensibility improvement.   "
238130|NCT00959608|"     Think Health! A Personal Weight Management Program, or ¡Vive Saludable! Un programa     personalizado de control de peso aims to improve the treatment of obesity in adults in the     general population, by conducting research with men and women recruited from primary care     medical practices. The study has a particular focus on African Americans and Latino. The     design is randomized trial of the effectiveness of two versions of a lifestyle weight loss     program called delivered by primary care providers (PCP) and ancillary staff at 5 clinical     practice sites to their own patients. The two versions of the lifestyle weight loss program     are called Basic (minimal counseling provided by PCP every four months) and Basic Plus (same     PCP counseling plus additional counseling by specially trained ancillary practice staff     acting as Lifestyle Coaches (LC), monthly for the first 12 months and then every other month     for up to 2 years).   "
238131|NCT00959621|"     1 % of all pregnancies end in habitual/recurrent abortion. In about half of women with     habitual abortions (HAB) hereditary or acquired (antiphospholipid antibodies) thrombophilia     are observed. The investigators wanted to test whether antithrombotic treatment     (Low-Molecular Weight Heparin, LMWH, ASA or both combined)would prevent these women from a     subsequent abortion. Depending on thrombophilic status the women included in one of the three     sub-studies: HABENOX 1 (mild, single thrombophilia), HABENOX 2 (no known thrombophilia),     HABENOX 3 (moderate to severe thrombophilia, with combined thrombophilia or moderate to high     titer antiphospholipid antibodies).      Study design: Randomised placebo controlled multicenter study.      Number of patients per study: 90 patients per group, 270 altogether.      Timetable: Starting 2/2002, finishing 31.12.2007.      Time frame: >37 weeks of gestation and >24, but <37 weeks of gestation (premature)      Treatment started before 7. gw.      HABENOX 1 and 2:      Study groups:      Group 1 : Enoxaparin 40 mg+ placebo, Group 2: Enoxaparin 40 +ASA 100 mg, Group 3: ASA.      HABENOX 3:      Study groups:      Group 1: Enoxaparin 40 twice daily+ placebo o.d., Group 2: Enoxaparin 40 mg twice daily +ASA     100 mg o.d.      Primary end-points:      Pregnancy outcome: livebirths ( ≥37 weeks of gestation), premature livebirths (≥24, but <37     weeks of gestation)      Secondary end-points: Bleeding complications, intrauterine growth retardation (<-2SD),     pre-eclampsia, abruptio placentae,      Ending: In the group of combined medication, tablets will be stopped at 36 weeks of     gesta-tion. LMWH will be started in all patients after delivery and continued 6 weeks     postpartum.   "
238132|NCT00959634|"     This is a study to investigate the process by which ABT-126 is absorbed, distributed,     metabolized and eliminated by the body of a healthy volunteer.   "
238133|NCT00959647|"     This was a multicenter, open-label extension study. Patients who received vismodegib     (GDC-0449) in a Genentech-sponsored study and who had completed the parent study or who     continued to receive vismodegib at the time the parent study closed were eligible for     continued treatment in this protocol.   "
238157|NCT00959972|"     The purpose of this study is to determine if a new drug, varenicline, for smoking cessation     is more effective than the standard nicotine replacement therapy aide currently used, the     patch among smokers hospitalized with coronary heart disease.   "
238134|NCT00959660|"     The purpose of this study is to examine the effects of weight loss via hypocaloric diet,     aerobic exercise training, combined hypocaloric diet and exercise training, and attention     control in patients with heart failure and a normal ejection fraction (HFNEF) and body mass     index greater than or equal to 30.   "
238135|NCT00959686|"     A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell     lymphoma BENTLY.   "
238136|NCT00959699|"     The primary objective of this trial is to compare the efficacy of boceprevir (SCH 503034) 800     mg three times a day (TID) orally (PO) in combination with peginterferon alfa-2b (PegIFN-2b)     1.5 µg/kg weekly (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (RBV)     (600 mg/day to 1400 mg/day) PO to therapy with PegIFN-2b + RBV alone in adult participants     coinfected with human immunodeficiency virus (HIV) and previously untreated chronic hepatitis     C virus (HCV) genotype 1.      Boceprevir is a potent, orally administered, novel serine protease inhibitor, specifically     designed to inhibit the HCV nonstructural protein 3 (NS3) protease and, thereby, inhibit     viral replication in HCV-infected host cells. The mechanism of inhibition represents a new     mechanism of action compared to both interferon alfa and ribavirin. Based on previous     experience with PegIFN-2b and RBV in combination with boceprevir in the HCV-monoinfected     population, this combination treatment is expected to provide significant benefit to the     HIV/HCV coinfected population. Given the high unmet medical need of these participants and     the benefit of the addition of boceprevir to PegIFN-2b/RBV, it is important to demonstrate     the safety and efficacy of boceprevir in combination with PegIFN-2b/RBV in participants     coinfected with HIV/HCV.      This is a randomized, multi-center trial, double-blinded for boceprevir or placebo in     combination with open-label PegIFN-2b/RBV in participants coinfected with HIV and previously     untreated chronic HCV (genotype 1), to be conducted in conformance with Good Clinical     Practice (GCP). This trial consists of two arms, one control arm (Arm 1) and one experimental     arm (Arm 2). Participants in the control arm (Arm 1) may receive boceprevir/PegIFN-2b/RBV via     a crossover arm.   "
238137|NCT00959712|"     This proposal is a randomized control trial using innovative interactive health technologies     to promote and sustain walking behavior among elderly patients. The technology uses an     Embodied Conversational Agent (ECA), a computer character that simulates face-to-face     conversation. The trial will be block randomized by literacy status and include an intensive     two-month, daily contact intervention via a Tablet PC ECA in the subject's home, an automated     telephone program, and then an in-clinic, kiosk-based ECA for an additional 10 months, to     promote maintenance of walking behavior. The study will occur in 2 phases, a pilot phase in     which 20 subjects will be enrolled for the purpose of pre- testing the intervention and all     data collection instruments, and a main study phase in which an additional 264 subjects will     be enrolled.   "
238138|NCT00959725|"     The purpose of this study is to determine if intravitreal infliximab is a safe and effective     treatment for macular edema secondary to diabetes.   "
238139|NCT00959738|"     Diverting ileostomies are created to protect a rectal anastomosis or in situations with a     risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the     loop is an established technique to perform a diverting loop ileostomy. However, various     rod-less techniques have been described and are performed with similar success. The aim of     this study is to determine, whether a modification (without rod) of the current standard     method of protective loop ileostomy formation (with rod) could improve ileostomy specific     morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma     function.   "
238140|NCT00959751|"     This is a a multi-center, randomized, double-blind, parallel group, and placebo controlled,     two-arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache     without aura. Up to 120 migraineurs will be enrolled. Approximately 60 subjects having a     headache history of migraine without aura will complete each of the two treatment arms to     evaluate NXN-188 600 mg or placebo.   "
238141|NCT00959764|"     The purpose of this study is to compare the effectiveness and tolerability of two     medications, calcitonin nasal spray and a tablet containing calcitonin, in postmenopausal     women with osteoporosis. Osteoporosis is the term used to describe a large group of diseases,     which are characterized by loss of bone density, which makes the bones weaker. Osteoporosis     often occurs in postmenopausal women.      Calcitonin is a hormone found in the human body. Together with other substances, it regulates     the concentration of calcium in the blood and inhibits the natural resorption of bone. Both     medications in this study contain salmon calcitonin (sCT), because this form of calcitonin is     more active than human calcitonin when used as a medicine.      The calcitonin Nasal Spray used in this study is registered and available to doctors in     United States for the treatment of osteoporosis. The medication being tested in this study is     an oral tablet form of salmon calcitonin.   "
238142|NCT00959777|"     The safety, tolerability, and pharmacokinetics(PK)/pharmacodynamics (PD) of DA-3031     (PEG-G-CSF) following a single dose delivered by subcutaneous (SC) injection were     investigated in healthy volunteers. PK/PD of filgrastim (Dong-A) following repeated dose     delivered by SC injection were investigated in healthy volunteers. PK/PD from a single dose     of DA-3031 and repeated dose of filgrastim (Dong-A) were compared.   "
238143|NCT00959790|"     Rationale: Consumption of vegetables is generally considered to be associated with several     positive effects on health. Vegetables are a heterogeneous group of our diet which is rich in     bio-actives. The vegetables contain a range of vitamins, minerals, dietary fibres and     phytochemicals like potassium, flavonoids, carotenoids, and vitamin C. The recommended intake     of vegetables by the Dutch Health Council is 200 grams daily (Health Council, 2006).      Health in this project is defined as the possibility of a subject to change and adapt easily     in response to a certain challenge. Healthy subjects show resilience in different     physiological processes related to oxidative stress, metabolic stress, neurological stress     and inflammatory stress. The reaction/response to a challenge might be changed when subjects     have consumed more or less vegetables and have an improved health status. The response might     also differentiate between subjects differing in BMI (healthy weight versus     overweight/obese). Supplementation of vegetables will be provided in two conditions: a low     and a high daily intake (50 versus 200 grams daily). An intervention known to have positive     effects on health is weight loss. This will be studied in relation to health (the reaction to     the challenge test) as well.      A beneficial effect is present when 5% improvement of health markers is shown with vegetable     supplementation, similar as is known from weight loss studies.      Objective: The primary objective of the present study is to set-up a methodology to     investigate health based on the resilience to challenge. A secondary objective is the     effectiveness of the challenge concept with a food intervention. The vegetable     supplementation study is a first example to test the challenge concept. Therefore, vegetable     consumption according to the recommendations of the Dutch Health Council of 200 grams of     vegetables daily will be studied with an exercise challenge test, to investigate the     beneficial 'health' effects.   "
238169|NCT00960141|"     A study of the ability of montelukast to improve signs and symptoms of seasonal allergic     rhinitis compared with placebo. Loratadine is included in the study as an active control.   "
238146|NCT00959829|"     Objectives: (1) To check music and voice message influence on vital signs and facial     expressions of patients in physiological or induced comas; (2) To connect the existence of     patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale.      Method: This was a randomized controlled clinical trial with 30 patients, from two Intensive     Care Units, being divided in 2 groups (control and experimental). Their relatives recorded a     voice message and chose a song according to the patient's preference. The patients were     submitted to 3 sessions for 3 consecutive days.   "
238147|NCT00959842|"     This study will build upon a previous finding that showed a triglyceride lowering effect of     prescription omega-3 in combined therapy with statins. The proposed study will use a simple     change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin     therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 -     screening (blood draw for qualification and safety); day 7 - before taking prescription     omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking     prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study     will include up to 15 subjects and will utilize several different measures of lipoprotein     structure and function. The investigators will measure functional parameters such as the     binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The     investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma,     very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density     lipoprotein (HDL).   "
238148|NCT00959855|"     This study has been designed to capture a large group of patients who undergo pulmonary     rehabilitation and map their progression over a 5 year time-frame.      The outcome measures have been chosen to capture physiological, functional capacity,     free-living activities plus admission and exacerbation rates thereby enhancing our     understanding of the potential effects exercise and self management techniques may have on     the disease progression.      Pulmonary rehabilitation has not been shown to reduce inflammation; therefore, unlike acute     exacerbation's where a decrease in inflammation indicates recovery, the exact mechanisms     responsible for improvement during pulmonary rehabilitation are as yet unknown.   "
238149|NCT00959868|"     This is a single centre, open label, phase I dose escalation trial using a modified     accelerated titration design. Patients with superficial bladder tumour (Ta or T1) or CIS and     candidates for transurethral resection or muscle invasive disease (>T2) and candidates for     radical cystectomy will be enrolled.      OGX-427 will be given neoadjuvantly over 8 days, followed by a transurethral resection (for     superficial disease) or radical cystectomy (for muscle invasive disease).      Baseline Hsp27 levels will be determined from pre-treatment cytological samples from bladder     washings and tumour biopsies performed prior to therapy.      Post-treatment PK and PD data will be determined from TUR (for Ta, T1 tumours) or radical     cystectomy (for T2 tumours) specimens. A recommended phase II dose will be determined from     the toxicity, tissue pK, and percentage of Hsp27 knockdown. Effects of treatment on Hsp27     client protein levels and apoptotic index will also be evaluated.      Evaluation during protocol treatment will take place to assess toxicity. Assessments will     occur on various visits as per Evaluation Schedule. Adverse event evaluation based on NCI     CTCAEv3.0. For quality of life assessment during treatment, the EORTC QLC-BLS24 will be used     before first treatment (day 1) and prior to surgery (TURBT or radical cystectomy). The Day 1     QOL assessment will serve as baseline.      After removal from protocol treatment, all subjects will be followed for toxicity related to     study drug for 30 days.      After the study, subjects will be followed according to standard of care. Follow-up for     tumour recurrence or superficial tumours will be assessed every three months by cystoscopic     examination for two years, then every six months for the next two years, and then yearly     thereafter.   "
238150|NCT00959881|"     This study examines the cardiac effects (effects on the heart) of administering donepezil and     begacestat together to healthy subjects.   "
238151|NCT00959894|"     The main study is a single arm, open-label, prospective study to assess antiretroviral     activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose     tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a     genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of     the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in     genital secretions when subjects are taking etravirine. The purpose of the metabolic     sub-study is to learn about the effects of etravirine on body composition, as well as lipid     and glucose levels.   "
238152|NCT00959907|"     The objective of this study is to compare the action halos of the botulinum toxins (Dysport®     and Botox®) using two equivalence-ratios and to gather supportive information, such as more     detailed data on the effectiveness in reduction of wrinkles and duration of action on the     upper part of the face of both products, trough scales and photographs evaluations.   "
238153|NCT00959920|"     The goal of this study is to compare two clinically-relevant bladder drainage techniques.     This is a randomized controlled trial with a single primary outcome of time to delivery. The     results will inform clinical decisions about method of catheterization during labor.   "
238154|NCT00959933|"     The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200     capsules and Rebetol 200 mg capsules in females under non-fasting conditions.   "
238155|NCT00959946|"     This is a research study in 2 parts assessing the following parameters of the combination of     the study drug called bosutinib, and a drug called capecitabine: the safety, how well the     subject's body handles the study drug, and preliminary anti-tumor activity as treatment for     different types of cancers in part 1, and breast cancer only in part 2.      In part 1, subjects will receive bosutinib and capecitabine daily at different dose levels of     each drug in order to determine the highest tolerated dose of the combination study     treatment. In part 2, subjects will receive bosutinib and capecitabine at this highest     tolerated dose to see how well the study treatment works to treat breast cancer. In addition,     genetic research testing (research analyses involving genes and gene products) will be     performed on biological samples from subjects.   "
238156|NCT00959959|"     The purpose of this study is to determine whether TOK-001 is safe and shows biological effect     in the treatment of castration resistant prostate cancer (CRPC).   "
240329|NCT01002274|"     This is an open-label extension study of another study protocol, MCS-2-TWN-a. Subjects who     have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be     eligible for this study.   "
238158|NCT00959985|"     Women who have been treated for breast cancer may be at risk for lymphedema or arm swelling.     Currently, there are no clear treatment guidelines for lymphedema. One treatment method used     to treat lymphedema is the use of compression sleeves to encourage the flow of lymph fluid     out of the arms and prevent arm swelling in the future. Another treatment method is more     intensive and involves wearing compression sleeves as well as special compression bandages     overnight. It is unclear whether the use of compression with both sleeves and bandaging is     more effective in treating lymphedema than the use of compression sleeves alone. The purpose     of this research study is to evaluate the effectiveness of the use of compression garments in     preventing or slowing the progression of lymphedema in breast cancer patients.   "
238159|NCT00959998|"     Persistent cancer related fatigue (PCRF) is a common symptom experienced by many cancer     survivors, which may last for as long as 10 years following treatment. PCRF is currently     under diagnosed, with between 20% to >60% of survivors experiencing this symptom. Currently     there are few effective treatment options for these patients. Acupressure offers a potential     low-toxicity self-administered treatment option to treat PCRF.      The investigators performed a pilot randomized single-blinded controlled trial of acupressure     in cancer survivors experiencing moderate to severe PCRF. Potential participants were     excluded if they had other causes of fatigue such as anemia, malnutrition, or chronic fatigue     syndrome. Participants were randomized to one of three treatment groups: 1. relaxation     acupressure (RA), 2. high intensity stimulatory acupressure (HIS), and 3. low intensity     stimulatory acupressure (LIS). Participants performed acupressure for 12 weeks between 3 to     14 times per week depending on group. Fatigue was measured with the Brief Fatigue Inventory     (BFI). Secondary outcomes included beliefs and expectations, assessment of blinding,     compliance to treatment, demographics, and clinical parameters. The effect of group on BFI     was assessed with ANOVA and linear regression. Correlations were also made between compliance     and change in BFI.   "
238160|NCT00960011|"     Tension-less mesh repair is the most common procedure for inguinal hernia. Conventional heavy     weight polypropylene meshes have been reported to stimulate inflammatory reaction and this is     responsible for mesh shrinkage and postoperative chronic groin pain. Moreover, the fixation     of the mesh with sutures is a tedious procedure and accounts for the majority of the     operating time. A self gripping semi-absorbable mesh has been developed for anterior tension     free inguinal hernia repair. It has the benefit of light weight property and does not require     sutures for fixation. This study aims to compare the outcome of this self-gripping light     weight mesh with the conventional heavy weight polypropylene mesh in inguinal hernia repair.   "
238161|NCT00960024|"     This project aims at generating evidence of a work-rehabilitation strategy that benefits the     people with severe mental illness (SMI) who want to work, increase their sense of well-being     and integration in society, decrease their financial dependence and experiences of stigma and     discrimination. The project is likely to help form the basis of how to implement the evidence     based supported employment (SE)-model, Individual Placement and Support model (IPS), in a     Swedish work-rehabilitation context. In the long run, evidence of SE in a Swedish context     could help to decrease the period of sick-leave and increase fulfilling and productive     lifestyles among people with severe mental illness. In all, the effectiveness of SE can     improve the quality of life for the target group, the quality in mental health care     rehabilitation and decrease the costs of treatment and care.   "
238162|NCT00960037|"     This study is an extension of an earlier study of vitamin D supplementation conducted on     normal weight individuals by Dr. John Aloia of the Bone Mineral Research Division at Winthrop     University Hospital. The investigators plan to compare the response to vitamin D     supplementation in obese individuals with the response already measured in normal weight     individuals. The same dosing schedule of vitamin supplementation will be used as in the past.     The doses used in the past have demonstrated safety in a number of trials, here at Winthrop     as well as outside of Winthrop Hospital. Sixty study volunteers are planned for enrollment in     the study. The study participants will mainly be recruited from a group of patients who have     in the past been enrolled in the weight loss program at Winthrop Hospital. Each participant     will be on vitamin D supplementation for a total of 8 weeks. Vitamin D blood levels will be     measured before and at the end of the supplementation period. They will then be compared to     see the change over time as a result of supplementation.   "
238163|NCT00960063|"     This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of robatumumab (SCH     717454, MK-7454) administered in combination with chemotherapy in pediatric participants with     solid tumors, to be conducted in conformance with Good Clinical Practices. This study will     evaluate the safety, tolerability and dose-finding of robatumumab when administered in     combination with temozolomide and irinotecan (Arm A); or cyclophosphamide, doxorubicin, and     vincristine (Arm B), or ifosfamide and etoposide (Arm C).      The primary study hypothesis is that robatumumab can be safely administered in combination     with chemotherapy regimens in pediatric participants with solid tumors.   "
238164|NCT00960076|"     The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and     Metformin XR vs. uptitrated Metformin XR.   "
238165|NCT00960089|"     There is a major clinical need for an inexpensive topically-applied product that can inhibit     the growth of the dermatophytes that cause nail fungus. Chesson Labs has developed LIQUICURE     with a longer drying/curing time that will allow better nail penetration or adsorption.     Though the product may have inherent antimicrobial activity, the product does not contain a     drug or antimicrobial agent.      Consistent use of LIQUICURE as described will clear fungal nail infection. Clearing of nail     fungal infection is defined by negative dermatophyte culture and visual improvement in nail     characteristics within six months, with few, if any product-related adverse events.   "
238166|NCT00960102|"     The purpose of this study is to evaluate short and long term outcomes (benefits and     side-effects) of bilateral cochlear implantation in Finnish children.   "
238167|NCT00960115|"     This is a phase I/II study in Japan to evaluate the safety of EMD531444 and its effects on     survival time in patients with stage III unresectable non-small cell lung cancer.   "
238168|NCT00960128|"     This observational study is conducted globally. The aim of the study is to investigate the     effectiveness and safety of real-life treatment with Norditropin®. The study population will     consist of children and adults who are on treatment with Norditropin® in accordance with     normal clinical practice.   "
238170|NCT00960154|"     The purpose of this clinical study is to quantify the difference in thermal injury depth at     the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to     subjectively assess histopathologic sample quality metrics; to examine the role that     electrosurgical artifact may play in revision lumpectomy procedures; and to compare these     endpoints to the standard of care (SOC) technology.   "
238171|NCT00960167|"     Hepatocellular carcinoma (HCC) is one of the leading malignancies in Taiwan. Surgery and     local ablative therapy remain the treatment of choice for curative purpose. Transarterial     chemoembolization has been the mainstay of intrahepatic control for patients not being     candidates for local modalities of treatment. Sorafenib is recently integrated into the     treatment options, mainly for intrahepatic or extrahepatic wide spread disease     contraindicated for the other modalities. External radiotherapy (RT) has been selectively     used for patients with the localized hepatic tumor(s) refractory to the above treatment     options. The data from the retrospective studies were biased by the patient selection and     uncontrolled comparison with patients not receiving RT. The obstacles for RT to HCC remain     unanswered with heterogeneity in dose of radiation and lower tolerance of liver to RT in     viral hepatitis carriers. Such a sublethal dose might be associated with unsatisfactory tumor     control, intra-/extra-hepatic metastasis, and radiation-induced liver disease in a     significant proportion of HCC patients.      The purposes of this phase I study are primarily to determine the maximally tolerated dose of     RT, and secondarily to evaluate the tumor control, to assess patterns of failure and     survival, to analyze the characteristics of radiation-induced liver disease, as well as to     collect blood samples for translational research. HCC patients who are hepatitis B virus     carriers and graded as Child-Pugh A cirrhosis are enrolled. This dose escalation trial is     conducted with the 7-Gy increase in 2 fractions (3.5 Gy per fraction) for a total of four     levels, from 42 Gy up to 63 Gy. Conformal RT with three-dimensional design, intensity     modulated RT, or volumetric modulated arc therapy is used with the defined dose-volume     threshold for normal liver and the other structures. Five patients are treated for each dose     level, with dose limiting toxicity in less than 2 patients judged to be acceptable. A minimum     of 15 patients are required for the starting dose level of 49 Gy if the treated tumor     diameter is less than 10 cm. Imaging modalities are used for estimating treatment response     and detecting metastasis. Serum analyses are done for evaluating hepatic function, viral     load, hematological toxicity, and translational research for angiogenic and inflammatory     studies.   "
238172|NCT00960180|"     This is a first-in-human study of MR1817. This study will provide an initial assessment of     the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after     administration of ascending single oral doses to healthy adult subjects.   "
238173|NCT00960193|"     Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one     of the enzymes responsible for the metabolism of colchicine. This study will evaluate the     effect of multiple daily consumptions of Seville orange juice on the pharmacokinetic profile     of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and     tolerability of this regimen in healthy volunteers. All study subjects will be monitored for     adverse events throughout the study period.   "
238174|NCT00960206|"     The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to     demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with     the appropriate shell in a cementless application.   "
238175|NCT00965653|"     This open-label randomized 2arm study will investigate the pharmacokinetics,     pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients     with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients     will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in     combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals     during treatment and on the 3 weeks of follow-up.Target sample size is < 50 individuals.   "
238176|NCT00965666|"     The purpose of this research study is to evaluate the safety of the drug Etanercept (Enbrel)     and to determine if this drug can help in the treatment of early bone marrow failure in     patients with Fanconi anemia.   "
238177|NCT00965679|"     Background:        -  Computed tomography (CT) creates three-dimensional images based on X-ray imaging. CT is          useful for determining treatment approaches for certain diseases, such as calcific          aortic stenosis (narrowing of the aorta because of calcium deposits).        -  Comparing the data received from CT scans with the data received from heart          catheterization (which assesses the heart's condition and function) can be used to          improve treatment in patients with certain heart conditions. Researchers are interested          in looking at the effectiveness of both procedures in assessing possible surgical          treatments for patients with calcific aortic stenosis.      Objectives:      - To analyze cardiac CT scans in conjunction with existing heart scan results to improve     treatments for future minimally invasive aortic valve replacement.      Eligibility:      - Patients 18 years of age and older who have been diagnosed with aortic valve stenosis that     may be treated surgically, and who will undergo or have recently undergone heart     catheterization.      Design:        -  Participants will have a CT scan within 90 days of the medically necessary heart          catheterization, but before any other surgical or catheter treatment.        -  During the CT scan, patients will be asked to hold their breath intermittently for about          5 to 20 seconds. Patients will be inside the scanner for less than 30 minutes.        -  Patients will be asked to return in 3 to 7 days for a blood test to check kidney          function.        -  Researchers will analyze the results of the CT scan in conjunction with the previous          results from the catheterization to determine possible improved treatment options.   "
238178|NCT00965705|"     Temple University is looking for women to participate in a study to evaluate the treatment     options available to women living with binge eating disorder.      Binge-Eating Disorder is a significant public health problem for women. Despite this, there     is limited research on how best to treat this disorder at varying levels of severity. The     purpose of this NIMH-funded study is to enroll individuals in a brief form of     cognitive-behavior therapy. If more intense treatment is needed, individuals will be randomly     assigned to more intensive group and individual treatments (Cognitive-Behavior Therapy or     Dialectical Behavior Therapy). Both of these treatments are talking therapies that have been     adapted for women living with binge-eating disorder and are free of charge.   "
238179|NCT00965718|"     Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte     (Immuncell-LC) cell therapy in Gemcitabine refractory advanced pancreatic cancer   "
238180|NCT00965731|"     This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone     versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell     lung cancer.   "
238181|NCT00965744|"     The aim of this trial was to verify the efficiency of a new surgical device (the LigaSure     vessels sealing system) in esophagogastric decongestion and splenectomy in patients with     portal hypertension.   "
238182|NCT00965757|"     The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when     added to ongoing, stable-dose methotrexate therapy in patients with persistently active     rheumatoid arthritis   "
238183|NCT00965770|"     It has been shown that the immediate insertion of intrauterine devices (IUDs) post-abortion     prevents repeat abortions. The researchers hypothesize that providing free IUDs post-abortion     will be associated with a lower rate of repeat abortion in a Canadian population. Further,     the researchers hypothesize that providing free IUDs post-abortion will be associated with     decreased costs for the health care system.   "
238184|NCT00965783|"     To test whether baseline levels of slow wave activity (SWA) during sleep are lower in obese     adults, and even lower in persons with sleep disordered breathing (SDB) compared to lean     adults.      To compare levels of SWA in individuals in relation to their sleep time, blood pressure,     heart rate, and markers of glucose metabolism.   "
238185|NCT00965796|"     The objective of the present study was to evaluate the effect of intraoperative intravenous     lidocaine on postoperative pain after hysterectomy.   "
238186|NCT00965809|"     Stress Disorder (PTSD) is a chronic and debilitating anxiety disorder which is widespread in     every social level and is very prevalent in outpatient and inpatient settings.      A recent open-label study showed that the synthetic cannabinoid receptor agonist Nabilone had     beneficial effects abolishing or greatly reducing nightmares that persisted in spite of     treatment with conventional PTSD medications. Furthermore, a big number of patients suffering     from chronic PTSD report using smoked marijuana because its tranquilizing effect and sleep     quality improvement. According to clinical and epidemiological data different derivates from     the cannabis plant are illegally and pervasively consumed by PTSD patients in order to reduce     distress.      The aim of the proposed study is to broaden the previous observations and to measure the     extent to which Δ 9-THC will bring to significant improvement on the full spectrum of PTSD     symptoms.   "
238187|NCT00965822|"     Parents with children aged 3-11 will participate in this study. About 500 children will take     part in the study. We expect about half of those children will develop symptoms of a     respiratory infection. Active participation in this study will last 14 days after a parent     reports symptoms of a respiratory infection in a participant. Those children who do meet the     study criteria of symptoms will then be randomly placed (like a flip of a coin) into one of 2     groups to take either COLD-FX® or placebo for 3 days. A placebo will look exactly like     COLD-FX® but contains no active ingredients. The participant has an equal chance of being     placed in either of the above groups. The study is double-blind, so neither the participant     nor the study staff will know which study group the participant was placed in until the study     is completed. If this information is needed in an emergency at any time throughout the study,     it is quickly available from the sponsor.      Participation in the study will be for 14 days after symptoms of a respiratory infection are     reported to study staff. Your child will take the study product for 3 days, you will complete     a daily diary, receive 4 phone calls and be seen for a final study visit to review the diary     and complete a final health check of your child.   "
238188|NCT00965835|"     The purpose of this study is to develop small molecule radio-labeled probes of beta-amyloid,     to be used with positron emission tomography (PET) for early detection and treatment     monitoring of Alzheimer disease (AD). The study hypothesis is that PET imaging of small     molecule probes, in the form of novel fluorescent dyes with radioactive labels, will     demonstrate cerebral patterns in patients with AD that are distinct from those of age-matched     persons who are cognitively intact.   "
238189|NCT00965848|"     The purpose of this study is to assess the safety and efficacy of doripenem in participants     with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy;     pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal     (in belly) infections and complicated urinary tract infections (bladder infections).   "
238190|NCT00965861|"     Sarah Cannon Research Institute (SCRI) is committed to improvement and excellence in clinical     research and correlative science. To this end, the SCRI Oncology Research Consortium will     collect written consent from patients allowing the use of their tumor tissue sample(s) for     testing/analysis at a future date. Future testing may include assays for newly identified     markers of potential prognostic and/or therapeutic value. These markers may be specific to an     individual cancer type, or they may be present more generally in cancer and/or other     conditions.   "
238191|NCT00973661|"     The purpose of this study is to design and assess the impact of an electronic alert and tool     set to assist with physician identification and counseling of overweight patients.   "
238192|NCT00973674|"     Each year in the United States alone, a third of a million persons are hospitalized for     traumatic brain injury (TBI), of whom approximately 1/4 die. Most are less than 30 years of     age. Not only are the health care costs staggering for both initial care and rehabilitation,     but the societal loss in terms of economic impact reaches into the billions of dollars     annually in the U.S. alone. Despite advances in neurosurgical interventions and intensive     care management, many survivors do not fully recover. A significant cause of this mortality     and morbidity is thought due to potentially preventable secondary injury, namely oxidant     injury, inflammation, and apoptosis in the penumbra (the area of brain surrounding the     primary lesion, which is at-risk, but potentially salvageable), beginning in the first few     hours after the severe traumatic event.      Despite the current bleak outlook for many of these patients, a series of animal     investigations have uncovered a promising solution to the problem of the secondary injury     seen in severe TBI and other similar processes, namely the early administration of estrogen,     a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound. Based on these     encouraging results from animal studies, the investigators hypothesize that early     administration of IV Premarin® in patients with severe TBI will safely reduce secondary brain     injury, improve neurological outcomes, and improve survival.   "
238193|NCT00973687|"     The purpose of this study is to assess whether smaller volumes of oral dexamethasone result     in better tolerability, specifically less vomiting, in pediatric patients during an acute     asthma exacerbation.   "
238194|NCT00973700|"     This study will evaluate the safety and immunogenicity of different combinations of A/H1N1     S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.   "
238310|NCT00976066|"     The purpose of this study is to determine whether GSK1521498 attaches to sites in the brain     called mu-opioid receptors that are involved in the liking reactions to palatable high fat     and high sugar foods. We hope that blocking these receptors may modify certain behaviours     that may lead to obesity.   "
238195|NCT00973713|"     This is a clinical trial investigating the effectiveness and safety of the study drug RAD001     in patients with advanced (metastatic) cholangiocarcinoma. Palliative chemotherapy provides     some benefit to this group of patients. However, chemotherapy treatment only shows low rates     of radiological response and short times to tumour progression. Therefore, further treatment     options are urgently required.      In laboratory studies, RAD001 has been shown to interrupt the signals that cancer cells use     to grow, spread and form new blood vessels (angiogenesis). RAD001 has been approved for the     treatment of kidney cancer. It has also been approved for use in Australia for the treatment     of patients with kidney and liver transplants, and has been used in thousands of patients     worldwide for this indication. Preliminary studies suggest that RAD001 may have activity in a     range of other cancers. This study will evaluate the activity of RAD001 in advanced     cholangiocarcinoma.   "
238196|NCT00973726|"     This project has the following specific purposes:        -  To develop a clinically usable test to determine the blood glucose level or HbA1c-level,          to which the retina is adapted. This will be performed by means of ERG implicit time          measurements in relation to the blood glucose level during an oral glucose tolerance          test (OGTT) and inter- or extrapolation to the level of blood glucose (or HbA1c) where          implicit time is normal.        -  To examine darkadaptation in diabetics in relation to changes in the glucose level.        -  To examine vessel diameter changes in diabetic individuals when changing the glucose          level transiently   "
238197|NCT00973739|"     The purpose of this study is to determine if Lapatinib has any effect on tumors found in     patients with Neurofibromatosis Type 2 (NF2). NF2 is a condition that mainly affects the skin     and nervous system. It causes non-cancerous tumors (which are known as neuromas) to grow on     the nerves around a person's body. Some signs of NF2 include a gradual loss of hearing and     tumors growing on the skin, the brain and the spinal cord which can lead to complications.      Lapatinib is an oral drug that is approved by Food and Drug Administration (FDA) for other     types of tumors, it is not approved by the FDA for treatment of NF2 related tumors. The     investigators know a lot about how well it is tolerated, but the investigators do not know if     it is effective in treating your condition, therefore it is considered to be an     investigational medication. This study will test whether Lapatinib may shrink tumors commonly     found in patients with NF2 or stop them from growing. This will help us to decide if     Lapatinib should be used to treat NF2 patients in future. Lapatinib is a drug that has been     used for over 10 years to treat various forms of cancer. It has not been studied for the     treatment of tumors in NF2 patients.   "
238198|NCT00973752|"     The purpose of this study is to determine the safety and effectiveness of a multi-drug     regimen (which includes prednisone, vincristine, cytarabine, doxorubicin, 6 mercaptopurine,     and methotrexate) which is considered standard treatment for children and young adults with     acute lymphoblastic leukemia (ALL), in combination with PEG-asparaginase and clofarabine to     treat older adults with ALL. PEG-asparaginase has been used in chemotherapy treatment     regimens for both children and adults with ALL. Clofarabine has been used in chemotherapy     treatment regimens for children with ALL and has been shown to decrease the number of     leukemia cells. Participants with leukemia that has an abnormal chromosome, called the     Philadelphia chromosome, will also be given imatinib.   "
238199|NCT00973765|"     Patients will be enrolled in a multi-center study to prospectively evaluate outcome after     treatment for an uncomplicated skin abscess. All patients will receive incision and drainage     and wound cultures. Patients will then be randomized to 1) placebo two tablets PO BID X 7     days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the     emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary     outcome is treatment failure rates at 7 days after incision and drainage. Patients who are     clinically worsening or not improving after 48 hours will then be treated with additional     antibiotics or admission if needed. Data will be analyzed both by initial randomization and     intention to treat.   "
238200|NCT00973778|"     Intensity modulated radiotherapy (IMRT)-based radiation therapy that delivers a high dose of     radiation directly to the tumor may kill more tumor cells and cause less damage to normal     tissue. Investigators initiated a prospective study to evaluate the efficacy and toxicity of     short course preoperative chemoradiotherapy utilizing Intensity Modulated Radiation Therapy     (IMRT) in combination with capecitabine in patients with resectable rectal carcinoma.   "
238201|NCT00973791|"     Fluid management plays an essential role in cesarean section. In previous study (NCT00488111)     the investigators found that prior-epidural anesthesia fluid management produced a more     significant role in stabilizing the blood pressure and better prognosis after cesarean     delivery than that of the posterior-anesthesia ones. Given epidural anesthesia has a time     interval before reaching the best state of anesthesia, so the fluid management also has a     relatively adequate time to resuscitation. In reality, spinal anesthesia is used popularly     except for the epidural anesthesia, whereas spinal anesthesia would produce more significant     fluctuation of the hemodynamics compared with the latter. Herein the investigators proposed     whether the prior-spinal anesthesia fluid management also produced similar effect on     hemodynamic characteristics to the epidural anesthesia.   "
238212|NCT00973947|"     RATIONALE: Using a customized headrest to hold patients in one position may help doctors plan     treatment for patients with head and neck cancer. It is not yet known whether a customized     headrest is more effective than a standard headrest in holding patients still during     radiation therapy.      PURPOSE: This randomized clinical trial is studying a customized headrest to see how well it     works compared with a standard headrest in holding patients still while undergoing radiation     therapy for head and neck cancer.   "
238213|NCT00973960|"     The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier     Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes.      The primary efficacy endpoint is an assessment of glycemic control at week 24 or last     assessment measured via HbA1c.   "
238214|NCT00973973|"     The purpose of this study is to evaluate NBI-56418 compared to placebo (also known as a sugar     pill) for its effects on endometriosis related pelvic pain and its safety.   "
238215|NCT00973986|"     The aim of the study is to investigate the effects of CYP3A polymorphisms on the     pharmacokinetics of Atorvastatin in Chinese subjects with coronary heart disease.   "
238202|NCT00973804|"     Background:        -  Allogeneic stem cell transplantation (SCT) has been used to treat many kinds of cancer          or pre-cancerous conditions that develop in blood or immune system cells. Umbilical cord          blood transplantation (UCBT) is a type of allogeneic transplant that is used when none          of a patient s siblings are a match and an acceptable match cannot be identified from          one of the bone marrow registries. Prior to receiving the cord blood stem cells, large          doses of chemotherapy drugs and/or radiation have been traditionally used to eliminate          most of the cancerous or abnormal cells from the recipient s system, along with most of          his or her own stem cells and immune cells. Donor stem cells then replace the recipient          s stem cells in the bone marrow, restoring normal blood production and immunity. In this          way, an allogeneic SCT provides not only new blood cells but an entire new immune          system.        -  In the past, allogeneic SCT was performed with very high doses of chemotherapy and/or          radiation to get rid of as much of the recipient s cancer as possible and prevent          rejection of the treatment. However, intensive chemotherapy or radiation can cause          serious side effects, including death. A newer method uses smaller, less toxic doses of          chemotherapy and/or radiation before allogeneic SCT. In these reduced-intensity stem          cell transplants, the recipient s stem cells and immunity are not completely eliminated,          but they are weakened enough to help prevent the donor s cells from being rejected.      Objectives:      - To study the safety and effectiveness of reduced-intensity stem cell transplants given with     immune-depleting chemotherapy and umbilical cord blood provided by an unrelated donor.      Eligibility:        -  Individuals between 18 and 69 years of age who have been diagnosed with any of a number          of cancerous and pre-cancerous blood conditions, including lymphoma and leukemia.        -  Participants must not have a potential donor sibling or a readily available unrelated          donor identified through one of the bone marrow donor registries.      Design:        -  Patients will be matched with at least two umbilical cords with an acceptable cell dose.          The two frozen umbilical cord blood units will be sent to the NIH prior to the date of          transplant.        -  Patients will receive one, two, or three cycles of chemotherapy (based on the type of          disease) to treat the disease and to weaken the immune system. Patients who already have          a weakened immune system from other treatments will not receive this round of          chemotherapy.        -  Patients will then receive 4 days of reduced-intensity transplant chemotherapy (also          called the conditioning regimen ) to prepare for the transplant.        -  Two days after transplant chemotherapy, patients will receive the transplant, with the          two umbilical cords infused one after the other on the same day. Patients will receive          additional treatment to prevent complications.        -  Patients will remain in the hospital for 4 to 6 weeks after the transplant, and will be          discharged for outpatient treatment when the study doctors deem it appropriate.        -  Patients will continue on medications at home to lower the risk of complications and          infections, and will visit the NIH clinic regularly for the first 6 months after the          transplant, and then less often for at least 5 years afterward.   "
238203|NCT00973817|"     The purpose of this study is to investigate the safety and efficacy of the use of ELAD in     patients with diagnosed Acute On Chronic Hepatitis, including Acute Alcoholic Hepatitis.   "
238204|NCT00973830|"     Objective: to evaluate the efficacy of the American College of Physicians Foundation (ACPF)     Diabetes Guide (Living with Diabetes: An Everyday Guide for You and Your Family) to improve     diabetes self-management.      Study Sites: Nine Federally-qualified health centers or safety-net clinics at three sites in     Missouri. Sites are urban (St. Louis), midsize (Columbia) and rural (Kirksville). Three FQHCs     or safety net clinics are located at each of the sites.      Methods Overview and Design: A randomized controlled trial will be conducted. Patients will     be recruited from identified health centers. As the intervention itself is directed to the     clinic and not patient, the clinics will be randomly assigned to either 1) usual care (no     treatment), 2) Carve-In - patients receive the Diabetes Guide and clinic staff follow-up     and work with patients to create and complete action plans or 3)Carve-Out - patients     receive the Diabetes Guide and a diabetes educator in Chicago follows up and works with     patients to create and complete action plans. Recruited subjects will be administered a     baseline assessment, and 3-month and 1-year follow-up assessments.      Sample: The investigators will recruit a total of 1,080 patients (n=120 per clinic)     anticipating 80 percent retention through both follow-up assessments (final estimated number     of patients = 720). Eligibility to participate will be defined as patients 1) ages 30 and     older (to better represent disease distribution), 2) English or Spanish-speaking, 3) a     confirmed (by chart) diagnosis of uncontrolled diabetes (HBA1c 7.0 or more).   "
238205|NCT00973856|"     The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to     treat warts located on the hands.   "
238206|NCT00973869|"     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of curcumin may prevent or treat colorectal cancer.      PURPOSE: This phase I trial is studying the side effects of curcumin in preventing colorectal     cancer in patients undergoing colorectal endoscopy or colorectal surgery.   "
238207|NCT00973882|"     The aim of our study is to assess the efficacy and toxicity of a chemotherapy regimen     combining carboplatin and etoposide in patients with metastatic hormone-resistant prostate     cancer and neuro-endocrine differentiation. Eligible patients are treated with the     combination of carboplatin AUC4 on day 1 and etoposide 100 mg/m2 on day 1, day 2 and day 3     repeated every 3 weeks for a maximum of 6 cycles. Efficacy endpoints include Prostate     Specific Antigen (PSA) and neuro-endocrine marker response (defined as a 50% or greater     decrease from baseline serum values), objective response rate (according to RECIST criteria),     and toxicity.   "
238208|NCT00973895|"     Background:        -  Vaccines are substances used to try to create resistance (or immunity) to a disease and          to prevent an infection. Researchers are testing a new DNA vaccine designed for a new          type of influenza, often referred to as swine flu. The DNA vaccine will instruct the          body to make a particular kind of influenza protein that the immune system will be able          to recognize.        -  Researchers are interested in determining if the vaccine is safe and effective in          humans, and would like to study the immune system's response to the vaccine. The vaccine          will not give participants influenza; however, it may not be effective in preventing          them from getting influenza at a later date.      Objectives:        -  To evaluate the safety and tolerability of the VRC-FLUDNA057-00-VP influenza vaccine as          administered to healthy adults.        -  To evaluate antibody responses to the new influenza vaccine.      Eligibility:      - Healthy adults between the ages of 18 and 70.      Design:        -  Participants will have seven planned clinic visits during this study (enrollment day and          study weeks 1, 4, 8, 9, 12, and 32).        -  All participants will receive three injections of the test vaccine, given as individual          doses on day 0, day 28, and day 56 of the study. The vaccine will be given in the upper          arm muscle.        -  Injections will be given using a needleless system that delivers the vaccine through the          skin by using the pressure of carbon dioxide to inject the vaccine through the skin and          into the muscle. Participants will remain at the National Institutes of Health (NIH)          Clinical Center for at least 30 minutes after the injection to be monitored for any          reaction.        -  Participants will be asked to keep a 7-day diary card after each injection to record          their physical reactions to the vaccine.        -  Participants will be asked to return to the NIH Clinical Center as requested by          researchers for additional blood tests and other procedures, as required by the study.   "
238209|NCT00973908|"     The investigators aim to investigate whether the routine use of the probiotic formulation     VSL#3 co-prescribed with antibiotics reduces the incidence of both Antibiotic associated     diarrhoea and Clostridium Difficile associated diarrhoea.   "
238210|NCT00973921|"     The primary objective of this study is to determine the diagnostic efficiency and accuracy of     using the StentOptimizer. The ability of StentOptimizer to influence post deployment     treatment strategy will be assessed and compared to the IVUS system. In addition, the     correlation of diameter measurements between the StentOptimizer, IVUS and 2D QCA will be     assessed. The StentOptimizer software, IVUS and 2D QCA were all part of the clinical     procedure outside the study. The analysis of post deployment treatment decisions and diameter     measurements using those modalities retrospectively make this an observational study.   "
238211|NCT00973934|"     This two-center, between-subject, randomized, double-masked study (n=20) will provide the     first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast     the therapeutic properties and side effects of two forms of MST in patients in a major     depressive episode (MDE).   "
238216|NCT00973999|"     TITLE      A randomised placebo controlled trial to explore the effectiveness of Botulinum Toxin     injection at reducing oral secretions and frequency of tracheal suctioning in tracheotomised     patients.      DESIGN      Randomised controlled single blinded experimental design      AIMS      The purpose of this study is to determine if ultra-sounded guided injections of Botulinum     Toxin into the salivary glands (Parotid and sub-mandibular glands) of patients with a     tracheostomy tube in-situ assists in the reduction of oral secretions.      OUTCOME MEASURES      Amount of saliva production / frequency of tracheal suctioning / questionnaires.      POPULATION      In-patients at the Wellington Hospital based in London will be invited to participate within     the study. Participants will be recruited from a range of wards which will include the     Intensive Treatment Unit (ITU), acute medical wards and rehabilitation wards. All     participants will have a tracheostomy tube in-situ and be breathing on room air, without the     need for any mechanical ventilation. Participants will be receiving tracheal suctioning to     assist in the clearance of saliva to maintain a clear airway.      A total of 40 participants will be recruited to the study across a two year period.      Each participant will have no prior history of the following:        -  swallowing disorders        -  stroke        -  myocardial infarction        -  head or neck surgery        -  respiratory disease        -  acute or progressive neurological disease        -  structural abnormalities that could affect swallowing        -  other medical conditions requiring medication that could affect swallowing.      ELIGIBILITY      Male and female adults over the age of 18 years      TREATMENT      Injection of Botulinum Toxin into both pairs of the parotid salivary glands and submandibular     glands, using ultrasound guidance      DURATION      Data collection over a two year period / six weeks for each participant   "
238217|NCT00974818|"     The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and     Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will     get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get     both.      The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the     diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even     after the doctor removes the tumors, the cancer can return. In this case, the doctor will put     medicine into the bladder to destroy cancer cell. This is called intravesical therapy. The     two most commonly used drugs for this purpose are MMC and BCG.      Both drugs have been studied for many years. They both show good results when compared to     other treatments. They have not been studied using the schedule that will be used in the     study. The doctor does not know if these two drugs are equally effective in treating the     cancer and preventing recurrence.      BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG     is better than a short schedule of MMC. They have also shown that the side effects of BCG are     more intense than with MMC. A recent study showed that a new dose of MMC is better than the     old standard dose. Since the side effects of MMC occur less often, it is important to learn     whether the two drugs are equally effective. That could help us decide between the     treatments. In this study, the doctor will compare MMC and BCG when given for the same amount     of time. The doctor hopes the study will tell us which drug is more effective in preventing     the return of the cancer.   "
238218|NCT00974831|"     The primary objective is to compare the postprandial glycemic response of healthy overweight     adults after consuming an amino acid drink mix versus a control drink.   "
238219|NCT00974844|"     Dropping of nucleus is a common complication during cataract extraction by     phacoemulsification. The investigators describe a new technique to retrieve the dropped     nucleus by using an instrument called Pars Plana Levitator (ASICO-LLC, USA).   "
238220|NCT00974857|"     This prospective, randomized, controlled study aims to evaluate the usefulness of the new     body composition monitor (BCM) device as a method to improve volume control in hemodialysis     (HD) patients and compare the results with those obtained by conventional volume control     modalities.   "
238221|NCT00974870|"     The primary objective of this study is to determine the efficacy of a needling device for     treatment of acne scars.   "
238222|NCT00974883|"     Giant Cell Arteritis (GCA) causes inflammation and narrowing of blood vessels and can cause     blindness in one third of patients. It is important that a prompt, accurate diagnosis of GCA     is made and treatment given as steroids for two or more years. Currently there is no 100%     accurate test for GCA. Patients usually have new headache and scalp tenderness, typically     with an abnormal blood test. However, it can be difficult to distinguish non-serious forms of     headache from GCA; infection produces similar abnormal blood results. If there is a suspicion     of GCA, treatment with steroids is started straight away. To confirm a diagnosis, the patient     will need a biopsy of a temporal artery (a minor procedure performed under local anaesthetic     to remove a sample of one of the scalp arteries). However, up to 44% of patients will have a     normal biopsy. Therefore it is difficult to know if a patient with a normal biopsy does or     does not have GCA. Withdrawing steroid treatment may increase the risk of blindness.     Continuing treatment in a patient without GCA increases the risk of side effects (e.g.,     weight gain, infection risk, osteoporosis and fracture risk, high blood pressure, diabetes,     cataracts). It is important to improve diagnostic tests for GCA. Another test to help in     diagnosing GCA is an ultrasound scan of the arteries in the side of the head and under the     arms. Ultrasound does not involve surgery; it is a simple test which can be performed as an     out patient. Gel is applied to both sides of the head and under each arm. A sound probe is     placed over the artery at each site to produce the scan.      The investigators' study will examine the role of ultrasound in diagnosis of 402 patients     with suspected GCA. All patients will have an ultrasound examination in addition to biopsy     within a week of starting steroids. Patients will be treated according to usual practice.     After six months, the investigators will reassess the diagnosis. The investigators will look     at the accuracy of ultrasound compared with or combined with biopsy. The investigators will     look at how a doctor's knowledge of ultrasound results or biopsy results alone would affect     the diagnosis and recommendation to continue or stop steroid treatment. The investigators     will assess whether knowledge of both results together would alter the diagnosis and     treatment. The investigators will collect information to estimate the costs of different ways     of diagnosing GCA in relation to the impact on quality of life.   "
238223|NCT00974896|"     To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in     combination with bevacizumab, sorafenib, panitumumab, erlotinib, or gemcitabine in subjects     with advanced solid tumors. Up to 126 subjects may be enrolled. Sorafenib and erlotinib combo     cohorts are enrolling. All other combo cohorts are closed to enrollment.   "
238238|NCT00975091|"     The purpose of the study is to determine if treatment with entecavir is safe and well     tolerated in patients who completed dosing in a previous entecavir study in China, but are     requiring further treatment of their chronic hepatitis B virus infection.   "
238239|NCT00975104|"     Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and     Efficacy of AMG 745 in Age-associated Muscle Loss   "
238240|NCT00975117|"     The purpose of this study is to determine whether the administration of the dietary     supplement Spermotrend improves spermatogenesis parameters in subjects with male infertility     unrelated to major testicular conditions. The duration of this double-blind placebo     controlled phase 3 clinical trial will be 24 weeks. The estimated number of males with     infertility to be recruited and randomized for the study is 86.   "
238241|NCT00975130|"     Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab     administered by autoinjector once monthly, when combined with different disease-modifying     antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2     will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC     golimumab to retain remission is superior to continuing a SC regimen.   "
238224|NCT00974909|"     Background of the study:      Fecal incontinence is a complex problem. The social consequences of this problem result in a     lower quality of life. The exact prevalence of FI is unknown, literature reports vary from     13-19%. There are variable treatment options depending on the patient and the etiology of the     FI. Dietary manipulation, pharmacological intervention, pelvic floor physiotherapy, as well     as surgical interventions are currently used to treat FI.      A promising current treatment is Percutaneous Tibial Nerve Stimulation (PTNS). The nerves in     the spine that control bowel function also have branches which go to the ankle. Stimulating     these nerves in the ankle has shown to be an effective treatment for FI in the short-term.     The treatment has been shown to be safe and well tolerated by subjects with almost no     morbidity in prior urology trials.      Objective of the study:      The objective of this study is to show that the results of PTNS are based on the treatment of     electrical stimulation and not on a placebo effect with a sham treatment.      Study design:      This study is a multicenter, single-blinded, randomized, placebo-controlled trial.      Primary study parameters/outcome of the study:      The percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from     baseline after 9 weeks of treatment.      Secondary study parameters/outcome of the study (if applicable):      Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI Score)      Mean change in Quality of Life scores in validated QoL questionnaires (SF-36, Digestive     Health Status Instrument (DHSI), and Fecal Incontinence Quality of life)      Subject's and Physician's Global Impression   "
238225|NCT00974922|"     This study will evaluate the effects of Vitamin D replacement and the effects of an approved     medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who     have low levels of vitamin D in their blood. The study will compare the effects of vitamin D     or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.   "
238226|NCT00974935|"     The main purpose of this study is to test the safety of a new vaccine, STEBVax, which may     lead to a useful treatment for toxic shock syndrome. The second purpose is to determine     whether STEBVax causes the body to produce antibodies (proteins that fight infection) to help     the body resist disease. Researchers expect STEBVax shots will cause the development of     antibodies in the blood. Study participants will include up to 42 healthy adults, ages 18-40,     from the University of Maryland Baltimore community. Participants will be assigned to one of     7 vaccine dose groups. Assignment to dosage groups will depend on when individuals are     enrolled in the study. Study procedures will include blood sampling, urine collection, and     physical examinations. Subjects will maintain a memory aid documenting daily oral     temperatures and possible vaccine side effects. Participants will be involved in study     related procedures for up to 201 days.   "
238227|NCT00974948|"     Pancreatic cancer presents with pain in the majority of cases. Destruction of the celiac     ganglia by ultrasound guided injection of sclerosing agents such as alcohol is sometimes used     for pain that no longer responds to treatment with narcotics. The investigators compare     standard narcotic treatment to celiac plexus alcohol injection (celiac plexus neurolysis) and     do so in patients with early, mild pain to see if celiac plexus neurolysis is more effective     than narcotics and prevents escalating narcotic use.   "
238228|NCT00974961|"     The purpose of this study is to compare if the effect of levobupivacaine on autonomic nervous     system smaller than that of bupivacaine.   "
238229|NCT00974974|"     This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's     disease.   "
238230|NCT00974987|"     RATIONALE: Boron neutron capture therapy and radiation therapy use high-energy x-rays and     other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving boron neutron capture therapy followed by     radiation therapy and temozolomide may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving boron neutron capture     therapy together with radiation therapy and temozolomide in treating patients with newly     diagnosed glioblastoma multiforme.   "
238231|NCT00975000|"     Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT     often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the     neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can     cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT     may include increases in blood levels of calcium (hypercalcemia) and low blood levels of     phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body     tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation,     itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant     dysfunction (worsening of kidney transplant function). The purpose of this study is to     evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in     patients with HPT after a kidney transplant.   "
238232|NCT00975013|"     The objective of this study is to assess changes bone mineral density and bone metabolism     after laparoscopic Roux-en-Y gastric bypass surgery. The investigators hypothesize that     weight loss after laparoscopic Roux-en-Y gastric bypass surgery will be associated with     increased bone turnover, changes in bone metabolism, and loss of bone mass.   "
238233|NCT00975026|"     The purpose of this study is to determine whether the effects of chair massage and/or chair     massage with stretching may reduce musculoskeletal pain and discomfort related symptoms     associated with the job duties of a cardiac sonographer.   "
238234|NCT00975039|"     The aim of this study is to evaluate the safety of Vascular Targeted Photodynamic therapy     with WST11 in patients with non-resectable or inoperable biliary carcinoma.   "
238235|NCT00975052|"     This study will determine the effect of concomitant administration of sitagliptin and     metformin on post-meal incretin hormone concentrations in healthy adults.   "
238236|NCT00975065|"     The study design of this trial is open-label, randomized, multi-center, parallel-group study.   "
238237|NCT00975078|"     Suppression of the adrenal function is a common, potentially dangerous and unpredictable     consequence of short term high dose glucocorticoid treatment. Identification of patients at     risk would be of high clinical importance. The investigators hypothesized that the     dexamethasone-suppression-test predicts the subsequent development of corticosteroid induced     adrenal insufficiency.   "
238243|NCT00975156|"     The purpose of this research study is to look at a new rehabilitation technique for     individuals who have suffered a stroke and have difficulties walking. This study is designed     to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in     order to improve walking post-stroke. This research project will be conducted as a pilot     randomized controlled trial that compares the effectiveness of Lokomat versus conventional     physical therapy in improving the ambulation and gait of chronic stroke patients. The project     will provide important pilot data that could indicate whether or not the effectiveness of     Lokomat training is superior to that of standard physical therapy and if a definitive and     larger clinical trial is warranted.   "
238244|NCT00975169|"     According to the above evidence, though the exact mechanism contributing to the     Thiazolidinediones (TZDs) associated peripheral edema is still unclear, the investigators     hypothesize that the genetic variations of certain candidate genes involved in peroxisome     proliferator-activated receptor (PPAR) gamma itself and PPAR gamma-regulated genes may     contribute to TZDs-associated peripheral edema. Therefore, the investigators plan to conduct     a case-control study to test the association between single nucleotide polymorphisms (SNPs)     in certain candidate genes and TZDs related peripheral edema.      A large fraction of individuals, both with type 2 diabetes (38-41) or who are at risk for     type 2 diabetes, do not respond to TZD therapy. In individuals with type 2 diabetes,     non-response has not been carefully characterized, but data from studies in at-risk     individuals suggests that a lack of improvement in insulin sensitivity (Si) may account for     the lack of response to TZD therapy. In the Troglitazone In the Prevention Of Diabetes     (TRIPOD) study, around 30% of treated women did not show an improvement in Si; they gained no     protection from type 2 diabetes when compared with the placebo group. Assessment of baseline     clinical and physiologic measurements revealed similar levels of adiposity, fasting glucose     and insulin, Si and β-cell function, fasting lipids, contraceptive use, and compliance with     study medication between responders and nonresponders, suggesting that these measures do not     predict TZD response.      The adipose tissue-derived hormone adiponectin improves insulin sensitivity and its     circulating levels are decreased in obesity induced insulin resistance. In ob/ob mice lacking     adiponectin, the ability of PPARγ agonists, TZDs, to improve glucose tolerance is diminished.     It implied that adiponectin is an important contributor to PPARγ-mediated improvements in     glucose tolerance through mechanisms that involve the activation of the AMPK pathway. On the     other hand, it has been shown that FOXO1 repressed PPARγ1 and γ2 promoters in primary     adipocytes. It has also been reported that peroxisome proliferators activated receptor-γ     coactivator-1α (PGC-1α) gene expression in brown and white adipocytes is a direct target of     TZDs and activators of retinoid X receptor (RXR). Taken together, both FOXO1 and PGC-1α     potentially played important roles on the antidiabetic action of TZDs.      In summary, though TZDs have been widely used in patients with type 2 diabetes mellitus, some     of patients experienced TZD-related peripheral edema and some of patients had no good     responsiveness to TZDs. The underlying contributing factors and molecular mechanisms have not     been clearly elucidated. In this study, the investigators will identify the contributing     factors of TZD-related peripheral edema and responsiveness to TZDs. The investigators will     also identify the association of single nucleotide polymorphisms (SNPs) of certain candidate     genes with TZD related peripheral edema and responsiveness to TZDs. It may identify some     clinical and pharmacogenetic factors to predict the occurrence of TZD-related edema and the     responsiveness to TZDs.   "
238245|NCT00975182|"     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,     tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination     with PO erlotinib in patients with advanced solid tumors and patients with locally advanced     or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior     chemotherapy regimen.   "
238246|NCT00975195|"     This is a randomised study to be conducted in patients with severe to very severe Chronic     Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients     to be continuously treated with an inhaled corticosteroid on top of two potent long-acting     bronchodilators. The study also aims to identify the type of patients who are likely to     benefit from inhaled corticosteroid maintenance therapy.   "
238247|NCT00975208|"     The closure of the alveolar cleft as part of cleft lip and palate deformities is a procedure     that, to this date, still demands great efforts from plastic surgeons. The feasibility of     periosteoplasty for reconstruction of the alveolar arcade as well as the use of electrical     stimulation in order to increase osteoneogenesis have been proven in the past. The present     study attempts to combine both procedures that have only been reported separately worldwide.     The objective of this study is to increase the osteogenic capacity and hence, dental     eruption.   "
238248|NCT00975221|"     This study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for     the reduction of hypercalcemia in patients with primary hyperparathyroidism for whom     parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but     who are unable to undergo parathyroidectomy.   "
238249|NCT00975234|"     The purpose of this study is to determine the benefit of autologous skeletal myoblast     injection in patients with old myocardial infarction and ventricular dysfunction versus     conventional revascularisation therapy.   "
238250|NCT00975247|"     Background: Achievement of colonoscopy outcomes depends on high-quality bowel preparation by     patients; yet inadequate preparation is common.      Objective: To develop and test an educational booklet to improve bowel preparation quality.      Design: Before-and-after study followed by randomized controlled trial.      Setting: Veteran Affairs medical center.      Patients: Patients undergoing outpatient colonoscopy      Measurements: The investigators first performed cognitive interviews to identify knowledge     and belief barriers to high-quality colonoscopy preparation. The investigators then created a     patient educational booklet addressing patient barriers to improve preparatory behaviors. The     investigators tested the booklet in 2 sequential studies: (1) controlled before-and-after     study in patients undergoing colonoscopy during 2 consecutive months: 1 without and 1 with     the booklet; (2) randomized controlled trial. The outcome in both studies was bowel     preparation quality measured on a 6-point Likert scale (>5=good). In each study the     investigators compared the proportion achieving a good preparation between groups and     performed logistic regression to measure the effect of the booklet on preparation quality     while adjusting for the purgative received.      Limitations: Unknown impact on polyp yield and cancer reduction.   "
238251|NCT00975273|"     For the proposed randomized controlled treatment study, the investigators plan to compare the     effects of this hypoventilation-based breathing training with a control intervention that     will focus on breathing regularity and awareness. The two therapeutic procedures are closely     matched on important variables such as duration and the nature of patient-therapist     interaction, monitoring asthma related status and the medication intake, use of scientific     equipment and monitoring devices to increase adherence, and initial plausibility. Asthma     patients who will be evaluated before, during, directly after, and at 2 months and 6 months     after training.   "
238330|NCT00976326|"     This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the     pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an     extent that the dose should be adjusted in subjects with impaired liver function compared to     the dose for subjects with normal liver function.   "
238418|NCT00968838|"     The goal of this clinical research study is to compare the effectiveness of a white blood     cell transfusion with radiated cells to a white blood cell transfusion with cells that have     not been radiated. The safety of this procedure will also be studied.   "
238252|NCT00975286|"     The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in     comparison to placebo, as an add-on treatment to insulin glargine and metformin with or     without thiazolidinediones (TZDs), over a period of 24 weeks of treatment.      The primary objective is to assess the effects of lixisenatide in comparison to placebo, when     added to insulin glargine and metformin, on glycemic control in terms of glycosylated     hemoglobin (HbA1c) reduction (absolute change) at Week 24.      The secondary objectives are to assess the effects of lixisenatide on the percentage of     patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%,     plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self     monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability     (including anti-lixisenatide antibody assessment), and to assess the impact on treatment     satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the     participating countries where it is validated.   "
238253|NCT00975299|"     Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography)     images obtained after a single intravenous injection of BAY86-4367 in patients with cancer   "
238254|NCT00975312|"     Background        -  Lentigines are usually the first sign of photoaging and may produce a significant impact          on patients' quality of life.        -  There is no a treatment of choice for this condition.        -  Solar lentigines and melasma share similar physiopathologic characteristics.        -  The triple combination (TC) cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone          acetonide 0.01%) has been effective and safe for the treatment of melasma and other          hyperpigmented lesions.      Hypothesis      * The TC cream will be effective and safe for the treatment of solar lentigines on the back     of the hands.      Patients and methods        -  22 patients with solar lentigines were selected and their right hand or left hand were          selected at random to be treated with either TC cream or tretinoin 0.05% cream once          daily for up 12 weeks.        -  Patients were instructed to apply both creams on the whole back of the hand and not only          in the lentigines, and to use a broad-spectrum sunscreen (SPF 50+, UVA-PF 28) daily in          both hands.        -  Clinical assessments of Target Lesion Pigmentation, Physician's Global Assessment of          Improvement and a Subject's Self-Assessment questionnaire were collected for data          analysis at weeks 4, 8, and 12 after starting the treatment and 3 month post-treatment.        -  Statistical methods: The ordinally scaled efficacy measures underwent rank          transformation and were analyzed by analysis of variance to test the null hypothesis of          no differences among treatments. We performed Mann-Whitney and Wilcoxon tests and the          XLSTAT 2009 software was used.   "
238255|NCT00975325|"     -  Type: Bioequivalence study in male healthy volunteers, therapeutical indication          (erectile disfunction) not studied        -  Products, dosage, and route of administration:             -  Test 1: Yohimbin Spiegel® (Desma GmbH, Germany), tablet containing 5 mg yohimbine               hydrochloride, oral administration             -  Reference: Yocon-Glenwood® (Glenwood GmbH, Germany), tablet containing 5 mg               yohimbine hydrochloride, oral administration        -  Duration of treatment:           2 single-dose administrations of 5 mg yohimbine hydrochloride each under fasting          conditions separated by a wash-out period of at least one week i.e. 6 treatment free          days between all administrations   "
238256|NCT00975338|"     This project will describe and evaluate the impact of a unique partnership model designed to     coordinate transfer of care by formally linking pediatric and adult heath care services. The     experiences of young people receiving this model of care will be compared and contrasted     against the experiences of young people receiving the current standard of care. Young people     with a diagnosis of CP, ABIc, and SB will be followed during the transition period.     Preparation for transition, health care, and transfer of care service delivery will be     detailed in a process evaluation. An outcome evaluation will measure the ability of the two     models of service to enable youth to maintain continuity within the health care system after     transitioning from pediatric to adult care. Secondary outcomes, including how health,     well-being, social participation, transition readiness, and health care utilization are     affected will also be explored.   "
238257|NCT00975351|"     The aim of this study is to calculate the plasma apparent volume of distribution of natural     folate to give a more accurate value for use in a mathematical model of apparent folate     absorption.   "
238258|NCT00975364|"     This pilot study is designed to investigate differences in folate-related genes (single     nucleotide polymorphisms) and their relationship to the species of folate present on red     blood cells.   "
238259|NCT00975377|"     The objective of this study is to determine whether hair clipping is non-inferior to no hair     removal in preventing superficial, deep, and organ space surgical site infections (SSI) in     patients undergoing various general surgical procedures, evaluated after surgery by an     assessor blinded to treatment allocation. Additional goals include evaluating wound     complications that arise in patients that have hair clipped and in patients that do not have     hair removed and determining the impact of clipping versus no hair removal and SSI versus no     SSI on length of hospital stay.   "
238260|NCT00975390|"     The aim of the present study is to investigate the effect of added protein+leucine or     caffeine to 1.2 g/kg/h CHO on the rate of post-exercise muscle glycogen re-synthesis in     healthy, recreational athletes.      The investigators hypothesize that both interventions (the addition of caffeine or     protein+leucine) will lead to higher glycogen re-synthesis compared to the ingestion of CHO     only, and that the co-ingestion of protein and leucine will result in the highest muscle     glycogen synthesis rates.   "
238311|NCT00976079|"     Participants diagnosed with tibial femoral knee osteoarthritis will be assigned to one of     three treatment groups including: active transcutaneous electrical nerve stimulation (TENS),     placebo TENS, and a control group. Assignment of conditions will be concealed. All     participants in each of the three groups will receive physical therapy for all 4 weeks of the     intervention. Main outcome measures will include quadriceps central activation ratio,     quadriceps torque production, WOMAC scores, visual analog pain scores during gait as well as     knee joint kinetics and kinematics during gait. The purpose of this study is to to determine     if the continuous use of TENS therapy for activities of daily living and rehabilitation will     positively impact all outcome measures.   "
240452|NCT01003886|"     This study aims to assess the safety, tolerability and efficacy of Doxazosin GITS in Filipino     patients diagnosed with Benign Prostatic Hyperplasia (BPH) under the usual clinical care     setting.   "
238261|NCT00975403|"     Chronic obstructive pulmonary disease (COPD) is a growing cause of death, disability and     health care costs in Canada. Nevertheless, COPD remains largely under-diagnosed and     under-treated, particularly in its early stages. Patients with mild COPD have variable     respiratory symptoms and often go unrecognized by their caregivers. Recent studies indicate     that even smokers with near normal breathing test results can have extensive small airway     disease/dysfunction at rest, which becomes more pronounced during the stress of exercise thus     leading to unpleasant breathing difficulty. This study seeks to better understand the nature     and causes of breathing discomfort and activity limitation in a group of patients with mild     COPD. The investigators will compare detailed tests of small airway function and conduct an     evaluation of several key physiological parameters during the stress of exercise in patients     with mild COPD and in healthy, age-matched, non-smoking control subjects. The investigators     will also compare detailed physiological responses to exercise under conditions of chemical     loading and mechanical unloading of the respiratory system in patients with mild COPD.      The proposed study will be the first to systematically test the hypothesis that     pathophysiological abnormalities in ventilatory demand, pulmonary gas exchange, small airway     function, dynamic ventilatory mechanics and respiratory muscle function contribute     significantly to exertional dyspnea and activity-limitation in patients with mild COPD. This     study will be the first to determine if these abnormalities can be manipulated.   "
238262|NCT00975416|"     Background:      - The therapeutic alliance between therapist and patient may contribute to favorable outcomes     in all types of psychotherapy, including cognitive behavioral therapy (CBT) for drug     dependence. Oxytocin, a hormone and neurotransmitter, has been shown to increase trust in     other people and may reduce stress and improve comfort in social situations by decreasing the     sensation of social anxiety. Researchers are interested in determining if oxytocin can     improve the outcomes of therapy for drug dependence by strengthening perceived levels of     trust between therapist and patient.      Objectives:      - To determine whether oxytocin enhances the therapeutic alliance and treatment retention for     CBT for drug use.      Eligibility:      - Individuals between 18 and 65 years of age who are healthy volunteers with no history of     drug abuse, participants in outpatient or inpatient treatment programs for cocaine use,     methadone-dependent participants in a treatment program, or non-treatment-seeking cocaine     users.      Design:        -  Participants in each treatment arm who comply with the study requirements will be          randomly assigned to receive one dose of oxytocin or placebo approximately 1 hour before          each weekly CBT session.        -  The outpatient treatment intervention will be 12 weeks of weekly individual CBT. The          inpatient treatment intervention will be 6 weeks of twice-weekly individual CBT          sessions. Sessions will be audiotaped. Participants and counselors will be told that the          sessions are to be taped.        -  During treatment, participants will provide urine and breath samples under staff          observation. Participants will also complete questionnaires about mood and mental          health, provide other samples as required, and participate in computerized psychological          testing as directed by researchers.   "
238263|NCT00975429|"     The aim of this trial is to determine the optimal treatment conditions to achieve prostate     cancer tumour ablation and to assess the effects of WST11-mediated Vascular-Targeted     Photodynamic therapy (VTP) treatment in patients with localized prostate cancer.      The secondary objectives are to assess the safety and quality of life following     WST11-mediated VTP treatment,to assess the effects,safety and quality of life following a     second WST11-mediated VTP treatment; and to explore optimisation techniques to reduce the     duration of the VTP procedure.   "
238264|NCT00975442|"     The purpose of this study is to evaluate eccentric training as an intervention for lateral     epicondylalgia (tennis elbow) in a clinical setting.   "
238265|NCT00975455|"     The purpose of the study is to evaluate subjects with gross or microscopic hematuria     undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.   "
238266|NCT00975468|"     Compared with the information available in sepsis and trauma-associated ARDS, less is known     about the cause and pattern of lung injury after thoracic surgery. Definition of lung injury     in this context is difficult. Most now use the joint North American-European consensus     conference definitions, but these are based only on gas exchange and radiology criteria.     While gas exchange measures are reliable, thoracotomy inevitably causes radiological change     and the interpretation of plain chest films becomes subjective. Definitions based on     permeability and inflammatory changes would improve diagnosis, but are not routinely     available in most units.      Pressure-controlled volume (PCV) may be useful to improve gas exchange and alveolar     recruitment with associated lower airway pressures and shunt fraction during one-lung     ventilation (OLV).      However, a recent prospective randomized study of the effects of PCV during OLV did not lead     to improved oxygenation during OLV compared with VCV, but PCV did lead to lower peak airway     pressures. To date, there are no reports of the effects of PCV versus VCV during OLV on the     acute lung injury (ALI) after thoracotomy.   "
238267|NCT00975481|"     Dimebon will not exhibit abuse potential when compared to placebo or a positive control     (alprazolam).   "
238268|NCT00975494|"     In heart failure (HF), a defective nitric oxide (NO) signaling may be involved in left     ventricular (LV) diastolic abnormalities and LV remodelling progression. PDE5-inhibition, by     blocking NO degradation and overexpressing cellular cyclic guanosine monophosphate (cGMP)     pathways might be beneficial. Several short term studies have demonstrated safety and     clinical improvement in stable heart failure (HF) patients.      The purpose of this study is to test the effects on LV diastolic function, cardiac geometry     and clinical status in a cohort of HF patients.   "
238269|NCT00975507|"     This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant     administration of Varivax and M-M-R II vaccines in healthy children.   "
238270|NCT00975520|"     This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus     post-operative radiation therapy for patients with completely resected primary melanoma     showing histological features of neurotropism. Uncontrolled studies suggest that this form of     primary melanoma has a high risk of local recurrence and that postoperative radiation therapy     may substantially reduce that risk. Patients who are eligible on the basis of the pathology     of the excised melanoma will be offered the opportunity to take part in the trial. Those     randomised to receive radiation therapy will be treated with a simple technique encompassing     the surgical bed plus a margin. Radiation will commence within 3 months of surgery (maximum     of 14 weeks from surgery to start of radiotherapy).   "
238271|NCT00975533|"     This study aims to analyze the pre- and post-operative clinical, hormonal and biochemical     changes in moderately obese type 2 diabetic patients who are sub-optimally controlled on at     least 2 anti-diabetic agents. Study participants will either receive implantation of the     gastric contraction modulator or conventional treatment with insulin therapy.   "
240469|NCT01004107|"     The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable     Dermal Filler for hand treatment.   "
238272|NCT00975546|"     The investigators propose to treat couples who wish to have a child in which the man is     HIV-positive and the woman is HIV-negative. The investigators call these couples     HIV-discordant. On the average, an HIV-positive man, who does not participate in high-risk     activities, will transmit HIV to a female partner one in every one thousand acts of     intercourse without a condom. To reduce transmission of HIV, HIV-discordant couples are     counseled to avoid intercourse altogether, or to use condoms during every act of intercourse.     In order to have a child, these patients can use donor insemination. If they wish to have a     natural child of the infected man, they can use a combination of medication of the man to     reduce the amount of virus in his semen, and condom use except at the time of ovulation when     the woman produces an egg. This reduces the chance of infecting the woman, but studies have     shown that about 4% of women will be infected with HIV using this approach. Alternatively,     they can use vitro fertilization (IVF) with intra cytoplasmic sperm injection (ICSI) in which     eggs are collected from the woman after hormone-stimulation and are fertilized in the     laboratory by injecting a single washed sperm from her husband into each egg. The resulting     embryos can be transferred to the wife's uterus and/or frozen for later use. These procedures     are believed to minimize the risk of HIV transmission (although the number of cases is low),     but IVF-ICSI is very expensive and are not an option for everyone. A simpler method used for     over 15 years in Europe is to collect the man's semen, wash the sperm in the laboratory, and     test the sperm sample for HIV before placing it in the woman's uterus (intrauterine     insemination; IUI). Although the risk of HIV transmission to the woman is presumably not zero     with this method, over 4000 inseminations reported have not resulted in infection of any     female patients or resulting children.   "
238273|NCT00975559|"     The aim of this study is to measure how different people respond to mental stress. The     investigators will measure if there are differences in cardiovascular responses to mental     stress among different groups of subjects. In one part of the study the investigators will     compare the cardiovascular responses to mental stress between healthy women and healthy men.     In another part of the study, the investigators will compare the cardiovascular responses to     mental stress between women with apical ballooning syndrome and healthy post-menopausal     women. The investigators hypothesize that healthy men will have an increased vascular     response to and decreased endothelial function in response to to mental stress, compared to     health women. Furthermore, the investigators hypothesize that women with apical ballooning     syndrome will have an increased vascular response to and decreased endothelial function in     response to mental stress.   "
238274|NCT00975572|"     The primary safety objective of this study is to assess the safety of split- virion     inactivated H1N1 vaccine with and without adjuvant when administered at the 7.5,15 or 30 mcg     dose. The primary immunogenicity objective is to assess the antibody response following each     dose of split- virion inactivated A(H1N1) vaccine with and without adjuvant. Participants     will include up to 2200 healthy persons age 3 and older who have no history of novel     influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is a randomized,     double-blinded, Phase II study in healthy males and non-pregnant females, aged 3 years and     older. Subjects will be stratified by elders (equal to or more than 61 years), adults (18-60     years), adolescents (12-17 years) and children (3-11 years), elders and adolescents will be     randomized into 5 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or     non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), children will be randomized into 4     dose groups (adjuvanted H1N1 vaccine of 7.5 or 15 mcg per dose or non-adjuvanted H1N1 vaccine     of 15 or 30 mcg per dose), adults will be randomized into 6 dose groups (adjuvanted H1N1     vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose     or placebo), 110 subjects per dose and age stratum will be to receive intramuscular influenza     H1N1 vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. Following     immunization, safety will be measured by assessment of adverse events through 21 days     following the last vaccination (Day 42 for those receiving both doses), serious adverse     events and new-onset chronic medical conditions through 6 months post the final vaccination     (Day 180 after second vaccination), and reactogenicity to the vaccine for 8 days (Day 0-7)     following each vaccination. Immunogenicity testing will be hemagglutination inhibiting (HAI)     on serum obtained on the day 21 of each vaccination (prior to vaccination), on Day 21 after     first vaccination, and 21 days following the second vaccination (Day 42).   "
238275|NCT00975585|"     The purpose of this study is to compare the clinical performance of two contact lenses.   "
238276|NCT00975611|"     The purpose of this study is to show that amantadine might help to reduce the side effect of     the medications which are prescribed to treat schizophrenia or schizoaffective disorder. High     level of hormone prolactin, or hyperprolactinemia, is one of the side effects which might be     developed in patients treated with the paliperidone ER or risperidone Consta.      High level of prolactin might stimulate breast development, might decrease sexual desire     (libido). The goals of this study are to demonstrate that amantadine lowers prolactin levels,     decreases side effects, and improves psychiatric symptoms.   "
238277|NCT00975637|"     The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent     of improvement in PASI score at week 12.   "
238278|NCT00975650|"     This clinical trial is being performed to compare the pharmacokinetic profile of testosterone     after repeated intra-nasal administration of products of different strengths in subjects with     hypogonadism.   "
238279|NCT00975663|"     The purpose of this study is to evaluate in lung or heart-lung transplant patients on     tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug     monitoring and dose adjustment of both drugs on the incidence of treatment failure over the     first three years post-transplantation.   "
238280|NCT00975676|"     RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may     help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane     works in lowering estrogen levels.      PURPOSE: This clinical trial is studying estrogen levels in premenopausal women who have     undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or     exemestane on clinical trial IBCSG-2402.   "
238281|NCT00975689|"     Background:        -  Niemann-Pick disease type C (NPC) is a genetic disorder that results in progressive loss          of nervous system function by affecting the membranes of nerve cells. There is no known          cure for NPC.        -  N-acetyl cysteine (NAC) is a drug that has been approved by the Food and Drug          Administration to use either orally or IV for the treatment of acetaminophen (Tylenol)          poisoning or as an aerosol to reduce the stickiness of mucous in patients with cystic          fibrosis. In the body, NAC is converted to an amino acid called cysteine, which cells          can convert to a chemical called glutathione. Glutathione is important in helping cells          deal with oxidative stress. Based on a number of experiments in cells, mice and patients          with NPC, we believe that oxidative stress is increased in NPC. If we can increase          glutathione levels, we may be able to decrease the oxidative stress.      Objectives:      - To test the safety and effectiveness of N-acetyl cysteine to treat Niemann-Pick disease     (type C).      Eligibility:      - Individuals at least 1 year of age who have been diagnosed with NPC.      Design:        -  Patients entering this study will be seen at the National Institutes of Health Clinical          Center four times during the 20 weeks of the study. These admissions will occur at the          start of the study and at weeks 8, 12, and 20. The first NIH visit will last 2 days, and          the other visits will last 1 day.        -  Patients will participate in a two-stage study: a period of 8 weeks receiving NAC and a          second period of 8 weeks when receiving a placebo (a pill without NAC). Every patient          participating in this study will receive NAC during one of the two time periods.        -  The two treatment periods will be separated by a wash-out period, 4 weeks when patients          will receive neither NAC nor placebo. Patients will also have a 4-week wash-out period          at the beginning of the study. Most physician-prescribed medications, such as seizure          medications, will be allowed.        -  During each visit, examinations, procedures, and tests will be done, including blood and          urine samples.   "
238312|NCT00976092|"     Randomized comparison of two different anticoagulation strategies: prasugrel plus bivalirudin     versus clopidogrel plus heparin in patients with acute myocardial infarction undergoing     emergency catheterization and coronary intervention.   "
238419|NCT00968851|"     This study is being conducted to determine the safety and effect on cognitive function of two     different doses of an investigational medication, EVP-6124, in individuals with schizophrenia     who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and     psychotic symptoms will be evaluated.   "
238282|NCT00975702|"     Does remote ischemic preconditioning (RIPC) induced by a brief period of occlusion of blood     flow to the lower extremity prior to organ recovery in deceased donors, improve short and     long term outcomes after transplantation of kidneys, livers and pancreas? To test this     hypothesis deceased organ donors will be randomized to receive either RIPC or No RIPC before     organ recovery. RIPC will be induced in the operating room after commencement of procurement     surgery. RIPC will be induced by tourniquet-induced occlusion of blood flow to the lower     extremity for 10 minutes in each side, for a total duration of 20 minutes. The remainder of     the organ recovery and organ preservation will be as per standard of practice. Recovered     livers, kidneys and pancreas will be transplanted into allocated recipients. Transplantation     and patient management after transplantation will be as per standard of practice.      Organ-specific function and cell injury parameters will be utilized to assess the early     postoperative outcomes of individual organs and recipients. Long term outcomes will be     assessed by graft and recipient survival.   "
238283|NCT00975715|"     This study is designed to provide short term efficacy and safety data of TRI476 in children     with inadequately-controlled partial seizures. Patients will be randomized into either drug     treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks.     The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.   "
238284|NCT00975728|"     The purpose of this study is to evaluate the antioxidant activity on skin photo induced     damage of a food supplement and its anti-age properties.   "
238285|NCT00975741|"     Mometasone furoate (MF) is a new potent synthetic corticosteroid. Internationally, MF is     administered by a breath-actuated DPI and supplied in multidose devices. Capsules to be     administered through a monodose device that would offer an alternative to MF DPI multidose     treatment in terms of cost-effectiveness were developed in Brazil. The aim of the present     non-inferiority clinical study was to evaluate both devices in terms of efficacy and safety.   "
238286|NCT00975754|"     The purpose of this study is to assess the deposition of budesonide to the lung after     inhalation with 5 different devices and to relate the findings to in vitro properties of     inhaled budesonide.   "
238287|NCT00975767|"     The main purpose of this study is to assess the safety profile of MGCD265 when administered     in combination with the marketed anticancer drugs erlotinib and docetaxel.   "
238288|NCT00975780|"     The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol     in preventing pneumonia among nursing home residents.   "
238289|NCT00975793|"     The ARISE RCT is a multi-centre, randomised, controlled trial of EGDT compared to standard     care in patients with severe sepsis presenting to the ED. The study will be conducted in     multiple sites with 1600 patients enrolled into the study.      Hypothesis to be tested: EGDT, compared to standard Australasian resuscitation practice,     reduces 90-day all-cause mortality in patients presenting to the ED with severe sepsis.   "
238290|NCT00975806|"     The purpose of this study was to determine the maximum tolerated dose, safety, and     effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as     treatment for patients with renal cell carcinoma.   "
238291|NCT00975819|"     The purpose of this study is to determine if the use of sirolimus in the treatment of     children and young adults with complicated vascular anomalies will prove to be safe and     provide objective response resulting in improved clinical status and quality of life.      Funding Source - FDA OOPD (Food and Drug Administration - Office of Orphan Products     Development)   "
238292|NCT00975832|"     Inflammation may play a role in the development of polycystic ovary syndrome (PCOS). In this     study, the investigators investigated the expression of different mediators of inflammation     in fatty tissue and in blood in women with and without PCOS.   "
238293|NCT00975845|"     To compare the outcome of Anterior Cruciate Ligament (ACL) reconstruction performed using the     tibialis allograft to historical outcomes of ACL reconstruction patients and to establish if     any correlation exists between the age of the graft donor and the clinical outcomes.   "
238294|NCT00975858|"     The randomized comparison of two strategies in coronary revascularization: bypass surgery     without the use of a heart lung machine and coronary stenting procedure.      The comparison comprised the occurrence of cardiac adverse events after the procedure. In     addition, costs, cognitive outcomes and angiography were assessed.   "
238295|NCT00975871|"     Livedo vasculitis is disease with recurrent courses of painful foot or ankle ulcerations,     followed by healed white scars. The actual mechanism of its pathophysiology is not yet clear.     It has been reported to be associated with some gene mutations, for example, factor V Leiden     gene. This study is aimed to find the possible relation of these gene mutations in Taiwanese     patients.   "
238296|NCT00975884|"     The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'     investigational vaccine GSK2340272A.   "
238297|NCT00975897|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors select the best treatment for patients and predict their     response to treatment.      PURPOSE: This randomized phase II/III trial is studying how well tumor tissue testing works     in selecting treatment for patients with metastatic or locally advanced colorectal cancer.   "
238298|NCT00975910|"     The purpose of this study is to investigate the effect of lidocaine in antiarrhythmic dosage     on postoperative cognitive dysfunction in supratentorial craniotomy.   "
238313|NCT00976105|"     The overall purpose of this study is to see whether the drug is safe and well tolerated when     given to overweight or obese but otherwise healthy volunteers for 10 days. Up to 4 groups of     people will be given the drug at variable strengths. The blood levels of the drug will be     measured and the effects on mood and cognition (the mental processes involved in awareness,     learning and judgement) will be assesed.   "
238314|NCT00976118|"     This phase 2 study was designed to evaluate the activity of oral masitinib (AB1010)     administered at 2 dose levels during 24 weeks to patients with mild to moderate confirmed     Alzheimer's type disease.   "
238315|NCT00976131|"     This research study hopes to examine the effects of Coenzyme Q10 on doxorubicin (Adriamycin)     metabolism during breast cancer treatment.   "
240479|NCT01004237|"     The investigators hypothesize that pravastatin combined with valsartan may have additive     effects in hypertensive, hypercholesterolemic patients.   "
238299|NCT00975923|"     One group of hospitals participated in a collaborative approach for healthcare quality     improvement while another group was provided only a tool kit. The investigators' objective     was to determine if the Collaborative would perform better at preventing central     line-associated bloodstream infections (CLABSI) and ventilator-associated pneumonias (VAP).     Hospitals were randomized to the Tool Kit or Collaborative conditions. The investigators'     study evaluated the effects on care processes and outcomes of a multi-institutional quality     improvement initiative focused on preventing hospital associate infections. The     investigators' hypothesis was that the strategies for implementing safe critical care     practice will differ in level of achievement whereby the Collaborative group will perform     better than the Tool Kit group. The outcome measure comprised clinical event rates and an     index of safe practices that represent a bundling of key process measures related to     evidence-based practices for preventing catheter-related blood-stream infections and     ventilator-associated pneumonia in the intensive care unit.   "
238300|NCT00975936|"     This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction     (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well     as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in     healthy adult subjects. This will be an open-label fixed-sequence 2-period study in healthy     male volunteers after oral administration of [14C]-GSK706769 alone and in the presence of     Ketoconazole.   "
238301|NCT00975949|"     The purpose of this study is to compare the neurodevelopmental outcome and quality of life     between the fluconazole-treated and the placebo-treated patients that were enrolled in a     fluconazole prophylaxis study that occurred in the investigators' neonatal intensive care     unit (NICU) between 1998-2000.   "
238302|NCT00975962|"     This study is a blinded randomized study. Randomization for treatment/not treatment with     remote perconditioning takes place during transportation to the hospital. This is because the     investigators' hypothesis states that remote perconditioning is neuro-protective and the     effect is proportionally larger with early treatment. As the size of the effect is unknown,     the investigators will use multiple magnetic resonance imaging (MRI) scans to determine the     size of a potential neuro-protective effect.      The aims of this study are:        1. To describe method of remote perconditioning in clinical practice regarding feasibility.          Pros and cons and potential limitations.        2. To estimate the size of the effect of remote perconditioning in combination with          recombinant tissue plasminogen activator (rtPa) treatment within four and a half hours          of onset of symptoms.   "
238303|NCT00975975|"     The purpose of this study is to compare the effects (good and bad) of the medication     basiliximab in combination with cyclosporine (investigational therapy) for the prevention of     a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD     is a complication in which the cells of the transplanted bone marrow react against organs and     tissues.   "
238304|NCT00975988|"     Non-interventional, open-label, single group, multicentric post-marketing surveillance to     monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients     according to the prescribing information TYKERB® is a registered trademark of the     GlaxoSmithKline group of companies.   "
238305|NCT00976001|"     This is a randomized follow-up study after discharge from a stroke unit after a first stroke.     The patients are randomized either to follow-up at a special out-patient stroke unit or with     their general practitioners. The hypothesis is that follow-up with specialists is superior to     follow-up with general practitioners. Endpoints are mortality, recurrent stroke and handicap     measured with different scales.   "
238306|NCT00976014|"     This observational study looks at Carotid Stenosis in two groups of subjects using a     non-invasive procedure, B-mode ultrasound.      One group of subjects has had long-term intensive lipid altering therapy (lowering LDL-C plus     raising HDL-C). The second group of patients has been on conventional standard of care     treatment for carotid stenosis.      The study will look at the Carotid Intima-media Thickness (CMIT) in both groups.      Hypothesis: CIMT will differ between the two groups, such that the CIMT will be less in the     subjects on intensive lipid altering therapy.   "
238307|NCT00976027|"     The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of     Fluzone® vaccine in the elderly.      Primary objective:      To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed     influenza caused by viral types/subtypes that are antigenically similar to those contained in     the respective annual vaccine formulations.      Secondary objectives:        -  To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone®          vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused          by any type or subtype of influenza virus.        -  To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone®          vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by          viral types/subtypes antigenically similar to those contained in the respective annual          vaccine formulations.   "
238308|NCT00976040|"     The goal of this randomized clinical trial is to compare early versus standard timing of     initiation of antiretroviral therapy (ART) with respect to clearance of Cryptococcus     neoformans from cerebrospinal fluid (CSF) among HIV-infected adults with Cryptococcal     Meningitis.      The investigators hypothesize that early ART mediates more rapid clearance of C. neoformans     from CSF, as manifested by a greater rate of decrease in C. neoformans colony forming units     (CFUs) during the first 28 days after initiating antifungal treatment.      Secondary hypotheses are that recovery of pathogen specific cellular immunity directed at C.     neoformans, as manifested by increases in the number and function of C. neoformans-specific     peripheral blood mononuclear cells is associated with 1) ART and 2) pathogen clearance. In     addition, patients randomized to the intervention arm will have more rapid clearance of     antigen levels in CSF and serum and will have a lower incidence of grade 3 and 4 Adverse     events.   "
238309|NCT00976053|"     The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with     pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head     comparison in the same patient. The investigators hypothesize that pharmacologic stress     myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion     SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery     disease (CAD) who present with symptoms consistent with possible worsening of their CAD.   "
238316|NCT00976144|"     GW642444 is a potent and selective long-acting beta2 agonist; GSK573719 is a long-acting,     inhaled, muscarinic receptor antagonist (or anticholinergic) bronchodilator. Both are in     development as once daily (QD) monotherapies for the treatment of Chronic Obstructive     Pulmonary Disease (COPD). Development of these two inhaled drugs as a combination therapy is     also planned and would have potential for improved efficacy and patient benefit as they both     work through different receptor pathways and the combined bronchodilatory effect might be     additive.      This study is a randomised, double blind, placebo-controlled, four-way crossover study which     will assess the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of     GSK573719 and GW642444 in sixteen healthy Japanese subjects. Subjects will receive four     possible treatments as single inhaled doses, receiving the two monotherapies separately, the     monotherapies concurrently, and placebo.      Blood samples for PK analysis will be taken at regular intervals after dosing. Safety will be     assessed by measurement of heart rate, blood pressure, ECG and twenty-four hour Holter     monitoring, potassium, safety laboratory data and review of adverse events.   "
238317|NCT00976157|"     Triggering receptor expressed on myeloid cells (TREM)-1 is a recently described molecule that     plays an important role in myeloid cell-activated inflammatory responses. The aim of this     study was to investigate the evolutional change of soluble TREM-1 (sTREM-1) in     bronchoalveolar lavage (BAL) fluid of clinically diagnosed ventilator-associated pneumonia     (VAP) and its correlation with response to treatment and outcome.   "
238318|NCT00976170|"     This phase I trial is studying the safety and best dose of GC33 and Sorafenib in combination     in patients with advanced or metastatic liver cancer.   "
238319|NCT00976183|"     Since the mortality rates for patients with advanced ovarian carinoma are high, the most     likely way to improve progression free and overall survival is with maximal upfront therapy     (Morrow & Curtin, 1998). Currently, no triplet regimen has demonstrated compelling     superiority. Therefore, the combination of Paclitaxel, Carboplatin, and Vorinostat is     intriguing because of their potential synergy, distinct mechanisms of action, and     non-overlapping toxicity.   "
238320|NCT00976196|"     The PHP study aims to delineate gene products involved in high on-treatment platelet     reactivity in aspirin-treated cardiovascular patients.   "
238321|NCT00976209|"     This is a randomized, two-way crossover, multicenter study evaluating the consumer preference     of Phenylephrine Extended Release Tablets, 30 mg to be taken as one tablet every 12 hours, or     Phenylephrine Immediate Release Tablets, 10 mg to be taken as one tablet every 4 hours in     subjects with at least mild allergic rhinitis and nasal congestion. Approximately 250     participants will complete a questionnaire after taking one test product for 3 days followed     by a 3 day (± 1 day) washout period; and then taking the alternate test product for 3 days.     Analysis of which product the consumer preferred, if any, and which product was more     convenient, if any, will be evaluated.   "
238322|NCT00976222|"     The purpose of this study is to demonstrate the efficacy of ranibizumab in patients with     retinal pigment epithelial detachment secondary to age-related macular degeneration (AMD).   "
238323|NCT00976235|"     This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by     Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope     prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to     monitor long-term safety. Patients will undergo examinations at six-month intervals up to a     total of 5 years following implantation.   "
238324|NCT00976248|"     The purpose of this research study is to determine the safety of RAD001(Everolimus) and the     highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug     that works by preventing cells in the body from growing and dividing. Information from basic     and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor     growth in people with relapsed or refractory lymphoma.   "
238325|NCT00976261|"     The purpose of Part A of this study is to test whether repeated doses of the study drug     (GSK1614235) are safe and well tolerated (i.e. do not produce unacceptable side effects) and     whether we can obtain some preliminary information as to whether it works in lowering blood     glucose levels. We will do this by comparing the effect of the study drug with placebo (no     drug present) and against a drug (sitagliptin) known to control blood glucose in the     treatment of diabetes.      The purpose of Part B of this study is to determine the how the timing of dosing, relative to     meals, affects the response to study drug.   "
238326|NCT00976274|"     Five factor consisting of Metabolic syndrome is closely linked by insulin resistance. Until     now, several studies have been performed about effects of Korea red ginseng on hypertension,     diabetes, and hyperlipidemia, but not metabolic syndrome.      The investigators hypothesize that Korean red ginseng could improve each constituents of     metabolic syndrome, arterial stiffness, and inflammatory markers.      The aim of this study is to determine effects of Korean red ginseng on cardiovascular risks     in subjects with metabolic syndrome.   "
238327|NCT00976287|"     The purpose of this study is to investigate the efficacy of autologous bone marrow     mesenchymal stem cells (MSCs) transplantation via hepatic artery in the treatment of liver     cirrhosis. Liver function was monitored by serum examination. The levels of serum alanine     aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) and albumin (ALB) were     examined at pre-transplantation, and 3 days to 2 years post-transplantation. Child-Pugh     scores and clinical symptoms were also observed simultaneously.   "
238328|NCT00976300|"     Intravenous cyclophosphamide is considered to be the standard of care for treatment of     proliferative lupus nephritis. However, its use is limited by potentially severe toxic     effects. Cyclosporine A has been suggested to be an efficient and safe treatment alternative     to cyclophosphamide. In a randomized, multicenter, open-label, controlled trial the     investigators sought to compare the efficacy of oral cyclosporine A with intravenous pulse     cyclophosphamide to induce durable remission in patients with lupus nephritis III-IV.   "
238329|NCT00976313|"     Under the influence of epidural analgesia, patients may not feel the urge to urinate, which     can result in urinary retention and bladder overdistension.      The use of a transurethral catheter is associated with significant morbidity such as patient     discomfort, urinary tract infections, urethral trauma and stricture.      Urodynamic changes under thoracic epidural anaesthesia are still unknown. The aim of this     study is to compare lower urinary tract function before and during thoracic epidural     analgesia within segments T2 to T10 for postoperative pain treatment in patients undergoing     thoracotomy or sternotomy.   "
238331|NCT00976339|"     This proposal is for a pilot study of 20 premenopausal women at high risk for breast cancer     development who will receive high dose vitamin D3, cholecalciferol 20,000 IU (2 capsules)     weekly, for 1 year. The primary objective of this study is to determine the feasibility of a     1-year intervention of vitamin D in this study population. Secondary objectives include     evaluating the biologic effects of vitamin D.   "
238332|NCT00976352|"     Pompe disease is an inherited condition of acid alpha-glucosidase (GAA) deficiency resulting     in lysosomal accumulation of glycogen in all tissues. Glycogen accumulation leads to muscle     dysfunction and profound muscle weakness. A wide spectrum of disease is characteristic and     the most severe patients have cardiorespiratory failure, often fatal in the first two years     of life. Researchers have developed a way to introduce the normal GAA gene into muscle cells     with the expectation that the GAA protein will be produced at levels sufficient to reduce     glycogen accumulation. This study will evaluate the safety of the experimental gene transfer     procedure in individuals with GAA deficiency. The study will also determine what dose may be     required to achieve improvement in measures of respiratory function.   "
238333|NCT00976365|"     The purpose of this study is to obtain evidence from test article with efficacy in Metastatic     Breast Cancer patients. The average of all changes from baseline to post-treatment     evaluations in global health/quality of life (QoL) subscale assessed by self-administered     European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -     Core 30 (EORTC-QLQ-C30).   "
238334|NCT00976378|"     This is the first time NOX-A12 will be administered to man. The principal aim of this study     is to obtain safety and tolerability data when NOX-A12 is administered by single intravenous     (IV) doses to healthy male and female subjects. This information, together with the     pharmacokinetic and pharmacodynamic data, will help establish the doses and dosage regimen of     administration suitable for subsequent studies in the patient population.   "
238335|NCT00976391|"     This study will examine the safety and efficacy of albiglutide in combination with insulin     glargine as compared with the combination of insulin glargine and preprandial lispro insulin     in subjects with type 2 diabetes.   "
238336|NCT00976404|"     The objective of this study is to discover a new approach in which human immunodeficiency     virus (HIV) can be eradicated from an infected individual by intensified antiretroviral     treatment coupled with immunomodulation. The hypothesis is that eradication is possible only     if very potent antiretroviral drugs are delivered in conjunction with an immunomodulatory     agent that simultaneously attack the viral reservoirs.   "
238337|NCT00976417|"     It is known that a significant proportion of patients with heart failure have sleep     disordered breathing (SDB). Some of these patients will have Central Sleep Apnoea which is     one form of SDB. The SERVE-HF study aims to look at the effect of a breathing support     machine, or ventilator called Adaptive Servo-ventilation (ASV) on mortality in heart failure     patients with central sleep apnoea. In this related sub-study the investigators want to look     at how the ASV machine has its effect. The investigators will be carrying out tests in the     laboratory to measure various aspects of the way that breathing is controlled to measure the     effect that ASV has on patients.      In addition measurements looking at activity levels will be made using an actiwatch device     worn by patients for 14 consecutive days and nights.      Healthy controls will be recruited to all parts of this protocol (ie measurements at baseline     and 3 months) to allow comparison of data between patients and controls.   "
238338|NCT00976430|"     This study is intended to look at the safety and efficacy of the use of autologous bone     marrow derived stem cell transplant in patients with advanced Parkinson's disease.   "
238339|NCT00976443|"     Obesity is an important public health problem in the United States. The investigators     hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an     endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation,     and reduction in body weight. This protocol is designed to study the effects and safety of     gastric BTA injections. Subjects are randomized to receive placebo or one of two different     doses of BTA injected into the stomach during one endoscopy, performed via the mouth. Gastric     emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric     intake are recorded before and after injections, and subjects are seen in follow-up for 24     weeks.   "
238340|NCT00976456|"     Multi-center, open, randomized (parallel) and comparative phase III.      Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed     by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.      Arm A: Bevacizumab + pemetrexed      Arm B: Bevacizumab + pemetrexed + carboplatin   "
238341|NCT00976469|"     The purpose of this study is to determine the preferred dose of H1N1 pandemic influenza     vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of     immunogenicity and safety.   "
238342|NCT00976482|"     The study objective is to collect mid-term clinical outcome in a group of patients implanted     with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and     international environment.   "
238343|NCT00976495|"     The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as     assessed by glomerular filtration rate.   "
238344|NCT00976508|"     This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus     Pegvisomant for treatment of advanced solid tumors.   "
238345|NCT00976521|"     This is a multicenter, open-label, controlled, single-blind, randomized study with up to 452     subjects enrolled in up to 50 US and European sites. Subjects who present with anterior     ST-elevation myocardial infarction (STEMI) and an occluded proximal or mid left anterior     descending (LAD) with TIMI 0/1/2 flow will be eligible for randomization to one of the     following arms:        1. Local infusion of abciximab following thrombus aspiration        2. Local infusion of abciximab and no thrombus aspiration        3. No local infusion and thrombus aspiration        4. No local infusion and no thrombus aspiration      In addition, a cardiac magnetic resonance imaging (MRI) sub-study evaluating microvascular     obstruction (MVO) will be performed with up to 160 subjects at up to 20 sites.   "
238346|NCT00976534|"     The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in     patients with peripheral neuropathic pain. This will be done by comparing the effect of     AZD1386 to placebo (inactive substance) on pain.   "
238347|NCT00976547|"     Objective: To evaluate the correlation between audiometric thresholds, pitch matching (PM),     minimum masking level (MML), Tinnitus Handicap Inventory (THI) and the Beck Depression     Inventory (BDI) in tinnitus patients.      Subjects: 48 patients with tinnitus as the main complaint from OTOSUL, Otorrinolaringologia     Sul-Fluminense, Volta Redonda, RJ, Brasil and Centro de Tratamento e Pesquisa em Zumbido,     Belo Horizonte, MG, Brasil.      Method: Subjects performed tonal audiometry, Pitch Matching (PM) and Minimum Masking Level     (MML) for tinnitus. They also fulfilled the Tinnitus Handicap Inventory (THI) and Beck     Depression Inventory (BDI). Data was statistically compared for correlation between     audiometric thresholds, psycho-acoustic measures and questionnaires.   "
238348|NCT00976560|"     In this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive     design study, the antidepressant and plasma cytokine lowering effects of the GW856553 will be     investigated in adult subjects diagnosed with MDD. Subjects will receive oral doses of     GW856553 or placebo for six weeks. Safety, tolerability, pharmacokinetics and     pharmacodynamics, defined as biomarkers in blood and clinical symptoms, will be assessed.      The primary endpoint is the change from baseline associated with GW856553 versus placebo at     Week 6 in the Bech (6-item HAMD-17) score. Interim analyses of the primary endpoint will be     performed throughout the study to potentially adapt the study design by changing the     randomization ratio and/ or reducing the total number of subjects to be randomized into the     study. Exploratory analyses will be performed by associating changes in cytokine levels and     selected clinical symptoms; PK/PD modelling will also be used to identify the most sensitive     clinical and biological markers.   "
238349|NCT00976573|"     This randomized phase II trial is studying how well carboplatin, paclitaxel, and bevacizumab     work when given with or without everolimus in treating patients with malignant melanoma that     has spread from where it started to other places in the body. Drugs used in chemotherapy,     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     bevacizumab, may block the ability of tumor cells to grow and spread. Everolimus may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking     blood flow to the tumor. It is not yet known whether combination chemotherapy given together     with bevacizumab is more effective with or without everolimus in treating patients with     metastatic melanoma.   "
238350|NCT00976586|"     Incontinentia Pigmenti (IP) is an X-linked dominant ectodermal dysplastic disorder. It is due     to loss of function of NF-Kappa B Essential Modulator (NEMO, inhibitor of Kappa light     polypeptide gene enhancer in B cells, Kinase of Gamma, IKBKG), an important regulator of the     NF-kB pathway. Major clinical manifestations of IP include swirling skin pigmentary changes,     and anomalies in organs including the eyes, dental, bones, nervous system, and heart.     Affected male mostly die before birth. Older patients might have immunodeficiency,     psychomotor retardation, and seizures. Prenatal diagnosis is difficult. IKBKG gene is 35 kb     in length, and contains 10 exons. A pseudogene (∆NEMO, IKBKGP), located distal and in inverse     direction to the true gene, contains only exon 3-10. In patients with IP, the most common     mutation was exon 4-10 large deletion. But the investigators have found small mutations     derived from the pseudogene in Taiwanese patients.      The three aims of this study are the role of pseudogene in IP, the frequency of recombination     between IKBKG and IKBKGP, and possible treatment. To achieve the first aim, the investigators     first develop a pseudogene-specific polymerase chain reaction (PCR). The investigators will     first obtain the frequency of IKBKGP gene mutation in normal individuals. The investigators     will then detect IKBKGP related mutations in IP patients presenting classical or     non-classical symptoms. The latter group of patients, who may have isolated hair, teeth,     retinal, or immune problems, are more likely to be caused by point mutations. The second aim     of this study is to estimate the incidence of IKBKG and IKBKGP recombination. Because these     two genes are in opposite position, recombination after DNA loop back is likely to occur in     somatic cells. The investigators will transform lymphocytes containing IKBKGP mutation, and     culture them continuously. IKBKG mutation will be check intermittently and the incidence can     be estimated. The third aim is to find a treatment. The investigators will test the     read-through drug gentamycin and PTC2124 for nonsense mutation. Either fibroblast or     Epstein-Barr virus (EBV) - transformed lymphoblasts will be tested. The investigators hope     this study with not only increases our understand to IP, and also improves the investigators'     knowledge toward genetic diseases.   "
238351|NCT00976599|"     To explore the effect of CP-690,550 on blood and synovial markers in subjects with rheumatoid     arthritis. To evaluate the safety, tolerability and efficacy of CP-690,550.   "
238352|NCT00976612|"     In patients who are receiving nilotinib, nilotinib plasma levels will be measured after 1     month of nilotinib treatment. The relationship between surgery type and nilotinib     pharmakokinetic properties will be investigated in this study.   "
238353|NCT00976625|"     Follow-up study in patients with severe aortic regurgitation after successful valve     replacement. Systolic and diastolic function were assessed and persistent diastolic     dysfunction was observed late (7-10 years) after operation.   "
238354|NCT00976638|"     Colonization of patients with Antimicrobial Resistant Bacteria (AMRB) like Methicillin     Resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and     Extended-Spectrum Beta-Lactamases (ESBL) enterobacteriaceae leads to infections; and     ultimately to adverse outcomes (eg prolonged hospital stay, death). This is an urgent problem     in Europe, especially in Intensive Care Units (ICUs).      In this trial, colonization of patients with these AMRB will be assessed in the baseline     period (6m). In phase 2 the effect of a Hygiene Improvement Program, including Chlorhexidine     body washings and a Hand Hygiene training program, will be assessed (6m). In phase 3 units     will be randomized to either Active Surveillance with Chromagar based tests or a Molecular     based tests.      Study Hypothesis: the abovementioned interventions will reduce ICU-acquired colonization     rates with MRSA, VRE and ESBL.   "
238355|NCT00976651|"     The purpose of the present study is to assess the influence of the administration of low dose     hCG on the endometrium. The study is a randomised trial where 2 groups of patients,     undergoing a gonadotropin-releasing hormone antagonist protocol for in vitro fertilization,     are studied. In addition to the histological findings, by analysing the correlation of the     morphological pattern and gene expression profile of human endometrium on the day of oocyte     retrieval in patients of both treatment groups, the investigators want to study the     implantation potential.   "
238356|NCT00976664|"     The purpose of this research study is to determine the change in perceived levels of pain and     dysfunction in 50 patients with chronic low back pain, following the use of custom-made shoe     orthotics for a three month period. The hypothesis of this study is that custom orthotic     intervention will improve the patients' low back pain and dysfunction symptoms.   "
238449|NCT00969241|"     This study will examine the relationship between free radicals in the saliva and     periodontitis. 30 adults, 15 with periodontitis and 15 as a control group will give a sample     of saliva before treatment and after treatment. The investigators will examine the free     radicals in both groups.   "
238357|NCT00976677|"     This randomized phase II trial studies how well carboplatin, paclitaxel, and bevacizumab work     with or without erlotinib hydrochloride in treating non-smokers with advanced non-small cell     lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Erlotinib hydrochloride     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and     by blocking blood flow to the tumor. It is not yet known whether giving combination     chemotherapy together with bevacizumab is more effective with or without erlotinib     hydrochloride in treating patients with non-small cell lung cancer.   "
238358|NCT00976690|"     To show the superiority of Azathioprine comparing Mesalazine in the prevention of     postoperative recurrence in Crohn's Disease.   "
238359|NCT00976703|"     This study aims to determine what type of traction, weighted bag or inner thigh taping, on     foley catheters for cervical ripening results in a greater cervical dilation and shorter     length of labor.      The primary outcomes are post-ripening dilation of 3 cm or more and time to delivery.      The secondary outcomes are patient pain/comfort rating and method of delivery. The     investigators hypothesize that the use a weighted bag will result in a 20% increase in     post-ripening dilation of at least 3 cm and a shorter average length of labor.   "
238360|NCT00976716|"     To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic     pain for the duration of 8 days.   "
238361|NCT00976729|"     This is the first time NOX-E36 will be administered to man. The principal aim of this study     is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous     (IV) and subcutaneous (SC) doses to healthy male and female subjects. This information,     together with the pharmacokinetic and pharmacodynamic data, will help establish the doses,     dosage regimen and route of administration suitable for multiple dose administration to     healthy volunteers, followed by the studies in the patient population.   "
238362|NCT00976742|"     The investigators hypothesize that the degree to which older generally healthy but sedentary     men and women improve a number of cardiovascular (CV) disease risk factors with 6 months of     highly-standardized endurance exercise training will be a function of common genetic     variations in candidate genes.   "
238363|NCT00976755|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying the side effects of everolimus and to see how well     it works as first-line therapy in treating patients with prostate cancer.   "
238364|NCT00976768|"     The purpose of this study is:        -  To observe the feasibility of biweekly oxaliplatin and infusional 5-fluorouracil          (FU)/Leucovorin (LV) in patients with advanced gastric adenocarcinoma who have prior          exposure to taxane, fluoropyrimidine, and cisplatin        -  To determine the activity of this combination regimen.        -  To evaluate the treatment-related toxicities.   "
238365|NCT00976781|"     The purpose of this study is to identify the gaps in diagnosing and managing hepatitis C     infected patients so that interventions can be targeted to address these problem areas in     order to optimize care of these patients.   "
238366|NCT00976794|"     The purpose of this study is to determine the efficacy of the combination of lithium and     carbamazepine compared with lithium and valproate treating young bipolar patients.   "
238367|NCT00976807|"     The principal research question to be answered by this study is whether an exercise based     rehabilitative intervention following critical illness can generate improvements in exercise     capacity and quality of life beyond current (usual) care. The investigators will also aim to     demonstrate that such an intervention is both practical and cost-effective.   "
238368|NCT00976820|"     The purpose of this study is to characterize the safety and immune response of the H1N1     (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of     age.      This Protocol Posting has been updated following the Protocol amendment 1 & 2, September and     October 2009. The sections impacted are study design, objectives and analysis methods.   "
238369|NCT00976833|"     Acute Respiratory Failure (ARF) requiring mechanical ventilation affects 1.1 million of the     4.4 million people admitted to United States Intensive Care Units (ICU) every year. Patients     with ARF have an average ICU and hospital length of stay (LOS) of 8 and 15 days,     respectively, with median hospital costs greater than $30,000 United States. Patients with     ARF experience deconditioning, muscle weakness, joint contractures, dyspnea, depression, and     reduced health-related quality of life, all of which may contribute to prolonged     hospitalization and increased costs. Mechanistically, it is understood that patients with ARF     demonstrate acute inflammation which may contribute to the above cited problems. While the     investigators' research and that of others has shown that rehabilitation therapy can increase     functional outcomes while lowering biomarkers of inflammation in the frail aged and other     clinical populations, it is not known whether such rehabilitation therapy can result in     improved functional capacity and functional performance and reduce inflammation in ARF     patients. There is previous evidence for the feasibility and safety of rehabilitation therapy     in ARF patients. Therefore, the investigators propose a two-arm, randomized trial in 326     patients with ARF to compare Standardized Rehabilitation Therapy initiated in the ICU and     administered throughout the hospitalization versus usual care (control). Standardized     Rehabilitation Therapy will consist of: passive range of motion, physical therapy and     progressive resistance exercise (strength training). The regimen will be administered 7     days/week by a Mobility Team consisting of a critical care nurse, physical therapist and     nursing assistant.      The investigators will determine whether standardized rehabilitation therapy will reduce     hospital LOS, improve functional capacity and performance, improve quality of life, reduce     inflammation and reduce hospital costs as compared to usual care.      This study's primary objective is to determine whether standardized rehabilitation therapy     will decrease hospital length of stay.      Hypothesis: Compared to usual care, standardized rehabilitation therapy will reduce hospital     length of stay for patients with Acute Respiratory Failure.   "
238370|NCT00976846|"     The proposed study seeks to determine the appropriate balance between the removal of     undesirable small molecular substances (urea, creatinine, phosphate) and large molecular     substances (ß2-m) and the retention of important substances (e.g.albumin) for the Baxter     Xenium XPH dialyzer type under defined therapeutic conditions of olHDF primarily concerning     filtration flow rates in relation to blood flow/plasma water flow rates. Furthermore the     possibility of the removal of certain protein-bound substances shall be investigated together     with the impact of increasing ultrafiltration on the parameters of the micro-inflammation.   "
238371|NCT00976859|"     The purpose of this study is to determine whether a short term programme with internet     research on the frequency of skin exchange and guided imagery modification is effective in     the treatment of the feeling of being contaminated in female victims of childhood sexual     abuse (CSA).   "
238372|NCT00976872|"     Recent evidences showed beneficial effects of omega-3 fatty acids on cardiovascular morbidity     and mortality.      Regular Omega-3 fatty acid consumption reduces cardiovascular mortality, ischemic heart     disease and stroke mortality. There is probably no single mechanism of action that explains     this beneficial effect; but possible mechanisms include reduce susceptibility of the heart to     ventricular arrhythmia, antithrombogenic effect, reduce triglyceride level, promotion of     nitric oxide-induced endothelial relaxation, and retard growth of atherosclerotic plaque.      The combination of satins and omega3 was proved to be better the any of the drugs alone in     several studies.      The purpose of the study is to investigate several possible mechanisms that may explain the     add on beneficial effect of omega-3 in hypercholesterolemic patients already treated with     satins.   "
238373|NCT00976885|"     The aim of this study was to measure the oxygen consumption and peak heart rate achieved     during Modified Rivermead Mobility Index (MRMI) assessment in age-matched, healthy and stroke     patients, and assess the efficacy of the MRMI tasks for aerobic training in patients with     stroke.   "
238374|NCT00976898|"     In this study the investigators will be studying the effects of proton beam radiation     therapy. This is a very accurate kind of treatment that has been shown to affect less normal     tissue than a photon radiation beam. The accuracy allows the investigators to more safely     increase the amount of radiation delivered to eliminate cancer. This accuracy will     potentially reduce side effects that participants would normally experience using photon     radiation therapy. The purpose of this study is to determine if radiation using proton beam     therapy will kill the cancer cells in the participants liver.   "
238375|NCT00976911|"     This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin     added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian,     fallopian tube or primary peritoneal cancer with disease progression within 6 months of     platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or     topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive     Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on     study treatment is until disease progression. Patients will then receive standard of care,     those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target     sample size is 100-500 individuals.   "
238376|NCT00976924|"     Blood glucose test strips are tested with the test meters to test the accuracy of the blood     pressure monitoring function.   "
238377|NCT00976937|"     The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in     comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index     [BMI] greater than or equal to 30 kilogram per square meter [kg/m^2]) type 2 diabetic     patients less than 50 years of age, over a period of 24 weeks of treatment.      The primary objective of this study is to assess the efficacy of lixisenatide, in comparison     to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic     control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24.      Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin,     as an add-on treatment to metformin on absolute changes in HbA1c values and body weight;     fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin     during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model     assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model     assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and     anti-lixisenatide antibody development.   "
238378|NCT00976950|"     The aim of this trial is to evaluate the safety and virological and immunological efficacy of     Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed     resistance to more than one protease inhibitor.   "
238379|NCT00976963|"     Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting     approximately one-half of women by their late 20's. One of the most common antibiotics used     to treat UTIs is Trimethoprim-sulfa (TMP-SMX), usually for total of three days. However,     concerns about increased antibiotic resistance have led to increased interest in studying     other antibiotics for UTI.      An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin     (Monurol). The effectiveness of fosfomycin in curing UTIs when given as a single dose is not     well studied. The purpose of this research study is to determine what the cure rates are with     a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX.   "
238380|NCT00976976|"     Despite the improvement of surgical resection as primary curative treatment for gastric     cancer, more than 70% of patients with stage IIIB and IV disease undergoing radical primary     tumor resection relapse and die within 5 years. Therefore, there is an urgent need to further     improve the treatment for gastric cancer in this population. Recently reported phase III     study comparing capecitabine/cisplatin (XP) versus 5-FU/cisplatin (FP), XP showed better     activity and tolerability compared with FP. To improve treatment outcomes of XP chemotherapy,     the investigators performed a phase I-II study of docetaxel, capecitabine and cisplatin in     advanced gastric cancer (AGC). Phase I-II study of docetaxel, capecitabine and cisplatin as     first-line chemotherapy in advanced gastric cancer (Kang et al, Proc Am Soc Clin Oncol     22,328.2003). The docetaxel/capecitabine/cisplatin (DXP) chemotherapy was highly active for     the 1st-line chemotherapy of AGC. These findings and experience encourages the investigators     to design the adjuvant trial of DXP chemotherapy in patients with resected gastric cancer.     The aim of this study is to assess the efficacy and safety of adjuvant DXP in this patient     population.   "
238391|NCT00977119|"     The purpose of this study is to identify possible genetic polymorphisms that contribute to     specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and     neutropenia).      Additionally, this study will look at gene polymorphisms in patients experiencing the     toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.   "
238392|NCT00977132|"     As part of a palliative therapy concept, feasibility, toxicity, and effectiveness of     treatment with the combination of Valproic acid and lenalidomide in Myelodysplastic Syndrome     patients with a favorable risk profile will be investigated.   "
238393|NCT00977145|"     The goals of this study are to evaluate 1) the safety of administration of intratumoral     interferon gamma with a peptide-based vaccine, in patients with melanoma and 2) the     biological effects of the vaccine. These include an examination of changes within the tumor     following vaccination and the evaluation of T cell responses to the vaccine both in the blood     and at the sight of tumor.   "
238381|NCT00976989|"     This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment     regimens in participants with locally advanced, inflammatory or early stage human epidermal     growth factor receptor 2 (HER2)-positive breast cancer. Before surgery, participants will be     randomized to receive either A) 6 cycles of pertuzumab plus trastuzumab (Herceptin), with     5-fluorouracil/epirubicin/cyclophosphamide (FEC) for cycles 1-3 and docetaxel for cycles 4-6,     or B) FEC for cycles 1-3 followed by pertuzumab plus trastuzumab with docetaxel for cycles     4-6, or C) 6 cycles of pertuzumab plus trastuzumab with docetaxel and carboplatin. Pertuzumab     will be administered at a loading dose of 840 mg intravenously (iv), then 420 mg iv 3-weekly,     trastuzumab at a loading dose of 8 mg/kg iv, then 6 mg/kg iv 3-weekly, docetaxel at 75 mg/m^2     iv, increased to 100 mg/m^2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard     doses. Following surgery participants will receive trastuzumab 6 mg/kg iv 3-weekly for a     total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on     study treatment is 4-12 months, and target sample size is 200-300.   "
238382|NCT00977002|"     Child extubation failure range from 4.1% to 19%. Studies in adults and children showed that     extubation failure increases mortality mainly in those who need reintubation as this is a     invasive procedure associated with many complications. Therefore, patients are reintubated     when they worsen, which can contribute to organ dysfunction and increased mortality.      Positive Pressure Noninvasive ventilation (PPNIV) has been proposed as a way to treat acute     respiratory distress, avoiding complications of intubation and invasive ventilation. Most of     the studies in adults are not conclusive on the benefits of PPNIV as a way to treat     post-extubation acute respiratory distress. However, studies that evaluated the early use of     PPNIV in post-extubation period as a way to prevent respiratory failure tend to show some     advantages as decrease of reintubation, decrease number of respiratory distress, decrease of     hospital infection frequency and lower mortality rate in the intensive care unit (ICU) for     those who use PPNIV.      In a prospective study on the use of PPNIV in 114 children, Essouri at al avoided invasive     ventilation in 77%, being the group in patients with post-extubation respiratory distress.      As far as the investigators know there is not any randomized, controlled study in children     examining the PPNIV as a way to prevent post-extubation respiratory distress. The     investigators' hypothesis is that PPNIV decreases the extubation failure rate and, as a     consequence, the Pediatric Intensive Care Unit (PICU) and hospital length of stay, and     mortality rate.      The objective is to compare PPNIV and inhalatory O2 (catheter or facial mask) in children     after extubation, evaluating the need of reintubation, hospital and PICU mortality rate and     length of stay in PICU and hospital.   "
238383|NCT00977015|"     The purpose of this study is to investigate the time course of PF-04764793 concentration in     the blood following dosing by oral inhalation from dry powder inhalers.   "
238384|NCT00977028|"     This pharmacokinetic clinical trial is a dose ranging study of lidocaine in tumescent local     anesthesia. The goal is to understand the absorption pharmacokinetic of tumescent lidocaine     and to determine an objective (statistical) estimate of the maximum safe mg/kg dosage of     lidocaine in tumescent local anesthesia without liposuction.   "
238385|NCT00977041|"     A number of studies suggest that training to increase different types of brain waves is     related to pain relief. The purpose of the second phase of this study is to see if     neurofeedback training might help people with chronic pain control their pain better. The     information from the study may help the investigators treat chronic pain better in the     future.   "
238386|NCT00977054|"     Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma     (HCC) and liver transplantation, affects approximately 170 million individuals worldwide. The     prevention of HCV transmission and early intervention of HCV infection are urgently needed to     reduce or halt the liver-related morbidity and mortality. Double filtration plasmapheresis     (DFPP) has been with widespread use in clinical practice for several indications with plasma     filters optimized for the respective elimination targets with excellent safety. By way of the     plasma separator, the blood is separated into plasma and cell components. Separated plasma is     then led into the plasma component separator where the pores of the plasma component     separator further fractionate the plasma into large and small molecular components. The large     molecular components, including pathogenic substances, is removed and discarded and the small     molecular components, including proteins such as albumin and gamma-globulin, are returned to     the patient and mixed with the cell components. After the initiation of pegylated interferon     plus ribavirin (Peg-IFN+RBV) therapy, the rapid first phase relates to a significant     reduction in virus production and the degradation of free virus particles, which is followed     by a second much slower one reflecting the elimination and clearance of infected cells. In     HCV patients, high baseline viral load at the initiation of therapy is considered to be a     negative predictor for systemic vascular resistance (SVR) for HCV genotype 1 patients.     Reduction of baseline viral load by means of therapeutic double filtration plasmapheresis     (DFPP) may represent a plausible adjunct for improved antiviral therapy to reduce the virus     load with the initiation of treatment in synergy with Peg-IFN and RBV combination therapy.     Recently, several clinical studies in evaluating the therapeutic efficacy and safety of DFPP     in conjunction with IFN-based therapy were conducted for treatment-naïve genotype 1 high     viral load CHC patients, and CHC patients who underwent liver transplantation. These studies     showed that patients with DFPP treatment had more favorable HCV early viral kinetics to those     without DFPP treatment. Furthermore, all these studies showed excellent safety after DFPP     treatment. Therefore, the investigators aimed to conduct a large-scaled randomized controlled     trial to evaluate the overall response of DFPP for HCV genotype 1 patients with high viral     load.   "
238387|NCT00977067|"     The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be     determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.   "
238388|NCT00977080|"     Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin     D.   "
238389|NCT00977093|"     The purpose of this study is to determine how well perfusion cardiac magnetic resonance (MR)     imaging is able to detect certain heart abnormalities, such as a coronary artery narrowing.      To this purpose, a conventional MR contrast medium (Gd-DTPA-BMA) will be used during an     adenosine infusion (an approved substance which enlarges the arteries of the heart, so that     the blood flow to the heart muscle increases). This magnetic resonance imaging technique will     be compared with single photon emission computed tomography (SPECT), a well-established     technique to detect this heart abnormalities.      Both, cardiac MR and SPECT will be compared with invasive coronary angiography, a technique     which directly visualized the heart vessels and narrowings of these (=standard of reference).   "
238390|NCT00977106|"     This study will assess the onset and maintenance of effect of tocilizumab on relief in     patients with active moderate or severe rheumatoid arthritis who have had an inadequate     response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will     be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4     weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every     4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target     sample size is >100.   "
238394|NCT00977158|"     The goal of this study is characterize the changes in bacterial diversity of the upper     respiratory tracts of infants with cystic fibrosis (CF). Another goal is to determine when CF     patients become colonized with pathogenic bacteria that are responsible for the lethal lung     damage in children with CF. Ten subjects will be recruited into the study. Throat swabs will     be collected at 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age in order     to chart any changes in the bacterial populations of the respiratory tract. Clinical data     will also be collected to evaluate the possible influence of external factors on changes in     the microbial communities. This study will provide preliminary data on whether probiotics can     eradicate the colonization of the respiratory tract by pathogenic bacteria.   "
238395|NCT00977171|"     A subset of patients suffering from chronic fatigue syndrome exhibit symptoms of neurally     mediated hypotension. While the underlying pathophysiology of chronic fatigue syndrome is not     precisely understood, a dysfunction of the autonomic nervous system is thought to play a role     in this subset of patients. In several small studies, subjects within this subset have noted     improvement in their chronic fatigue symptoms when treated for their neurally mediated     hypotension. As droxidopa acts on the autonomic nervous system and has been shown to     ameliorate symptoms of neurally mediated hypotension, it is hypothesized that droxidopa could     aid in the treatment of chronic fatigue symptoms.      Neurally mediated hypotension has been associated with patients suffering from chronic     fatigue syndrome. Droxidopa meanwhile has been approved in Japan for the treatment of the     symptoms of neurogenic orthostatic hypotension. As such, it is hypothesized that regulating     the autonomic nervous system in patients with Chronic fatigue syndrome may prove to be     clinically beneficial.   "
238396|NCT00977184|"     Background:        -  In transcranial magnetic stimulation (TMS), a device creates a short-lasting magnetic          field which induces an electric current in the brain leading to a change in the activity          of brain cells. There are different effects on the brain with different rates of          stimulation. In a previous study in people with Parkinson's disease, repetitive TMS          (rTMS) given at a particular rate temporarily improved their ability to walk. A faster          rate of rTMS may be more effective in treating symptoms than the rate originally used.        -  This study will compare active rTMS to inactive (sham or Placebo) rTMS. Half of the          people in this study will have active rTMS; the other half will have no brain          stimulation with rTMS.      Objectives:      - To see if a faster rate of transcranial magnetic stimulation is a more effective treatment     for the symptoms of Parkinson's disease than the slower rates that have been studied.      Eligibility:        -  Individuals between 40 and 80 years of age who have been diagnosed with mild or moderate          Parkinson's disease.        -  Participants must currently be taking Sinemet or dopamine agonists drugs (e.g.,          bromocriptine, cabergoline, pergolide, pramipexole, ropinirole, apomorophine, and          rotigotine), and are willing to continue their same treatments for the duration of the          study.      Design:        -  This study requires 11 outpatient visits to the NIH Clinical Center over 6 weeks.          Participants can also be admitted and stay as an inpatient in the NIH Clinical Center          for the entire study period (for the 10 visits during the first weeks and the follow-up          visit a month later).        -  Initial visit will consist of a physical examination; a test of participants' time to          walk 10 meters; and questions about memory, mood, and quality of life. Participants          should not take Parkinson's disease medications for 12 hours before this visit; once the          examinations and tests are complete, participants will be able to take the medications.          Researchers will repeat the tests 1 hour after participants take the medication.        -  TMS sessions: 8 TMS sessions (4 sessions per week) over 2 weeks. Each stimulation          session will last half an hour. Half of the participants will receive active TMS; the          other half will receive sham TMS.        -  The first 10 participants will have additional tests to study the safety of rapid TMS in          patients with Parkinson's disease.        -  A day after completing the last TMS session, participants will repeat the same tests as          the first visit before and after taking their medication as in the first assessment and          respond to questions about mood, memory, and quality of life.        -  One month after completing the last TMS session, participants will repeat the same tests          as the first visit before and after taking their medication.   "
238397|NCT00977197|"     This study is being done to see if Lyrica helps people with irritable bowel syndrome.   "
238398|NCT00977210|"     The purpose of this study is to establish the Maximum Tolerated Dose (MTD) of OXi4503 given     by weekly infusions to patients with advanced solid tumors.   "
238399|NCT00977223|"     Data from the literature and previous in vitro research conducted in the investigators'     laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid     secretion might be controlled by sympathetic nervous system. This neurocrine regulation of     corticosteroid secretion involves locally released neuropeptides. Among them, substance P is     able to stimulate aldosterone and cortisol production via NK1 receptors.      The aim of the present study is to investigate the effects of a NK1 receptor antagonist,     aprepitant, on adrenocortical secretions in healthy volunteers. Aprepitant is a drug already     available for the treatment of nausea induced by chemotherapy.      In the present phase IV trial, plasma aldosterone and cortisol levels will be measured under     treatment with aprepitant versus placebo, in both basal conditions and after activation of     the adrenocortical function by various stimuli, including upright posture, metoclopramide,     and insulin-induced hypoglycaemia. All healthy volunteers will be given the two substances     (aprepitant and placebo) in a random order during two one-week periods separated by a 14     day-wash-out.      This study should allow to determine the role of substance P in the control of corticosteroid     production in normal man.   "
238400|NCT00977236|"     The purpose of this study is to evaluate and compare the eyeball elongation in high myopic     children using partial correction orthokeratology and single-vision spectacles.   "
238401|NCT00977249|"     Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?      Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal     dreams.   "
238402|NCT00977262|"     The main objective is to elucidate the acute effects of an oral intake of either saturated,     monounsaturated or polyunsaturated fatty acids on peripheral blood mononuclear cells (PBMC)     whole genome expression of obese and type 2 diabetic obese subjects.   "
238403|NCT00977275|"     The purpose of this study is to evaluate radiation therapy directed to a small region of the     breast in women who were recently diagnosed with early stage invasive breast cancer.   "
238404|NCT00977288|"     This study will investigate the effect of MK0859 when administered alone and when in     combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in     Japanese patients with dyslipidemia.   "
238405|NCT00977301|"     The effect of fosamprenavir/ritonavir (steady state) on the pharmacokinetics of a single dose     of olanzapine will be studied.      In this study, the investigators expect an inducible effect of fosamprenavir/ritonavir on the     CYP1A2 and UGT metabolism of olanzapine.   "
238406|NCT00977314|"     The purpose of this study is to determine the safety and efficacy of using bone conduction     via the teeth to treat Single-Sided Deafness (SSD).   "
238407|NCT00968695|"     Pharmacodynamic study of pathophysiological nature to assess the effects of prolonged     administration of human albumin in the cardiocirculatory and renal function and hepatic     hemodynamics in patients with advanced cirrhosis and ascites.   "
238408|NCT00968708|"     The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once     daily (QD), compared with placebo, in addition to standard of care, in patients with type 2     diabetes mellitus and acute coronary syndrome.   "
238409|NCT00968721|"     The primary purpose of this study is to pilot test an instrument that the investigators will     develop to assess decision influences on inflammatory bowel disease patients' medication     adherence decision-making.      This pilot study will use an exploratory, descriptive cross-sectional survey approach to     pilot test the instrument and answer the research questions.      The main hypothesis is that patients at risk for intentionally modifying their prescribed     medication regimen will differ on influences on decision-making, health status, and     utilization of the IBD clinic services compared to those who are intentionally adherent and     who continue adherence over time.   "
238410|NCT00968734|"     The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3     (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal     associated with the administration of the supplement.   "
238411|NCT00968747|"     The purpose of this study is to examine how acute nutritional challenges affect levels of     several proteins involved in metabolism. These proteins will be measured in blood and fat     tissue.      This study will have several aims.      One aim is to examine the effect of 72 hours of fasting on fibroblast growth factor-21     (FGF-21) levels. Participants will spend 3 days and nights in the Clinical Research Center at     the Beth Israel Deaconess Medical Center in Boston, MA. Daily blood samples will be taken.     Two fat samples will be taken prior to and at the end of the fast. A subset of participants     will also have two MRIs, one prior to and one at the end of the fast. We will study healthy     adults and obese adults with liver-biopsy-diagnosed non-alcoholic fatty liver disease     (NAFLD). THIS STUDY ARM IS CURRENTLY NOT RECRUITING      Another aim is to examine the effect of low-calorie diet on FGF-21 levels. Subjects will     follow a hypocaloric diet that will be designed to achieve 3-5% weight loss. We will enroll     participants with liver-biopsy-diagnosed non-alcoholic fatty liver disease. Participants will     report weekly to the Clinical Research Center at Beth Israel Deaconess Medical Center for     weight measurements. Blood will be drawn before and after the weight loss. Participants will     also have an MRI before and after the weight loss.      THIS ARM IS CURRENTLY NOT RECRUITING      Another aim of the study is to examine the effect of acute ingestion of glucose, fructose,     and other sugars on serum FGF21 levels. Subjects in this study will be lean volunteers and     individuals with metabolic syndrome.      THIS ARM IS CURRENTLY RECRUITING   "
238412|NCT00968760|"     Sometimes researchers change the DNA (genetic material in cells) of donated T cells (white     blood cells that support the immune system) using a process called gene transfer. Gene     transfer involves drawing blood from the patient, and then separating out the T-cells using a     machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject     the changed T-cells into the body of the patient.      The goal of this clinical research study is to learn if an investigational type of gene     transfer can be given reliably and safely in patients with advanced B-cell lymphoma. B cells     are a type of white blood cell that fights infection and disease. Lymphoma is a type of     cancer that affects the immune system, including B cells.      The gene transfer involves drawing blood, separating out T cells (white blood cells that     fight infection and disease), changing the T cells' DNA (genetic material) in a specific way,     and returning the changed T cells back to the body.      Researchers want to learn the highest dose of the changed T cells that can be given safely.     Researchers also want to learn how long the changed T cells remain in the participant's body,     and if the changed T cells can reliably treat B-cell lymphoma. Finally, researchers want to     learn if interleukin-2 (IL-2) can help the changed T cells last longer in the body.   "
238413|NCT00968773|"     This is a post-market study of the Rebound Hernia Repair Device to further establish the     safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population.     The Rebound Hernia Repair Device will be used for its approved indication in comparison to     standard hernia mesh. Two-way students t-tests, Chi squared analysis and ANOVA will be used     to detect differences in variables. The study is sufficiently powered to detect a 25%     difference.      The study data will include quality of life assessments, visual analogue scale , SF-36,     Carolinas Comfort Scale), recurrence of hernia (technical failure), use of medications (pain)     and complications/adverse events.   "
238414|NCT00968786|"     The home monitoring of automated measuring devices may improve the management of the chronic     diseases, and may decrease the incidence of fatal disease. The investigators conducted a     small sample and short observation time research to explore the feasibility to carry out     later large-scale research.   "
238415|NCT00968799|"     Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the     cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to     systemic, intravenous chemotherapy (usually using the same dose). Although there seems to be     a correlation between body surface and blood volume, the pharmacodynamics of drugs dosed by     the body surface is still highly variable and thus dosing on the body surface is increasingly     considered controversial for systemic administration.      For hyperthermic intraoperative intraperitoneal chemotherapy dosing by the body surface makes     even less sense, since the aim is the highest possible drug concentration in the peritoneum     without undue local and systemic toxicity. Furthermore, most studies using intraoperative     chemotherapy vary the volume of the perfusate according to the size of the patient. Since the     amount of cytotoxic drug is already fixed by the dosing on the body surface (amount [mg] =     dose [mg/m²] x body surface [m²]) the effective concentration (mg/l) in the perfusate can     vary considerably between patients. On the other hand pharmacokinetic analyses have shown     that reducing the concentration of the cytotoxic drug in the perfusate reduces the efficacy     even if the amount of the drug remains the same.      In this study the safety of a new dosing regime will be evaluated. The concentration of     cisplatin in the perfusate will be held constant independent of body weight or size to     achieve the highest effectiveness of the chemotherapy. The primary endpoint is the safety of     the treatment. All patients should be able to receive full dose systemic carboplatin     chemotherapy after completion the trial treatment.   "
238416|NCT00968812|"     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of     canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes     mellitus with inadequate control despite treatment with metformin.   "
238417|NCT00968825|"     The purpose of this study is to evaluate the efficacy and safety of a single administration     of RT001 compared to placebo gel for the treatment of moderate to severe lateral canthal     lines.   "
238420|NCT00968864|"     The primary purpose is to determine the ability of CD34+ selection and T cell depletion using     the CliniMACS® device to prevent severe acute graft-versus-host disease (GVHD) in patients     receiving a stem cell transplant from an alternative (unrelated and mismatched related)     donor. The secondary objectives include evaluation of engraftment, immune recovery, and     post-transplant infections.      Patients requiring stem cell transplants for either malignant (cancerous) or non-malignant     disease will be included in the study. The recipients will be grouped into one of two groups     based on whether the donor is mismatched related (Cohort A) or unrelated (Cohort B). The     patient will receive a conditioning regimen including chemotherapy drugs and/or total body     irradiation based on the disease for which the transplant is performed.   "
238421|NCT00968877|"     Purpose of this study is to investigate the effect of treatment with vitamin D3     (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients     with vitamin D deficiency.   "
238422|NCT00968890|"     The purpose of the present study is to assess the immunogenicity, safety and reactogenicity     of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals'     Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged     61 years and older.   "
238423|NCT00968903|"     The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg     iv) versus placebo on postoperative outcome after hip arthroplasty.      The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to     fulfill discharge criteria.   "
238424|NCT00968916|"     Primary objective: To determine the maximum tolerated dose based on the incidence of dose     limiting toxicity and the maximum administered dose of AVE8062 administered every 3 weeks in     patients with advanced solid tumors.      Secondary objectives:        -  To assess the overall safety profile of the drug.        -  To characterize the pharmacokinetic profile of AVE8062 and its active metabolite RPR          258063.        -  To evaluate anti-tumor activity of the drug.   "
238425|NCT00968929|"     Recombinant streptokinase (r-SK) is an effective thrombolytic agent developed with gene     engineering. Its characteristics of high output and low production cost make it affordable in     treating acute myocardial infarction (AMI) in developing countries. It is unclear whether     r-SK can be used in patients with pulmonary embolism (PE). The aim of this study was to     investigate the efficacy and safety of 1.5 million IU r-SK by 2 hours infusion and 20,000     IU/kg urokinase (UK) by 2 hours infusion in selected PE patients.   "
238426|NCT00968942|"     The purpose of this study is to evaluate the safety and efficacy of 2 sequential doses of     RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.   "
238427|NCT00968955|"     The purpose of the study is to compare the effects of per-operative local infiltration     analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain     intensity after total hip arthroplasty.      The hypothesis is that local infiltration analgesia reduces the acute postoperative pain     intensity.   "
238428|NCT00968968|"     This is a randomized, open-label, multi-center Phase III study evaluating the efficacy and     safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued     HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC). Eligible     subjects will have completed 12 to 24 weeks of first- or second-line treatment with     trastuzumab plus chemotherapy, experienced either complete disappearance of all metastatic     lesions, or persistence of metastatic disease (stable disease) without unequivocal     progression or the occurrence of new lesions, and been indicated to continue to receive     trastuzumab alone as maintenance therapy. Eligible subjects entering the LPT112515 study on     first-line treatment will have no known history of central nervous system (CNS) metastases;     subjects entering the study on second-line treatment will have no known history of CNS     metastases or have stable (asymptomatic and off steroids ≥3 months) CNS metastases. The     primary objective of this study is to compare progression-free survival (PFS) in subjects     with HER2-positive MBC randomized to receive treatment with lapatinib plus trastuzumab versus     those randomized to receive trastuzumab alone. The secondary objectives include overall     survival, clinical benefit response rate (CR, PR or SD ≥24 weeks) and the qualitative and     quantitative adverse event profile of the 2 treatment arms. It is estimated that 280 subjects     (140 per group) will be required to observe 193 PFS events.   "
238429|NCT00968981|"     This is a two stage, Phase Ib study designed to describe the pharmacokinetics of GDC-0449 in     patients with advanced solid tumors that are refractory to treatment or for whom no standard     therapy exists.   "
238430|NCT00968994|"     This randomized, controlled trial is designed to evaluate split-thickness donor sites treated     with exSALT SD7™ compared to donor sites treated with Xeroform®. For the purpose of this     study, subjects enrolled will have selected donor sites or portions of donor sites designated     as Test Sites. The selected locations will be randomly assigned treatment with either the     Test Dressing or the Control Dressing.      The primary objective of the trial will be to quantify the proportion of the donor sites in     each group that are healed at 10 and 14 days. Secondary objectives will include: time to     re-epithelialization, pain with dressing changes and mobilization, ease of use, resource     utilization and safety, as well as quality of healing and overall cosmetic result. A total of     25 subjects will be enrolled in the trial.      The trial duration will be 12 weeks. For the purposes of this trial, healing will be defined     as ≥ 90% re-epithelialization and must be visually confirmed by the investigator or designate     and two other people (i.e., research nurse, burn resident, member of the Wound Care Team).     The maximum time to evaluate healing will be 14 days +/-2 days. A final visit will be     conducted at 12 weeks for safety and to evaluate the quality of healing.   "
238446|NCT00969202|"     The purpose of this trial is to evaluate a short course of very focused (stereotactic)     external beam radiation therapy for the treatment of early stage prostate cancer.      The investigators will gather scientific information about the tolerance and side effects     this type of radiation. The investigators will then compare these results with those of     standard 8 week course of external beam radiation therapy to see if this study treatment is     equally or more effective in treating prostate cancer.   "
238447|NCT00969215|"     The purpose of this study is to determine if fractional carbon dioxide laser treatment of a     burn scar is a more effective method for improving the appearance of scars than the current     available treatments.   "
238431|NCT00969007|"     The primary objective of the study is to identify baseline and early predictors of favorable     and unfavorable response to lifestyle intervention. As a secondary objective, the     investigators would like to validate our questionnaire or other identified predictors as     clinical tools to guide us in selection of the most suitable candidates for lifestyle     intervention programs. Assuming the same capacity of our questionnaire to predict an absence     of weight loss (≥5%) or a loss to follow-up (likelihood ratio for a positive test, LR+ =     9.9), 70 subjects need to be included in this study in order to find a lower limit of the 95%     confidence interval above 2.0 for this LR+, which is the limit of an acceptable test. The     investigators will enroll participants with pre-diabetes and BMI 27-40 in our program and     administer to them at baseline and at 3 months the designed questionnaire, as well as other     already well validated questionnaires assessing state of change and readiness to implement     diet or exercise modifications.   "
238432|NCT00969020|"     The RRS project is a Randomized Clinical Trial documenting the effect of Remote     Rehabilitation and Support via a telemedicine solution for patients undergoing an optimized     fast-track orthopedic surgery procedure with the implementation of a total hip arthroplasty.     With the telemedicine solution the investigators will support and try to motivate the patient     to be discharged after only one day of hospitalization.   "
238433|NCT00969033|"     The purpose of this study is to determine the effect of CS-1008 in combination with     irinotecan compared to irinotecan alone on Progression-Free Survival (PFS) in subjects with     metastatic or advanced colorectal cancer (CRC) who have failed oxaliplatin-based first-line     treatment.   "
238434|NCT00969046|"     This study is exploring different administration schedules (short versus prolonged infusion)     to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with     pretreated advanced colon cancer.   "
238435|NCT00969059|"     This study will be a double-blind, placebo-controlled, parallel group study. After enrolment     and initial assessments, subjects will receive oral GW856553 7.5 milligram (mg) twice daily     (BID) or matching placebo for 28 days in a 1:1 ratio. Sufficient numbers of subjects will be     recruited to obtain 142 evaluable subjects. This is a double-blind, randomized,     placebo-controlled, parallel group study. Subjects will undertake a screening period which     may last up to approximately 3 weeks, followed by a baseline period of 1 week, a randomized     treatment period of 4 weeks and a follow-up period of approximately 2 weeks. This is a     multi-centre, double-blind, randomized, placebo-controlled study in subjects who have at     least moderate intensity of neuropathic pain resulting from peripheral nerve injury due to     trauma or surgery. It will investigate the efficacy, safety and tolerability of GW856553 over     28 days of treatment. Approximately 158 subjects will be randomized to ensure 142 evaluable     subjects. Randomization ratio will be 1:1 for placebo or GW856553 respectively. The dose of     GW856553 will be 7.5 mg BID.   "
238436|NCT00969072|"     The primary objective is to assess the safety of GI198745 0.05mg, 0.5mg, 2.5mg once daily for     52 weeks.   "
238437|NCT00969085|"     The goal of this clinical research study is to learn if treatment with curcumin can help to     decrease the size of lesions and/or decrease itching in patients with MF or SS. The safety of     curcumin will also be studied.   "
238438|NCT00969098|"     Recently, a few small trials have shown promising results on value of     fluoro-2-deoxy-D-glucose and positron emission tomography imaging in response assessment in     Malignant Pleural Mesothelioma. These studies considered different parameters in Positron     Emission Tomography (PET) analysis, mainly the standardized uptake value and volume-based     parameters such as total glycolytic volume.   "
238439|NCT00969111|"     The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or     conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has     already returned or the risk of prostate cancer returning.   "
238440|NCT00969124|"     The Third Eye Retroscope is a device that can be used with a colonoscope to improve the     ability of a physician to see areas of the colon that may be hidden from the view of the     colonoscope.      Previous studies have shown that physicians are able to detect additional polyps when they     use the device along with the colonoscope. The purpose of this study is to determine whether     physicians can detect greater numbers of additional polyps as they gain in experience with     the device.   "
238441|NCT00969137|"     To determine if the mu opioid receptor gene (OPRM1) A118G polymorphism moderates the     subjective-rewarding effects of intravenous (IV) nicotine in male and female smokers. The     subjective effects of nicotine will be measured with a Drug Effects Questionnaire, including     the ratings of good effects and drug liking. We hypothesize that smokers with the AG/GG     genotype for the OPRM1 A118G will have attenuated subjective-rewarding effects from IV     nicotine when compared to those with AA genotype.   "
238442|NCT00969150|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of     Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive     disorder.   "
238443|NCT00969163|"     Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum     excretion rates will be measured before and after 6 weeks of treatment.   "
238444|NCT00969176|"     The purpose of this study is triple, i.e. document single dose pharmacokinetics and -dynamics     of intravenous paracetamol in preterm and term neonates after a loading dose (20 mg/kg iv     bolus paracetamol), document multiple dose pharmacokinetics and -dynamics of intravenous     paracetamol in preterm and term neonates, based on the daily doses routinely used within the     neonatal intensive care unit and as reported in literature. Finally, document safety of     single and repeated dose of intravenous paracetamol in preterm and term neonates.   "
238445|NCT00969189|"     Once a child has been anaesthetised and is fully asleep, a special airway tube called a     laryngeal mask is often inserted into their mouth to help with their breathing. This tube is     removed just before the child wakes up.      A new type of airway tube, called an i-gel airway, has been developed for children, which is     hoped will be easier to insert, safer once in position, and will be less likely to cause a     sore throat after the anaesthetic than a standard laryngeal mask. The adult i-gel airway has     been available for adults since 2007, and early trials have shown very encouraging results.   "
238448|NCT00969228|"     The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human     rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately     6-12 weeks at the time of first vaccination.   "
238450|NCT00969254|"     Clinical Study, prospective, comparative, randomized, double-dummy entry with random from a     total of 80 patients, 40 patients will receive the test medication (Pílulas de Lussen®) plus     placebo and 40 patients will receive the comparative (Pyridium®) plus placebo.   "
238451|NCT00969267|"     The aim of the study is to examine whether the ear acupoint stimulation is effective on obese     women.   "
238452|NCT00969280|"     This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study     hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture     in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham     acupuncture controlled study. Additionally, the investigators will assess the safety of     acupuncture treatment.   "
238453|NCT00969293|"     The purpose of the study is to evaluate the safety and tolerability of a single     administration of FOV2302 (ecallantide) in patients with macular edema associated with     central retinal vein occlusion.   "
238454|NCT00969306|"     Chloroquine might very well be able to increase overall survival in small cell lung cancer by     sensitizing cells resistant to chemotherapy and radiotherapy.   "
238455|NCT00969319|"     The aim of this international prospective post-marketing surveillance study is to obtain data     on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE     Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.   "
238456|NCT00969332|"     The purpose of the study is to investigate if intravenous fish oil, commercially available as     Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in     children.   "
238457|NCT00969345|"     The decreases of physiological capacities which take place with senescence include     diminishing respiratory capacity as well as a reduction of heart rate variability and     baroreflex sensibility. Altogether, these alterations increase elderly people's frailty and     have a negative impact over quality of life. Since Yoga (Indian auto-discipline) has a wide     range of respiratory exercises already investigated as components for non-pharmacological     treatments for hypertension (situation in which heart rate variability is also diminished),     the investigators hypothesis is that the training of respiratory exercises of Yoga may have a     significant positive effect on heart rate variability and baroreflex of health elderly     subjects, increasing quality of life and reducing frailty.      We included 30 health elderly subjects (both sexes, from 60 years-old onwards) divided into 2     randomized experimental groups: control (C) and respiration (R). Each group underwent an     entry evaluation, followed by a 4-months training period, after which they were re-evaluated.     Control consisted of 2 stretching classes per week, and respiration consisted of 2     respiratory exercises classes a week. Both groups were instructed to perform the exercises at     home twice a day, and to keep a record of each session in a log sheet. Evaluations were:     WHOQOL-OLD questionnaire for quality of life, 20 minutes of seated rest with heart rate,     respiration and blood pressure acquired continuously for further spectral analysis.   "
238458|NCT00969358|"     Fast track programs, multimodal therapy strategies, have been introduced in many surgical     fields to minimize postoperative morbidity and mortality. This study is intended to evaluate     a rehabilitation program in comparison with a historical series.   "
238459|NCT00969371|"     The purpose of the following clinical protocol is to evaluate the safety and effectiveness of     the Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) for the protocol     inclusion/exclusion criteria.   "
238460|NCT00969384|"     Aim of the study: To investigate if the intervention described in this protocol has an effect     on patients' and staff's physical health.      Null hypothesis: There is no difference in waist circumference, body weight, quality of life     and the rate of polypharmacy between the intervention and control groups after six months.   "
238461|NCT00969397|"     The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser     therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL)     therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.   "
238462|NCT00969410|"     A pharmacodynamic study to evaluate the effect of AV-299 on exploratory pharmacodynamic     markers in subjects with advanced solid tumors who have liver metastases.      To evaluate safety and tolerability of AV-299 administered IV in subjects with advanced solid     tumors who have liver metastases.   "
238463|NCT00969423|"     The study will investigate characteristics of chronic pain after VATS surgery with two     different sizes of videoscopic equipment.   "
238464|NCT00969436|"     The purpose of this study is to assess non-inferiority of two different vaccination regimens     using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and     one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™     administered at 9 months of age followed by concomitant administration of Priorix™ with     Varilrix™ at 15 months of age in a measles endemic environment such as India.   "
238465|NCT00969449|"     To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen     sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration     for 36 hours under fasted conditions   "
238466|NCT00969462|"     In previous studies, the investigators found that in patients with Hodgkin's lymphoma (HL)     treated with ABVD (adriamycin, bleomycin, vinblastine and decarbazine) the absence of     alopecia may predict for a poor response to treatment [complete remission (CR) rate 79%     versus 31%, P < 0.0005, respectively]. Also, patients without alopecia had fewer episodes of     either leucopenia, neutropenia, deferral of treatment courses or number of courses with dose     reduction [88% vs. 62.5%, P=0.05, for the presence of at least one of them].      One of the explanations for this phenomenon is related to a lower systemic exposure of     chemotherapeutic drugs in patients who retain their hair. There is a wide interpatient     variability in the pharmacokinetic and pharmacodynamic parameters of doxorubicin systemic     exposure and the degree of myelosuppression.      In a pilot study on 18 patients the investigators could not find the previous association     between alopecia, response to chemotherapy and bone marrow depression. However, when     analyzing doxorubicin pharmacokinetics, patients who had no remission had 2 fold lower AUC     (area under the curve) and 3 fold lower peaks (p=0.06). The investigators' lack to approve     the previous findings might be explained by the small study group.   "
238494|NCT00969839|"     This post-market clinical study is being done to evaluate the use of the NovaLign™     Intramedullary Fixation System in the treatment of humeral fractures.   "
238467|NCT00969475|"     The purpose of this study is to determine if fractional carbon dioxide laser treatment of a     fresh wound at the time of surgery, decreases scar formation. Scar revision is commonly done     at 6-10 weeks following surgery. Therefore, it may be more beneficial, for both the patient     and physician, to perform scar revision at the time of surgery.   "
238468|NCT00969488|"     Nearly 20% of women do not return to their pré-gestacional body weight. The purpose of this     study is to investigate the effect of diet and socio-demographics factors during gestation     and postpartum period to body weight change after delivery. This is a clinical trial with 180     women interviewed at 1 (baseline), 2, 3, 4, 5 and 6 months postpartum. The dietary data were     obtained by employing the Food Consumption Frequency Questionnaire with reference to the     first and sixth months of postpartum.   "
238469|NCT00969501|"     The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an     improvement in pain levels and range of motion.   "
238470|NCT00969514|"     Robotic cystectomy is a relatively new procedure previously described only at university     centers. These studies have all been reviews of single surgeon's experiences.   "
238471|NCT00969527|"     The purpose of the study is to assess the efficacy of Oncoxin+Viusid administration in the     treatment of rheumatoid arthritis. The duration of this double-blind placebo controlled phase     3 clinical trial will be 12 weeks. The estimated number of persons with rheumatoid arthritis     to be recruited and randomized for the study is 86. The primary outcome measure: DAS28 score     will be assessed at the end of the study.   "
238472|NCT00969540|"     Sleep quantity and quality can be influenced by the type of mattress used. This study is     being done to see if a mattress cover with optically active particles can help back pain and     improve sleep quality.   "
238473|NCT00969553|"     The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI     6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse     events.   "
238474|NCT00969566|"     It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose     levels in both fasting and postprandial states and preserves pancreatic beta cell function in     patients with type 2 diabetes. Their mechanism of action is derived from increased incretin     (GLP-1) levels, which stimulate insulin secretion as well as insulin biosynthesis and inhibit     glucagon secretion from pancreas. Recent studies reported that combination therapy with     DPP-IV inhibitors and metformin have additive or synergistic effects in lowering glycose     level, preserving beta-cell mass and function as well as enhancing insulin sensitivity.     However, there have been few studies about the difference of glucose lowering effect of     combination therapy of DPP-IV inhibitors and metformin according to the secretory capacity of     pancreas.      The researchers hypothesized that combination therapy with DPP-IV inhibitor and metformin may     have more favorable glucose lowering effect in type 2 diabetic patients who have preserved     pancreatic secretory function. The researchers plan to investigate the difference of glucose     lowering effect of 24 weeks treatment with sitagliptin (DPP-IV inhibitor) in combination with     metformin according to basal c-peptide and glucagon level in type 2 diabetic patients.   "
238475|NCT00969579|"     This study will describe the perceptions of support and distress outcomes of single/lone     parents of a child with cancer.      Background:        -  Parents and families of children with chronic illnesses have stressors, including          financial stress, role strains, separations, and interruptions in daily routines and          plans for the future. All of these experiences may lead directly and indirectly to          parental stress.        -  The number of families headed by single or lone parents is increasing. Little work has          been done to better understand if the needs of parents who are providing care for a          child on their own differ from parents who do not classify themselves as lone.          Identifying parents who may need additional support within a pediatric oncology setting          is very important so that appropriate support is provided.      Objectives:      - To better understand the social, emotional, and practical effects of lone parents on     children with cancer.      Eligibility:        -  All parents whose child has been diagnosed with cancer between 6 and 18 months before          enrolling on the study.        -  Participants must be able to speak and read English      Design:        -  Parents will be asked to complete a questionnaire during one of their child s clinic or          hospital visits.        -  The questionnaire will ask about the parenting experience since the child was diagnosed          with cancer. It will ask about the support the parent has received from family and          friends since the diagnosis.        -  The questionnaire will take approximately 20 minutes to complete.   "
238476|NCT00969592|"     The purpose of this study was to compare the pharmacodynamics (course of the blood     glucose-lowering effect and duration of effect) and pharmacokinetics (course of the     concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg     of insulin glulisine and insulin aspart in a direct head-to-head comparison during two     euglycemic glucose clamps in healthy subjects.   "
238477|NCT00969605|"     Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both as     pressure support (PSV) and pressure controlled (PCV) ventilation. Weaning with ASV shows     promising results mainly in post-cardiac surgery patients. The aim of this randomized     controlled study was to test the hypothesis that weaning with ASV could reduce the weaning     duration in patients with chronic obstructive pulmonary disease (COPD) when compared with     PSV.   "
238478|NCT00969618|"     The purpose of this study is to assess long-term safety and tolerability in adult patients     who have completed a previous atomoxetine study.   "
238479|NCT00969631|"     The purpose of this study is to compare and determine the efficacy of combined metformin and     Clomiphene citrate administration to that of laparoscopic ovarian diathermy (LOD) in     infertile women with Polycystic ovary syndrome (PCOS) not responding to treatment with     Clomiphene alone.   "
238480|NCT00969644|"     Observations in patients with growth hormone (GH)-disturbances have suggested that GH/IGF-I     might have anti-inflammatory effects. To elucidate this hypothesis the investigators have     planned a study to investigate if 3 weeks administration of GH and subsequently the GH     antagonist Pegvisomant (or vice versa) influence serum levels of different inflammatory     markers in healthy volunteers.   "
238495|NCT00969852|"     This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline     with [11C] sertraline positron emission tomography (PET) study.   "
238481|NCT00969657|"     Background of the study:      Prediction of rectal tumor response after chemoradiotherapy (CRT) might be helpful in     individualizing treatment strategies, i.e., selecting patients who need less invasive surgery     or another radiotherapy strategy instead of resection. For rectal cancer it is known that     10-30% of the patients will respond with a pathologic complete response (pCR) after CRT. From     a retrospective study with multivariate analysis of both clinical and 2-[18F]     fluoro-2-deoxy-D-glucose and positron emission tomography (FDG-PET) data, it was found that     adding FDG-PET data collected before and after CRT leads to a more predictive model compared     to evaluating only pretreatment clinical data. To validate this model, this registration     study is proposed. Furthermore, it has been found that FDG-PET during treatment is very     predictive for response and a more favorable time point to adapt treatment. Also, there are     indications that adding blood biomarkers to the data, results in higher accuracy for response     prediction compared to clinical and imaging data alone. Therefore, FDG-PET during treatment     and blood sampling are included in the protocol to improve the accuracy of the prediction     models.      Objective of the study:      The long-term research objective is to be able to select rectum cancer patients who could     receive a less invasive treatment. If prediction of response is possible, surgery may be     avoided when complete response after chemoradiotherapy is expected or performed with smaller     incisions if stage reduction is significant. This support decision system helps to     individualize patient treatment and can improve the quality of life for the patient.      Study design:      28x radiotherapy. On day 15 of radiotherapy en 8 weeks after radiotherapy: 1 PET-CT scan     Before radiotherapy, on day 15 and 8 weeks after radiotherapy: blood sample taken.   "
238482|NCT00969670|"     Samples of sputum from asthmatic children, between 5-17 years, will be collected during two     years of the study period to perform tests Particle Size Distribution (PSD) and Shape     Analysis (SA) of the particulate matter in the sputum and a biochemical reaction to evaluate     the activity of Heme Oxygenase-1 protein in sputum cell supernatants.      Each child will perform Pulmonary Function Testing (PFT) and Induced Sputum (IS) as a routine     part of diagnosis of asthma.      Parents will be asked to complete a questionnaire including questions on their child's     respiratory symptoms in the last 12 months as well as socioeconomic factors. Parents will be     asked to give informed written consent for their child's participation in the study.   "
238483|NCT00969683|"     Most teams use a left double-lumen tube. The double-lumen tube is available with or without a     carinal hook. The hook is supposed to facilitate the positioning of the tube and avoid the     mobilization of the tube during surgery. The use of double-lumen tubes with a hook is large     in Europe and quite unknown in US. The literature is poor, containing only few case reports.      The purpose of this research is to compare the two types of left double-lumen tube.   "
238484|NCT00969696|"     To evaluate galantamine's effects on cognitive performance in marijuana users. Galantamine,     an acetylcholine esterase inhibitor, is approved for treatment of Alzheimer's disease.     Current marijuana users show impaired cognitive functioning, which predicts poor treatment     response to behavioral treatments in this population. Whether cognitive impairment in     marijuana users will improve with medication treatment has not been evaluated. We hypothesize     that galantamine, compared to placebo, will improve cognitive performance in marijuana     users.Galantamine, compared to placebo, will improve working memory, verbal learning/memory     and response inhibition functions in marijuana users.   "
238485|NCT00969709|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of     Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major     depressive disorder.   "
238486|NCT00969722|"     This is a multicenter, randomized, controlled, open-label study. Patients meeting     inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus     GM-CSF or RA plus GM-CSF. Patients who do not respond to their assigned treatment after two     cycles may cross-over to receive the alternate treatment. Disease response and safety will be     assessed in all patients after cycle 2 and after cycle 4.   "
238487|NCT00969735|"     This is a prospective single-center randomized trial comparing the efficacy and safety of PV     cryoablation with the Arctic Front® catheter versus the standard PV isolation using     radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated     from a clinical point of view and from the detection and quantification of AF episodes by     means of the Reveal XT® implantable loop recorder.   "
238488|NCT00969761|"     The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI     6727 therapy in terms of drug-related adverse events when combined with a platinum therapy     (cisplatin or carboplatin).      Secondary objectives are the collection of overall safety and antitumour efficacy data and     the determination of the pharmacokinetic profile of BI 6727 combination treatment with     cisplatin and carboplatin.   "
238489|NCT00969774|"     Introduction:      Human face with its bony and muscular structures has singular and peculiar characteristics.     It may be classified in three types, associated with the variation of shape and craniofacial     configuration, both in vertical and horizontal planes, directly affecting dental occlusion,     face harmony, orofacial musculature and oral functions. Aim: to correlate cephalometric with     anthropometric and facial analysis findings on determining the facial type.      Method:      105 leukoderm adults were involved, 34 male and 71 female aging between 20 and 40 years old.     Data were collected in December 2006 in an orthodontic clinic located at Belo Horizonte- MG,     Brazil. Cephalometric findings to determinate facial types were compared to seven     anthropometric facial measurements, three anthropometric facial proportions and three     anthropometric facial indices, in addition to facial type identification through clinical     facial analysis of photographs.   "
238490|NCT00969787|"     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and     pharmacodynamics of orally administrated DWP05195 in healthy male volunteers.   "
238491|NCT00969800|"     This study is to test whether a chlorine dioxide gas-generating device, which releases a low     concentration gas of chlorine dioxide in a sustained manner, can protect against respiratory     infections in elderly individuals living in nursing homes. Such a device is used as a     deodorant for normal domestic purposes. The investigators reasoned that the antiviral and     antibacterial properties of chlorine dioxide might lead to a lowering in the incidence of     respiratory infectious diseases. The study is designed as a randomized placebo-controlled     double-blind crossover multicentre trial involving approximately 1500 subjects.   "
238492|NCT00969813|"     This study is designed to evaluate how CP-690,550 is handled by the body in healthy     volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with     normal hepatic function. This study will also evaluate the safety and tolerability of     CP-690,550.   "
238493|NCT00969826|"     This study is a four arm, parallel study.      Ten were administered a single subcutaneous administration of 30, 100 and 300 μg/kg of GCPGC     or placebo for each group (active:placebo=8:2). Eight were administered a single subcutaneous     administration of 100 μg/kg of Neulasta (an active comparator).   "
238496|NCT00969865|"     This study will evaluate the effectiveness of an individualized approach to diagnosing and/or     treating atherosclerosis. This will be done by combining genetic information, lifestyle     information, participant education, and imaging tests to track diagnoses, therapies, and     treatment on two groups: 1) Standard Management Group (diagnosed and/or treated according to     standard of care) and 2) Individualized Management Group (standard of care plus genetic     testing and coronary artery calcium scans).   "
238497|NCT00969878|"     The purpose of this study is to test the efficacy of a newly developed active vaccine against     cocaine (TA-CD).   "
238498|NCT00969891|"     The present study is not hypothesis driven but will explore the ability of     pharmacokinetic-pharmacodynamic modelling to predict optimal dosage of the chemotherapeutic     drugs used in therapy in adult patients with acute myeloid leukemia.   "
238499|NCT00969904|"     Studies suggest that N-acetylcysteine (NAC) potentially reduces inflammation and     hyperinflation in patients with COPD.      In this pilot study the efficacy, safety and tolerability of high dose NAC in 12 patients     with moderate COPD will be examined. These patients will receive a placebo for 12 weeks and     NAC for 12 weeks in a dosage of 3 times 600 mg a day on top of their usual medication in a     randomized crossover design. All subjects will be followed for 28 weeks.      The effect of high dose NAC on small airways will be assessed by measuring the total and     peripheral airway resistance calculated with Computational Fluid Dynamics (CFD). The effect     on oxidative stress will be assessed by measuring exhaled NO and specific markers (CRP,     erythrocyte sedimentation rate, IL-6, 8-isoprostane, H2O2, TNF-alfa, glutathione, GPX, SOD     and IL-8) in blood and Exhaled Breath Condensate (EBC). Dynamic and static lung volumes will     be assessed by spirometry, body plethysmography and diffusion. Quality of life and symptoms     will be assessed by the St George Respiratory Questionnaire.   "
238500|NCT00969917|"     The primary objective of the study is to determine the safety profile and overall response     rate of IPI 504 in patients with advanced dedifferentiated liposarcoma.   "
238501|NCT00969930|"     This is a genetic association study of cognitive impairment in young bipolar disease type I     patients without medications in mania, depression, hypomania or mixed states.   "
238502|NCT00969943|"     The purpose of this study is to evaluate whether men and women respond differently to seeing     items related to cocaine use or to remembering stressful events. Four groups of individuals     will be recruited to participate in this study: men with cocaine dependence, women with     cocaine dependence, men without cocaine dependence, and women without cocaine dependence.      Hypothesis #1: Cocaine-dependent women will demonstrate smaller increases in neuroendocrine,     but greater increases in heart rate and more cocaine craving and subjective distress when     exposed to stress as compared to cocaine-dependent men and non cocaine-dependent men and     women.      Hypothesis #2: Cocaine-dependent men will demonstrate greater increases in neuroendocrine,     but greater increases in heart rate and more cocaine craving and subjective distress when     exposed to cocaine-related cues as compared to cocaine-dependent women and non     cocaine-dependent men and women.      Hypothesis #3: Cocaine-dependent women will demonstrate greater increases in heart rate and     more cocaine craving and subjective distress when exposed to stress inducing stimuli as     compared to their own responses to a cocaine-related cue.      Hypothesis #4: The neuroendocrine response to a stress hormone (corticotropin releasing     hormone; CRH) will be greater in cocaine-dependent women as compared to cocaine-dependent     men.   "
238503|NCT00969956|"     Diabetes causing serious complications is well known. In this study the aim is to follow 950     patients with diabetes for 15 years to study when, in who and how the diabetes complications     occurs.   "
238504|NCT00969969|"     This study will evaluate whether Cartiva is an effective treatment for individuals with     osteoarthritis of the great toe.   "
238505|NCT00969982|"     The primary goal of this study is to determine the clinical advantage of pre-treatment with     mifepristone in second trimester misoprostol induction abortion. This will be a randomized     controlled double-blinded trial of 120 women in each country comparing misoprostol alone to     mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.   "
238506|NCT00969995|"     Migraine is prevalent in 10-12% of the population. It involves the development of a cranial     perivascular neurogenic inflammation. Recent information suggests that migraine might be a     risk factor to stroke. The possible mechanisms that might relate migraine and stroke are: 1.     Migraineous infarction 2. A primary endothelial disorder. 3. Genetic relation 4. An ongoing     inflammatory process. C reactive protein (CRP) is a sensitive marker for an inflammatory     process.The data on the relation of migraine to inflammation is limited. The aim of the     current study is to assess inflammatory factors as possible markers for migraine.   "
238507|NCT00970008|"     In 2004, we conducted a pilot randomized, wait list controlled, trial (RCT) of massage     therapy for OA of the knee in 68 subjects. That study, supported by CDC grant SIP-14-00,     revealed the potential efficacy of Swedish massage therapy in the treatment of OA of the     knee, with benefits of increased function and decreased pain persisting at least eight weeks     following treatment cessation. The results of that trial, the first RCT of massage for OA,     were published in the Archives of Internal Medicine in 2006 (See reference in More     Information section). This current project builds on the design and findings of the pilot     trial to determine the optimal dose and treatment regimen and provide longer term follow up.     This project is a dual-site, randomized, dose-ranging trial to compare four dose/regimens in     order to identify the optimal protocol for clinical practice.      The primary study hypothesis is that an eight (8) week course of Swedish massage therapy of     one of the four proposed doses (by frequency and duration of massage treatment session) will     be effective in reducing pain and improving function in patients with confirmed OA of the     knee.   "
238508|NCT00970021|"     Extract from the mushroom Agaricus blazei Murill har been shown to have strong     immunomodulating properties both in cell cultures, animal models and in humans. Furthermore     antitumor properties have been shown in animal models, among them in mice with multiple     myeloma. The investigators now want to investigate the effect of Agaricus as supplementary     treatment in addition to chemotherapy in patients with multiple myeloma.   "
238509|NCT00970034|"     The aim of this project is to determine the morphological criteria of apoptosis in atrial     tissues of patients with AF versus SR at transcriptome and genomic size.   "
238510|NCT00970047|"     Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.   "
238512|NCT00970073|"     This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed     start of the anti-rejection drugs (10 days after liver transplant), compared to the current     approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2     days after the liver transplant.   "
238513|NCT00970086|"     For surgery in the region of the lower abdominal wall the administration of local anesthetic     drugs in the epidural space via the caudal route is the preferentially used technique since     several decades.      The transversus abdominis plane (TAP) block features the advantages of a peripheral nerve     blockade. The aim of this study is to evaluate potential differences in the effectiveness of     postoperative analgesia and to test the hypotheses that the duration of pain relieve ist     prolonged after a TAP block when compared with an epidural technique.   "
238514|NCT00970099|"     The study is designed to test the following primary hypothesis:        -  Aerobic exercise training will improve insulin sensitivity in insulin resistant subjects          through changes in the major cellular signaling pathways and and/or their regulators.      Accordingly, the proposed study is designed to accomplish the following specific aims:        -  Quantitate how exercise training improves insulin sensitivity and decreases          cardiovascular risk factors in a general population of lean, nondiabetic, insulin          resistant subjects. Effects on known cardiovascular risk factors including blood          pressure and serum lipoproteins will be evaluated. Change in regional adiposity will          also be measured        -  Determine the effects of a program of regular aerobic exercise on in the insulin          receptor signaling pathway. Biopsies of vastus lateralis muscle from insulin resistant          subjects will be obtained before and after a hyperinsulinemic glucose clamp. This          procedure will take place in the untrained state and after exercise training. The          investigators will measure changes in the insulin receptor and the activity of the major          components of the intracellular insulin signaling pathway. The investigators will also          look intracellular proteins that regulate this signaling pathway.   "
238515|NCT00970112|"     The purpose of this study is to investigate whether preemptive medication with dexamethasone     or etoricoxib provides better pain management and control than placebo following periodontal     surgery.   "
238516|NCT00970125|"     The purpose of this study is to study whether preferences for the goals of care for 80     subjects with end-stage cancer are altered after viewing a video outlining the goals of care     compared to their initial preferences after hearing a verbal description of the goals of care     alone.   "
238517|NCT00970138|"     Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor     receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The     investigators' phase I study has shown that the drug's toxicity is manageable and the maximum     tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib     can improve progression free survival compared with placebo in patients with metastatic     gastric carcinoma who failed two lines of chemotherapy.   "
238518|NCT00970151|"     The hypothesis of this study is that maternal and fetal biologic variation in the balance     between pro-inflammatory and anti-inflammatory mediators can be measured by currently     available techniques. In addition, the investigators hypothesize that a pro-inflammatory     maternal phenotype increases the risk of fetal exposure to intrauterine hyperthemia and     inflammatory cytokines; and that intrapartum events, especially known risk factors for fever     at term such as epidural analgesia and prolonged rupture of membranes, may interact with     underlying maternal factors to increase fetal exposure to inflammatory cytokines.      This experiment aims to establish the first large-scale cohort to evaluate biomarkers for     maternal and fetal inflammation in term pregnancy and to elucidate the relative antepartum     and intrapartum contributions to fetal inflammation.   "
238519|NCT00970177|"     This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate     immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new     swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly     subjects. A booster dose will be administered 12 months after the first vaccination.   "
238520|NCT00970190|"     The study examines the biochemistry underlying human olfaction in both normal and diseased     states.      The study aims are: 1. to determine the levels of cAMP in olfactory tissue from people with     chronic rhinosinusitis and other nasal disorders. 2. to correlate preoperative olfactory     function with cAMP levels from biopsied olfactory tissue. 3. to determine odorant and     pheromone-mediated activation of cultured human olfactory sensory neurons using calcium     imaging and 4. to determine odorant and pheromone-mediated activation of cultured human     olfactory sensory neurons using smell-chip technology.   "
238521|NCT00970203|"     This study will evaluate the feasibility, safety, and efficacy of intradermal vaccination of     prostate cancer patients with alpha-type-1-polarized dendritic cells (DC1) loaded with     apoptotic allogeneic tumor (LNCap). The study will target men with recurrent prostate cancer,     who failed local therapy, have no measurable metastasis, but have a rising PSA with a     doubling time of less than 10 months. The selection of this study group enables us to     evaluate time to PSA progression, a highly relevant, clinical primary endpoint of efficacy in     this two arm study. In order to facilitate infiltration of vaccination-induced T cells into     tumor site(s) and to reduce tumor-specific tolerance, subjects will receive the vaccine in     combination with limited androgen ablation (AA) with a LHRH analogue for 3 months. Subjects     will be randomly assigned to one of two cohorts. In cohort A subjects will be first treated     with limited AA alone for 3 months, and at the time of PSA relapse (PSA ≥ 1 ng/dL) will     receive the DC vaccine in conjunction with AA. In cohort B, the sequence of treatment will be     reversed. Efficacy will be estimated as the within-subject difference in time to PSA relapse     following the combination treatment as compared to the AA alone, thus, each subject will     serve as his own control. All subjects will commence the DC1-based vaccination 2 weeks prior     to treatment with the LHRH analogue. Each subject will receive 1 intradermal (i.d.) dose of     the vaccine at weeks 1, 5, 9, and 13 for a total of 4 doses. Additional courses of     vaccination may be administered to subjects without evidence of disease progression every 3     months (±1 month) for up to 12 months depending on the number of doses originally produced     and available after the 4 intended protocol doses. All doses of the vaccine will be     administered intradermally (i.d.).   "
240583|NCT01004393|"     The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving     opioid-induced constipation in cancer patients at various stages of disease.   "
238522|NCT00970216|"     The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of     telbivudine by maintained suppression of hepatitis B virus (HBV) DNA (<=300 copies/ml or     60IU/ml, undetectable by current polymerase chain reaction (PCR) - based assays) in HBeAg     positive/negative patients at physician's general practice.   "
238523|NCT00970229|"     The underlying goal of this study is to assess [123I]MNI-420 SPECT imaging as a tool to     detect A2aR density in the brain of PD and HD research participants to be compared with     similarly aged healthy subjects.   "
238524|NCT00970242|"     Ambulatory Urodynamic measurement on patients with diminished or absent bladder contractility     before and after trial with Sacral Neuromodulation therapy.   "
238525|NCT00970255|"     Upper lingual frenulum have been implicated as a cause for pain during breastfeeding and     latch problems. The investigators hypothesize that performing frenotomy of the frenulum may     improve breastfeeding. The investigators will include breastfeeding infants with pain or     latch problems in whom the lingual frenulum had been treated but breastfeeding problems were     not resolved. The investigators plan to study the effect of frenotomy of the upper lingual     frenulum on maternal pain (using pain score by visual analog scale) and/or latch score.   "
238526|NCT00970268|"     The purpose of this extension study is to evaluate the long-term safety, tolerability, and     efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe     chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a     52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week     lead-in study. All patients will be randomized from the lead-in study at one of two doses of     aclidinium.   "
238527|NCT00970281|"     The primary objectives of the study is to confirm if the efficacy of intramuscular injection     (IM) olanzapine 10 milligrams (mg) in patients with an exacerbation of schizophrenia with     acute psychotic agitation is greater than intramuscular placebo by comparing changes from     baseline to 2 hours after the first IM injection of agitation.   "
238528|NCT00970294|"     Limited participation in health promotion activities is noted in people with diabetes, even     though lifestyle changes have been found to be essential in decreasing the risk of     complications of the disease. The purpose of this study is to gather preliminary data to     assess the feasibility of an intense, customized health promotion program in people with     diabetes, and to evaluate outcome measures following participation to determine effect size     for future studies. Subjects with type 2 diabetes will participate in a 10-week health     promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic     and strength training exercises with a schedule of progression, individual nutrition     counseling, and diabetes health education sessions.   "
238529|NCT00970307|"     This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A     vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A)     vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.   "
238530|NCT00970320|"     Traumatic tears of the sphincter ani muscles after delivery may result in symptomatic urinary     and anal incontinence, particularly in primiparas.      The efficacy of pelvic floor muscle exercise (PFME) in treating urinary incontinence (UI)is     well documented, however, to date there is little evidence to support the efficacy of PFME in     treating symptomatic anal incontinence.      This project consists of three separate studies. The prevalence survey/ study (1),     investigates the prevalence of symptomatic anal incontinence among primiparas at Ostfold     Hospital Trust Fredrikstad, Norway and St Olav's Hospital, Trondheim University Hospital,     Norway, and the results in this study will form the basis of the two identical randomized     controlled trials (RCT) investigating the treatment efficacy of PFME two groups of postpartum     women. Women reporting symptomatic anal incontinence at six months postpartum (2) and women     who have sustained a traumatic 3rd or 4th degree tear of the sphincter ani muscles during     delivery (3), respectively, are randomized to an intervention group receiving PFME treatment     for six months, or a control group. All RCT participants will undergo examination of PFM     strength and activity, as well as anal ultrasound prior to randomization and after the     intervention period.   "
238531|NCT00970333|"     Ultimately a marker of microglial activation could be used for large-scale quantitative brain     imaging trials in Alzheimer Disease (AD), Parkinson Disease (PD) or Multiple Sclerosis (MS),     specifically to investigate the agent as an objective biomarker in treatments aimed at     reducing inflammatory changes in these conditions. The significance of this work lies in     applying state-of-art quantitative neuroimaging tools to develop a relevant biomarker in     individuals with neurodegenerative diseases with the intention of using this efficiently in     large clinical imaging trials.   "
238532|NCT00970346|"     Cystic fibrosis (CF) is a disease caused by a mutation in the gene that makes the cystic     fibrosis transmembrane regulator protein. As a result mucus stagnation, obstruction and     plugging take place in the respiratory and gastrointestinal tract, the biliary and pancreatic     duct, and in the reproductive system. The objective of this study is to determine the safety     and tolerability of 3 days of daily dosing of OligoG CF-5/20 versus placebo in healthy     volunteers.   "
238533|NCT00970359|"     The purpose of this study is to find out if the drug AZD6244 can improve the radioactive     iodine uptake by the patient's metastatic thyroid cancer. The investigator will also be     testing the tumor specimen taken at the time of your surgery for specific genetic changes to     see if one of them in particular (the BRAF oncogene) makes your cancer more likely to become     sensitive to radioactive iodine after treatment with the drug.      The investigators want to find out if AZD6244 helps to increase the entry of radioactive     iodine into thyroid cancer cells that have spread and are resistant to radioactive iodine     therapy, especially if they have the BRAF mutation. To measure how much iodine can enter your     cancer, the investigators will use iodine-124, a different form of radioactive iodine.     Iodine-124 allows the investigators to measure precisely how much radioactivity can enter the     cancer cells, whereas iodine-131 does not. The process of scanning with iodine-124 is called     lesional dosimetry. Iodine-124 is an investigational agent approved by the FDA (Food and     Drug Administration) for use in this research study.   "
238560|NCT00970710|"     This study aims to prevent childhood obesity with early life (pregnancy) intensified     counselling. The recruited intervention group is pregnant mothers who are at risk to get     gestational diabetes. Lifestyle intervention (nutritional and physical activity) begins     during pregnancy in maternity clinics and continues in child wellfare clinics until the child     is 5 years of age.   "
238534|NCT00970372|"     The Norwegian Social and Welfare Act of 1992, opened for compulsory commitment of patients     with serious alcohol and drug problems to inpatient care. Clinical research of compulsory     committed dual diagnosed patients is to date unavailable and is demanded by the health     authorities of Norway. Because there has been limited examination/screening and no     post-treatment research efforts on this group of patients, the investigators have limited     knowledge of the treatment as well as the patient group. Do compulsory treated patients     differ from those voluntarily admitted? Does this type of treatment influence the patients'     motivation to change their behaviour, and does the treatment effort lead to positive outcome     effects in the long run?      The primary aim is to acquire new and in depth descriptive knowledge about the compulsory     treated group of patients according to: Drug dependence, psychiatric and somatic co-morbidity     and socio-demographic characteristics, and investigate whether the treatment yields the     intended outcomes in terms of improved substance abuse measures.      A second aim is to compare the group with a corresponding group of voluntarily admitted     patients within the same wards. A follow-up interview focusing on motivational issues within     6 months post treatment to evaluate the long-term results of the treatment is planned.      A quasi-experimental, prospective case-control study will be conducted. Compulsory committed     patients in five counties during a two year period, will be compared to a group of     voluntarily admitted patients. The groups will be compared regarding 1) description and     screening 2) motivation to change and 3) outcome results after 6 months.      Both official authorities as well as clinical practitioners would benefit from valid     Norwegian results and knowledge within this field to form further policies and evidence based     best practice for this vulnerable group of patients.   "
238535|NCT00970385|"     This is a multicenter randomized trial evaluating induction treatment with     VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T     cell lymphoma.   "
238536|NCT00970398|"     The specific objectives of this study are to evaluate the effects of bovine milk osteopontin     added to infant formula on infant growth, health and immune functions.   "
238537|NCT00970411|"     The purpose of this study is to assess the safety and tolerability of KRN951 administered to     patients with solid tumors. In the single dose period, patients in each cohort will receive     one oral dose of KRN951 in the first day, followed by a 6-day rest period during which no     treatment is received. After that, patients in each cohort will receive one oral dose of     KRN951 daily over a 21-day treatment period, followed by a 7-day rest period during which no     treatment is received. Treatment will be continued in the absence of disease progression or     unacceptable adverse events.   "
238538|NCT00970424|"     This study will evaluate the safety and efficacy of dutogliptin in patients with type 2     diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.   "
238539|NCT00970437|"     The purpose of this study is to compare the efficacy of the Cognitive Behavioural Analysis     System of Psychotherapy (CBASP) with the non-specific System of Supportive Psychotherapy     (SYSP)in early onset chronically depressives.   "
238540|NCT00970450|"     1. Introduction           Paracetamol, an analgesic prescribed daily, has been in use for more than 50 years.          Surprisingly, its mode of action is still unclear. One postulated mechanism is the          reinforcement of descending inhibitory pathways. A recent publication in a human pain          model raises the question of whether or not Paracetamol acts according to a central          serotonergic mechanism. Unfortunately, the chosen model was unable to differentiate          between overall pain, secondary hyperalgesia and allodynia. In particular, secondary          hyperalgesia and allodynia are central effects.           The planned study will examine the central analgesic effects of paracetamol on allodynia          and hyperalgesia by blocking the central effect by adding tropisetron. It will be based          on an internationally accepted model for the initiation of secondary hyperalgesia, which          was developed and tested by colleagues in Erlangen.        2. Study work plan           This prospective, randomized, placebo-controlled, double-blinded, cross-over trial in 16          male volunteers will address pain ratings and the area of secondary          hyperalgesia/allodynia in a human model of electrically evoked pain and compare four          different treatment scenarios:             -  Paracetamol 1 g;             -  Paracetamol, 1 g and Tropisetron 5 mg;             -  Tropisetron, 5 mg; and             -  Saline.           Each volunteer will be allocated to each scenario in a cross-over fashion. Four separate          treatment trials, at least two weeks apart, will be performed. Each volunteer will be          familiarized with the stimulation procedure prior to participation.        3. Ethical considerations           Informed consent will be obtained from each volunteer. In addition, each volunteer will          receive remuneration after participating in the study.           Paracetamol is considered to be a very safe drug in healthy patients. Tropisetron,          another safe medication, is routinely used in anaesthetic practice as an antiemetic          drug. Headache, flush and liver parameter elevation are very rare side effects of minor          importance in our daily clinical work as anaesthetists.           This pain provoking procedure was developed at the University Erlangen Germany. It is a          standardized method and has repeatedly received approval by research ethics committees          internationally. Furthermore, the investigators applied this model to a recent study in          Basel (cf your decision study protocol 330/07; unpublished data, analysis and writing          in progress).        4. Patient number and timetable           The investigators will examine 16 volunteers and expect the experimental component to          last 3 months. The investigators plan to complete this study within one year.        5. Study importance      The mode of action of paracetamol remains unclear. The investigators think that this study     will enable them to answer important questions concerning the action of paracetamol. The     investigators hope that further understanding of this regularly prescribed drug will help us     to better understand the complex mechanisms of pain.   "
238541|NCT00970463|"     To test the hypothesis that both lack and excess of growth hormone (GH) is associated with     cardiac abnormalities. Cardiac function and morphology will be evaluated by MRI before and     after treatment.   "
238542|NCT00970476|"     To determine if arterial stiffness as measured by non-invasive pulse wave velocity can     predict the response to resynchronization therapy in heart failure.   "
238543|NCT00970489|"     This is a large multi-center study to examine whether peri-operative intake of n-3     polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial     fibrillation or flutter (AF) in patients undergoing cardiac surgery (CS).   "
238544|NCT00970502|"     There is no optimal treatment for patients with recurrent head and neck cancer after previous     radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10     months. Surgery is not always possible and often cannot remove every cancerous cell. On the     other hand, reirradiation with chemotherapy cures approximately 25 to 30% of patients but has     significant toxicity with as many as 15 to 20% suffering from life-threatening or fatal     complications. Therefore, less toxic and more effective reirradiation regimens are urgently     needed. There are extensive data from animal studies and preliminary human studies showing     that blocking epidermal growth factor receptor (EGFR) and COX-2 enhances radiation effect and     is more effective than either treatment alone. Erlotinib is a FDA approved oral inhibitor of     EGFR and celecoxib is a FDA approved COX-2 inhibitor. Both have been well studied in humans     and appear to have less severe toxicity than conventional chemotherapeutic agents.   "
238545|NCT00970515|"     The aim of this study is to compare immediate and long-term (24 months) results of     laparoscopic and open mesh repair of incisional and umbilical hernia.   "
238546|NCT00970528|"     The purpose of this study is to evaluate the efficacy and safety of acarbose in comparison     with voglibose in type 2 diabetic patients whose blood glucose levels were inadequately     controlled with insulin glargine alone or in combination with metformin.   "
238547|NCT00970541|"     The purpose of this study is to determine whether Cinnamon from the Cassae Plant is effective     in the body as insulin could lower blood sugar levels.   "
240028|NCT00990249|"     The goal of this clinical research study is to test the safety of giving clofarabine in     combination with busulfan, followed by an allogeneic (from a donor) stem cell transplant, in     patients with advanced leukemia or lymphoma.   "
238548|NCT00970554|"     Amblyopia is a visual impairment of one eye that results from disuse of that eye during early     brain development. The standard treatment for amblyopia consists of patching or     pharmacological penalization of the sound eye. Unfortunately, approximately 50% of amblyopic     children do not respond to these therapies, with poor compliance being a major factor in     treatment failure. One new treatment strategy involves patching the sound eye while using a     telescopic device on the amblyopic eye to magnify the images formed in the amblyopic eye.     Children were randomized to receive either daily patching of the sound eye for 30 minutes     only (patching only group), or daily patching of the sound eye for 30 minutes plus     simultaneous use of a telescopic device by the amblyopic eye during patching (patching plus     telescope group).   "
238549|NCT00970567|"     The purpose of this study is to investigate individuals with type 1 diabetes who were     disconnected from their insulin pump and insulin therapy was started again after positive     ketones (U) in the urine or blood β-hydroxybutyrate.   "
238550|NCT00970580|"     The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are     effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.   "
238551|NCT00970593|"     This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects     with type 2 diabetes who are taking metformin for their diabetes.   "
238552|NCT00970606|"     To assess the efficacy and safety of oral rosuvastatin in patients with suspected or     confirmed influenza who require intensive care unit (ICU) admission due to respiratory     distress.   "
238553|NCT00970619|"     Rationale: Iliofemoral deep venous thrombosis (IFDVT) is associated with significant post     thrombotic morbidity. The presence of both obstruction and reflux significantly increases the     chances for development of post-thrombotic syndrome (PTS). Early thrombolysis may reduce the     incidence of PTS as compared to treatment with conventional anticoagulant medication alone.     Improvement of the health related quality of life (HRQOL) has been reported after surgical     clot removal. The investigators hypothesize that such improvements could also be reached     after catheter directed thrombolysis.      Objective: To assess whether catheter directed thrombolytic therapy for the treatment of     IFDVT can safely and effectively reduce post thrombotic morbidity after one year. The     secondary objective is to study whether catheter directed thrombolytic intervention has a     positive effect on the quality of life of patients with IFDVT and to assess late PTS.      Study design: prospective, non blinded, randomized, controlled, multicenter, intervention     study Study population: The study population includes all consecutive patients with IFDVT     presenting at the emergency or outpatient departments of the participating centres. The     thrombus should not be older than 14 days at randomization.      Intervention: After randomization patients will be allocated to either conservative     anticoagulant treatment or to catheter directed thrombolysis combined with conservative     anticoagulant treatment.      Main study parameters/endpoints: The primary efficacy outcome is the incidence of PTS at one     year; a decline in PTS incidence from 25% to 8% is anticipated. The secondary outcome is the     Health related Quality of life and late PTS during follow-up. The principal safety outcome is     major bleeding during anticoagulant therapy. Bleeding as well as events of recurrent     thrombosis will be monitored. The patency of the venous system of the affected lower limb     will be assessed as well as the percentage of clot lysis, after thrombolytic intervention.     Additionally, measurements of markers of coagulation and inflammation will be performed     during follow-up.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: For patients who are randomized to the intervention arm of the study a hospital     stay for 24-36 hour is mandatory during catheter directed thrombolysis. All patients will     undergo additional imaging by MRA-vasovist and air phletysmography (APG) at baseline and     after 12 months. Clinical follow-up visits will be matching usual care at 3, 6, 12 months;     blood will be taken at these visits. Health-related quality of life (HRQOL) questionnaires     will be filled out by all patients at baseline, 3, 6 and 12 months after the event; and once     a year during the entire study duration. Further treatment will be in accordance with current     guidelines for antithrombotic treatment. There may be an enhanced risk of bleeding in the     thrombolysis group. The expected benefit is reduction of PTS from 25% to 8%, together with an     improved quality of life.   "
238554|NCT00970632|"     The purpose of this study is to determine whether an experimental drug known as tadalafil     given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia     (straining, urinary frequency, feeling like your bladder is still full etc.)   "
238555|NCT00970645|"     This is a prospective randomized clinical trial with the study cohort comprised of all male     and female patients over the age of 21 presenting to the study site for evaluation of lung     cancer. The study will enroll 300 subjects, with 150 in each arm. Three sites will be in the     study, Mayo Rochester, Mayo Jacksonville and Medical University of South Carolina. Mayo     Rochester will enroll approximately 125 subjects. This study does not require subjects to     undergo any additional procedures than what they would receive per standard medical care. The     consenting subjects will receive EUS and /or EBUS- guided FNA or     Mediastinoscopy/Thoracoscopy.   "
238556|NCT00970658|"     The purpose of this study is to evaluate the efficacy in reducing signs and symptoms in     patients with contusions, sprains, muscular injuries and injuries with less than 24 hours     early or holders of myalgia, pain and tendonitis in regions miofasciais articulated with     Salonsip compared to Sabiá plaster.      It is clinical, open, multicenter, randomized, prospective and comparative, with patients     entering at random.      Patients will be included in sufficient quantity to achieve the minimum number of 70     evaluable patients.   "
238557|NCT00970671|"     The purpose of this study is to determine whether treatment of fresh surgical scars with a     pulsed dye laser using purpura-inducing settings will improve clinical appearance better than     one using non-purpura-inducing settings or no treatment.   "
238558|NCT00970684|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab     together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel     and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or     recurrent non-small cell lung cancer.   "
238559|NCT00970697|"     Background: No medical treatment has proved its efficacy for the treatment of hypertensive     leg ulcers in a well designed trial.      Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated     with becaplermin gel (Regranex Gel®) daily application versus the application of the same     quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin     gel.      Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were     randomized to receive either a daily application of becaplermin gel or hydrogel during 8     weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed.      Primary aim of the study: Complete closure at week 8      Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12,     pain and quality of life during treatment      Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be     an alternative medical treatment to the skin graft usually proposed   "
238561|NCT00970723|"     Macular edema remains a major cause of vision impairment in diabetic patients. Its     pathogenesis is multifactorial and incompletely understood. Systemic factors seam to play a     role in this pathogenesis, including high blood pressure. The objective of the study is to     evaluate the effect of an intensified intervention on blood pressure and sleep apnea with     that of conventional treatment in patients with type 2 diabetes and diabetic macular edema.   "
238562|NCT00970736|"     The goal of this project is to examine the area of the brain that controls muscle movement     for a group of muscles important for swallowing, and to see how that area changes over 2     weeks of time.   "
238563|NCT00970749|"     This is an exploratory study in which the investigators will develop a way to identify the     cell responses most strongly associated with protection against chlamydia infection. This     study is not driven by a hypothesis.   "
238564|NCT00970762|"     This study was conducted to determine and compare the safety and effectiveness of two     neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are     undergoing general elective surgery with sevoflurane anesthesia.      Study participants received an intubating dose of a neuromuscular blocker (to enable     insertion of a tube through the nose or mouth into the trachea to provide artificial     ventilation). The intubating dose was followed by repeated bolus maintenance doses as needed,     to maintain muscle relaxation. The time it takes to reach maximal effect of the neuromuscular     blocker (onset time) after the intubating dose was measured and compared as the primary     outcome.   "
238565|NCT00970775|"     This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel     group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following     single ascending dose administration to healthy Japanese subjects.   "
238566|NCT00970788|"     A randomized controlled trial of a video decision aid in 50 patients with advanced brain     cancer.   "
238567|NCT00970801|"     The incidence of pulmonary disease caused by nontuberculous mycobacteria (NTM) has been     increasing, and a substantial proportion of these patients have no preexisting lung disease     and no demonstrable immunodeficiency. These patients are predominantly nonsmoking elderly     women. High-resolution computed tomography scans revealed the characteristic findings of     multifocal bronchiectasis combined with multiple small nodules. NTMs are ubiquitous     environmental organisms. Because exposure to these organisms is universal and the occurrence     of the disease is rare, normal host defense mechanisms must be effective enough to prevent     the infection.      All patients with NTM lung disease do not need to receive long-term antibiotic treatment. As     the American Thoracic Society guidelines point out, one of the most difficult questions may     be when to start antibiotic therapy in patients with NTM lung disease. The decision to begin     treatment is made by weighing the anticipated benefits and risks. The decision is relatively     easy in patients with profound symptoms and destructive lesions; however, the decision is     difficult in patients with mild symptoms and non-advanced lesions. Factors that must be     considered include the patients' age, whether the symptoms are mild or equivocal, and the     presence of comorbidities. In all cases, close observation is necessary if treatment is not     performed. However, few studies have shown that patients with certain characteristics show     disease progression.      The treatment of NTM pulmonary disease depends on the infecting species, but decisions     concerning the institution of treatment are never easy. Treatment requires the use of     multiple drugs for 18 to 24 months. Thus, treatment is expensive, often has significant side     effects, and is frequently not curative. Therefore, clinicians should be confident that there     is sufficient pathology to warrant prolonged, multidrug treatment regimens. In all of the     situations, outcomes can be best optimized only when clinicians, radiologists, and     laboratories work cooperatively.      This study will examine why some people are more susceptible to NTM lung disease and why some     people of NTM lung disease are more difficult to treat. This study will examine the patient     and bacterial characteristics, course of disease and treatment of NTM infections, as well as     the genetics involved in these infections.      Patients with diagnosed NTM lung disease may be eligible for this study. All participants     will have a medical and family history, blood tests, imaging studies that may include X-rays,     computed tomography (CT) scans, and genetic and serologic studies. The aim of this study is     to identify patient and bacterial characteristics that contribute to disease susceptibility,     disease progression, and treatment failure. Subjects are recruited from among patients who     are diagnosed to have NTM lung disease at the Samsung Medical Center in the Republic of     Korea.   "
238568|NCT00970814|"     The primary objectives of this study are to assess the efficacy of levetiracetam XR in     increasing the percentage of subjects with no heavy drinking days and in reducing the weekly     percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV     criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more     drinks per drinking day for women (designated as very heavy drinkers).   "
238569|NCT00970827|"     Angioplasty is a commonly performed procedure for treating blockage of the blood vessels in     the heart. Although this procedure is usually successful, it is often accompanied by a small     degree of damage to the heart (i.e., small heart attack).      The purpose of this study is to find out if inflating a blood pressure cuff on the arm or the     leg at the time of angioplasty for several minutes has a beneficial effect.      Patients will be assigned to one of three treatment groups: inflating blood pressure cuff on     the arm, inflating blood pressure cuff on the leg and a control group.   "
238570|NCT00970840|"     Inadequate micronutrient intakes during pregnancy, lactation and infancy remain a major     problem in Ghana. Lipid-based nutrient supplements (LNS) made using vegetable oil, groundnut     paste, milk, sugar, and micronutrients may offer a solution.      The proposed study will test the acceptability of a lipid-based nutrient supplement designed     for infants (LNS-20gM) and another designed for pregnant and lactating women (LNS-P&L).     Participants will consume a test meal consisting of LNS-20gM (20 infants) or LNS-P&L (20     pregnant and lactating women) mixed with fermented maize porridge, after which they will be     given the respective LNS supplement for use at home for 14 d. Primary outcome is the     proportion of the test-meal consumed. The investigators hypothesize that subjects will     consume at 75% of the test meal offered.   "
238571|NCT00970853|"     Study measures will evaluate cognitive, academic, and behavioral outcomes for the children,     school services received, and caregiver stress and depression. The main study outcome     measures include cognitive status, school functioning, and behavior. Long-term outcomes will     be studied in attempt to verify the 33 and 60 month significant differences found in school     participation and behavior between the intervention and control groups.   "
238572|NCT00970866|"     In Ghana, low micronutrient intakes among pregnant women are a major problem. The standard     nutritional intervention during pregnancy is iron-folic acid tablets, but adherence is low.     The investigators have pioneered the use of multiple micronutrient-fortified semi-solid     pastes called Lipid-based Nutrient Supplements (LNS) (made using vegetable oil, groundnut,     milk, sugar, and micronutrients), and the investigators' previous studies show that the     approach could have great potential for use by pregnant and lactating women.      This study aims to evaluate the effects of LNS-P&L designed for pregnant and lactating women     and LNS-20gM designed for infants. Pregnant women (n=864) randomly selected from ante-natal     clinics in Yilo and Manya Krobo districts of Ghana will be randomized to receive daily (a)     Group 1: Iron/ Folic Acid tablets during pregnancy, and a tablet containing calcium (Ca) only     (akin to a placebo) during lactation (6 mo), (b) Group 2: Multiple Micronutrient tablets     during pregnancy and the first six months of lactation, or (c) Group 3: LNS-P&L during     pregnancy and lactation, whilst their infants receive LNS-20gM daily from 6 to 18 months.     There are two primary outcomes namely:        1. Maternal primary outcome: Birth length        2. Child primary outcome: Child length-for-age z-score at 18 mo.      The investigators hypothesize that a) mean birth length and length-for-age at 18 mo will be     greater in children whose mothers are in Group 2 than those whose mothers are in Group 1, and     b) children whose mothers are in Group 3 will have greater birth length and length-for-age at     18 mo than the children in either of the other two groups.   "
238573|NCT00970879|"     The purpose of this study is to evaluate the efficacy of cotrimoxazole prophylaxis in     prevention of malaria during pregnancy in HIV-infected women, compared to intermittent     preventive treatment with mefloquine.   "
238574|NCT00970892|"     The investigators aimed to use pharmacogenetic information in clinical practise which may     lead to rapid, efficient, and safe warfarin dosing in this observational prospective study.     In this context, the investigators plan to develop an algorithm for estimating the     appropriate warfarin dose that is based on both clinical and genetic data from the Turkish     study population. This study is unique not only investigating clinical factors, demographic     variables, CYP2C9, and VKORC1 gene variations which contribute to the variability among     patients in dose requirements for warfarin but also including thrombogenic single nucleotide     polymorphisms (SNP) in the same patient population. Thus, warfarin would be a good example by     being the first cardiovascular drug for pharmacogenetic guided personalized medicine     applications.   "
238575|NCT00970905|"     Severe nausea and/or vomiting in patients receiving radiotherapy to the upper abdomen is     common despite having received pre-medication with ondansetron, a standard preventive     treatment. This study aims to reduce the incidence of significant nausea and/or vomiting with     the addition of the NK1-antagonist aprepitant to standard ondansetron treatment. This study     will also assess the safety and tolerability of prolonged administration of aprepitant over     the 4 to 6 week period of radiation treatment.   "
238576|NCT00970918|"     The purpose of this study is to obtain the distribution of measurements of the intima media     thickness of carotid arteries in people with high cardiovascular risk.   "
238577|NCT00970931|"     The incidence of hypertension in individuals with pre-hypertension was 80% in ten years in a     study conducted in Southern Brazil. The effectiveness of non-drug interventions to prevent     hypertension is low in the long term. It may be hypothesized that a population-based drug     intervention could reduce relevantly the burden of hypertension and cardiovascular disease.      Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well     tolerated, have longer duration of action and the advantage of very low cost to be used in a     population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is     to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized     by a potassium-sparing diuretic, as amiloride.      A study with this objective is therefore recommendable in Brazil, in order to support a plan     of precocious intervention in individuals with pre-hypertension. Such a study was demanded     and funded by the Health and Technology Ministries in Brazil.   "
238578|NCT00970944|"     This is a controlled trial of amantadine to improve level of function following severe     traumatic brain injury.      The purpose of this study is:        1. To determine whether amantadine hydrochloride, given in a dose of 200-400 mg, improves          functional recovery from the vegetative and minimally conscious states        2. To determine whether amantadine-related gains in function persist following drug          discontinuation        3. To determine the safety profile of amantadine in patients with disorders of          consciousness   "
238579|NCT00970957|"     Lack of an effective treatment for macular edema secondary to central retinal vein occlusion     and the bad response to grid laser treatment in patients with macular edema secondary to     branch retinal vein occlusion, together with the high incidence of the pathology and the     great functional loss in the patients that suffer from it has motivated the search for new     therapeutic approaches.      In recent times, intravitreal bevacizumab has been tested in clinical practice in small     series of patients with this pathology, whether as first treatment or after failure of grid     laser treatment with good functional results in short series.      However, no retreatment information is available, although preliminary results from published     series are good.   "
238580|NCT00970970|"     Von Hippel Lindau disease (VHLD) is an inherited syndrome characterized by vascular     malformations, kidney cancer, adrenal gland and pancreas tumors. The VHL protein is not     functional in the different disease associated lesions which results in production of high     amounts of vascular endothelial growth factor (VEGF). Currently there are no clinical,     radiographic or molecular markers that can predict the natural history of a given lesion.     With 89Zr-bevacizumab positron emission tomography (PET) scanning, VEGF can be visualized and     quantified.      The investigators hypothesize that 89Zr-bevacizumab PET imaging is a useful tool to predict     the behaviour of disease associated lesions in patients with VHLD.      Adult patients with VHLD who have had routine magnetic resonance imaging (MRI) scans of     central nervous system (CNS) and abdomen will undergo a 89Zr-bevacizumab PET scan. MRI will     be repeated within 12 months.   "
238581|NCT00970983|"     The purpose of this study is to evaluate the disease free and overall survival of patients     with breast carcinomas of small size, i.e., not greater than 2.0 cm and with clinically non     palpable axillary lymph nodes, undergoing either conservative surgery and axillary     dissection, or a similar treatment for the primary tumor and rapid analysis of the sentinel     lymph node, the result of which determines axillary node dissection or its avoidance is     based.   "
238582|NCT00970996|"     The goal of this clinical research study is to find the highest tolerable dose of Abraxane     (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon     alfa-2b, and interleukin-2 (IL-2) to patients with metastatic melanoma.      Primary Objective:        -  The primary objective of the Phase I is to determine the toxicity, safety and the          maximum tolerated dose maximum tolerated dose of Abraxane in combination with Cisplatin,          Temozolomide, interleukin-2 and interferon a2b in patients with metastatic melanoma.      Secondary Objectives:        -  To assess responses to the combination.        -  To evaluate the duration of response and the overall survival.        -  To determine the effectiveness in delaying the appearance of Central Nervous System          disease.   "
238583|NCT00971009|"     Being diagnosed and treated for cancer is usually associated with severe physical symptoms,     impaired functional status, complex emotional, psychosocial and existential issues and     substantial worries. Failure to help patients with their problems and worries can     unnecessarily delay patients' recovery and rehabilitation, lead to chronic functional     impairments, anxiety and depression and prolong patients' needs for health care and social     services. The objectives of this interdisciplinary, international research project that     includes collaboration with HELFO (The Norwegian Health Economy Administration), are to test     and compare, in a randomized, controlled trial (RCT), the effects of (1) a     practice-integrated online patient-provider communication (OPPC) service including access to     asking questions to HELFO, (2) a multi-component Interactive Health Communication Application     (IHCA) called WebChoice, and (3) usual care on: patient outcomes, health care and social     services use and costs. Breast cancer patients undergoing treatment at three different     hospitals in Norway will be randomized into two experimental and one control groups and will     be followed with 5 repeated measures over one year. The proposed study will contribute to     innovative methods and technologies that can radically improve patient-provider     communication, care quality, and continuity of care. The two interventions tested in this     study, the OPPC service with and without additional features of WebChoice, represent new     forms of interactions and information sharing between patients and clinicians where patients     can get seamless access to communication and information services from where and whenever     they need it. This could significantly contribute to reducing unnecessary suffering, less     fragmented health care, better efficiency, patient safety, patient satisfaction and have an     impact on patients' health services utilization. The investigators' work addresses,     therefore, important health policy goals with the potential for considerable societal gains.   "
238584|NCT00971022|"     The goal of this study is to learn about the factors that influence people to take part in     discount generic prescription programs.      The primary objective of this study is to identify the factors associated with awareness and     utilization of discount generic prescription programs and how two low-income populations in     Houston utilize the $4 for a 30-day supply or $10 for a 90-day supply, Generic Prescriptions     Program offered by Kroger, Randalls, Target, Walmart, HEB, CVS, and Walgreens.   "
238585|NCT00971035|"     This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The     purpose is to evaluate the relationship between the dose of lebrikizumab and the response in     terms of the efficacy, safety, and tolerability in patients with asthma who are not on     inhaled steroids.   "
238586|NCT00971048|"     To compare HP828-101 to standard of care for the management of partial or full thickness     wounds   "
238587|NCT00971061|"     The purpose of this study is to investigate the efficacy and safety of the Ahmed valve     implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma     during a follow-up period of 24 months.   "
238588|NCT00971074|"     The investigators' objective is to analyze a group of patients who have had a partial     meniscectomy but continue to have knee pain after surgery with a double-blind, randomized     prospective study comparing the use of Hylan G-F 20(single injection of a     viscosupplementation) versus placebo injection. The investigators would expect patients who     receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in     the placebo group (had the needle injected into the knee but no medication or substance     injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.   "
238589|NCT00971087|"     The purpose of this image acquisition study is to compare, in a Reader Study, the     Tomosynthesis System used in conjunction with a conventional 2-D digital imaging system (2-D     plus 3-D images) to the conventional 2-D digital imaging system (2-D images), and to     determine whether the 2-D plus 3-D images compared to the 2-D images alone will improve     receiver operating characteristic (ROC) area under the curve.   "
238590|NCT00971100|"     The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate     immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new     swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and     adolescents. A booster dose will be administered 12 months after the first vaccination.   "
238591|NCT00971113|"     The human intestinal microflora is characterized as a complex and dynamic microbial ecosystem     with crucial contribution to our nutrition and welfare. Health-promoting genera such as     Bifidobacterium spp. and Lactobacillus spp. play a key role in digestion of nutrients,     production of short chain fatty acids and vitamins, inhibition of harmful bacteria,     immunostimulation, reduction of blood cholesterol and ammonia levels and restoration of     normal flora after antibiotic therapy. Proteolytic species such as toxin-producing clostridia     and toxigenic E. coli are considered as potential pathogens with detrimental effects to human     host.      Recently, part of novel food research is directing towards the concept of prebiotics e.g.     food ingredients that are not hydrolyzed by the human gastrointestinal tract and beneficially     affect the host by selectively stimulating the growth and/or activity of one or limited     number of bacteria in the colon that can improve host health.      Fructo-oligosaccharides and inulin, are considered as the most extensively studied and     well-established prebiotics. In vitro and in vivo data suggest the bifidogenic effect of     inulin and oligofructose, which can be attributed to their selective fermentation by     Bifidobacterium species. Due to their documented prebiotic properties, both inulin and FOS     are increasingly applied in novel food product development through the fortification of     commonly ingested foodstuffs.      The aim of this study is to evaluate the in vivo prebiotic effect of a functional food     containing short-chain fructo-oligosaccharides (sc-FOS) and Sideritis euboea extract on the     faecal microflora composition of healthy human volunteers.   "
238592|NCT00971126|"     The purpose of this phase I study is to determine the maximal tolerable dose (MTD) of     thalidomide (THADO®) in combination with fixed dose of sorafenib (NEXAVAR®) for the treatment     of advanced or metastatic HCC.      The Phase II purpose of this study is to determine the disease control rate (complete     response + partial response + stable disease) for at least 4 months of sorafenib (NEXAVAR®)     plus phase I determined MTD of thalidomide (THADO®) in patients with advanced or metastatic     HCC.   "
238593|NCT00971139|"     This interdisciplinary, international collaboration study, including the the Norwegian Health     Economy Administration (HELFO) will evaluate the effectiveness and real-world implementation     of an online patient-provider communication (OPPC) service into rout ine practice. In Phase I     we will identify patients and care providers requirements and organizational contexts, and     use participatory design methods to adapt the OPPC service to users needs and the context of     clinical practice. In Phase II we will offer study participants access to the OPPC service to     understand implementation issues. In addition, we will conduct a pilot randomized clinical     trial (usual care; OPPC) with 40 patients in each group that will be followed over 6 months.   "
238594|NCT00971152|"     This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where     a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily     dose is administered for women who are at risk of a poor ovarian response in order to     determine if one dose or the other results in improved cycle outcomes.   "
238595|NCT00977327|"     Purpose:        -  Improvement of extent of resection by the use of intraoperatively acquired image data          sets to navigate.        -  Better define the role of different intra-operative imaging modalities, used to update          the navigational data set, in aiding the surgeon during resection of intra-axial brain          lesions.        -  To examine the cost-effectiveness of different intraoperative navigational systems as a          function of operative time and Operative time (Surgery including imaging)      There is increasing neuro-oncological evidence that extent of resection might have an impact     in particular in low-grade lesions.   "
238596|NCT00977340|"     The purpose of this study is to determine whether a change in the content of nightmares is     necessary at all in the treatment of chronic nightmares or if a single confrontation with     their content is sufficient to reduce nightmare frequency significantly.   "
238597|NCT00977353|"     Major depressive disorder is a complex disease and most currently available antidepressants     aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects.     N-methyl-D-aspartate (NMDA), one subtype of glutamate receptors, plays an important role in     learning and memory. N-methyl-D-aspartic acid (NMDA) enhancing agents, such as sarcosine     (N-methylglycine), have been used as adjunctive therapy of schizophrenia. Sarcosine improved     not only psychotic but also depressive symptoms in patients with schizophrenia. To confirm     its antidepressant effect, the purpose of this study is to compare citalopram and sarcosine     in efficacy for major depressive patients.   "
238598|NCT00977366|"     Central sensitisation is an increase in the excitability of nerves within the central nervous     system, which can lead to heightened sensitivity to certain stimuli. This process is involved     in some chronic pain conditions e.g. migraines and non−cardiac chest pain. Recent work by our     group suggests central sensitisation may be an important mechanism leading to chronic cough.      The main questions in this study include:        1. Can the investigators induce temporary central sensitisation of the cough reflex in          healthy volunteers for testing of new medications?        2. Can the investigators demonstrate exaggerated sensitisation in patients with chronic          cough (indicating these patients are already centrally sensitised)?      In animal studies, acid infusion into the gullet (oesophagus) is able to induce central     sensitisation of the cough reflex. Acid infusion into the oesophagus has also been shown to     induce central sensitisation in human healthy volunteers, increasing the sensitivity to pain     on the front of the chest but this study did not test the the cough reflex. Using human     participants, the investigators plan to test whether acid infusion into the oesophagus     increases the sensitivity of the cough reflex in healthy volunteers and also patients     complaining of chronic cough.   "
238599|NCT00977379|"     This open-label, randomized, parallel arm study will evaluate the effect of capecitabine     administered concurrently with WBRT and as maintenance therapy in participants with breast     cancer and newly diagnosed brain metastases. Participants will be randomized to receive     either capecitabine with 10 days standard WBRT, or WBRT alone. Maintenance therapy will     follow with capecitabine or another systemic therapy in the WBRT only group.   "
238600|NCT00977392|"     RATIONALE: Women who do not undergo routine cervical screening may be more likely to collect     a self-sample for human papillomavirus testing.      PURPOSE: This randomized clinical trial is studying self-sampling in women who do not undergo     routine cervical screening.   "
238601|NCT00977405|"     The investigators' hypothesis is that placement of CollatampG in the subcutaneous layer of     contaminated abdominal wounds is effective prophylaxis for superficial surgical site     infection (SSI). CollatampG is composed of highly purified type 1 collagen obtained from     bovine tendon, which acts as a vehicle for the aminoglycoside antibiotic, gentamicin. This     implant provides a high concentration of local gentamicin at the surgical wound to decrease     the local microorganism load. It has been shown that if a surgical site is contaminated with     > 10 to the power of 5 microorganisms per gram of tissue, the risk of infection is markedly     increased. When a gastrointestinal organ is the source of pathogens, gram-negative bacilli     (e.g., E. coli) are typical isolates, which are susceptible to gentamicin. Therefore, a high     local concentration of gentamicin at the contaminated surgical wound provided by the     CollatampG implant may prevent the local bacterial load from reaching levels high enough to     cause a clinical infection.   "
238602|NCT00977418|"     Seniors 65 years of age and older represent one of the fastest growing segments of society     with the population doubling within the next 25 years with dramatic rates of mental decline,     costing society billions of dollars each year. The proposed research seeks to discover     whether relatively short term mental or physical training can enhance gist reasoning,     generalize to untrained cognitive areas and modify/strengthen brain function in areas     susceptible to aging processes. To identify neuroprotective and non-pharmacological     interventions to prevent mental decline and maximize cognitive brain health during the course     of the adult lifespan has major public policy implications.   "
238603|NCT00977431|"     This study is a phase I, open label trial to determine the Maximum Tolerated Dose (MTD),     safety, pharmacokinetics, and efficacy of BIBW 2992 (an epidermal growth factor     receptor(EGFR)inhibitor) to be used in combination with:        -  radiotherapy alone (in patients with an unmethylated (functioning) MGMT gene regulator)          or        -  radiotherapy and Temozolomide (in patients with a methylated (silenced) MGMT gene) to          treat newly diagnosed patients with Grade IV Glioblastoma (primary brain cancer).   "
238604|NCT00977444|"     Abstract      Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This     study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of     knee.      A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried     out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly     injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8     mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will     be the change from baseline to final assessment in the Western Ontario and McMaster     University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.   "
238605|NCT00977457|"     This trial studies the side effects and best way to perform genetic testing in predicting     biomarkers of recurrence in patients with prostate cancer undergoing surgery. Collecting and     storing samples of tissue, blood, and other body fluids from patients to test in the     laboratory and collecting information about the patient's health and treatment may help     doctors learn more about cancer and help predict the recurrence of prostate cancer   "
238606|NCT00977470|"     The purpose of this research study is to learn if adding hydroxychloroquine (HCQ) to     erlotinib helps treat non-small cell lung cancer (NSCLC). Another goal of this research study     is to learn more about NSCLC and how it may respond to study treatment. Erlotinib (Tarceva)     is a type of drug called a tyrosine kinase inhibitor (TKI). TKIs block a protein called the     epidermal growth factor receptor (EGFR). EGFR may control tumor growth and tumor cell     survival. However, although TKI drugs can work for some lung cancer patients for a period of     time, eventually the tumor finds a way to resist or counteract the TKI treatment and it     begins to grow again. Hydroxychloroquine (HCQ) is a drug approved by the FDA for treating     malaria, rheumatoid arthritis, and several other diseases. Laboratory research suggests that     when HCQ is given with a TKI, it may help delay or prevent TKI resistance from developing.   "
238607|NCT00977483|"     To assess clinical efficacy and safety of long-term orally administered thioctic acid in the     treatment of diabetic polyneuropathy.   "
238631|NCT00979394|"     This registery should show the medical care of patient with Type 2 Diabetes (T2D) at     GP-offices. Furthermore data of co morbidities and risk factors should be evaluated.     Objectives of this NIS (cross-sectional study) are:        -  To evaluate which characteristics or co-morbidities are being existent for patient with          T2D at GP level,        -  To evaluate representative profile of patient with T2D in Austria,        -  To evaluate which medical therapies are used.   "
238608|NCT00977496|"     The goal of this study is characterize the changes in bacterial diversity of the nares of     hemodialysis patients. Another goal is to determine when hemodialysis patients become     colonized with the bacteria Staphylococcus aureus, as nasal colonization with S. aureus is a     major risk factor for invasive infection in hemodialysis patients. Fifteen subjects will be     recruited into the study. Nasal swabs will be collected every month for six months or until     one month after S. aureus colonization in order to determine any changes in the bacterial     communities of the nose. Clinical data will also be collected to evaluate the possible     influence of external factors on changes in the microbial communities in the patients' noses.     This study will provide preliminary data on whether oral- and/or nasal-administered     probiotics can eliminate nasal carriage of S. aureus.   "
238609|NCT00977509|"     To compare the frequency of individual genetic abnormality between tumor cells and blood     specimens.   "
238610|NCT00977522|"     This study is examining the efficacy of PF-03463275 compared to placebo in treating negative     symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients     with schizophrenia.   "
238611|NCT00977548|"     The purpose of this research study is to find out what effects, good and/or bad, erlotinib     has on the patient and their myelodysplastic syndrome. Erlotinib has been approved by the     Food and Drug Administration (FDA) to treat non-small cell lung cancer; however, erlotinib     use in this study is considered investigational as the FDA has not approved it for the     treatment of myelodysplastic syndrome.   "
238612|NCT00977561|"     This study will summarize the safety of patients receiving figitumumab combined with     etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or     carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung     Cancer.   "
238613|NCT00977574|"     This randomized phase II trial studies paclitaxel, carboplatin, and bevacizumab or     paclitaxel, carboplatin, and temsirolimus or ixabepilone, carboplatin, and bevacizumab to see     how well they work in treating patients with stage III, stage IV, or recurrent endometrial     cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ixabepilone, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the     ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. It is not yet known which treatment     regimen is most effective in treating patients with endometrial cancer.   "
238614|NCT00977587|"     Irritable Bowel Syndrome (IBS) is a common condition characterised by abdominal pain or     discomfort and altered bowel habit affecting up to 10% of the population. There are several     groups of patients that are based on differing bowel patterns including IBS with diarrhea     (IBS-D) and those with post infective IBS (PI-IBS) whose symptoms begin after an acute     infection. Saccharomyces cerevisiae, the yeast used in bread making has been shown to reduce     the duration of infectious diarrhoea. Part of the benefit maybe that it can destroy bacterial     toxins. Recent studies suggest an increase in proteases (chemicals which breakdown proteins)     in the stool of patients with IBS-D. The investigators think that this yeast may benefit     patients with IBS-D and PI-IBS by reducing the amount of protease in stool. This is important     because proteases have been shown to be potentially important in generating some of the     discomfort experienced by patients. The investigators will study patients with chronic IBS-D     who will receive 2 weeks treatment with the yeast or placebo followed by a 4 week gap and     then a further 2 week treatment with placebo or the yeast, with the treatments allocated     randomly. The investigators will also study 30 subjects who still have persistent loose bowel     function 6 weeks after an infection with Campylobacter jejuni, one of the commonest causes of     gastroenteritis in the UK. Subjects will be randomised to take either the yeast or placebo     for 4 weeks . In both studies, the investigators will examine the effect of treatment on     stool proteases, stool frequency and consistency and abdominal discomfort; the investigators     will also take blood samples to examine some aspects of immune system function. The results     of the study may suggest how yeast provides a benefit in patients with IBS and diarrhea and     will provide data for a larger clinical trial.   "
238615|NCT00977600|"     To determine the safety and tolerability of single oral doses of HPN-100 as a formulation     (GT4P-F) and GT4P as the active pharmaceutical ingredient (GT4P-API) administered to healthy     male subjects.   "
238616|NCT00977613|"     Given the apparent effect of 18 metabolic equivalent task-hours of activity/week in improving     disease free survival in patients with treated stage 3 colon cancer and the survival benefit     of exercise demonstrated in patients with stage II and III colorectal cancer, the primary     objective is to evaluate compliance at 6 months with post-treatment recommendations for a     minimum of 18 metabolic units of physical activity each week in patients who have completed     therapy for stage 2 and stage 3 colorectal cancer.   "
238617|NCT00977626|"     Three-part study investigating the safety and tolerability of AZD2423 multiple doses in 98     healthy volunteers: Part 1 80 young and elderly subjects in a parallel, double blind,     randomised study. Part 2 - 6 subjects in an open, non-randomised study. Part 3 - 12 subjects     in a three-way cross over, open label, partially randomised study.      Part 1 has 2 Arms, AZD2423 or Placebo, Multiple dosing during 10-14 days . Part 2 has 1 Arm     AZD2423 Multiple dosing and Part 3 has 3 Arms AZD2423 single dosing or AZD2423 single dosing     with food or AZD2423 single dosing, Fasting Condition   "
238618|NCT00977639|"     The pathworks tissue of origin test is a microarray-based test with the goal of identifying     the tissue of origin in patients with metastatic tumors of unknown primary site.   "
238632|NCT00979407|"     The primary purpose of the study is to assess the equivalence of the immune response elicited     by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and     GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate     the safety and reactogenicity of these two vaccines.   "
238633|NCT00979420|"     The question that prompted this study is the extent to which results from clinical trials can     be translated into everyday practice (external validity). An observation period of about 10     years extends far beyond the duration of clinical trials. First and foremost are questions     about tolerability and the efficacy of an antiretroviral combination treatment with Viramune     and other antiretroviral partners. In particular, adverse events will be recorded and the     therapeutic effect will be monitored via the course of viral load and improvement of the     immune system, based on the CD4 cell count.   "
238634|NCT00979433|"     The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in     a greater proportion of infants being successfully extubated when compared with management     with ventilator derived CPAP.   "
238809|NCT00974012|"     This study was designed to compare the relative bioavailability (rate and extent of     absorption) of Divalproex Sodium ER Tablets 500 mg with that of Depakote® ER Tablets 500 mg     following a single, oral dose (1 x 500 mg extended release tablet) administered to healthy,     adult subjects under non-fasting conditions.   "
238619|NCT00977652|"     Fecal incontinence is a major public health issue since 10% of the French population aged 45     has to deal with it. Different treatments exist and have already been evaluated, like the     sacral nerve stimulation (SNS) which has proved to be efficient in 75 to 100% of the anal     incontinence patients without significant sphincteric lesions or rectal prolapse. However,     the treatment is expensive and can have side effects. Moreover, about 20 to 30% of the     patients can develop a resistance to the SNS only a few months following the definite     implantation. Yet the development of the posterior tibial nerve stimulation (PNTS) offers a     new perspective. It consists in stimulating the same metameric area as the sacral nerves. It     is regularly used for the treatment of urinary incontinence caused by overactive bladder. It     is a non-invasive technique, causing but a few side effects. A preliminary study showed that     7 in 10 incontinent patients saw an improvement when treated with PTNS.      Purpose:      The aim of this study is to analyse and evaluate the PTNS technique in the short term as a     treatment of anal incontinence. It is done through the means of a multi-centric prospective     randomized study.      Patients:      Will be included: all patients followed for anal incontinence (either with liquid or solid     stools) having at least one accident a month for 3months, and who are not diagnosed with     colorectal lesions and who are without anal or rectal significant anatomic anomalies, without     rectal prolapse, and who have failed to respond to medical treatment (such as medicine or     perineal reeducation). The main criterium to analyze the efficiency will be the number of     fecal incontinence episodes on a bowel diary. The investigators aim to incorporate 144     patients, that is 72 in each group. 12 centers will take part in this study, that will last 2     years and 3 months. They are the centers of: Bordeaux, Clermont-Ferrand, Grenoble, Lyon,     Marseille, Nancy, Nantes, Paris, Diaconesses-Croix,Paris Rothschild, Rennes, Rouen, and     Toulouse.      Method:      The PTNS consists in setting two electrodes on the posterial tibial nerve pathway. The     electrodes are connected to an external stimulator. After having drawn lots, patients will be     treated for 3months either with effective stimulation (frequency: 14hz; impulse duration:     210usec;intensity:sensibility threshold), or with shame stimulation (intensity: 0mAmp). There     will be two daily sessions of stimulation (effective, or shame), 20 min each. A pre-treatment     assessment will be established, composed of a stool diary, a Cleveland Clinic score, a Fecal     Incontinence Quality of Life scale and an anorectal manomety, that will all be repeated by     the end of the treatment.      Expected Results:      The investigators hope to prove the short term efficacy of the PTNS on anal incontinence     patients.   "
238620|NCT00977665|"     To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.   "
238621|NCT00979264|"     The objective of this study is to evaluate whether a quarterly feedback, education and     performance improvement site-based intervention has a greater impact on quality performance     and adherence to evidenced-based guidelines than existing on-demand feedback. This study will     use a randomized design to compare changes in quality performance and adherence to selected     measures among hospitals using existing on-demand reports and general quality improvement     (QI) efforts versus those receiving intensive, targeted QI feedback via reports,     teleconferences, webinars, and specialized tool kits.   "
238622|NCT00979277|"     Recent studies from both human and mice cancer models have demonstrated a crucial role for     monocytes/macrophages in contributing to cancer progression and disease prognosis. However,     since each cancer subtypes is associated with a unique tumor microenvironment in terms of its     anatomical location, cytokine/chemokine profiles and stromal components, the functional     contribution of tumor infiltrating cells such as the monocytes/macrophages can be equally     diverse, depending on the type of cancer. Therefore to obtain a global understanding of the     role of host immune cells in cancer progression, it is necessary to accurately characterize     these cells in the context of the tumor microenvironment for several cancer subtypes rather     than a single cancer. In view of this, this pilot proposal aims to carryout a systems     approach in characterizing the functional phenotype of monocyte/macrophage lineage in 4     diverse human cancer types [e.g., Colorectal Cancer, Nasopharyngeal carcinoma, Hepatocellular     (liver) cancer and Renal cell carcinoma (kidney cancer)] and the molecular basis of     tumor-induced immunosuppression in each of these conditions. Besides providing a global view     of the host innate immunity and its molecular basis in these human cancer, the outcome of     this investigation will be crucial in defining the scopes of specific immunotherapy     strategies to overcome tumor-induced immunosuppression and induce     monocyte/macrophage-mediated antitumor response.   "
238623|NCT00979290|"     The fixed-dose combinations (FDC) with two or more antituberculous drugs in one capsule or     tablet are available to prevent the development of drug resistance. However, the fixed-dose     combination regimen is not consistent with the dosages that are usually given. The present     available FDC chemotherapy (Rifater) for pulmonary tuberculosis that is used in Taiwan has a     higher ratio of isoniazid to rifampin and pyrazinamide. The higher risk of drug toxicity and     adverse reactions when using fixed-dose combinations regimen should be considered. The aim of     the present study is to compare the toxicity between using FDC regimen (Rifater/Rifinah) in     Taiwan and single drugs in the treatment of newly diagnosed pulmonary tuberculosis. The     investigators also evaluate the efficacy of two regimens and determine the incidence of     discontinuation of TB drugs and the predisposed factors between two regimens.   "
238624|NCT00979303|"     The purpose of this study is to determine whether the additional use of non-fluoroscopic     imaging modalities can decrease the use of radiation exposure during standard ablation     procedures for supraventricular tachycardia (SVT) in children.   "
238625|NCT00979316|"     The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT     interval corrected for heart rate).   "
238626|NCT00979329|"     The purpose of this study is to assess the influence of Sunitinib and Sorafenib on fatigue,     quality of life and depression in patients with metastatic renal cell or colorectal cancer or     GIST. In order to get more insight in the mechanism of vascular endothelial growth factor     (VEGF) related fatigue and if possible to come to a resolution for this side effect.   "
238627|NCT00979342|"     The purpose of this study is to develop a recommended local anesthetic protocol and     post-treatment pain management regimen, in order to assure patient comfort during     office-based treatment with the MyoSure Hysteroscopic Tissue Removal Device. Subject     self-reported pain scores (as rated on an 11 point scale) will be compared at multiple time     intervals between all treatment groups.   "
238628|NCT00979355|"     A feasibility trial to evaluate the usefulness of a high efficiency camera (D-SPECT) as an     imaging modality for general nuclear medicine applications such as oncology.   "
238629|NCT00979368|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics     following single oral doses of BMS-816336 in healthy male subjects.   "
238630|NCT00979381|"     In this study the researchers investigate the influence of the tyrosine kinase inhibitors     sunitinib and sorafenib, on the normal humoral and cellular immuno response to influenza     vaccination in patients with metastases of renal cell carcinoma or a GIST.   "
238647|NCT00979615|"     The purpose of this study is to examine safety and efficacy of Patanase and Astelin in     treating the symptoms of non-allergic vasomotor rhinitis (VMR).   "
238635|NCT00979446|"     Numerous modifiable lifestyle factors have been identified that may affect the risk of older     adults developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Evidence     suggests that interventions to reduce risk factors and enhance protective factors would be     beneficial in slowing cognitive decline and decreasing the risk of incident MCI and AD. The     overall objective of this pilot study, funded as a supplement to Keep Active Minnesota (KAM)     (03-024; R01-AG023410) is to develop and test the feasibility of conducting a multi-domain     intervention to maintain cognitive health in adults ages 60-80 with the goal of reducing the     incidence of and slowing progression to MCI and other more severe forms of cognitive decline.   "
238636|NCT00979459|"     This study will assess the pharmacokinetics of two formulations of MK-1006. The primary     hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum     concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and     film coated tablet (FCT) formulations of MK-1006 will be similar.   "
238637|NCT00979472|"     The purpose of the study is to compare the effect of solifenacin succinate between frequent     micturition patients with urgency and those without urgency.   "
238638|NCT00979485|"     The purpose of this study is to provide data correlating levels of microparticles that     circulate in the blood and disease activity in children with inflammatory bowel disease     (IBD). The hypothesis is that circulating microparticles will be higher in children with     active IBD, show inflammatory activity, and will be low in patients in remission as well as     in healthy controls.   "
238639|NCT00979511|"     Osteoporosis has been described as a paediatric disease with a geriatric outcome. This is     because bone mass is acquired during youth and is progressively lost later in life, without     symptom or pain, until a fracture occurs. The proper management of osteoporosis includes     improving bone mineral content in the first two decades of life so that reserves are built up     before bone loss ensues.      The investigators aim to determine the effect of a 10-month school-based provision of     high-calcium milk and weight-bearing exercise program on the bone mineral status among     prepubertal girls. The investigators' study is novel since it seeks to determine the effect     of these interventions in girls, whose overall risks are much higher for osteoporosis later     in life, and in a developing country population whose calcium intakes are more likely to be     depleted.      The investigators hypothesize that provision of either high-calcium milk or weight-bearing     exercises will improve bone mineral density among prepubertal girls but that the bone accrual     will be greater among those with both interventions. In addition, the investigators     hypothesize that the changes will be more marked among those whose calcium intakes are lower.      This study will use a two-by-two factorial design of 1) high-calcium milk (1000 mg/day) vs.     placebo (115 mg/day) and 2) weight-bearing exercises (a total of 90 to 150 minutes per week     divided into 3 to 5 schooldays) vs. no-exercise (passive activities) in a randomized     controlled trial, for a total of 4 intervention groups: calcium+exercise, placebo+exercise,     calcium+no exercise, placebo+no exercise.      The study will be conducted among 80 prepubertal girls (on Tanner stage 1), aged 7-9 years     and enrolled in one primary school in one of the metropolitan cities in the Philippines with     an institution or a hospital with a Lunar Prodigy Central dual-energy x-ray absorptiometry     (DEXA) machine.      Osteoporosis has no treatment. The problem will continue to become burdensome in the future     since population aging per se will increase the risk and incidence of fractures.     Understanding the relationship between calcium and exercise is important since the greatest     benefit is in the paediatric age range. The study results could provide information on a     workable intervention that promotes the multiple health benefits of both exercise and     high-calcium milk to young children.   "
238640|NCT00979524|"     This project's focus is twofold—to change the culture of an employment training program for     adolescents and young adults (Youth Opportunities, or YO) to more fully address the many     mental health issues faced by its participants and to expand and improve the quantity and     quality of mental health services for YO members. Four project components have been carefully     selected to address the mental health issues of YO members: (1) Mental health     education/training for YO staff and peer leaders, (2) Mental health education activities for     YO members, (3) mental health screening on all newly enrolling YO members, and (4)     comprehensive mental health services for YO members. These project components will be     implemented at the HEBCAC YO Program (subsequently referred to as Eastside YO), with the     Westside YO Program initially participating as a control site. Researchers at the Johns     Hopkins University Center for Adolescent Health, led by Dr. Darius Tandon of the Department     of Pediatrics, will conduct the research examining the effectiveness of these mental health     services and supports.      There are four project objectives. First, the proposed activities will increase YO members'     knowledge of mental health resources and decrease stigma associated with seeking mental     health services. Second, the investigators will see an increase in YO members' receipt of     needed mental health services. Third, the investigators will see improvement in YO members'     mental health. Fourth, as a result of their improved mental health, YO members will more     actively engage in YO program activities and achieve more key program milestones (e.g., GED     completion). These objectives are sequential, with later objectives predicated on the     achievement of earlier ones.   "
238641|NCT00979537|"     The objective of this study was to investigate the bioequivalence of nisoldipine     extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release     40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg     tablet) dose administration in healthy adult subjects under fed conditions.   "
238642|NCT00979550|"     The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser     treatment of vascular malformations.   "
238643|NCT00979563|"     The main objective of this study is to determine the maximum tolerated dose (MTD) of     OratecanTM. Eligible subjects of this study are patients with histologically or cytologically     confirmed malignant solid tumor refractory to standard therapy or for which no established     therapy exists at the time of study participation.   "
238644|NCT00979576|"     The objectives of this trial are to estimate the following in Japanese patients with advanced     NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy.      Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD)     of BIBF 1120 at a dose level up to twice daily 200 mg with standard dose of pemetrexed (500     mg/m^2) and to determine the Recommended Dose (RD) for the phase II part.      Phase II, to investigate the efficacy and safety of BIBF 1120 in combination with pemetrexed     (500 mg/m^2) as compared to pemetrexed (500 mg/m^2) + placebo   "
238645|NCT00979589|"     The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel     initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days     versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke     (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom     onset in high-risk patients with TIA or minor stroke.   "
238646|NCT00979602|"     The purpose of this study is to characterize the safety, immunogenicity, and relative     efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of     age or older.   "
238648|NCT00979628|"     High blood glucose levels in medical and surgery patients with diabetes are associated with     increased risk of in-hospital complications and death. Improved glucose control with insulin     injections may improve clinical outcome and prevent some of the hospital complications.     Numerous studies have shown that high blood glucose increases the risk of wound infection,     kidney failure and death. It is not known; however, what is the best insulin regimen in     patients who will undergo surgery. The use of repeated injections of regular insulin is     commonly used for glucose control in hospitalized patients with diabetes. Recently, the     combination of Lantus® and Apidra® insulins has been shown to improve glucose control with     lower rate of hypoglycemia (low blood sugar). The investigators' recent preliminary data also     indicate that a single daily dose of glargine plus corrective doses of glulisine before meals     if needed (Basal Plus) is effective in the management of medical and surgical patients with     type 2 diabetes mellitus (T2DM). The average daily blood glucose (BG) levels in patients     treated with Basal Plus is equivalent to levels in patients treated with Basal Bolus with     glargine once daily plus glulisine before meals (basal bolus regimen). The mean daily BG     levels in patients treated with basal plus are lower than those reported in patients treated     with sliding scale regular insulin (SSRI). Accordingly, the present study aims to determine     which insulin treatment is best for glucose control in hospitalized patients with diabetes     admitted to general medicine wards. Glargine, glulisine, and regular insulins are approved     for use in the treatment of patients with diabetes by the FDA.   "
238649|NCT00979641|"     The purpose of this study is to evaluate the efficacy and safety of the combination of     biweekly docetaxel and bevacizumab in the first line treatment of metastatic breast cancer by     using Response Evaluation Criteria In Solid Tumors (RECIST criteria) and NCI Common     Terminology Criteria for Adverse Events (NCI CTC-AE) version 3. In addition several     biochemical makers are tested as possible predictive factors.   "
238650|NCT00979654|"     The objective of this study is to assess the safety and tolerability of sifalimumab in adult     participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or     polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or     MI-CP179.   "
238651|NCT00979667|"     To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with     its control arm with respect to symptoms duration among patients infected with influenza A     (H1N1) virus.   "
238652|NCT00979680|"     This phase III trial included patients with low rectal adenocarcinoma which initially     required APR, with a mean clinical distance between the tumor inferior pole and the levator     ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or     radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the     tumor status at surgery. All surgeons used a homogenous SSR technique such as     intersphincteric resection. The primary endpoint was the SSR rate.   "
238653|NCT00979693|"     This study is to find out about whether two sessions of psilocybin-assisted psychotherapy are     safe and will help people who are anxious as a result of having stage IV melanoma and will     involve two sessions of psychotherapy combined with either 4 or 25 mg psilocybin. The study     will measure anxiety, depression, quality of life and spirituality before and after     psilocybin-assisted psychotherapy, natural killer cells (a type of immune cell) will be     counted from blood samples taken the day after psilocybin-assisted psychotherapy, and people     will keep daily diaries reporting on how anxious they feel for each day in the study.   "
238654|NCT00979706|"     Pilot study for the treatment of primary HIV infection with the objective to induce a strong     specific HIV immune response able to control viral replication without HAART.   "
238655|NCT00979719|"     To help rehabilitation patients to adopt and maintain a physically active lifestyle, it is     imperative to increase self-management competencies. Aim of this research project is to     evaluate an evidence- and theory-based computerized expert system in comparison to a well     established standard program and a questionnaire-only group. Rehabilitation patients will be     treated psychologically and followed up over 18 months. The computerized expert system is     expected to help patients better than the standard program. Both interventions are     hypothesized to improve self-management competencies over and above the rehabilitation     treatment (i.e., questionnaire-only group).   "
238656|NCT00979732|"     In this research study, the investigators are interested in learning how extracts from grape     seeds can help those individuals with high blood pressure. The investigators also hope to     learn how grape seed extract effects your blood and cell functions.      The grape seed extract the investigators will use in the study will be provided either in a     beverage or a capsule form and is currently available on the market. This study is also using     a placebo; therefore the treatment subjects receive may or may not contain the grape seed     extract.      The purpose of this study is to determine if the grape seed extract (GSE) will lower blood     pressure in people with slightly high blood pressure (Pre-Hypertension).   "
238657|NCT00979745|"     Afamelanotide is a man-made drug being studied for use as a preventative medication for EPP     sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating     hormone (alpha-MSH) and is not yet available on the market.      The purpose of this study is to look at whether afamelanotide can reduce the number and     severity of EPP symptoms when patients are exposed to light. This study will also look at how     the drug is tolerated when taken by people with EPP.      The study will involve the use of an implant, which comes in the form of a small rod     (approximately 2 cm x 0.15 cm) to be administered under the skin. The implant may contain the     study drug afamelanotide or a placebo (inactive medication).      Over 450 subjects have been treated with afamelanotide to date with no serious safety     concerns identified. For this study, afamelanotide has been formulated as a controlled     release depot injection (implant). This means that the afamelanotide will be released slowly     into the body over a few days. Once inserted, the implant will remain in the body after     afamelanotide has been released and will slowly dissolve.      This study will help to provide more information about afamelanotide. This information will     be used to determine the safety and efficacy (the ability of the drug to produce an effect)     of this drug in EPP sufferers.      Up to 70 people will participate in this study from study sites across Europe.   "
238671|NCT00979927|"     The purpose of this study is to investigate the safety and tolerability of SPC3649 given in     multiple doses to healthy volunteers.   "
238658|NCT00979758|"     The benefit of current stem cell transplantation therapy for myocardial infarction is limited     by low survival rate for stem cell. The purpose of this study is to test whether intensive     Atorvastatin therapy can improve the outcome of patients with impaired left ventricle     function after myocardial infarction who underwent intracoronary transfer of autologous bone     marrow cells.   "
238659|NCT00979771|"     The purpose of this study is to determine if GSK706769 can maintain clinical remission     established by Enbrel after withdrawal of Enbrel in rheumatoid arthritis patients.   "
238660|NCT00979784|"     The hypothesis of this study is that overweight and obese patients exposed to sleep focused     counseling and standard dietary and exercise counseling will have better outcomes than     similar patients exposed to standard dietary and exercise counseling only.   "
238661|NCT00979797|"     The proposed four-year randomized study will attempt to test the hypothesis that     community-based child health interventions in conjunction with facility-based IMCI will     improve child care practices, nutritional status and child survival. The objectives of this     research are:        1. To measure the effectiveness of the community-based interventions in improving selected          child care practices in the community.        2. To measure the effectiveness of the community-based interventions in improving child          nutritional status and in reducing child morbidity and mortality.        3. To document the process of implementation of community-based interventions at scale to          promote selected key family and community practices related to child health.        4. To undertake cost-effectiveness analysis of the interventions.      Integrated Management of Childhood Illness (IMCI) is a strategy developed by the World Health     Organization (WHO) and UNICEF to reduce childhood mortality and morbidity and to contribute     to improved growth and development of children under-5 years of age Experience suggests that     a purely facility based strategy will not reach the significant portion of the population     that does not have access to or choose not to use a health facility. Links between the     service providers and families at household levels is essential in order to ensure that     families have the knowledge, skills and ability to provide appropriate preventative and     curative care to their children. However, globally, actual evidence of effectiveness of     community-based IMCI interventions implemented at scale is meager.      C-IMCI in Bangladesh will be implemented by GoB in partnership with NGOs and also through     active participation of different community groups, civil societies, and the private sector.      Both GoB and UNICEF/Bangladesh have agreed that an evaluation of the C-IMCI implementation by     GoB, as proposed here, would be very opportune and useful in providing the evidence and     analysis of lessons that will guide further scale-up in the country.      A cluster-randomized design will be used for this evaluation. Fourteen Upazilas where     facility-based IMCI is already in place will be selected, and 7 upazillas will be randomly     allocated to C-IMCI intervention and 7 to comparison. Community-based IMCI in the     intervention upazillas will be implemented by GoB through the district health system while in     the comparison upazillas existing services will continue, including facility-based IMCI.   "
238662|NCT00979810|"     The purpose of this study is to evaluate high and low areas of growth, or proliferation,     within the tumor. An imaging technique using a very small amount of a radioactive tracer     called 18Ffluoro-deoxy-L-thymidine (18F-FLT) can detect areas of rapid growth within the     tumor. This imaging technique is called a FLT PET imaging. This present study involves     obtaining one scan using FLT PET imaging. The goal of this study is to investigate     associations between the imaging findings showing differences in growth rate within the tumor     and the biology of the tumor that is measured in the sampled tumor tissue. This information     may be used in future brain tumor patients to determine the best combination of treatment for     individual patients. These studies may also improve our understanding of the types of changes     taking place in brain tumor tissue that could improve individual patient outcome. FLT is     produced for human use by the MSKCC cyclotron facility under an investigational new drug     (IND) approval issued by the US Food and Drug Administration (FDA). This means that FLT is     produced under strict rules and regulations, is considered safe, and has been approved for     use in humans for certain disease conditions. 18F-FLT has been used in several research     studies to date at this institution.   "
238663|NCT00979823|"     The objective of this translational research is to study the effect of implementing an     innovative simulated diabetes learning intervention within primary care residency programs.     The intervention uses cognitive behavioral learning theory to provide goal-directed feedback     to residents after every encounter over a series of virtual patient-physician encounters.     Formulas derived from pharmacokinetic data and the experience of clinical experts model     simulated physiologic responses to drug changes, health behaviors, and adherence factors. The     online intervention is economical, sustainable, and addresses a number of current obstacles     to outpatient diabetes training in primary care residency programs.      In this group trial, we randomly assign about 20 primary care residency programs with up to     700 residents total to either an (a) Early learning program group or (b) Delayed learning     program group. We will assess the ability of residents to achieve evidence-based diabetes     clinical goals and avoid potential medical safety issues for glycemia, blood pressure, and     lipids on simulated assessment cases. Secondary analyses will evaluate the actual use of the     tool by residents, direct costs of the program, and resident satisfaction.   "
238664|NCT00979836|"     The objective of the study is to assess the efficacy of calcium dobesilate for treating     chronic venous wounds.      The hypothesis is that venous ulcers treated with standards measures (compressive measures)     and calcium dobesilate will heal-up better than venous ulcers treated with standards measures     (compressive measures) and placebo.   "
238665|NCT00979849|"     The aim of the study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of AZD8683 following single ascending dose administrations in healthy male     subjects.   "
238666|NCT00979862|"     This phase I trial is studying the side effects and best dose of cediranib maleate when given     together with cilengitide in treating patients with progressive or recurrent glioblastoma.     Cediranib maleate and cilengitide may stop the growth of tumor cells by blocking blood flow     to the tumor. Giving cediranib maleate together with cilengitide may kill more tumor cells.   "
238667|NCT00979875|"     This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to     determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of     subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20     (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone,     insulin aspart + rHuPH20, and insulin aspart alone.   "
238668|NCT00979888|"     RATIONALE: Gathering information about how patients, caregivers, and healthcare professionals     cope with symptoms caused by lung cancer, such as breathlessness, cough, fatigue, anxiety,     depression, pain, and difficulty sleeping, may help doctors learn more about non-drug methods     of treating symptoms of respiratory distress.      PURPOSE: This clinical trial is studying how caregivers help patients cope with respiratory     and other symptoms caused by lung cancer.   "
238669|NCT00979901|"     This study will evaluate the ability of montelukast to improve the signs and symptoms of     seasonal allergic rhinitis compared with loratadine and placebo.   "
238670|NCT00979914|"     Osteoarthritis is a common disease. The core treatment is often patient education. The aim of     this study is therefore to study the effect of a patient education programme for patients     with osteoarthritis in primary health care.   "
238674|NCT00979966|"     This will be a prospective, open-label, randomized multicenter phase-II study to evaluate     progression free survival (PFS) in patients with locally advanced or metastatic non-clear     cell renal cell cancer (ncc-RCC) receiving Temsirolimus in comparison to Sunitinib.      In most clinical trials in renal cell carcinoma (RCC), clear cell RCC have been included     exclusively. There are only some limited data on the efficacy of Temsirolimus or Sunitinib in     ncc-RCC showing interesting response rates for both agents. However, randomized clinical     trials in this specific patient population have not yet been performed.      In the proposed study a comparison Temsirolimus and Sunitinib is scheduled in first line     therapy of ncc-RCC.   "
238675|NCT00979979|"     Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma     (HCC) and liver transplantation, affects approximately 170 million individuals worldwide.     Combination of peginterferon plus ribavirin therapy has become the current standard of care     for chronic hepatitis C (CHC) patients, with an overall sustained virologic response (SVR)     rate of 54-63% and more favorable response rates in patients with genotype 2/3 infection than     those with genotype 1/4 infection. Therefore, accurate pre-treatment HCV genotype evaluation     is of paramount importance to facilitate individualized therapy in the era of response guide     therapy and specific-targeted antiviral therapy for HCV (STAT-C).      Currently, direct HCV genetic sequencing for both the 5' untranslated terminal region (5'UTR)     and non-structural 5B (NS5B) regions with subsequent phylogenetic tree analysis is considered     the gold standard for determining HCV genotype and subtype. However, it is time-consuming and     need special laboratory settings. Several commercial available reverse hybridization with     type-specific probing assay (Inno-LiPA II) or simplified direct sequencing of the 5'UTR     region were used to replace the two region sequencing method (Trugene HCV 5' NC genotyping     kit). Nonetheless, data on the overall diagnostic accuracy varied.      The Abbott RealTime HCV Genotype II is an in vitro reverse transcription-polymerase chain     reaction (RT-PCR) assay for determining the genotype(s) of HCV in plasma and serum from     HCV-infected individuals. Based on genetic similarity, HCV has been classified into six major     genotypes (1-6) and numerous subtypes. HCV genotype is predictive of the response of     HCV-infected patients to peginterferon plus ribavirin combination therapy. The Abbott     RealTime HCV Genotype II assay uses the Abbott m2000sp instrument for processing samples and     the Abbott m2000rt instrument for amplification and detection. Furthermore, the Abbott     m2000sp provides automated sample transfer and reaction assembly of the assay reagents in the     Abbott 96-Well Optical Reaction Plate.      The investigators aimed to evaluate the overall diagnostic accuracy of the currently     available commercial HCV genotype kits (Abbott RealTime HCV Genotype II) by using 5'UTR and     NS5A gene amplification and direct sequencing as the gold standard.   "
238676|NCT00979992|"     This phase II trial studies the side effects of sunitinib malate and how well it works in     treating patients with ovarian cancer that is persistent or has come back. Sunitinib malate     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and     by blocking blood flow to the tumor.   "
238677|NCT00980005|"     The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'     investigational vaccine GSK1557482A.   "
238678|NCT00980018|"     The purpose of this exploratory study will be to examine changes in chronic low grade chronic     adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading,     when patients are switched from imatinib to nilotinib therapy.   "
238679|NCT00980031|"     The goal of this project is to investigate the effects that the addition of aldosterone     blockade with eplerenone will have on the progression of diastolic dysfunction in patients     with controlled essential hypertension.   "
238680|NCT00980044|"     Prescription opioid addiction is a growing public health problem and more pharmacologic     treatments are needed because current approved medications have had limited patient     acceptance (naltrexone), limited availability (methadone), and concerns about misuse and     diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to     treat moderate-severe pain, and initial studies demonstrate that it may be useful for     treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric     effects. This study will determine whether two different doses of extended release tramadol     can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no     longer taken.   "
238681|NCT00980057|"     The purpose of this study is to show that Adaptive CRT is at least as good at optimizing a     patient's cardiac resynchronization therapy (CRT) as the current method of using an     echocardiogram. Adaptive CRT (aCRT) is an implantable heart failure device feature that     attempts to optimize CRT without echocardiographic testing.   "
238682|NCT00980070|"     This is a pilot study to evaluate a restraint device for lumbar punctures. Designed to help     improve the restraint techniques for lumbar puncture, the restraint device will be compared     to the current standard of manual physical restraint in neonatal and pediatric patients (age     1 day to 90 days of life). The investigators will study 30 subjects, with 20 randomized for     the experimental device and 10 randomized for the control group, which is current standard     of care. The investigators' primary outcomes will include time of procedure, red blood cells     in the cerebrospinal fluid as well as physician satisfaction. Subjects will be eligible if     they are 1-90 days of life, and their treating physician believes lumbar puncture is     indicated. There is no follow-up once the lumbar puncture has been completed and the data has     been obtained.   "
238683|NCT00980083|"     Synthetic GLP-1 lowers postprandial (pp) glycemia by stimulating insulin, inhibiting     glucagon, and delaying gastric emptying. However, the effects of the endogenous peptide are     largely unknown. Using the specific GLP-1 receptor antagonist exendin(9-39)amide (Ex(9-39))     the investigators recently showed that GLP-1 released during intestinal meal perfusion acts     as an incretin hormone and as an enterogastrone. As the relative contributions of these     effects to controll postprandial glycemia are unclear, the investigators used Ex(9-39) to     investigate the mechanisms of action of GLP-1 after an oral meal in humans.   "
238684|NCT00980109|"     This is a multicenter, randomised, four arms placebo controlled study to evaluate the safety     and tolerability of 10 mg inhaled zanamivir once a day and 75 mg oseltamivir capsule orally     once a day relative to placebo over 16 weeks (112 days). Enrolled subjects will be randomly     assigned to 2:1:2:1 ratio (active oseltamivir: placebo: active zanamivir: placebo) on one of     the four study treatment groups.      It is hypothesized that oseltamivir and zanamivir will protect participants from becoming     infected with influenza.   "
238685|NCT00980122|"     Cancer is the commonest cause of death in Singapore, and many cancer deaths occur in     hospital.      Management of cancer patients is getting more complex with constant development of new drugs,     interventional procedures and supportive measures. Despite this, the majority of advanced     cancer patients will die from their disease or related complications.      There is a lack of data on the utilisation of health resources in advanced cancer patients in     this country. In this study the investigators ask themselves how aggressive care was in the     last 3 months of the patient's life. The investigators will be collecting data on specific     cancer treatments, interventional procedures, and supportive measures.   "
238687|NCT00980148|"     Chlamydia is a common infection among youth and can be given from one person to another     during sex. Many people who have chlamydia have no signs of infection at all, but can pass     the infection to anyone they have sex with. If not treated, chlamydia can lead to serious     health problems. This study will look at how well medicines given for chlamydia infection     work. The study requires 306 evaluable subjects, chlamydia-positive, males and non-pregnant     females, ages 12-21, living in long-term, gender-segregated youth correctional facilities.     Participants will be assigned to receive either doxycycline (2 times per day, by mouth, for 7     days) or azithromycin (1 single dose by mouth). Study procedures will include collection of     at least 3 urine samples to test for chlamydia. Study visits will occur during initial     enrollment in the study, day 28 after starting treatment, and day 67. Participants will be     involved in study related procedures for up to 67 days.   "
238688|NCT00980161|"     Combination therapy with peginterferon plus ribavirin has become the current standard of care     for chronic hepatitis C (CHC) patients, with an overall sustained virologic response (SVR)     rate of 54-63%. Based on the ample evidence, a 48-week course of peginterferon plus     weight-based ribavirin therapy is widely recommended to treat HCV genotype 1 infection in     different parts of the world. Despite the increased SVR rates with the improved medical     therapies, about 25-50% and 10-20% of HCV genotype 1 and HCV genotype 2/3 patients may     experience relapse after the cessation of therapy with undetectable HCV viremia at the end of     treatment. Moreover, combination therapy is costly and may cause various adverse events.     Therefore, individualized therapy based on outcome analysis should be adopted to save medical     cost as well as to lessen inadequate treatment. Few studies are aimed to evaluate the host     responses of micro RNA regulation during interferon-based therapy and its relationships to     the overall treatment responses.      Micro RNA (miRNA) is a single-stand RNA composed of 21-23 nucleotides, which may regulate the     function of messenger RNA (mRNA). The regulating mechanisms involving micro RNA between the     hosts and the HCV virus include (1) auto-regulation of HCV mRNA by HCV miRNA; (2) regulation     of host mRNA by HCV miRNA; and (3) regulation of HCV mRNA by host miRNA. MiR-122 is the     abundant liver-specific miRNA which is crucial for efficient HCV replication in culture Huh7     cells stably expressing HCV replicons. Recently, an in vivo study for hepatic miR-122 of 42     patients with CHC who received IFN-based therapy showed that patients who did not respond to     IFN therapy had markedly decreased pretreatment miR-122 levels. Although miR-122 is abundant     in the liver, liver biopsy is still considered an invasive procedure, which prevents its     widespread use in routine clinical practice. The miRNA can be detected in the sera and is     stable after 24 hours of room temperature store or repeated freezing and de-freezing. The     serum miR-122 levels can reflect the severity of liver injuries in a rat acetaminophen     toxicity model. Because miR-122 is liver specific and the miRNA is stable in the sera, the     investigators aimed to evaluate the role of serum and hepatic miR-122 on the viral kinetics     and the treatment responses and in HCV patients receiving peginterferon and ribavirin     combination therapy.   "
238689|NCT00980174|"     The purpose of this study is to assess how effective and safe denosumab is in a population of     males with low bone mass at risk of fracture. The primary clinical hypothesis is that in men     with low bone mineral density, the mean percent change in lumbar spine bone mineral density     at 12 months in subjects receiving denosumab will be greater than in subjects receiving     placebo. Denosumab is a fully human monoclonal antibody with a high affinity for Receptor     Activator of Nuclear Factor (RANK) Ligand that can bind and neutralize the activity of human     RANK Ligand similar to the action of endogenous osteoprotegerin.   "
238690|NCT00980187|"     The aim of this study is to evaluate the effects of indapamide SR 1.5 mg on blood pressure,     blood tests (glucose metabolism, lipids, minerals, and uric acid), cardiac function,     endothelial and arterial function, by comparison with hydrochlorothiazide 25 mg, in patients     with hypertension and type 2 diabetes mellitus. In order to achieve a better control of blood     pressure in these patients, each diuretic treatments will be added to an ACE inhibitor     (quinapril 10-40 mg/day). Therefore, eventually, the study will provide data on the     comparison between combination indapamide SR 1.5 mg + quinapril versus hydrochlorothiazide 25     mg + quinapril.   "
238691|NCT00980200|"     The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate     the efficacy and safety of selected doses and dose intervals of the novel long acting beta     agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving     inhaled corticosteroid treatment.   "
238692|NCT00980213|"     Patient receiving sunitinib according the clinician's independent decision as first-line     treatment of advanced renal cell carcinoma (RCC) will be asked for informed consent.     Treatment with sunitinib will start and end solely on the treating clinicians and the     patients independent discretion. Consenting patients will prospectively answer standardized     quality of life questionnaires (15D, EQ-5D) during the treatment. Data on health care     resource utilisation will be collected prospectively (outpatient visits, hospital stays,     concomitant drugs, investigations, sick-leaves, travels). In addition, after treatment     failure anti-cancer drugs, hospital stays and date of death will be recorded.      The health economic data during sunitinib treatment and the length of the sunitinib treatment     will be compared with the corresponding previously published data collected retrospectively     from patients with the same condition treated with IFN-alfa. Stepwise regression analysis     will be used to explore whether patient and tumor characteristics explain potential variation     in treatment duration and costs that is not explained by the treatment.      Health-related quality of life (HRQoL) data will be presented as descriptive data and     compared to age-standardized general population.      At least four major Finnish oncology centers have consented to participate in this study. The     inclusion time will be approximately 24 months, and the study time approximately 48 months.     Eighty patients will be included.   "
238693|NCT00980239|"     The goal of this clinical research study is to learn the highest tolerable dose of irinotecan     that can be given directly into the liver, in combination with other drugs given by vein.      The other drug combinations given by vein include bevacizumab alone, bevacizumab plus     oxaliplatin, and bevacizumab plus cetuximab.      This will be tested in patients with advanced solid tumors that have spread to the liver. The     safety of these drug combinations will also be studied.   "
238694|NCT00980252|"     This is a randomized pilot study of an intervention based on principles of Cognitive     Behavioral Therapy (CBT). This intervention is the Health Dialogue Intervention (HDI) and     will be compared to a traditional medical model of psychoeducation known as Team Solutions     (TS) for first-episode schizophrenia patients. Outcomes include the acceptance of HDI and TS,     compare adherence attitudes at the end of the treatment intervention, and to compare the time     until the first episode of nonadherence.   "
238780|NCT00981526|"     This is a 12-week, randomized, double-blinded, placebo-controlled trial of telmisartan 80     mg/day as an adjunctive to clozapine or olanzapine therapy, in 70 schizophrenia subjects to     examine telmisartan's effect on glucose metabolism, weight, food intake, resting energy     expenditure, and body composition. In addition, the study will examine insulin's effects on     psychopathology and cognition.      Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or     Massachusetts General Hospital. Approximately 70 subjects will be enrolled.   "
238695|NCT00980278|"     The purpose of this research is to determine if one's own bone marrow tissue can help     regenerate (grow) bone in the area of the jaw where an implant will be placed. The name of     the process is called Bone Repair Cell (BRC) Therapy. A sample of bone marrow tissue will be     collected and sent to a laboratory where it will be processed to form more cells. These new     cells will then be transplanted in the regenerative site or sinus floor augmentation site.     The researchers are testing to see if these cells (BRC) will help form bone indicating. The     research will also determine if the implant will be more stable in the area with new bone     growth.   "
238696|NCT00980304|"     It is a phase II , multicenter, open label clinical trial. Only the relapsed DLBCL patients     after 1st line induction treatment of 6~8 cycles of RCHOP-like chemo will be enrolled to     receive 3 cycles of RICE as salvage therapy.      After treatment each patient should be followed up for 2 years.   "
238697|NCT00980317|"     Approximately 30,000 new patients are introduced into dialysis and about 20,000 of them die     every year in Japan. At present, about 300,000 patients are on dialysis and more than 10,000     patients are registered to the Japan Organ Transplant Network (JOTN) with the hope for a     renal transplantation. If the renal function is restored by transplantation, the quality of     life (QOL) improves and more than 90% are reportedly come back to their normal life     activities and get relieved from the burden of dialysis. Furthermore, it can reduce the     dialysis related medical cost by as much as 50%. However, only about 1,000 renal     transplantation cases are annually carried out in Japan. Among them, 80-85% are living renal     transplantations offered by family members or relatives, and the rest are from deceased     donors.      Due to the fact that the number of deceased donors are scarce and renal transplantations     between non-relatives (third parties) are currently not allowed in Japan, the approximate     waiting time to receive a renal transplantation is 16 years. For that reason, many patients     travel abroad to receive a renal transplantation.      There are reports that total nephrectomies are performed as a treatment for small size (4 cm     or less) renal tumors in many cases and that many of these nephrectomized kidneys can be     successfully transplanted after surgical restoration with satisfactory results. However, due     to the lack of necessary evidence it is currently not allowed in Japan.      Therefore, the investigators planned the present clinical study to evaluate the curative     efficacy (renal function, QOL) and safety (side effects, complications or occurence of renal     cancer) of living renal transplantations between third parties (non-relatives) with restored     donor kidneys after the surgical removal of a small size (4 cm or less) renal tumor, in order     to acquire necessary clinical data for potential enrichment of the renal donor pool in Japan     as well as to develop useful medical care for our patients who are on dialysis for many years     due to the renal failure.   "
238698|NCT00980330|"     The purpose of this study is to determine the efficacy, safety and tolerability of different     regimens of TMC435 with standard treatment compared to standard treatment alone in     participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed     previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).   "
238699|NCT00980343|"     This randomized phase II trial is studying how well GDC-0449 works in treating patients with     recurrent glioblastoma multiforme that can be removed by surgery. GDC-0449 may be effective     in treating patients with glioblastoma multiforme.   "
238700|NCT00980356|"     The purpose of this study is to determine whether monotherapy with Vildagliptin improve     glycemic control in kidney transplanted patients with newly diagnosed New Onset Diabetes     after Transplantation (NODAT).   "
238701|NCT00980369|"     The purpose of this study is to determine effective incision type for the treatment of     chronic anal fissures.   "
238702|NCT00980382|"     This study is an open-label, single center, nonrandomized study, consisting of a     dose-escalating phase I study in advanced solid cancer and a subsequent phase II study in     metastatic gastric cancer. In phase I study, we aim to determine the MTD and the recommended     dose of S-1 combined with docetaxel given every 3 weeks. Dose level and escalating schedule     are followings        -  S-1(level 0, 1/2, 3/4, 5: 60, 70, 80, 90 mg/m2/day) q 12 hours po Days 1-14)        -  Docetaxel (level 0/1,2/3, 4/5: 25, 30, 35 mg/m2) mixed in d5w 200 ml iv over 60 min:          Days 1, 8with dexamethasone 8 mg po q 12hr for 3 days (total 6 doses: D0-2)and          parenteral pheniramine maleate 1 ample (45.5mg) before docetaxel   "
238703|NCT00980395|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cladribine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Giving bortezomib together with     cladribine and rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib together with cladribine     and rituximab works in treating patients with advanced mantle cell lymphoma or indolent     lymphoma.   "
238704|NCT00980408|"     The hippocampus is particularly laden with n-methyl-d-aspartate (NMDA) receptors, and is at     the same time one of the most important sites in declarative memory. The rationale of this     study is that the NMDA partial agonist D-Cycloserine will promote learning compared to a     placebo. On the other hand, the NMDA receptor antagonist Memantine might lead to reduced     memory. We believe that the influence of NMDA receptors on memory can be determined via acute     co-activation of the NMDA receptors with Cycloserine® (King Pharmaceuticals Ltd, active     ingredient: DCycloserin, dose: 250 mg) and Memantine (Axura®, Merz, active ingredient:     Memantine, dose: 20 mg)on both a behavioral and functional (fMRI) level.   "
238705|NCT00980421|"     The purpose of study is to evaluate and compare the effect of iron supplementation when given     as iron tablet or fortified biscuit or combined with zinc in the form of tablet on morbidity     and iron toxicity markers among children aged 24-36 months.   "
238706|NCT00980434|"     The investigators are studying the clinical worth of the serum markers S-100B and NSE in     patients with spinal cord injuries e.g. in patients with vertebral fractures. If there is a     injury to the neuronal structures these two proteins could be secreted into the serum and add     evidence to the severity of the injury.   "
238707|NCT00980447|"     UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004).      The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among     three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per     patient with a 3 week interval between vaccination in healthy young adults.      Immunogenicity will be confirmed by both microneutralization (MN) antibody and     hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving     different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a     total of 90 healthy young adults aged 20-40 years enrolled in this study.   "
239319|NCT00987337|"     The primary objective for this study is to determine if the addition of filibuvir to a     standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the     proportion of subjects who achieve a sustained viral response (SVR) compared to     peginterferon/ribavirin (pegIFN/RBV) therapy alone.   "
238709|NCT00980473|"     Glaucoma is the leading cause of irreversible blindness worldwide. With ageing of the     population, glaucoma morbidity will rise, causing increased health care costs and economic     burden for a condition in which visual loss, once established, cannot be reversed. In     contrast to western countries, primary angle closure glaucoma (PACG) is a major form of     glaucoma in Asia. In a recent population based survey in Singapore, the prevalence of     glaucoma was 3.2% in the Chinese population over 40. Glaucoma was the leading cause of     blindness, with PACG the most visually destructive form of the disease.      Laser iridotomy is the current first line treatment for PACG. It acts by relieving pupil     block, which in turn may reduce intraocular pressure (IOP) and prevent progression of     glaucoma. However recent data indicate that iridotomy is not successful in controlling IOP in     the long term, and the majority of cases develop a clinically significant rise in IOP     requiring medical therapy or surgery.      Argon laser peripheral iridoplasty (ALPI) offers a new therapeutic option for PACG. The     procedure consists of placing contraction burns in the iris periphery which results in     contraction of the iris stroma and opening of the angle.      The proposed study is a 2-centre randomized controlled trial to determine whether ALPI is an     effective and safe treatment in the management of PACG. 210 patients with PACG and high IOP     (>21 mmHg) following laser iridotomy will be randomized to receive ALPI or medical treatment     to achieve IOP control. Subjects will be followed up for 12 months and the outcome criteria     will be the rate of medical treatment and surgery in each group, and the angle width and     configuration.      This will be the first RCT worldwide to address the role of ALPI in PACG. The study findings     will have great relevance for the prevention of glaucoma blindness in the elderly.   "
238710|NCT00980486|"     The purpose of this study is to determine whether the dose of prophylactic antibiotics at the     time of cesarean delivery requires adjustment in obese and overweight patients in order to     achieve optimal antimicrobial activity.   "
238711|NCT00980512|"     The primary goal of this study is to examine the fidelity and generalization of parenting     effects of the KEEP foster parent training intervention as it is being delivered within a     child welfare system of care by a community mental health provider.   "
238712|NCT00980525|"     The purpose of this study is to determine if certain levels of proteins lead to inflammation     of the gums. One example of such proteins being studied is called Interleukin 1 (IL-1). This     protein is found at higher levels in areas of inflammation. This type of study is called an     experimental gingivitis study. It will involve stopping your routine oral health care for 21     days. If you qualify, you will receive a full dental cleaning at the beginning and end of the     study. Approximately 30 patients will participate in this study at the Michigan Center for     Oral Health Research (MCOHR).   "
238713|NCT00980538|"     The primary objective is to continue the provision of etravirine (ETR) for patients who     previously received ETR in a clinical pediatric trial sponsored by or in collaboration with     Janssen Research & Development, and who continue to benefit from the use of ETR, in countries     where ETR is not commercially available for pediatric use, is not reimbursed, and cannot be     accessed through another source (e.g. access program or government program), or where the     patient is not eligible for ongoing trials/programs with ETR.   "
238714|NCT00980551|"     The investigators are testing subtenon carboplatin in combination with vincristine and     topotecan given by vein in the hopes of finding a drug combination that may be effective     against retinoblastoma that has come back (recurrent) or is resistant to other treatment     (refractory).      The goals of this study are:        -  To decide if the drug combination is a useful treatment for recurrent or refractory          retinoblastoma        -  To test the safety of the drug combination and to see what kind of effects (good and          bad) can be expected from the drug combination        -  To measure visual changes before and after the study therapy        -  To use a special MRI scan to measure brain function involved in vision processing, both          before and after the study therapy      In this study, the investigators are also testing a new experimental way of giving     carboplatin subtenon carboplatin. The carboplatin will be given directly in the eye through     a needle placed under the covering of the eye. This is to try to get more carboplatin to the     retinoblastoma inside the eye.   "
238715|NCT00980577|"     To study whether the combination of ultrasound guidance and stimulating catheter could reduce     the time for needle and catheter insertion compared with using stimulating catheter alone.     Secondary outcomes: analgesic effects after the surgery.   "
238716|NCT00980590|"     Pre-hospital intubation is often required in sub-optimal conditions, such as in patients     lying on the ground. Direct laryngoscopy and intubation of a patient lying supine on the     ground is difficult because the intubator's head is far above the head of the patient. It is     thus tricky to align the intubator's visual axis with the patient's tracheal axis. The Airway     Scope is a new laryngoscope designed to facilitate intubation without requiring alignment of     the oral, pharyngeal, and tracheal axes. We thus tested the hypothesis that the intubation     with the Airway Scope is faster than the Macintosh laryngoscope in subjects lying on the     ground.   "
238717|NCT00980603|"     The purpose of this study is to assess efficacy and safety of docetaxel alone, docetaxel plus     cisplatin, and docetaxel plus S-1 in patients with metastatic gastric cancer after failing     1st line chemotherapy with cisplatin plus S-1 or capecitabine   "
238718|NCT00980616|"     The aim is to determine if the use of infiltration with an adrenalin solution in the     operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the     cumulated volume of bleeding (pre and post operative) without increasing the per and post     operative risks. At the same time, the effect on the post operational pains is evaluated.   "
238719|NCT00980629|"     This study is to investigate the efficacy and safety of M516102 and to evaluate the dose     response relationship of M516102 and placebo, in the treatment of pruritus associated with     atopic dermatitis.   "
238720|NCT00980642|"     Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at     the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal     temperature and oral temperature for routine clinical use during hypothermic conditions, as     well as during fever.   "
238721|NCT00980655|"     People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more     likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people     who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal     polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study     is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal     vaccine (13vPnC) followed by 23vPS.   "
238722|NCT00980681|"     The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA     in patients suffering from renal arterial disease.   "
239320|NCT00987350|"     This research study involves testing of a device that can give injections (shots) without the     use of a needle.   "
238723|NCT00980694|"     The death of brain cells in Huntington Disease (HD) is thought to be associated with a lack     of normal cell energy and harmful brain substances called free radicals. Coenzyme Q10 (CoQ)     is a marketed nutritional supplement that may prove useful in HD because it increases cell     energy and combats free radicals.      Most studies of CoQ have looked at only one formulation of CoQ (ubiquinone) in HD. The     purpose of the study is to find out if people that switch from the common formulation of CoQ     (ubiquinone) to a different formulation (ubiquinol) have higher levels of CoQ in their     blood after taking the same dose. The investigators also want to find out if this different     formulation is tolerable for individuals with HD.   "
238724|NCT00980707|"     The purpose of this study is to determine the role of versican and hyaluronan measurements in     induced sputum as biomarkers of asthma. Enroll 10 subjects with mild persistent asthma who     are not receiving treatment with a controller therapy.   "
238725|NCT00980733|"     To evaluate the efficacy of consumption of yoghurt fortified with 30% recommended dietary     allowance (RDA) of essential micronutrients (iron, zinc, vitamin A and iodine) for a period     of one year in comparison to same yoghurt without fortification for change in mean levels and     proportion deficient for markers of status of Iron (Hemoglobin, Serum ferritin, Serum     transferrin, ZnPP), Vitamin A (Plasma retinol levels), Iodine (Urinary iodine levels), Zinc     (Plasma zinc), and copper (Plasma copper levels, sub sample of children); improvement in     cognitive development, reduction in episodes/days of illnesses (diarrhea, pneumonia, febrile     illness), hospitalizations and morbidity causing absenteeism from school and improvement in     growth. Additionally to evaluate the efficacy of consumption of fortified and non fortified     yoghurt (plain yoghurt) for a period of 12 months in comparison to pure control that do not     receive any intervention in the improvement in cognitive development and physical growth. The     main objective is to evaluate the impact of addition of micronutrients to Yoghurt and can be     best addressed by RCT. The effect of taking yoghurt per se cannot be blinded so for that the     investigators have included a concurrent control.      Hypothesis: Consumption of fortified yoghurt with 30% RDA of essential micronutrients (iron,     zinc, vitamin A and iodine) for a period of one year will improve the micronutrient status     indicators, cognitive development, and growth and reduce morbidity of children.   "
238726|NCT00980746|"     The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL)     as therapy for patients with painful diabetic neuropathy.   "
238727|NCT00980759|"     This study is an open-label, multi-institutional, randomized phase II study, which is     designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing     recurrences at the para-aortic lymph node (PAN), and also on improving disease-free survival     of locally advanced uterine cervical cancer. Radiotherapy is given as a conformal technique     based on the individually taken CT scan and cisplatin is given concomitantly with     radiotherapy in both EFI arm and pelvis only treatment arm. According to our past study     result, patients with more hypoxic tumors are more likely to develop distant metastasis     including the recurrences at PAN (1-3). This study started with examination of CA9 (hypoxia     marker) expression in the primary cervical tumor before randomization because it was expected     that there would be a differential benefit of EFI in patients with CA9-positive vs     CA9-negative tumors. However, the study design was modified because there was too much delay     in the patient with CA9-negative tumors. The patients are now registered and then immediately     randomized to experimental (EFI) and control arm (pelvis only treated) with examination of     CA9 expression at later time.   "
238728|NCT00980785|"     Angiotensin converting enzyme inhibitors (ACE-I) are a group of blood pressure-lowering     medicines. Some studies suggest that ACE-I, such as ramipril, may help prevent Alzheimer's     disease (AD). The purpose of the research is to see how ramipril affects a substance in the     body called beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the     brain and spinal cord. High amounts of beta-amyloid may be associated with a greater risk of     getting Alzheimer's disease. This study will see if ramipril can lower the amount of     beta-amyloid in the spinal fluid. This study will also see if ramipril affects blood vessel     function and memory and thinking. The investigators hope that future studies will show     whether ramipril might prevent memory loss and decrease the chance of developing Alzheimer's     disease.   "
238729|NCT00980798|"     This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a     once-daily formulation of a strong opioid against placebo in patients, who are suffering from     pain due to osteoarthritis of the hip or the knee and who previously did not receive any     strong opioids.The clinical trial tests the effect of the treatment on symptoms of pain,     stiffness and physical function. The effect of the treatment on parameters on health related     quality of life as well as quality of sleep will be measured.   "
238730|NCT00980824|"     Scotland has higher rates of suicide than other parts of the UK, an average rate of 15.1 per     100,000 in Scotland compared to 11.4 for England and Wales. The Scottish Government is     committed to reducing suicide by 2013. Choose Life has led to staff in services such as     Accident and Emergency (A&E) receiving recent training in suicide prevention through ASIST     and STORM.      Evidence for interventions specific to A&E setting is limited despite the fact that this is     the most likely point of first contact with health services for people at risk of this     behaviour. Brief interventions that reduce repetition of self harm have not been particularly     effective partly because of poor attendance and lack of focus on comorbidity. We propose to     pilot an evaluation of a brief focused intervention, ENGAGE (based on MAnualised Cognitive     Therapy,MACT, developed by the investigator (Kate Davidson) and Prof Ulrike Schmidt of the     Institute of Psychiatry, London) for those who present at A&E with a suicide attempt and who     have a complex presentation - a combination of substance abuse and or personality disorder,     all of which are recognized as high risk factors for suicide. ENGAGE will specifically     encourage patients to seek appropriate services to meet their mental health needs. This pilot     will allow us to assess the feasibility of a full scale study.   "
238753|NCT00981162|"     This phase I/II trial is studying the side effects and best dose of everolimus when given     together with sorafenib tosylate and to see how well they work in treating patients with     advanced solid tumors and metastatic pancreatic cancer that does not respond to gemcitabine     hydrochloride. Sorafenib tosylate and everolimus may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the     growth of pancreatic cancer by blocking blood flow to the tumor. Giving sorafenib tosylate     together with everolimus may kill more tumor cells.   "
238731|NCT00980850|"     In the first half of this year a novel Influenza A H1N1 virus has resulted in an influenza     pandemic. The United Kingdom has seen a particularly high incidence of disease. The highest     rates of disease are being seen in young children. In anticipation of an influenza pandemic     two vaccine manufacturers, Baxter and GlaxoSmithKline, have gained marketing authorization     approval from the European Medicines Agency (EMEA) for a pandemic strain vaccine under the     mockup dossier route based on limited clinical trial data for a candidate H5N1 vaccine.     This mockup dossier route for pandemic influenza vaccines allows the submission of a core     pandemic dossier during the interpandemic period, which results in the approval of a mockup     pandemic vaccine. This is followed by a fast track approval of the pandemic vaccine based on     the submission of the pandemic variation when the situation arises. The Baxter and     GlaxoSmithKline vaccines have now been modified to cover the novel influenza A H1N1 strain.      Given the high rates of swine flu disease in children, this age group is likely to     particularly benefit from immunization against this virus, however there are few data on the     use of these vaccines in a pediatric population. The proposed study therefore aims to assess     the immunogenicity, safety, and tolerability of these two H1N1 vaccines when administered as     two doses three weeks apart to children aged 6 months to 12 years of age.   "
238732|NCT00980863|"     Patients with bipolar disorder are at increased risk of weight gain, which in turn, increases     the risk for somatic disease and non-adherence to maintenance therapy. Therefore,     interventions addressing weight gain are expedient for the management of this disorder. The     investigators set out to evaluate the effects of a lifestyle intervention on body mass index,     cardiovascular, glycemic and metabolic parameters in patients with bipolar disorder under     mood stabilizing pharmacological treatment. 50 outpatients with bipolar disorder under mood     stabilizing treatment participated in a randomized controlled trial (waiting control group     N=24 and multimodal lifestyle intervention N=26). Each experimental group consisted of two     cohorts. The intervention lasted five months and consisted of eleven group sessions and     weekly fitness training. Body Mass Index (BMI), body weight as well as cardiovascular,     glycemic and metabolic parameters were determined as baseline (March and September 2005) and     after five (July 2005 and January 2006) and eleven months (January and July 2006).   "
238733|NCT00980876|"     The objective of this study is to compare the efficacy and safety profiles of the test     product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of     hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.   "
238734|NCT00980889|"     Less than 20% of patients with malignant distal bile duct (BD) obstruction (often pancreatic     cancer) are suitable for resection surgery.In the rest,palliation treatment comes into focus.     Jaundice caused by BD obstruction gives pain, infection (cholangitis), often itching and     increased weight loss, and the patient is stigmatized by the deep yellow colour of the     skin.Therefore palliation with endoscopic stenting by ERCP-technique is important. Modern     self-expanding metal stents (SEMS) are now widely used in this context. Comparison in a RCT     between steel and nitinol SEMS has never been performed.      The steel stent (Wallstent®) is the original,is widely used, and has more expanding power.     Nitinol stents are softer and claimed to be easier to insert,and are more and more popular.A     newly developed nitinol stent (Wallflex®)may have these advantages, but is some 120 Euros     more expensive.      Regarding the most important outcome measure, time to stent failure (obstruction), no one     knows if there is any difference.Our hypothesis is that there is no difference in this main     outcome endpoint.   "
238735|NCT00980915|"     The purpose of the study is to identify the patients at high risk of developing Acute Lung     Injury (ALI) at the time of hospital admission, and before intensive care unit admission.      Aim 1- To validate the prediction model (Lung Injury Prediction Score) in a population based     sample of hospitalized patients.      Aim 2- To determine the significance of health-care related ALI risk modifiers in a     population based sample.      Aim 3- To compare the short and long term outcomes between patients at high risk who do, and     do not develop ALI.   "
238736|NCT00980941|"     The investigators hypothesize that different types of starch vary in their effects on     appetite, blood sugar and food intake. In this study, subjects consumed five soups containing     50 g of whole grain, high amylose corn, regular corn or maltodextrin starches or no added     starch at one week intervals. The investigators measured food intake at 30 minutes, appetite     and blood sugar.   "
238737|NCT00980954|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.     It is not yet known whether chemotherapy and radiation therapy are more effective when given     with or without additional chemotherapy in treating cervical cancer.      PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation     therapy to see how well they work when given with or without additional chemotherapy in     treating patients with high-risk early-stage cervical cancer after radical hysterectomy.   "
238738|NCT00980967|"     Obliterative Bronchiolitis (OB) is the major cause of long-term lung allograft loss for     patients with end stage pulmonary diseases like cystic fibrosis. Numerous cells and proteins     are implicated in this process, which have never been studied prospectively in a multicentric     longitudinal cohort. The aim of this study is to detect predictive risk factors of OB through     a national multicentric cohort of 500 newly transplanted recipients (COLT). COLT will consist     in a large database, associated with a recipient bio-collection, and specific projects using     these resources. COLT will aggregate all the 11 French centres of pulmonary transplantation.     Patient will be followed-up during 5 years. Blood samples will be obtained. Induced sputum,     bronchoalveolar lavage fuid, exhaled breath condensate and trans bronchial biopsies will be     also taken. T cells, known to be involved in chronic rejection will be studied, and genomic,     microarray and proteomic approaches will be used to detect further predictive factors. A     study on Circulating Endothelial Cells and Circulating Endothelial Progenitors is also     realised from blood samples. COLT will prove molecular markers to be predictive of early OB,     before the development of severe airway obstruction and will allow the identification of     patients at high risk of OB. COLT will identify potential targets for future treatments of     OB. This collaborative project makes research and clinical teams working together, and     creates the conditions of a long term network, extendable to other laboratories with new     projects and additional European transplant centres.   "
238739|NCT00980980|"     The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA     (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three     strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care     units. The three strategies to be evaluated are:        -  screening on admission followed by isolation of MRSA+ patients        -  screening on admission followed by isolation and decolonization of MRSA+ patients        -  universal decolonization on admission with no screening. The decolonization regimen          involves bathing with chlorhexidine plus intra-nasal application of mupirocin. The main          outcome will be MRSA+ clinical cultures.      The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital     Corporation of America.   "
238740|NCT00980993|"     Patient anatomy and position during the course of radiation therapy can vary from those used     for treatment planning; a function of patient movement, uncertainty in positioning system,     and organ motion. Traditionally, treatment margins are designed to compensate for     interfraction prostate setup variability. This approach has the potential to lower the     overall effectiveness of treatment because the prostate gland is a continuously moving target     whose motion cannot be accurately accounted for solely on the basis of interfraction     movement. More recently, the dosimetric relevance of intra-fraction prostate motion has been     recognized, and may be compensated for by continuous real-time adaptive radiation therapy     afforded by the Calypso 4D Localization System™. In the current study, the investigators     propose to characterize intrafraction prostate motion. The investigators hypothesize that     intrafraction prostate motion is correlated with respiratory motion.   "
238741|NCT00981006|"     The aim of this study is to evaluate the safety and efficacy on the transplantation of     autologous human cardiac-derived stem cells (hCSCs) with the controlled release of basic     fibroblast growth factor (bFGF) to severe refractory heart failure patients with chronic     ischemic cardiomyopathy concordance with reduced left ventricular dysfunction (15%≦LVEF≦35%).   "
238742|NCT00981019|"     The probably most commonly used measure for expressing the pay-offs of early detection and     treatment are survival rates. Yet, over time and groups this metric comes with several biases     and thus, is not reliable for judging such benefits. Epidemiologists recommend using     reduction of disease-specific mortality rates instead, which is unbiased. The purpose of the     study is to investigate how primary care physicians understand and use different survival     measures for determining the benefit of cancer screening tests.   "
238743|NCT00981032|"     The investigators' aim is to implement an intervention to increase aspirin prophylaxis use     among patients that is patient initiated, optimizes use of physician and staff time,     appropriately compensates staff, provides clinicians with tools necessary for managing     aspiring prophylaxis, and ensures continuous management.   "
238744|NCT00981045|"     The primary objective of this study is to examine the efficacy and safety (cardiovascular) of     an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron     sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal     function.   "
238745|NCT00981058|"     The research study is testing the investigational drug necitumumab (IMC-11F8) in the     treatment of advanced non-small cell lung cancer. The aim of this study is to determine if     necitumumab, given together with a standard chemotherapy combination consisting of cisplatin     and gemcitabine will be more effective in improving participant disease than the standard     chemotherapy combination alone.   "
238746|NCT00981071|"     The aim is to evaluate the time of positive conversion after exposure to smear positive     pulmonary tuberculosis (TB) in a platoon of Korean military, a closed communal setting.   "
238747|NCT00981084|"     The investigation will involve a double-blind, placebo controlled, cross-over study examining     the efficacy of armodafinil in improving neurocognitive functioning and reducing cognitive     fatigue in MS. Patients who report MS-related cognitive difficulties and perform at least 1     standard deviation below the mean on a brief cognitive screen will be given a thorough     neuropsychological evaluation at two time points. Half of the patients will be randomized to     receive a single oral dose of lactose placebo prior to the first testing session. After a     washout period of one week, they will then receive 250mg of armodafinil prior to a second     testing session (P/A group). The other half of patients will be randomized to receive the     active drug first. After a washout period of one week, they will receive the placebo prior to     a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours     after administration, participants will be asked to take a single 250mg capsule 2 hours prior     to the scheduled testing sessions.   "
238748|NCT00981097|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This research study is looking at blood and tissue samples from patients with     aggressive non-Hodgkin B-cell lymphoma or Hodgkin lymphoma.   "
238749|NCT00981110|"     The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing     in comparison with the efficacy of standard dressing in terms of prevalence of surgical site     infections (SSI) in patients who underwent colorectal resection for malignancy.   "
238750|NCT00981123|"     Observational, non-comparative, epidemiological study to collect and analyse real life data     on schizophrenic patients receiving quetiapine according to the standard medical practice in     Croatia. The main objectives are to assess after 6 months of quetiapine therapy severity of     illness and global improvement in patients using Clinical Global Impression (CGI) scale.   "
238751|NCT00981136|"     This is a prospective trial of single incision versus standard 3-port laparoscopic     appendectomy.      The hypothesis is that there may a difference in wound infection rates, operative time, doses     of analgesics post-operatively, and patient/parent perception of scars.   "
238752|NCT00981149|"     Temporomandibular joint disorders (TMJD) are a family of musculoskeletal disorders that     represent the most common chronic orofacial pain condition. TMJD is associated with     persistent pain in the region of the temporomandibular joint and muscles of the head and     neck. The purpose of this study is to test duloxetine (Cymbalta) as a potential treatment for     chronic facial pain. Duloxetine is FDA approved as an antidepressant and for the chronic pain     conditions of fibromyalgia and diabetic neuropathy. Chronic facial pain may be linked to     Temporomandibular Joint Disorder (TMJD) which currently has no standard treatment.   "
238754|NCT00981175|"     The purpose of this study is to assess the safety, tolerability, immunogenicity, and duration     of immunity of one or two doses of ChimeriVax™-JE vaccine separated by 5 or 6 months in     adults.      Objectives:      Safety:        -  Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE compared          with a placebo in adult volunteers (≥ 18 to <55 years) without prior Japanese          encephalitis (JE) vaccination.      Immunogenicity:        -  Obtain data on the antibody response in adult volunteers following administration of          ChimeriVax™-JE        -  Assess the durability of the immune response in adult volunteers over 60 months          following one or two doses of ChimeriVax™-JE.   "
238755|NCT00981201|"     The purpose of this study is:        -  To examine the effect of celecoxib treatment on Ki-67 expression, a marker of cell          proliferation, in the bronchial epithelium of current and former smokers.        -  To examine the toxicity associated with celecoxib administration.        -  To measure the effect of celecoxib treatment on arachidonic acid metabolites in the          bronchial epithelium of current and former smokers.   "
238756|NCT00981214|"     This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand)     pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic     fibrosis (CF) and exocrine pancreatic insufficiency (EPI).   "
238757|NCT00981227|"     The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL)     as therapy for patients with post-herpetic neuralgia.   "
238758|NCT00981240|"     Primary objectives:        -  To determine the maximum tolerated dose (MTD) of SAR103168 and to characterize the dose          limiting toxicities (DLTs) in the proposed dose regimen        -  To evaluate the pharmacokinetic (PK) profile of SAR103168      Secondary objectives:        -  To characterize the global safety profile of SAR103168        -  To evaluate preliminary anti-leukemia activity        -  To investigate the potential induction effect on CYP3A4 and persistence of this effect          by using oral midazolam as a probe substrate in patients enrolled into the expanded          cohort at the MTD        -  To determine the metabolic pathways of SAR103168 and identify the chemical structures of          metabolites        -  To determine the potential impact of SAR103168 on the QTc interval in patients enrolled          at the MTD   "
238759|NCT00981253|"     The purpose of this study is to assess the extent to which combining exercise and stress     management training (SMT) is more effective at improving biomarkers in vulnerable cardiac     patients compared to exercise-based cardiac rehabilitation alone.   "
238760|NCT00981266|"     The purpose of this study is to demonstrate safety and effectiveness of Mentor's     Spectra/Becker 80 Adjustable Breast Implants in women who are undergoing primary or revision     breast augmentation. Safety information on the rate of complications, such as infection, will     be collected and used to help determine device safety. These implants are investigational     devices.      Approximately 450 patients at sites across the United States will be enrolled in this     research study by up to 30 sites. These patients will be implanted with Spectra/Becker 80     implant and monitored for 10 years to collect information on risks associated with the     implant surgery as well as changes in the way these patients feel about themselves.   "
238761|NCT00981279|"     The aim of this study was to delineate the epidemiological profile of HIV seropositive     patients on antiretroviral therapy at the Clinical Hospital of the Federal University of     Goiás.   "
238762|NCT00981292|"     Epigallocatechin gallate (EGCG) is the most abundant catechin (sometimes referred to as tea     flavonoids) in green tea extract. A review by Nagle et al (2006) identifies that a large     amount of research indicates EGCG (amongst other catechins) is responsible for most of the     potential health benefits associated with green tea. EGCG is brain permeable (Nakagawa &     Miyazawa, 1997), and it is considered to have neuroprotective and neurorescue effects     including modulation of cell survival and cell cycle genes (Levites et al 2002).      Although there have been several human studies looking at the bioavailability of EGCG when     administered in varying doses, there have been no studies that have specifically investigated     the cognitive effects of this catechin in humans. Therefore, the purpose of this study is to     assess the cerebral blood flow (using Near Infrared Spectroscopy), cerebro-electrical     activity (EEG) and behavioural effects of EGCG. A randomised, double-blind,     placebo-controlled, balanced crossover study will assess the effects of 135 mg and 270 mg     pure EGCG in 24 healthy, young adults (18-35). Prior to the first active study day     participants will attend a screening/training visit where relevant exclusion criteria will be     assessed including any food sensitivities. They will also complete a caffeine consumption     questionnaire in order to control for potential caffeine withdrawal effects as a result of     restrictions of the study.   "
238763|NCT00981305|"     The purpose of this study is to determine whether lactate-containing vaginal lubricant is     effective in the treatment of young breast cancer survivors with sexual dysfunction.   "
238764|NCT00981318|"     This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no     nucleoside medications) in HIV patients failing their initial antiviral therapy.   "
238765|NCT00981331|"     The purpose of the study is to determine whether manipulation of the subtalar joint (one of     the two joints of the ankle) has an effect on ankle range of motion in a group of ankles that     have sustained a subacute inversion ankle sprain.      The investigators expect subtalar joint manipulation will increase ankle range of motion     about the subtalar joint, but not at the talocrural joint (the other joint of the ankle).   "
238778|NCT00981500|"     The investigators wish to study the effects of three forms of bariatric surgery: Roux-en-Y     gastric bypass, Sleeve Gastrectomy, and Gastric Banding. The surgery is not part of the     clinical trial. If your insurance does not cover the procedure, then you are responsible for     payment of the surgical process. We are doing pre and post surgery testing to provide a     better understanding of the effect of bariatric surgery-induced weight loss on metabolic     function.   "
238779|NCT00981513|"     The purpose of this study is to determine the degree of indirect benefits to family members     and classmates resulting from administration of influenza vaccine to children.   "
238810|NCT00974025|"     In this study, investigators will evaluate the effect of vitamin C on endothelial function,     exercise tolerance and quality of life in patients with a single ventricle who have been     palliated to Fontan physiology. The hypothesis is that vitamin C will result in improved     exercise tolerance and endothelial function in patients who have undergone the Fontan     operation, compared to placebo.   "
238766|NCT00981344|"     The project will examine how mobility performance in real life tasks and environments is     impacted by the use of specific types of wheeled mobility devices (wheeled walker, manual     wheelchair, power wheelchair/scooter). Specifically, the project will: 1) randomly recruit     persons who were prescribed a mobility aid within the preceding 1 year and currently use the     mobility aid, 2) define key mobility tasks within a public environment, 3) measure mobility     performance of subjects as they perform the mobility tasks in each of the four devices, and     4) synthesize and disseminate the results. Study results will be used to establish baseline     performance data for researchers and clinicians and to identify design improvements for     wheelchairs used by community dwelling elders.      All study participants will be required to complete study related questionnaires about their     family environment and familiarity with the various types of mobility aids. In addition,     physical abilities will be measured at the start of the study, including measures of arm and     leg strength, and the ability to walk and push a wheelchair. This will take about 30 minutes.     A total of 150 subjects will be recruited among Veterans prescribed mobility aids in the     preceding 3-12 months identified through administrative data sources.      The mobility aids being studied are all standard types of mobility aids used by people with     limited mobility (e.g., wheeled walker, manual wheelchair, power wheelchair/scooter).     Analyses will proceed in a stepwise fashion. The first step will be to examine the primary     study question relating device type to the dependent variable, with velocity being the     primary outcome. The next step in the analysis will be to determine if there is an     interaction between medical condition, mobility devices, and the dependent variable. Finally,     exploratory analyses will be carried out to examine the relationship between baseline     measures of physical function and mobility performance with each of the devices. Study     related risks are minimal.   "
238767|NCT00981357|"     Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain     and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme     in animals and healthy human volunteers. The purpose of this study is to evaluate whether     PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and     whether this results in these patients experiencing less pain.   "
238768|NCT00981370|"     Hypothesis:      The investigators suspect that significant degrees of iron overload in subjects with SCD     result in decreased red cell survival, abnormal endothelial function and markedly     dysregulated autonomic function. Furthermore, the investigators anticipate that the magnitude     of these effects is proportional not only to the magnitude of total body iron stores but also     to the duration of exposure to the high iron levels in tissues.      Primary objective To determine if red cell survival as assessed by 51Cr red cell survival     analysis, hemoglobin level, reticulocyte count, lactic acid dehydrogenase, and plasma     hemoglobin in sickle cell patients is related to the degree of iron overload.      Secondary objective(s)        1. Determine if the magnitude of endothelial-dependant vasodilation is related to The          degree of iron overload.        2. Determine if the degree of change in cardiac beat to beat variability in response to          hypoxic exposure or to cold exposure (cold-face-test) is related the magnitude of iron          overload.      The primary measure of iron overload will be MRI determination of liver iron concentration.   "
238769|NCT00981383|"     Depressive disorders are common in patients with Coronary Artery Disease (CAD), occurring in     up to 47% of patients. Left untreated, these symptoms not only have a strong negative impact     on quality-of-life, but also increase risk of future cardiac events and death. Unfortunately,     about 64% of CAD patients do not respond to current antidepressant treatments.     Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are two omega-3 (ω-3) fatty acids     found in fatty fish that are important for brain function. Recent evidence showed that     depressed CAD patients have lower levels of EPA and DHA than non-depressed CAD patients. This     information, taken together with the known roles of ω-3 fatty acids in brain function,     suggests that deficiencies may contribute to depression. However, it is unknown if increasing     consumption of ω-3 fatty acids would alleviate depression and improve quality of life. While     intake of adequate levels of ω-3 fatty acids is difficult to obtain through diet,     concentrated supplements containing EPA and DHA that are safe, readily available, and     inexpensive are now obtainable in Canada. CAROTID (CAD Randomized Omega-3 Trial In     Depression) will randomize patients with CAD, with and without depressive symptoms, after 6     months of cardiac rehabilitation and usual care to receive either ω-3 fatty acid supplements     or placebo daily during their final 6 months of cardiac rehabilitation. The investigators     hypothesize that CAD patients randomized to receive ω-3 fatty acid supplements will show     greater improvement in depressive symptoms and quality-of-life over time. The investigators     will also evaluate possible improvements in other important determinants of quality of life:     memory and other cognitive abilities.   "
238770|NCT00981396|"     The National Health Service (NHS) stop smoking service at the Central Lancashire NHS Trust     serves a diverse population of smokers, with a very good quit rate and high standards.     However, clinical experience predicts that some clients are unlikely to succeed through the     NHS smoking cessation program. This special population has difficulty quitting for a variety     of reasons. Some relapse over the course of the following two years and return repeatedly to     the service. Others, for instance those with health problems, may be highly motivated to     quit, but unable to resist their cravings. The purpose of this study is to determine if EFT     makes a difference in quit rates with the most challenging population of clients.   "
238771|NCT00981409|"     The primary objective is to evaluate the efficacy (as measured by the rate of recurrent     symptomatic Venous Thromboembolism [VTE] (i.e., Pulmonary thromboembolism [PE] and Deep Vein     Thrombosis [DVT])) and safety of GSK576428 as the initial treatment in subjects with acute PE     in an open-label design.   "
238772|NCT00981422|"     The aim of this study was to evaluate the lymphocyte phenotype in primary open- angle     glaucoma (POAG) patients compared to healthy subjects of the same age, in order to confirm     the importance of immune responses in glaucoma and the possible correlation to the severity     of the disease.   "
238773|NCT00981435|"     The purpose of this study is to determine whether the choice of post-operative eye drop     administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in     lowering intraocular pressure (IOP).   "
238774|NCT00981448|"     The purpose of this study is to evaluate the effect of zinc supplementation on insulin     secretion by genotype of SLC30A8.   "
238775|NCT00981461|"     The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 beam     model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment     is applied as directed.   "
238776|NCT00981474|"     Neurological complications from cardiac surgery are an important source of operative     mortality, prolonged hospitalization, health care expenditure, and impaired quality of life.     New strategies of care are needed to avoid rising complications for the growing number of     aged patients undergoing cardiac surgery. This study will evaluate novel methods for reducing     brain injury during surgery from inadequate brain blood flow using techniques that could be     widely employed.   "
238777|NCT00981487|"     This study is to assess the effect of food on a single dose of Ondansetron when taken with a     meal on an empty stomach.   "
238781|NCT00981539|"     Traditionally, many gynecologic surgeons have asked patients to perform a cleansing enema the     night before a vaginal surgery done to repair pelvic organ prolapse (dropped bladder, dropped     uterus). The belief is that there is then less or no stool present at the vaginal incision     and less chance of infection of the wound by bowel bacteria. However, not all surgeons follow     this practice. There is no evidence in the medical literature if one way is better than the     other. In this study, patients scheduled for vaginal surgery to correct prolapse will be     randomly assigned to perform an enema or not to perform an enema.   "
238782|NCT00981552|"     A theoretical planning study to compare the normal tissue irradiation when using intensity     modulated radiotherapy (IMRT) as opposed to standard radiotherapy for the definitive     treatment of cervical cancer.   "
238783|NCT00981565|"     Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment. Diagnosis is     based on symptoms, clinical findings and electrophysiological examination. Several     conservative and surgical treatment options have been described.      Studies of surgical versus conservative treatment in mild carpal tunnel syndrome have not     been done and it is still unclear whether or not surgical treatment is better than     conservative treatment.      The aim of this study is to research has surgery better outcome in mild CTS than conservative     treatment. Patient satisfactory, clinical and electrophysiologic outcomes, direct and     indirect costs will be evaluated.   "
238784|NCT00981578|"     A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone     System in the treatment of pain resulting from metastatic bone tumors.   "
238785|NCT00981591|"     The purpose of this study is to determine whether inhaled iloprost is safe and effective in     pediatric patients with pulmonary hypertension who are sick in the intensive care unit.   "
238786|NCT00981604|"     Prospective randomized trial of single incision versus standard 4 port laparoscopic     cholecystectomy. Hypothesis is that the operative time will be longer with single incision.   "
238787|NCT00981617|"     This study will evaluate the safety and efficacy of ALKS33 (RDC-0313) compared with placebo     in adults with alcohol dependence. There will be 11 study visits conducted over a period of     about 4 months. The study period includes a screening visit, a 12-week treatment period, and     a follow-up visit.   "
238788|NCT00981630|"     The purpose of this study is to assess the safety, tolerability, and immunogenicity of a new     formulation of lyophilised ChimeriVax™-JE, given at three dose levels, compared with placebo.      Primary Objectives:      Safety:        -  To obtain safety and tolerability data for a single subcutaneous vaccination with          ChimeriVax™-JE, at three dose levels, in healthy adult volunteers (18-49 years old).      Immunogenicity:        -  To obtain data on the antibody response to a single subcutaneous vaccination with          ChimeriVax™-JE, at three dose levels, in healthy adult volunteers without prior Japanese          encephalitis immunity.        -  To assess the durability of immune response up to 12 months following a single          subcutaneous vaccination with ChimeriVax™-JE, at three dose levels.   "
238789|NCT00981643|"     This study will evaluate the effects of mindfulness and concentration meditation on pain,     fatigue, and physical functioning in patients with either multiple sclerosis or peripheral     neuropathy.   "
238790|NCT00981656|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more     tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as     cisplatin, mitomycin C, and fluorouracil, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving radiation     therapy together with cisplatin may kill more tumor cells.      PURPOSE: This phase II trial is studying how well radiation therapy given together with     chemotherapy works in treating patients with stage I bladder cancer.   "
238791|NCT00981669|"     The purpose of this study is to describe the safety, tolerability and immunogenicity of the     pentavalent rotavirus vaccine produced by Butantan Institute.   "
238792|NCT00981682|"     The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic     patients.   "
238793|NCT00981695|"     Objectives:      Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants     born to HIV-1-infected mothers.      Secondary:        -  HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control          arms in each cohort (breastfeeding or formula feeding)        -  HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants          receiving MVA.HIVA        -  HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants in the          age-matched unvaccinated control group        -  Comparison of responses to certain Kenyan Extended Programme on Immunization (KEPI)          vaccines (OPV, DTP, HBV, and HiB) between MVA.HIVA versus age-matched unvaccinated          controls in each cohort, between breast versus formula feeding infants in the          age-matched unvaccinated control group, and between breast versus formula infants          receiving MVA.HIVA        -  Comparison of immune activation and phenotypic profile of lymphocytes between breast and          formula feeding infants in each cohort (MVA.HIVA and age-matched unvaccinated control)        -  Build capacity for Infant HIV-1 Vaccine Clinical Trials Centre in Nairobi, Kenya.   "
238794|NCT00981708|"     The purpose of this study is to determine the safety and activity of the combination of     lenalidomide with intermediate dose dexamethasone and cyclophosphamide in patients with     primary systemic (AL ) amyloidosis.   "
238795|NCT00981721|"     This study is being carried out to see how single and multiple doses of cediranib are handled     by the body (that is how they are absorbed, broken down and got rid of from the body) by     measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.      The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and     how the tumour responds to treatment with cediranib.   "
238811|NCT00974038|"     We are interested in studying two different psychological treatments for eating disorders for     adolescents (ages 12-18). The study is designed to help adolescents who are having problems     with binge eating and/or purging. The treatment consists of 14 sessions of approximately     one-hour each over about three months.   "
239436|NCT00982488|"     This study assesses the long-term safety and tolerability of dasatinib administered to     patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute     lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or     imatinib in previous protocols.   "
238796|NCT00981734|"     This is an experimental research study. The subjects were randomized into two groups:     Experimental group (EG; n=58, age: 67 ± 6 old) and Control group (CG; n=40; age: 70 ± 6 old).     All were physically active without strictly obeying in regularity of the program of physical     activity.      The functional autonomy was evaluated by the amount of tests of Group Development of Latin     American Maturity (GDLAM). It consists of hiking ten meters (C10m); standing up from the     sitting position (SSP); to stand up from the ventral decubitus position (SSPVD); to stand up     from a chair and be able to walk around your home (SCWH); and to be able to wear and remove a     t-shirt (DTS). These tests have showed similar results in indice of GDLAM (IG). The     intervention took place three times a week, with intensity that has varied between fifty five     to seventy five per cent of the frequency maximum from heart.   "
238797|NCT00981747|"     The purpose of this study is to determine whether combination therapy with sildenafil and     losartan can improve function and exercise tolerance in patients with idiopathic pulmonary     fibrosis.   "
238798|NCT00981773|"     The aim of the study is to determine whether switching from an antiretroviral regimen     containing abacavir and/or didanosine to one containing maraviroc will lead to a reduction in     platelet reactivity and inflammatory markers at weeks 12 and 24 thereby conferring a     reduction in cardiac risk.      In addition the study will assess the efficacy of a maraviroc containing regimen in     combination with a boosted protease inhibitor in terms of tolerability and achieving long     term viral suppression as assessed at week 48.      The investigators hypothesize that there will be a rapid reduction in platelet reactivity on     switching to maraviroc and that a boosted protease inhibitor in combination with maraviroc     will provide a safe and efficacious antiretroviral regimen enabling a reduction in cardiac     risk whilst maintaining virological suppression.   "
238799|NCT00981786|"     The proposed crossover study will compare for the first time the quality of 24-hour     intraocular pressure control with the combination of travoprost and brinzolamide/timolol     compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently     controlled with travoprost. This comparison may determine the real efficacy of the two fixed     combinations when added to the prostaglandin. The design of the proposed study should     facilitate a better understanding of the role of these medications in glaucoma management.   "
238800|NCT00981799|"     Nelarabine has shown significant activity in patients with T-cell malignancies. This study     will determine the safety and maximum tolerated dose of the combination of nelarabine,     cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first     relapse of T-LL.   "
238801|NCT00981812|"     The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy     Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on     suspicious lesions. This study will also allow the doctors to describe the features of PEM     detected lesions and the results obtained using the PEM guided biopsy and will compare the     time it took to complete a pre-operative work up using PEM versus MRI in patients with a     suspicious breast lesion resulting in cancer.   "
238802|NCT00981825|"     Research study to compare the effects of brushing with two commercially available toothpastes     on salivary bacteria after brushing   "
238803|NCT00981838|"     Background. Patients, especially children, with steroid-dependent or multirelapsing nephrotic     syndrome (NS) secondary to minimal change disease (MCD) or idiopathic focal and segmental     glomerulosclerosis (FSGS) on continuous treatment with steroids and/or other     immunosuppressive agents to limit or prevent recurrences are at increased risk of severe     drug-related adverse events. Case reports suggest that Rituximab, a B cell depleting     monoclonal antibody, could be a safe and effective alternative to steroid or     immunosuppressants to achieve and maintain remission in this population.      Objectives. The study is primarily aimed at evaluating whether Rituximab may maintain stable     NS remission after tapering and withdrawal of steroid and immunosuppressive therapy in     patients with MCD or FSGS and steroid-dependent or multirelapsing NS. Secondarily, the study     will assess whether Rituximab allows reducing maintenance doses of steroids and other     immunosuppressants (in those who relapse), thus limiting treatment related side effects and     costs.      Methods. This prospective, sequential, open, study will include 20 patients with histology     evidence of MCD or FSGS and steroid-dependant or multirelapsing NS, who are on stable     complete or partial remission since at least 1 month and, based on their previous history,     are expected to invariably relapse after steroid/immunosuppression withdrawal. After baseline     evaluation of clinical, laboratory and kidney function parameters [including glomerular     filtration rate (GFR), renal plasma flow (RPF), albumin and sodium fractional clearance and     the glomerular albumin permeability assay (Palb)], patients will receive one Rituximab     infusion that will be repeated 1 week later if CD20 cells are not fully depleted from the     circulation. Then ongoing immunosuppression will be progressively tapered up to complete     withdrawal over 6 to 9 months. 24h proteinuria will be monitored monthly and spot urine will     be tested daily by albustix to early detect disease relapses. Baseline evaluations will be     repeated at study end (1 year). Relapses will be treated with high-dose steroids as per     center practice and the last immunosuppressive therapy effective in preventing disease     reactivation will be reintroduced.      Expected results. Rituximab is expected to prevent NS recurrence following tapering and     discontinuation of steroid and other immunosuppressants. Maintaining remission without     chronic immunosuppression is expected to minimize risks and costs of therapy and to     remarkably improve patient outcomes.   "
238804|NCT00981851|"     The final purpose of this study is to determine whether bronchodilation and cigarette smoking     in Chronic Obstructive Pulmonary Disease (COPD) patients interact, resulting in an increase     of cardiovascular disease. The aim of this part of the study is to demonstrate the basic     mechanism: Does increased respiratory function after administration of a bronchodilator in     patients with COPD lead to elevated pulmonary retention of the harmful compounds in inhaled     cigarette smoke and to short-term biological effects associated with cardiovascular disease?   "
238805|NCT00981864|"     The primary aim of this study is to evaluate the feasibility of delivering 42.5 Gy to the     breast with a concomitant 10 Gy boost to the tumour bed in 16 fractions for a total duration     of 3.5 weeks using intensity modulated radiotherapy (IMRT). The primary end-point is the     proportion of patients treated without major treatment deviation.   "
238806|NCT00981877|"     The purpose of this study is to determine the effect of probiotics in rotavirus acute     diarrhea in children. The investigators will compare the effect of two different probiotics     products.   "
238807|NCT00981890|"     The purpose of this study is to determine the maximum dose of sunitinib that can be tolerated     when treatment is combined with radiotherapy. Patients who decide to take part in the study     will start taking sunitinib alone for 7 days. On the seventh day of taking sunitinib,     patients will be given stereotactic radiosurgery (SRS).      The dose of radiation that patients will receive when they are given SRS is a standard dose     used to help shrink brain metastases. The dose of radiation and the way it is delivered is     not experimental.      Patients will then continue to take sunitinib seven days per week after SRS, and depending on     how far along the study is when they join, they may continue taking the drug for up to 13     weeks after SRS. Patients will undergo weekly assessment during study treatment.   "
238812|NCT00974051|"     The investigators hypothesize that the use of an oral dose of Terbutaline or a 20% basal     reduction will be able to prevent nocturnal hypoglycemia after an afternoon exercise session.     This is a randomized three period cross-over study including treatment with Terbutaline, a     20% basal reduction for six hours, or no treatment (control).   "
238813|NCT00974064|"     Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD,     commonly known as chronic bronchitis and emphysema). Despite this clear link, only 15-20% of     smokers develop COPD suggesting that genetic factors affect the lung's susceptibility to the     stress of cigarette smoke. The cells lining the airways (epithelium) and cells that help     defend the lung (alveolar macrophages) of smokers develop gene expression changes that are     different from that of nonsmokers. In the investigators' previous studies they have     demonstrated that there are greater than 200 genes that are responsive to cigarette smoke in     these cells. But the investigators do not know whether the gene expression is static or     changes as a function of time. Genes that show significant changes over time may be relevant     to the progression of the disease. Even though quitting smoking reduces the rate at which the     lungs decline, many-smokers still go on to develop COPD. This study will provide insights     into the natural history of smoking-related gene expression of the lung cells in health and     disease.   "
238814|NCT00974077|"     The study investigates cognitive attention, rumination and psychophysiological (EEG)     processes in healthy subjects and remitted patients with at least three previous depressive     episodes. The investigators expect that Mindfulness Based Cognitive Therapy prevents future     depressive episodes and has influence on cognitive and psychophysiological measures.   "
238815|NCT00974090|"     The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in     combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration     and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an     extension treatment for up to 52 weeks.   "
238816|NCT00974103|"     The purpose of this study is to identify how many females have persistent low back pain     and/or pelvic pain 3-6 months post partum. The females that have persistent pelvic pain can     continue in the study and be examined by a chiropractor. They will then divide the females     into Hanne Alberts 5 subgroups of pelvic pain. The females that have one-sided pelvic pain     will be invited to participate in a randomised controlled study where chiropractic     intervention is compared to exercises.   "
238817|NCT00974116|"     The number of children who are obese in the UK is steadily increasing with both short and     long term consequences for health. The aim of this study is to determine whether the MEND     Programme (a new national initiative for the treatment of childhood obesity) is a successful     and sustainable treatment for childhood obesity and obesity related health problems.      300 overweight and obese children will be randomly assigned to start immediately on the MEND     Programme for 6 months or join a waiting-list control group for 6 months. Measurements of     health outcomes will be taken at baseline, and at 6, 12 and 24 months after the Programme.     After 6 months of waiting-list time, the control group will follow the same protocol as the     immediate starters. The researchers will be unaware (blinded) to which group each child has     been assigned to. The study will examine the effects of the MEND Programme on body     composition, cardiovascular health and psychological health.   "
238818|NCT00974129|"     The purpose of this study is to evaluate the genotype of CTCF, a proven transcription factor,     in patients with infantile hemangiomas and to monitor tumor growth. The investigators aim to     determine whether or not the CTCF genotype might serve as an early and reliable predictor of     tumor growth.   "
238819|NCT00974142|"     This is a randomized, double-blinded, placebo-controlled trial of oral Cyclosporine A (CsA)     in patients with advanced stage chronic obstructive pulmonary disease. The purpose of the     study is to evaluate the safety and effectiveness of CsA as a therapy for the adaptive immune     response in advanced stage Chronic Obstructive Pulmonary Disease (COPD).      Subjects between 45 and 80 years of age with a confirmed diagnosis of advanced stage COPD,     not responsive to conventional inhaler therapy, who meet all the study requirements, will be     enrolled in this study. A total of 30 subjects of either sex will be enrolled in this study.   "
238820|NCT00974155|"     The EMC trial investigates for the first time prospectively whether Major Depression Disorder     patients with non-improvement after 14 days of antidepressive treatment with EMC are more     likely to become remitters compared to patients treated according to current guidelines,     i.e., with a medication change after 28 days of treatment in case of non-response.   "
238821|NCT00974168|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy     may be effective in treating malignant spinal cord compression in patients who have received     previous radiation therapy to the spine.      PURPOSE: This phase II trial is studying radiation therapy in treating patients with     malignant spinal cord compression.   "
238822|NCT00974181|"     Two consecutive cohorts of subjects were each treated with the CoStar stent loaded with a     different paclitaxel dose regimen. The first 145 subjects (Arm I), enrolled between 20     January 2004 and 26 May 2004, were treated with 10 µg paclitaxel and the subsequent 137     subjects (Arm II), enrolled between 15 December 2004 and 9 March 2005, were treated with 30     µg paclitaxel. Both dose formulations eluted over 30 days (in-vitro).      Subjects in both arms completed clinical follow-up at 1, 6 and 12 months post-index     procedure, with angiographic follow-up at 6 months as outlined in the original study     protocol.      Based on results from previous studies and the initial EuroSTAR Trial results, Conor     Medsystems decided to pursue the dosage used in Arm I, 10 μg/30 days, as the commercial dose     formulation for the CoStar® stent. The EuroSTAR Trial addendum was proposed for the purpose     of evaluating the long-term clinical outcomes of the CoStar stent.   "
238823|NCT00974194|"     Many feasibility studies have been published on Single Port surgery, but no comparative     studies have shown any advantages compared to standard laparoscopy. The purpose of this study     is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies     using single port transumbilical approach and three trocars.   "
238972|NCT00983879|"     The purpose of this natural history study is to understand more about the progression of     infantile Krabbe disease, a very rare genetic disease. There is very little published     longitudinal data with only anecdotal cases. This natural history study will be important in     understanding the effect of future therapies that are presently in the preclinical phase.   "
238824|NCT00974220|"     Breathing discomfort (dyspnea) and activity limitation are dominant symptoms of chronic     obstructive pulmonary disease (COPD) and contribute to poor health-related quality of life in     this population. Several small, uncontrolled studies and published case reports have provided     evidence that inhaled fentanyl, a powerful pain relieving (opioid) medication, may be used to     effectively reduce breathing discomfort in patients with advanced disease. However, the     mechanisms of this improvement remain unclear. Therefore, the investigators plan to conduct     the first randomized, double-blind, placebo-controlled, crossover study designed to explore     the possible mechanisms of action of inhaled fentanyl on activity-related dyspnea and     exercise performance in patients with advanced COPD.   "
238825|NCT00974233|"     The purpose of this research is to evaluate a new combination of chemotherapy drugs for     CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an     intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill).      The purpose of this study is to see if giving the chemotherapy pill lenalidomide after     treatment with bendamustine and rituximab is able to prolong the period of time before the     cancer starts growing again and causing symptoms.   "
238826|NCT00974246|"     The purpose of this study is to assess the effect of treatment with Advair Diskus on     depression using the Cornell depression scale in COPD patients in the nursing home.   "
238827|NCT00974259|"     Traumatic brain injury (TBI) is a major cause of death and disability, with an estimated cost     of 45 billion dollars a year in the United States alone. Every year, approximately 1.4     million sustain a TBI, of which 50,000 people die, and another 235,000 are hospitalized and     survive the injury. As a result, 80,000-90,000 people experience permanent disability     associated with TBI. This project is designed to determine whether a device designed to     measure brain tissue oxygenation and thus detect brain ischemia while it is still potentially     treatable shows promise in reducing the duration of brain ischemia, and to obtain information     required to conduct a definitive clinical trial of efficacy.      A recently approved device makes it feasible to directly and continuously monitor the partial     pressure of oxygen in brain tissue (pBrO2). Several observational studies indicate that     episodes of low pBrO2 are common and are associated with a poor outcome, and that medical     interventions are effective in improving pBrO2 in clinical practice. However, as there have     been no randomized controlled trials carried out to determine whether pBrO2 monitoring     results in improved outcome after severe TBI, use of this technology has not so far been     widely adopted in neurosurgical intensive care units (ICUs). This study is the first     randomized, controlled clinical trial of pBrO2 monitoring, and is designed to obtain data     required for a definitive phase III study, such as efficacy of physiologic maneuvers aimed at     treating pBrO2, and feasibility of standardizing a complex intensive care unit management     protocol across multiple clinical sites.      Patients with severe TBI will be monitored with Intracranial pressure monitoring (ICP) and     pBrO2 monitoring, and will be randomized to therapy based on ICP along (control group) or     therapy based on ICP in addition to pBrO2 values (treatment group). 182 participants will be     enrolled at four clinical sites, the University of Texas Southwestern Medical Center/Parkland     Memorial Hospital, the University of Washington/Harborview Medical Center, the University of     Miami/Jackson Memorial Hospital, and the University of Pennsylvania/Hospital of the     University of Pennsylvania. Functional outcome will be assessed at 6-months after injury.   "
238828|NCT00974272|"     The primary goal of this study is to determine the acute effects of exenatide on postprandial     hypertriglyceridemia. Secondary goals are to determine whether there are additional     improvements in postprandial lipids and lipoproteins and whether (by the reduction of     hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the     pro-inflammatory potential of the postprandial period.   "
238829|NCT00974285|"     The average period of asymptomatic HIV-infection is 8 years, at this stage, CD4+ T lymphocyte     count was reduced gradually at the rate of 50~100cells/ul/year. When the CD4 T lymphocyte     count dropped below 350cells/ul and viral load increased to 105 in AIDS patients, HAART will     be carried out. But, CD4 T lymphocyte was 350~550 cells/ul, there is no intervention     measures.   "
238830|NCT00974298|"     The purpose of this study is to document the performance and clinical outcomes of uncemented     total elbow replacements involving the press-fit technique performed at the Vanderbilt Hand     Center. The press-fit use technique is often used because of complications with cement     loosening.   "
238831|NCT00974311|"     This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients     with castration-resistant prostate cancer who have been previously treated with     docetaxel-based chemotherapy.   "
238832|NCT00974324|"     The role of angiogenesis has been less clear in lymphoma than in solid tumors, in part     related to the heterogeneity of disease and technical issues. In addition to vascular     endothelial growth factor (VEGF) effects on angiogenesis and the integrity of tumor     vasculature, autocrine VEGF-receptor (VEGF-R)-mediated signaling may play a role in lymphoma.     Microvessel density, a measure of angiogenesis, is highest in peripheral T-cell lymphomas     (PTCL), followed by diffuse large B-cell (DLBCL) and intra-follicular follicular lymphoma     (FL).   "
238833|NCT00974337|"     The objective of this study is to estimate the prevalence of relative adrenal insufficiency     in preterm very low birth weight infants with and without shock.   "
238834|NCT00974350|"     This is a research study testing SABER™-Bupivacaine (an experimental pain-relieving     medication). SABER™-Bupivacaine is designed to continuously deliver bupivacaine, a common     local anesthetic, for a few days in order to treat local post-surgical pain. This study is     testing SABER™-Bupivacaine in people having surgery to repair a hernia.      The purpose of the study is to measure and compare the safety (side effects), tolerability     (ability to tolerate), and efficacy (how well it works) of two different volumes of     SABER™-Bupivacaine with SABER™-Placebo.   "
238835|NCT00974363|"     Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24     months after vaccination and the subjects who were vaccinated in the primary study will be     enrolled in this extension phase. No new subjects will be enrolled.   "
238836|NCT00974376|"     This is a clinical study to evaluate the efficacy of the medication gabapentin in treating     persons with cannabis dependence.   "
238837|NCT00974389|"     RATIONALE: Drugs used in chemotherapy, such as S-1, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Giving S-1 together with bevacizumab may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving S-1 together with bevacizumab works     as third-line therapy in treating patients with colorectal cancer that is recurrent or that     cannot be removed by surgery.   "
238873|NCT00981968|"     The purpose of this study is to investigate safety, tolerability and pharmacokinetics of     sitaxentan following single and multiple oral administrations of sitaxentan sodium in     Japanese healthy subjects.   "
238838|NCT00974402|"     The purpose of this study is to evaluate Cognitive-behavioral therapy (CBT) for     deployment-related post-traumatic stress disorder (PTSD) that can be used by behavioral     health consultants working with Service Members in the primary care clinic. CBT is a     well-researched, very effective individual (one-to-one) treatment that is designed to help     people to directly deal with traumatic events they have suffered in the past, including     combat. Many Service Members prefer to see behavioral health providers in primary care rather     than the mental health clinic. The researchers hope to learn if a brief treatment for PTSD in     primary care can be just as useful as more traditional treatment given in the mental health     clinic. This study will enroll approximately 45 participants overall; with approximately 30     participants at Wilford Hall Medical Center or Brooke Army Medical Center, and 15     participants to be enrolled at the South Texas Veterans Health Care System over a period of     one year.   "
238839|NCT00974415|"     The primary objective of this study is to demonstrate the efficacy and safety of the carbon     dioxide for subcutaneous fat reduction.   "
238840|NCT00974428|"     The objective of this study is to determine the most effective dose of Wobenzym® N versus     placebo at reducing pain severity as measured by the WOMAC pain score in subjects with     symptomatic knee osteoarthritis (OA) at 6 weeks of treatment.   "
238841|NCT00974441|"     This study will compare the relative bioavailability (rate and extent of absorption) of 500     mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that     of Depakote® ER Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult     subjects administered under fasting conditions.   "
238842|NCT00974454|"     Chinese prescriptions can inhibit viral replication according to the course of viral     replication, and the effects is similar to the effect of HAART, and even better than the     anti-viral and immune reconstitution of HAART due to its effect on improve immune system     function. Over the past decades, many researchers have screened the effective Chinese     medicines to treat AIDS.   "
238843|NCT00974467|"     The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website     to increase parent knowledge and skills.   "
238844|NCT00974480|"     Facial skin aging is a complex process combining factors such as sun exposure, smoking and     those that are believed to be inherited. Changes in the skin over time including decreased     thickness result in skin atrophy, wrinkling, sagging, yellowness and changes in pigmentation.     Redermic is a cosmetic cream that has been evaluated clinically but not in comparison to     tretinoin nor in combination with tretinoin. There is no data on the safety and efficacy of     Redermic as compared to topical tretinoin.      Rejuva is a cream currently approved by Health Canada for the treatment of photodamaged skin.     It contains 0.025% tretinoin one of the most widely studied topical product for skin aging.     Studies have shown that topical tretinoin increases collagen synthesis and epidermal     thickness thereby improving the appearance of skin aging. The efficacy of Rejuva combined     with another topical cosmetic cream such as Redermic in the treatment of skin aging is     unknown.      One hundred and twenty (120) subjects with signs of skin aging participated in this     single-blind study to evaluate the efficacy and tolerance of Redermic versus Rejuva-A™     (0.025% tretinoin) and Redermic in combination with Rejuva-A™ (0.025% tretinoin).   "
238845|NCT00974493|"     The study will compare the outcomes of treating bone and joint infections with 6 weeks of     intravenous antibiotics with 6 weeks of oral antibiotic treatment. The trial is of antibiotic     strategy rather than of individual antibiotics. The study will be open label, but the     primary outcome will be proven failure of infection treatment, determined by pre-established     objective criteria for treatment failure. The null hypothesis tested is that there will be no     difference in treatment failure rates.   "
238846|NCT00974506|"     In a randomized controlled pilot study the investigators include geriatric patients living in     a geriatric residential community. Two interventions are compared:        1. a complex intervention containing exercise therapy, nutritional advice, homeopathy and          naturopathy in addition to routine therapy by the general practitioner        2. routine care by general practitioner      The investigators assess the effect of the complex intervention on activities of daily living     (AMPS, Barthel Index, Nosger), quality of life (Qualidem, Profile of Wellbeing), risk of     falls (Tinetti), falls, cognition (Minimental Status Test), hospital admissions, medication     use.      The results of this exploratory study are needed to plan a randomized controlled trial (RCT)     with confirmatory design in the future.   "
238847|NCT00974519|"     Immunity 1 (Fuzheng 1) is composed of herbs which have tonic and detoxific function. The     long-term clinical application has proved the safety and effect. It can improve the symptoms     and signs in AIDS patients with the effective rate of 70% and can significantly improve the     quality of life. It can also improve and stabilize immune function and inhibit viral     replication. The basis study have shown that Immunity 1 (Fuzheng 1) can inhibit viral     replication from multi-target, multi-link, enhance immune function, increase the secretion of     IL-2, IFN-γ, participate in immune regulation effect, enhance NK cell activity, promote     CD3+CD4+T cell proliferation and increase macrophage phagocytes capacity.   "
238848|NCT00974532|"     Subjects with normal kidney function are able to excrete in their urine the calcium and     phosphorus absorbed via the gastrointestinal tract and are thereby are able to maintain     calcium and phosphorus balance. Patients with chronic kidney disease often have normal blood     levels of calcium and phosphorus but no research has been conducted to determine if they are     able to excrete their daily intake of these minerals. If they are not able to excrete their     daily intake, these minerals could be deposited in soft tissue and blood vessels and     contribute to the increased risk of cardiovascular disease seen in patients with chronic     kidney disease. This study will determine if subjects with chronic kidney disease are in     balance primarily with regard to calcium and at what level of kidney function they are no     longer able to maintain balance. Understanding whether patients with chronic kidney disease     are in balance will help direct future therapeutic interventions.   "
238849|NCT00974558|"     The aim of the study is to investigate if the use of a handheld fan directed to the cheeks     alongside conventional medical treatment partially or totally relieves breathlessness and if     this effect lasts for at least 30 minutes in patients irrespective of the underlying disease     process.   "
238850|NCT00974571|"     This study will assess the ability of montelukast to improve the signs and symptoms of     perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an     active control.   "
238851|NCT00974584|"     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,     tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered with one of three     planned regimens: Arm A: paclitaxel and carboplatin in bevacizumab-ineligible NSCLC patients,     Arm B: paclitaxel, carboplatin, and bevacizumab in bevacizumab-eligible NSCLC patients and     Arm C: pemetrexed, cisplatin, and bevacizumab in bevacizumab-eligible, non-squamous NSCLC     patients.   "
238852|NCT00974597|"     The purpose of this study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of     donor sites in burn surgery.   "
238853|NCT00974610|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in peptides and proteins and identify biomarkers     related to cancer.      PURPOSE: This research study is looking at blood samples from patients with malignant     melanoma, metastatic breast cancer, advanced lung cancer, pancreatic cancer, or colorectal     cancer.   "
238854|NCT00974623|"     A multi-center, prospective, observational patient registry to collect information on the     clinical outcomes and real world use of approved and commercially available bone graft     substitutes, autograft and allograft.   "
238855|NCT00974636|"     ABSTRACT      Background:      It is well recognized that excess dietary salt intake plays a major role in the development     of hypertension. Chronic Kidney Disease (CKD) is associated with excess salt and water     retention (excess volume) which is associated with hypertension.      Hypotheses:      Hypothesis 1:      Dietary salt restriction will improve volume status in subjects with CKD stages 3-4 as     assessed by Bioelectrical Impedance Analysis (BIA).      Hypothesis 2:      Dietary salt restriction will result in improved blood pressure control in patients with CKD     stages 3-4.      Hypothesis 3:      Dietary salt restriction will decrease albuminuria in patients with CKD stages 3-4.      Patients and Trial Design: This randomized crossover pilot study is designed to assess the     effect of salt restriction on volume status in patients with CKD stages 3 and 4.      Subjects will be randomized to a treatment order: (1) 4 weeks of salt restriction of <85 mmol     sodium per day, a 2 week washout period, and 4 weeks of usual salt diet, OR (2) 4 weeks of     usual diet, 2 weeks washout, and 4 weeks of salt restriction. Patients will receive dietary     counseling in person at each study visit and at weekly intervals by phone calls from study     dieticians. At weeks 0, 4, 6 and 10, patients will undergo assessments for (i) physical     examination with assessments for weight, blood pressure, pulse, anthropometrics and a     standardized clinical assessment of volume status. (ii) volume status using bioelectrical     impedance analysis (BIA) (iii) 24-hour urine testing for, albumin, creatinine and aldosterone     Every 2 weeks throughout the study, a 24-hour urine sodium will be measured for compliance,     and serum electrolytes will be assessed for safety.      Data Analysis: BIA measurements in the low salt group will be compared with the regular diet     group using the standard linear model analysis for 2x2 crossover trials. Additionally,     24-hour ambulatory and static blood pressure and 24-hour urine aldosterone levels will be     compared between the two groups.      Future Implications: A significant reduction in the degree of volume expansion (as assessed     by BIA) and blood pressure as a result of a salt restricted diet would have implications for     renal and cardiovascular protection and would warrant confirmation by a larger randomized     trial.   "
238856|NCT00974649|"     The current study aims to explore and analyse the decision making process of couples in     regards to continuing or discontinuing infertility treatment. A longitudinal, prospective     cohort design is used which allows the monitoring of patients over a longer period of time.     Data will be collected quantitatively (questionnaires) as well as qualitatively (in-depth     interviews) to allow for a more specific and in depth experience than can be obtained by     using a questionnaire study. Innovative aspects of the study include:        1. exploration of determinants of continuing and discontinuing infertility treatment by          using a comprehensive psychological theory (both surface and in-depth)        2. exploration of gender differences in the decision making process in continuing or          discontinuing treatment        3. longitudinal and prospective arm of the study will allow to gain insight into the          'process'        4. prediction of continuing/discontinuing treatment based on psychological variables.   "
238857|NCT00974662|"     The aim of this study is to determine the dose of WST11 and light energy necessary to obtain     desobstruction of the bronchial lumen using Vascular Targeted Photodynamic therapy in     obstructive Non-Small Cell Lung Cancer.   "
238858|NCT00974675|"     The study includes participants with moderate asthma who were randomly assigned to receive     the study medication (CAT-354) or placebo.   "
238859|NCT00974688|"     Quality of life and heart health are intimately connected to childhood physical activity     participation (PAP). Physical activity is critical to childhood growth, development,     learning, socialization, and quality of life and is an essential component of life-long heart     health. Research by the investigators of this study and others has shown that low PAP levels     are common among children with heart defects, and that these sedentary lifestyles are not     related to exercise capacity, medical status or heart function.   "
238860|NCT00974701|"     This study is aimed at assessing the capability of the PillCam Platform using the PillCam ESO     2 Capsule in:        -  Determining whether there is 1) active bleeding in the Upper gastrointestinal (UGI)          tract, 2) identifying the anatomic location of acute overt UGI bleeding, and 3)          discriminating a variceal versus non-variceal source of UGI bleeding.   "
238861|NCT00974714|"     The purpose of this study is to evaluate the effects of oral L-arginine administration on     pregnant women at second trimester of gestation with chronic hypertension, respect with     placebo.   "
238862|NCT00974727|"     The purpose of this study is to examine the impact of a summer gardening program on summer     weight gain in overweight middle school children.   "
238863|NCT00974740|"     Clinical studies have shown that immunomodulators (like Anti-CD3 antibodies) have effects on     beta-cell-preservation. The lipid-lowering agent atorvastatin is also a potent     immunomodulator. In this study the effects of 80 mg atorvastatin per day on preservation of     beta-cell function in recent onset type 1 diabetes were studied, as determined by stimulated     C-peptide levels.   "
238864|NCT00974753|"     Evaluate the efficacy of ketorolac 0.5%, a topical non-steroidal anti-inflammatory drug     (NSAID), to prevent macular edema after epiretinal membrane surgery. Patients undergoing     epiretinal membrane surgery have increased risk of macular swelling which can adversely     affect vision. Since post-intraocular surgery inflammation is a contributing factor to     macular swelling and loss of vision, NSAID drops may be able to prevent or minimize the     deleterious effects of macular swelling after epiretinal membrane surgery.   "
238874|NCT00981981|"     The purposes of this study were:        1. To determine if a breakfast cereal containing 3g of high molecular weight oat          beta-glucan fiber would lower low-density lipoprotein (LDL) - cholesterol (the bad          cholesterol) compared to a control cereal containing wheat fiber.        2. To determine if the LDL-cholesterol-lowering effect of oat beta-glucan fiber was reduced          when the molecular weight of the fiber was reduced.   "
239380|NCT00988130|"     RATIONALE: High-intensity focused ultrasound focal ablation uses high-energy sound waves to     kill tumor cells.      PURPOSE: This phase II trial is studying the side effects of high-intensity focused     ultrasound focal ablation and to see how well it works in treating patients with progressive     prostate cancer.   "
238865|NCT00974766|"     Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex     hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. Oral     corticosteroids are currently the treatment of choice for ABPA associated with bronchial     asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory.     However, there is no data to guide the dose and duration of glucocorticoids and different     regimens of glucocorticoids have been used in literature. The disorder is highly prevalent in     India. The investigators have previously reported their experience with screening stable     outpatients with bronchial asthma and acute severe asthma for ABPA. The investigators have     also recently reported the prognostic factors associated with clinical outcomes in patients     with ABPA.      The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and     safety of two different glucocorticoid dose protocols in patients with ABPA.   "
238866|NCT00974779|"     The purpose of this study is to test whether a dialyzer with a higher than usual permeability     for proteins can eliminate proinflammatory proteins from the blood of patients on regular     maintenance hemodialysis who have chronically elevated levels of inflammation markers such as     C-reactive protein (CRP) in their blood.   "
238867|NCT00974792|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,     such as rituximab, can block cancer cell growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cell-killing substances to them. Giving more than one drug (combination chemotherapy)     together with rituximab may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together     with rituximab works in treating patients with diffuse large B-cell non-Hodgkin lymphoma.   "
238868|NCT00974805|"     This study is investigating the possible mechanisms of action of an inhaled treatment     (Seretide), currently used worldwide in millions of patients with COPD (Chronic Obstructive     Pulmonary Disease) and how it improves the symptoms of these patients. Previous research has     failed to identify the mechanisms at play other than dilation of the airways. The research     community has long thought the mechanism to be immune based or anti inflammatory but despite     intensive research this has not yet been identified.   "
238869|NCT00981916|"     The introduction of local anesthetics and other medications into the epidural space is a     principal technique in provision of anesthesia in many procedures. Typically the anesthetist     accesses the epidural space blindly using palpation and visualization of external landmarks     and then uses a needle to get to the epidural space. The investigators propose a prospective     study of use of ultrasound in a large heterogeneous group of surgical candidates to define     the relationship between the actual needle depth (ND) to the epidural space and measured     ultrasound depth (UD). Establishing correctly the depth to the epidural space via ultrasound     is a component of ultrasound imaging that might improve current technique, and might lead to     faster performance of the epidural. Use of ultrasound may also improve the efficacy and     safety of epidural placement.      The null hypothesis of this study is that ultrasound depth is similar to the needle depth in     adult non parturient patients undergoing lumbar and thoracic epidurals. A parturient in this     case is defined as a female currently near or going through labor.   "
238870|NCT00981929|"     The Cytochrome P450 enzymes are responsible for the metabolism of a wide range of drugs and     other xenobiotics. Genetic variants of the encoding P450 genes have shown to influence the     rate of metabolism of many clinically used drugs.      The drugs tramadol, omeprazole, losartan, quinidine and caffeine reflect the activity of     CYP2D6 (tramadol), CYP2C19 (omeprazole), CYP2C9 (losartan), CYP1A2 (caffeine) and CYP3A4/5     (quinidine).      The aim of the study is to investigate if the cocktail of tramadol, omeprazole, losartan and     caffeine can be used to simultaneously determine the activity of CYP2D6, CYP2C19, CYP2C9 and     CYP1A2. Furthermore, will the natural occurring 4-beta-hydroxy-cholesterol in the blood be     measured as a metric for CYP3A4/5.      The study is divided in two. First part will include 12 healthy volunteers and consists of     three arms separated by at least one week. In the first arm 50 mg of tramadol will be     ingested and urine will be collected for 8 hours. In the second arm 20 mg omeprazole, 25 mg     losartan and 200 mg caffeine will be ingested followed by 8 hours urine collection and a     blood sample 4 hours after administration of the drugs. In the last arm 50 mg of tramadol, 20     mg omeprazole, 25 mg losartan and 200 mg caffeine will be ingested followed by 8 hours urine     collection and a blood sample 4 hours after administration of the drugs.      Metabolic ratios will be calculated based on urine and plasma concentrations of the drugs and     the relevant metabolites. Relevant genetic variants of the cytochrome P450 encoding genes     will be determined.      If the metabolic ratios of the drugs are not significantly different between the arms, Second     part of the study will be conducted.      This part is identical with the last arm and will include a maximum of 400 healthy     volunteers: 50 mg of tramadol, 20 mg omeprazole, 25 mg losartan and 200 mg caffeine will be     ingested followed by 8 hours urine collection and a blood sample 4 hours after administration     of the drugs.   "
238871|NCT00981942|"     The investigators will study the effect of imatinib mesylate (Glivec) in treatment of     moderate to severe nephrogenic systemic fibrosis (NSF).      So far there is no evidence of adequately effective treatment options of NSF. Various     treatments have been tried to stop the progressing disease. Corticosteroids, which suppress     the early inflammatory stage of the disease, fail to halt disease progression.      Other immunosuppressive agents, photopheresis, and kidney transplantations are reported to be     partly beneficial to the patients.      It has not been possible to confirm these findings in further studies because in     photopheresis, and kidney transplantation, such effects are generally unreproducible.   "
238872|NCT00981955|"     Although the beneficial effects of caffeine on cognition and mood have been reported in a     number of studies, relatively few studies have looked at the effects of caffeine in     combination with other phytonutrients despite the fact that caffeine is seldom consumed in     isolation. L-theanine is a naturally occurring amino-acid found in tea, and has been used     historically as a relaxing agent (Haskell et al., 2008). Few have assessed the impact of     l-theanine on cognition, but of those that have, the most interesting results were obtained     when l-theanine was assessed in combination with caffeine (Haskell et al., 2008). It remains     unclear what is underlying the reported effects.      Near Infrared Spectroscopy (NIRS) is an emerging neuroimaging technology that is capable of     determining changes in cerebral blood flow (CBF) by measuring the optical properties of     oxygenated and deoxygenated blood (Bunce et al., 2006). No study to date has used NIRS to     assess cerebral blood flow following treatment with either caffeine, l-theanine or a     combination of both. It is anticipated that the proposed study will provide some insight into     the mechanism of the previously observed effects both alone and in combination.      A randomised, double-blind, placebo controlled, balanced crossover design study will assess     the effects of 75mg caffeine, 50mg l-theanine and a 75mg caffeine/50mg l-theanine combination     in 24 young healthy adults (18-35). Cognitive and mood assessments will take place at     baseline and at 30 minutes following treatment whilst cerebral haemodynamics are measured via     the technique of NIRS.   "
238875|NCT00981994|"     Inappropriate use of antibiotics to treat patients with acute bronchitis is a significant     factor contributing to the selection of antimicrobial drug resistant pathogens, which     threaten the effectiveness of available therapies to treat common community-acquired     bacterial infections. A key factor driving overuse of antibiotics is inaccurate estimation of     pneumonia risk among patients with acute cough illnesses. This study will use a cluster     randomized trial design within the Geisinger Health System's integrated clinic network to     measure the efficacy of an algorithm driven clinical decision support tool to safely reduce     the frequency of unnecessary antibiotic prescriptions for adult patients with lower     respiratory tract infections.   "
238876|NCT00982007|"     The main objective of this study is to demonstrate the efficacy and safety of an     investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in     subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to     oral iron.   "
238877|NCT00982020|"     Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years,     with bipolar I disorder (manic or mixed episodes) or schizophrenia.   "
238878|NCT00982033|"     The primary objective of this study is to determine whether treatment with aliskiren (300 mg)     compared to placebo will improve treadmill exercise time in older (age ≥ 55 years) patients     with heart failure and normal ejection fraction (HFNEF).   "
238879|NCT00982046|"     The purpose of this study was to evaluate the clinical performance of three differing contact     lens care solutions when used in conjunction with three contact lenses.   "
238880|NCT00982059|"     The risk of colorectal cancer (CRC) is significant among cancer survivors treated with     abdominal radiation therapy (RT). Further, CRC is once of the few cancers for which there is     effective screening. Although some expert groups recommend early CRC screening for patients     with prior abdominal RT, the effectiveness of early screening is unknown. It is also unknown     if radiation-induced CRC passes through a pre-clinical phase in which precancerous polyps     are detectable and treatable prior to becoming invasive cancers. This study will evaluate     whether screening will detect pre-invasive colorectal polyps among survivors treated with RT.   "
238881|NCT00982072|"     The purpose of this study is to compare the effectiveness of tacrolimus (prograf) versus     prednisolone for the treatment of nephrotic syndrome secondary to minimal change disease.   "
238882|NCT00982085|"     The aim of this study is to evaluate the status of allergic diseases in the Korean military     personnel.   "
238883|NCT00982098|"     Urinary incontinence is a frequent complication after radical prostatectomy. Rehabilitative     treatments are frequently utilized to reduce incontinence. However, their efficacy has not     been completely investigated. In this study the investigators will compare the effect of an     early rehabilitation programme (instruction of the patient, pelvic floor muscle training,     electrical stimulation and biofeedback) versus instruction of the patient only.      The investigators hypothesis is that early rehabilitation programme is more effective than     patient's instruction alone in preventing urinary incontinence after radical prostatectomy.   "
238884|NCT00982111|"     The research study is testing the investigational drug necitumumab in the treatment of     advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab,     given together with a standard chemotherapy combination consisting of cisplatin and     pemetrexed will be more effective in improving participant disease than the standard     chemotherapy combination alone.   "
238885|NCT00982124|"     The investigators have currently finished conducting an international multi-center trial that     compares the efficacy and safety of pamidronate and zoledronate in the treatment of moderate     to severe forms of Osteogenesis Imperfecta (OI). This trial has included only children above     one year of age. The aim of the current study is to extend the observations of that currently     finished study to infants below 1 year of age. Moreover, it is possible to administer     zoledronate in a single short infusion instead of the three-day cycles with Pamidronate,     therefore decreasing patient and family burdens with shorter stays in the hospital.   "
238886|NCT00982137|"     The purpose of this study is to obtain safety, tolerability, and immunogenicity data on the     co-administration or sequential administration of Chimeravax™-JE vaccine and STAMARIL®.      Objectives:      Safety:        -  Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE          administered concurrently, one month before or one month after STAMARIL® to adult          volunteers (≥ 18 to ≤ 55 years) without prior Japanese encephalitis (JE) or yellow fever          (YF) vaccination.      Immunogenicity:        -  Obtain data on the antibody response to a single, fixed dose of ChimeriVax™-JE          administered concurrently, one month before or one month after STAMARIL® to adult          volunteers without prior JE (or YF) vaccination.        -  Assess the durability of the immune response in adult volunteers 6 months after          administration of ChimeriVax™-JE and STAMARIL®.   "
238887|NCT00982150|"     This will be an open label treatment extension phase in patients with ALS who have previously     participated in the double blind, placebo-controlled ALS-TAL-201 study. This study will make     talampanel treatment available to all subjects who completed the double blind     placebo-controlled phase of ALS-TAL-201 study and where the investigator and patient consider     it to be in the patient's interest to receive talampanel 50mg three times daily (tid). It     will also enable the exploration of long-term safety and tolerability of talampanel 50mg tid.   "
238888|NCT00982163|"     The study was designed to evaluate the pattern of seasonal allergic signs and symptoms     consistent with ongoing ocular allergic inflammation during ragweed season. It was     hypothesized that a pattern of ongoing ocular allergic inflammation existed in certain     subjects.   "
238889|NCT00982176|"     The general purpose of the present pathophysiological study is to investigate the relation     between cognitive impairment observed after an acute coronary syndrome and the presence of     cerebral anatomo-functional abnormalities. This study will improve the investigators'     understanding of the disease and will help in early diagnosis and prevention of vascular     dementia in this population.   "
238944|NCT00983515|"     Ritonavir is a potent inhibitor of CYP3A4, one of the enzymes responsible for the metabolism     of colchicine. This study will evaluate the effect of multiple doses of ritonavir on the     pharmacokinetic profile of a single 0.6 mg dose of colchicine. A secondary objective is to     evaluate the safety and tolerability of this regimen in healthy volunteers. All study     subjects will be monitored for adverse events throughout the study period.   "
238890|NCT00982189|"     This study is funded by the American Heart Association. The goal of this research is to     prevent early cardiovascular damage before symptoms develop for persons with HIV infection.     Evidence suggests that taking low doses of blood pressure and cholesterol medication reduces     risk for heart disease in persons who are at increased risk (such as the case with HIV     infection).      Participants who are taking HIV treatment with an 'undetectable' viral load, and who do NOT     need treatment for high blood pressure or cholesterol may be eligible to enroll. Participants     will take a low dose cholesterol medication (or placebo) and a low dose of a blood pressure     medication (or a placebo), and will be seen at 3 study visits over 4 months.   "
238891|NCT00982202|"     This study was designed to assess the safety and tolerability of pioglitazone, an approved     drug for type 2 diabetes, in non diabetic patients with Alzheimer's disease. It was also     designed to generate preliminary information on whether pioglitazone might slow progression     of Alzheimer's disease.   "
238892|NCT00982215|"     Paracetamol is the centrally acting analgesic most commonly used in the world, indicated for     the symptomatic treatment of fever and pain in mild to moderate. It comes in different     formulations for oral, intravenous and rectal. The IV route allows rapid passage of     paracetamol in the systemic arterial circulation and thus the brain, faster distribution     evidenced a higher plasma concentration compared with oral and rectal. However the IV route     also has disadvantages well known risks iatrogenic perfusion is an invasive lengthy,     unpleasant and painful.      The way per-Albus not to date used for the administration of paracetamol. It is a path     nonetheless very interesting for the rapid absorption of drugs such as nitrates used in     angina pectoris, as it seeks a highly vascular area (the floor of the tongue or gingival     groove) and allows a very rapid action. Furthermore, the terminal per-oral mucosa, less     restrictive than IV administration and faster than oral administration, requires a simple     medical gesture without special surveillance after administration, produces no pain or risk     of infection for the patient (in contrast to the IV). It is interesting to test a new dosage     form per-oral mucosa of paracetamol and compare pharmacological level (pharmacokinetics and     pharmacodynamics) with the only dosage form of reference used by the IV route.   "
238893|NCT00982228|"     This trial is conducted in Africa, Europe and the United States of America (USA).      The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue     (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients     with type 1 diabetes.      The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension     period is registered as NN1250-3644.   "
238894|NCT00982241|"     The researchers want to investigate how fluid intake influences the symptoms of OAB. The     researchers will recruit 45 patients with OAB and randomize them (blind) in 3 groups     (low/normal/high fluid intake). Patients will follow this drink pattern for 2-5 days, while     filling in an standard micturation diary for 2 days. This micturation diary is coupled to:     collection of multiple urine samples, urine pH measurements, and a Perception of Intensity of     Urgency Scale (PPIUS) scoring table. All this is collected by the patients themselves. Urine     samples will be analysed for osmolality by the clinical chemistry department.   "
238895|NCT00982878|"     The purpose of this study is to describe the Central Nervous System exposure of maraviroc in     HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at     steady state.   "
238896|NCT00982891|"     Chronic Obstructive Pulmonary Disease (COPD) affects at least 750,000 Canadians and is     currently the 4th leading cause of death in Canada. Almost everyone with COPD suffers from     shortness of breath (dyspnea) that worsens over time despite standard treatment (inhalers,     exercise programs and oxygen). Patients and families have identified relief from dyspnea as a     top priority for improved care. New approaches are needed for treating advanced COPD to     lessen the burden that it places on the lives of patients and families alike. Opioid drugs,     such as morphine, can help in COPD in many ways, including reducing dyspnea, fear and     anxiety. Opioids are used widely in cancer for similar symptoms. However, there are     historical biases against their use in advanced COPD (mostly due to fear of side effects when     much higher doses than the investigators intend have been used in the past). No studies have     assessed the value to patients of using low dose opioids in advanced COPD in addition to     conventional treatment. The investigators are planning a study that involves recording     interviews with about 30 patients and their partner or key family member before and after     starting treatment with low dose morphine, to understand their experiences with using     morphine. The investigators will also ask them to complete questionnaires about quality of     life, dyspnea, anxiety, depression and fear. Descriptions of experiences of using morphine     have the potential to inform patients, families, clinicians and professional societies about     the benefits and harms of opioid use for dyspnea in the advanced stages of a common serious     lung disease when traditional treatments often fail. The investigators will conduct the study     in both urban (Halifax and Saskatoon) and in a rural setting (New Brunswick). The     investigators' study of an inexpensive and widely available treatment has the potential to     improve care and outcomes in advanced COPD for the many Canadians living and dying with this     serious lung disease.   "
238897|NCT00982904|"     This study is aimed at assessing the tolerability and pharmacokinetic parameters of the     fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental     Trypanosomiasis infections, fexinidazole shows highly promising efficacy.   "
238898|NCT00982917|"     Playground injuries are common at childcare centers. Adequate adult supervision is an     important component to reducing playground injuries in preschool children. The investigators     studied the Stamp-in-Safety Program, an intervention to improve adult supervision and reduce     children's risky playground behaviors.   "
238899|NCT00982930|"     This is an open-label, single arm (uncontrolled) study in subjects suffering from cystic     fibrosis, who have completed their study participation in CTBM100C2303 (all visits) and who     were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.   "
238900|NCT00982943|"     During the past decade, the dramatic change in patterns of both psychiatric diagnoses and     prescription of psychotropic agents has been noted since the introduction of newer     antidepressant drugs. In the meantime, suicide has been recognized as a major public health     problem all over the world. Research efforts have hence been spent in exploring the     interrelationships between suicide rates and prescription of antidepressant drugs (as a proxy     for the treatment of depression). However, most available studies came from developed     countries despite that the majority of countries with rising suicide rates during the past     decade were developing countries. Both suicide rates and prescription of antidepressant     agents have been rising in Taiwan during the past decade; with a reliable mortality registrar     and nationwide health insurance covering 99% of its population, Taiwan is distinctive in     realizing a large-scale analysis on these interrelationships between suicide and prescription     of antidepressant drugs. However, there has been no study in Taiwan exploring these potential     associations up to now.      This study aims at examining the interrelationships between suicide rates and prescription of     antidepressant agents based on the health insurance data from persons who had diagnoses of     ICD: 290-319 or were prescribed with antidepressant agents during the period from 1998 to     2006. The investigators plan to first perform correlation analyses between the trends of     suicide rates and prescription of antidepressants during the study period after taking into     accounts potential confounding factors; analyses by age, gender groups and by administrative     regions will also be performed. Besides, the investigators plan to analyze the change in the     prescription pattern of psychotropic agents in Taiwan during the study period, with the     particular focus on that of newer antidepressant drugs. The prescription of psychotropic     agents in both psychiatric and non-psychiatric diagnoses will be explored.   "
238901|NCT00982956|"     Objective:      The purpose of this study is to evaluate the application of computer-assisted navigation in     Total Knee Arthroplasty (TKA ) by comparing it with conventional TKA.      Methods:      Gemini MK II implants (Link, Germany) were used. VectorVisionâ CT-free navigation system     (BrainLab, Germany) was employed for the TKA. For each subject, computer-navigation TKA and     the conventional TKA were separately performed on two knee joints. The operative method and     order of the operations were decided on a randomized basis. All the patients and doctors     conducting follow-up study and performing imaging measurement were blind to selection of the     operation. Student t test was used for statistical analysis.      hypothesis: computer-assisted navigation system can significantly improve the accuracy of     tibial and femoral cuts on coronal and sagittal planes.   "
238902|NCT00982969|"     The investigators will evaluate the usefulness of QuantiFERON-TB Gold in-tube (QFT) in the     diagnosis of active tuberculosis in young adults group, highly clinically suspected     tuberculosis.   "
238903|NCT00982982|"     The study aims to examine the combined effects of delta-9-tetrahydrocannabinol (∆-9-THC or     THC) and iomazenil on thinking, perception, mood, memory, attention, and electrical activity     of the brain (EEG). THC is the active ingredient of marijuana, cannabis, ganja, or pot.     Iomazenil is a drug that works opposite to drugs like valium. The purpose of this study is to     determine whether the administration of iomazenil will alter the effects of THC.   "
238904|NCT00982995|"     The primary objective of this study is to determine the complete response (no vomiting and no     need for other medications to treat nausea) in terminally ill patients suffering from nausea     and/or vomiting, who are treated with palonosetron. Another objective is to determine the     partial response (relief of nausea and vomiting to the extent that the patient wishes to     continue treatment with palonosetron) after being treated with palonosetron. Palonosetron is     currently approved by the FDA to prevent nausea and vomiting associated with chemotherapy.     The investigators are testing this medication to see if it can help to relieve nausea and     vomiting not associated with chemotherapy.   "
238905|NCT00983008|"     This study will test the feasibility and effectiveness of protected time for physicians in     training during 30 hour shifts in a medical intensive care unit. The primary outcome will be     fatigue. Secondary outcomes include the amount slept while on call, depression, and burnout.   "
238906|NCT00983021|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     safety, tolerability, level of drug exposure and effect of NN9068.      The trial participants will be randomised to 4 different treatments in trial, receiving trial     products in a pre-defined order.   "
238907|NCT00983034|"     Membranous nephropathy (MN) may also be secondary to many other diseases (e.g., infections,     drugs, neoplasms and autoimmune diseases). In this study, the presence of Helicobacter Pylori     (H. pylori) antigen was investigated in renal tissue from needle biopsy samples, and the     prevalence of H. pylori infection and the effects of H. pylori eradication on proteinuria     level in patients with MN will be investigated.   "
238908|NCT00983047|"     Nimotuzumab is a humanized monoclonal anti-body targeting the epidermal growth factor     receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different     indications. Nimotuzumab has demonstrated a unique clinical profile, where anti-tumor     activity was observed in absence of severe skin, renal, gastrointestinal mucosa toxicities     commonly associated with EGFR-targeting antibodies. Nimotuzumab has been granted approval for     use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in     many countries. The investigators compared docetaxel plus nimotuzumab with docetaxel alone in     chemotherapy-refractory/resistant patients with advanced EGFR-positive non-small-cell lung     cancer to assess the efficacy and safety.   "
238909|NCT00983060|"     This is a study designed to identify a dose of NIM811 that has a good safety profile, is well     tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral     load reduction compared to SOC alone. This information will be used to support doses selected     for future studies.   "
238910|NCT00983073|"     The main objective of the study is to evaluate the effectiveness, tolerability, and safety of     tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain     due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or     no regular analgesics. This is a clinical effectiveness trial designed to establish a link     between anticipated clinical outcomes and the clinical practice by means of selected measures     of clinical and subject-reported outcome.      The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I     or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride     prolonged release (PR) treatment during defined periods of evaluation.   "
238911|NCT00983086|"     Epidemiological studies have firmly established the health effects of high intakes of fruits     and vegetables and in particular in regards to the prevention of cardiovascular diseases.     Citrus fruits are the most widely consumed throughout the world, mainly as juice. Citrus     fruits are rich in vitamin C but also in various plant micronutrients which are the most     abundant polyphenols. Several in vitro studies and animal models suggest that the polyphenols     of citrus are involved in the protective effects of citrus vis-à-vis the cardiovascular     diseases. However, profits in health associated with taking these polyphenols are unknown and     so far no clinical studies have been conducted to determine the contribution of polyphenols     of citrus in this protection.      The main objectives of this project are (1) to characterize the effects of single dose and     made repeated consumption of orange juice on vascular protection and the immune response and     (2) to assess the specific role of polyphenols present in citrus fruits in this protection.     To do this the investigators will conduct a clinical study, randomized and crossover, among     healthy men 50 to 65 years that are slightly overweight. These volunteers, who continue to     follow their usual diet, should consume daily for 4 weeks (1) orange juice or (2) an     isocaloric control beverage or (3) the same drink spiked with a dose of polyphenols similar     to that given by orange juice.   "
238942|NCT00983489|"     The investigators hypothesize that counseling of mothers will increase exclusive breast     feeding rates at six weeks postnatal age. In developing countries like India,there is     shortage of staff and the number of newborns cared is huge. So counseling of mothers for     breast feeding becomes difficult. In such a situation using audio-visual aids may be a more     practical option to increase breast feeding rates. Therefore the investigators will compare     the use of video demonstration with counseling for exclusive breast feeding.   "
238912|NCT00983099|"     Part 1 (single dose)      Primary parameters        -  Area under the plasma concentration curve from zero to infinity [AUC0-inf] and observed          maximum plasma concentration [Cmax] of Japanese and Caucasian subjects for each dose          group        -  If at least 20% of the Japanese or of the Caucasian subjects have an area under the          plasma concentration curve extrapolation [AUCextrap%] >20% relative to AUC0-inf for one          of the dose groups area under the plasma concentration curve from zero to the last          measurable concentration [AUC0- tz] becomes primary parameter for Japanese and Caucasian          subjects for all of the dose groups. In this case AUC0-tau will become a secondary          parameter      Secondary parameters and derived values from statistical analysis        -  Dose proportionality and linearity in Japanese subjects        -  Ratios (Japanese vs. Caucasian subjects) of AUC0-∞ and Cmax for each dose group        -  Dose normalized AUC [AUC0-inf,norm], dose normalized Cmax [Cmax,norm], AUC0- tz, time of          occurrence of Cmax [tmax], apparent terminal half life [t½], mean residence time [MRT],          apparent (oral) total plasma clearance [CLtot/f], apparent volume of distribution during          the terminal disposition phase [Vz/f], AUCextrap%, apparent terminal disposition rate          constant [λz], weight corrected AUC0-inf, weight corrected AUC0-tz, weight corrected          Cmax, weight corrected CLtot/f, cumulative amount of excreted Neramexane into urine          [Ae0-tz], fraction of orally administrated drug excreted into urine [fe/f], renal          clearance [CLR] and apparent non-renal clearance [CLNR/f]        -  Safety and tolerability      Other parameters        -  Pharmacogenetics        -  Amount of N-OH Neramexane excreted in urine [Ae0-tz] if a validated method will be          available at the time of analysis        -  Metabolite determination (N-OH Neramexane) in plasma and urine, optional (may be          analyzed and evaluated if a validated method will be available at the time of analysis)        -  Endogenous creatinine clearance [CLCR], amount of excreted creatinine into urine per          hour [AeCR,hr]        -  Evaluation of further metabolites will be described in detail in the Statistical          Analysis Plan   "
238913|NCT00983112|"     Knee prothesis surgery is responsible of a risk of thrombosis and hemorrhage. To prevent     thrombosis, patients have systematic anticoagulation after surgery which are responsible of     hemorrhage. A local glue which improve local coagulation and have no impact of thrombosis can     be a solution to limit hemorrhage. The purpose of this trial is to study the impact of a     biological glue administration on the bleeding loss at five days after a total knee     prosthesis surgery operation.   "
238914|NCT00983125|"     In a prospective randomised study involving primiparous women in spontaneous uncomplicated     labour with cervical dilatation < 5 cm, epidural analgesia will be given with an initial     volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual     injections to achieve analgesia, then by a patient-controlled regimen with 5-mL     self-administered boli in addition to a continuous infusion of 5 mL.hr-1. The anaesthetic     solution will be levobupivacaine presented in 100-mL bags from the market (0.0625%), in which     10 mL (50 g) of sufentanil will be added, as well as clonidine (150 µg) in one arm. The final     concentration of clonidine in this arm will be 1.35 mg.mL-1. Parturients and midwifes     assessing pain during labour will be blinded to the design.   "
238915|NCT00983138|"     This non-controlled multicentre phase II study is designed to assess the safety and to     describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase     (rASNase) for first-line treatment of infants (< 1 year of age at diagnosis) with de novo     acute lymphoblastic leukaemia   "
238916|NCT00983151|"     The purpose of this clinical trial is to test an experimental drug therapy called Tramadol     Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) (Tramadol HCl ODT or the study     drug). The subject and his partner are being asked to be in this clinical trial because they     have a condition called premature ejaculation.   "
238917|NCT00983164|"     The objective of the present study is to evaluate the antioxidant status in the blood of HCV     patients treated with pegylated interferon (2a 1.5 ug/kg; 2b 180 ug) combined with ribavirin     (1000 to 1250 mg) before and after supplementation of vitamins E, C and the mineral zinc (800     mg,500 mg and 40 mg; respectively) during six months.   "
238918|NCT00983177|"     Chronic pain due to calcific tendonitis of shoulder is a prevalent condition usually treated     with recurrent courses of NSAIDs, physical therapy or surgical interventions. Colchicine has     been reported to be effective in the acute attack of shoulder tendonitis, however, has never     been examined in controlled study in patients with chronic shoulder pain secondary to     calcific tendonitis. Eighty patients with chronic shoulder pain (at least 3 months duration)     due to calcific tendonitis will be randomized to receive colchicine 0.5 mg twice daily or     placebo (lactose capsules) for 4 months. At the end of this blinded part of the study,     patients who received placebo and did not improve, will be eligible to continue study in the     open mode for additional 4 months with study drug. Efficacy (VAS for shoulder pain, shoulder     range of motion and shoulder pain and disability index) and safety (blood tests) follow-ups     will be scheduled bi-monthly for all patients.   "
238919|NCT00983190|"     Study Purpose      The purpose of the BeneMACS Long-Term LVAD Study is to demonstrate that survival in non     transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium     and the Netherlands are equivalent to or better than published results in the scientific     literature with approved devices. Implants will be performed following the HeartMate II     guidelines.      Characterization of Patient Population The HeartMate II will be implanted as destination     therapy in patients who are not candidates for cardiac transplantation.      Study Design      The study is a prospective, non-randomized, non-blinded multi-center study with historical     control. The study will consist of the assignment of eligible patients to treatment with the     LVAD. The first 10 patients to have the device implanted will be enrolled in the study.      Study End point      Patients enrolled in the study will be followed until end points defined as death, 2-year     support on the HeartMate II, device removal, transplantation, or recovery.      Data Collection and Follow-up      All data will be entered into INTERMACS® through their web-based data entry system. All data     for the BeneMACs study will be held separately from the main INTERMACS database, and used     only for the purpose of the BeneMACs study.      Investigator sites      Cliniques Universitaires St. Luc, Avenue Hippocrates 10, 1200 Brussels, Belgium Leuven     Gasthuisberg University Hospital, Herestraat 49, 3000 Leuven, Belgium   "
238920|NCT00983203|"     The purpose of this study is to describe the acute comfort and haze profile of FID 114657 in     dry eye patients.   "
238921|NCT00983216|"     Ketoconazole is a potent inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the     enzyme systems responsible for the metabolism of colchicine. This study will evaluate the     effect of multiple doses of ketoconazole on the pharmacokinetic profile of a single 0.6 mg     dose of colchicine. A secondary objective is to evaluate the safety and tolerability of this     regimen in healthy volunteers. All study subjects will be monitored for adverse events     throughout the study period.   "
238943|NCT00983502|"     The investigators' long-term goal is to identify, and then provide general practitioners with     evidence-based recommendations for therapeutic interventions for unexplained chronic fatigue     (UCF). The investigators' central hypothesis guiding this application is that some     complimentary and alternative medicine (CAM) practitioners have developed management     approaches that are more helpful to patients with UCF than usual care.   "
238922|NCT00983229|"     Various supraglottic airways may be used as a dedicated airway for insertion of intubating     fibrescope and tracheal intubation in the patients with difficult to manage airways     (Difficult Airway Society Guidelines).      The investigators aim to compare three different types of supraglottic device as a conduit     for tracheal intubation - CTrach optical laryngeal mask, Intubating laryngeal mask airway and     I-gel supraglottic airway. Null hypothesis for this study is that all three devices will     perform without statistical difference in the means of success rate and time needed for their     insertion and tracheal intubation.   "
238923|NCT00983242|"     Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp).     Verapamil hydrochloride is a potent inhibitor of cytochrome P450 (CYP) 3A4 and P-gp. This     study will evaluate the effect of multiple doses of extended-release verapamil hydrochloride     (verapamil HCl ER) on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A     secondary objective is to evaluate the safety and tolerability of this regimen in healthy     volunteers. All study subjects will be monitored for adverse events throughout the study     period.   "
238924|NCT00983255|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     single rising and multiple rising IV doses of TR-701 FA and to determine the absolute     bioavailability of oral TR-701 FA following single oral and IV dose administrations in     healthy adult subjects.   "
238925|NCT00983268|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving capecitabine     and vorinostat together with radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when     given together with capecitabine and radiation therapy in treating patients with     nonmetastatic pancreatic cancer.   "
238926|NCT00983281|"     This is a chart review of all trauma patients during the specified time period. The purpose     of this study is to examine the effects of resuscitation with hextend after trauma, in the     adult population. The authors hypothesize that when compared to patients resuscitated with     standard of care, resuscitation with Hextend will result in a mortality difference.   "
238927|NCT00983294|"     Azithromycin is a possible weak to moderate inhibitor of CYP3A4, one of the enzymes     responsible for the metabolism of colchicine. This study will evaluate the effect of multiple     doses of azithromycin on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A     secondary objective is to evaluate the safety and tolerability of this regimen in healthy     volunteers. All study subjects will be monitored for adverse events throughout the study     period.   "
238928|NCT00983307|"     It is generally accepted that the presence of chronically hypoxic cells, or tumor cells which     do not receive enough oxygen as a result of tumor growth, may be an important cause of     resistance to radiation therapy (RT) and resultant tumor recurrence, particularly in large     tumors such as advanced non-small-cell lung cancer (NSCLC). Therefore, delivering a higher RT     dose, as is done with hypofractionated RT, to the tumor may result in higher success rate.      Erlotinib (Tarceva, previously known as OSI-774) is an orally active, potent, selective     inhibitor of the Epidermal Growth Factor Receptor (EGFR) tyrosine kinase. A recently     completed trial has shown that Erlotinib as a single agent significantly improves the     survival of patients with incurable Stage IIIb/IV NSCLC who have failed standard therapy for     advanced or metastatic disease. Therefore, Erlotinib is an approved medication for     second-line therapy in lung cancer following prior chemotherapy.      This is a Phase II clinical research study to assess the efficacy and toxicity of     hypofractionated radiation therapy in combination with Erlotinib in patients with locally     advanced or inoperable non-small-cell lung cancer (NSCLC).      The investigators' hypothesis is that the addition of erlotinib to RT will result in     radiosensitization, therefore increasing the likelihood of local tumor control over RT alone.     Maintenance erlotinib upon RT completion will result in further tumor growth inhibition, both     systemically and locally, lengthening disease-free survival and overall survival.   "
238929|NCT00983320|"     This is a double-blind, randomized, placebo-controlled trial measuring the impact of     quetiapine on clinical and experimental measures of pain in fibromyalgia and its biochemical     correlates.   "
238930|NCT00983333|"     This research focuses on communication practices between patients and health care     professionals, like nurses, doctors, or physician assistants. The goal is to help improve     communication about heart health issues.      This pilot (or Beta) study is designed to test our ability to recruit an appropriate sample     of participants, and determine our ability to deliver and evaluate the effects of a web-based     intervention. The investigators hypothesize that exposure to the intervention will result in     measurable changes in self-reported knowledge, attitudes and behavior regarding communication     between patients and health care professionals.      Participants in this research study are being recruited from the people who currently receive     care at the Richmond Family Health Center of the Oregon Health & Science University. People     who participate in this study will be between 55 and 70 years old, speak English as their     preferred language, and have one of several possible diagnoses related to heart health. These     could include, for example, hypertension, diabetes, asthma, or obesity.      Additionally, the investigators are recruiting a small number of health care professionals     from the Richmond Family Health Center. Their participation will be similar to but separate     from the participation of patients.      All participants will take two web-based surveys. Some participants will use a web-based tool     that hopes to help improve communication between health care professionals and patients.      The surveys contain questions that explore the knowledge, attitudes, and behaviors of     participants related to heart health and communication between health care professionals and     patients.      Data analysis will focus upon identifying any changes that occurred in knowledge, attitudes,     or behaviors with respect to health communication after using the web-based tool, as well as     learning about what influences the quality and nature of communication between health care     professionals and the patients they serve.   "
238931|NCT00983346|"     OBJECTIVES        -  Primary: To evaluate the bone anabolic effect of bortezomib in patients with smoldering          myeloma.        -  Secondary: To evaluate the effect of bortezomib on the natural history of smoldering          myeloma.   "
238932|NCT00983359|"     RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor     and cause less damage to normal tissue.      PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in     treating patients with brain metastases   "
238933|NCT00983372|"     Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp).     Extended-release diltiazem (diltiazem ER) is a potent inhibitor of both CYP3A4 and P-gp. This     study will evaluate the effect of multiple doses of diltiazem ER on the pharmacokinetic     profile of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the     safety and tolerability of this regimen in healthy volunteers. All study subjects will be     monitored for adverse events throughout the study period.   "
238934|NCT00983385|"     The main objective of the study is to evaluate the effectiveness, tolerability, and safety of     tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back     pain (LBP) who are taking either WHO Step I or Step II analgesics or no regular analgesics.     This is a clinical effectiveness trial designed to establish a link between anticipated     clinical outcomes and the clinical practice by means of selected measures of clinical and     subject-reported outcome.      The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I     or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride     prolonged release (PR) treatment during defined periods of evaluation.   "
238935|NCT00983398|"     This phase I/II trial studies the side effects and best dose of melphalan when given together     with carboplatin, mannitol, and sodium thiosulfate, and to see how well they work in treating     patients with recurrent or progressive central nervous system (CNS) embryonal or germ cell     tumors. Drugs used in chemotherapy, such as melphalan and carboplatin, work in different ways     to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption (BBBD)     uses mannitol to open the blood vessels around the brain and allow cancer-killing substances     to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing     loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving     melphalan together with carboplatin, mannitol, and sodium thiosulfate may be an effective     treatment for recurrent or progressive CNS embryonal or germ cell tumors.   "
238936|NCT00983411|"     The investigators hypothesized that increasing non intentional leaks could increase work of     breathing and could lead to patient/non-invasive ventilation (NIV) asynchrony.      The main objective is to compare ventilatory pattern (work of breathing, flow, pressure)     under NIV with and without non-intentional leaks in 10 awakened healthy subjects and 10     awakened and asleep obese hypoventilation syndrome (OHS) patients.      Methods: While the subjects will be under NIV, several levels of leaks will be simulated in a     random order with an automatically opening valve. Breathing pattern (work of breathing,flow,     pressure, thorax and abdominal movements) will be recorded by Polygraphy. Healthy subjects     will be recorded only during awakened state. OHS patients will be recorded both during awake     and sleep sates.      Analysis: A repeated measures analysis of variance (ANOVA) will compare work of breathing     according to the different levels of leaks.   "
238937|NCT00983424|"     The purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel     and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer cells     as well as or better than nab-paclitaxel alone.   "
238938|NCT00983437|"     The primary objective of this study is to evaluate the safety and tolerability of long-term     (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild     or moderate closed traumatic brain injury (TBI).   "
238939|NCT00983450|"     The study will include 20 subjects who will be randomly divided to two groups: a ten person     group being the study group and a ten person group acting as a control group (each group will     include a similar number of females and males as the other group). In addition, the     physiotherapy treatments at the rehabilitation center, the study group will gain an     intervention consisting of 12 therapy sessions, administered for 12 consecutive days (apart     of weekends). The intervention will include 6 minutes of watching a movie clip alternately     showing a healthy man and a healthy woman at their sixties, walking while being filmed from     various angles. Immediately after watching, the subject will perform 6 minutes of walking,     under the experimenters supervision, but without his or hers intervention. Immediately     following the walking, the whole procedure will be repeated (watching a clip and walking).      The control group will undergo 12 treatments of the same nature, but will watch the movie     clip shown backwards, so that the people filmed will seem to walk backwards (it was     established that watching a reversed action does not activate the MNS system activated by a     regular execution of the activity [Celnik et al., 2008]), followed by 6 minutes of walking     under the experimenters supervision, then watching the movie again and walking again.      The person performing the examinations will be blinded as to the division of the subjects to     the study group and the control group. After performing the previously noted examinations     needed to participate in the research, the subjects found fit will be examined before the     beginning of the intervention, at its end and then three months after its conclusion. The     examinations will include smart step and walking parameters.   "
238940|NCT00983463|"     Nonalcoholic fatty liver disease (NAFLD) is the most common type of liver disease in the     United States. The incidence of NAFLD is very similar to that of obesity, type 2 diabetes,     and the metabolic syndrome. The investigators hypothesize that there may be a relationship     between over-nutrition, decreased physical activity and the development of fatty liver. The     purpose of this study is to identify the types of fats and proteins, and the quantity of     each, that are associated with increased severity of NAFLD.   "
238941|NCT00983476|"     Obesity and physical inactivity have reached epidemic proportions, resulting in increased     rates of a variety of chronic diseases, increased risk of death, and substantial health care     costs. Individuals with serious mental illness are even more likely to be overweight or     obese, which contributes to the high rate of co-morbid medical disease and early mortality     found among this population. Specific individual and group-based psychoeducational     interventions have repeatedly and consistently been shown to help adults with serious mental     illness improve their weight. However, these require substantial time from mental health     clinicians, and frequent visits by patients to mental health clinics. This creates challenges     for patients who may need to travel to a medical center that provides these services, and who     often have limited transportation options. It is likely that these barriers can be addressed     with a computerized, web-based intervention focused on diet and exercise education, and     tailored for veterans with serious mental illness. Web-based systems can deliver content that     is intensive, engaging, and tailored to the needs and preferences of specific patients.     Web-based systems can be delivered using computers at community-based outpatient Clinics or     other settings in the community. The objective of this project is to develop and evaluate the     effectiveness of a web-based intervention to help patients with serious mental illness lose     weight.   "
239027|NCT00984594|"     The objective of this study is to determine how effective a plug made out of human bone     (called CR-Plug) will be in the treatment of smaller, focal defects (like the injury the     patient has to their knee).   "
238945|NCT00983528|"     Clofarabine is approved by the FDA for the treatment of pediatric patients (1 to 21 years of     age) with relapsed or refractory ALL. Alemtuzumab is approved by the FDA for treatment of     B-cell chronic lymphocytic leukemia (B-CLL) in patients over the age of 18. These drugs have     been used to treat patients with leukemia in other research studies like this one. Both drugs     have individually been administered to adult patients with ALL with acceptable toxicity     profiles. This study will evaluate the combination of clofarabine and alemtuzumab when     administered to adult patients with relapsed or refractory ALL. Primary objectives of the     study is to determine the maximum tolerated dose of clofarabine when administered with     alemtuzumab, evaluate the safety of the combination, and assess for activity of the     combination by evaluating response rate, effect on ALL progenitor cell population, and     patients who are able to bridge to transplant.   "
238946|NCT00983541|"     OBJECTIVES: This study proposes to evaluate the feasibility of delivery of this treatment in     terms of toxicity. If toxicity is not acceptable, the treatment is not feasible.      Primary Objectives        -  To establish a preliminary assessment whether toxicity rates are acceptable in patients          with locally advanced intra or extrahepatic cholangiocarcinoma when treated with a          regimen of gemcitabine every two weeks and continuous fluorouracil (5-FU) given          concurrently with external beam radiation therapy to a total dose of 45 gray(Gy),          followed by a brachytherapy or Stereotactic Body Radiation Therapy(SBRT) boost.      Secondary Objectives        -  To evaluate the overall survival rate, progression free survival rate, tumor response          rate, local control rate and the rate of distant metastases following gemcitabine and          continuous 5-FU concurrent with radiation therapy in patients with locally advanced          intra or extrahepatic cholangiocarcinoma.        -  To evaluate the rate at which patients with unresectable extrahepatic cholangiocarcinoma          become resectable following gemcitabine and radiation therapy.   "
238947|NCT00983554|"     Subjects will be randomized into 4 study groups: 1. Placebo; 2. Anastrazole and Testosterone;     3. Dutasteride and Testosterone; and 4. Testosterone only. A 2 step euglycemic clamp, body     composition by dual X-ray absorptiometry scan, hormone and lipid assays will be performed to     monitor metabolic effects of each treatment group. We hypothesize that increasing     testosterone levels would increase lean mass, decrease fat mass and improve insulin     sensitivity. We further hypothesize that improvements in the metabolic profile would decrease     with anastrazole and improve with dutasteride, given in conjunction with T administration.   "
238948|NCT00983567|"     This study will test a website for teens designed to help them improve both diet and physical     activity. The website will have several components: educational messages, role model stories,     goal setting, self-monitoring forms, problem solving, a monitored discussion forum, and diet     and physical activity (PA) assessment questionnaires.   "
238949|NCT00983580|"     This phase II trial is studying how well giving acetylsalicylic acid together with     eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention     is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and     eflornithine may prevent colorectal cancer.   "
238950|NCT00983593|"     The focus of the present study is to examine the relative efficacy of a mind-body method,     know as Mind-Body Bridging, of treating DV offenders as compared to a treatment as usual     (TAU) approach. The study will be conducted on-site at ACES, a non-profit agency that     provides licensed domestic violence offender and substance abuse treatment services in the     Salt Lake City area.   "
238951|NCT00983606|"     The primary objective is to assess the burden of respiratory disease in outpatient settings     among 32 to 35 weeks' gestational age (wGA) infants in the USA who did not receive RSV     prophylaxis during the infants' first RSV season.   "
238952|NCT00983619|"     The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551)     in subjects with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose     (MTD), or if not reached, at optimal biologic dose (OBD).   "
238953|NCT00983632|"     The investigators would like to explore possibilities of selective vagus nerve stimulation in     human subjects to control heart rate and arterial blood pressure.   "
238954|NCT00983645|"     This study aims to compare outcomes in renal transplant recipients in the hispanic population     based on their immunosuppressant regimens.   "
238955|NCT00983658|"     This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed     to evaluate the efficacy, safety, and tolerability of huMAb OX40L administered to patients by     IV infusion for the treatment of allergen-induced asthma.   "
238956|NCT00983671|"     Background: in various pediatric pulmonary diseases such as asthma, cystic fibrosis or     bronchopulmonary dysplasia an increased inflammation is present. Measuring this inflammation     is often hardly possible and requires invasive techniques such as bronchoscopy.      With the use of exhaled breath condensate (EBC) or exhaled breath (EB) analysis it is     possible to measure the inflammation in an non-invasive way. However, there is a great need     to further standardise these measurements and to identify possible confounding factors.   "
238957|NCT00983684|"     The purpose of this study is to evaluate whether a single fraction of radiotherapy given     intra-operatively and targeted to the tissues at the highest risk of local recurrence is     equivalent to standard post-operative external beam radiotherapy after breast conserving     surgery in women with early stage breast cancer in terms of local relapse within the treated     breast.   "
238958|NCT00983697|"     RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET/CT scan, may help doctors     find head and neck cancer and find out how far the disease has spread. It may also help     doctors plan the best treatment.      PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well     it works in assessing the tumor and planning neck surgery in patients with newly diagnosed     head and neck cancer.   "
238959|NCT00983710|"     This study will compare a newly-developed patient education program to help men with     localized prostate cancer manage treatment-related side-effects versus usual care. The new     intervention will be developed for men with lower health literacy. That means that the     education materials will be developed for sixth grade reading level or lower. The materials     will include lots of examples and illustrations to make it easier for people understand the     information.   "
239066|NCT00985101|"     The purpose of this study is to examine if an early detectable dysfunction in a cellular     component (mitochondria) may predict complications in diabetes mellitus.   "
238960|NCT00983723|"     The study of plasma and urine proteomic profiles in patients with ischemic brain injury is     important to better understanding of the mechanisms by which thrombolytic agents or other     therapy affects clinical outcomes. The purpose of this study is to study the proteomic     profile of patients with ischemic brain injury and compare it to control subjects without     ischemic brain injury, subjects with other chronic neurologic diseases or systemic vascular     diseases, and pre- and post- therapy which may be associated with, or predictive of,     therapeutic outcome.      The investigators hypothesize that there is a unique set of proteins expressed in serum and     urine in patients with ischemic brain injury that may provide a more complete understanding     of ischemic brain injury pathophysiology.      Ultimately, this study may provide information of direct relevance to the medical care of a     large proportion of patients with ischemic brain injury and other neurologic diseases in the     future. And proteomic proteomic profile may provide important information about the roles of     specific biomarkers. Perhaps the prevention of ischemic injury related complications.   "
238961|NCT00983736|"     The purpose of this clinical trial is to test an experimental drug therapy called Tramadol     Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) (Tramadol HCl ODT or the study     drug). The patient and the patient's partner are being asked to be in this clinical trial     because they have a condition called Premature Ejaculation.   "
238962|NCT00983749|"     The purpose of this study is to determine if external counterpulsation (ECP) is feasible to     perform, tolerable, and safe as a treatment for patients with acute ischemic stroke (i.e., a     blockage of one of the arteries supplying a part of the brain), and to assess what type of     effect it might have on 1) the velocity of blood flow in the arteries supplying the brain and     2) stroke symptoms. The hypothesis of the study is that ECP will be feasible and safe to     perform, and will be tolerable for patients with acute ischemic stroke at pressures that     increase the velocity of arterial blood flow to the brain.   "
238963|NCT00983762|"     A functional outcomes comparison study of three surgical techniques using minimally invasive     surgery mini-incision (MIS) for total knee arthroplasty (TKA), standard para-patellar TKA and     the unicompartmental knee arthroplasty performed over a 2+ year post-op period.   "
238964|NCT00983775|"     The purpose of this study is to compare the pharmacological profile of insulin administered     with jet-injection with that of insulin injected with a conventional insulin pen.   "
238965|NCT00983788|"     The investigators propose to evaluate the effect of bezafibrate on metabolism during exercise     in 22 adult patients affected with carnitine palmitoyltransferase II (CPTII) or very-long     chain acyl-CoA-dehydrogenase (VLCAD) deficiencies. This study will be an 9-month, randomized,     double-blind, placebo-controlled crossover trial. The trial will be conducted in two centers:     Institut de Myologie, Pitié-Salpêtrière Hospital in France, and Rigshospitalet, University of     Copenhagen, in Denmark. The main criteria for assessing the potential effect of this drug     will be the fat oxidation rate studied during a moderate workload on cycle ergometer, after     infusion of stable isotopes (palmitate and glucose tracers).   "
238966|NCT00983801|"     The purpose of this study was to determine whether ixabepilone is effective in the treatment     of unresectable or metastatic gastric cancer in Asian participants.   "
238967|NCT00983814|"     Attention Deficit Hyperactivity Disorder (ADHD) is a neurobiological disorder characterized     by lifelong issues of inattention, distraction, organizational difficulties, forgetfulness,     restlessness, talking out of turn, difficulty waiting and interrupting others. ADHD is the     second most common neuropsychiatric disorder affecting 4.4% of the US adult population, or     between 8-9 million individuals (Kessler et al., 2006).      Droxidopa (L-dihydroxyphenylserine (L-DOPS)) is a synthetic catecholamine which is converted     to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE centrally in     the CNS and peripherally. Co-treatment with carboxylase inhibitors, such as carbidopa, given     with droxidopa, can increase the CNS levels of NE with greater crossing of the blood-brain     barrier. Droxidopa has received orphan drug approval by the FDA for the treatment of     symptomatic neurogenic orthostatic hypotension in individuals with primary autonomic failure.     The half-life of droxidopa is approximately 2-3 hours, resulting in administration thee times     daily.      As adult ADHD is characterized as a disorder of decreased NE activity in the pre-frontal     cortex, it is hypothesized that treating patients with droxidopa (in co-administration of     carbidopa) will have a positive effect on adult ADHD.   "
238968|NCT00983827|"     This study aims to determine if Aquatic Treadmill Therapy is effective for improving economy     of gait, gait speed, balance, and cardiovascular fitness in people with chronic stroke.   "
238969|NCT00983840|"     Poor diets lead to weight problems, and may increase cancer risk. Cancers may develop over a     long period of time, with some possibly initiating in childhood. Therefore, promoting healthy     diets and preventing excess weight gain during childhood could be cancer protective. Families     influence children's dietary behaviors by their actions and controlling the home food     environment. The internet provides family access to interventions with the convenience of the     home. An eight-session interactive web-based program promoting a healthy home food     environment for African-American families with 9-12 year old daughters (Family Eats) was     previously developed and tested. This study tests whether the Family Eats web program     improves diet and weight outcomes among 320 African-American families with 8-12 year old     children. This important study will pioneer a new channel for behavior change intervention     with African-American families and holds the promise of reaching large numbers of children     and their families, enabling all to adopt healthy eating behaviors and achieve energy balance     and reduce cancer risks.   "
238970|NCT00983853|"     The purpose of this study is to determine whether the combination of telaprevir,     peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus     (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus     (HIV).   "
238971|NCT00983866|"     The goal of this study is to determine whether having a telephone discussion with a nurse     educator about making treatment decisions and participating in a clinical trial increases     trial participation.      The investigators hypothesize that the participants in the intervention group will be more     likely to take part in a clinical trial than those in the usual care group.   "
239428|NCT00982384|"     The purpose of this study is to determine whether comprehensive disease management program     combined with best care recommended in clinical guidelines, is more effective than best care     alone in patients with advanced chronic obstructive pulmonary disease (COPD).   "
238973|NCT00983892|"     Given the growing strain on the Veterans Administration resulting from increasing caseloads     of cancer patients, interventions are badly needed that assist patients in managing their     illness, improve quality of life and avoid acute episodes that result in urgent care use and     increased mortality. Previous studies have found that cancer patients undergoing chemotherapy     can effectively manage their own symptoms when monitored using automated telephone calls.     Such technology, however, may challenge the number of Veterans who lack social support and/or     independence. The goal was to develop and test a technology that not only monitors patients     automatically by telephone, but also gives them self management advice and engages a friend     or family member to serve as a CarePartner willing to play a limited role in identifying     patient symptoms and psychosocial needs to reinforce self management and provide social     support. The investigators found that this technology indeed helped patients better control     their symptoms, especially when a caregiver participated in the program along with them.   "
238974|NCT00983905|"     Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe     substrate. When the two are co-administered the potential exists for a clinically significant     drug interaction. This study aims to determine the effect of steady-state colchicine on the     pharmacokinetics of theophylline administered as a single dose. A secondary goal is to     evaluate the safety and tolerability of this regimen in healthy volunteers. All study     subjects will be monitored for adverse events throughout the entire study period.   "
238975|NCT00983918|"     To the investigators' knowledge, no study has looked at differences in postoperative pain     when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and     propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total     intravenous anesthesia with propofol will lead to less postoperative pain in the first 24     hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with     isoflurane, desflurane or sevoflurane.      PURPOSE      To find out if maintenance of anesthesia with propofol leads to less postoperative pain after     laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane,     desflurane, or sevoflurane.   "
238976|NCT00983931|"     Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp).     Cyclosporine is a potent inhibitor of both CYP3A4 and P-gp. This study will evaluate the     effect of single-dose cyclosporine on the pharmacokinetic profile of a single 0.6 mg dose of     colchicine. A secondary objective is to evaluate the safety and tolerability of this regimen     in healthy volunteers. All study subjects will be monitored for adverse events throughout the     study period   "
238977|NCT00983944|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving rituximab together with combination chemotherapy may kill more     cancer cells. It is not yet known which combination chemotherapy regimen is more effective     when given with rituximab in treating large B-cell lymphoma.      PURPOSE: This randomized phase II trial is studying how well rituximab and combination     chemotherapy work when given with or without bleomycin sulfate in treating patients with     primary mediastinal large B-cell lymphoma.   "
238978|NCT00983957|"     The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of     Ortho Tri-Cyclen® in healthy female subjects.   "
238979|NCT00983970|"     Exercise is an important component in the treatment of of child obesity and associated     medical conditions. However, one of the strongest predictors of non-compliance from exercise     programs in obese youth is lack of enjoyment, thus creating a more pleasurable environment,     by using TV or video games as incentives, may be an effective way of increasing exercise in     obese youth. The purpose of this study was to compare interactive video game stationary     cycling (GameBike ®) with cycling to music on aerobic fitness, body composition,     cardiovascular disease risk markers, and exercise behaviour as measured by attendance, energy     expenditure, duration, intensity and distance pedaled in obese adolescents. Twenty six obese     adolescents had an equal chance of being assigned to either interactive video game cycling     (n=13) or cycling to music serving as controls (n=13). The 10-week program consisted of twice     weekly sessions lasting a maximum of 60 minutes per session.   "
238980|NCT00983983|"     The purpose of this study is to determine the safety, tolerability, and preliminary efficacy     of long-term use of high fat/high calorie and high calorie diets in people with amyotrophic     lateral sclerosis (ALS) (Lou Gehrig's disease).   "
238981|NCT00983996|"     The objective of this study is to investigate the bioequivalence of Mylan's alendronate     sodium 10 mg tablets to Merck's Fosamax 10 mg tablets following a single, oral 40 mg (4 x 10     mg) dose administration under fasting conditions.   "
238982|NCT00984009|"     Grapefruit juice is an inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the     enzyme systems responsible for the metabolism of colchicine. This study will evaluate the     effect of multiple daily consumptions of grapefruit juice on the pharmacokinetic profile of a     single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and     tolerability of this regimen in healthy volunteers. All study subjects will be monitored for     adverse events throughout the study period.   "
238983|NCT00984022|"     This study compares Aquacel against routine Iodoform packing for packing abscess cavities     after incision and drainage. It is hypothesized that Aquacel will produce speedier healing of     the abscess.   "
238984|NCT00984035|"     The purpose of this study is to identify novel biomarkers of kidney injury in patients     receiving cisplatin.      This study will also collect DNA for future analysis.   "
238985|NCT00984048|"     This is a multicenter translational study to understand therapeutic resistance in patients     undergoing first-line chemotherapy (FOLFOX/Avastin, or FOLFIRI/Avastin) for metastatic     colorectal cancer. Tissue samples from liver metastasis will be collected and banked before     the start of chemotherapy and at the time of progression. Additionally, blood samples will be     drawn monthly and stored in the tissue biobank.   "
239244|NCT00986297|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This phase I trial is studying the side effects and best dose of specialized     radiation therapy in treating patients with stage II, stage III, stage IV, or recurrent     non-small cell lung cancer and poor performance status.   "
238986|NCT00984061|"     Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and     P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is     responsible for the efflux of colchicine across membranes. This study will evaluate the     effect of clarithromycin-related inhibition of CYP 3A4 and P-gp on the pharmacokinetics of     colchicine. It will also evaluate the safety and tolerability of concurrent administration of     clarithromycin and a single dose of colchicine.   "
238987|NCT00984074|"     RATIONALE: Diagnostic procedures, such as specialized types of magnetic resonance imaging     (MRI), may help in planning radiation therapy that does less damage to normal tissues.      PURPOSE: This phase I trial is studying using functional MRI to see how well it works in     planning radiation therapy in patients undergoing radiation therapy to the base of the skull     and/or brain for nonmetastatic head and neck cancer.   "
238988|NCT00984087|"     rTMS is a promising, though largely untested, option for treating adolescent and young adult     depression. This study hypothesizes that rTMS will safely and significantly alleviate     depression and decrease suicidal ideation in adolescents and young adults based on previous     studies.   "
238989|NCT00984100|"     Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of     investigational surgery which uses the endoscope as the primary operative tool. The insertion     sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra.     Multidisciplinary teams of surgeons and gastroenterologists collaborate to develop safe and     effective surgical techniques via the natural orifice route in order to avoid surgical     incisions. Early studies have focused on transvaginal surgery as the access route to the     abdomen as it sidesteps troubling questions about infection and closure of the organ. This     study is a pilot study to test the feasibility to NOTES transvaginal cholecystectomy using     conventional surgical and endoscopic tools.   "
238990|NCT00984113|"     The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its     metabolite in patients with mild, moderate, and severe renal impairment compared to healthy     volunteers.   "
238991|NCT00984126|"     This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.      The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in     Haemophilia A patients.      The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and     NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600     (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September     2011) and NN7008-4015 (start: August 2012, stop: March 2013).   "
238992|NCT00984139|"     This phase IV open study will evaluate the persistence of humoral antibodies against     hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in     adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals'     recombinant hepatitis B vaccine (Engerix™-B) in infancy.   "
238993|NCT00984152|"     Raltegravir not only has a unique mechanism of action, but may also have other unique effects     on suppression of viral replication, viral reservoir, and immune reconstitution in blood and     other important compartments. This may in part be due to the pharmacokinetics of Raltegravir     in blood and gut tissue. Efavirenz will be the comparator antiretroviral drug in this study,     with both drugs being used as part of a three-drug regimen with tenofovir and emtricitabine.      The primary objectives are to determine differences in the effects of 2 anti-retroviral     regimens, Raltegravir + Truvada versus Atripla, with respect to:        1. Viral load in plasma, genital tract (vaginal secretions), and gut (by in situ          hybridization).        2. Latent viral reservoir (pro-viral DNA) in the peripheral blood and genital tract.        3. Immune effects (CD4/CD8 immunophenotypes) in gut and PBMCs and plasma cytokine profiles.      The secondary objective is to determine the pharmacokinetics of Raltegravir in blood and gut     tissue; relative tissue/compartment penetration compared to Efavirenz.   "
238994|NCT00984165|"     Background:        -  Allogeneic hematopoietic stem cell transplantation (allotransplant) has been used to          treat many kinds of cancer that develop in cells from the blood or immune system. After          allotransplant, donor cells take over production of the recipient s blood and immune          cells, and donor immune cells can directly attack and control tumor. However, for          cancers that do not respond to allotransplant, there are no proven cures.        -  A single treatment with radiation can improve the potency of immune-cell therapies. This          is probably because the tumor tissue is damaged in a way that new tumor proteins are          exposed, attracting immune cells to the tumor. By giving only a single dose of          radiation, the immune cells that are attracted to the tumor are allowed to survive and          function in their usual way, traveling throughout the body and educating other immune          cells to recognize tumor, and to activate and expand in order to kill the tumor cells.          Some research has shown that radiation may have a widespread effect on stimulating the          immune system, educating immune cells to recognize and control tumors that have not been          radiated.      Objectives:      - To determine whether a single treatment of radiation will help donor immune cells control     cancer after allotransplant without causing excessive side effects.      Eligibility:        -  Recipients: Individuals 18 years of age and older who have blood cancers that have not          responded to allotransplant.        -  Donors: Healthy individuals 18 years of age and older who were previous allotransplant          donors for one of the study recipients.      Design:        -  Donors will provide additional blood immune cells, called lymphocytes, through          apheresis. Apheresis involves drawing blood, separating out the lymphocytes, and          returning the rest of the blood to the donor.        -  Recipients will receive a single dose of radiation to the greatest amount of tumor that          can be irradiated safely. Researchers will intentionally leave some tumor that will not          be radiated in order to evaluate whether there is a widespread response to the          treatment.        -  There are two treatment arms on the study.        -  Arm 1: Study participants who have donor lymphocytes available and who have not had          major complications from the allotransplant will be given a dose of donor cells after          they receive radiation, to provide an additional boost to the donor immune response.        -  Arm 2: Study participants who cannot receive donor lymphocytes because their donor is          not available, they received an allotransplant from a partially matched relative, or          they have had significant complications from the allotransplant - will receive radiation          without additional donor lymphocytes.        -  All recipients will be followed closely for side effects and for tumor response to          radiation with or without donor lymphocytes. Additional tests will be performed,          including tumor biopsies, bone marrow samples, and blood draws, in order to study the          immune effects of radiation and donor lymphocytes.        -  A separate, control group of allotransplant recipients will not receive radiation. This          group will include participants whose transplant doctors plan to use donor lymphocyte          therapy alone to control cancer progression. This group will donate blood immune cells          through blood draws and apheresis. These cells will be examined to study the immune          effects of receiving donor lymphocytes without radiation.   "
238995|NCT00984178|"     The aim of this study is to compare the effectiveness of four different strategies for     preventing the ventricular postinfarction remodelling: 1) Conventional treatment for     reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells     intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by     granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells     transplantation plus mobilization with G-CSF).   "
238996|NCT00984191|"     The purpose of this trial is to see if the 99mTechnetium-MIBI SPECT-CT can be a tool for     preoperative evaluation of cervical node metastasis in papillary thyroid cancer.   "
238997|NCT00984204|"     The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo     cardiac ablation system can eliminate typical atrial flutter and that its use does not result     in an unacceptable risk of serious adverse events (SAE's).   "
240039|NCT00990392|"     The purpose of the study is to determine if the overall central venous catheter related     infection rate can be reduced by the application of Polysporin Triple Therapy ointment to the     insertion site.   "
238998|NCT00984217|"     Standard therapy for high-risk or locally advanced salivary gland malignancies is surgery     followed by postoperative radiation therapy. Retrospective studies have shown the superiority     of combined modality therapy compared to surgery alone for patients with advanced T or N     stage. Despite the addition of postoperative radiation therapy, the five-year survival for     locally advanced salivary gland malignancies is poor (less than 60%). In salivary gland     malignancies, the epidermal growth factor receptor (EGFR) is expressed in 25-85%; in certain     histological types, like salivary duct carcinomas, the expression is higher. EGFR is a     promising target of anticancer therapy. In squamous cell carcinoma of the head and neck, a     phase III trial utilizing cetuximab added to radiation therapy improved both locoregional     control and overall survival compared to radiation alone. Panitumumab is a novel, human, IgG2     EGFR monoclonal antibody that may be better tolerated and more efficacious than cetuximab.     Here, the investigators suggest that the addition of panitumumab to standard radiotherapy in     locally-advanced salivary gland malignancies will improve recurrence-free survival (RFS).   "
238999|NCT00984230|"     The purpose of this clinical trial is to identify the infant formula(s) for which the     investigators get the closest gut maturation index compared to the one they get with     breastfed babies.   "
239000|NCT00984243|"     This study is being done to determine whether a substance called hematoporphyrin can be used     to treat tumors in various locations in the body when used in association with a laser.     Hematoporphyrin is a substance that is taken up by cancerous cells. When these cells are     exposed to the energy emitted by a laser source, chemical reactions occur in the cell and     cause the cells to die. It is hoped that this treatment method may be able to selectively     destroy malignant cells without damaging surrounding healthy tissue.   "
239001|NCT00984256|"     The purpose of this study is to determine whether Malarone ®, which is a drug approved to     prevent malaria when taken daily, will still effectively prevent malaria if taken weekly.   "
239002|NCT00984269|"     This is a prospective, randomized, equivalence trial designed to evaluate postoperative     complications following hand surgery with a brachial tourniquet and without a tourniquet in     patients that have previously had a mastectomy with axillary node dissection with or without     radiation treatment or history of lymphedema.   "
239003|NCT00984282|"     Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic     differentiated thyroid cancer refractory to radioiodine   "
239004|NCT00984295|"     This study will assess the safety and immunogenicity of ProQuad when administered     concomitantly and nonconcomitantly with Tripedia and Comvax.   "
239005|NCT00984308|"     Sleep apnea is common among Veterans with cerebrovascular disease (stroke or transient     ischemic attack [TIA]), leads to hypertension, and is associated with recurrent stroke and     death. Although continuous positive airway pressure (CPAP) safely treats sleep apnea, few     Veterans with cerebrovascular disease are diagnosed with sleep apnea or offered treatment.   "
239006|NCT00984321|"     The purpose of this study is to examine whether psychoeducation counseling for older cancer     patients undergoing treatment is feasible and worthwhile. The investigators will test this in     a group or individual phone counseling format. Many cancer patients seek counseling to help     with the emotional burden of their illnesses. Counseling often helps them cope with cancer by     giving them a place to express their feelings. This geriatric-specific psychoeducation is     intended to help older cancer patients cope with the burden of cancer and aging. The purpose     of this study is to see if this type of counseling helps reduce depressive symptoms, anxiety,     perception of loneliness and isolation. In addition this counseling aims to improve coping     and quality of life (QOL).      Individuals who choose not to take part in the intervention study will be asked if they are     willing to participate in a brief refusal sub study. The purpose of the refusal substudy is     to compare levels of distress in patients that choose to participate and those that decline.     This will yield valuable data that will help us distinguish between patients that decline due     to lack of interest in research and those that decline due to high levels of distress.     Participation in the refusal sub study consists of completion of 2 brief questionnaires.   "
239007|NCT00984334|"     For many patients taking opioids for pain relief one of the most distressing side effects is     constipation. Naloxone is effective in the reversal of the effects of opioids and is used     following opioid overdose. If naloxone is given by mouth it would relieve the effects of     constipation but as it goes into the blood stream very quickly, it would also reverse the     effects of the opioid and therefore stop the pain relief. The aim of this study is to examine     a slow release formulation of naloxone to see if is can reduce constipation without reducing     the pain relieving effects of the opioid.   "
239008|NCT00984347|"     The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for     induction of labor in term pregnancies.   "
239009|NCT00984360|"     The purpose of this study is to determine whether methamphetamine-dependent individuals will     use less methamphetamine when treated with naltrexone. The study will also investigate     whether individuals with the mu opioid receptor gene variant A118G will use less     methamphetamine than individuals without A118G.   "
239010|NCT00984373|"     The purpose of this study is to provide accurate, reliable information on schizophrenia     clinical management in order to detect unmet medical needs of this disease in terms of:        -  Patient characteristics.        -  Diagnostic and treatment approaches: initial and subsequent.   "
239011|NCT00984386|"     The purpose of this study is to investigate early wound healing of one application of four     different doses of intradermal Zesteem (17β-Estradiol) in male subjects and female subjects     two years post-menopausal.   "
239012|NCT00984399|"     The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast     cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina.     It relieves vaginal dryness. Women who have had breast cancer are usually told not to take     estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new     primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the     vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise     in your estrogen level. However, there is no clear evidence that this would cause any bad     effects in patients with breast cancer. How much, if any, of these topical estrogens are     absorbed through the vagina is not known. We also do not know what the impact is of low dose     estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the     mucus membranes are restored after estrogen exposure.   "
239013|NCT00984412|"     Refractory acute leukemia (AL) occurs in a significant percentage of the AL patients and     presents a therapeutic challenge. Allogeneic stem cell transplantation (allo-SCT) is the only     curative option for these patients. Although many of the patients with refractory AL that     undergo myeloablative SCT initially achieve complete remission, most relapse later on, and     the long-term disease free survival is poor. In order to achieve better leukemic control,     most transplant centers employ post transplant early withdrawal of the anti-GVHD     immunosuppression; hence exposing the patients to high risk of GVHD associated morbidity and     mortality. This study will try to address this common scenario, namely early and late     relapse. The investigators will try to attain better leukemic control by re-inducing the     patients, 6 weeks after the 1st transplant with further myeloablative treatment (busulfex and     thiotepa) followed by allogeneic stem cell support (transplant II).   "
239014|NCT00984425|"     Over the last decade, improvements in the investigators' understanding of the molecular basis     of cancer have led to the clinical development of protein kinase inhibitors, which target     pivotal molecules involved in intracellular signaling pathways implicated in tumorigenesis     and tumor progression. Lapatinib is an oral selective and reversible inhibitor of the     tyrosine kinase domain of epidermal growth factor receptor (EGFR) and human epidermal growth     factor receptor type 2 (HER-2), which are both frequently altered in human malignant tumors.     Sorafenib is an oral multi-kinase inhibitor with a dual-action that prevents tumor cell     proliferation and angiogenesis. The investigators suggest that through a complete blockade of     ErbB signaling network it may be possible to ''sensitize'' tumor cells to antiangiogenic     therapy, by lowering the tumor cell survival threshold, while through inhibition of vascular     endothelial growth factor (VEGF) pathway to circumvent the problem of acquired resistance to     EGFR inhibitors. Based on this theoretical rationale we decide to test the combination of     Lapatinib and Sorafenib. This phase I trial will be undertaken to assess the maximum dose     tolerated (MTD), safety/tolerability, pharmacokinetics and antitumor efficacy of this     combination in patients with advanced, recurrent or metastatic solid cancers refractory to     available standard treatment.   "
239015|NCT00984438|"     The purpose of this research study is to try and identify a more effective treatment plan to     improve survival rates for patients with a recurrent Glioblastoma Multiforme (GBM) brain     tumor that can be removed by brain surgery.      The study will record what effects (good and bad) the combination of surgery with     chemotherapy wafers inserted in the spot where the patient's tumor was during your surgery     and post-operative chemotherapy has on the patient and their survival rate over the next 12     months.   "
239016|NCT00984451|"     Background:        -  The influenza A virus can cause infections that lead to fever, cough, muscle aches,          diarrhea, and headaches, and can even be fatal in some people. Seasonal influenza kills          an estimated 36,000 people in the United States each year. In addition, more than          200,000 people are hospitalized for flu-related complications. Influenza A has a          substantial health effect on every age group.        -  Currently, treatments are available for influenza A, but there is concern that the rate          of complications or even death from this infection is still high despite treatment, and          that over time this virus may become resistant to these treatments. Researchers are          interested in developing a possible new treatment that uses antibodies against influenza          A virus.      Objectives:      - To collect plasma (the liquid component of blood containing antibodies) from people who     have high levels of antibodies against the influenza A virus because they either have been     previously infected with the virus or have been vaccinated against the infection.      Eligibility:        -  Healthy male volunteers between 18 and 60 years of age who are eligible to donate blood.        -  Individuals must have previously either recovered from influenza infection or have been          vaccinated against the infection, and may be subject to other restrictions on          participating in National Institutes of Health research studies.      Design:        -  Volunteers will undergo apheresis, an outpatient procedure in which researchers will          collect plasma containing antibodies against the influenza virus by drawing blood into a          special machine that separates blood cells from the liquid portion under sterile          conditions and then returns the blood cells to the donor.        -  Volunteers will be screened with blood tests to ensure that they are eligible to          participate and donate blood.        -  Volunteers are asked to undergo at least 3 sessions of apheresis; if willing, they can          volunteer to participate in up to 20 sessions.        -  After plasma is collected, it will be tested to ensure that it can be used to safely          develop treatments for patients who have influenza A infection.   "
239017|NCT00984464|"     The purpose of this Phase 2 study is to investigate whether intravenous administration of     REOLYSIN therapeutic virus in combination with paclitaxel and carboplatin is effective and     safe in the treatment of metastatic melanoma.   "
239018|NCT00984477|"     The purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by     the body when given to healthy, non smoking males at different dose levels. This is a 2 part     study, in Part B a single group of subjects will be given both an oral dose and intravenous     microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.   "
239019|NCT00984490|"     RATIONALE: Metformin hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase I trial is studying how well metformin hydrochloride works in treating     women with stage I or stage II breast cancer that can be removed by surgery.   "
239020|NCT00984503|"     The purpose of this study is to investigate the accelerated-healing potential of injection or     injection plus topical application of Juvista to minor split skin grafts (SSG).   "
239021|NCT00984516|"     The purpose of this study was to investigate the scar-improvement efficacy of three doses of     intradermal Juvidex given once only or three times in male and female subjects and to collect     further safety and tolerability data for intradermal Juvidex in male and female subjects.   "
239022|NCT00984529|"     The purpose of this study is to determine whether treatment with candesartan cilexetil for at     least 6 months in patients with chronic heart failure improves clinical signs and symptoms of     chronic heart failure.   "
239023|NCT00984542|"     RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line     therapy in treating patients with relapsed or refractory small cell lung cancer.   "
239024|NCT00984555|"     The purpose of this study is to examine the vaginal residence time of certain semen     biomarkers.   "
239025|NCT00984568|"     This study will be performed to compare the efficacy and safety of the classical Step-Up     approach for treatment of moderate-to-severe active ulcerative colitis using oral     prednisolone + oral 5-aminosalicylic acid (5-ASA) or oral prednisolone + oral azathioprine     (AZA) with a more intensive and early Top-Hold approach with intravenous infliximab (5     mg/kg) administered at Weeks 0, 2, and 6 and 8 weeks thereafter.   "
239026|NCT00984581|"     To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal     avotermin (Juvista) in young females.   "
239028|NCT00984607|"     The purpose of this study is to correlate accurate fluoroscopic measurement of gastric band     stoma diameter with patient symptoms for optimal band stoma adjustment. Administration of a     barium tablet to gastric band patients with dilute liquid barium allows the accurate     measurement of the band stoma diameter. The technique is quick, easy to perform, and     eliminates magnification error intrinsic to fluoroscopy. The study data suggests the optimal     calibrated gastric band stoma diameter is 3.0 mm. The accurate fluoroscopic measurement of     gastric band stoma diameter can optimize band stoma adjustment and improve patient outcomes.   "
239029|NCT00984620|"     To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI     201335 at a dose of 120 mg once daily, with a 24-week background of pegylated     interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with     hepatitis C virus (HCV) genotype 1   "
239030|NCT00984633|"     The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org     9426 in maintenance of muscle relaxation in adult subjects undergoing general elective     surgery.   "
239031|NCT00984646|"     The purpose of this study was to investigate the scar-reducing properties of eight doses of     intradermal Prevascar (IL-10).   "
239032|NCT00984659|"     The purpose of this study is to evaluate a new questionnaire to capture the patient     experience of COPD. The information collected will be used to validate the Shortness of     Breath with Daily Activities Questionnaire.   "
239033|NCT00984672|"     Clinician directed use of bone morphogenetic proteins (BMPs) in ways other than FDA approved,     has increased recently due to the morbidity associated with harvest of iliac crest bone graft     in spinal arthrodesis procedures. FDA approved for the use in anterior lumbar fusions with LT     Cage, other clinical applications of these proteins is becoming widely adopted due to their     effectiveness in forming bone and facilitating fusion. Clinicians have realized while these     proteins are potent stimulators of bone formation there have been anecdotal reports of     increased rates of radicular pain in the postoperative period when used in interbody     arthrodesis procedures. Speculation as to the mechanism of this radiculitis is postulated to     be due to the inflammatory effects of these proteins. Excess bone overgrowth around the     spinal nerves in proximity to the fusion cage has been reported. No prospective studies have     been performed assessing the incidence and etiology of this complication. The investigators     propose a prospective study evaluating the incidence of this complication as well as     postoperative imaging studies to help determine whether bony overgrowth is indeed occurring     adjacent to the effected spinal nerves.   "
239034|NCT00984685|"     The purpose of the study is to identify the barriers for effective treatment of depression,     specifically whether modified CHIS Scale is a valid tool for identifying the high risk     patients for depression.   "
239035|NCT00984698|"     The purpose of this study is to test the effectiveness of group psychotherapy designed     specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder     (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily     routine.   "
239036|NCT00984711|"     This study was designed to gather data regarding the efficacy and safety of Rituxan in     clinical practice whereby patients may present with concomitant medical conditions,     medications as well as varying presentations of rheumatoid arthritis not always captured     within the purer population seen in an industry sponsored clinical trial.   "
239037|NCT00984724|"     The goal of this research study is to learn the effectiveness of telephone-based counseling     on helping smokers change their smoking patterns.   "
239038|NCT00984737|"     Newly diagnosed hyperglycemia (NDH) and stress hyperglycemia (SH) during acute illness is     reported as a non-physiological condition in hospitals. The investigators aim is to determine     the rate of NDH and SH among cases admitted to coronary ICU with acute coronary disease and     to inquire the relationship of SH with disease severity and functional outcomes such as     longevity of ICU stay.   "
239039|NCT00984750|"     Decreased insulin sensitivity (or insulin resistance) is a major risk factor for type 2     diabetes mellitus and renal and cardiovascular disease. It is the key component and,     possibly, a pathogenetic factor of the metabolic syndrome - a clustering of arterial     hypertension, obesity, impaired glucose tolerance, dyslipidemia, coagulation abnormalities,     albuminuria and increased cardiovascular risk - that may precede or accompany type 2     diabetes.      Insulin function and the abnormalities associated with insulin resistance, may have a major     role in preventing type 2 diabetes and, in the long-term, diabetes micro- and macrovascular     complications. Carnitine is involved in lipids and carbohydrates metabolism and     acetyl-L-carnitine (ALC), an intramitochondrial carrier of acylic group, may modulate cell     fuel substrate utilization. Studies found that carnitine may improve insulin sensitivity and     glucose disposal in healthy subjects and in patients with type 2 diabetes. A recent study     found that a primed constant infusion of acetyl-L-carnitine (ALC) may increase glucose     utilization in type 2 diabetic patients, possibly restoring the glycogen synthase activity.      In a previous pilot study in healthy subjects with decreased insulin sensitivity, the     investigators found that 6-month treatment with Acetyl-L-Carnitine - an ester of l-carnitine     - improved the glucose disposal rate, taken as a marker of insulin sensitivity. Amelioration     of insulin sensitivity was associated with a significant and clinically relevant reduction in     systolic blood pressure without appreciable changes in diastolic blood pressure. Whether     blood pressure reduction reflected the amelioration of insulin sensitivity or, rather, a     direct, specific effect of Acetyl-L-Carnitine is still unknown.The antihypertensive effect     ensued progressively and slowly waned after treatment withdrawal as documented by a slow and     progressive increase in blood pressure levels toward baseline levels over the recovery     period. This finding provided convincing evidence that blood pressure reduction throughout     the observation period was not explained by a trial effect, but reflected a true treatment     effect. Blood pressure was a secondary efficacy variable of the study and mechanisms     underlying the antihypertensive effect of Acetyl-L-Carnitine (such as reduced peripheral     resistances, decreased cardiac output, increased artery compliance and/or enhanced sodium     excretion), in this population were not assessed.      Acetyl-L-Carnitine was well tolerated in all of the patients and may provide a novel     therapeutic tool for the treatment of arterial hypertension, and of dyslipidemia and could be     safely used in people with type 2 diabetes.      Thus, the investigators designed a prospective, randomized, double-blind, placebo-controlled     trial to investigate whether Acetyl-L-Carnitine added-on stable and standardized blood     pressure and lipid lowering therapy may help further improving control of hypertension and     dyslipidemia and, therefore, decreasing the overall cardiovascular risk in hypertensive     patients with type 2 diabetes.   "
239040|NCT00984763|"     Malaria is a parasite, infection with which kills over 2 million people each year. It is a     major problem for those who live in endemic areas and for travellers. There is a great need     for a safe effective malaria vaccine. The purpose of this study is to examine a new vaccine     designed to provide immunity during the blood stage of the malaria parasite's lifecycle.      The vaccine consists of AMA1-C1 which is a mixture of two recombinant synthetic AMA1 proteins     from two Plasmodium falciparum strains, Alhydrogel® which is an aluminium-based adjuvant and     CPG 7909 - an oligodeoxynucleotide, which enhances immune response.      This study will enable the investigators to assess:        1. The ability of of a growth inhibition assay to predict the effectiveness of a malaria          vaccine.        2. The safety of the vaccine in healthy volunteers        3. The response of the human immune system to the vaccine   "
239041|NCT00984776|"     MRI has the ability to visualize the arterial vessel wall. Wall thickening and     atherosclerotic plaque components can be visualized in the carotid arteries and the aorta.     Previous studies also demonstrated the ability of MRI to visualize the coronary vessel wall.     The ultimate goal of coronary vessel wall imaging is to detect vulnerable atherosclerotic     plaque thereby. This might prevent complications, e.g., chest pain (angina) or myocardial     infarction.      The goal of this study was to validate MRI of the coronary vessel wall by comparing it to     intravascular ultrasound (IVUS), to detect atherosclerotic plaque in the coronary vessel wall     and to look at the uptake of the albumin-binding contrast agent gadofosveset in     atherosclerotic plaques. The main hypothesis is that due to the albumin binding     characteristics, uptake of the contrast agent will take place in the more vulnerable plaques     compared to less vulnerable plaques. MRI will be compared to X-ray coronary angiography and     intravascular ultrasound, two techniques currently considered as the standard of reference     for imaging of the coronary arteries and vessel wall.   "
239042|NCT00984789|"     400 healthy women needed contraception will be asked to participate in this study. Half will     be given EVRA, half will be given FC Patch low. They will be expected to apply the patches     for 21 days of their cycle, for 7 cycles in total. The study will compare the patterns of     menstrual bleeding on these two treatments, plus how effective they are at preventing     pregnancy, general safety, and their acceptability to the participants.   "
239043|NCT00984802|"     This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV)     injection, and to evaluate efficacy on the basis of the changes seen in the cardiac     biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of     the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be     explored.   "
239044|NCT00984815|"     The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a     fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients     that require long-term NSAID treatment.   "
239045|NCT00984828|"     The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. All     patients will receive 4 cycles of velcade and Dexamethasone as front-line therapy. Then     patients will be randomized into standard group which will receive a single autologous     hematopoietic stem cell transplantation with standard conditioning of melphalan 200mg/m2 and     the study group which will receive single autologous hematopoietic stem cell transplantation     with conditioning of melphalan 200mg/m2 + velcade followed by 3 more cycles of velcade alone     as consolidation.   "
239046|NCT00984841|"     The purpose of this study is to determine if tailored letters sent to diabetic patients will     improve care of diabetes.   "
239047|NCT00984854|"     The purpose of this study was to investigate the safety and toleration of various doses of     intradermal Juvidex (mannose-6-phosphate) administered to punch biopsies of normal subjects.   "
239048|NCT00984867|"     This study aims to investigate how dapagliflozin can control blood sugar in patients with     type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with     metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.   "
239049|NCT00984880|"     The primary purpose of this study is to assess the safety and tolerability of AZD3043     following administration of single ascending bolus doses (Part A) and single ascending bolus     doses followed by infusion (Part B).   "
239050|NCT00984893|"     The study will assess the real life effectiveness of zoledronic acid in the management of     patients with osteoporosis over 4 years of treatment. Zoledronic acid will be compared to     oral bisphosphonates (OBP) with respect to the change in Bone Mineral Density (BMD) and     incidence of fractures.   "
239051|NCT00984906|"     The aim of the study is to measure the inspiratory flow that the different patient groups     (asthmatic children, adults and elderly, as well as chronic obstructive pulmonary disease     (COPD) patients) generate through empty Easyhaler (two versions) and Turbuhaler inhalers. In     addition, the handling and acceptability of the inhalers will be compared in asthmatic     children.   "
239052|NCT00984919|"     RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory     may help doctors identify biomarkers related to cancer.      PURPOSE: This research study is looking at a biomarker, 11-dh-TXB2, in blood and urine     samples from patients with prostate cancer and healthy volunteers.   "
239053|NCT00984932|"     Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the     initial event and statins through their vasculoprotective effect might be of value in the     treatment armamentarium of PAH related to SSc.      The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and     in the management of SSc-related PAH.   "
239054|NCT00984945|"     The primary objective is to assess the safety and tolerability of two consecutive doses of     plant-based H5 VLP, (H5N1) pandemic influenza vaccine combined with Alhydrogel®, given 21     days apart, at three dose levels: 5µg, 10µg and 20µg., compared to the placebo, and combined     with Alhydrogel®.   "
239055|NCT00984958|"     The aim of this prospective, randomized study of Bulkamid treatment is to investigate the     efficacy of Bulkamid treatment in women with urinary stress incontinence not suitable to     TVT-procedure because of suspected ISD.   "
239082|NCT00985309|"     According the terminology of Bethesda 2001, the unsatisfactory cervical cytology can be     categorized into specimen rejected, or specimen processed and examined, but unsatisfactory     for evaluation of epithelial abnormality. Most of the unsatisfactory cervical cytology was     due to scanty epithelial cells, which was defined by less than an estimated 8,000 to 12,000     well-visualized squamous cells for conventional smears. Follow-up of unsatisfactory smear     found an increased rate of cervical preinvasive and invasive lesions. Thus, an unsatisfactory     smear deserves careful follow-up and studies. Although the Bethesda system allows criteria     modification in cases of hysterectomy, pelvic irradiation therapy, or chemotherapy, no     studies investigated the clinical factors related to the incidence of unsatisfactory smear.     Thus, the investigators designed this trial to study the clinical factors relating to     unsatisfactory cervicovaginal smear.The list of patients who received Papanicolaou smear     between March 2006 and August 2006 in our hospital will be obtained from the Pathological     Department first. Then the investigators will review the medical records from HIS system and     pathologic files of these patients. On estimation, 7,437 cases will be enrolled for analysis.     Clinical parameters for analysis include: age, gravidity, parity, abortion, menopause,     location of Pap smear, history of pelvic malignancy, pelvic irradiation, cervical conization,     hysterectomy; at pregnancy; three months postpartum; vaginal bleeding, vaginal abnormal     discharge, intrauterine device, and cervical polyp found during pelvic examinations. Patients     who missed any of above data will be excluded for analysis. The investigators will use     univariate and multivariate analysis for data processing and statistic analysis to find out     the relationship between clinical parameters and unsatisfactory cervicovaginal Pap smears.   "
239056|NCT00984971|"     To date, the majority of microbicide research has focused on the assessment of the safety and     effectiveness of vaginal microbicides used for the prevention of HIV transmission via the     vaginal compartment. Receptive anal intercourse (RAI) is common among men who have sex with     men (MSM), and there is increasing evidence that heterosexual women in the developed and     developing world also practice anal sex. It can, therefore, be anticipated that once vaginal     microbicides are licensed, they will be used in both the vaginal and rectal compartments. As     a consequence, there is a need to evaluate both the rectal and vaginal safety profile of     candidate microbicides. Therefore, the primary objective of this study is to evaluate the     systemic safety of 1% vaginally formulated tenofovir gel applied rectally. In addition, this     study will evaluate the immunotoxicity of the gel and evaluate its acceptability; it will     also use the oral tenofovir disoproxil fumarate tablets (TDF), rectally-applied tenofovir     gel,and a placebo gel to compare their systemic and compartmental pharmacokinetic (pK)     profiles.      This study was designed to address the following hypotheses:        -  Vaginally-formulated tenofovir 1% topical gel when applied rectally will be safe using a          combination of clinical and laboratory markers including assays specifically designed to          measure mucosal toxicity        -  Tenofovir will be detectable at different concentrations in the various anatomic          compartments sampled for pharmacokinetics following single and 7-day topical exposures        -  Exposure to tenofovir 1% gel will demonstrate prevention of ex vivo HIV-1 challenge          using in vivo drug-exposed tissue as compared to baseline tissue samples        -  Orally delivered, single dose, 300 mg tenofovir disoproxil fumarate tablets will have          similar safety profiles using routine blood safety indices as have been established in          other trials and will show no mucosal safety concerns        -  The oral dose will have different multi-compartment concentration kinetics than the          topical tenofovir and will also demonstrate preliminary (ex vivo) prevention using the          explant infectivity assay        -  Vaginally formulated tenofovir 1% topical gel applied rectally will be acceptable to          participants, as indicated by a score in the upper one third of the 10-point Likert          scale on intentionality to use in the product in the future   "
239057|NCT00984984|"     The efficacy of oral corticosteroids for the treatment of relapses of multiple sclerosis has     not been proved. French neurologists treat such patients with intravenous corticosteroids.     The aim of the study is to check if the efficacy of high dose oral methylprednisolone is     similar to the efficacy intravenous (IV) prednisolone. The main criteria of efficacy is     symptom recovery within 28 days after inclusion.   "
239058|NCT00984997|"     1. To determine the outcome of patients with potentially resectable superior sulcus tumors          of non-small cell histology treated by surgery followed by accelerated radiation therapy          and chemotherapy.        2. To evaluate toxicity, the initial local-regional control rate, sites of and time to          local and distant failures.   "
239059|NCT00985010|"     Objective:      Report manganese serum levels and mortality in encephalopathic patients.      Patients and participants:      Consecutive patients aged > 18 years, with hepatic encephalopathy and informed consent signed     by their families.      Interventions:      Patients' clinical characteristics as well as biochemical tests of renal function,     hemoglobin, glucose and albumin levels were obtained as well as a blood sample to analyze     manganese levels with a graphite furnace atomic absorption spectrometer.      Hypothesis:      There is a difference in the manganese levels between male and female patients.   "
239060|NCT00985023|"     The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion     of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of     motion and shape to the foot. In certain foot fractures where the Lisfranc ligaments are     damaged, the constraint and stability it had given to the middle of the foot is lost.     Attempted activity at the foot will result in pain and abnormal motion. If injury to the     Lisfranc ligaments is left untreated, the eventual end result is foot arthritis and     deformity.      The current standard orthopaedic treatment of foot fractures with Lisfranc ligament injuries     is surgery. The foot fractures are fixed with metal screws. The Lisfranc ligaments are fixed     by compressing the space between the middle bones of the foot with steel screws. These screws     allow for ligament healing. As the ligaments heal, the patient should not resume activity     with the fixed foot too soon as the screw may break. Upon breakage, the ligament repair may     fail and the screw is now difficult to surgically remove. Regardless of breakage, a second     surgical procedure is often recommended to remove the steel screw 6 months after foot     surgery. This allows for a complete return of normal foot range of motion, but at the cost of     a second surgical procedure.      The investigators hypothesize that absorbable screw fixation of the Lisfranc ligaments does     not yield significant differences in postoperative foot stability, ligament function, and     symptoms when compared to steel screw fixation. In addition, absorbable screw fixation of the     Lisfranc ligaments offers the advantage that a second surgical procedure to remove the screw     is not necessary.   "
239061|NCT00985036|"     Objectives: This study is looking at the level of vascular endothelial growth factor (VEGF)     circulating in the blood stream of patients diagnosed with either a meningioma or a glioma.     The questions that will be addressed include:        1. Can VEGF level alert us to tumor progression or recurrence before MRI changes occur?        2. Is the VEGF level an indicator of the response to treatment?        3. Does the VEGF level correlate with tumor histology and behavior?        4. Is there a relationship between VEGF level and outcome?   "
239062|NCT00985049|"     Hypothesis: The investigators hypothesize that genetic variants will alter gene expression in     response to ischemia during cardiopulmonary bypass. To test this, the investigators will be     taking small pieces of heart tissue from patients undergoing heart surgery before and after     this period of ischemia. This will be compared to blood gene expression in blood cells and     analyzed with the patients' genetic profile. This might allow us to assess the amount of     inflammation that occurs when patients are on the heart-lung machine as well as examine the     effects genes have on this critical time period.   "
239063|NCT00985062|"     In vitro fertilization (IVF) is an assisted reproductive technique to achieve pregnancy in     subfertile couples of which the average success rate is only 25%. Mild ovarian stimulation     treatment yields less oocytes, has less adverse effects but has a comparable clinical outcome     compared to conventional stimulation treatment. There is high inter- and intra person     variability in ovarian response and fertility outcome parameters after stimulation treatment     and little is known about explanatory variables herefore.      Nutrition and in particular folate, or its synthetic derivative folic acid, is a B-vitamin     which has been widely asssociated with reproductive outcome and subfertility. Therefore, in     this study we aim to investigate the influence of preconception nutrition and folic acid use     on ovarian response after mild/conventional stimulation treatment and to identify biomarkers     in the follicular fluid which can indicate oocyte quality and other fertility outcomes.   "
239064|NCT00985075|"     The objective of this study is to evaluate ocular and nasal signs and symptoms in patients     with seasonal allergic rhinoconjunctivitis following allergen exposure in the Allergen     BioCube.   "
239065|NCT00985088|"     The purpose of this study is to characterize the safety and immunogenicity of the H1N1     (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.      This protocol posting has been updated for sections impacted by the Protocol amendment 1,     Sept 2009.   "
239067|NCT00985114|"     The purpose of this study is to evaluate the safety and efficacy of a second generation     EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes.      This is a randomized, controlled study which will enroll approximately 70 Subjects with Type     2 Diabetes. Randomization will be one to one with approximately 35 EndoBarrier device     Subjects and approximately 35 study diet Subjects. Subjects randomized as diet Subjects will     be offered the EndoBarrier device after 12 months on study at the investigator's discretion     if treatment of the device subjects indicates adequate efficacy. This study will be conducted     at three (3) investigational sites.      The primary efficacy endpoint is:        -  Assessment of the percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24          weeks or last visit from baseline between the two groups.      Secondary endpoints are:        -  Percent (%) of Subjects who achieve a HbA1C of 7.0% or lower at week 24 or last visit          from baseline.        -  Percent (%) of Subjects who have their diabetic medication(s) dosage decreased or          discontinued at week 24 or last visit from baseline.        -  Percent (%) of Subjects who achieve a decrease in post-prandial excursions as evidenced          by challenge to a standardized meal tolerance test (MTT) at week 24 or last visit from          baseline.        -  Assessment of absolute weight loss (Kg) at week 24 or last visit from baseline.        -  Percent (%) of Subjects who maintain a HbA1c lower than their baseline assessment at 12          months.        -  Compare physical component summary (PCS), mental component summary (MCS) and quality          adjusted life years (QALYs)via analysis of the SF-36v2 QOL.   "
239068|NCT00985127|"     The study will be conducted in two parts. The first is a parallel-group design, evaluating     doses of 40 mg, 80 mg or 120 mg BCX-4208. The second part is planned as a dose-escalation     study, evaluating higher doses including 160 mg, 240 mg and 320 mg BCX-4208. The study's     primary endpoint is the change in uric acid in the blood compared to baseline measurement     prior to treatment, assessed on Day 22.   "
239069|NCT00985140|"     To examine the efficacy and safety of total skin electron beam therapy to a dose of 12 Gray     (TSEBT 12 Gy) in patients who have mycosis fungoides (MF) staged as IB to IIIA.   "
239070|NCT00985153|"     This study will compare three consistency lots of ProQuad to each other as well as to M-M-R     II and Varivax, administered concomitantly at different injection sites, with respect to     immunogenicity, safety, and tolerability.   "
239071|NCT00985166|"     The study was conducted to determine if ProQuad may be used in place of the second dose of     M-M-R II routinely given to children 4 to 6 years old who were previously immunized with     M-M-R II and Varivax.   "
239072|NCT00985179|"     To help employees to adopt and maintain a healthy lifestyle, it is imperative to increase     their self-management competencies. Aim of this research project is to evaluate an evidence-     and theory-based computerized expert system in comparison to waiting control group. Employees     will be treated psychologically and followed up over 18 months. The computerized expert     system is expected to help employees significantly changing their lifestyle. The intervention     is hypothesized to improve self-management competencies over and above the regular check-up     at their medical appointment (i.e., waiting control group).   "
239073|NCT00985192|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with     previously treated unresectable or metastatic esophageal cancer or stomach cancer.   "
239074|NCT00985205|"     The purpose of this study is to test the following hypotheses:        1. Enteral glutamine administration decreases in-hospital mortality in adult patients with          severe thermal burn injuries.        2. Enteral glutamine administration decreases hospital-acquired blood stream infections          from Gram negative organisms and length of stay in ICU and hospital for adult patients          with severe thermal burn injuries.        3. Enteral glutamine administration will improve the physical function of surviving burn          injured patients and reduce their cost of care.      The objectives of this trial are to determine the overall treatment effect and safety of     glutamine in burn patients. Specifically, the investigators want to assess the following     outcomes in a sample of 2,700 patients in 80 sites:        1. In patients with severe, life-threatening burn injury, what is the effect of enteral          glutamine on 6 month mortality?        2. In patients with severe, life-threatening burn injury, what is the effect of enteral          glutamine on time to discharge alive from hospital, hospital-acquired blood stream          infections from Gram negative organisms, hospital mortality, duration of stay in ICU and          hospital, health-related quality of life, and health care resources?   "
239075|NCT00985218|"     The purpose of this study is to compare the development of human embryos grown in a     conventional culture dish to those grown in a new embryo culture device known as the SMART     System.   "
239076|NCT00985231|"     This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses     compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens     wearers on a daily wear basis.   "
239077|NCT00985244|"     To assess whether maintenance treatment with macrolide antibiotics in COPD patients with     three or more exacerbations in the preceding year of inclusion can decrease the exacerbation     rate in the year of treatment.   "
239078|NCT00985257|"     The purpose of this study is to evaluate the performance of a new blood glucose meter in the     hands of children, teens, young adults.   "
239079|NCT00985270|"     This clinical trial is designed to study the effects of rifampicin on the glucose, lipid and     hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin lowers     fasting glucose and enhances insulin sensitivity. The study is a randomized,     placebo-controlled, open-label cross-over trial. Twelve subjects will be given 600 mg of     rifampicin a day for a week compared to a one-week placebo arm. There is at least a 4-week     wash-out between the arms. The main outcome measures are the changes in the fasting glucose     and HOMA-IR-index (calculated based on fasting glucose and insulin).   "
239080|NCT00985283|"     The goals of this project are to implement an innovative intervention for older adults and     assess both its feasibility and effects on health and well-being. The investigators     hypothesize that the intervention group will show a significantly better slope for a range of     outcomes during and after the intervention.   "
239081|NCT00985296|"     To evaluate the effect of Conjunctival Allergen Challenge (CAC) with Dust Mites on nasal and     ocular allergic symptoms following allergen exposure in the Allergen BioCube (ABC).   "
239083|NCT00985322|"     Background: Angiotensin-converting-enzyme (ACE) inhibitors have a specific cardioprotective     effect and, compared to treatment not directly interfering with the renin-angiotensin-system     (RAS), significantly reduce cardiovascular (CV) mortality and morbidity in subjects with     normal renal function.      Despite CV events are the leading cause of death in these patients, no adequately powered     trial so far evaluated the specific cardioprotective effect of ACE inhibitors in this     population.      Objectives: This prospective, randomized, open label, blinded end point (PROBE) trial is     primarily aimed at evaluating whether, at comparable blood pressure (BP) control, ACE     inhibitor as compared to non-RAS inhibitor therapy significantly reduces the incidence of a     composite end point of CV death (including sudden death) and non-fatal myocardial infarction     or stroke in 624 patients with arterial hypertension (pre-dialysis systolic/diastolic BP     >140/90 mmHg or post-dialysis systolic/diastolic BP >130/80 mmHg or antihypertensive therapy)     and/or echocardiography evidence of LVH (cardiac mass index >130 g/m2 for men and 100 g/m2     for women) who are on dialysis therapy since at least six months. Secondarily, the study will     compare the incidence of single components of the primary outcome, new onset paroxysmal or     persistent atrial fibrillation, thrombosis of the artero-venous fistula, new onset,     progression or regression of LVH, changes in components of the metabolic syndrome, the safety     profile of the two treatment regimens and their cost/effectiveness.      Methods: After 1 month wash-out period from previous RAS inhibitor therapy and a baseline     evaluation of main clinical and laboratory parameters, patients will be randomized on a 1:1     basis to 2-year treatment with an ACE inhibitor or a BP lowering regiment not including RAS     inhibitors. A balanced distribution according to centre, number of dialysis sessions per week     (2 or 3), presence of diabetes (YES/NO), arterial hypertension (YES/NO), LVH (YES/NO) will be     achieved by the minimization method. Treatment will be adjusted to achieve and maintain a     target BP <140/90 mmHg (pre-dialysis) and a target BP <130/80 mmHg (post-dialysis) in both     groups.      Expected results: ACE inhibitor compared to non-RAS inhibitor therapy is expected to reduce     more effectively fatal and non-fatal CV events, prevent or limit progression or induce     regression of LVH, improve some components of the metabolic syndrome, and reduce treatment     costs for cardiovascular complications. These findings might help achieving more effective     cardioprotection in people on chronic dialysis at lower costs.   "
239084|NCT00985335|"     This study intends to test the efficacy of the TheraNeem Lip Therapy balm for Herpes Simplex.     The study will include a total of 5 people.   "
239085|NCT00977678|"     The capacity for endoscopical procedures in the Norwegian health system is low in comparison     to demands from patients and family practitioners.      The studies aim is to evaluate the acceptance of a new concept: an open access gastroscopy     clinic where patients can attend without a preceding appointment.      The investigators wish to evaluate:        1. Patient´s satisfaction.        2. General practitioner´s satisfaction.        3. Acceptance by the staff of the clinic.   "
239086|NCT00977691|"     Background:        -  Bone marrow transplantation (BMT), which involves transplanting a donor s marrow stem          cells, is capable of curing some congenital anemias. BMT usually involves high-intensity          treatment with chemotherapy and radiation to kill abnormal cells, which affects all          systems of the body.        -  People with anemias often have damage to other organs such as the kidneys, which can be          further damaged by the chemotherapy. Only approximately 20 percent of patients have a          full-matched donor, making treatment for many people with anemias unavailable. However,          90 percent of patients may have a half-matched donor, but using a half-matched donor          increases the toxicity of BMT.      Objectives:        -  To determine if a research BMT with half-matched donor cells, low-intensity radiation,          immunosuppressant drugs, and no chemotherapy will be effective in patients with sickle          cell disease and Beta-thalassemia.        -  To determine the effectiveness of cyclophosphamide, an immunosuppressant drug, in          preventing rejection of the donor cells.      Eligibility:        -  Recipients are individuals at least 18 years of age who have been diagnosed with sickle          cell disease and Beta-thalassemia, and who have a family member who is a haploidentical          (i.e., half match) tissue match.        -  Donors are healthy individuals between the ages of 2 and 80 who are found to be suitable          donors.      Design:        -  Donors will undergo apheresis, which involves withdrawing blood from one arm vein,          passing it through a machine that removes bone marrow stem cells, and returning the          remaining blood through the vein in the other arm. Donors will receive a drug that          causes the stem cells to be released into the bloodstream prior to the apheresis          procedure.        -  Recipients will undergo routine physical and laboratory examinations, including bone          marrow sampling at the beginning of the study. After transplantation, physical and          laboratory examinations will occur on a weekly or twice weekly basis at the outpatient          clinic. Recipients will be examined every 6 months starting 100 days posttransplant for          5 years.        -  Recipients will receive low-dose radiation in two treatments 1 and 2 days before the          transplant. They will also be given immunosuppressant therapy with alemtuzumab and          sirolimus. Another immunosuppressant drug, cyclophosphamide, will be given in the future          as needed to subsets of the recipients to prevent rejection of donor cells.        -  Recipients will receive the donor stem cells through a previously inserted central line.          The process takes up to 8 hours.        -  Recipients will receive blood transfusions as necessary to prevent anemia and bleeding          during the posttransplant period. They may also receive intravenous antibiotics to          prevent infection.   "
239087|NCT00977704|"     This is an open-label study to assess safety using Restylane and Perlane in the correction of     facial wrinkles.   "
239088|NCT00977717|"     In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based     chemotherapy, germinal gene polymorphisms will be analyzed.   "
239089|NCT00977730|"     The purpose of this study is to evaluate the effect of Protandim on the degree of liver     injury after one year of supplementation. Protandim is a nutritional supplement composed of     the following 5 botanical extracts: Bacopa Moniera extract, Milk Thistle extract, Ashwagandha     powder, Green tea, and Turmeric extract. Protandim is commercially available and can be     purchased without a prescription. Our findings could lead to a better understanding of the     role of oxidative stress and antioxidant therapy in NASH and may ultimately help improve     patient care.      Hypothesis #1: Protandim will lead to a significant improvement in NAS compared to placebo.      Hypothesis #2: Protandim will lead to a significant decrease in serum markers of oxidative     stress and liver chemistry tests.      Hypothesis #3: Protandim will lead to decreased levels of TNF- α compared to placebo.   "
239090|NCT00977756|"     This study will examine drug and body interactions in children receiving anti-HIV treatment     regimens using new medications. Drug regimens to be examined will feature the medications     raltegravir (RAL), maraviroc (MVC), and etravirine (ETV). These drugs will not be provided     through the study.   "
239091|NCT00977769|"     A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with     hemodynamic response as a primary outcome measure.   "
239092|NCT00977795|"     Extent of resection is a very important prognostic factor affecting survival in individuals     diagnosed with a malignant glioma. However, the infiltrative nature of the malignant glioma     tumor cells produces indistinct borders between normal and malignant tissues, and the lack of     easily identifiable tumor margins confounds attempts at total resection. The investigators     propose to identify the borders of malignant gliomas intraoperatively using oral     5-aminolevulinic Acid (5-ALA) which results in fluorescence of the malignant cells and     thereby provide an opportunity for more complete tumor resection.      When exogenous 5-ALA is provided at increased concentration the tumor cells will become     fluorescent under ultraviolet light. This feature identifies the tumor cells intraoperatively     and facilitates complete resection.      The following data will be collected:        -  Dose-limiting toxicity data        -  Tumor fluorescence assessed by neurosurgeon (0 to +++) in three distinct areas of          fluorescence (Strong fluorescence, Weak fluorescence, No fluorescence)        -  Tumor density from biopsies obtained by the neurosurgeon in the same three distinct          areas of fluorescence and assessed by neuropathology (Solid tumor, Tumor mixed          infiltrating normal brain, No tumor)        -  Neurosurgeon's intra-operative estimate of residual tumor        -  Neuroradiologist's estimate of post-operative residual tumor on MRI        -  Time to progression by MRI        -  Survival (time to progression, one year survival rate and total survival      This trial will evaluate:        -  The toxicity of a single dose of oral 5-ALA given pre-operatively.        -  The sensitivity and specificity of 5-ALA - Protoporphyrin IX (Pp IX) as an          intraoperative fluorescent detection agent and aid for resection of tumor tissue          remaining in the walls of the resection cavity of primary and recurrent malignant brain          tumors.        -  The relationship of the neurosurgeon's estimate of the extent of malignant glioma          resection (as guided by tumor fluorescence) to the actual extent of resection determined          by post-operative imaging.        -  The time-to-progression, one year survival rate and total survival as a function of the          extent of resection.      Following completion of the phase 1 portion of this trial, an additional 15 subjects will be     entered at the recommended phase 2 dose level in order to further define the above parameters     at the recommended phase 2 dose level.   "
243100|NCT01030679|"     The purpose of this study is to assess the safety and effectiveness of three doses of CKD-501     compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes     for 8 weeks.   "
239093|NCT00977808|"     This study plans to link two existing technologies, the insulin pump and the continuous     glucose monitor (CGM), to essentially develop an artificial pancreas, i.e., closed-loop. This     will be done using two continuous glucose monitors (CGMs), a computer containing an     investigational control algorithm that uses glucose information from the CGM to recommend     insulin dosing, and an insulin pump. The purpose of this study is to test the ability of     continuous glucose monitors together with an insulin pump and a mathematical formula to     control blood sugar levels of people with type 1 diabetes.      The Closed-Loop control algorithm will:        1. Suggest adequate insulin delivery for blood glucose control in steady state (overnight);        2. Cover adequately with an insulin bolus the pre-set carbohydrate content of a breakfast.      If successful, this study will conceptually prove the feasibility of automated     model-predictive closed-loop glucose control in T1DM.   "
239094|NCT00977821|"     For an efficient egg banking system, an equally efficient cryopreservation strategy that     ensures the viability of the oocytes is required. Very recently, improved and new methods are     yielding satisfactory results. In particular, vitrification is providing excellent results     for both survival and clinical outcomes. However, to evaluate the over all out come there are     other parameters to be considered. In this sense, capacity development of embryos generated     after oocyte vitrification is a major factor when assessing the viability of vitrified     oocytes. Accordingly, the evaluation of the capacity of vitrified oocytes to reach the     blastocyst stage will be highly valuable to fully assess the effectiveness of the egg     banking and its contribution to ovum donation programs.      The aim of this study is to evaluate the developmental capacity of vitrified oocytes by their     ability to reach the blastocyst stage. The study includes oocyte donation cycles conducted     with vitrified versus fresh oocytes.   "
239095|NCT00977834|"     The purpose of this study is to evaluate the possibility of using a computer-based survey to     gather information from older patients and their caregivers about the patient's daily     activities, need for assistance, other medical problems, mood, nutrition and symptoms.     Researchers will evaluate how many subjects are able to complete the survey on their own and     the length of time needed to do so. Also, researchers will analyze the types of responses to     each item and whether subjects are satisfied with the questionnaire.   "
239096|NCT00977847|"     In the 21st century, the importance of family health history will increase as it will be     essential to put detailed personal genetic information into the context of an individual's     health, namely the context of how the shared code has played out in an individual and his/her     closest relatives. These scientific developments in the investigators' understanding of     genetics will demand a more comprehensive family history dataset for all patients, and the     time limitations on healthcare providers demand a technology-driven solution that integrates     an individual's knowledge of their family history with the medical records maintained by     their health care providers. A solution does not currently exist by which most Americans can     organize their family health history and then place it into their electronic health record     (EHR). The investigators propose to develop and compare three different ways of proactively     collecting family history information from patients using computer technology independent of     a health care visit, including telephone (interactive voice response technology), tablet     computers in a physician's waiting room, and a secure internet portal at home. These tools     will be based on the US Surgeon General's My Family Health Portrait, an electronic family     history collection tool. Family history data will be transferred and integrated with a     patient's EHR in a large primary care network. This project will seek to demonstrate that     family history data can be accurately reported by diverse patients using these technologies,     and that these data can be integrated to tailor an individual's health care based on their     familial risk.   "
239097|NCT00977860|"     The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts,     the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity     observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free     Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at     2 years following hypofractionated stereotactic body radiation therapy for low and     intermediate risk prostate cancer.   "
239098|NCT00977873|"     The study null hypothesis is that vitamin D supplementation will not influence time to upper     respiratory tract infection or time to moderate/severe exacerbation of chronic obstructive     pulmonary disease.   "
239099|NCT00977886|"     The purpose of this trial is to study the safety and tolerability of repeated oral doses of     ELB353, to evaluate the plasma levels of ELB353 and to study their effect on substances     mediating inflammation.   "
239100|NCT00977899|"     Background:        -  Malaria, a disease transmitted by mosquitoes, affects millions of people with the          highest frequency, morbidity, and mortality in infants and young children. Plasmodium          falciparum and Plasmodium vivax, the most common and severe forms of malaria, have host-          and stage-specific proteins that can induce immunity to the disease.        -  Vaccines against stages that infect mosquitoes will prevent the spread of malaria.          Researchers have developed a vaccine composed of a single protein, Pfs25, to induce          antibodies in the human host that will be ingested by the mosquito and prevent the          malaria parasite from reproducing and stop transmission of the disease. Because Pfs25 is          present only in the mosquito, humans do not develop antibodies to this antigen even in          endemic areas. Repeated injections of this vaccine may be necessary.      Objectives:      - To establish the safety and optimal dosage of a malaria vaccine developed with the Pfs25     protein.      Eligibility:      - Healthy adults between 18 and 49 years of age who have never had malaria or received a     malaria vaccine.      Design:        -  Two doses of Pfs25 conjugate (10 micrograms and 25 micrograms) will be evaluated in this          study. Participants will receive only one of these doses in order to provide the best          scientific data for evaluation.        -  To determine eligibility, participants will provide a medical history and have a          physical examination, and will provide blood and urine samples to test for HIV/AIDS,          hepatitis, and other conditions that would prevent them from participating.        -  Eligible participants will receive one injection of the vaccine. The injection will be          followed 30 minutes later with a temperature reading and an inspection of the vaccine          site.        -  Upon leaving the clinic, participants will receive diary forms, a digital thermometer, a          ruler, and instructions about how to take their temperature and to measure redness and          swelling (if any) at the injection site. About 6 hours later, and daily for 3 days,          participants will take their temperature at home and examine the injection site.          Participants will be examined at the clinic at 48 to 72 hours and on day 7 after an          injection. A blood sample will be taken 1 week after immunization. - Participants will          receive a second and third injection of the same vaccine at 6-week intervals, and will          follow the same recording procedure given above. Further blood samples will be taken at          regular intervals for up to 12 months after the vaccination, as directed by the study          researchers.   "
239101|NCT00977912|"     The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence     of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.   "
239102|NCT00977925|"     The objective of this study is to evaluate the safety and hemostatic effectiveness of the     Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe     soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic     surgery.   "
239103|NCT00977938|"     The DAPT Study is a double blind randomized controlled trial intended to determine the     appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second     anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet     therapy to protect patients from stent thrombosis and major adverse cardiovascular and     cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents.     Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated     subjects.   "
239104|NCT00977951|"     The purpose of this study is to further determine the safety and toleration of intradermal     avotermin (Juvista), confirm accelerated healing and investigate genomic expression profiles   "
239105|NCT00977964|"     The primary objective of this study is to assess the comparative gastrointestinal (GI)     tolerance of normal term infants to six experimental milk protein-based powdered infant     formulas.   "
239106|NCT00977977|"     Background:        -  Membranous nephropathy is associated with damage to the walls of the glomeruli, the          small blood vessels in the kidneys that filter waste products from the blood. This          damage causes leakage of blood proteins into the urine and is associated with low blood          protein levels, high blood cholesterol values, and swelling of the legs. These problems          can decrease or go away without treatment in about 25 percent of patients, but if they          persist, some patients may experience impaired (or loss of) kidney function, blood          vessel and heart disease, and a risk of forming blood clots in veins.        -  Kidney biopsies that show that antibodies have been deposited along the glomeruli          suggest that specialized cells of the immune system, called B and T cells, are causing          damage to the kidneys through their increased activity. To suppress the action of B and          T cells and to decrease the harmful deposits in the kidneys, drug treatments are          required.        -  Patients with membranous nephropathy are often treated with immunosuppressive drugs such          as cyclosporine or cytoxan plus steroids that attempt to reduce or suppress the activity          of the immune system, decrease antibody production, and reduce antibody deposits in the          kidney. However, not everyone responds to these medications and the kidney disease can          return in some patients when the drugs are stopped. Also, there are side effects          associated with long term usage of these medications. Rituximab, a different          immunosuppressant, has also been used for this purpose. Although cyclosporine and          Rituximab have been used separately, they have not been tried in combination as a          possible treatment for membranous nephropathy.      Objectives:      - To determine the safety and effectiveness of combining rituximab and cyclosporine to treat     membranous nephropathy.      Eligibility:      - Individuals 18 years of age and older who have been diagnosed with membranous nephropathy     based on a kidney biopsy done within the preceding 24 months, and who have had excess levels     of protein in the urine for at least 6 months based on urine and blood tests.      Design:        -  Potential participants will be screened with an initial clinic evaluation and full          medical history.        -  Before the treatment, there will be a run-in period that will last up to 2 months.          During this time, participants will be placed on a blood pressure lowering medication          and will not take any other immunosuppressant medications.        -  Participants will visit the NIH clinical center for a baseline evaluation, four          intravenous infusions of rituximab, and also at 1- to 6-month intervals throughout the          study.        -  Active treatment period will involve a 6-month course of cyclosporine and a total of          four doses of rituximab. Participants will take cyclosporine tablets twice daily, and          have two infusions of rituximab given 2 weeks apart, After 6 months, the cyclosporine          dose will slowly be decreased over several weeks and then completely discontinued.          Participants will then receive another course (two doses 2 weeks apart) of rituximab,          depending on results of blood work.        -  Participants will have frequent blood and urine tests performed to monitor the results          of treatment and reduce the chance of side effects.   "
239107|NCT00977990|"     Background:        -  Polyomavirus are DNA-based viruses that infect vertebrates, including humans. Most          people are not harmed by polyomavirus infection, but people with compromised immune          systems may be harmed by these viruses, and are at greater risk for developing certain          types of rare cancers.        -  A recently discovered virus called Merkel cell polyomavirus (MCV) is a type of skin          infection commonly found in humans. By using skin swabs to collect MCV, researchers hope          to develop a laboratory culture model of MCV for future research.      Objectives:      - To use skin swabs to collect samples of Merkel cell polyomavirus for future study.      Eligibility:      - Individuals 18 years of age and older who are employed in the National Cancer Institute's     Laboratory of Cellular Oncology.      Design:        -  Participants will wipe a cotton swab across their forehead and eyebrows, and break off          the end of the swab into a microcentrifuge tube. This procedure will be performed after          work hours.        -  No other treatment or procedure will be given as part of this protocol.   "
239108|NCT00978003|"     Background:        -  Patellofemoral pain syndrome is one of the most common knee problems. It is          characterized by pain in the front of the knee that is aggravated by deep knee flexion,          prolonged sitting, and repetitive movement. The most widely accepted theory regarding          the source of this pain is that a force imbalance around the knee puts extra stress on          the area, leading to pain.        -  Researchers are interested in learning more about the muscle groups around the knee to          better understand the causes of knee pain.      Objectives:      - To obtain more information on how muscles, tendons, and bones work together to cause motion     in the knee, both in the normal state and after immobilizing certain muscles around the knee.      Eligibility:      - Healthy individuals between the ages of 18 and 55, who have no current or chronic muscle,     bone, or joint problems and who have no implants or other problems that would prevent them     from receiving a magnetic resonance imaging (MRI) scan.      Design:        -  This protocol will be carried out over two visits, both of which will involve using          standard MRI sequences to look at the knee at rest and in motion.        -  The first part will examine the knee under its natural state, with a standard MRI scan          of the knee both at rest and in motion.        -  The second part will involve temporarily reducing the force producing capabilities of          one of the extensor muscles in the knee. To do so, study doctors will inject lidocaine          into the muscle, which will temporarily (for approximately 2 hours) block the force          producing capacity of this muscle, and then perform the MRI scan.   "
239109|NCT00978016|"     The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (XP19986)     versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms despite     therapy with approved doses of a Proton Pump Inhibitor (PPI).   "
239110|NCT00978029|"     The purpose of this study was to assess the safety and tolerability of a ragweed allergy     immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years     of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.   "
239111|NCT00978042|"     Multicenter, single-blind, randomized, no-treatment control study to demonstrate the safety     and effectiveness of VOLUMA XC for deep injection for cheek augmentation to correct     age-related volume deficit in the mid-face.   "
239112|NCT00978055|"     The objective of this study was to investigate the bioequivalence of Mylan's liothyronine     sodium 50 mcg tablets to King's Cytomel® 50 mcg tablets following a single, oral 100 mcg (2 x     50 mcg) dose administration under fasting conditions.   "
239113|NCT00978068|"     HIV and malaria are major causes of morbidity and mortality in Sub-Saharan Africa and     children bear the greatest brunt of both diseases. No single existing intervention is likely     to control malaria in Africa. Rather, improvements in malaria prevention are likely to come     from strategies that employ multiple proven interventions targeting different populations.     HIV-infected children represent one of the most vulnerable subpopulations in these countries.     It is possible that the use of protease inhibitor (PI) - based antiretroviral therapy (ART)     in HIV-infected children living in areas of high malaria transmission could prevent malaria     in this vulnerable population. An effective remedy that offers the possibility to further     reduce malaria risk, such as PIs, is highly desirable. This study will determine whether a PI     based ART regimen will reduce malaria among children living in a malaria endemic area of     Uganda and receiving insecticide-treated bed nets (ITN) and TS. This study will compare two     different ART regimens. Children enrolled in the study will start or continue to receive     either standard Ugandan first line treatment ART regimen (NNRTI+2 NRTIs) or an ART regimen     containing the HIV protease inhibitor (lopinavir/ritonavir +2 NRTIs) and followed for a     period of 24 months.   "
239114|NCT00978081|"     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a     certain kind of light. When the drug is active, tumor cells are killed.      PURPOSE: This randomized phase I trial is studying the side effects and best dose of     photodynamic therapy in treating patients with premalignant or early stage head and neck     tumors.   "
239208|NCT00985413|"     This is an Observational Study of children under the age of 11 diagnosed with Cockayne     Syndrome to assess the natural progression of Cockayne Syndrome disease, with special     attention to hearing and physical changes in length or height, weight, head circumference,     and arm span during standard treatment.      The primary analytical objective is to determine the rate of linear growth over a 6-month     period in children < 2 years of age and over a 12-month period in children ≥ 2 years of age.   "
239115|NCT00978094|"     Primary hypotheses:      Ho1: In chronic neck pain patients, randomly treated with either a sham or real cervical     manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal     to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness     will remain unchanged following the treatment procedure for both groups.      Secondary (null) hypotheses:        1. Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will          remain unchanged in both groups;        2. there will be no differences between groups with respect to 2a) neck joint cavitations          and 2b) forces across the cervical spine measured during the manoeuvres.   "
239116|NCT00978107|"     This trial is a phase I, open-label, dose-escalating study of the safety or percutaneous     intra-tumoral injection of TG4023 (MVA-FCU1) combined with systemic administration of     5-fluorocytosine in patients with primary or secondary hepatic tumors.   "
239117|NCT00978120|"     The purpose of this study is to assess the safety and the body's immune response (body's     defense against disease) to an experimental H1N1 influenza vaccine in people with asthma. The     study will enroll 350, and possibly up to 400 healthy adults ages 12 and older with mild,     moderate, or severe asthma. Participants will be randomly assigned to 1 of 2 possible vaccine     groups: group 1 will receive 15 mcg of H1N1 vaccine; group 2 will receive 30 mcg of H1N1     vaccine given as two 15 mcg injections. Both groups will receive vaccine injections on days 0     and 21.      Study procedures include: medical history, physical exam, spirometry, maintaining a memory     aid and, and blood sample collection. Participants will be involved in study related     procedures for approximately 7 months.   "
239118|NCT00978133|"     2-octylcyanoacrylate (2-OCA) has been used extensively in clinical practice in trauma,     plastic surgery, orthopaedic surgery, emergency medicine and paediatrics. Most studies on     2-OCA to date have focused on closure of short wounds, and only one has included closure of     abdominal wounds in the context of general surgery. Here, the investigators will look at the     results of closure of abdominal wounds in patients undergoing elective colectomies with     2-OCA, which is commercially available to us, versus closure with skin staples, which is the     current standard technique of skin closure employed in the Department of Colorectal Surgery,     Singapore General Hospital. The primary objective was to measure effectiveness of 2-OCA in 2     respects - the adequacy of wound healing and cosmesis, and the incidence of superficial wound     infection.   "
239119|NCT00978146|"     The purpose of this study is to examine the response rate of desmoid tumors to hydroxyurea.     The investigators hypothesize that hydroxyurea will be a safe, non-toxic alternative to     aggressive surgery or chemotherapy for this difficult to treat tumor.   "
239120|NCT00978159|"     Aspirin can prevent ischemic vascular disease but is commonly complicated by dyspepsia in 30%     of patients. Patients, who have aspirin related dyspepsia, commonly underwent upper endoscopy     to exclude peptic ulcer disease or gastric cancers. For those without significant lesions in     the stomach and duodenum (non-ulcer dyspepsia), the best approach in the management is     unclear. The objective of this study is to compare the efficacy of esomeprazole and     famotidine in the control of dyspeptic symptom. After giving consent, patients will be     randomised to receive either esomeprazole 20 mg daily or famotidine 40 mg daily in a double     blinded manner. The patient will be followed-up at the 2nd and 4th week. The study will be     completed at the 4th week. The primary analysis will be the efficacy in the control of     dyspepsia symptom between the two groups.   "
239121|NCT00978172|"     The present study aims to investigate and to assess possible neurological and     neuropsychiatric events in young children in west Africa with uncomplicated P. falciparum     malaria after a 3-day treatment of Artequin Paediatric under real life conditions.   "
239122|NCT00978185|"     RATIONALE: Acupressure wristbands may prevent or reduce nausea caused by chemotherapy. It is     not yet known whether acupressure wristbands are more effective than standard care in     controlling acute and delayed nausea.      PURPOSE: This randomized phase III trial is studying acupressure wristbands to see how well     they work compared with standard care in controlling nausea caused by chemotherapy.   "
239123|NCT00978198|"     The purpose of the study is to evaluate the safety and tolerability of ASP1517 after single     or multiple oral administration in healthy non-elderly adult male subjects.   "
239124|NCT00978211|"     The investigators aim to explore the efficacy of [90Y-DOTA]-TOC and [177LuDOTA]-TOC therapy     in advanced neuroendocrine cancer. Therefore, the investigators assess response, survival and     long-term safety profile of systemic [90Y-DOTA]-TOC and [177LuDOTA]-TOC treatment in     metastasized neuroendocrine cancer patients. Adverse events are assessed according to the     criteria of the National Cancer Institute. Survival analyses are performed using multiple     regression models.   "
239125|NCT00978224|"     The purpose of the study is to determine whether Viusid administration improves malnutrition,     atherosclerosis, erythropoietin response and the frequency of infection episodes in subjects     with Chronic Inflammatory Syndrome under hemodialysis treatment. The duration of this     double-blind placebo controlled phase 3 clinical trial will be 60 weeks. All patients     enrolled in the study will be receiving the standard treatment for Chronic Inflammatory     Syndrome including hemodialysis and administration of a hypercaloric and hyperproteic diet.     Efficacy assessment will be carried out 12 weeks after the end of Viusid or placebo     treatment.   "
239126|NCT00978237|"     Eligible HIV-infected patients with clinically evident lipoatrophy despite treatment with     efavirenz and fixed-dose combination of thymidine nucleoside analogues will be informed and     asked to enroll in the study; will be randomized (1:1) into two branches, A: EFV + Fixed     combinations of analogue tenofovir + emtricitabine.B (experimental): LPV/r + combination of     correspondent analogues. The main variable is the evaluation of the absolute change in limb     fat mass at 24 months from baseline in both groups.   "
239165|NCT00978744|"     The Shared Health CHR™ (Clinical Health Record) offers point-of-care clinical reporting and     decision support based primarily on patient claims data aggregated across various health care     settings, and is one example of the types of health information data exchange efforts being     implemented across the country. This study will evaluate how the CHR is used and its clinical     and financial impact to better understand the CHR's value, and to identify opportunities to     enhance the system to support patient care and practice efficiency. In addition, the results     from this study will help to inform the national debate about the effectiveness of these     types of tools to maximize patient quality of care, patient safety, and practice efficiency.   "
239127|NCT00978250|"     Background:        -  Two experimental drugs, FdCyd (also called 5-fluoro-2'-deoxcytidine), and THU (also          called tetrahydrouridine), are undergoing trials to test their effectiveness in treating          cancer that has not responded to standard therapies. FdCyd is thought to work by          changing how genes work in cancer cells. THU does not have any anticancer effects on its          own, but it helps keep the other drug, FdCyd, from being broken down by the body.        -  These drugs are being tested on several separate clinical trials.      Objectives:        -  To determine if FdCyd and THU can work together to control tumor growth.        -  To evaluate the safety and tolerability of FdCyd and THU when given together.      Eligibility:      - Individuals 18 years of age and older who have advanced non-small cell lung cancer, breast     cancer, bladder cancer, or head or neck cancer that has progressed after receiving standard     treatment or for which no effective therapy exists.      Design:        -  The drugs are given over 28-day periods called cycles. FdCyd and THU are given through a          vein for about 3 hours each day on days 1 5 and 8 12 of each cycle.        -  Clinical Center visits: FdCyd and THU will be given through a vein each day on days 1 5          and 8 12 of each cycle. During the Clinical Center visits, researchers will perform          study tests and procedures to see how the study drugs are affecting the body.        -  Patients will undergo a number of tests and procedures during the treatment cycle,          including physical examinations, blood and urine samples for standard tests, imaging          studies (ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT) scans)          to evaluate tumor growth, and blood and urine samples to evaluate the amount of FdCyd          and THU in the body and the body's response to the drugs.        -  Patients may continue to receive FdCyd and THU if their cancer does not grow, if they do          not have too many side effects, and if they are willing to do so.   "
239128|NCT00978263|"     The investigators designed this prospective, randomized control study to compare the efficacy     and safety between the basal insulin glargine therapy and metformin-based OADs after     correction of the glucose toxicity with a short period of intensive insulin therapy.   "
239129|NCT00978276|"     The purpose of this study is the identification and classification of human tissues and     cytology specimens and elements therein.      Computer aided technology to assist the pathologists to identify, quantify, characterize and     report their findings with regards to one or more diagnoses they should perform. In     particular and for example: the scoring of the number of elements and their protein     (antibody) expression level within a paraffin embedded tissue section.   "
239130|NCT00978289|"     The purpose of this study is examine the relationship between adipose tissue inflammation and     activation of the endocannabinoid system before and after Roux-en-Y gastric bypass surgery.     The investigators hypothesize that the metabolic improvements and weight loss are due to     mechanisms that antagonize the endocannabinoid system.   "
239131|NCT00978302|"     The purpose of this study is to determine the safety and local toleration and histological     effects of various dose levels of avotermin (Juvista) injected intradermally in healthy male     volunteers.   "
239132|NCT00978315|"     The study null hypothesis is that vitamin D supplementation will not influence time to upper     respiratory tract infection or time to severe asthma exacerbation in adult and adolescent     patients with asthma.   "
239133|NCT00978328|"     The purpose of this study is to describe clinical and demographic characteristics of patients     receiving prescription medications containing oxycodone immediate release (OXYRX), to     characterize patient and prescriber perceptions of the effectiveness outcomes and     tolerability of OXYRX treatment, to describe prescriber decision-making about pain management     with a Schedule II opioid and to explore how prescribers identify suspected abuse of pain     medications.   "
239134|NCT00978341|"     The study is designed to assess if spinal cord injury patients have reduced pain after taking     either pregabalin or placebo in a cross over design. Patients had either pain at the level of     their injury or below the level of their injury.   "
239135|NCT00978354|"     Acute renal failure, now referred to as acute kidney injury, is common in intensive care unit     patients, contributes to high morbidity and mortality, and has no proven interventions with     benefit once established. In addition to supportive care, these patients frequently receive     diuretic therapy, most commonly furosemide.      Prior trials showed no impact of furosemide on clinical outcomes and perhaps harm, however,     these trials suffered from numerous limitations and lack applicability to modern intensive     care unit patients. As a result, there appears a disconnect between clinical practice and     available evidence. Survey data supports the view of clinical equipoise for use of furosemide     in intensive care unit patients with early acute kidney injury. Moreover, these data also     confirm there is an urgent need for higher quality and more definitive evidence from     randomized trial on furosemide use in early acute kidney injury.      Accordingly, the investigators propose to conduct a pilot phase II randomized, blinded,     placebo-controlled trial comparing furosemide to placebo in ICU patients with early acute     kidney injury.      The specific aims of this study are:        1. To compare the efficacy and safety of a continuous infusion of furosemide versus placebo          titrated to the physiology parameter of urine output in early acute kidney injury on the          primary outcome of progression in severity of kidney injury in intensive care unit          patients with early AKI and stratified by the presence of sepsis.        2. To evaluate selected secondary endpoints on the impact of furosemide versus placebo,          specifically: fluid balance goals; electrolyte and acid-base balance; the need for renal          replacement therapy (i.e. dialysis); total duration of acute kidney injury; the rate of          renal recovery; and mortality.        3. To compare the impact of furosemide versus placebo on the trajectory of serum and          urinary biomarkers (neutrophil gelatinase-associated lipocalin [NGAL], interleukin-18          [IL-18]) and evaluate whether these biomarkers perform superior to conventional measures          (creatinine, urea) for monitoring the progression of kidney injury and the prediction of          outcome.      This trial represents part of a larger initiative aimed towards expanding our understanding     of the treatment of acute kidney injury in intensive care unit patients and evaluating     interventions that may potentially reduce kidney injury and improve clinical outcomes.   "
239136|NCT00978367|"     The purpose of this study is to investigate the dosing frequency, wound healing     (re-epithelialisation) and anti-scarring effects of one, three and five applications of two     concentrations of intradermal RN1001 in healthy male subjects.   "
239137|NCT00978380|"     This trial is conducted in Asia, Europe and North America. The aim of the trial is to     investigate the safety of monthly replacement therapy of recombinant factor XIII in patients     with congenital FXIII deficiency. The trial continues until the product is commercially     available, but an interim assessment will take place when all subjects have completed 52     weeks in the trial.   "
239138|NCT00978393|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     effect of liraglutide on gastric emptying, energy expenditure and appetite, and to evaluate     liraglutide pharmacokinetics in non-diabetic obese volunteers. The trial is designed as a     two-period, six-sequenced, crossover trial where the trial participant will enter two     treatment periods with a wash-out period of 6-8 weeks.   "
239139|NCT00978406|"     Information about Americans food choices and opinions helps researchers and law makers to     develop policies and programs to promote health. For this reason, it is important to be able     to collect good quality information about how people think about food. This project will     compare different ways of collecting information about food from adults.   "
239166|NCT00978757|"     The purpose of this study is to determine whether ketamine is effective to inhibit     interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion.   "
239167|NCT00978770|"     RATIONALE: Diagnostic procedures such as MRI scans may help predict early response to     treatment in patients with breast cancer undergoing chemotherapy.      PURPOSE: This phase II trial is studying MRI in predicting early response to chemotherapy in     patients with locally advanced breast cancer.   "
239140|NCT00978419|"     This is a 90 day study, with patients receiving either oral Rosuvastatin or placebo for up to     28 days. The study will assess the affect of statins administered soon after burn injury on     C-reactive protein (CRP) levels, patient mortality and the incidence of septic shock. The     investigators also seek to describe the correlation between exposure to statins and     development of delirium and de-novo long-term cognitive impairment.      Hypothesis:        1. Statin administration within 96 hours of burn is safe, will decrease CRP, and will          decrease septic shock and mortality in burn patients.        2. The investigators hypothesize that burn patients will have a de-novo long term cognitive          impairment at 3 months after burn.        3. The investigators hypothesize the use of statins in burn patients will reduce the          development and the degree of cognitive impairment at 3 months post burn.   "
239141|NCT00978432|"     The purpose of this study is evaluate the response, safety and tolerability in subjects     receiving the investigational drugs, RAD001 and LBH589. Subjects in Part 1 will receive one     drug for four cycles followed by 4 cycles of the second drug unless they achieve complete     remission. Subjects in a complete remission may receive up to 6 cycles of study drug and will     not receive the next study drug until there is evidence of disease progression. Subjects in     Part 2 will receive both drugs together for at least 2 cycles and up to 13 if tolerated.   "
239142|NCT00978445|"     Long-term anticoagulation is indicated in patients for the prophylaxis and/or treatment of     the thromboembolic complications associated with atrial fibrillation and/or mechanical     cardiac valve replacement, prevention or treatment of venous thromboembolism (deep vein     thrombosis and pulmonary embolism), to prevent thromboembolic events post-myocardial     infarction, and in patients with systemic embolic events. Currently the only approved oral     medication for anticoagulation is warfarin (Coumadin, Bristol-Myers Squibb and generic     warfarin. Dosage is controlled by periodic determinations of the prothrombin time     (PT)/International Normalized Ratio (INR). Under treatment may lead to venous or arterial     thrombotic events or stroke, while over treatment may lead to major bleeding and even death.     Patients require frequent INR monitoring to maintain a therapeutic level of anticoagulation.     The therapeutic INR range varies by clinical indication, most commonly an INR 2-3 goal, but     ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of     4.0. The vMetrics - Anticoagulation Management System is a remote patient management solution     for Oral Anticoagulation Care patients. This system provides confirmation of patient question     and testing protocols as well as virtual patient management care capability for dosage and     patient scheduling. This trial will provide end points to ascertain efficiency against     standard care protocol and confirm equivalent care standards.   "
239143|NCT00978458|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more     tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. It is not yet known whether radiation therapy is     more effective when given together with or without temozolomide in treating patients with     low-grade glioma.      PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it     works when given together with or without temozolomide in treating patients with low-grade     glioma.   "
239144|NCT00978471|"     Approximately 150 new cases of osteosarcoma are reported each year in France, of which 15 to     20% are metastatic.      Further to the initial standard care, about 45% of the patients relapse within a median     duration of 20 months.      Result of the OS94 study results and of the investigation performed within the CRLCC,     indicate that 25 to 30 patients (children and adults) experience an osteosarcoma relapse each     year in FRANCE.      According to several studies, the 5-year overall survival rate of patients in first relapse     is 23-28%,with a median post relapse survival of 10 to 17 months. Multiple relapse cases are     also reported in the COSS study, with a median time to second relapse of 0.8 year.      At present, there is no reference treatment for the standard care of osteosarcoma relapse in     FRANCE.      Thiotepa is known for its antitumor effect in numerous malignant tumors. In 2007, a study     from our institution reported that about 35% of all osteosarcoma relapses are treated with a     high-dose thiotepa while the efficacy and tolerance of this therapeutic strategy have never     been assessed.      These results highlight the need to the evaluate the efficacy and tolerance of this high-dose     of thiotepa within a clinical trial and its inclusion in the standard care of the     osteosarcoma at relapse.   "
239145|NCT00978484|"     Therapy that uses Virtual Reality (VR) has been shown to help in the treatment of Post     Traumatic Stress Disorder (PTSD). It is unclear what role the VR simulator itself plays in     recovery. This study is examining if full-immersion in VR causes greater improvement in PTSD     symptoms than does similar therapy that uses a simple, static, computer image.   "
239146|NCT00978497|"     The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598     when administered with pegylated interferon and ribavirin (Standard of Care [SOC]) compared     to placebo + SOC.   "
239147|NCT00978510|"     The purpose of this study is to evaluate in hospital environment the knowledge of the health     care professionals about fundamental concepts on tuberculosis and the accomplishment to     respiratory isolation practices for patients with pulmonary tuberculosis hospitalized in a     public hospital in Fortaleza, Ceará, Brazil.   "
239148|NCT00978523|"     The primary objective of this study in adults with advanced or recurrent solid tumors or     lymphoma is to evaluate the safety and tolerability of AR-12 by describing dose-limiting     toxicities (DLTs), and thereby establishing the maximum tolerated dose (MTD) or, in the     absence of reaching an MTD, a recommended dose (RD) for additional study of oral AR-12     administered daily in cycles of 28 days (28 consecutive days of once daily treatment with at     least a 7-day break between the first and second treatment cycles and recovery of toxicity to     grade 1 or less, with no planned off-treatment days between subsequent cycles).   "
239195|NCT00979160|"     This is a multicenter, open-label, single arm phase II non-randomized study of dasatinib in     which subjects with systemic mastocytosis (SM) will be treated with a continuous regimen of     dasatinib.      Upon completion of a treatment induction period, subjects will be treated with dasatinib at a     dose of 100 mg per os (OS) once daily (QD).   "
239149|NCT00978536|"     In multiple sclerosis (MS) sub cortical cognitive impairments are frequently reported.     Nevertheless, cortical cognitive troubles, with hippocampic memory troubles have been     described. Besides inflammatory damage, early cortical and degenerative damage are well     known. In neurodegenerative diseases, three biomarkers of the cerebro spinal fluid (CSF),     reflecting lesional mechanisms, are measured: the beta amyloid peptide, the tau total     protein, and the phospho tau protein. Preliminary studies shown increased level of tau in MS.     No study compare cognitive impairment and biomarkers of CSF.The aim of this study is to     measure in the CSF of MS patients these three biomarkers (beta amyloid peptide, tau total and     phosphotau) in order to establish correlations between a profile of biomarkers and a pattern     of cognitive troubles, cortical or subcortical.The possibility to show, in MS patients with     memory hippocampic troubles, a profile of biomarkers closed from the one encountered in AD,     could argue in support of the degenerative hypothesis in MS and lead to discuss the interest     of the use of AD treatment in MS.   "
239150|NCT00978549|"     RATIONALE: Analgesics, antiemetics, steroids, and radiation therapy are effective in helping     to control symptoms caused by cancer. It is not yet known whether these treatments are more     effective when given with or without docetaxel in treating patients with relapsed esophageal     cancer or stomach cancer.      PURPOSE: This randomized phase II trial is studying symptom control given together with     docetaxel to see how well it works compared with symptom control given without docetaxel in     treating patients with relapsed esophageal cancer or stomach cancer.   "
239151|NCT00978562|"     This clinical trial studies dynamic susceptibility-weighted contrast enhanced magnetic     resonance imaging (DSC-MRI) after administration of ferumoxytol and dynamic contrast-enhanced     MRI (DCE-MRI) after administration of a gadolinium-based contrast agent (GBCA) in viewing the     vessels of the brain in younger patients with brain tumors. Ferumoxytol is an experimental     form of very small iron particles that are taken by the blood stream to cells adjacent and     inside the tumor. These iron particles may make it easier to see the areas of the brain that     are affected by tumor. Ferumoxytol may work better than standard GBCA in viewing the vessels     of the brain and brain tumor on MRI. Using ferumoxytol and GBCA in the same MRI session may     provide more information about tumor blood supply and the extent of the tumor.   "
239152|NCT00978575|"     The trial is a double-blind randomized trial designed to examine whether compliant iron     therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more     and faster than no treatment - in patients with acute bleeding from upper gastrointestinal     tract. The trial will include 126 patients at Aarhus University Hospital. In addition to     efficacy assessment quality of life assessment and health economic calculations between the     treatments will be compared.   "
239153|NCT00978588|"     Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for     cardiopulmonary bypass   "
239154|NCT00978601|"     The purpose of this study is to evaluate a multimodal analgesic protocol used in minimally     invasive surgery for myomectomies (laparoscopic myomectomy (LM) and laparoscopically assisted     myomectomy (LAM)).   "
239155|NCT00978614|"     Primary:        -  To assess the effects of ascending repeated-doses of oral [p.o.] neramexane at          therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc          interval) in healthy male and female subjects.      Secondary:        -  To assess the pharmacokinetics [PK] of neramexane and N-OH neramexane (if a validated          method will be available for this metabolite) following repeated daily doses of 50 mg          (steady state), 75 mg (steady state) and 87.5 mg (steady state).        -  To assess the safety and tolerability of neramexane 50 mg, 62.5 mg, 75 mg and 87.5 mg          repeated-dose treatments when gradually up-titrated in healthy subjects.        -  To assess the concentration-QT relationship.   "
239156|NCT00978627|"     This trial is conducted in Europe, Oceania, and the United States of America (USA).      The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart     (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes     (main period) followed by the extension period comparing the long-term safety of NN5401 plus     insulin aspart with insulin detemir plus insulin aspart.      The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension     period is registered as NN5401-3645.   "
239157|NCT00978640|"     Hypothesis: during fasting and exercise will there be an activation of sirtuins (Sirt1).      Primarily the investigators will investigate Sirt1 activity in muscle- and fat-biopsies after     fasting for 36 hours and after 1 hour of ergometer-cycling at 50 Vo2max.      In addition to this the investigators will investigate the effect of fasting and exercise on     the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.   "
239158|NCT00978653|"     In this prospective study, the investigators aimed to evaluate the effects of improved     hyperuricemia, a minor cardiovascular risk factor, on endothelial dysfunction in patients     with chronic kidney disease.   "
239159|NCT00978666|"     The purpose of this study is to use fMRI imaging technology to examine areas in the brain     related to appetite, reward and cognition in adolescent women with eating disorders as     compared to those who have never had an eating disorder. Better understanding biologic     vulnerabilities in women with anorexia is essential for developing more effective treatment     options.   "
239160|NCT00978679|"     The primary objective of the current study is to investigate changes in peripheral refraction     and aberration in children wearing orthokeratology lenses and single-vision spectacles.   "
239161|NCT00978692|"     The aims of this study are to investigate the effects of ortho-k for astigmatic and myopic     reduction and myopic control in children, and the long term effects on corneal curvatures and     biomechanics.   "
239162|NCT00978705|"     The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.   "
239163|NCT00978718|"     RATIONALE: Selenium supplements may stop or delay the development of prostate cancer in     patients at high risk of prostate cancer. It is not yet known which dose of selenium may be     more effective in preventing prostate cancer.      PURPOSE: This randomized phase III trial is studying how well selenium works in preventing     prostate cancer.   "
239164|NCT00978731|"     To determine the long term safety and tolerability of dasatinib exposure in subjects     previously treated in CA180-002.   "
239168|NCT00978783|"     Background:      Many patients with respiratory failure related to neuromuscular disease receive chronic     invasive ventilation through a tracheostomy. Improving quality of life, of which speech is an     important component, is a major goal in these patients. The investigators compared the     effects on breathing and speech of low-level positive end-expiratory pressure (PEEP, 5 cm     H2O) and of a Passy-Muir speaking valve (PMV) during assist-control ventilation.      Methods:      Flow will be measured using a pneumotachograph. Microphone speech recordings were subjected     to both quantitative measurements and qualitative assessments; these last consisted of a     perceptual score and an intelligibility score determined by two speech therapists using a     French adaptation of the Frenchay Dysarthria Assessment.   "
239169|NCT00978796|"     The purpose of this study is to determine the effects of sitagliptin on glucose variability     both after meals and overnight in adult patients with type 1 diabetes.   "
239170|NCT00978809|"     The propose of this study is to compare two methods of physical treatment for benign     paroxysmal positional vertigo, by evaluating treatment effects on postural stability.      The trail design is a double blinded randomized controlled trail, with each patient going     through three evaluations: before treatment, 1 week after treatment and 60 days after     treatment.   "
239171|NCT00978822|"     This study is designed to assess how rapidly and how safely Clevidipine can be used to     control high Blood Pressure in patients with subarachnoid hemorrhage which is a type of brain     bleed that happens because of a weak balloon like structure in one of the brain vessels.     Control of blood pressure is of high value in preventing this balloon that ruptured and bled     from rebleeding. The ultimate cure would be to shut down the aneurysm by a surgical     procedure. Clevidipine is a drug that can lower blood pressure and it is given through the     vein as a continuous infusion. It is a very short acting drug which is important in     controlling labile blood pressure condition with rapid changes between up and down. This     trial will test for its rapid actions and check for any side effects and possibly any other     potential benefit.   "
239172|NCT00978835|"     Diabetes and hypertension co-exist in approximately 10 million people in the USA and     constitute severe risk factors for the development of such complications as heart and kidney     disease. The investigators propose a randomized controlled trial in patients of community     primary care practices to study a tailored telephone-administered behavioral intervention to     improve control of blood pressure and blood sugar in patients with both hypertension and     diabetes. The investigators hypothesize that 20% more patients talking to a nurse every other     month about ways to improve blood pressure and blood sugar control will bring their blood     pressure under control when compared to patients who talk with the nurse only about general     health issues. If successful in improving control of these diseases this intervention can     easily be adopted in other community primary care practices to lessen the burden of diabetes     and hypertension in the USA.   "
239173|NCT00978848|"     The purpose of this study is to determine the prevalence and treatment rates of T. vaginalis,     C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine     pregnancy testing in the Magee-Womens Hospital outpatient clinic using a non-invasive urine     STD test.   "
239174|NCT00978861|"     The purpose of this study is to determine the effect of REMEWHITE on tooth whitening.   "
239175|NCT00978874|"     RATIONALE: Diagnostic procedures, such as fluorine F 18 EF5 PET/CT imaging, may help find     oxygen in tumor cells. It may also help doctors predict a patient's response to treatment and     help plan the best treatment.      PURPOSE: This phase I trial is studying fluorine F 18 EF5 PET/CT imaging to see how well it     works in finding hypoxia in tumor cells of patients with locally advanced or     recurrent/metastatic cervical cancer.   "
239176|NCT00978887|"     The purpose of the study is to assess the efficacy of Retorna facial cream usage in the     reduction or total correction of facial wrinkles. The duration of this double-blind placebo     controlled phase 3 clinical trial will be 4 weeks. The estimated number of women to be     recruited and randomized for the study is 148. Occurrence of adverse effects will also be     evaluated.   "
239177|NCT00978900|"     The purpose of this study is to examine the influence of artificial sweeteners (aspartame,     acesulfame K, sucralose) and carbohydrate sugars (glucose, fructose) on the release of     gastrointestinal satiety hormones in humans.   "
239178|NCT00978913|"     The primary aim of this study is to evaluate the toxicity of the vaccine and the combination     of the vaccine and Cyclophosphamide, and to evaluate the immune response induced by the     vaccine. The secondary aim is to investigate the clinical tumour response and duration of     tumour and immune response.   "
239179|NCT00978926|"     The well-established role of vascular endothelial growth factor (VEGF) in carcinogenesis and     tumor angiogenesis has led to the development of agents that target this pathway. Anti-VEGF     agents the VEGF monoclonal antibody bevacizumab, and the small molecule VEGF receptor     tyrosine kinase inhibitors. Angiogenic factors play a key role in the maintenance of lung     integrity and normal endothelial function. Endothelial dysfunction has been implicated in     hypertension, proteinuria and retinopathy. One of the major issues of anti-VEGF agents is its     long-term toxicity especially taking into account the lack of adequate knowledge in this area     and the possibility of prolonged periods of therapy in non-progressing patients. Hypertension     and proteinuria are commonly seen in patients treated with anti-VEGF agents. In addition, the     investigators have also observed in a relatively high frequency of pulmonary air-filled     lesions in patients with malignancy in the lung treated with an anti-VEGF agent. Objectives     of this exploratory study are to 1) determine the effect of anti-vascular endothelial growth     factor (VEGF) on endothelial function 2) determine endothelial dysfunction as a marker of     early response and as an indicator for the development of hypertension and proteinuria 3)     characterize the effect of anti-VEGF therapy on the pulmonary function of patients with     malignancy (primary or secondary) involving the lung in patients treated with anti-VEGF     agents. Pharmacodynamic endpoints to be assessed are: blood pressure, brachial artery     reactivity, retinal microvessels, microalbuminuria and proteinuria, pulmonary function,     assess the effects of anti-VEGF therapy by assessing brachial artery reactivity, retinal     vasculature and pulmonary function in a subset of patients receiving anti-VEGF therapy. The     development of markers of endothelial dysfunction may result in the early identification of     patients who are non-responders or develop toxicity from anti-VEGF treatment.   "
239180|NCT00978939|"     Purpose and Objective: The purpose of this study is to determine if the rate of spontaneous     pleurodesis using the Pleurx® catheter could be increased by simply increasing the frequency     of pleural drainage and, if so, whether catheter-related complications can be minimized and     spare patients the need for long term management of the Pleurx® catheter.   "
239181|NCT00978952|"     This study is designed as a prospective, multicenter, non-randomized, single arm study to     assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for     stent implantation in coarctations of the aorta.   "
239209|NCT00985426|"     The purpose of the study is to explore the safety and immunogenicity of a new investigational     hepatitis B virus vaccine, HEPLISAV™, in patients 18 to 75 years of age who have progressive     loss of kidney function.   "
239182|NCT00978965|"     This study is designed to define groups of patients (among patients with a heart or kidney     graft or a glomerular disease and nephrotic range proteinuria) who would either not profit     from a therapy with mycophenolate-mofetil (MMF) or need a higher than conventional dose to     respond.      Mainly there are 2 possible explanations for inter-patient differences in responsiveness to     MMF therapy:        1. Based on a mutation (in this study single nucleotide polymorphisms-SNPs-) in the inosine          monophosphate dehydrogenase 2 (IMPDH 2) transcript as the target enzyme of mycophenolic          acid (MPA) pathway, MMF cannot exert its effect.        2. Based on a high enzyme activity of IMPDH 2 a higher MMF dose than in the conventional          regimens is needed.      To study the significance of these possible explanations there are 4 objectives in this     study:      Objective 1: Since there are no data on SNPs with functional relevance in IMPDH 2 transcript,     we will first sequence all 14 exons of this gene in their entirety in 100 gender and age     matched healthy individuals.      Objective 2: The functional relevance of a detected SNP will be tested in vitro in a     lymphocyte proliferation assay using various MPA concentrations.      Objective 3: These functionally relevant SNPs will be searched in patients with kidney graft     in a retrospective as well as prospective manner.      Objective 4: Parallel to the genotyping experiments, IMPDH 2 activity and MPA plasma levels     will be measured in all patients recruited in the study prospectively.      An association between these SNPs or various IMPDH 2 activity / MPA plasma levels with MMF     responsiveness will be examined.   "
239183|NCT00978978|"     Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional     sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with     liver diseases. The investigators' working hypothesis is that the use of propofol will be     translated in a shorter recovery and discharge times with a higher patient satisfaction and a     decrease in general complications in the context of patients with advanced liver disease.   "
239184|NCT00978991|"     The proposed project is aimed to build a Duke University-specific longitudinal urologic     surgery database. It will be used as the main resource to support future research within     Urology and Duke University.   "
239185|NCT00979004|"     Subjects with epilepsy with a documented photoparoxysmal response to intermittent photic     stimulation (IPS) will participate. Four subjects will be enrolled at each dose level and     will receive a single dose of placebo and a single dose of ICA-105665 during the study, each     followed by intermittent photic stimulation. The effects of ICA-105665 on the photoparoxysmal     electroencephalography (EEG) response of each group will be reviewed before the dose is     selected for each subsequent group of subjects.   "
239186|NCT00979017|"     The primary objective of the study is to determine the efficacy of Avastin in combination     with temozolomide and irinotecan in terms of response rate. The secondary objectives are to     describe the overall and progression-free survivals of unresectable patients treated with     upfront Avastin, temozolomide and irinotecan and to assess the safety of Avastin,     temozolomide and irinotecan in unresectable glioblastoma patients.      This is a phase II study with the combination of Avastin, temozolomide and irinotecan for     unresectable or multifocal World Health Organization (WHO) grade IV malignant glioma     patients. Patients will receive up to four cycles of Avastin, temozolomide and irinotecan.     Approximately 41 subjects will take part in this study at Duke.   "
239187|NCT00979043|"     The primary purpose of this study was to determine the effect of dietary weight-loss,     exercise training, or a combination of both on physical function in overweight and obese     adults with knee osteoarthritis (OA). In secondary analyses, the effect of weight-loss and/or     exercise on OA progression, self-reported pain and inflammation were examined. In post-trial     analyses, the effect of dietary weight-loss on total mortality was determined.   "
239188|NCT00979056|"     The aim of the study is to investigate the efficacy of the prophylactic treatment with     rifaximin to prevent travellers diarrhoea.   "
239189|NCT00979069|"     The purpose of this study is to see if exercise can improve brain function in older adults   "
239190|NCT00979095|"     The investigators are performing a genetic study of patients with multiple hernias (at least     3 primary hernias) versus a healthy control group. This genetic information is compared with     circulating and subcutaneously biomarkers such as matrix-metalloproteinases (MMP's).      The hypothesis is that patients with multiple hernias have different expression of specific     genes compared to the healthy control group.   "
239191|NCT00979108|"     The purpose of this study is to determine the effectiveness of adding mechanical traction to     standard physical therapy treatments for patients with neck and arm pain.   "
239192|NCT00979121|"     Objective: assess the efficacy and safety of oral rosuvastatin in patients with     sepsis-induced Acute Lung Injury (ALI).      Hypothesis: Rosuvastatin therapy will improve mortality in patients with sepsis-induced ALI.   "
239193|NCT00979134|"     This study is primarily designed to assess the safety and tolerability of AZD4547 at     increasing doses in patients with advanced solid malignancies and for whom no standard     medication options are available. It also assesses the blood levels and action of AZD4547 in     the body over a period of time.   "
239194|NCT00979147|"     This study is designed to compare prospectively, in a randomized Level 1 evidence fashion,     the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray     with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT)     design with GVF polyethylene. Comparing these two designs will afford us information in the     following areas:        1. Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF          design?        2. Is there a clear clinical advantage to the MPT/XLK design in certain patient populations          that justify its use over the APT/GVF design?      Answering these questions will allow surgeons to use both designs appropriately in different     demand populations.      This study is designed to address the questions of whether an MPT/XLK design offers     improvement in wear characteristics, Knee Society scores, KOOS, WOMAC, SF-36, or radiographic     measures, over an APT design. The investigator's primary hypothesis is that there will be no     difference in these outcome measures at a minimum two year follow-up. A secondary hypothesis     based on the long-term follow-up of this group, up to twenty years, is that there will be no     difference in implant survival.   "
239210|NCT00985439|"     The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are     safe and effective for the treatment of dental pain.   "
239196|NCT00979173|"     The primary objective is to evaluate the intratumoral and plasma pharmacokinetics of AC480     among patients who are candidates for a resection with a recurrent malignant glioma who are     not on CYP-3A enzyme inducing anti-epileptic drugs (EIAEDS). Secondary objectives include the     following: to evaluate the antiproliferative effect of AC480 by FDG-PET Scan; to evaluate the     safety and tolerability of AC480; and, to describe 6-month progression-free survival (PFS)     and radiographic response.      This is a single institution, open label, pharmacokinetic study of AC480 in patients with     recurrent malignant glioma. The study will enroll 5 patients who are not on enzyme inducing     anti-epileptic drugs (EIAEDs) and are scheduled to undergo salvage surgical resection for     preoperative treatment with AC480 at 300 mg orally twice daily (BID) for 14 (plus or minus 2)     days before surgery (Part I- Induction Therapy). After surgery (Part II- Maintenance     Therapy), patients will continue to be dosed with AC480 until disease progression or     intolerance, and will be evaluated after every other cycle (1 cycle is 28 days).   "
239197|NCT00979186|"     The study will document being able to successfully perform transgastric cholecystectomy     (laparoscopic visualization) using a small collection of study surgical tools.   "
239198|NCT00979199|"     Main purpose of the study:      To comparatively assess the diagnostic performance of non invasive anatomical and functional     imaging modalities to detect significant obstructive coronary artery disease as demonstrated     at invasive coronary angiography and functional evaluation of coronary lesions (fractional     flow reserve).   "
239199|NCT00979212|"     RATIONALE: Drugs used in chemotherapy (CT), such as paclitaxel and carboplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy (RT) uses high-energy x-rays to kill tumor cells.     Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Giving these treatments before surgery may     make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is     not yet known whether chemotherapy and radiation therapy are more effective when given with     or without panitumumab in treating patients with non-small cell lung cancer.      PURPOSE: This randomized phase II trial is studying chemotherapy and radiation therapy to see     how well they work when given with or without panitumumab in treating patients with stage     IIIA non-small cell lung cancer.   "
239200|NCT00979225|"     This three-year, grant funded project will be conducted by the Division of Clinical     Informatics in the Department of Community and Family Medicine at Duke University Medical     Center. The project seeks to improve care quality and safety in an ambulatory care setting     through clinical decision support for evidence-based (EB) pharmacotherapy delivered as     point-of-care reports to clinic-based practitioners and as population health-based alerts to     care managers.      This project will build upon a regional Health Information Exchange (HIE) network created to     connect providers serving 37,000 Medicaid beneficiaries from both rural and urban settings in     a 5 county region in the Northern Piedmont of North Carolina. This network includes 16     private practices, 3 federally qualified health centers, 5 rural health centers, 3 urgent     care facilities, 10 government agencies, 5 hospitals, and 2 cross-disciplinary care     management teams.      The proposed information system will be based on an emerging standard for decision support     and will utilize routinely available claims and scheduling data in order to serve as a     replicable model for broader use of decision support for medication management. Increased     availability and use of decision support tools for medication management can be expected to     reduce medication errors, improve health care quality at an acceptable cost, and augment     disease management for patients and populations.   "
239201|NCT00979238|"     The purpose of this study is to determine the safety of giving a normal factor IX gene to     treat individuals who have an abnormal or no factor IX gene. Recruitment will be limited to     adults (≥ 18 years) with a confirmed diagnosis of hemophilia B (HB), resulting from a     missense mutation in the coagulation factor IX (FIX) gene or a nonsense mutation that has not     been associated with an inhibitor. Only subjects who have no evidence of active hepatitis or     anti-hFIX antibodies, and who have been treated/exposed to Factor IX concentrates for at     least ten years and have had an average of 3 bleeding episodes per year requiring FIX     administration will be enrolled. Patients will be recruited within the United States for     treatment at St. Jude Children's Research Hospital, and patients will be recruited in England     and other countries for treatment in London by our British collaborators.   "
239202|NCT00979251|"     This Phase 2, open label, randomized study will investigate the virologic benefit, clinical     efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus     oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised     adult and pediatric subjects.   "
239203|NCT00985348|"     To demonstrate the bioequivalence of a Levetiracetam dry syrup (50% (500mg/1000mg)) versus     Levetiracetam 500 mg oral tablet, used as reference, after single dose administration in     healthy Japanese subjects.   "
239204|NCT00985361|"     The purpose of this study is to determine if daily supplementation with 2000 International     Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics.   "
239205|NCT00985374|"     This 2 part study will assess the safety, tolerability and efficacy of a combination of oral     daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1     of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001     daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po     RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with     1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive     the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507).     The anticipated time on study treatment is until disease progression, and the target sample     size is 100-500 individuals.   "
239206|NCT00985387|"     The purpose of the study is to assess patient's persistency in maintaining solifenacin     treatment for overactive bladder.   "
239207|NCT00985400|"     The goal of this study is to compare the effects of exercise with the effects of relaxation     training on physical function (how well participants perform normal daily activities) and     symptoms related to your cancer diagnosis (such as tiredness, pain, and nausea).   "
239211|NCT00985452|"     The investigators hypothesize that providing subjects on a once-a-day hypertension medication     with GlowCaps ConnectTM will lead to an improvement in their medication adherence. The     investigators propose to conduct a 6-month randomized control trial to assess the effect of     the GlowCaps Connect™ system on the enhancement of hypertension medication adherence among     subjects with a diagnosis of hypertension recruited from the greater Boston area. 130     subjects will be enrolled. Subjects will be randomized into either the control group or into     one of two intervention groups.   "
239212|NCT00985465|"     The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK     Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster     dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects     previously enrolled in the primary vaccination study NCT00678301.      This protocol posting deals with objectives & outcome measures of the booster phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT00678301).   "
239213|NCT00985478|"     First in man study with single and multiple rising doses with SLV342   "
239214|NCT00985491|"     The purpose of this study is to determine whether the GI Endobarrier Liner is safe and     effective.   "
239215|NCT00985504|"     The purpose of this study is to provide a comparison of the apathy, depression, and     functional outcomes associated with switching to duloxetine or escitalopram in patients who     have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI)     for major depressive disorder and who have residual apathy in the absence of depressed mood.   "
239216|NCT00985517|"     The purpose of this study is to evaluate the safety and potential benefits of CERE-120 in the     treatment of Parkinson's disease. CERE-120 is an experimental drug that consists of an     adeno-associated virus (AAV) that was engineered to carry the human gene for neurturin, a     neurotrophic (growth) factor. Similar to other growth factors (such as GDNF), neurturin is     capable of restoring function and protecting brain cells from further damage. The virus used     in CERE-120 is not known to cause disease in people.      CERE-120 is delivered directly to the brain cells most affected in Parkinson's disease - the     dopamine producing neurons. CERE-120 is injected during brain surgery. Once in place,     CERE-120 continuously produces neurturin.   "
239217|NCT00985530|"     Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial     treatment or has not gone away with initial therapy. This research study involves testing an     investigational drug called Tamibarotene in combination with standard treatment for relapsed     APL called arsenic trioxide. Tamibarotene has been approved in Japan to treat patients with     relapsed APL since April 2005. Tamibarotene is in the same family of drugs as all-trans     retinoic acid (ATRA), a medication that subjects received previously in their treatment. ATRA     and tamibarotene both cause the APL cells to differentiate (or become) normal non-leukemia     cells. Laboratory studies of tamibarotene have shown to be effective in APL. The purpose of     this study is to determine if tamibarotene in combination with arsenic trioxide is safe and     effective.   "
239218|NCT00985543|"     The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir     over a 12-hour dosing interval, following administration to male and female HIV−negative     healthy volunteers of:        1. Lopinavir/ritonavir 400/100 mg twice daily        2. Lopinavir/ritonavir 200/150 mg twice daily        3. Lopinavir/ritonavir 200/50 mg twice daily   "
239219|NCT00985556|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, S-1, and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells. It is not yet known whether giving oxaliplatin together with S-1 is more effective     than giving oxaliplatin together with capecitabine.      PURPOSE: This randomized phase II trial is studying how well giving oxaliplatin together with     S-1 works compared to oxaliplatin given together with capecitabine in treating patients with     recurrent, metastatic, or unresectable gastric cancer.   "
239220|NCT00985569|"     The purpose is to assess the efficacy, clinical outcomes, and potential Quality Indicator     benefits associated with the use of Lubiprostone in nursing home residents with a confirmed     diagnosis of chronic idiopathic constipation.   "
239221|NCT00985582|"     The aims of this study are to characterise the clinical efficacy and virological clearance     dynamics of orally administered oseltamivir in patients with influenza caused by novel     influenza A(H1N1). This research will also contribute to enhancing research capacity in     affected countries.      The objectives are to assess the:        -  viral replication levels over time in affected patients        -  antiviral efficacy of oral oseltamivir        -  patterns and compartments of viral shedding, tissue distribution        -  innate inflammatory response and relation to viral replication        -  kinetics of antibody response        -  antiviral sensitivity of influenza viruses at baseline and during oseltamivir treatment          using in vitro and molecular methods        -  pharmacokinetic characteristics of oseltamivir and oseltamivir carboxylate        -  all cause in hospital mortality        -  clinical and radiological features, disease course and outcome        -  length of stay in hospital        -  risk factors associated with development of severe disease and death   "
239222|NCT00985595|"     The objective of the study is to test the effectiveness, implementation quality, and cost     effectiveness of family-based treatment services for adolescent substance abuse delivered in     an agency setting.   "
239241|NCT00986258|"     The main objective of the study is to evaluate the effectiveness, tolerability, and safety of     tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back     pain (LBP) who are taking WHO Step III analgesics and show lack of tolerability. This is a     clinical effectiveness trial designed to establish a link between anticipated clinical     outcomes and the clinical practice by means of selected measures of clinical and     subject-reported outcome.      The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with     that of tapentadol hydrochloride prolonged release treatment during defined periods of     evaluation.   "
239242|NCT00986271|"     To investigate whether extravascular lung water index (EVLI) is an independent predictor for     multiorgan dysfunction syndrome (MODS) in patients with severe sepsis and to determine if     increased EVLI may serve as an predictor for MODS and mortality in those patients.   "
239243|NCT00986284|"     This study aims to investigate the efficacy and safety of gefitinib as neoadjuvant therapy in     stage IIIA NSCLC patients.   "
239223|NCT00985608|"     H pylori gastric infection is one of the most prevalent infectious diseases worldwide. The     discovery that most upper gastrointestinal diseases are related to H pylori infection and     therefore can be treated with antibiotics is an important medical advance. Currently, a     first-line triple therapy based on proton pump inhibitor (PPI) or ranitidine bismuth citrate     (RBC) plus two antibiotics (clarithromycin and amoxicillin or nitroimidazole) is recommended     by all consensus conferences and guidelines. Even with the correct use of this drug     combination, infection can not be eradicated in up to 23% of patients. Therefore, several     second line therapies have been recommended. A 7 d quadruple therapy based on PPI, bismuth,     tetracycline and metronidazole is the more frequently accepted. However, with second-line     therapy, bacterial eradication may fail in up to 40% of cases. When H pylori eradication is     strictly indicated the choice of further treatment is controversial. When available,     endoscopy with culture and consequent antibiotic susceptibility testing remains the most     appropriate option for patients with two eradication failures to avoid a widespread use of     expensive antibiotics. The use of these drugs may also induce severe side-effects and     development of H pylori resistant strains.      Resistant strains of Helicobacter pylori can display a dense biofilm with mucus and     microorganisms in a coccoid shape on the mucosal surface of stomach that may have a role in     determining the resistance to the antibiotic therapies. Possibly, N-acetil-cysteine (NAC) may     dissolve biofilm architecture and help to eradicate resistant strains of H pylori.   "
239224|NCT00985621|"     The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared     to oxycodone CR and placebo in patients with osteoarthritis   "
239225|NCT00985634|"     The primary purpose of this study is to demonstrate the clinical safety and efficacy of     LeGoo™ in comparison to a standard vessel occlusion method (i.e. vessel loops). Although     LeGoo™ is suitable for use in any vascular surgery where temporary vessel occlusion is     desired, this study specifically focuses on the use of LeGoo™ in off-pump coronary bypass     (OPCAB), as a most sensitive model of adverse changes that may occur at any vascular site.   "
239226|NCT00985647|"     The purpose of the study is to measure the pharmacokinetics (how a drug is absorbed,     distributed and eliminated from the body) of lamivudine (3TC) and its active component after     3TC is given at two different doses, 300mg and 150mg once daily.   "
239227|NCT00985660|"     The objective of this study was to investigate the bioequivalence of nisoldipine     extended-release 30 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release     30 mg tablet (manufactured for First Horizon) following a single, oral 30 mg (1 × 30 mg     tablet) dose administration in healthy adult subjects under fasting conditions.   "
239228|NCT00985673|"     The purpose of this study is to characterize the safety and immunogenicity of the H1N1     (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu     vaccine in adults 19 to 40 years of age.   "
239229|NCT00986102|"     The purpose of this study is to understand the utilization patterns of doripenem in Asia     Pacific, including the profile of the patients treated with carbapenems.   "
239230|NCT00986115|"     People with epilepsy often experience problems with their memories and other thinking skills     that get worse over time. The investigators hope to learn more about whether a drug called     memantine can help improve or stabilize (keep the same) memory and other thought processes in     people with epilepsy by blocking a chemical that is released in the brain during seizures.     The investigators also want to see if memantine changes the frequency (how often) people with     epilepsy have seizures. Memantine is currently approved by the United States Food and Drug     Administration (FDA) for treatment of patients with Alzheimer's disease.   "
239231|NCT00986128|"     The purpose of this study is to determine the initial (after 1-week of maintenance dosing)     and extended (after 3-weeks of maintenance dosing) effect of topiramate, at doses up to 600     mg/day, on the steady-state pharmacokinetics (absorption, distribution and excretion of the     drug by the body) of lithium carbonate in patients with bipolar disorders.   "
239232|NCT00986141|"     Primary objective is to evaluate the effect of selective laser trabeculoplasty (SLT) on the     diurnal intraocular pressure variation in open-angle glaucoma patients (OAG).   "
239233|NCT00986154|"     Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing     recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the     legs and/or blood clots in the lungs.   "
239234|NCT00986167|"     This study is a multi-site study examining the use of Quetiapine XR for psychotic aggression     in an acute psychiatric setting. The study aims to demonstrate that management with     Quetiapine XR significantly reduces aggressive behaviour in acute patients with psychosis,     significantly reduces psychotic symptoms and decreases the requirement for sedation using     benzodiazepines.   "
239235|NCT00986180|"     Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the     treatment of acute low back pain.   "
239236|NCT00986193|"     This study is a randomised comparison of apical stent valve treatment versus conventional     valve surgery in patients with severe aortic valve stenosis.   "
239237|NCT00986206|"     RATIONALE: Screening tests, such as the lysophosphatidic acid assay, may help doctors find     cancer cells early and plan better treatment for ovarian cancer.      PURPOSE: This clinical trial is studying using the lysophosphatidic acid assay to see how     well it works in early detection of ovarian cancer in patients with ovarian cancer or who are     at risk for ovarian cancer.   "
239238|NCT00986219|"     The purpose of the study is to evaluate the concordance of the most frequently used words by     the patients and the physicians to express asthma symptoms and the limitations of daily     activities caused by asthma.   "
239239|NCT00986232|"     A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II     and PUVV (Process Upgrade Varicella Vaccine) vaccines.   "
239240|NCT00986245|"     1. In order to compare the benefit, side effects, and patient preference of Ropinirole          prolonged release when used in once-daily or twice-daily dosing        2. In order to estimate the conversion rate of dopamine agonists into Ropinirole prolonged          release   "
239259|NCT00986505|"     The effect of intravenous lidocaine infusion on manifestations of fibromyalgia manifestations     were recorded before and 4 weeks after treatment. Pain intensity was rated on a numerical     scale.The combination of 240 mg intravenous lidocaine (once a week) and 25 mg amitriptyline     for 4 weeks did not modify pain intensity or manifestations in patients with fibromyalgia.   "
239245|NCT00986310|"     The purpose of this study is to determine the effects of fluoxetine on breathing mechanisms     during seizures. Patients with partial epilepsy commonly have changes in their breathing     mechanisms during seizures. These changes may increase the risk of serious side effects from     seizures, including sudden unexplained death in epilepsy (SUDEP), which affects 2-10 per 1000     patients with epilepsy each year. Fluoxetine (Prozac) may help to stimulate breathing through     its actions in the brain and has been shown to improve breathing changes seen with seizures     in certain animals. Fluoxetine is in a class of medications called selective serotonin     reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural     substance in the brain, at synapses, the junctions at which nerve cells in the brain     communicate. Fluoxetine is currently approved by the United States Food and Drug     Administration (FDA) for the treatment of patients with Major Depressive Disorder, Obsessive     Compulsive Disorder, Bulimia Nervosa, Panic Disorder and Premenstrual Dysphoric Disorder.   "
239246|NCT00986323|"     The purpose of this study is to determine whether nocturnal environmental control with     Temperature controlled Laminar Airflow (TLA) is effective as add on treatment in patients     with perennial allergic asthma.   "
239247|NCT00986336|"     The purpose of this study is to assess the potential pharmacokinetic (absorption,     distribution and excretion of the drug by the body) interaction between, and the safety of,     topiramate and risperidone administered in combination in patients with a history of either     bipolar spectrum or schizoaffective (bipolar type) disorders as defined by DSM-IV criteria.   "
239248|NCT00986349|"     The main objective of the study is to demonstrate the safety and efficacy of the     Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2     diabetes.   "
239249|NCT00986362|"     To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to     conventional vitrectomy for the treatment of pediatric patients.   "
239250|NCT00986375|"     The purpose of this study is to help Internet users to adopt and maintain a healthy     lifestyle, it is imperative to increase self-management competencies to improve healthy     eating and regular physical activity. Aim of this research project is to evaluate an     evidence- and theory-based computerized expert system in comparison to a standard program. In     addition, two different tailoring criteria are compared to each other with regard to the     misclassification of study participants. Internet users will be treated psychologically and     followed up over 12 weeks. The computerized expert system is expected to help users better     than the standard program. Both interventions are hypothesized to improve self-management     competencies over time.   "
239251|NCT00986401|"     The purpose of this study is to investigate the safety and tolerability of trospium chloride     (Sanctura XR™) and metformin hydrochloride (Glucophage) when co-administered.   "
239252|NCT00986414|"     This phase IIb study is designed to determine the safe and efficacious dose or dose range of     AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa     induced dyskinesias.   "
239253|NCT00986427|"     This purpose of this study is to assess the safety and effectiveness of Restasis® ophthalmic     emulsion versus emulsion alone( Refresh Dry Eye therapy) both for the treatment of brittle     nails and for the enhancement of normal nail growth and texture. The investigators think that     daily application of Restasis® to nails and nail beds in patients with brittle nails will     enhance nail growth and improve nail texture in both affected and unaffected nails.   "
239254|NCT00986440|"     Monotherapy treatment with CS-7017 to assess progression-free-survival (PFS) of subjects who     achieved an objective response of Disease Control on first line therapy with Folinic acid     (leucovorin), Fluorouracil (5-FU), Oxaliplatin (Eloxatin) known as FOLFOX; or Folinic acid     (leucovorin), Fluorouracil (5-FU), irinotecan (Camptosar) known as FOLFIRI.   "
239255|NCT00986453|"     The objective of this clinical study is to evaluate the operative performance of the PEAK     PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain,     adverse events and skin scarring following surgery; and compare these outcomes to the current     standard of care (SOC).   "
239256|NCT00986466|"     The aim of the study is to investigate the effects of exercise and vitamin D supplementation     on reducing falls and injuries in community-dwelling, independent-living women aged 70-79     years of age. The investigators will test the following hypothesis:        1. Exercise including strength, balance and mobility training will improve muscle          functioning and body balance, and thus reduce falls by 30% compared with non-exercisers.        2. Vitamin D intake will improve muscle functioning and thus prevent falls by 30% compared          with placebo.        3. Together vitamin D and exercise have a stronger influence on fall prevention than either          used alone.        4. Training improves mobility functions and bone health.        5. Supervised training twice a week with daily home training will improve physical          functioning thus resulting in reduced fear of falling.        6. Reduced fear of falling and improved physical functioning help older people to stay          physically active, which further improve their quality of life.   "
239257|NCT00986479|"     The purpose of this study is to determine the antidepressant effects of AZD6765 compared to     placebo.   "
239258|NCT00986492|"     Evidence that shortened period of sleep could be a risk factor for weight gain and obesity     has grown over the past decade. Concurrent with the obesity epidemic, numerous studies have     reported a parallel epidemic of chronic sleep deprivation. Sleep is important in maintaining     energy balance (i.e. acute sleep deprivation impact the normal secretion of ghrelin and     decreases leptin plasma levels). Surprisingly, in humans, there is no direct evidence that a     shortened night has direct effect on energy metabolism during the following day.      This study is set up to determine whether a partial sleep deprivation night has an impact on     appetite and food energy intake and, concomitantly, on physical activity, during the     following day.   "
239274|NCT00986713|"     The purpose of this study is to determine whether inhalation with aerosolized amphoterin B     10mg/d is more effective than aerosolized amphoterin B 2mg/d to reduce the incidence of     invasive pulmonary aspergillosis.   "
239432|NCT00982436|"     The purpose of this study is to evaluate the effectiveness and safety of neoadjuvant     chemotherapy (chemotherapy given before radiotherapy) using cisplatin and docetaxel, followed     by carboplatin given at the same time as radiotherapy in the treatment of locally advanced     head and neck cancer.   "
239260|NCT00986518|"     T regulatory lymphocytes were shown to be partly responsible for immune tolerance to cancer     cells. In that respect these cells oppose to the mounting of an efficacious immune response     needed to cure cancer. To treat advanced metastatic colorectal cancer, the investigators     propose an immunotherapy consisting in autologous lymphocytes infusion depleted from     T-regulatory cells, associated with a 5-day prior lymphoid-ablative chemotherapy associating     cyclophosphamide (day 1 & 2) with fludarabine (day 1 to 5). To administer treatment and     monitor chemotherapy safety, patients will be hospitalized for 3 weeks until complete     recovery from chemotherapy. Patients will then be followed-up ambulatory for 9 months during     which time they will be assessed for tumor size with computed tomography (CT) - scan (primary     criteria).   "
239261|NCT00986531|"     The purpose of this study is to assess if AZD8529 improves performance on neurobehavioral     probes of attention, working memory and affective reactivity in patients with schizophrenia.   "
239262|NCT00986544|"     The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.   "
239263|NCT00986557|"     RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce     cytomegalovirus infection during the first year after a donor stem cell transplant.      PURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it     works compared with standard therapy in treating patients at risk of cytomegalovirus     infection after a donor stem cell transplant.   "
239264|NCT00986570|"     The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe,     effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or     severe expression lines (wrinkles) in the upper third of the face. The main outcome was the     change in appearance of the wrinkles two weeks (visit 3) after product application as     compared with baseline assessment.   "
239265|NCT00986583|"     Based on available mechanistic and clinical information, the investigators propose a     nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The     investigators' purpose is to evaluate the effect of succinylcholine on patients taking     statins. Patients scheduled to undergo elective surgery (other then orthopedic, spinal,     vascular or muscle) with planned endotracheal intubation will be approached regarding     participation in the trial. Design of the study is complex because there is no way to     randomize patients to statins or no statins and also no way to take them off the statins     prior surgery. So statin use will not be randomized; confounding factors will be accounted     for by stratification (every 10 years of age from 40-80 and gender) and statistical     adjustment. The investigators propose to test the hypothesis that succinylcholine     administration increases plasma myoglobin concentration more in patients who are on statins     compared to patients who do not.   "
239266|NCT00986596|"     The purpose of the study is to investigate the effect of vitamin D on muscle tissue and     physical performance.   "
239267|NCT00986609|"     RATIONALE:      Vaccines made from peptides may help the body build an effective immune response to kill     tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or     delay the recurrence of cancer.      PURPOSE:      To evaluate the efficacy of poly-ICLC + MUCI peptide vaccine in boosting the immunologic     response to MUCI in patients with triple-negative BC   "
239268|NCT00986635|"     Rivaroxaban represent a new class of anticoagulation agents. As an oral direct factor Xa     inhibitor it has been effective in preventing venous thromboembolism in patients undergoing     elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo     effects of Xarelto® on different coagulation parameters.   "
239269|NCT00986648|"     The PALF study group began with 20 sites and now continues with 12 sites (11 in the United     States and 1 in Canada) in the new funding period. The primary objective of the Pediatric     Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical,     epidemiological, and outcome data in children with ALF, including information derived from     biospecimens.   "
239270|NCT00986661|"     This open-label study will evaluate the safety, tolerability, pharmacokinetics and effect on     tumor growth following a single intralesional injection of PV-10 in subjects with either (a)     hepatocellular carcinoma (HCC) that is not amenable to resection, transplant or other     potentially curative therapy or (b) cancer metastatic to the liver.   "
239271|NCT00986674|"     This randomized phase II trial is studying how well giving carboplatin and paclitaxel     together with cetuximab and/or cixutumumab (IMC-A12) works in treating patients with stage     IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin     and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and     cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Giving chemotherapy together with monoclonal antibody therapy may kill     more tumor cells. It is not yet known whether carboplatin and paclitaxel are more effective     when given with cetuximab and/or cixutumumab in treating non-small cell lung cancer.   "
239272|NCT00986687|"     Vitrification is a method to cryopreserve biological specimens that are sensitive to chilling     injury such as oocytes and embryos, and it has been employed with increased survival rate and     live births (Hong et al., 1999; Kuleshova et al., 1999; Yoon et al., 2000; Chung et al 2000;     Wu et al., 2001: Kuwayama et al 2006). In their study the researchers propose to directly     compare oocyte survival, fertilizaton and embryo development between sibling oocytes.      The Cryotop method of vitrification, which the researchers aim to investigate in their study,     has been reported as the most efficient method for human oocytes cryopreservation (Kuwayama     et al, 2005, Antinori et al, 2006, Lucena et al, 2006, Cobo et al, 2008). Follow up of over     200 infants conceived from vitrified oocytes (Chian et al, 2008) indicate that the mean birth     weight and the incidence of congenital anomalies are comparable to that of spontaneous     conceptions in fertile women or infertile women undergoing IVF treatment.   "
239273|NCT00986700|"     High fasting glucose is a very common problem in type 2 diabetic patients. The cause is     probably glucose production by the liver, known as the dawn phenomenon. The investigators     hypothesize that a late night meal can lower the fasting glucose level by early morning     insulin secretion stimulated by the food. In this study the investigators intend to test the     effect of different kinds of late night meals on fasting glucose in type 2 diabetic patients.   "
239277|NCT00986765|"     Preeclampsia (PE) complicates 2-8% of pregnancies. It is associated with an increased risk of     adverse maternal (death, eclampsia, abruptio placenta, HELLP syndrome) and perinatal     (perinatal death, growth restriction, prematurity) outcomes. The only definite treatment of     PE remains pregnancy termination. Therefore, prevention of PE remains an important challenge.     Low dose aspirin may be used in the prevention of PE, particularly in women who had a severe     preeclampsia before 34 weeks. Its efficiency, however, is very weak. Recently, it has been     suggested that low molecular weight heparin might be useful in the prevention of PE.      The aim of this study is to analyze the usefulness of the enoxaparin 4000 UI/day in the     prevention of a composite maternal or perinatal morbidity (occurrence of one of the following     events: maternal death, PE, fetal growth retardation, abruptio placenta, perinatal death) in     women who previously had a severe preeclampsia at less than 34 weeks' gestation. To answer     this question, the investigators propose to conduct a multicenter prospective randomized     trial that will compare two groups in parallel: a group where women will have an association     of enoxaparin 4000 U/day and aspirin 100 mg/day and another group where women would have only     aspirin 100 mg/day. The number of patients needed is 255 (amendment n°2-approved 06/12/2011)     .   "
239278|NCT00986778|"     Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity     compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in     Chinese adults with lamivudine-resistant chronic hepatitis B infection   "
239279|NCT00986791|"     Hazardous alcohol intake is an independent risk factor for postoperative complications after     major and minor operations, elective and emergency procedures for men and women.      The aim of this study is to evaluate the effect of a 6-week Gold Standard Programme for     alcohol cessation intervention in the perioperative period compared to the daily routine     guidelines for patients with hazardous alcohol intake undergoing ankle fracture surgery.   "
239280|NCT00986804|"     Primary:      To determine the maximum tolerated dose and schedule of decitabine when administered as     maintenance therapy after allogeneic hematopoietic stem cell transplantation (alloHSCT)     performed for AML or high-risk MDS.   "
239281|NCT00986817|"     Ascites is a common complication of cirrhosis. Sodium restriction and diuretics are the first     step treatment. Refractory ascites (not responding to first step treatment) is treated with     repeated large volume paracentesis followed by intra venous albumin expansion. In pilot     studies vasoconstrictor agents such as terlipressin have shown beneficial effect on ascites     production. Therefore the investigators will study the effect of combined therapy with     albumin and terlipressin on recidivation ascites.   "
239282|NCT00986830|"     A prospective, non-randomized trial to evaluate post-operative health care resource     utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the     physician's office.   "
239283|NCT00986843|"     The main objective of this study is to determine the maximum tolerated dose (MTD) of     OratecanTM. Eligible subjects of this study are patients with histologically or cytologically     confirmed malignant solid tumor refractory to standard therapy.      The irinotecan hydrochloric acid (HCl) tablet is escalated and administered per body surface     area (BSA). The dose of HM30181A 60 mg is fixed.      The Route of administration of irinitecan and HM30181A is oral. Each cycle consists of 21     days. Drugs are administered daily for 10 consecutive days (D1, 2, 3, 4, 5, 8, 9, 10, 11 and     12) followed by a washout of 9 days.   "
239284|NCT00986856|"     To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment     of impetigo in paediatric patients.      To assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a     prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin®     cream.      To investigate the genetic relationship between S. aureus-strains isolated from impetigo     patients.   "
239285|NCT00986869|"     Background      Flexible bronchoscopy (FB) is one of the most common invasive procedures performed by     pulmonologists (1) . Typically performed under topical anesthesia and conscious sedation, the     procedure is considered to be safe, effective and well tolerated in patients with a wide     variety of pulmonary diseases (2). Complications associated with the procedure are rare and     studies have estimated an incidence of 0.5-4% (3) The most commonly recognized complications     include hypoxia, bleeding, bronchospasm, cardiac dysrhythmias, pneumothorax, and vagal     reactions (4). Several conditions increase the risk of complications including pre-existent     hypoxemia, use of mechanical ventilation, uremia, profound thrombocytopenia, coagulopathy and     pulmonary hypertension (PH) (5). Although previous reports suggest that transbronchial     biopsies increase the risk for hemorrhage in this population, data are is limited to survey     analyses and isolated reports. Recently Guzman et al. reported a retrospective analysis about     the safety of FB in PH. (6) They found that FB can be performed safely in patients with mild     and moderate PH. However, the study was small and retrospective analysis. Furthermore, there     is no consensus regarding levels of pulmonary artery pressure (PAP) considered to be safe for     invasive diagnostic interventions such as TBLB or transbronchial needle aspiration.      Objective      To assess the safety of FB in patients with PH and to study the occurrence of complications     associated with different diagnostic bronchoscopic procedures.   "
239286|NCT00986882|"     The study will assess the analgesic efficacy and safety and tolerability of a single oral     dose of SAF312 in postoperative dental pain patients after 3rd molar extraction.   "
239287|NCT00986895|"     The purpose of this study is to determine the safety and tolerability of GT4P administered     orally as a single dose, and twice daily for 7 consecutive days, to subjects with hepatic     impairment with cirrhosis (Child-Pugh scores of A, B, or C) and to a gender matched and     similar age control group with normal hepatic function.   "
239288|NCT00986921|"     Women who are requesting pregnancy termination at 14-16 weeks, who would normally have     osmotic dilator insertion the day before their procedure, would be asked if they wanted to     participate. Participants would be randomized to two groups: first, dilator insertion as     usual, or second, mifepristone taken the day before the procedure.   "
239344|NCT00987662|"     Objective:        1. To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory          blood pressure values in obese subjects        2. To study the drug specific effect in arterial stiffness        3. To study possible drug mechanisms in obesity (reduction of central adiposity and          changing the ratio of leptin to adiponectin)   "
239289|NCT00986947|"     Some patients who need kidney transplants have high levels of antibodies that make them     incompatible with most potential deceased donor kidney offers. These patients are considered     highly-sensitized and are very difficult to transplant because the likelihood that they will     receive a compatible organ is very low. There are some medications and procedures that can     decrease the antibody levels and this can increase the chance of finding a compatible donor     for these patients. In this study the investigators will give two medications (IVIg and     Rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor     kidney transplant. After the investigators administer these medications, the investigators     will continue to check for compatibility as organ offers are received. If a compatible organ     offer is received, the investigators will perform the transplant using that organ. The     investigators hypothesize that these medications will lower antibody levels and increase the     chance that a these patients are able to receive a compatible kidney transplant.   "
239290|NCT00986960|"     The purpose of this study is to evaluate whether the use of ACTH in addition to Avonex is     effective in the treatment of relapsing remitting multiple sclerosis.   "
239291|NCT00986973|"     The aim of this pilot study is to determine if there are any changes in brain glucose     metabolism in the gray matter of patients with Phenylketonuria (PKU) and whether     administration of Sapropterin (KUVAN) therapy can improve such deficits.   "
239292|NCT00986986|"     This study is a pilot study examining the effect of extended-release niacin (Niaspan ®) on     flow-mediated vasodilation (FMD) of the brachial artery, among human immunodeficiency virus     (HIV)-1 infected individuals with low high density lipoprotein (HDL). Brachial artery     diameter will be measured by high-resolution ultrasound at entry and week 12 of study. The     primary comparisons will be change in FMD from baseline to 12 weeks within each of the two     arms. The second specific aim will be to investigate the proportion of the effect of     extended-release niacin on other known cardiovascular markers.   "
239293|NCT00986999|"     Rosuvastatin belongs to a class of medications commonly called statins which are     medications given for high low density lipoprotein (LDL) 'bad' cholesterol to prevent     atherosclerosis (hardening of blood vessels) and lower risk of heart attacks and other     circulation problems. Recent studies in the general non-HIV infected population have shown     that the beneficial effect of statins in preventing circulation problems is larger than would     be expected from lowering of LDL-cholesterol alone. It has been suggested that the additional     beneficial effect of statins may be due to the anti-inflammatory effect of statins.      The risk of heart attacks and other circulation problems may be high in HIV infected     individuals. This may be due to the inflammatory stress effects of HIV. The main purpose of     the study is to see if rosuvastatin will have a beneficial effect on the circulatory system     in HIV infected individuals even in those who do not have high LDL cholesterol levels.     Therefore, in HIV-infected individuals with normal or low LDL cholesterol levels but with     evidence of low HDL cholesterol levels which may be a sign of low grade inflammation, the     study will look at whether 3 months of rosuvastatin will lead to improvement in brachial     artery flow-mediated dilatation (FMD), a marker of early atherosclerosis (hardening of the     blood vessels).   "
239294|NCT00987012|"     It has been shown in laboratory studies that pomegranate juice contains anti-viral action     against influenza. The researchers wish to investigate the effect of pomegranate juice on     patients suffering from influenza A (seasonal or swine flu).   "
239295|NCT00987025|"     The purpose of TEAhM is to determine if telehealth blood pressure stations can be installed     and used in senior nutrition centers and to do a preliminary comparison of blood pressure     outcomes among nutrition center clients who use the telehealth blood pressure stations     compared to participants who do not use the stations. Specifically, the goals of the project     are to determine if these monitors can be successfully implemented in this community-based     setting, the degree to which older adults with hypertension are comfortable using the     technology, and whether remote nurse monitoring of blood pressure using this technology is a     feasible supplement to office-based care.   "
239296|NCT00987038|"     The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on     the blood levels (pharmacokinetics) of midazolam   "
239297|NCT00987051|"     The purpose of this study is to investigate the relevance of sentinel node in endometrial     cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women     with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is     questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an     alternative to complete lymphadenectomy.   "
239298|NCT00987064|"     The purpose of this study is to determine whether clean air administered to the breathing     zone with Temperature controlled Laminar Airflow (TLA) during night is effective in the     treatment of perennial allergic asthma.   "
239299|NCT00987077|"     The purpose of this study is to evaluate the efficacy of Selective Retina Therapy (SRT) for     treating acute idiopathic central serous chorioretinopathy (ICSC). Patients with acute     symptomatic ICSC of at least 3 months duration were recruited. The patients were randomized     by equal terms to SRT- (Treatment) and control group. After 3 months follow up patients of     control group with persistence of disease activity were allocated to crossover group and     received either SRT. Crossover group was followed up for further 3 months.      The primary outcome measure of the study are the serial changes in Early Treatment of     Diabetic Retinopathy Study (ETDRS) letterscore and edema in optical coherence tomography     (OCT) at 3 months. Secondary outcome measures included the proportion of eyes with complete     absorption of subretinal fluid, leakage in fluorescein angiography and the systemic and     ocular complications during the study at 3 months.   "
239321|NCT00987363|"     The aim of the study is to evaluate the safety and feasibility of autologous bone marrow     mononuclear cells autologous administered intra-arterially in the affected limb of diabetic     patients with chronic critical ischemia of the lower limbs (CLI) without possibility of     revascularization or other therapeutic alternatives.      The trial hypothesis we propose consists of mononuclear cells of bone marrow providing     progenitor cells with regenerative capacity and secrete also several angiogenic factors, and     their implantation into ischemic tissues with both elements should contribute to angiogenesis     and tissue regeneration with recovery of the circulation in the affected limb   "
239300|NCT00987090|"     Alzheimer's disease (AD) is usually associated with aging, age being the principal identified     risk factor. However, younger subjects also develop AD and the prevalence of early onset AD     is unknown. It is estimated that about 30 000 subjects develop symptoms of AD before the age     of 65 in France. There is evidence that early onset AD differs from AD in older patients. In     particular, clinical and neuroimaging studies suggest early involvement of neocortical brain     regions and their functions in early onset AD, while mediotemporal areas and memory might be     more involved in late onset AD. These differences could partly explain the atypical clinical     and imaging features of younger patients, the diagnostic difficulties in these patients and     the specific problems related to medical care of this age group. The present study uses a     multidisciplinary approach with longitudinal followup in order to establish the impact of age     on the clinical and neuroimaging picture of sporadic AD in a multicentric setting. Another     aim of the project is to describe for each age group, and in particular for the younger     patient group, the functional impact of disability in everyday life on both, patients and     caregivers.   "
239301|NCT00987103|"     The purpose of this study is to investigate the pharmacokinetics of rectal and sublingual     administration of tacrolimus and to compare with pharmacokinetics after oral administration     of tacrolimus in renal transplant patients before transplantation.   "
239302|NCT00987116|"     Pathology - Generalized myasthenia gravis (MG) is cause of muscle weakness that can have a     significant impact on daily life activity but can also be, when respiratory or bulbar muscles     are involved, life-threatening.      Rationale - Additionally to thymectomy, which indication of is still debated in absence of     thymoma, the long-term treatment of generalized myasthenia gravis includes usually prednisone     and azathioprine. However, the most used scheme for prescribing and tapering corticosteroid     in MG resulted in a very important cumulative dose of prednisone. Indeed, at twelve month,     more than 50 percent of patients are still daily treated with at least 18 mg of prednisone     and the proportion of patients who are in remission and no longer taking prednisone is very     low (Palace and NEWSOM Davis, Neurology 1998). Prolonged corticosteroid therapy is     accompanied with various and major side effects, hypertension, osteoporosis, weight gain,     glaucoma. Therefore, tapering, eventually discontinuing, prednisone earlier is a relevant     therapeutic goal.      For this reason, the investigators will compare to the standard one, a strategy consisting of     a rapid decrease in corticosteroid.      Objective - To assess whether, in patients with generalized MG requiring a long-term     treatment with corticosteroids and azathioprine, that the strategy of rapid tapering allows     discontinuing more rapidly the prednisone for equivalent efficacy than the classical     strategy.   "
239303|NCT00987129|"     Docosahexaenoic acid (DHA) supplementation has been shown to prevent specific age-related     changes in the retina through biochemical and functional evaluations, but it is unclear     whether increased DHA intake-reflected through elevated DHA+EPA blood levels-can affect the     natural history and progression of age-related macular degeneration (AMD). AMD is a disease     affecting the macula, the part of the eye containing cone photoreceptors at the center of the     visual field. The macula is responsible for vision in most daily functions, including     reading, seeing fine details, and colour recognition. Severe AMD can lead to a central     scotoma, severely impairing daily functioning. AMD can be divided into two forms: the more     severe wet AMD, consisting of proliferation of new blood vessels in the retina, and dry AMD     characterized by the development of drusen, a buildup of extracellular material . The     investigators are focused on the group with the highest risk of developing the two advanced     forms of AMD [wet AMD or central geographic atrophy]: patients with unilateral wet AMD and     dry AMD in their other eye. The study will consist of following up a cohort of such subjects     and monitoring their visual function in a comprehensive manner. Working in concert with     clinical ophthalmologists and basic scientists, the investigators will monitor DHA+EPA and     Omega6:Omega3 fatty acid ratio levels in the blood, inherited predispositions through     genetic analysis, lipofuscin (an accumulated waste product) levels & AMD progression via     fundus photography, visual acuity, and retinal function via full-field and multifocal     electroretinograms. These different factors will be cross-correlated and evaluated to     determine how omega-3 fatty acids affect the progression of AMD.   "
239304|NCT00987142|"     A phase II, comparative, open label, prospective, multicentre clinical trial where each     patient will undergo two procedures; implant of a patch of cultured chimeric skin     (experimental therapy) in a half of the skin lesion and an occlusive non-adherent dressing     (control) in the other half for 12 months of follow-up in two Spanish centres.   "
239305|NCT00987155|"     1. Measurements of peak oxygen uptake (VO2peak) during passive leg cycling (PLC) combined          with arm crank ergometry (ACE), leg vascular occlusion (100mmHg above systolic BP)          combined with ACE, and FES isometric contractions combined with ACE in spinal cord          injured (SCI). All the above mentioned parameters will be compared to Functional          Electrical Stimulated (FES) lower extremity cycling combined with ACE (FEShybrid). The          hypothesis is that VO2peak is significantly higher during FES hybrid cycling when          compared to peak and submaximal PLC, leg vascular occlusion and ACE. But the values for          VO2peak during FES isometric contractions combined with ACE is not significantly          different from FES hybrid cycling.        2. Comparison of sub-maximal and peak VO2 values during arm crank (ACE) and wheelchair          ergometry (WCE) in persons with spinal cord injury. The hypothesis is that wheelchair          propulsion due to higher energy expenditure show higher work output and VO2peak than          ACE.        3. Does 6 weeks of maximal strength training improve SCI subjects performance during WCE?          WCE after 6 weeks maximal strength training is less strenuous owing to better work          economy/ efficiency.        4. Effect from aerobic high intensity hybrid training on stroke volume (SV) and VO2peak in          spinal cord injured men.      8 weeks of high intensity 4 times 4 interval training at 85-90% of peak heart rate during     hybrid cycling. Hypothesis; VO2peak and SV will be significantly increased from training.   "
239306|NCT00987168|"     To replace Sandostatine® in three daily subcutaneous injections by a single intramuscular     injection of Sandostatine® LP per month in patients with a diffuse form of hyperinsulinism.   "
239345|NCT00987675|"     RATIONALE: High-intensity focused ultrasound ablation uses high-energy sound waves to kill     tumor cells.      PURPOSE: This phase II trial is studying the side effects of high-intensity focused     ultrasound ablation and to see how well it works in treating patients with progressive     prostate cancer.   "
239307|NCT00987181|"     Reduced aortic stiffness is a powerful way to predict the outcome of cardiovascular (CV)     disease. There are several non invasive methods for its estimation, most of which are based     on the measurement of speed of the arterial pulse wave. (The stiffer the artery, the faster     the pulse wave travels.) They rely on detecting the arterial pulse with 2 sensors placed on     the skin a known distance apart and measuring the time for the pulse to travel between them.     However all current methods require skilled operators and are of limited accuracy. Thus,     there is a need for an easy to use and reliable device to measure pulse speed. The aim of     this project is to develop a non contact device to detect the aortic pulse as it moves into     the small arteries following the ribs, using the principle of thermal imaging, by means of a     high sensitivity infra red camera, directed towards the subjects back. The investigators plan     to validate the device and conduct a small feasibility study in patients undergoing elective     angiography, by simultaneously measuring pulse speed using established methods. These are     Doppler ultrasound (non-invasive) and direct intra-arterial measurement (the gold standard).   "
239308|NCT00987194|"     Background Recently, the CDC issued recommendations calling for HIV screening for patients     aged 13-64, when the individual accesses the health care system. For many patients, the     emergency department (ED) is the primary or only contact point for health care. The rapid HIV     test can be done as a point of care test in the ED.      Study Objectives      A. Primary:      1. To initiate HIV testing in the Baystate ED.      B. Secondary:        1. To estimate the resources involved in initiating a rapid HIV testing program in the ED.        2. To describe the process of initiating a rapid HIV testing program.        3. To compare the yield of testing for HIV in patients with known HIV risk factors compared          to those without known risk factors.        4. To describe the characteristics of the population tested for HIV in the ED.        5. To determine the number of patients who declined testing and the reasons for declining          testing.        6. To analyze ED staff attitudes re: HIV rapid testing in the ED.      Methods A trained HIV Educator/counselor will approach patients in the ED to offer free rapid     HIV testing, at a time they are not currently engaged with the health care provider. Study     informed consent and HIV consent will be obtained prior to testing. The HIV educator will     obtain demographic and clinical information on the enrolled subjects including prior HIV     testing and HIV risk factors. Patients testing negative will be counseled regarding HIV risk     reduction strategies. Patients with an initial positive rapid HIV test will have blood drawn     for confirmation (Western Blot) and will be referred to an HIV clinic for follow-up and     treatment. Additionally, to assess acceptability of rapid testing in the ED, a brief     anonymous electronic survey will be conducted of health care providers in the ED prior to     starting this pilot program and following the program.      Data Analysis The yield of testing will be calculated as will the seroprevalence of those     tested. Among patients who decline HIV testing but agree to study participation (sign consent     form), the number refusing testing will be recorded and reasons for refusing will be     analyzed. The yield of testing will be compared in patients with to those without known HIV     risk factors.   "
239309|NCT00987207|"     Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a     cardioprotection during the valvular surgery.   "
239310|NCT00987220|"     It is hypothesized that the acetylcholinesterase inhibitor, donepezil, will increase acute     cerebrospinal fluid (CSF) actylcholine levels in healthy volunteers following a 5mg single     dose oral administration.   "
239311|NCT00987233|"     A randomized, double-blind, placebo-controlled parallel-group study, comparing the     bioequivalence of triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) to that of     Nasacort® AQ nasal spray (Sanofi-Aventis Pharmaceutical Products, Inc.) in the treatment of     seasonal allergic rhinitis.   "
239312|NCT00987246|"     The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo     and to LAS106521 in actinic keratosis (AK).   "
239313|NCT00987259|"     Despite recent improvements in treatment, myocardial infarction (heart attack) is still a     leading cause of illness and death in the UK. Following the acute event, it is difficult to     predict which patients are at risk of further problems, such as heart failure and is     therefore difficult to know which patients need more aggressive/intensive treatment and     monitoring.      There needs to be a test which is safe, reliable and reproducible that can be used shortly     after a heart attack to both predict future cardiac events and to allow the efficacy of new     treatments to be assessed.      Myocardial oedema (swelling of the heart muscle) has been demonstrated using Cardiac Magnetic     Resonance (CMR), to occur following a heart attack and has been suggested as a marker for     future cardiac events. The optimum time to perform this scan, the method of data analysis and     it's effectiveness as a predictor of future cardiac events has not been adequately assessed.      This trial will assess the amount and natural time-course of oedema in the first 10 days     following a heart attack. It will also correlate the amount of oedema with the size of scar     (damaged heart muscle) and left ventricular ejection fraction (heart function) at 3 months to     assess if it is a predictive marker.   "
239314|NCT00987272|"     The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared     to its vehicle in Japanese subjects in the treatment of acute allergen-mediated     conjunctivitis using the conjunctival allergen challenge (CAC) test.   "
239315|NCT00987285|"     This project is primarily a behavioral study. We employed a three-arm, patient-randomized     practical effectiveness trial to evaluate the impact of two different interactive, multimedia     self-management programs, relative to enhanced usual care. The two interventions will be     (a) the revised program from our present study, based on our social-ecological theory and the     5 As self-management model, plus enhanced support (ASM+ES) that includes practical, but     extensive, ongoing support and b) largely Automated Self-Management (ASM). These programs     will be compared to a realistic enhanced usual care (UC) condition that will provide health     risk appraisal feedback, control for computer interactions, and provide standardized advice     on behavior change, but not the hypothesized key intervention processes of goal-setting,     barriers identification, problem-solving, or social-environmental support. Patients will be     randomized to conditions within clinic and will participate for 1 year.      The proposed project will test the effectiveness of a practical, automated-based intervention     for primary care patients to facilitate dietary and physical activity practices, and     medication-taking. Analyses will focus on primary outcomes of (a) dietary, physical activity,     medication-taking outcomes, and (b) the UKPDS risk equation as well as secondary     quality-of-life, patient-activation, and patient care outcomes (Specific Aim #2). Using the     RE-AIM measures, we will analyze the reach, effectiveness, adoption, implementation, and     maintenance of the intervention programs (Specific Aim #3), and also factors related to     program implementation, linkage to primary care, and program success with emphasis on cost,     cost-effectiveness, and mediators and moderators of outcomes such as social-environment     support (Aim #4).      Primary hypotheses:        1. That the Automated Intervention received by Automated self-management (ASM) condition          and ASM plus enhanced support conditions (ASM+ES) will be superior to usual care on the          primary outcomes.        2. That the ASM+ES condition will be superior to the ASM alone condition on primary          outcomes at the 12-month follow-up.   "
239316|NCT00987298|"     The goal of this project is to compare visceral fat measurements derived from Lunar iDXA     total body scans and from Computed Tomography (CT) scans of the abdominal region.   "
239317|NCT00987311|"     The purpose of this study is to investigate whether two different fermented dairy drinks     consumed daily could have an effect on the intestinal immune response in healthy subjects.   "
239318|NCT00987324|"     The purpose of this randomized study is to determine which treatment option, either     paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most     effective in the treatment of restenosis after implantation of Limus-eluting stents, (LES).   "
240226|NCT00993512|"     This study is an open, non- randomized, phase I, dose-escalating study to evaluate the safety     and tolerance of Amphinex based PCI of bleomycin in patients with local recurrent or     advanced/metastatic, cutaneous or sub-cutaneous malignancies.   "
239322|NCT00987376|"     Prostate cancer imaging using traditional anatomic modalities including CT, MR, and     ultrasound is limited. Improvement in current imaging modalities or development of new ones     should be a priority in prostate cancer research. Optimal treatment varies considerably for     patients with different staging characterizations and new imaging methods that more     accurately stage patients could lead to more appropriate treatment. The objective of this     study is to obtain preliminary, comparative data on new, promising imaging methods for     prostate cancer. PET/CT imaging using 11C-choline,11C-acetate, and Y86 or     18F-Adenosylcobalamin and MRI spectroscopy (MRS) of prostate cancer will be compared. Direct     comparison of these imaging methods has never been done and Mayo Clinic and Johns Hopkins are     uniquely able to conduct such a trial as an inter-SPORE collaboration.   "
239323|NCT00987389|"     The purpose of this study is to determine whether plasma exchange as well as     immunosuppressive therapy are effective in reducing death and end-stage renal disease (ESRD).     The trial will also study whether a reduced cumulative dosing regimen of glucocorticoids is     as effective as a standard disease regimen.      The FDA-OOPD is one of the funding sources for this study.   "
239324|NCT00987402|"     Surgical site infections (SSI) constitute a significant health-economic and clinical     challenge. The investigators conducted a cluster-randomized, cross-over study to compare the     efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for     surgical hand preparation, to alcohol-based hand rub (ABHR), with SSI rates as the main     outcome measure.      A total of 3317 patients undergoing clean and clean-contaminated surgery were included in the     study and followed up for 30 days.   "
239325|NCT00987415|"     The purpose of this study is to determine whether allopurinol is effective in relieving     symptoms of patients with heart failure and high blood uric acid levels.   "
239326|NCT00987428|"     The primary purpose of this trial is to determine whether an early Early Endoscopic     Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile     duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis     (ABP).   "
239327|NCT00987441|"     Infant neurobehavior alteration is predictor of later intelligence development. Many factors     would influence or are associated with infant neurobehavior, of which exist or appear during     perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective     method in relieving labor pain. Although previous studies showed that opioid used in epidural     analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation     associated manner, whether epidural analgesia itself would produce unpredictable effect on     newborn neurobehavior is still unknown. Hereby the investigators designed this trial to     investigate the hypothesis that epidural analgesia for labor pain control itself would not     produce negative effect on infant neurobehavior.   "
239328|NCT00987454|"     This study seeks to determine if erythropoietin alpha (EPO) administered to adult critical     care patients with moderate or severe traumatic brain injury improves neurological function     assessed at six months after injury.   "
239329|NCT00987467|"     Atopic keratoconjunctivitis (AKC) is a rare type of ocular allergy that is often associated     with eczema. Over time, the complications from this disease process lead to loss of vision     due to continual scarring of the corneal surface. The pathophysiology of AKC has not been     fully elucidated, and the triggers are still unknown.      Corticosteroids are very effective in controlling the acute symptoms of AKC. However, two     thirds of patients managed with a combination of oral antihistamine, topical mast cell     stabilizer, and intermittent topical steroid regimen eventually developed significant     keratopathy and vision loss. Additionally, there are many side effects of corticosteroids,     including local immunosuppression, cataract formation, and increased risk of glaucoma.      Cyclosporin A is an immunomodulator that specifically inhibits T lymphocytes by blocking the     expression of the interleukin-2 receptor. It also blocks the release of inflammatory     mediators from mast cells and eosinophils. Cyclosporin has no known side effects except for     burning upon instillation, and safe to use over long-term . The investigators have     demonstrated that a 0.05% ophthalmic emulsion of cyclosporine has been shown to be effective     at improving the ocular signs and symptoms of AKC over short-term. However, the long-term     efficacy of cyclosporine A in slowing the natural history of AKC and possible steroid sparing     effects have not been assessed. The investigators hypothesize that cyclosporine A can be used     as a mainstay treatment of AKC to control signs and symptoms over a long period of time and     also prevent the progression of this disease.   "
239330|NCT00987480|"     This is a genetic disease (transmitted through the parents' genes) called Fanconi Anemia.     Because of that genetic disease, the bone marrow has changed and now has failed, or has given     rise to a preleukemia called myelodysplastic syndrome (MDS) or leukemia (acute myelogenous     leukemia or AML).      Without treatment these complications of Fanconia anemia (FA) are fatal. The only treatment     that can cure these complications is an allogeneic transplant of stem cells, meaning, giving     the patient bone marrow cells from a healthy donor that can produce normal blood cells that     will replace the bone marrow that is sick.      What has been given for the treatment of FA in the past is to use a combination of low doses     of radiation to the whole body (total body irradiation) and low doses of the chemotherapy     drugs (cyclophosphamide and fludarabine) before the transplant. However, the use of radiation     can, later on, increase the chances of getting a second cancer of the skin, head or the neck.     These chances of a second cancer are higher than normal in patients with FA.      The purpose of this study is to find out if the doctors can do the same thing with the same     chemotherapy drugs used in the past. However physicians will use another chemotherapy drug     called busulfan instead of the radiation. The goal of this study is to get rid of the short     term and long term risks of the radiation. The first new part of this treatment will be to     replace drugs for radiation with chemotherapy drugs.   "
239343|NCT00987649|"     The purpose of this study is to determine whether the Risk of Ovarian Cancer Algorithm (ROMA)     is effective in the determination of a woman's risk of cancer when she is scheduled to have     surgery to remove a pelvic mass.      After Informed Consent is obtained, an Initial Cancer Risk Assessment will be made. A blood     sample will be collected within 30 days of the surgical procedure. Results of the surgical     procedure will be collected and analyzed against the CA125 and HE4 results used in the     calculation of the ROMA.   "
240227|NCT00993525|"     To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal     injection of ranibizumab for the management of persistent new vessels associated with     diabetic retinopathy.   "
239331|NCT00987493|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in     different ways. Some block the ability of cancer cells to grow and spread. Others find cancer     cells and help kill them or carry cell-killing substances to them. Drugs used in     chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth     of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide     may stop the growth of cancer by blocking blood flow to the tumor. Giving rituximab together     with bendamustine hydrochloride and lenalidomide may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving rituximab     together with bendamustine hydrochloride and lenalidomide in treating patients with     aggressive B-cell lymphoma.   "
239332|NCT00987506|"     The objective of this study is to prepare elements of response to the Haute Autorité de Santé     (High Health Authority) of France, which is expecting data relating to the routine use of     XIENCE V® endoprothesis within the 5 years following its marketing.   "
239333|NCT00987519|"     With the use of molecular methods new viruses have been detected in respiratory and     gastrointestinal tracts of both patients and asymptomatic subjects in recent years. The     clinical importance of these viruses has not been adequately studied.      The aim of this study is to use molecular methods to detect viruses in upper respiratory     tract and gastrointestinal tract of children with acute bronchiolitis, acute gastroenteritis     and febrile convulsions and to try to correlate the severity of clinical picture with the     amount of viruses present in clinical samples. The investigators will also try to detect the     increase in specific antibodies in paired sera.   "
239334|NCT00987532|"     The aim of this study is to test whether a parent-focused participatory intervention in     addition to gym lessons can enhance preschoolers physical activity compared to gym lessons     alone.   "
239335|NCT00987545|"     This is a 2-part study. In the first part (Part I, 8 subjects), biopsies will be obtained     from the resection site after keloid shaving and two weeks following resection to assess and     select biomarkers to determine the biologic effects that occur in shaved keloids. No drug     will be administered.      In Part II (32 patients) will be randomized to receive QAX576 or placebo. An initial drug     infusion will be followed by shave removal of keloids 6 - 8 days later followed by two     additional drug infusions 4 weeks apart. Two weeks following resection, punch biopsies will     be performed to assess biomarker responses. Patients will be followed-up for 52 weeks after     first drug administration to assess keloid recurrence (clinically and by 3D imaging), and by     physician's and patient's cosmetic assessments, and safety.   "
239336|NCT00987558|"     The primary objective was to investigate whether multiple-dose administration of ESL 800 mg     once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.   "
239337|NCT00987571|"     Carpal tunnel syndrome is caused by compression of the median nerve at the wrist. The     hypothesis is that ultrasound imaging can be used to visualize nerve compression in carpal     tunnel patients during hand activity, and normal subjects will not demonstrate any nerve     compression.   "
239338|NCT00987584|"     This study is under Molecular and Cellular Characterization of Myelodysplastic Syndromes     (MDS) (eProtocol 15369). The purpose of this proposed study is to analyze existing samples     taken from participants participating in a clinical trial evaluating the efficacy and safety     of investigational agent ON 01910.Na (eProtocol 16214). This study will use existing blood     and marrow samples to determine the rate and duration of objective hematologic and marrow     responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.      This study will use existing blood and marrow samples to determine the rate and duration of     objective hematologic and marrow responses, and duration of progression-free survival in     ON01910.Na-treated MDS patients.   "
239339|NCT00987597|"     The aim of the present study is to assess if a personal care program of smokers hospitalised     for acute coronary syndrome can change the smoking habits as compared with similar patients     in conventional care program at 6 months. The program includes a cognitive-behavioural     approach associated with a nicotine replacement treatment presented as an obligatory non     optional treatment. Patients are men and women of less than 70 years old hospitalised for     acute coronary syndrome. Major exclusion criteria is the presence of another dependence. The     program includes a cognitive-behavioural approach based on the specific technique of     exposure and the prescription of nicotine patch considered as other usual cardiologic     treatments for at least 6 months. The end point is the smoking habits at 6 months classified     as: no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by     the patient but a CO level > 10 ppm). 72 patients in each group will be included in 2 majors     sites.   "
239340|NCT00987610|"     Under the circumstances that appropriate first-choice guidewires for percutaneous coronary     intervention (PCI) for chronic total occlusion (CTO) have yet to be established, the     objective of this study is to determine appropriate first-choice guidewires. G-FORCE study is     a prospective multicenter randomized study between normal (distal tip size 0.014 inch) and     slender (distal tip size 0.010 inch or less) guidewires. Primary end point is lesion     penetration rate of the first choice guidewire.   "
239341|NCT00987623|"     The purpose of this study is to evaluate the performance of two daily disposable contact     lenses in a population of neophytes (new wearers).   "
239342|NCT00987636|"     Ewing Sarcoma      Primary objectives:      Standard Risk R1: in a randomised trial, to examine whether add-on treatment with zoledronic     acid in addition to induction and maintenance chemotherapy improves event-free survival in     patients with localised Ewing sarcoma and good histological response or with initial tumour     volume <200 mL compared to no add-on treatment.      *High Risk R2: in a randomised trial, to examine whether high-dose chemotherapy using     busulfan-melphalan with autologous stem cell reinfusion, compared with standard chemotherapy,     improves event-free survival in patients with localised Ewing sarcoma and poor histological     response or tumour volume ≥200 mL (R2loc). In patients with pulmonary metastases high dose     busulfan-melphalan chemotherapy with autologous stem cell reinfusion is randomised versus     standard chemotherapy plus whole lung irradiation (R2pulm).      Very High Risk R3: in a randomised trial, to examine whether the addition of high dose     chemotherapy using treosulfan-melphalan followed by autologous stem cell reinfusion to eight     cycles of standard adjuvant chemotherapy, compared to eight cycles of standard adjuvant     chemotherapy alone, improves event-free survival in patients with primary disseminated     disease.      *R2 accrual discontinued on December 1st 2015.   "
239346|NCT00987688|"     Traumatic brain injury (TBI) is a leading cause of death and long term disability,     particularly in young adults. Studies from Australia have shown that approximately half of     those with severe traumatic brain injury will be severely disabled or dead 6 months post     injury. Given the young age of many patients with severe TBI and the long term prevalence of     major disability, the economic and more importantly the social cost to the community is very     high.      Pre-hospital and hospital management of patients with severe brain injury focuses on     prevention of additional injury due primarily to lack of oxygen and insufficient blood     pressure. This includes optimising sedation and ventilation, maintaining the fluid balance     and draining Cerebrospinal Fluid (CSF) and performing surgery where appropriate. In recent     years there has been a research focus on specific pharmacologic interventions, however, to     date, there has been no treatment that has been associated with improvement of neurological     outcomes.      One treatment that shows promise is the application of hypothermia (cooling). This treatment     is commonly used in Australia to decrease brain injury in patients with brain injury     following out-of-hospital cardiac arrest. Cooling is thought to protect the brain using a     number of mechanisms. There have been a number of animal studies that have looked at how     cooling is protective and also some clinical research that suggests some benefit. However at     the current time there is insufficient evidence to provide enough proof that cooling should     be used routinely for patients with brain injury and like all treatments there can be some     risks and side effects.      The POLAR trial has been developed to investigate whether early cooling of patients with     severe traumatic brain injury is associated with better outcomes. It is a randomised     controlled trial, which is a type of trial that provides the highest quality of evidence.      The null hypothesis is that there is no difference in the proportion of favourable     neurological outcomes six months after severe traumatic brain injury in patients treated with     early and sustained hypothermia, compared to standard normothermic management.   "
239347|NCT00987701|"     Early change in neurobehavior is strongly associated with the intelligence development of     children. Previous studies reported that cesarean section itself could influence the later     development of children. In addition, neuraxial anesthesia including epidural, spinal and     combined spinal epidural anesthesia (CSEA) are the major forms used during cesarean delivery,     and these anesthesia techniques will undoubtedly evoke hypotension and corresponding     hemodynamic alteration, of which would result in decreasing in umbilical placental     insufficiency and fetus hypoxia leading to early abnormality of neurobehaviors in infants.     Fluid management, such as crystalloid and colloid, is the common ones given before or / and     after neuraxial anesthesia to prevent or reverse hypotension. However, it is still unknown     whether the perineuraxial anesthesia fluid resuscitation could improve the neurobehavior     scorings, and could produce positive effect on later intelligence development. Herein the     investigators hypothesized that effective perineuraxial anesthesia fluid management during     cesarean section would prevent the occurrence of hypotension and improve infant's     neurobehavior scorings.   "
239348|NCT00987714|"     The objective of this study is to determine whether protocol guided resuscitation of brain     dead organ donors using Pulse Pressure Variation (PPV) will increase the number of organs     transplanted per donor.      Specifically the study aims to:        1. improve resuscitation of potential organ donors.        2. improve organ function in donors.        3. increase organ recovery per donor.      The investigators will randomize 960 subjects to either protocolized resuscitation (n=480)     using a consensus-based PPV-guided algorithm or usual care using a 1:1 randomization scheme.     The primary outcome is the mean number of organs transplanted per donor. Secondary outcomes     include 6mHFS (six-month hospital-free survival) in the recipients, and mean number of organs     procured per donor that are suitable for transplantation (intention to transplant). The study     is powered to detect a 0.5 organ increase for transplantation per donor.   "
239349|NCT00987727|"     This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity     in symptomatic dry eye condition in absence of obvious eye-lid inflammation.   "
239350|NCT00987740|"     The purpose of this study is to evaluate the safety and efficacy of the Hemolung Respiratory     Assist System in patients with hypercapnic respiratory failure associated with acute     exacerbation of chronic obstructive pulmonary disease (COPD) and a 50% likelihood of failure     of noninvasive positive pressure ventilation leading to intubation and mechanical     ventilation.   "
239351|NCT00987753|"     The primary purpose of this study is to (1) determine the maximally tolerated dose (MTD) of     L-377202 administered once every 3 weeks, (2) evaluate the safety and tolerability of     L-377202 including the dose-limiting adverse effects of treatment with L-377202, and (3)     assess the pharmacokinetics of various doses of L-377202 and the plasma profile of liberated     doxorubicin and leu-doxorubicin.   "
239352|NCT00987766|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and     oxaliplatin together with erlotinib hydrochloride may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib     hydrochloride when given together with gemcitabine hydrochloride and oxaliplatin in treating     patients with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary     cancer.   "
239353|NCT00987779|"     Primary objective for this study is to demonstrate bioequivalence between Japanese commercial     tablet and Japanese commercial image liquid formulation. Secondary objective for this study     is to estimate the food effect for Japanese commercial image liquid formulation.   "
239354|NCT00987792|"     The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP)     patients on the disease including disease severity, clinical signs and symptoms and measures     used for diagnosis in daily routine practice as well as data on Avelox® including information     on the use, effectiveness, treatment outcome, safety and tolerability.      As this is a non-interventional observational study, routine clinical practice is observed.     The application of medications follows the normal routines and is decided by the treating     physician under recognition of the package insert.   "
239355|NCT00987805|"     The purpose of this study is to assess efficacy based on Gastrointestinal Symptom score and     safety based on the rate of adverse event or laboratory findings of Banhasasim-tang     administrated three times a day orally on functional dyspepsia.   "
239356|NCT00987818|"     The adequacy of early empiric antimicrobial therapy is an important factor in determining the     outcome in patients with severe sepsis. The duration of adequate antibiotic therapy in these     patients however is less clear. Duration of antibiotic therapy in patients with sepsis in the     ICU based on inflammatory markers has not been extensively studied.      Procalcitonin (PCT) is an acute phase protein that has prognostic value in critically ill     patients and can be used to monitor disease activity in sepsis and systemic inflammation.     This study will examine the effect of PCT guided antibiotic therapy compared with     conventional antibiotic therapy on treatment duration in patients with sepsis admitted to the     ICU.   "
239357|NCT00987831|"     Hypothesis: A reason for repeated disappointing outcomes of clinical trials testing targeted     immune biologics for lupus may be the heterogeneity of the disease, exacerbated by the     variable effects on immune homeostasis of the background medications that must be continued,     in most study designs, in these flare-prone patients.      Purpose of Study: This study was designed to purposefully study a population equivalent to     the placebo group of typical trials in SLE. In Group A patients entered the trial in     mild-moderate flare, were treated with depomedrol, and any background immune suppressants     withdrawn. Biomarkers at entry on various medications can be compared to biomarkers after     steroid efficacy with background immune suppressants withdrawn. Depomedrol usually wears off     over one to three months. Patients were closely observed, with serial biomarkers drawn at     monthly intervals or immediately at the time of a new flare. Those patients developing new     flares donated blood samples, were immediately treated as deemed appropriate, exiting the     study. Group A was designed for up to 50 patients and recruited a total of 41. An additional     group of 62 SLE patients donated blood once without additional interventions in order to     increase the power of exploratory cross-sectional biomarker analysis on different immune     suppressants (Group B). A control population of matched, healthy individuals donated blood     twice for the same biomarker studies to validate these assays (Group C).   "
239358|NCT00987844|"     Objectives: To evaluate the clinical long-term safety and the tolerability, patient     satisfaction, pharmacokinetics and use of pattern of prucalopride given in doses up to 4 mg     per day to patients with chronic constipation (CC).   "
239359|NCT00987857|"     RATIONALE: Screening tests may help doctors find cancer cells early and plan better     treatment. It is not yet known whether endoscopy every 2 years is more effective than     endoscopy only as needed in finding esophageal cancer in patients with Barrett esophagus.      PURPOSE: This randomized phase III trial is studying endoscopy every 2 years to see how well     it works compared with endoscopy only as needed in monitoring patients with Barrett     esophagus.   "
239360|NCT00987870|"     This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety     after multiple dosing.   "
239361|NCT00987883|"     Undernutrition is a state marked by energy and/or protein intake deficiency or     mal-absorption, and is often described as protein energy malnutrition (PEM). Malnutrition is     common in hospitalized patients worldwide. The prevalence of malnutrition in hospitalized     patients range from 20% - 50%, depends on the varieties of diseases, health system,     population and assessment tools. It is well documented in Western countries that malnutrition     affects clinical outcomes negatively. Compared with well-nourished patients, patients with     malnutrition stay longer in hospitals and related cost is significantly higher.      There is increasing evidence which indicates that appropriate nutrition support (e.g.,     standardized nutrition screening procedures, delivering nutrients with appropriate path, etc)     may improve clinical outcome on malnutrition, along with cost saving.      To date, there is no study to document specifically the impact of malnutrition and related     nutrition support on the health economics in China. Considering China now is on its way to     establish public health security system and a diagnosis-related grouping system, the     understanding of the cost effectiveness of nutrition support under the current clinical     conditions is crucial.      This study aims to investigate the prevalence of perioperational malnutrition in     gastroenterological cancer patient, the nutrition support status and related health economic     effects.   "
239362|NCT00987896|"     Megachannel is a newly developed colonic access system allowing rapid and multiple passes of     the colonoscope to the right colon.      The investigators want to conduct a multinational study to evaluate the safety and clinical     feasibility of placing a 100 cm Megachannel prototype in the right colon.   "
239363|NCT00987909|"     The main purpose of this trial is to investigate if any of three different doses of cat hair     immunotherapy is safe for treatment of cat allergic patients.   "
239364|NCT00987922|"     Hypothesis: Mild hypothermia using non-invasive temperature management system in a stroke     unit is safe and feasible in spontaneously breathing, alteplase-thrombolyzed patients with     acute ischemic stroke.   "
239365|NCT00987935|"     This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver     cancer patients   "
239366|NCT00987948|"     High levels of HIV infection within blood monocyte/macrophages (a type of white cells in the     bloodstream) increases risk of dementia in HIV-infected individuals. Maraviroc (Selzentry) is     a HIV medication that works by blocking the entry of HIV in cells including     monocytes/macrophages that use a receptor called CCR5. The study hypothesis is that the     addition of Maraviroc to a HIV antiretroviral regimen in HIV-infected individuals with high     levels of HIV-infected monocyte/macrophages will lead to a decrease in the levels of infected     monocyte/macrophages and to decrease in brain inflammation as studied by magnetic resonance     spectroscopy (MRS, a form of MRI study).   "
239367|NCT00987961|"     This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization,     and then providing an appointment (a link) for after discharge to maintenance buprenorphine     in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids.   "
239368|NCT00987974|"     Rationale:      Apart from their cholesterol lowering effects, statins have cholesterol‐independent     pleiotropic actions, such as upregulation of 5'‐ectonucleotidase and up‐regulation of     NO‐synthase that may increase tolerance against ischemia‐reperfusion injury (IR‐injury).     Several animal studies have shown reduction of IR‐injury as a result of statin treatment in     both the heart and the kidney. Recently the investigators have shown, using Annexin A5     targeting after voluntary ischemic exercise to assess IR‐injury, a protective effect of a 7     day oral rosuvastatin treatment. A three day treatment with atorvastatin however failed to     reduce annexin targeting.      Assessment of the flow mediated dilation of the brachial artery as measure of endothelial     (dys)function, is a validated model to research effects of possible protective strategies and     perform mechanistic experiments on IR‐injury in humans in vivo.      The investigators hypothesize that pretreatment with statins can increase endothelial     tolerance against ischemia and reperfusion injury.      Objective:      To study the protective effect of pretreatment (both 3 day and 7 day) with rosuvastatin and     atorvastatin on flow mediated dilation after 15 minutes ischemia and 15 minutes reperfusion.      Study design: placebo‐controlled randomised double‐blind trial      Study population: Healthy volunteers, age 18‐50      Intervention: Treatment with either rosuvastatin 20 mg, atorvastatin 80mg or placebo during     either 3 or 7 days      Main study parameters: Difference in flow mediated dilation before and after 15 minutes     ischemia.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Treatment with rosuvastatin or atorvastatin is not expected to harm the     volunteers. Most reported side effects of rosuvastatin and atorvastatin are gastro‐intestinal     complains and myalgia. The volunteers will not benefit directly from participating in this     study.   "
240377|NCT01002898|"     To assess 48-week treatment responses, tolerability, and steady-state minimum plasma     concentrations of ritonavir-boosted lopinavir monotherapy for salvage therapy in HIV-1     infected patients who failed antiretroviral regimens containing NRTI and NNRTI.   "
239369|NCT00987987|"     The investigators have previously shown that depletion of CD4+CD25+FoxP3+ regulatory T cells     (Treg) enhances the alloreactivity of T lymphocytes, as attested by an accelerated GVHD after     allogeneic hematopoietic stem cell transplantation (HSCT) in mice. The investigators thus     propose a clinical trial to test whether Treg-depleted donor lymphocytes infusion (dDLI)     could induce an improved graft-versus-tumor (GVT) effect in patients refractory to standard     DLI (stdDLI) for treatment of relapse after HSCT.   "
239370|NCT00988000|"     Consultations with patients by hospital consultants are organised today in a manner which is     barely dissimilar from that offered 30 or 40 years ago. Whilst some attempts to improve this     process, such as Choose and Book, shorter waiting times and patients' receiving a copy of the     correspondence sent to their general practitioner (GP) have improved the situation, there has     been little radical change and little thought given to the patient experience.      The investigators wish to investigate whether patients' experience of attending respiratory     outpatient clinics can be improved by a pre-clinic telephone call with a specialist thereby     reducing the number of attendances at the hospital for appointments and investigations and     improving overall patient satisfaction.   "
239371|NCT00988013|"     This is a phase I study using Intensity Modulated Total Marrow Irradiation (IM-TMI) in     addition to a chemotherapy regimen in preparation for an allogeneic stem cell transplant for     advanced hematologic malignancies such as acute myeloid or lymphoblastic leukemia, high grade     non Hodgkin's or Hodgkin's lymphoma, chronic myelogenous leukemia, and plasma cell leukemia.     Because the subjects participating in this study have a disease that is severe and has a high     risk of relapse even after transplant, the investigators propose to use a chemotherapy     regimen (fludarabine/busulfan), the name for the combination of chemotherapy drugs that is     given to patients prior to transplantation of the donor stem cells, along with intensity     modulated radiation (IM-TMI) to the bone marrow. Total body irradiation (TBI) in conjunction     with chemotherapy is a standard of care as a pre-conditioning regimen prior to bone marrow     transplant (BMT) in patients with hematologic malignancies. However, TBI can cause severe     side effects due to irradiation of organs such as the lenses of the eye, whole brain, lungs,     liver, kidneys, heart, small bowel and oral cavity. IM-TMI allows for the delivery of     adequate doses of radiation to the bone marrow while sparing other organs and therefore     limiting radiation side effects. The irradiation, along with receiving the chemotherapy drugs     will suppress the subject's immune system and kill off tumor cells, but will also intensify     the effect of the conditioning regimen thus allowing the bone marrow transplantation to have     a greater chance of being successful.      No investigational drugs are used in this study. The investigational part of this study is     the use of intensity modulated total marrow irradiation instead of conventional radiation.     IMTMI can deliver 99% of the prescribed treatment to the targeted bones and reduce the doses     of radiation to surrounding organs, as received in conventional TBI, by 29% to 65%.   "
239372|NCT00988026|"     This is a clinical trial to compare the benefits and possible adverse events of two     antibiotic treatments for mild to moderate acne. It is expected that minocycline     microgranules will be more effective than lymecycline with a better adverse events profile.   "
239373|NCT00988039|"     The trial aim is to ascertain what, if anything, needs to be combined with a boosted protease     inhibitor (bPI) backbone in second-line therapy in order to maximize the chance of a good     clinical outcome following WHO-defined failure on a first-line nucleoside reverse     transcriptase inhibitor (NRTI) and NNRTI-containing regimen with probable extensive NRTI and     NNRTI resistance mutations.   "
239374|NCT00988052|"     The purpose of this study is to make laquinimod 0.6 mg available for all subjects who     completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate     the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6     mg in subjects with relapsing multiple sclerosis.   "
239375|NCT00988065|"     This trial was conducted to study the potential for hypersensitivity symptoms at the time of     initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the     frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a     prolonged period.      In total 450 participants (all healthy subjects) were to be randomized to receive one of     three study treatments: three repeated doses of either sugammadex 4 mg/kg, sugammadex 16     mg/kg, or placebo. Participants were to receive one dose of study treatment on Day 8, Day 36,     and Day 78 of the study in order to determine the safety of each treatment dose.   "
239376|NCT00988078|"     The polycystic ovary syndrome is the most common endocrinopathy in reproductive age women.     The pathophysiology of this syndrome remains unclear, but there are evidences that a     decreased in insulin sensitivity may be related in this syndrome. There are studies that     showed the action of factors on the sensitivity of the insulin receptor, such as melatonin.     It is a hormone produced by the pineal gland, whose role is still uncertain in human     reproduction, although many studies have found that it may relate sex hormone effect. Many     patients with polycystic ovary syndrome (PCOS) may have hyperinsulinemia, and that     pinealectomized rats determined hypoglycemia and hyperinsulinemia, with reduced release of     insulin in response to glucose. Therefore, it is supposed that blood levels of melatonin     might correlate with the blood insulin concentration in patients with the syndrome. Moreover,     the insulin sensitizing agents have been used in the treatment of patients with insulin     resistance and PCOS, based on its main pathophysiological substrate which is the     hyperinsulinemia. In fact, the metformin is the most used in the literature. However, there     are few studies on the use of metformin in adolescents. The evidences of this drugs in this     group of patients have showed good therapeutic response with few side effects. The objective     of the study is to evaluate the effects of metformin on insulin resistance and levels of     melatonin in adolescents with PCOS. It will be performed a prospective, randomized,     double-blind and placebo-controlled study with 90 adolescents with PCOS. It will be evaluated     clinical and laboratory parameters (TSH, free T4, prolactin, FSH, LH, estradiol, total     testosterone, androstenedione, DHEA-s, 17-OH progesterone, SHBG, free androgen index, index     of HOMA-IR and QUICKI from fasting glucose and insulin, total cholesterol and fractions,     triglycerides, creatinine, AST and ALT and creatinkinase, fibrinogen and PAI-1, and melatonin     for 6 months of treatment.   "
239377|NCT00988091|"     Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of     either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety     for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of 1.2% sodium     hyaluronate and be followed for another 26 weeks.   "
239378|NCT00988104|"     The purpose of this study is to determine whether a newly developed, brief cognitive     behavioral intervention, relative to supportive counseling, is effective in reducing acute     stress disorder (ASD) and preventing post traumatic stress disorder (PTSD) and depression.   "
239379|NCT00988117|"     This is an open-label study to investigate the effects of the rivastigmine patch on attention     and behavior in Parkinson's disease when associated with memory and/or thinking problems.     Rivastigmine (also sold under the name Exelon) is an FDA approved medication used for the     treatment of mild to moderate Alzheimer's Disease (AD) and memory or thinking problems due to     Parkinson's disease. Recently a rivastigmine patch was developed, which has shown similar     effectiveness with fewer side effects and increased caregiver preference when compared to     capsules. This is an open-label 12 week study where 15 subjects diagnosed with Parkinson's     Disease who have mild to moderate memory and/or thinking complaints will be treated with the     rivastigmine patch at UCSF. This study also analyzes the mechanism by which the rivastigmine     patch works in people with Parkinson's disease and memory and/or thinking problems.   "
239381|NCT00988143|"     The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent     Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the     2008-2009 TIV among children and adults.      Primary Objective:      To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared     with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults.      Observational Objectives:        -  To describe the safety of the 2009-2010 TIV among subjects ≥6 months to <5 years, 18-60          years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype          QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age.        -  To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to          <5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of          2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of          age.   "
239382|NCT00988156|"     The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate     (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial     seizures whose condition has not been controlled by other drug treatments.   "
239383|NCT00988169|"     Advanced stage lung cancer is generally treated with anti-cancer medication called     chemotherapy. Most lung cancer is caused by cigarette smoking. However, some lung cancers     develop in people who never smoked or who only smoked for a short period of time. This type     of lung cancer may respond to a medication called erlotinib (Tarceva). Erlotinib is an     anticancer pill that is approved by the Food and Drug Administration (FDA) for use in     patients with advanced lung cancer. Unfortunately, erlotinib does not work for all patients     or only works for a period of time. The doctors are trying to find ways to improve the effect     of erlotinib by combining it with another anti-cancer medication.      Ascenta Therapeutics, Inc. has developed a drug called AT-101 as a potential treatment for     cancer. AT-101 is an investigational drug. That means that AT-101 is not approved by the     United States Food and Drug Administration (FDA) for general use. The FDA does permit its use     in studies like this one to determine whether it is safe and effective.      This is the first study to examine the effects of AT-101 and erlotinib. It is hoped that by     combining AT-101 with erlotinib, AT-101 may help erlotinib work better to shrink lung cancer.     Studies that have been performed in the laboratory suggest that AT-101 in combination with     erlotinib may be more effective at shrinking tumors than erlotinib alone.   "
239384|NCT00988182|"     The purpose of this study is to describe relationships among whey protein and its hydrolysate     when consumed before a meal on pre- and post-fixed meal satiety, blood glucose and insulin in     healthy young adults.   "
239385|NCT00988195|"     The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is     safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).   "
239386|NCT00988208|"     The purpose of the study is to determine whether lenalidomide is safe and effective for use     in combination with docetaxel and prednisone for the treatment of subjects with metastatic     Castrate-Resistant Prostate Cancer.      The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life     expectancy of these subjects.   "
239387|NCT00988221|"     This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active     polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or     were intolerant of methotrexate. In Part I of the study, all patients received intravenous     (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients     < 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate     response in Part I were randomized to receive either tocilizumab at the same dose as in Part     I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received     tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard     of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID),     corticosteroids, or methotrexate was continued throughout the study.   "
239388|NCT00988234|"     In the present study, the investigators will test the effect of two position on posterior     lumbar plexus and subgluteal or sub-greater trochanter sciatic nerve block.   "
239389|NCT00988247|"     Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone     dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol.     The subjects will be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA     is a steroid which is currently FDA approved for the treatment of asthma. BDP-HFA should be     safe and effective as a dry nasal aerosol which may be preferred by some patients.   "
239390|NCT00988260|"     The purpose of this study is to find the optimal dose of Org 37462 for Japanese females     undergoing controlled ovarian stimulation for in vitro fertilization intracytoplasmic sperm     injection (IVF-ICSI).   "
239391|NCT00988273|"     The main objective of this study is to determine the role of epithelial cell homeostasis in     the pathogenesis of intestinal diseases.      Background: Alterations in intestinal barrier function may play a significant role in the     pathogenesis of chronic intestinal diseases such as inflammatory bowel disease (IBD). The     intestinal epithelium functions as a barrier to the luminal contents, thereby preventing     undesirable solutes, micro-organisms and other luminal antigens from entering the body.     Confocal endomicroscopy has recently been shown that increased epithelial cell shedding may     contribute to increased intestinal permeability, at least locally. In our study, we want to     determine the contribution of epithelial cell shedding to intestinal permeability in vivo in     patients with inflammatory bowel disease compared to controls.      Scope:      In inflammatory bowel disease patients and controls (patients undergoing endoscopy for other     indications).      Methods:      We will perform confocal endoscopy during the patient's endoscopic procedure.      Procedure:      The patient will receive intravenous fluorescein, followed by confocal imaging of the     gastrointestinal tissue. The images are captured on the computer. The proposed study will     provide important insights into epithelial cell shedding as a contributor to altered     intestinal permeability.   "
239431|NCT00982423|"     The investigators' objective is to define the effects of decreasing the furosemide dose on     heart, kidney and humoral function in people with compensated heart failure and kidney     dysfunction and also in people with compensated heart failure without kidney dysfunction.     Secondly, to define the humoral activation in both groups.   "
239392|NCT00988286|"     Biofeedback therapy improves bowel symptoms and anorectal function in patients with     dyssynergic defecation, however its mechanism of action is not known. The investigators     hypothesize that biofeedback therapy enhances gut-brain-gut communication by altering     cortical processing of information and improving cortically mediated neuromuscular function     of the gut. The investigators' specific aims are; (1) To evaluate the afferent cortical     evoked potentials in response to the electrical stimulation of the anorectum (i) before and     after biofeedback therapy and (ii) compare responders with nonresponders. (2) To evaluate the     corticofugal tracts (efferent) by recording the anal and rectal electromyographic responses     following noninvasive lumbosacral and transcranial magnetic stimulation (i) before and after     biofeedback therapy and (ii) compare responders with nonresponders.      The investigators hypothesize that biofeedback therapy enhances gut-brain-gut communication     and alters cortical and neuromuscular function. The investigators' specific aims are to     evaluate 60 patients with dyssynergia (i) before and after biofeedback therapy and (ii)     compare responders with nonresponders by examining:      (A) The afferent cortical evoked potentials using electrical stimulation of the anus and     rectum.      (B) The efferent cortical evoked potentials by lumbosacral and transcranial magnetic     stimulation and recording the anal and rectal electromyographic responses.   "
239393|NCT00988299|"     In older, normal-weight women (60-75 yrs, BMI=18-28 kg/m2), an acute bout of higher-intensity     (60% of maximum effort) aerobic exercise, in comparison to an isocaloric bout of     lower-intensity (45% of maximum effort) exercise (caloric expenditure of 3.5 kcal/kg body     weight for both), will result in differential:        1. decline in non-exercise activity calorie expenditure in the subsequent 48 hours after          exercise;        2. increase in resting metabolic rate 48 hours after exercise;        3. increase in serum free triiodo-L-thyronine (free T3) concentrations immediately          following exercise;        4. decline from pre-exercise in plasma leptin and serum free T3 concentrations 48 hours          after exercise.   "
239394|NCT00988312|"     Patients with stage-I multiple myeloma are treated with a vaccine made from their own immune     cells (dendritic cells) and their own myeloma protein. Vaccinations are given on 5 occasions     every 4 weeks. The aim is to induce an immune reaction against the malignant myeloma cells in     order to slow down or cure the disease.   "
239395|NCT00988325|"     This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir     [Tamiflu] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours     prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will     receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10     doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued     study treatment for an additional 10 doses (5 days). The anticipated time on study treatment     is 4 weeks, and the target sample size is 65-85 male and female infants.   "
239396|NCT00988338|"     The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle     fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The     hypothesis of the study is that Trinity Evolution will result in fusion rates and clinical     outcomes similar to those obtained from autograft and other routinely used allograft     materials; these include: fusion, improvement in pain, improvement in function, and absence     of adverse events related to the use of the graft source.   "
239397|NCT00988351|"     The purpose of this randomized prospective study is to compare the efficacy of two approaches     to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having     obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway     involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended     sleep study) followed by CPAP treatment. The other pathway involves treatment with     auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP     adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time     (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep     Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two     study arms.   "
239398|NCT00988364|"     The purpose of this study is:        -  To identify the common factor for L5 prevalence in patients with Metabolic Syndrome.        -  To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting          factor and reduce L5 in Metabolic Syndrome patients.   "
239399|NCT00988377|"     The objective of this study was to describe relationships among whey protein when consumed     before a meal on food intake and pre- and post-meal satiety, blood glucose in healthy young     adults.   "
239400|NCT00988390|"     -  Context: Mothers living with HIV (MLH) and their children face predictable challenges:          maintaining physical and mental health, parenting while ill, and addressing HIV-related          stressors.        -  Objective: To evaluate the efficacy of a family-based intervention over time; to          contrast the life adjustments of HIV-affected families and their non-HIV-affected          neighbors in the current treatment era.        -  Design: Randomized controlled trial of MLH and a longitudinal comparison of MLH to a          neighborhood cohort using random effect regression.        -  Participants and Intervention: MLH (n = 339) and their school-age children (n = 259)          were randomly assigned to receive 1) an intervention of 16 sessions in a          cognitive-behavioral, small-group format; or 2) control. MLH and their children were          compared to non-HIV-affected families recruited at shopping markets. Participant          retention was high: 84% at 6 months, 83% at 12 months, and 78% at 18 months.        -  Main Outcome Measures: Family functioning and conflict, mental and physical health,          sexual behavior, and substance use.   "
239429|NCT00982397|"     The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system     performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate     at one year of subjects implanted with a Medtronic Protecta implantable cardioverter     defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be     evaluated. Phase II of the study will begin when the Medtronic Protecta devices are market     released in each participating geography. Subjects enrolled into Phase I of the study will     continue follow up in Phase II.   "
239430|NCT00982410|"     The proposed project will provide crucial data on the effectiveness of a pain management     intervention designed for veterans with co-occurring pain and substance use disorders. The     development of an empirically validated psychosocial intervention for managing pain and     substance misuse could greatly enhance the current set of options for treating this large and     understudied group of veterans.   "
239401|NCT00988403|"     Fructan is a carbohydrate polymer that is composed of fructose and a terminal glucose moiety     . Fructans are naturally found in artichokes (6.1 grams/serving), leeks (5.9 grams/serving),     onion bulbs (1.01 grams/serving), flour (4.0 grams/serving), garlic (.52 grams/serving),     watermelon (.92 grams/serving), nectarines (.27 grams/serving) and white peaches (.50     grams/serving). Because fructans are present in many common foods, people typically ingest     high levels of fructan. The most common structural forms of fructan are inulin, levanare and     geraminan . The human body absorbs only 5% of fructan, however it is estimated that the daily     intake in the USA may vary between 1-20 grams, and possibly higher due to the recently     discovered benefits of inulins . Dietary trends indicate that high levels of fructans are     common in the European and American diet, as more wheat based products such as breakfast     cereal, pasta, and bread are consumed.      Fructans may not be well tolerated by some subjects and its malabsorption may result in     gastrointestinal (GI) symptoms such as heartburn, belching, abdominal pain, diarrhea, gas,     and bloating; and this is especially true when higher doses are ingested. Unlike glucose,     fructans are not efficiently digested or absorbed by the small intestine. The mechanism for     malabsorption is related to the inability to hydrolyze glycosidic linkages in the complex     polysaccharide, resulting in the delivery of malabsorbed fructans to the large bowel1. In the     colon, the malabsorbed fructans are rapidly fermented, and byproducts of this fermentation     include H2, CH4, and other gases that may contribute to bowel symptoms. Furthermore, the     small molecular nature of fructans results in an osmotic effect which draws more water into     the small intestine and causes bloating and diarrhea.      Ingestion of high doses of fructans can cause symptoms in healthy adults, but may cause more     bothersome symptoms in subjects with Irritable Bowel Syndrome (IBS). Earlier studies have     identified that IBS affects between 10 and 15% of the population in the United States.     Ingestion of 10-20 grams of fructan daily may cause symptoms of IBS, and restricting fructan     intake in a diet may reduce symptoms in a variety of gastrointestinal disorders. One study     recently published found that dietary restriction of fructan and fructose was responsible for     symptomatic improvement in patients with IBS.      Hypothesis:      The investigators hypothesize that healthy individuals will absorb fructan 7.5 gram and 10     gram doses, and will experience malabsorption at the 12.5 gram fructan dose.   "
239402|NCT00988416|"     The purpose of the study is to prove the hypothesis that pancreas PET-CT can differentiate     duct involved IPMN with malignancy from duct involved non-malignant IPMN.   "
239403|NCT00988429|"     The purpose of this study is to determine whether Eslicarbazepine acetate (BIA 2-093) is an     effective adjunct therapy in the treatment of refractory partial seizures   "
239404|NCT00988442|"     This study tested a system of nursing telephone support to determine if it improves adherence     to antiretroviral therapy (ART) in at-risk, treatment-experienced people.   "
239405|NCT00988455|"     The purpose of this study is to evaluate the efficacy of photodynamic therapy (PDT)in     treatment of Basal cell carcinoma (BCC) and recurrence rate after 6 months.   "
239406|NCT00988468|"     Earlier research has shown that exercising while receiving manual therapy improves function     and reduces pain in people with knee osteoarthritis. However, very little is known about the     mechanisms by which manual therapy and exercise reduce pain and improve function. This study     will ask subjects with knee osteoarthritis to receive one of the following interventions: (1)     no treatment, (2) exercise only, or (3) manual therapy only. Measures will be taken of the     patient's knee range of motion, knee swelling and pain before and after receiving the     intervention. These measures will be analyzed to determine what effect exercise and manual     therapy applied to the knee have on improving knee range of motion and reducing knee pain and     swelling. Swelling will be measured using an ultrasound device which is used to take pictures     inside the knee. This type of ultrasound measurement is painless and harmless.   "
239407|NCT00988481|"     The goal of this study is to generate pilot data exploring the addition of an augmentation     (additional) medication to patients suffering from bulimia nervosa who have responded but not     had complete symptom resolution with a course of standard medication treatment.   "
239408|NCT00988494|"     Safety and efficacy of DE-105 ophthalmic solution in patients with persistent corneal     epithelial defect will be evaluated. Dose-dependent efficacy will be evaluated as well.   "
239409|NCT00988507|"     Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with     no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated     with artesunate - for a 3-day treatment.      Secondary objectives:        -  To assess the efficacy of ferroquine at one dose level alone for a 3-day treatment.        -  To assess the clinical safety of 4 treatment groups - 3 dose levels of ferroquine          associated with artesunate and one dose level of ferroquine alone.        -  To assess pharmacokinetics parameters of ferroquine and its metabolites along sparse          sampling schedules.   "
239410|NCT00988520|"     The purpose of this study is to compare the infusion rate of Org 9426 following intubating     dose of Org 9426 0.6 mg/kg or 0.9 mg/kg in adult surgical patients.   "
239411|NCT00988533|"     The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a     pediatric population aged 6 months to 3 years.   "
239412|NCT00988546|"     The purpose of this study is to compare C&P examination reports performed using a     Compensation and Pension Examination Program (CPEP) computerized, templated documentation     tool to a customary examination performed and then report dictated in quality, completeness,     timeliness and veteran satisfaction.   "
239413|NCT00988559|"     This study will test the efficacy and safety of different routes of administration of a DNA     vaccine in patients with HPV16+ CIN2/3. Subjects will be enrolled in one of six treatment     groups. Subjects enrolled in the first two groups will receive vaccination intradermally with     a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination     intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.   "
239414|NCT00988572|"     Dizziness has been identified as a risk factor for fall and vestibular asymmetry has been     found among patients with fall-related wrist fractures as well as among patients with     hip-fracture. Since wrist fracture is a risk factor for hip-fracture, much effort is focused     on preventing falls for risk-groups. Therefore, it would be interesting to find out if it is     possible to influence vestibular asymmetry with vestibular rehabilitation.      The aim of this study is therefore to find out if vestibular rehabilitation can have any     effect on vestibular function among patients with fall-related wrist fracture.   "
239415|NCT00988585|"     The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont     wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such     a dietary supplement on the market. The goal of this study is to test this oil at doses of     600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing     600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will     be randomized to one of four groups (30 in each group) and studied in both the fasting and     post-prandial state.   "
239416|NCT00988598|"     The purpose of the study is to evaluate the safety of PF-04447943 when given in combination     with donepezil in subjects who have Alzheimer's Disease. The study will also evaluate the     absorption and distribution of both PF-04447943 and donepezil.   "
239417|NCT00988611|"     The goals of this research proposal are to further our understanding of the reproductive     aging process in women and to improve our ability to clinically assess and model reproductive     aging. Reproductive aging is a continuous process that begins many years prior to menopause.     Women in their late 30s and early 40s usually maintain normal menstrual function and     ovulatory status, yet fertility in these women is considerably compromised compared to     younger women. The primary mechanism of reproductive aging is through the process of ovarian     primordial follicle (egg) depletion, a process that exhibits considerable variation between     women. As a result, the age at which an individual begins to experience infertility and     menstrual cycle changes secondary to follicle depletion also varies significantly and is     difficult to predict. The clinical assessment of the number of primordial follicles remaining     in the ovary has traditionally relied upon the measurement of ovarian or pituitary hormones     such as FSH, estradiol, and inhibin B. Unfortunately, these measures are all indirect and     poorly sensitive in the assessment of ovarian reserve. More recently, serum levels of     anti-Müllerian hormone (AMH) and the ovarian antral follicle count have been utilized as     clinical measures of ovarian reserve. Both have been correlated with chronological age and     have some predictive power in determining stimulation quantity (the number of oocytes     obtained at the time of egg-recovery) in in-vitro fertilization (IVF) treatment cycles.     Reproductive aging in women; however, is more than just the depletion of oocytes from a     woman's ovaries, but also involves a decline in oocyte quality. The predictive value of these     clinical markers of ovarian reserve with regards to oocyte quality is unknown. Additionally,     new tools developed to assess biological aging in other organ systems such as white blood     cell telomere length and the measurement of advanced glycation end products (AGEs) through     skin autofluorescence have not been evaluated with respect to the reproductive aging process.     This proposal seeks to develop better models of normal female reproductive aging by     identifying novel markers of ovarian reserve and determining their relationship with both     oocyte quantity and quality obtained during IVF treatment cycles.   "
239418|NCT00982254|"     This study compared the pharmacokinetic and pharmacodynamic properties of an oral insulin     formulation with that of a standard subcutaneous injection of regular human insulin.   "
239419|NCT00982267|"     The purpose of this study is to define the Maximum tolerated dose of SU14813 when     administered as single agent in patients with solid tumors.   "
239420|NCT00982280|"     The main objective of the study is to evaluate the effectiveness, tolerability, and safety of     tapentadol hydrochloride prolonged release (PR) in participants suffering from severe chronic     pain due to osteoarthritis of the knee who are taking WHO Step III analgesics and show lack     of tolerability. This is a clinical effectiveness trial designed to establish a link between     anticipated clinical outcomes and the clinical practice by means of selected measures of     clinical and subject-reported outcome. The trial will compare the effectiveness of previous     analgesic treatment (WHO Step III) with that of tapentadol hydrochloride PR treatment during     defined periods of evaluation.   "
239421|NCT00982293|"     The purpose of this study is to see if using a device called the Resonator, that puts out     very low level electromagnetic fields, effects blood glucose and A1c levels in people with     Type 2 Diabetes.   "
239422|NCT00982306|"     Alcohol abuse is a widespread concern internationally with a significant threat to world     health. Research suggests a relationship between heavy drinking and certain clinical     presentations such as injuries, physical and psychiatric illnesses and frequent sickness     absence from employment. This research aims to establish whether brief interventions     delivered to harmful and hazardous alcohol drinkers admitted to hospital impacts of their     alcohol consumption levels on discharge from hospital.   "
239423|NCT00982319|"     The purpose of this research is to examine the effect of a broccoli sprout preparation on     specific factors in breast tissue that are related to breast cancer risk and to assess     whether sulforaphane a key component of broccoli sprouts increases the levels of protective     enzymes in breast tissue. In addition, the investigators will also examine how acceptable the     broccoli sprouts preparation is to the study participants.   "
239424|NCT00982332|"     The study will examine the efficacy of a single intramuscular injection of betamethasone     dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml)     as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be     randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution)     immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy,     starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the     disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome     measures: the total cumulative dose of glucocorticosteroids and disease duration.   "
239425|NCT00982345|"     The purpose of this study is to find out what parts of the brain have increased or decreased     connectivity when people are depressed and how Seroquel extended release (XR) changes this     connectivity in depressed patients. The genetic samples collected are to look at variation in     a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin     in the brain.   "
239426|NCT00982358|"     This study is designed to support the use of valsartan in the diabetic population. Two     different groups will be studied, one with and one without coronary artery disease (CAD)     documented by angiography.      The study is intended to demonstrate that valsartan 320 mg has an anti-inflammatory     potential, reducing inflammatory serum markers as well as inflammatory gene expression, and     to show that valsartan is able to improve metabolic parameters in this patient population.     Furthermore, in the subgroup of patients with documented CAD this study wants to show that     valsartan improves coronary perfusion.      3 Objectives      Primary objectives:        1. To demonstrate the anti-inflammatory efficacy of valsartan 160/320 mg by testing the          hypothesis of superiority compared to placebo in the reduction of the inflammatory          marker Tumor necrosis factor alpha (TNFα) in plasma after 16 weeks of treatment in          hypertensive patients with type 2 diabetes mellitus.        2. To demonstrate the anti-inflammatory efficacy of valsartan 160/320 mg by testing the          hypothesis of superiority compared to placebo in the reduction of the inflammatory          marker Interleukin 6 (IL-6) in plasma after 16 weeks of treatment in hypertensive          patients with type 2 diabetes mellitus.      Secondary objectives:        1. To explore the effect of 160/320 mg valsartan on parameters of insulin sensitivity.        2. To explore the effect of 160/320 mg valsartan on additional inflammatory markers in          plasma [e.g. C-Reactive protein (CRP), soluble intracellular adhesion molecule-1          (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), serum amyloid A (SAA),          soluble CD40 ligand (sCD40L), fibrinogen, Interleukin 1β (IL-1β), matrix          metalloproteases -2, -3 and -9 (MMP-2, -3, -9), and sE-selectin)].        3. To explore the effect of 160/320 mg valsartan on inflammatory gene expression from          monocytes and fat tissue.        4. To explore the effect of 160/320 mg valsartan on metabolic gene expression in fat          tissue.        5. To explore the effect of 160/320 mg valsartan on coronary perfusion, in the group of          patients with angiographically documented CAD.   "
239427|NCT00982371|"     The number of people with type 2 diabetes is growing. This puts a lot of pressure on the     health care systems. Type 2 diabetes is often associated with health problems, like poor     eyesight, muscle coordination, muscle strength, and blood flow. Poor bone health may also be     a concern for people with type 2 diabetes.      A large proportion of people with type 2 diabetes will break a bone in their lifetime. The     risk of this happening in older people with type 2 diabetes is greater than the risk in older     people without diabetes. Fracturing a bone can be very painful, and lead to serious     consequences, especially if the individual experiences a hip fracture. The elevated fracture     risk, seen in those with type 2 diabetes, is puzzling because people with type 2 diabetes     often appear to have normal, healthy bones compared to people of the same age without     diabetes.      Bone micro-structure, which is not assessed by traditional bone densitometry systems (ie:     DXA) contributes to overall bone strength.      The hypothesis of this study is that bone micro-structure is of poorer quality (reduced     trabecular thickness, increased trabecular spacing) in postmenopausal women with type 2     diabetes, compared to age-matched control participants.   "
239437|NCT00982501|"     The purpose of this study is to test:        1. Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9          kg/m²)        2. Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking          training in overweight subjects   "
239438|NCT00982514|"     The study will examine the prevalence of venous thromboembolism in children with acute     lymphoblastic leukaemia treated in accordance with NOPHO ALL-2008. The investigators will     prospectively study clinical symptomatic thromboses, asymptomatic central line-associated     thromboses, and infections.   "
239439|NCT00982527|"     The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary     bypass in young children with congenital heart disease is able to reduce indicators of acute     kidney injury (biomarkers reduction, diuresis increase) compared to a control group.   "
239440|NCT00982540|"     The main objective of this study is to test prospectively the performance of an algorithm     stratified by an index based on neutrophil counts in association with galactomannan assay and     image tests to start an antifungal early therapy (empirical/preemptive) in neutropenic     patients. Ths specific objectives are to determine the overall incidence of invasive fungal     infections, use of antifungal agents, duration of hospitalization and mortality in this     cohort, and to evaluate if this strategy is associated with a reduction in the expected use     of antifungal agents if a classical empiric antifungal strategy was used, without an increase     in the incidence of invasive fungal infections.      This is a prospective, non randomized, non comparative study. Patients aged ≥ 18 years are     eligible if they have acute leukemia, myelodysplasia or other baseline disease submitted to     chemotherapy or to allogeneic stem cell transplantation with an expected duration of     neutropenia (neutrophil count <500cells/mm³) of at least 10 days. Exclusion criteria are     patients with and a past history of or invasive mold infection and those who do not want to     participate. The study has no comparator arm. However, the investigators intend to determine     if the algorithm based on the D-index would result in a 50% reduction in the use of     antifungal agents, if all patients with persistent fever and neutropenia received empiric     antifungal therapy. Based on our database of ~2,000 episodes of febrile neutropenia, 36% of     patients had persistent fever between days 4 and 7 of antibiotics and would receive empiric     antifungal therapy. A total of 105 patients will be needed to demonstrate a 50% reduction in     antifungal use if the investigators compared this cohort with a matched control historical     cohort (alpha = 5%, beta = 20%).   "
239441|NCT00982553|"     The purpose of this study is to look at levels of both a new anti-HIV drug called raltegravir     and an existing anti-hepatitis C drug called ribavirin to see if they affect the blood levels     of each other when given separately and together. This is a phase I, open-label, prospective,     three phase, pharmacokinetic study.   "
239442|NCT00982566|"     This is a randomized, single dose, open-label, multicenter crossover study to determine the     oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263     formulation being administered in ongoing Phase 1/2a studies. Approximately 48 evaluable     subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors     will be enrolled in this study.   "
239443|NCT00982579|"     Objectives:      Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to     HIV-1/2-uninfected mothers.      Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV)     when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine     within the first 4 weeks of life.   "
239444|NCT00982592|"     This randomized phase II trial studies combination chemotherapy when given together with     vismodegib to see how well it works compared with combination chemotherapy without vismodegib     in treating patients with advanced stomach cancer or gastroesophageal junction cancer. Drugs     used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving more than one drug     (combination chemotherapy) may kill more tumor cells. Vismodegib may stop the growth of     stomach or gastroesophageal junction cancer by blocking the growth of new blood vessels     necessary for tumor growth. It is not yet known whether combination chemotherapy is more     effective when given with or without vismodegib in treating stomach cancer and     gastroesophageal junction cancer.   "
239445|NCT00982605|"     The purpose of this study is to perform molecular diagnostic in mediastinal lymph nodes of     non-small cell lung cancer patients sampled by endobronchial ultrasound guided finde needle     aspiration (EBUS-TBNA).   "
239446|NCT00982618|"     This is a blinded randomized controlled trial in patients undergoing laparoscopic colon     surgery. The aim of this study is to assess whether perioperative intravenous lidocaine has     an impact on the early post operative physical activity recovery of patients scheduled for     laparoscopic colon surgery.      Twenty patients will receive thoracic epidural analgesia, twenty patients will receive     intravenous lidocaine plus patient-controlled analgesia (PCA) and twenty patients will     receive only PCA.      Hypothesis: patients receiving perioperative intravenous lidocaine, post operative recovery     will be faster and decrease pain intensity, opioid consumption and side effects, length of     hospital stay; probably as a result of a significant opioid sparing and attenuated     inflammatory response.   "
239448|NCT00982644|"     This trial is conducted in Europe and the United States of America (USA). The aim of this     trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in     subjects with type 2 diabetes never treated with insulin followed by the extension trial     investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin     glargine in subjects with type 2 diabetes.      All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant     enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl     peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment     is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor     treatment is also discontinued). Subjects who consent to participate in the extension trial     will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to     which they were randomly allocated in the 52 week main trial.      The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension     period is registered as NN1250-3643.   "
239449|NCT00982657|"     The safety and tolerability of CVX-060 have been established in the first-in-human clinical     trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and pharmacokinetics     (PK) profiles of combining CVX-060 with sunitinib in patients with advanced solid tumors, and     to subsequently assess the treatment efficacy of the combination treatment, as well as that     of sunitinib alone in patients with advanced renal cell carcinoma (mRCC).   "
239450|NCT00982670|"     An increased prevalence of the metabolic syndrome has been found in patients with systemic     lupus erythematosus in recent years.   "
239451|NCT00982683|"     The potential influence of lunar phases on human life has been widely discussed by the lay     press. The purpose of this study was to evaluate a possible relation between the lunar cycle     and the hemorrhagic complication rate and surgical outcome.      PATIENTS AND METHODS:      The investigators tested this hypothesis by evaluating the complication rate for 18760     patients who underwent surgery from January 2001 to December 2008 (103 lunar phases) at the     National Institute for Cancer Research in Genoa.      The date of definitive surgery was allocated to the lunar phases.   "
239452|NCT00982696|"     This study will investigate the efficacy of opioid growth factor (OGF) on tumor size and     survival in patients with head and neck cancer who have failed standard therapy.   "
239453|NCT00982709|"     Aim:      To determine the Responsiveness of the iMOBILITY in response to intensive physical therapy     exercise programs. (Is it sensitive to change?) Although exercise is thought to be the most     effective intervention for balance and gait in PD (compared to dopaminergic medication or DBS     surgery), the best exercise program for mobility in PD is unknown. The iMOBILITY will be used     to quantify balance and gait performance before and after two PT-supervised, intensive,     exercise programs, expected to improve balance and gait. The first program is a published     Treadmill training program and the second is the investigators new Agility training program     with sensorimotor progressions, targeted at specific impairments that underlie the     abnormalities of balance and gait in PD (developed for the Kinetics Foundation). This pilot     clinical trial will randomize 40 PD subjects into the two exercise programs at OHSU in     preparation for a larger clinical trial to determine the most effective exercise for mobility     disability in PD. The effects of exercise will be compared with no treatment during a 5-week     delay prior to start of exercise.      This trial will also determine the relative responsiveness (compared to traditional clinical     scales) of the iMOBILITY for testing the hypothesis that intensive exercise can improve     mobility in PD. We will use existing instruments (Berg Balance Scale, BEST of dynamic     balance, UPDRS, PDQ-39, 5 times sit-to-stand time and the Functional Performance Battery) to     show there is a difference between the exercise groups. Superior responsiveness of the     iMOBILITY system will be determined by larger differences with exercise intervention with the     iMOBILITY system than with traditional clinical measures of mobility in PD.   "
239454|NCT00982722|"     A randomised double blind clinical trial, accepted by the Medical Products Agency and     registered in the European Clinical Trials Database. Aims to evaluate the prevalence of     vitamin D deficiency in a pHPT population in relation to gender and age, the correlation     between vitamin D status, pre- and postoperative parathyroid hormone level and bone density     and the correlation between vitamin D status, metabolic, cardiovascular risk factors and QoL     aspects before and after parathyroid adenomectomy.   "
239455|NCT00982735|"     The CONTROL study is an out patient based prospective observational cohort study. The main     aim of the study is to survey the safety and efficacy of Micardis 40 mg/day and 80 mg/day     under real life conditions in usual clinical practice in essential hypertensive patients in     the Kingdom of Saudi Arabia. The patients participating in the study will be surveyed for 24     weeks.   "
239456|NCT00982748|"     The purpose of this study is to determine the feasibility and efficacy of yoga breathing     techniques to manage fatigue and other cancer-related side effects, in cancer patients     undergoing chemotherapy.   "
239457|NCT00982761|"     The purpose of this study is to discover the health status of occupational drivers. The     health status includes data collection of body mass index, blood pressure, central obesity,     anxiety scale scores, smoking habit and related cessation therapy, etc.   "
239458|NCT00982774|"     A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety,     tolerability, and immunogenicity of three injections of 10 µg LEISH-F2 + 25 µg MPL-SE given     at 14-day intervals as an adjunct to standard chemotherapy with sodium stibogluconate (20     mg/kg/day for 40 days) in patients with PKDL.   "
239485|NCT00988871|"     Background: Central venous pressure (CVP) monitoring from the peripherally inserted central     venous catheter (PICC) has not often been used because of the higher inherent resistance of     the PICC due to its longer length and narrower lumen. The objective of this study was to     assess the reliability of the CVP measured from PICCs as a predictor of the CVP measured from     CICCs in the setting of rapidly fluctuating hemodynamic conditions during liver     transplantation.   "
239486|NCT00988884|"     This study will evaluate the tolerability and immunogenicity of administration of the first     dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one     month prior to administration of Menactra™ and Adacel™.   "
239487|NCT00988897|"     Primary Objective:        -  To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6)          will provide a clinical disease control rate (DCR) of at least 20% at the end of the          chemotherapy.      Secondary Objective:        -  To evaluate other measures of tumour's responses and safety.   "
239489|NCT00988923|"     The purpose of this study is to verify the short-term effects of hyperthermia (HT) in pain     relief and in functional impairment in patients affected by mild to moderate idiopathic     carpal tunnel syndrome.      A single blind randomized sham-controlled trial was performed. A 23 patients were affected by     idiopathic CTS, 11 of them were affected by bilateral CTS.      the intervention consists of Hyperthermia device treatment, treated for 20 minutes per     session, a total of 8 sessions. Primary outcome is pain (Visual analogic scale).   "
239509|NCT00994279|"     RATIONALE: Yoga and wellness classes may reduce fatigue and improve mood, sleep, and quality     of life in women receiving chemotherapy for breast cancer. It is not yet known whether yoga     is more effective than wellness education for women with breast cancer who are undergoing     chemotherapy.      PURPOSE: This randomized phase II trial is studying a community-based yoga class to see how     well it works compared with an educational wellness class for women with stage I, stage II,     or stage III breast cancer undergoing chemotherapy.   "
239459|NCT00982787|"     The purpose of the Phase II clinical trial will be to see if a botanical extract from the     plant Passiflora incarnata can improve seizure control and reduce anxiety in patients     diagnosed with partial epilepsy.      The investigators will randomize approximately 25 participants with partial epilepsy for this     placebo controlled, double blind, and crossover study. All patients will be scheduled for 10     clinic visits and four telephone visits during the 32-week period of the trial. After     enrollment into the study, all participants will begin a 9-week observation phase, which     serves as an individual baseline control. After 9 weeks participants will be randomized to     receive either study drug or placebo for an 11 week study period. After completion of the 11     week study period, patients will crossover to the other study drug/placebo arm for another 11     weeks. Epilepsy participants will continue taking their anti-epileptic medication as     currently prescribed. The investigators will find participants through the OHSU clinics, by     notifying local neurologists, anthroposophical and naturopathic practices, and by advertising     the study via the local chapter of the American Epilepsy Society.      Routine blood tests, physical examinations and tests to monitor heart, brain and muscle     activities will screen for any adverse effects. The primary outcome measure will be seizure     frequency through seizure diaries. Attention and performance tests, neurological and quality     of life questionnaires will be completed to assess the secondary outcome measures of anxiety,     cognitive function and quality of life.   "
239460|NCT00982800|"     The Acute Pain Service (APS) at Sunnybrook has been using Gabapentin 200 mg three times a day     (TID) resulting in anecdotal benefits in terms of analgesia and opioid sparing effects.     Higher doses of Gabapentin were associated with an increased incidence of sedation. The     purpose of the study is to investigate if Gabapentin 200 mg given three times a day for 72     hours (9doses) results in a reduction in the total amount of opioid required after radical     prostatectomy surgery as compared to placebo, and if analgesia is improved. This study will     also examine the possible anxiety sparing effects and any health related quality of life     (HRQL) changes, which may be a result of our perioperative use of gabapentin.   "
239461|NCT00982813|"     The aim of the study is to determine the influence of the periodontal diseases in patients     giving pre-term birth in the maternity hospital of Nantes. A French population is observed.     The clinical, bacteriological and microbiological aspects will confirmed a comparative study     which aim is dental prevention in the beginning of the pregnancy to avoid premature delivery.   "
239462|NCT00982826|"     To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation     administered as a single dose and then administered as multiple doses for 7 days. The effect     of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be     evaluated.   "
239463|NCT00982839|"     At least 60% of patients with constipation and dyssynergic defecation (anismus) and between     30-50% of patients with fecal incontinence exhibit impaired rectal sensation. The problem may     be improved by biofeedback therapy. Traditionally, biofeedback therapy was performed by using     a syringe-assisted technique. Although some respond to this method, many, particularly those     with severe rectal hyposensitivity have proved to be refractory. Also, repeated inflation and     deflation of a large volume of air, using a hand-held syringe is cumbersome and time     consuming. Recently, in pilot observations, the investigators have seen that a     barostat-assisted technique of biofeedback therapy was simpler and easier to perform and     could possibly be more effective. The investigators' aims are:        1. To perform a randomized controlled study that compares the syringe-assisted sensory          conditioning (biofeedback therapy) technique with the barostat assisted sensory          conditioning for improving the rectal sensation in patients with rectal hyposensitivity          and bowel dysfunction.        2. To investigate the impact of sensory conditioning on psychosocial issues and quality of          life.        3. To compare the cost-effectiveness of each therapeutic modality The specific hypotheses          that will be tested are;      When compared to those who receive syringe-assisted training, patients receiving barostat     training will demonstrate:        1. Lower sensory thresholds for rectal perception (first sensation, desire to defecate and          urgency)        2. Greater satisfaction with bowel function (VAS Score), stool frequency,consistency &          straining.        3. Better learning ability and greater ease of administering this training.   "
239464|NCT00982852|"     Patients enrolled will need treated with an IVUS- VH (intravascular ultrasound-derived     virtual histology) which is an arterial stent procedure, that involves threading a tiny wire     into the artery, followed by a balloon, a stent, or other device to treat a blocked artery,     and often (though not always), a special ultrasound catheter to take pictures of the inside     of the artery.      Participants in the study, will have an additional procedure performed: a tiny tube will be     advanced into the heart artery to collect a blood sample for research purposes, and a blood     sample will be collected from the femoral (thigh) artery through the tube that will be placed     there as a standard part of having this procedure.      The blood that is collected will be analyzed for markers of inflammation or irritation in the     blood (c-reactive protein, myeloperoxidase, Monocyte chemotactic protein-1), as well and a     gene called Matrix Metallopeptidase 3, which is believe to influence the progression of     plaque on the walls of arteries and the progression of coronary artery disease. .   "
239465|NCT00982865|"     This is a first in man trial with a primary objective being the determination of the Maximum     Tolerated dose (MTD) and the dose-limiting toxicity (DLT) in several regimens of MEK     inhibitor MSC1936369B administered orally once a day, in subjects with malignant solid tumors     to see how safe is treatment with MSC1936369B.   "
239466|NCT00988624|"     This study will evaluate four different modified release formulation to estimate the amount     of dimebon available to the body relative to the current dimebon formulation that is given     three times a day. The results of this study will help inform and guide further formulation     development efforts with the ultimate goal of reducing dose frequency to once-a-day or     twice-a-day.   "
239467|NCT00988637|"     This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate)     Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one     of two different regimens:        1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray          treatment twice daily on weekends (Sat - Sun) for 28 days        2. Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days   "
239468|NCT00988650|"     While there is now undisputable evidence relating elevated plasma low-density lipoprotein     (LDL) cholesterol levels to an increased risk of coronary heart disease (CHD), it is being     increasingly recognized that a significant proportion of CHD events occur in individuals     characterized by a cluster of additional metabolic and physiological perturbations now     defined as the metabolic syndrome. Epidemiological and clinical evidence have shown us that     nutritional factors, often in conjunction with obesity, play a pivotal role in the     pathophysiology of the metabolic syndrome. In that regard, accumulating evidence suggest that     a Mediterranean-style diet (MedDiet) may beneficially modify several components of the     metabolic syndrome including plasma triglycerides (TG) and high-density lipoprotein (HDL)     cholesterol levels, insulin resistance, waist circumference and markers of vascular     inflammation. However, the physiological mechanisms underlying the cardioprotective effects     of the MedDiet on features of the metabolic syndrome and the importance of body weight     reduction in maximizing these effects represent key issues that have yet to be investigated.      The general objective of the study is to investigate for the first time in a controlled     feeding study the mechanisms and factors underlying the impact of the MedDiet, with and     without weight loss on the dyslipidemic features of the metabolic syndrome.   "
239469|NCT00988663|"     The purpose of this study is to determine whether memantine will enhance the therapeutic of     effect on depression and prevent memory and other cognitive problems caused by ECT.   "
239470|NCT00988676|"     High quality bowel cleaning preparation was most important prerequisites of a accurate     colonoscopy, because even a small amount of residual fecal matter can obscure small polyps     and increase unnecessary procedure time. Until now, several studies evaluated the impact of     bowel preparation on the quality of colonoscopy using comparison of the polyp detection rate     in patients with adequate bowel preparation status to that in patients with inadequate bowel     preparation status during colonoscopy. However, there was no direct measurement the effect     bowel preparation status on the polyp missing rate, the quality of colonoscopy, using tandem     colonoscopic evaluation in prospective setting.   "
239471|NCT00988689|"     The investigators hypothesize that different types of starch vary in their effects on     appetite, blood sugar and food intake. In this study, subjects consumed five soups containing     50 g of whole grain, high amylose corn, regular corn or maltodextrin starches or no added     starch at one week intervals. The investigators measured food intake at 120 minutes, appetite     and blood sugar.   "
239472|NCT00988702|"     The present study aimed to utilize these well-known neuroelectrophysiological techniques to     investigate the relatively less studied Shaolin Dan Tian Breathing (DTB) technique.   "
239473|NCT00988715|"     This phase I trial studies pretargeted radioimmunotherapy and donor peripheral blood stem     cell transplant employing fludarabine phosphate and total-body irradiation (TBI) to treat     patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or     myelodysplastic syndrome. Giving chemotherapy drugs, such as fludarabine phosphate, and TBI     before a donor peripheral blood stem cell transplant helps stop the patient's immune system     from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies can be combined     with fludarabine phosphate and TBI to find cancer cells and kill them without harming normal     cells. Pretargeted radioimmunotherapy (PRIT) allows for further improved targeting of tumor     cells over standard directly labeled antibodies.   "
239474|NCT00988728|"     The purpose of this study is to assess whether SCH 900435 (Org 25935) 16 mg twice daily is     more effective than placebo in the treatment of patients with schizophrenia, using olanzapine     15 mg once daily as active control.   "
239475|NCT00988741|"     This is a global randomized, placebo-controlled, double-blinded Phase 2 study designed to     compare treatment of ARQ 197 versus placebo in patients with unresectable HCC who had     radiographic disease progression after systemic first line therapy or were unable to tolerate     the therapy.   "
239476|NCT00988754|"     The purpose of the study is to determine whether a school based health promotion program in     secondary schools is effective with respect to an increase of physical activity, physical     fitness and health.   "
239477|NCT00988767|"     The purpose of this study was to investigate whether HBV-DNA vaccination is safe and could     restore immune responses in patients with chronic hepatitis B non responder to available     therapies.   "
239478|NCT00988780|"     The purpose of this study is to determine if Maraviroc administration can decrease IRIS     incidence in HIV infected patients initiating ARV therapy.   "
239479|NCT00988793|"     The study will randomized patients to either open or laparoscopic pancreatic surgery. The     primary purpose of the study is to determine whether laparoscopic distal pancreatectomy is     associated with improved outcomes compared to open distal pancreatectomy.   "
239480|NCT00988806|"     The purpose of this study is to determine whether the treatment strategy of long-term     intermittent every 30 days, continuous intravenous infusion for 24 hours of Levosimendan,     associated to optimal contemporary treatment for advanced heart failure reduce the incidence     of admission for heart failure worsening at 12 months follow up, compared with the strategy     based solely in the optimal contemporary treatment for advanced heart failure.   "
239481|NCT00988819|"     The overall objective of this study is to investigate in depth the nature of metabolic     physiology, body composition and epigenetic differences of the different phenotypes of     overweight and obese individuals who are otherwise overtly healthy among the three major     ethnic groups in Singapore.   "
239482|NCT00988832|"     The aim of this study is to quantify how infliximab therapy is being used in the UK and the     consequent impact on health care resources, which will help to inform budget holders and     payers on the costs associated with the treatment of Crohn's Disease.   "
239483|NCT00988845|"     This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen     profile in women across a range of body mass index.   "
239484|NCT00988858|"     The primary purpose of this study is to evaluate the efficacy and safety of LY2603618 in     combination with pemetrexed and any side effects that might be associated with it along with     determining the effects of LY2603618 in combination with pemetrexed in participants with     advanced or metastatic Non-small Cell Lung Cancer (NSCLC).   "
239488|NCT00988910|"     The purpose of this study is to evaluate the symptoms and satisfaction for women taking     drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking     other kind of combined oral contraceptives.   "
239490|NCT00988936|"     A Pilot Phase II Study      The primary objective for this study is:        -  To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response          to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full          course of treatment is completed      The secondary objectives for this study are:        -  To continue safety evaluation by collection of safety data from all patients        -  To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and          conduct of future studies      Design: An open label, non-randomized, uncontrolled, single group assignment, pilot efficacy     study      Duration: Screening visit (3-4 hrs), pre-treatment imaging visit of [F-18]RGD-K5 PET/CT (~     3-4 hrs) and the standard [F-18]FDG PET/CT (~ 3-4 hrs) or diagnostic CT, followed by two     [F-18]RGD-K5 PET/CT scans, one after the second but before the third Avastin® treatment, and     one after the fourth but before the fifth Avastin® treatment, and a follow up standard     [F-18]FDG PET (~ 3-4 hrs) or diagnostic CT.      Procedures: Informed consent, collection of demographic information, medical history, blood     labs, physical examination, vital signs, ECGs, three sets of [F-18]RGD-K5 dosing and imaging     scans including pretreatment, early mid-treatment, and later mid-treatment, concomitant     medication collection, adverse event monitoring, and assessment of tumor response to     treatment      Patients: Approximately forty (40) patients with non-squamous non-small cell lung cancer,     metastatic breast cancer, metastatic colon or rectum cancer who will receive chemotherapy     plus Avastin®. This allows for approximately 30 evaluable patients to complete this study at     approximately four to eight sites internationally   "
239491|NCT00988949|"     This study will be a Proof of Mechanism (POM) study to establish evidence of central     pharmacodynamic activity for PF 04455242, and will be a parallel group, randomized, double     blind, sponsor open study conducted in healthy male subjects. Once subjects achieve steady     state of PF 04455242, they will undergo PF 00345768 (spiradoline) challenge. Data will be     analyzed to determine whether PF-04455242 blocks spiradoline induced prolactin release.   "
239492|NCT00994058|"     The objective is to test a novel paradigm for the inhibition of human preterm uterine     contractions.      The study hypothesis is that human preterm contractions can be safely inhibited with a weak     electrical current provided by an electrical inhibition/uterine pacemaker device.      Preterm birth is still a major problem. Current methods of preventing the uterine     contractions of preterm are limited and associated with many side-effects affecting both the     mother and baby. A reliable method of preventing preterm uterine contractions would be an     important discovery. Such a method could eventually lead to a long-term goal of decreasing     neonatal morbidity and mortality.   "
239493|NCT00994071|"     Background:      - An experimental drug called ABT-888 has been studied in combination with temozolomide (a     type of chemotherapy) in adults who have certain kinds of cancer. ABT-88 has been shown to     increase tumor sensitivity to temozolomide and improve treatment outcomes in people who have     cancer. More research is needed to determine if this combination of drugs will work well as     an effective treatment for children who have brain tumors. This will be the first time this     combination has been studied in pediatric patients.      Objectives:        -  To determine the maximum doses of ABT-888 and temozolomide when given in combination in          children with brain tumors.        -  To learn how children metabolize and clear ABT-888 from their bodies so that appropriate          doses of this medication can be recommended for future clinical trials of this drug.        -  To learn what side effects may occur when ABT-888 and temozolomide are given together.        -  To learn how certain tumors respond to this combination of drugs by studying the          characteristics of these tumors in a laboratory.      Eligibility:      - Individuals less than 21 years of age who have been diagnosed with a cancer of the nervous     system (including brain and brain stem tumors) that has not responded to standard therapy.      Design:        -  Before beginning the study, participants will have a full medical history and physical          examination, and may also be required to have scans of the brain and spine or provide          samples of cerebrospinal fluid.        -  Treatment will consist of up to 13 28-day cycles of therapy, for a total of 52 weeks (1          year). Participants will receive a dose of ABT-888 twice daily for 5 days, and will          receive a dose of temozolomide once daily for 5 days, every 28 days. The morning dose of          ABT-888 will be given 60-90 minutes before the dose of temozolomide.        -  Participants will have routine blood tests at least once a week throughout the treatment          cycles, and will have scans of the brain and spine performed as required by the          researchers.   "
239494|NCT00994084|"     The collaborative study is to determine the effectiveness of an after-school community-based     program to prevent obesity among minority children.   "
239495|NCT00994097|"     The main objective of this study is to demonstrate superiority in progression-free survival     (PFS) when NGR-hTNF is added to standard chemotherapy regimen (cisplatin/gemcitabine or     cisplatin/pemetrexed) in locally advanced (stage IIIb with supraclavicular lymph node     metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent     non-small cell lung cancer (NSCLC).   "
239496|NCT00994110|"     The purpose of this study is to help us learn more about how to lower the patient's risk of     the most common complications after their pancreas operation. After tumors are removed and     the remaining part of the pancreas is connected to the intestine or closed, a leakage of     pancreatic fluid may occur. This fluid may form an abscess (collection of pus) or fistula     that would need to be drained. A fistula is a persistent leakage of pancreatic fluid that     sometimes occurs after pancreatic surgery. Fistulas, leaks, and abscesses are complications     that are seen in roughly every 15-20 patients out of every 100 that have pancreas surgeries.     Complications like these extend the patient's stay in the hospital after surgery. These     complications may require the patient's doctor to perform additional tests or procedures to     treat them.      The physical and emotional burden these complications place upon patients, as well as the     financial cost to the health care system, can be great. The surgeons at Memorial     Sloan-Kettering Cancer Center are conducting a study to determine if a drug, SOM230, can help     reduce the rate of these complications. SOM230, also known as Pasireotide, is a drug that has     been observed to reduce the rate of similar complications in other studies.      The surgeon would like to compare the effects, good and/or bad, of SOM230 with placebo     (solution without medication) to see if SOM230 reduces the rate of fistulas, leaks and     abscesses.   "
239497|NCT00994123|"     A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung     cancer (NSCLC).   "
239507|NCT00994253|"     The purpose of this study is to assess the effect of Tekturna (aliskiren), in combination     with an ACE and calcium channel blocker in hypertensive patients diagnosed with Type II     diabetes.   "
239508|NCT00994266|"     The purpose of this study is to assess the efficacy of Diamel (dietary supplement)     administration in the treatment of patients with type 2 diabetes receiving insulin therapy.     The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.     The estimated number of patients to be recruited and randomized for the study is 116. Daily     insulin requirements, blood glucose (fasting and post-prandial) concentrations, glycosylated     hemoglobin (HbA1c), triglycerides and cholesterol will be assessed at the beginning and after     24 weeks of treatment.   "
239498|NCT00994136|"     Long-term central venous access devices are considered as safe for the administration of     medication as chemotherapy, but are also used for blood sampling. For years these catheters     have been locked with a heparin solution in order to avoid occlusion. However, no scientific     evidence supports heparin locking when the device is not in use. Advanced technology as     needleless caps and valved catheters and port reservoirs confirms this trend to use 'saline     only' for locking these devices. Therefore the investigators hypothesize is that there will     be no difference in proportion of occlusions and catheter related bacteremia in long-term     venous access devices locked with 'saline only' versus with heparin.   "
239499|NCT00994149|"     Diazoxide is an oral hyperglycemic medication. Diazoxide has been proven effective for     treating hypoglycemia in infants and children with some types of persistent hyperinsulinemic     hypoglycemia. The mechanism of action results in decreased insulin secretion. One of the     causes of hypoglycemia in infants of diabetic mothers occurs due to a transient     hyperinsulinemic state postnatally. The investigators have clinical experience and success     using diazoxide in their unit for patients with hypoglycemia not adequately managed with     intravenous (iv) dextrose and enteral supplementation. In this randomized controlled study     the investigators expect that by using diazoxide as the initial treatment for infants of     diabetic mothers with asymptomatic hypoglycemia (blood glucose of 2.5 to 2.0mmol/L), the     investigators will be able to decrease the number of infants requiring an intravenous by at     least thirty percent.   "
239500|NCT00994162|"     The aim of this evaluation is to assess the performance of the EZCare◊ product, in many     different clinical environments, in order to gain a greater insight into the effects of this     negative pressure wound therapy (NPWT) in a variety of wound types.   "
239501|NCT00994175|"     Background:      - Individuals who have severe asthma that is not easily controlled by current treatments are     in need of new treatments to prevent potentially life-threatening asthma attacks. Experiments     in mice have found that a medication called pioglitazone hydrochloride (Actos ), which is     used to treat patients with diabetes, may be effective for treating severe asthma.     Researchers are interested in determining whether Actos is effective in improving the quality     of life in subjects with severe asthma who continue to have symptoms despite maximum standard     medical therapy.      Objectives:      - To assess the effectiveness of pioglitazone hydrochloride as a treatment for patients with     severe asthma that is not controlled by standard treatments.      Eligibility:      - Individuals between 18 and 75 years of age who have been diagnosed with and treated for     severe asthma for at least 1 year.      Design:        -  Potential participants will have a screening visit to determine eligibility for the          study. The visit will involve breathing tests, chest x rays, heart and lung monitoring,          and blood tests.        -  Eligible participants will have a full medical history and will answer a series of          questionnaires about their quality of life with asthma.        -  Phase 1: Patients will record lung function and asthma symptoms morning and evening for          4 weeks. At the end of this period, patients will be evaluated with breathing, allergy,          and blood tests, as well as questionnaires. Patients will also provide a sputum sample.        -  Phase 2: Patients will receive regular doses of either pioglitazone hydrochloride or a          placebo for 16 weeks. Patients will return to the National Institutes of Health every 4          weeks for tests.        -  Phase 3: Wash-out period without study drugs for 4 weeks, similar to Phase 1.        -  Phase 4: Patients will receive regular doses of either pioglitazone hydrochloride or a          placebo for 16 weeks. Patients who received placebo will be given the study drug, and          vice versa. Patients will return to the National Institutes of Health every 4 weeks for          tests.        -  Phase 5: Medications will be stopped, and patients will return to the National          Institutes of Health 4 weeks later for final tests.   "
239502|NCT00994188|"     Approximately 30,000 new patients are introduced into dialysis and about 20,000 of them die     every year in Japan. At present, about 300,000 patients are on dialysis and more than 10,000     patients are registered with the Japan Organ Transplant Network (JOTN) with the hope for a     renal transplantation. If the renal function is restored by transplantation, the quality of     life (QOL) improves and more than 90% are reportedly comeback to their normal life activities     and get relieved from the burden of dialysis. Furthermore, it can reduce the dialysis related     medical cost by as much as 50%. However, only about 1,000 renal transplantation cases are     annually carried out in Japan. Among them, 80-85% are living renal transplantations offered     by family members or relatives, and the rest are from deceased donors.      Due to the fact that the number of deceased donors are scarce and only living renal     transplantations between the family members or relatives are currently allowed in Japan, the     approximate waiting time to receive a renal transplantation is 16 years. For that reason,     many patients travel abroad to receive a renal transplantation.      There are reports that total nephrectomies are performed as a treatment for small size (4 cm     or less) renal tumors, renal stones, ureteral tumors and ureteral strictures in many cases     and that many of these nephrectomized kidneys can be successfully transplanted after surgical     restoration with satisfactory results. However, due to the lack of necessary evidence it is     currently not allowed in Japan.      Therefore, the investigators planned the present clinical study to evaluate the curative     efficacy (renal function, QOL) and safety (side effects, complications or occurrence of renal     cancer) of living renal transplantations between family members and relatives with restored     donor kidneys after the surgical removal or repairment of a small size (4 cm or less) renal     tumor or renal stone, ureteral tumor or ureteral stricture, in order to acquire necessary     clinical data for potential enrichment of the renal donor pool in Japan as well as to develop     useful medical care for our patients who are on dialysis for many years due to the renal     failure.   "
239503|NCT00994201|"     The purpose of this study is to see if new techniques of measuring HNSCC tumors with magnetic     resonance imaging (MRI) can help predict how well the tumors will respond to combined     chemotherapy and radiation treatment. The investigators hope to find a reliable method to     determine whether or not a patient's cancer is responding to chemo-radiation early in their     treatment using an MRI, such that that cancer treatments could be tailored to the individual     more effective in the future. The MRI techniques include dynamic contrast-enhanced magnetic     resonance imaging (DCE-MRI), diffusion-weighted magnetic resonance imaging (DW-MRI), and     magnetic resonance spectroscopy (MRS). Participants will be subjected to two sessions of MRI     scans: one before the initiation of their regular treatment and the second before their     second cycle of chemotherapy. Each scanning session will last approximately 45 minutes.   "
239504|NCT00994214|"     The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin)     injections at different doses of BIM 23A760 on growth hormone and insulin-like growth     factor-1 levels in patients with acromegaly after 6 months of treatment.   "
239505|NCT00994227|"     this study is to analyze and compare the ultrastructure of the retinal and vitreous plane of     the epiretinal membrane and internal limiting membrane removed during macular surgery and to     evaluate relation between the ultrastructure of the epiretinal membrane and internal limiting     membrane and surgical outcomes.   "
239506|NCT00994240|"     This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin     (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no     controls. Subjects meeting eligibility criteria are randomly divided into one of two     treatment groups (ED&C x 1 cycle or ED&C x 3 cycles) using computer generated random numbers.     One cycle of ED&C is defined according to standard technique currently employed. It involves     scraping away the tumor with a curette (ring- shaped instrument) and then burning the     curetted site with a small electric needle (electrodessication). During Visit 1, the surgical     site is marked, local numbing medication is injected, and 1 or 3 cycles of ED&C is/are     performed by board-certified dermatologists or a dermatology resident under the direct     supervision of a board certified dermatologist. All follow-up visits (3, 6, 9, and 12 months     after Visit 1) include skin evaluations by the physician who performed the ED&C. The lesion     site is examined, measured, and photographed for clinical evidence of recurrence, as defined     by a new lesion within the previously treated site. If there is evidence of possible tumor     recurrence at the treated surgical site during Visit 2, 3, 4 or 5, then the lesion will be     biopsied using a shave procedure.   "
239510|NCT00994292|"     The purpose of this study is to evaluate the safety and efficacy of various doses of YM150     (the experimental drug) in the prevention of ischemic vascular events in subjects with recent     acute coronary syndromes.   "
239511|NCT00994305|"     Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of     deceased renal transplant patients.   "
239512|NCT00994318|"     Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using     targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic     kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).   "
239513|NCT00994331|"     The Stereotaxis Niobe® II Magnetic Navigation System (MNS) is designed to direct and     digitally control catheter and guidewire based therapeutic and diagnostic devices along     complex trajectories within the heart and coronary vasculature.      Navigation using vectors acquired from the CT Co-registration feature of Navigant™ provides     clinical benefits for percutaneous coronary intervention (PCI) by decreasing the amount of     contrast used during complex PCI procedures.   "
239514|NCT00994344|"     The purpose of this study is to determine the non-inferiority in the efficacy of DRV/r     (900/100 mg) monotherapy at 48 weeks versus LPV/r (400/100 mg) as simplification strategy in     subjects with sustained viral suppression on stable PI or NNRTI-antiretroviral regimens.   "
239515|NCT00994357|"     The purpose of the study is to investigate the effects of Real-time Continuous Glucose     Monitoring on severe complications to pregnancy in women with diabetes.   "
239516|NCT00994370|"     This study is being done to investigate the influence of giving radiation to the liver on     tumors involving the liver. Investigator is specifically looking at this effect on the blood     vessels within the tumor. This effect will be measured by studying substances in the blood     that the tumors produce and that cause blood vessels to grow. The effects seen on these     substances may help design other treatments to improve the results of the radiation used to     treat these tumors.   "
239517|NCT00994383|"     Characterize the steady-state pharmacokinetics of morphine after oral administration of     Roxane Laboratories' morphine sulfate immediate release tablets and oral solution and to     compare their pharmacokinetics to that of AVINZA.   "
239518|NCT00994396|"     The investigators' project will study the effects of optimizing the vit D status of obese     adolescents on markers of glucose metabolism and inflammation.   "
239519|NCT00994409|"     The objective of this trial is to guarantee a follow-up of all stroke and transient ischemic     attack (TIA) patients. With this follow-up assessment long term effects of therapy and     prevention measures can be detected and monitored. It is part of quality assurance.   "
239520|NCT00994422|"     The purpose of this study is to compare the safety and efficacy of a 0.5% ivermectin cream to     a placebo in subjects infested with head lice when used in an at home environment.   "
239521|NCT00994435|"     Insulin secretion and insulin sensitivity are related with an inverse, hyperbolic function,     the so called disposition index, that shows the critical importance of the ß-cell dysfunction     for the development of T2DM. A consequence of the hyperbolic relationship is that increased     insulin resistance is compensated by up-regulation of insulin secretion, as it happens in     obesity. However, when a defective insulin secretion in relation to insulin sensitivity takes     place (i.e. reduced disposition index) then impaired glucose tolerance or type 2 diabetes     develop. The investigators have recently demonstrated that bilio-pancreatic diversion     determines a prompt reversibility of T2DM by normalizing peripheral insulin sensitivity and     enhancing ß-cell sensitivity to glucose; these changes occur within few days after surgery,     largely before changes in body weight occur. This operation may affect the entero-insular     axis function, by diverting nutrients away from the proximal gastro-intestinal tract and by     delivering incompletely digested nutrients to the ileum, thus abnormally stimulating the     secretion of intestinal incretins. It has been shown that male Wistar rats undergoing three     different types of small intestinal surgery, namely ileal transposition (either 10 or 20 cm     of lower ileum transposed to mid-duodenum) or 85% jejuno-ileal bypass, showed a sustained     post-operative reduction in food intake and a significant change in body weight gain. All     experimental groups had a large increase in basal and meal-stimulated enteroglucagon, while     the area under the curve of plasma levels of gastrin, gastric inhibitory polypeptide (GIP),     insulin and blood glucose were significantly reduced. GIP is produced mainly in the duodenum     and jejunum as shown in dogs .The aim of the present study is to investigate the intestinal     site of production of incretins in response to intraluminal nutrients stimulation in order to     establish the relationship between insulin resistance, insulin hypersecretion and different     small intestinal segments in insulin resistance conditions, such as obesity and T2DM. To this     purpose a mixed test meal will be infused in the duodenum, proximal jejunum or ileum and     glucose uptake and insulin secretion studied, in relation to glucagon and incretin response.     Studies are carried out in 20 obese subjects of both sexes, 10 of whom with type 2 diabetes     and 10 with normal glucose tolerance.   "
239522|NCT00994448|"     Dr Keith Heinzerling, who is a doctor at UCLA, is doing a research study with Behavioral     Health Services in the Lincoln Heights neighborhood of Los Angeles to find out if a     medication called bupropion can help adolescents (age 14-21) reduce or stop using     methamphetamine. Bupropion is a drug that is already on the market, which means it has been     approved by the FDA, but it has not been approved to treat methamphetamine abuse. What the     study is trying to find out is if bupropion helps people to stop using methamphetamine. The     study lasts up to 14 weeks and involves visits to the BHS clinic in Lincoln Heights twice a     week. The first two weeks involve completion of questionnaires and assessments, including a     physical exam, a blood test, EKG (a test that checks for problems with the electrical     activity of a person's heart), and a psychological interview, to see if you are eligible for     the study. If you are eligible, then you will be assigned by chance to take either the     bupropion pills or placebo pills, which are pills that look the same, but contain no     medication. This type of study is called a double blind study because neither you nor any     of the study staff will know which medication you are taking. During the 8 weeks of taking     the pills, you'll visit the clinic to complete additional questionnaires and assessments, to     provide urine samples for testing for methamphetamine, and for once a week drug abuse     counseling. At the end of your treatment, you'll have another physical exam including blood     tests and the same test on your heart and then we'll ask you to come to the clinic once a     week for four weeks for follow-up assessments. You'll be compensated for time spent doing     research activities and for returning empty medication packages. The total compensation     possible is $332 in gift cards for places such as Target, iTunes, groceries, and gas.      Your participation in the study is voluntary and deciding not to participate or deciding to     stop participating at any time during the study is okay.   "
239524|NCT00994474|"     We previously published a comparative split-face study which has shown a significant, albeit     moderate, effect of ablative fractional laser treatment. While indicating that a single     session with fractional ablative lasers can be effective in the treatment of peri-orbital     wrinkles, the trial also revealed substantial disagreement between the different end points     (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a     patient-related index it could not be included in the aforementioned split-face trial; the     present study therefore attempts to further elucidate the patient-related benefit of a single     fractional ablative laser treatment session as well as carefully analyse the respective     correlations between the outcome parameters employed.   "
239595|NCT00995410|"     This study uses an open-label design and will be conducted in approximately 40 sites in the     United States. Approximately 400 subjects will be enrolled in the study to ensure that     approximately 300 subjects will have 6 months exposure to PA32540 and at least 100 subjects     will have 12 months exposure to PA32540.   "
239525|NCT00994487|"     The purpose of this study is to compare female, preschool-aged children breastfed during     infancy to female, preschool-aged children bottle-fed during infancy in their ability to     adjust calorie intake in response to internal signals of hunger and fullness. Children and a     parent will come to two sessions, with the children given drinks that are either high or low     in energy, and then consume a lunch following the drink. The parent will be present during     the lunch. Greater ability to self-regulate intake is demonstrated when less energy is     consumed at lunch following the high energy drink as compared to the lunch following the low     energy drink. Lunches will be videotaped so that parental feeding styles (i.e., how the     parent interacted with the child during lunch) can be examined. The primary hypotheses are:     1.) the exclusively breastfed children will have higher self-regulation ability than the     exclusively bottle-fed children, and 2.) the mothers of the exclusively breastfed children     will demonstrate a parental feeding style characterized by less control and restriction than     the mothers (or parent primarily responsible for child feeding) of the exclusively bottle-fed     children.   "
239526|NCT00994500|"     This phase I trial is studying the side effects and best dose of vorinostat when given     together with bortezomib in treating young patients with refractory or recurrent solid     tumors, including CNS tumors and lymphoma. Vorinostat and bortezomib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow     to the tumor.   "
239527|NCT00994513|"     The major objective of this study is to conduct a double-blind, placebo-controlled,     randomized clinical trial to assess whether oral alpha lipoic acid supplementation will     decrease cardiovascular disease and type 2 diabetes risk in obese subjects.   "
239528|NCT00994526|"     Colorectal cancer kills forty five people in France every day. Epidemiological studies     suggest that two cases out of three could be prevented and show that processed meat intake is     a consistent risk factor. The aim of this study is to understand how meat promotes cancer, to     find protective strategies, and to make compelling dietary recommendations.   "
239529|NCT00994539|"     Establish the dose proportionality of the 15 mg and 30 mg morphine sulfate tablets and to     examine the effect of food on absorption from the 30 mg tablet.   "
239530|NCT00994552|"     This study is looking at whether there is a difference in outcomes using two different types     of breathing support in those patients who have chronic respiratory failure (patients who     under-breathe).      There is little data to demonstrate which mode of ventilation is better in terms of     physiological outcomes and outcome data relating to patient symptoms.      We hypothesize that one type of breathing support: pressure support ventilation would be more     comfortable for patients as it more closely matches a patient's own respiratory pattern and     and so leads to improved adherence and consequent improvement in quality of life.      Patients with respiratory failure will be randomly assigned to receive either pressure     support ventilation or pressure control ventilation for the first 6 weeks and then cross-over     to receive the mode not previously used for a further 6 weeks. They will have baseline data     recorded and then be followed up after each 6 week block.   "
239531|NCT00994565|"     The CoAct study is investigating a novel lifestyle intervention, aimed at the working     population, with daily activity monitoring and distance counseling via telephone and secure     web messages. The main purpose of this study is to evaluate the effectiveness of lifestyle     counseling on the level of physical activity in an occupational health setting. The purposes     include also analyzing the potential effects of changes in physical activity on productivity     at work and sickness absence, and health care costs.   "
239532|NCT00994578|"     The overall goal of this study is to improve communication between patients with advanced     cancer and their oncologists. A web-based communication intervention will be delivered to     patients to help them to express their negative emotions and elicit empathic responses from     their oncologists.      The specific aims are to:      AIM 1: Develop a web-based intervention that trains patients with advanced cancer to express     their emotional concerns to their oncologists and to request emotional support during     clinical encounters.      AIM 2: Test whether this intervention can increase patient expression of emotional concerns     and requests for emotional support, as well as improve patient affect by decreasing negative     emotions.   "
239533|NCT00994591|"     Levels of cotinine, a biomarker for nicotine, have been found to be higher in infants and     small children than adults. This pharmacokinetic study is designed to determine whether     children metabolize cotinine differently than adults.      Seventy-two healthy children between the ages of 2 months and 6 years will come with their     mothers to SFGH GCRC for one approximately 9 hour visit. After being examined by a     pediatrician, the child will be administered one dose of cotinine at .05 mg/kg.      Saliva and urine samples will be collected prior to dosing and throughout the day to     characterize the metabolism and excretion of cotinine. The investigators have previously     shown that a ratio of 3'-hydroxycotinine/cotinine (3HC/Cot) in saliva correlates closely to     nicotine metabolism.      Following these one day hospital visits, a research assistant will visit the participants in     their homes to collect urine and saliva samples at 1,2,3,7, and 10 days after the initial     dose.   "
239534|NCT00994604|"     The purpose of this study is to examine whether broccoli sprout extract can effect lung     function measurements in individuals with asthma and COPD.   "
239535|NCT00994617|"     To test whether the current custom of initiating treatment for hypertension with a single     drug is less effective in the short-term than initial combination therapy, and results in the     eventual need for comparatively more antihypertensive drug therapy.   "
240585|NCT01004419|"     The purpose of this study is to evaluate the safety and tolerability of vandetanib and     fulvestrant; to find the maximum tolerated dose of these two drugs; and to evaluate response     rate and assess toxicity of this combination.   "
239536|NCT00994630|"     The purpose of this study is to determine expression of chaperones proteins from the     endoplasmatic reticulum stress response system in bipolar I patients (manic phase) compared     to healthy controls.      Hypothesis: There is no difference in chaperones proteins expression between bipolar I manic     patients and healthy controls   "
239537|NCT00994643|"     This is a study to see if maintenance therapy with low dose interleukin-2 (IL-2) and     rituximab can delay or prevent recurrences in patients with high risk Non-Hodgkin's Lymphoma     (NHL). IL-2 is a naturally occurring cytokine in our immune system which may enhance the     activity of a known therapeutic agent rituximab, a monoclonal antibody against CD-20, in the     setting of NHL.   "
239538|NCT00994656|"     Spine fusion is an involved procedure during which patients are at risk for significant     intra-operative blood loss.This study will compare 2 ways of determining fluid status and     response to fluid administration. One way is to measure the changes in the arterial wave form     from the special IV that is usually placed in an artery (PPV). The second way is to use a     non-invasive method of a finger probe that measures changes in the plethysmogram or the pleth     variability index (PVI). No actual patient treatments will be based on these values during     surgery.   "
239539|NCT00994669|"     The long-term objective of this research is to develop a non-invasive approach for early     assessment of which patients are at high risk for future development of skeletal muscle     atrophy. The investigators hypothesize that the rate constant for the terminal portion of the     isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine     (D-3MH) provides an accurate measure of this increased risk and that this rate constant can     be measured non-invasively from timed spot urine samples. In addition, the investigators     hypothesize that ingestion of a meat-containing meal will stimulate synthesis of skeletal     muscle proteins to a greater extent than a non-meat-containing meal.   "
239540|NCT00994682|"     Obesity and Type 2 diabetes are creating a silent epidemic, Non-alcoholic fatty liver     disease, which is a chronic liver disease associated with insulin resistance, impaired     glucose intolerance, and hepatic fat accumulation. The thiazolidinedione pioglitazone     improves glucose/lipid metabolism and histology in NASH by improving insulin resistance in     the liver/peripheral/adipose tissues and reducing subclinical inflammation. The aim of this     study is to assess the underlying mechanisms at the clinical and molecular level and the     long-term efficacy and safety of pioglitazone in NASH in a multiethnic cohort of subjects     (predominantly Hispanics, Caucasians and African-Americans - the most common ethnic groups     locally) and examine the response including patients with normal glucose tolerance, impaired     glucose tolerance or established type 2 diabetes mellitus (T2DM).   "
239541|NCT00994695|"     Primary objective:      To assess the immunogenicity of the Mencevax ACW135 polysaccharide vaccine at 28 days     (+6days) post vaccination in 2-4, 5-14, 15-29 year age groups and compare the immunogenicity     between these age groups.      Secondary Objectives:        -  To estimate the incidence of common adverse events following immunization (AEFI) of GSK          Nm ACW135 polysaccharide vaccine at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination        -  To assess the persistence of antibody against meningitis A, C and W135 at 11 and 23          months post vaccination in 2-4, 5-14, 15-29 year age groups      Study site:Two rural communities (Kebele) in Butajira district, Ethiopia.      Methods:        -  Phase II, open and parallel safety and immunogenicity trial.        -  234 younger children (2-4 years), 145 older children (5-14 years) and 33 adults (15-29          years of age) were randomly selected from the demographic surveillance database and          enrolled after screening and consenting.        -  Study participant received Mencevax ACW polysaccharide vaccine 50 mg in 0.5ml          subcutaneously.        -  Blood samples for measuring SBA titres were collected at pre vaccination and on day 28          (+6 days) post vaccination.        -  Active follow up for AEFI on post vaccination day 0, 1, 2, 3, 7, & 28.        -  Primary end point was vaccine response defined as sero-conversion (in subjects initially          seronegative) or a 4 fold increase (in subjects initially seropositive) in serum          bactericidal antibodies (SBA) against serogroups Men A, C and W135) on post vaccination          day 28. In addition seroconversion was assessed by ELISA Men A IgG on day 0 and day 28          post vaccination.        -  Secondary endpoints were incidence of general and local symptoms and other adverse          events following immunisation during the post vaccination period day 0 to 28 and immune          persistence on post vaccination month-11 and month-23.      Results:        -  No significant difference in the incidence of general or local AEFI was observed between          the age groups        -  The statistical analysis for the Immunogenicity data is in progress   "
239542|NCT00994708|"     Evaluate the prevalence of bronchial responsiveness (BHR) among patients with     gastroesophageal reflux disease (GERD).      Investigate correlation between bronchial reactivity and the severity of GERD, and similarly     investigate the correlation between exhaled nitric oxide (NO) and the severity of GERD.      Compare the effects of esomeprazole 40 mg twice daily and Nissen fundoplication on bronchial     reactivity, exhaled NO, pulmonary function and quality of life.   "
239543|NCT00994721|"     Study Design： Adjuvant gemcitabine therapy has been shown to improve recurrence-free survival     in pancreatic cancer underwent curative intent resection. This study is to evaluate whether     combining concurrent chemo-radiotherapy can further improve the recurrence-free survival     benefit of adjuvant gemcitabine chemotherapy in pancreatic cancer underwent curative     resection.      Research Objective and Study End Points        1. Primary endpoint： The primary end point is disease free survival.        2. Secondary endpoints： The secondary end points are to evaluate the overall survival,          local and distant recurrence rate, and impact on quality of life after adjuvant          gemcitabine with or without CCRT in curatively resected pancreatic cancer.      Furthermore, the clinical, pathological and molecular prognostic factors in curatively     resected pancreatic cancers will be evaluated.   "
239544|NCT00994734|"     The primary aim of this study is to assess the acceptability of home-use mifepristone for     termination of pregnancy among women who choose it and their providers. The investigators'     secondary aims are to assess rates of follow-up, adherence, efficacy, complications, lost     productivity, and to estimate the minimum proportion of women who choose home-use over clinic     use of mifepristone.   "
239576|NCT00995163|"     The MBD-5D is a prospective observational study with a case-cohort and a cohort design.     Eligible patients are receiving hemodialysis and have secondary hyperparathyroidism. The     study's three goals are (1) to record the patients' characteristics, and variation in the     patterns of their treatment; (2) to analyze factors associated with variation in those     medical practice patterns; and (3) to identify practice patterns and other factors that     affect hospitalization, mortality, and other patient-level outcomes.   "
239577|NCT00995176|"     Approximately 30 percent of new HIV infections in the Unites States occur in women, with a     disproportionate number occurring in women of color. This observational study has been     designed to help determine the HIV incidence among women in the study communities as well as     to identify steps that women can take to lower their HIV-infection risk.   "
239578|NCT00995189|"     The purpose of this study was to clinically evaluate the potential causes of contact     lens-related dry eye.   "
239594|NCT00995397|"     Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by     mast cells in the skin. Topical anti-histaminics can be used to promote relief of these     symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation     approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the     ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority     of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the     standard preparation (1% cream) for the relief of insect bite related symptoms and to     demonstrate the safety of both preparations.   "
239596|NCT00995423|"     The purpose of this study is to assess whether the outcome of treatment with CoroflexTM     Please stent is not inferior to the outcome of treatment with TAXUS stent.   "
239545|NCT00994747|"     Flavor is the primary dimension by which young children determine food acceptance. However,     children are not merely miniature adults since sensory systems mature postnatally and their     responses to certain tastes differ markedly from adults. Moreover, emerging research has     revealed that there are sensitive periods during infancy such that early flavor experiences     serve to modify later responses to flavors and foods. The proposed study aims to investigate     this important issue by using as a model system a class of infant formulas which are     hydrolyzed protein based and thus have very pronounced and distinctive flavors which are     unpalatable to older-aged infants and adults. This research was initiated because of     anecdotal reports by pediatricians that although it is easy to introduce this type of formula     to infants during the first months of life, it becomes extremely difficult to do so later in     infancy. Indeed, recent studies in the investigators' laboratory provided the first     experimental demonstration that infants younger than 4 months of age willingly accept     substantial amounts of, and satiate while feeding, a novel, protein hydrolysate formula. In     marked contrast, infants older than 4 months reject the protein hydrolysate formula and this     rejection occurs within the first minute of a feed, a finding that strongly suggests the     sensory qualities of the formula are responsible, at least in part, for this rejection.     Moreover, this rejection is not evident when the investigators test older-aged infants with     other unfamiliar, but non-hydrolysate, formulas. In other words, the rejection appears to be     in response to a particular component or components of protein hydrolysate formulas. This     shift in acceptability can be ameliorated by prior exposure. That is, if these formulas are     introduced to infants within the first few months of life and are fed continuously, they     remain highly acceptable throughout infancy and early childhood. These observations implicate     a sensitive period during development, occurring somewhere before 4 months of age, during     which exposure to a formula, which is unpalatable to adults and infants over 4 months of age     without exposure, renders it acceptable and presumably palatable. To the investigators'     knowledge, this is the clearest example of a sensitive period in the development of responses     to foods and flavors in humans thus far identified.      There is a paucity of information on whether and how the composition of formulas fed to     infants influences their short-term feeding behaviors during the first few months of life.     The primary objective of this longitudinal study is to determine the period during early     infancy when exposure to the casein-hydrolysate formula, Nutramigen, renders it acceptable     during later infancy. The study also aims to determine how early sensory experiences with     formula impact upon food acceptance during infancy (8-9 months of age) and childhood. The     investigators will also explore how variation in the genes that encode for taste receptors     influence preferences for foods and other behaviors.   "
239546|NCT00994760|"     The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in     cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP)     attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study     was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.   "
239547|NCT00994773|"     The investigators have shown robust in vitro anti-hepatitis B activity of simvastatin alone     and synergistic activity with all four FDA-approved anti-hepatitis B oral drugs tested. The     investigators propose phase 1 studies in 48 chronic hepatitis B human carriers who have never     been treated before. Doses of drugs will remain at or below FDA-approved dosage levels for     cholesterol lowering (simvastatin) or hepatitis B (tenofovir or entecavir). Arm 1 will have     simvastatin monotherapy only. Arm 2 will combine simvastatin with tenofovir. Arm 3 will     combine simvastatin with entecavir. For maximum safety, the 3 arms and the dose groups in     each arm will be filled consecutively and not concurrently. The definition of efficacy for     simvastatin alone will be a 1 log drop of hepatitis B virus in 14 days. Efficacy for     combination of drugs will require a 2 log drop of hepatitis B virus in 14 days. Numerous     safety tests and stop rules are noted in the protocol.   "
239548|NCT00994786|"     This study will examine the efficacy of pregabalin (Lyrica) added to SRI treatment in OCD for     individuals who have not responded or only partially responded to an adequate trial of SRI.     Although SRIs have demonstrated efficacy in OCD in numerous placebo-controlled trials,     response rates have been as low as 40%. Augmentation strategies would be beneficial to     maximize treatment response in OCD.      Pregabalin (Lyrica) is an anticonvulsant medication that appears to have a novel mechanism of     action. It has been shown to enhance activity at gamma-amino-butyric acid (GABA) receptors as     well as inhibit glutamate release. These two neurotransmitters systems have been implicated     in the neurobiology of OCD.      The study will consist of patients who have not attained full response to an SRI. The     patients will be randomized in a double-blind fashion to augmentation with pregabalin     (Lyrica) or placebo. The dose of study medication will be flexible, starting at 75 mg/day and     increasing in 75 mg increments to a maximum of 600 mg/day, based on efficacy and any side     effects. Patients' response to treatment will be measured by the Yale-Brown     Obsessive-Compulsive Scale (Y-BOCS), the Montgomery Asberg Depression Rating Scale (MADRS),     and the Clinical Global Impression Scale(CGI).   "
239549|NCT00994799|"     This study investigates the hypothesis that ranibizumab injection given into the eye is an     efficacious and safe treatment option applied for swelling of the macula (site of sharp     vision) in diabetes.   "
239550|NCT00994812|"     The purpose of this study is to determine whether metformin may improve pregnancy rates, and     decrease miscarriage rates and complications of pregnancy, such as toxemia and gestational     diabetes, in women with polycystic ovary syndrome (PCOS).   "
239551|NCT00994825|"     Low cardiac output syndrome (LCOs) is a serious complication in critically ill patients or     those undergoing major surgery, resulting in multiple organ damage with significant     in-hospital and long-term morbidity and mortality, as well as prolonged hospital stay. In     this setting the mortality rate is distressingly high despite improvements in intensive care     treatment, but survivors have an acceptable quality of life.   "
239552|NCT00994838|"     The purpose of this study is to measure the effect of a reduced calorie diet intervention in     new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin     resistance.   "
239553|NCT00994851|"     Primary Objective:      To evaluate the clinical efficacy of Naturetti (capsules) , considering the following     criteria:        -  Evacuation frequency during the treatment and follow-up period        -  Consistency of stools during the treatment and follow-up period        -  Global evaluation, regarding increase in frequency of evacuation and shape of stools.      Secondary Objective:        -  Number of days without evacuation        -  Proportion of evacuation with pain        -  Proportion of evacuation with strain        -  Proportion of evacuation with incomplete sensation        -  Proportion of blocked stools        -  Proportion of manual maneuvers to facilitate defecation        -  Proportion of subjects that adhere to the diet recommended        -  Proportion of the patients who have to use rescue medication        -  Level of constipation improvement, according to the patient evaluation        -  To evaluate clinical tolerability of the study medication by the continuous use        -  To evaluate the occurrence of adverse events related to the study drug        -  To identify any drug interaction.   "
239554|NCT00994864|"     The primary working hypothesis is that preoperative chemo-sensitivity testing using     fluorodeoxyglucose positron emission tomography (FDG-PET) performed before and after one     course of FOLFOX (folinic acid, fluorouracil, oxaliplatin) can identify the patients that     will least likely have a significant benefit from adjuvant FOLFOX for stage III colon cancer.     The benefit will be analyzed by correlating the preoperative FDG-PET uptake changes to the     disease free and overall survival.   "
239555|NCT00994877|"     Methods:      The study is an observational prospective trial that includes 150 patients 18 or older     admitted to our icu because of severe sepsis or septic shock as defined by the American     College of Chest Physicians/ Society of Critical Care Medicine consensus conference.      Patients whose primary reason for hospital admission is sepsis or patients developing sepsis     after elective invasive procedure will be included.      Only patients with known former primary coagulation/hypercoagulability disorder wil be     excluded.      Procedure:      Within 12 hours of admission to the intensive care unit (ICU) blood will be drawn for the     following:      Blood count, glucose, urea, creatinine, liver function tests, prothrombin time, partial     thromboplastin time, Ddimer, fibrinogen and TEG (thromboelastography) assay will be     performed.      These blood tests will be also drawn on day 2 and 4 of admission. On day one, another 3 cc of     blood will be drawn and frozen in -80 degrees for levels of coagulation factors: I, II, V,     VII, VIII, IX, X, XI, XII, XIII, Antithrombin III, protein C, S.      Demographic data will be collected according to patient chart, and the acute physiologic and     chronic health evaluation (APACHE) II score will be assessed after 24 hours. Vital signs will     be collected from monitors.      Informed consent will be waved due to lack of any intervention and the general condition of     patients unable to sign an informed consent.      Control group will include 10 healthy individuals.      End point:      The primary end point is to determine the common hypercoagulable/coagulation disorders     according to TEG.      The secondary end point is to determine whether TEG results have prognostic implications on     this group of severe septic patients.   "
239556|NCT00994890|"     This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg,     and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times     during the study treatment period.   "
239557|NCT00994903|"     Statins (HMG-CoA reductase inhibitors) are a widely used class of cholesterol-lowering drugs     that have an established role in the medical management of cardiovascular disease. Their     benefits have also been shown in the surgical setting with decreased cardiovascular     complications and lower perioperative mortality following cardiac and vascular surgery. There     is now considerable evidence showing statins have useful pleiotropic properties that extend     beyond cholesterol lowering, including anti-inflammatory, anti-oxidant, immunomodulatory and     fibrinolytic effects. Growing evidence suggests these effects may be useful in attenuating     the proinflammatory and metabolic stress response to surgery and the benefit of statins may     extend to other surgical settings such as abdominal surgery.      Laboratory studies demonstrate the surgically-relevant benefits of statins and show they     decrease peritoneal inflammation, reduce the severity of intestinal ischaemia-reperfusion     injury, improve survival in models of abdominal sepsis, decrease the formation of     postoperative intraperitoneal adhesions and improve the healing of colonic anastomoses.     Retrospective clinical studies show statins improve outcomes in sepsis, reduce the     postoperative systemic inflammatory response syndrome (SIRS) and are associated with     decreased rates of surgical wound infections and postoperative respiratory complications     following various non-cardiac general surgical procedures. However, no prospective studies     have specifically evaluated the perioperative use of statins in abdominal surgery. Using     colorectal surgery as a model for major abdominal surgery, the investigators will conduct a     randomised controlled trial evaluating the effect of perioperative statin use on     postoperative morbidity, local and systemic inflammatory response, and functional recovery     after surgery.   "
239558|NCT00994916|"     The purpose of the study is to provide expanded access (compassionate use) of 3,4     diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).   "
239559|NCT00994929|"     The purpose of this study is to determine the biologic efficacy and safety of rhIL-11 when     given subcutaneously in adults with moderate or mild hemophilia A or Von Willebrand disease     unresponsive to DDAVP. Biologic efficacy will be measured by the number and percent increase     of VWD coagulation tests (FVIII:C, VWF: Ag, VWF: RCo, closure time, APTT, and VWF multimers)     to the normal range, or at least to 1.5-3 time baseline, following dosing of rhIL-11 when     given daily for 4 days, and boosted by DDAVP infusion on day 4, in those in whom DDAVP is not     contraindicated. Safety will be measured by the frequency of adverse events, including fever,     headache, fatigue, myalgias, arthralgias, fluid retention, or edema.   "
239560|NCT00994942|"     Determine the pharmacokinetics and optimize study design for subsequent studies with morphine     sulfate tablets and solution.   "
239561|NCT00994955|"     Selective Retina Therapy (SRT) is an effective and safe laser treatment of clinically     significant diabetic macular edema which targets the retinal pigment epithelium while sparing     the neurosensory retina.   "
239562|NCT00994968|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide,     docetaxel, and S-1, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving more than one drug (combination     chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed.      PURPOSE: This phase II trial is studying giving doxorubicin hydrochloride together with     cyclophosphamide, docetaxel, and S-1 before surgery in treating women with stage II or stage     III breast cancer.   "
239563|NCT00994981|"     The purpose of this study is to evaluate the effect of intravenous magnesium infusion before     reperfusion with employing some clinical parameters including blood lactate levels, because     the intraoperative changes in the blood lactate levels after hepatic allograft reperfusion     served as an accurate predictor of the initial graft function in living donor liver     transplantation.   "
239564|NCT00994994|"     Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery.     Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict     results. The reason why they showed mixed results would be the imbalance of patients     population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric     cardiac surgery with well balanced patients population.   "
239579|NCT00995202|"     RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA     assessment, may help monitor a patient's response to surgery. It is not yet known which     follow-up regimen is more effective in patients who have undergone surgery for colorectal     cancer.      PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or     without CEA assessments to see how well they work in patients who have undergone surgery for     stage II or stage III colorectal cancer.   "
239580|NCT00995215|"     Respiratory infections, such as pneumonia and bronchitis, occur frequently in the spinal cord     injured population, due to paralysis of the muscles responsible for coughing. Using spinal     cord stimulation techniques, these muscles can be activated to restore an effective cough     mechanism.   "
239843|NCT00998764|"     The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab     in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over     250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each     subject's participation will last approximately 4 years.   "
239565|NCT00995007|"     Background:        -  Growth of new blood vessels (angiogenesis) provides many tumors, including brain tumors,          with needed nutrients and oxygen for cancer cells to survive. One possible treatment for          different kinds of cancer involves treatment with drugs that slow or stop angiogenesis          and prevent further tumor growth.        -  Vandetanib is an oral medication known to block angiogenesis and has shown significant          antitumor activity in laboratory and animal studies. Vandetanib appears to be well          tolerated by patients at specific daily doses.        -  Carboplatin is a drug that interrupts division of cancer cells and has been shown to be          a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating          brain tumors, but researchers are interested in gathering more information about how it          works as a treatment for patients who have not responded to initial surgery, radiation,          or chemotherapy.      Objective:      - To determine the safety and effectiveness of vandetanib and carboplatin, given together or     sequentially, against recurrent high-grade gliomas.      Eligibility:      - Adults diagnosed with a malignant glioma who have received standard treatments that no     longer appear to be effective.      Design:        -  Patients will be assigned to one of two groups. Group 1 patients (combination group)          will receive oral vandetanib for 28 days and intravenous (IV) carboplatin (once at the          beginning of the 28-day cycle). Group 2 patients (sequential group) will receive IV          carboplatin alone (once at the beginning of the 28-day cycle) and then oral vandetanib          (300 mg daily) for 28 days if the tumor grows or the patient develops unacceptable          carboplatin toxicity.        -  Treatment will continue in 28-day cycles for 1 year for both groups.        -  Patients will undergo a number of tests and procedures during the treatment cycle,          including physical examinations, routine laboratory tests, electrocardiograms, and          magnetic resonance imaging (MRI) scans        -  At the end of 1 year of treatment, patients will be reevaluated for possible          continuation of drug therapy.   "
239566|NCT00995020|"     The purpose of this trial is to determine whether SWETZ (Straight Wire Excision of     Transformation Zone) is a superior alternative to LLETZ cone (Large Loop Excision of     Transformation Zone cone biopsy) in the management of pre-invasive endocervical disease.      SWETZ is a new cone biopsy procedure performed with a straight wire electrode and it will be     compared to LLETZ cone, which is performed with a large loop electrode.   "
239567|NCT00995033|"     The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered     with varenicline as an aid in smoking cessation over a one-year period in smokers who want to     quit smoking.   "
239568|NCT00995046|"     Patients with severe haemophilia A lack clotting factor FVIII and suffer from spontaneous and     traumatic bleeds. In the absence of treatment, frequent bleeds in joints lead to severe joint     destruction. In 1960s, prophylactic therapy was developed involving the infusion of clotting     factor on a regular schedule in order to keep clotting levels sufficiently high to prevent     spontaneous bleeding episodes. Prophylaxis is started at an early age before the age of 2     years or after the first joint bleed. The Malmö experience indicates that treatment is most     effective when administered in large doses at least 3 times weekly. However, such an     intensive treatment in young boys may be very difficult to carry out for home treatment.     Currently, there is no international recommendation on prophylactic therapy regimens. Because     of the high cost and limited availability of factor concentrates, dosing is an important     issue in prophylaxis therapy. It was recently shown that 24 hours after FVIII concentrate     administration, in patients presenting similar FVIIII levels, thrombin generation capacity     may be significantly different. In addition, independently of the FVIII level, a correlation     was found between severe clinical bleeding phenotype and thrombin generating capacity. The     aim of the present clinical study is to assess the thrombin generation test as the main     surrogate marker to evaluate the coagulating capacity of haemophiliacs on prophylaxis     regimen. Optimizing prophylactic therapy to patient's phenotype with no loss of clinical     effectiveness can significantly improve patients' quality of life, protect haemophilic     children against arthropathy and possibly limit the cost of the prophylaxis therapy.   "
239569|NCT00995059|"     Rationale: Giving bortezomib and low doses of chemotherapy and total-body irradiation before     a donor stem cell transplant or peripheral blood stem cell transplant helps stop the growth     of cancer cells. It also stops the patient's immune system from rejecting the donor's stem     cells. The donated stem cells may replace the patient's immune cells and help destroy any     remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a     donor can also make an immune response against the body's normal cells. Giving sirolimus and     tacrolimus before and after transplant may stop this from happening.      Purpose: This phase I/II trial is studying the side effects and best dose of bortezomib     before donor stem cell transplant in treating patients with multiple myeloma.   "
239570|NCT00995072|"     Beta-blockers (BB) are an important treatment for high blood pressure and heart disease.     However beta-blockers can cause sexual dysfunction (SD) and this common side effect limits     successful use of this class of medications. Sexual side effects often result in drug     discontinuation, compromising therapy goals. The investigators are conducting the study to     determine if nebivolol, a newer beta blocker that is selective for receptors in the heart and     causes vasodilation in the body causes fewer sexual side effects, or even improves sexual     function, compared with metoprolol succinate.   "
239571|NCT00995085|"     This clinical study is designed to evaluate the safety and tolerability of a single oral     administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD.     Study also assess cognitive effects of such drug administration.   "
239572|NCT00995098|"     There is increasing evidence that indicates early enteral nutrition may be associated with     improved outcome in acute pancreatitis patients. However, most of the clinical trials     regarding this targeted mild to moderated pancreatitis patients. In regard to severe acute     pancreatitis (SAP) patients, current results from randomized control trials (RCTs) are     inconclusive. The researchers of this study aim to investigate the impact of early enteral     nutrition on the clinical outcomes of SAP patients.   "
239573|NCT00995124|"     The purpose of this study is to compare the ovicidal activity of three head lice treatment     products.      The study population will consist of Queensland primary school-aged children (Grades 1 - 7)     who have at least 20 live eggs on the hair and who have not used any head lice product in the     four weeks prior to the study.      Enrollment will continue to achieve 30 subjects in each treatment group (total of 90     subjects).   "
239574|NCT00995137|"     This study will determine the maximum tolerated dose of genetically modified natural killer     (NK) cells in research participants with relapsed or refractory B-lineage acute lymphoblastic     leukemia (ALL).   "
239575|NCT00995150|"     The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing     intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who     request long-term, reversible contraception for up to 8 years.   "
239592|NCT00995371|"     This is a single-center, randomized, prospective, double-blind clinical study to assess the     clinical application and outcomes with MILD® devices versus epidural steroid injection in     patients with symptomatic moderate to severe central canal spinal stenosis.   "
239581|NCT00995228|"     Peri-operative fluid therapy is a controversial area with few randomized trials to guide     practice. Fluid management has a significant influence on outcome following surgery. Yet     practically, fluid prescription practice during this period is sub-optimal, resulting in     avoidable iatrogenic complications.      Several studies have assessed the effect of a 'liberal' vs. a 'restrictive' perioperative     fluid regimen on post-operative outcome. However, most of these studies have focused     primarily on intra-operative fluid management, whereas postoperative strategies have been     less well defined, even though the immediate postoperative period is of critical importance     to the patient's recovery. Moreover, whereas intra-operative fluid administration is     monitored by the anesthesiologist, postoperatively it is less supervised and may result in     excess or lack of intravenous (IV) fluids. Therefore, fluid management audit at the     post-anesthesia care unit (PACU) is of paramount importance for patient healthcare. The     objective of this study is to follow and report the current practice of fluid administration     in the PACU of Tel Aviv Sourasky Medical Center, for an extended period of time as a first     step towards establishing evidence-based guidelines for postoperative fluid management.   "
239582|NCT00995241|"     The purpose of this study is to compare plasma and intracellular pharmacokinetic parameters     of raltegravir 800 mg administered once daily in HIV infected patients.   "
239583|NCT00995254|"     Second hand smoking (SHS) is a health hazard to infants and children, in whom it is     associated with lower respiratory tract infections, wheezing, cough, middle ear infections     and sudden infant death syndrome. Evidence from developed nations suggests that measures to     reduce exposure to SHS can improve children's health outcomes; this has not been     systematically studied in a developing country setting. The investigators hypothesize that     implementation of a package of smoking hygiene intervention measures delivered by community     health workers (CHWs) will reduce Chinese children's exposure to SHS and improve their     respiratory health.      To test this hypothesis, the investigators have identified three specific aims: (1) to obtain     baseline data on second hand tobacco exposure among young children, health status of young     children and smoking status of parents and other household members, (2) to generate     preliminary effectiveness data for CHW-delivered SHI, and (3) to develop culturally     appropriate biochemical measures to assess children's exposure to household SHS. The     investigators propose to conduct this study in an urban district in Shanghai, China. After an     initial assessment, the investigators will conduct a randomized controlled trial of     households in a community, selected based on important study criteria, within the district.     The investigators selected this design because it is most likely to produce a scientifically     valid answer to our primary study question. All eligible smokers in the intervention group     will receive behavioral counseling to address health hazards of SHS towards children, brief     advice to quit or to adopt a no smoking policy around children, and educational pamphlets on     the hazards of SHS, from a trained CHW in their community. A questionnaire will be used for     data collection at the start and at 2 and 6 months. To assess the extent of total SHS     exposure, children's urine cotinine (the indicator of nicotine) level will be measured at the     first contact and at 2-and 6- months. To validate household members reported level of smoking     the investigators will measure air nicotine levels of a sub-sample (10%) of households via     passive monitors. The results of this study will provide clinical evidence for the     development of CHW-delivered interventions designed to reduce exposure to SHS and improve the     respiratory health of children in a resource-poor community. If successful, the program can     serve as a model for implementation in other developing country settings. Furthermore,     successful results could also be used to draft guidelines for health promotion interventions,     which could be implemented as a policy for all primary health care settings. Finally, the     study, which would be the first of its type in a developing country setting, will form the     basis for future research and program development in the area of SHS.   "
239584|NCT00995267|"     Purpose: In the framework of a randomized concurrent controlled trial, to assess the     effectiveness of a feasible educational mechanism based on the principles of Alfred Adler,     that focuses on the family, to improve the dietary habits of schoolchildren, to induce them     to increase their physical activity, and to prevent obesity and diseases related to obesity.     Primary Objectives for Children: 1.To increase intake of fruits and vegetables, to reduce     intake of sweets and unhealthy snacks at home and in school, to increase exercise and to     reduce sedentary activities. Primary Objective for the Parents: Increase the involvement of     parents in the education of their children regarding nutrition.      Description: Study population: Approximately 600 students and 600 parents from 24 first grade     classes in 4 schools. Schools are randomized into intervention and control groups. The     intervention comprises a 5-session parental workshop and 5 joint parent-child school-based     activities. The control group will be offered the intervention after conclusion of the trial.      Participants are recruited in first grade, anthropometrics are measured, and pupils and     parents are interviewed on eating habits and exercise. Snacks are observed. The intervention     takes place in the second grade, and outcome assessment is done at the end of the 2nd grade     and beginning of the 3rd grade. In-depth interviews will be conducted with parents of obese     children.      Significance: Most interventions geared to prevention of childhood obesity have failed     dismally. A new approach that focuses on the parent-child interaction may be contributory.   "
239585|NCT00995280|"     The aim of this study is to compare whether oocyte flushing during retrieval is effective or     not.   "
239586|NCT00995293|"     The Primary Objective is to evaluate the progression-free survival after treatment with     docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus     5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to     evaluate and compare the clinical response rate both before and after radiotherapy, the local     symptoms, the duration of response, the time to treatment failure, the survival, the toxicity     and the quality of life in the 2 study groups.   "
239587|NCT00995306|"     To evaluate the safety and efficacy of Civamide Cream 0.075% as a treatment of the signs and     symptoms associated with osteoarthritis of the knee.   "
239588|NCT00995319|"     The purpose of this clinical investigation is to evaluate acute and longlasting side effects     in patients undergoing radiotherapy for cancer treatment in the head and neck area.   "
239589|NCT00995332|"     Hypothesis: Combined treatment with valproic acid and ATRA can be used to achieve disease     stabilization for a subset of patients with acute myelogenous leukemia (AML), and this effect     can be improved without serious toxicity by adding low-dose cytarabine to this treatment.      Adult patients >18 years of age who can be included:      Elderly patients who cannot achieve standard chemotherapy, patients with relapsed or     resistant AML.      Treatment: Combined therapy with:      Valproic acid, continuous therapy until disease progression ATRA, oral therapy for 14 days     every three months Low-dose cytarabine 10 mg/m2 up to 10 injections during week 2 and 3,     repeated every 3 months.   "
239590|NCT00995345|"     The purpose of this study is to assess the safety and effectiveness of KRP-104 on glycemic     control in patients with type 2 diabetes inadequately controlled on metformin alone.   "
239591|NCT00995358|"     The purpose of this study is to evaluate overall survival and immunological monitoring for     peptide vaccination therapy using novel cancer testis antigens for locally advanced,     recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).   "
239593|NCT00995384|"     The purpose of this study is to assess the effectiveness of cardiac CT versus TEE in     endocarditis patients.   "
239597|NCT00995436|"     Research problem:      Anchorage reinforcement is effective with headgear provided patient compliance is optimal.     Nance palatal arch have also been shown to be effective. Microscrews despite their popularity     however have no scientific evidence to support their use.      Aim:      To compare the effectiveness of 3 methods of anchorage reinforcement 1) headgear 2) Nance     palatal arch 3) orthodontic micro-screws.      Hypothesis:      There is no difference in the amount of anchorage loss between the three methods of anchorage     reinforcement.      Design:      Randomized clinical trial.      Setting: District General Hospital orthodontic department      Participants: 78 patients requiring absolute anchorage.      Interventions: The subjects will be randomized into 3 groups. In group 1 headgear will be     requested 12-14 hours per day. In group 2 a nance palatal arch will be placed for use as     intra oral anchorage reinforcement. In group 3, orthodontic micro-screws will be used for     anchorage.      Method of investigation:      The study will be of 78 'absolute anchorage' patients older than 12 years randomly assigned     to one of three groups of anchorage reinforcement      Outcome measures:        1. Anchorage loss measured from lateral Cephalometric radiographs and 3-D model scanning,          records will be taken at three points        2. Patient perception of the different treatment methods, including surgical experience      Data analysis: The data will be analysed on an intention to treat basis. Basic descriptive     statistics and uni-variate tests will initially be done to explore the data. Final data     analysis will involve the relevant multi-variate statistical modeling.      Dissemination: Conference proceedings, journal papers and the Cochrane oral health group.   "
239598|NCT00995449|"     The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of     various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who     have had an inadequate prior treatment outcome from biologic therapy.   "
239599|NCT00995462|"     This study assess whether a small-group seminar intervention to prevent weight gain is     effective in a general university student population, and to address the relative role of     biological vs. lifestyle factors in predicting weight gain in humans.   "
239600|NCT00995475|"     Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers     are now an established treatment for COPD. Inhaled steroids can have a number of bad effects     including suppression of the adrenal glands because of absorption. A previous study in     patients with COPD.      C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation.     Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP     have also been found in patients with COPD. In some studies, steroid inhalers have reduced     CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown     whether this reflects a reduction in lung inflammation or an effect of systemically absorbed     corticosteroid.      It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung     inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.   "
239601|NCT00995488|"     This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin     and gemcitabine in the treatment of patients with advanced bladder cancer.      Study participants will have been diagnosed with advanced bladder cancer. Cisplatin based     chemotherapy in this setting has activity but is not curative. Furthermore, patients with     this disease have comorbidities that limit the use of cisplatin based therapy. Combination     paclitaxel, carboplatin and gemcitabine is active and well tolerated in this patient     population.      Paclitaxel is formulated with ethanol and a Cremophor EL (polyoxyethylated castor oil) which     contribute to the side effects associated with paclitaxel. ABI-007 (brand name Abraxane™) is     a form of paclitaxel that does not contain these additives and may deliver more drug to tumor     cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in the     treatment of metastatic (advanced) breast cancer based on superior anticancer effect, and is     being evaluated in other cancers in research studies.   "
239602|NCT00995501|"     Evidence thus suggests that steroid administration, tight glucose control, and avoidance of     deep anesthesia may decrease perioperative morbidity by reducing the inflammatory response to     surgery. Using a three-way factorial approach, the investigators thus propose to test the     primary hypotheses that major perioperative morbidity is reduced by: 1) low-dose     dexamethasone; 2) intensive perioperative glucose control; and 3) lighter anesthesia.      Secondary hypotheses include that each intervention reduces circulating concentrations of the     inflammatory marker CRP, and that there is a correlation between C-reactive protein (CRP) and     post-operative complications. Anesthetic sensitivity predicts major and minor complications,     and delirium Other secondary hypotheses are that each intervention, reduces minor surgical     complications, reduces postoperative nausea and vomiting (PONV), reduces postoperative     delirium, speeds hospital discharge, improves quality of life (SF-12v2 Health Survey,     Christensen's VAS fatigue score), and reduces all-cause one-year mortality.   "
239603|NCT00995514|"     The primary objective of this trial is to demonstrate the non-inferiority of clopidogrel     compared to prasugrel over 6 months in cardiovascular disease patients when the clopidogrel     cohort is limited to the estimated 70% of the population that are CYP2C19 extensive     metabolizers. This protocol will examine the comparative effectiveness of these two     strategies.   "
239872|NCT00999141|"     The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus     standard of care in adhering tissue and improving wound healing in subjects undergoing     facelift.   "
239623|NCT00995774|"     The goal of this project is to develop and test a new robotic system to accommodate practice     of tasks requiring reach, grasp and release of objects. Our previous work has shown that the     MIME robot is safe and effective for improving reach in stroke subjects. But adequate control     of hand movements is critical to a functional upper limb, and is often resistant to     conventional therapeutic interventions. Many stroke survivors have residual ability to flex     the fingers, but extension is often limited and impeded by increased passive stiffness in     flexors, abnormal levels of increased tone in flexors and weakness in extensors. In a recent     study, 38% of stroke survivors reported that impaired hand function was the most disabling     motor impairment they faced.   "
239624|NCT00995787|"     The primary aim of this study is to evaluate the safety and tolerability of AZD1656 in T2DM     patients treated with metformin and sulfonylurea.   "
239625|NCT00995800|"     This is a dose-response study to determine how various measurements of airway inflammation     respond to high and low dose FlutiForm®, and compared to placebo.   "
239604|NCT00995527|"     Background:        -  The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases is conducting          research investigating how the swine flu (H1N1) vaccine affects the immune system. The          exposure to the new swine flu vaccine gives us a rare opportunity to learn about how the          human immune system responds to a new vaccine.        -  Researchers are interested in collecting blood samples from individuals who have          received the vaccine. Participants will be selected from a group of healthy volunteers          who will be receiving the H1N1 vaccine because it is mandatory for their work at the          National Institutes of Health. This protocol will be one of the first studies to          characterize the human innate immune response to H1N1 vaccine.      Objectives:      - To collect blood samples for research purposes before and after participants receive a     standard non-research vaccination against swine flu (H1N1).      Eligibility:        -  Healthy individuals 18 years of age and older who are employees of the National          Institutes of Health.        -  Individuals who have had confirmed cases of influenza in the past year are not eligible          to participate.      Design:        -  Participants will be admitted for a 36-hour inpatient stay, during which blood samples          will be taken frequently. Participants will have a standard intravenous catheter          (similar to the one used for intravenous infusions) put in place to avoid multiple          needle sticks.        -  Participants will be assigned into one of two groups; the two groups differ in the          timing of blood draws but not in the overall amount of blood drawn.        -  Group 1: Blood samples 30 minutes before and immediately before vaccination. Additional          samples will be taken 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 30, and 36 hours after          vaccination.        -  Group 2: Blood samples 30 minutes before and immediately before vaccination. Additional          samples will be taken over the following 36 hours, with exact timing to be determined          based on the findings from group 1.        -  All participants will provide blood samples 7 days after being released from the          inpatient stay.        -  Because of the amount of blood being drawn for research, participants should not donate          blood or take part in any other protocols that collect blood while participating in this          study.   "
239605|NCT00995540|"     INGAP Peptide acetate is the active ingredient of INGAP Peptide Solution for Injection. It is     being developed as an antidiabetic agent for the restoration of endogenous insulin secretion     in patients with type 1 diabetes mellitus (T1DM) and in insulin-deficient patients with type     2 diabetes mellitus (T2DM). This clinical study is designed to generate additional data     regarding the appropriate dose and dosing regimen and to evaluate safety and efficacy in     patients with T1DM.   "
239606|NCT00995553|"     The primary aim of the study is to test the efficacy of a novel cognitive remediation     intervention that targets working memory-related functions. To accomplish this goal, 80     volunteer patients with schizophrenia will be enrolled and randomized to either a cognitive     remediation condition that targets working memory or a computer skills training intervention     that teaches computer applications. In both conditions participants will receive computer     training three times a week for 4 months. The investigators hypothesize that patients who     receive the cognitive remediation intervention will demonstrate significantly greater change     on neuropsychological measures of working memory and executive abilities than patients who     receive the computer skills course. In addition, the investigators hypothesize that the     intervention-induced cognitive change will be associated with concurrent improvements in     functional capacity and psychosocial functioning in the community. A second study goal is to     examine the stability of the intervention-induced changes in cognition. Cognition and     psychosocial functioning will be reassessed 4 and 8 months after treatment termination to     examine the stability of treatment effects and to assess whether a less intense maintenance     training (once a week sessions) provides any additional benefit to participants. Lastly, this     study will examine in an exploratory manner whether there are individual differences in     treatment response. The Val158Met polymorphism of the COMT gene has been found to be     associated with working memory and prefrontal dysfunction in schizophrenia. The study will     test whether the COMT polymorphism is predictive of response to cognitive remediation.   "
239607|NCT00995566|"     The Thelin Patient Safety Registry is a post-marketing program in the European Union (EU)     that is designed to supplement the reporting of spontaneous adverse events (AE) and better     characterize known and potential safety signals for Thelin. The registry is a secure,     restricted access, electronic system which collects anonymous, pre-defined, patient-level     data on demographic variables, safety monitoring measurements (i.e. liver function tests,     haemoglobin and international normalized ratio (INR) measurements), concomitant medications,     information on AEs and Thelin drug discontinuation. Regular review of the data is conducted     to assess the frequency of identified safety risks and to monitor for the emergence of new     safety signals at monthly pharmacovigilance meetings, quarterly signal detection meetings,     and for each Periodic Safety Update Report (PSUR).   "
239608|NCT00995579|"     The purpose of this study was to measure the actual energy expenditure (EE) using indirect     calorimetry for the 10,000 steps goal, and compared to the estimated EE using predictive     equation.   "
239609|NCT00995592|"     Malnourished children and babies with birth weights under 2500 grams are at high risk for     negative outcomes over their lifespan. Philani, a paraprofessional home-visiting program, was     mounted in neighborhoods in three townships in Cape Town, South Africa, from 2002 to 2004 to     improve nutritional outcomes.      One mentor mother was recruited from each of 37 neighborhoods. Mentor mothers were trained to     conduct home visits to weigh children and to support mothers to problem-solve life     challenges, especially around nutrition. Households were randomly assigned on a 2-to-1 ratio     to the Philani program or to a standard care condition. Children were evaluated over a 1-year     period.      The investigators hypothesized that children in the intervention would gain more weight than     children in the control.   "
239610|NCT00995605|"     The purpose of this study is to determine whether AMAP102 is safe and well tolerated by     humans.   "
239611|NCT00995618|"     This is a randomized, double-blind, 3-period crossover phase 2 study in patients with     documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics     (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and     PD as measured by reduction in serum uric acid levels.   "
239612|NCT00995631|"     The typical female pattern of accumulating fat in the hips and thighs has long been thought     to confer less risk for disease than the typical male abdominal fat pattern. However, leg fat     may not simply be benign with respect to disease risk, but may in fact protect against     cardiovascular disease risk. Although the mechanism for this is unknown, the investigators     hypothesize that removing a portion of this important fat depot (via liposuction) could     increase disease risk. Such unfavorable results may or may not be transient depending on an     individual's ability to defend their fat mass. Because sex hormones appear to play a role in     regional fat accumulation, the investigators hypothesize that estrogen-deficient     postmenopausal women may have an augmented abdominal fat accumulation and an attenuated hip     and thigh re-accumulation compared to premenopausal women following lipectomy and compared to     non-surgical controls. As a result, the increased abdominal fat accumulation may worsen     disease risk in postmenopausal women. Menopause-related differences in fat storage at     baseline are also expected to determine the degree to which lipectomy alters disease risk and     the propensity for AT re-accumulation.   "
239613|NCT00995644|"     Smoking cessation can be enhanced either by increasing the success of quit attempts or by     increasing in the number of quit attempts. The investigators are interested in what causes a     smoker to make a quit attempt. The investigators will test whether certain events (e.g., a     request from a child to quit smoking or exposure to a smoking-related health message)     increase the probability of a quit attempt in the near future. The investigators are will     test whether planning behaviors (e.g. seeking information about treatment) and setting a quit     date are common and increase the probability of a quit attempt. Finally, the investigators     want to see if spontaneous, unplanned quit attempts are common and are more or less     successful than delayed, planned quit attempts. In a pilot study, the investigators will     develop measures of the most common events and planning activities. In the main study, the     investigators will recruit 200 adult daily smokers who are interested in quitting in the next     3 months. They will call a phone daily and use the phone's keypad to enter data plus they     will complete mailed or internet questionnaires weekly for 3 months. The results of this     study will a) help us understand what prompts smoking cessation attempts, b) help develop     media messages and individual interventions to motivate smokers to make a quit attempt, and     c) help determine whether spontaneous, impulsive quit attempts or delayed, planned quit     attempts should be encouraged.   "
239614|NCT00995657|"     Asthma is a chronic disease, which means that it cannot be cured, but the investigators can     use inhalers and tablets to control the symptoms. In asthma, the airways become inflamed and     irritated which can cause coughing and make the airways tighten. This 'inflammation' is the     root of the problem in asthma. Doctors have different ways to measure the inflammation in the     airways. One way is to measure a gas called nitric oxide (NO) on the breath. This is made by     the lungs when asthmatic inflammation is present. The investigators have been using NO as a     test in research labs for many years, but there are still unanswered questions about how it     changes between morning and night and how quickly medicines work on it. In most asthmatics,     even small doses of inhaled steroids (preventers) can reduce the NO levels to normal, but in     some people this does not seem to happen. The investigators now have portable NO machines     that are designed for patients to use in the home. The investigators want to follow NO     readings in patients with high levels to measure how they respond to different doses of     steroid inhalers. The investigators hope this will help the investigators better understand     asthma inflammation and treatments.   "
239615|NCT00995670|"     Anesthetic preconditioning (APC, a brief exposure to an anesthetic gas) has become an area of     intense research interest because of its ability to protect tissue and organs from injury     resulting from a cessation of blood flow and then a re-establishment of flow. The blood     vessel lining plays a key role in this injury. This research will examine, in human     volunteers, several important modifiers of APC in human blood vessels: high blood sugar,     vitamin C, and statin drugs. Thus, the proposed studies will advance the investigators'     understanding of mechanisms of this injury in humans and explore important modifiers of APC     protection from injury.   "
239616|NCT00995683|"     The goal of this study is to evaluate the effect of preventive intravenous infusion of half     molar sodium lactate on the onset of hypertensive intracranial episodes in severe head     trauma. The investigators hypothesize that preventive intravenous administration of sodium     lactate will decrease the number of treatments required to decrease intracranial pressure     during 48 hours.   "
239617|NCT00995696|"     This study will assess the effectiveness of a medication safety monitoring method utilizing     interactive voice response technology for youth recently prescribed anti-depressant     medication.   "
239618|NCT00995709|"     The purpose of this pivotal trial is to evaluate subcutaneous (SQ) AIN457 as an adjunctive     therapy to reduce the rate of exacerbations of posterior uveitis or panuveitis secondary to     Behçet's disease during the 24 weeks of study therapy as compared to standard of care alone.   "
239619|NCT00995722|"     The purpose of this study is to evaluate the efficacy and tolerability of prednisone in     patients diagnosed with ocular myasthenia.      Funding Source - FDA OOPD   "
239620|NCT00995735|"     Objectives: Since 2007, natural orifice surgery evolved from theory and animal research to     clinical applications, but is still limited in the literature to small casuistic reports. A     preliminary prospective evaluation of postoperative results of the early casuistic of Natural     orifice Surgery for many indications may show advantages and disadvantages of the methods.     The IMTN Multicenter Trial for Clinical NOTES was and early results are described.   "
239621|NCT00995748|"     The Primary objective of this registry is to assess the control of Atrial Fibrillation (AF)     over one year in patients attending clinical or specialized practices.      The Secondary objectives are:        -  To describe key demographics and treatment features in AF patients visiting          cardiologists in various countries in Asia-Pacific.        -  To establish correlation between control of AF and clinical outcomes.        -  To establish correlation between treatment strategies and AF control.   "
239622|NCT00995761|"     The rationale of phase II study of biweekly docetaxel and cisplatin in patients with     unresectable NSCLC are follows:      First, the optimal dose and schedule of combination with docetaxel and cisplatin are still     controversial (3 weekly versus weekly).      Platinum-based combination chemotherapy improves the survival of patients with advanced     non-small cell lung cancer (NSCLC) in the first-line setting.      Combination chemotherapy with docetaxel and cisplatin is one of the standard platinum-based     regimens for treating NSCLC. However, usual standard 3 weekly regimen with docetaxel and     cisplatin have consistently produced frequent Grade 3-4 neutropenia, and febrile neutropenia.      Although weekly docetaxel and cisplatin is better tolerated than chemotherapy every 3 weeks,     especially in the first line setting in terms of myelosuppression, the optimal dose and     schedule for administration of the two drugs has not yet been determined.      Both 3-weekly docetaxel plus cisplatin and weekly schedule showed similar response rates but     had different toxicity profiles. The most frequent grade 3 or 4 toxicities were neutropenia     in the 3 weekly schedule and fatigue or asthenia in the weekly schedule.      Second, docetaxel and cisplatin have different action and mechanism. Docetaxel showed     characteristic early bone marrow suppression 5-7 days after infusion compared with usual 14     days after infusion of cisplatin. Thus, nadir period is not overlapped when the investigators     administered both drugs concomittantly.      Third, there are many feasible reports of biweekly administration of docetaxel in patients     with NSCLC, breast cancer, stomach cancer, and ovarian cancer with better safety profiles.      Therefore,the investigators designed this phase II study to evaluate the efficacy and     toxicity of biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC     and test the hypothesis that biweekly schedule of docetaxel and cisplatin is better tolerated     than both standard 3 week and weekly schedule in terms of hematologic (neutropenia) and     non-hematologic toxicities (asthenia, interstitial pneumonitis. Additionally the     investigators will evaluate polymorphism associated with this study.   "
239633|NCT00995904|"     This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at     three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable     asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation     aerosol delivery.   "
239627|NCT00995826|"     The purpose of this study is to test the safety and tolerability of an investigational     multi-dose inhaled flu medication, CS-8958. Study participants will include 16 males and     females, aged 18-55 years of age, inclusive. Participants will be divided into two treatment     groups (Groups A and B) with each group consisting of 8 subjects. Participants will be     involved in study related procedures for a maximum of 14 weeks from initial screen to the     follow up visit. 6 subjects in Group A will be administered 40 mg of CS-8958 drug and two     subjects will receive placebo (substance containing no medication), once a week for six     weeks. In Group B six subjects will be administered 40 mg of CS-8958 drug and two subjects     will receive placebo, twice a week for six weeks. Study procedures will include blood and     urine samples, ECGs (measure of heart activity), blood pressure, pulse rate and functional     oxygen saturation of arterial hemoglobin. Also continuous cardiac telemetry will be performed     as well as physical examinations and spirometry assessments.   "
239628|NCT00995839|"     The present study was conducted as a prospective, randomized study to investigate the effects     of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and     microcirculation in patients with catecholamine-dependent septic shock.   "
239629|NCT00995852|"     Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from     unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.   "
239630|NCT00995865|"     The Phase 1 trial is a single-center, randomized, double blind, placebo-controlled,     dose-ranging out-patient study designed to provide the first clinical data on the safety,     tolerability and immunogenicity of XRX-001 inactivated yellow fever vaccine in 60 healthy     male and female volunteers, 18-49 years of age. Subjects will receive two inoculations of one     of two dose levels of XRX-001 vaccine. A control group will receive placebo.      Safety will be determined by the incidence and severity of adverse events in each treatment     group and in the combined cohorts in the double blind treatment period up to 42 days     post-vaccination. Subjects will also be followed-up at 3, 6 and 12 months to determine severe     adverse events (SAEs) and changes in health status.      Efficacy will be assessed by neutralizing antibody response to the vaccine. The co-primary     immunogenicity endpoints will be the dose-response analysis of seroconversion rates (fourfold     or greater increase in neutralizing antibody titer between baseline and Day 42) and of the     50% plaque reduction neutralization test (PRNT50) geometric mean titers (GMT) at Day 42.      Secondary immunogenicity endpoints will include:        1. The seroconversion rates and GMT neutralizing antibody titers for all dose groups          combined on Days 21 and 42.        2. The reverse cumulative distribution curve of antibody titers on Days 21 and 42 for each          dose group and for all dose groups combined        3. The duration of antibody titers displaying the seroconversion rate and GMT across all          time-points to Month 12, by treatment group and for both dose groups combined.   "
239631|NCT00995878|"     The primary goal of this study is to compare the safety and effectiveness of two standard     fibroid treatments: MRI guided ultrasound surgery (MRgFUS) and uterine artery embolization     (UAE). Both treatments are approved by the Food and Drug Administration (FDA) for women who     do not plan to become pregnant.      A second goal of this study is to better understand which symptoms bother women with fibroids     the most. Understanding and addressing the symptoms of clinically-significant uterine     fibroids is important in order to optimize treatment outcomes and control health care costs.      Women who are eligible to participate in the study, are randomized to one of two treatment     arms (UAE or MRgFUS). Women in both arms will receive treatment but will not be able to     choose which treatment she will receive.      A comprehensive assessment of symptoms-including experienced pain- will take place at     baseline, 6 weeks, and at 6, 12, 24, and 36 months following treatment with UAE and MRgFUS.   "
239632|NCT00995891|"     Background:      - Laboratory research studies require control samples from healthy volunteers to compare with     samples from patients. These studies will help researchers better understand and refine     treatments for immune system and inflammatory diseases.      Objective:      - To obtain blood, urine, buccal (mouth) mucosa, normal tissue and bone marrow samples and/or     leukopheresis cells from healthy volunteers.      Eligibility:      - Healthy individuals at least 8 years of age.      Design:        -  Volunteers will be recruited through the Program for Healthy Volunteers, Patient          Recruitment and Public Liaison Office, or self-referral through the clinicaltrials.gov          Web site.        -  Health will be confirmed by a brief history and physical examination and blood work.        -  Volunteers 8 years of age and older will provide blood and urine samples using standard          procedures. Buccal mucosa samples will be obtained by scraping the insides of both          cheeks with a sterile nylon brush.        -  Bone marrow samples will be obtained from volunteers 18 years of age and older by taking          two aspirates from the posterior iliac crest (an area near the hip).        -  Normal tissue samples will be obtained from volunteers 18 years of age and older by          taking superficial skin samples (punch biopsies)        -  Leukopheresis or lymphapheresis will be performed on volunteers 18 years of age and          older to obtain white blood cells for research        -  Samples will be assigned a unique code and will be stored until they are no longer of          scientific value or the volunteer withdraws consent for their use.   "
239634|NCT00995917|"     Many women, particularly adolescent women, suffer from painful menstrual cramps, medically     referred to as dysmenorrhea. Common treatments for menstrual cramps are non-steroidal     anti-inflammatory drugs and oral contraceptives, but both have side effects that limit their     use. Injection of vitamin K into an acupuncture point has been used as treatment for     dysmenorrhea at the Obstetrics & Gynecology Hospital in Shanghai, China since at least 1985.     More research is needed on the effectiveness of this treatment and its acceptability to     different women. The objective of this study is to examine the feasibility and effectiveness     of acupoint injection of vitamin K1 for the treatment of severe primary dysmenorrhea in the     United States. Twenty participants will be randomized to receive either 1) vitamin K1     injection into an acupuncture point at the start of their menstrual cycle followed by a     saline injection in a non-acupuncture point two months later or 2) saline injection in a     non-acupuncture point followed by vitamin K1 injection into an acupuncture point two months     later. The primary outcome measure will be change in pain intensity measured before and after     each treatment. Data on other menstrual symptoms will be collected by telephone or a     web-based survey. Three additional participants will be recruited to receive vitamin K1     injection into an acupuncture point and have blood samples drawn before and after injection     to determine absorption of vitamin K1. The aims of the study are to collect preliminary data     on the efficacy and safety of vitamin K1 injected in an acupoint for the treatment of severe     primary dysmenorrhea; assess the feasibility and acceptability of the treatment among U.S.     women; and test the blood absorption of vitamin K1 following acupoint injection treatment.      The investigators hypothesize that:        1. Vitamin K1 acupoint injection is a safe treatment for women with menstrual pain.        2. Vitamin K1 acupoint injection reduces menstrual pain more than placebo saline injection          does.        3. The treatment of vitamin K1 acupoint injection is acceptable to U.S. women.        4. Vitamin K1 is absorbed into the blood thru acupoint injection.   "
239635|NCT00995930|"     This study will evaluate the effect of ACZ885 on vascular function in patients with     documented atherosclerotic disease and T2DM or IGT.   "
239636|NCT00995956|"     In this study we aim to investigate to what extent the serum albumin concentration in liver     transplant patients treated with mycophenolic acid (MPA) affect the free fraction of MPA.     Furthermore we will investigate if a change in free fraction has implications for the     immunosuppressive effect of MPA by measuring the IMPDH activity. This might in the future     provide opportunity for further individualisation of the treatment with MPA. We will also     investigate if the stabilizers present in pharmaceutical-grade albumin have a displacement     effect on MPA in Vitro (ref).   "
239637|NCT00995969|"     This study will look at how safe and effective, a novel agent, CT 327 cream is in treating     patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily     for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed     throughout the treatment period.   "
239638|NCT00995982|"     Background:        -  Vaccines are substances used to try to create resistance or immunity to a disease and to          prevent an infection. Investigators are looking into improved ways to give and test the          results of different kinds of vaccines.        -  Researchers are interested in comparing the results of an experimental DNA vaccine for          the prevention of seasonal influenza against a standard FDA-approved vaccine for the          prevention of seasonal influenza. The experimental DNA vaccine is not yet approved by          the FDA for preventing the flu.      Objectives:      - To test the safety and immune response of an experimental DNA vaccine for seasonal     influenza, compared to the standard vaccine for seasonal influenza.      Eligibility:      - Healthy individuals between ages 45 and 70 who have not yet received the seasonal influenza     vaccine.      Design:        -  Participants will have six planned clinic visits (Weeks 0, 1, 3, 4, 6, and 27) and two          telephone follow-up contacts (within 2 days after each injection) during this study.        -  Participants will be divided into two groups: one group will receive two standard (TIV)          flu vaccine injections given using a needle and syringe, while the other will receive          the DNA flu vaccine using a needleless injection system followed by the TIV vaccine.        -  The vaccine injections for both groups will be given approximately 3 weeks apart,        -  Clinic staff will observe participants for at least 30 minutes after each vaccination.          One to two days after each injection, participants must telephone the clinic staff, and          for 7 days after the vaccination participants will keep a diary card to report on          possible side effects.        -  During study visits, blood samples will be collected for research purposes to test for          responses to vaccine.   "
239639|NCT00995995|"     Carry out the cost-effectiveness analysis of rosiglitazone on a population in line with the     rosiglitazone license and using UK costs   "
239640|NCT00996008|"     This study will look at how safe and effective, a novel agent, CT 327 cream is in treating     patients with mild to moderate atopic dermatitis (AD). Patients will be treated twice daily     for 14 days on specific lesions of AD and safety and symptoms of AD will be assessed     throughout the treatment period.   "
239641|NCT00996021|"     This will be a randomized, partial-blind, placebo-controlled, single dose, cross-over trial     investigating the effect of GSK1349572 on cardiac repolarization as compared to placebo in     healthy adult males and females. Approximately 42 subjects will be enrolled in this study and     will be admitted to the clinic for three separate dosing sessions. Subjects will receive     single dose administrations of placebo, a supratherapeutic dose of GSK1349572 (250 mg), and     moxifloxacin (400 mg) in random sequence. Safety of subjects will be monitored by clinical     observation, measures of vital signs, 12-lead ECGs and clinical laboratory measurements.   "
239642|NCT00996034|"     This is a molecular imaging research study designed to examine how much nicotine gets into     the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi     Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine     designed as an aid to smoking cessation and long-term abstinence, as well as an aid to     prevent relapses of a treated smoker.      In this project we want to understand the degree to which NicVAX administration changes how     much nicotine enters the brain in smokers.   "
239643|NCT00996047|"     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients will respond to     treatment.      PURPOSE: This research study is looking at bone marrow and blood samples from patients with     leukemia or other hematopoietic cancers.   "
239644|NCT00996060|"     1. Primary Objective:           The primary endpoint to this study will be to document the toxicities, and reversibility          of toxicities, of this regimen of hydralazine and valproic acid in patients with          advanced, unresectable, previously treated lung cancers, for whom no acceptable standard          therapy is available. A primary endpoint will be to determine any potential dose          limiting toxicities, and the Maximal Tolerated Dose of this regimen.        2. Secondary Objectives:      The secondary endpoint of this study will be to determine any potential anti-tumor effects,     as determined by the objective tumor response (complete and partial responses), clinical     benefit (complete and partial responses, and clinical benefit), the time to tumor response,     the time to tumor progression, and the overall survival.   "
239645|NCT00996073|"     The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in     subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral     levels between L1 and S1. All subjects in this study will undergo interbody fusion via     Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF)     procedures with Food and Drug Administration (FDA) approved/cleared supplemental posterior     instrumentation.   "
239646|NCT00996086|"     This is an observational study to learn which patients benefit from CRT therapy and to track     the clinical changes that help identify the risk-level of CRT patients.   "
239647|NCT00996099|"     The purpose of this study is to evaluate the safety and efficacy of a system combining     continuous glucose measurement with a computer-based algorithm for insulin delivery in     patients undergoing elective cardiac surgery.   "
239648|NCT00996112|"     The goal of this study is to further the investigators' understanding of community acquired     methicillin-resistant Staph Aureus (CA-MRSA) and treatment of it by developing real-world     sustainable strategies consistent with existing guidelines on treatment of CA-MRSA from the     Centers for Disease Control and Prevention (CDC) and test these strategies in busy primary     care settings.   "
239649|NCT00996125|"     This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline     Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects     aged 9 - 17 years. One group of subjects will receive the HPV vaccine and the other group     will receive the control.   "
239650|NCT00996138|"     This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule     (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults     based on EMEA/CHMP criteria, and safety & tolerability.   "
239651|NCT00996151|"     The study will evaluate the amount of Testosteron MD-Lotion 2% remaining on the axilla after     a single dose application in healthy males who undergo a post dose washing procedure.   "
239652|NCT00996164|"     The object of this trial is to assess the safety and efficacy of a 24 week course of     flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.   "
239653|NCT00996177|"     The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled     system to deliver fentanyl compared with a patient-controlled intravenous system to deliver     morphine in the management of postoperative pain.   "
239654|NCT00996190|"     During Cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. Low     blood pressure is the most common side effect of the spinal medication used to anesthetize     the patient prior to the start of surgery. This low blood pressure can also trigger     unpleasant side effects such as nausea, vomiting and low Apgar scores for the baby.      Currently there are 2 methods of phenylephrine administration during Cesarean section. One     method is by intermittent bolus and the other is by continuous infusion. It is ideal to have     a regimen for phenylephrine administration that maintains blood pressure without compromising     cardiac output.      In this study, cardiac output and blood pressure will be measured by transthoracic     bioimpedance, which is a new technique of noninvasive continuous cardiac output monitoring.      The hypothesis of this study is that the continuous infusion of phenylephrine will be equally     effective in maintaining blood pressure as compared to the intermittent injection, and will     induce less hemodynamic changes.   "
239655|NCT00996203|"     This open-label single arm study will evaluate the efficacy and safety of tocilizumab added     to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to     severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will     receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition     to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is     24 weeks, and the target sample size is 200.   "
239656|NCT00996216|"     The purpose of this study is to test the safety and tolerability of eltrombopag when used to     increase and maintain platelet count. Platelet count to be maintained at a level sufficient     to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions,     and to avoid permanent discontinuation of antiviral therapy.   "
239657|NCT00996229|"     The researchers will investigate whether caloric restriction or dietary supplementation could     provide positive effects on general brain functions in healthy elderly people.   "
239658|NCT00996242|"     The objective of the present study was to investigate the possibility of using L-lysine, an     amino acid that occurs naturally in food and which interferes with nitric oxide (NO)     production, for the treatment of schizophrenia. L-lysine, 6 g/day, was administered to ten     patients with schizophrenia as an add-on treatment to conventional antipsychotic treatment.     The study was designed as a single-blinded, cross-over study where patients were randomly     assigned to initial treatment with either L-lysine or placebo and screened at baseline, after     four weeks when treatment was crossed over, and after eight weeks when treatment was     terminated. The four-week L-lysine treatment regimen caused a significant increased in blood     concentration of the amino acid and was tolerated well. The analysis of outcome measures     showed a significant decrease in symptom severity as measured by the Positive and Negative     Syndrome Scale (PANSS). Furthermore, the patient's ability to solve the Wisconsin Card     Sorting Task (WCST) was significantly improved indicating increased problem solving capacity     and cognitive flexibility. Subjective reports from three of the patients also indicated     decreased symptom severity and enhanced cognitive functioning. In summary, these findings     suggest potential beneficial effects of L-lysine treatment on symptom severity and cognitive     deficits in patients with schizophrenia.   "
239659|NCT00996255|"     The purpose of this open-label, multi center, phase I study, was to determine the safety     profile of PHA-793887 administered by intravenous infusion to patients with     advanced/metastatic solid tumors. This was a dose-finding study to determine the maximum     tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.   "
239673|NCT00996437|"     This study is being conducted to determine if intravitreal injections of ranibizumab decrease     the proportion of eyes in which vitrectomy is performed compared with saline injections in     eyes presenting with vitreous hemorrhage from proliferative diabetic retinopathy.   "
239674|NCT00996450|"     To document pre-diagnosis educational abilities, to document any change in educational     achievements following treatment, to document educational support given within the statement     process and to document the timing of support.   "
239660|NCT00996268|"     Sixteen healthy subjects will be randomized to each of the 3 parallel treatment groups.     Eligible subjects will check in to the clinical unit on Day -2 and have 24-hr pharmacokinetic     collections on Day -1 and on Day 1. Once the pharmacokinetic parameters of the formulations     have been analyzed, doses of GSK2212836 will be selected for further study in Part B.     Subjects from Part A will participate in Part B.      Part B is a single blind, randomized, placebo controlled study that will consist of a 2-week     repeat dose period with 3 dose levels and one dose of the marketed formulation of GSK2212836.     Subjects will check in to the clinical unit on Day -3; will participate in a test meal on Day     -2 and have 24-hr baseline pharmacokinetic profiles on Day -1 and Day 1. Subjects will be     released from the clinic on Day 2, and return for daily dosing on Days 3 through 12. On Day     6, they will also have a brief outpatient visit. Subjects will check into the clinic again on     the evening of Day 12, and on Day 13 they will again have 24-hr pharmacokinetic profiles     collected. Subjects will be released from the clinical research unit on Day 14, following a     test meal, triglyceride sampling and check-out assessments, and will be released from the     study 5-10 days later after completing a follow up visit.   "
239661|NCT00996281|"     The purpose of this study is to compare the safety and tolerability of azilsartan medoxomil     plus chlorthalidone, once daily (QD), versus olmesartan medoxomil-hydrochlorothiazide in     adults with essential hypertension.   "
239662|NCT00996294|"     Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to     gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of     the operations on diabetes control.   "
239663|NCT00996307|"     This study will evaluate the safety and immunogenicity of different combinations of A/H1N1     2009 (swine flu) vaccine in healthy young children   "
239664|NCT00996320|"     The purpose of this study is to determine whether reducing intern work hours and eliminating     extended shifts in the intensive care unit will reduce prescribing errors and improve intern     well-being.   "
239665|NCT00996333|"     This study is designed to determine whether an investigational drug combination consisting of     Gemzar®, Taxotere®, and Xeloda®, (called GTX) is safe and effective in treating advanced     pancreatic cancer and to study and enhance the utility of PET scans in the evaluation of     patients with pancreatic cancer.   "
239666|NCT00996346|"     Refractory soft tissue sarcoma remains a difficult malignancy to treat. The mammalian target     of rapamycin (mTOR) is an enzyme that plays an important role in cancer cell survival. mTOR     inhibitors, like temsirolimus, have shown activity in sarcoma. Irinotecan is a chemotherapy     drug that has also been used to treat sarcoma. However, it is unknown whether combining these     two drugs would result in improved efficacy with acceptable toxicity.      Therefore, the goal of this phase I study is to determine the maximum tolerated dose (MTD)     and toxicity profile of combination temsirolimus and irinotecan both administered     intravenously on a weekly basis to refractory soft tissue sarcoma patients.   "
239667|NCT00996359|"     RATIONALE: Giving low-dose total-body irradiation before a donor stem cell transplant helps     stop the growth of cancer cells. It also stops the patient's immune system from rejecting the     donor's stem cells. The donated stem cells may replace the patient's immune cells and help     destroy any remaining cancer cells (graft-versus-tumor effect).      PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant after     total-body irradiation and to see how well it works in treating patients with relapsed or     refractory hematologic cancer or acute myeloid leukemia or acute lymphocytic leukemia in     complete remission.   "
239668|NCT00996372|"     The objective of this trial is to assess the safety and efficacy of 24-week course of     flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally     postmenopausal women.   "
239669|NCT00996385|"     Study chemotherapy will consist of four treatments with Velcade (days 1, 4, 15, and 18) and     two treatments with Eloxatin(days 4 and 18). Patients will be undergo standard of care blood     work and Quality of Life (QOL) questionnaires at each visit and will be have repeat CT scans     performed to assess tumor response every 2 cycles (8 weeks). Each patient will be allowed to     receive a maximum of 6 cycles of therapy. Following discontinuation of treatment due to     disease progression or completion of therapy, patient's will be followed for survival, QOL     assessments, and tumor assessments every 3 months (or as clinically indicated) for the first     year and every 3 months thereafter for a maximum of 5 years.   "
239670|NCT00996398|"     The aim of this project is to assess the effect of cold water immersion on knee joint     re-positional sense in healthy subjects. Cryotherapy, in the form of cold water immersion,     had previously been shown to improve athletic performance however, debate exists within the     existing literature regarding whether proprioception, in the form or joint position sense, is     effected post treatment.      Null hypothesis (H0): Water immersion has no effect on joint position sense (JPS).      Alternate hypothesis (H1): Water immersion has an effect on joint position sense.   "
239671|NCT00996411|"     This study is characterizing the subject-rated and behavioral effects of salvinorin A in     healthy volunteers. The investigators hypothesize the salvinorin A will have     hallucinogen-like effects.   "
239672|NCT00996424|"     Inhalation treatment with mucolytics is one of the cornerstones of CF treatment for     respiratory problems.      The efficacy of inhalation treatment with recombinant DNAse and hypertonic saline is well     established. The North American CF foundation reported that there is insufficient evidence     for or against the chronic use of inhaled N-Acetylcysteine (NAC) to improve lung function and     reduce exacerbations .      In vitro tests proved the positive effect of NAC on sputum rheology . Evidence based research     however on the in vivo effect of NAC on visco-elasticity and lung function is rare. There are     only three randomized controlled clinical trials on nebulised NAC, none of them showing a     statistically significant or clinically relevant beneficial effect. Nevertheless at least in     Europe for many years inhalation treatment with NAC is advised. Because of the disgusting     sulphur odour, many patients are reluctant to use this inhalation medication.      We intend to start an open placebo controlled in vivo cross-over study to evaluate the effect     of Acetyl cysteine compared to normal saline on the sputum visco-elasticity and on the short     term effect on lung function.      Sputum producing CF-patients, able to perform lung function tests will be enrolled.      Sputum viscoelasticity will be measured by a controlled-stress rheometer (AR 1000-N;     TA-Instruments, Ghent, Belgium) at 20° C, using a cone-plate geometry 8.      Lung function measurement (FVC, FEV1, FEF 25-75) will be done in a Masterlab body     plethysmograph (Jaeger®) Sputum samples will be collected before lung function test on a     regular control visit. Three ml of NAC or 4 ml of normal saline will be inhaled, afterwards a     second sputum sample will be collected and a control lung function test will be performed.     Visco-elasticity measurements will be done on sputum samples before and after inhalation of     NAC or normal saline. Patients will continue to inhale N-acetylcysteine or normal saline two     times per day for one month. After one month a control lung function and a third sputum     sample will be collected, visco-elasticity and lung function will be measured and compared to     the initial values in both groups and between groups. After a wash-out period of normal     saline inhalations during 2 weeks in both groups, patients in the initial control group will     be asked to switch to inhalation of 3 ml of NAC two times per day and the former NAC group     will continue to inhale two times 4 ml of normal saline during four weeks. After one month     the same measurements of visco-elasticity and lung function tests will be done.   "
239675|NCT00996463|"     The rationales of a clinical trial comparing intralesional antimonial therapy versus wound     care management in patients with old world cutaneous leishmaniasis (OWCL) are the following:        1. The effectiveness of the current mainstay treatment with intralesional antimonials for          CL is subject to discussion, especially in L. major lesions which are predominant in          Northern Afghanistan        2. The importance of wound care management in patients with OWCL has been emphasized by          Gonzalez et al. (2008) and its efficacy is confirmed in the Kabul trial with L. tropica          patients.      Parallel to the clinical efficacy the trial investigates the cost-effectiveness and -utility     of the treatment options under study.   "
239676|NCT00996476|"     The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores     what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a     and Ribavirin in genotype 1 hepatitis C virus infected Japanese participants who have never     received treatment for their hepatitis C infection.   "
239677|NCT00996489|"     This is a post approval study of Coaptite® in the treatment of female urinary incontinence.   "
239678|NCT00996502|"     The primary objectives of this study are to evaluate the safety and best dose of a regimen     including bevacizumab and erlotinib in combination with docetaxel and prednisone. In     addition, the investigators wish to evaluate how well these drugs might work against this     disease. Bevacizumab and erlotinib are novel drugs that attack the blood vessels supplying     the tumor cells and attack a receptor on the tumor cells, respectively. This study has two     parts. In the first part of the study, eighteen patients will be enrolled. Patients will     receive escalating doses of docetaxel in combination with standard doses of bevacizumab and     erlotinib until the safest dose is determined. An additional 37 patients will enter into the     second part of the study and all will receive the safest dose. In this part of the study, the     effectiveness of this regimen against hormone refractory prostate cancer (HRPC) will be     monitored by evaluating prostate-specific antigen (PSA) and objective response of the tumor.   "
239679|NCT00996515|"     PRIMARY OBJECTIVES:      I. To document the toxicities, and reversibility of toxicities, of this regimen of     5-azacytidine (azacitidine) and erlotinib (erlotinib hydrochloride).      SECONDARY OBJECTIVES:      I. To determine any potential anti-tumor effects, as determined by the objective tumor     response (complete and partial responses), clinical benefit (complete and partial responses,     and clinical benefit), the time to tumor response, the time to tumor progression, and the     overall survival.   "
239680|NCT00996528|"     The purpose of this study is to test a mother-to-mother intervention during pregnancy and     after delivery with mothers in South Africa, most of whom are at risk delivering babies with     fetal alcohol syndrome, babies that are underweight, or babies that are infected with HIV     from an HIV-positive mother. The investigators hypothesize that the intervention will reduce     the chance of these three health outcomes occurring in the babies and improve the health of     the mother.   "
239681|NCT00996541|"     Runaway and homeless youth are at risk for HIV based upon their rates of substance use,     particularly injection drug use, unprotected sexual intercourse, multiple partners, and     sexually transmitted diseases. Risk increases as the time away from home increases. STRIVE is     a family intervention aimed at increasing residential stability, decreasing runaway episodes,     and decreasing HIV risk. Families are randomly assigned to a cognitive-behavioral     skills-building intervention consisting of five weekly sessions delivered at family homes, or     are assigned to standard care. Sessions are aimed at increasing problem solving, role     clarity, and positive interactions. It is hypothesized that the intervention will result in     improved family dynamics, less runaway behavior, and less risky behavior.   "
239682|NCT00985686|"     The purpose of this project is to explore the potential value and practicality of an     innovative depression intervention for young people. More specifically, the objectives of     this project are:        1. to pilot the Internet-based Spirituality Program with depressed young people (age 13-24)          in Calgary by:             1. obtaining preliminary estimates on the impact of the program on the primary outcome               of depression severity, and secondary outcomes of spiritual well-being and               self-concept.             2. obtaining preliminary estimates on response rates and remission rates to guide               sample size estimations for a full size randomized trial.             3. evaluating if the suggested research methodology is feasible with respect to               recruitment rate, patient burden and clinical implementation to guide design of a               full size randomized trial.        2. to gather feedback from depressed young people, their families and referral sources in          the community (schools, family physicians, mental health outpatient services) on the          perceived value of the program and on ways to eventually make it available as a          community resource for others dealing with depression.   "
239683|NCT00985699|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is looking at genes in tissue samples from patients with B-cell     non-Hodgkin lymphoma.   "
239684|NCT00985712|"     The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory     function, when used over 24 weeks for prandial insulin injections achieves superior glycemic     control, when compared to the conventional HumaPen Luxura without memory function.   "
239685|NCT00985725|"     To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI)     when used as an adjunct to stable, standard therapy in the setting of partial or full     remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive     Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult     Version (BRIEF-A).   "
239686|NCT00985738|"     The purpose of this study is to determine the effect of short-term intake of daily     Dutasteride in patients with prostate cancer.   "
239687|NCT00985751|"     This study will assess the safety, reactogenicity and immunogenicity of different     formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in     combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a     2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23     months at the time of first vaccination. Considering that febrile reactions are frequently     observed following pneumococcal vaccination, usually co-administered with other routine     paediatric vaccines, the primary study objective will focus on evaluating the increase in     grade 3 fever (i.e. rectal temperature >40.0°C).   "
239702|NCT00985946|"     This summary will use Panobinostat (LBH589) in patients with neuroendocrine tumors to see how     the patient's tumor responds to panobinostat. Additionally, this study will examine how long     it takes neuroendocrine tumor patient's cancer to progress while taking the drug and examine     the overall survival of patients using panobinostat. Also, the study will examine the     toxicity and tolerability of panobinostat in the patient population. Finally, this study will     look at the effect of panobinostat on Notch 1 signaling before and after treatment with     panobinostat.   "
239703|NCT00985959|"     The purpose of the study in Phase I is to select the recommended dose of bortezomib in     combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess     the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I     portion).   "
239755|NCT00997607|"     This study will test two new vaccines, one for Ebola and one for Marburg virus, to see if     they are safe, if they have side effects, and if they create an immune response in people who     receive them.   "
239691|NCT00985803|"     The purpose of this study is to check the improvement in quality of life in patients with     systemic lupus incorporated into a routine of physical activity.      Randomized controlled blinded trial, 63 patients aged 42.9 ± 14.4 and diagnosis of systemic     lupus erythematosus (SLE) according to the criteria of the College American Rheumatology,     1997. After randomization patients were allocated into 3 groups, control group (CG) (n = 21),     training cardiovascular (CT) (n = 20), resistance training (RT) (n = 22), performing 12 weeks     of intervention with a frequency of three times weeks and were evaluated at two different     times (T0 and T12). As primary outcome quality of life was assessed by the inventory Generic     Assessment of quality of life by the Medical Outcomes Study 36 -- Healthy ItemShort Form     Survey (SF36) and as secondary outcomes functional capacity evaluation of pain symptoms     (visual scale analogue pain [VAS]), intensity of symptoms of depression (Beck Depression     Inventory [BDI]), index of disease activity (Systemic Lupus Disease Activity Inventory     Erythmatodud [SLEDAI]), capacity aerobic (walking test of 12 minutes [T12]), subjective     perception effort (subjective scale of Borg [Borg]), limb muscle strength lower (analog     dynamometer [strength]), electrical activity member lower (surface electromyography [EMG]),     amount of products (inventory amount of Medicines).   "
239692|NCT00985816|"     The investigators propose a Phase II interventional trial to investigate the role of     Lactobacillus reuteri DSM 17938 on the intestinal motility and immune response of premature     infants and further evaluate safety of the use of this probiotic in a population of premature     infants.   "
239693|NCT00985829|"     The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors     that affect response rate.   "
239694|NCT00985842|"     Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance     phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual     limb and occlude blood flow. This occlusion can be relieved during swing phase, but may     depend on type of prosthesis. The purpose of the proposed research is to: (1) discover the     range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees     during gait and (2) to learn which of five different prosthetic limb systems provides greater     tissue oxygenation.   "
239695|NCT00985855|"     Phase II, randomised, controlled, non comparative study with 2 parallel groups:        -  Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed          by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine          associated with a weekly cetuximab infusion during the radiotherapy.        -  Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed          by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide          associated with a weekly cetuximab infusion during the radiotherapy.   "
239696|NCT00985868|"     RATIONALE: AT9283 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of AT9283 in children     and adolescents with relapsed and refractory solid tumors.   "
239697|NCT00985881|"     The purpose of this study is to determine if subthreshold vibration, when applied to the     residual limb of a lower limb amputee through their prosthetic socket, can sufficiently     enhance peripheral sensation to result in an improved ability to balance and walk.   "
239698|NCT00985894|"     The purpose of this study is to determine if an asynchronous online model of teledermatology     can achieve similar clinical outcomes as compared to conventional in-office care for the     management of atopic dermatitis. The investigators also aim to determine the effects of this     online care model on patient quality of life as well as patient and physician satisfaction.      The investigators' hypotheses include the following:        1. Compared to in-person visits, the online care model will result in similar clinical          improvement in atopic dermatitis disease severity.        2. Compared to in-person visits, the online care model will result in similar improvements          in quality of life.        3. Providers and subjects in the online group will achieve a similar level of overall          satisfaction as those in the in-person group.   "
239699|NCT00985907|"     The median overall survival (OS) of relapsed/refractory multiple myeloma (MM) is less than     nine months. However, phase II data with the proteasome inhibitor bortezomib (Velcade®) has     been heartening, with 35% overall response rates and median survival of 16 months. In-vitro     data has shown that this agent dramatically increases the sensitivity to chemotherapeutic     agents. Liposomal doxorubicin (Doxil), melphalan, and bortezomib all have different     mechanisms of action and toxicity profiles. Clinical studies employing two drug combinations     with these agents in patients with refractory MM have found favorable efficacy (nearly no     progression of disease) and tolerance data. Thus, the investigators are initiating a phase     I/II study to examine the safety and efficacy of combining all three agents into the regimen     DMV (Doxil® + melphalan + Velcade).   "
239700|NCT00985920|"     Total knee arthroplasty (TKA), the definitive treatment of osteoarthritis, is often     associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the     objective of the proposed study is to determine the role of topical application of tranexamic     acid (TA), an anti-fibrinolytic agent, into the knee joint just before closure during TKA to     reduce perioperative bleeding. The investigators' hypothesis is that in patients undergoing     unilateral primary TKA, intraoperative application of 1.5 g or 3.0g topical TA into the knee     joint before closure reduces perioperative bleeding as depicted by a decrement in the maximal     drop in hemoglobin concentration following surgery. This proposal describes a randomized,     double-blinded, placebo-controlled clinical trial with three arms. The primary outcome is the     extent of the postoperative reduction in hemoglobin levels. Secondary outcomes will include     transfusion requirements, hospital stay, joint functionality, quality of life and safety of     using topical TA. Topical application of TA is a novel intraoperative approach that has not     been used or studied in TKA. However if it is effective, it will directly reduce     postoperative intra-articular bleeding without subsequent systemic absorption and     thromboembolism. In addition, the reduction in microvascular intra-articular bleeding will     lead to less pain and infection rates as well as improved surgical functional outcomes.   "
239701|NCT00985933|"     The purpose of this study is to assess if ketamine will induce, in healthy volunteers,     impairment of working memory and if the drug AZD8529 will block the effects of ketamine on     working memory as assessed by functional magnetic resonance imaging (fMRI).   "
239704|NCT00985972|"     The aim of this study focuses on obtaining accurate information on the effectiveness of     interventions involving physical activity and/or nutrition education developed in the school     environment. This study is intended to assist in future assembly and development of effective     school practices related to preventing and reducing levels of overweight in children and     adolescents.      Updated data from the systematic review:      5,899 studies were retrieved in 14 databases (Assia, Central Cochrane, CINAHL, EMBASE, ERIC,     ISI, LILACS, Physical Education Index, PsycINFO, PubMed, Social Care Online, Social Services     Abstracts, Sociological Abstracts, SPORTDiscus)      1,228 were excluded as duplicates by Eppi Reviewer      4,678 studies referred for evaluation by title and abstracts (4,671 by systematic searches, 7     by cross-references list)      211 full text papers reviewed by EPHPP and GRADE tools      140 studies with data extracted      Body Mass Index Results:        1. Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. The effect of school-based physical          activity interventions on body mass index: a meta-analysis of randomized trials. Clinics          (Sao Paulo). 2013 Sep;68(9):1263-1273 - Isolated Physical Activity interventions: 0.02          (95%CI: -0.13, 0.17; 11 trials; n=4,273; I2=77%)        2. Silveira JA, Taddei JA, Guerra PH, Nobre MR. The effect of participation in school-based          nutrition education interventions on body mass index: a meta-analysis of randomized          controlled community trials. Prev Med. 2013 Mar;56(3-4):237-43 - Isolated Nutrition          Education interventions: -0.33 (95%CI: -0.55, -0.11; 8 trials; n=8,491; I2=95%)        3. Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. School-based physical activity and          nutritional education interventions on body mass index: a meta-analysis of randomized          community trials - Project PANE (manuscript under review) - Combined Physical Activity          and Nutrition Education interventions: -0.03 (-0.09, 0.04; 38 trials; n=28,870; I2=83%)          / All interventions included: -0.03 (95%CI: -0.09, 0.03; 55 trials n=41,634; I2=87%)   "
239705|NCT00985985|"     A multi-center, randomized, double-blind, placebo-controlled, 4-arm clinical study to     evaluate efficacy and safety of nicotine lozenge (2mg and 4mg) in smoking cessation in adult     cigarette smokers who are motivated to quit smoking. Successful quitters or participants who     smoke occasionally will be followed up after week 24 till 12 months.   "
239706|NCT00985998|"     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located     in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical     efficacy has been shown in adult with head and neck cancer. The study assessed the safety,     and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy     in patients with advanced non-small cell lung cancer (NSCLC).   "
239707|NCT00986011|"     RATIONALE: Overweight and obesity have been associated with multiple types of disease,     including cancer. Living in a smart growth community may encourage behaviors that would     reduce the risk of obesity.      PURPOSE: This research study is looking at the effect of a smart growth community on     prevention of obesity in middle-, moderately low- and low-income families.   "
239708|NCT00986024|"     The aim of the present study was to evaluate the effects of aerobic interval training versus     strength training or a combination of these regimes on factors comprising the metabolic     syndrome in order to find the most effective exercise regime for patients with metabolic     syndrome.   "
239709|NCT00986037|"     The primary purpose of this study is to determine the safety, tolerability and     pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate     controlled asthma.   "
239710|NCT00986050|"     The DEBATER study is designed to determine the superiority of abciximab over no abciximab and     to determine the superiority of drug eluting stents over bare metal stents in patients with     acute myocardial infarction who undergo percutaneous coronary intervention.   "
239711|NCT00986063|"     Genetic tests has been suggested to reduce side effects related to Nevirapine(NVP), a     commonly prescribed component of highly active antiretroviral therapy(HAART) in developing     countries. This clinical trials is designed to determine the efficacy and the     cost-effectiveness of this approach in the developing countries setting.      NVP-based HAART and efavirenz(EFV)-based HAART will be provided through Thai national     universal health coverage. Information of the prescribed drug will be collected, and     monitoring for the compliance with the prescribed highly active antiretroviral therapy will     be conducted.      Outcome measurements:      The primary objective of this study is to evaluate the reduction in incidences of NVP     associated cutaneous side effects by genotype based personalized prescription. The volunteers     will be monitored for any solicited and non-solicited adverse effects for 6 months after drug     administration, with first 6 weeks intensive monitoring for cutaneous adverse reactions.     Laboratory safety profiles (Complete Blood Count(CBC), Alanine transaminase(ALT), Aspartate     transaminase(AST), Blood Urea Nitrogen(BUN), creatinine, direct bilirubin, total bilirubin,     lactate dehydrogenase, alkaline phosphatase) will be assessed during the intensive monitoring     period (6 weeks).      Statistical Methods:      Descriptive statistics will be used to evaluate the conduct of the study. Analysis variables     will include overall follow-up rate, drug compliance, and events of protocol violation.      Laboratory and safety data will be presented using comparative statistics for each study     group and compared within and between groups using standard parametric or non-parametric     comparison tests, i.e., McNemar's test or paired t-test as appropriate.      Comparison of rate of cutaneous adverse reaction, hepatitis and severe cutaneous adverse     reaction(SCAR) will be made with chi-square test. Variable that shown significant different     between the standard of care or control group and the genetic test or intervention group     will adjusted for the final analysis with Poisson logistic regression.      The overall rate of adverse events in all participants will be monitored whether the rate of     adverse events is lower than the predefined criteria. The extension of trial may be     considered based on the rate of adverse events.   "
239712|NCT00986076|"     The purpose of this study is to determine if intraocular infusion of low-molecular weight     heparin (enoxaparin) influences postoperative inflammation following pediatric cataract     surgery with intraocular lens (IOL) implantation.   "
239713|NCT00986089|"     To evaluate the continuation of the Copper IUD at one year after placement through the     cesarean incision into the uterus at the time of cesarean section.   "
239714|NCT00996554|"     The purpose of this study is to examine the frequency of postoperative complications     depending on the number of suture layers in colo-colonic and ileo-colonic anastomoses     Hypothesis: double-layer suture has less anastomotic leakages compared to single-layer     suture.   "
239737|NCT00996853|"     The focus of this study is to assess the safety of GSK's H1N1 vaccine in real life conditions     as soon as the vaccine is used, in a mass vaccination programme, and with a system for rapid     generation, communication and evaluation of safety data.      This study is a commitment to the European Medicines Agency (EMEA), as part of     GlaxoSmithKline Biologicals' (GSK Biologicals') risk management plan for pandemic influenza     vaccination.   "
239884|NCT00999297|"     A 4 week intake of drug to find a natural substance that may modify energy balance and may     enhance health in combination with lifestyle changes with possible decrease in body weight.   "
239740|NCT00997412|"     This is an randomized, double-blind, double-dummy trial, and the objective is to compare the     efficacy and safety of Mycophenolic acid (MA) and Azathioprine (AZA), immunosuppressive     drugs, in myasthenia gravis patients. This prospective study will enroll 40 myasthenia gravis     (MG) patients who are poor controlled under prior steroid therapy. All subjects should be     randomly assigned to MA group and AZA group that will receive routine pyridostigmine and     prednisolone in combination with MA or AZA.   "
239741|NCT00997425|"     Main hypothesis. Floor and door visual exit barriers will decrease exit-seeking wandering     (exit door approaches) proximal to exit doorways by persons with dementia who wander.   "
239715|NCT00996567|"     Multicenter, open phase 2 study on patients with malignant mesothelioma. Standardly, 4 to 6     cycles of palliative chemotherapy, platinum in combination with pemetrexed, are given.     Despite of this treatment, median survival is poor (9-12 months). By combining conventional     cytotoxic agents with a novel agent, hopefully treatment and survival can be approved.     Cetuximab or Erbitux is a monoclonal antibody against the EGFR (Epidermal Growth Factor     Receptor). By blocking the receptor, it interferes with cel growth and division. Most     mesothelioma show a strong expression of the EGFR protein. Apart from that, Cetuximab also     has antibody-dependent cell-mediated cytotoxicity (ADCC).      In this trial, patients will be treated with standard chemotherapy, combined with Cetuximab     weekly. After a maximum of 6 cycles of chemotherapy, administration of Cetuximab will be     continued until disease progression. Every 6 weeks, a CT scan will be done to evaluate     therapy. Most common side effect of Cetuximab is acneiform rash.      The translation research program consists of the determination of EGFR- and K-Ras mutations     on the tumor tissue and the correlation with outcome.      In the first part of the trial, 18 patients will be included. After a positive interim     analysis, a total of 43 patients will be included.   "
239716|NCT00996580|"     This is an open-label, single-treatment study. All subjects will receive 12 months of oral     contraceptive therapy with DR-103. Study participants will receive physical and gynecological     exams, including Pap smear. During the study, all participants will be required to complete a     diary.   "
239717|NCT00996593|"     This is a single-arm, open-label, multicenter study of Iodine I-131 Anti B1 Antibody     (Tositumomab and Iodine I 131 Tositumomab) for treatment of non-Hodgkin's lymphoma (NHL) who     were previously treated with rituximab antibody. Patients must have been treated with at     least 4 doses of rituximab and have progressed during or following rituximab therapy.      Patients will undergo two dosing phases of study. In the first phase, termed the dosimetric     dose, patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 70     minutes immediately followed by a 30-minute infusion of Anti-B1 Antibody (35 mg) which has     been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained on     Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Using the dosimetric     data from three imaging timepoints, a patient-specific dose of Iodine-131 will be calculated     to deliver the desired total body dose of radiotherapy. In the second phase, termed the     therapeutic dose, patients will receive a 70-minute infusion of unlabeled Anti-B1 Antibody     (450 mg) immediately followed by a 30-minute infusion of 35 mg Anti-B1 Antibody labeled with     a patient-specific dose of Iodine-131 to deliver a whole body dose of 75 cGy to patients with     no hematologic risk factors. Patients who have platelet counts of 100,001-149,999 cells/mm3     will receive 65 cGy and patients who are obese will be dosed based upon 137% of their lean     body mass. Patients will be treated with either saturated solution potassium iodide (SSKI),     Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the first     infusion of the Iodine-131 Anti-B1 Antibody (i.e., dosimetric dose) and continuing for 14     days following the last infusion of Iodine-131 Anti-B1 Antibody (i.e., therapeutic dose).      The endpoints of the study are to determine the response rate, complete response rate,     duration of response, and time to progression or death, based on both a Masked Independent     Randomized Radiographic and Oncologic Review (MIRROR) panel and the Investigators, and the     Investigators' assessment of safety and survival of survival of Iodine-131 Anti-B1 Antibody     therapy in NHL patients who have previously been treated with rituximab.   "
239718|NCT00996606|"     This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in     combination with DMARDs in participants with moderate to severe active rheumatoid arthritis     who have an inadequate response to DMARDs. Participants will receive tocilizumab as 8     milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks in addition to     their current DMARD therapy.   "
239719|NCT00996619|"     Lesions, polyps and other abnormalities in the gastrointestinal (GI) tract have a different     composition compared to the normal mucose. The investigators plan to gather spectroscopic     information from these features. Characterizing their unique spectrums, may help to enhance     the detection and identification of these objects during endoscopy.   "
239720|NCT00996632|"     Background: Lymphatic stasis and seroma formation are common complications of axillary     lymphadenectomy in breast cancer surgery. The investigators aim is to test the hypothesis     that the use of an ultrasonic knife for axillary dissection reduces the total amount and     duration of persistent drainage and length of hospital stay. Method: The investigators have     conducted a randomized trial on 94 patients (1 male, 93 females, mean age 64.7 years) who     presented to the investigators unit with operable breast carcinoma. Patients in group A (38     cases) were operated on using exclusively the ultrasonic knife. Patients in group B (56     cases) were operated on using the conventional diathermy knife.   "
239721|NCT00996645|"     There remains a large gap between ideal and actual care provided to patients with chronic     diseases. Performance feedback reports are often used as a foundation for quality improvement     interventions. There have been hundreds of trials investigating the use of feedback reports;     the important question to ask now is not whether performance feedback reports can help to     improve quality of care, but how to optimize feedback interventions to accomplish that goal.     The purpose of this study is to test whether a theory-based intervention added to feedback     reports sent to primary care providers can result in improved outcomes for patients with     chronic disease.   "
239722|NCT00996658|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to     metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with     insufficient glycaemic control.   "
239723|NCT00996671|"     The purpose of this study is to test the safety of a new drug and to look at how the drug is     handled by your body. This is the first time the drug will be given to people, the drug has     been safely given to animals over many days at higher doses than will be given in the study.     The study will be done in healthy men and woman to determine what effects, good or bad, it     has on thier health. This study will find out:      If the drug has any side effects after one dose of the drug is given? How much of the drug     gets into the bloodstream, and how long does the body take to get rid of it? If the drug     causes any changes to a substance that is in skin, hair or blood.   "
239724|NCT00996684|"     The purpose of this study is to determine whether microplasmin given by intravitreal     injection is effective and safe for the treatment of wet age-related macular degeneration     (AMD) in patients who have focal vitreomacular adhesion (VMA)   "
239738|NCT00996866|"     Vitamin D deficiency is common in obese patients. Most of vitamin D supplementation studies     were done with non-obese subjects. This study looks at vitamin D supplementation requirements     in obese patients as compared to non-obese subjects. This study also looks at changes in     vitamin D level in obese patients undergoing medical weight loss. It is thought that obese     patients have vitamin D deficiency through storage of vitamin D in the fat compartment not     readily available for blood measurement. The investigators' hypothesis is that with medical     weight loss vitamin D levels will increase in obese subjects.   "
239739|NCT00996879|"     The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of     the CYP3A4 Probe Midazolam.   "
239725|NCT00996697|"     Different medications are often used in combination for the condition COPD (chronic     obstructive pulmonary disease). Some medicines act by opening the airways (bronchodilators)     and some act as anti-inflammatories (steroids). More recently an approach of using a     combination inhaler (containing a steroid and a long-acting bronchodilator) at the same time     as a long acting bronchodilator of a different group of medicines (anti-cholinergics     inhalers) has been used. This approach is sometimes called 'triple therapy'. Studies which     have looked at these combinations usually use only standard blowing tests (spirometry) to     test these medicines and focus on the effects of the medicines at their highest (peak)     levels. It is some ways more relevant to study these medicines towards to end of the dose     period (trough)- just before the next dose. This is when there is less medicine in the     system, and differences in drug effects are more obvious. There are also more detailed     breathing tests than spirometry which get a more detailed picture of the way the lungs     respond to bronchodilator medicines. The investigators have studied 'triple therapy' in COPD,     by measuring the effects at the end of the dosing interval (trough) using a range of detailed     respiratory tests.   "
239726|NCT00996710|"     This study will look for new types of gene changes that may be related to cancer in some     patients. Some gene changes (mutations) are passed on from parents to offspring (child).     Other gene changes are new and are seen for the first time in a child. They are not seen in     the parent.      Some of these gene changes may cause cancers in the offspring. We will look for gene changes     by studying patients with cancer their parents and family members without cancer. In this     study, we will be able to find gene changes that occur in the cancer patient but not in the     rest of the family. Knowing the role that new gene changes play in cancer risk may help us     find people at a higher risk of getting cancer.   "
239727|NCT00996723|"     This is a Phase I clinical trial evaluating the combination of vandetanib and dasatinib     during and after radiation therapy (RT) in children with newly diagnosed diffuse intrinsic     pontine glioma (DIPG).   "
239728|NCT00996736|"     The purpose of this study is to determine if natamycin or voriconazole results in better     visual outcomes in fungal corneal ulcers, especially visual acuity.   "
239729|NCT00996749|"     This phase I trial is studying the best way to give omega-3 fatty acids in treating patients     with advanced prostate cancer. Omega-3 fatty acids may slow disease progression and may be an     effective treatment for patients with advanced prostate cancer   "
239730|NCT00996762|"     This study will assess alternative formulations of lapatinib for relative bioavailability and     bioequivalence (BE) with the current commercial formulation (reference). Subjects will be     dosed for at least one week (7 days) on each formulation and PK samples will be collected     after each lapatinib formulation dosing Period on Period 1 Day 7 and Period 2 Day7 at     pre-dose and up to 24 hrs post dose. The study may evaluate up to three alternative test     formulations. After subjects complete the PK evaluation at the End of Study Visit, if they     are eligible, they will have the option to enter EGF111767, an open-label, Phase Ib     continuation study of lapatinib monotherapy or lapatinib in combination with other     anti-cancer treatments.   "
239731|NCT00996775|"     This research study will examine the effectiveness of a brief, computerized motivational     intervention plus treatment-as-usual to treatment-as-usual alone for treating alcohol misuse     in Veterans presenting to primary care. The investigators aim to recruit 162 Veterans     screening positive on the AUDIT-C to participate in this study. Participants will be randomly     assigned to one of the two intervention conditions and be asked to complete a baseline     assessment and two follow-up assessments conducted at three and six months post treatment.     Baseline assessments will be conducted in person by a trained research assistant, while all     follow-up interviews will be conducted over the phone. The primary outcome for this clinical     trial is the reduction in the number of heavy drinking days. Several secondary outcomes will     be collected including health status, depressive symptoms, consequences of drinking, pain     symptoms, and distress tolerance. The findings from this study may have large scale     implications for how alcohol misuse is treated in primary care. In addition, this study will     provide evidence for the feasibility of using the computer as a method for delivering     evidence-based mental health interventions in primary care.   "
239732|NCT00996788|"     To study the anti free radical & inflammatory effect and safety of Rebamipide in patients     suffering of dyspepsia due to chronic gastritis.   "
239733|NCT00996801|"     This study seeks to demonstrate that additional gain in bone mineral density (BMD) can be     achieved by switching to MK-5442 from an oral bisphosphonate in participants who have been     receiving oral bisphosphonate therapy for at least 3 years.   "
239734|NCT00996814|"     The primary aim of the study is to demonstrate the value of a preemptive approach to ethics     consultation in an ICU. The investigators hope to answer the question: Will proactive ethics     interventions by a skilled and experienced ethicist, participating in treatment discussions     with physicians and nurses, as well as discussions with patients/surrogates, improve the     quality of ICU care experienced by patients requiring prolonged treatment in the ICU (5 days     or longer) by increasing their perceived quality of care and reducing the length of stay in     the ICU by non-survivors?      The study is a randomized trial of the use of an ethics consultant to address latent or     manifest ethical issues in patients who remain in the ICU for five days or more, as compared     to usual care. The investigators are testing the hypothesis that expanding the role of ethics     consultations in the ICU to make them proactive will improve the process and outcomes of     patient care by shortening the length of stay in non-survivors, and reducing suffering and     unwanted and/or unnecessary aggressive treatments.   "
239735|NCT00996827|"     This project seeks to understand differences in the serum vitamin D levels and immune status     in cutaneous malignant melanoma patients with different UV exposure histories in New Mexico.   "
239736|NCT00996840|"     This is an early phase (Phase IIa), randomized, double-blind, parallel group, multi-centre     study for subjects with trauma (physical injury) who are at risk for developing Acute Lung     Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). The primary purpose of the study     is to evaluate the safety and tolerability of SB-681323, which is a potent, selective     inhibitor of p38 alpha (MAPK) (prevents inflammation of tissue), in comparison to a placebo.   "
240660|NCT01005485|"     The primary hypothesis of this study is that circulating endothelial cells (CECs) harbor key     genetic and structural characteristics predisposing individuals to acute atherosclerotic     plaque rupture and heart attack.   "
239742|NCT00997438|"     The purpose of this study is to learn about how the antioxidant, lipoic acid, works in the     body and how it may help in the management of relapsing remitting and secondary progressive     multiple sclerosis. This study will compare how subject's and healthy volunteers bodies     absorb and break down the supplement. This information may help in developing new therapies.   "
239743|NCT00997451|"     This study will evaluate, in a primary care setting, the effectiveness of a brief     self-management behavioral treatment in patients with medically unexplained chronic fatigue.     The hypothesis will be tested that fatigue self-management will yield improvements in     fatigue,functioning, and distress in comparison to the two control conditions: standard     medical care alone or standard medical care plus an attention control symptom monitoring     condition.   "
239744|NCT00997464|"     Study of the factors that affect interest in - and uptake of - genetic testing for variants     that predispose to prostate cancer from the perspective of the patient.   "
239745|NCT00997477|"     This study will evaluate the correct use of sequential formoterol and budesonide inhaler     capsule treatment via Aerolizer and patient satisfaction in adult asthmatics.   "
239746|NCT00997490|"     The efficacy and tolerability of Neurapas® balance was compared against placebo in this     single-centre, controlled, double-blind study in patients with a mild depressive episode.      After a one-week placebo run-in phase to exclude placebo responders, patients were given the     study medication (Neurapas® balance or placebo) for 6 weeks in a dose of 3 x 2 tablets daily.      The improvement in symptoms of depression was assessed on the basis of the internationally     established Hamilton Depression Scale 21. The Self-Rating Depression Scale (SDS), the     Hamilton Anxiety Scale (HAM-A), the Clinical Global Impressions (CGI), Quality of Life     questionnaire (SF-36) according to Bullinger (German version) and a Sleep questionnaire (SQ)     were used as further efficacy criteria.   "
239747|NCT00997503|"     The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study     designed to collect real-world safety and clinical outcomes in approximately 4,200 patients     receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual     antiplatelet therapy (DAPT) drug regimen.      This study will also contribute patient data to an FDA-requested and industry-sponsored     research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT     Study).   "
239748|NCT00997516|"     Recent advances in laparoscopic instrumentation have made it possible to perform     intra-abdominal operations entirely through a small incision that can be hidden within the     umbilicus. The goal is to perform surgery with fewer incisions and no visible scars. Other     potential benefits are faster recovery, less pain, and fewer wound complications. The term     SILS (Single Incision Laparoscopic Surgery) is being used to describe such techniques, and     many have touted SILS as a major breakthrough in minimally-invasive surgery, moving the field     closer to surgery that is bloodless, incisionless, and painless. Despite the hype,     prospective comparisons of SILS versus conventional laparoscopy are lacking. Results of SILS     procedures have generally been limited to case reports and small case series that lack     controls. The investigators propose to conduct a prospective, randomized, single-center trial     of SILS appendectomy versus conventional laparoscopic appendectomy to treat acute     appendicitis. Primary end-points are operative time, complication rate, postoperative pain,     recovery time, and long-term cosmetic outcome. The investigators hypothesize SILS     appendectomy is equivalent to laparoscopic appendectomy with respect to operative time,     complication rate, postoperative pain, and recovery time while providing a better cosmetic     outcome.   "
239749|NCT00997529|"     A major focus of recent research has been the development of effective ways of sensitizing     the patient's immune system to recognize the cancer as foreign. Allogeneic stem cell     transplantation represents a novel way of potentially achieving this goal. There is recent     evidence that non-myeloablative allogeneic stem cell transplantation provides effective     therapy for patients with metastatic renal cell carcinoma. Based on the preliminary reports     from other investigators treating patient with breast and ovarian cancer, the investigators     of this study would propose treating an expanded cohort of patients with any metastatic solid     tumor.      The principal endpoints of the trial will include incidence of durable engraftment, quality     of hematopoietic and immune reconstitution, extent of donor chimerism, incidence and severity     of acute and chronic graft versus host disease (GVHD), and incidence of long-term disease     free survival (DFS). The investigators will evaluate the tumor response of patients with     stable or progressive disease post-transplant to donor lymphocyte infusions (DLI). The     investigators will also study the effects of DLI on T-cell immunity in the recipients.   "
239750|NCT00997542|"     The purpose of this study is to discover whether the inhibition of the xanthine oxidase with     allopurinol leads to a reduction of the production of oxygen free radicals in patients with     CHF and thereby improves characteristics of oxydative metabolism, peripheral blood flow,     immune function and functional status.   "
239751|NCT00997555|"     The investigators hypothesize that the scheduled use of bronchoscopy on a regular basis after     inhalation injury in burn patients will improve outcome by providing pulmonary hygiene,     decrease the incidence of pneumonia, and detect pneumonia earlier than standard treatment     without bronchoscopy.   "
239752|NCT00997568|"     The purpose of this study is to demonstrate the safety of the redesigned transesophageal     echocardiogram (TEE) transducer as it is inserted and transitioned into the esophagus through     the mouth.   "
239789|NCT00998049|"     Rationale: Giving colony-stimulating factors, such as G-CSF and plerixafor helps stem cells     move from the patient's bone marrow to the blood so they can be collected and stored.     Purpose: This phase II trial is studying how well plerixafor works in patients with multiple     myeloma previously treated with lenalidomide and planning to undergo autologous stem cell     transplant.   "
239753|NCT00997581|"     The purpose of the study is to learn about a possible new medicine, apremilast, for treating     acute gout and compare how it works to indomethacin, a medication that has been used to treat     gout for over 50 years.      In order to learn about apremilast, half the participants in this study will receive     apremilast and half the participants in this study will receive indomethacin.      This study will measure the severity and duration of acute gout attacks in research     participants, as well as measures of quality of life and any side effects or adverse     reactions to the medication.      There will be three study visits: a screening/baseline visit on Day 1, a visit to evaluate     response to treatment with study medication at Day 7, and a follow-up visit at Day 21.   "
239756|NCT00997620|"     The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed     thinking because of the hay fever will improve when treated with an effective anti-hay fever     medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate     better thinking.   "
239757|NCT00997633|"     SPECT was performed in 51 patients after cytoreductive surgery in combination with     intraperitoneal chemotherapy. The detected volume was compared to the number of subsequent     sequential postoperative intraperitoneal chemotherapy courses that could be performed without     further surgical intervention. SPECT data was found to predict feasibility of sequential     postoperative intraperitoneal chemotherapy.   "
239758|NCT00997646|"     To realize performance of a new system - hospitalist-run ward in Taiwan.   "
239759|NCT00997659|"     This research is to investigate the nutritional supplement chromium picolinate. A large     number of people use chromium picolinate from health food stores to improve the function of     the hormone insulin. The investigators are testing how effective this supplement is and are     also monitoring its safety. In patients with diabetes, chromium has been shown to increase     sensitivity to the hormone insulin. Since obesity can cause insensitivity or resistance to     insulin, the investigators are studying obese individuals with documented insulin resistance.     The investigators would like to know if chromium is also effective in treating the insulin     resistance associated with obesity.   "
239760|NCT00997672|"     The purpose of this study is to determine safety and tolerability of the treatment with     lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of     life and depressive symptoms, will be considered to further investigate the effect of lithium     therapy.   "
239761|NCT00997685|"     This is a single arm, open-label phase II study to evaluate the efficacy and safety of     Capecitabine plus oxaliplatin (XELOX) in the peri-operative treatment of patients with     potentially resectable liver metastasis from colorectal cancer.   "
239762|NCT00997698|"     This is a prospective observational registry with intent to detect the prevalence of     intracranial aneurysms with contrast-enhanced MR angiography (CE-MRA) at 1.5T, and to     determine the risk factors such as high blood pressure and cigarette smoking relating to     intracranial aneurysms.   "
239763|NCT00997711|"     The purpose of this study is to evaluate the safety and performance of the CYPHER SELECT™+     Sirolimus-eluting Stent (SES) in Asian diabetic patients.   "
239764|NCT00997724|"     The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted     thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell     lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If     success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures     for non-small cell lung cancer.   "
239765|NCT00997737|"     The objective of the present study is to evaluate diaphragm activity during three breathing     exercises: diaphragmatic breathing (DB), flow-oriented (Triflo II)incentive spirometry and     volume-oriented (Voldyne) incentive spirometry.      Seventeen healthy subjects will be studied (8 man and 9 woman).   "
239766|NCT00997750|"     The purpose of this study is to determine whether nonsteroidal antiinflammatory drug     lornoxicam in combination with low dose aspirin (100mg/day) is effective and safe in patients     with Acute Coronary Syndrome without persistent ST-segment elevation.   "
239767|NCT00997763|"     The purpose of this study is to establish the safety and effectiveness of coronary stenting     with the Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment     of de novo coronary stenosis in patients with diabetic patients.   "
239768|NCT00997776|"     The purpose of this trial was to examine the effectiveness of a short-term leg strengthening     exercise program compared to attention control on improving leg strength, walking speed and     endurance, physical performance, and physical function one year after hip fracture.   "
239769|NCT00997789|"     The aims of this study were to evaluate the pharmacokinetic properties and bioequivalence of     two rebamipide preparations in healthy Korean male volunteers for generic substitution and to     evaluate the association between the genetic polymorphisms in ABCB1 gene (exon 21 and 26) and     rebamipide disposition.   "
239770|NCT00997802|"     The purpose of this study is to evaluate the sensitivity of computed tomographic colonography     (CTC) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of     colorectal cancer (CRC), using optical colonoscopy as the reference standard.   "
239786|NCT00998010|"     RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as temozolomide, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving bortezomib together with temozolomide and radiation     therapy may kill more tumor cells and allow doctors to save the part of the body where the     cancer started.      PURPOSE: This phase II trial is studying the side effects and how well bortezomib works when     given together with temozolomide and regional radiation therapy in treating patients with     newly diagnosed glioblastoma multiforme or gliosarcoma.   "
239787|NCT00998023|"     The purpose of this research study is to collect information on the amount of discomfort     patients experience with one of two different vascular blood vessel closure devices, the     MynxM5 Vascular Closure Device and the Angio-Seal Evolution Vascular Closure Device.   "
239790|NCT00998062|"     The present project is aimed at determining the prevalence of LDL-C <130 mg/dl with hsCRP     ≥2mg/l, and of HDL-C < 40 mg/dl in Spain together with the estimation of cardiovascular risk,     to analyze the contribution of measuring hsCRP for primary prevention purposes. In a subgroup     of that population a number of inflammatory and oxidative status biomarkers would be also     measured to better understand the meaning of elevated hsCRP.The study aim to analyze data     already collected in studies (11 studies will participate) carried out in Spain, in 10     Spanish regions, after the year 2000.   "
239791|NCT00998075|"     The purpose of this study is to investigate whether treatment with a combination capsule of     Esomeprazole 40 mg and Aspirin (ASA) 325 mg is bioequivalent (i.e.has the same effect within     the body) as these medications taken separately. Two different forms of esomeprazole (tablets     and capsules) will be investigated.   "
239771|NCT00997815|"     The main purpose of this study is to determine the efficacy of intralesional botulinum toxin     type A injection for recalcitrant alopecia totalis and alopecia universalis.      Treatments of recalcitrant alopecia totalis and universalis remains an challenge issue for     medical practice.The application of diphenylcyclopropenone (DPCP) is still being an standard     treatment for the condition, however, there are at least thirty percentage of patients     recalcitrant to this treatment.      The complete etiology of this disease has yet to be clear.Nevertheless,recent studies have     demonstrated the hypothesis of neurotransmitter involvements.      There is numerous evidence in support of an imbalance of transmitters, including substance P     and Calcitonin gene-related peptide.      Botulinum toxin A injection has been used to treat a neuralgiform headache and diffused     alopecia areata. Both headache and hair loss have been made much in improvement. This data     may support the neurotransmitter imbalance theory.      The investigators have been informed about possible effects to the alopecia condition,     therefore, this study is conducted to assess the efficacy of botulinum toxin A as the novel     treatment for recalcitrant alopecia totalis and alopecia universalis.   "
239772|NCT00997828|"     The purpose of this study is to determine whether the safety and efficacy of coronary stent     implantation using Everolimus-Eluting Coronary Stent System (Abbott, Boston Scientific) is     not inferior to coronary artery bypass grafting (CABG) for the treatment of patient with     multivessel coronary artery disease (CAD).   "
239773|NCT00997841|"     The purpose of the study is to determine the efficacy of two different algorithms for     coagulation management in patients undergoing cardiac surgery suffering from increased     bleeding tendency. Algorithm 1 is based on conventional coagulation analyses (INR, aPTT,     platelet count, fibrinogen concentration,...) and Algorithm 2 is based on thrombelastometry     using the ROTEM-device and impedance aggregometry using the Multiplate device.   "
239774|NCT00997854|"     Doctors have tried many different methods of feeding to try to decrease feeding intolerance     in preterm babies so that they spend less time receiving liquid nutrition and have fewer     problems with feeding intolerance.      The purpose of this study is to test two different methods of feeding preterm babies in the     hopes of identifying a method that will decrease some of the feeding intolerance that can     occur when feeding premature babies.   "
239775|NCT00997867|"     This is a research study to determine if the effects of continuous peripheral nerve blocks     are influenced by the distance of insertion past the needle tip of the perineural catheter.   "
239776|NCT00997880|"     The purpose of this study is to evaluate the effect of statin therapy on the modification of     atherosclerotic plaque composition and vulnerability in non-intervened coronary arteries with     mild to moderate stenosis using VH-IVUS and OCT.   "
239777|NCT00997893|"     The purpose of this study is to examine the effects of soy (NovaSoy®) and estrogen on     menopausal symptoms such as hot flashes, sleep disturbances, and mood alteration in     perimenopausal women.   "
239778|NCT00997906|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine hydrochloride,     carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy my kill more     tumor cells. It is not yet known whether giving cisplatin together with radiation therapy is     more effective with or without gemcitabine hydrochloride, carboplatin, and paclitaxel in     treating patients with nasopharyngeal cancer.      PURPOSE: This randomized phase II/III trial is studying how well giving cisplatin together     with radiation therapy works compared with giving cisplatin and radiation therapy together     with gemcitabine hydrochloride, carboplatin, and paclitaxel in treating patients with locally     advanced nasopharyngeal cancer.   "
239779|NCT00997919|"     This Phase I, single-dose, randomized, parallel-group, open-label study will evaluate the     safety, tolerability, and pharmacokinetics of MABT5102A following subcutaneous (SC) and     intravenous (IV) administration in healthy volunteers.   "
239780|NCT00997932|"     This is a prospective clinical trial of ultrasound guided intrauterine contraception     insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month     follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.      The objective of this study is to measure intrauterine device (IUD) expulsion and the     feasibility of conducting a future clinical trial to evaluate placement of the     levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.   "
239781|NCT00997945|"     The purpose of this study is to assess the pharmacokinetics of single and multiple doses of     10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies.   "
239782|NCT00997958|"     Mycophenolate Mofetil (CellCept) is an FDA approved, well tolerated, oral medication used to     prevent the body's immune system from attacking transplanted organs. It has never been     studied in patients with pancreatic cancer but some preliminary studies have shown that it     may antagonize tumor growth. The goals of this study are to find out how much of this drug     can safely be taken by patients with advanced pancreatic cancer and to assess the variation     of the level of the drug in the blood. Patients will take the drug twice a day at a given     dose and the safety of the drug will be monitored through patient symptoms and blood tests.     The disease burden will be assessed by radiographic studies at the beginning and end of the     study. The patient will take the drug for a total of eight weeks.   "
239783|NCT00997971|"     The purpose of this study is to assess growth and global tolerance in healthy new born     infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental     partially hydrolyzed rice protein infant formula.   "
239784|NCT00997984|"     The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1,     2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children     with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.   "
239785|NCT00997997|"     This international, prospective, non-interventional, non-controlled observational study     obtains data on efficacy, safety and tolerability of Avelox treatment under daily-life     treatment conditions. Specifically investigated are the improvement of clinical symptoms and     the duration until infection improvement and cure.Any patient with a diagnosis of complicated     skin and skin structure infection (cSSSI) treated with Avelox can be documented. The     observation period for each subject covers the treatment period with Avelox. For each     patient, the physician documents data at an initial visit and one or two follow-up visit(s)     in line with routine practice.   "
239792|NCT00998088|"     Aim: to investigate whether the use of several transfusion alternatives (erythropoietin, the     cell-saver or postoperative drainage and reinfusion systems) in patients undergoing elective     total knee or hip replacement surgery can lead to allogeneic red blood cell (RBC) saving if a     restrictive transfusion policy is used.      Study design: a prospective, double randomized, open, multicenter study in which patients are     stratified according to their preoperative hemoglobin(Hb) level: stratum I= Hb between 6,1     and 8,2 mmol/l. These patients are first randomized for Erythropoetin (Epo) or no Epo.      Stratum II= Hb of 6,1 and lower or 8,2 mmol/l and higher, are not eligible for Epo and thus     not randomized. Patients in both strata will be randomized for three modalities: a cell saver     (CS)(to wash, filter and reinfuse autologous shed blood) which is used intra- and     postoperatively or a postoperative autologous reinfusion drainage system (D) only (to filter     and reinfuse autologous shed blood) or a restrictive transfusion trigger only (controls).      Inclusion criteria: All orthopedic patients of 18 years and older being considered for a     primary or revision total knee- (TKR) or total hip replacement (THR).      Outcome measures:      Primary outcome: number of allogeneic red blood cell (RBC) transfusions.      Secondary outcome: transfusion reactions, rehabilitation time, length of hospital stay     (days), peri- and post-operative complications during hospitalization, quality of life, cost     analysis   "
239793|NCT00998101|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and ixabepilone, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as cetuximab, can block cancer growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry cancer-killing substances to them. Giving chemotherapy together with     monoclonal antibodies may be a better way to block cancer growth.      PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin and     ixabepilone together with cetuximab works in treating patients with stage III or stage IV     non-small cell lung cancer previously untreated with chemotherapy.   "
239794|NCT00998114|"     The project aims to investigate the effect of a regular exercise for 6 months on diastolic     parameters in patients who present with shortness of breath and who have evidence of early     diastolic dysfunction on echocardiography. Patients will be enrolled from the VA General     Medicine and Cardiology Clinics, and will be screened for diastolic dysfunction. Once     enrolled, they will be on an exercise regimen that involves aerobic exercise for 30-45     minutes five times a week at home. The participants will have an initial supervised exercise     session with the VA Cardiac Rehabilitation team, and will have either every other week or     monthly supervised sessions at the VA Cardiac Rehabilitation Center to monitor their     progress. Clinical, biometric, laboratory and echocardiographic parameters will be obtained     before and after the 6 month period.   "
239795|NCT00998127|"     The purpose of this observational research study is to determine when and why patients     discontinue, interrupt, or disrupt the regimen of anti-platelet medications prescribed     following stent implantation, and to examine the relationship between specific patterns of     non-adherence and patient outcomes.   "
239796|NCT00998140|"     Resuscitative efforts have been shown to be unsuccessful in most cases of out-of-hospital     cardiac arrest (OHCA), and survivors who do recover cardiac function often sustain severe     hypoxic brain damage. Time to efficacious care is a primary determinant of disability-free     survival. In the Jerusalem district, only 9% of OHCA patients present with ventricular     tachycardia/ventricular fibrillation (VT/VF) as the primary rhythm, whereas 77% present with     asystole; this seems primarily to be the result of long collapse-to-arrival times.     Nevertheless, overly zealous resuscitation is undertaken in a high proportion of arrests with     a futile prognosis, leading to excessive costs.      Study hypotheses:        1. Subpopulations for whom intervention is futile/counter-productive are identifiable        2. Substantial waste of resources can be avoided        3. Optimization of emergency medical services (EMS) reorganization without adding resources          is an achievable goal   "
239797|NCT00998153|"     The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which     integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors     in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually     assaulted youth, and 3) psychoeducation strategies for prevention of risky sexual behaviors     and revictimization. The principal purpose of this research proposal is to evaluate the     efficacy of RRFT in reducing the risk of drug abuse and other risky behaviors, PTSD, and     revictimization among adolescents who have been sexually assaulted. The Research Plan will be     conducted based on Stage 1a and Stage 1b from NIDA's Behavioral Therapies Development Program     as described in Rounsaville, Carroll, & Onken (2001). The final phase of the research will     involve conducting a pilot randomized controlled trial of RRFT in a sample of adolescents,     comparing primary outcome measures of youth receiving RRFT to youth receiving usual care in     the community. Participants will be adolescents (12-17 years) who have experienced a sexual     assault. Assessment of substance use and other risk behaviors, trauma-related     psychopathology, and incidents of revictimization will be collected at pre- and post-     treatment, as well as 6-week and 3-month follow-ups. Hierarchical Linear Modeling will be the     primary method used to test study hypotheses. Development and evaluation of the proposed     intervention will have significant implications for addressing public health problems in     adolescent substance abuse and related high risk behaviors.   "
240661|NCT01005498|"     The purpose of the clinical trial is to investigate whether low carbohydrate diet is better     than the traditional diabetic diet in the treatment of patients with diabetes mellitus type     2, for blood sugar and body weight.   "
239798|NCT00998166|"     In the past, patients with advanced lung cancer who were inoperable underwent chemotherapy     with one or more chemotherapeutic agents. More recently, novel new agents targeting specific     enzymes or pathways responsible for cell division have been developed and clinicians have     begun to utilize various combinations of these drugs with standard chemotherapeutic agents     for the treatment of NSCLC. Some of these approaches have demonstrated a small but     significant increase in survival among patients with advanced disease. Because a recently     completed Phase 3 study of bevacizumab + Taxol/Carboplatin in first line NSCLC therapy     demonstrated a 23% improvement in median survival, it would be appealing to see if a regimen     of bevacizumab/ cisplatin/Alimta would also demonstrate a similar, or perhaps better,     response rate.   "
239799|NCT00998179|"     This study aims to investigate the effect of Acu-TENS on forced expiratory volume in one     second (FEV1), a test of pulmonary function used to assess airway resistance, during     sub-maximal treadmill exercise in healthy subjects.   "
239800|NCT00998192|"     The purpose of this Phase 2 study is to investigate whether intravenous administration of     REOLYSIN therapeutic reovirus in combination with paclitaxel and carboplatin is effective and     safe in the treatment of squamous cell carinoma of the lung.   "
239801|NCT00998205|"     The heart becoming stiff due to increased fibrous tissue or decreased elasticity of the     heart tissue is one of the earliest changes caused by heart failure. These changes can be     detected by simple non-invasive echocardiogram techniques. However, these techniques usually     detect the increased stiffness of the heart only after it has progressed to a significant     extent. The investigators hypothesize that if they stress the heart using a Dobutamine     infusion and measure the filling pressure using echocardiogram, it will provide them with     tools to identify these changes earlier.   "
239802|NCT00998218|"     The purpose this investigation is to more thoroughly investigate the effects of ranolazine on     arrhythmias and microvolt t-wave alternans in patients who have an automatic implantable     cardioverter defibrillator (AICD) implanted either prophylactically to prevent sudden cardiac     death, as well as in patients who may have had a clinically significant arrhythmic event     prompting the insertion of the automatic implantable cardioverter defibrillator. It is     anticipated this study will provide valuable new insight into the potential use of ranolazine     to treat arrhythmias in higher risk patients.   "
239803|NCT00998231|"     Major Depressive Episode (MDE) affects nearly 15% of the general population. In a preliminary     study, the investigators identified 12 genes whose expression was either altered between     patient and control samples and/or between first patient samples and samples from the same     patients obtained 8 weeks later. However, this study did not assess evolution of these     alterations beyond an 8-week window and only 2 time points were considered. The investigators     aim to compare gene expression difference for 21 candidate genes, of which 12 were already     investigated, in 2 groups of subjects. MDE and control samples will be analyzed across a     large time window to draw a better picture of the complex progression during MDE.   "
239804|NCT00998244|"     The purpose of this research study is to learn if a very low carbohydrate (sugar) diet or     traditional low fat diet is able to reduce symptoms related to gastroesophageal reflux     disease (GERD) in people who are overweight. Patients with GERD may experience all or some of     the following symptoms: stomach acid or partially digested food re-entering the esophagus     (which is sometimes referred to as heartburn or regurgitation) and belching. In this study,     the investigators also hope to find out if acid in the esophagus is reduced more by a low     carbohydrate diet than a low fat diet.   "
239805|NCT00998257|"     The objective of this Post Marketing Surveillance (PMS) is to gain information about safety     and efficacy in real practice.   "
239806|NCT00998270|"     A prospective, randomized trial of autologous bone marrow transplantation compared with     allogeneic bone marrow transplantation in multiple myeloma.   "
239807|NCT00998283|"     -  Study Design             -  Randomized, Double-blind, Placebo-controlled, escalating single-dose design.             -  Five ascending dose cohorts.             -  In each cohort, subjects will be randomized to receive a single dose of HM10460A or               placebo (negative control)        -  Objectives             -  The primary objective of the study is to assess the safety and tolerability of               single escalating subcutaneous doses of HM10460A in healthy adult Korean Subjects   "
239808|NCT00998296|"     The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the     combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide     dosing recommendation for subsequent phase II trials in patients with metastatic cancer.   "
239809|NCT00998309|"     To collect the efficacy and safety information of Zithromax-SR related to their appropriate     use in daily practice.   "
239810|NCT00998322|"     The purpose of this Phase 2 study is to investigate whether intravenous administration of     REOLYSIN therapeutic reovirus in combination with gemcitabine is effective and safe in the     treatment of patients with advanced pancreatic cancer.   "
239811|NCT00998335|"     The optimal insulin therapy in T2DM is controversial and its impact on nonalcoholic fatty     liver disease (NAFLD) has not been systematically studied before, and in particular, never     when using the new insulin formulations detemir (Levemir®) or aspart (Novolog®). This study     is to determine the effect on hepatic steatosis and insulin secretion/action of lowering the     fasting plasma glucose (FPG) to target with once daily basal insulin detemir alone or     combining insulin detemir with premeal insulin aspart in patients with uncontrolled type 2     diabetes mellitus (T2DM).      In the first 3 months the investigators will optimize metabolic control in all patients with     intensive basal (bedtime) detemir insulin aiming at a normal fasting plasma glucose. After     this treatment period, patients will be randomized in the second 3 months in a 2:1 ratio to     insulin detemir or detemir plus aspart. The investigators propose that insulin will improve     day-long glycemic control and A1c, reduce hepatic steatosis (NAFLD) (primary endpoint) and     insulin secretion/sensitivity being well tolerated while causing minimal weight gain and     hypoglycemia (secondary endpoints). The study will allow to assess if there is an additional     benefit of adding pre-meal rapid-acting insulin aspart to basal insulin to these endpoints.   "
239812|NCT00998348|"     This purpose of this project is to determine whether this 8-month parenting for healthy     weight intervention is able to help parents improve their parenting skills and make positive     changes in the nutrition and physical activity environment at home.   "
239813|NCT00998361|"     This is a perspective multicentric study for the treatment of patients aged equal or less     than 60 years and submitted to an allogeneic hematopoietic stem cell transplantation from an     HLA compatible related or unrelated donor because affected by resistent or refractory or     relapsed after autologous stem cell transplantation Ewing Sarcoma or Soft tissues sarcoma who     did not benefit from conventional therapy.   "
239886|NCT00999323|"     The objective of this study is to evaluate whether impaired endothelial function and low     heart rate variability are associated with clinical restenosis after percutaneous coronary     intervention with stent implantation in patients with angina or acute coronary syndrome.      Furthermore, the study examines a potential correlation between biomarkers of endothelial     cell activation and endothelial dysfunction.   "
239814|NCT00998374|"     This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that     rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes     reactive hypoglycemia. It is believed that the controlled release offered by an intact     pylorus will be advantageous for long term results in bariatric surgery. This study can     provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery,     such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as     compared to non-pyloric sparing surgery, namely the gastric bypass.   "
239815|NCT00998387|"     The purpose of this study is to translate and validate the CAM-ICU for use in the Korean ICU     setting.   "
239816|NCT00998400|"     Emotional states of depression in association with ischemic heart diseases, such as     myocardial infarction or unstable angina, are risk factors for subsequent cardiac events and     mortality. However, the only psychological intervention trial attempting to reduce cardiac     risk in depressed ACS patients showed that changes in depression did not translate into     improved survival. Such intervention did not address issues such as lifestyle modification     and improvement in psychological well-being, which were found to affect individual     vulnerability to medical disease. Our research group has developed a well-being enhancing     psychotherapeutic strategy, well-being therapy (WBT), which has been validated in a number of     clinical trials. The aim of this project is to evaluate the efficacy of cognitive behavioral     treatment (CBT) together with lifestyle modification and WBT in reducing cardiac risk in     depressed and/or demoralized ACS patients compared to a standard clinical procedure of     patients' management, the clinical management (CM). The same protocol will be carried out in     two centres (Bologna and Torino). 100 patients after a first episode of myocardial infarction     or unstable angina, meeting DSM-IV criteria for depressive disorders and DCPR criteria for     demoralization will be randomized to one of two treatment groups: 1) CBT supplemented by     lifestyle modification and WBT; 2) CM. In both groups, treatment will consist of twelve,     45-minute sessions once a week. A two-year follow-up will be performed. It is expected that     psychological treatment may significantly decrease cardiac morbidity and mortality at     follow-up compared to clinical management. The findings may entail considerable preventive     implications and possible large reductions in health costs.   "
239817|NCT00998413|"     The purpose of this study is to determine the efficacy of a multifactorial intervention with     weight reduction, behavioural therapy, and physical exercise on the severity and control of     asthma in obese children.   "
239818|NCT00998426|"     HepaGam B Hepatitis B Immune Globulin (HBIG) solution contains 10% maltose, which could     possibly interfere with the measurement of glucose levels when using glucose non-specific     tests. The purpose of this study is to determine whether use of HepaGam B HBIG shows an     increase in glucose levels in the body using non-specific glucose monitoring, as well as     specific glucose monitoring. The sponsor believes that this medication will not cause a     significant increase in glucose levels in the body when measured by glucose non-specific     tests.   "
239819|NCT00998439|"     The aim of the study is to assess the efficacy of the Paclitaxel-eluting PTCA - balloon     catheter SeQuent® Please to treat in-stent restenoses (ISR) of various drug eluting stents in     native coronary arteries with reference diameters between 2.5 mm and ≤ 3.5 mm and lesion     lengths ≤ 22 mm. The vessel patency following treatment with SeQuent® Please will be     documented in ISR patients that have been treated with the Cypher® or Taxus® drug eluting     stent.   "
239820|NCT00998452|"     This study is being conducted with the Veterans Affairs National Center for Health Promotion     and Disease Prevention (VANCP), which is overseeing the current dissemination of MOVE!     (Managing Overweight/Obesity for Veterans Everywhere), a national weight management program     for veterans. It will be based at 10 local sites in the national network of VA medical     settings and community-based outpatient clinics and will compare two different models for     disseminating and implementing MOVE! using a randomized experimental design. One study arm     will implement the MOVE* VETS! (Volunteer Education and Tailored Self-management and support)     model that includes tailored newsletters and peer counseling MI calls and activities, and the     other will receive the standard MOVE! program.   "
239821|NCT00998465|"     The purpose of this study is to evaluate the effect of high vs. low sodium intake on blood     pressure and system hemodynamics in patients with morbid obesity and to evaluate the impact     of laparoscopic gastric bypass on blood pressure, salt sensitivity and body composition in     morbidly obese patients. Furthermore, we wants to describe the hemodynamic mechanisms     involved in the amelioration of blood pressure during long-term weight loss.   "
239822|NCT00998478|"     The purpose of this study is to investigate the effects of a cross-curricular physical     activity intervention on cardiovascular disease risk factors in 11-14 year olds. The null     hypothesis states that the intervention will have no effect on cardiovascular disease risk     factors.   "
239823|NCT00998504|"     There is now a general consensus that the combination of excessive energy intake and a low     capacity to oxidize fat will lead to muscular fat accumulation and insulin resistance. It is     known for many years that physical exercise is the most powerful treatment to combat insulin     resistance, but it is also known that it is difficult to get people to exercise. A major     breakthrough has come from the nutrition field, with the finding that resveratrol, a natural     polyphenolic compound, could serve as an exercise mimetic by protecting mice from many     detrimental effects of diet-induced obesity. Therefore the researchers would like to     investigate if resVida can increase skeletal muscle mitochondrial function and fat oxidative     capacity in obese subjects. The researchers hypothesize that an increased mitochondrial     function together with an increased intrinsic activity will lead to a better control of fatty     acid handling in muscle, upon a high-fat challenge.   "
239824|NCT00998517|"     The purpose of this study is to compare the recovery rates of moderately malnourished     Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified     spread or a commercially produced ready-to-use therapy food.   "
239887|NCT00999336|"     The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and     tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to     healthy volunteers.   "
240379|NCT01002924|"     This extension protocol is for those subjects that have completed the allowed duration of     participation in an Endocyte-sponsored clinical trial of EC145 (vintafolide) and have     continuing evidence of clinical benefit (stable disease or better) at the time that they     completed participation in that study.   "
239825|NCT00998530|"     The hypothesis to be tested in this trial is that the different epidemiologic (including     racial differences) and phenotypic manifestations exhibited by Trichomonas clinical isolates     during infection are correlated with their genotypic strain classification. Two specific aims     are proposed to test that hypothesis. Specific aim 1. Assess the significance of genotypic or     phenotypic differences in the Trichomonas strains among African American women by HIV status.     Specific aim 2. Determine the significance of genotypic or phenotypic differences in the     Trichomonas strains circulating among women from two different racial groups, African     American women and Caucasian women. The overall goals of these specific aims are to identify     racial differences in the genotypic and phenotypic characteristics of Trichomonas strains,     and to develop the ability to identify and classify Trichomonas infections in order to     prioritize treatment and epidemiologic follow-up of individuals infected with isolates     associated with adverse clinical outcomes (HIV transmission or acquisition, pregnancy     complications, virulence, or drug resistance).   "
239826|NCT00998543|"     The purpose of this study is to provide long-term follow-up immunogenicity and safety data on     participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04     (NCT 00258947).      Primary Objectives:      Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years     post-vaccination.      Safety: To follow-up the long-term safety up to 5 years post-vaccination.   "
239827|NCT00998556|"     This is a randomized, controlled clinical trial to evaluate the efficacy and safety of     bromocriptine for improvement of left ventricular function of women with Peripartum     cardiomyopathy (PPCM). A Multi center trial in Germany.   "
239828|NCT00998569|"     The purpose of this study is to examine the effects of neurocognitive enhancement on     cognitive abilities and related social and adaptive behaviours in individuals diagnosed with     major depressive disorder. Subjects in this study will be randomized to receive     Neurocognitive Enhancement Therapy (NET) or to a wait list and then NET . Secondary aims     include examining whether the cognitive benefits are potentiated by repeated exposure during     in-home practice with complementary exercises. Additionally, the investigators will examine     the durability of the effects and their generalization to functional capacity and everyday     functional performance after completion of the groups.   "
239829|NCT00998582|"     Recent research as suggested that use of the HIV medication abacavir (Ziagen, or     co-formulated with lamivudine as Epzicom) may increase risk for heart disease, though     findings from multiple studies have been inconsistent. This pilot study will examine vascular     function, a marker of heart disease risk, among patients taking abacavir as part of their HIV     medications and are then randomized to: 1) switch to tenofovir, another HIV medication, or 2)     continue to take abacavir.   "
239830|NCT00998595|"     The primary hypothesis underlying this proposal is that the introduction of a Promotora to     provide education and proactive follow-up to women with GDM will increase compliance with     postpartum glucose tolerance testing. The secondary hypothesis is that the Promotora will     improve participation in referral visits for diabetes or preventive care. We will develop the     promotora program and begin pilot implementation.   "
239831|NCT00998608|"     The purpose of this study is to compare the efficacy and safety of risperidone and     risperidone plus low dose of haloperidol in the acutely schizophrenic patients.   "
239832|NCT00998621|"     Main objective: To study and validate a questionnaire measuring treatment adherence in     patients with Hepatitis C virus (HCV) infection.      Design of the study: Multicentric, prospective, epidemiological study in the field of usual     clinical practice.   "
239833|NCT00998634|"     The purpose of this study is to determine safety and tolerability of the treatment with     lithium in Spinocerebellar Ataxia 2. Moreover, clinical symptoms, neuronal loss, quality of     life and depressive symptoms, will be considered to further investigate the effect of lithium     therapy.   "
239834|NCT00998647|"     The purpose of this study is to find out, whether filtration of the blood in patients     undergoing cardiac surgery, beneficially influences the coagulation system.   "
239835|NCT00998660|"     The purpose of this study is to assess the recharge feature of the Activa RC System in     patients who are receiving Deep Brain Stimulation (DBS) for Parkinson's Disease (PD),     Essential Tremor (ET), or dystonia.   "
239836|NCT00998673|"     Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue     growth and enhanced wound healing for all types of chronic wounds. It is applied as patch and     will be hold in place by a secondary dressing for maintaining the moist wound environment.     The study is aimed to demonstrate superiority over a standard wound treatment for chronic     venous leg ulcers. The primary efficacy variable is time to healing.   "
239837|NCT00998686|"     The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over     52 weeks.   "
239838|NCT00998699|"     The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell     regeneration.      The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and     insulin production.   "
239839|NCT00998712|"     The purpose of this research study is to look at whether there are differences in blood     vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels,     and levels of other blood markers between black women and white women who have or do not have     gestational diabetes mellitus.   "
239840|NCT00998725|"     The purpose of this research study is to learn about the birth control pill called LoFemenal     in HIV+ and HIV negative women who live in Malawi. This is a pilot study to determine the     effect of antiretroviral therapy on the pharmacokinetics of the most commonly used oral     contraceptive in HIV+ women; and to measure ovulation suppression in women taking the oral     contraceptive pill and antiretroviral therapy at the same time. Nine women will be enrolled     and will be followed for a total of 4 months.   "
239841|NCT00998738|"     This randomized phase III trial studies calcium and magnesium to see how well they work in     preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer. Giving     calcium together with magnesium may stop or delay the development of peripheral neuropathy in     patients with cancer who are receiving treatment with ixabepilone. It is not yet known     whether calcium and magnesium are effective in preventing peripheral neuropathy caused by     ixabepilone.   "
239842|NCT00998751|"     The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the     treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.   "
239844|NCT00998777|"     The primary purpose of this study is to assess changes in shoulder muscle strength, shoulder     movement, shoulder flexibility, muscle thickness, upper arm torsion angle, and subacromial     width (space where the rotator cuff muscle passes through) after completing a 6-week shoulder     strengthening and stretching program in division I collegiate swimmers. The result of this     study may demonstrate the effectiveness of a strengthening and stretching program to     positively influence factors that have been associated with pain and injury in division I     collegiate swimmers and indicate the need to implement this program for the entire team.     Following a 6-week strengthening and stretching program, it is believed that scapular     kinematics, shoulder flexibility, and shoulder and scapular stabilizer strength will be     improved compared to control subjects.   "
239845|NCT00998790|"     A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence.     The purpose of this study is to obtain surgical technique data for use in physician education     and training and to collect early clinical outcomes data for future publication. This study     is not designed to statistically demonstrate safety and efficacy of the device.   "
239846|NCT00998803|"     Influenza virus infections are a major cause of morbidity and mortality. The limited existing     knowledge about the impact of influenza in immunocompromised patients suggests that they are     at increased risk of influenza virus acquisition, of developing complications and of     prolonged illness and viral shedding. However, some other data about the effect of antiviral     agents on the infection course, and risk of resistance in immunocompromised children are     lacking. The emergence of the pandemic H1N1 swine-origin influenza A virus has generated an     additional need to study the epidemiology, clinical course and outcome of influenza     infections in immunocompromised children. This study proposed to conduct a prospective     observational clinical study to answer these questions.   "
239847|NCT00998816|"     Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the     likelihood of chronic post-thoracotomy pain syndrome (CPTPS).   "
239848|NCT00998829|"     This study aims to collect Australian data on the prevalence of undiagnosed psoriatic     arthritis in patients with plaque psoriasis. In addition the study will assess disease     severity and quality of life in Australian patients with psoriasis attending specialist     dermatology clinics.   "
239849|NCT00998842|"     To determine if there is a difference between wireless ECG and wired ECG findings.   "
239850|NCT00998855|"     A 12 wk aerobic exercise program will reduce visceral, hepatic and intramyocellular fat     accumulation and improve insulin sensitivity and glucose metabolism in obese sedentary     Hispanic adolescents.   "
239851|NCT00998868|"     The purpose of the study is to evaluate the prevalence of rotator cuff tears in the shoulders     of hemiplegic patients of different severity.   "
239852|NCT00998881|"     The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in     patients with type 2 Diabetes for 12 weeks administration.   "
239853|NCT00998894|"     The investigators propose to test the theory that smart alarms for the Triple Low State     incorporated into a decision support system built into an electronic anesthesia record will     prompt clinicians to intervene earlier in situations that would otherwise provoke little     concern, and that the alert system will reduce 90-day mortality. Specifically, the     investigators will test the hypothesis that providing Triple Low alerts reduces 90-day     mortality.   "
239854|NCT00998907|"     The aim of this study is to ascertain if the use of PDS plus® reduces the number of wound     infections and incisional hernia after midline and transverse laparotomy comparing to     polyglactin suture.   "
239855|NCT00998920|"     The purpose of this study is to evaluate the safety and tolerability of escalating multiple     doses of S-equol administered twice daily (BID) for 14 days to healthy male and female     subjects and to describe the pharmacokinetic profile of S-equol.   "
239856|NCT00998933|"     To further characterize the transfer potential of marketed testosterone gel and new 1.62%     formulation.   "
239857|NCT00998946|"     The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and     folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's     lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12     and folic acid in this patient population. Additionally, this study includes the collection     of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient     population (PK is the activity of a drug in the body over a period of time, including how the     drug is absorbed, distributed in the body, localized in the tissues, and excreted from the     body).   "
239858|NCT00998959|"     The purpose of this study is to determine the usefulness of a stress reduction treatment in     helping minority patients with major depression get better. Subjects will receive six weeks     of either mindfulness-based stress reduction and problem solving therapy or psychoeducation.   "
239859|NCT00998972|"     The goal of this study is to evaluate the effect of N-acetyl-cysteine (NAC) administration in     organ donors on the kidney graft function of recipients.   "
239860|NCT00998985|"     This multiple dose study will assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)-     infected participants. The primary hypothesis is that administration of grazoprevir for 7     days is sufficiently safe and well tolerated in HCV-infected males.   "
239861|NCT00998998|"     The purpose of this study was to determine if a home-based intervention to foster child     development improved behavior and development in infants with IDA.   "
239862|NCT00999011|"     This study will examine the effects of once and twice daily activity performed with patients     who are breathing with the aid of a machine in an intensive care unit. Activity can occur in     bed. Activity can include transfer to a chair and even walking once the patient's condition     allows safe, out-of-bed activity. The investigators hypothesize that early, progressive     activity will reduce inflammatory molecules in the blood, promote muscle and physical health     and help patients to recover more quickly from critical illness.   "
239885|NCT00999310|"     The purpose of this study is to investigate the following:        1. Whether Klinefelter Syndrome is associated with altered total and regional brain volumes          and altered brain activity.        2. The influence of genetic factors and testosterone treatment on the neuropsychological          phenotype, total and regional brain volumes and brain activity in men with Klinefelter          syndrome.   "
239863|NCT00999024|"     An adequate oxygenation and retinal perfusion is essential for the function of the inner     retina. There is a wide range of autoregulation mechanisms to ensure a sufficient ocular     blood and oxygen supply during changes in systemic blood pressure or intraocular pressure     (IOP). Nonetheless, various retinopathies such as diabetic retinopathy, which is the leading     cause of blindness in people aged 20-65 in the western world, are highly associated with     hypoxia (Pemp and Schmetterer 2008). Hence, measurements of oxygen levels in retinal vessels     are needed to further our understanding of these ischemic diseases. It is a well known fact     and a commonly employed method to measure oxygen saturation of blood through light     transmission (Kramer 1934). However, this approach is not feasible in the human eye.     Therefore, reflection must be used, meaning the amount of incident light must be estimated     based on the amount of light reflected (for a review see Harris 2003). This is a difficult     task and investigators in this field have encountered several problems, including optical     complexities, nonlinear sensors and eye movement (Beach et al 1999; Delori 1988). Nonetheless     considerable progress has been made over the past decades and the development of an reliable     oximeter reported (Hardarson et al 2006).      In the present study this technique will be applied in healthy subjects as well as in     patients with COPD during room-air conditions. The procedure takes approximately 15 minutes     in each subject and will be performed in only one eye.   "
239864|NCT00999037|"     FGF-23 is a newly described protein that is an important regulator of phosphorus in the body.     This protein increases in people with kidney disease and people who need dialysis have very     high levels of FGF-23 in the blood. However, although some studies have indicated that FGF-23     levels go up with increased intake of phosphorus, no one knows if FGF-23 levels can be     lowered in patients with kidney disease by preventing them from absorbing phosphorus from     food. This study is designed to see what happens to levels of FGF-23 in the blood when     patients with chronic kidney disease take medications to prevent phosphorus absorption. Since     high levels of FGF-23 have been linked with increased rates of death in patients with     advanced kidney disease, controlling the levels may, in the future, be a way to decrease     heart disease in patients with kidney disease.   "
239865|NCT00999050|"     The aim of this study is to evaluate the effect of Roux-en-y gastric bypass (RYGB) in     controlling diabetes in subjects with mild obesity (BMI 26-35). The primary endpoint will be     the reduction of HbA1c (< 7%), a standard measure of diabetes control; the secondary     endpoints will be changes blood sugar , vitamin levels, insulin, c-peptide, and lipids     levels, as well as retinal eye examinations, urinalysis to assess kidney function, carotid     ultrasound as a marker of cardiovascular function, and alterations in diabetic medications.     Fifty subjects with medically documented type 2 Diabetes Mellitus (T2DM) with BMIs between 26     and 35 will undergo standard laparoscopic RYGB. Prior and after surgery, the subjects will     undergo a clinical evaluation in regard to the primary and secondary endpoints listed. The     pre-surgery evaluation is directed toward establishing the existence of diabetes related     complications prior to surgery. After surgery subjects will be closely monitored for     complications and required changes in their diabetes management. Repeat assessments will be     made at 1, 3, 6, and 12 months and at two years.   "
239866|NCT00999063|"     This is a prospective , epidemiological, multi-centre, phase IV study, approximately 5,000     patients who suffer with upper gastrointestinal tract symptoms. Each patient will be assessed     for GERD with GerdQ Thai Version.   "
239867|NCT00999076|"     The aim of the study is to evaluate the polymerase chain reaction (PCR)-Reverse Blot     Hybridization Assay (REBA) for identification of nontuberculous mycobacteria (NTM) species in     acid-fast bacilli (AFB) smear-positive respiratory specimens.   "
239868|NCT00999089|"     The individual contribution of the specific injuring mechanisms surgical trauma,     extracorporeal circulation, and ischemia/reperfusion to clinical outcome in coronary     revascularisation remains to be elucidated. The effect of these factors is analyzed in this     randomized clinical trial by comparing the 3 surgical approaches: Conventional Coronary     Artery Bypass Grafting (CCAB), with extracorporeal circulation and cardioplegic arrest;     Off-Pump Coronary Artery Bypass Grafting (OPCAB), avoids extracorporeal circulation and     global myocardial ischemia; and Pump-Assisted Coronary Artery Bypass Grafting (PACAB), with     an unloaded and beating heart. The hypothesis addressed by the study is that the surgical     invasiveness increases in the order: OPCAB, PACAB, CCAB.   "
239869|NCT00999102|"     Beta-blockers are prescribed to millions of people for treatment of hypertension. Fatigue is     a recognized and common side effect of beta-blockers that can have significant effects on     quality of life. Worse, many people taking a beta-blocker for years are not even aware of the     reduction of energy with which they are living.      A new vasodilating beta-blocker, nebivolol, which is approved by the FDA for treatment of     hypertension, appears to be far less associated with fatigue than are most currently     available beta-blockers. The purpose of this study is to compare nebivolol with the current     best-selling beta-blocker, metoprolol, and determine whether there is a significant     difference in side effects including fatigue, reduced exertion tolerance, and reduced quality     of life.      In this study, 30 subjects will take each of the 2 study drugs for 8 weeks, consisting of 4     weeks at a lower dose, and 4 weeks ata higher dose. All dosages are FDA-approved for     treatment of hypertension. Subjects and investigators will not know which drug is being     administered until completion of the study. Subjects will undergo a treadmill stress test and     will complete fatigue and quality of life questionnaires after each 4 weeks of treatment. An     echocardiogram and non-invasive measurement of aortic blood pressure will be performed after     8 weeks on each drug. Also, blood will be drawn and stored for possible measurement of drug     levels, after 4 and 8 weeks on each drug. Results on each drug will then be compared. If     nebivolol is found to cause significantly less fatigue, it would be of substantial importance     to the many millions of people who are on life-long beta-blocker therapy, and are living with     reduced energy.   "
239870|NCT00999115|"     The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded     adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s     disease.   "
239871|NCT00999128|"     This is a Phase I, randomized, two-part, single-center pharmacokinetics (PK) study to assess     the relative bioavailability of capsule and tablet formulations of GDC-0941 in the fasted     state (Part 1) and to determine the effect of food and proton pump inhibition on the PK of     the tablet formulation of GDC-0941 (Part 2). Approximately 18 subjects will be enrolled in     Part 1 and up to 32 subjects will be enrolled in Part 2. Subjects who participate in Part 1     are not eligible to participate in Part 2.   "
239873|NCT00999154|"     Background:      - Obesity is the result of many factors, including genetics and lifestyle, such as     over-eating high-calorie foods and not being physically active. Obesity affects approximately     one third of adults in the United States. Researchers often study individuals who are already     overweight and obese, but another approach is to examine people who stay thin despite eating     whatever they want and not exercising. Studying these thin individuals will enhance     understanding of why some people become obese and others do not, which may lead to novel     treatments for obesity.      Objective:      - To study the metabolism, body composition, body temperature, physical activity, and blood     chemistries of healthy lean adults before and after adding 1,000 extra Calories per day to     their normal diet.      Eligibility:      - Healthy adults, 30 to 50 years of age, who have never been overweight after adolescence,     who are currently weight-stable, sedentary, and eating without restrictions.      Design:      - The entire study will take about 9 weeks and will include the following outpatient and     inpatient visits:      <TAB>- Outpatient screening visit and monitoring: Physical examination and blood test at     screening; then, one week of physical activity monitoring (e.g., with a pedometer-like device     called an accelerometer) and completing a food diary.      <TAB>- Baseline inpatient visit (5 days): Volunteers will eat a normal diet to maintain body     weight. Energy expenditure, body composition, physical fitness, activity level, and eating     behavior will be measured. Urine and blood samples will be taken. Volunteers may go home for     the weekend or stay at the metabolic clinical research unit (MCRU).      <TAB>- Inpatient feeding week 1 (5 days): Volunteers will eat a normal diet plus milkshakes     for added calories. All the same measurements during the baseline week visit will be     repeated.      <TAB>- Outpatient feeding weeks 2 3: Volunteers will eat breakfast at the MCRU everyday for     the next 2 weeks and take prepared meals home with them (volunteers may also stay at the MCRU     for the 2 weeks if they prefer). Volunteers will drink a non-radioactive (heavy) water called     doubly labeled water to measure energy expenditure in their normal living environment Daily     urine samples will be collected.      <TAB>- Inpatient feeding week 4 (5 days): Volunteers will continue eating a normal diet plus     milkshakes for added calories. This stay and measurement is identical to inpatient feeding     week 1.      - Volunteers will be contacted at 6 and 12 months to assess any changes in body weight, diet,     and physical activity.   "
239874|NCT00999167|"     This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of     an open label safety lead-in (Part A), followed by randomized, double-blind,     placebo-controlled treatment (Part B).   "
239875|NCT00999180|"     The objective of this study is to assess if the association of botulinum toxin type A and     kinesitherapy is superior to kinesitherapy and 0,9% saline for the functional performance in     post-stroke patients.      Hypothesis H(0): BT-A associated to kinesitherapy is not superior to kinesitherapy in the     function of hemiparetic post-stroke patients.      H(1): BT-A associated to kinesitherapy is superior to kinesitherapy in the function of     hemiparetic post-stroke patients.   "
239876|NCT00999193|"     Fractures of the proximal humerus are common in elderly patients. The optimal treatment of     comminuted, displaced fractures is subject to controversy, and the results of operative     treatment have not been shown to be superior to conservative treatment. The aim of the study     is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty     versus conservative treatment in a randomised, controlled protocol. The results of treatment     are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. Main outcome measures     are Pain at rest and activity (NRSs) and functional assessment of the shoulder with Constant     Score. Secondary outcome measures are Simple Shoulder test (SST), Disabilities of the Arm,     Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction     and costs. The study also has a cohort follow-up of the patiens who decline randomisation.   "
239877|NCT00999206|"     A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived     seasonal trivalent subunit influenza vaccine in adult and elderly subjects without     significant illnesses and to demonstrate consistency of the immunogenicity of the three lots     of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine     including assessment of non-inferior immunogenicity   "
239878|NCT00999219|"     This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by     polysomnography in patients with insomnia, excluding patients with schizophrenia or     manic-depressive psychosis.   "
239879|NCT00999232|"     The purpose of this study is to assess the effect of erythromycin on the Rate of Success in     Placement of a Self-propelled Feeding Tube.   "
239880|NCT00999245|"     Patient-Controlled Analgesia (PCA) means that the patient is in control of his/her pain     medicine. In this study two (2) different treatment plans of Patient-Controlled Analgesia     will be used to treat people with sickle cell disease who are admitted to the hospital for a     pain crisis. The purpose of this study is to find out if one plan is better than the other in     controlling sickle cell pain.      If you are eligible for the study, you will be assigned by chance (like flipping a coin) to     either get a higher continuous amount of the pain medicine with a smaller amount for pain as     you need it, OR to get a smaller continuous amount of pain medicine with a larger amount of     pain medicine as you need it. You or your study doctor can not choose which plan you receive,     and you will not be told which one you have been assigned to. The doctors and nurses taking     care of you will know which plan you are assigned to so they can safely and effectively take     care of your pain. Some members of the study team will not know which plan you are on.      We will give you morphine sulfate or hydromorphone (dilaudid) for your pain. These medicines     are approved by the Food and Drug Administration (FDA) and have been used for a long time to     relieve pain. If you have been treated for pain before with hydromorphone (dilaudid) and you     prefer it to morphine, then you may choose to get it during the study. If you have not     received hydromorphone (dilaudid) before or you do not have a preference then you will be     given morphine for pain.      The pain medicine will be given through the IV in your arm. You will receive morphine or     hydromorphone continuously through the IV and will also be able to use the PCA machine to     give yourself extra pain medicine as you need it for pain. You will need to push a button to     give yourself extra medicine for pain. The amount of pain medicine you get on these plans is     based on how much you weigh.   "
239881|NCT00999258|"     The objective of this study is to examine the effect on allograft function and histology of     converting African American renal transplant recipients with chronic allograft nephropathy     (CAN) from a tacrolimus-based regimen to a sirolimus-based maintenance immunosuppression     regimen.      The investigators hypothesize that the conversion from tacrolimus to sirolimus in African     American renal recipients will stabilize or improve renal allograft function, and stabilize     the histological progression of CAN. This conversion will have the potential to prolong     long-term graft survival in African American renal transplant patients.      GFR measurements, histological parameters on the allograft biopsy, as well as patient and     graft survival, incidence of acute rejection, and specific side effects will be monitored and     compared between the sirolimus conversion group and the patients who will be maintained on     tacrolimus.   "
239882|NCT00999271|"     The aim of this proposal is to examine whether endogenous GIP and exogenous GIP alone and in     combination with insulin affect gastric emptying (GE), appetite, energy intake, energy     expenditure (EE) and plasma levels of triglycerides (TAG), free fatty acids FFA) and glycerol     in man.   "
239883|NCT00999284|"     ZK 200775 is an antagonist at the α-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA)     receptor and had earned attention a possible neuroprotective agent in cerebral ischemia.     Probands receiving the agent within a stroke therapy related Phase I trial reported on an     alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system     will be analyzed in detail.      In a randomised, placebo-controlled, double-blind study eyes and vision will be examined     before and after the intravenous administration of ZK 200775. The following methods will be     applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute     threshold, central visual field, pattern-reversal visual evoked potentials (pVEP), ON-OFF and     full-field electroretinogram (ERG).   "
239888|NCT00999349|"     Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant,     hepatoprotective and iron chelating activities. The present study has been designed to     investigate the therapeutic activity of orally administered silymarin in patients with     thalassemia major under conventional iron chelation therapy. A 6-month randomized,     double-blind, clinical trial was conducted in 140 beta-thalassemia major patients in two     well-matched groups. Patients are randomized to receive a silymarin tablet (140 mg) three     times a day plus conventional desferrioxamine therapy or the same therapy but a placebo     tablet instead of silymarin. Clinical laboratory tests of iron status and liver function are     assessed at the beginning and the end of the trial.   "
239889|NCT00999362|"     The purpose of this study is to determine whether calcineurin phosphatase in the     T-lymphocytes is up-regulated after long-term treatment with tacrolimus, a calcineurin     inhibitor.   "
239890|NCT00999375|"     Background:        -  Type 1 diabetes (T1D) is a common chronic disease in children, occurring in          approximately 1 of every 400 to 600 children. Children with T1D are unable to produce          insulin, a hormone that allows the body to use glucose from food. Children with T1D          manage their diabetes by taking insulin, monitoring their blood glucose levels, and          watching their diet, including carbohydrates.        -  Carbohydrates come from many different kinds of food, and recent research has shown that          different foods have a different effect on the level of glucose in the blood. In          general, whole, unprocessed foods (e.g., fruits, vegetables, whole grains, legumes) have          a lower glycemic index (GI), which means that they cause smaller, more sustained blood          sugar levels. Additionally, these foods are rich in nutrients. Nutrient-poor          carbohydrates come from foods made with refined grains and sugars, such as breads,          crackers, and breakfast cereals; they general cause a more rapid increases in blood          sugar (i.e., a high GI). Lower GI diets may help people with T1D manage their blood          glucose levels more easily.      Objectives:        -  To determine the utility of a whole foods, low GI diet in the management of T1D.        -  To determine the utility of a behavioral intervention to promote healthful family          dietary behaviors, including eating more fruits, vegetables, whole grains, and legumes,          and fewer refined carbohydrates.        -  To determine how the dietary intervention affects quality of life, satisfaction with the          diet, and risk for problem eating behaviors.      Eligibility:      - Children 8 to 16 years of age who have been diagnosed with T1D for more than 12 months, and     who use insulin injections to maintain normal blood glucose levels.      Design:        -  Families will be divided into two groups: an intervention group that will participate in          intensive dietary intervention and continuous glucose monitoring (CGM) and a control          group that will not have the dietary intervention but will have CGM and scheduled          contacts with study staff.        -  Intervention group families will have 11 family-based and 2 group-based sessions          consisting of behavioral techniques and educational content about eating nutrient-dense,          low GI foods. CGM results will give families feedback about how their diet affects blood          glucose levels. At least one parent and the child with T1D will participate in the          intervention.        -  Intervention topics will consist of goal setting, behavior self-monitoring, educational          information, and problem solving, among others. Parents and children will record the          foods they eat.        -  Control group families will participate in 11 family-based sessions consisting of CGM          feedback.        -  Assessments will be conducted at 6, 12, and 18 months, and medical record information,          including blood and urine testing, will be obtained at each routine clinic visit.   "
239891|NCT00999388|"     Background:        -  Parkinson disease (PD) is the second most prevalent neurodegenerative disease, affecting          more than 1 percent of the elderly population in the United States and other Western          countries. Although effective treatments can alleviate symptoms in early PD, no cure or          treatment slowing disease progression has been identified, and patients will eventually          develop severe physical and mental disabilities and often die of complications. More          research is needed on the causes of and appropriate preventive strategies for PD.        -  The Shanghai Women s Health Study (SWHS) was established 10 years ago by investigators          from the Vanderbilt University, the Shanghai Cancer Institute (SCI) and the National          Cancer Institute (NCI) of the US. Their primary aim was to examine several unique          dietary hypotheses on cancer among Chinese women. Researchers from the National          Institute of Environmental Health Sciences and SWHS investigators are now interested in          studying PD patients from SWHS to evaluate biological and environmental factors that may          have put them at risk for PD.      Objectives:        -  To initiate a long-term prospective study on PD in Chinese women from the Shanghai Women          s Health Study.        -  To examine a set of biological and environmental factors that may raise or lower risk of          developing PD.      Eligibility:      - All participants of the SWHS cohort are eligible.      Design:        -  Researchers will contact self-reported PD cases from the SWHS, confirm (or reject) the          self-report, and invite them to a clinical examination at a coordinating hospital in          Shanghai.        -  Cases that confirm the self-report will be invited to visit the coordinating hospital          for clinical examinations, including a PD clinical workup, blood and urine collections,          a cognitive assessment and relevant neuropsychological testing, and an interview on          additional risk factor exposures that are not available from baseline surveys.        -  For those who could not participate in the clinical examination, researchers will ask          for a few details about the diagnosis and treatment history and ask for permission to          obtain medical records relevant to PD diagnosis from government or hospital agencies.        -  For self-reported PD cases who are now deceased, researchers will follow a similar          procedure by asking for consent and help from the next-of-kin.   "
239892|NCT00999401|"     The primary objective of this study is to determine the maximum tolerated dose (MTD) or     recommended phase II doses of sapacitabine and seliciclib administered sequentially or     concomitantly. The secondary objectives are to evaluate antitumor activity of this sequential     or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin     and peripheral blood mononuclear cells.   "
239893|NCT00999414|"     This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib     to patients with relapsed or resistant refractory multiple myeloma.   "
239894|NCT00999427|"     During a prostate biopsy, a needle is guided through the rectum into the prostate. Although     patients are given antibiotics before the biopsy, there is still a risk of bacteria getting     from the rectum into the bladder, prostate and bloodstream during the biopsy. For most     surgical procedures, the surgical field is cleaned with antiseptic solution, but this is not     common practice for prostate biopsies. In this study patients undergoing prostate biopsy will     be randomly assigned to either receive an antiseptic preparation of the rectum or no     preparation prior to biopsy, and the rate of infection after the biopsy will be determined.   "
239906|NCT00999583|"     The investigators hypothesised that the neuroprotective effects of erythropoietin and its     analogues could lead to an improve outcome after cardiac arrest. To test this hypotheses, the     investigators designed a randomized, multicentre, simple blind trial in which all     participating patients will be receive usual treatments and 50% of them will also receive a     high dose of epoetin alpha (an analogue of erythropoietin) in an add on fashion. The main     end point will be the proportion of patients in each arm who will reach at day 60 the best     level of recovery, using a 5 level score.   "
239907|NCT00999596|"     The purpose of this investigation, using hardcopy film, is to compare the accuracy of the     Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of     breast cancer among women undergoing screening or diagnostic mammography.      Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no     longer required.   "
239909|NCT00999622|"     RATIONALE: Gathering information over time from laboratory tests of patients with newly     diagnosed malignant supratentorial astrocytoma may help doctors learn more about the effect     of treatment on white blood cell count and the risk of infection.      PURPOSE: This clinical trial is studying blood samples and risk of infection in patients with     newly diagnosed malignant supratentorial astrocytoma.   "
240380|NCT01002937|"     The purpose of this project is to analyze tumour tissue from a group of subjects with renal     cell carcinoma, who have been treated at the Royal Marsden Hospital.   "
239895|NCT00999440|"     QTc:      Since the reports of three deaths attributed to Torsade de Point (TdP) related to treatment     with the long-acting methadone derivative levomethadyl acetate HCl (LAAM), methadone has been     scrutinized for any possible association with TdP. Since then, several studies among     Methadone Maintenance Treatment (MMT) patients and chronic pain patients were done, reporting     diverse results about possible association between methadone dose and QTc prolongation. Most     studies however were cross-sectional and generally found insignificant clinical prolongation     of QTc. A follow up studies are of importance, and although few studies have started     evaluating QTc among MMT patients, none was done among chronic pain patients with no history     of drug usage. One study of 8 chronic pain patients experiencing insufficient pain control or     intolerable side effects during treatment with oral morphine switched to oral methadone     showed insignificant modest increase QTc following 9 month.      Perceived Sleep:      Chronic pain patients as well as drug addicts are known to suffer from poor sleep. Some     studies found possible relation to methadone dose, however, no causal association was found     and importantly some also found association with duration of opiate usage before starting     methadone when entry to MMT clinic. Thus, patients with no history of opiate addiction are an     important interesting group that may help understand relation between methadone usage and     sleep quality. However, sleep must be evaluate before opiate administration and a follow up     study is needed   "
239896|NCT00999453|"     Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in dialysis     patients. Although significant improvements have been made in the management of CVD in the     general population, it is not known whether these interventions would result in similar     benefits in end stage renal disease patients.      Clinical studies conducted in the general population and in patients with established     cardiovascular disease have found a strong independent association between lipid lowering,     primarily LDL-cholesterol, and the risk of all-cause and cardiovascular mortality.      Therefore the National Cholesterol Education Panel (NCEP) has provided guidelines to lower     LDL cholesterol levels to a goal of ≤100 mg/dl in patients with major risk factors of     coronary heart disease. Moreover, the recent Adult Treatment Panel III (ATP III) guidelines     provide an option to lower LDL cholesterol levels to a goal of <70 mg/dl in patients with     very high risks for coronary heart disease.      The National Kidney Foundation K/DOQI guideline regards dialysis patients as having high     risks for coronary heart disease and consequently recommends the LDL cholesterol level to be     maintained under 100 mg/dl. This recommendation is in parallel to the NCEP ATP III guideline     which has been proposed for the general population. However, data regarding cholesterol     levels in dialysis patients have been conflicting, with some observational studies     demonstrating and some not demonstrating a clear, relationship between LDL and cardiovascular     end-points. In addition few randomized studies have been conducted in CKD patients.      An observational retrospective analysis of patients receiving hemodialysis, the U.S. Renal     Data System Morbidity and Mortality Study, showed that the risk for cardiovascular mortality     was decreased by 36 percent among patients receiving statins, compared to those who did not.     Whereas, a most recent large prospective study in diabetic hemodialysis patients failed to     demonstrate a significant reduction in cardiovascular endpoints with statin therapy.      Moreover, although HD and PD patients both develop chronic hypervolemia and inflammation as     common findings, the relationship between risk factors and outcome may differ between these     two treatment methods. The likely role of glucose from the dialysate in causing dyslipidemia     in PD patients inherits a different strength of association between cholesterol level and     outcome in HD and PD patients.      Therefore, this study aims to examine the clinical outcomes of treating chronic peritoneal     dialysis patients with dyslipidemia to lower cholesterol levels, randomly assigning patients     to either aggressive targets of LDL cholesterol of 70 mg/dl or current standard targets of     LDLD cholesterol of 100 mg/dl.   "
239897|NCT00999466|"     AZD8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis     (hayfever). This study will be in two parts and will include 59 asthmatic patients in total.     The first part will investigate the tolerability and safety of AZD8848 while the second part     will investigate both the therapeutic effect of AZD8848 and how well patients tolerate the     drug.   "
239898|NCT00999479|"     The aim of this study is to determine whether or not continuous combined oral contraceptive     pills (COCP's) decrease the risk of recurrent endometrioma formation. The investigators'     hypothesis is that patients who have endometriomas surgically removed and then are started on     COCP's will have a decreased incidence of recurrent endometrioma formation. The     investigators' research protocol is designed to show a statistically significant decreased     incidence of endometrioma formation in the hopes that physicians will use COCP's in patients     they have removed an endometrioma in who do not desire immediate fertility. Long term, the     investigators hope to establish a standard of care that COCP's be used postoperatively in     appropriate candidates to decrease the chance of recurrent endometrioma formation.   "
239899|NCT00999492|"     Given the availability of aspheric diffractive IOLs with varying negative spherical     aberration it may be feasible, by selecting the best fit IOL, to minimize aberrations and     thereby maximize visual performance.   "
239900|NCT00999505|"     Amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative     and cognitive symptoms.   "
239901|NCT00999518|"     In a previous study in patients with interstitial cystitis/ painful bladder syndrome     (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS,     as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab     was well tolerated. In this study, the hypothesis being tested is that tanezumab will show     efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety     will also be assessed at different dose levels   "
239902|NCT00999531|"     The purpose of this study is to evaluate the safety and tolerability of repeated doses of     GS-9411 in healthy volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway     hydration and mucociliary clearance in the lung.   "
239903|NCT00999544|"     Addressing the issue of opioid dependence and tolerance has public health implications for     the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the     treatment of pain. Recent preclinical data suggest a role for Substance P (NK-1) receptors in     modulating both the acute and chronic response to opioids. The objective of this study is to     determine whether pretreatment with aprepitant, a selective neurokinin-1 (NK-1) antagonist     can reduce the direct response to an opioid agonist (oxycodone) on measures related to abuse     liability and reinforcing effects.   "
239904|NCT00999557|"     RATIONALE: Bimatoprost ophthalmic solution may help increase eyebrow and eyelash growth in     patients who have undergone chemotherapy.      PURPOSE: This randomized clinical trial is studying how wells bimatoprost ophthalmic solution     works in increasing eyebrow and eyelash growth in patients who have undergone chemotherapy     for breast cancer and in healthy participants.   "
239905|NCT00999570|"     To determine whether specialty training or high volume of operative experience is associated     with better clinical outcome and quality-of-life scores.   "
239908|NCT00999609|"     The study is a Phase 3, open-label, randomized controlled trial of gene therapy intervention     by subretinal administration of AAV2-hRPE65v2. At least twenty-four subjects, three years of     age or older, will be recruited. The intervention group will receive AAV2-hRPE65v2 vector at     either The Children's Hospital of Philadelphia or University of Iowa to determine if it     improves visual and retinal function in individuals with LCA2.   "
239910|NCT00999635|"     Importance of the topic:      Lower extremity amputation is a costly complication of diabetes for both the NHS and the     patient. Amputation may be avoided if the preceding foot ulceration can be prevented. One     method of reducing the risk of ulceration in the neuropathic foot is through the provision of     therapeutic insoles. The type of insole prescribed (prefabricated verses custom made) is     currently based on anecdotal evidence. The idea held by many practitioners that the custom     made insole is superior in its effect remains speculation, unsupported by the evidence. In     the absence of economic analysis, the available data suggests that the custom insole is     substantially more expensive to the NHS. This study, to determine which of two types of     insole used in therapeutic shoes reduces peak pressure more in the at−risk diabetic foot, is     therefore a very important topic and will provide both useful evidence for the NHS podiatry     services. It is of course also very important for patients with diabetes as the personal     suffering of those undergoing amputation is immense.      The study is a single blind randomised controlled trial comparing custom made with 'off the     shelf' insoles.   "
239911|NCT00999648|"     The objective of this study is to evaluate the efficacy of myofascial trigger (MTP) point     deactivation for tinnitus control in a population with tinnitus and myofascial pain.   "
239912|NCT00999661|"     The purpose of this study is to evaluate the results patients are obtaining with the Realize™     Adjustable Gastric Band-C during the first 24 months after surgery.   "
239913|NCT00999674|"     The present study aimed to investigate the effect of exercise program on health-quality of     life (HQL) in older adults.   "
239914|NCT00999687|"     The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract     in treating nail psoriasis.   "
239915|NCT00999700|"     A phase III trial of induction chemotherapy followed by definitive radiotherapy plus     Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of     the head and neck (HNC).   "
239916|NCT00999713|"     Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia     and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these     children represent a relatively small and unique patient population, they account for the     largest proportion of deaths of all pediatric diseases. The long-term goal of this project is     to improve outcomes among these patients. Recently, the intratracheal administration of     calfactant has resulted in decreased mortality among children with ALI including promising     results among children with cancer and following HSCT. Consequently, the primary specific aim     of this study is to assess the effect of calfactant on intensive care (PICU) survival among     pediatric leukemia and lymphoma and HSCT patients with ALI. Secondary aims include assessment     of the effect of calfactant on oxygenation and on the length of mechanical ventilation, PICU     stay, and hospital stay. Calfactant therapy has been found to be of benefit in acute lung     injury in the overall pediatric population by improving oxygenation and decreasing mortality.     These findings, in conjunction with recent subgroup analysis in which calfactant therapy     appeared to improve outcomes in immunocompromised children provide the rationale for     assessing calfactant therapy in this patient population.      Funding Source - FDA OOPD   "
239917|NCT00999739|"     Randomised study comparing two pneumococcal vaccination strategies in HIV-infected adults     with moderate immunossupression (CD4 between 200 and 500 cells/uL and viral load under     5logs), one with conjugated heptavalent vaccine(Prevenar, Wyeth-Lederle) followed by     polysaccharide vaccine 4 weeks after (Aventis-Pasteur), and two with one dose of     polysaccharide vaccine. Determination of secondary effects related to both vaccines and     determination of antibody concentration (ELISA) and avidity (ELISA with thiocyanate) and     opsonophagocytosis killing activity against the seven serotypes included in the heptavalent     vaccine before vaccination, at 4 weeks, at 8 weeks, at48 weeks and 96 weeks. A sample of 220     HIV-infected adults (110 in each group) will be needed to detect differences of 10% for a     type I error o 5% for a limited population of 2500 HIV-infected adults. The main hypothesis     are :the immunogenicity of pneumococcal vaccination with conjugate and polysaccharide     vaccines is superior to immunogenicity induced by polysaccharide vaccination alone(antibody     concentration), the avidity and opsonophagocytosis induced by two vaccines is better than the     one after polysaccharide vaccine alone, both vaccinations are safe.   "
239918|NCT00999752|"     The main purpose of this study is to evaluate the effects of Nebivolol and     Hydrochlorothiazide on blood pressure in African Americans with high blood pressure.   "
239919|NCT00999765|"     The purpose of this study is to evaluate the feasibility and short-term efficacy of MBCT as     an add-on (i.e. patients must be stable with their regular mood stabilizing medication) for     the maintenance therapy of bipolar disorder.   "
239920|NCT00999778|"     This project will examine the efficacy of two different treatment approaches aimed at     facilitating change in social and communications outcomes of toddlers with autism.   "
239921|NCT00999791|"     Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.      Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe     dosage is identified that can be used in diffuse diabetic macular edema for treatment. in     this study, we are going to compare the effect of intra vitreal injection of Diclofenac and     Bevacizumab in primary treatment of diffuse diabetic macular edema.   "
239935|NCT00989027|"     The purpose of this study is to compare the ability of a sample of uterine muscle tissue to     contract in the presence of various drugs. The drugs studied are typically used to contract     the uterus when a pregnant patient continues to bleed after delivery. Amongst the uterotonic     drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost, the most     effective one to use is not known.      The investigators will be testing uterine muscle samples in the presence of these drugs at     various concentrations, to see what their contractility measures over time, as compared with     a control sample, in which no drugs will be applied.   "
239936|NCT00989040|"     Pain is defined as a sensorial and emotional phenomenon and lead consequences on the     cognition. These consequences could be increased with usual treatment. So the aim of this     study is to explore these cognitive consequences.   "
240000|NCT00989872|"     This was a randomized, double-blind, placebo-controlled, ascending single dose safety,     tolerability, and pharmacokinetic study of orally administered EDP-322. This study was     conducted at a single site. EDP-322 has a benefit to risk profile that supports testing in     target patient populations.   "
239922|NCT00999804|"     Breast cancer is the most common malignancy in the U.S. Targeted therapies such as tamoxifen     have been revolutionary in reducing tumor recurrences and mortality in early breast cancer.     Using this successful paradigm, there has been a continued search for other targeted biologic     therapies directed at receptors with known potential for promoting tumor growth.      The estrogen receptor (ER) and/or the HER signaling pathways are the dominant drivers of cell     proliferation and survival in the majority of human breast cancers. Molecular targets of     these pathways provide the most effective therapies in appropriately selected patients.     However, de novo and acquired resistance remain major obstacles to successful treatment, and     understanding the molecular pathways responsible for this resistance would enable the     discovery of new strategies to overcome it.      The superiority of multi-drug HER2-targeted therapy over single agent therapy has been     demonstrated in the preclinical setting using mouse xenografts. Trastuzumab, pertuzumab,     lapatinib, and gefitinib, represent a group of therapeutic agents that target the HER family     by different molecular mechanisms. Used as single agents in the MCF7/HER2-18 xenograft model,     these drugs restored or enhanced sensitivity to tamoxifen. However, tumor growth inhibition     lasted only 2-3 months before resistance to treatments occurred. However, when gefitinib, a     HER1 inhibitor, was added to the two-antibody (T+P) regimen to block signals from HER1     dimers, a complete disappearance of nearly all xenograft tumors was observed; moreover, there     was evidence of complete tumor eradication in 50% of the mice. The combination of lapatinib +     trastuzumab was also highly effective in eradication of tumor burden, with no evidence of     re-growth after 200 days. These xenograft models demonstrate that multi-drug HER2-targeted     therapy more effectively induces apoptosis and inhibits proliferation, thereby resulting in     tumor regression. Furthermore, HER2 combination therapy appears to more effectively reduce     levels of phosphorylated pAKT and MAPK, thus resulting in sustained tumor inhibition.   "
239923|NCT00999817|"     A study to study the potential effect of PF-00299804 inhibition of CYP2D6 on     dextromethorphan.   "
239924|NCT00999830|"     This is an open randomised phase II study evaluating the anti-tumour activity, safety and     pharmacology of two dose regimens of IPH2101, a human monoclonal anti-KIR antibody, in     patients with multiple myeloma in stable partial response after a first line therapy.   "
239925|NCT00999843|"     Patients with liver cancer will receive interventional therapy plus radiotherapy. Maintenance     Sorafenib will be taken after the completion of radiotherapy. Hypothesis of the current study     is that Sorafenib as a maintenance therapy is safe and superior to radiotherapy combined with     interventional therapy in terms of survival in comparison to historical data.   "
239926|NCT00999856|"     The study is intended to evaluate a non-invasive method of glucose measurement in diabetics.     The medical device that is evaluated consists on a sensor-insert which is placed under the     conjunctiva of the eye of diabetic patients and a photometer. The goal is to prove that the     sensor signal correlates with the blood glucose of the patients determined by standard     laboratory blood glucose measurement.   "
239927|NCT00999869|"     Alopecia areata is one of the most common cause of non-scarring alopecia. The pathogenesis is     still unclear, however, it is believed to be an autoimmune disease. This disease is not a     life-threatening condition but it has a significant psychological impact to patient's quality     of life.      Many triggers have been proposed such as viral infection, stress and neurologic factors.     There are many studies show the correlation between disease activities and neurotransmitters     level. Substance P and calcitonin gene-related peptide play major role in early stage of     disease. These substances cause imbalance of CD4/CD8 lymphocyte in pathologic site and loss     of immune privilege of hair follicles.      The conventional treatment of alopecia areata with intralesional corticosteroid injection     might treat the end of pathogenesis process.      There is no therapeutic intervention for the origin of disease. Fortunately, botulinum toxin     A could be a novel treatment of alopecia areata. The botulinum toxin A demonstrates     inhibition release of substance P in many publications.      To sum up, the treatment of alopecia areata with intralesional corticosteroid injection still     be a standard treatment, nevertheless, patients have to receive this treatment every month     until regrowth of scalp hair. Corticosteroid injection have several side effects, for     example, skin atrophy, pigmentary change and hypothalamic-pituitary-adrenal axis suppression.     Moreover, injection pain is also affect to psychological aspect .      This study purpose is to evaluate the efficacy of botulinum toxin A for alopecia areata and     reduce corticosteroid side effects, as well as, others opportunity cost. There is no     prospective, randomized-controlled trial of comparison study between botulinum toxin A     injection and corticosteroid injection for alopecia areata, therefore, investigators conduct     this study for the greatest benefit to alopecia areata patients and for the future research     in disease etiology.   "
239928|NCT00999882|"     The main purpose of the study is to establish a safe dose of AZD8055 in patients with mild or     moderate liver disease by providing information on any potential side effects this drug may     cause and collecting data about how hepatocellular carcinoma responds to the drug.   "
239929|NCT00999895|"     The purpose of the study is to evaluate the outcome of treatment switch defined as an     improvement in CGI-CB scale (Clinical Global Impression - Clinical Benefit).   "
239930|NCT00988962|"     Chronic back pain patients are often dismissed from a pain center or a primary care practice     when they are noncompliant with opioid therapy, instead of being offered treatments to reduce     misuse and to improve compliance. Unfortunately, there are few treatment resources for such     patients. This study seeks to remedy that problem, with the goal of reducing the rate of     prescription opioid misuse among noncompliant patients through the use of novel tracking,     education, and counseling interventions.   "
239931|NCT00988975|"     Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health     are eligible to enroll in this study. Two different methods of correcting rectocele at the     time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and     patient satisfaction with intercourse and bowel function. One of the surgical methods uses an     additional graft material and one surgical method does not. It is hypothesized that the     method which uses an additional graft material to strengthen the patient's tissues will have     a better outcome.   "
239932|NCT00988988|"     Participants are asked to be in this study because they have multiple sclerosis, are     currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain,     swelling, itching or a lump at the injection site.      The purpose of this study is to determine if the use of ethyl-a-guanida-methyl ethanoate     (AGEE) will decrease histamine response measured by redness, swelling, and itch response     following subcutaneous injection of glatiramer acetate (GA) for the treatment of Multiple     Sclerosis (MS).   "
239933|NCT00989001|"     The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in     subjects with recent onset (AF > 3 hours to <= 7 days), symptomatic atrial fibrillation and     no evidence or history of congestive heart failure.   "
239934|NCT00989014|"     This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to     investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel     (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis     of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in     a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%,     0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once     daily dosing for one day) of study medication.   "
239963|NCT00989391|"     The purpose of this study in heathy people is to investigate the safety, toleration and time     course of PF-03654764 in the blood, following multiple doses given once or twice daily by     mouth for 10 days.   "
239937|NCT00989053|"     Women undergoing IVF show a high prevalence of depressive and anxiety symptoms. Furthermore,     stress has harmful consequences on IVF and pregnancy outcomes. An immunological cascade was     suggested to be involved in the process. Treatment in this setting is usually psychotherapy     rather than pharmacotherapy, despite reasonable biological evidence suggesting beneficial     influence of antidepressant therapy on pregnancy and well-being. Moreover, pharmacotherapy is     more available and affordable than psychotherapy in the public health system. The     investigators suggest to study the efficacy of antidepressant treatment in women undergoing     IVF treatment, presenting with mild mood symptoms. The investigators hypothesize that     treatment will result in a greater attenuation of affective symptoms, as well as in higher     pregnancy success rates. Furthermore, certain immunological stress-reactive factors, may     prove to be the biological mechanism underlying these effects.   "
239938|NCT00989066|"     To evaluate the performance and long-term clinical outcomes of the Xience V     everolimus-eluting coronary stent system (EECSS) in the treatment of minimally selective,     high risk patients in the real-world clinical practice.   "
239939|NCT00989079|"     Ertugliflozin (PF-04971729, MK-8835) is a new compound proposed for the treatment of Type 2     diabetes mellitus. The primary purpose of this study is to evaluate the safety and     tolerability along with the pharmacokinetics of single escalating doses of ertugliflozin     under fed and fasted conditions in healthy volunteers.   "
239940|NCT00989092|"     This phase 2, multicenter, randomized, open-label, comparative study was designed to     determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health     related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not     receiving chemotherapy. Participants were randomly assigned in a 4:1 allocation ratio to     receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of     observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).   "
239941|NCT00989105|"     RATIONALE: Diagnostic procedures, such as technetium Tc 99m demobesin-4 followed by     single-photon emission computer tomography, CT scan, and MRI, may help find prostate cancer     and learn the extent of disease.      PURPOSE: This phase I trial is studying the side effects of technetium Tc 99m demobesin-4 and     to see how well it works for imaging procedures in patients with prostate cancer.   "
239942|NCT00989118|"     This is a randomised study comparing the effect of two laparoscopic techniques for treatment     of ovarian endometriomas on recurrence rate and ovarian reserve.   "
239943|NCT00989131|"     RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has     a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor     EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical®     does not contain Cremophor EL, hypersensitivity reactions can be expected to be less.      PURPOSE: To study the efficay and safety of two different formulations of paclitaxel,     Paclical® and Taxol®.   "
239944|NCT00989144|"     The study of early, acute HIV infection is critical to understanding subtype-specific     pathophysiologic differences, since up to 50% of acute HIV infections may be incapacitating.     This study will establish whether the patient population of the Thai Red Cross Anonymous     Clinic is suitable for the study of early, acute infection.   "
239945|NCT00989157|"     This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine     between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control     subjects matched for body mass index (BMI), age and gender.   "
239946|NCT00989170|"     The long-term goal of this project is to develop, evaluate, and disseminate to Extension     Service families across the state of Colorado, an engaging, interactive, and evidence-based     Family Program in order to prevent weight gain in adults and excess weight gain in children.     Excess weight gain in children is defined as an increase in body weight beyond the increase     in weight associated with normal growth and development. The program will focus on small,     easily adopted, sustainable, lifestyle changes.      Project Objectives include:        1. Enhancing a Family Program by including food and physical activity environmental          assessments, an online social network, and a pre-programmed health-based text messaging          system, and by gaining feedback from extension families through a series of 6 focus          groups.        2. Conducting a randomized trial to evaluate the impact of the enhanced Family Program on          the prevention of weight gain in families with overweight children. The investigators          hypothesize that excess weight gain will be prevented in subjects in the intervention          group, while those in the control group will gain excess weight.        3. Disseminating the Family Program through USDA Cooperative Extension Services in Colorado          and evaluate the usefulness/effectiveness of the program for USDA Extension agents and          participating families. The investigators will conduct 4 additional focus groups at the          end of this objective to gain feedback on its usefulness in a real-life setting. This          objective is different from objective 2 in that the investigators are evaluating the          program in a real-life setting, using qualitative and self-reported data, rather than          conducting a clinical trial.      By conducting focus groups with Extension families during both objectives #1 and 3, the     Family Program will help to improve knowledge regarding behavioral and environmental factors     influencing obesity. After enhancing the Family Program (Objective #1), the investigators     will test its effectiveness in a randomized study of 200 families (Objective #2). Finally,     after having developed and tested this effective intervention strategy, the investigators     will disseminate it through Extension Agents throughout the state to evaluate its usefulness     in a real-life setting (Objective #3).   "
239947|NCT00989183|"     The goals of this research proposal are to further our understanding of the reproductive     aging process in women and to improve our ability to clinically assess and model reproductive     aging. Reproductive aging is a continuous process that begins many years prior to menopause.     Women in their late 30s and early 40s usually maintain normal menstrual function and     ovulatory status, yet fertility in these women is considerably compromised compared to     younger women. The primary mechanism of reproductive aging is through the process of ovarian     primordial follicle (egg) depletion, a process that exhibits considerable variation between     women. As a result, the age at which an individual begins to experience infertility and     menstrual cycle changes secondary to follicle depletion also varies significantly and is     difficult to predict. Multiple studies have investigated the impact of lifestyle choices     (tobacco use, oral contraceptives, BMI, alcohol use, and parity) on reproductive lifespan by     correlating the impact of these exposures with the age of spontaneous menopause. Although     occasionally in agreement, many of these studies report contradictory findings. Alcohol use     either delays or has no effect upon the age of spontaneous menopause. Similarly, oral     contraceptive pill use has been suggested to both accelerate and delay the onset of     menopause. The most consistent findings regarding the impact of these factors is an     acceleration in the age of menopause by 1-2 years in smokers. Given the lack of consistent     findings in these investigations, the exact impact of lifestyle factors on reproductive age     is currently unknown. Nevertheless, the magnitude of such exposures in the U.S. population is     considerable, with 19% of adult women using oral contraceptives and 19.2% current smokers     according to recent statistics. This proposal seeks to develop better models of normal female     reproductive aging through anatomical studies investigating the impact of lifestyle choices     on ovarian primordial follicle number. A secondary aim is to determine the relationship     between newly described markers developed to assess biological aging in other organ systems     (white blood cell telomere length and the measurement of advanced glycation end products     (AGEs) through skin autofluorescence) and reproductive age.   "
239948|NCT00989196|"     This is a clinical study to investigate the pharmacokinetics, efficacy, safety and     immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant     FVIII concentrate in previously treated patients with severe Hemophilia A.   "
239949|NCT00989209|"     Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin     injection in patients with long standing facial unilateral palsy.   "
239950|NCT00989222|"     Promising results have been reported after volar locked plating of unstable dorsally     displaced fractures of the distal radius. It offers stable fixation and early mobilization.     The investigators' aim is to test if volar locked plating results in better     patient-perceived, objective functional and radiological outcomes compared to the less     invasive external fixation that has been the standard operation for decades.   "
239951|NCT00989235|"     The purpose of this exploratory sub-study was to evaluate from a clinical perspective the     impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in     subjects who had achieved remission (Disease Activity Score 28 [DAS 28]-erythrocyte     sedimentation rate [ESR] < 2.6) at Day 701 of study IM101023.   "
239952|NCT00989248|"     At the neck level immersion, the water pressure causes significant displacement of blood from     the lower limbs to the Intrathoracic circulation, triggering adaptive physiological responses     due to the increase in central blood volume and consequent cardiovascular burdens. Immersion     in warm water breaks the homeostasis, stimulates regulation mechanisms and responses of     organs and systems beneficial to healthy and heart failure individuals. In literature there     are a growing number of studies demonstrating the efficacy of exercises performed in the     water.   "
239953|NCT00989261|"     AC220 will be administered as a once daily oral solution given continuously as 28-day     treatment cycles, without any rest periods, until disease progression, relapse, intolerance     to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).   "
239954|NCT00989274|"     In agreement with the World Organization of the Health (WHO), during the annual epidemics of     influenza they become infected between 10-20 % of the total population, appearing from a     feverish disease up to leading to the hospitalization and in some cases to the death. To     unpredictable intervals and due to the nature of the virus, this one can acquire new genes of     others virus of the influenza that they concern birds or porks, of it it turns out to be a     new virus with a completely new subtype of IT (HE,SHE) HAS and NA, and if this one is     transmitted efficiently of person-to-person can cause a pandemic.      This phenomenon has been the one that has given place to the appearance of a new causative     virus of the outbreak of influenza humanizes in Mexico (A/México/2009 (H1N1)), and in     agreement to official Mexican numbers(figures), until August 13 there have been     brought(reported) a whole of 18,861 cases and 163 deaths. The measure of the most effective     control against the influenza constitutes it the vaccine, by what study becomes imperative to     possess (to rely on) a vaccine against the new virus To (H1N1) East is relevant, due to the     level of response of alert to a level 6 (pandemic) that has passed the World Organization of     the Health (WHO).   "
239955|NCT00989287|"     The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'     investigational vaccine GSK2340272A in adults aged 18 to 60 years.   "
239956|NCT00989300|"     The purpose of this study is to assess, whether the administration of a proton pump     inhibitor, Rabeprazole, has a negative effect on the activity of a concomitantly administered     blood thinner drug. Proton pump inhibitors (PPI's) are prescribed for patients with gastric     problems to reduce the gastric acid secretion. The blood thinner drug, Clopidogrel,     administered in this trial is approved for the treatment of mild heart attacks; it works by     preventing blood platelets from sticking together to form clots that would restrict blood     flow. Previous trials have shown that the proton pump inhibitor omeprazole interacts with the     blood thinning drug clopidogrel to reduce the active form of clopidogrel, thereby preventing     the drug's blood thinning effect. In this trial, the effect of two different proton pump     inhibitors, namely rabeprazole and omeprazole on the activity of the blood thinner drug     clopidogrel will be assessed and compared to the effect of placebo on the activity of the     blood thinner drug clopidogrel. This will be done in three sequential periods and each of the     patients enrolled into this trial will be asked to participate in three different periods,     during which clopidogrel with either rabeprazol, or omeprazol, or placebo will be     administered daily.   "
239957|NCT00989313|"     This study is designed to follow up patients, who have participated in the PEP005-028 study     and observed complete clearance of their Actinic Keratosis (AK) lesions, over a 12 month     period to assess both recurrence of AK lesions and long term safety in the selected treatment     area.   "
239958|NCT00989326|"     The study investigates whether home monitoring follow-up of Pace-Maker patients is as     efficient as conventional method in terms of Significant Serious Adverse Event (SSAE).   "
239959|NCT00989339|"     Recent evidence suggests that increased levels of a circulation fat (free fatty acids or     FFAs) can cause high blood pressure and cardiac complications. Intralipid is the only type of     fat approved by the FDA for clinical use. It is usually used as nutrition support in     malnourished patients. The investigators' preliminary studies indicate that Intralipid     results in a significant rise in blood pressure, blood vessel stiffness, and inflammation in     obese subjects. Olive oil can also be used as nutrition support. The effect of olive oil     intravenous (IV) on blood pressure and inflammation is not known. In this study, the     investigators will compare the effect of Intralipid and olive oil on blood pressure, blood     vessel stiffness and inflammation in healthy subjects. The investigators hypothesize that     Olive oil emulsions will result in less vascular changes and less inflammatory response than     Intralipid solutions. Accordingly, the investigators propose a systematic evaluation of the     effects of Intralipid, olive oil and normal saline on blood pressure, endothelial function     (vascular stiffness), inflammation in normal subjects.      A group of obese subjects will be admitted to the Clinical Research Center on 3 occasions.     Subjects will receive repeated infusions of Intralipid, ClinOleic, and normal saline at 20     ml/hour for 24 hours.   "
239960|NCT00989352|"     The purpose of this study is to determine whether combined chemotherapy [rituximab plus high     dosage methotrexate, lomustine, and procarbazine] followed by maintenance therapy with     procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL] in     patients > 65 years.   "
239961|NCT00989365|"     The investigators hypothesize that aerobic training can reduce anxiety, depression and airway     inflammation and those benefits may be related to changes in autonomic system.   "
239962|NCT00989378|"     This study will examine the relationship between the amount of slow wave sleep (deep sleep)     and the ability of the body to bring the blood sugar level to a normal range after receiving     glucose.   "
240662|NCT01005511|"     To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms     and at the jaw muscle activity during sleep.   "
239965|NCT00989417|"     In many aspects of every-day life, modern communication systems bring about a remarkable     increase in comfort and safety by transmitting data and information in an easy and reliable     manner. In order to provide these advantages also to patients with implantable     cardioverter-defibrillators, as well as to their physicians, BIOTRONIK has developed a     long-distance implant telemetry to enable periodic trend and event-triggered transmissions of     implant data and intracardiac electrogram over distances of several meters. The data is     received by a patient device and subsequently automatically transferred to a BIOTRONIK     Service Center that provides it to the physician on a password secured internet site. Hence,     the physician receives diagnostic information without the patient having to visit the     physician (Home Monitoring, HM). New possibilities will arise for a detailed medical and     event-correlated supervision of the patient's therapy using electrically active implants.   "
239966|NCT00989430|"     The purpose of this research study with a randomized controlled design is to examine the     effects of prism adaptation treatment on two visual-spatial recovery components. After a     stroke, an internal GPS, locating where objects or people lie in a particular area of     space, may be impaired. Alternately, a stroke may impair precise visual-spatial hand and body     aiming movements. The research team wishes to discover whether prism adaptation treatment     (two weeks of daily 20-min sessions of goal-directed movement with prism goggles) affects     visual-spatial where or aiming errors selectively after stroke.      This research represents one of the first attempts to apply what we know about the brain from     neuroscience research, to modern clinical rehabilitation practices.   "
239967|NCT00989443|"     Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of     cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the     standard treatment is the conisation of cervix (surgical act). A local treatment with the     antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and     reduce obstetrical morbidity induced by the conisation.      This clinical study is aimed at :        1. evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix          exhibiting high grade CIN lesions;        2. evaluating the pharmacokinetic (PK) profile of cidofovir after local application.   "
239968|NCT00989456|"     This study addresses self management and maintenance of health through evaluation of a     program of patient education in combination with physical training and with a structured     follow-up.      It is hypothesized that such a program will:        1. improve quality of life, physical functioning, coping in everyday-life        2. reduce hospitalization and (re-)admissions for patients with chronic disease, reduce          consumption of home care services and can increase consumption of general practice and          physiotherapy services in primary health care.        3. improve patient satisfaction and health care providers satisfaction   "
239969|NCT00989469|"     A multicentre two-part phase I/II study evaluating response and safety of SORAFENIB in     combination with irinotecan in the second line treatment or more of metastatic colorectal     cancer with K-RAS mutation.   "
239970|NCT00989482|"     The purpose of this study is to improve antibiotic prescribing practices of Mexican primary     care physicians for patients seeking care for acute respiratory tract infections (ARIs). The     investigators will employ a combination of qualitative and quantitative methods to develop     and evaluate a patient education and physician decision-support intervention.      Hypothesis 1: The investigators will identify barriers and facilitators of appropriate     antibiotic use for ARIs that can be addressed through patient education and physician     decision-support.      Hypothesis 2: The proportion of patients who report desire for antibiotics as a very     important reason for seeking care will decrease from 50% to 30% following exposure to the     educational intervention; and 90% (95% confidence interval: 80% to 100%) of patients will     report that they trust the information provided by the computer.      Hypothesis 3: Antibiotic prescribing for adults with uncomplicated acute bronchitis will     decrease from 80 percent to 40 percent following the introduction of a real-time clinical     decision support tool.   "
239971|NCT00989495|"     The purpose of this study is to gain initial experience and information for proper planning     and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study     of bracing).   "
239972|NCT00989508|"     Open-heart surgery causes injury of the heart muscle. Although this is usually mild,     temporary and reversible, if it is severe it can endanger life and require additional high     cost care. During surgery, techniques are used to protect the heart from injury, but these     remain imperfect. Patients with a thickened wall of the heart (left ventricular hypertrophy)     may be at greater risk. This study assesses the effect of facilitating sugar metabolism (a     more efficient fuel) by the heart muscle using the drug Perhexiline given before the     operation.      This treatment has a sound experimental basis for improving outcome. If this improvement is     confirmed surgical results could be improved. The investigators will be studying heart     function, heart muscle energy stores and chemicals which quantify the amount of heart muscle     injury. The investigators' hypothesis is that Perhexiline will improve the protection of the     heart by decreasing damage that may occur during heart surgery.   "
239973|NCT00989521|"     PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma.      Study objectives are to :        1. to evaluate the safety of PUR003 in subjects with asthma, and        2. to evaluate the efficacy of PUR003 in assisting the treatment of asthma.   "
239974|NCT00989534|"     This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk     of diabetes, independently of the amount of sleep loss.   "
239987|NCT00989703|"     The purpose of the study is to evaluate the safety and tolerability of multiple increasing     oral doses of GLPG0259 compared to placebo.      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing     oral doses, and potential drug-drug interaction with single dose methotrexate will be     assessed.   "
239998|NCT00989846|"     Disease related biomarkers have been established decades ago, e.g. blood glucose for diabetes     diagnosis and management. Their discovery has grown dramatically during the past decade and     they have the potential to lead the physician in diagnosis -especially differential diagnosis     - and therapy.      However, a specific serum-biomarker in lung diseases has not been established. Aim of the     current study is to to measure lung specific proteins in the serum in patients with various     lung diseases and to correlate those with disease severity, lung function and other     laboratory results   "
239975|NCT00989547|"     Type 1 diabetes (T1D) is still associated with tremendous morbidity and premature mortality.      Patients require multiple daily insulin injections throughout their lives as well as close     monitoring of their diet and blood sugar levels to prevent complications. Unfortunately,     there is presently no permanent cure for diabetes. Whole pancreas or islet cell     transplantation is available only to a very limited number of patients and necessitates     potential lifelong immunosuppressive therapy. Autologous stem cell transplants have been used     successfully for ALL (acute lymphoblastic leukemia), AML (acute myeloblastic leukemia) and     for the treatment of a variety of cancers including breast cancer and neuroblastomas, and     more recently for the treatment of autoimmune disorders such as multiple sclerosis (MS),     lupus-like disease, and rheumatic disorders. Recently it was shown that bone marrow-derived     stems cells transplanted into diabetic mice led to reduced hyperglycemia within 7 days after     transplantation and was sustained until they were sacrificed at 35 days post-transplantation.     The investigators' goal is to transfuse autologous umbilical cord blood into 23 children     (Germany 10 and 20 Controls) with T1D in an attempt to regenerate pancreatic islet insulin     producing beta cells and improve blood glucose control. As secondary goals, the investigators     aim to track the migration of transfused cord blood stem and study the potential changes in     metabolism/immune function leading to islet regeneration.   "
239976|NCT00989560|"     This randomised, controlled study aims to evaluate the impact of endoscopic assessment, and     adjustment of therapy, after surgery in patients with Crohn's disease. The primary endpoint     is the severity of endoscopic recurrence. In addition, tissue will be collected for     microbiological and immunological analysis.   "
239977|NCT00989573|"     The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the     optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8     weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid     [5-ASA] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active     Crohn's disease.   "
239978|NCT00989586|"     A phase I dose escalation study of veltuzumab and milatuzumab in relapsed and refractory     B-cell NHL. The phase I study will be followed by a pilot phase II study.   "
239979|NCT00989599|"     To verify the efficacy of topical applications of Chamomilla recutita infusion for phlebitis     treatment, before dose response curve study and pilot study.   "
239980|NCT00989612|"     This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK     Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged     20-64 years.   "
239981|NCT00989625|"     This is a pharmacokinetic (PK) study designed to investigate a combination product containing     sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg     sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg naproxen sodium, 85mg     sumatriptan/500mg naproxen sodium) in adolescent migraine patients. The same doses will be     also administered to a group of healthy volunteer (HV) adult subjects and the PK parameters     will be compared between these two groups and between doses.   "
239982|NCT00989638|"     The purpose of this study is to develop a coordinated, standardized screening program for the     early detection of breast cancer in high-risk women. This would include Breast Mammography     and Magnetic Resonance Imaging (MRI) examination of your breasts. The University of Chicago     Department of Radiology is performing research to develop better ways of imaging the breast.     The investigators would like to be able to reliably identify abnormal tissue and determine     whether abnormal areas contain cancer without surgical procedures (i.e., a biopsy which     involves removing breast tissue with a needle or surgical instrument). Annual mammography has     already been recommended for the patient based on family history or personal history of     cancer. In young women, dense breasts sometimes make it difficult to find abnormal changes on     breast cancer screening (mammograms). MRI, in combination with mammography, may increase the     rate of detection of early cancers. In addition, MRI can provide better images of breast     tissue. The investigators hope to prove that combining multiple screening measures including     biomarkers improves the chances that, if you have a small cancer or pre-cancer, it will be     found early. This study will also evaluate quality of life measures during breast cancer     screening and compare breast MRI and mammogram in a high-risk population. The investigators     will establish a database of clinical characteristics, blood biomarkers and interventions     that will be saved for future analysis and aid in the development of more effective screening     in high-risk women. This research will also help us develop tools for studies in the future.   "
239983|NCT00989651|"     This phase I trial studies the side effects and best dose of veliparib when given together     with carboplatin, paclitaxel, and bevacizumab in treating patients with newly diagnosed stage     II-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer. Veliparib may stop     the growth of tumor cells by blocking some of the enzymes needed for cells to repair     themselves from damage and survive. Drugs used in chemotherapy, such as carboplatin and     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab, a     type of drug called a monoclonal antibody, blocks tumor growth by targeting certain cells and     preventing the growth of new blood vessels that tumors need to grow. Giving veliparib     together with carboplatin, paclitaxel, and bevacizumab may kill more tumor cells.   "
239984|NCT00989664|"     The results from Phase 1/2 (RIT-I-000) and Phase 2 (RIT-II-001) studies of Tositumomab and     Iodine I 131 Tositumomab (TST/I-131 TST) demonstrated that TST/ I-131 TST produced a high     response rate in patients with chemotherapy-relapsed/refractory, low-grade or transformed     low-grade Non-Hodgkin's Lymphoma (NHL). On the basis of these results this study was designed     to compare the efficacy of TST/ I-131 TST to the last qualifying chemotherapy regimen in     patients with chemotherapy-refractory, low-grade or transformed low-grade NHL.   "
239985|NCT00989677|"     Background of the study:      Rheumatoid Arthritis (RA) is an autoimmune disease. There are four stages of the disease:        1. Synovial inflammation        2. Swelling of synovium        3. Pannus formation        4. Advanced bone and cartilage destruction Currently, there is no cure for RA, making the          disease a chronic condition. RA is more prevalent in elderly and women. With medication          it is possible to delay the onset of complications. Over the last decade, the treatment          of RA has changed. Where treatment was palliative until pain medication was ineffective,          the treatment is now more aggressive with early administration of disease modifying          drugs (DMARDs).      The treatment for RA is staged. First, the patient receives generic, low-cost drugs. If this     treatment becomes ineffective, the treatment is adjusted with different and usually more     advanced drugs. Biologics are a category drugs that are considered most advanced and most     expensive.      For effective treatment, there are two unmet needs.        -  A tool to aid early diagnosis, as this allows early treatment and delay of complications          and physical restrictions for patients.        -  A safe, simple and cheap tool to monitor disease progress to allow traceable,          operator-independent informed decisions on treatment adjustments.      Non-invasive optical methods offer several advantages over existing modalities. Optical     contrast can be related to physiological parameters in the body, such as blood concentration     and oxygenation. At relevant wavelengths and intensities, optical radiation is completely     harmless. The cost of optical methods is low compared to other modalities. An important     application, where optical methods can help diagnosis and treatment is detection of     inflammation of joints in patients suffering from rheumatoid arthritis (RA). Due to the     highly scattering nature of tissue, non-invasive optical methods for medical imaging are     limited to the extremities of the human body. For application in joint diseases, this is     acceptable, because imaging of hands can provide sufficient clinical information.      Objective of the study:      Primary objectives:      This is a retrospective, nonrandomized controlled observational study, conducted in a single     center to evaluate the potential of optical attenuation measurements to establish disease     activity for rheumatoid arthritis patients.      Secondary objectives:      Establish parameters from transient optical transmission measurements of the joint that     relate to clinical evaluation results of individual joints Evaluate relation between disease     activity (DAS-28 score) and the optical attenuation spectra of the fingers of a patient.      Study design:      This is a cross sectional, nonrandomized controlled observational study, conducted in a     single center to evaluate the potential of optical attenuation measurements to establish     disease activity for rheumatoid arthritis patients.      Study population:      The subject population will be patients visiting the Regionaal Reuma Centrum Eindhoven for     rheumatoid arthritis. Patient visiting this center will represent a cross section of RA     patients that are taken care of in an outpatient setting.      Primary study parameters/outcome of the study:      Primary endpoint is a successful measurement of optical attenuation of a joint and the part     of the finger next to the joint before, during and after two consecutive restrictions of     venous blood flow by means of a pressure cuff.      Secondary study parameters/outcome of the study (if applicable):      Secondary endpoints are unsuccessful measurements related to early termination of the     measurement related to patient discomfort or safety and equipment or software failure.   "
239986|NCT00989690|"     RATIONALE: Studying the proteins expressed in samples of blood and tissue from patients with     cancer may help doctors identify biomarkers related to cancer. It may also help doctors     predict how patients will respond to treatment.      PURPOSE: This randomized phase III trial is studying blood and tissue samples in predicting     response to second-line therapy using erlotinib hydrochloride or chemotherapy in patients     with advanced non-small cell lung cancer.   "
239999|NCT00989859|"     The researchers want to determine if ambient light, plethysmographic , can monitor reliably     heart rate, respiration rate and oxygen saturation in infant patients in a hospital setting.   "
239988|NCT00989716|"     Nitric oxide is a multimodal candidate treatment for acute stroke having a number of     properties which may be beneficial in acute stroke, including lowering blood pressure,     causing cerebral vasodilation, and improving central and systemic haemodynamics. Nitric oxide     donors are effective in experimental stroke and pilot studies in patients suggest that one,     glyceryl trinitrate, can be delivered easily in a transdermal preparation. Around half of all     patients admitted with acute stroke are taking antihypertensive therapy immediately prior to     their stroke. No data exist as to whether it is beneficial or safe to stop or continue this     treatment during the acute phase. ENOS is a prospective, international, multicentre,     randomised, parallel-group, blinded, controlled, collaborative, factorial trial designed to     test two questions related to the management of blood pressure immediately post-stroke:        1. The safety and efficacy of nitric oxide, given as transdermal glyceryl trinitrate.        2. The safety and efficacy of stopping or continuing prior antihypertensive medication.      Previously independent adult patients who are conscious and have residual limb weakness are     eligible for enrollment. Central randomisation will be performed via the internet. Treatment     is initiated within 48 hours of stroke onset and is given as daily glyceryl trinitrate     patches for 7 days. A computed tomography (CT) scan is required within 7 days of     randomisation. Early follow-up is performed locally over the 7 days of treatment, including     blood pressure, early stroke events, and adverse events. Telephone central follow-up by the     trial co-ordinating centre will be performed at 3 months. The primary outcome is combined     death or dependency (modified Rankin Score >2).   "
239989|NCT00989729|"     The purpose of this study is to attenuate the systemic inflammatory response after     Endovascular repair of abdominal aortic aneurysms, by administration of a single preoperative     dosage of Methylprednisolone.   "
239990|NCT00989742|"     The purpose of the study is to test if the drug doxycycline is effective in slowing the     progression of lung disease in LAM. Lymphangioleiomyomatosis (LAM) is a rare lung disease     which affects young women. Women with LAM develop enlarged air spaces in the lungs called     cysts, caused by an excess of matrix metalloproteinases (MMPs), protein-digesting enzymes.     LAM is associated with kidney tumours, called angiomyolipomas, and causes recurrent lung     collapse, breathlessness and death or need for lung transplant. There is no proven treatment.     Doxycycline, a commonly used antibiotic can block MMP production and a small number of     patients have shown some benefit from doxycycline. The investigators will perform a study to     test if doxycycline can slow the fall in lung function in patients with LAM. Forty patients     who consent to participate will take doxycycline or a placebo (dummy) tablet for two years in     addition to their standard treatment.   "
239991|NCT00989755|"     The purpose of this study is to evaluate Fax to Quit (F2Q) - a strategy that links state     quitlines to health care delivery systems. FQ capitalizes upon the healthcare visit as an     opportunity for intervention, consistent with the finding that approximately 70% of smokers     visit a primary care physician each year. Successful integration of quitlines into healthcare     delivery will transform regular healthcare visits into easily implemented, cost-beneficial     avenues via which smokers all across America will be routinely inducted into effective     cessation intervention. F2Q will be evaluated as follows:        1. Does F2Q increase contacts and quality contacts, between the quitline and patients who          smoke and receive health care at a participating clinic? A quality contact is defined          as a quitline referral that results in the individual enrolling in the quitline          counseling services. This aim will be assessed by measuring the rates of quitline          referrals in 49 clinics before and after F2Q has been implemented.        2. Are contact rates and enrollment rates of F2Q increased by Enhanced Academic Detailing          at clinic sites (with enhanced academic detailing comprising ongoing training/technical          assistance as well as performance feedback)?        3. What are the features of the Fax to Quit (F2Q) and Fax to Quit plus Enhanced Academic          Detailing (F2Q + EAD) interventions that key clinic personnel found helpful and easy to          implement, as well as features that were unhelpful and difficult? This information will          be gathered in qualitative assessments that also will identify clinic strategies and          organizational features that facilitated successful implementation.        4. What are the incremental costs of instating and sustaining F2Q and F2Q + EAD and how do          these costs compare to other quitline promotional strategies (e.g., paid media,          medication give-away programs)?   "
239992|NCT00989768|"     The objective of this study is to compare the field of effects of the botulinum toxins     (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such     as more detailed data on the effectiveness in reduction of wrinkles and duration of action on     the upper part of the face of both products, trough scales and photographs evaluations.   "
239993|NCT00989781|"     Jeffrey Chang MD is conducting a research study to learn more about the increased male     hormone levels, otherwise known as androgens, seen in women with polycystic ovary syndrome     (PCOS). Women with PCOS have ovaries that are comprised of many cysts, or follicles. They     also have irregular or absent menstrual periods and symptoms of increased male hormones, such     as facial hair or acne. In each part of the study (except part 4 which is for PCOS women     only) we will be comparing responses of PCOS women to normal controls   "
239994|NCT00989794|"     This is a single arm, open label multi-center study to determine safety and the performance     of the treatment of cartilage lesions located on the femoral condyle with GelrinC.      Patients meeting inclusion/exclusion criteria at screening will be enrolled into the study,     and will receive treatment implantation into their cartilage lesions.      Treatment will consist of GelrinC implantations at the symptomatic lesion of femur rated as     ICRS III, or IVA with less than 6 mm of bone loss below the subchondral plate.      The patients will undergo a rehabilitation program during the follow up period.   "
239995|NCT00989807|"     This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior to     its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa     airway infection who have limited treatment options and are at risk for disease progression.   "
239996|NCT00989820|"     The purpose of this study is to determine whether hyperbaric oxygen therapy is effective in     the treatment of osteoradionecrosis (late damage after radiotherapy) of the jaw.   "
239997|NCT00989833|"     1. The primary objective of this study is:             -  To evaluate the magnitude of the protective effect of the combination of budesonide               and formoterol on an as-needed basis compared to the use of terbutaline as-needed               on exercise induced bronchoconstriction in adults and adolescents with mild               intermittent asthma        2. The secondary objectives of this study are:             -  To evaluate the magnitude of the protective effect of the combination of budesonide               and formoterol as-needed compared to regular once daily use of budesonide plus               terbutaline as-needed on exercise induced bronchoconstriction in adults and               adolescents with mild intermittent asthma             -  To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and               regular use of budesonide + terbutaline as-needed as terms of adverse event   "
240001|NCT00989885|"     The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a     recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients     attended this study, that sought the CESF to probable diagnosis of some sleep disorder. The     data were collected from records, wich are of questionnaires, including the ESE, prepared by     the CESF professionals and responded, previously, by the own patients. The study compared the     result obtained in the scale of Epworth with the data of polysomnography. The analysis of     data was performed using the SPSS, based on descriptive and inferential statistics, being     used the average considering the standard deviation, and, to the crossing of variables, was     used the chi-square test of Pearson, considering as significant statistically values of     p<0.05. The results showed that gender, age and BMI are predisposing factors to SOSA.   "
240002|NCT00989898|"     Children and adolescents with type 1 diabetes need regular insulin injections or continuous     insulin delivery with an insulin pump in order to keep blood sugar levels normal. The     investigators know that keeping blood sugars in the normal range can prevent long term     diabetes complications involving the eyes, kidneys and heart. However, achieving treatment     goals can be very difficult as the tighter the investigators try to control blood glucose     levels, the greater the risk for the young person to develop symptoms and signs of low     glucose levels (hypoglycaemia). This is a particular problem at night. One solution is to     develop a system whereby the amount of insulin injected is very closely matched to the blood     sugar levels on a continuous basis. In a closed loop system, for example, a continuous     glucose sensor communicates with a computer algorithm which drives an insulin pump. The     investigators have been developing such a system in Cambridge over the last year with funding     from the Juvenile Diabetes Research Foundation. The investigators have found that this system     is very effective at preventing hypoglycaemia in young people with diabetes.      Until now the information from the sensor has been entered manually into the computer and the     pump settings have also been changed manually. The investigators now need to move onto the     next step which is to fully automate the system. The studies will be done in a clinical     research facility. The investigators will study the young people on two nights in order to     find out if the closed loop system started early in the evening is as effective as when it is     started later before sleep. 12 young people will be recruited from diabetes clinics in the     East Anglia region. The studies will provide further important information concerning the     safety, efficacy and utility of closed loop systems.   "
240003|NCT00989911|"     Recent studies have shown beneficial effects of sildenafil in patients with single ventricle     congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug     with similar effects, will have similar benefit in this patient population.   "
240004|NCT00989924|"     The purpose of this study is to evaluate the correlation among magnetocardiography (MCG)     patterns and various known cardiovascular risk factors.   "
240005|NCT00989937|"     The objective of the study is to compare the efficacy of intranasal oxytocin versus     intranasal placebo to improve anxiety symptoms in patients with a variety of anxiety     disorders.   "
240006|NCT00989950|"     Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana     (methylphenidate) patch for a longer time then 9 hours, many children report short sleep     latencies and better quality of sleep.   "
240007|NCT00989963|"     This is a 12-week, international, multicenter, double-blind, three-group, dose-response study     to assess the safety and efficacy of BPS-MR in patients with PAH. Eligible patients will have     been previously diagnosed with PAH and will be on a stable course of an ERA and/or PDE-5     inhibitor for at least 60 days prior to Baseline.      Patients will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio and will be     stratified by PAH background therapy (Endothelium Receptor Antagonist (ERA),     Phosphodiesterase-5 (PDE-5), and both). The treatment groups consist of one Maximum Tolerated     Dose (MTD) and two Fixed Dose (FD) groups. Following randomization, patients will begin     taking active drug (60µg) orally twice daily. Patients will visit their investigational site     at Week 6 and Week 12 for study evaluations.   "
240008|NCT00989976|"     The hypothesis for this study is that some individuals may be at much higher risk to develop     type 2 diabetes and that the individual diabetes risk will be predicted by the individual     level of slow wave sleep activity (SWA).   "
240009|NCT00989989|"     This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as     adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian     patients with visual impairment due to Diabetic Macular Edema (DME).   "
240010|NCT00990002|"     Investigating different bioactive ingredients in children's beverages and the effect on blood     serum markers.   "
240011|NCT00990015|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics     (understanding how a drug is absorbed and moves through the body) and pharmacodynamics     (understanding the effects of a drug on certain target sites of activity in the body).   "
240012|NCT00990028|"     The purpose of this study is to determine whether rosuvastatin could alter the immunological     response after head injury by modulating TNF-alpha,IL6,IL-1.   "
240013|NCT00990041|"     Background and Objective: It has been reported that peripheral blood mononuclear cells (PBMC)     from periodontal patients have a different profile of cytokine release when compared to the     ones of healthy patients. Cigarette smoking is a recognized risk factor for periodontitis and     is known to affect the systemic and local immune responses. Thus, the aim of the present     study was to obtain preliminary data about the interaction of periodontal condition and     smoking in the secretion of some cytokines by PBMC.      Material and Methods: PBMC samples were isolated from 19 donors, divided into generalized     chronic periodontitis (P; n=10) and periodontal health (H; n=9) groups. In addition, the     smokers and non-smokers of each group were separately evaluated: SP- smokers with severe     generalized chronic periodontitis (n=5); SH- periodontally healthy smokers (n=5); NSP-     non-smokers with severe generalized chronic periodontitis (n=5) and NSH- periodontally     healthy non-smokers (n=4). Cells were incubated for 24-48 hours in 500 µL wells containing     RPMI 1640 and stimulated with 1.0 ng/mL of E. coli LPS. Supernatants were used to quantify     the amounts of TNF-α, IL-6, IL-8 and IL-10 released using ELISA kits.   "
240381|NCT01002950|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.   "
240014|NCT00990054|"     The purpose of this research study is to determine if plerixafor can make cells more     sensitive to killing by cytarabine and daunorubicin, an anti-cancer drug regimen referred to     as 7+3 that is commonly used in treating acute myeloid leukemia (AML). In this study,     plerixafor is used with treatments cytarabine and daunorubicin and with and without     granulocyte-colony stimulating factor (GCSF). Subjects will be monitored to see how well they     tolerate the use of these drugs together and how well they work to treat the leukemia.      The purpose of the study is to determine the maximum tolerated dose (MTD) per plerixafor     dosing schedule (once daily [QD] or twice daily [BID]), and/or recommended phase 2 dose     (RP2D), by assessing safety and tolerability of plerixafor (Mozobil®) when used in     combination with cytarabine and daunorubicin, and with and without granulocyte-colony     stimulating factor (G-CSF)   "
240015|NCT00990067|"     The purpose of this study is to determinate the effect of a pre-treatment with the combined     serotonin (5-HT) and norepinephrine (NE) transport blocker duloxetine on the pharmacodynamics     and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy). The     investigators hypothesize that duloxetine will attenuate the subjective and cardiovascular     response to MDMA.   "
240016|NCT00990080|"     To demonstrate the safety and immunogenicity of two mixed primary immunization schedules:     Pediacel® at 2 and 4 months of age followed by one dose of Infanrix™ IPV/Hib at 6 months of     age; and, Infanrix™ IPV/Hib at 2 months of age, followed by Pediacel® at 4 and 6 months of     age.   "
240017|NCT00990093|"     The purpose of this study is to evaluate that the test catheter is no less accepted than the     SpeediCath (SC) catheter.   "
240018|NCT00990106|"     The purpose of this study is to determine whether prazosin will:        -  reduce the incidence of nightmares and sleep disturbance        -  increase functioning and sense of well being in combat-trauma exposed Operation Iraqi          Freedom/Operation Enduring Freedom (OIF/OEF) Veterans.   "
240019|NCT00990119|"     The aim of this study is to see if the Vapotherm High Flow Therapy (HFT) device is effective     to provide breathing support to patients with Chronic Obstructive Pulmonary Disease or COPD.     The investigators believe that patients using HFT will not require as much use of therapies     that provide pressure through a face mask, and are already recognized by FDA as support     therapies for respiratory insufficiency.   "
240020|NCT00990132|"     This study is designed to investigate the effect of home mechanical ventilation (HMV) in     patients with severe chronic obstructive pulmonary disease (COPD). The purpose of the trial     is to test the hypothesis that HMV and longterm oxygen therapy (LTOT) increases admission     free survival compared with LTOT alone. More specifically, compared with LTOT, HMV and LTOT     reduces hospital re-admission in COPD patients who remain persistently hypercapnic following     an acute exacerbation requiring non-invasive ventilation (NIV).   "
240021|NCT00990145|"     This was a Phase I, single-center, randomized, double-blind, placebo-controlled, ascending     multiple dose study to evaluate the safety, tolerability, and pharmacokinetics of orally     administered EDP-322 in healthy adult volunteers.   "
240022|NCT00990158|"     Warfarin is highly effective for the prevention of both first and recurrent thrombotic     events, however even minor excursions outside the reference INR range of 2.0 to 3.0 are     associated with bleeding or thrombotic complications. The importance of maintaining the INR     within the desired interval has led to the concept of time in therapeutic range (TTR) - the     total proportion of time that the INR is between 2.0 and 3.0. The investigators propose a     multicentre, double blind, randomized trial which will determine if 0.150 mg of oral vitamin     K increases time in the therapeutic range for patients receiving warfarin.   "
240023|NCT00990171|"     A prospective long-term follow up of peritoneal dialysis patients' outcome correlates with     nutritional status and body composition.   "
240024|NCT00990184|"     The objective of this study is to determine the effect of 8 weeks of treatment with     colesevelam HCl 3.75 g once daily with the evening meal on ß-cell function by evaluating the     acute insulin response (AIRg) to an intravenous glucose load in subjects with prediabetes     (impaired fasting glucose).   "
240025|NCT00990197|"     Continuing to smoke after having a heart attack greatly increases the risk of death and     cardiac illness. The nicotine patch is a commonly used pharmacotherapy for smoking cessation     and has great potential to help heart attack patients quit smoking. However, due to safety     concerns, physicians are often hesitant to prescribe the nicotine patch to patients who have     just suffered a heart attack. The STADIA pilot study will assess the feasibility of a     large-scale clinical trial investigating safety and efficacy outcomes associated with the     nicotine patch immediately following a heart attack. Eligible subjects will be randomized     within 48 hours of suffering a heart attack to wear a transdermal nicotine patch on either     day 1 or day 2 of the study period. The nicotine patch will deliver nicotine to the patient     over the period of 24 hours. Patients will be advised to discuss smoking cessation strategies     with their treating physician and subsequent care will be left to the discretion of this     physician. The duration of ischemia (loss of blood flow in the heart), patient adherence,     incidence of arrhythmia (disorder of the heart rate or rhythm), heart rate, and blood     pressure within the two groups will be used to evaluate the safety of transdermal nicotine     use immediately after a heart attack.   "
240026|NCT00990223|"     To evaluate the changes in serum aldosterone and plasma renin activity on Day 0 and on Days 1     and 10 after administration of 100 mg of eplerenone daily for 10 days.   "
240027|NCT00990236|"     The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many     times enoxaparin (or Lovenox®) is given to patients who are at a higher risk of developing     clots in their legs or lungs. Recent data suggest that a standard dose of Lovenox may not     fully prevent the development of these clots especially in critically ill or obese patients.     Routine enoxaparin dosing can also result in bleeding complications. Thrombelastography     (TEG®) can be used to measure how blood clots. The purposes of this study are:        -  to learn if the TEG® can better guide physicians in prescribing an effective dose of          Lovenox compared to standard doses recommended by the drug company in preventing blood          clots from developing in the legs and lungs, and        -  to compare the development of blood clots in patients receiving the standard dose of          enoxaparin compared to patients receiving a TEG® guided dose of enoxaparin.        -  to determine if TEG guided dosing results in decreased bleeding complications compared          to standard dosing.   "
240029|NCT00990262|"     The goal of this research is to determine noninvasively whether detection of coronary     stenosis and plaque by multidetector computed tomography (MDCT) in patients with acute chest     pain suspected of acute coronary syndrome (ACS) enhances triage, reduces cost and is cost     effective. Among the 5.6 million patients with ACP presenting annually in emergency     departments (ED) in the United States, a subgroup of two million patients is hospitalized     despite normal initial cardiac biomarker tests and electrocardiogram (ECG). This subgroup is     at low (20%) risk for ACS during the index hospitalization. Most (80-94%) patients with a     diagnosis of ACS have a significant epicardial coronary artery stenosis ( >50% luminal     narrowing). However, in -10% of patients non-stenotic coronary plaque triggers events, i.e.     vasospasms, leading to myocardial ischemia. Since the absence of plaque excludes a coronary     cause of chest pain, these patients could in theory be discharged earlier reducing     unnecessary hospital admissions. Recent publications demonstrate high sensitivity and     specificity of MDCT for the detection of significant coronary stenosis compared with coronary     angiography and the detection of coronary plaque as validated with intravascular ultrasound.     Using 64- slice MDCT we propose to study 400 patients with ACP, negative initial cardiac     biomarkers and non-diagnostic ECG. We will analyze MDCT images for the presence of     significant coronary artery stenosis and plaque and correlate the data with the clinical     diagnosis of ACS (AHA guidelines) during the index hospitalization to determine the     sensitivity and specificity. MDCT data, risk factors, and the results of standard diagnostic     tests available at the time of MDCT will be used to generate a multivariate prediction     function and derive a clinical decision rule. Based on this decision rule we will compare the     diagnostic accuracies and cost effectiveness of competing strategies. We hypothesize that an     MDCT- based diagnostic strategy will reduce the time to diagnosis of ACS, number of     hospitalizations, and absolute cost of management of patients with acute chest pain compared     to standard clinical care and is cost effective.   "
240030|NCT00990275|"     Alcohol has well-established consequences in the lung including increased risk for upper     respiratory tract infections, pneumonia and acute respiratory distress syndrome (ARDS). There     have even been a few reports of alcohol-induced asthma. Data from the investigators'     laboratory have established that the airways are specifically impacted by alcohol exposure.     Because the airways are heavily exposed to the vapor phase of alcohol during drinking and     airway motor tone is modulated by cAMP, the investigators speculated that airway bronchial     motor function would be altered in mice fed alcohol. The investigators' preliminary studies     demonstrate that brief alcohol administration significantly attenuates airway     hyperresponsiveness (AHR) in a mouse model. This novel finding has led us to hypothesize     that:      Alcohol exposure modifies airway hyperresponsiveness through a cAMP/NO- dependent mechanism.   "
240031|NCT00990288|"     The purpose of this study is to determine if the agent, Floseal, can decrease the amount of     blood patients lose after total knee replacement (TKR) surgery. If this product can be found     to have an effect on bleeding, it may potentially reduce the problems associated with     bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood     transfusion. The subject's overall participation will be over a period of 6 weeks.   "
240032|NCT00990301|"     The purpose of this study was to evaluate the relative bioavailability of Paddock     Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets     with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets,     under fasting conditions.   "
240033|NCT00990314|"     This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and     have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release     (BPS-MR) tablets.   "
240034|NCT00990327|"     The purpose of this study is to see whether apadenoson is as effective as adenosine when used     as a pharmacological stress agent in myocardial SPECT-Imaging to detect defects in the supply     of blood to the heart muscle (myocardial perfusion defects). The study will also look at     whether apadenoson is better tolerated than adenosine when used in SPECT-MPI.   "
240035|NCT00990340|"     The purpose of this study is to obtain psychological response and user preference information     on the use of the T jet® device versus the traditional subcutaneous injection administration     of Tev Tropin®.      This study will compare subject-reported injection anxiety immediately before the     administration of each dose of Tev-Tropin® between a needle-syringe injection method and a     needle-free injection method (T-jet®)   "
240036|NCT00990353|"     This study examines methods to better predict improvement of a hidden disability of     functional vision, spatial neglect, following stroke. Spatial neglect is a tendency to make     visual judgment and movement errors mislocating the body and objects in space. The     investigators are using specialized statistical methods to compute the proportion of     improvement accounted for by personal characteristics of each stroke survivor, the proportion     of improvement accounted for by the unique visual-spatial errors made by each subject, and     the proportion of improvement accounted for by each treatment administered. The investigators     will also examine whether brain imaging predicts how rapidly improvement occurs. Lastly, the     study tests whether improvements that are meaningful to the survivor can be measured in a way     that still allows detection of small and scientifically eloquent performance changes.   "
240037|NCT00990366|"     Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage     (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids     through a stent is thought to be one of the causes of cholangitis. Stents with antireflux     valves are designed to reduce the reflux from the bowel. The purpose of the study is to     investigate prospectively whether it is possible to reduce the amount of infection and thus     obstruction of biliary stent by using a stent with an antireflux valve compared to a normal     stent without an antireflux valve.   "
240038|NCT00990379|"     This pilot study will assess the feasibility of using heavy water as a safe 'tracer' for     biomarker studies of diseases of the brain and spinal cord, that, together, are also called     the central nervous system (CNS). Heavy water, also called deuterated water or D20, is the     same as normal drinking water except the hydrogen atoms have been replaced by deuterium, a     naturally occurring isotope of hydrogen. In particular, this study will use heavy water to     define: 1) The rate of immune cell proliferation (growth) in the cerebrospinal fluid (CSF)     compared to blood. This study will be examining a particular type of immune cell called T     lymphocytes. 2) This study will also examine selected molecules generated by nerve cells of     the CNS to understand their rate of secretion and turnover in healthy control participants,     HIV-1-infected participants and participants with a non-HIV-related neurodegenerative disease     such as Parkinson's disease (PD).      This study will involve the administration of heavy water orally for either seven days, 12     days or six weeks. Measurements will be taken by lumbar puncture (LP, also known as a spinal     tap). Blood (approximately five tablespoons per visit) will also be obtained at each of the     lumbar puncture appointments.      If this method can be used to establish the rates of immune cell turnover and the production     rates of neuronal molecules using cerebrospinal fluid, it will provide unique data that is     important to understand chronic neurodegenerative conditions, like PD, and to measure     responses to targeted therapies.      Hypothesis:        1. D2O, administered orally, can be used to measure the proliferation rates of CSF T cells          (and, eventually, of their major phenotypic subsets).        2. D2O can be used to assess the turnover and production rates of CNS constituents that are          normally or pathologically shed or secreted into the CSF, including (eventually): cargo          molecules transported specifically in neurons in the CNS, such as chromogranin-A and -B,          neuregulin-1 (specifically the extracellular secreted ectodomain of neuronal          differentiation factor (NDF) isoform type α1, α2, β1, and the acetylcholine receptor          inducing activity isoform (ARIA), secreted amyloid precursor protein (sAPP),          alpha-synuclein; and APP metabolites amyloid beta (Aβ) 41 and 42.   "
240040|NCT00990405|"     The role of Helicobacter pylori infection in functional dyspepsia remains controversial.     Several randomized controlled trials in western countries have shown no significant advantage     over placebo. But some recent studies in Asian population were different compared to the     result of studies in the Western population. At the present time, it seems to be difficult to     conclude the efficacy of the H.pylori eradication therapy in patients with H. pylori-infected     functional dyspepsia.      The investigators hypothesize that eradication of Helicobacter pylori has a sustained global     symptom improvement in patients with H. pylori infected functional dyspepsia.   "
240041|NCT00990418|"     The purpose of this study is to confirm that the two forms of the device the Integrated     E-TRANS (fentanyl HCl) system and the Separated (Two-Part) E-TRANS (fentanyl HCl) System     provide the equivalent blood levels of medication (fentanyl HCL).   "
240042|NCT00990431|"     Ablative fractional lasers were introduced for treating facial rhytides in an attempt to     achieve results comparable to traditional ablative resurfacing but with fewer side effects.     However, there is conflicting evidence on how well this goal has generally been achieved as     well as on the comparative value of fractional CO2 and Er:YAG lasers. The present study     compares these modalities in a randomized controlled blinded split-face study design:      28 patients were enrolled and completed the entire study. Patients were randomly assigned to     receive a single treatment on each side of the peri-orbital region, one with a fractional CO2     and one with a fractional Er:YAG laser. The evaluation included Fitzpatrick wrinkle score,     profilometric measurement of wrinkle depth (both before and 3 months after treatment) as well     as assessment of side effects and patient satisfaction (1, 3, 6 days and 3 months after     treatment).   "
240043|NCT00990444|"     Insulin is normally not bioavailable when taken through the oral route, as degradation of the     molecule may occur both in the ventricle and in the intestine. Oral administration with     uptake from the lesser intestine would offer major advantages if made possible. It would     offer a simple non-injection method to administer insulin in connection with a meal and     absorbed insulin would enter the blood stream and mimic the natural distribution in the body     with a first pass through the liver. The sponsor of this study has developed a novel oral     insulin formulation that is based on a proprietary dextran matrix. The investigational drug     is a capsule containing 100 IU of human insulin in dextran matrix.      The primary objective of this study is to establish the safety, tolerance and PD profile     (i.e. pharmacodynamic parameters for glucose and insulin) of peroral insulin in dextran     matrix in patients with type 2 diabetes.      The phase I/II study protocol consists of two parts; part 1 (dose finding) and part 2 (dose     verification). In study part 1 single escalating doses of oral insulin or placebo is given to     the test subjects. Capillary blood glucose is used to assess the insulin effect.     Subsequently, in study part 2, the investigational drug will be administered 3 times daily on     6 consecutive days. The starting dose of part 2 will be the lowest effective dose found in     study part 1. Dose escalation will be done in increments of 100 IU. The total number of     subjects will be 32 (for part 1 and 2 combined).   "
240044|NCT00990457|"     Abdominal obesity, which is affected by a lack of physical activity and excess weight, put     people at an increased risk of cardiovascular disease. This study will compare the effects of     two different dietary approaches to weight loss, each combined with exercise, for their     effects on cardiovascular factors that are early predictors of future cardiovascular disease     in overweight and obese people with excessive weight around their waist. The two diets are a     low-carbohydrate versus a more traditional low-fat, low calorie diet.   "
240045|NCT00990470|"     In consideration of the limited supply of donor organs, the careful selection of transplant     candidates is essential to optimize patient outcome after transplantation. Therefore an     extensive evaluation of transplant candidates including among others     esophagogastroduodenoscopy (EGD) and colonoscopy has been implemented in our centre. The data     regarding the prevalence of upper and lower gastrointestinal (GI) pathology in transplant     candidates are contradictory and are based on only a few retrospective studies, which often     include only a subgroup of transplant candidates. The goal of this project is a prospective     evaluation of the frequency of GI pathologies in transplant candidates with specific focus on     the following questions:        1. Are there GI-pathologies that occur at a higher prevalence in transplant candidates than          described in the general population and is there an increase of GI-pathologies since the          introduction of the urgency-based organ allocation leading to sicker transplant          candidates?        2. What is the influence of endoscopic findings on patient management before          transplantation?        3. Which risk factors can be identified that predict the presence of GI-lesions?        4. Is there a subgroup of patients, in which screening colonoscopy before liver          transplantation can not be recommended considering the cost/benefit ratio?        5. Is there a correlation of endoscopic findings with outcome after liver transplantation          or with gastrointestinal complications during or after transplantation (e.g.          gastrointestinal bleeding, perforation or gastrointestinal malignancy)?   "
240046|NCT00990496|"     The primary purpose of this study is to determine the safety and efficacy of the infusion of     partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM     that have failed primary therapy.   "
240057|NCT00990639|"     Background:      Alcohol is one of principal causes of hepatic fibrosis. Although the most effective treatment     for alcoholic hepatic fibrosis is abstinence of alcohol consumption, additive treatment to     reduce the accumulation of scar tissue can accelerate the improvement of hepatic fibrosis in     alcoholic liver disease. The renin-angiotensin system can be an attractive antifibrotic     target in liver. Several lines of evidence indicate that overproduction of angiotensin II(ANG     II) in chronic liver injury stimulates the activation of hepatic stellate cells(HSCs)     attributed to fibrogenesis. Additionally, the antifibrotic effect of ANG II blocking agent     has been shown in various animal models and hepatitis C patients. Hence, drugs that inhibit     the renin-angiotensin system have promise in ameliorating hepatic fibrosis in chronic liver     injury. However, no study has been conducted in patients with alcoholic liver disease to     evaluate the effect ANG II type I receptor blocking agent on hepatic fibrosis.      Aim:      This study aimed to investigate the safety and the efficacy of chronic administration of     candesartan to hepatic fibrosis patients with alcoholic liver disease.      Methods      1) Patients with liver fibrosis(F2) were randomized to receive either the angiotensin     receptor blocker(ARB), candesartan(8 mg/day) with ursodeoxycholic acid(UDCA)(600 mg/day)(n =     42), or UDCA alone(n = 43) as control for 6 months. 2)All enrolled patients underwent liver     biopsies twice for measurement of fibrosis score, area of fibrosis and alpha-smooth muscle     actin(SMA) positive and hydroxyproline. 3) Transforming growth factor-beta1(TGF-beta1),     collagen-1, angiotensin II type I receptor(AT1-R), tissue inhibitor of     metalloproteinase-1(TIMP-1), Rac1 and p22phox which represent oxidant stress were also     measured by real-time RT-PCR before and after 6 months of therapy.   "
240047|NCT00990509|"     The purpose of this study is to find out what effects, good and bad, the medication Albumin     has on subjects who have experienced a type of stroke known as an intracerebral hemorrhage     (ICH). An ICH is when spontaneous bleeding into the brain occurs due to fragile blood     vessels.      This research is being done because currently there is no effective treatment for ICH.     However, study investigators believe that Albumin, the medication being tested in this study,     is safe and may help improve patient recovery from ICH over time.      Subjects will be enrolled in the study for a total of 90 days. Following enrollment, subjects     will be randomized to receive 3 daily injections of either Albumin or Placebo (liquid with no     drug), and will receive 3 brain MRI scans (with and without contrast), as described below.      All subjects will be monitored continuously through 96 hours after enrollment (5 days) in the     Georgetown ICU. Blood tests and clinical evaluations of neurological status, consisting of     questions about subjects' functional abilities and medical history, will occur in the     Georgetown ICU once every 24 hours through post-enrollment Day 5. Additionally, subjects will     receive daily chest x-rays, and daily EKGs (exams that monitor how your heart is doing by     placing electrodes, or small monitors, on your skin in specific locations).      Similar clinical evaluations will occur at Day 30 and Day 90. Should subjects be discharged     at these time points, day 30 assessments will occur over the phone, and day 90 assessments     will occur in-person at Georgetown University Medical Center.   "
240048|NCT00990522|"     Standard care of care and up to twelve (12) weekly debridements. Subjects randomized into the     weekly debridement group will receive up to twelve (12) debridement during the twelve (12)     weeks of the study. There will be two (2) subject groups in the study. Subjects will be     randomized into either the monthly debridement group or the weekly debridement group.   "
240049|NCT00990535|"     Octreotide (OCT) is a somatostatin analogue (SSA) available in a long-acting formulation,     conventionally administered every 28 days at the maximum dose of 30 mg. Together with     lanreotide, it is considered the therapy of choice in the control of endocrine syndromes     associated with neuroendocrine tumors (NET)s. A complete or partial clinical response to SSA     therapy is generally achieved in at least 50% of the patients with neuroendocrine syndrome.     Many studies reported a clinical response in 70-90% of functioning NETs. In about 36-50% of     the patients with progressive advanced well differentiated NET (WDNET), a stabilization of     disease occurs after treatment with subcutaneous OCT. By developing long-acting slow-release     SSA formulation, long-acting OCT (LAR), lanreotide-SR, lanreotide-Autogel, the patient's     compliance to SSA therapy was improved and escape from treatment, which was common with the     subcutaneous formulation, was avoided. However, rate of objective response was not     significantly improved as compared to short-acting SSA. On the other hand, it has to be     remarked that long-acting SSA are being used in NET patients at doses correspondent to the     low doses of short-acting formulation. The higher commercially available doses of LAR is 30     mg, which is assumed to be comparable to 300 µg of short-acting OCT in the therapy of     acromegaly.      Only one study was designed to investigate the use of high-dose LAR (160 mg every 28 days).     In this study, objective and hormonal responses in patients with progressive metastatic ileal     NET non-responder to standard doses, was significantly elevated. However, this compound has     never been commercialized and, of consequence, this first preliminary observation has not     been confirmed by further studies.      No systematic studies were performed with the commercially available long-acting SSA used in     high-dose treatments. In patients with progressive locally advanced or metastatic NET,     increase of the dose or reduction of the interval between injections is a relatively common     empirical clinical practice, but no studies have been performed to evaluate safety and     efficacy of this treatment schedule.   "
240050|NCT00990548|"     The purpose of the FIT-O study was to estimate the prevalence of having a caregiver (paid     and/or informal) among hospitalized cardiac patients by demographic factors such as patient     age and race/ethnicity, and to link caregiver status to clinical outcomes following     hospitalization. A secondary aim was to collect anonymous family tree data to provide an     estimate of the number of first degree family members, their basic demographics, and the     distance at which they live from the medical center.   "
240051|NCT00990561|"     This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy     of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate     0.05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the     treatment of stable plaque psoriasis. 1) Phase 1: Patients will be treated for two weeks with     combination therapy using Ultravate® ointment with Lac-Hydrin lotion and their psoriasis     plaques will be evaluated to test efficacy of the medication. Half the subjects will be     randomized to receive treatment with once a day Ultravate® ointment and twice daily     Lac-Hydrin lotion; the other half of subjects will receive twice daily Ultravate® ointment     with twice daily Lac-Hydrin lotion. Ultravate® ointment will be discontinued following two     weeks of treatment, in compliance with its FDA indication. Phase 2: The second treatment     phase will consist of a four-week observation period. Subjects will be re-randomized to     either continue using twice daily Lac-Hydrin lotion, versus no treatment. The purpose of this     second phase of the study is to investigate whether use of Lac-Hydrin monotherapy twice daily     can minimize risk of recurrence and maximize duration of therapeutic effect. Part of this     clinical study consists of the use of patient and physician satisfaction questionnaires.     These questionnaires will include questions about the satisfaction with the formulation of     each agent, questions about compliance with treatment, etc. Such questions could be used to     demonstrate patient and physician satisfaction with each agent, with combination therapy, and     to compare patient satisfaction rates among those randomized to once daily versus twice daily     application of Ultravate® ointment. The hypothesis is that Ultravate ointment once daily in     combination with Lac-Hydrin twice daily is equal in efficacy to Ultravate ointment twice     daily in combination with Lac-Hydrin twice daily.   "
240052|NCT00990574|"     The purpose of this study is to compare single shot versus sequential bolus spinal technique     via a catheter in patients undergoing Cesarean Section. We aim to determine which technique     results in less blood pressure reduction and subsequent vasopressor use.      Other study endpoints include the incidence of maternal post dural puncture headaches and     nausea and vomiting. In addition blood and CSF will be collected to see if biochemical     mediators are related to wound hyperalgesia and healing.   "
240053|NCT00990587|"     This is an open-label, single arm study. Approximately 3-30 patients will be enrolled.     Patients will receive Oral ciclopirox olamine (aqueous suspension), initial starting dose of     5 mg/m2/day administered as a single dose daily for 5 days. Three patients will initially be     treated at each dose level in sequential cohorts. Dose escalation will continue for each     subsequent cohort based on toxicity and plasma drug concentrations observed during the     previous cohort. Dose escalation will continue until establishment of the maximum tolerated     dose (MTD) has been met.      Patients who have demonstrated response to treatment, up to 6 total cycles of treatment may     be administered. If additional cycles are warranted, ciclopirox olamine will be given at the     same dose and frequency as the patient initially received.   "
240054|NCT00990600|"     Primary objective of the study is:      To verify if simplification of the antiretroviral regimen, measured as the reduction of pill     burden alone, may affect adherence rate of patients.   "
240055|NCT00990613|"     To estimate the absorption, safety, and tolerability of a dimebon transdermal solution     relative to the dimebon immediate release oral formulation.   "
240056|NCT00990626|"     The purpose of the study is to determine whether the Seroquel XR treatment for 6 months     improve the relapse prevention in schizophrenic outpatients   "
240240|NCT00993694|"     RATIONALE: Gathering information about how often methemoglobinemia occurs in young patients     receiving dapsone for hematologic cancer or aplastic anemia may help doctors learn more about     the disease and plan the best treatment.      PURPOSE: This research study is looking at methemoglobinemia in young patients with     hematologic cancer or aplastic anemia treated with dapsone.   "
240058|NCT00990652|"     Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     bortezomib before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed. Giving bortezomib together with temozolomide after surgery may kill     any tumor cells that remain after surgery.      This phase II trial is studying how well giving bortezomib before surgery followed by giving     bortezomib together with temozolomide after surgery works in treating patients with recurrent     malignant glioma.   "
240059|NCT00990665|"     The objective of this study is to assess the safety and efficacy of the Quartet™ lead and     Promote Q® device system in a patient population indicated for cardiac resynchronization     therapy.   "
240060|NCT00990678|"     The investigators want to investigate if HIV sero-positive males benefit from vitamin D     supplementation. The study runs in 16 weeks and the participants are treated with one of     three placebo controlled regimes (tablets):        1. Calcium        2. Calcium and 25-hydroxy-vitamin D        3. Calcium and 25-hydroxy-vitamin D and 1,25-dihydroxyvitamin D      The endpoints are:        -  Serum vitamin D        -  Parathyroid hormone        -  ionized calcium        -  T-lymphocyte fractions (naïve, mature, Tregs)        -  Osteocalcin (bone metabolism)   "
240061|NCT00990691|"     Rett syndrome is a neurodevelopmental disorder characterized by cognitive impairment,     communication dysfunction, stereotypic movement disorder, and growth failure. Rett syndrome     is caused by mutations in the Methyl CpG-Binding Protein-2 (MECP2) gene and has no treatment.      A mouse experimental model of Rett syndrome created by genetic invalidation of the MECP2 gene     is available. It had been then observed that adult MECP2-deficient mice show respiratory     alterations and found that endogenous noradrenaline helps to maintain a normal respiratory     rhythm. Desipramine, a selective inhibitor of norepinephrine reuptake, seems to be efficient     to reduce the respiratory alteration occuring in MECP2-deficient mice (Insem patent 2005,     Villard and Roux 2006).      The aim of the study is to evaluate these obtained results in MECP2-deficient mice on     patients with Rett syndrome.   "
240062|NCT00990704|"     This study is a exploratory comparison of the efficacy and safety of paricalcitol injection     with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis     with secondary hyperparathyroidism.   "
240063|NCT00990717|"     The purpose of this study is to find out how many irradiated natural killer (NK) cells can be     safely given to patients with cancer that has recurred after an autologous stem cell     transplant, and to see what effects (good and bad) it has on the patient and their cancer.     This research is being done because currently, there is no cure or effective treatment for     blood-borne cancers when it has come back after an autologous stem cell transplant.   "
240064|NCT00990730|"     The purpose of this study is to investigate the link between rheumatoid arthritis and     cardiovascular disease by studying inflammation, joint disease, cholesterol abnormalities,     and endothelial function.   "
240065|NCT00990743|"     The purpose of this study is to determine whether SYL040012 is safe for the treatment of     ocular hypertension and glaucoma.   "
240066|NCT00990756|"     The purpose of this study is to investigate safety and toleration of multiple inhaled doses     as well as the time course of PF-03526299 concentration in the blood following dosing by dry     powder inhaler.   "
240067|NCT00990769|"     The purpose of this study is to determine whether depth of anesthesia has an effect on     emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric     patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of     anesthesia on EA has not been studied. The study will randomize 40 children undergoing     ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or     deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of     Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a     scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.   "
240068|NCT00990782|"     This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a     patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus     has not been established.   "
240069|NCT00990795|"     Administration of cyclosporine has been found to have a myocardial protective effect,     improving post-operative cardiac function in patients undergoing percutaneous coronary     interventions by diminishing infarct size. The purpose of the proposed study is to conduct a     randomized, controlled clinical trial in patients undergoing isolated valvular heart surgery,     or coronary artery bypass surgery. Specifically the investigators will evaluate the     cardio-protective effects of cyclosporine on post ischemic-arrest myocardium. The two factors     will be treatment group and cyclosporine versus placebo.   "
240070|NCT00990808|"     This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with     dyslipidemia already on statin therapy.   "
240071|NCT00990821|"     This 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two     formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults.     Parts I to IV of this study will examine different doses of MK-0517 as well as two different     formulations of MK-0517 (with and without polysorbate 80). Part V of the study will compare     single doses of intravenous non-PS80 MK-0517 to oral 125-mg capsule of aprepitant. The     primary hypothesis for Part V of the study is that a single intravenous dose of 100-mg or     115-mg MK-0517 is area under the plasma-time curve (AUC) equivalent to that of the 125-mg     oral aprepitant capsule in young healthy participants.   "
240072|NCT00990834|"     The purpose of this study is to investigate the mechanism of statin-related myopathy by     evaluating muscle samples before and after statin exposure.   "
240073|NCT00990847|"     The purpose of this study is to compare the efficacy and safety of nebule procaterol with     nebule salbutamol in the treatment of moderate acute asthma.   "
240241|NCT00993707|"     The purpose of the study is to evaluate the safety of administering repeated doses of CTX-100     (formerly ETX-100) to subjects with smoking-related chronic obstructive pulmonary disease.   "
240242|NCT00993720|"     The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on     insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients     with type 1 diabetes.   "
240074|NCT00990860|"     TACE possibly plays a significant role in contributing to a subgroup of surviving residual     tumor tissue which is characterized by more aggressive biology. This explains the strong     scientific rationale for exploring the role of anti-angiogenic therapy such as sorafenib to     remedy and strengthen the therapeutic efficacy of TACE to combat liver cancers. Sorafenib     plays a prominent auxiliary role by further suppressing the tumor growth and prolonging the     time to recurrence and progression. Performing TACE under sorafenib administration may have     synergic effect on hepatic tumoral lesions.   "
240075|NCT00990873|"     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer     may help doctors identify biomarkers related to cancer. It may also help doctors predict how     patients will respond to treatment.      PURPOSE: This research study is looking at tissue samples from patients with stage I     non-small cell lung cancer enrolled on research study CALGB-140202.   "
240076|NCT00990886|"     The objective of this study is to evaluate the safety and efficacy of extended-release     oxybutynin chloride for the treatment of vasomotor symptoms, also known as hot flashes, in     healthy naturally postmenopausal women. This is a randomized, double-blind, multi-center,     parallel group, placebo-controlled study evaluating the safety and efficacy of     extended-release oxybutynin chloride on hot flashes in healthy naturally postmenopausal     women. Patients will be randomized to extended-release oxybutynin chloride or placebo in a     1:1 ratio. The total duration of the study for each treatment group is approximately 98 days.     Patients will be seen for their Pre-Randomization Visit (Visit 1) fourteen (14) days prior to     randomization and a physical examination, medical history, hot flash history, vital signs and     laboratory tests will be performed. Patients will also have daily diaries dispensed to record     their hot flashes (frequency for each severity). Patients who meet the eligibility criteria     for this study will be randomized at Visit 2. At this visit, patients will have vital signs     taken, adverse events recorded, study medication dispensed, and complete Quality of Life     (QOL) questionnaires. The patient will be instructed to start her study medication beginning     the morning after this visit (defined as Study Day 1). In both treatment groups, patients     will return for follow-up visits between Study Days 8-14 (Visit 3), 22-28 (Visit 4), and     50-56 (Visit 5). The Final Study Visit (Visit 6) will occur between Study Days 78-84.   "
240077|NCT00990899|"     The primary objective is to determine the prevalence of sleep disordered breathing in     children with primary hypertension or pre hypertension. The secondary objectives are to     determine any association factors for children with primary hypertension or prehypertension     to have sleep disordered breathing be it gender, age, body mass index (BMI), family history     (hx) or ethnic group.   "
240078|NCT00991588|"     The purpose of this investigation is to determine the clinical outcome of surgical     reconstruction of complete ruptures to the posterior cruciate ligament (PCL) and     posterolateral structures of the knee joint. The outcome will be determined with validated     and rigorous knee rating systems between 2 and 10 years postoperatively. The results will be     determined by the analysis of subjective and functional factors, sports and occupational     activity levels, a comprehensive physical examination, and a radiographic evaluation. We     hypothesize that the appropriately indicated procedures will effectively restore normal knee     stability and function in patients with isolated or combined injuries to these structures.   "
240079|NCT00991601|"     Patients with tumors in liver or pancreas are randomized to ultrasound (UL)-guided FNAC     biopsies with guidance method or UL-guided FNAC biopsies with free-hand method.   "
240080|NCT00991614|"     The objective of this investigation is to compile clinical experience on the use of the     Evolution® Duodenal Stent (Cook Ireland), a CE marked device intended for the palliative     treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by     malignant neoplasms. It is not the goal to change the usual treatment practice of the     investigator or the center, nor to collect information on uses outside the product's     indications. Patients will be treated as per usual medical practices.   "
240081|NCT00991627|"     The aim of this study is to compare two different therapeutic approaches to blood pressure     reduction: pharmacological vs. non-pharmacological. The setting is that of patients     undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval     compression syndrome, which causes a sudden drop in blood pressure.   "
240082|NCT00991640|"     The investigators developed a program aimed at enhancing primary care physician (PCP) teams'     expertise, self-efficacy and attitudes with respect to obesity management. The investigators     implemented and evaluated this obesity management system based on a preceptorship combined     with a virtual learning community favouring continuous support of family medicine groups     (FMGs, Groupes de Médecine Familiale) by a team of experts in obesity management; significant     improvements regarding their attitudes and perception of self-efficacy were observed     immediately after the preceptorship and maintained after one year. Furthermore, the     investigators observed significant changes in their practice that were maintained one year     later.      The investigators hypothesize that their program combining preceptorships with a virtual     community will improve: (1) management and weight loss of obese/overweight subjects who are     treated by PCPs for hypertension (HTN), type 2 diabetes (DM2) or impaired glucose tolerance     (IGT); and (2) screening and initial management of obesity among unselected patients of PCPs     who practice in FMGs.   "
240083|NCT00991653|"     This study aims to identify and quantify the factors associated with excess weight gain     following treatment for breast cancer. It is believed that breast cancer patients gain more     than 4% of their weight at diagnosis which is likely accompanied by an increase in body fat     and waist circumference. It is further thought that this excess weight and increase in body     fat and waist circumference are associated to tumour characteristics, chemotherapy, menopause     status at diagnosis and the presence of genes related to obesity. It is also thought that     women treated with chemotherapy have higher levels of glucose and insulin.   "
240097|NCT00991835|"     Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute     coronary syndrome. Thus, identification of plaques vulnerable to rupture has become     important. The natural history of individual plaques is unknown and needs to be established.     Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality     for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively     investigate the relationship between the characterization of coronary plaques and     cardiovascular events in a large multicenter study.   "
240084|NCT00991666|"     Several methods have been proposed for the measurement of pulsatile ocular blood flow (POBF).     The pneumatic tonometer, which is commercially available, assesses POBF by measurement of     intraocular pressure (IOP) changes during the cardiac cycle. The investigators have recently     developed a method for the measurement of ocular fundus pulsation, which is based on laser     interferometry. In contrast to the Langham system the method is non-contractile and yields a     high topographic resolution. Moreover, the pneumatic tonometer assesses the ocular pressure     pulse, whereas ocular fundus pulsation is a point measure of the ocular volume pulse. These     two parameters are related by the ocular rigidity, which refers to the mechanical properties     of the eye coats.      Age-related macular degeneration (AMD) is the most common cause of blindness in the     industrialized nations. The mechanisms behind this severe eye disease are, however, still     obscure. It has been hypothesized that alterations in choroidal blood flow and ocular     rigidity may contribute to the development and progression of AMD. However, there is     currently little data to confirm this hypothesis. The present study is an attempt to     investigate choroidal blood flow and ocular rigidity by employing laser interferometric     measurement of fundus pulsation and pneumotonometric measurement of fundus pulsation.   "
240085|NCT00991679|"     The aim of this study is to investigate the expression of CXCL9, CXCL10, CXCL11, and CXCR3 in     the tear film and ocular surface of patients with dry eye syndrome.      Thirty-three patients with dry eye (16 Sjögren's syndrome and 17 non-Sjögren's syndrome     patients) and 15 control subjects were recruited. The concentrations of CXCL9, CXCL10, and     CXCL11 in tears were measured using enzyme-linked immunosorbent assay. The correlation     between chemokine levels and tear film and ocular surface parameters was analyzed. Expression     of CXCL9, CXCL10, CXCL11, and CXCR3 in the conjunctiva was evaluated using     immunohistochemistry. Flow cytometry was performed to count CXCR3+ cells and CXCR3+CD4+ cells     in the conjunctiva.   "
240086|NCT00991692|"     A multisite trial to testing different dosage levels of a systematic form of Pediatric     Constraint-Induced (CI) Therapy called ACQUIREc Therapy. The high dosage treatment involved 6     hours of daily therapy services for 21 days. This was compared to a moderate dosage level of     3 hours of daily therapy services for 21 days. It was hypothesized that children receiving     the higher therapy dosage would have greater and more clinically significant benefits from     ACQUIREc Therapy but that both groups of children would benefit from the therapy services.   "
240087|NCT00991705|"     The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics     of fimasartan.   "
240088|NCT00991718|"     This is an open-label, Phase I, single-center, single-dose administration study to determine     the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and     to determine the routes of excretion and extent of metabolism of GDC-0449 (Part B). Parts A     and B will be conducted sequentially, with ≥ 7 days between dosing the sixth subject in Part     A and dosing the first subject in Part B. In each part, 6 healthy female subjects of     non-childbearing potential, between 18 and 65 years of age (inclusive), will be dosed.   "
240089|NCT00991731|"     The purpose of this research study is to evaluate three different approaches for increasing     physical activity in African American women who are not currently doing enough physical     activity. One approach will teach people about physical activity, in groups, using general     principles (general physical activity program). The second approach will teach people about     physical activity, in groups, using principles from the bible (faith-based physical activity     program). The third approach will teach people about physical activity by giving them written     materials created at the National Institutes of Health (control group). Control groups are     used in research studies to see if the program being studied really does have an effect on     physical activity. At the end of the study, people in the control group will also participate     in either the general physical activity program or the faith-based physical activity program.   "
240090|NCT00991744|"     -  Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with          intrathecal liposomal cytarabine and prednisolone during maintenance therapy will          decrease the CNS relapse rate in high-risk ALL patients.        -  Both acute and long-term toxicity are equal in both treatment arms.   "
240091|NCT00991757|"     The purpose of this open-label extension study is to demonstrate that RWJ-333369 is safe as     long-term add-on treatment of partial onset seizures.   "
240092|NCT00991770|"     The purpose of this study is to assess the feasibility and efficacy of massage therapy for     reducing pre-operative anxiety and post-operative pain among predominantly low income     minority cancer patients undergoing surgical placement of a Port-a-Catheter.   "
240093|NCT00991783|"     The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and     the safety of digoxin.   "
240094|NCT00991796|"     The purpose of this study is to determine the effect on toxicity of the addition of CS 1008     to a platinum based chemotherapy regimen on the progression-free survival (PFS) in subjects     with stage IIIB wet or stage IV NSCLC.   "
240095|NCT00991809|"     The purpose of this study is to follow a person's response to experimental pain after     multiple consecutive exposures to alfentanil or diphenhydramine to see if the person can     tolerate the pain more, less, or the same at the end of the study.   "
240096|NCT00991822|"     Glaucoma is one of the most common causes of blindness in the industrialized nations. For a     long time glaucoma has been defined as a disease in which high intraocular pressure (IOP)     leads to irreversible optic disk damage and concommitant visual field loss. However, recent     investigations show that IOP is not necessarily an adequate measure of clinical severity or a     predictor of clinical progression: about 20% of all eyes with high IOP do not develop visual     field loss and some patients suffering from visual field loss due to optic disk damage have     normal IOP. Hence, factors other than IOP are likely involved in the pathogenesis of     glaucoma. The role of vascular factors in the pathogenesis of glaucoma has recently received     much attention and optic nerve head hypoperfusion may play a critical role in the development     of glaucoma. It may therefore be important for an optimal prevention of visual field defects     in glaucoma that the topical antiglaucoma drugs used do not only reduce IOP but also     stabilize or enhance the perfusion of the optic nerve head.      Therefore, the aim of the present study is to compare the effect of a 3 months treatment with     timolol or dorzolamide in patients with open angle glaucoma on optic disk blood flow.   "
240098|NCT00991848|"     Background and Objectives: Fibromyalgia is a pain syndrome characterized by numerous     manifestations. The objective of this study was to evaluate the effect of the combination of     intravenous lidocaine and amitriptyline on the manifestations of fibromyalgia. Methods: A     prospective, randomized, double-blind, comparative study was conducted. All patient received     25 mg amitriptyline. Patients of group 1 (n = 15) received 125 mL 0.9% saline, and patients     of group 2 (n = 15) received 240 mg lidocaine in 125 mL 0.9% saline once a week for 4 weeks.     Manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on     a verbal numerical scale.   "
240099|NCT00991861|"     The aim of this study is to determine the efficacy, safety and tolerability of either a once     or twice daily topical application of LAS41007 compared to a twice daily application of     LAS106521 in the treatment of actinic keratosis.   "
240100|NCT00991874|"     Five percent of children in the UK are prescribed steroid inhalers to control asthma symptoms     but there is no test to determine whether the dose of steroids is correct. Too much steroid     treatment has potential side effects and too little may lead to asthma attacks. Exhaled     nitric oxide (ENO) is a gas present in everyone's breath and may be a useful meter for     asthma control. In children, ENO can be measured easily and quickly, the results are     available immediately to the doctor or nurse and for these reasons ENO is an attractive     clinical test.      Pioneering studies have used ENO to help clinicians treat asthmatic adults and children and     the results are promising. Breathing tests improved among those where asthma treatment was     guided by ENO and asthma symptoms were slightly less frequent. These studies all used a     single ENO value to increase or reduce treatment and study authors have suggested there     should be a range of ENO values where treatment is neither increased nor reduced; what is not     known is what these ENO values may be. Elevated NO is associated with a number of factors     other than asthma, including allergy and pollen exposure. What is not known is how factors     other than asthma affect ENO measurements over time.      The proposed study will answer two important questions: What values of ENO indicate that     steroid treatment should be increased or reduced? And how much does ENO rise and fall     normally? The investigators will recruit 200 asthmatic and non-asthmatic children. The     investigators will measure ENO on six occasions over a 12-month period. The investigators     will measure factors that may affect ENO other than asthma. For the asthmatic children, the     investigators will also assess asthma control. The investigators' methodology is based on     several years experience with ENO. The investigators' results will allow ENO to be used to     monitor asthma.   "
240101|NCT00991887|"     The investigators hypothesized that radiation therapy could be safely administered acutely     after elbow trauma, and it would decrease the number of patients that would require surgical     excision of heterotopic ossification.   "
240102|NCT00991900|"     Adequate perfusion and oxygenation is essential for the function of the inner retina.     Although this is a well known fact, measurement of oxygen saturation in the eye is still a     delicate and not fully explored task. However, recently a new instrument for the non-invasive     measurement of retinal vessel oxygen saturation has been introduced. Unfortunately, no data     about reproducibility in humans is yet available for this instrument. Consequently, the     current study seeks to evaluate the short term and day to day reproducibility of retinal     vessel oxygenation in healthy volunteers.      20 healthy volunteers will be included and oxygen saturation of retinal vessels will be     determined. The reproducibility of the results will be tested by repeated measurements and     the collected data will be independently analyzed by two observers.   "
240103|NCT00991913|"     Despite recent advances in postoperative delirium research, the proportion of patients with     postoperative delirium is still high ranging between 20-80%. Although postoperative delirium     is a frequent complication and is associated with the need for more inpatient hospital care     and longer length of hospital stay, little is known about risk factors for recovery room     delirium (RRD) occurred in postanaesthesia care unit. The aim of the study was to determine     pre- and intraoperative risk factors for the development of RRD among patients undergoing non     cardiovascular surgery.   "
240104|NCT00991926|"     The beneficial effects on plasma lipids of Orlistat, a selective gastrointestinal lipase     inhibitor, are largely independent of weight loss, and might include differential effects     plasma non-esterified fatty acid (NEFA). Apart from their well-known effects on insulin     resistance pathogenesis, elevated NEFA levels probably play also the most important role at     peripheral levels in the pathogenesis of Growth Hormone (GH) insufficiency in obesity. Aim of     this observational, mono-centre, randomized, simple-blind, cross-over study is to verify if     the short-term treatment with Orlistat may results in decline in NEFA circulating levels when     used in conjunction with low-fat diet and if this effect may restore the endogenous activity     of GH/ Insulin-like growth factor (IGF)-1 axis, in the context of GH regulation of     lipoprotein metabolism, thus adding a further benefit of Orlistat in obesity cross-linked     neuroendocrine and metabolic dearrangement.   "
240105|NCT00991939|"     This study will compare treatment with 3 courses of high-dose dexamethasone versus treatment     with prednisone, for patients recently diagnosed with immune thrombocytopenic purpura (ITP).     The primary hypothesis is that patients treated with high-dose dexamethasone will obtain a     more durable remission than patients treated with prednisone.   "
240106|NCT00991952|"     This randomized phase II trial studies how well giving irinotecan hydrochloride with or     without alvocidib works in treating patients with advanced stomach or gastroesophageal     junction cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as     irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Alvocidib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether     irinotecan hydrochloride is more effective with or without alvocidib.   "
240107|NCT00991965|"     The purpose of this research study is to shorten the treatment time course for patients who     are scheduled for surgery to have a dental implant(s) placed into the upper front part of     their mouths and need to have more bone in their jaws to support the implant.   "
240120|NCT00992134|"     The objective of the study is to demonstrate the safety, tolerability, and activity of     Rituximab-Bendamustine-Cytarabine(R-BAC) regimen in patients with mantle cell lymphoma (MCL)     aged 65 years or more, as well as in younger patients who are not eligible for intensive     regimens including/not including autologous transplantation.   "
240121|NCT00992147|"     Autologous cultured adipocytes (ANTG-adip) is produced by well-established techniques     including cell harvesting from lipoaspirates, expansion of adipose tissue derived stem cells,     and differentiation into pure and immature adipocytes. This was an open-label,     dose-escalation study. Patients are given subcutaneous injection of ANTG-adip and followed     for 12 weeks according to the clinical trial protocol.   "
240122|NCT00992160|"     This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant     15mg/day for treatment of Primary Insomnia in adults outpatients.   "
240108|NCT00991978|"     Breast cancer is the most common cause of cancer death among women. Yearly around 12,500     Dutch women are diagnosed with breast cancer and 3,500 die of this disease. One of the     problems leading to such striking effect refers to late tumor detection due to inadequate     sensitivity of current imaging techniques. Current screening is performed by means of     mammography, consisting of traditional film-screen mammograms of digital mammograms. These     digital mammograms offer digital enhancement to aid interpretation, which is especially     helpful in women with dense breast tissue. Screening mammography is nowadays the single most     effective method of early breast cancer detection. For screening of high risk individuals,     increasingly the magnetic resonance imaging (MRI) technique is emerging. However, none of the     above mentioned techniques has an optimal sensitivity and specificity, leading for instance     to a significant portion of false positive results. The clinical consequence of this error is     that additional tests and procedures are performed in women who may not have cancer. In the     United States, for example, 11% mammograms require additional evaluation; the lesion turns     out to be benign in more than 90% of cases [1].      False-positive readings False positive readings are more common in younger women, both     because the tests are less specific and because breast cancer is less common [2,3]. As a     result, more follow-up procedures, including invasive procedures such as biopsies, will be     done in younger women even though fewer cancers will be found. Furthermore, because breast     cancer screening occurs repeatedly, the risk of a false-positive study is likely to rise with     repeated screening [4].      Emerging adjuncts to mammography include ultrasonography, which is helpful for further     assessment of known areas of interest, and magnetic resonance imaging. Image-guided biopsy -     directed by ultrasonography or stereotactic mammography views - plays a critical role in     histological confirmation of suspected breast cancer.   "
240109|NCT00991991|"     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer     may help doctors identify biomarkers related to cancer.      PURPOSE: This research study is looking at tumor tissue samples from patients with stage I,     stage II, or stage III malignant melanoma.   "
240110|NCT00992004|"     The purpose of this study is to determine the efficacy and the tolerance on 15 days of a     turmeric extract (Arantal®) on pain related to gonarthrosis.   "
240111|NCT00992017|"     Both pregnant women and people infected with HIV are at increased risk of viral infection,     including influenza infection. Pregnant women infected with HIV may be at particular risk of     infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity     of an H1N1 influenza vaccine in pregnant women infected with HIV.   "
240112|NCT00992030|"     Combined modality therapy has then emerged as the standard of care for limited-stage     Hodgkin's lymphoma and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)     chemotherapy that is devoid of alkylating agents and associated with a low potential for     gonadal toxicity and leukemogenesis, is currently considered a gold standard. Nevertheless,     the disadvantage to combine radiotherapy to ABVD is represented by late cardiovascular events     (myocardial dysfunction and coronary or valvular disease), especially when the heart is     within the radiation field; bleomycin pulmonary toxicity also is increased in conjunction     with RT and secondary tumors, in particular in the RT fields. This study aims at treating     patients with limited disease with multiagent chemotherapy alone, without irradiation, and     using radiotherapy only for relapses.   "
240113|NCT00992043|"     Creatine supplementation is capable of improving glucose tolerance in healthy subjects. The     researchers aim to investigate whether this supplement can affect metabolic control in     diabetic patients.   "
240114|NCT00992056|"     Research objectives      The objective of this randomized, placebo-controlled, 2 period crossover clinical trial is to     determine the effects of nebivolol versus metoprolol on ambulatory blood pressure, the blood     pressure response to dietary sodium loading, and renal handling of an acute sodium load in     postmenopausal women with hypertension.      Hypothesis      Nebivolol will result in a blunted response of blood pressure to oral sodium administration     and improved renal handling of an intravenous sodium load in comparison with metoprolol in     hypertensive postmenopausal women.      Research plan      Study design      The study consisted of a randomized crossover trial of the effects on sodium sensitivity and     renal sodium handling of nebivolol versus metoprolol. All study procedures were carried out     under the direct supervision of the Principal Investigator in the outpatient and inpatient     research unit of the University of Miami Division of Clinical Pharmacology.      Primary endpoint      Change in 24-hour mean systolic blood pressure determined by 24-hour ambulatory blood     pressure monitor (ABPM) from the final day of low sodium to the final day of high sodium in     nebivolol versus metoprolol   "
240115|NCT00992069|"     Common treatments for tuberculosis (TB) can interfere with certain antiretroviral (ARV)     medications used to treat HIV. People whose immune systems are weakened by HIV infection are     susceptible to TB, so it is important to find treatments for both that can be given in     combination. This study will test the safety of combining a new medication for TB with an     already approved HIV medication in healthy adults.   "
240116|NCT00992082|"     The purpose of this study is to determine whether local infiltration analgesia is more     effective than intrathecal morphine in reducing postoperative pain in total knee     arthroplasty.   "
240117|NCT00992095|"     The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet     under fasted conditions.   "
240118|NCT00992108|"     Botulinum toxin-A (BTX-A) prevents the release of acetylcholine in presynaptic terminals of     the neuromuscular junction. It has been proposed to be effective in spastic conditions of the     head and neck including oromandibular dystonias, bruxism, and muscular hypertrophy (1,2,3,4).     However, only one randomized, double-blinded, placebo controlled trial has been completed     involving 20 patients demonstrating both objective and subjective improvement in the BTX-A     treated group over those treated with saline at one week, one month, and six months (5).      Currently, in most orofacial pain practices, when the diagnosis of masticatory myofascial     pain in the head region is made, patients are treated with a standard myofascial protocol.     This protocol involves stretching, application of moist heat, spray and stretch, and     lidocaine trigger point injections into the masticatory muscles. This is considered the     standard of care among most orofacial pain practioners.      There have been no randomized, double-blinded, head-to-head trials comparing BTX-A injections     to lidocaine injections in the treatment of masticatory myofacial pain. Moreover, in all     studies, muscles were targeted using surface landmarks with no confirmatory tests to     guarantee the medication was administered to the intended muscle. In previous studies, the     medial and lateral pterygoid muscles, important masticatory muscles that is often hyperactive     in masticatory myofacial pain was not injected due to lack of palpable surface landmarks.     Ultrasound and electromyography (EMG) guidance will help us locate these muscles.      The purpose of this study is to objectively measure functional improvement in patients with     masticatory myofascial pain injected with lidocaine versus BTX-A. A pilot study enrolling 20     patients is proposed. 20 patients will be randomized to receive either BTX-A or lidocaine     injections into the bilateral temporalis, masseter, and medial and lateral pterygoid.     Objective and subjective clinical parameters will be measured. These include pain at rest and     with chewing, maximum non-assisted and assisted mouth opening, protrusive and laterotrusive     jaw movements, subjective efficacy of treatment, and side-effects of treatment. Patients will     be assessed at baseline, one week, one month, and three months after the procedure.   "
240119|NCT00992121|"     This study will determine whether blood tests, tumour imaging and tumour tissue analysis can     reveal effects of drugs that block blood vessel growth (angiogenesis) in patients with renal     cancer.   "
241542|NCT01012934|"     The objective of this study is to investigate the bioequivalence of Mylan's alendronate     sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70     mg) dose administration under fasting conditions.   "
240123|NCT00992173|"     This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane I     131 administered to subjects with high-risk neuroblastoma. Iobenguane I 131 is a drug that     has already been used in many children to treat neuroblastoma, and it is known to shrink some     of the tumors, and cause manageable side effects. When administered intravenously, Iobenguane     I 131 accumulates in the neuroblastoma cancer cells and causes them to die.      In this study the investigators are investigating the use of a new form of Iobenguane I 131     called Ultratrace iobenguane I 131. This form is expected to deliver higher amounts of     radioactive I 131 to the neuroblastoma cells. The primary purpose of the study is to     determine if Ultratrace iobenguane I 131 can be used to successfully treat high-risk     neuroblastoma. The study will also assess the safety of Ultratrace iobenguane I 131 when     given to patients with high-risk neuroblastoma.   "
240124|NCT00992186|"     The purpose of this study is to determine the safety and effectiveness of the study drug     carlumab in participants with metastatic castrate-resistant prostate cancer (cancer of the     gland that makes fluid that aids movement of sperm).   "
240125|NCT00992199|"     Gastric cancer is the leading cause of death from a intestinal tract cancer in China.In most     cases, the high death rate is due to tumor that has spread beyond the gastric cancer at the     time of diagnosis. In China, the standard chemotherapy for the initial treatment of gastric     cancer is a combination of a platinum analogue with 5-Fu.With modern surgical interventions     and contemporary chemotherapy, most patients attain better clinical remission.The majority of     them, however, will eventually have a relapse and die of the disease.      The peritoneal cavity is the principal site of disease in gastric cancer.Although the     intensity of intravenous chemotherapy is limited mainly by myelotoxicity, several active     drugs can be administered directly into the peritoneal cavity. The rationale for     intraperitoneal therapy in gastric cancer is that the peritoneum, the predominant site of     tumor, receives sustained exposure to high concentrations of antitumor agents while normal     tissues, such as the bone marrow, are relatively spared.      The investigators conducted this trial to investigate the efficacy and safety of     intraperitoneal chemotherapy in advanced gastric cancer.   "
240126|NCT00992212|"     This present study, a phase II, open label study will evaluate the immunogenicity,     tolerability and safety of an adjuvanted, inactivated Novel Swine Origin A/H1N1 Monovalent     Subunit Influenza Virus Vaccine in healthy subjects aged 18 years and above. This study will     explore the effect of the previous and concomitant exposure to a seasonal influenza     vaccination to the immunogenicity and safety profile of two different doses of an adjuvanted     H1N1sw vaccine.   "
240127|NCT00992225|"     The primary purpose of this study is to determine the objective response rate (complete and     partial response) for patients who receive LY573636 for metastatic breast cancer.   "
240128|NCT00992238|"     The purpose of this study is to compare the relative bioavailability of Flavoxate     Hydrochloride tablets 100mg manufactured by Paddock Laboratories, Inc., with that of Urispas®     tablets 100mg by SmithKline Beecham Pharmaceuticals under fasting conditions.   "
240129|NCT00992251|"     The objective of this registry is to collect data on patient demographics, medical history,     change in prostate, bone and overall health of the patients receiving androgen ablation     treatment using Eligard. Data collected through this national registry program provides an     opportunity to increase knowledge of efficacy and safety of the long term treatment with     Eligard, provide a platform to better identify patient segments for the therapy with     Eligard®. Furthermore registries are the only tools to accurately capture rare adverse     events.   "
240130|NCT00992264|"     The current study tested the effectiveness of four potentially important tailoring factors     (decisional framework, self-efficacy, navigation autonomy, and proactive outreach) in the     context of an online motivational intervention for smoking cessation. A fifth factor was     originally planned by dropped during intervention development due to confounds with the other     planned factors. Information learned from this study will inform how to best design an online     interventions for smoking cessation. Participants were recruited from a large, regional U.S.     health plan. Using a full factorial design to screen for important main effects and 2-way     interactions, participants were randomized to receive one of 16 different experimental factor     combinations and followed for one year to assess program impact on smokers' use of     empirically-validated cessation treatment and abstinence.   "
240131|NCT00992277|"     This study will:      Evaluate the in vivo histological and molecular effects of treatment with eMatrixCO2 and to     determine the dynamics of their development over time following treatment.      Determine the safety and efficacy of treatment with eMatrixCO2 for use in Aesthetic     dermatological procedures requiring the ablation, vaporization, excision, incision, or     coagulation of soft tissue.   "
240132|NCT00992290|"     This research proposes to find whether the probiotic lactobacillus GG is safe and well     tolerated in patients with minimal hepatic encephalopathy. We also want to get insight into     the mechanisms of action of LGG.   "
240133|NCT00992303|"     RATIONALE: Collecting and storing samples of tissue from patients with cancer to test in the     laboratory may help the study of cancer in the future.      PURPOSE: This research study is collecting tissue samples from patients with cancer     undergoing radiation therapy.   "
240134|NCT00992316|"     The purpose of the study is to investigate the safety, toleration and pharmacokinetics of     single oral doses of PF-04531083 in healthy male subjects.   "
240135|NCT00992329|"     The purpose of this research is to see if certain tablet formulation factors affect oral drug     absorption. Medications taken by mouth, such as tablets, need to be absorbed into the body in     order to do any good. Tablets contain a drug, but also contain non-drug ingredients that are     called excipients or fillers. Excipients in the tablet, and the way in which the tablet is     manufactured, both can impact how much drug is absorbed into the body. That is, tablet     formulation factors can cause a tablet to be effective or not effective.      Tablets in this research contain the drug ciprofloxacin hydrochloride. Ciprofloxacin is an     antibiotic to treat infections, such as lung infections. This drug is being used since it has     low water solubility and is probably sensitive to tablet formulation factors.   "
240136|NCT00992342|"     The purpose of this study is to investigate safety and toleration of multiple oral doses as     well as the time course of PF-03893787 concentration in the blood following dosing by oral     solution.   "
240137|NCT00992355|"     This randomized controlled trial compares two regimens of topical therapy:        -  tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day        -  combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four          times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three          times/day. The topical treatment is administered for 28 days after phacoemulsification.      Patients are independently assessed by two ophthalmologists. On day 28, patients are     evaluated for        -  corneal edema        -  conjunctival redness        -  anterior chamber reaction. Moreover, the cases necessitating continuation of treatment          are compared in the two groups on day 28 and 42.   "
240138|NCT00992368|"     Several works show breast hypertrophy as pain cause, postural alterations, dermatitis and     decrease of the functional capacity and of the self-esteem. The economical evaluations are     destined to esteem the costs in alternative ways of attendance to the health, comparing, for     instance, clinical strategies with surgical strategies.      OBJECTIVE: To analyze cost-effectiveness in reduction mammaplasty.   "
240139|NCT00992381|"     The purpose of this study is to determine whether the absorption of naproxen from the PN 400     combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets     (Naprosyn®), which are currently sold in Australia.   "
240140|NCT00992394|"     This study proposes to compare 2 different methods for managing a subject with psoriasis who     has achieved good disease control, as defined by a clinical response with a Physician Global     Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment.      The first method involves stopping etanercept treatment on entry into the study, with the     option to reinitiate etanercept at 50 mg once weekly after medical review and agreement     between the subject and the investigator. The second method involves continuing on etanercept     at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical     review and agreement between the subject and the investigator. Subjects will be randomized     into one of these two study arms.   "
240141|NCT00992407|"     The purpose of this study is to evaluate the efficacy and safety of long acting injectable     (LAI) risperidone and oral risperidone treatment on participants with schizophrenia     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often     with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder     (a mixed psychiatric disorder relating to a complex psychotic state that has features of both     schizophrenia and a mood disorder such as bipolar disorder).   "
240142|NCT00992420|"     This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The     purpose of this study is to assess which genes influence residual platelet reactivity on     standard dose clopidogrel therapy, and also to determine whether certain genes influence the     incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in     patients who have high residual platelet reactivity on standard dosing.   "
240143|NCT00992433|"     The purpose of this study is to see how the body reacts to different strengths of the H1N1     flu shot in persons infected with human immunodeficiency virus (HIV). This study will also     compare how the CD4 count (cells that help fight disease) affects the body's response to the     H1N1 flu shot. In this study, 2 strengths of the H1N1 flu shot will be given twice, about 3     weeks apart. The results of this study will help researchers find out if the different     strengths of the H1N1 flu shot make the body produce H1N1 antibodies that are better at     fighting H1N1 flu. About 240 HIV positive subjects, ages 18-64 years, will be asked to take     part in this study. Study procedures include: blood sampling, physical exams, and use of     memory aids to record temperature, medications and symptoms. The length of patient     participation is about 7 months.   "
240144|NCT00992446|"     This phase II trial studies the side effects and how well bortezomib and vorinostat work in     treating patients with non-Hodgkin lymphoma (NHL) after patients' own stem cell (autologous)     transplant. Bortezomib and vorinostat in the laboratory may stop the growth of lymphoma cells     and make them more likely to die by blocking some of the enzymes needed for cell growth.     Giving bortezomib together with vorinostat after an autologous stem cell transplant may thus     kill lymphoma cells that remain after transplant.   "
240145|NCT00992459|"     This was a randomized, active-controlled, double-blind, cross-over study designed to enroll     subjects with UCDs who are being treated with NaPBA.   "
240146|NCT00992472|"     The purpose of this study is to compare prochlorperazine plasma concentrations produced after     administration of the test formulation with those produced after administration of a marketed     reference product.   "
240147|NCT00992485|"     Up to date, a sure cure for Crohn's fistula has not known and the fistula recurrence rate is     high. On 15 October 2008, orphan drug designation was granted by Korea FDA to Anterogen Co.     Ltd., for human adipose-derived stem cell. In this study, patients are given injection of     ADIPOPLUS in fistula site and followed for 8 weeks to test the safety and efficacy.   "
240148|NCT00992498|"     A retrospective analysis on a cohort of unselected COPD patients admitted to pulmonary     rehabilitation (PR) performed in one rehabilitation centre has shown that the usual program     is feasible and effective even in the presence of complex comorbidities, although some     combined diseases might reduce the overall proportion of patients who respond to pre-defined     outcomes criteria (Crisafulli E, et al. Thorax 2008;63:487-92).      The aim of this prospective study is to describe the pattern of prevalence of the most     frequently associated COPD-comorbidities and the clinical impact on rehabilitation outcomes,     referred to 3 teaching and 1 private hospitals admitting for pulmonary rehabilitation     purposes.   "
240149|NCT00992511|"     The objective of this study is to evaluate the immunogenicity and safety of one or two doses     of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two     different processes, in adults aged 18 to 60 years.   "
240150|NCT00992524|"     The purpose of this study is to compare effectiveness and safety of an oral titrated solution     of misoprostol with vaginal misoprostol for induction of labour with an alive fetus.   "
240151|NCT00992537|"     This trial is conducted in Europe. The aim of this clinical trial is to compare the blood     glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250     (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where     the trial participant will receive one single dose of each trial product in varying order.   "
240152|NCT00992550|"     The aim of this study is to compare exposure to tobacco smoke toxins in individuals who smoke     both cigarettes and Hookah pipes. Sixteen subjects will be hospitalized on the research ward     for two visits of 4 days each. At one visit they will smoke their usual cigarettes in     approximately normal frequency, and at the other visit they will smoke Hookah at least twice     per day. The order of the visits will be randomized. On the fourth day of each visit (when     nicotine, carbon monoxide (CO), and some carcinogen levels will be in a steady state     condition), circadian blood and urine and expired air samples will be collected.   "
240153|NCT00992563|"     The purpose of this study is to evaluate the safety, tolerability, and effects of     investigational drug AL-39324 for the treatment of wet AMD.   "
240154|NCT00992576|"     The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an     improved bowel function for constipated pain patients.   "
240155|NCT00992589|"     The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an     inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with     placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to     11 months of age.   "
240156|NCT00992602|"     This phase II trial studies how well giving liposomal cytarabine and high-dose methotrexate     works in treating patients with breast cancer that has spread to the central nervous system.     Drugs used in chemotherapy, such as liposomal cytarabine and methotrexate, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving liposomal cytarabine with high-dose methotrexate may kill more tumor cells.   "
240157|NCT00992615|"     The optimal number of prostate cores extracted during a prostate biopsy performed because of     a suspected prostate cancer is still debated. The present consensus is to sample 12 cores.     However, recent data published in the literature brought arguments in favour of a higher     number, probably 20. This would have the advantages of decreasing the false negatives and the     re-biopsy rate.   "
240158|NCT00992628|"     Patients undergoing surgery or intensive care management often require a tube to be inserted     into the trachea allowing lung ventilation. Usually a laryngoscope is used to allow     visualisation of the larynx and facilitate intubation.      During direct laryngoscopy, the blade of the laryngoscope is inserted into the patient's     mouth and the structures pulled upwards out of the line of vision. If visualisation is     difficult, users often exert excess force on the tissues to obtain an adequate view.     Generally the applied force is evaluated by the patient's stress response such as increased     heart rate, blood pressure or plasma cortisol levels. These changes, while important, may be     confounded by a variety of patient factors, as well as anaesthesia. An increased force may     also be associated with tissue trauma, dental damage, and prolonged attempts.      The investigators' objective is to compare the force exerted on patient's tissues by the     Macintosh laryngoscope and GlideScope video-laryngoscope. Video-laryngoscopes may be     associated with the application of reduced force to the soft tissues of patients during     intubation. While this is a common contention, it has not been proven. The GlideScope has a     micro camera in the distal portion of the blade meaning a direct line of vision is not     required. An adequate view can therefore be obtained with less displacement of tongue tissue.     If the force exerted by the video laryngoscope is less, this would have beneficial     implications by reducing stress response, neck movement, and trauma.   "
240159|NCT00992641|"     SYSDIET (Systems biology in controlled dietary interventions and cohort studies) is one of     the three centres in the NCoE Food, Nutrition and Health, 2007-2011. It consists of 12     partners from five Nordic countries working on multidisciplinary fields of science related to     nutritional biology. The main objective of SYSDIET is to reveal mechanisms by which Nordic     foods and diets could be modified to promote health and prevent insulin resistance, type 2     diabetes and cardiovascular diseases, all of which being connected to metabolic syndrome.     Furthermore, the aim is to build up a Nordic platform for cohort studies and carefully     conducted multi-centre dietary intervention studies, where novel nutritional systems biology     tools can be applied besides human studies also in animal and cell culture studies. In order     to achieve the main objective a Nordic multi-centre randomized controlled human intervention     study is being conducted in 2009-2010 in 6-8 centres of SYSDIET consortium.      Health of the Nordic populations has substantially improved during the last 30 years. This is     due e.g. to marked decline in cardiovascular morbidity and mortality. However, during the     last 10-20 years increasing obesity and sedentary lifestyle have resulted in an increase of     metabolic syndrome and type 2 diabetes.      Having this background, the aim of the SYSDIET consortium is to carry out a controlled,     randomized dietary intervention study in persons with features of metabolic syndrome to find     out the effects of a healthy Nordic food on major abnormalities in metabolic syndrome.      Altogether 167 persons aged 30 to 65 years were recruited from 6-8 centers (40-60     subjects/center) of the SYSDIET cohort. The main inclusion criterion is BMI 27-38 kg/m2. The     subjects should also have at least two other IDF criteria for metabolic syndrome. Recruited     persons will start the study by following their conventional diet for one month as a run-in     period. After that subjects will be randomly assigned into Experimental- or     Control-diet-group for 6 months. Experimental diet is rich in whole grain products, berries,     fruits, vegetables and fish, and its fat intake is modified according to current Nordic     recommendations. Control diet is based on the current information of the mean dietary intake     and food consumption. The diets will be realized according to eating habits in each Nordic     country.   "
240160|NCT00992654|"     The new protocol will allow the patients enrolled on A4001050 to have continuous access of     Maraviroc and the treatment will not be interrupted until the drug is commercially available     in India.   "
240161|NCT00992667|"     The aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive oxygen     species) and NOS (reactive nitrogen species) synthesis in 10 nonsmoking mild asthmatics.     Effects of nebulized apocynin (0.5 mg/ml, 6 ml) are assessed in exhaled breath condensate     (EBC) after 30, 60 and 120 minutes.   "
240162|NCT00992680|"     The purpose of this study is to evaluate the safety and preliminary performance of the ROX     Anastomotic Coupler System (ACS), with standard of care (as defined per GOLD) in patients     with Chronic Obstructive Pulmonary Disease (COPD) as compared to standard of care alone.   "
240163|NCT00992693|"     This is a Phase 2 study of the safety and efficacy of Intravenous (IV) Ribavirin in treating     patients presenting with a probable or suspected case of viral hemorrhagic fever (either     Crimean Congo or Lassa Fever) at a military medical treatment hospital. All patients will be     treated with a 10 day course of IV Ribavirin if they meet all the inclusion and none of the     exclusion criteria.   "
240164|NCT00992706|"     RATIONALE: F511 cream may prevent or reduce palmar-plantar erythrodysesthesia in women     receiving doxorubicin hydrochloride liposome for metastatic breast cancer.      PURPOSE: This randomized phase III trial is studying F511 cream to see how well it works     compared with a placebo cream in preventing palmar-plantar erythrodysesthesia in patients     receiving doxorubicin hydrochloride liposome for metastatic breast cancer.   "
240165|NCT00992719|"     The purpose of this study is to evaluate the safety of a 2009 H1N1 influenza vaccine in     pregnant women and to determine how their body reacts to different strengths of the vaccine.     Two strengths of the H1N1 influenza vaccine will be tested. Since it is not known if the     response to the vaccine in pregnant women is the same or different than in non-pregnant     women, the study also includes a group of women who are not pregnant for comparison.     Participants include 200 pregnant women and 100 non-pregnant women ages 18-39. Study     procedures include physical exams, several blood samples and maintaining a memory aid to     document daily temperature and side effects for 8 days following vaccination. Participants     will be involved in study related procedures for about 6 months.   "
240166|NCT00992732|"     The purpose of this study is to determine if treatment with HQK-1004 and valganciclovir will     result in complete or partial responses in patients with EBV-positive lymphoid malignancies     or lymphoproliferative disorders.   "
240167|NCT00992745|"     This is an open-label study comparing the imaging characteristics of 123-I-MIP-1072 and     ProstaScint® (111-In-capromab pendetide)in patients with metastatic prostate cancer. Eligible     patients will receive a dose of 123-I-MIP-1072 and have imaging studies and safety     assessments (physical examination, vital signs, electrocardiogram, clinical laboratory tests)     performed during the subsequent 24 hours. Two weeks later, patients will return for     additional safety assessments and will receive ProstaScint® if they don't already have a     pre-existing ProstaScint scan. Final assessments will be performed two weeks after the     ProstaScint® scan unless there is a difference between the 123-I-MIP-1072 and ProstaScint®     scans. If this is the case, another dose of 123-I-MIP-1072 will be given 12 weeks later, and     imaging studies repeated.   "
240168|NCT00992758|"     This is a phase I, dose escalation, open-label, multicenter study of iodine-131 Anti-B1     Antibody for patients with non-Hodgkin's lymphoma (NHL) who have more than 25% bone marrow     involvement with NHL. Prior studies with Iodine-131 Anti B1 Antibody for the treatment of NHL     have excluded patients with more than 25% bone marrow involvement with NHL. To be eligible,     patients must have been previously treated and failed to achieve an objective response on or     relapse during or following their last treatment.      Patients will undergo two dosing phases while on study. In the first phase, termed the     dosimetric dose, patients will receive 450 mg unlabeled Anti-B1 Antibody infused over 1     hour or longer followed by 35 mg of Anti-B1 Antibody of which 1-2 mg has been labeled with 5     mCi of Iodine-131 infused over 20 minutes. Whole body camera scans will be obtained on Day 0,     Day 2, 3, or 4, and Day 6 or 7 following the dosimetric dose. Using dosimetric data from     three imaging time points, a patient-specific dose of Iodine-131 Anti-B1 Antibody to deliver     the desired total body dose of radiotherapy will be calculated. In the second phase, termed     the therapeutic dose, 450 mg Anti-B1 Antibody will be infused over 1 hour or longer     followed by 35 mg of Anti-B1 Antibody labeled with the subject-specific dose of Iodine-131 to     deliver the desired total body radiation, infused over 20 minutes. The dose escalation will     be initiated at 45 cGy and will be increased in 10 cGy increments until the maximum tolerated     dose (MTD) is reached.      Patients will be treated with either saturated potassium iodide, Lugol's solution, or     potassium iodide tablets starting at least 24 hours prior to the infusion of the dosimetric     dose and continuing for 14 days following the last infusion of the therapeutic dose.      The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti B-1     Antibody in patients with previously treated NHL having more than 25% bone marrow involvement     with lymphoma. Secondary endpoints include assessment of response rate, duration of response,     relapse-free survival, time to treatment failure, safety, and survival.   "
240169|NCT00992771|"     Spinocerebellar ataxia (SCA) is a group of inherited disorders characterized by cerebellar     degeneration leading to imbalance, incoordination, speech difficulties and problems with     walking. Recently, individual case reports have suggested that varenicline, a drug used in     smoking cessation, produces substantial improvement in patients with several inherited     ataxias. A modest response was noted in 5 patients with SCA, suggesting that it is     potentially efficacious in this disorder as well. Although this agent is available for     off-label use, the severe side effects noted with its use and the lack of long-term toxicity     data demand that it be systematically assessed. The present study will test whether     varenicline is safe and potentially efficacious in a heterogeneous cohort of adults with SCA.   "
240170|NCT00992784|"     The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine.     Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the     same vaccine for the third time. For this study the masking is observer-blind for elderly     subjects and open for young adult subjects.   "
240171|NCT00992797|"     The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of     vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main     hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from     supplementation with cholecalciferol in sufficient doses to optimize serum levels.   "
240172|NCT00992810|"     The ultrasound guided supraclavicular block is a peripheral nerve block which is considered     safe, has a fast onset, is dense and provides complete block of the nerves supplying the     hand, forearm and arm. However retrospective studies done at Toronto Western Hospital have     highlighted the fact that most commonly the ulnar nerve fibres (responsible for sensations in     the ring finger, little finger and the corresponding part of hand), sometimes escape this     block and need additional supplementary block at a distal peripheral nerve site. It is a     confusing fact since all nerve fibres are compactly arranged in a sheath at the     supraclavicular level. The local anaesthetic agent at this level should be equally     distributed among all nerve fibres. The purpose of this study is to compare two different     approaches (medial and lateral) adopted by our clinicians to perform this block and to test     the effectiveness of each approach for successful ulnar nerve fibre blockade.   "
240173|NCT00992823|"     Aim: To evaluate the efficacy of iron supplements given at intervals corresponding to the     mean life of red blood cells compared to weekly supplementation, in reducing the prevalence     of preschool anemia.      Method: Ninety-nine children from public day care centers with ages from 24 to 59 months old     were randomly divided into two groups. All the children received 40 doses of 30 mg of ferrous     sulfate during a 10-month intervention period. Group 1 received once weekly supplementation     and Group 2 received supplementation in two 5-month cycles, each cycle consisting of one     month of supplementation (20 workdays) and four months without supplementation.   "
240174|NCT00992836|"     Children and people infected with HIV are particularly susceptible to influenza infections.     This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus     in children and youth infected with HIV.   "
240175|NCT00992849|"     The purpose of the current study is to assess the efficacy and safety of the inhibitory     effect of bevacizumab (Avastin) with different routes including topical and subconjunctival     application on corneal neovascularization in the human eyes.   "
240176|NCT00992862|"     The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg     tablets (by Paddock Laboratories, Inc.) with that of Univasc® 15mg tablets (by Schwarz     Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under     fasting conditions.   "
240177|NCT00992875|"     Training in mindfulness, the non-judgmental observation of experiences as they arise in the     present moment, has been increasingly and successfully applied to the treatment of normative     stress conditions and mental disorders. Yet, the neurological mechanisms that underlie the     reported improvements are still largely unknown. This longitudinal study will investigate the     influence of mindfulness training on a key underpinning of mental health, namely emotion     regulation, and its associated brain activity. Healthy participants will be randomly assigned     to either a validated eight week Mindfulness-based stress reduction (MBSR) program or to a     control condition. In a pre-post investigation, participants' subjective reactions to     aversive emotional stimuli (affective facial expressions) will be assessed, as will the     associated brain activation using functional magnetic resonance imaging (fMRI). The     investigators hypothesize that after the training the MBSR participants will rate the     pictures as less aversive compared to control participants. Furthermore, the MBSR     participants will show a patter of brain activation indicative of improved emotion     regulation, relative to control participants. Finally, the effect of MBSR on the gray matter     structure of the brain will be investigated.   "
240178|NCT00992888|"     The purpose of this study is to investigate the role of endotoxins and the endotoxin mediated     immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect     of Liver assist (liver dialyses) intervention on these parameters in patients with severe     alcoholic hepatitis.   "
240179|NCT00992901|"     RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM)     immediately after surgery before any significant weight loss. In addition, a growing number     of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several     years following their surgery. While the mechanisms by which RYGB improves glucose metabolism     or alters islet cell function in patients after RYGB are not understood, recent studies     suggest that increased secretion of GI hormones, primarily glucagon-like peptide 1 (GLP-1),     as well as alteration in neural activity may contribute to enhanced insulin secretion in     general, and to a greater extent in patients with hypoglycemia. The proposed research is     designed to address the role of RYGB on insulin secretion by evaluating the contribution of     stimulatory factors (neural and GI hormone) on islet cell function and the islet cell     responsiveness to the physiologic stimulatory factors, in RYGB patients with and without     hypoglycemia and non-operated controls.   "
240180|NCT00992914|"     This study is being done to determine whether stellate ganglion injection with local     anesthetic (the study procedure) can reduce the number and severity of hot flashes in women     who have hot flashes.      Hot flashes can have a significant impact on daily living, disrupt sleep, and lead to fatigue     and irritability during the day. Hot flashes are the most common reason that women seek     hormonal therapy. However, for many women, including breast cancer survivors, this is rarely     an option, and these women seek alternatives to hormonal therapy to treat hot flashes.      The study procedure has been in clinical use for more than fifty years in treating certain     disease states and chronic pain. The study procedure has not been used to relieve hot flashes     and the use of the study procedure with local anesthetic for the reduction of hot flushes is     considered experimental.   "
240181|NCT00992927|"     The purpose of the study is to compare the efficacy of intra-articular hydraulic distension     (IHD) for the treatment of painful stiff shoulders between capsule-rupturing and     capsule-preserving IHDs.   "
240182|NCT00992940|"     Awake craniotomy for removal of brain tumour is performed because the tumour may be located     close to areas of the brain that control specific functions such as movement or speech. Local     anaesthesia (freezing) and sedation are required to make the patient comfortable and free of     pain, but also to be able to cooperate for testing of brain function (speaking, moving) in     order to preserve these areas while removing the brain tumour. The patient will be     administered routine anesthetic drugs (sedatives (propofol) and pain killers (remifentanil)).     The amount of sedation and analgesia (pain killer) is individually tailored to each patient     as each person has different requirements. The usual way to give these medications is by the     anesthesiologist assessing pain level, watching the patient and monitoring blood pressure and     heart rate. Another way to give this medication is now available. This is with a special     device, known as a patient-controlled analgesia pump (PCA). This device allows the patient to     push a button to give pain medicine through an intravenous line and is frequently used for     pain treatment after surgery and for other types of procedures. This device may be helpful     during awake craniotomy, as it would allow patient-controlled administration of pain medicine     and relaxing medicine whenever required. The amount of medication can be increased by more     presses of the pump. At all times during the operation, the anesthesiologist will monitor the     patient.   "
240183|NCT00992953|"     It is proposed that using Virtual Reality as part of therapy will result in improvements in     Post Traumatic Stress Disorder for Service Members with PTSD related to service in Iraq     and/or Afghanistan.   "
240184|NCT00992966|"     The VRI device may provide a complementary diagnostic tool for lung examination and aid the     physician in determining whether a chest x-ray should be performed.   "
240185|NCT00992979|"     In Canada, Addiction Prevention and Treatment Service's (APTS) offer programs specifically     designed to help people withdrawal from psychoactive drugs. While participants of withdrawal     management (Detox) programs generally reach their goals, the process is a difficult one often     exacting an emotional and physical toll. Troublesome symptoms of withdrawal from psychoactive     drugs may include anxiety and sleep disturbances. If untreated these symptoms can lead to     discontinuation of withdrawal and /or affect the introduction of cognitive-behavioral and or     motivational therapy components of Detox programs. In Detox the symptoms of withdraw are     managed pharmacologically. Pharmacological tools for managing anxiety and sleep disturbances     exist and while effective and safe, in many clinical settings, have limitations and liability     in the addiction treatment setting. To address these concerns APTS has incorporated     non-pharmacological anxiety management practices into its programs. Prominent among these is     therapeutic massage (chair massage in the Swedish tradition). While therapeutic massage has     been shown to reduce state and trait anxiety in a variety of clinical settings, no previous     study has assessed its anxiolytic or sleep promoting efficacy in an addiction treatment     setting. In keeping with ATPS's policy on evidence-based practice, evidence in support of     this practice is now required.      Research Objectives: We propose to test the Hypothesis: Therapeutic Massage is an effective     therapy for managing withdrawal-related anxiety and for improving sleep effectiveness in     patients withdrawing from psychoactive drugs. Our specific objective is to perform a     randomized controlled trial (RCT) to determine whether therapeutic massage is effective in     comparison to relaxation control treatment in reducing the levels of state and trait anxiety     associated with withdrawal and in promoting sleep efficiency.      Research Design: A RCT of the effects of therapeutic massage will be conducted on 80 patients     (ages 18-65) attending an APTS Detox program. Patients will be assigned to 1 of 2 treatment     groups (n=40/group) and will receive either: therapeutic massage or relaxation control     treatment once a day for 3 consecutive days. Anxiety, state and trait, will be measured pre     and post each treatment through a standardized tool and physiologic measures (heart rate &     blood pre(state and trait) and sleep efficiency will be determined through actigraphy and     daily sleep logs.   "
240186|NCT00992992|"     The primary efficacy endpoint of this study is to determine the duration of response of the     sequential administration of Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP for     patients with previously untreated Mantle Cell Lymphoma (MCL). The secondary efficacy     endpoints for this study are to determine the response rate, confirmed response rate,     complete response rate, confirmed complete response rate, duration of response for confirmed     responders, duration of response for complete responders, duration of response for confirmed     complete responders, progression-free survival, time to treatment failure, and the predictive     value of detection of minimal residual disease by molecular techniques on response duration.     The pharmacokinetic endpoint is to determine the total body residence time of Iodine-131     Anti-B1 Antibody following the dosimetric dose. The safety endpoints are to determine the     incidence of adverse experiences, hematologic toxicity, (e.g., nadir, time to nadir, and time     to recovery), use of supportive care, percent of patients converting to human anti-murine     antibody (HAMA) positivity, the effects of Iodine-131 Anti-B1 Antibody on the growth and     function of hematopoietic progenitor cells, and survival of patients with previously     untreated MCL treated with Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP.   "
240187|NCT00993005|"     The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort)     usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind     placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons     to be recruited and randomized for the study is 90.   "
240188|NCT00993018|"     The purpose of this study is to evaluate the analgesic efficacy, safety and tolerability of     multiple doses of JNJ-42160443 when administered as a single, subcutaneous injection every 28     days to patients with diabetic painful neuropathy (a disease condition in diabetic patients     that affects all peripheral nerves including pain fibers, motor neurons and the autonomic     nervous system).   "
240189|NCT00993031|"     This study is an open-label, single site, randomized controlled trial comparing protease     inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected     pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria. The study is     designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will     have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART     regimen. The primary study endpoint of the study is placental malaria. This study also     enrolls the infants of these women at the time of delivery.   "
240190|NCT00993044|"     This phase I study is designed to determine the maximum tolerated dose of Irinotecan given     intravenous for 5 days every 3 weeks in combination with fixed doses of Vincristine,     Temozolomide and Bevacizumab (VIT-B) in patients with refractory solid tumors.   "
240191|NCT00993057|"     What is the efficacy and safety of q 30 minutes vs. q 1hour glucose sampling and intervention     for an intensive insulin protocol to achieve and maintain euglycemia in non-diabetic patients     undergoing craniotomy? The investigators hypothesize that in non-diabetic patients undergoing     craniotomy, monitoring glucose and modifying insulin infusions every 30 minutes compared to     every hour will help them reach target glucose levels faster and maintain them more     efficiently with the same insulin protocol.   "
240192|NCT00993070|"     Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical     capsaicin has been used to treat the pain, but there is no data in lower concentration. This     is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic     polyneuropathy.   "
240193|NCT00993083|"     This is a Phase IIa open label, non placebo controlled, non-randomised controlled challenge     study. The primary objective of this study is to assess the safety of a new influenza     vaccine, MVA-NP+M1, when administered as a single dose to healthy volunteers.      Initially two volunteers will be vaccinated and challenged with Influenza, followed by     vaccination of a further 12 volunteers and an Influenza challenge of those 12 along with 12     non-vaccinated controls.   "
240194|NCT00993096|"     This trial was conducted in Europe. The aim of this clinical trial was to evaluate the     pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at     three therapeutically relevant doses in subjects with type 1 diabetes.      The trial is designed as a four period, incomplete block cross-over trial where the trial     participant will be randomised to a treatment sequence by which the subject will receive two     matched dose levels of NN5401 and biphasic insulin aspart, respectively.   "
240195|NCT00993109|"     This will be a multi-center, prospective, randomized, open-label, parallel design, two arm     comparator trial. In the proposed study, the investigators will compare low-dose combination     therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with     respect to their blood pressure-decreasing effects in patients with essential     hypertension.The study consists of a screening visit, followed by randomization and     administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or     Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP     and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.   "
240196|NCT00993122|"     The results of antiviral therapy in patients with recurrent hepatitis C after liver     transplantation are lower than standard. Ribavirin has immune-modulating effects and seems to     be crucial to optimize viral treatment. The aim of this multicenter controlled study is to     examine the effect of Ribavirin pre-treatment preceding the combination therapy with     peginterferon plus ribavirin on the sustained virological response.   "
240197|NCT00993135|"     RATIONALE: Gathering information about how often kidney dysfunction occurs in children and     young adults receiving methotrexate for acute lymphoblastic leukemia may help doctors learn     more about the disease and plan the best treatment.      PURPOSE: This research study is looking at kidney dysfunction in children and young adults     who have received low-dose or intermediate-dose methotrexate for acute lymphoblastic     leukemia.   "
240198|NCT00993148|"     The objective of this study is to evaluate the safety and efficacy of a novel combination     antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in     treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in     treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy     with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.   "
243263|NCT01039870|"     This study aims to evaluate the effect of the paravertebral block using a multi-lumen     catheter on the incidence and severity of acute and chronic postthoracotomy pain compared to     the thoracic epidural block.   "
240199|NCT00993161|"     The aim of this study is to evaluate different devices to quantify upper limb function     (Motriplate) and strength (Myogrip, Myopinch) in non-ambulatory patients with neuromuscular     disorder. Motriplate measures the ability of the patient to reproduce a repetitive movement     of the wrist to push two 5cm*5cm targets during 30 seconds. One hundred patients aged 8-30     years and 60 controls will be evaluated during twelve months (M0, M6 and M12) with theses new     tools, and results will be compared to other testing, such as wrist, grip and pinch strength,     taping, MFM measurement, and self evaluation of hand ability.   "
240200|NCT00993174|"     Adult patients requiring surgery for esotropia will be randomized to surgery under topical     anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic     procedures will be compared. Motor and sensory outcome of the two treatment groups will also     be compared.   "
240201|NCT00993187|"     This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®),     MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary     hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior     reduction in HbA1c (mean change from baseline) compared to glimepiride.   "
240202|NCT00993200|"     Warfarin is the most commonly used oral anticoagulant medicine (blood thinner). Although this     medicine works well, it is difficult to know how much medicine a patient needs. Many things     affect how much medicine a patient needs and doses can be very different from patient to     patient. It is important for patients to get the right dose to prevent clotting or bleeding     problems that can happen with this medicine if the dose is too low or too high. These     problems can be life-threatening. To help find the right dose, patients on warfarin must have     frequent blood tests to measure how well the medicine is working. The investigators know     differences in people's genes can affect how much warfarin medicine someone needs, but they     don't yet know with certainty how to use this information in making patient care decisions.     The hypothesis of this study is that using a patients warfarin related genetic information     incorporated into a computer algorithm to be used by a warfarin provider will lead to better     warfarin management compared to usual care.   "
240203|NCT00993213|"     Liposuction surgery is common, yet animal and limited human data suggest that fat returns     when removed. This study was designed as a 1-year randomized-controlled trial of suction     lipectomy versus no intervention to determine if adipose tissue is defended, and if so to     determine the anatomic pattern of redistribution.   "
240204|NCT00993226|"     The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain     control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and     safety evaluations. The study duration consists of a screening period up to 14 days and a     treatment period 14 days with a long term follow up visit at 6 months. The study will provide     further data on the efficacy and safety of the product.   "
240205|NCT00993239|"     A Phase 1 open-label, non-randomized dose escalation study to determine the maximum tolerated     dose (MTD) and characterize the safety and tolerability of Birinapant (TL32711).   "
240206|NCT00993252|"     Each year, Canadian emergency department physicians treat 600,000 patients with head injury.     Many of these are adults with minor head injury, i.e. loss of consciousness or amnesia and     a Glasgow Coma Scale (GCS) score of 13-15. Only 6.2% of these minor patients have some     acute injury on computed tomography (CT scan) and only 0.5% have an epidural hematoma     requiring surgery. Among Canadian teaching hospital emergency departments, we have shown a     fourfold variation in use of CT and that a small but important number of intracranial     hematomas are missed at the first visit.   "
240207|NCT00993265|"     Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with     trichotillomania can experience significant impairment due to peer teasing, avoidance of     activities (such as swimming and socializing), difficulty concentrating on school work and     medical complications due to pulling behaviors. Despite the fact that trichotillomania has a     childhood onset, no randomized, controlled trials have been completed in childhood     trichotillomania.      Research in adults with trichotillomania has demonstrated that most commonly currently     prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake     inhibitors) is ineffective in treating this condition. By contrast, randomized controlled     trials in adults have suggested the efficacy of N-acetylcysteine as well as behavioral     treatments such as Habit Reversal Therapy.      The goal of this trial is to determine the efficacy of N-Acetylcysteine for pediatric     trichotillomania. N-Acetylcysteine is a glutamate modulating agent, with a fairly benign     side-effect profile.   "
240208|NCT00993278|"     The purpose of this research is to assess the effects of a low-carbohydrate (modified Atkins)     diet versus a low fat (Heart Healthy) diet on cardiovascular health.   "
240209|NCT00993291|"     In this study the investigators will evaluate the effect of both low and high frequency Deep     Brain stimulation of the subthalamic nucleus (STN) in Parkinson's patients who have noted a     change in their walking. The investigators' hypothesis is:        1. Stimulation at 60 Hertz (Hz) is associated with improved gait with increased stride          length and faster time on the Stand walk sit test.        2. There is no worsening of the Unified Parkinson's Disease Rating Scale (UPDRS) at 60 Hz.   "
240210|NCT00993304|"     This trial is conducted in Europe. The aim of this trial is to investigate whether a new     compound, liraglutide, reduces the level of lipids (fat), including cholesterol, in the blood     of type 2 diabetics, following a meal with high fat content.   "
240211|NCT00993317|"     The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in     combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in     patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.   "
240224|NCT00993486|"     The purpose of this study is to determine the maximum tolerated dose and evaluate the safety     of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem     cell transplant from a related, haploidentical donor, in patients with severe hematologic     malignancies.   "
240225|NCT00993499|"     The primary objective of this trial is to identify the Maximum Tolerated Dose of BIBW 2992     therapy when given continuously in combination with Sirolimus.      The MTD will be based on the Dose Limiting Toxicity information collected during the first     two cycles.      Overall safety, pharmacokinetics and anti-tumour efficacy will be evaluated as secondary     objectives.   "
240212|NCT00993330|"     The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein     and zeaxanthin, which are contained in vegetables and fruits. The highest concentrations of     lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the     MP before reaching the photo receptors it absorbs a significant portion of short-wavelength     light. There is evidence that these absorbing properties of the MP as well as the ability of     inactivating highly reactive oxygen species are protective for the retina.      Measurement of macular pigment is difficult and the investigators have recently proposed a     way of measuring macular pigment optical density (MPOD) based on optical reflectometry. There     is increased interest in these measurements in the recent years, because a number of studies     has provided evidence that low fruit and vegetable consumption increases the risk of age     related macular degeneration (AMD). The present study investigates MP optical density (OD) in     healthy volunteers and is used to form a database.      Furthermore the nutritional habits and the influence on MP density will be evaluated.   "
240213|NCT00993343|"     To evaluate if rapamune + tacrolimus immunosuppressive prophylaxis is better than the     established therapy using cyclosporine and methotrexate, a Nordic prospective multicenter     randomized study will be performed. Patients will be randomized to treatment with rapamune     combined with tacrolimus, or the established therapy using cyclosporine and methotrexate.   "
240214|NCT00993356|"     Previous studies addressing preoperative somatostatin analogs (SSA) treatment and subsequent     surgical cure rates are conflicting, reporting a benefit, or no difference between groups.     And most reported studies were rather small and were made in retrospect, we conducted a     prospective, randomized study to investigate whether 4-month preoperative lanreotide     treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with     macroadenomas. The investigators also aimed to investigate whether there were differences in     the incidence of surgical complications, and duration of neurosurgical hospital stay.   "
240215|NCT00993369|"     This is a proof of principle study that investigates heart rate variability differences in     fetal and neonatal life in a longitudinal study design and compares two subject groups,     offspring conceived using in-vitro fertilization and conceived naturally.   "
240216|NCT00993382|"     The Primary objective was to assess the efficacy of Celivarone for the prevention of     Implantable Cardioverter Defibrillator (ICD) interventions or death.      Secondary objectives were:        -  To assess the tolerability and safety of the different dose regimens of Celivarone in          the selected population.        -  To document Celivarone plasma levels during the study.   "
240217|NCT00993395|"     Substance-using adults are admitted to hospital for medical complication from their drug and     alcohol use at very high rates; yet, their care is often defined by low rates of referral to     addiction treatment programs and recidivism. In 1997, we instituted an integrated     medical-substance use treatment program at Johns Hopkins, the First Step Day Hospital,     designed for intensive post-acute care of previously hospitalized substance using adults. We     have shown that patients with dual diagnoses admitted to First Step more often complete their     course of medical care and stay in recovery longer than patients not admitted to First     Step.(1;2) On discharge from First Step, patients are medically stable and drug-free. Their     substance abuse care is transferred to an out-patient substance abuse treatment facility and     their medical care is transferred to their primary care provider. Unfortunately, many     patients are lost to follow-up during this transition. We believe that a peer mentor-based     disease management program (PM) can provide continuity of care that begins in First Step and     continues after discharge thereby increasing the proportion of patients who remain in     treatment for their addiction and medical conditions. Peer mentors are persons from the     target community who have been in recovery for 5 or more years. In cooperation with patients     and providers, peer mentors improve the integration of care, quality of care, and access to     healthcare services. This pilot study will test the effectiveness of a peer mentor-based     disease management program. The specific aims are to compare the impact of the PM     intervention verses enhanced usual care on outcomes in three domains (1) medical/psychiatric     health status, (2) addiction recovery, and (3) social resource acquisition. If successful,     this study will provide evidence supporting a larger randomized controlled trial of the     impact of field workers on post-acute care among patients with dual diagnoses.   "
240218|NCT00993408|"     This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study     followed by randomized, double-blind, parallel-group, placebo controlled study. Eligible     subjects will undergo an open-label, single-dose acute hemodynamic study with     ACT-293987(NS-304) and 21 weeks of double-blind treatment during which subjects will receive     either ACT-293987 (NS-304) or placebo b.i.d. Subjects who have completed the double-blind     study can enter the open extension study (separate protocol) and receive administration of     ACT-293987 (NS-304) if the subject wishes and the Investigator considers it appropriate.   "
240219|NCT00993421|"     The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604     or sibutramine alone in the treatment of obesity.   "
240220|NCT00993434|"     The purpose of the research is to learn whether written materials or handouts that are given     to parents are helpful in changing knowledge or behavior.   "
240221|NCT00993447|"     Primary objectives:        -  To describe the immune response to each dengue serotype before and after each          vaccination with sanofi pasteur's CYD dengue vaccine.        -  To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.   "
240222|NCT00993460|"     Research has shown that fat stored within muscles affects the muscle's sensitivity to insulin     and ability to handle blood glucose. The purpose of this study is to examine the effects of     weight loss surgery-induced caloric restriction on the accumulation and types of fats within     skeletal muscle, as well as the effects of such caloric restriction on insulin sensitivity     and inflammatory responses in skeletal muscle. The investigator proposes that caloric     restriction will result in decreases in diacylglycerols enriched with saturated fat and     increases in diacylglycerols enriched with monounsaturated fats.   "
240223|NCT00993473|"     The primary study objective was to compare the rate of all hypoglycemia (composite outcome     of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous     glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG),     low FSBG readings performed at other times) between children treated with Lantus (insulin     glargine) and Neutral Protamine Hagedorn (NPH) insulin.      Secondary objectives were to compare insulin glargine and NPH in terms of:        -  rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal          symptomatic, and severe nocturnal symptomatic hypoglycemia        -  HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment        -  percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment        -  average blood glucose over whole trial and at end of trial, as estimated by continuous          glucose monitoring (CGM), and blood glucose variability   "
243264|NCT01039883|"     The purpose of this study is to determine whether albaconazole tablets and albaconazole     capsules (single 400mg dose) act in the body in the same way over a period of time.   "
240228|NCT00993538|"     The main objective of this project is not only a better understanding of the human leukemic     disease but also to find new anti-leukemic or improve existing ones. This study has, the     following aims:        -  To analyze the genetic and epigenetic regulation of the retinoic acid induced cascade          which leads to the expression of TRAIL in blood cells of patients with acute leukemia.          This study will be complemented by the analysis of global gene expression (DNA chips)          and of the DNA methylation state, and by chromatin immunoprecipitation experiences.        -  To determine the efficiency of inhibitors of enzymes responsible for the modification of          chromatin (existing and new developments within the European consortium EPITRON          coordinated by Dr Gronemeyer) as inducers of differentiation and / or apoptosis of          leukemic blasts.        -  To explore Ikaros genic and functional abnormalities (genomic deletions, mutations,          abnormal transcripts and proteins) in acute leukemia. The aim is to determine if these          abnormalities may play a prognosis role.   "
240229|NCT00993551|"     This trial is a randomised controlled trial with a parallel design taking place in centres     across the UK, Scandinavia and Brazil.      650 infants with a diagnosis of isolated cleft palate who are considered medically fit for     operation at 6 months, and who meet the inclusion criteria, will be included in the trial and     randomised to receive either:        -  Surgery at age 6 months, OR        -  Surgery at age 12 months.      The main objective is to determine whether surgery for cleft palate, using a specified     technique, at age 6 months, when compared to surgery using the same technique age 12 months,     improves speech development. All infants will be followed up at age 12 months, 3 years and     five years for the assessment of the primary outcomes(age 5) and secondary outcomes.   "
240230|NCT00993564|"     The investigators will determine if the MRI can be used to determine the temperature inside     the brain. This is an important piece of information now that cooling the brain is being used     to decrease brain damage in infants who had a decrease in brain oxygen or flow around the     time of birth.   "
240231|NCT00993577|"     To compare the efficacy of global postural reeducation (GPR) with static stretching exercises     (SS) in the treatment of women with temporomandibular disorders (TMD).      Physical therapy is of importance in the treatment of myogenic temporomandibular disorders     (TMD). Both stretching exercise and global posture reeducation are equally effective in the     treatment of TMD.   "
240232|NCT00993590|"     The primary aims are to test whether an asthma care management system (M-CHESS) delivered via     a smartphone (cellular phone with internet access) can support low income teenagers (ages     12-18) with significant asthma and can improve asthma control and reduce asthma-related     emergency or urgent care visits and hospitalizations. Secondary aims include whether M-CHESS     increases adherence to asthma control medication and reduces absenteeism from school, work or     an event they wanted to attend.   "
240233|NCT00993603|"     The aim of this study is to investigate weather gradual weight loss achieved with healthy     lifestyle changes influence hormonal factors affecting appetite and blood glucose control in     obese people without presence of diabetes.   "
240234|NCT00993616|"     This phase II trial is studying how well giving belinostat together with carboplatin works in     treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube     cancer, or primary peritoneal cancer that did not respond to carboplatin or cisplatin.     Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving belinostat together with carboplatin may kill     more tumor cells.   "
240235|NCT00993629|"     This study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone     administered adjunctively to treatment as usual in PTSD and depression in OEF/OIF Veterans.   "
240236|NCT00993642|"     The long-term objective of this research is to understand the molecular mechanisms of     acquired endocrine resistance in breast cancer. Identifying these mechanisms is critical to     the implementation of novel therapeutic strategies that can target and overcome altered gene     networks involved in controlling breast cancer progression. While patients with tumors over     expressing HER1, 2, or 3 have been shown to have reduced survival, patients with those tumors     which overexpressed HER4 (erbB4) had increased survival (Witton 2003).      This is a non-randomized, single-arm, proof of principle trial. Selected are patients with     advanced-stage breast cancer whose tumors are ER+, tamoxifen refractory. Histologically     proven diagnosis of recurrent or metastatic breast cancer is advanced cancer for which there     is no treatment available which would have a reasonable chance of cure. Treatment failure is     defined as tumor progression after chemotherapy and tamoxifen therapy. Patients will be given     five 30mg doses of HDAC inhibitor (LBH) over a period of two weeks. A dose will be taken on     Days 1,3,5,8 and 10. Patients will have a diagnostic tumor biopsy prior to drug     administration and a diagnostic biopsy within 48 hours (2 days) of the last dose. Primary     endpoints are measured by biopsy of palpable tumor with immunohistochemical staining for     ERBB4. Secondary end points include the evaluation of cell death, apoptosis, with     immunohistochemical staining for DNA breaks by TUNEL assay.   "
240237|NCT00993655|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving     them in different ways may kill more tumor cells. It is not yet known which combination     chemotherapy regimen is more effective in treating patients with ovarian epithelial cancer,     primary peritoneal cancer, and fallopian tube cancer.      PURPOSE: This randomized phase II trial is comparing the side effects of three combination     chemotherapy regimens and to see how well they work in treating patients with stage IIB,     stage IIC, stage III, or stage IV ovarian epithelial cancer, primary peritoneal cancer, or     fallopian tube cancer.   "
240238|NCT00993668|"     The purpose of this trial is to assess the affect of Certolizumab Pegol (CZP) treatment on     antibody response to T cell-independent and T cell-dependent immunizations using pneumococcal     and influenza vaccines, respectively.   "
240239|NCT00993681|"     The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine     System to actively immunize against Enterotoxigenic Escherichia coli disease in a field     setting.   "
243265|NCT01039896|"     The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.   "
240243|NCT00993733|"     The prevalence of acute renal failure in intensive care is estimated at between 5 and 20%     depending on diagnostic criteria retained. And half of patients require the use of     hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis     technique widely used in intensive care unit.      The CVVHDF is performed at the bedside, by a mobile generator with a semi permeable membrane,     a blood circuit, a dialysate circuit and a feedback circuit.      The implementation of a CVVHDF requires the use of large amounts of biological liquid     essential to enable the purification of blood during its passage through the artificial     kidney.      The objective of this study is to assess time nursing work and the costs of each method.   "
240244|NCT00993746|"     Will the technique of adding lidocaine to bupivacaine fasten the onset of bupivacaine alone     for infraclavicular brachial plexus block in end-stage renal disease (ESRD) patient?   "
240245|NCT00993759|"     The purpose of this of this study is to determine if 3804-250A can prevent the common cold     caused by the rhinovirus when applied to the hands. The study will also evaluate whether     3804-250A can prevent rhinovirus infection or common cold illnesses.      The study will also evaluate the safety of 3804-250A.   "
240246|NCT00993785|"     To evaluate product performance and safety of the Catheter Design for the treatment of a     single coronary lesion.   "
240247|NCT00993798|"     The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain     control in patients undergoing elective arthroscopic shoulder surgery on the basis of     pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening     period up to 14 days and a treatment period 14 days with a long term follow up visit at 6     months. The study will provide further data on safety.   "
240248|NCT00993811|"     The purpose of this study is to evaluate the Shang Ring, a novel Chinese device for voluntary     medical male circumcision, in order to improve the provision of male circumcision services     for HIV prevention in Africa.   "
240249|NCT00993824|"     The purpose of this study is to obtain continuous glucose monitoring (CGM) data from     individuals taking Welchol compared to placebo. The CGM data will determine the effect on     glucose control of adding Welchol to an anti-diabetic medication regimen.   "
240250|NCT00993837|"     Endoscopic thyroidectomy has been used to treat thyroid diseases in China. However, whether     this technique is rational to treat thyroid carcinoma is still in controversy. The diagnosis     of thyroid carcinoma is predominantly made according to intra-operative frozen section     pathological examination in China. In this research, the investigators want to compare     clinical index (blood loss, operation duration, number of lymph nodes dissected, complication     rates, etc) between patients underwent endoscopic thyroidectomy ( total thyroidectomy) and     those underwent conversion to open procedure. The investigators want to evaluate the     technical feasibility of endoscopic thyroidectomy for treating thyroid carcinoma.   "
240251|NCT00993850|"     The study aims to evaluate a psychological intervention for individuals who suffer from sleep     disturbance and bipolar disorder. We are hoping that this treatment will: (1) improve the     quality of life of individuals with bipolar disorder who are suffering from sleep disturbance     and (2) reduce the risk of, or help prevent, episodes.   "
240252|NCT00993863|"     The objective of this study is to evaluate the analgesic efficacy and safety of ADL5859     compared with placebo and an active control (ibuprofen) in subjects with acute dental pain     after third molar extraction.   "
240253|NCT00993876|"     Cognitive deficits in major depression seem explicable by the well-recognized concept of     impaired neuroplasticity in mood disorders. This concept initially emerged from preclinical     evidence that antidepressants phosphorylate and therefore activate the cyclic AMP response     element binding protein (CREB) that is essential for synaptic plasticity. Nevertheless, the     question remains whether the activation of CREB by antidepressants is relevant for the     remission of cognitive deficits in patients. We addressed this issue by investigating the     cognitive improvement during treatment with either citalopram or reboxetine because these     antidepressants are different in their capacity to increase phosphorylated CREB (pCREB).     Besides the pharmacological treatment groups, another group of patients was treated     exclusively with psychotherapy.   "
240255|NCT00993902|"     Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more     than one dominant follicles (>16mm).   "
240256|NCT00993915|"     In which CHD patients with high risk of CV complications are different doses of LIPRIMAR     used? For this purpose, data on hyperlipidemia will be elicited over and above the basic     nosographic and demographic data, concomitant diseases and cardiovascular risk factor.   "
240257|NCT00993928|"     RATIONALE: Following a program that uses written materials and pre-recorded mp3 devices may     help improve the sleep of cancer survivors. It is not yet known which home-based program is     more effective in improving the sleep of cancer survivors.      PURPOSE: This randomized phase II trial is comparing two home-based programs for improving     sleep in cancer survivors.   "
240258|NCT00993941|"     The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow     mesenchymal stem cells (BMSCs) transplantation via portal vein in patients with early and     middle stage of liver cirrhosis on the basis of HBV infection. The evaluation of the efficacy     includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST),     total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ),     collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1     week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also     observed simultaneously.   "
240268|NCT00999921|"     The purpose of the study is to determine the efficacy and relapse rate of low dose, short     duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with     respect to etiology and estrogen receptor status and to realize its side-effects and cost of     therapy.      To do a comparative analysis of the results with evening primrose oil which is one of the     first line management in benign breast disease.   "
240269|NCT00999934|"     The purpose of eye movements is to ensure clear, optimal vision. In order to see clearly,     images must be held steady on the retina. Best visual acuity is achieved when the image of     the object of interest is brought to and held on the fovea of the retina. Two main types of     eye movements are responsible for that: those that keep images stable on the retina (gaze     holding mechanisms) and those that change the line of sight (gaze shifting mechanisms).     Several functional classes of eye movements have been defined; each has distinctive     physiological properties that suit best to its particular task. Thus, vestibular and     optokinetic eye movements hold images of the seen world steady on the retina during     perturbations of the head. Saccades are rapid eye movements that bring the image of an object     of interest, detected in the periphery of vision, onto the fovea where it can be seen best.     Smooth pursuit eye movements place the images of a moving target close to fovea. Vergence eye     movements place the images of a single object simultaneously onto both foveae.      Each functional class of eye movements relies on a different neural substrate. The clinical     significance of it is that impairment of a specific class of eye movement points to     involvement of distinct structures or pathways within the brain. Thus, abnormalities of     ocular motility are often the clue to the anatomical localization of neurological disorders.      Significance: This study will contribute to understand how the brain governs production of     eye movements, and provide better insight on interaction between sensory (visual) and motor     (eye movement) system, i.e. sensory-motor interaction. It will also contribute to identify     pathophysiological mechanisms underlying human diseases and will improve the investigators'     ability to diagnose and encourage development of new therapeutic strategies.      Methods: The investigators will measure eye and head movements using the magnetic scleral     search coil technique. The magnetic search coil technique is the most sensitive and accurate     technique used in modern ocular motor and vestibular research for measuring horizontal,     vertical and torsional eye movements. The coils are easy to apply and well tolerated over a     wearing period of up to 45 minutes per recording session.      Population: A grand total of about 250 individuals (normal subjects and patients) will be     recruited for the study. Patients will be recruited from the in- and out-patients of the     Neurology and Neuro-ophthalmology services of Meir Medical Center. Healthy normal subjects     will be recruited from faculty and staff of Meir Medical Center.      Criteria for inclusion/exclusion: The investigators will study patients with neurological     disorders causing abnormal eye movements: Degenerative CNS diseases, extrapyramidal     disorders, Spino-cerebellar ataxias, Cerebrovascular diseases, demyelinating diseases, Ocular     motor and vestibular palsies, Mitochondrial and other ocular myopathies. Only patients who     are medically stable and are able to give informed consent will be included in the study.     Criteria for excluding subjects will include eye disease such as corneal or scleral abrasion     or disease, glaucoma, refractive errors greater than 2 diopters and concurrent medication     with CNS-active agents.   "
240319|NCT01002144|"     Background: Increased serum high sensitivity C-reactive protein (hs-CRP) has been associated     with airway inflammation in asthma and may serve as a surrogate marker for the presence of     airway hyper-responsiveness (AHR) in this set-up. This study was designed to evaluate the     predictive value of hs-CRP for AHR assessed by metacholine challenge test (MCT), in adults     with suspected Asthma.   "
240259|NCT00993954|"     Radial head subluxation, also known as pulled elbow or nursemaid's elbow, is one of the most     common upper extremity injuries in young children and a common reason for an emergency     department visit.1 The injury typically occurs when a forceful longitudinal traction is     applied to an extended and pronated forearm.2 Children with radial head subluxation are     usually easily recognized by their clinical presentation and rapidly treated by a simple     reduction technique involving either hyperpronation or supination and flexion of the injured     arm.3-7      Despite the relative ease of diagnosis and treatment, children with radial head subluxation     often wait several hours in a pediatric emergency department for a reduction that takes only     a few minutes.8 Such visits have direct health care costs and involve time and stress for the     child and their family. While many factors are associated with parental and patient     satisfaction in the emergency department, it appears that that early treatment or     intervention and shorter waiting times correlate with patient and parent satisfaction.9,10 As     well, patient satisfaction appears to be the same or better when emergency department care     for minor injuries is provided by nurse practitioners compared to physicians.11-13     Increasingly nurse initiated treatments and the use of medical directives and clinical     pathways are becoming a focus in providing health care.14-17 While radial head subluxation     treatment is an appropriate area to consider management by emergency department nurses, no     studies have examined their role in the management of this common injury. Our study's     objective was to examine whether triage nurses, trained in the use of a medical directive     that taught recognition and treatment of radial head subluxation, could successfully reduce     radial head subluxation at a rate similar to physicians. Given the practical constraints at     the time of emergency department triage, this study was designed as a cluster randomized     trial where the unit of randomization was a day and the patients on any given day were     assigned to the nurse or physician arm for the entire day.   "
240260|NCT00993967|"     This is an Extension study of the MICONOS main randomised placebo-controlled trial     (NCT00905268), and open to those patients completing the main study. The scientific aim of     this extension study is to monitor safety and tolerability of idebenone over two years in     patients with Friedreich's Ataxia.   "
240261|NCT00993980|"     The purpose of this study is to assess the effectiveness of qigong for the treatment of low     back pain compared to a stabilizing exercise therapy.   "
240262|NCT00993993|"     The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P)     is multidisciplinary. The careful consideration of concerned families during the repetitive     appointments required by these treatments show the importance of the psychological context     and of the harmonious structuring of the parents-child relationships on the child's     development. Yet the birth of a child affected by CL/P is a particularly stressing and     traumatising event for the parents. The investigators' prospective, multidisciplinary and     multi-centred research project aims to assess the psychological perceptions of parents of     children affected by CL/P over the year following the birth and analyse the child's degree of     psychological suffering as well as the parents-child relationships. The time of the first     surgical intervention varies amongst the treatment centres. The investigators listed four     centres that intervene at different times according to the more or less long waiting times     between the child's birth and this first surgical intervention. The results obtained for each     group will be compared to one another and according to two sub-groups: parents who found out     about the CL/P through embryo diagnosis and those who found out at their child's birth. The     mental and psychological dimension due to the malformation and its correction will be     analysed in the parents group (importance of the prenatal diagnosis, relational development     with the child, self-esteem, quality of life) but also in the child (likely distress and     withdrawal symptoms).   "
240263|NCT00994006|"     The magnesium food content in the Western world is consistently reducing. Hypomagnesemia is     common in hospitalized patients, especially in the elderly with coronary artery disease (CAD)     and/or those with chronic heart failure. Hypomagnesemia is associated with increased     incidence of diabetes mellitus, metabolic syndrome, mortality rate from coronary artery     disease (CAD) and all cause. Magnesium supplementation improves myocardial metabolism,     inhibits calcium accumulation and myocardial cell death; it improves vascular tone,     peripheral vascular resistance, afterload and cardiac output, reduces cardiac arrhythmias and     improves lipid metabolism. Magnesium also reduces vulnerability to oxygen-derived free     radicals, improves human endothelial function and inhibits platelet function, including     platelet aggregation and adhesion. The data regarding the absorption difference between     supplemental magnesium oxide and magnesium citrate in humans is spare.   "
240264|NCT00994019|"     Recently human papillomavirus (HPV) has been recognized to cause some oropharyngeal (tonsil)     cancer. But very little is known about oral HPV infection and risk factors. This study will     evaluate how common oral HPV infection is, what sexual behaviors are associated with risk for     infection, and how long infections tend to last.   "
240265|NCT00994032|"     The purpose of this study is to determine whether percutaneous vertebroplasty is able to     improve long-term quality of life in patients with pain secondary to osteoporotic vertebral     fractures, compared to conventional medical treatment.   "
240266|NCT00994045|"     Thoracoabdominal aneurysm (TAAA) repair is a major elective vascular operation associated     with a large blood loss and potentially life-threatening clotting abnormalities. Theses     clotting abnormalities are principally treated using fresh frozen plasma (FFP) (derived from     human blood donations), the administration of which carries a number of risks including virus     transmission (human immunodeficiency virus (HIV), hepatitis B, hepatitis C) and infection     with variant Creutzfeld-Jacob disease (vCJD). FFP is no longer administered to children or     high-usage adults in the UK because of the infection risk, and recently it was decided by a     UK advisory body that the use of UK-derived FFP should cease.      Fibrinogen concentrate is an alternative treatment option to FFP which is thought have less     infection risk (purified, heat treated) and has been in licensed use for many years in other     European countries. The investigators have been using fibrinogen concentrate recently in     their department as an alternative to FFP with encouraging results.      20 patients undergoing elective TAAA repair at The Royal Infirmary of Edinburgh will be     randomly allocated to receive standard treatment (FFP) or fibrinogen concentrate as treatment     for clotting abnormalities during their surgery. The investigators will take a number of     additional blood samples which will provide valuable information about the pattern of     clotting abnormalities during this type of operation. The investigators will also record     blood loss and the number of allogeneic (derived from human donors) blood components     transfused to the patient (red cells, FFP and platelets). Our primary objective is to assess     the pattern of coagulation abnormalities in both groups. We will also examine whether the use     of fibrinogen concentrate during TAAA repair avoids the need to administer FFP.   "
240267|NCT00999908|"     This study compared the effects of a single dose of indacaterol with that of a single dose of     tiotropium on inspiratory capacity.   "
240270|NCT00999947|"     The purpose of this trial is to study the genetic and phenotypic aspects of Arrhythmogenic     Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C), and determine the impact of genetic     testing in clinical practice.   "
240272|NCT00999973|"     In this study 126 eyes in 63 patients with moderate bilateral myopia and astigmatism between     -3 and -5 (SE difference between two eyes should not be more than 0.75 and the residual     corneal thickness>350 μ ) were entered in the study. One eye went randomly under PRK with     mitomycin C 0.02% in 15 min and then the other eye went under the operation without MMC.     UCVA,BCVA, refractory error after the operation and the number of endothelial cells before     and after the surgery would be compared in 6 months.   "
240273|NCT00999986|"     Condylomata acuminata (CA) caused by human papillomavirus (HPV) is a common sexually     transmitted disease with half a million new cases diagnosed in the United States per year.     Recurrence is a major challenge for CA treatment. The investigators have demonstrated that     FOXP3+ regulatory T (Treg) cells mediate the immunosuppression in large genital warts. And     low-dose cyclophosphamide (CY), a conventional chemotherapy drug, has been reported to     selectively deplete Treg cells in cancer patients. Therefore, the investigators hypothesized     that low-dose CY can be used to treat genital warts. In this study, 104 CA patients have been     recruited for clinical trial with a 1:2 randomization. Among them, 64 patients received     low-dose cyclophosphamide and 32 received placebo. In 8 extra patients, high-dose     cyclophosphamide was given.   "
240274|NCT00999999|"     Main objective of this trial is to assess the hypothesis whether the application of TachoSil®     as a dural sealant improves the quality of craniotomy procedure and outcome in general     compared with standard dural closure techniques in a controlled and randomized way. As a     primary endpoint the investigators look at possible postoperative occurrence of CSF pads or     leakages needing any kind of intervention until day 30 after the primary craniotomy.     Furthermore, the investigators will look at other surgery-related complications and at     pharmacoeconomic endpoints such as hospital stay or cost of the implant. Overall, the results     of this study will provide important information on whether or not the adjunct of a     relatively expensive implant on a routinely basis for the closure of elective craniotomies is     safe and effective, or not.      To date, TachoSil® is often used in neurosurgery and other surgical disciplines in a     non-standardized fashion also to prevent CSF leakage after dural closure. So far, adverse     events directly related to the product have not been reported. Theoretically, any implant may     be associated with a higher incidence of postoperative infections (e.g. epidural, subdural or     subgaleal empyema). On the other hand, it is not known whether or not the application of     TachoSil® on the dural suture may reduce CSF leakage.   "
240275|NCT01000012|"     To provide access of the Becker Expander/Breast implant to women who do not meet     inclusion/exclusion criteria of the Becker Continued Access Study      Patients' physician will contact Mentor to request use of the device and each request will be     reviewed by Mentor, an IRB, and the FDA on a case-by-case basis   "
240276|NCT01000025|"     RATIONALE: PF-00299804 may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It is not yet known whether PF-00299804 is more effective than a     placebo in treating patients with advanced non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying PF-00299804 to see how well it works     compared with a placebo in treating patients with stage IIIB or stage IV non-small cell lung     cancer that has not responded to standard therapy for advanced or metastatic cancer.   "
240277|NCT01000038|"     Purpose of the study: Falls in Alzheimer's Disease (AD) are common and lead to fractures,     acute hospitalizations and increased rate of institutionalization. Poor balance and gait     abnormalities, commonly associated with AD, are risk factors for falls. Improving balance and     gait abnormalities is critical to prevent falls in AD.      Exercise interventions improve gait and balance in elderly. Walking is the most commonly     recommended home-based exercise program for elderly by primary care providers. However, it is     difficult to engage patients with AD in long term exercise programs. Barriers to exercise     programs include lack of motivation, poor engagement, and external factors such as the cost     of physical therapy (PT). Use of readily available technology might bridge this gap by     providing high level of engagement via use of multimedia at an affordable price.      Wii-Fit is a Nintendo gaming console used for aerobics, strength training, and balance     activities. This device includes a balance board that senses weight, movement and balance.     Wii-Fit is a TV based self-directed activity not limited by the constraint of a therapist's     presence. Virtual trainers talk the user through the activity while tracking progress.     Furthermore, visual and auditory feedback improves engagement. Some skilled nursing     facilities have started using the Wii-Fit as an adjunct to PT, and note improvement in     balance along with social benefits but no systematic studies are done to generalize the     findings.      The investigators propose an 8 week prospective randomized study with the treatment group     receiving the exercise program delivered by Wii-Fit system and the comparison arm receiving a     walking exercise program.   "
240278|NCT01000051|"     The goal of this clinical research study is to learn if eltrombopag can help to improve     platelet counts in patients with low platelets after they have had a stem cell transplant.     The safety of this drug will also be studied.   "
240279|NCT01000064|"     The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can     help with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently     approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this     drug may have on attention deficits caused by TBI are not known, but we expect that Vyvanse     will be of some help in treating those types of problems as well. The study will utilize     functional magnetic resonance imaging (fMRI) methods, as well as neurobehavioral measures, to     elucidate neural mechanisms of response.   "
240280|NCT01000077|"     The purpose of this study is to establish viable cell culture system techniques for a variety     of healthy and diseased tissues for use in future in vitro and in vivo research studies in     tissue engineering.   "
240281|NCT01000090|"     Evaluate biochemical differences in acromegalic patients treated with surgery versus     somatostatin analogues (SMS) (after surgery or alone).      Hypothesis: Treatment modality exhibit different biochemical responses in acromegaly.   "
240303|NCT01001936|"     The purpose of this study is to evaluate the safety and tolerability of oral SKI-606 (100,     200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant     solid tumors and to define a maximum tolerated dose (MTD) in this subject population. This     study will also obtain preliminary information on the pharmacokinetics and antitumor activity     of orally administered SKI-606 in subjects with advanced malignant solid tumors   "
240282|NCT01000103|"     Visuospatial neglect is a common neurological symptom which appears following strokes on     regions of the right hemisphere of the brain. It affects patient's self representation and     awareness of the space, impairing functional rehabilitation and adaptation back to a normal     life. The primary purpose of this protocol is to assess the impact of 10 daily sessions of a     non-invasive brain stimulation technique, low frequency repetitive Transcranial Magnetic     Stimulation (rTMS), applied on the intact hemisphere of the brain to treat post stroke     visuospatial neglect at the chronic stage. The hypothesis is that a regime of real but not     sham rTMS on the left posterior parietal cortex of the brain will long-lastingly ameliorate     visuospatial neglect in stroke patients as revealed by clinical paper-and-pencil and     computer-based tests assessing search, detection and discrimination of stimuli presented in     different areas of the visual field.   "
240283|NCT01000116|"     In this study the researchers want to compare fibrin glue versus tacked fixation in fixation     of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the     first 3 days postoperative days. Moreover, the researchers investigate general well-being,     fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are     investigating chronic pain and clinical recurrence.   "
240284|NCT01000129|"     To demonstrate that radiotherapy treatments for bladder cancer can be delivered with greater     accuracy using a new planning method and that this method can be used simply and effectively     by those delivering treatment.   "
240285|NCT01000142|"     This pilot research study will investigate the possible benefit that elderly nursing home     patients may receive from regular Osteopathic Manipulative Medicine (OMM) care during the     winter months. The study is based on the osteopathic philosophies that structure and function     are interrelated and that the body has self-healing mechanisms. The body is expected to have     optimized ability to heal itself when all its parts are in place (AT Still). This study is     looking at subject population for whom their ability to take care of themselves is diminished     by their underlying diseases. Based on the osteopathic philosophies, optimization of the     nursing home patient's physical structure through osteopathic manipulative treatment (OMT)     should enhance their body's homeostatic mechanisms. This study is assessing the validity of     these philosophies by looking at the effect of OMT on the global health of these individuals.   "
240286|NCT01000155|"     Sickle Cell Disease (SCD) is a hereditary anemia that causes the red blood cells to change     their shape from a round and doughnut-like shape to a half-moon/crescent, or sickled shape.     People who have SCD have a different type of hemoglobin (protein that carries oxygen). This     different type of hemoglobin makes the red blood cells change into a crescent shape under     certain conditions. Sickle-shaped cells are a problem because they often get stuck in the     blood vessels blocking the flow of blood and can cause inflammation and injury to important     areas of the body. All babies are born with hemoglobin called fetal hemoglobin (HbF). Soon     after birth, HbF production slows down and another hemoglobin called adult hemoglobin (HbA)     is made. Clinical studies have shown that increasing the amount of HbF in the blood may     prevent sickling of the red blood cells. Vorinostat has been used in the treatment of cancers     and in other research studies and information from those suggests that it may help treat SCD     by increasing the amount of HbF in the blood. The purpose of this research study is to     determine the effectiveness and safety of vorinostat when used to treat SCD.   "
240287|NCT01000168|"     Introduction.        -  There is a demand for evidence whether treadmill therapy is more efficient than          traditional walking training as an intervention for patients with hemiplegia after          cerebral stroke.      Design.        -  A randomized controlled trial.      Material.        -  Stroke patients with moderate to severe functional deficits referred to inpatient          medical rehabilitation.      Method.        -  Comparing a treatment group receiving treadmill training with body weight support with a          treatment group receiving conventional walking training.      Study aim:        -  Investigate whether treadmill therapy is more effective than traditional functional          training in restoring walking and transfer in patients with moderate to severe          ambulatory deficits after stroke.   "
240288|NCT01000181|"     The build up of plaque in the wall of the artery supplying blood to the brain poses a risk of     stroke when the plaques become unstable and fragile. It is important to determine which     patients are most at risk so that surgery can be performed. There is evidence that the risk     is greatest when these plaques become oxygen deficient (hypoxic). The investigators wish to     use PET imaging to identify hypoxic plaque, to help decide whether and when to perform     surgery. The investigators have developed radiotracers (imaging agents) for this purpose, and     this study is to determine whether they will work in patients.   "
240289|NCT01000194|"     The main objective of this study is to elucidate whether different dietary fatty acids (SFA,     PUFA, butter fat and margarine fat) in a high fat load will have different effects on PBMC     gene expression profiles. Secondary objectives are to elucidate the effects of these fat     loads on individual plasma free fatty acid profiles, triglycerides and cholesterol levels.   "
240290|NCT01000207|"     This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule     (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy     children/adolescents based on European Medicines Agency's Committee for Medicinal Products     for Human Use (EMEA/CHMP) criteria, and safety and tolerability.   "
240291|NCT01000220|"     Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible     inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions     the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this     Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need     to take omeprazole due to GI problem are evaluated in two groups including placebo and drug     users. The effect will be finally assessed.   "
240304|NCT01001949|"     The investigational product used in this study is a soft drink containing an     arabinoxylan-oligosaccharide (AXOS) preparation extracted from wheat bran (hereafter called     Wheat Bran Extract, WBE).      The objective of this study is to analyze the effect of the intake of WBE on various     parameters of gastrointestinal health in children (8-12 yrs). Additionally, safety was     analyzed using treatment emergent Adverse Events (AEs).   "
241230|NCT01018277|"     Aim of the present study is twofold.        -  First we want to evaluate the effect of mobilization on acute postoperative pain        -  Second to test weather chances in pain sensitivity are occurring following surgery and          mobilization after total knee arthroplasty   "
240292|NCT01000233|"     Intervention study focused on preventing the progression of aortic valve calcification.      Vascular and cardiac calcifications are a marker of risk and poor outcome, especially the     severe calcified aortic stenosis and coronary calcification.      Its increasing prevalence is now a health problem. The knowledge and the therapeutic     objective of this condition have changed in recent years and pathophysiological aspects at     present, focus on atherosclerotic disease and inflammation.      Several clinical trials have failed to demonstrate that statins or ACE inhibitors prevent the     progression of cardiovascular calcification.      Taking into account the new concepts of ectopic calcification and research results from our     group, the most logical approach to prevent progression would be an early intervention and     management of the calcification inhibiting agents such as phytate (inositol six-phosphate --     InsP6).      Hypothesis: The phytate prevents or delays the progression of cardiovascular calcification.      It is a clinical trial of intervention of oral phytate (InsP6) in patients with mild to     moderate cardiovascular calcification (aortic valve and / or coronary arteries) compared with     placebo over a period of 24 months.      It is a prospective, randomized minimization of variables to ensure homogeneity of the     groups.      The primary analysis will be the time evolution of the extent of calcium in the aortic valve     and coronary arteries made with CT.      Secondary variables are the degree of progression of aortic stenosis and clinical events     (death, stroke, angina, stroke and cancer of any type).   "
240293|NCT01001806|"     Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will     be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects     will be instructed to begin dosing the study medication in the operative eye the day before     surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop     of study medication will be instilled by operating room staff approximately every 15 minutes     for a total of 3 doses. At the designated time a paracentesis will be performed at the start     of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample     will be immediately stored on dry ice and shipped to a laboratory for analysis.   "
240294|NCT01001819|"     Analysis of differential gene expression in patients with chronic rhinosinusitis without     polyps compared to unaffected patients. Correlation of abnormal gene expression with surgical     outcomes.   "
240295|NCT01001832|"     The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and     immunogenicity of abatacept after subcutaneous and intravenous administration in Japanese     participants with active rheumatoid arthritis and inadequate response to methotrexate.   "
240296|NCT01001845|"     For end-stage renal disease (ESRD) patients, cardiovascular disease remains the single most     common cause of excess morbidity and mortality. Among the examined nontraditional risk     factors, an increase in oxidative stress as well as inflammation are postulated to contribute     to excessive cardiovascular risk in this population.      Flavonoids are naturally occurring substances that possess various pharmacological actions     and therapeutic applications. Some due to their phenolic structures have antioxidant effect     and inhibit free radical-mediated processes, as well as anti-inflammatory effects.     Silymarin,a mixture of three isomeric flavonolignans, is isolated from milk thistle (Silybum     marianum) seeds, and is proven to have anti-oxidant, anti-inflammatory, cell regenerating,     and antifibrotic action.      In this study, the effect of silymarin on oxidative stress and inflammation (2 major risk     factors for cardiovascular morbidity and mortality in hemodialysis patients)is evaluated, and     compared to vit E, a well known antioxidant.   "
240297|NCT01001858|"     The aim of the investigators study was to evaluate the effectiveness of a home programme     (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated     with CPAP and to analyze the cost of this approach.   "
240298|NCT01001871|"     Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient     deficiencies on a worldwide basis, especially in developing countries. The impact of severe     IDA can have mortal consequences, since without adequate hemoglobin, the brain and body     become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown     that iron supplementation in infants and young children can enhance child development,     however, it may also result in increased rates of malaria in high burden areas.      The primary objective of this study is to determine the impact of providing encapsulated iron     (as a powder added to complementary foods) on the susceptibility to clinical malaria among     anemic and non-anemic infants and young children (6-24 months of age) living in a high     malaria burden area.      The value of performing this research in Ghana is primarily that malaria and anemia remain     the most important causes of death and morbidity.   "
240299|NCT01001884|"     Aim:      To examine the effects of the caregiver psychoeducational consultation program in reducing     caregiver burdens, depression, sleep quality, and improving the experience in close     relationship, positive meaning of illness and quality of life.      This is the 2-year study. The design adopts the randomized controlled trial (RCT). The     caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will     be randomly assigned into two groups: one group receiving usual care, another group receiving     the caregiver psychoeducational consultation program (CPCP). The usual care includes     providing education materials only. Measurement time-points include pre intervention, post     intervention, & then 1, and 3 months after the end of intervention for the maintenance     effect.   "
240300|NCT01001897|"     The purpose of this study is to evaluate if the use of misoprostol can make it easier for a     provider, and less painful for a woman, to place an IUD if she has never had a child before.   "
240301|NCT01001910|"     This phase II trial studies how well pemetrexed disodium and carboplatin work in treating     patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Drugs used in     chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.   "
240302|NCT01001923|"     Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain     associated with chronic pancreatitis.      Secondary objectives were:        -  to assess the safety and tolerability of REGN475/SAR164877 in patients with chronic          pancreatitis pain;        -  to characterize the pharmacokinetic, pharmacodynamic, and immunogenicity profiles of          REGN475/SAR164877 in this population;        -  to measure the change in the total daily dose of rescue medications required.   "
240305|NCT01001962|"     Objectives:      Primary      1. Primary prevention of new onset of hypertension      Secondary        1. Reduction of 24h BP in type II diabetics with prehypertension        2. Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects          receiving EMPAGLIFLOZIN        3. Reduction in the total cardiovascular risk        4. 3 years morbidity and mortality rates        5. Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving          EMPAGLIFLOZIN   "
240306|NCT01001975|"     Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor     (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with     and without ensulizole.   "
240307|NCT01001988|"     This is a follow-up of Study JEC02 (NCT 00735644) designed to characterize the persistence of     neutralizing antibodies in the five years after vaccination with Japanese encephalitis     chimeric vaccine (JE-CV).      Primary Objective:        -  To describe the yearly persistence of humoral immune response to Japanese encephalitis          after a single dose of JE-CV   "
240308|NCT01002001|"     Sleep disturbance and sexual dysfunction are common complaints of patients with cirrhosis .     The term sleep disturbance describes insomnia, poor quality sleep, circadian rhythm disorders     and obstructive sleep apnea and is associated with reduced health-related quality of life     (HRQoL) score indices. Sleep and sexual disorders have only been formally evaluated in small     studies in these patients and to date, no studies have objectively assessed these patients.     In addition, no studies have been performed in these patients after liver transplantation.     The investigators' hypothesis is that sleep and sexual disturbance is commonly seen in     patients with advanced cirrhosis and improves after liver transplantation. However, despite     this, HRQoL remain impaired because of residual sleep disturbance.This study will be unique     in providing cross-sectional follow-up of patients with cirrhosis at baseline and after liver     transplantation (> 6 months).   "
240309|NCT01002014|"     The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and     complications after skin sparing mastectomy with preservation of the nipple areolar complex.     These outcomes will be observed in patients with both known cancer diagnosis and in those     with indications for prophylactic mastectomy. The cosmetic appearance and complications will     be followed through several post operative visits throughout the duration of the study. This     study is conducted in conjunction with the plastic and reconstructive surgeons who will be     performing the breast reconstruction procedures. Patient satisfaction will be measured via     survey format. In addition, local recurrence rates will be compared to patients undergoing     traditional mastectomy.   "
240310|NCT01002027|"     The study evaluates three best-practice care pathways for postnatal depression (PND) by     comparing sole General Practitioner (GP) management to GP management in combination with     CBT-based counselling from either a Psychologist or a Maternal and Child Health Nurse (MCHN).   "
240311|NCT01002040|"     The purpose of this study is to assess the safety and effectiveness (immune response) to a     licensed H1N12009 influenza vaccine in HIV-infected adults. The study will enroll 150 adults     (ages 20-59 years). Participants will be randomized into 2 groups and will receive either one     dose or two doses of a licensed H1N1 vaccine. Study procedures include: medical history,     blood samples and completing a memory aid. Participants will be involved in study related     procedures for approximately 6 days.   "
240312|NCT01002053|"     The use of regional anesthesia for nerve block in diabetic patients with peripheral     neuropathy is currently made on a case-by-case basis, also remains underlying uncertainty     regarding the preferred technique and the likelihood of block-related nerve injury. For this     many diabetic patients with otherwise healthy nerves may receive general anesthesia instead     of regional anesthesia, thus giving up the benefits associated with the latter technique,     including a decrease in health complications and superior analgesia following the operation.     Ultrasound is used to identify the target nerve and guide needle insertion for nerve blocks,     may be a useful tool to detect the presence and severity of neuropathy prior to block     placement, a recent study demonstrated a statistically significant increase in the     sonographic cross-sectional area of the posterior tibial nerve (PTN) in all diabetic patients     who had abnormal motor transmission on nerve conduction studies. For regional     anesthesiologists, the ultimate goal of detecting peripheral neuropathy and in particular,     diabetic neuropathy by US is to avoid nerve injury. To do so, the association between     US-detected diabetic neuropathy and block-related nerve damage must be first established,     hence the purpose of this study. We aim to examine whether the cross-sectional area of PTN as     assessed by preoperative US can predict nerve injury as assessed by worsening nerve     conduction studies following PTN block inpatients scheduled to receive an ankle block. A     further subgroup analysis will be performed in diabetic patients.      We hypothesize that the cross sectional area of the PTN will correlate with motor conduction     velocity on nerve conduction studies (NCS) following PTN block in patients with peripheral     neuropathy. All eligible patients will undergo NCS to confirm or exclude distal neuropathy.     Patients without neuropathy will be excluded from further participation in this study. Also     excluded will be diabetic patients with neuropathy caused by genetic, metabolic and     inflammatory diseases as well as toxic agents and drug induced. A systematic US examination     of the PTN will be performed for all patients. After Block administration at surgery day the     block successes will be assessed and for the purposes of the present study, patients in whom     the block was not successful will be excluded from further intervention and data analyses.     Eight weeks after surgery, all study patients will return to hospital for repeat NCS and US.   "
240313|NCT01002066|"     The purpose of this study is to study the effectiveness of wide scale RDT use at the primary     health care level in previously high malaria endemic area during malaria pre-elimination     phase for improved targeting of anti-malarial drugs, malaria surveillance and epidemic     alertness.   "
240314|NCT01002079|"     The purpose of the study is to determine if the concomitant administration of rifampin with     BMS-708163 will affect the Pharmacokinetics of BMS-708163 and to assess safety and     tolerability of co-administration BMS-708163 and rifampin   "
240315|NCT01002092|"     Purpose: This study will assess the safety and efficacy of Endostar combined with     chemotherapy in osteosarcoma patients.   "
240316|NCT01002105|"     This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent     patients.   "
240317|NCT01002118|"     Cardiovascular disease and mortality is the largest comorbidity within the dialysis     population. Nearly 50% of hemodialysis patients will have congestive heart failure at     initiation. According to the most recent United States Renal Data System (USRDS), 40% of     incident dialysis patients will have a cardiovascular event or die within the first 9 months     of dialysis. It has been postulated that Omega-3 fatty acids could provide beneficial     cardioprotection in hemodialysis patients. The investigators propose to evaluate Omega-3     fatty acid doses on cardiovascular parameters in an incident hemodialysis population.     Initially, this will be a pilot study. Ultimately, the information will be used to adequately     plan for a larger intervention trial using Omega-3 fatty acids in incident hemodialysis     patients.   "
240318|NCT01002131|"     The purpose of this investigation is an exact preoperative 3D-localisation of impacted and     supernumerary teeth in the maxilla using Cone Beam Computer Tomography   "
240320|NCT01002157|"     Both Coronary Artery Calcification (CAC)and its annual progression are a strong predictors of     cardiovascular events. The development of arterial calcification results from imbalance     between calcification promoting and inhibiting factors. An important inhibitor of     calcification is Matrix Gla Protein (MGP): a protein present in the vascular wall where it is     synthesized by Vascular Smooth Muscle Cells (VSMC). MGP requires Vitamin K-mediated     carboxylation to function properly. Deficiency of Vitamin K has been demonstrated to cause     arterial calcification and a diet containing large amounts of Vitamin K2 was associated with     lower CAC and cardiovascular risk. In animal studies, active supplementation of Vitamin K2     caused regression of existing arterial calcification. Therefore, the aim of this randomized,     double-blind, placebo-controlled clinical trial is to investigate whether daily     supplementation of Vitamin K2 (Menaquinone-7) to patients with established CAC will lead to a     decreased progression-rate of CAC after 24 months of follow-up in comparison to placebo.   "
240321|NCT01002170|"     In all treatments of tuberculosis, the second-line drugs are usually less effective but have     more drug toxicity than the first-line ones. For the multidrug-resistant tuberculosis     (MDR-TB) patients, who are resistant to the major first-line anti-tuberculosis drugs such as     Rifampin and Isoniazid, the second-line agents, like Cycloserine in this research, are in     frequent use. Taking patients' safety into consideration, therapeutic drug monitoring of     Cycloserine has been listed as a routine examination during the tuberculosis treatment and     established a suggested Cycloserine serum concentration of 20~35 mcg/mL.      While this suggested drug concentration was set up, it isn't suitable to all races in the     world. The investigators plan to develop the therapeutic drug monitoring protocols and a     suggested treating concentration fitting for Asian (Taiwanese). In addition, through this     research, the investigators can also realize that factors causing different pharmacokinetics     and the clinical outcomes in different Cycloserine level.   "
240322|NCT01002183|"     The aim of this study is to evaluate the role of clindamycin and artesunate as possible     combination partners for fosmidomycin to protect it from its susceptibility to recrudescent     infections when used as monotherapy for acute Plasmodium falciparum malaria while retaining     its excellent safety profile   "
240323|NCT01002196|"     Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in     central situations despite ability to talk. SM may cause great suffering and create problems,     both socially and related to learning. SM is associated with social anxiety,     neurodevelopmental delay and bilingualism. The prevalence is about .7-8 ‰. Adequate     assessment and treatment of SM is seldom provided in the mental health services. SM is     considered hard to treat, and randomised treatment studies are lacking. This study will     examine the effect of a manual based treatment for SM. The treatment consists of home- and     kindergarten /school based interventions including behaviour techniques and psychoeducation.     Defocused communication is a general treatment principle. Comorbidity, including     neurodevelopmental delay /disorder, and predictors of outcome, will be examined. A pilot     study was conducted to ensure the feasibility of the planned effectiveness study. Seven     children, aged 3-5 years were included. Six has started treatment, and all talked in the     kinder garden within the first 3 months. The present study will have a randomised controlled     design with 1. Manual based intervention for 6 months compared to 2. Waiting list controls (3     months), and then manual based intervention. The sample: Children aged 3-9 years     consecutively referred to the school psychology- or the mental health services in Oslo and     Eastern Norway. Expected N = 24 based on the pilot study, is a sufficient sample size to     answer our primary research question. The treatment will be given by a therapist from the     research group or by a local clinician under supervision. The study can add essential     knowledge on treatment of SM and make effective treatment available to clinicians in the     community.   "
240324|NCT01002209|"     This trial aims to evaluate if hyperbaric oxygen treatment (HBO) given postoperatively is     effective in reducing healing time and wound complications after lower extremity bypass     surgery in patients with diabetes.      Hypothesis: Postoperative HBO treatment is effective in reducing complications in patients     with diabetes undergoing peripheral vascular surgery   "
240325|NCT01002222|"     This is an open-label extension study of another study protocol, MCS-2-US-a. Subjects who     have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be     eligible for this study.   "
240326|NCT01002235|"     The purpose of this study is to assess the safety and tolerability of injecting VM202 in the     leg muscle in patients with painful diabetic neuropathy (DPN). The study will also assess the     potential of VM202 to reduce the pain associated with DPN.   "
240327|NCT01002248|"     This is a randomized Phase III study to evaluate the efficacy and safety of perifosine when     added to the combination of bortezomib and dexamethasone in multiple myeloma patients who     have relapsed on a prior bortezomib treatment regimen.   "
240328|NCT01002261|"     The elimination of the carbohydrate galactose is used in daily clinical work with liver     patients as a quantitative measure of metabolic liver function, as the liver test The     Galactose Elimination Capacity, GEC. We are working to develop a PET/CT scanning procedure     for providing 3D images of the hepatic galactose elimination and measurement of regional     values. This may be used for example for planning resection or stereotactic radiotherapy of a     patient with malignant tumor in the liver. Will the patient be able to tolerate removal of     the necessary part of the liver? We will include 10 patients with liver cirrhosis and 6     healthy human subjects. Direct measurements of the hepatic galactose elimination (successive     constant iv infusions of galactose in increasing doses with measurements of blood     concentrations of galactose in blood from an artery and a liver vein, and measurements of     liver blood flow by indocyanine green, Ficks principle) are compared with PET/CT measurements     after iv injection of a 18F-labelled galactose analog, FDGal.      Based on previous studies in pigs, we perform detailed calculations of the hepatic galactose     elimination kinetics by the two methods, including estimation of a factor (lumped constant)     for recalculating PET/CT data to data for natural galactose.      Besides possible practical clinical importance, the project elucidates basic problems     concerning liver metabolism using PET.   "
240330|NCT01002287|"     This will be a prospective, multi-center, randomized, single blind study to collect and     evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant     to good surgical technique for the reduction of postoperative adhesion formation following     major open abdominal surgery.   "
240331|NCT01002300|"     Investigations into the components of cognition damaged in frontotemporal dementia (FTD)     demonstrate that patients with FTD show deficits in facial and verbal expression recognition,     lack insight into what others think or might do (theory of mind skills), and in decision     making tasks requiring processing of positive versus negative feedback. These cognitive     functions are thought to be critical for appropriate social behavioural regulation (Blair,     2003). Recent studies in animal models and humans suggest that the neuropeptide oxytocin is     an important mediator of social behavior and that oxytocin may facilitate emotion     recognition, theory of mind processing, and prosocial behaviors (Donaldson and Young, 2008).     Together, these findings suggest that upregulation of oxytocin dependent mechanisms of social     and emotional cognition may be a valuable treatment approach in patients with FTD. The aim of     this study is to determine how administration of intranasal oxytocin to patients with     frontotemporal dementia affects behavior and processing of specific types of social and     emotional information.The investigators' hypothesis is that oxytocin administration will     improve emotional and social cognitive deficits in patients with FTD, resulting in improved     decision making and behaviour.   "
240332|NCT01002313|"     The primary objective of this study is to see whether systemic corticosteroids (such as     Prednisone) have an effect on the peripheral blood Treg and Th17 function in patients with     CRS. Patients are taking prednisone as part of their routine medical care.   "
240333|NCT01002326|"     The purpose of this study is to develop and test the effectiveness of Cognitive-Behavioral     Therapy (CBT) for children and adolescents suffering from Body Dysmorphic Disorder.   "
240334|NCT01002339|"     New onset diabetes after renal transplantation (NODAT) is a common and severe complication     negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the     basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection     and graft function. However, Tacrolimus increases 2 times the risk of NODAT as compared to     CsA.   "
240335|NCT01002352|"     The primary purpose of the Bariatric Outcomes Longitudinal Database (BOLD) study is to assess     the mid- and long-term outcomes of bariatric surgeries and to analyze the relationship     between these outcomes and 1) patient demographics and comorbidities, 2) clinical and     surgical characteristics, and 3) pre-operative, peri-operative and post-operative care and     treatment.   "
240336|NCT01002365|"     Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized     prospective study.   "
240337|NCT01002378|"     An open label, three way crossover study to determine the effect of a high fat breakfast or a     low fat breakfast on the pharmacokinetics of a single dose of regorafenib.   "
240338|NCT01002391|"     This study was designed to determine whether the duration of dressing wear following     reduction mammaplasty influence skin colonization and surgical site infections rates.   "
240339|NCT01002404|"     The purpose of the study is to prospectively evaluate the deep biliary cannulation in ERCP     with the angled tipped guide wire or the straight tipped guide wire.   "
240340|NCT01002417|"     The hypothesis of the study is to examine whether MCS-2 is safe and effective in the     treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.   "
240341|NCT01002430|"     The purpose of the study is to evaluate the safety and efficacy of catheter mediated     endocardial adenovirus VEGF-D gene therapy in patients with severe coronary heart disease.   "
240342|NCT01002443|"     Helicobacter pylori (H. pylori) is associated with gastric cancer in epidemiological     studies.Gastric atrophy and intestinal metaplasia caused by H. pylori are considered as     precancerous lesions, but whether H. pylori eradication improves these lesions is     controversial.The primary objective of this study is to evaluate whether Helicobacter pylori     eradication improves glandular atrophy and intestinal metaplasia which are known to be     precancerous condition in patients undergoing subtotal gastrectomy for gastric cancer.   "
240343|NCT01002456|"     The overall objective of the proposed pilot study is to begin evaluation of two methods for     promoting adherence to guidelines for beta-blocker therapy in heart failure. The design     includes site level baseline measurement, feedback, remeasurement after six months, and     randomized (by site) comparison samples. The setting is VA sites, with intervention directed     at the pharmacy.   "
240344|NCT01002469|"     In this short-term study a method for the evaluation of the metabolic competency of the urea     cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for     patients with urea cycle disorders and to monitor the severity of the disease, a reliable and     safe quantitative method for the measurement of the urea cycle flux is required.      Urea synthesis will be evaluated by administering sodium [1-13C]-acetate and measuring     subsequent incorporation of [13C] label from Na-acetate into urea in healthy volunteers and     asymptomatic subjects genetically disposed to urea cycle disorders.   "
240345|NCT01002482|"     The aim of the study is to determine whether the use of the CGAOtm software is associated     with a decrease in 90-day mortality when compared with the use of standard care methods for     glucose control with target blood glucose levels inferior to 180 mg/dl. The CGAOtm software     is designed to assist physicians and nurses in achieving tight glucose control (defined by a     target for blood glucose levels between 80 and 110 mg/dl) in critically ill patients.   "
240346|NCT01002495|"     The purpose of this study is to evaluate the safety and tolerability of catheter based     injections of VM202 into the heart.   "
240347|NCT01002508|"     The safety and efficacy of vaccination against influenza in patients with scleroderma is not     clear. The objective of this study is to assess its safety and efficacy in 50 patients with     scleroderma in comparison with 30 controls   "
240348|NCT01002521|"     This observational study aims to identify risk factors and molecular mechanisms of impaired     wound healing, to guide better foot care in the diabetic population.   "
240349|NCT01002534|"     The purpose of this study is to investigate the effect of a nasal instillation of Vardenafil     on nasal potential difference in cystic fibrosis patients homozygous for the F508del mutation   "
240378|NCT01002911|"     The goal of the pilot study is to compare conventional antibiotic therapy to an aggressive     antibiotic therapy plan for the prevention of arrhythmia device infection in high-risk     patients undergoing arrhythmia device procedures. All antibiotics are approved for use and     readily available.   "
240350|NCT01002547|"     Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition frequently associated     with type 2 diabetes (T2DM) and characterized by insulin resistance and hepatic fat     accumulation. Liver fat may range from simple steatosis to severe steatohepatitis with     necroinflammation and variable degrees of fibrosis (nonalcoholic steatohepatitis or NASH). Up     to 40% of patients with NAFLD develop NASH in recent series. Risk factors for progression to     NASH are unclear, but appears to be more common and progress more rapidly in older     individuals, and in the presence of obesity and T2DM. Because the VA population in San     Antonio, Texas, frequently combine these risk factors for NASH it was felt that a study     targeting this very high-risk population was needed.      This study will establish the long-term efficacy (primary endpoint: liver histology) and     safety of pioglitazone for the treatment of VA patients with T2DM and NASH. All patients     diagnosed with NASH will be offered lifestyle modification/weight loss (current standard of     care) while being randomized to pioglitazone, vitamin E or placebo for up to 3 years. We     believe that in such a high-risk population for complications from NASH, a substantial     benefit may be expected from early detection and treatment.      Specifically, the arms are: a) pioglitazone + vitamin E; b) vitamin E + placebo of     pioglitazone; c) placebo of both. Patients are randomized to one of these 3 arms, and     followed in a double-blind fashion for up to 18 months. Patients are then offered to continue     into an open-label phase with pioglitazone + vitamin E or vitamin E alone for another 18     months.   "
240351|NCT01002560|"     The purpose of this project is to analyze tumour tissue from a group of subjects with     malignant melanoma, who have been treated at the Royal Marsden Hospital.   "
240352|NCT01002573|"     The primary objective of the study is to determine the superiority of a single dose of     intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first     two hours of treatment.   "
240353|NCT01002586|"     Alzheimer's Dementia (AD) contributes to poor balance, impaired gait and functional status,     thereby, increasing the risk of falls. AD is an independent risk factor for hip fractures.     Those with balance problems and gait impairments are at higher risk for long term placement     and death related to falls. Gait impairments in those with dementia include shortened step     length, increased double support time, step to step variability, and decreased gait speed.     These gait impairments worsen with dual tasking probably due to common brain areas involved     in gait and other cognitive tasks.      Exercise interventions improve gait and balance in the elderly. In subjects with existing AD,     physical activity has shown to prevent further cognitive decline and improve quality of life     and prevent falls. However, it is difficult to engage patients with AD in long term exercise     programs. The expense of physical therapy limits its easy accessibility. Use of everyday     technology might bridge this gap by providing high level of engagement via the use of     multimedia while providing a cost effective alternative. Wii Fit is one such multimedia     platform.      Wii fit is a Nintendo gaming console used for aerobics, strength training and balance     activities. This device includes a balance board that senses weight and shifts in movement     and balance. Virtual trainers talk the user through the activity while tracking the user's     progress.      Although some skilled nursing facilities have started using Wii game system adjunct to     routine physical therapy, there have not been any studies. Anecdotal reports note improvement     in balance and social benefits using the Wii Fit program. Physical therapists report the     ability to customize Wii for each patient. Wii Fit can be successfully used in a cognitively     impaired population. A unique feature of this approach is the enjoyment and enthusiasm that     many patients derive which is reflected in high levels of engagement.      The invesitgators propose an 8 week prospective randomized study with the treatment group     receiving the exercise program delivered by Wii-Fit system and the comparison arm receiving a     walking exercise program in a community dwelling setting. Subjects in each arm will     participate for 30 minutes daily five days a week.   "
240354|NCT01002599|"     This is a randomized controlled study in which morbidly obese patients undergoing bariatric     surgery will be recruited in the preoperative clinic. Patients will be randomized into 2     groups to receive oxygen with Boussignac TM continuous positive airway pressure (CPAP) or     conventional Venturi mask postoperatively immediately after extubation. The objective of the     study is to examine if Boussignac TM CPAP results in improved oxygenation versus Venturi face     mask when it is applied immediately after extubation in morbidly obese patients post     bariatric surgery.   "
240355|NCT01002612|"     To reassess nutritional status of HIV-infected Thai children living in the family style     community after receiving nutrition support program for 6 months.   "
240356|NCT01002625|"     PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats,     which suggests that PF-04457845 is active in rat's brains. This study is designed to see     whether this is also the case in man.   "
240357|NCT01002638|"     Fingers amputations are very common injuries among the patients arriving at the Emergency     Department. Fingertips amputations classified in 2nd and 3rd zones, in accordance with     Rosenthal's classification (after the solum unguis), constitute a large proportion of them.     The treatment aims at restoring a pulp with its sensitivity and a good subcutaneous fat     tissue. The usual care of these amputations is a surgical treatment: it consists of pulp     reconstruction by a flap (for example palmar V-Y advancement flaps of Atazoy). These     technique involve hospital admission, brachial plexus anaesthesia, a surgical approach with     cicatrix and donor site morbidities, postoperative cares, post-surgical pain management. And     of course attention must be paid to the risks of postoperative complications related either     to anaesthesia and/or to surgery, like necrosis, infection, and others. We have developed a     nonoperative treatment for fingertips amputations: the occlusive dressing. It's a technique     that has been known for about twenty years, and that is currently developed by the teams SOS     main of Professor Liverneaux in Strasbourg and of Professor Obert in Besançon. It consists of     the occlusive application of two Tegaderm®, a plastic dressing. Then the finger macerates in     an anaerobic medium, and could develop an uncomfortable smell induced by maceration process.     The first results described by the preclinical studies of these two groups look satisfying on     both the functional aspect (sensibility) and the aesthetic component (preservation of the     finger length and curve), as well as for healing that occurs without infection. Moreover, the     length of the treatment is of about only three or four weeks, and its cost is very low by     comparison with the cost of the surgery itself. Nevertheless this technique is still not very     common, and it has been reported in only five references in the literature [Mennen & Al.,     Farrell & Al., Lee & Al., Allen & Al., Tago Hiroyuk & Al.]. On the other hand, the mechanism     of action and/or the active components of this occlusive dressing have not yet been the     objects of extended studies. An explanatory hypothesis is that some anaerobic germs and/or     growth factors might play an active role in the process. However, they have not been     identified yet. The aim of our study is to validate through clinical and biological criteria     this non operative method and to compare with surgical treatment. The study will be held in     the Hand Department of the University Hospital of Strasbourg, under the direction of the Pr     Liverneaux. It will imply the collaboration of the laboratory of medical bacteriology     directed by Pr Piemont, and the research department of INSERM (Parogène laboratory) will     focus on the biochemistry. From a clinical point of view, a certain number of objective     functional criteria will be measured: the pain will be evaluated by a visual analogic scale     and the DN4 scale; the functional disability will be measured with the french version of the     Disability Arm Shoulder Hand of Dubert; the pulpar 3D volume will be calculated from the     numerical pictures with a computerized file, the cutaneous depth will be measured by 3D U.S;     the tactile sensibility will be tested by standardized monofilaments and Weber's test and the     dermatoglyphics of both handsides will be compared. In addition, the subjective feeling of     the patients will be recorded through a visual and analogical scale of satisfaction. The     purpose of the biological component of the study will be to put into light and to identify     the components that are active in the process. This will be performed by the direct     examination and by bacteriological cultures, and will look for the anaerobic, aerobic germs     and the yeasts.The biochemical studies will first include a non specific search of growth     factors, cytokines and interleukins. In a second step, specific researches will be undertaken     if necessary in accordance with the results of the first investigations. By this study, the     investigators would like to scientifically confirm the efficiency of this method with     objective as well as subjective criteria, and to identify the underlying biomechanisms of the     process.   "
240358|NCT01002651|"     The investigational study product used in this clinical trial is a soft drink containing an     arabinoxylan-oligosaccharides (AXOS) preparation extracted from wheat bran (hereafter called     Wheat Bran Extract, WBE).      The objective of this study is to analyze the effect of the intake of two WBE doses on     various parameters of gastrointestinal health. Additionally, safety was analyzed using     treatment emergent Adverse Events (AEs) and clinical blood parameters.   "
240359|NCT01002664|"     The hypothesis of the study is to examine whether MCS-2 is safe and effective in the     treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.   "
240360|NCT01002677|"     The Midwest Advocacy Project (MAP) is a community-based multiple-site randomized practical     behavioral trial of advocacy skill training for individuals with traumatic brain injury     (TBI), their families, and significant others. The purpose is to evaluate the efficacy of a     4-session advocacy training program to improve behavioral advocacy skills compared to     self-directed advocacy training of the same session frequency. Groups will be randomly     assigned to either a programmed group or a self-directed group in collaboration with the     Brain Injury Associations of Minnesota, Iowa, and Wisconsin each year over the 5 year study     period. The primary outcome is pre-post measures of written and verbal advocacy skill     measured by the Advocacy Behavior Rating Scale.      It is hypothesized that subjects who receive programmed advocacy training will show greater     positive change on pre-post measures of advocacy skill measures than subjects receiving     self-directed training.   "
240375|NCT01002872|"     The aim of the study is to assess the effects of the drug lanthanum carbonate (a phosphorus     binder drug) on c-terminal and on FGF23 levels in patients with Chronic Kidney Disease (CKD).      Targeting FGF23 measurement in CKD patients may impact both the progression of kidney disease     and patient mortality.   "
240376|NCT01002885|"     This study is being done to identify if certain sequences (patterns) of key genes (called     polymorphisms) may predict a response to fertility medications. The investigators will also     determine if the individual response to fertility medications affects pregnancy rates in     in-vitro fertilization.   "
240361|NCT01002690|"     The study is part of a research programme into mechanisms of asthmatic airway obstruction,     focusing on the role of lipid mediators such as the prostaglandins.      To this end the effect of a non-steroidal anti-inflammatory drug, the selective COX-2     inhibitor etoricoxib, will be evaluated in the allergen challenge setting in twelve subjects     with intermittent allergic asthma. Active treatment for 10 to 13 days will be compared with     an identical study period with no treatment in a cross-over, randomised design. Rising dose     allergen challenges will be performed on three occasions to assess possible changes in     airways responsiveness. Sampling of blood, urine, saliva and sputum will be done to allow for     analyses of the production of prostaglandins and other lipid mediators, of the efficacy of     COX-2 inhibition as well as of regulation of immune cells.      It is hypothesized that inhibition of COX-2 by virtue of inhibition of bronchoprotective     prostaglandin E2 leads to a slightly exaggerated airway response to allergen exposure.   "
240362|NCT01002703|"     Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.   "
240363|NCT01002716|"     The efficacy of vaccination against influenza in patients with rheumatoid arthritis has been     assessed using humoral response. However, the cellular immunity is another important pathway     of response to vaccination. The purpose of this study is to evaluate the degree of cellular     immunity response to influenza vaccination. Patient with rheumatoid arthritis and healthy     controls will participate in this study , will undergo a clinical evaluation the day of     vaccination and 4 weeks after. The humoral and cell immunity response will be assessed the     day of vaccination and 4 weeks later   "
240364|NCT01002729|"     This trial asks the question: do people of much greater than average body weight need more of     a drug called oseltamivir than current recommendations suggest. Oseltamivir is a drug given     to people who have influenza, and currently is also being used to fight the new H1N1     influenza. Some people of larger than average body weight require larger amounts of drugs to     see the same effects as others of an average body weight. No studies have ever been conducted     looking at the possibility of oseltamivir being one of those drugs. Our Study's hypothesis     states that those of an above average body weight will have different amounts of drug in     their blood than those of people of normal body weight if they are given the normal amount     prescribed for influenza. Our study will give oseltamivir to twenty people for 7 days. Half     of the people will be of normal body weight and the others will be of a much higher than     normal body weight. Using blood samples the investigators will determine if the amounts of     oseltamivir are significantly lower in the blood of patients in the above normal body weight     group.   "
240365|NCT01002742|"     The study is a Phase III, randomized double blind, placebo controlled, and trial evaluating     the addition of Mycophenolate mofetil (MMF) vs. placebo to systemic corticosteroids as     initial therapy for acute Graft Vs Host Disease (GVHD). The primary endpoint will be GVHD     free survival at Day 56 post randomization.   "
240366|NCT01002755|"     The goal of this clinical research study is to learn if the combination of lenalidomide and     ofatumumab can help to control CLL or SLL in patients who have already received therapy. The     safety of this drug combination will also be studied.   "
240367|NCT01002768|"     This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the     hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in     subjects with type 1 diabetes.      The trial is designed as a two-period, crossover trial where the trial participant is     randomised to one of two treatment periods.   "
240368|NCT01002781|"     Patients with adult's Still disease suffer from acute inflammatory symptoms such as fever,     arthritis, rash, and acute phase response often requiring high dose corticosteroids. In view     of several case reports which have shown dramatic improvement in patients treated with     Tocilizumab and a phase 2 study of this drug in children with Still's disease, the objective     of the current study is to assess the efficacy and safety of Tocilizumab in patients with     adult's Still disease.   "
240369|NCT01002794|"     This study is conducted as a collaboration between NAR, Orthopedic Department, Oslo     University Hospital,Ullevaal, Hjelp24Nimi Oslo, Norway, and University of Southern Denmark,     Odense, Denmark.      The investigators hypothesize that exercise is more effective than arthroscopic partial     meniscectomy: a) on self-reported outcomes, functional performance and muscle strength in     middle-aged patients subsequent to arthroscopic partial meniscectomy for a degenerative     meniscus tear, and b) in preventing further development of knee osteoarthritis (OA).   "
240370|NCT01002807|"     To assess the relative bioavailability of dapagliflozin and metformin from the two FDC     formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to     coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in     healthy subjects in a fasted state.   "
240371|NCT01002820|"     This study is designed to provide ganaxolone to those patients deriving significant benefit     from current treatment in protocol 1042-0601.   "
240372|NCT01002833|"     Plasmodium falciparum isolates display a wide genetic diversity with possibly different     properties to induce immune responses. These properties could directly influence the ability     to induce protective efficacy. Since 1998 an experimental human malaria infection model at     the Radboud University Nijmegen Medical Center (RUNMC) has been very successful in answering     questions with regards to immunological mechanisms of human Pf infection. To date only the     NF54 strain of Pf has been deployed in this Nijmegen model. However, investigation of     heterologous Pf challenge is not only highly informative for our basic understanding of     induction of immune responses but also provides an essential model for protective capacity     testing in the clinical development of candidate malaria vaccines. Recently, the parasite     culture laboratory of the RUNMC has been able to overcome technical hurdles to produce     infectious mosquitoes of two genetically different isolates from different geographical     regions to increase the portfolio for Phase IIa trials. These isolates, PfA and PfB will be     compared with the NF54 strain for parasitic, immunological and clinical features in humans.   "
240373|NCT01002846|"     This is randomised, controlled study about effects of acupuncture on blood pressure and     endothelial dysfunction in stage I hypertension patient without medication. Subject will     receive 8 weeks of either acupuncture or sham acupuncture, measuring FMD and blood test     before and after treatment.   "
240374|NCT01002859|"     Observe the effect of preliminary cyclosporine administration on different markers of cardiac     ischaemia led by the aortic cross-clamp during coronary artery bypass surgery with     Cardiopulmonary bypass.   "
240382|NCT01002963|"     The purpose of this study is to investigate safety and toleration of single oral doses as     well as the time course of PF-04418948 concentration in the blood following dosing by oral     solution.   "
240383|NCT01002976|"     Omalizumab is an anti-IgE recombinant humanized monoclonal antibody.The efficacy and     tolerability of omalizumab have been demonstrated in patients with moderate-to-severe and     allergic (IgE-mediated) asthma. Clinical benefit with omalizumab is observed when serum free     IgE levels are reduced to 50 ng/mL or less. However, although the causal role of IgE in     allergic disease is well established, the relationship between free IgE and clinical symptoms     of asthma has not been accurately quantified. Recent study demonstrated that omalizumab and     free IgE concentrations are correlated with clinical outcomes. In non responder to omalizumab     the clinical symptoms show random fluctuations around baseline without any tendency toward     improvement despite adequate suppression of free IgE. In these patients it may be the ratio     of specific IgE to total IgE or inter-patient variability in the expression of FceRI on     effector cells that define whether the patient will respond or not to omalizumab.      This current study is designed to evaluate the mechanisms of responsiveness to omalizumab     measuring the free IgE, specific IgE and the level of FceRI expression on the effector cell     and the correlation to clinical response.   "
240384|NCT01002989|"     Measurement of the ankle-brachial index (ABI) with the oscillometric device WatchBP Office     will be assessed compared to the reference method (Doppler).      Ninety three adult subjects assessed for hypertension, treated or untreated, with complete     study data were included. Data on the presence of cardiovascular (CV) disease and classical     CV risk factors were recorded.      All the ABI measurements of each individual participant will be performed by the same     observer in a randomized order (concerning Doppler and WatchBP)   "
240385|NCT01003002|"     Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and     uncontrolled movements called dyskinesias (LID). The severity of these movements can range     from subtle to extremely debilitating. These movements may or may not interfere with normal     activities such as putting on a coat or brushing ones teeth. Current estimates of the     occurrence rate of LID range from 12 % to 100% after one year of levodopa treatment. These     estimates used reporting mechanisms such as self-report and doctor-reported. These reporting     mechanisms are not reliable. We will use an objective measure of dyskinesia in the first 5     years of treatment for Parkinson's disease. The purpose of this protocol is to use an     objective measure to estimate dyskinesia onset.   "
240386|NCT01003015|"     The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink     or delay the growth of tumors in patients with unresectable liver cancer.   "
240387|NCT01003028|"     This study is intended to evaluate the effect of decreasing the maximum plasma concentration     target of remifentanil of the Target Controlled Infusion system on the the incidence of major     and minor side-effects.   "
240388|NCT01003041|"     The purpose of this study is to record voice samples of infant's mothers, process in samples     to a phonetic musical piece, play the phonetic musical piece to 4-10 month old infants, and     then test the infants in a conditioned head turning test in lab, and to analyze the results.   "
240389|NCT01003054|"     The goal of this clinical research is to learn if treatment with high-dose busulfan and     cyclophosphamide plus autologous bone marrow transplantation followed by treatment with     Gleevec (imatinib mesylate) is effective in treating chronic myelogenous leukemia (CML).      Objectives:        1. To assess the efficacy of high dose busulfan-cyclophosphamide and autologous          hematopoietic transplantation with post transplant Imatinib mesylate for the treatment          of CML. The primary endpoint of the study is to determine the proportion of patients          with CML alive in cytogenetic remission at one year following this treatment.        2. Secondary endpoints are time to progression and survival.   "
240390|NCT01003067|"     Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation     after laparotomy (Group 1) in a randomized control trial compared with patients with standard     abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the     feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound     infection and incisional hernia.   "
240391|NCT01003080|"     The use of Aquamantys during total knee arthroplasty will reduce drain output and the     necessity for blood transfusions.   "
240392|NCT01003093|"     The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit     vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior     history of TB disease or known prior exposure to TB   "
240393|NCT01003106|"     The primary Objective of this study is to evaluate the safety and tolerability of intraocular     injections of 0.5mg or 2.0mg of ranibizumab in patients with macular edema due to retinal     vein occlusion.   "
240394|NCT01003119|"     The purpose of this grant is to develop and test a proven computer based quality     improvement/behavior change e-Health system (CHESS--Comprehensive Health Enhancement Support     System) to help prevent relapse in alcohol dependent patients being discharged from     residential treatment. The investigators' primary hypothesis is that ACHESS (Addiction CHESS)     will improve competence, relatedness and autonomy, which will reduce the days of risky     drinking over a 12-month period.   "
243333|NCT01040780|"     The purpose of this study is to determine whether Icotinib is at least non-inferior to     Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one     or two chemotherapies.   "
240395|NCT01003132|"     This research investigates a new talking therapy aimed at helping people to come to terms     with the experience of psychosis. The new therapy is called Acceptance and Commitment Therapy     for psychosis (PACT). PACT aims to help people:        1. Develop a sense of mindfulness. Mindfulness allows you to be fully aware of your          here-and-now experience, with an attitude of openness and curiosity. It is hoped that          this will help reduce the impact of painful thoughts and feelings.        2. Take effective action that is conscious and deliberate, rather than impulsive. It is          hoped that this will allow people to be motivated, guided, and inspired by the things          that they value in life.      It is hoped that PACT will help to reduce the level of distress that individuals diagnosed     with psychosis have been experiencing and help them to stay well in the future.   "
240396|NCT01003145|"     This was a randomized, laboratory-blinded study in healthy male and non-pregnant female     designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated     influenza H1N1 vaccine (AdimFlu-S). In the adult cohort, all volunteers were randomized in a     1:1:1 ratio to receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart, 2     injections of AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart or 1 injection of AdimFlu-S     (A/H1N1) 15 mcg HA. In the elders cohort, all volunteers were randomized in a 1:1 ratio to     receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart or 2 injections of     AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart.      Following immunization, safety was measured by assessment of adverse events for 6 weeks     following the first vaccination, serious adverse events and new-onset chronic medical     conditions through 7 months post first vaccination; and reactogenicity to the vaccines for 7     days following each vaccination. Immunogenicity testing included hemagglutinin inhibition     (HAI) testing on serum obtained before first vaccination, and three and six weeks after first     vaccination.   "
240397|NCT01003158|"     The main purpose of this study is to determine if AZD8931 can be safely administered in     Japanese patients alone and in combination with weekly paclitaxel. The study will be     conducted in two parts: a monotherapy and a combination part, where safe doses of study     treatment will be determined.   "
240398|NCT01003171|"     This study is to examine the pharmacokinetics, absorption and serum concentrations of MCS and     other components after once-daily oral dosing of MCS.   "
240399|NCT01003184|"     The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin     detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and     patient reported outcomes.   "
240400|NCT01003197|"     To develop and validate a score to predict serious complications following liver resection     using pre-operative risk factors.   "
240401|NCT01003210|"     The purpose of this study is to determine if a commercially available homeopathic ear drop     preparation is effective in reducing symptoms in children 6 months - 11 years old with acute     otitis media in whom the health care provider has recommended that antibiotics not be     immediately administered. A total of 150 study patients with otitis media will be randomized     to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It     is postulated that children using the ear drops will have more rapid resolution of symptoms     and need fewer antibiotics than those randomized to not receive the ear drops.   "
240402|NCT01003223|"     Cardiovascular disease is a major cause of death in hemodialysis (HD) patients and is     associated with widespread vascular calcification. There is a consensus that the chronic     overload of calcium and phosphorus is a major factor in vascular calcification.     Hyperphosphatemia, deleterious in dialysis patients, is aggressively monitored and treated.     Phosphate binders - designed to bind dietary phosphate and thus prevent its absorption, are     ubiquitous in the dialysis patient population, and calcium-based phosphate binders are often     first line therapy because they are tolerated well by the patients and low in cost. Phosphate     Kinetic Modeling (PKM) is a tool to help physicians manage a hemodialysis patient's phosphate     level. Once a subject consents to participate in the study, the subject's dietary phosphate     intake will be estimated and the appropriate dose of the phosphate binder calcium acetate     (PhosLo) will be recommended accordingly. If necessary, the Ca++ concentration of the     dialysate will be changed to remove any excess calcium absorbed as the result of an increase     in the PhosLo prescription to control phosphorus.Ongoing recommendations regarding oral     phosphate binders dialysate calcium will be made using a computer generated algorithm.   "
240403|NCT01003236|"     There is considerable evidence that increased blood glucose results in the generation of     reactive oxygen species, ultimately leading to increased oxidative stress in a variety of     tissues. This may lead to the activation of stress-sensitive intracellular signaling     pathways, causing cellular damage and late complications of diabetes including renal injury.     Although the investigators understanding of how hyperglycemia-induced oxidative stress     ultimately leads to tissue damage has advanced considerably in recent years, effective     therapeutic strategies to prevent or delay the development of this damage remain limited. The     flavonoid complex silymarin, an extract from the milk thistle, and its major pharmacological     active component silibinin are free radical scavengers and potent membrane stabilizers by     preventing lipid peroxidation. Furthermore, during early stages of diabetes, flavonoids     minimize oxidative stress, and inflammation which represent important factors in the     development of diabetic nephropathy.      In this study the investigators plan to evaluate the renoprotective effect of milk thistle     extract on type II diabetic patients with kidney disease.   "
240412|NCT01003353|"     The study aims to investigate the effects of strength training on maximal strength, walking     ability and neural function in chronic stroke patients. The strength training intervention in     this study is different to all previous interventions for stroke patients.      Maximal Strength Training (MST) involves weights of up to 90% of the participants 1     repetition maximum and has a focus on the explosive development of force. This study will use     these principles for unilateral leg press and plantarflexion exercises. Only 2 previous     studies have investigated high intensity strength training for stroke patients and they used     intensities of 80% 1RM. Previous MST interventions have shown large increases in strength,     rate of force development and this has transferred to improved walking economy.      The investigators predict that MST will give large increases in strength, improved rate of     force development (RFD) and walking economy. The investigators expect that better neural     function will account for the improvements. This study could provide evidence for the     adoption of a completely different method of strength rehabilitation for stroke survivors.   "
240430|NCT01003587|"     The purpose of this study is to assess the impact of disseminating information on comparative     performance, along with actionable messages on how to improve health outcomes, to     district-level decision-makers in India using a randomized, controlled design. This     information should improve prioritization of health services by district health officers,     budget allocation for health, and implementation of priority health services at the district     level.   "
240431|NCT01003600|"     We are doing this study to learn more about colon and rectal cancer survivors. We want to     know if survivors want more information about life after cancer. Do cancer survivors want to     know more about their own cancer? Do cancer survivors want to know about their treatment? Do     cancer survivors want to know what health care they should get in the future? We want to know     what information to give to cancer survivors when they finish treatment.   "
240404|NCT01003249|"     Dysfunctional voiding is often associated with constipation. The association of constipation     with urologic pathologic processes has previously been described since the 1950's, but it was     only over the past decade that clinicians have paid more attention to this relationship and     recognized it existence with the term dysfunctional elimination syndrome (DES). This term is     used to reflect the broad spectrum of functional disturbances that may affect the urinary     tract including that of functional bowl disturbances and can be classified as follows:        -  Functional disorder of filling: overactive bladder, over distention of bladder or          insensate bladder, which may be associated with fecal impaction or rectal distention          with infrequent bowel movements        -  Functional disorder of emptying: over-recruitment of pelvic floor activity during          voiding causing interrupted and/or incomplete emptying also associated with defecation          difficulties due to non- relaxation of the puborectalis muscle, dyssynergic defecation          or pain with defecation Several different therapeutic options have been used for          patients with dysfunctional voiding mainly to decrease bladder outlet obstruction. These          treatments including, alpha adrenergic antagonists, and botulinum toxin are less than          optimum. One possible explanation for these drug failures includes the inability of          these medications to relax the striated muscles of the pelvic floor necessary for          voiding.      To date there has been no data to evaluate the role of baclofen on the striated muscle of the     external anal sphincter, essential in the defecation process.   "
240405|NCT01003262|"     Syncope, defined as a transient loss of consciousness, accounts for over 700,000 annual U.S.     emergency department visits and may herald a life-threatening condition in older adults     (age≥60 years). Existing risk prediction instruments cannot reliably identify who among such     older patients can safely be discharged home from an emergency department. As a result, the     majority of older patients without a clear cause for syncope are hospitalized for diagnostic     evaluation. However, current admission practices are characterized by low diagnostic yield,     do not clearly improve outcomes, and account for over $2.4 billion in annual hospital costs.     Most admitted patients are discharged within 48 hours, and approximately 50% of patients do     not have an identified cause of syncope after their hospitalization.      The implementation of an expedited and standardized Emergency Department Observation Syncope     Protocol (EDOSP) may safely reduce hospitalization of older patients with syncope. The     investigators propose a pilot randomized trial to implement and evaluate EDOSP at two     emergency departments. This study has the following exploratory Specific Aims:        1. To compare admission rates and length-of-stay associated with EDOSP to standard care.        2. To compare serious outcomes rates associated with EDOSP to standard care.        3. To compare quality-of-life associated with EDOSP to standard care.        4. To compare the incremental costs and cost-effectiveness of EDOSP to standard care.      Over a one-year period, 120 intermediate-risk older adults who present with syncope at the     two study sites will be randomized to 1 of 2 arms: 1.) intervention arm: expedited and     standardized EDOSP care; or 2.) control arm: routine care consisting of admission from the     emergency department.      If this pilot trial suggests that EDOSP can safely reduce admissions, then the investigators     will plan a larger study powered to evaluate clinical, quality-of-life, and economic     outcomes. A successful EDOSP intervention would have important clinical policy implications     and improve the emergency department care of older adults with syncope.   "
240406|NCT01003275|"     The purpose of this study is to determine if treatment with paricalcitol, an active form of     vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic     Kidney Disease (CKD).   "
240407|NCT01003288|"     Haukeland University Hospital has approximately 8000 employees many of whom will be in the     front line to receive the pandemic A/H1N1 vaccine. We propose to conduct a safety and     immunogenicity study in these subjects   "
240408|NCT01003301|"     This research is being done to study the effects of the drug omalizumab (Xolair) in people     with cat allergies. The investigators will use omalizumab to study changes in the cells in     the nose, cells in the blood and cells in the skin that cause allergies. The investigators     will compare the changes in the nose to changes in the skin and blood cells.      Objective: To test the hypothesis that treatment with omalizumab will decrease the nasal     allergen challenge late-phase eosinophil count in nasal brushings at the time when blood     basophils have become hypo-responsive to in vitro allergen exposure.   "
240409|NCT01003314|"     This study aims to test the safety of two new malaria vaccines AdCh63 MSP1 and MVA MSP1.     These vaccines consist of inactivated viruses which have been modified − so they cannot     reproduce (replicate) in humans, and also to include genetic material (genes) for malaria     proteins which are expressed by the malaria parasite during blood stage infection. The     vaccines are designed to stimulate an immune response to these malaria proteins     (immunogenicity describes the nature and magnitude of this immune response), to provide     protection against malaria infection. This protection has been demonstrated in nonhuman     studies. Although these vaccines have not been given to humans before, similar vaccines using     the same viruses with different malaria genes have been given to humans before. In these     studies, the vaccines have been shown to be safe. They have also provided evidence from     laboratory tests of immunogenicity. In this study the investigators main aim is to ensure     these new vaccines given alone and in combination are safe. The investigators will increase     the dose of the first vaccine (AdCh63 MSP1) given to volunteers if the initial dose is safe.     The investigators also wish to ensure that challenging a small number of volunteers who have     received both vaccines with malaria infection from the bites of infected mosquitos(sporozoite     challenge) is safe. Sporozoite challenge has been widely used in humans to test the     effectiveness of malaria vaccines and is considered a well established, reliable, predictable     and safe system.In the study the investigators will also look for evidence of immunogenicity     of these new vaccines, and whether there is any delay to developing malaria following     sporozoite challenge. The study will be conducted at the University of Oxfords Centre for     Clinical Vaccinology and Tropical Medicine (CCVTM). The challenge part of the study will take     place at the insectary at Imperial College, (Infection and Immunity Section)in London.   "
240410|NCT01003327|"     The intention of this study is to compare the performance of the single-use I-gel laryngeal     mask with the classic laryngeal mask in 50 patients with a BMI>25 during elective surgery.     Primary outcome is the leak pressure. Secondary outcomes include ease and duration of     insertion.   "
240411|NCT01003340|"     The investigators propose to test the hypothesis that a home-based asthma intervention, the     Wee Wheezers program, delivered by the Community Health Workers and tailored to the needs of     the investigators community, will improve anti-inflammatory medication adherence, parental     asthma knowledge and management behaviors, which in turn will reduce asthma morbidity     (defined as days with asthma symptoms) and health care utilization (defined as asthma-related     Emergency Department visits) among low-income, minority children with persistent asthma in     the Bronx.   "
240413|NCT01003366|"     To test the hypothesis that approaching the internal jugular vein with the needle bevel down     would produce less injury to the vessel wall compared to the bevel up approach during central     venous catheterization.   "
240429|NCT01003574|"     This study will test a 2-tiered tailored intervention and evaluation of cardiovascular health     outcomes among survivors designed to inform childhood cancer survivors about their individual     cardiac risk and follow-up recommendations and to provide motivational support for     cardiovascular (CV) screening. This study will test if the addition of telephone motivational     interviewing, tailored to behavioral constructs, is superior to the current standard of care     in increasing survivors' CV screening.   "
241335|NCT01019668|"     The purpose of this study is to evaluate the effectiveness as well as the detrimental     influence of half-dose and half-fluence modification of verteporfin photodynamic therapy     (PDT) for the treatment of prolonged unresolved central serous chorioretinopathy (CSCR).   "
240414|NCT01003379|"     Schizophrenia affects approximately 1% of the population worldwide, and in about 80% of     cases, it is a lifelong, disabling illness. It is a multi-dimensional disease that is     associated with symptoms that have been characterized as positive, negative, and cognitive.     CDS is a core feature of schizophrenia, and most individuals with schizophrenia exhibit     cognitive impairment. Attention disorders, slow information processing, working memory     disorders, and lack of flexibility for adaptive strategies are symptoms of cognitive     impairment that have a devastating impact on the function, employment, and social status of     patients with schizophrenia.      Older typical neuroleptic medications (e.g., haloperidol, fluphenazine) do not improve     cognition. In fact, haloperidol has been shown to induce cognitive impairment in     schizophrenic patients.      Novel atypical antipsychotics, such as risperidone, clozapine, and olanzapine, seem to     produce gains in cognition. This improvement may reflect a diminution of extrapyramidal side     effects of the typical high potency neuroleptics. Alternatively, it might reflect more     effective symptom reduction by the novel antipsychotics, or direct cognitive enhancement     through the effects of the newer agents on a variety of neurotransmitters, their receptors,     and gene expression. Even when the newer antipsychotic medications improve cognition, they do     not normalize it.      Presently, there are no approved therapies for CDS. However, in schizophrenic patients,     nicotine improves multiple cognitive domains, including working memory and attention.     Furthermore, based on a strong body of evidence ranging from genetic mapping to clinical     trials, the alpha7 NNR subtype has emerged as a primary therapeutic target relevant to CDS     and other core symptoms of schizophrenia   "
240415|NCT01003392|"     Coffee is a worldwide drink, been part of any culture. There are some concerns about effects     of coffee on the health. Recently, epidemiological studies have shown benefits of coffee     drinking to diabetics and also to prevent diabetes in populations. We aim to understand some     effects of coffee and not only caffeine over vascular system, in special coronary artery     disease patients, diabetics end normal people.   "
240416|NCT01003405|"     To investigate the long-term safety, efficacy and pharmacokinetics of KUC-7483 in patients     with overactive bladder.   "
240417|NCT01003418|"     The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1     candidate vaccine administered in children aged between 8 and 12 weeks at the time of first     vaccination.   "
240418|NCT01003431|"     This study will evaluate the immunogenicity and safety of the pertussis component of DTwP     (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or     Rotatrix™.   "
240419|NCT01003444|"     Biopsies of the outer thigh muscle and serum samples will be collected from untreated healthy     subjects. These biological samples will be provided to the Diabetes Research Unit     Translational Biomarker Laboratory for use in developing and validating human muscle malonyl     CoA and serum malonate biomarker assays.   "
240420|NCT01003457|"     In the last decade, several authors proposed ultrasound measurement of Bladder wall thickness     (BWT) for the screening of the voiding dysfunction and of the detrusor overactivity (DO). The     aims of the investigator prospective study were:        -  to compare the ultrasonographic measurement of BWT in women with DO vs women with other          urodynamic diagnosis in a very large population.        -  to verify whether the BWT in women with DO can be different in the clinically or          urodinamically different forms of DO.   "
240421|NCT01003470|"     The purpose of this study is to evaluate the therapeutic effect of acupuncture method of     Xing Nao Kai Qiao for paralysis as an apoplectic sequela in a multicenter randomized and     controlled clinical trial and to compare the efficacy between acupuncture and rehabilitation     therapy. In addition, evaluating the trial in the view of medical economics.   "
240422|NCT01003483|"     The purpose of this study is to compare the influence of Orlistat and Metformin on obesity     treatment in obese PCOS women.   "
240423|NCT01003496|"     The purpose of this 2 year study is to conduct a fully powered effectiveness trial comparing     recovery trajectories of 200 drug dependent adults (the subjects) who will be randomly     assigned to Treatment as Usual (TAU) or TAU + Long-Term Recovery Management (LTRM).   "
240424|NCT01003509|"     This is a new inguinal hernia repair technique.   "
240425|NCT01003522|"     To investigate whether the use of airways stents (metal tubes to open and keep open narrowed     airways) together with the standard treatment increases the proportion of patients who can     complete a 6min walking distance (6MWD) test at 2 weeks +/- 2days in patients with     breathlessness due to lung cancer, when compared to standard treatment alone.   "
240426|NCT01003535|"     Parkinson´s disease is based on a Lewy body degeneration of cerebral and extracerebral     neurons. This Lewy body degeneration includes cerebral cholinergic neurons besides     dopaminergic neurons.      In previous studies the investigators found that some clinical parkinsonian symptoms -     primarily hypokinesia and rigidity - significantly correlate with the dopaminergic     nigrostriatal degeneration which was quantified by dopamine transporter imaging. In contrast     to that, resting or postural parkinsonian tremor does not correlate with the dopaminergic     nigrostriatal degeneration. Obviously further cerebral changes - for instance possible     changes / degeneration of cerebral cholinergic neurons - contribute to parkinsonian tremor.      In this study the investigators apply cerebral 5-IA-85380-SPECT to quantify the local density     of cerebral nicotinergic cholinergic receptors in patients with Parkinson´s disease. The     investigators will correlate the results of cerebral 5-IA-85380-SPECT with the clinical     parkinsonian main symptoms hypokinesia, rigidity and primarily resting and postural tremor.     In particular, it is of interest whether changes of cerebral cholinergic neurons are involved     in the generation of parkinsonian tremor.   "
240427|NCT01003548|"     Embryo culture is a cornerstone of in vitro fertilization treatments. Usually, embryos are     cultured in microdrops of culture media in incubators with controlled temperature, humidity     and atmosphere. However, these culture systems are static, while in vivo the initial growth     of the embryo takes place in the uterine tube and they are submitted to a dynamic     environment. The aim of this study is to compare the embryo development on days 2 and 3 of     culture morphological features of embryos under static and dynamic(microfluidics) systems of     culture.   "
240428|NCT01003561|"     The aim of this study is to evaluate the changes of venous flow, volume, and resistance in     upper (basilic v.) and lower (popliteal v.) extremities of the elderly healthy patients     compared with elderly hypertensive patients who undergoing spinal anesthesia for     transurethral prostatectomy.   "
240432|NCT01003613|"     Recurrent or secondary pterygium often has often a growing fibrovascular tissue more     exuberant than the primary. Histological findings differ from the primary, since the typical     changes in the degenerate connective tissue are absent. The strong immunoreactivity and     release of basic fibroblast growth (b-FGF) in cultured fibroblasts of recurrent pterygia     suggest that fibroblasts may play an important role in pterygium recurrence. Tranilast used     is an antiallergic drug that has an inhibitory effect on the release of chemical     transmitters, such as histamine and leukotrienes from mast cells as well as a suppressive     effect on vascular permeability.This drug also reduces TGF-β1 production and collagen     synthesis in various cells. Tranilast might reduce pterygium recurrence by suppressing TGF-β1     synthesis in conjunctival fibroblast after pterygium surgery. The investigators want to     confirm these findings and also compare the recurrence rate between the two types of surgery.     Tranilast might be an alternative of mitomycin use, and also less toxic. This study aim to     compare the effectiveness of preventing recurrence by using tranilast by topical     subconjunctival administration previous to conjunctival autograft transplantation surgery in     cases of primary pterygium, and will be perform clinical evaluation and TGF-beta-1     immunohistochemical detection by the anti-TGF-beta 1 antibody as well as fibroblast culture.   "
240433|NCT01003626|"     The goal of this clinical research study is to learn about the side effects of measuring the     tumor pressure in patients who have advanced melanoma and have not received chemotherapy.     Researchers also want to learn if patients with a lower tumor pressure may respond better to     chemotherapy.   "
240434|NCT01003639|"     Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of     elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991].     Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age,     and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about     100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the     optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop     severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with     unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic     nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The     purported goal of these therapies is to lower intracranial pressure; however, it is unclear     which treatments work and by what mechanism. None of these strategies has been verified by     properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific     rationales to guide treatment decisions. This trial will study subjects who have mild visual     loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to     restore and protect vision, (2) follow subjects up to 4 years to observe the long-term     treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be     divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not     required to complete the observational phase of the study, but will be asked to do so and     consented for the observational phase of the study at the conclusion of the intervention     phase (12 months).   "
240435|NCT01003652|"     The purpose of this study is to evaluate the technical benefits, advantages and limits of the     use of the Harmonic Focus curved shears in total thyroidectomy.   "
240436|NCT01003665|"     The purpose of this study was to compare the Continuous Non-invasive Arterial Pressure (CNAP)     monitor with the gold standard of invasive arterial pressure monitoring during:        1. induction and maintenance of general anaesthesia        2. intensive care unit treatment of postoperative patients with an ASA 3 or 4 status   "
240437|NCT01003678|"     This is a Phase I trial for patients with intermediate or high risk myelodysplastic syndrome     (MDS).      The study agent, clofarabine, is produced by Genzyme Pharmaceuticals.   "
240438|NCT01003691|"     The purpose of this study is to determine the safety and tolerability of multiple doses of     RN6G in subjects with advanced dry, age-related macular degeneration including geographic     atrophy.   "
240439|NCT01003704|"     Phantom limb pain (pain originating from where an amputated limb once was) is a common     occurrence after lower extremity amputations, with some sources noting incidence to be as     high as 60-80% six months after surgery. This pain can eventually subside, however, cases     have been reported of incidence 10 years after surgery. This pain is not only physically     detrimental, but can also be psychologically detrimental after a difficult to accept change     in the body. Prior studies have been performed using regional anesthetic techniques     (including spinals and epidurals) and different medications to attempt to reduce the     incidence of phantom limb pain, however, the data have been mostly inconclusive. Of interest,     prior studies have not addressed peripheral nerve blocks, a method of anesthesia/analgesia     more commonly employed for amputations recently. The purpose of our retrospective study is to     look at the incidence of phantom limb pain at our institution over a two year period to     determine if peripheral nerve blocks result in a significantly reduced incidence compared to     other techniques (spinal, epidural, general anesthesia only). In addition, there is little     data on relation of reason for amputation and presence of preoperative neuropathy and     incidence of phantom pain. As secondary endpoints, the investigators wish to investigate if     certain reasons for amputation (trauma, peripheral vascular disease, diabetes, and others)     and/or neuropathy lead to a higher incidence of phantom limb pain. The results of this study     could impact future management of patients who are to receive amputations and may lead to     further prospective studies on the topics involved.   "
243334|NCT01040793|"     To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of     treatment in patients with Chronic Obstructive Pulmonary Disease.   "
240440|NCT01003717|"     Single-center registry of patients treated with at least one Endeavor, zotarolimus-eluting,     Stent as the primary treatment for acute coronary syndrome at the Washington Hospital Center,     with the aim of assessing clinical success and safety at 30 days, 6 months and annually for     up to 3 years post Endeavor Stent implantation.   "
240454|NCT01003912|"     The purpose of this study is to determine if it is safe to administer unrelated umbilical     cord blood to pregnant women in their first trimester of pregnancy with a fetus that has a     known diagnosis of certain lysosomal storage diseases. These diseases are known to cause     severe and irreversible neurological disability in early infancy and which are lethal in     childhood.   "
240441|NCT01003730|"     This research is being done to determine if there is a way the investigators can improve the     techniques that they use to assist patients with their breathing during surgery. The majority     of surgeries require patients to concurrently undergo general anesthesia. This usually     includes a breathing tube and a machine that breathes for the patient during the duration of     the surgery. The doctors would like to investigate the effects of this type of anesthesia to     healthy adult patients and whether they can improve the way they give general anesthesia to     patients. The investigators plan to ask approximately 200 patients to participate. If the     patients decide to participate in the study,some additions will be made to the standard     anesthetic care they receive. The patients will additionally be monitored for adequate     oxygenation in their blood as well as level of inflammation in their blood and lungs. The     patients' breathing tube will be bathed with warm normal saline and suctioned twice during     the operation. When these procedures are done the patients will be asleep and not be aware of     what is happening.   "
240442|NCT01003743|"     Registry is designed to evaluate use of endolumenal tissue anchors for soft tissue     approximation to repair a dilated gastric pouch and gastrojejunal anastomosis in     post-Roux-En-Y gastric bypass patients presenting with weight regain. Registry will also     assess tissue anchor durability.   "
240443|NCT01003756|"     This study is conducted in the Community Hospital in Svendborg (OUH Svendborg Sygehus) in     collaboration with University of Southern Denmark and Odense University Hospital.      The overall purpose of this study is to evaluate the effects of preoperatively delivered     neuromuscular exercise on self perceived physical function, pain and Quality of Life in     patients undergoing total hip or knee replacement. Secondary area of interest is physical     performance, muscle function, and level of physical activity.      The project will be conducted in two phases:        -  A pilot project focusing on the logistics of the upcoming randomized controlled trial          (RCT) and determination of test-retest reliability of specific muscle strength variables          for the patients of interest        -  A randomized and controlled trial where the intervention is preoperative neuromuscular          exercise and the controls receive standard instructions.   "
240444|NCT01003769|"     This phase I/II trial studies the side effects and best dose of lenalidomide when given     together with R-(-)-gossypol acetic acid and to see how well they work in treating patients     with B-cell chronic lymphocytic leukemia (B-CLL) that has returned after a period of     improvement (relapsed). Biological therapies, such as lenalidomide, may stimulate the immune     system to attack cancer cells. R-(-)-gossypol acetic acid may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth and causing the cells to die. Giving     lenalidomide with R-(-)-gossypol acetic acid may be an effective treatment for relapsed or     refractory B-CLL. - Funding Source - FDA OOPD   "
240445|NCT01003782|"     Background: Antibiotic treatment of cholangitis often remains insufficient due to     inappropriate antibiotic use or bacterial resistance.      Objective: To evaluate the role of routine bile collection during endoscopic retrograde     cholangiography (ERC) or percutaneous transhepatic cholangiography (PTC) for microbiological     analysis in the antibiotic management of cholangitis and to identify risk factors of     microbial growth.      Design: Prospective, observational, diagnostic study.      Setting: Hannover Medical School, Hannover, Germany. Patients and Interventions: Consecutive     patients undergoing ERC/PTC for biliary complications after orthotopic liver transplantation     , malignancy, primary sclerosing cholangitis, benign strictures and choledocholithiasis.      Main outcome measurements: Microbiological examination of bile samples   "
240446|NCT01003795|"     Single-center registry of patients treated with at least one Promus, everolimus-eluting,     Stent, with the primary objective to assess clinical success and safety at 30 days, 6 months     and 1 year post-implantation.   "
240447|NCT01003808|"     The purpose of this study is to determine the biological recommended dose of IMF-001.   "
240448|NCT01003834|"     This is a randomized, controlled clinical trial to evaluate the effect of a computerized     screening, assessment, and brief intervention on substance use in patients recruited from a     primary care clinic. Study participants will be assigned to one of the following 4 study     groups: computerized health screening alone (standard care) (SC); computerized     assessment-only intervention (CA); computerized assessment followed by a computer-directed     motivational intervention (CACI); or computerized assessment followed by a     therapist-delivered motivational intervention (CATI). Data regarding substance use, medical     and psychosocial functioning, and economic outcomes will be collected.      The investigators hypothesize that patients randomized to CACI and CATI will be more likely     to report drug abstinence at the 3-month follow-up visit and will show greater reductions in     drug use at 1, 3 and 6 months follow-up than patients assigned to CA or SC. Similarly,     patients in the CACI and CATI groups will report greater reductions in HIV risk behaviors,     lower rates of medical and psychosocial problems, and increased economic gains at the 6-month     follow-up. In addition, patients in the assessment only intervention (CA) will have outcomes     superior to those found for SC patients. A cost-effectiveness analysis will also be done     comparing economic costs associated with CA, CACI and CATI and their relationship to     substance use reductions and related improvements in medical and psychosocial outcomes at the     6 month follow-up.   "
240449|NCT01003847|"     The investigators hypothesize that fenofibrate and fatty acid may have different metabolic     effects in hypertriglyceridemic patients   "
240450|NCT01003860|"     A comparison was made regarding opioid analgesic usage immediately after elective shoulder     replacement and for seven days at home between patients randomly given either 0.5% or 0.75%     ropivacaine via interscalene block prior to surgery.      It is hypothesized that no significant difference will exist between both groups with respect     to pain medication used in the hospital and for a 7-day period at home.   "
240451|NCT01003873|"     The aim of the study is to precise the effect of a large amount of weight loss induced by     gastric bypass on the endocannabinoid system (plasma and adipose tissue) of morbidly obese     patients and to determine the influence of a gastric bypass surgery compared to a lifestyle     intervention with equivalent weight loss on the endocannabinoid system   "
240453|NCT01003899|"     To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete     Response, Partial Response) as determined by Response Evaluation Criteria in Solid     Tumours[RECIST] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the     lung harbouring wild-type EGFR.   "
240455|NCT01003925|"     The purpose of this study is to develop a conjoint analysis-based questionnaire and decision     aid for patients with osteoarthritis of the knee and to compare the responses of two groups     of subjects, one receiving only printed information about knee osteoarthritis, the other     participating in a computer-based adaptive conjoint analysis program.   "
240456|NCT01003938|"     This is a single arm phase II study with a combination of Hycamptin® (topotecan) and     erlotinib for a minimum of 2 cycles in patients (18 yrs of age and older) with recurrent     ovarian cancer previously treated with chemotherapy drug Hycamptin® (topotecan). Up to 30     patients will be enrolled in this study.   "
240457|NCT01003951|"     Lymphedema is an accumulation of lymphatic fluid in the tissues that causes swelling, most     often in the arms and/or legs, and occasionally in other parts of the body. Lymphedema can     occur when lymph vessels are damaged or lymph nodes are removed. Lymphedema can develop right     after breast cancer treatment or weeks, months, or even years later. For many people,     available treatments for lymphedema are not effective. Recent evidence suggests that     acupuncture may help reduce the symptoms of lymphedema. The purpose of this study is to     determine the effects of acupuncture on chronic lymphedema. This study will look further at     whether acupuncture can reduce lymphedema and help us to understand immune changes that may     be associated with improvements in lymphedema.   "
240458|NCT01003964|"     The primary objective of this randomized phase II study is to compare the Response Rate of     each sequence of treatment approach in patients with advanced NSCLC. Additionally,     development of gene expression profiles and genotypes that can predict response to commonly     used chemotherapy may provide a unique opportunity to better utilize drugs shown to be     effective in first- or second-line therapy. Here, the investigators will conduct a     pharmacogenomic study to provide rational approach to the treatment of NSCLC by developing     predictors of cisplatin (first-line agent) and pemetrexed or docetaxel (second-line agents)     sensitivity and demonstrating the clinical value of identifying the most appropriate drug on     the basis of sensitivity profile for the treatment regimen of each individual patient. Such     an approach is likely to maximize response to chemotherapy and may change the current     empirical paradigm of NSCLC therapy.   "
240459|NCT01003977|"     Single center registry of patients who have received a Xience V everolimus-eluting stent at     the Washington Hospital Center, with the primary objective to assess clinical success and     safety at 30 days, 6 months and 1 year post-implantation.   "
240460|NCT01003990|"     The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected     subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS     sponsored clinical trial and to collect long-term safety information on the treated     population.   "
240461|NCT01004003|"     The study aim is to determine maximally tolerated dose (MTD) of BIBF 1120 in HCC     (hepatocellular cancer) and compare efficacy of BIBF 1120 to Sorafenib in HCC patients   "
240462|NCT01004016|"     To evaluate the efficacy and safety of KPS-0373 in patients with SCD.   "
240463|NCT01004029|"     As part of the continuing effort to study the benefit and risks of 17P and preterm delivery,     this study is designed as a multi-center, randomized, double-blind, vehicle-controlled     clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of     gestation in women with a singleton pregnancy, aged 18 years or older, with a previous     singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic     (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship     and the effect of body mass index (BMI) on the PK of 17P.   "
240464|NCT01004042|"     The primary objective of this study is to determine the alterations in quality of life and     self-steem after BOTOX® injections in the glabella in depressed and non-depressed patients.      The secondary objective of this study are:        -  to elaborate a description of the muscles involved in the Veraguth Fold        -  to evaluate depressive symptoms using Beck Depression Inventory before and after Botox®          injections.        -  to elucidate that depression is not a contraindication for botulinum toxin injections.   "
240465|NCT01004055|"     The purpose of this study is to determine whether a bioelectric wound dressing, a     silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds     resulting from curettage and electrodesiccation of skin lesions.   "
240466|NCT01004068|"     Clomiphene citrate (CC) is the first-line therapy for infertile women with polycystic ovary     syndrome (PCOS). Unfortunately, at least 20% of PCOS results are not responsive to CC.     Structured exercise training (SET) and diet has been successfully employed to restore ovarian     function and to improve reproductive outcomes in obese and overweight women with PCOS. The     current study was aimed to test the hypothesis that a short-term SET program plus diet     intervention can improve the ovarian response to CC in CC-resistant PCOS patients.   "
240467|NCT01004081|"     The purpose of this study is to assess the efficacy, safety and tolerability of 2 dosing     regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had     progressed following treatment with a nonsteroidal aromatase inhibitor (AI).   "
240468|NCT01004094|"     The primary purpose of this research is to test the effects of goal setting on fruit and     vegetable goal attainment and consumption in a 10 episode video game. Factors associated with     maintenance of behavior change will also be examined. Secondary purposes are to explore the     impact of the intervention on psychosocial factors and the home environment. 400 parent-child     pairs will be recruited for this research (800 participants total). Children will play the     video game and participate in data collection activities. Parents will receive newsletters,     have access to a healthy foods web site, and participate in data collection activities. A     small subset will be randomly selected to participate in interviews about the intervention     and its effect on the home food environment.   "
240480|NCT01004250|"     Participants with advanced non-small cell lung cancer (NSCLC) will receive a first-line     treatment of Pemetrexed, Cisplatin and Bevacizumab as induction therapy followed by a     maintenance treatment of Pemetrexed and Bevacizumab. Treatment will continue until disease     progression or unacceptable toxicity occurs. The primary objective of this study is to     measure how long this treatment could prevent the disease progression.   "
240481|NCT01004263|"     To provide long term safety data for rizatriptan in children and adolescents. The primary     hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of     acute migraine in pediatric patients age 12-17 years.   "
240470|NCT01004120|"     The traditional risk factors for obesity are inappropriate diet, lack of exercise and genetic     factors. However, recent observations have involved gut microbiota profiles as having an     additional influence. In this case, there exists the possibility to modulate this through     diet. Research has shown that the gut microbiota of both obese humans and mouse models of     obesity is altered towards less beneficial one compared to lean counterparts. This raises the     possibility of modulating the gut microbiota as a novel strategy in tackling the epidemic of     obesity and diabetes sweeping the developed world. In addition, a more direct effect of     high-fat induced disruption of the intestinal microbiota has also been seen with a murine     model. Elevated circulating levels of lipopolysaccharide (LPS) a major building block and     antigen of Gram-negative bacteria, was shown to generate a low grade chronic inflammation,     termed metabolic endotoxemia, which then onsets insulin resistance. High-fat diets were shown     to disrupt the Gram-negative intestinal populations of these animals, liberating LPS. The     effects of prebiotics on the microbiota or metabolic syndrome (combination of disorders that     increase the risk of developing cardiovascular disease and diabetes) in overweight adults     have not been investigated thus far. The investigators therefore propose to investigate the     effect of galactooligosaccharide (GOS) on the faecal microbiota and metabolic syndrome risk     factors in overweight adults in a double-blind, randomised, placebo controlled, cross-over     trial.   "
240471|NCT01004133|"     With the completion of the human genome project, investigators can now explore new questions     in human biology. Previously human genetics focused on highly penetrant, Mendelian traits;     however, now rare and common variants can be discovered that affect common diseases that     have multi-gene architecture with variable penetrance such as breast cancer, diabetes     mellitus, and coronary artery disease. This change took place because investigators now have     the tools to illuminate the whole genome at once to discover the genetic variants responsible     for different disease phenotypes through statistical differences between populations. Besides     disease phenotypes, health can be considered a human phenotype that can be studied. Health is     not merely the absence of disease but may be viewed as a dynamic ongoing interplay between     the environment and the genome to maintain homeostasis. Individuals often attempt to optimize     environmental conditions according to ones genome to maximize their health. All individuals     possess potentially beneficial and harmful variants depending on the environment. How this     dynamic interplay occurs between the genome and environment requires understanding the     boundary conditions of the genetic architecture of health and disease and then modeling the     system to simulate the observed data.      The aging process also affects health. Aging involves a loss of the normal coping responses     to internal and external environmental stressors or signals. Investigators now have the tools     to uncover from the bottom up the mechanisms involved in maintaining the ability to overcome     environmental conditions that can affect health.      Against this genomic breakthrough of whole genome association studies, the demographics in     the United States are quickly changing. The older population (age > 65 years) in 2030 is     projected to be twice as large as in 2000 representing nearly 20 percent of the total US     population. The first baby boomers turn 65 in 2011 and will challenge all facets of health     care in the coming decades. The demographic changes underscore the need to understand the     mechanisms that promote health and disease in this cohort. Genomic discoveries will help     individuals and may reduce medical costs and benefit society.      In summary, the objective of this study is to obtain blood and/or saliva samples in order to     help model health and disease phenotypes through population genomics. The blood and/or saliva     samples may allow for participants' entire genomes to be sequenced if such comprehensive     analysis becomes feasible and economical.   "
240472|NCT01004146|"     The purpose of this study is to evaluate the use of preoperative incentive spirometry (IS) as     an aid to improve postoperative lung function. The hypothesis is that application of a     standardized protocol of preoperative respiratory care teaching and exercise will improve     lung performance that will subsequently result in prevention of postoperative pulmonary     complications and that increasing the duration of preoperative use better improves lung     mechanics postoperatively. The investigators propose to compare a patient population that     uses IS as currently prescribed in the routine course of care (only to be familiar with     preoperatively, but use postoperatively) against a population that uses IS with a     standardized regimen for at least 3 days prior to the operation in terms of preoperative IS     volumes, intraoperative pulmonary mechanics, postoperative IS volumes, and incidence of     postoperative pulmonary complications.   "
240473|NCT01004159|"     This study is being performed to test if the use of high dose of cetuximab in combination     with irinotecan overcomes the resistance seen with standard dose of cetuximab plus irinotecan     in patients with wild type KRS tumors that have advanced colon or rectal cancer   "
240474|NCT01004172|"     The purpose of this research study is to determine how well the combination of bevacizumab     and carboplatin works in treating breast cancer that has spread to the brain. Bevacizumab is     an antibody (a protein that attacks a foreign substance in the body) that is made in the     laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Usually     chemotherapy drugs attack fast growing cancer cells in the body. Bevacizumab works to slow or     stop the growth of cells in cancer tumors by decreasing the blood supply to the tumors. When     the blood supply is decreased, the tumors don't get the oxygen and nutrients they need to     grow. Carboplatin is in a class of drugs known as platinum-containing compounds and has been     approved for use in the treatment of ovarian cancer. Information from other research studies     suggests that the combination of bevacizumab with carboplatin may be effective in treating     breast cancer.   "
240475|NCT01004185|"     The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and     high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg     delayed-release tablets given twice daily for 26 weeks to children and adolescents for the     maintenance of remission of ulcerative colitis.   "
240476|NCT01004198|"     MP4OX is a novel oxygen therapeutic agent specifically developed to perfuse and oxygenate     tissue at risk for ischemia and hypoxia. MP4OX is a pegylated hemoglobin-based colloid and     and as a result of its molecular size and unique oxygen dissociation characteristics, targets     oxygen delivery to ischemic tissues by selectively off-loading oxygen in tissues predisposed     to low oxygen tension. Sangart is currently evaluating MP4OX to reduce organ dysfunction and     failure in trauma patients with lactic acidosis due to severe hemorrhagic shock.   "
240477|NCT01004211|"     To date, fluorescence and narrow band imaging cystoscopy have been tested in many prospective     within patient trials but only as an add on procedure. This results in a bias that does not     allow to determine the real impact of such innovative technologies on bladder cancer     management. Hereby we propose the first prospective randomized trial which compares narrow     band imaging trans urethral resection as a stand alone procedure versus white light     transurethral resection. The primary end point is to assess the recurrence rate of bladder     cancer lesions with each treatment modality. The study is designed to disclose an inferior     recurrence rate (estimated 10%) in the group treated by narrow band imaging transurethral     resection respect to the control group, treated by standard transurethral resection.   "
240478|NCT01004224|"     The study will determine the maximum tolerated dose and thus the recommended phase II dose     and schedule of the compound and characterize the safety.   "
240482|NCT01004276|"     This pilot study will determine the feasibility of studying a new smoking cessation     management module in an existing chronic disease management system. The new module is     intended to help healthcare providers deliver more smoking cessation counselling to their     patients.   "
240483|NCT00990912|"     The purpose of this study is to determine the long term safety of patients with refractory     solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in     BMS Protocol CA124-001 or CA124-002.   "
240484|NCT00990925|"     The purpose of this study is to find out how effective lifestyle modification group therapy     is on reducing body weight when compared to usual care in individuals with schizophrenia     and/or schizoaffective disorder.   "
240485|NCT00990938|"     Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose     levels of IMO-2125 in combination with standard weight based ribavirin (investigational     treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients     will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo     and RBV arm (3 patients).   "
240486|NCT00990951|"     The purpose of this study is to evaluate the efficacy of association of Senna alexandrina     Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra     mediterranea Taub. in patients with functional constipation.   "
240487|NCT00990964|"     The purpose of the study is to assess lead implant success and complication rate using the     Medtronic Attain Family of left-heart leads and delivery catheters.   "
240488|NCT00990977|"     The number of Danish women treated for breast cancer rise every year, though survival rates     have improved, women can still expect to experience the diverse late effects reported by this     group of patients. Mindfulness labels the ability to be aware of the present moment - thereby     avoiding speculations about both past and present. Mindfulness based stress-reduction (MBSR)     is an 8-week program, covering 24 contact-hours and 45 minutes daily home practice. The     program aims at developing participants' coping resources and developing participants'     mindful awareness. Thus the program consists of guided meditations, guided body scan(a     specific awareness exercise)and through meditation, yoga and psychoeducation concerning     stress and stress-reactions, while meditation and bodyscan is practiced at home by the use of     specific audio-CDs guiding the patient. The MBSR-program have shoved promising results among     patients with anxiety-disorders, depression and chronic pain. Smaller studies have also found     positive effects of the program among cancer patients. The investigators want to evaluate the     effect of the MBSR program on levels of anxiety and depression as well as the possible     influence of mindfulness training on health behaviors and existential concerns. The study are     based on the following hypotheses:        -  report of anxiety and depression will decrease among cases        -  better compliance will lead to more decrease in levels of anxiety and depression        -  cases will make lifestyle changes suitable with recommendations for BC patients in          post-treatment phase of the illness        -  decreased level of anxiety and depression will reflect improved spiritual well-being        -  improved spiritual wellbeing will lead to decreased report of physical symptoms      All participants in this randomized controlled trial will fill out questionnaires at     enrollment and as 1, 6 and 12 months follow-up. Based on results from this trial clinicians     and patients will be able to make decisions regarding post-treatment psychosocial     intervention and researchers will have initial evidence of the effect of the intervention and     thus possible indications for research on mindfulness among patients diagnosed with cancer at     other stages or sites.   "
240489|NCT00990990|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     multiple doses of PNU-100480 given for 14 or 28 days. Killing activity against the bacterium     that causes tuberculosis (TB) will also be measured. The effect of adding an additional     tuberculosis (TB) agent (given for 2 days) in addition to PNU-100480 will be evaluated.     Linezolid open label to determine activity in whole blood assay (WBA).   "
240490|NCT00991003|"     Introduction:      Prevention of colorectal cancer (CRC) is feasible through polypectomy on screening     colonoscopy. Patient acceptance remains the main limiting factor for execution. Colon capsule     endoscopy (CCE) might be a novel method for large populations.      Aims and methods:      Patients referred for screening means or lower gastrointestinal complaints were included in     this single center pilot study. They underwent preparation and then ingested the capsule     (PillCam Colon). Standard colonoscopy was performed the next morning. Significance was     defined as polyps >5mm in size. Performance of exams was by independent physician with     blinding of results.   "
240491|NCT00991016|"     To assess the safety and tolerability of escalating single and multiple doses of the compound     in healthy volunteers   "
240492|NCT00991029|"     A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused     by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic     stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor     ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).      TIAs are common [25], and are often harbingers of disabling strokes. Approximately     250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8     years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in     fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a     prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed     transient neurological events, the true incidence of TIA may be twice as high as the rates of     diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there     were an average of 200,000 hospital admissions for TIA each year, with annual charges     climbing quickly in the period to $2.6 billion in 2003.      Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or     ischemic vascular death at 90 days.   "
240493|NCT00991042|"     The purpose of this study is to:        -  evaluate if there is an association between elevated levels of cytokines and chronic          pain due to herniated disk disease        -  measured cytokines levels in chronic low back pain and in healthy subjects.   "
240494|NCT00991055|"     The purpose of this trial is to study the efficacy and safety of pioglitazone added to     combination therapy of sulfonylurea plus metformin with placebo in patients with type 2     diabetes.   "
240495|NCT00991068|"     The purpose of the study is to explore the potential usefulness of Synera for the treatment     of pain associated with mild to moderate carpal tunnel syndrome.   "
240496|NCT00991081|"     The major purpose of this exploratory developmental study will be to develop a     patient-centered and feasible protocol for communicating genetic data as it relates to drug     efficacy for smoking cessation inpatients receiving medication that is matched to individual     genotypes associated with increased efficacy for bupropion or nicotine replacement therapy.   "
240497|NCT00991094|"     The goal of this research study is to collect information on the side effects of proton     therapy and detailed information on the proton therapy treatment plan itself so that     researchers can develop methods to predict the risk of side effects for future patients.   "
240498|NCT00991107|"     The objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of     HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and,     to assess the activity of HE3286 on insulin sensitivity and hepatic glucose production in     obese insulin-resistant adult subjects.   "
240499|NCT00991120|"     The purpose of the Extension Phase of the COMPASS-HF study is to continue to observe the     safety of the Chronicle® Implantable Hemodynamic Monitor (IHM) system and Chronicle ICD     system and provide study doctors continued access to the heart pressure information recorded     by the Chronicle devices which may be used to help manage heart failure. The Extension Phase     of the COMPASS-HF study is limited to people who have already received the investigational     system and are currently enrolled in a Chronicle IHM or ICD study.   "
240500|NCT00991133|"     This is an open-label study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase,     and Vincristine to assess this 5-drug treatment's safety and tolerability in pediatric     patients with first relapse Acute Lymphoblastic Leukemia (ALL).   "
240501|NCT00991146|"     To date there are no approved effective therapies for the treatment of cryopyrin-associated     periodic syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS),     Muckle-Wells Syndrome (MWS), or Neonatal Onset Multisystem Inflammatory Disease (NOMID) in     Japan.      The study will assess the efficacy and safety of canakinumab in Japanese patients with     cryopyrin-associated periodic syndromes (CAPS). In previous and currently ongoing CAPS     studies (CACZ885A2102, CACZ885D2201, CACZ885D2304, CACZ885D2306), it has been observed that     treatment with canakinumab in patients with CAPS contributed to ensure absence of relapse, to     improve signs and symptoms and to prevent secondary disease complications. However, no     Japanese patients have been included in those studies. This study will allow access for     Japanese patients to a new potentially efficacious treatment for CAPS patients with a     convenient dosing regimen.   "
240502|NCT00991159|"     The study is designed to determine the safety and tolerability of RN316 when administered     intravenously to healthy adult subjects. This is the first time RN316 has been given to     humans.   "
240503|NCT00991172|"     This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate     the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with     sciatic pain. Enrollment of approximately 50 patients in each of the 3 treatment arms is     expected at up to 35 US sites, for a total enrollment of approximately 150 patients. Patients     will receive 1 injection under the skin of either active or placebo REGN475, and be followed     over 10 visits for 12 weeks.   "
240504|NCT00991185|"     The purpose of this study is to learn more about antimicrobials, especially drug levels in     the CSF that would normally be used in young children as part of standard care. These drugs     are approved by the Food and Drug Administration (FDA) for treating infections. They are used     extensively in children in the United States, but they have not been extensively studied in     children or babies. The investigators do not have very much information on how children and     babies handle these drugs; that is, how long it takes for the drugs to be removed from the     blood circulation and to pass out of the body and how much goes into the central nervous     system. The investigators also do not have good information to guide how often the     investigators should give the drugs to children and babies to get the maximum effect on     infections with the minimum amount of drug. Thus, the investigators will collect more     information about how these drugs should be used in children and babies by doing this drug     levels research study.   "
240505|NCT00991198|"     This study is an evaluation of the role of topical dissolved oxygen to lessen visible signs     of photodamage using a select regimen of topical dissolved oxygen containing cosmeceutical     products. Evaluation of the overall skin tolerability of topical dissolved oxygen (safety)     utilizing the regimen of products.   "
240506|NCT00991211|"     The study addresses the question if the first line therapy of low malignant and mantle cell     lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus     rituximab with regard to progression free survival (PFS).   "
240507|NCT00991224|"     This research study is being carried out to study a new way to possibly treat HIV. T‐cells     are one of the white blood cells used by the body to fight HIV. CD8 T‐cells are a type of     T‐cell used by the body to detect and kill cells which have been infected by foreign viruses     or organisms, including the HIV virus. CD8 T‐cells must identify the HIV virus in order to     kill it. Because HIV is constantly changing the way it looks to the CD8 T‐cells, some of the     HIV virus escapes detection and is not killed by the CD8 T‐cells.      This research study uses a T cell receptor (TCR) protein specific for HIV (SL9 TCR) and adds     it to the CD8 T‐cells in the laboratory in order to help the CD8 T‐cells recognize the     constantly changing HIV virus and make it able to fight HIV more efficiently. TCR stands for     T cell receptor. TCRs are found on the surface of T cells and allow the T cells to recognize     other cells. Laboratory studies have shown that when CD8 T‐cells are modified with SL9 TCRs,     they kill cells that are infected with HIV better than normal CD8 T‐cells can. On the basis     of these laboratory results, there is the potential that SL9 TCRs may work in people infected     with HIV and improve their immune system by killing HIV infected cells and thus may help     control HIV infection.      Two different SL9 TCRs will be tested in this study, WT‐gag‐TCR and α/6‐gag‐TCR. Two     different types of SL9 TCRs are being used in this research study because the laboratory     studies suggest that the different SL9 TCRs will function differently depending on the amount     of virus in your body. A goal of this clinical study is to test the effects of infusions of     either SL9 TCR in the presence or absence of a viral load.      All subjects who receive WT‐gag‐TCR or the α/6‐gag‐TCR T cells will be enrolled in a Long     Term Follow up study to monitor subjects. Subjects will be followed every 6 months for five     years following the 1st infusion of the T cells. If the WT‐gag‐TCR or the α/6‐gag‐TCR T cells     are no longer found in the blood after five years, then subjects will be contacted yearly for     the next 10 years. If the WT‐gag‐TCR or the α/6‐gag‐TCR T cells are found in the blood at     five years after the 1st infusion of T cells, then the subjects will continue to be seen once     a year until the WT‐gag‐TCR or the α/6‐gag‐TCR T cells are no longer found in the blood for a     maximum of 15 years.   "
240508|NCT00991237|"     The purpose of the study is to evaluate the effect of PRF treatment adjacent to the lumbar     dorsal root ganglion (DRG) of L5 or S1 in patients with a chronic lumbosacral radicular     syndrome (LRS).      Prospective, single blinded, multicenter clinical trial.   "
240509|NCT00991250|"     The purpose of this study is to elucidate whether SentoClone® gives improved treatment     responses in patients with advanced malignant melanoma in comparison to established reference     treatment(s).   "
243335|NCT01040806|"     Patients with diabetes who are counseled by a peer coach (another patient with diabetes) will     have improved glycemic control compared with usual care patients.   "
240510|NCT00991263|"     RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer     may help doctors identify biomarkers related to cancer.      PURPOSE: This research study is looking at tissue samples from women treated with paclitaxel     for breast cancer on clinical trial CALGB 9344 or CALGB 9741.   "
240511|NCT00991276|"     The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole     versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.   "
240512|NCT00991289|"     Infection with hepatitis C virus (HCV) can cause liver scarring, or cirrhosis, and this     usually occurs more rapidly among people infected with both HCV and human immunodeficiency     virus (HIV). People infected with both HCV and HIV have poor response to the current HCV     treatments. This phase II pilot study evaluated whether adding a new HCV medication improves     response to the current standard HCV treatment with pegylated interferon and ribavirin in     people with both HCV and HIV.   "
240513|NCT00991302|"     Adherence to highly active antiretroviral therapy (HAART) is critical to successful treatment     of HIV. This study tested an intervention that helps people infected with HIV take all their     medications when and how they were supposed to.   "
240514|NCT00991315|"     The primary objective of this study is to collect material for study's to assess mechanisms     of tumor progression, mechanisms of resistance, isolation of stem cells and biologic markers     in tissue, serum and peripheral blood mononuclear cells.   "
240515|NCT00991328|"     The purpose of this study is to determine whether brain oxygenation measured by cerebral     oximeter has an impact on neurocognitive dysfunction.   "
240516|NCT00991341|"     The RECESS study will compare the effects of transfusing red blood cell units stored <= 10     days vs. red blood cell units stored >= 21 days, in patients who are undergoing complex     cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis     is that there is a clinically important difference between the effects of shorter-storage red     cell units and longer-storage red cell units on clinical outcomes and mortality risk.   "
240517|NCT00991354|"     An effective vaccine may be the only way to stop the HIV pandemic. The purpose of this study     is to determine the safety of and immune response to the DNA vaccine, PENNVAX-B with or     without an IL-12 adjuvant when given using electroporation.   "
240518|NCT00991367|"     The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort)     usage in the treatment of recent post-surgical scars. The duration of this double-blind     placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of persons to     be recruited and randomized for the study is 90.   "
240519|NCT00991380|"     The investigators aim to establish the effectiveness of a prescribed, community-based     lifestyle modification program for those with recently diagnosed diabetes. The investigators     hypothesize that those who enter a 6 month program will report greater levels of physical     activity compared to a group who do not enter the program but who continue to receive usual     care.   "
240520|NCT00991393|"     The purpose of this research study is to shorten the treatment time course for patients who     are scheduled for surgery to have a sinus lift and dental implant(s) placed into the upper     front part of their mouth, and need to have more bone in their jaws and a thicker sinus floor     to support the implant.   "
240521|NCT00991406|"     The purpose of this research is to find the optimal patterns of functional electrical     stimulation (FES) of muscles in the lower legs that will improve walking ability in those who     have had a stroke and at the same time ensure walking stability. FES involves applying small     electric currents to the nerves, which cause the muscles to contract.      FES research projects vary from simple investigations of the therapeutic effects of exercise     on muscle function and skin health, to more complex studies of functional movements such as     standing or walking.   "
240522|NCT00991419|"     The purpose of this study is to compare PET measurements of fibrillar amyloid burden using     [18F]AZD4694.   "
240523|NCT00991432|"     The purpose of this research study is to determine whether this study treatment can improve     the bone structure of the upper front part of the jaw in patients who are scheduled for     surgery to have a dental implant(s) placed into the upper front part of their mouths and need     to have more bone in their jaws to support the implant, so that a dental implant can later be     inserted.   "
240524|NCT00991445|"     The purpose of this study is to determine whether Minimal Invasive Surgery results in less     postoperative pain and better mobilization than conventional technique in Unicompartmental     Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.   "
240525|NCT00991458|"     This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops     administered twice daily before and following LASIK surgery.   "
240526|NCT00991471|"     The primary objective of this study is to investigate whether the introduction of a     physician-nurse supplementary triage assessment team (MDRN STAT) is effective in improving     time-based performance indicators for wait times. Secondary objectives will examine the     quality of patient care and health care worker satisfaction and the cost-effectiveness of the     program   "
240527|NCT00991484|"     Analysis of collagen subtype subcutaneously and genetic analysis of patients from families     with a tendency to hernias. Furthermore circulating biomarkers and biomarkers extracted from     the subcutaneously tissue such as MMP's (matrix metallo proteinases) and TIMP's (tissue     inhibitor of metallo proteinases) will be measured.   "
240528|NCT00991497|"     The purpose of this study is to compare the results of foam treatment of varicose veins (foam     sclerotherapy) in patients who wear compression bandages for 24 hours or 5 days after     treatment.   "
240529|NCT00991510|"     The purpose of the study is to further investigate how much of the drug substance     mycophenolate mofetil can be found in the blood of patients with kidney or renal     transplants when treated with Myfenax® or CellCept®. Additionally, the safety and side     effects of the two products will be compared. All information already available on these     products indicates that the safety profiles of the two products will be the same.   "
240530|NCT00991523|"     The purpose of this study is to examine the effects of post-exercise protein ingestion prior     to sleep on overnight protein kinetics and muscle recovery.   "
241543|NCT01012947|"     This study was based on baseline data derived from a large prospective study called the Suwon     Project (SP), a cohort comprising random clustering samples of elderly people, all of whom     are ethnic Koreans aged over 60 years.   "
240531|NCT00991536|"     Quality of sleep is profoundly affected in patients with hypercapnic respiratory failure and     restrictive disorders, with a decrease in rapid eye movement (REM) and slow wave sleep, and     an increase in sleep fragmentation. Assisted ventilation aims at improving blood gases, but     may also have a favorable impact on sleep structure. The investigators reviewed     polysomnographic and blood gas data obtained between 1987 and 2008 in 95 patients with     restrictive pulmonary disorders, before and after implementing non-invasive ventilatory     support.   "
240532|NCT00991549|"     This study compared the efficacy at one year of an interdisciplinary approach including     individual counseling and group seminars versus group seminars alone to induce weight loss in     subjects at high risk of developing type 2 diabetes.      This study also compare if a participant's presence in small informative meeting groups as     the only form of intervention is sufficient to induce a lifestyle change, thus inducing the     weight loss needed for the prevention of the diseases associated with obesity.   "
240533|NCT00991562|"     The purpose of this study is to test IMGN901 in combination with lenalidomide and     dexamethasone every 28 days.   "
240534|NCT00991575|"     The main purpose of this study is to investigate progression of late complications of     diabetes during the last ten years in a well characterized cohort of type 1 diabetes with a     long duration of the disease, and to define factors responsible for the progression of late     complications.   "
240535|NCT00996892|"     This is an open-label, multicenter, Phase Ib dose-escalation study designed to assess the     safety, tolerability and pharmacokinetics of oral dosing of cobimetinib and pictilisib     administered in combination in patients with locally advanced or metastatic solid tumors.   "
240536|NCT00996905|"     Ultrasound scanning of the back has been shown to increase success when used to guide     epidural catheter insertion. However, this technique is not applied widely in clinical     practice. Stronger evidence is required to prove that it will improve the clinical experience     of labour epidurals.      The study hypothesis is that anesthesiologists (both residents and fellows), will have an     increased rate of success and ease of insertion of labour epidural catheters, and that there     will be increased patient satisfaction, if ultrasound scanning of the lumbar spine is done     prior to the procedure.   "
240537|NCT00996918|"     The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab     in subjects with Alzheimer Disease who participated in study 3133K1-3000 (NCT00667810). Over     250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each     subject's participation will last approximately 4 years.   "
240538|NCT00996931|"     The purpose of this study is to determine if lenalidomide (Revlimid®)reduces proinflammatory     cytokines including TNF-alpha and may actually alter the clinical course of autism for some     children.   "
240539|NCT00996944|"     This is a multicenter, placebo controlled, parallel group, double-blind, randomized     comparison study to evaluate the efficacy and safety of ropinirole IR tablets orally     administered for 12 weeks in patients with symptomatic restless legs syndrome associated with     Chronic kidney disease (CKD) managed with haemodialysis (including haemofiltration and     haemodiafiltration) (hereinafter referred to as uRLS), to evaluate the efficacy and safety     of long-term administration of ropinirole IR tablets, and assess the effect on the steady     state pharmacokinetics in the long-term administration period of ropinirole IR tablets.   "
240540|NCT00996957|"     For cancer cells to grow, they need to have nutrients supplied to them through blood vessels.     The study drug, ACE-041, is designed to work by blocking the growth of those blood vessels     and preventing cancer cells from growing. The purpose of this study is to establish safe dose     levels of ACE-041 in patients with advanced solid tumors or relapsed/refractory multiple     myeloma following multiple dose administration. This study will also evaluate if ACE-041 has     an effect on tumors.   "
240541|NCT00996970|"     The purpose of this research is to determine the effectiveness of the novel H1Nl influenza     (inactivated/killed formulation) vaccine among both HIV-infected and HIV-uninfected persons.     The administration of the H1Nl vaccination is not part of the study's procedures, but is     being given as part of routine care.   "
240542|NCT00996983|"     Neuropathic pain is difficult to control because it is only partially sensitive to opioid     analgesics, and requires the addition of other therapies such as antidepressants and     epileptics. Ziconotide is a drug that is used to treat neuropathic pain in patients who have     had inadequate pain control with prior combination of medicines.   "
240543|NCT00996996|"     This is a single-arm, single-institution, phase II study of Iodine-131 Anti-B1 Antibody for     patients with previously untreated, advanced-stage (stage III or IV) low-grade non-Hodgkin's     B-cell lymphoma. A total of 75-80 patients will be enrolled.      Patients will undergo two phases of the study. In the first phase, termed the dosimetric     dose, patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 70     minutes (including a 10-minute flush) immediately followed by a 30-minute infusion (including     a 10-minute flush) of Anti-B1 Antibody (35 mg) which has been trace-labeled with 5 mCi of     Iodine-131. Whole body gamma camera scans will be obtained 5 to 8 times between Days 0 and 7     following the dosimetric dose. Using the dosimetric data from 3 imaging timepoints (the     imaging timepoints to be used in decreasing order of preference depending on availability of     data are Days 0, 3, and 7; Days 0, 4, and 7; Days 0, 3 and 6; Days 0, 4, and 6; Days 0, 2,     and 7; and Days 0, 2, and 6), a patient-specific dose of Iodine- 131 to deliver the desired     total body dose of radiotherapy will be calculated. In the second phase, termed the     therapeutic dose, patients will receive a 70-minute infusion (including a 10-minute flush)     of unlabeled Anti-B1 Antibody (450 mg) immediately followed by a 30-minute infusion     (including a 10-minute flush) of Anti-B1 Antibody (35 mg) labeled with the patient-specific     dose of Iodine-131 to deliver a whole body dose of 75 cGy. Patients who are obese will be     dosed based upon 137% of their calculated lean body mass. Patients will be treated with     either saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide     tablets starting at least 24 hours prior to the first infusion of the Iodine-131 Anti-B1     Antibody (i.e., dosimetric dose) and continuing for 14 days following the last infusion of     Iodine-131 Anti-B1 Antibody (i.e., therapeutic dose).      The primary endpoint of the study is the determination of the response rate with Iodine-131     Anti-B1 Antibody in previously untreated patients with low-grade non-Hodgkin's lymphoma     (NHL). The secondary endpoints include duration of response, safety, radiation dosimetry, and     the predictive value of detection of the presence or absence minimal residual disease by     molecular techniques on response duration.   "
240544|NCT00997009|"     This study aims to assess the activity of a combination of cetuximab (weekly) with     carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of     event-free survival (EFS).   "
240545|NCT00997022|"     This Phase I study of sorafenib in high risk hepatocellular cancer patients after liver     transplantation will study 24 subjects for about 5 years. Each subject will receive sorafenib     for 6 months. Safety and effectiveness on the post transplant, high risk HCC patients will be     studied.   "
240546|NCT00997035|"     The purpose of this study is to determine if the addition of oral voriconazole to topical     treatment regimens results in lower rates of perforation in severe fungal corneal ulcers.   "
241544|NCT01012960|"     The purpose of this study is to evaluate if opioid-induced effects on the pharynx and     esophagus is centrally or peripherally mediated.   "
240601|NCT01004705|"     This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the     cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril)     as compared to the effect on LDL cholesterol of simvastatin given alone. Approximately 76     subjects will be screened, 60 randomized in order about 52 subjects to finish the study.   "
240547|NCT00997048|"     A pilonidal sinus is a cyst or abscess near or on the natal cleft of the buttocks that often     contains hair and skin debris. The condition is common and requires surgery to be cured.     Several surgical procedures are described in literature. The most common surgical procedure     in Sweden is excision of the sinus followed by suturing the subcutaneous tissue and skin.     This method, however, has some problems regarding healing and recidives. Therefore this study     is comparing the standard excision procedure to another surgical procedure, laying open.     Healing frequency is the main variable, but postoperative pain, sick leave time and patient     satisfaction is also measured.   "
240548|NCT00997061|"     The registry is an international, multicenter, observational registry of newly diagnosed     patients with SCLC.      Data will be entered into an electronic CRF (eCRF) via Internet access. Treatment plan     remains the responsibility of the patient's physician and data collected in this registry     will reflect a real world approach of the diagnosis and treatment of patients with SCLC.      Approximately 60 centres in 13 countries will take part in this registry. It is expected that     about 500 patients will be recruited during a period of 6 to 9 months according to the     feasibility.   "
240549|NCT00997074|"     In the current study, we want to evaluate the prophylactic use of ibuprofen versus a placebo     for medical abortion by mifepristone and misoprostol, at a gestational age of up to 7 weeks,     in regard to the effect on pain relief and the overall procedure success.      expected results:      The prophylactic use of NSAIDs could offer significant pain relief and thereby a reduction in     the need for additional pain relievers compared to the placebo, without interfering with the     outcome of medical abortion   "
240550|NCT00997087|"     The purpose of this study is to evaluate the efficacy of flumazenil in the outpatient     treatment of Obsessive Compulsive Disorder (OCD).   "
240551|NCT00997100|"     This is an exploratory open label single arm study to evaluate changes in disease activity     and biomarkers in patients with mild active SLE, during treatment with ABR-215757 given as     add-on to standard therapy. To be eligible for the study SLE patients should present with     symptoms from skin, mouth and/or joints. After a screening period of one week patients will     be treated with ABR-215757 for 12 weeks. The initial dose of ABR-215757 will be 1.5 mg/day.     There will be an option to increase the dose to 3.0 mg/day following 28 days of treatment.     Follow-up visits will take place 4 weeks and 8 weeks after last day of treatment. Disease     activity during treatment will be studied using the Systemic Lupus Erythematosus disease     Activity Index (SLEDAI-2K) as well as organ system specific disease activity indexes (CLASI     for skin involvement and number of swollen/tender joints using 28- and 66/68-joint counts).     At specified time points during the study, blood samples and biopsies will be collected for     analysis of established and exploratory biomarkers of SLE. Concomitant SLE treatment allowed     include: prednisolone or equivalent at a dose of ≤15 mg/day, hydroxychloroquine,     azathioprine, methotrexate and mycophenolate mofetil, all at stable doses from specified     timepoints prior to the study and throughout the study.   "
240552|NCT00997113|"     This is a randomized clinical trial of deep procedural sedation with propofol with and     without supplemental alfentanil. Patients will be assessed for total and fractionated serum     catecholamines before and after the procedure in addition to usual procedural sedation     outcomes parameters to assess the adrenergic effect of propofol sedation without supplemental     opioid.   "
240553|NCT00997126|"     This is a clinical trial of propofol and alfentanil as agents for moderated procedural     sedation in patients undergoing sedation in the emergency department (ED).   "
240554|NCT00997139|"     Staphylococcus aureus, a bacteria that lives commonly in the anterior nostrils, is seen in     about 30% of healthcare workers. Applying mupirocin ointment, a prescription, to the nostrils     twice daily for 5 days is the current standard of care for treatment to clear this bacteria.     This research study is designed to determine the rate of clearance of this bacteria in     healthcare workers who are carriers when using triple antibiotic ointment instead of     mupirocin ointment.   "
240555|NCT00997152|"     The purpose of this study is to evaluate the effect of JTT-654 on diabetes as well as the     safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.   "
240556|NCT00997165|"     The NUMEVOX cohort is intended to follow-up the macro and microvascular dysfunction in     relation to adipose tissue repartition in patients with metabolic syndrome associated to     liver steatosis, sleep apnea. Duration of the follow-up is 3 years for each patient entering     the cohort.   "
240557|NCT00997178|"     The primary aim of the study is to determine if non-surgical periodontal therapy (scaling and     root planing and supportive periodontal therapy) is efficacious compared to delayed therapy     in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in     subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis.      The secondary aims of the study are to:        1. evaluate whether 6 month (or shorter-term (3 month)) changes in clinical measures of          chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical          attachment level) are related to changes in HbA1c and fasting glucose or insulin          resistance as measured by the Homeostasis Model Assessment 2 (HOMA2).        2. assess the 3 month and 6 month efficacy of periodontal therapy on all of the above study          outcomes. If a treatment response is observed for any of the study outcomes at 3 months,          then the trial can evaluate whether this response is sustained at 6 months.   "
240558|NCT00997191|"     Intravitreal triamcinolone has been effective for central macular thickness reduction and     concomitant visual acuity improvement in patients with diabetic macular edema (DME). VEGF is     a very effective inducer of permeability, being 50.000 times more potent than histamine, and     may exert its effect on retinal vascular permeability by altering tight-junctions proteins,     such as occluding and VE-cadherin. Based on these principles, there is a rationale for     anti-VEGF agents treatment of increased retinal capillary permeability conditions, such as     diabetic macular edema. Therefore, the purpose of this study is to evaluate the effects of     intravitreal bevacizumab and intravitreal triamcinolone associated to laser photocoagulation     for diabetic macular edema.   "
240559|NCT00997204|"     This study is being conducted to explore the clinical safety, local tolerability, convenience     and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous     injections of icatibant.   "
241545|NCT01012973|"     To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into     the eye on vision function in subjects with macular edema as a consequence of central retinal     vein occlusion   "
240560|NCT00997217|"     Perioperative myocardial injury is a serious complication of cardiac surgery. This     complication increases both mortality and morbidity of cardiac surgery. Remote ischemic     preconditioning (RIPC) is the concept that brief ischemia followed by reperfusion in an organ     can reduce subsequent ischemia-reperfusion injury in distant organs. Recent several clinical     trials showed powerful myocardial protective effect of remote ischemic preconditioning by     reducing postoperative cardiac enzymes. However, the evidence that remote ischemic     preconditioning can improve the clinical outcomes such as mortality and morbidity, is still     lacking. The investigators perform a multicenter randomized controlled study to evaluate that     remote ischemic preconditioning can improve the outcomes of cardiac surgery.   "
240561|NCT00997230|"     The primary objective of the study is to collect epidemiological data on EGFR mutation status     (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation     status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc).     In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in     patients with clinico-pathological characteristics that are not commonly associated with EGFR     mutation positivity (i.e., smokers, men, and non-adenocarcinoma).   "
240562|NCT00997243|"     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as lintuzumab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal     antibodies may be a better way to block cancer growth.      PURPOSE: This phase II trial is studying the side effects and how well giving azacitidine     together with lintuzumab works in treating patients with previously untreated myelodysplastic     syndromes.   "
240563|NCT00997256|"     To demonstrate the influence of a herbal preparation containing hypericum, passionflower, and     valerian on sleep structure, improvement of attention, and well-being in comparison to     placebo.   "
240564|NCT00997269|"     This study will investigate whether a supplement called co-enzyme Q10 can help ease or     eliminate some of the side effects that result from taking statin medications. These side     effects include muscle pain, fatigue or muscle cramping.   "
240565|NCT00997282|"     The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262     (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a     double-blind fashion and to evaluate the safety of OPC-262 to placebo.   "
240566|NCT00997295|"     The aim of the present study was to measure the inspired gas temperature and humidity of the     anesthetic circuit in the Dräger Primus machine and esophageal temperature with or without     and heat and moisture exchanger (HME) and low-flow gas during anesthesia in patients     submitted to gynecological surgeries.   "
240567|NCT00997308|"     This study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of two     doses of AZD1446 or placebo in subjects when given for 4 weeks.   "
240568|NCT00997321|"     This study is a clinical trial of moderate sedation with propofol versus moderate sedation     with ketamine for procedural sedation in the Emergency Department.   "
240569|NCT00997334|"     Erlotinib is a drug which targets non small cell lung cancer with a genetic change (mutation)     in the epidermal growth factor receptor (EGFR). This drug has been used in other cancer     research studies and information from those studies suggests that Erlotinib can control the     growth of these cancer cells.   "
240570|NCT00997347|"     This open-label, comparative study will compare the efficacy, safety, and acceptability of     200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual     misoprostol for termination of pregnancy in existing outpatient early medical abortion     services among women 57-63 days' versus 64-70 days' gestation.   "
240571|NCT00997360|"     This is an open label dose escalation study to find the maximum tolerated dose (MTD) of     PKI-179 in subjects with solid tumors. Part 1 of the study will be the dose estimation phase     and will be open to subjects with all solid tumors. Part 2 will be the dose confirmation     phase and will be open to subjects with breast, non small cell lung, ovarian, endometrial, or     colorectal cancer or glioblastoma. All subjects will receive daily oral dosing of PKI-179. A     continuous reassessment method (CRM) design will be used, which will take into account dose     limiting toxicity (DLT) information from each dose level explored in order to determine the     next dose level.   "
240572|NCT00997373|"     Some cases of endometrial cancer are dependent on estrogen for their growth. Letrozole blocks     estrogen production in the body. The purpose of this study is to determine if the     investigators can predict which patients might benefit from Letrozole treatment by studying     the many different forms of the estrogen receptor molecule that exist within the cancer     tissues. To participate in this study, the patients must be 40 years of age or older and have     biopsy-proven endometrial carcinoma, either well differentiated or moderately differentiated     forms. Also, to be eligible to participate in this study, the patients need to be healthy     enough to have a hysterectomy. If the patients are less than age 60, they will need a blood     test (FSH) to confirm that they have gone into menopause.   "
240573|NCT00997386|"     The purpose of this study is to look at whether the combination of lower-dose chemotherapy     with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody     medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so     that those cells take hold and build a healthy new blood cell factory after transplant. The     study will also look at the safety of the combination of drugs and of the transplant of     peripheral blood stem cells from a healthy relative or an unrelated donor.   "
240584|NCT01004406|"     The purpose of this randomized, multi-site, clinical trial is to determine whether intensive     therapy consisting of cholesterol-lowering statin drugs plus apheresis to cleanse the blood     of low-density lipoprotein (LDL) cholesterol is more effective than statin therapy alone in     reducing plaque volume in heart arteries of patients who have already suffered an acute     coronary syndrome (ACS). The study will also investigate whether this intensive approach can     help increase the presence of endothelial progenitor cells (EPC), stem cells that have been     shown to reduce CV events in ACS patients. This study has II phases and FDA approval for     phase II has been received.   "
240574|NCT00997399|"     Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel     cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC     inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients     with solid tumors and hematological malignancies.      To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with     solid tumors and hematological malignancies participating in several phase I/II clinical     studies. Panobinostat PK does not appear to be different in patients with solid tumors and     hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is     yet to be elucidated.      Kidney and liver are involved in the elimination and metabolism of panobinostat. The current     study is designed to evaluate the impact of renal function status on panobinostat PK.   "
240575|NCT01004289|"     The POST-conditioning during coronary angioplasty in Acute Myocardial Infarction (POST-AMI)     trial will evaluate the usefulness of postconditioning in limiting infarct size and     microvascular damage during the early and late phases after AMI.   "
240576|NCT01004302|"     Up to 40% of Obsessive-Compulsive Disorder (OCD) patients do not respond to conventional     treatments (medications or behavior therapy). For some of them, a neurosurgical treatment can     be indicated. Among various surgical techniques, Gamma Knife radiosurgery has the advantage     of not requiring the production of burr hole openings in the skull. However, there are no     randomized controlled trials of radiosurgical procedures.      The investigators' aim is to investigate whether radiosurgery for the treatment of severe and     refractory OCD is efficacious and safe, by a double-blind, randomized controlled trial.     Forty-eight refractory OCD patients will be randomized into two different groups: the first     one will receive standard radiosurgery; the second group will be submitted to a false     radiosurgery (sham operation). Patients who had been previously submitted to sham surgery     will be able to undergo real operations after one year of follow-up, when blinding is broken.     For a minimum period of one year, patients will be periodically followed-up in terms of     psychiatric changes (including OCD symptoms), global functioning, cognitive/personality     changes and neuroimaging findings.   "
240577|NCT01004315|"     To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.   "
240578|NCT01004328|"     The incidence of drug-induced injury is high in the ambulatory geriatric population,     especially for elders with complex healthcare needs during high risk transitions to the     ambulatory setting. In a previous study funded by the National Institute on Aging and the     Agency for Healthcare Research and Quality [AHRQ] (AG 15979), the investigators determined     that drug-related injuries occur at a rate of more than 50 per 1000-patient years in older     adults in the ambulatory setting and that 28% are preventable. Independent risk factors for     adverse drug events among older adults in the ambulatory setting included advanced age,     multiple comorbid conditions, and the use of medications requiring close monitoring. In this     project, Using HIT to Improve Transitions of Complex Elderly Patients from SNF to Home (1 R18     HS017817), the investigators are testing the use of an electronic medical record (EMR)-based     transitional care intervention for complex elderly patients transitioning from subacute care     in a skilled nursing facility (SNF) to the ambulatory setting. The growing trend for     physicians and other healthcare providers to restrict their practices to single settings and     not follow complex patients as they move between settings leaves older patients discharged     from subacute care particularly vulnerable. This transition is uniquely challenging because     of the complex healthcare needs of this population, who often require outpatient primary care     physicians to coordinate with visiting nurses in order to manage complex medication regimens     and fluctuating clinical status. To facilitate high-quality transitions from the subacute to     the ambulatory setting and support interdisciplinary communication, the investigators will     use the EMR to assure that physicians in the ambulatory setting receive key health     information and alerts.   "
240579|NCT01004341|"     The purpose of this study is to evaluate the role of different parenting skills and parenting     styles in the success of children enrolled in a family-based behavioral weight control     program and to compare these skills and styles to those used by families with normal weight     children.   "
240580|NCT01004354|"     Children and adolescents with psychiatric illnesses who are treated with medications called     second generation antipsychotic agents (SGA) often gain excessive weight during their     treatment with these medications. This weight gain may result in the development of features     of the metabolic syndrome or frank diabetes mellitus. There is no consensus on the best way     to prevent these complications. The investigators' hypothesis is that daily vitamin D     supplementation in these patients will result in decreased levels of the markers of metabolic     syndrome with associated reduction in waist circumference.   "
240581|NCT01004367|"     Worldwide, low-income and middle-income countries are undergoing rapid demographic and     nutritional changes. Populations tend to move from their traditional food habits towards     dietary patterns characterized by a more energy-dense diet, while urbanization and technology     (work, transport) play a role in the reduction of their physical activity. This shift towards     energy-dense diets and lower levels of physical activity are key determinants of chronic     diseases. Nowadays, childhood overweight and obesity are becoming a major threat to public     health all in low-income and middle-income countries. Clearly, not properly addressing this     health problem will only aggravate the already enormous impact of chronic diseases on the     social and economic development of these countries. This study aims to develop a culturally     relevant school-based prevention intervention among Ecuadorian adolescents (11-13 years old)     in Cuenca. The intervention will target behavioural nutrition and physical activity.     Intervention strategies will be developed based on theoretical behavioural change models     integrated in two complementary frameworks, i.e. (i) the Intervention Mapping protocol, and     (ii) the Comprehensive Participatory Planning and Evaluation protocol.      The study includes two phases:        1. A formative research, which will be conducted in order to understand the causality of          the school environment and unhealthy eating and low physical activity levels in          school-going adolescents, aged 12-13 years old.        2. A paired, cluster-randomized controlled trial including 1400 adolescents (12-13 years          old) from 10 pairs of schools (i.e. clusters). Within each pair of clusters, one cluster          will be randomly assigned to the intervention and the other to the control group.   "
240582|NCT01004380|"     The purpose of this study is to evaluate whether combination therapy with farletuzumab     (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.   "
240586|NCT01004432|"     The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid     arthritis (RA) participants who have an inadequate response to their current treatment with     either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50     milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of     upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also     designed to evaluate the benefit and safety of switching participants from treatment with     golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram     per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a     marked improvement of their RA at Week 16.   "
240587|NCT01004445|"     This study is part of a research program too see if amikacin delivered as an aerosol directly     to the lungs in combination with IV antibiotic therapy can help intubated patients with     gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The     primary purpose of this study is to determine the correct dose of amikacin which is delivered     directly to the lungs as an aerosol via an investigational device called the Pulmonary     Delivery Device System (PDDS).   "
240588|NCT01004458|"     Previous studies have shown that the disorder fibromyalgia often is preceded by long-term     stress. Moreover, an association has been shown between stress, pain and co-morbidity in     these patients. Cognitive behavioral therapy (CBT) has been shown effective in reducing     stress, anxiety and pain in rheumatoid arthritis and fibromyalgia. The purpose of the present     trial was to assess whether CBT may reduce pain and other symptoms and increase well-being     and general function, affect biological markers for pain and long-term stress, to a larger     extent than treatment as usual.      Forty eight women with verified fibromyalgia were randomly allocated to an early treatment     group or a waiting list group. The early treatment group received CBT group treatment during     six months. Measurements of outcome and potential outcome affecting variables were made at     baseline, after six months and one year after baseline. The waiting list group received the     same CBT treatment as the early treatment group after six months on the waiting list.      The design is thus a traditional waiting list design, allowing a two parallel group     comparison during the first six months and a before-after analysis in both groups when the     treatment was concluded.   "
240589|NCT01004471|"     The purpose of this exploratory study is to determine the effect of a prototype nasal dilator     strip on nasal resistance during sleep in subjects who complain of chronic, nocturnal     congestion and have trouble with their sleep.   "
240590|NCT01004484|"     Hypothesis:        -  Daily consumption of yogurt containing probiotic bacteria (Bb12) and inulin will          significantly decrease whole gut and intestinal segmental transit time        -  The effect of accelerating intestinal transit will be associated with other GI          physiology parameters including stool frequency and stool consistency.   "
240591|NCT01004497|"     The main aim of the present study is to evaluate the clinical efficacy of first-line     dasatinib plus conventional chemotherapy for newly diagnosed Ph-positive acute lymphoblastic     leukemia. In this study, the investigators will analyze the clinical outcomes for entire     patient population as well as those for transplants, respectively. In addition, the results     of this study will be compared to those of the investigators current study (imatinib plus     conventional chemotherapy). The safety of this treatment will also be studied.   "
240592|NCT01004510|"     The purpose of this study is to evaluate whether the addition of the bisphosphonate Zometa     (zoledronic acid) used along with standard regimens of chemotherapy, will help to control the     need for palliative intervention of malignant pleural effusions due to non-small cell lung     cancer.   "
240593|NCT01004523|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients will respond to     treatment.      PURPOSE: This research study is looking at tissue and blood samples from patients with     low-grade glioma.   "
240594|NCT01004536|"     Silicone gel is a self-drying silicone polymer that forms thin film after application onto     the skin. Because silicone film is a medical device, silicone gel is also regarded as a     medical device. Silicone gel has been on the market for many years for the management of scar     in the phase of treatment as well as in the phase of prevention. In contrast to other methods     that are expensive, invasive or inconvenient, silicone gel is convenient, non-invasive and     also reasonably priced. However, the number of well-designed clinicial trials for efficacy     and safety are not enough to provide robust evidences in making clinical decisions for scar     management options. In a prospective, multi-center, investigator-blind randomized half-split     study for patients undergoing cesarean sections, the investigators attempt to provide valid     information for the efficacy and safety of silicone gel in the prevention phase of scar.   "
240595|NCT01004549|"     This study will determine the ability of three different intraocular lenses to accommodate in     patients who have previously undergone bilateral intraocular lens implantation.   "
240596|NCT01004562|"     RATIONALE: Collecting and storing information from patients with cancer to study in the     future may help doctors learn more about cancer.      PURPOSE: This study is collecting information from patients enrolled in the Breast     Specialized Program of Research Excellence.   "
240597|NCT01004575|"     The purpose of this study is to assess whether the new Kaname coronary stent is safe and     effective for the treatment of patients with coronary artery disease.   "
240598|NCT01004588|"     The main objective of this study is to examine the effects of resistance type exercise     training combined with nutritional support on body composition and muscle characteristics in     healthy elderly men and women. For a comprehensive insight into the potential underlying     mechanisms of the intervention effects on whole body-, muscle- and myocellular level, a broad     range of tests will be performed before, during, and after the intervention period.   "
240599|NCT01004601|"     Docetaxel and pemetrexed have been validated for previously treated advanced non-small cell     lung cancer (NSCLC); however, tolerability is a concern with the docetaxel (tri-weekly 75     mg/m2 schedule). The investigators conducted this study to compare the efficacy and toxicity     of weekly low-dose docetaxel versus tri-weekly pemetrexed for previously treated advanced     NSCLC.   "
240600|NCT01004614|"     This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD)     tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are     bioequivalent.   "
240602|NCT01004718|"     RATIONALE: Imaging procedures, such as positron emission tomography or computed tomography,     may help in detecting differences between Hodgkin lymphoma or diffuse large B-cell lymphoma     cancer cells. PURPOSE: This clinical trial is studying positron emission tomogaphy and     computed tomography in determining differences in Hodgkin lymphoma and diffuse large B-cell     lymphoma.   "
240603|NCT01004731|"     The objective is to evaluate the toxicity profile, response rate, and time to progression of     Cetuximab administered in combination with either Carboplatin + Gemcitabine in patients with     advanced non-small cell lung cancer with positive EGFr expression.   "
240604|NCT01004744|"     The purpose of this study is to determine the feasibility of a short term administration of a     targeted therapy (i.e., anastrozole) in women with newly diagnosed early invasive or non     invasive breast cancer during the interval between their breast biopsy and surgery.     Anastrozole is a form of hormonal therapy which is part of the standard treatment for hormone     sensitive breast cancer in postmenopausal women. This clinical model is being used to     evaluate the biologic effects of this drug on a specific molecular pathway called the     PI3K/AKT signaling pathway.   "
240605|NCT01004757|"     Compared to the traditional low fat diet for overweight patients with type 2 diabetes, recent     evidence shows that low carbohydrate/high protein diets lower triglycerides and postprandial     glucose levels more effectively. However, it is not known, whether this diet can also improve     the subclinically impaired myocardial function in type 2 diabetes. This prospective parallel     group and cross over design study compares the effects of a low glycemic and insulinemic diet     (LOGI®) with an isocaloric traditional low fat diet during a three weeks rehabilitation     programme with aerobic exercise for overweight type 2 diabetes patients testing the     hypothesis, that the low carbohydrate diet improves myocardial function and insulin     resistance.   "
240606|NCT01004770|"     This is a non-randomized dose-escalating study that will evaluate the safety and tolerability     of GE-145 at four different dose levels through the assessment of clinical laboratories,     vital signs, physical examinations, electrocardiograms (ECGs) and the frequency and intensity     of adverse events (AEs). It will characterize the pharmacokinetic properties of GE-145     through the evaluation of serum and urine. It will evaluate the radiographic density in     regions of interest (ROI) and the overall diagnostic quality following administration of     GE-145.   "
240607|NCT01004783|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This clinical trial studies biomarkers in tumor tissue samples from young patients     with very low risk Wilms tumors.   "
240608|NCT01004796|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is looking at tissue samples from patients with breast cancer.   "
240609|NCT01004809|"     Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in     Korean androgenetic alopecia patients   "
240610|NCT01004822|"     The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable when     given as weekly infusions to adult patients with advanced solid tumors.   "
240611|NCT01004835|"     The objective of this study is to obtain blood or saliva samples to define genes for migraine     and pain diseases.   "
240612|NCT01004848|"     The purpose of this study is to compare the effectiveness of a peer-led community-based     lifestyle intervention, versus usual care, in achieving weight loss and prevention of     diabetes among overweight adults with pre-diabetes in East Harlem.   "
240613|NCT01004861|"     PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary     objective of this study is to evaluate the safety and pharmacokinetics of orally administered     PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are     linked to disease pathophysiology. The secondary objective is to measure the pharmacodynamic     activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.   "
240614|NCT01004874|"     This is a phase II study of the combination of radiation therapy, temozolomide and Avastin     followed by Avastin, temozolomide, and topotecan in grade IV malignant glioma patients.   "
240615|NCT01004887|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients will respond to     treatment.      PURPOSE: This research study is looking at tissue and blood samples from patients with     high-grade glioma.   "
240616|NCT01004900|"     Glaucoma affects 66 million people worldwide and is the leading cause of irreversible     blindness, and Primary angle-closure glaucoma (PACG) is a major form of glaucoma in Asia.      Laser peripheral iridotomy (LPI) has been advocated as the first line treatment in all cases     of PACG. In addition to relieving the relative pupil block element of the condition, it can     open up the drainage angle, alleviating appositional and synechial angle-closure and in the     long-term this may control intraocular pressure (IOP) and prevent progression of glaucomatous     optic neuropathy. However recent data indicate that iridotomy is not successful in     controlling IOP in the long term, and the majority of cases develop a clinically significant     rise in IOP requiring medical therapy or surgery.      Laser trabeculoplasty has been a recognized treatment option for Primary open angle glaucoma     (POAG) since the 1980s. Recently a more selective and less destructive method of performing     laser trabeculoplasty has evolved. Selective Laser Trabeculoplasty (SLT) specifically targets     the pigmented trabecular meshwork cells without producing collateral damage and destruction     to adjacent structures. Morphologic study performed on human autopsy eyes treated with SLT     noted no structural or collateral thermal damage to the trabecular beams in the uveal and     corneoscleral meshwork. As SLT specifically has its effect on the targeted pigmented     trabecular meshwork it is unlikely to generate PAS. It may be a useful treatment option for     PACG patients in whom the angle has widened following laser peripheral iridotomy.      The proposed study is a randomized controlled trial to assess the effectiveness of SLT in     reducing IOP in cases of PACG in which the angle has opened up following LPI, but IOP remains     high(>21 mmHg). 100 subjects will be randomized to receive either SLT or medical treatment to     achieve IOP control. They will be followed up for 6 months.   "
241336|NCT01019681|"     The purpose of this study is to determine whether treatment with umbilical cord blood stem     cells will improve blood flow to the most severely affected leg of a participant with     medically refractory and non-surgical peripheral vascular disease of the lower extremity.   "
240793|NCT01000272|"     The purpose of this study is to determine whether inflammatory bowel disease in children     involve the respiratory tract as expressed by increased levels of the Fraction of exhaled     Nitric Oxide (FeNO) and spirometry.   "
240617|NCT01004913|"     Benign Paroxysmal Positional Vertigo (BPPV) is the most frequent cause of vertigo of     peripheral vestibular origin with life time incidence of 2.4%. BPPV is characterized by bouts     of acute whirling vertigo lasting less than one minute provoked by changes in head position     in relation to the gravitational vector. The vertigo is accompanied by typical rotational or     horizontal nystagmus that is often demonstrated by the Dix-Hallpike maneuver and less     frequently by testing for positional nystagmus. BPPV pathogenesis is currently explained by     the fall of otoconia (calcium-carbonate crystals) or otoconial debris from the tectorial     membrane of the otolithic organs into the dependant semicircular canals (canalithiasis) or     adherence of such particles to the semicircular canal's cupula (cupulithiasis). Under these     circumstances, the semicircular canal which normally responds only to angular velocity and     acceleration is stimulated by gravity. Otoconial remnants as free floating particles inside     the semicircular canal arms or attached to the cupula have been observed by few     investigators. Although the presence of such particles explains most characteristics of the     positioning nystagmus described in BPPV, it does not account for the dizziness and     disequilibrium which are described by many patients even without changes in head position and     the continuation of such symptoms after successful treatment of BPPV as evidenced by the     resolution of positional vertigo and nystagmus.      The study hypothesis is that otolithic pathology is an important component in the     pathogenesis of BPPV explaining these symptoms, BPPV recurrence, and the refractoriness of     some BPPV cases to the vastly employed particles repositioning treatments. In the present     study the Vestibular Evoked Myogenic Potentials (VEMP) testing would be employed to measure     the function of one of the otolithic organs - the saccule. The study objectives are: 1. To     investigate possible malfunction of the saccule in patients suffering from BPPV. 2. To look     for association between saccular pathology and BPPV recurrence and between such pathology and     BPPV treatment failure. 3. To study possible relation between saccular pathology and     continuation of dizziness and disequilibrium despite the resolution of positional vertigo.   "
240618|NCT01004926|"     The aim of this work was to test the Echelon foot efficiency to offer enhanced safety,     comfort and function over a wide range of walking surfaces, inclines and stairs, thereby     improving the quality of life for amputees.      Ten individuals with a unilateral trans- tibial amputation will participate in two test     sessions- one while using their own prosthetic foot, the other while using the Echelon foot.   "
240619|NCT01004939|"     The objective of this retrospective study is to gather information about how fondaparinux is     used pre-, peri- and/or postpartum for both the prophylaxis and treatment of venous     thromboembolism (VTE) in order to fill an information gap concerning the off-label use of     fondaparinux during pregnancy.   "
240620|NCT01004952|"     The purpose of this study is to understand how people make decisions about sun protection.     This study is important in helping to protect against sun exposure, since it is a main risk     factor for melanoma. The investigators would like to understand the decisions people make     about sun protection so that they can improve their ability to help individuals who may be at     risk for melanoma.   "
240621|NCT01004965|"     This research study is looking at bone marrow and blood samples in patients with untreated     acute myeloid leukemia or acute lymphoblastic leukemia enrolled on clinical trial CALGB-9621,     CALGB-9720, CALGB 19808, and CALGB 10201. Studying samples of bone marrow and blood from     patients with cancer in the laboratory may help doctors learn more about changes that occur     in DNA and identify biomarkers related to cancer. It may also help doctors predict how     patients will respond to treatment.   "
240623|NCT01004991|"     This is a phase I/II open label, multi-center study of azacytidine in combination with     standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at     escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on     day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion     will then evaluate efficacy of the combination at the established MTD.   "
240624|NCT01005004|"     The purpose of this study is to determine the safety and preliminary effectiveness of human     central nervous system stem cells (HuCNS-SC®) transplantation in patients with Connatal     Pelizaeus-Merzbacher Disease (PMD).   "
240625|NCT01005017|"     Chronic pancreatitis is a progressive inflammatory disease resulting in slow destruction of     the pancreas. This chronic inflammation can lead to chronic abdominal pain which can last for     many years. Unfortunately, medical management often is of only limited benefit in treating     the pain of chronic pancreatitis.      Management of patients with intractable pain is difficult, often resulting in narcotic     addiction.      Early results in a small group of patients suggest that percutaneous radiofrequent lesioning     of splanchnic nerves has good potential for pain control in a subset of patients with chronic     pancreatitis. Given the simplicity of the procedure, it clearly warrants reappraisal to     identify its current role in pancreatic pain management.   "
240626|NCT01005030|"     The primary objective of the study is to determine the utility of blood plasma infrared     spectroscopy (biospectroscopy) in distinguishing subjects with idiopathic Parkinson's disease     from healthy controls.   "
240627|NCT01005043|"     The primary objectives of this trial are the determination of feasibility and toxicity of     Heavy Ion Radiotherapy (C12) in patients with non-resectable osteosarcoma. Secondary     endpoints are tumor response, disease free survival and overall survival. The aim is to     improve outcome for patients with non-resectable osteosarcoma.   "
240628|NCT01005056|"     The purpose of this study is to evaluate the efficacy and safety of Marvelon® in the     prevention of pregnancy.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
240629|NCT01005069|"     The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the     management of subjects with type-II-diabetes mellitus and to determine the minimal effective     dose of DLBS 32 for subjects with type-II-diabetes mellitus.   "
240822|NCT01000662|"     All patients (with Stages 0-II breast cancer) will receive an accelerated three week regimen     of prone whole breast radiotherapy. The study intends to test the hypothesis that a weekly     boost to the tumor bed, delivered on Friday, before the weekend break, is as well tolerated     as the daily boost during accelerated prone radiotherapy.   "
240630|NCT01005082|"     Randomized clinical trial comparing water therapy plus low-salt diet to water therapy alone     in patients affected by idiopathic calcium nephrolithiasis.      Treatment duration: three months Primary end-point: correction of hypercalciuria Main     inclusion criteria: calcium stone formers with idiopathic hypercalciuria, with at least one     stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (>300     mg/day in males and >200 mg/day in females); 18-65 years.      Main exclusion criteria: primary hyperparathyroidism, primary hyperoxaluria, enteric     hyperoxaluria, bowel resection, inflammatory bowel disease, renal tubular acidosis,     sarcoidosis, sponge kidney, hyperthyroidism, use of hypercalciuric drugs such as Vitamin D,     acetazolamide, anti-epileptic drugs   "
240631|NCT01005095|"     The investigators hypothesize that vitamin D supplementation may ameliorate interferon     beta-induced flu-like symptoms, owing to reduced release and activity of the cytokines that     are in correlation with this adverse event. Vitamin D supplementation may also positively     affect injection site reactions due to its immunomodulatory effects. Vitamin D may also     augment the therapeutic efficacy of interferon beta among multiple sclerosis (MS) patients.     Vitamin D intake may influence melatonin levels of MS patients as they share the same nuclear     receptor.   "
240632|NCT01005108|"     Overall Objectives: The overarching goal is to compare the effectiveness of acupuncture and     gabapentin to their respective placebo controls in the treatment of hot flashes in breast     cancer patients. The investigators primary specific aim will focus on determining the     magnitude of response to placebo acupuncture versus placebo pills on hot flashes (HFs).   "
240633|NCT01005121|"     Patients with diabetic nephropathy and proteinuria, despite maximal anti- hypertensive and     anti-glucose treatment, will receive colchicine for six months, 2 mg a day, during which     their 24 hour urine protein and renal function tests will be monitored. The investigators'     hypothesis is that colchicine will diminish proteinuria and might also help slow down the     development of end stage renal failure in the long run.   "
240634|NCT01005147|"     The investigators hypothesize that addition of Tranexamic acid, an antifibrinolytic agent, to     conventional therapy will lead to an improved outcome characterized by lower transfusion     requirements.   "
240635|NCT01005160|"     The purpose of this study is to evaluate safety, tolerance by comparing availability and the     pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone     and combination to healthy male volunteers.   "
240636|NCT01005173|"     This study is a non-intervention, multicenter study to address biomarkers of acetaminophen     toxicity in children. Specifically, the study will examine acetaminophen (APAP) protein     adducts and markers of liver injury in the blood samples of hospitalized children and     adolescents who are receiving standard doses of acetaminophen, and children and adolescents     who are status post acetaminophen overdose. Ultimately, the data generated from this study     will be used to establish second generation biomarkers of acetaminophen toxicity, based on     specific adduct proteins, which can be used in future risk assessment studies of children     receiving acetaminophen.   "
240637|NCT01005186|"     A lifestyle intervention aimed at improving exercise levels in primary school children.   "
240638|NCT01005199|"     RATIONALE: Sorafenib tosylate and everolimus may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This randomized phase II trial is studying giving sorafenib tosylate together with     everolimus to see how well it works compared with sorafenib tosylate alone in treating     patients with localized, unresectable, or metastatic liver cancer.   "
240639|NCT01005212|"     This study will be a cross-sectional survey of interobserver variability associated with     contrast enhanced ultrasound (CEUS) to detect endoleaks using computed tomographic     angiography (CTA) as the practice standard. The investigators will enroll 40 consecutive     patients undergoing endovascular abdominal aortic aneurysm repair (EVAR). At the first     follow-up visit after the procedure, participants will undergo two abdominal ultrasound     examinations with and without contrast, and one CTA. Analyses will be conducted to examine     interobserver variability in the detection and characterization of endoleaks using     contrast-enhanced ultrasound (CEUS). Other endpoints include examination of sensitivity and     specificity of CEUS compared to CTA, and characterization of the number and types of     endoleaks detected.   "
240640|NCT01005225|"     The objective of this study is to obtain blood samples, solid tumor and/or benign hyperplasia     samples to learn more about genetic differences that are linked to the formation of solid     tumors.   "
240641|NCT01005238|"     The aim of this randomized clinical study is to show non-inferiority of a change of     anti-viral therapy from telbivudine to lamivudine in patients who have achieved an     undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment     with telbivudine with respect to the viral breakthrough rate at week 108 as the primary     clinical outcome.   "
240642|NCT01005251|"     This study is being carried out to see whether AZD3355 is an effective treatment as an add-on     to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial     response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another     goal of the study is to examine which of the investigated doses of AZD3355 is optimal for     treatment of these patients. This study will also measure levels of drug in the blood and see     how well it is tolerated.   "
240643|NCT01005264|"     1. Objective: To evaluate the efficacy of removable cast walker compared to non-removable          fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer        2. Research design and methods: Forty-five adult diabetic patients with non-ischemic,          non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable          fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment          duration was 90 days. Percent reduction in ulcer surface area and total healing rates          were evaluated after treatment.   "
240644|NCT01005277|"     RATIONALE: Studying samples of DNA from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research study is looking at biomarkers in DNA samples from patients with acute     lymphoblastic leukemia or acute myeloid leukemia.   "
240645|NCT01005290|"     The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given     together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and     ramipril) to the effect on systolic pressure of ramipril given alone.   "
240646|NCT01005303|"     There is some evidence to suggest that patients with heart failure may have a reduced dietary     intake of vitamins and essential minerals (micronutrients) and that this may worsen the     function of the heart. This study is designed to investigate if supplementation with     micronutrients (including high−dose vitamin D) will improve the function of the heart in     patients with heart failure.   "
240647|NCT01005316|"     The purpose of this study is to determine the clinical outcomes of sensitized pediatric heart     transplant recipients with a positive donor-specific cytotoxicity crossmatch and to compare     this group with outcomes in nonsensitized heart transplant recipients.   "
240648|NCT01005329|"     This phase II trial is studying the side effects of giving intensity-modulated radiation     therapy together with cisplatin and bevacizumab followed by carboplatin and cisplatin and to     see how well it works in treating patients who have undergone surgery for high-risk     endometrial cancer. Specialized radiation therapy that delivers a high dose of radiation     directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs     used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Giving intensity-modulated     radiation therapy together with chemotherapy and bevacizumab after surgery may kill any tumor     cells that remain after surgery.   "
240649|NCT01005342|"     The aim of this study is to        -  Measure the effect on gene expression in leukocytes from a meal rich in oat bran        -  Investigate the postprandial glucose, insulin and triglyceride responses after intake of          meals containing fiber from different sources (oat, rye and sugar beet fiber) or a meal          containing a mixture of these three fibers   "
240650|NCT01005355|"     This trial is testing the investigational drug IMC-1121B administered to Japanese     participants with advanced solid tumors who have not responded to standard therapy or for     whom no standard therapy is available. The rationale for performing this trial is to     establish the safety profile and the pharmacokinetics of IMC-1121B.   "
240651|NCT01005368|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research study is looking at biomarkers in blood and bone marrow samples from     patients with previously untreated chronic lymphocytic leukemia.   "
240652|NCT01005381|"     This study has two research arms:      The purpose of the 1st is to determine if a smaller particle size calcium carbonate     supplement (than that which is now commercially available) improves calcium absorption and     retention in adolescents girls.      The purpose of the 2nd is to determine if vitamin D supplementation improves calcium     absorption and retention in adolescents girls.   "
240653|NCT01005394|"     The past 10 years of research in persons more than 6 months post stroke have shown certain     types of rehabilitation can help re-wire the brain. Transcranial magnetic stimulation (TMS)     can be used to monitor this re-wiring by mapping the brain's function (measuring brain     activity). Recent research suggests that TMS can be used for both prognosis (determining     future function) and to determine what type of rehabilitation therapy will work best after     stroke. The purposes of this research study are to: 1) determine changes in brain activity     during the first 6 months after stroke (to determine how the brain re-wires); 2) compare     changes in recovery of motor function with changes in brain re-wiring; 3) determine the     ability of TMS to predict functional outcome in the first 6 months after stroke.      The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as     measure motor threshold (MT), motor evoked potentials (MEPs) and recruitment curves; 2)     baseline TMS will predict future functional outcomes at 3 and 6 months.   "
240655|NCT01005420|"     The purpose of this study is to evaluate the effect of blueberry powder on insulin     sensitivity in obese, non-diabetic, and insulin resistant subjects. The investigators     hypothesized that supplementation with blueberry powder will result in an increase in insulin     sensitivity in obese subjects with insulin resistance.   "
240656|NCT01005433|"     Regional anesthesia has become the anesthetic of choice for cesarean section in most     countries; however, some women still prefer general anesthesia techniques. There are many     trials for the pharmacological modifications of the sympathetic response to surgery,     including opioids, tenoxicam, ketorolac, lidocaine and paracetamol. However, opioid     administration to the mother before delivery has adverse neonatal effects. This research is a     novel trial on the use of dexmedetomidine for suppression of the hemodynamic and hormonal     responses of cesarean delivery.   "
240657|NCT01005446|"     The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder     Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a     total shoulder replacement (primary and revision subjects).   "
240658|NCT01005459|"     The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for     CSE labor analgesia volume will last a significantly longer period of time that that of     spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects     meeting criteria when analgesia is requested will be randomized to receive a combined     spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or     bupivacaine 2 mg with fentanyl and epinephrine.   "
240659|NCT01005472|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with     sunitinib malate may kill more tumor cells.      Phase II was never conducted due to toxicity in phase I.      PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib malate     when given together with temozolomide and to see how well they work in treating patients with     stage III or stage IV malignant melanoma.   "
240663|NCT01005524|"     The main objective of this study is to evaluate the usability of a system to assist verbal     communication based on BCI system using the P300 wave in patients with tetraplegia who can no     longer communicate because of severe engine damage (tetraplegia) and respiratory damage     requiring invasive mechanical ventilation (intubation or tracheostomy) preventing verbal     communication.   "
240773|NCT01006967|"     The investigators are conducting a multi-central randomized prospective trial comparing a     standard physical therapy gait and balance program with a gait and balance program that     includes the ActiveStep™ treadmill.      Subjects will be randomized to either have the ActiveStep™ as part of their therapy or to     have their therapy without it. Data will be gathered from session notes, medical records and     short interviews with the subjects at baseline and every 3 months over the telephone for the     duration of the study.   "
240664|NCT01005537|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Biological therapy, such as cellular adoptive immunotherapy using autologous     lymphocytes, may stimulate the immune system in different ways and stop tumor cells from     growing. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Giving     cyclophosphamide together with autologous lymphocytes and aldesleukin may be an effective     treatment for metastatic melanoma.      PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide     together with autologous lymphocytes and aldesleukin and to see how well it works in treating     patients with metastatic melanoma.   "
240665|NCT01005550|"     This is a prospective, monocentric, randomized study, comparing the effectiveness and     tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal     anaesthesia during traumatic femoral neck surgery in the elderly.   "
240666|NCT01005563|"     The primary aims of this study are to assess the effects of habitual dietary protein intakes     across the acceptable macronutrient distribution range with lean beef/pork or soy/legumes as     the predominate sources of protein on indices of daily appetite and mood, and on postprandial     appetite, mood, energy expenditure, and glycemic responses during energy-restricted weight     loss in overweight adults.   "
240667|NCT01005576|"     This study is being done to determine if blood cell transplants, with either bone marrow or     cord blood from unrelated donors, are effective in children with severe thalassemia and if     this treatment approach has acceptable risks and side effects.      This study includes a preparative regimen with Hydroxyurea, Alemtuzumab, Fludarabine,     Thiotepa and Melphalan that provides intense host immunosuppression without myeloablation.     The primary hypothesis is that this regimen will promote stable engraftment of unrelated     donor hematopoietic cells, support normal erythropoiesis, and result in an event free     survival of > 75% of children with thalassemia major.   "
240668|NCT01005589|"     Bacterial infections are a major cause of death in newborn infants. And are linked to     complications including: sepsis (an over exaggerated immune response to infection) and     necrotising enterocolitis (a potentially fatal inflammatory bowel disease).      Detecting infections at an early stage is difficult in newborns as the signs and symptoms can     be non-specific, the most commonly used lab test is to culture a sample of blood, urine or     spinal fluid to try and grow and identify any bacteria that is present; however these tests     take 24-48 hours to give results, and this means that neonates who present with signs of     infection are prescribed broad spectrum antibiotics whilst results are obtained.      The lack of a test that can detect infection at an early stage and give rapid results is one     of the major problems in the diagnosis and management of infection in newborns. This study     will investigate neutrophils, which are white blood cells that are important in fighting     infection. When neutrophils detect and infection they become activated, and produce a protein     called CD64 (a cell marker) on their surface, and it is this protein that we want to measure.     Neutrophils produce the CD64 protein within 1 hour of first detecting an infection, so we     could hopefully detect and treat infections much quicker.      The hypothesis this study will test are:        1. Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker          of infection in neonates AND:        2. Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker          of NEC in neonates   "
240669|NCT01005602|"     Dosing methods for digoxin, a drug used to treat heart failure, have not been updated in     decades despite evidence in recent years suggesting that blood levels of digoxin achieved     with traditional dosing practices may increase the risk of adverse events. We developed a     simple dosing tool that targets lower blood levels of digoxin that have been associated with     improved outcomes compared to higher blood levels. The aim of this study is to determine if     this simplified dosing tool is more effective than standard digoxin dosing practices at     achieving lower blood levels and also to determine if digoxin dosing may be further optimized     by incorporating patients' genetic information believed to influence the drug's properties.   "
240670|NCT01005615|"     To determine whether functional electrical stimulation (FES) promotes neurological and     physical recovery in patients with spinal cord injury (SCI).      The researchers will investigate the extent of functional recovery in patients with spinal     cord injury who receive functional electrical stimulation in the upper extremities compared     with patients who do not receive FES.   "
240671|NCT01005628|"     After the KFDA (Korea Food and Drug Administration) approval of a new drug, an annual report     of the drug's safety and efficacy data must be reported to the Health Authority in 6 years.     In this Observational study, we will investigate the basic demographic, medical history,     concomitant drug use, as well as dosing information of multiple myeloma patients using     bortezomib (Velcade).   "
240672|NCT01005641|"     Aromatase inhibitors are the standard treatment for hormone responsive advanced breast     cancer. The combination of the aromatase inhibitor exemestane with with another breast cancer     drug that blocks epidermal growth factor receptor (EGFR) and Erb-2 activity (lapatinib) is     being studied for the possibility of improving response to therapy, and delaying resistance     to endocrine therapy.   "
240741|NCT01006551|"     This is an open trial of ziprasidone (ZIP) in children and adolescents. It is designed to     provide pilot data on the magnitude of ZIP's antipsychotic effects in psychotic youth, dosing     ranges, acute safety, and tolerability. This would then inform the design of a rigorous,     randomized controlled trial of ZIP in the pediatric population. The primary study hypothesis     is that the proportion of pediatric subjects responding to treatment with ziprasidone will be     comparable or greater than reported in trials of ziprasidone in adults.   "
240742|NCT01006564|"     To determine if functional MRI methods will aid planning of a radiation dose boost within the     prostate in patients with prostate cancer potentially improving safety and efficacy.   "
240823|NCT01000675|"     The current proposal describes a post-market, clinical registry of HydroSoft, aimed at     gaining robust clinical data in a large set of patients to better define the advantages, and     potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.   "
240792|NCT01000259|"     This research study is looking at tumor tissue samples from patients who have undergone     surgery for advanced stage III or stage IV ovarian epithelial cancer. Studying samples of     tumor tissue from patients with cancer in the laboratory may help doctors learn how tumor     infiltrating T cells can predict how patients will respond to treatment.   "
240673|NCT01005654|"     Background:        -  Endocrine neoplasms (tumors) are among the fastest growing tumors in incidence in the          United States. Furthermore, it is often difficult to distinguish between benign or          malignant tumors in cancers of the thyroid, parathyroid, adrenal gland, and pancreas.          More research is needed to improve detection and treatment options for patients who          develop these kinds of cancer.        -  Researchers are interested in studying the molecular changes that are involved in          endocrine cancer development and growth. To collect a sample of tumor specimens and          healthy tissue for further study, researchers are specifically looking for samples from          patients who are scheduled for surgery or biopsy on endocrine tumors.      Objectives:      - To collect samples of precancerous, cancerous, and healthy tissue from individuals who are     scheduled for surgery or biopsy of endocrine system tumors.      Eligibility:      - Individuals who have a tumor in or around their thyroid, parathyroid, adrenal gland,     pancreas, or any neuroendocrine tissue, and are scheduled for surgery at the National     Institutes of Health Clinical Center.      Design:        -  Participants in this study will provide blood and urine samples prior to surgery.        -  During the surgery or biopsy, pieces of the tumor or precancerous growth and pieces of          normal tissue near to the tumor will be removed for ongoing and future research. The          rest of the tumor or growth will be sent for analysis.        -  After surgery, participants will receive routine care until discharge, and doctors will          discuss possible treatment options. If there is an appropriate NIH protocol,          participants may choose to be treated at the NIH.        -  After discharge, participants will return to the clinic for a routine postoperative          check about 6 weeks following the operation, and then may be followed yearly at the          Clinical Center or by phone.   "
240674|NCT01005667|"     The purpose of this study is to test the hypothesis that using the BirthTrack for management     of labor shortens the time to delivery and thus improves both maternal and perinatal     outcomes.   "
240675|NCT01005680|"     The purpose of this study is to compare the efficacy and safety of two different chemotherapy     types in the first line treatment of advanced Non-Small Cell Lung Cancer (NSCLC).   "
240676|NCT01005693|"     RATIONALE: Questionnaires that measure how well older patients think, learn, remember, and     make judgments and carry out daily activities may improve the ability to plan treatment for     patients with cancer.      PURPOSE: This clinical trial is studying testing for fitness to undergo chemotherapy to see     how well it works in predicting treatment outcomes in older patients with cancer.   "
240677|NCT01005706|"     This study's focus is to compare the level effectiveness and safety of regimens involving     Sirolimus, Cellcept and steroid to Prograf, Sirolimus and steroid in African-American     recipients of kidney transplants.   "
240678|NCT01005719|"     This study will determine differences between Proton Pump Inhibitors (PPI) formulations     relative to their effects on gastric acidity.   "
240679|NCT01005732|"     Purpose - To determine the effectiveness of custom-fit pressure garment therapy in the     prevention of hypertrophic scarring in healed burns.      Background - Approximately one million people are burned each year in the United States. The     most devastating outcomes following burns is the ugly, itchy, hypertrophic scar that     interferes with work and all other aspects of life. Pressure garment therapy is routinely     used to minimize hypertrophic scarring even though there is no scientifically valid data that     this therapy is efficacious. Pressure garments are extremely unattractive, expensive and     uncomfortable and their use needs to be based upon valid data.      Goals and Objectives - The investigators plan to determine the effectiveness of pressure     garment therapy in the control of hypertrophic scarring in healed burns.      Methods - The I-Scan® device was designed to measure pressure at the body/environment     interface and allows clinicians to deal with pressure-related problems for at-risk patients.     It has been widely used in rehabilitation medicine but not with burn survivors. The     investigators will use this device to measure the pressure at the garment/skin interface. 2)     Furthermore, the few studies that have been attempted to determine efficacy have used between     subjects designs. Since burn depth is extremely variable from patient to patient and since     hypertrophic scarring is greatly influenced by age and race/origin, the between subjects     design requires very large numbers of subjects. The investigators will use a within wounds     design studying forearm burns and applying pressure to half of the wound and no pressure to     the other half. The investigators will then compare hardness, color, thickness and clinical     appearance.   "
240680|NCT01005745|"     The overall purpose of this research study is to find a better way to treat melanoma. This     will be a single arm exploratory trial to evaluate prospectively the feasibility of, the     toxicities of, and the persistence of TIL which can survive in vivo.   "
240681|NCT01005758|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects of combination chemotherapy and to     see how well it works in treating adult patients with newly diagnosed acute lymphoblastic     leukemia.   "
240682|NCT01005771|"     This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.   "
240683|NCT01005784|"     This is a comparison of pregnancy achievement between two GnRH antagonist protocols which     differ in the timing of GnRH antagonist initiation.   "
240684|NCT01005797|"     The purpose of this study is to determine if a new investigational drug called Panobinostat     is safe, tolerable and to obtain an initial assessment of efficacy, when given in combination     with Sorafenib for the treatment of certain types of lung cancer, kidney cancer and soft     tissue sarcoma.   "
240685|NCT01005810|"     This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will     reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is     hypothesized that marijuana dependent adolescents who are treated with NAC will use less     marijuana during treatment when compared to adolescents who receive a placebo.   "
240686|NCT01005823|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7     days treatment with LEO 29102 in adult patients with atopic dermatitis.   "
240743|NCT01006577|"     Primary hypothesis: Side-to-end anastomosis is non-inferior to colon J pouch for     reconstruction after low anterior resection for rectal cancer in fecal incontinence (Wexner     score).      Research questions: Are there differences between side-to-end anastomosis and colon J pouch     in        -  bowel function (fecal incontinence, frequency of bowel movements, rectal urgency,          incomplete evacuation)        -  quality of life        -  sexual function        -  urinary function        -  postoperative complications        -  operation time/ institutional costs   "
240744|NCT01006590|"     The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration     of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a     submaximal dose of metformin.   "
240745|NCT01006603|"     This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride     in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on     metformin monotherapy.   "
240687|NCT01005836|"     Structured, manualized treatments have been developed for numerous mental health problems and     disorders among children and adolescents, and a number of these have shown strong beneficial     effects in clinical trials. Such findings have led to proposals that the empirically     supported treatments be used to improve outcomes of conventional clinic treatment, which some     research suggests may not be very effective. But can these lab-tested treatments actually     work in service-oriented clinics with referred youth? Available evidence cannot tell us,     because the therapists, conditions, and clientele in the laboratory efficacy tests tend to     differ so markedly from those of clinical practice. To assess the clinical potential of     efficacy-tested treatments, we need effectiveness research that tests these treatments in the     crucible of clinical practice. To help begin this process, the proposed research focuses on a     specific treatment program for a specific cluster of disorders: Kendall's (1994)     cognitive-behavioral Coping Cat program for child and adolescent anxiety disorders. The     program has shown unusually positive effects across a series of clinical trials in the U.S.     and Australia, but it has never been tested in real-world clinical conditions. The proposed     study will test the effectiveness of the treatment with clinic-referred youth, treated in     community clinics, with the treatment carried out by clinic staff therapists. Some 128 youth,     aged 9-14, referred for anxiety and diagnosed with anxiety disorders, will be randomly     assigned to receive either the usual treatment in the clinic, or the Kendall program, carried     out by clinic staff who have been trained to proficiency. Therapists for the two treatment     conditions will also be chosen randomly, from a pool of volunteers. Outcome assessment at     immediate post-treatment, 1-year, and 2-year follow-ups, will test effects across many     outcomes. It is hypothesized that outcomes for youths treated using the cognitive-behavioral     treatment will be superior to those treated using usual care.   "
240688|NCT01005849|"     The present study is designed to evaluate the effect of a mixture of probiotics on the     prevention of traveler's diarrhea (TD) in subjects who travel to a country with a high risk     for developing TD. Subjects will be asked to take one capsule containing a mixture of     probiotics or a placebo capsule a day, within the week before departure, during the travel     and up to 3 days after return. They will note the following outcomes in a diary: occurence of     diarrhea, number and consistency of stools, duration of the diarrhea, presence of     diarrhea-related symptoms and need for rescue medication.      The present study will examine if the use of the probiotics capsule reduces the occurence of     traveler's diarrhea as compared to the placebo capsule.   "
240689|NCT01005862|"     The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of     ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and     healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365,     pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and     tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease     and healthy volunteers.   "
240690|NCT01005875|"     This study is to determine the safety and efficacy of stereotactic body radiotherapy (SBRT)     and treatment drug in patients with hepatocellular carcinoma.   "
240691|NCT01005888|"     The study objective was to determine the safety and efficacy of C1INH-nf for the prevention     of acute HAE attacks.   "
240692|NCT01005901|"     A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients     with moderate-to-severe chronic obstructive pulmonary disease (COPD).   "
240693|NCT01005914|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase II trial is studying the side effects of giving pegaspargase together     with combination chemotherapy and to see how well it works in treating patients with newly     diagnosed acute lymphoblastic leukemia.   "
240694|NCT01005927|"     Fructooligosaccharides (FOS) are believed to have positive effects on calcium absorption and     bone accrual during growth. This study aims to see whether the addition of fiber in the form     of FOS to a calcium-containing beverage will increase calcium absorption. During two clinical     visits, participants will receive a beverage containing a small amount of calcium,     supplemented with either no dietary fiber or a small amount of fiber. Height, weight, bone     density and geometry, calcium absorption, and physical fitness will be measured. The effects     of this fiber intervention may provide support for improving bone health with minimal fiber     supplementation.   "
240695|NCT01005940|"     This study is being done to see if treatment of obstructive sleep apnea (OSA) with a     mandibular advancement device (MAD) shows an increase in the quality of life. Many patients     prefer to call them mandibular advancers, jaw advancers, jaw advancement splints, jaw     advancement devices, anti-snoring mouthpieces, or oral appliances for the treatment of     snoring and mild to moderate obstructive sleep apnea. The investigators will also see how     helpful the mandibular advancement device is on insulin resistance.   "
240696|NCT01005953|"     As the prevalence of autism spectrum disorders continues to rise and the shortage of special     education resources becomes more dramatic, the need for electronic tools that reduce the time     burden of implementing an individual education plan (IEP) with pencil and paper methods     becomes more apparent. SymTrend is going to expand its Internet and mobile     computer/phone-based system for 1) collecting behavior data, 2) charting progress, 3)     creating forms for #1 and #2, and 4) communicating within the IEP team, to include digital     pen technology. Although this system will be tested with monitoring lower functioning     children with autism, it has immediate relevance to a wide range of special education, mental     health, and medical applications. The hypothesis is that this digital pen-based system will     save time and money in the education of children on the spectrum and will enhance     communication between schools and families.   "
240697|NCT01005966|"     This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial     caries lesions in an in situ model   "
240698|NCT01005979|"     The purpose of this study is to determine the maximum tolerated dose (MTD), safety and     toxicity when cyclophosphamide, rituximab and lenalidomide (Revlimid) are combined for the     treatment of relapsed/refractory of chronic lymphocytic leukemia (CLL) and small lymphocytic     lymphoma (SLL).   "
240699|NCT01005992|"     The aim of our study is to determine the effect of fractional photothermolysis laser in the     treatment of burn scars.   "
240700|NCT01006005|"     The study is recruiting 50 patients initiating or switching to Atripla and comparing them to     250 individuals previously followed in a prospective study of HIV+ low income individuals     recruited from homeless shelters, single room occupancy hotels and free meal food lines as     part of the UCSF Reach Study. Adherence will be measured through monthly unannounced pill     counts and electronic medication monitors.   "
240701|NCT01006018|"     To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or     without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and     insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.   "
240702|NCT01006031|"     Objective: To evaluate the efficacy and safety of high doses of both peginterferon-alfa 2a     (360 ug per week) plus ribavirin (800 mg b.i.d.) in HIV-infected patients with compensated     liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard     dose treatment of both drugs.      (*) Non previous virological response: no decrease of plasma RNA-HCV at least 2 log10 after     12 weeks in treatment or breakthrough viremia while on treatment.      Additionally, this study will evaluated the influence of simultaneous peginterferon-alfa 2a     and ribavirin plasma concentrations on early viral response (EVR) and sustained viral     response (SVR) in these patients.      Method: Pilot clinical trial, phase II-III, open labeled multicenter in which patients from     several hospitals of the Servicio Andaluz de Salud will be enrolled.      The usual clinical and analytical follow up will be performed but additional blood samples     will be obtained for determination of interferon and ribavirin plasma levels. The primary end     point will be a sustained virologic response (defined as an undetectable serum HCV-RNA after     24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks     of treatment), early virological response (at 12 weeks), and end of treatment response rates     will be evaluated as well as their relationships with the plasma interferon an ribavirin     concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the     studied medications will be evaluated by means of clinical adverse events, physical     examination and laboratory results. The evolution of liver fibrosis will be evaluated     comparing the basal and end of treatment results of transient elastometry.   "
240703|NCT01006044|"     1. Primary outcome measure:           a.Evaluation of the treatment impact on progression-free survival.        2. Secondary outcome measures:             1. Safety evaluation.                  -  Direct effects attributable cell obtaining and administration.                  -  Adverse events during treatment.                  -  Neurological deterioration quantified using the NIH Stroke Scale.                  -  Autoimmune phenomena.             2. Evaluation of impact on other efficiency clinical parameters.                  -  Overall survival.                  -  Quality of life measured with EORTC questionnaire.             3. Study of specific immune response and correlates with clinical outcome.                  -  Delayed hypersensitivity.                  -  Humoral response to autologous tumor cells/tumoral lysate.                  -  Cellular response (proliferation, cytokine production, specific cytotoxicity).             4. Cell line characterization and correlate the final product with clinical efficacy.                  -  Phenotypic studies.   "
240704|NCT01006057|"     This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the     NN1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent     that the dose should be adjusted in subjects with impaired renal function compared to the     dose for subjects with normal renal function.   "
240705|NCT01006070|"     The purpose of this study is to create a prospective database of patients with myeloma     affecting the spine. This database will define changes in health-related quality of life over     time, and the effect of incident fractures and their treatment on specific measures of pain,     physical function, pulmonary function, and future fractures. In 2008, the UCSF Myeloma     Service was actively caring for 347 patients with myeloma, of which 150 patients had lytic     lesions on radiographs, and 100 had a known vertebral fracture. This population, as well as     any new myeloma patients, will serve as the source of the study population.   "
240706|NCT01006083|"     The objective of this study is to evaluate the safety of antiplatelet (APA)therapy     continuation in patients undergoing lumbar spine surgery (laminectomy, discectomy and     foraminotomy), and to gather evidence-based data regarding postoperative outcomes potentially     related to APA management.   "
240707|NCT01006096|"     The purpose of this study is to determine whether erlotinib is effective in the treatment of     psoriasis.   "
240708|NCT01006109|"     Background:      - Most of the time, humans make decisions according to their consequences, especially if they     will be beneficial, and will avoid or try to avoid doing an action if it has a bad outcome.     The way that the brain prepares a movement has been studied in detail, but the way the brain     makes decisions before carrying out an action is still poorly understood. Researchers are     interested in learning more about the decision-making process and how it affects the brain.      Objectives:      - To record the activity of the brain during decision-making processes.      Eligibility:      - Healthy, right-handed volunteers between 18 and 40 years of age.      Design:        -  Potential participants will have a screening visit with a medical history and          neurological examination to determine eligibility.        -  This study requires seven visits: one magnetic resonance imaging (MRI) visit and 6          magnetoencephalography (MEG) recording visits. The MEG recording visits will include          transcranial magnetic stimulation (TMS). All visits will be spaced at least 1 week          apart. Total participation will last about 6 weeks.        -  Participants will have an MRI scan at the first study visit.        -  The MEG procedures will record brain activity during a series of computer tests          involving winning or losing money. TMS will be performed during these visits, separate          from the test.   "
240709|NCT01006122|"     Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a     histaminergic agent which therefore may improve alertness and awakeness in patients with     excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS     when treated with this compound compared to placebo in patients with narcolepsy is     hypothesized.   "
240710|NCT01006135|"     The objective of this observational study is to collect and evaluate data on Health Related     Quality of Life (HRQoL) of Spiriva delivered by HandiHaler, using disease specific SGRQ in     the national samples of Central & Central European patients with varying severities of     chronic obstructive pulmonary disease (COPD) in the real life setting over the 6 months.   "
240767|NCT01006889|"     The primary aim of the study is to determine the impact on hepatic steatosis of replacing     premeal rapid-acting insulin for exenatide (Byetta) while maintaining bedtime long-acting     detemir (Levemir) insulin in well-controlled patients with type 2 diabetes mellitus (T2DM)     and nonalcoholic fatty liver disease (NAFLD).      Secondary aims are to learn: 1) the efficacy and safety of such approach and whether it is an     acceptable treatment strategy compared to intensified insulin therapy alone; 2) mechanisms of     action (effects on insulin secretion and insulin action); 3) its impact on weight (can it     prevent insulin-associated weight gain or cause weight loss) and rates of hypoglycemia; 4) if     it may improve specific plasma biomarkers of disease activity in NAFLD and inflammatory     markers common to both conditions - T2DM and NAFLD (hsCRP, ICAM, VCAM).   "
240711|NCT01006148|"     In this study we want to compare the effectiveness of a bone substitute (Allogenix Plus, a     product derived from a dead human being that has chosen to donate it prior to dying) and bone     dust from the patient's own bone pieces, versus bone dust alone in filling in the gaps that     sometimes occur after surgery for craniosynostosis . We will compare the percent of defect     filled at 1 year in 5 patients 18 months or older with metopic craniosynostosis that received     the bone substitute plus their bone dust with 5 previously operated patients with similar     characteristics that received bone dust alone to fill in the gaps. The bone substitute that     we are using will be provided at no cost by the company Biomet Microfixation. The bone     substitute Allogenix Plus undergoes extensive screening for infectious diseases as well as     processing to prevent a rejection. The product will be applied during standard surgery to 5     patients with metopic craniosynostosis of 18 months or older with skull defects no larger     than 25 cm2, so it does not require any additional surgeries. Aside from the placement of     this bone substitute the patient will proceed to receive the standard of care which includes     a pre-operative CT scan, immediate post-operative CT scan, and 1 year post-operative CT scan     of the Head. We will review these scans and look at percent of bony growth in the bone     substitute plus bone dust group . We will also see the patients in clinic, during standard of     care follow-up visits at 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months, and 1 year     post-operatively. During clinic visits we will monitor the patient closely for any potential     side effects of the bone substitute as well as complications of the surgery. We will then     review the charts of 5 patients 18 months or older that have undergone surgery for metopic     craniosynostosis until 5 patients with similar characteristics and defect size have been     obtained. We will compare their post-operative CT scans and pictures and we will look at bone     growth, bone resorption, bone gaps present, and need for secondary surgeries.   "
240712|NCT01006161|"     Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation,     there is a theoretical reason for its use in patients with severe asthma where neutrophils     are thought to play a significant role in the pathophysiology of the disease.   "
240713|NCT01006174|"     The purpose of this research study is to determine how dietary fats and oils influence the     absorption of beneficial plant pigments (carotenoids) from vegetables. The study will examine     changes in blood carotenoids in response to eating a salad with different fats/oils.   "
240714|NCT01006187|"     The purpose of this study is to compare four different analgesic strategies in adults     undergoing routine influenza immunization   "
240715|NCT01006200|"     This study is aimed to determine factors leading to obstructive granulation tissue formation     after placement of Self-Expandable Metallic Stent (SEMS) in patients with benign tracheal     diseases.   "
240716|NCT01006213|"     Overall mortality, such as that caused by cardiovascular disease, increases as weight     increases. In the Framingham Study, it was shown that obesity is a cardiovascular risk factor     independent of other risk factors such as type 2 diabetes mellitus, dyslipidemia and smoking.      Objectives:        1. To determine whether a group motivational intervention is more effective than the          standard intervention for treatment of overweight and obesity and most importantly to          maintain the attained weight loss on a permanent basis.        2. To assess whether this intervention is more effective than reducing cardiovascular risk          factors (lipid profile, apo B-100, apo A-1, fibrinogen, C-reactive protein,          hypertension, diabetes mellitus) associated with overweight and obesity, and the overall          cardiovascular risk in these patients.      Design: Randomized, multicenter, interventional clinical trial in patients with overweight     and obesity. Randomized assignment of the intervention by Basic Health Areas (BHAs). Two     groups will be established in geographically separate areas, one of which will receive the     group motivational intervention (intervention group) and the other will receive standard     follow-up (control group). BHAs located in the same building will be assigned the same group     (control or intervention) to avoid potential contamination. hypertensive treatment or with a     diagnosis of hypertension in their clinical history.      Study Scope: Primary care. The study will be conducted in 24 BHAs of Hospitalet de Llobregat     and Barcelona during 26months follow-up period. Haematic analyses will be in the carried out     at the reference laboratory.   "
240717|NCT01006226|"     The purpose of this study is to determine:        -  Whether bevacizumab increases the amount of oxygen in cancer as measured by a special          positron emission tomography (PET) scan using 64Cu-ATSM.        -  Whether the amount of oxygen in cancer as measured by 64Cu-ATSM PET scan predicts how          well the cancer responds to treatment with chemotherapy.   "
240718|NCT01006239|"     The investigators propose to establish a Biorepository of both diseased and normal tissue     collected from subjects undergoing surgery for solid tumor resection. In cooperation with the     Scripps Cancer registry, the investigators will also establish an anonymized database of     corresponding clinical information including response to treatment, disease status, and     recurrence.      The Biorepository for Scripps Health will be able to process, preserve, and distribute     samples to scientific and medical researchers at Scripps.   "
240719|NCT01006252|"     The primary purpose of this study is to see how tasisulam affects metastatic melanoma when     compared against paclitaxel as measured by overall survival.   "
240720|NCT01006265|"     This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with     relapsing-remitting multiple sclerosis.   "
240721|NCT01006278|"     This investigation describes a novel complex of structural degradation proteins that is     associated with pain in individuals with meniscal pathology undergoing arthroscopic partial     meniscectomy. The presence of the complex in the synovial fluid of the knee is sensitive and     specific for the painful state compared with similar aged controls. The absence of the     complex in asymptomatic controls makes it a useful biomarker for the disease state.   "
240722|NCT01006291|"     This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical     trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients     with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should     continue their current OAD treatment at the stable, prerandomisation dose level and dosing     frequency.   "
240723|NCT01006304|"     This exploratory study will use a thermal-grill experimental model to assess the effects of     JNJ-39439335 (50 mg, single oral dose) on the relief of pain.   "
240768|NCT01006902|"     The proposed project will document the degree of function decline, assess the relationship     between function and cancer- related symptoms and evaluate relationships between function and     quality of life. Participants are evaluated before therapy, after therapy and again 3 months     post therapy to evaluate functional change. Knowledge gained will help us plan interventions     around the time of cancer therapy to help older adults preserve or improve function.   "
240769|NCT01006915|"     The purpose of the study is to determine whether or not surgical decompression of the common     peroneal, tibial, and deep peroneal nerves in the legs of persons with diabetic peripheral     neuropathy is effective treatment.   "
241562|NCT01013194|"     The herein study consists in the transplantation of liver progenitor cells isolated from     human fetal liver tissue with the aim of improving conventional liver therapy and broadening     therapeutical options other than liver transplantation.   "
240724|NCT01006317|"     This project aims to strengthen and improve the performance of health care system in rural     China in order to improve maternal and child health. It also provides policy-makers and     health service managers with evidence for the development of informed policy on maternal and     child health (MCH). The research focuses on women of reproductive age in rural areas of China     as well as on their antenatal and obstetric care service providers, both clinicians and     policy makers. For the Member States and China, as well as other countries it will provide a     comprehensive analysis and synthesis of current state of affairs, provider and user     perspectives, of antenatal and obstetric care in rural China at national and local level.     This study seeks to assess whether improving financial accessibility to and quality of     maternal health care increase use of and impact of maternity services. This project is     implemented in 3 provinces: Anhui, Shaan'xi and Chongqing. This project will provide a     practical example and information on impact of abolishing user fees on MCH service     utilisation and develop and disseminate evidence-based policy recommendations on how to     improve access to and quality of antenatal and obstetrical care for local and central     government and international organisations, and thus serve as a step toward reaching such     important goals.      CHIMACA includes 3 types of interventions, two behavioural interventions and financial     intervention. Behavioural interventions are training for clinical skills and training health     education.   "
240725|NCT01006330|"     Dysphagia in hospitalized elders is associated with less positive outcomes in rehabilitation,     increased likelihood of readmission, increased comorbidity and mortality, and increased     length of hospital stay. In light of an increase in the elderly population in Denmark, the     consequences of dysphagia, and the importance of minimizing the risk of disability and     frailty, it is vital to emphasize safe participation of the elderly dysphagic patient in     eating, drinking and swallowing. Danish occupational therapists have an important role in the     dysphagia management, but no Danish evidence-based occupational therapy assessments for     dysphagia of elderly medical patients exist. In order to oblige this lack, the objective of     the study is to provide an assessment tool with operational definitions of dysphagia which     includes the complexity of performance in eating, drinking and swallowing, is evidence-based,     and guides occupational therapists in the treatment planning in a client-centred and     purposeful manner.      The study involves a quantitative approach, and is initiated by a translation and cultural     adaptation of the Canadian The McGill Ingestive Skills Assessment (MISA). Hereafter, the     psychometric qualities are tested. On basis of the data collected for the psychometrics, the     prevalence and characteristics of dysphagia in the study population are investigated.     Provided that the psychometric testing of the MISA reveals satisfactory levels, the effect of     using the MISA in the treatment planning is investigated.      It is hypothesized that:      The Danish translation of the MISA will demonstrates satisfactory content validity,     reliabilities, convergent validity, known-groups validity, predictive validity, criterion     validity, high levels of sensitivity/specificity and are responsive to change.      Dysphagia is prevalent in elderly medical patients at the time of admission to acute medical     care and there can be found a correlation between dysphagia severity and the presence of     comorbidity, disability, frailty, the length of hospital stay, the place of discharge and the     number of readmissions for elderly medical patients.   "
240726|NCT01006343|"     The entire study protocol will last 13 weeks. Women will be randomly assigned to one of two     experimental groups: high and low protein. All women will consume their unrestricted habitual     diet during week 1 while baseline testing and measurements are taken. Starting at week 2,     women in both groups will be counseled to consume a 750 kcal/day energy deficit diet     containing either the RDA (LP group) or more than the recommended dietary allowance (RDA) (HP     group) for protein. The energy restriction period will continue for 12 weeks (through study     week 13) and is expected to result in body weight reduction of approximately 17 pounds.     Testing and measurements will be repeated during week 13.   "
240727|NCT01006356|"     The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride     (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency     for the management of breakthrough pain after the administration of hydromorphone HCl OROS in     Korean cancer participants.   "
240728|NCT01006369|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of tumor cells by blocking blood flow to the tumor. Hydroxychloroquine may help     chemotherapy and bevacizumab work better and kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving hydroxychloroquine together with     capecitabine, oxaliplatin, and bevacizumab works in treating patients with metastatic     colorectal cancer.   "
240729|NCT01006382|"     Anaphylaxis is a severe and potentially life threatening allergic reaction which can affect     the airway, breathing and/or circulation. This reaction can be triggered by a number of     different allergens but the most common are food, medications, insect venom and latex.     Because these reactions occur suddenly and are potentially very serious, the best management     lies in the correct use of the prescribed emergency medication. Epinephrine, or adrenaline as     it is more commonly known, is the recommended drug for the treatment of anaphylaxis.     Injecting the epinephrine into the outer thigh muscle is the preferred route of     administration. For health professionals, patients and carers, this rapid administration is     facilitated by the manufacture of preloaded syringes and autoinjectors. Despite the     availability of these devices, a review of studies shows poor knowledge and skills amongst     both health professionals and patients with regards to using autoinjectable epinephrine     devices correctly. These studies found that as well as poor knowledge in using the     autoinjectors, there was a lack of confidence amongst patients and an unwillingness to carry     the device with them at all times.      In other disease groups like asthma and diabetes, psychological models which involve asking     people how they think about their illness and their related behaviours, have been found to     help in the understanding of why some people follow or adhere to health professionals advice     and why others do not. Based on these findings, this study will look at two appropriate     psychological models and their ability to predict variation in adherence to self-care     regimens in adolescents and young adults with food allergy related anaphylaxis.   "
240770|NCT01006928|"     Preterm birth is a traumatic event for parents. They cope with threatening and unfamiliar     environment of hospital, losing the parental role, and frustration. The NICU team is the main     support source for these parents. Support and providing information are most important for     parents, as they can have some control, involvement and self confidence during the     hospitalization, and also feel healthier. The hypothesis of this study is that better support     to parents lead to better subjective health feeling by them.      The study will be held among mothers to infants in NICU who are at least 7 days old. The     study will use a questionaire to assess the subjective health feeling and the estimation of     the support from the team. Sample size is about 150 mothers.   "
240730|NCT01006395|"     Less than 20% of men in whom prostate cancer is diagnosed early die from it. Cardiovascular     disease is the most common cause of death in men with early prostate cancer. A commonly used     form of treatment for prostate cancer is androgen deprivation therapy (ADT). ADT, while     effective for the treatment of prostate cancer, has been linked to undesirable side effects,     such as an increased risk of bone fractures and diabetes. Bisphosphonates, a class of drugs     that prevent bone resorption, have been show to reduce the loss of bone mineral density that     occurs as a consequence of ADT, but the effects of bisphosphonates on preservation of bone     architecture is unknown.      This project has two main goals:      To assess prospectively, in men with prostate cancer receiving ADT, the effect of:        1. the intravenous bisphosphonate zoledronic acidon ADT-induced microarchitectural decay of          bone structure.        2. ADT on insulin resistance and glucose metabolism. We will recruit 100 ambulatory men          with non-metastatic prostate cancer who are about to commence a three year course of ADT          as per routine clinical practice at Austin Health. Men will be randomised to receive          either intravenous zoledronic acid (Aclasta, Novartis Pharmaceuticals) or placebo at          baseline and after 12 months of ADT. Men with contraindications to zoledronic acid will          be excluded from the study. All 100 study subjects will have clinical and laboratory          assessment at baseline, and at 3, 6, 12, 18 and 24 months (study end), and imaging          studies at baseline and at 6, 12 and 24 months.      The study protocol is outlined in more detail below (Please see flow chart included in the in      PICF):      Clinical and laboratory assessment:      Full medical history, physical examination and quality of life assessment using the SF-36     questionnaire. Laboratory studies will include: oral glucose tolerance test (3, 12 and 24     months Commercial-in-Confidence only) and measurements of measure total testosterone, fasting     glucose, C-peptide, HBA1c, bone turnover markers.      Imaging studies:        1. Bony micro-architecture by high resolution quantitative computed tomography        2. Bone mineral density and body composition by DEXA This project will have no direct          benefit for the subjects involved in this study; however, it will improve our          understanding on the effect of zoledronic acid on bone microarchitecture in men with          prostate cancer receiving ADT. It will also help us to better understand the effect of          ADT on insulin resistance and glucose metabolism.   "
240731|NCT01006408|"     The purpose of this research study is to determine if treatment with Low Level Laser Therapy     (LLLT) is effective in treating the pain, numbness or tingling patients are experiencing     following their chemotherapy. The investigators would also like to know the number of     treatments that were needed in order to reduce their symptoms.   "
240732|NCT01006421|"     Vitiligo is a common chronic skin disease with 1-4% prevalence. It has a significant     psychosocial impact on patients and society. Different treatment modalities with variable     success rates are available.      Phototherapy is among the successful treatments but gives modest results. Some reports     documented the usefulness of Ginkgo Biloba (GB) when used alone in Vitiligo treatment.   "
240733|NCT01006434|"     Thrombolysis using Alteplase (tPA) is still the only approved specific therapy for acute     ischemic stroke (AIS). Current guidelines in western countries recommend an tPA dose of     0.9mg/kg up to a maximum dose of 90mg for patients weighing more than 100kg. However, larger     dose-finding rtPA trials for intravenous thrombolysis in AIS are missing. Based on results     from research on myocardial infarction only a few open label studies with low case rates were     initiated to evaluate the optimal dose for tPA in cerebral ischemia. These studies suggested     a narrow therapeutic range with decreased efficacy in lower dosages and an increased risk for     thrombolysis related intracerebral hemorrhage (ICH) at doses above 0.95mg/kg. The ECASS-1     trial which used a dosage of 1.1mg/kg rt-PA showed significantly higher rate of large     parenchymal hemorrhages compared to trials using 0.9mg/kg. Therefore accurate dosing is     crucial. In the acute phase two aspects complicate rtPA dosing in AIS: First, unlike in other     diseases many stroke patients are unable to communicate information on their body weight (BW)     because of their stroke symptoms (e.g. aphasia, decreased consciousness). In addition motor     symptoms prohibit easy weighing procedures in many patients. Second, the ultra-early and     narrow time window for treatment does not allow time loss to weigh each patient in the     emergency situation. Therefore routinely the attending physician has to make a visual     estimation of the patient's BW. This may be inaccurate and may cause dosing errors which has     been shown for other weight based emergency medication. There is little data on tPA-dosing     errors in stroke patients and prospective data are lacking. The aim of our study is to     evaluate availability of BW-information, accuracy of estimations and final dosing of tPA in a     routine clinical setting. Therefore the investigators evaluate different sources of body     weight estimations and also compare visual estimation with recently proposed anthropometric     measurements for body weight approximation. Finally, impact of dosing errors on safety and     efficacy are analyzed.      The initial phase will consist of 100 enrolled patients as a pilot phase for further power     calculations. Based on the results of the pilot phase enrollment will continue. The     envisioned inclusion target is up to 800 patients.   "
240734|NCT01006447|"     This randomized field trial uses a self-report daily exercise log to answer the research     question: Does frequency of instruction influence tai chi/qigong home practice exercise     persistence among residents of Senior housing?   "
240735|NCT01006460|"     This is clinical trial to document the efficacy of a proprietary standardized extract of     Arctic root in comparison to a standardized commercial extract of ginseng and placebo from an     every day consumer perspective to ameliorate mild depression, reduce stress and improve     quality of life. A newly developed adaptogenic formulation, Adapt 232, was included into the     study in order to evaluate its effect in comparison to the others.   "
240736|NCT01006473|"     The benefits of exercise training in heart failure are well established. Its effects,     however, have not been evaluated in Chagas cardiomyopathy (ChC). The investigators hypothesis     is that the exercise training may improve functional capacity, quality of life (QoL), and     reduce brain natriuretic peptide (BNP) levels in patients with ChC.   "
240737|NCT01006486|"     A clinical trial designed to compare the oral anticoagulation control obtained by an     anticoagulation clinic and the usual medical care in Chagas and Non-Chagas disease patients.   "
240738|NCT01006499|"     The investigators aim is to investigate whether adjuvant Pentoxifylline , IgM enriched IVIG     or Pentoxifylline plus IgM-enriched IVIG reduced mortality from Neonatal sepsis.   "
240739|NCT01006525|"     The purpose of the study is to determine how safe and effective it is for people with     insomnia to use zolpidem on a nightly basis for one year.   "
240740|NCT01006538|"     Wet age-related macular degeneration is the most common cause of blind registration in the     UK. Standard treatment involves regular eye injections of a drug called ranibizumab     (Lucentis). For most patients, ranibizumab maintains their vision but the effect of the drug     is temporary, and they therefore require monthly hospital visits and typically six injections     into the eye every year, probably for life.      This study tests a new surgical device that delivers a focal dose of radiation (epimacular     brachytherapy) to the macula (the part inside the back of the eye that gives fine central     vision), to try and reduce or eliminate the need for ongoing, regular eye injections. The     trial compares epimacular brachytherapy to ongoing standard treatment with ranibizumab.      Whereas most studies of this new surgical device target patients who have not yet commenced     any treatment, this study targets those who are requiring frequent eye injections, as there     are limited surgical resources and these resources are best directed to those who have not     fully responded to ranibizumab therapy, or whose response is shortlived. These patients have     the most to gain from a device that may reduce their burden of treatment. The findings in     untreated disease cannot be extrapolated to this discrete subset of patients, hence the need     for a study that targets refractory disease.      It is hypothesised that epimacular brachytherapy will reduce the frequency of Lucentis®     (ranibizumab) re-treatment that patients require, whilst maintaining visual acuity.   "
240746|NCT01006616|"     Neutrophils are thought to play an important role in the pathophysiology of chronic     obstructive pulmonary disease (COPD). Navarixin (SCH 527123, MK-7123) is an antagonist of the     cysteine-X-cysteine chemokine receptor 2 (CXCR2) and is thought to reduce neutrophil     migration to the diseased lung. It is theorized that reducing neutrophil migration to the     diseased lung will improve a participant's symptoms and the natural history of the disease.      The study will consist of a 2-week screening period followed by a 2-year (104-week)     double-blind treatment period. The 2-year Treatment Period will be made up of two phases: a     26-week (6-month) dose range-finding phase with 3 active arms and 1 placebo arm (Period 1),     followed by a 78-week (18-month) long-term safety and efficacy phase (Period 2). Participants     participating in the original 6-month study (Period 1) may elect not to continue into the     18-month extension study (Period 2).      Hypothesis: navarixin, 50 mg, or the highest remaining dose if the 50-mg dose is     discontinued, is superior to placebo with respect to improving airflow.   "
240747|NCT01006629|"     100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or     with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as     prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the     safety and efficacy of the drug in Russian subjects.   "
240748|NCT01006642|"     There has been recent interest into the potential role of mucosal barrier defects in the     pathophysiology of functional gastrointestinal disorders (FGIDs). There has been evidence of     increased intestinal permeability in patients of IBS,and abnormal tissue resistance in NERD.     Although the mucosa of Functional dyspepsia (FD) patients is endoscopically and     histologically normal, it contains ultrastructural changes, activated immune cells, along     with evidence of an increased release of mediators leading to gastric dysfunction. There is     now consistent evidence indicating that mucosal barrier defects allow the passage of an     increased load of bacteria, antigens and toxins which, in turn evoke activation of mucosal     immune responses involved in the FD symptom.   "
240749|NCT01006655|"     Respiratory diseases including Asthma are high prevalent among preschool children. Specific     treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the     amount of the drug reaching small airways and lungs is bigger how much smaller the particles     liberated by inhalers. Beclometasone is being used for treating asthma for 30 years. Lately     emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µg,     that is supposed to reach the small airways at higher concentrations and be more suitable to     patients who don't cooperate properly to the procedure of inhalation.      The investigators' group has reported successfully the possibility to perform Pulmonary     Challenge tests (adenosine, methacholine and exercise) in tender age. Other studies reported     relation between asthma control and reduction in airway hyperreactivity. The purpose of this     study is to evaluate the efficacy of Beclometasone dipropionate - Qvar to reduce airways     hyperreactivity in preschool children, as demonstrated by adenosine challenge test.   "
240750|NCT01006668|"     Endotracheal intubation is a painful and stressful procedure, which is associated with acute     increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with high     morbidity.      The aim of the study is to compare recovery time, efficacy and tolerance in a randomized     controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal     Intensive Care Unit.   "
240751|NCT01006681|"     The spread of Influenza H1N1 has prompted the development of vaccines against this virus.     Immunocompromised patients are at increased risk of developing complications of Influenza     H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population     of patients.   "
240752|NCT01006694|"     Trained para-professional health care workers will implement a stepped-care model of     depression care in commune health stations in Vietnam.   "
240753|NCT01006707|"     Opioid medications are commonly used for pain relief. When given over time, physical     dependence can occur. This results in unpleasant side effects--such as agitation and     nausea--if opioid medications are suddenly stopped. However, we do not know how withdrawal     affects the brain. We know that a medication named Ondansetron can help ease or prevent     symptoms associated with opioid withdrawal. Through imaging of the brain by fMRI, we hope to     see how opioid withdrawal, with and without the administration of ondansetron, affects brain     activity.   "
240754|NCT01006720|"     This study is designed to compare recovery times after reversal of a residual neuromuscular     block (TOF-ratio 0.2) with different doses of either neostigmine or sugammadex.   "
240755|NCT01006733|"     Blood clots contribute to the death of at least 100,000 Americans each year. Because many of     these deaths occur suddenly where treatment is impossible, the best treatment is prevention.     With this grant, researchers in Missouri, New York, Utah, Illinois, and Texas are developing     strategies to improve the safety and effectiveness of clot prevention by customizing a     popular blood thinner (warfarin) to each person's genetic and clinical profile. They     hypothesize that the use of genetics to guide warfarin therapy will reduce the risk of venous     thromboembolism (VTE) postoperatively. They further hypothesize that using a target     international normalized ratio (INR) of 1.8 is non-inferior to using a target INR of 2.5 in     VTE prevention.   "
240756|NCT01006746|"     Describe the mutual influences between trainings realized in implantation centers,     medico-technical knowledges, technical implementation, perception, fears and appreciation     felt by the patients during Home Monitoring implementation.   "
240757|NCT01006759|"     Leprosy is an infectious disease of slow evolution, manifested primarily by signs and     symptoms dermatoneurological with skin lesions and peripheral nerve, especially in the eyes,     hands and feet. The prevention of disability is essential for the control of complications.     Objective: To evaluate the physical and functional status of hands, feet and eyes, for the     appearance and evolution of sensory and motor deficiencies and classification of disability     (WHO) of a group of leprosy patients to compare and monitor the result treatment on the     progression of neuropathy and recurrence of reactions. Methodology: We performed initial     physical therapy evaluation and final, after 12 months. We conducted a clinical trial of a     series of 26 cases evaluated with newly diagnosed leprosy, treated by standard medication.     There were used methods of qualitative and quantitative. An illustrated manual of guidelines     was especially developed for this study.   "
240771|NCT01006941|"     The hypothesis of this study is that treatment with Trichuris suis ova will be safe and     effective as an oral treatment of patients with relapsing multiple sclerosis.   "
240758|NCT01006772|"     Stroke is a major cause of disabilities worldwide. Stroke survivors commonly exhibit walking     defects which lead to an altered, slow speed and asymmetric gait pattern. The main aims of     rehabilitation are to enhance recovery of movement control and regain walking ability.     Ankle-foot orthoses (AFOs), braces which encompass the foot and ankle joint extending to a     point below the knee, are commonly prescribed to address ambulation impairments in stroke     patients. Their main function is to support the foot and allow a subject to walk safely with     a gait approaching normality. This project will aim to evaluate the early provision of AFOs     as an adjunct to standard physiotherapy on the walking ability of stroke survivors. Usual     rehabilitation practice will be the control condition. Participants will be recruited from     the stroke unit of Stobhill Hospital in Glasgow. They will be randomised into two groups.     Participants allocated in the control group will receive usual clinical practice as per     routine for stroke patients. The intervention group will receive custom made solid AFOs as an     adjunct. They will be provided with three AFOs, one for use during rehabilitation and two     which will be used only during the outcome assessment sessions for research purposes. The     intervention phase will last 24 weeks. Gait analysis will be performed three times for each     participant (at baseline, 12 and 24 weeks after enrolment) in the biomechanical laboratory of     Strathclyde University. During these sessions force and movement data of patients walking     will be recorded. Fortnightly time and distance factors of gait will be measured and a     battery of functional tasks will be performed in the physiotherapy gym of the hospital using     a simple video camera and a grid lino-mat. During all assessments participants with an AFO     will be asked to walk with and without the AFO provided.   "
240759|NCT01006785|"     The purposes of this study are :        -  to investigate the safety and clinical efficacy of sole therapy with DLBS1425 in          suppressing disease-(tumour) progression in subjects with advanced/metastatic breast          cancer; and        -  to determine the minimal effective and safe dose of DLBS1425 in the therapy of          advanced/metastatic breast cancer   "
240760|NCT01006798|"     The purpose of this study is to compare the safety and immunogenicity over a 9-month period     of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of     the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in     all Household Contacts residing with the vaccinated volunteers.      Vaccinees also may participate in a substudy in which they receive a booster vaccination with     the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).   "
240761|NCT01006811|"     Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young     children. The ketogenic diet has been shown to be very effective in these children. The     modified Atkins diet is a less restrictive option than the ketogenic diet, which has been     effective in preliminary studies on refractory epilepsy in children, adolescents and adults.     Modified Atkins diet may be of special importance in infants, as proteins are not restricted,     hence no problems with growth are expected. Hence this pilot study has been planned to     evaluate the efficacy and tolerability of the modified Atkins diet in infantile spasms     refractory to conventional treatment (ACTH, vigabatrin, and anti-epileptic drugs).   "
240762|NCT01006824|"     This study compares wireless capsule endoscopy (patients swallow a pill-size camera that     sends pictures of the intestine to a recorder worn on their belt) to an x-ray study (called     dedicated small bowel contrast radiography) in patients who have bleeding from the     gastrointestinal tract without a source of the bleeding identified on routine endoscopic     examinations of the esophagus (food pipe), stomach, small intestine, and large intestine.      The investigators hope to determine if the capsule is a better test in terms of decreasing     further bleeding, decreasing the need for further diagnostic testing, and decreasing the need     for blood transfusions and time spent in the hospital.   "
240763|NCT01006837|"     The purpose of this study is to analyze changes in core body- and skin temperature during     pre-hospital and early in-hospital treatment of multi-traumatized patients. The researchers     want to investigate when trauma patients get cold and to what extent.   "
240764|NCT01006850|"     Research question: In adult emergency department (ED) patients to whom the attending ED     physician has decided to administer intravenous opioid pain control:        1. What is the incidence of serious adverse events, defined as the use of naloxone, up to a          total of 2 hours after infusion of 2 mg IV hydromorphone?        2. What is the incidence of other side effects (respiratory depression, hypotension, oxygen          desaturation, nausea, vomiting, and pruritus) at 5, 15, 30 and 120 minutes post infusion          of 2mg IV hydromorphone?        3. What is the speed of onset of 2 mg IV hydromorphone? This will be measured by asking the          patient for his NRS pain score at 1, 2, 3, 4, and 5 minutes post infusion of 2 mg IV          hydromorphone.        4. What is the incidence of administration of rescue medications?        5. For those patients who decline to enter the study, what are their reasons for refusal          (e.g. fear of becoming addicted)? The investigators believe this is yet another barrier          to providing adequate pain relief for patients with acute severe pain.   "
240765|NCT01006863|"     The prophylactic use of small doses of ephedrine may be effective in obtunding of the     hypotension responses to propofol with minimal hemodynamic and ST segment changes. The     investigators aimed to evaluate the effects of small doses of ephedrine on hemodynamic     responses of propofol anesthesia for valve surgery.      There is widespread interest in the use of propofol for the induction and maintenance of     anesthesia for fast track cardiac surgery. However, its use for induction of anesthesia is     often associated with a significant rate related transient hypotension for 5-10 minutes. This     is mainly mediated with decrease in sympathetic activity with minor contribution of its     direct vascular smooth muscle relaxation and direct negative inotropic effects.      Ephedrine has demonstrated as a vasopressor drug for the treatment of hypotension in     association with spinal and general anesthesia. Prophylactic use of high doses of ephedrine     [10-30 mg] was effective in obtunding the hypotensive response to propofol with associated     marked tachycardia. However, the use of smaller doses (0.1-0.2 mg/kg) was successfully     attenuated, but not abolished, the decrease in blood pressure with transient increase in     heart rate. This vasopressor effect is mostly mediated by β-stimulation rather than     α-stimulation and also indirectly by releasing endogenous norepinephrine from sympathetic     nerves.      Because the effect of decreasing the dose of ephedrine from 0.1 to 0.07 mg/kg may be     clinically insignificant, the investigators postulated that the prophylactic use of small     dose of ephedrine may prevent propofol-induced hypotension after induction of anesthesia for     valve surgery with minimal in hemodynamic, ST segment, and troponin I changes.      The aim of the present study was to investigate the effects of pre-induction administration     of 0.07, 0.1, 0.15 mg/kg of ephedrine on heart rate (HR), mean arterial blood pressure (MAP),     central venous and pulmonary artery occlusion pressures (CVP and PAOP, respectively), cardiac     (CI), stroke volume (SVI), systemic and pulmonary vascular resistance (SVRI and PVRI,     respectively), left and right ventricular stroke work (LVSWI and RVSWI, respectively)     indices, ST segment, and cardiac troponin I (cTnI) changes in the patients anesthetized with     propofol-fentanyl for valve surgery.   "
240766|NCT01006876|"     This study aims to explore the risk of periprocedural thromboembolic events in continuous     versus interrupted Coumadin therapy in a large, randomized high-risk patient population     undergoing radio-frequency catheter ablation for atrial fibrillation.   "
240772|NCT01006954|"     About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to     the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments     have been suggested for increasing pregnancy rate. In this study, the investigators will     compare the outcome of Microflare protocol and Flare up regimen in poor responders.   "
241596|NCT01020084|"     The purpose of this study was to investigate if salivary flow rate is important to maintain     adequate oral functions.   "
240774|NCT01006980|"     This randomized, open-label study evaluated the efficacy, safety and tolerability of     vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with     metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally     twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was     continued until disease progression or unacceptable toxicity occurred. The data and safety     monitoring board recommended that patients in the dacarbazine group be allowed to cross over     to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both     overall survival and progression-free survival endpoints had met the prespecified criteria     for statistical significance in favor of vemurafenib.   "
240775|NCT01006993|"     To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic     stroke patients following administration of intravenous tPA.   "
240776|NCT01007006|"     The objective of this study is to evaluate whether use of TRMDU in addition to medication     review leads to improved outcomes and reduced health care costs for patients when compared     with medication review alone. The study will be conducted in patients assigned to Department     of Defense (DOD) Warrior Transition Units (WTU's), similar DOD units, and VA polytrauma     centers.   "
240777|NCT01007019|"     First in human study   "
240778|NCT01007032|"     In this study, patients will initially receive intravenous (I.V.) IMC-A12 every 2 weeks or     every 3 weeks for 6 weeks (one cycle). After the first cycle, patients experiencing a best     overall response of complete response, partial response, or stable disease will continue to     receive IMC-A12 at their cohort dose and schedule until there is evidence of progressive     disease (PD), or until other withdrawal criteria are met. Patients will be enrolled at one     study center, located in the National Cancer Center Hospital - East, Kashiwa, Japan.     Approximately 20-30 patients are anticipated.   "
240779|NCT01007045|"     Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care     for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as     Well's criteria, D-dimer blood testing, and Radiology department ultrasound.      The purpose of this study is to determine whether Emergency Physicians can safely rule out     deep vein thrombosis using Well's criteria and D-dimer blood testing combined with Emergency     department bedside ultrasound.   "
240780|NCT01007058|"     The goal of this laboratory research study is to see if researchers can predict whose cancer     will stay in remission and whose will return in patients receiving treatment for bladder     cancer.   "
240781|NCT01007071|"     Patients with Growth hormone (GH) deficiency often report impaired quality of life and     difficulty with mental functioning. It has been suggested that GH replacement in such     patients leads to improvement in cognitive function. The aim of this study is to elucidate     the effects of GH replacement in patients with GH deficiency on cognitive function using     structural and functional neuroimaging and cognitive testing.   "
240782|NCT01007084|"     The purpose of this study is to determine whether propranolol can decrease pain symptoms in a     common subset of patients admitted to a trauma center after injury.   "
240783|NCT01007097|"     The purpose of this study is to determine the safety and efficacy of multiple doses of     TAK-875, once daily (QD), in subjects with Type 2 Diabetes Mellitus.   "
240784|NCT01007110|"     DHA, a type of fatty acid, is important in early development, both in terms of reproductive     physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA     has been shown to lower triglycerides and is important to cardiovascular health and autonomic     control, lowering heart rate and blood pressure and increasing heart variability. Little is     known about how fatty acids impact cardiac control in infants, children or the fetus. Our     hypothesis is that maternal DHA supplementation (600 mg/day) will lower fetal HR and increase     fetal HRV.   "
240785|NCT01007123|"     The purpose of this trial is to determine the efficacy and safety of A3309 administered to     patients with chronic idiopathic constipation.   "
240786|NCT01007136|"     The purpose is to determine whether application of a non-invasive battery powered device     called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness     after stroke beyond what is achievable with rehabilitative treatment alone.   "
240787|NCT01007149|"     This study will assess the change in the expression of FcεRI receptors of blood basophils and     dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in     adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal     therapy.   "
240788|NCT01007162|"     To explore issues patient experience and satisfaction with a sample of patients recently     discharged from critical care.   "
240789|NCT01007175|"     This primary purpose of this study is to evaluate the safety, tolerability, and     pharmacokinetic properties of multiple ascending doses of ATN-103 administered subcutaneously     (below the skin) to Japanese subjects with active rheumatoid arthritis and on a stable     background of methotrexate. Some subjects will receive ATN-103 while other subjects will     receive a placebo.   "
240790|NCT01007188|"     The U.S. Department of Agriculture (USDA) wants to learn more about the number of calories in     almonds and the mechanisms of the health effects of almonds. Epidemiologic studies have     demonstrated an inverse or no relationship between nut consumption and body weight, despite     the fact that nuts are an energy dense food. Intervention studies have shown that consumption     of nuts has no effect on body weight or an effect that is significantly less than predicted.     Fecal analyses in studies with peanuts, almonds, and pecans have found increased fecal fat     and energy loss with nut consumption; however studies with almonds are lacking.   "
240821|NCT01000649|"     The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE     202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood     vessel) leakage. FE 202158 had previously been tested in healthy volunteers.   "
240791|NCT01000246|"     Patients treated with chemotherapy or immunosuppressives are at higher risk of influenza     infection and mortality and morbidity are higher compared to healthy adults. Vaccination     against the influenza virus can prevent these complications. In this study it is investigated     whether vaccination during chemotherapy is effective in reaching protective serum antibody     concentrations and the relation between time of vaccination (day 4 +/- 1 day versus day 16     +/- 1 day of the chemotherapy cycle).   "
240794|NCT01000285|"     The rationale of the current study is to explore the use of combination chemotherapy together     with antiretroviral agents in order to determine the efficacy and toxicity of this approach,     while also examining markers of virus replication and expression, and tumor cell     proliferation to gain understanding of the biological basis of this malignancy and to     identify predictors of response.   "
240795|NCT01000298|"     The need for oral antibiotics as part of the case management of severe acute malnutrition     (SAM) in the outpatient setting has not been studied in a prospective trial. This study will     compare the recovery rates of children with SAM treated at home with locally-produced     ready-to-use therapeutic food (RUTF) with and without prescribed antibiotics as part of their     outpatient case management. The investigators hypothesize that there will be no significant     difference in rates of recovery between children who receive and children who do not receive     antibiotics.   "
240796|NCT01000311|"     This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and     non-interference of concomitant routine vaccines by MenACWY in an infant age group.   "
240797|NCT01000324|"     This study will evaluate the persistence of the immune response to HAV (Hepatitis A Virus)     antigens and HBs (Hepatitis B surface) antigens in healthy adults previously vaccinated with     GlaxoSmithKline (GSK) Biologicals' Twinrix™ Adult. The subjects will be invited for blood     sampling 16, 17, 18, 19 and 20 years after vaccination to evaluate the antibody persistence.     For subjects in whom low circulating antibodies are detected, the presence of immune memory     against hepatitis A & B antigens will be investigated by the administration of a challenge     dose of the appropriate vaccine (Havrix™ and/or Engerix™-B) at the next planned visit.      No new subjects will be recruited during this study.   "
240798|NCT01000337|"     Anesthesia may affect the function of vital organs. Liver is one of them. The investigator's     hypothesis is that intravenous or inhalation anesthesia does not impair liver function as     assessed by more elegant tests like markers indicating liver apoptosis. In the present     randomized prospective trial female patients scheduled for mastectomy or thyroidectomy will     receive inhalation or total intravenous anesthesia and markers for liver dysfunction will be     determined.   "
240799|NCT01000350|"     The investigators will test whether an intravenous infusion of saline (salt water) will     improve the exercise capacity in patients with postural tachycardia syndrome (POTS).   "
240800|NCT01000363|"     This pilot study aims to increase access to diabetes education by delivering it in a     culturally-appropriate community setting and by involving different members of the diabetes     care team including physicians, diabetes educators, and health promoters/community health     workers.      Diabetes medical group visits will be held at the Grady North DeKalb satellite clinic the     third Thursday of the month starting in October 2009. There will be two cohorts of patients-     English speaking patients and Spanish speaking patients. Each group will be scheduled for 4     2-hour group visits throughout a period of 9 months. These visits will be every 8 weeks for     each group. During the visit, the patient will be seen by a physician, attend a diabetes     education session, re-fill their diabetes medications and receive lab orders.   "
240801|NCT01000376|"     The purpose of this study is to investigate whether ketoconazole, taken orally, influences     the level of eribulin in the blood when the two drugs are given at the same time. The study     will enroll patients with solid tumors whose cancer became worse even after standard     treatment, or for whom there is no standard treatment available. The study will also     investigate whether eribulin given together with ketoconazole is safe (has few side-effects)     and is effective against cancer.   "
240802|NCT01000389|"     To investigate the effect of the treatment with Grindcare® on the parafunction of the     muscles- and jaw activity (Bruxism) during sleep.   "
240803|NCT01000402|"     This is an outpatient program for children and adolescents with bipolar disorders. The     naturalistic approach of the program will allow a proper investigation of the disorder,     assessment of environmental and biological factors, the conduction of treatment studies, and     follow-up of the subjects.   "
240804|NCT01000415|"     The purpose of this study is:        -  to compare the effectiveness between the new strategy of treatment (given cis-platinum          plus gemcitabine-neoadjuvant chemotherapy followed by surgery),and standard treatment          (given cis-platinum/carboplatin during radiation-concurrent chemoradiation)in specific          group of cervical cancer patients (stage Ib2-early IIb)        -  to evaluate quality of life in both group of patients(standard treatment vs.experimental          group)   "
240805|NCT01000428|"     Erlotinib is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.     Higher response rates were observed in a subset of patients with female gender, Asian     ethnicity, no smoking history, mutations in EGFR tyrosine kinase, high EGFR gene copy number     and adenocarcinoma histology. However, the therapeutic effect of Erlotinib is not confined to     patients whose tumors harbor EGFR mutations and other predictors of efficacy of this agent.     And these tests require time and sufficiently large specimens for processing, whereas many     patients with advanced NSCLC are diagnosed based on cytology alone.      This study was designed to evaluate FLT-PET or FDG-PET usefulness in the early assessment of     treatment response and in predicting patient outcome after erlotinib monotherapy for patients     with non-small cell lung cancer prospectively. Changes in tumor FLT or FDG uptake 7 days     after the initiation of treatment will be compared between responders and nonresponders based     on subsequent CT scans.   "
240806|NCT01000441|"     Approximately 30% of patients with rheumatoid arthritis have an inadequate response to     anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second     anti-TNF or change of biologic, with a different mechanism of action, such as abatacept,     rituximab and tocilizumab. No controlled trial compared these two strategies face to face.     The present objective is to investigate the issue whether one of these strategies could have     a better efficacy in a pragmatic trial in the setting of current practice.   "
240807|NCT01000467|"     To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in     healthy male subjects.   "
240808|NCT01000480|"     This trial investigates pemetrexed and cisplatin followed by pemetrexed and cisplatin in     combination with radiotherapy in participants with locally advanced, non-small cell lung     cancer (NSCLC). The purpose of the study is to assess the antitumor activity as measured by     progression free survival 1 year after start of treatment with study drug.   "
240810|NCT01000506|"     The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously     (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma     despite receiving high doses of standard asthma medications. The study will look at different     doses of mepolizumab in comparison to a placebo.   "
240811|NCT01000519|"     Randomized study on the comparison between aerobic training versus progressive resistance     training over a 2 months period for older adults with type 2 diabetes. The hypothesis is that     progressive resistance training is just as effective as aerobic training on Hba1c and could     be an alternative training for those older diabetic patients who cannot participate in     aerobic exercise.   "
240812|NCT01000532|"     This investigation is designed to demonstrate the clinical efficacy and safety of the     low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical     investigation.   "
240813|NCT01000545|"     The purpose of this study is to determine the effect and safety of Sulodexide in Filipino     patients with Chronic Kidney Disease (CKD).   "
240814|NCT01000558|"     RATIONALE: Collecting and storing samples of blood from patients with cancer to test in the     laboratory may help the study of cancer in the future.      PURPOSE: This research study is collecting and storing blood samples from patients with     previously untreated non-Hodgkin lymphoma.   "
240815|NCT01000571|"     This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin     monovalent influenza vaccine in immunocompromised children and young adults.   "
240816|NCT01000584|"     The purpose of this study is to assess the safety and effectiveness (immune response) to a     licensed H1N12009 influenza vaccine in adults when given at the same time or prior to the     seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants     will be randomized into 2 groups. One group will receive one dose of a licensed H1N1 vaccine     and one dose of the seasonal influenza vaccine at the same time; the second group will     receive the seasonal influenza vaccine 3 weeks after receiving the licensed H1N12009     influenza vaccine. Study procedures include: medical history, blood samples and completing a     memory aid. Participants will be involved in study related procedures for approximately 3-6     weeks depending upon the group assignment.   "
240817|NCT01000597|"     Previous studies have shown potentially higher exposure to fluticasone furoate in Japanese     subjects compared with Caucasian subjects. The reasons for these potential differences are     unclear. Therefore this study is being done to look at and compare how fluticasone furoate is     processed by the body in healthy Caucasian, Japanese, Korean and Chinese subjects after     inhaled and intravenous administration. The data obtained will be used to help in the     clinical development of the drug in Japanese and other East Asian populations.   "
240818|NCT01000610|"     In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in     patients with active rheumatoid arthritis who have had an inadequate response to     methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and     background methotrexate (10-25mg po or sc weekly). After the initial study period of 24     weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated     time on study treatment is 1-2 years and target sample size is <50   "
240819|NCT01000623|"     Rationale: Venlafaxine may help relieve hot flashes in women who have had breast cancer.     Hypnosis or focused attention may help control hot flashes in postmenopausal women. It is not     yet known whether giving venlafaxine together with hypnosis or focused attention is more     effective in treating hot flashes.      Purpose: This randomized clinical trial is studying venlafaxine together with hypnosis or     focused attention in treating patients with hot flashes.   "
240820|NCT01000636|"     The aim of this study is to determine possible molecular changes on large scale gene     expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic     keratoses (AK) and cancerised field in renal transplant recipients.   "
240824|NCT01000688|"     Rationale: Cardiovascular complications in type 2 diabetes are the leading cause of morbidity     and mortality associated with the disease. Endothelial dysfunction is regarded as an     important factor in these vascular complications.      The introduction of glucagon-like peptide-1 (GLP-1) analogues and dipeptidyl peptidase IV     (DPP-IV) inhibitors for the treatment of type 2 diabetes is of special interest because of     possible influences on endothelial function. Numerous reports have shown that GLP-1 improves     endothelial function.      Objective: To determine whether a four week treatment with vildagliptin compared to acarbose     improves endothelial dysfunction in patients with type 2 diabetes mellitus.   "
240825|NCT01000701|"     Subproject 1: Optimize prevention after acute coronary syndromes (ACS) by improving caregiver     and patient education (http://elips.hug-ge.ch/eng/index_eng2.htm)      Subproject 2: Discover novel genomic biomarkers of ACS in leukocyte subsets by means of     analyzing gene expression profiles and function      Subproject 3: Evaluate novel diagnostic and prognostic biomarkers in soluble form in     blood/plasma and urine      Subproject 5: Visualize the vulnerable plaque using intravascular ultrasound/optical     coherence tomography (IVUS/OCT) and correlate with outcome and biomarkers      Subproject 7: Characterize the effects of inflammation on progenitor/stem cell-mediated     repair after ACS by means of analyzing gene expression profiles and function   "
240826|NCT01000714|"     Psoriasis is a chronic disorder characterized by erythematous scaly patches which affect the     scalp, trunk, extensor surfaces of the limbs and the genital area. The common form of     psoriasis is referred to as psoriasis vulgaris. There are several variants of psoriasis such     as guttate psoriasis, inverse psoriasis, pustular psoriasis and erythrodermic psoriasis.      Psoriasis is highly prevalent in the general population, mainly as a result of its chronicity     and the absence of a cure. The estimates of psoriasis prevalence are within the range of 0.5%     to 4%.      The diagnosis of psoriasis is made on a clinical base, usually by physical examination,     performed by a dermatologist. Although skin biopsy may be useful in some cases, there is no     laboratory test which may serve as a reference standard to the clinical diagnosis of     psoriasis.      Psoriasis in its mild cases per se is not associated with excess mortality, however, the     disease may affect quality of life of affected patients to a substantial degree. Psoriasis     may be readily apparent to others because of scales and redness of the skin. The skin may     itch and scales may shed from the patients to the environment or directly on other people.     Feelings of stigmatization and major changes in life-style caused by psoriasis have been     documented in numerous studies. The burden of the disease may be exaggerated due to expensive     therapy and complicated therapeutic regimes Patients with mild to moderate psoriasis are     usually treated with topical treatments. Photo-therapy or systemic treatments are reserved to     patients with moderate to severe disease.      Topical corticosteroids may lead to rapid improvement in psoriasis, however rapid relapse     following discontinuation is the common practice leading to chronic use.      Calcipotriene ointment may also be used and requires 8 to 12 weeks of use for maximal effect     and often causes local irritation, particularly when used on the face. The use is limited to     100 gr/week due to hypercalcemia that might follow systemic absorption.      Vitamin A derivative tazarotene may be also be used for plaque psoriasis. Although it can     produce longer remissions than topical steroids, local irritation, cost, and teratogenicity     limit its use.      Coal tar products may be used as steroid-sparing agents, especially useful for enhancing the     efficacy of natural sunlight and phototherapy. Application can be cumbersome because of     irritation, unpleasant smell, brown color that can stain clothing, and propensity to cause     folliculitis.      All of the above treatments are particularly problematic for the face and genital psoriasis     due to the potential side effects and mainly possible severe irritation reducing patients     compliance.      Psirelax is a novel topical medication directed for the treatment of patients with psoriasis.     The formulation of Psirelax includes the following substances: 5%-15% quince seeds jelly,     10%-40% natural base cream (e.g. Ferntree Cottage Pure Base Cream), 55%-75% mixture of     natural anti-oxidants (e.g. Vitamin E, wheat germ oil, Safflower oil), natural skin softening     agents (e.g. sweet almond oil, sesame oil), natural absorption aids (e.g. jojoba oil,     vegetable squalene), natural tissue regenerating and protecting agents (e.g. grape seed oil,     sunflower oil), natural preservatives (e.g. paraben, tea trea essential oil, thyme essential     oil, grapefruit seed extract, Vitamin E) and natural thickening agents (e.g. bee wax,     aloevera, medicinal Vaseline, coconut oil, guar gum, palm oil, borax)      In a preliminary observation, a patient with severe psoriasis applied Psirelax three times     each day during four days. The patient reported complete disappearance of the psoriatic     plaques and pruritus was reduced by 70%. It was suggested to conduct an open study to assess     the effect of Psirelax in patients with psoriasis vulgaris.      The aim of this study is to examine the safety and efficacy of Psirelax in the treatment of     psoriasis.   "
240827|NCT01000727|"     This study will test whether darapladib can safely lower the chances of having a     cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g.     medical procedures performed to restore the normal blood flow in patients with     atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome     (also called ACS).   "
240828|NCT01000740|"     The primary objective is to describe the quality of life of long-term survivors who are not     terminated from the EAP.   "
240829|NCT01000753|"     RATIONALE: Collecting and storing samples of tissue from patients with cancer to test in the     laboratory may help the study of cancer in the future.      PURPOSE: This research study is collecting and storing tissue samples from patients with rare     or cutaneous non-Hodgkin lymphoma.   "
240830|NCT01000766|"     The purpose of this study is to try to develop new blood tests that may help doctors identify     if a drug is hurting a person's liver.   "
240841|NCT01000909|"     Part I:      Proof of concept trial to achieve normal venous pressure values under different provocation     maneuvers in healthy persons      Part II:      Non invasive measurement of venous pressure under different provocation maneuvers in patients     with chronic venous disease   "
240831|NCT01000779|"     Background: Variceal bleeding is a major cause of morbidity and mortality in patients with     Non Cirrhotic Portal Hypertension (NCPH). Beta blockers (BB) and endoscopic variceal ligation     (EVL) have been used to prevent rebleeding in these patients, largely based on data from     cirrhotic patients. Endotherapy in the form of EST has been well studied in preventing     rebleed in patients with NCPH. Initial studies showed that EST significantly reduced the     rebleeding rate in patients of NCPH. Data from these studies suggests a rebleed rate of     approximately 25% at 2yr and 35% at 5 years.      Beta blockers have been found to be quite effective in both primary as well as secondary     prophylaxis of variceal bleeding in cirrhotic and are accepted mode of treatment. In contrast     to liver cirrhosis, published data on the effect of beta blocker therapy on NCPH are scanty.     Animal data and human data suggests that beta blockers reduce portal pressure in patients     with NCPH. In two placebo controlled trials of propranolol on secondary prophylaxis of     variceal bleeding in non cirrhotic patients. both studies demonstrated the efficacy of     propranolol in decreasing rebleed rate. However, no comparisons hae been made with EVL till     date.      Hypothesis: The investigators hypothesis that In patients with NCPH, treatment with beta     blockers will lead to reduction in portal pressure and decrease in portosystemic shunting     leading to reduction in variceal rebleeding Aim of the study: Aim: To compare the efficacy     and safety of Propranolol and EVL in the prevention of variceal rebleeding in patients with     NCPH.   "
240832|NCT01000792|"     The prevalence of allergic rhinitis is high and appears to be rising worldwide. Therefore, it     is important and necessary to understand and visualize therapy effects on this disease. In     this study we will demonstrate the effect of levocetirizine on nasal cavity dimensions by     assessing not only standard nasal flow diagnostics such as rhinomanometry and acoustic     rhinometry, but supplement exami¬nation procedures with long-term rhinometry and magnetic     resonance imaging (MRI). With the aid of a virtual model and computer fluid dynamics, we are     able to simulate nasal air flow and provide three-dimensional visualization of the computed     flow.      In previous trials ([Bachert], [deBlic], [Day] and [Deruaz]) it has been shown that allergic     symptoms, especially nasal congestion, diminish significantly under treatment with     levocetirizine. We will demonstrate this anti-obstructive effect by comparing the reaction to     nasal allergen challenge before and after four-week treatment with levocetirizine.   "
240833|NCT01000805|"     The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for     8 weeks to patients diagnosed with major depressive disorder, who also report associated     painful physical symptoms, is better than placebo when treating depression and its associated     painful symptoms.   "
240834|NCT01000818|"     An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on     MK0518 as part of a stable treatment regimen for HIV.   "
240835|NCT01000831|"     The purpose of this study is to compare the safety and effectiveness (immune response) to one     or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an     additive that can boost the immune response. The study will enroll 300 children (ages 6-35     months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 3 weeks apart.     Study procedures include: medical history, blood samples and completing a memory aid.     Participants will be involved in study related procedures for approximately 6 weeks.   "
240852|NCT01001052|"     The purpose of this study is to evaluate and compare the relative bioavailability of a single     dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young , healthy subjects     18-30 years of age compared to a group of older, generally healthy subjects 60 years of age     or older following an overnight fast.   "
240853|NCT01001065|"     Cross sectional observational ultrasound study of transplanted kidneys and the carotid artery     in consecutive recruited outpatients.   "
240905|NCT01001754|"     Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral     infections. The purpose of this study is to evaluate the safety and antiviral effects of     several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in     combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis     C infection who have received no prior treatment for this disease.   "
240836|NCT01000844|"     The original Joint Outcome Study (JOS) enrolled 65 boys with hemophilia from 16 sites     nationally. The subjects were randomized to one of two arms (prophylaxis or an enhanced     episode-based treatment)and were followed prospectively until the age of six. At the age of     six, the proportion of children on each treatment arm who developed bone or cartilage damage     as determined by X-Ray or MRI was assessed. In addition, the function and structure of the     index joints (defined as knees, ankles, and elbows)were evaluated using a physical assessment     scale specially designed for preschool children.      The specific aim of the Joint Outcome Study Continuation (JOSC) is to extend observations of     the children participating in the original JOS until the subjects reach the age of 18 years     in order to determine the natural history of joint development in hemophilia and the impact     of primary or secondary prophylaxis on the prevention, limitation, or reversal of hemophilic     arthropathy. In addition, plasma and DNA will be collected and banked yearly for current and     future studies of biomarkers and predictors of hemophilia outcomes.   "
240837|NCT01000857|"     The primary purpose of this study is to compare the steady-state pharmacokinetic profile of     paroxetine CR (controlled-release) at the dosage of 25mg/day using the proposed final market     tablet of CR 25mg in Japan with that of standard paroxetine IR(immediate-release ) at the     dosage of 20mg/day using the currently marketed tablet of IR 20mg in Japan.   "
240838|NCT01000870|"     The purpose of the study is to evaluate the efficacy and safety of MNI-513 positron emission     tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with     Alzheimer's disease compared to healthy volunteers.   "
240839|NCT01000883|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients will respond to     treatment.      PURPOSE: This research study is looking at tissue and blood samples from women with locally     advanced or metastatic breast cancer   "
240840|NCT01000896|"     The primary purpose of this study is to explore the safety and tolerability of AZD0530 in     combination with carboplatin and paclitaxel in Japanese patients with non small cell lung     cancer and epithelial ovarian cancer.   "
240843|NCT01000935|"     Partial-thickness and full-thickness rotator cuff tears are common soft-tissue conditions     that often require surgical treatment. Initial efforts to improve tendon healing centered on     improving the strength of the repair construct. More recent studies have focused on biologic     enhancement of the healing process. The use of platelet concentrates to improve healing, has     been explored considerably during the last decade. Platelet Rich Plasma (PRP) is a fraction     of plasma that has been isolated and used to enhance regeneration in bone and soft tissues.      There is information on use of PRP in oral surgery, achilles tendon healing, limb lengthening     procedures, chronic elbow tendinosis, ruptures/degenerative changes in the patellar tendon,     and osteoarthritis of the knee. There are no randomized clinical trials to our knowledge that     have examined the impact of PRP in patients with rotator cuff tear.      The objective of the proposed pilot study is to examine the effectiveness of autologous     Platelet Rich Plasma (PRP) application in promoting healing of the rotator cuff (RC) tendons     following arthroscopic rotator cuff repair through a randomized controlled study.   "
240844|NCT01000948|"     This is a prospective, open, one-arm, two-centre, Phase II clinical safety pilot-study. The     trial is designed to gain initial safety and efficacy-related data on once-daily orally     administered ZD4054 10 mg in prior chemotherapy treated patients with metastatic     hormone-resistant prostate cancer.   "
240845|NCT01000961|"     Cystinosis is an inherited disease that if untreated, results in kidney failure as early as     the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate)     which must be taken every six hours for the rest of the patient's life to prevent     complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being     studied to see if it may be able to be given less frequently, once every 12 hours, and have     similar results to four times a day Cystagon®.   "
240846|NCT01000974|"     The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the     vaccine, to address the relevant concomitant vaccine administrations and to provide a     comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib     vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and     15-18 months of age. This study is designed with a primary and a booster phase.   "
240847|NCT01000987|"     The purpose of this study is the examine the effect of varenicline on reactivity to a high     dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of     the blood alcohol curve.   "
240848|NCT01001000|"     Prospective observational ultrasound study of native arterio-venous fistula for haemodialysis     with venous pressure measurement using controlled compression ultrasound.   "
240849|NCT01001013|"     The objective of the study is to investigate the drug interaction between LC15-0444 and     pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and     pioglitazone are administered concomitantly and each alone in healthy male subjects.   "
240850|NCT01001026|"     The purpose of this study is to assess the safety and effectiveness (immune response) to a     licensed H1N12009 influenza vaccine in aboriginal children and adults. The study will enroll     200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will     receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed     H1N1 vaccine approximately 3 weeks apart. Study procedures include: medical history, blood     samples and completing a memory aid. Participants will be involved in study related     procedures for approximately 3 weeks (adults) or 6 weeks (children).   "
240851|NCT01001039|"     This study proposes to develop and validate a new instrument designed to measure facial and     nasal discomfort related to chronic sinusitis. The second phase of the study will be to use     this instrument to measure correlation with sinus computed tomography (CT) scans.   "
240854|NCT01001078|"     This study will compare two supraglottic airway devices currently on the market. Supraglottic     airway devices are used during general anesthesia to provide a patent airway. They are     inserted blindly into the mouth once the patient has lost consciousness and they cover the     laryngeal inlet. The I-Gel and the Supreme laryngeal mask airway (LMA) are the two devices to     be compared. The I-Gel has no inflatable cuff, which makes it different from all other     supraglottic airway devices currently in use. The Supreme shares some characteristics of the     other LMA devices, but it is disposable. Our main goal will be to compare the airway leak     pressure and the peak airway pressure of each devices. We will also measure the time needed     for insertion, number of attempts needed to secure the airway and side effects related to the     airway (cough, dysphagia, trauma, hoarseness of voice, sore throat).   "
240855|NCT01001091|"     The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment     of the signs of inflammation associated with allergic conjunctivitis.   "
240856|NCT01001104|"     The main purpose of this study is to assess dose-response characteristics in Japanese     patients with Type 2 Diabetes taking LY2189265 monotherapy.   "
240857|NCT01001117|"     The use of a femtosecond laser in cataract surgery that gives equivalent or improved results     comapred to conventional phaco-emulsification surgery.   "
240858|NCT01001130|"     Non-interventional, open-label, single group, multicentric post-marketing surveillance to     monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients     according to the prescribing information.      AVAMYS is a registered trademark of the GSK group of companies.   "
240859|NCT01001143|"     The main objective is to determine the safety and tolerability of combination decitabine and     bexarotene during four cycles of therapy.   "
240870|NCT01001286|"     This randomized controlled trial (RCT) evaluates the effectiveness of Questscope Non-Formal     Education (QS NFE) on impacting psychosocial outcomes for out-of-school youth, ages 13-21, in     Jordan. QS NFE is an empowerment-based education program. A unique agreement with the     Jordanian Ministry of Education enables participating youth to receive a 10th-grade     equivalent certificate upon successful completion of the 24-month non-formal education. The     main components of QS NFE include retraining formal education teachers for fostering positive     relationships with at-risk youth, asset-building learning and social activities, and a     youth-driven learning environment.      The study hypothesis is that by engaging youth in positive relationships with local teachers     and enabling the youth to drive the learning experience, the intervention will have positive     impacts on general self-efficacy, social supports, social skills, and strengths and     difficulties.   "
240860|NCT01001156|"     The purpose of this study was to use associated breathing exercises the incentive inspiratory     of load lineal pressoric, Threshold® IMT, or of load pressoric alinear, Voldyne®, in     institutionalized elderly, comparing the effect of the same ones in the training of the     breathing musculature, for the increment of the muscular strength, expressed by the maximum     breathing pressures (MIP and MEP).      From the total number of admitted people (n = 52), 12 individuals were excluded: one by     appearance of cognitive deficit, one by death (stroke), one by visual deficit (glaucoma) and     twelve by failure to continue the training. After selecting the sample, the 37 participants     were randomly divided into three different groups: the Threshold Group (TG; n = 13, age = 70.     93 ± 8.41 years old, BMI = 24.06 ± 3.69 kg/m²), the Voldyne Group (VG; n = 12, age = 70.54 ±     7. 73 years-old, BMI = 27.17 ± 5.66 kg/m²) and the Control Group (CG; n= 12, age = 73. 92 ±     7.28 years-old, BMI = 24.80 ± 5.42 kg/m²). The TG and VG received treatment with respiratory     exercises and Threshold and Voldyne muscular training, respectively. The CG received only     respiratory exercises.   "
240861|NCT01001169|"     The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'     investigational influenza vaccine GSK2340274A following one dose and following a second dose,     using the same dosage as has been used in the H5N1 development program in Japanese children     aged 10-17 years and an alternative dose in children aged 6 months to 9 years.   "
240862|NCT01001182|"     Rheumatoid Arthritis (RA) is a chronic debilitating disease, causing severe pain and     progressive joint destruction and leading to partial loss of mobility. The disease has a     severe impact on patients' quality of life, due to the pain and physical impairment it     causes, which can also result in psychological and social difficulties. Moreover, the chronic     nature of the disease deems necessary the long-term use of medication, causing significant     costs to the patient and the healthcare system. The decline in functional ability can cause     problems at work, with reduced productivity or even unemployment. In addition, RA can limit     the patients' ability for self-care, hence imposing a further burden on the patients'     families and the society.      Many international studies have confirmed the reduced quality of life for people suffering     from RA [1-3], as well as the large economic impact of the disease on the patients, the     health system and society [4-6]. However, no assessment of the above impact of RA on the     Greek population has been published so far.      A wide research of the literature confirms the relationship between costs and quality of life     on the one hand and functional ability (as measured by the Health Assessment Questionnaire)     on the other hand. [7-8] The impact of functional ability on quality of life is     straightforward, however studies also demonstrate that as disease symptoms progress, without     proper treatment, the overall costs undertaken by the patient or the healthcare system can     rise significantly. On the other hand, if effective treatment can lessen or postpone the most     serious consequences of the disease (such as extensive joint damage that could lead to     surgical replacement), the savings on healthcare can offset some of the costs of the more     effective drug therapies.      In the light of the above findings, it seems important that in order to properly assess     therapeutic strategies for RA patients it is necessary to have an accurate view of the total     burden of RA on the population. It is also important to be able to establish a robust     relationship between functional ability and impact of RA on costs and quality of life.   "
240863|NCT01001195|"     This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study     will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).   "
240864|NCT01001208|"     The purpose of this study is to evaluate the efficacy of adding methotrexate to etanercept     compared with etanercept monotherapy as measured by the percentage of participants achieving     a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week     24.   "
240865|NCT01001221|"     Primary Objectives:        -  Study part 1: To determine the Maximum Tolerated Dose (MTD) and the Dose Limiting          Toxicities (DLTs) of cabazitaxel administered as a 1-hour infusion in combination with          gemcitabine, every 3 weeks in patients with advanced solid malignancies.        -  Study part 2: To determine the antitumor activity of cabazitaxel in combination with          gemcitabine, in an additional extended cohort of 15 patients with advanced solid          malignancies treated with the defined MTD, as assessed by objective response rate (ORR)          according to the revised guideline for Response Evaluation Criteria in Solid Tumours          (RECIST 1.1 criteria).      Secondary Objectives:        -  To assess the safety profile of the combination regimen of cabazitaxel with gemcitabine.        -  To assess the pharmacokinetics (PK) of cabazitaxel, gemcitabine and its metabolite 2',2'          difluorodeoxyuridine (dFdU) when given in combination.        -  To determine Time to Progression (TTP), Objective Response Rate (ORR), and Duration of          Response (DR), in the extended cohort of patients treated at the MTD in Part 2 of the          study and the patients who received the MTD in Part 1 component.      For study part 1, dose levels were to be escalated according to predefined dose escalation     decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at     least 2 patients developed a DLT during the first 3 weeks of treatment. There was no further     dose escalation when this dose was achieved. The MTD was defined as the highest dose at which     0 or 1 of 3 to 6 patients, respectively, experienced DLT during the first 3 weeks of     treatment.   "
240866|NCT01001234|"     This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment     of Migraine in Children and Adolescents.   "
240867|NCT01001247|"     The purpose of this study is to investigate the extent by which intake of 20 mg once daily     (q.d.) omeprazole influences the levels of TMC278 in the blood after intake of 25 mg q.d..     This study also investigates - in case levels of TMC278 are reduced when co-administered with     omeprazole - whether a double dose of TMC278 (50 mg q.d.) or a separation of intake of both     drugs by 12 hours may circumvent a decrease of TMC278 levels in the blood below the clinical     effective concentration. Omeprazole is prescribed to reduce the production of gastric acid.     Since TMC278 requires gastric acid to be properly dissolved and taken up in the blood     circulation, intake of omeprazole has an influence on the levels of TMC278 in the blood     circulation. This effect has been revealed in a previously conducted clinical trial, using     the combination of 150 mg TMC278 q.d. and 20 mg q.d. omeprazole. The currently proposed study     will also further explore the relationship between the levels of TMC278 in the blood at     several time points and the acidity of the stomach. Also the short-term safety and     tolerability of co-administration of omeprazole 20 mg q.d. and TMC278 25 mg q.d. will be     assessed.   "
240868|NCT01001260|"     To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty     (PTCA) procedure.   "
240869|NCT01001273|"     This study proposes a simple and safe way of lowering this complicate rate, while improving     graft recovering and protecting the graft as it recovers from the transplant. The     investigators hypothesize that by maintaining a tight glucose control via a glucose-insulin     clamp during surgery and 72 hours post-operatively the investigators will be able to lower     the complication rate by 50%.   "
240918|NCT01007318|"     The aim of this study is to investigate the safety and efficacy of single port laparoscopic     appendectomy compared with conventional laparoscopic appendectomy in adults with acute     appendicitis.   "
240871|NCT01001299|"     This open-label single-arm study will evaluate the effect of RO5185426 [RG7204; PLEXXIKON:     PLX4032] on the pharmacokinetics of five CYP450 substrates (caffeine, warfarin + vitamin K,     omeprazole, dextromethorphan, midazolam) administered as a drug cocktail to patients with     metastatic melanoma. The study will also evaluate efficacy and safety of RO5185426. On day 1,     patients will receive the drug cocktail. On days 6 to 19, patients will receive RO5185426     twice daily. On day 20, patients will receive RO5185426 and the drug cocktail and on days 21     to 25, patients will receive RO5185426. Assessments will be made at regular intervals during     the dosing periods and at follow-up. Patients may continue on study treatment (RO5185426)     until the development of progressive disease or unacceptable toxicity. Target sample size     <50.   "
240872|NCT01001312|"     Heart failure is a common cardiac condition affecting nearly 6 million Americans. Silent     blood volume overload is common in patients with heart failure and is associated with     increased risk of death. This study is designed to determine if adjustment of therapy based     on direct measurement of blood volume will reduce risk of hospitalization and death when     compared with therapy based on clinical assessment of blood volume in patients with chronic     heart failure.   "
240873|NCT01001325|"     Since the onset of the 2009 pandemic, several observational public health investigations in     Canada have identified evidence that suggests that adults, particularly younger adults, who     have previously received seasonal influenza vaccine are at increased risk of infection with     the 2009 pandemic strain of H1N1 (pH1N1). Investigations in Australia, the United States and     the United Kingdom have not identified this effect. While it is not possible to have an     answer to whether this affect is real prior to the second wave of the 2009 pandemic, it     remains vital to future influenza vaccination programs that the hypothesis that, in 2009,     seasonal vaccine increases or decreases the risk of pH1N1 infection be confirmed or refuted.      The objective of this study is to determine whether Ontario adults aged 18-60 years who     receive the 2009 seasonal influenza vaccine will be at a 2 fold or greater increased risk of     infection with influenza pH1N1 during the second or third wave of the 2009 pandemic.   "
240874|NCT01001338|"     To compare the proportion of subjects whose serum urate (sUA) levels are < 6.0 mg/dL     following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to     allopurinol alone in subjects with documented inadequate hypouricemic response with standard     doses of allopurinol.   "
240875|NCT01001351|"     PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting     dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to     improve primary patency and long-term survival of AVGs and thereby provide patients with     chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis.     Recent data indicate that up to three quarters of patients have loss of graft patency at one     year, indicating a substantial need for new therapies. This clinical trial will explore the     safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly     placed upper extremity AVG.   "
240876|NCT01001364|"     This study primary objective is to compare the impact of two products containing budesonide     and formoterol as individual capsules with inhalation powder for the pulmonary function of     subjects with persistent asthma.   "
240877|NCT01001377|"     The primary objective of this study is to compare the effect of panitumumab versus cetuximab     on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among     patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.   "
240903|NCT01001728|"     A randomised, two-arm, non-blinded crossover study investigating the impact of treatment     position (prone versus supine) upon reproducibility of tumour bed position in patients     undergoing breast radiotherapy following excision of early breast cancer.   "
241898|NCT01010334|"     Patient will choose to either receive the standard of care according to National     Comprehensive Cancer Network (NCCN) or approved guidelines for their condition or to be     treated according to one arm of the protocol that they could not be enrolled on. The     selection of the arm will be at physician discretion.   "
240878|NCT01001390|"     This study is designed to see if children with acute lymphoblastic leukemia who have     developed foot drop during treatment for their leukemia consume less oxygen when walking with     or without an ankle brace designed to support their foot during walking. In this study     children with foot drop are asked to walk for six minutes with and without brace on their     ankle. During each walk, the amount of oxygen used is measured. The child wears a face mask     which is attached to a device that records how much oxygen they use. The amount of oxygen     used during the walk with the brace on will be compared to the amount of oxygen used with the     brace off.   "
240879|NCT01001403|"     This study intends to see the effect of nafamostat on the attenuation of postreperfusion     syndrome (PRS) that frequently occurs during liver transplantation.   "
240880|NCT01001429|"     The investigators would like to determine if using Dexmedetomidine alone or in a reduced dose     can prevent or reduce the incidence of adverse effects, while providing adequate sedation,     and respiratory stability as compared to propofol.   "
240881|NCT01001442|"     This Phase I/IIa clinical study is to test safety and anti-tumor activity of BT062 to define     the best dose in treating patients with relapsed or refractory multiple myeloma with multiple     doses of BT062.   "
240882|NCT01001455|"     The purpose of this study is to monitor the blood pressure level of the patient using a     preformed cuff ranged 22 cm-36 cm.   "
240883|NCT01001468|"     The purpose of this study is to examine the efficacy, safety and tolerability of VB-201 as     compared with placebo on measures of disease activity in patients with psoriasis.   "
240884|NCT01001481|"     The primary objective of this treatment review and feedback program is to quantify the risk     status for medication adherence in a cohort of Australian patients diagnosed with     schizophrenia.   "
240885|NCT01001494|"     The main purpose of this study is to assess the long term bronchodilator efficacy, safety and     tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD     patients and the benefits of the product in disease-related health status, COPD symptoms and     COPD exacerbations.   "
240886|NCT01001507|"     This is a cluster randomized trial comparing the integration of family planning services into     HIV care and treatment programs versus the standard referral for family planning services     outside of HIV care and treatment programs within Suba, Kisumu East, Rongo and Migori     districts in Nyanza province.   "
240887|NCT01001520|"     This study will test the hypothesis that a medication called tolcapone (Brand Name: Tasmar)     will help reduce cognitive problems that smokers experience when they quit. This study will     also determine whether the benefits of this medication differ depending on a smokers' genetic     background.   "
240888|NCT01001533|"     The aim of the study is to investigate the use of a new FDA-approved non-invasive     bio-impedance cardiac monitor, ICON, to detect hemodynamic effects during sedation in     children undergoing radiology procedures. The purpose of the study is to determine the     ability of the ICON monitor to identify the anticipated and documented hemodynamic changes in     children which occur in response to Dexmedetomidine sedation. The investigators postulate     that if the ICON device can trend hemodynamic changes, if any, during dexmedetomidine (DEX)     sedation in children the investigators can delineate changes in cardiac output, stroke     volume, and systemic vascular resistance associated with observed changes in heart rate and     blood pressure.   "
240889|NCT01001546|"     The overarching aim of the study is to evaluate in a randomized trial the impact of an     internet intervention compared to a standard clinic-based control group to promote smoking     cessation among Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) veterans.   "
240890|NCT01001559|"     This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with     an antidepressant is better than an antidepressant alone in adults with major depression.   "
240891|NCT01001572|"     This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill     combination in patients with uncomplicated essential hypertension not adequately controlled     (MSDBP ≥90 mmHg and <110 mmHg) on valsartan 160 mg alone.   "
240892|NCT01001585|"     Summary. At the present, the investigators do not have the perfect anesthetic for     mitochondrial patients. When possible, consideration should be given to the use of local     anesthetics in small amounts. When a general anesthetic is necessary, they each carry     significant risks and have been associated with poor outcomes. At present it is not possible     to eliminate one group as less safe than others. What is clear is that these patients must be     monitored more closely than other patients. The advent of the bispectral index (BIS) monitor     may allow us to monitor their depth of anesthesia more closely and thus expose these patients     only to the minimum amount of drug necessary to carry out the surgical procedure.      Purpose. The investigators hypothesize that specific mitochondrial diseases, in particular     those that decrease complex I function, make certain children hypersensitive to volatile     anesthetics. These same patients may be at increased risk for adverse outcomes following     general anesthesia. The specific aims of this application are:        1. Determine which molecular defects in mitochondrial function lead to alter sensitivity to          the VA sevoflurane.        2. Establish the relative safety of sevoflurane in treatment of patients with mitochondrial          disease.      The investigators plan to monitor patients with mitochondrial disease using expanded measures     of cardiovascular stability and measurements of brain electrical activity while slowly     inducing general anesthesia. The investigators will use those measurements to limit the     amount of anesthetic these patients receive in an attempt to minimize their risk. In     addition, the investigators will correlate their sensitivity to the type of mitochondrial     defect so that the investigators may be able to predict which patients are likely to have an     increased sensitivity.   "
240904|NCT01001741|"     While medication adherence is critical to successful treatment of HIV, there are few studies     of interventions demonstrating improvements in adherence. This may be a particular challenge     in the developing world, which has a larger burden of HIV but fewer resources than     industrialized countries. The investigators propose a randomized controlled trial of cellular     phone text message reminders to improve medication adherence. Our pilot study will be set in     a large HIV clinic in Gaborone, Botswana, where Penn researchers have collaborated on     research projects in the past. The primary study outcome will be antiretroviral medication     adherence.   "
240893|NCT01001598|"     Fanconi anemia (FA) and Dyskeratosis congenita (DC) are inherited bone marrow failure     syndromes. The current androgen treatments (e.g., oxymetholone) used to treat FA and DC can     cause unwanted masculinizing side effects, indicating a need for a different medication.     Danazol is a less potent androgen,and may therefore have fewer masculinizing side effects.     Danazol is currently approved by the Food and Drug Administration (FDA) for the treatment of     other diseases, but it has never been studied in patients with FA and DC.      The main purpose of this study is to see if danazol is a safe treatment for FA and DC.     Specifically,we would like to determine:        -  the best dose of danazol;        -  how fast hemoglobin (a protein that carries oxygen in the blood) levels rise in FA and          DC patients receiving danazol therapy; and        -  the genetic pattern (known as expression profile) of certain cells in response to          danazol, which can predict how well people respond to the medication.      Subjects who enroll in the study will be treated with danazol for up to 24 weeks (about 6     months), and will have up to 11 study visits, including followup visits at 38 weeks (9     months) and 52 weeks (one year).   "
240894|NCT01001611|"     The purpose of this study is to evaluate and confirm hypoglycemic efficacy and safety of     CKD-501 as mono therapy in patients with type 2 diabetes treated once daily for 24 weeks in     comparison to placebo.   "
240895|NCT01001624|"     The purpose of the study is to assess the efficacy of Melanil facial cream in the treatment     of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The     control group will receive treatment with Hydroquinone (2%). The estimated number of subjects     to be recruited and randomized for the study is 150. The primary outcome measure: Melasma     Area and Severity Index (MASI) score will be assessed at the beginning of the study and at     weeks 4, 8, 12 and 54. Photographs taken at the beginning of the study and at weeks 8, 12 and     54 will be evaluated by two independent dermatologists. Occurrence of adverse effects will     also be assessed.   "
240896|NCT01001637|"     Curcumin is shown to impact several different pathways of neuroprotection, however clinical     trials have not shown positive results, due to the poor bioavailability of curcumin. This     study is designed to determine efficacy and safety of high-bioavailability curcumin     formulation (Longvida) in subjects with Alzheimer's disease.   "
240919|NCT01007331|"     The objective of the study is to examine whether 8 weeks intervention with probiotics     influence the eczema in infants suffering from Atopic Dermatitis. Furthermore the influence     of the immunologic status and the intestinal microflora, inflammation and permeability will     be investigated.   "
240897|NCT01001650|"     The purpose of this study is to determine the safety and tolerability of a non-replicating,     metabolically active Plasmodium falciparum sporozoite (PfSPZ) vaccine in malaria-naïve     healthy volunteers following multiple-dose subcutaneous (SC) or intradermal (ID)     administration.      In addition, the investigators wish to evaluate PfSPZ vaccine-mediated protection against P.     falciparum challenge in the following 4 groups (see below) and compare protective efficacy of     the PfSPZ vaccine when given by SC v ID administration in all these groups:        -  Group 1: 4 doses of 7,500 PfSPZ/immunization,        -  Group 2: 4 doses of 30,000 PfSPZ/immunization,        -  Group 3: 4 doses of 135,000 PfSPZ/immunization        -  Group 4: 4 or 6 doses of 135,000 PfSPZ/immunization.      If > 80% protective efficacy is not achieved in Groups 1, 2, or 3, volunteers in Group 4 will     receive a fifth and sixth dose.   "
240898|NCT01001663|"     Is the FemoSeal® closure device safer and more comfortable than manual compression for     femoral artery access closure after coronary angiography?   "
240899|NCT01001676|"     Introduction: Narrowing of the draining vein occurs in >50% of hemodialysis fistula and left     untreated will lead to loss of access. The narrowing is due to excessive growth of tissue in     the vessel wall (intimal hyperplasia). The standard treatment is balloon dilatation. However,     narrowing will inevitably recur in 2-3 months hence requiring further dilatation. Intimal     hyperplasia also occurs in the heart and leg circulation. The drug paclitaxel has been used     with great success in preventing intimal hyperplasia in these vessels following balloon     dilatation. Administer locally, paclitaxel inhibits excess tissue growth in the vessel wall.     The investigators believe that this drug will have similar effect in hemodialysis access..      Objective: To assess the effect of paclitaxel in hemodialysis access with narrowing.     Paclitaxel is delivered by a paclitaxel-coated balloon. This balloon dilates the narrow     segment and simultaneously delivers paclitaxel to the vessel wall.      Methodology: Patients with narrowed hemodialysis access are dilated with the     paclitaxel-coated balloon or conventional balloon in randomized manner. The patency of the     two groups are evaluated and compared at 6 months follow-up.      Potential benefit: Decrease number of balloon dilatations and hence hospital admissions,     improve dialysis fistula function, and decrease overall economic cost.   "
240900|NCT01001689|"     Fit for Delivery is a randomized, controlled study to examine the effects of an     intervention during pregnancy which consists of exercise groups and nutritional counselling.     We intend to study 600 women who are expecting their first child, and include them in our     study at the time of their first appointment at their local healthcare clinic, when they are     between 12 and 20 weeks of pregnancy. All women who wish to participate will sign an informed     consent.      Women who are randomly assigned to the intervention group will receive two telephone     consultations with nutritional advice on healthy eating during pregnancy. They will also be     counselled about appropriate weight gain during pregnancy given their pre-pregnancy body mass     index. They will be assigned to an exercise group which will meet twice a week for a     specially designed workout, and will be encouraged to exercise once or twice weekly on their     own. Women in the intervention group will also have access to a password-protected internet     site with information on healthy living during pregnancy, and be invited to 2 or 3 evening     classes with nutritional information. Women who are randomly assigned to the control group     will receive routine pregnancy care.      All women in the study will be studied using:        -  questionaires        -  two ultrasound examinations (at 30 and 36 weeks of pregnancy),        -  blood tests, including a 2 hour glucose challenge test, and measurement of hormones          which regulate blood glucose levels        -  weighing of the participant, including use of a bioimpedance scale        -  weighing and measuring of her newborn baby,        -  blood tests from the umbilical cord, measuring hormones which regulate blood glucose          levels        -  review of hospital records regarding mode of delivery, delivery complications and          possible neonatal admissions for the newborn child.      Our hypothesis is that an intervention in the form of nutritional information and exercise     groups will:        1. Affect the amount of weight women gain in pregnancy, and the amount of weight they          retain 12 month after delivery        2. Affect the percentage of newborns who have a birthweight over 4 kilo, or who have a          birthweight at or above the 90th percentile for Norwegian newborns.        3. Affect the blood sugar level and the incidence of gestational diabetes.        4. Affect the incidence of operative deliveries and the delivery by Cesarean section.        5. Affect the serum concentrations of hormones regulating blood sugar levels, measured in          both participants and their newborns.   "
240901|NCT01001702|"     The purpose of this study is to test the long-term safety and tolerability of oral     aripiprazole in adolescent patients with schizophrenia.   "
240902|NCT01001715|"     Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain     associated with vertebral fracture.      Secondary objectives were:        -  to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral          fracture pain;        -  to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in          this population.   "
241921|NCT01010633|"     This study is being conducted to compare the safety and efficacy of loteprednol etabonate     compared to vehicle for the treatment of postoperative inflammation and pain following     cataract surgery.   "
240906|NCT01001767|"     Several studies have shown that there is an increased risk of heart disease in people with     HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid)     on improving endothelial function and decreasing inflammation which may contribute to this     increased risk. The investigators will also be doing studies to analyze coagulation and     inflammation markers.   "
240907|NCT01001780|"     Chronic graft-versus-host disease (GvHD) is a severe, life threatening complication from     getting a bone marrow or stem cell transplant. It is caused by certain cells from the donor     that attack your cells. The usual treatments, prednisone and cyclosporine, don't work very     well in chronic GVHD.      This research is being done to determine if the combination of the chemotherapeutic and     immunosuppressive, drugs pentostatin, cyclophosphamide and the monoclonal antibody rituximab,     used as in the PCR combination will prove useful in the treatment of certain patients with     chronic GvHD (namely those who are unlikely to respond to standard therapy).   "
240908|NCT01001793|"     The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory     support in heart failure patients. The purpose of this clinical study is to determine its     safety and efficacy as a bridge to transplant (BTT) in cardiac transplant candidates with     presumed non-reversible left ventricular failure.   "
240917|NCT01007305|"     This is a pilot study to assess the feasibility of conducting a randomized, blinded,     controlled trial of bilateral salpingo-oophorectomy (BSO, removal of the ovaries and     fallopian tubes) versus ovarian conservation among premenopausal women age 40 years and     greater who plan to undergo hysterectomy for a benign gynecologic condition. Subjects will be     randomized to BSO or ovarian conservation concomitant with hysterectomy and remain blinded to     group assignment. The primary goal of this pilot is to determine the feasibility of     recruiting and retaining study participants in anticipation of conducting a larger,     multi-centered trial. However, the investigators will also obtain baseline data and follow-up     measures at 6 weeks and 6 months after surgery. Outcomes will be assessed in several domains     that the investigators hypothesize may be effected by oophorectomy: cardiovascular health,     skeletal health, sexual functioning, and health-related quality-of-life.   "
240909|NCT01007201|"     This is a laboratory-blinded study in healthy toddlers, children, and teenagers designed to     investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1     vaccine (AdimFlu-S). There are 3 age strata, and each contains at least 50 subjects: greater     than or equal to 1 year to less than 3 years, greater than or equal to 3 years to less than 6     years, and greater than or equal to 6 years to less than 18 years. In each age strata, all     eligible subjects received 2 injections of AdimFlu-S (A/H1N1) at a designated dosage level     (7.5 μg, 15 μg and 15 μg for 1~<3, 3~<6 and 6~<18 years, respectively) at 3 weeks apart.      Following immunization, safety is measured by assessment of adverse events for 6 weeks     following the first vaccination, serious adverse events and new-onset chronic medical     conditions through 7 months post first vaccination, and reactogenicity to the vaccines for 7     days following each vaccination. Immunogenicity testing includes hemagglutination inhibition     (HAI) testing on serum obtained before first vaccination, and three and six weeks after first     vaccination.   "
240910|NCT01007214|"     Evaluate the accuracy of HIT guided biopsies for mapping tumor foci with men undergoing     prostatectomy.   "
240911|NCT01007227|"     Life-style intervention with dietetic and exercise therapy is an important fundamental     approach to patients with metabolic syndrome (MetSyd) which may cause endothelial dysfunction     leading to cardiovascular events. We investigated whether the life-style modification by     dietetic and exercise instruction could improve endothelial dysfunction assessed by a new     non-invasive and automatic device; digital reactive hyperemia peripheral arterial tonometry     (RH-PAT).   "
240912|NCT01007240|"     The aim of this study is to evaluate the antibacterial activity of crosslinked quaternary     ammonium polyethylenimine (PEI) nanoparticles incorporated at 1-2% w/w in a commercial soft     liner material when compared to the commercial soft liner material.      The investigators' results in vitro showed a significant delay in bacterial growth.      Therefore, the investigators assume to have the same delay in vivo- on patients.   "
240913|NCT01007253|"     People who have hayfever or allergic rhinitis often complain about eye symptoms associated     with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The     purpose of this study is to better understand the generation of eye symptoms in patients with     allergic rhinitis. We have previously shown that placing the substance that subjects are     allergic to in their nose causes both nose and eye symptoms. This can be explain by a     parasympathetic neurogenic reflex from the nose to the eye. Such a reflex would readily     explain the tearing and watery eye symptoms, but does not explain the itch. In this study, we     are going to address one possible explanation for the itch; does an axonal neurogenic reflex     stimulate mast cells in the eye to release histamine, which then causes the itch? We will do     this by placing an antihistamine drop in the eye and challenge the nose with allergen. We     will also attempt to demonstrate that mast activation isn't effected by blocking the     initiating of the reflex with a nasal steroid, as done in our previous study, and showing     that the addition of an antihistamine does not add to the reduction of symptoms.   "
240914|NCT01007266|"     Background:        -  Type 2 diabetes mellitus (T2DM) is becoming more common among youth, particularly in          minority populations. Few drug treatments are approved for T2DM in adolescents, and          behavioral and lifestyle factors may contribute to their difficulties in following          strict treatment regimens.        -  It is unknown whether a minimally invasive patient partner ( buddy ) program, which has          been developed to help improve diabetes control and quality of life, will be successful          in a population of pediatric patients with T2DM.      Objectives:        -  To evaluate the effect of a minimally invasive intervention (being assigned a patient          partner, or buddy ) on blood sugar levels in adolescents with T2DM.        -  To assess changes between groups in body weight, number of home glucose monitor checks,          compliance with medications, adherence to visit schedule, and psychological well-being.      Eligibility:      - Adolescents and young adults between 12 and 20 years of age who have been diagnosed with     type 2 diabetes and whose blood glucose control needs improvement.      Design:        -  Participants will be divided by chance into two groups: in one group, participants will          have a buddy and receive standard care; while in the other group, participants will          receive standard care alone.        -  The buddy is not a health care professional and is not authorized to provide any medical          advice.        -  Participants will be followed in the study for a total of 6 months. All study          participants will receive standard treatment for T2DM.        -  All patients will be asked to fill out a screening questionnaire (on paper or online) at          the beginning of the study and a quality of life and eating behaviors questionnaire at          the beginning and at the end of the study. These forms will include questions on medical          history, emotions, well-being, and eating habits.        -  Participants in both groups will have one diabetes clinic visit at the NIH Clinical          Center or at Children s National Medical Center (CNMC) at the beginning of the study and          two follow-up visits at the NIH or CNMC approximately 3 months apart. All visits include          a physical examination, detailed medical history, and laboratory testing which is part          of routine care for diabetes.        -  Participants assigned to the buddy group will receive phone or online messages from the          buddy once a week and will meet with the buddy once a month for less than 1 hour. The          purpose of the in-person visit is to get to know each other better outside the usual          hospital or clinic environment. The visits should take place at home, but may also take          place elsewhere, for example, at schools, cafes, or libraries chosen by both the          participant and the buddy. These face-to-face meetings may also take place at NIH or at          CNMC if this is more convenient.   "
240938|NCT01013415|"     The purpose of this study is to find out the safety and activity of an experimental anti-HIV     treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant     interleukin2). The treatments that the investigators are studying try to improve the immune     system by changing some of your T cells so they can find and destroy HIV infected cells (HIV     is usually able to hide from your T cells). In this study, the investigators are also trying     to find out if giving you more IL-2 at the same time as gene changed T cells will help the T     cells to live longer or fight HIV better.   "
240915|NCT01007279|"     An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after     otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch     occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after     PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing     obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent     studies have suggested that pretreatment with Atorvastatin may be associated with a reduction     in infarct size after elective PCI. (5-7 ).Actually the standard pretreatment in patients     undergoing elective coronary-PCI and already treated with aspirin is copidogrel loading dose     administration before procedure.(8,9 ) The investigators hypothesized that a high (40mg)     loading dose of Rosuvastatin administered within 24h before the procedure may be effective in     reducing the rate of periprocedural MI.Therefore, the investigators will conduct a single     center,prospective randomized study to assess whether a single,high (40mg) loading     (within24h)dose of Rosuvastatin is effective in preventing elevation of biomarkers of MI     after elective coronary stent implantation.   "
240916|NCT01007292|"     The purpose of this study is to evaluate response rate, survival, safety and tolerability of     YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.   "
240920|NCT01007344|"     The aim of this study is to determine if thirty grams per day of flaxseed consumption for 4     weeks could potentially reduce the serum lipid levels in children and adolescents with     familial or severe hypercholesterolemia compared to those on placebo.   "
240921|NCT01007357|"     This project will facilitate the optimization of body MR imaging at 3 Tesla.   "
240922|NCT01007370|"     The investigators aim to compare two different types of supraglottic devices for tracheal     intubation in patients undergoing elective surgery under general anesthesia.      Our hypothesis is that the use of the I-gel supraglottic airway will result in a higher first     attempt success rate of blind tracheal intubation.   "
240923|NCT01007383|"     The purpose of this first-in-man trial is to determine the safety and tolerability of     ascending single and multiple doses of LEO 27847 in healthy male subjects. The trial will be     performed in two parts. In Part 1, single doses of LEO 27847 will be administered to healthy     male subjects. In Part 2, multiple doses of LEO 27847 will be administered to healthy male     subjects.   "
240924|NCT01007396|"     The present study was to evaluate the usefulness of a whole-blood interferon-r release assays     (IGRAs) as diagnostic tool of the latent tuberculosis infection for healthcare workers.   "
240925|NCT01007409|"     To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers.   "
240926|NCT01007422|"     RATIONALE: Opioids lessen pain caused by cancer. Titration of opioids in the hospice setting     is suboptimal due to numerous barriers. Order sets may help to provide timely and effective     medical and pharmaceutical intervention.      PURPOSE: The purpose of this study was to identify barriers to good pain control in the     hospice setting and to develop an order set that would safely address these barriers.   "
240927|NCT01007435|"     This randomized, double-blind, parallel group study will assess the safety, disease     remission, and prevention of structural joint damage in patients with early moderate to     severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with     methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A)     tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4     weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks)     plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po     weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can     receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104     weeks.   "
240928|NCT01007448|"     This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy,     tolerability and safety of two initial dose levels of bexarotene capsules in patients with     refractory cutaneous T-cell lymphoma (CTCL).   "
240939|NCT01013428|"     To prospectively assess the healing process following suture of profound fexor tendon due to     traumatic rupture of FDP-Tendon in Zone II by ultrasound.   "
240940|NCT01013441|"     The purpose of this research study is to test whether giving T-cells (type of white blood     cell that are also known as immune cells) that have been specially processed in the     laboratory will help chronic lymphocytic leukemia (CLL) patients' immune system return to     normal faster after chemotherapy. This research study will also look into the ability of the     lab to process the T-cells for infusion and the side effects of giving T-cells to patients     with chronic lymphocytic leukemia (CLL).   "
240941|NCT01013454|"     This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of a     varenicline patch applied to the skin.   "
240962|NCT01013740|"     This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the     efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women     with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one     chemotherapeutic regimen in the metastatic setting.   "
240929|NCT01007461|"     Myocardial Infarctions (MI) are commonly known as heart attacks. An ST-Segment Elevation     Myocardial Infarction (STEMI) is a more severe type of heart attack. Myocardial Infarctions     happen when a coronary artery is partially or fully blocked suddenly by a blood clot, causing     damage to at least some of the heart muscle being supplied by that artery. In a STEMI, a     blood clot completely blocks the coronary artery. This can result in damage to the heart     muscle that is supplied by the affected artery. The purpose of the IK-1001 STEMI Study is to     evaluate the safety and effectiveness of an investigational study drug (IK-1001). IK-1001 is     being studied to determine if it is safe and if it can reduce the amount of damage caused to     the heart from a STEMI. Potential subjects may be eligible if they have been diagnosed with a     STEMI and undergo a primary percutaneous coronary intervention (PCI, a procedure where a     blocked coronary artery is unblocked during a cardiac catheterization), as well as meet other     entry criteria. Up to 446 men and women, aged 18-80, will participate in this study at about     50 medical sites around the world. Study participation will last for about six months.     Subjects will receive the study drug through an intravenous catheter over three hours during     their PCI procedure. Subjects will be monitored in the hospital for approximately three to     four days after the PCI. There are three follow-up visits at one, three and six months after     the PCI with the study investigator after discharge from the hospital.   "
240930|NCT01007474|"     The Italian ClinicalService Project is an integrated system composed by a network of Italian     hospital departments (for example cardiology departments), a clinical data repository (for     example, cardiovascular data) and a shared environment for the collection, management,     analysis and reporting of clinical and diagnostics data from patients treated by Medtronic     therapies or patients wearing Medtronic implantable devices used within their intended use.     The Italian ClinicalService is composed by a suite of systematic, data-guided activities     designed to bring about immediate improvements in health delivery in particular settings.     Data are prospectively collected. An independent committee of physicians prospectively     identifies key clinical questions on a yearly basis for development of quality improvement     activities, analyses and publications. A charter, approved by Hospital Istitutional Review     Boards or other Hospital entities, assigns the ownership of data to the centers and governs     the conduct of the project and the relationship of the scientific committee and Medtronic.     Hospital is the data controller, while Medtronic is the data processor on behalf of the     Hospital. Data collected for quality improvement purposes may be mined to perform     observational research.   "
240931|NCT01007487|"     Hypothesis: Plastic wound retractors reduce passage of bacteria from the abdomen to the     surgical incision site in abdominal surgery      Currently, plastic wound retractors are used in abdominal surgery to facilitate access to the     abdominal cavity. This study aims to establish whether they also prevent bacteria crossing     from the abdominal cavity to the surgical incision site. Patients undergoing abdominal     surgery in which a plastic wound retractor (Alexis®)is used are eligible for inclusion in the     study. Swabs are taken from the inside and the outside of the plastic wound retractor prior     to removing the retractor from the abdomen. The bacterial flora from swabs taken inside and     outside the plastic wound protector are then compared to see if there is any difference     between inside and outside the retractor. Bacteria are classified as 'enteric'(i.e. from the     gastrointestinal tract) or 'skin' bacteria, depending on their usual location. The study aims     to establish whether a plastic wound retractor (Alexis®) reduces translocation of enteric     bacteria to the surgical incision site.   "
240932|NCT01007500|"     The purpose of this study is to study the effect of dexamethasone combined with ondansetron     on postoperative nausea and vomiting in patients with patient-controlled analgesia after     video-assisted thoracoscopic surgery.   "
240933|NCT01007513|"     Preterm birth rate is 7.2% in Quebec, it's risen worldwide in the past decade and it's the     leading cause of perinatal mortality and morbidity. Preterm birth is a major public health     problem. Preterm labor leading to preterm birth is difficult to diagnose and prediction of     preterm birth is a medical challenge. In the past years, research found that transvaginal     ultrasound to assess the cervix of the uterus and vaginal detection of inflammatory protein,     specific bacteria and fetal fibronectin can help to detect women at increase risk of preterm     delivery. The investigators believe that a combination of these tests can lead to a better     prediction of preterm delivery. The investigators want to conduct a study among women judged     at increase risk of preterm delivery by their physician (having contractions, modified     cervix, past-history of preterm delivery or multiple pregnancy) and assess their cervix by     ultrasound and sample their vaginal secretion. The investigators want to analyze the vaginal     sampling and look for inflammatory proteins. The objective of this study is to prove the     feasibility of this assessment method and elaborate a better predictive test that the     investigators can easily use in obstetrics clinics and hospitals.   "
240934|NCT01007526|"     This study is to evaluate the efficacy of risk-adapted treatment strategy for stage I/II     extranodal NK/T cell lymphoma. The risk stratification is based on the Korean NK prognostic     index. Thus, the group I/II will receive concomitant chemoradiation followed by VIDL     chemotherapy. The group III/IV will receive high dose-chemotherapy followed by autologous     stem cell transplantation after the completion of VIDL chemotherapy.   "
240935|NCT01013376|"     The safety and comfort of repeated administrations of a topically-administered ophthalmic     formulation of MC-1101 will be established through investigator assessments and subject     reporting over a 3 day period. Safety assessments will be performed on both normal, healthy     subjects as well as those with the signs and symptoms of early non-exudative age-related     macular degeneration (dry AMD).   "
240936|NCT01013389|"     The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX     and INFUSE in achieving bone fusion.      The secondary objective of this clinical trial is to assess clinical outcome measurements.   "
240937|NCT01013402|"     The purpose of this study is to compare the accuracies and the capillary and venous     comparabilities of five different home glucose monitors; Optium Xceed, Contour Ts, Accu-chek     Go, One Touch Select and Ez Smart in an adult population.   "
240963|NCT01013753|"     The primary objective of this study is to determine the efficacy and safety of 4 doses of BI     1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in     patients with asthma in comparison to placebo.   "
240942|NCT01013467|"     Insufficient blood pressure control is a frequent problem despite the existence of effective     treatment. One of the causes is insufficient self-monitoring and a lack of adherence to     therapy. Blood pressure self-measurement at home (Home Blood Pressure Measurement, HBPM) has     positive effects on treatment adherence and is helpful in achieving the target blood     pressure.      Only a few studies have investigated whether the adherence for HBPM can be improved through     simple measures and better blood pressure monitoring can be achieved.      Objective Improvement of self-monitoring by means of blood pressure self-measurement and     improved blood pressure control by using a new colour-coded blood pressure diary   "
240943|NCT01013480|"     Study 22001, A Double-Blind, Placebo-Controlled, Flexible-Dose Evaluation of the Efficacy,     Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects with Fragile     X Syndrome currently is evaluating the efficacy of STX209 (R-baclofen) for management of     typical problem behaviors, such as irritability and aggression, in subjects with FXS. This     study (22002) will enter subjects who complete Study 22001 into a long-term, open-label     study.The open-label extension protocol will provide necessary data on the long-term safety     and tolerability of STX209 among subjects with FXS who receive treatment under conditions     more closely reflective of their general medical care.   "
240950|NCT01013584|"     Vitamin D3 is a vitamin that is an essential component of biological regulating systems in     humans. Sun exposure is the predominant source of vitamin D3. Previous research has shown     that vitamin D3 deficiency is common worldwide. It is especially common in northern countries     with long winters due to inadequate sun exposure during winter. In the US, an estimated 36%     to 57% of healthy middle-aged to elderly adults have vitamin D3 deficiency. Current research     indicates that obesity is associated with a low vitamin D3 level.   "
240951|NCT01013597|"     The purpose of this study is to evaluate the tumor response rate in patients with metastatic     medullary thyroid cancer (MTC) or radioiodine resistant differentiated thyroid cancer (DTC)     after receiving treatment with LBH589 20 mg by mouth, three times weekly. Time to     progression, overall survival, toxicity, tolerability, and Notch1 protein expression patterns     will also be evaluated.   "
240952|NCT01013610|"     To evaluate the safety, tolerability, multiple dose plasma pharmacokinetics (PK) of LNK-754     in male and female elderly volunteers after dosing with LNK-754 for 7 days and in subjects     with mild Alzheimer's Disease after dosing with LNK-754 for 28 days.   "
240983|NCT01014013|"     The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in     treatment of complicated urinary tract infections with respect to the proportion of patients     with a favorable microbiological response at 5-9 days post therapy.   "
240944|NCT01013493|"     Myopia is the main reason of vision loss in the world which is seen in 30.4 million adults in     USA (1). In a myopic eye, images are focused in front of retina because, cornea and     crystalline lens become more powerful in focusing the image or the eye axis become too long     (axial myopia) (2).      Myopia prevalence in adolescents has been raised in recent years and nowadays it has reached     to 10-25% and 60-80% in western and eastern countries respectively (3). Tehran eye study     showed that the prevalence of myopia in Tehran is 21.8% and 17.2% based on manifest and     cycloplegic refraction respectively (4). One study in Dezful, Iran showed that 3.7% of 7-15     years old children are myopic (5).      Today potential role of early life nutrition in myopia development in later life is becoming     an attractive field of study. It has been shown that until weaning; breast milk is the main     source of many nutrients [such as docosahexaenoic acid (DHA)] which are important for     photoreceptors and cortical neuronal development (6). But results about the relationship     between breastfeeding and likelihood of childhood myopia are controversial. A     hypothesis-generating study (7) showed an independent and inverse relationship between     breastfeeding and likelihood of myopia in 10-12 year old Singaporean children. However, data     pulled from three English birth cohorts done in 10-11y and 15-16y children did not show any     effect (8).      To examine the association between breastfeeding pattern and likelihood of myopia in 6-7y     children, a retrospective case-control study is designed in National Nutrition and Food     Technology research Institute of Iran. This study will try to assess breastfeeding pattern     and almost all cofactors which may relate to myopia.   "
240945|NCT01013506|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     letrozole +/- goserelin (the latter for pre-menopausal women only) may fight breast cancer by     lowering the amount of estrogen the body makes. OSI-906 and erlotinib hydrochloride may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not     yet known whether hormone therapy and OSI-906 are more effective when given with or without     erlotinib hydrochloride in treating hormone-sensitive metastatic breast cancer.      PURPOSE: This phase II trial is studying how well giving hormone therapy together with     OSI-906 with or without erlotinib hydrochloride works in treating hormone-sensitive patients     with metastatic breast cancer.   "
240946|NCT01013532|"     Through this study, the investigators are to prove that Cilostazol effectively prevent     cardiovascular events in ischemic stroke patients with high risk of cerebral hemorrhage,     along with no significant increase in the risk of occurrence of hemorrhagic side effects.      The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the     risk of cerebral hemorrhage without increase of cardiovascular events compared to aspirin in     the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage.      This study will prove the superiority of cilostazol on the prevention of cerebral hemorrhagic     events without increasing the cardiovascular events against aspirin and the superiority of     probucol on the prevention of overall cardiovascular events.   "
240947|NCT01013545|"     This study will contrast two experimental treatment conditions by testing whether joint     attention/joint engagement intervention using spoken communication (JAE-EMT) results in     better outcomes than joint attention/joint engagement intervention that is instead     supplemented with an individualized AAC system (JAE-AAC). Thus, the skills of joint     attention/joint engagement (JAE) remain foundational to developing expressive language but     the difference in the two treatments will be between whether the JAE is administered through     the more traditional spoken means (EMT) or through an augmentative and alternative     communication device (AAC).   "
240948|NCT01013558|"     The concept of fetal pain is becoming increasingly relevant due to growing possibilities for     invasive intrauterine treatment. There is much debate as to whether the fetus is mature     enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at     least capable of exhibiting a stress response to intrauterine needling. Intrauterine     transfusions are most commonly performed by inserting a needle either in the umbilical cord     root at the placental surface, or in the intrahepatic portion of the umbilical vein of the     fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in     alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These     changes were not observed in intrauterine needling in the umbilical cord root, or after     administration of analgesics to the fetus. The investigators tested the hypothesis that     remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The     investigators performed a randomised controlled trial comparing fetal stress response between     patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving     remifentanil, or placebo.   "
240961|NCT01013727|"     To study in two cross-sections of healthy volunteers, with single photon emission computed     tomography (SPECT), the possible changes generated in the mid-term by two rehabilitation     techniques: the postural reconstruction and the muscular stretching. The changes in the     cortical activation patterns will be estimated during a non-specific position of the ankle,     held static.      The influence of each technique will be estimated though the evidence of a change in the     functional mapping of the areas activated during the defined motor task on healthy     volunteers.   "
240949|NCT01013571|"     Primary Objective:      The primary objective of this study is to demonstrate non-inferiority of a patient-managed     titration algorithm (including blood glucose monitoring) for the addition of a single dose of     insulin glulisine at breakfast in Canadian patients with inadequately controlled T2DM after     optimization of basal insulin, compared with an HCP-managed titration algorithm. The primary     endpoint for assessment of this objective is the percent of patients reaching a target HbA1c     <=7.0% without severe hypoglycemia at the end of the study.      Secondary Objective:      Secondary objectives of the study are to compare the effect of the two different insulin     glulisine titration algorithms (patient-managed versus HCP-managed) on the following:        -  change in HbA1c, FG, and 7-point glucose profile at Week 24 and Week 36        -  satisfaction with treatment (DTSQc for patient and questionnaire for HCP) at Week 36        -  change in weight at Week 24 and Week 36        -  incidence of hypoglycemia        -  insulin doses        -  resource utilization (rural/urban, blood glucose meter test strips, lancets, HCP visits,          telephone calls, and hospitalizations)        -  adherence with the patient-managed monitoring algorithm   "
241262|NCT01018693|"     The purpose of the study is to determine whether VAK694 when combined with subcutaneous     immunotherapy leads to long term immune tolerance to allergen in individuals with seasonal     allergic rhinitis.   "
240953|NCT01013623|"     This study will establish the role of surgical versus nonsurgical approaches in patients     whose melanoma has spread to distant sites. Results will help clinicians develop a     standardized initial approach that prolongs survival and optimizes quality of life. Results     also will indicate whether Bacillus Calmette-Guerin (BCG) postoperative immunotherapy     significantly improves the outcome of patients treated with surgery.   "
240954|NCT01013636|"     Anaplasmosis is a tick-borne transmitted infection. Its clinical expression include fever,     cytopenia and hepatitis.This infection was initially described in United States. In Europe,     its epidemiology is not well known. Some isolated cases have been diagnosed in several     country, were the tick Ixodes ricinus is known to transmitted another infection :the Lyme     borreliosis.The purpose of our study is to look systematically for Anaplasmosis, in patient     living in Eastern France, and presenting with compatible clinical symptoms using a new     diagnosis tool : PCR in blood samples. So we will have new data about epidemiology in our     country and the clinical symptoms that are associated with Anaplasmosis.   "
240956|NCT01013662|"     Study of the lipid metabolism under glycemic control in septic patients who got an university     14 bed ICU.      Hypothesis: establish a relationship between lipid metabolism alterations and glycemic     control or infusion of exogenous insulin   "
240957|NCT01013675|"     A controlled, double-blind study to determine the immunogenicity and safety of influenza cell     derived vaccine in elderly subjects.   "
240958|NCT01013688|"     The purpose of this study is to determine whether concomitant radiofrequency Maze procedure     for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could     provide better sinus rhythm control, improved cardiac hemodynamic status and decreased     thromboembolism events and to compare if biatrial is better than left atrial procedure? 150     rheumatic valve patients with chronic atrial fibrillation (AF) having concomitant valve     surgery were randomized to three groups: left atrial ablation group, bi-atrial ablation     group, and Amiodarone group. All patients were scheduled followed up before discharge and at     3rd, 6th and 12th postoperative months. Standard 12-lead electrocardiography (ECG), 24-hour     Holter and transthoracic echocardiography were used to determine the rhythm and cardiac     hemodynamic status.   "
240959|NCT01013701|"     Fluticasone furoate is being studied to determine whether treatment with a topical nasal     steroid, in patients with existing nasal polyps , can not only improve symptoms but also     suppress the recurrence of clinically significant nasal polyp obstruction and prevent     surgical intervention.   "
240960|NCT01013714|"     The purpose of this research study is to examine the effect of cardiac sympathetic     denervation (CSD) surgery on life threatening abnormal heart rhythms called ventricular     tachycardia or ventricular fibrillation that can lead to sudden cardiac death. Subjects will     be asked to participate in this research study if they have recurrent ventricular tachycardia     (at least one ICD shock for ventricular tachycardia) and have undergone at least one catheter     ablation procedure or have ventricular tachycardia or fibrillation that is not ablatable. The     goal of this study is to determine whether cardiac sympathetic denervation can prevent these     abnormal heart rhythms from occurring and therefore, prevent, ICD shocks which are not only     painful, but have been shown to reduce quality of life and/or lead to depression,     particularly in the period immediately after the shock.   "
240964|NCT01013766|"     This study is the second administration of GSK1362885 in humans. GSK1362885 is a novel,     potent inhibitor of human glycogen phosphorylase (GP) under development for the treatment of     type 2 diabetes mellitus (T2DM). This study will investigate the compound's safety,     tolerability, pharmacokinetics, and pharmacodynamics in subjects with Type 2 Diabetes     Mellitus.   "
240965|NCT01013779|"     A Phase II Study designed to evaluate the efficacy of Chemo-Radiotherapy in achieving     loco-regional control in patients with Merkel Cell Carcinoma (MCC) of the skin. Patients will     undergo PET scans to assist in staging and planning the patient's treatment as well as     assessing response at the conclusion of treatment.   "
240966|NCT01013792|"     The primary objective is to:        -  Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with          PHI technology on wound healing in patients with a diabetic foot ulcer.      Secondary objectives are to:        -  Assess the adverse events that occur in subjects randomized to the investigational          dressing in comparison to subjects randomized to the Tegaderm Matrix Dressing with PHI          technology.        -  Assess the costs of using the investigational dressing compared to the Tegaderm Matrix          Dressing with PHI technology.        -  Assess and compare the impact that these dressings have on patients' quality of life.        -  Assess the wound's biological response and pH to the study dressings.   "
240967|NCT01013805|"     The aims of the trial are (1) to determine the tolerability rate in the setting of a     multi-centre study and (2) to determine secondary tolerability endpoints, toxicity rates and     complete pathologic response rate in patients with locally advanced rectal cancer who are     treated with an integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.   "
240968|NCT01013818|"     The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients     with relapsed or refractory lymphoid malignancies.   "
240969|NCT01013831|"     This phase I trial studies the side effects and best dose of erlotinib hydrochloride in     preventing cancer in patients with precancerous lesions of the lung. Erlotinib hydrochloride     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
240970|NCT01013844|"     This study is a behavioral science study designed to identify aspects of the dyadic     relationship that promote Skin Self-Examination (SSE) in patients at high risk of developing     melanoma. The patient is randomized to receive the educational intervention either as a solo     learner or with the partner.   "
240971|NCT01013857|"     Patients with poorly controlled hypertension will have improved hypertensive control with     telephone coaching and with telephone coaching combined with home-titration of medications.   "
240982|NCT01014000|"     Empirical implantation of the left ventricular lead is the prevailing practice in cardiac     resynchronization therapy device implantation. The response rate to the therapy has been     uniformly 70% only despite various methods to screen patients before device implantation.     This study tested the hypothesis that echocardiography to assess acute resynchronization of     the left ventricle during device implantation may improve the response rate to the therapy.   "
240972|NCT01013870|"     The purpose of this study is to improve the ability to diagnose problems after mild traumatic     brain injury (MTBI) and to test a drug that may improve the outcome from these injuries. Of     the more than 1.5 million people who experience a traumatic brain injury (TBI) each year in     the United States, as many as 75% sustain a mild TBI which can cause long-term or permanent     impairments/disabilities in a significant proportion of patients. In addition, traumatic     brain injury has become a signature injury of the wars in Iraq and Afghanistan. For people     with these injuries, it is difficult to determine whether symptoms are due to the head injury     or another condition, such as Post-traumatic Stress Disorder. In this project, there are 3     observational studies that involve testing of mental functions and behavior, imaging of the     brain with special x-ray procedures, and blood samples to look at glandular function, which     may be affected by head injury. A fourth study is a test of a drug, atorvastatin, which may     provide protection for injured brain cells and improve outcome. By collecting and analyzing     the information from these tests, it will be possible to make the process of diagnosing mild     TBI or post traumatic stress disorder (PTSD) more precise, and also to see if atorvastatin is     a helpful drug for patients with MTBI.   "
240973|NCT01013883|"     Having heart failure means the heart is unable to pump blood around the body effectively.     This reduces life expectancy and hinders normal daily activities. Heart failure affects about     one million people in the UK; it is a major cause of death but it is often undetected and     under-treated. If diagnosed and treated properly, the symptoms of heart failure can be well     controlled and the length and quality of life can be improved.      Two drugs (called ACE-inhibitors and beta-blockers) help patients to live longer and suffer     fewer consequences of heart failure. These drugs should be offered to all patients although     this does not happen consistently for a variety of reasons. Doctors specialising in heart     failure may help patients make better informed decisions about treatments and other aspects     of care.      The purpose of this research is to explore the diagnosis, management and outcome of patients     with heart failure who are referred to the one stop diagnostic heart failure clinic between     Jan 2002 and Dec 2007. This study will provide vital information about diagnosis, initiation     and titration of evidence based medication in the hospital, their follow in the primary care     and subsequent patient outcome in terms of mortality.   "
240974|NCT01013896|"     The investigators research group and others have found that patient-reported adherence to all     aspects of the regimen is suboptimal and objective measures suggest even poorer adherence.     There is little data, however that identifies and examines the reason for nonadherence in an     adult Cystic Fibrosis (CF) population or identifies effective strategies for improving     adherence.      The investigators propose to evaluate the relative efficacy of a Motivational     Interviewing-focused intervention (MI) in improving adherence and reducing CF-related     morbidity compared to a CF education intervention (CFE; attention control group).     Specifically, The investigators hypothesize that MI will result in improved regimen adherence     and reduced CF morbidity compared to the CFE control group.   "
240975|NCT01013909|"     The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable     efficacy to a Terbinafine solution applied once.   "
240976|NCT01013922|"     The purpose of this study is to explore if certain characteristics, easily detected within a     regular primary care setting, may indicate that a patient at risk for COPD (45 ≤ age ≤ 80     years and a smoking history of ≥ 15 pack years) is prone to have a diagnosis of COPD     according to Medical Products Agency guidelines.   "
240977|NCT01013935|"     The purpose of this study is to see if a computer counseling tool helps Spanish-speaking     people living with HIV to have safer sex and to do well on their HIV medicines.   "
240978|NCT01013948|"     This is a cross-sectional study to determine the prevalence of symptomatic airway obstruction     using the LFQ as a screening tool in primary care patients with a history of cigarette     smoking and to provide descriptive data of this patient population. The study design is     multicenter, cross-sectional, and involves a single visit. This study is not intended to     evaluate the efficacy or safety of any investigational products. Following completion of     written informed consent, eligible study subjects will complete a single study visit     encompassing all required study assessments. Study subjects will not receive blinded study     medication for evaluations of efficacy and safety.      All eligible patients will complete a self-administered Web survey that will include the LFQ.     To meet both the primary and secondary aims, all patients with LFQ ≤ 18 (current cut-off for     obstruction), as well as 5% of patients who score > 18, will be candidates for spirometric     assessment. Only this subset of patients will undergo pulmonary function tests. Albuterol     will be self-administered for determination of post-bronchodilator forced expiratory volume     in one-second (FEV1)/forced vital capacity (FVC) ratio and post-bronchodilator FEV1     percentage of predicted normal. The study will end when 800 patients have been assessed     spirometrically or 3,000 patients have completed the LFQ (whichever criterion is achieved     first).      Prior to implementation of the full study, a pilot study will be conducted at two of the     chosen study sites to pretest the proposed study procedures.   "
240979|NCT01013961|"     RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth     in different ways. Some block the ability of cancer cells to grow and spread. Others find     cancer cells and help kill them or carry cancer killing substances to them. Giving rituximab     together with alemtuzumab may kill more cancer cells.      PURPOSE: This randomized phase II trial is studying two different doses of rituximab to     compare how well they work when given together with alemtuzumab in treating older patients     with progressive chronic lymphocytic leukemia.   "
240980|NCT01013974|"     This is a single centre, randomized, double blind, placebo controlled, single and repeat dose     study to investigate the safety, tolerability, and pharmacokinetics of inhaled dose of     GSK573719 with lactose and containing magnesium stearate by a novel dry powder device in     healthy Japanese male subjects.   "
240981|NCT01013987|"     Phase 4, single arm, open label study designed to compare the safety and efficacy of     antiviral activity and immunological effect of Maraviroc in combination with Raltegravir and     Darunavir/Ritonavir for treatment of triple class failure in adult HIV-1 infected subjects.      The purpose of this study is to look at the safety and efficacy of a combination of 3 new     antiretroviral drugs: maraviroc, darunavir and raltegravir in patients who have     multi-resistant viruses and limited treatment options. Patients will undergo treatment for 48     weeks; safety and virological efficacy will be preliminary evaluated at weeks 16 and 24.   "
240984|NCT01014026|"     Scientific Context      High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer.     Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's     well-known that this test has significantly contributed to the reduction of mortality and     morbidity due to cervical cancer. In France, it now seems that the screening strategy could     be optimized. The two main ways are to reach the 7 million underscreened women (mass     screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA     testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA     testing could be a relevant screening option: this technique appears reliable and it could     allow to reach women who are never or seldom screened. Currently, there is no French data on     the SCVS for HPV DNA testing.      The goal of this study is to determine the performance and acceptability of a     population-based strategy using self-collected vaginal samples for HPV DNA testing to reach     women who are not participating in cervical cancer screening.      Description of the project      This project (APACHE-1) is a part of a project called APACHE. APACHE-1 will be dedicated to     the SCVS technical validation and to the comparison between different transports medium. Nine     hundred women will be recruited from the 20 to 65 years consultants in the Tours University     Hospital (CHRU of Tours) and in the IRSA (health centre for routine medical checkup).      Each woman will collect 2 SCVS with a nylon flocked swab (Copan® microRheologics™). The first     SCVS will be put in a vial which contains a liquid medium. The second SCVS will be put in a     dry vial. Then during the speculum examination the physician will collect a cervical sample     with a Rovers® Cervex-Brush™ and then rinse it into a vial containing PréservCyt ™. A blind     HPV DNA testing and genotyping (Inno-LIPA HPV Genotyping ™ Extra) will be performed in the     virology laboratory of the CHRU of Tours on all samples (SCVSs and cervical samples performed     by a physician). The performance of the SCVS to detect cervical HPV infection will be     assessed (gold standard test = HPV DNA testing on cervical samples collected by the     physician).      In a second time (APACHE-2), the researchers will investigate to what extent offering home     obtained SCVS leads to participation of unscreened women. APACHE-2 will be registered on     Clinicaltrials as another project.   "
240985|NCT01014039|"     Colonoscopy screening to reduce mortality and incidence of colorectal cancer (CRC) has been     implemented in many western countries. The estimated effect is based on case-control and     observational studies. There are no randomized trials quantifying the effect of colonoscopy     screening on CRC incidence and mortality.      The present study investigates the effect of a population-based once-only colonoscopy     screening with polypectomy on the incidence of CRC in an average risk population.      In 1983, 900 individuals 55 to 64 years of age were randomly drawn from the population     registry of Telemark county, Norway. 400 of these were invited to a flexible sigmoidoscopy     screening examination, and 400 individuals were not offered any screening. In 1996, the     remainder, both cohorts from 1983 were invited to a colonoscopy screening examination. A new     age and sex matched control group, not being offered screening, was randomly drawn from the     same registry. Both groups are to be followed with regard to CRC incidence, CRC mortality and     all-cause mortality through national Norwegian registries.   "
240986|NCT01014052|"     The purpose of this study is:        -  to evaluate the safety of oral QLT091001        -  to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in          subjects with LCA or RP due to RPE65 or LRAT mutations        -  to evaluate duration of visual function improvement (if observed)   "
241009|NCT01014351|"     Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin     (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel     with carboplatin should lead to improvements in efficacy as measured by progression-free     survival and response rate.   "
240987|NCT01014065|"     While sunitinib can be very helpful to treat kidney cancer, these medications can also cause     side effects, including heart damage. Studies performed in the past did not look at heart     function in detail, so the investigators do not know what happens to the heart when people     start sunitinib treatment. The aim of the study is to prospectively study acute effects of     sunitinib on heart function, overall fitness and blood markers of heart disease.   "
240988|NCT01014078|"     The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic     solution, 1% in dry eye subjects over a four week treatment period, using placebo as a     comparison.   "
240989|NCT01014091|"     The objective of this study is to evaluate the safety and immunogenicity study of GSK     Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9     years.   "
240990|NCT01014104|"     This study is a prospective randomized clinical controlled trial to assess the efficacy of     the Methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro     fertilization (IVF) cycles.   "
240991|NCT01014117|"     SRT2104 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic     inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The     objective of this study is to test if SRT2104 may be a novel compound for the treatment of     inflammatory disorders in man.   "
240992|NCT01014130|"     The purpose of this study is to investigate whether radiotherapy given as three large doses     over a period of two weeks (hypofractionated radiotherapy) is more effective than standard     radiotherapy for patients with non-small cell lung cancer that has not spread beyond the     lung. Although surgery is the most effective treatment for early lung cancer, many patients     are not fit enough for an operation. The alternative treatment to surgery is standard     radiotherapy which is normally 'fractionated' that is, given as a number of small doses over     a period of weeks. Experience has shown that many small treatments are safer than using a few     large doses (hypofractionation) because there is less risk of damage to normal tissues.      Recent advances in technology have however resulted in greater accuracy and with it a     reduction in the amount of normal tissue affected by the radiation, so the risks of     hypo-fractionation damaging normal tissue are of less concern. Initial results obtained with     hypo-fractionated radiotherapy for early stage non-small cell lung cancer indicate that it     may be more effective in controlling the cancer. However, it has never been compared directly     with standard fractionation in a randomised trial, so this study aims to determine if     hypo-fractionation is more effective, results in longer life expectancy and if it is just as     safe as standard fractionation.   "
240993|NCT01014143|"     Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and     an oral rinse.   "
240994|NCT01014156|"     You are admitted to hospital because of pulmonary embolism. You are treated with     anticoagulants.      The investigators know that, despite this treatment, pulmonary embolism can be a threat     especially if heart function is compromized.      The investigators investigate a well known study drug (epoprostenol) on top of regular     treatment with anticoagulants, to see if heart function can be optimized   "
241112|NCT01015690|"     Unexplained fertility could be partly caused by a higher incidence of early pregnancy loss in     this group. 65 women with unexplained infertility and 65 healthy controls will collect daily     urine samples form the luteal phase. hCG and creatinine levels are measured in order to     detect pregnancies and early pregnancy loss.   "
240995|NCT01014169|"     The delivery of anticipatory guidance is an essential component of pediatric practice. Given     the large amount of information to be shared during each encounter and the limited time     available, there is a need for an effective and efficient means of communication between     health care providers and families. The investigators hypothesize that more active parental     participation in the form of note taking during the delivery of anticipatory guidance will     lead to increased knowledge, higher levels of satisfaction with the encounter, and increased     adoption of recommended parenting practices.      In this study, the investigators propose a randomized controlled trial of the impact of note     taking during the delivery of newborn anticipatory guidance on maternal practices related to     newborn care. The investigators plan to compare a control group of mothers receiving standard     of care anticipatory guidance with an intervention group of mothers who are encouraged to     take written notes while receiving the anticipatory guidance. The primary outcome of interest     is maternal practice related to infant sleep position, and the secondary outcomes of interest     are maternal practice related to breastfeeding initiation and car seat use. The investigators     also plan to evaluate the impact of note taking on mothers' knowledge of recommended     practices related to newborn care and on mothers' satisfaction with the guidance received.   "
240996|NCT01014182|"     Several recent trials (1,2) suggest that all STEMI patients receiving fibrinolysis in non-PCI     centres should be routinely transferred for elective early PCI within 24 hours from     hospitalization, with no additive risk of major bleeding complications or other severe     adverse events compared standard therapy. These results in favour of a routine invasive     strategy in STEMI patients suggest a potential change to the current approach of awaiting the     response to treatment in patients receiving fibrinolysis, and draw the attention to the     potential need for an appropriate network organization with adequate first hospitalization     treatment (spoke) and prompt transfer to centres with 24/7 PCI capabilities (hub). The recent     ESC (3) and ACC (4) guidelines on STEMI are consistent with the early ESC PCI Guidelines,     recommending that angioplasty after fibrinolysis should be performed within a time-window     ranging between 3 and 24 hours after successful lytic administration (level evidence IIA).     The reason for the weighting of the recommendation is due to the heterogeneity of trial     results with different planned-revascularization strategies, variable primary end-points     definitions, and small individual trial sample sizes. Therefore, a consistent analysis of     single patient dataset from all published randomized trials would be of value to better     define the magnitude and duration of clinical benefit of the routine invasive strategy after     lytic treatment as well as the potential optimal timing of such a strategy.      The main aim of the OTTER meta-analysis is to define the benefits of immediate PCI after     fibrinolysis for STEMI patients. Moreover, the OTTER meta-analysis will investigate the     optimal timing of post-fibrinolysis elective revascularization.   "
241049|NCT01014871|"     Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison     study in subjects with moderate to severe forehead wrinkles.      One botulinum toxin type A will be injected in one side of the forehead and the other one     will be injected in the other side of the forehead at baseline. Allocation of each BoNT-A to     each side of the forehead will be randomized.   "
244293|NCT01047033|"     This purpose of this study is to determine whether a health education intervention for     clients of a microcredit organization in Peru will improve health outcomes among clients and     their children.   "
240997|NCT01014195|"     1. This study will evaluate the association between changes in basic cognitive and          behavioral functioning by the end of chemotherapy treatment, and the later development          of higher order executive functions in pediatric acute lymphoblastic leukemia (ALL).        2. The association between acute treatment-related changes in brain integrity and          subsequent brain maturation in long-term survivors of pediatric ALL will be evaluated.        3. The association between patterns of behavioral and executive dysfunction and brain          maturation in long-term survivors of pediatric ALL will be examined.        4. The association between genetic polymorphisms in key enzyme pathways and higher order          brain development in long-term survivors of pediatric ALL will be explored.        5. The associations between biologic and behavioral indices of fatigue/sleep and higher          order brain development in long-term survivors of pediatric ALL will be explored.   "
240998|NCT01014208|"     This study is being conducted to compare the efficacy and safety of ofatumumab in addition to     salvage chemotherapy versus rituximab in addition to salvage chemotherapy in CD20 positive     DLBCL subjects relapsing, or with persistent disease, after first-line treatment with     rituximab combined with an anthracycline-based chemotherapy regimen and be eligible for ASCT.   "
240999|NCT01014221|"     To investigate the efficacy of acupuncture compared with steroid treatment in patients with     mild-to-moderate carpal tunnel syndrome (CTS) as measured by objective changes in nerve     conduction studies (NCS) and subjective symptoms assessment in a randomized, controlled     study.   "
241000|NCT01014234|"     The immune system response is mediated by the interaction between the antigen presenting cell     (APC), CD4+ T helper cells (Th) and CD4+ CD25+ regulatory T cells, a subgroup of CD4+ T cell     which express IL-2 receptor (CD25) and the transcriptional factor foxp3. Regulatory T cell     may contribute to the maintenance of tolerance by suppressing the immune response to normal     or tumor associated antigens.      Regulatory T cell emerge from the thymus during ontogenesis and they represent about 10 % of     the peripheral Cd4+ t cells.      Rapamycin is one the most use treatment to prevent renal allograft failure. Differently from     calcineurin inhibitors (cyclosporine and tacrolimus), that inhibit T-cell activation through     the inhibition of calcineurin activation, rapamycin inhibits cellular proliferation by     impairing the progression of the cellular cycle, in particular by interaction with mTOR.     Recently Battaglia et al. have demonstrated a Treg amplification in murine CD4+ lymphocytes     treated with rapamycin in vitro.      Aim of the study is to evaluate the effect of different immunosuppressive regimens on     regulatory T cell and to verify the hypothesis that rapamycin may induce tolerance in kidney     transplanted patients, more than cyclosporine treatment.   "
241001|NCT01014247|"     The aim of this study is to investigate the effect of moxifloxacin on the QT interval in     order to gain information on the validity of results that will be collected during another     clinical study testing riociguat in patients with pulmonary arterial hypertension (PATENT-1     study).   "
241288|NCT01019044|"     Prospective study in HIV-1 infected patients with a plasma viral load below the limit of     detection and stable for at least 5 years.   "
241002|NCT01014260|"     Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in     SLE in developed countries. In a recent study the investigators have shown that high     sensitivity C reactive protein (hs-CRP) is higher in SLE patients with (versus without)     coronary calcium, a measure of subclinical atherosclerosis. In an ongoing two year     intervention trial of atorvastatin, the investigators will determine if statins retard     coronary calcium and reduce hs-CRP. However, 10% of the patients in the trial were intolerant     of statins. The investigators want to now investigate whether there are additional, and     potentially safer ways, to reduce hs-CRP in SLE. In this study, the investigators will     determine if doxycycline reduces hs-CRP and other vascular inflammatory markers including     interleukin 6 (IL-6), soluble vascular cell adhesion molecule (sVCAM-1), soluble inter cell     adhesion molecule (s-ICAM-1) and matrix metalloproteinase 9 (MMP-9) in SLE.   "
241003|NCT01014273|"     This is a multi-national, multi-centre, randomized study comparing the trans-radial PCI     access strategy and the trans-femoral PCI access strategy in ACS patients with UA or NSTEMI     or STEMI planned to be treated with an invasive strategy (PCI).      The hypothesis is that radial access site PCI will be associated with significantly less     major bleeding and access site complications compared with a femoral approach, without     increasing the risk of ischemic events. The overall benefit-risk profile will favor a     trans-radial approach.   "
241005|NCT01014299|"     The purpose of this study is to evaluate the safety and efficacy of a recruitment maneuver     immediately after intubation in hypoxemic patients.   "
241006|NCT01014312|"     This research study develop a collaborative depression care management model (C-DCM) that     encourages collaboration between primary care physicians (PCPs) and trained social workers     employed by community-based, public and nonprofit mental health clinics.   "
241007|NCT01014325|"     The objective of this clinical trial is to assess the safety and efficacy of sublingual     application of allergen extracts for specific immunotherapy in patients suffering from     perennial allergic rhinitis due to house dust mites.   "
241008|NCT01014338|"     A double blind randomised placebo controlled parallel trial of the effect of fosinopril, an     angiotensin converting enzyme inhibitor, on the quadriceps muscle in 80 COPD patients who     have quadriceps weakness. Patients will have a baseline assessment including measures of     quadriceps strength and endurance and a quadriceps biopsy. Patients with weakness will be     randomised to ACE inhibitor or placebo and re-assessed after three months of treatment.      The investigators aim to show that ACE-inhibition will alter the IGF-1/AKT/FoXO/atrogene     pathways involved in muscle wasting in COPD.   "
244294|NCT01047046|"     This study is a retrospective chart review including all patients who received surgical     placement of a SNM device with Dr. Noblett from 2001 to the present.   "
241010|NCT01014364|"     The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is     rapidly progressing worldwide and a substantial number of patients get severe H1N1 related     pneumonia that requires mechanical ventilation and admission to the intensive care unit. The     acute respiratory distress syndrome is associated with a substantial mortality and morbidity     partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are     trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these     drugs may cause super infection or metabolic disorders. Thus, there is a need for a     randomized double blind, placebo controlled trial to define the benefit to risk ratio of     corticosteroids in this patient.   "
241011|NCT01014377|"     The purpose of this study is to assess the safety and the immediate effect of the VascuActive     device on patients with peripheral vascular disease and limb ischemia.   "
241012|NCT01014390|"     The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary     RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct     strictures.   "
241013|NCT01014403|"     Brain injured patients are at high risk for forming blood clots in the legs and lungs. For     non-brain injured trauma patients, we decrease the chances of these blood clots forming by     placing the patients on a low dose of the blood thinner enoxaparin. Starting patients with a     brain injury on the blood thinner is problematic, however, as this can theoretically cause     the brain injury to worsen. Trauma surgeons wait a variable period of time before starting     this blood thinner because waiting too long can result in the formation of these blood clots     in the legs and lungs. Previous research has shown that some brain injuries which are of     lower severity can have enoxaparin started at 24 hours after injury if the brain injury is     stable on a repeated computed tomography (CT) scan of the head. This is a pilot study     designed to look at the rates of worsening of brain injury if the low dose blood thinner is     started at 24 versus 96 hours post-injury.   "
241014|NCT01014416|"     To investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of tolvaptan 15,     30 and 60 mg after single oral administration in healthy Korean male subjects.   "
241015|NCT01014429|"     The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a     polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.   "
241016|NCT01014442|"     This open-label, single center study will assess the pharmacokinetics, efficacy and safety of     mycophenolate mofetil in lung allograft recipients. Participants will be split into 2 groups     according to the original disease: Group A (cystic fibrosis) and Group B (chronic obstructive     pulmonary disease [COPD], emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin     deficiency [A1AD]). All participants will receive mycophenolate mofetil orally, 1.5 grams (g)     twice daily (BID) from Day 2 to 30 post transplantation, and 1 g BID from Day 31 to 90 post     transplantation. Anticipated time on study treatment is 90 days, and target sample size is     50-100 individuals.   "
241028|NCT01014598|"     This phase I trial studies the side effects and best dose of cisplatin in treating patients     with stage IIIB-IV non-small cell lung cancer or tumors that have spread from where they     started to the lung (metastasis). Drugs used in chemotherapy, such as cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving cisplatin directly into the     arteries around the tumor may kill more tumor cells and cause less damage to normal tissue.   "
241113|NCT01015703|"     The study is being conducted to explore the safety and tolerability of CoVaccine HT in     healthy male and female volunteers. In this study volunteers will receive intramuscular     injections of CoVaccine HT.   "
241017|NCT01014455|"     Smoking causes 90% of all lung cancer deaths among men and 80% of lung cancer deaths in     women. Surgery is a great opportunity to help patients quit smoking. Smokers are at increased     risk for heart, lung, and wound complications around the time of surgery. Even a brief     abstinence from smoking can produce benefits. Surgery can also motivate smokers to quit     spontaneously. If the investigators can take advantage of this great opportunity, they may be     able to help many smokers quit using simple means. However, currently most smokers continue     to smoke cigarette on the morning before surgery, as shown by the measurement of exhaled     carbon monoxide (CO) on the morning of surgery. CO is one of the many poisons in cigarette     smoke. It only stays in the body for a few hours. By asking smokers to blow into a small     machine, the investigators can test the CO level in the smokers' body and thus know if they     have just smoked within the past few hours. The goal of this study is to determine the role     of carbon monoxide monitoring as a means to decrease cigarette smoking before surgery. The     investigators will identify a group of smokers who are scheduled for surgery and invite them     to participate. One or two days before surgery, half of the patients will receive a brief     advice about quit smoking. The other half of patients will be told that their CO will be     checked before surgery, in addition to the brief advice. On the morning of surgery, the     investigators will then check their CO level to determine if they have followed the advice.     In order to have a better understanding about the factors influencing patients' intent to     quit smoking, the investigators will ask all study participants to fill out a questionnaire.     The questionnaire is constructed according to behavioral theories which provide good     framework for studying people's intent and behavior. If the investigators are successful,     they will determine how much of an impact the message of CO testing has on smoking before     surgery. The investigators will also gain insights into facilitators and barriers to smoking     cessation around the time of surgery. The brief intervention evaluated in this study has     potential to be disseminated and to promote the long term health of surgical patients.   "
241018|NCT01014468|"     To report the short term anatomic and visual acuity response after intravitreal injection of     bevacizumab and ranibizumab in patients with choroidal neovascularization secondary to     age-related macular degeneration.   "
241019|NCT01014481|"     To study the optimal timing to initiate antiretroviral therapy in HIV-infected patients who     are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis     treatment by comparing the composite end point of death rate, hospitalization rate and     adverse drug reactions at week 48, 96 and 144.   "
241020|NCT01014494|"     This study is being undertaken to verify the safety and performance of Adaprev™, a Class III     medical device, when administered as a short term implant into the tendon sheath at the time     of surgery, on the post-operative function of severed digital tendons. Subjects are     randomised to either Adaprev or standard care and attend visits for 26 weeks following     surgery. This clinical investigation will recruit 44 subjects in the UK at up to 10 clinical     trial sites.   "
241021|NCT01014507|"     This study is designed to test the the protective capacity of Goserelin compared with oral     contraceptive   "
241022|NCT01014520|"     The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive     analgesia to reduce postoperative pain after lumbar diskectomies.   "
241037|NCT01014715|"     The purpose of this study is to examine the feasibility to deliver PBI before the lumpectomy     is performed. By administering the PBI before the lumpectomy, a smaller volume of breast     tissue may be exposed to radiation. The PBI method used in this study is 3D (three     dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses     an x-ray beam to deliver the radiation dose. Approximately 3 weeks after completion of the     PBI, the cancer will be surgically removed.      This study will learn about the good and bad effects of 3D-conformal external beam     irradiation PBI when given before the cancer has been removed by lumpectomy. The study will     also learn about the feelings women have about how their breast looks after PBI and surgery.   "
241038|NCT01014728|"     The purpose of this study is to compare the blood loss during sinus surgery looking at two     different types of anesthesia: either intravenous anesthesia with propofol or inhalational     anesthesia with sevoflurane.   "
241023|NCT01014533|"     Insomnia and other sleep abnormalities are common, persistent, and associated with relapse in     alcohol-dependent patients. The overall, long-term objectives of the proposed research are to     investigate the neurophysiologic mechanisms of sleep disturbance that are associated with     relapse in patients with alcohol dependence, and to target those mechanisms with medication     in order to reduce relapse risk.      The specific research aims are:        1. To investigate three potential mechanisms of sleep disturbance in alcoholic patients:          impaired sleep drive, impaired circadian regulation of alertness, and brain          hyperactivation;        2. To investigate short-term effects of medication on sleep and its regulatory mechanisms          in alcoholics;        3. To investigate the short-term clinical course of alcoholism as a function of baseline          sleep parameters.      In Study Phases I & II (Screening & Baseline: 10+ days), subjects are assessed to diagnose     alcohol dependence, determine baseline values for drinking and sleeping, and rule out     confounding sleep-impairing causes.      Phase III (Medication: 10 days), is a randomized, double-blind parallel design comparison of     gabapentin vs. placebo on mechanisms of sleep. It is not a therapeutic or clinical trial.     Phases II & III each have 7 days of monitoring sleep and activity, followed by 3 nights in     the sleep laboratory to assess all-night EEG activity and Dim-Light Melatonin Onset (DLMO), a     measure of circadian rhythm.      Phase IV is a 2-day medication taper and Phase V (Follow-up) consists of one visit after 12     weeks to assess course of drinking.      In summary, sleep disturbance in alcoholic patients increases their risk of relapse. This     study proposes to investigate the mechanisms causing sleep disturbance in alcoholics and to     determine if those mechanisms predict return to drinking after 12 weeks.      Relevance: Alcoholism is a devastating chronic disorder that in any one year affects 10% of     adults, costs over $185 billion, and causes more than 100,000 deaths in the U.S. Despite     treatment, most alcoholic patients achieve only short-term abstinence. Medically-based     treatment improvements are needed that target neurophysiologic mechanisms of relapse. Overall     public health will be improved by developing science-based treatments that can augment     existing, but only partially effective, treatment approaches.   "
241024|NCT01014546|"     This phase I trial studies the side effects and best dose of arsenic trioxide with or without     ascorbic acid in treating patients with myelofibrosis. Drugs used in chemotherapy, such as     arsenic trioxide, work in different ways to stop the growth of cancer cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving     arsenic acid together with ascorbic acid may kill more cancer cells.   "
241025|NCT01014559|"     The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged     release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the     reduction of the intensity of opioid-induced constipation symptoms in patients treated for     cancer or non-cancer pain.   "
241026|NCT01014572|"     The purpose of this study is to determine whether an investigational drug (Alagebrium     (generic: ALT-711), a type of medication referred to as an advanced glycaton end-product     clever) can be combined with exercise training to reverse the stiffening of the heart that     takes place naturally with aging.   "
241027|NCT01014585|"     The purpose of this study is to evaluate the durability of effect of milnacipran for the     treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to     characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated     by changes in symptoms following the discontinuation of milnacipran.   "
241114|NCT01015716|"     The purpose of this study is to evaluate whether a 1 year worksite based life-style     intervention can reduce body weight and increase physical capacity and subsequently reduce     musculoskeletal disorders and increase workability in overweight health care workers.   "
241029|NCT01014611|"     The aim of this project is to investigate the impact of heart failure (HF) on calcium     homeostasis, mitochondrial function and oxidative stress in human skeletal muscle, before and     after exercise training. The role playing by circulating factors such as cytokines and     catecholamines will also be evaluated.      24 HF patients will be enrolled in the study: 12 class II NYHA HF volunteers with a fraction     of ejection between 40% and 30 %, and 12 class III NYHA HF volunteers with a fraction of     ejection lower than 30 %. They will be compared to 24 sedentary healthy volunteers, matched     on age and physical activity.   "
241030|NCT01014624|"     The primary objective of the study is to describe the cumulative proportion of subjects who     return to baseline platelet P2Y12 receptor function over time (up to 12 days post last     maintenance dose) following discontinuation of prasugrel 10 mg daily x 7 days assessed by     Accumetrics VerifyNow P2Y12 reaction units (PRU) and described by Kaplan Meier curves. The     primary analysis is descriptive and is intended to provide information relating to the return     of baseline platelet function following discontinuation of maintenance therapy with either     prasugrel or clopidogrel.   "
241031|NCT01014637|"     The purpose of the study is to evaluate and compare the efficacy of the sequential     association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8%     film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients     with dermatophytic onychomycosis (toenail) without matrix involvement.   "
241032|NCT01014650|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a     single IV dose of GLYX-13, an N-Methyl-D-aspartate (NMDA) receptor glycine site functional     partial agonist, in normal, healthy human volunteers.   "
241033|NCT01014663|"     The primary purpose of this study is to compare the effects of a non-traditional boxing     training program to a traditional therapeutic exercise program on activity and participation     outcomes in persons with Parkinson's disease. Thirty participants will be randomly assigned     to participate in either non-contact boxing training or traditional therapeutic exercise for     36 sessions over 12 weeks. Participants will be measured immediately before (pre-test) and     after (post-test) the intervention.   "
241034|NCT01014676|"     The purpose of this study is to evaluate the effect of regular consumption of probiotic milk     in preventing illnesses in Finnish children attending day care centres, and possible     cost-benefits that could be associated with fewer illnesses.   "
241035|NCT01014689|"     Randomized, controlled, multi-center, double-blind, parallel-group comparison study in     Subjects with moderate to severe acne vulgaris on the face.      The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide     (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl     Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of     moderate to severe acne vulgaris.      The safety of the two treatment regimens will also be evaluated.   "
241036|NCT01014702|"     The LensAR Laser System is used to create an opening in the anterior capsule of the lens and     fragments the cataractous lens. The study will evaluate clinical outcomes compared to the     contra-lateral eye treated with conventional phacoemulsification surgery.   "
241039|NCT01014741|"     Procedures for ablation of persistent or long lasting atrial fibrillation are frequently long     and require extensive ablation. Some electrophysiologists administer the drug ibutilide     during these procedures to help organize the fibrillatory activity of the left atrium with     the hope that this may shorten the length of the procedure and duration of ablation needed.     Currently there is no standardized approach of administering the drug ibutilide during these     procedures, thus the investigators cannot be certain that administering this drug does in     fact facilitate the procedure. The aim of the MAGIC-AF Trial is to see if administering a     standard dose of the drug ibutilide at a standard time in the procedure can allow for a     reduction in the ablation procedure time. The investigators hypothesize that administering     ibutilide during these procedures will result in a reduction in the procedure and ablation     time required.   "
241040|NCT01014754|"     The primary objective of this study is to determine any causative or associated factors for     the development of Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy     (NFD), or related diagnosis. Our primary focus will be on the previous administration of     gadolinium to these patients, but we will also look at other postulated causes and risk     factors.      The secondary objective of this study is to assess tissue gadolinium (Gd) levels in five     groups of subjects:        -  Those affected by NSF.        -  Those with normal kidney function who have undergone a medical imaging procedure using          Gd-based contrast agent (GBCA) in the 2 years prior to a skin biopsy.        -  Those with normal kidney function who have never been exposed to GBCA and have had a          skin biopsy.        -  Those on dialysis or with eGFR ≤ 30 ml/min/1.73 m2 who have had a medical imaging          procedure using GBCA in the 2 years prior to skin biopsy.        -  Those on dialysis or with eGFR ≤ 30 ml/min/1.73 m2 who have never been exposed to GBCA          and have had skin biopsy.      We hypothesize that there is a correlation between the administration of Gd-containing agents     usually associated with MRI procedures and the development of NSF in those with renal failure     and some other predisposing condition. We also hypothesize that tissue Gd levels in those     with NSF will be higher than in those who have been exposed to GBCA but do not have NSF. Of     the two groups without NSF but with exposure to GBCA, we hypothesize that those with kidney     dysfunction will have higher tissue Gd levels than those with normal kidney function. We     hypothesize that in the two groups of subjects without exposure to GBCA, there will be no     detectable levels of Gd, regardless of kidney function status.   "
241054|NCT01014936|"     This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore     MSC2156119J, in subjects with advanced solid tumors who have not responded to previous     therapies or for whom no other therapies are available.      Subjects will be assigned one of the dosing regimens:        -  Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment          (21-day cycle)        -  Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks          (21-day cycle)        -  Regimen 3: MSC2156119J every day for three weeks (21-day cycle)   "
241115|NCT01015729|"     The purpose of this study is to investigate whether a fixed dose combination (FDC) capsule of     esomeprazole 20 mg and acetylsalicylic acid (ASA) 81 mg has equivalent therapeutic efficacy     compared to each of 2 free combinations of ASA tablet 81 mg plus esomeprazole 20 mg in     patients at risk of gastrointestinal events using low dose ASA for cardiovascular protection.   "
241041|NCT01014767|"     This is a tissue banking and data review research study that also has a clinical research     part:        -  The goal of the tissue banking part of this study is to store tissue in a research          tissue bank by the International Society for Pediatric Oncology (SIOP) at an          international reference center for choroid plexus tumors. The tissue will be used in          future research related to cancer.        -  The goal of the data review part of this study is to collect information from the          medical records of patients with choroid plexus tumors, and to store the information in          SIOP databases for use in future research related to cancer.        -  The goal of this clinical research study is to compare 4 chemotherapy treatments for          choroid plexus tumors. The safety and level of effectiveness of these study treatments          will be compared and studied. The study drugs include different combinations of          etoposide, carboplatin, vincristine, cyclophosphamide, methotrexate, doxorubicin,          cisplatin, dactinomycin, temozolomide, and irinotecan.   "
241042|NCT01014780|"     The aim of this investigation is to determine the thickness of the human preocular tear film     using a new method based on laser speckle. This will be a preliminary study to generate     normative tear film thickness data in normal (i.e., non dry eye) and dry eye subjects in a     clinic-based population. In addition, we will examine the short term (i.e., one week)     repeatability of the method in a single setting.      The patients classified as having dry eye will also have their tear film thickness measured     after instillation of an artificial tear. This will potentially reveal valuable data in     retention of effect measured non-invasively as in prior studies that employed a fluorescein     tracer.   "
241043|NCT01014793|"     In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin     analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy     with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This     study was designed to evaluate short and long term efficacy of cabergoline in controlling     IGF-I levels in acromegalic patients receiving octreotide.   "
241044|NCT01014806|"     -  To assess the tolerability and safety of a single injection of Influenza VLP Vaccine          when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain.        -  To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA          per strain as measured by hemagglutination inhibition (HAI) antibody titers to each of          the component viral strains [A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and          B/Brisbane/60/2008].   "
241045|NCT01014819|"     The Dermacorder measures the electric field in the skin. Malignant skin lesions disrupt the     skin's normal electric field and this abnormal electric field can be detected by the     Dermacorder. Therefore the investigators are testing the hypothesis that the Dermacorder can     provide useful data to guide in the diagnosis of skin disease.   "
241046|NCT01014832|"     The purpose of this study is to evaluate the efficacy and safety of frequently modified     intensive insulin therapy in patients with Type-2 and Type-1 diabetes mellitus.   "
241047|NCT01014845|"     The primary purpose of this study is to determine whether the preventive hepatitis E are     effective in the prevention of hepatitis E occurring at least 30 days after the     administration of the third dose of vaccine.      The secondary purpose of this study is to to evaluate the safety and immunogenicity and     immunopersistence of the study vaccine.      The initial study is planed to be ended on month 19 and the results were analysed and used     for registration purpose. The extended study will be continued to assess the long-term     efficacy, immunogenicity and safety.   "
241048|NCT01014858|"     To demonstrate the superiority of donepezil over placebo in improving cognitive function,     neuropsychiatric burden and functional ability in people with Parkinson's disease and mild     dementia after 24 months of treatment.      To demonstrate the superiority of donepezil over placebo in improving patient and carer     quality of life and to establish the cost-effectiveness of donepezil.      To determine the instrument most suitable for evaluating change in cognition in people with     Parkinson's disease and mild dementia.   "
241050|NCT01014884|"     The investigators are studying the impact of the interventions of a multidisciplinary team     (MDT) - consisting of a Coventry case manager, social worker, and medical director, alongside     a Medco specialist pharmacist - on the hospitalization rates of high risk seniors with     chronic conditions, compared with a usual care approach. The study will also examine the     impact on quality of life, medication adherence, medical costs, hospital readmission rates,     and a variety of other important measures. The outcome of COSS may support a means to further     enhance and develop a comprehensive care model program by leveraging the partnership between     a health plan and a pharmacy benefit manager.   "
241051|NCT01014897|"     The hypothesis of this study is that different subgroups of stroke will respond differently     to direct current stimulation.   "
241052|NCT01014910|"     Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome cause by different types     of viruses and occurs in young children. Although bronchiolitis is a widespread and fairly     common illness in children, pediatricians vary significantly in how it is treated. This     includes how children are monitored for their oxygen status when not receiving supplemental     oxygen. Studies suggest that continuous pulse oximetry measurement of children admitted to     the hospital with bronchiolitis regardless of use of supplemental oxygen prolongs their     hospital stay. This increases the cost of care for these patients and increases their risk of     hospital-associated complications.      This study is a randomized trial of continuous pulse oximeter use in patients admitted with     bronchiolitis versus transitioning patients not requiring oxygen to intermittent pulse     oximetry monitoring. The investigators hypothesize that this will decrease length of stay as     well as associated costs of care and number of medical interventions performed in the     hospital.   "
241053|NCT01014923|"     We hypothesize that this intervention will increase the quality and quantity of parental     interaction on safety driving with newly-licensed teen drivers. 250 parent/teen dyads will be     individually randomized into intervention and control groups. The intervention group will     receive a tailored, in-person intervention with a trained member of the research team, with     follow-up intervention phone calls each month for the 3-month intervention. The control group     will be a usual care group who will receive driving safety materials available to all new     drivers and their parents. Parents and teens will be followed to see if intervention parents     meet the intervention's driving goals and to see if the parent and teens report improved     driving skills and behaviors in the intervention compared with the control group.   "
241055|NCT01014949|"     Abnormal coronary microvascular vasodilation has been demonstrated in patients with diabetes     and metabolic syndrome, but the role of insulin resistance in its pathogenesis is not clear.     The aim of this study is to invasively assess coronary microcirculation and to investigate     the relationship of insulin resistance with coronary microvascular dysfunction.      A pressure temperature-sensor-tipped coronary wire will be advanced in coronary arteries     without significant lumen reduction. Thermodilution-derived coronary flow reserve (CFR) will     be calculated as resting mean transit time (Tmn) divided by hyperemic Tmn (obtained with a     5-min i.v. infusion of adenosine 140 mg/kg/min). An index of microvascular resistance (IMR)     will be calculated as the distal coronary pressure at maximal hyperemia divided by the     inverse of the hyperemic Tmn. FFR will be calculated by the ratio of Pd/Pa at maximal     hyperemia. Insulin resistance (IR) will be assess by the homeostasis model assessment (HOMA)     index and plasma IL-6 and TNF-alpha levels will be measured in addition to routine blood     examinations before the procedure.   "
241056|NCT01014962|"     The purpose of this study is to determine an upper dose of albaconzole to be administered in     a Thorough QTc study.   "
241057|NCT01014975|"     This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the     middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot     component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter     to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg,     and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by     imaging of the affected artery and functional testing.   "
241058|NCT01014988|"     The purpose of this study is to determine whether zanamivir aqueous solution given by     intravenous injection is safe in treating hospitalized patients with confirmed influenza     infection. A single arm open-label design has been selected to achieve the primary objective     of providing regulatory authorities with safety data on IV zanamivir.   "
241059|NCT01015001|"     The primary outcome of this study is to evaluate the effects of low frequency subthreshold     repetitive Transcranial Magnetic Stimulation applied to the left temporoparietal cortex of     patients with refractory schizophrenia on the severity of auditory hallucinations.      The secondary outcome is to evaluate the effects of the same rTMS protocol on quality of     life, functionality and general psychopathology.   "
241060|NCT01015014|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile     of an antibacterial compound for treatment of hospital acquired Gram negative infection.   "
241061|NCT01015027|"     This study will test the safety and tolerability (how the body reacts to the drug) of REGN668     and placebo (an inactive substance that contains no medicine) in healthy subjects.   "
241062|NCT01015040|"     The objective of the study is to compare the relative bioavailability and pharmacokinetics of     solifenacin succinate suspension versus tablet.   "
241063|NCT01015053|"     The purpose of this study is to compare the use of ultrasound-guided bilateral rectus sheath     blocks to local infiltration of anesthetic agent in the surgical wound in a pediatric     population of patients undergoing umbilical hernia repair.   "
241121|NCT01015807|"     The purpose of this study is to determine whether a transversus abdominis plane (TAP) block     with Clonidine added to the injectate (Clo-TAP) performed approximately 2hrs after the     cesarean section (CS) will decrease the amount of postoperative hyperalgesia and ultimately     reduce post-CS chronic pain.   "
241064|NCT01015066|"     This study is designed to determine the relative effectiveness of buprenorphine/naloxone     (Suboxone) pharmacotherapy versus naltrexone pharmacotherapy for treatment retention, relapse     prevention and opioid craving reduction among opioid-dependent adolescents and young adults.     The investigators hypothesize that naltrexone treatment is as effective as     buprenorphine/naloxone for these treatment outcomes.   "
241065|NCT01015079|"     To investigate the protective effect of cervical cancer incidence and mortality by screening     attending frequency or screening pattern, and to evaluate the possible risk of developing     malignancies among women with cervical lesions, inflammation or infection.   "
241066|NCT01015092|"     The purpose of the study is to determine the main factors contributing to predicted 10 year     cardiovascular risk in an HIV infected cohort, and the role of anti-HIV drug use in altering     this risk   "
241067|NCT01015105|"     The aims of this study is to study the occurrence of the troponin elevations, ECG changes,     and cardiac symptoms in unselected consecutive patients with hip fracture.      Followup will be carried out up to one year period.   "
241068|NCT01015118|"     The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and     carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in     first-line treatment of patients with advanced ovarian cancer. Safety information about     BIBF1120/paclitaxel/carboplatin will be obtained.   "
241069|NCT01015131|"     This study correlated changes from baseline in Ki-67, an immunohistochemical marker of cell     proliferation, with changes from baseline in tumor uptake of 3'-deoxy-3'[18F]-fluorothymidine     (18F-FLT) following the first cycle of treatment with standard of care neo-adjuvant therapy     in participants with breast cancer.   "
241070|NCT01015144|"     The aim of the study was to assess of the influence of atorvastatin on selected indicators of     an inflammatory condition, function of the left ventricle and factors affecting the     occurrence of undesired events like rehospitalizations and mortality in patients with dilated     cardiomyopathy.   "
241071|NCT01015157|"     Study objectives :      Primary endpoint is to a assess the change in blood loss (originating from stapling the     stomach) with the use of Seamguard reinforcement Secondary endpoint is to evaluate the     difference in leak rate      Methods :      Prospective. Randomized study. Published data does not allow for clear determination of the     number of patients required for the study. Based on our own experience. The investigators     estimate that the average postoperative blood loss is 200ml with a standard deviation of     100ml over 3 days. Based on this assumption. A total number of patients (control + Seamguard     groups) of 60 is required if the expected reduction of the mean drainage volume is 100ml and     82 patients for an expected drainage volume reduction of 85ml.      All patients candidates to a laparoscopic gastric bypass will be enrolled in the study Under     the conditions this is a primary bariatric procedure (no revision allowed)., no history of     hiatal surgery such as anti-reflux nor significant upper abdominal surgery. The only     associated surgical procedure allowed is the cholecystectomy.      Patients' inclusion :      Will be done immediately before surgical procedure following acceptance of a written consent.      Bleeding from liver or slpeen injury will lead to patient's exclusion.      Methods :      Surgical procedures are identical for the 2 surgeons of the study (GB and PT) with 30-50ml     gastric pouch. Linear. side to side. Antegastric and antecolic gastrojejunal anstomosis . Use     of Echelon 60 linear stapler with GOLD cartridges on stomach. Blue to perform the     gastrojejunal anastomosis and white on Small bowel. Peroperativeblood loss and need to apply     clips or stitches on the gastric staple line are recorded. Operation time and patient     information (BMI. Comorbidities) are recorded as well any noticeable or unexpected event.      Postoperative blood loss is assessed by at least 1 abdominal closed circuit suction drain     left for a minimum of 3 days (removal on postop day 3 at the earliest).      In addition hemoglobin and red cell count is performed on postop day 1 and 2. Absence of     leakage is confirmed by methylene blue test perop as well as on postop day 1 before resuming     fluids and on postop day 2 by a gastrograffin swallow. Drinks and food are resumed according     to the standard practice between postop day 1 and postop day 2.      Duration of the hospital stay and postoperative course will be documented. Early follow up is     clinically done at 1 month postop without any specific radiological or biological     examination.      Data collection Will be done on a form during and after the procedure      BLOOD LOSS : peroperative volume as well as daily drainage output (postop day 1. 2 and 3) as     well as the sum of the 3 postop days.      Hemoglobin change is recorded on day 1 and 2. Need to leave drain(s) for more than 3 days is     recorded.      Study completion :      Estimated time to complete the study based on the current experience is between 5 and 7     months. Sudy is closed 1 month after the last inclusion.   "
241072|NCT01015170|"     Despite the significant health, social and economic costs of cigarette smoking, 17% of     Ontarians still currently smoke. Use of smoking cessation pharmacotherapy such as Zyban     (bupropion HCl) has been shown to double quit rates but such medications are under-utilized     by smokers attempting to quit. It has been suggested that the high price of pharmacotherapy     may act as a barrier to accessing such treatment.The main objective of this study is to     evaluate the methods and effectiveness of providing smokers who want to quit with 8 weeks of     free Zyban in combination with smoking cessation counselling through family health teams and     community health centres across the province.      Hypothesis: Ontario smokers who receive 8-weeks of free bupropion in combination with brief     counselling will have higher smoking cessation rates than the standard population cessation     rates.   "
241073|NCT01015183|"     In this double blinded randomized study we evaluate effect of Zinc sulfate for prevention     mucositis due to high dose chemotherapy in the patients undergoing bone marrow     transplantation whose received Busulfan and/or Cyclophosphamide. Patients randomized in two     groups: intervention and control with balanced block randomization method. Intervention group     received Zinc sulfate immediately after start conditioning regimen and continued for two     weeks. Control group received placebo at the same manner. Prevalence and severity of     mucositis will be compared in two groups.   "
241074|NCT01015196|"     First randomization:      After inclusion Use of Daunorubicin (arm D) or Idarubicin (arm I) as anthracyclin during all     courses of chemotherapy (induction, consolidation courses before ASCT)      Second randomization:      After achieving 1st CR: all patients received non intensive consolidation course Familial HLA     typing required for all patients      Patients with HLA-identical sibling:      Patients with very good prognostic factors (CBF leukemias, WBC < 30 giga/l at diagnosis, 1st     CR after one induction course) = arm C: no allogeneic stem cell transplantation in 1st CR;     received 2 more courses of intensive consolidation chemotherapy All others patients received     an allogeneic transplant For patients aged less than 51 = arm M: upfront myeloablative     conditioning regimen For patients aged over 51 and less than 61= arm m: intensive     chemotherapy consolidation course.   "
241075|NCT01015209|"     The dry eye syndrome DES is a highly prevalent ocular disease, in particular in the elderly     population. One mainstay of therapy for patients suffering from DES is the use of topically     administered lubricants. However, despite many efforts, no ideal formulation has yet been     found.      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for     treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with     favourable biological properties such as high biocompatibility and low toxicity.     Additionally, the new formulation comprises N-acetylcysteine, which has been used in     ophthalmology because of its mucolytic properties for several years. Based on theoretical     considerations, one can hypothesize that the new chitosan derivative may show an increased     adhesion to mucins of the ocular surface and may therefore be particularly beneficial in     reducing the symptoms associated with DES.   "
241076|NCT01015222|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of dasatinib, bevacizumab, and paclitaxel with or without Methylnaltrexone that     can be given to patients with advanced cancer. The safety of this drug combination will also     be studied.   "
241077|NCT01015235|"     The purpose of this study is to determine whether KAI-1678 is effective in the treatment of     postoperative pain following total hip or total knee replacement.   "
241078|NCT01015248|"     The aim of the study is to assess the therapeutic activity and safety of the combination of     Bendamustine and Rituximab in MALT lymphomas.      Primary endpoint:        -  Event-free-survival (EFS) (failure or death from any cause) for all patients.      Secondary endpoints:        -  Complete and partial remission rates for all patients        -  Response duration (time to relapse or progression) for responder patients        -  Progression-free-survival (PFS) (disease progression or death from lymphoma: for all          patients        -  Overall survival for all patients        -  Acute and long-term toxicity   "
241154|NCT01016197|"     The investigators are investigating if surgical treatment of injuries to the tendon which     straightens the finger tip gives a better functional outcome than treatment with a splint     while the tendon heals.   "
241079|NCT01015261|"     Patients with newly diagnosed Acute lymphoblastic leukemia after providing consent, will be     screened for eligibility. Eligible patients will be treated with Vincristine (1 mg/m2 at Day     1 and Day 8), Dexamethasone 24 mg/d day 1-15 and IT at Days 1, 4, 8 and 12. At day 14     patients will be randomized in two group. BMT group who have donor and Chemotherapy group who     don't have suitable donor. BMT group treated with allogenic Bone Marrow Transplantation and     Chemotherapy treated with Cyclophosphamide at day 15, Daunorubicin at day 15-18, Vincristine     at day 15 and 22 and Dexamethasone at day 12-28 followed by standard chemotherapy. In BMT     group patients will be received CNS radiotherapy at +100 day after transplantation.   "
241080|NCT01015274|"     The long-term objective of this research is to develop a non-invasive approach for early     assessment of which patients are at high risk for future development of skeletal muscle     atrophy. The investigators hypothesize that the rate constant for the terminal portion of the     isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine     (D-3MH) provides an accurate measure of this increased risk and that this rate constant can     be measured non-invasively from timed spot urine samples.   "
241081|NCT01015287|"     The purpose of this trial is to investigate the potential benefits/risks regarding     pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants     with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention     (PCI).   "
241082|NCT01015300|"     Von Hippel-Lindau (VHL) disease is an inherited syndrome manifested by a variety of benign     and malignant tumors. Hemangioblastomas are the most common lesion associated with VHL     disease affecting 60-84% of patients with a mean age at diagnosis of 29 years. Standard     treatment for this disease is by surgery or radiotherapy. No approved systemic therapy yet     exists. Patients with VHL have an increased growth factor production, specifically vascular     endothelial growth factor (VEGF), resulting in angiogenesis (growth of blood vessels).     Studies show that Bevacizumab inhibits the growth of VEGF protein and will block the     VEGF-driven angiogenesis and result in stabilization and regression of hemangioblastomas in     VHL disease patients. The dose of bevacizumab will be 10 mg/kg every two weeks for up to 6     months.   "
241083|NCT01015313|"     The primary aim of this study is to investigate whether intensive sodium management by     dietary sodium restriction and by preventing positive sodium balance during dialysis can be     successfully applied in chronic hemodialysis patients. Secondary aims are to test if sodium     restriction has positive effects on the frequency of hospital admissions, blood pressure,     fluid overload, quality of life and residual renal function.   "
241095|NCT01015469|"     Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY).      The aim of this novel study is to evaluate, if an additional restrictive silastic ring can     avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive     better postoperative weight loss and significantly improved long-term weight maintenance.      The study will not investigate the GaBP-Ring as medical product but the effect of the     GaBP-Ring on weight loss in comparison to gastric bypass alone.   "
241084|NCT01015326|"     Epidermal Growth Factor Receptor Inhibitors (EGFRI) are associated with skin toxicities.     Clinical experience suggests that skin toxicities interfere with health related quality of     life (HRQL) and may interfere with treatment adherence. No systematic investigations of     EGFRI-associated dermatologic toxicities and impact on HRQL have been reported. No     patient-reported outcome measures exist to capture the unique concerns of oncology patients     who experience EGFRI-associated dermatologic toxicities.      The purpose of this study is to develop a patient-reported outcomes measure to assess     dermatologic-related symptoms burden and health-related quality of life among patients     receiving an EGFRI, and to develop a grading system for EGFRI-associated dermatologic     toxicities.   "
241085|NCT01015339|"     The purpose of this study is to investigate whether Paclitaxel Plus Capecitabine With     Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is     effective and safe.   "
241086|NCT01015352|"     The study is aimed to treat low-risk MDS patients,who are dependent on red-blood cell     transfusion due to disease-related anemia, and who have a proven resistance towards treatment     with erythropoetin-stimulating agents (ESA). The study randomizes patients to receive a     treatment with the demethylating agent 5-azacytidine alone or in combination with an ESA. The     study thus evaluates, if efficacy of 5-azacytidine, notably on the red-blood cell     transfusion-dependence is comparable/inferior to a combination treatment with azacitidine and     an ESA (that is if 5-azacytidine can overcome the resistance towards ESA). Being a phase II     study, the study assesses, duration of erythroid response, overall survival and time to     progression as well as toxicity.   "
241087|NCT01015365|"     The investigators hypothesise that cementless one-stage exchange revision surgery can be     performed in patients with chronically infected hip replacement with substantial benefits for     the patients, in terms of fast rehabilitation, low re-revision rates and good long term     results.   "
241088|NCT01015378|"     Aim: This is a longitudinal cohort study to assess long-term clinical outcome of patients who     were admitted in our institution for a first episode of uncomplicated sigmoid diverticulitis.      Methods: All patients who were diagnosed with a first episode of sigmoid diverticulitis will     be evaluated for inclusion in the study, pending informed consent. Those patients who have     evidence of complicated diverticulitis (fistula, abscess) will receive a recommendation to     undergo elective sigmoid resection, while those who have a simple attack will be recruited in     the cohort. Follow-up will be performed at yearly intervals through telephone interview with     the patient. The duration of study is expected to last 10 years (2010-2020), with >50 new     patients/year, for a total of >500 patients.      Endpoints:        1. the occurrence of a second episode of diverticulitis        2. severity and outcome of recurrent diverticulitis        3. evolution in digestive symptoms and quality of life (QoL)        4. need for subsequent elective or emergency sigmoid resection      Rationale: This study will help in determining the risk/benefit of the current approach for     this common condition, which is to manage patients conservatively with antibiotics and adopt     a wait-and-see attitude. Specifically, the following events will be assessed quantitatively:        -  the rate of relapse in an urban community.        -  the burden of this common disease on QoL and digestive function        -  the percentage of patients who may need emergency surgery   "
241089|NCT01015391|"     The purpose of this study is to see whether T2 versus Azathioprine is able to maintain the     clinical and endoscopic remission in subjects with Crohn's disease after surgery-induced     remission.      The side effects related to T2 and AZA will also be monitored throughout the study.   "
241090|NCT01015404|"     This study aims to investigate the safety in using Trafermin (recombinant human basic     fibroblast growth factor) with periodontal surgery.   "
244883|NCT01061281|"     The purpose of this study is to compare the visual outcomes with bilateral implantation of     Tecnis MF and Crystalens™ AO Aberration-free Accommodating intraocular lens (IOLs) 6 months     after post cataract surgery.   "
241091|NCT01015417|"     Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic     cholecystitis little or moderately severe, is effective and therefore justified.      The main objective is to compare the occurrence of postoperative infectious complications     including surgical site infections (SSI) and remote infections after early cholecystectomy     (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC)     little or moderately serious (without organ dysfunction) with and without postoperative     antibiotics.      The secondary objectives are:        -  Rates of infectious complications according to duration of preoperative antibiotic        -  Influence of surgical drainage after surgery for occurrence of postoperative infectious          complications        -  Analysis of the nature of infectious complications (surgical site infections, remote          surgical site infections)        -  Comparison of germs found in the bile during the postoperative infectious complications        -  Duration of hospitalization        -  Readmission rate for surgical site infections        -  Rate of reoperation for surgical site infection        -  Overall mortality rate at 30 days        -  Mortality rates specific to 30 days   "
241092|NCT01015430|"     This randomized, double-blind multiple ascending dose study will evaluate the safety and     tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome.     The patients will be randomized to receive either active drug or placebo. The anticipated     time on study treatment is 6 weeks. The target sample size is <100 patients.   "
241093|NCT01015443|"     The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in     addition to best supportive care is effective in prolonging the lives of Asian subjects with     unresectable stage III non-small cell lung cancer in comparison to a placebo plus best     supportive care (a so-called placebo controlled study).   "
241094|NCT01015456|"     To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as     compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary     outcomes are complete and partial renal remission, as assessed by renal function, urinary     sediment and proteinuria in patients with International Society of Nephrology/ Renal     Pathology Society (ISN/RPS) class III or IV lupus nephritis.   "
241111|NCT01015677|"     This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of     moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal     women. The primary study hypothesis is that one or more doses of MK-6913 will result in a     significantly greater reduction from baseline, compared to placebo, in the number of moderate     to very severe hot flashes after 4 weeks of treatment.   "
241096|NCT01015482|"     Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and     leads to deterioration of quality of life. An injury or wound can lead to long term changes     in the nervous system that make the skin more sensitive at and near the injury; this is     termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the     synaptic interaction between neurons.      Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in     animal studies the investigators have discovered previously unrecognized effects of opioids.      UV-B irradaition of the skin of the thigh is an established model of priamary and secondary     hyperalgeisa in humans. The investigators want to test the influence of remifentanil, an     ultra-short acting opioid, on hyperalgesia observed after UV-B irradiation in human     volunteers in a double blind cross-over prospective active placebo controlled clinical trial,     at a dose corresponding to 0.7 µg kg-1 min-1.   "
241097|NCT01015495|"     The purpose of this study is to determine whether injections of ranibizumab into the eye are     safe and well tolerated when given to subjects in multiple doses.   "
241098|NCT01015508|"     To demonstrate differences in response of subjects with a high, low or medium predisposition     for weight regain after weight reduction in terms of: body composition; energy expenditure;     physical activity; and adipogenic capacity.   "
241099|NCT01015521|"     This is a phase II study to assess the efficacy of Aminoflavone prodrug in triple negative     and ER+ breast cancer.   "
241100|NCT01015534|"     RATIONALE        -  Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High          daily dose temozolomide combined with fractionated radiotherapy may make tumor cells          more sensible to treatment.      PURPOSE        -  This randomized phase II trial, assess in patients with brain metastases from solid          tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve          the results obtained with WBRT.   "
241101|NCT01015547|"     The objective of this study is to compare in very early polyarticular juvenile idiopathic     arthritis (JIA) the efficacy, safety, and cost-benefit-ratio of three treatment strategies:     biologic combination, combination of conventional disease-modifying drugs (DMARDs), and     methotrexate alone.   "
241102|NCT01015560|"     RATIONALE: Monoclonal antibodies, such MLN1202, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them.      PURPOSE: This phase II trial is studying how well MLN1202 works in treating patients with     bone metastases.   "
241103|NCT01015573|"     The purpose of this study is to create a database of quantified finger movements. Using the     evaluation system with magnetic sensors, the movements of finger tapping are measured and     assessed by various indices, such as finger tapping interval, maximum amplitude of finger     taps, and so on. In this study, the investigators will accumulate the data from healthy     subjects for the purpose of applying this evaluation system to diagnosis support of nervous     diseases in the future.   "
241104|NCT01015586|"     The study will determine if individuals with co-occurring bipolar disorder and alcohol     dependence report reduced alcohol consumption, improvement in mood symptoms, and cognitive     performance if treated with lamotrigine plus their usual mood stabilizing medications     relative to subjects treated with placebo plus usual mood stabilizing medications over a 16     week period.   "
241155|NCT01016210|"     To explore whether recombinant LH (rLH) supplementation (Leuveris) to recombinant follicle     stimulating hormone (rFSH) following GnRH antagonist treatment has an advantage in infertile     women with advanced reproductive ageing undergoing IVF-ET.   "
245941|NCT01074632|"     The objective of this study is to evaluate the effect of calorie and fat content on the     pharmacokinetics of Lurasidone HCl in subjects with schizophrenia, schizoaffective disorder,     or schizophreniform disorder.   "
241105|NCT01015599|"     This study presents evaluates the effectiveness of the Healthy Opportunities for Physical     Activity(HOP'N) After-School Program on preventing obesity in children. The investigators     hypothesized that normal and overweight/obese children attending after-school sites     randomized to the control condition will increase in weight status to a greater extent     compared to children at sites randomized to receive the HOP'N program. The investigators also     hypothesized that after-school intervention HOP'N sites will increase in physical activity     and healthful eating opportunities compared to control sites.   "
241106|NCT01015612|"     To evaluate the performance, efficacy and safety of the percutaneous implantation of the     CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve     stenosis that have an elevated surgical risk   "
241107|NCT01015625|"     Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of     local therapy   "
241108|NCT01015638|"     This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy     volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test     products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide     2.5% and the other side of the face will remain non-treated to serve as a control.   "
241109|NCT01015651|"     The aim of the study is to assess the accuracy of a new paradigm in measuring the level of     nociception during lumbar surgery. The paradigm is based the measurement of the baroreflex in     response to noxious stimuli in anesthetized patients.   "
241110|NCT01015664|"     This study will accrue in two phases. During the first phase of the study, the optimal     dose of temsirolimus in combination with cisplatin and cetuximab will be determined. It is     expected that between 9-12 patients will be needed for this dose finding phase. Once the     optimal dose has been determined, an additional 41 patients will be enrolled in the second     phase of the study. The primary purpose of second phase of the study is to learn what     effects, good and/or bad, temsirolimus in combination with cisplatin and cetuximab has on     recurrent or metastatic head and neck cancer.      Collection of additional blood and tissue specimens will make it possible to do special     tests, which will provide us information about how tumors respond to the chemotherapy, how     your body breaks down and processes the drug, how differences in the genetic makeup of each     person affects how the drug may work and is processed in the body, and how the drug affects     proteins and cells in the body. We hope to determine if results of the specialized tests done     on blood will help to predict which patients are more likely to benefit from the use of the     drugs used in this study.   "
241116|NCT01015742|"     The purpose of this study is to determine the safety and feasibility of unrelated double     umbilical cord blood units Transplantation in patients with haematological malignancies using     Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin,     methylprednisolone as GVHD prophylaxis.   "
241117|NCT01015755|"     Patients in Intensive Care Units are often extremely thirsty due to their medicines, illness,     treatments or medicines that they receive. This study will test whether patients who receive     a easy to implement intervention for thirst will have greater relief from thirst than a group     of patients who do not receive the intervention. The study will also identify the most     important factors that make ICU patients thirsty so that future research studies can test how     to relieve those factors and/or make interventions for thirst more readily available.   "
241118|NCT01015768|"     The purpose of this study is to assess corneal staining and to measure the relative corneal     epithelial barrier function (the degree to which the cornea can prevent penetration of     colored sodium fluorescein dye into the eye) after 8 hours of wear with a known soft contact     lens and multipurpose lens care solution combination.   "
241119|NCT01015781|"     This multi-site study evaluated the implementation of Progressive Tinnitus Management (PTM),     which combines both Audiology and Psychology approaches to Tinnitus Management. Those     Veterans who require intervention for tinnitus have different levels of need, and this     progressive approach gives them the appropriate level of intervention.   "
241120|NCT01015794|"     In this study the investigators aim to quantitate the extent of cervical and upper thoracic     brown adipose tissue (BAT) activation in lean and obese humans via positron emission     tomography-computed tomography (PET-CT) in response to the non-specific beta adrenergic     receptor (AR) agonist ephedrine. The investigators hypothesise that this pharmacological     adrenergic stimulus will result in activation of BAT in these participants, and that this     activation will be reduced in obese patients. This study will provide important preliminary     information with respect to allowing the investigators to progress with longer trials with     specific beta 3 AR agonists.   "
242028|NCT01023945|"     The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose     and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety,     tolerability and pharmacokinetics are also evaluated.   "
241122|NCT01015820|"     Pancreatic cancer is the fourth leading cause of cancer death in the United States and is     associated with a poor prognosis. The average life expectancy after diagnosis is     approximately 5 to 8 months. At present, successful surgical resection is the only curative     therapy that can improve long-term survival. However, it can be achieved only when a tumor is     detected at an early stage. Unfortunately, due to non-specific symptoms associated with     pancreatic cancer, it is commonly detected in the later stages of the disease.      The investigators hypothesized that pancreatic cancer could be detected by measuring the     changes in the early increase in blood supply (EIBS) found in the surrounding     normal-appearing duodenal tissue. The investigators tested a device called Four-dimensional     Elastic Light-Scattering Fingerprinting (4D-ELF). The device used in this study is considered     investigational, which means it has either not been approved by the Food and Drug     Administration (FDA) for routine clinical use or for the use described in this study. However     the FDA allowed the use of this device in this research study.   "
241123|NCT01015833|"     This randomized phase III trial studies sorafenib tosylate and doxorubicin hydrochloride to     see how well they work compared with sorafenib tosylate alone in treating patients with liver     cancer that has spread to nearby tissue or lymph nodes or has spread to other places in the     body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. It is not yet known whether     giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than     sorafenib tosylate alone in treating liver cancer.   "
241124|NCT01015846|"     This study evaluates the ability of the transverse abdominis (TrA) to contract during and     after two different types of exercise - either sling based exercise or traditional core     stability exercise. The TrA is measured by real time ultrasound imaging. The investigators     hypothesized that the sling based exercise would activate the TrA to a greater degree and     that there would be a greater activation after the exercise.   "
241125|NCT01004627|"     Dialysis patients have their blood filtered by a machine as their kidneys no longer work. To     get blood in and out of these patients it is possible to perform a surgical procedure to     increase to size and durability of a vein in the arm to allow repeated needle insertion. This     enlarged vein is called a fistula. There is some evidence that ultrasound scanning the blood     vessels in the arm before surgery can improve the chances of a successful procedure. The     investigators aim to test whether scanning all patients is better than scanning only those     who are difficult to assess by physical examination alone.   "
241126|NCT01004640|"     RATIONALE: Studying samples of blood and bone marrow from patients with cancer may help     doctors identify biomarkers related to cancer.      PURPOSE: This research study is looking at blood and bone marrow samples in patients with     chronic myelogenous leukemia enrolled on a CALGB clinical trial.   "
241127|NCT01004653|"     A single center, Open-Label phase IV clinical trial is to be conducted in healthy elders     (equal to or more than 61 years to evaluate the immunogenicity and safety of Sinovac's 15μg     H1N1 influenza A Vaccine (Split virion), Inactivated.   "
241128|NCT01004666|"     Detection of breast cancer as early as possible is an ongoing imaging challenge.The purpose     of the current study is to assess the clinical performance of the new scintigraphic     technology, a dedicated breast gamma camera composed by the new generation of CZT     detectors,for assessment of breast pathology specifically in women where current imaging     techniques, mainly mammography are suboptimal. These cohort are patients with dense breast     tissue and patients who are at high risk for breast cancer by a combination of other metrics,     including family history and genetic testing. BRCA (breast cancer susceptibility gene), is     particularly a relevant health problem among Ashkenazi Jews in Israel.   "
241289|NCT01019057|"     Patients diagnosed with single-level degenerative disc disease (DDD) of the lumbar spine     undergo a posterior decompression followed by a fusion complete with a spinous process plate,     graft, and a biologic.   "
241129|NCT01004692|"     Rationale: The effect of vertical dimension on sleep apnoea and respiratory variables in     obstructive sleep apnoea patients.      Objective: To what extend should a possible worsening of the OSA condition, caused by an     increase of mouth opening be taken into consideration in daily dental practice, when an     occlusal stabilization splint (OSS) is placed in the mouth.      Study design: Cross over RCT-design Study population: OSA patients referred to ACTA from the     Slotervaart Hospital, for treatment with a Mandibular Advancement Device (MAD), at least 18     years old.      Intervention: Occlusal stabilization splint (OSS) for the upper jaw and a controlled     condition in a cross-over design Main study parameters/endpoints: Apnoea- Hypopnoea Index     (AHI) and the Epworth Sleepiness Scale (ESS).      The aim of this study is to determine the effect of vertical dimension of OS on sleep and     respiratory variables in OSA patients. The hypothesis is that insertion of an OSS and an     increase of the vertical dimension will result in a significant increase in the AHI.   "
241130|NCT01015859|"     The aims of this study are to assess the clinical benefits resulting from SafeR by comparison     with standard dual chamber programming (DDD) with a long atrioventricular (AV) delay.      The benefits will be assessed by comparing the percentage of ventricular pacing, the     incidence of atrial arrhythmias, and the evolution of the hemodynamic status as observed     through echo parameter and atrial natriuretic peptide/brain natriuretic peptide (ANP/BNP)     measurements.   "
241131|NCT01015872|"     The purpose of this study is to evaluate the relationships between prostanoids and various     outcomes such as sleep disturbance, hypertension and arteriosclerosis in patients with sleep     apnea syndrome(SAS). In the patients introduced to continuous positive airway pressure(CPAP)     treatment, the effects of CPAP are also evaluated.   "
241132|NCT01015898|"     The purpose of this study is to evaluate the efficacy of photodynamic therapy in treatment of     Basal cell carcinoma (BCC) and factors that affect response rate.   "
241133|NCT01015911|"     This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of     SGN-75 in patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or     metastatic renal cell carcinoma.   "
241134|NCT01015924|"     The purpose of this study is to compare two widely used operative techniques on displaced     midshaft clavicular fractures. The hypothesis is that there is no difference in functional     outcome.   "
241135|NCT01015937|"     The purpose of this study is to investigate whether turmeric is effective in improvement of     diabetic nephropathy and in decrease in the amount of proteinuria and cytokine levels.   "
241136|NCT01015950|"     The objectives of the study are to assess the impact of different dietary strategies for the     management of children with MAM on: the children's continued participation in the nutritional     rehabilitation program and their physical growth, recovery from MAM, and change in     micronutrient status and body composition. The specific dietary regimens that will be     compared are: 1) a ready-to-use, lipid-based supplementary food (Plumpy'Sup, Nutriset, Inc.),     providing ~500 kcal/d for 12 weeks; 2) specially formulated CSB for malnourished children,     providing ~ 500 kcal/d for 12 weeks; 3) Misola, a locally produced, micronutrient-fortified,     cereal-legume blend, providing ~500 kcal/d for 12 weeks; or 4) packaged, home available foods     (millet and cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder (Mix     Me) for 12 weeks, as is currently recommended by the national CMAM protocol when special     foods are not available.   "
241137|NCT01015963|"     This research trial studies deoxyribonucleic acid (DNA) in blood samples from Caucasian and     African-American cancer patients who received docetaxel on clinical trial CLB-9871. Studying     samples of blood from patients with cancer in the laboratory may help doctors learn more     about changes that occur in DNA and identify biomarkers related to cancer. It may also help     doctors learn more about how docetaxel is used by the body.   "
241138|NCT01015976|"     The purpose of this study is to determine the difference, if any, in the area under the     sertraline plasma level time curve (AUC) between patients who are nine to fifteen months post     Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and     gender.   "
241139|NCT01015989|"     The purpose of this study is to see if a computerized counseling tool helps patients reduce     their sexual transmission risk and improve their antiretroviral adherence.   "
241140|NCT01016002|"     The purpose of this study is to assess efficacy and safety of Foscan (temoporfin)     photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma     without distant metastases.   "
241141|NCT01016015|"     This phase II trial studies how well temsirolimus and cixutumumab works in treating patients     with locally advanced, metastatic, or recurrent soft tissue sarcoma or bone sarcoma.     Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth by blocking     the ability of tumor cells to grow and spread. Giving temsirolimus with cixutumumab may be an     effective treatment for soft tissue or bone sarcoma.   "
241142|NCT01016028|"     The goal of this research study is to learn more about pain and other symptoms that patients     may experience while receiving chemotherapy treatment with platinum agents, taxanes, and/or     bortezomib.   "
241143|NCT01016041|"     Instead of treating in-stent restenosis, the best strategy for patients is preventing     in-stent restenosis. Recent advances in the understanding of the cellular mechanism     responsible for smooth muscle cell proliferation (neointimal hyperplasia), together with     improvement in stent coating and eluting technology have provided the scientific background     to develop drug eluting stents. Drug eluting stents (DES) are now the most promising     development in interventional cardiology. Different classes of drugs mounted in a polymer     layer on the surface of the stent have shown to be very effective in preventing neointimal     hyperplasia. Currently there are 7 DES stents CE marked and commercially available on the     market. Two stents, respectively the sirolimus eluting Cypher™ stent and the paclitaxel     eluting Taxus™ stent, are in clinical use since 2002. The Cypher™ stent consists of the Bx     sonic stent/balloon platform. The stent is coated with a non-degradable biocompatible     PBMA/PEVA polymer which elutes sirolimius. The Taxus™ stent consists of the Express2     balloon/stent platform coated with non-degradable biocompatible Translute™ polymer which     elutes paclitaxel.      Recent large randomized trials like RAVEL, SIRIUS, E-SIRIUS C-SIRIUS (Cypher™ versus bare     metal BX sonic™ stent), TAXUS II, IV, V, VI (Taxus versus bare metal Express™ stent) have     shown that DES dramatically reduce the incidence of in-stent restenosis and subsequently the     need for target lesion revascularization in patients with non complex and moderate long     de-novo coronary lesions in vessels with a diameter between 2.5 -3.5 mm.1-11 Considering the     very encouraging results of these early clinical trials with so far mid long term follow-up,     there is the need to explore the utilization of DES in the other subsets of coronary lesions     like: long lesions, chronic total occlusions, venous graft lesions, thrombotic lesions,     restenosis lesions, ostial and bifurcation lesions and lesions in large vessels.      As the result from the previous reported randomized trials, FDA and other regulatory     institutes require that new DES are now being evaluated against one of the former DES (Cypher     or Taxus). The XIENCE-V stent is a second generation DES, with thinner and more flexible     Cobalt-Chromium stent struts, compared to the first generation Stainless Steel stent struts     of Cypher and Taxus. This study addresses the questions whether the XIENCE-V™ stent has     superior clinical results as the Taxus™ stent in the general population that is being     referred for percutaneous coronary intervention (PCI).      Objective of the study:      The main objective of the study is a head tot head comparison of the everolimus coated     XIENCE-V™ stent with the paclitaxel coated TAXUS™ stent in order to observe whether there is     a difference in clinical outcome between both stents.      Efficacy of both stents will be assessed by the composite end point of: all death, non fatal     myocardial infarction and target vessel revascularization.      Study design:      Single center, randomised, open label study in all-comers referred for PCI.      Study population:      Approximately 1600 consecutive patients with coronary artery disease who are eligible     according to the in- and exclusion criteria will be enrolled and randomized on a 1:1 basis.      Primary study parameters/outcome of the study:      The primary end point of the study is the composite end point of: all death, non fatal     myocardial infarction, target vessel revascularization at 1 year.      Secondary study parameters/outcome of the study:      The secondary end points of the study are:      A) The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven     target lesion revascularization (TLR) rate at 1, 6 and 12 months follow-up.      B) The combined endpoint of all death, non fatal myocardial infarction, target vessel     revascularization (TVR) rate at 2, 3, 4 and 5 years.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      The burden for the patient consists of filling in 8 questionnaires (1 A4 per questionnaire)     in 5 years time.      The first 3 questionnaires in the first year are also requested for monitoring purposes by     the Ministry of Health and the Dutch Cardiology Society (Nederlandse Vereniging Voor     Cardiologie; NVVC).      There is no risk for the patient related to participation in this study. The patient will     receive a Taxus or Xience-V stent anyhow, if the indication for a DES stent exists.   "
241144|NCT01016054|"     This is a parallel arm study to evaluate AGS-8M4 administered in combination with     chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion     until disease worsens.   "
241145|NCT01016067|"     Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to     autograft in the treatment of tibial delayed healing.   "
241146|NCT01016080|"     Oral and intravenous glutathione have been used widely to whiten the skin. The investigators     tested this hypothesis by giving oral glutathione for 4 weeks to medical students.   "
241147|NCT01016093|"     This is prospective randomized, double blind study designed to evaluate the use of zoledronic     acid in the prevention prevention of bone loss post allogenic BMT done for beta-thalassemia     major patients.   "
241178|NCT01017588|"     This study aims to evaluate the efficacy of lumbar support for low back pain prevention in     rubber tapper. The investigators will randomized the participants(rubber tapper) into 2     groups;lumbar support and no support.The participant will be instructed for brace use. The     sample size required are 200 subjects with 100 in each group. The subject will be evaluated     every 3 month for the incidence of low back pain and quality of life after using the support.   "
241148|NCT01016106|"     The investigators' primary objective is to identify common and rare mutations in the     filaggrin gene in African American patients with a diagnosis of atopic dermatitis and     ichthyosis vulgaris. Atopic dermatitis, or eczema, is a common, chronic, relapsing and     remitting problem in many children and affects 10-20% of the pediatric population. Itch is a     predominant feature of this disease and is quite disruptive to daily activities of life. In     addition to itch, it is characterized by markedly dry skin, small red bumps that may have     fluid. Ichthyosis vulgaris is characterized by extremely dry, scaly skin with a fine white     scale and increased amounts of lines noted on the palms. Filaggrin is a protein that is     essential for the skin to function properly as a barrier and found to be mutated in some     European patients with ichthyosis vulgaris and atopic dermatitis. This association has not     been looked at in the African American population. Genomic DNA (gDNA) will be purified from     buccal swabs using commercially available kits and analyzed.   "
241149|NCT01016119|"     The purpose of the study is to evaluate whether Folrex, could improve the motor recovery of     the upper extremity after stroke in comparison with placebo during 4 weeks of treatment.   "
241150|NCT01016132|"     The purpose of this study is to assess the performance of an investigational contact lens     among contact lens wearers.   "
241151|NCT01016145|"     The objective of this study is to evaluate predictors of response to antipsychotic medication     in subjects with schizophrenia. The investigators will evaluate psychopathology,brain MRI,     genetics and neuropsychological profile. Two groups of treatment will be compared: first     generation antipsychotics vs. second generation antipsychotics. Participants will be     randomized to one of the groups. Trial duration: 12 weeks.   "
241152|NCT01016158|"     In the present study, the investigators investigated the efficacy of umbilical cord serum eye     drops for the treatment of patients with recurrent corneal erosions. Group A were treated     with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears,     and group B were treated with artificial tears only. Ophthalmic examinations including visual     acuity measurement and slit lamp biomicroscopy were performed before and every month after     treatment. Recurrence was defined as the presence of clinical symptoms accompanied by     epithelial defects in the cornea.   "
241153|NCT01016184|"     Vitamin D has multiple systemic effects: bone and calcium metabolism, muscle function,     insulin responsiveness, body-composition regulation, cell differentiation, and the immune     system. Proper status of vitamin D is found to be related to risk reduction in hypertension,     cardiac and vascular diseases, autoimmune diseases, and others. Furthermore, vitamin D     supplementation resulted in improved endothelial function. Limited sun exposure may lead to     vitamin D deficiency, and it may be assumed that modern life styles lead to a lack of sun     exposure. Long work-days may be the primary risk factor for vitamin D deficiency. The purpose     of this research is to study the effect of vitamin D treatment on multi systemic functions in     young healthy men with vitamin D deficiency due to working conditions.   "
241156|NCT01017302|"     This randomized, double-blind, placebo-controlled study will evaluate the safety,     tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type     2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the     study. There will be a 5-weeks exenatide run in period and a 5-weeks period when     co-administered with the study drug. RO5095932 will be administered subcutaneously as a     single dose or as escalating doses. Patients will be randomized to receive either active drug     or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4     weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5.     Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of     active drug in week 5. The anticipated time of study treatment is <6 months. The target     sample size is <100 patients.   "
241157|NCT01017315|"     This study aims to evaluate the efficacy of baby talcum in prevent pruritus after cast     application in orthopaedic patients.      The investigators will do a randomized controlled trial in patient with fracture distal end     of radius treated conservatively.      Pruritus score and satisfaction will be monitor along the entire course of cast retention.   "
241158|NCT01017328|"     Effect of head rotation on overlap and relative position of internal jugular vein to carotid     artery in infants and children: A study of the anatomy using ultrasonography.   "
241159|NCT01017341|"     This study aims to evaluate the efficacy of the investigators PSU hip protector for     prevention of fracture in elderly.The eligible patients include those with previous diagnosed     as unilateral hip fracture. They will be randomized into 2 groups;psu hip protector and no     protector. The patients will be instructed to wear the protector fulltime.The inceidence of     hip fracture will be compared between both group at the end of 1 year.   "
241160|NCT01017354|"     This project was designed to optimizing vitamin D status in prefrail seniors age 70+ living     at home and prevent their functional decline. We test 3 arms of monthly vitamin D     supplementation. Intermittent dosing will improve adherence and simplify vitamin D     supplementation.   "
241161|NCT01017367|"     The purpose of this study is to:        1. determine the American College of Rheumatology (ACR) 20 response rate at Day 85 in          subjects with active rheumatoid arthritis(RA) administered MDX 1100 with methotrexate          (MTX); and        2. determine the tolerability and safety of multiple doses of MDX-1100 in combination with          MTX in subjects with active RA.   "
241162|NCT01017380|"     The aims of this study was to compare analgesic efficacy of preoperative administration of     etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior     cruciate ligament reconstruction. One hundred and two patients diagnosed as anterior cruciate     ligament injury will randomized into 3 groups using opaque envelope. Both patients and     surgeon were blinded to the allocation. All of the patients will be operated by one     orthopaedic surgeon under regional anesthesia. Each group will be given either etoricoxib 120     mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. Post-operative pain     intensity, time to first dose of analgesic requirement and numbers of analgesic used for     rescue pain control and adverse events will be recorded periodically to 48 hours after     surgery.   "
241217|NCT01018108|"     RATIONALE: New imaging procedures, such as single photon emission computed tomography, may     help in learning how acupuncture affects serotonin levels in the brain of breast cancer     survivors. PURPOSE: This phase I trial is studying the best way to visualize the effect of     acupuncture on brain serotonin in breast cancer survivors.   "
241163|NCT01017393|"     Chronic post-thoracotomy pain is the most common long-term complication that occurs after a     thoracotomy with a reported incidence of up to 80%. While thoracic epidural analgesia has     become the mainstay for managing acute post-thoracotomy pain, its effect on the chronic     post-thoracotomy pain seems questionable. The objective of this prospective, double-blinded,     randomized, controlled trial was to assess the effect of preemptive low-dose epidural     ketamine in addition to preemptive thoracic epidural analgesia on the incidence of chronic     post-thoracotomy pain.   "
241164|NCT01017406|"     The investigators study aim to evaluate the efficacy of PSU heel cushion in treatment of     plantar fasciitis. The investigators will do a randomized controlled trial in patient with     plantar fasciitis compared with stretching exercise alone. The outcome measurement include     heel pain improvement, compliance, satisfaction, foot functional score at 6 months.   "
241165|NCT01017419|"     Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are     retained by new hearing aid users and analyze whether age, degree of hearing loss, academic     and socio-economics status have an influence on this   "
241166|NCT01017432|"     Many elderly patients have multiple medications and variable dosing regimens and the ability     for hospitals to properly reconcile medications between what is given on paper to the patient     and what the patients take at home depends on the patient's ability to get the medications.     Some patients may delay in getting their medications from the pharmacy after being     discharged. For some it may be a lack of transportation, others may feel too ill to travel     and may not have family members who will be able to pick up the medications.      It is for these reasons the authors of this study want to inventory the medications that an     elderly patient is being discharged on during a home visit and check on the actual     prescriptions that a patient has at their house the following 1-2 days after discharge.   "
241167|NCT01017445|"     This study aims to compare the efficacy between Boonme stick exercise and quadriceps     strengthening exercise in knee osteoarthritis.Patients diagnosed as knee osteoarthritis using     Altman criteria will be randomized into 2 groups using simple random technique. Patients will     be instructed and trained for both quadriceps or Boonme stick exercise by one-trained     physical therapist. All patients will be treated with behavioral modification, NSAIDs and     analgesic drugs and regularly follow-up . Assessment included visual analogue scale, exercise     compliance, WOMAC and patient satisfaction were done by an assessor in a blinded fashion.   "
241168|NCT01017458|"     This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of     MK0773 in healthy older men.   "
241169|NCT01017471|"     The investigators study aims to evaluate both efficacy and safety of carpal tunnel release     using limited incision with the PSU retractor compared to standard incision.      The investigators will do a randomized controlled trial in 60 patients with carpal tunnel     release and evaluate for outcome regarding pain, VAS score, return to work time, CTS score     and complications at 6 months.   "
241241|NCT01018420|"     This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen     of 4.8 mg over 6 hours. In addition it will compare the electrocardiogram (ECG) changes, if     any, from this dosing regimen to that of a single dose of moxifloxacin 400 mg, a positive     control for the corrected QT interval (QTc) prolongation.   "
241170|NCT01017484|"     Understanding the possible mechanism(s) by which the DASH dietary pattern lowers blood     pressure will potentially enhance the value of this dietary intervention by elucidating the     conditions under which it will be most effective, identifying target populations, examining     its impact on vascular health beyond blood pressure, and enhancing the investigators'     understanding of the interactions among diet, blood pressure and vascular function. In     addition, results of this study may help to identify additional therapeutic targets.     Therefore, the overall goal of the proposed study is to determine the mechanism(s) by which     the DASH dietary pattern lowers blood pressure by using a controlled feeding design.   "
241171|NCT01017497|"     The purpose of this study is to estimate the rate of local control at the treated site of the     metastasis as a function of 1mm versus 3mm expansion about the gross tumor volume (GTV). Each     lesion, not each patient will be ranndomized to either the 1mm or 3mm margin with 40 lesions     randomized to each arm.   "
241172|NCT01017510|"     Conventional treatments include the use of steroids applied locally, or injection in to the     legion, or oral therapy.      Treatment is determined by the severity of the disease.      Injection in to the legion can be done in two methods        1. Subcutaneous injection syringe Lower        2. Using syringe DERMOJET - a syringe without a needle. So far there are no publications in          the medical literature of studies comparing efficacy, safety, convenience of use for          doctor-patient, of both methods.   "
241173|NCT01017523|"     Research has shown that diabetes affects both the patient and family, and that support from     family and partners helps diabetes patients manage their illness better. However, diabetes     programs rarely involve the partner. The purpose of this study is to test an intervention     that helps partners and patients who have type 2 diabetes better support each other. The     intervention will be delivered over the telephone to reach more people. Our hypothesis is     that an intervention that targets the couple has a greater effect on health and well-being of     patients than one that targets the individual patient alone.   "
241174|NCT01017536|"     This was a Phase II, randomized, double-blind, placebo-controlled trial conducted at 1 site     in South Africa. A total of 26 subjects were randomized 1:1 to receive 2 doses of either     AERAS-402 at 3 x 10^10 vp (N=13) or placebo (N=13) on Study Days 0 and 28. Dose-escalation to     a second group of 40 subjects was planned, but although no safety concerns were identified,     the sponsor decided not to continue the study.   "
241175|NCT01017549|"     The purpose of this multi-center clinical study is to compile post market performance and     safety data on the Axxent System.   "
241176|NCT01017562|"     In this study, the investigators utilized the 18F-fluoride PET method to evaluate THA cases     with a stable, septic or septic loosened implant in order to differentiate these clinical     settings using a novel uptake type classification approach.   "
241177|NCT01017575|"     The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined     with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically     infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is     safe, well tolerated, and efficacious   "
241179|NCT01017601|"     RATIONALE: A virus called Seneca Valley virus-001 (NTX-010) may be able to kill tumor cells     without damaging normal cells. It is not yet known whether NTX-010 is more effective than a     placebo in treating small cell lung cancer.      PURPOSE: This randomized phase II trial is studying NTX-010 to see how well it works compared     with a placebo when given after chemotherapy in treating patients with extensive-stage small     cell lung cancer.   "
241180|NCT01017614|"     The purpose of the trial is to demonstrate that intravenous iron oligosaccharide is     non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to     inflammatory bowel disease (IBD), evaluated as the ability to increase haemoglobin (Hb).   "
241181|NCT01017627|"     The investigators hypothesize that the post-hospitalized patient status is characterized by     subacute and reversible metabolic and hematological changes that, if addressed and treated in     a timely manner, would result in a reduced risk for repeat hospitalization. Consequently, a     structured quality improvement program, focused on increasing adherence to company wide     anemia management policies (ie hemoglobin monitoring within the first 3-5 days     post-hospitalization, followed by an appropriate EPO dose modification within the 7 days     post-hospitalization), will significantly decrease the risk of hospital re-admission in the     30 days after discharge.   "
241182|NCT01017640|"     This phase I trial studies the side effects and best dose of veliparib when given with or     without mitomycin C in treating patients with solid tumors that have spread to other places     in the body, cannot be removed by surgery or have come back. Veliparib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as mitomycin C, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving veliparib together with mitomycin C may kill more tumor cells.   "
241195|NCT01017822|"     RATIONALE: Monoclonal antibodies, such as conatumumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy     may uses high energy x-rays to kill tumor cells. Giving conatumumab together with gemcitabine     hydrochloride, capecitabine, and radiation therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of conatumumab when     given together with gemcitabine hydrochloride, capecitabine, and radiation therapy and to see     how well they work in treating patients with locally advanced pancreatic cancer.   "
241196|NCT01017835|"     The purpose of this study is to determine whether combined therapy with simvastatin and     hypotensive drugs (ACEI or ARB) may decrease the blood pressure. Moreover, we would like to     assess the influence of isolated hypertension on endothelial injury, and on the development     of atherosclerosis.   "
241183|NCT01017653|"     This is a phase II study of the combination of panitumumab with irinotecan in malignant     glioma patients. The primary objective of the study is to determine the activity of the     combination of panitumumab with irinotecan as measured by 6-month progression-free survival.     Secondary objectives include the following- to determine the safety of panitumumab in     combination with irinotecan in patients with malignant glioma; to determine the effect of     panitumumab in combination with irinotecan on corticosteroid dose for each patient; to     explore any relationship between epidermal growth factor receptor (EGF-R) mutational analysis     and efficacy or toxicity; and, to determine the response rate and overall survival of     recurrent glioblastoma (GBM) patients treated with panitumumab in combination with     irinotecan.      The patients will have histologically documented grade 4 malignant gliomas (glioblastoma     multiforme or gliosarcoma) that have failed at least one prior chemotherapy regimen and all     patients will have received radiation therapy. This study will investigate second or greater     line of therapy for recurrent grade 4 malignant glioma. The patient population will include     32 patients.      The patients will undergo a baseline magnetic resonance imaging (MRI) as well as a MRI after     every six-week cycle to determine response and progression. After 16 patients with recurrent     GBM are treated, an interim analysis will be conducted. The most common side effects     associated with panitumumab have been dermatological (skin) problems such as erythema     (redness of the skin), acneiform rash (skin eruptions of the face), skin exfoliation,     pruritus (itching), skin fissures (skin tears), xerosis (dryness of the eye, skin, or mouth),     and rash. The most common side effects associated with irinotecan have been decreased blood     counts of platelets (increased risk of bleeding), white blood cells (increased risk of     infection), red blood cells (anemia); diarrhea, constipation, nausea, vomiting, tiredness,     fever, mouth sores, dehydration (excessive loss of body fluids), rash, itching, changes in     skin color, swelling, numbness, tingling, dizziness, confusion, low blood pressure, sweating,     hot flashes, hair loss, inflammation of the liver, flu-like symptoms, decreased urine output,     shortness of breath, and pneumonia (inflammatory disease of the lungs).   "
241184|NCT01017666|"     The purpose of this study is to understand whether BIIB014 has potential to affect how     certain drugs are broken down by the body.   "
241185|NCT01017679|"     This is a multi-center phase II randomized controlled study to assess the efficacy of     Gefitinib 500mg in patients with IIIB/IV staged non-small cell lung cancer(NSCLC) with stable     disease after a month treatment of 250mg Gefitinib by DCR,also PFS and OS.The side effect is     evaluated as well.   "
241186|NCT01017692|"     The objective of this study is to establish a relationship between the degree of     radiologically established anatomical stenosis and the severity of self-assessed outcome     measures in patients that have undergone and MRI.   "
241187|NCT01017718|"     The investigators intend to study children and adolescents from 8 to 18 years suffering from     diabetes mellitus type 1 for more than one year. The patients will undergo a detailed     clinical examination for anthropometric data, blood pressure, blood and urine. Motor and     sensory nerve conduction velocity will be examined by electrical stimulation using surface     patch electrodes. The nerves to be examined are the nervus tibialis anterior, nervus medianus     and nervus peroneus.      Primary outcome:      How many children and adolescents suffering from diabetes mellitus type 1 (duration of     disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d) show pathological nerve     conduction velocity?      Secondary outcome:      Is there a significant difference in nerve conduction velocity between the group of diabetic     patients and the control group of healthy young people? Does the quality of disease control     have an influence on nerve conduction velocity? Is there a correlation between nerve     conduction velocity in our study patients and the Young Score? Is there a correlation between     pathological nerve conduction velocity and other long-term vascular complications     (nephropathy, retinopathy)?   "
241188|NCT01017731|"     The purpose of this study is to determine if Ramucirumab (IMC-1121B) causes prolongation of     the QT/QTc interval in participants with advanced cancer.   "
241234|NCT01018329|"     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging, may help doctors     predict a patient's response to treatment and help plan the best treatment. PURPOSE: This     clinical trial is studying magnetic resonance imaging in response to radiation therapy in     patients with high grade glioma.   "
241189|NCT01017744|"     Sevoflurane inhalational anesthetic has got pulmonary effects such as bronchodilatation.     These effects could be of interest in intensive care patients ventilated in pressure support     ventilation mode. The purpose of this study is to evaluate mechanical respiratory effects of     sevoflurane administered through a new specific heat and moister exchanger called the     Anesthetic Conserving Device (AnaConDa®) in pressure support ventilation in intensive care     patients. In fact, dead space and resistance generated by the device could cancel and even     deteriorate the potential positive effects of sevoflurane on ventilation.   "
241190|NCT01017757|"     Immunosuppressive drugs such as tacrolimus, cyclosporine, mycophenolate mofetil, sirolimus     and everolimus may have toxic pulmonary effects, particularly interstitial alterations. The     aim of the present study is to explore the presence of subclinical interstitial lung     abnormalities in stable renal transplant recipients taking the different immunosuppressive     drugs used as maintenance therapy for renal transplantation.   "
241191|NCT01017770|"     Several countries in Africa have changed their first-line treatment for uncomplicated malaria     to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and     Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local     effectiveness of these drugs when they are given to patients in real life conditions, without     direct observation of the drug administration. Thus, this study aims at investigating the     effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina     Faso.   "
241192|NCT01017783|"     The primary objectives of this clinical trial are to determine if replacing sugar sweetened     beverages with water consumption promote weight loss over 6 months in overweight adults and     if replacing sugar sweetened beverages with water consumption promote greater weight loss     over 6 months relative to replacement with other non-caloric sweetened beverages or control.      The secondary objective is to identify mediators and moderators of the effect of water     replacement including hydration status, glucose metabolism, anthropometrics, physical     activity, dietary intake and resting metabolic rate.   "
241193|NCT01017796|"     The use of N-acetylcysteine and ascorbic acid reduce the incidence of radiographic contrast     agent induced reduction in renal function in Intensive Care Unit patients.   "
241194|NCT01017809|"     The investigators propose to totally abolish the emesis (vomiting) associated with the     regimen of oxaliplatin + topotecan by adding a daily administration of aprepitant (Emend) for     17 days to the HT3 blocker routinely given on days 1 and 15.   "
241197|NCT01017848|"     Urine pH has been lately linked to insulin resistance. The early phase of Diabetes Mellitus     involves insulin resistance. Thus, the investigators want to check if a simple cheap study     like a urine analysis that can predict diabetes.   "
241228|NCT01018251|"     This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast     cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to     treatment. We will compare this technique with other imaging modalities as well as with     tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive     breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,   "
241198|NCT01017861|"     Recent studies have shown that women are more likely to experience pain in many medical     situations. During pregnancy, women may experience an increase in pain threshold. This is     thought to be related to hormonal changes and an increase in the level of certain natural     pain-relieving substances in their bodies.      It is important to develop simple tests to identify woman at higher risk for pain so the     investigators can help them.      Temporal summation is what happens when a person becomes more sensitive to a certain feeling     on their skin when it is applied several times over the course of several seconds. The     investigators hypothesize that pregnant women show decreased temporal summation and pain     scores to venipuncture, compared to non-pregnant women.   "
241199|NCT01017874|"     The purpose of this study is to compare two different approaches to treating non-small cell     lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will     receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib)     and the other half of the participants will receive only the oral anti-cancer agent     (gefitinib).   "
241200|NCT01017887|"     The new AirSeal access port for laparoscopic surgery does not use a mechanical valve on the     port to maintain gas in the peritoneal cavity. It uses an invisible barrier created by high     flow gas jets within the port. The percentage of carbon dioxide, the standard gas used for     laparoscopy, during laparoscopic surgery has not been previously measured, but is probably     high. The investigators aim to measure the percentage of intraperitoneal carbon dioxide with     standard ports and the AirSeal port during a variety of conditions during laparoscopic     procedures including suturing and suctioning. The study period will commence at the start of     the operation, and be completed upon discharge from the hospital or postoperative day 5,     whichever is shorter. All devices are approved for use in humans by the FDA, and are being     used for their intended purpose.   "
241201|NCT01017900|"     This study objectives are to compare the efficacy and safety between surgical excision and     manual rupture for dorsal carpal ganglion.The participants with dorsal carpal ganglion will     be randomized into 2 groups:surgical excision or manual rupture.The patients will be     follow-up for at least 1 yr.Telephone interview will be used for outcome assessment.   "
241202|NCT01017913|"     The purpose of this study was to compare the effects of the TENS and IFC in patients with non     specific chronic low back pain.   "
241203|NCT01017926|"     The purpose of this study is to compare the bioavailability of two oral formulations of     Triazolam in healthy volunteers, in order to determine that they are bioequivalent.   "
241204|NCT01017939|"     The purpose of this study is to evaluate the effects of multiple doses of abiraterone acetate     plus prednisone on the pharmacokinetics (study of what the body does to a drug) of single     doses of dextromethorphan hydrobromide and theophylline in patients with castration resistant     prostate cancer.   "
241205|NCT01017952|"     The Purpose of this study is to assess the efficacy and safety of three strengths of the     FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)   "
241235|NCT01018342|"     The objective of this study was to investigate the bioequivalence of Mylan nitrofurantoin     monohydrate/macrocrystals capsules to Procter & Gamble Macrobid® capsules following a single,     oral 100 mg (1 x 100 mg) dose under fed conditions.   "
241206|NCT01017965|"     The objective of this study is to assess the impact of objective sleep duration on blood     glucose control in type 1 diabetes adult patients.      This study will also evaluate the impact of objective sleep duration on blood pressure over a     24-hour period and the impact of objective sleep duration on quality of life.      Last, it will investigate the influence of objective physical activity duration on blood     glucose control, blood pressure and quality of life.   "
241207|NCT01017978|"     To determine if MRI imaging can be used to accurately determine if a sarcoma is responding to     the type of chemotherapy being used.   "
241208|NCT01017991|"     The purpose of the study is to assess if infants who have excessive crying and fussing have     less of these symptoms when fed a formula containing a probiotic compared to those fed a     standard infant formula.   "
241209|NCT01018004|"     RATIONALE: Gathering information over time from follow-up visits may help doctors plan the     best follow-up schedule. It is not yet known which follow-up schedule is more effective in     improving patient quality of life.      PURPOSE: This randomized clinical trial is comparing follow-up schedules to see how well they     work in patients with newly diagnosed stage IB or stage II melanoma.   "
241210|NCT01018017|"     Randomized, placebo-controlled, parallel-group, double-blind, multiple-dose, activity and     safety clinical study of SRT2104 administered orally once daily for 28 consecutive days. This     will be an inpatient/outpatient study to assess the safety and pharmacokinetics of SRT2104 in     type 2 diabetic male and female subjects on an existing, stable, background metformin     therapy. Approximately 80 subjects will be enrolled. Subjects will be evenly randomized to     receive SRT2104 2.0 g/day or placebo in the fed state.      Subjects will be required to stay overnight at the study center on Days -2, -1, 0, 1     (optional discharge at investigator's discretion), 27, 28, 41, and 42. During these     admissions, pharmacokinetic, biomarker and glycated albumin samples will be collected, and     glucose profiling, OGTT, glucose stabilization, hyperinsulinemc euglycemic clamp (HEGC)     studies with indirect calorimetry and various other safety and activity procedures will be     performed. On Day 1 of the study, subjects will be randomized to receive SRT2104 or placebo.     Day 43 will be the last day of the study and subjects will be released. In addition, subjects     will be asked to return to the study center on Day 14 for interim safety assessments.      During the dosing period, study personnel will contact subjects by telephone on Days 7 and 21     to conduct a safety assessment. Subjects will be required to monitor their fasting blood     glucose and complete a daily diary for the outpatient portion of the study between Days 1 and     28. A follow-up, safety phone call will occur 30 days following their final dose of SRT2104     or placebo (Day 58 of the study) to identify any possible additional adverse events or     concomitant medications.   "
241211|NCT01018030|"     The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal     spray (FFNS), without the use of an antibiotic, in the treatment of adult and adolescent     subjects who are 12 years of age and older with uncomplicated acute rhinosinusitis (ARS).   "
241212|NCT01018043|"     The purpose of this study is to create a large Thailand database documenting the severity of     anemia and its management in the cancer population.   "
241227|NCT01018238|"     This trial is conducted in the United States of America (USA). The aim of this clinical trial     is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of     increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus     (SLE).   "
241213|NCT01018056|"     A joint NIH -Tourette Syndrome Association Conference has emphasized the critical need for     the testing and development of new pharmacotherapy for tic suppression in Tourette syndrome     (TS). This submission is a safety, tolerability and efficacy pilot study using two     medications that modulate glutamate neurotransmission, riluzole, a glutamate antagonist, and     D-serine, a glutamate agonist. Glutamate is the primary excitatory neurotransmitter in the     central nervous system, an essential component of pathways implicated in TS and an extensive     modulator of dopamine, the major neurotransmitter associated with tics.      This is a single site, short-term, proof of concept study of riluzole and D-serine for the     treatment of tics. Each medication will be evaluated and compared to placebo as part of a     double-blind, randomized, parallel, flexible dose, three-arm, 8-week, treatment protocol     (D-serine, riluzole, or placebo). A total of sixty patients (age 8-17 years) with TS and     moderate to moderately-severe tics will receive study medication according to a 2:1 (dopamine     modulating drug: placebo), randomized schedule, i.e., riluzole (n=24), D-serine (n=24),     placebo (n=12). The primary outcome measure is tic suppression as determined by changes in     the Total Tic Subscore of the Yale Global Tic Severity Scale (YGTSS). Secondary tic outcome     measures include changes in the YGTSS Total Score and two Global Impression Scales. Further,     since both riluzole and D-serine have been proposed as treatments for obsessive-compulsive     behaviors, a TS co-morbidity, these symptoms will be followed. Safety measures include serial     physical examinations, vital signs, laboratory studies (comprehensive metabolic panel,     complete blood count, plasma amino acids, and urine analyses), documentation of side effects     and adverse events, and measurement of changes in ADHD, depression and anxiety.      This pilot investigation will provide important proof-of-concept data on glutamate therapies     for TS and, in turn, evidence for large-scale, multi-center clinical trials.   "
241214|NCT01018069|"     To determine if AEG35156 can enhance the combined complete remission (CR) and CR with     incomplete platelet recovery (CRp) rate of high-dose cytarabine and idarubicin in AML     following failure of a single standard dose cytarabine based frontline induction regimen.   "
241215|NCT01018082|"     The overall goal of this 2-year pilot project is to utilize interdisciplinary strategies to     determine the prevalence and type of neurodevelopmental impairment in PHACE syndrome, a rare     vascular syndrome, and to rapidly translate discovery into clinical care guidelines that will     identify at risk infants so early intervention can be initiated. Infantile hemangioma is the     most common benign tumor of infancy, with an incidence estimated between 4-5%. A subgroup of     patients with infantile hemangiomas exhibits additional associated structural anomalies of     the brain, cerebral vasculature, eyes, aorta, heart, and chest wall in the rare     neurocutaneous disorder called PHACE syndrome (OMIM 606519). PHACE refers to Posterior fossa     anomalies, Hemangioma, Arterial lesions, Cardiac abnormalities/aortic coarctation, and     abnormalities of the Eye. Affected children have multi-organ involvement, and an increasing     number of cerebral, cerebellar, and cerebrovascular anomalies are being described; however,     the significance of these neuroradiologic findings is not known. As the investigators'     neonates with hemangiomas have grown into young children, neurodevelopmental impairment has     become more evident, even among patients without MRI evidence of stroke or structural brain     anomalies. Some infants develop progressive cerebral arterial disease leading to a     moyamoya-like vasculopathy and ischemic stroke. An interdisciplinary research project     studying brain and cerebral vascular imaging in concert with neurological, psychological,     behavioral, neurodevelopmental, and quality of life outcome measures has never been     conducted. Diagnostic and management guidelines are also lacking. The investigators'     long-term goal is to develop medical and/or surgical therapeutic interventions that improve     the overall health of children with PHACE syndrome. This novel project constitutes the first     study of the most devastating feature of PHACE syndrome: the neurodevelopmental sequelae.   "
241216|NCT01018095|"     The purpose of this study is to determine if the 2 gram single dose of metronidazole is as     effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among     HIV-infected women.   "
241218|NCT01018121|"     The objective of this project is to pilot test a behavioral intervention for modifying the     diet and physical activity patterns of overweight preschool children through improved     parenting and nutritional education(LAUNCH). This intervention will be compared to standard     of care for preschool overweight in the primary care setting using a randomized clinical     trial design (RCT. The results of this pilot RCT will provide data integral to estimating the     effect size for a more definitive RCT of the intervention in the future. The primary     hypothesis is:      H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the     standard of care at 12 months post-treatment.   "
241219|NCT01018134|"     The objectives of this study are to evaluate the efficacy and safety of two dosing regimens     of desoximetasone 0.05% and 0.25% topical sprays as compared to a vehicle spray in patients     with moderate to severe plaque psoriasis.   "
241220|NCT01018147|"     This clinical trial studies 4-dimensional (4-D) image-guided radiation therapy treatment     planning in patients with stage I-IV non-small cell lung cancer. Computed tomography (CT)     scans and treatment-planning systems may help in planning radiation therapy for patients with     non-small cell lung cancer. This is not a therapy study. Therefore no direct benefit from     participating is expected. However, at the discretion of the treating physician, the     information gained from the additional imaging will be used to improve treatment accuracy. No     patient outcome data are gathered or analyzed by this study. This study is not a:Phase I, II,     or III trial, trial with blinded treatment arm, gene or a vaccine trial, or a     multi-institutional trial.   "
241221|NCT01018160|"     The purpose of this study is to examine the treatment profile of approximately 1,000 adult     patients with gastroesophageal reflux who begin raberpazole sodium treatment for 4 months,     and assess patients' adherence to the study drug.   "
241222|NCT01018173|"     This randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and     safety and the effects of taspoglutide on cardiovascular events in patients with inadequately     controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be     randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks     followed by 20mg sc weekly, or weekly sc placebo, in addition to background     anti-hyperglycemic medication and standard of care treatment for cardiovascular disease.     Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients.   "
241223|NCT01018186|"     The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444   "
241224|NCT01018199|"     In this study the investigators aim to test if C-reactive protein (CRP) or procalcitonin(PCT)     - guided strategy allows to reduce the antibiotic use in patients wiht community-acquired     pneumonia. Therefore, the safety of this intervention will be carefully measured.   "
241225|NCT01018212|"     The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort)     usage in the treatment of cutaneous grooves. The duration of this phase 2 clinical trial will     be 4 months.   "
241226|NCT01018225|"     The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of     moderate to severe nocturia in patients with overactive bladder and who do not have     non-urologic causes of nocturia.   "
241231|NCT01018290|"     Maximizing surgical removal of brain tumors while minimizing neurologic deficits is     challenging. Functional brain tissue may reside close to or even within the abnormality, and     inadvertent removal or disturbance of such areas can result in neurologic deficits. At     present, the gold standard for identifying critical motor areas in tumor surgery is     intraoperative invasive direct current stimulation (DCS) through a handpiece. More recently,     new non-invasive preoperative method for brain mapping, functional magnetic resonance imaging     (fMRI), may be used to identify the eloquent motor areas. fMRI signals used in localization     of the motor areas are generated when the brain is activated during the performance of     specific motor tasks. However, as fMRI signals are also generated by sensory input, the     resulting fMRI map may include sensory as well as motor areas.      Nexstim has developed a Navigated Brain Stimulation (NBS) system that uses TMS with a     software based Navigational System that together may have more specific spatial accuracy.      This study aims to determine whether navigated TMS is able to identify the eloquent motor     cortical areas in patients with brain tumors and to determine the clinical accuracy of the     procedure by comparing it to results obtained by intraoperative DCS and fMRI.   "
241232|NCT01018303|"     The purpose of this study is to test the safety and efficacy of the final commercial     formulation of an antioxidant enriched multivitamin supplement in softgel capsule form     (AquADEKs) in increasing the plasma levels of certain nutrients and antioxidants in     individuals with cystic fibrosis.      Hypothesis: An oral antioxidant-rich multivitamin supplement (AquADEKs), which uses a     Generally Regarded As Safe (GRAS) molecule to form micelle-like vehicles, will safely     increase systemic levels of beta-carotene, coenzyme Q10, and gamma-tocopherol, decrease     PIVKA-II levels, while maintaining levels of vitamins A and D in the normal range in persons     with CF > 10 years of age.   "
241233|NCT01018316|"     The UMOX is a device that has been designed as an alternative to the conventional face mask     for preoxygenation to be used when an optimal preoxygenation with a facemask is difficult to     achieve(i.e: when a leak is present. A previous study in our hospital (unpublished data) has     shown that the UMOX was only as effective as the conventional mask when a nose clip was used     to prevent the patients from breathing in some air through the nose, thus preventing the     dilution/contamination of the 100% oxygen delivered.In that study, the verbal indication     giving to the subjects to breathe through the mouth was better than no indication at all but     still yielded unsatisfactory results.      For this reason, the present study was designed to verify the hypothesis that while using the     UMOX for preoxygenation, the verbal indication of breathing 8 vital capacity breaths added to     the indication of breathing through the mouth would bring equivalent results -measured by the     expired fraction of oxygen- as a preoxygenation of normal tidal breathing through a facemask     during 3 to 5 minutes.      Preoxygenation was performed with the 60 volunteers placed in the supine position with 100%     oxygen. All volunteers went though preoxygenation with two techniques: 1) breathing normal     tidal volumes at a normal respiratory rate for a period of 5 minutes through a tight fitting     conventional face mask, and 2) eight deep breaths (i.e. vital capacity breaths) through the     UMOX device with verbal indication to use only the mouth to breathe.   "
241290|NCT01019070|"     The purpose of this study is to assess the effects of hepatic impairment on the multiple dose     pharmacokinetics of BMS-650032.   "
241236|NCT01018355|"     The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet     medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA)     when compared to antiplatelet medical management alone in elderly patients above 50 years of     age with a PFO and a history of cryptogenic stroke or TIA.   "
241237|NCT01018368|"     The objectives of this study are to evaluate the effects of multiple doses of rifampin on the     single-dose pharmacokinetics of VX 770.   "
241238|NCT01018381|"     Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide with an estimated     626,000 new cases per year worldwide, accounting for 5.7% of new cancer cases. Although     resection and transplantation offer the best 5-year survival rates, not all patients are     suitable surgery candidates. Other treatments include pericutaneous ethanol injection (PEI),     radiofrequency ablation (RFA), and transarterial oily chemoembolization (TOCE), all of which     enhance the survival rate and aid in shrinkage of the tumor. The very low survival rate among     HCC patients, 3-5%, reflects the inadequacy of conventional therapies for the disease and     highlights the necessity of finding new treatments or modifying the current treatment.      The hepatitis B virus (HBV) causes liver disease that can range in severity from a mild     illness that lasts several weeks (acute hepatitis B) to a long-term chronic illness. An     estimated 2 billion people have been infected with HBV worldwide, resulting in more than 350     million individuals with chronic, long-term liver infections. Patients with chronic HBV     infection are at a great risk for the development of cirrhosis, hepatic failure, and HCC.     There is no cure for hepatitis B and care is mostly palliative. There are several anti-viral     and interferon drugs, such as Entecavir and Interferon α therapy, which can help some     patients. However, these drugs are costly, thousands of dollars per year, and are not widely     available in many countries, especially in the developing world. Vaccination is available and     effective and is recommended for all individuals at risk for HBV infection. However,     vaccination is only effective in individuals who have not been exposed to HBV. Hepatitis B is     closely linked to liver cancer, which is almost always fatal.      MGN-3/Biobran is an arabinoxylan extracted from rice bran that is treated enzymatically with     an extract from Shiitake mushrooms. MGN-3 demonstrated anti-cancer activity in vivo in mice     and humans. The present study was carried out to examine whether combining the current     conventional treatment with a food supplement, arabinoxylan rice bran (MGN-3/Biobran), may     improve the outcome of the disease and increase the survival rate of patients with HCC or     HBV. We hypothesize that a combinatory treatment of conventional therapy with MGN-3/Biobran     will augment the therapeutic effect seen when patients are treated with conventional therapy     alone.   "
241239|NCT01018394|"     Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the     risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking     reduction increases smoking abstinence among smokers not interested in quitting. The     overarching goal of this line of research is to develop a ST reduction intervention among ST     users not interested in quitting tobacco. Our first step is to conduct the proposed pilot     study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for     reducing ST use or facilitating ST abstinence among ST users not interested in quitting.   "
241240|NCT01018407|"     The goal of this project is to compare the efficacy of two interventions for improving spoken     language and reducing symptoms of autism.   "
241242|NCT01018433|"     The purpose of this study is to investigate an intervention specifically for non-suicidal     self-injury (NSSI) in young adults. The goal of this 9-session outpatient intervention is to     reduce the frequency and severity of NSSI. During Phase I, 12 patients will be treated in an     open pilot trial. During Phase II, 60 patients will be treated in a randomized controlled     pilot study in order to determine the feasibility and acceptability of the intervention and     to investigate change in NSSI frequency and severity over time.   "
241243|NCT01018446|"     In this study the investigators plan to develop a method to determine optimal busulfan dose     through pharmacokinetic study.   "
241244|NCT01018459|"     The purpose of this study is to evaluate the safety of a malaria vaccine, Ad35.CS.01, and how     the body reacts to vaccination. Participants will include 48 Berkinabè healthy males and     females ages 18-45 years in Burkina Faso. Volunteers for this study will be divided into 4     groups. Members of each group (12 per group) will receive an increasing dose of vaccine or     placebo (an inactive substance). Ten will receive the malaria vaccine and 2 will receive     placebo. Study procedures include: physical exam, urine sample, and blood samples.     Participants will be involved in study related procedures for about 13 months.   "
241245|NCT01018472|"     Infants with congenital heart disease have more frequent infections and exposures to     antibiotics than healthy infants. It is unknown how congenital heart disease affects the     development of bacterial colonization of the intestines. It is also unknown whether     probiotics will change the bacteria in the intestine of infants with heart disease to become     more like those of healthy infants without heart disease. This pilot trial is designed to     address these two questions.   "
241246|NCT01018485|"     The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds     of patients. Over half of the tremors involve the upper limb and frequently lead to further     disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine,     clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and     tetrahydrocannabinol have been reported to have some beneficial effect but published evidence     of effectiveness is very limited. The investigators' experience to date suggests that many of     the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy.      Aims:      1. The investigators aim to determine the efficacy of commonly used doses of BOTOX on the     patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects     associated with this treatment.   "
241247|NCT01018498|"     Malabsorption of certain foods (e.g. lactose) has been proposed as a cause of irritable bowel     syndrome in adults and children. Recently, a diet that lowers intake of a combination of     foods has been found to be effective in adults with IBS identified with fructose     malabsorption.      The purpose of this study is to determine whether a restricted fermentable substrate diet is     effective in the treatment of irritable bowel syndrome in children.   "
241248|NCT01018511|"     Clinical study to examine the efficacy, safety and tolerability of combination therapy of     tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin     hydrochloride in the treatment of males with LUTS associated with BPH with a substantial     storage component.   "
241249|NCT01018524|"     The purpose of this study is to:        1. compare the long term results of mesh versus suture repair in treatment of abdominal          wall defects;        2. find the optimal location of implanted prosthesis, comparing the two most useful          position of mesh in abdominal wall hernia surgery.   "
241261|NCT01018680|"     The study will test the hypothesis that, in patients with knee pain due to osteoarthritis     (OA) who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) but still have significant     knee pain, duloxetine 60 to 120 milligrams (mg) daily for 10 weeks will provide additional     reduction in pain.   "
241250|NCT01018537|"     This project is based on the idea that we can learn about the complexities of MS by following     disease and treatment patterns in a large group of people over several years. The information     gathered is used for research only. Results are presented in summary form only. All details     submitted by registry participants is strictly confidential.      To participate in NARCOMS complete the baseline enrollment survey online at www.narcoms.org     or you can request a mail-in survey be sent to you using the contact information provided.     You will be asked to update the survey, online or by mail, twice a year. Each survey     typically takes less than 20 minutes to complete. Surveys are available in English and     Spanish.      There is no cost to participate, for your participation you are offered a free subscription     to the NARCOMS Quarterly Magazine. A quarterly magazine delivered to all NARCOMS participants     provides a reliable source of information about the latest in MS research and disease     management. You can quit participating at any time.      You may also receive additional surveys or information on clinical trials. You are not     obligated to participate and these additional studies will always come directly from NARCOMS.     Your contact information will not be shared or sold to other parties.   "
241251|NCT01018550|"     The primary objective is to determine if AMG 853 is effective compared with placebo as     measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from     baseline to week 12.   "
241252|NCT01018563|"     An open label extension of the MORAb-003-002 study in order to continue the active patients     in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.   "
241253|NCT01018576|"     Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of     premature infants. However this procedure is not standard due to concerns that the premature     infant will get too cold. In this study the investigators look at using a plastic covering     and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to     clamp the umbilical cord.   "
241254|NCT01018589|"     The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort)     usage in the treatment of epidermic burns or post surgical scars. The duration of this phase     2 clinical trial will be two months.   "
241272|NCT01018823|"     Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2     Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability,     pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.   "
241273|NCT01018836|"     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs, such as     riluzole, may make tumor cells more sensitive to radiation therapy. Giving riluzole together     with whole-brain radiation therapy may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of riluzole when given     together with whole-brain radiation therapy in treating patients with brain metastases.   "
241255|NCT01018602|"     The aim of the study is to prove the efficacy of the oral intake of vildagliptin in a daily     dose of 100 mg in scope of the development of type 2 diabetes in women with insulin dependent     gestational diabetes in their last pregnancy not longer than 9 months after birth.      In this randomized, placebo-controlled, double-blinded clinical phase II study, 140     participants aged 18 years or older and an insulin dependent gestational diabetes in their     last pregnancy should be included and treated with vildagliptin or placebo over 24 months,     followed by a 12 months observation period. Exclusion criteria are pregnancy and lactation as     well as a clinical overt diabetes or islet autoimmunity.      The null hypothesis is that there is no significant difference of diabetes incidence     (according to ADA criteria 1997) in both groups.      Primary endpoint is the clinical manifestation of diabetes, secondary endpoints include the     improvement of beta cell function (evaluable by C-peptide measurement) and of insulin     sensitivity by the treatment with vildagliptin.   "
241256|NCT01018615|"     The purpose of this study is to determine if the safety, metabolism, and antioxidant activity     of silymarin and green tea extract are changed when they are given in combination to patients     with chronic hepatitis C infection.   "
241257|NCT01018628|"     The main purpose of this study is to assess the safety and pharmacokinetics of SRT2379 (25,     75, 250, 500, 1000, 2000, and 3000 mg/day [fasted] and 500 mg/day [fed]) in healthy male     volunteers.      The purpose is also to explore the effect of SRT2379 on plasma concentrations of Fibroblast     Growth Factor 21 (FGF21) and to identify other possible biomarkers suitable for future     clinical assessment of oral SIRT1 activators.   "
241258|NCT01018641|"     This study is a first-in-human (Phase 1) study using three dose levels of an investigational     vaccine directed against Staphylococcus aureus (SA3Ag). This study is primarily designed to     assess how safe and well tolerated SA3Ag is, but will also describe the immune response over     12 months elicited by SA3Ag. Additionally, this study will assess the effect of SA3Ag vaccine     on the number of Staphylococcus aureus bacteria that naturally occur on the skin and within     the nose and throat.   "
241259|NCT01018654|"     The purpose of this study is to compare a culturally adapted and a non-culturally adapted     group-based substance abuse treatment with Latino adolescents.   "
241260|NCT01018667|"     The ADOPT study is a prospective, nested case-controlled and open label clinical trial. About     40 centers across China participate in this study with a planned 800 Chinese cases     enrollment. All patients will receive optimal medical treatment. Patients who have successful     CRT-P/D implant will be assigned to CRT group. According to the baseline evaluation, matched     cases will be selected from the enrolled OPT(optimal medical treatment) alone group (Group     for Selection). After successful match, the cases in Group for Selection enters into     follow-up and become control group. The unmatched cases in the Group for Selection will be     removed. If patients agree, after re-evaluation of the baseline situation, she or he may     enter into Group for Selection again. Since patients know she/he already have a device     implant and the examiners are aware of the grouping of the patients after seeing the incision     scar and post-implant electrocardiogram, this study is open-label designed, however the     executive committee will be kept blind when making event-adjudication. Prospectively defined     primary end points for the study include combined all-cause mortality and hospitalizations. A     variety of secondary end points will further define the efficacy and mechanism(s) of action     of cardiac resynchronization in heart failure. The last date of the study shall be the day     after 24 months of follow-up of the last enrolled patient. All cases collection complete in     2010 and study result will be reported in 2012.   "
241263|NCT01018706|"     The purpose of this study is to confirm or confute the hypothesis that in patients treated     with primary pci is not always possible to collect an adequate medical history, the     investigators created a clinical registry in which the investigators collect current or     previous medical history relevant to DES utilization , in two distinct times.   "
241264|NCT01018719|"     The current study is aimed to evaluate various imaging methods, including multidetector     computed tomography (MDCT) as potential surrogates to assess the degree of damage caused to     the heart by radiation therapy to the breast, in breast cancer survivors many years before it     becomes clinically apparent.   "
241265|NCT01018732|"     The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent     subjects who completed study V59P6 in which they received either Novartis Meningococcal     (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The     study will also enroll age-matched subjects who have never received any other meningococcal     vaccine (naïve subjects) to serve as an additional control group.   "
241266|NCT01018745|"     The purpose of this clinical study is to establish the maximum tolerated dose (MTD) and     recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when     administered orally on a once daily schedule in subjects with advanced or metastatic solid     tumors.   "
241267|NCT01018758|"     This is an open-label, multicenter phase II study in patients with aggressive Non Hodgkin     Lymphoma scheduled to receive moderately emetogenic polychemotherapy (according to modified     Hesketh classification for antiemetic therapy).   "
241268|NCT01018771|"     This is a prospective randomised study.      Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone     fusion.      Secondary objectives: Assess clinical outcome measurements.   "
241269|NCT01018784|"     MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks     as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated     dose.   "
241270|NCT01018797|"     To evaluate the clinical outcomes of Intrastromal Corneal Ring Segment (ICRS) implantation to     correct high-degree astigmatism on eyes with prior penetrating keratoplasty (PK).   "
241271|NCT01018810|"     In this study, we will evaluate clinical activity, safety, tolerability, pharmacokinetics,     pharmacodynamics, and immunogenicity of 5 LY2525623 dosing groups compared to placebo in     adults with plaque psoriasis.   "
241274|NCT01018849|"     The purpose of this study is to determine if Vitamin D supplementation helps prevent     recurrent cardiovascular events, such as heart attack or stroke, in patients who have already     experienced at least one cardiovascular event. This study will investigate if the addition of     150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a     subject's medication regimen will prevent further cardiovascular events.   "
241275|NCT01018862|"     The purpose of this study is to compare the effectiveness of an Investigational use of an     allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a     nasal spray that contains no medicine). In addition, the study will also compare the safety     and effectiveness of an investigational use of another allergy medication (MP03-36) used to     treat perennial allergic rhinitis to placebo.   "
241276|NCT01018875|"     Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.   "
241277|NCT01018888|"     The purpose of this study is to evaluate the stability of artificial cornea manufactured by     Aurolab and to assess its visual outcomes.   "
241278|NCT01018901|"     RATIONALE: Gathering information about survivors of prostate cancer and their partners may     help doctors learn more about the goals for sexual functioning after cancer treatment.     PURPOSE: This clinical trial is studying the goals of sexual functioning in prostate cancer     survivors and their partners after cancer treatment.   "
241279|NCT01018914|"     To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release     tacrolimus with Myfortic® in de novo liver transplant recipients.   "
241280|NCT01018927|"     The purpose of this study is to see if MRI techniques can be used for early evaluation of     cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma. Cardiac     amyloidosis is a medical disorder that decreases heart function.   "
241281|NCT01018940|"     To determine if prasugrel is superior to clopidogrel in providing adequate antiplatelet     effect in a high risk population that requires concomitant use of a Proton Pump Inhibitor     (PPI).   "
241282|NCT01018953|"     The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's     overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with     carcinoid syndrome after 24 weeks of treatment.   "
241283|NCT01018966|"     The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of     ixabepilone in Japanese patients with solid tumors.   "
241284|NCT01018979|"     A phase II study to evaluate the safety, pharmacokinetics, and hematopoietic stem cell     mobilization of TG-0054 in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin     disease.   "
241285|NCT01018992|"     This study will test the hypothesis of whether an antagonist at the corticotropin releasing     factor type 1 (CRF1) receptor (i.e. GSK561679) is superior to placebo in reducing symptoms of     post-traumatic stress disorder (PTSD).   "
241286|NCT01019005|"     The aim to test whether continues local anaesthetic infusion via tibial catheter or wound     catheter will improve pain relief following forefoot surgery      In this sequential prospective randomised, controlled clinical trial,75 Patients undergoing     forefoot surgery will be randomized into three groups (tibial, wound, control). All groups     will receive ankle block ± general anesthetic (standard technique). The tibial group will     have a tibial catheter inserted through which local anaesthetic will be infused. The wound     group will have a catheter inserted directly into the wound immediately after surgery. The     control group will have a sham catheter (covered by a bandage across foot) attached to a pump     which will not infuse. Patient maximum pain scores (primary outcome measure), nausea/     vomiting, analgesia use, satisfaction and sleep disturbance will be recorded postoperatively.     All groups will be then followed by telephone calls 48 hours. Patients will be instructed to     come to the clinic on the 4th postoperative day where the catheter will be removed.   "
241287|NCT01019018|"     The purpose of this study is to compare the efficacy of olive tip cannula to the standard     Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract     surgery.   "
241291|NCT01019083|"     The efficacy and immunogenicity of enteric vaccines have generally been found to be lower in     children in the developed than in the developing countries. This has been observed with     vaccines against cholera rotavirus, ETEC and typhoid vaccines. There are a number of factors     that may contribute to such differences in vaccine take rates in children, e.g. breast     feeding and nutritional status of the children might influence their immunogenicity and     efficacy. Thus, breast feeding of newborn and young infants may adversely influence the     immune response to vaccination, which might have more pronounced effect in developing than in     developed countries. Breastfeeding has also been shown to interfere with the serum immune     responses to rotavirus vaccine although this effect could be overcome by administering three     rather than one dose of the oral rotavirus vaccine. Our recent study of Dukoral in     Bangladeshi children aged 18 months or younger has shown that the response rates and the     magnitude of responses improved when breast milk was temporarily withheld . Thus,     administration of vaccines may have to be adjusted when given to breast fed children. Another     factor that may affect the immunogenicity is the effect of zinc. Previous studies have shown     that zinc enhances the immune response to cholera vaccine in participants > 2 years of age ,     a recent study also observed a similar effect in infants.      In this research project, we plan to study a number of different factors that might influence     the immunogenicity of the two licensed oral model vaccines, specifically the inactivated     killed oral cholera vaccine, Dukoral, and the live oral typhoid vaccine, Ty21a. We will also     identify strategies that might improve the immunogenicity of the vaccines. The main objective     of our study is to identify immunization regimens that may improve the immunogenicity of the     vaccines in young children, which could be subsequently in field trials in Bangladesh and     other developing countries. Specifically, we will determine if: (i) interventions identified     to enhance immune responses to Dukoral, including zinc supplementation, could also enhance     the immune responses to Ty21a; (ii) these two vaccines are able to induce both acute and     memory B and T cell responses, (iii) treatment with antiparasitic drugs prior to immunization     could modulate the immune responses to cholera and typhoid vaccines; and (iv) examine if     arsenic exerts a suppressive effect on the immunogenicity of these vaccines.   "
241292|NCT01019096|"     The three specific aims of this study are 1) to assess the impact of iron status on relative     differences in absorption of heme and non-heme iron among pregnant women and non-pregnant     women, 2) to assess the magnitude and the determinants of heme and non-heme iron transfer to     the fetus over the last trimester of pregnancy, and 3) to characterize relationships between     placental iron binding proteins with the enrichment of stable iron isotopes in the neonate at     birth. The investigators hypothesize that there will be up regulation of heme and non-heme     iron absorption and up regulation of placental iron transport proteins in response to low     maternal iron stores.   "
241293|NCT01019109|"     The purpose of this study is to find out the outcomes of using the PASS LP System to correct     idiopathic scoliosis. This system is a unique set of spinal instrumentation used to     surgically correct the rotation and deformity of the spine that is caused by scoliosis. Also,     this study wants to find out the effects this system has on the physical appearance and     quality of life for patients with scoliosis.   "
241294|NCT01019122|"     In 2003, observational growth and bone density data was obtained on children with cerebral     palsy (CP) living at Hattie Larlham as part of a study comparing growth with an existing     database of children with CP who live at home. The original residents included in that study     are now of adult age. Due to the lack of longitudinal bone density measurements in     facility-based adults with severe CP, the investigators' objective is to obtain 6-year     follow-up data from the residents enrolled in the original study.   "
241295|NCT01019135|"     The purpose of this study is to compare women's cardiac rehabilitation program adherence     across three program models.   "
241296|NCT01019148|"     Recessive dystrophic epidermolysis bullosa (RDEB) is a disease caused by genetic mutations in     the gene for type VII collagen. Patients with RDEB develop large, severely painful blisters     and open wounds from minor trauma to their skin. We are screening subjects with RDEB to     evaluate characteristics of the subjects and their cells in order to develop new strategies     of therapy and determine whether subjects could be candidates for treatment studies.   "
241297|NCT01019161|"     The purpose of the study is to assess how AZD1152 is absorbed or excreted in and out of the     body in patients with Acute Myeloid Leukaemia (AML).   "
241298|NCT01019174|"     The purpose of this study is to investigate the efficacy and tolerability of LEN/low-dose DEX     and continuous low-dose CY administered orally compared to LEN in combination with low-dose     DEX and single CY doses IV in patients with relapsed MM.   "
241299|NCT01019187|"     RATIONALE: Sleep disorder counseling may reduce fatigue and insomnia as well as improve the     well-being and quality of life of cancer survivors. Armodafinil may help relieve insomnia and     fatigue in patients with cancer after chemotherapy. PURPOSE: This randomized phase II trial     is studying how well cognitive behavioral therapy with or without armodafinil works in     treating cancer survivors with insomnia and fatigue after chemotherapy.   "
241300|NCT01019200|"     Psoriasis patients are known to be at increased risk for heart disease. This may be due to     the increased prevalence of cardiovascular disease risk factors in this population, including     high blood pressure, diabetes, obesity, and high cholesterol. Although cholesterol levels are     known to be altered in psoriasis, most studies have used standard lipid profiles to measure     cholesterol. These tests indirectly measure LDL (bad cholesterol) and become less accurate     when triglyceride levels are high, as often see in individuals with psoriasis. We have     designed a case-control study that uses a more specific and detailed cholesterol test to     measure serum lipid levels in psoriasis patients, allowing for more accurate determination of     LDL and better assessment of the lipid-contribution to cardiovascular risk. We will also     measure other markers of inflammation that may contribute to cardiovascular disease.   "
241301|NCT01019213|"     Conventional right ventricular (RV) apical pacing may result in asynchronous ventricular     contraction with delayed left ventricular activation, interventricular motion abnormalities,     and worsening of left ventricular ejection fraction. His pacing is preserving a synchronous     contraction and may prevent a decrease in left ventricular ejection fraction.      Hypothesis: His-pacing preserves left ventricular function and is a feasable alternative     compared to RV septal septal pacing in patients with AV-block.   "
241302|NCT01019226|"     Trial of new work in progress (WIP) sequences in MRI.   "
241312|NCT01019369|"     Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for     many women. However, difficulty in access may cause many women to discontinue use, often     without the use of another effective method of contraception, thereby leaving them vulnerable     to unintended pregnancy. This study will randomly assign women who present for contraceptive     services to two groups: self or clinic administered SC DMPA. The participants will be     followed for one year to compare continuation rates, acceptability, cost effectiveness,     evidence of skin changes, and need for continued support between the two groups.   "
241413|NCT01011244|"     Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is     high. On 15 October 2008, orphan designation was granted by Korea FDA for human     adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study,     patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to     evaluate the safety and efficacy.   "
241303|NCT01019239|"     The aim of the study is to compare patient outcome following standard of care (Hartmann's or     resection with anastomosis and defunctioning stoma) and a 'new therapy' (laparoscopic lavage     alone) for the treatment of acute perforated non-faeculant diverticulitis in Irish hospitals.      Perforated diverticulitis requires emergency surgery. This carries significant risks and     mortality as high as 15% during the index admission has been reported. Our group has     established the safety of laparoscopic lavage alone on the largest cohort to date in a     prospective multi-institutional study of 100 patients, providing convincing evidence that     laparoscopic lavage alone is a reasonable alternative to resection for non-faeculant     perforated diverticulitis. Our aim now is to translate this well-established study design     into a protocol for a multi-institutional randomised control trial as direct comparison is     the only way to provide convincing evidence of one modality over another.      All patients will be followed up for twelve months and primary (operative and in-hospital     mortality) and secondary (in-hospital and post-discharge morbidity; rates of stoma formation;     rates of re-presentation with diverticulitis with or without perforation.) end-points will be     recorded.      Sample size calculations reveal that a patient cohort of 100 in each arm will be sufficient     to detect a difference in morbidity and mortality between groups The ratio between Hinchey 3     and Hinchey 4 is estimated to be approximately 2:1. In order to guarantee sufficient sample     size, therefore, 300 patients must fulfil the study criteria allowing for exclusion of 100 at     time of operation   "
241304|NCT01019252|"     The proposed study will be an initial test of a cognitive-behavioral intervention for     adolescents with ADHD who are receiving medication treatment. It is based on our successful     work with adults with ADHD who have been treated with medicines but are still having     symptoms. It involves learning skills for organization and planning, attention, and mood.   "
241305|NCT01019265|"     This trial was designed for comparison and evaluation of the efficacy and safety of     buprenorphine transdermal patch (Norspan® patch 5 mg, 10 mg and 20mg) against oral tramadol     (Tridol® SR (slow release) tablet 100mg) in patients with moderate to severe pain due to     osteoarthritis.   "
241306|NCT01019278|"     RATIONALE: Specialized radiation therapy, such as proton beam radiotherapy, that delivers a     high dose of radiation directly to the tumor may kill more tumor cells and cause less damage     to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving radiation therapy with chemotherapy may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving proton beam radiation therapy     together with cisplatin works in treating patients with stage IB, stage II, stage III, or     stage IVA cervical cancer and positive lymph nodes.   "
241307|NCT01019291|"     It seems that the aldehydes and NO2, at the levels found indoor, could be the aggravating     factors for an allergic response. However this effect has not been demonstrated. The     investigators plan to study the effect of exposure to standard doses of these pollutants on     the bronchial reactivity as measured by bronchial challenge tests with dust mite extract in     volunteers asthmatic, allergic to house dust mite.   "
241308|NCT01019317|"     The goal of this clinical research study is to learn if the combination of fludarabine and     cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic     Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this     drug combination will also be studied.   "
241309|NCT01019330|"     Cardiac catheterization has traditionally been performed via access to the arterial     circulation from the femoral artery located in the groin. As an alternative to this approach,     the radial artery, located in the arm, is gaining wider use in clinical practice. Multiple     studies have demonstrated that cardiac catheterization via the radial approach has a very low     complication rate, in the short term. This study is intended to determine if there are any     differences in the long term complication rate between radial artery cardiac catheterization     as compared with femoral artery cardiac catheterization.   "
241310|NCT01019343|"     Background:        -  Previous studies have given researchers information on how the brain controls movement,          how people learn to make fine, skilled movements, and why some people have movement          disorders. However, further research is needed to learn more about the causes of most          movement disorders, such as Parkinson's disease.        -  By using small, specialized studies to evaluate people with movement disorders and          compare them with healthy volunteers, researchers hope to learn more about the changes          in the brain and possible causes of movement disorders.      Objectives:        -  To better understand how the brain controls movement.        -  To learn more about movement disorders.        -  To train movement disorder specialists.      Eligibility:        -  Individuals 18 years of age or older who have had a movement disorder diagnosed by a          neurologist and are able to participate based on the specific requirements of the small          study.        -  Healthy volunteers 18 years of age or older.      Design:        -  Participants will have a screening visit with medical history, physical examination, and          questionnaire to determine eligibility. Eligible participants will give consent to          participate in up to seven additional outpatient visits for study procedures. The number          of sessions and the procedures needed for participation depend on specific symptoms.        -  Participants must avoid drinking alcohol or caffeinated drinks (sodas, coffee, and tea)          for at least 2 days (48 hours) before each session.        -  Potential studies may include magnetic resonance imaging (MRI) scans, functional MRI          scans, electroencephalography, magnetoencephalography, transcranial magnetic          stimulation, nerve and sensory stimulation, or movement and mental tasks during any of          the above procedures.        -  This study does not provide treatment for movement disorders. Participants will not have          to stop any treatment in order to participate.   "
241311|NCT01019356|"     The investigators hypothesis is that free fatty acids (FFA) accumulation in non fatty tissues     would lead to insulin resistance and hyperandrogenism in PCOS women. Accordingly, Peroxisome     Proliferator-Activated Receptor gamma (PPARγ) agonist (rosiglitazone) would be a great     therapeutic option for PCOS as their activation induces transcription factors of gene     implicated in fatty acids metabolism.      The aim is to verify if insulin-related hyperandrogenism can be reversed in women having     polycystic ovary syndrome following an 8-week treatment with rosiglitazone compared to simple     insulin reduction with acarbose.      For the purpose of this study, 14 lean women (BMI ≤ 25 kg/m2) and 36 obese women (BMI 30-39     kg/m2) with PCOS as well as 14 lean and 14 obese control women will be recruited to determine     their insulin sensibility (insulin levels, M-value, metabolic clearance rate of glucose)and     FFA metabolism (FFA levels, rythm of apparition and disapearance of FFA) during a 75g oral     glucose tolerance test and a 2-step insulin-glucose clamp.   "
241323|NCT01019512|"     RATIONALE: The Flexitouch lymphedema system may lessen lymphedema caused by treatment for     breast cancer. It is not yet known whether the Flexitouch lymphedema system is more effective     than complex decongestive therapy in treating lymphedema. PURPOSE: This randomized clinical     trial is studying the Flexitouch lymphedema system in treating stage II lymphedema in     patients with breast cancer.   "
241324|NCT01019525|"     The purpose of this study is to characterize the posture and respiratory function of     mouth-breathing children.   "
241313|NCT01019382|"     Over 7000 patients are diagnosed with pancreas cancer every year in the UK. Only 10% have it     caught early enough to have surgery to cure it. The rest at best can undergo chemotherapy to     extend survival, but current treatments offer at best an improvement of only a few months     compared to no treatment at all. In addition only about a quarter of patients will respond to     the treatment. In addition these patients often experience profound weight loss, loss of     appetite and energy primarily because of the cancer process itself. Our hypothesis is that     the addition of fish oil infusion to gemcitabine chemotherapy will result in an improved rate     of tumour response on CT imaging.      Fish oils, or specifically the omega-3 fatty acid component, appear to have a range of     powerful anti-cancer actions. This is supported by evidence from a wide range of sources,     from laboratory experiments to basic human studies. Although this evidence specifically     includes many pancreatic cancer studies in the laboratory it has not yet been confirmed in     human trials.      Contrary to conventional chemotherapy, fish oil is a naturally occuring non-toxic compound     and so is not associated with the side-effects of chemotherapy. In fact a number of clinical     studies have demonstrated significant improvements in quality of life for pancreas cancer     patients treated with fish oil, particularly with reference to improvements in appetite and     energy levels. This is of course in addition to the anti-cancer actions.   "
241314|NCT01019395|"     This is a research study designed to look at the pharmacokinetics (distribution, breakdown,     and removal) and tolerability of a single dose of daptomycin in patients aged 3 months to 24     months who have proven or suspected infections that are caused by a specific group of     bacteria (called Gram-positive bacteria)or perioperative subjects that are receiving     prophylactic antibiotics .   "
241315|NCT01019408|"     The purpose of this study was to provide stronger evidence for extended-dose chloroquine     treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP),     Pakistan or justification for discontinuation of the policy.   "
241316|NCT01019421|"     The purpose of this study is to accept or reject the hypothesis that Lu AE58054 improves     cognition and functional outcomes in patients with moderate Alzheimer's Disease, already in     treatment with donepezil.   "
241333|NCT01019642|"     Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation     (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes     mellitus.      The objective was to evaluate the effect of vitamin D supplementation on C-reactive protein     (CRP) and insulin resistance in women with type 2 diabetes mellitus (T2DM).      The trial was conducted from March to October 2008 at the Hospital of the Mexican Social     Security in Cuernavaca, Mexico.   "
241317|NCT01019434|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Temsirolimus may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as temozolomide, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet     known whether radiation therapy is more effective when given together with temsirolimus or     temozolomide in treating patients with glioblastoma.      PURPOSE: This randomized phase II trial is studying giving radiation therapy together with     temsirolimus to see how well it works compared with giving radiation therapy together with     temozolomide in treating patients with newly diagnosed glioblastoma.   "
241318|NCT01019447|"     To compare conventional polyglactin 910 sutures with triclosan-coated polyglactin 910     antimicrobial sutures for the reduction of surgical site infections and any associated health     and economic benefits.   "
241319|NCT01019460|"     The aim of this study is to evaluate three diagnostic methods for assessing small bowel     disease in patients with suspected or known Crohn's disease. All patients are examined with     ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. However,     capsule endoscopy is not performed in patients with stenosis detected at ileo-colonoscopy,     MRI and/or CT. All investigations are described in a similar pre-defined and standardized     fashion and the radiologist and physician responsible for describing the findings at MRI, CT     and capsule endoscopy are blinded to the findings at ileo-colonoscopy. The physician in     charge of treatment receives a randomised result of either MRI, CT or capsule endoscopy.     Thereafter patients are followed during 12 months to evaluate differences in clinical outcome     depending on the randomized result. In combination with the diagnostic validity and     inter-observer agreement of MRI, CT and capsule endoscopy we seek to establish the optimal     diagnostic strategy in these two patient categories.   "
241320|NCT01019473|"     This study will assess the efficacy, safety and tolerability of AFQ056 when added to optimize     standard therapy in patients that have Huntington's disease in reducing chorea.   "
241321|NCT01019486|"     Cardiovascular disease (CVD) remains the major cause of mortality and morbidity in both type     1 (T1D) and type 2 (T2D) diabetes patients; modifications of traditional CVD risk factors     have had a limited impact. This project called Regadenoson Blood flow in Type 1 Diabetes     (RABIT1D) and is proposed as a sub-study of the Coronary Artery Calcification in Type 1     Diabetes (CACTI) study, which has established a unique cohort of 656 T1D patients (age 20-55,     minimal diabetes duration of 10 yrs) and 764 non-diabetic controls. This cohort is being     followed for progression of coronary artery calcification (CAC) measured using the electron     beam tomography (EBT) for development of clinical CVD. Participants have been well     characterized during the baseline examination (4/00-3/02) and two follow-up re-examinations 3     and 6 years later. The study has provided important insights into the risk factors and     possible prevention of premature CVD in T1D. We are proposing assess a subset of this     population to determine vasodilatory reserve as it relates to early coronary atherosclerosis     in T1D.      Hypothesis: that myocardial blood imaging (MBF) reserve can be measured in Type 1 diabetes     mellitus (DM) using regadenoson stress cardiac magnetic resonance and that significantly     reduced MBF is a marker of extensive atherosclerotic disease correlated to coronary arterial     calcification, plaque formation and impaired vasodilatory reserve.   "
241322|NCT01019499|"     The purpose of this study is to investigate the effects of berry consumption on indicators of     cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).   "
241325|NCT01019538|"     The purpose of this study is to evaluate if supplemental oxygen during air travel can be     reliably titrated using a Hypoxia-altitude simulation test (HAST). Also, the effect of oxygen     supplementation given with the various oxygen equipment allowed for air travel is studied.   "
241327|NCT01019564|"     The aim of this trial is to assess Complete Easy Rub compared to a competitor multi-purpose     solution in terms of lens cleanliness, subjective response and ocular response, when lenses     are worn bilaterally on a daily wear basis for two months.      The hypotheses for this trial are:        -  Lens cleanliness measures between solutions will be no different.        -  Subjective ratings between solutions will be no different.        -  Ocular response between solutions will be no different.   "
241328|NCT01019577|"     The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in     subjects with metastatic breast cancer previously treated with an anthracycline and who are     taxane resistant.   "
241329|NCT01019590|"     The objective of this study was to investigate the bioequivalence of Mylan's olmesartan     medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg     tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fed     conditions.   "
241330|NCT01019603|"     The purpose of this study is to assess systemic exposure of a new foam formulation of     tazarotene, 0.1% compared with Tazorac Gel, 0.1%. The study design and dosing regimen are     based on previous clinical studies with Tazorac Gel and Tazorac Cream.   "
241331|NCT01019616|"     The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled     study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can     increase distant disease free survival(DDFS) in operable patients non-response to primary     chemotherapy.   "
241332|NCT01019629|"     To determine if patients with a deficiency of alpha-galactosidase A are at-risk for cardiac     complications that commonly occur in the general population   "
241334|NCT01019655|"     The purpose of this study is to investigate whether heparin is an effective treatment in     pregnant women at risk for thrombosis and other pregnancy-associated complications.   "
241337|NCT01019694|"     The primary objective of this study is to evaluate long-term safety and patient acceptability     of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol     Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT     Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.   "
241338|NCT01019707|"     This is a study of 4 nontreatment seeking individuals who were MA-dependent and the safety     and tolerability of atomoxetine. This double-blind, placebo-controlled, within-subjects study     is to determine the safety and tolerability of atomoxetine.      MA abusing participants will undergo a 1-day outpatient screening and if it is safe for the     participants to proceed with the study they will participate in two inpatient components of     the study that will occur in the University of California Los Angeles (UCLA) General Clinical     Research Center (GCRC). The first inpatient stay will be 15 days, and the second will be a 9     days stay that includes drug administration and assessments. There will be at least a two     week interval between inpatient components. During the inpatient components participants will     receive alternating study drugs; atomoxetine or placebo and four sessions of IV MA     administration or saline.   "
241339|NCT01019733|"     The purpose of this study is to determine whether the plasticity of autologous intrathecal     hematopoietic cells would improve the neurologic evolution of the pediatric patients with     hypoxic/ischemic brain injury.   "
241340|NCT01019746|"     The purpose of this study is to compare the administration of the standard anesthetic agent     (propofol) using this automatic system with the manual administration of propofol by the     anesthesiologist.   "
241341|NCT01019759|"     The hypothesis being studied is that add-on arrhythmia surgery in patients with atrial     fibrillation (AF) undergoing valvular or coronary surgery improves quality of life, is     cost-effective, reduces perioperative and long-term morbidity associated with AF.   "
241342|NCT01019772|"     The purpose of this study is to evaluate and compare the immunogenicity and safety of     LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) to that of Hiberix™     at vaccination in healthy infants at their 2, 4, and 6 months of age.   "
241343|NCT01019785|"     During IVF treatment women will be randomized into supplementation with a high or a low dose     of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home     rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA,     Diabetes) 2.Thrombin generation   "
241344|NCT01019798|"     Sunitinib shows anti-tumor activity in a variety of human non-small cell lung tumor ex vivo     models. Many Phases II and III clinical trials of sunitinib in several solid tumors are     completed or still ongoing. So far, the efficacy of sunitinb has been confirmed by the phase     III trial for imatinib-resistance or intolerance advanced gastrointestinal stromal tumor     patients. And sutent was approved to effective by two phase II trials in advanced renal cell     carcinoma patients after failure of immunotherapies, and one phase III trial in     treatment-naive advanced renal carcinoma patients. Sunitinib (SUTENT ®) has been approved by     U.S. Food and Drug Administration (FDA) for the treatment of advanced renal carcinoma     patients and in gastrointestinal stromal tumor patients who are intolerant or progressed     after imatinib mesylate. European Medicines Agency (EMEA) conditionally granted the marketing     approval for the treatment of metastatic renal carcinoma patients after failure of     immunotherapy.      A phase II trial (A6181040 study) on non-small cell lung cancer patients treated with     sunitinib alone showed anti-tumor activity. In 63 enrolled patients treated with 4/2 schedule     (4 weeks treatment, then two weeks interruption), 7 patients are confirmed partial response     (overall response rate, 11%), and median progress-free time is 14.3 weeks. Presently, a phase     III study is underway on non-small cell lung cancer patients followed by and now is under     recruiting.      Non-small cell lung cancer cells often over-express vascular endothelial growth factor (VEGF)     receptors. Besides, the expression of the VEGF ligands is also correlated with increased     tumor angiogenesis, as well as shortened survival time. One study treated with VEGF-directed     monoclonal antibody (bevacizumab) and VEGFR and platelet-derived growth factor receptor     (PDGFR) small molecule inhibitors (sunitinib) showed that some non-small cell lung cancer     patients are with anti-tumor activity.      The chemotherapy drugs, such as docetaxel and platinum-based compounds, were with evidence     that they have direct cytotoxicity to cancer cells. Therefore, the investigators are paying     attention to the efficacy of combining sunitinib and conventional chemotherapy in this study.      The study is designed as first line of salvage therapy on metastatic or unresectable     non-small cell lung cancer patients. The main goals of this study is to evaluate the overall     response rate (ORR) and duration of response (DR) of sunitinib in combinational with     docetaxel and cisplatin in chemotherapy-naive advanced or metastatic non-small cell lung     cancer patients.   "
241345|NCT01019811|"     The purpose of this study is to introduce a new operative technique for reconstruction of     fingertip degloving injury.   "
241346|NCT01007539|"     The purpose of the study is to determine if cytidine 5'diphosphocholine (CDP-choline, a     naturally occurring chemical in your body) has efficacy in reducing the methamphetamine     craving of the subjects with methamphetamine dependence craving and helping them maintain the     abstinence. In addition, investigators will measure the brain N-acetyl aspartate (a biologic     marker for neuronal viability) level of participants to determine if brain deficits induced     by methamphetamine may recover by taking CDP-choline.   "
241347|NCT01007552|"     To assess the proposed therapy for patients with advanced gallbladder or biliary cancers.   "
241348|NCT01007565|"     The investigators undertook to evaluate early postoperative pain levels after the volar     plating of distal radius fractures performed under regional anesthesia, and to determine     whether periarticular multimodal drug injections into the joint, ligament, periosteum,     subcutaneous tissue, and skin, and into interosseous and superficial radial nerves (as an     additional sensory nerve block) provide additional pain management benefits.   "
241349|NCT01007578|"     The purpose of this study is to determine plasma levels of paclitaxel and catheter     tolerability subsequent to treating patients with peripheral arterial occlusive disease     (PAOD) with paclitaxel-coated balloon catheters.   "
241350|NCT01007591|"     An international, multi-centre, prospective, randomised, double-blind, active-controlled,     2-arm, parallel group, 8-week, phase 3 clinical study in paediatric patients (aged 6 to 17     years) with psoriasis vulgaris on the face and on the intertriginous areas   "
241351|NCT01007604|"     The purpose of this study is to evaluate the efficacy of a non-invasive peristaltic pulse     pneumatic device (PCD) in the treatment of intermittent claudication in patients having     documented peripheral arterial disease (PAD). The pneumatic device to be studied is FDA     approved for the treatment of venous disease. While anecdotal evidence exists supporting a     decrease in claudication symptoms, there are no previously published data on studies     employing this compression device in the treatment of arterial disease. The investigators'     primary hypothesis is that patients randomized to the intervention arm of the trial will     experience an increase in mean walking ability as compared to the group receiving medical     standard of care.   "
241352|NCT01007617|"     Oral mucositis represents a major complication of cytotoxic chemotherapy among cancer in     children. Low-power laser therapy (LPLT) has been used to reduce the incidence of oral     mucositis in patients who are receiving high-dose chemotherapy. The aim of this study is to     compare two preventives energies delivered of LPLT to oral mucosa in decreasing the severity     of mucositis in children.   "
241353|NCT01007630|"     A decrease or loss of the sense of smell is very common in patients with Parkinson's Disease     even in the earliest stages of the disease. There have been no treatments that have been     proven to improve sense of smell in patients with Parkinson's Disease.      Rasagiline (brand name: Azilect) was approved by the U.S. Food and Drug Administration (FDA)     on May 16th 2006 to be used by Parkinson's patients to treat the motor symptoms associated     with the disease. The purpose of this study is to see if there is change in sense of smell     after starting Rasagiline.   "
241354|NCT01007643|"     To determine the utility of the Wii Fit TM interactive video game program in patellofemoral     symptom resolution, development of increased muscle strength and flexibility as a result of     increased compliance with home exercises in adolescent females with patellofemoral syndrome.   "
241355|NCT01007656|"     -  Study design is multiple-dose, open-label study        -  The purpose of this study is to evaluate the safety after twice daily GD Antrodia          camphorata administration for 90 days in 30 healthy adult subjects.             -  Primary objective: The mean change from baseline in laboratory assessment after               twice daily GD Antrodia camphorata administration at 90th day in 30 healthy adult               subjects.             -  Secondary objective: The mean change from baseline in laboratory assessment after               twice daily GD Antrodia camphorata administration at 10th, 20th, 30th, 45th and               60th day in 30 healthy adult subjects.        -  Safety Measurement:             -  including SGOT(AST), SGPT(ALT), albumin, glucose, creatinine, uric acid,               cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, D-Bil, BUN, TP, GLO               will be documented at 1st, 10th, 20th, 30th, 45th, 60th and 90th day.             -  vital signs (heart rate, blood pressure, and body temperature) will be documented               at 1st, 10th, 20th, 30th, 45th, 60th and 90th day.             -  Subjects will be monitored throughout the confinement portion of the study.   "
241356|NCT01007669|"     The purpose of this study is to evaluate the effect of specified worksite physical-activity     interventions on musculoskeletal disorders in an industry with physical heavy workload.   "
241357|NCT01007682|"     This study aims at identifying risk factors for the development of intrusive reexperiencing     symptoms. In particular, the investigators examine the influence of working memory capacity     and thought suppression on the occurrence of unpleasant memories of a negative experience.      Hypothesis: People with high working memory capacities (HWMC) are able to successfully     suppress memories of an unpleasant experience (presentation of a distressing movie). In     contrast, in people with low working memory capacities (LWMC), attempts to suppress memories     of an unpleasant experience inadvertently lead to an increase of these memories.      Study phase one: Assessment of working memory capacity in 200 healthy participants by means     of a computerized task. Selection of 50 participants with HWMC and of 50 participants with     LWMC who participate in study phase two.      Study phase two: Presentation of a distressing movie and subsequent assessment of memories of     the movie during several days in the daily life of participants. Comparison of 4 groups     regarding the frequency of instructions in daily life:(group 1: HWMC participants who are     instructed to suppress thoughts of the movie, group 2: LWMC participants who are instructed     to suppress thoughts of the movie, group 3: HWMC participants who are instructed to allow the     occurence of thoughts of the movie, group 4: LWMC participants who are instructed to allow     the occurence of thoughts of the movie)   "
241371|NCT01007877|"     Rationale: Sleepiness behind the wheel is the cause of many traffic accidents. It is claimed     that a 15-minute break and consuming an energy drink such as Red Bull® Energy Drink     counteracts driver sleepiness.      Objective: The objective of this study is to compare driving simulator performance after (1)     a 15-minute break with placebo, (2) a 15-minute break with Red Bull® Energy Drink, and (3)     continued driving.      Study design: A double-blind, placebo-controlled crossover study. Study population: Healthy     human volunteers, 21-35 years old.      Intervention: Each subject performs 3 test days:        1. 4 hours continued driving        2. 2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving        3. 2 hours driving, a 15-minute break + placebo, followed by 2 hours driving Main study          parameters/endpoints: Standard Deviation of Lateral Position (SDLP), i.e. the weaving of          the car.   "
241372|NCT01007890|"     The objective of this study is to develop a biomarker to predict pathological complete     response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker     would assist physicians in selecting the most effective chemotherapy for the individual     patient.   "
241358|NCT01007695|"     The investigators' hypothesis is that valproic acid given before surgery for newly diagnosed     breast cancer will increase breast tumor histone acetylation at tolerable doses and that the     increase in breast tumor histone acetylation will correlate with valproic acid blood levels     and changes in peripheral blood white blood cell histone acetylation. Published in vitro     studies have shown sensitivity of breast cancer cells to histone deacetylase inhibitors     (Fortunati et al., 2008; Fuino et al., 2003; Hodges-Gallagher et al., 2007; Olsen et al.,     2004). The investigators' gene array data predict sensitivity to valproic acid in over half     of breast cancers [Bild, unpublished]. The investigators hypothesize that in women with newly     diagnosed breast cancers valproic acid will have an unacceptable toxicity rate less than 15%     at doses that increase tumor histone acetylation and that valproic acid will decrease the     Ki-67 in at least half of breast tumors by over 20%. The investigators also hypothesize that     their genomically-derived signature for sensitivity to valproic acid (GDSS-VPA) can be used     to predict which tumors will have a decrease proliferation as measured by Ki-67 by at least     20%. The investigators hypothesize that valproic acid levels and histone acetylation levels     in peripheral leukocytes will correlate with a decrease in the Ki-67 proliferation index by     20%. The investigators hypothesize that DCE-MRI imaging studies will provide an accurate and     quantitative means of assessing tumor response to valproic acid. Finally, the investigators     hypothesize that response to valproic acid will not be affected by intrinsic breast cancer     subtype.   "
241359|NCT01007708|"     The purpose of this study is to evaluate the safety and efficacy of topical application of     IDP-108 versus vehicle in treating patients with onychomycosis.   "
241360|NCT01007721|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     BI 671800 ED using three dose levels of BI 671800 ED (50 mg, 200 mg and 400 mg), administered     twice daily compared to FP (fluticasone propionate) nasal 100 mcg per nostril qd in the     morning or Montelukast 10 mg qd am given for 2 weeks in patients with SAR (seasonal allergic     rhinitis) out of season using an environmental exposure chamber in patients known to be     sensitive to the aero-allergen Dactylis glomerata.   "
241361|NCT01007734|"     The purpose of this study is to evaluate with sufficient precision and according to gender     the determining independent factors of quality of life related to respiratory status of     patient with moderate to severe COPD.   "
241362|NCT01007747|"     The purpose of this study is to determine if Geranium oil will relieve a variety of     neuropathic pain and some pain relief will last more than 48 hours.   "
241363|NCT01007760|"     The purpose of this study is to determine the vascular effects of brief second-hand smoke     exposure on normal healthy individuals.   "
241364|NCT01007773|"     The aim of this study is to assess the safety and feasibility of dexmedetomidine as an     adjunct to conventional sedative therapy compared to conventional sedative therapy alone in     patients with severe traumatic brain injury.   "
242029|NCT01023958|"     The primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in     patients with locally advanced, metastatic or recurrent urothelial cancer after failure of     first line or adjuvant/neoadjuvant chemotherapy.   "
241365|NCT01007786|"     Shunt failure remains a significant problem in pediatric patients with hydrocephalus. If     reliable techniques for the accurate placement of ventricular catheters can be developed,     shunt survival may improve. The purpose of this study is to assess the efficacy and safety of     the ultrasound guided shunt insertion technique in the hands of experienced surgeons. The     primary outcome measure is ventricular catheter location determined from post-operative brain     images. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a     network established to conduct multi-institutional clinical trials on pediatric     hydrocephalus. Pediatric neurosurgeons at HCRN centers enrolled in this study will perform     either ultrasound guided shunt surgery or a conventional shunt surgery. Patients who undergo     conventional shunt surgery will serve as a contemporary control group.   "
241366|NCT01007799|"     The purpose of this study is to examine if vitamin D improves the symptoms of chronic     sinusitis.   "
241367|NCT01007812|"     The purpose of this trial is to compare the performance of two different contact lenses for     contact lens wearers with astigmatism.   "
241368|NCT01007838|"     The purpose of this study is to investigate the effects of a 12 week progressive resistance     training during haemodialysis on muscle quantity and physical functioning in chronic kidney     disease patients receiving maintenance haemodialysis.      It is hypothesised, based on previous literature involving similar resistance training     protocols in other catabolic conditions, that the resistance training will result in a     significant increase in muscle quantity as well a physical function.   "
241369|NCT01007851|"     GnRH agonist administration in the luteal phase was reported to beneficially affect clinical     outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single     dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles     stimulated with the fixed GnRH antagonist protocol. Women undergoing embryo transfer     following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol were     included. In addition to routine luteal phase support with progesterone women were randomized     to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing     pregnancy rate was the primary outcome measure.   "
241370|NCT01007864|"     The purpose of this clinical trial is to investigate the effects of the non-ergot dopamine     agonist piribedil on vigilance and cognitive performances in patients with Parkinson's     disease in comparison with other oral non-ergot dopamine agonists.      It should be tested whether piribedil is superior to continued pramipexole or ropinirole     treatment regarding improvement of reduced vigilance and cognitive performance in patients     with Parkinson's disease.   "
241373|NCT01007903|"     This is a pilot randomized controlled trial of feasibility and preliminary effects of a 12     week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary     disease   "
241374|NCT01007916|"     The purpose of this study is to compare the performance of commercially marketed contact     lenses to habitual contact lenses in a selected segment of the contact lens wearing     population.   "
241375|NCT01007929|"     The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics     of a single oral dose of [14C] AZD1236 in healthy male subjects.   "
241376|NCT01007942|"     This phase III, double-blind, placebo-controlled multinational study will assess the     combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine     and trastuzumab with respect to progressive-free survival and over survival in HER2/neu     positive women with locally advanced or metastatic breast cancer who are resistant to     trastuzumab and have been pre-treated with a taxane.   "
241377|NCT01007955|"     The purpose of this research is to further study the effect weight loss after gastric bypass     surgery has on the heart and blood pressure and on how the body uses or metabolizes the     sugars, fats and proteins we eat. Additionally, the researchers want to study fat tissue for     gene patterns which may be responsible for where we carry fat on our bodies, as well as look     carefully at a possible link between adipose tissue and insulin resistance. The researchers     also want to evaluate the liver for the presence of fatty liver, which is common in people     with obesity and is associated with insulin resistance, as well as study the liver for gene     patterns which may be associated with non-alcoholic liver disease.      Evaluating cardiovascular function and endocrine function before and after gastric bypass     surgery, as well as studying adipose and liver tissue may help us understand the link between     obesity, insulin resistance, fatty liver disease, high blood pressure and health problems     such as diabetes and heart disease. Consequently, this may help in the future by identifying     those who will benefit most from gastric bypass surgery.   "
241394|NCT01010997|"     The FORESEE HOME is intended for the early detection of central and paracentral     irregularities (abnormalities) in the visual field, most commonly associated with AMD.     However, the device has ability to detect the development of the lesion post treatment and     therefore to asses in determination of the next treatment.   "
241597|NCT01020097|"     Rationale: Diagnostic procedures, such as positron emission tomography, using the drug     fluorine F 18-EF5 to find oxygen in tumor cells may help in planning cancer treatment.      Purpose: This clinical trial studies fluorine F 18-EF5 positron emission tomography in     assessing hypoxia in patients with newly diagnosed stage I, stage II, stage III, or stage IV     squamous cell cancer of the oral cavity, oropharynx, and larynx.   "
241378|NCT01007968|"     Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel     cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC     inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients     with solid tumors and hematological malignancies.      To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with     solid tumors and hematological malignancies participating in several phase I/II clinical     studies. Panobinostat PK does not appear to be different in patients with solid tumors and     hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is     yet to be elucidated.      Kidney and liver are involved in the elimination and metabolism of panobinostat. The current     study is designed to evaluate the impact of hepatic function status on panobinostat PK.   "
241379|NCT01007981|"     The investigators hypothesize that the relation between mechanical and hemodynamic left     ventricular dyssynchrony might better predict response to Cardiac Resynchronization     Device(CRT) than currently existing echo indices.   "
241380|NCT01007994|"     The proposed study will investigate the effect of chronotherapeutic alteration of     anti-hypertensive medication on nocturnal hypertension and end-organ injury in pediatric     renal transplant recipients who are non-dippers. Additionally, the investigators aim to     examine the association between response to intervention, serum adiponectin levels and     adiponectin gene polymorphisms. The investigators hypothesize that (1) evening administration     of anti-hypertensive medication will convert subjects from non-dipper to dipper status,     improve mean nocturnal blood pressure (BP), and improve nocturnal BP load, (2) evening     administration of anti-hypertensive medication will reduce albuminuria, left ventricular mass     index (LVMI), rate of decline of glomerular filtration rate (eGFR) and will decrease pulse     wave velocity (PWV), and (3) lower adiponectin levels and presence of adiponectin gene     polymorphisms will be associated with less of a response to the intervention.   "
241381|NCT01008007|"     The purpose of the study is to assess the safety and effect of Viusid (bags of 4 grams)     administration in the treatment of acute fever of viral etiology as diagnosed by clinical,     hematologic and serologic parameters. The duration of this open and randomized phase 2     clinical trial will be 6 days. The estimated number of persons with acute fever of viral     etiology to be recruited and randomized for the study is 200. The primary outcome measure:     platelet, leukocyte and granulocyte count will be assessed at the beginning and the end of     the study.   "
241382|NCT01008020|"     The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the     prevention of influenza infection.   "
241383|NCT01008033|"     The purpose of this study is to evaluate the safety and efficacy of topical application of     IDP-108 versus vehicle in treating patients with onychomycosis.   "
241384|NCT01008046|"     The purpose of this study is to compare and determine the efficacy of combined N-acetyl     cysteine and clomiphene citrate(CC)with combined metformin and CC in infertile women with     Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.   "
241385|NCT01008059|"     To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A     activity.   "
241386|NCT01010893|"     To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in     adults and elderly people, with the objective to verify efficacy and tolerability of the     study drug.   "
241387|NCT01010906|"     This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir     (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy     matched control participants. The primary hypothesis is that the area under the curve (AUC)     (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic     insufficiency is similar to that observed in healthy matched controlled participants.   "
241388|NCT01010919|"     Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of     arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled,     double blind, dose-escalating trial is to determine the safety and tolerability of a     proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary     objectives are to assess effects on the signs and symptoms of this disorder. Individuals     greater than 50 years of age with OA of the hip or knee will be eligible for trial entry.   "
241391|NCT01010958|"     For patients initially presenting with localized sarcoma the standard of care is surgery     followed by with radiation therapy (if feasible). Subsequent or adjuvant cytotoxic based     chemotherapy even for aggressive sarcoma histopathologies (as commonly done for colorectal     cancer or breast cancer) is controversial since over 20 individual adjuvant randomized     clinical trials have not been able to consistently demonstrate a statistically significant     improvement in overall survival. Maturation or differentiation therapy provides an     opportunity to fundamentally change the biology of the underlying cancer (and thus its     overall prognosis) by promoting cellular maturation within that cancer. A change from a     poorly 'differentiated/high grade' tumor to a well 'differentiated/low grade' tumor is     attainable and can change an individual's median time of survival from months to decades. The     investigators have significant preclinical data that differentiation therapy using a group of     drugs referred to as histone deacetylase inhibitors (such as Valproate, also a commonly used     and safe anti seizure medication) is feasible for sarcomas. This approach has not been     clinically addressed in solid tumors. Since adjuvant therapy is controversial for sarcomas,     and building on the investigators' preclinical data, adjuvant based differentiation therapy     using valproate would be predicted to be both safe and potentially extremely beneficial in     terms of a) increasing the time to disease recurrence, b) improving the histology upon     recurrence; and c) improving overall survival in patients with sarcomas.      Patients with high grade sarcomas will receive Valproate in the adjuvant setting daily and     clinically/radiologically followed until recurrence. Relapse free survival, time to local     failure, time to distant failure, overall survival, and comparative histopathology of primary     and recurrence will be assessed.   "
241392|NCT01010971|"     This clinical research study will evaluate the safety and effectiveness of two doses of an     investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of     seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm     study eligibility, followed by a Single-Blind Placebo Run-in period to acclimate subjects to     the proper use of the study medication and to assess the subject's severity of SAR symptoms,     followed by a 2-week double-blind treatment period to assess the safety and effectiveness of     the study medication when given to eligible subjects.   "
241393|NCT01010984|"     The purpose of this study is to determine if LC beads loaded with Doxorubicin are a safe and     effective treatment for melanoma that has spread to the liver.   "
241395|NCT01011010|"     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as doxorubicin hydrochloride and mitomycin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking     the blood flow to the tumor. Giving sorafenib tosylate together with chemoembolization may     kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects of sorafenib tosylate when given     together with chemoembolization with doxorubicin hydrochloride and mitomycin in treating     patients with liver cancer that cannot be removed by surgery.   "
241396|NCT01011023|"     Objective. To study the role of nasogastric drainage to prevent postoperative complications     in children with <b>distal</b> elective bowel anastomosis. Summary Background Data.     Nasogastric drainage has been used as a routine measure after gastrointestinal surgery in     children and adults, to hasten bowel function, prevent post operative complications and     shorten hospital stay. However, there is no former study that states in a scientific manner     its benefit in children. Methods. The investigators performed a clinical controlled,     randomized trial, comprising 60 children that underwent distal elective bowel anastomoses     comparing post operative complications between a group with nasogastric tube in place (n=29)     and one without it (n=31). <b>As an equivalence study the investigators expected that the two     techniques were equivalent.</b> Statistics: Descriptive statistics for global description.     Student's t test for quantitative variables and chi square test for qualitative variables.     Considering statistically significant a p-value less than 0.05. <b>Being an equivalence     study, the default delta generated by the Stata command equim was used to demonstrate the     equivalence between both groups.</b> Results: Demographic data and diagnosis were comparable     in both groups (p=NS). No anastomotic leakage or entero-cutaneous fistulae was found in any     patient. The investigators demonstrated equivalency since each confidence interval is     entirely contained within delta, except for one variable (beginning deambulation), in which     equivalency is suggested. There were no significant differences between groups in abdominal     distention, infection, or hospital stay variables. Only one patient in the experimental group     required placement of the nasogastric tube due to persistent abdominal distension (3.2%).     Conclusions. The routine use of nasogastric drainage can be eliminated after distal elective     intestinal surgery in children. It's use should be individualized.   "
241397|NCT01011036|"     The investigators will use an intradermal capsaicin injection in the forearm to induce a     state of localized pain. This localized pain will be measured by different means, and     analysed locally and distally by so called quantitative sensory testing. The primary endpoint     of measure is the difference in pain perception with and without     benzodiazepines/GABA-Agonists around the injection point of capsaicin. The secondary     endpoints are to measure pain modulation locally and distally by different quantitative tests     as electricity, pressure pain thresholds, and ice water tests.      The investigators' hypothesis is that clobazam induces higher pain thresholds as placebo and     less sedation than the control medication clonazepam.   "
241398|NCT01011049|"     The purpose of this study is to generate additional data on the immunogenicity and safety of     revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.      Primary Objective:        -  To evaluate and describe the safety profile of revaccination with Fluzone ID for all          participants.      Secondary Objective:        -  To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.   "
241399|NCT01011062|"     The study aims to investigate the effect of acute angiotensin receptor blockade on insulin     action/insulin resistance and expressions of selected adipocytokines in subcutaneous adipose     tissue in insulin-resistant subjects with type 2 diabetes and healthy controls.      Hypothesis: Changes in adipocytokine concentrations and/or expressions and different     reactions to acute in vivo induced hyperinsulinemia and angiotensin receptor blockade will be     found in patients with type 2 diabetes compared to healthy subjects. A significant     relationships between insulin sensitivity and selected adipokines and intracellular fat     content and high energy phosphates in soleus muscle will be documented in healthy     individuals, while no significant relation will be found in patients with type 2 diabetes.   "
241400|NCT01011075|"     This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a     PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients     with advanced, non-small cell lung cancer.   "
241401|NCT01011088|"     A large number of studies have investigated the psychological disorders occurred in     postpartum women, and found that postpartum psychosis is common in new mothers.      However, the situation of paternal psychological status after they had their first baby is     not assessed. The investigators hypothesized that they had a high occurrence of paternal     psychosis after first baby born. In addition, different factors might influence its onset and     development in new fathers.   "
241414|NCT01011257|"     The investigators will test the hypothesis that aspirin or clopidogrel taken twice daily will     augment their antiplatelet efficacy in patients with an elevated platelet turnover (as     measured by the proportion of reticulated (young) platelets) compared with once daily dosing.   "
241402|NCT01011101|"     Background:        -  Researchers are studying how humans are able to move our eyes to a remembered region          even when the target has disappeared. The ability to do this suggests that the brain can          keep track of where the eyes have looked, without an external target for continued          reference. This is called corollary discharge.        -  Other research has indicated that patients with schizophrenia might have difficulty          monitoring their eye movements. The corollary discharge process may be defective in          patients with schizophrenia, and perhaps delayed in time. Researchers have developed a          test to examine this possibility in the hope of learning more about schizophrenia and          eye movement.      Objectives:      - To assess whether there is a defect in internal monitoring of eye movements in patients     with schizophrenia.      Eligibility:        -  Individuals over 18 years of age who are able to give informed consent and are able to          concentrate on a 20-minute task that involves following projected targets and moving          their eyes to remembered locations.        -  Individuals with schizophrenia will be recruited from an ongoing NIH protocol studying          schizophrenia.        -  In addition healthy will be recruited for this protocol.      Design:        -  Researchers will check participants' vision in each eye, and ask them to sit at a          machine that measures eye movement in order to complete research tasks. Researchers will          monitor participants ability to complete these tasks.        -  The first task involves simply following a target that jumps to different parts of the          screen.        -  The second is a 2-step task, in which a participant is asked to look at two separate          light targets and then look at the remembered target positions when the lights are off.        -  This protocol does not provide treatment. Participants will remain under the care of          their own physicians during participation in this protocol.   "
241403|NCT01011114|"     The purpose of the study is to determine whether cinacalcet, used in patients with secondary     hyperparathyroidism to control excessive parathyroid hormone, can normalize low blood     phosphorus that is commonly seen in patients who have had a kidney transplant.   "
241404|NCT01011127|"     The investigators hypothesize that pravastatin and rosuvastatin may have different metabolic     effects in hypercholesterolemic patients.   "
241420|NCT01011335|"     This study involves the use of investigational vaccines. A vaccine is a medicine that causes     the body to make antibodies. Antibodies help destroy foreign substances that enter the body.     The purpose of this study is to find the right dose of a new vaccine that is safe and     produces a good immune response (how well your body recognizes and defends itself against     harmful foreign substances). There are two Staphylococcus aureus toxoids (components or     antigens) under investigation in this study; one of them is a protein known as rAT and the     other is a protein known as rLukS-PV. They are being developed to see if they are effective     at preventing infections caused by the bacteria Staphylococcus aureus.   "
241405|NCT01011140|"     The purpose of this study is to assess palliative care physicians' attitudes, beliefs and     practice patterns related to parenteral hydration at the end of life in Latin America and     Spain.      Objectives:        1. To assess palliative care physicians' attitudes, beliefs and practice patterns related          to parenteral hydration at the end of life in Latin America and Spain.        2. To assess cross-national differences in practice patterns related to parenteral          hydration at the end of life. (Latin America vs. Spain).        3. To determine the percentage of physicians who practice parenteral hydration at the          end-of-life in the hospital setting and the home setting.        4. To examine the association between providers' parenteral hydration practice patterns          and:             -  1. provider demographic characteristics;             -  2. specific characteristics of their practice settings; and             -  3. training and experience in end of life care;        5. To determine which factors most predict the practice of parenteral hydration at the end          of life among palliative care physicians.   "
241406|NCT01011153|"     This survey study purposes to determine and compare the biopsy/referral sensitivity and     specificity of MelaFind to the average biopsy/referral sensitivity and specificity of     dermatologists. 241 subjects logged into system but only 183 signed consents and completed     the intake survey. Out of these 183, 155 were accounted for in the data analysis after     exclusions were removed from the pool of subjects.   "
241407|NCT01011166|"     This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of     IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with     hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for     future, longer term studies.   "
241408|NCT01011179|"     This study will evaluate the feasibility of Teens Taking Charge: Managing Arthritis On-line     intervention that will help adolescents with arthritis to better manage their disease and     improve their health-related quality of life (HRQL).   "
241409|NCT01011192|"     The aim of this study was to assess the clinical performance of two different ke0s (fast and     slow) in terms of propofol effect-site concentration (Ce) during the loss and recovery of     consciousness, using Marsh's pharmacokinetic model.The hypothesis to be tested was that the     Ce of propofol predicted by the slow ke0 in the loss and recovery of consciousness is     similar, differently from the fast ke0.   "
241410|NCT01011205|"     Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which     may have the potential to cause fewer kidney problems.   "
241411|NCT01011218|"     Primary Objective:        1. To provide preliminary data on the effects of armodafinil and Brief Behavioral Therapy          for Insomnia (BBT-I) (alone or in combination) on insomnia in breast cancer patients          receiving chemotherapy.      Secondary Objectives:        1. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in          combination) on cancer-related fatigue (CRF) in breast cancer patients receiving          chemotherapy.        2. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in          combination) on QOL in breast cancer patients receiving chemotherapy.        3. To provide preliminary data on influence of armodafinil and BBT-I (alone or in          combination) on endocrine and inflammatory physiological markers (measured by cortisol          and inflammatory cytokines markers)   "
241412|NCT01011231|"     The purpose of this study is to assess the efficacy, of treating patients with recurrent     glioblastoma using Gamma-Knife Radiosurgery (GKS) to target a tumor volume defined by a     combination of gadolinium enhancement and magnetic resonance spectroscopy (MRS). This is a     single center, Phase II trial. A total of 40 glioblastoma patients will be enrolled into the     primary arm of the trial. In addition, a minimum of 10 patients with recurrent anaplastic     (grade III) gliomas and a minimum of 10 patients with recurrent low-grade (grade II) gliomas     will be enrolled into exploratory arms.      The investigators hypothesize that the use of a combination of gadolinium enhancement and     elevated Cho:NAA ratio via MRS to determine the treatment target volume for Gamma Knife may     be an effective way to treat focally-recurrent glioblastoma.   "
241477|NCT01012089|"     The purpose of this study is to:        1. Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and          peritoneal dialysis (PD).        2. Determine urine, HD and PD clearance of daptomycin.   "
241415|NCT01011270|"     Workers in the various branches of the investigators industrial society can be considered as     a group susceptible to risks due to the nature of its activities related to the intense     demands of their work units with varying degrees of physical overload. Among the risk factors     involved in postural genesis of occupational low back pain is work in uncomfortable     positions, such as maintenance of static postures for long periods of time and frequent     implementation of flexion, extension and trunk rotation.The association between body     instability (lack of postural balance) and back pain is seen with some frequency, especially     in working groups.   "
241416|NCT01011283|"     The purpose of this study is to compare the response of patients with Intermediate or High     Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.   "
241417|NCT01011296|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.   "
241418|NCT01011309|"     The purpose of this study is to determine the efficacy, safety, and immunogenicity of an     investigational vaccine being developed for the treatment of leishmaniasis, including     cutaneous leishmaniasis (CL). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a     Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.   "
241419|NCT01011322|"     The participation in this clinical study will last approximately 21 weeks with a 1 week     screening period and a 12 weeks treatment duration. If the study doctor finds, that the     patients disease has significantly improved he/she will enter a treatment free follow-up     period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1     telephone follow-up call.   "
241421|NCT01011348|"     Goal: The investigators propose to test whether giving the supplement coenzyme Q10 (Q10)     improves symptoms and subjective health in Gulf War veterans (GWV) with chronic,     multi-symptom health problems.      Rationale: Direct empirical evidence, in groups that are not GWV, has supported benefit of     Q10 to many of the symptoms that GWV are at heightened risk of experiencing - such as     fatigue, muscle pain, and cognition, which are syndrome-defining conditions. In addition, Q10     has also been reported to benefit other symptoms arising at increased rates in GWV, including     headaches, sleep disturbances, and breathing problems. This provides a strong rationale for     testing whether Q10 will have similar benefit to these symptoms in GWV.      Method: 46 GWV with chronic health problems will participate.The design is a randomized,     double-blind, placebo-controlled crossover study. Each subject will be crossed over between     Q10 and an identical placebo, receiving each agent twice, for 3.5 month periods. In one of     the Q10 phases, a lower dose of Q10 will be used - 100mg three times a day; while in one a     higher dose will be used - 300mg three times a day. Neither subjects nor investigators will     know which substance each subject is receiving in which phase. Subjects will be randomly     assigned to one of four crossover orders.      Assessments: Assessments will include subjective quality of life; symptoms that are syndrome     defining for Gulf War illness (like fatigue and muscle problems); and other symptoms and     conditions reported to occur more commonly in GWV (like sleep problems). Analyses will show     whether Q10 led to improvements when compared to placebo; whether higher Q10 doses improved     outcomes more than lower doses; and whether people with certain symptoms or characteristics     get more benefit than people with other symptoms or characteristics.   "
241422|NCT01011361|"     On the basis that the clinical consequences of seemingly trivial levels of anemia are     surprisingly severe, this study investigates if hemoglobin concentration accurately     represents the underlying red cell mass in elderly patients with unresolved anemia.   "
241423|NCT01011374|"     This is a prospective, single-center, non-randomized clinical study on the impact of     intravitreally administered ranibizumab (Lucentis) treatment on vision-related functioning     and emotional well-being in subjects with central or branch retinal vein occlusion.   "
241424|NCT01011387|"     Primary objective        -  To assess wound healing and granulation tissue formation when using the NPWT system      Secondary objectives        -  To investigate the pain level at dressing removal        -  To visually check exudate removal        -  To investigate the ease of use for the subject and care giver when using the NPWT system   "
241425|NCT01011400|"     Abnormal enlargement of the clitoris in fetal life may be a sign for different pathologies.     To the investigators knowledge there is no published nomogram of the clitoris size through     gestation and it's assessment is usually subjective. The purpose of this study is to create a     nomogram of clitorial size through gestation by measuring its size in fetuses of different     age in the second and third trimester.   "
241426|NCT01011413|"     Clinical data suggests that the standard dose of the anti-HIV medication, efavirenz (EFV),     could be reduced without compromising its effectiveness. Lower drug doses could have fewer     side effects and would make EFV more affordable. The purpose of this study is to compare the     safety and effectiveness, over 96 weeks, of standard (600mg) versus reduced dose (400mg) EFV     in controlling HIV as part of initial combination antiretroviral therapy.   "
241427|NCT01011426|"     The purpose of this study is to determine whether Bisacodyl, 5 mg usage decreases the     incidence of nausea and abdominal pain after surgery, and also decreases the number of     hospitalization days.   "
241428|NCT01011439|"     The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line     treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously     treated with chemotherapy.   "
241429|NCT01011452|"     Patients presenting to hospital with an acute asthma exacerbation severe enough to require     admission would receive full standard treatment according to British Thoracic Society     guidelines in addition they would be offered the opportunity to take part in the study which     would requite them to take a capsule of either montelukast or placebo.   "
241430|NCT01011465|"     Positive social relationships have consistently been associated with better health, although     the neurobiological underpinnings of these observed effects remain largely unknown. The     overall goal of the proposed work is to explore novel biological pathways that may explain     how social relationships influence health. Recent theorizing suggests that the oxytocin     system may underlie some of the observed beneficial effects. Four hypotheses will be     examined:        1. Oxytocin ameliorates the deleterious neuroendocrine, cardiovascular, and subjective          effects of stress.        2. Oxytocin and social support have similar and additive stress-buffering effects.        3. Effects of oxytocin are evident among younger and older adults.        4. Effects of oxytocin are stronger in women vs men.   "
241431|NCT01011478|"     RATIONALE: Rosuvastatin may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving rosuvastatin after surgery may kill any tumor cells that     remain after surgery. It may also keep polyps from forming or colon cancer from coming back.     It is not yet known whether rosuvastatin is more effective than a placebo in treating colon     cancer that was removed by surgery.      PURPOSE: This randomized phase III trial is studying rosuvastatin to see how well it works     compared with placebo in treating patients with stage I or stage II colon cancer that was     removed by surgery.   "
241432|NCT01011491|"     Portion-controlled meal replacements have been shown to be an effective weight control     strategy in overweight and obese individuals. Thus, the investigators plan to evaluate the     effect of Medifast's 5 & 1 program compared to an food-based diet plan of equal calories on     the following indices: weight loss and maintenance of weight loss, satiety during weight     loss, changes in biochemical markers of inflammation and oxidative stress following weight     loss, and compliance and retention rates.   "
241433|NCT01011504|"     The objective of this study is to determine utilisation patterns in patients receiving     Angiox® in participating European centres. Additionally, through the collection of     descriptive safety and outcomes data, this study will contribute to the Risk Management     strategy for Europe   "
241507|NCT01012479|"     The purpose of this study is to see if Candesartan, once daily (QD), added with     Hydrochlorothiazide may be helpful in treating people with newly diagnosed severe essential     hypertension.   "
242030|NCT01023971|"     The purpose of this study is to determine the changes in macular function during anti-VEGF     treatment for neovascular age-related macular degeneration.   "
241434|NCT01011517|"     The investigators sought to evaluate the effect of muscadine grape seed supplementation on     brachial diameter and flow-mediated vasodilator responses in subjects with, or at risk for     cardiovascular disease.      Methods: In a randomized, double-blind, placebo-controlled crossover trial, 50 adults (25     men, 25 women) with one or more cardiac risk factors were randomized to muscadine grape seed     (MGS) supplement 1300mg daily vs.. placebo for 4 weeks each, with a 4-week washout between     study periods. Resting diameter and endothelial function measured using brachial     flow-mediated dilation (FMD) were determined at the beginning and end of each study period.   "
241435|NCT01011530|"     This is an open-label, multicenter, phase 1, dose escalation study that will evaluate the     safety profile, establish Maximum Tolerated Dose (MTD), and inform the recommended phase 2     dose of MLN4924 as well as evaluate antitumor activity in patients with metastatic melanoma.   "
241436|NCT01011543|"     This is a randomised study that compares different diagnostic approaches for diagnosing     pulmonary tuberculosis in patients suspected of pulmonary tuberculosis in whom the three     classic (non-induced) sputum samples didn't show tuberculous bacillus on direct examination.      The investigators compare the sensibility of induced sputum technique with an endoscopic     approach (CT-scan followed by BAL and fluoroscopy-guided transbronchial biopsies and     eventually sputum collection immediately after the bronchoscopy).      People in high risk population for tuberculosis undergoing screening by chest X-ray or     symptomatic patients will be admitted to the hospital if their chest X-ray shows a suspicion     of active tuberculosis.      According good clinical practice: (non-induced) sputum samples will be taken at admission and     every following morning. If direct examination and PCR of the first three classic sputum     samples are negative: patients will be randomised in two groups with a different diagnostic     approach (induced sputum versus endoscopic approach) The aim of our study is to proof that a     thoroughgoing endoscopic approach has a higher sensibility than an induced sputum in the     diagnosis of pulmonary tuberculosis in patients with a high suspicion of active tuberculosis     on the chest X-ray but with a negative direct examination and/or PCR on three consecutive     normal sputum samples.      The investigators will include 154 patients (based on a statistical analysis for a hypothesis     that the endoscopic approach has a sensibility that's twice the sensibility of the induced     sputum).        -  first arm: 2 consecutive induced sputum using an ultrasonic nebulizer.        -  second arm: CT thorax to evaluate the exact anatomic localisation of the disease          followed by fluoroscopy-guided bronchoscopy for BAL (bronchoalveolar lavage) and          transbronchial biopsies. A sputum sample immediately after the endoscopy will be          collected if possible.   "
241437|NCT01011556|"     The primary purpose of this study is to help answer the following research questions:        1. How teriparatide given using a skin patch (transferred through the skin using the          ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a          needle (pen injector) affects your bone density (how solid or porous your bones are).        2. The safety of the teriparatide skin patch and any side effects that might be associated          with it.   "
241438|NCT01011569|"     There are largely 2 surgical methods for one-level cervical disc disease; cage only and     plate/graft. Even there are many reports about the efficacy of either cage only or     plate/graft, prospective comparative study is few. The object of the present study is to     present design of prospective study and to demonstrate preliminary result.   "
241439|NCT01011582|"     The purpose of this research study is to collect information on problems that patients with     the novel H1N1 influenza and/or the seasonal influenza experience. Novel H1N1 flu is also     called the swine flu. Seasonal influenza is also called the regular flu. The purpose of this     study is to collect information from patients who are infected with either the novel H1N1 or     the seasonal flu and to determine what makes patients critically ill with these infections.     The goal is to develop a registry that will aid investigators in determining specific markers     that lead to development of severe illness in these infections.   "
241440|NCT01011595|"     The gold standard techniques to assess the extent of disease and decide on therapy for     patients with lung cancer consists of cervical mediastinoscopy, which is a surgical procedure     which entails an incision in the neck and the removal of lymph nodes from around the airway.     Endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) are new, non-surgical     techniques that have been available for the past several years and are proving invaluable in     lung cancer evaluation. These techniques are minimally invasive and can be performed without     surgery.      To date, there have been no head-to-head studies on the same group of patients using both the     old and new techniques. The study will consist of a study which compares traditional staging     techniques in lung cancer patients to new, less invasive techniques.      The significance of the proposed project is tremendous. If the new strategies prove to be     equivalent (or superior) to traditional techniques, these techniques will be considered the     new gold-standard tests. This will change the way lung cancer is evaluated. An equivalent or     superior result will also significantly impact on patient care, cost and morbidity due to the     speed, convenience and lack of operating room requirement as well as the lack of general     anesthesia.   "
241441|NCT01011608|"     The objective of this study is to evaluate the effect of nutritional supplementation on the     nutritional and clinical course of patients admitted to the hospital for hip fracture     surgery.   "
241479|NCT01012115|"     In an effort to better understand the interaction between the different mediators, the     investigators propose to examine the time course of mediators, the indexes of organ injury     and the coagulation cascade.   "
241442|NCT01011621|"     Topical corticosteroids are largely used in dermatology. The major problem related to their     use is that the same mechanisms underlying their therapeutic effects (antiinflammatory and     antiproliferative) may lead to adverse events. Conditions sensitive to corticosteroids     require formulations with mild to moderate potency while high-potency corticosteroids era     required in less responsive conditions. The aim of the present study is to compare the safety     and efficacy of prednisolone acetate 0.5% cream (mild-potency non-fluoridated corticosteroid)     versus betamethasone valerate 0.1% cream (high-potency fluoridated corticosteroid) in the     treatment of mild to moderate cortisosensitive dermatosis (atopic dermatitis, contact     dermatitis, seborrheic dermatitis and psoriasis). The study hypothesis is that 0.5%     prednisolone cream will be as effective as 0.1% betamethasone cream and will be an     alternative option to treat corticosensitive dermatosis in body areas where the use of     fluoridated corticosteroids is contraindicated, such as the face.   "
241443|NCT01011634|"     In the United States, the majority of first-trimester surgical abortions are performed in     outpatient clinics that utilize a wide variety of oral and intravenous regimens for pain     control. The specific aim of this study is to evaluate the equivalency of intravenous     moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis     (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg) for     first-trimester surgical abortions. The investigators hypothesize that oral moderate sedation     and intravenous moderate sedation will be equivalent in controlling pain as measured by a     difference of +/- 10 on a 100-point (range 0-100) visual analog pain scale.   "
241508|NCT01012492|"     The primary objective of the study is to determine the safety and tolerability when adding     abatacept to acute Graft versus Host Disease in transplants for malignant diseases using     unrelated donor bone marrow or peripheral blood stem cell grafts.   "
241444|NCT01011647|"     A novel technique in identifying unspecified sleep apnea has been developed. This technique     uses signals typical acquired from a bedside monitor that is found in critical care     environments. Those signals are then processed by a sleep analysis algorithm to provide an     Apnoea Hypopnea Index (AHI) score. This study is intended to determine whether the prevalence     of sleep disordered breathing identification among patients in a Coronary Care Unit (CCU)     using this novel approach is significantly different than using routine techniques.   "
241445|NCT01011660|"     The aim of the study is to investigate the optimized treatment strategy of hypertension, so     as to make more patients to reach the blood pressure goals and to reduce     cardio-cerebrovascular events. Objective and Methods: Patients are eligible for inclusion in     the study if they are essential hypertension, 50-79 years of age with at least one     cardiovascular risk factor and sign the informed consent forms. This project is a     multi-centre, prospective randomized,，openlabel blind-endpoint evaluation controlled (PROBE)     trial. 12000 patients will be randomly assigned to either of low-dose Amlodipine+Telmisartan     group or Amlodipine+ diuretics group. Among those patients with serum cholesterol between     4.0-6.1mmol/L, they will be also randomized into small dose of statin-based regimen or     standard management regimen; Patients will also randomly assigned to intensive lifestyle     intervention group or standard intervention group according to the community area where the     patients in.   "
241446|NCT01011673|"     Occasionally, episodic tension-type headache may be severe enough to require an emergency     department (ED) visit. The purpose of this study is to compare two commonly used medications     to see which is better for tension type headache. Patients who present to the ED with an     acute tension-type headache requiring treatment with injectable medication will be randomized     to metoclopramide or ketorolac.   "
241447|NCT01011686|"     Fecal incontinence affects 18.4% adults in the community and greatly impacts quality of life.     There's a problem like inconvenience, pain or allergic response in many therapeutic methods     such as a surgical operation or material injection. ANT-SM is autologous adipose-derived stem     cell, and so, expect of no immune responses. In this study, patients are given injection of     ANT-AM in anal sphincter and followed for 4 weeks to test the safety.   "
241448|NCT01011699|"     The comparison between nicotinamide and sevelamer aims to demonstrate, in chronic     hemodialysed patients, the non-inferiority of nicotinamide in terms of control of the     phosphatemia. Secondary objectives is to compare the two treatments in terms of efficiency in     other biological parameters, vascular calcification and bone mass loss and on the clinical     and biological tolerance and finally to explore the roles of metabolites of nicotinamide.   "
241449|NCT01011712|"     Background:        -  Infections caused by viruses are common causes of illnesses: the common cold, many ear          infections, sore throats, chicken pox, and the flu are caused by different viruses.          Usually, these illnesses last only few days or, at most, a few weeks. Some virus          infections like influenza are cleared from the body, and others such as the chicken pox          virus remain in the body in an inactive state. However, some people may become quite ill          when they are infected with a particular virus, possibly because part of their immune          system does not respond properly to fight the virus.        -  Researchers have discovered some reasons why a person may not be able to clear an          infection caused by a virus. Some persons have changes in the genes that involve the          immune system that result in the inability to properly control infection with a          particular virus. Identifying changes in genes that involve the immune system should          help scientists better understand how the immune system works to protect people from          infection and may help develop new therapies.      Objectives:        -  To study possible immune defects that may be linked to a particular severe viral          infection.        -  To determine if identified immune defects are genetic in origin.      Eligibility:        -  Individuals of any age who have or have had a diagnosis of a virus infection that          physicians consider to be unusually severe, prolonged, or difficult to treat.        -  Relatives of the participants with a severe viral infection may also participate in the          study. We will use their blood and/or skin specimens to try to determine if identified          immune defects are hereditary.      Design:        -  Prior to the study, the participant's doctor will give researchers the details of the          infection, along with medical records for review. Eligible participants will be invited          to the NIH Clinical Center for a full evaluation as an outpatient or inpatient.        -  At the Clinical Center, participants will be treated with the best available therapy for          the particular viral infection, and researchers will monitor how the infection responds          to the treatment.        -  Researchers will take intermittent blood samples and conduct other tests (such as skin          biopsies) to evaluate the immune system. - During and after the illness, researchers          will conduct follow-up visits to determine the course of infection and response to          therapy.   "
241450|NCT01011725|"     This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic     efficacy of MK0773 in healthy postmenopausal women.   "
241451|NCT01011738|"     This observational, non-interventional cohort study will evaluate predictors of response in     patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and     safety parameters will also be evaluated. Patients included in the study will be followed for     the duration of their treatment and for up to 3 years thereafter.   "
241452|NCT01011751|"     The purpose of this study is to compare the efficacy of three drugs (cyproterone acetate,     medroxyprogesterone acetate and venlafaxine) in the treatment of hot flushes caused by     leuprorelin LP 11.25 milligram (mg) in participants suffering from prostate cancer.   "
241453|NCT01011764|"     The goal of this study is to compare the effects of two separate, manualized group     interventions designed to improve social outcomes for young children with autism. The first     type of group intervention utilizes a social skill curriculum delivered to a small group of     children with autism at their school. This type of group will be referred to as the Skills     group (SKILLS intervention). The other intervention delivers a social engagement curriculum     at the children's school site and includes children with autism and typically developing     peers, from the same school. This type of group will be referred to as the School Engagement     Group (ENGAGE intervention).   "
241454|NCT01011777|"     The aim of this study is to study safety, tolerability and efficacy of muscle derived cell     (MDC) therapy in children with bladder exstrophy epispadias induced urinary incontinence.   "
241455|NCT01011790|"     The purpose of this study is to assess a novel meditation program which is biofeedback     reinforced (Healing Rhythms™) as a means to improving stress management in a population of     nurses practicing in the hospital setting.   "
241537|NCT01012869|"     Chronically total occlusions (CTO) are difficult to treat and have high risk for restenosis.     Although everolimus-eluting stents (EES) [(Xience, Abbott Vascular) or Promus (Boston     Scientific)] are very promising for the treatment of CTOs due to their low late loss and     excellent deliverability, there are currently no published data on EES implantation in CTOs.      The specific aim of this proposal is to examine the 8-month incidence of binary angiographic     in-stent restenosis (defined as a stenosis of > 50% of the minimum lumen diameter of the     target stent) after implantation of the EES in CTO.      It is the investigators hypothesis that EES-treated CTO lesions will have ≤ 20% 8-month     in-stent binary angiographic restenosis rate.   "
241456|NCT01011803|"     Swallowing implies the appropriate use and sufficient function of specific muscles that are     also used in speech. Theoretically, if these muscles are functionally affected then phonation     and vocalization should be impaired, as well. The purpose of this study is to examine the     relationship between functions of speech and risk of aspiration as defined by swallowing     function, and to investigate the diagnostic potential that functions of speech may have in     predicting the risk of aspiration. This could allow for earlier stratification of ICU     patients for aspiration risks. Aspiration pneumonia has been reported in more than 20% of     patients with health care-associated pneumonia. There are multiple tools to assess for risk     of aspiration in the ICU, yet these are time consuming, often delayed and involve advanced     testing that is performed by a certified speech-language pathologist and/or radiologist. A     novel 3-step phonetic evaluation was created and will be implemented on ICU patients at risk     for aspiration, and the results will be correlated to the standard swallowing tests. If     strong correlation is found in this pilot study, then formal clinical trial will follow to     confirm that the simple bed-side phonetic evaluation could allow for earlier identification     of patients at risk for aspiration, and more efficient management relative to time and     resources utilization.   "
241457|NCT01011816|"     The purpose of this investigation is to establish the safety and efficacy of the Biostat     System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal     disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group     receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another     group receiving a preservative-free normal saline control delivered with the Biostat Delivery     Device.   "
241458|NCT01011829|"     Methamphetamine (MA) abuse is the fastest growing drug problem in the United States and is     responsible for significant public health complications, including HIV infection. As a result     effective treatments for MA dependence are urgently needed. There are currently no     efficacious medications for MA dependence, although results from preliminary randomized     trials of bupropion for MA dependence found bupropion to be more effective than placebo, but     only among subgroups of participants, including those with lower frequency of MA use at     baseline. A growing body of preclinical and clinical studies suggest that cholinergic     mechanisms play an important role in the neurobiology of MA and other stimulant dependence,     such as nicotine dependence. Mechanistically, cholinergic medications may alleviate     MA-associated cognitive dysfunction, thereby improving outcomes of treatment for MA     dependence. Varenicline is a partial agonist at α4β2 nicotinic receptors and a full agonist     at α7 nicotinic receptors that has been approved as an anti-cigarette smoking medication. In     order to assess the potential efficacy of varenicline for methamphetamine dependence, we will     perform a clinical trial to assess if varenicline compared to placebo results in greater:        1. reductions in methamphetamine use;        2. treatment retention;   "
241459|NCT01011842|"     To determine if a new optical system that can track a patient's movement during treatment can     be used to measure motion and allow for motion adjustments in order to decrease the amount of     healthy tissue that receives radiation without limiting our ability to cure cancers using     radiation.   "
241460|NCT01011855|"     The purpose of this study is to compare three radiant warmer beds that contain different     computer heating software and different bed styles. Radiant warmers are used in many neonatal     intensive care units (NICU) to provide heat to infants to help regulate an infant's     temperature. It is common for babies to require care on an open bed that provides heat to the     baby according to the baby's needs and at the same time allows easy access to the baby for     care and necessary procedures. There are different styles of beds, each with unique computer     software that can guide how a bed's heater output is automatically adjusted according to a     baby's temperature needs. It is unknown which style of bed or method of heating might be     best. This study seeks to evaluate infant responses to three different types of radiant     warmer beds.   "
241461|NCT01011868|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in     combination with basal insulin in patients with type 2 diabetes mellitus with insufficient     glycaemic control.   "
241462|NCT01011881|"     The purpose of this study is to determine pleural level of procalcitonin in differents     situations of pleuritis.   "
241478|NCT01012102|"     To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with     Montanide® ISA 51 VG with regard to immunological efficacy.      The primary target variable is the immune response as assessed by ELISPOT before and until     week 17 after vaccination with EMD 640744 in Montanide® ISA 51 VG.   "
241463|NCT01011894|"     The purpose of this study is to:      Determine the likelihood that lenalidomide will adequately control the disease for at least     one year.      Lenalidomide is a drug that alters the immune system and it may also interfere with the     development of tiny blood vessels that help support tumor growth. Therefore, in theory, it     may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and     Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome     (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have     received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being     tested in a variety of cancer conditions.      In this case it is considered experimental. The lenalidomide being administered in this study     is not a commercially marketed product. Although it is expected to be very similar in safety     and activity to the commercially marketed drug, it is possible that some differences may     exist. Because this is not a commercially marketed drug, lenalidomide can only be     administered to patients enrolled in this clinical trial and may only be administered under     the direction of physicians who are investigators in this clinical trial.   "
241464|NCT01011907|"     Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which     either varenicline (twice daily) or placebo will be administered over a 12 week study period     to examine genetic influences on treatment response to varenicline for reduction of hazardous     drinking.   "
241538|NCT01012882|"     The purpose of this study is to evaluate the efficacy and safety of specific sublingual     immunotherapy (SLIT) with allergen extracts in patients suffering from seasonal allergic     rhinitis .   "
241539|NCT01012895|"     The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination     alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in     the treatment of Hepatitis C in patients who have not responded to prior therapy.   "
242045|NCT01024166|"     The goal of this research study is to learn if palliative care patients or caregivers, and     palliative care physicians or nurses can use a computer program designed to provide     information about the symptoms and overall health of cancer patients.   "
241465|NCT01011920|"     This is a multicenter open label randomized phase II trial.      Enrolled Primary Central Nervous System Lymphoma (PCNSL) patients will be stratified     according to the IELSG score and randomized to receive one of the follows as primary     chemotherapy:        -  Arm A: Methotrexate (MTX) + Cytarabine (Ara-C)        -  Arm B: MTX + Ara-C + rituximab        -  Arm C: MTX + Ara-C + rituximab + thiotepa.      Chemotherapy will be administered every three weeks. The maximum number of chemotherapy     induction courses will be 4. Patients in Stable Disease (SD) or better after two courses will     receive two more courses of the same primary chemotherapy regimen. Stem-cells harvest will be     performed in the three arms after the second course. After 4 courses response assessment will     be performed.      Patients who will not achieve SD or better after the 4th course, as well as those who will     experience Progressive Disease (PD) at any time and those who will not achieve a sufficient     stem cell harvest, will receive Whole Brain Radiation Therapy (WBRT) 36-40 Gy +/- tumor bed     boost of 9 Gy.      Patients who will achieve SD or better after the 4th course will be stratified according to     objective response to primary chemotherapy and to primary chemotherapy regimen and randomly     allocated to receive as consolidation therapy one of the follows:        -  Arm D: WBRT 36 Gy +/- boost 9 Gy        -  Arm E: Carmustine (BCNU) + Thiotepa + Autologous Peripheral Blood Stem Cell Transplant          (APBSCT) Patients in Complete Response (CR) after WBRT or APBSCT will remain in          follow-up. Patients who will not achieve a CR after WBRT will be managed according to          physician's preferences. Patients who will not achieve a CR after APBSCT will be          referred to WBRT.   "
241466|NCT01011933|"     This phase II trial is studying how well selumetinib works in treating patients with     recurrent or persistent endometrial cancer that has come back or is persistent. Selumetinib     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
241467|NCT01011946|"     The purpose of this study is to determine if PEM scan can improve axillary lymph node staging     by assessing if they are involved by cancer. Your doctor may refer you for a PEM scan, PEM     stands for positron emission mammography, a relatively new and advanced application of     positron emission tomography or PET scanning. For decades, PET has helped doctors diagnose     and treat disease.   "
241468|NCT01011959|"     This is a randomized study of the safety and tolerability of multiple doses of REGN88 in     rheumatoid arthritis patients who are receiving treatment with methotrexate.   "
241469|NCT01011972|"     XMT-1107 has been shown in nonclinical studies to slow the growth of tumors. These effects     may result from blocking the growth of new blood vessels that help the tumors survive.   "
241470|NCT01011985|"     To determine if the type of hemodialysis vascular access correlates with markers of     inflammation, namely C-reactive protein and interleukin-6, and with both access and patient     survival in the end stage renal disease population.   "
241471|NCT01011998|"     The aim of this study is to test the effect of the combination of valproate in combination     with imatinib with an aim of achieving a maximal molecular response as the primary goal.   "
241472|NCT01012011|"     This surveillance are to identify problems/questions regarding adverse events, factors that     are considered to affect on safety and efficacy in the clinical practice of using Nexavar   "
241473|NCT01012037|"     The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg     twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as     add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient     glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily     compared to 5 mg once daily and each treatment's superiority over placebo.   "
241474|NCT01012050|"     Despite the physiologic and clinical effects provided by coupling nebulization with     noninvasive ventilation in asthma exacerbation, there are few and controversial studies     reported in the literature.   "
241475|NCT01012063|"     The object of this study is to evaluate whether low dose intravenous iron and erythropoietin     (Epo) can decrease transfusion requirement after the bilateral TKRA.   "
241476|NCT01012076|"     Eighty parent-child dyads will be recruited and randomly assigned to either the experimental     intervention or an active control condition. Subjects assigned to the experimental group will     participate in 12 home-based intervention sessions.   "
241480|NCT01012128|"     Preterm infants will have their body temperature measured by three different devices in order     to evaluate whether the newest device, a temporal artery scanning thermometer, is accurate     for patients in the preterm period.   "
241481|NCT01012141|"     RATIONALE : Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary     supplements, such as phytochemicals, may stop or delay the development of prostate cancer.   "
241482|NCT01012154|"     This study aims to create an atlas based on the preliminary experience of the first     feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used     during neurosurgery to provide in vivo histology that enables documentation of neurological     pathology across a range of tumor ypes and grades, suitable for comparison with traditional     histopathology from site‐matched biopsies.   "
241540|NCT01012908|"     The primary objective of this clinical trial is to demonstrate non-inferiority clinical     development of pancreatic enzymes from Laboratory Bergamo (Norzyme ®) in relation to     pancreatic enzymes from Solvay Pharmaceuticals (Creon ®), by comparing the average amount of     lipids in the feces of 72 hours after 14 days of treatment with each drug.   "
241483|NCT01012167|"     The project is designed to address the following two primary aims:        1. To determine whether adjunctive oxytocin is superior to placebo for the treatment of          persistent negative symptoms, as measured by the SANS total score, in people with          schizophrenia.        2. To determine whether adjunctive Galantamine is superior to placebo for the treatment of          cognitive impairments, as measured by improvement on a composite neurocognitive score in          people with schizophrenia.      The investigators will also address the following secondary aims:        1. To determine whether people with schizophrenia treated with adjunctive oxytocin,          compared to placebo, will show greater improvement on markers of negative symptom          liability including: social affiliation, facial affect recognition, olfactory          discrimination, initiation of smooth pursuit and latency of internally-driven saccades.        2. To determine whether people with schizophrenia treated with adjunctive Galantamine,          compared to placebo, will show greater improvement on markers of cognitive impairment          liability including: predictive pursuit, P50 sensory gating and visual-spatial working          memory.      The investigators will address the following exploratory aims:        1. To determine whether changes in markers of negative symptom liability are correlated          with changes in SANS total score.        2. To determine whether changes in markers of cognitive impairment liability are correlated          with changes in the composite neurocognitive score.        3. To determine the response to oxytocin of all cognition domains assessed by the MATRICS          battery, and to determine the response to Galantamine of all cognition domains assessed          by the MATRICS, which are not included in the primary neurocognitive outcome score.        4. To determine whether there is a differential response of oxytocin and Galantamine on the          SANS total score, composite neurocognitive score, and with the phenotypic measures of          negative symptom and cognitive impairment liability.        5. To determine whether oxytocin and Galantamine are associated with:             -  adverse effects on positive or depressive symptoms;             -  adverse effects on motor symptoms;             -  adverse effects on laboratory and EKG measures;             -  increased occurrence of side effects;             -  social interest that is independent of sexual desire.   "
241484|NCT01012180|"     Background:        -  Bipolar disorder is a common mood disorder that affects 1% to 2% of the population.          Individuals with bipolar disorder tend to have periods of mania that are characterized          by extra energy, very poor judgment or unrealistic beliefs about their thoughts and          abilities, and an inability to complete thoughts and tasks; as well as major depressive          episodes. The range and frequency of symptoms in affected individuals can vary greatly.          Most individuals have cyclical symptoms and spend more time in a normal mood state than          in an overtly symptomatic state.        -  Relatives of individuals with bipolar disorder have an increased risk for bipolar          disorder and other mood disorders. Currently, risk assessment for recurrence of a mood          disorder is based on family and medical histories; genetic testing has not proved          particularly useful to date for assessing risks of a mood disorder.        -  Despite its prevalence, there is limited research on coping with bipolar illness. No          published studies have examined adaptation to living with bipolar disorder or risk for          bipolar disorder. More specifically, though a positive family history is the most          important known risk factor for bipolar disorder, there are no published studies about          response to the threat of future illness onset in children, risk modification efforts          undertaken by affected parents, or coping with the risk for illness in children.      Objectives:        -  To examine parents appraisals of the impact and cause of bipolar disorder, and the          association with their perceived risk for bipolar illness in their child and how they          cope with their perception of risk to their child.        -  To assess whether parents adaptation to their own illness is associated with coping with          perceived risk to their child.        -  To describe parents coping strategies related to perceived risk in their children.      Eligibility:      - Men and women at least 18 years of age who have been diagnosed with bipolar disorder and     who have at least one biological child (30 years of age or younger). Participants must be a     primary caregiver for their children.      Design:        -  Participants in this study will take an online survey and answer questions about disease          perceptions, coping strategies, and adapting to a diagnosis of bipolar disorder,          addressing issues such as the following:        -  Assessing the threat of bipolar disorder and coping with one s own illness.        -  Optimism/pessimism of the individual coping with the illness.        -  Perception of risk to a child, and coping with the perceived risk.        -  Data from this study will not be shared with the participants/respondents.   "
241485|NCT01012193|"     The purpose of this study is to determine the impact of adjunctive cilostazol versus high     maintenance-dose clopidogrel on platelet inhibition in carriers and non-carriers of the     loss-of-function CYP2C19 mutant allele.   "
241486|NCT01012206|"     The aim is to investigate the development of overweight and obesity from infancy to school     age, and to evaluate an intervention to prevent further development of overweight and obesity     among children.      A follow-up study will be conducted on 267 children and will allow comparison between     children that developed overweight with the ones who did not. Subjects will be requited at 10     years of age from a previous project. These children have been studied when they were 6-18     months old and a follow-up was conducted at 4 years of age. Sixteen percent of the children     were overweight at 4 years of age and retrospective data of e.g. food intake, blood lipids     and anthropometric measurements exists. In the present follow-up data regarding food and     physical activity habits, anthropometric measurements and blood samples of e.g. blood lipids,     IGF1 will be collected.      An intervention study will be conducted on 80-120 overweight children that will be randomized     into one intervention and one control group. An intervention during two years will encourage     long term healthy habits regarding diet and physical activity through group meetings and     supervision. Information about food habits will be collected through questionnaires,     interviews and diaries. Measurement of physical activity and energy expenditure will be made     with Sense Wear and double labeled water, and will be used to validate reported food intake.     Further, anthropometric measurements and blood samples will be collected.   "
241487|NCT01012219|"     This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of     laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in     combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3     will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and     laropiprant components of Tredaptive.   "
241488|NCT01012232|"     In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee     arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus     injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high     concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at     rest and with mobilization for 2 hours after injections.   "
241489|NCT01012245|"     Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom     in Germany and to assess the long-term efficacy and tolerability under routine conditions.     Data were entered into an electronic case report form.   "
241582|NCT01019902|"     This study aims to determine how maternal Fe status influences placental and neonatal Fe     status in pregnant adolescents and to assess the impact of the Fe endowment of birth on     functional outcomes as assessed by auditory brainstem responses within 48 h of delivery in     neonates born to these adolescents.   "
241490|NCT01012258|"     Primary objective: to assess the antitumor activity and safety profile of cetuximab when     given in combination with radiotherapy (RT) for the treatment of locally advanced squamous     cell carcinoma of the head and neck (SCCHN) in Chinese subjects.      Secondary objective: to assess the pharmacokinetic (PK) profile and immunogenicity of     cetuximab in Chinese subjects.      Further objective: to identify for cetuximab potential predictive biomarkers of response and     safety.   "
241491|NCT01012271|"     The purpose of our study is to evaluate the diagnostic accuracy of MR arthrography of the     wrist at 1.5, 3.0, and 7.0T with wrist arthroscopy as reference standard.   "
241492|NCT01012284|"     The purpose of this study is to assess the pharmacokinetics (what the body does to the     medication), safety and tolerability of TMC207 and its N-monodesmethyl metabolite (M2) in     healthy participants and in patients with moderate hepatic impairment after administration of     a single 400 mg dose of TMC207.   "
241541|NCT01012921|"     The aim of the study is to test in a randomized comparative study the performance of     Straumann® MembraGel (PEG Membrane) to act as a barrier for guided bone regeneration compared     to that of a standard collagen membrane (BioGide®) in the bone regeneration around Straumann®     SLActive bone level titanium implants.      Furthermore the clinical evaluation and comparison of complementary parameters describing the     bony and soft tissue environments at the surgical sites during the study period to evaluate     effectiveness and performance of the membranes.   "
241493|NCT01012297|"     This randomized phase III trial is studying gemcitabine hydrochloride, docetaxel, and     bevacizumab to see how well they work compared with gemcitabine hydrochloride, docetaxel, and     a placebo in treating patients with advanced or recurrent uterine leiomyosarcoma. Drugs used     in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether     gemcitabine hydrochloride and docetaxel are more effective when given with or without     bevacizumab in treating uterine leiomyosarcoma.   "
241494|NCT01012310|"     The purpose of this study is to determine the safety and toleration of single and multiple     doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083     and its metabolites, following single and multiple dose administration in healthy male and/or     female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in     metabolism of other drugs following multiple dosing).   "
241495|NCT01012323|"     The purpose of this study was to determine the efficacy of NewGam in preventing serious     bacterial infections and to determine the pharmacokinetic profile of NewGam. The safety of     NewGam and its effect on quality of life were also evaluated.   "
241496|NCT01012336|"     The current recommended guideline for patients receiving moderately emetogenic chemotherapy     (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of     chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving     MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been     observed. Hence, there is clearly a need for more effective prevention of CINV in patients     receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to     these symptoms. Therefore the investigators designed a study with the objective to evaluate     if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in     ovarian carcinoma patients treated with taxane/carboplatin.   "
241497|NCT01012349|"     This study aims is to evaluate, two hours after a single administration, the rate of     sustained response produced by the association Geolab consisting of acetylsalicylic acid,     sodium bicarbonate and anhydrous citric acid - oral powder, with the active comparator     acetylsalicylic acid (Aspirin ® -- Bayer) - a simple tablet for the treatment of acute pain     in patients with mild to moderate CTTE, using for both the visual analog scale pain - VAS.   "
241498|NCT01012362|"     This is a Phase I study; dose escalating the combination of pazopanib when taken daily and     ixabepilone when administered on day 1 of a 3 week treatment course.   "
241499|NCT01012375|"     The purpose of this study is to determine whether 2 weeks of treatment with AZD1446 compared     to placebo improves ADHD symptoms and is well tolerated.   "
241500|NCT01012388|"     Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and     hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving     nasolabial fold treatment with Radiesse® Injectable Dermal Filler   "
241501|NCT01012401|"     This study will examine the potential for an Interactive Cancer Communication System (ICCS)     to impact not only psychosocial outcomes such as quality of life but also length of survival     in an advanced stage lung cancer population. Two hypotheses will be tested: the Comprehensive     Health Enhancement Support System- Lung Cancer (CHESS- LC) will significantly improve patient     quality of life and length of overall survival as compared to a usual care control group.   "
241502|NCT01012414|"     The purpose of this study is to determine if vitamin D supplementation changes the results of     certain tests associated with inflammation in the body using an oral, synthetic form of     vitamin D called paricalcitol.   "
241503|NCT01012427|"     This study is being done to test how effective cryoablation is in killing cancer cells.     Cryoablation uses freezing temperatures to treat cancer. Cryoablation works by creating     freezing temperatures within a needle probe. When this probe is inserted into a cancer, the     freezing temperatures are used to try and kill the cancer. Unfortunately, the investigators     don't know how well cryoablation works at destroying the cancer. This study will allow us to     check to see how well cryoablation works for kidney cancers. After the investigators destroy     the kidney cancers using cryoablation, the investigators will followup with you every 5-7     months to make sure the cryoablation worked and that the cancer was destroyed.   "
241504|NCT01012440|"     The purpose of this study is:        1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to          neoadjuvant chemotherapy in patients with breast cancer?        2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care          bilateral breast MRI.   "
241505|NCT01012453|"     Objectives and perspective:        1. To estimate the prevalence of hand eczema in a cohort of health care workers and assess          exposures in the hospital environment that can lead to hand eczema . To investigate the          knowledge of skin protection among health care workers.        2. To classify subtypes of hand eczema, assess severity of hand eczema and quality of life          in health care workers with hand eczema        3. To evaluate the effect of a combination of classification of hand eczema and individual          work-related counseling in skin protective behavior.      The overall perspective of the trial is to develop new strategies for prevention of     occupational hand eczema in health care workers.      Hypotheses:        -  Irritant contact dermatitis is more common than allergic contact dermatitis.        -  The combination of precise classification (subtyping of HE) and individual counseling          will have a positive impact on the prognosis of hand eczema.        -  The positive impact on the prognosis of hand eczema will have a positive impact on          quality of life (QoL).        -  The knowledge of protective behavior will increase.        -  Education in a skin care program will have a positive impact on skin protective          behavior.   "
241506|NCT01012466|"     The purpose of this study is to find out if negative thoughts have an effect on pain     experienced during labor and how labor progresses. Other studies have shown that women who     experience intense pain in the earliest stages of labor have a higher risk of complications.     The investigators want to know if negative thoughts can predict this outcome.   "
241509|NCT01012505|"     Mammalian fetal sensory development comes in an invariant series, with the     tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to     stimulation, implicating the importance of these foundational sensory systems for later     development. Olfaction is essential for neonatal behavioral adaptation in many mammals,     including humans. Experiments show that newborns recognize, and are soothed by, the smell of     amniotic fluid. Provision of the mother's smell with breast pads, handkerchiefs she has worn,     breast milk on a cotton ball or cotton applicator, or other means of providing odor and taste     input can facilitate recognition by the infant's mother at a later time and does not appear     to be detrimental to the stability of the infant.      Provision of the odor and taste of the mother's milk has been shown to facilitate the     infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation     for oral feeding. Using 24 hour monitor analysis and cortisol saliva measurements, we will     provide quantitive analysis to the effect of smell.   "
241510|NCT01012518|"     The purpose of this study is to compare the feasibility, safety, efficacy and ease of     performance of a video-assisted PCT (via an endotracheal tube embedded with a mini     video-camera) with the standard (blind) PCT technique.   "
241511|NCT01012531|"     The objective of this study is to assess the efficacy and safety of cluster immunotherapy     with highly polymerized allergen extracts.   "
241512|NCT01012544|"     Recent studies have demonstrated a marked interindividual variability of clopidogrel's     capacity to inhibit platelet aggregation with a substantial proportion (11-34%) of the     patients considered non-responders to clopidogrel treatment. Variable intestinal absorption     is suggested to contribute to the inconsistencies in response to clopidogrel. However, little     is known about intestinal absorption in subjects who had suffered from a stent thrombosis.     The MAPCAT-study has been designed to investigate whether plasma pharmacokinetics     (represented by Cmax, Tmax and the AUC) after a 600 mg loading dose are significantly     different between subjects who have suffered a stent thrombosis and subjects who have not     suffered a stent thrombosis.   "
241513|NCT01012557|"     Pregnant women are at particular risk during the imminent H1N1v influenza pandemic. The new     H1N1v virus requires urgent political and medical decisions on vaccination strategies in     order to minimize severe disease and death from this pandemic. However, there is a lack of     evidence to build such decisions upon. A vaccine will be provided in the fourth quarter of     2009, but there is little knowledge on the immunogenicity. Particularly its clinical     effectiveness and duration of immunity in pregnant women and their newborn infants is     unknown. Therefore, it will be important to study the optimal vaccination regimens with     respect to dosing and use of adjuvant to decide future health policies on vaccination of     pregnant women. We have a unique possibility to study these aspects of H1N1v infection in     pregnant women in our ongoing unselected, prospective, birth-cohort study recruiting 800     pregnant mothers between Q1- 2009 and Q4-2010. Pregnant women from East-Denmark are being     enrolled during the 2nd trimester and their infant will undergo a close clinical follow-up.     The H1N1v pandemic is expected to reach Denmark Q4-2009. The timing of this enrollment and     the imminent pandemic allows for an experiment of nature whereby the first half of the     mothers completes pregnancy before the H1N1v pandemic. The other half of this cohort will be     pregnant while H1N1v is prevalent in the community and will require H1N1v vaccination. The     aim of this randomized, controlled, trial is to compare and evaluate the dose-related immune     protection conferred by vaccine and adjuvant (Novartis vaccine Focetria) in pregnant women     and non-pregnant women. In addition the protocol will assess the passive immunity conferred     to the newborn from these vaccine regimes. The study will provide evidence-based guidance for     health policies on vaccination for the population of pregnant women during future H1N1v     pandemics.   "
241514|NCT01012570|"     The investigators will study the effect of Adalimumab on the bone microstructure.        -  Trial with medicinal product   "
241515|NCT01012583|"     BACKGROUND Treatment of coronary atherosclerotic disease has been significantly advanced by     interventional cardiology, and the advent of coronary arterial stents. In comparison to     angioplasty alone, stents have reduced the incidence of angiographic as well as clinical     restenosis, the recurrence of angina, the need for coronary arterial bypass graft (CABG)     surgery, repeat revascularization and the occurrence of major adverse cardiac events     (MACE).However the long-term success of this therapy has been limited by the occurrence of     in-stent restenosis. Despite the effectiveness of intracoronary stents in maintaining a     larger luminal diameter, as compared to angioplasty alone, in-stent restenosis occurs within     6 to 9 months after stent placement in 15% to 35% of patients. While stents can reduce     restenosis by blocking vascular recoil and remodeling, mechanical intervention alone has been     incapable of treating this biological problem of neointimal hyperplasia, particularly in the     subset of patients with diabetes, long lesions or small vessel disease.Drug-eluting stents     (DES) were developed as a viable method for focused delivery of anti-restenosis compounds to     target lesions for the reduction of restenosis. Of the DES available and with the results of     up to six (6) years clinical follow-up, the sirolimus-eluting stent (SES) has become the     current gold standard for stent implantation. With the advent of using DES to treat complex     lesions such as longer lesions requiring the use of multiple stents and the use in     bifurcation lesions, the risk of stent thrombosis has increase.Late stent thrombosis has also     been reported following DES implantation.Long term treatment with dual anti-platelet therapy     following stent implantation has become the solution used to counteract the risk of stent     thrombosis, this solution does not come without it's own risks and is an expensive therapy.     Another specific problem of DES is delayed endothelization, and this may be and attributing     factor in prolonging the period of thrombotic risk as shown by pathological findings at     autopsy following SES implantation. These examinations have shown that even after 16 months,     neointimal healing is still incomplete with approximately 20% of stent struts being found     uncovered. Questions have arose that the problems of late thrombosis and delayed     endothelization of stent struts with DES could be the result of the permanent polymer that is     used as the bonding agent for the anti-restenosis compounds to the stents.Intravascular     Ultrasound (IVUS) along with angiography has been the techniques used to gain data on DES to     this point. Angiography is a 2 dimensional tool that gives a view of the vessel and IVUS     gives a more 3 dimensional view of the vessel. IVUS does have its limitations, as stent     struts are reflectors of sonic waves, shadowing around and behind the struts occurs. IVUS is     also limited in detecting malapposition of the struts to the vessel wall especially if the     area between the vessel wall and the strut in very small.      RATIONALE Optical Coherence Tomography (OCT) is an optical analogue of IVUS that uses an     infrared light source and measures the backscatter of the light. With this technique a higher     level of resolution compared with IVUS has been reported.OCT has been reported as being able     to visualize and detect atherosclerotic plaques and assess more accurately strut     malapposition and the presence or thickness of neointimal hyperplasia as compared to IVUS.     With the question of delayed endothelization due to the permanent polymer being a probable     risk for late stent thrombosis, it is felt that OCT post stent implantation may give a more     accurate assessment of stent strut endothelial coverage.      This study is designed to compare the intimal hyperplasia following implantation of the Excel     DES with a biodegradable polymer vs. the Cypher DES with a permanent polymer using OCT.   "
241516|NCT01012596|"     The Creighton Model (CrM) FertilityCare System is a natural family planning method that     teaches couples to recognize and chart the signs of fertility and infertility in the woman's     cycle and to use that knowledge to either achieve or avoid a pregnancy. The method is     natural, safe and effective, and it helps the couple understand their fertility. Trained     practitioners at FertilityCare Centers teach the Creighton Model across the country,     internationally and long distance.      Several FertilityCare Centers and the University of Utah are conducting a study to evaluate     the effectiveness of the Creighton Model (CrM) for new and return users wanting to avoid     pregnancy. While past studies have shown that the Creighton Model is a highly effective     method, this study will use new ways to measure how well it works. This is important because     the knowledge gained will improve comparisons between the Creighton Model and other family     planning methods. The study will also explore intentions and behaviors of couples to avoid or     achieve a pregnancy.      The investigators hypothesize that for the CrM the pregnancy rate during perfect use to avoid     pregnancy will be about 1% and the behaviorally determined avoiding-related pregnancy rate     for the CrM will be about 6%. The investigators will also evaluate the pregnancy rate during     typical use without a previously stated intention to conceive (in CrM terms, a mixture of     avoiding and achieving-related behavior).   "
241583|NCT01019915|"     Heart failure patients with left bundle branch block have a poor prognosis. Biventricular     pacing which synchronize the heart pump action is associated with improved functional     capacity. This study aims to evaluate the basic changes in skeletal muscle functioning after     a period of biventricular pacing in 21 patients with heart failure.   "
241517|NCT01012609|"     Standard treatment for patients with diffuse pontine tumors is radiation therapy, but less     than 10% of patients are cured. Adding standard chemotherapy has not improved the cure rate.      Standard treatment for high-grade astrocytomas is surgery and radiation. The surgeon removes     as much of the tumor as she or he can. Radiation after that tries to kill any cancer cells     that are left. Some patients also get chemotherapy. These are anti-cancer drugs. They can be     given during or after radiation. Current standard treatments do not cure many patients.      In this study the doctors are adding a new medication called cetuximab to the treatment and     will also use a chemotherapy medication (irinotecan) that has been promising for patients     treated for recurrent disease.   "
241518|NCT01012622|"     The purpose of this study is to evaluate the safety and efficacy of Osmotic Release Oral     System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder     (ADHD).   "
241519|NCT01012635|"     This study compares five different procedures to see how they affect pain and brain activity.     The procedures include neurofeedback, self-hypnosis training, meditation, and two different     levels of transcranial direct current stimulation (tDCS). Subjects will be compensated for     their time.   "
241520|NCT01012648|"     RCT colloids versus cristalloids only in severe burn victims.        -  Trial with medicinal product   "
241521|NCT01012661|"     To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler     mixed with lidocaine.   "
241522|NCT01012674|"     The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering     from carotid or vertebral arterial disease.   "
241523|NCT01012687|"     The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg     tablets under fasting conditions.   "
241524|NCT01012700|"     Vaccines induce protective immunity against numerous infectious diseases. However, current     vaccines have limited efficacy against challenging infections like tuberculosis, malaria and     HIV. Protein vaccines are safe but, typically, they induce weak T cell immunity when     administered alone. Therefore, special attention is being given to adjuvants, which are     enhancers of immunity, that mature antigen presenting immunostimulatory dendritic cells     (DCs). Our goal is to study in humans the mechanism whereby synthetic adjuvants, acting on     defined pattern recognition receptors (PRR), enhance T and B cell immunity. In preclinical     studies, the investigators' laboratory has found in mice that poly IC and its analog poly     ICLC are superior adjuvants for T cell mediated immunity relative to other agonists for PRR.     In this study the investigators propose to study the safety and the innate immune responses     to poly ICLC in multiple blood cell types, including three different subsets of DCs when     administered subcutaneously or intranasally to healthy volunteers. Poly ICLC is a stabilized     double stranded RNA which has been extensively studied in humans with a favorable safety     profile.   "
241525|NCT01012713|"     This is a 12-week, open-label, pilot trial evaluating the efficacy and safety of the     combination of Clobex® spray with excimer laser therapy as the initial treatment of     generalized plaque psoriasis, followed by maintenance therapy with topical Vectical. The     study will be conducted in three distinct periods, namely Period A, Period B, and Period C,     each of 4 weeks duration. During Period A (weeks 1 through 4), patients will use Clobex®     spray twice daily along with excimer laser treatments twice weekly with the Photomedex XTRAC®     Velocity machine. The goal of Period A is to achieve Psoriasis Area Severity Index (PASI) 75     in 100% of patients within four weeks. During Period B (weeks 5 through 8), patients would be     treated with topical Vectical® twice daily. Thus, there is a steroid-free interval during     which patients will not be using Clobex® spray. The goal of Period B is to maintain the     patient's response using only non-steroid options. During Period C of the study, patients     will use Clobex® spray BID and Vectical® BID. Period C (weeks 9 through 12) will be a     booster period in which the goal is to see if 100% of patients can achieve Psoriasis Area     Severity Index (PASI) 90-100. Regarding excimer laser therapy: all patients will be receiving     excimer laser therapy twice weekly for the first 6 weeks of the study (up to the halfway     point) which is 12 excimer laser treatments. At that point, only those patients achieving     <Psoriasis Area Severity Index (PASI)75 response will continue to receive twice weekly     excimer laser treatments for the remaining 6 weeks of the study.   "
241526|NCT01012726|"     The investigators will study whether local instillation of Doxycycline and Acetylcystein     results in fistula closure in CD patients.   "
241527|NCT01012739|"     This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different     formulations of indacaterol, one administered via the Concept1 device and one administered     via the Simoon device. The study aimed to determine whether the novel formulation (Simoon)     had a similar profile to that of the established formulation (Concept1).   "
241528|NCT01012752|"     This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific     immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.   "
241529|NCT01012765|"     This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on     inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as     comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In     particular, spirometric timepoints are included to elucidate the peak-IC in a period of     approximately 4 hour post inhalation   "
241530|NCT01012778|"     A multimodal intervention was rolled out at a large public school in Najibabad, Uttar Pradesh     (UP). The program identified elementary school children with ADHD and Dyslexia using standard     screening of all children who had performance impairment in at least one domain of the     Vanderbilt questionnaire. The program consisted of play therapy, physical exercise, yoga and     meditation. The program was established by High school volunteers from The US and UK over 6     weeks. Once implemented during the morning of school, high school volunteers from the school     were trained to continue the program. Vanderbilt questionnaires were completed at intervals     to allow follow up.   "
241531|NCT01012791|"     The main purpose of this study is to compare the effects on attention and memory functioning     to participating in an aerobic and dance exercise called Zumba to educational program on     exercise that encourages regular stretching and walking.   "
241532|NCT01012804|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research study is looking at biomarkers in tissue samples from patients with     metastatic colon cancer.   "
241533|NCT01012817|"     This phase I/II trial studies the side effects and best dose of veliparib and topotecan     hydrochloride and to see how well they work in treating patients with solid tumors, ovarian     cancer that has come back or does not respond to treatment, or primary peritoneal cancer.     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways     to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Giving veliparib with chemotherapy may kill     more tumor cells.   "
241534|NCT01012830|"     Use Huperzine-A, a herbal supplement normally used for treatment of Alzheimer's disease, to     potentially improve cognitive dysfunction (memory problems) and functional capacity (ability     to perform common daily tasks such as cooking, bathing, telephone, shopping) in people with     schizophrenia.   "
241535|NCT01012843|"     Purpose: This randomized study assesses the effects of antibiotics on the formation of     fistulae after drainage of anorectal abscesses.      Methods: Patients who underwent abscess drainage in 3 major colorectal units between     September 2005 and January 2008 were included. Previous anorectal surgery history,     immunecompromised states, pregnancy, inflammatory bowel disease, antibiotic usage prior to     surgery and the presence of an anal fistulae at the time of surgery were the exclusion     criteria. Patients were randomized and given either placebo or amoxicillin-clavulanic acid     combination treatment for 10 days. Patients were followed one year for perianal fistulae     formation.   "
241536|NCT01012856|"     The purpose of this study is to investigate, if exposure-based cognitive therapy (EBCT) is at     least as effective as the established cognitive-behavioral therapy and more effective in its     long-term efficacy. Moreover the mechanisms of change of the EBCT are investigated.   "
241546|NCT01012986|"     Theme: The reading of fixed texts in school are widely known, however it is not known how     they read texts furniture and what skills are required for this type of reading.      Objective: To evaluate the skills of reading film subtitles in students of 2nd and 4th grade     of elementary school of a Public School.      Method: Review the level and skills of reading movies subtitles (RMS), through the recounting     of a section of film watched, alone, mute and legend, for 60 students (30 2nd grade and 30 of     the 4th grade) matched for age and gender.   "
241547|NCT01012999|"     The purpose of this study is to determine the appropriate dose and effectiveness of     intra-nasal administration of a potent narcotic, sufentanil, for the treatment of moderate to     severe pain due to broken bone(s) in the arm or leg.   "
241548|NCT01013012|"     The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for     preventing postoperative nausea and vomiting in highly susceptible patients following spine     surgery.   "
241549|NCT01013025|"     The main study objective was to collect implant retrieval information in 10 patients using     Vantas®, the 50 mg histrelin implant. Patients who had been identified as having a difficult     to locate or non-palpable implant were to have been enrolled. Sites were to adhere to the     instructions in the Package Insert, which included specialized investigations such as     ultrasound, CT, and MRI, to be used for the location and removal of implants.   "
241550|NCT01013038|"     In this trial, the investigators will evaluate the effect of thrombus aspiration followed by     stent implantation in improving myocardial blush grade in patients with acute     non-ST-elevation myocardial infarction compared to conventional percutaneous coronary     intervention (PCI).   "
241551|NCT01013051|"     Background: Gastric bypass is the most commonly performed type of bariatric (obesity)     surgery, has dramatically increased in popularity and is now considered to be preferred     treatments in severely obese patients that fail non-surgical therapy - particularly in     patients with type 2 diabetes. Drug malabsorption is a potential concern post-gastric bypass     because intestinal length is reduced.      Purpose: The purpose of this controlled, pharmacokinetic study is to determine whether the     absorption of a single dose of metformin, the first line drug treatment in patients with type     2 diabetes, is significantly reduced after gastric bypass.      Methods: A single dose of standard release metformin 1000 mg will be administered to patients     who have undergone gastric bypass and to patients who have not received surgery but are on     the wait list (wait-listed controls). Blood sampling and urine sampling will occur in     standardized fashion over the ensuing 24 hours to measure and compare the absorption of     metformin between study arms. 34 patients total will be recruited.      Significance: Following completion of this study, we will better understand how gastric     bypass affects metformin absorption. Ultimately, this information will help to ensure that     this patient population is receiving optimal doses of this important drug treatment.   "
241552|NCT01013064|"     Study design:        -  Randomized, double-blind, placebo-controlled, sequential dose escalation        -  Six ascending dose cohorts are planned      Primary Objective:        -  To evaluate the safety profile of single escalating intravenous dose levels of HM10760A   "
241553|NCT01013077|"     The purpose of this study is to investigate how the addition of a new emulsion artificial     tear to the tear layer of dry eye and normal patients affects aberrometry, contrast     sensitivity, and reading ability over time. Previous studies have indicated that daily use of     artificial tears over a two week period decreases the short term affect of drop application     on aberrometry and contrast sensitivity measurements. The present study will examine the     effects of 4 weeks of artificial tear use to determine when the responses stabilize.   "
241554|NCT01013090|"     Hypotension resulted from neuraxial block is a common problem, of which is a special issue in     patients undergoing Cesarean section. A large number of studies and clinical guidelines     suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing     hypotension. However, it is still a controversy because the fact of a relatively increased     blood volume in parturients. In addition, although it is effective of fluid management, it's     precise relationship between fluid (crystalloid or colloid) volume and the proportion of     hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The     investigators designed this trial to clarify the accurate relationship between fluid volume     in an escalated manner and the occurrence of hypotension analyzed with a non-linear     regression, and wanted to present the 50% effective volume (EV50) of fluid including     crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.   "
241584|NCT01019928|"     The purpose of the study is to compare sensitivity of visceral pain in the esophagus using     different pain stimuli.   "
241555|NCT01013103|"     The present study constitutes a study examining the effect of atorvastatin on vascular     function in high cardiovascular risk patients. For this purpose the investigators will record     atorvastatin effects on statin-naïve patients (patients that start statins treatment for     first time). More specifically the investigators will study atorvastatin effects on:        1. Endothelial function        2. Arterial elastic properties        3. Systemic Inflammatory/thrombotic mechanisms        4. Vascular and myocardial redox state   "
241556|NCT01013116|"     The objective of this study is to evaluate the efficacy and safety of specific subcutaneous     immunotherapy with modified allergen extracts.   "
241557|NCT01013129|"     RATIONALE: Gathering information about genetic and environmental factors may help doctors     learn more about a person's risk for developing prostate cancer.      PURPOSE: This clinical trial is studying genes, environment, and prostate cancer risk in     patients with or without prostate cancer and their first-degree relatives.   "
241558|NCT01013142|"     The objective of this clinical study is to determine the safety of intravenous MN-221     compared to placebo when administered in subjects diagnosed with stable moderate to severe     COPD.   "
241559|NCT01013155|"     The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg     tablet under fed conditions   "
241560|NCT01013168|"     The purpose of this study is to collect further data for safety and feasibility for the use     of the medical device OncoSorb® in clinical routine for the treatment of patients with solid     metastatic cancer entities who have failed standard therapies. OncoSorb® device is intended     to specifically adsorb three soluble receptors (sTNF-R1, sTNF-R2 and sIL-2R α), which are     known to inhibit the natural immune response of cancer patients mediated via tumor necrosis     factor α (TNF- α).   "
241561|NCT01013181|"     The purpose of this study is to review the charts of the first 100 patients included in the     french compassionate program including patients with Immune Thrombopenia receiving     romiplostim.   "
241563|NCT01013207|"     Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the     upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway     Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway     pressure to the upper airway via a tube and mask. Humidification is used during CPAP therapy     to improve the comfort of the delivered air and to alleviate nasal dryness/congestion.      The latest design of a CPAP device, known as Nexus (S9), encompasses new features including     an improved humidification system (heated tube and climate control), reduced noise, improved     comfort of breathing, and a new user interface.      This study will assess whether compliance on CPAP therapy is improved on the Nexus (S9) CPAP,     and will assess the usability of the Nexus (S9) CPAP   "
241564|NCT01013220|"     Randomized trials demonstrate that depression management products can improve clinical and     organizational outcomes sufficiently for selected employers to realize a return on     investment. Rather than usual care marketing which uses voltage-enhanced promises to sell     voltage-diminished products, the investigators designed an evidence-based (EB) intervention     to encourage employers to purchase a depression management product that offers the type,     intensity and duration of care shown to provide clinical and organizational value. In an RCT     designed to examine employer benefit purchasing behavior of depression products in 360     employer members of over 20 regional business coalitions, the research team proposes: (a) to     compare the impact of evidence-based (EB) to usual care (UC) presentations on employer     benefit purchasing behavior, and (b) to identify mediators and organizational moderators of     intervention impact on employer benefit purchasing behavior.      This study addresses what policy analysts argue is one of the most pivotal problems in the     translation of evidence-based care to 'real world' settings: whether purchasers can be     influenced to buy health care products on the basis of value rather than cost. In the likely     event that EB > UC, the study will provide encouragement to use an evidence-based approach to     market new health care products to private payers on the basis of the product's clinical and     organizational value. UC may achieve comparable outcomes to EB if the limiting factors in     benefit purchasing are organizational, purchasing group and vendor constraints that no     intervention can meaningfully modify. Support for this scenario would encourage the targeted     marketing of new products to coalition members with empirically identified organizational,     purchasing group and vendor characteristics, using usual care strategies.   "
241565|NCT01013233|"     The purpose of this study is to improve cognitive dysfunction following chemotherapy, the     investigators investigated to see whether a cognitive training for memory and concentration     skills can improve cognitive performance in patients following cancer treatment.   "
241566|NCT01013246|"     The aim of this study is to examine the effects of playing video games on various components     of energy balance and substrate metabolism as well as on glucose homeostasis and relevant     hormonal systems that might be involved in the underlying mechanisms.   "
241567|NCT01013259|"     Due to the worldwide increasing prevalence of the allergic rhinoconjunctivitis, new     therapeutical strategies are needed. The symptomatic treatment with topical and systemic     antihistamines and corticosteroids are often insufficient. E.coli Nissle 1917 has     immunomodulatory capacities and reveals less side effects. E.coli Nissle 1917 has no sedative     properties and exhibits no hepatotoxic qualities. Thus, E.coli Nissle 1917 represents a new     relevant therapeutical agent.   "
241568|NCT01013272|"     Patients with chronic hepatitis B and treated with entecavir for over 6 months (with no     previous other antiviral treatment) will be invited to participate in this study. They will     be eligible if their liver tests are normal and their viral load is undetectable. Patients     will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate     suppression of the hepatitis B virus after successful treatment with entecavir. Patients will     be monitored closely after switching treatment at 1 months and then every 3 monthly. If there     is any evidence of increase in viral load then patients will be given the option of changing     back to entecavir.   "
241585|NCT01019941|"     The purpose of this study is to evaluate safety and the pharmacokinetic characteristics of     docetaxel between two docetaxel products in patients with advanced solid cancer.   "
241623|NCT01021670|"     The purpose of the study is to collect information regarding the safety of dapoxetine     hydrochloride when used in clinical practice to treat men with premature ejaculation.     Dapoxetine hydrochloride is a selective inhibitor of serotonin reuptake that is indicated for     the treatment of patients with premature ejaculation.   "
241569|NCT01013285|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such     as temozolomide, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to     kill tumor cells. Giving bevacizumab together with temozolomide and radiation therapy may     kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab     together with temozolomide and external beam radiation therapy works when given as first-line     therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma.   "
241570|NCT01013298|"     The purpose of this study is to determine the feasibility, safety and effectiveness of an     endotracheal tube embedded with a mini video-camera as a guiding tool for percutaneous     tracheostomy.   "
241571|NCT01013311|"     The purpose of this study is to identify patients with cardiac sarcoidosis who may be at risk     for sudden death.   "
241572|NCT01013324|"     There has not been any systemic therapy approved in the United States or in Europe for     treating advanced or recurrent endometrial cancer (EC). This study will evaluate the safety     and preliminary efficacy of XL147 in advanced or recurrent EC.      Constitutively active phosphatidylinositol-3 kinase (PI3K)/phosphatase and tensin homolog on     chromosome 10 (PTEN) pathway signaling is common in EC and involved in the development and/or     progression of the disease. PTEN deficiency and/or activating mutations/amplification in the     PIK3CA gene that encodes the p110α catalytic subunit of PI3K have been frequently detected in     EC patients. XL147 is a potent and highly selective inhibitor of the Class I PI3K family of     lipid kinases. In addition, in vivo preclinical data have demonstrated that XL147 targets     both proximal and distal signaling in the PI3K/PTEN pathway. Therefore, XL147 may have     utility in the treatment of subjects with advanced or recurrent EC.   "
241573|NCT01013337|"     RATIONALE: Acupuncture may help relieve moderate or severe joint pain caused by aromatase     inhibitors.      PURPOSE: This randomized phase II trial is studying acupuncture in treating women with stage     I, stage II, or stage III breast cancer with aromatase inhibitor-related joint pain.   "
241574|NCT01013350|"     Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients who Have     Participated in Cladribine Clinical Trials   "
241575|NCT01013363|"     Most first trimester abortions are performed under local anesthesia using either manual or     electric vacuum suction aspiration. The majority of women undergoing these procedures     experience some amount of pain and anxiety. The investigators seek to understand if the     provision of music during first trimester abortion will reduce pain and anxiety associated     with this procedure. This study will involve the use of music during first trimester abortion     as an additional method of pain and anxiety control. The investigators will recruit women     seeking a first trimester suction aspiration procedure primarily for elective pregnancy     termination or for other related indications such as an abnormal pregnancy, inevitable     abortion, or retained products of conception. Participation will be voluntary and include     informed consent. Recruited women will be divided into two groups: control group (no music)     and intervention (music) group. All subjects will receive routine care and standard pain     control measures, including local anesthesia, during their procedure. Those assigned to the     intervention group will receive a portable digital music player (iPOD™ Nano) with headphones     to listen to during their procedure. All subjects will complete preoperative and     postoperative pain and anxiety questionnaires in addition to a patient satisfaction survey at     the end of their visit. The provider will also assess and record the subject's pain     experienced during the procedure. The investigators will also measure preoperative and     postoperative vital signs on all participants. Subjects will be compensated for their time     and study participation will not affect any care received at the clinic. Upon completion of     their visit, there will be no additional followup for this study.   "
241576|NCT01019824|"     The aim of the study is to determine if an experimental drug, ralfinamide, relieves your     neuropathic low back pain, and if it demonstrates superiority to placebo, a dummy or sugar     pill that contains no active medication. Ralfinamide, given as either 160 mg/day or 320     mg/day, taken in a divided dose twice-a-day, will be compared with placebo. If you are     randomly (by chance) selected to receive placebo, you will receive this medication throughout     the treatment period of the study. Data from this study will provide essential information     for choosing the doses of ralfinamide to be used in the treatment of this type of pain and     potentially other types of pain.   "
241577|NCT01019837|"     The spread of Influenza H1N1 has prompted the development of vaccines against this virus. IBD     patients are at increased risk of developing complications of Influenza H1N1. The efficacy     and safety of H1N1 vaccination have not been evaluated in this population of patients. We     would like to estimate the efficacy and safety of vaccination against influenza H1N1 in     patients with IBD who treated with immunomodulatory drugs.   "
241578|NCT01019850|"     RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Radioactive drugs, such as iobenguane I 131, may carry radiation     directly to tumor cells and not harm normal cells. Giving vorinostat together with iobenguane     I 131 may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of giving vorinostat     together with iobenguane I 131 in treating patients with resistant or relapsed neuroblastoma.   "
241579|NCT01019863|"     Evaluation of the efficacy, tolerance, quality of life and cost effectiveness of the     association of Oxaliplatin, Gemcitabine, Rituximab and Dexamethasone for treatment of     patients with refractory or relapsing non-Hodgkin lymphoma.   "
241580|NCT01019876|"     Reduced intensity conditioning followed by allogeneic stem cell transplantation will result     in mixed/complete donor chimerism and potentially alter the natural history and outcome of     patients with non-malignant diseases.   "
241581|NCT01019889|"     The purpose of this study is to determine whether Socheongryong-tang (SCRT) and     Yeongyopaedok-san (YPS) are effective in the treatment of upper respiratory tract infection.   "
241621|NCT01021644|"     The primary purpose of this pilot study is to determine whether African Americans with mild     Alzheimer's disease (AD) can be enrolled and retained in a 6-month aerobic exercise-training     study.   "
241586|NCT01019954|"     This is a study to evaluate the safety and find the highest tolerable dose of Levulan® and     Photodynamic Therapy (PDT) for premalignant tumors of the head and neck. Subjects will     receive Levulan® by mouth and will undergo PDT. Levulan® goes throughout the body, but gets     retained in cancer cells more than non-cancer cells. After 4-6 hours, the targeted area is     treated with laser light which activates the Levulan® to kill the cells that contain it.   "
241598|NCT01020110|"     Evaluation of fibrin and platelet deposition on a human umbilical endothelial cell surface in     perfusion chamber experiments using human whole blood.      Open-label, non interventional study Perfusion chamber experiment will be performed in 30     healthy patients. The Impact of different pH-solutions on thrombus lysis will be evaluated in     an in-vitro second step      Outcome:      D-Dimer content of the thrombus reflecting the size of the thrombus.   "
241599|NCT01020123|"     The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on     Treatment to Metformin in TD2M Patients   "
241600|NCT01020136|"     The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug     concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing     under fed conditions.   "
241601|NCT01020149|"     To prospectively evaluate the nerve regeneration after traumatic nerve transsection using     diffusion tensor magnetic resonance imaging (DTI MR imaging).   "
241922|NCT01010646|"     Three-parallel-arm, open-label, international (France and Romania) study, comparing three     treatments      The purpose of this study is to confirm if IFN alfa-2b XL has a better antiviral activity and     tolerability as compared with current marketed reference, while combined with ribavirin, in a     3-month therapy setting.   "
241587|NCT01019967|"     Background:        -  Obsessive-compulsive disorder (OCD) is a common childhood disorder that often does not          respond to standard treatments. Researchers are exploring the role that a brain chemical          called glutamate plays in symptoms of OCD, and are testing a drug called riluzole that          reduces glutamate to see if changing the levels of glutamate in the brain will help          treat the disorder.        -  Researchers are interested in using magnetic resonance spectroscopy (MRS), a type of          magnetic imaging, to take pictures of various chemicals in the brain. MRS images will be          used to detect changes in brain levels of glutamate in children taking riluzole.      Objectives:      - To use magnetic resonance spectroscopy to study the levels of glutamate in the brains of     children and adolescents who have been taking riluzole.      Eligibility:      - Children and adolescents ages 7 to 17 who are enrolled in the current NIMH riluzole trial     protocol (05-M-0225), who are able to lie still in the scanner for about an hour each time,     and who are willing to have up to three MRS scans.      Design:        -  Researchers will study some children/adolescents before they begin to take the study          medication riluzole or placebo these children will have an MRS scan before starting the          study medication. The scan will take about an hour.        -  About 2 weeks after reaching the full dose on the study medication, participants will          have a second hour-long MRS scan. Participants will have a third MRS scan after being on          the study medication for 12 weeks.        -  Some children who have already completed 12 weeks on riluzole or placebo, and are now          taking riluzole, will have only one MRS scan.   "
241588|NCT01019980|"     The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg)     is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of     fever during 2 hours, in the treatment of febrile children with acute upper respiratory     infections.      This is a comparative double blind, double dummy, randomized study on the effectiveness of     Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory     tract infections. The patient will be randomized to either group: Group A (Diclofenac     potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional     trained will measure the temperature during 2 hours. During the study period, parents or     legal representatives will be invited to fill a survey about the habits and knowledge     regarding fever management at home.   "
241589|NCT01019993|"     The investigators hypothesized that the application of volume-controlled HFPPV to the     non-dependent lung during one-lung ventilation (OLV) for thoracotomy in patients with good     pulmonary functions and mild-to-moderate pulmonary dysfunction may provide preservation of     the right ventricular (RV) function, adequate oxygenation and optimum surgical conditions.      The investigators evaluated the effects of IL-HFPPV on RV ejection fraction (REF), RV     end-diastolic volume (RVEDVI), RV stroke work (RVSWI), pulmonary vascular resistance (PVRI),     and stroke volume (SVI) indices, oxygen delivery (DO2) and uptake (VO2), shunt fraction (Qs:     Qt), and surgical field conditions during OLV for thoracotomy in patients with good and     mild-to-moderate impaired pulmonary functions.   "
241590|NCT01020006|"     The purpose of this study is to evaluate the safety and tolerability of selected dose     1.2mg/kg BID dosage administered subcutaneously (SC) administered PCI-27483 to metastatic or     locally advanced pancreatic cancer patients receiving concurrent therapy with intravenously     administered gemcitabine for 12 weeks.   "
241591|NCT01020019|"     The purpose of this study is to see if Lofexidine in combination with Marinol is superior to     placebo in achieving abstinence, reducing cannabis use and reducing withdrawal in     cannabis-dependent patients seeking treatment for their marijuana use.   "
241592|NCT01020032|"     The aim of study is to assess the effects of this new music therapy technique on pain     treatment, anxiety and depression and on medicinal consumption.   "
241593|NCT01020045|"     Advances in HAART have been a huge success story in the management of HIV infection. However,     serious metabolic complications including osteoporosis and bone fractures are increasingly     been seen with HAART, and the responsible mechanisms remain poorly elucidated.      The skeleton continually regenerates through homeostatic bone remodeling. Osteoclasts the     cells responsible for bone resorption form under the influence of the key osteoclastogenic     cytokine Receptor- Activator of NF-KB (RANKL). The osteoclastogenic and pro-resorptive     activities of RANKL are moderated by its physiological decoy receptor osteoprotegerin (OPG).     Increase in the ratio of RANKL to OPG accelerates the rate of osteoclastic bone resorption     leading to osteoporosis.      The investigators' preliminary studies have now demonstrated that in an animal model of     HIV/AIDS, the HIV-1 Transgenic rat, the development of osteoporosis is recapitulated as     observed in human patients. Furthermore, the investigators found that B cell expression of     OPG is significantly downregulated, concurrent with a significant upregulation in production     of RANKL.   "
241594|NCT01020058|"     The purpose of this study is to compare the frequency of long-term post operative pain after     an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an     totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The     investigators will also be assessing the cost for the procedures and hospital care as well as     the cost for sick-leave depending on procedure performed. The study hypothesis is that the     laparoscopic approach will be associated with less long term post operative pain.   "
241595|NCT01020071|"     Objective: The main objective of this study is to evaluate the efficacy of Pascal Laser     Iridotomy and Pascal Laser Peripheral Iridoplasty in lowering intraocular pressure and     opening up the angles in patients with narrow angles, primary angle closure and primary angle     closure glaucoma.      The specific objectives are to evaluate the pain and inflammation associated with the     procedure and its possible adverse effects on the lens and corneal endothelium.      Study Design: Prospective, interventional case series Study Population: Healthy males and     females with appositional angle closure aged 21 y/o and above Methods: Potential participants     are evaluated by a glaucoma specialist in National University Hospital. If they are     identified as having appositional angle closure they are invited to participate in the study     and assigned to either iridotomy or iridoplasty depending on the mechanism of angle closure     present. Pupil block for Pascal Laser Iridotomy and plateau iris and angle crowding for     Pascal Laser Peripheral Iridoplasty. If they agree to participate they will undergo visual     acuity, slit lamp examination, intraocular pressure determination by Goldmann Applanation     Tonometry, gonioscopy, optic nerve head evaluation by indirect ophthalmoscopy and lens     evaluation by LOCS III opacity grading system. Humphrey visual field examination using 24-2     SITA standard algorithm and stereodisc photos will be obtained if not done within the past 12     months. Anterior segment OCT and laser flare meter will also be performed prior to the     procedure. Enrolled patients will be divided into 2 groups. The first group will be assigned     to Pascal Laser Iridotomy. The primary mechanism of angle closure in this group is pupillary     block. The second group will be assigned to Pascal Laser Peripheral Iridoplasty. This group     has non-pupil bock mechanisms which include plateau iris or angle crowding. After the laser     procedure, follow-up examinations will be done 1 hr post laser, 1 week, 1 month, 3 months and     6 months.      Outcome Measures: The primary outcome measures are the intraocular pressure difference pre     and post laser and the opening of angles. Secondary outcome measures are pain and     inflammation associated with laser procedure, lens and corneal endothelial changes.   "
241602|NCT01021384|"     The objective of this 2 year research project is to determine whether an evidenced-based     empowerment strategy, Problem Solving Education (PSE), targeted to mothers of young children     with autism spectrum disorders (ASDs), promotes family well-being by decreasing the burden of     maternal depressive symptoms and maternal parenting stress and improving social functioning.     We propose a randomized control trial involving 140 mothers who have children <4 years with     confirmed ASDs. Based on the paradigm of the IOM report on mental health prevention research     that highlights the importance of targeting interventions to at-risk populations who may not     meet diagnostic criteria, all mothers of young children with ASDs will be eligible to     participate. Consistent with previous studies of cognitive-behavioral interventions, the     mother-child pairs will be followed for 9 months. The intervention will be embedded in two     settings that provide services to young children with ASDs - Early Intervention (EI) programs     and specialty developmental assessment clinics. We aim to support families during a critical     juncture - when they are confronted with a new diagnosis and are asked to navigate a complex     service system on their children's behalf. The hypothesis of this proposal is that     strengthening problem solving skills among mothers of young children with ASDs serve as an     important buffer against the negative impact of life stressors, and thereby prevent and     attenuate depressive symptoms and parenting stress.   "
241603|NCT01021397|"     Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children     under 5 years of age, causing serious respiratory tract disease. The primary purpose of this     study is to test the safety of and immune response to a new HPIV vaccine in healthy infants     and children.   "
241604|NCT01021410|"     The purpose of this study is to better understand the pharmacokinetics of acetaminophen and     further clinical interpretations of laboratory results that confirm the presence of     acetaminophen-cys adducts. This study will determine how long adducts persist in serum after     a therapeutic course of acetaminophen as taken in a previous study (COMIRB 06-1265). Subjects     will be asked to complete three study visits, each three days apart, following termination of     COMIRB 06-1265. Each study visit will include collection of blood samples for batch testing     of aminotransferase, serum acetaminophen and protein adducts. No interventions are planned.   "
241605|NCT01021423|"     A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of     first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not     candidates for transplantation and have achieved partial response (PR) or complete response     (CR).      This study was prematurely terminated by the sponsor in light of new unpublished data that     rendered the current design of the study no longer clinically relevant. A study design with     the control arm of no active treatment was no longer appropriate. The termination of the     trial was not based on any safety concerns in the study.   "
241606|NCT01021436|"     This study is to understand how the inhaled form of amikacin is spread throughout the human     body and how it is eliminated from the body and to make sure that giving an inhaled form of     Amikacin to patients is safe and well tolerated   "
241607|NCT01021449|"     In this proposal, we will (1) detect the associations between BDNF and Trk B gene DNA     methylation, histone modification, psychotic symptoms, obesity, suicide and antipsychotic     drug responses in Taiwanese patients (2) discuss the possible mechanisms of epigenetic     regulation of BDNF and Trk B in schizophrenia patients.   "
241608|NCT01021462|"     A two period pilot study to determine if a graded glucose infusion using a glucose (20%     dextrose [D20]) intravenous infusion can be properly implemented and will be well tolerated     in healthy subjects.   "
241609|NCT01021475|"     The goal of this study is to determine if Visceral Manipulation (VM) is effective in treating     Functional Dyspepsia in addition to drug therapy.      Null hypothesis is that VM does not influence FD symptoms.   "
241610|NCT01021488|"     Deep vein thrombosis (DVT)is devastating disease which influencing the mortality and     morbidity of patients at-risk like those undergoing orthopedic surgery.      Recent publication suggested HMO-co-A reductase inhibitor (statin) may reduce the occurrence     rate of venous thromboembolism in apparently healthy persons.      The pleiotropic property of statin like antioxidant, antithrombotic, anti-inflammatory may     have effect on the positive results.      We are investigating whether rosuvastatin is associated with lower incidence of deep vein     thrombosis (DVT) in patients undergoing total knee replacement arthroplasty(TKRA)who are     at-high risk for developing DVT   "
241622|NCT01021657|"     The purpose of this study is to provide data on the lipid profile of the Tenon's capsule in     Human glaucomatous eyes and to establish possible relationships with the short term outcome     of filtration surgery.   "
241611|NCT01021501|"     This is a prospective, open, non-randomized, non-controlled study. 20 patients with     hypertension on chronic maintenance hemodialysis will be enrolled in the study. All patients     had mild to moderate hypertension and are receiving antihypertensive agents.      This study was designed to investigate effects of Adalat GITS on hemodialytic blood pressures     in patients with chronic hemodialysis by using ABPM and measuring the drug plasma     concentrations. For the purpose of investigating the influence of hemodialysis on the drug     plasma concentration as well as its efficacy, it should be necessary to assign the subjects     with the Adalat monotherapy. Since most patients in the hemodialysis center will be those who     need and already receive combination therapy, it would be practical to start Adalat 60mg/day     monotherapy to remain similar antihypertensive effect when discontinuing the previous     treatment in this study population to be screened and enrolled. And taking into the     consideration of clinical practice, few patients undergoing hemodialysis could be well     controlled by low dose Adalat 30mg/day alone. So this study will evaluate the effect and     safety of Adalat GITS 60mg/day alone and thereafter the influence of hemodialysis on the drug     plasma concentration without any other possible drug interaction. The agents are given orally     once a day at 08:00h and patients are followed for at least 4 weeks. After that,the patients     whose blood pressure are well controlled by Adalat GITS 60mg/day by office blood pressure     would be enrolled for further ABPM assessment and plasma concentration evaluation.   "
241612|NCT01021514|"     Arteriosclerosis is a dynamic inflammatory disorder. Recently, FDG-PET CT is emerging     diagnostic tool of non-invasive technique to detect vulnerable atherosclerotic plaque. And     there are arising evidence that sRAGE(soluble Receptor for Advanced glycation End Product) is     correlated with metabolic risk. So the investigators will investigate association between     sRAGE and FDG-PET uptake in large artery in healthy patient.   "
241613|NCT01021527|"     A four-period study to evaluate if the grade glucose infusion procedure will be able to     detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment     in healthy subjects.   "
241615|NCT01021553|"     To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior     efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an     8 week study period compared to placebo in men with primary premature ejaculation. An     assessment of the safety and tolerability of all doses of GSK557296 will be performed as well     as an assessment for change in the Index of Premature Ejaculation (IPE) from baseline and at     the end of the 8 weeks of treatment. During the active treatment period study participants     will be limited to a maximum of 40 doses of GSK557296, or placebo, spilt as 20 doses for both     4 week intervals.   "
241616|NCT01021566|"     The purpose of this study is to determine whether combined hemoperfusion-hemodialysis     treatment is an alternative drug-free, effective, and safe treatment for opiate     detoxification.   "
241617|NCT01021579|"     Polycystic ovary syndrome (PCOS) is a common endocrinopathy affecting 6.5%-6.7% of women in     reproductive age, and is commonly associated with obesity, menstrual irregularity, insulin     resistance (IR), infertility, and clinical hyperandrogenism and/or hyperandrogenemia (1,2).     PCOS is also associated with increased risk of abnormal lipoproteins and hypertension, as     well as cardiovascular or cerebrovascular morbidity (3). The lipid and lipoprotein profile in     androgenized women with poly cystic ovaries is similar to the made pattern with higher levels     of cholesterol, low-density lipoprotein (LDL), and lower levels of high-density lipoprotein     (HDL), and this abnormal pattern is independent of body weight (4). Insulin resistance is     associated with reproductive abnormalities in women with PCOS. Improving insulin sensitivity     through both lifestyle and pharmacological intervention can ameliorate these abnormalities.     Insulin resistance in women with PCOS is common (up to 50%), both in obese and nonobese women     (5), and disordered insulin action precedes the increase in androgen.      Treatment for PCOS subjects typically includes, implementation of lifestyle changes     especially weight loss and adjuvant pharmaceutical intervention including oral     contraceptives, anti-androgen therapy and insulin-lowering drugs (such as, metformin) (6).     Metformin is a biguanide used extensively in type 2 diabetes. It inhibits hepatic glucose     production and increases peripheral insulin sensitivity, but dose not cause hypoglycemia.     Several studies have shown an increase in insulin sensitivity and pregnancy rate accompanied     by decreased insulin and androgen levels in PCOS patients taking metformin (7).      The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-COA) reductase inhibitors (statins) are the     rate-limiting step in cholesterol biosynthesis, and inhibition of this enzyme decreases     cholesterol synthesis and a compensatory increase in the expression of LDL receptors in the     liver. Statins reduce plasma triglycerides in dose-dependent fashion and also have a modest     HDL-raising effect which is not dose-dependent (8,9). Furthermore, statins pose other     cardio-protective properties, including antioxidant and anti-inflammatory actions (10,11).      Some studies have reported that simvastatin decreases serum androgen levels in women with     PCOS (12,13) by inhibiting proliferation and steroidogenesis of ovarian theca-interstitial     cells (14). According to these previous findings, we hypothesized that combination therapy     with simvastatin and metformin will result in lower androgen levels and cardiovascular risk     factors in women with PCOS.   "
241618|NCT01021592|"     This observational study will observe the degree of the quality of life in patients with     multiple myeloma before and after bortezomib administration by using EORTC-QLQ C30 (European     Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and     EQ-5D (EuroQol-5 Dimensions). Both tools are validated research instruments used to measure     the quality of life in cancer patients and consequently will provide fundamental data     regarding the quality of life in patients with multiple myeloma by analyzing factors that     affect the quality of life.   "
241619|NCT01021618|"     Not infrequently, a physician is faced with uncertainty regarding the ability of a patient to     perform adequate exercise in the noninvasive evaluation of known or suspected coronary artery     disease (CAD) by the use of radionuclide stress myocardial perfusion imaging. In selected     patients, protocols that combine exercise (either low-level or symptom-limited) with     vasodilator stress agents have been found to be safe and effective in both identification of     the presence and severity of CAD as well as risk stratification for adverse cardiac outcome.     However, currently utilized combined stress protocols have drawbacks. Further refinement of     combined stress protocols would potentially lead to more appropriate stress protocol     selection for patients while enhancing laboratory efficiency. The purpose of this     prospective, randomized study will be to evaluate the relative merits of combining     regadenoson with symptom-limited exercise in patients clinically-referred for     vasodilator-exercise stress myocardial perfusion imaging for the assessment of known or     suspected CAD. It is hypothesized that combining regadenoson with symptom-limited exercise is     a safe and feasible stress testing modality which is non-inferior to that which combines     symptom-limited exercise with dipyridamole.   "
241620|NCT01021631|"     Blood transfusion is related to worse outcomes and the triggers for red blood cells     transfusion are not well defined in cardiac surgery. Retrospective studies in cardiac surgery     do not show benefits of red blood cell transfusion in reduction of morbidity and mortality in     cardiac surgery. There are no prospective studies comparing outcomes between restrictive or     liberal strategy in cardiac surgery.This study is a double-blind randomized study comparing     clinical outcomes between two strategies of transfusion in cardiac surgery - liberal or     restrictive.   "
241624|NCT01021683|"     The purpose of this observational study is to investigate whether a sufficient concentration     of itraconazole can influence disappearance of a fever (defeverscence) when intravenous (into     the vein) itraconazole is administered for resolving unknown neutropenic fever of     participants who are given itraconazole oral solution as a prophylaxis under general     treatment conditions.   "
241625|NCT01021696|"     In nursing homes (NHs) 80% of the patients have dementia, between 60%-80% exhibit behavioural     disturbances (BPSD), and more than 60% have pain. Both pain and BPSD is more common in those     with severe dementia. Since older persons with dementia have less communicative skills,     suffer from more pain and exhibit more agitation, pain may be a contributing factor in these     patients. More than 40% of patients with BPSD are treated with neuroleptics despite described     side-effects. There is an urgent need to investigate the impact of individual pain management     on BPSD in patients with dementia.      It was hypothesized that        -  pain increase BPSD in patients with dementia        -  individual pain treatment decrease BPSD in patients with dementia   "
241923|NCT01010659|"     The purpose of study is to investigate the safety and efficacy of lacrimal silicone     intubation for the management of epiphora.   "
241626|NCT01021709|"     Among antidepressant treatments, ECT stands as the most effective in treating acute     depression. However, patient concerns with the cognitive side effects of ECT have encouraged     the development of new and more focal forms of brain stimulation such as transcranial Direct     Current Stimulation (tDCS). Our current study of tDCS as a treatment for depression suggests     that this technique has antidepressant effects and is safe, painless and well tolerated.     However, not all patients may respond to this treatment in the way that it is currently     administered and the concern of possible relapse in some patients who respond to tDCS has     raised interest in finding alternative, possibly more optimal ways of administering tDCS.     This study will investigate whether using alternative electrode montages can improve the     antidepressant effects of tDCS in people suffering from depression.   "
241627|NCT01021722|"     Long-term results after obstetric anal sphincter tears (AST) is poor. The investigators aim     to improve the long-term outcome after AST in terms of symptoms of anal incontinence.      A prospective study at, Malmö University Hospital. Twenty-six women with at least grade 3B     AST were classified and sutured in a systematic way, including separate suturing of the     internal and external sphincter muscles with monofilament absorbable sutures. The principal     outcome was a difference in anal incontinence score, based on six questions, between the     study group and two control groups (women with prior AST [n = 180] and primiparous women     delivered vaginally without AST [n = 100]).   "
241628|NCT01021735|"     That anti-TNF therapy and rituximab therapy are equally effective in treating patients with     rheumatoid arthritis who meet the eligibility criteria for biologic therapy in the British     Society for Rheumatology guidelines, and have not previously been exposed to biologic     therapy.   "
241629|NCT01021748|"     This study will investigate the safety and tolerability of combination therapy with MK-2206     and AZD6244 and determine the maximum tolerated dose (MTD) and recommended Phase 2 dose     (RPTD) for this drug combination in the treatment of participants with locally advanced or     metastatic solid tumors. Preliminary efficacy data will also be collected.   "
241630|NCT01021761|"     Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will     be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects     will be instructed to begin dosing the study medication in the operative eye the day before     surgery and continue dosing on the day of surgery. Beginning one hour before surgery 1 drop     of study medication will be instilled by operating room staff approximately every 15 minutes     for a total of 3 doses. At the designated time a paracentesis will be performed at the start     of the cataract procedure and at least 0.15cc of aqueous humor will be collected. The sample     will be immediately stored on dry ice and shipped to a laboratory for analysis.   "
241631|NCT01021774|"     The purpose of this study is to determine whether the outcome of anal fistula repair with a     collagen plug is comparable to that of repair by a mucosal advancement flap.   "
241632|NCT01021787|"     To determine the penetration of micronized and pigmentary TiO2 in Formulas 283419 2 and     760.001 into the stratum corneum of Compromised (Induced Sunburn) human skin via skin     stripping of human subjects.   "
241633|NCT01021800|"     Interventional study of modulation of immune response in patients with pancreatic tubular     adenocarcinoma after resection and gemcitabine treatment. When included, patients are     pre-treated with moderate doses of cyclophosphamide. Then infusions of allogeneic mononuclear     cells are given.   "
241634|NCT01021813|"     This study will establish the safety and tolerability of suvorexant (MK-4305) when     administered for up to 14 months. Participants will be randomized to receive suvorexant or     placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the     12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the     time of initial randomization, participants assigned to receive suvorexant during the initial     12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either     suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants     randomized to receive placebo in the initial 12-month Treatment Phase will continue to     receive placebo during the 2-month Randomized Discontinuation Phase.      The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out     Phase, and will assess rebound and withdrawal.   "
241635|NCT01021826|"     The purpose of this study is to analyze how common stress hyperglycaemia (abnormally high     blood glucose) is in primary hip and knee replacement surgeries and which factors predispose     to hyperglycaemia.   "
241636|NCT01021839|"     The investigators did a randomized control trial comparing bovine carotid artery grafts with     ePTFE grafts for patients that need hemodialysis access. The goal of the study was to     determine differences in primary and assisted patency rates and frequency of complications     between these two types of grafts. The investigators' hypothesis was that bovine carotid     artery grafts more closely mimic autologous tissue and therefore, would provide better     patency and fewer complications.   "
241637|NCT01021852|"     This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and     effectiveness of different doses of MK-6096 in the treatment of participants with primary     insomnia. The primary efficacy hypothesis was that at least one dose of MK-6096 is superior     to placebo in improving sleep efficiency (SE) as measured by PSG on Night 1 and at the end of     4 weeks of treatment (Week 4).   "
241653|NCT01022060|"     The purpose of this study is to determine whether Renalof administration promotes partial or     total dissolution of urinary calculi and improves physicochemical parameters and metabolic     activity in patients with recurrent calcic urolithiasis. The duration of this double-blind     placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients     to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters     will be assessed every 4 weeks.   "
241654|NCT01022073|"     Follow up of patients enrolled in CSP 468, a study of deep brain stimulation treatment for     Parkinson's disease   "
241804|NCT01008267|"     SWL is widely used in the treatment of patients with renal and ureteral calculi. Several     factors determine the success of extracorporeal shockwave lithotripsy (SWL) for kidney     stones: stone size, stone location within the collecting system, stone type, and the SWL     machine used. Moreover, in some cases it is very difficult to focus on the stone because of     its movement as a results of breathing. In order to prevent stone movement we want to use a     bronchial blocker, processing a selective ventilation of the opposite side of stone location.   "
241638|NCT01021865|"     The overall goal of this proposal is to determine the effects of acute hyperglycemia and its     modulation by Glucagon-like Peptide-1 (GLP-1) on myocardial perfusion in type 2 diabetes     (DM). This study plan utilizes myocardial contrast echocardiography (MCE) to explore a) the     effects of acute hyperglycemia on myocardial perfusion and coronary flow reserve in     individuals with and without DM; and b) the effects of GLP-1 on myocardial perfusion and     coronary flow reserve during euglycemia and hyperglycemia in DM. The investigators will     recruit individuals with and without DM matched for age, gender and degree of obesity. The     investigators will measure myocardial perfusion at rest and during vasodilator stress (to     ascertain coronary flow reserve) while subjects are under controlled pancreatic clamp     conditions during euglycemia (glucose ~100 mg/dl) and hyperglycemia (glucose ~250 mg/dl) in     the presence and absence of concomitant GLP-1 infusion. The investigators believe that the     translational significance of their studies is immense, impacting upon both acute and chronic     cardiovascular disease manifestations. The effect of glycemic control on cardiovascular     outcomes, morbidity and mortality remains an area of active investigation, fueled by the     recent conflicting results of several large clinical trials (ACCORD, United Kingdom     Prospective Diabetes Study (UKPDS), ADVANCE, VADT). If the investigators find that     hyperglycemia is associated with altered myocardial perfusion, the mechanistic implications     in the prevention and management of acute and chronic cardiovascular diseases in DM will be     groundbreaking. Furthermore, if GLP-1 augments myocardial perfusion (as it does in the     peripheral vasculature), the therapeutic benefits for prevention of cardiovascular events in     this predisposed population are clear.   "
241639|NCT01021878|"     1. LOCATION OF STUDY: Multicentric study in Brazil.        2. PURPOSE OF THE STUDY: To measure changes in HOMA index when non-diabetic patients in APD          were exposed to 7,5% Icodextrin for the long-dwell; and to compare such changes with          those produced by 2,5% glucose for the long-dwell.        3. PRIMARY OUTCOME: The primary efficacy outcome was to measure HOMA index to set the          differences with regard to baseline values of this variable for the two groups as well          as in each group, which showed control of the glucose metabolism.      STAGE OF THE STUDY : Phase IV postmarket study      DESIGN: Randomized, open-label, multicenter study. Patients were randomized to receive either     to Extraneal (7,5% Icodextrin) or 2.5% Dianeal during the long-dwell.      SAMPLE SIZE: Randomization Upon completion of the study TOTAL: 120 60 ExtranealTM 60 30     Dianeal® 60 30      Duration: 1 year.   "
241640|NCT01021891|"     Trial will include 40 subjects and consists of 3 visits: Screening, Treatment and Follow up.     A euglycemic clamp procedure and Technosphere®/Insulin (T/I) administration will occur at     Visit 2 for both COPD and non COPD subjects.   "
241641|NCT01021904|"     In a hospital-based multi-center study in China, HPV 16 was found to be the predominant type     (72.9%) in cervical cancer, followed by HPV 18(8.0%) which indicated that if the HPV     prophylactic vaccine are wisely applied in China, about 80% of cervical cancer can be     prevented.The reported prevalence of HPV in the female population in China was about 13.2%,     with women in the study between ages 15-55. HPV prevalence peaks in young adults (ages     20-24:15.5%) and pre-menopausal women (ages 45-49:15%) and this suggests an underestimation     of cervical cancer burden in China.      So far, there is no nation wide organized screening program in China, nor is the vaccine     available for girls innocent to HPV infection. This study aims to vaccinate the daughters     (aged between 13-15 yrs) living in the selected study areas thus to evaluate how cervical     cancer and other HPV related diseases can be curbed through primary and secondary     prevention(in company to screening the mothers aged 35-54 yrs) and to develop a China     specific model for cervical cancer prevention through HPV vaccination and HPV DNA test     (careHPV).   "
241642|NCT01021917|"     The overall purpose of this research is to evaluate the long-term outcomes associated with     participation in Medifast Direct and Take Shape For Life weight-loss programs in comparison     with non-Medifast weight-loss programs. Another important goal of this research is to     determine whether the differences between Medifast Direct and Take Shape For Life programs     affect weight-loss and maintenance of weight-loss in customers.   "
241643|NCT01021930|"     Diabetic patients are prone to a diffuse and rapidly progressive form of atherosclerosis.     Both clinical and angiographic outcomes following percutaneous coronary intervention (PCI)     are poor in patients with DM compared with those without DM. Autopsy study has shown delayed     neointimal healing with inadequate endothelialization and persistent stent surface ﬁbrin     deposition after DES implantation in DM patients. This might partially contribute to the high     risk of late stent thrombosis.      YINYI Polymer-Free paclitaxel stent is a domestic new type stent with bare metal base with     micro porous surface. However, limited data is available in vivo about the surface coverage     after stent implantation in DM patients because of lack of sensitive imaging modalities.     Optical coherence tomography (OCT) is an optical analogue of intravascular     ultrasound（IVUS）that allows high-resolution tomographic intravascular imaging. Furthermore,     several studies have demonstrated the feasibility of OCT to quantitatively evaluate the     surface coverage and stent conditions in the follow up after PCI .      Therefore, the aim of this study was to analyze the surface coverage and late malapposition     after two types of DES implantation in DM patients compared with non-DM patients by using OCT     and IVUS.   "
241644|NCT01021943|"     The main objective of this study is to assess the effect of spironolactone on interstitial     fibrosis in kidney transplant recipients receiving calcineurin inhibitors   "
241645|NCT01021956|"     The objectives of this study is to evaluate the safety(first objective) and efficacy(second     objective)of an experimental drug product,Stakel®, in the treatment of neovascular AMD. The     drug product is activated in patients by exposure to light at a specific wavelength     (Vascular Targeted Photodynamic therapy, VTP). The exploratory objective is to assess     whether it is possible to delay or reduce the requirement for anti VEGF intravitreal therapy     in the first 12 weeks after VTP.      All subjects will have a 52 weeks safety follow up telephone call.   "
241684|NCT01022463|"     The purpose of this study is to study the effect of Ivabradine vs Atenolol on heart rate and     effort tolerance in patients with mild to moderate mitral stenosis and normal sinus rhythm.   "
241685|NCT01022476|"     This phase I/II, multi-center study is designed to determine the pharmacokinetic profile of     Raltegravir in patients with end stage liver disease and to assess drug-drug interaction when     Raltegravir is combined with immunosuppressive therapy in liver transplant recipients.   "
241686|NCT01022489|"     Background:      Repetitive transcranial magnetic stimulation (rTMS) is a recent therapeutic which has     demonstrated its efficacy in the treatment of auditory hallucinations in patients with     schizophrenic disorders. Up to now, the target of stimulation has been over the left     temporoparietal region (based on the international 10-20 EEG system) and rTMS has been     delivered at low frequency (1 Hz).      High frequency (20 Hz) might allow shortening the duration of treatment and so could be more     convenient for the patient (2 days at high frequency instead of 15 days at low frequency).      Besides high frequency, an accurate target taking into account the inter-subjects anatomical     variability might increase the efficacy. Based on a great overlap of language and auditory     hallucinations networks, the investigators hypothesized that targeting the stimulation on the     highest cluster of activation induced by a language task could be an easier and relevant     method to determine the target. The investigators suggest that the best area is located at     the posterior part of the left superior temporal sulcus (STS). Indeed, this area is     considered as an  epicenter  of language, i.e., involved both in understanding and     production of language and in the auditory hallucination network. Therefore, the     investigators conducted an open pilot study in order to test the interest of rTMS at high     frequency (20 Hz) associated with anatomical and functional magnetic resonance imaging (MRI)     and neuronavigation in 11 schizophrenic patients with hallucinations. The investigators     showed a significant reduction of auditory hallucinations; Seven out of 11 patients (63.8%)     were considered as responders at day 12 with a decrease of more than 30% of the score of     Hoffman's scale (Auditory Hallucinations Rating Scale) ; 2 patients presented a drastic     improvement with no hallucinations after 12 days of rTMS. The investigators also showed the     target based on anatomical and functional MRI was located at the intersection of the left STS     and the coronal slice across the vertical line of sylvius sulcus.      The aim of this multicentric double-blind study (randomized and placebo sham) is to     demonstrate the efficacy of rTMS at high frequency with neuronavigation in the treatment of     auditory hallucinations in patients with schizophrenia and schizo-affective disorders     (DSMIV-R).      Methods:      72 subjects will be included after written consent. After randomization, the subject will     receive in a double blind either active treatment or placebo (sham coil) treatment.      rTMS : 4 sessions of 13 minutes, with 2 sessions a day, at 20Hz frequency and at an intensity     of 80% of rest motor threshold will be delivered. These parameters allow the investigators to     be under the risk of epilepsia, the only one severe side effect. Another mild side effect is     headache easily treated by antalgic drugs. The target will be established with anatomical MRI     eventually associated with functional MRI before treatment.      The efficacy of treatment will be evaluated over 4 weeks (D0, D1, D2, D7, D14, D21 and D30).     The primary assessment is the percentage of patients who present a decrease of more than 30%     of the frequency item of Auditory Hallucinations Rating Scale (AHRS) between D1 and D30 at 2     evaluations spaced of 1 week (Responder patients). The secondary assessments are : 1-     Relative decrease of frequency item of AHRS between D1 and D14 ; 2- Evolution of total score     of AHRS at D1, D2, D7, D14, D21 and D30 ; 3- Variation of scores of CGI, SUMD, IS, positive,     negative, general and total PANSS scores between D0 and D14 and D30 ; 4- Scores at secondary     side effects (adapted UKU) at D2 and D7; 5- Distances between the present target and the     classical target based on 10-20 EEG system (T3P3) and/or the target established with     functional MRI (cluster of activations induced by a listening comprehension task).   "
241646|NCT01021969|"     The increasing intake of fructose has been associated with an increase in obesity among US     children and adolescents, but its dose dependent effects on insulin sensitivity and lipid     metabolism has not been studied in detail. Methods: 36 healthy male adult human subjects will     be included in this study. They will be randomly allocated into a low, moderate or high     fructose, a moderate or high glucose and a sucrose diet for 3 weeks. In randomized order and     with 4 week wash out intervals each subject will receive all six different diets. Three day     food records will be used to measure total fructose and glucose intake. During the low     fructose diet subjects will be instructed to avoid nutrients containing fructose aiming at     consumption of less than 1g fructose/d. During the moderate fructose diet subjects will     receive 3x13.3g of fructose or glucose, respectively. High fructose diet subjects will     receive either 3x26.7g/d of fructose, 3x 26.7g/d of glucose or 3x 26.7g/d of sucrose in the     form of three daily soft drinks taken together with the three main meals.      75 g oral glucose tolerance testing will be performed and composite insulin sensitivity index     will be calculated The presence of phosphorylated fructose metabolites in plasma will be     measured by targeted LC-MS/MS. In addition, metabolite biomarkers in plasma will be screened     by untargeted metabolite profiling using both LC-MS and GC-MS. In a subgroup of 10 subjects     an euglycemic hyperinsulinemic clamp will be performed using [6,6- 2H2]glucose.      Thus, the lipogenic potential of fructose in humans will be compared with isocaloric amounts     of glucose. Particularly, the question whether lipogenic effects are continuously dose     dependent or whether there is a lipogenic shunting and if yes, at what level of ingested     fructose will be addressed.   "
241647|NCT01021982|"     Objective perimetry can better monitor visual field defects in RP and Glaucoma patients than     conventional subjective perimetry.The PLR ( Pupil Light Reflex ) of the short and long wave     ratio should be significantly higher in areas of visual field defects in RP and Glaucoma     patients.   "
241648|NCT01021995|"     Extracts produced from Echinacea purpurea are traditionally used for the prevention and the     acute treatment of influenzal infections like the common cold. The aim of this clinical study     is to assess clinical safety and efficacy of a treatment with Echinacea in comparison to     placebo. 750 healthy subjects with a history of equal or more than 2 cold episodes per year     will be recruited during October and November 2009 and will be treated with either Echinacea     or placebo over a period of 4 months.      Throughout the study period adverse events (AEs) and adverse drug reactions (AEs with at     least a possible causal relation to the treatment) will be recorded.      Common cold related symptoms will be recorded in a daily diary.   "
241649|NCT01022008|"     Context. Faciocraniosynostoses present with an insufficient growth of the craniofacial     skeleton due to premature fusion of skull and facial sutures. There are prenatal conditions     with functional (risk of raised intracranial pressure) and morphological consequences     (exorbitism, and impairment of upper respiratory airways), the severity of which justifies an     early surgical treatment based on craniofacial osteotomies and osteodistraction techniques.      Distraction techniques were started in our unit eleven years ago, and never ceased to be     modified: Recent improvements allowed better correction of exorbitism and therefore reduction     of visual risks. But the improvements of the respiratory function remain insufficient. The     initial evaluations of the respiratory functions were based on blood oxygenation monitoring,     and showed real improvement. But we have routinely screened our patients with complete     polysomnography examinations for the past year, and this has always revealed the existence of     severe sleep apnea syndromes that we fail to correct completely, although there were slightly     improved.      The aim of this PHRC protocol is :        -  the qualitative and quantitative improvement of the respiratory status with a reinforced          task force group including the specialists in genuine multidisciplinary approach.        -  A modification of the surgical technique including modifications of the existing          distraction devices, an increased number of implanted devices, and maybe a change in the          surgical strategy.   "
241650|NCT01022021|"     Patients with certain types of cancer require treatment with very high doses of chemotherapy.     A side effect of high chemotherapy doses is damage to the bone marrow where our blood and     immune system cells are produced.      Stem cells (or progenitor cells) are the source of all blood cells. They are formed in the     bone marrow (the spongy cavity in the center of large bones). The stem cells receive signals     that direct them to become red cells, white cells or platelets. This happens before they are     released into the blood stream. Stem cells circulating in the blood stream can be collected     through a process called apheresis or stem cell collection. The cells are then processed     and frozen to preserve them. After chemotherapy has been given the stem cells are thawed and     given back intravenously (IV: into the vein), like a blood transfusion. The stem cells in the     collection will find their way back into the bone marrow space and, after a few days, will     start to produce the blood and immune cells as they normally would. Having your own stem     cells collected and returned to you later is called an autologous transplant.      Non-Hodgkin's lymphoma is a disease in which malignant cancer cells form in the lymph system.     Autologous stem cell transplantation is the standard of care for a chemo-sensitive relapse in     patients with large cell lymphoma that has spread.      Bendamustine works by blocking the growth of cancer cells. It is used for the management of     chronic lymphocytic leukemia and follicular lymphoma. Bendamustine in addition to rituximab     (BR) is used in several trials in patients with lymphoma with encouraging results. Adequate     peripheral blood stem cell (PBSC) collection is a pre-requisite for high dose therapy     followed by cell transplantation in patients with relapsed lymphoma. Exposure to previous     multiple chemotherapy and radiation treatment may lead to poor mobilization of PBSC. It is     not known whether pre-treatment with bendamustine will adversely affect the process of PBSC     mobilization and harvest. On the other hand, it is assumed that high dose alkylating agents     like cyclophosphamide may actually help in breaking the bond between stem cells and the     stromal cells in the marrow cavity and hence may lead to a better mobilization of PBSC.   "
241679|NCT01022398|"     The purpose of this project is to determine if Vitamin D supplementation [10,000     international units of cholecalciferol (vitamin D3) by mouth weekly] will decrease the rate     of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of     muscle ache/pain due to statin therapy.   "
241651|NCT01022034|"     No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external     full‐thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that     recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy.      Method: This is a multicenter randomized non‐inferiority trial. Eligible patients were     randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal     surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery     with mobilization and pexy. Sigmoid resection was not randomized and was added in the     presence of constipation. The endpoint was recurrence rates defined as presence of external     FTRP after surgery. A pre‐RCT meta‐analysis suggested a sample size of 251 patients based on     a 15% expected difference in the 5‐year cumulative recurrence rate. Recurrence‐free curves     will be generated and compared using the Kaplan‐Meier method and log‐rank test, respectively.     A Bonferroni adjustment was used. An adjusted p value of <0.01 was considered significant.   "
241652|NCT01022047|"     To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by     means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.   "
241687|NCT01022502|"     To compare the efficacy and safety of refined indigo naturalis ointment with that of crude     ointment in treating psoriasis.   "
241655|NCT01022086|"     Herceptin has shown significant improvement in breast cancer therapy and improved survival of     patients over-expressing the HER-2 protein by 50%. However, Herceptin has shown to negatively     affect the heart, and frequent heart monitoring with multiple gated acquisition (MUGA) scans     is required. MUGA scans use radiation and are not very accurate. This study will use cardiac     magnetic resonance images (CMRs) to evaluate heart function and compare to MUGA scans in     patients receiving Herceptin for early-stage breast cancer. In addition, novel biomarkers     will also be assessed at the same time to help identify possible patients at risk for     developing heart toxicities.   "
241656|NCT01022099|"     Evaluation of the component position and kinematics after navigated and conventional Total     Knee Arthroplasty.   "
241657|NCT01022112|"     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284     compared with placebo in patients with type 2 diabetes.   "
241658|NCT01022125|"     The purpose of this study is to compare the levels of TMC435 in the blood circulation after     intake of 2 tablet formulations with the level of TMC435 in the blood circulation after     intake of a capsule formulation. The trial will also evaluate levels of TMC435 in the blood     circulation after intake of the capsule formulation fasted or following a meal.   "
241659|NCT01022138|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Treating a patient's T     cells in the laboratory may help the T cells kill more tumor cells when they are put back in     the body. Giving laboratory-treated T cells after chemotherapy may be an effective treatment     for breast cancer.      PURPOSE: This phase II trial is studying how well giving laboratory-treated T cells after     second-line chemotherapy works in treating women with HER2/neu-negative metastatic breast     cancer.   "
241660|NCT01022151|"     Early postoperative recovery of neurologic and cognitive functions is especially advantageous     after fast-tracking ambulatory procedures to hasten home discharge after surgery.1 It is well     known that volatile anaesthetic agents may generate adverse postoperative cognitive effects     and even traces of it may affect task performance in healthy volunteers.2Hence, rapid     elimination of the volatile anaesthetics may help reduce postoperative confusion and     cognitive impairment in surgical patients by facilitating a faster recovery from general     anaesthesia.3 Sevoflurane has been advocated for the routine anesthesia for ambulatory     surgery patients. It activates adenosine A1 receptors in primary rat hippocampal cultures     through the liberation of adenosine secondary to the interaction of with adenosine transport     or key enzymes in adenosine metabolism.4 However; sevoflurane anaesthesia is associated with     slower emergence and delayed early postoperative cognitive recovery than desflurane5 and     xenon2 anaesthesia.      Aminophylline, which is a hydrophilic cyclic adenosine mono-phosphate (cAMP) dependent     phosphodiesterase inhibitor has been used for long time to antagonize the sedative effects of     morphine, diazepam, and barbiturates.6-7Aminophylline in doses of 2-5 mg/kg shortens the     recovery from sevoflurane anaesthesia and improves bispectral index scores (BIS) with     concurrent increases in heart rate which might have a detrimental effect in patients with     ischaemic heart disease.8-11However, the use of smaller doses of 2-3 mg/kg is associated with     less increases in heart rate. 10-11 The use of 1 mg/kg of Doxapram is comparable to 2 mg/kg     of aminophylline in improvement of early recovery from sevoflurane anaesthesia secondary to     its central nervous system stimulating effect rather than increased ventilatory elimination     of sevoflurane.11 Currently, there is no available published studies have investigated the     effects of either theophylline or doxapram on early postoperative cognitive recovery after     balanced anaesthesia with sevoflurane.      We hypothesized that the use of small doses of aminophylline [2-3 mg/kg] may be comparable to     larger doses in improvement of the early postoperative cognitive recovery from sevoflurane     anaesthesia with associated non-significant increases in heart rate.      The present study investigated the effects of 1 mg/kg of doxapram, and 2, 3, 4, and 5 mg/kg     of aminophylline on the early postoperative cognitive recovery using the Short Orientation     Memory Concentration Test (SOMCT), response entropy (RE) state entropy (SE), difference     between RE and SE (RE-SE), end-tidal sevoflurane concentration, haemodynamics, the times to     eyes opening and to extubation and degree of sedation after sevoflurane anaesthesia in     patients undergoing ambulatory surgery.   "
241661|NCT01022164|"     To study the Safety and Efficacy of the use of fibrin glue in vitreoretinal surgery   "
241662|NCT01022177|"     The purpose of this study is to determine the influence of specific eye acupuncture to the     ocular microcirculation in diabetic and healthy subjects.   "
241663|NCT01022190|"     The purpose of the study is to determine whether Arcoxia is effective in preventing     heterotopic ossification after total hip arthroplasty.   "
241664|NCT01022203|"     The study is designed to evaluate the efficacy of a novel couple-based treatment for PTSD,     called Structured Approach Therapy, to decrease PTSD and improve the marital and social     functioning of Iraqi war Veterans and their partners. The effectiveness of couples therapy     will be compared with the effectiveness of a couple-based educational intervention.   "
241665|NCT01022216|"     The purpose of this study is to determine whether a bioelectric wound dressing, used in     conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of     diabetic and pressure ulcers of the foot.   "
241676|NCT01022359|"     This study aims to compare two available types of central venous haemodialysis catheters     (lines) - CVCs, and will examine how easy they are to insert, complications, blood flow on     dialysis over time, line loss, line clotting and infective events. It will examine whether     the LifeCath type of CVC can deliver high blood flow rates from first use after insertion and     equivalent function and complication rate to the Tesio type of CVC that is in use in our     centre already. Complications relating to dialysis access make up 30% of admissions for     haemodialysis patients and so this is a study that could benefit patients and their care     providers.   "
241677|NCT01022372|"     Our aim was to evaluate the efficacy of examining endometrial biopsy specimens for nerve     fibers as a diagnostic test for endometriosis and endometrioma in a double-blind comparison     with diagnostic laparoscopy.   "
241666|NCT01022229|"     The purpose of this study is to investigate the use of a natural health product, as compared     to placebo (an inactive substance), in managing the symptoms of ADHD. The natural health     product contains the nutrients zinc, magnesium, vitamin B6 and vitamin C. Each of these     nutrients has some evidence to suggest that children with ADHD might be lacking them. As     such, children with ADHD might benefit from supplementing their diets with these nutrients,     especially ADHD children who have below average levels.      This study will measure whether the severity of ADHD symptoms is greater in children with low     levels of zinc, magnesium, and vitamin B6, and whether the severity of ADHD symptoms will     decrease with supplementation of these nutrients. This study will also monitor for any     adverse reactions or side effects from taking these nutrients in children.      Although these natural health products are commercially available, the use of them as a     supplement or placebo in this study has been approved for use in this study by the Natural     Health Products Directorate of Health Canada.   "
241667|NCT01022242|"     The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients     with flexor tendon injury in zone I or II.   "
241668|NCT01022255|"     This phase I study will evaluate the safety and tolerability of an autologous idiotype     vaccine manufactured by magnICON technology for patients with relapsed follicular lymphoma     who are in complete or partial remission following non-antiCD20 containing salvage therapy.     Data in terms of idiotype-specific immune responses will also be obtained.   "
241688|NCT01022515|"     Pheochromocytoma or paraganglioma are tumors generating hypertension as a symptom. Different     biological tests are currently available to diagnose these tumors. However, they all lack     specificity since they do not distinguish cases of hypertension without pheochromocytoma or     paraganglioma. To improve the diagnostic specificity of these tumors, the investigators are     testing a new marker called EM66.   "
241924|NCT01010672|"     The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to     patients with metastatic bone or soft-tissue sarcoma in Japan.   "
241669|NCT01022268|"     This proposal represents a unified programme supported by both clinical and academic staff in     the Departments of Paediatrics at Imperial College and St Mary's Hospital. St Mary's Hospital     is the hub of a paediatric network for West London, and forms part of the Paediatric     Intensive Care Network for the London region, with potential access to a population of 3     million children.      We aim to improve diagnosis and understanding of children with infectious, inflammatory and     allergic conditions. Our study will establish well-characterised cohorts of patients with     defined conditions, in whom microbiological and patient samples will be used to understand     the contribution of genetic background, differential gene expression, proteomics and the     pathogen type to the disease process.      Unwell children coming to St Mary's hospital through any route will be invited to join the     study. Entering the study will entail the child having blood taken for research purposes in     addition to the clinically indicated tests. We will also recruit well (control) children who     are having blood tests performed for elective purposes, such as surgery.      In addition, children presenting with an illness that is likely to have an infectious     aetiology will also have samples collected for microbiological diagnosis. Those samples taken     for ordinary diagnostic purposes (such as blood, urine, CSF, bronchoalveolar lavage (BAL)     fluid or nasal brushings for epithelial cell cultures) would also be used for     state-of-the-art diagnostic techniques, in order to maximise the likelihood of confirming a     microbiological diagnosis. Where healthy, uninfected children are having invasive procedures,     such as lumbar punctures, we would aim to recruit these children as controls and collect     biological samples such as CSF samples.      This bid addresses the need for translational research in paediatrics, by building on the     world-class basic science and clinical paediatric base at Imperial College and St Mary's     Hospital.   "
241670|NCT01022281|"     To compare the Retina Nerve Fiber Layer thickness, measured with Scanning Laser Polarimetry     in subjects with exfoliation syndrome and normal controls and to evaluate the value of     scanning laser polarimetry in the early diagnosis and management of exfoliative glaucoma   "
241671|NCT01022294|"     To assess the analgetic effect of nitrousoxide-oxygen inhalation on pain perception in 12-15     years old children from 1) the dental pulp; 2) the masseter muscle; 3) the skin on the upper     lip   "
241672|NCT01022307|"     The investigators propose to develop quantitative automated lesion detection (QALD)     procedures to identify brain damage following traumatic brain injury more accurately than is     possible with a normal magnetic resonance imaging (MRI) scans. These procedures require about     1 hour of imaging in an MRI scanner. Subjects will also undergo about 2 hours of cognitive     tests. The investigators will compare the results of the cognitive tests with those from MRI     scanning to determine what brain regions are responsible for superior performance and for     performance decrements.   "
241673|NCT01022320|"     -  Describe blood pressure changes on patients with OSA treated with lateral pharyngoplasty        -  Compare the mean of systolic and diastolic blood pressure in 24 hours, average systolic          and diastolic pressure during daytime and night and changes in the nocturnal decrease.   "
241674|NCT01022333|"     Women with a BRCA1 mutation face a lifetime risk of breast cancer of approximately 70% and a     lifetime risk of ovarian cancer of approximately 40%. A number of potential anti-cancer     nutrients have been proposed, however, it is important that diet supplements be evaluated     prior to general recommendation.      The risk of breast and ovarian cancer in carriers of a BRCA1 mutation might be lowered by     some nutritional supplements. For example, green tea, broccoli and vitamin D are of potential     interest. One dietary supplement that is thought to have potential for BRCA1 carriers is     diindolylmethane (DIM), which is an active ingredient in broccoli and other green vegetables.     DIM - is found in vegetables like broccoli and is available as a supplement in health food     stores. The investigators think that DIM may increase the production of the normal copy of     BRCA1 and offset the effect of the mutation.      The purpose of this study is to determine that there is a potential for oral DIM     supplementation to result in the increased production of the BRCA1 protein in BRCA1 mutation     carriers. The results of the study will also serve as an evaluation of the current use and     success of preventive strategies for BRCA1 mutation carriers.   "
241675|NCT01022346|"     This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety     and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN     associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous     injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be     made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5     years.   "
241678|NCT01022385|"     The aim of the proposed study is to compare prospectively two methods of small bowel     preparation prior capsule endoscopy study, the effect on the cleanliness and the quality of     visualization after two protocols of preparation: a 12 hour fast only versus 24 hour of a     very low residual diet (ENSURE, Abbott Laboratories, Israel) + 12 hour fast.   "
241681|NCT01022424|"     ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral     administration of OPC-41061 at doses of 15 mg twice daily (morning and evening).     Administration will be continued until the time of manufacturing and distribution approval of     OPC-41061 for ADPKD in Japan.   "
241682|NCT01022437|"     This study is designed to evaluate the effectiveness of geranium oil and its components in     the relief of numbness and the restoration of sensations.   "
241683|NCT01022450|"     1. Analyze the various causes of breakdown of muscle fibers in hospitalized patients.        2. Analyze the characteristics of these patients in Taiwan (including the drugs history,          risk factors and the incidence of complications).   "
241689|NCT01022528|"     The objective of the study is to examine the effect of the addition of intravenous     dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid     consumption, pain scores, fatigue, and recovery in patients undergoing gynecological surgery     with laparotomy under general anesthesia.      This is a dose finding study with two different doses (0.1 mg/kg vs. 0.2 mg/kg) of     dexamethasone to find out the optimal efficacious dose of dexamethasone with minimal side     effects.      Dexamethasone has anti-inflammatory, immunomodulatory, and analgesic effects; and is superior     to placebo in providing post-operative pain control, lower analgesic consumption, prevention     of postoperative nausea and vomiting, lesser post-operative fatigue, and better recovery     profile. No dose response study has been done. The investigators hypothesize that a higher     dose of dexamethasone may have an incremental beneficial effect.   "
241690|NCT01022541|"     To evaluate the overall response rate of patients with previously untreated unresectable     liver-only metastases from colorectal cancer treated with neoadjuvant capecitabine and     oxaliplatin plus bevacizumab.   "
241691|NCT01022567|"     Appendicectomy has been the treatment of acute appendicitis for over a hundred years.     Appendicectomy, however, includes operative and postoperative risks despite being a routine     operation. At the same time other similar intra-abdominal infections, such as diverticulitis,     are treated with antibiotics. There have been some encouraging reports on successful     treatment of appendicitis with antibiotics and it has been estimated that operative treatment     might be necessary for only 15 - 20 % of patients with acute appendicitis.      The aim of this randomized prospective study is to compare operative treatment (open     appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before     randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of     the study is that the majority of patients with uncomplicated acute appendicitis can be     treated successfully with antibiotics and unnecessary appendicectomies can be avoided.   "
241692|NCT01022580|"     The purpose of this study is to determine if late doses of Infasurf surfactant given when     patients are receiving inhaled nitric oxide will interact to improve surfactant function and     increase survival without BPD in treated infants.   "
241693|NCT01022606|"     Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH)     profile   "
241694|NCT01022619|"     The aim of the present study is to establish, using polysomnographic criteria and prospective     nature, whether sleep apnea in pregnancy is more prevalent in women with high risk     pregnancies including preeclampsia, gestational diabetes, and pre-mature contractions, and to     determine the effect of sleep disordered breathing in pregnancy on fetal outcome. The     investigators' hypothesis is that sleep-disordered breathing is more prevalent in women with     high risk pregnancy compared to those with uncomplicated pregnancy.   "
241695|NCT01022632|"     The purpose of this study is to find the effect of commonly used nutraceutical curcumin (     extract of Curcuma longa, commonly called 'Haldi' in Hindi) in patients of depression.   "
241696|NCT01022645|"     The study is being done in order to gain information on the most suitable types of birth     control in women who recently had gestational diabetes, or diabetes diagnosed during     pregnancy. The intrauterine device (IUD) is a highly effective form of birth control. It is     inserted into the uterus and prevents pregnancy for either 5 or 10 years, depending on the     type of IUD (hormone-releasing or copper). The hormone-releasing IUD works for 5 years and     releases a hormone called a progestin into the uterus. The copper IUD contains no hormones     and works for 10 years. The IUD is an excellent form of birth control postpartum, but it is     unknown if the hormone-releasing IUD will affect blood sugars and increase a woman's risk of     becoming diabetic when she's not pregnant. The hypothesis is that the hormone-containing IUD     will NOT increase blood sugars, so women who use the hormone-containing IUD will have similar     blood sugars to those who use the copper IUD or have had their tubes tied (no hormones).   "
241697|NCT01022658|"     Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of     cardiovascular risk. The aim of this pilot study is, in type 2 diabetic patients now     requiring insulin, to compare the effects of improving glycemic control on these parameters     with 3 different insulin regimens which will act especially at fasting or in post-prandial     periods or both. Non invasive explorations will be performed before randomization and after 4     to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.   "
241698|NCT01022671|"     A phase II study is conducted to determine the efficacy and safety of a single agent     Camtobell inj.(belotecan) on a weekly schedule in locally advanced or metastatic non-small     cell lung cancer patients previously treated with chemotherapy. The usefulness of the this     regimen is evaluated by response rate, median survival time, progression free survival and     duration of response.   "
241699|NCT01022684|"     Vascular inflammation is a key factor in both the pathogenesis and outcome of     atherosclerosis. Various inflammatory markers such as LpPLA2,MCP-2 and hsCRP are well-known     prognostic factors for the cardiovascular event.      18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for     identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore,     the purpose of the study is to demonstrate the correlation between various inflammatory     markers and vascular inflammation detected by 18FDG-PET.   "
241723|NCT01022996|"     This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that     has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after     gemcitabine- or vinorelbine- or vinblastine-based treatment.   "
241724|NCT01023009|"     After an uneventfully small gauge vitrectomy we don´t think is necessary to occlude the eye     for 24 hours   "
241726|NCT01023035|"     The current trial is designed to prospectively explore the safety of erythropoietin use for     the treatment of anemia during boceprevir plus peginterferon alfa-2b/Ribavirin (PEG2b/RBV)     therapy and to assess its relationship to efficacy. All participants in this trial will be     treated with the triple combination of boceprevir plus PEG2b/RBV. If a participant becomes     anemic during treatment, the participant will be randomized to one of two therapeutic     strategies for management of anemia (erythropoietin use versus RBV dose reduction).   "
241700|NCT01022697|"     Fear of full stomach when emergency general anaesthesia is required is the origin of     fastening when giving birth. This behaviour does not warranty perfect security for the     general anaesthesia. In addition, well being for women and new born is affected. Giving birth     is finally compared to a sportive competition with high-energy needs. As Intravenous energy     intake is not regulated by physiologic digestion, it can induce metabolic disorders for the     mother that can be amplified for the foetus.      Oral glucose drinks could offer some benefits:        -  gastric acidity would be decreased without significant increase in volumes.        -  energy intake would further more active and more efficiency labour        -  an increase in foetus well being      However, it has never been shown yet that such behaviour could offer those benefits. Also, it     seems that there is not more vomiting, but most of the studies compared oral glucose intake     to waterborne intake with the same volumes The expected efficacy is a reduction in labour     duration and a reduction in percentage of extraction. Previous studies said that the lack of     statistical power due to small number of subjects caused the absence of statistical     significant relationship.      In addition, even though newborn have less acidosis, there is no clinical relationship     proven.      The investigators propose a randomised multicentre study to assess efficacy of oral glucose     drinks in comparison to traditional fastening when giving birth.      Main objective is to significantly reduce instrumental extraction rates. 5400 women will be     included in the study in 2 years.   "
241701|NCT01022710|"     This study measures sounds produced by the sensory receptors of the inner ear called hair     cells. These sounds are called otoacoustic emissions and one special case the investigators     are studying are called distortion product otoacoustic emissions (DPOAEs) produced by     presenting two tones to the ear. If the ear is damaged by noise exposure DPOAEs are reduced.     In this study the investigators are attempting to improve the DPOAE test by adding a third     tone to make the test more frequency specific. Whether the third tone helps will be     determined by comparing DPOAEs collected with and without the third tone to clinical     audiograms. If the addition of the third tone helps then the investigators expect DPOAEs     tracked as a function of frequency (DP-grams) will more closely match the clinical     audiograms.   "
241702|NCT01022723|"     To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to     correlate the circulating titre with response and progression.   "
241703|NCT01022736|"     This open label investigation is to determine whether cardiopulmonary bypass affects plasma     gabapentin concentration after preoperative administration in the setting of cardiac bypass     surgery. Following signed informed consent, 16 patients scheduled for cardiac bypass surgery     will be given gabapentin (600mg, oral) 1 hour prior to surgery, 1 hour following extubation     and then every 8 hours for a total of 4 doses. Plasma gabapentin levels will be measured     prior to induction, prior to bypass, 10 min into the bypass procedure, 10 minutes before     separation from bypass, 30 minutes following bypass and then before and 2 hours following     each of the next 3 doses of gabapentin. Pain scores, sedation scores, side effects and     morphine equivalents will be documented for one day following surgery.   "
241704|NCT01022749|"     The primary purpose of the study is to compare the efficacy and safety of influenza vaccine     in patients with inflammatory bowel disease (IBD) receiving immunosuppressive therapy with     patients not receiving immunosuppressants .      The main objective of the study is to evaluate the humoral immunogenicity of influenza     vaccination in patients with IBD   "
241705|NCT01022762|"     This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood     glucose lowering effect and the safety profile of repaglinide given alone compared to     gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated     with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of     repaglinide on the phases of insulin secretion as a subgroup study.   "
241706|NCT01022775|"     The purpose of this study is to determine wether dynamic humeral centering is effective in     patients with impingement syndrome of the shoulder   "
241707|NCT01022788|"     This study will develop, implement and evaluate the effectiveness and cost of interventions     at community level (focussed on a community-based health worker) and of health system     strengthening on newborn survival in rural southern Tanzania.      Objectives        1. To develop and document a community-based package for improved newborn care, focussed          around interpersonal communication through home visits in pregnancy and the early          neonatal period .        2. To develop and document a quality improvement package for antenatal, intrapartum and          postnatal care in health facilities.        3. To implement these strategies for improved newborn survival in such a way as to be both          sustainable and scaleable at national level.        4. To monitor understanding of, and attitudes related to, neonatal care and survival from          both health provider and community perspectives in areas with and without the          interventions.        5. To measure incremental costs and cost savings to the health sector and society          associated with the interventions, and to predict the cost of integrating the programme          into routine health service provision and of scaling-up        6. To strengthen Tanzania's capacity to develop, implement and evaluate interventions to          improve neonatal survival.        7. To estimate the effect of the interventions on newborn survival and household behaviours          related to newborn health.      Study design & methods. The interventions will be implemented in parts of Lindi and Mtwara     regions. The health system quality improvement package will be implemented throughout the     area and evaluated using a before-after comparison. The community intervention will be     implemented initially in a randomly-chosen half of all wards (a ward is an administrative     sub-area of a district). Implementation will be led by existing front-line health staff.     Evaluation will include a health facility survey and a household survey to assess contacts     with the agents of change, key behaviours and newborn survival in the community.   "
241708|NCT01022801|"     To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA     levels by PCR (log10 copies/mL) at Week 22   "
241709|NCT01022814|"     In the final months of pregnancy, women need to know whether their 'water is broken'     necessitating a race to the delivery room, or whether pressure of the foetus on their bladder     has caused them merely to pass urine. They may also have faced the same dilemma on many     occasions much earlier in the pregnancy. With this development the investigators will provide     them with an immediate answer to this critical question.   "
241737|NCT01023178|"     To directly compare the safety (by laboratory evaluation) and efficacy (feminization and     growth) of three commonly used estrogen preparations in adolescent patients with ovarian     failure, either due to congenital causes (Turner syndrome) or medical therapies. We     hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable     safety profile in comparison with conventional oral estrogen replacement.   "
241727|NCT01023048|"     Gene Security Network has developed a novel technology called Parental SupportTM (PS) which     is used for Preimplantation Genetic Screening/Diagnosis (PGS/D) during in vitro fertilization     (IVF). This technology allows IVF physicians to identify embryos, prior to transfer to the     uterus, which have the best chance of developing into healthy children. The purpose of this     study is to validate clinical use of PS to detect specific genetic mutation(s) known to cause     severe inheritable diseases in embryos produced by at-risk couples. This may be done while     simultaneously testing these embryos for aneuploidy. This study will allow for first of its     kind commercial PGS/D testing to detect disease-associated genetic mutations together with     aneuploidy screening.   "
241710|NCT01022827|"     The investigators investigated the effect and predictors of effectiveness of massage in the     treatment of patients with posterior shoulder stiffness. This is a randomized controlled     trial study- massage and control (hand touch) two times a week for 4 weeks. A total of 60     patients with posterior shoulder tightness were randomized into 2 groups; 52 of them     completed this study (29 for the massage and 23 for the control). Patient sex, age, body mass     index, glenohumeral internal rotation range of motion (ROM), duration of symptom, functional     status, and muscle stiffness were recorded. Additionally, for the massage group, patients     with glenohumeral internal rotation improvement of 20 degrees after massage were considered     responsive, and the others were considered nonresponsive. The influences of the     aftermentioned factors on the effectiveness of massage were analyzed by multivariate     logistric regression. The overall mean internal rotation ROM increased significantly after     massage (from 31.9° to 54.9°; P < 0.001) compared to the control (from 28.7° to 34.9°; P >     0.05). There were 22 patients in the responsive group and 7 in the nonresponsive group. Among     the factors, duration of symptoms, FLEX-SF score, and posterior deltoid stiffness were     significant predictors of effectiveness of massage. Massage was an effective treatment for     subjects with posterior shoulder stiffness, but was less effective in patients with longer     duration of symptoms, higher functional limitation, and less posterior deltoid stiffness.   "
241711|NCT01022840|"     The primary hypothesis is improved postoperative analgetic quality using S-Ketamine,     particularly in patients suffering from chronic pain.   "
241712|NCT01022853|"     The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD)     in terms of safety and tolerability of BI 6727 in combination with fixed dose BIBF 1120, in     patients with advanced or metastatic solid tumours.   "
241713|NCT01022866|"     At the Falls Prevention Clinic, each subject receives a comprehensive assessment of his or     her individual risk factors for falling in addition to a comprehensive medical examination.     Recommendations and appropriate followup tests and referrals are ordered for patients on an     individual basis.      Essential for medical advancement is the inquiry into information collected from medical     records of older adults at high risk of falls and fracture. On such example is a     retrospective chart review we conducted among patients who sustained a hip fracture [14]. The     database we propose will provide novel insight into the identification of individuals at high     risk for falls, key predictors of falls and associated mortality, morbidity, health related     quality of life and healthcare resource utilization. In summary, our database will enable us     to assess and improve quality of care, service delivery, patient outcomes, patient reported     outcomes and track economic burden.   "
241714|NCT01022879|"     The use of topical anesthetics is a non invasive option avoiding local or general anesthesia     in small gauge vitrectomy without causing intolerable pain   "
241715|NCT01022892|"     The purpose of this study is to support the suspected expectation that Contrast enhanced     Ultrasound (CUS) detects all endoleaks that have been detected by Computed Tomography (CT),     and also find a number of leaks missed by CT.      The investigators' primary goal is to detect no difference between CT and CUS and provide     evidence that CUS is a possible alternative to CT.   "
241716|NCT01022905|"     The objective of this study is to assess vaccine responses to novel adjuvanted influenza     A(H1N1) vaccines in patients at high risks of influenza A(H1N1) complications.   "
241717|NCT01022918|"     Treatment of glioblastoma (GBM) is based on surgery when possible, and chemoradiation with     temozolomide, which became a standard since the EORTC study (Stupp, 2005). However, the     prognosis of unresectable GBM remains poor despite chemoradiation with an estimated 10 month     median survival, in the range of the comparable patients in the RPA class V from the EORTC     study (Miramanoff, 2006).      Vredenburgh et al. from the Duke University (Durham, NC) reported at ASCO 2006 (fully     published in J Clin Oncol, 2007) a 57 % unexpected response rate using a     bevacizumab/irinotecan schedule in patients with relapsed GBM or grade 3 astrocytomas. This     unusual high response rate, sometimes with major and sustained responses, was confirmed by a     cooperative french study of ANOCEF (Guiu et al., 2008). Such a major improvement of treatment     effectiveness lead ANOCEF, which federates most of the active neuro-oncology teams in France,     to propose a neo-adjuvant and adjuvant bevacizumab-based chemotherapy framing a standard     temozolomide-based chemoradiation with the aim to improve the prognosis of unresectable GBM.      The bevacizumab/temozolomide combination as neo-adjuvant is presently being evaluated by the     Duke University. We believe that an ambitious comparison of the     bevacizumab/irinotecan-schedule with the ''standard'' temozolomide-based chemoradiation is a     fascinating challenge to improve the treatment of this awful disease.      The ANOCEF proposal '' Evaluation of the irinotecan/bevacizumab association as neo-adjuvant     and adjuvant treatment of chemoradiation with temozolomide for naive unresectable     glioblastoma. Phase II randomized study with comparison to chemoradiation with temozolomide''     has been successfully granted by INCA (Institut National du Fancer, France) through its     research program ( PHRC : Programme Hospitalier de Recherche Clinique). Implementation of     this program is now starting .   "
241718|NCT01022931|"     This study aims to identify clinical symptoms and outcomes, as well as response to anti-viral     treatment in children living in Geneva, with influenza A/ H1N1 infection during the current     pandemic.   "
241752|NCT01023373|"     The aim of the study is to value, in patients with chronic kidney disease and hypertension,     whether medical therapy plus interventional renal artery revascularization is superior to     medical therapy alone for the treatment of hemodynamically significant (>70%) atherosclerotic     renal artery stenosis, diagnosed by duplex doppler ultrasonography and confirmed by magnetic     resonance angiography, in terms of avoidance of the progression of renal damage, control of     hypertension and in reducing the cerebro and cardiovascular complications.   "
241753|NCT01023386|"     This study investigates the pharmacokinetics of YM155, identifies the metabolic profile of     YM155 and evaluates the safety and tolerability of YM155 after a 3-hour infusion in patients     with advanced cancer   "
241840|NCT01009580|"     This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to     compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects     with type 2 diabetes.   "
241719|NCT01022944|"     Rationale: Bacterial biofilms are defined as an assemblage of bacterial cells enclosed in a     self-produced glycocalyx matrix. Adherence on surfaces, and resistance to both antibiotic     treatments and host defenses are ones of the major clinical features of bacterial biofilms.     Hence, biofilm formations represent a serious clinical problem: they persist in human tissues     and play a role in a large number of chronic and resistant infections. It has been estimated     that more than 65% of all human bacterial infections involve biofilms. Recently, the     investigators have demonstrated the presence of mucosal bacterial biofilms in adenoid tissues     removed during routine adenoidectomy. Bacterial biofilms were visualized using Confocal Laser     Scanning Microscopy (CLSM) with a technique of double staining showing both the bacterial     cells and the glycocalyx matrix. Although this study clearly established that adenoids     tissues can harbour mucosal biofilms, the prevalence of 54% the investigators found suggested     that some groups of children may contain more biofilm formations than others. In an effort to     relate the findings of mucosal biofilm with the clinical presentation, the investigators have     designed the present work to compare the prevalence of mucosal biofilms in adenoidectomy     specimens in two groups: one group of children with chronic otitis media (COM) with effusion     versus another group of children without any COM, having adenoids removed for chronic     obstruction.   "
241720|NCT01022957|"     to describe evolution of Nephronophthisis   "
241721|NCT01022970|"     This study is designed to investigate the effects of a 12 week course of intravenous QAX576     6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of EoE patients     by 75% or greater when compared with baseline.   "
241722|NCT01022983|"     The purpose of this study is to investigate the safety and efficacy of Levosimendan given     preoperative to patients with heart failure undergoing noncardiac surgery.   "
241728|NCT01023061|"     This phase II trial studies the side effects and how well abiraterone acetate, prednisone,     and leuprolide acetate or goserelin before and during radiation therapy works in treating     patients with localized or locally advanced prostate cancer. Androgens can cause the growth     of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide     acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation     therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and     leuprolide acetate or goserelin before or together with radiation therapy may be an effective     treatment for prostate cancer.   "
241729|NCT01023074|"     The purpose of this study is to characterize the central auditory processing (CAP) deficits     that result from multiple sclerosis (MS).   "
241730|NCT01023087|"     Colistin is a relatively old antibiotic drug which its use has been abandoned through the     1970s because it was considered nephrotoxic.      Recently ( the last decade) it has been reappraised because multidrug resistant Gram negative     bacteria have emerged causing life threatening infections with no other good enough     treatment. Moreover, more controlled studies from the recent years show less toxic effect of     the drug.      The investigators' study is a prospective study comparing renal function in a group of     hospitalized patients with sepsis (infection) receiving intravenous treatment with Colistin     (antibiotics) with a control group which its patients receive other non nephrotoxic     antibiotics.      The investigators' study hypothesis is that patients receiving Colistin would have renal     function decline in higher rates than those seen usually in hospitalized patients in the     Internal medicine wards with sepsis.      Another goal of the study is to find correlation between Colistin levels in the plasma (after     Colistin reaches steady state) and nephrotoxicity seen during or after use of this drug.   "
241731|NCT01023100|"     This study will test the palatability of several different CP-690,550 oral preparations in     trained product tester healthy volunteers.   "
241732|NCT01023113|"     Lacunae in Knowledge No study is available in literature regarding visual field impairment in     proliferative diabetic retinopathy comparing conventional double frequency Nd:YAG panretinal     photocoagulation with PASCAL panretinal photocoagulation      AIMS & OBJECTIVE        1. To compare visual field impairment in conventional double frequency Nd: YAG panretinal          photocoagulation with PASCAL panretinal photocoagulation.        2. To examine the effect of these modalities of laser on macular edema      60 eyes of proliferative diabetic retinopathy will undergo humphery visual field analysis,and     optical coherence tomography before and after panretinal photocoagulation   "
241733|NCT01023126|"     Adherence to obesity treatment programs has been a limiting factor to good results in loosing     weight. This study aimed to verify if obese subjects submitted to a physical exercise program     and group psychotherapy would have a greater adherence, than obese people exercising only.   "
241734|NCT01023139|"     There are few studies that look at sustained weight loss in the adolescent population. This     study uses a multidisciplinary approach along with pharmacotherapy (use of Meridia)to     motivate and establish behavior changes in adolescents (12-18yo) during the first phase of     the study.      The second phase will have those who have lost at least 5% BMI to be randomized into one of     two groups. This first group will have no intervention and will be followed at 3 and 6 months     to assess for weight loss maintenance. The second group will continue on with monthly     behavior modifications and also be evaluated at 3 and 6 months.      The hypothesis proposed is that, 1)there will be sustained weight loss at the end of one year     in both arms as compared to baseline BMI, 2) and the arm with the behavioral therapy     intervention will be more successful than no intervention at weight loss maintenance.   "
241735|NCT01023152|"     The purpose of this study is to study the effect of remote ischemic preconditioning on acute     kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary     bypass.   "
241736|NCT01023165|"     The purpose of this study is to determine if restoring normal metabolic function in patients     with type 1 or type 2 diabetes can improve the impact of the consequences of diabetic     complications on the overall health and quality of life for diabetic patients.Patients are     treated once per week with intensive bolus intravenous insulin delivery mimicking normal     insulin secretions in a non diabetic individual. Baseline and periodic diagnostic tests are     performed and questionnaires completed to evaluate and monitor progress and outcomes.   "
241841|NCT01009593|"     The primary objective of this study is to assess the overall survival (OS) of oral linifanib     given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per     standard of care in subjects with advanced or metastatic HCC.   "
241738|NCT01023191|"     Healthy kidneys clean your blood by removing excess fluid, minerals, and wastes. When your     kidneys fail, harmful wastes build up in your body and your body may retain excess fluid.     When this happens, you need treatment to replace the work of your failed kidneys. This may be     with a dialysis machine using haemodialysis or with fluid in the abdomen or peritoneal     dialysis.      In peritoneal dialysis, a tube called a catheter is put in the abdomen wall and used to fill     your abdomen with a cleansing liquid called dialysis solution. The walls of your abdominal     cavity are lined with a membrane called the peritoneum, which allows waste products and extra     fluid to pass from your blood into the dialysis solution. These wastes and fluid are removed     from the body when the dialysis fluid is drained and replaced with a fresh solution.      The tubes or catheters used to exchange the fluid are currently positioned using a general     anaesthetic (with the patient awake) and an operation with a cut under the belly button.     Newer techniques using local anaesthetic (with the patient awake and the area numbed) and     requiring only a small cut in the skin have been used. No one has ever directly compared the     two techniques.      The investigators aim is to perform a direct comparison between the two techniques to look at     the complications and time required for surgery and length of hospital stay required. The     investigators will also look at the patients satisfaction and pain scores with each technique     to help gather evidence as to which is likely to be the best technique to use from now on.   "
241739|NCT01023204|"     The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given     weekly in patients with advanced or recurrent breast cancer   "
241740|NCT01023217|"     The presence of persistent inadequate or suboptimal virologic response is a strong risk     factor for viral resistance and breakthrough and also for disease progression of chronic     hepatitis B, and thus, a change in therapy is required. The combination of entecavir (ETV)     and adefovir (ADV) is a promising treatment for patients with lamivudine (LAM)-resistance who     show suboptimal response to the combination of LAM and ADV.      In this randomized, open labeled trial,the investigators will compare the efficacy of     continuation of ADV plus LAM versus switch to ADV plus ETV in adults with LAM-resistant     chronic hepatitis B who shows suboptimal response to the combination treatment of ADV and     LAM.   "
241741|NCT01023230|"     The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine     will be well-tolerated and induce hepatitis B virus (HBV)-specific virological and     immunological responses in chronic hepatitis B (CHB) patients.   "
241742|NCT01023243|"     The investigators propose to use a Natural Language Processing System (NLP) to provide an     initial baseline report for primary care patients at risk for diabetes and cardiovascular     complications that will include: a) evidence of foot exam documentation in the previous year;     b) use of aspirin for cardiovascular risk reduction; and c) tobacco use. As part of a     randomized trial, we plan to use a previously validated mailed survey (NCQA Provider     Recognition Program) that requests information on the last foot exam, use of aspirin and     tobacco. Patients who have been identified by NLP as not having had a foot exam will be     randomized into treatment and control arms. Both arms will receive an informational letter;     with a second mailing to nonresponders after one month, describing the key strategies for     effective patient-physician communication during the clinical encounter. The treatment arm     will also receive an informational letter and patient education brochure containing key     messages about the importance of regular foot examinations. NLP will be repeated after 6     months to compare the impact of the patient education materials.   "
241743|NCT01023256|"     GM-CSF is considered to have a key role in the initiation and progression of arthritic     inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy,     pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF,     in patients with active rheumatoid arthritis.   "
241744|NCT01023269|"     The study is designed to demonstrate that treatment with low level stimulation of the bladder     muscles reduces symptoms of urinary incontinence in comparison with no stimulation.   "
241745|NCT01023282|"     The study will evaluate the safety and tolerability of ACR325 in Parkinson disease patients     and evaluate the effect on levodopa induced dyskinesias.   "
241746|NCT01023295|"     The primary objective of this study is to examine effects of fosbretabulin tromethamine     (fosbretabulin) on PCV as reflected by a change from baseline in the number of polypoid     lesions on indocyanine green angiography (ICGA).   "
241747|NCT01023308|"     Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of     HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded     protein aggregates and triggers myeloma cell death. Combination of pan-DAC and proteasome     inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated     synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore,     clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat     and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and     manageable toxicity profile.      Given the medical need for improved treatment strategies for patients with previously treated     and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind,     placebo-controlled, parallel group Phase III study is to compare the results in     progression-free survival of 2 combination therapies, panobinostat with bortezomib and     dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously     treated MM who recurred after 1-3 prior lines of therapy   "
241748|NCT01023321|"     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)     and multiple (MD) oral dose of GLPG0555 compared to placebo.      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple     oral administration will be evaluated, and, if applicable, the maximum tolerated dose     determined.   "
241749|NCT01023334|"     The purpose of this study is to determine whether intraocular lidocaine increases patient     comfort during the different stages of MSICS while under topical anesthesia.   "
241750|NCT01023347|"     This is a randomized clinical trial of Paclitaxel (Genexol®) and Cisplatin versus Paclitaxel     loaded polymeric micelle (Genexol-PM®) and Cisplatin in advanced non small cell lung cancer.   "
241751|NCT01023360|"     Currently, drugs commonly used for antiplatelet are aspirin and clopidogrel when encountering     stroke or coronary heart disease. In this study, we would use VASP assay and     thromboelastograph with platelet mapping assay kit to evaluate the antiplatelet resistance in     general population and the relationship between clopidogrel and proton pump inhibitor.   "
241754|NCT01023399|"     The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain     Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus     amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate     plus amodiaquine implementation program and 24 months later.      The secondary objectives are Clinical and biological tolerability Evolution of gametocyte     carriage Proportion of patients without fever at Day 3 Proportion of patients without     parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite     sensibility to amodiaquine   "
243783|NCT01050660|"     The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC)     is related to the amount of parenteral (intravenous) fat administered to premature babies     until full enteral nutrition is achieved.   "
241755|NCT01023412|"     Major surgery is still associated with a high rate of postoperative morbidity despite     improved techniques in surgical management. Surgery-induced alterations of the immune system     are well described and may play a role in the genesis of postoperative complications. It has     been shown by several large scale clinical trials, that the use of immunonutrition in     postoperative cancer surgery, trauma and critically ill patients resulted in an improved     immunocompetence and/or reduced postoperatively infectious morbidity and/or length of     hospital stay.The pre-operative regimen was between 5 to 7 days of treatment. The aim of this     trial is to evaluate if a shorter administration of 3 days pre-operatively would be     beneficial as well.   "
241756|NCT01023425|"     To compare the clinical efficacy of donepezil between the naive group and the switching     group.   "
241757|NCT01023438|"     The purpose of the study is to assess whether primary care physicians may uptitrate     recommended drug therapies in stable heart failure patients if educational material and     specialist support including phone or mail consultation are provided   "
241758|NCT01023451|"     The purpose of this study is        1. To determine if Brain natriuretic peptide levels correlates with elevated tricuspid          regurgitation flow velocity levels in pediatric patients with sickle cell disease        2. To determine the role of age, gender, steady state hemoglobin and disease type on Brain          natriuretic peptide levels and pulmonary hypertension   "
241759|NCT01023464|"     To evaluate the effects of FID 114657 on tear film break-up time in dry eye patients.   "
241760|NCT01023477|"     The purpose of this study is to test the hypothesis that chloroquine will reduce the ability     of ductal carcinoma in situ (DCIS) to survive and spread. Participants will receive either     chloroquine standard dose (500mg/week) or chloroquine low dose (250mg/week) for 1 month prior     to surgical removal of the tumor.   "
241761|NCT01023490|"     The objective of this study is to check whether vitamin D will lead to a decrease in pain     intensity compare to placebo, in patients suffering from chronic pain.   "
241762|NCT01023503|"     The present project is aimed at describing the statins prescription pattern in Spanish     patients. It will also look into how adequate these prescriptions are accordingly to the     recommendations given in Treatment Guidelines and in the Summary Product Information.   "
241763|NCT01023516|"     The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in     symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD   "
241764|NCT01023529|"     The purpose of this study is to assess the effect of palliative pelvic radiation on symptoms     and quality of life among patients with incurable prostate and rectal cancer.   "
241765|NCT01023542|"     The primary objective of the trial is to evaluate efficacy and safety of delayed introduction     (up to 30 days post-transplantation in patients without signs of acute rejection that had     received an aIL-2 induction and MMF) of either cyclosporine or everolimus versus a 5-day     delay of cyclosporine in combination with MMF.   "
241766|NCT01023555|"     The purpose of this study is to determine whether the use of a single blood sample of 1cc in     an aerobic bottle will provide a better yield and time to positivity than 2 samples of 0.5 cc     in 2 (aerobic and anaerobic) bottles for blood cultures in neonates.   "
241767|NCT01023568|"     The purpose of this study is to compare the effectiveness of two novel videolaryngoscope     systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in     pediatric patients. The investigators primary hypothesis is that the use of videolaryngoscope     devices, Glidescope and Truview provide better laryngeal views in pediatric patients as     measured by Cormack and ehane (C&L) (1 to 4, 4 the worst), without increasing the time taken     to intubate (TTI), compared with direct laryngoscopy (DL).      The investigators secondary hypotheses are that the use of Glidescope and Truview PCD provoke     less hemodynamic response and fewer episodes of de-saturation in pediatric patients.   "
241768|NCT01023581|"     The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined     with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.   "
241769|NCT01023594|"     Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To     reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy.     There are two distinct methods of pancreatic stent insertion: internal stent and external     stent. There was few studies comparing these methods in preventing pancreatic fistula.     Furthermore, its long-term effect was not known enough. The purpose of this study is to     determine which is the best method in preventing pancreatic fistula and to investigate its     long term clinical outcomes.   "
241789|NCT01023854|"     The paravertebral block is an alternative in the analgesia epidural the major interest of     which lives in the catheterisation of the paravertébral space allowing to assure/insure an     one-sided continuous analgesia.      The main objective of the study is to bring to light the superiority of the continuous     paravertébral block, as a supplement to analgesia, in the care of the renal and\or adrenal     surgery by laparotomy at the adult in terms of consumption of morphine, with regard to the     classic analgesia classic.      The main assessment criterion is the consumption of morphine within first 24 postoperative     hours at the patients benefiting from a paravertébral continuous block besides the classic     systematic analgesia.   "
241790|NCT01008072|"     The methods of detoxification under general anesthesia have been criticized because of     limited data on safety and long-term follow-up. Premedication with buprenorphine has been     advocated to improve safety. In current study we want to evaluate the importance of     buprenorphine preparation in rapid opioid detoxification process, under general anesthesia.   "
241770|NCT01023607|"     Many trials suggested that lipid lowering therapy could significantly reduce cardiovascular     events. Enhancing stability of vulnerable plaque is probably the main reason by which statins     reduce adverse coronary events. The size of lipid core and the fibrous cap thickness (FCT)     are the major determinants of plaque vulnerability. So, it is very important to accurately     evaluate changes in plaque after stains therapy.      Previous reports suggested that intensive lipid lowering therapy provide more significantly     clinical benefit compared with moderate lipid lowering therapy.Such benefit may contribute to     the changes in following parameters: FCT, lipid arc(quadrants), TCFA, macrophage, plaque     disruption, and thrombus measured by OCT, and plaque burden and remodeling index by IVUS.      Current intravascular imaging modalities, such as optical coherence tomography (OCT) and     intravascular ultrasound (IVUS) can provide in vivo quantitative and qualitative information     of coronary plaques. However, there were few studies aimed at monitoring the progression of     coronary plaques in patients receiving statin therapy by OCT combined with IVUS.      Therefore, the study we designed were to compare the effect of the rosuvastatin 10mg,     atorvastatin 20mg and atorvastatin 60mg treatment on the changes in FCT and lipid core arc by     OCT and plaque burden by IVUS of coronary atherosclerotic plaques.   "
241795|NCT01008137|"     A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years)     to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's     H1N1 influenza A Vaccine (PANFLU.1) with Trivalent Inactivated Influenza Vaccine (ANFLU).   "
241963|NCT01016522|"     This research is being done to see if the ketogenic diet (which is high in fat and low in     carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (ALS) patients who are     fed through a gastrostomy tube. This is not a study to see if ketogenic diets are effective     in the treatment of ALS.   "
241771|NCT01023620|"     This study is being done to better understand why people with HIV who have taken drugs for     HIV begin to show abnormal changes in fat loss or fat gain in their bodies. This condition is     called lipodystrophy.      Patients who take medicine for HIV and who have lipodystrophy report loss of subcutaneous     (sc) fat from the arms, legs, and face and excess fat gain in the neck and truncal region.     They also more likely to have problems with insulin in the body, high fat levels in the blood     and diabetes. The reason that lipodystrophy develops is not fully understood although some     HIV drugs have are very likely the cause. The complications pose an increased risk of fat     blockage forming in the arteries making you more at risk for heart problems in the future.     Changes in body fat can cause physical discomfort and psychological distress. Management of     these problems can be a challenge for the patient's doctor.      The investigators propose data collection to determine if there is more than one reason why     this might happen in some people and not in others. Laboratory samples being collected: 1)     special imaging of the liver; 2) fat collected by needle from the mid thigh and mid-shoulder     areas; 3) blood samples to measure the virus, t-cells, fats, and other markers of how the     patient's body is handling the virus.      This study is being done because science does not fully understand why some patients with HIV     who take medicines for the virus have abnormal fat loss or gain and some do not. This     research study is intended to help us better understand why and how this happens.   "
241772|NCT01023633|"     Previous OPTIMOX1 study investigated the use of oxaliplatin discontinuation and     reintroduction in a novel stop-and-go strategy. Previously untreated patients were randomly     assigned to either FOLFOX4 administered every 2 weeks until progression (arm A) or FOLFOX7     for 6 cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7     for another 6 cycles (arm B). Data showed that there was no significant difference in median     progression-free survival (PFS) and overall survival (OS) between two arms. Furthermore, this     study showed lower Grade 3 neurotoxicity rate in arm B (17.9% vs 13.3%, P = 0.12).In order to     investigate the efficacy and feasibility of the novel Stop and go strategy in Chinese mCRC     patients, Prof. Shu Yongqian in JiangShu Province Hospital plans to conduct a randomized     controlled study to compare continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st     Line mCRC patients. To avoid the high oxaliplatin dosage related neurotoxicity, FOLFOX4     regimen is chosen in this study.   "
241773|NCT01023646|"     The purpose of this study is to determine the variability in glycemic index determinations     for individual foods and food combinations. The study will also evaluate the changes in     insulin and free fatty acid levels, plasma lipid and lipoprotein profiles, C-reactive     protein-a marker of inflammation and glycosylated hemoglobin- a marker of glucose metabolism     during a five-hour period after eating the food or foods. Additionally, supplementary data on     variation in oral sensation, habitual food intake, food preferences and genes mediating     sensory perception and dietary behaviors (supported by a grant from the Tufts Ross Aging     Initiative) will be related to the outcomes on the present study.   "
241774|NCT01023659|"     Bupropion and varenicline are indicated for smoking cessation. The objectives of this study     are two-fold: (1) to explore the logistic feasibility of distributing bupropion and     varenicline free of charge to treatment-seeking smokers in the province of Ontario, Canada     and (2) to evaluate the real-world effectiveness of bupropion and varenicline treatment in     Ontario compared to a no-drug comparison group. In an open label study, Ontario smokers who     smoke 10 or more cigarettes per day and intend to quit smoking in the next 30 days, will     enroll via the study website, visit their physician to receive a prescription for bupropion     or varenicline for 12 weeks or neither if they so choose, forming the no-drug comparison     group. All participants will receive weekly motivational emails for 12 weeks. Abstinence     measures will be taken at 4, 8 and 12 weeks and at 6 and 12 months. The proportion of     eligible participants who were able to confirm an appointment with a physician to receive the     prescription will be also measured.   "
241791|NCT01008085|"     Study hypothesis: the Stentys self-expandable Stent results into a better alignment of the     struts to the vessel wall than a balloon-expandable stent within a few days after the     procedure in acute myocardial infarction patients.   "
241792|NCT01008098|"     The objectives of the current study are        1. to evaluate the efficacy of escitalopram in treatment for post-traumatic stress          disorder,        2. to find the structural changes of brain using magnetic resonance imaging and its          association with the symptoms reduction, and        3. to look at the differences of brain imaging findings and symptoms changes according to          genetic differences of brain-derived neurotrophic factor (a biological molecule          facilitating neuronal growth in human).   "
241775|NCT01023672|"     This research study is to examine the effects of the study medication Armodafinil in patients     with dementia with Lewy bodies (DLB).      DLB is associated with memory and other thinking problems, excessive daytime sleepiness,     hallucinations, delusions, apathy, and reduced quality of life.      One type of medication that could potentially improve daytime sleepiness, memory and thinking     skills, hallucinations, delusions, apathy, and quality of life is known as a wake-promoting     medication. Armodafinil is a wake-promoting medication that has been developed for treatment     of patients with narcolepsy, sleep apnea, and other disorders which cause excessive daytime     sleepiness.      The drug used in this study is considered investigational, which means it has either not been     approved by the Food and Drug Administration (FDA) for routine clinical use or for the use     described in this study. However the FDA has allowed the use of this drug/device in this     research study.      In this study, patients with DLB will receive daily oral Armodafinil tablets, and their     response to treatment will be assessed over 12 weeks. This study does not involve any placebo     medication, so all patients will receive Armodafinil treatment.   "
241776|NCT01023685|"     This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections     of CAD106 in Alzheimer's Patients.   "
241777|NCT01023698|"     Is it possible to do a panretinal photocoagulation for proliferative diabetic retinopathy in     a single session using low fluence parameters?   "
241778|NCT01023711|"     The purpose of this study is to describe the immune response to a novel H1N1 influenza     vaccination in healthy adults, and to understand the factors that allow healthy adults to     respond to a single dose of vaccine even if they have never previously experience novel H1N1     disease or vaccination.   "
241779|NCT01023724|"     Approximately 50 patients undergoing cataract surgery will be randomized in an even     allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09%     BID. Patients will be instructed to begin dosing study medication in the operative eye the     day before surgery and continue dosing until day 14. KOWA flare measurements will be     performed at postoperative day one and postoperative day 14. The amount of anterior chamber     inflammation (flare) will be objectively measured.   "
241780|NCT01023737|"     This study is an open label non randomized study of hydroxychloroquine (HCQ) with histone     deacetylase (HDAC) inhibitor Vorinostat in patients with advanced solid tumors to determine     the maximum tolerated dose (MTD) and to evaluate the safety and antitumor activity of this     drug combination.   "
241781|NCT01023750|"     Fenofibrate is one of the best options for treating hypertriglyceridemia. In the majority of     patients, fenofibrate lowers triglycerides (TG) by 24-55% and improves HDL- and     LDL-cholesterol. However, the response to fenofibrate is highly variable and currently there     are no screening tests to identify poor responders. Genetic and environmental factors may     explain the high variability in response. Although exploratory in nature, this study is of     clinical and public health importance because prediction of drug response among those with     hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large     ($90 to $130/patient/month); targeting the responsive patients at the outset will help     improve treatment outcomes at a lower cost. If successful, the investigators will propose to     conduct a large, randomized trial on the effect of pre-prescription genotyping on fenofibrate     response.   "
241782|NCT01023763|"     The primary objective for the project is to evaluate whether nursing home residents who     require intravenous fluids and intravenous antibiotics, can be treated just as well or even     better in the nursing home as in the hospital. In Vestfold, Norway, a structured training     program in the intravenous treatment of dehydration and infections in nursing homes is     planned. The 3IV study will evaluate if this leads to an equal or better patient trajectory     and reduced hospital admittance.   "
241783|NCT01023776|"     The purpose of the study is to determine the amount of live virus that can be recovered from     the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to     describe the immune response to vaccination.   "
241784|NCT01023789|"     The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the     ABSORB Bioresorbable Vascular Scaffold (BVS) System      ABSORB BVS is currently in development at Abbott Vascular.   "
241785|NCT01023802|"     In patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone     therapy molecular breast imaging (MBI) is an accurate test for assessing response rate to     neoadjuvant therapy.   "
241786|NCT01023815|"     This study will compare the following immunosuppressive regimens in recipients of kidney     transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and     cyclosporine given twice a day with steroid withdrawal; C) everolimus, cyclosporine given     twice a day and continuous steroids. The purpose of this study is to evaluate regimens A and     B in comparison with the control group (group C) for efficacy, using as main endpoint the     treatment failure rate, a composite endpoint including death, graft loss, BPAR and lost to     follow-up between randomization and Month 12.   "
241787|NCT01023828|"     Summary:      Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the world.     This neoplasia has a poor survival prognosis due to the low effectiveness of existing     treatments. The low effectiveness is associated with the development of an intrinsic and     acquired resistance of tumors, which clinically shows through early progression and     transitory responses. Tobacco smoking is the major risk factor for NSCLC; however, wood smoke     has been described as a strong carcinogen and a relevant risk factor for the development of     NSCLC. Current data indicates that lung tumors associated with tobacco smoking and wood smoke     show different clinical characteristics, which suggests that they might also have different     genetic alterations, which are a consequence of tumor etiology. The description of the     frequency and the type of mutations associated with different etiologies of NSCLC could     represent the starting point for benefiting each patient according to their specific     characteristics. One of the most researched signaling pathways related to cancer cell     proliferation is the one activated by the K-RAS oncogene. Active K-RAS mutations have been     detected in different types of neoplasia and more than 90% of these mutations occur at codon     12 of the oncogene. These mutations seem to be an independent risk factor for the prognosis     of malignant tumors and they are associated with the lack of response to erlotinib, which is     a tyrosine-kinase inhibitor. The investigators' research team has recently reported that wood     smoke is an independent factor for survival and response to the erlotinib treatment, which     suggests that this carcinogen could have a different frequency and pattern of mutations in     the K-RAS oncogene, compared to what has been reported in smoking patients. Determining the     tumor mutations within the K-RAS oncogene can help improve the response prognosis of patients     with advanced NSCLC who have a background of exposure to different factors associated with     the appearance of this neoplasia, such as wood smoke exposure or tobacco smoking. Therefore,     the objective of this research is to determine the frequency and the type of mutations at     codon 12 of the K-RAS oncogene in patients with NSCLC who have a background of exposure to     tobacco smoking or wood smoke.   "
241788|NCT01023841|"     This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily     application to the upper eyelid margins compared with vehicle in treating eyelash loss or     hypotrichosis (inadequate or not enough eyelashes) in children.   "
241793|NCT01008111|"     The purpose of this research study is to test the safety of an oxygen producing gel (produced     by combining baking soda and hydrogen peroxide) and see what effects (good and bad) it has on     skin incisions in children.      Baking soda and hydrogen peroxide have been approved by the US Food and Drug Administration     (FDA), but have not been approved for use in this manner.      It is hypothesized that a combination of sodium bicarbonate and hydrogen peroxide may enhance     wound healing of incisional wounds for bilateral hernia repair.   "
241794|NCT01008124|"     This study is being done because the investigators would like to know how effective the     Liberatory maneuver is in treating benign paroxysmal positional vertigo (BPPV).   "
241796|NCT01008150|"     FB-7 is a Phase II, multi-center randomized study of neratinib in combination with weekly     paclitaxel with or without trastuzumab followed by doxorubicin and cyclophosphamide (AC) as     neoadjuvant therapy for women with HER2-positive locally advanced breast cancer. Patients in     the control arm will receive neoadjuvant trastuzumab in combination with weekly paclitaxel     followed by AC. The primary aim of the study is to determine the pathologic complete response     (pCR) rate in breast and axillary nodes following the neoadjuvant therapy regimens. The     secondary aims include determination of the pCR rate in breast only, clinical complete     response (cCR) rate, two-year recurrence-free interval, two-year overall survival, toxicity     of the neoadjuvant regimens, and exploration of molecular and genetic correlates of response.   "
241797|NCT01008163|"     The purpose of this trial is to determine the dosage selected and to evaluate the efficacy     and safety of YY-351.   "
241798|NCT01008176|"     Cutting back on sleep duration has developed into a common, highly prevalent habit in the     adult population, and may lead to a major health problem. Large epidemiological studies have     demonstrated that short sleep duration is associated with increased risk of cardiovascular     disease (CVD). The investigators' preliminary data on the effects of experimental sleep     reduction have shown elevation of blood pressure (BP) and inflammatory markers, such as     interleukin-6 (IL-6) and C reactive protein (CRP), suggesting that both may play an important     role in linking sleep loss and CVD risk. With this background, the investigators hypothesize     that restoring sleep homeostasis, i. e. getting adequate amounts of sleep, is an effective     behavioral intervention in the treatment of elevated BP.      The investigators will test this hypothesis in subjects with BP above normal and with short     habitual sleep duration, as verified by sleep logs and actigraphic recordings. Subjects will     either undergo 6 weeks of mild sleep extension, in which 60 min of bedtime will be added to     the habitual sleep duration, or subjects will maintain their habitual sleep duration for the     following 6 weeks.      Regarding their first specific aim, the investigators expect that sleep extension across 6     weeks will lower BP, inflammatory (IL-6, CRP, cell adhesion molecules) and autonomic markers     (catecholamines). In particular, the investigators expect that in subjects with mild BP     elevation, i. e. with pre-hypertension, sleep extension leads to normalization of BP.      This study presents a very first approach in using sleep behavior components for the     treatment of elevated BP. Therefore, the investigators' second specific aim will characterize     the strength of associations between changes in sleep duration, BP, and inflammation, and     they will explore factors that are predictive for these changes. In particular, adiposity, as     measured by percent body fat, has frequently been shown to be related to short sleep duration     and inflammatory processes, but the role of adiposity in modulating the physiological     consequences of changes in sleep duration has never been addressed.      If the investigators' hypothesis is correct, sleep extension may be considered as an     additional component in current lifestyle intervention programs in combating and preventing     hypertension.   "
241799|NCT01008189|"     Six-years following participation in the Family Bereavement Program (FBP) participants in the     program as compared to a self-study control group will have lower levels of mental health     problems, lower one-year prevalence of mental disorder that meets diagnostic criteria, lower     use of substances, higher levels of competence at achieving developmentally appropriate tasks     in academic achievement and social competence, and better self-esteem. The effects of the FBP     will be moderated by baseline levels of mental health problems and gender. Bereaved     caregivers who participated in the program will also show lower levels of mental health     problems as compared with controls.      Program effects will be mediated by theoretical mediators targeted by the program.   "
241800|NCT01008215|"     Can a simple and cost-free tool help family physicians to improve dosing of the blood thinner     warfarin?      Warfarin is a blood thinner with a variable effect and requires regular blood monitoring and     dose adjustments. Some family practices do not have the facilities or funding to use     commercial tools than can assist with stabilizing the effect of warfarin. The investigators     will test whether a simple and cost-free dosing tool can help these practices to improve     warfarin management.      If this simple tool improves warfarin management, it will be freely available for practices     in Canada and around the world. This will help physicians who have no access to more costly     and/or complicated tools improve their warfarin dosing practice in a systematic fashion, and     thereby maximize the health benefit of warfarin.   "
241801|NCT01008228|"     Management of primary spontaneous pneumothorax (PSP) remains unclear. Primary therapeutic     goals for PSP include removal of air from the pleural space an prevention of recurrences. The     absence of generally accepted and methodologically sound recommendations may account for the     extensive variation in practice for air evacuation techniques. Air evacuation may be achieved     by simple aspiration (exsufflation) or conventional chest tube drainage. Chest tube     thoracotomy remains the most popular technique.Aspiration is a more simple technique, that     allows possibility of ambulatory management. The purpose of the present study is to compare     simple aspiration performed with a specific thoracentesis device, versus conventional chest     tube drainage. Comparison will be performed on immediate efficacity of resolution of the     pneumothorax.The hypothesis is that simple aspiration performed with a specific device is not     inferior to chest tube drainage for management of a first episode of large size primary     spontaneous pneumothorax. A second goal is to measure the efficacy at one week, and the     recidive at one year. The trial is randomized, controlled and will include 200 patients for     each group. The patients will be enrolled in 29 hospitals in France. Emergency department,     thoracic surgery and pulmonary departments of each hospital were primarily contacted for     agreement to participate to the study.   "
241823|NCT01008514|"     RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near     a tumor to kill tumor cells. It may also cause less damage to normal tissue.      PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in     treating women with early-stage breast cancer.   "
241824|NCT01008527|"     The purpose of this study is to determine what side effects CP 870,893 may cause when given     with an immune stimulant called Oncovir poly IC:LC along with a melanoma vaccine. The CP     870,893, the Oncovir poly IC:LC and the melanoma vaccine are investigational drugs that have     not been combined in patients before, and that have not been approved for sale by the Food     and Drug Administration. The Oncovir poly IC:LC is intended to stimulate the body's immune     system.   "
241802|NCT01008241|"     The goal of this cross-sectional study is to gain an understanding of the knowledge and     attitudes regarding end of life issues and hospice care among a sample of residents of South     Florida recruited through time and space sampling. This study is being conducted by OMS3 COM     research fellow Heather Ruff as part of the research fellowship requirements.      Participants will complete a paper and pencil questionnaire that measures 4 domains of     interest (advanced care planning; end of life care; hospice care and death and dying) as well     as demographic factors (age, marital status, education etc.). It is estimated that the survey     will take 15 minutes to complete. Data will be collected anonymously, with no personal     identifying information. The instructions on the questionnaire state that by completing the     questionnaire, the participant is providing consent to participate in the study. We will use     time and space sampling methods to recruit up to 250 participants at community venues (i.e.,     beaches, street corners, parks, pedestrian malls, and other public venues were people     congregate) in South Florida. At each venue, we will define a specific area; persons who     enter the defined area will be approached, screened for eligibility (18 years of age or older     and a resident of South Florida), and if eligible, invited to participate by trained research     staff. Sampling intervals will be determined by traffic flow at each venue. If a person     agrees to participate they will be given a paper and pencil copy of the survey to complete on     the spot. Participants will be given $1.00 as a token of appreciation. Data entry and data     analyses will be done using SPSS.   "
241803|NCT01008254|"     Musical reminder will raise compliance with mobility in the long-term care setting and reduce     facility-acquired pressure ulcers.   "
241805|NCT01008280|"     Hepatitis C (HCV) is the most common blood born virus in the United States, affecting 1.8% of     the general population and more than 5% of Veterans using VA facilities. As Veterans with HCV     have high rates of co-morbid alcohol use disorders that accelerate greatly the liver damage     caused by HCV, a safe and effective treatment for alcohol use disorders is needed. Baclofen     is a novel treatment for alcohol use disorders that has minimal effect on the liver and may     represent a safe and efficacious treatment option for Veterans with HCV and co-morbid alcohol     use disorders.   "
241806|NCT01008293|"     This study is a randomized, open, parallel group, active comparator, single center trial.     Objectives of the study are hereby given below:        -  To study the health related quality of life (HRQOL) in patients with chronic liver          disease.        -  To assess the prevalence of minimal hepatic encephalopathy (MHE) in patients with          chronic liver disease and assessment of HRQOL in patients with MHE.        -  To compare the effect of probiotics and lactulose in the treatment of MHE        -  To assess the effect of probiotics and lactulose on the HRQOL in patients with MHE.   "
241807|NCT01008306|"     Renal transplantation of children started in Norway in 1970.Since the beginning, >80% of     renal transplants are provided from Living Donors(mainly parents), short pre-transplant     dialysis time( median 4 months) and 50% of transplantations are performed before dialysis is     needed.This gives good premises for graft survival and avoidance of detrimental effects of     dialysis. However, renal transplanted children are subjected to an increased cardiovascular     morbidity and mortality in adulthood due to consequences of chronic renal failure and     immunosuppressive treatment.Cardiovascular death comprises 30-40% of death causes. In this     cross-sectional study we evaluate cardiovascular risk factors in childhood- and also in young     adults renal transplanted in childhood.      Focus is cardiorespiratory fitness using treadmill testing,24h BP measurements,     anthropometrics including waist circumference,echocardiography,intima media thickness of     carotids, glucose intolerance test.Participants are also requested to fill out physical     activity recalls and Quality of life questionnaires.   "
241808|NCT01008319|"     The purpose of this study is to compare the length of time to achieve ovulation and pregnancy     with a traditional protocol administration of clomiphene citrate versus a stair step     administration.      Our hypothesis is by using a stair-step approach in which a period is not induced between     administrations of escalating doses of clomiphene citrate, the time to ovulation and     pregnancy may be reduced.   "
241809|NCT01008332|"     The prevalence of allergic sensitisation to House Dust Mite (HDM) varies from region to     region and depends on the regional prevalence of HDM. In the third National Health and     Nutrition Examination Surveys, 54.3% of the US population had positive test responses to one     or more allergens, with the prevalence for HDM being 27.5%. Like many other allergens,     exposure to HDMA in sensitised patients is associated with poorer lung function, greater     medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms.      ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine,     currently being developed for the treatment of Houst Dust Mite allergy.      The purpose of the present study is to evaluate the safety and tolerability of multiple     ascending doses of ToleroMune HDM in subjects in subjects with a documented history of     allergic rhinoconjunctivitis on exposure to house dust mite. The efficacy of ToleroMune HDM     will also be explored in these subjects using the Late Phase Skin Response, Early Phase Skin     Response and Conjunctival Provocation Test.   "
241810|NCT01008345|"     Randomized study. Patients with coronary artery disease equivalent will be randomized to     receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day.     Oxidized LDL cholesterol will be measured at baseline and after 8 weeks of treatment.     Hypothesis is that ezetimibe will lower oxidized LDL   "
241811|NCT01008358|"     CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T     lymphocytes and by enhancing their activation may produce a stimulation of the immune     response against tumoral or viral antigens. In this clinical trial, the ability of     tremelimumab to produce tumor responses among hepatitis C virus-infected patients with     hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the     effect on the replication of the virus will be analysed.   "
241812|NCT01008371|"     The purpose of this study is to determine abnormal neuro-hormonal mechanisms that may impair     the ability to feel full and which therefore, may lead to obesity.   "
241838|NCT01009554|"     This study is 8 weeks long. People participating in this study will be asked to brush their     teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse     two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked     at by a dentist. The dentist will look at the mouth to make sure the mouthwash does not     irritate the mouth. The dentist will also look at the color of the teeth and amount of stain     on the front teeth.   "
241813|NCT01008384|"     Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to     others, and available as a dietary supplement. It is also produced in the body when     ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Vitamin D is     essential for promoting calcium absorption and maintaining adequate serum calcium and     phosphate concentrations to enable normal mineralization of bone and bone growth. Without     sufficient vitamin D, bones can become thin, brittle, or misshapen. Vitamin D sufficiency     prevents rickets in children and osteomalacia in adults. Together with calcium, vitamin D     also helps protect older adults from osteoporosis. Many people have low levels of Vitamin D.     Replacing Vitamin D is thought to help lower the risk of heart disease. Vitamin D may be     helpful, but it could also be harmful. The investigators are studying the effect of Vitamin D     on the level of a harmful kind of cholesterol. Participants will have their cholesterol     levels measured and then receive either Vitamin D or a placebo. After 2 months of treatment,     the investigators will measure their cholesterol levels again.   "
241814|NCT01008397|"     Objectives:      A) To gather pharmacodynamic measurements and assess blood levels of the active ingredients     in AHIST over the dosage interval period of 12 hours.      Hypothesis: Hysteresis curves plotting each active ingredient's blood levels over a 12-hour     dosage interval will substantiate S5 Symptom Diary scores (IE: evidentiary therapeutic window     data);      B) To report subjective scores by subjects rating the efficacy of a single dose AHIST in     relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over a     12-hour dosage interval.      Hypothesis: Greater than 66% of subjects will document clinically significant relief over a     12-hour period from one dose of AHIST;      C) Report any side effects or adverse drug reactions and rate the severity of any incidence.      Hypothesis: Not more than one patient will have an adverse event significant enough to     warrant withdrawal; side effects will be mild with the most frequently reported side effect     occurring in less than 10% of patients—drowsiness.   "
241815|NCT01008410|"     The purpose of this study is to establish the efficacy profile of rectally administered     budesonide foam administered as 2mg/25mL BID for 2 weeks followed by 2mg/25mL QD for 4 weeks,     as compared to an equivalent volume of rectally administered placebo foam over the same     dosing schedule, in subjects who present with a diagnosis of active, mild to moderate,     ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible     subjects will be allowed to maintain previously established oral 5-ASA treatment at doses up     to 4.8g/day.   "
241816|NCT01008423|"     The purpose of this study is to establish the efficacy profile of rectally administered     budesonide foam administered as 2mg/25mL BID for 2 weeks followed by 2mg/25mL QD for 4 weeks,     as compared to an equivalent volume of rectally administered placebo foam over the same     dosing schedule, in subjects who present with a diagnosis of active, mild to moderate,     ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible     subjects will be allowed to maintain previously established oral 5-ASA treatment at doses up     to 4.8g/day.   "
241817|NCT01008436|"     The study enrolles all consecutive patients undergoing cardiac surgery at the European     Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis     or added topical application of Omni-stat Celox.      The two populations are followed up prospectively as regarding blood loss and need for blood     transfusions, as well as adverse events at 30 days after surgery.   "
241818|NCT01008449|"     The objective of this randomized controlled trial is to compare wound morbidity (including     disruption and infection) in surgical staples versus absorbable subcuticular suture for wound     closure in cesarean deliveries.   "
241819|NCT01008462|"     This phase II trial studies autologous peripheral blood stem cell transplant followed by     donor bone marrow transplant in treating patients with high-risk Hodgkin lymphoma,     non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia. Autologous stem cell     transplantation uses the patient's stem cells and does not cause graft versus host disease     (GVHD) and has a very low risk of death, while minimizing the number of cancer cells.     Peripheral blood stem cell (PBSC) transplant uses stem cells from the patient or a donor and     may be able to replace immune cells that were destroyed by chemotherapy. These donated stem     cells may help destroy cancer cells. Bone marrow transplant known as a nonmyeloablative     transplant uses stem cells from a haploidentical family donor. Autologous peripheral blood     stem cell transplant followed by donor bone marrow transplant may work better in treating     patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic     lymphocytic leukemia.   "
241820|NCT01008475|"     The purpose of this study is to assess the safety and clinical activity of the experimental     drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination     with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.   "
241821|NCT01008488|"     The purpose of this study is to evaluate if antibiotic therapy is necessary for treatment of     uncomplicated colonic diverticulitis.      The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover     the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to     complications.      The patients will be randomized to conservative treatment with and without antibiotic     therapy.   "
241822|NCT01008501|"     The researchers' laboratory is studying a rare class of highly recurrent hydatidiform moles.     These are usually complete hydatidiform moles (CHM), but sometimes they are partial     hydatidiform moles PHM). With sporadic moles, the difference between CHMs and PHMs is that     with CHMS, there is not typically an embryo or fetus at the time of diagnosis but with a PHM     there may be a fetus. Also, CHMs have 46 chromosomes in each cell. While this is the number     of chromosomes that should be found, the problem is that all the chromosomes come from the     father. Normally, half the chromosomes should come from the mother and half should come from     the father. Unlike CHMs, PHMs have 69 chromosomes. This means that PHMs have three copies of     each chromosome when they should only have two. The extra copy comes from the father.      The researchers' study focuses on moles that are genetically different from these sporadic     moles in that they have 23 chromosomes from the mother and 23 chromosomes from the father -     just like a normally developing pregnancy. These are called biparental moles because the     mutation that causes the mole comes from both parents. This mutation occurs in a gene called     NLRP7. The researchers' team is working to understand how mutations in NLRP7 leads to CHMs     and how these mutations may lead to other types of pregnancy loss. The researchers are also     trying to discover other genetic and epigenetic factors that may lead to moles.   "
241825|NCT01008540|"     The investigators aim is to determine the incidence of cytomegalovirus resistance to     antivirals in a cohort study. The patients are included at their first CMV active infection     and are followed during two years thereafter. When criteria for suspected resistance are     meet, blood and urine samples are collected for virus isolation and further resistance     phenotype, and for resistance genotype determination. Results are compared with baseline     samples. Clinical information such as treatment, immunosuppressive regimen and clinical     evolution will be collected. Through this study, the investigators aim to organize a national     network for the detection and identification of CMV resistant strains that will be useful     when new therapeutics will be available.   "
241826|NCT01008553|"     The purpose of this study is to evaluate the efficacy and safety of fentanyl in opioid-naive     participants with post-herpetic neuralgia, complex regional pain syndrome or post-operative     pain syndrome who cannot obtain a sufficient analgesic effect by the treatment of non-opioid     analgesics (drug used to control pain).   "
241827|NCT01008566|"     This phase I trial is studying the side effects and best dose of cixutumumab when given     together with sorafenib tosylate in treating patients with advanced liver cancer. Monoclonal     antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with     sorafenib tosylate may kill more tumor cells.   "
241828|NCT01008579|"     Patient reported outcome measures (PROMs) are assessments of health status or health-related     quality of life. The EuroQol-5D (EQ5D) is an example of a generic instrument to assess     health-related quality of life. The investigators will use the EQ5D in the Falls Prevention     Clinic as part of routine clinical assessment at baseline, 6 months and 12 months to track     patient care in a cohort of 300 older adults who are at high-risk of falls.   "
241829|NCT01008592|"     Levocetirizine (Xyzal®), the active levorotatory enantiomer of cetirizine (Zyrtec®), is a     FDA-approved drug used in the treatment of symptoms associated with seasonal and perennial     allergic rhinitis and chronic idiopathic urticaria. The parent compound, cetirizine was shown     to be effective against experimental dermatographism, however no study has been conducted so     far on the effect of levocetirizine on the inhibition of dermatographism. It is known that     cetirizine is a mast-cell stabilizer and decreases histamine levels and the number of     tryptase positive mast cells. Cetirizine inhibits the production of interleukin 8 (IL8) and     leukotriene B4 (LTB4) by immune cells - two potent chemoattractants - and induces the release     from monocytes of prostaglandin E2 (PGE2), a suppressor of antigen presentation and MHC class     II expression. However, the effects of the most active enantiomer levocetirizine on these     inflammatory mediators have not been evaluated so far. Therefore, we aim to conduct a study     in humans with dermatographism and chronic idiopathic urticaria to evaluate the effect of     levocetirizine on the above-mentioned mediators. The study will involve the use of skin     microdialysis, a minimally invasive technique to measure inflammatory mediators in the     extracellular space in dermis.   "
241830|NCT01008605|"     The purpose of this study is to demonstrate the usability of the system.   "
241831|NCT01008618|"     The purpose of this study is to evaluate efficacy and safety of fentanyl in opioid-naive     participants with osteoarthritis (disorder, which is seen mostly in older persons, in which     the joints become painful and stuff) or low back pain who cannot obtain a sufficient     analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).   "
241832|NCT01008631|"     The pharmacokinetics of sodium thiosulfate in humans with different degrees of renal failure     and in healthy volunteers will be after two single shot applications.   "
241833|NCT01009476|"     The main objective of this non-interventional study was to document the long-term application     of galantamine and nootropics (memory enhancing drugs) over a period of 1 year under     conditions of daily routine. There were no predefined specifications of diagnostic and     therapeutic measures. The decision for treatment with either galantamine or a nootropic had     to be made by the treating physician prior to the start of documentation. The following     measures were to be documented: safety, tolerability, dementia-associated symptoms (unstable     walking, vertigo, awakening at night, shouting/screaming at night, perambulating at night,     aggressiveness, agitation, apathy/social retreat, delusions, hallucinations, behavior that     poses a risk to self or others, and daytime tiredness), frequency of admissions to nursing     homes or nursing services, global functional level, caregiver's burden, and time spent on     caregiving. Furthermore, this study aimed to gather knowledge on the differentiated use of     the two treatment strategies considering the specific diagnosis of dementia (e.g. Alzheimer's     disease only or mixed dementia, i.e. Alzheimer's disease and cerebrovascular disease) and     risk profiles.   "
241834|NCT01009502|"     Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.      This was originally designed as a phase I/II trial studying the side effects of sodium     stibogluconate and how well it works in treating patients with myelodysplastic syndromes.     Unfortunately, due to funding issues, the phase II portion was never conducted.   "
241835|NCT01009515|"     The number of melanoma cases has been steadily increasing over the past few decades. For many     patients with metastatic melanoma, there are no effective therapies. The goal of this study     is to determine whether a combination drug treatment of carboplatin, paclitaxel and     temozolomide is effective in the treatment of metastatic or recurrent melanoma.   "
241836|NCT01009528|"     The aim of this study is to determine whether electronic feedback to general practitioners on     quality of Type 2-Diabetes care increases the quality of care measured on process and outcome     measures contained in the national guidelines. Effect evaluation will be performed using a     mixed method design.   "
241837|NCT01009541|"     The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of     three pregabalin controlled release tablets as compared to multiple doses of the pregabalin     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three     pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate     release capsule and 3) evaluate the safety and tolerability of multiple doses of three     pregabalin controlled release tablets as compared to multiple doses of the pregabalin     immediate release capsule.   "
241842|NCT01009606|"     The bereavement generated by the loss of a family member can induce pathological situations:     depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid     factors can be influenced by the death circumstances and in particular by the possibility     given to the family to attend the medical management of the patient. This clinical trial aims     to evaluate the psychological consequences of bereavement on the relatives according to the     possibility of witnessing the cardiopulmonary resuscitation of a family member. This     possibility lies within the scope of a strategy of global management of the relatives.   "
241843|NCT01009619|"     Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans     Syndrome after lung transplantation.   "
241844|NCT01009632|"     The purpose of this study is to explore quantitatively the hypothesis that resonant voice,     may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human     laryngeal secretions and secondarily, clinical tests.   "
241845|NCT01009645|"     The purpose of this study is to evaluate whether message design of educational materials     increases vaccination rates among participants.   "
241846|NCT01009658|"     The purpose of this study is to clarify the physiological function of sodium glutamate by     measuring its effect on upper GI motility ( gastric emptying).   "
241847|NCT01009671|"     The primary objective of this study, comparing ART 44 to ART 50, will be the evaluation of     digestive tolerability (and in particular of diarrhoea).   "
241848|NCT01009684|"     The primary objective of the study is to assess the risks of short and long-term use of     estradiol valerate/dienogest (EV/DNG) and of established oral contraceptives (OCs) in a study     population that is representative for the actual users of the individual preparations. This     includes an estimate of the absolute risk of rare serious adverse outcomes.   "
241849|NCT01009697|"     The objective of this study was to examine the dose linearity of Roxane Laboratories' 15 mg,     30 mg, and 60 mg codeine sulfate tablets under fasted conditions   "
241850|NCT01009710|"     A specific group of neurons in the brain produces hypocretin, a peptide which has been     established as an important regulator of sleep and wakefulness. Activation of these neurons     (increased hypocretin) stabilizes wakefulness; impairing or blocking these neurons (decreased     hypocretin) promotes sleep. Evidence suggests that these neurons may be involved in the     hypnotic properties of several anesthetics, and play a role in the induction and emergence     from anesthesia. In humans there is a considerable inter-individual variability in hypocretin     levels. This study aims to investigate how hypocretin levels affect the anesthetic care and     recovery of patients undergoing elective hip surgery.   "
241851|NCT01009723|"     This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women.     The biological specimens will be used to determine the predictive power of biochemical     markers routinely used in Down syndrome screening in the assessment of patient's risk of     preterm delivery.   "
241852|NCT01009736|"     RATIONALE: Tomato-soy juice may slow the growth of tumor cells. Studying samples of blood and     tissue from patients with prostate cancer in the laboratory may help doctors identify     biomarkers related to cancer. It may also help doctors understand the effect of tomato-soy     juice on biomarkers.      PURPOSE: This phase I/II trial is studying the side effects of tomato-soy juice and its     effect on biomarkers in patients with prostate cancer undergoing prostatectomy.   "
241853|NCT01009749|"     This is a two-phase study, consisting of the following plan:      Phase I - This is a pre-test of the feasibility and acceptability of the beta version of a     computer-delivered intervention, Motivational Enhancement System for Adherence (MESA), as     well as the control intervention Motivational Enhancement System for Health (MESH) at three     selected AMTUs. Following analysis of the responses in Phase I and further modification of     the intervention, Phase II will be initiated.      Phase II - This is a pilot, randomized, controlled trial (RCT) testing a two-session     computer-delivered intervention, MESA, designed to increase motivation for adherence to     Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin     medications, as well as an attention control, MESH, matched for dose and delivery format.     Phase II is open to all 15 AMTUs.   "
241854|NCT01009762|"     Treatment: Immunization with a peptide-mix of 17 Clusters of Differentiation number 8 (CD8) T     cell minimal epitopes and 3 Clusters of Differentiation number 4 (CD4) T cell epitopes and a     new adjuvant (CAF01). The vaccine should induce cellular immunity against human     immuno-deficiency virus type-1 (HIV-1).      Target group: Untreated healthy individuals with chronic HIV-1 infection who are not in     antiretroviral treatment.      Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine.      The secondary purpose is to evaluate the clinical effect of the vaccination treatment as     measured by induction of new T cell immunity, lowering of HIV-1 ribonucleic acid (RNA) viral     load in plasma, and improvement in the patient CD4 lymphocyte blood counts.      Design: The experiment is designed as a single-blinded, placebo-controlled phase 1 clinical     trial in HIV-1 infected individuals in Denmark.      Numbers of individuals: 20 fully evaluable HIV-1-infected patients should enter the study (15     vaccine treated and 5 placebo(saline) treated controls).      The hypothesis is that a redirection of cytotoxic T lymphocyte (CTL) immunity to selected     relatively immune silent (subdominant) but conserved CTL targets on multiple sites in HIV-1     could provide a better immune control of the virus replication. This could result in lowering     of viral load thereby prolonging the time to antiretroviral therapy.   "
241855|NCT01009775|"     The purpose of the study is to evaluate survival, response rate, safety and tolerability of     YM155 given in combination with docetaxel in subjects with Stage III (unresectable) and Stage     IV melanoma.   "
241868|NCT01009944|"     The purpose of this study is to develop an approach to provide personalized medicine to     individuals who have hypertension (high blood pressure). The investigators plan to use     people's genetic characteristics (traits) to determine what medication they should use to     lower their blood pressure most effectively. The investigators will give individuals one of     two medications to treat hypertension (lisinopril or atenolol). The investigators believe     that depending on the individuals genetic background one medication will work better in     lowering their blood pressure.   "
241869|NCT01009957|"     The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down     the progression of CKD in ADPKD patients.   "
241856|NCT01009788|"     The purpose of this research study is to find out if the combination of ABT-888 and     temozolomide is safe and effective in treating patients with metastatic breast cancer.     ABT-888 works by obstructing a DNA enzyme called poly (ADP-ribose) polymerase (PARP) which     helps repair cancer cells damaged by chemotherapy. By blocking the PARP enzyme, the cancer     cells are unable to repair themselves and as a result die. The other drug in this study is     temozolomide. Temozolomide is designed to damage DNA in order to prevent cancer cells from     reproducing. Because PARP inhibitors, such as ABT-888, prevent cancer cells from repairing     their own DNA, they enhance the potential of chemotherapy therapy like temozolomide to induce     cell death. The combination of ABT-888 and temozolomide has been used in a clinical trial for     treatment of other cancers and information for this research study suggests that the     combination may help to inhibit growth in breast cancer.      ONLY THE EXPANSION COHORT BELOW IS RECRUITING:      BRCA CARRIER EXPANSION COHORT: The purpose of the expansion cohort is to further evaluate the     activity and safety of this combination in BRCA mutation carriers with metastatic breast     cancer.   "
241857|NCT01009801|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking     the blood flow to the tumor. Everolimus may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet     known whether transarterial chemoembolization with doxorubicin is more effective when given     alone or when given together with everolimus in treating patients with liver cancer.      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of     everolimus when given together with transarterial chemoembolization with doxorubicin and to     see how well it works compared with giving transarterial chemoembolization with doxorubicin     alone in treating patients with liver cancer.   "
241858|NCT01009814|"     Research Hypothesis: Administration of BMS-663068, a prodrug for HIV attachment inhibitor     BMS-626529, will result in a mean decrease of at least 1 log10 in HIV RNA at Day 9 following     8 days of therapy in at least one dosing regimen that is safe and well tolerated in Clade B     HIV-1 infected subjects.   "
241859|NCT01009827|"     This study will collect information on health status and risk behaviors, as well as basic     demographic and biomedical information for a group of HIV positive adolescents receiving care     at the ATN sites.   "
241860|NCT01009840|"     Study for the outcome and safety of individualized busulfan dosing with bortezomib for     patients preparing for a second stem cell transplant to treat multiple myeloma.   "
241861|NCT01009853|"     Study to characterize the steady-state pharmacokinetics of codeine and its metabolites     morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral     administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15     mg Q4H x 5 days.   "
241862|NCT01009866|"     Purpose of the study:      Primary Objective: Determine the maximum tolerated dose (MTD) and dose limiting toxicity     (DLT) of MR1-1KDEL when delivered intracerebrally by convection-enhanced delivery (CED) in     patients with supratentorial malignant brain tumors.      Secondary Objective: Document any radiographic responses associated with intracerebral CED of     MR1-1KDEL.      Hypothesis: The investigators believe that MR1-1KDEL will be an effective anti-tumor agent     for patients with supratentorial malignant brain tumors when delivered by CED.      Design & procedures: This protocol is designed primarily to determine the MTD and DLT of a     novel, tumor-specific immunotoxin, MR1-1KDEL. MR1-1KDEL will be delivered intracerebrally by     CED using 2 intracerebral catheters with at least one catheter placed within the enhancing     portion of the tumor. 124I-labeled albumin will be co-infused with gadolinium and PET and MRI     images will be obtained at the conclusion of the infusion to monitor volume of drug     distribution and leakage into the CSF space.      Based on preclinical toxicity studies, the starting total drug dose will be 0.5μg (500ng)     which represents 1/20th of the MTD in rats. The infusion flow rate will be fixed at 0.5 mL/h     from each of two to four catheters. A total of 144 mLs of drug solution will be delivered     over 72 hours. MR1-1KDEL dose escalation will be accomplished by increasing drug     concentration allowing flow rate and infusion volume to remain unchanged. Drug dose will be     doubled in successive cohorts so long as DLTs are not observed as follows: 25 ng/mL (2.4     μg)(starting dose); 50ng/mL (4.8μg); 100 ng/mL (9.6μg); 200ng/mL (19.2μg); 400 ng/mL     (38.4μg); 800 ng/mL (76.8μg); and 1600 ng/mL (153.6μg). At least 3 patients will be enrolled     in each cohort. All patients in a given cohort will be observed for at least two weeks     following infusion of the study drug before patients in the next cohort are treated. If no     patients in a given cohort experience a DLT, the dose will be escalated in the next cohort.     If 1 out of 3 patients in a given cohort experience DLT, 3 additional patients will be     entered in that cohort. If 2 patients develop a DLT in any cohort of 3 or 6 patients, the     previous dose will be declared the MTD. Patients will be followed at 1, 3, 6, 9, 12 month     intervals for toxicity and adverse events, radiographic response, and survival. Patients will     be off study when progressive disease is documented.      Risk/benefit assessment: This is an experimental study and unforeseeable or unexpected risks     may be involved.   "
241863|NCT01009879|"     The purpose of the study is to determine the effects of TNF (tumor necrosis factor; a     mediator of inflammation) on B cells in patients with rheumatoid arthritis. TNF and B cells     are important in rheumatoid arthritis because they both appear to be involved in causing     rheumatoid arthritis.   "
241864|NCT01009892|"     The study was designed to assess the effect of food on the absorption of codeine from Roxane     Laboratories' 60 mg Codeine Sulfate tablet   "
241865|NCT01009905|"     This study is conducted in the United States of America (USA). The aim of this observational     study is to collect data concerning the treatment outcomes and safety for children and adults     who are prescribed Norditropin®. Specific objectives include: 1) developing models defining     the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and     treatment outcomes, accounting for independent factors such as age, gender and puberty and 2)     determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and     other factors before treatment to clinical outcomes.   "
241866|NCT01009918|"     RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is     not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing     side effects caused by trastuzumab.      PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work     compared with a placebo in reducing side effects in patients with HER2-positive breast cancer     receiving trastuzumab.   "
241867|NCT01009931|"     This phase II trial is studying the side effects and how well giving tetradecanoylphorbol     acetate together with dexamethasone and choline magnesium trisalicylate works in treating     patients with relapsed or refractory acute myeloid leukemia.   "
241870|NCT01009970|"     This is a multicenter study phase II, open-label for cardiopathic patients affected by     Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to     study the feasibility of R-COMP in this cohort of patients.   "
241964|NCT01016535|"     This study aimed to identify the perceptions of family caregivers and professionals of the     Family Health Strategy (FHS) for health care for children from 0 to 2 years, and actions on     this issue developed by the FHS.   "
241871|NCT01009983|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Other find tumor cells and     help kill them or carry tumor-killing substances to them. Giving panitumumab together with     paclitaxel and carboplatin may be a better way to block tumor growth.      PURPOSE: This phase II trial is studying the side effects and how well paclitaxel and     carboplatin together with panitumumab works in treating patients with metastatic triple     negative breast cancer.   "
241872|NCT01009996|"     KISSING DEBBIE's aim at assessing angiographic and clinical outcomes of provisional treatment     of coronary bifurca6on lesions according to TAP sten6ng with BMS and final kissing DEB   "
241873|NCT01010009|"     Research shows that resveratrol is able to induce vasodilation (and therefore blood flow) by     interacting with nitric oxide (NO). Research also shows that acute administration of     metabolic substrates, like oxygen and glucose, can enhance aspects of cognitive performance     in young, healthy humans. The aim of this investigation was to determine if the consumption     of resveratrol could modulate cerebral blood flow and if this in turn could influence     cognitive performance by increasing access to blood borne metabolic fuel. Results showed that     compared to placebo, after consuming 500mg pure trans-resveratrol, levels of total     haemoglobin were significantly higher in the frontal cortex of young, healthy participants     during cognitive task completion. Cognitive performance was not effected.   "
241874|NCT01010022|"     The study shall evaluate the efficacy and safety of two different hydroxyethyl starch     solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative     therapy of hypovolemia and maintenance of circulating blood volume in patients undergoing     orthopedic surgery. The primary efficacy endpoint will be the required volume of colloid     solution infused from start until end of surgery. It is the aim of the clinical trial to     demonstrate that comparable volumes of colloid solution are used between treatment groups.   "
241875|NCT01010035|"     The diabetic dyslipidemia is one of the most important risk factor in the development of     coronary artery disease. The low density lipoprotein (LDL)-like nanoemulsions is being used     to study the clearance of cholesteryl ester and free cholesterol from intravascular in     patients with advanced coronary artery disease and it was shown a higher removal of free     cholesterol and higher deposit in vases of this patients. The aim of this study is to analyze     the plasma kinetics of both forms of cholesterol(free ad esterified) in type 2 diabetes     patients without a previous history of cardiovascular disease.   "
241876|NCT01010048|"     The purpose of this study is to compare the stone clearance rate treated with different drugs     after ESWL in urinary calculus,These drugs are often used in urinary calculus,such as     progesterone,tamsulosin,propantheline Bromide and nifedipine.In these study the investigators     want to investigate different effect of these drugs use to treat urinary calculus after ESWL.   "
241877|NCT01010061|"     This open-label, randomized, 3-arm study will evaluate the efficacy and safety of     obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus     chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic     leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles     of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and     day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or     rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil,     or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for     disease-progression and safety will be at least 5 years. In the US, this trial is     sponsored/managed by Genentech.   "
241878|NCT01010074|"     Parkinson's disease (PD) is a neurodegenerative disorder characterized by muscle rigidity,     tremor, a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of     physical movement. The primary symptoms are the results of decreased stimulation of the motor     cortex arising from the basal ganglia normally caused by the insufficient formation and     action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary     symptoms may include high level cognitive dysfunction and subtle language problems. Included     in the symptomatology experienced by patients with PD, visual abnormalities are not uncommon.     Visual changes among patients with PD appear not only dynamic in nature, but differentially     affected based on the course of the disease and, perhaps more importantly, its treatment.     Parkinson's disease has significant ramifications not only in observation of irregularities     in vision, but how vision interacts with entrainment of the circadian clock. The purpose of     this study is to examine the relationship between PD and operation of a unique set of retinal     cells known to regulate the circadian clock and sleep-wake cycles in human subjects.   "
241879|NCT01010087|"     Primary Objectives:      The primary objective of the trial is to compare the antiviral efficacy of a 10 day course of     standard (75 mg bid) and high-dose (225 mg bid) oseltamivir (or equivalent doses in     mild-moderate renal failure) in the treatment of severe influenza infections.      The hypothesis is that high dose oseltamivir will increase the proportion of patients with     negative reverse transcriptase (RT)-PCR detection of influenza viral RNA (and viral culture,     at selected sites) at Day 5 post-treatment.      An important secondary objective of the trial, which reflects the main clinical objective, is     to determine the difference in the numbers of ventilator days between the standard-dose and     high-dose groups   "
241880|NCT01010100|"     The purpose of the study is to determine if the administration of small doses of Acarbose can     prevent or delay the appearance of Type 2 Diabetes Mellitus in a population of subjects with     prediabetes.   "
241881|NCT01010113|"     In this study the investigators want to evaluate the satiety of two infant formulas, one     containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy     measurement for the healthy development of an infant, will be assessed in both groups and     compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non     inferiority.   "
241895|NCT01010295|"     Patients with mucosa-associated lymphoid tissue (MALT) lymphoma of the ocular adnexae (MLOA)     will be eligible for treatment with doxycycline (part A: clinico-pathological study);     patients with other types of ocular lymphoma, inflammatory lesions or those     ineligible/unwilling for treatment with doxycycline can participate in the only pathologic     study (part B).   "
241882|NCT01010126|"     This phase II trial studies how well temsirolimus and bevacizumab work in treating patients     with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of     cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may     kill more tumor cells.   "
241883|NCT01010139|"     The objective of this study designed to characterize the pharmacokinetics and comparative     bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of     60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.   "
241884|NCT01010152|"     The objective of this study was to assess the comparative bioavailability of codeine from     Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with     codeine phosphate 30mg) under fasted conditions   "
241885|NCT01010165|"     Septic arthritis is a frequent, potentially disabling and/or life-threatening disease. To     diagnose a septic arthritis is a complex procedure, first because of numerous differential     diagnoses (such as crystal arthritis), second because of poor sensitivity of initial gram     staining (for example after untimely antibiotic therapy).      This protocol will use SELDI-TOF as a tool to analyse joint fluid of patients with various     acute, polymorphonuclear-rich arthritis, as to determine specific and sensitive new     biomarkers of a septic origin.      Such biomarkers will allow rapid diagnosis of septic arthritis in the first hours of     admission.   "
241886|NCT01010178|"     Critical combination of various approved drugs in management for patients suffering with     COPD.   "
241887|NCT01010191|"     Irritable bowel syndrome patients will be given either placebo pill or no treatment for a     period of 3 weeks.   "
241888|NCT01010204|"     The investigators' hypothesis is that add-on varenicline will be effective (versus placebo)     in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who     are motivated to quit smoking within four weeks. This primary outcome will be assessed from     randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the     investigators also hypothesize that varenicline will prevent relapse in the subsequent     12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the     effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as     well as its safety for use in stable bipolar patients when used as an add-on treatment for     smoking cessation.      The investigators plan to test these hypotheses by conducting a randomized,     placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed     with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up     with them three months later to evaluate extended abstinence.   "
241889|NCT01010217|"     The goal of this clinical research study is to learn about the safety of giving a stem cell     transplant from a tissue-mismatched donor, followed by cyclophosphamide, to patients with     certain types of blood disorders or blood cancers. Melphalan, thiotepa, and fludarabine will     also be given before the transplant.      Researchers will study the health status of these patients at 3 months after the transplant.   "
241890|NCT01010230|"     Treatment for childhood cancer interferes with normal bone maturation such that maximal peak     bone mass may never be attained by some survivors of childhood cancer. In childhood cancer     survivors, a randomized trial evaluating the effectiveness of vitamin D and calcium     supplementation among ALL survivors is currently underway; however, few other interventions     have been offered for this at risk population. Recent evidence demonstrates that low     magnitude; high frequency mechanical stimulation can improve bone quantity and quality,     perhaps providing an alternative or adjunct to pharmacologic intervention in populations     where additional medications are either contraindicated or not acceptable to the individuals     at risk. This application proposes a prospective double blind randomized clinical trial of     low magnitude, high frequency mechanical (LMHF) stimulation for childhood cancer survivors     whose bone mineral density is one or more standard deviations below the mean for their age     and gender.   "
241891|NCT01010243|"     To investigate the effect of an anti-inflammatory therapy consisting of lenalidomide in     combination with pioglitazone, dexamethasone and metronomic low-dose chemotherapy with     treosulfan on the response rate in patients with relapsed or refractory or progressive     multiple myeloma(MM).      Phase I: to determine the lenalidomide dse for the phase II part (5 mg or 10 mg or 15 mg) on     the basis of dose-limiting toxicities (DLTs') in the first 4 weeks of treatment.      Phase II: to determine        -  response rate (primary objective)        -  time to progression (TTP)        -  time to partial response (TPR)        -  overall survival (OS)        -  quality of life        -  tolerability and safety   "
241893|NCT01010269|"     The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard     Complete Knee System in Asian population in terms of early range of motion (ROM), clinical     outcomes, and kinetic and kinematic characteristics in relation to healthy knees.   "
241894|NCT01010282|"     This study will evaluate the safety, efficacy, and acceptability of two artificial tears     compared to a currently available artificial tear in subjects with dry eye.   "
241896|NCT01010308|"     The purpose of this study is to explore the efficacy and safety of Nadolol in hemangiomas of     infancy.      The secondary objective is to assess the feasibility of conducting a randomized controlled     trial comparing nadolol with corticosteroids and propranolol.   "
241952|NCT01016379|"     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how well patients will respond     to treatment.      PURPOSE: This research study is looking at DNA in blood and bone marrow samples from young     patients with acute lymphoblastic leukemia.   "
241966|NCT01016561|"     Rationale: Computer systems that allow doctors to create a 3 dimensional (3-D) picture of the     tumor may help in planning radiation therapy and may result in more tumor cells being killed.     Specialized radiation therapy that delivers a high dose of radiation directly to the tumor     may kill more tumor cells and cause less damage to normal tissue. Drugs, such as cisplatin,     may make tumor cells more sensitive to radiation therapy.   "
241899|NCT01010347|"     Background: distal radial buckle fractures are common injuries in children. the ideal     immobilization technique is controversial. Few, retrospective studies have been conducted to     evaluate bone healing after casting versus splinting. However, the impact of the     immobilization technique on daily function and comfort has not been evaluated.      Objective: To compare the impact on daily function, comfort and satisfaction of casting     versus splinting in children with distal radial buckle fractures.      Primary Hypothesis: Children with short arm casts to immobilize a distal radial buckle     fracture will have a greater reduction in daily activities compared to those immobilized with     a volar splint.      Secondary Hypothesis: Children who are immobilized in a short arm cast will have less pain,     less patient/parental satisfaction, more adverse effects, fewer follow-up visits, longer     emergency department (ED) treatment time. Furthermore, we hypothesize that all fractures will     have acceptable alignment/healing at the follow-up orthopaedic clinic evaluation.   "
241900|NCT01010360|"     Computer-aided image recognition will improve the technique of endoscopic ultrasound-celiac     plexus block/celiac plexus neurolysis (EUS-CPB/CPN) and improved pain relief.   "
241901|NCT01010373|"     The purpose of this study is to determine whether addition of AS101 to the standard     chemotherapy regimen is effective in the treatment of newly diagnosed elderly (≥60) AML     patients and AML transformed myelodysplastic syndrome (MDS) patients.   "
241902|NCT01010386|"     Primary Aim        -  Evaluate whether human embryo exposure to physiologic levels of oxygen during culture          improves the percentage of women who deliver a baby following in vitro fertilization and          embryo transfer.      Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates     the oxygen tension in the fallopian tube and uterus, improves live birth rate in clinical In     Vitro Fertilization Embryo Transfer (IVF-ET).      Secondary Aims      Evaluate whether human embryo exposure to physiologic levels of oxygen during culture during     in vitro fertilization and embryo transfer        -  improves embryo cleavage        -  improves clinical pregnancy rate        -  reduces multiple pregnancy rate        -  reduces miscarriage rate      Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates     the oxygen tension in the fallopian tube and uterus, improves embryo cleavage and clinical     pregnancy rates and reduces miscarriage rates in clinical IVF-ET.   "
241903|NCT01010399|"     In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a     switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result     in 30% of patients achieving a reduction in fasting triglycerides < 200 mg /dL while     maintaining virologic suppression.   "
241904|NCT01010412|"     Hypothesis and Specific Aims:      The investigators hypothesize that ultrasound (US) visualization is as effective as nerve     stimulation (NS) for identification of peripheral nervous structures and may be associated     with less trauma and patient discomfort. Specifically, the investigators believe that     equivalent rates of surgical anesthesia are achievable with non-invasive ultrasonic needle     guidance in comparison to needle guidance by intensity of motor fiber response to     intermittent electrical nerve stimulation. Specifically, the number of needle sticks to     identify the brachial plexus and total time to plexus sheath injection may be reduced while     achieving similar efficacy rates. The investigators hypothesize that similar composite safety     and efficacy endpoints but improved patient satisfaction and acceptance will favor US over NS     guidance of nerve blocks indicated for surgery on the extremity surgery. However, the     investigators believe that an economic assessment based upon capital hardware investment,     operating room utilization, total block time, and pay for performance patient satisfaction     metrics require examination prior to assimilation of new technology into clinical practice.   "
241905|NCT01010425|"     Double-blind, randomized, placebo and active controlled dose-ascending study to investigate     safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).   "
241906|NCT01010438|"     The study is designed to compare the apnea event recognition capability of the Capnostream 20     with investigational software to polysomnograph recordings scored by a trained analyst. The     study will compare the apnea index score (AI) calculated by the Capnostream 20 algorithm     based on capnography to that calculated by a trained analyst evaluating polysomnograph     recordings.      To this aim, subjects will be connected to EMBLA N7000 Polysomnograph, and to the Capnostream     20, in order to monitor CO2 and SpO2 during routine overnight sleep studies.      The Capnostream, using both its USB Data Port and Analog output port will simultaneously     provide the monitored data both to a USB flash memory device and Polysomnograph for storage     for future analysis.      The data collected by the Polysomnograph including the Capnostream data will be analyzed by a     trained expert for evaluation of apnea events obtained from both sources.      In parallel, the Capnostream data as collected with the USB flash memory, will be downloaded     onto a PC, and using the Oridion software algorithm designed for evaluating the data (to be     implemented in the monitor when validated), the Apnea Index and Oxygen Desaturation Index     will be calculated. The results of the Apnea Index scores calculated from the Polysomnograph     and from the DUT will be compared.      Based on the results, the study will then evaluate the ability of the     Capnograph/Pulse-Oximeter as a tool for screening and assisting in the diagnosis of patients     with obstructive sleep-apnea in the hospital environment, where it is being used as a     ventilation monitor based on the demonstration of a high correlation with the gold standard     in the sleep lab.   "
241907|NCT01010451|"     There is a lack of evidence of the long-term successful outcomes of antimicrobial endodontic     treatment for primary teeth. This study intended to evaluate (by survival analysis) the     effectiveness of an antimicrobial pulpotomy (chloramphenicol, tetracycline, zinc     oxide/eugenol) in primary molars compared to calcium hydroxide pulpectomy, testing the     hypothesis that antimicrobial pulpotomy could be an alternative pulp therapy for primary     teeth with pulp inflammation or necrosis.   "
241908|NCT01010464|"     The purpose of this study is to determine whether an adhesion reduction plan, consisting of     early adhesion prevention and application of a bioresorbable membrane is effective in     reducing the severity of adhesions and the incidence of complications in managing the open     abdomen in trauma and emergency general surgery.   "
241979|NCT01016730|"     This pilot, phase I trial studies the side effects and best dose of bortezomib in treating     patients with acquired immune deficiency syndrome (AIDS)-related Kaposi sarcoma that has come     back or has not responded to treatment. Bortezomib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
241909|NCT01010477|"     This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine     nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The     objectives of this study are to determine the efficacy of NNS with behavioral intervention     for smoking cessation in smokers with schizophrenia. It is hypothesized that the quit rate of     subjects who receive NNS and behavioral intervention will be significantly greater than the     quit rate of the control group who will receive the placebo spray plus same behavioral     intervention. Quit rate is defined as the proportion of individuals who self report no     tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10     parts per million during these 4 weeks. The investigators will also assess abstinence rates     at Study Weeks 12 and 20 on the NNS and at weeks 26 and 52 after the medication has been     stopped. Since studies of this group suggest high relapse rates when treatments are     discontinued (Evins et al., 2005; George et al., 2000; George et al., 2002a), the     investigators will continue NNS treatment for a total of 20 weeks.   "
241910|NCT01010490|"     To determine the differences in intra-operative complications, surgical duration, fluid     usage, corneal thickness and endothelium cell density in eyes undergoing microcoaxial     phacoemulsification (MCP) either with Torsional or longitudinal ultrasound during the surgery     and at post-operative day 1, 1 month and 3 months.   "
241911|NCT01010503|"     This open-label, single-arm, non-randomized study will evaluate the adherence and persistence     to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who     have an inadequate clinical response to non-biologic DMARDs. Patients will receive     tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with     methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time     of study treatment is 6 months. The target sample size is 20-50 patients.   "
241912|NCT01010516|"     Statin therapy does not fully eliminate the cardiovascular disease (CVD) risk associated with     low high density lipoprotein-C (HDL-C) and high triglyceride levels. It is currently unknown     what would be the best treatment option for patients with mixed hyperlipidemia who fail to     meet their lipid targets with statin monotherapy at conventional does, i.e. high dose     rosuvastatin or conventional statin dose plus micronized fenofibrate or conventional statin     dose plus niacin/laropiprant. The aim of the present study is to compare the efficacy of     high-dose rosuvastatin vs conventional statin dose plus micronized fenofibrate vs     conventional statin dose plus extended-release niacin/laropiprant on lipid profile in     patients with mixed hyperlipidemia. The primary efficacy endpoint will be changes in     non-HDL-C levels at 6 months after treatment initiation.   "
241913|NCT01010529|"     The purpose of this study is to determine the feasibility of a RCT evaluating the     effectiveness of occupational therapy in Parkinson's disease.   "
241914|NCT01010542|"     The purpose of this research study is to evaluate the safety and tolerability of ILV-095 when     it is given to individuals with moderate to severe chronic plaque psoriasis. Another purpose     of the study is to observe how the drug enters the blood and tissues over time, how the body     breaks down the drug and whether or not the body will develop an immune reaction     (sensitivity) to the drug.   "
241915|NCT01010555|"     The purpose of this study is to investigate the front surface wettability of soft contact     lenses while on eye.   "
241916|NCT01010568|"     The purpose of this study is to evaluate the safety and effectiveness of the combination of     bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia     and small cell lymphoma. All subjects enrolled on this study will receive both drugs by     intravenous (IV) infusion.   "
241917|NCT01010581|"     The purpose of the study is to determine the efficacy, safety and pharmacokinetics of SC12267     (4SC-101, 35 mg) in combination with methotrexate in comparison to methotrexate alone in the     treatment of patients suffering from Rheumatoid Arthritis.   "
241918|NCT01010594|"     It has been questioned whether patients with type 2 diabetes who are advised to restrict     their fruit consumption to two or less pieces of fruits daily have better outcomes (HbA1c,     body weight, fruit intake and serum lipids) after three months compared to patients with type     2 diabetes who are advised to eat at least two pieces of fruits.      To the investigators' knowledge, no randomized controlled trial has evaluated this.      The investigators therefore perform a randomized controlled trial including 76 patients with     type 2 diabetes to investigate this.      The investigators' hypothesis is that:      Type 2 diabetics who are advised to restrict their fruit consumption have the same Hba1c     three months after an initially dietary treatment as type 2 diabetics who are advised not to     restrict their fruit consumption.   "
241919|NCT01010607|"     Upper limb paralysis following stroke is a very common problem. Only 30% of stroke patients     who suffer from upper limb paresis experience a full recovery of function. There is a need     for the development of more efficient rehabilitation methods for the improvement of the     paralysed upper limb function.      It has been shown that the use of mirror therapy after a stroke induces the activation of     motor, sensory and associative regions in the affected hemisphere and is associated with an     improvement in the function of the affected limb. Mirror therapy is a treatment modality in     which the affected arm is hidden from the patient's sight; the patient is instructed to watch     the reflection of his healthy hand on a mirror while he performs movements with his healthy     hand and tries to move simultaneously his affected hand. This induces the illusion that his     affected hand moves well.      It has also been shown that applying vibration to a muscle tendon at frequencies between     50-100 Hz induces an illusion of elongation of the vibrated muscle, if visual feedback is     prevented. For instance, vibrating the triceps will induce a strong illusion of elbow     flexion.      In the present study the investigators will couple the use of a mirror with the application     of vibration to tendons, in order to obtain a multisensorial and strong illusion of movement     in the paralyzed limb.      The study hypothesis is that the administration of mirror therapy together with vibration     will induce the activation of multiple motor, sensory and associative areas in the affected     brain hemisphere, resulting in improvement of the affected upper limb function, compared to     the administration of mirror therapy alone or sham therapy.   "
241920|NCT01010620|"     The Screening Protocol is a system devised to evaluate potential research participants for     National Institute on Drug Abuse/Maryland Psychiatric Research Center (NIDA/MPRC) studies.   "
241925|NCT01010685|"     The benefits of laparoscopic (minimally invasive or keyhole) surgery for gallbladder     removal (cholecystectomy) over open surgical procedures in terms of significant reductions in     pain, scarring and recovery time are well accepted. In a conventional laparoscopic     cholecystectomy however, the excised gallbladder still has to be extracted through the     abdominal wall skin via a laparoscopic port site using an incision of 10mm or greater.     Despite being much smaller than that required for open surgery, this incision is painful,     leaves a scar and can result in a port site hernia to follow requiring further surgery to     repair it. Recent attempts to further reduce the invasiveness of the surgical procedure have     suggested performing the operation via an endoscope passed through the mouth and through an     incision in the stomach wall - so called Natural Orifice Translumenal Endoscopic Surgery     (NOTES). Unlike a skin incision, an incision in the wall of the stomach (gastrotomy) should     give no pain, visible scar or herniation risk yet still allow access to the peritoneal cavity     for surgical procedures such as cholecystectomy. Against this, it has the potential risks of     contamination and leakage of gastric contents into the peritoneal cavity. Whilst the     limitations of present technology make it very difficult to perform an entire cholecystectomy     through the stomach wall in patients, endoscopic methods for closing a gastrotomy are     available that are approved for use in patients (CE marked) and it is hypothesised that     removing the excised gallbladder through the stomach in this way would avoid the problems of     extracting it through the abdominal wall described above. Data are required to determine     whether the extraction of the gallbladder via a gastrotomy rather than through the skin is     safe, producing smaller scars and a better cosmetic result. A secondary endpoint would be to     assess possible reductions in pain and recovery from this less invasive approach.   "
241926|NCT01010698|"     The Biopharmaceutics Classification System (BCS) is employed by the US FDA to categorize drug     substances into 4 classes and to characterize drugs in terms of aqueous solubility and     intestinal permeability. The four BCS categories for a drug substance are Class 1, Class 2,     Class 3, and Class 4. Biopharmaceutical properties of aqueous solubility and intestinal     permeability with drug product dissolution determine the rate and extent of drug absorption     from immediate-release (IR) and solid oral dosages forms (e.g. tablets,capsules). Each class     exhibits information regarding biopharmaceutic properties and bioequivalence. For example,     Class 1 drugs have the most favorable oral biopharmaceutic properties (high solubility and     high permeability). With these biopharmaceutic properties for class 1 drugs, results in vivo     bioequivalence (BE) studies for rapidly dissolving IR solid oral dosage forms the FDA     provided waivers. This approach alone has resulted in new and generic drugs approved based on     vitro data alone (i.e. biowaived), with great savings in resources and reduction in     unnecessary human testing.      Objectives: 1) The primary objective of this study is to assess whether common excipients     cause bioinequivalence of Class 3 drugs. 2) The secondary objective is the results of the     study will contribute towards providing scientific evidence to the FDA for consideration of     Class 3 drugs for BCS-based biowaivers.      Hypotheses: The investigators anticipate that common excipients do not cause     bioinequivalence. 1) Hence, the hypothesize of this study is commonly used excipients in oral     medications (tablets, capsules) modulate the rate or extent of Class 3 drug absorption and     result in bioinequivalence. 2) Alternative hypothesis is that commonly used excipients in     oral medications (tablets, capsules) do not modulate the rate or extent of Class 3 drug     absorption and do not result in bioinequivalence.   "
241927|NCT01010711|"     Migraine in children and adolescents can be associated with low serum levels of coenzyme q10,     the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an     important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults     it is hypothesized that daily supplementation of coenzyme q10 as well as different     antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to     reduce the days with migraine as primary parameter (open clinical trial).   "
241928|NCT01010724|"     The study drug bIAP, or matching placebo, will be administered as a bolus of 1000 Units bIAP     or matching placebo prior to anaesthesia (T = -15 minutes), directly followed by intravenous     continuous infusion of about 5.6 units per kg bodyweight/hr at pump rate 4 ml/hr for     approximately 36 hrs (total 200 IU/kg/36 hrs) into each of a total of 50 patients scheduled     for coronary artery bypass graft surgery (CABG). Risk of surgical complications and mortality     due to co-morbid conditions will be collected and the EuroSCORE will be used to screen     patients prior to surgery.   "
241929|NCT01010737|"     This is a phase I/II, randomized, single-blind, placebo-controlled escalating double-dose     study of the safety and priming potential of an intramuscular Influenza vaccine     (Multimeric-001) injected to elderly volunteers.   "
241930|NCT01010750|"     To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based,     battery of neuro-psychometric tests in adults with ADHD.   "
241931|NCT01010763|"     The purpose of this study includes the investigation of Metal-ion release and Renal Function     analysis in M2a Total Hip Arthroplasty.   "
241932|NCT01010776|"     The purpose of this study is to evaluate effectiveness, tolerability (how well a participant     can stand a particular medicine or treatment), and safety of flexible-dose of paliperidone     extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms     of emotional instability, detachment from reality, often with delusions and hallucinations,     and withdrawal into the self), previously taking risperidone (an antipsychotic), but who are     not satisfied with their treatment.   "
241933|NCT01010789|"     The purpose of this research study is to study the effectiveness, tolerability and safety of     armodafinil in outpatients with binge eating disorder.   "
241934|NCT01010802|"     The purpose of this study is to determine whether recombinant human Erythropoietin (EPOrh) is     safe in the treatment of patients with Parkinson's Disease.   "
241935|NCT01010815|"     The researchers will investigate gut microbiome in Korean patients with ulcerative colitis     and normal control subjects using metagenomic analysis to elucidate the significant     difference between two groups This study will help to understand the association between gut     microbiome and inflammatory bowel disease.   "
241936|NCT01010828|"     This study will show whether Tri-Vector method can ensure more extensive visual field and     conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types     of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in     Vanguard PS artificial knee joint total replacement observational period before and during     surgery.   "
241937|NCT01010841|"     The objective of this study was to investigate from 3 sites (University of Connecticut,     University of Florida, and University of California, Irvine) whether enhancement of a     modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy     protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) could improve     cardiometabolic risk factors in women with metabolic syndrome.   "
241950|NCT01016353|"     This study is being done to gather data that will be used to compare two different TAC     (Temporary Abdominal Closure) methods that your doctor may use. The two TAC methods being     compared are the Barker's vacuum packing technique or BVPT and the Open Abdomen Negative     Pressure Therapy System (ABThera) developed by the sponsor of this research (KCI, San     Antonio, TX). The BVPT is made up of supplies that are stocked in most surgery rooms. The     ABThera dressing is available commercially. Neither method will be supplied to the doctor     (Principal Investigator), so that in no way would the subject's standard of care be different     from what they would get if the study was not being done.      This study is observational and only collects data about how the subject progresses after     surgery TAC is used. When a study is observational it means that the subject's standard     medical care will not be altered in any way, simply watched. The doctor will not change     treatment of your open abdomen.   "
241938|NCT01010854|"     The drugs FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) are one of the approved     options to treat Locally Advanced or Primary Metastatic Breast Cancer. In this study, the     investigators will add another drug called Valproic Acid (VPA) to see whether this makes the     treatment better. The addition of Valproic Acid to chemotherapy has been studied in about 65     subjects with cancer and was found to be safe and tolerable. Valproic Acid is approved by the     Food and Drug Administration (FDA) for the treatment of seizures, mood swings, and migraine     headaches. It is not currently approved for cancer, which is why the investigators are     conducting this study.      The results of a Phase I study of Valproic Acid and FEC100 in subjects with cancer that has     spread has led the investigators to believe that this combination is better than just the     standard treatment alone. The investigators are now testing the combination in a study with     subjects who have either a large tumor, many lymph nodes involved or patients whose tumor has     spread. In addition to the treatment, a main goal of the study is to find out which subjects     will benefit from this combination. In the Phase I trial the investigators noticed that while     this combination appears to make the chemotherapy more effective, it did not appear to cause     more side effects induced by the chemotherapy.   "
241939|NCT01010867|"     Primary Objective:      1. To evaluate the safety of orally administered Lactobacillus plantarum strains 299 and     299v, a probiotic, in patients undergoing allogeneic myeloablative HSCT, as measured by     incidence of Lactobacillus plantarum bacteremia.      Secondary Objectives:        1. To investigate the feasibility of administering Lactobacillus plantarum 299 and 299v to          children and adolescents undergoing HSCT.        2. To describe the overall incidence of bacteremia in HSCT patients who have been          administered Lactobacillus plantarum.        3. To describe the overall incidence of acute graft versus host disease (GVHD) in HSCT          patients who have been administered Lactobacillus plantarum.   "
241940|NCT01010880|"     BKT-140 drug substance is a highly selective chemokine receptor (CXCR4) antagonist, which is     developed by Biokine as a novel therapy for Multiple Myeloma (MM, a type of blood cancer).     The unique combination of activities of BKT140, i.e., the induction of the exit of blood     cells such as stem cells and mature cells from the bone marrow to the peripheral blood,     coupled with specific induction of MM cell death by BKT-140, represents a novel therapeutic     strategy against MM.   "
241941|NCT01016223|"     The investigators hypothesize that swallowed beclomethasone leads not only to improvement of     symptoms and decreased number of eosinophils in esophageal mucosa, but also to a decrease in     other markers of tissue inflammation like mast cells, CD4+ T lymphocytes, IL4, IL-5, IL13,     GM-CSF and TGF-beta as well as serum ultra-sensitive C-Reactive Protein (CRP). The     investigators aim to characterize the response of esophageal inflammation to swallowed     topical glucocorticoids, and identify biomarkers to assess response to treatment.      This research will elucidate the effect of treatment with beclomethasone on various     inflammatory markers in EoE, which is currently not well-understood. This work will explore     the pathophysiology of EoE, and has the potential to find a non-invasive biomarker such as     high-sensitivity CRP that can be used to monitor the response to treatment.   "
241942|NCT01016249|"     The investigators reasoned that a hypertonic saline concentration higher than 3% could be     safe and more efficacious in the treatment of bronchiolitis, alleviating severe symptoms and     preventing the need for hospitalization in some instances.   "
241943|NCT01016262|"     Hypothesis: The responder rate of the MAX-002 will be superior to placebo after 6 weeks of     treatment in patients with mild to moderate ulcerative proctitis.      Summary: The primary purpose of this study is to evaluate the efficacy and safety of new     mesalamine suppositories (MAX-002) as compared to placebo after 6 weeks of treatment in     adults with mild to moderate ulcerative proctitis.      Prior to randomization, all inclusion and exclusion criteria will be verified to confirm     eligibility. Patients found to be eligible will be randomized in a 1:1:1 scheme to receive     either MAX-002 1 g, Canasa® 1 g, or Placebo suppository once daily at bedtime for 6 weeks in     a double-blind fashion. Completers at Study Week 6 will be offered to receive MAX-002 1 g     suppositories on a voluntary basis during the next 8 weeks of the open-label phase.     Regardless of the treatment groups, all patients will be evaluated through phone calls at     Study Weeks 1 and 2 followed by clinical visits at Study Weeks 3, 6, and 14. Study-specific     procedures include but are not limited to the following: flexible proctosigmoidoscopy;     disease activity assessment; smoking habits description; health-related quality of life;     compliance to treatment check and safety evaluations (physical examinations, ECG, vitals     signs, clinical laboratory analyses). All patients will complete daily diaries and will be     asked general open questions about any occurrence of adverse events/concurrent medical     conditions, use of adjunctive therapy/procedure, and their intake of concomitant medication.   "
241944|NCT01016275|"     The objective of this clinical study is to evaluate, in a controlled setting, the long-term     (up to 24 months) outcome of the self-expanding nitinol rapid-exchange Misago (Terumo) stent     in TASC A and B iliac lesions.   "
241945|NCT01016288|"     The aim of the study is to compare the performance characteristics of EUS-FNA 22 Gauge needle     and EUS FNA 25 Gauge needle in terms of cellularity and diagnostic yield for diagnosis of     various pathologies, including lymph nodes, pancreatic, luminal and other lesions outlined by     EUS.   "
241946|NCT01016301|"     The aim of the present study is to evaluate effects of a clinical pharmacist service on     health-related quality of life and prescribing of drugs.   "
241947|NCT01016314|"     This is a multi-center, prospective randomized clinical study to evaluate the clinical     outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental     posterior fixation using ASPEN Spinous Process System compared to pedicle screw     instrumentation.   "
241948|NCT01016327|"     The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase     inhibitor, in adult patients with advanced solid tumors.   "
241949|NCT01016340|"     This is a phase II randomized, double-blind, placebo-controlled study where eligible     subfertile male subjects (age 20 years).   "
241951|NCT01016366|"     The primary purpose of the study is to determine whether carbamylated erythropoietin is a     safe treatment for patients who suffer from Friedreich's Ataxia.   "
242057|NCT01024660|"     The purpose of this study is to determine if there is improvement or measurable change in     cognition after only one month of treatment with donepezil when using a computerized test     battery. The results at one month will be compared with the results at 3 months to evaluate     this.   "
241953|NCT01016392|"     Kuvan® is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4). BH4 is     required by the body to use an amino acid called phenylalanine in order to build another     substance called tyrosine.      Kuvan® received marketed authorisation in Europe in December 2008 and is now available in     several European countries for the treatment of Hyperphenylalaninemia (HPA).      The primary objective is to assess the long-term safety in subjects treated with Kuvan®.      Secondary objectives are to provide additional information regarding:        -  Safety in specific subject groups (elderly, pediatric, pregnant women and subjects with          renal or hepatic insufficiency).        -  Growth and neurocognitive outcomes for subjects with hyperphenylalaninemia (HPA) who are          receiving treatment with Kuvan®.        -  Progress and outcome of pregnancy for women with HPA who become pregnant while receiving          treatment with Kuvan® (these women will be enrolled in a dedicated sub-registry).        -  Assessment of adherence to diet and to Kuvan®.        -  Assessment of long-term sensitivity to Kuvan®treatment.   "
241954|NCT01016405|"     This study will determine the incidence and severity of dry eye in patients undergoing     cataract surgery as determined by grade on the International Task Force (ITF) scale.   "
241955|NCT01016418|"     Trial Synopsis: Bovine Colostrum for patients with non alcoholic fatty liver disease (NAFLD).      Design: This is a single-arm, open-label, before-and after exploratory trial of 30 days of     Bovine Colostrum Powder (BCP) to improve NAFLD and the metabolic syndrome.      Duration: 8 weeks per subject.      Sample Size: 30 subjects.      Population: Patients with biopsy proven NASH (NAS of > 4) and an ALT level of ≥ 30 (U/L).      Regimen Study treatment will consist of BCP, three 1.2 g oral tablets (equivalent to 600 mg     of BCP each) for 4 weeks, from cows immunized to insulin. Patients will be followed for     safety monitoring for an additional 4 weeks.   "
241956|NCT01016431|"     Chronotropic incompetence consists of an insufficient increase in heart rate during effort,     and its presence is recognized as a common feature in patients with heart failure due to left     ventricular systolic dysfunction, apparently suggesting a worse prognosis. Little is known     about the possible benefits of its reversal in such patients.      The investigators working hypothesis is that the modulation of chronotropic response, as     obtained by means of atrial rate-adaptive pacing may improve functional capacity in persons     with chronic heart failure and chronotropic incompetence.      To explore this hypothesis,the investigators will enroll 20 patients with NYHA II/III heart     failure, low left ventricular ejection fraction (<40%) and chronotropic incompetence (Maximal     heart rate <80% of predicted value in a symptom-limited incremental test), who already     underwent implantation of dual-chamber implantable defibrillator for prevention of sudden     cardiac death. The study will have a randomized, double-blind, cross-over design.      The procedures, to be carried out at one month from each reprogramming (VVI backup pacing vs.     AAI-R active pacing), will comprise: blood sampling for NT-proBNP, incremental     symptom-limited cardiopulmonary exercise testing (CPX), constant-workload cardiopulmonary     test (50% of max WR), quality-of-life questionnaire, 24-hour ECG monitoring.      The primary end-point will be peak oxygen consumption on CPX. Secondary end-points will     include acute response to reprogramming, and data derived from constant-WR tests, Holter     monitoring and QoL.   "
241957|NCT01016444|"     The hypothesis to be tested is that acutely ill asthmatics who do not resolve their attacks     following standard doses of albuterol and require admission to hospital have single     nucleotide polymorphisms of their B2 adrenergic receptors that lower B2 agonist responsivity.   "
241958|NCT01016457|"     The purpose of this study is to compare glucose control, quality of life and number of     hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal     hypoglycemia can be missed even when the parents check their children's blood glucose several     times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by     using the sensor in this age group. As a consequence, quality of life of the families will     improve. The investigators also hypothesise that diabetes control will improve at 3-6 months     from the beginning of the study.   "
241959|NCT01016470|"     The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could     improve the progression disease, in patients with Parkinson's Disease (PD).   "
241960|NCT01016483|"     The research trial is testing the experimental treatment MSC1936369B in combination with     Gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. The study will be run in     two parts:      Safety Run-In: Will determine the Maximum Tolerated Dose (MTD) and the recommended Phase II     dose of MSC1936369B, when combined with gemcitabine, in subjects with metastatic pancreatic     adenocarcinoma.      Phase II: Will assess the anti-tumor activity of MSC1936369B combined with gemcitabine     compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic     adenocarcinoma.   "
241961|NCT01016496|"     Evidence exists that the activation of actions activates the same cortical motor areas that     are involved in the performance of the observed actions. The neural substrate for this     phenomena is the mirror neuron system. It is generally assumed that mirror neurons have a     basic role in understanding the intentions of others and in imitation learning. There is     evidence that action observation has a positive effect on rehabilitation of motor disorders     after stroke. The aim of this study is to demonstrate that action observation followed by the     repetition of the actions previously observed has a positive impact on rehabilitation of the     upper limb in children affected by hemiplegia as a consequence of Cerebral Palsy. In     particular, the purpose is to assess if mirror neurons could improve the amount, the quality     and the velocity of movements and the cooperation between the two upper extremities.   "
241962|NCT01016509|"     A multicentric study will evaluate whether peri-procedural tight glycemic control during     angioplasty revascularization for acute coronary syndrome (ACS) reduces circulating     inflammatory cytokines and thrombus formation in hyperglycaemic patients. Moreover, the     investigators will assess whether the tight glycemic control during the first month from     coronary event reduces the incidence of coronary stent restenosis at 6-months from PCI.   "
241965|NCT01016548|"     The purpose of this study is to determine whether adults with hematologic malignancies on     active systemic therapy or shortly after bone marrow transplantation need one or two doses of     adjuvanted vaccine to achieve best possible rates of protection. An additional research     question is whether baseline biomarkers of the cellular and humoral immune systems are     associated with an antibody response to vaccination.   "
241967|NCT01016574|"     The purpose of this study is to evaluate the Giro-couch, an innovative patient support device     for the application of prone RT for treatment of breast cancer. This study will assess the     feasibility of a new positioning approach to facilitate the delivery of external beam,     delivered to the lumpectomy cavity, (the boost dose, partial breast therapy).   "
241968|NCT01016587|"     COPD patients often have a wide range of physical (e.g., dyspnea, fatigue, pain) and     psychological (e.g., depression, anxiety) symptoms and various other debilitating conditions     that cause considerable suffering for the individual. Unfortunately, many of the symptoms and     health problems in patients with COPD are unrecognized and untreated. Due to the irreversible     nature of COPD, the aim is not to cure the disease, but to reduce symptoms and improve     quality of life.      Therefore, the purpose of this project is to investigate the existence and nature of symptom     clusters over time in patients with COPD and their effects on patient outcomes. Since this     study aims to identify possible new subgroups of patients with COPD defined by the clustering     of certain symptoms, the study also aims to investigate the relationship between the clinical     presentation and certain immunologic and genetic factors.   "
241969|NCT01016600|"     Determine toxicity and remission rates of treatment with azacitidine and lenalidomide for     patients with Acute Myeloid Leukemia   "
241970|NCT01016613|"     Chronic kidney disease (CKD) affects approximately 26 million Americans and     disproportionately manifests in specific race and ethnic groups. Patients burdened with CKD     have significant morbidity and reduced life expectancy. In addition to excessive suffering     and lost productivity, the cost of managing this epidemic has reached $40 billion annually.     The recognition that CKD is a major public health problem is reflected in the fourteen     objectives outlined in Healthy People 2020 to begin to address the disease burden.     Advancement in approaches to halt CKD progression has been slow despite growing global     awareness of disease burden.      This O'Brien Kidney Research Core will create opportunities for novel insights through     characterization of tissue profiles that will define new disease markers and molecular     pathways and will be available to all kidney investigators on the www. It will thereby     fundamentally alter the starting point for research into prevention of progression of these     kidney diseases. C-PROBE is an essential element of the center grant and presents a     biomedical resource core consisting of: (1) clinical phenotyping (that is, systematic     identification of observable physical and biomedical characteristics) of kidney disease     patients including the accurate measurement of kidney function; and (2) a specimen BioBank     which will store blood, urine and kidney tissue samples. A key component of C-PROBE is     therefore that it contains a proven mechanism to collect samples from high risk groups     including minorities, at the institutions of University of Michigan Health System, St. John     Hospital, Wayne State University in Michigan, John H. Stroger Hospital in Illinois, Temple     University Health System in Pennsylvania, and Levine Children's Hospital in North Carolina.     This mechanism will feed the other Cores and provide biomedical investigators with approved     projects the access to a dynamic pool of well characterized high risk kidney disease patients     and their biological specimens to conduct high caliber translational research.   "
241971|NCT01016626|"     The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic     characteristics between the CKD-4101 tablet and Mycophenolate mofetil capsule when     administered alone to healthy volunteers.   "
241972|NCT01016639|"     The purpose with this study is to evaluate treatment with radio chemotherapy (oxaliplatin and     capecitabine) given concommitant with radiotherapy in patients with gastrointestinal tumors.     The trial consists ot two separate studies; CORGI-U in patients with stomach- bile ducts-     gallbladder and pancreas cancer, and CORGI-L in patients with colorectal cancer.      CORGI-U will be designed as a phase-I-II-study,in which the first part will be a chemotherapy     dose finding study, followed by a phase II part to establish response rates. All subjects     receives radiotherapy concommitant.      CORGI-L is a phase II trial, in which patients are treated with chemotherapy at fixed doses     with radiotherapy concommitant.   "
241973|NCT01016652|"     The purpose of this study is to evaluate the effect of a multi-focal contact lens on     symptomatic patients.   "
241974|NCT01016665|"     Background: Identification of new biomarkers with potential predictive and prognostic role     has contributed unequivocally to breast cancer treatment.      Although traditionally endocrine therapy is based on hormonal receptors status (estrogen - ER     and progesterone- PR), some patients become hormone resistant. In order to identify a     possible profile associated to hormonal resistance, some biomarkers have been assessed after     short period primary hormone therapy (HT).      Objectives: To compare the expression of Ki-67, Bcl2, Bax, Bak, ER and e PR in postmenopausal     women with ER positive invasive ductal carcinomas (IDC), prior and after tamoxifen and     anastrozole in short term hormone therapy.   "
241975|NCT01016678|"     The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4     sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month     period. They will be required to have three office visits during the six months. All subjects     will be randomized to either Treximet (85mg Imitrex/500mg Naproxen Sodium) or Placebo     (sugar-pill) in four of the five treatment arms with a 3 to 1 ratio. A fifth treatment arm     will treat all 4 migraines with active drug, Treximet. The hypothesis is that Treximet will     prove to be a safe and effective treatment for this population, that has so few treatment for     migraine. And Treximet will be superior over placebo for pain free endpoints at 2 and 24     hours.   "
241976|NCT01016691|"     Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma     or ocular hypertension.   "
241977|NCT01016704|"     The specific aims of the proposed study are to evaluate the effectiveness and     cost-effectiveness of providing monetary incentives to therapists as a method to improve     implementation of evidence-based treatments.   "
241978|NCT01016717|"     To find out the impact of two different proton-pump inhibitors (PPIs) (Omeprazole and     Pantoprazole) on platelet function in patients with stable coronary artery disease (CAD) on     clopidogrel therapy.   "
242058|NCT01024673|"     This is study where medical record information will be collected as well as collection of     excess biological samples.   "
241980|NCT01016743|"     To test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective     and cognitive deficits in patients with asymmetric Parkinson's disease (PD) and to establish     its safety in this population. The investigators anticipate that reaching deeper brain layers     and larger volume of activation with the novel H-coil may induce significantly better     therapeutic effects in patients with PD and will pave the way for establishing a novel and     effective treatment for this disorder.   "
242060|NCT01024699|"     The purpose of this study is to determine differences in the XLIF and TLIF procedures with     respect to perioperative variables in adult patients with low-grade symptomatic     spondylolisthesis.   "
241981|NCT01016756|"     1. PHACE syndrome(OMIM database number 606519) is the association of a vascular birthmark          (hemangioma) on the face along with one or more of the following conditions: congenital          heart defects, congenital anomalies of the cerebral arteries,brain, eyes, or sternum.        2. A research study is currently being conducted at the Medical College of Wisconsin (MCW)          to investigate if there is an inherited cause of PHACE syndrome.        3. We are hoping that this study will lead to a better understanding of how and why          children develop PHACE syndrome.   "
241982|NCT01016769|"     The purpose of this study is to find out the good and bad effects that occur when     temsirolimus is added to standard chemotherapy with carboplatin and paclitaxel.   "
241983|NCT01016782|"     The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the     Treatment of Inflammatory Lesions of Rosacea.      Treatment medication will be administered as follows: A thin film of gel will be applied and     rubbed into the entire face once daily for a period of 70 days.   "
241984|NCT01016795|"     Clinical Hypothesis:      It is expected that by removing chemotherapy and adding ancestim to the mobilization scheme     in most of the subjects sufficient PBPC will be harvested with a minimum of toxicity and side     effects.   "
241985|NCT01016808|"     This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8     mg versus its individual morphine sulfate and oxycodone hydrochloride components for the     management of acute moderate to severe postoperative pain following bunionectomy surgery.   "
241986|NCT01016821|"     Childbirth is one of the most painful events that a woman is likely to experience, and thus     is a major concern for most parturient. Severe pain releases stress mediators and may thus     compromise fetus well-being if placental perfusion is decreased. Epidural analgesia is the     golden standard for the management of severe labor pain. However, it could not always be used     both due the parturient related factors and the organizational reasons.However, the knowledge     on safety and efficacy of oxycodone involving mother, fetus and newborn is limited.      Aim of the study is firstly, to evaluate the efficacy and safety of oxycodone in labor pain     healthy parturients. Secondly, to measure parturient's blood oxycodone concentration during     labour and fetal concentration from placental umbilical vein and artery right after birth.   "
241987|NCT01016834|"     The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel     DosePro to treat their moderate to severe migraines.   "
241988|NCT01016847|"     Obesity is associated with increased airway inflammation and asthma severity that results in     suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS).     The investigators suggested that the addition of Singular (montelukast)[LTRA] to moderate     doses of inhaled corticosteroids will improve asthma control. This cross over study will be     treat subjects with moderate dose ICS/LTRA for 12 weeks and high dose ICS with placebo for 12     weeks.   "
241989|NCT01016860|"     This study plans to learn more about an investigational drug called OSI-906. OSI-906 is being     looked at to see if it could be a treatment for advanced cancer. The FDA is the U.S.     government agency that reviews the results of research of drugs and decides if it can be sold     in the U.S. OSI-906 has been given to over 185 people with cancer.   "
241990|NCT01016873|"     The purpose of this study is to confirm the safety and establish the effectiveness of two     doses from the IRay System for the treatment of wet AMD.   "
241991|NCT01016886|"     While trastuzumab has been shown to prevent recurrences of breast cancer, some women may also     experience damage to their heart muscle (including heart failure) as a result of their     treatment. The investigators hope to learn if standard medications used in heart failure can     prevent heart damage caused by trastuzumab in women with breast cancer. The investigators     would also like to know if there are any ways to detect this damage earlier using magnetic     resonance imaging (MRI) and blood tests.   "
241992|NCT01016899|"     The objective of this study is to record recurrence in patients treated for nonmelanoma     (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic     Brachytherapy System. Additional objectives include evaluate the appearance of the treated     area in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic     Brachytherapy System and record the occurrence of radiation therapy related skin changes in     patients treated for nonmelanoma skin cancer.   "
241993|NCT01016912|"     The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well     tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the     treatment of hepatitis C virus genotype 1 in chronically infected patients who are     treatment-naïve and nonresponsive to the standard of care   "
241994|NCT01016925|"     Background: Bacterial colonization of peripheral nerve catheters is frequent, although     infection is relatively rare. With central venous catheters, the tunneling of catheter into     the subcutaneous tissue significantly decreases catheter colonization and catheter-related     sepsis.      Purpose: The aim of this study is to evaluate the incidence of bacterial colonization in     adult patients with femoral tunnelized perineural nerve catheters.      Methods: A total of 338 patients with femoral catheter will be included in the study. The     patients will be randomized to be included in the control group (without tunnelling) or in     the group with catheter tunneled 2-3 cm subcutaneously. After removal, catheter will be     analyzed for colonization (primary outcome). Quantitative culture will be used as described     by Brun-Buisson for intravascular catheters. The site of insertion will be monitored daily     for any signs of infection (secondary outcome).      Perspective: To show the incidence of femoral perineural catheter colonization is low with     subcutaneous tunneling   "
242015|NCT01017211|"     Needle Electromyography (EMG) is an important test used to assess muscle and nerve function,     but the test can be uncomfortable. It is currently not standard practice to provide any     pain-relieving intervention for this procedure. The purpose of this research study is to     determine whether auricular (ear) acupuncture will make EMG testing less painful.   "
242059|NCT01024686|"     The purpose of this study is to assess safety and tolerability of escalating doses of a     genetically attenuated parasite malaria vaccine (p52-/p36- GAP vaccine) in healthy     malaria-naive adults. The study will also assess preliminary efficacy of p52-/p36- GAP     vaccine following primary experimental challenge with P. falciparum sporozoites. Lastly, the     study will assess immunogenicity of p52-/p36- GAP in malaria-naïve healthy adults and     preliminary efficacy of p52-/p36- GAP vaccine following primary experimental re-challenge     with P. falciparum sporozoites.   "
241995|NCT01016938|"     Radiation treatment for each patient with cancer is designed based on CT scans. We know that     tumors in the chest and abdomen move when you breathe. Because of this, there can be     differences between planned treatment and the treatment actually delivered to the body.     Usually with radiation a safety margin is added to ensure that radiation hits the entire     tumor. This can damage healthy parts of the body because the exact location of the tumor is     unknown.      Magnetic resonance imaging (MRI) is a painless and safe diagnostic procedure that uses a     powerful magnet and radio waves to produce detailed images of the body's organs and     structures, without the use of X-rays or other radiation.      The research doctors are studying to see if the position of a tumor can be tracked using MRI     scans and tracking sensors placed on the skin. MRI scans and the tracking system used to     calculate the location and position of the tumor are both FDA approved technologies.      The research doctors will also use the MRI scans to evaluate any changes in your lung     function during and following your radiation treatments.      In this study the participant will undergo a series of MRI scans with and without contrast     dye.      This study is being funded through grants from the National Institutes of Health (NIH).   "
241996|NCT01016951|"     The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and     pharmacodynamics of inhaled AZD9164 following administration of multiple ascending doses in     healthy male and female subjects and COPD patients.   "
241997|NCT01016964|"     The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam     model for androgenetic alopecia in females when treatment is applied as directed.   "
241998|NCT01016977|"     A single-blind (investigator-blinded), randomized, parallel group, single center study to     evaluate the tolerability and efficacy of combination therapy with Duac Gel / 0.1% Tazorac     Cream and Acanya Gel / 0.1% Tazorac Cream for the treatment of facial acne vulgaris.   "
241999|NCT01016990|"     RATIONALE: Valproic acid may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. It may also help cancer cells become more like normal cells, and grow     and spread more slowly.      PURPOSE: This phase II trial is studying how well valproic acid works in treating patients     with previously treated non-Hodgkin Lymphoma, Hodgkin lymphoma, or chronic lymphocytic     leukemia.   "
242000|NCT01017003|"     This open label, single group, sequential dose study will compare the single dose     pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10     days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers.   "
242001|NCT01017029|"     The purpose of this study, in de novo heart transplant patients, is to evaluate whether     delayed introduction of everolimus reduces the occurrence of wound healing problems,     pericardial and/or pleural effusion and early acute renal insufficiency, as compared with     immediate introduction of everolimus, in the firs six months after heart transplantation.   "
242002|NCT01017042|"     This study aims to characterize the pharmacokinetic profile of colchicine after a regimen of     1.8 mg over two hours. A secondary goal is to evaluate the safety and tolerability of this     regimen in healthy volunteers. To this end, all study subjects will be monitored for adverse     effects throughout the entire study period.   "
242003|NCT01017055|"     Evaluate voice and swallowing outcomes post operatively.   "
242004|NCT01017068|"     The purpose of this study is to determine the effect of Aqueous mushroom extract (AME) on     intra ocular pressure (IOP) in humans or as a potential anti glaucoma drug.   "
242005|NCT01017081|"     Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia     however there was no evidence to support a beneficial effect in pediatric patients.   "
242006|NCT01017094|"     This study aimed to compare the efficacy of pin-tract infection prevention between     silversulfadiazine and dry dressing.      Methods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from     September 2007 to June 2008 and treated by emergency debridement and external fixation were     randomized into two groups, one treated with silversulfadiazine for infection prophylaxis     (15) and a control group treated with dry dressing only (15). All patients were followed     until the external fixator was removed. Pin-site infections were assessed and graded at each     follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin     site was done if an infection occurred.   "
242007|NCT01017107|"     Activated protein C (APC)has been shown to reduce mortality in severe sepsis(Bernard et al.     2001b). The clinical picture of severe acute pancreatitis (AP) is similar to that of sepsis.     The investigators conducted a randomised double-blinded placebo-controlled pilot study in AP     patients (16+16) with the same dose of APC that has been proven to be efficacious and safe in     septic patients.      The aim of the study is to investigate whether the APC replacement therapy diminishes the     occurrence and severity of organ dysfunction in patients with severe AP. The effect of APC on     inflammatory and hemostatic parameters is also assessed.   "
242008|NCT01017120|"     The purpose of this study is to assess safety and efficacy of a new foam formulation of     tazarotene in subjects with acne vulgaris.   "
242009|NCT01017133|"     RATIONALE: Diagnostic procedures, such as positron emission tomography, using the drug     fluorine F18-EF5 to find oxygen and fludeoxyglucose F18 to find sugar in tumor cells may help     in planning treatment for patients with non-small cell lung cancer.   "
242010|NCT01017146|"     The purpose of this study is to assess safety and efficacy of a new foam formulation of     tazarotene in subjects with acne vulgaris.   "
242011|NCT01017159|"     The purpose of this study is to determine whether subcutaneous immunoglobulin given in small     doses, is effective in maintaining the force, in patients with chronic inflammatory     demyelinating polyradiculoneuropathy compared with placebo (saline infusions), and     intravenous immunoglobulin.   "
242012|NCT01017172|"     The purpose of this study is to evaluate the immunogenicity and safety of an adjuvanted     A(H1N1)v influenza vaccine in HIV-infected and immunosuppressed patients after one and two     injections.   "
242013|NCT01017185|"     The purpose of this study is to determine whether HF10 is safe and effective in the treatment     of head and neck cancer or solid tumors with cutaneous and/or superficial lesions.   "
242014|NCT01017198|"     This study is designed to assess the effect of food and antacid use on the pharmacokinetic     properties of BIIB021.   "
242016|NCT01017224|"     Solid tumours contain varying degrees of hypoxia. Studies show hypoxia to be associated with     poor local control and survival, as hypoxia is a cause of resistance to radio- and     chemotherapy and the development of a more aggressive tumour.      Previous attempts to measure hypoxia have been biased because the techniques have been     invasive, not repeatable or difficult to apply on a routine basis. There is great interest in     trying to measure hypoxia in tumours as this could lead to individualized hypoxia-modifying     therapy and prediction of treatment response. Additionally the investigators' knowledge of     change in hypoxia over time is limited, but of great interest as individualised treatment,     such as intensity-modulated radiation therapy (IMRT) is emerging.      18F-FAZA, appears promising. It is a nitroimidazole, which gets trapped in hypoxic cells and     can be detected by a positron emission therapy (PET) scan. Compared to other nitroimidazoles,     18F-FAZA has superior biokinetics and thereby is believed to provide a faster and clearer     image of hypoxia.      The investigators' hypothesis is that 18F-FAZA can be used as a prognostic marker in HNSCC.   "
242017|NCT01017237|"     Intravenous sedation is used frequently for the relief of pain and anxiety associated with     oral surgical procedures performed under local anesthesia. The purpose of this study is to     learn about patient and surgeon satisfaction with sedation using Dexmedetomidine in     combination with midazolam alone or with midazolam plus low dose ketamine while having wisdom     teeth removed.      The sedation produced by dexmedetomidine is unique in that it mimics natural sleep, a unique     quality not shared by other drugs. Dexmedetomidine is often used in anesthesia in hospital     operating rooms and has been approved by the US Food and Drug Administration for the use     planned in this study.   "
242018|NCT01017250|"     The purpose of this study is to assess the central nervous system (CNS) toxicity in patients     with recurrent malignant gliomas treated with concurrent Avastin and stereotactic     radiosurgery (SRS).   "
242019|NCT01017263|"     The purpose of this study to assess the effects of chronic administration of Vyvanse     (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with     Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are     obese.   "
242020|NCT01017276|"     This is a multi-center, open-labeled, non-comparative study to examine the safety and     efficacy of ASP1585 in chronic kidney disease and hyperphosphatemia patients on peritoneal     dialysis.   "
242021|NCT01017289|"     The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the     Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.   "
242022|NCT01023867|"     To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and     Mixed Dementia.   "
242023|NCT01023880|"     The primary objective for part 1 of the study is to determine the maximum tolerated dose     (MTD) of CEP-18770 in patients with relapsed and refractory multiple myeloma. The primary     objective for part 2 is to evaluate the antitumor activity of CEP-18770 in patients treated     at the MTD.   "
242024|NCT01023893|"     Prospective, real-time observational study of hemodialysis patients treated with     erythropoiesis-stimulating agents (ESA) to currently recommended Hgb targets. Subjects will     be evaluated dynamically for their blood viscosity status at the beginning and end of the     dialysis treatment, and followed prospectively to assess outcomes. Blood specimens will be     collected via the subject's hemodialysis port pre- and post-hemodialysis per study assessment     visit. Blood will be analyzed at a designated laboratory facility for viscosity over a     comprehensive range of shear rates and tested for intradialytic surges in blood viscosity.     Subjects will be followed for 48 weeks.   "
242025|NCT01023906|"     The purpose of the Taste Perception Study is to assess variations in the ability to taste and     perceive sensations from various stimuli in younger (18-49 years) and older (50-85 years)     volunteers. The study's goal is to determine how these sensations influence what one likes to     eat, and what one chooses to eat, and whether there is an association with dietary intake,     body composition and chronic disease. Another objective of the study is to determine the     association between variations in oral sensations and genes mediating sensory perception and     dietary behaviours.   "
242026|NCT01023919|"     Diabetic patients are prone to a diffuse and rapidly progressive form of atherosclerosis.     Both clinical and angiographic outcomes following percutaneous coronary intervention (PCI)     are poor in patients with DM compared with those without DM. Autopsy study has shown delayed     neointimal healing with inadequate endothelialization and persistent stent surface ﬁbrin     deposition after DES implantation in DM patients. This might partially contribute to the high     risk of late stent thrombosis.      YINYI Polymer-Free paclitaxel stent is a domestic new type stent with bare metal base with     micro porous surface. However, limited data is available in vivo about the surface coverage     after stent implantation in DM patients because of lack of sensitive imaging modalities.     Optical coherence tomography (OCT) is an optical analogue of intravascular     ultrasound（IVUS）that allows high-resolution tomographic intravascular imaging. Furthermore,     several studies have demonstrated the feasibility of OCT to quantitatively evaluate the     surface coverage and stent conditions in the follow up after PCI .      Therefore, the aim of this study was to analyze the surface coverage and late malapposition     after two types of DES implantation in DM patients compared with non-DM patients by using OCT     and IVUS   "
242027|NCT01023932|"     The electrical stimulation generated by the Cochlear Implant (CI) may improve the neural     synchrony and hence contribute to the development of auditory skills in patients with     Auditory Neuropathy / Auditory Dys-synchrony (AN/AD). Goal: The goal of the research was to     evaluate the auditory performance and the characteristics of the electrically evoked compound     action potential (ECAP) in a group of 18 cochlear implants recipients with AN/AD.The auditory     perception was evaluated by sound field thresholds and speech perception tests. To evaluate     ECAP's characteristics, the threshold and amplitude of neural response together with the     amplitude growth and recovery functions were evaluated at 80Hz stimulation rate.The CI was     seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients     considered by the research. The auditory perception benefits as well as the possibility to     measure the ECAP showed that the electrical stimulation could compensate the neural     dys-synchrony caused by the AN/AD. However, a unique clinical procedure cannot be proposed at     this point. Therefore, a careful and complete evaluation of each AN/AD patient before     recommending the Cochlear Implant is advised   "
242031|NCT01023984|"     Objective: Recent non-randomized studies suggest that extended endoscopic submucosal     dissection (ESD) is equally effective in removing large rectal adenomas as transanal     endoscopic microsurgery (TEM). If equally effective, ESD might be a more cost-effective     approach as this strategy does not require expensive equipment, general anesthesia and     hospital admission. Furthermore, ESD appears to be associated with fewer complications. In a     randomized trial we will compare the cost-effectiveness and cost-utility of TEM and ESD for     the resection of large rectal adenomas.      Study design: 15 centers will participate in this multicenter randomized trial comparing TEM     versus ESD.      Study population: Patients with a large rectal adenoma (≥2cm), located between 2 and 15 cm     from the anal verge. Invasive cancer is excluded by histopathology and endoscopic     ultrasonography. Patients must be in a health condition that permits general anesthesia.      Interventions: Patients will be randomized between      a. TEM: under general anesthesia b. ESD under sedation        1. a TEM tube will be inserted in the rectum. With specialized instruments the adenoma will          be dissected en bloc by a full thickness excision, after which the patient will be          admitted to the hospital.        2. an endoscope will be inserted into the rectum and the submucosa underneath the lesion          will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated          Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the          submucosal plane in an eb-bloc fashion, after which the patient will be observed for at          least 24h in-hospital.      Primary Endpoint: incidence of recurrence at 12 months      Secondary Endpoints:      morbidity, subdivided into major (requiring surgery) and minor (requiring endoscopic or     medical intervention) anorectal function. disease specific and general quality of life;     number of days not spent in hospital from initial treatment until 2 years afterwards; adenoma      Sample size: Assuming a comparable baseline recurrence rate for TEM and ESD of 6% and     considering an upper limit of 10% for ESD to be non-inferior (beta-error 0.2 and one-sided     alpha-error 0.05), 60 patients are needed per group. These numbers provide sufficient power     to reveal relevant differences in expected morbidity and in number of days not spent in     hospital.      Economic evaluation: A cost-effectiveness and cost-utility analysis of ESD against TEM for     large rectal adenomas from a societal perspective with respectively the costs per recurrence     free patient and the cost per quality adjusted life year as primary outcome measures.   "
242032|NCT01023997|"     The purpose of this study is to compare the central corneal thickness measurement in patients     with exfoliation syndrome, exfoliative glaucoma, primary open-angle glaucoma, ocular     hypertension and normal controls and to evaluate the value of corneal thickness in the     diagnosis and management of glaucoma.   "
242033|NCT01024010|"     RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such     as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving ofatumumab     together with pentostatin and cyclophosphamide may be a better way to block cancer growth.      PURPOSE: This phase II trial is studying how well giving ofatumumab together with pentostatin     and cyclophosphamide works in treating patients with untreated chronic lymphocytic leukemia     or small lymphocytic lymphoma.   "
242034|NCT01024023|"     Early walking aids are routinely used in UK for rehabilitation of patients with below knee     amputations. The two main walking aids used commonly in practice include the non-articulated     Pneumatic Post Amputation Mobility Aid (PPAM)and the Articulated Amputee Mobility Aid (AMA).     There is no published evidence on whether the articulated walking aid improves knee control     and shortens delivery time. This study was designed to test the hypothesis that an     articulated early walking aid has benefit to transtibial amputee compared to non-articulated     early walking aid.   "
242035|NCT01024036|"     The purpose of this study is to demonstrate that CNTO 328 when administered in combination     with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic     response (complete response or partial response) among patients with Multicentric Castleman's     Disease.   "
242036|NCT01024049|"     The diagnosis of asymptomatic left ventricular dysfunction is difficult in general practice     since it requires transthoracic cardiac echocardiography that is generally performed in     specialized services. Although blood BNP levels monitoring can be of some help in heart     failure diagnosis is is mostly a late biomarker that is secreted upon heart stretch and has     many limitations. Therefore the aim of this study is to identify new specific blood     biomarkers that would help for asymptomatic left ventricular dysfunction diagnosis in large     populations with cardiovascular risk.   "
242037|NCT01024062|"     The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given     weekly in patients with advanced or recurrent non-small cell lung cancer   "
242038|NCT01024075|"     Dexamethasone added to sinufoam, which is placed in the ethmoid cavity at the completion of     endoscopic sinus surgery, will improve sinonasal mucosal healing.   "
242039|NCT01024088|"     To estimate, in a longitudinal and not invasive way, in patients with SGB at respiratory     risk, the function of respiratory muscles and that of the upper airways muscles by     investigating the force of the tongue, the gulp, and the breath during the sleep to be able     to detect bulbar impairment and establish correlations enter the various parameters to     estimate better the interactions between the dysfunction of the respiratory muscles and that     upper airways muscles and so determine the risk acute respiratory failure.   "
242040|NCT01024101|"     The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given     weekly in patients with advanced or recurrent head and neck cancer   "
242041|NCT01024114|"     The purpose of this pilot study is to investigate the potential clinical benefits of     combining two new diagnostic tools to provide co-registered anatomical and functional     information in the breast in patients with suspected breast cancer.   "
242042|NCT01024127|"     This research trial studies deoxyribonucleic acid (DNA) in blood or bone marrow samples from     younger patients with acute myeloid leukemia. Studying samples of blood and bone marrow from     patients with cancer in the laboratory may help doctors learn more about changes that occur     in DNA and identify biomarkers related to cancer. It may also help doctors predict how well     patients will respond to treatment.   "
242043|NCT01024140|"     The primary aim of this pilot study is to test the efficacy of the selective serotonin     re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD)     in an open clinical trial.      A secondary aim is to determine whether treatment with escitalopram increases plasma     allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are     correlated with treatment efficacy.   "
242044|NCT01024153|"     The purpose of this study is to test the effect of active video game play on physical     activity of 9-13 year old children in their natural home environments. We observe how much     physical activity children engage in after receiving two different active Wii video games and     for how long they play. Active video games offer promise of minimizing children's physical     inactivity.   "
242077|NCT01024920|"     Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and     to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).   "
242046|NCT01024179|"     Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent     risk factor for most of acute cardiac event. Current clinical data showed that thin-cap     fibroatheroma was more frequently observed in patients with ACS than SAP. Further OCT study     indicated that patients with ACS had significantly higher incidence of incomplete neointimal     coverage and malapposition after DES implantation than those with SAP. These findings imply     that initial native lesion characteristics may be related to different vessel response     (neointimal coverage and malapposition) after stenting. However, there is little data on the     relationship between plaque characteristics and vascular response to DES after stent     implantation evaluated by OCT.      Therefore, this study was designed to investigate the relationship between initial plaque     characteristics and stent surface coverage or late malapposition after SES implantation. The     investigators will use high resolution OCT to assess the initial culprit plaque morphology     and subsequent vascular response after SES stenting at the time points of post-stenting, 6     months and 12 months. IVUS will also be performed to evaluate the tissue protrusion,     malapposition, vessel remodeling at the same time points.   "
242047|NCT01024192|"     Primary Objective:      To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic     insomnia at the prescription conditions of daily practice      Secondary Objective:      To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as     needed basis.   "
242048|NCT01024543|"     In this study we hypothesize infusion of Angiotensin II improves the insulin-induced     microvascular dilatation and therefore insulin-mediated glucose uptake. Objectives: Does     infusion of Angiotensin II increase insulin-mediated glucose uptake via enhanced     insulin-mediated microvascular function in healthy subjects?   "
242049|NCT01024556|"     The present study is designed as a prospective observational study directed at evaluating the     frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune     response in highly active antiretroviral therapy (HAART)-receiving HIV-1 infected     individuals, and to prospectively evaluate the immunological, virological and clinical     outcome of anti-Tat positive versus anti-Tat negative subjects under successful HAART     (secondary endpoint), in order to determine the impact of anti-Tat immunity on HIV disease     progression as well as the potential use of anti-Tat immune response assessment for the     clinical and therapeutic management of HAART-treated infected patients. This survey provided     important information for the design, planning and conduction of future therapeutic vaccine     trials based on the HIV-1 Tat protein in HAART-treated patients.   "
242050|NCT01024569|"     The purpose of this research study is to test the effectiveness of a standardized peer-led     intervention to teach self-management skills in improving outcomes of individuals with a     severe mental illness. The intervention is known as Wellness Recovery Action Planning or     WRAP, co-developed by Dr. Mary Ellen Copeland. The focus of the inquiry is on whether and how     developing an individualized plan for successful living: 1) lowers psychiatric symptoms; 2)     enhances psychosocial outcomes such as self-perceived recovery, empowerment, self-advocacy,     coping, and social support; 3) increases knowledge of personal mental illness self-management     strategies; and 4) enhances satisfaction with the service delivery system. The study     evaluated the following hypotheses:      Hypothesis #1: Compared to wait-list control subjects, those who participate in the WRAP     intervention will report reduced levels of psychiatric symptoms.      Hypothesis #2: Compared to wait-list control subjects, those who participate in the WRAP     intervention will report enhanced enhanced feelings of empowerment, hope, recovery, quality     of life, and functioning.      Hypothesis #3: Compared to wait-list controls, those who participate in the WRAP intervention     will report increased levels of social support.      Hypothesis #4: Compared to wait-list controls, those who participate in the WRAP intervention     will report increased use of peer services, higher satisfaction with services, and have lower     overall service costs.      Hypothesis #5: Compared to controls, those who participate in the WRAP intervention will     report increased knowledge of mental illness self-management, including making/using a WRAP     plan.      Hypothesis #6: There will be no difference in employment rates of control vs. intervention     subjects.   "
242051|NCT01024582|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided     accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount     of normal tissue that needs to be removed.      PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see     how well it works in treating patients with early-stage breast cancer.   "
242052|NCT01024595|"     The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS     P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe,     well tolerated and immunogenic. The present study is intended to extend the follow-up of the     volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and     cellular immune responses. The results of the present study will be key for the design of     future phase II trials, particularly for the definition of the optimal schedule for boosting     immunizations.      All individuals (27) will be enrolled in a 120-weeks observational study and monitored every     24 weeks for the following 3 years. During these visits, which are performed within the     schedule indicated for the clinical monitoring of HIV-1 infected individuals, in addition to     the routine virological, hematological and biochemical assessment, the anti-Tat specific     humoral and cellular immune responses will be evaluated.   "
242053|NCT01024608|"     The purpose of the study is to assess the efficacy and safety of an investigational nasal     aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.   "
242054|NCT01024621|"     The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the     biopsy number needed per patient for the detection of gastric intestinal metaplasia without     the loss of corresponding diagnostic yield.   "
242055|NCT01024634|"     The purpose of this study is to test the effects of endurance exercise training on arterial     structure and function, and to examine potential mechanisms producing changes in arterial     structure and function in young (18-35 years of age) African Americans when compared to     Caucasians.   "
242056|NCT01024647|"     The purpose of this study is to determine if increasing the dose and/or dosing frequency of     certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients     with moderate to severe Crohn's disease.   "
242061|NCT01024712|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Giving paclitaxel and carboplatin together with gefitinib may kill more     tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and     carboplatin together with gefitinib and to see how well it works in treating patients with     Stage IIIB or stage IV non-small cell lung cancer.   "
242062|NCT01024725|"     A cohort of 4000 community-dwelling adults is followed to evaluate the effectiveness of the     Finnish national A(H1N1)v influenza vaccination campaign in preventing the first episode of     laboratory-confirmed A(H1N1)v influenza. The safety of vaccination and the severity of the     disease are followed primarily from health care registers. In a subgroup of 200 participants,     the humoral and cellular immunogenicity of the vaccine will be studied.   "
242063|NCT01024738|"     Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral     rinse   "
242064|NCT01024751|"     The objective of this study is to evaluate the clinical performance of Bausch & Lomb     investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when     used by wearers of silicone hydrogel or Group IV contact lenses.   "
242065|NCT01024764|"     The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS     P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe,     well tolerated and immunogenic. The present study is intended to extend the follow-up of the     volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and     cellular immune response. The results of the present study will be key for the design of     future phase II trials, particularly for the definition of the optimal schedule for boosting     immunizations.      All individuals (20) will be enrolled in a 120-weeks observational study and monitored every     24 weeks for the following 3 years. During these visits, in addition to the hematological and     biochemical assessment, the anti-Tat specific humoral and cellular immune responses will be     evaluated.   "
242066|NCT01024777|"     The purpose of this study is to determine the safety and the immunologic effects of     supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with     multiple sclerosis.   "
242067|NCT01024790|"     The purpose of this study is to test an exercise treatment that includes behavioral     strategies to improve blood sugar control in women with type 2 diabetes who are depressed and     overweight.This research study may lead to a potentially useful treatment for diabetes     management when depression is present.   "
242068|NCT01024803|"     Patients suffering from hereditary retinal degeneration receive a retinal implant to restore     sight.      Subretinal implant ON results in significant visual acuity improvement, when compared to     OFF condition.   "
242069|NCT01024816|"     The purpose of this study is to determine whether Restorative yoga versus stretching     exercises will reduce risk factors for metabolic syndrome in adults with metabolic syndrome.   "
242070|NCT01024829|"     Increasing (boosting) the radiation dose for patients with non-small cell lung carcinoma to     the individual maximal dose which can safely be given. The question is if patients should     receive this boost on the whole tumor on part of the tumor. Therefore patients are randomized     for one of these two treatment options. All patients will receive 24 radiations. Dose     increasement will be enabled by a so called integrated boost.      Furthermore:      - PET imaging of hypoxia using [18F]HX4, single injection and then PET CT scanning two and     four hours post injection.   "
242071|NCT01024842|"     In this study, the novel vaccine candidate, MVA.HIVconsv, will be tested for safety,     tolerability and immunogenicity in HIV-1-seropositive subjects receiving effective     antiretroviral therapy.      MVA.HIVconsv will be tested as a single vaccine modality, as a prelude to testing in a     heterologous viral vector boost regimen which will include a replication-defective simian     adenovirus expressing the same immunogen.   "
242072|NCT01024855|"     A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at     specific time points over the course of four days. The study was conducted with PureVision     lenses.   "
242073|NCT01024868|"     For the purpose of assessing the spread of the local anaesthetic after injecting it between     abdominal muscles on both sides, the investigators will test if the patient can feel a change     in the perception of cold and warm, as well as being pricked with a blunt needle. The     investigators will also take several blood samples, together with routine samples, to measure     the concentration of the local anesthetic in the blood.   "
242074|NCT01024881|"     Infraclavicular approach of the subclavian veins is commonly used for central venous access.     Aberrant locations of catheter tip are frequently quoted for this approach, but few studies     have been performed to document the relationship between the shoulder position and catheter     tip location. This prospective study was performed to assess the influence of the shoulder     position on the safe and proper placement of infraclavicular subclavian catheters.   "
242075|NCT01024894|"     This study is designed to evaluate the safety of biological active dose of a new experimental     drug, IL-7, in combination with standard bi-therapy in Asiatic patients with Hepatitis C     chronic infection identified as non responders to the standard bi-therapy alone.   "
242076|NCT01024907|"     RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause     less damage to normal tissue.      PURPOSE: This phase I/II trial is studying the best way to give proton beam radiation therapy     and to see how well it works in treating patients with low grade gliomas.   "
242078|NCT01024933|"     The primary aim of this study is to evaluate whether an intervention that combines positive     affect and self-affirmation with motivational interviewing (TRIUMPH) improves blood pressure     control compared to an educational/behavioral contract intervention at 12 months. We     hypothesize that a greater proportion of participants in the experimental arm of TRIUMPH will     have adequate blood pressure control as defined by Seventh Joint National Committee on     Detection, Evaluation and Treatment of Hypertension (JNC-7.)   "
243307|NCT01040442|"     The objective of the present study was to identify the effect of direct vibration at a     frequency of 100 Hz, applied to the plantar region, on the balance of women aged 60 years or     older. The hypothesis is that the place improves body balance.   "
242079|NCT01024946|"     For patients with malignant pleural mesothelioma that has grown despite treatment with     standard chemotherapy, no treatment has yet proven beneficial. The purpose of this study is     to find out what effects, both good and bad, that everolimus has on the cancer. Everolimus     works by blocking a protein that helps the cancer grow. The goal of this clinical research     study is to learn if the study drug everolimus can shrink or slow the growth of mesothelioma.     The safety of this drug will also be studied. The patients' physical state, changes in the     size of the tumor, and laboratory findings taken during the study will help us decide if     everolimus is safe and effective.   "
242080|NCT01024959|"     The objective of this multi-center clinical study is to determine the association of the PCA3     Score with prostate biopsy outcome and validate the assay's performance characteristics in     men with previous negative prostate biopsies. An elevated PCA3 Score is thought to be     associated with an increased likelihood of positive biopsy. The results of this study are     intended to be used for regulatory filings for use as an in vitro diagnostic test.   "
242081|NCT01024972|"     Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the     brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain     arteries) is a known complication after SAH and significantly increases disability and death     after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown     that the muscles in the artery wall play a role in cVSP.      Dantrolene has been FDA approved and extensively used in clinical practice as a muscle     relaxant for more than 30 years. It has been shown to provide some benefit in animal studies     of cVSP, as well as in a small number of humans. However, the first human studies have only     been observational and over a short period of time.      This study will evaluate the safety and tolerability of intravenous dantrolene given every 6     hours over seven days to patients with or at risk for cVSP after SAH. The goal is to     determine if future efficacy studies should be done to determine if treatment with Dantrolene     may improve the outcome of patients with cVSP after SAH.   "
242082|NCT01024985|"     The purpose of this study is to determine the ability of STRATUS OCT and high resolution OCT     to detect and to quantify the neural loss in multiple sclerosis and neuromyelitis optica and     its subtypes.   "
242083|NCT01024998|"     This Phase 1 clinical research study will examine the safety and tolerability of an     experimental gene transfer agent, AAV2-sFLT01, in patients with Neovascular Age-Related     Macular Degeneration (AMD).   "
242084|NCT01025011|"     The purpose of this study is to test a new non-invasive tool to measure hemoglobin in retinal     arteries.   "
242085|NCT01025024|"     A single-nucleotide polymorphism (SNP) analysis of DNA obtained from peripheral blood of the     glaucoma patients and the normal control will be performed to find genetic marker for primary     open angle glaucoma.   "
242086|NCT01025037|"     The purpose of this study is to evaluate patient shoulder functional outcomes following     rotator cuff repairs reinforced with a surgical mesh.   "
242087|NCT01025050|"     This clinical study is an open, prospective, multi-centre eye study consisting of three study     arms to determine the safety and efficacy of intrastromal incisions for the correction of     visual acuity on presbyopic eyes. The hypothesis of the study is that by means of     intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and     effective way.   "
242088|NCT01025063|"     This study will investigate the safety and efficacy of treatment of choroidal     neovascularization (CNV) due to age-related macular degeneration (AMD) with a combination of     ranibizumab (Lucentis) and verteporfin PDT (Visudyne), as compared with ranibizumab     monotherapy.   "
242089|NCT01025076|"     Executive Summary      Aims and Hypotheses of the Study:      The aim of the study will be to evaluate the safety, effectiveness and early outcome of the     StomaphyX procedure for reducing the enlarged gastric pouch and stoma in post-bariatric     patients. The study will test a hypothesis that the StomaphyX procedure will be effective in     promoting the loss of regained weight, reducing the risk for comorbidities and improving     patients' quality of life.      Type of Study: Prospective non-randomized Study Duration: 12 months Number of Patients: 20      Inclusion Criteria:      18-70 years of age, BMI ≥ 35, ≥ 2 years after primary Roux-en-Y gastric bypass with evidence     of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or     fluoroscopy. Pts also demonstrate a weight regain of 15% of excess body weight loss.      Exclusion Criteria:      Esophageal stricture, or any anatomic conditions that preclude passage of transoral     endoluminal instruments, has another causal factor for weight regain other than stoma or     pouch dilatation, portal hypertension, coagulation disorders or chronic use of     anticoagulants, any active medical condition that would preclude the patient from completing     the study or would result in an unreasonable risk to the patient.      Intervention Treatment: Creation of multiple full-thickness plications within the gastric     pouch using the StomaphyX device (EndoGastric Solutions, Inc., Redmond, WA, USA)      Evaluation Criteria Primary Outcome: Change in body weight at 6 and 12 months Secondary     Outcome: Gastric pouch volume assessment, stoma diameter determination, quality of life     scores, waist circumference, co-morbidity resolution Effectiveness and Safety Assessment     Clinical: Weight, height, waist circumference quality of life questionnaires (Impact of     Weight QOL-Lite, Eating and Weight Patterns, Three-factor Eating, Emotional Eating Scale, GI     QoL, GSRS and/or PGWB) Anatomical: Upper GI endoscopy, computed tomography or barium     radiography Biochemical: Blood and urine tests (glucose, cholesterol, triglyceride, HDL, LDL,     uric acid) Safety: Adverse events, complications, co-morbidities, hospital stay   "
242090|NCT01025089|"     The main purpose of this study is to find out the good and the bad effects that the     combination of cetuximab with the traditional chemotherapy regimen of cisplatin, doxorubicin,     and cyclophosphamide has when given to patients with later stage thymoma or thymic carcinoma     before surgery. The physicians will also look at changes in genes in the tumor that may     relate to the effectiveness of cetuximab   "
242091|NCT01025102|"     The purpose of this study is to compare the effects and side effects of interscale block     performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.   "
242092|NCT01025115|"     The purpose of this study is to assess the efficacy of Diamel administration in the treatment     of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical     trial will be 12 months.   "
242361|NCT01020942|"     Myocyte necrosis as a result of elective percutaneous coronary intervention (PCI) occurs in     approximately one third of cases and is associated with subsequent cardiovascular events.     This study assesses the ability of electroacupuncture (EA) pretreatment to attenuate cardiac     troponin I (cTnI) release after elective PCI.   "
242298|NCT01009437|"     RATIONALE: Ritonavir may stop the growth of tumor cells by blocking some of the enzymes     needed for cancer cell growth. Studying samples of blood and tissue from patients with breast     cancer in the laboratory may help doctors learn more about the effects of ritonavir on     biomarkers involved in breast cancer growth.      PURPOSE: This phase I/II trial is studying the best dose of ritonavir and its effects on     biomarkers in women undergoing surgery for newly diagnosed breast cancer.   "
242093|NCT01025128|"     Because of its high sun exposure, Israel was traditionally supposed to be protected from     vitamin D deficiency, and the country food products hardly contain vitamin D supplements.     However the Jerusalem ultra-Orthodox population, which constitutes a significant fraction of     the city population, is at risk of developing vitamin D deficiency due to low sun exposure,     as consequence of its dressing code covering most of the body and very limited time of     outside activities. The investigators aim is to check whether vitamin D deficiency is found     more frequently in the ultra-Orthodox male population in comparison to a non-ultra-Orthodox     male population, and to study its eventual consequences. Correlation between vitamin D levels     and PTH levels will be examined, according to age and to creatinine levels. Bone mineral     density (BMD) will be evaluated in 2 selected subgroups of subjects (with lowest and highest     vitamin D levels), and re-evaluated after 6 months of vitamin D supplementation in vitamin     D-deficient subjects. An increase in BMD within 6 months would suggest osteomalacia as the     main cause of low BMD in these subjects.   "
242094|NCT01025141|"     The main objective of the investigators' study is to assess the efficacy of a course of     treatment using skeletal anchorage (MINISCREW) as compared with treatment involving dental     anchorage (reference) during dentofacial orthopedic treatment.   "
242095|NCT01025154|"     The goal of this clinical research study is to learn if the combination of clofarabine,     cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who     are between the ages of 18 and 60 years old. The safety of this study drug combination will     also be studied.   "
242096|NCT01025167|"     The purpose of the study is to determine the impact of a specific nutrition formula with a     high content of eicosapentaenoic acid (EPA) and fat in oncology patients receiving     radio-/chemotherapy on body weight, body composition, nutritional status and physical     function compared to a standard nutrition formula. Using an adaptive design approximately 80     patients will be randomized in the first part of the study. Following an interim analysis     further 160 patients may be added, for a total of 240 patients.   "
242097|NCT01025180|"     A recent study has demonstrated that in low respiratory infections, a strategy using     prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to     antibiotics by 47% without prognostic modification.      The aim is to evaluate the impact on antibiotics consumption of an algorithm using     procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly     identified hosted germs or infectious centre.      This multicenter study is a randomized prospective open study involving 9 ICU departments in     France, comparing two strategies on antibiotherapy treatment period one based on     procalcitonin level(experimental group) the other on physician's appreciation(control group)      140 adult patients should be included with a severe sepsis symptomatology, whose infectious     etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen     agent or infectious centre clearly identified.      The primary outcome is the rate of patients undergoing antibiotic treatment at D5.      Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay     in intensive care ward and evolution of the SOFA score between D0, D3 and D5.      Duration of patient enrollment is 30 days.   "
242098|NCT01025193|"     If subjects are listed for kidney transplant and are considered sensitized, this means they     have a high amount of antibodies in their blood that could react to a kidney transplant     offered for them. Antibodies are protein substances made by the body that fight anything that     the body considers as a threat to it, such as infection or a kidney transplant. Sensitization     may be due to prior transplants, pregnancy, or blood transfusions. Being sensitized can     increase the subject's kidney transplant waiting time as it is more difficult to find a     suitable kidney transplant for them that their antibodies will not react to. The purpose of     this research study is to see if giving the investigational drug belimumab up to one year     pre-transplant can de-sensitize the subjects, or decrease the amount of antibodies in their     blood. This may help make the subjects eligible to receive a kidney transplant more quickly.     If after receiving belimumab, the subjects are compatible with a donor kidney offered and are     medically suitable for transplant at that time, a kidney transplant will be performed.   "
242099|NCT01025206|"     This is a first in human study which will assess the safety and tolerability of a monoclonal     antibody against ICAM-1 in patients with Multiple Myeloma. The tumour response rate will also     be measured.   "
242100|NCT01025219|"     The purpose of this study is to assess the phenotypic candidates symptoms, in patients with     crack/cocaine addiction, in terms of clinical comorbidities, dimensions of personality, and     neuropsychological evaluations apt to be associated with genetic and genotypic     characterisations, notably on the polymorphisms of the genes coding or regulating     dopaminergic, norepinephrine and serotoninergic systems.   "
242101|NCT01025232|"     The purpose of this study is to determine whether 2.0mg Ranibizumab is effective in the     treatment of recurrent fluid.   "
242102|NCT01025245|"     The purpose of this study is to study the effect of intraoperative magnesium on     remifentanil-induced postoperative hyperalgesia after thyroidectomy   "
242103|NCT01025258|"     The purpose of this study is to assess the impact of a collaborative active intervention     program of a multi-disciplinary team on improving adherence to chronic medications and     improve clinical outcomes in CF patients.   "
242104|NCT01025271|"     This is a prospective pharmacokinetic study in patients having external ventricular drains     with suspected external ventricular drain related bacterial meningitis. A single dose of     daptomycin will be administered for the purposes of the study and PK samples will be obtained     around this dosing.   "
242105|NCT01025284|"     Part A: This study evaluates an experimental treatment in patients with extensive-disease in     small-cell lung cancer.      Part B: This study evaluates an experimental treatment in patients with extensive-disease in     small-cell lung cancer.   "
242106|NCT01025297|"     This study is designed to evaluate the safety of biological active dose of a new experimental     drug, IL-7, in combination with standard bi-therapy in patients with Hepatitis C chronic     infection identified as non responders to the standard bi-therapy alone.   "
242362|NCT01020955|"     The aim of this study is to measure effects of the combined treatment with GH and IGF-I on     glucose sensitivity and body composition in patients with GHD and IGT or diabetes.   "
242363|NCT01020968|"     This study is designed to assess the safety profile and the efficacy of cardiac repair cells     (CRCs) administered via catheter in treating patients with dilated cardiomyopathy (DCM).   "
242107|NCT01025310|"     Background and objectives: There is a general agreement that some types of urban environment     could be the source of psychological stress as opposed to natural-relaxing environment. A     number of aesthetical researches found out that the main cause for stress appearance can be     explained by the complexity and order of the environment. There are also some indications     that the stressing influence of the open environment can be measured by evaluating eye     movements, in particular saccadic movements.      The objective of this study is to characterize eye movements - mainly saccades -while     presenting visual material of different complexity and order and to evaluate the possible     relationship between eye movements and parameters of psychological and physiological stress.      Methods: The research is based on systematic gradual experiments on healthy volunteers, who     will be tested while viewing series of abstract figures and pictures of natural and urban     areas with different level of complexity and order. Each figure or picture will be showed to     subjects for 7 seconds. During the whole experimental session the investigators will measure:        1. Saccadic and other eye movements using the magnetic scleral search coil technique. The          magnetic scleral search coil technique is the most sensitive and accurate technique used          in modern ocular motor research for measuring horizontal, vertical and torsional eye          movements. The coils are easy to apply and well tolerated over a wearing period of up to          45 minutes per recording session.        2. Heart rate pulse will be measured using a commercial pulse-meter.        3. Aesthetical evaluation: Following each figure or picture 7 seconds presentation;          subjects will rate it in a scale from 1 (very relaxing) to 10 (very stressful).      Possible relationship between saccadic eye movements, heart rate and aesthetical rate will be     analyzed using WIN 11 SPSS and MATLAB in statistically accepted ways.      Population: A total of about 60 healthy subjects aged 18-60 years old will be recruited for     the study from students, faculty and staff of Tel Aviv University and of Meir Medical Center.      Criteria for inclusion: Healthy subject with normal vision      Criteria for exclusion: Eye disease such as corneal or scleral abrasion or disease, glaucoma,     refractive errors greater than 2 diopters and concurrent medication with CNS-active agents.   "
242108|NCT01025323|"     The purpose of this study is to assess the efficacy of lifestyle modification in reducing     blood pressure values in Hispanics at risk for hypertension.   "
242109|NCT01025336|"     The purpose of this study is to evaluate the levels of antibodies 1 year after receiving the     second vaccine dose in two groups of adults over the age of 60: (1) those who have previously     received 2 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) and (2) those who have     previously received 1 dose of 13vPnc and 1 dose of 23-valent pneumococcal polysaccharide     vaccine (23vPS). This study will also assess whether the use of the 2 vaccines, 13vPnC and     23vPS, administered in different sequential order results in different prolonged antibody     levels. This study is limited to individuals who participated in either study 6115A1-3010     (NCT00574548) or 6115A1-3005 (NCT00546572).   "
242110|NCT01025349|"     Bevacizumab is a monoclonal antibody currently used for the treatment of colorectal cancer.     It works by preventing the formation of new blood vessels (angiogenesis). The drug has been     shown to inhibit vascular endothelial growth factor (VEGF) activity. Previous research showed     positive findings in other solid tumors that had metastasized. In this study, the     investigators are investigating the response of adding bevacizumab to conventional     chemotherapy for metastatic breast cancer patients.   "
242111|NCT01025362|"     The Norwegian Action Plan on Nutrition aim at increasing the prevalence of breastfeeding. The     initiative Baby-Friendly Community Health Services (BFCHS) is an initiative to reach this     goal. BFCHS is developed from the concept The Baby-Friendly Hospital Initiative by     WHO/UNICEF, and the intention is to increase the quality of breastfeeding counseling at     Norwegian well-baby clinics.      The purpose of the study      The study seeks to answer the following research questions:        -  What effect does the process of being certified as a BFCHS have on the proportion of          mothers who exclusively breastfeed their children for 5 months?        -  What effect does the process of being certified as a BFCHS have on the proportion of          mothers who exclusively breastfeed for 4 months?        -  What effect does the certification process have on the proportion of mothers who          breastfeed at 11 months of age?        -  What effect does the certification process have on the differences in breastfeeding due          to social inequality?        -  What effect does the certification process have on the mothers impression of the quality          of the well-baby clinics lactation counseling?        -  What effect does the certification process have on mothers satisfaction with the          breastfeeding experience?        -  What effect does the certification process have on perceived pressure to breastfeed?          Methods Cluster randomized controlled study Sampling The survey unit, cluster, will be          the community health services. All community health services in six counties in Norway          will be invited to participate.      Inclusion criteria: Norwegian speaking mothers who have 5 month and 11 month old children.      Data collection Respondents are identified through the National Population Register (DSF).     The data collection takes place using a postal questionnaire.      Baseline: Data collection before the intervention is implemented to assess breastfeeding     prevalence and distribution of covariates in the two study arms.      Post-survey: The post-survey to assess the effect, will take place about two years after     baseline when the community health services have been certified.      Sample size It is expected that the project could increase the breastfeeding prevalence with     5 percentage points. This assumption is the basis for the sample size. The initial aim is to     recruit about 50 well-baby clinics.   "
242112|NCT01025375|"     To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.   "
242113|NCT01025388|"     The purpose of the study is to establish the proportion of patients on lipid-lowering     pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004     NCEP ATP III guidelines, overall and by country, in the following sub-populations:        -  Primary/secondary prevention patients.        -  Patients with metabolic syndrome (according to NCEP III definition).      In addition, the purpose is to establish the proportion of patients on lipid-lowering     pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task     Force guidelines/national guidelines, in the survey population and in the following     sub-populations:        -  Primary/secondary prevention patients.        -  Patients with metabolic syndrome.   "
242114|NCT01025401|"     CAPAMETRIM 2 aims to characterize epileptic motor patterns by a quantitative     three-dimensional analysis of movements.      This is done to obtain a 3-D motor signature of seizures, for a given patient, and allows     their detection with an ambulatory monitoring system.      The benefit for patients is to improve the diagnosis of their diseases by better     characterizing their seizures.   "
242115|NCT01025414|"     The primary objective of this study is to evaluate the effectives of enteral nutrition in the     treatment of pancreatic fistulas. The ratio of pancreatic fistula closure after 30 days is     selected as the primary outcome measure with the null hypothesis assuming that enteral     nutrition provides better results than parenteral nutrition as far as the closure ratio, time     to closure and treatment-related complications are concerned.   "
242126|NCT01025557|"     The purpose of this protocol is to study the effects of fluid milk products on satiety, food     intake, and glucose metabolism in healthy young men and women. Experiment 1: The specific     objective is to investigate isovolumetric amounts of milk (2% M.F.), chocolate milk (1%     M.F.), a soy beverage, cow's milk-based infant formula, and water (control) on satiety and     food intake and on blood glucose before and after a meal. A fixed volume approach is based on     the commercially available serving size. Experiment 2 will examine equicaloric amounts of     milk (2% M.F.), chocolate milk (1% M.F.), a soy beverage, cow's milk-based infant formula, a     glucose drink and water (control) the treatments in order to investigate macronutrient     composition on satiety and food intake and on blood glucose before and after the meal.   "
242127|NCT01025570|"     The purpose of this study is to find out the effects, good and/or bad, of the combination of     two drugs, gemcitabine and bosutinib, in patients with resected pancreatic cancer and whether     this combination can prevent pancreatic cancer from coming back.   "
242374|NCT01021111|"     The overall goal of this project is to reduce the risk for anterior cruciate ligament     injuries by designing a targeted intervention that will alter the known kinematic and kinetic     risk factors associated with ACL injuries.   "
242116|NCT01025427|"     Although highly active antiretroviral therapy (HAART) decreases HIV-associated mortality, it     does not to completely restore health. Patients doing well on otherwise effective HAART     remain at risk for cancer, cardiovascular/liver disease, osteopenia, and other     non-AIDS-defining events. While complete eradication may never be feasible, a functional     cure in which patients are able to maintain undetectable viral loads indefinitely without     therapy may be possible. The best evidence for this are the so-called elite controllers,     whom we define as individuals who are HIV-seropositive, with plasma HIV RNA levels below the     level of conventional detection without treatment. Controllers may be conceptualized as a     naturally occurring model of a functional cure (or HIV remission), and are ideal patients     in which to study HIV persistence and the possibility of eradication.      We propose to conduct a pilot study to better characterize the reservoirs that lead to viral     persistence in a group of well-characterized controllers. We propose two specific aims: 1) to     characterize the dynamics of viral production in blood and gut-associated lymphoid tissue     (GALT) in controllers; and 2) to prospectively treat 10 controllers with raltegravir,     tenofovir/emtricitabine for 24 weeks and study the effects of HAART on viral dynamics and     host inflammatory responses.      Our primary hypotheses are: 1) viral replication is ongoing in untreated controllers, 2)     HAART will reduce viral replication in blood and GALT and decrease immune activation, and 3)     higher levels of immune activation are associated with greater measures of microbial     translocation and distribution of virus to more differentiated T cell subsets.   "
242117|NCT01025440|"     Phase One:      High Flow (HF) CPAP (HF-CPAP) Titration:      Participants will attend the sleep lab to undergo a comprehensive split-night respiratory     PSG. Each participant will be randomized to one of 20 L/min or 35 L/min of CPAP for the first     half of the night and swapped to the alternate flow rate for the second half o the night.      At the completion of night 3 participants will be categorized as responders or     non-responders. Only responders will continue to Phase 2 of the investigation.      Phase Two:      HF-CPAP compared with CPAP:      Participants will attend the sleep lab to undergo a comprehensive overnight respiratory PSG.     Each participant will be randomized to HF-CPAP at a flow rate of 35 L/min or to conventional     CPAP at their therapeutic pressure. They will spend the entire night on this treatment arm.     Thew following night participants will undergo the alternative treatment arm for the duration     of the night.   "
242118|NCT01025453|"     The purpose of this study is to find out what effects, good and/or bad, the combination of     sorafenib and temsirolimus will have on thyroid cancer. Treatment guidelines from the     National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid     cancer.      Temsirolimus is an intravenous medication that is FDA approved for other type of cancers. In     laboratory studies, the addition of temsirolimus to sorafenib works better than sorafenib     alone.   "
242119|NCT01025466|"     The primary objective is to compare the tolerability between rivastigmine patch monotherapy     and combination therapy with memantine in patients with Alzheimer's disease (AD). The     secondary objective is to compare the efficacy and safety between rivastigmine patch     monotherapy and combination therapy with memantine in patients with AD. The study hypothesis     is that the tolerability of the combination therapy with memantine is not inferior to that of     rivastigmine patch monotherapy in AD patients.   "
242120|NCT01025479|"     Prevalence rate of osteoporosis and it's actual management condition in Prostate cancer     patients who takes LHRH antagonist and anti androgen   "
242121|NCT01025492|"     Fibrates reduce atherosclerosis and cardiovascular disease events. A major mechanism of this     benefit appears to be their ability to raise plasma high density lipoprotein cholesterol     (HDL-C), especially in patients with high triglyceride levels. This study will investigate     the effects of the addition of Trilipix (fenofibric acid) versus placebo to ongoing statin     treatment on high density lipoprotein (HDL) composition and arterial function in subjects     with insulin resistance.   "
242122|NCT01025505|"     This study is an open-label, multicentric, exploratory, single arm, phase II study of adults     who are either more than 60 years old, or are unfit for intensive chemotherapy and allo SCT.     The patients are treated with NILOTINIB, administered orally twice daily, for 6 weeks (Course     A) followed by IMATINIB, administered orally twice daily, for other 6 weeks (Course B).The     courses will be repeated (rotated) for a total of 4 times or until relapse, or until it is in     the interest of the patients. Prednisone (P) will be administered to all patients for 7-14     days, before TKIs, so as to make it possible to wait for the results of cytogenetic and     molecular tests, and to evaluate the response to P alone, hence for another 21 days.     Intrathecal therapy (IT) with MTX/AraC/DEX is mandatory, monthly, in patients without     clinical-cytologic evidence of meningeal involvement, while in patients with CNS involvement     it is performed twice weekly until clearance of leukemic cells, hence once weekly. IM will be     administered at the dosage of 600 mg daily (300 mg twice daily) and Nilotinib at the dosage     of 800 mg daily (400 mg twice daily) in all courses.      All patients are scheduled to receive at least 4 courses of either drugs, for a total of 4     courses (4 x 6 = 24 weeks). After 4 courses, patients are either allowed to continue the     treatment until relapse or progression, if it is in their interest, or to discontinue the     treatment and receive other therapies.   "
242123|NCT01025518|"     The purpose of this study is to investigate whether resistance training in combination with     dietary supplementation is tolerable among head and neck cancer patients and to evaluate the     possible effect on muscle mass, strength and functional capacity.   "
242124|NCT01025531|"     Subjects who eventually undergo treatment for HCV, we will gather treatment data (start and     stop dates), and repeat CB-CAP analysis at weeks 4, 12, 24 and 72 (+/- 2 week window allowed     at each time point) to determine whether CB-CAPs levels predict virologic response in treated     subjects. Routine laboratory data will also be collected at these time points.   "
242125|NCT01025544|"     This study will evaluate the safety and immunogenicity of booster doses of the two vaccines     used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.   "
242128|NCT01025583|"     Hypotonic oral rehydration solutions (ORS) containing zinc and/or prebiotics have been     proposed for the treatment of pediatric acute diarrhea but conclusive clinical data about     their effect are scanty, especially for children living in developed countries. The     investigators aim to evaluate the efficacy of a new hypotonic ORS containing zinc and     prebiotics in children with acute diarrhea.   "
242130|NCT01025609|"     This study will look at dietary patterns in individuals with chronic spinal cord injuries and     the relationship between these dietary patterns and cardiovascular disease risk factors. The     study is a supplement to the Coronary Artery Risk Development in Young Adults (CARDIA) study.     The dietary history from CARDIA will be used. The investigators' primary hypothesis is the     following: Greater whole-grain and dietary fiber intake will be favorably associated with     adiposity (BMI and WC) and metabolic CVD risk factors (fasting glucose, fasting insulin,     HOMA-IR, diabetes, hsCRP, TC, HDL-C, triglycerides, TC/HDL-C ratio, non-HDL-C, and systolic     and diastolic blood-pressure) among a sample of individuals with SCI aged 38-50 who have been     injured >1 year.   "
242131|NCT01025622|"     OBJECTIVE(S): Primary:      To assess the safety of the intrahepatic reinfusion of increasing numbers of autologous     highly purified CD133+ stem cells (SCs) to patients with end-stage liver disease. Safety will     be evaluated as the incidence of adverse event (graded according to WHO) and clinically     significant abnormal laboratory value following reinfusion of SCs.      Secondary:      To assess the feasibility of the immunomagnetic selection of autologous CD133+ cells     collected with leukapheresis from the peripheral blood (PB) of patients with end-stage liver     disease, previously mobilized with G-CSF. To assess the effects of the intrahepatic     reinfusion of highly purified CD133+ cells on residual hepatic function of the patients.      STUDY DESIGN:      Twelve patients will be enrolled. At first, G-CSF at 7.5µg/Kg/b.i.d. will be administered     subcutaneously (sc) from day 1 until the completion of peripheral blood stem cells (PBSC)     collection. Harvest of bone marrow (BM)-derived PBSC will begin on day + 4 only if the     concentration of CD133+ cells is > 8/uL and will be continued until the collection of the     target cell dose: 0.5 x 106 CD133+ cells/Kg for the first 2 cohorts of patients; 1 x 106     CD133+ cells/Kg for cohort 3 and 2 x 106 CD133+ cells/Kg for cohort 4 (see below for     definitions). PB mononuclear cells obtained from mobilized standard-volume leukapheresis will     be incubated with Macs colloidal superparamagnetic CD133 microbeads and CliniMacs device will     be used for the positive selection of CD133+ cells under good manufacturing practice (GMP)     conditions. Cryopreservation and storage in liquid nitrogen will be performed according to     standard procedures. At least 4 weeks after SC mobilization and collection, up to 40 mL of     single cell suspension of highly purified autologous CD133+ cells, obtained after rapid     thawing, will be infused through the hepatic artery by transfemoral or transbrachial     arteriography. Infusion time will be lower than 15ml/min to avoid thrombi formation. The     entire procedure will be performed under anesthesiological control. According to modified     Fibonacci's increment rule, highly purified G-CSF-mobilized CD133+ cells will be administered     to patients starting from 5x104/Kg patient's body weight and increased every 3 patients. The     maximum infused cell dose will be 1x106/kg. G-CSF at 5µg/Kg/day will be administered sc for 3     days after the reinfusion of SCs (day 0 to day +2).   "
242132|NCT01025635|"     This study will investigate the safety and efficacy of a new formulation of an existing     medication for the treatment of papulopustular rosacea. The study will test the active     ingredient plus foam against foam alone.   "
242133|NCT01025648|"     The main objective of this study is to evaluate the efficacy and safety of the Armstrong's     Epinephrine HFA-MDI (E004) formulation, in comparison to the Placebo (Placebo-HFA) and an     Active Control (Epinephrine CFC-MDI), and to identify the optimum E004 dose strength(s) for     the ensuing pivotal clinical trials. The study will be conducted in adult patients who have     intermittent, or mild-to-moderate persistent, asthma, but are otherwise healthy.      The bronchodilatory efficacy of E004, is evaluated in terms of post-dose area under the     curves (AUC) of FEV1 changes (% and volumes), from the pre-dose baseline values, in     comparison to the Placebo Control and the Active Control.   "
242134|NCT01025661|"     The purpose of the study is to explore the short term effects of chiropractic care on pain     and function in patients with hip osteoarthritis.   "
242135|NCT01025674|"     This project focuses on social and character development of elementary and middle school-aged     children and responds to an urgent national need that schools improve their capacity to     address a range of student outcomes, including social skills, character, behavior, academic     achievement and health outcomes. This study is a school-based randomized trial to evaluate     the Positive Action program. The Positive Action program was designed to promote social and     character development and improve behavior and school performance.   "
242136|NCT01025687|"     The investigators hypothesize that television viewing will affect food intake in adolescent     girls, and will depend on pubertal stage. Food intake will be measured at 30 min following a     glucose(1 g of glucose/kg body weight) or sweetened noncaloric beverage with or without the     presence of TV. Subjective appetite will be measured as well.   "
242137|NCT01025700|"     Safety of Nabilone in reducing marijuana craving   "
242138|NCT01025713|"     The purpose of this study is to evaluate the safety and tolerability of GS-9411 in patients     with Cystic Fibrosis. GS-9411 is a sodium channel inhibitor, that may restore airway     hydration and mucociliary clearance in the lung.   "
242139|NCT01025726|"     Regular moderate and vigorous intensity physical activity (PA) is inversely related with     obesity, however, few adults are successful in incorporating sufficient PA into their daily     lives. Minority and lower-income adults have among the highest obesity rates and lowest     levels of regular PA. Increasing environmental supports for safe and convenient places for PA     is an emerging public health strategy for PA interventions. Preliminary data by Wilson (PI)     and colleagues has revealed through focus groups that low-income minority adults would like     to increase the safe places for PA (areas free from crime, containment of stray dogs,     increased police patrol) and access to PA (sidewalks/trails and expand opportunities for PA)     in their community. In addition, the results of the investigators' preliminary studies     suggest that African Americans had psychosocial barriers to PA that included lack of     self-motivation, cultural body image issues, and lack of time due to family obligations. The     present proposal is innovative in that it specifically tests the efficacy of an intervention     that includes both patrolled-walking and social marketing elements to increase PA in     low-income African Americans. Three communities will be randomized to receive one of three     programs: a police patrolled-walking program plus social marketing intervention, a police     patrolled-walking only intervention, or no walking intervention (general health education     only; N=390; 130/group). The 24-month intervention will focus on increasing safety (training     community leaders to serve as walking captains, hiring off-duty police officers to patrol the     walking program, and containing stray dogs), increasing access for PA (marking a walking     route), and will include a tailored social marketing campaign for increasing PA (in one     intervention community). The investigators will collect data for PA (7-day accelerometer     estimates, 4-week PA history), body composition, blood pressure, psychosocial measures, and     perceptions of environmental supports for safety and access for PA at baseline, 6-,12-,18-,     and 24-months. The primary hypotheses are that the patrolled-walking plus social marketing     intervention will result in greater increases in moderate and vigorous PA as compared to a     patrolled walking only intervention or no-intervention by 12-months and that these effects     will be maintained at 18-month and 24-month assessments.   "
242149|NCT01025856|"     The aim of this study will be to evaluate in patients with type 2 diabetes the effects on     liver fat of an intervention with a diet relatively rich in CHO/rich in fibre/low GI or a     diet rich in MUFA, either combined or not with a structured program of physical exercise,     with emphasis on mechanisms possibly underlining these effects, namely changes in     postprandial triglyceride-rich lipoproteins, body fat distribution, insulin sensitivity,     oxidative stress and inflammation, adipose tissue lipolytic activities, aerobic capacity and     endothelial function.   "
242150|NCT01025869|"     To investigate the safety and efficacy of the Cinatra™ Corolimus Drug Eluting Stent for the     treatment of de novo lesions in native coronary arteries.   "
242407|NCT01027208|"     To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer     who have completed the previous Phase II study (CA163-107)   "
242140|NCT01025739|"     Objectives of the Study:      The primary objective of this study is to evaluate the relative merits, safety and     effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent     GERD symptoms despite PPI therapy.      The secondary objective of the study is to evaluate the effectiveness of the tailored TIF     procedure in restoring the antireflux barrier and eliminating GE reflux.      Type of Study:      Prospective, non-randomized, uncontrolled Study Duration 12 months Number of Patients 20      Inclusion Criteria:      Age 18-70 years, on daily PPIs for > 6 months, persistent GERD symptoms despite PPI therapy,     anatomic disruption of the gastroesophageal valve to a Hill Grade II-III, evidence of one of     the following while on PPI therapy: (1) erosive esophagitis (erosions or ulcerations during     endoscopy); (2) abnormal ambulatory pH study; or (3) biopsy confirmed changes characteristic     of reflux esophagitis; acceptable esophageal motility (by either manometry or video     esophagogram), hiatal hernia no larger than 2 cm, patient willing to cooperate with     post-operative dietary recommendations and assessment tests, signed informed consent      Exclusion Criteria:      BMI > 40, hiatal hernia > 2 cm, esophagitis grade D, esophageal ulcer, fixed esophageal     stricture, gastric motility disorders, previous splenectomy, pregnancy (female),     immunosuppression, ASA > 2, portal hypertension and/or varices, history of previous resective     gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal     epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis,     or cirrhosis, active gastro-duodenal ulcer disease, gastric outlet obstruction or stenosis,     gastroparesis or delayed gastric emptying, coagulation disorders      Interventions:      Treatment: Tailored transoral incisionless fundoplication (TIF2) using EsophyX system with     SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA)      Evaluation Criteria:      Primary Outcome Measure 24 hour pH impedance study: change in Johnson DeMeester scores;     GERD-HRQOL scores Secondary Outcome Measures PPI usage, GERD symptoms at 6 and 12 months vs.     baseline off PPI's, total number of reflux episodes, and Symptom Association Probability     while off PPI.      Safety: Adverse events will be mapped to standard terms and reported.   "
242141|NCT01025752|"     The proposed study will test how well an innovative method, interactive voice response (IVR),     can be used for delivering an treatment for chronic low back pain. The use of IVR will     improve the accessibility of treatment to Veterans. IVR is a computerized interface that     allows patients to use their telephone to: 1) obtain pre-recorded didactic information, 2)     report data regarding pain-related symptoms and adherence to pain coping skill practice, and     3) receive personalized therapist feedback. Although CBT has been shown to be effective in     reducing pain intensity, traditional CBT requires patients to make frequent office visits.     The use of IVR will allow Veterans to access CBT from their home via a touch-tone telephone,     thereby allowing them to access treatment at their convenience without travel to the VA for     an outpatient appointment. Veterans with chronic low back pain will be randomized in equal     numbers to receive either standard CBT or IVR-based CBT. Veterans in both conditions will     receive 10 session of treatment designed to help them manage their chronic pain using pain     coping skills. The primary outcome measure will be pain intensity.   "
242142|NCT01025765|"     Pegylated interferon in combination with ribavirin is the current standard treatment of     chronic hepatitis C virus infection, but is expensive and has several adverse effects. To     modify this standard treatment by optimizing its therapeutic effect and decreasing its     adverse events are important. Recent studies have identified a close link between metabolic     profiles, insulin resistance and Hepatitis C Virus (HCV) infection. Several pilot studies in     western world have have found beneficial effects of oral hypoglycemic agents on chronic     Hepatitis C (CHC) genotype 1 infected patients. Whether this concept still holds true in     Taiwanese people remains unknown.      The objective of this clinical trial is to evaluate the effect of oral hypoglycemic agents     (daily for 4 weeks of run-in period and 8 weeks of combination treatment) on CHC genotype 1     infected Taiwanese patients receiving 48 weeks of Peg-IFN plus ribavirin (RBA), and the     enrolled subjects will be randomized into 4 treatment groups (including Acarbose, Metformin,     Pioglitazone and standard care control groups). During the trial and 24 weeks after the end     of treatment, serial serum HCV RNA, alanine aminotransferase (ALT) levels, and other clinical     data will be evaluated to determine the therapeutic response and adverse events of the CHC     patients.   "
242143|NCT01025778|"     Despite substantial progress in the treatment pediatric acute leukemia a significant number     of children will experience primary or secondary resistance to the treatment. In other words     it will be not possible to achieve remission using standard chemotherapy (primary resistance)     or the patients will develop chemotherapy resistant relapse (secondary resistance). Children     failing to achieve remission or children relapsing after previous allogeneic stem cell     transplantation have short life expectancy and palliative treatment still remains the most     reasonable option as the escalation of conventional chemotherapy is not longer effective.      The role of Graft versus Leukemia effect was postulated as one of the mechanisms contributing     to the leukemia control/eradication after transplantation of hematopoietic stem cells.      In this study the investigators combine intensified multiagent Clofarabine containing     chemotherapy with post-induction treatment intensification using reduced intensity     conditioning followed by haploidentical hematopoietic stem cell transplantation. Introducing     a new drug to the treatment of resistant leukemia the investigators want to achieve a     response which allows us to proceed to immediate haploidentical transplantation. Using a     haploidentical donor the investigators can avoid time consuming search for an unrelated donor     and perform the transplantation at the optimal time-point. Combating therapy resistant     leukemia the investigators would like to evoke and utilize potential Graft-versus-Leukemia     effect which is much more pronounced in the haploidentical setting, as it is well documented     that allogeneic transplantation with a matched donor is not effective in resistant disease.     The use of best KIR mismatch donor and post-transplant donor lymphocyte infusion will be     implemented in order to develop/intensify graft versus leukemia effect.   "
242144|NCT01025791|"     A three panel study, to determine if MK8266 given as a single dose is sufficiently safe and     well tolerated. Panel A and B will consist of healthy young males and Panel C will consist of     subjects with mild to moderate hypertension.   "
242145|NCT01025804|"     Asparaginase is an important drug in the treatment of childhood leukemia including in infant     (<1 year). The prognosis for infants is bad.      Information about drug metabolism in neonates and infants is scarce as well as the reactions     of an immature immune system to foreign proteins. The aims of this study is to describe the     metabolism (pharmacokinetics) of asparaginase after administration intramuscularly and to     evaluate the formation of antibodies against the drug (enzyme) during treatment in order to     optimize the asparaginase treatment in infants in the future.   "
242146|NCT01025817|"     The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with     low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney     transplant recipients.   "
242147|NCT01025830|"     The null hypothesis is that there is a difference in the the relative rate and extent of     absorption into the systemic circulation of Triomune and brand-name     Stavudine/Lamivudine/Nevirapine in HIV-infected Africans and the alternative hypothesis is     that there is no difference in the the relative rate and extent of absorption into the     systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in     HIV-infected Africans. This is a non-inferiority study.   "
242148|NCT01025843|"     This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety,     tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males.     Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in     participants with hypertension. The primary hypothesis is that single oral doses of MK-5478     are sufficiently safe and well tolerated.   "
242151|NCT01025882|"     RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the     tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving stereotactic body radiation therapy     together with gemcitabine hydrochloride may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects of stereotactic body radiation     therapy when given with or without gemcitabine hydrochloride in treating patients with     pancreatic cancer that can be removed by surgery.   "
242152|NCT01025895|"     ACL tear is a common injury among athletes. The recommended treatment includes reconstruction     of the ligament. The common reconstruction technique is single bundle reconstruction.     However, this technique does not simulate the natural structure of the ligament. The purpose     of the study is to compare between the common procedure, Single Bundle reconstruction with     the Double Bundle reconstruction technique.   "
242153|NCT01025908|"     The objective of this study in cognitive-behavioural therapy (CBT) was to demonstrate the     preparation of the patient with panic disorder for agoraphobic exposures. The focus of the     work consisted of interoceptive exposures, in vivo, of body sensations themselves, to feared     places and situations. The sample consisted of 50 individuals. Group 1 undertook 10 weekly,     individual sessions of CBT of one hour duration. Group 2, control, was just follow-up with     supportive therapy. The procedures used for the exposures, especially for induction symptom     exercises, were considered essential in the preparation of patients with panic disorder, to     be able to face up to panic attacks and subsequent agoraphobic situations.   "
242154|NCT01025921|"     We aim to study whether the use of inhaled antibiotics may have an impact on the incidence of     tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The     investigators hypothesize that this could be possible by decreasing the population of gram     negative germs that colonize the lumen of tracheal tube and upper airways.   "
242155|NCT01025934|"     The purpose of this study is to evaluate the role, the safety and the effectiveness of     Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe     proliferative diabetic retinopathy.   "
242156|NCT01025947|"     STUDY TYPE:      Prospective, national , multicenter, and observational study.      OBJECTIVE:      To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF     detection device during a period of 2 years.      DEVICE:      Reveal XT 9529 (SQDM)      SAMPLE SIZE AND STUDY DURATION:      100 patients enrolled which will be followed during a period of 2 years.   "
242157|NCT01025960|"     Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer     deaths in western countries. Colonoscopy is a preferred colorectal screening modality since     it has both diagnostic and therapeutic capability. Detection and removal of polyps at     colonoscopy decreases the incidence and mortality from colorectal cancer.      Typical practice is to insert the colonoscope rapidly until it reaches the cecum (a     pouch-like portion of the intestines, where the large bowel and the small bowel meet). The     physician then withdraws the colonoscope slowly and looks for any polyps or abnormalities     within the large bowel. The purpose of this study is to compare this standard practice to the     approach whereby the physician examines the bowel as the scope is initially inserted AND as     the colonoscope is withdrawn from patients' colons.   "
242158|NCT01025973|"     The investigators will perform biochemical and metabolic evaluations on cord blood, venous     blood of the mother and urine of the foetus and mother using time-of-flight and tandem mass     spectrometry. The investigators could evaluate, dose and validate gestational diabetes     mellitus biomarkers of the fetus and mother.   "
242159|NCT01025986|"     The purpose of this study is to conduct a prospective analysis to determine the relationship     between disease activity of noninfectious uveitis and stress.   "
242160|NCT01025999|"     This study is designed as a prospective clinical trial aimed at investigating the mechanisms     behind observed improvements in type 2 diabetes mellitus (T2DM) following bariatric surgery.     The majority of patients with T2DM who are undergoing Roux-en-Y gastric bypass (RYGB)     surgery, in particular, experience complete remission of T2DM almost immediately     post-surgery. This response occurs before significant weight loss is possible. To assess the     mechanisms involved with disease resolution, the investigators propose a study to evaluate     patients at the UW Medical Center (UWMC) who have T2DM and are undergoing RYGB with G     (gastronomy)-tube placement as part of their clinical care. The investigators are interested     in this sub-population as the G-tube allows us the unique opportunity to evaluate glycemic     control and insulin response following delivery or exclusion of nutrients to the otherwise     bypassed portion of the gastrointestinal tract. The investigators hypothesize that nutrient     delivery to the proximal GI tract will reverse RYGB-mediated improvements in glucose     homeostasis, possibly in association with changes in nutrient-regulated gut peptides involved     in glucose control.   "
242161|NCT01026012|"     It is been known for at least 20 years that the hemodynamic data, the amount of exercise     performed as well as symptoms on the treadmill, has significant value to the perfusion stress     testing. When a pharmacologic stress test is performed (and adenosine stress test over 4-6     minutes), this hemodynamic data is lost. Because of this loss of valuable data, it is felt     that there is also a loss of significant prognostic data as well. With the advent and FDA     release of Regadenoson in a rapid injection form (over 10 seconds), it is thought that the     combination of both exercise stress testing and pharmacologic testing in subjects that do not     achieve 85% in a maximal predicted heart rate may be a viable stress testing option.      The purpose of this study is to look at using the drug, regadenoson, with exercise stress     testing; and the side effect symptoms that may be experienced by individual subjects using     this combination.   "
242162|NCT01026025|"     The objectives of this clinical trial are to estimate the incidence and duration of air leaks     and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic     Surgery) when using the ENDO GIA Staplers with ENDO GIA Single Use Loading Units (SULUs)     buttressed with Duet TRS TM in an anatomic pulmonary resection via Video Assisted     Thoracoscopic Surgery (VATS). Anatomic pulmonary resection is defined as either a lobectomy     or segmental resection. Results of the study will be compared to contemporary literature for     a similar population.   "
242408|NCT01027221|"     Principal purpose of the study is the determination of an active local external beam     radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.   "
242163|NCT01026038|"     This is an open-label study (a study in which the doctors and participants know which drug or     vaccine is being administered) in children who previously received a 4-dose series of a     pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In     this study, participants will receive an additional dose of 13-valent pneumococcal conjugate     vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody     response by measuring any remaining pneumococcal antibodies since the previous study. This     study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate     vaccine when administered at least 24 months after the last dose of pneumococcal conjugate     vaccine.   "
242164|NCT01026051|"     The clinical trial is evaluating a multi-component active immunotherapy designed to stimulate     an immune reaction to specific tumor associated antigens which are highly expressed on     melanoma   "
242165|NCT01026064|"     The purpose of this study is to investigate the utility of the cantharidin-induced skin     blister assay for evaluation of the anti-inflammatory effects of macrolides in healthy male     volunteers.   "
242166|NCT01026077|"     The Savella Pregnancy Registry is a US based registry designed to monitor pregnancies exposed     to Savella (milnacipran HCI). This is an observational, exposure-registration and follow-up     registry designed primarily to estimate the prevalence of major congenital anomalies, and     secondarily to estimate the prevalence of recognized spontaneous abortions, stillbirths,     induced abortions, minor congenital anomalies, and any serious adverse pregnancy outcomes     among pregnancies exposed to Savella as well as adverse outcomes observed during the first     year of life in off-springs born from these exposed pregnancies. Live offspring are followed     from birth until age one. The Savella Pregnancy Registry is sponsored by Allergan (formerly     Actavis PLC and Forest Laboratories Inc.) and managed by INC Research, LLC.   "
242167|NCT01026090|"     Primary Objective:      To determine whether daily administration of dronedarone started 5-7 days before     cardioversion is superior to dronedarone started only after cardioversion with respect to the     absence of symptomatic, ECG confirmed, atrial fibrillation (AF) recurrence over 6 months in     adult patients with persistent AF, for whom cardioversion is clinically indicated and planned     to reduce symptoms and antiarrhythmic treatment is clinically indicated to reduce the risk of     cardiovascular hospitalization due to AF.      Secondary Objectives:      Main Secondary :        -  To assess the number of symptomatic AF recurrences/patient/6 months with and without ECG          confirmation;        -  To assess characteristics of symptomatic AF recurrence in the two treatment arms          (frequency, duration of episodes, type, number, and severity of AF symptoms per          patient);        -  To compare the rates of early recurrences of AF between the two treatment strategies;      Other secondary:        -  To assess whether there is a difference in proportion of patients with symptomatic AF          recurrences (with and without ECG confirmation) between the two treatment strategies;        -  To assess whether there is a difference in number of electrical cardioversions per          patient between the two treatment strategies;        -  To assess the impact of the two strategies on number of shocks, cumulative amount of          energy delivered, shock failure, and immediate success of cardioversion;        -  To assess whether there is a difference in rate of cardiovascular (CV) hospitalizations          and length of hospital stay between the two treatment strategies;        -  To assess whether there is a difference in quality of life between the two treatment          strategies.   "
242168|NCT01026103|"     The objectives of this clinical trial are to assess in a pilot setting the overall     performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™     Technology when used in a gastric bypass procedure.   "
242169|NCT01026116|"     Manifold data revealed that young breast cancer patients are characterized by aggressive     clinical history. The purpose of this study is to evaluate the efficacy and safety of     different strategies incorporating paclitaxel to anthracycline-based regimens in young breast     cancer patients.   "
242170|NCT01026129|"     This study is designed to compare the effects of a bolus dose of remifentanil to a bolus dose     of lidocaine given prior to the emergence of anesthesia:        -  on the incidence of perioperative coughing        -  on the time needed for the emergence of a desflurane-based anesthesia        -  on the incidence of sore throat after extubation.      Our hypothesis is that the use of a remifentanil bolus dose given prior to emergence of a     desflurane-based anesthesia will reduce the incidence of perioperative coughing from 70% to     35% compared to lidocaine.   "
242171|NCT01026142|"     This randomized, two-arm study evaluated the efficacy and safety of a combination of     trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal     growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population     consisted of female patients, whose disease had progressed during or following previous     trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received     trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and     capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and     1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg     iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued     until disease progression or unacceptable toxicity.   "
242172|NCT01026155|"     Obese patients are known to have increased work of breathing inducing dyspnea, exercise     intolerance and impaired quality of life. Respiratory muscle training is known to increase     respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy     subjects and respiratory patients. The investigators hypothesized that Respiratory muscle     training would reduce dyspnoea, increase exercise tolerance and quality of life in obese     patients.   "
242173|NCT01026181|"     This is a prospective case series study; all morbidly obese patients that need surgical     management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic     Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic     gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The     outcome measures will be percentage of excess weight loss, BMI, operative time, hospital     stays, complications and improvement of comorbidities.   "
242174|NCT01026194|"     The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in     combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12     weeks administration and to evaluate the safety and efficacy of MP-513 in combination with     thiazolidinedione with an extension treatment for up to 52 weeks.   "
242175|NCT01026207|"     Introduction:      The prevalence of overlap between Chronic Obstructive Pulmonary Disease (COPD) and     Obstructive Sleep Apnea Syndrome (OSAS) is around 10%. This overlap syndrome is an important     issue because is related to nocturnal desaturation and its complications. The use of portable     monitoring devices (PM) for the diagnosis of OSAS was recently accepted as an alternative to     full-night polysomnography (PSG). However, there are not studies evaluating the PM recording     in COPD patients to detect or exclude OSAS.      Objective:      To evaluate if a PM (Stardust®, Respironics, Inc, USA) could accurately measure the     apnea-hypopnea index (AHI) in COPD patients with a suspicion of OSAS.   "
242176|NCT01026220|"     This phase III trial is studying how well giving combination chemotherapy together with     radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma.     Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either     by killing the cells or by stopping them from dividing. Radiation therapy uses high energy     x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy     may kill more cancer cells.   "
242177|NCT01026233|"     The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in     patients with CD30-positive cancers. The study will assess electrical activity of the heart     before and after brentuximab vedotin administration. Patients who have stable or improving     disease may receive up to 1 year of brentuximab vedotin treatment.   "
242178|NCT01026246|"     Malaria is caused by a germ that people get from the bites of some mosquitoes. It kills over     2 million people each year. Many of the drugs used to treat malaria do not work as well as     they used to and researchers are exploring other vaccines to prevent malaria. The purpose of     this study is to learn if the vaccine, called EBA-175 RII-NG, is safe and if it strengthens     the body's defenses against malaria. Participants will include 60 healthy adults, ages 18-40,     recruited from Accra, Ghana. Several dosages of the vaccine will be tested for safety. The     lowest dosages of the vaccine will be tested before the next higher dose is tested. There     will be two groups for each dose, one group will receive the vaccine and the other group will     receive a placebo (salt water solution). Participants may be involved in study related     procedures for up to 398 days.   "
242179|NCT01026259|"     The purpose of this study is to determine if local warming of surgical wounds improves     healing and helps prevent infection. The investigators want to see if warming surgical     incisions improves oxygen levels and healing in skin close to the incision.   "
242180|NCT01026272|"     The investigators hypothesize that the endogenous cannabinoid signalling system has lost     homeostasis in the disease multiple sclerosis (MS). To investigate a novel action of dietary     fish oils, the investigators will administer a food frequency questionnaire to both healthy     subjects and patients with MS. The investigators will first determine if there are     differences between both populations of endogenous cannabinoids, and then determine whether     dietary intake of fish oils alters these levels   "
242181|NCT01026285|"     International Observational Registry on Schizophrenia   "
242182|NCT01026298|"     Obstructive sleep apnea (OSA) is a common but under-diagnosed form of sleep disordered     breathing (SDB). Asthma is a common disease with rising prevalence, which continues to pose     significant morbidity and costs. In spite of considerable progress in our understanding of     asthma, a large number of individuals with asthma continue to have symptoms and subsequently,     have a poor functional status, poor quality of life and increased health care costs. In many     cases no apparent cause is found and optimal therapy does not achieve its goal. While recent     data suggests that OSA is common in severe asthma, the prevalence of OSA and its predisposing     factors have not been studied.   "
242183|NCT01026311|"     The purpose of this study is to evaluate the effect of coenzyme Q10 administration in     improving mitochondrial function as measured by anaerobic threshold in older athletes on a     stable dose of statin medication.   "
242184|NCT01026324|"     This is a phase I/II trial is studying the side effects and best dose of dinaciclib and to     see how well it works in treating patients with advanced melanoma. Dinaciclib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
242185|NCT01026337|"     Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response     to treatment and help plan the best treatment.      Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in     patients with locally advanced or metastatic kidney cancer.   "
242186|NCT01026350|"     Administration of colostrum enriched with anti-Flu antibodies may alter host's response to     the flu virus.   "
242187|NCT01026363|"     The human immune system produces a protein called hCAP18 (also known as LL-37 or     cathelicidin). This protein is believed to help the body to fight infections. Studies suggest     that vitamin D may important in the production of hCAP18. This study is designed to test the     ability of two different forms of vitamin D to affect levels of hCAP18. Vitamin D and hCAP18     levels will be measured during an initial visit. Individuals who are vitamin D deficient will     be randomly assigned to receive one of two forms of vitamin D for two weeks. After this,     follow-up levels will be measured.   "
242188|NCT01026376|"     The purpose of this study is to provide Decitabine to patients with Myelodysplastic syndrome     (MDS) of all FAB (French-American-British) subtypes and Intermediate-1, Intermediate-2, and     High-Risk International Prognostic Scoring System groups, including both previously treated     and untreated patients.   "
242189|NCT01026389|"     This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography     (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal     or lower limb arterial diseases.   "
242190|NCT01026402|"     The main purpose of the study is to establish a safe dose of the drug by providing     information on any potential side effects this drug may cause and collecting data about how a     patient's cancer responds to the drug. The study will also assess the blood levels and action     of AZD2014 in the body over a period of time and will indicate whether the drug has an effect     on the types of cancer the patients have.   "
242191|NCT01026415|"     The purpose of this study is to identify brentuximab vedotin drug-drug interactions in     patients with CD30-positive cancers and to determine the main route of excretion. The study     will also assess blood drug levels in patients with renal or hepatic impairment (special     populations).   "
242192|NCT01026428|"     The objective of this study is to investigate the effect of safinamide on levodopa blood     levels, both after single and multiple dosing of safinamide . A further objective of the     study is to assess the safety and tolerability of safinamide when given together with     levodopa in the applied regimen.      For that purpose, all study participants will undergo intensive blood sampling for     investigation of levodopa levels and various tolerability examinations, such as the     measurement of vital signs (blood pressure, pulse, body temperature), recording of ECGs and     questioning to find out how the study participants are feeling. Furthermore, blood samples     will be drawn and urine tests will be performed repeatedly for safety purpose during the     course of the study.      The results of this clinical trial may be used for the drug registration of safinamide in the     future.   "
242193|NCT01026441|"     This study is intended to test the safety of the Vela100 device when used for treatment for     cellulite and circumference temporary reduction.   "
242194|NCT01026454|"     The purpose of this study is to determine whether treating HSV-2 with either valacyclovir or     acyclovir is more effective in suppressing HIV-1 virus levels in people co-infected with     HIV-1 and HSV-2.   "
242195|NCT01026467|"     This phase II trial is studying how well a frailty index and geriatric assessment works in     predicting toxicity to front-line chemotherapy in treating patients with stage IV non-small     cell lung cancer. A frailty index and geriatric assessment prior to treatment may help     identify a better treatment regimen   "
242196|NCT01026480|"     Little is known about the factors that predispose patients to complications after an ileal     pouch-anal anastomosis procedure (IPAA). Our goal is to establish a registry that     prospectively captures pre- and post-surgical data from participants. Retrospective studies     concerning IPAA outcomes and will be conducted using these data.   "
242197|NCT01026493|"     RATIONALE: Veliparib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as temozolomide. work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving veliparib together with temozolomide may kill more tumor cells.      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of     giving veliparib together with temozolomide and to see how well it works in treating patients     with recurrent glioblastoma.   "
242198|NCT01026506|"     The study was performed to investigate the effects of a dietary intervention with c9,t11-CLA     on clinical and immunological parameters in children and adolescents with allergic bronchial     asthma.   "
242199|NCT01026519|"     This is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability     and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis     patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects     each with active rheumatoid arthritis will be dosed SC.   "
242200|NCT01026532|"     The purpose of this study is to determine how a special white blood cell, the eosinophil, can     contribute to asthma. One of the characteristics of asthma is airway inflammation. Airway     inflammation in asthma may occur when an allergen is inhaled and sets up an allergic reaction     in the bronchial tubes. This reaction may lead to chest tightness, cough and wheeze. To     better understand the way in which the eosinophil can cause inflammation, the investigators     plan to study eosinophils that move in to the lung following an allergic reaction.   "
242201|NCT01026545|"     This study is a randomized, investigator blind, subject blind, sponsor-open, placebo     controlled, multiple dose escalating, sequential, parallel cohort study of PF-04287881.     Subjects will undergo screening procedures within 28 days prior to dosing. At least 1 day     after the Screening visit, eligible subjects who meet the entry criteria will be admitted to     the Clinical Research Unit (CRU) and confined in the unit until discharge on Day 15.      Approximately 60 healthy volunteers (20 volunteers of Japanese origin for Cohorts 5 and 6),     18 to 55 years of age, males and females (women of non childbearing potential only) will be     enrolled and randomized in a 4:1 ratio to treatment with either PF-04287881 or placebo within     each cohort. Each cohort will have a 10 day dosing period and each will consist of 10     subjects (8 active and 2 placebo). In each cohort, each subject will receive a single daily     oral dose of either placebo or PF-04287881 under fasted state for 10 days.   "
242202|NCT01026558|"     The primary objective of this study is to compare the pharmacokinetics (how drugs are     absorbed in the body, how they are distributed within the body and how they are removed from     the body over time) of ceftobiprole in morbidly obese patients and non-obese patients. The     secondary objectives are to assess the pharmacodynamics (the study of the action or effects a     drug has on the body) and to assess safety and tolerability of ceftobiprole in order to     support dosing recommendations in the morbidly obese population.   "
242203|NCT01026571|"     BAVgenetics is a partnership between Investigators at Brigham and Women's Hospital,     Massachusetts General Hospital and the Harvard-Partners Center for Genetics and Genomics,     dedicated to discovering the genetic causes of bicuspid aortic valve disease and associated     aortic disease.   "
242204|NCT01026584|"     The aim of the study is to investigate the efficacy and safety of aripiprazole in patients     with first episode psychosis.   "
242205|NCT01026597|"     This study will test the safety and tolerability (how the body reacts to the drug) of REGN727     compared with placebo (an inactive substance that contains no medicine) in healthy subjects.     The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic     visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be     monitored by the study staff for side effects and the body's response to the study drug.     Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood     and urine samples will be collected at some or all visits.   "
242206|NCT01026610|"     The purpose of the study is to investigate the safety and the antiviral activity of two doses     of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection     compared to entecavir 0.5 mg.   "
242271|NCT01009073|"     This is a three arm study to determine the maximum tolerated dose (MTD) of ABT-263 when     administered in combination with erlotinib (Arm A), to determine the maximum tolerated dose     (MTD) of ABT-263 when administered in combination with irinotecan (Arm B), and to evaluate     safety of ABT-263 monotherapy (Arm C).   "
242272|NCT01009086|"     The purpose of this study is to evaluate the effectiveness (improvement of signs and     symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.   "
242207|NCT01026623|"     This phase I/II trial is studying the side effects of giving cixutumumab together with     temsirolimus and to see how well it works in treating patients with metastatic prostate     cancer. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab     together with temsirolimus may kill more tumor cells.   "
242208|NCT01026636|"     This study will assess the pharmacokinetics (how drugs are absorbed, distributed in the body     and removed over time) and safety of a single dose of ceftobiprole in pediatric patients     undergoing treatment with systemic antibiotics and may be used to guide dosing     recommendations for ceftobiprole in children.   "
242209|NCT01026649|"     To evaluate the effect of a 2-stage approach to the internal jugular vein when performing a     central venous catheterization compared to the traditional one stage approach on the     incidence of hematoma formation and success rate.   "
242210|NCT01026662|"     This study will:      Evaluate the in vivo effects of treatment with eMatrixCO2 and to determine the dynamics of     their development over time following treatment.   "
242211|NCT01026675|"     The working hypothesis of this proposal is that screening for gestational diabetes mellitus     as early as the 1st trimester is efficient for detecting the forthcoming presence or absence     of gestational diabetes mellitus. The investigators long-term goal is the prevention of     gestational diabetes mellitus onset i.e. the prevention of progression to gestational     diabetes mellitus, in order to enable delivery of appropriate counselling, diagnostics and     treatment for pregnant women, as well as to improve pregnancy outcomes. Therefore, robust 1st     trimester screening criteria is needed.      The overall objective of this proposal is to determine an accurate and valid 1st trimester 1h     post 50g oral glucose challenge test plasma glucose cut-off value that is predictive of     gestational diabetes mellitus onset.   "
242212|NCT01026688|"     Diabetes is a common and serious chronic disease. However, there is a large gap between the     level of care that people should receive (based on research and guidelines) and the level of     care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the     Canadian Diabetes Association has a strategy to improve heart disease screening and treatment     for people with diabetes. This study will evaluate whether the strategy works. The focus of     the strategy was to give all family physicians in Canada a Toolkit in June 2009 to help them     delivery better care for their diabetic patients. In Ontario, only half of doctors received     this Toolkit. We will compare the quality of care received by diabetic patients whose doctors     received this Toolkit versus those who doctors did not.   "
242213|NCT01026701|"     The purpose of this study is to measure the markers related to bone metabolism before and     after the use of bortezomib injection in patients with multiple myeloma and to evaluate the     effect bortezomib injection has on bone disease.   "
242214|NCT01026714|"     The cytochrome P450 enzymes (CYP) are the major drug-metabolizing enzyme system in humans. A     great inter- individual variability affects the activity of these enzymes, and consequently     the plasma drug concentrations resulting in different pharmacodynamic effects and occurrence     of effect sides. Environmental factors, diet, drugs or genetics are responsible for this     variability. Genetic factors are very important since the majority of these enzymes are     highly polymorphic. For example, over 80 CYP2D6 allelic variants have been discovered so far     and are associated to the absence, a decrease, or an increase in enzyme activity. Most     polymorphisms were detected by adverse reactions occurring in a group within the population     after normal doses of drugs had been administrated. Those patients experiencing adverse     reactions often had a reduced capability to metabolize certain drugs. In clinical therapy,     this variability has important consequences including the lack of response to a treatment     and/or adverse drug reactions. In order to reduce these potentially unwanted events possibly     leading to sever adverse reactions or death, it might therefore be of decisive interest to be     able to assess the activity of these enzymes at the individual level. Two approaches may be     used to assess CYPs activities, genotype and phenotype. Genotype is based on DNA analysis and     polymorphism detection. Phenotype consists of administration of model drug or probe drug     metabolized by a specific CYP and a determination of a ratio between the drug and its     metabolite in plasma or urine. The principal drawback of the phenotyping methods is the urine     collection overnight or at least 8 hours after the administration of probe test. This     procedure is very tedious and time consuming for the patient as well as for the medical     staff. The test can be performed in plasma or blood 1-2 hours after probe administration.     However, this procedure is invasive and needs an important volume of blood (6 ml). Recently,     a novel approach has been developed for the quantitative determination of circulating drug     concentrations using dried blood spots (DBS) on filter paper obtained with a simple finger     prick. Due to the small blood volume required (about 10 µL) compared to conventional     sampling, this minimally invasive method provides a patient-friendly alternative for blood     collection in patient population where venous sampling is unethical or impossible     (pediatrics).      In addition, DBS sampling does not require the use of anticoagulant, plasma separation and     decreases contact with infectious material. Furthermore, dried blood spots can be easily     stored and shipped to analytical laboratories without using refrigerated devices.      Thanks to the new developments in analytical techniques (mass spectrometry), which permit     quantitative analysis from very small volume of blood. DBS sampling represents a powerful     tool for the biomedical analyses, particularly in pharmacokinetic studies where several blood     samples are needed and for phenotyping procedures.   "
242215|NCT01026727|"     This phase 2b study is designed to assess the long-term efficacy (24 weeks) of MPC-4326 in     combination with a 2-3 drug optimized background regimen (OBR) relative to the efficacy of a     3-4 antiretroviral (ARV) regimen in treatment experienced, HIV-1 infected subjects.   "
242216|NCT01026740|"     The primary objective of this study is to measure the penetration of ceftobiprole into     subcutaneous (s.c.) adipose tissue and skeletal muscle and to determine the concentration     over time of ceftobiprole in these tissues and in plasma after administration of a single     intravenous (i.v.) infusion (directly into the vein) of ceftobiprole 500 mg administered over     2 hours. The secondary objective was to further assess the safety and tolerability of     ceftobiprole after a single i.v. infusion.   "
242217|NCT01026753|"     The primary purpose of the study is to investigate the efficacy and effectiveness of a     community-based nurse managed telephone support line (Provincial Health Contact Center; PHCC)     and Colorectal Cancer Information and Screening Website in supporting Primary Care Providers     (PCP) from Winnipeg, Manitoba (Canada) in their efforts to improve colorectal cancer (CRC)     screening Fecal Occult Blood Test (FOBT) compliance in average risk men and women 50-74 years     of age. Secondary outcomes of the study involve documenting and investigating common patient     questions and comments about CRC and the FOBT during their PHCC communication(s)/Website     visits as well as procuring feedback from PCP and patients related to their experiences with     the study protocol (PCP), FOBT (patients) and PHCC/website (patients).   "
242218|NCT01026766|"     The aim of the present study was to evaluate if the combination of heat and moisture     exchanger with air forced warming blankets or warming intravenous fluids prevents     intraoperative hypothermia in obese and non obese women under target controlled     infusion-total intravenous anaesthesia (TCI-TIVA) during lower abdominal surgery.   "
242219|NCT01026779|"     The goals of this study are to see what effects the introduction of RV5(RotaTeq) vaccine has     had in the community both on the number of rotavirus-associated hospitalizations and on the     strains of rotavirus circulating in the community. The investigators will use cases of     rotavirus gastroenteritis identified on the wards at Hasbro Children's Hospital during the     2007-2009 rotavirus seasons for a case-control study to estimate rotavirus vaccine     effectiveness in preventing rotavirus-associated hospitalizations. The investigators plan to     assess rotavirus vaccine coverage in Rhode Island using the state vaccine registry and to     examine whether and to what extent rotavirus vaccine was used outside the recommended age     limits (off label) during the first 2 years of its implementation in Rhode Island. Finally     using the state child health database, KIDSNET the investigators plan to investigate the     reasons that children may not have received rotavirus vaccine in order to better target     educational efforts for parents and health care providers.   "
242220|NCT01026792|"     This phase II trial studies the effects of temsirolimus in treating patients with cervical     cancer that cannot be cured by standard therapy. Temsirolimus interferes with a protein in     cells that is part of one pathway that sends signals to stimulate cell growth and survival.     By blocking this protein cancer cells may stop growing or die.   "
242221|NCT01026805|"     This study assesses the effectiveness of intrauterine fibroid and polyp removal using the     Interlace Medical 1st generation hysteroscopic morcellator device based on a retrospective     review of medical records of women who have been treated with the device.   "
242222|NCT01026818|"     The study will include patients with localized prostate cancer who experience erectile     dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be     randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on     demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for     9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for     recovery of unassisted erectile function (without medication). An open-label extension for     three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day.     Further objectives are to evaluate the treatment satisfaction of the respective therapies.   "
242223|NCT01026831|"     This study was to compare the safety and efficacy of the preservative-free formulation of     0.0015% MK2452 (tafluprost) and preservative-free 0.5% timolol maleate in patients with     open-angle glaucoma and ocular hypertension. This study was to demonstrate that the     preservative-free formulation of 0.0015% tafluprost is non-inferior to preservative-free 0.5%     timolol maleate.   "
242224|NCT01026844|"     Erlotinib is a type of drug called a tyrosine kinase inhibitor (TKI). TKIs block a protein     called epidermal growth factor receptor (EGFR). EGFR may control tumor growth and tumor cell     survival. EGFR is found on the surface of many types of cancer cells, including non-small     cell lung cancer (NSCLC). Erlotinib is approved by the Food and Drug Administration (FDA) for     the treatment of NSCLC. Hydroxychloroquine (HCQ) is a drug approved by the FDA for treatment     of malaria, rheumatoid arthritis, and several other diseases but is not currently thought of     as a cancer treatment. Previous laboratory studies suggests that HCQ may have an anti-cancer     effect by itself in some situations, particularly when EGFR TKI drugs have been useful in the     past against the tumor. The two drugs together may be able to fight lung cancer in cases     where erlotinib is no longer effective by itself. The purpose of this research study is to     determine the highest dose of HCQ that can be given safely in combination with erlotinib. We     will also begin to look at whether HCQ plus erlotinib helps treat cancer that have become     resistant to TKI treatment after initially responding.   "
242225|NCT01026857|"     The purpose of this study is to determine whether Propionyl-L-carnitine administration may     ameliorate the illness in patients affected by mild to moderate ulcerative colitis already in     treatment with one of the standard treatments (corticosteroids excluded).   "
242226|NCT01026870|"     Mometasone furoate (MF) is a synthetic glucocorticosteroid that, when administered to asthma     patients with a dry powder inhaler (Asmanex® Twisthaler®) at dosages of 100 to 400 mcg twice     daily, has been shown to improve lung function, reduce symptoms of asthma, and reduce     frequency and severity of exacerbations by reducing airway inflammation, with a relatively     low potential to cause systemic side effects such as hypothalamic-pituitary-adrenal (HPA)     axis suppression.      An experimental formulation of MF 100 mcg delivered twice daily via a pressurized     metered-dose inhaler (MDI) also has been shown to be effective in improving lung function of     asthma patients as measured by forced expiratory volume in 1 second (FEV1). This trial is     designed to verify the effectiveness of twice daily MF MDI 100 mcg in treating asthma in     adults and adolescents previously treated with low dosages of inhaled corticosteroids (ICS),     as measured by improvement in morning FEV1 and time to first asthma exacerbation over 12     weeks of treatment.   "
242227|NCT01026883|"     The hematocrit level is defined as the ratio of plasma volume and red blood cell mass.     Determination of this level is important for the diagnosis and follow-up of various     hematological and renal disorders. In clinical practice, automated hematology analyzers are     commonly used.      Recently, a new method for hematocrit level determination has been introduced which employs     layered resonant piezoelectric sensors. In the present study this technique will be applied     in blood samples of healthy subjects and compared to a standard laboratory method.   "
242228|NCT01026896|"     This study will examine whether mentally rehearsing moving one's affected arm after stroke     will improve the quality and amount of affected arm movement. The study will enroll 100     people who have experienced a stroke > 1 year ago, and who still have difficulty moving their     affected wrists and hands. Eligible subjects also cannot have any implanted devices or metal     above the waist. Each patient will receive 10 weeks of therapy targeting their affected arms.     Half of the subjects will also be administered mental rehearsal of the exercises that they     are physically performing, while the other half will be administered stroke information and     information on additional exercises that they can perform targeting their affected arms.     Tests of arm movement and use will be given before and after intervention, as well as 3     months after intervention, to measure response to these interventions. We will also     administer brain scans before and after intervention. We hypothesize that people receiving     the mantal and physical rehearsal will show larger arm movement and use changes.   "
242229|NCT01026909|"     Legg-Calve-Perthes disease (LCP) represents the loss of blood flow to the head of the femur,     resulting in significant hip pain and potential long term disability. This study represents a     single center, randomized, prospective, controlled study comparing the treatment of LCP with     an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional     nonoperative treatment.   "
242230|NCT01026922|"     This study will test a new medical device called the SmartPill GI Monitoring System, which is     now used to diagnose gastric motility disorders in adults, in children. The study will     compare the SmartPill capsule findings to antroduodenal manometry (ADM), which is a standard     procedure currently used for the evaluation of gastric and duodenal motility in children. The     ADM studies will be done for clinical purposes and only if recommended by the patient's     gastroenterologist. The research portion of the study is limited to the use of SmartPill.   "
242231|NCT01026935|"     For the present study, 400 consecutive men with unilateral primary inguinal hernia are     randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or     light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks     without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain     than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as     well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are     needed, which may compensate for its higher cost. The patients are blinded to which mesh they     receive.   "
242273|NCT01009099|"     This study will compare the effects of exercise training and breathing retraining (using     metronome tones) to exercise training only. Exercise training lasts 12 weeks.   "
242232|NCT01026948|"     In order to confirm the feasibility of home monitoring with Monica AN 24, a licensed portable     device for measuring fetal and maternal electrocardiogram (ECG), and the feasibility of     inpatient monitoring with Monica AN 24 in patients with Propess (a vaginal licensed drug     delivery system used for induction of labour), we will perform a pilot study that will     include 20 women in each arm.      Feasibility of monitoring with Monica AN 24 both in hospital and at home will be confirmed in     a pilot study. The success will be defined as at least 10 minutes of continuous satisfactory     trace in any given hour in at least 80% of the patient.      A main study will then be conducted to assess the feasibility and acceptability of the     Propess and Monica AN24package of care for women undergoing induction of labour.      The research questions are:        1. Is outpatient induction with continuous monitoring technically feasible?        2. Does the Propess and Monica AN24 care package of care provide adequate clinical          information in line with the UK National Institute of Clinical Evidence (NICE) Guideline          for Induction of labour?        3. Is outpatient induction a concept that appeals to women?        4. What do women consider to be the advantages and disadvantages of this package of care?        5. What would women consider to be positive and/or negative outcome in future clinical          trials of outpatient induction?        6. Do fetuses with abnormal electrocardiogram (ECG) patterns have evidence of subclinically          impaired cardiac function (feasibility study)?        7. Do elevated concentrations of white blood cell components in the umbilical cord blood at          birth influence fetal electrocardiogram (feasibility study)?   "
242233|NCT01026961|"     This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500     mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy     volunteers.   "
242234|NCT01026974|"     The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension     study will be to explore antibody persistence in children at approximately 40 months of age     and to evaluate the safety, tolerability and immunogenicity of a booster dose of rMenB±OMV NZ     administered to subjects at approximately 40 months of age. Antibody persistence will be     subsequently measured at 18-20 months after these booster doses when the subjects are 60     months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be     recruited in the study to serve as a baseline comparator for assessing antibody persistence     at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ.     Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations , if     they have not already received these vaccines prior to enrollment.   "
242235|NCT01026987|"     Patients who have not had adequate blood count recovery post related or unrelated stem cell     transplant will be given a boost of T-cell depleted, enriched stem cells to hopefully     improve their blood counts.   "
242236|NCT01027000|"     RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop     the growth of cancer cells. It may also stop the patient's immune system from rejecting the     donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and     either kill them or deliver cancer-killing substances to them without harming normal cells.     The donated stem cells may replace the patient's immune cells and help destroy any remaining     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can     also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus,     and methotrexate after the transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well donor stem cell transplant works in     treating patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.   "
242237|NCT01027013|"     The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension     for the treatment of patients with dry-eye.   "
242238|NCT01008644|"     Primary hypothesis: osmolality changes influence the sensitivity of the respiratory center to     carbon dioxide, hyponatraemia causing hyperventilation, and hypernatraemia depressing     ventilation.      Secondary hypothesis: There are gender differences in the sensitivity to osmolality changes.      10 women and 10 men will on different occasions drink water or receive hypertonic saline     intravenously, in order to lower or increase plasma osmolality. The women will participate     during both faces of the menstruation cycle. On each occasion the subject´s sensitivity to     carbon dioxide will be tested, and blood samples will be drawn for analysis of blood     gases,electrolyte and osmolality.Subjects who interrupt participation before completion of     all planned occasions, will be substituted, so that 10 subjects of either sex will have     participated as planned. All results from all participants will be analyzed.   "
242239|NCT01008657|"     The primary purpose of the trial is to demonstrate that at least a 40% drop of recurrence     rate can be achieve in hepatocellular carcinoma patients treated with no touch multipolar     radiofrequency ablation technique compared to those treated with usual intranodular     multipolar technique.   "
242240|NCT01008670|"     The primary goal of this study is to develop techniques to identify the course of the phrenic     nerve in patients already undergoing cardiac resynchronization therapy (CRT) implantation or     candidates for future CRT devices undergoing implantable cardioverter-defibrillator (ICD) or     pacemaker implantation. Specifically, the study intends to identify the location and course     of the left pericardiophrenic vein, and thus the left phrenic nerve, to guide the location     for coronary vein lead placement and minimize the risk of phrenic nerve stimulation.   "
242241|NCT01008683|"     Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination     according to the clinical guidelines.      In these patients the investigators will measure the specific antibody production.   "
242242|NCT01008696|"     The purpose of this study is to compare the treatment effects of rabeprazole and lansoprazole     depending on the genotyping (process of determining the genetic constitution) of CYP2C19 in     treating reflux esophagitis (caused by gastroesophageal reflux; deterioration of the     protective lining on the inner wall of the lower esophagus); and to evaluate the cure rate of     reflux esophagitis on endoscopy (a thin flexible tube with a microscopic camera at the end     which is passed down your throat into the esophagus, stomach, and duodenum) after treatment     with rabeprazole and lansoprazole.   "
242288|NCT01009307|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is looking at blood and cheek cell samples from patients with     glioma.   "
242243|NCT01008709|"     Intracorporeal suturing and knot tying during robotic prostatectomy and laparoscopic and     robotic renal surgery have historically been considered the most technically challenging and     time consuming aspects of these procedures. With improved operative technique as well as the     use of innovative surgical devices, vascular control during these surgeries is often less     cumbersome as compared with traditional techniques. Current standard methods of hemostasis     include the use of clips, of which the most popular design is the Hemolock, a locking,     nonabsorbable plastic clip, or the use of the very expensive endomechanical stapler.     Unfortunately while they are associated with time savings in the operating room, there is a     great deal of disposable costs associated with these various devices as well as a not     insignificant device malfunction rate reported in the literature. The aim of this     case-controlled study is to evaluate the Aesculap U-clip device compared to our current     technique of vascular control using the Teleflex Hemolock clip device during minimally     invasive genitourinary surgery.   "
242244|NCT01008722|"     The study is conducted in patients with atrial fibrillation undergoing clinically prescribed     ablation. The study hypothesis is that ablation at specific sites that are identified to     'drive' the atrial fibrillation may improve the success of the ablation procedure.   "
242245|NCT01008735|"     The Gruppo Italiano Studio Linfomi has been collecting data on patients with Hodgkin Lymphoma     (HL) since 1988. This archive represents a homogeneous series of consecutive patients with     HL. The very long follow up and the availability of clinical and treatment data make it     feasible to perform a study on the gonadal toxicity related to treatment for HL.   "
242246|NCT01008748|"     The goal of this study is to learn how neighborhood and individual factors affect the ability     to stop smoking among Spanish-speaking Mexican American (MA) smokers who want to quit     smoking.   "
242247|NCT01008761|"     To determine if treatment of pre-school children with a history of wheeze who present to an     Emergency Department with an acute wheezing episode with azithromycin for 5 days will resolve     their symptoms more quickly, will require less short acting beta agonist (SABA), and allow     these children to remain symptom free for a longer period of time.   "
242248|NCT01008774|"     Primary objective:        -  Rate of complete chemotherapy induced alopecia (WHO grade III or IV, physician grading)      Secondary objective:        -  Compliance to scalp cooling procedure        -  Received number of cycles of chemotherapy in each subgroup        -  Patient perception of scalp cooling procedure        -  Side effects of scalp cooling systems   "
242249|NCT01008787|"     The goal of this behavioral research study is to learn why some African American (AA) women     choose not to exercise often and to learn if teaching African American women how to support     the exercise habits of a partner will increase their physical activity and help them to stay     more active over time.      The primary goal of the proposed intervention is:      Aim 1: To conduct formative research using semi-structured in-depth interviews and focus     groups with sedentary AA women to investigate the role and importance of social support for     PA;      Aim 2: To determine the feasibility of recruiting and implementing Culturally Appropriate     Physical Activity Motivational Interviewing (CAPMI) intervention in sedentary AA women;      Aim 3: To pilot test and evaluate the efficacy of the CAPMI in increasing PA, social support,     self-efficacy and reducing barriers to Physical Activity (PA) at post-intervention compared     to an attention control group.   "
242250|NCT01008800|"     This research is being done to test the effectiveness of two treatments aimed at increasing     language and social skills in children with autism spectrum disorder. If children show     improvement in these treatments, we hope that the availability of public services for     minority and low income families will be increased. Minority and low income families with     children between 22 and 33 months of age with Autism Spectrum Disorders may join.   "
242251|NCT01008813|"     A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The     purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French     National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with     or without adjuvant, in HIV-infected patients after one or two injections.   "
242252|NCT01008826|"     The study hypothesis tested is that broccoli sprouts are effective at altering the urinary     levels of metabolites of the hepatocarcinogen aflatoxin B1 and of the air-borne pollutant     phenanthrene in residents of Qidong, PRC, where exposures are unavoidable and high. The study     will evaluate which of two formulations of broccoli sprouts beverage, glucoraphanin-rich or     sulforaphane-rich, exhibits the best bioavailability and is most effective at modulating the     biomarkers.   "
242253|NCT01008839|"     The purpose of this study is to test a new imaging technique to help scientists study     sarcopenia, the process by which muscle becomes weaker with age.   "
242254|NCT01008852|"     This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of     SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose     of methotrexate.   "
242255|NCT01008865|"     This is a prospective, randomized study of two types of continent ileal neobladder     construction in patients undergoing cystectomy for primary bladder cancer. Patients will be     randomly assigned to have either a T-pouch or a Studer pouch constructed at the time of their     surgery. They will be followed long-term to determine the relative advantages and     disadvantages of the two types of diversion. The investigators' hypothesis is that the     inclusion of an antireflux mechanism in the T-pouch will result in significantly fewer     episodes of symptomatic urinary tract infection, and will have a lower incidence of upper     tract dilation and loss of renal function over the long term.   "
242256|NCT01008878|"     This study is a randomized, controlled and opened trial designed to compare the effects of an     interdisciplinary moderate-intensity lifestyle modification program vs. conventional     treatment by primary care physicians.      We want to show the benefits of coherent interdisciplinary care in the obesity clinic of CHUS     (Centre Hospitalier Universitaire de Sherbrooke) in comparison to the conventional treatment     in order to:        -  Improve subjects' characteristic features of metabolic syndrome: weight, waist          circumference, fatty mass, plasma lipid profile, blood pressure, fasting glycaemia, and          HbA1c;        -  Improve our patients' nutritive practices;        -  Decrease our patients' sedentary lifestyle;        -  Improve our patients' motivation to lose weight, and to improve their quality of life;          We also wish to define predictors of answer in order to better select the patients if          necessary, and evaluate the costs incurred by the health system.   "
242257|NCT01008891|"     Study Objective: To demonstrate equivalent clinical and radiologic outcomes as gold     standard (ABG) in a representative clinical model (foot and ankle fusions)      Study Hypothesis: Augment™ Injectable is an equivalent bone grafting substitute to autologous     bone graft in applications as shown by superiority analysis for safety and non-inferiority     analysis for effectiveness      Study Rationale: Evaluate a fully synthetic bone graft material to facilitate fusion in     conditions or injuries requiring bone graft in a representative clinical fusion model and     thus the opportunity to provide equivalent union rates as ABG without necessitating an     additional invasive procedure to harvest the graft   "
242258|NCT01008904|"     RATIONALE: Magnesium oxide may help relieve hot flashes in women with cancer.      PURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot     flashes in menopausal women with cancer.   "
242259|NCT01008917|"     This is a Phase I study, which means that the goal is to see if the combination of     Temsirolimus and Sorafenib is safe in patients with Hepatocellular Carcinoma. Sorafenib is a     standard treatment for Hepatocellular Carcinoma. Temsirolimus is used to treat cancer in the     kidneys. It is hoped that the addition of Temsirolimus will make Sorafenib more effective     against Advanced Hepatocellular Carcinoma, however this can not be guaranteed. The addition     of Temsirolimus to Sorafenib is not an FDA approved treatment for Advanced Hepatocellular     cancer.   "
242260|NCT01008930|"     The goal of this clinical research study is to learn if using the PEMFlex Solo II, a     high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected     to have cancer will give researchers the same or better information about the disease     compared to the images taken with a routine PET/CT.      Researchers will compare the images taken using the PEMFlex Solo II to the images taken     during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s),     magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within     the last 30 days or may have in the next 30 days.   "
242261|NCT01008943|"     The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety     and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle     Derived Cells for treatment of Stress Urinary Incontinence.   "
242262|NCT01008956|"     This study is designed to characterize the safety and immunogenicity of a' pandemic influenza     (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age.   "
242263|NCT01008969|"     The purpose of this study is to develop a practice procedure for lymphatic drainage mapping     with the intent of providing a new tool that could potentially be used for radiation     treatment planning. High-risk prostate cancer patients who are scheduled to be treated with     intensity-modulated radiotherapy (IMRT) may be eligible to enroll in this study. 99mTc-sulfur     nanocolloid, a radiopharmaceutical (tracer) will be injected by a urologist using     transrectal ultrasound guidance (TRUS)at the UCSF Urology Clinic. Participants will then     undergo SPECT/CT imaging at the UCSF Nuclear Medicine Clinic. This study will evaluate the     feasibility of transporting patients to the Nuclear Medicine Clinic for imaging within 1-3     hours after administration of 99mTc-sulfur nanocolloid.   "
242264|NCT01008982|"     Background and rationale Sjögren's syndrome (SS) is a systemic autoimmune disease     characterized by chronic inflammation of salivary and lachrymal glands, frequently     accompanied by systemic symptoms. The presence of various autoantibodies such as rheumatoid     factor (RF) and anti-SSA/SSB antibodies, as well as hypergammaglobulinemia, reflect B cell     hyperactivity. About five percent of patients with SS develop malignant B cell lymphoma,     usually of the mucosa-associated lymphoid tissue (MALT) type and most frequently located in     the major salivary glands. Currently, there is a lack of evidence-based intervention therapy     which may influence SS-related chronic inflammation and lymphoproliferation. B cells are     involved in the pathogenesis of SS, and B cell downregulation may lead to a decrease of     disease activity. Patients with more residual exocrine gland function, e.g., those with SS of     shorter duration, might better benefit from systemic therapy, as reported in a preliminary     study on the efficacy of B-cell depletion in SS.This study will examine the effect of the     drug Belimumab in patients with SS. Patients aged more than 18 years with SS may be eligible     for this study. Candidates will be screened with complete history and physical examination,     chest x-rays, and oral and eye examinations.   "
242265|NCT01008995|"     The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of     ustekinumab in the treatment of patients with moderate to severe psoriasis in China.   "
242266|NCT01009008|"     The purpose of this study is to determine whether a patient controlled tissue expander can     improve the results and patient experience in breast reconstruction. The study hypothesis is     that patient controlled expansion will lead to rapid and more comfortable outcomes than     historical precedents.   "
242267|NCT01009021|"     The purpose of this study was to evaluate the analgesic effect of oral potassium diclofenac     in patients with proliferative diabetic retinopathy submitted to retinal photocoagulation.      Two groups of patients were followed and the effect of the treatment (diclofenac plus laser)     was compared to placebo (placebo plus laser). Pain associated with treatment was recorded     using a Visual Analog Scale 15 minutes after the procedure.   "
242268|NCT01009034|"     The objective of this study is to determine if concentrations of maraviroc in semen exceed     the 50% and 95% inhibitory concentrations of HIV during the dose interval.      The secondary objective is to determine the extent of maraviroc penetration into semen by     obtaining semen to plasma ratios across the dosing interval, to determine the area under the     concentration time curve of maraviroc in semen, and to determine the variability in the     penetration of maraviroc into the seminal compartment over the maraviroc dosing period.   "
242269|NCT01009047|"     The purpose of this study is to evaluate the efficacy and safety of extended-release (ER)     paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having     symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of     emotional instability, detachment from reality, often with delusions and hallucinations     [imagining things], and withdrawal into the self) .   "
242270|NCT01009060|"     This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512     compared to placebo in patients with schizophrenia   "
242434|NCT01028040|"     This is a single centre, open label, non-randomised study to access the safety, tolerability,     pharmacokinetics and pharmacodynamics of AZD3043 following a single dose administration to     Japanese subjects.   "
242274|NCT01009112|"     Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD),     results in numerous negative consequences for patients, families, and society. Some of the     most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and     insomnia. This study will examine whether treatments specifically targeted at those sleep     disorders can improve clinical outcomes and increase health-related quality of life in     individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares     and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of     life.   "
242275|NCT01009125|"     This is a mailed survey to persons who served as living kidney donors at Saint Barnabas     Medical Center. The experimental component of this study (the clinical trial) is a randomized     trial of two monetary incentives for the living kidney donors invited to participate in the     study. Kidney donors will be randomized to receive one of two incentives in the mailed survey     packet: $2 cash vs. $5 cash. The main outcome measure is the response rate to the survey.   "
242276|NCT01009138|"     This work is supported by the Kompetenznetz Diabetes mellitus (Competence Network for     Diabetes mellitus) funded by the Federal Ministry of Education and Research (FKZ 01GI0809).      Approximately one third of diabetic patients has elevated depressive symptoms. The majority     of these patients are suffering from a subthreshold depression. In spite of the fact that     subthreshold depression has an equivalent negative impact on the prognosis of diabetes as     clinical depression, there is no specific intervention tool. The main objective of this     project is to develop a diabetes specific cognitive behavioural treatment (DS-CBT) for     diabetic patients with subthreshold depression. In a randomized trail DS-CBT is compared to     standard diabetes education. A total of 188 diabetic patients will be recruited and randomly     assigned to the two treatment conditions. The expected main outcome is the reduction of     subthreshold depression under DS-CBT in a 12 month follow up. Secondary variables are     improvement of glycaemic control, quality of life, diabetes self-management as well as     reduction of health care costs and modification of inflammatory parameters.   "
242277|NCT01009151|"     The proposed pilot project is aimed at assessing the feasibility, acceptability and impact of     a web-based home tele-monitoring system among congestive heart failure patients at the     University of Michigan Health System. The intervention consists of daily reporting via the     internet on health parameters, such as weight, blood pressure, heart rate and heart failure     symptoms. In addition to symptom and data reporting, the system provides links to educational     material on heart failure and reminders for self-care measures. It is designed as an     inexpensive, user-friendly, and clinically effective system.      Each patient will be provided with a unique name and password, and will be instructed on how     to use the self-management website.      The proposed home monitoring system study holds the potential to improve the lives of heart     failure patients treated at the University of Michigan Health System by empowering them to     participate actively in their care and to reduce the risk of hospitalization. As heart     failure represents the most common hospital diagnosis related group (DRG)among the elderly,     this study offers a significant public health benefit.   "
242278|NCT01009177|"     The study is designed as a multicenter, double blind, parallel-group, placebo-controlled,     randomized, event driven Phase II study of DTIC with or without bosentan as first-line     treatment in patients with stage IV melanoma.   "
242279|NCT01009190|"     Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy     in adult patients with advanced solid tumors   "
242280|NCT01009203|"     The primary hypothesis of this study is that the addition of mammalian target of rapamycin     (mTOR) blockade to conventional epidermal growth factor receptor (EGFR) blockade will result     in synergistic clinical activity in Squamous Cell Carcinoma of the Head and Neck (SCCHN),     consistent with preclinical xenograft data. Patients will be treated with the combination of     temsirolimus and erlotinib, at the previously established Maximal Tolerated Dose (MTD). The     primary signal of efficacy will be progression free survival (PFS), anticipating that PFS     will be prolonged compared to historical PFS in SCCHN patients treated with erlotinib or     cetuximab monotherapy.   "
242281|NCT01009216|"     The objectives of this study are to assess the cerebral spinal fluid (CSF) pharmacokinetics     and the plasma/CSF pharmacokinetic/pharmacodynamic relationship of ABT-384 in healthy male     volunteers.   "
242282|NCT01009229|"     Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for     donation according to official guidelines. An assessment of salt sensitivity, 11 beta HSD     activity, 24 hour blood pressure, urine collection and physical exam will be performed prior     nephrectomy and 14, 52, 156, 208 days post-nephrectomy.   "
242283|NCT01009242|"     The primary objectives are to determine the relationship between blood levels of CDP6038 and     suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV)     infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of     CDP6038 will also be evaluated.   "
242284|NCT01009255|"     This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512     compared to placebo in patients with mild to moderate Alzheimer's disease   "
242285|NCT01009268|"     The investigators' aim is to assess the effect of a model of preoperative as well as early     postoperative care, treatment and rehabilitation in a dedicated orthogeriatric ward in a     single-blind randomised study.      The investigators' main hypothesis is that an orthogeriatric service may improve long-time     cognitive outcome.   "
242286|NCT01009281|"     This study will assess the safety and tolerability of AIN457 in patients with moderate to     severe Crohn's disease who already participated and completed the core trial CAIN457A2202.   "
242287|NCT01009294|"     Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It     is caused by a mutation in the gene for dystrophin, a protein that is important for     maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility     that leads to weakness and loss of walking ability during childhood and teenage years. A     specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of     DMD/BMD in approximately 10-15% of boys with the disease. Ataluren (PTC124) is an orally     delivered, investigational drug that has the potential to overcome the effects of the     nonsense mutation. This study is a Phase 2a trial that will enroll boys with nonsense     mutation DMD/BMD who have lost independent mobility due to the disease. This study will     evaluate the safety and tolerability of ataluren (PTC124) and will also evaluate efficacy     outcomes in this patient population.   "
242289|NCT01009320|"     Magnetic fields may interfere with the function of cardiac pacemakers. A magnetic drape to     hold surgical instruments is widely used in surgery. The use of this drape on pacemaker     patients has not yet been tested. Our objective is to conduct a clinical study to evaluate     the potential interference of the surgical magnetic drape on patients with cardiac     pacemakers. We are testing the magnetic drape on forty patients in the pacemaker clinic. The     totality of the drape is applied over the pacemaker and depending on the result, the drape is     either folded in two over the pacemaker or the magnets are applied individually up to the     totality of the drape, 70 magnets. Thereafter, the drape is pulled in increments of 3 cm     caudally until the interference is ceased. Results are in process as we are presently     actively recruiting.   "
242290|NCT01009333|"     This study assessed the effect of different InterStim rate settings on voiding diary     outcomes. Specifically, the study evaluated how 3 different rate settings affected the number     of urinary incontinent episodes per day collected through a voiding diary. The study also     evaluated how the 3 different rate settings affected other voiding diary measures including     number of voids per day, degree of urgency before each void, number of pads used per day, and     number of fecal incontinent episodes, questionnaires, and adverse events.   "
242291|NCT01009346|"     1. Phase I: To estimate the Maximum Tolerated Dose (MTD) of RAD001 in combination with          cetuximab and cisplatin for treatment of metastatic squamous cell cancer of the head and          neck (SCCHN).        2. Phase II: To estimate the progression free survival (PFS) of RAD001 at MTD in          combination with weekly cetuximab and cisplatin on days 1 and 8 of each 28 day cycle in          patients with recurrent or metastatic SCCHN,      Secondary Objectives        1. To estimate the complete and partial response rate of RAD001 at MTD in combination with          weekly cetuximab and cisplatin on days 1 and 8 of each 28 day cycle in patients with          recurrent or metastatic SCCHN,        2. To explore if the clinical activity of this regimen correlates with markers of the          EGF-R/mTOR pathway in tumor tissue by serial sampling of tumor.        3. To explore the role of FDG PET imaging as an early indicator of response to this          combination.   "
242292|NCT01009359|"     PET (positron emission tomography) imaging with BAY85-8102 F-18, DPA-714 for investigation of     neuroinflammation pattern in probable Alzheimers patients versus healthy volunteers and     radiation dosimetry in healthy volunteer.   "
242293|NCT01009372|"     Many people spanning from air traffic controllers to simple production line workers share     regular compulsive breaks to revert fatigue whilst they work. This is uncommon for medical     operators - a macho image is still as prevalent in real life as it is in countless TV series.      We report on the first clinical trial on regular intraoperative breaks. For one time we     turned our scientific curiosity to ourselves. This included the intraoperative collection of     body fluids and required transparency which was not easy to obtain. It was rewarded with     striking results: Regular intraoperative breaks lowered significantly the operators stress     hormone levels, improved error-performance testing results and musculoskeletal fatigue     scores. Subjectively the breaks enhanced the practitioners satisfaction.      Surprisingly the operator's breaks were not at the cost of the patient: because the did not     prolong the overall operation time at all and - in our setting- they significantly increased     of cardiac output and urine production.   "
242294|NCT01009385|"     Cervical epidural steroid injections        -  The hanging drop (HD) technique is commonly used for identifying the cervical epidural          space.        -  The hanging drop (HD) technique is using the negative pressure in the epidural space.        -  The subject of debate whether the epidural space exhibits negative pressure.        -  In a previous study, EP might be influenced by body position        -  No report or peer-reviewed literature to demonstrate the cervical epidural pressure          (CEP) now.      The hypothesis of this study        -  There is a difference in the cervical epidural pressure between in the prone and sitting          positions        -  To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and          compared in the two groups.        -  Using a closed pressure measurement system        -  Under fluoroscopic guidance.   "
242295|NCT01009398|"     Thoracic operations are known to be painful and requiring an adequate postoperative pain     therapy. A well documented technique to achieve postoperative analgesia is the use of     paravertebral catheters. Theoretically the thoracic paravertebral block results in an     unilateral thoracic anaesthesia. However, in the daily clinical practice it remains unclear     whether catheters are placed correctly into the paravertebral region. The investigators'     experiences with paravertebral catheters suggest that there may be many displacements of     catheters since the pain control is reduced compared to epidural analgesia.      The aim of this prospective observational clinical trial is to postoperatively evaluate the     exact location of paravertebral catheter placed for thoracoscopic interventions by using the     classical land-mark puncture technique. After radiological detection of the catheter     position, the spread and distribution of contrast dye injected through the catheters will be     evaluated.   "
242296|NCT01009411|"     Objective of the study: to obtain new data on the dynamics of the labor process, cervix     dilatation and head station on the labor process and to develop a new progress indices.      Background: the best method used today to supervise the labor process is to follow cervix     dilatation and head station. Today, the physician or the midwife use manual examination to     estimate cervix dilatation and head station. This examination is perform many times in a     normal labor process, and even more if there is any delay. The information from these     examinations is inaccurate and non-continuous. In case of delay in the labor process, the     delay will diagnosed late, because the frequency of the manual examination is about once an     hour.      With the assistance of the BirthTrack device we can get continuous data on the labor process     and get indices to estimate the labor process progress without the use of vaginal (manual)     examination.      40 women in an active labor will take part in the study.      Method: by connecting sensors to the woman abdomen, to the cervix and to the baby head we     follow the cervix dilatation and the fetus head station.   "
242297|NCT01009424|"     This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of     RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic     Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled     doses of R7103, as compared with placebo. The target sample size is approximately 30     individuals.   "
242299|NCT01009450|"     This study included group (A) (60 patients with liver cirrhosis and complaining of gall     stone) in whom LC was done using traditional method (TM) by clipping both cystic duct and     artery and dissection of gall bladder from liver bed by diathermy, and group (B) (60 patients     with liver cirrhosis and complaining of gall stone) LC was done using harmonic scalpel (HS)     closure and division of both cystic duct, artery and dissection of gall bladder from liver     bed by harmonic scalpel. The Intraoperative and postoperative parameters were collected     included duration of operation, postoperative pain, and complications.   "
242300|NCT01009463|"     The Purpose of this study is to assess the efficacy and safety of three strengths of the     FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)   "
242301|NCT01020162|"     Neuralgic pain caused by entrapment of peripheral nerves is an often overlooked cause of     chronic pelvic pain. The objective of the present study was to assess pain and quality of     life in women with pain caused by entrapment of the ilioinguinal nerve, iatrogenic after     surgery but also found without previous surgery. In a controlled prospective cross-over study     19 women were randomized either to medical treatment or to resection of the nerve.     Statistically significant improvements were found after surgical resection.   "
242302|NCT01020175|"     350 patients with early leukemias were assigned to receive peripheral blood or bone marrow     transplantation; the occurrence of acute and chronic graft versus host disease, survival,     transplantation-related mortality, and relapse rates were compared.   "
242303|NCT01020188|"     Paroxysmal nocturnal haemaoglobinuria (PNH) is a rare disease which results in breakdown of     the red blood cells and bone marrow failure. It is associated with an increased risk of blood     clots. Until recently, treatment has been with blood transfusions and in patients with a     blood clot, blood thinners. A new treatment called eculizumab is now standard for patients     who require regular blood transfusions. It works in the majority of patients by preventing     the breakdown of red blood cells. This can eliminate the need for blood transfusion and     reduce the risk of blood clots. It is not well understood why patients with PNH are at high     risk of blood clots. The investigators plan to use specialised blood tests to assess the     stickiness of the blood before starting eculizumab treatment and monthly after starting     treatment. The investigators will compare these tests with standard tests of clotting.   "
242304|NCT01020201|"     Risk factors for postoperative nausea and vomiting(PONV) such as past history of PONV and/or     motion sickness, non-smoking status, female gender, planned opiate use for post-operative     analgesia were identified in white people. Whereas, risk factors for PONV in female patient     with mongolian race were not clear. As a different life style and genetic background, new     risk factors may associate with PONV in this population. The present study is a prospective     cohort study to identify risk factors for PONV within 24 postoperative hours in chinese     female patients underwent gynecology operative under general anesthesia.   "
242305|NCT01020214|"     The objective of this study was to investigate the bioequivalence of Mylan's olmesartan     medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg     tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under     fasting conditions.   "
242306|NCT01020227|"     Background: This randomized controlled trial investigates the effectiveness of an Integrative     Therapies (IT) health education intervention in improving physical and psychological     functioning in female patients after coronary artery bypass graft (CABG).      Methods: One hundred female cardiac surgery patients were assigned to either an intervention     or standard care control group. Patients in the intervention group were given a cardiac yoga     video, a guided imagery audiotape, instruction in diaphragmatic breathing, and an educational     booklet outlining recommendations for dietary change. Patients were followed for 6 months by     a health educator who provided ongoing education and encouragement and were assessed at 6     weeks and 6 months post surgery to determine between group differences on physical     functioning and psychological distress using the SF-36 and the Profile of Mood States   "
242307|NCT01020240|"     The purpose of this study is to promote a prevention of the complications using an elaborate     guide effective and easy to understand.   "
242308|NCT01020253|"     The purpose of this study is to evaluate whether alendronate and alfacalcidol are effective     on prosthetic or lumbar spine BMD after total hip arthroplasty.   "
242309|NCT01020266|"     The purpose of this study is to evaluate the neuroprotective effect of electroacupuncture     pretreatment in patients undergoing cardiac surgery as an preventive sequela in a randomized     and controlled clinical trial. In addition, to investigate the role of inflammatory responses     in the precess of the protection.   "
242310|NCT01020279|"     1. Comparison of the effect of ketoprofen Transfersome® gel (KTG) to placebo gel (PG) on          muscle pain of the calf caused by eccentric contractions        2. Comparison of the effect of KTG to celecoxib (CE) on muscle pain of the calf caused by          eccentric contractions        3. Comparison of the effect of celecoxib (CE) to oral placebo (OP) on muscle pain of the          calf caused by eccentric contractions   "
242311|NCT01020292|"     This phase I trial will determine safety, dose-limiting toxicities (DLT) and maximum     tolerable dose (MTD) of the protease inhibitor, Nelfinavir (NFV), when given with     chemoradiotherapy as post-operative therapy for glioblastoma multiforme (GBM). Oral NFV is a     standard therapy for patients with HIV and the safety of 1250 mg BID NFV is well-established.     Case studies have also reported that HIV patients have received radiotherapy for cancer,     while on 1250 mg BID NFV. This is the first trial of oral NFV and chemoradiotherapy for GBM     patients. Although unacceptable toxicity is unlikely, two NFV dose levels (625, and 1250 mg     BID) will be evaluated in a cohort escalation design of 3-6 subjects. At the MTD, 19     additional subjects will be enrolled to generate pilot data on radiographic response and to     evaluate further toxicity. A maximum of 31 subjects will be enrolled on the trial.   "
242312|NCT01020305|"     This study evaluates if temsirolimus causes a reduction in the serum levels of     prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer     (CRPC).   "
242375|NCT01021124|"     The aim of this study is to estimate the usefulness of a T cell-based assay (i.e.     Quantiferon-Gold In-Tube assay) for diagnosis of latent tuberculosis infection (LTBI) in bone     marrow transplant recipients. For this purpose, the investigators enrolled bone marrow     transplant recipients and observed the developement of tuberculosis after the     transplantation.   "
242313|NCT01020318|"     Background:        -  Traumatic brain injury (TBI) is a significant injury in the Armed Forces, but it is also          common in the general population. This condition poses significant challenges for both          diagnosis and therapy. However, the biological and neurological reasons for TBI remain          poorly understood and are in need of more in-depth study.        -  The National Institutes of Health is collaborating with several military medical centers          and research units in a multi-year study of TBI in civilian and military patients. In          anticipation of these research projects, the Clinical Center s Rehabilitation Medicine          Department needs to become familiar with the instruments they will likely need to          evaluate this group of subjects.      Objectives:        -  To evaluate potential test instruments in patients with TBI.        -  To evaluate patient tolerance of an extensive battery of assessments and the time          required to complete the assessments.        -  To improve staff competencies on new or novel assessments of the TBI patient population      Eligibility:        -  Individuals 18 years of age and older who have been diagnosed with a traumatic brain          injury in the past 5 years.        -  Healthy volunteers 18 years of age and older who have had no instances of significant          head trauma.      Design:        -  This study requires approximately 3 days of outpatient or inpatient evaluation.        -  Subjects will undergo cognitive and neuropsychological tests, physical assessments,          speech and language evaluation, and balance testing. Tests will be given orally, in          writing, and on computers. The testing will be done in blocks of 2 to 3 hours, with rest          periods as needed.        -  Subjects may undergo any or all of the following assessments and screening tools, as          determined by the researchers:        -  Cognitive, quality of life, and functional assessments        -  Speech, language, and swallowing assessments        -  Physical functional performance and environment assessments (including balance testing)        -  Subjects will remain under the care of their own health care providers while          participating in this study.   "
242314|NCT01020331|"     Tau, a protein in the cerebrospinal fluid CSF is believed to be elevated in amyotrophic     lateral sclerosis (ALS) patients. The investigators believe that Tau is truly a marker of     increased neuronal death from any disease process. It is been shown that Memantine can     inhibit and reverse the abnormal hyperphosphorylation of Tau and therefore the investigators     are looking at the efficacy of Memantine at 10 mg twice a day (BID) to see if disease     progression correlates with possible changes in Tau in ALS patients based on ALS Functional     Rating Scale (ALSFRS) scores.   "
242315|NCT01020344|"     A randomised controlled trial will be performed to evaluate the effects of lung volume     reduction surgery (LVRS) in patients with COPD on systemic inflammation, oxidative stress,     endothelial function, arterial stiffness and blood pressure. We hypothesize that LVRS will     lead to a reduction of systemic inflammation, oxidative stress, arterial stiffness and blood     pressure and to improved endothelial function.      For this purpose 30 patients with severe/very severe COPD (GOLD III-IV) and pulmonary     emphysema who are to undergo LVRS will be randomised to one of two groups: group 1 receiving     immediate LVRS and group 2 receiving LVRS after a delay of 3 months.      Measures of systemic inflammation, oxidative stress, endothelial function, arterial stiffness     and blood pressure will be measured at baseline and 3 months after surgery and no surgery,     respectively (group 2 receiving surgery only after a delay of 3 months will serve as control     group) to investigate the effects of LVRS on the described outcomes.   "
242316|NCT01020357|"     Apnea of prematurity is a common condition that is usually treated with methylxanthines.     Methylxanthines are adenosine receptor blockers that have powerful influences on the central     nervous system. However, little is known about the long-term effects of methylxanthines on     the developing brain.      The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine     for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of     methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage     of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive     either caffeine or placebo, and are currently receiving detailed neurocognitive and     behavioral assessments in the CAP trial.   "
242317|NCT01020370|"     The primary goal of this study will be to explore the reparative and regenerative potential     of alemtuzumab in RRMS patients who are participating in the CARE MS I and CARE MS II studies     using conventional and non-conventional MRI sequences.   "
242318|NCT01020383|"     This is a multicenter, randomized and open-label Phase II study to compare the safety,     tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro®     in high risk PCI patients.      Patients will receive standard treatment with acetylsalicylic acid (ASA) plus clopidogrel and     heparin. Eligible patients will be randomly assigned to receive open-label study treatment     with either ALX-0081 or ReoPro®. Patients will be stratified according to PCI type (elective     or ad-hoc) and stent type (bare metal stent or drug eluting stent).   "
242319|NCT01020396|"     The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability of     Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0.75% and 3M     Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0.75% to establish clinical     equivalence in the treatment of bacterial vaginosis.   "
242320|NCT01020409|"     The aim of the study is to evaluate a clinically and economically most effective diagnostic     algorithm for prediction of inflammatory response related complications in patients     undergoing heart surgery with use of cardiopulmonary bypass.   "
242321|NCT01020422|"     The aim of this study is to determine the impact of reduction mammaplasty on sexuality and     depression predictors in women with macromastia.   "
242322|NCT01020435|"     The investigators propose a prospective randomized 2 arm parallel observer-blinded phase II     clinical study comparing a distinct method of upper cervical chiropractic manipulation to a     sham technique in 50 individuals with stage I hypertension (systolic blood pressure (SBP):     140-159 mm Hg; diastolic blood pressure (DBP):90-99 mm Hg).   "
242323|NCT01020448|"     The purpose of this study is to evaluate the effect of an initial hormonal treatment     gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in     patients with histologically confirmed and advanced stages of prostate cancer. Their     characteristics, according to risk factors such as PSA and Gleason score will be determined     at baseline and 1, 3 and 6 month post-treatment.   "
242324|NCT01020461|"     The objective of this study is to evaluate the effectiveness of Accuvein to facilitate venous     blood sampling and placement of peripheral intravenous catheters in adults. This clinical     protocol is designed to determine whether using Accuvein increases the ease and efficiency of     venous cannulation (as perceived by the operator), decreases the time to effective     cannulation, decreases the number of sticks, and decreases the patient's perception of the     pain.   "
242325|NCT01020474|"     This study will compare pregabalin with placebo over a 15 week period in adolescents with     fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.   "
242435|NCT01028053|"     This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in     identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from     aMCI to a b-amyloid associated clinically probable Alzheimer's disease.   "
242326|NCT01020487|"     Part 1: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 μg     paricalcitol capsules in children ages 10 to 16 years with moderate to severe chronic kidney     disease (CKD Stages 3 and 4).      Part 2: To determine the safety and efficacy of paricalcitol capsules as compared to placebo     in decreasing serum intact parathyroid hormone (iPTH) in children ages 10 to 16 years with     moderate to severe chronic kidney disease with an initial 12 weeks of double-blinded study     drug followed by a minimum of 12 weeks of open-label active drug.   "
242327|NCT01020500|"     The purpose of the study is to assess the responder rate as defined by the achievement of the     primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in     accordance with routine practices.   "
242328|NCT01020513|"     This is an observational study examining the workflow dynamics and training requirements that     support effective use of subcutaneous hydration delivery (a newly FDA approved Baxter     product) compared to standard intravenous hydration/medication delivery. Emergency     departments already using both Subcutaneous Recombinant Human Hyaluronidase and standard IV     hydration will be enrolled. Patients will be receiving the hydration method selected by their     emergency department physician and the investigators will then observe:        1. Patient Throughput             -  Efficiency of patient care and treatment areas             -  Safety of patient care and treatment areas             -  Support Service processes that impact patient flow        2. Clinical Outcomes             -  Time to conversion from dehydration to hydration'             -  Rate of complications        3. Satisfaction             -  Staff satisfaction with Subcutaneous hydration vs. Intravenous hydration             -  Patient satisfaction with Subcutaneous hydration vs. Intravenous hydration   "
242329|NCT01020526|"     The main purpose of this study is to evaluate the long-term safety of pregabalin in     adolescent patients who participated in the previous fibromyalgia study (A0081180) and who     wish to recieve open-label pregabalin   "
242330|NCT01020539|"     Allogeneic stem cell transplantation (AlloSCT) followed by targeted immune therapy Gemtuzumab     Ozogamicin patients with acute myeloid leukemia (AML)/juvenile myelomonocytic leukemia     (JMML)/myelodysplastic syndromes (MDS) will be safe and well tolerated.   "
242331|NCT01020552|"     A descriptive post-intervention study designed to provide data to decision-makers at the     Kenyan Ministry of Health, the Extending Service Delivery Project (ESD), and Pathfinder     International about whether and how to scale-up the ESD Project's postabortion care (PAC)     services package. Approximately three months of data will be collected following the     introduction of postabortion care job aids in eight public sector health facilities in     Central Province and Nairobi, Kenya. Postabortion clients and providers will be interviewed;     facilities providing PAC services will be inventoried using facility checklists.   "
242332|NCT01020565|"     The objectives of this study are to demonstrate that entecavir has antiviral activity with     undetectable at Week 48, and to assess the safety and the pharmacokinetic in Japanese     patients given entecavir at each dose of 0.1 and 0.5 mg for 52 weeks   "
242333|NCT01020578|"     Impaired glucose tolerance is associated with an increased risk of developing cardiovascular     disease and atherosclerosis for reasons not yet totally understood. Previous studies     evaluated the kinetics of plasma LDL and a faster removal rate of free cholesterol in     normolipidemic patients with diagnosed arterial coronary disease and deposits of this     cholesterol on the blood vessel walls. This disassociation of the cholesterol may suggest a     new mechanism for not only the genesis but for the progression of arterial coronary disease.     The objective of this research was to study the plasma kinetics of free cholesterol and     cholesterol ester in impaired glucose tolerance patient, asymptomatic for coronary artery     disease (CAD), to elucidate mechanisms involved in atherogenesis in these patients.   "
242334|NCT01020591|"     The purpose of this study is to determine if the use of osteopathic manual therapy can     influence the vascular supply to the knee, knee range of motion, balance and knee pain, in a     group of subjects with knee osteoarthritis. It is also the objective of this study to     determine if there is a difference between the osteopathic evaluation and the combination of     an osteopathic evaluation and treatment.   "
242335|NCT01020604|"     The reports on relationship of obesity and biochemical or clinical recurrence of prostate     cancer are controversial. Several reports have shown that obesity is associated with     increased risk of biochemical or clinical failure after radical prostatectomy. Other     prospective studies have shown no adverse effect of obesity on long-term outcomes after     prostatectomy. Limited reports are available on the impact of obesity on prostate cancer     progression after radiotherapy. Primary: to assess percentage recurrence rate among normal     weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.     Secondary: to determine the Quality of Life differences among normal and overweight or obese     prostate cancer patients by a Quality of Life questionnaire   "
242336|NCT01020617|"     Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and     it is likely that this is also the case in children (Ley et al., 2005). It has also been     shown that the gut microbiota is different in obese individuals compared to normal weight     individuals and that the microbiota seems to have a role in fat storage (Backhead et al,     2004).      Intervention study with overweight and normal weight school age children. The children will     be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be     collected, and anthropometric measurements (weight, height, skin folds) will be recorded     before and after the intervention. The dynamic of the microbiota of the GI will be monitored     by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will     be analysed. Blood samples will be analysed to evaluate how the intervention influence the     systemic polarization of the immune response by means of cytokine analyses. Furthermore,     blood pressure, blood lipid profile and early markers of metabolic syndrome will be     evaluated. Hypotheses This study will examine if overweight in children is associated with a     different intestinal microbiota and if a change in microbiota caused by probiotics can modify     inflammation and risk factors for the metabolic syndrome.   "
242347|NCT01020760|"     The purpose of this study is to determine the effect of postoperative posturing on the     outcome of macular hole surgery. Current practice is divided; some individuals are advised to     posture face-down for 10 days and others are advised that posturing is unnecessary. By     evaluating the effect of posturing in a prospective randomised controlled trial the     investigators hope to determine best practice, enabling surgeons and patients to make     informed decisions regarding postoperative management.   "
242337|NCT01020630|"     This trial will be conducted to evaluate the efficacy, safety and tolerability of SUNITINIB     as add-on therapy with a widely used second-line palliative FOLFIRI chemotherapy in patients     with chemo-refractory advanced or metastatic adenocarcinoma of stomach or lower esophagus     (mGC).      There is a clear scientific rationale for the use of Sunitinib to treat patients with mGC.     Despite recent therapeutic advances, the median overall survival (OS) in patients with mG is     still ≤ 12 months. Therefore, newer agents with novel mechanisms of action are desperately     needed for treatment of these patients.   "
242338|NCT01020643|"     The purpose of this study is to compare the administration of a standard anesthetic drug     (propofol) using an automatic, expert-based system versus a manually controlled system by the     anesthesiologist. In addition, the performance of the decision support system will be     evaluated.   "
242339|NCT01020656|"     Purpose: To establish the prevalence of anticoagulant, aspirin, and clopidogrel use in     patients undergoing vitreoretinal surgery, and to compare the outcome of peribulbar     anesthesia between users and non-users.   "
242340|NCT01020669|"     Background:      - Recent research has suggested that prenatal exposure to drugs may affect specific brain     processes, including working memory, stress response, and decision making. However, most of     the research on the effects of prenatal drug exposure in humans has been conducted early in     life, and very little is known about effects of prenatal drug exposure during the crucial     brain development period that takes place during puberty and adolescence. The biological and     psychological changes associated with puberty may increase adolescents' sensitivity to     prenatal substance exposure. Researchers are interested in using functional magnetic     resonance imaging (fMRI) scans to study brain function and learn more about the effects of     prenatal drug exposure on adolescents.      Objectives:      - To examine the effects of prenatal substance exposure on working memory, decision making,     and normal brain activity in adolescents.      Eligibility:      - Adolescents between 12 and 17 years of age who are enrolled in a larger follow-up study of     children exposed to drugs in utero.      Design:        -  The study will involve a single outpatient session with two fMRI scans that will test          working memory and decision-making processes.        -  Participants will have brief medical history, a physical examination, and a urine test          for drugs of abuse.        -  Participants will then be trained on the working memory and decision-making tasks before          having an initial MRI scan to provide a baseline reading.        -  The fMRI scans will take 40 to 45 minutes each, and participants will have break in          between as needed.   "
242341|NCT01020682|"     Apathy has been reported to occur after subthalamic nucleus stimulation (STN-DBS), a     treatment of motor complications in advanced Parkinson's disease (PD). It is not known     whether postoperative apathy is related to dopamine withdrawal or a side effect of STN DBS.     The researchers investigated potential predictors of apathy, and the effect of dopamine     agonist treatment.   "
242342|NCT01020695|"     In this study the Quantitative Electroencephalography and low resolution topographic analysis     of chronic Post-traumatic stress disorder and normal subjects will be compared.   "
242343|NCT01020708|"     This Phase I study will be a closely monitored trial of a small number of subjects to     establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations:     ALTH12-1:4 and ALTH12-2:4. The study will be conducted in two parts. The first part will be     the assessment of the safety and tolerability of a single dose of ALTH12-1:4 or the     comparator, mesalamine (4.0g 5-ASA) followed by an assessment of repeated administrations of     study drug (ALTH12-1:4 or comparator) for 6 weeks. The second part will be the same     assessment for ALTH12-2:4. Three subjects will be enrolled in each cohort: 2 to receive     ALTH12 enema therapy and 1 subject to receive comparator enema therapy. A total of up to 9     patients will be enrolled in this study, allowing for up to 3 replacement or additional     patients.   "
242344|NCT01020721|"     Primary congenital glaucoma, which presents at birth or in infancy, if left untreated, may     threaten vision. The incidence of congenital glaucoma varies among different geographic     locations and ethnic groups.      Three genetic loci for primary congenital glaucoma (GLC3A in 2p21, GLC3B in 1p36, GLC3C in     14q24.3) were identified. CYP1B1 (cytochrome P450 1B1 ) gene, in the GLC3A locus is the main     known gene and different CYP1B1 mutations has been described.      The genetic characteristics in south Korean patients with primary congenital glaucoma have     not been reported yet and the genotype-phenotype correlations, the prognosis and the genetic     counseling have not also been established. This study represents the first repot about the     rate of CYP1B1 mutations, the genotype-phenotype correlations in south Korean patients with     primary congenital glaucoma.      Patients with primary congenital glaucoma and their family will be analyzed for CYP1B1     mutations by direct sequencing of polymerase chain reaction fragments. Primary congenital     glaucoma will be diagnosed according to the clinical parameters by glaucoma specialists.     Patients were classified to several groups according to the pattern of mutations. Clinical     parameters and genotype correlation will be compared between groups   "
242345|NCT01020734|"     RATIONALE: Giving chemotherapy before a donor bone marrow or peripheral blood stem cell     transplant helps stop the growth of cancer cells. It also helps stop the patient's immune     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are     infused into the patient they may help the patient's bone marrow make stem cells, red blood     cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can     make an immune response against the body's normal cells. Giving cyclosporine and methotrexate     before and after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well donor stem cell transplant or bone marrow     transplant works in treating patients with acute myeloid leukemia in remission.   "
242346|NCT01020747|"     This phase I single center open labeled study is planned to assess the safety and     tolerability of bevacizumab for treating patients with bilateral Recurrent Respiratory     Papillomatosis (RRP). Approximately 20 patients will receive bevacizumab directly injected     into the vocal folds. Patients who enroll in the protocol will be injected with bevacizumab     in one vocal fold that represents the more diseased of the two folds. A sham injection with     saline will be administered to the other vocal fold as the control. This therapy will be     administered once every 6 ± 1 week for 6 months, with the same vocal fold selected for the     initial treatment always getting the drug injection. The investigator will also treat lesions     by laser photoangiolysis of both vocal folds using the 532 nm potassium-titanyl-phosphate     (KTP) laser.   "
242348|NCT01020773|"     Spontaneous breathing trial (SBT) has long been thought to be a essential process before     extubation. In this study,the investigator hypothesized that SBT could be not essential     during weaning from ventilator and investigated whether weaning could be better done without     a spontaneous breathing trial in non-COPD（COPD, Chronic Obstructive Pulmonary Disease）     critically ill patients. This study has revealed, for the first time, that compared with use     of SBT in discontinuing ventilator process, patients underwent successful extubation without     SBT. For this subset of patients the findings suggest that SBT may be excluded preceding     extubation in a general intensive care population.   "
242349|NCT01020786|"     To investigate efficacy and safety of the combination with pemetrexed plus carboplatin,     followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer     (NSCLC) who receive at least one dose of the induction therapy.   "
242350|NCT01020799|"     The purpose of this study is to prove the principle that treatment with AZD7268 reduces     depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.   "
242351|NCT01020812|"     To determine the efficacy and toxicity of TACE combined with SBRT   "
242352|NCT01020825|"     The purpose of this extension is to investigate and confirm the long-term (6 months) safety     and efficacy of the preceding FATT-1 trial [ClinicalTrials.gov identifier: NTC00475410],     which studied patients with perianal fistula treated having received adipose-derived adult     stem cell (ASC)and/or fibrin glue.   "
242353|NCT01020838|"     To determine the sensitivity and specificity of the visual assessment of tracer uptake in the     Florbetaben PET images compared to histological verification of the presence or absence of     cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of     truth   "
242354|NCT01020851|"     National recommendations state that patients with a history of transient ischemic attack     (TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive     medication and lifestyle modification, with a goal of reducing blood pressure (BP) to <120 mm     Hg systolic BP and <80 mm Hg diastolic BP. Statin treatment and lifestyle modification is     also recommended for post-stroke and post-TIA patients with elevated cholesterol levels or a     history of stroke or TIA with an atherosclerotic cause. Despite the clear benefits of     secondary stroke prevention, there is a gap between evidence and implementation in clinical     practice. By a randomized controlled trial, the investigators will test whether a tailored,     telephone-delivered transtheoretical model-based behavioral intervention will improve     adherence to treatment in veterans with a history of TIA or stroke, thereby leading to better     control of BP and cholesterol levels, as compared to an attention placebo.      The primary specific aims of this project are to:        -  determine whether a behaviorally tailored intervention (TI) can effectively lower BP          after 6 months of counseling as compared to an attention placebo (AP) in veterans with a          history of stroke or TIA        -  assess whether the TI is effective in improving adherence to diet after 6 months of          counseling in veterans with a history of stroke or TIA.      Secondary aims are to        -  assess whether the TI is effective in improving cholesterol levels in post-stroke          veterans after 6 months        -  evaluate whether the TI is effective in improving adherence to antihypertensive and          lipid-lowering medications after 6 months of counseling in veterans with a history of          stroke or TIA        -  determine whether the TI is effective in improving adherence to exercise recommendations          after 6 months.      To answer this, veterans (n=190) with a history of stroke or TIA will be randomized equally     to the TI, which will use the transtheoretical framework to provide 6 monthly counseling     phone sessions about adherence to diet, medication, and exercise recommendations, and the AP,     in which 6 monthly counseling phone sessions about non-stroke-related health topics will be     provided. Participants will make in-person visits at baseline and 6 months. BP (3 measures     taken at least 5 min apart) and dietary sodium are the primary outcomes, while secondary     outcomes will be total cholesterol/high density lipoprotein ratio, adherence to     antihypertensive and lipid-lowering drugs, and exercise adherence.   "
242355|NCT01020864|"     This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of     cetuximab in combination with carboplatin and vinorelbine as second line treatment in     patients with recurrent or metastatic head and neck cancer who have progressed during or     after treatment with first line cisplatinum.   "
242356|NCT01020877|"     The primary object of this study was to evaluate the relative bioavailability of the test     formulation of metronidazole vaginal gel with the already marketed reference formulation     MetroGel-Vaginal Gel® in healthy adult female subjects.   "
242357|NCT01020890|"     The purpose of this study is to provide data on the gastroesophageal reflux disease (GERD)     prevalence as percentage of patients with upper gastrointestinal (GI) symptoms that are     identified with GERD using the Gerd-Q Questionnaire.   "
242358|NCT01020903|"     Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and     vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize     this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of     post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive     decadron and ondansetron. Half the patients will receive aprepitant in addition. The other     half will receive placebo. The study will be randomized and double-blind.   "
242359|NCT01020916|"     Experimental studies and previous clinical trials suggest an improvement in mortality and     neurological function with hypothermia after cardiac arrest. However, the accrued evidence is     inconclusive and associated with risks of systematic error, design error and random error.     Elevated body temperature after cardiac arrest is associated with a worse outcome. Previous     trials did not treat elevated body temperature in the control groups. The optimal target     temperature for post-resuscitation care is not known. The primary purpose with the TTM-trial     is to evaluate if there are differences in all-cause mortality, neurological function and     adverse events between a target temperature management at 33°C and 36°C for 24 hours     following return of spontaneous circulation after cardiac arrest.   "
242360|NCT01020929|"     The investigator hopes to learn the incidence of needle placement in both the epidural and     intravascular space, and learn mixed epidural-intravascular pattern related to needle type,     gauge, and level of injection. We also hope to evaluate the length of fluoroscopy time when     using real time fluoroscopy during contrast dye injection, evaluate the radiation exposure to     the hands of the physician during this protocol, and confirm the incidence fo intravascular     injection and sensitivity of needle flash of blood, In the lumbar spine, vascular contrast     patterns are more than twice as likely to appear simultaneous to the anticipated epidural     pattern, than they are to occur alone. This is important since practitioners are more likely     to miss a vascular pattern that occurs simultaneous to epidural spread, than they are to     occur alone. The incidence of intravascular penetration in cervical transforaminal epidural     injections is known to exceed that of lumbar injections, however no study has determined the     incidence of simultaneous epidural and vascular injection in the cervical spine. This study     may prove that real time fluoroscopy during contrast injection is warranted to prevent     intravascular injection and resultant side effects to support this as standard of care.      Intermittent fluoroscopy can yield false-negative results for intravascular injection when     simultaneous epidural and intravascular injection occurs. This could lead to an increased     risk of complication from intravascular injection of medications and reduce overall efficacy.     No studies to date have quantified the incidence of needle placement located in both the     intravascular space and epidural space simultaneously.   "
242364|NCT01020981|"     This project will add an evaluation/research component to an existing peer outreach program,     now implemented for over 1100 soldiers in the Michigan Army National Guard. Preliminary work     will be completed in three areas. We will conduct semi-structured interviews with soldiers,     Buddies, and National Guard leadership and develop and pilot test survey items relevant to     implementation. Further, we will develop and pretest survey items relevant to determining     soldier symptomatic and functional status. We will also conduct a small feasibility study,     fielding the newly developed survey to a representative sample of recently returned National     Guard members from Michigan and Indiana, to determine response rates and veteran willingness     to allow access to linkable PDHA/PDHRA data and health services data. Finally, we will     construct a merged, de-identified longitudinal dataset comprised of Post-Deployment Health     Assessment and Reassessment data, Military Health System/TRICARE, and VA services data from     National Guard soldiers in Michigan and comparison states of Indiana and Ohio. This will     allow a longitudinal assessment of services initiation and retention for the entire Guard     populations in these states.   "
242365|NCT01020994|"     The aim of the study is to determine the efficacy and safety of topical application of     LAS41003 in comparison to LAS189962 and LAS189961 in the treatment of superinfected eczema.   "
242366|NCT01021007|"     Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation   "
242367|NCT01021020|"     This randomized, single dose, three-way crossover study will evaluate the bioequivalence of     two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed     combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting     conditions. It will also determine the bioavailability following a standard high-fat meal and     evaluate the safety and tolerability of the test product.   "
242368|NCT01021033|"     Background:        -  Stroke, also known as acute cerebrovascular attack, is the leading cause of long-term          disability worldwide. Stroke survivors are often left with permanent physical and mental          disabilities.        -  Many stroke patients receive different therapies in an attempt to improve their          independence and quality of life. However, current strategies are focused on the acute          stage after stroke and are of limited influence in improving stroke outcome. One of the          main problems of patients who have suffered a stroke is the difficulty in using the hand          on the opposite side of the affected hemisphere of the brain; to date, researchers have          no successful means to improve the hand function in chronic stages of stroke.        -  Researchers are interested in developing a pool of individuals for further research into          hand and motor function after a stroke.      Objectives:      - To perform a screening evaluation of patients referred with stroke to determine their     eligibility for current and future protocols studying the effects of stroke on the nervous     system and motor function.      Eligibility:      - Individuals who have experienced a single stroke on only one side of the brain that     occurred at least 3 months prior to participation in the screening study. Individuals must     have some residual hand motor function.      Design:        -  Participants in this study will be recruited from patient referrals.        -  Eligible participants will undergo a 4- to 5-hour screening with a medical history,          physical and neurological examination, stroke evaluation, and an anatomical magnetic          resonance imaging (MRI) of the brain. The screening visit may be done over the course of          more than one day, if needed for patient convenience or test availability.        -  In addition to the initial outpatient visit, subjects may remain enrolled in this study          for up to 15 years and may be contacted to see if they qualify for new branch studies.          Subjects may be re-examined up to once per year while they remain in this protocol to          confirm ongoing eligibility. The re-examination visits will involve a neurologic          evaluation and possible repeat MRI.        -  No clinical care will be provided under this protocol..   "
242369|NCT01021046|"     The purpose of this study is to study whether deep anterior lamellar keratoplasty (DALK)     using acellular tissue will promote corneal graft survival in high risk patients.   "
242370|NCT01021059|"     Background:        -  Recombinant human interleukin-15 (rhIL-15) is a substance that is naturally produced in          the body that has many properties that increase the activity and strength of the immune          system, the body s natural defense system. It is hoped that rhIL-15 can boost or          strengthen patients immune systems and restore immune responses against cancer and          infectious diseases like HIV.        -  rhIL-15 is being studied in patients with malignant melanoma, an aggressive type of skin          cancer, and in patients with renal cell carcinoma, a type of kidney cancer that has          spread to other parts of the body. Researchers are interested in determining if rhIL-15          can help stimulate the immune system and aid in the treatment process for cancers that          have not responded well to standard therapies.      Objectives:        -  To determine whether rhIL-15 is safe and effective in the treatment of metastatic          malignant melanoma or metastatic renal cell carcinoma        -  To examine how the body processes rhIL-15 after each infusion and determine how it acts          on the treated cancer.      Eligibility:        -  Patients older than 18 years of age that have been diagnosed with metastatic malignant          melanoma or metastatic renal cell carcinoma that has not responded to standard          treatments.        -  Eligible patients may not have received prior treatment with interleukin-2.      Design:        -  Prior to treatment, patients will have baseline blood tests and imaging scans.        -  Participants will be admitted to an in-patient unit of the NIH Clinical Center for this          treatment. rhIL-15 will be given intravenously once a day for 12 consecutive days, for a          total of twelve doses of the drug. The injection of rhIL-15 will take about 30 minutes.          Patients will be evaluated daily before each treatment and more frequently if necessary.        -  During the 12-day treatment and for at least 42 days from the start of the treatment,          patients will be closely followed for possible side effects and for tumor response.          Blood will be drawn frequently for monitoring purposes, and other procedures such as          chest x-rays and imaging scans will be performed to monitor the state of the tumor and          the patient response to treatment.        -  After completing the rhIL-15 treatment and discharge from the hospital, patients will          have an evaluation with a member of the research team once a week from the end of the          treatment period to 42 days from the start of the treatment.        -  Study doctors may ask patients to return for evaluation (including blood draws) at 3 and          6 months after the completion of the treatment, checking for potential long-term effects          or toxicity of the treatment.      Background:        -  Recombinant human interleukin-15 (rhIL-15) is a substance that is naturally produced in          the body that has many properties that increase the activity and strength of the immune          system, the body s natural defense system. It is hoped that rhIL-15 can boost or          strengthen patients immune systems and restore immune responses against cancer and          infectious diseases like HIV.        -  rhIL-15 is being studied in patients with malignant melanoma, an aggressive type of skin          cancer, and in patients with renal cell carcinoma, a type of kidney cancer that has          spread to other parts of the body. Researchers are interested in determining if rhIL-15          can help stimulate the immune system and aid in the treatment process for cancers that          have not responded well to standard therapies.      Objectives:        -  To determine whether rhIL-15 is safe and effective in the treatment of metastatic          malignant melanoma or metastatic renal cell carcinoma        -  To examine how the body processes rhIL-15 after each infusion and determine how it acts          on the treated cancer.      Eligibility:        -  Patients older than 18 years of age that have been diagnosed with metastatic malignant          melanoma or metastatic renal cell carcinoma that has not responded to standard          treatments.        -  Eligible patients may not have received prior treatment with interleukin-2.      Design:        -  Prior to treatment, patients will have baseline blood tests and imaging scans.        -  Participants will be admitted to an in-patient unit of the NIH Clinical Center for this          treatment. rhIL-15 will be given intravenously once a day for 12 consecutive days, for a          total of twelve doses of the drug. The injection of rhIL-15 will take about 30 minutes.          Patients will be evaluated daily before each treatment and more frequently if necessary.        -  During the 12-day treatment and for at least 42 days from the start of the treatment,          patients will be closely followed for possible side effects and for tumor response.          Blood will be drawn frequently for monitoring purposes, and other procedures such as          chest x-rays and imaging scans will be performed to monitor the state of the tumor and          the patient response to treatment.        -  After completi...   "
242371|NCT01021072|"     The purpose of this study is to block interleukin-1 alpha activity with a True Human     monoclonal antibody, thus interrupting the inflammatory response that supports tumor     growth/metastasis and which drives the cachexic process.      An adaptive design will be employed which will allow for the exploration of different dosing     regimens, as well as tumor types that show preliminary evidence of efficacy.   "
242372|NCT01021085|"     Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56     days as confirmed by artificial reproductive technology (ART). The samples will be used to     develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal     plasma or urine.   "
242373|NCT01021098|"     Recently, the emergence and rapid global dissemination of novel swine-origin influenza A     virus (H1N1) with unique epidemiologic characteristics has heightened awareness and concern     of this viral pathogen, and its potential for major disruption of both civil and military     stability. Although advances in medical and scientific technologies have improved our basic     understanding of respiratory disease, many questions about the epidemiology and immunology of     ARI remain unanswered. This study plans to initiate a multi-site, multi-disciplinary research     collaboration, termed the Acute Respiratory Infection Consortium (ARIC) for the purpose of     studying the etiology, epidemiology and immunology of influenza-like illness (ILI) in order     to describe the natural history and risk factors for disease, as well as the characteristics     of the host immune response.      At the core of the ARIC is the proposed observational, longitudinal study of the Natural     History Study of ILI among active duty military members, healthy retirees, and their     dependents recruited from both inpatient and outpatient settings of military treatment     facilities (MTF) in the continental US to be followed for a total of four (4) visits over a     28-day period. Additionally, the investigators also propose to conduct a household-based     study of influenza (Family Transmission Study) in which individuals who have a     laboratory-confirmed influenza illness will be recruited and enrolled along with their family     members for the purpose of studying transmission of influenza within households. Taken     together, these studies will establish a longitudinal cohort of ILI among active duty members     and their families, as well as a repository of biological specimens relevant to the     epidemiology and immunology of infection. Ultimately, these studies will serve as a solid     foundation on which future investigations of ARI epidemiology, treatment and prevention can     be based.   "
242377|NCT01021150|"     Primary Objective:        -  To determine the maximum tolerated dose based on the incidence of dose limiting toxicity          and the maximum administered dose of ombrabulin in combination with cisplatin          administered every 3 weeks in patients with advanced solid tumors.      Secondary Objectives:        -  To assess the overall safety profile of the combination therapy.        -  To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR          258063, and cisplatin in combination.        -  To evaluate anti-tumor activity of the combination therapy.   "
242378|NCT01021163|"     The purpose of this study is to study the effects of N-acetylcysteine on pulmonary function     in high-risk patients undergoing off-pump coronary bypass surgery.   "
242379|NCT01021176|"     The purpose of this study is to determine whether the blood pressure medication, diltiazem,     will temporarily decrease the sense of smell when given in a nasal spray which will then     reduce food intake.   "
242380|NCT01021189|"     The primary aim of this study is to assess the safety and tolerability of AZD1446 following     single and multiple ascending doses of an orally administered solution of AZD1446 in healthy     young and elderly Japanese subjects.   "
242381|NCT01021202|"     The purpose of this study is:        -  to evaluate the optimal time-point for percutaneous dilation tracheostomy in COPD          patients in terms of duration on mechanical ventilation, length of stay on ICU and          mortality;        -  to evaluate the rate of infections and infectious complications of tracheostomized COPD          patients;        -  to evaluate the spectrum of pathogens in tracheostomized and intubated COPD patients;        -  to evaluate the amount of sedatives used in mechanically ventilated COPD patients;        -  to assess the quality of life in COPD patients tracheostomized after 3 or after 10 days.   "
242382|NCT01021215|"     The goal of this clinical research study is to learn how zileuton alone or the combination of     zileuton and celecoxib may affect certain chemicals in the body that may be linked with a     risk for smoking-related lung disease. These effects will be measured by a urine test   "
242383|NCT01021228|"     The purpose of this study is to compare the impact and outcome of continuous volatile     anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in     liver surgery.   "
242384|NCT01021241|"     The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of     single intravenous doses of Uricase-PEG 20.   "
242385|NCT01021267|"     Assessment in an open trial if a standardized saw palmetto preparation has a positive     influence on sexual dysfunctions in patients with BPH and sexual dysfunctions.   "
242386|NCT01021280|"     Parathyroid hormone (PTH) gland calcium sensing receptor (CASR) regulates PTH secretion. CASR     is also expressed in nephron thick ascending limb (TAL). Bartter syndrome (BS), a     normotensive hypokalemic tubulopathy, may be due to mutations in different TAL channels,     including the potassium channel ROMK. Mutations in CASR may also cause BS through its effects     on ROMK function. However, it is unknown whether ROMK mutations exert any effects on CASR     function and PTH physiology. Preliminary data from our center shows that PTH levels were     specifically elevated in type II (where ROMK is mutated) and not in type IV (where another     gene, Barttin is defective) BS, without a common explanation. We assume that the mutation in     ROMK may cause a dysregulation of PTH secretion via possible interaction with CASR.      The purpose of this study is: to investigate the PT-gland function and regulation in BS.      Methods: Patients with BS type II and IV and normal controls will undergo a standard protocol     of controlled ionic hypo- and hypercalcemia, during which PTH secretion, phosphate balance     and calcium excretion will be followed. Calcium Vs PTH response curves will be generated and     compared.      Expected impact and benefit: the results of this study will help understand the mechanisms of     PTH regulation beyond CASR.   "
242387|NCT01021293|"     The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when     administered to healthy Chinese infants at 2, 3 and 4 months of age.   "
242388|NCT01021306|"     At any given time, 10 million Americans suffer from temporomandibular disorders (TMD), with a     lifetime prevalence of 45% and costs for direct care exceeding $2 billion/year. Little     evidence exists regarding the efficacy of specific conservative interventions used to treat     TMD and currently there is no gold standard of care that is widely accepted by the dental     or medical community. This study is a prospective, randomized 4 arm parallel observer-masked     pilot study comparing: 1) Activator Methods Chiropractic Technique (AMCT), 2) a conservative     dental approach with reversible interocclusal splint therapy, 3) a sham AMCT, and 4) a     self-care only group, which includes a standard checklist of self-care jaw relaxation     techniques, for a total of 80 patients with chronic myofascial TMD.   "
242389|NCT01021319|"     The aim of the study is to evaluate the use of combined fluid attenuated inversion recovery     (FLAIR) imaging and diffusion weighted imaging (DWI) as surrogate marker of lesion age within     the first 6 hours of ischemic stroke in order to identify patients ≤ 3 or ≤ 4.5 hours of     symptom onset in a large multicenter study hours of ischemic stroke. The investigators     hypothesize that the pattern of a visible lesion on DWI together with a negative FLAIR     (DWI-FLAIR mismatch) will identify patients ≤ 3 hours of symptom onset with >80%     specificity and positive predictive value.   "
242390|NCT01021332|"     Clinical study to examine the safety, tolerability and efficacy of long-term combination     therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract     symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage     component.   "
242391|NCT01021358|"     This is a single dose, open-label, single or multiple center study to determine the     interaction of ketoconazole with ABT-263 in approximately 12 subjects with cancer.   "
242392|NCT01021371|"     The aim of this study is to investigate the impact of a joint effort towards intensifying the     collaboration and communication between hospital and general practice.   "
242393|NCT01027026|"     The investigators will make a prospective study in which they will look at the economics and     security of the treatment of patients with acute coronary syndrome.      The investigators want to do a randomized trial. One group will be treated as they have been     treated at Ullevål University Hospital (UUS) in recent years, and the other group will be     returned to their refering hospital the same day. The objective of this study will be to     provide increased knowledge about whether the rapid discharge from the intervention center is     associated with differences in costs or security.   "
242395|NCT01027052|"     Polyphenols belong to the largest group of secondary metabolites produced by plants, mainly,     in response to biotic or abiotic stresses such as infections, wounding, UV irradiation,     exposure to ozone, pollutants, and other hostile environmental conditions. It is thought that     the molecular basis for the protective action of polyphenols in plants is their antioxidant     and free radical scavenging properties. These numerous phenolic compounds are major     biologically active components of spices, aromas, essential oils, and traditional medicines.     In order to investigate the impact of spice polyphenols on postprandial cytotoxic lipid     peroxidation products (MDA) levels in humans, the investigators propose to achieve the     following specific aims using a randomized crossover study design:        1. To determine the effect of a ground beef patty meal with and without spices on          postprandial levels of plasma malondialdehyde (MDA).        2. To determine the effect of a ground beef patty meal with and without a spice blend on          MDA accumulation in urine.      This study will determine whether spice polyphenols exert a beneficial effect by inhibition     of the absorption of MDA. These findings may help to explain the potentially harmful effects     of oxidizable fats found in foods and the important benefit of dietary polyphenols in     ameliorating this potentially harmful effect.   "
242396|NCT01027065|"     This study is designed to evaluate the safety of biological active dose of a new experimental     drug, IL-7, in combination with anti viral therapy and vaccine in patients with Hepatitis B     chronic infection.   "
242397|NCT01027078|"     The investigators hypothesized that patients with Obstructive Sleep Apnea (OSA) who are free     of any cardiovascular disease will have early microcirculatory changes that are unique to     OSA, and therefore would resolve with treatment of OSA.   "
242398|NCT01027091|"     Hypocalcemia is the complication, after total thyroidectomy, that usually determines the     length of hospital stay.Serum calcium levels is a quick and cost-effective practice to     recognise hypocalcemia in the postoperative follow up.      OBJECTIVE: The objective of this perspective study is to determine if consecutive     postoperative serum calcium levels early after total thyroidectomy can be used to identify     patients who are unlikely to develop significant hypocalcemia and can be safely discharged     within 24 to 48 hours postoperative.   "
242399|NCT01027104|"     The purpose of this project is to evaluate the efficacy of a web-based curriculum designed to     teach pediatric practitioners how to provide injury prevention anticipatory guidance,     emphasizing firearm injury prevention in a clinic setting. Data will be collected regarding     the curriculum's effectiveness using a web-based questionnaire which will be administered to     pediatric residents prior to, immediately post, and six months following completion of the     curriculum. Pre- and post-test questionnaires will be compared. Residents will also be asked     to evaluate the curriculum by completing a survey. We hypothesize that the curriculum will     improve residents' knowledge, attitudes and beliefs, and self-efficacy regarding firearm     injury prevention anticipatory guidance.   "
242400|NCT01027117|"     This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in     healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at     the discretion of the sponsor. Three treatments are:      Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed     with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood     samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours     post dose in each period. Tolerability and safety will be assessed by reported adverse events     during each study period.   "
242401|NCT01027130|"     The purpose of this study is to show that a certain protein called haptoglobin protects     against preeclampsia which is a common pregnancy complication.   "
242402|NCT01027143|"     This project will assess the effectiveness of omega-3 fatty acid supplementation in     controlling asthma symptoms among obese asthmatics, and will assess if a person's genes     influence response to treatment (personalized medicine). This project may improve our ability     to treat asthma and our understanding of the link between obesity and asthma.   "
242403|NCT01027156|"     The purpose of this study is to determine whether a High Intensity exercise intervention can     elicit cardiovascular disease protection in adolescents.   "
242404|NCT01027169|"     The primary purpose of this study is to investigate the pharmacokinetics (behavior of the     compound in the body) of safinamide in patients with different degrees of hepatic (liver)     impairment in comparison to matched subjects with normal hepatic function.   "
242405|NCT01027182|"     The investigators hypothesize that the concentration-time profile of raltegravir is different     in cells than that in plasma. Intracellular raltegravir concentrations may be higher and its     half-life longer than in plasma. This may explain the efficacy of raltegravir despite     variable plasma concentrations.   "
242406|NCT01027195|"     The present prospective, single-center, clinical trial is designed to evaluate the hemostatic     efficacy of the hemostatic sealer Aquamantys 6.0™ in patients managed with total hip     arthroplasty (THA). It is hypothesized that Aquamantys 6.0™ can improve hemostasis following     total hip arthroplasty. Comparison of the functional and clinical results between THA     patients having been exposed to Aquamantys 6.0™ versus a control group will be analyzed using     several outcome measures including the Harris Hip Score and a pain scale. The primary     variable of interest is transfusion requirements - specifically, number of patients managed     with blood transfusion during the hospital stay after surgery. However, of secondary interest     will be: 1) number of units transfused, 2) estimated intraoperative total blood loss, 3)     change in pre- and post-operative hemoglobin levels, 4) total narcotic usage during hospital     stay, 5) length of stay, 6) functional and pain outcomes (Harris Hip Score and Pain Scale),     and 7) adverse events.   "
242409|NCT01027234|"     The main purpose of this study is to assess the safety and tolerability of AZD8418 after     single increasing oral doses.      Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the     study drug enters and leaves the body and how your body acts on the study drug) of AZD8418.     Part B of the study will assess the effect of food on the safety and pharmacokinetics of     AZD8418.   "
242444|NCT01028170|"     The purpose of this study is to compare high dose furosemide in combination with low volume     hypertonic saline solution (2.4%) with intermittent pulse dose furosemide in patients with     pre treatment kidney function impairment. The hypothesis is that it will provide effective     diuretic response and have a beneficial effect on preservation of renal function as compared     to pulse furosemide in patients with pre-treatment renal impairment (GFR < 60 mL/min).   "
242410|NCT01027247|"     Frequently glaucoma is not controlled with clinical treatment (eyedrops) or laser surgery     to control your eye pressure. If this raised pressure is sustained over a long period of time     it can lead to permanent damage to the optic nerve (glaucoma) and in severe cases it can     result in blindness. You also have cataracts, an opacification of the natural lens inside the     eye that is impairing your vision. To prevent further vision loss due to glaucoma, your     doctor has recommended glaucoma filtration surgery to lower your eye pressure, and cataract     surgery at the same time to improve your sight.      The use of the anti-metabolite (Mitomycin-C) during the operation is currently the drug of     choice to improve surgical outcome for glaucoma filtration surgery. Mitomycin-C is a potent     antiscarring agent that reduces the amount of scar tissue produced after surgery which leads     to better control of eye pressure. Although this potent drug is effective in increasing     surgical success, its use is related to a higher risk of post surgical complications, some of     which are sight threatening.      The Collagen Matrix Implant is a biodegradable implant (absorbed naturally by tissue), made     from porcine collagen, which reduces scar tissue formed after glaucoma filtration surgery     without the use of Mitomycin-C. This means that you could be less likely to have a failed     glaucoma filtration surgery, and consequently, a poor eye pressure control. In addition, the     risk of surgical failure may be reduced because with this technique, we will not be using     potent drugs. However, the long-term effect of the OculusGenTm implant in glaucoma filtration     surgery is not fully known.      The aim of the study is to determine whether the OculusGenTm implant can equal the success     rate of Mitomycin-C in controlling eye pressure, without the potentially sight threatening     complications associated with Mitomycin use. And at the same time, this study aim to     determine if the implant can reduce potential complications related to glaucoma surgery when     compared to the combined surgery augmented with anti-proliferative agents.      This study will recruit 66 subjects from patients attending the Singapore National Eye Centre     over a period of 12-24 months.   "
242411|NCT01027260|"     Patients suffering from Irritable Bowel Syndrome with predominant constipation will be     provided with the study medication. The study medication will be evaluated for its efficacy     in relieving the symptoms   "
242412|NCT01027273|"     The purpose of this study is to evaluate if a peer-led stroke recurrence prevention     intervention, versus usual care, will help reduce risk factors for recurrent strokes among     adults in Harlem.   "
242413|NCT01027286|"     Vitagel® is an FDA approved class III medical device. It is a surgical hemostat, which has     been shown to control bleeding during orthopaedic, cardiac, hepatic, and general surgical     procedures. The product is a thrombin/collagen suspension which works in combination with the     patient's own plasma to form a fibrin/collagen clot.      The present prospective, randomized controlled trial is designed to evaluate the efficacy of     Vitagel® for reducing blood loss and pain in patients managed with unilateral total knee     arthroplasty (TKA). It is hypothesized that the use of Vitagel® may lead to less blood filled     knees, and thus to a greater improvement in postoperative pain scores when compared to the     control group. The two arms of the study will include:        1. experimental group in which Vitagel® is used unilateral TKA        2. control group representing our current standard of care (no Vitagel®)      A comparison of the functional and clinical results between these two groups will be     conducted using several outcome measures including the KOOS, SF-12 version2 and pain scores     through the previously IRB approved OrthoMidas registry. The primary variable of interest is     blood loss, based on hemoglobin drop during the postoperative hospital stay. Of secondary     interest will be; 1) pain levels in the PACU, 2) pain scores for all postoperative days, 3)     average pain for the entire hospital stay, 4) length of stay, 5) patient satisfaction at     discharge, 4 weeks postoperative, and 12 weeks postoperative, and 6) functional scores at 4     and 12 weeks postoperative.   "
242414|NCT01027299|"     This trial will investigate the clinical and haemodynamic effects of temporary biventricular     pacing after cardiac surgery. Subjects with poor left ventricular systolic function will     receive either temporary biventricular pacing or 'standard' post-operative pacing for 48     hours.      The investigators hypothesis that reversal of cardiac dyssynchrony will improve tissue     perfusion and cardiac haemodynamics after surgical revascularisation. This will shorten     post-operative recovery in cardiac ITU.   "
242415|NCT01027312|"     To determine the clinical usefulness of a refined third-generation instrument - The     Assessment of Ability Related to Vision (AARV) in establishing the amount of disability,     charting the detrimental effects of progressive disease and establishing the beneficial     effects of treatment   "
242416|NCT01027325|"     The alarming increase in the prevalence of obesity is a cause of great concern given its     association with many adverse health conditions, including insulin resistance and type 2     diabetes, which are associated with increased cardiovascular disease (CVD) risk. The primary     objective of this project is to identify effective dietary strategies, focused on     carbohydrate quantity and starch digestibility, to improve outcome variables associated with     CVD risk in insulin resistant individuals who express components of the atherogenic     lipoprotein phenotype (ALP). Current dietary guidelines emphasize substitution of     carbohydrate calories for total and saturated fat calories for prevention and management of     chronic disease. Yet, we and others have shown that high-carbohydrate diets increase the     expression of the ALP, characterized by increased plasma triglycerides, reduced HDL     cholesterol, and increased levels of small, dense LDL particles, and that this phenotype is     reversed by moderate carbohydrate restriction. We have also shown that expression of stearoyl     coenzymeA desaturase (SCD), an enzyme involved in triglyceride synthesis, is reduced with     carbohydrate restriction and that this change is correlated with plasma triglyceride     response. While carbohydrate restriction is effective for management of ALP, the role of     starch quality has not been addressed. Furthermore, there has been no study of the effects of     resistant vs. digestible starches incorporated into high- vs. lower carbohydrate diets. Since     isolated reports suggest that increased intake of resistant starch lowers plasma     triglycerides and postprandial insulinemia, we hypothesize that starch quality is an     important determinant of components of ALP, and that this may be mediated in part by reduced     adipose tissue SCD expression. Aim 1 and of this proposal will address this hypothesis by a     controlled dietary intervention in 52 insulin resistant men and women in which changes in     plasma lipids, lipoproteins and lipogenic gene expression will be determined after     substituting resistant starch for digestible starch in a high- vs. lower-carbohydrate diet.     In Aim 2, the fasting and postprandial glucose and insulin responses to a resistant vs.     digestible starch meal will be measured to test the hypothesis that starch digestibility     improves glycemic and insulinemic control in a way that relates to diet-induced changes in     plasma lipids and lipoproteins.   "
242417|NCT01027338|"     This is a pilot randomized controlled trial of feasibililty and prelimnary effects of a 12     week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary     disease   "
242418|NCT01027351|"     The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of     this extension study will be to explore antibody persistence at approximately 40 months of     age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV     NZ administered to subjects at approximately 40 months of age. Antibody persistence will be     subsequently measured at 18-20 months after these booster doses when the subjects are 60     months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be     recruited in the study to serve as a baseline comparator for assessing antibody persistence     at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ.     Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations, if     they have not already received these vaccines prior to enrollment.   "
242494|NCT01028820|"     This is an 8 week research study of aripiprazole (abilify) which is used to reduce irritable     behaviors in autism spectrum disorders. All participants will receive active study     medication. Participants will also receive diagnostic and cognitive evaluations at no cost.     Participants will be required to undergo two fMRI (functional magnetic resonance imaging     scans) where we will take pictures of your brain while performing simple tasks.   "
242419|NCT01027832|"     Mechanically Ventilated patients in the intensive care unit (ICU) often present with fever,     and purulent sputum, but without radiological evidence of pneumonia.      These patients may have tracheobronchitis. Some suspect that this condition precedes the     development of pneumonia. Antibiotic treatment in tracheobronchitis is controversial.      The investigators will recruit patients with tracheobronchitis and randomize them into 2     groups. One group will be treated with antibiotics and the other group will serve as control.   "
242420|NCT01027845|"     This study will aim to evaluate the immunogenicity, safety and reactogenicity of     GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when     co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy     Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of     age.   "
242421|NCT01027858|"     The investigators will conduct a proof-of-concept study to provide preliminary evidence of     efficacy of aerobic-based exercise training for maintaining cognitive function, executive     function, and everyday function in adults with mild vascular cognitive impairment.   "
242422|NCT01027871|"     Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of     treatment with a new basal insulin analog or with insulin glargine.   "
242423|NCT01027884|"     The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary     function, motor function, muscle strength and quality of life in patients with DMD.     Furthermore, the safety and tolerability of idebenone was assessed.   "
242424|NCT01027897|"     The study hypothesis is to measure how the drug doripenem is cleared from the body of     critically ill trauma patients. The investigators will measure blood drug concentrations and     calculate how much the drug distributes in the body and how fast it is removed from the body.     There is little information on how drugs are cleared in critically ill patients and the wrong     dose of a drug could make it ineffective. The investigators will use this information to     predict the most reasonable dose to treat infections effectively in these patients.   "
242425|NCT01027910|"     The purpose of this research study is to determine the safety and maximum tolerated dose of     PCI-24781 that can be given safely with doxorubicin (phase I) and the safety and efficacy of     PCI-24781 when used in combination with doxorubicin (phase II) in patients with advanced     sarcomas. The study drug, PCI-24781, is believed to regulate genes involved in tumor cell     growth. The other study drug, doxorubicin, is considered a standard chemotherapeutic     treatment for advanced sarcoma patients. We hypothesize that combining PCI-24781 with     doxorubicin can overcome chemoresistance to doxorubicin.   "
242426|NCT01027923|"     In this phase I extension study, the investigators seek to test the safety of both higher     doses of plerixafor as well as intravenous dosing to maximize inhibition of the target,     CXCR4.   "
242427|NCT01027936|"     To collect three dimensional retinal measurements of the optic disc and the macula lutea on     healthy normal subjects using the 3D OCT-1000 Mark II for the purpose of developing a     normative database that is stratified by age.   "
242428|NCT01027949|"     This study provides, or continues to provide, UT-15C SR (treprostinil diethanolamine) to     eligible patients with pulmonary arterial hypertension who have completed protocols     TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any     additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the     long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise     capacity after one year of treatment.   "
242429|NCT01027962|"     The purpose of this study is to examine whether an intensive computerized intervention     targeted on improving central auditory and visual processing and executive functioning can be     implemented in youths aged 10-19 with psychotic spectrum disorders, what developmental     modifications are needed particularly for the younger participants, and whether it is     possible to develop an appropriate, blinded control intervention.   "
242430|NCT01027975|"     Laparoscopic fundoplication is increasingly performed in paediatric surgery. Many types of     fundoplication are performed, each has advantages and disadvantages. The Nissen operation is     the most frequently performed procedure in the U.K., however it can be associated with     post-operative dysphagia. The relative benefits between Nissen and other fundoplication     techniques in children are still uncertain.      The aim of our study was to compare the long-term outcomes following laparoscopic Nissen     fundoplication with laparoscopic Thal fundoplication in children.   "
242431|NCT01027988|"     Earlier studies have found that retinal photography could be very useful for evaluating the     condition of microcirculation and the risk of cardiovascular diseases in patients. The     architectural changes in retinal vascularisation strongly correlates with macrovascular     remodeling. Also, recent founding suggests a possible close anatomical parallel between both     the macrovascular and the microvascular blood.      Our objectives are to assess (1) in which age and sex subgroups, if any, retinal vascular     alteration in arterioles and venules can be predictive for cardiovascular morbidity and     mortality; and (2) whether variations in arteriolar or venular caliber will predict better     cardiovascular pathogenesis in normal and patient population. If the association between the     diameter of the retinal vessels and the risks of cardiovascular disease is verified during     this study, the impact on prevention would be enormous. The retinal microvascular change     could become a powerful biomarker in the early detection of the cardiovascular pathogenesis     and death risk   "
242432|NCT01028014|"     Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions     of American women. Women may develop these problems because the innervation of the muscles of     the bladder and urethra are injured. Most research on treating these problems has focused on     the abnormalities of the bladder muscle, but newer studies have shown abnormalities in the     innervation and muscle function of the urethra.      Women with these symptoms may benefit from treatment with medications to improve their     urethral function. However, to truly understand what types of medications will help women     with these symptoms, the investigators wish to study how these medications affect innervation     and muscle function in healthy women who do not have lower urinary tract symptoms.   "
242433|NCT01028027|"     This study is to evaluate the safety and efficacy of loteprednol etabonate [LE] and     tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in     the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).   "
242436|NCT01028066|"     The simple knowledge that practices healthy lifestyle are important to reduce or prevent the     progression of cardiovascular diseases it is not enough for effective changes accordingly. To     nutritional education be successful, needs to promote changes in eating habits and not just     transmit information. This is a behavioral intervention study in 200 consecutive patients     submitted to percutaneous transluminary coronary angioplasty. The participants were     randomized in two groups: intervention and control.      The intervention was a dialogic nutritional counseling and the control arm was a traditional     nutritional counseling.      All participants will undergo long-term follow-up for cardiovascular events.   "
242437|NCT01028079|"     The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (the     study medication) by comparing it to placebo (the control group without active substance) or     400 mg Ibuprofen (the control group with an active substance) in treating the symptoms of     back pain. The study is designed to develop a treatment method against back pain which will     have more advantages for patients than the methods that are currently available.   "
242438|NCT01028092|"     This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then     everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for     elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old).   "
242439|NCT01028105|"     The purpose of this study is to evaluate the prevalence of pre-surgical patients who are MRSA     carriers. From an evidence-based practice perspective, findings from this study can be     considered in the evaluation of the hospital SOP mandating pre-surgical MRSA screening     requirements for patients with scheduled surgeries.      The central hypothesis to be addressed in this study is whether the MRSA colonization and     subsequent post-operative infection are the equivalent in these populations.   "
242440|NCT01028118|"     Objective- Analysis of the health status of women who were or are victims of domestic and     sexual violence seeking attention at the outpatient clinic for Endocrines Gynecology and     Climactery - University of Sao Paulo General Hospital.      To widen the comprehension of the binomial relationship violence-pathologies by     professionals/staff who work in health services, offering women in such situation humane,     comprehensive and qualified attention. Specific Objectives: decreasing the rates of domestic     and sexual violence against women employing: prevention, health education and treatment -     within the context of health services and public policies.      Methodology - Project Type: Research in Action A- Attention to women in a situation of     domestic and sexual violence during climactery; B- Information/Education/Communication (IEC)     C- Behavioral Intervention (IC) D- Institutional Development (DI). Target Populations: 1.     Women (during the ages of 40 to 65 years) who were or are victims of domestic and/or sexual     violence; 2. Professional/staff who work in services attending women in sexual and domestic     violent situations (health professionals, policemen, civil society) in areas located within     the South Regional Health Coordination - SRC. To collect information, a semi structured     questionnaire will be employed during seven months in 2009.   "
242441|NCT01028131|"     This study will develop:        1. Develop the computer-based brief intervention and Contingency Management (CM)          components, with repeated feedback from experts, prenatal clinic staff, and          participants.        2. Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women          to Brief Intervention, CM, combined, or control conditions.        3. Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported          smoking, breath carbon monoxide (CO), and urinary cotinine levels.        4. Collect data regarding birth outcomes and evaluate the feasibility of various methods of          post-partum follow-up.   "
242442|NCT01028144|"     The increasing prevalence of obesity in U.S. children and adolescents is a major health     threat to our society, especially among minority and low social economic status (SES)     populations. During adolescence physical activity (PA) decreases and is likely an important     contributor to the increasing trend in childhood obesity rates. Little evidence suggests that     school-based curriculum interventions lead to increases in overall PA. Thus, this proposal     will evaluate the efficacy of an innovative motivational and behavioral skills after-school     program for promoting increases PA among underserved adolescents (e.g., minorities, low SES).     The motivational plus behavioral skills intervention is consistent with Self-Determination     (Motivation) Theory and Social Cognitive Theory in that it emphasizes increasing intrinsic     motivation and behavioral skills for PA. Adolescents in the intervention take part in     developing the program, selecting physical activities that generate fun and interest, and     generating their own coping strategies for making effective PA changes during a videotaped     session. Preliminary data from our group demonstrates the feasibility of the motivational     plus behavioral skills PA program for increasing moderate-to-vigorous PA (MVPA) in     underserved adolescents in South Carolina. The proposed project will use a school-based     nested cohort design to evaluate efficacy of a 17-week motivational plus behavioral skills     program versus typical after-school program (general health education only) on increasing PA     in underserved adolescents. Twenty-four middle schools (70 6th graders per school; N=1,680),     located in South Carolina will be randomly assigned to one of two after-school programs. The     study employs a nested cohort design, with schools, rather than individuals assigned to     condition and will be analyzed using repeated measures analysis of covariance techniques as     outlined by Murray. We will also examine psychosocial variables (PA self-efficacy,     self-concept, motivation, social support, and enjoyment) as potential mediators of the     intervention on changes in MVPA using regression and structural equation modeling techniques.     This study will address an important public health problem that will have implications for     decreasing obesity in underserved adolescents.   "
242443|NCT01028157|"     STARS: Sistas Talking About Real Solutions is a health education intervention for     African-American women, ages 18-29 aimed at reducing their risk for HIV. A total of 855     subjects were recruited from three Kaiser Permanente Medical Centers. Members were randomly     selected from the membership database and sent a letter via mail introducing them to the     project and inviting them to participate. Letters were followed up with a phone call and     potential participants were screened for eligibility. To be able to participate, participants     had to be African-American, female, between the ages of 18-29, single, and have at least one     act of unprotected sexual intercourse within the last 6 months. Members who were eligible and     willing to participate completed a 1-hour baseline assessment survey; STD testing for     Chlamydia, gonorrhea, trichomoniasis, and HPV; a vaginal swab that was used to determine if     they had unprotected sex. They were then randomized into one of two study conditions: (1) a     2-session HIV risk-reduction condition with a safer sex relapse prevention component (2) a     1-session control condition in which participants receive general women's health information     and brochures. Participants received a booster session at 6 and 9 months to reinforce     intervention materials. Participants completed an assessment survey and received STD testing     at 6 and 12 months. The primary aim of this project is to evaluate the efficacy of the HIV     risk-reduction/safer sex relapse prevention condition relative to the health and nutritional     control group in reducing HIV-associated sexual behaviors and incident STDs over a 12-month     follow-up period is to implement.   "
242445|NCT01028183|"     The purpose of this research is to address the comparative effectiveness and harm of the     therapeutics frequently given to pregnant women and their young infants including     antibiotics, tocolytic agents, non-steroidal anti-inflammatory drugs, H2 blockers, and     steroids.      Our overall hypothesis is that the use of an existing electronic medical record with     additional resources for precise data collection and 18 month follow up will successfully     address current knowledge gaps in therapeutic effectiveness and relative therapeutic harm.      We will use an existing electronic medical record into which detailed healthcare information     is entered for over 100,000 newborns each year. These infants will comprise the Source     Cohort. Nested within that database, we will prospectively enroll 10% of the population     (10,000 newborns) as the Follow-Up Cohort.      The current electronic medical record for the Source Cohort does not capture therapeutic     dosing with sufficient precision to conduct comparative effectiveness research sufficient to     change medical practice. The proposed research will: 1) ensure accurate data collection     through electronic monitoring and real-time quality assurance evaluation in the Source     Cohort; and 2) conduct 18 months post-hospital follow-up for neurologic outcomes and     disability for the Follow-Up Cohort. We will complete assessments of neurologic outcomes and     disability using an interactive web-based system, mail, telephone follow up, and in-person     examination.   "
242446|NCT01028196|"     This study is aimed to evaluate the bipolar disorder symptoms in patients presented with     schizophrenia, schizoaffective disorder or recurrent depression.      Bipolar disorder is a group of mood disorders characterised by elevated or irritable mood     episodes in patient's lifetime history accompanied by some additional symptoms. In this study     modern bipolar disorders screening/assessment instruments will be used to explore the     prevalence of bipolarity symptoms in patients who never been diagnosed with bipolar     disorders. The results of this study could be useful for more accurate assessment of bipolar     disorders prevalence in psychiatric patient population, could help to improve the diagnostics     of bipolar disorders and management of bipolar patients.   "
242447|NCT01028209|"     The underlying goal of this study is to assess [18F] PBR06 PET imaging as a tool to detect     microglial activation in the brain of Alzheimer Disease (AD), Parkinson Disease (PD) and     Multiple Sclerosis (MS) research participants.   "
242448|NCT01028222|"     The purpose of this study is to determine whether nilotinib is efficacious in the treatment     of metastatic and/or inoperable melanoma harboring a c-Kit mutation.   "
242449|NCT01028235|"     The purpose of this study is to identify the prevalence of pathologic eosinophilic     esophagitis (EoE) in the cohort of adult patients who present for specialty care in the     gastroenterology clinics with complaint of difficulty swallowing (dysphagia). From this, the     investigators will make recommendations regarding routine screening for the diagnosis in this     cohort. The prevalence of EoE in patients presenting for specialty care in the     gastroenterology clinics with the complaint of dysphagia is great enough that the diagnosis     should be routinely screened against in this cohort.   "
242450|NCT01028248|"     The purpose of this study is to determine whether ranibizumab (Lucentis) will be effective in     reducing if not eliminating the macular edema associated with the disease, central retinal     vein occlusion (CRVO).   "
242451|NCT01028261|"     The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well     tolerated in obese female subjects. The study will also provide information on how much     ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other     biological markers.   "
242452|NCT01028274|"     The purpose of this study is to assess the safety and efficacy of a natural health product     among participants with elevated LDL cholesterol and triglyceride levels.   "
242453|NCT01028287|"     This is a prospective open labeled trial examining the efficacy of ACTHar Gel (porcine ACTH)     on the level of proteinuria in patients with diabetic nephropathy and nephrotic range     proteinuria.   "
242454|NCT01028300|"     Degenerative disc disease (DDD) refers to a syndrome in which a degenerating disc causes     chronic back pain, significantly impacting an individual's ability to function. The condition     is most commonly diagnosed in the lumbosacral spinal segments L3-S1. The condition often     starts with an injury to the disc space. The injury weakens the disc and creates excessive     motion at the corresponding vertebral level. Over time, the segmental instability and     associated neurological compromise combined with ongoing inflammatory processes that occur in     and around the disc produce low back pain. The reparative processes in the disc are poor,     thus the painful symptoms can become chronic.      Premature degeneration at adjacent levels of the spine remains one of the more vexing     problems facing spinal surgeons when advising relatively young people to consider lumbar     fusion surgery. Stopping the motion changes the mechanics of the back (which is designed for     motion and flexibility) and results in the transfer of the loads and stresses to the adjacent     vertebral segments. It is therefore intuitive to pursue total disc replacement, which allows     for the treatment of pain due to DDD while re-establishing motion and stability, load     distribution, and restoring the disc height, as an alternative to spinal fusion surgery.      The study hypothesis is that military personnel receiving Total Disc Replacement will return     to the same level of active duty performance as at the time of their most recent successful     physical readiness test.   "
242455|NCT01028313|"     There is a clear need for effective, steroid-sparing agents for the management of chronic     graft-versus-host disease (GVHD). Thus, agents like Histone deacetylase (HDAC) inhibitors,     with the potential of decreasing pro-inflammatory events leading to GVHD without affecting     graft-versus-leukemia (GVL), may have a central role in the prevention and treatment of GVHD.      This study will look at the efficacy of panobinostat (LBH589), an HDAC inhibitor, in the     treatment of patients with chronic GVHD who have failed corticosteroids. In this group of     patients, effective steroid-sparing options are limited and are usually associated with     profound immunosuppression and decreased GVL effect.   "
242495|NCT01028833|"     The purpose this study is to determine the effects of power mobility on the development and     function of young children of young children whose severe physical disabilities limit their     exploratory behaviors and may unnecessarily restrict their cognitive, communication, and     social-emotional development.   "
242496|NCT01028846|"     The purpose of this study is to understand how diazoxide, a medication that has been shown to     have effects on insulin and other hormone secretion, can regulate the production of sugar by     the liver.   "
242456|NCT01028326|"     The World Health Organization has recommended that developing countries should incorporate     pneumococcal conjugate vaccine (PCV) into their routine immunization schedules. The Kenya     Ministry of Health anticipates introducing a new formulation of PCV, PCV10, into the routine     childhood immunization schedule in 2010. In the areas of Kenya that have been designated to     monitor the impact of vaccine, a catch-up campaign will be implemented to vaccinate children     aged 12-59 months. PCV10 has been found to be safe and effective in infants. It is licensed     for use in children up to 2 years of age, but its use as a primary series in children over     age 12 months has not been evaluated. This study will assess the immunogenicity and     reactogenicity of PCV10 first administered at an age of 12-59 months.   "
242457|NCT01028339|"     The purpose of this study is to determine whether hypertonic saline is as much effective as     mannitol to treat intracranial hypertension after traumatic brain injury and has at least the     same effects on PtiO2 and cerebral metabolism studied through microdialysis.   "
242458|NCT01028352|"     Many women with breast cancer who are treated with aromatase inhibitor medications develop     aches and pains during treatment, and some develop numbness and tingling in their hands and     feet. Some examples of aromatase inhibitor medications include anastrozole (Arimidex),     exemestane (Aromasin), and letrozole (Femara). Frequently, pain medications do not work very     well to relieve the pain. Duloxetine (Cymbalta) is a medication that was originally developed     to treat depression. It has also been found to relieve pain that occurs in people with     diabetes, fibromyalgia, arthritis, and other painful conditions. In this study we are testing     to see if duloxetine will help treat the pain that can occur in women treated with aromatase     inhibitors.   "
242459|NCT01028365|"     The purpose of this research study is to learn a way to measure a person's fertility. After 1     year of trying, 1 out of every 7 women will not be pregnant. This is called infertility. This     results in significant distress and anxiety. Infertility is common; however, the     investigators have no markers to predict who will be infertile. For couples diagnosed with     infertility, the investigators have used blood and urine hormone levels (follicle stimulating     hormone (FSH), inhibin B, and antimullerian hormone (AMH)) to tell us who will get pregnant     with fertility treatment. The investigators don't know if these hormone levels can predict if     regular people trying to get pregnant will be able to get pregnant. This study will try to     determine if these hormone levels can predict fertility and infertility.   "
242460|NCT01028378|"     This purpose of this study is to evaluate the safety and effectiveness of a topography-based     custom ablation treatment using the ALLEGRETTO WAVE® Eye-Q 400 Hz laser system for treating     myopia and hyperopia.   "
242461|NCT01028391|"     A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting     plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in     patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.   "
242462|NCT01028404|"     This trial is conducted in Europe. The aim of this trial is to investigate the safety,     tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as     tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.      The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or     insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2     diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and     placebo.   "
242463|NCT01028417|"     LAY ABSTRACT        1. Statement of the health problem or issue: Of the estimated 24,000 Canadians who will be          diagnosed with lung cancer in 2008, 21,000 will die of their disease. Based on this          cancer incidence and survival data, the most promising current strategy for improving          outcome is screening and early detection. It is suggested that if lesions are discovered          at an earlier stage of disease, they will have a higher likelihood of being treatable          and therefore, survival will be improved. CT detection of growing small lung nodules,          many of which are non-cancerous (benign), raises the possibility of lung cancer and thus          causes anxiety in patients and referring clinicians. Unfortunately, confident separation          of benign from malignant small lung nodules cannot be reliably achieved using CT or PET          criteria. Pathologic diagnosis using needle or excision biopsy is usually required.           Excision biopsy removes the entire nodule at one setting and eliminates the sampling          error associated with needle biopsy, making it appealing to physicians and patients. To          reduce post-operative pain and breathing difficulties, excision biopsy is often          performed using minimally invasive surgery (video assisted thoracoscopic surgery, VATS).          Finding small pulmonary nodules is often difficult with the minimally invasive camera          (VATS) and a bigger incision (thoracotomy) is necessary in more than 60% of our          patients.           We recently developed a technique of using platinum micro-coils, which are inserted in          the lung nodule using CT guidance, to locate the nodule with fluoroscopy and then excise          it with VATS. We have completed a pilot study (n=75 nodules; 69 patients) to determine          the effectiveness of this technique. Seventy three (97%) 4-24-mm nodules were          successfully removed at fluoroscopically guided VATS excision.        2. Objective of your project: To improve our ability to successfully excise small growing          lung nodules with minimally invasive VATS surgery using CT guided micro-coil          localization techniques.        3. How will you undertake your work? We propose to conduct a randomized controlled trial to          determine if the use of CT guided platinum microcoil markers for VATS excision of          subcentimetre pulmonary nodules can reduce the rate of conversion to open thoracotomy          from 50% to 10%.        4. What is unique/innovative about your project? New image guided minimally invasive          surgical technique for removing early growing cancers was developed at the Vancouver          General Hospital and the University of British Columbia. This has been published in          peer-reviewed journals and can potentially allow us to accurately locate and excise          suspicious lung nodules        5. Relevance to Lung Association's mission statement? Lung cancer remains a major health          problem in Canada. Early detection and screening programs allow for discovery of nodules          when they are still very small and therefore, likely curable. Excision biopsy removes          the entire nodule at one setting and eliminates the sampling error associated with          needle biopsy, making it appealing to patients and physicians. To reduce post operative          morbidity, costs and volume of lung removed, excision biopsy is often performed using          video assisted thoracoscopic surgery (VATS) techniques. Using a pilot project grant from          the BC Lung Association we have developed a new technique that allows preoperative CT          marking of the nodule and minimally invasive removal of the lesion. We hope that this          technique will allow earlier treatment of lung cancers and improve survival in this          devastating disease.   "
242464|NCT01028430|"     B-CLL is the most prevalent leukemia in the Western hemisphere, accounting for ~25% of all     leukemia's (1). This disease occurs virtually exclusively in the aging population, with the     median age of diagnosis ranging between the mid 60s and the early 70s. Indeed, its occurrence     before the age of 50 is quite unusual. This increase in occurrence with age is not unique to     B-CLL; rather, it is characteristic several B cell lymphoproliferative disorders (e.g.,     non-Hodgkin's lymphoma, multiple myeloma). Gender and race also influence the development of     B-CLL. Thus, the ratio of men: women is ~2:1 and the prevalence is increased in Caucasians.     The rate of occurrence of B-CLL among Asians is significantly lower than for Caucasians and     this does not increase with immigration to the West. DNA sequence analyses performed in our     laboratory and in those of others indicate that B-CLL cells from unrelated patients share Ig     V gene characteristics. These include the use of selected genes, the association of these     genes with certain D and JH gene segments that code for unique CDR3 motifs, and the     occasional occurrence of highly similar VHDJH + VLJL pairs. In ~50% cases, these rearranged     genes are mutated, whereas in the others mutations are infrequent; this difference is related     to the VH gene family used by the B-CLL cell.   "
242465|NCT01028443|"     The use of topical Cyclosporine A early after an episode of endothelial graft rejection after     penetrating keratoplasty and continuing its administration for 6 months can reduce the course     of that episode and recurrence of the rejection.   "
242466|NCT01028456|"     This study is designed to investigate whether light therapy may be an effective treatment for     some people with epilepsy. Light treatment is already an established treatment for     depression. The chemical systems in the brain that are disrupted when someone becomes     depressed, overlap with some of those that can be affected during some epileptic seizures.     The investigators have designed this study to see whether light therapy may also lead to a     decrease in seizures in people who have epilepsy.      The study will be a placebo controlled trial. This means that half of the participants will     receive a therapeutic dose of light therapy from a light box, whilst the other half will only     receive a placebo light treatment.   "
242467|NCT01028469|"     The aim of this prospective, case series is to evaluate the surgical treatment of painful and     disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer.   "
242483|NCT01028677|"     Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves     social cognition, social functioning and decreases paranoia and other psychotic symptoms in     schizophrenia.      Participants: Up to 80 adults with schizophrenia for at least one year and with a high rating     for paranoia.      Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal     spray (6 insufflations/dose or 24 IU) for 6 weeks. Before, during and at the end of the     trial, each subject will undergo social cognitive measures (primary outcomes) and psychiatric     symptom ratings (secondary outcomes).   "
242468|NCT01028482|"     Introduction:      Postpartum depression (PPD) occurs in large numbers of women (between 10 - 20%) and     substantially affects both their own well-being and their offspring's mental and emotional     development. Whereas PPD is a form of major depression, its etiology is probably related to a     combination of biological (hereditary, hormonal etc.), and psychological factors. In     practice, most women suffering from PPD do not seek treatment, or are treated with     psychotherapy alone due to concerns regarding pharmacotherapy. This is despite the obvious     importance of reaching a rapid remission in these women. In fact, data regarding the     treatment of PPD with antidepressants is surprisingly sparse and is limited to only one     blinded and placebo-controlled study (with fluoxetine) and a number of studies without a     placebo arm . The reason for the paucity of double-blinded placebo-controlled studies is     probably due to 3 main limiting factors: Firstly, the reluctance of women to admit to and     seek professional help due to depression, Secondly, the difficulty to administer     antidepressant medication to lactating women, and, Thirdly, the ethical difficulties in     designing a study with a real placebo group.      In contrast to the very limited number of drug studies in this population, there are a number     of studies that have shown the efficacy of psychotherapy in the treatment of PPD. Positive     studies have been published using different types of psychotherapy, including cognitive,     dynamic and interpersonal psychotherapy.      The investigators propose to study the efficacy of psychotherapeutic treatment in women     suffering from PPD with add-on sertraline in a randomized double-blind, placebo-controlled     design. To overcome the difficulties described above in studying antidepressants in the     postpartum period, the investigators propose to include active brief dynamic psychotherapy     for all women. Furthermore, the investigators will selectively allow inclusion of women who     only suffer from either mild or moderate major PPD (not severe / suicidal) .      Hypothesis:      The investigators hypothesize that women with PPD randomized to the arm receiving     psychotherapy + active sertraline will show a greater response rate than the psychotherapy +     placebo group. Furthermore, the investigators hypothesize that the difference in response     between the 2 groups will demonstrate a significant early response in the active sertraline     group.   "
242469|NCT01028495|"     To assess the safety and efficacy of a combined therapy regimen of RX-0201 plus Gemcitabine,     in subjects with metastatic pancreatic cancer.   "
242470|NCT01028508|"     This study will determine whether medications alone or medications and electroconvulsive     therapy (ECT) work best to prevent depressive relapse and to improve quality of life for     older people with severe mood disorders.   "
242471|NCT01028521|"     A first time in man, phase I study to assess the safety, tolerability and pharmacokinetics of     single ascending doses of CM3.1-AC100 in healthy male volunteers.   "
242472|NCT01028534|"     The aim of the present study is to compare the effects of different types of antihypertensive     drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients     with hypertension and obstructive sleep apnea who are not controlled well with their     hypertension after continuous positive airway pressure therapy.   "
242473|NCT01028547|"     This is a randomised controlled double blinded clinical trial to determine the antiemetic     efficacy and safety of either 8 mg of dexamethasone or normal saline (placebo) given 1 hour     before induction of either spinal or general anaesthesia in 2 arms (of 150 each).   "
242474|NCT01028560|"     In this clinical study we aim to determine the effect of allergy immunotherapy in decreasing     asthma and allergy related disease in children who had multiple episodes of wheezing and who     are at high risk for developing persisting asthma. These risks include a history of asthma in     the parents, allergies to environmental allergens (such as dust mite, cockroach or mouse) and     other allergic diseases such as eczema or food allergies. Allergy Immunotherapy is not new     and has been practiced for many years to treat asthma and environmental allergies in older     children and adults, but has not yet been systematically studied in young children.   "
242475|NCT01028573|"     The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon     before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel     preparation solution. Another purpose is to see if taking half of the bowel preparation     solution on the evening before the colonoscopy and half on the morning of the colonoscopy     will result in a cleaner colon than taking all of the bowel preparation solution on the     evening before.   "
242476|NCT01028586|"     Parkinson's disease is a major neurodegenerative disorder in which there is a progressive     loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of     dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a     precursor of DA that crosses the blood brain barrier, and also to the use of selective     inhibitors of MAO B, the major DA metabolising enzyme in man.      This is a double-blind, placebo-controlled, extension trial, parallel-group, randomised,     multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100     mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine     agonist in subjects with early idiopathic Parkinson's Disease.      The principal objective is to evaluate the time to first intervention, as some previous data     suggested that safinamide may delay the need for further dopaminergic supplementation.   "
242477|NCT01028599|"     The purpose of this study is to investigate the effect of physical training on work capacity     and vascular function after heart transplantation, cardiac transplant recipients are     randomized to 8 weeks of intense physical training or control. Vascular function is measured     non-invasively. Effect on the hormones and the immune system is evaluated using blood     samples.   "
242478|NCT01028612|"     The main objective of this study is to assess the initial safety of the combination of     interventional ablation and external beam radiotherapy including acute and late toxicity (90     days) for patients with early stage lung cancer.   "
242479|NCT01028625|"     The purpose of the study is to test whether Cognitive Behavior Therapy (CBT) plus heart     failure self-care education is superior to usual care for depression.   "
242480|NCT01028638|"     Everolimus indirectly inhibits angiogenesis by reducing VEGF production. VEGF can be     non-invasively visualized and quantified with serial 89Zr-bevacizumab PET imaging in     patients.      The investigators hypothesize that a decline in VEGF early during everolimus treatment in     patients with metastatic renal cell carcinoma predicts treatment efficacy.      89Zr-bevacizumab PET scans will be performed at baseline, after 2 and 6 weeks of everolimus     treatment in 14 adult patients with metastatic renal cell carcinoma.   "
242481|NCT01028651|"     This was a multicenter, prospective, observational, open-label study. Patients meeting     inclusion/exclusion criteria received treatment with treprostinil as recommended by their     treating physicians and were followed according to standard of care. This observational study     collected clinical data and biologic specimens from patients who were treated for     portopulmonary hypertension (PoPH), with a goal of achieving hemodynamic parameters     appropriate for orthotopic liver transplantation candidacy, including mean pulmonary arterial     pressure (mPAP) less than 35 mmHg and pulmonary vascular resistance (PVR) less than 3     Wood-units (WU) at Week 24 in patients with severe PoPH.   "
242482|NCT01028664|"     A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure     (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to     detect the induced IOP reduction.   "
242484|NCT01028690|"     Helicobacter pylori colonizes approximately to 50% of the world-wide population.      There is an exigency to find routes alternating to control the infection with an ample     perspective but without the complications of induction of resistance to antibiotics.     Supplement dietetic with Lactobacillus reuteri (L. reuteri) in humans takes to the     colonization of epithelium gastric and this, combined with the observation of which L.     reuteri has the capacity to inhibit the growth of H. Pylori and its union to the gastric     mucosa, indicates the potential that the native human bacteria control and influence in the     colonization in humans.      The acid-lactic bacteria (in particular the lactobacillus) have been studied by their effects     in humans infected with H. Pylori with some success to reduce the load of bacteria Studies     using supplements with L. reuteri as much in infected symptomatic patients as asymptomatic     with H. pylori showed a clear reduction of the load of bacteria after 4 weeks of use and this     was concordant with a reduction in the symptoms associated to the infection.   "
242485|NCT01028703|"     Studies of patients with established kidney disease, even when this is mild, appear to show     that they are at high risk of heart failure, stroke and sudden cardiac death. This may be     because kidney disease causes stiffening of the arteries in the body which means that the     heart and brain are damaged by high blood pressure. By studying patients before and after the     removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for     the first time in man the effect of an isolated reduction in kidney function on the structure     and function of the arteries and heart.      Hypotheses. An isolated reduction in GFR occuring after surgical uni-nephrectomy is     associated with long term adverse cardiac and vascular effects which include:        1. Increased arterial stiffness and left ventricular mass        2. Abnormalities in left ventricular systolic and diastolic function        3. Increased oxidative stress, inflammation and collagen turnover   "
242486|NCT01028716|"     This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works     in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus     and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host     disease (GVHD) in most patients with hematologic malignancies undergoing transplantation of     bone marrow from half-matched (haploidentical) donors. This approach has extended the     transplant option to patients who do not have matched related or unrelated donors, especially     for patients from ethnic minority groups. The graft contains cells of the donor's immune     system which potentially can recognize and destroy the patient's cancer cells     (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune     system is prevented by giving low doses of chemotherapy (fludarabine phosphate and     cyclophosphamide) and total-body irradiation before transplant. Patients can experience low     blood cell counts after transplant. Using stem cells and immune cells collected from the     donor's circulating blood may result in quicker recovery of blood counts and may be more     effective in treating the patient's disease than using bone marrow.   "
242487|NCT01028729|"     This single arm study will assess the safety and efficacy of Endostar combined with     chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance     therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).   "
242488|NCT01028742|"     The purpose of the study is to estimate the incidence of posttraumatic hypopituitarism, and     to identify predisposing factors in order to establish a rational responsible socioeconomic     screening program.   "
242489|NCT01028755|"     This is the first time this drug will be tested in humans in order to determine the safety of     the drug, the ability to tolerate the drug, to measure how the drug is used in the body and     as a result of these tests to determine a maximum dose to be given. Specifically, the     following aspects will be investigated:        -  side effects of BAY79-4620 given as infusion every three weeks        -  evaluation of highest and safest dose of BAY79-4620        -  distribution and concentration of BAY79-4620 in the blood at specific times after          administration        -  effect of BAY79-4620 on tumor growth        -  assessment of biomarkers (eg, analysis of specific proteins in blood samples, or          analysis of tumor tissue sampled at the time of cancer diagnosis) for changes during the          treatment or prediction of safety or benefits of the treatment with BAY79-4620.   "
242490|NCT01028768|"     To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide     following subcutaneous (SC) administration of 10 mg teduglutide.      Secondary objectives are to assess the safety and tolerability of 10 mg teduglutide. A     further objective is the description of the PK of teduglutide following SC administration of     10 mg teduglutide in elderly (≥ 65 years) healthy subjects compared to non elderly healthy     subjects.   "
242491|NCT01028781|"     Patients will undergo a standard history and physical examination detailing objective     clinical exam findings performed by one of the co-investigators. The research coordinator     will obtain baseline values for intensity of pain, quality of life, and coping strategies.     Baseline serum levels inflammatory markers will then be measured. Over the course of 12 weeks     Thalidomide will be titrated as tolerated to achieve a minimum of a 30% reduction of pain on     VAS from week 2.   "
242492|NCT01028794|"     The purpose of this study is to determine whether autologous bone marrow mononuclear cells     transplantation after stroke is safe and/or effective to improve neurological outcome.   "
242493|NCT01028807|"     Purpose:      To determine the safety and efficacy of early enteral feeding after distal (ileum-colon)     elective bowel anastomoses in children.      Methods:      Controlled randomized trial including all pediatric patients with distal elective bowel     anastomosis, excluding non-elective and high risk patients. VARIABLES:      Demographic characteristics, operative time, anastomosis placement,      Follow up: Tolerability variables: beginning peristalsis, beginning bowel movement, time to     full diet intake, post-operative stay. Safety variables: mild and persistent vomiting,     persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or     dehiscence, reoperation and death. At the end of surgery were randomized to:        1. Experimental group(EG): Early feeding group, after a 24 hours fasting period, with good          abdominal conditions (once the post operative ileus had solved), oral fluids and diet          was started.        2. Control group (CG): obligatory 5-day fasting. Once the regular diet was tolerated, the          patients were discharged. Statistics: Descriptive statistics for global description.          Student's t test for quantitative variables and Chi square test for qualitative          variables, a p-value less than 0.05 was considered statistically significant.   "
242497|NCT01028859|"     A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting     toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection     on a weekly schedule in patients with advanced solid cancers failed to standard therapy. The     usefulness of the this regimen is evaluated by response rate, progression free survival and     vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI).   "
242498|NCT01028872|"     Aspheric intraocular lenses can effectively reduce higher-order aberrations and improve     contrast sensitivity function after cataract surgery.   "
242499|NCT01028885|"     This is a prospective clinical trial examining the use of MRI to measure internal organ     motion and any resulting changes in the target volume (shape and location) during a course of     post-operative radiation therapy for prostate cancer. The goal is to better understand and     characterize these physiologic variations so that they can be accounted for during the     treatment planning process. The ultimate longer-term clinical goal here is to provide a form     of adaptive radiation therapy in the future, such that if major changes are seen over an     8-week course of radiation therapy in our study. This may argue for hypofractionating those     patients who are most likely to have major shifts over time.   "
242500|NCT01028898|"     In the investigators study, the investigators will focus on the screening of the related     proteins and miRNA to IBS in order to reveal the possible clues or molecular mechanism for     this disorder.   "
242501|NCT01028911|"     This is a study to evaluate the safety, tolerability and blood levels of PF-03654746 in     subjects will mild to moderate Alzheimer's disease.   "
242502|NCT01028924|"     The primary objective of this trial is to investigate if teduglutide has an effect on cardiac     repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible     effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration),     pharmacokinetics and safety and tolerability in healthy subjects, and to determine the effect     of the positive control, moxifloxacin, for sensitivity analysis. The trial will consist of a     screening and a treatment phase of four treatment periods. There is a washout period of at     least 7 days and 4 weeks at maximum between administrations. The expected total trial     duration for the individual subject will be about 7 weeks (maximum 17) weeks.   "
242503|NCT01028937|"     The purpose of this U.S. Clinical Trial on treatment of sighted eyes is to investigate the     safety and effectiveness of optimal keratoplasty (Opti-K™) treatments for hyperopia     correction using the NTK Enterprises (NTK) Opti-K System.   "
242504|NCT01028950|"     To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous     thromboembolism (VTE) in patients with acute medical illness.   "
242505|NCT01028963|"     The purpose of this study is to evaluate the safety and potential effectiveness of CCX140-B     in subjects with Type 2 diabetes mellitus.   "
242506|NCT01028976|"     The purpose of this study is to determine whether or not Vitamin C (1000 mg/day) can reduce     markers of inflammation, especially C-reactive protein (CRP), in obese persons with baseline     CRP greater than 1 mg/dl.   "
242507|NCT01028989|"     Polycystic ovary syndrome (PCOS) affects 5-10% of women of reproductive age, and is     associated with infertility, risk for obesity and type 2 diabetes, and impaired quality of     life. The elevated insulin characteristic of PCOS is likely to play a major role in its     symptoms. Manipulation of dietary carbohydrate quantity and quality (glycemic load; GL) may     lower insulin and improve both reproductive and metabolic outcomes. The purpose of this study     is to determine if a lower GL diet intervention is more effective than a standard (STD) diet     in improving reproductive and metabolic outcomes of women with PCOS in the absence of weight     loss.   "
242508|NCT01029002|"     A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney     Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney     damage.   "
242509|NCT01029015|"     This is an observational, physiology pilot study of subjects with overactive bladder,     insomnia and normal subjects. No study drug will be given. All subjects will complete a one     week sleep diary and a 3-day bladder diary. After one week, subjects meeting eligibility     requirements will complete a single sleep night stay in a sleep laboratory setting. During     the sleep night stay, subjects will be evaluated using cystometry and polysomnography. In the     morning following the sleep night stay, subjects will complete a sleep questionnaire and this     will complete their participation in the study.   "
242528|NCT01029275|"     The aim of the study is to evaluate the interest of a six month pre-operative treatment with     a long-acting somatostatin analog (Sandostatin LP) versus surgery alone in patients with a     pituitary adenoma responsible for acromegaly.   "
242529|NCT01029288|"     The proposed trial seeks to determine the impact of patient decision aids versus usual care     on measures of patient involvement in decision-making, diabetes care processes, medication     adherence, glycemic and cardiovascular risk factor control, and resource utilization in     nonurban practices in the Midwestern United States. Upon completion of this trial, the     investigators will have new knowledge about both the effectiveness of diabetes decision aids     in nonacademic nonurban practices and about the processes that promote or inhibit the     successful implementation of patient decision aids in such practices.   "
242802|NCT01033773|"     To demonstrate that a focused Emergency Department (ED) intervention for uncontrolled     hyperglycemia enables safe and effective glycemic management and reduces emergency room     re-visits. We assessed hypoglycemia BG < 60mg/dL; change in mean blood glucose and A1C, and     ED revisits for hyperglycemia.   "
242530|NCT01029301|"     Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis     and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin     dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to collagen     modification, skin laxity and cellulite (dermis and hypodermis).      EndyMed has developed the EndyMed Pro system - Computerized Radiofrequency System for Skin     Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern     can be produced allowing to selectively heating one or more of the target tissues (epidermis,     dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be     targeted, creating enough thermal effect to induce collagen remodeling with no ablative     thermal damage in the epidermis or dermis. This post marketing study is intended for     evaluation of safety and efficacy of the EndyMed Pro system.   "
242510|NCT01029041|"     Fibromyalgia is a rheumatologic syndrome characterized by widespread chronic pain, tender     points and other symptoms as fatigue, sleep disturbances, anxiety and depression. Therapeutic     exercises are described as an important form to management of symptoms. This study aims to     assess strengthening and stretching exercise efficacy in symptoms and quality of life of     Fibromyalgia patients. The study is done at General Clinical Hospital of Medicine Scholl of     University of Sao Paulo. 63 subjects undergo the study and they are divided into three     groups: 1 strengthening exercise, 2 stretching exercise and 3 control group. Patients are     evaluated by following instruments: Fibromyalgia Impact Questionnaire, Medical Outcomes Study     36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire,     dolorimetry at tender points by a Fischer dolorimeter, finger-to-tip floor test for muscular     flexibility, dynamometer EMG System do Brasil for strength test of extension and flexion of     knees and elbows, time to get up and go test, functional reach test, sit-to-stand test.     Subjects of 1 strengthening exercise group undergo a global strengthening program and 2     stretching exercise group undergo a global stretching program. All programs have 12 weeks of     duration and physical therapy is twice a week. The control group does not do any intervention     during 12 weeks and after the second evaluation they enter the common program of physical     therapy. Data are being analyzed by descriptive and interferential statistics procedures.   "
242511|NCT01029054|"     This study is designed to evaluate the safety and to determine the maximum tolerated dose of     carfilzomib + lenalidomide in combination with dexamethasone in newly diagnosed Multiple     Myeloma patients who have not received treatment.   "
242512|NCT01029067|"     Over a period of 4 weeks, metacognitive training for schizophrenia patients (MCT), delivered     both in a group and individually, is compared to cognitive remediation (CogPack training).     Blind to treatment assignment, both groups are assessed before intervention and four weeks     later with the Positive and Negative Symptoms Scale (PANSS), the Psychosis Rating Scales     (PSYRATS) and cognitive tests. Delusion severity serves as the primary endpoint. It is     assumed that MCT will improve delusion severity to a greater extent than CR in the course of     4 weeks taking medication into account.   "
242513|NCT01029080|"     The aim of the study is to correlate the dynamic cerebrovascular autoregulation by patients     with sepsis with a sepsis-associated delirium.   "
242514|NCT01029093|"     Investigation of changes in gray and white matter during immoblisation after injury of the     right upper extremity via two MR Investigations of the brain at two different times.   "
242515|NCT01029106|"     This is a prospective, non-randomized, observational, multicentre (5 sites) study in which     subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR     operative procedure.      The study will collect preoperative urologic testing, medical history, and subject quality of     life patient questionnaires, Intraoperative procedural data will be collected.      Postoperative complications, urologic, testing, and subject questionnaires will be collected     at intervals up to 24 months. The anatomic position of the device will be characterize by     transvaginal ultrasound testing.      To determine the rate and/or improvement rate of patients who have received the Gynecare     Secur device after 12 months and after 24 months.   "
242516|NCT01029119|"     Blood pressure meter model CH-101 was to be assessed against the standard mercury     sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.   "
242517|NCT01029132|"     To investigate the characteristics of treatment responders to galantamine.   "
242518|NCT01029145|"     The primary purpose of the study is to explore management of symptomatology in patients with     bipolar disorder that experience a new manic,depressive or mixed episode and are treated with     Seroquel XR monotherapy/adjuctive, in routine clinical practice in Romania   "
242519|NCT01029158|"     RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in     pre-clinical studies in animals, has shown comparable scar improvement efficacy to the     standard twice-dosed Juvista formulation. The aim of this trial is to investigate the     efficacy of RN1006 compared to Juvista in a human volunteer model   "
242520|NCT01029171|"     This study will be a randomized controlled trial to determine the efficacy of the Otago     Exercise Program (OEP) on falls among seniors with a history of falls.   "
242521|NCT01029184|"     In this study, non allergenic cereals will be tested in infants with atopic symptoms. The     test will be performed in a hospital.   "
242522|NCT01029197|"     Purpose: To conduct a pilot study of a cognitive-behavioral treatment (CBT) for PTSD and     substance abuse among persons with serious mental illness (SMI) treated in a community     setting.      Participants: Participants will be 50 volunteer adult individuals with PTSD and substance use     disorders (SUD), and SMI who are receiving services at the Freedom House Recovery Center,     served through the Orange Person Chatham (OPC) Area Program.      Procedures (methods): Participants will be randomly assigned to one of two conditions: 1) the     CBT intervention plus treatment as usual; or, 2) treatment as usual.   "
242523|NCT01029210|"     Increased life expectancy has attracted research attention, interested in provide a quality     and healthy aging. According to the latest census conducted in 2010 by IBGE, Brazilian     population consists of 97,342,162 women, whom estimates 30 million are between 40 and 65     years old, a period that includes the climacteric. Therefore, clinical conditions such as     osteoporosis becomes significant, either from public health policy standpoint or in relation     to the social aspect, by compromising life quality. Women also suffer more from     temporomandibular disorders (TMD) than men, and the beginning of this situation occurs after     puberty, with peaks during the reproductive and remission periods after menopause. Female sex     hormones involvement in osteoporosis is well established, but their participation in the TMD     is still controversial. Thus, this study aims to investigate the role of systemic bone mass     in menopausal women as a risk factor for articular TMD, as well as the TMD pain behavior     during menopause transition periods (48 to 55 years), postmenopausal (56-65 years) and     senescence (65-70 years). Therefore, 100 women attended by the HC - FMUSP Gynecology     Division, Climacteric Sector, were clinically evaluated by the Research Diagnostic Criteria     for Temporomandibular Disorders (RDC/TMD), used to obtain diagnoses and their associations,     as well as to quantify the TMD pain sensitivity degree through the Craniomandibular Index     (CMI), both applied by a single examiner. The bone densitometry provided bone mass data of     femoral neck and lumbar spine (L1-L4). The RDC/TMD performance as a diagnostic test also was     subjected to analysis, considering the 3.0 Tesla magnetic resonance imaging as reference     standard, undergoing 30 women, of 100 assessed, in this imaging exam. After analyzing the     results, it was shown that the risk posed by osteopenia was 1.33 (IC95% 1.20 - 1.46), with a     risk increase of 0.33, while the risk of osteoporosis showed 1.39 (IC95% 1,20 - 1.23 to     1.55), increased by 0.39. Joint diagnoses predominated (68.0%), while 18.0% muscular     diagnoses and 14.0% corresponds to the absence of clinically diagnosable conditions,     according to the RDC/TMD. The performance of the RDC/TMD to diagnose articular DTM revealed     accuracy of 68.0%, sensitivity of 83.0%, specificity 53.0%, pre-test probability of 52.0%,     positive predictive value of 60.0 % and negative 74.0%, positive likelihood ratio of 1.77 and     negative 0.32. As for the soreness sensibility in TMD, it was found that aging shows a clear     tendency towards its reduction (A =- 4.5, p = 0.0324). Then, the study concluded that the     decrease in female sex hormones, peculiar to aging, increases the risk of articular TMD,     although this pain disfunction decreases with age. The RDC/TMD can be used for large     populations screening, but its indication in clinical practice should be done with caution.   "
242524|NCT01029223|"     The purpose of this study is to determine the effect of slowing heart rate upon both central     and peripheral blood pressures using a medication called Ivabradine which slows heart rate     without affecting heart contraction, and to compare the effects of ivabradine to a     traditional blood pressure lowering medication called metoprolol (which is a beta-blocker).   "
242525|NCT01029236|"     The purpose of this study is to assess the effect of Metabolism-boosting Beverages (MBB)     containing green tea extract with a standardized amount of epigallocatechin gallate (EGCG)     and caffeine.   "
242526|NCT01029249|"     Oral human papillomavirus (HPV) and oral warts are common health concerns for HIV-infected     people. This study will examine the frequency of oral HPV DNA shedding and oral warts in     HIV-infected people who are enrolled in ACTG A5257 and who are beginning treatment with     highly active antiretroviral therapy (HAART).   "
242527|NCT01029262|"     The purpose of this study is to investigate whether lenalidomide would reduce the number of     red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants     with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study     also investigated the safety of lenalidomide use in these participants. Two-thirds of the     participants received oral lenalidomide and one-third of the participants received oral     placebo.   "
242531|NCT01029314|"     Primary study objective is to test the accuracy of the Genius 2 tympanic thermometer and the     Exergen TAT-5000(TM) temporal artery thermometer as compared with serial perioperative core     temperature measurements obtained in cardiac surgical patients during cardiopulmonary bypass.     Study hypothesis: The Genius 2 thermometer will display greater precision and accuracy than     the Exergen TAT-5000 thermometer when compared to core body temperature in patients     undergoing CABG surgery.   "
242532|NCT01029327|"     Previous animal studies have shown that extracts of Curcumin lowers blood glucose.   "
242533|NCT01029340|"     The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of     prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period     (split into two six month treatment periods). The study will compare 2 different methods     (assays) for measuring the amount of study drug, the chromogenic substrate assay per European     Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ).     During one six month period patients will receive the study drug where the dose has been     measured using the (CS/EP) and during the other six months period the dose will be measured     based on the Chromogenic Substrate Adjusted assay CS/ADJ)   "
242534|NCT01029353|"     This trial will compare the effectiveness of two surgical procedures -laparotomy versus     drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal     perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with     NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to     receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free     survival at 18-22 months corrected age.   "
242535|NCT01029366|"     This is a Pilot/Phase I, single arm, single center, open label study to determine the safety,     efficacy and cellular kinetics of CART19 (CTL019) in chemotherapy resistant or refractory     CD19+ leukemia and lymphoma subjects. The study consists of three Phases:      1) a Screening Phase, followed by 2) an Intervention/Treatment Phase consisting of apheresis,     lymphodepleting chemotherapy (determined by the Investigator and based on subject's disease     burden and histology, as well as on the prior chemotherapy history received), infusions of     CTL019, tumor collection by bone marrow aspiration or lymph node biopsy (optional, depending     on availability), and 3) a Follow-up Phase.      The suitability of subjects' T cells for CTL019 manufacturing was determined at study entry.      Subjects with adequate T cells were leukapheresed to obtain large numbers of peripheral blood     mononuclear cells for CTL019 manufacturing. The T cells were purified from the peripheral     blood mononuclear cells, transduced with TCR-ζ/4-1BB lentiviral vector, expanded in vitro and     then frozen for future administration. The number of subjects who had inadequate T cell     collections, expansion or manufacturing compared to the number of subjects who had T cells     successfully manufactured is a primary measure of feasibility of this study.      Unless contraindicated and medically not advisable based on previous chemotherapy, subjects     were given conditioning chemotherapy prior to CTL019 infusion. The chemotherapy was completed     1 to 4 days before the planned infusion of the first dose of CTL019.      Up to 20 evaluable subjects with CD19+ leukemia or lymphoma were planned to be dosed with     CTL019. A single dose of CTL019 (consisting of approximately 5x10^9 total cells, with a     minimal acceptable dose for infusion of 1.5x10^7 CTL019 cells) was to be given to subjects as     fractions (10%, 30% and 60% of the total dose) on Day 0, 1 and 2. A second 100% dose of     CTL019 was initially permitted to be given on Day 11 to 14 to subjects, providing they had     adequate tolerance to the first dose and sufficient CTL019 was manufactured.   "
242536|NCT01029379|"     Propofol, (2,6-diisopropylphenol) is a short-acting anesthetic drug used for induction and     maintenance of anesthesia.      The aim of this study is to evaluate plasma concentrations of propofol in relation to depth     of anesthesia, measured by continuous EEG and to correlate plasma concentrations with genetic     analyses of liver enzymes responsible for drug elimination.      Our hypothesis is that there is an individual requirement of Propofol plasma concentration     depending on genetic differences in drug elimination.      200 patients, ASA classification 1, planned for elective surgery of a duration of at least 30     minutes will be included in this study.   "
242537|NCT01029392|"     Our objective is to demonstrate that providing supplemental vitamin D to children with new     onset DM will significantly decrease the levels of HbA1c and insulin requirement by the     following methods.        1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes          mellitus (DM).        2. Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level          over the past few months) and document insulin requirements before and after vitamin          supplementation is given.      Hypothesis: Maintaining vitamin D levels >30 ng/ml will decrease HbA1c and insulin     requirements.   "
242538|NCT01029405|"     The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment B, 2.0%     and 0.5%, compared to Ointment Vehicle B, applied once or twice daily for 12 weeks, in the     treatment of plaque type psoriasis   "
242539|NCT01029418|"     This will be a phase I/II clinical trial testing the combination of sorafenib and AZD6244 in     advanced hepatocellular carcinoma with Childs A liver cirrhosis. The aim of the phase I     portion is to determine appropriate dose of this drug combination. The phase 2 study will     look at effectiveness and safety of this drug combination   "
242540|NCT01029431|"     The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically     engineered for use both as a stand-alone laryngeal mask airway (LMA) and as a rescue device     or Plan B device in the event of a difficult airway. As with some other types of LMA, it is     then possible to insert an endotracheal tube (ETT) through the Air-Q® ILA, either blindly or     mounted on a fibreoptic bronchoscope (FOB), to achieve endotracheal intubation. The objective     of this study is to compare the Air-Q® ILA's performance to the current best option, the     PLMA.   "
242541|NCT01029444|"     The purpose of this study is to determine if restoring normal metabolic function in patients     with either type I or type II diabetes can improve the impact of the consequences of diabetic     complications specifically on the wide swings in blood glucoses with erratic control even     under optimal conditions. Patients are treated once a week with pulsatile intravenous insulin     therapy mimicking normal insulin secretion. Blood sugar diaries and laboratory tests     including quarterly Hemoglobin A1c levels are monitored to measure progress and outcomes.   "
242542|NCT01029470|"     Primary objective:      To evaluate the efficacy in terms of oocyte retrieval number of rLH supplement in women with     hyporesponse to rFSH after pituitary downregulation.      Secondary objective:      To further explore the efficacy of rLH supplement in women with hyporesponse to rFSH after     pituitary downregulation To evaluate the safety of rLH supplementation in hyporesponse women   "
242772|NCT01033383|"     This study will investigate whether there is a particular dose of cranberry capsules that is     effective in preventing the occurrence of urinary tract infections in females at least 65     years of age or older who live in a nursing home and who have a history of urinary tract     infections. The Yale research team will be enrolling 80 subjects in total over several     nursing home locations within Connecticut.   "
242543|NCT01029483|"     Very low carbohydrate diets and high-complex carbohydrate, low-fat diets are popular     weight-loss methods in the United States. The purpose of the Energy Balance Study is to     explore how extreme differences in diet affect eating behaviors, activity and calorie-use,     and body composition.      We will conduct a controlled feeding study (all food will be provided for the duration of the     study) in which obese adults will be randomly assigned to one of three dietary groups: a     low-carbohydrate-eat as much as you like diet, a high-carbohydrate-eat as much as you like     diet, or a high-carbohydrate-calorie-restricted diet. The low-carbohydrate diet will be     modeled after the Induction Phase of the Atkins Diet. The high carbohydrate diet will be     based on the Dietary Approaches to Stop Hypertension (DASH) diet. During the first 3 weeks,     participants will eat a typical diet adjusted so that they neither gain or lose weight. Then,     for 6 weeks, they will eat their assigned research diet. Resting calorie use and body     composition measurements will be taken at the end of week 2 and week 9. Frequent blood     sampling for 24 hours will be done through a catheter (tube) placed in an arm vein at the end     of weeks 2 and week 9 and for 12 hours at the end of week 3.      Change in body composition, activity and energy expenditure, and blood components known to     influence eating behavior will be measured under typical diet conditions and after one-day     and 6 weeks of the research diet.   "
242544|NCT01029496|"     The best time of the umbilical cord clamping has not been fully understood. immediate cord     clamping (with in 10 seconds after birth) has been standardized practice for many years,     while WHO protocol recommends to wait for 60-90 seconds. but the umbilical cord may still     pulse for more than 90 seconds. is it best to wait longer until the pulsing ceased? how the     time of umbilical cord will affect the newborn? will the longer time be less umbilical     bleeding and shorter departure time of the cord? the hypothesis of this study is: to cut the     cord after the pulsing ceased is the best time for cord clamping and will result in better     quality of life for the newborn and less cord bleeding and earlier departure time of the     cord, that means less infections of the cord.   "
242545|NCT01029509|"     The goal of this clinical research study is to find the highest tolerable dose of OPB-31121     that can be given to patients with leukemia or myelodysplastic syndrome (MDS).   "
242546|NCT01029522|"     A multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy     and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher     risk cardiovascular disease in Korea.   "
242547|NCT01029535|"     This is a prospective, open-label experience study to be conducted at 6 clinical sites in     Australia, with the objective to collect efficacy and safety information for Juvederm®     VOLUMA™ when used for volumising the mid-face and cheek area.   "
242548|NCT01029548|"     The present study is designed as a prospective observational study directed at evaluating the     frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune     response in HIV-1 infected asymptomatic individuals, and to prospectively evaluate the     immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative     drug naїve subjects (secondary endpoint) in order to determine the impact of anti-Tat     immunity on HIV disease progression as well as the potential use of anti-Tat immune response     assessment for the clinical and therapeutic management of infected patients. This survey     provided important information for the design, planning and conduction of future therapeutic     vaccine trials based on the HIV-1 Tat protein in asymptomatic subjects.   "
242549|NCT01029561|"     The aim of this project is to study the relationship between obstructive sleep apnea (OSA)     and metabolic syndrome (MS) in a population of obese patients who are candidates for     bariatric surgery. The investigators will study the influence of OSA through hypoxia and     sleep fragmentation on different proinflammatory adipokines and cytokines, on metabolic     syndrome and on insulin resistance, as well as how these respond to treatment with continuous     positive airway pressure (CPAP).      In the first part of the study (part A) the investigators will perform an observational study     of cases and controls. Based on the diagnostic polysomnography the patients will be divided     into two groups depending on their apnea-hypopnea index (AHI): OSA (AHI >= 15/h) and non-OSA     (AHI <15/h). The results will be analyzed depending on the presence or not of OSA.      In the second part of the study (part B), the patients with severe OSA (AHI ≥ 30/h) will be     randomized into two groups: one group will receive CPAP + diet treatment and the other group     will only receive diet treatment. After 3 months of treatment (CPAP + diet vs. diet), the     investigators will analyze the overall effect on metabolic syndrome and the effect on its     individual components, as well as the above-mentioned inflammatory pathways and insulin     sensitivity, between the 2 groups. This will be carried out through a randomized controlled     study in which the investigators will compare the effect of CPAP with the effect of     conservative treatment.   "
242550|NCT01029574|"     Repair of the rotator cuff has high rates of re-rupture (20-54%), despite good clinical     results. Several ways to improve the healing tendon-bone are currently studied, among them     the most used is the use of growth factors. The platelet-rich plasma is a source of several     growth factors, and is already used in various orthopedic procedures. The aim of this study     is to evaluate the effectiveness of platelet-rich plasma in improve tendon-bone healing in     arthroscopic rotator cuff repairs.   "
242562|NCT01029730|"     The goal of this multi-center Phase II study is to add bortezomib to the highly active     regimen of bendamustine and rituximab. In this study, bortezomib will be administered on a     weekly schedule (Days 1, 8, 15) and will be added to bendamustine/rituximab given in 4-week     cycles. This combination uses the standard bendamustine dosing schedule, and is more     convenient than the 5-week regimen of these 3 drugs currently being studied.   "
242678|NCT01032148|"     The purpose of this study is to find out the effects of a drug called LBH589 when given to     people with recurrent or refractory Hodgkin or Non-Hodgkin's lymphoma. The safety of this     drug will also be studied. The participants' physical state, changes in the size of the     tumor, or state of Hodgkin or non-Hodgkin's Lymphoma, and laboratory findings taken while     on-study will help the researchers decide if LBH589 is safe and effective.   "
242773|NCT01033396|"     PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be     exposed to pollen and their symptoms observed.   "
242774|NCT01033409|"     In this Phase I clinical study, three recombinant, avirulent Salmonella Typhi (RASV) strains     each expressing the Streptococcus pneumoniae surface protein, PspA, will be compared as live     biological vaccine vectors to evaluate safe and tolerable, single, oral dose levels in adult     subjects.   "
242551|NCT01029587|"     Catastrophic Antiphospholipid Antibody Syndrome (CAPS) is a rare condition in which     life-threatening blood clots form in multiple organs simultaneously and can lead to     multi-organ system failure and death. The causes of CAPS are not entirely understood, but     CAPS episodes are often triggered by stressful events such as infections, surgery, or trauma.     For patients who survive an episode of CAPS, permanent kidney failure is not uncommon because     the kidneys are the organ system most frequently affected in CAPS. Kidney transplantation is     the treatment of choice for end-stage kidney disease, but patients with a history of CAPS are     exceptionally high-risk kidney transplant recipients because the chance that surgery itself     could trigger a life-threatening or transplant-threatening episode of CAPS is significant. As     a result, patients with CAPS are not generally considered candidates for transplantation.     Despite this, these patients have a severely decreased life-expectancy on dialysis and their     long-term survival and quality of life would be greatly increased by a successful kidney     transplant. In this trial, a drug called eculizumab will be tested for its ability to prevent     CAPS after kidney transplantation in patients with a prior history of CAPS. Eculizumab is an     inhibitor of the complement system, which is believed to be important in generating the     inflammatory environment that leads to diffuse clotting of blood vessels in CAPS. The     investigators hypothesize that by blocking the complement cascade using eculizumab, in     conjunction with blocking the coagulation system, that kidney transplantation can be safely     and successfully performed in patients with a history of CAPS.   "
242552|NCT01029600|"     The purpose of the study is to compare two different treatment regimens for primary frozen     shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid.   "
242553|NCT01029613|"     Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and     course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of     the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with     wholebody MRI etc.   "
242554|NCT01029626|"     The purpose of this study is to validate the Glasgow-Blatchford score for the stratification     of patients with upper gastro-intestinal hemorrhage. This score is easy to calculate. It is     mainly based on the hemoglobin, blood pressure and blood urea. if the score is zero, the     bleeding is very low risk and the gastrointestinal endoscopy may be delayed and performed as     an outpatient.   "
242555|NCT01029639|"     Hypoglycemic unawareness is a major problem in the treatment of Diabetes Mellitus.     Hypoglycemic unawareness is the inability to recognize or sense early symptoms of low blood     sugar. This study was instituted to evaluate the effect of Pulsatile intravenous (IV) Insulin     on improving or reinstating the diabetics ability to sense or feel the symptoms associated     with low blood sugar.   "
242556|NCT01029652|"     The purpose of the 12-week core study was to demonstrate that canakinumab given upon acute     gout flares relieves the signs and symptoms and prevents recurrence of gout flares in     patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs)     and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of     canakinumab was compared to the corticosteroid triamcinolone acetonide.      The purpose of the first 12-week extension study was to collect additional safety,     tolerability and efficacy data in patients who have completed the core study CACZ885H2356.      The purpose of the second 48 week open-label extension study was to collect additional     long-term safety and tolerability data in patients who have completed the first extension     study CACZ885H2356E1.   "
242557|NCT01029665|"     The primary objective of this study is to determine the medical and neurodevelopmental     outcomes of congenital diaphragmatic hernia (CDH) survivors at school-age (4-6 years)     follow-up. It is generally assumed that older CDH survivors have normal daily function and     are able to live normal lives, but this has not been adequately studied.   "
242558|NCT01029678|"     The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC)     treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant     radiotherapy in elderly patients.   "
242559|NCT01029691|"     The purpose of this study is to identify whether sleep-disordered breathing - as measured by     overnight polysomnography - is associated with pre-eclampsia and to determine whether use of     positive airway pressure can improve nocturnal blood pressure.   "
242560|NCT01029704|"     The purpose of this study is to assess the effect of EGT0001442 on fasting plasma glucose     after 28 days of treatment in subjects with type 2 diabetes.      The study will also assess the pharmacokinetics (how much of the drug gets into the blood and     how long it takes the body to get rid of it), safety and tolerability of EGT0001442, the     effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose     produced in the body by the urine.   "
242561|NCT01029717|"     Most children admitted to paediatric intensive care units (PICU) need to have medicines given     to them into their veins using a narrow tube, so they do not need repeated injections. This     tube is called a central venous catheter. Occasionally these catheters can cause infections     in the blood and sometimes the tubes can get blocked by small blood clots.      Some intensive care units already use antibiotic or heparin coated catheters, but there is no     proof that these are better than the standard ones at preventing infections. Most of the     PICU's in this country use standard lines. The only way to find out for certain is to compare     children who are given antibiotic or heparin coated catheters with those who are given     standard ones in a clinical trial. Because we do not know which type of catheter is best, the     type of catheter each child receives in the study will be decided randomly by chance.      Each child in the trial will have the same chance of getting any of these three catheters:        -  Standard central venous catheter (not coated).        -  Heparin coated central venous catheter. Heparin is a medicine that can stop blood from          clotting and might stop the tubes being blocked and infections in the blood.        -  Antibiotic coated central venous catheter. Antibiotics can be used to kill bacteria          which cause the infections.      The aim of this study is to see how the three types of catheters compare in reducing the     amount of blood infections in children. We will also look at the costs involved. We hope to     recruit 1200 children in the UK over 2 years. We hope that the information we get from this     study will guide policy about purchasing impregnated Central Venous Catheters across the NHS     and thereby improve treatment for children in the future.   "
246887|NCT01083927|"     To compare the efficacy of rotational narrow strip conjunctival graft to full conjunctival     graft in primary pterygium excision. Risk analysis of factors that may affects the recurrence     rate.   "
242563|NCT01029743|"     This study is to identify the following problems and questions with respect to the safety and     effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of     venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip     replacement (THR) or total knee replacement (TKR) in the real-life conditions in its     registered indication(s) as required by Korean Food and Drug Administration (KFDA).        1. Known and unknown adverse reactions, especially serious adverse reactions        2. Incidence of adverse reactions under the routine drug use        3. Factors that may affect the safety of the drug        4. Factors that may affect the effectiveness of the drug        5. Other safety information related to overuse, drug interaction and laboratory          abnormalities        6. Other adverse reactions   "
242564|NCT01029756|"     A randomised controlled trial of intubation by inexperienced anaesthetists, comparing the The     Pentax Airway Scope AWS-S100 Rigid Video Laryngoscope(Pentax AWS) and the Macintosh     Laryngoscope.   "
242565|NCT01029769|"     The main aim of the trial is to study whether a change of medication in non-responders to a     two-weeks antipsychotic drug trial is more effective than continued treatment with the same     antipsychotic. Hypothesis: Non-responders who are switched at 2 weeks to another     antipsychotic are more frequently in symptomatic remission at week 8 than non-responders who     stay on the same antipsychotic   "
242566|NCT01029782|"     The purpose of this study is to determine whether oral cephalexin is equivalent to     intravenous cefazolin plus oral probenecid for the treatment of uncomplicated skin and soft     tissue infections in patients that present to the emergency department.   "
242567|NCT01029795|"     The purpose of this study is to help answer the following research question(s):        -  To test if taking LY2599506 for 12 weeks controls blood sugar better than taking          glyburide for 12 weeks.        -  To evaluate the safety of LY2599506 in participants with diabetes.        -  To determine if LY2599506 has the ability to control blood sugar in participants with          diabetes.        -  To determine how much LY2599506 should be given to participants.        -  To determine if LY2599506 has an effect on a participant's weight.      The study design consists of 4 study periods: a screening period, a 4-week dose adjustment     period, an 8-week treatment period, and a 4-week follow up period.   "
242568|NCT01029808|"     To collect and analyze data on female carriers of severe and moderate hemophilia A and B.   "
242569|NCT01029821|"     1. The use of LMWH following open reduction and internal fixation of ankle fractures will          reduce the number of thrombi formed.        2. The rates of clinically significant DVT will be equivalent between two groups.   "
242570|NCT01029834|"     The goal of this study is to test, in the primary care setting, the efficacy of an innovative     intervention program for children aged 2-5 years with a BMI over the 85th percentile and one     overweight parent (BMI >27 kg/m2.   "
242571|NCT01029847|"     Investigation of wholebody MRI and circulating biomarkers of inflammation, cartilage and bone     metabolism in patients with spondyloarthritis treated with adalimumab. Furthermore to compare     ultrasound examination with wholebody MRI etc.   "
242572|NCT01029860|"     The purpose of this study is to assess the effect of hospital admission on 24-hour ambulatory     blood pressure (ABP) in hypertensive subjects.Treated or untreated hypertensive adults with     open angle glaucoma underwent in-hospital and outpatient 24-hour ABP monitoring, in random     order 4 weeks apart.   "
242573|NCT01029873|"     This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation     study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the     safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic     profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have     metastatic melanoma that is considered surgically incurable. The anti-tumor responses of     ALT-801 with cisplatin will also be assessed in this trial.   "
242574|NCT01029886|"     No head to head comparisons between exenatide once weekly and liraglutide have been     performed. Therefore, the purpose of this study is to compare exenatide once weekly to     once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and     other clinical benefits. The study includes a 26-week treatment period and a safety follow-up     visit 10 weeks after the final study drug dose.   "
242575|NCT01029899|"     The study is to evaluate how doctors in training are different from very experienced doctors     when using force to perform colonoscopy with a device that monitors the amount of force     applied to the colonoscope during colonoscopy.   "
242576|NCT01029912|"     Ankle dorsiflexor weakness (paresis) is one of the most frequently persisting consequences of     stroke. The purpose of this exploratory study is to compare two different treatments --     Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) and Cyclic     Neuromuscular Electrical Stimulation (cNMES) -- for improved recovery of ankle movement and     better walking after stroke.   "
242577|NCT01029925|"     The purpose of this study is to determine the response rate by RECIST criteria of oral     dichloroacetate in patients with recurrent and/or metastatic and pretreated breast and     non-small cell lung cancer.   "
242578|NCT01029938|"     Intracranial aneurysm treatment with coil embolization is associated with relatively low     complete occlusion and high recanalization rates. The investigators evaluate whether Willis     covered stent implantation yields angiographic and clinical results superior to those with     coil embolization.   "
242579|NCT01029951|"     The primary purpose of this study was to compare the relative effectiveness of cervical     manipulation, mobilisation and the Activator instrument in the treatment of subacute     non-specific neck pain. The secondary purpose was to describe any adverse effects of these     treatments.   "
242590|NCT01030094|"     The purpose of this study is to investigate the influence of topiramate monotherapy on the     bone and mineral metabolism markers, and bone density (the amount of mineral per square     centimeter of bone ) in female participants with epilepsy (seizure disorder), before     menopause (time in life when a woman stops having a menstrual period), as compared with     healthy participants and comparative group received either carbamazepine or valproic acid     monotherapy for at least last one year.   "
242803|NCT01033786|"     The purpose of this study is to assess length of hospital stay and perioperative     complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year     time period, who did not complete a questionnaire on post-operative recovery.   "
242580|NCT01029964|"     The prevalence of overweight and obesity among children and adolescents has reached epidemic     proportions worldwide. Among Swedish 10-year old children 15-20% are overweight and 3-5% are     obese. The probability that an obese child becomes an obese adult is very high. This chronic     disease requires lifetime treatment. The standard treatment of childhood obesity involves     behavioural interventions focused on eating habits and physical activity. Studies often     include small study samples, the absence of control groups and short treatments times.     Several long-term follow-up studies of shorter interventions are available. The results from     these studies are disappointing since the number of children who are cured i.e., have     become non-obese is low. Thus, effective treatments are currently lacking.The National     Childhood Obesity Center treats children in a University hospital setting. The children are     enrolled from the catchment areas of the hospital as well as the rest of Sweden. Treatment     alternatives include behavioural treatment (individual and group), low and very low calorie     diet, pharmacological and surgical treatment. Patients treated with surgical and     pharmacological methods safety is ensured using these treatments exclusively in controlled     studies. The clinic was the first in Sweden with this wide range of treatment options.      BORIS is a national health care quality register for childhood obesity, supervised by the     Swedish Association of Local Authority and Regions.   "
242581|NCT01029977|"     The purpose of this study is to evaluate the effect of everyday practice modalities     (mammography, US) on the MIRA technology.   "
242582|NCT01029990|"     Women who don't participate in Swedish cytology screening program are a minority of about     10%, but constitute the majority of those who acquire cervical cancer. Over 50 000 women in     the Västra Götalandregion have abstained from participation in the program for at least 2     screening rounds (6 - 10 years, depending om age). We plan to test two promising strategies     to increase participation. In a study of two different health policies women who have     defaulted are randomised to receiving a telephone call from a midwife, receive an offer of a     self-test for HPV or being included in a control group. This is an effectiveness study that     should give an answer how participation could be increased and give the basis for a     calculation of the costs involved, before decisions can be made about implementing either     intervention.   "
242583|NCT01030003|"     The purpose of the study is to determine the prevalence of sleep-disordered breathing in     pregnant women during the third trimester of pregnancy and to investigate whether this is     associated with high blood pressure in the mother and/or growth retardation in the baby.   "
242584|NCT01030016|"     The study was designed to investigate if atenolol is able to blunt blood pressure increase     during resistance exercise in hypertensive subjects.   "
242585|NCT01030029|"     The effect of acupuncture for postoperative pain control remains controversial. We therefore     studied the effects of electrical auricular acupuncture (AA) on postoperative opioid     consumption in a randomized, patient-blinded clinical trial.      40 female patients undergoing laparoscopy were included. Anaesthetized patients were randomly     assigned to receive AA (shen men, thalamus and one segmental organ-specific point) or     electrodes and electrical stimulation for 72 hours. Postoperatively patients received 1 g     paracetamol every 6 hours and additional piritramide on demand. A blinded observer obtained     the doses of piritramide and the visual analogue pain scores (VAS) at 0, 2, 24, 48, and 72     hours.      It was the aim of our study to find out, whether auricular acupuncture reduces postoperative     pain.   "
242586|NCT01030042|"     Primary Objectives:      Aim of this study is to compare the efficacy and safety of two different sequences of     chemotherapeutic agents in order to optimize the treatment of patients with metastatic     colorectal cancer progressed to a first line chemotherapy with FOLFIRI and bevacizumab.     Primary endpoint will be overall survival, defined as the time elapsed from the date of     randomization to the date of patient death due to any cause, or the last date the patient was     known to be alive.      Secondary Objectives Progression free survival, Quality of life, Health resource utilisation     and economic evaluation, Toxicity and incidence of adverse events      The study regimen includes:      Strategy A: FOLFOX-4 followed, after progression, by irinotecan/cetuximab Strategy B:     irinotecan/cetuximab followed, after progression, by FOLFOX-4 Patients will be randomly     assigned to one of the two treatment sequences (with 1:1 ratio) using a block design     randomization procedure stratified according to center.      The patient accrual period is planned for approximately 36 months. To assess OS, all pts will     be followed for up to 18 months after the last patient is randomised. The maximum estimated     study duration is approximately 54 months.All statistical analyses will be based on an     intention-to-treat approach. CONSORT rules will be applied to describe study flow and     protocol deviations.   "
242587|NCT01030055|"     This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and     the effect of food on the bioavailability of TKI258, in adult patients with advanced solid     tumor   "
242588|NCT01030068|"     The purpose of this study is to test whether it is feasible to provide a smoking cessation     program together with a yoga program to help women quit smoking. We anticipate that women     will be enthusiastic about the program and that we will be able to recruit and treat women     for smoking cessation within the designated time frame.   "
242589|NCT01030081|"     1. Study name:Amlodipine Prevents Morning Blood Pressure Surge Study        2. Study drugs:amlodipine (Norvasc®) and nifedipine GITS (Adalat®)        3. Rationale: Several recent studies compared 24-h blood pressure lowering effect of these          2 dihydropyridine drugs, amlodipine and nifedipine GITS, but produced inconsistent          results. Therefore, a randomized controlled trial with a larger sample size is required          to compare these 2 dihydropyridines in the blood pressure control over 24 hours in          general and during early morning hours and at night in particular.        4. Objective: The primary objective of this study is to test the hypothesis that amlodipine          compared with nifedipine GITS has a stronger effect in preventing morning blood pressure          surge (4 am to 8 am) in mild to moderate hypertensive patients.The secondary objective          of the study is to compare the effects of amlodipine and nifedipine GITS in reducing          nighttime blood pressure (10 pm to 4 am) in patients with a decreased nocturnal blood          pressure fall.        5. Study design: The present study is designed as a randomized, actively controlled,          multi-centre parallel group trial (phase Ⅳ) with two equally sized treatment groups:          amlodipine and nifedipine GITS.        6. Study population: 500 hypertensive patients meet the inclusion/exclusion criteria.        7. Randomization and treatment: After stratification for centre, 500 eligible patients will          be randomized into 2 groups. 250 will receive amlodipine 5 mg per day, and 250 will          receive nifedipine GITS 30 mg per day. At 4 weeks of follow-up, the drug dosage per day          may increase to 10 mg of amlodipine and 60 mg of nifedipine GITS, if blood pressure          measured in doctor's office cannot be controlled to a level below 140/90 mm Hg. If there          were no compelling indication, no other antihypertensive drug is allowed during the          2-month trial.        8. Follow up: All patients should give written informed consent at entry into the present          study. In addition to 24-h ambulatory blood pressure monitoring, patients should also          undergo a questionnaire survey and clinical measurements including clinic blood          pressure. Patients will be followed up at the end of 4 weeks and 8 weeks after          randomization.        9. Sample size estimation: The number of required subject for the whole trial is 500.       10. Timeline: October 2009 to July 2013.       11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin          Hospital, Shanghai, China.   "
242591|NCT01030107|"     The purpose of the proposed study is to determine whether the amount children sleep is     associated with changes in hormones, hunger, motivation to eat, and food intake. Fifty     children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study.     For 1 week each, children will be asked to sleep their typical amount, increase their sleep     by 1-½ hours, and decrease their sleep by 1-½ hours. Half of the children will be asked to     increase their sleep first and half to decrease their sleep first. During each week, the     following will be gathered: sleep duration (measured by actigraphy, which is a small device     that measures sleep), levels of hormones measured through blood draws, self-reported hunger     and appetite, food intake (measured by 3 days of 24-hour recall), how motivated children are     to eat (measured using a computer activity), and child height and weight. We believe that     when children sleep less they will show changes in hormones associated with hunger and     appetite, report being hungrier, be more motivated to eat, and eat more food.   "
242592|NCT01030120|"     The purpose of this study is to evaluate the safety and efficacy of etanercept for patients     with chronic idiopathic urticaria unresponsive to antihistamines.   "
242593|NCT01030133|"     Although transcranial magnetic stimulation (TMS) is now considered a minimal risk     intervention, is approved for the treatment of depression, and is widely used around the     world, little is known about mechanisms of action of prefrontal rTMS for depression or pain.     There is some evidence that the prefrontal cortex is involved in perception of control and     may moderate the effects of perceived controllability on emotional reactivity to painful     stimuli. The present study aims to investigate the effects of prefrontal rTMS and perceived     controllability on pain perception in healthy adults.   "
242594|NCT01030146|"     You are being asked to volunteer for a research study. You are being asked to participate in     this study because you have completed at least one month of drug treatment with a nasal     steroid and allergy testing and still have symptoms. This research study is sponsored by     NeilMed Pharmaceuticals, Inc. The purpose of this study is to compare quality of life     outcomes in patients who continue medical treatment plus the use of the NeilMed Sinus Rinse     low-pressure pump with saline. Your participation in this study may help to improve the     management of patients with allergic rhinitis.      Allergic rhinitis is a common health problem, affecting between 10% and 40% of the world's     population. Presently, antihistamines and nasal steroids are the standard treatment for     allergic rhinitis. To further clarify these findings, we propose a study comparing the     differences in quality of life improvements, by using a series of questionnaires, between     subjects electing continued medical management and those electing medical treatment plus     nasal wash.      The investigators in charge of the study are Dr. Rodney J. Schlosser and Dr. Shaun A. Nguyen.     Approximately 40 patients will be enrolled in this study at the Medical University of South     Carolina (MUSC Hospital). You will have the choice of choosing either to receive only medical     treatment or to receive medical treatment with nasal wash.   "
242595|NCT01030159|"     The purpose of this study is to create a large Thailand database documenting the severity of     anemia and its management in the cancer population.   "
242596|NCT01030185|"     To investigate the safety and performance of the Automated Fluid Shunt in patients with     ascites and diuretic resistance.      Study Size and Duration The primary study population will include 40 patients enrolled and     implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.   "
242597|NCT01030198|"     The purpose of this study is to measure the effectiveness of the RevLite Laser in the     treatment of both fresh surgical scars and mature/older scars.   "
242598|NCT01030211|"     Retrospective data in children with dengue hemorrhagic fever (DHF) and dengue shock syndrome     (DSS), and in adults with dengue fever (DF), suggested a lack of benefit from prophylactic     platelet transfusion for severe thrombocytopenia in dengue patients without bleeding.     However, in Taiwan and Singapore, platelet transfusion was given to 13-50% of hospitalised     dengue patients. This is a prospective randomised study to examine the safety and efficacy of     prophylactic platelet transfusion in adults with dengue and severe thrombocytopenia without     bleeding.      The hypotheses are:        1. Prophylactic platelet transfusion is safe in hospitalised dengue patients with severe          thrombocytopenia.        2. Prophylactic platelet transfusion is effective in preventing bleeding in hospitalised          dengue patients with severe thrombocytopenia.   "
242599|NCT01030224|"     The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after     single IV doses.   "
242600|NCT01030237|"     The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison     to Soothe XP in a specified population of dry eye patients.   "
242601|NCT01030250|"     The goal of this study is to increase our understanding of the adjuvant chemotherapy     experience in older and younger adults by prospectively describing the longitudinal     trajectory of functional status, comorbidity, and quality of life from before the initiation     of chemotherapy to 6 months after the completion of treatment in older (65 and older) and     younger (under 65) adults. In addition, we will determine the effect of pre-treatment     physical functioning on physical recovery after the course of adjuvant chemotherapy. The     secondary objective of this study is to explore if factors other than chronological age     (functional status, co-morbid medical conditions, nutritional status, psychological state,     cognitive function, and social support) predicts which patients are more likely to experience     morbidity (defined as grade 3-5 toxicity, hospitalization, dose reduction or delay, or     premature discontinuation of chemotherapy course) from adjuvant chemotherapy.   "
242602|NCT01030263|"     We wish to determine whether biopsies obtained with the technique of fluorescence-aided     confocal endomicroscopy will detect more patients with specialized columnar epithelium than     random biopsies among patients with Barrett's esophagus who are being monitored with     endoscopy.   "
242603|NCT01030276|"     The aim of this study is to investigate the efficacy of bright light therapy in SAD. This is     a placebo-controlled, double-blind randomized controlled trial (RCT).   "
242604|NCT01030289|"     This study aims to evaluate the effectiveness of transcranial direct current stimulation     (tDCS) in decreasing food cravings. Specifically, this study will determine whether healthy     subjects will report decreased food craving following a single 20-minute session of tDCS     (compared to sham tDCS) delivered during and immediately following the exposure to food     stimuli.   "
242605|NCT01030302|"     The purpose of this study is to monitor such factors as a past history, a previous history of     drug use, the degree of response to initial treatment, the frequency of previous therapies,     age, Eastern Cooperative Oncology Group (ECOG) performance status, which is used by doctors     and researchers to assess how a patient's disease is progressing, assess how the disease     affects the daily living abilities of the patient, and determine appropriate treatment and     prognosis, before the bortezomib re-treatment, the concomitant drugs that are used for     re-treatment and the pattern of treatment in patients with multiple myeloma who were     re-treated with injectable bortezomib.   "
242606|NCT01030315|"     Study design:        -  Phase I, first-in-human, randomized, double-blind, placebo-controlled, sequential dose          escalation study of intravenously administered HM10760A in healthy adult Caucasian and          Japanese subjects. Up to 5 dose level cohorts are planned. In each dose level cohort,          subjects will be randomized to receive a single dose of HM10760A or placebo.      Primary Objective:        -  To evaluate safety profile of single intravenous (IV) dose levels of HM10760A in healthy          adult Caucasian and Japanese subjects.   "
242607|NCT01030328|"     This study will examine how an approved drug (TriLipix), when used in combination with a     statin (a drug that lowers blood cholesterol levels), affects the makeup of plaque. Patients     will be randomly assigned to receive either the study treatment (TriLipix plus Atorvastatin)     or the comparison treatment (a placebo). Comparison of the effect on the makeup of plaque     will be done by using coronary artery computed tomography angiography (CTA), which all     participants will have at enrollment and at the end of the study (18 months after     enrollment).   "
242608|NCT01024205|"     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib     malate before surgery may make the tumor smaller and reduce the amount of normal tissue that     needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that     remain after surgery.      PURPOSE: This phase II trial is studying how well giving sunitinib malate before and after     surgery works in treating patients with metastatic kidney cancer.   "
242609|NCT01024218|"     This trial is conducted in Europe. The aim of this clinical trial is to assess the preference     of 2 different needles used by nurses and health assistants. The trial consists of a handling     test followed by a 12 week cross-over study.   "
242610|NCT01024231|"     The purpose of this study is to determine the safety and tolerability of treatment with     BMS-936558 (MDX-1106) in combination with Ipilimumab (BMS-734016) when given at the same time     or as a sequenced regimen in subjects with unresectable Stage III or Stage IV malignant     melanoma (MEL)   "
242611|NCT01024244|"     The purpose of this study is to help answer the following questions:        -  To test if taking LY2599506 for 12 weeks controls blood sugar better than taking placebo          for 12 weeks.        -  To evaluate the safety of LY2599506 in participants with diabetes.        -  To determine if LY2599506 has the ability to control blood sugar in participants with          diabetes.        -  To determine how much LY2599506 should be given to participants.        -  To determine if LY2599506 has an effect on a participant's weight.      The study design consists of 4 study periods: a screening period, a 4-week dose adjustment     period, an 8-week treatment period, and a 4-week follow-up period.   "
242612|NCT01024257|"     PURPOSE: To affirm the effectiveness and complication rate of postoperative single-dose     beta-irradiation (RT) with (90) Sr in the case of primary pterygium in a clinical trial.     METHODS AND MATERIALS: This trial was designed as a prospective, randomized, single center     study. Surgery was performed in all cases according to the conjunctival autograft technique.     One thousand and four patients with 108 pterygia were postoperatively randomized to either     beta-RT or observation. In the case of beta-RT, a (90) Sr eye applicator was used to deliver     1000 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After     treatment, both an ophthalmologist and a radiation oncologist performed the follow-up     examinations. The accumulated data were analyzed using a group sequential test. RESULTS:     Between February 2007 and September 2008, 104 eyes with primary pterygium were operated on     according to the trial protocol. Additional treatment was performed within 24 hours     postoperatively. Four patients were lost to follow-up, resulting in 104 patients who could be     analyzed. In the 54 eyes randomized to receive beta-RT, 5 relapses occurred compared with 8     recurrences in the 50 eyes that no received RT, for a crude control rate of 90.7 % vs. 84 %,     respectively. At a mean follow-up of 9 months (range 4- 18), major treatment complications     had not been observed . CONCLUSION: Single-dose beta-RT of 1000cGy after conjunctival     autograft surgery is a simple, effective, and safe treatment that reduces the risk of primary     pterygium recurrence.   "
242613|NCT01024270|"     The primary outcome measure in this study was the preoperative cervical width after     misoprostol administration. The secondary outcomes were duration of cervical dilatation, up     to Hegar number 10, complications during cervical dilation and the hysteroscopy, and     misoprostol associated side effects. The cervical width was assessed by performing cervical     dilatation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar     dilatators until the dilator could pass through the internal os without resistance. The     largest one that could be passed was recorded as the initial cervical width.      The mean cervical diameter, after oral and vaginal misoprostol of 400 μg, has been reported     to be 6.0 ± 1.5 mm and 7.3 ± 1.6 mm, respectively 4. The investigators hypothesized that     equivalence was of clinical significance if the difference in the initial cervical width was     less than 1 mm among groups with the standard deviation of the initial cervical width of 1.6     mm. The estimated sample size was 47 patients in each group; this would be able to detect an     equivalent effect in the groups with a power of 80% and a type 1 error (a) of 0.017. Data are     expressed as the mean ± SD (standard deviation) or median with range or as the number (%) of     cases.   "
242614|NCT01024283|"     The principal research objective of this additional research protocol is to support the     collection, storage and use of tumour and surrogate (peripheral blood mononuclear cells -     PBMNCs). The objective of this study is to perform assays to study pharmacodynamic (PD)     markers that confirm target modulation.   "
242643|NCT01030458|"     The purpose of this study is to compare the blood pressure lowering efficacy of a treatment     regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II     type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide     diuretic combined with a beta-blocker.   "
242615|NCT01024296|"     During any minimally invasive surgery case, 5-25mm size incisions need to be made to gain     access to the abdomen. One of the most difficult, time-consuming, and sometimes unreliable     parts of the case is closing these incisions, especially in obese patients. This is mainly     because these incisions are very small and the layer that needs to be closed (fascia) rests     deep underneath the skin and fat tissue of the abdominal wall. Two of the investigators (CM     and BS) have developed at Stanford an instrument that allows for an easier and more reliable     closure of these wounds. The purpose of this study is to test this instrument in the closure     of laparoscopic wounds in obese patients undergoing laparoscopic gastric bypass surgery.   "
242616|NCT01024309|"     The purpose is to determine if differences exist in the attainment of functional milestones     that reflect activities of daily living between mini-posterior and direct anterior approach     total hip arthroplasty (THA). The investigators also hope to determine if the general health     outcome after direct anterior total hip arthroplasty was better than that after     mini-posterior-incision total hip arthroplasty as measured with Short Form-12 (SF-12) scores,     and to evaluate variation of surgical factors of the two procedures on the basis of the     operative time, component positioning, and occurrence of early complications.   "
242617|NCT01024322|"     To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen     (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by     inducing additional cross-links within or between collagen fibers using UVA light and the     photo- mediator riboflavin. The purpose of this study is to generate data for presentation at     medical meetings and for peer-review publication   "
242618|NCT01024335|"     The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to     maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that     administering dronabinol during detoxification and during the first few weeks of naltrexone     treatment will lead to improved naltrexone tolerability, resulting in better naltrexone     compliance and treatment retention, and ultimately a reduction in opioid use and relapse     rates.   "
242619|NCT01024348|"     Extended-release tramadol is indicated for the management of moderate to severe pain in     adults who require around-the-clock treatment. It provides an extended duration of action,     more constant plasma concentrations, a reduced dosing frequency, and the potential for     improved compliance and therapeutic outcomes.      The present study was designed to evaluate the safety and effectiveness of this medication in     the treatment of early postoperative pain after knee arthroscopy.   "
242620|NCT01024361|"     The objective of the study is to determine if CPAP applied within less than 15 min of life in     the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days     of life.   "
242621|NCT01024374|"     Clinical single-blind randomized comparison with the overall objective of evaluating the     clinical efficacy of the products Nutracort lotion and Nutracort cream in the treatment of     seborrheic dermatitis on the face.      Will be held clinical and perceived efficacy assessment and instrumental measurements. Each     product will be applied at half face for 7 consecutive days and all applications will be     monitored in the research site. 60 volunteers will be recruited.      Evaluations will be held at the following times: T0 - before the initial application of the     product; T1 - 24 hours after starting treatment, T2 - 48 hours after starting treatment, T3 -     72 hours after initiation of treatment, T4 - 96 hours after the start treatment, T7 - 7 days     after initiation of treatment.   "
242622|NCT01024387|"     The purpose of this research study is to determine the effectiveness of AMG 479 against     carcinoid and pancreatic neuroendocrine tumors. AMG 479 is an antibody that is made in the     laboratory. Antibodies are highly specific proteins produced by the body's immune system that     recognize foreign substances in teh body. AMG 479 has been used in other research studies and     information from those other research studies suggests that AMG 479 may help to prevent the     growth of some neuroendocrine tumors.   "
242623|NCT01024400|"     The purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non     adjuvanted A(H1N1)v influenza vaccine in 120 pregnant women.      Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at     delivery and recording temperature and vaccine side effects in a memory aid for 7 days     following each vaccination. Participants will be involved in study related procedures about 3     at 5 months.   "
242624|NCT01024413|"     This is a randomized controlled trial to compare efficacy and safety between erlotinib and     gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were     randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was     progression-free survival (PFS).   "
242625|NCT01024426|"     The investigators propose to assess whether an intervention to build capacity and improve     delivery of drugs and diagnostics at government-run health facilities improves the health of     children and quality of care delivered, as compared to 'standard care' currently available at     health facilities, supplemented by services provided through the private sector and     community-based interventions. The target population will be divided into 20 clusters,     defined as the catchment area of lower-level public health facilities. Clusters will be     randomized to the health facility intervention (HFI) or to standard care delivered from     government-run health facilities, supplemented by services provided through the private     sector and community-based interventions. The intervention is designed to address barriers to     delivering quality care at health centers and will focus on three components: (1) training     in-charges in health center management, (2) providing training to health workers in fever     case management and patient-centered services, and (3) ensuring adequate supplies of     artemether-lumefantrine and RDTs. Outcomes will be measured in three distinct populations:     (1) cross-sectional surveys of children under 15 years randomly selected from households     within the clusters; (2) a cohort of children under five randomly selected from households     within the clusters and followed for 2 years; and (3) patients attending all government-run     health facilities, including children under five and their caregivers participating in exit     interviews on selected days every six months. The primary outcome of the study is prevalence     of anemia in children under five.   "
242664|NCT01031966|"     The purpose of this explorative trial is to collect preliminary data on efficacy and safety     of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent     influenza vaccine in hemodialysis patients. The final aim is that of gathering information     needed for planning a following confirmatory study on the efficacy and safety of Thymosin     alpha 1 in the same indication.   "
242626|NCT01024439|"     Laparoscopic appendicectomy is widely practiced in Hong Kong nowadays with shorter hospital     stay and less wound complications. Most of the time, three small wounds of less than 10mm     will be adequate enough for the completion of the surgery with minimal pain.      Recently, the concept of Natural Orifice Transluminal Endoscopic Surgery (N.O.T.E.S) led to     the attention of single incision laparoscopic surgery (SILS) again in the surgical community.     SILS is not a new idea. The first SILS for cholecystectomy was reported in 1997 by Navarra et     al. However, the close proximity of the instruments, limitation in triangulation during     dissection and suboptimal exposure of the surgical field has made this approach unpopular in     last decade. Because the concept of N.O.T.E.S and the newly designed access port, surgeons     are now focused again on SILS. The Chinese University of Hong Kong has recently release their     preliminary results on the use of SILS on appendicectomy with satisfactory results in terms     of less post-operative pain and less prominent scar. However, it was a case series with     limited number of patients. In order to test the advantages of SILS on the management of     patients with acute appendicitis, a double blinded randomized clinical trial is conducted.   "
242627|NCT01024452|"     Randomized comparison of warfarin dosing quality between the Hamilton nomogram and a     commercial computer system.      Hypothesis: Mean TTR of patients managed with the commercial computer system is non-inferior     to management with the validated Hamilton Nomogram.   "
242628|NCT01024465|"     A prospective, non-randomized, open-label, multi-center study designed to implant up to     twenty-six (26) CE-marked ReShape™ Balloons in twenty-six (26) patients with body mass index     (BMI) 30-40 to assess the effectiveness of the device. The RIB devices will be used within     their labeled indications and as per their instructions for use. Enrolled patients will be     followed for seven months. The patient will be prescribed a controlled diet, exercise and     counseling. One group of 26 patients will receive treatment as follows: Placement, inflate to     900 cc, remove at 180 days, follow-up 30 days post removal (endoscopic video capture of     placement and removal required).   "
242629|NCT01024478|"     The multicenter study evaluates the diagnostic performance of 3.0 T contrast-enhanced     whole-heart coronary MRA in patients with suspected coronary artery disease.   "
242630|NCT01024491|"     As study to investigate the efficacy and safety of daily doses of paroxetine of 15 and 20 mg     for the treatment of premature ejaculation   "
242631|NCT01024504|"     This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus     bevacizumab combination as first-line treatment in elderly patients with metastatic     colorectal cancer.   "
242632|NCT01024517|"     The purpose of the study is to compare the pharmacokinetics of GLPG0259 as a solid dosage     formulation (with and without food)and an oral solution, and to assess its safety and     tolerability.   "
242633|NCT01024530|"     The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune     killer cells in treating hepatocellular carcinoma patients in：        1. Reduction of tumor size        2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.   "
242634|NCT01030341|"     A pilot study to assess the safety, feasibility, and potential (uncontrolled) efficacy of     continuous glucose monitoring (CGMS) in conjunction with an insulin pump to improve glycemic     control for treatment of type 1 and type 2 diabetic patients with gastroparesis   "
242635|NCT01030354|"     This study will examine whether a higher protein meal replacement diet (consisting of 1 gram     of protein per pound lean body mass) is more effective in causing weight loss compared to a     standard meal replacement protein diet (consisting of ½ gram of protein per pound of lean     body mass). The study will assign approximately 100 subjects (50 each) to the following arms     1) higher meal replacement diet program 2) standard meal replacement diet program. All     participants will meet with a registered dietitian to provide nutrition education and     behavior modification, including general exercise recommendations. As part of your     participation, you must be willing to undergo a measurement of body fat, and blood tests, and     be willing to use Herbalife Meal replacements as part of your diet for the duration of the     study (one year).   "
242636|NCT01030367|"     Organic nitrates increase levels of circulating endothelial progenitor cells (Thum et al.,     Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54). Here, we want to test the effects of     two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor     cells and endothelial function.   "
242637|NCT01030380|"     The purpose of this study was to determine the efficacy of Slendertone® Face™, to tone the     muscles of the face and reduce the signs of facial aging among the following characteristics:     radiance, tone, lift, firmness and complexion, following a 12-week programme of facial muscle     toning. Slendertone® Face is a neuromuscular electrical stimulation (NMES) device which     features a headset unit designed for application to the face for facial toning. The purpose     of the headset is to locate and support a pair of stimulation electrodes on each side of the     face, over the facial nerve just anterior to the ear.   "
242638|NCT01030393|"     Chorionic gonadotrophins (hCG) play an important role in implantation. The aim of the study     is to evaluate the effect of intrauterine injection of hCG before embryo transfer in IVF/ICSI     on the implantation and pregnancy rates. The rational is that intrauterine hCG injection will     attract regulatory T cells and improve implantation.   "
242639|NCT01030406|"     The primary objective of this study is to compare the relative abuse potential of two     different doses of orally administered Acurox Tablets to orally administered     immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.   "
242640|NCT01030419|"     The purpose of this study is to test the effectiveness of a DVD-delivered, home-based,     six-month physical activity intervention for older adults.      A comparative effectiveness study of the FlexToBa DVD exercise program will be conducted in     2014.   "
242641|NCT01030432|"     The purpose of this study is to identify one or more doses of BMS-650032 that, when used in     combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient     activity against hepatitis C virus (Genotypes 1 and 4).   "
242642|NCT01030445|"     To assess whether a non-invasive cardiac output monitor can follow heart function in children     during treatments in the hospital. To establish a normal reference for children who are well     and awake.   "
246902|NCT01084122|"     The purpose of this study is to evaluate the safety and efficacy of intravenous iron sucrose     in patients with hip fracture and surgical intervention to prevent perioperative anemia.   "
242644|NCT01030471|"     There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address     this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to     reduce depressive symptoms, improve family functioning, and improve medication compliance.     The intervention is delivered in two phases (1 - reduction of depressive symptoms and family     conflict, 2 - adherence promotion) as efforts to improve adherence will have a greater     likelihood of success if individual and family functioning variables are addressed first. To     test the effectiveness of this intervention in reducing depressive symptoms and improving     adherence, we will conduct a randomized controlled trial comparing this new intervention to     usual care in a sample of fifty-two adolescents with type 1 diabetes and their primary     caregivers. Given the absence of this type of intervention and the significance of the     problem, this study is timely and important, as it has the potential to positively impact     diabetes-specific health outcomes.   "
242645|NCT01030484|"     The NAFLD Database 2 will recruit at least 1,500 new adult participants suspected or known to     have NAFLD or NASH-related cirrhosis and will also invite adult participants from the prior     NAFLD Database and related studies (PIVENS trial and TONIC trial) to enroll in the NAFLD     Database 2. To elucidate, through the cooperative effort of a multidisciplinary and     multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and     prevention of NAFLD, and in particular its more severe form of NASH and its complications.   "
242646|NCT01030497|"     The goal of this clinical research study is to learn if using the PEMFlex Solo II, a     high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected     to have cancer will give researchers the same or better information about the disease     compared to the images taken with a routine PET/CT.      Researchers will compare the images taken using the PEMFlex Solo II to the images taken     during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s),     magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within     the last 30 days or may have in the next 30 days.   "
242647|NCT01030510|"     The investigators therefore hypothesized that remifentanil could prolong the onset time of     rocuronium, and evaluated the effect of remifentanil on the hemodynamic profiles (arterial     pressure and heart rate) during the anesthetic induction sequence.   "
242648|NCT01030523|"     The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to     standard length implants (OsseoSpeed™) with bone substitution.      The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is     as safe and predictable as placing standard length implants in combination with bone     augmentation.   "
242649|NCT01030536|"     The primary objectives of this study are to determine the maximum tolerated dose (MTD) or     optimal biologic dose (OBD) and safety profile of CAT-8015 in subjects with relapsed or     refractory advanced B-cell NHL (DLBCL, FL, MCL) or CLL.   "
242650|NCT01030549|"     This study was designed to investigate the physiological properties of adult heart using     cardiovascular magnetic resonance imaging in normal volunteers in Latin America.   "
242651|NCT01030562|"     The purpose of this study is to gain a better understanding of the body's response to a human     papillomavirus (HPV) (sexually transmitted disease), vaccine and booster shot. The study will     also determine factors related to adolescents not following vaccination schedules. The HPV     vaccine requires 3 doses (shots). Girls sometimes receive the 3 shots at the recommended time     and sometimes girls receive the shots at non-recommended times. This study will evaluate if     getting the shots at non-recommended times affects the level of protection provided by the     vaccine. Participants will include about 1400 girls 9-17 years old receiving a third dose of     HPV vaccine from their primary care clinician. The parent/legal guardian of each subject may     answer a questionnaire related to the vaccine schedule. Study procedures include: medical     history, questionnaires and blood draws. Participants will be involved in the study for about     6 months from time of enrollment.   "
242652|NCT01030575|"     This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in     blood and urine levels of inositol in premature infants at high risk for retinopathy of     prematurity (ROP) following repeated doses of inositol. Based on previous studies, the     premise is that maintaining inositol concentrations similar to those occurring naturally in     utero will reduce the rates of ROP and bronchopulmonary dysplasia in premature infants. The     objective is to evaluate pharmacokinetics, safety, and clinical outcomes of multiple doses of     three different dose amounts of myo-inositol (provided by Abbott Laboratories) in very low     birth weight premature infants. This study will enroll an estimated 96 infants at 17 NICHD     Neonatal Research Network sites. Infants will be randomly assigned to receive either 10 mg/kg     of 5% inositol, 40 mg/kg of 5% inositol, 80 mg/kg of 5% inositol, or 5% glucose given in the     same volumes and timings as the inositol dosage to maintain masking. Enrollees will receive     their assigned dose or placebo daily, starting within 72 hours of birth, and continuing until     they reach 34 weeks post-menstrual age, 10 weeks chronologic age, or until the time of     hospital discharge, whichever occurs first. The study drug will be administered first     intravenously; as the infants progress to full feeding, the drug will be given enterally     (orally or via feeding tube). Enrollees will be seen for a follow-up examination at 18-22     months corrected age. This pilot study is in preparation for a future Phase III multi-center     randomized controlled trial.   "
242676|NCT01032122|"     The purpose of this study is to determine whether rituximab as an adjuvant therapy in     clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer)     2002) melanoma patients is safe and prolongs overall survival and disease-free interval.   "
242677|NCT01032135|"     1. Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the          full study sample with regard to treatment engagement over weeks 1-12 and          cocaine/alcohol use over weeks 1-24.             -  Hypothesis 1: An intervention that explores several possible treatment options with               the patient and provides the chosen option (e.g., MI-PC) will produce higher rates               of treatment engagement than an intervention focused on engagement in IOP only               (e.g., MI-IOP).             -  Hypothesis 2: An intervention that explores several possible treatment options with               the patient and provides the chosen option (e.g., MI-PC) will produce better               cocaine/alcohol use outcomes than an intervention focused on engagement in IOP only               (MI-IOP).             -  Secondary analysis 1: Among the Non-engaged patients, determine rates of selection               of each of the three options in MI-PC, retention rates within each option, and               cocaine/alcohol use outcomes in each option.             -  Secondary analysis 2: Among the Engaged patients, determine rates of selection of               each of the three options in MI-PC, retention rates within each option, and               cocaine/alcohol use outcomes in each option.        2. Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC          varies as a function of engagement group, with regard to treatment engagement over weeks          1-12 and cocaine/alcohol use outcomes over weeks 1-24.             -  Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP               will be significantly larger among patients in the Non-engaged group than among               those in the Engaged group.             -  Hypothesis 2: The predicted main effect on cocaine/alcohol use outcomes favoring               MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged               group than among those in the Engaged group.   "
243101|NCT01030692|"     The purpose of this study is to determine the safety and effects of rivastigmine and     huperzine A (HupA), potential treatments for cocaine abuse, when used before experimental     administration of cocaine, on a number of physical and psychological measures.   "
242653|NCT01030601|"     Macular Edema (Swelling of a particular site of the retina) can become a significant problem     for Diabetics undergoing Cataract surgery. And a significant number of people who undergo     Cataract surgery each year are diabetics. And when you multiply these two factors together     you are left with a significant number of people who do not gain as much vision as their     peers. Diabetics who develop Macular Edema actually can loose some vision after surgery and     when you follow them up, they don't gain as much vision. This Study aims to prevent such an     event from happening and therefore allow Diabetics to gain as much vision as they can from     cataract surgery. This study will use Dexamethasone injected intravitreally (into the gel of     the eye) at the end of cataract extraction to control Macular edema brought about by surgery.     The main outcome is the central retina thickness and retinal volume as measured by Optical     Coherence Tomography. Secondary outcomes are BCVA and incidence of Laser Treatment.      Other Drugs, life Bevacizumab and Pegaptanib, have been used for this purpose but they are     expensive and have potential systemic side-effects due to anti-VEGF (vascular endothelial     growth factor) actions. Dexamethasone has been used in the eye for decades and is     short-lived, minimizing possible systemic effects. Moreover, this drug is at least 15x     cheaper than the previously mentioned ones and therefore has tremendous benefit for     developing countries. We seek an alternative drug that can reduce or prevent Macular edema at     a less expensive and safer way.   "
242654|NCT01030614|"     Dexamethasone has been reported to reduce postoperative nausea and vomiting (PONV) after     laparoscopic cholecystectomy (LC). However, its effects on other surgical outcomes such as     pain and fatigue have been unclear. We evaluated the efficacy of preoperative dexamethasone     in ameliorating postoperative symptoms after LC.      Methods: Prospective, double-blind, placebo-controlled study, 210 patients scheduled for     elective LC were analyzed after randomization to intravenous dexamethasone (8 mg) or to a     placebo. All patients underwent standardized procedures for general anesthesia and surgery.     Episodes of PONV and pain and fatigue scores were recorded on a visual analogue scale.     Analgesic and antiemetic requirements were also recorded.   "
242655|NCT01030627|"     This pilot study will document the efficacy and acceptability of administration of magnesium     sulfate with the Springfusor pump for patients and staff at two sites where treatment or     preeclampsia with magnesium sulfate is limited or not available. Currently, both sites refer     patients to tertiary care facilities for further treatment.   "
242656|NCT01030640|"     Subcutaneous administration of tanezumab can result in changes in the number of nerves around     the injection site in the thigh.   "
242657|NCT01030653|"     Obese subjects may require a higher fixed oral maintenance dosing regimen of voriconazole     compared to normal weight subjects to achieve comparable plasma exposures. The current study     is designed to address this issue.   "
242658|NCT01030666|"     Study Hypothesis: The administration of 200 mg doxycycline once a day for 7 days after     regenerative periodontal therapy of infrabony defects improves the results of therapy     (clinical vertical attachment gains [CAL-V], bony fill) and reduces postoperative flap     dehiscence and defect exposure.      In each of 90 patients one infrabony defect shall be treated by regenerative techniques     (guided tissue regeneration [GTR], enamel matrix derivative [EMD]). Prior to , 6, 12, and 24     months after surgery clinical measurements (Plaque Index [PlI], probing depth [PD], vertical     clinical attachment level [CAL-V], Gingival Index [GI]) and standardized radiographs are     obtained.   "
242659|NCT01031901|"     This study is a prospective, randomized, double-blind, placebo-controlled evaluation of the     safety of a topically applied formulation of rapamycin to cutaneous fibromatous lesions in     subjects with Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1). Subjects will     apply either a Polyvinylidene fluoride (PVDF) coating (Skincerity) containing rapamycin or     the PVDF coating alone nightly to fibromatous lesions for a duration of six months.      The primary goal of this study is to evaluate the safety of the topical product in patients     with TSC and NF1. The secondary goal of this study is to evaluate the effectiveness of the     topical product for treatment of cutaneous fibromatous lesions.   "
242660|NCT01031914|"     The purpose of this engineering trial is to develop and validate an algorithm that will     deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using     Continuous Positive Airway Pressure (CPAP) therapy. In this trial the investigators will be     evaluating the algorithm's ability to correctly distinguish between sleep and wake.   "
242661|NCT01031927|"     Several lines of evidence implicate glutamatergic dysfunction in the pathophysiology of     obsessive compulsive disorder (OCD). Sarcosine, also known as N-methylglycine, is an     endogenous antagonist of glycine transporter-I (GlyT-I), which potentiates glycine's action     at the glycine site of N-methyl-D-aspartate (NMDA) receptors. In this 10-week open-label     trial, we examined the efficacy and safety of sarcosine treatment in OCD patients.   "
242662|NCT01031940|"     It is essential that anaesthetists successfully perform orotracheal intubation in scenarios     in which intubation is potentially more difficult, such as where anatomical characteristics     predictive of difficult intubation are present.      The CMAC® Laryngoscope is a new intubating device. It is designed to provide a view of the     glottis without alignment of the oral, pharyngeal and tracheal axes.      The CMAC may be especially effective in situations where intubation of the trachea is     potentially difficult.      The efficacy of this device in comparison to the traditional Macintosh laryngoscope and other     novel laryngoscopes is not known.      We aim to compare its performance to that of the Macintosh laryngoscope, the gold standard     device, in patients with one or more anatomical characteristics predictive of difficult     intubation.      The investigators further aim to compare it to the Airtraq® device a device which has been     shown to be superior to the Macintosh laryngoscope in previous trials.      The investigators primary hypothesis is that, in the hands of experienced anaesthetists, time     to intubation would be shorter using the CMAC than using the Macintosh laryngoscope in     patients with two or more anatomical characteristics predictive of difficult intubation.      The investigators further hypothesize that the Airtraq® will be superior the CMAC® with one     or more anatomical characteristics predictive of difficult intubation.   "
242663|NCT01031953|"     RATIONALE: Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent     nausea and vomiting in patients treated with chemotherapy.      PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to     see how well it works in treating patients with nausea and vomiting caused by chemotherapy.   "
242665|NCT01031979|"     The proposed study has three distinct but related research objectives. The first goal is to     measure physiological correlates of successful treatment with Prolonged Exposure (PE) therapy     for posttraumatic stress disorder (PTSD) in veterans of the Iraq and Afghanistan wars.     Individuals with PTSD often experience elevated heart rates and other objectively measurable     signs of anxiety when confronted with safe situations that remind them of past dangerous     situations. We will measure physiological responses and compare the outcomes to patient's     self reported subjective accounts of symptom improvement on traditional measures of PTSD.     Developing a way to measure objective gains in symptoms improvement may help researchers who     are studying ways to improve PTSD treatment. The second goal of the study is to investigate     if yohimbine, a drug found to promote a specific type of learning, will improve treatment     outcomes for veterans in PTSD treatment. The third goal is to investigate if ability to get     used to loud startling audio tones correlates to baseline PTSD pathology and treatment     outcomes for PE. This goal represents an important step forward in understanding     characteristics of heritable traits that are related PTSD. It is significant because such     research may one day lead to the development of individual responder policies that will     assist patients by individualizing treatment plans based on personal characteristics.   "
242666|NCT01031992|"     Hereditary hemorrhagic telangiectasia (HHT, Rendu-Osler-Weber Syndrome) is associated with     frequent nosebleeds in the majority of cases. Several reports in the literature support the     use of antifibrinolytics like Tranexamic acid to reduce nosebleeds. The objectives of the     study are to test if Tranexamic acid taken orally can        1. improve anemia (lead to an increased hemoglobin level)        2. reduce nosebleeds.   "
242667|NCT01032005|"     The main objective of the present study is to assess the impact of double fortified salt     containing iron and iodine on work performance (productivity) of women plantation workers in     India. Efficacy studies have shown that salt double-fortified with iodine and iron can     significantly reduce the incidence rates of iron-deficiency anemia (IDA) and     iodine-deficiency disorders. Double-fortified salt (DFS) can be prepared by mixing     microencapsulated iron compounds into conventionally iodated salt (Yuan et al, 2008). Iron     deficiency anemia affects the work productivity and physical activity. Many studies have     shown that when the individuals with low Hb received iron supplement, their work performance     improved markedly. Animal studies have demonstrated that iron deficient anemic rats had a     lower work tolerance as measured by oxygen consumption than the adult rats with normal Hb     levels (Ohira et al, 1981). Several human studies have demonstrated the effect of iron     supplementation on endurance capacity and work productivity in women (Zhu and Haas, 1997,     1998; Edgerton et al., 1979). Many human studies have also examined the possible linkages     between iron deficiency and concurrent cognitive or behavioral outcomes. Iron supplementation     effective in reducing iron-deficiency anemia would also result in better behavioral and     developmental outcome. Many studies found that IDA had a great influence on cognitive     functions in infants and school children (Lozoff et al., 2003, 1998 and Friel et al., 2003).     However, studies of IDA and cognitive function in adults are few and controversial.      This study will assess iron status and physical and mental performance at 2 time points,     before and after approximately 10 months during which a controlled intervention will take     place on tea estates at the Panighatta Tea Garden near Siliguri, West Bengal. Subjects will     be women between 18 and 50 years of age who are actively employed as full time tea pickers.     The study requires that 2 experimental groups of subjects be identified: a) an experimental     group that consumes double fortified salt (DFS) containing iron + iodine, and b) a control     group that consumes only iodized salt (IS).   "
242668|NCT01032018|"     Patients will be consented and screened within 2 to 6 months of the index ACS. Patients who     have elevated depression (BDI>=15 or BDI>=10 assessed twice over two week period) and who     continue to meet all of the trial's eligibility criteria will be consented. Through informed     consent, both arms of the trial will be described with equipoise as to these approaches to     postACS depression care. Patients who consent to randomization will be enrolled in the     treatment trial.      The intervention phase will be 6 months, and hence the final outcome assessments will be     performed approximately 9 months after the index ACS. Interim measures of depression will be     obtained at 2 and 4 months post-enrollment. Major adverse cardiac events and all-cause     mortality will also be ascertained at 6 months post-enrollment. Quality assurance by an     independent medical event adjudication committee using prospective guidelines will be     employed.   "
242669|NCT01032031|"     There is little information on the effect of oral bioactive compounds on human skin     clinically despite evidence of a beneficial effect from laboratory studies. The aim of this     study is to examine the effect of oral bioactive compounds (green tea and vitamin C) on the     health of human skin by measuring markers of skin health directly and skin nutrient uptake.   "
242670|NCT01032044|"     This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy     (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).      It is a randomized controlled outcomes study including patients already treated for Barrett's     Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure,     with or without pCLE (2 arms will be considered in this study). The procedures will be     carried out per standards of practice with appropriately trained physicians.   "
242671|NCT01032057|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving     radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of     radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter     period of time, may kill more tumor cells and have fewer side effects. It is not yet known     which regimen of chemotherapy given together with radiation therapy is more effective in     treating pancreatic cancer.      PURPOSE: This randomized phase II trial is comparing the side effects of two regimens of     gemcitabine and capecitabine given together with radiation therapy and to see how well they     work in treating patients with locally advanced pancreatic cancer that cannot be removed by     surgery.   "
242672|NCT01032070|"     This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral     etoposide in patients with recurrent or refractory pediatric ependymoma.   "
242673|NCT01032083|"     The aim of this double-blind, placebo-controlled trial is to establish the clinical and cost     effectiveness of an SSRI antidepressant, citalopram, in the management of persistent negative     symptoms of schizophrenia over a year.   "
242674|NCT01032096|"     The main objective of this pilot study is to observe and document the range of changes in the     blood concentrations of certain hormones, inflammatory chemicals and immune chemicals in     response to the stimulus of Head and Neck cancer   "
242675|NCT01032109|"     The purpose of this study is to compare 12-month results of two single initial     treatments—photodynamic therapy with verteporfin alone and this therapy combined with     intravitreal bevacizumab—for neovascular age-related macular degeneration, not including     patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular     degeneration.   "
242679|NCT01032161|"     Despite recent advances in postoperative delirium research, the proportion of children with     postoperative delirium is still high. Although postoperative delirium is a frequent     complication and is associated with the need for more inpatient hospital care and longer     length of hospital stay, little is known about risk factors for recovery room delirium (RRD)     occurred in postanaesthesia care unit. The aim of the study was to determine pre- and     intraoperative risk factors for the development of RRD among children undergoing non     cardiovascular surgery.   "
242680|NCT01032174|"     The purpose of this study is to compare compliance between patients with Acute Bacterial     Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with     Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic     practice.   "
242681|NCT01032187|"     The purpose of this study is to determine if amphotericin B is effective against visceral     leishmaniasis in Brazilian children. Amphotericin B will be compared to meglumine antimoniate     which is the current approved drug used for this disease in Brazil.   "
242682|NCT01032200|"     RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with     cancer receiving radiation therapy to the brain.      PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue     caused by radiation therapy in patients with primary brain tumors.   "
242683|NCT01032213|"     Arterial and venous thrombotic events are the clinical manifestation of postoperative     hypercoagulability. Altered serum magnesium may play a role in the balance of coagulation. In     this study, the investigators investigated the effect of magnesium sulphate on the     postoperative coagulation change in total intravenous anesthesia (TIVA).   "
242684|NCT01032226|"     The purpose of this study is to compare        -  the non invasive measurement of arterial pressure (CNAP monitor)        -  with the invasive measurement of arterial pressure (radial artery catheter) during          induction and maintenance of general anesthesia   "
242685|NCT01032239|"     To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment     (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke     patients with generalized spastic hypertonia who have not reached their therapy goal with     other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score     in the lower extremities.   "
242686|NCT01032252|"     The primary aim of this two-year project for falls prevention is to reduce number of falls     and fall incidence in community-dwelling people of 65 years and older in the setting of     general practitioners. In addition a reduction of fall-related injuries, reduction of     fall-related risk factors and preservation of Quality of Life is to be achieved.      A second goal of this study is the implementation of standardized assessment for fall risk     factors as well as building up a network between instructors for fall prevention exercise and     general practitioners.   "
242687|NCT01032265|"     The purpose of this study is to determine whether treatment of female stress urinary     incontinence using a web-based programme is effective.   "
242688|NCT01032278|"     The goal of this clinical research study is to learn if certain biomarker testing on blood     samples can help to detect heart damage that may occur during chemotherapy. Biomarkers are     chemical markers found in the blood that may be related to heart function. High levels of     these markers may be linked with heart problems such as heart damage.   "
242689|NCT01032291|"     The purpose of this study is to determine whether lenalidomide in combination with cetuximab     is safe and effective in patients with KRAS mutant colorectal cancer.   "
242690|NCT01032304|"     The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on     exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD.     Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and     quality of life, and the long-term safety of the drug will be assessed.   "
242691|NCT01032317|"     The purpose of this study is to study the treatment of Atrial Fibrillation and ischemic     Ventricular Tachycardia using a RF ablation catheter with contact force sensing capabilities.   "
242692|NCT01032330|"     The present study is being conducted to assess the natural history of intermittent exotropia     and to establish the effectiveness of occlusion in its treatment.      Study Objectives:        -  To determine the effectiveness of occlusion for the treatment of intermittent exotropia          among patients aged 3 to < 11 years who have baseline near stereoacuity of 400 arcsec or          better by Preschool Randot stereotest        -  To determine the natural history of intermittent exotropia among patients aged 3 to < 11          years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot          stereotest   "
242693|NCT01032343|"     Skin cancer incidence continues to rise and ultraviolet radiation (UVR) in sunlight is the     principal cause. Solar UVR can promote cancer development through its ability to suppress the     immune system. The purpose of this study is to determine whether dietary supplementation with     omega-3 polyunsaturated fatty acids can protect human skin from UVR-induced     immunosuppression.   "
242694|NCT01032356|"     The purpose of this study was to examine the efficacy of dynamic splinting as a therapeutic     modality in reducing contracture following surgical treatment of distal radius fractures.   "
242695|NCT01032369|"     In this randomized case control study we will evaluate the additive effect of psychological     intervention, i.e CBT-cognitive behavioral treatment in a multi-strategy weight loss program     composed of physical activity intervention and nutritional programme.   "
242696|NCT01032382|"     The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy     of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in     subjects with cutaneous leishmaniasis (CL).   "
242697|NCT01032395|"     This is a phase III, randomized, controlled, open label study with two vaccine regimens. The     study will assess the relative safety and immunogenicity of vaccine regimens comparing     adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine     in subjects with Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus, and     to compare safety and immunogenicity data with a contemporaneously enrolled control group of     age-comparable, healthy subjects.      Because certain individuals may be hypo-responsive to influenza vaccination, additional     studies with high-risk groups are warranted in order to determine the optimal vaccine     formulation and dosing schedule for prevention of novel H1N1 virus infection.   "
242698|NCT01032408|"     This is a phase III, randomized, controlled, open label study with two vaccine regimens. The     study will assess the relative safety and immunogenicity of vaccine regimens comparing     adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine     in subjects with Human Immunodeficiency Virus Type 1 (HIV-1) Infection and to compare safety     and immunogenicity data with a contemporaneously enrolled control group of age-comparable,     healthy subjects.      Because certain individuals may be hypo-responsive to influenza vaccination, additional     studies with high-risk groups are warranted in order to determine the optimal vaccine     formulation and dosing schedule for prevention of novel H1N1 virus infection.   "
242699|NCT01032421|"     The current study's primary aim is to investigate the association between neuroendocrine     fluctuations and mood disorders by monitoring mood states over distinct hormonal phases     during in-vitro-fertilization (IVF) treatment. The secondary goal of this study is to explore     psychological profiles and coping mechanisms of women undergoing IVF, and to identify the     ones that are associated with successful psychological adaptation to the process and a     successful biological outcome.   "
242700|NCT01032434|"     Major depressive disorder is associated with several sleep Polysomnograph (PSG) findings: (1)     impaired sleep continuity; (2) non-REM (NREM) changes; and (3) enhanced rapid eye movement     (REM) sleep. The first two patterns are common in other psychiatric disorders, while the REM     pattern is very characteristic in depression, so the phase-advance theory was accepted by     most of psychiatrists. Many researchers have focused on the biological rhythm to investigate     the etiological and pathophysiology of depression, and they think depression can be cured if     its sleep abnormality is ameliorated.      It is well known that most of antidepressants treat depression through 5-hydroxytryptamine     (5-HT) neurons. 5-HT also affects the regulation of the sleep-wake cycle and the sleep     microarchitecture. Many all-night PSG studies have shown tricyclic antidepressants can     ameliorate the sleep architecture abnormality in depression by producing rapid suppression of     REM sleep.      Compared to TCAs, SSRIs are generally less sedating because of its high selectivity for     serotonin receptors. SSRIs can suppress REM sleep and delay REM latency too, but they     increase awakenings and reduce SWS at the same time. One PSG study shown sertraline minimally     increases sleep efficiency and reduces nocturnal wakefulness time, which may benefit     depressive patients. However, this study compared the sleep architecture before and after 12     weeks of pharmacotherapy, so the tolerance to the disturbance of sleep architecture in     antidepressants appears to develop over several weeks of treatment. Sertraline has a greater     potency against 5-HT reuptake as well as better selectivity for 5-HT reuptake relative to NE     reuptake than any other SSRIs, and the relative selectivity of sertraline for inhabiting 5-HT     reuptake relative to DA reuptake is somewhat less than of any other SSRIs. So it has chance     to exhibit better effect on sleep architecture in depressive patients.      Finally, it is difficult to be determined that the unique phenomenon of sertraline is its     genuine characteristics or the tolerance after 12-week treatment, so it is crucial to assess     the effect of sertraline on sleep architecture in acute treatment. We hypothesized that     sertraline could suppress the REM sleep, and have little damage to the sleep architecture of     depressive patient.   "
242701|NCT01032447|"     Pilot study for assessing the effectiveness of a Navigator program to aid in clinical trial     participation amongst the Chinese demographic   "
242702|NCT01032460|"     It is essential that anaesthetists successfully perform orotracheal intubation in scenarios     in which intubation is potentially more difficult, such as where the neck is immobilized.      The Airtraq® Laryngoscope and the CMAC are new intubating devices. They are designed to     provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.      These devices may be especially effective in situations where intubation of the trachea is     potentially difficult.      The efficacy of these devices in comparison to the traditional Macintosh laryngoscope in     situations where the cervical spine is immobilized is not known.      The investigators aim to compare the performances of the Airtraq® Laryngoscope and the CMAC     to that of the Macintosh laryngoscope, the gold standard device, in patients in which the     cervical spine has been immobilized by means of a Manual in-line stabilization of the spine.      Hypothesis: The primary hypothesis is that, in the hands of experienced anaesthetists, time     to intubation would be shorter using the indirect laryngoscopes, than using the Macintosh     laryngoscope in simulated difficult laryngoscopy.   "
242703|NCT01032473|"     Anxiety disorders are among the most common mental disorders in children, affecting     approximately 1 out of every 10 children and adolescents. Symptoms of anxiety disorders may     include excessive fear/anxiety/worry, somatic complaints such as headaches and muscle aches,     and impaired social and family relationships. Some children with anxiety also experience     sleep problems, however, little is known about the sleep patterns of anxious children. The     purpose of the study, conducted at Children's National Medical Center, is to examine the     sleep characteristics of children with Generalized Anxiety Disorder (GAD) compared to a     control group of children without GAD to see how sleep behaviors and daytime behaviors are     related.   "
242704|NCT01032486|"     The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances     in Parkinson's Disease patients, after 2 months of treatment.   "
242705|NCT01032499|"     To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils     or acne.   "
242706|NCT01032512|"     After surgical treatment, numerous trials using early postoperative enteral or parenteral     nutritional support have been attempted, in order to reduce morbidity and mortality. Although     it is difficult to compare among heterogeneous interventions, most of them have not been     successful, a fact generally attributed to the timing of the intervention. On the other hand,     nutrients that become conditionally essential under certain stressful circumstances, the so     called nutraceuticals, have been incorporated into nutritional formulations. Both facts have     prompted the idea of pre or perioperative nutrition support, using specific formulations     called immune enhancing formulas, containing arginine, nucleotides, glutamine and omega3     fatty acids in varying concentrations. The provision of these nutraceuticals prior and early     after the surgical, and particularly in oncologic surgery, theoretically permits to obtain     adequate circulating and tissue concentrations for the moment when they are most needed.     Exclusive postoperative provision of these substances would not be able to replenish depots     and provide them for an adequate immune response and wound healing after surgery. However,     regarding the preoperative approach, it is still not know which patients benefit more (less     or more severely malnourished), which specific nutrient(s) are responsible for the positive     effects, and the precise timing these nutrients should be provided. The present study aims to     demonstrate that immune-enhancing formulas are superior to standard enteral products in     reducing postoperative nutrition-related complications.   "
242769|NCT01033344|"     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with     allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived     peptide desensitising vaccine, currently being developed for the treatment of cat allergy.      This study will look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat     allergic subjects following challenge to cat allergen in an EEC.   "
242707|NCT01032525|"     This phase is to register all subjects in Monroe County, New York with Inflammatory Bowel     Disease (IBD) not already included to update the database for years 1990-2003. This will give     us a truly population based study which will add to our knowledge of IBD epidemiology,     allowing us to compare our rates with the rest of the world. We will be able to provide     accurate incidence data from 1980 to 2000, and point prevalence from 12/31/2000. It will have     special significance because of the relatively stable Monroe County population prior to 2000     (population in 1970=711,917; population in 2000 = 735,343).   "
242708|NCT01032538|"     The objective of this prospective study is to determine (1) the time course of     patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome     Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following     Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and     daily function during the study period, are of particular interest.   "
242709|NCT01032551|"     Coronary angiogram (CA) procedures, with and without angioplasty, can be performed via     vascular access in the wrist (radial artery) or leg (femoral artery). Both radial and femoral     artery vascular access have their advantages and disadvantages, but neither has yet been     proven to have superior health outcomes. Often patients are eligible for both access sites     but are not well informed regarding the potential advantages and disadvantages of each site.     Vascular access in cardiac catheterization can be considered a grey zone, where the     benefits and harms may have different levels of significance depending on the individual's     preferences and values. For example, patients with significant back pain may not prefer the     femoral approach as it requires the patient to lie flay for an extended period of time     compared to the radial approach.      For grey zone health care options, Patient Decision Aids (PtDA) have been demonstrated to     improve the quality of decision making by significantly improving knowledge of the patient's     health care options, improving the patient's accurate risk perception, and improving value     congruence with the chosen options.      The investigators propose a randomized controlled trial (RCT) to evaluate the decision     quality impact of a vascular access PtDA compared to usual care in eligible patient's     undergoing elective CA procedures. If the PtDA is demonstrated to positively impact the     decision quality of patients prior to CA procedures, it would be an invaluable bedside tool     to promote patient informed medical decision making.      Hypothesis:      The investigators believe that a PtDA, when compared to usual care, will positively impact     the decision quality and the process of decision making, relating to vascular access options     in eligible patients undergoing elective CA procedures.   "
242710|NCT01032564|"     In obstetric, the investigators can't predict accurately with current means (BISHOP score,     traditional cervix ultrasonography and fibronectin) the childbirth time and delay.      If ultrasonography can determine the length, the cervix opening, it can't define its     flexibility. Indeed, the conventional cervix ultrasonography can't inform us about the     consistency of the uterine cervix.      The elastography (elasticity imagery) is an innovating technology. It is a new technology     currently used as part of breast cancer estimate. This diagnosis mean use the ultrasonography     to measure the tissues answer under pressure.      Its contribution in obstetric must be estimated to improve patients minimum fare.      The main target of the investigators study is to estimate the interest of the measure of     cervix elasticity degree by elastography in prediction of premature birth within a population     of pregnant women   "
242711|NCT01032577|"     The PropR study will evaluate sensing during ventricular fibrillation (VF) in both bipolar     and extended bipolar configurations, in order to evaluate if both can be used interchangeably     in caring for patients. In addition, follow up evaluation of R wave amplitude over time would     allow us to determine whether one configuration is more likely to be associated with change.     This understanding would be important in selecting the proper configuration at the time of     implant.   "
242712|NCT01032590|"     RATIONALE: A personalized Internet-based weight-loss program may help improve the quality of     life for colorectal cancer survivors.      PURPOSE: This randomized phase I trial is studying how well an Internet-based program works     in helping colorectal cancer survivors lose weight.   "
242713|NCT01032603|"     The purpose of this study is to evaluate the effectiveness of bilateral lateral rectus muscle     recession versus unilateral lateral rectus recession with medial rectus resection procedures     for the treatment of basic type and pseudo divergence excess type intermittent exotropia.   "
242714|NCT01032616|"     Splanchnic uptake and metabolism contributes significantly to the differences in flux seen     between the intravenous and intragastric ingestion of certain indispensable amino acids.      This is the third in a series of studies designed to increase the investigators knowledge of     the metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed.     In the initial two studies the investigators established the neonatal parenteral requirement     of threonine and lysine. In the current study, the investigators will be examining the     differences in uptake and metabolism of threonine and lysine across the splanchnic bed.   "
242715|NCT01032629|"     The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2     diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac     events (MACE). Other objectives include evaluating the overall safety, tolerability, and     effectiveness of canagliflozin.      The data from this study will be combined with the data from CANVAS-R study (Study of the     Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a     pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing     requirements for canagliflozin.   "
242716|NCT01032642|"     The investigators will use a thin catheter for HSG and apply pressure on the cervix with the     vaginal speculum to prevent leakage of the dye during injection to study the uterine cavity     and fallopian tubes and reduce the pain as compared to a standard metal cannula.   "
242730|NCT01032837|"     This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the     efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the     safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza     strain or influenza A are eligible for this study. Patients will be randomized to one of four     treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg     (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body     weight-adjusted for pediatric patients.   "
242717|NCT01032655|"     Background: Helicobacter pylori infection has been shown to be associated with the     development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection     could reduce the occurence or recurrence of these diseases. However, it was estimated that     15-20% of patients would fail from first line standard eradication therapy and need second     line rescue therapy. About 15-30% of patient would fail from second line therapy and need to     be rescued with third line therapy. The commonly used salvage regimens include (1) Bismuth     based quadruple therapy (combined with ranitidine or PPI plus two antibiotics) (2)     Levofloxacin or moxifloxacin or rifabutin based triple therapy. However, Bismuth is not     available in many countries and the administration method is complex. Its usage is limited by     the high pill number and low compliance rate. In recent years, the concept of sequential     therapy has been advocated in the treatment of H. pylori infection. The regimen includes a     PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin and metronidazole     for another five days. The eradication rate in the first line treatment of sequential therapy     had been reported to be as high as 90%. More importantly, it has been demonstrated that the     eradication rate among patients with clarithromycin-resistant strains could be as high as     89%. According to the Maastricht III consensus meeting, it was recommended that     susceptibility test should be done for patients who failed two treatments. Therefore, we     aimed to assess the efficacy of susceptibility test driven sequential therapy as the third     line therapy for those who fail from two standard eradication therapies.      Methods: This will be a multi-center, open labeled pilot study        1. Patients:             -  Open labeled, non-comparative pilot study        2. Testing for H. pylori infection:             -  Before salvage treatment:           either (1) any two positive of CLO test, histology, and culture or (2) a positive          C13-UBT will be considered as failure of previous eradication treatment EGD with gastric          biopsy will be done for H. pylori culture and susceptibility test             -  After salvage treatment: C13-UBT will be used to assess the existence of H. pylori               after 2nd or 3rd line salvage therapy        3. Treatment regimens and assignment:             -  D1-7: Nexium (40 mg, bid), Amolin (1 gm, bid)             -  D8-14: Nexium (40 mg, bid), Flagyl (500 mg, bid) plus either one of the following               according to antibiotic susceptibility test (1) Klaricid, 500 mg, bid or (2)               Cravit, 250 mg, bid or (3) Tetracycline, 500 mg, bid        4. Outcome Measurement:             -  Primary End Point: Eradication rate will be evaluated according to Intent-to-treat               (ITT) and per-protocol (PP) analyses             -  Secondary End Point: the eradication rate according to antibiotic susceptibility               before salvage therapy   "
242718|NCT01032668|"     Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac     events in patients with clopidogrel resistance   "
242719|NCT01032681|"     Primary trial objective in this three arm trial is to assess the safety and tolerability of     EMD 521873, and to determine whether the maximum tolerated dose (MTD) is reached with EMD     521873 doses of up to 1.5 mg/kg given alone or in combination with fixed, low-dose     cyclophosphamide (CPA) in patients with metastatic or locally advanced solid tumors or B-cell     non-Hodgkin lymphoma.      Secondary objectives are to evaluate pharmacokinetic, immunogenicity, overall and best     clinical response, changes in tumor marker levels, survival and biological/immune responses     to EMD 521873. A total of 78 patients are planned. Patients will remain on the dose     throughout the trial. It is intended to administer 3 cycles (21 d each, or until progression     or a xxx line therapy becomes necessary.   "
242720|NCT01032694|"     To compare compliance between patients with CAP treated with Azithromycin SR 2.0 g single     dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric     treatment of CAP in outpatient clinic practice.   "
242721|NCT01032720|"     To determine if ultrasound-guided knee steroid injections are more effective than sham     ultrasound knee steroid injections for the treatment of osteoarthritis.   "
242722|NCT01032733|"     Obesity and sedentary lifestyle are associated with physical impairments and biological     changes in older adults. Weight loss combined with exercise may reduce inflammation and may     improve physical functioning in older adults who are overweight or obese and sedentary.     However, the mechanisms by which weight change and exercise influence physical functioning     and sarcopenia remain largely understudied. ions). In the WL+E group, participants attended a     group-based weight management session plus three supervised exercise sessions each week     throughout the entire study. During each exercise session, participants engaged in both     aerobic activities (i.e., walking) and lower body resistance training of moderate intensity.     The participants in the educational control group attended monthly health education lectures     on topics relevant to older adults. It was hypothesized that participants assigned to the     WL+E intervention would 1) lose a larger amount of weight, 2) improve their physical function     levels, and 3) reduce levels of oxidative stress and inflammation to a greater degree than     participants assigned to the Educational Control group. Outcomes are: 1) body weight, 2)     walking speed (assessed by 400 meter walk test), 3) the Short Physical Performance Battery     [SPPB], and 4) knee extension isokinetic strength. The objectives of this pilot study are     fourfold: 1) to demonstrate the feasibility, acceptability, and efficacy of the proposed WL+E     intervention in a sample of 40 sedentary, obese older adults with impaired physical     functioning; 2) to examine the biological effects of the intervention on inflammatory     processes, oxidative stress, apoptosis, sarcopenia, muscle and body composition, muscle     strength, and functional performance; 3) to determine whether the expected beneficial effects     of the WL+E intervention on physical functioning are mediated by changes in inflammation,     apoptosis, and sarcopenia; and 4) to determine the effect size of the WL+E intervention on     key outcomes and provide the basis for sample size calculations in the planning of a larger     RCT.   "
242723|NCT01032746|"     RATIONALE: Use of a web-based risk assessment tool may help improve screening rates for     colorectal cancer.      PURPOSE: This randomized clinical trial is studying personal electronic health records to see     how well they work in improving screening rates for colorectal cancer.   "
242724|NCT01032759|"     Memantine is associated with improvement in pain relief after surgery.   "
242725|NCT01032772|"     Choices Plus, a randomized controlled study, will determine the efficacy of the Project     CHOICES intervention plus a referral to an evidence-based smoking cessation program in     reducing the risk of alcohol- and tobacco-exposed pregnancies.   "
242726|NCT01032785|"     It is known that the foramen ovale closes in most infants during the first 6 months of life,     however, most of the important papers in the field concentrated on observing infants with     murmurs and following those with patent foramen ovale by echocardiography until 6-24 months.     The purpose of this study is to observe the natural profile of closure of the foramen ovale     and ductus arteriosus for the first 36 hours after birth. This understanding may help to     avoid unnecessary treatment and exams for newborns with findings that are natural for their     stage of development.   "
242727|NCT01032798|"     This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a     previously reported liposome-encapsulated mepivacaine formulations.   "
242728|NCT01032811|"     This is a pilot study that will be an exploratory investigation of the rate of occurrence of     ADHD/S-ADHD in adolescent cancer survivors. The procedures that will be used for identifying     attention problem symptoms, determining the frequency and severity of such symptoms, and     characterizing the level of impairment resulting from the symptoms are novel to pediatric     oncology research.This pilot study will draw from the approach used in traumatic brain injury     research of post-injury effects to illuminate more clearly the nature of attentional late     effects experienced by survivors of childhood cancer.   "
242729|NCT01032824|"     The purpose of this study is to conduct a randomized control trial of a behavioral     intervention delivered by counselors via telephone to determine if this is an efficacious     method for improving medication adherence and health-related quality of life for persons who     are 50 and older and living with HIV/AIDS and other chronic conditions.   "
242770|NCT01033357|"     The purpose of this study is to determine whether the long term use of the experimental     Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing     hemodialysis access (via an expanded polytetrafluoroethylene (ePTFE) graft).   "
242731|NCT01032850|"     This research study will evaluate Sorafenib (Nexavar®) and Capecitabine (Xeloda®) to see the     following:        -  how effective this combination of study drugs will be in treating HCC        -  how long subjects respond to these study drugs        -  what types of side effects can be expected, and        -  how severe the side effects are      All subjects in this study will receive:        -  Sorafenib twice a day by mouth        -  Capecitabine twice a day by mouth      Treatment will be given in a 28-day treatment cycle.      Subjects will take sorafenib every day of the cycle. Subjects will take capecitabine on days     1-7 and 15-21 of the cycle   "
242732|NCT01032863|"     Study hypothesis:- Benign joint hyper mobility syndrome which persists into adulthood is a     special type of benign joint hyper mobility which is more likely to predispose to chronic     musculoskeletal pain.      Young Indian adults aged between 25 and 40 years who are blood donors or relatives of     patients admitted as inpatient or presenting to the out patient department, in Amrita     Institute of Medical Sciences will be enrolled, after excluding the exclusionary criteria.     They will be assessed for the presence of chronic musculoskeletal pain using a validated self     filled questionnaire. The primary investigator who will be blinded to their response will     examine them for the presence of Benign Joint Hyper mobility Syndrome and for tender points     suggestive of fibromyalgia.      Primary Objective:- To determine whether chronic musculoskeletal pain is associated with     Hypermobility among Indian adults.      Study design:- Cross sectional survey   "
242733|NCT01032876|"     Neonates with a congenital heart defect are often in need of early cardiac surgery. In     complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without     deep hypothermic circulatory arrest (DHCA). The brain is especially vulnerable to ischemic     injury, which puts neonates undergoing complex operations at high risk of neurodevelopmental     disorders. Selective antegrade cerebral perfusion (ACP) instead of DHCA during these complex     operations may contribute to less cerebral damage, but literature is not conclusive on this     issue.      Therefore, the investigators will perform a randomised controlled trial comparing DHCA and     ACP in neonatal aortic arch reconstructions, focusing on cerebral damage and neurological     outcome.   "
242734|NCT01032889|"     Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the     reduction of submental fat (fat below the chin).   "
242735|NCT01032902|"     This study has been designed to evaluate the performance of the Chembio Diagnostics Systems,     Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of     antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or     plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.   "
242736|NCT01032915|"     This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the     treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic     immunosuppression.   "
242737|NCT01032928|"     Cancers of the head and neck require surgical, radiation, and chemotherapy treatments that     are intended to cure the disease. These treatments have toxic effects on muscles and     structures that are necessary to swallow safely and efficiently. The resulting swallowing     problems (dysphagia) often remain chronic for Veterans and interfere with their ability to     eat and drink. The cost burden to the VA health system is high. There is an urgent need to     develop rehabilitative treatments that lessen these burdens. The proposed research is     designed to test a novel swallowing therapy that includes the coordination of breathing with     swallowing. Our study will train medically and surgically treated, chronically dysphagic     Veterans with histories of oropharyngeal cancer in a novel therapy that involves both     swallowing and respiratory systems. If the therapy is found to be effective, the long term     goal of the project is to extend the study to a multi-site, clinical trial and test the     longstanding effect of this treatment compared to other swallowing therapies on swallowing     function, QOL and cost.   "
242738|NCT01032941|"     The investigators will address the hypothesis that portal hypertension is mediated in part by     bacterial or endotoxin translocation and the production of inflammatory mediators (tumor     necrosis factor-α (TNFα), etc.). The investigators hypothesize that food supplementation with     the probiotic product VSL#3 in patients with Child Pugh B/C cirrhosis will have a beneficial     effect on in portal pressure (as measured by the HVPG) by reducing inflammatory mediators and     improving systemic and splanchnic hemodynamics.   "
242739|NCT01032954|"     This is an open-label and phase IV study of full face injections of variable doses of BT-A.     As it is an open-label and not blind study, both investigator and subjects will know the     injection local and doses of the study drug. Patients will be randomized into 3 different     groups. Each group will receive a specific dose according with the indication evaluated by     the investigator. Six visits will be schedule in this study.   "
242740|NCT01032967|"     The aim of this study is to compare outcomes in patients with operable squamous carcinoma of     the esophagus who have received either surgery or definitive chemoradiation (CRT).   "
242741|NCT01032980|"     This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted     A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza     vaccine) to meet regulatory requirements for post-marketing safety monitoring.      Primary objective:      To describe the incidence of serious adverse events and adverse events of special interest     (AESIs) after HUMENZA or PANENZA administration throughout the study in different age groups.      Secondary objective:      To describe the incidence of non-serious cutaneous allergic reactions after HUMENZA or     PANENZA administration in different age groups up to 21 days after the last vaccination.This     study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted     A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza     vaccine) to meet regulatory requirements for post-marketing safety monitoring.   "
242742|NCT01032993|"     This study will evaluate whether a dietary supplement, coenzyme Q10 (CoQ10), will improve     muscle symptoms, such as muscle aches, pains, cramps, and/or weakness, which are experienced     by some individuals who use statin medications.   "
242771|NCT01033370|"     This study is a single center, non-randomized, open-label, pilot efficacy and safety study     evaluating the ability of clevidipine IV antihypertensive to rapidly control elevated blood     pressure (BP) in the setting of an acute aortic emergencies (aneurysm, dissection or other     aortic disease).   "
243102|NCT01030705|"     This study will collect data on features for future pacemakers via an external     non-implantable system.   "
242743|NCT01033006|"     Background and aims:      Magnetic resonance imaging (MRI) has proved beneficial for presenting anatomy for regional     anaesthesia and to demonstrate spread of local anaesthetic.      A new axillary plexus block with a triple injection (1), combining a short axillary catheter     method with a transarterial axillary block, is now being evaluated with a 3 Tesla MRI. In     this study, the investigators are investigating MR visualisation of three different block     techniques and compare the clinical efficacy of the techniques, with the MR findings.      Patients & Methods:      After obtaining approval of the protocol from the regional ethical committee, 3 x 15 adult     patients, scheduled for hand surgery, were included in a randomised, blinded prospective     study.   "
242744|NCT01033019|"     This was a double-blinded, randomized, vehicle-controlled study in sporadic superficial BCC     (sBCC) and nodular BCC (nBCC) patients which consisted of a 21-day screening period, a     treatment period of 6 weeks (topical 0.75% LDE225 cream application b.i.d) ending with post     treatment biopsies, as safety visit one week after final study drug administration (Day 50),     a visit on Day 83 for excision of the treated BCC, and an end of study evaluation (Day 90).   "
242745|NCT01033032|"     Doxorubicin has been an integral part of the treatment of women with breast cancer for many     years. Since amrubicin may have more activity than doxorubicin, as well as less     cardiotoxicity, evaluation of amrubicin in the treatment of advanced breast cancer should be     a priority. In this Phase II study, the investigators propose an evaluation of single-agent     amrubicin as second- or third-line treatment for women with metastatic breast cancer.   "
242746|NCT01033045|"     The purpose of this study is to describe the management of patients with chronic hepatitis C     and previous treatment failure.   "
242747|NCT01033058|"     This is a retrospective, randomized, parallel, open-labeled, controlled study to find out     whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin     treatment compared with routine treatment.   "
242748|NCT01033071|"     The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil     plus chlorthalidone, once daily (QD), to olmesartan medoxomil plus hydrochlorothiazide in     participants with moderate to severe hypertension.   "
242749|NCT01033084|"     The purpose of this study is to determine whether transcranial direct current stimulation is     an effective treatment for major depression, when compared (and combined) to sertraline and     placebo.   "
242750|NCT01033097|"     This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis     suffering from pruritus, who require systemic treatment of the disease.   "
242751|NCT01033110|"     Background:      Despite the well-known benefits of exercise, 64% of the Swiss population do not fulfill the     public health recommendation of physical activity. A survey of female staff members over 45     years of age from the University Hospital Zurich at the end of 2003 showed that physical     inactivity is also prevalent in this population.      Aim:      To assess whether inactive women working at a large hospital centre prefer Nordic Walking     (NW) or a Jogging (J) as a health promotion strategy. (2) To test whether the method chosen     by the majority improves physical performance, physical activity, body weight and     composition, and bone mineral density.      Methods: The investigators will send out a questionnaire to all female staff members at a     large hospital centre age 45 and older, ask whether they are inactive, and whether they     prefer Nordic Walking or Jogging as a health promotion strategy. Depending on the preference     of the majority of the women, the investigators will then ask inactive female staff members     age 45+ to participate in a 12-months randomized controlled trial comparing training plus     nutrition education to nutrition education alone. The training will have a 3-month     building-up phase followed up by an in part unsupervised training of 9 months. All     participants will receive a lecture on healthy nutrition once a months for 12 months. The     investigators will assess diet with a food frequency questionnaire at baseline and after 12     and 24 months.      The primary endpoint is: physical performance, measured with the 12-minute Coopertest.      The secondary endpoints are: level of physical activity, body mass index, body composition     and bone mineral density at the spine and the hip.      Importance: This project will address the questions which physical activities are preferred     by inactive women and whether the preferred training improves physical performance, physical     activity, body mass index, body composition and bone mineral density. In addition, our study     will explore whether those women who changed their diet in addition to being randomized to     the training group have an enhanced benefit.   "
242752|NCT01033123|"     The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate     in platinum-sensitive recurrent ovarian cancer patients receiving gemcitabine and     carboplatin.      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
242753|NCT01033136|"     To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure     Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid PTSD and     panic disorder (PD) in two phases. The second phase of the study will examine the     effectiveness of MCET-V by comparing it to Cognitive Processing Therapy, a standard PTSD     treatment.   "
242754|NCT01033149|"     The specific aim of this study is to evaluate the efficacy, tolerability, and safety of     N-acetylcysteine (NAC) in the treatment on bulimia nervosa.   "
242755|NCT01033162|"     The study's aim is to provide information about the clinical and business cases for     comprehensive interactive cancer communication systems (ICCS) in the context of real world     use for cancer care.      This study will be conducted within the Kaiser Permanente Northwest (KPNW) healthcare system.     Outcomes for this study include amount of ICCS use and women's ratings of cancer information     competence, perceived social support, and emotional well being. Secondary outcomes will     include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare     visits.   "
242766|NCT01033305|"     This is a multi-center study in Ireland and United Kingdom to determine the effects, safety     and tolerability of a drug called CyCol™ in improving mild to moderate ulcerative colitis     (UC).      Informed consent will be obtained and following confirmation of eligibility and disease     assessment, study participants will be randomised (allocated by chance) to take either     CyCol™, or placebo, orally once every day for four weeks. Study visit assessments will     include blood and stool tests, physical examinations and flexible sigmoidoscopies (inspection     of the bowel wall using a flexible camera).      Half the participants will receive CyCol™ and half will receive placebo. At the end of     treatment (4 weeks) study participants will be reassessed again and the findings in those who     received CyCol™ will be compared with those who received placebo. Any side effects     experienced during the study and the safety of treatment with CyCol™ will also be evaluated.   "
242756|NCT01033175|"     Hypothesis:      The first part of the study is a survey on the prevalence of anemia of chronic disease (ACD)     among COPD patients. The 2nd and 3rd part will test 2 null hypotheses (Ho): 1.serum     inflammatory markers and plasma erythropoietin do not differ between COPD patients with and     without ACD and 2. exercise capacity does not differ between COPD patients with and without     ACD.      Rationale-Aim:      ACD is an immune driven disorder, developing in subjects suffering from chronic inflammatory     diseases. COPD is a disorder very likely to be associated to ACD due to its systemic     inflammatory dimension. Currently, data on the prevalence of ACD and on the level of     inflammatory markers which are implicated in the pathogenesis of ACD in COPD subjects are     limited and controversial. Furthermore, there is no data on the effect of ACD on exercise     capacity of COPD subjects.      Based to the aforementioned, this study has three goals:        1. to determine the prevalence and the epidemiologic characteristics of ACD in a population          of clinical stable COPD patients        2. to investigate whether the levels of serum inflammatory markers and of plasma          erythropoietin differ between COPD patients with ACD and without ACD        3. to determine potential differences regarding the aerobic exercise capacity between these          two groups, using the cardiopulmonary exercise testing (CPET).   "
242757|NCT01033188|"     There has been an increased awareness towards ACL (anterior cruciate ligament) injuries for     Norwegian teams, particularly in handball and soccer. The reported number of reconstructions     in Norway ranges from 1500 to 2000 per year, and in the United States from 50,000 to 100,000     per year, making ACL reconstruction one of the most common orthopaedic procedures performed,     especially among young, active and healthy individuals. However, reports state that there is     a subset of patients (10-40%) who remain subjectively and objectively unstable and/or are     unable to regain prior function. Additionally, it has been reported that degenerative joint     disease is associated with traditional single-bundle ACL reconstructions in up to 50% of the     patients in long term follow up studies.      It is well known that the ACL is composed of 2 functional bundles named after their tibial     attachments, the anteromedial (AM) and posterolateral (PL) bundles.      It is believed that the current single-graft, single-bundle technique for reconstructing the     anterior cruciate ligament does not anatomically reconstruct either one of these bundles.      In the last two years, the double bundle technique has been introduced and a few clinical     studies are available, however only a few RCTs.      Further study is very important to determine if double-bundle ACL reconstructions should be     performed, if single-bundle reconstructions can be adjusted to better adapt to their     biomechanical insufficiency in restoring internal rotation torques and valgus moments, and     also in trying to identify which patients might better benefit from single-bundle versus     double-bundle ACL reconstructions.   "
242758|NCT01033201|"     Lung transplantation is indicated when end-stage lung diseases no longer respond to available     standard therapy, making life expectancy short and associated with disability. Acute and     chronic rejection are common complications following transplantation, indicating screening     bronchoscopies and transbronchial biopsies at three month intervals the first two years, in     addition to clinically indicated procedures when rejection or infection is suspected.     Transbronchial biopsies carry associated risks (bleeding, pneumothorax). Chronic rejection is     characterized by progressive obliteration of distal airways (Bronchiolitis Obliterans-BO-).     BO requires open lung biopsy for diagnosis. Alternatively, a clinical surrogate     (Bronchiolitis Obliterans Syndrome), characterized by decline in Forced Expired Volume in 1     second not explained by acute rejection or infection is used for diagnosis. The new technique     of confocal endo-microscopy enables sub-surface visualization of tissue in vivo during     bronchoscopic procedures using a probe-based confocal microscope, integrated to a standard     endoscope. Bronchiolar and alveolar structures can be visualized at a cellular and nuclear     level, and these images can be saved and reviewed. This new technology could potentially     identify acute and chronic rejection, thus offering and alternative to transbronchial     biopsies. We expect to describe a new alternative to diagnose acute and chronic rejection     using confocal microscopy images obtained endoscopically, obviating complications of     transbronchial biopsies.      Endoscopic confocal endomicroscopy can detect and classify common bronchiolar and alveolar     pathological conditions in real time. Specifically, we hypothesize that confocal     endomicroscopy images of bronchiolar and alveolar structures during standard bronchoscopy     could help to recognize and classify the presence/absence of acute rejection and/or     bronchiolitis obliterans syndrome in lung transplant recipients. This technology could also     identify the histological characteristics lung diseases such as interstitial, obstructive or     vascular end stage lung diseases, and thus lead to more efficient, safer and more accurate     diagnosis of these lung conditions during routine bronchoscopies.   "
242759|NCT01033214|"     Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget     thoracic stent graft as an alternative to open surgical repair.   "
242760|NCT01033227|"     This study will determine if administration of sodium nitrite is safe and can improve small     vessel blood flow and tissue oxygenation when given as an additional treatment in patients     with acute vaso-occlusive crisis (pain crisis) associated with sickle cell disease.   "
242761|NCT01033240|"     The purpose of this study is to determine the safety and efficacy of CS-1008 in combination     with sorafenib to sorafenib alone for treating liver cancer. Approximately 160 participants     will take part in this study at approximately 22 sites (4 in the US, 8 in Japan, and 10 in     Asia).   "
242762|NCT01033253|"     The objective of this project was to evaluate a population-based, computerized tailored     intervention that addresses recommended guidelines for three target behaviors related to     obesity risk: physical activity (at least 60 minutes on at least 5 days per week), fruit and     vegetable consumption (at least 5 servings of fruits and vegetables each day), and limited TV     viewing (2 hours or less of TV each day).   "
242763|NCT01033266|"     Nasal CPAP will improve cardiopulmonary exercise test (CPET) performance in patients with     overlap syndrome(COPD and OSA). Nasal CPAP is proven to improve cardiopulmonary exercise     testing in patients with OSA. The investigators hypothesis is that patients with overlap     syndrome will have a greater improvement in their cardiopulmonary exercise testing besides a     possible improvement in their lung function test and airway resistance.   "
242764|NCT01033279|"     The purpose of this study is to determine whether self-management of oral anticoagulation     therapy with warfarin has an effect on patient's quality of life following a specific     training program led by pharmacists.   "
242765|NCT01033292|"     The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate     in platinum-resistant recurrent ovarian cancer patients receiving gemcitabine and     carboplatin.      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
242775|NCT01033422|"     This study will test the hypothesis that CF101, administered orally, will reduce intraocular     pressure in patients with ocular hypertension and/or glaucoma. Eligible patients with     elevated intraocular pressure will be evaluated and treated by ophthalmologist investigators,     and will receive either CF101 pills or placebo (dummy) pills twice daily for 16 weeks. Ocular     pressure, visual fields, and other aspects of safety and effectiveness will be monitored on a     regular basis.   "
242776|NCT01033435|"     The current study will investigate chronic hemodialysis patients who were treated in our unit     with pomegranate juice intake for 1 year - compared to a control group.      Markers will be taken 3 months after cessation of pomegranate juice intake, for inflammation     and oxidative stress and Hb A1c.   "
242777|NCT01033448|"     This open-label, multi-center study will evaluate the safety and tolerability and the effect     on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic     hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24     weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified     as slow virological responders will be enrolled in this study in order to receive additional     24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS     will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on     study treatment is 24 weeks. The target sample size is 50-150 patients.   "
242778|NCT01033461|"     The study was conducted to investigate the effect of the probiotic L. paracasei LPC 37 alone     or in combination with a calcium supplement of the human microbiota and further physiological     parameters.   "
242779|NCT01033474|"     The investigators are going to compare embryo developmental rates of human eggs following     freezing in two different freezing methods. The investigators are going to compare the     pregnancy rates following transfer to patients as well.      Null Hypothesis: The type of vitrification methodology used will not have an impact on the     following:        -  Survival rates        -  Embryonic developmental rates        -  Pregnancy and implantation rates.   "
242780|NCT01033487|"     PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease.     This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659     in patients with Chronic Obstructive Pulmonary Disease (COPD).   "
242781|NCT01033500|"     The investigators hypothesize that a calcineurin inhibitor-free, steroid-free, co-stimulatory     blockade-based immunosuppressive regimen, in combination with a GLP-1 agonist, will reduce     the islet mass required to achieve and sustain insulin independence following simultaneous     islet-kidney transplantation.   "
242782|NCT01033513|"     Many older people experience hyperlipidemia and hypertension, but, to date, there is little     information regarding whether or not medical nutrition therapy (MNT) or therapeutic meals     have an independent or joint beneficial impact on older people with these diagnoses. This     report describes a clinical trial in which the investigators directly examined these issues.     Two key clinical outcome measures include changes in diastolic blood pressure and total     fasting serum cholesterol. In addition to these clinical outcome measures the investigators     collected health related quality of life data and data that permitted cost-effectiveness     analyses.      The investigators hypothesized that MNT and therapeutic meals would each lead to lower total     fasting serum cholesterol and lower diastolic blood pressure after the 52-week trial, in     comparison to individuals who received standard support (commonly available literature on how     to manage their disease). The investigators also hypothesized that MNT plus therapeutic meals     would be especially beneficial because of their synergistic effects on the clinical outcomes.     Although the investigators established no specific hypotheses regarding the potential impact     of MNT or therapeutic meals on cost of care and quality adjusted life years, the     investigators were interested in whether MNT or therapeutic meals would be associated with     these two measures.   "
242783|NCT01033526|"     A two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel     groups study evaluating efficacy and tolerability of 800 mg Acetylsalicylic Acid (Aspirina C)     in adult patients with a common cold during a two hour in patient phase; and a follow-up     period of five days of home treatment as required.   "
242784|NCT01033539|"     The purpose of this study is to determine the effects of a sachet containing Lactobacillus     Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7,     14 and 28 days supplementation as well as 14 days wash out compared to the same sachet     without the probiotic bacteria as placebo control.   "
242785|NCT01033552|"     This is an open-label, single institution, phase II study in patients with epidermolysis     bullosa (EB). The underlying hypothesis is that the infusion of bone marrow or umbilical cord     blood from a healthy unaffected donor will correct the collagen, laminin, integrin, or plakin     deficiency and reduce the skin fragility characteristic of severe forms of EB. A secondary     hypothesis is that mesenchymal stem cells from a healthy donor will enhance the safety and     efficacy of the allogeneic hematopoietic stem cell transplant as well as serve as a source of     renewable cells for the treatment of focal areas of residual blistering.   "
242786|NCT01033565|"     The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in     4-8 year old children with autism spectrum disorders and sleep problems.   "
242787|NCT01033578|"     The aim of this study is to assess efficacy of the different adjuvant chemotherapy strategies     after hepatectomy and thrombectomy for hepatocellular carcinoma (HCC) and portal vein tumor     thrombosis( PVTT).   "
242788|NCT01033591|"     Quality of life decreases as the heart failure worsens and is one of the biggest worries of     these patients. Physical exercise has been shown as a safe intervention for people with heart     failure. Previous studies have tested heterogeneous exercise programs using different QoL     instruments and reported that the effects on QoL are inconsistent. The aim of this study is     to evaluate the effectiveness of a new exercise program for people with heart failure     (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL,     functional capacity and cardiovascular risk factor control.   "
242818|NCT01033981|"     Primary Hypothesis: The therapy with Sunitinib represents better cost-effectiveness than     IFN-α in first-line treatment for metastatic Renal Cell Carcinoma (mRCC) in Central America     and Caribbean countries   "
243353|NCT01041040|"     Prospective, multicenter, uncontrolled cohort study to analyze the efficacy of a risk adapted     treatment strategy, including gemtuzumab ozogamicin (GO) during consolidation, for patients     with acute myeloid leukemia (AML).   "
242789|NCT01033604|"     The application of Glyaderm for skin restoration intends to provide a more stable wound     closure with enhanced pliability and function of the skin and a more favourable scar. The     dermal substitute would be affordable for widespread application in full thickness skin     defects and burns.      Patients with burn wounds or large full thickness wounds will be evaluated before enrollment.     All burn wounds that are not clearly full thickness on clinical assessment will be treated     during the first 48 hours with a hydrocolloid paste and covered with a paraffin gauze     dressing. This hydrocolloid paste combined with paraffin gauze will ensure maintenance of a     moist wound environment for the first 48 hours prior to assessment by LDI and randomization.     This is the standard treatment for all burns admitted to the Ghent Burn Centre.      Wounds will be photographed on a daily basis. In order to obtain an optimal preparation for     LDI, the burn wounds will be meticulously debrided during dressing changes. LDI is most     reliable between 48-72 hours. Patients whose burn wounds meet the inclusion criteria, i.e.     full thickness burns with LDI values < 200 will be randomized to receive either GLYADERM and     split skin graft versus split skin graft alone.   "
242790|NCT01033617|"     Following myocardial infarct, cellular therapy is a potential approach to repopulate the     injured myocardium, to treat heart failure and restore cardiac function. The purpose of this     study is to assess the safety, feasibility and efficacy of intramyocardial delivery of     selected autologous CD133+ bone marrow stem cells at time of coronary artery bypass grafting     in patients with chronic ischemic cardiomyopathy.   "
242791|NCT01033630|"     Atherosclerosis (in particular stroke and heart attack) is the most important health issue in     modernized society and high blood pressure is an important predisposing factor. Hypertensive     subjects with other chronic disease such as diabetes mellitus or impaired renal function are     particularly vulnerable to these atherosclerotic complications in spite of standard     antihypertensive therapies.      Danshen and Gegen are commonly used in Chinese materia medica as treatment for cardiac     symptoms and atherosclerosis-related disorders.      The objective of this study is to test Danshen and Gegen as an cardiovascular-protective     adjunctive regimen to prevent high-risk hypertensive cohort from primary atherosclerosis.   "
242792|NCT01033643|"     This study will evaluate if MK3614, given in multiple rising doses, is safe and tolerated in     male subjects with mild to moderate hypertension.   "
242793|NCT01033656|"     An open, randomized, parallel-group, comparative, multicentre study. Patients on     corticosteroids (plus conventional therapy) will be randomized to receive anakinra     (Kineret®), or one of the following: methotrexate, azathioprine, leflunomide, cyclosporin A     or sulphasalazine. Patients enter the study if considered refractory to corticosteroids     (prednisolone equivalent ≥10 mg/day) at the time of randomization.      The randomized phase of the study will be followed by an open-label extension (OLE) phase, to     follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term     treatment with anakinra or one of the study DMARDs or a combination of study drugs for     additional 28 weeks.   "
242794|NCT01033669|"     Assessment of the inhalation profiles of four dry powder inhalers in patients with variable     degrees of lung obstruction   "
242795|NCT01033682|"     The purpose of this study is to implement and access a newly developed bladder filling     protocol for patients receiving radiotherapy for rectal cancer using imaging on the treatment     unit.   "
242796|NCT01033695|"     Endoscopic ultrasound (EUS) is an important part of the pre-treatment evaluation of patients     with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer).     When planning the optimal therapy in patients with upper gastrointestinal malignancies it is     essential to know the exact lymph node stage. Recently endoscopic sonoelastography(ES) has     been added to conventional EUS examination and may provide complementary information to     distinguish benign for malignant lymph nodes.      The N-stage relates to the treatment choice and the prognosis, and it is therefore of     particular interest to know the interobserver agreement in operator dependent techniques.     This study evaluate the interobserver agreement of EUS and ES evaluation og lymph nodes.   "
242797|NCT01033708|"     Definition of the efficacy of NET compared with treatment as usual in the treatment of     patients with complex traumatic disease (borderline personality disorder (BPD) and     posttraumatic stress disorder (PTSD)) as assessed by structured clinical interviews.     Furthermore, to evaluate the sleep, cortisol level and epigenetic differences in the process     of the specific therapy compared to treatment as usual.   "
242798|NCT01033721|"     Palomid 529 is a dual TORC1/2 inhibitor of the PI3K/Akt/mTOR pathway having broad activity in     angiogenesis and cellular proliferation. Palomid 529 will be examined to determine if the     safety, tolerability and pharmacokinetic profile of single ascending doses when administered     intravitreally or subconjunctivally.   "
242799|NCT01033734|"     This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of     intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2     years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10     doses). For patients whose conditions no longer merit continued iv dosing, therapy may be     switched to oral Tamiflu to complete their prescribed course of treatment. If medically     necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days.     Anticipated time on study treatment is 5 to 10 days.   "
242800|NCT01033747|"     The purpose of this study is to assess the safety and the effects on liver iron of     Deferasirox when given for a long treatment period in patients with transfusion dependent     iron overload.   "
242801|NCT01033760|"     The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and     Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA     levels in patients with primary HIV-1 infection.   "
242804|NCT01033799|"     This single-center, randomized, double-blind and controlled study aims to examine the effect     of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001     (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common     infectious diseases (cumulated number of infections during the intervention period: primary     criteria), and on immune functions in healthy shift workers. Volunteers received either     200g/day of tested product (N=500) or control product (N=500) for 3-months, followed by a     1-month follow-up.   "
242845|NCT01034332|"     We hypothesize that one-cycle induction chemotherapy may also help to identify     chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.   "
242805|NCT01033812|"     This pilot study is a sub-study of ATN 067. ATN 067 utilizes a cross-sectional research     design to recruit Latina and African American young women to undergo HIV screening. The     primary goal of this proposed pilot study, ATN 084, is to explore the feasibility and     acceptability of index female recruiters identifying and recruiting their past and present     male sexual partners to undergo HIV screening and complete a one-time ACASI interview. In     addition, the study will also include female friendship network members who were enrolled in     ATN 067 and were diagnosed with HIV. These young women will also be asked to recruit their     past and present male sex partners to undergo HIV screening.   "
242806|NCT01033825|"     To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous     (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.   "
242807|NCT01033838|"     Laparoscopic anterior resection is a standardized procedure requiring a small muscle split     incision to retrieve the specimen and to fashion the proximal part of the double stapled     anastomosis. Most patients can be included within a standardized perioperative care program     called Enhanced Recovery After Surgery (ERAS). A new evolution as a primary step towards a     complete Natural Orifice Translumenal Endoscopic Surgery (NOTES)-procedure is a hybrid     approach (transrectal and laparoscopic). The dissection is performed laparoscopically but the     specimen is retrieved within an endobag through the rectum. The anastomosis is created     intracorporeally using a triple stapled technique. There are no trials available in the     literature concerning these 2 techniques. Therefore this study will be undertaken to     establish the role of the 2 surgical procedures and to compare them after short-term     follow-up.   "
242808|NCT01033851|"     Current therapies for Generalized Anxiety Disorder (GAD) have limited effectiveness. This     study measures the efficacy of two different approaches to reducing anxiety and stress. One     approach uses education, nutrition, exercise, and time management training, and another uses     mindfulness meditation and yoga, which is taught as part of the Mindfulness-based stress     reduction (MBSR) course, an 8-week manualized mindfulness intervention. We hypothesize that     the two approaches will reduce anxiety in individuals with GAD in different ways. We will     measure changes in stress hormones associated with these changes.   "
242809|NCT01033864|"     This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate     sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based     therapy. On the study day patients will take their prescribed medication (either CellCept or     mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12     hours after intake of the study medication. Anticipated time on study treatment is 12 hours     and target sample size is 24.   "
242810|NCT01033877|"     The clinical trial is a phase III, double-blind, randomised, controlled, multi-centre,     clinical trial, on the immunogenicity and safety of TdaP vaccine in comparison to Td vaccine     when given as a booster vaccination to adults who were vaccinated with D, T and wP vaccine     according to the Danish vaccination programme in their childhood.      Healthy, adult, female or male volunteers, who completed primary vaccination with diphtheria     (D), tetanus (T) and whole cell pertussis vaccine (wP), typically during their childhood, is     the target population.   "
242811|NCT01033890|"     ABSTRACT      Objectives: The aim of this article is to illustrate the possibility of performing a cochlear     implant with local anesthesia and sedation, the anesthesic technique and the advantages of     that in comparison to a general anesthesia.      Materials and method: The investigators describe two successful surgeries done with local     anesthesia, including the neural telemetry and the conditions the patient presented after the     surgery, with a very good recovery and no complications during and after the procedure.      Key words: local anesthesia, cochlear implant   "
242812|NCT01033903|"     The main objective of the study is to determine if there is a difference in the number of     women with a complete miscarriage after 10 days between expectant management versus treatment     with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage     before 14 weeks and a gestational sac retained in the uterus.   "
242813|NCT01033916|"     This research study is designed to better understand post-operative complications as related     to the tightness of blood sugar control. It is also hoped that we may learn that a more     liberal control of your blood sugars is not inferior to the current strict glucose control.     Our ultimate goal is to evaluate if there is any change in the rates of complications between     the two groups. We will be comparing the current strict blood glucose control with a more     liberal target for blood sugars.   "
242814|NCT01033929|"     The primary objective is to assess the safety of two doses of C-Tb (0.01 and 0.1 µg/0.1 mL)     when administered intradermally by the Mantoux technique to patients in the acute phase of     treatment against active TB. The secondary objectives are to assess the immune response of     two doses (0.01 and 0.1 µg/0.1 mL) of C-Tb from the size of induration and to assess the     safety of unpreserved C-Tb and C-Tb preserved with 0.5% phenol (local reactions).   "
242815|NCT01033942|"     This is an exploratory mixed-methods research study that compares an efficacious behavioral     HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention     combined with a biomedical intervention (PrEP). After completing the 3MV behavioral     intervention, participants will be randomly assigned to one of three study arms: 1) daily     FTC/TDF as PrEP, 2) placebo pill control, or 3) no pill control. Behavioral and biomedical     data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who     decline to participate will be asked to complete a brief survey about their opinions on PrEP.     Qualitative interviews will be completed with six study participants and the study     coordinators at the end of the trial to explore further the issues of trial acceptability and     feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability     issues with YMSM who meet all eligibility requirements of the study except for not being age     18 or older, but are at least 16 years of age.   "
242816|NCT01033955|"     Study Design: A, multinational, double blind, placebo-controlled pilot RCT involving 80     patients in the general ICUs of 30 centres. Most patients will be recruited from within     Canada; however cases will be recruited from international sites. This study will be     conducted under the auspices of the Canadian Critical Care Trials Group (CCCTG) and the     International Forum for Acute Care Trialists (InFACT).   "
242817|NCT01033968|"     The purpose of this study is to compare the pain perception at laser treatment of peripheral     retinal degenerations with green and infrared wavelengths.   "
242819|NCT01033994|"     Osteoarthritis (OA) is one of the most common diseases affecting the joints, usually those     that are weight bearing such as the knees. OA is considered to be a disease of the cartilage     in the joints even though it involves the whole joint, including the bone and synovium (thin     lining of the joints which produces synovial fluid). With time, more and more of the     cartilage is destroyed by the disease with inflammation commonly occurring.      AS902330 is expected to increase the production and development of specific bone cells:     chondrocytes and osteoblasts (cells that produce and maintain bone and cartilage). This is     expected to lead to repair and generation of the cartilage, and a narrowing of the space     width between the knee joints in a selected region of the knee cartilage. The purpose of this     study is to see how safe treatment with AS902330 is, and to evaluate its effect on the knee     cartilage. In addition, the study will also measure the effects of AS902330 in the blood,     which reflect disease activity.   "
242820|NCT01034007|"     An initial feasibility and safety study evaluating the use of autologous tissue engineered     vascular grafts as extra cardiac total cavopulmonary connection (EC TCPC) conduits in     children with single ventricle anomalies.   "
242821|NCT01034020|"     Background:      - Many cigarette smokers claim that smoking helps them stay alert and improves their     concentration, and have reported problems in attention and concentration after quitting     smoking. Some research has indicated that nicotine can enhance certain aspects of attention     and memory in humans. However, more research is needed to determine how nicotine affects     different elements of the brain's ability to pay attention. Knowing which aspects of     attention are affected by nicotine may help produce new medications and therapies to help     people successfully stop smoking.      Objectives:        -  To investigate the dose-related effects of nicotine on the ability to pay attention in          smokers and nonsmokers.        -  To compare the effects of nicotine in smokers and nonsmokers.      Eligibility:      - Individuals between 18 and 50 years of age who are either current smokers (at least 15     cigarettes per day on average for at least 2 years) or healthy, nonsmoking volunteers.      Design:        -  The study will consist of one training session and three testing sessions. Each session          will last about 2 hours.        -  The training session will introduce participants to the study tests and evaluate their          tolerance of the two levels of nicotine nasal spray used in the study. Smokers will          receive the higher dose of nicotine to introduce them to the effects of the spray.          Nonsmokers will be given first the lower dose of the spray, followed by higher dose at          least 30 minutes later. Nonsmoking participants who cannot tolerate the higher dose will          not continue in the study.        -  At the start of each testing session, smokers will have one cigarette to standardize the          time of the most recent exposure to nicotine.        -  During the testing sessions, participants will receive a placebo spray, a lower dose of          nicotine, or a higher dose of nicotine, and then will be asked to perform tests that          evaluate mood, attention, and performance.   "
242822|NCT01034033|"     The purpose of this study is to try to understand the biology of development of breast,     ovarian, fallopian tube, peritoneal or endometrial cancer from persons at high genetic risk     for these diseases. The influence of environmental factors on cancer development in     individuals and families will be studied. The efficacy of treatments for these diseases will     be evaluated.   "
242823|NCT01034046|"     The purpose of this study is to assess the effectiveness of two different reduced calorie     diets that have different combinations of carbohydrate, fat, and protein content in 2 groups     of study participants: insulin sensitive participants and insulin resistant participants. The     hypothesis of the study is that people with high and low levels of insulin resistance may     respond differently to different diet compositions in a real-world environment using meals     that are commonly available.   "
242824|NCT01034059|"     The soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) was an established     biomarker useful for infection in non-neutropenic patients. In this study, we tested sTREM-1     in the patients with neutropenic fever. Pro-calcitonin (PCT) and C-reactive protein (CRP)     were also measured. We planned to investigate and explore the role of sTREM-1 in early     diagnosis of infection in patients with neutropenic fever.   "
242825|NCT01034072|"     The purpose of this study is to evaluate for iron overload in pediatric oncology and     transplant patients who have completed their treatment between one to ten years ago.   "
242826|NCT01034085|"     Background:        -  Some people with schizophrenia have problems with their working memory and paying          attention for extended periods. These difficulties cannot be treated with antipsychotic          medications or with many standard therapies.        -  The prevalence of cigarette smoking among individuals with schizophrenia is about three          times higher than in the general population. Research has shown that nicotine, the          addictive component found in cigarettes, can help improve attentional and working memory          performance. Researchers are interested in learning more about whether there may be an          overlap in the cognitive functions beneficially affected by nicotine and areas of          dysfunction in individuals with schizophrenia.      Objectives:        -  To evaluate the potential of transdermal nicotine to alleviate cognitive deficits in          schizophrenia, and to determine whether naturally maintained cigarette-smoking, in          comparison, is an effective self-medication.        -  To gather preliminary data on genetics that may account for individual and group          differences in the performance effects of nicotine.      Eligibility:      - Current smokers (25 or more cigarettes per week for at least 1 year) between 18 and 55     years of age who are either healthy volunteers or have been diagnosed with     schizophrenia/schizoaffective disorder.      Design:        -  The study will require five visits to the research center, with an initial screening          visit, a training session, and three test sessions. Ideally, all visits will occur 1          week apart.        -  Training session: Participants will receive training on the types of computerized          cognitive and attentional behavior tests that will be given during the active portion of          the study. Participants will also fill out questionnaires on nicotine use and other          alcohol and drug use.        -  Test sessions: Participants will be assigned to random groups and will complete tests          that assess cognitive performance (a) while maintaining their usual smoking behavior,          (b) after minimal deprivation (3.5 hours without smoking) while wearing a placebo patch,          and (c) under the influence of a standard nicotine patch. The order of these sessions          will be different for individual participants.        -  Participants will provide blood samples throughout the research study for evaluation          purposes.   "
242827|NCT01034098|"     The purpose of this study was to examine the dynamic lung volumes in obese post-menopausal     women (without hormone replacement therapy) during exercise and their correlations with     dyspnea.   "
242828|NCT01034111|"     This study will assess, over a 4-week treatment period, the safety and efficacy of the     addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who     failed to achieve glycemic control on metformin monotherapy.   "
242984|NCT01037335|"     The goal of the current study was to evaluate the analgesic efficacy of low-dose morphine     administered to the site of bone graft harvesting in patients undergoing orthopedic surgery.     In addition to short-term analgesic effects, the incidence of chronic donor site pain was     evaluated 1,3,6 m after surgery.   "
242829|NCT01034124|"     Similar to the well publicized grapefruit juice effect, ongoing studies are evaluating the     interaction potential of other dietary substances on drug disposition. This study is designed     to determine whether the mechanism underlying the enhancement of the anticoagulative effect     of warfarin by cranberry juice is due to inhibition of warfarin metabolism by the juice. A     secondary objective is to determine whether cranberry juice elicits a grapefruit juice-type     interaction with midazolam.   "
243354|NCT01041066|"     The aim of this study was to compare the efficacy of nicardipine and labetalol in attenuation     of cardiovascular responses to endotracheal intubation.   "
242830|NCT01034137|"     This randomized, double-blind, placebo-controlled study will compare the efficacy with regard     to sustained remission and safety of tocilizumab and methotrexate, in combination or as     monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be     randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate     (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or     methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample     size is 300.   "
242831|NCT01034150|"     Objective: To investigate effects of home-based somatosensory stimulation associated with     motor training on improvement in performance of the paretic upper extremity in patients in     the chronic phase after stroke.   "
242832|NCT01034163|"     The primary objective was to provide drug to ongoing patients who were receiving panobinostat     and to characterize the safety and tolerability of panobinostat in patients with HL after     achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT)     with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from     the original protocol as of an amendment. The original objective was no longer feasible with     only 41 of 367 patients randomized after the study was halted due to poor recruitment. An     amendment was written to allow patients on panobinostat to continue their treatment until     discontinuation/completion criteria were met (patients were unblinded). Therefore, the study     was completed as per this amendment. No secondary objectives were included for this trial     from the amendment; this was a change from the original protocol.   "
242833|NCT01034176|"     Our hypothesis is that 30 days of oral levofloxacin (FDA approved antibiotic) in patients     with persistent viremia (BK virus found in blood) will impair progress to BK virus induced     kidney damage by significantly decreasing or eliminating BK virus in the blood.   "
242834|NCT01034189|"     We hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent     chemoradiotherapy (TP-CCRT) as the adjunctive therapy before esophagectomy or as a definitive     CRT would improve the therapeutic efficacy of TP-CCRT in patients with loco-regional     esophageal squamous cell carcinoma (ESCC).   "
242835|NCT01034202|"     This trial is conducted in Europe. The aim of this trial is to investigate the safety,     tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of     NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers   "
242836|NCT01034215|"     Global Objective: To improve quality of life and reduce stress for breast cancer survivors.     To address the late-term and long-term effects of breast cancer treatment, as defined by the     Institute of Medicine, including chemo brain, fatigue, sleep deprivation, stress, anxiety,     depression, and PTSD.      Phase II Aims: (1) To demonstrate the clinical efficacy (i.e., improved quality of life,     stress reduction, participant satisfaction with product) of the Envision the Rhythms of     Life program and (2) to establish the technical merits of the program's distance-delivery     (videoconferencing hardware and software) and instructional technology (i.e., animations,     graphically enhanced PowerPoint instructional materials, full-color program manuals,     art-as-imagery, and audio-imagery). Envision the Rhythms of Life instructs breast cancer     survivors in the practice of individualized, emotionally supportive, and biologically     accurate imagery and consists of 5, 4-hour long, interactive classes and between-class     instructor support.      Instructional Options: Option 1 delivers the program technology (animations, PowerPoint,     manuals, art, audio-art) with instructor and participants in the same room. Option 2 delivers     the program at-a-distance, to a small group of, via videoconferencing software and camera     systems (Alaska and Seattle) to low, moderate or high bandwidth areas. Each option delivers     program three times (total of 45 participants for each option). A website portal provides all     program information and materials.      Design and Method: Program will be delivered to 135 breast cancer survivors who have     completed conventional care (surgery, radiation, IV chemotherapy) for at least six weeks.     Differences in option 1 and 2 outcomes will be compared to each other and to controls;     combined outcomes of option 1 and 2 will be compared to controls; and waitlist control     outcomes will be compared to their extended baseline. Hypothesis: Options 1 and 2 will both     produce significantly better outcomes than waitlist control group.   "
242837|NCT01034228|"     Efforts are continuing to improve the efficacy of oral rehydration solution in terms of     reducing the severity (stool volume) and duration of diarrhoea (enhancement of recovery).     Antimicrobial peptides, produced by the epithelial cells, represent an important component of     the innate immunity of all epithelial surfaces of the body including intestine. Induction of     expression of antimicrobial peptides on epithelial cell surface, may thus hasten recovery     from infectious diarrhoea. Isoleucine is an essential amino acid that is easily available and     not very expensive, and its addition to oral rehydration solution might help early clearance     of diarrhoeal pathogen by inducing secretion of antimicrobial peptide by the small intestinal     epithelial cells. Additionally, it is expected to hasten recovery from diarrhoea by     reestablishing the commensal bacteria. The aim of this pilot study is to assess if addition     of isoleucine to oral rehydration solution induces secretion of antimicrobial peptide, help     establish normal bacterial populations in the intestine, and favourably impacts the severity     and duration of diarrhoea in young children. If the results are found encouraging, a     therapeutic trial with adequate sample size would be justified.   "
242838|NCT01034241|"     The purpose of this study is to determine whether different protein diets affects glucose and     insulin metabolism and substrate partitioning.   "
242839|NCT01034254|"     This project is designed to assess the efficacy of immunizing women during pregnancy with     influenza vaccine on the health of these women during their pregnancy and for 6 months     post-partum as well as on the health of their newborn infants during the first 6 months of     life. It will be conducted in Sarlahi District in southern Nepal, a rural area where a number     of large scale randomized trials have been conducted over the past 20 years.   "
242840|NCT01034267|"     The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment     of adults with major depressive disorder.   "
242841|NCT01034280|"     The purpose of this study is to correlate phenotype and genotype of Down syndrome patients in     order to identify the biochemical reactions involved in their mental retardation and their     other phenotypic characteristics.   "
242842|NCT01034293|"     The purpose of this study is to determine the effect of feeding frequency on glucose and     insulin metabolism and substrate partitioning.   "
242843|NCT01034306|"     This trial will test the hypothesis that the administration of CF101, a novel     anti-inflammatory agent, to patients with rheumatoid arthritis and high A3AR expression at     baseline will relieve signs and symptoms of the disease.   "
242844|NCT01034319|"     This study will examine the impact diabetes genetic counseling on patient motivation and     disease prevention behaviors among subjects with pre-diabetes. Intervention subjects will be     provided with their individual diabetes genotype risk score derived from aggregating the     combined results of 37 diabetes risk-associated genetic loci. Controls will not be tested.     All subjects will be enrolled in a 12-week diabetes prevention program.   "
242846|NCT01034345|"     In contrast to calcineurin inhibitors, sirolimus is known to exert remarkable     tolerance-promoting properties in multiple animal transplant models. Whether sirolimus is     capable of enhancing tolerance-related pathways and/or promoting complete withdrawal of     immunosuppressive drugs in human transplant recipients has not been previously addressed. The     goal of the investigators study is to evaluate the effects of sirolimus on previously     identified tolerogenic pathways in humans and, indirectly, to assess the capacity of this     drug to enhance the proportion of liver recipients undergoing successful immunosuppression     weaning.   "
242847|NCT01034358|"     The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been     shown to prevent the transmission of several strains of HPV in young women. Women with     inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to     having IBD or due to immunosuppressants used to control IBD. This study will test how well     women with IBD respond to the Gardasil vaccine.   "
242848|NCT01034371|"     The one-stop hybrid coronary revascularization combines minimally invasive direct coronary     artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced     operating room equipped with radiographic capability. This study is to compare 1-year     clinical outcomes of one-stop hybrid coronary revascularization with off-pump coronary     artery bypass (OPCAB) in selected patients with multivessel coronary artery disease.   "
242849|NCT01027364|"     The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc;     to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of     prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding     episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and     participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study     were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX     (BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week);     to evaluate participants' response to treatment; to evaluate rFIXFc consumption.   "
242850|NCT01027377|"     The study is to investigate the safety, tolerability, and pharmacokinetics (the determination     of the concentration of the administered drug in blood over time) of recombinant Factor VIII     Fc fusion protein (rFVIIIFc) in previously-treated subjects with severe hemophilia A.   "
242851|NCT01027390|"     Musculoskeletal disorders are frequent among office workers especially in the neck/shoulder     area.      The hypothesis is, that specific strength training of the neck/shoulder muscles will     alleviate the pain.      The two sub-hypotheses are        1. Alleviation of pain is independent of training frequency        2. Alleviation of pain is higher following supervised training vs training with initial          instruction only   "
242852|NCT01027403|"     Despite advances in medical technology, heart failure remains a major cause of illness on a     global scale. Medical research, over recent years, has shown that adult stem cells (as     opposed to embryonic stem cells) are present in most organs of adult humans. Their exact     function is however poorly understood. An improved understanding of what these stem cells do     and how they work is essential if effective stem cell treatments are to be developed in     future.      The project seeks to examine the levels of a number of different types of stem cells in     patients with heart failure, compared to healthy volunteers. The project also aims to measure     stem cell levels in patients with heart failure at the time of a sudden worsening in their     condition and then later in the same patients following recovery.      The project entails the taking of blood samples in order to measure the stem cell levels in     the blood. The study does NOT involve any form of treatment with stem cells. Two groups of     patients will be studied; patients with heart failure and healthy volunteers.   "
242853|NCT01027416|"     This study will help to understand the interaction between the hormonal therapy Tamoxifen,     estrogen receptors and certain genes in the cancer cell. This information may eventually help     select the appropriate therapy for future patients with similar cancer.   "
242854|NCT01027429|"     This trial evaluates primary care clinic-based simplified antibiotic therapy options for     young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where     hospital referral is frequently refused by families.   "
242855|NCT01027442|"     Introduction:      The use stereolithographic (SLA) guides may provide significant benefits in simultaneous     placement of multiple implants, especially in large edentulous areas lacking anatomic     landmarks for surgical reference. Planning of the implant positions prior to surgery may     shorten the duration of the surgery spent by exploring and determining the suitable implant     location on the edentulous alveolar crest in the standard technique . Previous studies have     demonstrated the use of many SLA guide in this manner, however; most were designed to be used     as placed on the alveolar crest (bone-supported) following a flap exposure, and there was no     depth-control of the osteotomy drills. Further advances in stereolithography allowed flapless     surgeries to be performed via mucosa-supported guides (Rosenfeld, et al. 2006c, Tardieu, et     al. 2007). The use of these guides eliminates not only the time required for incision and     flap exposure but post-operative patient morbidity and discomfort may also be reduced, due to     the non-invasive nature of the procedure. The aim of this study is to investigate the     accuracy, surgical and post-operative complications and post-loading outcomes of implants     placed by the conventional and aforementioned computer-aided methods.   "
242899|NCT01034566|"     RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause     less damage to normal tissue in patients with retroperitoneal sarcoma. PURPOSE: This phase I     trial is studying the side effects and and best dose of proton beam radiation therapy in     treating patients with retroperitoneal sarcoma.   "
242900|NCT01034579|"     This study, REbif® vs Glatiramer acetate in relapsing multiple sclerosis (MS) disease -     pharmacogenetic(s) (REGARD-PGx) is a single blood sampling exploratory pharmacogenetic study     of the REGARD trial.      The aim of this trial is to provide additional data on the factors influencing interferon     (IFN) beta response.      This is a Phase 4 trial involving subjects who previously participated in the REGARD trial.     To address the trial objectives, a single visit follow-up trial will be performed during     which a blood sample will be collected.   "
243439|NCT01035125|"     The purpose of this study is to explore the effect of one week inpatient self-management     program (SMP) in patients with fibromyalgia. The SMP is delivered as group     education/activities by allied health professionals.   "
242856|NCT01027455|"     In laparoscopic (key-hole) surgery, the use of cold dry carbon dioxide gas to inflate the     abdominal cavity for the creation a clear operating field, results in damage to the cavity     lining, known as the peritoneum. This has been associated with negative effects on     post-operative recovery. Adult studies using warm humidified insufflation gas have indicated     possible decreased post-operative pain, reduced narcotic analgesia requirements, decreased     fogging of the laparoscopic camera lens, and reduced time to return to normal activities.     Cold dry gas during laparoscopic surgery also has potential to cause abnormal decrease in     body core temperature (hypothermia). This has been established by trials in adult humans and     animal models. The WARMIST study aims to investigate for whether warm humid gas insuflation     during laparoscopic removal of the appendix in children reduces intraoperative temperature     variations, post-operative pain (indicated by morphine usage and pain scores), length of     hospital stay and degree of camera lens fogging, and speed post-operative recovery compared     to using cold dry gas insufflation.   "
242857|NCT01027468|"     200 eyes with each subtype of neovascular age-related macular degeneration will be included     in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual     acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT)     will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes     (group 1) were compared to the data of eyes that had undergone prior treatment with     photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).   "
242858|NCT01027481|"     In a recent study we could show that the early retinal venous vasoconstriction after grid     photocoagulation in branch retinal vein occlusion (BRVO) is closely correlated to the visual     outcome after three months. This could be of clinical importance, because the degree of     vasoconstriction might be an early marker of treatment success, compatible with the idea that     hypoxia is the major trigger of VEGF in BRVO. The present study evaluates the response of     retinal vessel diameters to anti VEGF treatment with lucentis in patients with BRVO. This is     done in an effort to gain insight into the retinal hemodynamic consequences of anti VEGF     treatment in BRVO. The hypothesis that anti VEGF treatment is associated with a     vasoconstrictor response in retinal vessel in patients with BRVO is tested.   "
242859|NCT01027494|"     The purpose of this observational study was to evaluate the effects of a topical     fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media     through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in     the nose, and in the throat.   "
242860|NCT01027507|"     To study the postprandial alterations in hemodynamics and blood pressure in relation to     gastric emptying rate, postprandial blood glucose, plasma concentrations of insulin, satiety     in healthy subjects.   "
242861|NCT01027520|"     Participants of this study will include burns requiring skin graft to hand(s). After informed     consent, an occupational therapy evaluation will be performed. Participants will consent to     surgery, in which skin graft will be applied by physician during surgery, occupational     therapy will apply coban dressing. Participant will seen daily by occupational therapist     during hospitalization for active range of motion to hand(s). Occupational therapist will     measure range of motion of hand(s) and physician will assess graft success at one and four     days after surgery and at three out patient clinic visits. Hand strength will also be     measured at three out patient visits.      Does the initiation of range of motion on post operative day kone with coban dressing improve     hand function without compromising graft success?   "
242862|NCT01027533|"     The purpose of the study is to determine whether implantation of a multifocal IOL with a     modified addition at lens plane(Restor +3) results in better intermediate visual acuity with     similar performance at distance and near compared to other multifocal IOL with similar design     but with higher addition at lens plane. Patient's contrast sensitivity of vision and best     reading distance following Restor +3 implantation were also assessed.      Study hypothesis: the implantation of an intraocular lens (IOL) with a modified addition at     lens plane (restor +3, Alcon Laboratories,Inc) results in better intermediate visual acuity     with similar distance and near visual acuity after cataract surgery.   "
242863|NCT01027546|"     The purpose is to evaluate the efficacy of tranexamic acid in cervical laminoplasty; the     surgical procedure used was identical in all cases.   "
242864|NCT01027559|"     The overall purposes of this research are to determine if Cognitive Behavioral Therapy (CBT)     has the same healing effect on the brain for people with depression as traditional     anti-depressants do, to find out more about the causes of depression and why people differ in     the extent of problems caused by depression, and to determine if certain differences in genes     within populations are related to clinical symptoms. We hypothesize that CBT will have the     same healing effect on the brain as antidepressants; that differences in brain activations     created by the various tasks and genetic differences will help us understand differences in     the type and severity of symptoms among the depressed subjects.   "
242865|NCT01027572|"     Rationale. The investigators hypothesize that bilateral electrical central thalamic     stimulation of patients in Vegetative State and Minimally Conscious State from at least 6     months could improve the level of responsiveness.      Aims. Evaluate the efficacy of bilateral electrical central thalamic stimulation in patients     in Vegetative State and Minimally Conscious State.      Study Design. Patients in Vegetative State and Minimally Conscious State from at least 6     months because of traumatic brain injury, hypoxic or ischemic brain injury will be evaluated     to confirm the diagnosis according to the recent literature criteria. Then patients will be     investigated by magnetic resonance (MRI), EEG and evoked potentials to evaluate eligibility.     Patients included into the study will be implanted with electrodes, targeting the     centromedian/parafascicularis nucleus complex of the thalamus bilaterally.      In the following months patients will be repeatedly evaluated using the CRS-R and Coma/Near     Coma scales and the neurophysiologic parameters (EEG, evoked potentials) to assess the     effects of thalamic stimulation. fMRI,DTI and MRS will be performed prior and after thalamic     stimulation.   "
242866|NCT01027585|"     To study the effect of cinnamon on postprandial blood glucose, and plasma concentrations of     insulin in subjects with impaired glucose tolerance.   "
242867|NCT01027598|"     This randomized, placebo-controlled, Phase II trial will compare the combination of erlotinib     with pazopanib (providing concurrent EGFR and VEGFR inhibition) with erlotinib alone in the     second- or third-line treatment of patients with advanced NSCLC. This study will be conducted     though the Sarah Cannon Research Consortium, a community-based clinical trial network.   "
242868|NCT01027611|"     There are currently several different commercially available topical eye drops and gels used     to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack     is performing a research study to evaluate three commercially available topical anesthetics     (eye numbing treatments) to determine if individuals have a preference for one over the     other. The three topical anesthetics being studied are 1) 0.5% proparacaine hydrochloride     (generic, Akorn, Inc), 2) 0.5% proparacaine hydrochloride (generic, Akorn, Inc) PLUS 4%     lidocaine hydrochloride topical solution (generic, Roxane Laboratories), and 3) 3.5%     lidocaine hydrochloride ophthalmic gel (Akten, Akorn, Inc). These eye anesthetics are NOT     experimental medications. They are all commercially available topical anesthetics currently     used in our offices and their use is widespread among retina specialists throughout the     United States. Dr. Pollack will randomly select one topical anesthetic to use and he will ask     you to grade your level of pain associated with the injection procedure. Answering these     questions should take less than one minute of your time and your identity will NOT be     revealed with the results of this study. The results of this study will be used to inform     doctors which eye anesthetics patients find most effective for pain control during eye     injections.   "
242869|NCT01027624|"     This is a multi-centre survey of patients who are currently on lipid lowering pharmacological     treatment in South Africa.   "
242870|NCT01027637|"     The purpose of this study is to evaluate the role of Alloderm tissue regenerative matrix used     in many breast reconstruction operations. When this material is used in the abdomen it often     stretches and sometimes needs to be replaced. Although we see good clinical results when used     for breast reconstruction, there is no research regarding if or how the material changes in     this location. The Alloderm is placed in the breast at the time the expander is placed,     post-mastectomy. The expansion is started at the time of surgery and completed during a     series of office visit. This process stretches the skin, underlying muscle and presumably the     Alloderm. The goal of this study is to better understand the natural history of this material     when used for breast reconstruction.      Our objective is to measure changes in the dimension of the tissue matrix material after it     has been placed in the breast. These objective findings will be supplemented with a patient     questionnaire specifically designed for breast surgery patients.      All patients will receive the standard preoperative work up, intraoperative procedures, and     postoperative care indicated for patients undergoing implant breast reconstruction after     mastectomy. Some of these patients will require use of the Alloderm to reconstruct the lower     half of the breast pocket. This is already being done by plastic surgeons here at Henry Ford     Hospital. The difference will be that the Alloderm tissue matrix used to reconstruct the     lower part of the breast pocket for the study patients will have 4 millimeter metallic clips     placed in it. Postoperatively these clips will be tracked by ultrasound done in the clinic.     As the breast implant is normally expanded by adding saline, we believe the Alloderm matrix     will stretch. The movement of these imperceptible clips will be tracked and measured to map     the expansion of the matrix in response to the underlying implant stretching the overlying     breast pocket and the skin envelope. The pattern of expansion will allow us to develop a     mathematical model to describe the stretch pattern of Alloderm matrix used in breast     reconstruction. This information will be supplemented with a validated questionnaire     specifically designed by breast surgery patients. This will give us both an objective     dimensional change in the breast reconstruction as well as a patient-centered evaluation of     the reconstruction process.   "
242871|NCT01027650|"     This study will evaluate the safety and efficacy of a single intravitreal injection of     AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being     conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a     single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of     AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2     will enroll approximately 96 subjects who will receive a single masked intravitreal injection     of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.   "
242872|NCT01027663|"     The purpose of this study is to perform laboratory based studies to determine if the growth     and development of the malaria parasite is effected by iron status of its host (the person     infected with the malaria parasite). Iron deficiency affects over 500 million people     including many pregnant women and children from areas of the world that are plagued by     malaria. Some population based studies have suggested that iron deficiency protects people     from getting malaria and this has raised questions about the wisdom of public health policies     that provide universal iron supplementation in countries where malaria is common. We will use     red blood cells and sera from patients with iron deficiency anemia, hereditary     hemochromatosis and normal individuals who are taking iron supplements to look at this     question in a very systematic way. This study should provide information for or against a     possible mechanism by which iron deficiency may affect the malaria parasite. The results will     contribute to efforts to develop evidence-based public health policies on iron     supplementation policies in malaria-endemic areas.      There are three different types of individuals involved in this study (1) people with iron     deficiency anemia who will be taking iron supplementation (2) people without iron deficiency     anemia who will be taking iron supplementation and (3) people with a condition called     hereditary hemochromatosis who have an excess of iron in their bodies.   "
242873|NCT01027676|"     Gefitinib is an orally active epidermal growth factor receptor-tyrosine kinase inhibitor     (EGFR-TKI) and produces 8-20% of response rates in patients with advanced non-small cell lung     cancer (NSCLC). Vorinostat (suberoylanilide hydroxamic acid [SAHA]) is a small-molecule     inhibitor of histone deacetylase (HDAC) and induces cell differentiation, cell cycle arrest,     and apoptosis in several tumor cells. There is a strong synergistic antiproliferative effect     of vorinostat in combination with gefitinib in NSCLC cells. Vorinostat increases expression     of E-cadherin and ErbB-3, which results in increased sensitivity to gefitinib. Moreover,     In-vitro studies have shown that vorinostat leads to acetylation and disruption of Hsp90,     which may lead to decreases in activity of pro-growth and prosurvival client proteins (J Bio     Chem 2005;280:26729, Br J Cancer 2006;95:S2). These findings suggest that combination of     vorinostat with gefitinib may improve the efficacy of gefitinib in NSCLC.   "
242874|NCT01027689|"     This study tests the assumption that the bioavailability of alprazolam from a new sublingual     formulation is the same as that from an existing commercial immediate release tablet     formulation.   "
242875|NCT01027702|"     The purpose of this study is to determine the ability of a donor lymphocyte infusion (DLI)     given with methotrexate to hasten immune recovery without causing severe graft-versus-host     disease (GVHD) in recipients who have had a T-cell depleted transplant.   "
242876|NCT01027715|"     This is a prospective, randomized, single-center pilot trial of term and near term (≥ 36     weeks gestation) infants with encephalopathy or seizures comparing a EEG Seizure Treatment     Group or ESG with a Clinical Seizure Treatment Group or CSG.      The investigators hypothesize that the accurate detection and treatment of EEG seizures will     decrease the seizure burden and improve outcomes in newborn infants with seizures and/or     hypoxic-ischemic encephalopathy (HIE).   "
242877|NCT01027728|"     The purpose of this study is to evaluate the safety and tolerability of multiple oral doses     of CCX354-C at a number of dose levels in subjects with stable rheumatoid arthritis (RA).   "
242878|NCT01027741|"     The proposed study will:        1. estimate the prevalence of need for cancer screening and prevention in a population of          211 callers;        2. determine whether cancer communication interventions delivered through 211 can increase          use of breast, cervical and colon cancer screening, HPV vaccination, smoking cessation          and adoption of smoke free home policies;        3. determine how intensive an intervention is needed to bring about these changes; and        4. determine whether the effectiveness of these interventions is enhanced when callers'          basic needs have been addressed. Connecting these systems - 211, clinical and community          cancer control programs and navigation services - should benefit disadvantaged          Americans. The proposed study will evaluate the effects of this approach to eliminating          cancer disparities.      We hypothesize that the proportion of 211 callers who obtain a needed cancer control service     will:        1. differ significantly by study group as follows: N > T > P > CONTROL;        2. vary significantly across study groups based on the intervention dose callers receive;          and        3. vary significantly across study groups based on whether callers' original need was          resolved, the extent of their basic needs, and their perception of life as manageable          and predictable (i.e., sense of coherence).      (Dissemination Aim): Determine costs to 211 and effects on quality of service by offering     cancer control referrals.   "
242879|NCT01027754|"     Patients in substance abuse treatment smoke four times more than non-substance abusers, and     suffer high rates of tobacco-related disease and death. While many quit smoking treatments     exist that have been shown to help non-substance abusers quit smoking, little is known about     what treatments work for patients in substance abuse treatment. The drug varenicline     (Chantix) has been shown to be more effective at helping people quit smoking than nicotine     replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in     patients in substance abuse treatment. The study aims to evaluate the feasibility,     effectiveness and safety of varenicline, in combination with counseling, in methadone     maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol     and illicit drug use in methadone maintained smokers. We hypothesize that participants     receiving varenicline will have higher abstinence from smoking than participants receiving     placebo and that participants taking varenicline will not have significantly more adverse     reactions than were described in the general population in other studies. We also hypothesize     that compared to continued smokers, tobacco abstainers will be more likely to be abstinent     from alcohol or illicit drugs.   "
242880|NCT01027767|"     The investigators hope to prove that radiation and surgical scarring does not result in     changes that affect the MBI pattern 6-12 months after completion of treatment.   "
242881|NCT01027780|"     The purpose of the study is to better understand effects of the Mindfulness-Based     Stress-Reduction (MBSR) program on the physical and emotional health and well-being of adults     ages 65 and older.      The effects MBSR may have on the immune system is investigated, including how these effects     relate to factors such as perceived health, psychological well-being, age, personality, and     mood.   "
242882|NCT01027793|"     This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial     dermabrasion in subjects that have recent stretch marks.   "
242883|NCT01027806|"     The investigators leading hypotheses are:        -  Oral therapy with montelukast may lead to improved sleep study findings in children with          mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of          adenoids and tonsils for OSAS.        -  A significant proportion of the children with OSAS treated with montelukast will show          reduced severity of OSAS, and this will remove the need for surgical intervention.   "
242884|NCT01027819|"     The purpose of this study is to compare the clinical and radiological outcomes of     mobile-bearing with that of fixed-bearing in total knee arthroplasty.   "
242885|NCT01034384|"     Background:        -  Denicotinized cigarettes are similar to commercial cigarettes but contain and deliver          virtually no nicotine. Denicotinized cigarettes are used as a control condition in          smoking research, as a substitute treatment for nicotine dependence, and as a strategy          to reduce incidence of nicotine addiction. However, the symptoms of nicotine withdrawal          and craving for cigarettes must be minimized to ensure that smokers will continue to use          denicotinized cigarettes instead of their preferred cigarettes.        -  Although research has shown that smokers preferred cigarettes that delivered nicotine,          subjective measures of tobacco craving and withdrawal were similar after standard and          denicotinized cigarettes. This suggests that the process of smoking and non-nicotine          components of tobacco smoke mediate some of the effects of cigarette smoking. More          research is needed on the comparative physical and mental effects of regular cigarettes          and denicotinized cigarettes.      Objectives:      - To compare the effects of complete abstinence or smoking denicotinized cigarettes with     smoking nicotinized cigarettes on the following measures: (1) withdrawal symptoms and quality     of sleep, (2) hormonal responses, (3) mood and cognitive performance, and (4) functional     brain activity.      Eligibility:      - Men between 18 and 50 years of age who are either current smokers (at least 15 cigarettes     per day for at least 2 years) or nonsmoking volunteers.      Design:        -  Participants will be divided into four groups: (1) nonsmokers, (2) smokers who receive          nicotinized cigarettes, (3) smokers who receive denicotinized cigarettes, and (4)          smokers who will abstain from cigarettes.        -  The study will last 16 days. Smokers will have 14 visits to the clinical center;          nonsmokers will have 6 visits. From Day 6 to Day 14, current smokers will follow the          smoking regimen assigned by the researchers (not smoking, smoking denicotinized          cigarettes, or smoking nicotinized cigarettes).        -  Nonsmokers will have one day of training on the memory and thinking tasks that will be          performed in the functional magnetic resonance imaging (fMRI) scanner, and will have 5          additional days of two fMRI scans per day (total of 10 fMRI scans).        -  Current smokers will have 2 days of training on the memory and thinking tasks that will          be performed in the fMRI scanner, physical assessments on Day 3 and Day 6, and 5 days of          two fMRI scans per day (total of 10 fMRI scans).        -  Participants in the complete abstinence group will be asked to resume smoking after the          abstinence period and the denicotinized cigarettes group will resume nicotinized          cigarettes on day 14. Participants can decline to resume smoking, and if desired they          will be referred for smoking cessation treatment.   "
242886|NCT01034397|"     This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging     (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with     moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological     DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg     (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their     stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and     target sample size is <100.   "
242887|NCT01034410|"     This is an open label randomized controlled phase II study of AS1411 combined with Cytarabine     in the treatment of patients with primary refractory or relapsed acute myeloid leukemia.   "
242888|NCT01034423|"     The investigators want to study health effects from omega-3 fatty acids, from fishoil with     different quality.   "
242889|NCT01034436|"     The purpose of this study is to study the health effects of fatty acid quality in healthy,     overweight individuals.   "
242939|NCT01036412|"     The goal of this clinical research study is to find out if 1% chlorhexidine gluconate gel     will decrease the amount of bacteria that causes tooth decay. Whether the gel is acceptable     to patients will also be studied.   "
242890|NCT01034449|"     This program offers the opportunity to receive an allogeneic transplant to try to control the     malignant hematologic in the absence of acceptable conventional donor and with a risk-benefit     ratio equivalent to that which would be expected with a transplant from a more conventional     donor.      An economy of means in that this method could serve as an alternative to 2 units of placental     blood transplantation. The current cost of disposal of a unit of placental blood from a bank     is approximately 22000 € (Source: Biomedicine Agency, 2007 rates). The amplification process     as controlled by EFSAL is 12000 €. Therefore, buying a unit and ex-vivo amplification is     more economical. Moreover, the availability of placental blood is not infinite, and the use     of one unit per patient will also save resources that can be valuable for certain groups of     patients.      In the longer term, methods of amplification of specific immunocompetent cells (from the     fraction of CD 34 neg cells) are already being evaluated in the laboratory. They allow to     consider a faster recovery, better and more targeted, including cells against the disease for     which transplantation is performed.   "
242891|NCT01034462|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of     Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive     disorder   "
242892|NCT01034475|"     Chemotherapy resistance is a major cause of death in patients with advanced hematologic     malignancies. The proposed novel mechanism of action, non-cross resistance with     chemotherapeutic agents currently used in the clinic, and lack of CPI-613-related     myelosuppression preclinically and clinically to date make CPI-613 a suitable candidate for     phase I clinical trial in these patients. The current trial is one of several clinical trials     of CPI-613. Other clinical trials that are conducted in patients with solid tumors have     already been initiated.      The primary objective of this study is to determine the safety and MTD of CPI-613 when     administered 2x weekly for 3 consecutive weeks.      The secondary objective is to determine the PKs of CPI-613 following IV administration and to     observe the anti-tumor effects of CPI-613, if any occur.   "
242893|NCT01034488|"     1. Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is          an endogenous anticoagulant. This complex inhibits the formation of thrombin and          accelerates its destruction. In addition, heparin and ATIII inactivate other proteases          of the coagulation cascade, especially the anti-activated factor X. The outcome of these          biochemical actions is the inhibition of the formation and synthesis of activators of          the clotting factors that exert critical functions in the genesis of the blood clot.          Patients with chronic renal failure (CRF) that make use of hemodialysis need a system of          anticoagulation with direct inhibitors of thrombin and / or heparinoids to prevent          thrombosis.           Based on clinical studies, the control of plasma heparin level in patients with CRF is          essential. Coagulation tests such as APTT, PT, ChT and evidence of activity of anti-Xa          factor to be used as a substrate for protection for those patients undergoing          hemodialysis.        2. Objective: Check the non-inferiority clinical, the pharmacodynamic effect and safety in          use of the drug heparin of porcine origin, produced by the Laboratory Eurofarma, having          as the active comparator drug APP ® Heparin Sodium (heparin - APP Pharmaceuticals) in          patients with renal failure who do hemodialysis treatment.   "
242894|NCT01034501|"     The aim of this study is to verify the efficacy of Photodynamic Therapy (PDT) as an adjunct     to non-surgical treatment of chronic periodontitis by assessing clinical and microbiological     and immunological parameters. This is a randomized, controlled, double-blind, parallel     clinical trial. Thirty eight patients with chronic periodontitis will receive conventional     periodontal treatment. After eight weeks, patients will be re-evaluated and sites with     residual pockets (PD ≥ 5 mm ) will be selected as experimental sites, and will be allocated     to test and control group randomly. The test group will receive the application of PDT and     the control group will receive sham procedure. The clinical parameters will be evaluated at     baseline, 3, 6 and 12 months after treatment. Subgingival plaque will be collected before     PDT, a week after, 3, 6 and 12 months later. The microbiological evaluation will detect and     quantify periodontal pathogens such as Porphyromonas gingivalis, Tannerella forsythia,     Treponema denticola and Aggregatibacter actinomycetencomitans with real time-PCR. During     follow-up, patients will receive periodontal maintenance every 3 months, as well as the     application of PDT or sham   "
242895|NCT01034514|"     To develop and investigate a novel radiotherapy technique for preserving lung function based     on a map of lung function.   "
242896|NCT01034527|"     Females who participate in cutting and landing sports suffer anterior cruciate ligament (ACL)     injuries at a 2 to 10-fold greater rate than males participating in the same high-risk     sports. Fifty to 100 percent of ACL injured females will suffer osteoarthritis of the injured     knee within one to two decades of the injury. External knee abduction moment (LOAD) predicts     ACL injury with high sensitivity and specificity in female athletes. Control of lateral trunk     motion (LTM) also predicts ACL injury with similar levels of sensitivity and specificity in     female athletes. These predictors may be linked, as lateral positioning of the trunk can     create high knee abduction load via both biomechanical and neuromuscular mechanisms. The     mechanism of ACL injury in females include high knee LOAD and high LTM, with the majority of     body weight shifted over the injured limb and the foot positioned lateral to the body's     center of mass. An unanticipated perturbation is also often a contributor to the injury     mechanism. LTM may result in increased knee LOAD by increasing the lateral position and     magnitude of the GRF vector (ΔGRFv) or by increasing reactive hip adductor torque (HAdT). Our     long-term objectives are to determine the mechanisms that cause ACL injury in female athletes     and to develop neuromuscular training (NMT) interventions that specifically target these     mechanisms. If the objectives of this proposal are achieved, an evidence-based NMT     intervention will be developed and made available nationally that will effectively and     efficiently reduce ACL injury risk in high-risk female athletes. The major goal of this     proposal is to determine if increased LTM increases coronal plane knee load in high-risk     groups of female athletes. This application will test the central hypotheses that LTM     increases knee LOAD and that NMT that is targeted toward increasing coronal plane control of     trunk motion will decrease knee LOAD in females with moderate and high knee LOAD. Aim 1 is     designed to determine the mechanisms by which trunk motion may increase knee LOAD in female     athletes. Coronal plane control of the trunk (LTM) will be examined relative to ΔGRFv, HAdT     and knee LOAD. We will determine if increased LTM increases knee LOAD by biomechanical     (increased ΔGRFv) and/or neuromuscular (increased relative HAdT) mechanisms that may underlie     increased LOAD in female athletes. The central hypothesis of Aim 1 is that increased LTM will     increase knee LOAD in female athletes by increasing ΔGRFv, by increasing HAdT or via a     combination of these mechanisms during cutting and landing. We hypothesize that females with     neither mechanism will have low knee LOAD, those with increased ΔGRFv or HAdT will have     moderate LOAD and those with increased ΔGRFv and HAdT will have high knee LOAD. Aim 2 is     designed to determine if NMT that decreases coronal plane trunk motion will decrease knee     LOAD in knee load group clusters in a randomized controlled trial. The central hypothesis of     Aim 2 is that NMT will decrease knee LOAD in the moderate LOAD group by decreasing ΔGRFv or     HAdT and will decrease LOAD to the greatest extent in the high LOAD group by decreasing both     ΔGRFv and HAdT.   "
242897|NCT01034540|"     The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid     ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and     secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles,     in subjects with hypertriglyceridemia.   "
242898|NCT01034553|"     RATIONALE: Aurora A kinase inhibitor MLN8237 and bortezomib may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving aurora A     kinase inhibitor MLN8237 together with bortezomib and to see how well they work in treating     patients with relapsed or refractory multiple myeloma.   "
242901|NCT01034592|"     This is a single-center, single arm, open-label study of oral lenalidomide monotherapy     administered to red blood cell (RBC) transfusion dependent adult subjects with     Diamond-Blackfan Anemia (DBA).      Primary Objective: To evaluate the erythroid response rate as measured by rate of red blood     cell transfusion independence [MDS International Working Group (IWG) 2000 Criteria will be     applied].      Secondary Objective: 1)To evaluate the tolerability and safety profile of lenalidomide in     patients with DBA and other inherited marrow failure syndromes 2) To correlate response to     lenalidomide with biologic surrogates of DBA including ribosomal protein mutation status, ex     vivo erythroid colony growth, and microarray gene expression   "
242902|NCT01034605|"     Based upon an increased secretion of gastrointestinal satiety hormones (CCK, GLP-1),     PinnoThin is hypothesized to be more satiating, and to limit energy intake in humans.     Therefore, the objective of this study is to investigate whether PinnoThin leads to an     increase in satiety as determined by VAS ratings? Additionally, does PinnoThin consumed     during breakfast, in comparison to placebo, in overweight women, lead to a decrease in energy     intake during an ad libitum lunch?   "
242903|NCT01034618|"     The insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to     regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic     controls. The objective of the study is to investigate the optimal dose of such an     insulinotropic mixture.   "
242904|NCT01034631|"     The purpose of this study is to determine whether BNC105P in combination with/following     everolimus is effective in the treatment of progressive metastatic clear cell renal cell     carcinoma following prior tyrosine kinase inhibitors.   "
242905|NCT01034644|"     This study, PRISMS-15 is a single visit, exploratory pharmacogenetic trial and long-term     follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a     Subcutaneously in Multiple Sclerosis) trial.      The aim of this trial is to provide additional data on the driving factors of IFN beta     response and the long-term outcomes of Rebif® treatment.      This is a Phase IV trial involving subjects who previously participated in the PRISMS trial.     To address the trial objectives, a single visit will be performed, at least 3 months after     the onset of the last relapse.   "
242906|NCT01034657|"     This study assessed the efficacy and safety of LBH589 as single agent and in combination with     ESA in red blood cell transfusion-dependent Low and Int-1 MDS patients being either     refractory to ESA or with a low probability of response. The study had a non-randomized core     phase followed by a randomized phase.   "
242907|NCT01034670|"     To develop new methods to detect malignant and premalignant conditions of the     gastrointestinal tract.   "
242908|NCT01034683|"     The purpose of this study is to evaluate the efficacy and the toxicity of lobaplatin,     5-fluorouracil (5-FU) and leucovorin in patients with esophageal carcinoma.   "
242909|NCT01034696|"     The primary objective of this research project is to estimate the number of patients with     sarcoma or melanoma attending an outpatients clinic that are in pain or have unmet pain     needs.   "
242910|NCT01034709|"     Subjects with symptomatic CMV infection, who are enrolled in this clinical study, will be     monitored during antiviral therapy.   "
242911|NCT01035775|"     Colonoscopy is not a perfect test. It misses a substantial number of neoplastic lesions and     has some risk of missing cancer. Nearly all work on detection during colonoscopy has focused     on the withdrawal phase of the examination. This randomized, controlled trial will compare     the additional effect on the rate of adenoma detection of mucosal inspection during     colonoscope insertion, with inspection during instrument withdrawal, in patients undergoing     colonoscopy for colorectal cancer screening or surveillance.   "
242912|NCT01035788|"     The purpose of this study is to first adapt Cognitive Behavioral Conjoint Therapy for PTSD     for Operation Enduring Freedom and Operation Iraqi Freedom (OEF-OIF) Veterans diagnosed with     PTSD and their intimate partners by (1) reducing the overall length of treatment from 15     weeks to 10 weeks through the use of a weekend couple retreat to deliver the first two of     three phases of the three-phase protocol; and (2) by integrating mindfulness interventions as     a way to mitigate the short, more condensed treatment. Secondly, this study will examine the     effects of this adapted Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD     symptoms and intimate relationship functioning.   "
242913|NCT01035801|"     The purpose of this study is to see whether IN-105 (oral insulin) is able to control increase     in blood glucose after eating a meal. This study will also tell whether single tablet of     IN-105 is safe for patients with Type 1 diabetes mellitus who are currently taking insulin     injections.   "
242914|NCT01035853|"     The purpose of this study is to determine whether the nasal inhalation of Colistin is     effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.   "
242915|NCT01035879|"     To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at     three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4     weeks in patients that are treatment-naive or taking a single anti-diabetic medication     (non-TZD, non-injectable).   "
242916|NCT01035905|"     The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic     contact lens wearers when fit with one of two different daily disposable contact lenses.   "
242917|NCT01035944|"     The purpose of this study is to determine if the use of HemCon chitosan-based dressings is     effective to facilitate safe, effective debridement of chronic wounds in the operating room     and inpatient ward settings and to minimize bacterial re-colonization of wounds.   "
242940|NCT01036438|"     Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the     equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer     with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound     size reduction.   "
242918|NCT01035983|"     In this open-label, multi-center study, patients were treated with frovatriptan for a maximum     of 12 perimenstrual periods (PMPs). For each PMP, dosing commenced 2 days before the     anticipated onset of the menstrual migraine (MM) headache and continued for a total of 6     days. Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on     Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6. During the study, patients     were to visit the study site a total of 6 times. Efficacy and/or safety assessments were     performed at each visit.   "
242919|NCT01035996|"     Background:      - Schizophrenia is associated with cognitive impairment in different parts of the brain,     including those associated with learning and memory. The brain activity associated with these     impairments, however, is poorly understood. Researchers are interested in studying how the     brain chemical dopamine, which is involved in responding to incentives and rewards like money     or food, works differently in the brains of people who have schizophrenia.      Objectives:      - To study reward processing in individuals with schizophrenia who are taking different types     of medication, compared with healthy volunteers.      Eligibility:      - Individuals between 18 and 55 years of age who (a) have been diagnosed with     schizophrenia/schizoaffective disorder and are taking the antipsychotic medication clozapine,     (b), have been diagnosed with schizophrenia/schizoaffective disorder and are taking a     different second-generation antipsychotic, or (c) are healthy volunteers.      Design:        -  This study will involve one screening visit and one or more visits for testing and          functional magnetic resonance imaging (fMRI) scans. During the screening visit,          participants will complete questionnaires and provide information about their physical          and psychological health.        -  Participants will receive training in the tasks to be performed at the scanning sessions          during the screening visit.        -  During the fMRI scans, participants will complete one or two of four possible          reward-based tasks:        -  A task that enables participants to win money based on their response to a target item.        -  A task that provides small amounts of juice over specific time intervals, followed by a          procedure to be completed outside the scanner.        -  A task that involves choosing figures or shapes and winning money based on responses.        -  A game of chance involving predictions based on shapes shown on a screen.        -  Participants will also provide blood samples for research and testing.   "
242920|NCT01036009|"     There is no curative therapy once acute leukemia patients relapse after transplant. Patients     who develop clinically significant graft versus host disease (GVHD) have a lower rate of     relapse than those who do not develop GVHD. We are initiating this study of post-transplant     fast withdrawal of immunosuppression and donor lymphocyte infusions, with a goal of achieving     full donor chimerism in children with hematologic malignancies. If our hypothesis that full     donor chimerism results in leukemia-free survival is correct, using immune modulation to     achieve full donor chimerism should decrease relapse rate and thus increase survival. The     goal of this Phase II study is to identify if achieving full donor chimerism in whole blood     CD3+ and leukemia-specific (CD14/15+, CD19+, CD33+ and CD34+) subset may decrease the risk of     relapse of patients undergoing allogeneic transplant for hematologic malignancy.   "
242921|NCT01036022|"     This study is the first-time-in-patient trial of GSK1399686, a novel locally-acting     anti-inflammatory compound, aimed at obtaining initial information on the tolerability,     safety, pharmacokinetics (including concentrations in colon mucosa) and anti-inflammatory     activity of GSK1399686 upon oral dosing in patients with active ulcerative colitis.      The study is designed as a randomized, double-blind, double-dummy, placebo-controlled,     sequential dose escalating trial, with an active control (ASACOL) group as internal control.     Up to three cohorts (Cohorts 1-3), each consisting of approximately 20 patients with     mild-moderately active ulcerative colitis not limited to the rectum, will be included, one     for each dose level of GSK1399686 to be tested. Within a cohort, patients will be randomized     in a 3:1:1 ratio to receive GSK1399686 (once daily over 4 weeks, followed by 2 weeks dosing     with placebo), placebo, or ASACOL (t.i.d. for 6 weeks), respectively.      An interim analysis of fecal markers and disease activity data will be performed by the end     of Cohort 3. Based upon results, the study may be stopped or continued by recruiting either     Cohort 4 (if data on an additional dose level would be warranted to establish or clarify a     dose-response relationship) or, in the case of a robust efficacy signal at any dose level     previously studied, Cohort 5 (to expand the sample size for given dose level in order to     evaluate the efficacy of GSK1399686). The number of patients and randomization allocation     ratio may be altered in Cohort 5 and it may not include an active control arm. If Cohort 4 is     initiated upon interim analysis, then a second interim analysis may be performed at the end     of Cohort 4, to assess whether progression into Cohort 5 (as defined above) would be     justifiable.   "
242922|NCT01036035|"     THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic     agonist (pilocarpine).   "
242923|NCT01036048|"     A meta-analysis to compare outcomes of drug eluting stents (DES) versus bare metal stent     (BMS) in saphenous vein graft (SVG) disease.   "
242924|NCT01036061|"     The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and     pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.   "
242925|NCT01036074|"     Background:      - Cocaine affects the brain's ability to process information. However, different people     respond to cocaine in different ways, and differences in brain structure and function may     affect how cocaine alters brain activity. By using functional magnetic resonance imaging     (fMRI) to monitor brain activity during tasks that provide simple rewards, researchers hope     to better understand how the brain responds to rewards and how this response is affected by     drugs like cocaine.      Objectives:        -  To determine the effect of cocaine administration on the reward experience in          cocaine-dependent individuals.        -  To study genetic and personality factors that may contribute to cocaine dependence.      Eligibility:      - Individuals between 18 and 45 years of age who either are cocaine-dependent and not seeking     treatment or are healthy volunteers.      Design:        -  Participants will be asked to avoid consuming alcohol and restrict consumption of          caffeine prior to the study. Participants provide urine and breath samples to be tested          for chemicals that may interfere with the study.        -  All participants will complete a training session and at least one fMRI scanning          session. During the training session, participants will be introduced to the reward          tasks and MRI equipment.        -  Healthy volunteers will have a single fMRI session that will involve reward tasks to be          completed during the scanning. Rewards will include small amounts of fruit juice and the          opportunity to win money.        -  Cocaine-dependent participants will have a training session and three experimental          sessions including 1) a mock MRI scan to test cocaine tolerance, 2) one fMRI scan with          reward tasks after administration of IV cocaine, and 3) one fMRI scan with reward tasks          after administration of IV placebo (saline solution). Rewards will include small amounts          of fruit juice and the opportunity to win money.        -  In addition to the scans, participants will provide a blood sample for further study and          will answer questionnaires provided by the researchers.   "
242926|NCT01036087|"     The goal of this clinical research study is to learn how effective the combination of     chemotherapy including both panitumumab, Abraxane (nab-paclitaxel), and carboplatin (PNC) and     fluorouracil, epirubicin, and cyclophosphamide (FEC) used before surgery for the treatment of     IBC is. The safety of PNC combination will also be studied.   "
242927|NCT01036113|"     This is a Phase 2, multicenter, open-label, noncomparative study to evaluate safety,efficacy     and of single-agent EZN 2208 administered in patients with previously treated MBC.      After discontinuation of study treatment, patients will receive care as considered     appropriate by the investigator. Patients will continue to be followed for disease     progression, subsequent anticancer therapy, and survival.   "
246903|NCT01084135|"     The purpose of this study is to determine if short term use of rivastigmine can improve     functional abilities (for example, language, memory, and executive function) in adolescents     with Down syndrome.   "
242941|NCT01036490|"     Patients with type 2 diabetes, obesity, and chronic kidney disease are generally physically     inactive, have a high mortality rate, and may benefit from an exercise program. This study     seeks to determine if a structured exercise program will benefit the heart (improved exercise     tolerance, decreased blood pressure) and/or the kidney (decreased protein loss in urine and     stabilization of kidney function) and lead to improvements in diabetes, body composition, and     quality of life.   "
242928|NCT01036126|"     Background:      - Relapse to drug abuse often happens in the presence of stimuli that are associated with     previous drug use, also known as cues. Drug-taking behavior appears to be partly controlled     by such cues. Some research suggests that cue-induced craving states are responsible for drug     use and relapse, but other research suggests that cues can control drug taking without     conscious craving or even awareness. Researchers are interested in using functional magnetic     resonance imaging (fMRI) to study how individuals respond to drug-related cues and how these     cues affect craving on a conscious or unconscious level.      Objectives:      - To determine how drug-related stimuli (cues) affect thinking, information processing, and     body reactions in current drug users.      Eligibility:      - Individuals between 18 and 50 years of age who are dependent on either tobacco or     crack-cocaine, or are healthy volunteers who are not dependent on either drug.      Design:        -  The study will require two sessions, a training session and a testing session, that will          take place within 48 hours of each other. Between the two test sessions, participants          may not consume alcohol, tobacco, or illegal drugs, and must restrict caffeine          consumption.        -  During the first session, participants will complete questionnaires about          tobacco/cocaine use and craving, and will be trained on the tasks to be performed in the          MRI scanner.        -  During the second session, participants will perform concentration tasks and look at          pictures, some of which will be tobacco/cocaine related. Body reactions such as heart          rate, pupil dilation, and sweating will be measured during this session. Some          participants will have actual MRI scanning, while others will have mock MRI scanning.        -  After the MRI session, participants will complete questionnaires about craving and          responses to the scan.   "
242929|NCT01036139|"     To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the     long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649     in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's     Disease.   "
242930|NCT01036165|"     The purpose of this study is to test the RebiSmart™ for        -  ease of use        -  multiple domains related to subject's acceptability and satisfaction        -  reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in          subjects with RMS.   "
242931|NCT01036217|"     Background:      - The National Institute on Drug Abuse (NIDA) uses a standardized set of procedures to     develop a pool of potential participants for research studies. Because some of the data     collected during screening are used later for research, the screening itself is considered a     study. An applicant to any NIDA study is considered a participant in NIDA screening.      Objectives:      - To identify, recruit, and screen participants for NIDA research protocols.      Eligibility:      - Individuals 18 years of age and older who are able to provide informed consent.      Design:        -  Individuals who are eligible for screening will undergo two interviews: a telephone          interview and an in-person interview. The phone interview will determine eligibility for          the in-person interview.        -  The in-person interview may require up to five visits to NIDA. The in-person visit will          involve any or all of the following procedures: (1) full physical examination and          medical history; (2) psychiatric interview; (3) psychological testing; (4)          electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally          invasive procedures as directed by the research staff.        -  During screening, a photograph will be taken for confirmation of identity during          subsequent visits for other studies.        -  No clinical care will be provided as part of screening.   "
242932|NCT01036230|"     Background:        -  Environmental cues frequently induce expectancies in individuals that may strongly          influence the actual experience associated with the cue. This has both positive and          negative consequences for behavior and decision making. For instance, when an addicted          individual experiences cues associated with imminent drug taking, an expectancy of the          coming experience is also formed and very likely has an effect on the subsequent          experience of the drug.        -  Researchers are interested in studying how the brain responds to these kinds of          environmental cues and expectancies in order to learn more about addiction and craving          in substance-abusing individuals.      Objectives:        -  To compare the response to rewards (both drug-related and non-drug-related) in cocaine          users and non-using individuals.        -  To study the effect of expectation on reward-related (both drug-induced and          non-drug-induced) responses and brain activity in cocaine users and non-using          individuals.      Eligibility:      -Individuals between 18 and 45 years of age who are regular cocaine users but otherwise     healthy, or healthy individuals who are not cocaine users.      Design:        -  This study involves two experiments. Participants will be assigned to one or both          experiments.        -  Participants must not use any drugs for at least 3 days before the visit, may not          consume alcohol for 24 hours before the visit, and may not consume caffeinated beverages          for 12 hours before the visit. On the day of the visit, participants will provide both          urine and breath samples to test for drug/alcohol use.        -  Experiment 1: In the MRI scanner, participants will respond to questions and images on a          screen, and will receive small amounts of flavored liquid (chocolate or cherry) through          a tube in the mouth.        -  Experiment 2: In the MRI scanner, participants will respond to questions and images on a          screen, and will receive injections of liquid (saline solution or a drug that provides a          high similar to cocaine) through an intravenous line. Participants in this experiment          will return for follow-up visits and provide urine samples for further study.        -  The specific assignment (to Experiment 1 or Experiment 2 or both experiments) will          determine the number of study days and follow-up visits required.   "
242933|NCT01036243|"     To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter     formula containing probiotics compared to infants fed a control hydrolyzed and referenced     non-hydrolyzed formula.   "
242934|NCT01036282|"     The study is designed to evaluate the effectiveness of computerized cognitive skills training     for improving memory and problem-solving skills in inpatients with schizophrenia.   "
242935|NCT01036308|"     The objective of the conducted study was to determine the efficacy of the native legume     kernel fibres of Lupinus angustifolius Boregine (Boregine), Lupinus albus Typ Top (TypTop)     and Glycine max Hefeng (Soy fibre) on prevention of risk factors for gastrointestinal or     cardiovascular diseases.   "
242936|NCT01036321|"     The purpose of our study is to recruit and treat 96 men diagnosed with prostate cancer and     scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo     for a 3-6 week period to see if we can slow down the rate of prostate cancer growth. A     placebo is a pill or something that looks like the medicine that is being studied but has no     active medicine in it. We also want to see if taking purified isoflavones is safe and if it     reduces lower urinary tract symptoms. In addition, we want to study if purified isoflavones     are able to slow the progression of prostate cancer, and the mechanism of action of purified     isoflavones. If the safety and the effects of purified isoflavones on slowing down the     progression of prostate cancer is shown in our study, this will also be a safe way of     treating men who are at high risk of prostate cancer, so that we can prevent prostate cancer     in the future.   "
242937|NCT01036360|"     Physical activity is mainly considered and use for its impact on energy expenditure in the     treatment of obesity, and less is known concerning its indirect effects on energy intake. The     aim of this work is to clarify the impact of an acute bout of exercise, depending on its     intensity (high versus low), on the following energy intake and nutrient utilization, in     obese and non-obese boys and men.   "
242938|NCT01036399|"     Revlimid is a potent immunomodulatory analogue without the teratogenic effects, which has     direct anti-tumor effects, anti-angiogenic and both anti-inflammatory and T-cell     costimulatory properties. Both preclinical and clinical data indicate its efficacy solid     tumor and multiple myeloma including advanced/refractory stages with its role in enhancing     host antitumor immunity that provided the rationale to use in patients with PTCL.   "
242942|NCT01036516|"     Background:        -  Cues related to past drug use induce a particular pattern of brain activation, which has          been correlated with craving for cocaine in active cocaine abusers. Researchers are          interested in determining the role of the brain chemical dopamine in cue-elicited as          well as spontaneous craving for cocaine.        -  To study the role of dopamine in cocaine craving, researchers will use positron emission          tomography (PET) to compare the neural reactions of cocaine users with those of          non-substance-abusing healthy volunteers. Researchers hope that the data gathered from          this study will lead to the development of more effective anti-craving medications.      Objectives:        -  To clarify the role of dopamine in cue-elicited responses that contribute to cocaine          abuse.        -  To determine if PET results of this study differ with various means of administering PET          chemicals.      Eligibility:      - Individuals 21 to 44 years of age who are either current cocaine users (at least twice per     week) or healthy volunteers without a history of drug abuse.      Design:        -  Cocaine-using participants will enter the inpatient clinical research ward at the          National Institute on Drug Abuse (NIDA) Addiction Research Center for 2 nights before          the day of the study. In addition, these participants will stay overnight at NIDA the          evening after each PET session and will be discharged the following day. Cocaine-using          participants will be required to perform a balance test before the study to provide a          baseline response in case they require anti-anxiety medications to cope with the effects          of the study.        -  Control subjects will not be required to stay overnight and will arrive as outpatients          for the PET session. All participants will be required to abstain from alcohol and          caffeine consumption from midnight before each study session, and will not be permitted          to smoke on the day of testing.        -  - On the day of the study, participants will undergo a practice session to set up the          PET scanning equipment. Following the practice session, participants will be shown video          recordings of images that are related to nature (e.g., seashells) or to drug abuse          (e.g., drug paraphernalia). Participant reactions will be studied through the PET          monitoring, and the study will be conducted in two separate PET sessions with a break in          between. Individuals in the cocaine-using group may receive anti-anxiety medication if          the stimulus cues increase anxiety related to cocaine craving.        -  Different groups of participants will receive different methods of PET chemical          administration, and researchers will compare these methods.   "
242943|NCT01036529|"     The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness     and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as     a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as     persistent or recurrent pain following one or more lumbosacral spine surgical procedures.     Surgical procedures that can result in FBSS can be categorized as either decompression or     decompression followed by fusion with or without instrumentation. The pain of FBSS is     categorized as neuropathic, which involves pathological nerve activity and is commonly     characterized by patients as shooting or burning and/or nociceptive, which signals actual or     impending tissue damage or inflammation.   "
242944|NCT01036568|"     Background:      - Eye tracking, the ability to focus on and follow a moving target with the eyes, is often     difficult for people who have schizophrenia. Research has shown that first-degree relatives     of people with schizophrenia, such as parents and siblings, also tend to have difficulty with     smooth eye movement and eye tracking. Researchers are interested in using functional magnetic     resonance imaging (fMRI) to study brain activity during eye tracking tests in order to better     understand the effect that schizophrenia has on brain function.      Objectives:      - To study eye-tracking and eye-tracking impairments in people with and without     schizophrenia.      Eligibility:      - Individuals between 18 and 62 years of age in one of three groups: (1) patients who have     been diagnosed with schizophrenia/schizoaffective disorder, (2) first-degree relatives of     patients in group 1, and (3) healthy volunteers with no family history of psychosis.      Design:        -  The study will involve two visits, one screening session and one testing session. Each          session will take about 3 hours.        -  Participants will be asked to avoid consuming alcohol and restrict consumption of          caffeine before the start of the study. Participants will provide urine and breath          samples to be tested for chemicals that may interfere with the study.        -  Participants will visit the clinical center the morning of the day before the scanning          session to provide blood and urine samples as required. Participants will return and be          admitted for an overnight stay later that afternoon or evening.        -  During the screening session, participants will provide a medical and psychological          history, provide blood samples, and learn the eye movement tasks they will do during the          scanning session.        -  During the scanning session, participants will have an fMRI scan. During the scan, they          will perform eye movement tasks that involve following moving light targets on a screen,          and will also perform other tasks that test the ability to think and pay attention.   "
242945|NCT01036581|"     Background:      - Functional and structural magnetic resonance imaging (MRI) techniques have allowed     researchers to map and study how the brain works when at rest and when engaged in specific     tasks. MRI scans have provided more information about how drugs affect the brain, and about     how drug addiction changes the brain and influences behavior, mood, and thinking processes.     To better understand the underlying mechanism of drug addiction and to develop strategies for     more effective treatment, researchers are interested in developing new MRI techniques to     study the effects of addiction on the brain.      Objectives:      - To develop new functional and structural MRI techniques, and to evaluate their potential     use in brain imaging studies related to addiction.      Eligibility:        -  Individuals between 18 and 55 years of age.        -  Participants may be smokers or nonsmokers, and may use drugs or not use drugs.      Design:        -  During the initial screening, participants will complete questionnaires about family and          personal history, drug use, and other information as required by the researchers.          Participants who will be asked to complete tasks during the MRI scan will be shown how          to perform these tasks before the scanning session.        -  Before each study session, participants may be asked to complete some or all of the          following: questions about their drug use during the last week, a breathalyzer test, a          urine drug-use assessment, a urine pregnancy test, or a measure of carbon monoxide.          Participants will also provide blood samples before the start of the scan.        -  For each scanning session, participants will have an MRI scan that will last          approximately 2 hours.        -  MRI scans may include injections with a contrast agent to study brain function, specific          tasks to be performed during the scan, or an experiment that studies the brain's          response to carbon dioxide.   "
242946|NCT01036594|"     This is an open label, phase II, single center trial of ketoconazole/dexamethasone to     determine if the administration of ketoconazole/dexamethasone, after disease progression with     ketoconazole/hydrocortisone slows or reverses disease progression in men with progressive     prostate cancer.   "
242947|NCT01036633|"     The purpose of this study was to:        1. To investigate the feasibility of using infrared (IR) thermometer to grade the severity          of oral mucositis in patients with multiple myeloma undergoing chemotherapy.        2. To obtain preliminary data on the most optimal method of scoring the severity of oral          mucositis by comparing the results obtained using the IR thermometer to the World Health          Organization (WHO) mucositis grading system and the patient self-assessment          questionnaire.        3. To Investigate the correlation between the quantitative readings obtained from oral          mucosa with the IR thermometer.   "
242948|NCT01036646|"     This multi-center study is designed to evaluate the ability of intended lay users (patients     on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio     Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for     low sample volume and heparin insensitivity, and 2) obtain accurate results for the     quantitative determination of International Normalized Ratio (INR) when self-testing using     fingerstick capillary blood. Patients will be trained by their healthcare provider using the     instructions for use and product labeling provided. The accuracy of the patient INR results     will be assessed by comparison to the INR results obtained by the site's trained healthcare     professional using the same INRatio system (from a separate fingerstick collected from the     same patient at the point-of-care), and with the INR results obtained on venous plasma     obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560     System INR reference method.   "
243006|NCT01037634|"     Currently, there is no standard treatment for influenza with related lower respiratory tract     infection (LRTI) in children younger than one year of age, even though influenza related LRTI     is a potentially fatal illness in these children. This study will test a medicine for     influenza in children younger than one year of age to see if it is safe and effective.   "
242949|NCT01036659|"     The investigators will conduct a double-blind, randomized controlled trial comparing the     safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design     will be used such that patients failing to improve on standard therapy will additionally be     treated with ecallantide. Therefore, a historical control cohort will be enrolled for     analysis of secondary endpoints. In addition, since some patients treated with conventional     therapy may improve rapidly and therefore not be eligible for inclusion in the study, the     investigators will enroll these patients as an observational arm to enable the conduct of     sensitivity analysis.   "
242950|NCT01036685|"     Background:        -  Drugs of abuse have effects on mood, behavior, thinking, and decision making that may          encourage people to continue using them and make it difficult for them to stop.          Researchers who study these effects are interested in developing new tests to evaluate          how drugs and drug use affect different areas of the brain.        -  Magnetic resonance imaging (MRI) scans allow researchers to study brain activity and          changes to brain function. When specific psychological tests are performed during          functional MRI (fMRI) scans, researchers can examine the effects of drug use on the          brain. By developing and testing new procedures for fMRI studies, more information can          be obtained on brain function and activity in drug-using and non-drug-using individuals,          and this information can help develop new treatments and therapies for substance abuse.      Objectives:      - To evaluate the effects of newly developed psychological procedures to be performed during     fMRI scans.      Eligibility:        -  Healthy volunteers between 13 and 55 years of age who are willing to undergo MRI          scanning.        -  Both drug-using and non-drug-using individuals will be selected for this study.      Design:        -  Before the start of the study, participants will complete questionnaires about medical          and psychological history, and provide information about past or current drug use.          Researchers will introduce the tasks to be performed during the scanning session(s), and          will allow participants to practice the test either on a separate computer or on the          computer used during the MRI scan.        -  During the study, participants will be asked to do one or more tasks selected by the          researchers. The tasks will be performed on a computer in an MRI machine, and may          involve receiving rewards (such as money or sips of juice) for actions, memory and          reaction-time tests, or other tests that involve responding to instructions on the          screen.        -  Participants will receive compensation for their participation in the study, including          hourly compensation for individual visits and lump-sum compensation for each MRI scan.   "
242951|NCT01036711|"     Background:      - Many cigarette smokers claim that smoking improves their ability to think and concentrate,     and have reported problems in thinking and concentration after quitting smoking. Some     research has indicated that nicotine can enhance certain aspects of attention and memory in     humans. However, more research is needed to determine how nicotine affects different elements     of the brain s ability to think, pay attention, respond to rewards, and make decisions.     Researchers are interested in using functional magnetic resonance imaging (fMRI) to study the     effects of nicotine on brain function and activity.      Objectives:      - To determine the effects of nicotine on attentional and other thinking processes, including     reward-seeking behavior.      Eligibility:      - Individuals between 18 and 50 years of age who are either current smokers (10 or more     cigarettes per day for at least 1 year) or nonsmokers.      Design:        -  The study has four experiments. Each experiment requires two MRI scanning sessions and a          training session. Participant can do one or all of the experiments.        -  Participants will receive training on the types of computerized tests that will be given          during the active portion of the study. Participants will also fill out questionnaires          on nicotine use and other alcohol and drug use, and provide breath and urine samples.        -  During the test sessions, participants will have fMRI scanning while performing up to          four different sets of tasks that test attention, memory, concentration, reward-seeking          behavior, and decision making. Smokers will wear a nicotine patch or placebo patch          during the test sessions, but will not be told which patch they are receiving. The order          of these sessions will be different for individual participants.        -  Participants will provide blood and urine samples throughout the research study for          evaluation purposes.   "
242952|NCT01036724|"     The purpose of this study is to determine the change in median radiation exposure time and     median procedure time following guided radiofrequency (RF) ablation among subjects undergoing     treatment for paroxysmal atrial fibrillation with either the CARTO® 3 or the NavX(TM) System.      It is hypothesized that described features will reduce the median radiation exposure during     the CARTO® 3 system-guided procedures compared to the NavX(TM) system-guided procedures.   "
242953|NCT01036763|"     Documentation of successful therapy with tiotropium (Spiriva Respimat; Spiriva (tiotropium 18     mcg capsules)) in COPD patients requiring long-acting bronchodilators: description of the     most important outcome parameters according to the physicians assessment to determine the     success of therapy. Such data are not yet available.      Also collection of physicians assessments and patients assessments of efficacy and     tolerability of Spiriva Respimat, Spiriva (tiotropium 18 mcg capsules).   "
242954|NCT01036802|"     Sickle cell disease (SCD) is often referred to as a hypercoagulable state. However, the     contribution of coagulation activation to the pathogenesis of SCD remains uncertain.     Pulmonary hypertension (PHT) is a common complication associated with significant morbidity     and mortality. Autopsy studies of SCD patients with PHT show evidence of in situ thrombosis     involving pulmonary vessels, similar to findings in non-sickle cell patients with PHT.     Anticoagulation has been reported to be of benefit in non-sickle cell patients with PHT. With     the evidence of increased coagulation activation in SCD, PHT represents a clinical endpoint     that may be used to evaluate the contribution of coagulation activation to the     pathophysiology of SCD. The investigators hypothesize that increased thrombin generation, as     well as platelet activation are central to the pathophysiology of SCD and contribute to the     occurrence of several SCD-related complications, including PHT. As a consequence, treatment     modalities that down-regulate thrombin generation would be expected to delay the progression     of PHT and result in improved survival in patients with SCD.   "
242955|NCT01036841|"     Alarm-treatment as well as Desmopressin, a synthetic analogue of human vasopressin, are     considered the only evidence-based medicine (EBM) IA treatments in monosymptomatic nocturnal     enuresis (MNE). Desmopressin exists in three different formulations for ambulant use: nasal     spray, tablet and lyophilisate (MELT) each with differences in bioavailability (spray 2%,     tablet 0.2%, MELT 0.5%). There 's insufficient evidence to confirm the actually used     bioequivalent doses ( 10µg spray = 120µg MELT= 0.2mg tablet).      Although so frequently used, very few pharmacokinetic and -dynamic data on desmopressin are     available for children.      Due to prolonged half life, associated with waterintoxication,the nasal spray has a black box     warning from the FDA and is no longer recommended . For some authors oral formulations appear     to be a safer alternative. However, based on clinical experience of less response rate with     oral formulations, lower biodisponibility is suspected. Adult research confirms low     bioavailability of tablets but also show major influences by food-intake and changes in     gastro-intestinal motility.      To achieve maximum efficacy, recommendations are to take desmopressin tablet 1 hour before     bedtime and 2 hours after meal: this is unrealistic in schoolaged children since there never     is 3 hours between evening meal and bedtime.      In 2005 a dose response study demonstrated superior pharmaco-kinetic and dynamic properties     for desmopressin Lyophilisate MELT formula.      Since these results implicate superior action of MELT, often a change to MELT is recommended     if there is a suboptimal response with tablet: sublingual absorption would eliminate the     influence of food-intake.      However, for this statement there's no evidence, since these tests were all conducted in     children in fasting condition. Only one clinical study demonstrates bioequivalence for MELT     and tablet.      Hypothesis is that desmopressin MELT formulation has a better bioavailability when     administered together with meal due to its sublingual absorption.   "
242956|NCT01036854|"     The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and     Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken     on an empty stomach.   "
242969|NCT01037127|"     MEK113583 is a Phase II open-label, multi-site study to investigate the objective response     rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive     melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent     and highly selective inhibitor of MEK activation and kinase activity.   "
242957|NCT01036893|"     This is a randomized, open-label, two-way cross-over drug-drug interaction Phase I trial.      The objectives of this phase I trial are to investigate in healthy female subjects:        -  the effect of prucalopride on the absorption of ethinylestradiol and norethisterone          acetate, the active constituents of several oral contraceptives, after the first dose of          prucalopride.        -  the effect of multiple oral dosing of 2 mg prucalopride, for 6 days o.d. (steady state),          on the pharmacokinetics of ethinylestradiol and norethisterone acetate.      This trial will be conducted in healthy females of child bearing potential, i.e. females aged     between 18 and 45 years (pre-menopausal).   "
242958|NCT01036932|"     The purpose of the study is to determine whether Granulocyte Colony Stimulating factor(G-CSF)     therapy is effective in the treatment of patients with Acute on chronic liver failure(ACLF).     The investigators hypothesize that ACLF is a disease where severe hepatic impairment is     accompanied by impaired hepatic regeneration. BMC mobilization using G-CSF therapy, or G-CSF     therapy per se would increase the regenerative capacity of the liver and shall lead to     clinical, biochemical and histological improvements in patients with ACLF.   "
242959|NCT01036958|"     Background:        -  Chronic graft-vs-host disease (GVHD) is an important cause of morbidity and mortality in          patients undergoing allogeneic bone marrow transplantation. The symptoms of chronic GVHD          are similar to those of other autoimmune diseases, and treatment for the pain often          involves steroid use that can cause severe side effects over the long term.        -  At present, there is no research instrument that measures symptoms in children with          chronic GVHD. Treatment practitioners may use one of several pediatric quality of life          questionnaires, but because none of these is specific for chronic GVHD each instrument          has potential gaps in its ability to assess the full spectrum of problems experienced by          children with chronic GVHD. Researchers are interested in developing a better          understanding of the disease burden experienced by children and adolescents with chronic          GVHD.      Objectives:      - To develop a Pediatric Chronic GVHD Symptom Scale (PCSS) that reliably measures the     disease-specific burden of chronic GVHD in children.      Eligibility:      - Children and adolescents 5 to 18 years of age who have undergone prior allogeneic stem cell     transplant and have been diagnosed with chronic GVHD that requires treatment.      Design:        -  There are two phases to the study; participants will enroll in phase I (question          generation) at this time.        -  Researchers will interview participants and ask open-ended questions (requiring more          than a one- or two-word response) about symptoms that adults with chronic GVHD have          found problematic.        -  Both parents and children will participate in the interviews, which will be          audio-recorded. Depending on the child or adolescent s age, the interviews may be          conducted together with the parents or separately.        -  No treatment will be given as part of this study.   "
242960|NCT01036971|"     Background:      - The Neuroimaging Research Branch of the National Institute on Drug Abuse (NIDA) is     interested in developing a pool of potential research participants who may be eligible for     research studies on drug abuse and addiction, pharmacological and psychosocial therapies for     substance addiction, and the long-term effects of drugs on the development, function, and     structure of the brain and other organ systems. To develop this pool of potential     participants, researchers intend to screen adolescents and adults who may be eligible for     future research studies.      Objectives:      - To identify, recruit, and screen participants for NIDA neuroimaging research protocols.      Eligibility:      - Individuals 13 years of age and older who are able to provide informed consent.      Design:        -  Eligible participants will undergo two screening interviews: a telephone interview and          an in-person interview. The phone interview will determine eligibility for the in-person          interview. Adolescents who are eligible for further screening must bring a parent or          guardian with them to the in-person interview.        -  The in-person interview may require up to five visits to the NIDA clinical center. The          in-person visit will involve any or all of the following procedures: (1) full physical          examination and medical history; (2) psychiatric interview; (3) psychological testing;          (4) electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally          invasive procedures as directed by the research staff.        -  During the screening process, participants will be explicitly asked for permission to          recontact them after the 1-year duration of the screening protocol. For minors, both the          adolescent and the parent/guardian must agree to future contact.        -  No clinical care will be provided under this protocol.   "
242961|NCT01037023|"     Non-interventional, open-label, single group, multicentric post-marketing surveillance to     monitor the safety and effectiveness of Topotecan administered in Korean patients according     to the prescribing information   "
242962|NCT01037036|"     The objective of this study is to investigate how the intraocular pressure (IOP)-lowering     effect of the L-PPDS is altered by adjunctive Xalatan therapy.   "
242963|NCT01037049|"     The aim of this study is to determine whether greater rectal cancer downstaging and     regression occurs when surgery is delayed to 12 weeks after completion of     radiotherapy/chemotherapy compared to 6 weeks.      Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to     12 weeks after completion of CRT compared to 6 weeks.   "
242964|NCT01037062|"     To provide open-label entecavir to subjects who have completed previous blinded entecavir     trials in Japan and are assessed by the investigator as likely to benefit from additional     anti-hepatitis B therapy   "
242965|NCT01037075|"     Background:        -  Individuals with schizophrenia have a significantly higher tendency to develop substance          abuse or dependence than the general population. For instance, people with schizophrenia          smoke much more than the general population, and many are dependent on street drugs such          as cocaine and heroin. However, these individuals are rarely included in research          studies that might provide more information about treatments for both schizophrenia and          substance abuse.        -  Strong evidence suggests that schizophrenia and substance dependence have similar          effects on the brain, affecting attention, memory, and eye movement. Other research          indicates that schizophrenia and substance dependence affect the same parts of the          dopamine system, contributing to problems in brain function that require treatment.          These new developments provide a strong rationale to study the combination of          schizophrenia and substance dependence.        -  Nicotine may help improve brain function and thinking in individuals with both          schizophrenia and drug dependence. Some of the thinking and memory problems experienced          by these individuals can be treated with nicotine. However, more research is needed to          determine exactly how nicotine affects individuals with both schizophrenia and drug          dependence.      Objectives:        -  To determine whether individuals with schizophrenia and drug dependence show impairment          in tests of eye tracking, attention, and memory compared with healthy control subjects.        -  To evaluate the effect of nicotine on eye tracking, attention, and memory in individuals          with both schizophrenia and substance dependence.      Eligibility:      - Current smokers (at least 10 cigarettes per day for the past year) between 18 and 55 years     of age who (1) have been diagnosed with schizophrenia/schizoaffective disorder, (2) have been     diagnosed with schizophrenia/schizoaffective disorder and are currently using heroin and/or     cocaine, or (3) are healthy individuals with no family history of psychotic illness.      Design:        -  The study will consist of one training session and three testing sessions. Each session          will last about 2 hours.        -  The training session will introduce participants to the study tests and evaluate their          tolerance of the nicotine nasal spray used in the study. Participants who cannot          tolerate the higher dose of the spray will not continue in the study.        -  At the start of each testing session, smokers will have one cigarette to standardize the          time of the most recent exposure to nicotine.        -  During the testing sessions, participants will receive a placebo spray, a lower dose of          nicotine, or a higher dose of nicotine, and then will be asked to perform tests that          evaluate attention, memory, and other thinking tasks.   "
242966|NCT01037088|"     This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.   "
242967|NCT01037101|"     The study will determine the effects of D-Cycloserine (DCS) on fear reduction in patients     diagnosed with phobia of heights (acrophobia) undergoing one session of three hours of     virtual reality exposure therapy (VRET) or in vivo exposure therapy (IVET).   "
242968|NCT01037114|"     This study will evaluate the persistence of the immune response to HAV (hepatitis A virus)     antigens and HBs (hepatitis B surface) antigens in healthy adults previously vaccinated with     Twinrix™ Adult in the primary study, HAB-032 (208127/022). The subjects will be invited for     blood sampling 16, 17, 18, 19 and 20 years after the primary vaccination to evaluate the     antibody persistence. For subjects in whom low circulating antibodies are detected, the     presence of immune memory against hepatitis A & B antigens will be investigated by the     administration of a challenge dose of the appropriate vaccine (Havrix™ and/or Engerix™-B) at     the next planned visit.      No new subjects will be recruited during this study.   "
242970|NCT01037140|"     Obesity is an increasing health problem with numerous metabolic complications. Vitamin D     deficiency is common in obesity, and in epidemiological studies vitamin D deficiency has been     linked to metabolic complications, such as type 2 diabetes, insulin resistance and     cardiovascular disease, as well as myopathy, osteoporosis and depression. In obesity, a low     grade inflammation is present in the fat tissue, thereby releasing inflammatory molecules to     the blood stream. In cell line studies as well as small clinical studies vitamin D has been     shown to have the ability to reduce inflammation and cell growth.      In the present study the investigators wish to investigate the effect of vitamin D on fat-,     muscle and bone metabolism. 30 healthy obese subjects will be treated with cholecalciferol     175 micrograms daily for 6 months and will be compared with 30 healthy obese subjects treated     with placebo.      The investigators hypothesize that restoring vitamin D levels in vitamin D deficient obese     subject will reduce inflammation and thereby reduce obesity-related complications.      The effect will be evaluated as follows:        -  Levels of circulating inflammatory markers will be examined in blood samples collected          prior to and after treatment.        -  Effects on fat- and muscle metabolism will be evaluated in fat- and muscle samples taken          before and after treatment.        -  Effects on fat distribution will be evaluated by MRI scan before and after treatment.        -  Effects on insulin sensitivity will be evaluated by hyperinsulinaemic euglycaemic clamp          performed on a subgroup of subjects with impaired fasting glucose.        -  Effects on bone marrow density will be evaluated by DEXA scans before and after          treatment.        -  Effects on quality of life and depression score will be evaluated by questionnaires used          before and after treatment.   "
242971|NCT01037153|"     Background:      - Nicotine addiction is common among people who smoke tobacco, and the addictive properties     of nicotine make smoking cessation difficult even for people who want to quit. Research has     shown that smoking causes changes in the brain that lead to addiction and craving, but more     research is needed to determine how different doses of nicotine and different intervals of     receiving nicotine affect brain function. A greater understanding of nicotine's effect on the     brain, as studied through functional magnetic resonance imaging (fMRI), may improve the     effectiveness of smoking cessation therapies and treatments.      Objectives:      - To determine the effects of nicotine on brain function and chemistry in experienced     cigarette smokers.      Eligibility:      - Current smokers (at least 20 cigarettes per day for at least 1 year) between 18 and 50     years of age.      Design:        -  The study involves five separate research experiments. Most participants will be          involved in only one experiment.        -  The experiments will evaluate brain activity and function using fMRI. Participants will          be trained in a series of tests on cognitive function before beginning the experimental          part of the study.        -  Experiment 1: Participants will have three fMRI scan sessions after receiving different          dose levels of intravenous nicotine.        -  Experiment 2: Participants will have four fMRI scan sessions after receiving two doses          of nicotine separated by 1/4, 1/2, 3, and 24 hours.        -  Experiment 3: Participants will have two sets of nicotine injections separated by 45          minutes, with each injection series containing five rapid injections of small amounts of          nicotine (to mimic five puffs on a cigarette).        -  Experiment 4: Participants will have three fMRI sessions after receiving a single          injection of nicotine at three different rates (over 15, 60, or 120 seconds). In          addition there will be three more sessions involving a nicotine patch and a nicotine          injection as well as a placebo session.        -  Experiment 5: Participants will have three fMRI sessions that will involve looking at          different kinds of pictures related to or not related to smoking after receiving a          single injection of nicotine.        -  Participants will also provide blood samples for further study....   "
242972|NCT01037166|"     The objectives are to demonstrate that entecavir has antiviral activity undetectable HBV DNA     measured, the Roche AmplicorTM PCR at Week 48, and to assess the safety and the     pharmacokinetic of entecavir in Japanese patients with hepatitis B who have an incomplete     response to current lamivudine therapy   "
242973|NCT01037179|"     The objective of this study is to assess safety and efficacy of long-term use of AL-4943A     (Olopatadine Hydrochloride Ophthalmic Solution, 0.2%) in patients with allergic     conjunctivitis.   "
242974|NCT01037192|"     Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h)     administration provides non-inferior clinical efficacy and microbiological efficacy to     standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in     an outpatient setting.   "
242975|NCT01037205|"     This protocol will seek to enroll adult otherwise healthy subjects presenting with     influenza-like illness (ILI). Subjects will enter the study based on listed     inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV).   "
242976|NCT01037218|"     Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the     safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of     PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).   "
242977|NCT01037231|"     The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering     urinary oxalate levels in patients with primary hyperoxaluria.   "
242978|NCT01037244|"     Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the     safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of     PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).   "
242979|NCT01037270|"     This is a multi-center study designed to evaluate the accuracy and precision of the INRatio®     Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for     low sample volume and heparin insensitivity, when used by trained medical professionals for     the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick     and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results     will be compared to those PT/INR results obtained on plasma from the same subjects as     analyzed at a central laboratory with the Sysmex CA-560 System.   "
242980|NCT01037283|"     In patients with bipolar disorder referred for psychotherapy, is interpersonal and social     rhythm therapy delivered in a group psychotherapy format over 2-3 weeks feasible? This     project will help determine if interpersonal social rhythm therapy can be delivered in the     programmatic format being considered for the outpatient mood program.   "
242981|NCT01037296|"     Atrial fibrillation (AF) affects as many as 1 in 100 people and reduces the quality of life     of large numbers of people in the UK and around the world. Catheter ablation is a minimally     invasive treatment that has been developed to help eliminate AF. It is a complex procedure to     perform so only a few hospitals are able to offer this treatment in the UK. A new technology     allows the operator to guide their catheters (thin wires) in the patient by using a     robotically steered sheath. This allows accurate and precise navigation that may improve the     accuracy and integrity of ablation. We aim to prove whether this technology can make AF     ablation easier and more effective.      Substudy: Platelet reactivity and activation in AF, and the impact of curative ablation.     Blood and urine samples will be taken pre- and 3 months post ablation to see if platelet     reactivity and activation are affected by AF compared to established normal ranges, and     whether curative ablation impacts on this.   "
242982|NCT01037309|"     The purpose of this study is to see whether PRO044 is safe and effective to use as medication     for DMD patients with a mutation around location 44 in the DNA for the dystrophin protein.   "
242983|NCT01037322|"     There are many anecdotal reports about improvement of Inflammatory bowel diseases (IBD) with     cannabis smoking. The most effective anti inflammatory compound known today is cannabidiol.     cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat     soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side     effects.      The aim of the proposed study is to examine in a double blind placebo controlled fashion the     effect of cannabidiol on disease activity in patients with IBD.   "
242985|NCT01037348|"     This study is designed to provide efficacy and safety data in patients with choroidal     neovascularisation (CNV) secondary to myopia using an individualized as-needed (PRN) dosing     schedule. Eligible patients who have provided written agreement to take part in the study     will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. Following     eye examinations and tests at monthly clinic visits, the study doctor will repeat the     injections on a monthly basis as required for an additional 11 months, in accordance with     specified retreatment criteria.      Patients will be in the study for approximately 12 months and will visit the hospital clinic     14 times over that period. The main assessments will include visual acuity tests, eye     examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus     photography and fluorescein angiography (FA), measurement of intraocular pressure, blood     pressure and pulse measurements and completion of health-related questionnaires'.   "
242986|NCT01037361|"     Background:        -  Motor stereotypies are a movement disorder characterized by involuntary, repetitive, and          rhythmic movements. These movements have a predictable pattern and seem purposeful, but          they serve no obvious function, tend to be prolonged, and can be suppressed. Common          examples of motor stereotypies include hand waving, head nodding, and body rocking.        -  Researchers are interested in learning more about motor stereotypies. Many children with          autism and other developmental disorders tend to exhibit these behaviors, but normal          healthy children and even some adults have demonstrated motor stereotypies under certain          conditions (including boredom and stress). More research is needed to determine the          internal causes of and potential successful treatments for these behaviors.      Objectives:      - To use electroencephalography (EEG) to study cerebral activity related to stereotypies in     children.      Eligibility:      - Children between 7 and 18 years of age who demonstrate stereotypy movements on a consistent     basis (at least 10 times a day for at least 4 months).      Design:        -  The study will require two visits to the National Institutes of Health Clinical Center.        -  First visit: Outpatient screening visit to determine the child s eligibility for the          study, including questionnaires for parents/guardians and a medical assessment of the          stereotypies.        -  Second visit: Participating children will spend 1 day in a room at the NIH Clinical          Center Pediatric Day Hospital. During the visit, participants will wear a portable EEG          unit to measure brain activity. For the first hour of the visit, researchers will          perform movement tests to study the brain activity related to normal movements. For the          rest of the day, participants may play games, watch television or movies, read, or nap,          while continuing to wear the EEG to monitor brain activity related to the stereotypic          movements.        -  Participants will receive a small amount of compensation for their time and          participation.   "
242987|NCT01037374|"     The purpose of this study is to see if our experimental preoperative airway assessment form     is a better indicator of difficult airway as compared to the anesthesia record that is     presently used.   "
242988|NCT01037387|"     Parallel, randomized and controlled clinical trial to evaluate the effect of 12 months of     noninvasive mechanical ventilation versus conventional treatment in hypercapnic patients with     stable COPD.      Main objective: To evaluate the effect of 12 months of noninvasive ventilation on c-reactive     protein concentration and daily physical activity in hypercapnic patients with stable COPD.      Secondary objectives: To compare the plasmatic concentration of other inflammatory biomarkers     between COPD patients with conventional treatment and wich noninvasive ventilation. To     determine the response of breathlessness, health-related quality of life and lung function to     noninvasive ventilation. To identify the COPD patients with a higher gasometric and clinic     response to noninvasive ventilation.   "
242989|NCT01037400|"     This study will examine the magnitude and time course of changes in circulating (serum and     plasma) biomarker concentrations associated with musculoskeletal injury created by total knee     replacement surgery. The sensitivity to injury will be characterized by the changes in mean     serum concentration before and after surgery. Specificity for the injured state will be     evaluated comparing the baseline to peak change (injury response) with the pre-surgery to     follow-up baseline fluctuation (i.e. measurement noise).   "
242990|NCT01037413|"     The study will investigate the ability of EXC 001 to improve the appearance of scars in     subjects undergoing revision of scars resulting from prior breast surgery. The study will     also evaluate the safety and tolerability of EXC 001 and placebo.   "
242991|NCT01037426|"     The purpose of this study is to document the number of falls and fractures in Sinus Node     Disease (SND) patients.   "
242992|NCT01037452|"     This study will investigate the safety and efficacy of an antacid/Lansoprazole combination     product for the relief of heartburn after consuming a heartburn-inducing meal.   "
242993|NCT01037465|"     The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm     and thrombosis by producing nitric oxide and other regulatory substances. In patients with     atherosclerosis, endothelial function is impaired. Excess production of reactive oxygen     species (free radicals) contribute to endothelial dysfunction in atherosclerosis, and some     prior studies have shown a beneficial effect of antioxidant treatment on endothelial function     in patients with coronary artery disease. On the other hand, reactive oxygen species may be     required for normal endothelial function and antioxidant supplements failed to show a benefit     in large clinical trials. The effect of antioxidant treatment on endothelial function in     healthy subjects is unknown. The present study will test the hypothesis that scavenging     reactive species might reduce endothelium-dependent vasodilation in healthy subjects.      The study is a randomized, double-blind, placebo-controlled crossover study. Participants     will receive 2.4 grams of oral NAC or similar-appearing placebo during the first visit, and     then will cross over to the alternative treatment (NAC or placebo) for the second and final     visit. We will examine endothelial function before and after treatment on each visit.   "
242994|NCT01037478|"     The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe     in the treatment of relapsed or refractory Hodgkin's Lymphoma.   "
243004|NCT01037608|"     Background:        -  The therapeutic modalities of cannabis have received more research attention recently          with the discovery of its ability to stimulate appetite and to provide pain and nausea          relief in patients with AIDS, cancer, and multiple sclerosis, among other diseases.          Sativex(Registered Trademark), an experimental drug derived from the marijuana plant,          contains tetrahydrocannabinol (THC) and cannabidiol (CBD), both of which affect brain          activity. Sativex(Registered Trademark) is being tested to determine how and to what          extent it affects brain activity.        -  Functional magnetic resonance imaging (fMRI) uses magnetic waves to study brain          activity. Researchers are interested in using fMRI to study how Sativex(Registered          Trademark) affects regional brain activity, including thinking abilities and behavior.      Objectives:        -  To study changes in regional brain activity produced by Sativex(Registered Trademark)          compared with THC and placebo.        -  To determine how Sativex(Registered Trademark) is processed by the body.      Eligibility:      - Individuals between 18 and 45 years of age who are either current users of cannabis (less     than daily) or healthy volunteers who do not use cannabis.      Design:        -  The study will involve one training session and five testing sessions on separate days.        -  At every session, subjects will receive either THC or placebo capsules and either          Sativex(Registered Trademark) or placebo spray.        -  Participants will complete a training session in a mock fMRI scanner to adapt to the          fMRI scanning environment. In the training session, participants will practice the tests          that will track thinking ability, attention, working memory, and other cognitive tasks.        -  Participants will have five fMRI scanning sessions with the tests they have practiced          previously, and will provide blood, urine, and saliva samples as required by the          researchers. Participants will be discharged approximately 12 hours after they arrive          for the study sessions....   "
242995|NCT01037491|"     Clopidogrel causes significantly less peptic ulcer disease (PUD) and ulcer bleeding than     low-dose aspirin in general population. However, clopidogrel is not safe enough for     gastrointestinal (GI) mucosa in patients who had past history of aspirin-associated ulcer or     ulcer bleeding. Aspirin plus proton pump inhibitor (PPI) is superior to clopidogrel alone in     preventing recurrent ulcer bleeding in these high risk patients.      This study is to compare the ulcer healing rate and ulcer bleeding at 12 weeks in patients     with aspirin-associated PUD when they take PPI (rabeprazole 20 mg/day) to treat their PUD and     simultaneously take aspirin or clopidogrel for their cardiovascular (CV) prevention. Two     hundred patients will be randomly assigned rabeprazole (20 mg/day) plus aspirin (100 mg/day)     or rabeprazole (20 mg/day) plus clopidogrel (75 mg/day) for 12 weeks. The primary end point     is treatment success (ulcer healing rate). The secondary end point is incidence of ulcer     bleeding within 12 weeks.      If rabeprazole plus aspirin in not inferior to rabeprazole plus clopidogrel in the incidence     of ulcer healing and ulcer bleeding in the healing phase,PPI plus aspirin rather than PPI     plus clopidogrel will be recommended during acute ulcer healing in patients who need     antiplatelet therapy for their CV prevention.   "
242996|NCT01037504|"     The aim of the study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male     and female subjects   "
242997|NCT01037517|"     Poor mobilization of hematopoietic progenitors needed to support autologous transplantation     is a serious clinical problem. We are investigating the role of plerixafor administered in an     at risk population to augment successful stem cell collection.      OBJECTIVES      To determine if plerixafor when administered on the day prior to planned autologous     collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L     will:        -  increase the number of patients successfully collected in one day        -  increase the number of patients successfully mobilized on first collection attempt        -  is cost neutral within a Canadian setting   "
242998|NCT01037530|"     The investigators are conducting a randomised controlled trial to investigate the clinical     and cost effectiveness of Ramipril which is an anti-hypertensive medication in patients with     intermittent claudication. The investigators aim to recruit 78 participants in total. The     investigators will randomise the 78 participants into two groups: Ramipril group with 39     participants and Placebo group with 39 participants. The investigators will measure     Ramipril's effect on walking by doing a simple treadmill test and measuring the maximum     walking distance the participant can walk. The investigators also want to examine Ramipril's     effect on arterial function, cardiovascular prognosis, quality of life and cost     effectiveness.   "
242999|NCT01037543|"     Study Design        -  Randomized, double-blind, placebo-controlled, escalating single-dose design.        -  Six ascending dose cohorts        -  In each cohorts, subjects will be randomized to receive a single dose of HM10460A,          placebo (negative control), or Neulasta® (positive control).        -  Primary Objective        -  to assess the safety and tolerability of single escalating subcutaneous doses of          HM10460A in healthy adult Japanese and Caucasian subjects.   "
243000|NCT01037556|"     The current understanding of PR104 justifies the evaluation of PR104 in subjects with     relapsed/refractory AML and ALL. These include:        -  Hypoxia. Leukemic bone marrow is likely to demonstrate a level of hypoxia sufficient to          activate PR104 to its active metabolites PR104H and PR104M.        -  Myelotoxicity as the primary toxicity at MTD. In prior clinical studies in subjects with          solid tumors PR104 has demonstrated myelotoxicity as the primary toxicity. This          observation suggests that PR104 will exert a similar effect on leukemic cells.        -  AKR1C3. AML has been reported to exhibit high levels of AKR1C3 which should lead to          selective activation of PR104 within both hypoxic and oxic leukemic cells.        -  Preclinical data. PR104 has demonstrated impressive activity in an initial study using          primary human ALL in a mouse model.      The initial dose finding phase of the study will provide estimates of the activity and     toxicity of PR104 in subjects with refractory/relapsed AML, and determine the optimal     individualized dose to give each subject based on his/her covariates (prior CR duration,     prior number of salvage therapies, age). Once a potentially beneficial dose has been     determined, an expanded cohort of subjects with AML or ALL will receive PR104 at a uniform     dose. This information will prove valuable in defining the future clinical development of     PR104, and in determining if PR104 has sufficient activity and acceptable safety in AML to     warrant future phase II or phase III studies in this indication.      Primary objectives        -  Determine the toxicities and recommended dose of PR104 when administered IV to subjects          with relapsed/refractory AML and ALL.      Secondary objectives        -  Evaluate the pharmacokinetics (PK) of PR104 and a series of PR104 metabolites        -  Evaluate any anti-tumor effects of PR104        -  Evaluate the expression of AKR1C3 in bone marrow and leukemic cells        -  Evaluate potential biomarkers of hypoxia   "
243001|NCT01037569|"     Background:        -  Children who enter the foster care system are all too often exposed to illicit drugs in          the home. Children from these homes, known as drug endangered children, are not          routinely tested for harmful substances. Any short- and long-term physical or          developmental problems they may experience as a result of this exposure often go          undetected and untreated.        -  Children who are placed into protective custody are not always screened by physicians or          nurse practitioners. Although drug-endangered children under 18 years of age          automatically receive a urine toxicology screen to determine the types and levels of          illicit drugs in their systems, this procedure has difficulties and limitations that may          affect the quality of the data. Researchers are interested in developing more effective          methods of analyzing the presence or absence of illicit environmental drug exposure in          children.      Objectives:      - To determine the most effective method of identifying long-term illicit stimulant drug     exposure in drug-endangered children.      Eligibility:      - Children under 18 years of age who are being placed into protective custody after having     been found in a home where drugs are manufactured, used, or sold.      Design:        -  Researchers will gain verbal consent for the procedure for children who are 7 years of          age or older. Children younger than 7 years of age will not be required to give verbal          consent for sample collection.        -  Researchers will collect standard urine samples for toxicological screening. Part of the          sample will be sent to the National Institute on Drug Abuse for evaluation; the rest          will remain with the local authority.        -  In addition to this standard procedure, researchers will collect a hair sample by          cutting a small amount of hair from the crown of the head as close to the root as          possible (and not pulling any hair out of the child's head).        -  Researchers will also use an oral swab to collect a saliva sample from the inside cheek          of each child.        -  No clinical care will be provided under this protocol....   "
243002|NCT01037582|"     This trial is conducted in Europe. The aim of this trial is to investigate the safety,     tolerability and bioavailability (exploring absorption of drug in body) of NN9924 in healthy     male subjects.   "
243003|NCT01037595|"     The purpose of this study is to see whether turmeric can be effective in treatment of     pruritus in hemodialysis patients.   "
243005|NCT01037621|"     This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and     herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching     placebo. After receiving the initial therapy for eight weeks, the participants will cross     over to the alternate therapy for an additional eight weeks. Each treatment period will be     separated by a two-week period of daily placebo. The hypothesis is that treatment with     valacyclovir will result in a significant reduction in serum levels of hepatitis C virus     ribonucleic acid.   "
243182|NCT01031758|"     The purpose of this study is to investigate the use of radiolabeled particulate cholesterol     administered intravenously in association with albumin, as a method to study reverse     cholesterol transport (RCT) in humans by analyzing changes in the tracer activity in total     plasma, lipoproteins and feces.   "
243007|NCT01037647|"     Type 2 diabetes is associated with diabetic dyslipidemia, which is a major risk factor for     coronary heart disease. Triglycerides (TG) and cholesterol are transported in the system of     lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. Evidence     suggests that increased concentration of very low-density lipoprotein triglyceride (VLDL-TG)     is a central pathophysiological feature of the lipid and lipoprotein abnormalities in     diabetic dyslipidemia.      The objective of this study was to investigate VLDL-TG kinetics and aspects of peripheral     VLDL-TG metabolism, i.e. to what extent VLDL-TG associated fatty acids (FA) are oxidized or     deposited in regional adipose tissue, in subjects with type 2 diabetes and healthy controls     in the postabsorptive state and during acute hyperinsulinemia using ex-vivo labeled VLDL-TG     tracers.   "
243008|NCT01037660|"     Eating a diet high in fat contributes to the development of atherosclerosis (hardening of the     arteries). Acute fat consumption increases levels of fat in the blood and temporarily reduces     the ability of blood vessel to dilate (open up to carry additional blood). A similar response     is observed during infusion of Intra-Lipid (a fat emulsion used for intravenous nutrition).     The present study is designed to help us understand the effects of a fat load on blood vessel     function. We will measure arterial dilation using non-invasive techniques before and at the     end of a 5-hour infusion of Intra-Lipid in healthy subjects. Subjects will then take the     approved drug metformin for two weeks and return for repeat studies of endothelial function     with Intra-Lipid infusion. We expect that metformin will help preserve the normal function of     blood vessels during a fat load. This study will help us understand how fat affects blood     vessels and therefore will advance our knowledge of the development of atherosclerosis and     potentially lead to improved methods to prevent and treat heart disease.   "
243009|NCT01037673|"     Objective:      A randomized clinical trial in order to evaluate the efficacy of structured eccentric     exercises tutored by a physical therapist (PT) for patients with subacromial impingement.      Hypothesis:      H1 The exercises has a satisfactory effect and the need of an arthroscopic subacromial     decompression can be reconsidered.      H0 No difference between the two exercises (experimental and active control) and the patients     still need surgery      Further the study objective is to evaluate predictors for a positive or negative treatment     response after three months of rehabilitation as well as after 12 months.      Method:      Patients referred to the orthopedic unit for an arthroscopic subacromial decompression, are     offered a three month rehabilitation program during the waiting time for surgery which is     approximately 4-6 months. All patients must have tried conservative treatments for at least 6     months in primary care with unsatisfactory results. The patients will be randomized to either     the structured eccentric exercises tutored by a physical therapist or control exercises with     general movements for the neck and shoulders. All patients has an equal number of sessions     with the PT to offer similar attention. After three months the following key-question has to     be answered: due to your current experience of your shoulder problems do you still need this     surgical intervention? A blinded orthopedic surgeon evaluates the following outcomes at     baseline and after three and twelve months. Primary outcomes: Constant-Murley shoulder     assessment, Disabilities of the Arm Shoulder and Hans and different aspects of pain.     Secondary outcomes; EQ-5D, sick-leave and return to work. All patients are evaluated with a     diagnostic ultrasound in order to reveal the condition of the rotator cuff. Also long-term     results in those who go thorough with the surgery and those who decline will be assessed     after 12 months.      Importance of the study results:      Since there is no consensus about which intervention that should be preferred for patients     with subacromial impingement the results of the current study is warranted. If this exercise     program is successful it can be implemented into clinical practice. Further, clinical     characteristics of patients that really need an arthroscopic subacromial decompression can be     identified.   "
243010|NCT01037686|"     The goal of this study is to explore the effect of subthalamic nucleus (STN)-DBS surgery and     stimulation in PD (Parkinson's disease) patients on regional cerebral blood (CBF) flow during     cognitive task performance or at rest.   "
243011|NCT01037699|"     To analyse the impact on cycle outcome of LH supplementation in ovarian stimulation     controlled with a GnRH antagonist in two ages groups: patients upto 35 years old, and     patients aged between 36 and 39 years old.   "
243012|NCT01037712|"     The infection with cytomegalovirus (CMV) is the first cause of congenital neurological     handicap of infectious origin. It is probable that the neonatal viral load is correlated with     becoming of infected new-born babies. Among the active antiviral treatments against CMV,     valacyclovir is the only whose fetal and maternal tolerance was evaluated during the     pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to     evaluate it in a study against placebo. Decrease the fetal viral load could make possible to     decrease symptomatology neonatal in a group of infected fetuses.   "
243013|NCT01037725|"     The main purpose of this study is to assess the safety and tolerability of AZD5847 after     receiving oral doses on a single day (Part A) or after receiving a single oral dose in two     periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also     be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its     metabolites in blood and urine.   "
243014|NCT01037738|"     Abstract      Background      Pro-inflammatory cytokines play a pivotal role in osteoarthritis, as well as in bone tunnel     widening after ACL reconstructive surgery. A new treatment option is to administer autologous     conditioned serum (ACS) containing endogenous anti-inflammatory cytokines including IL-1Ra     and growth factors (IGF-1, PDGF and TGF-ß1, among others) in the liquid blood phase.      Objective The purpose of this trial was to establish whether the osteoclastic effect could be     affected by intra-articular application of ACS, thus resulting in a potential decrease of     knee laxity and leading to a better postoperative outcome.      Methods In a prospective, randomized, double-blinded, placebo-controlled trial with two     parallel groups, 62 patients were treated. Bone tunnel width was measured by CT scans, while     clinical efficacy was assessed by patient-administered outcome instruments (WOMAC, IKDC 2000)     up to one year following the ACL reconstruction in patients receiving either ACS (Group A) or     placebo (Group B). The investigators compared the levels and dynamics of IL-1b concentrations     in the synovial liquid and examined the correlation between the levels of IL-1b at three     different post-operative points.      Level of evidence Therapeutic study, Level 1 (randomized controlled trial [significant     differences and narrow confidence intervals])   "
243027|NCT01037907|"     To determine the efficacy and safety of an oral drug (BGC20-0134) in patients with relapsing     remitting multiple sclerosis. Specifically, the cumulative number of new gadolinium enhancing     lesions after 24 weeks of treatment with BGC20-0134.   "
243183|NCT01031771|"     The purpose of this study is to correlate the alimentary consistencies and deglutition     disorders in children with cerebral palsy.   "
243079|NCT01038583|"     The ASPREE study will examine whether the potential benefits of low dose aspirin     (particularly preventing heart disease, stroke, certain cancers and dementia) outweigh the     risks (particularly bleeding) in people over age 65.      ASPREE will determine whether taking a daily low-dose aspirin will extend the length of a     disability-free life in healthy participants aged 65 years and above.   "
243015|NCT01037751|"     Objectives:      The objective of this study is to delineate and measure the symptom burden experienced by     patients with ovarian cancer.      The Primary Aim is to develop and validate an ovarian-cancer module of the M. D. Anderson     Symptom Inventory (MDASI-Ovarian Cancer) to measure the severity of multiple symptoms and the     impact of these symptoms on daily functioning in patients with ovarian cancers.      The Secondary Aims are:      To develop a detailed description of symptom severity and interference with daily activities     experienced by patients with ovarian cancer; To assess the impact of symptom severity on     standard functioning and quality of life (QOL) measures, including Eastern Cooperative     Oncology Group Performance Status (ECOG PS), Functional Assessment of Cancer Therapy-Ovary     (FACT-O), and a single-item QOL scale, in patients with ovarian cancer; To define the     qualitative symptom burden of patients with ovarian cancer receiving various treatments.   "
243016|NCT01037764|"     [Study Objectives]        -  To evaluate the efficacy of allogeneic hematopoietic cell transplantation (HCT) in          patients with acute lymphoblastic leukemia (ALL) in the first or second complete          remission (CR). The efficacy of the treatment will be measured in terms of the frequency          of relapse and duration of remission (the primary endpoints).        -  The secondary end points of the study include; engraftment, donor chimerism, secondary          graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery,          infections, transplantation-related mortality, leukemia free survival, and overall          survival.   "
243017|NCT01037777|"     The spinocerebellar ataxias (SCAs) are a clinically and genetically heterogeneous group of     autosomal dominantly inherited progressive ataxia disorders. It is estimated that there are     30,000 individuals in the European Community that directly descend from individuals affected     by a SCA disorder and thus carry a 50% risk of having inherited an SCA mutation. These at     risk individuals provide a unique research opportunity to prospectively study the     presymptomatic phase of SCA disorders and to identify the earliest and most sensitive     clinical signs and biological markers that herald the onset of the illness. This information     is of critical importance for the development of future therapeutic interventions aimed at     postponing the clinical onset of ataxia.      We therefore propose to perform a prospective observational study of individuals at risk for     the most common SCA disorders, SCA1, SCA2, SCA3 and SCA6 (RISCA). It is our aim to answer the     following questions: (1) What is the incidence of disease manifestation in mutation carriers?     (2) Which clinical signs precede the onset of manifest ataxia in SCA1, SCA2, SCA3 and SCA6?     (3) What are the prevalence and incidence of preceding signs? (4) Are the prevalence and     incidence of preceding signs affected by genotype, gender, age, estimated time until disease     manifestation and repeat length? (5) Does the presence of certain preceding signs predict the     manifestation of ataxia ? (6) Are there MRI alterations that precede the onset of ataxia? It     is planned to enroll 480 study participants and to follow them at regular intervals over six     years. At each visit, study participants are asked in a structured interview for a number of     predefined clinical signs that potentially precede the onset of ataxia. In addition, the     following self-assessment scales will be applied: Pittsburgh Sleep Quality Index (PSQI),     Diagnostic Criteria for Restless Legs Syndrome, Patient´s Health Questionnaire (PHQ-9). All     study participants will undergo a physical examination including the Scale for the Assessment     and Rating of Ataxia (SARA). Study participants will further perform the SCA Functional     Composite (SCA-FC) which is a comprehensive measure of functional capacity based on results     in quantitative tests related to gait (8m timed walk), speech (PATA rate) and hand function     (9 hole pegboard). In a subset of study participants, we will record eye movements and obtain     volumetric MRIs. The study will also be used to collect and store blood and urine samples for     proteomic and gene expression studies.      RISCA is conducted by the Ataxia Study Group (ASG). It relies on the network structure     created by the EUROSCA project.   "
243018|NCT01037790|"     RATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in     treating patients with refractory solid tumors.   "
243019|NCT01037803|"     Does sublingual SDF-imaging results correlate with other haemodynamic parameters measured     perioperatively and with postoperative morbidity/complications.   "
243020|NCT01037816|"     The objective of this study is assess the efficacy and safety of single and multiple     applications of the FS-67 patch in the treatment of ankle sprain in pediatric population     (ages 13-17).   "
243021|NCT01037829|"     The primary objective of this observational, comparative safety study is to evaluate the     safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off     spring, followed for up to 3 months of age as compared to pregnant women who have not     received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at     investigative sites within the Netherlands, Italy, and Argentina.   "
243022|NCT01037842|"     We performed a prospective, randomized, multicenter trial to assess the efficacy and safety     of combined treatment with mitiglinide and metformin for patients with type 2 diabetes who     show inadequate glycemic control with metformin monotherapy. Subjects with HbA1c >7.0% after     an 8-week metformin run-in phase were randomized to a 16-week trial phase with metformin plus     mitiglinide (Met+Mit) or metformin plus placebo (Met).   "
243023|NCT01037855|"     This is an observational study of safety and occurrence of influenza-like illness following     administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit     vaccine in subjects 6 months of age and older.   "
243024|NCT01037868|"     Background:      There is abundant evidence that rates of comorbidity between substance use and depression are     high (1, 2) and the risk of poor outcome is higher among individuals with the dual disorder     compared with those with a single disorder (3, 4, 5, 6). Previous research has shown that     about 50% of persons studied with severe mental illness and past substance abuse are likely     to have a recurrence of substance abuse within 1 year of discharge from treatment (7).      There is therefore a clear clinical challenge in treating patients with the dual disorder     which may calls for further research and the possible introduction of new and innovative     strategies including the use of mobile phone technology to provide increased support for     patients with the dual diagnosis.      There are established research evidence for using Short Message Service (SMS) text messages     to remind patients of scheduled medical appointments (8,9,10,12, 13), coordinate medical     staff,(14) deliver medical test results,(15,16) , promote smoking cessation ( 17), improve     self-monitoring among the youth with type 1 diabetes( 18), promote weight loss among obese     subjects (19 ) and monitor patient side effects following treatment(20).      Relevance of the research:      To date, after an extensive review of the literature using MEDLINE, Pub Med, ERIC, Web of     Science, Science Direct and PsycINFO, no studies was found on the use of SMS text messages as     an intervention to address abstinence amongst alcohol dependent subjects who are co-morbid     for a depressive disorder. Thus, the investigators seek to determine if text messaging is a     useful and effective strategy to help maintain abstinence, improve adherence with medication     and ultimately promote mental stability in depressed patients discharged from an in-patient     dual diagnosis programme. The investigators hypothesize that, daily supportive/reminder SMS     text messages to depressed patients discharged from an in-patient dual diagnosis programme     would increase alcohol abstinence rates , improve medication adherence rates and improve the     overall mental well being of patients compared with those receiving treatment as usual.   "
243025|NCT01037881|"     This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with     vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment     regimen in mild to moderate atopic dermatitis patients.   "
243026|NCT01037894|"     The purpose is to establish whether acupuncture in addition to conventional rehabilitation     programme can improve the functional outcome and quality of life of surgical patients with     haemorrhagic stroke, as compared to conventional rehabilitation programme alone.   "
243028|NCT01037920|"     The objective of the project is a test-of-concept of an intervention to reduce the effects of     the perception of discrimination on the care of patients with chronic illness. Perception of     discrimination manifests itself as stereotype threat. We hypothesize that stereotype threat     impairs communication between minority patients and their physicians because of increased     stress and diminished trust, resulting in interactions that are less successful at enhancing     patient self-efficacy, in turn resulting in lower rates of adherence with anti-hypertensive     medication.      The intervention is a self-affirmation exercise performed prior to a patient-physician visit.     A similar intervention has been shown to reduce the racial gap in academic performance in     middle school classrooms.      We will explore the mechanistic effects of the intervention by analysis of audiotapes of     patient-provider visits following the intervention. We will measure the effect of the     intervention on minority hypertensive patients' adherence with antihypertensive medication     and blood pressure.      We will enroll 200 African American and Latino patients with hypertension and randomize 100     patients to perform the exercise and 100 patients to perform a null control exercise before     the visit. We will assess change in patient's adherence with antihypertensive medications and     in blood pressure over the six months following the index visit. In order to better     understand the effects of the intervention we will measure subject's mood following the     exercise, and self-reported stress levels, trust in the physician, and medication     self-efficacy following the visit. We will also assess the quality of the patient-provider     interaction from detailed analysis of audiotapes and from patient questionnaires. Following a     subsequent patient-physician visit, we will conduct telephone interviews with patients to     assess for persistence of any effects of the intervention.   "
243029|NCT01037933|"     Primary aims: To compare changes in (a) symptoms related to cancer and chemotherapy, (b) a     marker of immune function (salivary immunoglobulin A), and (c) a hormonal marker of emotional     stress (salivary cortisol) between two groups of patients who view a humorous or non-humorous     DVD.      Secondary aim: To describe the perception of patients, caregivers, and nurses regarding the     overall intervention experience.   "
243030|NCT01037946|"     This project aims to support adults in HIV-affected families in order to improve their     well-being. UCLA's Center for Community Health (CCH), in collaboration with the Thai Ministry     of Public Health, Bureau of Epidemiology, will implement the Family-to-Family (F2F)     intervention in order to improve the social, behavioral and mental health outcomes for     families affected by HIV.      In Phase 1, the investigators pilot tested the current intervention contents and activities     by collecting qualitative data from HIV+ families in the four district hospitals in Chiang     Rai and Nakohn Ratchasima provinces selected for the proposed study. The findings from Phase     was used to develop intervention content, as well as the format and style of the intervention     for Phase 2. In addition, the findings from Phase 1 was used to finalize the assessment     measures the investigators will use in Phase 2.      In Phase 2, 410 families with HIV+ parents from 4 district hospitals in Chiang Rai & Nakhon     Ratchasima Provinces will be recruited to an intervention to benefit their school-aged     children aged 6-17 years. At their clinical care site,the investigators randomly assigned     families to either: 1) F2F, a psychoeducational intervention for HIV+ parents and family     caregivers; or 2) a Standard Care condition. The impact of the F2F intervention will be     monitored over 24 months.   "
243031|NCT01037959|"     Patients with advanced cirrhosis have abnormal translocation of Gram-negative bacteria across     the intestinal barrier and subsequent systemic inflammatory response. We hypothesized that     this translocation may worsen the underlying liver disease. Thus, the aim of this trial was     to assess the effects of the oral administration of norfloxacin (an antibiotic that     suppresses intestinal Gram-negative bacteria) on the development of complications of     cirrhosis.   "
243032|NCT01037972|"     40 patients with osteoarthritis of the knee will be randomly assigned to conventional     physiotherapy on the one and whole body vibration exercises on the other hand. The duration     of the training will be 6 weeks, three times a week.      The outcome will be measured by WOMAC and SF-12 scores relating to pain and quality of life.     The second outcome criteria will be a motion analysis and balance testing before and after     the training.      The follow-up is 26 weeks.   "
243033|NCT01037985|"     The study will investigate the ability of EXC 001 to improve the appearance of scars in     subjects undergoing an elective abdominoplasty. The study will also evaluate the safety and     tolerability of EXC 001.   "
243034|NCT01037998|"     Iressa [epidermal growth factor tyrosine kinase inhibitor (EGFR-TKI)] has been reported to     activity against Non-small-cell Lung Cancer (NSCLC) failed previous chemotherapy. UFUR was     found to have anti-angiogenesis effect when long term treatment was given. Combination of     EGFR-TKI and anti-angiogenesis agents is a novel treatment.   "
243035|NCT01038011|"     Randomized, controlled, double-blind, multicenter phase II study comparing risedronate 35mg     (ActonelR 35mg weekly tablet) versus placebo in patients with active ankylosing spondylitis     (AS) treated with standard first and second-line therapies.      Primary efficacy endpoint: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The     time schedule for performing the BASDAI was at screening, upon inclusion (T0), then after 3,     6 and 12 months or at the time of premature withdrawal in case of drop-out.      secondary endpoints:        -  Clinical endpoints: The secondary efficacy measures were the following: Bath Ankylosing          Spondylitis Functional Index (BASFI) , Bath Ankylosing Spondylitis Metrology Index          (BASMI), ASAS (Assessments in Ankylosing Spondylitis) Working Group core set of domains,          Spinal pain VAS, ESR, CRP and the percentage of patients achieving 20% or greater          decrease in each of these parameters. These parameters were determined at T0, T3, T6,          T12 or at the time of premature withdrawal in case of drop-out. The spinal pain assessed          by VAS was also done at screening.        -  DEXA: Dual Energy X-Ray-Absorptiometry (DEXA) measurements were performed in all          patients upon inclusion (T0) and at the end of the study (T12).        -  Biochemical markers: selected biochemical markers of bone metabolism were measured at          T0, T3, T6 and T12 or at the time of premature withdrawal in case of drop-out using          commercially available kits. Bone formation was assessed by serum bone-specific alkaline          phosphatase (BAP) and osteocalcin (OC) levels using commercially available kits. Bone          resorption was assessed in serum by the C-terminal telopeptide of type I collagen          degradation (Crosslaps R) and urinary N-terminal telopeptide of type I collagen          degradation (Osteomark R).        -  Trial with medicinal product   "
243036|NCT01038024|"     The purpose of this study is to evaluate the basis for the reported good effects of     antioxidant supplementation. A blood test using Mass Spectrometry will measure DNA damage     which is expected to decrease with antioxidant administration and therefore decrease the risk     of cancer.   "
243037|NCT01038037|"     The purpose of this study is to determine whether the addition of panitumumab to standard     chemotherapy in first-line treatment of advanced Non Small Cell Lung Cancer improves the     treatment outcome. Patients are selected based on triple mutational status.   "
243038|NCT01038050|"     Type 2 diabetes is associated with a markedly increased risk for atherosclerotic coronary     arteries and cerebrovascular diseases. The major cause of death in diabetic patients is     cardiovascular disease in the world including Taiwan. Atherosclerosis is a progressive     disease characterized by the response of the vessel wall to chronic, multifactorial injury,     which leads ultimately to the formation of atheromatous or fibrous plaques. Endothelial     dysfunction is thought to be the initial stage of atherosclerosis. Endothelial dysfunction     leads to impaired control of vascular tone, a decreased in the release of anti-inflammatory     factors and reduced availability of nitric oxide. Endothelial dysfunction portends diabetic     vasculopathy. The loss of intact endothelial integrity and function sets in motion a cascade     of serial events that lead to atherosclerosis and cardiovascular complications.      The standard extracts of G. biloba leaves [G. biloba extract (GBE)] are now demonstrated the     cardiovascular, cerebrovascular and neuroprotective effects. The mixture of biologically     active ingredients in GBE accounts for the pleiotropic effects, including antioxidant     effects, inhibition of platelet aggregation and thromboxane B2 production, vasodilation and     modulation of cholesterol metabolism. Clinically, GBE was widely used in management of     vertigo、dementia and improving peripheral circulation. In our previous study, ginkgo biloba     extract inhibits tumor necrosis factor-alpha-induced reactive oxygen species generation,     transcription factor activation, and cell adhesion molecule expression in human aortic     endothelial cells. In addition, the similar benefit of prevention atherosclerosis was also     found in animal study.      Heme oxygenase-1 (HO-1) is a factor associated with higher risk of developing some vascular     disease and also a rate-limiting enzyme in heme degradation, leading to the generation of     free iron, biliverdin, and carbon monoxide (CO). CO exerts potent antiproliferative and     anti-inflammatory effects in the vascular walls, thereby influencing neointimal formation     after vascular injury. In addition, biliverdin is subsequently metabolized to bilirubin by     the enzyme biliverdin reductase. Therefore, induction of HO-1 elicits potent     anti-inflammatory, antiproliferative, antithrombotic, and antioxidant effects in the     circulation via the generation of CO and bilirubin. Interestingly, recent study found that a     long guanidine thymidine dinucleotide repeat [(GT) n≧ 30] in the HO-1 promotor, which is     linked to impaired inducibility, is associated with a higher frequency of vascular access     failure.      In the present study, we will investigate the effect of GBE on recovering endothelial     dysfunction and inflammation in diabetic patients with stable coronary artery disease. In     particularly, we intend to determine whether the GBE modulates the HO-1 expression and     investigate whose genotyping including some candidate gene about atherosclerosis and     hypertension will have most therapeutic effect of GBE.   "
243039|NCT01038063|"     A community-based, open-label, cluster-randomised longitudinal study in which children are     randomized according to village health worker catchment areas comparing the safety and     effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period     in children 4-48 months to that of repeated treatment with dihydroartemisinin-piperaquine     (DHA-PPQ).   "
243040|NCT01038076|"     This study will examine whether a computerized, self-administered assessment of patient     medication adherence and health behaviors, plus support for adherence, improves the ability     of clinicians to identify adherence problems and leads to better adherence.   "
243041|NCT01038089|"     Observational studies have shown that consumption of grapes and grape products such as red     wine is associated with reduced cardiovascular risk. The mechanisms accounting for this     benefit remain incompletely understood. Resveratrol is a component of grapes and red wine     that has favorable effects on endothelial function in diabetic and obese animals. Resveratrol     is available to people over-the-counter in health food stores and the internet as a dietary     supplement.      The endothelium plays a central role in the control of blood vessel function. When healthy,     the endothelium prevents vasospasm, blood clot formation, and the development of     atherosclerosis. Endothelial function is abnormal in patients with diabetes mellitus and this     abnormality contributes to the development of cardiovascular disease.      The present pilot study is designed to test the hypothesis that resveratrol (90 mg/day and     270 mg/day for one week each) will have favorable effects on endothelial function in patients     with diabetes mellitus.   "
243042|NCT01038102|"     The purpose of this study is to investigate whether substituting saturated fats with     polyunsaturated fats reduces fatty liver and improves insulin action and other metabolic     variables in abdominally obese subjects   "
243043|NCT01038115|"     The purpose of this study is to perform a prospective, randomised study investigating the     safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation,     or both together in the treatment of paroxysmal AF.      The hypotheses for this study are (1) that cryothermal energy is as effective and safe as     using radiofrequency energy in the treatment of paroxysmal AF and is associated with a better     long term outcome, and (2) that use of both cryothermy and RF in combination is as effective     and safe as using either radiofrequency energy or cryothermy alone and is associated with a     better long term outcome.   "
243044|NCT01038128|"     The primary objective of this 13-week clinical trial is to test the hypothesis that treatment     with Memantine will significantly improve the symptoms of those suffering from either bulimia     nervosa, purging type or suffering from body dysmorphic disorder.   "
243045|NCT01038141|"     The purpose of this study is to compare a new mini invasive surgical procedure (Recto Anal     Repair) to the traditional Milligan-Morgan procedure in patients suffering from severe piles.   "
243046|NCT01038154|"     The survival of esophageal cancer and stomach cancer (EGC) at 5 years is less than 30%.     Pravastatin is a potent inhibitor of HMG-CoA reductase inhibitor that has shown increased     survival in patients with advanced hepatocellular carcinoma. The objective is to evaluate the     efficacy of treatment (increase in survival and recurrence-free period of the disease) with     pravastatin in patients with advanced EGC. The investigators have designed a randomized,     controlled and open. Advanced stage was considered for patients with T4 or N1 or M1 according     to the TNM classification. It has been estimated sample size per treatment arm of 73 patients     (146 patients in total). Randomization was done on a stratified by location (CE or CG). All     patients receive hatitual treatment (surgery and / or chemotherapy and / or radiotherapy and     / or palliative) for each of their clinical conditions. The experimental group will receive     one tablet of 40 mg of pravastatin orally every 24 hours (breakfast) for 2 years. There will     be a monthly monitoring of these patients for at least 2 years which includes an analytics.     Every 2 months there will be an abdominal-pelvic CT scan to assess progression and treatment     response.   "
243047|NCT01038167|"     The purpose of this study is to evaluate the effect that telaprevir has on the     pharmacokinetics of cyclosporine and tacrolimus. Pharmacokinetics means how the drug is     absorbed into the bloodstream, distributed in the body and eliminated from the body.   "
243048|NCT01038180|"     This study examines possible risk factors with regard to complications following pacemaker     implantation.   "
243049|NCT01038193|"     This is a longitudinal, multi-center, prospective study of aneurysmal subarachnoid     haemorrhage patients in neurosurgical units in Hong Kong.   "
243050|NCT01038206|"     The focus of this study will be to test the Familias Unidas Intervention program among     Hispanic 8th graders in the Miami-Dade County Public School System. This study will     contribute to the advancement of knowledge in both the scientific community and the Hispanic     population in Miami-Dade County. It will shed light on whether and to what extent Familias     Unidas is effective in preventing drug use and unsafe sexual behavior in Hispanic     adolescents. To the scientific community, the investigators will disseminate our findings via     peer-reviewed publications and presentations at scientific meetings.      The design for the proposed study is a randomized controlled trial. This design is considered     the gold standard design when evaluating the efficacy of two (or more) treatment     conditions. Participants for this study will be 744 Hispanic 8th grade adolescents and their     parents recruited from 24 randomly selected middle schools in Miami Dade County that meet the     school inclusion/exclusion criteria. A total of 12 schools (for a total of 372 Hispanic     adolescents and their parents) will be randomized to Familias Unidas and a total of 12     schools (for a total of 372 Hispanic adolescents and their parents) will be randomized to the     Community Practice.   "
243051|NCT01038219|"     Background: Fever is a widespread symptom in many diseases. Therefore, its value and     diagnostic importance are well known. Fever in children is one of the common reasons for a     visit to the pediatrician. Also, taking temperature is a very simple action and accessible to     the general public.      Temperature is measured in various parts of the body by using medical equipment. The type of     method and thermometer varies according to the patient's age but often temperature is     estimated by touch. Temperature measurement serves as a means for monitoring the patient's     condition. For that reason, supervision of the body temperature is an important factor in the     process of taking medical decisions.      Study rationale: the parent is often asked if the child's temperature has been taken. The     most frequent answer is: I didn't measure, but I felt that he has a temperature. The few     studies carried out on this subject showed that many parents used touch to evaluate the     child's body temperature, especially in infants.      Some studies checked the reliability of parents to estimate the child's body temperature by     touch only. To the best of our knowledge, the reliability of medical staff (nurses) to     estimate the child's body temperature by touch has never been studied.      The aim of the current study is to investigate whether parents and nurses correctly estimate     the child's body temperature by touch, as compared to thermometer measurement during the     pediatric unit's routine work.   "
246918|NCT01084330|"     A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs     known to be effective against gastric cancer in second line therapy for patients who have     failed one line of chemotherapy.   "
243052|NCT01038232|"     Background:      - People who are in treatment for substance abuse often feel distress during the withdrawal     period and afterward. Some individuals feel distress more acutely than others, and this     distress has been linked to poor treatment outcomes and increased risk of relapse in smokers,     alcoholics, and cocaine- and heroin-dependent individuals. More research is needed on the     effects of distress on the brain, particularly in individuals who are seeking treatment for     substance abuse. Researchers are interested in using functional magnetic resonance imaging     (fMRI) scanning to study distress tolerance in both substance users seeking treatment and     healthy non-drug-using volunteers.      Objectives:      - To use functional magnetic resonance imaging to study the effectiveness of a distress     tolerance assessment.      Eligibility:      - Individuals between 18 and 50 years of age who are either cocaine dependent or healthy     non-drug-using volunteers.      Design:        -  This study involves an initial screening visit and a scanning visit, with four followup          visits.        -  Participants will be screened with a medical history and physical examination, as well          as blood samples and questionnaires about mood and past and current drug use.        -  Participants will have a structural MRI scan of the brain to provide a baseline reading          for comparison. Participants will then have an fMRI scanning session, which will include          both the distress tolerance assessment and relevant control tasks. Heart rate, blood          pressure, and other physical reactions will be monitored throughout the scan.          Participants will also provide blood and saliva samples to measure stress hormone          levels.        -  Participants will be eligible to have followup assessments with fMRI scanning 1, 3, 6,          and 12 months after the scanning visit.   "
243053|NCT01038245|"     Background:      - Central nicotinic acetylcholine receptors (nAChRs) are primary targets for the action of     nicotine. In addition to being involved in tobacco dependence, they are also involved in a     variety of brain disorders, including Alzheimer's and Parkinson's diseases. Researchers are     interested in developing better ways to study the action of nAChRs to improve treatments for     smoking cessation and other problems affected by these receptors. These new study methods may     involve different approaches to positron emission tomography (PET) scanning, which can show     brain activity related to nAChRs.      Objectives:      - To evaluate appropriate and useful doses of radiotracers used in PET scanning of nAChRs in     the brains of nonsmokers/former smokers, light smokers, and heavy smokers.      Eligibility:      - Individuals between 18 and 50 years of age who fall into one of the following groups: (1)     nonsmokers or former smokers who have not smoked for the past 2 years, (2) light/situational     smokers, or (3) heavy smokers (at least 15 cigarettes/day for the past 2 years).      Design:        -  Each participant will undergo up to three PET studies, given approximately1 month apart.          Each study will take approximately 8 hours to complete.        -  Participants will provide urine and breath samples before the study and at the start of          the study, which will be tested for chemicals that may interfere with the study.        -  Depending on the study, some of the smoking participants may receive a nicotine patch to          wear during the PET scan.        -  On the day of the study, participants will receive a dose of a radiotracer (a drug used          in PET scanning) given either as a single injection or as an injection followed by a          continuous infusion, and will have a series of PET scans over the next 7 hours and          provide blood samples during that time.        -  Participants will return for a follow-up visit 1 month after the end of the study.   "
243054|NCT01038258|"     A PET scan drop less than 20% in SUVs or below a certain absolute SUV value after the first     course of neoadjuvant chemotherapy can predict pathological response, and could in the future     lead to an early surgical intervention.   "
243055|NCT01038271|"     The main purpose of this study is to compare two types of treatment-standard palliative care     (which usually is given towards the end of life) and integrated palliative care (which is     given soon after diagnosis) to see which is better for improving quality of life of     participants with advanced non-small cell lung cancer. Palliative care is care that tries to     lessen the symptoms of a disease. Although many people with advanced lung cancer receive     palliative care or hospice toward the end of their disease, the entire course of their     disease is often complicated by physical and emotional difficulties. Palliative care may be     useful when it is started soon after diagnosis.   "
243056|NCT01038284|"     Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which     treatment has evolved in the last few years, improving quality of life. However, adherence to     treatment has not been assessed in such patients. The investigators developed a collaborative     care model involving clinical pharmacists in PAH. The objective of this work is to evaluate     the impact of such model of care on medication errors and adverse events, quality of life and     clinical criteria.      This randomized multicentre controlled study will include approximately 100 PAH patients     (NYHA II to IV). After inclusion, patients will receive either collaborative care including     consultations with specialized pharmacist and nurse, or classic follow-up. Each patient will     be followed during 18 months from the date of inclusion.      The investigators hope to show the positive impact of a collaborative care model in PAH. More     specifically, the investigators aim to show the interest of long-term patient education to     improve patient safety related to drugs, but also their quality of life, and have preliminary     data about usual clinical criteria.   "
243057|NCT01038297|"     The study will investigate the ability of different dose levels and regimens of EXC 001 to     improve the appearance of scars in subjects undergoing an elective abdominoplasty. The study     will also evaluate the safety and tolerability of EXC 001.   "
243058|NCT01038310|"     The investigators aim to study whether the nuclear medicine method FP-CIT-SPECT (more details     see below) allows to predict the further clinical course of Parkinson´s disease. Especially     the investigators are interested in the motor and cognitive functions of the parkinsonian     patients.   "
243059|NCT01038323|"     Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and     societal costs in terms of quality of life, social and work functioning, health care use, and     lost productivity. Although single therapy approaches such as medication, graduated exercise,     and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the     majority of FMS continue to report significant levels of pain and pain-related disability.     Testing the efficacy of using combination therapies such and CBT with medication has     considerable potential to maximize treatment response. Also, exploring the biological and     psychological mechanisms underlying combination treatment may pave the way for developing new     treatments for FMS sufferers.      We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate     medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment     arm in a study that has both time and budgetary constraints, 3) the complexity in     understanding the mechanism of actions of 3 different modes of intervention in one clinical     trial, and 4) the desire to explore mechanisms in this program of research, in particular the     potential effects of a biological intervention (drug) on what is traditionally considered a     psychological outcome (pain-related attributions and cognition) and the potential effects of     a psychological intervention (CBT) on what is traditionally considered a physiological     outcome (pain sensitivity).   "
243077|NCT01038557|"     The purpose of this study is to look at red blood cell(RBC)transfusions in trauma patients     and evaluate for any differences between the age of the RBCs and how they were stored. The     investigators will specifically look for the following differences between study groups:        1. the transfused red blood cells' ability to delivery oxygen to the tissues        2. changes in the how the RBCs' look or act under a microscope and        3. how the subject's internal organs are working and if they develop any infections   "
243060|NCT01038336|"     Hearing loss is the most prevalent service-connected disability in the VA. It causes     communication difficulties, which contribute to isolation, frustration and depression. A     major cause of hearing loss is from exposure to high levels of sound, and is referred to as     Noise Induced Hearing Loss (NIHL). Veterans have inevitably been exposed to high levels of     sound during military service, and even though they may not yet have NIHL, their ears have     been damaged. Continued noise exposure in civilian life will result in NIHL. However, it can     easily be prevented by avoiding noise or using hearing protection. Most people are unaware     that noise damages hearing, and even when they are, they do not use hearing protection. In     this study we will use a randomized controlled trial to evaluate the short- and long-term     effectiveness of two forms of education about NIHL that we have developed for Veterans. One     is a computerized program; the other is a Hearing Conservation Brochure   "
243061|NCT01038349|"     The goal of this study is to enable the study sponsor to assess the impact of a marketed or     validated blood test has on physicians' clinical treatment decision making when treating RA     patients who have been taking methotrexate.      Ultimately, the blood test will allow treating physicians to modify current methotrexate     therapy in partially responding Rheumatoid Arthritis (RA) patients' therapy, on an     individualized basis, as a means of improving clinical outcomes.      The study requires a blood sample from RA patients who have been on methotrexate therapy for     a minimum of 3 months and are having an inadequate response to therapy. Physicians will then     be provided with the results of the test indicating the methotrexate polyglutamate (active     metabolites of methotrexate) levels in the patient's red blood cells as a means to help     determine whether a patient's exposure to methotrexate has been optimized.   "
243062|NCT01038362|"     The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm     and thrombosis by production of a variety of regulatory substances, including nitric oxide.     In patients with atherosclerosis, these functions of the endothelium are impaired and these     abnormalities may contribute to the development of heart attack and stroke.      Observational studies have shown that frequent nut consumption decreases the risk of     cardiovascular disease (CVD), but the mechanisms of benefit have not been fully defined.     Recent studies suggest that specific fatty acids and flavonoids in nuts may have favorable     effects on cardiovascular disease. In addition, there is growing evidence that these     compounds may improve the function of the endothelium.      The present study is designed to test the hypothesis that an almond-enriched diet will     improve the function of the endothelium in patients with coronary artery disease. Subjects     will be enrolled into a randomized, placebo-controlled, crossover study that will compare a     National Cholesterol Education Program Step 1 diet without nuts to a Step 1 diet that has the     same number of total calories but includes 3 ounces of almonds daily. Participants will     consume each diet for six weeks with a four-week rest period between diets. The order of     diets will be randomized (almonds or no almonds). Dietary assessments via food recall     questionnaires will be employed at the study entry, end of the four week washout period, and     end of the second intervention. If subjects are drifting from the recommendations of the STEP     1 diet, counseling will be given to urge compliance. The primary endpoint will be     endothelium-dependent flow- mediated dilation assessed by ultrasound. Secondary study     outcomes will include lipid profiles, markers of inflammation and oxidative stress.     Enrollment will continue until 40 subjects with complete data are available.      Patients will be enrolled at Boston Medical Center and the Jean Mayer US Department of     Agriculture Human Nutrition Research Center at Tufts Medical Center. Dietary interventions     will be performed at Tufts Medical Center or by telephone. Ultrasound studies and blood     collection will be performed in the principal investigator's research unit at Boston Medical     Center.   "
243063|NCT01038375|"     The purpose of this study is to determine the effectiveness of interventions to improve     adherence to medication and healthier lifestyle choices on blood pressure over a 6 month     period in a group of people at high risk for recurrent stroke events. The participants have     already had a stroke or TIA, and have uncontrolled blood pressure, as well as problems with     memory and problem-solving, or miss taking medications, or who do not believe in the     effectiveness of their medications. Interventions focus on motivational interviewing,     adherence counseling with memory cuing, and self-monitoring of blood pressure.   "
243064|NCT01038388|"     The purpose of the study is to evaluate the clinical effectiveness and side effects of the     vorinostat, bortezomib, lenalidomide, and dexamethasone investigational combination.   "
243065|NCT01038401|"     HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens.     Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing     low-level virus replication. This project aims to characterize the residual replication of     HIV-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid     tissue.   "
243066|NCT01038414|"     The purpose of this study is to determine if extending the behavioral smoking-cessation     treatment period to one year will significantly improve cessation outcomes among those     planning a quit attempt.   "
243067|NCT01038427|"     This study will compare the safety and efficacy of a generic mometasone nasal spray to the     reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the     test and the reference formulations will be tested for superiority against a placebo nasal     spray.   "
243068|NCT01038440|"     The purpose of this study is to assess the relationships between dose and time of consumption     of stearidonic acid (SDA) and eicosapentaenoic acid (EPA) on EPA enrichment of red blood cell     (RBC) membranes in men and women.   "
243069|NCT01038453|"     The purpose of this study is to determine whether a daily supplement of vitamin D, taking     before and during pregnancy, effects child birth weight, pre- and postpartum complication and     bone mineral density during lactation.   "
243078|NCT01038570|"     The role of oxytocin (OT) is already known in the regulation of satiety but some clinical     studies demonstrated that OT participates also in the regulation of social behavior by its     implication on a better comprehension of emotion which plays a role on theory of mind and     empathy. By the way, these 2 behaviors are deviants for patients with Prader-Willi Syndrome     (PWS). Actually, no study was led on the effect of OT on PWS patients but Swaab and al in     1995 showed a significant reduction in number and in volume of neurons expressing OT in the     paraventricular nucleus of PWS patients. Recent data were obtained studying OT in patients     with autism which showed a link between the deregulation of OT and the autistic pathology.     Clinical and imaging studies obtained with PWS and autistic populations make us believe that     some mechanisms are common between these two pathologies.      The objectives of this project are:        1. to look for an influence on the understanding of the social codes of the PWS patients,        2. to look for an influence on the behavior of stress and anxiety and on the regulation of          eating habits when patients receive a nasal pulverizing of OT.   "
243184|NCT01031784|"     The HEPAR study is aimed at determining the safety of radioactive holmium containing     microspheres for the treatment of tumors in the liver. These microspheres will be     administered by infusion in the liver artery using a arterial catheter in the femoral artery.   "
243070|NCT01038466|"     The aim of the CHAT study (An open-label, randomized Phase II study of Herceptin     (trastuzumab), Taxotere® (docetaxel) and Xeloda (capecitabine) in combination, versus     Herceptin (trastuzumab) plus Taxotere® (docetaxel), in patients with advanced and/or     metastatic breast cancers that overexpress HER2) was to test the combination of Trastuzumab     and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally     advanced or metastatic breast cancer.      Overall Response Rate was the primary endpoint of the CHAT study. This study failed to meet     its primary objective of showing a difference between the treatment groups, with equivalent     high response rates for the Trastuzumab plus Docetaxel and Trastuzumab, Docetaxel plus     capecitabine arms.      Secondary endpoints in the CHAT study were Progression-Free-Survival, Time-to-Progression,     Overall Survival, duration of response and safety profile. Whilst analysis of the existing     data is consistent with improvement with the triplet therapy, interpretation is compromised     by the relatively short median follow-up of 24 months. In hindsight the statistical design     was flawed by selection of a sub optimal primary endpoint and consequently data was collected     and analysed early in relation to time-dependent endpoints. Beyond CHAT will permit capture     of mature data for time-related endpoints. Time-to-Progression and Overall Survival are the     co-primary endpoints for the Beyond CHAT protocol. The impact of treatment following the     first progression, on survival, will be explored.      Time-to-Progression will be defined from the time interval between the date of randomisation     and the occurrence of progressive disease under therapy according to RECIST criteria.      Overall Survival will be defined as the time from date of randomisation to date of death   "
243071|NCT01038479|"     The purpose of this study is to determine if the Childsmile programme (www.child−smile.org)     with the additional maternal use of xylitol is more effective at reducing dental decay in     children than a Childsmile program alone.      The children will be compared in the two groups at age two, to determine how the     interventions affected the early colonization of mutans streptococci, an important risk     factor of tooth decay.      At three and at five years the investigators will also examine the amount of tooth decay in     these children.      Using MIDAS (Scotland's national health service dental data) records, the investigators will     follow the oral health of the children until the age of 5 years.      Main hypothesis:      The maternal consumption of xylitol reduces early childhood caries   "
243072|NCT01038492|"     Smoking cessation is often difficult for smokers to achieve for a variety of reasons     including: difficulty with nicotine withdrawal, failure to perceive the benefits of smoking     cessation, and failure to perceive the risks associated with smoking. We argue that the most     effective biomarkers to affect perceptions of harm, especially for lung cancer, are those     that signal progression towards disease development Proposed is a pilot study of educating     smokers about the role of genetics and lung cancer in Durham VA out-patient clinics. The goal     of this pilot study is to assess the interest in study participation from the VA smoking     population, as well as to determine the fraction of subjects who will complete the study to     power a future larger trial. Interested patients will receive a 15 minute educational     presentation on the function of p16 and its role in development of lung cancer. They will     then be assessed for airway obstruction by hand-held spirometry followed by review of a     questionnaire assessing their understanding of the presented information, their concern for     developing lung cancer, and their desire to quit smoking. All patients will be offered     smoking cessation assistance at this point. Enrolled patients will then be given 3 sputum     cups to take home and return with morning sputum samples by mail. Samples will be assessed     for evidence of p16 methylation and patients will be informed of the results. Follow-up phone     interviews will be performed at 2 to 4 weeks after patients have received their results by     mail to assess their understanding of the results, and their desire to stop smoking. A final     phone interview will occur approximately 3 months after the sputum testing to assess attempts     to stop smoking as well as the patients continued understanding of their test results. For     purposes of this pilot, we are interested primarily in the descriptive statistics (e.g.,     frequencies) associated with the outcome of each objective (e.g., how many expressed     interest, how many returned the sputum samples).   "
243073|NCT01038505|"     The investigators center has also analyzed data over the last 7 years from deceased donor     (DD) and living donor (LD) kidney transplant recipients who were randomized into 3     immunosuppressive arms between 2000 and 2001. Thus the goal of the investigators study is to     reduce the toxic effects of traditional immunosuppressive regimens involving high-dose     calcineurin inhibitor agents by comparing low-dose TAC-MYF with low-dose TAC and de novo SRL     regimens. In order to minimize exposure to TAC, the investigators center has previously shown     favorable outcomes using combination Thymoglobulin and Zenapax (Daclizumab) for     anti-lymphocyte induction in the investigator population of patients.   "
243074|NCT01038518|"     The overall aim of the Health2010-14 is to monitor the prevalence and trends of common     chronic diseases (osteoporosis, diabetes, cardiovascular disease, asthma, allergy, and     eczema) that are often un-diagnosed in the general population as well as biomarkers of     micronutrient status. Specific aims include identification of novel lifestyle and genetic     risk factors for the above diseases by investigating gene-lifestyle interactions.   "
243075|NCT01038531|"     Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) represent a     spectrum of clinical syndromes of rapid respiratory system deterioration that are associated     with both pulmonary and systemic illness. These syndromes are associated with 30-40%     mortality with our current standard of care and are responsible for approximately 75,000     deaths in the US yearly. Current evidence-based care of ALI consists of a strategy of     mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit     further stretch-induced lung injury exacerbated by the ventilator. However, this strategy has     been shown to be associated with increased lung injury in a subset of patients and still is     associated with about a 30% mortality rate. Airway pressure release ventilation (APRV) is a     different, non-experimental strategy of mechanical ventilation currently in routine clinical     use. APRV is a pressure-cycled ventilator mode that allows a patient a greater degree of     autonomy in controlling his or her breathing pattern than ARDSNet ventilation. Use of APRV     has been associated with better oxygenation, less sedative usage, and less     ventilator-associated pneumonia in small studies compared with other ventilator modes.     However, debate exists over whether APRV might result in decreased or increased     ventilator-associated lung injury when compared with ARDSNet ventilation. We intend to     implement a randomized, cross over study looking at biomarkers of lung injury in patients     with acute lung injury during ventilation with APRV and using the ARDSNet protocol. Our     hypothesis is that airway pressure release ventilation is associated with lower levels of     lung injury biomarkers than ARDSNet ventilation.   "
243076|NCT01038544|"     The purpose of this study is determine if performing endobronchial ultrasound (EBUS) in     addition to standard endoscopic ultrasound (EUS) can increase the precision and accuracy of     staging esophageal cancer in comparison to EUS alone. The expectation is that EBUS can be     used to biopsy lymph nodes that: (1) because of their position in the mediastinum would be     inaccessible to EUS, or (2) would be inaccessible due to their position behind the esophageal     tumor.   "
243080|NCT01038596|"     Osteoarthritis (OA) is one of the most frequent musculoskeletal disorders and represents the     main indication for total joint arthroplasty. Multipotent mesenchymal stromal cells (MSCs)     can be easily isolated and culture expanded from bone marrow aspirates and provide an     excellent source of progenitor cells for cell-based regeneration strategies due to their ex     vivo differentiation and proliferation capacity. Although there are hints that MSCs derived     from OA patients may exhibit altered function the role of MSCs with respect to disease     development and progression of OA is not clearly understood to date. To assess whether     advanced-stage OA affects MSCs' suitability for musculoskeletal regenerative therapy, in the     present study, we compare proliferation and differentiation potential of MSCs from     osteoarthritic versus healthy donors.   "
243081|NCT01038609|"     The primary purpose of this study was to evaluate analgesic efficacy and safety of     hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain     following primary unilateral first metatarsal bunionectomy.   "
243082|NCT01038622|"     The main objective of this proof-of-concept study is to demonstrate that the only     administration of L-arginine, based on a suspected deficit monitored by nasal nitric oxide     measurement, can improve immune functions in critically ill patients at high risk of     nosocomial infection.   "
243083|NCT01038635|"     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of     lenalidomide that can be given in combination with azacitidine to patients with MDS or AML.      The goal of Phase 2 of this study is to learn if the combination dose of azacitidine and     lenalidomide found in Phase 1 can help to control MDS and/or AML.      The safety of this drug combination will be studied in both Phases.   "
243084|NCT01038648|"     The hypothesis is, in subjects with persistent impaired glucose tolerance(IGT) , sitagliptin     will decrease the conversion rate to diabetes as compared to a placebo in three years.   "
243085|NCT01038661|"     The Primary Objective is to evaluate the progression-free survival (PFS).      The secondary objectives are:        -  To compare the disease control rates of different doses of Docetaxel+Cisplatin as          first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST)          criteria;        -  To evaluate the overall response rate (ORR);        -  To evaluate the time to disease progression (TTP);        -  To evaluate the overall survival (OS);        -  To evaluate the toxicity.   "
243086|NCT01038674|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.   "
243087|NCT01038687|"     This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose     response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on     gastric, intestinal and colonic transit in patients with functional constipation.   "
243088|NCT01038700|"     This part of the project aims to describe changes in markers of vascular competence     (Endothelial Microparticles Platelet (EMP), Circulating endothelial cells (CEC) and     Circulating endothelial progenitors (EPC)) at different ages of lifespan both in     physiological state and in response to hypoxia-induced vascular stress.   "
243089|NCT01038713|"     This is a single center, randomized, unblinded study to compare the rate of occlusion of     plastic, uncovered metal, or fully covered metal biliary stents in patient's with surgically     resectable disease or those undergoing neoadjuvant chemoradiotherapy. We will also compare     occlusion rates between uncovered metal and fully covered metal biliary stents in those     patients determined to have surgically unresectable disease.   "
243090|NCT01038726|"     The purpose of this study is to gain a better understanding of the effects of exercise and     cognitive training on improving brain function in healthy older adults who may be at risk for     developing Alzheimer's Disease.   "
243091|NCT01038739|"     The purpose of the study is to determine which dose of mesalazine granules compared to     placebo is more effective in the prevention of recurrence of disease.   "
243092|NCT01038752|"     The purpose of this study is to evaluate the benefit of adding suramin at a non-cytotoxic     dose to carboplatin and docetaxel regimen in the treatment of chemo-naïve patients with     non-small cell lung cancer.   "
243093|NCT01038765|"     The purpose of this study is to investigate the effectiveness and possible mediating factors     of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.   "
243094|NCT01038778|"     This phase I/II trial studies the side effects and best dose of entinostat when given     together with aldesleukin and to see how well this works in treating patients with kidney     cancer that has spread to other places in the body. Entinostat may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Aldesleukin may stimulate the     white blood cells to kill kidney cancer cells. Giving entinostat together with aldesleukin     may be a better treatment for metastatic kidney cancer.   "
243095|NCT01038791|"     At present, little data is available in the medical literature regarding the affects of     humidification on NIMV efficacy, sleep quality and upper airway symptoms in patients     undergoing nocturnal NIMV.      The aim of the present pilot study is to assess the impact of two humidification systems on     sleep quality, NIMV efficacy, patient-ventilator interaction, prevalence of NIMV side     effects, compliance to treatment, in a group of stable patients already enrolled in a     long-term nocturnal mechanical ventilation program for chronic hypercapnic respiratory     failure or sleep hypoventilation.   "
243096|NCT01038804|"     The purpose of this study is to evaluate survival, response rate, safety and tolerability of     YM155 given in combination with docetaxel as first-line treatment in subjects with human     epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.   "
243097|NCT01038817|"     This study questions the interest of fluoride varnish dental application in preventing tooth     decay in a population of institutionalised elderly people.   "
243098|NCT01038830|"     The aim of this study is to evaluate the change of QuantiFERON-TB gold in tube assay (QFT)     during the treatment of active tuberculosis.   "
243103|NCT01030718|"     To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or     intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+)     acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will     continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)   "
243104|NCT01030731|"     The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in     the body, how they are distributed within the body and how they are removed from the body     over time) of ceftobiprole after a single 250-mg intravenous (IV) infusion (given directly     into the vein) for 2 hours, before and after dialysis to patients with end-stage renal     disease (ESRD) requiring hemodialysis or healthy volunteers.   "
243105|NCT01030744|"     The broad, long-term objectives are to generate and test hypotheses leading to theories that     guide improved care of patients with gestational diabetes. The purpose of this chart review     study is to evaluate the Vanderbilt Gestational Diabetes Self-Management Education Program     and Quality Improvement Plan in optimizing metabolic control and improving health outcomes     during pregnancy with gestational diabetes.   "
243106|NCT01030757|"     The purpose of this study is to determine the response of liver tumors to radiation therapy     using Tomotherapy.   "
243107|NCT01030770|"     This study will enrol patients with diabetes who have already elected to undergo pars plana     vitrectomy (eye surgery) to remove persistent vitreous haemorrhage (a complication of severe     diabetic eye disease in which blood fills the inner cavity of the eye, obscuring the vision     and preventing treatment to stop the bleeding). Those in the treatment arm will have an     intravitreal injection of ranibizumab (Lucentis) at the same dose used for the treatment of     neovascular (wet) age-related macular degeneration (a disease that has some features in     common with diabetic eye disease).      It is hypothesised that this will promote clearance of the vitreous haemorrhage and that     this, in turn, may mean that some patients do not need to proceed to vitrectomy.   "
243108|NCT01030783|"     This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm     trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed     to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health     outcome measurements of tivozanib and sorafenib.   "
243109|NCT01030796|"     This project is a pilot study of caffeine abstinence in coffee-drinkers who have type 2     diabetes. Evidence suggests that caffeine may impair the control of glucose levels,     especially in those people who have type 2 diabetes. Eliminating caffeinated beverages from     the diet might improve glucose control, but the difficulty of quitting is unknown. This pilot     study will follow a small number of type 2 diabetic patients for three months after a brief     intervention designed to help people quit caffeine. Data on success with maintaining     abstinence and on changes in glucose control will be collected.   "
243110|NCT01030809|"     Assess if the implementation of a treatment algorithm will improve the management of Crohn's     disease (CD) in comparison to usual care based gastroenterology practices.   "
243111|NCT01030822|"     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a     booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18     months of age in children primed in primary study NCT00814710.      This study also aims to assess the persistence of antibodies induced following primary     vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to     booster vaccination and following vaccination in the present study at approximately 24 months     of age.      The study is also designed to evaluate the immunogenicity, safety and reactogenicity of     pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the     second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.   "
243112|NCT01030835|"     Background:      - The National Institute of Drug Abuse (NIDA) is interested in developing a pool of potential     research participants who may be eligible for research studies on drug abuse and addiction,     pharmacological and psychosocial therapies for substance addiction, drug abuse and     co-occurring psychiatric disorders, and the long-term effects of drugs on the development,     function, and structure of the brain and other organ systems. To develop this pool of     potential participants, researchers intend to screen individuals who may be eligible for     future research studies.      Objectives:      - To identify, recruit, and screen participants for NIDA collaborative research protocols.      Eligibility:      - Individuals 18 years of age and older who are able to provide informed consent.      Design:        -  Eligible participants will undergo two screening interviews: a telephone interview and          an in-person interview. The phone interview will determine eligibility for the in-person          interview.        -  The in-person interview, which may require up to five visits to the clinical center,          will involve any or all of the following procedures: (1) full physical examination and          medical history; (2) psychiatric interview; (3) psychological testing; (4)          electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally          invasive procedures as directed by the research staff.        -  Participants will provide a photograph for confirmation of identity for subsequent          visits and protocols.        -  No clinical care will be provided under this protocol.   "
243113|NCT01030848|"     The objective of this prospective study is to determine (1) the time course of     patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome     Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following     TKR using the LCS rotating platform prosthesis. Improvement of patient self-reported pain and     daily function during the study period, are of particular interest.   "
243114|NCT01030861|"     The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to     prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very     high risk for developing the disease. Teplizumab has been studied in new onset type 1     diabetes for testing of efficacy and safety in previous studies; other studies are currently     in progress. The results of previous studies indicate that teplizumab reduces the loss of     insulin production during the first year after diagnosis in individuals with type 1 diabetes.     The purpose of this study is to determine if teplizumab can interdict the immune process that     causes the destruction of insulin secreting beta cells in the pancreas during the     pre-diabetic state and thereby prevent or delay the onset of type 1 diabetes.   "
243306|NCT01040429|"     The purpose of this study IS to        -  explore the underlying pathophysiology of chronic fatigue syndrome (CFS) in adolescents,          particularly focusing on genetics, infections/immunology, endocrinology, autonomic          control and cognitions        -  to assess the effect of clonidine (a drug that attenuates sympathetic nervous activity)          in adolescent CFS.   "
243115|NCT01030874|"     For patients recovering from acute illness, the ability to stand, walk, climb stairs, and     participate in therapy are critical to their recovery and eventual discharge to the least     restrictive environment. Orthostatic hypotension is a common finding in medically ill adult     and elderly patients and is a potentially reversible contributor to functional impairment.     This 4-year project will be a randomized controlled trial of a     multidisciplinary-multicomponent intervention to determine whether routine identification and     treatment of OH improves functional outcomes such as: balance, fall rates, therapy     participation, length of stay, transfer to acute care hospital, and discharge location.     Routine screening and management of OH may improve outcomes for rehabilitation and long term     care patients, as well other high-risk patient populations.   "
243116|NCT01030887|"     Many cancer survivors suffer symptoms such as fatigue and dyspnea which may persist for years     or months after their chemotherapy has finished. Despite the known benefits of exercise and     its potential to address many of the symptoms after cancer, the type of practical exercise     programme which best suits this population is not known.      Many exercise programmes performed in cancer survivors take place over many weeks or months     and include people with specific types of cancer. Such programmes may therefore not be     suitable for the majority of cancer survivors and would pose serious practical difficulties     with high drop-out rates and expensive resource consumption if they were extended into     clinical practice.      We propose to run an 8-week exercise intervention in a mixed cancer population.      Hypothesis: A brief, individually tailored 8-week intervention will increase fitness and     improve other physical symptoms in a mixed cancer survivor population after chemotherapy.   "
243117|NCT01030900|"     Background:        -  Studies conducted at the National Cancer Institute suggest that certain chemotherapy          drugs may be more effective if given by continuous infusion into the vein rather than by          the standard method of rapid intravenous injection. One combination of six chemotherapy          drugs, known as EPOCH-R, has had a high degree of effectiveness in people with certain          kinds of cancer.        -  Recent evidence also indicates that the effects of chemotherapy may be improved by          combining the treatment with monoclonal antibodies, which are purified proteins that are          specially made to attach to foreign substances such as cancer cells. A monoclonal          antibody called campath (alemtuzumab) has been manufactured to attach to a protein          called CD52 that may target tumor cells or the surrounding inflammatory cells.        -  Researchers are interested in developing new treatments for large B-cell lymphoma or          Hodgkin lymphoma that can best be treated with chemotherapy. This protocol is          specifically for people with diffuse large B-cell or Hodgkin lymphomas that have not          responded to standard treatments.      Objectives:      - To test whether giving campath (alemtuzumab) in combination with continuous infusion     EPOCH-R chemotherapy will improve the outcome of lymphoma treatment.      Eligibility:      - Individuals 18 years of age and older who have large B-cell lymphoma or Hodgkin lymphoma     that has not responded well to standard treatments.      Design:        -  During the study, patients will receive standard EPOCH-R chemotherapy, which includes          the following drugs: etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin,          and rituximab. The additional drug, campath, will be given by IV infusion on the first          day of treatment over several hours.        -  When the campath IV infusion and rituximab IV infusion are complete, the drugs          doxorubicin, etoposide, and vincristine will each be given by continuous IV infusion          over the next 4 days (that is, continuously for a total of 96 hours). Cyclophosphamide          will be given by IV infusion over several hours on Day 5. Prednisone will be given by          mouth twice each day for 5 days.        -  Patients may be given other drugs to treat the side effects of chemotherapy, to prevent          possible infections, and to improve white blood cell counts.        -  The campath-EPOCH-R therapy will be repeated every 21 days, as a cycle of therapy, for a          total of 6 cycles. Following the fourth and sixth treatment cycles (approximately weeks          12 and 18) of campath-EPOCH-R treatment, study researchers will perform blood tests and          CT/MRI scans on all patients to assess their response to the treatment.   "
243118|NCT01030913|"     B type chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the western     world. It is a disease that occurs primarily in aging individuals and occurs more frequently     in males than females. Although B-CLL was considered a homogeneous condition, recent studies     by our laboratory and others suggest that B-CLL cases can be divided into two subgroups.      These sub-groups can be identified by either the presence or the absence of mutations in     antibody genes and/or by the percentage of B-CLL cells expressing a particular protein called     CD38. These two sub-groups (unmutated antibody genes high percent CD38 and mutated antibody     genes low percentage CD38) follow strikingly clinically different courses. For example, the     unmutated/CD38+ group experiences a much more aggressive disease and these patients almost     invariably die much sooner than the cases in the other group. In addition, the patients in     the mutated CD38+ group require much more chemotherapy than mutatedlCD38-. Finally,     surprisingly there is a much higher representation of males in the poor outcome unmutated     CD38 group than in the better outcome group. The reasons for these differences in clinical     outcome and gender bias are unknown.   "
243119|NCT01030926|"     This trial was conducted in Europe. The aim of this clinical trial was to look into the     concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of     NN1250 in children, adolescents and adults with type 1 diabetes.   "
243120|NCT01030939|"     The purpose of this study is to determine whether SB-649868 is safe, tolerable after repeated     administrations in adult and elderly healthy volunteers. Pharmacokinetics and effects on     cardiac function of repeated doses are studied   "
243121|NCT01030952|"     A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to     compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese     drug-naive patients type 2 diabetes mellitus (T2DM). In this study, participants in different     groups took Nateglinide at a dose of 120 mg orally three times daily for up to 3 weeks or     Acarbose at a dose of 50 mg three times daily for up to 3 weeks, respectively.   "
243122|NCT01030965|"     The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with     placebo in subjects with COPD   "
243123|NCT01030978|"     The purpose of this study is to determine if the Bright Bodies (BB) Healthy Lifestyle Program     can help reverse early abnormalities in glucose metabolism and prevent the progression to     type 2 diabetes (T2DM) in high-risk, obese youth with newly-diagnosed impaired glucose     tolerance (IGT).   "
243124|NCT01030991|"     The purpose of this study is to create a classification system for the heterogenous disorder     of heart failure with preserved ejection fraction (HFpEF).   "
243125|NCT01031004|"     This study is intended to show that the investigational contact lens is clinically equivalent     to a currently approved contact lens, when worn as single-use on a daily basis.   "
243126|NCT01031017|"     Twin pregnancies are at substantial increased risk of preterm delivery. Prophylactic     administration of progesterone in singleton pregnancies at risk of preterm delivery has been     shown to be effective in reducing the rate of such complication. The aim of this study is to     investigate the effect of prophylactic administration of natural progesterone in twin     pregnancies on the rate of preterm births.   "
243185|NCT01031797|"     QT dispersion can be a useful, simple noninvasive method for the early detection of cardiac     involvement in SLE patients with active disease. The investigators therefore recommend     cardiovascular evaluation for every SLE patient with an SLEDAI higher than 10.   "
243127|NCT01031030|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, fluorouracil,     and epirubicin hydrochloride, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. It is not yet known whether     giving cyclophosphamide together with methotrexate and fluorouracil before, after, or without     epirubicin hydrochloride is more effective in treating patients with breast cancer that can     be removed by surgery.      PURPOSE: This randomized phase III trial is comparing three regimens of cyclophosphamide     given together with methotrexate and fluorouracil, with or without epirubicin hydrochloride,     to see how well it works in treating women who have undergone surgery for breast cancer.     (Group III was closed to new patients as of 12/7/2009.)   "
243128|NCT01031043|"     The purpose of this research project is to determine the effect of a drug called bethanechol     on swallowing function in patients with Ineffective Esophageal Motility (IEM). This drug is     FDA approved for use in treating other conditions, but not for the treatment of IEM. There is     currently no approved therapy for the treatment of IEM. This information is important for the     possible development of new ways of treating patients with IEM and for the effectiveness of     topically applied Bethanechol on patients with IEM.   "
243129|NCT01031056|"     We have an active research program in gastrointestinal cancers including clinical trials,     epidemiologic, and translational studies. We would like to establish a biospecimen bank     linked to useful clinical information in order to learn more about diagnostic, predictive and     prognostic markers for gastrointestinal cancers.      PRIMARY OBJECTIVES:      1. To collect and store tumor and normal tissue (previously collected paraffin embedded or     frozen specimen) and blood in patients with gastrointestinal (GI) cancers.      SECONDARY OBJECTIVES:        1. Collect detailed clinical information via a patient questionnaire that includes          demographic, socioeconomic, lifestyle, family, past medical, medication and cancer          histories        2. Collect details about the tumor specimen extracted from patient charts.   "
243130|NCT01031069|"     Infection with human papillomavirus (HPV) has been clearly established as the central cause     of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety     and immunogenicity of Cervarix™ in HIV infected females aged 15 to 25 years as compared to     Merck's HPV vaccine (Gardasil®). For comparative purposes, a group of HIV negative females     will also be evaluated. All subjects will receive the HPV vaccine (either Cervarix™ or     Gardasil®) according to a three-dose schedule (Day 0, Week 6, Month 6).   "
243131|NCT01031082|"     The purpose of this study is to identify and characterize the bacteria causing acute otitis     media episode in HIV-positive and HIV-negative children (>=3 months to <5 years) in South     Africa. Middle ear fluid sampling either by tympanocentesis or by careful sampling of     spontaneous otorrhoea will be done; nasopharyngeal aspirate and urine sample will also be     collected from the subjects.   "
243132|NCT01031095|"     The hypothesis:      Low dose intracoronary unfractionated heparin is as effective and safe as standard dose     intravenous unfractionated heparin on patients with elective percutaneous coronary     intervention.   "
243133|NCT01031108|"     The primary purpose of this study is to evaluate the safety and tolerability of SRT2104 (2.0     g administered once daily for 28 days) and to examine the effects of SRT2104 (2.0 g     administered once daily for 28 days) on reversing vasomotor and fibrinolytic dysfunction in     both type 2 diabetes mellitus patients and otherwise healthy cigarette smokers in a fed     state.      This study will investigate the effects of SRT2104 on the reduction of platelet activation     markers (platelet-monocyte aggregates), and to evaluate the effects of SRT2104 on platelet     and monocyte surface markers (P-selectin, CD11b), inflammatory markers (high sensitivity CRP,     IL-6, SAA, TNF-α and sCD40L), and markers of oxidative stress (urinary and plasma     F2-isoprostanes and nitrotyrosine).      Further goals of this study is to characterize the pharmacokinetic profile of SRT2104 after a     single dose and multiple administrations in both type 2 diabetes mellitus patients and     otherwise healthy cigarette smokers in a fed state, and to explore the effects of SRT2104 on     potential biomarkers of activity for glucose control (HbA1c, glycated albumin and     fructosamine) and/or Sirt1 activation.   "
243134|NCT01031121|"     Background:        -  Self-report and biochemical verification are used to determine smoking status in          treatment trials and clinical research. Each method has merits and limitations that make          it appropriate for particular situations. Participants who feel social pressure to          report tobacco abstinence may provide unreliable self-reporting results. Biochemical          verification using breath carbon monoxide (CO) is a more reliable indicator, but several          biological and environmental factors (including exposure to secondhand smoke) can affect          the sensitivity and specificity of breath CO measurement.        -  An ideal biomarker of smoking status is cotinine, the major metabolite of nicotine.          Cotinine levels found in blood, urine, and saliva can be used to distinguish between          smokers and nonsmokers, as well as between light and heavy smokers. Researchers are          interested in using cotinine assessments to develop suitable breath CO cutoff levels to          categorize different types of smokers and nonsmokers for use in future research.      Objectives:      - To determine a breath carbon monoxide (CO) cutoff level that optimally discriminates     between heavy and light smokers and nonsmokers who are and who are not exposed to     environmental tobacco smoke.      Eligibility:        -  Individuals between 18 and 64 years of age who fall into one of the following groups:        -  current smokers reporting more than 10 cigarettes per day for at least 6 months        -  current smokers reporting 10 or fewer cigarettes per day for at least 6 months        -  nonsmokers reporting regular environmental exposure to tobacco smoke        -  nonsmokers reporting limited or no exposure to tobacco smoke      Design:        -  The study will involve a single outpatient session.        -  Participants will provide breath CO, urine, and saliva samples, and will complete          several smoking-related questionnaires on smoking history, current craving levels, and          perceived level of nicotine dependence.   "
243135|NCT01031134|"     Shared decision-making (SDM), in contrast to traditional medical decision-making, involves a     collaborative process where patients discuss personal values and preferences and clinicians     provide information to arrive at an agreed upon treatment decision. The proposed study will     evaluate the impact of a brief SDM nursing intervention among elderly, depressed primary care     patient subjects in comparison to physician recommended Usual Care. The focus of the SDM     intervention is to empower depressed patients and help them arrive at a treatment decision     that can be successfully carried out.   "
243136|NCT01031147|"     The Chinese Cerebral Aneurysms Survey is a continuing prospective study to evaluate the     effectiveness of unenhanced, three-dimensional time-of-flight magnetic resonance angiography     (3D-TOF-MRA) with volume rendering (VR) at 3-T in the detection of intracranial aneurysms.   "
243186|NCT01031810|"     The primary objectives of the study are to test whether brain Mono Amine Oxidase-A (MAO-A)     levels are elevated in patients with treatment-resistant major depression, and to explore     whether MAO-A brain levels predict treatment outcome with Mono Amine Oxidase Inhibitor (MAOI)     medication in this population.   "
243137|NCT01031160|"     NEXT is a seven-year longitudinal assessment of a representative sample of U.S. adolescent     and young adults starting at grade 10. The goals of the NEXT longitudinal study include: to     identify the trajectory of adolescent health status and health behaviors from mid-adolescence     through the post high school years; to examine individual predictors of the onset of key     adolescent risk behaviors and risk indicators during this period; to identify genetic,     personal, family, school, and social/environmental factors that promote or sustain positive     health behaviors; to identify transition points in health risk and risk behaviors and changes     in family, school, and social/environmental precursors to these transitions, and to examine     the role of potential gene-environment interactions in the development of health status and     health behaviors.      This study collects reliable and valid data on health behaviors and health indicators and     their social, environmental, and biological contexts beginning with a nationally     representative probability cohort of 10th-grade children in the U.S in 2010 and following     them through 2016. Measures are collected annually for seven years beginning in the 2009-2010     school year. African-American youth are oversampled to provide better population estimates of     this group and to provide an adequate sample to examine racial/ethnic differences in     longitudinal predictors of health, health behaviors, and health behavior change. Hispanic     youth do not require oversampling because they currently represent a sufficient proportion of     the population of adolescents to provide an adequate sample to examine racial/ethnic     differences. Self-reports of health status, health behaviors, and health attitudes are     collected by in-school and online surveys. Anthropometric data, genetic information, and     neighborhood characteristics are gathered on all participants as well. The study also     incorporates an Administrator Survey and other data sources to obtain related information on     school-level health programs and community-level contextual data. The NEXT Generation Health     Study data support NICHD, National Heart, Lung and Blood Institute (NHLBI), National     Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA)     and the Maternal and Child Health Branch of the Health Resources and Services Administration     (HRSA/MCHB) in fulfillment of program requirements that address supportive health     environments for adolescents and young adults. In addition, a representative subsample of     overweight and normal weight adolescents has been identified: additional data on behavioral     risk factors and biological markers and risk factors are gathered on these adolescents.     Driving performance will also be evaluated in 150 young adults.   "
243138|NCT01031173|"     The study will evaluate the safety and efficacy of Replagal® (agalsidase alfa) at a dose of     0.2 mg/kg infused intravenously (IV) over 40 minutes, every other week. The study will     monitor the course of disease in males and females with Fabry disease who are naive to     treatment or were previously treated with agalsidase beta (Fabrazyme®).   "
243139|NCT01031186|"     This study will evaluate the safety, tolerability, and pharmacokinetics of GSK356278 in male     volunteers   "
243140|NCT01031199|"     PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with     Multiple Sclerosis compared to healthy volunteers   "
243141|NCT01031212|"     This phase I trial is studying the side effects and best dose of an investigational drug     called DMXAA (5-6-dimethylxanthenone-4-acetic acid) or ASA404 when given together with     carboplatin, paclitaxel and cetuximab to treat patients with refractory solid tumors.   "
243142|NCT01031225|"     This is a phase 2 study of the HSP90 inhibitor, STA-9090 (ganetespib) in subjects with stage     IIIB or IV non-small cell lung cancer (NSCLC).   "
243143|NCT01031238|"     The goal of this clinical research study is to learn if using the PEMFlex Solo II, a     high-resolution camera for positron emission tomography (PET) scan imaging, on an area of the     body that has, or is suspected to have cancer will give researchers the same or better     information about the disease compared to the images taken with a routine PET/computed     tomography (CT).      Researchers will compare the images taken using the PEMFlex Solo II to the images taken     during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s),     magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within     the last 30 days or may have in the next 30 days.   "
243144|NCT01031264|"     Alcoholism is among the top three causes of preventable death and disease in the US (Mokdad     et al., 2004; Room et al., 2005). Stress plays an important role in the development of     alcoholism and in high vulnerability to alcohol relapse. This study will provide a greater     understanding of the mechanism by which stress and alcohol consumption interacts to influence     development of compulsive alcohol seeking and vulnerability to stress-induced drinking, and     the results will have significant implications for the development of new prevention and     treatment interventions for alcoholism.   "
243145|NCT01031277|"     The purpose of the study is to establish the proportion of patients on lipid-lowering     pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004     NCEP ATP III guidelines, overall and by country, to establish the proportion of patients on     lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP     III/updated 2004 NCEP ATP III in the following sub-populations:        -  Primary/secondary prevention patients.        -  Patients with metabolic syndrome (according to NCEP III definition). And to establish          the proportion of patients on lipid-lowering pharmacological treatment reaching the          LDL-C goals according to the Third Joint European Task Force guidelines/national          guidelines, in the survey population and in the following sub-populations:             -  Primary/secondary prevention patients.             -  Patients with metabolic syndrome.   "
243146|NCT01031290|"     Background:        -  Cannabis, also known as marijuana, is a commonly abused drug. There is no approved          medication to treat cannabis addiction. The desire to use cannabis often increases when          seeing others use it or seeing pictures of it. Researchers are interested in determining          which parts of the brain are active when looking at pictures associated with cannabis.        -  Repetitive transcranial magnetic stimulation (rTMS) uses magnetic pulses to stimulate          the brain. These pulses can change activity in parts of the brain. Researchers are          interested in determining whether rTMS can decrease activity in the parts of the brain          that respond to cannabis, and thereby lessen cravings for cannabis.      Objectives:      - To determine whether transcranial magnetic stimulation can lower craving for cannabis when     people who use cannabis are shown images that increase craving.      Eligibility:      - Individuals 18 years of age and older who are physically healthy and currently use cannabis     (at least 3 times weekly for the past 2 years).      Design:        -  The study will involve eight visits over 3 weeks, with each visit lasting 1 to 2 hours.        -  Participants will have an initial assessment about cannabis use and provide blood and          urine samples before beginning the study.        -  Participants will have three magnetic resonance imaging (MRI) brain scans. The first MRI          scan will look at the structure of the brain at rest. During the other two scans,          participants will look at images related to and not related to cannabis use.        -  The rTMS sessions (with either actual TMS or inactive [sham] TMS) will be held daily for          5 consecutive days. During these testing visits, researchers will ask questions related          to drug use and craving, and collect urine and breath samples for further study.        -  Participants will have two follow-up visits, 1 week and 2 weeks after the rTMS sessions,          to evaluate memory and mood, and one final MRI brain scan at the end of the study.   "
243187|NCT01031823|"     This study is a pre-test, post-test single group design with follow-up at month three.     Twenty-four individuals total will participate in this study with 6 participants in each of 4     cohorts. Participants and their parents will complete pre-test measures including both paper     and pencil measures and a video-recording to assess the participant's social interaction     skills and fluency. These adolescents will participate in both group therapy and peer     generalization sessions once a week over the course of twelve weeks. Upon completion of the     intervention, participants and parents will complete paper and pencil and video post-test     measures. Participants will be encouraged to participate in one follow-up session where the     paper and pencil and video measures will be completed again.   "
243188|NCT01031836|"     The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese     adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1     cohort of SC doses.   "
243147|NCT01031303|"     The purpose of this study is to provide further immunogenicity and safety information of     sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and     6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi     pasteur DTacP-IPV// PRP~T vaccine (PENTAXIM™) as a three-dose primary and booster     vaccinations.      Primary Objective :        -  To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio          types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis          antigens (Pertussis toxoid [PT], Filamentous Haemagglutinin [FHA]) of sanofi pasteur's          DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of          age.      Secondary Objectives :        -  To describe the antibody persistence in terms of anti-pertussis antibody levels          (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria,          Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose          (at Visit 1) in all subjects at 4-6 years of age.        -  To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio          types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis          antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after          administration of the booster dose given at 4 to 6 years of age.        -  To describe the safety after the booster dose of the study vaccine.   "
243148|NCT01031316|"     The ductus arteriosus directs blood away from the pulmonary circulation and toward the     systemic circulation during fetal life, then closes after birth. In preterm infants the     incidence of spontaneous closure decreases with gestational age. Patent ductus arteriosus     (PDA) increases the risks of bronchopulmonary dysplasia (BPD) and necrotizing enterocolitis     (NEC). However, this association may not be a causal relationship.      Echocardiography is required to diagnose PDA. However, routine screening echocardiograms lead     to detection of asymptomatic PDAs, for which the benefit of therapy remains unproven.      A randomized controlled trial has been designed in which 88 infants with birth weight less     than or equal to 1250 grams and gestational age less than or equal to 30 weeks will be     enrolled. The investigators' goal is to determine how screening echocardiography influences     clinical management and outcomes in these infants.   "
243149|NCT01031329|"     The purpose of this study is to identify and characterize the bacteria causing complicated     Acute Otitis Media episode in children >= 3 months to < 5 years in Turkey.   "
243150|NCT01031342|"     Study hypothesis is that performing early colonoscopy in patients who present to the hospital     with lower GI bleeding improves their outcome.      Patients who are admitted with bleeding from their rectum and a negative endoscopic exam of     the stomach and upper intestine are randomized (like flipping a coin) to receive a     colonsoscopy either as an emergency (within 12 hours) or as a routine procedure (36 hours     after admission). Patients are followed during their hospitalization to see if they have     further bleeding, if they require blood transfusions, if they need other diagnostic tests, if     they need surgery or other treatments, and how long they stay in the hospital.   "
243151|NCT01031355|"     Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of     one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium     as compared to one film-coated tablet containing 3 mg Estradiol Valerate Investigation of the     bioequivalence of levomefolate calcium after administration of one film-coated tablet     containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one     film-coated tablet containing 0.451 mg levomefolate calcium   "
243152|NCT01031368|"     This phase I trial is studying the safety and potential efficacy of infusing non-human     leukocyte antigen (HLA) matched ex vivo expanded cord blood progenitors following treatment     with clofarabine and cytarabine for patients with acute myeloid leukemia (AML). The     combination of clofarabine, cytarabine (Ara-C) and granulocyte colony-stimulating factor     (G-CSF) has been tested in earlier studies for the treatment of acute myeloid leukemia. In     these previous clinical trials, this combination of drugs has been shown to have an     anti-leukemia effect. However, the combination of clofarabine and Ara-C is profoundly     myelosuppressive and immunosuppressive causing periods of neutropenia potentially lasting     more than three weeks. During this period, patients are at increased risk of infections that     can result in an increased risk of death. G-CSF is a growth factor that is used to help the     white blood cells recover more quickly, but even with G-CSF, the use of clofarabine and Ara-C     is often limited by the need to take long breaks between treatments to allow blood counts to     recover. In our lab we have developed a method of growing or expanding blood stem cells     (cells that give rise to the blood system) from umbilical cord blood. We are doing this study     to find out if giving these expanded cells after chemotherapy is safe, helps the blood system     recover more quickly from chemotherapy to allow shorter breaks between treatments, and     decreases the risk of infection   "
243153|NCT01031381|"     This study will investigate the efficacy as well as the safety of RAD001 in combination with     bevacizumab for recurrent ovarian, peritoneal, and fallopian tube cancer. RAD001 will be     taken orally once daily and bevacizumab will be administered once every 14 days. The study     will be conducted over a period of about 3 to 4 years.   "
243154|NCT01031394|"     The objective of this study is to provide insight into the effects combined training     frequency has on improving fitness, ease of physical activity, and maintenance of a high     total energy expenditure. Such information is critical to our understanding of ways to     improve well-being, quality of life, and independence of an aging population. 105     participants will be enrolled in this study. The length of time for your involvement in the     study will be 32 weeks. You will undergo the procedures listed in this consent form on 3     separate occasions-initially at your entry, at 16 weeks and again at 32 weeks.   "
243189|NCT01031849|"     The objective is to analyse the changes in the adipose tissue hystological features and the     adipogenesis gene expression and related to inflammation after 48 and 96 weeks after the     change from AZT+3TC+ABC (Trizivir®) to a monotherapy treatment with LPV/r (Kaletra®)   "
243190|NCT01031862|"     The purpose of this study is to investigate the use of radiolabeled particulate cholesterol     administered intravenously in association with albumin, as a method to study reverse     cholesterol transport (RCT) in humans by analyzing changes in the tracer activity in total     plasma, lipoproteins and feces.   "
245072|NCT01068730|"     To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by     BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in     Australia by Alphapharm in the fed state   "
243155|NCT01031407|"     Background:        -  Autism spectrum disorders (ASDs) are a group of developmental disorders that affect          communication, social interaction, and behavior. Relatively little is known about the          relationship between genetics and behavior among these individuals and their close          relatives. Researchers are interested in using interviews and rating scales to better          understand these issues, as well as collecting brain scan data and genetic samples for          testing and comparison.        -  By comparing test results and genetic samples from healthy volunteers, people with ASD,          and parents (or caregivers or legal guardians) of the first two groups, researchers hope          to better understand the neuroscience of ASD.      Objectives:        -  To learn more about the brain in healthy people and in people with autism spectrum          disorders.        -  To study genes that might be involved in autism spectrum disorders by collecting DNA          samples from participants.      Eligibility:      The following groups of participants will be eligible for the study:        -  Individuals between 5 and 89 years of age who have autism spectrum disorders.        -  Healthy volunteers between 5 and 89 years of age.        -  Cognitively impaired children between 5 and 17 years of age.        -  Parents/caregivers/legal guardians of individuals in the above three groups.      Design:        -  Participants will visit the National Institutes of Health Clinical Center for research          tests, which will be administered over multiple visits. Researchers will determine the          specific tests to be administered based on the medical history of the study participant.        -  Researchers will study the brain through interviews, tests of thinking and memory          (neuropsychological tests), brain imaging with magnetic resonance imaging (MRI), and          magnetoencephalography (MEG).        -  The study will also collect blood or saliva to obtain a DNA sample.   "
243156|NCT01031420|"     Standard treatment for early stage bladder cancer is chemotherapy with methotrexate (M),     vinblastine (V), adriamycin (A), and cisplatin (C) followed by surgical removal of any     remaining cancer and the bladder with the intent of cure. The MV chemotherapy is usually     given every 14 days with the AC given along each 28 days. This study looks at giving the same     drugs at the same doses closer together, all drugs every 14 days, with the support of growth     factor medication to promote growth of the white blood cells and platelets and allow     chemotherapy to be finished sooner and surgery to be done sooner.   "
243157|NCT01031433|"     Background:        -  The prevalence of cigarette smoking among individuals with schizophrenia is noticeably          higher than in the general population, and smoking cessation attempts frequently are          unsuccessful in this population. Little is known about the effects of cigarette/nicotine          craving in individuals with schizophrenia. Researchers are interested in learning more          about how craving affects people with schizophrenia and developing new ways to treat          cravings and improve the effectiveness of smoking cessation therapies and treatments.        -  In recent years, virtual reality (VR) has been studied to determine whether it can be          used to induce craving by using life-like cue settings. VR cues involving cigarette use,          including images of cigarettes and scent cues of tobacco smoke, may be used to elicit          craving in smokers. Researchers are interested in learning more about how individuals          with schizophrenia respond to specific VR cues and settings.      Objectives:        -  To determine the feasibility of using a contextual real-world paradigm using virtual          reality involving cigarette smoking in people with schizophrenia.        -  To examine if virtual reality cues will elicit craving in smokers with schizophrenia.      Eligibility:      - Current smokers (five or more cigarettes per day for at least 1 year) between 18 and 45     years of age who have been diagnosed with schizophrenia/schizoaffective disorder.      Design:        -  The study will involve three sessions, with an initial screening visit, a test session,          and a follow-up session.        -  Screening visit: Participants will be screened with a medical and psychiatric history,          and will answer questions about smoking history, current smoking habits and craving          patterns, and general anxiety levels. This session will also introduce participants to          the operation and use of the VR equipment. Participants who are comfortable using the VR          system will return within 2 days for the test session.        -  Test session: Participants will use the VR equipment to view neutral scenes and scenes          that are designed to elicit cravings for cigarettes. After viewing each scene,          participants will answer questions about their overall mood, anxiety levels, and any          cigarette cravings they may have.        -  Follow-up session: Participants will return 1 week after the VR session to answer          questions about mood, anxiety levels, and current smoking habits and craving patterns.   "
243158|NCT01031446|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving cisplatin and     paclitaxel together with everolimus may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin and     paclitaxel together with everolimus and to see how well it works in treating patients with     metastatic breast cancer.   "
243159|NCT01031459|"     The purpose of this study is to investigate the clinical status of patients who participated     in the original pivotal Betaseron study at 20 years after randomized treatment     initiationStudy end-points include:        1. Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related          mortality        2. EDSS (Expanded Disability Status Scale)        3. Cognition        4. Resource use        5. SPMS (Secondary Progressive Multiple Sclerosis) status        6. Employment history   "
243160|NCT01031472|"     This is a single-center, randomized, two part, open-label, crossover study in healthy adult     subjects to assess the effect of up to three formulations on the relative bioavailability of     GSK2248761 100mg administered with and without food. Part A will evaluate two new     formulations compared to the current formulation. Part B will evaluate one additional     formulation if the bioavailability of the two formulations in Part A do not meet     pre-specified criteria. Safety evaluations and serial PK samples will be collected during     each treatment period. A follow-up visit will occur 7-10 days after the last dose of study     drug.   "
243161|NCT01031485|"     The purpose of this study is to investigate the effects of bioactive milk peptides on blood     pressure in mildly hypertensive subjects.   "
243162|NCT01031498|"     The goal of this clinical research study is to compare the effectiveness of 3 drug schedules     in preventing chemotherapy-related nausea and/or vomiting in patients with acute myelogenous     leukemia (AML) or high-risk myelodysplastic syndrome (MDS).   "
243163|NCT01031511|"     Cognitive Behavioural Therapy is an effective intervention program for children with     High-Functioning Autistic Spectrum Disorder to remediate anxiety issues.   "
243164|NCT01031524|"     Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized     to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or     ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers     are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum.     The main outcome will be the length of time between artificial challenge and development of     blood stage parasitaemia detected by microscopy performed twice a day.   "
243191|NCT01031875|"     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works in treating     patients with or metastatic urothelial cancer or bladder cancer that has relapsed or not     responded to treatment.   "
243232|NCT01039467|"     The COMPARE-Adapta study is a randomized, multi-center, prospective study conducted in China.     The purpose of the study is to compare the ability of Search AV™+ and Managed Ventricular     Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients. The     COMPARE-Adapta study will also observe atrial fibrillation (AF) burden as demonstrated by     Cardiac Compass® and the clinical profile Adapta® pacemaker patients.   "
243165|NCT01031537|"     Background:        -  Infection by tick-borne encephalitis virus (TBEV) is a significant health concern for          humans in Europe and Asia. A vaccine is available in these regions and in Canada, but          not in the United States. Research studies in Europe have shown the vaccine to be          effective in preventing infection among the general population, where disease is          transmitted either by the bite of an infected tick (most common) or by ingestion of          contaminated unpasteurized milk or milk products. Persons who work with the virus in a          research setting, however, have the potential of being exposed in unnatural ways, and          may come into contact with concentrations of virus higher than those found naturally in          ticks.        -  The Food and Drug Administration is investigating the effectiveness of the existing          vaccine. It is a killed vaccine, which means that it has been treated to ensure that it          does not contain live agents (bacteria or virus). The manufacturer has tested the          product for other possible contaminating agents and none have been detected. However,          there is an unknown but small risk of exposure to undetected contaminating agents in the          vaccine.      Objectives:        -  To test the safety and immune response to a vaccine against tick-borne encephalitis          virus (TBEV).        -  To add a level of protection to persons who may have occupational exposure to TBEV to          reduce their chances of developing infection from that exposure.      Eligibility:      - Individuals 18 years of age or older who are in generally good health and have the     potential for occupational exposure to TBEV at one of the two National Institute of Allergy     and Infectious Diseases campuses.      Design:        -  Subjects receiving the full series of the vaccine will receive at least three doses by          injection in the upper arm. The first and third dose of study vaccine will be given in          the muscle of the nondominant arm. The second dose will be given in the dominant arm.        -  Participation will include at least 12 scheduled visits to the study center over          approximately 3.5 years.        -  An initial visit will take place 7 to 21 days prior to the first injection. Blood          samples will be taken to test liver and kidney function, baseline antibody levels, and          for possible pregnancy in female participants.        -  Doses will be given on days 0, 14, and 161. Participants will be asked to complete a          diary card on each day for one week following the vaccination to assess any reactions or          side effects. At each visit after receipt of a vaccine, participants will be asked about          any side effects.        -  Blood will be drawn 14 days after the second injection and 21 days after the third          injection in order to measure the level of antibodies and overall response to the          vaccine.        -  Subjects who develop a sufficiently high level of antibodies may (at the discretion of          the laboratory chief) be allowed to work with strains of TBEV at Biosafety Level (BSL) 3          rather than BSL-4. Blood will be drawn annually for 3 years to determine antibody level          and response to the vaccine. Booster doses will be provided if required.   "
243166|NCT01031550|"     The objective is to examine the efficacy of isoflurane (inhaled anesthetic gas) to induce     clinically effective preconditioning in patients undergoing elective hepatic surgery.   "
243167|NCT01031563|"     Background:        -  Several studies of risk perception have demonstrated a common bias known as unrealistic          optimism, in which individuals feel they are less likely than other people to experience          unpleasant or harmful events in their lives, but more likely to experience pleasant or          beneficial events.        -  Previous research has indicated that individuals with schizophrenia have less of a sense          of unrealistic optimism about adverse events than individuals without schizophrenia.          However, research on risk perception in schizophrenia is sparse, primarily reporting on          behaviors and decisions in the laboratory that likely are influenced by risk perception.        -  Risk perception among substance users may be viewed in two separate categories:          perception of vulnerability to adverse events and perception of vulnerability to          negative outcomes associated with substance use. Research in both areas has yielded          mixed results. Researchers are interested in studying the connections among          schizophrenia, addiction, and risk perception in order to develop better drug use          prevention and treatment programs for people with and without schizophrenia.      Objectives:      - To compare unrealistic optimism bias in people with and without schizophrenia and/or drug     dependence, and its association with actual risky behavior.      Eligibility:        -  Individuals between 18 and 64 years of age who fall into one of the following study          categories:        -  diagnoses of both drug dependence (marijuana or cocaine) and          schizophrenia/schizoaffective disorder        -  diagnosis of drug dependence only (marijuana or cocaine)        -  diagnosis of schizophrenia/schizoaffective disorder only        -  healthy volunteers with no history of drug use or serious mental disorder      Design:        -  The study will require a single visit to the research center for a 5- to 6-hour session.        -  Participants will complete questionnaires on medical and behavioral history, complete          tests of thinking skills like memory and attention, complete a brief computerized          decision-making task, and answer questions about risk perception.        -  Participants will also provide urine samples and breath carbon monoxide measurements to          test for recent use of tobacco and other substances.   "
243168|NCT01031576|"     Osteoarthritis is the result of the degeneration of the cartilage to articulate, being     currently considered as having an multifactorial cause.The knees are one of the affected     joints more due to overload that constitutes the main activator or determinative mechanism     for the development of the illness. Beyond pain it has important reduction of the amplitude     of movement and the muscular force that causes functional limitation and posture's     alterations intervening with the activities of daily life. Therefore, the main objective of     this study will be to characterize the posture's alterations and the electromiographic     activity in patients with osteoarthritis of knees. For this study 30 citizens will be     evaluated, 15 with diagnosis of OA of knees unilaterally and 15 healthful citizens, both the     groups will be of the feminine sex with age between 60 to 80 years. The selected patients     will answer a questionnaire of personal dates and will have an evaluation fiche, in which     will be written down: age, index of corporal mass (IMC), index of Lesquene, index WOMAC     (Western Ontario and Mac Master), personal and familiar date of the diagnosis, antecedents,     instituted treatments, date of the last x-ray, radiological classification of the     osteoarthritis according to Scale of Kellgren, electromiographics date and seeming of the     postural evaluation. For the electromiographic evaluation the activity of the muscles vastus     lateralis and medial oblique in the isometric contraction maximum volunteer (ICMV) and in the     march will be analyzed. And for the postural evaluation will be made three photographs in the     sights previous frontal and sagittal right and left, being that, for the analysis of the     posturais alterations the program will be used SAPO.   "
243169|NCT01031589|"     The purpose of this study is to examine the safety, local tolerability and pharmacokinetics     (how drugs are absorbed in the body, how they are distributed within the body and how they     are removed from the body over time) of a single intramuscular injection (injected directly     in the muscle) of 300 mg (Panel 1) or 600 mg (Panel 2) of a new long acting form of TMC278.     In Panel 3, the safety, local tolerability and pharmacokinetics are being studied after three     successive intramuscular injections (single injection on Day1, single injection on Day15 and     single injection on Day43) of a selected dose of the same TMC278 LA formulation. The dose of     Panel 3 will be determined based on the safety, local tolerability and the pharmacokinetic     results obtained in Panel 1 and 2.   "
243170|NCT01031602|"     Objectives:        -  Assess the prevalence and severity of depression and anxiety in underserved and minority          women seen in the gynecologic oncology clinic at Lyndon Baines Johnson General Hospital.        -  Assess the prevalence and severity of sexual dysfunction in this patient population.   "
243171|NCT01031615|"     The purpose of this study is to determine the efficacy of the Child and Family Traumatic     Stress Intervention (CFTSI) in preventing the development of Posttraumatic Stress Disorder     (PTSD) when implemented within 30 days of a potentially traumatic event.   "
243172|NCT01031628|"     The purpose of this study is to determine if escalating the dose of imatinib to keep the drug     blood level at ≥ 1100 ng/ml leads to better outcomes for patients.   "
243208|NCT01039077|"     Gastric banding has been shown to significantly reduce weight and has been approved as a     treatment of morbid obesity. The standard laparoscopic operation requires five small     incisions for the introduction of instruments and the band into the patient's abdomen. We     have developed a technique for performing this operation through a single incision at the     belly button. This study compares this method to the conventional 5-incision approach.   "
243173|NCT01031641|"     Background:        -  Currently, National Cancer Institute treatment trials use clinical staff reporting to          monitor adverse side effects. The clinical staff reports draw on items from the Common          Terminology Criteria for Adverse Events (CTCAE).        -  Several of the items in the CTCAE can be adapted for use in patient self-reporting of          side effects. Researchers are interested in developing a patient-reported outcome (PRO)          approach to the CTCAE.      Objectives:        -  To develop questions that can be used to create a patient-reported outcome version of          the CTCAE (PRO-CTCAE).        -  To evaluate patient comprehension of and test the usefulness of the PRO-CTCAE questions          among diverse groups of patients.      Eligibility:        -  Individuals 18 years of age and older who are receiving chemotherapy or radiotherapy as          cancer treatment.        -  Participants must be able to speak and understand English.      Design:        -  Researchers will conduct up to three rounds of interviews with patients currently          receiving chemotherapy or radiation therapy treatments for cancer.        -  Participants will be recruited independently from four different clinical treatment          sites. At least 25 percent of patients will have an educational attainment of high          school or less.        -  Each patient will complete a two-part protocol, including a set of PROs that will be          followed by a series of questions to evaluate patient comprehension, memory, perceived          clarity, and judgment of the PROs.        -  The research will be completed in approximately 1 hour, and participants will receive a          small amount of compensation for their time and participation.   "
243174|NCT01031654|"     The purpose of this research study is to examine marital dynamics related to husband-wife     reunification following the veteran's return   "
243175|NCT01031667|"     The purpose of this study is to evaluate the effect of combination therapy with cilostazol     and probucol on plaque volume and composition change in comparison with cilostazol alone by     serial intravascular ultrasound and virtual histology.   "
243176|NCT01031680|"     This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight     and blood pressure, when added to patients existing medications and how it compares with     their usual treatment without added dapagliflozin. Safety data will be collected and analysed     to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have     diabetes, cardiovascular disease and hypertension.   "
243177|NCT01031693|"     Background:        -  Treatment for nicotine addiction is characterized by high rates of relapse. New          treatment therapies for nicotine addiction are exploring the use of brain scanning          equipment to control and decrease nicotine and cigarette cravings.        -  Transcranial magnetic stimulation (TMS) uses magnetic pulses to stimulate the brain.          These pulses can change activity in parts of the brain. Researchers are interested in          determining whether TMS delivered in single pulses can decrease activity in the parts of          the brain that respond to nicotine craving.      Objectives:      - To determine whether single pulse TMS can reduce cue-induced nicotine craving and use in     cigarette smokers.      Eligibility:        -  Individuals 18 years of age and older who are physically healthy and have smoked 10 or          more cigarettes per day for at least 1 year.        -  A small group of healthy nonsmoking control subjects 18 years of age and older will also          participate in the study.      Design:        -  The study will involve seven study visits and two follow-up visits. The control          participants will have only two visits: one with a magnetic resonance imaging (MRI) scan          and one with TMS to evaluate brain function and response.        -  Participants will have an initial assessment about tobacco use habits and craving          patterns, and will provide blood and urine samples before beginning the study.        -  Participants will have two initial MRI brain scans. The first scan will look at the          structure of the brain at rest. During the other scan, participants will look at images          related to and not related to cigarette smoking.        -  The single pulse TMS sessions (with either actual TMS or inactive [sham] TMS) will be          held daily for 5 consecutive days. Magnetic pulses will be triggered by          cigarette-related picture cues and delivered at varying intervals before the participant          sees a cigarette-related picture. During these testing visits, researchers will ask          questions related to tobacco use and craving, and collect urine and breath samples for          further study.        -  Participants will have two follow-up visits, 1 week and 2 weeks after the TMS sessions,          to evaluate memory and mood, and will have one final MRI brain scan at the end of the          study.   "
243178|NCT01031706|"     Previous work demonstrated that inhaled hypertonic saline (HS) reduces exacerbation frequency     and improves lung function in adults with cystic fibrosis (CF). It is unclear, however,     whether HS will benefit young patients suffering from CF. The investigators propose to     further support the concept that HS can benefit children with mild CF lung disease by     performing a relatively short, placebo controlled study of HS in 5-12 year olds, using lung     function and mucociliary clearance as key outcome measures.   "
243179|NCT01031719|"     This is a phase III, randomized, controlled, open label study with two vaccine regimens. The     study will assess the relative safety and immunogenicity of vaccine regimens comparing     adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine     in subjects with Solid Invasive Tumors and to compare safety and immunogenicity data with a     contemporaneously enrolled control group of age-comparable, healthy subjects.      Because certain individuals may be hypo-responsive to influenza vaccination, additional     studies with high-risk groups are warranted in order to determine the optimal vaccine     formulation and dosing schedule for prevention of novel H1N1 virus infection.   "
243180|NCT01031732|"     Current Minimally Invasive THR includes: (1) Minimally Invasive Two-Incision THR (MIS-2),     (2) Minimally Invasive Modified Watson-Jones THR (MIS-WJ). In contrast, mini-incision     utilizes smaller incision (< 10 cm in definition) to perform the THR which can further be     divided into mini-anterolateral (Mini-AL) and mini-posterolateral (Mini-PL).The purpose of     this study is to investigate how MIS THR can affect the results of THR by a prospective     randomized clinical trial. It is hoped that some new standards could be established for the     total hip replacement surgery.   "
243181|NCT01031745|"     Drug use (DU) is a major risk factor for HIV infection in many regions of the world. However,     as highly active antiretroviral therapy (HAART) has been rolled out in South and South East     Asia, less than 2% of individuals initiated on HAART were drug users (DUs) or former DUs,     despite the fact that approximately 20% of HIV infections in the region are ascribed to DU.     India is home to about 2.4 million HIV-infected individuals. Though, injection drug users     contribute to only about 3% of all HIV infections in India; it is estimated that there are     between 168,000 and 1.1 million DUs in India with HIV prevalence about 30%. Novel approaches     are needed to engage disenfranchised populations in HIV care in lower and middle income     countries, where the burden of HIV disease is growing. Incentive-based strategies (or     contingency management) have been shown to be effective in reducing illicit drug use, smoking     cessation, and weight loss. Short-term pilot studies have also shown that incentive-based     strategies can improve electronically-monitored rates of adherence to HAART in the US, and a     recent study in Africa showed that a small incentive approximately doubled the rate that     individuals returned to learn the results of their HIV test. However, to date there is no     experience with the use of incentive-based interventions to improve engagement into care and     risk-reduction among out-of-care HIV-infected DUs in developing world settings. The     investigators propose to conduct pilot randomized trial comparing a voucher incentive     strategy to a control condition to improve engagement in HIV care and HIV treatment outcomes     among out-of-care, treatment-eligible, HIV-infected DUs in Chennai, India. Subjects in the     incentive arm will be eligible to earn incentive vouchers for 1) initiating HAART at a     government-sanctioned HIV treatment clinic, 2) adherence to scheduled follow-up visits at the     HIV clinic, and 3) achieving suppression of HIV RNA. Subjects will be enrolled from a mature     research venue in Chennai, YR Gaitonde Centre for Substance Abuse-related Research (YRGCSAR),     which focuses the epidemiology and natural history of HIV in DUs. Preliminary data from this     pilot study will be used to inform the design of a phase-III study.   "
243192|NCT01031888|"     Topical insulin application has been proved recently to increase corneal reepithelization     rate over diabetic animals. However, its effectiveness on corneal epithelial wound healing in     patients who received pars planar vitrectomy (PPV) for diabetic retinopathy and penetrating     keratoplasty has not been reported. In this study, we plan to perform a prospective     randomized study to determine the effectiveness of topical insulin as a primary treatment for     corneal epithelial defect in patients undergoing vitrectomy for diabetic retinopathy and     penetrating keratoplasty. All patients enrolled in this study have received corneal     epithelial debridement at the end of the ocular surgeries, namely PPV for diabetic     retinopathy and penetrating keratoplasty. The patients were randomized into two treatment     groups. In the control group, the patients receive conventional postoperative eye drops     including topical steroid, antibiotic and mydriatics. In the experimental group, the patients     receive topical insulin eye drops in addition to conventional postoperative eye drops. The     duration for the corneal surface to completely re-epithelize, the incidence of corneal     complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer,     corneal melting, sterile corneal ulcer, corneal neovascularization), and the incidence of     recurrent epithelial break down after initial epithelization will be compared between these     two groups. Patients undergoing PPV for diabetic retinopathy and penetrating keratoplasty     will be compared separately.   "
243193|NCT01038856|"     The primary objective of this study is to determine the overall response rate to erlotinib in     patients with polycythemia vera (PV). Response rate will be assessed by improvement in the     complete blood count, ultrasound of the spleen, and JAK2 molecular status. It is purposed in     this study to explore a possible molecular targeting of the driving mechanism of PV.   "
243194|NCT01038869|"     Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with     skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related     to acne vulgaris. However, it has not been clinically tested for this purpose. The current     study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris     and PIH.   "
243195|NCT01038882|"     The Flexible Bronchoscopy (FB) is a diagnostic and therapeutic procedure which is not usually     tolerated by the patient. This makes the examination more difficult and a repetition of the     examination, if necessary, resulting in a lower diagnostic performance.      Furthermore, there is nowadays little information with a highly obvious level about the     relationship between sedation and the patient´s satisfaction with the FB.      Midazolam is one of the most commonly used sedatives at the beginning for its rapid onset     property and brief duration of action with sedatives, anxiolytics and amnesia properties.      The principal aim of our study is to analyse if the use of a local anaesthetic with midazolam     whilst performing an FB improves the quality of examination in terms of tolerance for the     patient. It would also be of interest to know if there is an improvement in the acceptance of     a second or further FB and if this improves the satisfaction of the Bronchoscopist as far as     the examination performed is concerned.   "
243196|NCT01038895|"     The main objective of this study is to assess the extent and trend in time of antiproteinuric     effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg     daily in hypertensive patients with type 2 diabetes and microalbuminuria. The investigators     will also evaluate:        1. Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks          at various visits        2. Average daytime, as determined by ABPM, systolic and diastolic blood pressure checks at          various visits 3. Average night, as determined by ABPM, systolic and diastolic blood          pressure checks at various visits   "
243197|NCT01038908|"     The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue     dye and the breast drainage system with a radioactive material. By identifying the arm     lymphatics they can be protected during surgery and this may decrease the occurrence of     lymphedema. The information obtained in this study may provide us with better surgical     techniques to identify and protect the arm lymphatic drainage system in the axilla.   "
243198|NCT01038921|"     This trial seeks to compare the effects of melatonin supplementation versus placebo in     subjects with the metabolic syndrome.   "
243199|NCT01038934|"     The aim of this study is to analyze genomic DNA of buccal cytobrush stored in three means     conservation.   "
243200|NCT01038947|"     The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of     single and multiple intramuscular doses of Uricase-PEG 20   "
243201|NCT01038960|"     Interventional study in patients with ICD. Controlled, open intervention with exercise     training. Assessment of changes in physiological and psychological parameters.   "
243202|NCT01038986|"     A post-marketing multi-center observational study to provide data describing the safety and     effectiveness of CUREXCELL™ as it is applied in a real-life setting for treatment in patients     with chronic and/or refractory wounds.   "
243203|NCT01038999|"     The main goal is to confirm, among HIV1-infected patients, data from in vitro studies showing     that antiretroviral therapies induce an accelerated aging through the same mechanisms than     genetic laminopathies or than physiological  aging, that is through the synthesis and     persistence of farnesylated prelamin A. The secondary goal is to measure the impact of HIV     infection and of antiretroviral therapies on markers of cell ageing (proteasome,     mitochondria, telomere). The perspective is to fix antiretroviral therapy side effects using     the same drug combination that will be used in few weeks in Marseille to treat children     suffering from progeria   "
243204|NCT01039012|"     This study will assess the effectiveness of Tai Chi to affect the rate of bone loss in     post-menopausal women who have been diagnosed with the initial stages of bone thinning.   "
243205|NCT01039025|"     To determine the efficacy of high-dose topotecan, cyclophosphamide and melphalan in patients     with Multiple Myeloma.   "
243206|NCT01039038|"     The objective of the trial is to evaluating the feasibility of dose increase by a boost of     curietherapy in PDR (at least 40 Gy on D95) associated to extern radiotherapy (34 Gy) in     intermediate risk in prostate cancer.   "
243207|NCT01039051|"     Previous studies have shown Doing the month, a traditional practice for postpartum women in     China and other Asian countries, may be associated with higher prevalence of postpartum     problems. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes     of diet and lifestyle interventions in Chinese postpartum women.   "
243209|NCT01039090|"     In Parkinson's disease, treatment mainly aims to improve motor functions. However, other     dysfunctions are often observed in Parkinson's patients, and may have important consequences     on the quality of life of patients.      Cognitive and neuropsychological troubles may be observed, as memory impairment or anxiety     for example. As this kind of troubles is worrying for the patient himself (herself) and     his/her family, treatment needs to take into account those troubles in addition to motor     difficulties. In our centre, we have already used continuous Apomorphine infusions among     Parkinson's patients and it seems to have good results. The present study aims to objectively     assess the efficacy of continuous Apomorphine infusions on cognitive and neuropsychological     functions in Parkinson's disease using clinical and positron emission tomography (PET)-scan     measures.   "
243210|NCT01039103|"     Patients with an acute exacerbation of Relapsing-Remitting Multiple Sclerosis or with     Clinically Isolated Syndrome receive either one single infusion of Nanocort or three daily     infusions of SoluMedrol. Main objective is to assess the occurrence of new     gadolinium-enhanced T1-weighted lesions at week 8 vs week 1 after treatment.   "
243211|NCT01039116|"     The purpose of this study was to determine whether once-weekly exposure to a program that     fostered self-esteem building, and improvements in nutrition and physical activity behaviors     would reduce risk of type 2 diabetes in overweight, inner-city, African American children     when compared to a control group.   "
243212|NCT01039129|"     The is a pilot study to evaluate the safety and efficacy of hybrid     transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of     the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the     gallbladder) will be performed through a vaginal incision with an additional small incision     in the umbilicus.   "
243213|NCT01039142|"     In this study, the investigators will intend to compare the efficacy and safety of various     doses of acitretin in a randomized double blind manner in patients with severe plaque-type     psoriasis, by i) studying the change PASI score from baseline as a measure of efficacy ii)     determining the frequency of side effects at various doses. Sixty patients will be recruited     from Psoriasis Clinic of Department of Dermatology, Venerology and Leprology, PGIMER.     Patients will be randomly assigned to one of the three groups: Group A, consisting of 20     patients, will be administered acitretin 25 mg/ day ,Group B, consisting of 20 patients, will     be administered acitretin 35 mg/day and GROUP C consisting of 20 patients, will be     administered acitretin 50 mg/day This therapy will be continued until PSORIASIS AREA AND     SEVERITY INDEX (PASI) scores are reduced to < 25% of the original scores or 12 weeks,     whichever comes earlier. It is expected that acitretin at higher doses will be more     efficacious . As the exact etiopathogenesis of psoriasis is not fully known, it is difficult     to provide a definite cure to all patients, though the disease activity can be controlled to     a great extent with various treatment modalities. However the dosage of acitretin be adjusted     according to response of the patients and tolerability of side effects.   "
243214|NCT01039155|"     This phase I clinical trial studies the side effects and the best dose of azacitidine and     oxaliplatin in treating patients with advanced cancers that do not respond to treatment or     have returned after any platinum therapy. Azacitidine is designed to activate (turn on)     certain genes in cancer cells whose job is to fight tumors. Oxaliplatin is designed to block     the growth and spread of new cancer cells, eventually destroying them, by damaging their     deoxyribonucleic acid (DNA). Giving azacitidine with oxaliplatin may kill more cancer cells     and may also reverse resistance to platinum-based drugs.   "
243215|NCT01039168|"     The study aims to evaluate the effect on return to work of a workplace intervention with     patients being treated for burnout. The intervention intends to reduce job-person mismatch     through patient-supervisor communication.The hypothesis is that the intervention group will     show a more favourable outcome than a control group with respect to return to work.   "
243216|NCT01039181|"     Cholangiocarcinoma (CCA), cancer of the bile duct, is the first cause of cancer death of the     people in the northeast of Thailand. The incidence of CCA in this region is highest not only     in the country but in the world. CCA is a slow growing but highly metastatic tumor. At     present, there is no standard chemotherapy or effective treatment for CCA. Most of the     patients have short survival after diagnosis. Strong evidences from in vitro, animal and     clinical studies indicate that vitamin D can prevent and control growth of cancer. Our     preclinical studies in CCA cell lines, animal and patient tissue culture indicate that     vitamin D effectively reduce growth of CCA. Supplementation of vitamin D to chemotherapeutic     drugs enhance drug toxicity and better response. At present, there are several clinical     trials in USA on supplementation of vitamin D or its analogs to cancer patients. The side     effect or toxicity of using vitamin D supplementation is low, some patients had stable     disease and some had good response. The current study is set up a clinical trial phase II of     vitamin D (calcitriol) in combination with 5-fluorouracil, Mitomycin C and Leucovorin in an     open label-non-randomized study to evaluate the tumor response in patients with advanced     intrahepatic cholangiocarcinoma. This study will provide an alternative/effective     chemotherapy treatment for CCA patients. Better survival and improved quality of life are     also expected.   "
243217|NCT01039194|"     The purpose of the study is to find out if the plasma concentration of galantamine extended     release is changed when BMS-708163 is administered at the same time.   "
243218|NCT01039285|"     Advances in perinatal care have made it possible to improve the survival of the most immature     neonates, but at the cost of an increase in the population at risk of developing     bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of     BPD are not always effective, or related to major side effects. The physiopathological     factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the     use of an exogenous surfactant in neonates presenting with pulmonary disease requiring     mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation     and thus promote pulmonary healing and growth.   "
243219|NCT01039298|"     Oral squamous cell carcinoma (SCC) is a global disease responsible for ~300,000 new cancer     cases each year. Local recurrence (~30% of cases) and formation of second primary malignancy     are common.2, 3 Cosmetic and/or functional compromise associated with treatment of disease     stage is often significant. These statistics underscore the urgent need to develop a better     approach in order to control this deadly disease.      It is becoming increasingly apparent that oral cancers develop within wide fields of diseased     tissue characterized by genetically altered cells that are widespread across the oral cavity     and present in clinically and histologically normal oral mucosa. Complete removal of these     lesions is difficult because high-risk changes frequently go beyond clinically visible tumor.     In recognition of this, current 'best practice' is to remove SCC with a significant width     (usually 10 mm) of surrounding normal-looking oral mucosa. However, since occult disease     varies in size such approach often results in over-cutting (causing severe cosmetic and     functional morbidity) or under removal of disease tissue, as evidenced by frequent positive     surgical margins and high local and regional recurrence - a failure of the 'best practice.      There is a wealth of literature that supports the use of tissue autofluorescence in the     screening and diagnosis of precancers in the lung, uterine cervix, skin and oral cavity. This     approach is already in clinical use in the lung and the mechanism of action of tissue     autofluorescence has been well described in the cervix. Changes in fluorescence reflect a     complex interplay of alterations to fluorophores in the tissue and structural changes in     tissue morphology, each associated with progression of the disease.      As one of the internationally leading teams in applying tissue fluorescence technology, we     have shown that direct fluorescence visualization (FV) tools can identify clinically visible     or occult premalignant and malignant lesions that are associated with lesions at risk, with     high-grade histology and high-risk molecular change. In a recently small scaled,     retrospective study, we have shown that FV helped surgeons in the operating room to determine     the extent of the high-risk FV field surrounding the cancer and resulted in remarkably lower     2-year recurrence rates (0% for FV-guided vs. 25% for those without FV-guided approach).     There is need to design a larger scale prospective, randomized controlled (Phase III) trial     to gather strong evidence in proving the efficacy of the surgery approach using this adjunct     tool.      To establish the evidence supporting the change in clinical practice using FV-guided surgery.     There are 3 objectives.      2.1. Objective 1 (Clinical evidence): To assess the effect of FV-guided surgery on the     recurrence-free survival of histologically confirmed disease within the context of a     randomized controlled trial (efficacy). Hypothesis: FV-guided surgery will increase the     recurrence-free survival.      2.2. Objective 2 (Quality of Life evidence): To establish the cost per recurrence prevented     for this approach and assess quality of life issues. Hypothesis: FV-guided surgery can be     delivered in a cost effective manner and improve the quality of life of patients 2.3     Objective 3 (Scientific/Molecular evidence): To assess the presence of previously validated     molecular markers (microsatellite analysis, LOH) and histological change (quantitative     pathology) in surgical margins in a nested case-control study involving a tumor bank created     within this project. Hypothesis: FV-guided surgery will spare normal tissue at the same time     improving capture of high-risk tissue.   "
243220|NCT01039311|"     Optical coherence tomography will be a feasible adjunct to flexible bronchoscopy, and provide     images with good sensitivity and specificity to determine the presence of endobronchial     malignancies.   "
243261|NCT01039844|"     The goal of this clinical research study is to find the highest tolerable dose of     LOC-paclitaxel when given to patients with metastatic melanoma. The safety of this drug and     if it can control the disease is also being studied.   "
243221|NCT01039324|"     The purpose of this study is to improve patient care and safety while decreasing ED visit     rates by sending specific information about care transitions related to hospital admission     and discharge and emergency department and specialty care visits to primary care practices,     care managers and patients with the use of health information technology (HIT) shared across     a community-based network of providers.      Cycle 1 focuses on the impact of notices about ED encounters and hospitalizations derived     from billing data that are sent to care managers for all 47,000 patients in the Northern     Piedmont Community Care Network (NPCCN). Cycle 2 explores the impact of letters sent to     patients, and care event reports sent to a patient's medical home in addition to notices sent     to care managers about ED encounters, hospitalization and specialty care based on ADT     (Admission Discharge Transfer) and billing data on 4,600 patients with complex health needs.   "
243222|NCT01039337|"     The purpose of the study is to evaluate the effect of manual treatment and a patient     education programme for patients without indication for hip surgery.   "
243223|NCT01039350|"     This is an open-label, single-arm, multicentre, prospective study of darbepoetin alfa to     treat anaemia in patients with low and intermediate-1 IPSS risk MDS. The study will consist     of a 14-day screening period followed by a maximum 24-week treatment period and a final     visit.   "
243224|NCT01039363|"     The prognosis of elderly patients with relapsed or refractory acute myeloid leukemia (AML) is     grave. Because of their chronological age and/or the presence of multiple co-morbidities,     treatment-related mortality in elderly patients with AML is quite high although higher     intensive treatment is mandatory to overcome chemoresistant characteristic of their disease.     Several regimens have been evaluated as salvage chemotherapy for relapsed or refractory AML     such as Mitoxantrone/High dose Cytarabine or Amsacrine/High dose Cytarabine. These regimens     could achieve complete remission (CR) in a part of patients, but resulted in higher treatment     related mortality (TRM). Accordingly, less intensive salvage regimen is needed for elderly     patients with relapsed or refractory AML.      The activity of histone deacetylase (HDAC) inhibitor, Vorinostat or Suberoylanilide     hydroxamic acid (SAHA), against AML has been suggested in cell line models and in animal     model as well as in a phase 1 trial. The phase 1 study determined the MTD of oral Vorinostat     as 200mg twice daily or 250mg thrice daily. In addition, the phase 1 trial showed the     antitumor activity of Vorinostat with 17% of response rate in patients with advanced leukemia     or myelodysplastic syndrome (MDS). Accordingly, further study is recommended to demonstrate     the clinical activity of Vorinostat in AML.      In terms of the combining drug with Vorinostat, anthracycline is one of the best candidate. A     in vitro study demonstrated that the combination of anthracycline (esp. idarubicin) with HDAC     inhibitor have significant clinical activity against leukemia. Another candidate is     Gemtuzumab ozogamicin, which is a calicheamicin-conjugated antibody directed against CD33     antigen on AML blasts. The U.S. FDA also approved the use of GO in relapsed AML as a     monotherapy. A study also showed that the combinational therapy of GO with attenuated doses     of standard induction chemotherapy could successfully induce CR without increasing     treatment-related mortality in AML patients aged 55 or older. A in vitro study reported that     HDAC inhibitor valproic acid augmented the clinical activity of GO toward CD33+ AML cells.     The study demonstrated that the strategy using HDAC inhibitor together with GO could     potentially induce synergistic proapoptotic activity against AML blasts without increasing     toxicity. In our center, so far we treated relapsed or refractory AML patients using the     salvage regimen including GO (3mg/m2/dayx1day) plus attenuated Idarubicin/Cytarabine     (Idarubicin 12mg/m2/day for 2 days and intermediate dose Cytarabine). So far, the CR rate     from the regimen is around 50% without increasing TRM. Accordingly, we will determine the     efficacy and toxicity of Vorinostat-incorporating salvage regimen based on the GO+IA     chemotherapy in patients 50 years old or older with relapsed or refractory AML.   "
243225|NCT01039376|"     The purpose of this study is to determine if maintenance therapy with ofatumumab will prolong     remission in patients with CLL who have responded to second or third line treatment. This     study will also evaluate the safety of ofatumumab maintenance compared to observation (the     current standard of care). This study was co-developed with the HOVON and NORDIC CLL group     and will be conducted as a collaborative effort with GSK.   "
243226|NCT01039389|"     The purpose of this study in patients with chronic stable coronary artery disease treatable     by percutaneous coronary intervention (PCI) is to evaluate the long-term efficacy and safety     of the orally taken selective I(f)-inhibitor Ivabradine (Procoralan®, Servier Switzerland)     with regard to the promotion of collateral growth.   "
243227|NCT01039402|"     The purpose of this study is to evaluate connection between GP's estimation of cardiovascular     risk and theoretical calculation.   "
243228|NCT01039415|"     The purpose of the study is to determine why and how marijuana users stop or reduce their     marijuana use.   "
243229|NCT01039428|"     This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum,     when given three times a day for 3 weeks to the hemodialysis (HD) patients with     hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium     carbonate or sevelamer hydrogen chloride.   "
243230|NCT01039441|"     This prospective, randomized controlled trial was designed to compare the efficacy of a     simple maneuver using lower airway pressure (30 cm H2O) and intraperitoneal instillation of     bupivacaine, alone or in combination, to reduce shoulder pain after gynecologic laparoscopy.      Patient aged 15-65 years, scheduled for laparoscopic surgery for benign adnexa disease will     be eligible for the study. Patients will be excluded from analysis if the procedure requires     conversion to a laparotomy, an operative time > 3 hours, or interpretation of pain is     impossible due to serious adverse effects      240 patients will be randomly assigned to one of four groups Upon completion of surgery, the     patient is placed in the Trendelenburg position (30 degrees), and one of four procedures is     followed. For group A (control), 50 ml of normal saline is instilled under the diaphragm and     CO2 is removed by manual deflation of the abdominal cavity through the cannula; For group B,     a mixture of 50ml solution (20ml of 0.5% bupivacaine + 30ml normal saline) is instilled under     the diaphragm and CO2 is removed by manual deflation of the abdominal cavity through the     cannula; For group C, 50 ml of normal saline is instilled under diaphragm and CO2 was removed     by means of a pulmonary recruitment maneuver consisting of five manual inflations of the lung     with a maximum pressure of 30 cm H2O. The anesthesiologist holds the fifth positive pressure     inflation for approximately 5 seconds. During these maneuvers, the surgeon will be instructed     to ensure that the trocar sleeve valve is fully open to allow the CO2 gas to escape. For     group D, patients receive an instillation of a mixture of 50ml solution in combination with     the clinical maneuver.      Patients will be given a questionnaire with the pain question represented as a visual analog     scale (VAS) preoperatively. Patients will be asked to fill out the questionnaires during the     first 24 hours after surgery to determine the frequency and severity of their shoulder pain.     All patients are instructed to record the pain scores regarding their shoulder pain only. The     degree of postoperative shoulder pain will be assessed using VAS at 1, 6, 12, and 24 hours     postoperatively. The VAS, with scores ranging from 0 (no pain) to 10 (excruciating pain), is     constructed without numeration, thus allowing patients to mark a point along the scale that     best represented their pain at that time.      In addition, the following parameters are recorded on the case report form by the     investigators: operative time, blood loss, the length of hospital stay, analgesic use, and     incidence of postoperative events.   "
243231|NCT01039454|"     This novel compound is a new experimental treatment that may help people to stop compulsive     overeating. Compulsive overeating or binge eating is one of the main reasons why people are     overweight or obese. Recent research has shown that some kinds of overeating may be linked to     a brain chemical called dopamine. There is some evidence that blocking the action of this     chemical in animals can reduce food intake, particularly of foods that are high in fat and     sugar. The purpose of this study is to find out if this compound (which blocks the effects of     dopamine) has the same effect in overweight or obese people, as it does in animals.   "
243305|NCT01040416|"     The objective of this study is to identify the incidence rate; describe the risk factors,     clinical presentation, and endoscopic treatment; assess the morbidity, mortality, and overall     performance of the management of patients with actively bleeding marginal ulcers after     Roux-en-Y gastric bypass (RYGB) surgery.   "
243233|NCT01039480|"     Resistance to antiplatelet drugs (aspirin, clopidogrel) is a recognized phenomenon with a     prevalence from 17% to 35%. Resistance as detected by in vitro tests such as Multiple     Electrode Aggregometry (MEA) has been shown to predict clinical therapy failure. Resistance     can be caused by clinical, cellular and pharmacogenetic factors. Non compliance is suspected     to be an important contributing factor. In this study, compliance will be assured with an     electronical compliance monitoring system. Factors to non response will be identified to find     plausible explanations when in vitro platelet aggregation inhibition is insufficient despite     assured compliance. This study will help to disclose the relationship between compliance,     biomarker and clinical outcome as well as to quantify the impact of non compliance to the     resistance phenomenon as measured by MEA.   "
243234|NCT01039493|"     The objective of this study is to establish patient preferences in regards to common     complications of cervical cancer treatments, and to compare these preferences to those of     medical providers who care for cervical cancer patients. These preferences will be determined     via a interview using the Standard Gamble, which is a well-recognized method for establishing     utilities.   "
243235|NCT01039506|"     The purpose of this study is to examine the correlation between UGT1A1 genotypes and the     efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic     colorectal cancer.   "
243236|NCT01039519|"     The purpose of this study is to determine if STA-9090 is effective in the treatment of     patients with metastatic and/or unresectable GIST.   "
243237|NCT01039532|"     It is a proven fact that Basal Bolus insulin regimen is the near- physiological regimen &     Thrice daily Biphasic Insulin Aspart is a comparable alternative for glycemic control in type     2 diabetes mellitus patients. In this study the investigators evaluated whether Biphasic     Human Insulin can be used in a thrice daily regimen in place of BIAsp.      As the regimen is less expensive and one prick less than the basal-bolus regimen, it can be a     good alternative for a diabetics in India.      This is a 12 week Open labelled parallel-Randomised controlled pilot study - 50 patients with     type 2 Diabetes mellitus was selected after satisfying the inclusion and exclusion criteria's     .Metformin and pioglitazone were continued and they are randomised into 2 groups at base line     and was allotted into any of the two regimens.        1. Basal detemir + bolus aspart or        2. Thrice Daily Biphasic Human Insulin Regimen.      The two regimens were compared by the following variables:      Primary endpoint:      Glycaemic control      Secondary endpoint:      Weight gain, Hypoglycaemic episodes, Adverse effects and Cost effectiveness   "
243238|NCT01039545|"     We propose to perform a randomized controlled patient and assessor blind trial in women     between the ages of 18 to 70 years with acute uncomplicated UTI to evaluate initial     symptomatic treatment for 3 days with the non-steroidal anti-inflammatory drug diclofenac     (experimental intervention) against immediate antibiotic treatment with norfloxacin for 3     days (control intervention). Both interventions are followed by optional delayed antibiotic     treatment with single dose fosfomycin if deemed necessary by the patients. The primary     objective is to determine whether initial symptomatic treatment followed by optional delayed     antibiotic treatment (experimental intervention) is non-inferior to immediate antibiotic     treatment (control intervention) in terms of symptom resolution.   "
243239|NCT01039558|"     We will estimate the responses of lansoprazole and ecabet sodium combination therapy and     compare with lansoprazole and placebo therapy in patients who need additional therapy after     standard proton pump inhibitor treatment for 4week or more in recurrent gastroesophageal     reflux disease.   "
243240|NCT01039571|"     The purpose of this study is to determine whether double row repair is better in healing than     traditional single row repair in arthroscopic rotator cuff repair.      Our null hypothesis is there are no differences in clinical and structural results   "
243241|NCT01039584|"     This was a study that compared the efficacy and safety of a generic butoconazole nitrate     vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of     vulvovaginal candidiasis caused by Candida species.   "
243242|NCT01039597|"     A clinical trial is being conducted to test the effects of a potential new treatment in     patients with ulcerative colitis. Study participants will be given capsules containing either     ORE1001 or a matching placebo capsule and will take the medicine by mouth for six weeks.     Study participants will be asked to visit clinic sites where they will be asked questions     about their ulcerative colitis. Small samples of blood will be be drawn at study visits to     monitor the participant's health and a tiny sample of tissue will be taken in an endoscopy at     two times to determine whether the disease is getting better or worse.   "
243243|NCT01039610|"     GSK945237 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of     antibiotics. GSK945237 has demonstrated in vitro and in vivo activity against Gram positive     [including methicillin resistant Staphylococcus aureus (MRSA)] and Gram-negative pathogens     associated with respiratory tract, skin and soft tissue infections including isolates     resistant to existing classes of antimicrobials. This study will be conducted in four (4)     parts, with a single oral dose being explored in Part A (2400 mg) and repeat oral doses     (b.i.d. and q.d.) being explored in Part B. Parts C and D will be optional evaluations of     repeat oral doses of linezolid and a comparative evaluation of the effect of GSK945237 and     moxifloxacin, respectively. Parts A and B will be single-blind, randomized,     placebo-controlled, dose-rising (Part B only) studies of healthy subjects to evaluate the     safety, tolerability and pharmacokinetics of GSK945237. The proposed doses range from 400 mg     to 2400 mg. Part C will be a single-blind, randomized, and placebo-controlled repeat dose     evaluation of 600 mg (b.i.d.) of linezolid. Part D will be a single-blind, randomized,     placebo-controlled, two period crossover study. The proposed doses for Part D will be 1200 mg     GSK945237 and 400 mg moxifloxacin.   "
243244|NCT01039623|"     Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive     the adjuvant vaccine while the other group will get intradermal antigen, without the     adjuvant. The antibody production will be compared.   "
243262|NCT01039857|"     This is an intervention study with patients after a non-progressive brain injury who suffer     from depression. It will determine whether an integration of neuropsychological and     psychotherapeutic techniques and an additional caregivers support program offers benefits to     those in the process of coping with the effects of a stroke. The investigators expect the     integrative neuro-psychotherapy to be more effective in the treatment of emotional distress     reactions following a stroke than the structured solution focused treatment.   "
243245|NCT01039636|"     The purpose of this research study is to study the safety of increasing doses of FBS0701, and     to see how quickly the study medication is absorbed and how quickly it disappears from the     bloodstream. FBS0701 is a new, oral iron chelator - a medication taken by mouth that     increases the body's elimination of iron. Iron chelators are used in patients who develop     iron overload from their transfusions. Four increasing doses of FBS0701 will be tested during     this study. The study will start with the lowest dose given to 4 patients (3 mg/kg/day. The     next group of 4 patients will receive the next high dose (8mg/kg/day only after the results     of the first 4 patients are examined and it is determined safe to continue. Participating     patients will take the study medication for 7 days and be followed for 28 days after their     last dose to determine if they have any reactions to the study medication - therefore a total     of 35 days on study. Patients will need to give up to 17 blood samples over the screening     period and first 15 days of the study (a total of about 9 tablespoons). Patients will not     need to stay overnight in the clinic but will need to visit the clinic 10 times for screening     and on-study visits over the 35 days. Patients currently taking an iron chelator will need to     stop that treatment for up to 22 days (up to 5 days before they start the study and for 15     days during the study). The results of this study will be helpful in determining the safety     of the drug and the best doses of FBS0701 to be used in the next study which will assess the     effectiveness of this new iron chelator.   "
243246|NCT01039649|"     It is known that radiation damages lung tissue. New human studies at University of Iowa show     that the radiation damage is not as expected. The purpose of this study is to document lung     function using four-dimensional computed tomography (CT) and quantify changes three months     after radiation therapy for malignant lung disease.   "
243247|NCT01039662|"     This study aims to investigate the effect of supplement containing L-arabinose and     indigestible dextrin on dietary glycemic index.   "
243248|NCT01039675|"     The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the     combination of inhaled GSK573719 and GW64244 compared to placebo, in subjects with COPD.   "
243249|NCT01039688|"     This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to     methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This     study will also compare the safety of CP-690,550 with methotrexate.   "
243250|NCT01039701|"     The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs     Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to     moderate Alzheimer's disease.   "
243251|NCT01039714|"     Hypocalcemia is one of the most frequent complications of total thyroidectomy, a procedure     used for benign as well as malignant conditions of the thyroid gland. Postoperative     hypocalcemia is usually caused by hypoparathyroidism. Vitamin D is implicated in calcium     metabolism as it increases intestinal calcium transport and regulates parathormone     production. Aim of the present study is to evaluate preoperative vitamin D levels as a     prognostic factor for postoperative hypocalcemia and hypoparathyroidism.   "
243252|NCT01039727|"     The first objective of this thesis is to investigate the hypothesis that prerecorded     autosuggestion (PA) can be a theoretically valuable (efficacy) and practical (efficiency)     tool in the care of many patients with chronic pain. With a prevalence in chronic pain     conditions of +/- 20% of adults, chronic pain is a huge problem for individuals as well as     for society, absorbing an enormous amount of resources. Even with all available treatments,     many people still suffer from chronic pain, in particular when this pain has a psychosomatic     ('functional') origin. In the PALPI study (Prerecorded Autosuggestion in Long-standing Pain     Intervention), accompanying this thesis, efforts are made to mainly involve chronic pain of     clearly psychosomatic origin.   "
243253|NCT01039740|"     The purpose of this study is to determine whether pharmacogenetic study predict Mirtazapine     responsiveness in advance before the appearance of the drug effect until 4-6 weeks after     administration of Mirtazapine.   "
243254|NCT01039753|"     Acute kidney injury is more frequent and the mortality rate would be as high as 50-60% when     the renal replacement therapy was needed. Many studies about the timing of start and     discontinuation of dialysis, dialysis dose, dialyzer, anticoagulation and dialysates were     initiated but the results were still controversial. In addition, more new biomarkers were     found to predict the outcome of acute kidney injury and these biomarkers may play an     important role for the dilemma of aforementioned studies.      This observational prospective study has two objectives:        1. To find the predictors of outcome for the acute kidney injury with renal replacement          therapy and determine the appropriate method.        2. To find the relationship between new biomarkers and acute kidney injury and determine          whether it can be a factor for the monitor of the response of the renal replacement          therapy.   "
243255|NCT01039766|"     This study is designed to test the hypothesis that a single administration of intranasal     oxytocin within 6 hours post-trauma facilitates the physiological recovery for the trauma,     thereby preventing the development of Post Traumatic Stress Disorder (PTSD) in the months     following the event. In the absence of such treatment (i.e., under placebo conditions), we     hypothesize that a greater proportion of persons will develop PTSD (i.e., fail to recover     from acute effects).   "
243256|NCT01039779|"     The effects of tai chi exercise and lower-extremity training on improving the primary outcome     and secondary outcomes among older people will be compared.   "
243257|NCT01039792|"     The purpose of this study is to determine whether the supplement Methyl B12 is effective in     treating some of the symptoms of Autism.   "
243258|NCT01039805|"     The aims of MOT112571 are to assess the pharmacodynamic effects, safety, tolerability,     pharmacokinetics, and potential therapeutic benefit of single doses of GSK962040 in     critically ill patients with delayed gastric emptying and who are intolerant to enteral     feeding.   "
243259|NCT01039818|"     The purpose of this study is to determine whether higher doses of radioiodine increase     treatment efficacy in severe Graves' disease.   "
243260|NCT01039831|"     The relationship between WM lesions (WM) and Postural Instability Gait Disorders (PIGD-PD)in     Parkinson's disease patients is largely unknown. We hypothesize that sub-clinical WM     pathology may be a major contributing factor to PIGD-PD. We will compare two groups of     patients with Parkinson's disease (PD): those with PIGD and patients with dominant tremor     (n=120)to assess the role of brain WM changes.   "
243266|NCT01039909|"     The main purpose of this study is to investigate the effect of SRT2104 upon energy production     in muscle (specifically the maximum amount of energy produced with muscle contraction), how     much sugar and fat are stored in the muscle, and the size of the muscle after receiving 2.0 g     of SRT2104 or placebo given in capsule form once a day for 28 days including a 14 day knee     and lower leg immobilisation period during the final 14 days of dosing.      Imaging methods, muscle biopsies and exercise tests will be used in the study to see whether     the following measurements change after taking SRT2104 for 28 days, including an immobilised     knee and lower leg for the final 14 days of dosing.      i) energy reaching the muscles ii) muscle strength iii) changes in the structure of the     muscle      This study will also investigate the pharmacokinetics, safety and tolerability of 2.0 g of     SRT2104 administered orally once daily for 28 consecutive days. The investigation of     pharmacokinetics of SRT2104 allows us to gather information regarding:      i) how long it takes for the drug to be absorbed and detected in the blood ii) how much we     can detect iii) how long we can detect it for iv) how often we need to give the drug to     maintain a steady amount in the blood.      SRT2104 will be given to healthy subjects aged between 18 and 40 years old. Subjects will     participate in this single centre study for approximately 79 days. The study consists of 11     outpatient clinic visits and 4 telephone calls (including a prescreen call to determine     whether subjects are interested in participating).   "
243267|NCT01039922|"     Gastroentero-pancreatic neuroendocrine tumours (GEP-NETs) are regarded as a fairly rare     disease. They are derived from the neuroendocrine system of the gastrointestinal tract and     the pancreas and share common clinical features. So far, there is still uncertainty about the     cell biology and mechanistic regulation of these tumours. Therefore targeted treatment is     limited and management challenging. Treatment options include surgery, medical and ablative     therapy, and more recently peptide-receptor radionuclide therapy. In order to better     understand the characteristics of GEP-NETs and to evaluate treatment strategies, the SwissNET     registry aims at the collection of data from patients presenting with a GEP-NET in     Switzerland. Data will be entered prospectively and anonymized in a specifically designed     database after the patient has given informed consent. All hospitals and general     practitioners are invited to report on patients with a GEP-NET diagnosis and to participate     to the registry. Data will be evaluated within regular time frames, focussing on types of     GEP-NETs, treatment modalities and patient outcomes (e.g. mortality, hospitalisation rate),     thereby contributing to the better understanding of these tumours.   "
243268|NCT01039935|"     Prior to the main study we will perform a pilot study on 60 subjects. The purpose of the     pilot study is to identify the range of odor concentrations that will be used in the main     study and to optimize the tasks performed in the main study.   "
243269|NCT01039948|"     During Phase 1b portion, there will be a dose-escalation of AV-299 (formerly SCH 900105) in     combination with the recommended dose of gefitinib in subjects with NSCLC or advanced solid     tumor. The objective is to determine the safety, tolerability, dose limiting toxicity (DLT)     and recommended Phase 2 dose (RP2D) in combination with gefitinib for the Phase 2 portion.      The Phase 2 is an open-label, 2-arm, randomized study designed to compare the combination of     AV-299 (formerly SCH900105) and gefitinib versus gefitinib alone in clinically selected Asian     subjects with previously untreated lung adenocarcinoma who have a high likelihood of     harboring activating EGFR mutations. Subjects who progress after initial disease control in     the gefitinib alone arm may crossover to the combination arm.   "
243270|NCT01039961|"     The purpose of this study is to evaluate the safety of an IV infusion of GW856553 in healthy     volunteers.   "
243271|NCT01039974|"     This study will determine the effect of 400 mg ketoconazole on the pharmacokinetics of a     single dose of GSK962040. The results from this study will help to estimate the maximum     increase in exposure during concomitant use of strong CYP3A4 inhibitors. This study will also     contain an exploratory investigation of biliary secretion of GSK962040 and or its     metabolites.   "
243272|NCT01039987|"     The Division of Kidney Urology and Hematology Disease (DKUHD) of the National Institute of     Diabetes and Digestive and Kidney Diseases (NIDDK) funded a cooperative agreement (UO1) for a     consortium of participating clinical centers (PCCs) and a data coordinating and imaging     analysis center (DCIAC) to develop and implement studies to test whether imaging techniques     can provide accurate and reproducible markers of progression of renal disease in patients     with polycystic kidney disease.      The awarded participating clinical centers are Emory University, University of Kansas, and     Mayo Foundation (with a subcontract to the University of Alabama). The awarded DCIAC is     Washington University in St. Louis. Due to the relocation of the DCIAC P.I. from Washington     University to the University of Pittsburgh, the DCIAC for CRISP II is located at the     University of Pittsburgh.   "
243273|NCT01040000|"     The purpose of the phase 2 component of this study is to determine if giving the immune     molecule NPC-1C to individuals who have cancer of the pancreas or gastrointestinal tract     (colon or rectum) which has not responded to standard treatments can shrink or halt the     growth of cancer, and to obtain additional data to study its effect on the immune system.     Safety data will also be accumulated and evaluated during this study. NPC-1C is a monoclonal     antibody that recognizes a specific tumor target on certain cancers. In laboratory studies,     the antibody killed tumor cells in some colon and pancreatic cancers that express the NPC-1C     antigen by a process called antibody-dependent cell cytotoxicity or ADCC.   "
243274|NCT01040013|"     Patients with left-colon cancer will be randomized to laparoscopic or laparotomic operation.     during surgery and for 6 days after operation, intestinal oxygen tension and     ischemia-reperfusion injury markers will be evaluated to understand if pneumoperitoneum is     associated with reduced splanchnic blood flow and ischemia-reperfusion injury.   "
243303|NCT01040390|"     Acne is one of the most common skin problems in teenagers and adolescents. There are many     lesser known homoeopathic medicines which have been mentioned in the literature for treatment     of acne but their potential has not been properly assessed /documented and therefore these     medicines don't form a part of many prescriptions. As a part of this study,efficacy of Lappa     Arctium will be studied in the treatment of Acne vulgaris   "
243304|NCT01040403|"     The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL     and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week     treatment in patients with COPD.   "
243275|NCT01040026|"     High-dose chemotherapy with melphalan and autologous hematopoietic stem cell transplantation     (HSCT) is considered standard treatment for patients with multiple myeloma. While autologous     HSCT may induce remission in patients resistant to standard chemotherapy, and has been shown     to lead to long-lasting disease control in a subgroup of patients, the procedure is not     curative. Given enough time and in the absence of a competing cause of death, all patients     eventually relapse after auto-HSCT.      The only potentially curative approach currently available in the treatment of multiple     myeloma (MM) is stem cell trans-plantation from an allogeneic donor. Allogeneic HSCT     eradicates residual myeloma cells through T-cell mediated graft-versus-tumor effects.     Allogeneic HSCT is, however, associated with significant risk of graft-versus-host disease     and its use is therefore limited to younger patients with high risk dis-ease. Malignant     plasma cells in multiple myeloma are also sensitive to natural killer cell lysis. Natural     killer cells do not cause graft-versus-host disease, which has led to interest in their     therapeutic use in patients with multiple myeloma.      We have previously shown that immunomagnetic separation of a highly pure NK cell product from     a leukapheresis is possible and that these cells can be expanded up to 100-fold in a     GMP-compatible setting. The current study aims to test the tolerability and feasibility of     infusions of in vitro expanded haploidentical NK cells for patients after melphalan 200mg/m2     high dose chemotherapy and autologous HSCT in 10 patients. If feasible, the data will provide     a basis for further prospective studies.   "
243276|NCT01040039|"     This pilot study aims to study gut B cells in HCV+HIV+, HCV+HIV-, HCV-HIV+, and HCV-HIV-     volunteers. Volunteers will undergo a screening blood draw and flexible sigmoidoscopy with     biopsy.   "
243277|NCT01040052|"     The objective of this study is to describe the safety of Adacel® vaccination in adults     subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in     support to Adacel® registration.      Primary objective:      To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after     immunization.   "
243278|NCT01040065|"     The purpose of this study is to determine whether distal clavicle resection is effective     treatments in patients with acromioclavicular joint pain accompanied by rotator cuff tear.   "
243279|NCT01040078|"     The purpose of this study is to generate data on immunogenicity and safety of the monovalent     H1N1 vaccine in support of the development and registration.   "
243280|NCT01040091|"     Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are two antiretroviral     medications used for the treatment and prevention of HIV/AIDS. This study will examine how     these medications are processed in the body of people who are HIV-infected, as well as in     people who are HIV-uninfected.   "
243281|NCT01040104|"     Regular wound healing follows a well-ordered sequence of overlapping phases: inflammation,     proliferation, maturation and remodelling.      In the young, damage to an organ mostly triggers fully regenerative mechanisms called     primary wound healing. Repeated damage in young individuals may cause secondary wound     healing eg. scar formation reflecting a rescue program, in which reorganisation has failed.      Organ failure in the ageing organism is characterized by a progressive loss of its capability     to achieve an orderly reactivation of organ repair, and results in a combination of chronic     inflammation and fibroproliferative, non-regenerative repair affecting several organs,     including lung, liver and skin.      RESOLVE's objective is to identify, characterize, and validate molecular targets responsible     for shifting primary organ repair towards fibroproliferative wound healing as a result of an     age-dependent loss of regulatory control.      The structured approach is based on        -  different forms of wound healing,        -  different human diseases and        -  different genetic backgrounds,      aiming to provide future diagnostic tools in various organs, to create transgenic animal test     systems, and to identify molecular targets involved in fibroproliferative wound healing.   "
243282|NCT01040117|"     Balance impairment is a common and very disabling disturbance in people with Multiple     Sclerosis. The efficacy of pharmacotherapy in treating balance impairment in MS is poorly     documented in literature. Although literature dealing with the rehabilitation of balance     impairment in MS is very scant, the preliminary data reports show very promising results. The     present project could have a positive impact on balance and gait ability, disability, fear of     falling, risk of falls and quality of life of patients with Multiple Sclerosis.   "
243283|NCT01040130|"     To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of     treatment in patients with Chronic Obstructive Pulmonary Disease   "
243284|NCT01040143|"     A study taking swabs from the back of the nose (nasopharynx) to look at carriage of     pneumococci.   "
243285|NCT01040156|"     Pediatric patients are at high risk to acquire mycotic infections following allogeneic bone     marrow transplantation. In the present retrospective analysis we assess the safety and     efficacy of different regimens in antimycotic prophylaxis.   "
243286|NCT01040169|"     Tooth sensitivity reduction after dentifrices use   "
243287|NCT01040182|"     The purpose of this study is to explore the association between the genetic polymorphisms of     estrogen-related genes, including estrogen synthesis, metabolizing, and receptor genes, and     ischemic stroke. Furthermore, independent and joint effects of traditional risk factors and     estrogen related genes on risk of stroke in young adults will also be examined in this study.   "
243299|NCT01040338|"     A substantial body of evidence implicates the endogenous opioid system, and the mu opioid     receptor (MOR) in particular, in the reinforcing effects of drugs of abuse, including     nicotine. A single nucleotide polymorphism (SNP) in the mu opioid receptor gene (OPRM1 Asp40)     is associated with the ability to quit smoking, as well as nicotine reward and withdrawal     symptoms. However, the precise mechanism through which this SNP influences nicotine     dependence remains unresolved. This positron emission tomography (PET) study will examine     whether this OPRM1 SNP alters MOR binding in response to nicotine in human smokers.     Specifically, we will use [11 C]carfentanil PET imaging to assess the effects of intravenous     (IV) nicotine versus saline (within-subject) on MOR binding potential in 24 chronic smokers     genotyped prospectively and stratified by OPRM1 genotype.   "
243300|NCT01040351|"     The aim of this study is to determine whether the ultrasound guided aspiration of     hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .   "
243288|NCT01040195|"     Till now no drug has been conclusively shown to affect the natural course of the inflammatory     back ache in seronegative spondylarthropathies. Non-steroidal anti-inflammatory drugs     (NSAIDS) have been the main stay of treatment for these diseases for long. Despite providing     good pain relief, they are largely ineffective in altering the natural course of these     diseases. However, very often, in spite of therapy, pain and discomfort continues in these     patients with recurrent exacerbations. Other drugs have been tried in these patients.      The DMARDS (Disease Modifying Anti Rheumatic Drugs) are a group of drugs which have come into     prominence following their remarkable efficacy in the management of Rheumatoid Arthritis,     another chronic inflammatory autoimmune arthritis. The major drugs which come in this group     are Methotrexate, Sulfasalazine, Hydroxychloroquine and Leflunomide. Of these drugs, the most     well studied drug in Spondylarthropathy is Sulfasalazine. Trials have shown variable results     of response of spondyloarthropathy to sulfasalazine. The other major DMARD tried is     methotrexate. Though large well controlled trials are lacking, the available data on its     efficacy in spondyloarthropathy has not been favorable. Leflunomide, the other major DMARD     has also fared poorly in a controlled trial in ankylosing spondylitis. There is at present     inadequate data regarding the efficacy of Hydroxychloroquine.      The discovery of anti TNF-α have been the major breakthrough in the management of ankylosing     spondylitis (AS) and Spondyloarthropathies (SpA). These drugs, besides providing symptomatic     improvement, also produce improvement in the indices of disease activity as Bath Ankylosing     Spondylitis Disease Activity Index (BASDAI) and the Assessment of Spondylo-Arthritis     International Society (ASAS). Besides, the enormous cost, incurred at a rate of about Rs     700,000/- per annum, put it out of reach of the majority of affected population. Add to these     is the increased risk of tuberculosis and fungal infections, a major problem in India.      In this background there is severe and pressing need for alternate safe and effective drugs     in the management of these diseases. It is here that the combination DMARD therapy assumes     importance as a potential safe and cheaper alternative.      We aim to assess the efficacy of combination DMARD therapy in patients with early     inflammatory chronic backache in patients with sero negative spondyloarthropathies.   "
243289|NCT01040208|"     The current trial will explore the safety of flibanserin in combination with Selective     Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a     representative population of women with depressive and possible concurrent anxiety     symptomatology.   "
243290|NCT01040221|"     The purpose of this study is to determine whether Trichuris Suis Ova (TSO) is safe and     effective in treating adults with autism spectrum disorder   "
243291|NCT01040234|"     A prospective study of 30 patients with severe postoperative pain following abdominal     surgery, in which the dual TAP block technique has been used successfully to achieve pain     relief. A description of ultrasound technique, effectiveness, duration and potential side     effects of the pain treatment, with possible recommendations for future use.   "
243292|NCT01040247|"     Women undergoing in vitro fertilization (IVF) therapy, who are low responder and agree to     enter the trial will be randomized to a study group, for whom embryo transfer will be done on     the same day as oocyte aspiration and fertilization; and a control group for whom embryo     transfer will be performed 48 to 72 hours later, as is the current accepted practice.   "
243293|NCT01040260|"     An innovative low-cost form of contingency management has been developed in which     participants receive the chance to draw vouchers from a fish bowl depending on whether or not     their abstinence from tobacco is confirmed by expired-air carbon monoxide. The vouchers can     be redeemed for prizes of varying value. This form of contingency management has been shown     to be effective in the treatment of a variety of substance use disorders, but has not been     investigated in a clinical trial focusing on smoking cessation. Thus, the primary purpose of     the proposed study will be to investigate the effects of a low-cost prize-based form of     contingency management in the treatment of nicotine dependence. To accomplish this objective,     we enrolled 103 current smokers into the study. The participants in Study Arm 1 received the     contingency management intervention for 8 weeks, and the participants in Study Arm 2 had     their smoking status assessed but did not receive the contingency management intervention.     Both interventions received brief counseling and nicotine replacement therapy. The counseling     was conducted in two 60-minute individual sessions scheduled one week apart with two     follow-up phone calls at weeks 3, 4, and 6.      The primary outcome for this study was biochemically-validated smoking status at 3 months     (end of treatment), and at 6- and 12-month follow-up. Both continuous and point-prevalent     abstinence rates were determined. Saliva cotinine levels were measured in all participants     reporting abstinence at each assessment. This study had 80% power to detect a 10% absolute     difference in smoking cessation rates between the two treatment conditions (i.e., a 28% quit     rate in Study Arm 1 versus a 18% quit rate in Study Arm 2) with alpha set at 0.05. These     estimates included an anticipated 15% loss to follow-up over the 12-month study period.   "
243294|NCT01040273|"     Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage     following major orthopedic surgery often involves a large, deep incision with considerable     tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such     surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay     mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical     costs.      We design a prospective randomized study for postoperative pain control following total hip     arthroplasty.   "
243295|NCT01040286|"     The purpose of the study is to assess efficacy and safety of Flurbiprofen Chip versus     Chlorhexidine chip (Periochip®) in therapy of adult chronic periodontitis.   "
243296|NCT01040299|"     Transcranial galvanic stimulation (tDCS), seems to promote motor recovery after stroke by     stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment     of severe lower limb paresis after stroke, the GangTrainer GT1 (GT) proved to be effective,     but nevertheless only a few patients could use their affect lower limb functionally in daily     life on deambulation after robot training. Therefore the present study intends to combine     both approaches, tDCS + GT, apply at the same time every day for two weeks in order to     improve the effectiveness of GangTrainer therapy in the gait rehabilitation.   "
243297|NCT01040312|"     The purpose of this study is to examine the correlation between UGT1A1 genotypes and the     safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for     patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.   "
243298|NCT01040325|"     The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent     moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.   "
243301|NCT01040364|"     The main goal of this study is to describe the trends in the incidence rate of internal     hernia presentation after different modifications of the mesenteric closure technique after     primary laparoscopic Roux-en-Y gastric bypass (RYGB) surgery from 1997-2009.   "
243302|NCT01040377|"     The main aim of this study is to analyze and report traditional, patient-centered, and     composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass     surgery for inadequate initial weight loss.   "
243308|NCT01040455|"     Pharmacotherapy for functional dyspepsia remains unsatisfactory. Previous randomized trials     reported conflicting results on clinical effectiveness of proton pump inhibitor in patients     with functional dyspepsia. This study aims to examine whether lansoprazole 15mg is more     effective than placebo for functional dyspepsia in Taiwanese patients, and to investigate the     association between subgroups of patients and therapeutic response.   "
243309|NCT01040468|"     This research study will investigate the safety and effectiveness of weight loss surgery for     overweight persons with type 2 diabetes. Eligible patients will undergo one of 2 types of     weight loss surgery, Roux-en-Y gastric bypass, or laparoscopic adjustable gastric banding, or     an intensive lifestyle modification. Participants will be closely followed for one year to     compare the effects of these treatments on diabetes remission.   "
243310|NCT01040481|"     The main aim of this study is to analyze and report the preliminary and intermediate term     outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism.     The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and     expressed as trends in BMI, %EWL, and/or %EBL; 2) Trend in Comorbidity status; and 3) Patient     satisfaction and Health-Related Quality of Life HR-QoL measured by a standardized,     non-validated subjective satisfaction questionnaire and the validated, disease-specific,     Moorehead-Ardelt II QoL questionnaires, respectively; 4) Morbidity & Mortality including     nutritional status and metabolic complications.      Consequently, secondary objectives of this study are 1) to assess failure rate defined as     percentage of excess weight loss < 50% , lowest BMI >35 for morbidly obese (MO) or >40 for     superobese (SO), and/or lack of resolution/improvement of major comorbidities at the point in     time when assessing preliminary and intermediate results after the surgery under analysis. 2)     To evaluate the metabolic and nutritional status by measurements of particular clinical and     biochemical parameters.      This research is in line with the most current provocative new ideas and recent high impact     publications. To the best of our knowledge, this is the very first outcome study of     revisional malabsorptive distal gastric bypass surgery by laparoscopy with diverse revisional     strategies such as revisional gastroplasty, revisional Fobi-Capella, revisional Adjustable     Gastric Band, conversion to distal, and conversion to very, very long limb gastric bypass.     Previously, several studies have addressed conversion to malabsorptive gastric bypass after a     failed primary proximal gastric bypass but none has addressed the failed distal gastric     bypass nor the adequate balance between increasing restriction and malabsorption for     decreasing the risk of protein-calorie malnutrition.   "
243311|NCT01040494|"     Aliskiren is a potent direct renin inhibitor and has been recently shown to have favorable     neurohumoral effects in patients with heart failure (HF) Objective：To study the effects of     add-on aliskiren treatment in patients with HF on components of arterial load, from central     aorta to peripheral arterioles and biomarkers Methods：Patients with NYHA Class II to IV HF,     who have been treated with angiotensin-converting enzyme inhibitor (ACEI) or angiotensin     receptor blocker (ARB) and beta-blocker are randomized to 6 months of treatment with placebo     or aliskiren (150mg per day) treatment. Components of arterial load, from central aorta to     peripheral arterioles as well as a wide-range of biomarkers, including inflammatory     biomarkers, N-terminal pro-B type natriuretic peptide, arterial remodeling markers     (procollagen, matrix metalloproteinase) will be measured before, 2 months and 6 months after     treatment.      What is New or Innovative in this study? The importance of central hemodynamics and biomarker     changes in patients with HF has been shown in observation studies. This is the first     randomized control trial that examines comprehensively the effects of a direct rennin     inhibitor on central hemodynamics and biomarkers in HF patients who are receiving standard     heart failure therapy.   "
243312|NCT01040507|"     The main aim of this study is to analyze and report the very long-term outcomes after primary     laparoscopic proximal Roux-en-Y gastric bypass surgery for clinically severe obesity.   "
243313|NCT01040520|"     The aim of the study is to compare findings generated by CT-based autopsy (Virtopsy) with     conventional autopsy and clinical diagnoses. Therefore all patients dying while receiving     treatment in the Department of Intensive Care Medicine will be undergo virtopsy and, if     relatives give informed consent conventional autopsy.   "
243314|NCT01040533|"     This study objectives are the following.        -  To describe the updated clinical presentation, indications, and multidisciplinary          medical management of patients with a failed and/or complicated jejunoileal bypass          (JIB).        -  To analyze the feasibility, safety, and efficacy of one-stage laparoscopic re-operative          gastric bypass surgery for failed and/or complicated Jejunoileal bypass (JIB) for weight          loss.        -  To determine what factors or strategies are associated with a successful outcome. In          particular, the completion of the surgery in one stage with a laparoscopic approach.   "
243315|NCT01040546|"     The purpose of this study is to assess study subjects' adherence to different weight control     intervention programs and the effect of intervention programs on physical and biochemical     examinations, physical fitness, food intake and exercise behaviors and the prevalence of     metabolic syndrome and its components' abnormalities.   "
243316|NCT01040559|"     The purpose of this study is to determine the maximal tolerated dose of idarubicin for     chemoembolization of non resectable non metastatic hepatocellular carcinoma.   "
243317|NCT01040572|"     The main aim of this study is to analyze and report traditional, patient-centered, and     composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass     surgery for weight recidivism.   "
243318|NCT01040585|"     The therapy with Linezolid (LIN) represents better cost-effectiveness vs. Vancomycin (VAN)     for the treatment of nosocomial Pneumonia associate to ventilator (VAP).   "
243332|NCT01040767|"     Study Objective: Training physicians in new skills via classroom-based teaching has inherent     costs and time constraints. We sought to evaluate whether web-based didactics result in     similar knowledge improvement and retention of basic ultrasound principles and the EFAST     (Extended Focused Assessment with Sonography for Trauma) compared with the traditional     method.      Methods: Physicians from two German emergency departments were randomized into a classroom     group with traditional lectures and a web group that watched narrated lectures online. All     participants completed a pre- and post-test, and a second post-test eight weeks later. Both     groups underwent hands-on training after the first post-test. A control group completed the     two initial tests without didactic intervention.   "
243352|NCT01041027|"     This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in     treating patients with high-risk endometrial cancer. Radiation therapy uses high energy x     rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells, by     stopping them from dividing or by stopping them from spreading. Giving radiation therapy with     chemotherapy may kill more tumor cells.   "
243319|NCT01040598|"     Eosinophilic Esophagitis(EoE) is a condition characterized commonly by vomiting, nausea,     epigastric pain, dysphagia, heartburn and food impaction among other gastrointestinal     symptoms along with obstructive esophageal symptoms in both pediatric and adult population.     The pathology of this disease is postulated to be allergy mediated and the incidence of this     disease is seen to parallel an increase in the incidence of allergies and asthma.      Most of the current therapies for EoE are directed at decreasing esophageal allergic     inflammation and mirror the treatment options for allergic asthma. Swallowed corticosteroids     and elimination diets or elemental diets have shown variable efficacy is improving symptoms.     However, specific pathophysiologic mechanism of EoE is still largely unknown and there is no     definitive treatment that completely resolves symptoms and histological findings. Omalizumab     is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled     and oral corticosteroids and improve asthma related symptoms in patients with allergic     asthma. In this study, Eosinophilic esophagitis is being used as a disease model to study the     mechanism of action of monoclonal Anti-IgE antibody in vivo. The resolution of symptoms     clinically, and histological changes (and improvements) in response to treatment with Xolair     (omalizumab) in patients suffering from EoE will be determined. The primary objective of this     open label, study is to determine mucosal markers that will predict responders to Omalizumab     (Xolair).   "
243320|NCT01040611|"     Tuberculosis belongs to chronic diseases as a result of the treatment of disease over a long     period, admission to negative pressure isolation wards, and restrictions on visitors. During     the in-patient admission, patients are vulnerable to social isolation and separation anxiety.     If anxiety sustained, patients' quality of life would be affected. Thus, it is important to     improve patients' experience of anxiety. Music has the effectiveness of relaxation, and is     helpful to patients' anxious status and physiological responses. This study examined the     effectiveness of music therapy on anxiety, depression and physiological responses for     patients with tuberculosis.   "
243321|NCT01040624|"     The purpose of this study is to see what effects, good and/or bad, proton based radiation     combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.   "
243322|NCT01040637|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).   "
243323|NCT01040650|"     Statins are a class of drugs given to lower cholesterol. Although statins are considered to     be generally safe, some studies show that about 10% of people on statins develop     muscle-related symptoms, from fatigue (tiredness), weakness, cramping, pain and sometimes a     lifethreatening muscle breakdown condition known as rhabdomyolysis. In some, these symptoms     may greatly affect their daily activities. One consideration why symptoms develop in only     some patients is that they may have an underlying problem in the way their muscles use fats     to produce energy. In these patients, the muscles are not able to fully utilize fats and so     they become tired more easily. Fat within the muscle can also affect how your body uses a     hormone called insulin, which affects your blood sugar levels. The investigators are     specifically interested in previous statin users and determine if the muscle symptoms are     related to changes in energy and sugar use. We propose to enroll patients who have developed     muscle side effects on previous statin treatment and have since discontinued statin     treatment.      Our aim is to compare the metabolic parameters in these patients to age and gender-matched     normal individuals.   "
243324|NCT01040663|"     In recent decades, the prevalence of obesity has increased dramatically in the United States.     Obesity has been associated with an increased risk of the metabolic syndrome, which is     characterized by a cluster of metabolic derangements, including insulin resistance, high     blood sugar, high triglycerides, low high density lipoprotein (HDL) cholesterol levels, high     blood pressure, and inflammation. Lifestyle interventions, including dietary modification,     physical activity, and weight loss, form the basis of treatment for individuals with the     metabolic syndrome. However, the optimal composition of the diet is not known at this time.     Furthermore, due to hormonal and metabolic changes that accompany weight loss, most people     find it very difficult to maintain significant weight reductions over time. As a result,     weight regain is exceedingly common.   "
243325|NCT01040676|"     The Automated Telephone Nutrition Support (ATNS) study investigates the effect of automated     telephone nutrition support on diet and glycemic control among Spanish-speaking diabetics in     Oakland.   "
243326|NCT01040689|"     The study is intended to characterize the lung function profile of BI1744 in COPD patients     where patients will perform pulmonary function tests at regular intervals for 24 hours at the     end of a 6 week treatment period. Each patient will receive all four treatments.   "
243327|NCT01040702|"     The aim of the study is to assess the effect of Methylphenidate on cognitive performance and     decision-making ability of ADHD adults, and to compare this effect to the effect on healthy     control adults.   "
243328|NCT01040715|"     The objective of this trial is to demonstrate that active immunization with anti-TNFα kinoid     (TNF-K) is able to induce polyclonal anti-TNFα antibodies in RA patients who were previously     treated with anti-TNFα mAb but have lost susceptibility to therapy.   "
243329|NCT01040728|"     The study is intended to characterize the lung function profile of BI1744 in Chronic     Obstructive Pulmonary Disease (COPD) patients where patients will perform pulmonary function     tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient     will receive all four treatments.   "
243330|NCT01040741|"     This is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted     Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive     either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either     1 or 2 doses.   "
243331|NCT01040754|"     The results of the proposed experiments will directly inform clinicians who treat patients     with osteoarthritis of the knee about how to maximize the benefits of acupuncture treatments.     And because the experiments specifically asks the question of what is the relation between a     patient's expectation of how a treatment will relieve their pain and the outcome of the     treatment, the results will potentially inform care givers about all treatments for     osteoarthritis and other chronic pain disorders. We hypothesize that acupuncture treatment     will produce clinically significant analgesia as indicated by lowered sensory ratings of     noxious stimuli and endogenous knee pain.   "
243336|NCT01040819|"     Type-2 diabetes mellitus is a public health concern. Patients with type 2 diabetes mellitus     are at high risk of developing cardiovascular complications. Diabetic patients are two to     four-times more likely to develope cardiovascular disease. The mortality of diabetic patients     with cardiovascular disease is much higher than in non-diabetic matched patients with     cardiovascular disease. Recently, it has become apparent that not all anti-diabetic drugs     have the same effect on the progression of atherosclerosis and on cardiovascular outcomes.     There is a great need to understand the potential protective mechanisms of the various     anti-diabetic drugs in order to decrease their risk for cardiovascular morbidity and     mortality. In addition to increasing insulin sensitivity, Pioglitazone (PIO) has     anti-inflammatory properties. However, the underlying mechanisms of these anti-inflammatory     (and probably anti-atherosclerotic) effects of PIO are unknown. We have shown in the rat that     3-day pretreatment with PIO increases myocardial cyclooxygenase-2 (COX2) activity and levels     of both 6-keto-PGF1a, the stable metabolite of prostacyclin (PGI2) and 15-epi-lipoxin A4, a     lipid mediator with a strong anti-inflammatory properties. Prostacyclin inhibits platelet     aggregation and causes vasodilatation. Increased levels of 6-keto-PGF1a and 15-epi-lipoxin A4     may thus be the explanation for the anti-inflammatory and anti-atherosclerosis effects of     PIO. Several clinical studies have shown that COX2 inhibition is associated with increased     cardiovascular events. Thus, augmenting COX2 activity and the production of prostacyclin and     15-epi-lipoxin A4 may have potential favorable effects. The purpose of the study is to test     whether PIO therapy is associated with an increase in serum and/or urine levels of     6-keto-PGF1a and 15-epi-lipoxin A4 in patients with diabetes mellitus type 2.   "
243337|NCT01040832|"     The purpose of this study is to determine if EMD 1201081 in combination with cetuximab is     more efficient than cetuximab alone to control the cancer.      EMD 1201081 is an immune modulatory oligonucleotide (IMO) containing phosphorothioate     oligodeoxynucleotide and acts as an agonist of Toll-like receptor 9 (TLR9).      EMD 1201081 has been studied in six clinical trials in over 170 subjects either as a     monotherapy or in combination with chemotherapeutic agents or targeted therapies. Two studies     have been conducted in healthy volunteers. In the other five studies, subjects with advanced     solid tumors, renal cell carcinoma, non-small cell lung cancer and colorectal cancer have     been treated with EMD 1201081. Two studies are still ongoing. Future clinical development of     EMD 1201081 will focus on colorectal cancer (CRC) and squamous cell cancer of the head and     neck (SCCHN).      In this Phase 2 study, subjects with recurrent or metastatic squamous cell cancer of the head     and neck (R/M SCCHN), will be treated with cetuximab plus EMD 1201081 or cetuximab alone. The     study will be conducted as a multicenter study in several European Union (EU) member states     and the Unites States.      EMD 1201081 in combination with cetuximab will be evaluated for antitumor activity in     subjects by examining its effects on accepted clinical endpoints. Progression-free survival     (PFS) will be evaluated in subjects treated with EMD 1201081 plus cetuximab compared to     cetuximab alone in cetuximab-naïve subjects with R/M SCCHN who have progressed on a cytotoxic     therapy.      Cetuximab, approved in colorectal cancer and SCCHN in combination with platinum-based     chemotherapy and SCCHN in combination with radiotherapy in the EU, will be provided as     investigational medicinal product (IMP) in this study. Commercially available Cetuximab will     be provided in the United States.   "
243338|NCT01040845|"     This study will evaluate the effect, if any, of twice daily dosing of colchicine 0.6 mg at     steady state on the steady state pharmacokinetic profile of ethinyl estradiol and     norethindrone (Ortho-Novum 1/35). It will also evaluate the effects, if any, of steady state     ethinyl estradiol and norethindrone on colchicine at steady state. Finally, this study will     assess the safety and tolerability of concurrent use of colchicine and an     estrogen/progesterone-containing oral contraceptive.   "
243339|NCT01040858|"     The number of OEF/OIF veterans seeking care and rehabilitation services within the VA Health     Care System is increasing rapidly. The cognitive effects of MTBI are clinically significant     and can adversely affect a veteran's ability to reintegrate into civilian life, return to     duty, succeed in competitive employment, or function independently. The primary product of     the proposed study would be an empirically validated, manualized, cognitive rehabilitation     intervention for OIF/OIF veterans with cognitive disorders. The group treatment modality has     the virtue of efficiency and a manualized treatment approach would allow wide-ranging     application throughout the VHA system. As such, the proposed study is likely to have a     significant effect on the quality and effectiveness of rehabilitative services being offered     to our returning soldiers with combat-related MTBI and cognitive impairment.   "
243340|NCT01040871|"     This is a randomized, open-label, active-control, parallel-group, multicenter, multinational     Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide,     Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin,     Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center     B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)   "
243341|NCT01040884|"     This will be a prospective, single-arm, single-center, open-label study to evaluate the     preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients     undergoing CT-guided percutaneous aspiration and RF Ablations The procedure will be performed     by a trained physician. Subjects will be screened for inclusion in the study. Following     signing of informed consent, screening procedures will be performed including demographic and     medical history, vital signs, anthropometrics), chest radiography, if applicable and CT     scanning, blood samples for coagulation indices (PT, APTT), if applicable, and pregnancy test     in women of child-bearing potential.      Within an 18-day screening period, eligible subjects will be enrolled into the study and     undergo percutaneous aspiration or percutaneous biopsy or RF ablation utilizing the     ActiSight™ Needle Guidance system using CT to guide the needle. Subjects will be followed-up     for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect     chest radiograph will be performed within 90 minutes of observation after chest aspiration if     performed to detect the majority of post procedure pneumothoraces for biopsies in the chest.     Post procedural CT will be performed according to the physician's consideration. ** Note **     If any complications are observed while using the ActiSight System, the investigator will     revert to using standard procedure.   "
243342|NCT01040897|"     In 2003, Surgeon General Richard Carmona suggested that low health literacy is one of the     largest contributors to our nation's epidemic of overweight and obesity. Over 26% of     preschool children are now overweight or obese, and children who are overweight by age 24     months are five times as likely as non-overweight children to become overweight adolescents.     The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented     intervention aimed at teaching pediatric resident physicians to promote healthy family     lifestyles and prevent overweight among young children (age 0-2) and their families in     under-resourced communities.   "
243351|NCT01041014|"     Numerous studies suggest that the use of in-person, professionally trained medical     interpreters can reduce health care costs associated with diagnosing and treating patients     with limited English proficiency. However, few studies have specifically addressed the     question of the cost-effectiveness of language services in health care settings. This study     used a randomized controlled study design to compare the cost-effectiveness of using     professional interpreters with Spanish-speaking patients seen in hospital emergency     departments (EDs) versus using the usual language services available to these patients. The     main goal of the study was to estimate the effect that professional interpreters have on     resource utilization and patient/provider satisfaction in the ED compared to the language     services usually offered in these settings. Our hypothesis was that use of trained     interpreters would lead to more cost-effective provision of ED services.   "
243343|NCT01040910|"     Background: The marijuana plant Cannabis has been used for centuries in the medicinal     treatment of many disorders and is still the subject of medical research and public debate.     Cannabinoids have been purported to alleviate a variety of neurological conditions such as     MS-related symptoms including spasticity, pain, tremor and bladder dysfunction. Other     neurological conditions like chronic intractable pain, dystonic movement disorders and     Tourette's Syndrome were all reported to be alleviated by cannabis use. Cannabis has been     used to treat anorexia in AIDS and cancer patients. In gastroenterology cannabis has been     used to treat symptoms and diseases including anorexia, emesis, abdominal pain,     gastroenteritis, diarrhoea, intestinal inflammation and diabetic gastroparesis.      Cannabinoids have also a profound anti inflammatory effect, mainly through the CB2 receptor.     Cell mediated immunity may be impaired in chronic marijuana users. And a potent     anti-inflammatory effect of cannabis was observed in rats . Studying the functional roles of     the endocannabinoid system in immune modulation reveals that there are no major immune events     which do not involve the endocannabinoid system. Cannabinoids shift the balance of     pro-inflammatory cytokines and anti-inflammatory cytokines towards the T-helper cell type 2     profiles (Th2 phenotype), and suppress cell-mediated immunity whereas humoral immunity may be     enhanced. They are therefore used for various inflammatory conditions including rheumatoid     arthritis and asthma. In a mouse model of colitis cannabinoids were found to ameliorate     inflammation and there are many anecdotal reports about the effect of cannabis in     inflammatory bowel disease. However, there are no methodical reports of the effect of     cannabis on inflammatory bowel disease. The aim of the proposed study is to examine in a     double blind placebo controlled fashion the effect of smoking cannabis on disease activity in     patients with IBD.   "
243344|NCT01040923|"     The study is designed to evaluate the predictive diagnostic accuracy of SonoMedica's     CardioSond digital electronic stethoscope in the detection of coronary artery disease (CAD)     in patients without known disease who are referred to cardiac computed tomography angiography     (CT scans).   "
243345|NCT01040936|"     PCI has been one of the most common choice of treatments for patients with coronary artery     disease, and studies indicated that intensive statin treatment before PCI could reduce     adverse events as comparing to the placebo. In China, statin with regular dose is currently     applied to the patients admitted for Non-ST-elevation acute coronary syndrome (ACS). Here we     hypothesize that intensive statin treatment with arovastatin before PCI could further reduce     clinical adverse events.   "
243346|NCT01040949|"     Smoking among Latino males living in the U.S. is a significant public health problem, one     that can contribute to disparities in life expectancy and increase mortality. Latinos smoke     at the same rate as White males but are less likely than Whites to quit. Interventions do not     reach Latino smokers because many speak only Spanish and previous interventions have had     notable limitations. First, most have recruited volunteers, so hard-to-reach Latino smokers     likely did not participate. Second, cessation effects were short-term only. Third, no program     has attempted to boost Latino cessation rates by capitalizing on a teachable moment, a time     when quitting may seem especially relevant. To address these deficits, we propose to conduct     a teachable moment intervention trial for Latino smokers. We will attempt to capitalize on     the potential teachable moment of Latinas' pregnancy as an impetus for Latinos' cessation. We     will include couples, rather than just men, to sustain intervention effects. We will partner     with community leaders to develop an intervention based primarily on Social Cognitive Theory,     the Teachable Moment Model, and the Cognitive-Behavioral Couple Therapy Model. Some elements     will be at the individual level to help Latinos quit smoking and others will be couple-based     to improve communication and reduce stress in the postpartum relationship. The program will     be culturally sensitive to Latino values, such as familismo, valuing of and duty to the     family and personalismo, valuing warm personal relationships. We will recruit Latino couples     (n=366) into a Guia (control) arm in which men receive a culturally appropriate smoking     cessation guide, and a couple-based smoking cessation counseling arm.      Hypothesis 1: Latino expectant fathers who receive couple-based counseling to quit smoking     will be more likely to be abstinent from smoking at 28 weeks in pregnancy and 12 months     post-randomization than Latino expectant fathers who receive a self-help smoking cessation     guide.      Hypothesis 2: Couple-based counseling will improve mediators, such as couple communication     about smoking, self-efficacy, outcome expectancies, stress levels, risk perceptions, emotion,     and self-image, which in turn, will increase cessation rates among Latino expectant fathers.      Hypothesis 3: Couples in the counseling arm will have a greater increase in cessation during     pregnancy and a lower decrease in cessation at 6 and 12 months post-randomization than     couples in the Guia arm.   "
243347|NCT01040962|"     Fall risk is increased in people with diabetic peripheral neuropathy (DPN) and yet, minimal     research has been conducted to identify appropriate fall risk assessment tools and improve     our understanding of falls in these individuals. Purpose: The primary purpose of this study     is to establish a foundation of knowledge needed to address falls in people with DPN. This     will be accomplished through 1) comparing the validity of 4 fall risk assessment tools, 2)     identifying risk factors for falls and 3) determining how quality of life is influenced by     factors related to falls in people with DPN.   "
243348|NCT01040975|"     The purpose of this study is to teach primary care physicians effective ways to counsel     overweight and obese adolescent patients to attain a healthy weight. Fifty physicians and up     to 660 adolescent patients from Duke University Health System (DUHS) Primary Care Clinics     will take part in this study.      Patients will be identified by research study staff and asked if they would be willing to     have their clinic visit audio recorded for research purposes. There are three phases of data     collection. First, baseline encounters (n=200, 4 per physician) are audio recorded. Then,     half of the physicians will be randomized to receive a tailored web-based intervention     containing information about evidence-based techniques to help adolescents attain a healthy     weight. A new set of 200 encounters (4 per physician) will be audio recorded. Then, all     physicians will receive a Summary Report that outlines the adolescent's high risk behaviors     that contribute to weight (sweetened beverages, fast food, breakfast, physical activity,     screen time, and sleep) and a new set of 200 encounters will be audio recorded.      Data will be collected by trained data technicians, in-person and over the phone. Data is     collected on laptop computers and then downloaded into password protected electronic files on     a secure network server. All participants (adolescent patients and physicians) will be     assigned a code number that is the sole identifier on all study data forms. Prior to and     after coding, digital files will be stored in password protected directories to which only     the data technicians and project manager have access. The web-based intervention will be     password protected.   "
243349|NCT01040988|"     The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has     substantially changed the medical and surgical management of patients with cardiac rhythm     disease. In the case of patients with ICDs, these devices are programmed to deliver a strong     electrical shocks. In adults, multiple studies have suggested that patients at risk of     receiving shocks from their device have an increased prevalence of anxiety and depression.     Very few studies have looked at this question in children. We propose to evaluate a cohort of     patients age 6 to 20 with ICDs, compared to a cohort of patients with pacemakers, assessing     each group for the presence of depressive and anxiety disorders, including post-traumatic     stress disorder (PTSD).   "
243350|NCT01041001|"     The purpose of the study is to assess and compare the safety and efficacy of the     allogeneic-unrelated umbilical cord blood-derived mesenchymal stem cell product (Cartistem®)     to that of a microfracture treatment in patients with articular cartilage defect or injury.   "
243821|NCT01051154|"     The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration     during the first three months of treatment reduces the deterioration of nutritional status,     treatment toxicity and early mortality in children with acute lymphoblastic leukemia.   "
243355|NCT01041079|"     The purpose of this study is to determine the feasibility, safety, and efficacy of revision     gastroplasty along with other adjunct procedures in the treatment of intractable / chronic     marginal ulcers after Roux-en-Y gastric bypass. A secondary aim is the identification of good     and poor outcome predictors after revisional strategies for intractable or chronic marginal     ulcer.   "
243356|NCT01041092|"     Primary objective: To assess the efficacy of adding raloxifene as an adjunct to antipsychotic     treatment to improve negative symptoms of schizophrenia in postmenopausal women.      This is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant     treatment to antipsychotic treatment. Treatment period of 12 weeks.      The primary result obtained is that women treated with 60 mg of raloxifene compared to those     treated with a placebo show greater improvement in psychotic symptoms. The investigators also     found improved response in some aspects of social functioning and neuropsychological     functioning.   "
243357|NCT01041105|"     The goal of this study is to describe the clinical presentation, indications, and operative     treatment as well as assess the morbidity, mortality, and overall performance of revisional     Roux-en-Y gastric bypass (RYGB) after either failed or functional antireflux surgery ARS in     obese patients. With such information, we hope to determine which features might assist us in     advancing our knowledge about Gastro-Esophageal Reflux Disease GERD, the best option for     primary ARS, and mechanisms of failure in the obese population as well as in identifying     predictors of outcome after revisional surgery in this population.   "
243358|NCT01041131|"     The main aim of this study is to analyze and report the intermediate term outcomes after     laparoscopic revision Roux-en-Y gastric bypass (RYGB) surgery for failed and/or complicated     Vertical Banded Gastroplasty (VBG). The foremost outcome measurements are 1) Fat loss mainly     measured as weight loss and expressed as trends in BMI, %EWL, and/or %EBL. 2) Trend in     Comorbidity status. 3) Subjective Satisfaction and Health-Related Quality of Life HR-QoL     are measured by a standardized, non-validated satisfaction questionnaire and by a validated,     disease-specific worldwide used HR-QoL questionnaire. 4) Morbidity & Mortality include     nutritional status and metabolic complications.      Consequently, secondary objectives of this study are the following. 1) To assess failure rate     defined as percentage of excess weight loss < 50%, lowest BMI >35 for morbidly obese (MO) or     >40 for superobese (SO), and/or lack of resolution/improvement of major comorbidities at the     point in time when assessed at each postoperative year after the surgery under study. 2) To     evaluate the metabolic and nutritional status by measurements of particular clinical and     biochemical parameters.   "
243359|NCT01041144|"     The purpose of this study is to investigate the effectiveness of the new diabetes care     delivery system applied to preexisting public health care resources through advanced     information technologies such as PDA-type glucometer and the Internet on the glycemic control     of type 2 diabetes patients lived in isolated rural area.      The investigators conducted a prospective, randomized, controlled trial in patients with type     2 diabetes for 12 weeks. The intervention group was treated with the new health care delivery     system, where diabetes center provided specialized management, mediated by nurse of primary     health care posts using the Internet and the PDA-type glucometer, while the control group     with conventional health care. HbA1c, fasting plasma glucose and lipids levels were measured     at baseline and follow-up.   "
243360|NCT01041157|"     The purpose of the study is to examine the effect of the botulinum toxin injection into     muscle tone, strength and mobility with and without muscle exercise effect.   "
243361|NCT01041170|"     Background: Rimonabant, a CB1 receptor antagonist, blocks effects of cannabinoids and, in     dependent animals, elicits cannabinoid withdrawal. No studies have examined     rimonabantelicited cannabis withdrawal in humans.      Goals: (1) Determine the lowest single dose of oral rimonabant that elicits measurable     cannabinoid withdrawal. (2) Characterize cognitive performance, subjective state,     physiological condition, and regional brain activation (measured by functional magnetic     resonance imaging [fMRI]) during acute and chronic administration of oral delta     9-tetrahydrocannabinol (THC) and during cannabis withdrawal. (3) Characterize the     pharmacokinetics of oral THC and metabolites in body fluids and hair and of rimonabant in     plasma.      Subject Population: Up to 60 completing cannabis users aged 18-45 (up to 24 in Experiment I,     36 in Experiment II) and 18 completing non-drug-using controls (Experiment II). Enrollment     target is 82% Caucasian, 14% African American, 4% other; 9% Hispanic; 35% women.      Experimental Design and Methods: Experiment I: In this within-subject, randomized,     double-blind, dose-escalation study, six participants receive 7 days of THC (40-120 mg/day).     On Day 8, five participants receive 20 mg rimonabant; one receives placebo. If withdrawal     criteria (greater than or equal to 150% or 2.5-fold increase in selected visual-analog     scales) are not met in all five participants receiving rimonabant, separate groups of six are     similarly treated with 40, 60 or 80 mg rimonabant, if necessary. The PI and MRP will submit     all adverse events and relevant cardiovascular and scientific data to the IRB at the     completion of each rimonabant dose panel. When the extramural NIDA DSMB is in place, it will     review all data collected to date and develop and implement a monitoring plan, including     review on completion of each dose cohort. DSMB recommendations will be reviewed by the     Sponsor, Clinical Director and IRB before proceeding to the next dose cohort. In addition, if     any subject has an intolerable adverse event (ie, an adverse event leading to study     discontinuation) or serious adverse event in response to rimonabant on Day 8, the blind for     that subject will be broken, and a report sent to the Sponsor, the extramural NIDA DSMB when     in place and the IRB for discussion.      Experiment II: In this randomized, placebo-controlled, double-blind study, 36 participants     receive 7 days of THC (40-120 mg/day). On Day 8, 18 participants receive rimonabant dose     determined in Experiment I to elicit cannabis withdrawal; 18 participants receive placebo     rimonabant to evaluate spontaneous cannabis withdrawal. Cognitive, psychological,     physiological and hormonal measures are monitored to determine onset, magnitude, and duration     of THC intoxication and withdrawal and to correlate with THC and rimonabant pharmacokinetics.     Changes in blood oxygen level-dependent (BOLD) signal are determined with five fMRI scans     throughout the study. Eighteen non-drug-using controls undergo scanning and cognitive testing     at similar intervals.      Risks and Benefits: The proposed doses of THC and rimonabant have been well tolerated in     other studies. The most common side effects of oral THC are sedation, cognitive impairment,     euphoria, poor coordination, tachycardia, and hypotension. Spontaneous withdrawal from     cannabis is mild and medically benign. Experience with other drugs suggests that     antagonist-elicited cannabis withdrawal may have an earlier onset and greater intensity than     spontaneous cannabis withdrawal. There are no clinical benefits to participants. Scientific     benefits are greater understanding of cannabis intoxication, tolerance, and withdrawal and of     the role of rimonabant in eliciting cannabis withdrawal.   "
243362|NCT01041183|"     Patients undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of     postoperative nausea and vomiting (PONV). The investigators investigated the effect of oral     and IV ramosetron on PONV prophylaxis after laparoscopic cholecystectomy.   "
243363|NCT01041196|"     A common late complication after gastric bypass surgery is marginal ulceration that is     defined as ulcers at the margins of the gastrojejunostomy, mostly on the jejunal side. Most     marginal ulcers respond to medical therapy and complicated or complex ulcer disease warrants     operative intervention; specifically, perforated, penetrated, obstructing, bleeding and     intractable marginal ulcers require surgical intervention.      Diverse operative strategies for addressing perforated marginal ulcers after gastric bypass     have been described including I) Omental (Graham) patch repair, II) Revision of     gastrojejunostomy, III) Irrigation and drainage, IV) any previous procedure with truncal     vagotomy, V) Esophagojejunostomy, and VI) Reversal. We formally analyze our experience with     the laparoscopic resection and repair of acutely perforated marginal ulcers after Roux-en-Y     gastric bypass (RYGB), with or without concomitant resolution of technical risk factors for     marginal ulceration.   "
243364|NCT01041209|"     The aim of this study is to test if BPS (Bacterial Pneumonia Score) guided antibiotic use in     children with non severe community acquired pneumonia (CAP) will reduce antibiotic use as     compared to standard care practice (current guidelines for CAP).   "
243365|NCT01041222|"     This study will test the safety, tolerability and pharmacokinetics of single doses of ISIS     333611 administered into the spinal canal as 12 hour infusions.   "
243366|NCT01041235|"     The purpose of this study is to determine the safety profile, including the maximum tolerated     dose (MTD), of ATI-1123 a liposomal formulation of docetaxel, in the treatment of cancer     patients with advanced solid tumors.   "
245136|NCT01069575|"     The purpose of this study is to evaluate the safety, tolerability, immune response and     clinical efficacies of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A     emulsified with Montanide ISA 51 for advanced non-small cell lung cancers.   "
243376|NCT01041365|"     The overall objectives of this study are to examine the relationships between circulating     vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine     whether vitamin D deficiency in AA is responsible for ethnic differences in insulin     sensitivity and hypertension in AA and EA, as well as mechanisms underlying the association     between insulin resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is     associated with insulin sensitivity and vascular functioning, independent of adiposity, 2)     lower insulin sensitivity and vascular functioning in AA relative to EA is due to lower     circulating 25(OH)D in AA, and 3) the relationship between insulin resistance and vascular     dysfunction is mediated by 25(OH)D.      Acronyms: African American (AA), European American (EA), Serum 25-hydroxy vitamin D (25()H)D,     Body mass index (BMI), Alabama (AL).   "
243367|NCT01041248|"     Relapsing polychondritis (RP) is a rare, immune-mediated disease associated with inflammation     in cartilaginous structures and other tissues throughout the body. Prognosis can be poor,     especially in cases where there is acute involvement of the laryngotracheal cartilages     leading to airway destruction, which are resistant to treatments such as corticosteroids,     immunosuppressive or cytotoxic drugs. The pathogenesis remains unclear although it is thought     that autoimmune reactions to antigens present in cartilages, such as type II collagen and     matrilin may evoke symptoms. There are no known clinical or laboratory measures that predict     the expression of specific disease manifestations or the overall disease course. Two recently     published case reports have shown an association with elevated serum IL-6 levels and     relapsing polychondritis. In these case reports, both patients with refractory relapsing     polychondritis were treated with tocilizumab, a humanized monoclonal antibody to the     Interleukin 6 receptor, and achieved sustained response to the drug. This single patient     trial aims to evaluate the response to Tocilizumab in an eight year old boy with relapsing     polychondritis who has been shown to have elevated serum IL-6 levels and who has responded     poorly to conventional therapies. The study hypothesis is that Tocilizumab will be able to     control the disease in this patient.   "
243368|NCT01041261|"     We propose to compare the standard of care with the use of a novel medical food in 6     bariatric surgery patients by measuring outcomes of body composition, quality of life, hair     loss, muscle strength, resting energy expenditure, and biochemical parameters.   "
243369|NCT01041274|"     This study seeks to examine the effectiveness of citalopram added to treatment with any oral     or injectable second-generation antipsychotic plus standardized psychoeducation in first     episode schizophrenia patients. Because depressive symptoms are common in first episode     patients, we will test the hypothesis that adding the SSRI citalopram to a pre-established     medication regimen will improve quality of life and decrease relapse and suicidality over the     course of a 12-month trial.   "
243370|NCT01041287|"     Hypertension, or high blood pressure, is a common disease that affects many Americans, and     can lead to devastating consequences such as heart attack, stroke, and death if not treated.     Nebivolol is a medication that has been recently approved by the FDA for the treatment of     hypertension. Nebivolol has an unusual profile compared to other medications, in that its     effects may be related to release of a substance called nitric oxide. Nitric oxide is     released from the cells lining the blood vessels, and nebivolol may stimulate these cells to     release more nitric oxide. Our study will investigate whether treatment with nebivolol, as     compared to another medication called metoprolol, in hypertensive subjects will be more     effective in protecting blood vessels against the harmful effects of high blood pressure. The     mechanisms we will investigate include oxidative stress markers and circulating levels of     endothelial progenitor cells.   "
243371|NCT01041300|"     Our aim is to Test the influence of a new multichanel Transcranial Magnetic Stimulation     stimulator (Multiway) on motor excitation, in comparision to a wildly used Magstim Super     Rapid 2 single channel stimulator.      Each of the 20 Healthy subjects that are inticipated to inrole to the study wiil undergo 6     simple procedures which are designed to compare the motor threshold obtained by diffrent     combination of TMs coils (figure 8, double cone coil,H coil array) and stimulators (Multiway,     Super Rapid 2).      The entire length of the procedures is about 4 hours and all subjects will be paid for their     participation in the study.      Our main hypothesis is that the motor threshold obtained by the multichanel stimulator will     be significtly lower then the single chanel stimulator.   "
243372|NCT01041313|"     Pain is a common element of surgery. Opiates (morphine, oxycodone, hydrocodone, methadone,     fentanyl) are very helpful in decreasing pain after surgery. Unfortunately, with repeated use     opiates lose their effectiveness, such that patients need to utilize more opiates to achieve     adequate pain relief - a phenomenon called tolerance. Sometimes tolerance to a pain     reliever's effects can develop in just a few hours. It is thought that activation of the     N-methyl d-aspartate (NMDA) receptor, a switch found on the surface of nerves, is partially     responsible for opiate tolerance. Memantine is a medication that limits the activity of NMDA     receptors in the brain and spinal cord. It has been used for years to help patients with     Alzheimer's Disease. In this study, we will study the effects of memantine when combined with     opiate medications to see whether it can increase the effectiveness of opiates for pain after     surgery and reduce the side effects caused by opiates (e.g., sedation, nausea, itching).   "
243373|NCT01041326|"     This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical     prostatectomy for patients with high-risk localized disease. Its hypothesis is that such     treatment will be well tolerated with similar side effect profile as surgery alone. Patients     in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fx), respectively, to the whole     pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a     boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy,     respectively. The patient will then undergo radical prostatectomy between 4-8 weeks after     completion of radiation.   "
243374|NCT01041339|"     A blood test (2-3 cc peripheral venous blood) drawn /used from already available required lab     tests to distinguish between pericarditis accompanied with electrocardiogram (ECG) signs     mimicking infarction. A test of clinical potential if proven to be able to support either     origin of acute chest pain etiology.   "
243375|NCT01041352|"     The aim of the study is to compare anaesthesia (for back surgery) using endotracheal     intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal     mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone     position on the operation table) as regards advantages, adverse effects and time spent. The     anaesthesia in the 2 groups of patients is identical (propofol, remifentanil, rocuronium).     Two groups of 70 pt. each are included in the stud. The inclusion criterias are patients     18-70 yrs., ASA group 1-2, normal airways, patients scheduled for back surgery with an     estimated duration of less than 2 hours.      Adverse effects (related to the placement on the operation table i.e. pain in the arms or     shoulders, pain in the throat, blood in the sputum, irritation in the eyes etc.) and time     spent with all the procedures (anaesthesia, placement of the airway, surgery and emergence     from the anaesthesia are registered. The hypothesis is that the method using the laryngeal     mask is faster and with fewer adverse effects.   "
245137|NCT01069588|"     To evaluate the knee functionality, screw integrity, graft integrity, cartilage effect, and     bony ingrowth in patients treated with the CALAXO screw and MILAGRO screw two years after ACL     reconstruction.   "
243378|NCT01041391|"     This study is being conducted to examine outcome measurements on patients who undergo surgery     to removed a damage lumbar spine disc versus those that chose not to have surgery. These     outcomes are based on patient responses to quality of life and pain questionnaires.   "
243379|NCT01041404|"     This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall     survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the     chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab     (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg)     every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800     mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion     every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks)     and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab     (Herceptin) will continue until disease progression. The target sample size is 300-600     patients.   "
243380|NCT01041417|"     Peripheral arterial disease is a common condition in older adults involving poor arterial     circulation in the legs leading to leg pain and debility. The body's own circulating blood     vessel stem cells may help to improve circulation. This study will test whether treatment     with the drug granulocyte macrophage colony stimulating factor (GM-CSF) will improve symptoms     and signs of peripheral arterial disease over placebo after four weeks of therapy. As well     this study will examine whether improvements in blood vessel function can be observed.     Finally, we will measure blood vessel function and stem cell levels in order to determine     whether they can help to predict whether patients wither peripheral arterial disease will     suffer further cardiovascular complications.   "
243381|NCT01041430|"     The aim of the study was to evaluate the feasibility of day surgery for elderly patients     undergoing elective open inguinal hernia repair. Medically stable patients aged 65 years or     older, with postoperative care available at home, were randomized to receive treatment either     as day-cases or inpatients. Younger day-case patients undergoing the same procedure served as     controls. Outcome measures during two postoperative weeks were complications, unplanned     admissions and visits to the hospital, unplanned visits to primary health care and patients'     acceptance of the type of provided care. The investigators expected to find a higher degree     of satisfaction in the patient group receiving day-case care.   "
243382|NCT01041443|"     This phase I trial is studying the side effects and best dose of 5-Fluoro-2'-deoxycytidine     (FdCyd) when given together with tetrahydrouridine (THU) in treating patients with acute     myeloid leukemia (AML) or myelodysplastic syndromes (MDS). FdCyd may inhibit cancer cell     growth by increasing the production in cells of compounds that suppress growth or by     otherwise killing cells. Although FdCyd is stable as a drug solution, it is rapidly     inactivated by an enzyme present in people. THU is included in the treatment to inhibit the     enzyme, prolonging the time FdCyd remains in the body   "
243383|NCT01041456|"     The aim of this study is to describe the clinical presentation, indications, and operative     treatment as well as assess the morbidity, mortality, and overall performance of revisional     GBP after either failed and/or complicated Biliopancreatic Diversion BPD for weight loss.     With such information, we hope to determine what features might assist us in advancing our     knowledge about mechanisms of failure after primary bariatric surgery, mechanism of action of     revisional GBP, and performance of revisional GBP through traditional outcome measurements as     well as identifying predictors of good or poor outcome after revisional GBP in this specific     subpopulation.   "
243384|NCT01041469|"     The purpose of the study is to identify biological data linked to auto immune abnormalities     associated with Down Syndrome.   "
243385|NCT01041482|"     A one-arm,open,multi-center study, to evaluate sorafenib (400mg twice daily ) as a adjuvant     to prevent recurrence of RCC(renal cell carcinoma) patients after radical nephrectomy with a     high-risk of recurring. To observe disease-free survival and the survival rate in 3 years,5     years.      The purpose of this study is:        -  To study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate          in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy.        -  To observe the incidence of hand-foot skin reaction (HFSR) after the Urea (10% or 5%)          based cream intervention treatment.      The primary end point is the disease-free survival(DFS).The secondary end point is overall     survival(OS),the drug safety and tolerance, the occurrence of hand foot skin reaction(HFSR)     at the week of 3,6,12,the skin toxicity(not include HFSR) higher than CTCAE(Common     Terminology Criteria for Adverse Events) Grade 2 at the 12th week, the incidence of HFSR     after the Urea (10% or 5%) based cream intervention treatment.   "
243397|NCT01041638|"     This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18     together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell     transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18,     may find tumor cells and help kill them. Colony-stimulating factors, such as sargramostim,     may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin     may stimulate the white blood cells to kill tumor cells. Isotretinoin may help neuroblastoma     cells become more like normal cells, and to grow and spread more slowly. Giving monoclonal     antibody Ch14.18 with sargramostim, aldesleukin, and isotretinoin after autologous stem cell     transplant may be an effective treatment for neuroblastoma.   "
243398|NCT01041664|"     A key factor in the determination of body composition over the lifecourse is fat accumulation     during childhood. Periods of life associated with the greatest changes in organ development     and growth, i.e. early childhood, have the most significant effect on body composition,     energy balance, and metabolism. Early childhood (age 3 to 7 years) represents a critical     transition for the basis of adaptability in body composition, due to the rapid growth and     development that occurs. Plausibly the phenotype underlying obesity and related health risk     may be determined by body composition during this critical period.      Our previous research in children has consistently indicated that HA children accumulate     greater amounts of fat, particularly in the intra-abdominal compartment, even at similar a     BMI, and lower bone mineral content relative to EA children. The reason for these differences     in body composition over the lifecourse is not clear.      Racial/ethnic differences in risk factors for health, including 'thriftiness' in body fat     accumulation are often evident before the age of 7, suggesting that the racial/ethnic     differences in energy utilization and subsequent fat storage may be accounted for by genetic     make-up, the environment (e.g. diet), or an interaction of the two. The physiologic or     behavioral process(es) that cause(s) certain children to take a trajectory towards obesity     while others accrue less fat is not known. However, the economic decision of fuel utilization     is a physiologic trait enabling the body to choose between shuttling 'energy' towards accrual     of a particular tissue (e.g. bone vs. fat) and this trait likely has a genetic component.     This genetic component may be embedded in fat storage capacity evolved from gene by     environment interactions that promote thrift, particularly conserved in some populations.     Although genetic background plays a role, it not known whether there is a relationship     between genetic background, known candidate genes or candidate pathways and environmental     contributors (e.g. diet) that impact body composition trajectory. Of central importance to     our understanding of early fat mass accumulation in health disparities are the mechanisms     that lead to chronic disease progression.      It is likely that variations within candidate genes may have a differential impact on     individuals based on their genetic background. It is also probable that body composition is     influenced by many genes, often within the same metabolic pathways, with small individual     effects. These genes may not be significantly associated individually, but when examined as a     unit (in a candidate pathway or gene-gene interaction framework) the association becomes     significant. Further, children's early environmental exposures (e.g. diet) may interact with     both genetic background and variations in candidate genes along resulting in alterations in     body composition that predispose HA to excess fat accumulation throughout the lifecourse. To     that end, the following specific aims will be evaluated:      Aim 1. To examine the associations between genetic admixture and body composition in children     aged 3-7 years after controlling for dietary intake.        1. Hypothesis 1.1: There is a direct association between Amerindian admixture and fat mass          and in inverse association between Amerindian admixture and bone mass.        2. Hypothesis 1.2: There is a direct association between energy intake and fat accumulation          and the relationship will be particularly evident in individuals with a greater          proportion of Amerindian admixture.      Aim 2. To examine the associations between genetic admixture and bone marrow fat in children     aged 3-7 years after controlling for dietary intake.        1. Hypothesis 2.1: There is a direct association between Amerindian admixture and bone          marrow fat.        2. Hypothesis 2.2: There is a direct association between energy intake and fat accumulation          in bone marrow and the relationship will be particularly evident in individuals with a          greater proportion of Amerindian admixture.      Aim 3. To examine the relationship between variation in candidate genes and pathways and     Amerindian admixture controlling for dietary intake.      a. Hypothesis 3.1: Amerindian admixture will be associated with variations in candidate genes     and pathways known to be associated with fat accumulation.   "
243399|NCT01041677|"     This study investigates the safety of 12 weeks of treatment with R256918, in obese patients     (JNJ-16269110 and R256918 are different names for the same molecule). The primary objective     of the study is to investigate mean changes in Hepatic Triglyceride Content (HTGC), which is     the fat content of the liver, from baseline to week 6 and 12 by 1H-Magnetic Resonance     Spectroscopy (MRS), a specialized non invasive radiology test. Additional measures include     body mass index (BMI), fasting glucose,lipid levels, and blood pressure. Safety assessments     performed during the trial include laboratory tests, vital sign measurements, and adverse     event reporting.   "
243400|NCT01041690|"     Reports of the use of intravitreal bevacizumab (Avastin, Genentech) for the reduction of     neovascularization in proliferative diabetic retinopathy have demonstrated significant     regression in the number of new vessels. Reducing the vascularity of neovascular     fibrovascular tissue can potentially reduce bleeding intraoperatively and thus facilitate the     vitrectomy procedure. The investigators chose to investigate the potential benefit of the use     of preoperative bevacizumab in the management of these most complex cases.   "
243386|NCT01041495|"     Amrix (Cyclobenzaprine hydrochloride Extended release capsules) is approved by the FDA as a     muscle relaxant, indicated for the treatment of muscle spasm associated with acute, painful     musculoskeletal conditions. Cyclobenzaprine ER (Amrix TM) has a distinct pharmacokinetic     profile providing early systemic exposure and consistent plasma concentration over several     hours. Overall, a single dose of Amrix 30 mg is similar to that of cyclobenzaprine immediate     release 10 mg three times daily. This ER formula should improve compliance, with similar     efficacy and possibly less side effects as is often the case with slower release     formulations.      There are clinical studies showing that cyclobenzaprine can alleviate pain secondary to     Fibromyalgia induced muscle tone. This multi-layered evidence base suggests that     cyclobenzaprine may be able to alleviate pain in fibromyalgia. Theoretically in fibromyalgia,     pain is interpreted centrally and possibly occurs due to said muscle spasm . Cyclobenzaprine     may relieve this pain, thus allowing patients to function better during the day and sleep     better at night. Cyclobenzaprine has tricyclic antidepressant structure which may also allow     pain signal dampening in the spinal cord as well, similar to amitriptyline which is used     off-label for neuropathic pain as well.      Fibromyalgia (FM) is an illness that may involve medical, rheumatologic, autoimmune, sleep,     endocrine and psychiatric pathology. It is a syndrome of recurrent pain at trigger points.     Greater than 90% of these patients will report fatigue as a key symptom as well. There are     several investigation lines into the treatment of FM induced pain. Exercise, behavioral     therapy, amitryptiline, duloxetine, tramadol, sodium oxybate, pregabalin all have randomized     trials and almost all focus on pain. There are very few studies evaluating cyclobenzaprine     and none studying to Cyclobenzaprine ER formulation. None evaluate pain reduction, sleep and     fatigue improvement.      Cyclobenzaprine is a drug with minimal adverse effects (dry mouth, dizziness, fatigue,     constipation, somnolence, nausea, and dyspepsia). It may have a safer tolerability profile     than some of the FM medications noted above. As cyclobenzaprine is often studied and often     added as an augmentation agent to patients' regimens who suffer from acute painful     musculoskeletal conditions, the authors feel that cyclobenzaprine would also be effective in     this population. The authors wish to conduct a study to determine if cyclobenzaprine ER is     safe and tolerable in the treatment of FM induced pain, and secondary fatigue and insomnia.     This initial study may allow for continued regulatory studies with this product in FM     subjects. The authors propose a double-blind placebo controlled study to determine if     cyclobenzaprine ER is safe and effective in reversing FM induced pain, and secondary fatigue     and insomnia.   "
243387|NCT01041508|"     Stem cell transplant is an important therapeutic option for pediatric patients with relapsed     or refractory leukemia. Although, full myeloablative transplants are widely used for patients     with acute leukemia, myeloablative chemo-radiotherapy may not be feasible in some specific     settings. These settings include 1) patients with pre-existing health issues and organ     toxicities; 2) patients who have relapsed post-ablative transplant and need a second stem     cell transplant; and 3) leukemia patients with advanced disease who have been heavily     pre-treated. Clofarabine, a new purine nucleoside anti-metabolite, has the advantage of     significant antileukemic activity in addition to its possible immuno-suppressive properties.     In this study we plan to determine the maximum feasible dose (MFD) of Clofarabine in     combination with total body irradiation that can achieve durable donor engraftment without     causing excessive toxicity.   "
243388|NCT01041521|"     The study seeks to determine if the use of omega three fatty acids in individuals infected     with HIV and with high triglycerides leads to improved triglyceride levels, better blood     vessel function and decrease in the amount of obstruction in blood vessels.   "
243389|NCT01041534|"     Our aim is to complete a survey study of patients who have undergone Adjustable Gastric Band     (AGB) surgery at the University of Washington Medical Center (UWMC) and expanded to other     bariatric surgical sites outside the University of Washington (UW), which will obtain a HIPAA     waiver and a letter of cooperation) between April 1, 2007 and July 1, 2008. (Please note the     University of Washington team will not have access to the site's list of patients, only     access to coded returned surveys sent back from patients). Patients will be identified by     obtaining operative case lists from the Department of Surgery Quality Improvement Team who     maintain monthly records of bariatric procedures performed. We will obtain patient contact     information (address) and patients will be contacted by mail with the request that they     complete both the Adjustable Gastric Band (AGB) Health Survey and a standard Quality of Life     survey (EQ5D). The mailing will include an Information Statement, the AGB Survey, the EQ5D,     and a stamped return envelope. As an incentive, a $2 bill will be sent along with the first     mailing to cover the costs of completing and returning the surveys. Patients who do not     return survey within 30 days will be mailed a second survey. Patients who do not return the     second survey within 30 days will be mailed a third survey. Patients who do not return the     third survey will not be re-contacted.   "
243390|NCT01041547|"     The overall objectives of this study are to examine the relationships between circulating     vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine     whether vitamin D deficiency in African Americans (AA) and White Hispanics (WH) is     responsible for ethnic differences in insulin sensitivity and hypertension in AA, WH and     European Americans (EA), as well as mechanisms underlying the association between insulin     resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is associated with     insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin     sensitivity and vascular functioning in AA and WH relative to EA is due to lower circulating     25(OH)D in AA, and 3) the relationship between insulin resistance and vascular dysfunction is     mediated by 25(OH)D.      Acronyms: African American (AA), European American (EA), White Hispanics (WH), Serum     25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).   "
243391|NCT01041560|"     The purpose of the study is to examine connections between muscle tones, strength and     function after stroke.   "
243392|NCT01041573|"     The primary objective is to assess the systemic and local safety profile of purified     inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28     days interval up to Month 7 after the first IC51 vaccination in a pediatric population from     endemic regions.   "
243393|NCT01041586|"     To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous     upper lobe emphysema.   "
243394|NCT01041599|"     The investigators aim to investigate the relationship between albuminuria and arterial     stiffness in diabetic patients, hypertensive patients and healthy subjects.   "
243395|NCT01041612|"     The purpose of this prospective, randomized multicenter study is to determine whether there     is any difference in stent patency of covered metallic stents in terms of stent positioning,     above and across the sphincter of Oddi, in malignant bile duct obstruction.   "
243396|NCT01041625|"     This study is designed to demonstrate to efficacy and safety of Apremilast 20mg oral     administration twice daily over 12 weeks in subjects with moderate to severe lichen planus.     The hypothesis is that the subjects will achieve a significant clinical improvement in their     skin disease according to a specialized physician grading scale.   "
243424|NCT01034930|"     The aim of the investigators study is to compare, in a prospective controlled clinical trial,     the Locator® System with two other types of stress-breaking retention (Retentive Anchors and     Magnets) for implant supported overdenture in atrophic edentulous mandible, with the use of     Straumann Dental Implant System.   "
243401|NCT01041716|"     Carbapenems are a class of antibiotic agents which kill a broad spectrum of bacteria.     Infections due to gram-negative bacteria which have acquired resistance to carbapenems are     increasing, especially with Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas     aeruginosa . The optimal treatment of such infections is not known. Antibiotics like     polymyxin, tigecycline and rifampin are used alone or in combination with other antibiotics.     The outcome of using these new and old drugs is not well studied. This observational study     aims to study the clinical and microbiological outcomes of these infections and treatment at     our institution.   "
243402|NCT01041729|"     The purpose of this study is to determine the long-term effects of statins, atorvastatin,     upon Nitric Oxide, as an endothelial function assessment, and C-Reactive Protein, an     inflammatory marker, levels in patients with Peripheral Arterial Disease. These long-term     biological pleiotropic effects of statins will offer information on the role of endothelial     function and systemic inflammation in the etiopathogenesis of PAD.   "
243403|NCT01041742|"     Pulse pressure variation (PPV) known as a dynamic preload index is increasingly being used     for guide of fluid management under various clinical situations. We hypothesized that PPV     could play a role as a predictor of fluid responsiveness during displacement of the heart in     patients undergoing off-pump coronary artery bypass surgery (OPCAB).   "
243404|NCT01041755|"     Hepatic encephalopathy is caused by the effects on the brain of substances that under normal     circumstances are efficiently metabolized in the liver. The hyperammonemia is the main factor     responsible for the development of hepatic encephalopathy. In patients with cirrhosis, the     reduction in hepatocellular function and generation of portosystemic shunts contribute to     increase serum ammonium. The current therapeutic approaches, are aimed at reducing blood     ammonium levels.      Administration of the non-absorbable disaccharides, have become standard treatment of hepatic     encephalopathy.There are no adequate clinical trials comparing the efficacy of     L-Ornithine-L-Aspartate (LOLA) infusion against lactose enemas in the treatment of acute     hepatic encephalopathy.   "
243405|NCT01041768|"     200 type 2 diabetic patients -BMI between 30-35- will be submitted to bariatric surgery     (biliopancreatic diversion BPD or gastric bypass GBP ) and 100 will receive standard medical     treatment.      Subjects will be monitored during a 5 year period to assess the effects of the surgical     procedures on diabetes resolution and control at 1, 3 and 5 years.   "
243406|NCT01041781|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether     giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more     effective with or without celecoxib in treating non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed     disodium, and carboplatin to compare how well they work when given together with celecoxib or     a placebo in treating patients with advanced non-small cell lung cancer.   "
243407|NCT01041794|"     Early childhood (~4-6 years of age) is an important window for determining body composition     trajectory and may be a critical period for the development of tissue partitioning patterns     that influence later disease risk, including obesity and type 2 diabetes. As adiposity     accelerates during this critical period, deposition/ preservation of fat stores may be     sustained at the 'expense' of other tissues; i.e. energy homeostasis may be inherently biased     toward fat gain. The type and amount of tissue mass accrued in early childhood has     implications for metabolic profile, glucose/insulin homeostasis, hormone profile and resting     energy expenditure.      The interplay between fat and bone deposition represents a physiologic trait enabling the     body to choose between shuttling 'energy' towards accrual of a particular tissue. Plausibly     the phenotype underlying obesity and diabetes risk may be determined by the differentiation     of cell type (adipocyte, osteocyte, etc.) during this early stage of growth and development.     In vitro studies demonstrate transdifferentiation under the influence of specific external     stimuli, which can switch phenotypes toward other cell lineages. Further, rodent models have     demonstrated that exposure to stimuli (exercise) early in life may prevent excess fat mass     accrual in adulthood, even when the stimulus is later removed (animals are no longer     exercising). Children's early experiences (engagement in physical activity) may     'environmentally induce' alterations in body composition and predispose individuals to     diabetes throughout life (Figure 1).      Hypotheses and Specific Aims: Early growth patterns and cell differentiation may induce long     term effects on body composition by impacting biological and hormonal axes that regulate     childhood body composition. Body composition comprises not only absolute mass, but also     aspects of size, shape and location. To that end, the following specific aims will be     evaluated:        1. Quantify body composition, adipose tissue distribution, and relative tissue ratios using          magnetic resonance imaging (MRI) and dual-energy x-ray absorptiometry (DXA).             1. Hypothesis: Early partitioning of 'resources' toward fat mass accrual will lead to               decreased gains in bone mass that may persist long-term.             2. Hypothesis: Partitioning of tissue toward fat at the expense of bone mass (and               indirectly, lean mass) will result in adverse effects on glucose/insulin               metabolism, total energy expenditure, resting metabolic rate and hormone signaling.             3. Hypothesis: Children with greater levels of physical activity (energy expenditure)               will have greater partitioning towards bone (and lean) mass.        2. Quantify adipose tissue distribution and adipocyte cell size and number using MRI and          histological techniques.             1. Hypothesis: A relatively greater amount of bone marrow adipose tissue will be               apparent in those children with low levels of physical activity, resulting in the               preferential differentiation of pluripotent stem cells towards adipocytes vs               osteocytes in the bone marrow cavity.             2. A relatively greater adipocyte cell number will be apparent in those children with               low levels of physical activity indicating greater differentiation of MSC towards               adipocytes vs osteocytes.   "
243408|NCT01034722|"     The aims of this study is:        1. To investigate the diet influence on size and composition of fat globules in breast milk          under controlled diet.        2. To study the changes in globules distribution along one session of lactation and during          the day.      Study design:      Subjects:      This will be a open label study. Each subject will serve as his own control. Study population     will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western     diet and 15 Bedouins.      Each participant will be nursing a 2-5 months baby. Each participant will sign an informed     consent. Each participant will be ask to collect 2 milk samples twice a day i.e.- once on the     first nursing in the morning (in the beginning and at the end of the nursing session), and     once in the evening on last nursing again, (in the beginning and at the end). Each sample     will contain 5 ml of milk.      Participants will be asked to repeat the procedure one month later.   "
243409|NCT01034735|"     The primary objective of the trial was to assess the bioequivalence for two concentrations     (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH     freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference.      Each volunteer received three r hGH treatments, with each treatment being administered as a     single subcutaneous dose of 4 mg r-hGH in a randomized sequence with at least one week of     wash-out period between successive treatments.   "
243410|NCT01034748|"     This is single dose study of radiolabeled [14C]PF-00299804 in healthy male volunteers to     study the absorption, distribution, metabolism and elimination of PF-00299804.   "
243425|NCT01034943|"     Distal radius fractures are treated surgically if severely displaced. This study aims to     investigate the outcome after surgery. The investigators will randomize patients to either     external fixation with optional addition of k-wires or open reduction and fixation with a     volar plate.   "
243568|NCT01043965|"     The investigators aimed to evaluate microvascular circulation with novel method: real-time     myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary     arteries.      Myocardial blood flow reserve will be determined by quantitative contrast Stress     echocardiography. Diabetic individuals will be evaluate in a decompensated state (Phase 1)     and after optimization of medical treatment four months later (Phase 2).   "
243426|NCT01034956|"     Purpose of the study:      The overall goal of this study is to better understand patient experience with injectable     facial fillers so that the investigators may provide the best results for their patients. To     do this, the investigators are administering surveys to approximately 50 patients who have     been treated by Dr. Anthony P Sclafani, MD, FACS.      Participation:      Participants will be asked to complete a brief questionnaire regarding their most recent     treatment by Dr. Sclafani with a facial injectable filler. All responses will be analyzed     anonymously.   "
243427|NCT01034969|"     The Firazyr® Patient Registry is a prospective, observational study designed to document the     routine clinical outcomes over time in patients treated with Firazyr® in countries where it     is currently approved. The data collected will be used to evaluate the safety of Firazyr® in     routine clinical practice and as a data source for post-marketing investigations.   "
243411|NCT01034761|"     Introduction:      The Beers list identifies medications that should be avoided in persons 65 years or older     because they are ineffective, pose an unnecessarily high risk, or a safer alternative is     available. In a recent study, we found a high rate of prescribing of Beers list medications     to hospitalized patients. At Baystate, 41% of medical patients received at least one Beers     list drug classified as high severity, meaning it carried a high risk for an adverse drug     reaction, while 5% received 3 or more. Some Beers drugs have been associated with delirium     and falls. When compared to Baystate patients who did not receive a high severity medication,     those who did had an increased risk of mortality (7.8% vs. 5.2%), longer length of stay (5.5     days vs. 3.9 days) and higher costs ($11,240 vs. 6243).      Specific Aims:        1. Quantify the impact of synchronous electronic alerts on physician prescribing of          high-severity Beers' list drugs to hospitalized patients over the age of 65 years.        2. Compare physician reactions to each drug-specific alert      Project Description:      We will develop a series of clinical alerts in CIS, Baystate's computerized provider order     entry system, to reduce the use of potentially inappropriate medications among hospitalized     elders. We will randomize providers to electronic alerts or usual care. Whenever a provider     randomized to alerts attempts to place an order for a high-risk medication on the Beers list     and the intended recipient is over 65 years of age, a synchronous alert (i.e. a pop-up)     will inform the physician about the risks associated with the medication and will propose     safer alternatives.      We will collect data on physician ordering and patient outcomes comparing the number of Beers     list prescriptions from providers receiving electronic alerts to those not receiving alerts.     Our anticipated outcome is a decrease in inappropriate prescribing during the period when the     electronic alerts are activated. Other potential outcomes include decrease in length of stay     and a decrease in falls.   "
243412|NCT01034774|"     Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to     give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to     determine lung penetration of ACHN-490 (measured in ELF-epithelial lining fluid)after a     single dose of ACHN-490 Injection in healthy volunteers.   "
243413|NCT01034787|"     This is a Phase 2, multi-center, open-label study in patients with surgically incurable stage     III or IV uveal melanoma who have not received prior immunotherapy. CP-675,206 is thought to     stimulate patients' immune systems to attack their tumors. CP-675,206 has been shown to     induce durable tumor responses in patients with metastatic melanoma in phase 1 and phase 2     clinical studies.   "
243414|NCT01034800|"     The lack of success in treating substance abuse may be contributed to by a limited     understanding of the clinical neurobiology of drug abuse. A better understanding of such     deficits might aid in the development of more relevant pharmacological and psychosocial     treatment approaches. Thus, the purpose of this study is to test the hypothesis that     repetitive illicit drug use may be associated with cortical and subcortical structural     abnormalities, vascular abnormalities, as well as neuropsychological decrements.     Additionally, a battery of psychological tests are administered to provide information about     demographics, drug use, neurocognitive measures, and personality structures....   "
243415|NCT01034813|"     The purpose of this study is to determine the relationship between cutaneous functional     unit(CFU)recruitment throughout the available active range of motion of a prescribed joint in     normal subjects and patients with burn scars. Specifically, this study will determine if     differences in CFU recruitment exist between normal subjects and individuals with burn scars     at the dorsal hand, dorsal or volar forearm, or anterior or posterior arm during active range     of motion of the MCP joint during flexion, or the wrist or elbow during flexion or extension,     respectively.   "
243416|NCT01034826|"     Impaired glucose tolerance is a metabolic state between normal glucose homeostasis and     diabetes. Previously, prospective studies have shown higher progression rates from IGT to     diabetes in other country. But There is no prospective-multicenter based reports in Korea.     Therefore, the purpose of this study is to estimate the progression rates to impair glucose     regulation and diabetes in the Korean population-based Korea national Diabetes program.   "
243417|NCT01034839|"     In adults with acute myeloid leukemia, especially those < 60 years of age, high-dose     cytarabine consolidation therapy has been shown to influence survival, but the appropriate     dose has not been defined.   "
243418|NCT01034852|"     Specific Aims: The primary objective of this registry is to determine the percentage of     patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical     ablation procedure when the patient has a history of failing one or more previous catheter     based ablations for AF. The first 3 months following surgical ablation will be a blanking     period; any arrhythmia occurring during this time will not be used to determine success.      Primary Objectives:        1. Determine the percent success of surgical ablation for AF at 6, and 12 months both on          and off of antiarrhythmic drugs (AAD) following a failed catheter based ablation for AF        2. Record and evaluate all complications associated with the surgical procedure.      Secondary Objectives:        1. Evaluate usage of anticoagulants at 6, and 12 months.        2. Determine the percentage of Pulmonary Veins (PV) that were electrically isolated by          intra-operative, pre-surgical mapping   "
243419|NCT01034865|"     To identify risk factors for the development and diagnosis of hepatocellular CA in patients     with chronic hepatitis C and to use the data to ultimately develop an effective screening     program.   "
243420|NCT01034878|"     Sunitinib is the registered treatment for first-line therapy of metastatic clear-cell     carcinoma of the kidney.Data from the Expanded Access Study have shown activity also in     non-clear cell renal cancer (NCCRC). The aim of this study is to prospectively evaluate the     anti-tumor activity and safety of sunitinib as a first-line therapy in metastatic NCCRC     patients.   "
243421|NCT01034891|"     The purpose of this study is to increase understanding of women who are at high risk for     developing breast cancer. Data from this group will be collected and entered into a registry.     This registry serves as a clinical database to support research in prevention, early     detection and treatment of breast cancer.   "
243422|NCT01034904|"     The relevance of the study will be in establishing whether Health Related Quality of Life     (HRQoL) measures obtained repeatedly during hemophilia care are sensitive to significant     changes in health or personal circumstances related to the transition from youth to     adulthood. This may support the future use of HRQoL measures as part of routine care in order     to identify important changes that are not detectible by other clinical means.   "
243423|NCT01034917|"     This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot     clinical trial.      Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the     PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same     approach.      The aim of the study is to compare the virological efficacy of the etravirine-based regimen     with standard PI-containing regimen.   "
243449|NCT01035255|"     The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity     and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).   "
243428|NCT01034982|"     The study is designed to investigate the pharmacokinetic behaviour of the free base     formulation of AZD9668. The study will compared the relative bioavailability of the free base     formulation at two different dose levels compared to the tosylate salt formulation.   "
243429|NCT01034995|"     Primary Objective:        -  To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily,          and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as          assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton          Depression Rating Scale (HAM-D) total score.      Secondary Objectives:        -  To evaluate the tolerability and safety of SSR125543 in outpatients with major          depressive disorder        -  To evaluate plasma concentrations of SSR125543   "
243430|NCT01035008|"     Confocal laser endomicroscopy (CLE) is a novel and highly promising imaging method for that     allows in vivo imaging of the mucosal layer at resolution of approximately 1 micron. Cellular     and sub-cellular structures as well as capillaries and single red blood cells can be     visualized. CLE is now well established as a highly accurate method for distinguishing     neoplasia in the gastrointestinal tract lumen via endoscopy. A major new breakthrough is the     development of sub-millimeter CLE probes that can be passed via an image guided needle (nCLE)     into solid organs and cysts.      It is hypothesized that nCLE will help distinguish the benign, premalignant and malignant     cystic lesions of pancreas by visualizing the cellular lining of the cysts, thereby, avoiding     unnecessary surgery in patient with benign cysts and guiding to early and effective surgical     removal of high risk neoplastic lesions.      A prototype minimal risk nCLE system has been developed that can be passed via standard     endoscopic ultrasound needles into the pancreas but FDA clearance for in vivo use is not     expected until late 2010. The investigators propose to evaluate this prototype nCLE system in     vivo during endoscopic ultrasound (EUS), as an initial pilot study.   "
243431|NCT01035021|"     The aim of this study is to evaluate the success rate, insertion time and complication     depending on the use of neuromuscular blocking agent when inserting the laryngeal mask airway     (LMA).   "
243432|NCT01035034|"     The one-stop hybrid coronary revascularization combines minimally invasive direct coronary     artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced     operating room equipped with radiographic capability. This study is to compare 1-year     clinical outcomes of one-stop hybrid coronary revascularization with percutaneous coronary     intervention (PCI) in selected patients with multivessel coronary artery disease.   "
243433|NCT01035047|"     Clinical decision units (CDUs) improve resource utilization and are a recommended care option     by the American College of Cardiology / American Heart Association, but are underutilized in     non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac     magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously     assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic     process for intermediate risk patients with chest pain. The primary objective of this trial     is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to     inpatient care among patients with non-low risk acute chest pain.   "
243434|NCT01035060|"     Due to the rapid aging of the population, sarcopenia is among the greatest challenges facing     the health care system over the next quarter century. This age-related loss of skeletal     muscle mass and strength directly contributes to the incidence of functional disability,     thereby reducing independence and quality of life for the elderly. Despite increasing efforts     to combat sarcopenia, its etiology remains incompletely described. Subsequently, limited     progress has been made in developing comprehensive preventative and therapeutic strategies to     combat the problem. A decreased ability to regenerate skeletal muscle fibers through the     donation of skeletal muscle stem cells (satellite cells) is thought to contribute to     sarcopenia. However, the upstream physiological mediators that regulate this impairment are     poorly delineated.      Reduced muscle blood flow in advanced age appears to be a significant factor in reducing     skeletal muscle regenerative capacity, but few data exist to confirm this hypothesis. Thus to     test this hypothesis we aim to conduct a translational pilot trial which examines     regeneration in both young and old adults. Furthermore, we aim to determine if muscle blood     flow and satellite cell number are associated with muscle function. The central hypothesis of     this proposal is that age-related declines in skeletal muscle angiogenesis and perfusion are     significant causal factors in age-related losses of skeletal muscle mass. The specific aims     and hypotheses of the project are as follows:   "
243435|NCT01035073|"     The objective of this study is to determine the time course of duloxetine efficacy on the     symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort     Syndrome(STDS) via use of 24-hour Actigraph™ measures.      We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients     with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement     in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS     symptoms which may occur even before the antidepressant effect is observed.   "
243436|NCT01035086|"     The objective of the conducted study was to determine the efficacy of lupin kernel     fibre-enriched food (Lupinus angustifolius Boregine) on prevention of risk factors for     gastrointestinal or cardiovascular diseases.   "
243497|NCT01041963|"     A prospective, randomized, open-label, Single-center clinical trial to determine whether     Enalapril or Enalapril plus Losartan effect on Peritoneal membrane transportation.   "
243437|NCT01035099|"     The purpose of this study is to compare two different ways to administer Letrozole to     determine their effectiveness in blocking estrogen production during ovarian stimulation in     patients with breast cancer prior to chemotherapy/radiotherapy so that oocytes or embryos can     be cryopreserved and patients can possibly achieve a pregnancy after the treatment of breast     cancer.      During standard ovulation stimulation, the estrogen levels will exceed normal levels and may     reach 10 times the normal level for a 2 week period. This may not be desirable in breast     cancer patients. The study hopes to determine if the investigators can stimulate oocyte     development in the conventional way and administer different doses of Letrozole as the     oocytes develop, to keep estradiol levels low, increase the number of oocytes the     investigators are able to recover, and improve the quality of those oocytes.   "
243438|NCT01035112|"     To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging     techniques to determine which method best finds and defines breast cancer.   "
243440|NCT01035138|"     The primary objective of the original study was to assess the safety of semagacestat in     Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the     efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC     (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0     of this study (LFBF).      Preliminary results from LFAN and LFBC showed semagacestat did not slow disease progression     and was associated with worsening of clinical measures of cognition and the ability to     perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC     and LFBF have been amended to continue collecting safety data, including cognitive scores,     for at least seven months. The CT-Registry will reflect results of analyses from the original     protocol in addition to those from the amended protocol. Very few participants from LFBC     rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC     participants who rolled into LFBF were not analyzed.   "
243441|NCT01035151|"     The major aim of this study is to test the effectiveness of a bundled, multi-level     intervention (Sister to Sister) on smoking cessation outcomes in female smokers residing in     public housing neighborhoods.      Hypothesis 1.1: As compared to the control group, women receiving the Sister to Sister     Intervention will have higher 7-day point prevalence quit rates at 6- and 12-months as     validated by salivary cotinine.      Hypothesis 1.2: As compared to the control group, women receiving the Sister to Sister     Intervention will have higher 6- and 12-month prolonged smoking abstinence as validated by     salivary cotinine.   "
243442|NCT01035164|"     PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with     Alzheimer's Disease compared to healthy volunteers.   "
243443|NCT01035177|"     Numerous geometric and bone mineral density (BMD) parameters can be derived from quantitative     computed tomography (QCT) images of the proximal femur analyzed using dedicated software. The     primary objective is to evaluate the contribution of QCT-image analysis to the prediction of     the osteoporotic hip fracture risk, as compared to the reference standard, namely, dual     energy X-ray absorptiometry (DXA).      Study hypothesis: For predicting osteoporotic hip fracture, findings from QCT images of the     proximal femur analyzed using dedicated software are superior over DXA measurements of     proximal femoral BMD.   "
243444|NCT01035190|"     HYPOTHESIS:      Early prophylactic inhalation of Budesonide reduces the absolute risk of developing     bronchopulmonary dysplasia (BPD) or death in preterm infants born <28 weeks gestational age     (GA) by 10%.      PRIMARY OBJECTIVE:      To determine whether inhalation of Budesonide within 12 hours of life improves survival     without BPD at 36 weeks GA in infants born between 23 and 27 weeks GA.      SECONDARY OBJECTIVES:      To determine whether prophylactic inhalation of Budesonide affects neurodevelopment at a     corrected age of 18-22 months in preterm infants; to determine whether inhalation of     corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks     GA, BPD incidence at 36 weeks GA, and the duration of positive pressure respiratory support     or supplemental oxygen.      RATIONALE:      Pre- and postnatal exposure of the developing lung to inflammation is central to the     development of BPD and the pulmonary inflammatory response in preterms at risk of developing     BPD is established very early in life. Corticosteroids have antiinflammatory properties and     early inhalation of corticosteroids may allow for beneficial local effects on the pulmonary     system prior to the development of a full inflammatory response with a lower risk of     undesirable systemic side effects.      STUDY DESIGN:      Randomised placebo-controlled, multi-centre clinical trial.      RESEARCH PLAN:      Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of     life to Budesonide or placebo to prevent BPD. Study drugs will be administered via     Aerochamber and continued until infants are either off supplementary oxygen and positive     pressure support or have reached a GA of 32 0/7 weeks regardless of ventilatory status. The     primary outcome of survival without BPD will be determined at 36 weeks GA and BPD will be     defined according to the physiological definition. Study patients will be followed and     neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months.      CLINICAL SIGNIFICANCE:      BPD not only contributes to the mortality of preterm infants but is also associated with     impaired neurosensory development in Extremely Low Birth Weight (ELBW) survivors, frequent     readmission to hospital in the first 2 years of life, as well as with an increased risk of     asthma, lung function abnormalities and persistent respiratory symptoms in adolescence and     young adulthood. Systemic corticosteroids are effective in preventing BPD, but their use is     practically prohibited given their adverse effects on neurodevelopment. Early inhalation of     corticosteroids has been shown to be associated with secondary pulmonary benefits, but its     effect on survival without BPD and on neurodevelopment remains unclear.   "
243445|NCT01035203|"     The investigators compare the effects of two interventions, an endurance exercise program and     a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical     performance of patients with a cancer-related fatigue syndrome. The intervention will be     carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the     study.   "
243446|NCT01035216|"     This is an open-label, dose escalation study designed to characterize the safety,     tolerability, efficacy, and pharmacokinetics of GNKG168 in patients with B-CLL that has     relapsed or is refractory to all prior standard therapy, or for which no standard therapy     exists.   "
243447|NCT01035229|"     The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC)     to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after     sorafenib treatment or who are intolerant to sorafenib.   "
243448|NCT01035242|"     Over a period of 3 weeks, association splitting is compared to cognitive remediation (CogPack     training) as an add-on intervention to cognitive-behavioral therapy (CBT). Blind to treatment     assignment, both groups are assessed before intervention and eight weeks as well as six     months later with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the     Obsessive-Compulsive Inventory (OCI-R) and cognitive tests. OCD severity as measured by the     Y-BOCS total score serves as the primary outcome parameter. It is assumed that association     splitting will improve OCD severity to a greater extent than cognitive remediation.   "
243450|NCT01035268|"     This is a phase III randomized multi-center study of equivalence comparing the radiological     follow-up for patients benefiting from the correction of the esthetical relapse of the     preservative treatment by fatty transfer compared with a simple supervision.      It is planned that 440 patients participate in this study which plans to compare 2 groups of     patients: a group of patients which will benefit from the surgical treatment by transfer of     fatty tissue and a group of patients under simple supervision.      follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months,     12 months and 5 years to look for the expected unwanted effects in relation with the surgery     but also to estimate the impact of the fatty transfer on the rate of local and\or from a     distance relapse.      During these consultations, the surgeon and the patient will also estimate the cosmetic     result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized     photos.   "
243464|NCT01035450|"     The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent     is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion     revascularization at 1-year and death or myocardial infarction at 3-year after stent     implantation in the real world clinical practice.   "
243451|NCT01035281|"     Neuropathic pain occurs as a result of damage or disease of the peripheral or central nervous     system. Regardless of its cause, neuropathic pain (NeP) leads to a characteristic clinical     picture characterized by ongoing pain with steady or dysesthetic pain, such as burning or     aching, and paroxysmal pain such as shooting or stabbing. In conditions such as diabetic     neuropathy, changes in the membrane-bound proteins that form ion channels may alter the     electrical properties of the injured neuron, called remodeling. The net effect of membrane     remodeling is greater excitability of neurons, leading to a tendency towards action potential     generation and propagation in injured primary sensory neurons which occurs in the context of     nerve injury and disease. Over the past decade, a new endogenous cannabinoid     receptor-mediated system within the nervous system and upon immune-mediated cells has been     described. The cannabinoid receptor system consists of two receptors, CB1 and CB2 receptors,     as well as endogenously produced endocannabinoids which agonize these receptors.      This is a multicenter trial amongst Western Canadian sites to compare the efficacy of     nabilone versus placebo in treating patients with chronic neuropathic pain (NeP) due to     diabetic peripheral neuropathy (DPN).      A one-week screening period will occur, during which pain scores and sleep scores will be     tabulated. Following screening, a 4-week period of single blind treatment with flexible     dosing of nabilone at 0.5 - 4 mg/day will initiate. All subjects will begin with nabilone     therapy of 1 mg daily for a minimum of 4 days, with the dose of the study medication assessed     and adjusted either upwards or downwards as needed to balance efficacy for pain control with     tolerability of possible side effects. All subjects who experience at least a 30% reduction     in their weekly mean pain score during the single blind flexible dosing phase will be     considered a responder, and will be further continued in the study. During the double-blind     portion of the study, subjects randomized to nabilone will continue on the dose of nabilone     achieved at the completion of the single-blind phase, and this dose will be maintained     throughout the double-blind phase. Subjects randomized to placebo will receive 1 mg of     nabilone daily for one week, followed by 4 consecutive weeks of placebo. This dose of     nabilone will permit a tapering for those subjects achieving a higher daily dose of nabilone     during the single-blind phase, or will maintain those who were taking only 1 mg per day in     the single-blind phase, preventing an abrupt termination of treatment in subjects who are     randomized into the placebo portion of the study.   "
243452|NCT01035294|"     The purpose of this study is to evaluate the feasibility and preliminary efficacy of a     mindfulness-based behavioral intervention combining breathing and other relaxation exercises     on symptoms of anxiety in patients undergoing the implantation of an implantable cardioverter     defibrillator. This study will pilot test the feasibility and preliminary efficacy of a     mindfulness-based intervention intended to improve mindfulness and anxiety levels in ICD     (Implantable Cardioverter Defibrillators) patients. A randomized controlled study design will     be used, in which an 8 session phone-delivered mindfulness intervention will be compared to a     usual care condition among consecutive candidates for ICD procedures. The study will be     conducted at the Electrophysiology (EPS) Unit at the UMass Memorial Medical Center.     Assessments will be performed at baseline and at the end of the intervention (9 weeks after     enrollment).   "
243453|NCT01035307|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is looking at biomarkers in tissue samples from young patients     with acute myeloid leukemia previously enrolled on clinical trial POG-9421.   "
243454|NCT01035320|"     The purpose of this study is compare the effects of simvastatin+ezetimibe with those of     simvastatin alone on platelet activity, platelet-leukocyte interactions and inflammatory     variables in diabetic patients with or without impaired renal function.   "
243455|NCT01035333|"     The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping     patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication     will be added to the usual standard of care which includes education regarding diet and     exercise and monthly meetings with a registered dietician.   "
243456|NCT01035346|"     This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared     to placebo in patients with a fever due to an uncomplicated acute infection.   "
243457|NCT01035359|"     Distal radius fractures are treated surgically if severely displaced. This study aims to     investigate the outcome after surgery. The investigators will randomize patients to either     external fixation with optional addition of k-wires or open reduction and fixation with a     volar plate.   "
243458|NCT01035372|"     Dried plums (Prunus domestica L.) have traditionally been recognized for their health     benefits related to conditions such as constipation, irregular menstrual cycles and mouth     sores. This dried fruit provides high levels of fiber, vitamins and minerals. Dried plum has     also been shown in animal studies to have beneficial effects on bone and can prevent the loss     of bone caused by low hormone levels such as occurs after surgical removal of the ovaries. We     also have shown that dried plum can prevent the loss of bone associated with aging in mice.     Very few therapies for osteoporosis actually reverse bone loss and improve bone strength. The     potential therapeutic value of dried plum in men and women with hormone deficiency or     age-related osteoporosis is clear.   "
243459|NCT01035385|"     This study is a multicenter, open-label, randomized ,controlled phase III study to compare     preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4     chemotherapy in patients with resectable liver metastasis from colorectal cancer.   "
243460|NCT01035398|"     RATIONALE: Gathering information about genes, cigarette smoking, and diet may help doctors     learn more about risk factors that may cause esophageal cancer.      PURPOSE: This clinical trial is studying genetic and environmental risk factors related to     esophageal cancer.   "
243461|NCT01035411|"     This clinical study will aid future formulation development and optimisation of AZD9668     tablets by evaluating possible effects of minor changes to the formulation and process on the     rate and extent of absorption.   "
243498|NCT01041976|"     The purpose of this study is to compare 6 monthly counseling sessions to 6 monthly     information sessions on Veterans' decisions to (a) participate in vocational rehabilitation     services and (b) become employed.   "
247171|NCT01093807|"     The purpose of this study is to evaluate the efficacy and safety of various dosage     combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with     their respective components and with placebo.   "
243462|NCT01035424|"     The primary aim of the study is to assess the genotype - phenotype correlations of the CNS     manifestations of late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal, rare,     recessive disorder of the CNS in children. This study will be accomplished by comparing the     genotype to a neurologic assessment and Weill Cornell LINCL scale, the UBDRS scale, the     standardized CHQ quality of life scale, and the Mullen scale; magnetic resonance imaging     (MRI); and routine clinical evaluations. This study is designed to run parallel to a separate     study which is being done by the Department of Genetic Medicine, which will use gene transfer     to treat the central nervous system (CNS) manifestations of late infantile neuronal ceroid     lipofuscinosis.   "
243463|NCT01035437|"     This study aim is to find out what effects capecitabine, oxaliplatin and radiation therapy     following photodynamic therapy have on esophageal cancer.   "
243465|NCT01035463|"     This phase I/II trial studies the side effects and best dose of lenalidomide when given after     combination chemotherapy with or without rituximab and stem cell transplant and to see how     well it works in treating patients with persistent or recurrent non-Hodgkin lymphoma that is     resistant to chemotherapy. Biological therapies, such as lenalidomide, may stimulate the     immune system in different ways and stop cancer cells from growing. Drugs used in     chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and     help kill them or carry cancer-killing substances to them.   "
243466|NCT01035476|"     This research will examine the utility of the data card recording capacity of nasal     ventilation devices (NIPPV) in people with ALS to optimize use.   "
243467|NCT01035489|"     In heart failure patients we hypothesised that right ventricular high posterior septum is     superior to right ventricular apex in CRT and DDD pacemaker. In two separate trials we     prospectively randomized the right ventricular lead placement to find evidence of differences     in heart failure symptoms (NYHA-class), 6 minute hall walk and echocardiographic measurements     of reverse remodelling and dyssynchrony.   "
243468|NCT01035502|"     The main objective of this study is to assess the biological activity of elacytarabine in     combination with idarubicin in patients with acute myeloid leukaemia who has failed the first     course of a remission-induction treatment with cytarabine (ara-C). In addition, the     correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival     will be studied.   "
243469|NCT01035515|"     The study will examine the effects of a single dose of BIIB014 on blood pressure and     haemodynamic variables in healthy volunteers over 24 hours.   "
243470|NCT01035528|"     The field of secondary prevention remains an extremely important goal for diagnostic and     therapeutic approaches keeping in mind that 40% of all patients with acute myocardial     infarction have prediabetes, commonly as impaired glucose tolerance, which has not been known     and treated and for which there are no guidelines for treatment. In this context,     accumulating evidence shows beneficial effects for treating diabetes mellitus early in the     course of disease, whereas other evidence shows that aggressive antidiabetic therapy may be     associated with undesired risks. Accordingly, the present randomized and controlled pilot     study is designed as hypothesis creating study to create first data about potential     medication in early type 2 diabetes including impaired glucose tolerance of patients with     known coronary artery disease as means of secondary prevention by comparing oral antidiabetic     therapy with metformin with insulin glargine o.d. and by studying the respective effects on     cardiovascular function and metabolism both in the fasting state and after a standardized     meal. As diastolic myocardial function has emerged as important prognosticator, the     hypothesis was tested that treatment with insulin glargine improves myocardial function in     patients with coronary artery disease and newly diagnosed type 2 diabetes including impaired     glucose tolerance.   "
243471|NCT01035541|"     This study is designed to compare renal outcome of patients following major non-cardiac     surgery with different perioperative hemodynamic managements: a goal directed hemodynamic     management group (using PiCCO) and a control group.   "
243472|NCT01035554|"     We propose to test an intervention to increase patients' understanding of the causes,     consequences, and the rationale for treatment, of their hypertension (HTN), as a strategy for     increasing blood pressure (BP) control. The focus is on the interaction between a behavioral     intervention to reduce BP - home BP monitoring (HBPM) - and patient knowledge, which, we     propose, moderates the effect of the HBPM intervention. We hypothesize that patients who have     a better understanding of their illness and its prescribed treatment will be more adherent to     the treatment regimen, and thus will exhibit improved outcomes compared to those who have     been exposed to the same intervention, but who do not have a clear understanding of these     elements.   "
243473|NCT01035567|"     The purpose of the study is to assess the safety and efficacy of hybrid revascularization in     comparison with coronary artery bypass grafting among patients with multivessel coronary     artery disease.   "
243474|NCT01035580|"     The main objective of this study is to determine the maximum tolerable dose and safety of     intravaginal curcumin in a normal population of women (women with no evidence of cervical     cytological abnormalities by pap testing).   "
243475|NCT01035593|"     The purpose of this study will be to assess the safety, tolerability, and efficacy of rhC1INH     in renal transplant recipients with biopsy-confirmed antibody-mediated rejection (AMR) within     30 days of renal transplantation. This study will combine the investigational drug rhC1INH     with a standard regimen of plasmapheresis (PP) and intravenous immune globulin (IVIG) and     compare this to PP and IVIG alone.   "
243476|NCT01035606|"     Brain injuries affect the lives of numerous Veterans. This study examines how the brain is     affected by injury and how rehabilitation training for attention dysfunction may change brain     functioning.   "
247280|NCT01095224|"     The purpose of this study is to evaluate the safety and immune response of an     adenovirus-based HIV-1 vaccine regimen that includes two vaccines given at different time     points in HIV-uninfected adults.   "
243477|NCT01035619|"     The purpose of this study is to measure the amount of moxidectin in subjects' blood and to     measure safety. This study will enroll 36 children aged 4 to 11 years (>=12 kg) with or     without Onchocerca volvulus (O volvulus) infection. O volvulus is the nematode, or roundworm,     that causes Onchocerciasis, also known as river blindness. Each subject will receive a single     dose of 4 mg moxidectin (orally administered) and will be followed inpatient from screening     through day 13 and as outpatients through month 6. The study will take place at a single     research center.   "
243510|NCT01042132|"     To what extent the cardiopulmonary and inflammatory response is affected by initial femoral     intramedullary nailing in the already traumatized and inflammatory activated patient was     analyzed in the present study with the attention to survey the additional burden of this     operative treatment. The patients are monitored with a pulmonary catheter, and blood samples     for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and     postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is     compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared     with a standard reaming technique (TR).   "
243478|NCT01035632|"     Background:      - Relapse following cigarette abstinence remains a common problem for smokers who are     attempting to quit. Most research has focused on the acute withdrawal phase that occurs     within the first 48 hours to 1 week after quitting; however, more information is needed on     the experiences of smokers in longer durations of abstinence.      Objectives:        -  To study the effects of long-term smoking abstinence.        -  To study the effects of cigarette-related cues on craving in longer periods of smoking          abstinence.      Eligibility:      - Individuals at least 18 years of age who are current smokers (at least 10 cigarettes per     day) and who want to quit but are not currently attempting to quit.      Design:        -  Participants will be randomly assigned to abstain from all nicotine use for 7, 14, or 35          days. A fourth group of participants will also abstain for 35 days, but will undergo          more testing sessions than the other groups.        -  All participants will have an initial orientation session in which they will complete          questionnaires about their smoking habits and will respond to smoking-related cues to          provide information about their cravings.        -  Participants will visit the clinic daily during their abstinence period, and provide          urine and breath samples to test for tobacco use. Participants will receive compensation          for every day that they do not use tobacco.        -  On the end day of the abstinence period, participants will return to the clinic, provide          urine and breath samples, and undergo testing of their responses to smoking-related          cues. Participants in the fourth group will have these tests on Days 7, 14, and 35 of          abstinence; other participants will have the tests only once, at the end of their          abstinence period.        -  After the required abstinence period, participants will enter a 5-day step-down period.          They will continue to report to the clinic for breath and urine testing, and they will          receive payments for abstinence that decrease in value across days.        -  After the step-down period, for the final 12 days of the study, participants will report          to the clinic every 3 days to give urine and breath samples and to report the number of          cigarettes smoked.   "
243479|NCT01035645|"     GSK1070806 is a humanised monoclonal antibody that blocks a protein present in the body     called Interleukin-18. The main purpose of this study is to test GSK1070806 in healthy and     obese male subjects with normal immune systems to find out how safe this drug is and how long     the body takes to get rid of it. The study consists of 2 parts. Part 1 will consist of 6     groups of healthy male subjects and Part 2 will consist of 3 groups of obese male subjects. A     total of 89 subjects is planned for this study. Subjects in each group will receive one dose     of the study drug or placebo. Dosing in Part 2 will not start until dosing of the first 4     groups is completed in Part 1 and the preliminary safety and pharmacokinetic data from these     4 groups in Part 1 has been reviewed. Both parts will be conducted single-blind and with a     placebo control. Within each group, allocation of subjects to placebo or active treatment     (GSK1070806) will be randomised.   "
243480|NCT01035658|"     In this study, patients with relapsed or refractory ovarian cancer will receive treatment     with pazopanib and liposomal doxorubicin (Doxil) until disease progression or unacceptable     toxicity occurs. The Phase I portion will define the dose limiting toxicity (DLT) of     pazopanib and liposomal doxorubicin when administered in combination. Once the maximum     tolerated dose has been identified in the Phase I portion, the Phase II portion will evaluate     efficacy and safety of this combination in the same patient population.   "
243481|NCT01035671|"     This is a Phase 2a double-blind, placebo-controlled study with two dose levels of A0001 given     twice daily for 28 days. Potential subjects will be screened first to determine eligibility,     after which they will be randomized to receive either a high dose of A0001, a low dose of     A0001 or placebo for 28 days.      Eligible subjects will return within 21 days of screening for the baseline visit and     randomization to one of three potential treatments. The subjects will be required to take 3     capsules of study medication in the morning with a morning meal and 3 capsules of study     medication at night with an evening meal for 28 days. Additional visits to the clinic are     planned for Day 14 and Day 28, at which time a number of clinical and biochemical assessments     will be done.   "
243482|NCT01035697|"     This observational study assessed whether measurements of certain pro-inflammatory and     anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up     to day of life 21 can predict cerebral palsy at 18-22 months corrected age.   "
243483|NCT01035723|"     Background:      - New research on genetics and the human genome has helped to identify certain genes that     affect specific parts of the brain, including the parts that may be involved in drug use and     dependency. Researchers are interested in studying both genetic information and brain     activity to better understand variations in brain function among individuals.      Objectives:      - To study brain activity in conjunction with specific genetic information provided by     healthy volunteers including smokers, non-smokers, people with drug dependence, and those who     do not have any dependence on any substance.      Eligibility:      - Healthy volunteers between 18 and 50 years of age.      Design:        -  This is an 8 10 hour study which may be completed in 1, 2, or 3 visits.        -  Participants will complete questionnaires about emotional and psychological responses to          different situations, including stressful situations.        -  Participants will have a training session in a mock (fake) scanner to practice tasks to          be completed in the real scanner.        -  Participants will have the following two types of magnetic resonance imaging (MRI) scans          in one scan session of the brain:        -  A structural MRI scan to provide basic information about each participant's brain.        -  A functional MRI scanning session, in which participants will perform a memory task to          provide information about brain activity.        -  Participants will provide blood samples for research and testing.   "
243484|NCT01035749|"     The purpose of this study is to show that vaccination with a single dose of GSK Biologicals'     pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines     Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a     pandemic influenza vaccine.   "
243485|NCT01041807|"     This survey is conducted for preparing application material for re-examination under the     Pharmaceutical Affairs Law and its Enforcement Regulation; its aim is to reconfirm the     clinical usefulness of COZAAR XQ through collecting the safety and efficacy information     according to the Re-examination Regulation for New Drugs.   "
243538|NCT01043562|"     Patients who receive an implantable cardioverter-defibrillator (ICD) usually undergo testing     at the end of the ICD procedure to measure the amount of energy able to successfully     defibrillate the heart (defibrillation threshold testing, or DFT). This study proposes to     perform that measurement in pediatric patients already undergoing clinically necessary ICD     procedures, with the measurement performed using a binary search method that has been     previously validated in adult cohorts. We hypothesize that pediatric DFTs, when precisely     measured, may be lower than previously assumed from extrapolation of adult data.   "
243569|NCT01043978|"     The overall goal of this project is to identify strategies to prevent overfeeding during     infancy. One objective is to evaluate the impact on intake of allowing the infant greater     control over the amount consumed when feeding from a bottle. This will be accomplished via     the use of a novel nipple that mimics (functionally) the nipple of a human breast and allows     the infant to self-regulate milk flow. The second objective is to evaluate the relationship     between parental feeding styles and infant intake.   "
243486|NCT01041820|"     Early childhood (~3-7 years of age) is an important window for determining body composition     trajectory and may be a critical period for the development of tissue partitioning patterns     that influence obesity risk. As adiposity accelerates during this critical period,     deposition/ preservation of fat stores may be sustained at the 'expense' of other tissues;     i.e. energy homeostasis may be inherently biased toward fat gain. The type and amount of     tissue mass accrued in early childhood has implications for metabolic profile,     glucose/insulin homeostasis, hormone profile and resting energy expenditure.      The interplay between fat and bone deposition represents a physiologic trait enabling the     body to choose between shuttling 'energy' towards accrual of a particular tissue. Plausibly     the phenotype underlying obesity and diabetes risk may be determined by the differentiation     of cell type (adipocyte, osteocyte, etc.) during this early stage of growth and development.     In vitro studies demonstrate transdifferentiation under the influence of specific external     stimuli, which can switch phenotypes toward other cell lineages. Further, rodent models have     demonstrated that exposure to stimuli (exercise) early in life may prevent excess fat mass     accrual in adulthood, even when the stimulus is later removed (animals are no longer     exercising). Children's early experiences (engagement in physical activity vs. sedentary     behavior) may 'environmentally induce' alterations in body composition and predispose     individuals to obesity throughout life.      Aim 1. To examine the associations between body composition via DXA and objectively-measured     physical activity/inactivity.        1. Hypothesis 1.1: There is a positive association between physical activity and bone mass.        2. Hypothesis 1.2: There is a positive association between sedentary behavior and total fat          mass.           Aim2. To examine the associations between adipose tissue distribution via MRI and          objectively-measured physical activity/inactivity.        3. Hypothesis 2.1: There is an inverse association between physical activity and bone          marrow adipose tissue.        4. Hypothesis 2.2: There is a positive association between sedentary behavior and bone          marrow adipose tissue.   "
243487|NCT01041833|"     BACKGROUND Platinum-based chemotherapy (CT) is the standard treatment for advanced     non-small-cell lung cancer (NSCLC). Unfortunately, the survival and response rate (RR) to CT     is poor. There is great interest in new treatment strategies. One of this new strategies     include the use of retinoids such as atRA. The synergistic effect of cytotoxic agents with     retinoids has been demonstrated in lung cancer. At the INCan, our work group carried out a     phase II study trial that included 107 patients with advanced NSCLC. They were randomized to     receive atRA (20-mg/m2) or placebo combined with 80 mg/m2 of cisplatin and 175 mg/m2 of     paclitaxel. The results showed a significant increase in the RR of the atRA group, reaching     55.8% ( 95% CI; 46.6-64.9%) compared with 25.4% (95% CI, 21.3-29.5%; p = 0.001) in patients     who received placebo. Median Progression-free survival (PFS) in the atRA group was 8.9     months, while for those of placebo, PFS was 6.0 months (p = 0.008). There were no significant     differences in the grade 3-4 side effects between groups, except for hypertriglycemia, which     presented with greater frequency in the atRA group (p = 0.05). Immunohistochemical stains     determine the RAR B2 expression in 6 of 60 tumor samples analyzed; however, all samples     expressed RAR B2 in adjacent normal tissue.      HYPOTHESIS Patients with NSCLC who receive the scheme combined with first-line CT plus 45     mg/m2 of atRA will have a greater PFS and RR to CT with an acceptable toxicological profile.      OBJECTIVES        1. Obtain a greater RR to CT and PFS in patients with advanced NSCLC who receive cisplatin-          and paclitaxel-based CT combined with a 45-mg/m2 daily dose of atRA with an acceptable          toxicological profile .        2. Evaluate the benefit of RAR beta and RAR alfa expression as a response biomarker.      METHODS Three hundred and thirty patients with advanced NSCLC will be included to receive     Paclitaxel 175 mg/m2 and Cisplatin 80 mg/m2 (PC) every 21 days for 6 cycles. Patients will be     randomized to receive ATRA 45 mg2/day or placebo 1 week before treatment until completing six     cycles. Imaging studies will be performed prior and after two cycles of CT to assess     response. RAR beta and RAR alfa expression will be analyzed by immunohistochemistry in lung     tumoral tissue and in the adjacent lung tissue.   "
243488|NCT01041846|"     The purpose of this study is to evaluate the effectiveness and safety of decitabine (Dacogen)     intravenous injection in patients with Myelodysplastic Syndrome.   "
243489|NCT01041859|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally     administered tapentadol extended release (ER) at dosages of 100 to 250 mg twice daily     compared with placebo in patients with moderate to severe pain due to chronic, painful     diabetic peripheral neuropathy (DPN) who tolerated tapentadol (ER) and have an initial     treatment effect (pain improvement) after a 3-week, open-label titration period.   "
243490|NCT01041872|"     The objective of this study is to evaluate the influence of different propofol     formulations(plain or with lidocaine)on anesthetic induction. Propofol plain or with     lidocaine is administered using a closed-loop algorithm in order to reach a Bispectral Index     target of 50.   "
243491|NCT01041885|"     The purpose of this study is to investigate whether the INSTRUCT therapy is safe and     effective in the treatment of cartilage defects of the knee.   "
243492|NCT01041898|"     The overarching hypothesis of this proposal is that obesity and positive energy balance in     children promote both low bone mass accrual and risk for diabetes through events that are     mechanistically associated and that involve bone as an endocrine organ. Recent studies     conducted in mice have uncovered the presence of a unique bone-fat-pancreas axis that     regulates energy homeostasis, coordinates energy partitioning between bone and adipose     tissue, and impacts insulin sensitivity. The adipocyte-derived hormone leptin, elevated     levels of which reflect both adiposity and positive energy balance, inhibits bone formation     via sympathetic activation. Decreased bone formation in turn depresses insulin sensitivity     and secretion via decreased production of undercarboxylated osteocalcin (unOC), a novel     bone-derived hormone. Although data from mice are compelling, this novel pathway has not been     widely tested in humans. Sparse data from adult men and women suggest that this axis is     active in humans, and that unOC is regulated in part by exercise. No data are available     regarding the bone-fat-pancreas axis in children. Because the foundations of body composition     trajectories and metabolic programming are established early in the life course, childhood,     particularly during early stages of growth and development, is an especially salient time     period for evaluating the bone-fat-pancreas axis. With this pilot grant, we propose to gather     evidence that these interrelationships exist in children. The data from this project will be     used to prepare an NIH R01 proposal to conduct a lifestyle-based intervention in children     aimed both at reducing risk for osteoporosis and type 2 diabetes, and at identifying the role     of unOC in metabolism and tissue partitioning.      Hypothesis 1: Obesity and positive energy balance in children decrease bone mass via elevated     leptin.      Specific Aim 1: Determine the association between bone mass by DXA and serum leptin     concentration in lean and obese children. We predict that body weight will be positively     associated with bone mass, but that at any given body weight, bone mass will be lower in     obese children, and that this difference will be explained by leptin.      Hypothesis 2: Leptin-mediated suppression of unOC decreases insulin secretion through action     on the β-cell, and decreases insulin sensitivity by inhibiting secretion of adiponectin from     adipose tissue.      Specific Aim 2: Determine the association between insulin secretion during oral glucose     tolerance test (OGTT; from C-peptide modeling) and serum unOC in lean and obese children.     Determine the association between insulin sensitivity during OGTT (derived from mathematical     modeling) and serum unOC in lean and obese children. Obese children are less insulin     sensitive, and in an absolute sense, secrete more insulin. However, we predict that at any     given degree of insulin sensitivity, insulin secretion will be lower in obese children, and     that this difference will be explained by unOC. unOC will be inversely associated with serum     leptin, and will be positively associated with adiponectin and insulin sensitivity.      Hypothesis 3: Physical activity prevents leptin suppression of unOC and partitions energy     towards bone mineral at the expense of bone marrow adipose tissue.      Specific Aim 3: Assess the interrelationships among physical activity using accelerometry,     bone mass using DXA and bone marrow adipose tissue using magnetic resonance imaging. We     predict that at any given level of serum leptin, active children will have greater unOC.     Further, we predict that at any given body weight, active children will have greater bone     mass and lesser bone marrow adipose tissue than inactive children.   "
243493|NCT01041911|"     The purpose of this study is to determine the safe and efficacious dose of Euphorbia     prostrata for control of per rectal bleeding in patients with first and second degree     hemorrhoids.   "
243494|NCT01041924|"     Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide     (CO2) in the blood. In heart failure, where the heart muscle is damaged and therefore does     not pump as well, this reflex is exaggerated. The result is a vicious circle: blood CO2     levels fluctuate wildly and as a result breathing also fluctuates with patients     hyperventilating at times and briefly stopping breathing at others. During sleep this is     called central sleep apnoea (CSA).      Patients with CSA wake up throughout the night and whilst some patients are oblivious to     this, others are consciously breathless and many patients are tired during the day and feel     unable to perform their daily activities.      As part of the body's stress response to the erratic pattern of breathing, both blood     pressure and heart rate may rise to a level that is harmful in a failing heart, exacerbating     the underlying heart failure. Indeed patients who demonstrate this CSA die sooner than those     who have heart failure and stable breathing.      There are no proven specific therapies for CSA that stabilise breathing, improve sleep     quality, and prolong life. We have designed a system which delivers very small doses of CO2,     when the blood level of CO2 is predicted to be low. During short daytime recordings, using     this system, we have demonstrated that it is possible to stabilise the body's CO2 levels.      We aim to test what happens when CO2 is given overnight whilst the patient is sleeping to see     whether we can stabilise their breathing over longer durations and whether sleep quality     could be improved so that patients are less tired during the day. In addition, we would like     to measure whether the stress response is lessened if the breathing is successfully     stabilised.   "
243495|NCT01041937|"     The primary purpose of TKA Randomized Clinical Trial- Cemented versus Cementless Tibial     Prosthesis Study will determine whether there is a significant difference in patient-reported     and measured clinical outcomes (e.g. pain, function, length of recovery, and patient     satisfaction) between subjects treated with a cementless tibial prosthesis (the cementless     group) and those treated with cemented tibial prosthesis (the cement group) over the first     two postoperative years. Radiographs will be assessed before surgery and at established     post-operative intervals to determine if there are any significant differences between     patients in the two groups and to assess the influence of component fixation on radiographic     stability over time. Complication and revision rates will also be assessed for comparison.   "
243496|NCT01041950|"     The purpose of this study is to determine if usage of early lumbar drainage leads to less     shunt surgery and less catheter associated complications in patients with communicating     hydrocephalus after intracerebral hemorrhage with severe ventricular involvement.   "
243499|NCT01041989|"     This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention     study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons     at an increased dementia risk. The 2-year multi-domain life-style intervention includes     nutritional guidance, exercise, cognitive training, increased social activity, and intensive     monitoring and management of metabolic and vascular risk factors. The primary outcome is     cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and     Stroop and Trail Making tests to capture early cognitive impairment typical for both     Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention     will reduce cognitive impairment in the study group compared to the control group during the     initial 2-year intervention period and reduce dementia incidence after the 7-year extended     follow-up.   "
243500|NCT01042002|"     Exercise training is proved to protect against premature cardiovascular mortality.     Additionally there is evidence that relatively high exercise intensity may be an important     factor for improving aerobic capacity and endothelial function in patients with     post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in     overweight and obese individuals.      The aims of this study is to investigate if High-intensity exercise before a gastric bypass     operation will decrease hospitalization days and complications after the gastric bypass.   "
243501|NCT01042015|"     The goal of this study is to rapidly cool trauma victims who have suffered cardiac arrest     from bleeding with a flush of ice-cold sodium chloride to preserve the patient to enable     surgical control of bleeding, followed by delayed resuscitation with cardiopulmonary bypass.   "
243502|NCT01042028|"     This is an open multicenter randomized phase I/II study. The main purpose with this study is     to investigate dose and efficacy of a combination of Irinotecan, Cetuximab and Everolimus     given biweekly to patients with local advanced or metastatic pancreatic cancer AFTER     progression from 1. line treatment with Gemcitabine.   "
243503|NCT01042041|"     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Chemoembolization kills tumor cells by blocking the     blood flow to the tumor and keeping chemotherapy drugs near the tumor.      PURPOSE: This phase I trial is studying side effects and best dose of sorafenib tosylate when     given together with chemoembolization in treating patients with unresectable liver cancer.   "
243504|NCT01042054|"     The provision of adequate pain relief following major liver surgery is essential, not only     for patient comfort, but for the prevention of complications, such as chest infection.      Commonly, pain relief in the first few days after surgery is provided by epidural analgesia.     Drugs are delivered to the area around the spinal cord, through a fine plastic tube placed in     the patients back, and this blocks sensation from the abdomen downwards, thereby providing     effective pain relief without the need for opiate analgesia (e.g. morphine). Opiate analgesia     can cause nausea, drowsiness and constipation, and its use should be minimised. Epidurals,     however, can be associated with some problematic side effects. Low blood pressure is commonly     encountered, and not only can its treatment be associated with complications, but patients     are often confined to bed.      Mobility can also be limited if muscle function in the legs, (in addition to sensation), is     inadvertently affected by the epidural drugs. Other problems associated with epidural use are     the relatively common failure of the technique to provide adequate analgesia (20%), and some     extremely rare but potentially disastrous complications of epidural insertion.      An alternative technique, is the provision of pain relief directly into the wound, via one or     more multi−holed tubes(catheters), placed either in or close to the wound. This technique     alone does not provide as effective analgesia as a functioning epidural, but when combined     with other intravenous or oral analgesia, has been shown to be effective following a variety     of surgical procedures.      It is hypothesised that, following major liver surgery, the use of this latter technique may     result in superior outcome and faster recovery, when compared with epidural, by avoidance of     the side effects and complications discussed above.      In this study, patients scheduled to undergo major liver surgery at the Royal Infirmary of     Edinburgh with be randomly assigned to receive the first two days of pain relief either by     epidural, or by wound catheter plus additional analgesia. Both groups will then receive an     identical oral analgesic regime for the remainder of the hospital stay.      Outcomes of interest will include the quality of pain relief attained, patient mobility,     frequency of complications, and overall recovery time.   "
243505|NCT01042067|"     The study is a national multicenter prospective observational study, including 200 patients.     The main purpose of this study is to explore in more detail the influence of genetic     variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on     warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of     treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K     dependent proteins predict dosing and adverse events during warfarin treatment. The main aim     is to individualize warfarin therapy and establish a treatment algorithm based on genotype     and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.   "
243506|NCT01042080|"     NAVA used the electrical activity of the diaphragm (EAdi) to initiate and deliver in     proportion of an inspiratory assistance. During inspiration, EAdi signal occurred earlier     than airflow or pressure variations in the airway. The investigators hypothesized that NAVA     improved patient-ventilator synchrony and reduced inspiratory workload as compared with     pressure support ventilation delivered at two different cycling criteria (25 and 50 %).   "
243507|NCT01042093|"     The purpose of this study is to compare different medication combinations used in a     periarticular injection after total knee replacement surgery(TKR). A periarticular injection     is an injection that is given into the tissues surrounding the knee joint. The injection is     given while the patient is still in surgery.      The study will compare the level of pain management, length of hospital stay, range of motion     and side effects from subjects receiving one of four different combinations of medication in     a periarticular injection. The medications used in the injections are approved medications     routinely used for pain management.      Approximately 160 subjects will participate in this study. The surgeon, study personnel, and     patients will be blinded to the combination of medications each patient receives. The     pharmacist will prepare the 4 different combinations of medications, randomize each patient     to the particular combination of medications, and maintain the study drug documentation.   "
243508|NCT01042106|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes     mellitus and healthy adults.   "
243509|NCT01042119|"     The neurotoxin Botox (botulinum neurotoxin type A) is shown to be effective in the treatment     of therapy refractory overactive bladder syndrome. Our data suggests a longer during efficacy     than known from the use in striated muscle.      The aim of our study is to analyze short- and longterm efficacy after Botox treatment and to     evaluate risk factors for non-responders and side effects such as urinary retention.   "
243511|NCT01043198|"     Comparative genomic hybridization (CGH) array technology has been used in numerous studies on     mental retardation, and few chromosomal abnormalities have been identified in patients.     Because chromosomal abnormalities have still been associated with obesity, we can expect that     syndromic obesity is also associated with small deletions/duplications. Characterization of     deleted or duplicated loci in these obese patients would mean that these loci include genes     implicated in obesity. This will permit to propose new gene(s) involved in obesity. (In     french: Caractérisation phénotypique et recherche de REManiements chromosomiques chez des     patients présentant une OBésité syndromique de cause non identifiée : REMOB)   "
243512|NCT01043211|"     The purpose of this study is to generate further insight into the role and effectiveness of     the amide local anesthetic lidocaine as an adjuvant postoperative analgesic after adult spine     surgery. The effect of perioperative intravenous lidocaine infusion on postoperative     rehabilitation and the inflammatory response will also be examined.   "
243513|NCT01043224|"     The purpose of this trial is to compare the anti-psoriatic effect of a topical combination     product containing clobetasol propionate and calcipotriol in an ointment formulation to the     single components in the same vehicle using a psoriasis plaque test design.   "
243514|NCT01043237|"     The purpose of this study is to determine if coronary artery disease can be detected using an     electronic, acoustic recording instrument. The presence or absence of abnormal pathology will     be confirmed by diagnostic angiography as part of the normal patient care at this     institution.   "
243515|NCT01043250|"     In this study, we are going to investigate quantitative and qualitative natures of appetite     and eating-behavior changes induced by atypical antipsychotics, i.e., risperidone, olanzapine     and aripiprazole, in schizophrenia patients.   "
243516|NCT01043263|"     The purpose of this study is to determine the efficacy and safety of EN3324 (axomadol) in     subjects with moderate to severe chronic low back pain   "
243517|NCT01043276|"     The purpose of this study if to investiagte the time course of PF-00258210 plasma     concentration in the presence or absence of PF-00610335 administered via oral inhalation     using dry powder inhalers   "
243518|NCT01043289|"     The purpose of this study is to determine whether morning bright light therapy is an     effective treatment for major depression during pregnancy compared with low-intensity placebo     light therapy, when administered 60 minutes daily for 5 weeks.   "
243519|NCT01043302|"     The purpose of this study is to determine whether whether surgical resection followed by     chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and     quality of life (QOL) in patients with primary intestinal lymphoma.   "
243520|NCT01043315|"     The purpose of this study is to identify cardiac patients' degree of unappreciated mild     impairment in cognitive function patterns of cognitive function, and influencing factors     related to cognitive functioning during hospitalization. The results from the study will     contribute to tailoring the delivery of patient education to optimize patient understanding     of information in future clinical practice.      It is hypothesized that the study will demonstrate the following:        1. The degree of cognitive function for patients hospitalized in a CICU will be below the          scores for normal functioning adults.        2. Patients with acute cardiovascular conditions will score differently in cognitive          functioning at various times throughout their hospitalization.        3. Relationships between cognitive function and following variables:             -  Patients with greater sleep deprivation or fatigue will exhibit lower cognitive               functioning.             -  Patients with greater hunger will exhibit lower cognitive functioning.             -  Patients who are experiencing greater anxiety will exhibit lower cognitive               functioning.             -  Patients who are experiencing depression will exhibit lower cognitive functioning.             -  Patients who have undergone or will undergo shortly treatment or procedures will               exhibit lower cognitive functioning.   "
243521|NCT01043328|"     Human papillomavirus (HPV) is one of the most prevalent infections in the world with several     millions of new cases diagnosed yearly. Oral HPV infection may be associated with different     diseases of oral cavities including some cases of oropharyngeal cancer.      The aim of this report is to detect the presence of HPV DNA in samples of biopsies, oral     swabs, saliva and serum of patient with oral squamous cell carcinoma (OSCC) and controls. We     hoped to find there is correlation among the presence of HPV DNA in the several biological     materials and if it is possible to use the saliva as screening to HPV DNA detection. The     presence of tumor HPV DNA in blood may be of diagnostic and prognostic value.   "
243522|NCT01043341|"     The purpose of this study was to analyze the knowledge and attitude about HPV vaccines among     Brazilian women after an educative intervention. The knowledge was measured on sexual     behavior and HPV infection. The attitude was measured on acceptance of vaccines.   "
243539|NCT01043575|"     The primary objective of this study is to characterize rifapentine drug levels in patients     with TB in relationship to its effectiveness in treating TB and any adverse effects     experienced by participants.   "
243540|NCT01043588|"     The aim of this study is to compare medical efficacy and cost effectiveness of two surgical     options for obstructive BPH management : transurethral resection of the prostate with photo     selective vaporization of the prostate using the high powered 532nm laser.   "
243541|NCT01043601|"     The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol     fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients     with moderate to very severe chronic obstructive pulmonary disease (COPD).   "
243822|NCT01051167|"     Cetuximab is normally given as a weekly schedule in the therapy of patients with metastatic     colorectal cancer.      In order to improve the convenience for the patients in first line-therapy this study will     evaluate the efficacy and safety of a bi-weekly combination of cetuximab with FOLFOX.   "
243580|NCT01044121|"     The primary study objective is to determine whether mattress firmness affects pain in     patients with chronic low-back pain. We hypothesize that mattresses that differ in their     firmness and support should have a varying effect on low-back pain patients' level of pain     and pain-related disability. We also seek to test the hypothesis that the optimal mattress     might vary from person to person.      In this regard, we will test:        1. Whether there is a single mattress that is superior to the others in terms of reducing          low-back pain and pain related disability.        2. Whether the optimal mattress for reducing pain varies in the observed population.   "
243523|NCT01043354|"     Background:      This is a randomized controlled trial (RCT) of two novel behavioral interventions to enhance     treatment adherence and improve low-density lipoprotein cholesterol (LDL) in diabetes. Among     adults with diabetes, high LDL greatly increases their risk for cardiovascular disease (CVD).     Despite the proven efficacy of LDL control(<100 mg/dL) in preventing CVD, the control rate is     low. Poor adherence to treatment(diet, exercise and medication) is the main reason for this     poor control.      Aims: This study will test two telephone-delivered interventions, a Transtheoretical     stage-matched intervention (SMI) and a Prospect theory-based framing effects intervention     (FEI). The investigators hypothesize that both SMI and FEI will be more effective in     improving LDL control than an attention placebo intervention (API) at 6 months. SMI and FEI     will also be more effective in increasing adherence to medications, diet and exercise than     API at 6 months.      Methods:      The investigators will recruit 246 adults with diabetes and high LDL despite being on     medications. Key outcomes are adherence to diet, exercise and medication, and LDL control.     The interventions will be standardized and fidelity of intervention maintained. Using a     blinded RCT the investigators will test the effect of SMI and FEI compared to API on LDL     control and adherence. All analyses will be intent to treat.      Significance:      This project will provide important information to improve diabetes-related behavior and lead     to the implementation of novel interventions for lowering LDL in primary care settings among     adults with diabetes. It may also provide the scientific rationale to use such approaches to     control other risk factors in diabetes.   "
243524|NCT01043367|"     The purpose of the study is to assess the efficacy of DEPREXIL administration in combination     with relaxation psychotherapy in the treatment of patients with signs and symptoms of     depression. The duration of this double-blind placebo controlled phase 3 clinical trial will     be 24 weeks. The estimated number of persons to be recruited and randomized for the study is     200.   "
243525|NCT01043380|"     The purpose of this study was to evaluate the difference in the effect of coronary plaque     regression (as measured by intravascular ultrasound [IVUS] imaging) between cholesterol     absorption inhibitor and cholesterol synthesis inhibitor.   "
243526|NCT01043393|"     The objective of this study is to evaluate the potential of desoximetasone 0.25% topical     spray to suppress HPA axis function. The potential for adrenal suppression will be assessed     following multiple dosing with Desoximetasone 0.25% Topical Spray in patients with moderate     to severe plaque psoriasis. The secondary objectives are to evaluate the efficacy parameters     and to evaluate the adverse event (AE) profile.   "
243527|NCT01043406|"     The purpose of this prospective, single-arm, unblinded, multicenter clinical study is to     evaluate the safety and effectiveness of the NeuroVista Seizure Advisory System (SAS) in     patients with medically refractory epilepsy. A total of 15 subjects will be implanted at up     to three study sites.   "
243528|NCT01043419|"     The purpose of this study is to test the hypothesis that sympathetic neural outflow to     muscles as well as a sympathetic baroreflexes are not altered during xenon anesthesia in     Healthy Volunteers.   "
243529|NCT01043432|"     Those with traumatic brain injury (TBI) are at increased risk for suicidal behavior, and     suicidality is associated with executive dysfunction. In the aim of highlighting an important     risk factor, this study will assess decision making in the context of an interaction between     suicide and TBI. Findings will also allow for exploratory analyses aimed at identifying     associations between performance on measures of executive functioning and psychological     distress. The long-term objective of this study is to increase understanding regarding     executive dysfunction, as a multidimensional construct, with the ultimate goal of     conceptualizing assessment tools and interventions aimed at decreasing suicidality in the     at-risk population of veterans with a history of TBI.   "
243530|NCT01043445|"     The purpose of this study is to evaluate the impact of different ligands of GPR 119 (a G     protein-coupled receptor in the intestine) on the secretion of the incretin hormones, GLP-1     and GIP.   "
243531|NCT01043458|"     A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and     eliminated by the body of stable schizophrenic volunteers receiving treatment with an     atypical antipsychotic.   "
243532|NCT01043471|"     The purpose of this study is to determine if chewing gum increases energy expenditure and     decreases food intake.   "
243533|NCT01043484|"     The purpose of the study is to evaluate the efficacy and safety of the combination of     capecitabine + bevacizumab concomitantly with radiotherapy versus capecitabine concomitantly     with radiotherapy, as neoadjuvant treatment for patients with localized and resectable rectal     cancer.   "
243534|NCT01043510|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     investigate the pharmacodynamic (effect) and pharmacokinetic (exposure of drug) properties of     NN1250 (insulin degludec, IDeg) in subjects with type 2 diabetes of different race and/or     ethnicity.   "
243535|NCT01043523|"     Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging     agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than     18 years. Data that has been recorded in the child's medical records relating to the     injection of Primovist/Eovist will be collected. Information will be collected from up to 2     weeks before the child received Primovist/Eovist until 12 months after the child received     Primovist/Eovist. Copy of the child's MR images that were taken right before and after the     child received Primovist/Eovist and all other reports (laboratory reports, other imaging     reports, etc) that are part of the child's medical records during that time period will be     collected.   "
243536|NCT01043536|"     The main goal of this study is to evaluate and to determine the dose of a highly accurate     irradiation (allowing to increase the dose delivered while restricting the risk of     complication) in association with temozolomide.   "
243537|NCT01043549|"     Repetitive transcranial stimulation (rTMS) of the posterior parietal cortex will be applied     daily over five days in adult Gilles de la Tourette patients. This approach aims at reducing     premonitory sensations believed to induce tics. Patients will be randomized to an active or     placebo (sham) group in a crossover design.   "
243721|NCT01045889|"     The purpose of the study is to evaluate the efficacy of an intensified first-line treatment,     with conventional chemotherapy (CHOP) plus monoclonal antibody anti CD20, followed by high     dose chemotherapy and PBSC transplantation in HIV-related aggressive non-Hodgkin lymphoma at     high risk , according to the international prognostic index (IPI).   "
243542|NCT01043614|"     Project PEER utilizes a randomized controlled study design to investigate the combined     effects of an exercise and nutrition intervention that is based on self-efficacy principles     and delivered primarily by peer educators to reduce the risk for obesity in female college     freshman over one academic year (N = 300). The control group will receive minimal interaction     from the research team, paralleling the typical freshman experience on the UIUC campus.     Recruitment will take place in two waves (consecutive fall terms with n = 150).      During the final year (Fall 2010) of the project, a General Education course will be offered     that targets weight management. Importantly, the discussion groups for this course will be     taught by peer educators trained using the peer resources further refined during the PEER     project. In addition to conventional measures of content knowledge assessed in the college     classroom when obtaining class credit, personal physical activity and nutrition behaviors     along with behavioral determinants (self-efficacy, self-regulatory skills and outcome     expectations) will also be assessed.      Primary Aim 1: To determine the effectiveness of a peer-delivered self efficacy-based     behavioral intervention to enhance nutrition and physical activity behaviors and subsequently     weight management success in female university freshman over one academic year. We     hypothesize that freshmen randomized to the intervention group will be more successful in     losing or maintaining weight than the control group through a combination of diet and     physical activity strategies.      Primary Aim 2: To examine the role played by social cognitive factors in changing nutrition     and physical activity behaviors across one academic year. We hypothesize that self-efficacy     will have both a direct influence on behavior and an indirect effect through its influence on     self-regulatory skills and outcome expectations.   "
243543|NCT01043627|"     Assess tolerability, transition methods and clinical effects of transition from sildenafil     (Revatio) to tadalafil (Adcirca) for treatment of pulmonary arterial hypertension.   "
243544|NCT01043640|"     Rationale: Chemotherapy administration before a donor stem cell transplant is necessary to     stop the patient's immune system from rejecting the donor's stem cells. When healthy stem     cells from a donor are infused into the patient, the donor white blood cells can provide the     missing enzyme that causes the metabolic disease. Sometimes the transplanted cells from a     donor can make an immune response against the body's normal cells. Giving a monoclonal     antibody, alemtuzumab, before transplant and cyclosporine and mycophenolate mofetil before     and after transplant may stop this from happening. This may be an effective treatment for     inherited metabolic disorders.      Purpose: The design of this study is to achieve donor cell engraftment in patients with     standard-risk inherited metabolic diseases with limited peri-transplant morbidity and     mortality. This will be achieved through the administration of the chemotherapy regimen     described. The intention is to follow transplanted patient for years after transplant     monitoring them for complications of their disease and assisting families with a multifaceted     interdisciplinary approach.   "
243545|NCT01043653|"     In 2003 the VA Undersecretary's Action Agenda mandated that mental health services throughout     the system be transformed to a recovery model. That mandate and many of the Workgroup     recommendations have since been formalized in the Uniform Mental Health Services Package,     which specifies a range of recovery-oriented services that must be available to veterans. A     key aspect of these policy mandates is the need to assess recovery status of veterans and to     monitor their progress over time as a way to evaluate the effectiveness of recovery services.     However, there is no established instrument that is suitable for system-wide application. The     purpose of this project is to develop a reliable, valid and practical measure of recovery,     and use the measure in a study to better understand recovery in individuals with serious     mental illness.   "
243546|NCT01043666|"     This study is to assess the efficacy and safety of YM178 in patients with symptoms of     overactive bladder.   "
243547|NCT01043679|"     The goal of this research is to evaluate the safety as well as effectiveness of Utapine and     Seroquel in bipolar I disorder patients.   "
243548|NCT01043692|"     The aim is to investigate the feasibility and efficacy of an acupuncture intervention on     persistent MusculoSkeletar pain in a long-term geriatric hospital care ward population. The     main issue is the acceptability of this type of complementary and alternative medicine in     older people, although the efficacy on pain is assessed too.   "
243549|NCT01043705|"     The purpose of this study is to compare the incidence of cardiac implantable electronic     device (CIED) infection and CIED mechanical complication after CIED replacement with a     high-power cardiac implantable electronic device; either a cardiac resynchronization therapy     device (CRT), or an implantable cardioverter defibrilator (ICD) and TYRX Anti-Bacterial     Envelope (formerly known as AIGISRx), to the incidence, after replacement with an ICD or     CRT and no TYRX.   "
243550|NCT01043718|"     Hershey Medical Center and the University of Pittsburgh are doing a research study to help     meet the needs of the adult population at risk for diabetes and heart disease. This study     will provide a web-based program that aims to help participants to develop healthier eating     habits, lose weight and become more physically active. The Internet-based materials will     teach participants about healthy eating and physical activity and will ask them to     incorporate the information they learn into their daily lives.      The purpose of this study is to evaluate the effectiveness of online lifestyle change     programs to promote weight loss, healthy eating and physical activity patterns, in the     interest of reducing risk for and adverse outcomes of type 2 diabetes (T2D) and     cardiovascular disease (CVD).   "
243551|NCT01043731|"     Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the     clinical routine. Few authors have demonstrated the feasibility and safety of such procedures     (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the     experience with a transvaginal sigmoidectomy as a first in human report. The aim of this     prospective data collection is to evaluate the feasibility and safety of the transvaginal     hybrid anterior resection in the clinical routine.      Therefore all patients giving the informed consent to the transvaginal hybrid anterior     resection will be included and assessed concerning feasibility to perform the transvaginal     approach and complete the operation transvaginally.   "
243552|NCT01043744|"     To evaluate the causes of non-malarial febrile illness in children living in an area of     perennial malaria transmission and to determine if these children who test negative for     malaria by rapid diagnostic test receive any benefit from antimalarial therapy.   "
243567|NCT01043952|"     The objective of the study is to determine wether the use of the Bispectral Index Monitor     (BIS) as a method to guide anaesthesia for children in different groups of age, undergoing     ear nose and throat surgery anaesthetized with an infusion of Propofol and Remifentanil with     an high dose of Remifentanil (0,5-2 mcg/kg/min), can lead to a reduction in the time needed     for extubation and in the amount of anesthetics used.   "
243722|NCT01045902|"     The purpose of this trial is to determine the efficacy and safety of Moxifloxacin in     comparison to Sulbactam/Ampicillin in the treatment of pulmonary abscesses and aspiration     pneumonia.   "
243553|NCT01043757|"     Participants will be employees of Genzyme who volunteer to participate in a study on     motivating healthy behaviors, involving giving them goals for taking a certain number of     steps per day, and increasing that number over time. Participants will wear pedometers and     upload their data to a website that allows them to monitor their progress, and have the     opportunity to win money based on meeting their step goals.      Interested employees will schedule a day and time to complete a health screening at a Health     Fair at their place of employment, to ensure that they are healthy enough to participate; at     this time participants will also complete the investigators baseline dependent measures, and     receive a pedometer. After a one-week baseline period during which they wear the pedometer     and the investigators establish their typical number of steps per day, eligible participants     will then be assigned to one of four treatments - a no incentive control condition, and     three conditions in which they are entered into different kinds of monetary lotteries if they     have met their step goals for that day. Participants' initial goal will be based on their     steps during the baseline period, and the goal will increase by 250 steps each week, for a     total of 12 weeks. After these 3 months, the incentives portion of the experiment ends, but     participants continue to wear their pedometers and upload their data for an additional 6     months. At 3 months, 6 months, and then at the study end at 9 months, participants again     complete the investigators dependent measures at follow-up Health Fairs at their place of     employment.   "
243554|NCT01043770|"     The aim of our study is to see if people with metabolic syndrome who attend a group education     programme based on lifestyle changes (dietary and increased physical activity) can lessen     their risk of having diabetes, heart disease and strokes in the future.   "
243555|NCT01043783|"     The investigators ultimate goal is to test the hypothesis that immediate feedback of dietary     adherence will enhance compliance to a weight loss program. This study deals directly with     gathering the needed preliminary data for a grant submission.   "
243556|NCT01043796|"     The purpose of this study is to determine whether insecticide treated wall liners, in     combination with insecticide treated nets, reduce the incidence of malaria infections     compared to insecticide treated nets alone.   "
243557|NCT01043809|"     The purpose of this study is to assess whether simple, school-based handwashing promotion     impacts health and hygiene knowledge among students and their families.   "
243558|NCT01043822|"     The purpose of this study is to describe facial, behavioral and physiologic (heart rate)     reactivity of children with autism aged 3 to 6 years old, during a painful stimulation     (venepuncture). Children will be videotaped before, during and after a venepuncture. Each     recording will be rated with the FACS (Facial Action Coding System) and the NCCPC (Non     Communicating Children's Pain Checklist).   "
243559|NCT01043835|"     The purpose of this study is to compare the short- and long-term results between the     laparoscopy-assisted gastrectomy and the open gastrectomy.   "
243560|NCT01043848|"     Background: Although a small group, special attention has to be given to lower urinary tract     (LUT) dysfunctions in spinal cord injury (SCI) patients, as they also suffer under a loss of     motor-sensory function and autonomic regulation next to the severe deficiencies in bladder     and bowel control. Autonomic dysregulation linked with LUT dysfunction can cause autonomic     dysreflexia with life threatening increases in blood pressure and there is still no concept     for an early rehabilitation of bladder function after SCI.      Hypothesis: We assume that inadequate reorganization of nerve fibres in SCI is a reason for     spastic bladder dysfunction and vegetative dysregulation and that this can be positively     influenced by early neuromodulation. We hypothesized that bladder dysfunction as well as     autonomic dysreflexia will be positively affected.      Specific aims: Evaluation, if external pudendal nerve stimulation (EPS) can positively     influence LUT rehabilitation in SCI patients and if early initiation of stimulation is more     effective compared to late initiation (after spinal shock).      Experimental design: Prospective multicentre study in 36 SCI patients (24 treatment subjects,     12 control subjects). EPS will be started either within 10 days after SCI (early stim group)     or after cessation of spinal shock (late stim group). Effects on spastic bladder function and     autonomic disinhibition will be assessed by urodynamics, vegetative tests, and by     electrophysiological techniques.      Expected value: If early EPS is effective and complete SCI patients benefit from this     intervention; and if early onset of EPS has better and longer lasting effects than late onset     stimulation, the findings will be of utmost relevance not only for bladder function but also     to alleviate adverse phenomena such as autonomic dysreflexia. Neurostimulation may bear the     opportunity to early reshape maladaptive neuroplasticity. This would be proof of an effective     modulation and promotion of neuroplasticity, thus opening up new treatment options in the     field of paraplegiology.   "
243561|NCT01043874|"     To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on     study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in     chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or     later.   "
243562|NCT01043887|"     This study will evaluate the pharmacokinetics of ridaforolimus including the area under the     concentration-time curve (AUC[0-infinity]) and maximum concentration (Cmax) after     administration of a single dose of ridaforolimus in patients with moderate hepatic     insufficiency and healthy matched control subjects.   "
243563|NCT01043900|"     OCD is a chronic condition with a high rate of poor responders to conventional treatments,     such as antidepressants and psychotherapy. Chronic symptoms can lead to important social     impairment and suffering for patients and families.      The present study aims to investigate if the addition of transcranial magnetic stimulation     can provide enhanced response to conventional treatment.      Transcranial magnetic stimulation is a noninvasive technique that can influence specific     areas of the brain and has very few side effects.   "
243564|NCT01043913|"     The investigators hypothesize that Guaraná, a native plant from the Amazon, might improve     chemotherapy-induced fatigue in breast cancer patients undergoing treatment. In order to     assess this, the investigators randomized patients to either guaraná extract or to placebo,     switching the assigned treatment mid-term through the cycles of Chemotherapy.   "
243565|NCT01043926|"     This study will determine whether the plasma concentration-time profile and pharmacokinetics     (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are     similar to those observed in healthy participants.   "
243566|NCT01043939|"     Rationale: Survivors of childhood cancer are at an increased risk of developing     cardiovascular risk factors as well as early cardiovascular disease, likely due to the     intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich     source of flavonoids and a powerful antioxidant. Clinical studies in both diseased and     healthy adults suggest that daily consumption of PGJ contributes to increased antioxidant     capacity, reduced low-density lipoprotein (LDL) oxidation, and improved vasodilation.      Purpose: This randomized clinical trial is evaluating whether purple grape juice can reduce     oxidative stress and improve the vascular health of survivors of childhood cancer in the     early stages of cardiovascular disease.   "
243570|NCT01043991|"     Primary endpoint: Is intracoronary injection of a single dose of darbepoetin alpha, during     reperfusion in patients hospitalized for ST segment elevation myocardial infarction (STEMI),     able to reduce infarct size ?      In in vivo studies, many experiments evidenced infarct size reduction, due to anti-apoptotic     compounds, when given during reperfusion, after cardiac ischemia. In humans,     post-conditioning offers such a protection, as the investigators have previously showed     (Staat P et al. Post-conditioning the human heart. Circulation. 2005 112(14):2143-8).      Infarct size reduction could lead to a reduced rate of complications (heart failure, rhythmic     complications) and finally, morbidity and even mortality. This protection depends on     anti-apoptotic properties (Zhao ZQ et al. Inhibition of myocardial injury by ischemic     postconditioning during reperfusion: comparison with ischemic preconditioning. Am J     Physiology Heart Circ Physiology 2003 Aug; 285(2):H579-88). Many drugs have been proposed to     be able to mimic this phenomenon. Among them, many are efficient but toxic in vivo or     difficult to manage (insulin, morphin). One of the most promising agent could then be     erythropoietin (EPO) (Opie LH et al. Postconditioning for protection of the infarcting heart.     Lancet. 2006; 367(9509):456-8). In order to target ischemia-reperfusion injuries, EPO impact     is better and better demonstrated (e.g.: Mudalagiri NR. Erythropoietin protects the human     myocardium against hypoxia and reoxygenation injury via phosphatidylinositol-3 kinase and     ERK1-2 activation. Br J Pharmacol. 2007 Oct 22). The purpose of the study is to test this     hypothesis in humans, on the onset of the reperfusion, after myocardial ischemia (acute     myocardial infarct). EPO could contribute to protect myocardium against ischemia-reperfusion     injury. This impact could rely on anti-apoptotic properties.   "
243571|NCT01044004|"     To determine whether armodafinil is more effective than placebo in reducing fatigue.   "
243572|NCT01044017|"     This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose     concentration and other glycemic parameters of efficacy, and the safety and tolerability and     pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2.     On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of     RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is     <50.   "
243573|NCT01044030|"     The primary objective of the proposed study is to determine the effectiveness and safety of     orally administered viscous-adherent xylitol syrup given in a dose of five grams three times     daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear     infection) in children with a history of recurrent acute otitis media.   "
243574|NCT01044043|"     This is a 3 months single centre clinical patient-oriented study to evaluate the prevalence     and impairment in QOL of dermatologic diseases in patients hospitalised in internal medicine.      Up to 200 patients hospitalised at the division of internal medicine for any reason are going     to be offered participation by a patient information form given to patients at the time of     admission, as well as oral information about the study. Written informed consent will be     obtained by the investigators after patients have had adequate time to consider their     participation in the study.      Participating patients will be examined clinically for dermatologic pathologies at a single     visit. In the case of signs of dermatologic disease, investigators are going to recommend     further diagnostic procedures to the physician in charge and/or the referring physician,     depending on the urgency of the suspected diagnosis. This procedure is meant to avoid giving     referring physicians the impression that active patient acquisition for the department of     Dermatology is an aim of this study. Diagnostic procedures that are performed upon suspicion     of a specific dermatologic disease at the Division of Internal Medicine are going to be     performed during the hospitalisation period. All other diagnostic or operative procedures are     going to be advised to the referring physician.      Study participants are going to be interviewed by the investigators about impairment in QOL     of their illnesses. Two separate questionnaires are going to be filled in by each     participant. For measurement of general QOL, the widely used SF-12 questionnaire (8     questions) is going to be used. To measure specific impairment in QOL by dermatologic     disease, participants are going to be asked to fill in the DLQI (Dermatology life quality     index, 10 questions). Photographic documentation of specific identified lesions will be made     and pictures stored exclusively in the secured electronic patient file (KISIM). Medication     and all identified diseases will be noted. All diagnostically useful information is going to     be recorded in the patient file and transmitted to the referring physician in the discharge     letter.   "
243575|NCT01044056|"     An open-label, randomized, parallel group trial in healthy female subjects to compare the     pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and     an oral contraceptive (Microgynon® 30).   "
243576|NCT01044069|"     This study is an investigational approach that uses immune cells, called T cells, to kill     leukemia. These T cells are removed from blood, modified in a laboratory, and then put back     in the body. T cells fight infections and can also kill cancer cells in some cases. However,     right now T cells are unable to kill the cancer cells. For this reason we will put one gene     into the T cells that allows them to recognize and kill the leukemia cells. This gene will be     put in the T cells by a weakened virus. The gene will produce proteins in the T cells that     help the T cells recognize the leukemia cells and possibly kill them. The doctors have found     that T cells modified in this way can cure an ALL-like cancer in mice.      The main goals of this study is to determine the safety and appropriate dose of these     modified T cells in patients with ALL. This will be done in a clinical trial. The dose of     modified T-cells will depend on if you have disease present in your bone marrow or not. The     patient will also receive chemotherapy before the T cells. We will use normally chemotherapy     that is used in patients with leukemia. The chemotherapy is given to reduce leukemia and to     allow the T cells to live longer.   "
243577|NCT01044082|"     The primary purpose of the trial is to evaluate whether the management of placental delivery     with controlled cord traction (CCT) reduces the incidence of postpartum haemorrhage, compared     with management waiting for clinical signs of spontaneous placental separation, in women with     vaginal delivery receiving prophylactic oxytocin for the management of the third stage of     labour.      The hypothesis is that CCT, by reducing the length of the third stage of labour, facilitates     early postpartum uterine contraction and local haemostasis and decreases post partum blood     loss.   "
243578|NCT01044095|"     This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine     regimens in healthy volunteers using two commercially available seasonal influenza vaccines     to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be     spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral,     cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine     dose and compared with baseline values.   "
243579|NCT01044108|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the     trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but     otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up     period of up to 5 years.   "
243823|NCT01051180|"     Haemorrhoidal artery ligation operation (HALO) is an operation that ties off vessels to     piles. This study examines whether the ultrasound (doppler) is necessary to guide this tying     off or not.   "
243605|NCT01044446|"     The objective of the present study is to evaluate the a prior hypothesis that treatment with     icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis     complicating peritoneal dialysis. The safety and effectiveness of icodextrin for decreasing     glucose exposure, extent and severity of peritonitis will be evaluated in the setting of     acute peritonitis complicating peritoneal dialysis among patients who are not receiving     icodextrin.   "
243581|NCT01044134|"     Advice to increase water consumption as part of a weight-reducing diet - typically to 8 cups     (64 fl oz, ~2 L) per day (8x8 water recommendation) - is almost ubiquitously recommended by     healthcare professionals. Many believe that water promotes weight loss through numerous     physiological mechanisms. However, only limited observational data and virtually no     experimental data exist regarding the effects of water consumption on body weight. In this     study, we propose a randomized controlled pilot study in which two groups of overweight     adolescents will receive a standard weight loss regimen, either with (experimental     intervention) or without (control intervention) additional advice and support to increase     water consumption. We will utilize individual sessions, an innovative text messaging     protocol, and motivational telephone calls to promote adherence to the interventions. The     purpose of this pilot study is to evaluate feasibility and obtain preliminary efficacy data,     to inform design of a future, definitive study.      It is hypothesized that increasing water consumption will improve the efficacy of a standard     weight-reducing diet and will lead to decreased consumption of energy-containing beverages,     decreased total energy intake, improved diet quality, improved immune status, and improved     cardiovascular and diabetes risk factors. This simple behavioral intervention will be     feasible and will significantly increase water consumption among participants in the     experimental vs. control group.   "
243582|NCT01044147|"     With over half of the US population currently overweight and 31% of adults now obese, the     primary care setting may represent an important source of weight-loss support, in the     interest of cardiovascular prevention. Yet, although the US Preventive Services task force     recommends that physicians screen all adult patients for obesity and offer intensive     counseling and behavioral interventions to promote sustained weight loss for obese adults,     the recommendation has not been widely implemented. The Internet may help overcome many of     the barriers that have prevented intensive obesity counseling in the clinical setting. The     aim of this study is to examine whether Internet-based interventions for developing healthier     lifestyles can improve preventive health care in a cost-effective manner.   "
243583|NCT01044160|"     This proposal examines trauma and growth responses in the childhood cancer experience. It     addresses a number of gaps and unanswered questions in the literature, while integrating     several distinct but related lines of research. The rationale for this proposal is outlined     briefly as follows:        1. Traumatic stress models focused on pathology dominate pediatric psychosocial oncology          research despite empiric evidence of low levels of post-traumatic stress in this          population.        2. The assumption of 'cancer as a traumatic event' has biased research designs (including          lack of control comparisons) to focus on deficits and pathological outcomes.        3. This deficit-oriented approach has stimulated the development of interventions to treat          or prevent PTSD, which may be unnecessary or even harmful.        4. Theoretical and empiric evidence suggests that a more common response to traumatic          stress is growth and positive change, but posttraumatic growth phenomenon have been          understudied in pediatric populations.        5. Cognitive and personality factors are important determinants of PTSD and positive growth          outcomes, and some constructs from positive psychology theory may be particularly          relevant in children with cancer.        6. Empirically, parents of children with cancer appear to be at higher risk of PTSD/PTSS,          although results are not unequivocal, and the same research biases have applied to          parental outcomes. This proposal includes assessment of parental PTSS and PTG, both as          an outcome and a predictor of child outcomes.   "
243584|NCT01044173|"     At present, CT is the gold standard in the assessment of patients with acute abdomen. Yet,     one CT of the abdomen exposes patients to a radiation dose equivalent to several years of     background radiation. MR can be expected to yield the same information without ionizing     radiation, but tends to be more time consuming. In this study, patients with nontraumatic     acute abdominal pain referred to CT of the abdomen by the department of surgery will also     have performed an additional MR scan covering the entire abdomen with few fast imaging     sequences in approximately 15min. CT is the diagnostic test. The MR scan is only used for     scientific purposes. It will be evaluated by a radiologist blinded for the results of the CT     scan. Fourteen days after admission, a final diagnosis is established based on clinical,     peroperative, pathological and lab. findings. The performance of CT and MR will then be     compared. The investigators hypothesize that MR can provide a diagnostic accuracy comparable     to CT.   "
243585|NCT01044186|"     The purpose of this open-label, non-comparative, multi-center protocol was to further     evaluate safety and to provide treatment with ICL670 to patients who had or were at risk of     life threatening complications due to transfusional iron overload with a documented inability     to tolerate any of the commercially available iron chelators due to severe toxicity rendering     continued therapy either impossible or hazardous. Patients who were also ineligible for all     on-going registration trials with ICL670 were included in the study. In exceptional cases,     patients with a degree of iron overload which was not immediately life-threatening and who     were ineligible for the registration trials were also enrolled provided they had a     well-documented, sound justification for alternative chelation therapy.   "
243586|NCT01044199|"     The purpose of this study is to determine immunogenicity and safety of intradermal     administration of the PCEC rabies vaccine in adults.   "
243587|NCT01044212|"     The purpose of this study is to assess the effect of a standardized postoperative bowel     regimen of over-the-counter medications in subjects undergoing minimally invasive     urogynecologic surgery.   "
243603|NCT01044420|"     There are few studies about 2nd line treatment in advanced esophageal carcinoma(AEC), some     showed that irinotecan may be effective. The investigators previous study has shown the     efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study,     the investigators would like to observe the efficacy and safety of Irinotecan/5FU/leucovorin     as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.   "
243604|NCT01044433|"     RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving capecitabine together with lapatinib ditosylate may kill more     tumor cells.      PURPOSE: This phase II trial is studying how well giving capecitabine and lapatinib     ditosylate together works in treating patients with squamous cell cancer of the head and     neck.   "
243588|NCT01044225|"     The investigators propose to conduct a multicenter, open-label, randomized, phase II study in     patients with newly diagnosed glioblastoma (CeCil). Patients should meet all eligibility     criteria for the CENTRIC phase III trial at the exception that no MGMT-promoter methylation     could be demonstrated. The treatment backbone in both study arms will consist of     postoperative radiation therapy with concomitant daily temozolomide, followed by 6 cycles of     temozolomide according to a 21 out of 28 days regimen (as in the experimental arm of the RTOG     0525 / EORTC 26052-22053 phase III study). In study arm (A) Cilengitide (at a dose of 2000 mg     by iv administration, 2x/week) will be added to this backbone while in the second study arm     (B), Cetuximab will be added (at an initial dose of 400 mg/m² administered by intravenous     infusion over 2 hours and followed by a weekly dose of 250 mg/m² iv over 1 hours). In both     study arms, treatment will be administered for 52 consecutive treatment weeks. The 1-year     overall survival (1y-OS) following randomization will serve as the primary endpoint in both     study arms.   "
243589|NCT01044238|"     This 4-year study will investigate the effectiveness of methylphenidate for initiating and     sustaining abstinence in methamphetamine dependent individuals. Approximately 90 participants     seeking treatment for methamphetamine dependence will be enrolled in the study for an initial     2 weeks to establish clinic compliance. During this compliance phase, participants will     receive incentives for clinic attendance. After meeting clinic attendance requirements,     participants will be randomized to placebo (n = 45) or active study medication (n = 45)     conditions, and given 18mg/daily of study drug or placebo for one week, followed by     36mg/daily study drug/placebo for a second week. Finally, participants will be stabilized on     54mg/daily study drug/placebo for the remainder of the study. Placebo participants will be     given placebo medications prepared to appear identical to the active medication. In addition,     after randomization, all participants will receive motivational incentives for     methamphetamine-negative urine tests and begin weekly cognitive behavioral therapy (CBT)     provided for the duration of the study.   "
243590|NCT01044251|"     This study will analyze the effectiveness of a medication called Frovatriptan, in the context     of medication overuse headache (MOH). MOH is a headache that develops when pain-killers are     taken frequently. The treatment is to stop the overuse of these pain-killers, but that can     sometimes worsen the headache first before it gets better. We are testing Frovatriptan     against placebo to see if it can help patients with this transition and avoid the worsening     of the headache that can occur. We will also see if Frovatriptan can help in other ways, such     as maintain patients free of medication overuse.   "
243591|NCT01044264|"     A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study     conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical     Gel formulations.   "
243592|NCT01044277|"     This trial is designed to provide evidence of the efficacy of glutathione supplementation and     health(GSH) and includes the assessment of both short term and long term effects. Based on     previous laboratory animal studies and clinical data, the investigators anticipate that the     effects of oral GSH supplementation will be progressive and cumulative. The study will also     allow for the evaluation of effects of withdrawal of the supplement on the outcome variables.   "
243593|NCT01044290|"     The purpose of this study is to determine whether discussions of life story, forgiveness, and     future goals improve quality of life for patients with serious illness.   "
243594|NCT01044303|"     The purpose of this study is to demonstrate that increased dosages of mycophenolic acid in     maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies.   "
243595|NCT01044316|"     This study will evaluate the safety and efficacy of two doses of two commercially available     vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of     age.   "
243596|NCT01044329|"     This randomized clinical trial is conducted to evaluate the effect of three intravitreal     injections of bevasizumab versus two intravitreal injections of triamcinolone in acute     retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The     follow-up time is 6 months.   "
243597|NCT01044342|"     The purpose of this study is to determine if cognitive impairment induced by scopolamine is     reversed using donepezil and/or AZD1446 as compared to placebo, as assessed by     electroencephalogram (EEG) measures.   "
243598|NCT01044355|"     The primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison     to APAP in reducing arterial blood pressure in patients with resistant hypertension and     obstructive sleep apnea (OSA).      The secondary objectives are: a) to evaluate the relative effectiveness of fixed CPAP versus     APAP in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory     markers and glucose regulation; b) to identify specific characteristic of persons who respond     to the two CPAP modalities in order to identify which device is better for each subject.   "
243599|NCT01044368|"     This project will test the effectiveness of an Internet based glucose monitoring system on     the A1C levels of patients with type 2 diabetes. All of the patients are given a meter and     test strips to test their blood glucose levels, however, half of them will be required to     also upload their meter onto the Internet which can then be viewed by their endocrinologist.     The doctor can then send a message back to the patient and comment on the readings. The     effect of the ongoing communication will be measured by the changes in the glucose levels     (HbA1C) over 3 and 6 months.   "
243600|NCT01044381|"     To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole     after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting     in adults with distal subungual onychomycosis of the toenails.   "
243601|NCT01044394|"     We seek to evaluate whether a same day, reduced liquid volume (2liters) polyethylene glycol     (PEG-ELS) bowel preparation can achieve adequate colon cleansing in patients scheduled for     afternoon colonoscopies. The primary outcome will be adequacy of the bowel preparation.     Secondary outcomes will include Boston Bowel Preparation Scale score, patient compliance with     completing the preparation, tolerability of the preparation, willingness to repeat the     preparation, side effects, duration of procedure (endoscope insertion and withdrawal times),     and polyp detection.   "
243602|NCT01044407|"     To evaluate whether cardiac output manipulation via a cardiac pacemaker can stabilise     ventilation.   "
243606|NCT01044459|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled     aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic     obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in     period, a 52-week treatment period and a 2-week follow up phone call. All patients will be     randomized to one of two doses of aclidinium bromide.   "
243607|NCT01044472|"     The purpose of this clinical investigation is to evaluate the safety and hemodynamic     performance of the MSLV Pacing feature in a clinical setting.   "
243608|NCT01044485|"     The objective of this phase I/ II study is therefore to assess the safety and efficacy of     lapatinib in combination with docetaxel in patients with advanced cancer. Only patients in     first line treatment for metastatic disease should be included in the present study. It is     proposed to start with a phase I part evaluating the safety of lapatinib 1250 mg with     docetaxel 75 mg/m² without systematic support of growth factors, starting after the     completion and data from the 1000 mg lapatinib +75 mg/m² docetaxel dose level in the EORTC     (Bonnefoi) study.The objective of the phase II part will confirm the safety and evaluate     efficacy of lapatinib in combination with docetaxel.   "
243609|NCT01044498|"     This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on     the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female     patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child     bearing age. The RA patients received OC in combination with TCZ, whereas the healthy     volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8     mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The     healthy volunteers received OC for only one 21-day cycle.   "
243610|NCT01044511|"     The aim of this study is to compare, specialist nurse home visits in patients with inoperable     cancer in the esophagus or cardia, who are palliated with Self Expanding Metal Stent, to     standard patient contact with regards to quality of life, number and character of     reinterventions and cost-effectiveness.   "
243611|NCT01044524|"     This study will investigate the absorption, distribution, metabolism and excretion after     giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be     determined.   "
243612|NCT01044537|"     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and     pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with     Type 2 Diabetes Mellitus (T2DM).   "
243613|NCT01044550|"     Title: A randomized prospective study comparing non operative management with laparoscopic     treatment in patients with a diaphragm injury following left thoracoabdominal stab wounds.      Aim of the Study: The aim of this study is to access the clinical outcome of potential occult     diaphragm injuries in a group of patients presenting at the Groote Schuur trauma centre with     left sided thoracoabdominal stab wounds, if an expectant non operative management course is     taken.      Objects of the Study: To obtain the above mentioned aim the study will undertake;        -  to do laparoscopy on a group of randomly selected patients with left thoracoabdominal          stab wounds to obtain the incidence of occult diaphragm injury.        -  to assess the incidence and clinical outcome of delayed diaphragm visceral herniation in          the study group.   "
243614|NCT01044563|"     The specific aims of this study are:        1. To develop a breathing training protocol specifically designed to improve HRV and          psychosocial functioning for postmenopausal women with depressive symptoms,        2. To examine the immediate effects of an 8-week breathing training program on HRV and          psychosocial end points in postmenopausal women with depressive symptoms,        3. To examine the intermediate-term effects of an 8-week breathing training program on HRV          and psychosocial end points in postmenopausal women with depressive symptoms, and        4. To determine whether the change in depressive symptoms with breathing training in          postmenopausal women is associated with the change in HRV.   "
243615|NCT01044576|"     The primary goal of the research cohort is to facilitate patient access to clinical trials     testing new therapeutic interventions, or access to second- line treatments.      Secondary objectives of the research cohort study are to obtain detailed clinical phenotyping     and immunological analysis of blood samples, aiming to identify and validate biomarkers of     disease activity and response to treatment and prognostic markers.   "
243616|NCT01044589|"     The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to     reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in     controlling episodes of incontinence in patients who have fecal incontinence and a defect in     the anal sphincter.   "
243617|NCT01044602|"     Best medical management and gastric bypass surgery is a way to treat diabetes as part of     regular medical care (standard of care). However, gastric bypass surgery is not a way to     treat diabetes as part of regular medical care (standard of care).   "
243618|NCT01044615|"     We will utilize a set of imaging modalities including computed tomography (CT), positron     emission tomography (PET), and a suite of magnetic resonance imaging (MRI) tools, to     investigate the changes in the human brain resulting from mild traumatic brain injury (mTBI).   "
243619|NCT01044628|"     Background: Long-term oxygen therapy (LTOT) is the only component of the management of     chronic obstructive pulmonary disease (COPD) that improves survival in patients with severe     daytime hypoxemia (defined as an arterial oxygen pressure [paO2] measured in stable state     <=55 mmHg or in the range 56-59 mmHg when clinical evidence of pulmonary hypertension or     polycythemia are noted). In Canada, LTOT is usually provided by a stationary oxygen     concentrator and is recommended to be used for at least 15-18 hours a day. Several studies     have demonstrated a deterioration in arterial blood gas pressures and oxygen saturation     during sleep in patients with COPD. Sleep-related oxygen desaturation often occurs in     patients not qualifying for LTOT. The suggestion has been made that the natural progression     of COPD to its end stages of chronic pulmonary hypertension, severe hypoxemia, right heart     failure, and death is dependent upon the severity of desaturation occurring during sleep.     This is an attractive hypothesis and is supported by the fact that hypoxemic episodes during     sleep are accompanied by substantial increases in pulmonary arterial pressure and often by     important cardiac arrhythmias. Supplemental nocturnal oxygen alleviates both the acute     increases in pulmonary arterial pressure and the cardiac arrhythmias. It has been suggested     that, over the long run, nocturnal oxygen therapy (N-O2) may halt the progression of     long-standing cor pulmonale and prolong survival. Probably due to the fact that the     recommendations of scientific societies regarding the indications for and use of N-O2 in COPD     not qualifying for conventional LTOT are presently imprecise, a number of patients are     currently treated with N-O2 although the beneficial effects of this therapy have not been     confirmed.      Objectives:      Primary objective: To determine, in patients with COPD not qualifying for LTOT but who     present significant nocturnal arterial oxygen desaturation, whether N-O2 provided for a     period of 3 years decreases mortality or delay the prescription of LTOT.      Secondary objectives: To estimate, in the same population, the cost-utility ratio of     nocturnal oxygen therapy over a 3-year period.      Hypotheses: In patients with COPD not qualifying for LTOT but who present significant     nocturnal arterial oxygen desaturation, N-O2 provided for a period of 3 years is effective in     decreasing mortality or delaying the requirement for LTOT; and is cost-effective and     favorably compares to other medical interventions.      Research plan:      Study design: We propose a 3-year, multi-center, placebo-controlled, randomized trial of     nocturnal oxygen therapy added to usual care in patients presenting sleep-related oxygen     desaturation who do not qualify for LTOT.      Inclusion criteria: (1) patients with a diagnosis of COPD supported by an history of past     smoking and obstructive disease with FEV1/FVC < 70%; (2) a saturation at rest < 95% ; (3)     patients fulfilling our definition of nocturnal oxygen desaturation: >=30% of the recording     time with transcutaneous arterial oxygen saturation <90% on at least one of two consecutive     recordings.      Intervention: nocturnal oxygen therapy: N-O2 will be delivered overnight to allow the oxygen     saturation to be >90%.      Placebo: The patients allocated in the control group will receive room air delivered by     defective concentrator. The comparison will be double blind.      Primary outcomes: The primary outcomes of this trial are mortality from all cause or     requirement for LTOT (composite outcome).      Secondary outcomes: Secondary outcomes will include quality of life and utility measures,     costs from a societal perspective and compliance with oxygen therapy.      Trial duration: The follow-up period lasts at least 3 years. We expect this trial to be     completed within 5 years.      Sample size calculation: The sample size should give 90% chance of showing a 30% relative     reduction in event rates between the two study groups (i.e., an event rate in the     intervention and placebo groups of 28% and 40% respectively). We calculated that 300 patients     per group are needed to complete this study (630 to account for potential withdrawal).   "
243620|NCT01044641|"     The purpose of this study is to identify normal values of colloid osmotic pressure in     interstitial fluid and plasma in healthy children between 2 and 10 years.   "
243621|NCT01044654|"     This research study is being carried out to study a new way to possibly treat HIV. This agent     is called a Zinc Finger Nuclease or ZFN for short. ZFNs are proteins that can delete     another protein named CCR5. This CCR5 protein is required for certain types of HIV (CCR5     tropic) to enter into and infect your T-cells. T cells are one of the white blood cells used     by the body to fight HIV. The most important of these are called CD4 T-cells.      Some People are born without CCR5 on their T-cells. These people remain healthy and are     resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and     their HIV disease is less severe and is slower to cause disease (AIDS).      Even with no detectable levels of HIV in the blood, HIV remains in some tissues in the body,     primarily the gut tissue. HIV infects the CD4+ T-cells including in the blood and gut. The     new treatment to be studied will involve removing white blood cell from the blood that     contains CD4+ T-cells. The extracted CD4+ T-cells are then genetically modified by the ZFNs     to be resistant to infection by HIV by removing the CCR5 gene from the surface of the CD4+ T     cell where HIV enters the cell. Additional genetically modified cells are manufactured and     then re-infused back into you. Researchers hope that these genetically modified cells will be     resistant to infection by HIV and will be able to reproduce additional resistant CD4+ T-cells     in your body.      Laboratory studies have shown that when CD4+ T-cells are modified with ZFNs, HIV is prevented     from killing the CD4+ T-cells. On the basis of these laboratory results, thre is the     potential that ZFNs may work in humans infected with HIV and improve their immune system by     allowing their CD4+ T-cells to survive longer.      The purpose of this research study is to find out whether zinc finger modified CD4+ T-cells     are safe to give to humans and find how zinc finger modified T-cell affects HIV.   "
243622|NCT01044667|"     The primary objective of this study is to evaluate gastrointestinal (GI) symptoms and health     related quality of life in lung transplant recipients converted from Mycophenolate Mofetil     (MMF) to Myfortic as part of standard immunosuppressive therapy.   "
243623|NCT01044680|"     The purpose of this study was to determine the effects of NUTRIOSE® supplementation on body     composition, satiety, and determinants of metabolic syndrome in overweight men.   "
243624|NCT01044693|"     The purpose of this study is to evaluate the effect of the antihypertensive drug, nebivolol     (Bystolic), compared to metoprolol (Lopressor) and sildenafil (Viagra) on blood pressure in     patients with autonomic failure and supine hypertension.   "
243625|NCT01044706|"     The objective of this study is to compare the rate and extent of absorption of bicalutamide     50 mg tablet (test) versus Casodex® (reference), administered as 1 x 50 mg tablet under fed     conditions.   "
243626|NCT01044719|"     Cystic Fibrosis patients attending with infective exacerbations will be enrolled into the     study. The trial is a double blinded, randomised trial with patients randomised to 10,14 or     21 days of antibiotic therapy, comprising of tobramycin and either ceftazidime or meropenem.   "
243627|NCT01044732|"     The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of     a standard colonoscope to provide an additional, retrograde (or backward) view that reveals     areas behind folds and flexures in the colon, and might detect additional polyps that cannot     be seen with the colonoscope alone.      Patients who participate as subjects in the study will undergo two complete colonoscopy     procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used     along with the same colonoscope. Half of the patients will have the standard colonoscopy     first followed by the Third Eye colonoscopy, and the other half will have the Third Eye     procedure first.      Results from the two groups will be analyzed and compared to determine the effectiveness of     the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the     standard colonoscope alone.   "
243628|NCT01044745|"     This phase II trial is studying how well rituximab works in preventing acute     graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for     hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell     transplant helps stop the growth of cancer cells. It may also stop the patient's immune     system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor     effect). Sometimes the transplanted cells from a donor can also make an immune response     against the body's normal cells. Giving a monoclonal antibody, rituximab, together with     anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the     transplant may stop this from happening   "
243629|NCT01044758|"     This research is being done to find out if daily use of the drug levetiracetam can improve     memory function in individuals with memory problems like those associated with Mild Cognitive     Impairment (MCI) and Alzheimer's disease (AD).   "
243630|NCT01044771|"     The study is designed to evaluate the proportion of patients with tenofovir induced     proteinuria that will resolve their proteinuria when the tenofovir containing     nucleoside/nucleotide backbone is switched to a raltegravir backbone. Common HIV treatment     regimens contain nucleoside/nucleotide combinations that may have long-term side effects     including nephrotoxicity. Switching these backbones out for an integrase inhibitor based     regimen has not been systematically evaluated.      Hypothesis: Proteinuria developing during treatment with tenofovir improves or resolves when     tenofovir is switched out with raltegravir. Switching to a nuc- sparing regimen, containing     raltegravir and a boosted protease inhibitor in patients without preexisting protease     inhibitor mutations is safe and does not lead to virologic failure   "
243631|NCT01044784|"     The purpose of this study is to evaluate the effects of various LV-LV delays during     multi-site left ventricular (MSLV) pacing on mechanical dyssynchrony in cardiac     resynchronization therapy (CRT) patients post-implant.   "
243632|NCT01044797|"     The purpose of the study is to learn about the feasibility of moving a pill-sized camera     (Givens Capsule) remotely in the esophagus and stomach using an external hand held magnet.   "
243633|NCT01044810|"     The primary objective of this study is to compare the effectiveness of EFV-based regimens in     HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV     simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a     period of time, i.e. staggered interruption; and (3) started EFV-based regimens as an     initial regimen (as controlled group).   "
243634|NCT01044823|"     One of the biggest challenges in caring for patients with Rheumatoid Arthritis (RA) and     Juvenile Rheumatoid Arthritis (JRA) is quantifying the degree of disease activity in any     given joint. We have built a prototype device using well-established sensors to rapidly     quantify surface swelling and heat in arthritic joints. The goal of our studies is to test     the hypothesis that this Imager can improve the clinical assessment of arthritis.   "
243635|NCT01044836|"     The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203     with those of etanercept after subcutaneous injection in healthy male volunteers.   "
243636|NCT01044849|"     Blood pressure meter model CH-609 was to be assessed against the standard mercury     sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.   "
243637|NCT01044862|"     The objective of this application is to identify a pharmacologic agent which helps couples in     whom the female partner ovulates regularly successfully obtain their goal of delivering a     healthy child, whose use will result in low rates of multiple gestations. The central     hypothesis is that, in infertile ovulatory women undergoing ovarian stimulation (OS) and     intrauterine insemination (IUI), the use of aromatase inhibitors (AI) will stimulate the     ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly     reducing the numbers of multiple gestational pregnancies that result from stimulation with     clomiphene citrate (CC) or follicle stimulating hormone (FSH). The rationale for the proposed     research is that reduction of multiple pregnancy rates could significantly reduce maternal     and neonatal morbidity and mortality, as well as the cost of healthcare for these individuals     and society.   "
243708|NCT01045720|"     The goal of this research is hoping to combine traditional Chinese medicine medication and     find out how to solve clozapine-induced hypersalivation, also reduce side-effect, medication     compliance, improving life quality, improving social-function and reducing neopathy.   "
243638|NCT01044875|"     The purpose of this study is to measure effectiveness of yellow 577 nm laser compared to     conventional green laser 532 nm for diabetic retinopathy in terms of number of treatment     sessions required and visual acuity outcome.      The study also compares pain score of patients receiving laser treatment and side effects of     laser treatment.   "
243639|NCT01044888|"     The investigators evaluated clinical impact of reduced heparin responsiveness (HRreduced) on     the incidence of perioperative myocardial infarction (MI) and restenosis at 6 months after     off-pump coronary artery bypass graft surgery (OPCAB) and identified its predictors.   "
243640|NCT01044901|"     In this research study, we are using heart imaging exams and blood testing, in order to gain     an improved understanding of the pulmonary (lung) hypertension and cardiovascular (heart)     complications that often occur in sickle cell patients. Information gathered from the healthy     volunteers that participate in this study will be compared to information from the sickle     cell patients in this study in order to help further our understanding.   "
243641|NCT01044914|"     Pharmacological treatment of schizophrenia is still characterized by a certain proportion of     patients who are resistant to common antipsychotics. Variability in individual response     ranges from patients who experience complete or near complete symptom remission to a subset     of patients who remain treatment-refractory despite extensive drug trials over years. The     investigators propose to take advantage of the simultaneous acquisition of clinical and of     intermediate phenotypes to ascertain the possible contribution of SNPs within putative     causative genes to response to treatment with quetiapine XR.   "
243642|NCT01044927|"     Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death in the United     States, affects 24 million people and is responsible for up to $32 billion annually in direct     and indirect health care costs. Based upon these national COPD prevalence data, we estimate     that 483,000 Coloradans have COPD (193,000 diagnosed and 290,000 undiagnosed), and that the     care of these patients costs up to $490 million annually. Therefore, to alter the impact of     COPD on the State and People of Colorado, we propose to introduce a telephone-dependent,     internet-supported, self-monitoring eHealth management system in both urban and rural     Colorado settings in order to decrease healthcare utilization, improve the management of COPD     based upon current national guidelines, improve quality of life, reduce health care costs     decrease COPD exacerbations. We base this program on a successful clinical pilot study,     performed at the University of Colorado Hospital (UCH) during 2004-2005, which demonstrated     dramatic improvements in quality of life and decreased health care costs. We propose to     enroll patients with advanced COPD, or a history of COPD exacerbations, because these are the     patients with the highest healthcare costs, the greatest disability, and the highest     mortality. The ultimate goal of this project is to demonstrate the feasibility and efficacy     of this proactive management strategy as it is disseminated throughout urban and rural     Colorado. In this first phase we will target two Denver Metro sites, UCH and     Kaiser-Permanente (KP), and rural sites (to be determined). We chose these urban sites     because of their strong interest in enacting the eHealth Program, because of their organized     systems of healthcare delivery and because of the numbers of COPD patients that they serve.     We are particularly enthusiastic about the application of this technology to rural,     underserved areas, because this approach has the potential to dramatically improve delivery     of healthcare to a large portion of Colorado that is chronically plagued by inadequate health     care networks and lack of specialty care. More broadly, we are enthusiastic about the     prospect that eHealth programs may hold the potential to improve healthcare delivery for many     chronic illnesses, in addition to COPD.   "
243643|NCT01044940|"     The purpose of this study is to measure colloid osmotic pressure in interstitial fluid and     plasma in healthy children under two years, in asphyxiated babies and in children undergoing     heart surgery.   "
243644|NCT01044953|"     The winter break within the German Professional Football Leagues will be shortened as for the     season 2009/2010 from 6.5 to 3.5 weeks. That might have repercussions on injury incidence in     either way, positive or negative. On the one hand, recovery time during the winter will be     shorter, which might lead to an increased risk of injury. On the other hand, it will allow a     better spread of games in the second round, thus reducing the amount of the so-called     English weeks, which in turn could reduce the number of injuries. This study compares     injury incidence between the season 2008/2009 (long winter break) and the season     2009/2010(short winter break) via questionnaires in accordance with UEFA/FIFA injury     evaluation criteria.   "
243645|NCT01044966|"     Current treatments for Glioblastoma Multiforme (GBM), the most common and malignant primary     brain tumor are inadequate and as such, the median survival for most patients with GBM is on     the order of months, even after cytoreductive surgery, radiation and chemotherapy. This study     aims to develop a new treatment for GBM by suppressing glial progenitor cells that surround     the ventricular system in patients with these aggressive tumors because it is these regions     that appear to act as an incubator for future recurrences resulting in patient death.     Considering the lack of significant treatment options for patients with this uniformly fatal     disease, this is an important translational clinical study to perform.   "
243646|NCT01044979|"     The purpose of this study is to evaluate a method of sampling interstitial fluid from     subcutaneous sewn wicks.   "
243647|NCT01044992|"     Background: Multiple System Atrophy (MSA) is an atypical parkinsonian syndrome including     cerebellar impairment and poor response to dopatherapy. The objective of the study is to     assess right-hand motor activation in MSA patients before and after an acute levodopa     challenge and to compare these data with those obtained in patients with Parkinson Disease     (PD) and healthy volunteers (HV).      Methods: Eighteen MSA patients, eight PD patients and 10 age-matched HV will be included.     rCBF measurements with H215O PET will be performed at rest and during a right hand movement.     Statistical parametric mapping will be used to analyze motor versus rest in OFF and ON     condition and effect of levodopa on motor activation.      Hypothesis: MSA and PD patient should recruited different motor networks.   "
243723|NCT01045915|"     The objective of the present trial is to evaluate the local and general safety of the     intratumoural electrotransfer of increasing doses of Plasmid AMEP in patients suffering from     advanced or metastatic melanoma and to identify doses that could be effective on cutaneous     lesions in man.   "
243648|NCT01045005|"     The investigators aim to show that quantitative analysis of doppler flow velocity waveforms     i.e. ultrasound which is a non−invasive and very safe means of assessing blood flow; recorded     in the proximity of terminal microvascular beds of interest, (i.e. the forearm and ocular     circulation) can sensitively detect and track local changes in microvascular haemodynamics     i.e. the function of the small blood vessels that are found in the back of the eye and in the     forearm.      The investigators also aim to relate change in the doppler spectral flow velocity waveform     i.e. the ultrasound signal, in the central retinal artery to changes in geometry and tone of     the vasculature (or changes in the structure and function of small blood vessels) in response     to inhaled oxygen and carbon dioxide. The geometry and tone of the vasculature (or Blood     Vessels) can be measured by taking photographs of the back of the eye.   "
243649|NCT01045018|"     The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were:        -  To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and          Asacol Delayed Release Tablets 2.4 g per day (800 mg three times daily) and        -  To evaluate the safety of MDRT 2.4 g per day (800 mg three times daily) compared to          placebo.   "
243650|NCT01045031|"     There is substantial research on the effects of physical exercise on cognitive functions.     However, less attention has been paid on the requirements of training intensity and length to     enhance cognitive abilities in the elderly. To the investigators knowledge no studies have     evaluated the effects of extensive endurance exercise training on cognitive functions by     studying elderly marathon runners and bicyclists. On the basis of the scientific literature     published so far it is not known whether the beneficial impact of endurance exercise training     depends on the intensity of training.      The investigators therefore designed a cohort study with adequate power in order to evaluate     the effects of intensive endurance exercise training on cognition. This trial, an Austrian     prospective cohort study in cognitive function of elderly marathon-runners (APSOEM) is being     conducted and will compare neuropsychological performance outcomes of elderly marathon     runners or bicyclists with controls matched concerning age, education years, occupation, and     verbal intelligence.   "
243651|NCT01045044|"     We will use magnetic resonance imaging (MRI) to investigate tumor changes in women with     breast cancer who are receiving anthracycline-based systemic chemotherapy. We will also use     MRI and cognitive tests to study the possible effects of chemotherapy on the brains of these     women. The results will be compared to a control group of normal healthy women. We will try     to determine if MRI can be used to predict tumor response and cognitive changes related to     the chemotherapy.   "
243652|NCT01045057|"     During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice     prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During     this study a new surgical tool will be investigated that creates the puncture and places the     voice prosthesis.   "
243653|NCT01045070|"     Atherosclerosis is an inflammatory disease. The hypothesis of an infectious burden as     trigger or initiator of the inflammatory process in atherosclerosis has been extensively     discussed in the past years. One part of this discussion is focused on the infectious agents     responsible for periodontitis. Several studies have found an association of periodontitis     and/or bacteria related to this disease and atherosclerosis. However, a study focussing on     the prognostic relevance of these factors is missing.      The hypothesis of this study is that periodontitis is a prognostic relevant risk factor for     patients with angiographically proven coronary heart disease. Furthermore, the infectious     pathogen burden by PCR-detection of periodontal pathogens will be evaluated as a prognostic     factor.      960 consecutive patients with angiographically proven coronary heart disease will be included     in this study. After inclusion of patients an extensive periodontal examination including     PCR-sampling for 11 bacteria (Porphyromonas gingivitis, Actinobacillus actinomycetemcomitans,     and others) will be performed. After 12 months patient will be follow up for any major     adverse events (cardiovascular death, myocardial infarction, stroke).      If this study will find a relation of periodontitis or its microbiological agents to     cardiovascular outcome of patients with coronary heart disease, further studies are necessary     to investigate potential therapeutic consequences for patients with CHD and periodontitis.   "
243654|NCT01045083|"     This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to     characterize the response to three centrally active drugs and placebo.   "
243655|NCT01045096|"     The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole,     once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.   "
243656|NCT01045109|"     This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum     prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade,     low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10;     clinical stage T1C or T2a), who elect to have their disease monitored through active     surveillance for at least one year.   "
243664|NCT01045213|"     Integrated eHealth is an innovative, proactive approach to the management of patients with     chronic cardiopulmonary disease. Our overall goal is to improve the health of patients by     integrating guideline-based education, remote disease monitoring, coordinator-based disease     management and healthcare provider-initiated therapy. Patients enrolled in the program     receive a set of equipment, including a Health Buddy® telemonitor that connects to a normal     telephone, as well as instruments to measure oxygen levels (pulse oximeter), lung function     (spirometer) and activity (pedometer). Through the Health Buddy® patients receive     guideline-based disease education in their own homes. The Health Buddy® also allows patients     to transmit daily information about their symptoms, oxygen levels, lung function and ability     to walk to program coordinators located at the University of Colorado Hospital. Our program     coordinators are highly experienced nurses or respiratory therapists with expertise in the     management of chronic obstructive pulmonary disease (COPD) and congestive heart failure     (CHF). Through this remote disease education/monitoring program, patients learn to take a     more active role in the management of their own disease. However, once the coordinators     identify early warning signs of a potential problem, patients are contacted and connected to     their primary healthcare provider for early intervention. By this integrated approach to     care, patients learn self-management techniques, physician communication is enhanced, and     early interventions for problems are possible. We propose to target the Integrated eHealth     Program to areas of Colorado that are highly impacted by COPD.      Key Objectives: The key objectives are to improve COPD care in the 16 Colorado counties with     high COPD mortality rates.      Target Population: We will target patients with severe or very severe COPD.      Expected Outcomes: We expect that this study will increase the use of evidence-based     guidelines in the screening, diagnosis and treatment of COPD, resulting in improved     quality-of-life and a reduction in healthcare utilization.   "
243665|NCT01045226|"     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating     patients with prostate cancer.   "
243682|NCT01045447|"     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).      The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with     insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and     oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the     trial.   "
243709|NCT01045733|"     The purpose of this study was to evaluate and compare postoperative corneal aberrations and     visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular     lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.   "
243710|NCT01045746|"     The goal of this pilot study is to test whether in the elderly population there are acute     long-term improvements in both the static and dynamic balance, reaction time and mobility     with the use of WBV.   "
243657|NCT01045122|"     Overview of Protocol:      Between Subject - Repeated Measures design will be used to assess the airway response of two     groups of subjects under two different sedated conditions. Each group will be comprised of     six subjects and will be categorized according to their baseline profile for risk for SDB (<     10 RDI or > 25 RDI). Some subjects will have been prescribed continuous positive airway     pressure (CPAP) therapy by their treating physician as a result of their overnight sleep     study. CPAP treatment is effective in splinting the airway open and thus decreasing the     incident of airway collapse during sleep. Thus, CPAP utilization will also be tracked as an     independent and continuous variable as regular CPAP use has been found to be associated with     increased resistance to UAC (upper airway collapse).      The experimental conditions will evaluate upper airway patency and instability in response to     two forms of intravenous sedation: propofol and dexmedetomidine.      Subjects will be continuously monitored during each experimental condition for respiratory     effort and flow, and for EEG, EMG, and ECG.      Respiratory instability will first be assessed while subjects are under sedation without any     airway provocation. The degree of respiratory instability will be quantified in terms of the     following measurements: a modified Respiratory Disturbance Index (RDIsedated), respiratory     arousals, and minute ventilation. The apneic periods will be classified by their mixture of     central and obstructive components.All outcome measurements are assessed over the period of     sedation which last for approximately one hour.      Upper airway patency will be quantified in terms of the critical pharyngeal pressure (Pcrit)     (the pressure beyond which complete upper airway collapse occurs, see background).   "
243658|NCT01045135|"     Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to     urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%),     sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries     are not easy to diagnose as they are not visible when looking at surface anatomy during a     standard gynaecological examination. The investigators are therefore in urgent need of better     tools to diagnose these injuries. Having a reliable and easily accessible tool enables     studies of the consequences of such pelvic floor muscle injuries. It also makes it possible     for us to explore the effect of interventions such as pelvic floor muscle training and     surgery in patients with and without pelvic floor muscle injuries. The investigators have     previously presented data to support the reliability and the validity of the three and four     dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in     healthy volunteers and have now a tool to study women before and after delivery. At the     Department of Obstetrics and Gynaecology, Akershus University Hospital there are     approximately 4500 deliveries annually and 1500 women are giving birth for the first time.      Challenges: The invitation to participate in the study will be given to all women expecting     their first child fulfilling inclusion criteria. The biggest challenges in the project will     be logistical. To be able to inform, recruit and follow women having their first child is a     challenge in it self.      Applications: If it is possible to identify a risk group for pelvic floor injuries before     delivery, it might be ethical to recommend a prophylactic caesarean section to avoid     disabling incontinence and prolapse later in life.   "
243659|NCT01045148|"     Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and     efficacy compared with actual prostate HDR treatment, but does it without the catheters and     hospital admission. As such, it is a more patient friendly treatment method compared with     actual prostate HDR brachytherapy as currently practiced. Related, as has previously been     reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should     have a high efficacy but with lower acute and chronic morbidity compared with other local     prostate cancer treatment methods such as permanent seed prostate brachytherapy.   "
243660|NCT01045161|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium     bromide doses compared with placebo in the treatment of moderate to severe, stable chronic     obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period     followed by a 12-week double-blind, placebo-controlled treatment period. This will be     followed by an open-label 40-week treatment period and a 2-week follow up phone call. All     patients will receive the higher Aclidinium Bromide during the 40-week open label treatment     period.   "
243661|NCT01045174|"     A Breath-Actuated Nebulizer is a newer type of nebulizer device that creates aerosol only     when a patient is inhaling, rather than creating aerosol continuously. It is thought that     breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs     more effectively and therefore lead them to recover from asthma attacks faster than     conventional continuous-output nebulizer devices. This study compares outcomes including     hospital admission rates, number of nebulized treatments required, and patient/family     satisfaction when a breath-actuated nebulizer device versus a conventional continuous-output     nebulizer is used to deliver asthma medications to pediatric asthma patients in the emergency     department.   "
243662|NCT01045187|"     Multicenter, non-randomized, feasibility study to evaluate the treatment and assess acute     safety of the FDA Cleared Axxent Electronic Brachytherapy System and vaginal applicator for     intracavitary vaginal cuff treatment according to the physician's current standard of care.   "
243663|NCT01045200|"     Follow-up programmes consume a large amount of resources with less time for the surgeon to     take on new patients. The aim of this randomised study was to compare patient satisfaction,     resource utilisation, and medical safety in patients curatively operated for rectal cancer     that were followed-up by a surgeon or a nurse.   "
243666|NCT01045239|"     The purpose of this study is to determine whether the new micropulse 577 nm yellow laser is a     better treatment option compared to the conventional 532 nm green laser for diabetic macular     edema.   "
243667|NCT01045252|"     The purpose of this study is to evaluate the hemodynamic values of neonates that are healthy     and those with various congenital heart diseases and sepsis by using echocardiography and     USCOM.   "
243668|NCT01045265|"     The objective of this study is to determine if concentrations of raltegravir in semen exceed     the 50% and 95% inhibitory concentrations of HIV during the dose interval.      The secondary objective is to determine the extend of raltegravir penetration into semen by     obtaining semen to plasma ratios across the dosing interval, to determine the area under the     concentration time curve of raltegravir in semen, and to determine the variability in the     penetration of raltegravir into the seminal compartment over the dosing period.   "
243669|NCT01045278|"     Hepatitis C is the leading cause of chronic liver disease in industrialized countries, and is     the most common indication for liver transplantation. In the Western world, the absolute     majority of cases of Hepatitis C Virus (HCV) infection are related to the use of injectable     narcotic drugs. Most injecting drug users contract HCV infection within the first years after     starting injecting drug use. The aim of this study is to study hepatitis C in a cohort of     patients registered in clinics providing maintenance therapy for opiate dependence in three     metropolitan areas of Sweden. The cohort is defined as all patients registered in these three     clinics at the date of study initiation. The study contains four parts:      Part I: the first part of the study aims to evaluate the prevalence of HCV exposure in the     cohort and the proportion of anti-HCV positive participants with chronic infection.      Part II: Patients with chronic HCV infection will be offered further investigation of chronic     liver disease, including liver biopsy, for selection of candidates for antiviral therapy and     identification of risk factors for development of severe liver disease.      Part III: Based on the results of these investigations, patients will be considered for     antiviral therapy. Indications for such therapy will mainly be clinical and/or histological     signs of chronic liver disease with fibrosis. All patients will receive weight-based doses of     pegylated interferon-alfa-2b and ribavirin.      Part IV: Study of pharmacokinetic interactions between ribavirin and opiate substitution     molecule (methadone or buprenorphine) in patients receiving antiviral therapy according to     part III.   "
243670|NCT01045291|"     The purpose of this research study is to evaluate the safety of a new pacing method (Fusion     Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a     period of 4 months, and determine the effects on different measures of heart failure. This     new pacing method may allow the heart to pump more efficiently. Participation in this study     will last approximately 8 months.   "
243671|NCT01045304|"     Primary Objective:        -  To assess the objective response rate (ORR) of iniparib (SAR240550) administered as a          60min intravenous (IV) infusion twice weekly or weekly, in combination with          gemcitabine/carboplatin chemotherapy regimen in patients with metastatic Triple Negative          Breast Cancer (mTNBC).      Secondary Objectives:        -  To assess the clinical benefit rate (CBR) defined as the rate of complete response (CR),          partial response (PR) and stable disease (SD) lasting at least 24 weeks;        -  To assess Progression-free survival (PFS) and the overall survival (OS);        -  To assess the safety profile of each schedule of iniparib;        -  To assess the biological activity in tumor tissue (substudy);        -  To evaluate the pharmacokinetic (PK) profile of iniparib (substudy);        -  To characterize molecular and biological profile of tumors (substudy);        -  To assess the effect of iniparib on poly(ADP)-ribose (PAR) level in peripheral blood          mononuclear cells (PBMC) (substudy).   "
243672|NCT01045317|"     To investigate the pharmacokinetics of PF-04776548 following administration of a micro-dose     of PF-04776548 via both intravenous and oral routes.   "
243673|NCT01045330|"     The aim is to replicate, develop, and pilot test a model of care for the prevention and     management of functional decline of older patients during hospitalization.   "
243674|NCT01045343|"     The purpose of this clinical trial is to evaluate the potential benefits of a new heart     failure diagnostic system for heart failure patients with implanted cardiac resynchronization     therapy devices. This system consists of patient tools, a new heart failure risk score and a     new clinician website. This study will evaluate this new system as a whole and establish the     feasibility of implementing it into clinical practice.   "
243675|NCT01045356|"     The purpose of this study is to measure blood levels of TXA in children having cardiac     surgery which requires cardiopulmonary bypass. TXA is used to reduce bleeding during surgery.     This study will help determine if the current dosing of TXA results in therapeutic blood     levels.   "
243676|NCT01045369|"     The purpose of this study is to see if using a combination of other drug classes, like the     ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your     blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so     their use in this study is experimental.   "
243677|NCT01045382|"     The present project aims at evaluating the capacity of MSC to improve one-year overall     survival of patients transplanted with HLA-mismatched PBSC from related or unrelated donors     after non-myeloablative conditioning.      Co-infusion of MSC has been shown to facilitate engraftment of hematopoietic stem cell (HSC)     in an immunodeficient mouse model. In addition, it has been shown that infusion of third     party MSC in HSC transplantation could be successfully used as treatment for grade II-IV     steroid-refractory acute graft versus host disease.      One hundred and twenty patients with HLA-mismatched donors will be included over 6 years at     multiple centers across Belgium through the transplant committee of the Belgian Hematological     Society. The conditioning regimen will consist of fludarabine and 2 Gy TBI, followed by the     infusion of donor HSC. Patients will be randomized 1/1 in double-blind fashion to receive or     not MSC (1.5-.3.0 x106/kg) from third-party (either haploidentical family members or     unrelated volunteer) donors on day 0. Postgrafting immunosuppression will combine tacrolimus     and MMF. Except for the collection, expansion and infusion of MSC, the clinical management of     the patient will not differ from that of routine NM-HCT.   "
243678|NCT01045395|"     Our overall goal is to evaluate the safety and efficacy of consumption of two algae     formulations compared to a placebo on: degree of severity of skin lesions, plasma lipid     levels, as well as other health-related markers, in individuals with clinically diagnosed     psoriasis.   "
243679|NCT01045408|"     Helicobacter pylori (HP) is the major risk factors of gastritis, gastric ulcers, duodenal     ulcers, mucosa associated lymphoid tissue lymphoma and gastric cancer. Helicobacter pylori     are found in 70-90% of the population in developing countries and in 25-50% of developed     countries.   "
243680|NCT01045421|"     This is an open-label, multicenter study with a phase 1 dose escalation portion and a     2-stage, phase 2 portion, investigating MLN8237 (alisertib) in patients with advanced     nonhematological malignancies.   "
243681|NCT01045434|"     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,     crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR capsules of Dr. Reddy's     Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets)of     Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fed     conditions.   "
243683|NCT01045460|"     Patient Population: Patients with active myeloma (Stage II/III) that have completed induction     therapy and are eligible for an autologous stem cell transplant.      Number of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of     aMILs vs aMILs plus vaccine. An evaluable patient is defined as one which has received the     activated MILs and is at least 6 months post-transplant.      Study Objectives:      Disease response as determined by the Blade' criteria will be the primary endpoint of the     trial at one year.      Additional study endpoints include progression free survival, parameters of T cell     reconstitution, anti-tumor immune responses as well as the effect on osteoclastogenesis and     clonogenic myeloma precursor cells.   "
243684|NCT01045473|"     The population of the US is aging. They remain more active and place greater demands on their     musculoskeletal system. A key problem is that pain and disability of age related spinal     disorders will increase. Problems such as Degenerative Lumbar Spondylolisthesis, Degenerative     Disk Disease, Spinal Stenosis and Degenerative Scoliosis are age related problems that are     treated with spinal fusion when non-operative treatment fails. Traditional open surgery poses     significant risk for patients in this age group. The use of minimally invasive spinal surgery     techniques provides an opportunity to treat these patients with less morbidity than     traditional open surgery.   "
243685|NCT01045486|"     There is not enough evidence to support the use of probiotics for prevention or treatment of     AD in children in clinical practice.      The purpose of this study is to determine whether probiotics is effective in the treatment of     atopic dermatitis with cow milk allergy.   "
243686|NCT01045499|"     Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected     morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or     older. Our hypothesis that LAGB can be used to assist selected adolescents between 14 and 17     years lose weight and that the procedure can be performed safely in this age group. We are     also evaluating the effects of weight loss after LAGB on known comorbid conditions such as     sleep apnea syndrome and insulin resistance, and also on psychological health.   "
243687|NCT01045512|"     In the elderly a chronic basal systemic inflammation prevails - which is evident by enhanced     CRP or IL-6 plasma concentrations - and by compromised defense mechanisms against invading     microbes. These alterations belong to the physiological ageing process of the immune system     (immunosenescence) and are regarded as an inflammatory response towards lifelong antigen     stress (inflammatory/pathogen burden). This lifelong antigen stress evokes an age-dependent     basal inflammatory activation of innate immunity as well as a wasting of specific immunity:     it is supposed that in the course of life-time due to a multitude of infectious/inflammatory     events (multiple hits) an inflammatory stress prevails or inflammatory/pathogen burden     accumulates, which substantially contributes to an enhancement of the inflammatory parameters     of natural immune response. Such enhanced inflammatory parameters characterize persons at     increased risk of degenerative diseases like atherosclerosis or coronary heart disease. The     risk is the higher, the higher the pathogen burden. An impact of the inflammatory load on     cardiac ageing has not yet been described.      CARDIAC AGEING, REFLECTED BY A NARROWING OF HEART RATE VARIABILITY: The physiological     ageing process of the heart goes along with a narrowing of heart rate variability as shown by     various groups, including our own. Arguments in favour of a causal relationship between     inflammation and cardiac ageing come from an experimental study with healthy human volunteers     who had received a low dose of endotoxin: such a proinflammatory stimulus leads to a     reversible narrowing of heart rate variability (7). Also in senescence heart rate variability     steadily declines, paralleled by a steady increase of basal inflammatory activity.      The reduction of heart rate variability also is regarded as a sensitive parameter of     autonomic dysfunction, which contributes to the compromise of cardiac reserve in old age.     Apart from typical morphological features and functional deterioration, e.g. diastolic     dysfunction, the senescent heart is typically characterized by a narrowed heart rate     variability. Efforts have been made to estimate the cardiac age of an individual by this     compromised heart rate variability, which may be divergent to the biological age. In recent     years diverse approaches were proposed to measure cardiac age on the basis of heart rate     variability. The published mathematical formulae were mostly validated with small patient     groups and have presently not entered clinical practice. Still heart rate variability is an     accepted surrogate parameter of cardiac ageing and is amenable by therapeutic measures, e.g.     beta-blockade.      The interaction between autonomic nervous system and inflammation is bilateral: thus vagal     stimulation can improve heart rate variability and at the same time evoke anti-inflammatory     action: this cholinergic anti-inflammatory reflex could make the basis for pharmacological     interventions to confine overwhelming inflammatory response syndromes. The afferent vagal     nerve, on the other hand, can be stimulated by inflammatory mediators and toxins (endotoxin,     Interleukin-1), thus activating the efferent vagus to release acetylcholine, which can bind     to a nicotinergic acetylcholine receptor on macrophages and thus interrupt cytokine release     and limit the rise in the blood levels of proinflammatory cytokines (TNF, IL-6). The     biological meaning of this reflex is to localise inflammatory reactions in the organism and     prevent a spill of cytokines to the circulation. A functioning autonomic nervous system is     thus mandatory to prevent overshooting of inflammatory response to infection and     non-infectious stimuli. The link between cardiac ageing and autonomic dysfunction gives     another argument in favour of the notion that autonomic dysfunction and pathogen/inflammatory     load could be factors promoting cardiac ageing. This, on the other hand, implies the chance     of slowing down the cardiac ageing process by successfully modulating the extent of autonomic     dysfunction and the scope of pathogen/inflammatory burden.      THE NEED FOR A TRIAL:      A possible causal relationship between basal inflammatory activation and cardiac ageing has     not been established. This is the issue of the project proposal. In this trial the     investigators strive to lower the pathogen/ inflammatory load by simple and safe measures.     The investigators therefore chose treatment with statins, standardised physical training     (both parameters of heart function and heart rate variability could thus be improved) and     vaccinations against influenza and pneumococci to prevent a further enhanced pathogen/     inflammatory burden.   "
243688|NCT01045525|"     Insulin resistance-associated hepatic iron overload (IR-HIO), also defined as dysmetabolic     iron overload syndrome or dysmetabolic liversiderosis, is a common cause or iron overload in     France, mainly in middle-age patients with increased serum ferritin levels associated with     normal serum transferrin saturation, and normal serum iron concentration in the absence of     other known cause of increased serum ferritin levels.      Treatment includes a combination of dietary measures and physical activity to correct     metabolic disorders. Phlebotomies seem to be beneficial when serum ferritin level is high.      This study aims at comparing the effect of iron depletion (by phlebotomy) plus lifestyle and     diet advices versus lifestyle and diet advices alone on blood glucose level and insulin     sensitivity in subjects with IR-HIO in order to assess the benefits of phlebotomies on the     reduction of risk of diabetes and cardiovascular associated complications.   "
243689|NCT01045538|"     There is scientific rationale for exploring the role of vorinostat, histone deacetylase     inhibitor with capecitabine (X) and cisplatin (P), one of standard chemotherapy in patients     with advanced gastric cancer. XP is a new standard of care in advanced gastric cancer (AGC)     and vorinostat is a novel targeted agent that prevents tumor cell proliferation, survival and     angiogenesis through histone deacetylase inhibition.   "
243690|NCT01045551|"     Rosacea is a chronic skin disorder with the signs and symptoms of facial flushing, persistent     redness, small visible spider-like veins, papules (inflamed red bumps under the skin) and     pustules. Rosacea is also a a recurring skin disorder. In addition to causing uncomfortable     and embarrassing physical symptoms such as flushing, burning, and itching, rosacea can also     contribute to lower self-esteem, which can have a significant psychosocial impact on quality     of life. Rosacea flares can be triggered by every day factors such as sun exposure, heat, hot     or caffeinated drinks, alcoholic beverages, spices and stress.      Many of the currently available treatments for rosacea are only partially effective and some     patients do not respond to them, or are unable to tolerate the side effects.      This is a single-center, open label trial of Apremilast in ten (10) subjects with moderate to     severe inflammatory rosacea who will be treated with Apremilast 20 mg twice per day for 12     weeks. Following the screening period and baseline visit, study subjects will return at weeks     1, 2, 4, 6, 8, 10 and 12. There is a follow up study visit at week 16.      Recent research has shown an increase of specific proinflammatory cytokines in the biopsies     of inflammatory lesions from rosacea and acne patients. The cytokines then trigger a chain of     chemical responses in the body that likely result in the development of the papules an     pustules that are seen in rosacea and acne patients. Apremilast is an oral agent that     modulates multiple anti-inflammatory pathways and has pharmacodynamic properties with     potential therapeutic benefit for treating inflammatory autoimmune disorders.      The investigators therefore propose a pilot study to evaluate the potential for Apremilast to     improve the signs and symptoms of moderate to severe inflammatory rosacea.   "
243691|NCT01045564|"     The purpose of this study is to characterize the immunogenicity and safety of 3 doses of     GSK's avian flu vaccine GSK 1557484A given at different time intervals to adults aged 18     years or greater who are at increased occupational risk of H5N1 exposure.   "
243692|NCT01045577|"     A double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity     of oral AB1010 in adults patients with moderate to severe chronic plaque psoriasis   "
243693|NCT01045590|"     Rationale Rosiglitazone and troglitazone both promote differentiation of pre-adipocytes into     adipocytes in subcutaneous, but not omental fat, and reduce gamma glutamyl transferase, a     surrogate marker for intra-abdominal and hepatic fat. Troglitazone has been shown by     abdominal computed tomography (CT) and magnetic resonance imaging (MRI) scan to reduce the     intra-abdominal adipose tissue area in type 2 diabetics. Similarly rosiglitazone has also     been shown to increase subcutaneous but not intra-abdominal fat in patients with type 2     diabetes. In the same study it was also shown to cause a substantial reduction in hepatic     fat. Central fat depots are believed to be associated with more cardiovascular risk than     subcutaneous fat depots. By contrast, sulphonylurea-associated weight gain has been shown by     abdominal CT scan to include increases in intra-abdominal adipose tissue.      The aim of this study is to compare the body fat distribution pattern of glibenclamide plus     rosiglitazone versus glibenclamide and placebo (especially the intra-abdominal adipose tissue     and abdominal subcutaneous adipose tissue areas) in patients with type 2 diabetes. It is     hypothesised that rosiglitazone will lead to the accumulation of excess energy stores in the     subcutaneous rather than the intra-abdominal adipose tissue depot. In addition, it is hoped     that by having a positive effect on diastolic blood pressure, lipid levels, BMI,     rosiglitazone will be shown to have a better cardiovascular risk profile when used in     combination with glibenclamide rather than when glibenclamide is used alone.      Although insulin resistance has been shown to be a primary defect causing type 2 diabetes     mellitus, insulin secretory defect has also been known to be an important factor in the     development of type 2 diabetes mellitus. A previous study has shown that in Korean patients,     early-phase insulin secretory defect may be the initial abnormality in the development of     type 2 diabetes mellitus [56].      This study also aims to assess the efficacy and safety of glibenclamide plus rosiglitazone     versus glibenclamide plus placebo therapy in Korean patients with type 2 diabetes. In     addition, a previous study has shown that in Korean patients, early-phase insulin secretory     defect may be the initial abnormality in the development of type 2 diabetes mellitus. This     study aims to show that rosiglitazone treatment in Korean patients, regardless of their early     phase insulin secretory ability, is just as efficacious and safe.      Objective(s) Primary To evaluate the effect of 12 months oral treatment with glibenclamide     plus rosiglitazone versus oral glibenclamide plus placebo, on body fat distribution (as     measured by the change in the ratio between the intra-abdominal adipose tissue and abdominal     subcutaneous adipose tissue areas) in patients with type 2 diabetes.      Secondary        -  To investigate the efficacy of glibenclamide plus rosiglitazone, compared to          glibenclamide plus placebo on beta-cell function and insulin resistance as calculated by          HOMA-B and HOMA-R.        -  To investigate the efficacy of glibenclamide plus rosiglitazone, compared to          glibenclamide plus placebo on fasting plasma glucose, insulin, fasting serum lipid          profile (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol and total          cholesterol to HDL cholesterol ratio).        -  To investigate the efficacy of glibenclamide plus rosiglitazone, compared to          glibenclamide plus placebo on early phase insulin secretion during an oral glucose          tolerance test as measured by the insulinogenic index.        -  To define further the clinical safety and tolerability of glibenclamide plus          rosiglitazone through the assessment of physical examinations, vital signs, weight,          routine laboratory tests, adverse experiences and electrocardiograms (ECGs).      Endpoint(s) Primary Change from baseline in the ratio (IAAT:SAT) between the intra-abdominal     adipose tissue area (IAAT) and abdominal subcutaneous adipose tissue area [SAT] after 12     months treatment with oral glibenclamide plus rosiglitazone compared to oral glibenclamide     plus placebo Secondary      Comparisons will be made between glibenclamide plus rosiglitazone and glibenclamide plus     placebo treatment groups on Change from baseline after 6 and 12 months treatment with respect     the following:      CT Scan      Derived from CT image at the lumbar IV level:        -  abdominal subcutaneous adipose tissue area [SAT]        -  intra-abdominal adipose tissue area [IAAT]      Derived from the CT image of the right leg at the thigh level (1cm below the gluteal fold):        -  total subcutaneous adipose tissue area [TSAT] Derived from CT images at the lumbar IV          and thigh level        -  ratio between abdominal subcutaneous adipose tissue area [SAT] and total subcutaneous          adipose tissue area of the thigh [TSAT]        -  ratio between intra-abdominal adipose tissue area [IAAT] and total subcutaneous adipose          tissue area of the thigh [TSAT] Derived from Oral Glucose Tolerance Test, glycaemic          response to OGTT, difference   "
243694|NCT01045603|"     The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the     treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and     distribution of dose strength. Data will be collected at three different time points over a 3     month period.   "
243739|NCT01050088|"     Babies with congenital clubfeet are treated by the Ponseti casting method. The procedure may     cause discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as     a comforting agent for the babies.   "
243707|NCT01045707|"     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of     this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart     (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with     metformin + at least one OAD (oral anti-diabetic drug).      The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension     period is registered as NN5401-3726.   "
243695|NCT01045616|"     Children born with very low birth weight and extremely low birth weight are at increased risk     of various ophthalmic challenges such as retinopathy of prematurity (ROP), refractive error,     strabismus, cerebral visual impairment, colour vision deficits, reduced contrast sensitivity     (CS), visual field defects, and decreased visual acuity (VA). Many of these factors are not     independent of each other. Among them, refractive error is a really common disorder. These     can cause significant disability which can impact life's activities and, qualities.     Currently, no standard guidelines are available toward the provision of ophthalmic follow up     care for preterm infants. It is important to survey the prevalence of different ophthalmic     sequelae in Taiwan, to identify the risk factors of developing these sequelae, and,     furthermore, to build up a screening program. The preterm population has heterogeneous     conditions to developing ophthalmic sequelae. National Taiwan University Hospital (NTUH) is     now in charge of a big part of intense care for these low birth weight preterm neonates. With     detailed medical record done of these children during care in the neonatal unit, we are     competence for this meaningful program.   "
243696|NCT01045629|"     The goal of this research is to understand whether schizophrenic patients are capable of     comprehending clinical trial consent form or influenced by disease, also after intensified     educational illustration for understanding of consent form, their comprehension increased     or not, in order to protect patient's right.   "
243697|NCT01045642|"     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,     crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR Capsules of Dr. Reddy's     Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets) of     Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fasting     conditions.   "
243698|NCT01045655|"     The study will evaluate the effectiveness of a culturally relevant, multi-component     intervention for antenatal depression. The intervention includes an engagement session, and     the woman's choice of brief interpersonal psychotherapy and/or pharmacotherapy in a stepped     care treatment for depression model.   "
243699|NCT01045668|"     This study aims to assess whether a combined technique of substrate ablation and ablation of     the clinically presenting VT at the site of early activation is superior to ablation of the     clinically presenting VT alone, in enhancing long-term success of VT ablation.   "
243700|NCT01039207|"     This phase II trial studies how well rilotumumab works in treating patients with ovarian     epithelial, fallopian tube, or primary peritoneal cancer that has failed to respond to other     therapies (persistent) or has returned after a period of improvement (recurrent). Rilotumumab     is a type of drug called a monoclonal antibody, and may interfere with the ability of tumor     cells to grow and spread by targeting certain cells and blocking them from working.   "
243701|NCT01039220|"     To estimate the incidence of H1N1v influenza-like illness and to study the risk factors for     serious influenza forms during pandemic period in French HIV infected patients.        -  Definitions:             -  Influenza like illness is defined as fever> 37°8C and cough or pharyngalgia.               (Centers for Disease Control definition).             -  Serious forms of influenza-like illness is defined by hospitalization within 14               days onset of symptoms or death attributed to influenza like illness.        -  Design:             -  Survey sampling for estimating H1N1v influenza-like illness incidence.             -  Out of approximately 50 000 patients under follow-up in one of the 40 ANRS centres,               a sub-group will be selected by random sampling. Sampling will be stratified by               centre and sampling fraction per site will vary in order to select 60 to 80               patients for this study per site. A total of 2500 to 3000 patients will be selected               to allow for estimating the incidence of H1N1v influenza-like illness with an               adequate precision.      Selected patients will be asked to contact the clinical staff on site as soon as any     influenza like symptoms appear. In the case of influenza like illness patients are requested     to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for     diagnosis of A(H1N1)v infection.      Nested case-control study for the determination of risk factors for serious forms:        -  Cases: Serious forms (see definition above) identified by any clinical site or          hospitalisation unit.        -  Controls: Patients of the randomly selected sample (see survey sampling above),          presenting with influenza-like illness without any criterion for severity.      Exhaustivity check:      The exhaustivity of symptomatic forms will be assessed a posteriori by merging information     from all available data sources.   "
243702|NCT01039233|"     The objective of this study is to compare the rate and extent of absorption of bicalutamide     50 mg tablet (test) versus Casodex (reference), administered as 1 x 50 mg tablet under     fasting conditions   "
243703|NCT01039259|"     Biofilms on oral piercings may serve as a bacterial reservoir and lead to systemic     bacteraemia or local transmission of periopathogenic microbiota.      The investigators hypothesize that there are microbiological differences in bacterial samples     collected from tongue /or lip piercings made of different materials. The investigators also     hypothesize that the piercings carry the same characteristic bacteria as found in the     piercing channels and that independently the biofilm on the tongue/adjacent teeth is similar     to the other study locations.      85 subjects with tongue and 85 subjects with lip piercing will participate. Periodontal     clinical parameters, traumata of hard tissues, and characteristics of the stud are evaluated.     Sterile piercings of four different materials will be randomly allocated to the study     subjects. After two weeks, microbiologic samples are collected and are processed by     checkerboard DNA-DNA hybridization methods.   "
243704|NCT01039272|"     The aim of this study is to analyze oral squamous cell carcinoma and healthy oral mucosa for     the possible presence of Epstein-Barr virus (EBV).   "
243705|NCT01045681|"     The present trial is designed as a phase II study that aims at estimating the efficacy of the     combination of bendamustine, bortezomib and dexamethasone in relapsed/refractory multiple     myeloma (MM). The response rate, i.e. the rate of the patients achieving a Complete Response     or Partial Response at cycle 4, divided by the total intent to treat patient number is chosen     as primary efficacy endpoint.      The estimation of the efficacy rate is to be based on an explorative pilot study, since     immediate embarking on a large-scale comparative efficacy trial would not be acceptable from     the point of view of resources. Moreover, this would induce ethical objections, as it does     not seem to be justifiable to expose a large number of patients to an experimental approach     without sufficient exploratory indications of an improved risk-benefit ratio.   "
243706|NCT01045694|"     Basal arthritis of the thumb is a common condition with increased prevalence in     post-menopausal women, obese persons, and the elderly. Surgical options are varied and     efficacious, but not all patients are candidates for surgery. The successes and pitfalls of     previous, similar trials are carefully considered in the creation of our own. Though steroid     injection is the standard of care in basal joint arthritis, current data does not support its     efficacy beyond placebo effect. No trial has yet examined the efficacy of botulinum toxin     type A (BTX-A) injection into the basal thumb joint nor compared it to steroid. Since     efficacy of steroid is questionable at best, our hope is that BTX-A injection of the basal     joint might be the next great tool in treating this common, debilitating disease.   "
243712|NCT01045772|"     This is a single-center open label study of the IL-1 transfusion protein rilonacept in     subjects with Muckle-Wells syndrome (MWS), or Schnitzler syndrome (SchS) in Germany.     Prospective subjects will be recruited from a patient population previously characterized in     an observational study, and from referrals within the German CAPS community; SchS subjects     will be recruited through the Charité Patient pool.      The Baseline phase will begin with the Screening visit (day -21 = Visit 1) and continue for     three weeks; DHAFs (Daily Health Assessment Forms) will be collected from all subjects from     Day - 21 to Day 0. DHAF information including MWAS (Muckle-Wells Activity Score), or SCHAS     (Schnitzler Activity Score) values from this period will be used for the baseline phase     evaluation. Inclusion to receive rilonacept will occur on day 0 (= Visit 2).      On day 0 eligible subjects will receive a loading dose of two subcutaneous (S.C.) injections     of rilonacept for a total of 320 mg. Subsequent study drug injections of rilonacept 160 mg     will be administered once a week for four weeks. After subjects complete this initial 4-week     treatment phase, they will be eligible to receive rilonacept 160 mg once weekly for 48 weeks     during the extended treatment phase.      DHAFs will be used to assess symptoms throughout the study. Overall a max. of 12 subjects     with either MWS or SchS will be enrolled.   "
243713|NCT01045785|"     The purpose of this study is to determine whether aspirin resistance has impact on     cardiovascular event in dialysis patient.   "
243714|NCT01045798|"     This is a pilot feasibility study that investigates antifungal therapy with caspofungin in     patients at high-risk for developing invasive candidiasis in a critical care setting.   "
243715|NCT01045811|"     The specific aims of this study are:        1. To develop a breathing training protocol specifically designed to improve HRV and          psychosocial functioning for postmenopausal women with depressive symptoms,        2. To examine the immediate effects of an 8-week breathing training program on HRV and          psychosocial end points in postmenopausal women with depressive symptoms,        3. To examine the intermediate-term effects of an 8-week breathing training program on HRV          and psychosocial end points in postmenopausal women with depressive symptoms, and        4. To determine whether the change in depressive symptoms with breathing training in          postmenopausal women is associated with the change in HRV.   "
243716|NCT01045824|"     The goal of this research is to find out possible susceptible gene(s) in schizophrenic     patients with family history and 5-year period functional changes of brain among the members     of family, in order to further analysis factors and their interactions.   "
243717|NCT01045837|"     Withdrawal of gluten, the culprit antigen, is the definite treatment for celiac disease.     Weeks to months after gluten withdrawal from the diet before the clinical manifestations,     histological features start improving. Many of the adult patients are in the critical phase     where even weeks may matter especially those in their adolescence where height growth has     limited potential.      Suppression of immune system using a short course of steroid might retard the immune mediated     destruction of the villi while the effect of gluten withdrawal sets in. Steroids are known to     be effective in the management of refractory celiac disease. Therefore, the investigators     hypothesized that addition of a short course of steroid to gluten free diet may enhance     intestinal mucosal recovery and thus clinical manifestations   "
243718|NCT01045850|"     Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and     hemorrhagic events associated with perioperative management of antiplatelet agents. Several     guidelines have outlined the importance of maintaining antiplatelet agents throughout     surgical procedures to prevent cardiovascular complications. On the other hand, interruption     of antiplatelet agents is still a usual standard to avoid surgical complications. We     investigate the impact of perioperative antiplatelet drugs management on these complications,     through a multicenter, prospective cohort (RECO stands for Registre des patients porteurs     d'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque), including all patients with     coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study     is primarily to measure the incidence of cardiovascular (including stent thrombosis) and     hemorrhagic complications and to identify pre and postoperative risk factors associated with     these complications.   "
243719|NCT01045863|"     The purpose of this study is to evaluate safety and tolerability after a single     administration of PF-03382792 in healthy volunteers.; and to evaluate plasma drug levels and     biological activity.   "
243720|NCT01045876|"     Many drugs are used to prevent nausea and vomiting and pain after surgery. In this study the     investigators will be looking at a drug, dexamethasone, which is commonly used to prevent     nausea and vomiting and pain after surgery but has other side effects. Dexamethasone is a     man-made drug that is commonly used during surgery but also can affect naturally occuring     hormones. In this study the investigators will be looking at dexamethasone's effect on a     number of naturally occuring hormones over a twenty four hour period after thyroid surgery.     The investigators hypothesize that plasma cortisol levels will be decreased following     administration of dexamethasone.   "
243724|NCT01045928|"     RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor.     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer cells to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Giving lenalidomide together with rituximab     may be an effective treatment for B-cell non-Hodgkin lymphoma.      PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide     when given together with rituximab as maintenance therapy in treating patients with B-cell     non-Hodgkin lymphoma.   "
243725|NCT01045941|"     We believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and     significantly reduces the chances of postoperative wound breakdown. This will shorten the     wait time required to begin adjuvant therapy to one week after surgery thereby combating the     micrometastasis unseen at the time of surgery. Prognosis for patients with pancreatic cancer     will therefore improve along with decreasing the incidence of locoregional recurrence.   "
243726|NCT01045954|"     This study will be conducted in subjects with Type 1 diabetes mellitus on multiple daily     insulin injections to determine the correct insulin dosing formulas. Subjects will be     evaluated using continuous glucose monitoring.   "
243895|NCT01052142|"     The purpose of this study is to determine whether Lipovaxin-MM, a new anti-cancer vaccine, is     safe and effective in improving the body's ability to destroy cancer cells in patients with     metastatic melanoma.   "
243727|NCT01045967|"     The object of this study is to compare the relative bioavailability of lansoprazole 30 mg     delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and     distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP     Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting conditions.   "
243728|NCT01045980|"     The main purpose of this study is to compare the effects of using bio-impedance analysis to     guide management of fluid status versus routine clinical care on heart structure. In     addition, Vitamin D is being assessed to determine its effect on heart structure.   "
243729|NCT01045993|"     The study is designed to assess methods used in clinical research.   "
243730|NCT01046006|"     Rituximab is a monoclonal antibody with proven efficacy in WM but responses are slow.     Bortezomib has shown significant and rapid activity in WM. Combinations of bortezomib with     rituximab nad dexamethasone with rituximab have shown synergistic activity in laboratory     studies and clinical trials. This is a Phase II multicenter study designed to evaluate the     safety and efficacy of the combination of Bortezomib , Rituximab and dexamethasone (BDR). BDR     will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles     to patients with WM. Bortezomib will be administered as an iv push over 3 to 5 seconds at a     dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle 1. On cycles 2-5 bortezomib will be given     at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5,     following the administration of Bortezomib, dexamethasone 40mg iv and Rituximab 375 mg/m2 iv     will be administered. A total of 8 infusions of rituximab will be administered. Subsequently     patients rated as CR, PR, MR or SD will be followed without any treatment until there is     evidence of progressive disease.   "
243731|NCT01049984|"     To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist     therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine     agonists as compared to placebo.   "
243732|NCT01049997|"     The purpose of this study is to describe patients, 75 years old or older, with Non ST     Elevation Myocardial Infarction (NSTEMI) especially regarding the following variables:     cardiovascular risk, co-morbidity and frailty. The investigators hypothesize that the degree     of frailty influences the benefit from coronary angiography and the possible invasive     treatment which can follow.   "
243733|NCT01050010|"     The major aim of treatment for rheumatoid arthritis is remission. Nevertheless, structural     radiographic progression is observed in 15 to 20% of patient getting remission. Numerous     definitions of the remission proposed by literature remain imperfect.      Recently ultrasonography and MRI seem to be helpful in diagnosis and follow-up of rheumatoid     arthritis.      Studies in patients with clinical remission are reporting 75 to 90% of persistent MRI and     ultrasonography synovitis, 45% of cases with synovial activity.      To our knowledge, in such case few studies showed correlation between persistent imaging     synovitis and structural radiographic progression.      On the other hand, no studies with extremity dedicated RMI in patients with remission are     reported.      In this preliminary study, the investigators propose to evaluate in patients with rheumatoid     arthritis remission and persistent dedicated MRI synovitis the structural radiographic     progression at one year.   "
243734|NCT01050023|"     This pilot study hypothesizes that use of the Regenesis Provant Wound Therapy System (a     radiofrequency device) twice daily over venous stasis ulcers (wounds thought to occur due to     improper functioning of valves in the veins, usually of the legs) will result in increased     rates of healing and a larger proportion of completely healed wounds after 12 weeks of     therapy compared to wounds treated identically using a Provant device that is not activated     to emit radiofrequency.   "
243735|NCT01050036|"     Primary study objective is the evaluation of efficacy of autologous hematopoietic cell     transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in     the first CR (CR1) in terms of relapse incidence (cumulative incidence of relapse, CIR) and     disease-free survival (DFS).      Secondary study objectives are the engraftment rate / time to engraftment,     transplantation-related mortality (TRM) rate, event-free survival (EFS) rate, and Overall     survival (OS).   "
243736|NCT01050049|"     The objective of this study is to determine if the implementation of guidelines utilizing     immediate CT Perfusion and CT Angiography in addition to non-contrast CT alters (reduces or     increases) the time to decision-making for or against rt-PA in acute ischemic stroke, and by     extension, time to therapy in treated patients and time to transfer from the department for     all patients. A secondary objective is to determine if using CTP/CTA-inclusive hyperacute     stroke guidelines improves safety by decreasing symptomatic intracerebral hemorrhage and     mortality in patients who receive rt-PA.   "
243737|NCT01050062|"     The survey is conducted to collect safety and effectiveness information in Hypertensive     patients treated with Micombi Tablets on the long term use in daily clinical settings in     Japan.   "
243738|NCT01050075|"     RATIONALE: Acupuncture may help relieve nerve pain caused by chemotherapy.      PURPOSE: This randomized clinical trial is studying how well acupuncture works in treating     nerve pain in patients with stage I, stage II, and stage III breast cancer who are receiving     paclitaxel.   "
243740|NCT01050101|"     In this research study, investigators are interested in how certain dietary fibers in the     diet affect certain hormones released from your intestine after eating and how these     influence your appetite. The study hypothesis is that certain fibers will slow digestion and     absorption of nutrients thereby optimizing fullness,reducing food intake and limiting insulin     response in pre- and post-menopausal women.   "
243752|NCT01050257|"     This partially randomized, multi-center parallel-group study will evaluate the safety,     pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in     patients with influenza. Adult and adolescent patients will be randomized to receive either     100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are     blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral     Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days,     with an optional treatment extension of a further 5 days, if necessary. There will be a     non-randomized, open-label treatment group for patients with moderate/severe renal impairment     or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to     their renal situation.   "
243896|NCT01052155|"     Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain     Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass     Spectometry (LC/MS/MS)   "
243741|NCT01050114|"     Overactive bladder is a condition associated with symptoms of feeling the urge to urinate,     urinating often, and may or may not be accompanied by leakage of urine. A patient who has a     spinal cord injury (SCI) often suffers from an overactive bladder which often leads to     urinary incontinence (UI - an unwanted leakage of urine).      OnaBoNT-A bladder injections have been studied in clinical research trials. The results have     shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by     increasing the amount of urine the bladder can hold.      This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when     injected into the bladder for the treatment of UI and if it works better than a drug that is     taken by mouth. A second purpose of the study is to perform research tests on the urine     samples provided by the volunteers. Urine presents a rich source of information for bladder     diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to     learn if there are yet undiscovered reasons for urinary diseases. These tests would be very     beneficial because the results would lead to better treatment of the urinary diseases.      Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and placebo     oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER 10mg     capsule twice a day.      The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or     placebo bladder injection and oxybutynin ER (like Ditropan) capsule twice a day. Placebo     contains no active medicine. Participation in this study will be about 6-7 months and involve     5 visits to the clinic. The risks of bladder onaBoNT-A   "
243742|NCT01050127|"     The objectives of this study are to assess the safety, tolerability, pharmacodynamics and     pharmacokinetics of multiple doses of ABT-436 in healthy adults.   "
243743|NCT01050140|"     Dietary consumption of fructose has increased by nearly 50% since 1960.      A high fructose diet (HFrD) results in greater visceral adiposity and systemic insulin     resistance than a high glucose diet. The effects of fructose on liver fatty acid and ATP     stores, systemic oxidative stress and cardiovascular status are not fully known.   "
243744|NCT01050153|"     This study plans to learn more about how to prevent blood clots in the veins of your     extremities. You are at risk of forming these clots after a major injury and when you have     had surgery and are hospitalized on bed rest.      Usually, patients in the SICU at Denver Health who are at risk for blood clots receive     preventative treatment with a FDA-approved medicine called Fragmin. Fragmin is intended to     prevent blood clots from forming but, with the way it is generally used, some patients may     still develop blood clots. All patients treated with Fragmin to prevent blood clots at Denver     Health, currently receive the same Fragmin dose. This treatment is called the standard of     care.      So far, in the US, there has not been a commonly available test that can tell us:        -  if the standard dose of Fragmin is enough to prevent blood clots for everyone, or        -  if different patients need different doses, or        -  if other blood clot preventing medicines, that work in a different way, should be used          in addition to Fragmin.      The ability of your blood to clot and the strength of the clot formed can be described by a     FDA-approved blood test called thrombelastography, referred to as TEG. TEG may provide us     with answers to each of the questions above. Our preliminary data indicate that it is helpful     in assessing both clotting and bleeding tendencies and may prove useful in guiding treatment     for the prevention of blood clots.      The aim of this study is to determine if a treatment plan using Fragmin, and, if indicated,     one or two additional FDA-approved medicines called anti-platelet drugs, guided by the     results of TEG testing, may be better at preventing blood clots than our current standard of     care.   "
243745|NCT01050166|"     The purpose of the study is to determine whether human islets labeled by iron contrast agents     could be imaged using magnetic resonance after transplantation into the liver of Type 1     diabetic recipients.   "
243746|NCT01050179|"     The purpose of this study is to assess chemoreflex gain on exercise.   "
243747|NCT01050192|"     The purpose of this study is to determine the correlation, if any, between the nutritional     content of breast milk pumped by the mothers of very low birth weight (VLBW) infants in the     neonatal intensive care unit (NICU) and the nutritional value they are actually receiving in     a 24 hour period, since as a practical matter, these may not be the same.   "
243748|NCT01050205|"     The Diabetes Prevention Program (DPP), a large research study conducted in the United States,     found that lifestyle intervention was effective in lowering risk for development of type 2     diabetes. It is important to evaluate the DPP lifestyle interventions in real world     settings. The purpose of this project is to test an adapted version of the DPP lifestyle     intervention in several community settings, including a worksite, a health care facility     (primary care practice and local community centers dedicated to older adults.   "
243749|NCT01050218|"     The purpose of the study is to learn if long-term treatment with DVS SR is safe for treating     the pain and other symptoms associated with diabetic peripheral neuropathy.   "
243750|NCT01050231|"     The purpose of this study is to develop an upper extremity robotic training system for use by     people with stroke to practice arm and hand movement in the clinic.   "
243751|NCT01050244|"     Neuropathic pain is one form of chronic pain lacking effective pharmacotherapy. Interest in     the role of complementary and alternative medicine is growing and diet is at the forefront of     the search for alternative treatments for pain. Soy protein is one of the most promising     dietary ingredients tested for its pain-relieving properties. Results from animal studies     show that soy-enriched diets reduce pain due to nerve injury. The purpose of this study is to     determine the effects of soy protein supplementation on facial pain.   "
243762|NCT01050387|"     The purpose of this study is to determine if the vitamin D binding protein genotype     influences circulating vitamin D levels and if it may have functional consequences on vitamin     D activity.   "
243763|NCT01050400|"     The purpose of this study is to determine if non-invasive salivary genetic screening of     breastfeeding mothers taking codeine will allow for the successful identification of     mother-infant pairs susceptible to adverse events and to prevent these adverse events by     personalizing their medication to their genetics.   "
243767|NCT01050452|"     This randomised, controlled, double-blinded clinical study investigates the safety and     efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and     MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged     5-14 years.   "
243753|NCT01050270|"     This study is designed to assess the impact of new approaches to therapy for paracetamol     poisoning. Standard therapy is currently acetylcysteine by intravenous infusion over 20.25h.     This regimen is given to those deemed at risk using standard criteria (British National     Formulary 200920). It has 3 major problems, adverse events (nausea and vomiting and     anaphylactoid reactions), therapy duration and complexity of administration.      This study is primarily designed to test the efficacy of prophylactic anti-emetic therapy.      It will also provide sufficient experience and data from a modified shortened IV     acetylcysteine regimen to adequately design and power a study of the modified regimen as a     new treatment for this common poison. Such an approach has a major potential to reduce     patient adverse events from acetylcysteine therapy and shorten duration of hospital stay.   "
243754|NCT01050283|"     This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography     (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.   "
243755|NCT01050296|"     This study will prospectively characterize the molecular, cellular and genetic properties of     primary and metastatic neuroblastoma, osteosarcoma, retinoblastoma, Ewing sarcoma family of     tumors, soft tissue sarcomas, adrenocortical tumors and liver malignancies. These cell     isolates will be used for gene expression array analysis, genomic analysis by [SNP] single     nucleotide polymorphism chip, array [CGH] comparative genomic hybridization and next     generation sequencing, and [TEM] transmission electron microscopy analysis. Additionally cell     lines and orthotopic xenografts will be created from the obtained tumor specimens.      The specificity of TCRs will be examined by comparing paired TCR from peripheral blood and     tumor infiltrating CD4+ and CD8+ T cells. Epigenetic studies will be performed looking at the     methylation profile of these cells and to investigate the anti-tumor T cell response both     pre- and post-PD1 inhibition.   "
243756|NCT01050309|"     The study will determine the extent of systemic absorption of HAL following vaginal and enema     administration compared to intravenous administration to healthy female volunteers.      In addition, the pharmacokinetic parameters for the combined level of 14C labelled substances     (sum of parent and possible metabolites)will be assessed. The safety and tolerability of HAL     following vaginal, enema and intravenous administration to healthy female volunteers will be     investigated.   "
243757|NCT01050322|"     Despite these initial positive signals in recent statistics, breast cancer continues to claim     a substantial number of lives approximately 500,000 deaths worldwide in 2005 Thus the current     treatment paradigm - surgery, radiation and systemic chemo and or hormonal therapy and     biological therapies -still fails to cure a significant number of women with early breast     cancer and new treatment strategies are needed to improve current results both in early and     advance disease.      Recurrent or metastatic breast cancer is an incurable malignancy with a median survival of     20-24 months [Hortobagyi , 1998] and this has not changed significantly over the last decade     with fewer than 20% of patients still alive at 5 years after a diagnosis of recurrence.     Although there have been small improvements in survival with the new therapies, metastatic     breast cancer remains an incurable and, ultimately, fatal disease. The introduction of novel     combination therapies have the potential to target different pathways in the cancer cell,     leading to improved efficacy. Further studies to optimize combination therapy, while     ameliorating AEs, are critically important to patients with metastatic breast cancer.      Lapatinib is an oral tyrosine kinase inhibitor which potently inhibits both EGFR and     HER2[Spector, 2005]. Lapatinib in combination with capecitabine is approved in more than 20     countries for the treatment of patients with advanced or metastatic breast cancer whose     tumors overexpress HER2. All patients in the study leading to the lapatinib approval had     received prior therapy including an anthracycline, a taxane, and trastuzumab.      The relevance of the HER2/neu target in breast cancer, combined with the promising     preclinical and clinical data regarding the use of lapatinib, provide the rationale for a     formal evaluation of this agent combined with other non taxane agents as gemcitabine or     vinorelbine after progression on taxanes and trastuzumab based therapies in metastatic     disease setting as these chemotherapy options are used in daily practice in this subset of     patients.      This is a randomized phase II, open label,multicentric , international, 3 arms treatment     study in patients with confirmed HER2+ metastatic breast cancer after taxane progression .     The main objective is to investigate the (CBR) and safety in 3 different combinations of     Lapatinib therapy (plus capecitabine or gemcitabine or vinorelbine) and to determine whether     either, or both, of Lapatinib /Vinorelbine or Lapatinib/Gemcitabine can be considered a     reasonable alternative to the established Lapatinib/Capecitabine standard combination . The     decision as to whether to study either of the new combinations further will be based on both     the toxicity and the efficacy profiles.   "
243758|NCT01050335|"     The purpose of this study is to provide a quantitative base line comparison to determine a     surgeon's proficiency based on that surgeon's hand and tool movements while performing     simulation tasks.   "
243759|NCT01050348|"     This is a double-blinded randomized placebo controlled trial investigating the role of     upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for     acute STEMI.   "
243760|NCT01050361|"     The growing population of University of Nebraska Medical Center patients with heart failure     combined with the increasing number of surgical procedures performed each year supports the     need for a critical analysis of how to most appropriately manage these patients during the     perioperative period, especially for non-cardiac surgery. Echo-guided hemodynamic management     (EGHEM) is the use of echocardiography data to normalize and/or optimize in real-time,     cardiac output and ventricular filling pressures in the perioperative period for non-cardiac     surgical cases. The purpose of this study is to test the hypothesis that EGHEM compared to     standard management practices will result in a reduced length of hospital stay in the     noncardiac surgery population. The primary goal of health care providers for patients     requiring anesthetic care, perioperative care, or critical care is ensuring the adequacy of     the patient's circulatory function by optimizing cardiac output and ventricular filling     pressure. Currently, the use of the ECG monitor and systemic blood pressure are the standard     of care for assessing circulatory function. However, those data cannot provide accurate     information on cardiac output and ventricular filling pressure for patients with     cardiovascular risk factors and/or comorbidities. As a result, managing the hemodynamic     parameters of these patients, as well as their intravenous fluid needs and resuscitation     strategy, we hypothesize that using traditional approaches may lead to significant volume     overload and post-operative cardiovascular complications and morbidity. In this study we     propose an EGHEM strategy that incorporates standard echocardiography generated data points     in addition to the systemic blood pressure and ECG signal to assess, manage, modify and     optimize patient cardiac preload, afterload, heart rate and contractility in the     perioperative period. Based on our initial observations and preliminary data using the EGHEM     approach, we hypothesize that we can demonstrate a significant decrease in hospital length of     stay and an overall decrease in perioperative morbidity at 30 days in the non-cardiac surgery     population using EGHEM compared to standard practices. In this proposal we have designed a     single center, prospective, randomized clinical trial to test our hypothesis.   "
243761|NCT01050374|"     This randomised, controlled, double-blinded clinical study investigates the safety and     efficacy of MBD in combination with PZQ in the treatment of SCH and STH in children aged 1-15     years of age.   "
243764|NCT01050413|"     This study aimed to evaluate serum thymidine kinase 1 (TK1) activity as a marker for solid     tumors and more specifically in: preoperative testing for prediction of disease recurrence     and survival; follow-up after surgical removal of the original tumor for early detection of     disease recurrence and in monitoring therapy as a surrogate marker of tumor response.   "
243765|NCT01050426|"     The purpose is to assess the overall survival of patients receiving either UFT/LV +     radiotherapy (RT) or UFT/LV + Cetuximab + RT after neo-adjuvant chemotherapy.   "
243766|NCT01050439|"     Unrelated matched donor (cord blood, bone marrow or peripheral blood) allogeneic stem cell     transplantation (UDAlloSCT) with either myeloablative or reduced intensity conditioning will     be well tolerated and result in a high degree of engraftment in patients with selected     malignant and non malignant disorders.   "
243769|NCT01050478|"     This study will investigate the effect of paliperidone ER (in combination with or without     benzodiazepines) in patients presenting with symptoms of agitation and/or aggression in the     context of psychosis, and will generate data regarding both efficacy and safety in the acute     setting.   "
243770|NCT01050491|"     Introduction. Despite adequate steroid therapy, a subpopulation of approximately 10% of     asthmatics develops severe persistent airflow obstruction. It is now widely agreed that the     latter is the consequence of a remodeling process of the airways, characterized by an     increase in airway smooth muscle mass, mucus gland hypertrophy, increased thickness of the     subepithelial basement membrane, extracellular matrix protein deposition, angiogenesis,     fibroblast and myofibroblast accumulation. These phenomena are responsible for airway wall     thickening and for decreased airway caliber leading to persistent airflow obstruction.      Endothelin-1 (ET-1) is a small peptide, synthesized in the lung by airway epithelial and     smooth muscle cells, as well as inflammatory cells. ET-1 induces bronchoconstriction,     mediates eosinophils recruitment during allergic inflammation and contributes to airway     remodeling by inducing fibroblasts and smooth muscle cells differentiation and proliferation.     In a recent work from Inserm Unit 700, it has been shown that ET-1 was overexpressed in     epithelial cells from severe asthmatic patients as compared to patients with less severe     disease, and that ET-1 expression was strongly correlated with airway obstruction (measured     by FEV1) and on bronchial biopsies with airway smooth muscle areas. In another study, we have     shown that a polymorphism of the receptor for ET-1 was strongly associated with the degree of     airway obstruction in a population of asthmatic patients. All these data suggest that     inhibition of the ET-1 pathway could be a potential therapeutic option in patients with     steroids refractory asthma and irreversible airway obstruction. Bosentan, a specific     inhibitor of ET-1 receptors which is actually used in patients with pulmonary hypertension,     improves survival and inhibits vascular remodeling.      Aim and strategy. To study the impact on airway remodeling and clinical status of an     antagonist of the endothelin receptors (Sitaxentan 100mg/day) over a 12-month period, in a     prospective randomised placebo-controlled trial involving two parallel groups of 25 severe     asthmatic patients with irreversible airflow obstruction (FEV1≤ 70% of predicted) . Various     hallmarks of airway remodeling will be analyzed on bronchial biopsy specimens by     immunohistochemistry and morphometry. These findings will be correlated with the results of     pulmonary function tests. Twenty-five patients will be included in each group. Remodeling     will be measured on bronchial biopsies performed during fiberoptic bronchoscopy at inclusion     and after one year, by assessing smooth muscle area, submucosal fibroblasts count and     basement membrane thickness. Every 3 months, bronchial obstruction (FEV1), clinical status,     asthma exacerbations, steroids use, need for emergency care, asthma symptoms and quality of     life will be assessed. Evaluation of airway inflammation will be assessed every 3 months by     exhaled NO and induced sputum cytology.      This proof of concept study will validate ET-1 as a new molecular target for treating airway     remodeling in patients with severe asthma.   "
243771|NCT01050504|"     This research trial collects and studies tissue and blood samples from patients with prostate     or bladder/urothelial cancer that has recurred (come back) at or near the same place as the     original (primary) tumor or has spread to other parts of the body. Studying samples of blood     and tissue samples from patients with prostate or bladder/urothelial cancer in the laboratory     may help doctors learn more about new biomarkers, potential drug targets, and resistance     developing in response to treatment. It may also help doctors find better ways to treat the     cancer.   "
243772|NCT01050517|"     This randomised, controlled, double blinded clinical study investigates the safety and     efficacy of the combination of albendazole, ivermectin and praziquantel in the treatment of     children aged 5-18 years co-infected with lymphatic filariasis, schistosomiasis and     soil-transmitted helminthiasis.   "
243773|NCT01050530|"     OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to     cirrhosis patients with ascites despite having received treatment with conventional diuretics     and the change in body weight from baseline at the time of the final administration will be     compared between the two groups.   "
243774|NCT01050543|"     This is a randomized, active-controlled, parallel-group, single-dose, multi-site,     safety-assessor blinded study comparing sugammadex to neostigmine for reversal of     neuromuscular blockade in Korean subjects undergoing elective surgical procedures under     general anesthesia that require rocuronium for neuromuscular blockade. Study medication will     be administered at reappearance of T2. Time to recovery will be measured from start of study     medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is     that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with     neostigmine.   "
243775|NCT01050556|"     The purpose of this study is to determine whether folic acid, alone or together with creatine     supplementation, can lower blood arsenic concentrations and improve the ability to detoxify     arsenic.   "
243776|NCT01050569|"     The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine     patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only     and very low nicotine content cigarette only on abstinence, time to relapse and toxicant     levels. The study will determine if adding nicotine replacement medication to the very low     content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very     low nicotine content cigarettes only.   "
243777|NCT01050582|"     The purpose of this study is to evaluate the effects of risperidone compared with other     atypical antipsychotic drugs on the physical maturity, growth and development of children,     and the risk of prolactin-related adverse events (side effects) associated to these drugs.   "
243778|NCT01050595|"     The purpose of this study is to determine if there will be a significantly higher incidence     of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with     decreased need for rescue medications in the intensive care unit in patients with     opioid-induced constipation. Patients will also be managed with an aggressive bowel     management protocol.   "
243779|NCT01050608|"     Evaluate the efficacy of a multimodal hand hygiene system in the intensive care unit     environment and evaluate any impact on health care associated infections.   "
243780|NCT01050621|"     Concurrent administration of intravenous vitamin C (ascorbic acid, 1.5 g/kg, infused two or     three times weekly) together with certain cytotoxic chemotherapy regimens could prove to be     an effective treatment for some patients with advanced malignancies for whom existing     chemotherapy is usually ineffective. The primary objectives of this study are to identify a     tolerable and safe dose of intravenous vitamin C when administered during cytotoxic     chemotherapy while attempting to empirically identify specific vitamin C-chemotherapy     regimens for which the clinical response is unusually favorable after a minimum of 2 months     of therapy, as determined by CT scan and biomarkers, when appropriate.   "
243781|NCT01050634|"     Quality of life under therapy with Aromasin® (exemestane) according to IBCSG (International     Breast Cancer Study Group) questionnaire.      Change of the endometrium after switching from tamoxifen to Aromasin® (exemestane).      Deeper knowledge of Adverse Events during routine administration.   "
243782|NCT01050647|"     Preterm birth is the leading cause of neonatal death and a significant cause of life long     disability and health problems. It has been shown that the drug 17-hydroxyprogesterone     caproate can help reduce the risk of preterm delivery in women with certain risk factors for     preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy     in a group of patients in whom this medication has not been previously studied. Specifically,     we hope to learn whether progesterone supplementation will delay delivery in women with     pre-term, premature rupture of membranes (PPROM).   "
243784|NCT01050673|"     It is increasingly recognised that the debridement of devitalised, bacterially contaminated     or senescent tissue is an essential component of the effective treatment of delayed healing     wounds.      Whilst surgical debridement procedures have conventionally been performed with scalpels and     other sharp instrumentation, alternative techniques such as the VERSAJET Hydrosurgery System     are becoming more widespread.      To increase the adoption of this new technology, it is essential that clinical improvements     are assessed alongside the potential impact on the costs of debridement and the net financial     impact on the hospital.      It is hypothesised that a decrease in the time to achieve stable wound closure will not only     lead to a patient benefit, but also a potential reduction in the cost of treatment due to     e.g. repeat procedures, longer hospital stay, infection etc. The purpose of this study is to     investigate the difference in time to closure of wounds surgically excised with VERSAJET     Hydrosurgery System and those surgically excised using conventional operating room     techniques.   "
243785|NCT01050686|"     The purpose of this study is to find out whether the insertion of subcutaneous wound drains     has an influence on postoperative hospital stay in ileostomy reversal.   "
243840|NCT01051401|"     This randomized pilot clinical trial studies rosuvastatin in treating women with     cardiovascular complications who are undergoing chemotherapy for breast cancer. Rosuvastatin     may prevent or lessen cardiovascular complications in patients undergoing chemotherapy for     breast cancer   "
243786|NCT01050699|"     The central purpose of this proposal is to study the short-term effects of sedation with     sympatholysis, using α2 adrenergic agent Dexmedetomidine, on sleep and inflammation in     critically ill patients with Acute Lung Injury and Acute Respiratory Disorder Syndrome     (ALI/ARDS). An additional objective is to determine the effect of Dexmedetomidine sedation on     the in-vitro production of sleep-modulating inflammatory cytokines by peripheral blood     mononuclear cells of critically ill patients with ALI/ARDS.   "
243787|NCT01050712|"     Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care     problem. It normally occurs in all patients after surgery to the abdomen but in some cases     can result in serious complications. The objective of this study is to determine if inhaling     very low doses of carbon monoxide (CO) before and after colon surgery will shorten the     duration of normal POI and/or prevent the development of POI complications in patients     undergoing colon surgery.      A preliminary study will be conducted in six healthy volunteers to monitor for blood levels     and adverse effects that occur at 3 different doses of inhaled CO to establish a safe dose     for patients in the main trial. For the main trial, patients requiring surgery to their colon     will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask     before and after their operation. Length of normal POI and occurrence of POI complications     will be compared between the two groups. Side effects that occur from inhaling CO or oxygen     will also be recorded.      We hypothesize that inhaling CO before and after colon surgery will shorten the length of     normal POI and decrease the occurrence of POI complications with minimal side effects.   "
243788|NCT01050725|"     The purpose of this study is to determine whether specific assays of DNA damage repair     proteins can be used in patients undergoing radiation therapy. The ultimate goal of this     research is to develop clinically useful biomarkers from blood samples that could be used to     customize radiation treatment for individuals, leading to reduced side effects and improved     outcomes.   "
243789|NCT01050738|"     Postoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement     of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new     concept for pain relieve postoperative is local infiltration analgesia (LIA). This technique     implicates that a catheter is left in the surgical area and that local anestesia can be     administered post surgery. The goal is no or only little pain with minimal side effects. The     catheter could be placed intra- or extracapsulare. The best position is not known. Primary     aim is to study if position of the catheter effects the need of other postoperative     analgesia. Secondary aim is to study if the position effects patient mobility within the     first two days.   "
243790|NCT01050751|"     This is a randomized study to assess whether the pharmacokinetics of a new single 750 mg     tablet is similar to 3 x 250 mg tablets (750 mg total).   "
243791|NCT01050764|"     Patients with hematologic malignancies will receive myeloablative chemotherapy followed by     stem cell rescue with bone marrow or hematopoietic peripheral blood stem cells collected by     apheresis from a filgrastim- (G-CSF)-mobilized haploidentical related-donor, ie,     hematopoietic peripheral blood stem cell transplant (HSCT).   "
243792|NCT01050777|"     Leishmaniasis with diverse clinical manifestations is caused by different species of     Leishmania and is endemic in many countries. Although Cutaneous Leishmaniasis (CL) is a     self-healing disease, but it takes a long time to heal. Pentavalent antimonials are still the     first-line treatment of CL which needs multiple injections, are painful and as such not     tolerated by most of the patients, in addition available treatments are not always effective     and resistance is reported. Paromomycin sulfate (PM) reported to show anti-Leishmania     activity against both CL and visceral leishmaniasis (VL) since 1960s. Therapeutic strategy     with high efficacy is urgently needed especially for Anthroponotic Cutaneous Leishmaniasis     (ACL). Liposomes are lipid bilayer molecules which entrap water-soluble molecules in their     internal water compartment and water-insoluble ones into their lipid bilayers. Liposomes, in     proper formulations and sizes, deliver drugs to the skin based on the similarity of the     bilayers structure of lipid vesicles to that of natural membrane and target the macrophages     within dermis. Several lipid-based formulations have been developed to treat experimental     leishmaniasis. Recently different doses of liposomal formulation of PM and liposomal     formulation of Glucantime were prepared and showed high efficacy in vivo against L. major     infection in BALB/c mice.      In this study the efficacy of liposomal formulation of PM or liposomal formulation of     Glucantime in combination with systemic Glucantime in the treatment of ACL parasitologically     proven patients will be evaluated. The clinical trial will be carried out according to the     International approved GCP (Good Clinical Practice) guide lines.   "
243793|NCT01050790|"     RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer     cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways     to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. An autologous stem cell transplant may be able to replace blood-forming cells that     were destroyed by lenalidomide and azacitidine. Giving autologous lymphocytes after the     transplant may help destroy any remaining cancer cells.      PURPOSE: This pilot trial is studying how well giving lenalidomide together with azacitidine     works when followed by autologous stem cell transplant and autologous lymphocyte infusion in     treating patients with multiple myeloma.   "
243794|NCT01050803|"     To evaluate the effectiveness of the Farsi diabetes self-management education program on     psychosocial, lifestyle, and clinical measures in people with newly diagnosed people with     type 2 diabetes and those with already-diagnosed type two diabetes who had received little     self-management education. The development of the program was guided by an innovative process     of intervention planning: Intervention Mapping.   "
243795|NCT01050816|"     An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage     defect patients who are appropriate for the trial, and evaluating the validity and safety for     12 months.   "
243796|NCT01050829|"     The purpose of the study is to look at the safety (what are the side effects) and efficacy     (how well does it work) of gadobutrol when used for taking MR images of the body/extremities     regions. The results of the MRI with gadobutrol injection will be compared to the results of     MR images taken without contrast and with the results of the MR images taken with Magnevist.   "
243841|NCT01051414|"     To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032     for 24 weeks treatment.   "
243797|NCT01050842|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such     as bicalutamide, may lessen the amount of androgens made by the body. Selective estrogen     receptor modulators, such as raloxifene, may work together with bicalutamide to stop the     growth of prostate cancer.      PURPOSE: This clinical trial studies giving bicalutamide and raloxifene together in treating     patients with metastatic or hormone-refractory prostate cancer.   "
243798|NCT01050855|"     This is a Phase II pilot study to evaluate engraftment and toxicity of patients with     non-malignant diseases using a reduced intensity conditioning regimen in the setting of     allogeneic transplant for non malignant diseases. Bone Marrow or cord blood will be     acceptable as a stem cell source.      Recently, reduced intensity conditioning (RIC) regimens have been used for both adult     patients with leukemias and pediatric patients with non-malignant diseases. These regimens     are better tolerated, resulting in less transplant related morbidity and mortality. Stable     mixed chimerism, while insufficient for eradication of leukemias, may be sufficient to cure     patients with non-malignant diseases.   "
243799|NCT01050868|"     This prospective, non-randomized, non-controlled, interventional study will determine whether     the Roche automated bolus caclulator (ABC) reduces post-meal hyperglycemia better than the     competitor's ABC without causing significant hypoglycemia.   "
243800|NCT01050881|"     Each year around 200 blood donors in the UK are found to be infected with blood-borne     diseases (HIV, hepatitis B, hepatitis C, and HTLV), while several others have been identified     as having an increased risk of variant Creutzfeldt-Jakob Disease (vCJD). Although the     notification procedures for these infections vary, their effectiveness and appropriateness     have never been evaluated in a systematic study.      The proposed research has been designed to assess the responses of blood donors to     notification and their satisfaction with how they were informed about the infection. The     study will be implemented using standard questionnaire-based measures (French et al, 2004;     Marteau & Bekker, 1992).      The study will involve approximately 600 blood donors who were informed of an infection or     possible infection with blood-borne diseases in 2008 and 2009, and approximately 100 donors     notified of possible risk of vCJD infection in 2005. A comparable group of 2005 donors will     be included to control for the effects of time. As the majority of donors testing positive     donated to NHS Blood and Transplant (NHSBT), the participants will be identified from the     NHSBT database only, and their availability confirmed through their GP or specialist     clinician. A standardized questionnaire will be then sent to all those identified as     eligible.      The study will last 12 months, but direct participant involvement will be limited to the time     required to complete the questionnaire, which should take under one hour. To safeguard     confidentiality, no identifiable personal data will be used in the analysis. Where     demographic or medical information already held by NHSBT is retrieved to minimise response     burden, this will be pseudonymised before use.      The study is sponsored by the blood services for England, Wales, Scotland and Northern     Ireland. The results will be used to inform notification procedures in the future.   "
243801|NCT01050894|"     This is a feasibility study to determine if anti-inflammatory cytokines can be concentrated     from patients with osteoarthritis.   "
243802|NCT01050907|"     The purpose of this Treatment IND is to make miltefosine available for mucocutaneous     leishmaniasis patients presenting in the United States.      If entrance criteria are met, subjects with mucosal or cutaneous leishmaniasis will receive     miltefosine at a targeted dose of 2.5 mg/kg/day for 28 days. During treatment at weeks 1, 2,     and 4, the patient will return to the treatment facility to be assessed for adverse events.     Blood for transaminase and creatinine values will be drawn at the midpoint and at the end of     therapy.      Patients will return to the treatment facility to be examined clinically at 6 wks (ie, 2 wks     after the end of therapy), 3 months (2 months after therapy), and 7 months (6 months after     treatment) for ML and CL patients, and also at 13 months (12 months after treatment) for ML     patients.   "
243803|NCT01050920|"     Warfarin is a commonly used anti-coagulant, but has a narrow therapeutic index and wide     inter-individual and inter-ethnic variation in dose requirements. Several genetic and     non-genetic factors have been identified that could influence warfarin dose requirements.     However, current known predictive factors could only explain about 50-60% of warfarin dose     variability. Inter-ethnic differences in genetic influences on warfarin dose requirements     also exist. We hypothesize that genetic factors other than CYP2C9 and VKORC1 may influence     warfarin dosing and serve to further optimize warfarin dosing.   "
243804|NCT01050933|"     Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care     problem. It normally occurs in all patients after surgery to the abdomen but in some cases     can result in serious complications. The objective of this study is to determine if inhaling     very low doses of carbon monoxide (CO) before and after colon surgery will shorten the     duration of normal POI and/or prevent the development of POI complications in patients     undergoing colon surgery.      This preliminary study will be conducted in ten healthy volunteers to monitor for blood     levels and adverse effects that occur at different durations of exposure of inhaled CO to     establish a safe dose for patients in the main trial. For the main trial, patients requiring     surgery to their colon will be assigned randomly to receive one hour treatments of either CO     or oxygen by face mask before and after their operation.      We hypothesize that healthy volunteers will be able to tolerate 1 hour doses of 250 ppm of CO     with minimal side effects. It is also anticipated that for each dose of CO administered, the     blood levels of CO will remain well under poisonous levels. Finally, we anticipate blood     levels of CO will return to baseline level within 24 hours following the last dose of CO.   "
243820|NCT01051141|"     The Emergency Department (ED) setting is a unique point of access for reaching underage     drinkers (age 14-20). With the aid of computer technology, this study will screen underage     drinkers in the ED and fully test promising ED-based brief intervention and 3-month follow-up     brief treatment approaches for alcohol misuse. Developing methods to efficiently and     effectively optimize these approaches has powerful public health implications for improving     outcomes for underage drinkers.   "
243805|NCT01050946|"     This study is a means of providing transplantation to those patients who would be a stem cell     transplant candidate who do not have an appropriate donor.      The use of CD34 selected haploidentical donor with an umbilical cord unit may help provide     earlier engraftment without the need for long term immunosuppression.      This study tests a new method of bone marrow transplantation called combined     haploidentical-cord blood transplantation. In this procedure, some of the blood forming cells     (the stem cells) from a partially human leukocyte antigen (HLA) matched (haploidentical)     related donor are collected from the blood, as well as cells from an umbilical cord are     transplanted into the patient (the recipient) after administration of a conditioning     regimen. A conditioning regimen consists of chemotherapy and sometimes radiation to the     entire body (total body irradiation, or TBI), which is meant to destroy the cancer cells and     suppress the recipient's immune system to allow the transplanted cells to take (grow).   "
243806|NCT01050959|"     The purpose of this compassionate use study is to provide clinical and technical support of     the Bion® microstimulator system to the subjects who have decided to keep the system for     relief of headache symptoms that have not responded to medical treatment. These study     subjects were enrolled and implanted with the Bion® system during a previous clinical     investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.   "
243807|NCT01050972|"     This study is an interventional trial to evaluate the effectiveness of a cognitive and     physical program (Intervention), in reducing the frequency of head and neck pain in the     population of an extensive territory of Italy.   "
243808|NCT01050985|"     This study is for people with advanced cancer for which no curative treatment exists.      The purpose of this study is to test the safety and effectiveness of the combination of the     drugs Temsirolimus and Capecitabine and see what effects it has on cancer.      Temsirolimus is a drug that is given by vein that targets a protein important for the growth     of cancer cells known as mTOR. By inhibiting this protein, Temsirolimus can inhibit cancer     cell growth and even lead to their death.      Capecitabine is a more traditional chemotherapy. It is an oral pill that gets converted in     the body to the very common chemotherapy known as 5-fluorouracil.      This research is being done because it is not known if the combination of Temsirolimus and     Capecitabine will work better than Capecitabine or Temsirolimus alone.   "
243809|NCT01050998|"     The primary objectives of this study is to assess the safety, tolerability and efficacy of     multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with     moderately active Rheumatoid Arthritis (RA).   "
243810|NCT01051011|"     This randomized, open-label, parallel arm study will compare the safety, tolerability and     effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients     with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea     combination therapy. Patients will be randomized to receive either taspoglutide 10mg     subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc     weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin     treatment will be continued in all patients throughout the study, whereas sulfonylurea will     be discontinued before starting study treatment. Anticipated time on study treatment is 24     weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample     size is 500-600 patients.   "
243811|NCT01051024|"     The purpose of this study is to assess the efficacy of Diamel administration in the treatment     of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3     clinical trial will be 24 weeks.   "
243812|NCT01051037|"     The purpose of this study is to demonstrate that combined stereotactic body radiotherapy and     radiofrequency ablation is safe for patients with lung tumors near central airways.   "
243813|NCT01051050|"     The goal of this study is to improve surgical residents' skills in critically appraising the     literature and to promote the dissemination and application of the best available evidence to     surgical practice. The hypothesis is that mandatory participation, with faculty oversight, in     a journal club wiki will improve the dissemination, evaluation, and application of     evidence-based medicine (EBM) in a surgical residency program at University of Texas Health     Science Center at Houston (UT-Houston).   "
243814|NCT01051063|"     The purpose of this study is to evaluate the clinical activity and safety of a WT1     Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-induction therapy in adult     patients with WT1-positive AML presenting a suboptimal clinical response to induction     chemotherapy. The study will also assess whether this treatment induces a specific immune     response to the malignancy.   "
243815|NCT01051076|"     The purpose of this study is to evaluate whether a concentrate containing both FVIII and von     Willebrand Factor (VWF) given at a high dose will induce immune tolerance in subjects who     have already experienced and failed ITI with VWF-free FVIII concentrates. The treatment on     this study is expected to last up to 33 months.   "
243816|NCT01051089|"     The study is a randomized controlled study comparing the metabolic effect of a 3 month     intensive lifestyle modification intervention in Korean type 2 diabetic patients.   "
243817|NCT01051102|"     This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood     sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese     subjects with type 1 diabetes. Each subject will be randomised to one of the two possible     treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic     insulin aspart 30 followed by NN5401).   "
243818|NCT01051115|"     Patients with chemo refractory CLL have a poor prognosis. 2 independent mechanisms are     attributed to the development of chemoresistance in CLL. The first is a shift in the balance     between pro- and anti-apoptotic regulators. The second mechanism is based on acquired     mutations resulting in a dysfunctional p53 response. Recent studies indicate that the     tyrosine kinase inhibitor dasatinib acts synergistically with both purine analogies and     alkylating agents. Also, dasatinib has the potency to restore the apoptotic balance of CLL     cells.      Hypothesis: Dasatinib will be clinically active in chemo-refractory CLL patients and will act     synergistically with the purine-analogue fludarabine.   "
243819|NCT01051128|"     The purpose of this clinical investigation is to demonstrate product performance of the     Prometra Programmable Pump System in the delivery of intrathecal Lioresal® (baclofen) for the     management of severe spasticity.   "
243824|NCT01051193|"     This study is designed to provide long term safety data of TRI476 in children with     inadequately-controlled partial seizures. This study is conducted in patients who complete     the core study CTRI476B1301. Blinding is maintained during the transition and dose adjustment     phase of the extension study. All patients are treated with TRI476 from the dose adjustment     phase onwards. The purpose of study is to confirm that TRI476 as adjunctive therapy is safe.   "
243825|NCT01051206|"     HES 130/0.4 significantly solution will not affect on coagulation and blood loss in patients     medicated with antiplatelet agents prior to off-pump coronary bypass surgery (OPCAB).   "
243906|NCT01052285|"     The purpose of this study is to determine whether Transversus abdominis plane block is     superior to placebo or superior to local infiltration in analgesic efficacy after groin     hernia repair.   "
243907|NCT01052298|"     Objectives of the study are to investigate the safety, tolerability and levels of     ciprofloxacin in the lung after single and multiple inhalative administration to patients     with mild to moderate COPD (stage I-II according to GOLD Criteria).   "
243826|NCT01051219|"     This is a randomized, controlled trial to determine whether Losartan is effective at slowing     down, halting or reversing liver fibrosis in patients with non-alcoholic steatohepatitis     (NASH). Liver fibrosis is the accumulation of tough, fibrous scar tissue in the liver which     occurs in patients with NASH. NASH resembles alcoholic liver disease, but occurs in people     who drink little or no alcohol. The major feature in NASH is fat in the liver, along with     inflammation and damage, which may lead to cirrhosis, in which the liver is permanently     damaged and scarred and no longer able to function properly.      Primary hypothesis:      That losartan is superior to placebo in reversing, slowing down or halting fibrosis in     patients with non-alcoholic fatty liver disease, after 24 months of treatment.      Secondary hypothesis:        1. That the safety profile of the angiotensin receptor blocker (losartan) in this patient          population is acceptable        2. That losartan can prevent clinical deterioration in non-alcoholic fatty liver disease        3. That serum, radiological and histological markers of fibrosis correlate in these          patients over a 24 month period   "
243827|NCT01051232|"     A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy     volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western     population.   "
243828|NCT01051245|"     The purpose of this study is to determine whether case management for type 2 diabetic     patients with target-organ damage improves quality of care compared to usual care.   "
243829|NCT01051258|"     The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in     patients with advanced emphysema.   "
243830|NCT01051271|"     ABSTRACT      Study Objective:      To compare the effects of midazolam and diphenhydramine for the prevention of metoclopramide     induced akathisia.      Methods:      This randomized, double-blind and controlled trial aimed to investigate co-administered     midazolam versus diphenhydramine in the prophylaxis of metoclopramide induced akathisia.     Patients 18 through 65 years of age who presented to the ED with primary or secondary     complaints of nausea and/or moderate to severe vascular type headache were eligible for this     study. Patients were randomized to one of the fallowing three groups: (1) metoclopramide 10     mg + midazolam 1.5 mg (2) metoclopramide 10 mg + diphenhydramine 20 mg (3) metoclopramide 10     mg + placebo. Metoclopramide was administered as a 2 minutes bolus infusion. Midazolam,     diphenhydramine and normal saline solution administered as a 15 minutes slow infusion. Whole     procedure was observed, akathisia and sedation scores and vital changes were recorded.   "
243831|NCT01051284|"     People with pancreatic cancer that cannot be cured by surgery are being asked to participate     in this study.      The purpose of this study is to test the ability of the radiation oncologists to administer     Cyberknife therapy along with Gemcitabine chemotherapy for patients with pancreatic cancer.     Radiation and Gemcitabine are both effective at killing cancer cells but they generally     cannot be given at the same time. Cyberknife therapy is highly focused radiation that is     being used extensively at Georgetown University and around the United States to treat a     number of cancers. It is believed that because Cyberknife is so highly focused it can be     given safely with regular doses of chemotherapy to attack cancer cells in two ways at the     same time.      This research is being done because it is not known if using Cyberknife with chemotherapy     will be a safe way to treat pancreatic cancer.   "
243832|NCT01051297|"     There is a clear link between obstructive sleep apnea (OSA) and cardiovascular disease.     However, there has been no clear link between OSA and venous thromboembolism (VTE). The     objective of this study is to evaluate such a link.   "
243833|NCT01051310|"     The proposed investigation is a prospective, multicenter, non-randomized study to evaluate     the immediate benefits (at discharge and at 30 days) in terms of performance and safety of     the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis. In     addition, the study aims to evaluate the performance and the safety of the implantation of     the Medtronic CoreValve PAV in a failing aortic bioprosthesis at subsequent annual follow-ups     out to 48 months post procedure.      These objectives will be achieved through the following endpoints:        -  Primary safety endpoint - Composite of Major Adverse Events        -  Primary performance endpoint - Technical and procedural success at discharge      Patient Population: Eligible subjects will be at least 75 years old, presenting with a     failing aortic bioprosthesis (stenotic, incompetent or mixed) including homograft or stented     or stentless heterograft, considered poor surgical candidates and necessitating repeat aortic     valve replacement. Up to 20 patients will be included in up to four hospitals.   "
243834|NCT01051323|"     This observational study will investigate hemoglobin levels and Mircera (methoxy     polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and     compare standards of care between centers. Data from each patient will be collected over 12     months of Mircera therapy.   "
243835|NCT01051336|"     The aim of this protocol is to evaluate the tolerability of the Taris placebo system for the     development program and to provide key safety and tolerability data for the Taris platform.   "
243836|NCT01051349|"     Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield     Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple     sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP     and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS)     relapse, slowing disability progression, and reducing new MS lesion formation in this study     population.   "
243837|NCT01051362|"     This Phase II study is to explore the efficacy and toxicity of Pegylated liposomal     doxorubicin and Carboplatin in patients with previously untreated non-small cell lung cancer     (NSCLC) not amenable to radiotherapy or surgical treatment. The planned enrollment for this     trial is 48 patients (including a 10% rate for inevaluable patients).   "
243838|NCT01051375|"     The current application targets patient education and enablement, implementation of best     practices, continuity of care, and an improvement model to improve efficiencies by     investigating whether a brief targeted intervention prior to the first formal ED assessment     is efficacious in altering outcome and treatment course.   "
243839|NCT01051388|"     The aim of this study is to evaluate the efficacy of proton pump inhibitor (PPI), comparing     to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal     ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular     protection.   "
243842|NCT01051427|"     This is a blind trial to test if Surgiflo is effective in posterior epistaxis. After the     investigators see than anterior tamponade is not effective stopping epistaxis, the     investigators try using Surgiflo and if it does not work the investigators continue with a     nasal catheter. This is the usual way to stop nasal bleeding, but is painful and has serious     after-effects in the nose. Surgiflo is a hemostatic matrix that can be put into the nose,     painlessly and easily. So the investigators think it can be useful controlling nasal     bleeding, so the investigators could avoid to put nasal catheters in these patients.   "
243843|NCT01051440|"     There have been reports that stimulants may be effective for bipolar depression without     triggering mania. This study will examine whether lisdexamfetamine can improve depressive     symptoms over the course of eight weeks. Lisdexamfetamine is a prodrug stimulant that is     currently approved for attention deficit hyperactivity disorder (ADHD). Participants take the     study drug or placebo in addition to a mood stabilizer. The study includes functional     magnetic resonance imaging and magnetic resonance spectroscopy to determine whether the     medication alters the response to affective stimuli or glutamate, glutamine, or gamma     aminobutyric acid (GABA) levels. Neuropsychological testing is also included to determine     whether the study drug improves memory and attention in this population. The primary     hypothesis is that lisdexamfetamine is clinically effective in this population. The secondary     hypothesis is that it will result in an increased response to affective stimuli and altered     neurotransmitter levels in the anterior cingulate cortex.   "
243844|NCT01051466|"     Previous research studies have shown that depression is associated with changes in structure     and activity in different parts of the brain and that antidepressant medication can affect     brain activity in different parts of the brain in individuals suffering from depression. The     primary purpose of the study is to find out more about how the antidepressant medication     duloxetine affects brain activity and structure in individuals with depression.   "
243845|NCT01051479|"     The purpose of this study is to evaluate the investigators ability to obtain reliable and     meaningful 11C-Choline PET-CT images of esophageal cancer.   "
243846|NCT01051492|"     Breast cancer is a common malignancy world-wide, and is the commonest female malignancy in     Singapore, with rising trends in incidence over the last 2 decades. While there have been     improvements in treatment, mortality from breast cancer remains significant. Development of     biomarkers to predict treatment response and toxicity to anti-cancer agents can rationalize     the choice of therapy for the individual patients to optimize treatment outcome and to reduce     unnecessary toxicities. Development of novel therapies or novel approaches to therapy is also     critical to improve the treatment armamentarium in breast cancer. These research strategies     will have an significant impact on breast cancer treatment both in Singapore as well as     globally.   "
243847|NCT01051505|"     The purpose of this study is to explore the safety and tolerability of AZD5069 at     steady-state, following twice a day oral dosing in healthy subjects.      AZD5069 is being developed by AstraZeneca and this study is being carried out on behalf of     the sponsor by Quintiles Drug Research Unit at Guy's Hospital, London. This is the second     time that AZD5069 will be administered to humans in clinical trials. We are conducting this     study to determine whether AZD5069 is safe and well tolerated by healthy males and females at     different dose levels over an 8-day dosing period. We will also be studying how quickly     AZD5069 is absorbed into and cleared by the body. It is planned that there will be up to 3     dose groups in the study and each group will consist of up to 12 volunteers, with 9 receiving     the active drug and 3 receiving placebo. The study involves 3 visits over approximately 8     weeks, and will include 1 residential visit lasting 10 nights and a follow up.   "
243848|NCT01051518|"     The investigation concerns a prospective, multicenter, single arm safety and performance     study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with     symptomatic aortic native valve stenosis necessitating valve replacement which are considered     poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and     the cardiologist are recruited in the study.      Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve     performance and placement will be followed up at 3 and 6 months post-procedure. Further     long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months     post-procedure.   "
243849|NCT01051531|"     The purpose of the study is to evaluate the safety, tolerability and treatment response of     paliperidone palmitate administered as once-monthly injections to patients with     schizophrenia.   "
243850|NCT01051544|"     This is a prospective, controlled, randomized, open label study, aimed at comparing FVIII/VWF     concentrates with FVIII concentrates at 200 IU/kg daily in their ability to induce immune     tolerance in Haemophilia A patients with high responding inhibitors and poor prognosis for     success.   "
243851|NCT01051557|"     This phase I/II trial studies the side effects and best dose of temsirolimus when given     together with perifosine and to see how well it works in treating patients with recurrent or     progressive malignant glioma. Temsirolimus may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as perifosine,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving temsirolimus with perifosine may be an effective     treatment for malignant glioma.   "
243852|NCT01051570|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and prednisone, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Giving carboplatin together     with everolimus and prednisone may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving carboplatin together with everolimus     and prednisone works in treating patients with metastatic prostate cancer that progressed     after docetaxel.   "
243853|NCT01051583|"     Assess the efficacy of Avastin as an adjunct to Diode Laser cyclophotocoagulation in the     treatment of Neovascular Glaucoma.   "
243918|NCT01052441|"     The purpose of the study is to evaluate diagnostic performance of high iodine (iopamidol 370     mg/dl) content versus low iodine (iodixanol 300 mg/dl) content for diagnostic accuracy by     contrast-enhanced Coronary Cardiac Computed Tomography (CCTA) using a 64-detector-row CT     scanner for detection of presence or absence of coronary artery obstruction when compared     against invasive coronary angiography, the standard of truth.   "
243854|NCT01051596|"     People with colorectal cancer that cannot be cured by surgery are being asked to participate     in this study.      The purpose of this study is to test the efficacy (effectiveness) of a new combination of     drugs, ABT-888 and temozolomide for patients with colorectal cancer. Temozolomide acts by     damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells.     ABT-888 inhibits an enzyme called PARP which helps to fix damaged DNA. By inhibiting this     enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide,     and will hopefully increase the killing of cancer cells, and decrease the tumors in the body.      ABT-888 is an investigational or experimental anti-cancer agent that has not yet been     approved by the Food and Drug Administration (FDA) for use in colorectal cancer.      This study will help find out what effects (good and bad) the combination of drugs,     temozolomide and ABT-888 has on colorectal cancer.      This research is being done because it is not known if ABT-888 will increase the     effectiveness of temozolomide for colorectal cancer.   "
243855|NCT01051609|"     The purpose of this study is to compare pre and post Aromatase Inhibitor (AI) treatment     serological markers of inflammation and assess for correlation with AI-MS.   "
243856|NCT01051622|"     Using scintigraphic imaging including planar scintigraphy and SPECT, this study will evaluate     the utility of two different ex vivo 99mTc-HMPAO labelled mononuclear cell populations in     order to select the optimal methodology (using PBMC or purified lymphocyte subpopulations)     for future drug intervention studies in Crohn's disease.      Two parallel exploratory approaches will be investigated to enrich for lymphocyte populations     expressing leukocyte trafficking inhibitors. In the first, whole blood will be fractionated     on a ficoll gradient to purify a heterogeneous population of all the peripheral blood     mononuclear cells (PBMC) for labelling. Secondly, further enrichment will be attempted using     depletion of PBMC fractions of monocytes and B cells.   "
243857|NCT01051635|"     Background:        -  Indenoisoquinolines are experimental cancer treatment drugs that damage the DNA in          cells, resulting in cell death. Researchers have been studying these drugs and their          usefulness in treating types of cancer that have not responded well to standard          therapies like surgery or radiation.        -  LMP400 (NSC 743400) and LMP776 (NSC 725776) are indenoisoquinolines that have not been          given to cancer patients before. These drugs have very similar chemical structures and          work the same way, but researchers do not know which one will work best. More          information is needed about how LMP400 and LMP776 are processed by the body and how          effective they are in treating difficult-to-treat types of cancer.      Objectives:        -  To determine the maximum tolerated dose of LMP400 (NSC 743400) and LMP776 (NSC 725776).        -  To study how the body handles LMP400 and LMP776.        -  To evaluate the effectiveness of LMP400 and LMP776 as a treatment for tumors and          lymphoma that have not responded to standard treatment.      Eligibility:      - Individuals at least 18 years of age who have malignant solid tumors or Hodgkin s     disease/non-Hodgkin lymphoma that has not responded to standard therapies.      Design:        -  Participants will receive either LMP400 or LMP776. The treatment cycle will be 28 days.          On the first 5 days of each cycle, participants will receive intravenous doses of their          specific study drug, followed by 23 days without the drug. The 28-day cycle will be          repeated as long as the drug does not cause severe side effects and the cancer remains          stable or improves. The study doctor may increase or decrease the dose of study drug          depending on how well it is tolerated.        -  Blood, urine, and hair samples and skin and tumor biopsies will be collected during the          first treatment cycle. Routine blood samples will be taken throughout the study.        -  Other tests, including additional blood and urine samples, computed tomography (CT) or          other scans, and bone marrow samples, may be performed as directed by the study          doctors....   "
243858|NCT01051648|"     Injecting Triamcinolone acetenoide for visualizing and removing vitreous from the anterior     chamber.   "
243859|NCT01051661|"     The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1     flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years     of age.   "
243860|NCT01051674|"     Using a 2x2 complete factorial design, approximately 140 obese men and women who may or may     not have type 2 diabetes will be randomized to one of two conditions (70 in each condition):     (a) a high fiber diet, or (b) a low-carbohydrate diet. Participants will be instructed to     follow their assigned diets for 1 year. Outcome measures of interest will include     participants' BMI, waist circumference, blood lipids (total, HDL, and LDL cholesterol, and     triglycerides), C-reactive protein, and gastrointestinal peptides. Participants will be     recruited from the Loma Linda and San Bernardino city area in southern California.   "
243861|NCT01051687|"     Background: New light shed on the cholinergic aspects of vitiligo pathophysiology. It was     found that acetylcholine concentration increased with a significantly reduced expression of     acetylcholinesterase in vitiliginous patches that return to normal up on repigmentation.      Objective: The investigators will undertook this controlled, prospective pilot study to     evaluate the efficacy and safety of botulinum toxin A in patients with localized vitiligo.      Methods: 10 patients with focal or segmental vitiligo will be recruited. For each patient     with focal vitiligo, one or two vitiliginous patches will be treated. The other patches will     be used as control. For each patient with segmental vitiligo, half of the lesion will be     treated. The other half will be used as a control. Botulinum toxin will be injected. The     response will be analyzed at the initial visit, two weeks and at two and six months after     therapy.   "
243862|NCT01051700|"     This study is to evaluate the safety, absorption rate and side effects associated with the     study drug. Healthy volunteers will be given a single dose of the drug in Part 1. Subjects     will be dosed at the same time at several different sites. In Part 2 of the study elderly     volunteers will participate in a 14 day repeat dose session receiving either study drug or a     placebo (sugar pill). Data from at least 7 days of safety will be reviewed from the first set     of volunteers before increasing the doses for the next set. All results will be used for     planning the next study.   "
243876|NCT01051882|"     The study will evaluate the safety, tolerability and therapeutic effects (preliminary     efficacy) of injection of autologous cultured mesenchymal bone marrow stromal cells secreting     neurotrophic factors (MSC-NTF), as a possible treatment for patients with Amyotrophic Lateral     Sclerosis (ALS) at the early and progressive disease stages.   "
243877|NCT01051895|"     This trial will compare HPV testing to the routine colposcopy in the follow-up of women     treated for cervical high grade lesions. Women will be assigned randomly (by chance) after     treatment of cervical pre-cancer to be either (1) followed-up by colposcopy, or (2) undergo     HPV testing. Women found to have disease by either strategy will be offered re-treatment. For     the next 2 years participants will undergo yearly, in depth, evaluation to assess the cervix     for precancer. We will then be able to compare which of the 2 follow-up strategies worked     best.   "
243878|NCT01051921|"     The purpose of this study is to determine if the combination treatment of CTS-1027, pegylated     interferon and ribavirin can improve the response rates in HCV patients who did not     previously respond to pegylated interferon and ribavirin therapy.   "
243863|NCT01051713|"     The ENGAGED study is a 12-month randomized controlled trial investigating different     strategies to improve weight loss in overweight individuals. All participants will receive an     effective weight loss treatment: either self-guided or group formats. All treatment will be     provided in the Department of Preventive Medicine at Northwestern University. Participants     who receive the self-guided weight loss treatment will be provided with a weight loss manual     that contains proven behavioral weight loss strategies. Those participants who receive the     group treatment will take part in 8 weekly, 90 minute group sessions in our clinic at 680 N.     Lakeshore Dr., Chicago, IL 60048. Some participants will also be assigned an individual     coach, who will communicate with them regularly via phone, email, and/or text message for the     duration of the study. All participants must be willing and able to record food and beverage     intake (either on a smartphone or on paper) and be willing to wear a small and unobtrusive     physical activity measurement device for the first six-months of the study. Additionally, all     participants will be asked to attend 3 follow-up assessment visits at our clinic at months 3,     6 and 12 after the study begins. Participants will be compensated for completing each of the     3 follow-up assessments. All participants will be part of a team weight loss competition at 3     and 6 months with financial incentive to be split evenly among the winning team.   "
243864|NCT01051726|"     Aromatherapy is a form of complementary medicine that uses scented materials known as     essential oils for the purpose of affecting a person's health or mood. Although aromatherapy     has been used in childbirth for centuries, there are no high-quality studies examining     whether the treatment works.      Methodology      We would like to see if aromatherapy affects a woman's experience of childbirth by lowering     associated anxiety and pain. Consenting participants will be randomly allocated to one of     these groups:        1. Aromatherapy oils (e.g. clary sage, peppermint, lavender, frankincense)        2. Non-essential oil (baby oil)        3. Standard maternity care      We will gather primary data, e.g. if she's been in labour before and her awareness of     complementary medicine. We will also conduct the Spielberger State-Trait Anxiety Inventory     with her, and provide her with the oil and swab if she is in groups 1 or 2 with instructions     to keep the swab with the oil on it near to her. She can also put more oil on the swab as she     requires.      Postnatally, data will be collected from her notes regarding pain relief used, duration of     labour, augmentation of labour, and any other medical interventions of note. We will also     complete the anxiety scale with her once more. Before her discharge we ask the mother for any     comments regarding her experience of the labour. The results from all three cohorts will then     be compared. There will also be opportunity for the midwife to make any comments regarding     his/her perception of the participant's labour. Finally we will hold a focus group with     midwives regarding the practicalities for implementation of aromatherapy in maternity care   "
243865|NCT01051739|"     Improved Assessment of Visual Field Change is a trial aimed at investigating mechanisms of     visual field testing variability. The investigators have found using larger stimulus size     substantially lowers short-term variability. In this study, the investigators will determine     if larger stimuli detect visual field change at an earlier time. The investigators are also     developing a statistical model that accounts for correlations of neighboring test locations.   "
243866|NCT01051752|"     A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are     evaluated in a cohort of patients with NTM diseases.   "
243867|NCT01051765|"     Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be     effective and safe in western studies. Different with westerns, squamous carcinoma is the     main pathological type in china patients. The investigators then initiated a prospective     phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced     esophageal carcinoma to observe the efficacy and safety of the combination.   "
243868|NCT01051778|"     The aim of this study is to compare the efficacy and safety of Low molecular weight heparin     (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with     recurrent pregnancy loss associated with antiphospholipid syndrome (APS).   "
243869|NCT01051791|"     To carry out exploratory studies to determine if activity of this regimen correlates with     tumor and patient associated markers of the EGF-R/mTOR pathway These markers may correlate     with activity of this regimen and provide exploratory insights in to the mechanism of this     treatment approach.      Expression of the pathway components including EGF-R and phosphorylated EGF-R (p-EGF-R), ERK     and p-ERK, Akt and p-Akt(T308 and S473), p70s6k and p-p70s6k, S6 and p-S6, HIF-1-alpha, p27     and 4E-BP1 will be assessed. Mutation and FISH analysis for EGF-R expression will also be     performed on tumor samples. Biopsies will be obtained at the following times: pre-treatment,     and after 4 weeks (one cycle) of treatment. If available, original diagnostic tissue may be     submitted in place of the pre-treatment biopsy.   "
243870|NCT01051804|"     Comparison of two contact lens solutions.   "
243871|NCT01051817|"     A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of     multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI     scans over a 24 week period in patients with relapsing-remitting multiple sclerosis   "
243872|NCT01051830|"     The purpose of this study is to 1) develop a well-conceived and feasible protocol for     hospital discharge and subacute care for hip-fractured elderly persons with DM, and 2)     compare the costs and effectiveness of this DM-specific model with those of an effective     subacute care model previously developed by our research team.   "
243873|NCT01051843|"     The purpose of this study is to identify the orofacial difficulties during the maternal     breastfeeding in rooming-in.   "
243874|NCT01051856|"     The purpose of this research study is to find a lowest leak rate following a distal     pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to     have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the     pancreas). Two FDA cleared devices (TissueLink and SEAMGUARD) will be studied to treat and     prevent leaks at the end of the pancreas.   "
243875|NCT01051869|"     Both simple decompression and anterior transposition of the elbow nerve (ulnar nerve) for     acute displaced fractures of the elbow (distal humerus) treated with plate fixation are     currently used by surgeons. We want to examine which treatment will overall give better     results in regards to arm function and residual pain.   "
243892|NCT01052103|"     The purpose of this study is to determine whether LY2140023, when added to standard-of-care     antipsychotic treatment, will improve negative symptoms.   "
243879|NCT01051934|"     Background:        -  Advanced cases of non-small-cell lung carcinoma (NSCLC) usually are not successfully          treated with standard therapies. Even treatments that attempt to specifically target          NSCLC cells have not proved effective.        -  Researchers are interested in determining whether a combination of the chemotherapy          drugs SS1 (dsFv) PE38, paclitaxel, carboplatin, and bevacizumab may be effective in          shrinking the size of NSCLC tumors. Three of the drugs (paclitaxel, carboplatin, and          bevacizumab) are commercially available, while the other is a drug that is currently          being tested to determine its usefulness in cancer treatment. This study will help to          determine if the combination of all four drugs is more effective and as safe, safer, or          less safe than other drug combinations given to treat NSCLC.      Objectives:      - To determine a safe and tolerable dose for the combination of SS1 (dsFv) PE38 with     paclitaxel, carboplatin, and bevacizumab in patients with advanced mesothelin-expressing lung     adenocarcinoma.      Eligibility:        -  Age > 18 years of age        -  Newly diagnosed advanced non-small-cell lung carcinoma        -  No prior chemotherapy for lung cancer        -  Individuals at least 18 years of age who have advanced non-small-cell lung carcinoma          that has not responded to standard treatments.      Design:        -  The study will last for two 21-day cycles of treatment for the four-drug combination,          with additional treatment cycles of carboplatin, paclitaxel, and bevacizumab.        -  Two to three weeks prior to the study, participants will be screened with a full medical          history and physical exam, bone marrow biopsy (we do not do bone marrow biopsies) (if          one has not been performed in the last 6 months), computed tomography (CT) or ultrasound          scan, tumor measurements, and other tests as required by the researchers. Participants          will provide blood and urine samples at this time as well.        -  During the study, participants will receive SS1 (dsFv) PE38, carboplatin, paclitaxel,          and bevacizumab for a maximum of two cycles. On Day 15 of the first cycle, participants          will provide a blood sample to be tested to see if SS1 (dsFv) PE38 is being effective.          If the tests show that SS1 (dsFv) PE38 is not effective, participants will not receive          another dose of it, but will continue to receive paclitaxel, carboplatin, and          bevacizumab for the second cycle.        -  After the first two cycles, participants will continue to receive carboplatin,          paclitaxel, and bevacizumab every 3 weeks for up t...   "
243880|NCT01051947|"     A randomized, cross-over, single-blind study to compare the effects of nebivolol and     metoprolol on central aortic pressure and peripheral brachial pressure in patients with     stable cardiovascular disease.   "
243881|NCT01051960|"     The purpose of this study is to determine the clinical characteristics and hemodynamic     profiles that predict exercise induced pulmonary hypertension in 15 patients with systemic     sclerosis. The study also aims to determine the effectiveness of Ambrisentan for subjects     with exercise induced Pulmonary Arterial Hypertension (PAH) with scleroderma   "
243882|NCT01051973|"     The study aims to compare two manualized treatments. They are based on cognitive behavior     therapy or stress management. Both treatments are delivered via an internet application and     the patients' work with the treatments is supported through online contact with a therapist.     The treatments last for 10 weeks.      Approximately 200 patients will be included in the study and randomized to either condition.      The study hypothesis is that CBT will be superior to stress management on the main outcome     measure, which is IBS symptom severity measured over 4 weeks.   "
243883|NCT01051986|"     The purpose of this study is to compare early and 1-year graft patency rates of saphenous     vein composite grafts with those of right internal thoracic artery composite graft and     mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass     grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no     touch technique and used as composite graft.   "
243884|NCT01051999|"     Patients with cystic fibrosis develop frequent and potentially life-threatening lung     infections. Recent studies suggest that the nutrient glutamine may help the body fight off     infection. Glutamine is an amino acid; a type of nutrient the body requires to build muscle.     It is one of the building blocks of protein. During an illness, blood levels of glutamine     tend to be lower than normal. Also, many patients with cystic fibrosis have difficulty     getting normal levels of nutrients from food. The aim of this study is to see if patients     with cystic fibrosis have low levels of glutamine when they experience an infection, and     whether a dietary glutamine supplement taken daily for three months can raise these levels.     We also want to see if this supplement can improve other blood markers of immunity (the     body's ability to defend itself from infection). We hope to enroll 40 people with cystic     fibrosis who experience a lung infection, over a one year period, into this study.   "
243885|NCT01052012|"     This is a research study testing SABER™-Bupivacaine (an experimental pain-relieving     medication). SABER™-Bupivacaine is designed to continuously deliver bupivacaine, a common     local anesthetic, for a few days in order to treat local post-surgical pain.      The purpose of this study is to investigate safety (side effects) associated with the use of     SABER™-Bupivacaine and how well it works in reducing pain and opioid-related side effects     following various kinds of abdominal surgeries.   "
243886|NCT01052025|"     The incidence rate of type 2 diabetes in Thai populations is high and increasing every year.     Cardiovascular disease is the main complication of this disease, which has been defined as an     important cause of death among Diabetic patients. This disease is now becoming a major health     problem and causes a great economic loss to the country. Evidence shows that Curcumin, Thai     herbal medicine, has the effectiveness of prevention and delay of type 2 diabetes. However,     there is no scientific study that aims to prove the efficacy of this herb particularly for     prevention and delay the disease in Patients with impaired glucose tolerance (pre-diabetes)     and insulin resistance.   "
243887|NCT01052038|"     Sore throat is a common postoperative complaint that can lead to morbidity and patient     dissatisfaction . The incidence of sore throat has been reported to be between 6% and 90%     even under optimal intubating conditions. There are several factors that have been shown to     contribute to postoperative sore throat such as patient related factors, type of anesthesia     and type of surgery.      Corticosteroids are also commonly used in the perioperative period to potentiate analgesics     and as antiemetics. The preoperative administration of dexamethasone can decrease the     incidence and severity of postoperative sore throat which is rated by patients as one of the     most undesirable outcomes in the postoperative period.   "
243888|NCT01052051|"     To determine the effect of increasing serum 25(OH)D from prevailing levels with vitamin D3     supplementation, while maintaining adequate calcium intake, on incidence of all-type cancer     in a population sample of healthy postmenopausal women.   "
243889|NCT01052064|"     Low frequency repetitive Transcranial Magnetic Stimulation(rTMS) is a safe and tolerable     procedure in children with Attention Deficit Hyperactivity Disorder(ADHD); it also could be a     complement to the treatment of patients with poor symptomatic control to conventional     treatment.   "
243890|NCT01052077|"     This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will     receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive     substance) in addition to an FDA approved antidepressant in order to determine if the study     medication is effective as an add on treatment of MDD.   "
243891|NCT01052090|"     To evaluate the safety, tolerability and efficacy of escalating dose of PHN121 when     administered orally in non-responder hepatitis C genotype 1 patients   "
243893|NCT01052116|"     The trial is designed to study the effects of soy supplements on asthma control.   "
243897|NCT01052168|"     Emphasizing the growing popularity of motion metrics are the majority of available virtual     reality simulators and some newer hybrid models that offer motion tracking for performance     assessment. A popular hybrid model (PROMIS) allows training with regular laparoscopic     instruments in a box-trainer while automatically recording task duration and movement     efficiency (pathlength and smoothness) that are immediately offered as feedback to trainees.      Despite the increasing availability of simulators that track motion, our knowledge of the     impact those metrics have on trainee learning is severely limited. We do not know if it is     more important to use speed, accuracy, motion efficiency or a combination thereof for     performance assessment and how these metrics impact skill transfer to the OR.      Based on sound educational principles we have developed a proficiency-based laparoscopic     suturing simulator curriculum. This curriculum focuses on deliberate and distributed     practice, provides trainees with augmented feedback and sets expert-derived performance goals     based on time and errors. We have previously demonstrated that this curriculum leads to     improved operative performance of trainees compared to controls.      To measure operative performance and determine transferability, we will use a live porcine     Nissen fundoplication model. Instead of placing actual patients at risk, the porcine model is     preferable for this purpose as it offers objective metrics (targets are established,     distances measured, knots are disrupted for slippage scoring), complete standardization, and     allows multiple individuals to be tested on the same day.      We hypothesize that proficiency-based simulator training in laparoscopic suturing to     expert-derived levels of speed and motion will result in better operative performance     compared to participants training to levels of speed or motion alone. The study is powered to     detect an at least 10% performance difference between the groups.      Specific Aims        1. Compare whether any performance differences between the groups persist long-term        2. Assess whether the groups demonstrate differences in safety in the operating room by          comparing the inadvertent injuries in the animal OR between the groups        3. Identify the training duration required by novices to reach proficiency in laparoscopic          suturing based on speed, motion efficiency, or a combination of these metrics        4. Identify any baseline participant characteristics that may predict individual          metric-specific performance   "
243898|NCT01052181|"     Type 2 diabetes is a major public health problem in India with an estimated a prevalence of     approximately 4% and 12% in rural and urban areas respectively. Accumulating evidence     suggests that serum cholecalciferol levels may be inversely related to the prevalence of     diabetes, insulin resistance and metabolic syndrome. The trials available on the effect of     Vitamin D supplementation on insulin/glucose metabolism have been conducted using small     sample sizes in different subgroups document variable results (significant decrease in HbA1c     concentration with insulin concentration in hemodialysis patients; insulin levels lower with     oral Vitamin D in gestational diabetes; no effect of Vitamin D on serum insulin levels in     post menopausal women). A double blind randomized controlled trial conducted at our institute     using 3,60,000 IU of cholecalciferol over 6 weeks documented improvement in OGIS index of     insulin sensitivity. We therefore, plan to study the long term effect of vitamin D     supplementation on peripheral insulin sensitivity.   "
243899|NCT01052194|"     This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3     inhibitor, for treatment of subjects with active RA. This study will assess the clinical     response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients     with active RA. The study will also evaluate the safety and tolerability of VX-509 compared     to placebo when administered for 12 weeks to subjects with active RA.   "
243900|NCT01052207|"     Role fo oxidative stress in adrenal insufficiency has not been studied. The degree of     oxidative stress and it's role in pediatric critical illness is unknown. Potential for     significant alterations to many of thew body's regulatory pathways may result from severe     oxidative stress. Further is needed to delineate what if any role oxidative stress may play   "
243901|NCT01052220|"     The major purpose of this quantitative study is to determine if a 3 month supportive     educative nursing intervention incorporating Blood Pressure (BP) education and BP, salt and     fluid monitoring, in addition to goal setting and reinforcement will improve BP control in a     chronic end-stage renal disease population.   "
243902|NCT01052233|"     It has been previously demonstrated that the risk for the development of knee osteoarthritis     is increased after both meniscus tear and meniscectomy. However, it is still unclear whether     this is due to the meniscus tear per se, the surgery, or whether the development of knee     osteoarthritis is completely independent of the two. Accordingly, the aim of the study is to     investigate the effect of arthroscopic partial meniscectomy on the development of knee     osteoarthritis 2 to 10 years after the procedure.   "
243915|NCT01052402|"     The purpose of this study is to assess the safety and immunogenicity (i.e. primary immune     response, immunogenicity of two different doses, antibody persistence 360 days after the     first vaccination, immune response to a heterologous booster given on Day 360) of a Vero     cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents     aged 6 months to 17 years.   "
243926|NCT01042210|"     The study is focused on the investigation of possible associations between plasma/serum     levels of agouti related peptide (AgRP) and its genetic background in healthy women with     physiological pregnancy (non-preeclamptic) and women with preeclampsia, in the postpartum     period, and in their offspring.   "
245518|NCT01063179|"     The proposed study will evaluate whether the combination of VELCADE, Thalidomide , Melphalan     and Prednisone (V-MPT), as induction treatment for newly diagnosed elderly MM patients,     improves outcomes compared to the combination VELCADE-MP.   "
243903|NCT01052246|"     The results of pulsed dye laser (PDL) treatment of acne vulgaris published so far are     controversial: Whereas Seaton et al. described a marked improvement of mild-to-moderate acne     after low-fluence pulsed-dye laser therapy, Orringer et al. were unable to replicate said     results in a similar, albeit not identical, study design. More recently published studies     failed to resolve the controversy, varying in terms of treatment procedure(s) as well as     results.      While published results are certainly promising enough to be followed up by independent     research, they are insufficient to justify the abdication of methods with proven efficacy.     Considering patient treatment ethics and the short 'window of opportunity' for scar     prevention when active inflammatory lesions are present, the investigators planned the     adjuvant application of the PDL in the present study, providing all patients with the well     established and evidentially effective modality of a fixed-combination clindamycin 1%-benzoyl     peroxide 5% hydrating gel (C/BPO). The goal of the study was the assessment of the efficacy     and safety of a low-fluence PDL treatment in addition to C/BPO in patients with facial     inflammatory acne.   "
243904|NCT01052259|"     The purpose of this study to examine the efficacy and safety of cycling treatment of     deoxyspergualin in renal transplant patients with biopsy-proven chronic rejection.   "
243905|NCT01052272|"     The investigators hypothesize that in patients with diabetes and acute myocardial infarction     (MI), Ang II type-1 receptor blockade (AT1RB) attenuates left ventricle (LV) remodeling to a     greater extent than angiotensin converting enzyme (ACE) inhibitor therapy and that the     addition of xanthine oxidase (XO) inhibitor, Allopurinol, results in further improvement in     LV remodeling and function in the follow-up phase after MI.   "
243908|NCT01052311|"     Laropiprant (LRP; Merck & Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily,     highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of     extended-release niacin and 20 mg of laropiprant (ERN/LRPT) offers improved tolerability,     supporting a simplified 1-2 g dosing paradigm and improved adherence. Statins and niacin     improve endothelial function in cardiac patients, however, there is no data yet regarding the     additive effects of raising HDL-C by ERN/LRPT and statins on endothelial function in cardiac     patients. Thus the aim of the present study is to evaluate the impact of 3 months'     administration of ERN/LRPT compared to placebo added to statins on endothelial function,     assessed by brachial artery vasoreactivity in stable cardiac patients.   "
243909|NCT01052324|"     Remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive     function. It can be used for conscious sedation during awake nasotracheal fiberoptic     intubation. Target-controlled infusion is more reliable technique for maintaining optimal     infusion rate than manual controlled infusion. The aim of this study is to determine the     effect site concentration of remifentanil for successful conscious sedation during awake     nasotracheal fiberoptic intubation.   "
243910|NCT01052337|"     Aim of this trial is to compare propofol-based anaesthesia vs. sevoflurane-based anaesthesia     induction in patients with cervical myelopathy receiving oral or nasal fiberoptic intubation.   "
243911|NCT01052350|"     The purpose of this study is to use a brain imaging method called PIB PET to determine     dementia subtypes in patients with Parkinson's disease. The ultimate goal of this project is     to be able to identify individuals with PD who are at risk of developing dementia, and to     distinguish the underlying cause of dementia.   "
243912|NCT01052363|"     Pilot Trial of CA4P with Avastin in Recurrent Gliomas   "
243913|NCT01052376|"     The principle objective of this study is to validate confocal endomicroscopy (CEM) in a     national, multicenter study, in terms of its ability to diagnose neoplastic lesions in vivo,     in two groups of patients at high risk of colorectal cancer (CRC): patients with familial     adenomatous polyposis (FAP) after colectomy in whom the neoplastic lesions are probably     under-diagnosed, and patients with inflammatory bowel diseases (IBD) in whom endoscopic     surveillance is particularly difficult. Methods: The study will be comprised of two phases     (Phase I and II). Phase I will serve to validate at the multicenter level the results of the     first, recently published, monocenter German study in terms of capacity of CEM to identify     the colonic neoplastic lesions in vivo. Phase II is destined to prospectively evaluate the     diagnostic yield of CEM in detection and prediction of neoplastic lesions by developing and     adding new features to the confocal pattern of in vivo diagnosis. Two cohorts of patients     will be studied in parallel: Patients with inflammatory bowel diseases (IBD), like ulcerative     colitis (UC) or Crohn's disease (CD), including those before planned colectomy, and patients     with FAP after colectomy. During lower endoscopy performed under general anaesthesia, each     colonic segment will be examined before and after staining with indigo-carmin. After     intra-venous fluorescein injection, all macroscopically abnormal lesions will be examined by     CEM, then biopsied. In parallel, multiple random biopsies will be performed, each coupled     with simultaneous CEM optical biopsy at the same point. In addition, during Phase II, in     IBD patients before planned colectomy and in patients with FAP, a mapping of colonic     mucosa, by obtaining a very high number of CEM optical biopsies, will be performed, and     will be correlated with standard histology performed either on colectomy specimens (IBD) or     on standard biopsies (FAP). Principal analysis (Phase I and II) will include evaluation of     inter-observer variation in terms of interpretation of in vivo histology and diagnostic yield     of CEM with respect to the detection of neoplastic lesions by evaluation of sensitivity and     specificity, using standard histology as reference method. Additional analysis (Phase II)     will be performed to evaluate the diagnostic and predictive (CRC risk) value of colonic     mapping by correlating optical images pattern score to results of standard histology.     Expected results: This study should guarantee high quality data, standardization of     procedures and of interpretation of CEM images, which are prerequisite for dissemination of     CEM in clinical practice. The investigators expect to show that CME allows to reliably     discriminate between neoplastic and non-neoplastic lesions, that, compared to standard     histology, provides better characterization of lesions, especially in the context of extended     lesions like in IBD, an finally, that CME images can be used to develop a new optical     biopsy-based score allowing prediction of high CRC risk in patients with FAP and IBD. The     investigators believe that CEM may increase, as compared to currently used techniques, the     diagnostic yield in terms of probability of the detection of neoplastic lesions in patients     at high risk of CCR, and may become a new standard for endoscopic surveillance in these     patients.   "
243914|NCT01052389|"     The GiSAS study is a multi-centre randomized clinical trial that will involve about 80     italian community psychiatric services in Italy and will recruit 800 patients affected by     schizophrenia.      In a sample of schizophrenic outpatients, it is hypothesized that there are significant     differences in the overall tolerability and effectiveness of aripiprazole, olanzapine and     haloperidol at 12 months.      It is a pragmatic trial. Thus, participants are selected to represent a broad range of     real-world patients, all treatment medications are non-blinded and after randomization, the     assigned drugs will be prescribed according to usual care practice.      The measure for effectiveness is retention of patients on the assigned treatment. The measure     for tolerability is the onset of metabolic syndrome.   "
248573|NCT01109069|"     The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen     of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small     lymphocytic leukemia (CLL/SLL).   "
243916|NCT01052415|"     In this project, UCLA's Center for Community Health (CCH) will develop an efficacious     intervention trial integrating both individual and structural components to reduce HIV-     related stigma among service providers in China and therefore benefit people living with     HIV/AIDS (PLWHA).      The purpose of this study is to develop a feasible, practical and low cost intervention     strategy that will prevent and/or reduce the negative effects of HIV-related stigma among     health service providers in China.      This project will be conducted in two provinces and proceed in two phases. In Phase 1,     confidential focus groups will take place with small samples of service providers and     hospital administrators to finalize the intervention activities, and the investigators will     also test and finalize the Audio Computer-Assisted Self-Interview (ACASI) assessment measures     and implementation procedures with the same group of service providers. During Phase 1 a     small sample of patients will anonymously test the paper-pencil baseline survey. Equal number     of samples will be selected from two counties of each province. The findings from Phase 1     will be used to develop intervention, and revise assessment for Phase 2.   "
243917|NCT01052428|"     The investigators hypothesize that beta-1 receptor blockade (ß1-RB) attenuates extracellular     matrix (ECM) degradation and progressive adverse Left Ventricular (LV) remodeling and failure     in the volume overload of mitral regurgitation (MR). Patients without coronary artery disease     and moderate MR, as assessed by color/flow Doppler echocardiography, will be randomized to     ß1-RB vs. placebo to address the following aims:      *Aim 1: Establish whether ß1-RB attenuates adverse LV remodeling compared to placebo in     patients with non-surgical, chronic MR. Using 3-dimensional magnetic resonance imaging (MRI)     and tissue tagging, LV function and geometry will be assessed at baseline and every 6 months     for up to 2 years.      Aim 2: Determine whether indices of inflammation correlate with degree of LV remodeling and     whether ß1-RB decrease indices of inflammation and collagen turnover. At the time of MRI,     blood samples for collagen breakdown products, matrix metalloproteinase (MMP) activity, and     markers of excess production of reactive inflammatory species (RIS) will be obtained and     related to changes in LV remodeling defined by serial 3-dimensional MRI and tissue tagging.   "
243919|NCT01052454|"     This is a study to determine if participation in a mindfulness-based stress reduction program     is feasible for women experiencing five or more hot flashes/day, and whether it affects     either the frequency and/or intensity of their hot flashes, or the degree of bother they     experience from them   "
243920|NCT01052467|"     This non-interventional, prospective, non-controlled study of Xamiol® Gel, a fixed     combination of calcipotriol and betamethason dipropionate, shall investigate in daily routine     the efficacy, tolerability and changes in quality-of-life parameters in patients with scalp     psoriasis   "
243921|NCT01042145|"     This randomized clinical trial was to compare the effectiveness of prednisone 2mg/kg/day for     3 days vs. dexamethasone 0.6mg/kg for 1 day for treatment of children with mild or moderate     croup. It was conducted in a practice-based research network of community pediatricians in     the St. Louis area. Outcomes included additional health care for croup, duration of symptoms,     nights of disturbed sleep, parental stress, missed work days, and adverse events. Our     hypothesis was that community-based treatment of children with mild or moderate croup with     multiple doses of prednisone is superior to a single dose of dexamethasone.   "
243922|NCT01042158|"     This will be a 36-week, randomized, double-blind, parallel group study comparing the effects     of tadalafil monotherapy, ambrisentan monotherapy and combination therapy with tadalafil and     ambrisentan in patients with PAH-SSc. Standard outcome measures such as six-minute walk     distance (6MWD), NYHA classification, and hemodynamic measurements will be assessed, as well     as novel functional measures of RV-PV function including the transthoracic echocardiogram     parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI     and heart rate variability assessed by Holter monitoring. This design (excluding a     placebo-placebo arm) was selected for ethical concerns and to provide optimal efficiency and     active therapy to all study subjects. It also allows for comparisons between the two     monotherapies and with combination therapy.   "
243923|NCT01042171|"     Confocal laser endomicroscopy (CLE) is a newly developed endoscopic technique. The most     commonly used fluorescent substance is Fluorescein sodium.The plasma half-life of ﬂuorescein     is 11 minutes. A recent test estimated that ﬂuorescein-based CLSM(confocal laser scanning     microscopy) of the upper-GI tract of pigs delivers the best contrast and image quality within     the ﬁrst 8 minutes after injection of ﬂuorescein .However, despite its increasing use in     clinical examination,there are no data on contrast dynamics and image quality over time after     injection of the ﬂuorescein sodium in the inspection of gastrointestinal tract of human     being.   "
243924|NCT01042184|"     Background: Helicobacter pylori infection has been shown to be associated with the     development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection     could reduce the occurence or recurrence of these diseases. However, the eradication rate of     clarithromycin-based triple therapy has been declining in recent years, probably related to     the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients     would fail from first line standard eradication therapy and need second line rescue therapy.     About 15-30% of patient would fail from second line therapy and need to be rescued with third     line therapy. In recent years, the concept of sequential therapy has been advocated in the     treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five days,     followed by a PPI plus clarithromycin and tinidazole for another five days. The eradication     rate in the first line treatment of sequential therapy had been reported to be as high as     90%. More importantly, it has been demonstrated that the eradication rate among patients with     clarithromycin-resistant strains could be as high as 89%. However, tinidazole is not     available in many countries. Whether metronidazole would be an effective alternative to     tinidazole in the sequential therapy remains unknown. Besides, whether extending the duration     of sequential therapy from 10-day to 14-day would result in higher eradication rate also     deserves further investigation. Furthermore, data on the efficacy of rescue regimens for     patients who failed from first line sequential therapy are also lacking. The impact of     clarithromycin, metronidazole resistance and CYP2C19 polymorphism on the sequential therapy     containing metronidazole (rather than tinidazole) also has not been reported.      Aims: Therefore, we aim to assess        1. whether the substitution of metronidazole for tinidazole in the sequential therapy is          also more effective than clarithromycin-based triple therapy        2. whether extending the duration of sequential therapy from 10-day to 14-day would achieve          higher eradication rate        3. whether levofloxacin-based sequential therapy for 14-days is effective as second line          rescue regimen for those who failed from first line sequential therapy        4. the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of          sequential therapy   "
243925|NCT01042197|"     The purpose of this study is to investigate the relation between vitamin D production after     UVB and exposed body surface areas with different UVB doses.   "
243927|NCT01042223|"     Laryngomalacia is the most common congenital laryngeal anomaly and the most frequent cause of     stridor in infants and children. Symptoms usually appear within the first 2 weeks of life.     Its severity increases up to 6 months. 15-60% of infants with laryngomalacia have synchronous     airway anomalies.   "
243928|NCT01042236|"     The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the     treatment of the condition of stress urinary incontinence   "
243929|NCT01042249|"     The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on     Lower Urinary Tract Symptoms (LUTS) in men after stroke.      120 men with LUTS or increased LUTS after stroke is included and randomized into a treatment     group or a control group. The subjects in the treatment group follows a 12 week standard PFMT     program, while the control group is not given specific treatment of their LUTS but like the     treatment group follows the standard rehabilitation program for stroke patient. Outcome are     measured by        -  5 questionnaires        -  Voiding diary        -  24-hour pad test        -  pelvic floor muscle assessment test   "
243930|NCT01042262|"     When exposed to oxygen immediately after birth, newborns suffer from an oxidative stress with     a significant decrease in serum concentration of the anti-oxidant enzyme superoxide     dismutase. This oxidative stress has been consequently linked to the development of adverse     outcomes in both premature and full term infants. In this study, we examined the effect of     oxygen administration to delivering mothers immediately before and during labor on the     newborn. In this randomized trial, we planned to measure superoxide dismutase in the     umbilical cord blood when mothers received and did not receive oxygen..   "
243931|NCT01042275|"     Midurethral tapes are by now standard procedure in the surgical treatment of women with     stress urinary incontinence. While the retropubic TVT is well documented with long-term     results up to 11 years and continence rates of 90 %, the published data for the transoburator     tapes (TO) cover follow-up of 3 years only. So far, all tapes establish continence     effectively. Recently, the detailed 27-item Incontinence Outcome Questionnaire (IOQ) was     constructed to assess patient-reported outcome and quality of life after insertion of a     midurethral tape and validated for the German language. The aim of this study was to evaluate     patient-reported mid- and long-term outcome after insertion of tension-free vaginal tape     (TVT), transobturator sling, outside-in (TOT) and tension-free transobturator tape,     inside-out (TVT-O).   "
244096|NCT01054079|"     This phase II trial is studying how well cinacalcet hydrochloride works in treating men with     recurrent prostate cancer. Cinacalcet hydrochloride may be effective in lowering     prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has     not responded to previous treatment   "
243932|NCT01042288|"     The purpose of this multicenter, Phase II trial is to examine the role of a well-tolerated     novel agent, panitumumab, in combination with a modern platinum doublet regimen using     carboplatin and pemetrexed, in patients with advanced non-squamous wild type K-ras     non-small-cell lung cancer (NSCLC). If this treatment proves to be well tolerated and     associated with efficacy, this would provide rationale for further randomized studies.   "
243933|NCT01042301|"     The Lymphoscreen study aims to characterize precisely (phenotypes/cytokines/functions) CD8+     T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are     needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic     approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization     of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2     beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by     autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in     humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1     Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and     autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or     humoral markers of the disease (such as serum miRNA).   "
243934|NCT01042314|"     The purpose of this study is to find out if the plasma concentration of donepezil is changed     when BMS-708163 is administered at the same time   "
243935|NCT01042327|"     Today, haemodialysis is a recognized standard treatment for patients with chronic kidney     disease stage 5. During the haemodialysis treatment session, blood passes from the patient     through the extracorporeal circuit and is then returned. The dialyzer represents the greatest     surface are of the extracorporeal circuit, as dialysis treatment is essentially based on the     removal of small molecular weight solutes down along a concentration gradient, and this     depends upon surface area. The ELISIO-H dialyzer differs in design to our current standard     dialyzer, the FX100, by having fibers of a greater internal diameter, which potentially     allows more internal haemofiltration, leading to an improved clearance of larger molecular     weight solutes. It is now thought that these so called middle molecular weight solutes are     more important in contributing to the clinical condition termed azotaemia, rather than     smaller solutes such as urea.      The investigators therefore wish to study the clearance of middle sized molecules between the     different dialyzers.   "
243936|NCT01042340|"     Background and aims:      Old patients seldom reach energy requirements. The effects of an oleic-acid rich formula on     energy intake and appetite were studied.      Methods: Recently admitted geriatric patients (n=71), likely to stay more than 1 week were     randomised to receive a fat emulsion (Calogen, intervention group (IG)) or to standard care     (control group (CG)). Thirty ml of the emulsion were given 3 times daily, i.e. 420 kcal, and     was distributed at the regular medication rounds. Food intake and self-rated appetite were     registered 2-3 days after admission and on day 8 or the day prior to discharge. Nutritional     risk screening (NRS) 2002 and serum lipids and fatty acid profiles were analysed.   "
243950|NCT01042522|"     This randomized phase II trial studies paclitaxel and carboplatin to see how well they work     compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with     sex cord-ovarian stromal tumors that have spread to other places in the body and usually     cannot be cured or controlled with treatment (advanced) or has returned (recurrent). Drugs     used in chemotherapy work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving     more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known     which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.   "
243951|NCT01042535|"     This randomized phase I/II trial studies the side effects and best dose of vaccine therapy     and to see how well it works when given together with 1-methyl-D-tryptophan (1-MT) in     treating patients with metastatic breast cancer. Vaccines made from a person's tumor cells     and white blood cells may help the body build an effective immune response to kill tumor     cells.   "
243937|NCT01042353|"     -  Background: Ventilator-acquired pneumonia (VAP) is the most prevalent nosocomial          infection in intensive care units (ICUs). Early microbiological diagnosis and initial          administration of appropriate antimicrobial therapy are associated with a better          outcome. Broad-spectrum antibiotics should therefore be administered initially. However,          inconsiderate antibiotic use can increase the prevalence of multi-resistant bacteria.        -  Purpose: A rapid antimicrobial susceptibility method is required to decrease the          unnecessary use of empirical broad-spectrum antibiotics. The aim of this study is to          compare the efficiency of a rapid antibiogram, provided by E-test strips directly          applied to bronchoalveolar lavage (BAL) samples and analysed at 24 h, to that obtained          with standard methods of culture which provide a later result.        -  Study design: This will be an open-label, prospective cohort study of consecutive          patients with VAP, conducted in a medical ICU. In addition to standard culture methods,          an E-test will be performed directly on BAL samples and analysed at 24 h. Each standard          BAL culture will be used as a control for the E-test method.        -  Primary outcome: The occurrence of major errors, defined as isolates determined to be          susceptible by the E-test but resistant by standard culture methods.        -  Secondary outcomes: The occurrence of minor errors (defined as isolates determined to be          resistant by the E-test and susceptible by the standard method), and a comparison of two          methods of seeding BAL samples on Mueller Hinton agar plates (swabbing method, flooding          method).        -  Eligibility criteria:             -  Inclusion criteria: all patients with suspected VAP (defined by a Clinical               Pulmonary Infection Score ≥5) undergoing BAL will be eligible.             -  Exclusion criteria: contraindications for BAL (PaO2/FIO2 <100, risk of               bronchoscopy-related haemorrhagic complications), secondary exclusion of patients               with negative cultures, defined by a threshold of bacteria <104 CFU/ml.        -  Interventions:      BAL samples will be cultured by standard methods and the minimal inhibitory concentration     (MIC) of bacteria to the usual antibiotics will be determined using standard procedures. At     the time of BAL collection, a rapid antibiogram will be performed by placing E-test     antibiotic strips (AB Biodisk) directly onto Mueller-Hinton agar plates seeded with the BAL     specimen (both by flooding and swabbing). E-test strips will be impregnated with cefoxitin,     piperacillin-tazobactam, cefepime, imipenem, ciprofloxacin and amikacin. At 24 h, the E-test     plates will be photographed and then examined separately by both a bacteriologist and a     medical ICU physician following a consensus method. The final E-test results will be compared     with the standard MIC cultures.   "
243938|NCT01042366|"     The purpose of this study is to determine what effect using an experimental tumor vaccine (a     substance or group of substances meant to cause the immune system to respond to a tumor) made     using patients' own tumor cells and blood cells will have on their melanoma.   "
243939|NCT01042379|"     The purpose of this study is to further advance the ability to practice personalized medicine     by learning which new drug agents are most effective with which types of breast cancer tumors     and by learning more about which early indicators of response (tumor analysis prior to     surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are     predictors of treatment success.   "
243940|NCT01042392|"     This prospective multicenter, double blind study will evaluate the efficacy and safety of     aliskiren versus ramipril in patients with moderate systolic essential hypertension.   "
243941|NCT01042405|"     The aim of the study is to develop a simple computer program, evaluating nutritional status     of HD patients. The programming will enable to perform a nutritional screening, based on     biochemical measures, taken as part of HD patients' routine care every month. The program     will identify patients at risk of malnutrition, define the degree of malnutrition, and     identify patients who at risk for increased morbidity and mortality.   "
243942|NCT01042418|"     Food structure influence metabolic response including appetite. Whole grain foods include a     wide range of products; cracked or cut kernels, rolled flakes or milled to flour and used in     foods such as breads, breakfast cereals and pasta.   "
243943|NCT01042431|"     This study is a one-day international cross-sectional nutritional audit in one ward. The     purpose of this study is to generate a risk and level of nutritional intervention profile for     an individual unit/ward based on case-mix, structures and social environment.   "
243944|NCT01042444|"     This is a multi center, prospective study designed to demonstrate the safety and performance     of the GARDEX Embolic Protection System when used as an adjunctive device during saphenous     vein graft (SVG) interventions.   "
243945|NCT01042457|"     To evaluate therapeutic response to MMF treatment in patients with International Society of     Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis. Mycophenolic     acid levels at 1-hour post dose will be monitored monthly up to 6 months.   "
243946|NCT01042470|"     Pelvic floor dysfunction in the form of pelvic organ prolapse or urinary and fecal     incontinence is a sequela for some women who experience injuries during birth. It affects     adult women of all ages. The life time risk for women by age of 80 years for undergoing     surgical correction is shown to be 11.1 % , and 29 % of them will undergo re-operation for     recurrences later on. Still, even today the biomechanics of the pelvic floor is not     understood enough. The aim of our study is to investigate the biomechanical properties of the     female pelvic floor, i.e. the vaginal wall, by means of clinical, sonomorphometric     (ultrasound), histological and elastomechanical examinations. In principle, the     elasto-mechanical properties of the vaginal wall will be examined by the new and innovative     so called aspiration device, developed at the Eidgenoessische Technische Hochschule (ETH)     Zurich, Switzerland. This tool generates a low-pressure of -25 mbar at the vaginal wall,     aspirating it under visual control by aid of an integrated video camera and therefore     allowing to measure the difference of its convexity under aspiration and at rest. In case of     prolapse surgery, this allows us to take a biopsy of the measured vaginal wall and analyze it     at the Institute of Anatomy at the University of Zurich-Irchel by means of histological (e.g.     connective tissue, extracellular matrix) and molecular biological examination. With an     increasing elderly population, more and more women will need surgery for pelvic organ     prolapse. While effective in restoring anatomy, sometimes by aid of meshes made out of     polypropylene, the functional outcomes and quality of life are not always restored     satisfactorily. This interdisciplinary project intends to add a contribution to this for our     patient still bothersome situation and to help to detect risk factors for developing pelvic     floor dysfunction.   "
243947|NCT01042483|"     The purpose of this study is to establish normograms of parameters measured by the LaborPro     system, and to test the prediction of these parameters on labor progress and mode of     delivery.   "
243948|NCT01042496|"     This study compared glutamate and other neurometabolites measured by proton magnetic     resonance spectroscopy (1H-MRS) in bipolar I and II patients currently depressed with     age-matched healthy controls. The study will also compare 1H-MRS of bipolar I and II patients     before and after taking a 12-week course of lamotrigine.      The goal of this study was to better understand the neurobiology of bipolar depression and     how lamotrigine may therapeutically impact brain function and mood response.      The hypothesis was that in comparison to non-remission participants, bipolar participants who     achieve remission (defined as a Montgomery Asberg Depression Rating Scale (MADRS) score <12     at week 12) associated with lamotrigine monotherapy will exhibit a greater decrease in     glutamate (Glu) and an increase in N-acetyl aspartate (NAA), reported as a cerebrospinal     fluid (CSF)-corrected absolute concentration percent change from baseline to endpoint in     anterior cingulate (AC) and dorsolateral prefrontal cortex (DLPFC).   "
243949|NCT01042509|"     The purpose of this study is to determine whether low-doses alemtuzumab and rituximab     combination are effective in the treatment of chronic graft-versus-host disease (GVHD) after     first-line therapy failure.   "
246344|NCT01087671|"     The purpose of this study is to investigate if changes in ocular signs and symptoms occur in     patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005%     (Xalatan) to preservative free Tafluprost eye drops.   "
243952|NCT01042548|"     The current study is a case control study involving comparisons of tissue interstitial fluid     from breast cancer and adjacent non-cancerous tissue as well as that from benign breast     lesion and its adjacent non-diseased tissue for a distinguishable breast cancer profile. The     purpose of this research is to collect fresh breast nodule/cancer and surrounding     non-cancerous tissue for proteomic studies of the interstitial fluid to identify a profile     distinguishing breast cancer which will also permit future research on stored interstitial     fluid, blood or tissue samples. Specific markers identified from interstitial fluid study     will be investigated in blood samples to develop serum markers for breast cancer diagnosis     and prognosis. Additionally, we will perform both prospective and retrospective research on     breast cancer involving clinical, demographic, epidemiologic information, treatment,     follow-up and outcomes on breast nodule/cancer cases collected.   "
243953|NCT01042561|"     We hypothisize that serum 25(OH)D levels in infants 32 weeks and greater gestation are not     maintained at optimal levels of greater than 32 ng/Ml with currently available infant     formulas, and that this will have an inverse relationship with markers of inflammation and     bone metabolism.   "
243954|NCT01042574|"     This study is a single-arm, open label protocol evaluating the use of Cleviprex to rapidly     control hypertension in patients who present with intracerebral hemorrhage (ICH) or     subarachnoid hemorrhage (SAH), and that require ICP monitoring via ventriculostomy (External     Ventricular Drain or EVD).   "
243955|NCT01042587|"     The investigators hypothesize that significant exposure to artificial morning bright light     (approximately 200 lux of primarily blue light at eye level for thirty minutes daily) as     compared to sham bright red light (placebo) will:        1. improve sleep quality        2. improve cognitive scores        3. improve depression scores        4. improve quality of life scores.   "
243968|NCT01042769|"     This double-blind, parallel, two-arm study will evaluate the potential to reduce     cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to     placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and     type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or     placebo once daily as oral doses. The study will last until at least 950 events occur, but     time on study treatment will be for at least 2.5 years.   "
243956|NCT01042600|"     In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via     nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of     surfactant via and endotracheal tube airway(inserted after pre-medication for pain), or to     surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and     return babies to nasal CPAP, after surfactant is given. The primary outcome measure is the     rate of failure of initial surfactant therapy. Standardized failure criteria are reached: a)     early, if the baby is unable to be placed back on CPAP (needs mechanical ventilation) or, b)     late, if the baby requires retreatment with surfactant within 8 hours or more than 2 doses of     surfactant.      The objective of this protocol is to reduce the need for endotracheal intubation and     mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by     instilling surfactant though an LMA, while achieving comparable efficacy of surfactant     treatment.      The hypothesis is that surfactant treatment through an LMA will decrease the proportion of     babies with RDS who require mechanical ventilation or subsequent intubation, when compared     with standard surfactant treatment following sedation and endotracheal intubation.   "
243957|NCT01042613|"     1. This study will compare the first attempt success rate of cannulation in research          participants randomized to using a new FDA approved AccuVein AV300 device for          intravenous access with research participants randomized to standard cannulation          methods.        2. This study will assess if insertion of intravenous cannula is faster when intravenous          access is assisted by the AccuVein AV300 device as compared to the standard technique.        3. This study will assess if the number of skin punctures is fewer when intravenous access          is assisted by the AccuVein AV300 device as compared to the standard technique.   "
243958|NCT01042626|"     The purpose of this study is to assess if subjects with hyperparathyroidism with normal serum     calcium levels have different responses in the calcium regulating hormonal handling compared     to a) patients with primary hyperparathyroidism and high serum calcium levels; b) healthy     subjects.      The differences will be evaluated with oral peptones load and subsequent blood samples     collected every 15 minutes for two hours. Ionized calcium, phosphate, gastrin and PTH levels     will be evaluated.   "
243959|NCT01042639|"     Studies have demonstrated that brief (5-10 min a day) passive range-of-motion exercise is     beneficial for bone development in very low birth weight (VLBW) preterm infants. However, the     optimal duration and frequency of exercise for bone development in preterm infants is yet     unknown.      The effect of exercise on the immune system was widely studied in adult and children.     Exercise induces increase in IL-6, IL-10, and IL1ra. In adult even 10 minutes of flexion and     extension of the wrist cause systemic increase in IL-6. The effect of physical activity on     pro and anti inflammatory cytokines in preterm infant was not studied.      Objectives:        1. To assess weather twice daily exercise intervention will enhance bone strength compared          to once a day intervention        2. To evaluate the effect of a single exercise intervention on inflammatory mediators.      Methods:      Single center (Meir Medical Center), double blind, randomized control study.   "
243960|NCT01042652|"     This is a pilot randomized controlled Open-label trial to compare raltegravir and nevirapine     as anchor Drug in combined antiretroviral therapy(ART) for ART-naive HIV+ Chinese injection     drug users who are also on methadone maintenance therapy. The investigators hypotheses     include:        1. In raltegravir arm compared with nevirapine arm, fewer patients will require methadone          dose adjustment to abate methadone withdrawal symptoms. Also the average methadone dose          to achieve adequate serum methadone concentrations in patients on the raltegravir-based          regimen will be lower compared to that of patients on the nevirapine-based regimen.        2. Clinical outcomes in terms of viral suppression, CD4 recovery and occurrence of          opportunistic infections will be comparable in the two arms at 6 months and one year.        3. Patients in the raltegravir arm will have a similar or better side effect profile,          retention rate, and treatment adherence compared to those in the nevirapine arm.   "
243961|NCT01042665|"     The purpose of this investigation is to evaluate the relationship between IOP fluctuation,     RGC dysfunction, and optic nerve and retinal nerve fiber layer (RNFL) thickness changes in     patients with glaucoma and ocular hypertension receiving latanoprost 0.005% versus placebo.   "
243962|NCT01042678|"     The purpose of this study is to assess the safety and tolerability of MP0112 (a novel,     potentially long acting VEGF inhibitor) in patients with diabetic retinal edema.   "
248252|NCT01104974|"     This is a survey study to assess the variability in the current management of pregnancy,     reproductive care and assisted reproductive technologies for HIV-positive individuals in     Canada to estimate interest for further projects.   "
243963|NCT01042691|"     The primary goal of this research study is to determine a safe dose for the drug oxaliplatin     when delivered by isolated hepatic perfusion. The second goal of this research study is to     determine if isolated hepatic perfusion with oxaliplatin can improve the efficacy of standard     hepatic arterial infusional (HAI) therapy with floxuridine (FUDR)/leucovorin.   "
243964|NCT01042704|"     The purpose of this study is to see if the combination of bendamustine, lenalidomide and     dexamethasone will help people with multiple myeloma that has returned after standard     treatment or has been resistant to other treatments.   "
243965|NCT01042717|"     The purpose of this study is to determine whether it is safe and effective to collect     peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after     administration of plerixafor.   "
243966|NCT01042730|"     The purpose of this study is to evaluate the prevention of cardiovascular disease by moderate     cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering     therapy, pitavastatin 4mg/day in patients with stable coronary artery disease.   "
243967|NCT01042743|"     The recent introduction of robotic surgical system has revolutionized the field of minimally     invasive surgery. The investigators hypothesized that adoption of a robotic surgical system     for patients with right-side colon cancer seems appealing because This system provides     high-definition three-dimensional vision, eliminates physiologic tremor, and better     ergonomics. This randomized controlled trial was designed to determine the safety and     efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.   "
243969|NCT01042782|"     Patients with advanced gastric cancer are treated with a combination of RAD001 (everolimus)     and Mitomycin C.   "
243970|NCT01042795|"     The purpose of this study is to determine whether sutent (sunitinib)is effective in     preventing tumor recurrence in patients with high risk bladder cancer who have previously had     chemotherapy and cystectomy (bladder removal).      A 4 month supply of the drug is given to patients beginning 2-3 months after bladder removal.     The patients are followed up to 2 years.   "
243971|NCT01042808|"     This survey is conducted for preparing application materials for re-examination under the     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the     clinical usefulness of Isentress through collecting the safety and efficacy information in     usual practice according to the Re-examination Regulation for New Drugs.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
243972|NCT01042821|"     This study comprises a prospective study of 40 patients with transphincteric anal fistula.     The patients were classified into two groups: Group I: Fistulectomy, closure of internal     sphincter and rectal advancement flap includes mucosa, submucosa, and circular muscle layer     sutured 1cm below the level of internal opening. Group II: The same as group one but the flap     includes only mucosa and submucosa.   "
243973|NCT01042834|"     Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea     in older subjects.   "
243974|NCT01042847|"     There is growing evidence that our immune system can help fight cancer. This has stimulated     interest in the development and application of tumor vaccines for several human solid tumors,     including epithelial ovarian cancer (EOC). A major obstacle to the development of these     vaccines is that there are specialty cells called regulatory T cells that prevent the immune     system from attacking all of our organs. These regulatory T cells also prevent our immune     system for attacking cancer cells.      Indoleamine 2,3-dioxygenase (IDO), an enzyme that degrades an essential amino acid tryptophan     that is necessary for T cells to multiply, however regulatory T cells are less susceptible to     low levels of tryptophan, and can still multiply. This allows cancer growth and progression.     This may be explained by genetic polymorphisms (changes) in the IDO gene, which may alter its     function. Five of these changes in the IDO gene have been described. In this research     project, we are asking if you would donate a small piece of your tumor and ascites to see if     we can examine your IDO gene in the tumor cells and see if any of these gene changes are     present. We hope that this will help us understand how the immune system works in EOC.      We hypothesize that genetic polymorphisms within the IDO gene alter its enzymatic activity     and affect the outcome of ovarian cancer patients. These findings have the potential to     translate into a method for predicting successful immunotherapy.   "
243975|NCT01042860|"     Rationale: Age-related macular degeneration is the most common cause of blindness in the     industrialized world. Macular pigment is hypothesized to protect against the vision loss in     this disease.      Objective: 1. To study if the macular pigment optical density can be raised by lutein     supplementation. 2. To study if lutein supplementation can stop or slow down the decrease in     visual functions.      Study design: Randomized, double blind, placebo controlled intervention study.      Study population: Eighty patients with early signs of age-related macular degeneration     Intervention: The intervention group (40 subjects) receives 10 mg lutein per day, while the     control group (40 subjects) gets a placebo.   "
243976|NCT01042873|"     A decrease in the response of beta 1 adrenergic receptors to agonists (desensitization) is     thought to play a major role in the pathogenesis of diseases such as congestive heart     failure. However, currently, there is no in vivo model that will enable us to measure     desensitization of the hemodynamic responses to beta 1 adrenergic receptors in vivo.      Our hypothesis is that constant 3 hours intravenous infusion of the selective beta1     adrenergic receptor agonist dobutamine will result in gradual decline in hemodynamic     responses to dobutamine over time.   "
243986|NCT01043003|"     RATIONALE: Studying quality-of-life in patients having cancer treatment may identify the     intermediate- and long-term effects of treatment on patients with cancer      PURPOSE: This randomized clinical trial is studying how well an educational intervention     works in supporting Hispanic women with stage I, stage II, or stage III breast cancer and     their families or caregivers.   "
243977|NCT01042886|"     The PILI 'Ohana CBPR partnership implemented a pilot study to determine whether a Family plus     Community focused intervention will improve weight loss maintenance compared to Standard     follow-up in overweight/obese Native Hawaiian (NH) and other Pacific People (PP) adults (> 18     yr. old) after receiving a standard individual-focused behavioral intervention. The primary     hypothesis was that overweight/obese NH and PP adults that undergo a combined family-focused     plus community-focused intervention vs. a standard follow-up after receiving a standard     individual-focused behavioral intervention will have significantly higher rates of weight     loss maintenance.   "
243978|NCT01042899|"     This study will evaluate the effectiveness of an Internet-based psychosocial treatment in     improving problem-solving, communication skills, stress management strategies, and coping     among teens who have had a traumatic brain injury and their families.   "
243979|NCT01042912|"     The purpose of this study is to determine if carotid artery stenosis can be detected using an     electronic stethoscope. This study will use a commercially available electronic stethoscope     to record carotid sounds in patients with suspected carotid artery stenosis. The presence of     absence of abnormal vessels will be confirmed by diagnostic ultrasound as part of normal     patient care at this institution.   "
243990|NCT01043055|"     This study aimed to validate the diagnostic ability of the CDT (cancer detection technology)     software to detect breast cancer among women population.   "
243991|NCT01043068|"     The purpose of this study was to prospectively evaluate the effect of cancer pain management     protocol on hospitalized cancer patients.   "
243992|NCT01043081|"     The purpose of this study is to determine the rates of sexually transmitted infections (STI)     among a group of African American women who have sex with women (AA WSW). The first study     hypothesis is that AA WSW are at risk for acquiring and transmitting STI, including the human     immunodeficiency virus (HIV). The second study hypothesis is that AA WSW participate in     multiple high-risk sexual activities that may facilitate transmission of STIs, including HIV.   "
243980|NCT01042925|"     Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in     combination with trastuzumab (Herceptin) and in combination with trastuzumab and paclitaxel.     After the MTD is established for each combination (Phase 2), subjects will be enrolled to     evaluate the preliminary efficacy and safety of these combinations in metastatic HER2     positive breast cancer. Both trastuzumab and paclitaxel are used in the treatment of     metastatic breast cancer (MBC), but patients can develop resistance.      The link between PI3K mutations and trastuzumab resistance has been seen in breast cancer     patients. This suggests that inhibitors of the PI3K/PTEN pathway may have the potential to     restore sensitivity to trastuzumab. Similarly, introduction of activated mutant forms of PI3K     has been shown to transform and confer paclitaxel resistance to immortalized breast     epithelial cells. XL147 is a potent and selective inhibitor of PI3K and inhibits     phosphorylation of multiple downstream components of PI3K/PTEN signaling. Therefore, XL147     may have utility in the treatment of trastuzumab resistant/refractory and HER2-positive MBC     when administered in combination with trastuzumab alone or with trastuzumab and paclitaxel.   "
243981|NCT01042938|"     Ionizing radiation is a toxic agent and widely accepted form of treatment for various types     of cancer. Despite advances in medical technology, radiation therapy still causes severe     early and late skin effects. Radiation-induced dermatitis occurs in approximately 80% of     patients. Important consequences of radiation-induced dermatitis include impairment of the     quality of a patient's life due to pain and premature interruption of radiation treatment,     which in turn, may be impair good local control of disease. The biological pathways     responsible for acute radiation-induced dermatitis remain unclear. Currently, there is no     standard treatment for the prevention of radiation-induced dermatitis with demonstrated     effectiveness. The aim of this randomized, double-blind, placebo-controlled pilot study is to     assess the effectiveness of curcumin for the prevention of acute radiation-induced dermatitis     during postoperative radiotherapy for breast cancer. We hypothesize that curcumin, a natural     phenolic compound found in both turmeric and curry powders, can prevent or alleviate     radiation-induced skin reactions in breast cancer patients receiving radiotherapy.   "
243982|NCT01042951|"     Background: Severe dehydrating cholera due to V. cholerae O1 is an important public health     problem in Bangladesh and many other developing countries. V. cholerae O1 is a major     bacterial pathogen causing around 5 million cases and at least 200,000 deaths in adults and     children each year. It can be assumed that there are at least 300,000 severe cases and 1.2     million infections in people in Bangladesh alone. The rate of cholera varies from around 1 to     8 per 1000 population and the highest attack rate is in children 2- to 9-year years of age .     Cholera is now also being documented in very young children. Currently enteric vaccine     approaches are regarded as the most accessible short term and practical means to prevent and     control such illnesses to prevent disease and epidemics in resource poor settings with     limited public health and sanitary facilities.      An effective inactivated whole cell bivalent cholera vaccine against Vibrio cholerae O1 and     O139 was produced and implemented for public health purposes in Vietnam since the 1990s. This     bivalent vaccine has been found to be safe and to confer significant protection against El     Tor cholera in both children and adults and has over the last decade being used in the     Vietnam to protect against cholera. This vaccine has further been reformulated by the IVI to     meet WHO requirements and is now being produced in WHO prequalified vaccine company in India.      The reformulated vaccine has been shown to be safe and immunogenic in Indian children as well     as adults. A large Phase III study of the vaccine, has recently been carried out in Kolkata,     India in over 120,000 participants aged from one year and above. Results of the study are     encouraging and the vaccine gives over 60% protection against cholera. The vibriocidal     antibody response rate was 80% in children and 53% in adults. Following this study, the     vaccine, designated as ShanChol has been licensed in India in April 2009. The vaccine is now     being marketed in India and is available at a cost affordable for developing country     settings.      Objective: The aim of the proposed study is to assess if the orally administered, killed,     bivalent whole-cell cholera vaccine, ShanChol will be safe and immunogenic in different age     groups in Bangladesh in children and adults.      Study design: This will be a randomized, double blind, placebo-controlled study on a total of     330 subjects, 165 vaccine and 165 placebo recipients. The specific aims will be to determine:     i) safety and determine adverse events if any (ii) determine immune responses.      Relevance: The study of ShanChol on Bangladeshi children and adults will be able to give     information regarding the safety and immunogenicity of the vaccine in Bangladeshi subjects.     This information will be important for proceeding with larger studies in Bangladesh and if     proven useful for introduction the cholera vaccine in the country in the future.   "
243983|NCT01042964|"     Primary objective:      To evaluate safety and tolerability, adverse events (AEs), vital signs, ECG, bleeding time,     evaluation of antibody titer and safety laboratory tests      Secondary objectives:      To evaluate the pharmacokinetics and pharmacodynamics (platelet aggregation)of six ascending     single intravenous doses of PR-15 in healthy volunteers   "
243984|NCT01042977|"     This study is carried out to assess whether dapagliflozin improves glycemic control,     decreases fasting plasma glucose levels, body weight and blood pressure when added to     patient's existing medications and how it compares with their usual treatment without added     dapagliflozin. Safety data will be collected and analysed to confirm that treatment with     dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular     disease   "
243985|NCT01042990|"     Testing Adaptive Physical Activity in Stroke tests the idea that adaptive physical activity     (APA) will improve fitness, balance and walking function, daily step activity, and outcomes     related to quality of life in individuals with chronic stroke. Adaptive physical activity is     an exercise model that combines aerobic exercise with balance and gait training in a socially     reinforcing group setting. Individualized homework assignments encourage integration of     exercise into daily life routines. Our specific aims are:        1. to determine whether APA improves cardiovascular fitness and metabolic health        2. to measure the effects of APA on gait and balance, ambulatory activity, and ADL function        3. to determine whether APA affects self-reported outcomes related to self-efficacy,          fatigue, and stroke-specific quality of life   "
243987|NCT01043016|"     The purpose of this study is to determine the safety and maximum tolerated dose of     Photocyanine injection in photodynamic therapy of malignant tumor (especially skin cancer and     esophageal cancer).      Projected accrual: A total of 18-24 patients will be accrued for this study.   "
243988|NCT01043029|"     This multi-center, randomized, double-blind, active controlled, parallel-group study in type     2 diabetes patients with moderate renal impairment will evaluate the effect on renal function     and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be     randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses.     In addition, a diet and exercise plan will also be implemented during the anticipated time on     study treatment of 52 weeks. The target sample size is 200-400 patients.   "
243989|NCT01043042|"     Both hypoglycemia and hyperglycemia can be detrimental to hospitalized patients. However, it     is not clear which patients are more likely to develop significant problems with hypoglycemia     or severe hyperglycemia in the hospital. Our hypothesis is that we will be able to identify     risk factors present at admission that identify patients at greater risk of poor inpatient     glycemic control   "
243993|NCT01043094|"     This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are     planned (8 subjects in Group A and 8 subjects in Group B):      The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the     ranges for comparison will be obtained from the pooled demographic data of the renally     impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A,     the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men     to women in Group B will be the same as in Group A.   "
243994|NCT01043107|"     Thyroid Cancer is one of the most common malignant carcinomas. The incidence of thyroid     cancer has risen in the past years. The recrudesce rate is highly raised. Computer is widely     used by people nowadays, is it a predisposing factor to the highly raised recrudesce rate?     This research observed two random assigned groups, in which the patients were diagnosed by     pathologic results. One group were strictly prohibit with using computer, the other were not     told. Finally collect the recrudesce rate of each group, analyze the data by statistic     software.   "
243995|NCT01043120|"     The main purpose of this clinical research trial was to evaluate the effects of barusiban     compared to placebo on uterine contractions on luteal phase uterine contractions in oocyte     donors supplemented with progesterone.   "
243996|NCT01043133|"     The purpose of the study is to measure the effectiveness of a social marketing-based medical     education intervention on student use of evidence-based templates for documenting outpatient     asthma care within an electronic medical record.   "
243997|NCT01043146|"     Primary Trial objectives:      To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160,     240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on     verum per dose level, 10 subjects receiving placebo)      Secondary objectives:      To evaluate safety and tolerability by using adverse events (AEs) and vital signs   "
243998|NCT01043172|"     The investigators propose to evaluate efficacy and safety of gemcitabine in the adjuvant     treatment of cholangiocarcinoma after potentially curative treatment with surgical resection.   "
243999|NCT01043185|"     The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on     the number of reflux episodes, in patients who have GERD and still experience symptoms     despite proton pump inhibitor (PPI) treatment.   "
244000|NCT01052480|"     This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and     pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B.     Hospitalized subjects with influenza A or B that have either a low oxygen level or a high     respiratory rate will be eligible for study participation. This study will enroll adults,     children and pregnant women.   "
244001|NCT01052493|"     When humans eat, the bowels naturally secrete chemicals into the bloodstream which make     people feel full and which stop eating. One of these chemicals is known as Pancreatic     Polypeptide (PP). We have previously shown that injections of human PP reduces appetite and     food intake. We have now developed a very similar chemical, PP 1420, as a treatment for     obesity. PP 1420 has been tested in animals and has been shown to be safe, and to reduce     their appetite. This study will test PP 1420 for its safety and tolerability in humans.   "
244002|NCT01052506|"     The primary objective of the study is to evaluate the safety and tolerability of single dose     of BIIB033 administered to healthy adult volunteers.   "
244003|NCT01052519|"     The purpose of the study is to compare non-obese patients (BMI≤ 30 kg/m2)versus obese     patients (BMI> 30 kg/m2) in regard of their respective needs for intraoperative fluid therapy     during laparoscopic surgery.      Specifically the investigators will test the hypothesis that subcutaneous tissue oxygenation     (PsqO2)is increased in obese patients when fluid management is optimized by means of     esophageal Doppler monitoring compared to obese patients undergoing standard fluid     management.      Furthermore the investigators will test the hypothesis that PsqO2 is decreased in obese     patients undergoing conventional fluid therapy compared to non-obese patients when fluid     management is optimized. Thus the investigators assume that PsqO2 is similar in obese and     non-obese patients when fluid management is optimized in both groups.   "
244004|NCT01052532|"     The investigators hypothesize that MR in humans is characterized by adrenergic overdrive,     reactive nitrogen species, and an antifibrotic phenotype that relate to the severity of     adverse LV remodeling prior to surgery and outcome after valve repair.   "
244005|NCT01052545|"     Overtreatment of asymptomatic bacteriuria (ABU) is a quality, safety, and cost issue,     particularly as unnecessary antibiotics lead to emergence of resistant pathogens. Our     proposal to bring clinical practice in line with published guidelines has significant     potential to reduce unnecessary antibiotic use for ABU in the VA healthcare system, thus     improving the quality and safety of veterans' healthcare. Our study will also provide     important insights about how to implement and sustain evidence-based clinical practice within     VA hospitals.   "
244006|NCT01052558|"     The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular     micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle     glaucoma or ocular hypertension and co-existing cataract.   "
244007|NCT01052571|"     To evaluate differences in outcomes in patients receiving steroids compared to those patients     randomized to the local anesthetic group who did not receive steroids.      To evaluate and compare the adverse event profile in all patients.   "
244008|NCT01052584|"     In this stdy, patients aged above 6 months with symptomatic malaria presenting to health     centers will be enrolled for treatment with artemether-lumefantrine for P. falciparum     infection, and either artemether-lumefantrine or chloroquine for P. vivax infection.     Clinical, parasitologic, and hematologic parameters will be monitored for P. falciparum and     P. vivax infection over a 42-day follow-up period, which will be used to evaluate drug     efficacy. Results from this research study will be used to assist Ethiopia in assessing their     current national malaria drug policies.   "
244038|NCT01053312|"     This study will determine the level of association between the quantitative estimates of     brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of     amyloid levels in biopsy samples previously obtained during shunt placement in patients who     have normal pressure hydrocephalus (NPH).   "
244097|NCT01054092|"     The primary objective of this study is to evaluate the long-term safety of ASP1941 in     patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and     pharmacokinetics of ASP1941 administered before or after food intake.   "
244009|NCT01052597|"     There are evidence that there is an association between insulin resistance and prolonged     hyperinsulinemia or hyperglycemia in Type 2 diabetic patients. This will trigger oxidative     stress system via reactive oxygen species (ROS) and lead to a high level of Nitric oxide.     This can contribute to a significant change in blood vessel and could end up with the     complications from cardiovascular disease and increased mortality rate of type 2 diabetic     patients. The purpose of the present study was to examine the effectiveness of the curcumin     in type 2 diabetic patients on the reduction of atherosclerosis events by examining     pulse-wave velocity (PWV) and plasma high-sensitivity C-reactive protein (CRP) test and on     blood sugar lowering, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance.   "
244010|NCT01052610|"     The purpose of the trial is to asses the efficacy and safety of sublingual annual     immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house     dust mites.   "
244011|NCT01052623|"     This study will evaluate the status of the growth hormone/ insulin-like growth factor-1     (GH/IGF-1) axis in relation to growth failure, body weight and composition and     neuroprotection in children with Ataxia telangiectasia (AT).   "
244012|NCT01052636|"     Specific Aims      The long-term objective of this study is to examine the effectiveness of an intervention     program for older patients with hip fracture. First, an intervention program for elderly     patients with hip fracture will be developed and implemented, then, the effectiveness of the     intervention program will be examined. The specific aims are as follows:        1. To develop a well conceived and feasible protocol of hospital discharge and sub-acute          care that involves the coordinated work of health care professionals (physicians,          surgeons, nurses, and physical therapists) and the informal caregivers. The feasibility          of implementing such a protocol within the context of an intervention study subject to          the constraints of the clinical setting (i.e., CGMH) will be evaluated in a pilot study.        2. To conduct a randomized clinical trial to evaluate the outcomes and costs associated          with the proposed hospital discharge/sub-acute care protocol for elderly patients with          hip fracture. Both experimental and case study methods will be used. Information on          outcome indicators including clinical outcomes, quality of life, self-care ability,          family caregiving outcomes, patient and caregiver satisfaction, and services utilization          will be collected and compared between the control group and the experimental group.        3. To conduct a validation clinical trial to verify the results of the primary randomized          clinical trial and increase the generalization of the study findings.        4. To estimate the cost of this care model and its variations for individual patients.   "
244013|NCT01052649|"     Study on healthy volunteers is focusing on analysis of transcriptome profile fluctuations in     healthy population in three mononuclear cell types (CD4+ cells, CD56+ cells and CD4+CD25+     cells)and should provide a reference for comparison with transcriptomic data of any disease     state.Furthermore, metabolome and immunological status are defined on same samples.   "
244014|NCT01052662|"     The purpose of this study is to examine the effect of memantine and buprenorphine on opioid     abusing behavior, to determine the effect of memantine and buprenorphine on early relapse and     to evaluate the tolerability of memantine co-administrated with buprenorphine. The study     seeks to determine if combined treatment of memantine and buprenorphine may provide     shorter-term treatment for opioid dependence.   "
244015|NCT01052675|"     In France, the Afssaps is the body in charge of the evaluation of pharmacodependance. In     order to fulfil its mission, the Afssaps has created a network of 11 Centres for Evaluation     and Information on Pharmacodependance (CEIP), coordinated by the Drugs and Psychotropics     Unit. Pharmacodependence notifications issued by professionals are collected by each Centre     which evaluates them. Nantes' CEIP created an original tool to harmonize case reporting and     make it possible to homogeneously evaluate the seriousness of pharmacodependence cases as     each CEIP had his own way of analysing his cases. The aim of this study is to assess this     tool.   "
244016|NCT01052688|"     To collect samples for the purpose of developing and optimizing an in vitro noninvasive     prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA     extracted from whole blood samples collected from women who are pregnant with a fetus     previously determined to have a chromosomal abnormality. The NIPD result will be compared to     the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR,     and/or any commercially available NIPD test.   "
244017|NCT01052701|"     This research is being done to find out whether abacavir (Ziagen®) lowers the levels of     ribavirin (Ribapak®) in the body of persons taking these two drugs.   "
244046|NCT01053429|"     This is a regulatory-required non-interventional pharmacovigilance study exploring the safety     profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient     population, thus, safety (and/or efficacy) signals will be checked at every visit during the     contracted study period until the maximum study end date, per the protocol, of April 2010.   "
244018|NCT01052714|"     This program aims to help Veterans who take antipsychotic medications lose weight. We use a     program based on the American Diabetes Association's Diabetes Prevention Program, and we     have modified it to fit the lifestyles of people with mental illness. All participants are     educated about nutrition and cutting down fat intake, how and when to exercise, and the     causes of diabetes and how to prevent it. Participants must be Veterans who live within one     hour of the Long Beach, West Los Angeles, Sepulveda, or West Los Angeles VA hospitals.   "
244019|NCT01052727|"     DOLCE Study: Day-care versus Overnight-stay Laparoscopic Cholecystectomy randomized,     controlled trial.      The aim of this study was to evaluate the feasibility, safety and patient acceptance of     outpatient LC in Italy. In particular this randomized clinical trial will use the SF-36 as     powerful instrument to compare quality of life and global health status after LC performed as     a day-care procedure or with an overnight stay.      Particular attention is taken to answer to the following methodological issues:        -  concealed randomization,        -  ITT analysis,        -  number of eligible, excluded and refusing patients clearly stated.   "
244074|NCT01053793|"     The purpose of this study is to determine the glycemic index of four varieties of potatoes     and to determine the bioavailability of polyphenols contained in these potatoes.   "
244184|NCT01055236|"     Hydroxyzine is one of antihistamines that antagonizes H1 receptor, and it's effects are     reducing pruritus, nausea/vomiting, and the mild effect of sedation.With these effects     Hydroxyzine should be used in the prevention of these symptoms.   "
244020|NCT01052740|"     Background:        -  X-ray mammography is the standard method for breast cancer screening. It is a          noninvasive test using x-rays to take pictures of breast tissue and detect any          abnormalities.        -  The National Institutes of Health (NIH) Clinical Center has a breast imaging unit that          has been accredited by the American College of Radiology. To maintain accreditation, the          unit must recruit a certain number of women to have clinical mammograms each year in          order to maintain a high level of clinical skills and experience for the radiologists          and technologists.      Objectives:      - To create a state-of-the-art mammography unit at the NIH Clinical Center in order to     maintain American College of Radiology accreditation of the NIH breast imaging facility.      Eligibility:      - Women who are eligible for breast cancer screening because of family cancer history,     genetic test results, or previous instances of cancer. Participants may not be pregnant or     nursing at the time of the screening.      Design:        -  Participants will provide a brief medical history on arrival at the NIH breast imaging          unit.        -  Each participant will have a standard mammogram performed by a radiology technician.        -  If the study is normal, participants will be told that no further evaluation will be          performed. If the results indicate a need for further imaging or tissue biopsy,          participants may elect to return to the care of their primary physician or to receive          further follow-up at the NIH Clinical Center.   "
244021|NCT01052753|"     The ultimate goal of this study is to find specific polymorphism of candidate genes     (particularly of dopaminergic and noradrenergic systems) associated with intermediate     phenotypes (e.g., executive functions, IQ, and other neuropsychological function) and/or     phenomenological phenotypes (subtypes, comorbidity, dimensional approach) of ADHD. We propose     to replicate the analysis of the candidate genes identified by previous genetic studies and     recent findings from GWAS on ADHD using the candidate gene association study design     (family-based case control study using parental controls and population-based case-control     study). These results may lead our research team: (1) to resolve controversies over     inconsistent findings in previous genetic studies and contribute to the literature on the     validity of ADHD and its subtypes using clinical and genetic data; (2) to identify potential     endophenotypes for ADHD genetic studies; and (3) to identify specific polymorphism of     candidate genes and gene expressions of dopaminergic and noradrenergic systems associated     with executive functions measured by the CANTAB.   "
244022|NCT01052766|"     In this particular study the physicians want to use a new technique of how they obtain the     PET/CT pictures. It is called breath-hold (BH) PET/CT. As the name suggests, they will ask     the patient to hold their breath for about 20-30 seconds, and only during that time will they     obtain pictures. This is repeated several times. In contrast to the standard PET/CT scan,     they expect less blurring of the pictures, so that they can see the tumor better and     measure the uptake of radioactive sugar in the tumor better and more reliably. Basically,     this is the difference between taking pictures of a runner as compared to taking pictures of     a person standing still. Since PET images need to be obtained over several minutes and people     can not hold their breath for this extended time, we break the procedure into several cycles     of 20-30 seconds (or longer, if possible) and then add all the frozen pictures in the end     into one. They want to know if BH PET/CT scan measure changes in the cancer during therapy     (i.e., from the baseline scan before therapy to the follow up scan at within 4 weeks later).   "
244023|NCT01052779|"     The purpose of the study is to evaluate the safety and efficacy of intravenous (IV)     ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in     subjects with chronic kidney disease (CKD).   "
244024|NCT01052792|"     An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover,     comparative bioequivalence study.   "
244025|NCT01052805|"     1. To explore the pathology of nerve, vasculature in the normal control nerve        2. Compare the pathology of control nerve and nerve from amputated limb of diabetes   "
244026|NCT01053156|"     This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of     age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a     controlled trial of minocycline, an antibiotic commonly used in children for infection or for     treatment of neurodegenerative disorders. We are investigating its use in FXS because it     lowers matrix metalloproteinase 9 (MMP9) levels, which are high in FXS, and it also     strengthens brain connections in the animal models of FXS. We hypothesize that minocycline     will likely be helpful for language, behavior and/or cognition in fragile X patients.   "
244027|NCT01053169|"     Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the     coagulation factors II, VII, IX and X which are important for blood clotting (coagulation).     Lack of any of these factors means that blood does not clot as quickly as it should and so     there is an increased tendency to bleed. This observational study was designed to evaluate     the effectiveness of Beriplex® P/N in the prevention (prophylaxis) and treatment of bleeding     during surgery (perioperative bleeding) in a routine clinical setting.   "
244088|NCT01053975|"     The purpose of this study is to validate the accuracy of the SPIROCOR System in indicating     the presence of significant coronary artery disease (S-CAD), as defined in ACC/AHA     Guidelines, in subjects with suspected S-CAD.   "
244028|NCT01053182|"     Worldwide, esophageal cancer is the 6th most common cause of cancer-related death. Currently     curative resection remains the cornerstone of the therapy. Despite advances in anesthesia,     operative techniques and postoperative management, postoperative pulmonary complications     (PPCs) occur frequently accounting for about 30% of all postoperative complications. Most     importantly, PPCs have much been associated with postoperative mortality. The diaphragm is     the most important respiratory muscle and its respiratory function would be inevitably     damaged when esophagectomy is performed through the left posterolateral thoracotomy (Sweet     procedure) because the diaphragm must be dissected for the purpose of stomach moralization.     Meanwhile, Ivor-Lewis approach may effectively avoid diaphragm injury because the stomach can     be managed through a laparotomy whereas an additional abdomen incision is needed. Both     procedures are routinely used in practice when surgically managing esophageal cancer. The     investigators hypothesize that Ivor-Lewis procedure might be superior to the left-thoracotomy     route during esophagectomy in preventing PPCs.   "
244095|NCT01054066|"     The purpose of this program is to educate primary care physicians in four underserved clinics     in eastern North Carolina about chronic kidney disease.   "
244029|NCT01053195|"     Qingdao Diabetes Prevention Project aims to translate the trial experience to communities     with specific objectives to:        -  raise the public awareness of diabetes and diabetes risk factors        -  promote healthy lifestyle of the entire targeting population        -  reduce the number of people with obesity        -  reduce the number of high-risk people developing diabetes through lifestyle intervention        -  prevent the diabetic complications        -  evaluate the effect and the cost of the community-based prevention project. The project          is community-based targeting at the entire population of 1.94 million living in four          administration districts of the city of Qingdao in China. In the first phase of the          project (2005-2008) the work emphasis is on health promotion, training over 2000 primary          care professionals and 300 school health nurses and establishing a network consisting of          600 community clinics. In the second phase (2008-2012) lifestyle counseling sessions          will be provided to about 242112 high-risk individuals identified, and the efficacy and          the cost of the project will be evaluated at the end of the project in 2012.   "
244030|NCT01053208|"     To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine     citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil® PM, of     Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fasting     conditions.   "
244031|NCT01053221|"     This randomized trial will enroll adult recipients of HLA-identical living kidney transplants     who are at least 1 year post-transplant. All subjects will be taking Prograf (tacrolimus) or     cyclosporine and mycophenolic acid (CellCept or Myfortic) and then be randomized (1:2) to     either continue calcineurin inhibitors or to taper off of calcineurin inhibitors. The     hypothesis is that mycophenolic acid monotherapy permits long-term rejection-free renal     allograft function in the absence of long-term calcineurin inhibitors in this fully matched     renal transplant cohort.   "
244032|NCT01053234|"     The purpose of this study in patients with type 2 diabetes was to investigate the acute     effect of postprandial blood glucose levels modified by two different insulin treatment     regimens on coagulation activation, inflammation and endothelial cell function. The     investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial     postprandial effect on coagulation, endothelial dysfunction and inflammation compared with     the intermediate-acting insulin NPH due to its ability to lower postprandial glycaemia.   "
244033|NCT01053247|"     The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic     Dermatitis.      Treatment medication will be administered as follows: Apply a thin layer of ointment to     affected skin areas twice daily and rub in gently and completely. Study medication will be     applied twice a day, approximately 12 hours apart, for approximately 2 weeks.   "
244034|NCT01053260|"     Rates of overweight and obesity are increasing, particularly among individuals aged 18 to 29.     An estimated 25-35% of American college and university students are overweight or obese.     Contingency Management (CM) is a behavioral intervention that provides tangible rewards for     positive behaviors. CM has substantial evidence of efficacy in reducing smoking and drug use     and increasing treatment retention and medication compliance. The current study will evaluate     the efficacy of a 24-week CM intervention to promote weight loss in overweight and obese     university students. Seventy participants with a body mass index (BMI) of 27.0-34.9 will be     randomly assigned to one of two conditions: (a) LEARN, a manual guided behavioral weight loss     program (Brownell, 2004), with weigh-ins and supportive counseling, or (b) LEARN with     weigh-ins and supportive counseling plus CM. Participants in the CM condition will earn     chances to win prizes each week in which they lose at least one pound. Once they lose 5% of     baseline body weight, they will earn chances to win prizes for weight loss or weight     maintenance. Additional chances can be earned by completing activities that promote weight     loss. The primary outcomes will be absolute and proportional weight loss from pre- to     post-treatment, as well as proportion of participants achieving clinically significant weight     loss (>5% of baseline weight) and proportion moving into a lower risk BMI category. Secondary     outcomes will include length of retention in the study, increase in physical activity level,     and improvement in nutritional quality of diet. Effects of the CM intervention on psychiatric     distress and self-efficacy and motivation to engage in activities that promote weight loss     will also be assessed. We predict that participants in the CM condition will lose more weight     than participants assigned to the LEARN program without CM, and that more CM participants     will achieve clinically significant weight loss. We also predict that participants in the CM     condition will remain in the program longer, show larger increases in physical activity, show     greater improvements in diet quality, and have greater increases in levels of self-efficacy     and motivation than comparison group participants. Mediators and moderators of CM outcomes     will also be evaluated. If efficacious in promoting weight loss in a college population, CM     could help to prevent or delay later development of obesity-related medical problems.   "
244035|NCT01053273|"     The purpose of this study is to:        -  evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low          back and/or lower extremity pain in patients without post lumbar surgery syndrome or          spinal stenosis and compare with fluoroscopically directed caudal epidural steroid          injections.        -  evaluate and compare the adverse event profile in all groups.   "
244036|NCT01053286|"     This is a research study to learn more about whether capsaicin, a natural ingredient of chili     peppers that makes them taste hot, can improve swallowing function. The purpose of this     study is to evaluate whether sucking on a capsaicin lozenge improves sensation in the throat     enough to improve swallowing function.   "
244089|NCT01053988|"     The Purpose of this study is to assess the efficacy and safety of two strengths of the     FF/GW642444 Inhalation Powder in subjects with chronic obstructive pulmonary disease (COPD)   "
244090|NCT01054001|"     The investigators try to investigate the benefit of early administration (immediately after     urethral catheter removal) of sildenafil after nerve-sparing RALP for 3 months. The     investigators will compare the potency rates up to 2 years after nerve-sparing RALP in men     with on- demand sildenafil 100mg dosing from the early postoperative period (immediately     after urethral catheter removal) with from the delayed postoperative period (3 months after     RP).   "
244037|NCT01053299|"     All newborn from the period 12.1988 to 31.12.2006 During the two last decades, hip ultrasound     has gained acceptance as an accurate screening test for developmental dysplasia of the hip     (DDH) and for monitoring the development and treatment of the condition. Debate continues     over whether DDH that is detected by ultrasonography is necessarily clinically relevant. The     diagnostic accuracy of ultrasound imaging for DDH in the screening population has not been     investigated adequately. Studies that investigate the natural course of the disorder, the     optimal treatment for DDH, and the best strategy for ultrasound screening are needed.     Ultrasound screening at birth for DDH in all newborn infants is standard practice in some     European countries but not in the United Kingdom, the United States, or Scandinavia. Evidence     is insufficient to support or reject general ultrasound screening of newborns for DDH.     (N.F.Woolacott etc 2006, systematic review BMJ) At Vestre Viken HF, Kongsberg, Norway, the     investigators implemented universal ultrasound screening in 1998. We will present the long     term outcome, including radiographs of the hips after 5-12 years.   "
244039|NCT01053325|"     Malaria is a major contributor of disease burden in Sub-Saharan Africa: 90% of global cases     occur there, and pregnant women and children under 5 years are the most vulnerable. Malaria     in pregnancy increases risks of abortion, stillbirth, prematurity, intrauterine growth     retardation and maternal anemia, and is associated with higher risk of low birth weight and     perinatal, neonatal and infant mortality. For prevention and control of malaria in pregnancy,     the WHO recommends Intermittent Preventive Treatment (IPT) with antimalarial drugs,     insecticide treated nets (ITNs) and effective treatment of malaria and anemia.      HIV in pregnancy increases the risks of malaria, and it seems that the efficacy of IPT with     the drug sulphadoxine-pyrimethamine (SP) is decreased in HIV+ pregnant women.      Malaria prevention in pregnancy in Zambia relies on ITNs and IPT with SP. Daily prophylaxis     with cotrimoxazole (CTX) effectively reduces mortality and morbidity in HIV+ individuals, and     antibiotic therapy during pregnancy might help to decrease adverse pregnancy outcomes. CTX     prophylaxis improves birth outcomes in HIV+ women with CD4<200/µl: a study concluded that     antenatal provision of CTX was beneficial for HIV+ pregnant women with low CD4 but not in     women with ≥200/µl (however, this study was carried out in an area with very low risk of     malaria , and CTX may have a different effect depending on endemic conditions). The WHO     recommends daily CTX in addition to ARVs, to prevent opportunistic infections in all HIV+     patients.      Concurrent administration of SP and CTX may increase the incidence of severe adverse     reactions in HIV+ patients, so WHO has promoted CTX prophylaxis as an alternative to SP for     the IPT in immuno-compromised pregnant women. Unfortunately, there is insufficient     information on the effectiveness of daily CTX for preventing malaria infection in pregnancy:     so, SP is still the only antimalarial recommended by WHO for this purpose. With the increase     in SP resistance and with the newer antimalarials still being studied for safety and efficacy     in pregnancy, CTX could be an alternative for SP in reducing malaria and malaria-related     morbidity and mortality in pregnancy.      This study will try to to see if in HIV- and HIV+ pregnant women, CTX is not inferior to SP     in reducing placental parasitaemia. Such information is needed to issue updated, effective     guidelines on malaria prevention in pregnancy   "
244040|NCT01053338|"     To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine     citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil®PM, of     Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fed     conditions.   "
244041|NCT01053364|"     The purpose of the study is to evaluate the clinical safety and feasibility of the NL-Prow™     Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal     stenosis   "
244042|NCT01053377|"     The incidence of severe morbidity and mortality following an influenza infection during the     annual influenza epidemics is highest among the elderly population and 90% of     influenzaassociated mortality occurs in this group. Vaccination is considered the best     preventive intervention available but offers only partial protection. The protective effect     decreases with advancing age and existing co-morbidity. Therefore, in spite of high     compliance with vaccination, the risk of influenza-related complications among nursing-home     residents, is particularly high, and consequently also the associated disease and economic     burden. There is debate on the potential health benefit of the antiviral activity of     oseltamivir as an effective supplementary intervention to prevent or contain influenza     outbreaks in nursing homes. Although effectiveness of post-exposure prophylaxis (PEP) with     oseltamivir on preventing transmission has been demonstrated in trials among healthy (mainly     unvaccinated) adults and children, effectiveness has not yet been assessed among vulnerable     vaccinated highrisk groups, such as the elderly population in nursing homes. If proven     (cost)effective, oseltamivir could have considerable benefits in this setting, although     constraints relating to implementation need to be addressed as well.   "
244043|NCT01053390|"     Objective Primary:      Determine the objective response rate in patients with advanced gallbladder treated with new     Chemotherapy regimen      Secondary:      Determine time to progression-free survival and overall survival of patients treated with     this regimen.      Determine quality of life of patients treated with this regimen. Determine the toxicity of     new chemotherapy regimen   "
244044|NCT01053403|"     The purpose of this study is to measure the effects of MDMA on sleep, mood, thinking, and how     your body retains water. The researchers are interested in the effects that occur a few hours     after taking MDMA as well as effects occurring over the next two days. We will study these     effects in a standardized, controlled setting at the Clinical and Translational Science     Institute (CTSI) Clinical Research Center (CRC) located at San Francisco General Hospital.      The primary hypotheses are:        1. MDMA will induce sleep disruption, as indicated by comprehensive polysomnography, wrist          actigraphy, and self-report sleep measures        2. MDMA will alter sodium and water homeostasis by either increasing or blunting the          suppression of arginine vasopressin levels and decreasing free water excretion. Effects          will be exacerbated by water loading.      Secondary hypotheses:        1. Acutely, MDMA will increase both positive and negative arousal, and to increase          sociability but not autonomy.        2. Acutely, MDMA will increase risk-taking and willingness to donate money to others in an          economic decision making task.        3. MDMA will decrease the stressful effects of talking about a negatively-valenced          autobiographical but will increase recall for details for these episodes.        4. MDMA will increase oxidative stress markers and possible ameliorating factors (e.g.,          ADMA).        5. The short form of the serotonin transported promoter region will be associated with          greater acute and discontinuation effects of MDMA.   "
244045|NCT01053416|"     STUDY AIMS        1. To determine the 10-year conversion rate from pigment dispersion syndrome (PDS) to          pigmentary glaucoma (PG)        2. To evaluate the possible protective effect of a Yag-laser iridotomy   "
244047|NCT01053442|"     Several iron compounds are used for fortification, including ferrous sulphate and NaFeEDTA.     The absorption profile of these may differ because of differences in their dissolution in the     gastrointestinal tract and in their interaction with dietary inhibitors of iron absorption.     As these differences might lead result in varying reactions in the blood stream, the     appearance rate of the stable iron isotope, hepcidin, non-transferrin-bound iron and total     iron in the plasma will be monitored over six hours in adult women. This is relevant as a     spike of absorbed iron may increase non-transferrin-bound iron and this could be     pro-oxidative or increase growth of pathogens. Hepcidin is a key mediator of iron absorption     and will help explain the potential differences in the plasma iron profile.      The use of stable iron isotope appearance curves to specifically detect the appearance of     small amounts of absorbed iron in the blood and distinguish between circulating body iron and     iron absorbed from the test meal was tested in a pilot study (EK 2008-23). This method is now     used in a bigger sample to test the differences in absorption profile of ferrous sulphate,     FePPi and NaFeEDTA given at fortification level with a meal.   "
244048|NCT01053455|"     Investigation of effects of SiPAP versus NCPAP on oxygenation and ventilation in LBW infants     with respiratory distress. Our hypothesis is that the LBW infants will achieve the same level     of oxygenation and improved ventilation when being treated with SiPAP as compared to NCPAP.   "
244049|NCT01053468|"     Breast cancer and its treatments can take a toll on the physical and psychosocial well-being     of cancer survivors. Few interventions can help breast cancer patients improve their physical     strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during     chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer     patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This     trial will also give Southern Alberta breast cancer survivors an opportunity to participate     in evidence-based programs designed to facilitate their health, breast cancer recovery, and     disease-free survival.      The investigators primary hypothesis is that women receiving the PA intervention resource kit     will report a more positive change in self-reported PA at the end of chemotherapy treatments     when compared to the group receiving standard materials.   "
244050|NCT01053481|"     The purpose of this study is to determine whether increasing levels of serum 25(OH)Vitamin D     as achieved by oral supplementation higher than the current recommendations are associated     with a less negative bone calcium balance in post-menopausal Swiss women.   "
244051|NCT01053494|"     This clinical trial studies massage therapy given by caregiver in treating quality of life of     young patients undergoing treatment for cancer. Massage therapy given by a caregiver may     improve the quality of life of young patients undergoing treatment for cancer   "
244052|NCT01053507|"     This study will evaluate the effectiveness of Treximet when taken for post traumatic headache     by measuring any change in the number of headache days or any change in a subject's ability     to think following treatment with study medication. Eligible subjects will complete 3 visits.     Following Visit 1, subjects will treat with their usual medication and document headache     symptoms and therapy in a Headache Diary. After 30 days, subjects will return for Visit 2 and     be randomized (like the flip of a coin) to receive Treximet or matching placebo to treat at     the same time each day. Treximet will be provided to treat any headache that occurs. Subjects     will complete a daily Diary. After 30 days, subjects will exit the study at Visit 3.   "
244053|NCT01053520|"     This is a Phase 1, randomized, open-label, single center, three period crossover study to     determine the oral bioavailability of a new ABT-263 formulation relative to that of the     current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately     12 healthy female subjects will be enrolled in this study.   "
244054|NCT01053533|"     The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines     for severe pandemic H1N1 influenza.   "
244055|NCT01053546|"     RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck     cancer patients undergoing chemotherapy or radiation therapy.      PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise     therapy to see how well it works compared to late onset of swallowing exercise therapy in     treating patients with head and neck cancer undergoing chemotherapy or radiation therapy.   "
244056|NCT01053559|"     Wireless Capsule Endoscopy has been the most reliable diagnostic standard for small bowel     Crohn's disease. Endoscopic healing is an important endpoint to measure response to     treatment.   "
244057|NCT01053572|"     To evaluate the effectiveness of steroids and/or 10% hypertonic sodium chloride in     percutaneous adhesiolysis in managing chronic low back and/or lower extremity pain in     patients with post lumbar surgery syndrome.      To evaluate and compare the adverse event profile in all groups.   "
244058|NCT01053585|"     Aims of research project:      To identify key features of the gastro-esophageal junction (structure and function) that     protects the esophagus from gastro-esophageal reflux investigated by combined high resolution     manometry and magnetic resonance imaging.      Hypothesis:        1. Functional factors including GEJ function (e.g. sphincter pressure) and proximal gastric          distension determine whether or not TLESR occurs; however        2. Structural factors including separation of GEJ anatomy, intra-gastric distribution of          the meal and secretions determine whether TLESR is accompanied by no reflux event, gas          reflux (belching) or reflux of ingested food and gastric secretion ('true reflux').        3. Initial findings by descriptive studies in healthy volunteers (study #1) and patients          with mild to moderate gastro-esophageal reflux disease (study #2) will be further          interrogated by a randomized, double-blind control trial of baclofen in patients with          GORD; a medication that inhibits reflux by effects on GOJ function (study #3) .   "
244091|NCT01054014|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics     (how the drug is absorbed in the body, how it is distributed within the body and it is     removed from the body over time) of single and multiple doses of JNJ-40346527 in healthy     volunteers. This study will also investigate the pharmacokinetics of JNJ-40346527 with and     without food.   "
244092|NCT01054027|"     The purpose of this study is to compare the dilating effect of 0, 1, 2 or 3 drops of     mydriatic (pupil dilating) in premature infants undergoing routine retinal (eye) screening     exams for Retinopathy of Prematurity (ROP).   "
244059|NCT01053598|"     The Principle objective of this study is To evaluate the performance of NRA, NRA-p and REMA-p     for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB     suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard.      The Secondary objectives are:        -  To measure the performance of each assay (NRA, NRA-p, REMA-p) in sputum smear-negative          patients        -  To describe the results of the colorimetric methods in HIV-positive and HIV-negative          patients        -  To assess the time to detection of both NRA/NRA-p, REMA-p methods.        -  To evaluate the feasibility of the NRA, NRA-p, REMA-p methods.        -  To determine the rate of contamination of the NRA, NRA-p and REMA-p assays.        -  To evaluate the proportion and the clinical relevance of NTM among TB suspects in a high          TB and HIV prevalence setting.        -  To provide capacity building for TB diagnosis in Mbarara.   "
244060|NCT01053611|"     The aim of this study is to compare the accuracy of the changes in CVI in response to a     standardized noxious stimulus during various targeted pseudo-steady-state concentrations of     remifentanil and various steady state level of BIS as guided by propofol effect compartment     controlled TCI (closed-loop).   "
244061|NCT01053624|"     This protocol has been designed to determine if tracheostomy performed immediately after lung     operation (i.e. concomitant tracheotomy) could improve the postoperative outcome of high risk     patients. We hypothesized that concomitant tracheotomy could reduce the length of mechanical     ventilation and the number of respiratory complications.   "
244062|NCT01053637|"     The purpose of this study is:        -  To determine whether oral narcotic medication versus placebo improves the pain and          anxiety scores for pediatric patients requiring laceration repair in the pediatric          emergency department and receiving the standard of care with lidocaine treatment        -  To evaluate for a statistical difference in pain scores in children during laceration          repair        -  To evaluate for a statistical difference in State-Trait Anxiety Inventory for Children          (STAIC) scores during laceration repair   "
244063|NCT01053650|"     Paracetamol is one of the most commonly used drugs in the world, indicated for the     symptomatic treatment of fever and pain of mild to moderate. More precisely, it is a drug     used to relieve pain and reduce fever. The objective of this study is to analyze whether a     placebo effect occurs when you take paracetamol for pain, ie if the analgesic effect of     paracetamol is partly due to the simple fact of taking a drug.      Moreover, during the study you propose to do a saliva sample, optional, for biological     research, pharmacogenetics, to assess how paracetamol is processed and eliminated in your     body..   "
244064|NCT01053663|"     This open-label study will assess the pharmacokinetics and safety of oseltamivir [Tamiflu] in     3 cohorts of infants, aged 0-30 days, 31-90 days and 91-<365 days with influenza infection.     Patients will receive 10 doses of intravenous oseltamivir [Tamiflu] therapy over 5 or 6 days.     Optional oral therapy with oseltamivir [Tamiflu] may be considered following the intravenous     dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at     day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration.     Anticipated time on study drug is 5-11 days. Target sample size is <50 patients.   "
244065|NCT01053676|"     The study is conducted as a randomized, non-blinded, 2-way crossover study. Target population     is 60 Japanese healthy male adult subjects selected by screening examination which will be     conducted within 4 weeks before the first drug administration of period 1 (before the     hospitalization of period 1). Subjects will admit in the clinical institute on Day -3 and be     discharged on Day 6 in each period. During hospitalization, standardized phosphate diet from     Day -2 to Day 4 will start approximately 20 minutes before dosing. Subject will take about     1300 mg of phosphate evenly at breakfast lunch and dinner for each day. Subject should     consume at least 95% of a meal. Distilled water not to include phosphate will be used for     drinking water and meal. Subjects are to drink at least 1 L of distilled water every day in     clinic to make sure enough urine volume. The 24 hours urine collection will be conducted     between Day -2 and Day 4 to investigate the urinary phosphate excretion.BAY77-1931 granule     500 mg or Fosrenol chewable tablet 500 mg will be administered three times daily after each     meal from Day 1 to Day 4. On day 4 single dose after breakfast will be administered. Study     drugs will be administered immediately after each meal, that is within 20 minutes after start     of each meal with 240 mL of distilled water. A Fosrenol chewable tablet 500 mg will be taken     after chewing completely.   "
244066|NCT01053689|"     The purpose of this bioequivalence study is to compare a test Glimepiride 1 mg tablets of     Dr.Reddy's Laboratories Limited versus reference Amaryl 1 mg tablets of Aventis     Pharmaceuticals Inc in healthy subjects, under fed condition.   "
244067|NCT01053702|"     This is a randomized, double-blind, placebo-controlled, parallel-group, single-dose study of     the efficacy of REGN475 in patients with pain due to thermal injury.   "
244068|NCT01053715|"     The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents     and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The     study will also assess the kinds of determinants, including key transitional life events,     that might impact HRQoL in this patient population.   "
244069|NCT01053728|"     Primary Objective:      - To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles     of four formulations of SAR161271 in patients with T1DM.      Secondary Objective:      - To establish relative potency of SAR161271 compared with insulin glargine in patients with     T1DM   "
244070|NCT01053741|"     This research is being done to learn how seminal fluid affects the lining of the colon, and     whether this might make it easier for HIV to get into the body and cause infection.   "
244133|NCT01054560|"     The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR     Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval     System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™     Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.   "
244134|NCT01054573|"     The purpose of this study is to provide access to telaprevir for patients from the control     group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and     tolerability of telaprevir in combination with standard treatment will be evaluated.   "
248942|NCT01114737|"     This double-blind, placebo-controlled, randomized study is designed to evaluate the safety     and therapeutic effects of sapropterin dihydrochloride on neuropsychiatric symptoms in     subjects with PKU.   "
244071|NCT01053754|"     The study (forward-looking and opened) will concern 70 subjects having had a systemic     prolonged treatment with corticosteroids for intestinal chronic inflammatory disease,     recruited in the services of gastroenterology and endocrinology of the North Hospital of     Marseille (France). The primary objective of the study is to estimate a new test, the long     synacthen stimulation test, using an IM injection of 1 mg of delate synacthen, with regard to     the definitive standard. Indeed, this long test could be realized in ambulatory conditions,     and turn out more contributory than the definitive standard to estimate the capacities of     answer of the adrenal glands in front of a prolonged stress, as it is the case during a     surgical procedure for example.      The secondary objectives are: 1) to determine the relation between the value of basal     cortisol and the peak of stimulation of cortisol during short and long tests. This could     allow to clarify better the conditions in which it is absolutely necessary to realize a     dynamic test, 2) to determine the relation between cortisol assay in the plasma and in the     saliva. The sample of saliva is simple and non-invasive, and presents the advantage to be     able to be realized in ambulatory conditions and by the patient himself.      The cortisonic withdrawal syndrome is another complication which can arise when a prolonged     corticosteroid therapy is discontinued. Clinically, it looks like a chronic adrenocortical     insufficiency, but with normal ranges of plasma cortisol. It is probably in touch with a     physical dependence to the taking of above physiological doses of GC over a long period. Its     physiopathology remains badly known, but could bring in a deficit of secretion of DHEA-S     (dehydro-epiandrosterone sulphate), another hormone secreted by the adrenal glands. One of     the secondary objectives of the study will consist in informing the variations of DHEA-S     after a prolonged corticotherapy, in the basal state and after stimulation by the long     synacthen stimulation test.   "
244072|NCT01053767|"     This study looks at the body's immune response to a GBS vaccine 2 years after the orginal     vaccine(s) were given in the V98P2 study. Blood will be drawn and evaluated for GBS antibody     levels.   "
244073|NCT01053780|"     Intercessory prayer can improve the outcome of pregnancies?   "
244075|NCT01053806|"     To evaluate the overall response rate of the combination of 5-azacitidine + Lenalidomide in     high risk MDS patients (INT-2 and High risk defined by IPSS), and patients with low and int-1     who are considered to be at high risk due to unfavorable additional factors.        -  To evaluate the safety of the combination of 5-azacitidine + Lenalidomide in high risk          MDS patients.        -  To evaluate the hematological improvement rate.        -  To evaluate the cytogenetic response rate.        -  To evaluate the Progression free survival (PFS).        -  To assess Quality of life.   "
244076|NCT01053819|"     In psoriasis patients, thick psoriatic plaques can obscure these lesions, and clinicians rely     heavily on visual inspection to recognize suspicious or atypical pigmented lesions. However,     successful systemic treatment and subsequent clearing of psoriatic plaques may allow     clinicians to better evaluate pigmented lesions, thereby increasing the likelihood of early     identification and treatment of suspicious lesions such as nonmelanoma skin cancer and     malignant melanoma.   "
244077|NCT01053832|"     Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.   "
244078|NCT01053845|"     Several studies showed that activity of down inhibitor bundle is weakened in different     painful pathologies as the fibromyalgy or the trigeminal nevralgy.      The purpose of the protocol is to study the working of down inhibitor bundle at patients     suffering of neuropathic pain.   "
244079|NCT01053858|"     To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the     treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.   "
244080|NCT01053871|"     This trial aims to compare the endomicroscopic image quality and sedation efficacy of     propofol or midazolam with fentanyl.   "
244081|NCT01053884|"     Study objectives To evaluate the safety of the echinocandin anidulafungin for prophylaxis or     treatment of invasive fungal infections (IFI) in hematologic patients.      Study design, Study conduct period Prospective, open label, phase II, one arm, single centre     study October 2009 - September 2010      Study population Twenty adult patients (≥ 18 years) with a hematologic disorder and an     indication for antifungal prophylaxis or therapy, but a relative contraindication for azoles     or polyenes due to hepatic and renal dysfunction respectively      Methods and Main Out-come Variables Main Outcome Parameter Safety: Adverse events and changes     of important laboratory parameters with clinical impact will be reported.      Secondary Outcome Parameter Efficacy: In therapeutically use the outcome will be categorized     into success or failure. For patients receiving anidulafungin as prophylaxis the number and     rate of breakthrough infections will be documented.      Risk assessment Treatment related adverse effects as reported in the approved physician     prescribing information (usually mild and with an incidence of < 5%). Treatment failure due     to resistant pathogens.      Expected benefit from this study IFI is a major cause of death among hematological patients,     especially those undergoing high dose chemotherapy. It is conceivable that anidulafungin is a     new treatment option for patients in whom azoles or polyenes are relatively contraindicated.   "
244082|NCT01053897|"     The primary objective of this study is to assess whether intradermal injections of GBT009     along full thickness incisions following surgery results in an improvement in scar     appearance.   "
244083|NCT01053910|"     The objective is to investigate the safety of ramipril 10 mg/day used in prevention of     cardiovascular events in high-risk patients, including the criteria of the HOPE study.   "
244084|NCT01053923|"     The purpose of this study is to establish a prospective database of anal canal and perianal     cancer patients treated with IMRT and chemotherapy with curative intent at PMH for the     purposes of investigating MRI-derived primary tumor parameters. Patients who decide to     participate in this study will be treated according to standard treatment policies and     radiation therapy planning protocols at Princess Margaret Hospital (PMH) with radiation     therapy +/- chemotherapy. IMRT for all treatment phases of radiotherapy has been implemented     as standard treatment. Surgery is reserved for salvage treatment.   "
244085|NCT01053936|"     This study assesses the effects of a new formulation of bardoxolone methyl on eGFR in     Patients with Chronic Kidney Disease and Type 2 Diabetes.   "
244086|NCT01053949|"     The purpose of this study is to evaluate the response to pomalidomide and dexamethasone in     relapse and refractory MM patients who are progressive and did not achieve at least a partial     response to bortezomib and lenalidomide. This study will determine the efficacy and toxicity     profile of 2 modalities of pomalidomide in patients with advanced myeloma, previously heavily     treated characterized with adverse prognostic and that are in desperate need of novel     therapeutics.   "
244087|NCT01053962|"     This is a Phase IIa, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose     ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD)     effects of SP-304 in patients with chronic idiopathic constipation.   "
244093|NCT01054040|"     The study will involve cardiac rehabilitation clients and will measure their weight, height,     waist circumference and blood pressure comparisons between first and final visit (after 8     weeks). A control group will receive usual care and an experimental group will receive usual     care plus a portion control plate for their meals. Patients currently have their waist     circumference, weight, height and blood pressure measured at their first visit (week 0) and     at their final visit (week 8). This study would compare these three parameters at these same     times (week 0 and week 8) between the control and experimental groups. The control group     would receive the usual care while the experimental group would receive usual care plus be     given a portion control plate at week 0.      The hypothesis of this study is that subjects from the experimental group will have an     average reduction in: (a) waist circumference by > 5%, (b) weight or BMI by > 5%, and (c)     systolic and diastolic blood pressure by >10%. The subjects in the control group are     hypothesized to show an average less than these targets for the experimental group.   "
244094|NCT01054053|"     The main objective of the study is to estimate the proportion of children, born between the     06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with     a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4),     before the first vaccination (T0), after the second MenBvac vaccination (6 weeks after the     second vaccination), before the third MenBvac vaccination and after the third MenBvac     vaccination (6 weeks after the second vaccination) and one year after the third menBvac     vaccination.   "
244098|NCT01054105|"     In the present study, the investigators want to investigate the prevalence of BMPR-2 gene     mutations in the Korean PAH patients (Step-I) and to test that the PAH patients treated with     iloprost inhalation solution (Ventavis®) would show hemodynamic response, especially assessed     by exercise echocardiography (Step-II).   "
244099|NCT01054118|"     This study will assess the safety, tolerability, pharmacokinetics (explores what the body     does to the drug), and pharmacodynamics (explores what a drug does to the body) of single     doses of JNJ-38431055, sitagliptin, and co-administration of JNJ-38431055 and sitagliptin in     healthy overweight or obese adult male volunteers.   "
244100|NCT01054131|"     Inflammatory arthritis (IA) is a major cause of long-term disability. Peer support may be a     solution to the common problem of delayed treatment. Early peer support may result in     improved use of therapy, higher self-efficacy, reduced anxiety, and improved coping in the     first two years post-diagnosis. The whole intervention study comprises of two parts: The     first part involves the development and testing of a peer mentor training initiative, which     is called Peer to Peer Mentoring: Facilitating Individuals with Early Inflammatory Arthritis     to Manage their Arthritis - Peer Mentor Training. The second part, which is the focus of     this study, involves the delivery of a one-on-one peer support intervention from a trained     peer mentor to an individual newly diagnosed with EIA. The feasibility and acceptability of     the program will be determined, as well as the health outcomes following the participation of     the program.   "
244101|NCT01054144|"     The purpose of this research is to estimate the effectiveness of a response adapted approach     with the use of the drug, lenalidomide in the treatment of older adults with newly diagnosed     standard risk multiple myeloma. This means that participants will be given the study drug,     lenalidomide but depending on how they respond to this drug they may also be given     dexamethasone and/or prednisone to help with their treatment.   "
244102|NCT01054157|"     to approve the expression of PGF2α receptors in hair follicle in ocular skin tissue,     explaining the hypertrichotic effect of PG analogues as intraocular pressure lowering     treatment.   "
244103|NCT01054170|"     The primary objective of the study is to evaluate structural changes effected by AD9668 in     the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice     Computed Tomography (MSCT)   "
244104|NCT01054183|"     This study seeks to assess the role of the GlideScope Ranger video laryngoscope in     facilitating successful neonatal/pediatric intubation by pediatric critical care transport     teams. The central hypothesis of this study is that the GlideScope Ranger video laryngoscope     reduces the rates of failed intubation attempts by pediatric critical care transport teams.     The aims of this project are designed to specifically: (1) Establish competencies for     GlideScope Ranger video laryngoscopy-assisted intubation for pediatric and neonatal patients;     and (2) Compare the intubation success rates for intubation using GlideScope Ranger video     laryngoscopy and using conventional, direct laryngoscopy by pediatric and neonatal critical     care transport teams.   "
244105|NCT01054196|"     A) Phase 1: To determine the maximal tolerated dose (MTD) of lenalidomide that can be safely     added to high-dose melphalan prior to autologous stem cell transplantation (ASCT).      B) Phase 2: To determine whether the addition of high-dose lenalidomide to ASCT followed by     maintenance standard-dose lenalidomide improves the response rate and duration of response     for relapsed multiple myeloma (RMM).   "
244143|NCT01054690|"     This study is a single blinded (Outcome Assessors), multicenter randomized controlled study     designed to investigate if a silver alloyed urinary catheter with antibacterial properties     can reduce the incidence of catheter acquired urinary tract infections in patients undergoing     elective surgery. Patients requiring urinary catheterization will be randomized into two     groups and receive either the silver alloyed catheter (test) or a silicone catheter     (control).   "
244144|NCT01054703|"     Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access     system   "
244145|NCT01054716|"     This study will collect whole blood samples from pregnant subjects who are RhD negative by     serology to develop an assay for RHD determination of the fetus.   "
244106|NCT01054209|"     This study will demonstrate whether an electric warming mattress can reduce the number of     patients who get cold and shiver after elective cesarean section.      Peri-operative hypothermia (body temperature below 36 ºC) is a cause of post-operative     complications and patient discomfort. Immediately post-operatively such discomfort is due to     increased pain and shivering. Patients say that their time in the recovery ward is very     stressful and this is prolonged if they become cold (hypothermic)or shiver. Subsequently,     patients can suffer with increased risk of infections and delayed discharge from hospital.      For patients (and their babies) having Cesarean sections it is important to start breast     feeding as soon as possible, but being cold may delay this.      For some types of surgery measures are put in place to stop patients becoming cold and     thereby reduce the number of problems. However this is not the case with patients undergoing     Cesarean sections because the special blankets through which hot air is blown to keep them     warm are inappropriate for mothers giving birth by Cesarean section as it would make it     difficult for a mother to have good skin-to-skin contact with her new baby immediately after     delivery - an important part in the bonding process.      A solution is to use a new warming mattress. This has been shown to be safe and effective     with some types of surgery, but has not been tested in Cesarean sections.      In the investigators study,the investigators will warm a group of patients undergoing planned     Cesarean section and compare them to an unwarmed group to see if there is any difference     primarily in post-operative temperature. Secondarily, the investigators will also look for     differences in total blood loss, incidence of blood transfusion, wound infection, shivering,     the immediate health of the baby, time taken to become fit for discharge from recovery,     length of hospital stay and time to breast-feeding.   "
244107|NCT01054222|"     This is an open-label extension study intended for subjects who have previously completed     study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the     investigator as being suitable for the extended use of Fesoterodine. Data from this study     will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older     subjects from Portugal.   "
244108|NCT01054235|"     The general objective of this study is to evaluate prenatal care in the specific context of     rural China. It also aims to define the optimal content of prenatal care for the context of     rural China, to evaluate the effect of such prenatal care on infant and maternal outcomes,     using a community based, well designed controlled trial in rural counties. Finally, it aims     to describe the process of conducting a controlled study using community resources.   "
244124|NCT01054443|"     This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging,     parallel-group study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics     of S-888711 in the treatment of subjects with immune thrombocytopenia. Eligible subjects will     be randomized into one of four treatment groups to receive S-888711 0.5 mg, 0.75 mg, or 1.0     mg or placebo.   "
244109|NCT01054248|"     This is a randomised, open label trial, comparing standard dose of     dihydroartemisinin-piperaquine (DP) with standard fixed artesunate-mefloquine regimen (MAS3)     and with a longer regimen of artemether-lumefantrine (ALN+) in the treatment of uncomplicated     malaria in pregnant women. The sample size is 335 women in each arm which would be 1005 women     in total. Pregnant patients in 2nd and 3rd trimester with acute uncomplicated malaria who     meet eligibility criteria will be asked to participate in the study. The primary objective is     to determine if the efficacy of DP and MAS3 are superior to ALN+ in the treatment of     uncomplicated malaria in pregnancy. The study will also incorporate a dense pharmacokinetic     study of mefloquine and artesunate (15 women in the MAS3 arm) and a population     pharmacokinetic study for mefloquine, piperaquine and lumefantrine.   "
244110|NCT01054261|"     The objective of this study is to compare the pharmacokinetics of avanafil in subjects with     mild and moderate renal impairment and to assess the safety and toleration of avanafil in     subjects with mild and moderate renal impairment.   "
244111|NCT01054274|"     Esophageal cancer is common in some areas , ranking as the fourth leading cause of death from     cancer in China and sixth worldwide. Although the prognosis of surgical resection for     esophageal cancer has been improved, more than 50% of such patients are inoperable and have     to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the     predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia     and improve the quality of life of such patients, brachytherapy has previously been utilized.     Recently, stent placement has been widely accepted to be an option for palliation of the     symptoms due to the esophageal strictures. Brachytherapy and esophageal self-expanding stent     insertion have longer benefit. Stent insertion provides fastest improvement of     dysphagia.However, recurrence of the neoplastic stricture remains a challenge after stent     placement, complications in later setting occur and require further endoscopic treatment.     Brachytherapy has slower onset of benefit but has fewer complications and longer benefit.To     combine the advantages of the immediate relief of the esophageal dysphagia with the stent     placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I     seeds has been developed in the authors' institute. The technical feasibility and safety with     this new stent has been demonstrated to be adequate in a healthy rabbit model. And a     small-sample and unicentric prior clinical trial in the authors' institute certificated the     novel esophageal stent can relieve the dysphagia caused by advanced esophageal cancer rapidly     and improve the quality of life markedly. This current multicentric randomized clinical trial     is further studying the novel esophageal stent loaded with 125I seeds to see how well they     work compared with a conventional covered stent in patients with malignant dysphagia caused     by advanced esophageal cancer.   "
244112|NCT01054287|"     The aim of this study is to evaluate the effect of a multifactorial falls prevention program     in an acute internal medicine ward.   "
244113|NCT01054300|"     This is a Phase 1 pharmacokinetic, pharmacodynamic study to understand the manner in which     the body responds to, as well as how the drug is handled by the body, with once vs twice     daily dosing of ertugliflozin (PF-04971729, MK-8835) in participants with type 2 diabetes.   "
244114|NCT01054313|"     The goal of this clinical research study to find the highest tolerated dose of the     combination of Taxotere (docetaxel) and Rapamycin (sirolimus) when given to patients with     advanced cancer.      Researchers also want to find highest tolerated dose of the combination of docetaxel,     sirolimus, and prednisone when given to patients with advanced prostate cancer. The safety of     both drug combinations will also be studied.   "
244115|NCT01054326|"     The objective of this study was to evaluate and compare two different post-surgical     rehabilitation strategies, Rehabilitation supervised by a physical therapist including     exercises with progressive early activation of the rotator cuff versus basic home exercises     regarding shoulder function, pain, health related quality of life and return to work after     arthroscopic subacromial decompression.   "
244116|NCT01054339|"     This study will evaluate the safety and efficacy of a recombinant adeno-associated virus     vector expressing alpha-1 antitrypsin in patients with alpha-1 antitrypsin deficiency. Three     groups of three subjects each will receive the study drug by intramuscular injection, with     progressively larger doses in the second and third groups.      Funding Sources - FDA OOPD and NIH NHLBI   "
244117|NCT01054352|"     A single and multiple dose study to assess the safety of JNJ 38224342 compared to placebo in     healthy volunteers and in volunteers with seasonal allergies.   "
244118|NCT01054365|"     In comparison to delayed hospital discharge, a strategy of early hospital discharge of     patients who undergo single and multivessel stenting for type A, B, and C lesion(s) using     thienopyridine and a hemostatic femoral closure device, is associated with similar clinical     outcomes, but greater patient satisfaction and similar cost.   "
244119|NCT01054378|"     The temporary diaphrgmatic dysfunction will occur after stellate ganglion block(SGB) and will     be easily detected by M-mode ultrasonography   "
244120|NCT01054391|"     The purpose of this study is to determine whether the NEC device can effectively occlude the     intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel     patency   "
244121|NCT01054404|"     Increased brain bulk may be problematic during brain surgery for tumors because it may limit     surgical exposure and access to the surgical site. Mannitol, an osmotic diuretic, is commonly     given to alleviate brain bulk, and sometimes furosemide in a small dose is added if mannitol     alone is insufficient. It is unclear if adding this furosemide truly helps to diminish brain     bulk, and it is possible that furosemide may cause too much diuresis, leading to dehydration     and its side effects (e.g., low blood pressure). Our purpose is to investigate what the     effects of furosemide are in the setting of brain surgery for tumors, specifically with     regards to decreasing brain bulk and/or causing dehydration.      Study Hypothesis: The addition of furosemide to mannitol will result in improved brain     relaxation in human subjects undergoing craniotomy for brain tumor resection than that seen     with mannitol alone. However, the combination of mannitol and furosemide will also lead to     more significant intravascular volume depletion than that seen with mannitol alone.   "
244122|NCT01054417|"     A diagnostic laparoscopy is frequently used to confirm the diagnosis of appendicitis.     However, laparoscopic criteria for determining appendicitis are not defined. If there is any     doubt about the presence of an abnormal appendix, it is usually removed. However, an     appendectomy of a negative appendix has a certain morbidity and for that reason it should be     avoided. The purpose of this study is to establish laparoscopic criteria for the diagnosis     appendicitis during diagnostic laparoscopy.   "
244123|NCT01054430|"     The objective of this study is to assess the single dose pharmacokinetics of avanafil in     subjects with hepatic impairment and in healthy control subjects.   "
244125|NCT01054456|"     This study is designed to assess the safety and efficacy of palonesetron in preventing CINV     (Chemotherapy-Induced Nausea and Vomiting) when administered to patients who have experienced     either vomiting and or at least moderate nausea during their last cycle of low emetogenic     chemotherapy.   "
244126|NCT01054469|"     Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in     patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP     block will result in a significant reduction in pain scores and morphine requirements in the     active group.   "
244127|NCT01054482|"     This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy     in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal     induction strategy.   "
244128|NCT01054495|"     Placebo control in acupuncture research is challenging and difficult. The primary objective     of the study is to explore a study design comparing stimulation by real acupuncture needle,     sham acupuncture needle and laser. The research question is whether a patient is capable of     discriminate different stimulation modality when studying acupuncture stimulation for nausea     in early pregnancy. The study is planned as a pilot study including 20 women in each of the     three study groups, all-together 60 pregnant women. Intervention will consist of standardised     15 minutes stimulation of acupuncture point pericardium 6 by, either two acupuncture needles,     two sham acupuncture needle or two laser devices. All participating women are told that they     will get different stimulation at an acupuncture point with potential effect on nausea. The     women will record their daily symptoms during a 4 day run-in period, a 3 day intervention     period, and thereafter a 4 day follow-up period after treatment in accordance with previous     research methodology. In addition, the women will record how they experience the three     different stimulations of acupuncture points. The results from the study could be important     for planning of future studies where the blinding issue with regard to acupuncture is     challenged.   "
244129|NCT01054508|"     Cardiovascular disease (CVD) is associated with high levels of low-density lipoprotein (LDL)     cholesterol and low levels of high-density lipoprotein (HDL) cholesterol.      CVD results from 'hardening of the arteries' when there is a build-up of cholesterol in the     walls of blood vessels. LDL is the main carrier of cholesterol in the body. LDL particles are     responsible for transporting cholesterol that is deposited in vessel walls. LDL particles can     also be altered in structure and turn into an irritant to the vessel walls. The body responds     to the irritating effect of LDL by producing substances that result in inflammation. This     sequence of events eventually leads to the vessels becoming permanently damaged. HDL has a     protective role in CVD. It is associated with the enzyme paraoxonase which protects the body     from the damaging effects of altered LDL particles.      Nicotinic acid (niacin) has the ability to lower LDL levels and raise HDL levels thus     reducing the incidence of CVD. Our study aims to show that niacin not only has good effects     on cholesterol levels but is also able to reduce inflammation. Niacin is often poorly     tolerated due to flushing side effect. Tredaptive is a formulation that combines niacin with     laropiprant, an agent that reduces flushing hence improving tolerability and compliance.      Patients who are receiving cholesterol-lowering medication and whose LDL levels have not     reached the recommended target are recruited to the study. The study will be conducted at the     Manchester Royal Infirmary. The study has two consecutive 16 week periods. In each period     patients will be randomised to either tredaptive or placebo. They will attend for 5     monitoring visits. Apart from the first visit, fasting blood samples will be taken from them     during all subsequent visits.   "
244130|NCT01054521|"     Currently, there are several alternative treatments for patients with chronic rhinitis (CR)     who failed medication. Although, most of the researches have been focusing on     temperature-controlled RF (TCRF), the cost is a major limitation for applying it worldwide.     The investigators objective of this study is to compare the subjective and objective outcomes     of Bipolar RF (BRF) with the more popular TCRF for CR treatment. The investigators     hypothesized that both have equivalent outcomes but with less operative time and potentially     at lower cost.   "
244131|NCT01054534|"     Determine the ability of real-time ultrasound with fusion technology of prior acquired MRI of     the pelvis to guide a needle to the second sacral foramen using the posterior approach and     place a interstim lead.   "
244132|NCT01054547|"     This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated     ropivacaine formulations.   "
244135|NCT01054586|"     APV10017 was a pharmacokinetic study that evaluated the pharmacokinetics, safety and     tolerability of fosamprenavir/ritonavir (FPV/RTV) at reduced doses over 14 days in     HIV-infected subjects with mild to moderate hepatic impairment (HI). Based on these data, two     new regimens have recently been approved by the EMEA and FDA in these patient groups; FPV     700mg BID/RTV 100mg QD for those with mild HI (Child-Pugh score 4-6) and FPV 450mg BID/RTV     100mg QD for those with moderate HI (Child Pugh score 7-9). The Committee for Medicinal     Products for Human Use (CHMP) has requested longer-term safety data among this hepatically     impaired HIV-infected population who have received the recently updated FPV/RTV dosing     regimens.      An observational cohort study will be conducted using routinely collected data in three     European HIV patient cohorts with a high proportion of hepatitis co-infected individuals.     Patients who received FPV/RTV will be followed to address the following objectives.      Primary: To assess the safety and tolerability of FPV/RTV-based ART in subjects with mild to     moderate hepatic impairment.      Secondary: A). To compare the safety and tolerability of FPV/RTV-based ART in subjects with     mild to moderate hepatic impairment when compared to FPV/RTV-based ART in hepatitis B (HBV)     or hepatitis C (HCV) co-infected subjects with normal hepatic function. B). To compare the     safety and tolerability of FPV/RTV-based ART to lopinavir/ritonavir LPV/RTV-based ART in     subjects with mild to moderate hepatic impairment.   "
244148|NCT01054768|"     The purpose of this study is to determine whether alpha-lipoic acid and acetyl-L-carnitine     will lower systemic inflammation in patients with Sickle Cell Disease by reducing oxidative     stress, which will result in a decrease in the frequency of vaso-occlusive pain episodes and     improve their quality of life.   "
244149|NCT01054781|"     The purpose of this study is to evaluate the complete response (CR) rate after Intensified     1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL   "
244185|NCT01055249|"     Single centre, subject and observer blinded, placebo controlled, cross-over study of the     effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR)     induced pain and inflammation in healthy volunteers conducted in two segments and using an     intra-individual comparison of application areas.   "
244490|NCT01049906|"     Hypothesis: When performed under ultrasound guidance, there is improvement in the sensory and     motor blockade obtained with stimulating popliteal catheters versus those placed without     nerve stimulation.   "
244136|NCT01054599|"     Many patients with epilepsy have memory deficits in the setting of otherwise normal     intelligence. Unfortunately, the treatment options for memory dysfunction in patients with     epilepsy are limited. The investigators are conducting a study to evaluate the effects of     memantine for the treatment of verbal memory dysfunction in subjects with     localization-related seizures. The study involves randomization to memantine therapy or     placebo, with cognitive testing and EEG pre- and post-treatment, as well as after an     open-label memantine treatment phase.      The primary aim of this study is to evaluate the efficacy of memantine for the treatment of     verbal memory dysfunction in subjects with left temporal lobe epilepsy. The investigators     expect that verbal memory task performance will improve in those taking memantine, but not in     those taking a placebo.      The investigators propose that the expected benefit of memantine is specific to verbal memory     in subjects with left temporal lobe seizures, rather than representing an overall improvement     in cognitive function. The investigators expect no improvement on other cognitive tasks in     either the memantine or placebo groups.      The investigators will evaluate whether subjects with left temporal lobe epilepsy and memory     difficulties have self-reported improvement in memory while taking memantine. The     investigators expect improvement of self-rated memory function on the Quality of Life in     Epilepsy Patient Inventory (QOLIE-89) in the memantine group, but no change on this scale in     the placebo group.   "
244137|NCT01054612|"     Currently there is no technique to produce thin (0.004-0.01 mm) serial sections of large     fresh tissue specimens that are suitable for high-resolution in situ protein/gene expression     studies without ice artifact or fixation-induced molecular damage. Traditional frozen     sectioning preserves protein and nucleic acid structure, but the inherent ice artifact     precludes reconstruction of protein and mRNA expression patterns in 3-dimensions. Since the     limitations of the existing sectioning techniques result from the fact that they rely on     mechanical cutting which in turn require the tissue to be stiff, we suggest a new approach to     cut tissue via an electro erosion process that utilizes focus radio frequency (RF).   "
244138|NCT01054625|"     This study is to support current and future Zalutumumab studies by increasing the     Pharmacokinetic (PK) knowledge of the drug. PK is the study of how a drug is absorbed (taken     up), distributed (moved around), metabolised (broken down) and excreted (removed) by the     body, in relation to time. The first PK trial only went up to 8 mg/kg, and, as there has been     some indication that the PK profile for the higher and lower doses is different, this needs     to be further evaluated. Furthermore, there is a need for more PK data on dosing with     16mg/kg.      The aim with this study is therefore to evaluate the PK profiles at different doses of     Zalutumumab and the amount of drug in the blood at different time points after single and     multiple doses. The results of this study, combined with data from completed and ongoing     Zalutumumab studies, will enable us to provide patients with an effective treatment option     which may significantly prolong their survival and/or improve their quality of life.   "
244139|NCT01054638|"     Cardiovascular disease (CVD) has been associated with HIV infection. However, it is uncertain     whether increased CVD rates are associated with HIV-related factors (e.g., HIV-infection or     highly active antiretroviral therapy (HAART) may worsen dyslipidemia) or reflect differences     in the prevalence of underlying risk factors for CVD. Furthermore, the association between     initiation and duration of HAART exposure and CVD risk, including which specific drugs within     the HAART classes may contribute to the increased risk, is unknown. The primary objectives of     the study are therefore:      1. To estimate the absolute and relative incidence rate (IR) of CVD claims-based diagnoses     among a cohort of adult patients from a large managed care population with a claims diagnosis     of HIV, AIDS, or AIDS-related complex (ARC) during periods of exposure to:        -  Any HAART compared to no HAART exposure        -  HAART class [i.e., NRTIs, NNRTIs, PIs, and Other (i.e., fusion inhibitors)] compared to          no HAART class exposure        -  Specific NRTI medications compared to no specific NRTI exposure   "
244140|NCT01054651|"     The purpose of this study is to determine the comparative efficacy of artesunate plus     sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children     infected with S.mansoni in western Kenya.   "
244141|NCT01054664|"     To assess the incidence of occult hepatitis C virus in hemodialysed patients with mild     impairment of liver enzymes   "
244142|NCT01054677|"     Main aim and objective      The aim was to present the treatment of infectious diseases in elderly, especially in nursing     homes and further to evaluate the effect of an intervention package aiming at improving     treatment with antibiotics in Swedish nursing homes      Specific objectives        -  Present the treatment patterns regarding infectious diseases, including gender aspects          in elderly, especially in nursing homes.        -  Through focus group discussions elucidate the decision making process in nursing homes          and target the intervention.        -  Based on the above information develop an educational intervention to contribute to the          improvement of the prescribing of antibiotics in nursing homes        -  Evaluate the effect of the intervention on quality of prescribing, knowledge and          attitudes in relation to available guidelines   "
244146|NCT01054729|"     Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100     mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B     status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg     active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in     order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day     0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study     which continued for 48 weeks. Participants were evaluated for sustained virologic response     (SVR) for an additional 24 weeks following completion of study treatment.   "
244147|NCT01054742|"     The purpose of this observational study was to provide summary data from participants who     relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care     PegIntron plus ribavirin in Part 1 of the study (NCT00709228) and who then received     retreatment during Part 2 of the study. Relapse was defined as having a positive virology     result at the Week 24 post-treatment follow-up, after a negative result at the Week 24     end-of-treatment time point. Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels were     measured at Day 1 and Weeks 12, 24, and 48 of the extension, and at Follow-up Week 24.   "
244227|NCT01046162|"     The purpose of this study is to compare bioavailability between formulations of alprazolam in     tablets to determine their bioequivalence in terms of rate and magnitude of absorption.   "
244150|NCT01054794|"     This is a prospective study of temporary gastric mucosal electrical stimulation (tGES) in 30     patients with gastroparesis (GP). After a 7 day baseline assessment of symptoms, subjects     will have an endoscopically-placed tGES lead implanted into the mucosa of the antrum. This     lead is connected to a thin wire that runs up the esophagus and out the nostril, similar to a     nasojejunal feeding tube, although much thinner. It is then attached to a programmable     battery pack which provides the desired level of stimulation.      Patients will then be randomized to 7 days OFF or 7 days ON stimulation in a double-blind     fashion. After 7 days, subjects will crossover to the other study arm (ie ON patients will be     switched off; OFF patients will be switched on). Symptoms and QoL measures will be assessed     at baseline, ON, and OFF periods. Serum ghrelin and other hormones, as well as EGG will be     assayed after 6 days in each arm.   "
244151|NCT01054807|"     The purpose of this investigation is to compare the fit characteristics and vision attributes     of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.   "
244152|NCT01054820|"     Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been     studied extensively in the setting of acute back strain. This study is being conducted as an     initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In     particular, this study is expected to provide information about the amount of improvement in     back strain among subjects using the FLECTOR Patch, which may then be used to inform     subsequent studies.   "
244153|NCT01054833|"     Urinary incontinence which is a major health issue in women affects 30-40% of older women.      Surgical treatments for SUI have undergone many modifications in the last century.      The Needleless Sling System is a one incision, minimally invasive, surgical procedure that     has had great acceptance in Europe and has recently received FDA Clearance for use in the     United States.      We will evaluate effectiveness and patient reported outcomes for Needleless® sling system     (Neomedic International).      This is a prospective, multicenter, registry. Up to 150 women will be enrolled from up to 3     registry sites.      Patients will be evaluated at baseline, peri-operatively, and post-operatively up to 2     months, up to 6 months and at 12 months.      Effectiveness evaluations will include a standing stress test (objective cure), SANDVIK     questions (subjective cure) & I-QOL (quality of life measure).      Other evaluations will include type of anesthesia, concurrent surgery, operative time,     post-operative pain, length of hospital stay, returning to usual activities, change of lower     urinary tract symptoms (BFLUTSSF, voiding diaries), goal achievement and patient     satisfaction.   "
244154|NCT01054846|"     -  To test the hypothesis if provision of helmet education and free helmet distribution          will significantly increase helmet use in preschool children of low-income families          compared to those children receiving helmet education without free helmet distribution;        -  To test the hypothesis if helmet users in preschool children will significantly reduce          head and facial injuries compared to those non-helmet users   "
244155|NCT01054859|"     The purpose of this study is primarily to evaluate whether taking avanafil with alcohol     causes the blood pressure to fall.   "
244156|NCT01054872|"     The purpose of this study is to examine the role of genetics in determining the immune     response to an HIV vaccine in pairs of HIV-uninfected twins.   "
244157|NCT01054885|"     The Purpose of this study is to assess the efficacy and safety of two strengths of the     FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)   "
244158|NCT01054898|"     The purpose of this study is to determine if a telephone social support and empowerment     intervention is more effective than usual community services in improving the mental health     of community-dwelling women abused by their intimate partners.   "
244159|NCT01054911|"     The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor     removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage     allowing for successful surgery. Therapy will be administered orally and the response of the     tumor will be assessed using CTs or MRIs.   "
244160|NCT01054924|"     The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the     Invendo C20 Colonoscopy System   "
244161|NCT01054937|"     The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single     dose administration in healthy volunteers.   "
244162|NCT01054950|"     Food allergies are becoming more prevalent with more children being diagnosed with food     allergies each year. Food allergies place a tremendous burden not just on the patient but on     his/her family as well. In an attempt to provide better care to the investigators patients,     the investigators would like to determine if regular contact with our food allergy nurse has     a positive effect on a family's perceived quality of life.   "
244163|NCT01054963|"     Inflammatory arthritis (IA) is a major cause of long-term disability. Peer support may be a     solution to the common problem of delayed treatment. Early peer support may result in     improved use of therapy, higher self-efficacy, reduced anxiety, and improved coping in the     first two years post-diagnosis. This study involves the development and testing of a peer     mentor training initiative as one part of an intervention study for people with early IA     (EIA). Peer mentors will be trained and assessed to provide one-on-one support (information,     emotional, feedback) to individuals who have recently been diagnosed with IA. This is one     part of an intervention study. The other part is called Peer to Peer Mentoring: Facilitating     Individuals with Early Inflammatory Arthritis to Manage their Arthritis - Peer Mentoring     Program.   "
244164|NCT01054976|"     This study will examine whether the administration of galantamine is effective for     improvement of attention and more effective for patients with serious disturbance of     attention by administering galantamine to patients with Alzheimer's dementia and performing     an attention test on baseline, week 4 and 12.   "
244165|NCT01054989|"     The combination of impaired insulin sensitivity and insulin secretion is thought to be the     basis of type 2 diabetes. Increased free fatty acids levels impair insulin action in muscle     and liver, but also systemic inflammation processes play a role in the development of insulin     resistance.      This study compares the effects of fat and inflammation on insulin sensitivity, systemic     inflammation, energy metabolism, vascular system and neural function in healthy humans.   "
244239|NCT01046318|"     The purpose of this clinical study is to evaluate the safety and efficacy of OPC-262 5 mg in     patients with type 2 diabetes by repeated administration orally for 52 weeks.   "
244166|NCT01055002|"     This is a pilot study of a protocol for inducing a falciparum malaria infection in healthy     volunteers in order to test the activity of novel agents being developed as drugs for the     treatment of uncomplicated malaria. In this pilot study, 16 healthy male volunteers will be     administered a low level malaria infection via infected human red blood cells. After 6 days     they will be administered one of two registered antimalarial treatments (8 volunteers for     each treatment) in order to define the rate of clearance of the infection. This information     will be used to design similar future studies for the initial assessment of the efficacy of     novel antimalarial drugs in development.   "
244167|NCT01055015|"     This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients     who have undergone primary unilateral total knee arthroplasty   "
244168|NCT01055028|"     This is an open-label, single-arm, multi-center, Phase 2 study with Paclitaxel in combination     with Bevacizumab in patients with Unresectable or Metastatic Angiosarcoma. The study aims to     determine the safety and effectiveness of combining two drugs Paclitaxel and Bevacizumab in     the treatment of Angiosarcoma that cannot be removed by surgery, or has spread to other parts     of your body. The primary objective is to evaluate 4month non progression rate. The secondary     objective is to evaluate overall response rate after 3rd and 6th cycle, median duration of     response, 6th and 12th month survival, toxicity of Paclitaxel and Bevacizumab combination,     toxicity of maintenance Bevacizumab and to collect paraffin-embedded tumor blocks for     angiogenesis markers and tissue microarray.   "
244169|NCT01055041|"     The purpose of this study is to know the effect of another controller medication add on to     the inhaled corticosteroid and long acting β2 agonist on clinical symptom, lung function and     compliance in patients of moderate to severe persistent bronchial asthma.   "
244170|NCT01055054|"     Periodic analyses of our extensive database with regards to different surgical procedures for     severe obesity and different obesity co-morbidities will be of benefit to our severely obese     patients as well as to others world-wide.   "
244171|NCT01055067|"     This is a multicenter, single-arm study for safety and efficacy.   "
244172|NCT01055080|"     The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or     essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk     based formula is effective in the prevention of type 1 diabetes associated beta-cell     autoimmunity in children at genetic risk of type 1 diabetes.   "
244173|NCT01055093|"     The aim of the prospective observational GDC-Study in patients with newly diagnosed diabetes     mellitus aged 18-69 years at inclusion into the study is to characterize in detail the     clinical, metabolical and immunological phenotype and monitor the progression of the disease.   "
244174|NCT01055106|"     The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3     regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.   "
244175|NCT01055119|"     The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects     behavior and cognition in children with attention deficit hyperactivity disorder.   "
244176|NCT01055132|"     The purpose of this study is to determine the relative performance of a new daily disposable     toric soft contact lens against a daily disposable toric contact lens currently available in     market, specifically with regards to the comfort and vision with the lens.   "
244177|NCT01055145|"     Fluoroquinolone is a one of the most important drugs for treatment of multidrug-resistant TB     (MDR-TB). Among them, levofloxacin and moxifloxacin has been used most widely. However, there     is no study to directly compare the efficacy of levofloxacin and moxifloxacin among MDR-TB     patients. The investigators will compare the efficacy of levofloxacin and moxifloxacin     through a prospective multicenter randomized open label phase III trial.   "
244178|NCT01055158|"     The purpose of this study is to evaluate the effectiveness of a telephone-based, cognitive     behavioral therapy intervention in the treatment of depression in adults diagnosed with HIV.   "
244179|NCT01055171|"     The purpose of this study is to examine the effect of propranolol versus placebo on craving,     distress and cue reactivity to trauma and alcohol cues.   "
244180|NCT01055184|"     Unlike most influenza viruses, the 2009 H1N1 virus has affected people between 5 and 40 years     old more often than people 60 years old or older. It may be that older people have had     greater exposure to previous strains of H1N1 influenza, and this previous exposure protects     them from infection. This study will examine how older people respond to a version of the     H1N1 virus vaccine that includes a live, noninfectious version of the virus.   "
244181|NCT01055197|"     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an     effective treatment for extensive stage small cell lung cancer.      PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain     works when given with or without radiation therapy to other areas of the body in treating     patients with extensive stage small cell lung cancer.   "
244183|NCT01055223|"     Treatment with thiazolidinediones (TZD) has recently been reported to possibly increase the     risk of fractures in a randomized trial exploring the efficacy of rosiglitazone (RSG),     metformin, or glyburide encompassing 4360 patients with type 2 diabetes.      It is hypothesized that spironolactone, a diuretic that is broadly used for the treatment of     fluid retention and edema associated with TZD, has a potential protective effect against bone     fractures. However, to our knowledge, this has not been tested in diabetic patients treated     with TZD. Amiloride is another diuretic that shares with spironolactone the anti     mineralocorticoid ion gated channels activity and will be analysed in this study with regard     to possible protective effect against bone fracture in combination with TZD.      This study is a nested case-control study conducted among type 2 diabetes subjects exposed to     TZD. The study aims to explore if the risk of fracture is reduced among type 2 diabetic     subjects exposed to spironolactone and TZD. The study will compare the odds of any low impact     fracture, and hand, foot, upper arm, wrist, and hip fracture incidence in subjects treated     with TZD+spironolactone and TZD+amiloride compared to subjects treated with TZD only.      The study population will consist of type 2 diabetes patients aged 18 -65 years old exposed     to TZD. To be eligible for the study, a subject must have had at least one International     Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months or at     least 12 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO] or troglitazone)     during their follow-up time available in the database.   "
244186|NCT01055262|"     The objectives of this study are to evaluate the dermal safety and on-body temperature of a     disposable heatwrap product when worn while in a supine position for five consecutive days.     The product will be worn on the back for approximately 8 hours per 24 hour period.   "
244187|NCT01055275|"     The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician     experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and     performance.   "
244188|NCT01055301|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Biological therapies, such as thalidomide and lenalidomide, may     stimulate the immune system in different ways and stop cancer cells from growing. Drugs used     in chemotherapy, such as dexamethasone, cisplatin, doxorubicin hydrochloride,     cyclophosphamide, etoposide, and melphalan, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Combining     chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses     of chemotherapy drugs and kill more cancer cells. Giving bortezomib, thalidomide, and     combination chemotherapy before and after transplant and lenalidomide after transplant may be     an effective treatment for multiple myeloma.      PURPOSE: This phase II trial is studying how well giving bortezomib, thalidomide, and     lenalidomide together with combination chemotherapy and autologous stem cell transplant works     in treating patients with newly diagnosed multiple myeloma.   "
244189|NCT01055314|"     This randomized pilot clinical trial is studying the side effects and how well giving     temozolomide and cixutumumab together with combination chemotherapy works in treating     patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Giving     temozolomide and cixutumumab together with combination chemotherapy may kill more tumor     cells.   "
244190|NCT01055327|"     In 2007 a case control study was completed within the EUROCAT European network of congenital     anomaly registers to test the hypothesis that first trimester lamotrigine monotherapy     exposure is associated with an increased risk of isolated oral clefts. This study found no     statistically significant increased risk of oral clefts compared with other defects following     lamotrigine exposure in the uterus. The EUROCAT Antiepileptic Drug (AED) Database,     established for the original case control study in 2007, will now be expanded to include an     additional five to six years worth of data. These data will provide greater power to     investigate the risk of isolated oral clefts, specific cleft types and potential associations     with additional specific malformation types (e.g. neural tube defects). Data on cases of     isolated oral clefts registered between 1993 and 2012 will be extracted from EUROCAT member     registers meeting set inclusion criteria (ensuring completeness of outcome and exposure     data). The primary comparison group will include all non oral cleft, non chromosomal     malformations as the registers do not collect data on non malformed infants. This study will     also be powered to include a second control group of chromosomal malformations, very unlikely     to be associated with medication exposure. Data on exposure to anti-epileptic drugs (AEDs)     during the first trimester of pregnancy will be extracted along with other key covariates     including age of mother, history of epilepsy and gestational age of the infant. Primary     analyses, using logistic regression, will compare the lamotrigine monotherapy versus no AED     use across case and control groups and a secondary analysis will compare lamotrigine     monotherapy versus other AED monotherapy (with and without valproate). Data will also be     monitored for patterns of lamotrigine exposure across additional specific malformation groups     of interest.   "
244191|NCT01055340|"     This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral     or better than placebo in lowering ambient glucose levels during a graded glucose infusion     (GGI) and that a single dose of OXM will lead to a statistically significant increase in the     sum of the plasma βOHB + AcAc levels compared to placebo.   "
244192|NCT01055353|"     Evaluation of target organs damage in hypertensive patients with no known cardiovascular (CV)     or renal disease, stratified according to level of blood pressure control   "
244193|NCT01055366|"     The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from     prior pharmacotherapy in patients with open-angled glaucoma.   "
244194|NCT01055379|"     The primary endpoint for this study is the clinical response after 12 weeks of treatment,     defined as a change in total score from baseline depressive symptoms as measured by the Beck     Depression Inventory-Amended (BDI-IA) total score.   "
244223|NCT01046110|"     This trial will be conducted in Africa, Asia, North America and South America. The aim of     this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to     subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes     inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).   "
244195|NCT01055392|"     Lithium salts have been used for the treatment of psychiatric disorders for over five     decades, mostly as a mood-stabilizing drug. Recent evidence points to the inhibition of the     enzyme glycogen synthase kinase-3beta (GSK3) as one of its mechanisms of action. The     overactivity of this enzyme has been implicated in the pathogenesis of Alzheimer's disease     (AD), given its involvement in mechanisms related to the hyperphosphorylation of Tau protein     and the production of beta-amyloid peptide. These are key events leading respectively to the     formation of neurofibrillary tangles and senile plaques, which are the neuropathological     hallmarks of the disease. Several in vitro and animal studies have shown that the inhibition     of GSK3 by lithium and other agents attenuates these pathological processes, reinforcing the     notion that GSK3 is a likely target for future disease-modifying therapies for AD. Indeed, a     recent study published by our group showed that chronic lithium use is associated with a     decrement in the expected prevalence of dementia, in a sample of elderly individuals with     bipolar disorder. To investigate this putative neuroprotective effect in a prospective way,     the investigators started 24-month randomized, double-blinded controlled trial of lithium for     the prevention of dementia in a sample of elderly individuals with amnestic mild cognitive     impairment (MCI), a condition associated with increased risk for the development of AD. The     clinical and biological outcomes of this trial include the attenuation of cognitive deficits,     and the modification of certain biological markers of the disease (as measured in the     cerebrospinal fluid, leukocytes and platelets). The objective of the present application is     to enable the extension of this ongoing trial to an additional 2-year follow-up. A longer     follow-up (48 months) will increase the statistical power to ascertain the primary outcome     variables of this study, particularly the con-version from MCI to Alzheimer's disease. This     will warrant a more consistent conclusion about the potential of lithium treatment in the     prevention of dementia, in addition to a better evaluation of safety and tolerability     profiles of the long-term use of lithium in older individuals.   "
244196|NCT01055405|"     Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of     pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric     oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries     of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary     disease (COPD), the investigators hypothesized that sildenafil might improve pulmonary     hemodynamics and increase exercise tolerance in this condition.   "
244491|NCT01049919|"     This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA)     to prevent or delay major amputation and/or death in subjects with critical limb ischemia     (CLI) due to severe peripheral arterial disease (PAD).   "
244197|NCT01055418|"     This investigation is interested in the effects of high dose vitamin C on endothelial     function in healthy humans. A high fat meal will be utilized to induce endothelial     dysfunction. It is hypothesized that, via antioxidant actions, vitamin C will reverse these     effects and in turn improve blood flow- the involvement of nitric oxide suggests that this     could extend to cerebral blood flow. This will be monitored by trans cranial doppler flow     meter and near infrared spectroscopy.   "
244198|NCT01055431|"     It has been estimated that 1 in 2 women expecting a baby will be diagnosed with iron     deficiency. In turn iron deficiency can affect the health and wellbeing or both mother and     child. Studies show that low iron stores prior to conception and low iron intakes during     pregnancy may both be contributing to this problem. Although dietary supplements may be one     solution, research indicates that daily compliance is low (Nguyen et al., 2008). Furthermore,     prescribed iron supplements may result in uncomfortable side-effects, including constipation     (Wulff & Ekstrom, 2003).      It is been observed in Ethiopia that iron deficiency anemia is lower than average; a finding     that has been attributed to regular Teff consumption (Gies et al., 2003). Teff (Eragrostis     tef) is a staple food usually consumed in the form of Enjera (flat bread prepared using a     range of cereals). Research has shown that Teff is a rich source of iron that is easily     absorbed by the body.      Although it is believed that regular Teff consumption may prevent to onset of iron deficiency     anemia there is no research to support this. Therefore, the aim of the present study is to     es-tablish whether incorporating Teff into the daily diet may be one way to improve blood     profile and prevent the onset of iron deficiency anemia in expectant mothers. Study findings     will demonstrate whether Teff may be an alternative source of iron that can be easily     incorporated into the daily diet of both pregnant mothers and the lay public.   "
244199|NCT01055444|"     The purpose of the study is to explore the potential usefulness of a heated lidocaine 70     mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder     impingement syndrome   "
244200|NCT01055457|"     This study compares an investigational contact lens care multi-purpose solution to a     currently marketed multi-purpose solution.   "
244201|NCT01055470|"     The purpose of this study was to compare the pain relieving action of the lornoxicam and     diclofenac in patients of OA knee.   "
244202|NCT01055483|"     The study will determine the maximal tolerated dose (MTD) of panobinostat administered in     combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients     with relapsed or refractory acute myeloid leukemia (AML).   "
244203|NCT01055496|"     This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in     combination with inotuzumab ozogamicin, an investigational product, in adults with     CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects     will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and     prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine,     cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab     ozogamicin.   "
244204|NCT01055509|"     The purpose of this study is to determine whether Cognitive Adaptation Training are effective     in comparison with conventional treatment, focusing on social functions, symptoms, relapse,     re-hospitalisation, and quality of life in outpatients with schizophrenia.   "
244205|NCT01055522|"     This Phase II clinical study is an open-label, multicenter study of L19IL2 in combination     with Dacarbazine in patients with metastatic melanoma.      The study is divided in two parts: a phase IIa part, designed to establish the recommended     dose (RD) of L19IL2 when administered in combination with a fixed dose of Dacarbazine, as     well as to determine the preliminary tolerability profile; the second phase IIb part     evaluates the objective response rate (ORR) including a randomized study with a fixed dose of     Dacarbazine with or without L19IL2, dosed at the RD determined in phase IIa.   "
244206|NCT01055535|"     This study will evaluate the safety and efficacy of Microplasmin administered as an     intravitreal injection, in subjects with focal vitreomacular adhesion. Ultimately, it is     believed that intravitreal microplasmin may offer physicians a safe agent for pharmacologic     vitreolysis and induction of Posterior Vitreous Detachment (PVD) without the need for     vitrectomy. This clinical study is justified because the study sponsor believes the potential     benefits outweigh the potential risks, as outlined below.   "
244207|NCT01055548|"     The aim of the pilot study is to explore and identify the issues of concern to parents whose     babies have been cared for in a neonatal unit and exposed to imaging, its influence on     diagnosis and information-giving process   "
244209|NCT01055574|"     The purpose of this study is to compare the physical capability outcomes of patients who     undergo single-level ProDisc-L disc replacement with those of patients who undergo     stand-alone, single-level anterior lumbar interbody fusion (ALIF). This study will be the     first multi-center clinical study to use clearly measurable outcomes from physical tests to     compare the results of lumbar disc arthroplasty with disc fusion.   "
244210|NCT01055587|"     This study was designed to investigate, if new biomarkers may improve the early diagnostic of     infections following major abdominal surgery and severe burn injuries.   "
244211|NCT01055600|"     This is a Phase IV study to evaluate eltrombopag concentrations in breast milk of nursing     mothers taking marketed eltrombopag (PROMACTA®). Up to 10 subjects (mother-infant pairs) at     as many as 10 study centers in the US will be enrolled. Nursing mothers who are registered     with the PROMACTA Pregnancy Registry will be offered the option to participate in this trial     if they continue to take commercial eltrombopag post-delivery and decide to breastfeed their     infant. Information will be collected in a diary. Breast milk samples will be collected     before and after infant feedings for a 24 hour period after eltrombopag dosing to evaluate     the eltrombopag concentrations in the breast milk. Mothers will also be given the option to     have a pharmacokinetic (PK) blood sample collected from the infant.   "
244212|NCT01055613|"     This study compares an investigational contact lens care multi-purpose solution to a     currently marketed multi-purpose solution.   "
244281|NCT01046877|"     The objective of the study is to evaluate the safety and efficacy of the Acclarent     Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in     patients indicated for such treatment for chronic otitis media with effusion (OME) or     recurrent acute otitis media (AOM).   "
244213|NCT01055626|"     Obesity is a serious medical problem because it increases the risk of cardiovascular disease     (CVD), type 2 diabetes mellitus, and certain forms of cancer. The definition of obesity is     based on an excess of body fat, not of BMI. However, BMI is the reference used to establish a     graded classification of weight relative to height. Although BMI is widely used as a simple     surrogate measure of body fat and has been shown to correlate closely with adiposity, it     would be more appropriate to determine body fat percentage and to use this value for     classification purposes. The present study contemplates the determination of the per cent     body fat with the aim of establishing new diagnostic and therapeutic criteria according to     the associated comorbidities.   "
244214|NCT01055639|"     The purpose of the study is to test a brief, individual psychosocial in-person or telehealth     intervention to reduce interference of pain with daily life, emotional distress, and pain     intensity, and improve quality of life and physical activity levels in individuals with     chronic pain.   "
244215|NCT01055652|"     The purpose of this study is to evaluate the pharmacokinetics of dapagliflozin when     administered alone or in combination with voglibose in Japanese patients with type 2 diabetes     by assessment of AUC and Cmax of dapagliflozin   "
244216|NCT01046019|"     Research with DXA has shown the pattern of bone remodelling around an implant. The baseline     and reference value for such calculations is the first measurement after the operation. The     baseline measurement is performed at different time from study to study. If there is a rapid     bone loss the first weeks after an operation, this will influence the reference value and     then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA     measurements within the first 2 weeks. Our hypothesis is that there is a rapid bone loss the     first 2 weeks after operation and that timing of the first post operative measurement will     influence the later results.   "
244217|NCT01046032|"     The aim of study was to investigate whether pre-treatment with metformin before and during     IVF increases the live birth rate compared to placebo in women with sonographic evidence of     polycystic ovaries (PCO), but without any clinical manifestations of polycystic ovary     syndrome (PCOS).   "
244218|NCT01046045|"     Despite the remarkable improvement in short-term patient and graft survival among the     recipients of kidney transplants, the progressive renal dysfunction (chronic allograft     dysfunction) accompanied by chronic interstitial fibrosis, tubular atrophy, vascular     occlusive changes and glomerulosclerosis remains the chief cause of graft loss. As a result     of this damage from immunologic and non-immunologic injury, the long-term survival of kidney     transplants has changed little during the past decade. And, among the non-immunologic     factors, calcineurin inhibitor nephrotoxicity has been shown to be the most common factor     leading to long-term graft damage and progression to graft failure. This is further supported     by the previous finding that long-term use of calcineurin inhibitor-based therapy leads to     deterioration in kidney function, even in recipients of non-renal organ transplants.      The growing interest in calcineurin inhibitor minimisation protocols to optimize renal     transplant outcome offers a new therapeutic options in the management of patients with     chronic allograft dysfunction. Recently, mammalian target-of-rapamycin inhibitors (mTOR     inhibitors) including everolimus has been shown to achieve an improvement of long-term     function through an early modulation of immunosuppressive regimen. In this aspect,     percutaneous renal graft biopsy represents an important diagnostic tool to allow     visualization of the lesions of chronic allograft dysfunction and therefore the ability to     delineate the potential improvement after introduction of everolimus. Histologic and     morphometric findings from a protocol-mandated biopsies obtained from renal transplant     recipients who are suffering from chronic allograft dysfunction and treated with everolimus     are needed to provide a clinical blueprint for the drug's efficacy, if confirmed.   "
244219|NCT01046058|"     The purpose of the study is to investigate the effect of moderate and severe hepatic     impairment on the pharmacokinetics of TMC435. Pharmacokinetics means how the drug is absorbed     into the bloodstream, distributed in the body and eliminated from the body. In addition, the     short-term safety and tolerability of TMC435 in participants with hepatic impairment will be     determined. The results of this study will guide dose recommendations for TMC435 in patients     with impaired liver function.   "
244220|NCT01046071|"     The purpose of this study is to determine whether Transversus abdominis plane block as part     of a multimodal postoperative regimen is superior to control in analgesic efficacy after     laparoscopic cholecystectomy.   "
244221|NCT01046084|"     The object of this study is to compare the relative bioavailability of lansoprazole 30 mg     delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and     distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP     Pharmaceuticals, Inc.) in healthy, adult, subjects under non-fasting conditions.   "
244222|NCT01046097|"     The purpose of this post-marketing surveillance study is to evaluate the safety of Synflorix™     when administered according to the local Prescribing Information to healthy Filipino infants.   "
244224|NCT01046123|"     Radiotherapy to the whole brain is standard treatment for cancer that has spread to the brain     (brain metastases) as it treats both the metastases that can be seen on scans and the brain     metastases that are too small to be seen on scans.      This study will use a novel radiotherapy technique, called volumetric modulated arc therapy     (VMAT), to treat patients with brain metastases. This technique allows delivery of both a     standard radiation dose to the whole brain as well as a higher radiation dose to the brain     metastases at the same time.      The study will assess the effectiveness of using VMAT in treating brain metastases, and     examine its potential side-effects.   "
244225|NCT01046136|"     This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex     in patients with colds. Patients will receive 7 days of treatment with either Mucinex or     placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.   "
244226|NCT01046149|"     The specific aims of this study are:        1. To develop a breathing training protocol specifically designed to improve HRV and          psychosocial functioning for postmenopausal women with depressive symptoms,        2. To examine the immediate effects of an 8-week breathing training program on HRV and          psychosocial end points in postmenopausal women with depressive symptoms,        3. To examine the intermediate-term effects of an 8-week breathing training program on HRV          and psychosocial end points in postmenopausal women with depressive symptoms, and        4. To determine whether the change in depressive symptoms with breathing training in          postmenopausal women is associated with the change in HRV.   "
244228|NCT01046175|"     Respiratory complications continue to be one of the leading causes of morbidity and mortality     in people with spinal cord injury, especially among cervical and higher thoracic injuries.     Both inspiratory and expiratory function are often severely decreased, leading to respiratory     complications, such as atelectasis, pneumonia and ventilatory failure. The prevention of     these respiratory complications needs to begin immediately after injury. To achieve effective     expelling of secretions before they form mucus plugs, it is essential to improve patients     ability to cough. Manually assisting the cough is one way of increasing cough flow, but an     effective cough also requires adequate lung volumes. The emphasis should therefore be on     expansion of the lungs before coughing. One way of expanding the lungs is by air-stacking. In     air-stacking insufflations are stacked in the lungs to maximally expand them. Cough can be     valued by measuring Peak Cough Flow (PCF). By combining air-stacking with manually assisted     cough the PCF can be increased sufficiently. The aim of this study is to compare the effect     of two different air-stacking techniques on PCF, air-stacking on a respirator versus     air-stacking with a manual resuscitator.   "
244229|NCT01046188|"     The purpose of this study is to evaluate an interactive web-based teaching tool in IVF     patients. Patients will be randomized to participate in web-based IVF teaching or a didactic     lecture. A knowledge questionnaire will be completed both prior to and following the teaching     intervention. Both groups will also complete stress and satisfaction surveys throughout the     IVF treatment cycle. Groups will be compared at the completion of the study for demographics,     level of knowledge, stress and satisfaction. The web-based group will be evaluated for web     usage.   "
244230|NCT01046201|"     The Pediatric Obesity Research Registry will function to collect and catalog historical and     medical chart related clinical data of patients presenting with pediatric obesity and who     agree to participate.   "
244231|NCT01046214|"     The objective of this study is to evaluate the comparative bioavailability between bupropion     hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL®     300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients     under fasting conditions.   "
244232|NCT01046227|"     The patients of pediatric haemato-oncology have a higher risk for novel H1N1 influenza     infection than general population, and they are strongly recommended to receive novel H1N1     vaccination. However, there is no previous data to answer how the efficacy and effectiveness     of novel H1N1 vaccination is in patients of pediatric haemato-oncology. This study is     designed to investigate the antibodies titers before and after the novel H1N1 influenza     vaccination in these patients. Titer of H1N1 influenza virus antibodies will be determined by     hemagglutinin inhibition assay (HAI). A HAI titer with a 4-fold rise or greater is defined as     seroconversion. Study subjects with seroconversion are regarded as responsiveness to the     vaccination. Meanwhile, if the patient presents influenza-like symptoms, we will perform     throat swab or nasal swab for influenza rapid test, viral isolation, and novel H1N1 influenza     PCR to confirm the diagnosis. After the study, we will be able to know whether or not current     novel H1N1 influenza vaccination schedule is adequate and efficient for pediatric     haemato-oncology patients.   "
244233|NCT01046240|"     This trial compares the pharmacokinetics of palonosetron administered subcutaneously and     intravenously.   "
244234|NCT01046253|"     The object of this study is to compare the relative bioavailability of lansoprazole 30 mg     delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and     distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP     Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting conditions with dosing by     applesauce-sprinkle method.   "
244235|NCT01046266|"     This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as     compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will     receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study     treatment is up to 3 months, and target sample size is <50.   "
244236|NCT01046279|"     Prospective casecontrol study in glioma patients undergoing treatment with bevacizumab     (Avastin). At present there are no data on the correlation between occurrence of arterial     hypertension and clinical outcome in patients with glioma or anaplastic astrocytoma. We will     investigate whether glioma patients developing hypertension under bevacizumab treatment have     a better outcome in terms of progression free survival, response rate and overall survival     than equally treated patients remaining normotensive. Moreover, we will describe the dynamics     of change in blood pressure after administration of bevacizumab in those patients developing     hypertension.        -  Trial with medicinal product   "
248943|NCT01114750|"     A pharmacokinetic study on the absorption of perorally delivered insulin in dextran matrix     after single dose administration.   "
244237|NCT01046292|"     The aim of this study is to evaluate the effects of Ginkgo Biloba Extract (GBE) in executive     function-impaired Mild Cognitive Impairment (MCI) patients by assessing gait while walking     alone as well as under differing dual-task conditions.      The primary endpoint in the evaluation of GBE efficacy is gait speed. The secondary endpoint     is cycle time variability under dual-task conditions.   "
244238|NCT01046305|"     Objectives:      The objective of this study is to measure and delineate the symptom burden experienced by     patients with chronic myeloid leukemia (CML).      The Primary Aim is to develop and validate an M. D. Anderson Symptom Inventory (MDASI) module     (the MDASI-CML), compliant with FDA standards for patient-reported outcomes (PROs), to     measure the severity of multiple symptoms and the impact of these symptoms on daily     functioning in patients with CML.      The Secondary Aims are:        1. to develop a detailed description of the severity and interference with daily activities          of symptoms experienced by patients with CML;        2. to assess the impact of symptom severity in CML on standard functioning and quality of          life (QOL) measures including Eastern Cooperative Oncology Group (ECOG) Performance          Status and single-item QOL scale;        3. to evaluate the MDASI-CML as an estimate of functional status and QOL in patients with          CML;        4. to identify common clusters of symptoms and symptom patterns occurring over multiple          measurement time points in patients with CML;      5, to define the qualitative symptom burden of patients with CML;      6. to explore the feasibility of the Interactive Voice Response (IVR) system in measuring     symptom severity and interference with daily activities over time in patients with CML.   "
244240|NCT01046331|"     The demographic characteristics, clinical features, course, and outcomes of severe H1N1     influenza infection requiring intensive care have not been defined rigorously and     systematically. While the majority of patients in early reports of critically ill novel     influenza A (H1N1) have respiratory involvement, up to 10-20% may present with     non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden     of disease and resource utilization of these patients remains largely unknown. The purpose of     this surveillance registry is to characterize the demographics, clinical features, outcomes,     and resource utilization of patients with H1N1 influenza infection who require intensive     care.   "
244241|NCT01046357|"     This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single     ascending dose study in healthy male volunteers conducted at a single centre. The effect of     food on the pharmacokinetics of AZD7687 will also be studied.      The study will consist of two parts, a dose escalation part and a food interaction part. The     two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different     panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation.     Each subject will receive dose only once, except for the volunteers included in the dose     steps repeated for food interaction.   "
244242|NCT01046370|"     The purpose of this pilot study is to gather preliminary data on the efficacy and feasibility     of the Amygdala Retraining Program (ARP), a mind-body practice versus a control (C) on     fatigue, quality of life and sleep in patients with Chronic Fatigue Syndrome (CFS), Chronic     Fatigue (CF) and Fibromyalgia (FM).      CFS, CF and FM are incapacitating disorders characterized by profound fatigue, muscle pain,     impaired memory, insomnia, and post-exertional malaise (Fukuda 1994). Current literature     points to a centrally sensitized state in CFS, CF and FM (Meeus 2007). The ARP attempts to     retrain this neuronal network through mind-body practices such as cognitive restructuring via     neurolinguistic programming, yoga based breathing and simple mindfulness based meditation. A     case series of 33 patients with CFS and ARP reported improvement in 92% of patients with     two-thirds of patients reaching 80-100% of pre-illness levels of health (Gupta 2009). However     ARP has never been formally studied in CFS.      We propose to gather preliminary data on the efficacy and feasibility of ARP versus C on     fatigue, quality of life and sleep in 30 patients with CFS, CF and FM. All participants will     undergo standard clinical treatment which consist of a 2 day self-management program in the     Chronic Fatigue Clinic. Following this, participants will be randomized into the ARP or C     group. The ARP group will receive an additional 2.5 hour training surrounding core concepts     of the ARP program. They will then be given the ARP DVD program and booklet, to reinforce and     continue the practice. They will then receive scheduled bi-monthly phone calls for 3 months     from a study investigator for support. The C group will receive only standard care. However     they will receive a complementary copy of the ARP program at the end of the study (6 month     time point) as a gift for participation in the study.      Preliminary data on efficacy will be assessed at baseline, 1, 3 and 6 months using the     following validated questionnaires: Multidimensional Fatigue Inventory (MDFI), Short form-36     (SF36) Fibromyalgia Impact Questionnaire (FIQ), Epworth Sleep Scale (ESS) and Measure Your     Medical Outcome Profile (MYMOP-2). Feasibility will be assessed by evaluation of a daily     practice log where patients record the total time spent daily in the practice of ARP and any     specific difficulties they encountered in the practice of the program.   "
244243|NCT01046383|"     The primary aim of this IMN 1207 follow-up study is to confirm the effect of a cysteine-rich     non-denatured whey protein isolate formulation IMN1207 (20g daily) versus casein (20 g daily)     on the reversal of weight loss (cancer-related wasting) over a 40 week treatment period in     non-small cell lung cancer patients with or without conventional therapy, i.e., chemotherapy     or radiation. And to test the hypothesis that over a period of 66 weeks observation period     which includes a 6 months follow-up period, increases the survival of these patients.   "
244244|NCT01046396|"     The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1%     to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3)     weeks.   "
244245|NCT01046409|"     The purpose of this trial is        1. to compare the clinical significance of the main vessel and the side branch vessel using          EKG, pain score and coronary wedge pressure        2. to develop a new scoring system to predict the clinical significance of a side branch   "
244246|NCT01046422|"     The purpose of this study is to determine if BMS-770767 is safe, well tolerated, measure its     levels in the blood (pharmacokinetics), and measure the levels of chemicals (biomarkers) that     may be affected by this drug (pharmacodynamics) in a type 2 diabetes patient population   "
244247|NCT01046435|"     The purpose of this study is to determine if treating periodontal infections (gum disease)     will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases.   "
244257|NCT01046565|"     The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1%     to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3)     weeks.   "
244558|NCT01056549|"     Exenatide acutely inhibits intestinal lipoprotein particle production. We are unable to     speculate whether exenatide affects hepatic lipoprotein production in humans since there is     currently no evidence from animal models or in vitro studies that have demonstrated an effect   "
244248|NCT01046448|"     Children and adolescents with chronic kidney disease (CKD) are at high risk for     cardiovascular (CV) morbidity and mortality. Recent studies suggest that pediatric patients     with even moderately impaired kidney function may be afflicted with significant early cardiac     and vascular abnormalities.      The pathogenesis and the natural course of CV comorbidity in pediatric CKD patients is still     elusive. In this multicenter, prospective, observational study the prevalence, degree and     progression of CV comorbidity in children will be characterized and related to CKD     progression. The morphology and function of the heart and vessels will be monitored by     sensitive, non-invasive methods and will be compared with aged matched healthy controls.     Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors     will be monitored prospectively and will be related to CV status. Genotyping might identify     predisposing genetic factors for progression of CV comorbidity and underlying nephropathies.   "
244267|NCT01046695|"     We propose to evaluate the use of Transcutaneous Electrical Nerve Stimulation (TENS) in     patients having undergone Video-Assisted Thoracotomy Surgery (VATS) with the aim to determine     if:        -  Nurses will be able to apply TENS effectively and in a timely manner to post VATS          patients.        -  Use of TENS immediately after thoracic surgery and for the first 48 hours will add to          patient's pain control.        -  Tens will reduce medication use.        -  Tens will reduce nausea and vomiting.   "
244268|NCT01046708|"     The purpose of this study is to assess the effect of luteal phase supplement (LPS) on     pregnancy rate in IUI cycles stimulated with clomiphene citrate.   "
244282|NCT01046890|"     The purpose of this clinical trial is to characterize drug interactions between one medicinal     herb widely used by HIV infected patients: Echinacea sp. and the protease inhibitor     darunavir/ritonavir.   "
244249|NCT01046461|"     Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result     in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in     acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when     coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis.     Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and     tolerability and a longer duration of effect than granisetron in preventing acute vomiting in     patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in     84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase     emesis was less than 60%.      Aprepitant is a selective, high-affinity NK1 receptor antagonist. Adding aprepitant to 5-HT3     receptor antagonists and steroid improve CR rate of not only chemotherapy induced acute     emesis and but also delayed emesis by 11-14 and 20 percentage points, respectively.      But until now, there was no information that which 5-HT3 receptor antagonists is the best     partner for aprepitant. Therefore, we initiated a prospective, open-label, phase II study to     assess the efficacy and tolerability of a combination of ramosetron, aprepitant and     dexamethasone (RAD) in the prevention of cisplatin based CINV in chemotherapy-naïve patients     with solid cancer   "
244250|NCT01046474|"     The main objective is to evaluate the effect on BMI of a school-based program that     discourages the consumption of all sweetened beverages, encourages the reduction in sugar     intake, and encourages the increase in physical activity among adolescents and their families     from a low socioeconomic area.   "
244251|NCT01046487|"     The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate,     given in association with a fixed dose of cyclophosphamide (50 mg bid).   "
244252|NCT01046500|"     Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of     living cells and is widespread in many food. It is involved in a number of biological     processes, including insulin signal transduction, resulting in modulating insulin     sensitivity. One hundred post-menopausal women from 50 to 60 years old, affected by metabolic     syndrome (criteria are described in NIH ATP III) will be randomized into two groups: 50     treated with myo-inositol 2 g twice per day and fifty treated with metformin for six months.     Metformin is the drug usually used in diabetic and pre-diabetic conditions, as metabolic     syndrome. The investigators hypothesize that the administration of myo-inositol would improve     the insulin-receptor activity in these women, reducing insulin resistance as well as     metformin.      OUTCOME MEASURE: HOMA-IR, blood pressure level, serum triglycerides and cholesterol, BMI and     waist circumference   "
244253|NCT01046513|"     Background:      - Central nicotinic acetylcholine receptors (nAChRs) are the primary target for the action of     nicotine. In addition to being involved in tobacco dependence, they are also involved in a     variety of brain disorders, including Alzheimer's and Parkinson's diseases. Researchers are     interested in developing better ways to study the action of nAChRs to improve treatments for     smoking cessation and other problems affected by these receptors. These new study methods may     involve different radiotracers, which are drugs that can help show brain activity during     positron emission tomography (PET) scanning.      Objectives:      - To evaluate the feasibility of using a radiotracer, 2-[18F]F-A-85380, in PET scanning of     the brain.      Eligibility:      - Healthy volunteers between 21 and 45 years of age who do not use tobacco.      Design:        -  Participants will be asked to avoid consuming alcohol or using a number of          over-the-counter medications, including antihistamines, cough medicines, and nasal          decongestants, for 5 days before the study day. Participants provide urine and breath          samples at the start of the study to be tested for chemicals that may interfere with the          study.        -  Participants will visit the clinical center the morning of the day before the scanning          session to provide blood and urine samples as required. Participants will return and be          admitted for an overnight stay later that afternoon or evening.        -  On the day of the study, participants will receive a single dose of the radiotracer          2-[18F]F-A-85380, and will have a series of PET scans over the next 7 hours and provide          blood samples during that time. Participants will spend that night at the clinical          center and leave on the morning after the end of the study.        -  Participants will return for follow-up visits 2 weeks and 1 month after the end of the          study.   "
244254|NCT01046526|"     Background:        -  Individuals who have schizophrenia are significantly more likely to smoke than the          general population, which leads to increased smoking-related illnesses and high rates of          nicotine dependence. Research suggests that high rates of smoking and nicotine addiction          in people with schizophrenia are related to the fact that nicotine temporally improves          performance in several cognitive tasks, including sensory gating, long-term memory, and          visual tracking-all of which are affected by schizophrenia.        -  Smoking among schizophrenia patients may be a form of self-medication, since nicotine          may temporarily treat and improve cognitive deficits caused by schizophrenia.          Researchers are interested in studying the effects of nicotine on the brain activity of          individuals with schizophrenia to better understand how nicotine affects the brain          regions connected to memory, visual tracking, and attention.      Objectives:        -  To identify specific brain regions involved in the anticipatory learning deficits found          in schizophrenia patients who smoke.        -  To determine whether and how nicotine enhances performance in these regions.      Eligibility:      - Smokers (at least 10 cigarettes per day) between 18 and 50 years of age who either are     healthy volunteers or have been diagnosed with schizophrenia/schizoaffective disorder.      Design:        -  Participants will be asked to avoid consuming alcohol and restrict consuming caffeinated          beverages for 24 hours before the study days. Participants will provide urine and breath          samples at the start of the study to be tested for chemicals that may interfere with the          study.        -  The study will require two to four visits, with two fMRI sessions and other visits for a          clinical interview or training.      Participants will have a training session with a possible mock MRI scan to learn how to do     tasks that track eye movement and measure ability to pay attention.        -  During the fMRI scanning sessions, participants will receive either a nicotine patch or          a placebo patch without nicotine. After the patch is in place, participants will perform          tasks while receiving MRI scans. The scans will take up to 2 hours.        -  Participants will provide blood samples after finishing the MRI sessions.   "
244255|NCT01046539|"     This is a single site, double-blind, randomized, placebo-controlled, crossover study to     assess the pharmacodynamics (PD) of RDC-0313 coadministered with buprenorphine in 12 healthy,     opioid-experienced, non-treatment-seeking subjects.   "
244256|NCT01046552|"     ERCP plays an important role in management of common bile duct stones. Herein the     investigators compare preoperative against intraoperative ERCP.      210 were included but only 198 patients were randomly divided into two groups; PES/LC (100     patients) and LC/IOES (98 patients).      The total hospital stay were significantly shorter in the group of LC/IOES   "
244269|NCT01046721|"     Exenatide is a new drug which lowers blood sugar (glucose) levels for people with type 2     diabetes. It has significant advantages over other treatments such as insulin as it causes     weight loss in a group of people that is generally overweight. Data from studies involving     exenatide have shown that it also has an effect on blood pressure. The mechanism for the     blood pressure lowering effect is not known and has not been investigated previously.     Exenatide may have an effect on blood vessels throughout the body and gut to reduce blood     pressure. 12 healthy men (18-45yr) will be studied on 2 occasions. Limb blood flow, skin     blood flow, gut blood flow, blood pressure, and heart rate will be measured half hourly for 4     hours. Blood samples (3ml) for insulin and glucose determination will be taken via a cannula     and 3-way tap at the same time points. A dose of either 5μg exenatide or saline will be     injected under the skin of the abdomen and a breakfast will be provided during the study. A     urine collection will be made over the duration of the study.   "
244258|NCT01046578|"     A single center, open label randomized clinical trial designed to examine ovarian follicular     dynamics following attempted atresia induction during the late follicular and early luteal     phase of the menstrual cycle using an aromatase inhibitor.      We hypothesize that administration of an aromatase inhibitor (AI) at biologically important     times of the natural menstrual cycle will cause ovulatory failure in women with preovulatory     follicles and failure of luteogenesis in women who have recently ovulated. It is proposed     that atresia of the dominant follicle and formation of anovulatory structures will be     associated with arrested endometrial development and a shortened interval to menstrual     bleeding (3 days). We anticipate that this will provide us with information to facilitate the     development of a new method for emergency contraception and a greater understanding of human     folliculogenesis.      The rationale for the proposed research project is based on the ovarian synchronization     concepts developed and documented in the bovine model in the Reproductive Science and     Medicine Research group at the University of Saskatchewan combined with novel human ovarian     wave concepts of folliculogenesis first elucidated in the Women's Health Imaging Research     Laboratory (WHIRL) in the Department of Obstetrics, Gynecology and Reproductive Sciences.   "
244259|NCT01046591|"     The purpose of this study is to determine whether cleft palate repair increases the risk for     obstructive sleep apnea in children and whether sleep apnea could explain learning and     behavior difficulties that are often observed.   "
244260|NCT01046604|"     In the absence of treatment, severe mitral valve regurgitation (MR) results in left atrium     (LA) dilatation and hypertrophy, followed ultimately by left ventricular dysfunction and     heart failure. One promising intervention for the prevention of the deleterious effects of     pressure overload-induced cardiac hypertrophy and heart failure is dietary supplementation     with n-3 polyunsaturated fatty acids (PUFAs). However, the molecular targets and mechanisms     by which n-3 PUFAs exert their effects are not completely defined. A possible target of n-3     PUFAs is the mitochondrial membrane which has broad implications given that mitochondrial     dysfunction and altered metabolism have been associated with cardiac hypertrophy and heart     failure. The investigators have recently identified significant mitochondrial dysfunction in     the LA of patients with severe MR, as compared to their non-hypertrophied right atrium (RA).     However, the investigators have not addressed the possibility that intervention with purified     n-3 PUFAs (Lovaza) could improve mitochondrial function. From a mechanistic perspective, the     investigators have observed in vitro that n-3 PUFAs accumulate predominately into the     mitochondrial membrane of cardiomyocytes where the investigators believe they exert their     effects on the biophysical organization of the membrane. Therefore, the CENTRAL HYPOTHESIS is     that administering Lovaza to patients with severe MR will reduce apoptosis and improve     mitochondrial function in LA (Aim 1). This change in mitochondrial function will be driven by     significant biochemical and biophysical remodeling of the mitochondrial membrane (Aim 2).   "
244261|NCT01046617|"     Infantile colic is characterized by excessive crying (defined as crying that last at least 3     hours a day, for 3 days a week, for at least 3 weeks) in an otherwise healthy infant. The     crying typically starts in the first few weeks of life and ends by 4-5 months of age. The     condition is usually self-limited, with no long-term adverse effects; however, it may be very     distressing to parents, hence, any safe and effective treatment would be desirable. Recently,     it has been suggested that probiotics may offer some benefit.This is based on the results of     one open randomized controlled trial. In this trial, 83 breast-fed infants with colic defined     as >3 hours of crying on >3 days/week were randomly allocated to receive Lactobacillus     reuteri DSM 17938 (108 colony-forming units, once daily 30 minutes after feeding) or     simethicone (60 mg/day as 15 drops twice a day after feeding) for 28 days. Mothers followed a     cow's milk free diet. By day 28 after randomization, mothers of infants in the probiotic     group were significantly more likely than mothers of infants in the simethicone group to     report a reduction from baseline in average crying time to less than 3 hours per day (95% vs.     7%). In addition, median crying times were significantly shorter in the probiotic group than     in the simethicone group. No adverse effects of L. reuteri were reported.      Although the mechanism of action of L. reuteri for treating infantile colic has not been     elucidated yet, the findings are very promising. However, there are some methodological     limitations to the study, including no allocation concealment, no blinding, and no     intention-to-treat analysis; these may result in selection, performance, and/or attrition     biases and, eventually, invalidate the results. Another limitation of the study is the lack     of a true placebo group. Given these consideration a new study is proposed that is aiming to     overcome these limitations.   "
244262|NCT01046630|"     The purpose of this study is to determine the effect of a single dose infusion of AZD 6765     compared with placebo and ketamine on the blood oxygen level dependent signal using fMRI     (functional Magnetic Resonance Imaging) in depressed subjects.   "
244263|NCT01046643|"     The objective of this study is to evaluate the neurobiological effects of hormone therapy     (HT) in healthy early postmenopausal women. The studies proposed in this project seek to     define the association between different hormone forms (estradiol only and progesterone only)     versus placebo on brain functional measures. The functional measures will include the     performance of the volunteers on a comprehensive neuropsychological testing battery, and the     brain functional responses to episodic memory (verbal and non-verbal) challenges as well as     emotional processing determined with functional magnetic resonance imaging (fMRI).   "
244264|NCT01046656|"     Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In     children, it is commonly caused by enteric pathogens, especially rotavirus. The reported     incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Nosocomial diarrhea may     prolong the hospital stay and increase medical costs. One of the potential strategies for the     prevention of nosocomial infections is the use of probiotics. The number of studies have     shown the efficacy of Lactobacillus reuteri (DSM 17938) in the treatment of acute diarrhea.     However, there are no data on the efficacy of L. reuteri in the prevention of nosocomial     diarrhea. The investigators, therefore, plan to perform the study with the aim of evaluating     the role of Lactobacillus reuteri DSM 17938 administration in the prevention of nosocomial     gastroenteritis in a pediatric hospital setting.   "
244265|NCT01046669|"     To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in     subjects with septic shock who have high levels of endotoxin and are treated with standard     medical care plus use of the PMX cartridge, versus subjects who receive standard medical care     alone.   "
244266|NCT01046682|"     This is a phase II, open label, randomized-controlled pilot study designed to study both the     efficacy and safety of salsalate in decreasing endothelial cell dysfunction, systemic     inflammation, and insulin resistance in HIV-infected adults. The investigators hypothesis is     that salsalate will reduce inflammation and therefore endothelial cell activation and insulin     resistance. The sample size will be 40, with an equal number of people being randomized to     one of two groups. The first arm will be randomized to salsalate therapy. The second arm will     act as a control group. The study duration will be 13 weeks.   "
244270|NCT01046734|"     An influenza pandemic has recently been declared, involving the novel A(H1N1) 'swine flu'     virus. This has spread to almost 100 countries worldwide in less than two months, causing     widespread disease so far in Mexico, USA and Canada. It is highly likely that over the next     12 months, many countries including the UK will be affected by widespread illness. In the UK     this wave of intense flu activity is most likely to occur in late autumn 2009.      Very little is known about the new H1N1 pandemic virus. For example we do not know how long     the virus is excreted by infected humans and how much virus is spread to surfaces and carried     in the air. This is very important to know as soon as possible because it affects the advice     that will be given to healthcare workers about controlling the spread of infection to     themselves and other patients. Similarly we need this information so we can give good quality     advice to families who will have to look after each other in their own homes.      The best way to obtain this information is to ask patients who get pandemic flu soon (in     August, September and October) to help us by agreeing to give a daily nose swab sample for     just over one week so we can see how much virus is in the nose day by day and how quickly     this disappears. At the same time we will take samples from hard surfaces in a patient's room     or home and sample the air using a special filter device. We can then work out how much virus     is being excreted, how long the 'danger period' is, whether surfaces are more or less     important than the air that we breathe (in terms of catching the virus) and if we can advise     on a 'safe distance' from the patient, beyond which there is relatively little chance of     catching the illness.   "
244271|NCT01046747|"     Hypothesis      There is no difference in the incidence of pin tract infection and pin loosening in case of     lower extremity external fixators when self-drilling schanz pins are used with or without     pre-drilling.      Primary Objective      The primary objective is to determine whether pre-drilling holes for external fixation pin     insertion is superior to not pre-drilling holes for external fixation pin insertion in     regards to the incidence of pin tract infection and pin loosening.      Secondary Objective      If any difference is found between the two techniques then, we will quantify and qualify     those differences. The incidence of pin site infection and pin loosening in general will be     determined and will also be stratified for site and size of pin. An attempt to identify risk     factors for pin site infection will be made by observing the effect of secondary prognostic     factors like mode of injury, diabetes, smoking, compartment syndrome, peripheral vascular     disease, neurovascular injury. Interobserver reliability of the grading system for pin     infection will also be determined.   "
244272|NCT01046760|"     Rolandic Epilepsy is the most common form of childhood epilepsy. It is classified as     idiopathic, age-related epilepsy syndrome with benign evolution. The absence of     neuropsychological impairment is part of the criteria of benignity of this epilepsy syndrome.     However recently have been suggested several deficits related to attention and language. The     purpose of this study was assess school performance and to investigate problems of praxis in     patients with rolandic epilepsy as compared to a control group composed of normal children     with age, gender and educational level equivalents.   "
244273|NCT01046773|"     IBD is caused by an abnormal immune response to the gut bacteria in people who are     genetically predisposed. There has been a huge increase in the number of people diagnosed     with IBD since World War II, likely due to changes in our environment. It is possible that     the abundance of vitamin D in the body may be one of those environmental factors that the     investigators can control to make patients with IBD better.      Vitamin D acts on cells of the immune system and causes many effects, including the     production of a natural antibiotic called cathelicidin. The investigators know that when     people are supplemented with vitamin D, levels of cathelicidin produced by these immune cells     increase. By supplementing children with Crohn's disease with vitamin D, the investigators     may be able to alter their immune system naturally, making their disease better. A     consensus of vitamin D experts believes that vitamin D levels need to reach a level of 40-70     ng/mL in the blood in order to have effects on the immune system. Raising vitamin D levels to     this range is one of the goals in the current study.   "
244274|NCT01046786|"     To investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood     mononuclear cell transplant in the treatment of chronic spinal cord injuries.   "
244275|NCT01046799|"     The purpose of this study is to determine whether hepatitis B immunoglobin can be     discontinued early after hepatitis B virus (HBV) induced liver transplantation and be     replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection.   "
244276|NCT01046812|"     The investigators propose a novel assessment of oral malodor (halitosis) by a quality of life     (QOL) questionnaire designed specifically for halitosis and a new treatment for halitosis by     improvement of mouth dryness.   "
249030|NCT01115907|"     The purpose of this clinical investigation is to demonstrate the safety and effectiveness of     the Freedom SOLO heart valve.   "
244277|NCT01046825|"     This is a phase III clinical trial using risk-adapted therapy. Treatment outcomes for     children with B-cell NHL are excellent. Further improvements in outcome will likely be     achieved through more focused study of the biology of the tumors and prospective studies of     the late effects of treatment. Toward this end, this study features a spectrum of prospective     biologic and late effect studies performed in patients treated with a modified regimen     derived from the very successful LMB-96 regimen.   "
244278|NCT01046838|"     In patients with Doppler echocardiographic signs of elevated LV filling pressures despite     preserved LV systolic function after AMI treatment with the phosphodiesterase inhibitor     sildenafil 40 mg three times daily for 9 weeks will compared with placebo        1. Improve resting LV filling and cardiac hemodynamics.        2. Improve exercise capacity.        3. Improve filling pattern and cardiac hemodynamics during exercise.   "
244279|NCT01046851|"     Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist     Nopan to be an effective antidepressant with a rapid onset of action. It is therefore     hypothesized that Nopan may be a novel and quick-acting treatment for acute suicidality.     Depression, suicidality, and overall functioning will be assessed before, during and after a     four-week Nopan/placebo trial. It is hypothesized that subjects who receive the active drug     will show rapid improvements in objective and subjective measures of these variables.   "
244280|NCT01046864|"     The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when     combined with standard dose 5FU/LV and FOLFIRI.   "
244284|NCT01046916|"     This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and     efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without     radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).   "
244285|NCT01046929|"     Limonene is a major component in the essential oils of citrus fruits. It has demonstrated     promising breast cancer preventive and therapeutic effects in preclinical model systems. This     early phase clinical study will evaluate the distribution of limonene to the breast tissue     and its associated biological activities after 2 to 6 weeks of limonene dosing in women with     a recent diagnosis of early stage breast cancer. This study will help evaluate the potentials     of developing limonene as a breast cancer preventive agent.   "
244286|NCT01046942|"     The purpose of this study is to determine whether adding clopidogrel to aspirin after     coronary bypass operation (CABG) improves graft patency, in patients that have preoperatively     increased platelet activity(hypercoagulable) and therefore greater risk of graft occlusion(     thrombosis).   "
244287|NCT01046955|"     The purpose of this study is to observe in a randomized prospective study the effectiveness     and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of     living donor (LD) kidneys, compared with the investigators standard treatment protocol of     Zenapax® and maintenance immunosuppression.   "
244288|NCT01046968|"     Metabolic syndrome is directly related to obesity. This study investigated the use of a plant     based formulation to improve on the condition of people with metabolic syndrome.   "
244289|NCT01046981|"     Tumescent Antibiotic Delivery (TAD) is a technique for improving the prevention of surgical     site infections (SSI). TAD involves the subcutaneous infiltration of tumescent local     anesthesia (TLA) containing water soluble antibiotic(s) such as cefazolin and metronidazole.     TLA consists of the subcutaneous infiltration of very dilute lidocaine (≤ 1 gram/liter) and     epinephrine (≤ 1 milligram/liter) with sodium bicarbonate (10 milliequivalents/liter) in a     physiologic solution of sodium chloride which produces intense local anesthesia associated     with profound wide-spread vasoconstriction lasting for more than 12 hours. Compared to     intravenous antibiotic delivery (IVAD), TAD is expected to produce higher local tissue     concentrations of the antibiotic(s) for longer periods of time and lower systemic/serum     antibiotic concentrations. This clinical trial will compare TAD to IVAD with respect to     pharmacokinetic evidence for possible improved SSI prevention.   "
244290|NCT01046994|"     A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35     (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply     overweight patients. A new prospective study was then planned with the aim to gain insight in     the mechanism of action of BPD in T2DM patients in the 25-30 BMI range. Thirty patients will     be submitted to BPD and compared with 10 nonoperated controls. Euglycemic-hyperinsulinemic     clamp, OGTT, and mixed meal test will be performed in all subjects preoperatively, and 1     month, 1 year, and 5 years after BPD. Complete clinical and biochemical evaluations will be     performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the     fifth year.   "
244291|NCT01047007|"     The study evaluates safety of MK1775 in monotherapy, and in combination with 5-FU alone or     with 5-FU/CDDP in Japanese patients with solid tumor   "
244292|NCT01047020|"     The primary goal of this study is to provide comprehensive and objective information on     impairments of musculoskeletal health, sensory function, and fitness among a large group of     childhood ALL survivors, and to define high risk groups by assessing treatment factors that     contribute to impaired function. This study includes a direct, objective evaluation of     musculoskeletal function, sensory capacity, fitness, and physical activity patterns among     adults who were treated for childhood ALL at St. Jude Children's Research Hospital (SJCRH)     between 1980 and 1999. Among 899 ALL survivors, all of whom are eligible for an     institutionally funded clinical study of medical late effects, the study will recruit 364 to     participate in our evaluations. The study will also recruit 364 individuals for a comparison     group, frequency matching on race/ethnicity, age and gender.   "
244295|NCT01047059|"     The patients will be treated with erlotinib and bevacizumab for a six-week period. Imaging     procedures will be performed at baseline, after one week of therapy and after the six weeks     of treatment.      The combination of erlotinib and bevacizumab represents an effective therapeutic strategy in     NSCLC with the highest response rates ever reported for relapsed NSCLC having been observed     recently in a phase II trial. Early differentiation of patients profiting and of patients not     profiting from this therapy is of major relevance for further improving this targeted therapy     approach and to develop more effective, personalized treatment strategies. We aim at this     early identification by the combination of molecular and functional imaging tools (FDG-,     FLT-PET, DCE-MRI), molecular marker analyses in tissue and peripheral blood (EGFR- and KRAS     mutational status and high throughput mutational profiling in tumor tissue,     angiogenesis-associated biomarkers and expression profiling in peripheral blood) and     pharmokokinetic analyses. From the combined analyses of these tools we expect a better     understanding of the host-drug interaction as a precondition for further improvement of     erlotinib-bevacizumab combination therapy in NSCLC   "
244296|NCT01047072|"     The purpose of the study is to see how well reduced intensity conditioning followed by a stem     cell transplant from a donor (allogeneic) works in treating patients with severe systemic     sclerosis. In an allogeneic stem cell transplant procedure, stem cells are taken from a     healthy donor and transplanted into the patient. Stem cells can be donated by a family member     or an unrelated donor who is a complete tissue type match.   "
244297|NCT01047085|"     Publications with different conclusions are available with regard to the correlations between     the cholecystolithiasis, cholecystectomy and gastroesophageal reflux disease (GERD). In this     study, the controversial relationship between cholecystolithiasis, cholecystectomy and GERD     is discussed through the impedance pH method which started to be used in recent years, a     method indicating the gas and liquid (acid and non-acid) gastroesophageal reflux (GER) and     esophageal clearance time.   "
244298|NCT01047098|"     Most breastfeeding women are told by their health care provider to continue taking prenatal     vitamins after they give birth. A woman's requirement for iron while breastfeeding is low,     yet prenatal vitamins contain a large amount of iron. The purpose of this study is to see if     breastfeeding women are getting too much iron when taking prenatal vitamins.   "
244299|NCT01047111|"     Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection     remains the basic method of management of this malignancy. Although different approaches have     been described for the surgical resection of esophageal cancer, there is no statistical     evidence based on large scale prospective randomized trials with regard to the issue that     which is the optimal surgical approach for esophageal cancer. The purpose of this study is to     test two different approach of transthoracic esophagectomy (Right Side Thoracotomy plus     Midline Laparotomy Approach: Ivor-Lewis Procedure and Left Side Thoracotomy Approach: Sweet     Procedure) in middle or lower third intrathoracic esophageal cancer. This research is being     done to see whether one approach is superior than the other approach with better long-term     outcome and acceptable postoperative short-term outcome or not.   "
244300|NCT01047124|"     The purpose of this study is determine whether a specialised mood disorder service, which     offers tailored psychological and pharmacological treatment, is more effective in the     treatment of chronic unipolar depressive disorder then treatment as usual.   "
244301|NCT01047137|"     Several studies have shown a relationship between psychological stress and chronic urticaria     (hives). The primary objective of this study is to evaluate the effect psychological stress     intervention has on chronic urticaria.   "
244302|NCT01047150|"     Research Questions:        1. Is there a significant difference between the causal repeat rate of myocardial perfusion          studies for Tc99m tetrofosmin and Tc99m sestamibi?        2. Is there a significant difference in the causal repeat rate of myocardial perfusion          studies for Tc99m tetrofosmin and Tc99m sestamibi if an independent technologist          reviewer blinded to the radiopharmaceutical makes the decision to repeat the study?        3. Is there a significant difference in the quantitative diagnostic measures reported          between the original and the acceptable repeated studies?   "
244303|NCT01047163|"     A major contributor to frailty and immobility in the elderly is the age related loss of     muscle mass (sarcopenia). Cardiovascular disease (CVD) is the leading cause of mortality in     the elderly, with high blood cholesterol and lipids being the major modifiable risk factor.     Statins reduce blood cholesterol, but muscle related pain, tenderness and discomfort     (myopathy) is an adverse event associated with statin therapy, with older people being at a     much greater risk. Statin myopathy presents as muscle aches and weakness, with or without     evidence of muscle damage; however the underlying mechanisms responsible for these symptoms     are poorly understood. Using an animal model, the applicants have shown the main pathway     regulating muscle protein synthesis is inhibited in statin myopathy, and genes regulating     muscle protein breakdown, the inhibition of muscle carbohydrate use and inflammation are     dramatically increased. Therefore we wish to determine whether these changes are seen in the     muscle of older people with symptoms of statin myopathy, and whether this is associated with     lower muscle mass and impaired muscle function compared with older people with no history of     statin use. Identification of the mechanisms involved in statin myopathy could lead to     effective therapy for older people unable to tolerate statins.   "
244304|NCT01047176|"     To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after     drug-eluting stents implantation who take statins.   "
244305|NCT01047189|"     The purpose of this research study is to evaluate the effectiveness of two different types of     topical acne medication. This study will help to determine if one combined medication results     in better acne improvement than two separate medications for acne.   "
244306|NCT01047514|"     This study will evaluate the effectiveness of an online Chronic Disease Self-Management     Program for participants in Canada living with chronic health conditions. This pilot will     look for improvements in health status, health behaviors and health care utilization.   "
244369|NCT01048333|"     -  Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single          dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced          Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.        -  Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the          FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1          curve from 0 to 120 minutes)   "
244307|NCT01047527|"     The transdermal nicotine patch is the most widely used form of tobacco dependence treatment     in the US and Europe, but most smokers are unable to successfully quit with this form of     treatment. Failure to respond to this treatment may, to a large extent, be due to the use of     nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a     controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase     quit rates significantly. We propose here a clinical trial to replicate and extend these     results to a community setting in the real-world, using the same research design utilized in     clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate     dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks),     extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The     main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness,     safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for     maintenance therapy with transdermal nicotine will also be assessed. The study results may     change how we treat nicotine dependence with transdermal nicotine.   "
244308|NCT01047540|"     The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention     of reactivation of genital herpes   "
244309|NCT01047553|"     This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one     inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be     the group to refer to when safety results of formoterol arm will be evaluated. 240 patients     with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120     patients on standard COPD therapy).   "
244310|NCT01047566|"     The primary objective of this study is to:      Assess whether the addition of dronedarone to existing conventional rate control therapy     leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at     rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.      The secondary objectives of this study are to compare both study arms with regard to:        -  Ventricular rate after 3 months        -  Number of registered AF episodes        -  Number of symptomatic AF episodes        -  Severity of AF and AF-like symptoms        -  Rate of premature study discontinuation        -  Number of symptomatic episodes of bradycardia        -  Incidence of low heart rate (<60 bpm)   "
244311|NCT01047579|"     This study is designed to evaluate caregiver preference for Exelon® patch (target patch size     10 cm²) treatment in patients with Alzheimer's disease (MMSE 10-26) who were under     cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.   "
244312|NCT01047592|"     Hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the     pathophysiology of schizophrenia. To date, several reported trials on adjuvant NMDA-enhancing     agents, including glycine and sarcosine (a glycine transporter I inhibitor), demonstrated     clinical benefits for schizophrenia patients. This project aims to compare the efficacy and     safety of sarcosine and combination of sarcosine and BE, as adjunctive therapy for     schizophrenia, and to explore the possible synergistic effects of them. Sixty chronic     schizophrenic inpatients will be enrolled in the 12-week double-blind, placebo-controlled     trial. The participants receive stable antipsychotic regimens concomitant with sarcosine (2     g/d) (N=21), sarcosine(2 g/d) + BE(1 g/d ) (N=21), and placebo(N=21). Measures of clinical     efficacy and side-effects were determined every 3 weeks. Measures of cognitive function were     determined at the beginning and the end of the study. The efficacies of three groups are     compared, and the characteristics of better responders are analyzed.   "
244313|NCT01047605|"     To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance     and Pascoflair 425 mg) in comparison to placebo on brain activity.   "
244314|NCT01047618|"     Venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep vein thrombosis     (DVT), is a common complication and leading cause of death in cancer patients. Large,     population-based studies have shown that patients with cancer have four- to seven-fold     increased risk of developing VTE compared with patients without cancer. VTE would be frequent     in patients with advanced gastric cancer, especially associated chemotherapy. However,     relatively few studies have been conducted regarding the incidence of VTE in Asian cancer     patients. According to previous review, Asian patients significantly lower risk of developing     VTE. The rate of VTE with advanced gastric cancer, and associated chemotherapy is not known     in Asian patients. In addition, the impact of VTE on overall survival has not been documented     in these patients.   "
244315|NCT01047631|"     Diastolic heart failure is now being recognized as a key form of heart failure in older     people. The focus of this research is to study ways to improve and maintain physical activity     and functioning. This knowledge may improve the health and well-being in people with     diastolic heart failure.   "
244316|NCT01047644|"     The purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes     every 3 months rather than every four to six weeks.      It is routine practice to flush ports every four to six weeks, according to the     manufacturer's recommendations, using salt solution followed heparin if needed. This study     examines the effectiveness of port flushes at an alternative interval of 3 months, reducing     the number of visits to the health-care provider.   "
244317|NCT01047657|"     Sixty percent of patients with difficult to control asthma seen in our outpatient clinic are     obese. The impact of weight reduction in this subpopulation of asthmatics has not been     studied. Our aim is to evaluate the impact of weight reduction on asthma control of these     patients.   "
244327|NCT01047787|"     The investigators prospectively evaluated 89 consecutive outpatients (29 female) with stable     congestive heart failure. The presence of sleep disordered breathing (SDB) and Cheyne-Stokes     respiration (CSR) while awake were investigated by overnight polysomnography. Males and     females were similar in age, body mass index, and LVEF. Prevalence of SDB was higher in males     than females. During follow up of 25±10 months, 27% of the population died. Nonsurvivors had     lower LVEF (p=0.01), worse NYHA class (p=0.03) a higher proportion of CSR-awake (p<0.001)     than survivors.   "
244389|NCT01048593|"     This study will test the efficacy and safety of IBI-10090 for the reduction of ocular     inflammation after cataract surgery.   "
244570|NCT01056705|"     Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of     phase Ⅱ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis     Vaccine made from Sabin Strains(Sabin IPV).   "
244318|NCT01047670|"     Septic shock is a frequent reason for admission on pediatric intensive care units.     Interventions which can change morbidity and mortality of septic shock patients are of great     interest. Steroid replacement in adults with severe sepsis and septic shock have been     extensively studied. It was recently demonstrated that low dose steroid (< 300mg/ day) used     for more than 5 days was associated with decreased mortality and lower requirement of     vasoactive support in the adult population that had a low response to the ACTH test. However,     this was not confirmed in the latest results from the CORTICUS study. Use of low dose     hydrocortisone, or any other steroid has not been studied in critically ill children.     Mortality associated with sepsis in children has decreased in the last decade and currently     it is close to 10%, making it difficult to power a study able to show reduced mortality.     Taking into account the results from previous studies reporting the high incidence of adrenal     failure and its association to worse outcome, we have designed a clinical trial to evaluate     the effect of low dose hydrocortisone in children with septic shock: Cortisol Replacement in     Children with Sepsis Study.   "
244319|NCT01047683|"     The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to     placebo in lowering fasting triglyceride levels in patients with very high fasting     triglyceride levels ≥ 500 and ≤ 2000 mg/dL.   "
244320|NCT01047696|"     The purpose of this study was to determine whether reduced exposure to indoor air pollution     would reduce ALRI incidence in children <18 months of age. Households were randomized to     receive a chimney stove (intervention group) or continue using an open fire for cooking and     heating (control group).   "
244370|NCT01048346|"     Hypothesis 1. Consumers with disabilities and co-occurring SUD receiving IPS will be more     likely to be competitively employed (defined as 1 or more days of work over the past 30 days)     at 3, 6 and 12 months following the initiation of vocational treatment goals when compared to     a group receiving standard services.      Hypothesis 2. Consumers with disabilities and co-occurring SUD receiving IPS when compared to     the comparison group will 1.) be more successful in achieving their employment goals as     indicated by the ratio of hours worked to desired hours worked; 2.) become competitively     employed sooner; 3.) earn higher wages, 4.) have greater job satisfaction, 5.) have greater     economic satisfaction; 6.) have greater life satisfaction, 7.) have greater self-esteem, and     8.) have fewer days of using substances during follow-up points.   "
244321|NCT01047709|"     Stroke is the leading cause of adult disability and the third leading cause of death in the     United States. Unfortunately, there are few therapies that have been proven to improve stroke     outcome. Sleep apnea is an emerging stroke risk factor and has a well established association     with higher mortality and poor functional outcome following stroke. Over half of acute stroke     patients have sleep apnea, suggesting that it may be a important target for therapy.     Attenuation of sleep apnea severity may result in improved stroke outcomes. However, the     standard treatment for sleep apnea is not well-tolerated among stroke patients. An     alternative treatment is avoidance of supine sleep. Supine sleep is very common in acute     stroke patients, and therefore this treatment may have particular relevance to the stroke     population. The proposed study will be conducted in two phases. The first phase is a     randomized, crossover design in which acute stroke patients will be given positional     treatment (to avoid supine sleep) on one night during their stroke hospitalization. This will     be compared with another night of sleeping without positional therapy. The order of     treatments (standard vs positional therapy) will be random. The first phase will demonstrate     the proof of concept: that stroke patients given positional therapy to avoid supine sleep     will (1) sleep less on their backs, and (2) will have improved sleep apnea parameters with     positional therapy. In the second phase, those identified to have sleep apnea will be     randomized to receive positional therapy at home for three months, or standard therapy. This     second phase will demonstrate the adherence/feasibility of three months of positional     therapy, and will allow us to estimate effect size based on a functional outcome measure. The     data obtained from this pilot clinical trial are essential to plan a large efficacy study.   "
244322|NCT01047722|"     Purpose of the present research project is to study a new in-vivo test for abnormal platelet     function and to study the effect of certain drugs on clinical bleeding. This is a randomized     clinical trial of a new in-vivo test of platelet function known as the bleeding volume     test(BVT)which relies on an on-line measurement system. This trial will assess the     sensitivity and specificity of the new BVT by studying the effects of aspirin which is known     to affect platelet function in-vivo. This is not a clinical trial of drugs. This is a     clinical trial of a novel in-vivo on-line laboratory test.      The BVT measures the total volume of blood in the discrete blotches of blood on the blotter     paper during the BT test and thus the BVT gleans valuable additional information from the     bleeding time test (BTT)procedure. We hypothesize that the BV test will be a more accurate,     specific and sensitive test for diagnosing platelet function abnormalities and for detecting     a person's bleeding tendency compared to the BTT, and commercially available in-vitro     platelet function tests.   "
244323|NCT01047735|"     This research study is being performed to begin to determine the effectiveness of two     dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce     weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in     moderately obese patients.      T2DM is currently the 6th leading cause of mortality in the United States and is a major     cause of kidney failure, blindness, amputations, heart attack, and other vascular and     gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle     modifications with or without glucose lowering agents. Neither treatment alone, or in     combination, results in complete resolution of diabetes and its potential long-term     complications. Bariatric surgery has been proven as an effective treatment to accomplish     sustained and significant weight loss for those with severe obesity and has been shown to     induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment     options, it is not clear whether diabetes is influenced by the type of surgery or by the     amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss     induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class     I and Class II obesity, or approximately 65-95 pounds overweight depending on your height).     More well-controlled studies are needed to more completely inform health care decision making     and clinical practice in this area. This research study aims to obtain preliminary     information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic     Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive     lifestyle intervention to induce weight loss with diet and increased physical activity.   "
244324|NCT01047748|"     The purpose of our study is to determine the optimum route for the injection of digoxin prior     to second-trimester surgical abortion.   "
244325|NCT01047761|"     Generalized fatigue in myasthenia gravis results in physical deconditioning that reduces     fitness and increases risk of obesity, hypertension, elevated cholesterol and type 2     diabetes. This study will examine how active and fit are 30 individuals with chronic,     generalized myasthenic subjects. This study will also determine whether a 3 month home     exercise program with aerobic, resistive, and pulmonary training can improve physical     activity, strength, fitness, lung function and reduce cardiovascular disease risk.   "
244326|NCT01047774|"     The incidence of chronic pain after breast cancer surgery (CPBCS) is high in women diagnosed     with breast cancer. Similar to other chronic postoperative pain conditions, existing     treatments for CPBCS do not always work. Adopting the concept of using pain relieving     measures prior to surgery rather than after it, may lead to decreased postoperative pain     levels. Soy has been shown to have pain-relieving properties and may reduce the risk for     developing chronic post-surgical pain. The purpose of this study is to determine the effects     of adding soy protein to the diet before surgery on the development of chronic pain.   "
244328|NCT01047800|"     Background:      Functional gastrointestinal disorder (FGID) is the most common gastrointestinal disease in     daily clinical practice. The disease is symptomatic but has no identifiable cause by standard     diagnostic tests such as endoscopy. It is characterized by its frequent relapses and thus the     disease causes a significant level of stress and anxiety to patients. Due to the complexity     and chronicity of the disease, it is believed that appropriate counseling on the nature and     management of the disease is necessary to decrease patient's anxiety level and improve     quality of life.      Indication:      Patients who have symptoms suggestive of FGID including non-erosive gastroesophageal reflux     disease (NERD), functional dyspepsia (FD) or irritable bowel syndrome (IBS).      Aim:      To validate the effectiveness of counseling in patients suffering from FGID.      Method:      Patients recruited to the study will follow the usual management of patients attending the     Gastroenterology specialty clinic in Prince of Wales Hospital. Standard blood tests and     endoscopy will be performed. Standard medication will be given to the patients for 8 weeks     after endoscopy and the patients will come back to the specialty clinic for a final visit.      The patient will be given an on-demand follow up within 1 year option at final visit. The     patient will decide if he/she wants to come back to our specialty clinic to follow up his/her     problem within one year.      Follow-up after Final Visit Follow-up questionnaires will be mailed to patients 6 months, 1     and 2 years after Final visit.      Randomization:      All the patients will be randomized into two groups in First Visit: 1) Control group, and 2)     Counseling group. Both groups of patients will follow the above protocol, except that 2 extra     counseling sessions will be arranged for the Counseling group immediately after visiting the     physician.   "
244371|NCT01048359|"     The primary purpose of the project entitled: Multidisciplinary Approach to Reduce Injury and     Substance Abuse, which is funded by the National Institute on Drug Abuse (5R01DA026088-02),     is to compare the effectiveness of brief intervention, brief intervention plus a booster, and     brief advice for adult patients who abuse drugs and present to a trauma department for     treatment of an injury.   "
244372|NCT01048372|"     Primary Objective: To determine the mechanism of Cytolin's effect on HIV replication from     blood drawn from HIV-positive and HIV-negative individuals after exposure to Cytolin.   "
244329|NCT01047813|"     Consumption of a low glycemic index (GI) diet has been shown to improve glycaemic control in     type 2 diabetics(Brand−Miller et al., 2003; Jenkins et al., 2008). In addition to the     benefits for glycaemic control there is some evidence for acute improvements in cognitive     performance after consumption of low GI foods compared with high GI foods in both adults     (Benton et al., 2003; Kaplan et al., 2000) and adolescents (Ingwersen et al., 2007; Smith and     Foster, 2008).      Given these findings it is possible that low GI focused dietary interventions designed to     improve glycaemic control and health outcomes for diabetic patients could also improve the     cognitive function of these patients. This is of particular relevance in light of the     evidence associating type 2 diabetes with cognitive decrements (Awad et al., 2004; Stewart     and Loilitsa 1999; van Harten et al., 2006). To date two studies with type 2 diabetics have     reported that a low GI breakfast was associated with increased verbal memory performance     compared to a high GI breakfast (Greenwood et al., 2003; Papanikolaou et al. 2006). Further     research should investigate the benefit of low GI foods to cognition.      The aim of this study is to examine the effects of high and low glycaemic index breakfast on     cognitive performance in adults with type 2 diabetes. Participants will perform a battery of     cognitive tests after consuming 3 different breakfasts (high GI, low GI, and water) on 3     different tests days. The participants will be recruited from the general public and from the     Leeds Teaching Hospital diabetes clinic.      This research can benefit the development of specific dietary behaviours aimed at reducing     diabetes related cognitive decline. This research is part of a PhD funded by the Economic and     Social Research Council and the University of Leeds.   "
244330|NCT01047826|"     The investigators are comparing two methods of standard treatments in distal tibial     fractures. locked plating (M.I.P.O. technique) with intramedullary nailing.      the investigators are hypothesizing that M.I.P.O group is superior to nailing in fractures of     the distal third of the tibia.   "
244331|NCT01047839|"     The primary objective is to assess the safety profile of IC51 in a pediatric population from     regions where JEV is not endemic   "
244332|NCT01047852|"     The purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the     prevention of extubation failure and mortality in patients with either chronic respiratory     disorders or hypercapnic respiratory failure during spontaneous breathing.   "
244333|NCT01047865|"     The hypothesis is that humoral and cellular islet-specific responses are an early risk factor     for recurrence of autoimmunity and hyperglycemia in simultaneous pancreas-kidney (SPK)     recipients independent of alloimmunity. This study will test the hypothesis and will assess     their individual and combined predictive value.   "
244334|NCT01047878|"     To determine whether gene expression analysis of primary tumor samples before and after     chemotherapy are predictive of long-term survival in pediatric patients with bone sarcomas     (Ewings sarcoma (ES) and Osteosarcoma(OS)).   "
244335|NCT01047891|"     It is assumed, that the patients of the standard arm show a median progression-free survival     time of 4.4 months those of the experimental arm of at least 6.9 months. Assuming a     recruitment period of 18 months and follow-up for at least 12 months a total sample size of     174 patients is required (two-sided, α=0.05, 80% power). To account for 5% drop-outs 184     patients will be randomized.      A Data Monitoring and Safety Board (DMSB) will be established. This board will evaluate the     safety profile of the drug combination after 6 patients and after 12 patients have received 1     cycle of treatment.   "
244336|NCT01047904|"     The study will evaluate the performance and reliability of minor design changes to the     Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy     volunteers. Data collected from this study will enable the development of future applications     and technology.   "
244337|NCT01047917|"     The purpose of this study is to test a simple meditation program that is easy to learn;     inexpensive; easy to practice; non-religion based; and has wide applicability to multiple     medical conditions. This program has been developed by the Complementary and Integrative     Medicine Program at the Mayo Clinic.   "
244338|NCT01047930|"     The primary aim of this project is to test the effect of exercise on acute nicotine     withdrawal. Acute nicotine withdrawal is characterized by a complex array of symptoms     associated with increased risk of relapse among individuals attempting smoking cessation. The     available remedies do not target all aspects of withdrawal. For example, pharmacologic     treatments reduce withdrawal-based craving, but have no effect on cue-related craving,     altered sleep, and mood disturbances during withdrawal. Therefore, non-pharmacologic     behavioral techniques with the potential to attenuate persistent withdrawal symptoms are     needed. We hypothesized that exercise can be a valid non-pharmacologic strategy to improve     these domains.   "
244339|NCT01047943|"     The clinical assessment of patients with plaque-type psoriasis is performed by open,     intrapatient comparison of 0.2% STA-21 with vehicle(Vaseline) alone within a 2 week period.   "
244340|NCT01047956|"     Evaluation whether higher retention rate is in those of combined methadone with     N-Acetyl-Cysteine compared to those with methadone alone during a six-month study.   "
244341|NCT01047969|"     An assessment of the safety of omission of surgery following a complete response to     chemotherapy and radiotherapy, or radiotherapy alone, for rectal cancer.   "
244342|NCT01047982|"     Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of     living cells and is widespread in many food. It is involved in a number of biological     processes, including insulin signal transduction, resulting in modulating insulin     sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two     hundred and twenty obese pregnant women will be included in the trial and, after an informed     consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks     gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at     24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be     registered.   "
244399|NCT01048723|"     The goal of this clinical research study is to learn if the study drug RAD001 can stop or     slow the growth of resectable soft tissue sarcoma. The patient's physical state, their     symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study     will help the research team decide if RAD001 is safe and effective in patients with this     condition. The study drug, RAD001, is made by Novartis Pharmaceuticals Corporation.   "
244343|NCT01047995|"     The study aims to help us understand if the HIV drugs darunavir (taken with ritonavir) and     raltegravir will affect each other when they are given at the same time.      The purpose of the study is to assess the pharmacokinetics (how a drug is absorbed,     distributed and eliminated from your body) of darunavir and ritonavir when these are taken     with and without raltegravir.      The duration of the study will be up to 50 days plus a screening visit which will take place     up to 4 weeks prior to the start of the study, and a follow up visit which takes place 1-2     weeks after the last dose of study medication.      Subjects will continue to take 2 of their usual drugs (those called nucleoside reverse     transcriptase inhibitors -NRTI) throughout the study.      For the first 21 days subjects will take their usual NRTI plus raltegravir 400mg twice daily.     After this, subjects will also receive either:      Group 1) Darunavir/ritonavir 800mg/100mg once daily AND raltegravir 400mg twice daily or     Group 2) Darunavir/ritonavir 800mg/100mg once daily AND raltegravir 800mg once daily      Subjects will take this regimen for 14 days. Subjects will be randomly allocated to either     Group 1 or 2. You will have an equal (50/50) chance of being allocated to Group 1 or 2.   "
244344|NCT01048008|"     DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate that has demonstrated     antineoplastic activities in human xenograft intracerebrally implanted tumor mouse models,     acceptable preclinical toxicities in mouse, rat and dog models; and no behavioral cognitive     impairment/neurotoxicities were noted in mouse and rat models.      The drug is ready for human use as an soy bean oil/lecithin/glycerin water emulsion, the     latter which has been documented - chemically and biologically to be stable and safe.     Patients are currently being enrolled and treated with the protocol.      Patients with advanced cancer, with or without central nervous system involvement will be     eligible for enrollment, providing the required blood and other eligibility requirements are     met.   "
244345|NCT01048021|"     This clinical trial is being conducted to study lung function and movement of the major     muscle involved in breathing (the diaphragm) after a brachial plexus nerve block (nerve     freezing). The purpose of this study is to find out what effects (good and bad) ultrasound     guided nerve freezing has on the movement of the patient's diaphragm and their lung function.      The potential advantage of ultrasound guidance will be a lesser chance of freezing the nerves     that innervate the diaphragm and thus having less of an effect on lung function.   "
244346|NCT01048034|"     Azacitidine has proved prolonged overall survival in patients with high-risk MDS. Minor pilot     studies have shown that treatment with Azacitidine can induce transfusion independency in     previous transfusion dependent patients with low-risk MDS. This study will evaluate the     effect of Azacitidine in transfusion dependent patients with low-risk MDS (IPSS low or int-1)     or low risk CMML. Included patients should first have failed, or considered not being     eligible to, treatment with EPO +/- G-CSF. Our hypothesis is that Azacitidine can lead to     transfusion independency in this group of patients. Those patients who do not respond to     treatment with Azacitidine alone, will be given treatment with the combination of Azacitidine     and EPO where our hypothesis is that Azacitidine can restore sensitivity to EPO.   "
244347|NCT01048047|"     Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy     on ankle-foot volume in hypertensive patients. It will be enrolled male or female     outpatients, aged 18-65 years.   "
244348|NCT01048060|"     The purpose of this study is to collect bone marrow samples for experimental studies.   "
244349|NCT01048073|"     Acute respiratory infection (ARI) constitutes a leading cause of morbidity, hospitalization     and mortality worldwide. The most common etiologic agents of ARI's, especially in children,     are viruses.      The study objective is to determine the viral and bacterial etiologies of ARIs in patients     with lower respiratory tract infection in South East Asia.      This is a laboratory based surveillance study, in which the archival specimens from     hospitalized patients will be tested for respiratory pathogens other than influenza viruses     Standard descriptive statistics will be used to present the findings   "
244350|NCT01048086|"     This study is for patients with neuroblastoma or a neuroendocrine tumor who have not been     able to have standard therapy or have failed the first-line therapy. The purpose of this     study is to assess the safety and effectiveness of the combination of retinoic acid and     Onalta (Y-90-DOTA-tyr3-Octreotide) in treating neuroblastoma and neuroendocrine tumors.   "
244351|NCT01048099|"     This trial will evaluate the clinical significance of the PRO Onc assay and will assess the     efficacy of HER2-targeted therapy in patients with HER2-negative breast cancer who have been     identified as having HER2 overexpression/activation by the PRO Onc Assay.   "
244366|NCT01048294|"     One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal     Affective Disorder(SAD) or so called winterdepression is a disturbance of circadian rhythms.     Since the circadian system is especially sensitive for the blue portion of the light     spectrum, a new light therapy device with more blue light (blue enriched polychromatic light)     was tested for its efficacy to treat SAD. In chronobiological terms this light is     hypothesized to be more potent in inducing non-visual effects. In the present study     fluorescent tubes that emit a high portion of short wavelength light on top of the normal     wavelengths are tested for its superiority in treating SAD. This blue-enriched light (colour     temperature 17000 ºK) is compared to standard light treatment (5000 º K) in SAD patients.,     The investigators hypothesise that blue- enriched light improve the therapeutic effects of     light treatment leading to a higher response or the same response in a shorter time schedule     compared to standard light treatment.   "
244772|NCT01058707|"     This is a Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent     MLN0128 in Subjects with Advanced Malignancies Followed by an Expansion in Subjects with     renal cell carcinoma, endometrial cancer or urothelial cancer who have measurable disease   "
244436|NCT01049204|"     Impact of Maraviroc, a ART CCR5 inhibitor, on the intensification of immune function in HIV-1     infected subjects receiving immunisation with novel antigens      The purpose of the study is to investigate the impact of adding Maraviroc (an anti-HIV agent)     to a participant's normal HIV medication, on immune function. As part of the study     participants will also receive three different vaccinations and a skin test. The study will     also look at whether Maraviroc influences the body's response to these.      The vaccines are given to stimulate the body's immune system, so we can therefore evaluate     the impact that Maraviroc has on this.      The duration of the study will be just over 24 weeks plus a screening period up to 4 weeks     prior to the start of the study.   "
244352|NCT01048112|"     The goal of this research is to continue to develop a model of infection with Campylobacter     jejuni, a bacterium that causes food and water-borne disease (mainly diarrhea). The     objectives are to 1) determine if healthy subjects develop short-term (<6 month) protection     to reinfection with C. jejuni; and 2) characterize the immune responses to C. jejuni     infection. Information obtained will be used in development of a vaccine against     Campylobacter infections.      Volunteers will be screened for eligibility within 60 days prior to enrollment. Screening     will include obtaining informed consent prior to any study procedure. This will be followed     by medical history, physical examination, review of current medications, blood samples for     safety labs (WBC, Hct, Hgb, platelet count; chemistry panel; screening for HIV, HLA-B27, HBV,     and HCV); urine pregnancy testing for females. Stool will be tested for infection.      Eligible volunteers will be enrolled in the study and admitted to the GCRC on Day -1. They     will drink a measured dose of C. jejuni on Day 0, and followed for approximately 9 inpatient     days, during which time the investigators expect at least 75% to develop a diarrheal illness,     which will be promptly treated with replacement fluids (oral or IV, as indicated) and     antibiotics. During the inpatient period, subjects will be assessed for any adverse events,     and blood and stool specimens will be analyzed for markers of infection and markers of immune     response. Subjects must have resolved or resolving symptoms and two negative stool cultures     ≥12 hours apart to be eligible for discharge, and will be seen in outpatient follow-up at 21,     28, 35, 60, and 90 days for additional AE assessments and blood and stool analysis.      Eight subjects will return for redosing approximately 98 days after the initial dose, with     the same inpatient and outpatient follow-up as above. Few or none should develop a diarrheal     illness. Four naïve (previously unexposed) subjects will also receive the dose on Day 98 to     confirm a 75% illness rate with this dose. They will be followed as the initial group was.     All participants will be assessed by phone 6 months after the final dose they received.   "
244353|NCT01048125|"     Stress (Takotsubo) cardiomyopathy (SC) is a peculiar form of acute, reversible myocardial     dysfunction predominantly affecting the apical and mid left ventricular segments.      In this institution over the last two to three years the investigators have identified more     than a dozen patients with stress cardiomyopathy. The investigators' overarching goal is to     characterize these individuals with the hope of identifying risk factors and developing     strategies to prevent the occurrence of SC in situations where the likelihood in susceptible     individuals may be high.   "
244354|NCT01048138|"     There is no AED or medication that has been demonstrated to affect the development of     post-traumatic epilepsy. Biperiden is a cholinergic antagonist, acting in the muscarinic     receptor, that is widely used as an anti Parkinson drug. The investigators data with animal     models of epilepsy indicate that anti-muscarinic agents might affect the natural course of     the disease in the case of post-traumatic epilepsy.   "
244355|NCT01048151|"     While radiation therapy with androgen ablation (hormone reduction) is the standard method of     treating locally advanced prostate cancer. New treatments are being combined with radiation     therapy in an effort to further improve the cure rates.      This study proposes to combine an experimental drug, TNFerade™ Biologic, (also called     AdGVEGR.TNF.11D or TNFerade) at different dose (amounts) levels in combination with     radiation.      TNFerade™ Biologic is a form of gene transfer therapy that when injected into the tumor has     shown to increase the effect of radiation therapy.   "
244356|NCT01048164|"     The purpose of this study is to evaluate the effect of therapeutic massage in alleviating     musculoskeletal pain and discomfort associated with wearing lead aprons in the cardiac cath     lab. We also want to evaluate if therapeutic massage will reduce fatigue, stress, and anxiety     while improving the level of relaxation in cardiac cath lab employees who wear lead aprons.   "
244357|NCT01048177|"     In order to investigate whether the pain in women with vulvodynia may represent bladder     origin pain, we will be performing a diagnostic test for interstitial cystitis (IC) in women     with generalized vulvodynia. Those women with a positive test for IC, we will be performing a     series of bladder treatments (instillations) for IC and checking symptoms throughout the     trial to see if significant relief of vulvar pain can be obtained through treatment for IC.   "
244358|NCT01048190|"     The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated     Poliomyelitis Vaccine made from Sabin Strains by different does.   "
244359|NCT01048203|"     This is a single site, open label, single dose, non-randomized study in healthy male and     female subjects. The subjects will be evaluated for plasma, urine and feces levels of     14C-ABR-215050 during 21 days.   "
244360|NCT01048216|"     This study is designed to treat tumors in the liver that cannot be removed surgically and     chemotherapy cannot control these tumors, using radiation therapy and a more precise delivery     than has been used before.   "
244361|NCT01048229|"     Title: Evaluation of the tolerance and acceptability of Rasagiline in the treatment of     early-stage Parkinson's disease.      Type of study: Phase IV      Study objectives:      Principal objective:      To evaluate the tolerance and acceptability of Rasagiline versus Pramipexole (dopamine     agonist).      Secondary objectives: To evaluate the clinical benefits of Rasagiline administered as a     monotherapy in patients presenting with early-stage Parkinson's disease.      Study design:      Multicentre comparative randomised parallel-group double-blind study, with a total duration     of fifteen weeks (three weeks of dose titration and twelve weeks of follow-up), comprising     four evaluations (D0, W3, W9, W15).      Number of patients:      240 patients (i.e. 120 in each group) presenting with early stage idiopathic Parkinson's     disease.      Number of centres:      70 neurologists distributed throughout three French regions      Treatment studied: Rasagiline Presentation: 1 mg tablets Dosage : 1 mg/day in a single dose,     in the morning at breakfast-time.      Comparator: Pramipexole Presentation: 0.125 mg, 0.25 mg and 1 mg pramipexole dihydrochloride     monohydrate tablets (corresponding respectively to 0.088 mg, 0.18 mg and 0.7 mg of     pramipexole)      Dose-titration: As specified in the SPC for pramipexole, the product will be administered in     three daily doses, preferably with meals, and the treatment will begin with a dose-titration     phase of three weeks' duration, during which time the dosage will be gradually increased.      On completion of the dose-titration phase, the minimum therapeutic dose of 1.5 mg per day     must be achieved by all the patients. The patients who cannot achieve this dosage will be     withdrawn from the study. The reason for stopping dose-titration (and leaving the study) will     be detailed in the CRF.      Dosage:      The effective dosage of pramipexole should be adapted to the individual, depending on     clinical response and tolerance, in successive stages of 0.75 mg at one-week intervals,     without exceeding the maximum dose of 3 mg per day.      Treatment prohibited during the study :      Pethidine, fluoxetine, fluvoxamine, dextromethorphan, or any other MAOI, sympathomimetics     (including nasal and oral decongestants containing ephedrine or pseudoephedrine), anti-H2s     (cimetidine, ranitidine).      Principal evaluation criterion :      The principal criterion of evaluation is the percentage of patients who have presented with     at least one  significant  adverse event during follow-up.      A significant adverse event is defined as :        -  a severe adverse event (SAE)        -  an adverse event which in the opinion of the investigator requires suspension of the          treatment or reduction in dosage        -  an adverse event considered as severe or moderate by the patient (AEs of which the          intensity has not been evaluated will be considered as moderate to severe)      Secondary evaluation criteria:        -  analysis of adverse events in the total population        -  analysis of adverse events by degree of severity        -  analysis of adverse events in subject over 65        -  analysis of adverse events by symptom        -  percentage of patients presenting with sleep problems (daytime drowsiness, narcolepsy,          insomnia, fragmented sleep…)        -  evaluation of Epworth Sleepiness Scale        -  evaluation of quality of life (PDQ-8)        -  evaluation of utilities by EuroQol (EQ-5D)        -  overall clinical impression evaluated by the doctor (CGI-I) and by the patient (PGI-I)        -  Global-Benefit-Risk (GBR)        -  Evaluation of resources      Analysis of the principal criterion:      Analysis of the principal criterion will be carried out with those patients from the     intention-to-treat population for whom tolerance data is available in at least one visit     after D0.      Comparative analysis The percentages of patients in the two treated groups who present with     at least one significant adverse event will be compared using a Khi-2 test.      Logistic regression A logistic regression analysis will be performed in order to explain the     presence/absence of a significant event. The nature of the treatment and the centre will act     as explanatory variables, and the initial scores as covariates. Analyses will also be     performed on quantitative variables (ANCOVA)      Evaluation of the Global Benefit-Risk (GBR) according to the model suggested by Chuang-Stein     et al.      Number of subject required:      Calculation of the size is based on the hypothesis that the percentage of patients presenting     with at least one significant adverse event during follow-up (principal evaluation criterion)     will differ by 15% from one group to the other. With an alpha risk set at 5% and a beta ris     kat 20%, the number of subjects required, calculated using the Casagrande et Pike formula, is     110 subjects per group.      The NSN was slightly overestimated in order to maintain the desired strength while taking     into account the possibility of lost to follow-up, and was fixed at 240 patients.   "
244362|NCT01048242|"     The objective of the study is to determine if treatment with Ramelteon will help to improve     insomnia in older adults with co-existent insomnia and sleep apnea. The primary study     objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will     be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study     objective is to determine if subject compliance with CPAP treatment of their sleep apnea is     improved in subjects taking Ramelteon (their compliance may be improved because they would     have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that     compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo     arm.   "
244363|NCT01048255|"     The purpose of this study is to determine the safety, tolerability, and efficacy of VX-765 in     subjects with Treatment-resistant Partial Epilepsy   "
244364|NCT01048268|"     The purpose of this study is to determine whether glucose-dependent insulinotropic     polypeptide (GIP) has a stabilizing function on the blood glucose   "
244365|NCT01048281|"     Our research of the biology of upper gastrointestinal cancers involves the study of tissue     samples and cells from biopsies of persons with gastric or esophageal cancer or blood samples     from upper gastrointestinal cancer patients and persons at high inherited risk for these     cancers. We hope to learn the role genes and proteins play in the development of gastric and     esophageal cancer.   "
244367|NCT01048307|"     Objective:      To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment     of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution      Methodology:      Randomised, controlled multi-centre, prospective clinical trial      Planned number of subjects:      20 patients in experimental group (Prontosan® Wound Irrigation Solution) 8 patients in     control group (wound irrigation with saline)      Products under investigation:      Prontosan® Wound Irrigation Solution      Study Duration:      3-4 weeks   "
244368|NCT01048320|"     The main research objective is to work out the optimal doses of the novel combination of     gemcitabine, oxaliplatin and imatinib mesylate (glivec) in patients with advanced pancreatic     cancer that has progressed during or after treatment with first-line gemcitabine.   "
244373|NCT01048385|"     The goal of our research is to increase live birth rates in infertile women and to reduce the     incidence of aneuploidy leading to miscarriage and trisomies. We hypothesize that an age     related mitochondrial dysfunction reduces the availability of energy in the oocyte and     contributes to abnormal segregation of chromosomes during the meiotic division leading to     oocyte aneuploidy. Based on preliminary evidence we have obtained in aged mice, we propose     that dietary supplementation with Co enzyme Q10 in older women will improve mitochondrial     function in the oocytes, leading to a decrease in chromosomal non-disjunction and resulting     in embryos with a normal chromosomal complement. Our primary outcome measure will be     determination of oocyte chromosome number by multiplex PCR based assay of polar bodies     biopsied at the time of IVF. Outcomes of this proposal will enable us to address the     mechanisms of ovarian aging and may explain etiology of decreased fertility in older     patients. In addition, our work will add to the feasibility of single embryo transfer,     thereby avoiding multiple pregnancies and their associated cost to the health care system and     to society.   "
244374|NCT01048398|"     BACKGROUND: Between 3-4% of pregnancies carried to term, the fetuses are in breech     presentation. The external version is a maneuver gynecological used to turn a breech in     cephalic presentation. For treatment of pain suggests the use of μ agonist remifentanil for     fast action and elimination.      OBJECTIVE: To compare the effectiveness of remifentanil for pain management in external     version.      PATIENTS: Pregnant for 36 weeks or more with breech presentation who met the inclusion     criteria and sign the consent. Participants will be randomized into two groups before the     procedure.      Group intervention: paracetamol and remifentanil Control group: paracetamol and placebo     DETERMINATIONS: VAS pain level, percentage of success of the maneuver and adverse events.      Statistical Analysis: Comparison of pain recorded by VAS in both groups and comparison of     adverse events   "
244375|NCT01048411|"     The homeopathic remedy 'naja-comp' will improve functional outcome measured by the     Barthel-Index.      The homeopathic remedy 'naja-comp' will decrease complications during geriatric     rehabilitation measured by rate of unplanned discharge to hospital.   "
244376|NCT01048424|"     Urgency incontinence is a common and burdensome problem in women. Current treatments for this     condition, while effective, are associated with potentially disabling side effects and high     rates of discontinuation. There is an urgent need for alternate treatments for urgency     incontinence that are both clinically effective and well-tolerated by women in the community.      RESPeRATE is a commercially available walkman-like device that measures chest/abdominal     excursion during respiration using an elastic belt with a sensor placed around the torso over     clothing. The device senses respiration and uses musical tones keyed to inhalation and     exhalation to help the user slow respiration and prolong exhalation to a recommended goal of     less than 10 breaths per minute. RESPeRATE is approved by the US Food and Drug Administration     (FDA) for treatment of mild hypertension, and use of the device has also been shown to     decrease self-reported anxiety and stress, oxygen consumption, and respiratory rate. Because     anxiety and stress are strongly associated with urgency incontinence, and common behavioral     strategies for managing incontinence emphasize relaxation and slow breathing at the time of     an urgency episode, paced respiration may also be useful in treating urgency incontinence     and/or decreasing its burden on quality of life.      We propose to conduct a 6-week pilot randomized controlled trial of slow paced respiration     using the RESPeRATE device among 30 women with urgency incontinence to assess the feasibility     of recruiting and teaching women to use the RESPeRATE device as well as to gather preliminary     data on the efficacy of slow paced respiration for treatment of urgency incontinence and     related symptoms. Participants will complete a 7-day voiding diary and complete     questionnaires to measure outcome.   "
244377|NCT01048437|"     This study is a group-randomized controlled trial to explore whether improved community     transplant education for renal patients not yet on dialysis could increase patients'     willingness to pursue preemptive living donor transplant (PLDT) and PLDT rates.   "
244378|NCT01048450|"     The purpose of this study is to examine the long-term outcomes for the surgical treatment of     end stage degeneration in the big toe joint.   "
244379|NCT01048463|"     Malnutrition is frequently seen in patients on chemotherapy suffering from gastric/colorectal     cancer and may worsen the outcome. EPA, a sort of ω-3 PUFA, can modulate immune system. EPA     also antagonizes metabolic and inflammatory changes induced by the tumor. This study is to     test whether EPA, in combination with enteral nutrition, can improve nutritional/immunologic     status, quality of life, and reduce chemotherapy related side effects of these patients.   "
244398|NCT01048710|"     The primary objective of this prospective multicenter study is to assess whether the     functional outcome measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) for     patients with medial unicompartmental osteoarthritis and osteonecrosis of the knee treated     with open wedge high tibial osteotomy (HTO) using the TomoFix™ Small is better than the     functional outcome after conservative treatment.   "
244773|NCT01058720|"     The study is designed to evaluate the increment of serum 25 (OH) vitamin D levels in normal     weight adolescents following a 12-week supplementation with Vitamin D3 2000 IU/day.   "
244380|NCT01048476|"     Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased     interest in evaluating the effect of lutein for optimizing eye health. A large number of     epidemiological studies support the notion that the high intake dietary of lutein is strongly     associated with a decreased relative risk of AMD.Moreover, findings from initial     observational studies have now been followed by placebo-controlled intervention trials     showing that dietary modification and supplementation with lutein result in increasing the     macular pigment optical density, and may help to improve visual function in patients     suffering from AMD.Currently, nutritional status and background information of lutein and     zeaxanthin in Chinese population is lack. Little is known about the preventive and therapy     benefits of lutein on visual function in the AMD populations. In particular, the effect on     visual function of relatively certain doses of lutein and zeaxanthin is unknown. Therefore,     the objective of the present study was to examine the effect of consuming different doses of     lutein on MPOD and visual function in AMD.   "
244437|NCT01049217|"     The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in     reducing neuropathic pain associated with HIV neuropathy.   "
244381|NCT01048489|"     Effectiveness of health education regarding the smoking habit is under discussion .     Nevertheless, according to the literature, some personal, familiar, cultural, and social     factors are considered risk factors for students to become smokers. Probably, a health     education intervention integrated in the school program will show a higher rate of     effectiveness regarding incidence and prevalence of smoking habit in this age-group .      OBJECTIVE: To evaluate the effectiveness of a health education program to reduce the smoking     habit in students.      METHODOLOGY: Quasi-experimental design including all the junior high school students in an     educational district in Tarragona (Spain). The sampled schools will be randomised into two     groups (experimental and control). All the included students will be monitored for three     years.      The health education program will be divided in three interventions: role games and debates     (1st year), workshops regarding the family and the social role of smoking (2nd year) , and     the analysis of smoking advertising (3rd year). The incidence and prevalence rates will be     compared on the experimental and control group, before de beginning of the intervention and     at the beginning of each year.   "
244382|NCT01048502|"     The purpose of this study is to better understand the anti-inflammatory benefits of two     prescription medicines that are currently used to help people with cholesterol problems.      Fish oil, from eating certain kinds of fish and from supplement pills, has been used to help     control cholesterol and reduce inflammation (the body's response to injury or sickness).     Lovaza® is the brand name for prescription strength fish oil pills. In this study, we will be     looking at how Lovaza® works to help reduce inflammation in healthy volunteers.      Tricor® is the brand name for prescription fenofibrate pills. Fenofibrate is a prescription     medicine that many doctors give to people with high triglyceride (fat in the blood) levels.     In this study, we will be looking at how Tricor® works to help reduce inflammation in healthy     volunteers.      Endotoxin or lipopolysaccharide (LPS) is a small part of bacteria (that is no longer living)     that can cause many of the effects similar to bacterial infections in humans. However, it can     be administered in very small amounts to produce a mild immune response much the same as a     'flu' like illness. Within 1 ½ -3 hours after giving LPS by vein, a response consisting of     fever, chills, headache, nausea and vomiting and generalized aches and pains will occur which     lasts up to 6-8 hours. In addition to the flu like symptoms, the response causes temporary     changes in cholesterol, triglycerides and blood sugar. Different people respond differently     to LPS. We are using LPS in this study to bring on a temporary inflammatory response in the     body and to compare the responses of people who receive Lovaza® or Tricor® to the responses     of people who receive a placebo (pill that does not contain medicine).   "
244383|NCT01048515|"     The study investigated the effect of caffeine on physical performance in healthy citizens     aged over 70 years following eight hours of abstinence from caffeine containing drinks and     foods. The main hypothesis was that 6 mg/kg caffeine would improve cycling endurance at 65%     of expected maximal heart rate.   "
244384|NCT01048528|"     The study will examine the effects of a cognitive behavioral stress management (CBSM) group     intervention on antibody and cellular immune function among women who are at elevated risk     for breast cancer because of family history.      Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and     secondary antibody response to HA vaccine compared to women in the comparison group.      Hypothesis 2: In response to stimulation with HA antigen, lymphocytes from women who     participate in the CBSM intervention will have larger primary and secondary in-vitro     proliferative response to HA antigen, and increased primary and secondary in-vitro TH1     cytokine response to HA antigen compared to lymphocytes from women in the comparison group.      Hypothesis 3: Women who participate in the 10-week CBSM group intervention will report lower     levels of distress immediately after the intervention compared to women in the comparison     group. Changes in distress as a result of the intervention will be associated with any     significant changes in immune function discovered in Aims 1 and 2.   "
244385|NCT01048541|"     Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard     minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a     balloon. This length is defined by hospital standards although it is known that the male     urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by     Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There     is a lack of clinical data documenting that male ICs that are shorter and more or less     flexible than standard catheters can sufficiently empty the bladder of male subjects. This     will be tested using ultrasound to measure residual urine in the bladder following     catheterisation with new product and standard length catheter.   "
244386|NCT01048554|"     This research is being done because melanoma in the brain is very difficult to treat because     it does not respond to radiation or to chemotherapy, such as temozolomide. One of the reasons     for this is that the melanoma can make chemicals that signal the brain to provide new blood     vessels for the tumor. The main signal is called VEGF. Bevacizumab is an antibody that blocks     VEGF. The investigators want to see if the combination of bevacizumab and temozolomide will     stop the melanoma from growing.   "
244387|NCT01048567|"     The purpose of this study is to determine whether Lactobacillus acidophilus/rhamnosus complex     is effective in the prevention of antibiotic-associated diarrhea (AAD) in the elderly.   "
244388|NCT01048580|"     This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.   "
244438|NCT01049230|"     The purpose of this research study is to determine if radiation using proton beam therapy     will kill the germ cell tumor in the participant's central nervous system. This type of     radiation has been used previously on many patients with different types of cancers. There     are two types of external radiation treatments, proton beam and photon beam. In this study we     will be examining the effects of proton beam radiation therapy. Studies have suggested that     this kind of radiation can spare normal tissue more than photon radiation therapy. The     physical characteristics of proton beam radiation let the doctor safely increase the amount     of radiation delivered to the tumor. We believe that proton beam therapy will potentially     reduce side effects that participants would normally experience with photon radiation     therapy.   "
244439|NCT01049243|"     The purpose of this research study is to better understand how fluocinonide cream 0.1%     (Vanos®) works when people use it to treat atopic dermatitis for just a few days.   "
244390|NCT01048606|"     Menopause is characterized by a decrease of estrogen and progesterone levels and is     associated with various changes in body composition, including an accumulation of total fat     mass, a relocation of adiposity to the abdomen, deterioration of plasma lipid profile,     increased risk of type 2 diabetes, and increased oxidative stress. Taken together, these     changes increase the risk of developing cardiovascular disease (CVD).      Physical activity and hormone-replacement therapy (HRT) have been shown to act in synergy to     improve total fat mass in postmenopausal (PM) women. Because the progesterone component of     HRT has been associated with an increased CVD risk in older women with a family history of     CVD, the use of HRT has become controversial. As a result, a large decrease of the use of HRT     in the community has been observed and postmenopausal women (PM) have developed interest in     alternative therapies. Among the possibilities, phytoestrogens have shown beneficial effects     on menopausal symptoms and plasma lipids. Phytoestrogens are structurally and functionally     similar to estradiol (the major estrogen in humans) but found only in plants such as soybean     isoflavones. They do not exert any effect on breast cancer or/and endometrial tissue.      AIMS To examine the effects of phytoestrogens, exercise and the combination of both on lean     body mass, total fat mass, visceral fat, blood lipid profile, oxidative stress markers,     antioxidant system, glucose metabolism, and sex-hormone levels in obese PM women.      HYPOTHESES Women undergoing a combination of phytoestrogen treatment and an exercise program     will display a greater increase in lean body mass, decrease in total and visceral fat mass,     improvements in blood lipid profile, decrease in oxidative stress markers, increase in     antioxidant system, improvement in glucose metabolism, and increase in sex-hormone levels     than those submitted to any or one of the treatments.      A total of 120 women will be recruited. There will be 4 groups (30 women/group) undergoing     exercise or not and supplemented with phytoestrogens or a placebo. The intervention is     planned to last 12 mo. Key variables will be measured at baseline, and after 6 and 12 mo of     intervention.      Three weekly 1h-sessions of exercise will be held on 3 non-consecutive days. The     phytoestrogen supplements will consist of 70 mg/d of soy isoflavones taken as 4 caps/day.   "
244391|NCT01048619|"     In other clinical studies, ON 01910.Na has been safely given intravenously to Patients with     advanced cancers. However, to treat some Patients, it may be better if ON 01910.Na could be     given by mouth. This study will determine if it is safe to give ON 01910.Na by mouth, what is     the highest dose can be safely given by mouth, and how much of the drug gets from the stomach     into the blood stream when it is given by mouth.   "
244392|NCT01048632|"     Oxandrolone is an anabolic steroid, marketed in the United States as an adjunctive therapy to     combat weight loss resulting from chronic infection, extensive surgery, severe trauma,     protein catabolism associated with prolonged administration of corticosteroids, and for the     relief of bone pain accompanying osteoporosis. In children, it has been used to prevent and     treat growth failure associated with severe burns (≥ 40% of total body surface area),     Duchenne muscular dystrophy, Turner's syndrome, constitutional delay of growth and puberty,     and chronic wasting in HIV-positive pediatric patients. Other applications in children have     included treatment of central idiopathic precocious puberty, hereditary angioedema, and     bilateral congenital anorchia. Growth failure is a common feature of infants with complex     congenital heart disease, and can adversely affect outcome. This therapy has not been     previously implemented in neonates thus we will evaluate the safety and efficacy of     administering oxandrolone to improve growth in neonates with complex congenital heart disease     who have undergone surgical palliation or repair by collecting anthropometric measurements     and pharmacokinetic data.      Neonates with HLHS or variant with planned Norwood Procedure. The primary aims of this pilot     study are to assess safety and efficacy of oxandrolone in this population. Our goal will be     to enroll 5 patients in each phase of this pilot study. The incidence of adverse events will     also be monitored and compared to untreated patients. Enrollment will continue until the     target of 20 total patients has been met.   "
244393|NCT01048645|"     Purpose:      This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel     plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free     survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an     acceptable toxicity profile and its association with the expression of Retinoic acid receptor     beta 2 (RAR-beta2) as a response biomarker.      Patients and Methods:      Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC).     Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior     to treatment until completing two cycles. RAR-beta2 expression was analyzed by     Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.   "
244394|NCT01048658|"     Sevoflurane is an FDA-approved anesthetic drug commonly used for anesthesia during second     trimester abortion procedures. It has a few advantages, including ease of use by the     anesthesia provider. However, the literature suggests that when used in doses higher than     those used at Oregon Health & Science University (OHSU) and Lovejoy, it is associated with an     increase in the risk of bleeding. The investigators study aims to test whether the lower dose     used at OHSU and Lovejoy during second trimester abortion procedures causes any difference in     blood loss, when compared to similar abortion procedures for which this drug is not used.   "
244395|NCT01048671|"     To evaluate the management of HIV-1 participants treated with antiretroviral combination     therapy including the integrase inhibitor raltegravir, all across the country of France.   "
244396|NCT01048684|"     Neuroanesthesia for supratentorial surgery involves a thorough understanding of the     physiopathology of intracranial pressure, cerebral homeostasis and regulation of cerebral     perfusion pressure as well as the effects of anesthesia and surgery on these elements.      The main objective of anesthesia during neurosurgery is to preserve the integrity of the     brain by maintaining cerebral homeostasis, and assuring cerebral protection using     normovolemia, normotension, normoglycemia, moderate hyperoxia and hypocapnia and     hyperosmolality with the administration of mannitol.      During surgery, the use of surgical retractors must be limited to avoid possible ischemia of     the brain tissue. Surgical retractors can be replaced by chemical retractors. The concept of     chemical retraction involves a reduction of cerebral blood flow, maintaining cerebral     perfusion pressure, moderate hyperventilation, drainage of cerebrospinal fluid and     osmotherapy.      Mannitol, an osmotic agent, has been widely used to reduce the volume of the brain, the     intracranial pressure and to facilitate the surgical approach in reducing the risk of     cortical lesions during the opening of the skull.      Mannitol 20% is usually given intravenously in bolus doses of 0.5-1g/kg over 30 minutes.     However, over the last few years, the concept of a dose-response relationship has emerged.     Some recent studies tend to demonstrate that higher doses of mannitol could reduce     intracranial pressure significantly without any important side effects.      The main objective of the present study is to compare two doses of mannitol (0.7 and 1.4     g/kg) on brain relaxation during supratentorial craniotomies.   "
244397|NCT01048697|"     This study is designed to measure drug concentrations in the blood of healthy volunteers     administered a single dose of ethambutol. Our hypothesis is that volunteers with a body mass     index (BMI) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner     volunteers, and those with a BMI > 40 kg/m2 will have even greater clearance than those who     are leaner.   "
244400|NCT01048736|"     Aging is associated with declines in aerobic capacity, exercise tolerance, and functional     endurance that lead to physical disability and loss of independence. Furthermore, the     existing high prevalence of obesity in the elderly is greatly exacerbating these     aging-related declines in function. To date, regular exercise is the only known therapy to     consistently improve aerobic function, and perhaps delay the onset of disability. Although     aerobic exercise training does benefit both aerobic capacity and endurance even in obese     persons, some data show that the maximal efficacy of exercise for improving aerobic function     is blunted by obesity. In addition, our preliminary data show a potential dose-response     benefit of concomitant fat loss on exercise-induced improvements in aerobic function. Thus,     combining an exercise intervention with caloric restriction resulting in fat loss may be more     efficacious for improving aerobic function than exercise alone in obese elderly, a population     at high risk for disability. The purpose of this study is to determine whether the amount of     fat loss (achieved through controlled underfeeding) affects the magnitude of improvement in     aerobic function (maximal aerobic capacity and endurance) in response to a standardized     exercise training stimulus that follows current recommendations for older persons.   "
244401|NCT01048749|"     The purpose of this study is to test a physical therapy intervention for reducing pain in the     low back and into the legs. With individuals over the age of 40 years, this pain may be     associated to changes in back height from aging of the cushions between the back bones. When     pain is caused from this, completion of different positions and rest periods have been shown     to help reduce the pain, at least temporarily. This study will compare two such positions;     1)floating in deep warm water with weights attached to the ankles, to take the load off of     the spine, 2)lying on their back with hip and knees flexed to a 90 degree angle. The height     of each person will be measured before and after completion of each intervention using a     specially designed measuring tool.      Experimental hypothesis:        1. Subjects with low back and leg pain suggestive of nerve root compression syndrome will          experience increase in spinal height when completing aquatic vertical suspension and/or          land-based supine flexion.        2. Subjects with low back and leg pain suggestive of nerve root compression syndrome will          experience greater increase in height, greater reduction of pain intensity and location          when completing underwater vertical suspension as compared to supine land based flexion.   "
244402|NCT01048762|"     The purpose of this investigation is to determine the effects of exercise training on quality     of life and physical capacity, 3 months and 1 year after radical operation for pulmonary     cancer.   "
244403|NCT01048775|"     The bispectral index (BIS) is derived from a single-channel electroencephalogram (EEG) and     provides information on the anaesthetic depth. Recently, a bilateral two-channel EEG-sensor     has been introduced to monitor the BIS on both cerebral hemispheres. In some patients     significant left-right differences may occur, whereas no relevant side differences are     expected in the majority of patients.      The aim of this study is to        -  investigate the incidence, duration and degree of left-right BIS differences        -  examine the relation between BIS differences and occurrence of cognitive deficits   "
244404|NCT01048788|"     OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with     ascites despite having received conventional diuretic therapy. Based on the change in body     weight, on Day 7 it will be decided whether to continue administration at the same dose or to     increase the dose, and then OPC-41061 will be orally administered for an additional 7 days at     either 7.5 mg/day or, if diuretic effect for the initial 7-day administration is     insufficient, at an increased dose of 15 mg/day. Plasma drug level, efficacy, and safety of     OPC-41061 by 14-day repeated administration will be investigated.   "
244405|NCT01048801|"     Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor     access to health facilities, home management of malaria (HMM) can improve the timeliness of     treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and     impact, ACTs should be deployed in HMM programmes, as well as in formal health facilities. Up     to 80% of malaria cases are treated outside the formal health sector and shops are frequently     visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs     in Africa thus also need to examine the role of shops in home management and to ensure that     drugs sold are appropriate. The current practice of presumptive treatment of any febrile     illness as malaria (both at health facilities and in the context of HMM) based solely on     clinical symptoms without routine laboratory confirmation, results in significant over-use of     antimalarial drugs. With ACT being a more costly regimen, it is important to be more     restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of     confirming malaria diagnosis in remote locations lacking electricity and qualified health     staff.      This study therefore proposes to evaluate the feasibility, acceptability, and     cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by     community-based drug distributors.The accuracy of RDTs, and the acceptability of this     approach, will be evaluated in both low and high transmission areas.   "
244406|NCT01048814|"     The purpose of this study is to improve upon and validate the prognostic and/or predictive     accuracy of a drug response marker by the development of improved alternative algorithms     based on the actual clinical outcome of retrospective cases.   "
244416|NCT01048944|"     The purpose of this study is to better characterize differences in mood, attention, brain     activation patterns underlying the beneficial effects of pharmacological treatments     previously demonstrated to be help individuals successfully quit tobacco smoking. Smokers     will be randomly assigned to one of three treatments: 1) bupropion sustained release (SR), 2)     nicotine patch, or 3) placebo patches plus pills across a 45-day period with a 3-week     intensive post-treatment follow-up. In addition, 20 percent of the subjects will be     randomized to a delayed-quit control group.   "
244787|NCT01060033|"     To detect differences in MR spectroscopy, diffusion weighted MR, diffusion tensor imaging     (DTI) or dynamic contrast enhancement (DCE) MR imaging between primary cervical tumors and     normal cervical tissue.   "
244440|NCT01049256|"     We aim to test our method for measuring chemosensitivity (the ventilatory response to a     change in carbon dioxide), which uses sinusoidal carbon dioxide stimuli.      Hypotheses:        -  Carbon dioxide sensitivity is dependent on the cycle time over which we administer the          gas (frequency).        -  Chemoreflex gain decreases as deadspace increases.   "
244407|NCT01048827|"     Busulfan and etoposide have been used as preparative therapy for autoSCT (stem cell     transplant) in adults with acute myeloid leukemia (AML) at UCSF for the past 10 years. Over     this period and together with collaborative transplant centers, over 200 patients have     received this treatment. By intent-to-treat analysis, and with median follow-up of 7.0 years,     the 5-year DFS is 55%. The current protocol will utilize the combination of IV Busulfan (BU)     and etoposide. The busulfan dose will be escalated amongst 3 targeted dose levels. All     targeted dose levels represent higher busulfan dosing than standard myeloablative dosing,     with the lowest dose being approximately 14% higher than standard. Busulfan levels will be     monitored after the first, fourth and twelfth doses. Dose adjustments will be made in real     time based on AUC levels determined from the first and fourth doses. This strategy of     busulfan monitoring and dose adjustment has improved the therapeutic widow of BU in previous     clinical trials.      The current protocol will utilize the combination of intravenous busulfan and etoposide. The     busulfan dose will be escalated amongst 3 targeted dose levels (area under the curve (AUC)     levels at time 6 hours of 1250 uMol*min, 1400 uMol*min and 1550 uMol*min). All targeted dose     levels represent higher busulfan dosing than standard myeloablative dosing with the lowest     dose (1250 uMol*min) being approximately 14% higher than standard. In the absence of     dose-limiting toxicity, cohorts of 4-6 patients will be treated at each dose level and 10     additional patients will be treated at the maximum tolerated dose (MTD) to confirm safety.     The busulfan dosing will begin at 1 mg/kg based on historical plasma levels obtained from     patients receiving BU at a starting dose of 0.8 mg/kg at UCSF Medical Center.      The highest dose level proposed for this study will exceed the reported toxic level for     busulfan in the alloSCT setting. Patients will be followed closely for toxicity and strict     stopping rules have been included. Eligibility criteria will exclude patients with prior     history of hepatotoxicity or viral hepatitis. Potential hepatotoxic agents will not be     allowed just prior to and during the busulfan dosing period. In addition, patients who     experience hepatotoxicty during pre-transplant mobilization therapy may be excluded from     receiving dose-escalated busulfan therapy. Every attempt will be made to prevent or avoid     hepatotoxicity.   "
244408|NCT01048840|"     The goal of this project is to determine the long-term health outcome of children diagnosed     with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in     the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have     compiled a database of more than 200 subjects that completed diagnostic testing for GER in     the 1970's and 1980's. Subjects are being contacted initially by mail using a previously     approved recruitment letter. Subjects that fail to respond to this recruitment letter are     called by phone. In each case, contact information has been abstracted from the Children's     Hospital database. Subjects are then given the opportunity to complete a questionnaire either     by phone or in hard copy. Subjects receive no compensation for their participation in this     study. Subjects will be compared to controls. Controls will complete the same questionnaire     as the subjects. Inclusion of potential controls will be determined by a lack of medical     history of gastroenterological diseases before the age of 21 and whether the potential     control was born within a year of a subject in the study. Controls will receive $25 to     participate in the study.   "
244409|NCT01048853|"     The goal of this surgical research study is to learn if conservative surgery is a safe and     feasible option for women with low-risk cervical cancer (stage IA2 or IB1, Grade 1 or 2).   "
244410|NCT01048866|"     The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg     lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen     lozenge throughout the course of treating sore throat due to acute pharyngitis.   "
244411|NCT01048879|"     Critically ill patients with flu may receive a drug called oseltamivir. They may also receive     medical therapies to support their lung function (extracorporeal membrane oxygenation; ECMO)     and kidney function (continuous venovenous hemodialysis; CVVHD). CVVHD and ECMO may remove     some oseltamivir from the bloodstream. The purpose of this study is to determine how much     oseltamivir gets removed by CVVHD or ECMO in critically ill patients.   "
244412|NCT01048892|"     RATIONALE: Seneca Valley virus-001 may be able to kill certain kinds of tumor cells without     damaging normal cells. Adding low dose cyclophosphamide (in part B of study) may help to kill     even more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of Seneca Valley     virus-001 in treating young patients with relapsed or refractory neuroblastoma,     rhabdomyosarcoma, or rare tumors with neuroendocrine features.   "
244413|NCT01048905|"     The primary hypothesis of this study is that glutamine supplementation will improve the     erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and     pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients with     PH. PH is defined as a tricuspid regurgitant jet velocity (TRV) on Doppler echocardiography >     2.5 m/s. We also predict that glutamine therapy will increase arginine bioavailability and     subsequently alter sickle red cell endothelial interaction that can be identified using     endo-PAT technology through nitric oxide (NO) generation, leading to changes in biological     markers, and clinical outcome. Specifically our second hypothesis is that oral glutamine will     decrease biomarkers of hemolysis and adhesion molecules, and improve the imbalanced     arginine-to-ornithine ratio that occurs in hemolytic anemias, leading to improved arginine     bioavailability and clinical endpoints of endothelial dysfunction and PH in patients with SCD     and Thal.   "
244414|NCT01048918|"     The purpose of this study is to identify tumor cells in the bloodstream (Circulating Tumor     Cells, CTC's) from patient's with locally advanced or metastatic (stage IV) breast cancer.     Analyzing the tumor is helpful in guiding therapy; however, research has suggested that the     number of tumor cells found in the bloodstream (CTC's) signifies more aggressive behavior and     increased difficulty in eliminating the cancer. This research will help to develop better     ways to treat breast cancer which could be tailored to a patient and may be adjusted to a     patient's individual needs.   "
244415|NCT01048931|"     Minimally invasive surgery has become the standard treatment for many gynecologic disease     processes. In the last decade, numerous studies have demonstrated that laparoscopic     approaches to various gynecologic oncology conditions-particularly for early-stage     endometrial and cervical cancers as well as select pelvic masses-is feasible and results in     shorter hospital stays, improved quality of life and comparable surgical and oncologic     outcomes to abdominal staging [1-5].For instance, the typical gynecologic robotic surgical     procedure will require Two to three 5-mm ports and one 12-mm laparoscopic ports. Recently, an     even less invasive alternative to conventional laparoscopy surgery has been developed:     laparoendoscopic single-site surgery (LESS), also known as single-port surgery. Single port     laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive     surgery while minimizing the potential morbidity associated with multiple incisions. However,     to our knowledge, there are no randomize control trial to evaluate of single port or multiple     ports laparoscopic surgery in gynecologic disorders. The purpose of this study was to assess     the feasibility of SPA-LAVH in the treatment of benign uterine disease.   "
244452|NCT01049412|"     Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new     basal insulin analog and when they take insulin glargine   "
244417|NCT01048957|"     Background:      - One kind of drug craving, known as cue-elicited craving, occurs when a drug user who sees a     drug-related cue (such as an image of someone using the drug) begins to feel a craving for     the drug. Researchers are interested in studying how cue-elicited craving affects brain     activity using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG)     data.      Objectives:      - To determine which parts of the brain are associated with or involved in controlling     cue-related craving in smokers.      Eligibility:      - Individuals between 18 and 50 years of age who are current smokers (10 or more cigarettes     per day) and agree to try to abstain from smoking for 1 week during the experiment.      Design:        -  Participants will visit a clinical center for up to four scanning sessions, and will be          asked to perform two or three outpatient tasks at home over the course of the study.        -  Scan 1: Training session with a mock fMRI scanner, followed by an actual fMRI scanning          session and EEG in which participants respond to pictures.        -  Outpatient Task 1: Tolerance test with nicotine patch (worn for 8 hours, followed by 12          additional hours without cigarette use).        -  Scans 2 and 3: Training session and fMRI scan and testing with either nicotine patch or          placebo. Tasks in fMRI involve looking at cues, reporting craving and suppressing          craving.        -  Outpatient Task 2: Participants will keep an electronic diary for 10 to 14 days,          responding to questions as directed by the researchers.        -  Scans 4 and 5: Training session, fMRI scan and EEG, and testing in which participants          will be instructed on methods to attempt to control cravings.        -  Outpatient Task 3: Participants will keep an electronic diary for 14 days. For the first          7 days, participants will be asked to attempt to abstain from nicotine; participants may          smoke normally on the second 7 days.        -  Participants will be contacted 1, 3, 6, and 12 months after the end of the study for          follow-up questions on current smoking habits.   "
244418|NCT01048970|"     Background: A frequent manifestation of advanced lung cancer is malnutrition, timely     identification and treatment of which can lead to improved patient quality of life, response     rate to chemotherapy and survival. N-3 fatty acids, especially eicosapentaenoic acid (EPA)     and docosahexaenoic acid (DHA), may possess anticachectic properties. This trial compared a     protein and energy dense supplement enriched with n-3 fatty acids with nutritional assessment     for their effects on weight, lean body mass (LBM), body fat, phase angle, dietary intake,     inflammatory response and quality of life in first-line chemotherapy patients with advanced     lung cancer.      Methods: Chemonaive patients with stages IIIB and IV of lung cancer are going to receive     Paclitaxel and Cisplatin. Patients will be randomized to receive two cans/day of EPA and DHA     containing oral supplement or nutritional assessment one week prior to treatment until     completing two cycles. Serum levels of Reactive C Protein (RCP), interleukin-6 (IL-6) and     tumor necrosis factor alpha (TNF-alpha) are going to be measured baseline and after two     courses of chemotherapy. Phase angle and body composition will be measured using Bioimpedance     analysis (BIA). Quality of life, dietary intake will be assessed with validate     questionnaires. All data is going to be collected in a database for further blind analysis.     Written informed consent will be collected from all patients.   "
244419|NCT01048983|"     The goal of this clinical research study is to compare armodafinil, bupropion, curcumin, and     minocycline when given alone or in combination to learn which is better for controlling     symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.   "
244420|NCT01048996|"     Acute Lung Injury (ALI) and the more severe Acute Respiratory Distress Syndrome (ARDS) are a     significant problem in Pediatric Intensive Care Units, affecting up to 16 of every 1000     children admitted to these units. These disorders carry with them high mortality rates as     well as numerous long-term effects for the surviving children. As the effects of these     diseases have significant social and economic ramifications for affected children and their     families, research on the development of ALI/ARDS could significantly change how physicians     understand the disease and treat patients.      There are a wide range of problems which make certain PICU patients more likely to develop     either ALI or ARDS. This research aims to determine which of these children are at the     greatest risk for ALI/ARDS by examining differences in plasma biomarkers and in DNA of a     large number of PICU patients. We are hypothesizing that significant differences in the level     of specific plasma biomarkers or in the frequency of specific DNA variants exist in children     who develop ALI/ARDS.   "
244421|NCT01049009|"     High blood pressure (hypertension) is called the silent killer because many people do not     know they have it, and do not know when it is well controlled. Unfortunately, over time     uncontrolled hypertension can cause irreversible organ damage that can lead to heart attack,     stroke, heart failure, and kidney failure. If a person cannot control their blood pressure     with diet and exercise, doctors often prescribe medications to help control the blood     pressure. Nebivolol is a medication that has been recently approved by the FDA for the     treatment of hypertension. Our study will investigate whether treatment with nebivolol, as     compared to another medication called metoprolol, in African Americans with hypertension will     be more effective in protecting blood vessels against the harmful effects of high blood     pressure.      Over time high blood pressure causes hardening of the arteries (atherosclerosis) which leads     to narrowing of the blood vessels and reduces blood flow to our organs. Arteries also relax     and contract naturally, which further changes the blood supply. When arteries are narrowed,     exercise can bring on a condition in which the blood supply is inadequate, and this might     result in the sensation of pain.      Cells lining our blood vessels produce a variety of substances that normally cause arteries     to relax. Two of these substances are called nitric oxide (NO) and endothelium-derived     hyperpolarizing factor (EDHF). We are trying to determine the nature of these substances in     African Americans with high blood pressure and how it is affected by nebivolol and     metoprolol. One way to determine this is to inject drugs such as L-NMMA     (N(G)-monomethyl-L-arginine) or TEA (tetraethylammonium chloride), which block the production     of NO and EDHF respectively, and then study what happens to the blood flow at rest and during     exercise. It is our thought that nebivolol, in comparison to metoprolol, will increase the     substances that naturally cause arteries to relax and improve blood supply.   "
244422|NCT01049022|"     The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to     see what the best dose should be for children in the future. Pharmacokinetics is to see how     the body absorbs, distributes, breaks down and gets rid of the study drug. The     pharmacokinetics of certain drugs may be altered in children due to developmental differences     in various organ functions responsible for drug elimination, as well as in general     distribution characteristics. The safety of moxifloxacin in children with infections will     also be looked at. Results from this study will be used to guide dosing strategies of the     larger clinical trial planned for children   "
244423|NCT01049035|"     The purpose of this study is to evaluate the optimal vaccination schedule for a Quadrivalent     Meningococcal (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in order to     provide an effective protein conjugate quadrivalent meningococcal vaccine in the population     with the highest incidence of disease.      Objectives:        -  To describe the safety profile of TetraMen-T vaccine administered at 5 different          schedules and concomitantly with routine pediatric vaccinations.        -  To describe the immunogenicity profile of TetraMen-T vaccine administered at 5 different          schedules and concomitantly with routine pediatric vaccinations.        -  To describe the immunogenicity profiles of selected licensed pediatric vaccines          (Pentacel, Prevnar, M-M-RII and Varivax) when administered either concomitantly with or          without TetraMen-T vaccine.   "
244477|NCT01049737|"     The purpose of this study is to prospectively explore the impact from the different     cardiovascular risk factors on early cardiovascular organ damage in 761 middle aged patients     with type 2 diabetes.   "
244424|NCT01049048|"     In the United States, cardiovascular disease causes over one-third of all deaths and vitamin     D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status     adversely impacts the cardiovascular system. It is our fundamental hypothesis that vitamin D     deficiency is a risk factor for cardiovascular disease by causing endothelial dysfunction.     Moreover, we hypothesize that vitamin D supplementation will restore endothelial function,     thereby reducing cardiovascular disease risk.      This pilot research will be conducted in 64 post-menopausal women participating in an     existing study of vitamin D supplementation (32 will receive vitamin D3 2,500 IU daily, the     others matching placebo) and will explore the effects of vitamin D on endothelial function     and arterial reactivity. Post-menopausal women aged 55-65 years are chosen due to their     highest risk for development of a subsequent new cardiovascular disease diagnosis. All study     participants will have fasting laboratory and noninvasive vascular ultrasound studies     performed at baseline and four months later. The primary outcome measure of this pilot study     is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy.     If our hypotheses are correct, our long-term goals include investigation of the effect of     vitamin D repletion on subclinical atherosclerosis and subsequent cardiovascular events.   "
244425|NCT01049061|"     MORAb-003 is intravenously administered to Japanese patients with folate receptor-alpha     expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate     dose-limiting toxicity and estimate maximum tolerated dose.   "
244426|NCT01049074|"     Hypothesis: Acupuncture procedure of He's Santong Methods could be an option to treat     nonspecific low back pain.   "
244427|NCT01049087|"     The purpose of the present study is to compare plasma volume determination by 99mTc-labeled     albumin with 125I-labeled albumin. Fifteen subjects will be enrolled. The hypothesis is that     plasma volume determined by the different methods are the same.   "
244428|NCT01049100|"     The aim of this study is to determine whether the modified therapy on the basis of operative     staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical     cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a     significant improvement of disease-free survival.   "
244429|NCT01049113|"     This is an open-label, dose-escalation Phase 1 study of the investigational agent, ON 013105.     In laboratory animal studies, ON 013105 has demonstrated anti-cancer activity. The purpose of     this study is to determine the highest dose of ON 013105 that can be given safely in patients     with relapsed/refractory Lymphoma or B-cell Acute Lymphocytic Leukemia (Philadelphia     chromosome negative). Patients will receive weekly 2-hour IV infusions of ON 013105 at higher     and higher doses until intolerable side effects are observed. It is important to know the     highest safe dose so additional studies can be done.   "
244430|NCT01049126|"     The purpose of this study is to assess the relationship of assay sensitive patients versus     assay resistant patients with progression free survival.   "
244431|NCT01049139|"     This study will carry out a preliminary proof of concept to evaluate two types of     supplemental information that would serve as an adjunct to the traditional informed consent     in a Human Immunodeficiency Virus (HIV) vaccine clinical trial. These will be compared to the     condition where the traditional informed consent form is used alone.      Using four intervention sites, participants will be administered a standard HIV vaccine trial     consent form. They will then be randomized into three conditions: 1) No supplemental     information; 2) Supplemental information with 1-sided messages (emphasizes information     content related to vaccine trial randomization and unproven efficacy of vaccine); and 3)     Supplemental information with 2-sided messages (acknowledges the beliefs that are at odds     with the information content and seeks to neutralize those beliefs through counter-argument).     An interviewer-administered questionnaire (IAQ) Part 1 will be administered before the     traditional HIV vaccine trial informed consent is reviewed with the participant. An IAQ Part     2 will be administered directly after the HIV vaccine trial informed consent in the control     condition or after reading through the supplemental material. Debriefing interviews will be     conducted with selected participants to review their understanding of the study procedures     and their reactions to the supplemental materials and/or questionnaires.      The proposed research is a proof of concept study and is therefore not designed to test     hypotheses. Consequently, formal hypothesis and related power calculations to detect certain     effect sizes are not required. Instead, the goal will be to enroll an appropriate number of     subjects for purpose of determining the feasibility of developing a larger study of     supplemental information to be used as an adjunct to the informed consent statement in HIV     vaccine clinical trials and providing related descriptive statistics.   "
244432|NCT01049152|"     Evaluation of different glycemic variations between the dialysis period and non-dialysis     period in two groups: nondiabetic and diabetic patients undergone two different hemodialysis     methods. Thirty-six patients, males and females, aged 50-80 years, with end stage renal     disease (ESRD) will undergo hemodialysis and continuous glucose monitoring (CGM). The     investigators will evaluate also inflammation markers before and after the different     hemodialysis methods.   "
244433|NCT01049165|"     The primary purpose of this study is to evaluate the safety and tolerability of single oral     doses of BMS-813160 in healthy subjects   "
244434|NCT01049178|"     The purpose of this study is to determine if intake of the antioxidant enzyme inducer,     silymarin, will improve lung function and symptom scores in participants with asthma.   "
244435|NCT01049191|"     Osteoporosis is a common disorder of compromised bone strength causing 40-50% of women and     ~25% of men to sustain fragility fractures during their lifetime. The reduction of bone     strength in osteoporotic people results from loss of bone density and deterioration of bone     quality. Bone quality is a complex amalgamation including macro- and micro-architecture,     mineralization, turnover and damage accumulation. Currently, medications to reduce fracture     risk are prescribed primarily on the basis of bone mineral density (BMD) measurement.     Unfortunately, currently available BMD measurement technologies do not detect the     aforementioned properties of bone quality; as such, less than half of individuals who sustain     osteoporotic fractures are classified as osteoporotic by currently available diagnostic     tools. Clearly, measures to enhance identification of those at high fracture risk are needed.     High-resolution magnetic resonance imaging (HR-MRI) technology, such as that provided by     MicroMRI, Inc., has outstanding potential to be such a tool. Therefore, our long-term goal is     to evaluate and optimize the use of HR-MRI in fracture risk prediction; this pilot work is an     essential step in attaining this goal.      This research will investigate 72 postmenopausal women with normal or osteopenic BMD by     dual-energy x-ray absorptiometry (DXA), 36 with prior low-trauma fractures will be compared     with 36 age-, race- and BMD matched women without fracture. We hypothesize that 1.) Women     with fractures will have evidence of microarchitectural deterioration on HR-MRI and 2.) Newly     developed, more rapid MRI sequences designed at the UW will provide similar trabecular     microstructure information more rapidly than the currently used, albeit investigational,     technology produced by MicroMRI, Inc.      Our specific aims are to a) Evaluate differences in MicroMRI parameters of trabecular     microstructure (bone volume fraction, trabecular thickness, surface/curve ratio and erosion     index) between age-, race- and BMD-matched postmenopausal women with and without fracture;     b.) Correlate T2* relaxation time (a rapid indirect MRI measure of trabecular density and     microstructure) with BMD measured by DXA, and microstructural parameters measured by     MicroMRI. As an exploratory aim we will investigate HR-MRI parameters of trabecular     microstructure obtained using a newly developed, rapid MRI sequence referred to as IDEAL-FSE     with parameters obtained using the currently available MicroMRI, Inc. sequence.   "
244498|NCT01055691|"     The primary objective of the study is to establish if the same amount of drug is absorbed     into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the     individual dapagliflozin tablet and individual metformin tablet.   "
244442|NCT01049282|"     The study has the following objectives:      Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine     administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective     To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in     different antigen/adjuvant formulations at 0 and 2 months.   "
244443|NCT01049295|"     The aim of this study is to assess the effects of n-3 fatty acids on taxane-induced     neuropathy and neurotoxic inflammatory agents in patients suffering from invasive breast     cancer.   "
244444|NCT01049308|"     We assessed the prevalence of cognitive/memory problems in veteran patients with heart     failure, and evaluated its relationship to medication compliance.   "
244445|NCT01049321|"     The investigators are not aware of any study regarding the effect of DASH eating pattern on     different cardiovascular risks among type 2 diabetic patients. The investigators assumed that     DASH eating pattern could reduce the cardio-metabolic risks and improve the hepatic function     among type 2 diabetes.   "
244446|NCT01049334|"     The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg     lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen     lozenge throughout the course of treating sore throat due to acute pharyngitis.   "
244447|NCT01049347|"     Activation of the hypothalamus-pituitary-adrenal system is monitored using saliva cortisol     sampling during the antidepressant treatment with amitriptyline and paroxetine in moderately     to severely depressed patients. Additionally, serum and plasma are sampled during the 5-week     study period in order to study endocrine and metabolic parameters.   "
244448|NCT01049360|"     The purpose of this study is to evaluate the efficacy of this multicenter, randomized,     double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study     comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or     with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID)     in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD)     beginning with a 2-week run-in period and with a 7-10 day washout each between treatment     period.   "
244449|NCT01049373|"     To evaluate superiority of HDC in comparison to placebo in the treatment of chronic low-back     pain in relation to pain, functional impairment, quality of life, and state of health during     a 15-week treatment period.   "
244450|NCT01049386|"     Rationale: Intestinal permeability of subjects can vary depending on their health status. It     is therefore important to be able to measure and quantify intestinal permeability in a     standardized way. Subjects with intestinal complaints (like irritable bowel disorder) or     obese subjects have been found to have increased intestinal permeability. Different     physiological conditions might affect intestinal permeability (IP) further.      In the clinic, sugar absorption tests and different blood and urine markers have been used to     quantify IP. The sugars sucrose, mannitol, sucralose and lactulose are absorbed differently     in the small or large intestines, resulting in different sugar levels in urine. This     indicates the level of intestinal permeability and the location of increased permeability     which is more or less permeable.      A high-fat meal could be used as a challenge test to increase IP in subjects even further.     After a high fat meal, lipopolysaccharide (LPS) could be co-transported with chylomicrons.     Small amounts of LPS co-transit with dietary fat from the gut after a high-fat meal, which     thereby increases plasma LPS concentrations.      Because of the above mentioned reasons, it could be relevant to determine intestinal     permeability and plasma LPS concentration after consumption of a high-fat diet.      Different methods will be used to determine the intestinal permeability in lean and obese     men, under different conditions. New parameters, like intestinal (I) fatty acid binding     protein (I-FABP), liver (L)-FABP, LPS and inflammatory markers will be measured and related     to outcomes of tests, to examine the relation with intestinal permeability.      The association of IP with whole body electrical resistance will be examined, to determine     usefulness of a candidate non-invasive method for IP investigation.   "
244451|NCT01049399|"     The purpose of this study is to determine wether NP031112 is safe and effective in the     treatment of mild to moderate Progressive Supranuclear Palsy   "
244453|NCT01049425|"     The planned trial compares an anthracycline-free taxane based regimen versus a modern third     generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The     aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to     a patient, who will only have a modest benefit from this compound. Prior to randomization for     chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to     identify patients who should not receive chemotherapy.      Secondary objectives of this trial will be to compare overall survival and toxicity between     the two chemotherapy arms, to evaluate survival in the observation arm and to perform     translational research regarding prognostic and predictive factors.   "
244454|NCT01049438|"     This clinical trial tests the hypothesis that body decolonization of patients with recurrent     community-associated (CA) MRSA infections will significantly reduce the likelihood of     recurrent CA-MRSA infection.   "
244455|NCT01049451|"     We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as     Acthar Gel® (MANUFACTURER NAME) is effective in the control of clinical disease activity as a     pulse therapy for relapsing-remitting MS when added to standard treatment with     beta-interferon.      We wish to determine whether ACTH, when administered as clustered monthly intramuscular     injections (monthly pulse therapy) as add-on to beta-interferons, may be a safe and effective     alternative to monthly pulse therapy with MP. In addition, we hypothesize that pulse therapy     with ACTH alters immune function to favor a regulatory, rather than a pro-inflammatory T cell     environment.   "
244456|NCT01049464|"     The purpose of this study is to determine the efficacy of Magnesium sulphate for the rate and     rhythm control of the new onset (within 48 hours) atrial fibrillation in the hemodynamically     unstable patients, admitted in the medical intensive care unit patients.   "
244457|NCT01049477|"     The purpose of the study is to determine if listening to your choice of music with a portable     mp3 player before and after a cesarean section for delivery of a baby will decrease the     patient's anxiety level.   "
244507|NCT01055808|"     This study is designed to address the gap in the literature related to changing treatment     regimen or formulation between different types of insulin, and how this change impacts     quality of life, adherence, individual patient treatment satisfaction and glycemic control.   "
244458|NCT01049490|"     Primary objective: To evaluate the safety and immunogenicity of low-dose ID S-OIV H1N1     vaccines delivered via a novel microneedle device (MicronJet600) and compare this to the     full-dose standard IM injection.      Hypothesis: Low dose (20%) intradermal (ID) S-OIV H1N1 vaccine delivered via a novel     microneedle device (MicronJet600) is equally effective as full-dose standard intramuscular     (IM) vaccine.   "
244459|NCT01049503|"     This study aims to assess the overall effect of pH and fluoride concentration of liquid     dentifrices in the control of children dental caries of a fluoridated area, through visual     inspection and the quantitative light-induced fluorescence (QLF) method. Toenail F     concentration of a subsample of the children enrolled will be evaluated, in order to assess F     bioavailability from these formulations and the evaluation of the concentration of fluoride     incorporated into the biofilm will be done 6 months after initiation of the dentifrices use.   "
244460|NCT01049516|"     The purpose of this study is 1) to evaluate whether massing 10 PE sessions in 2 weeks (massed     trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed     sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8     weeks (spaced trials; S-PE), and 3) to evaluate for the first time the efficacy of the 10 PE     sessions delivered in 8 weeks in an active duty population by comparing it to an active     comparison condition, Present-Centered Therapy (PCT).   "
244461|NCT01049529|"     The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration     attenuates the inflammatory cytokines and improve clinical outcomes in neonates who underwent     cardiovascular surgery   "
244462|NCT01049542|"     Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem     with a poor prognosis and the search for novel treatments remains an important area of     research.      Urocortins are proteins that appear to increase blood flow and heart pumping activity. There     has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in     heart failure.      In this study, we will examine the effects and mechanisms of Urocortins 2 & 3 and the     Corticotrophin Releasing Hormone Receptor Type 2 (CRH-R2) receptor (through which urocortins     act) on forearm blood flow and release of natural blood clot dissolving factors in the     forearm circulation of healthy volunteers.      In this study, we will look at the role of the lining of the blood vessel (endothelium) in     response to urocortin types 2 and 3. We hypothesise that urocortins 2 & 3 act via the     endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen     activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a     role in maintaining the normal baseline level of blood flow in forearm arteries. In addition     to the above, we will also look at the effect of temporarily blocking the effect of     urocortins, using a specially designed blocker drug (Astressin 2B).      Utilising the well-established technique of 'forearm venous occlusion plethysmography', we     will be able to focus on the local effects of urocortins on arterial blood flow in forearm     vessels, without affecting this system in the body as a whole.   "
244463|NCT01049555|"     Neuropsychiatric symptoms form part of the clinical picture of Alzheimer's disease (AD) and     other dementias. Irrespective of the severity of the disease, the most frequently encountered     symptom is apathy. Apathy is increasingly diagnosed in patients with neurological and     psychiatric conditions. Apathy is a disorder of motivation, defined as the direction,     intensity and persistence of goal-directed behaviour. Most of the current descriptions     acknowledge this point and consider apathy in terms of a lack of goal-directed behaviour,     cognition or emotion. The classical neuropsychiatric symptom assessments are subjective     structured interview-based, using input from the caregiver and/or the patient. New     technologies are likely to provide us with a more objective measure. An example is ambulatory     actigraphy, consisting of a piezoelectric accelerometer designed to record arm movement in     three dimensions.      The aim of the present study is to assess using actigraphy and video recording signal, AD     patients with (n = 15) and without (n = 15) apathy and control subjects (n = 5) during an     activity of daily living scenario .   "
244464|NCT01049568|"     This study will use a longitudinal, experimental design. Participants will be randomized to     either the intervention or the control group.      The intervention will involve cell phone support, including reminders, assessment of barriers     to adherence, problem solving and referrals conducted by an Adherence Facilitator.      Control group participants will participate in all on-study evaluations, except the     intervention exit interviews.   "
244465|NCT01049581|"     Aquatic intervention had been applied in children with neuromotor impairment for years, yet     there has been little progress toward objective identifications of therapy goals,     interventions, and outcomes. Thus, we attempt to design aquatic intervention activity for     children with cerebral palsy to evaluate the effect of hydrotherapy.      Purpose:      To evaluate the effects of pediatric aquatic therapy on motor performance, daily activity and     social participation in children with spastic cerebral palsy.      Method:      The study enrolled 27 children with spastic cerebral palsy aged from 4 to 12 years old.These     children were dived into two groups: traditional rehabilitation therapy (control group), and     hospital based pediatric aquatic therapy program. We evaluate the motor performance, daily     activity and social participation before and after the intervention and compared the     difference in improvement between groups. The measurements include modified Ashworth score,     Gross Motor Function Measure (GMFM -66), Vineland Adaptive Behavior Scale (VABS) , and     Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL).      Expect effect:      We suppose pediatric aquatic therapy in spastic cerebral palsy children could improve motor     function and daily activity.Children could improve self-esteem and we hypothesize this could     improve social participation.   "
244466|NCT01049594|"     Preterm infants face an uncertain future because premature birth often leads to problems with     brain development and can cause cerebral palsy.      A trial needs to be done to see if Magnetic Resonance Imaging (MRI) helps families and     professionals by predicting long term problems more accurately, allowing better targeting of     care to children with problems and reassuring the parents of normal babies.      This programme will provide the evidence-base for the National Health System (NHS) policy on     the use of magnetic resonance imaging of the brain for preterm infants.   "
244508|NCT01055821|"     The primary objective of this protocol is to study the effect of the standard of care in     hepatitis C (pegylated interferon and ribavirin) associated with therapeutic vaccine TG4040     on the viral load of treatment-naïve patients with chronic genotype 1 hepatitis C infection.   "
244467|NCT01049607|"     There is clinical uncertainty and ongoing discussion among liver surgeons regarding the     optimal method of parenchymal transection in patients undergoing elective hepatic resection.     While the clamp-crushing technique still represents the reference technique for routine liver     resections, transection of liver parenchyma using vascular staplers may offer a new and safe     technique potentially reducing intraoperative blood loss, operation time as well as     peri-operative morbidity. As morbidity of patients undergoing hepatic resection remains high,     approaches to lower peri-operative complications are urgently required. Due to the lack of     evidence it has to be evaluated, if the technique of stapler hepatectomy decreases     intraoperative blood loss as a highly relevant predictor of peri-operative complications,     patients' hospital stay and finally health care expenditures. These advantages would favor     stapler hepatectomy to be applied in routine liver resections. As RCTs are generally     considered to generate the most valid scientific evidence on a treatment's effects, the     present trial evaluates potential benefits of stapler hepatectomy in a randomized fashion.   "
244468|NCT01049620|"     It is expected that RAD001 works in gastric cancer by inhibiting PI3K/AKT/mTOR pathway and     Hif1A (hypoxia inducible factor 1, alpha subunit), a key player in angiogenesis and the     growth of tumors like renal cell carcinoma.However, RAD001 alone looks not enough to control     gastric cancer. By the mechanisms above, RAD001 can show additive or synergistic effect in     combination with conventional chemotherapy. In this study, XELOX was selected as a     conventional combination chemotherapy because it was proven very active and safe in gastric     cancer. Combination of XELOX and RAD001 has been never tried for the treatment of cancer     patients yet. So, the optimal dose will be first determined in this phase I study   "
244469|NCT01049633|"     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells     are destroyed, resulting in poor blood sugar control. The purpose of this study is to     determine the safety and effectiveness of islet transplantation, combined with     immunosuppressive medications and medications to support islet survival for treating type 1     diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic     episodes.   "
244470|NCT01049646|"     The apelin-APJ system is a relatively new discovery. It has generated interest in part due to     it's apparent ability to counteract the renin-angiotensin system, which is frequently     overactive in many cardiovascular disease.      Apelin improves that pumping ability of the heart and we wish to know if this action persists     in the presence of increased levels of angiotensin II.   "
244471|NCT01049659|"     The investigators have shown that Nice area, like most of France, remains an area of mild     iodine deficiency. The investigators want to assess the potential benefit of early iodine     supplementation during pregnancy in women with normal thyroid function on the     neuropsychological development of their children assessed at the age of two with the Bayley     test.   "
244472|NCT01049672|"     OBJECTIVES:      How does Alfentanil compare with the standard drug Diamorphine for subcutaneous analgesia in     the palliative care setting?      STUDY DESIGN:      An open-label pilot comparison between alfentanil and diamorphine for palliative care     patients who require subcutaneous opioids.   "
244473|NCT01049685|"     Retrospective longitudinal cohort study with 36 HIV naïve-treatment patients, who started     therapy with lopinavir/ritonavir or efavirenz (LPV/r or EFZ), follow-up of 36 months. Primary     endpoint: virological success (HIV RNA <50 copies/mL) in the first six months and at the end     of the study.   "
244474|NCT01049698|"     Aging is associated with declines in muscle strength, power, and overall functional ability     that lead to disability and loss of independence. Furthermore, the existing high prevalence     of obesity in the elderly is greatly exacerbating these aging-related declines in function.     To date, regular exercise, especially resistance exercise, is the only known treatment to     consistently improve muscle function and perhaps delay the onset of disability. However, not     all individuals experience the same magnitude of benefit from a given exercise stimulus, and     accumulating data show that obesity limits muscle adaptations to chronic exercise.Therefore,     the proposed study is designed to determine the effects of caloric restriction on     improvements in skeletal muscle function in response to RT.   "
244475|NCT01049711|"     To study the cost utility analysis of Erythropoietin (EPO) for maintaining the different     hemoglobin (Hb) target levels in anemic hemodialysis patient in routine clinical practice.   "
244476|NCT01049724|"     The purpose of this study is to measure tear lacritin and heparanase levels before and     following surgery using a minimal risk procedure to collect tears from patients undergoing     PRK or LASIK.   "
244478|NCT01049750|"     The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will     undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety     state)and SDS of Zung (self-rating depression scale)questionnaires. The investigators will     evaluate anthropometric and biochemical parameters, dysautonomic function index, IMT (Intima     Media Thickness) index, and fundus oculi examen. Furthermore, the investigators will perform     MNSI (Michigan Neuropathy Screening Instrument) and NDS (Neuropathy Disability     Score)questionnaires.   "
244479|NCT01049763|"     This study is planned to characterize the pharmacokinetic properties of oseltamivir and the     active product--oseltamivir carboxylate--in obesity in order to provide clinical guidance for     the optimum oseltamivir treatment regimens for severe influenza. It is also a prompt response     to a new era influenza plan along with recognition of growing numbers of obese persons.      The study findings will be available for a future management plan in dealing with this virus     that is transmitted easily from person to person and has shown substantial antigenic changes     over time.      The primary focus of statistical analysis is to verify the effect of obesity on     oseltamivir/oseltamivir carboxylate pharmacokinetics as measured by oseltamivir carboxylate     Cmax, AUC (0-12), AUC (0-24), C12, λz, and t1/2 and oseltamivir Cmax, AUC (0-12), and C12.   "
244487|NCT01049867|"     The aim of this study is to evaluate if the intracoronary infusion of autologous bone-marrow     derived CD133+ endothelial precursor cells is able to promote neovascularization and to     improve myocardial perfusion and contractility in patients with refractory coronary heart     disease, characterized by poor response to standard coronary interventions, severe impairment     of the quality of life, and poor prognosis.   "
244488|NCT01049880|"     This study is designed to determine the maximum tolerated dose of vitamin C when given with a     standard chemotherapy for people who have metastatic pancreatic cancer.   "
244480|NCT01049776|"     Lung Cancer is the most common cause of cancer death in the United States with an estimated     mortality in excess of 160,000, more than the combined mortality seen with prostate, breast,     colorectal cancers(1). Most patients with Lung Cancer have Non-Small Cell Lung Cancers(     NSCLC) and only 25-30% of patients with NSCLC (Non Small Cell Lung Cancer) have resectable     disease( Stage I or II) at the time of diagnosis.      The vast majority of patients with advanced NSCLC (Non Small Cell Lung Cancer) are not     curable and overall five year survival is 11%-14%1.      Chemotherapy is beneficial for patients with locally advanced and metastatic disease.     Numerous phase III studies have determined the superiority of systemic chemotherapy over best     supportive care. Platinum based chemotherapy has been widely accepted as the standard of care     for the initial treatment of advanced NSCLC.      However first line chemotherapy is modest at best. A randomized trial comparing four of the     most commonly used chemotherapy regimens in the United States not only failed to show a     clearly superior arm but also confirmed the dismal prognosis of these patients. The response     rate for all 1207 patients was 18.6% with a median survival of eight months and one year     survival of 33.5 % and a two year survival of 12%5. Clearly a different paradigm is needed     for the treatment of this disease.   "
244481|NCT01049789|"     This is a two-phase study that is designed to test a novel behavioral intervention to treat     depression in Human Immunodeficiency Virus (HIV) adolescents and young adults. Four     Adolescent Trials Network (ATN) sites will be assigned to either the Combination Cognitive     Behavioral Therapy and Medication Management (COMB) treatment group or the Treatment as Usual     (TAU) group.      Phase I involves pilot testing of a 24-week intervention consisting of Cognitive Behavioral     Therapy (CBT) and Medication Management (MM) manuals at sites assigned to the COMB treatment     group. Participants enrolled at TAU sites will receive treatment for depression that is     typical at that site, which may include medication management, psychosocial therapy, or a     combination of the two. Psychopharmacological and psychosocial interventions will not be     standardized and participants may receive any depression treatment recommended by the site     clinicians while on study. Study coordinators and site clinicians, regardless of group     assignment, will document depression symptoms and treatment regimens for all participants for     24 weeks. In addition, site staff and participants at COMB sites will participate in an exit     interview. The findings from these interviews will be used to revise both CBT and MM     intervention manuals at the end of Phase I.      Phase II is a feasibility study of the revised CBT and MM manuals. Phase II involves similar     procedures as Phase I; sites assigned to COMB will implement the revised CBT and MM manuals.     Participants at TAU sites will receive treatment for depression that is typical at that site.     As in Phase I, psychopharmacological and psychosocial interventions will not be standardized     and participants may receive any depression treatment recommended by the site clinicians     while on study. Depression symptoms and treatment regimens for all participants will be     documented for 24 weeks. Additionally, all Phase II participants will have 2 follow-up visits     at weeks 36 and 48. Again, site staff and participants at COMB sites will participate in an     exit interview. The findings from these interviews will be used to revise both CBT and MM     manuals at the end of Phase II.   "
244482|NCT01049802|"     This is a prospective randomized controlled feasibility study to determine whether navigation     guided repetitive transcranial magnetic stimulation (rTMS) to the healthy hemisphere in     patients with subacute stroke has a beneficial effect when given concurrently with     task-oriented motor rehabilitation of the arm and hand. Navigation guided rTMS requires a     structural MRI scan for targeting stimulation and therefore structural MRI will be performed     on all subjects. In addition the study intends to determine whether measures of motor tract     integrity (MTI) assessed by navigated brain stimulation (NBS) and MRI diffusion tensor     imaging can be used to clarify prognosis of motor recovery and to monitor progress with     rehabilitation. 30 subjects with ischemic or hemorrhagic stroke 3-9 months prior to     enrollment and with residual upper limb hemiplegia will be randomized to receive either 1 Hz     rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with     rehabilitation therapy or sham rTMS to the contralesional hemisphere for 30 minutes 3 times a     week for 6 weeks along with rehabilitation therapy. Primary outcome is improvement on the     Action Research Arm Test, a measure of arm and hand function in people with stroke. Outcomes     will be measured immediately post treatment, and at 3 months and 6 months post treatment.   "
244483|NCT01049815|"     Aims of the multi-center, randomized, treatment-controlled clinical trial are to compare the     efficacy of sevelamer hydrochloride to calcium-containing phosphorus binders in reducing the     rate of progression of femoral and carotid intimal media thickness (IMT) thickening as     measured by B-mode ultrasound in stable maintenance hemodialysis (HD) patients.   "
244484|NCT01049828|"     Tinnitus is the occurrence of an auditory sensation without the presence of an acoustic     stimulus. Approximately, 50 million people in the United States experience chronic tinnitus     and 15 million of these people have bothersome tinnitus. Several studies have shown that     people who are bothered by their tinnitus have difficulty in concentration and focus. Through     imaging modalities we have deranged neural networks responsible for attention. Only 20     percent of patients diagnosed with tinnitus are severely bothered. We seek the following:        1. Match a group of non-bothered tinnitus patients on age and hearing status to an existing          cohort of bothered tinnitus patients.        2. Assess the resting-state neural connectivity in patients with non-bothersome tinnitus.          Findings from the comparison of functional connectivity magnetic resonance imaging          (fcMRI) from subjects with bothersome tinnitus in our current rTMS clinical trial to          normal age-matched controls without tinnitus demonstrates that subjects with bothersome          tinnitus have dramatic alterations in cortical attention and control networks. Our          hypothesis is that the fcMRI-defined changes in the attention and control networks          reflect the impact of excessive auditory stimulation in patients with bothersome          tinnitus and explains the difficulty with concentration, short-term memory, and other          common problems. To fully test this hypothesis we need to obtain fcMRI of the attention          network among subjects with tinnitus but without bother and compare the status of their          neural networks with those of tinnitus subjects with bother and with normal controls.        3. Compare the resting cortical networks in subjects with non-bothersome tinnitus to          subjects with bothersome tinnitus and subjects without tinnitus Our null hypothesis is          that there are no differences in the resting-state cortical networks, especially the          attention and control networks, between tinnitus patients who do not experience bother,          tinnitus patients who do experience bother, and subjects without tinnitus. Through          fcMRI, we will examine correlations in blood oxygen level dependent (BOLD) signals in          established auditory, attention, control, and other brain regions in the resting brain          and compare these findings to already collected fcMRI scans of bothered tinnitus          patients, and controls (patients without tinnitus).   "
244517|NCT01055938|"     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,     crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with     Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fasting conditions.   "
244485|NCT01049841|"     The purpose of this study is to test the safety and effectiveness of 2 drugs, perifosine in     combination with temsirolimus in children with solid tumors. Neither drug is currently part     of the standard treatment of solid tumors in children. Both drugs have been tested alone to     treat solid tumors in children with little success. There is now new insight that if given     together, perifosine and temsirolimus may work together to stop the growth of solid tumors     and may also make them shrink. The doctor wants to find out what effects; good and/or bad,     perifosine in combination with temsirolimus has on the patient and the cancer. The doctors     are testing four different dose schedules of perifosine with temsirolimus and the patient     will be asked to partake in one of the dose schedules. The dose schedule will be lower for     those enrolled early in the study.   "
244486|NCT01049854|"     CD34+ stem cell selection in children, adolescents and young adults receiving partially     matched family donor or matched unrelated adult donor allogeneic bone marrow or peripheral     blood stem cell transplant will be safe and well tolerated and be associated with a low     incidence of serious (Grade III/IV) acute and chronic graft versus host disease (GVHD).   "
244489|NCT01049893|"     AC220 will be administered as a once daily oral solution given continuously as 28-day     treatment cycles, without food and without any rest periods, as long as there is no evidence     of disease progression or unacceptably severe adverse events (AEs) related to the study drug.   "
244492|NCT01049932|"     Pre-exposure prophylaxis (PrEP) is an experimental HIV-prevention strategy using     antiretroviral (ARV) agents to protect HIV negative individuals from HIV infection.TMC278 is     a new drug being developed for this type of HIV treatment. It is hoped that this drug may be     used to help prevent HIV transmission in future. A 'long acting' formulation of TMC278 has     been developed. Long acting means that the drug will be present in the blood for longer. It     is this formulation of the drug that will be investigated in this study. Subjects will     receive the drug by injection.      The purpose of this study is to investigate the safety of the drug and how well it is     tolerated by the body. The study will look at the levels of the study drug in the subjects     blood over the duration of the study.   "
244493|NCT01049945|"     RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Lenalidomide may stimulate the immune system in different ways     and stop cancer cells from growing. Giving bendamustine hydrochloride together with     lenalidomide and dexamethasone may kill more cancer cells. PURPOSE: This phase I/II trial is     studying the side effects and best dose of bendamustine hydrochloride and lenalidomide when     given together with dexamethasone and to see how well they work in treating patients with     relapsed multiple myeloma.   "
244494|NCT01049958|"     This study will examine the prevalence of patient-ventilator asynchrony and its determinants.     Mechanically ventilated trauma patients often experience asynchrony when their pattern of     breathing does not match the triggering of a mechanical ventilator.      Asynchrony is thought to be more common in delirious patients, patients with chronic lung     disease and those who are heavily sedated. The study will examine the relationship between     (1) delirium and sedation and (2) the prevalence of asynchrony in trauma patients.   "
244495|NCT01049971|"     Surgical site infection is common in colorectal surgery leading to increased postoperative     pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence,     reducing the wound infection rate is a major aim in abdominal surgery.      Wound protectors were invented for retracting the abdominal wall and keeping the abdominal     wall sterile in order to reduce bacterial colonialization of the wound and wound infections.      This is a prospective-randomized trial comparing use of wound protectors versus woven drapes     in laparoscopic colon resections with minilaparotomy.   "
244496|NCT01055665|"     The investigators are exploring the role of Cognitive Behavioral Therapy (CBT), a treatment     for depression, on self-efficacy (feeling empowered to accomplish a given task) and     depression in persons with chronic pain and depression. Past research has shown that persons     with chronic pain show improvement in self-efficacy and depression scores when they are using     CBT. The Pain rehabilitation Center (PRC) at Mayo Clinic is adding CBT focused groups to     better understand the role of CBT on self-efficacy and depression in persons with chronic     pain and depression.   "
244497|NCT01055678|"     The purpose of this pilot study is to determine the prevalence of markers of chronic and     cycling hypoxia and reactive species stress (oxidative and nitrosative) in the breast cancer     tumor microenvironment. The study is based around four cornerstone features of the pathologic     microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1     and VEGF, which we term the HRHV axis. Fifty breast cancer patients with planned surgical     excision will be administered the hypoxia marker drug, EF5, 24-36 hr prior to surgical     excision. EF5 is a non-therapeutic drug and provides no direct benefit to those patients     enrolled in this pilot study. Tissues obtained intra-operatively will be snap frozen and     subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of     immunohistochemical and urine markers that depict the HRHV axis will be examined. The     association of the markers with the presence of hypoxia, as determined by EF5 positivity,     will be determined. Data from this pilot study will be used to establish the prevalence of     markers of the HRHV axis in breast cancer. This information will be crucial for future human     trials in which the HRHV axis is therapeutically targeted.   "
244499|NCT01055704|"     This is a single-center, randomized, double blind, placebo-controlled study evaluating the     effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on     gastrointestinal motility and colonic transit of solids in healthy human subjects.      The hypotheses are:        1. Methylnaltrexone administered subcutaneously enhances gastrointestinal motility with          acceleration of overall colonic transit, and ascending colon emptying of solids in          healthy humans.        2. Methylnaltrexone significantly accelerates colonic transit that is delayed by codeine   "
244500|NCT01055717|"     This is a placebo-controlled, crossover study investigating the pharmacokinetic     bioavailability of avenanthramides from avenanthramide-enriched oats and their in vivo     metabolites in a cohort of healthy, older adults.   "
244501|NCT01055730|"     The purpose of this study is to determine if pulmonary rehabilitation has any effect on     breathlessness, quality of life, physical function and depression in persons with     interstitial lung disease.   "
244502|NCT01055743|"     This study will assess the clinical efficacy and safety of fluorouracil implants regional     chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma.   "
244503|NCT01055756|"     The primary objective of this study is to evaluate the clinical efficacy of the drug     Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin     D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic     rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and     laboratory (nasal flow) down through time.   "
244504|NCT01055769|"     The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral     Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used     to support Linezolid OS NDA in China.   "
244505|NCT01055782|"     The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with     or without endoguide.      The study will investigate whether the endoguide improves success rate and the patient's     perception of pain.   "
244506|NCT01055795|"     The main purpose of this study is to test the safety of three study drugs, bevacizumab     (Avastin™), Everolimus (Afinitor™) and LBH589 (Panobinostat) when they are given together. It     is hoped this study drug combination might lead to a greater decrease the in size of the     cancer and/or slow down how fast the cancer is growing compared to when these drugs are given     alone.      Subjects will be enrolled at Duke University Medical Center (DUMC).   "
244511|NCT01055860|"     Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce     in regard to its long-term outcomes. This advanced procedure is offered at MMH through the     Urogynecology division. The Investigators setup to review the one year outcome of patients     who underwent this procedure using a polypropylene mesh. These outcomes will include     anatomical and quality of life measures.   "
244512|NCT01055873|"     ANRS-EP38-IMMIP is a non interventional study. A single blood sample (30 mL) was drawn during     a hospital visit for clinical follow-up. Immunological assays were performed on fresh blood.     Cells and plasma were stored and kept frozen for additional biological evaluations.      Patients are included in the French perinatal cohort (ANRS CO-10), or have been followed     since before 1996 in the same clinical sites as patients who belong to ANRS CO-10. In the     ANRS CO-10 cohort, all patients are prospectively followed from birth.   "
244513|NCT01055886|"     The investigators propose to evaluate the relationship between PTSD, mood, craving and     withdrawal symptoms and factors associated with relapse in the context of a randomized     clinical smoking cessation trial. The use of supplemental nicotine administration (SNA)     during a pre-treatment phase before a targeted quit date is an innovative development in     smoking cessation, and may be helpful in treating smokers with PTSD. The use of SNA during ad     lib smoking for smokers with PTSD is predicted to reduce both the physiological and emotional     dependence on inhaled nicotine, thereby increasing the odds of successful smoking cessation.      Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions     (active patch versus placebo patch) for 2 weeks before a target quit-smoking date. All     participants will receive brief cognitive-behavioral therapy (CBT) and will begin standard     nicotine replacement therapy on their quit day. PTSD symptoms, mood, smoking craving and     withdrawal symptoms will be evaluated using electronic diary assessment for one week prior to     the pre-cessation period, during the 2-week pre-cessation period, and 6 weeks post quit date.     The study is designed to address the following aims:      Specific Aim 1: To examine the effects of SNA on PTSD symptoms, mood, craving and withdrawal     through electronic diary assessment.      Hypothesis 1.1. SNA will decrease craving for cigarettes during the 2 week pretreatment     period as compared to the placebo patch condition.      Hypothesis 1.2. SNA will decrease the perceived improvement in mood and PTSD symptoms     associated with smoking behavior.      Hypothesis 1.3. SNA during the pre-cessation period will result in a reduction of withdrawal     symptoms following the quit-date.      Specific Aim 2: To evaluate the effect of SNA on quit rates among smokers with PTSD.      Hypothesis 2. SNA during the pre-cessation period will result in improved quit rates Specific     Aim 3: To investigate potential predictors of relapse including PTSD symptom severity, mood,     anxiety sensitivity, distress tolerance, and self-efficacy.      Hypothesis 3.1 - 3.5 Increased PTSD symptom severity, increased baseline negative affect,     increased anxiety sensitivity, decreased distress tolerance, and lower self-efficacy each     will independently be associated with shorter abstinence from smoking.   "
244514|NCT01055899|"     This study will test the safety and tolerability (how the body reacts to the drug) of REGN88     and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid     Arthritis.   "
244515|NCT01055912|"     The purpose of this study is to evaluate the effects of oral lixivaptan capsules in patients     with congestive heart failure.   "
244516|NCT01055925|"     The almost single disadvantage of conventional polyurethane film dressings, an uncontrolled     leakage, is probably as often described as its numerous advantages for split-thickness skin     graft (STSG) donor sites. This shortcoming can be overcome by perforating the polyurethane     dressing (MPD), which permits a controlled leakage into a secondary absorbent dressing. The     study was conducted to compare the MPD-system and Aquacel® (ConvaTec), a hydrofiber wound     dressing, which also seems to fulfill all criteria of an ideal donor site dressing.   "
244518|NCT01055951|"     The purpose of this study is to assess the safety and usability of the Solo™ insulin     MicroPump in subjects with type 1 diabetes who are pump users.   "
244520|NCT01055977|"     Statins are the first choice treatment of dyslipidemia, a major contributor to cardiovascular     diseases. Statins also have enough evidence to demonstrate decrease of morbidity and     mortality from cardiovascular diseases. Even though statin therapy is effective treatment of     dyslipidaemia not all patients reach the goal levels.      The aim of the study is to estimate proportion of patients who achieved the therapeutic goal     (LDL-C. total cholesterol, HDL-C and triglycerides levels) after at least one year of a     statin therapy.   "
244521|NCT01055990|"     The 2009 flu pandemic is a global outbreak of a new strain of influenza A virus subtype H1N1,     commonly known as swine flu, that was first identified in April 2009. Large-scale     immunization is an essential approach of controlling the pandemic.Vaccines are now becoming     available for protection against pandemic influenza A(H1N1) 2009 infection in some     countries.In response to the pandemic, novel vaccines against the virus strain     A/California/07/2009(H1N1) have been developed and recently were approved for vaccination     among specific populations in China. However, the safety and effectiveness of the vaccines is     of prime concern to the authorities and the public.This report details the findings of a     observational clinical trial of the safety and immunogenicity of a influenza A (H1N1)2009     monovalent vaccine.      The virus of Swine Flu H1N1 that outbroke in 2009 is sensitive to neuraminidase inhibitors     (Oseltamivir, zanamivir and peramivir) but have drug resistant to adamantanamine derivatives     (amantadine and Flumadine), therefore neuraminidase inhibitors are recommended for antiviral     therapy against Swine Flu H1N1, effect of which is evidence by the data that such drugs do     modify the symptoms and decrease the death rate of H1N1 in America and Mexico. However,     clinically, the investigators have encountered that this virus can infect resistant strains     of Oseltamivir, which urges for a more effective treatment plan.      In view of above situations, seeking for an effective measures against H1N1 flu should be a     top priority and will benefit human life and economy globally. This Topic will take the     classic strategy of passive immunity to perform basic and clinical researches on applying     blood fix to treat critical H1N1 patients and collect blood of healthy persons who are     inoculated with specific H1N1 vaccines to cure critical H1N1 patients.   "
244522|NCT01056081|"     Uncertainty persists regarding the usefulness of incorporating inspiratory muscle training     (IMT) in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary     disease. In this study the investigators investigate whether IMT associated with exercise     training would be better than exercise training alone, with regard to exercise capacity,     inspiratory muscle strength and dyspnea.   "
244523|NCT01056094|"     Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased     interest in evaluating the effect of lutein for optimizing immune functions. A large number     of epidemiological studies support the notion that a high intake of lutein is associated with     a reduced risk of coronary heart disease and certain types of cancer. The biological     mechanisms for the protective effects of this carotenoid, including powerful modulation of     functions and antioxidant properties, are only partially known. Although several nutrients     and phytochemicals have been shown to modulate immune functions in humans, few studies have     investigated the role of lutein consumption. No information is available as to whether lutein     supplementation could be protective against oxidative stress. Therefore, the objective of the     present study was to examine the effect of consuming different doses of lutein on oxidative     stress in healthy subjects.   "
244524|NCT01056107|"     This trial will study the effects of an investigational (not FDA approved) medication,     ROSE-010, on the movement of food through the stomach, small intestine and colon in females     with constipation predominant irritable bowel syndrome (C-IBS).      The study hypothesis is that ROSE-010 will delay gastric emptying of solids and enhances     gastric accommodation without retarding colonic transit in female patients with C-IBS.   "
244526|NCT01056133|"     The purpose of this study is to determine the effect of Omega-3 Fish oil supplementation on     hepatic gene expression in patients with Non Alcoholic Steatohepatitis (NASH). In addition,     effects of fish oil on intestinal microbiota will be assessed.   "
244527|NCT01056146|"     The purpose of this study is to test an on-line intervention for families of young children     who have experienced moderate or severe traumatic brain injury (TBI). Previous interventions     were not designed to address the needs of young children with TBI, and feedback revealed a     desire for more examples and materials appropriate for families of younger children. This     project builds upon the investigators previous research by modifying the online intervention     content to address the needs of young children with TBI. The goal of this project is to     develop an intervention that will encourage positive parenting behaviors, improve child     behaviors, and reduce parent distress and burden following TBI. The investigators hypothesize     that the intervention group will exhibit more effective parenting skills as well as better     child functioning and lower levels of parental distress at follow-up than will the active     comparison group.   "
244528|NCT01056159|"     The study will measure the improvement in lung function in subjects with asthma after     inhaling from two inhalers, Albuterol in a dry powder inhaler and albuterol in an HFA     (hydrofluoroalkane), metered dose inhaler.   "
244529|NCT01056172|"     This study aim to evaluate the non-inferiority of sustained virologic response in     peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment     duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.   "
244530|NCT01056185|"     Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus,     this observational study was initiated to estimate rates of morbidity and mortality and to     examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as     surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza     A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes     and influenza B viruses. The current version of the protocol (released in August 2013)     further broadens the scope of this observational study. With the recognition that novel     respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory     Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health     importance, the objectives of this protocol have been expanded.   "
244531|NCT01056198|"     This study tests two different approaches to the removal of dead tissue from the surface of a     wound.   "
244597|NCT01057056|"     Background: The main goal of geriatric rehabilitation reconditioning following an acute     illness is rapid restoration of normal activity. Key elements are pain control, restoration     of bowel functions, sleep, appetite and general well-being, along side the physical activity.      Objective: To assess the effect of mind-body intervention as an adjunct to medical and     physical rehabilitation in geriatric patients.      Design: Prospective study Setting: University affiliated large city general hospital   "
244532|NCT01056211|"     Scars are a frequent reason of consultation in a dermatological clinic. Their cosmetic aspect     can play a key role in patient satisfaction and self-image.      Non ablative fractional infra-red laser treatment is a new concept in the laser field using     arrays of microscopic thermal damage patterns to stimulate a wound healing response. There     are different reports on the positive effect of these type of laser treatment in the     treatment of acne scarring, striae, rythides, hypopigmented and hypertrophic scars.      The low morbidity of the treatment and the lack of satisfying treatment regimes for different     types of scars makes it attractive to investigate the efficacy and safety of 4 treatment with     the 1540nm non ablative fractional laser in the treatment of scars.      Objectives:        -  To evaluate the efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional          laser handpiece ( Palomar Medical Technologies ) 1 and 3 month after the last laser          treatment for 3 different scar patient groups :             1. Patients with hypopigmented scars             2. Patients with hypertrophic scars             3. Patients with scars due to grafts and reconstructions in the head and neck region.        -  To evaluate the treatment related pain. on a categorical scale from 0-10        -  To evaluate the adverse effect of 1540nm fractional laser versus untreated control in          the 3 patient groups.      The study design is a prospective single blinded randomised within-patient controlled study     The study involves 6 visits.   "
244533|NCT01056224|"     Skull pin insertion during craniotomies is a brief, intensely stimulating, painful stimuli     occurring during the conduct of a neurosurgical or spine anesthetic. Remifentanil is an ultra     short acting opioid that has been successfully used to blunt hemodynamic responses in a wide     variety of clinical scenarios. It is our intention to ascertain the optimal dose for blunting     the hemodynamic response to skull pin insertion using remifentanil.   "
244534|NCT01056237|"     An multi-site, randomized, prospective study to compare the efficacy and safety of     multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza     therapy.   "
244535|NCT01056250|"     Single Incision Laparoscopic Surgery (SILS) can be performed for different standard     operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy     sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to     identify and preserve relevant structures. The investigators want to evaluate feasibility of     performing cholangiography during SILS cholecystectomy.   "
244536|NCT01056263|"     The primary objective of this observational study is to retrospectively collect current     survival data for patients originally included in axitinib A4061012 [NCT00076011] study to     estimate the 5-year survival rate in subjects with metastatic renal cancer cell treated with     axitinib.   "
244537|NCT01056276|"     In this study, investigators will evaluate the activity of bendamustine, bortezomib and     dexamethasone (BBD). This regimen combines 3 agents with high activity in multiple myeloma,     with different mechanisms of action and non-overlapping toxicities.   "
244538|NCT01056289|"     Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated     for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation     (DVS SR)   "
244539|NCT01056302|"     This study proposes to develop a computer-based software tool that will allow surgeons to     plan and simulate surgery for patients with jaw trauma.   "
244540|NCT01056315|"     This trial is assessing the analgesic efficacy and safety of a new central analgesic in     subjects with pain due to diabetic peripheral neuropathy (DPN).   "
244542|NCT01056341|"     There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a     good benefit/risk profile. Based on the recent findings of encouraging results obtained with     propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is     expected to be of significant benefit in the management of the condition. The present study     has been designed to confirm efficacy of propranolol in severe IH by demonstrating     superiority over placebo and to document the safety profile of propranolol in this     indication.   "
244543|NCT01056354|"     Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus,     this observational study was initiated to describe participants seeking medical care in     geographically diverse locations with 2009 H1N1 infection and their clinical course over a     14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus     was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was     expanded to include other influenza A subtypes and influenza B viruses. This version of the     protocol further broadens the scope of this observational study. With the recognition that     novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory     Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health     importance, the objectives of this protocol have been expanded   "
244544|NCT01056367|"     The risk of cardiovascular disease (CVD) in patients with type-II-diabetes mellitus     (type-II-DM)is more than doubled and CVD accounts for 70% of deaths in this group of     patients.      Hypertension is a major risk factor for CVD in patients with type-II-DM and a major     contributor cardiovascular mortality. Uncontrolled- (UH) and resistant hypertension (RH)are     more common in patients with type-II-DM, why further bloodpressure (BP) control is needed.      The prevalence of UH and RH has not been examined in a consecutive Danish outpatient     population with type-II-DM.      The purpose of this study is to examine the prevalence of resistant hypertension in patients     with type-II-diabetes and to examine the characteristics of patients with resistant     hypertension as compared to patients with controlled hypertension with regards to arterial     stiffness.   "
244545|NCT01056380|"     This is a randomized clinical trial designed to evaluate oral nitazoxanide compared to a     placebo in the treatment of acute uncomplicated influenza in adults. We hypothesize that     treatment with nitazoxanide will reduce the duration of symptoms in patients with confirmed     influenza infection. Secondarily, we hypothesize that treatment with nitazoxanide will reduce     the complications of influenza, severity of symptoms, time lost from work, time to return to     normal daily activities, and viral shedding.   "
244598|NCT01057069|"     This study aims to compare the response of triple-negative breast cancer with deficient     homologous recombination to intensified alkylating chemotherapy versus standard chemotherapy     with dose dense AC and/or Docetaxel-Capecitabine.   "
244546|NCT01056393|"     This protocol serves to extend the successful treatment for HIV positive patients beyond the     endpoints provided by the Phase 2b TaiMed Biologics-sponsored protocol TMB202 (entitled A     Phase 2b Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab     Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected with HIV-1     (Amended to 24 Week Study)), for 24 weeks. Ibalizumab may be administered beyond 24 weeks     under this protocol as supply permits and patients continue to demonstrate virologic     response.   "
244547|NCT01056406|"     The purpose of this study is to determine if twice monthly interaction with a registered     dietitian from 6-16 weeks gestation through 6 months postpartum will help women who are     overweight or obese gain weight during pregnancy closer to the Institute of Medicine     (IOM)guidelines and lose weight more effectively within the 6 month postpartum period than     those who do not receive twice monthly interaction with a registered dietitian during this     period.      Overweight/obesity can lead to a number of adverse pregnancy, delivery and birth outcomes,     including increased risk of hypertension, eclampsia, and diabetes during pregnancy,     miscarriage, premature delivery, birth injuries, neural tube defects, and prenatal death.     More than half of women of childbearing age are overweight or are obese. Women of color and     low-income women are affected disproportionately.      Unfortunately, women know little, if anything, about the impact of overweight and obesity on     pregnancy and health care providers are unsure how to effectively address the problem with     their patients.      A limited number of programs have tested ways to effectively address weight gain management     during pregnancy. None have been successful in addressing weight gain in women who are obese     or overweight at the start of pregnancy. The 2-year Revere Health Center Pregnancy Weight     Management Study will test the feasibility and efficacy of providing pregnant women who are     overweight or obese with regular access to a registered dietitian during and after pregnancy     to help achieve total weight gain closer to recommended guidelines and to ensure the best     outcomes for the mother and her newborn.   "
244548|NCT01056419|"     The relationship between the method of the treatment of hyperthyroidism due to Graves'     disease and the course of Graves' ophthalmopathy is debated. The investigators aimed to     compare the results of total thyroidectomy done in 6 months following the appearance of the     symptoms of ophthalmopathy and the antithyroid drug therapy in patients with moderate to     severe Graves' ophthalmopathy.      The inclusion criteria: 1)Hyperthyroidism and moderate to severe Graves' ophthalmopathy     within 6 months, 2)Thyroid volumes greater than or equal to 15 mL in thyroid ultrasonography,     3)Patients taking no treatment except local medications for Graves' ophthalmopathy,     4)Clinical activity score of 3/7 or more, proptosis greater than or equal to 21 mm in one eye     or 2 mm difference between two eyes, presence of diplopia, the opening of the eye lid greater     than or equal to 9 mm.      All patients will be treated with antithyroid drug until TSH levels of the patients are     between 0.4-1. During this period all the patients will take pulse methyl prednisolone     treatment of a total dose of 4.5 gr. After pulse steroid treatment the patients will be     randomised to two groups: one group will be sent to surgery for total thyroidectomy, and     their TSH levels will be kept between 0.4-1 with levothyroxine treatment; the other group     will be followed under antithyroid drug treatment and their TSH levels will be kept between     0.4-1 also.      The smoking habits will be asked. Serum TSH, fT4 levels, Hertelmeter and eye lid opening     measurements, clinical activity scores, diplopia will be evaluated monthly; TSH receptor     antibody, anti-thyroid peroxidase and anti-thyroglobulin levels will be measured in 3 months     intervals for a period of 12 months.   "
244549|NCT01056432|"     The aim of this clinical study using Bone UltraSonic Scanner (BUSS) is to obtain clinical     data which will help to optimize the BUSS examination procedure and its diagnostic algorithms     for assessment of bone conditions.   "
244550|NCT01056445|"     Hemodynamic instability was controlled in 27 patient during carotid stenting and it was     showed that hemodynamic instability can be predicted by Valsalva maneuver before stenting and     hemodynamic instability have no prognostic effect on result of carotid stenting.   "
244551|NCT01056458|"     This study is expected to show auricular acupressure therapy help to improve the anxiety     symptoms of perimenopausal and early postmenopausal women, looking forward to developing a     convenient, safe and effective way to reduce the use of sedative hypnotics and their     dependencies, thereby improving their quality of life.   "
244552|NCT01056471|"     The main purpose of this study is to evaluate the safety and feasibility of regenerative     therapy with mesenchymal stem cells from adipose tissue, administered intravenously in     patients with secondary progressive multiple sclerosis who do not respond to treatment.   "
244553|NCT01056484|"     The purpose of this 52-week clinical trial is to see if the meditation-based intervention,     adjunctive to standard of care therapy, can reduce relapse and improve psychological health     among adults recovering from alcohol dependence.   "
244554|NCT01056497|"     Chronically elevated free fatty acids impair insulin sensitivity and insulin secretion (ie     lipotoxicity) by a combination of oxidative stress, endoplasmic reticulum (ER) stress and     inflammation. This study will test whether alpha-lipoic acid, which has potent antioxidant     and anti-inflammatory properties, prevents or ameliorates lipotoxicity.   "
244555|NCT01056510|"     This randomized, open-label, parallel group study will assess the effect on response rate and     the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic     lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A)     MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as     first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera     plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive     up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is     6-12 months, and target sample size is 600-700 individuals.   "
244556|NCT01056523|"     The purpose of the study is to determine the maximum tolerated dose of ribavirin, when given     in combination with low-dose ara-C and to determine if it is safe and well-tolerated in     patients with acute myeloid leukemia.   "
244557|NCT01056536|"     The objective of this study is to assess the impact of a structured intervention and/or free     distribution of condoms during the pre-travel consultation on sexual risk behavior of young     persons traveling alone.   "
244559|NCT01056562|"     The male sex-hormone called testosterone is known to play a key role in the growth of     prostate cancer. The usual treatment for the disease involves suppression of hormones     (testosterone) by anti-hormonal treatment for an unknown period of time until the cancer     progresses. This anti-hormonal treatment usually consists of injections every three months     with an LHRH(Leutinizing Hormone-Releasing Hormone) agonist and a short course of     anti-androgen pills, which together help to lower the production of testosterone. Long-term     hormonal treatment has potentially serious side effects and is expensive.      In this study, hormonal treatments will be with held from those patients eligible and willing     to participate. The aim of this study is to see if we can decrease the amount of hormone     injections that patients require. This might lead to a decreased side effects(such as     decrease in bone health, cardiovascular problems and metabolic syndrome which occurs when     several health conditions happen at the same time and can lead to an increased risk of heart     disease, stroke and diabetes) as well as to decrease the cost of hormonal therapy to treat     prostate cancer.   "
244560|NCT01056575|"     This will be an open label, sequential study of midazolam (dose 5 mg orally) followed by     midazolam (5 mg orally) given after dosing with OC000459 100 mg twice daily for 6.5 days.     Twenty subjects will be included to ensure at least 16 subjects with analysable PK data. PK     sampling for midazolam and 4-hydroxymidazolam plasma concentrations will continue for up to     and including 24 hours after dosing with midazolam on both occasions.   "
244561|NCT01056588|"     The primary objective of this research is to evaluate the effectiveness of this type of     smoking cessation program by comparing a treatment group with a control group.      A secondary objective of this research is to explore relations between impulsive behavior and     smoking-cessation success among treatment-seeking teens participating in a quit-smoking     program.      Hypothesis 1. A greater proportion of the participants in the treatment condition will be     verified as abstinent from smoking during the course of treatment than participants of the     control condition.      Hypothesis 2. It is hypothesized that teens who do not successfully stop smoking (or who drop     out of the treatment program) will be more impulsive (from measures taken just prior to     treatment) than those who do successfully stop or significantly reduce rate of smoking.   "
244562|NCT01056601|"     Cancer results from multiple mutations which cause cells to grow uncontrolled. It therefore     may be necessary to inhibit several oncogenic targets to affect cancer cell growth. Studies     have shown that panobinostat (LH589) causes a wide range of effect on endothelial cells that     lead to inhibition of tumor angiogenesis (a fundamental step in the transition of tumors from     a dormant state to a malignant one). Bortezomib triggers cell death in pancreatic cancer     cells but the mechanism is not well defined but has been determined to be cytostatic.     Combining these two drugs may work together in the treatment of pancreatic cancer.   "
244563|NCT01056614|"     This phase II trial is studying the side effects and how well giving fludarabine phosphate,     busulfan, anti-thymocyte globulin followed by donor peripheral blood stem cell transplant,     tacrolimus, and methotrexate works in treating patients with myeloid malignancies. Giving     chemotherapy, such as fludarabine phosphate and busulfan, before a donor peripheral blood     stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor     can make an immune response against the body's normal cells. Giving anti-thymocyte globulin     before transplant and tacrolimus and methotrexate after transplant may stop this from     happening.   "
244564|NCT01056627|"     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,     crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with     Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fed conditions.   "
244565|NCT01056640|"     Background: Older adults with multiple chronic illnesses are at risk for worsening functional     and medical status with ensuing hospitalization. One goal of medical care is to prevent this     decline. One method that may help slow this functional and medical decline is home     telemonitoring.      Specific aim: To determine the effectiveness of home telemonitoring compared to usual care in     reducing combined outcomes of hospitalization and emergency room visits in an at risk     population over 60 years of age.      Materials and Methods: This will be a randomized trial of 200 patients into one of two     interventions. Home telemonitoring involves the use of a computer device at home which     records biometric and symptom data from patients. This information is monitored by mid level     providers associated with the primary care medical practice. Usual care involves patients who     make appointments with their providers as problems arise and utilize ongoing support like a     24 hours nurse line. The study participants are adults over 60 years of age within the     highest 10% on elderly risk assessment (ERA) scores. Patients will have initial evaluations     of gait, quality of life (SF12), Kokmen test of mental status, and PHQ 9. Patients will be     followed for 1 year for primary outcomes of hospitalizations and emergency room visits.     Secondary analysis will include quality of life, compliance with the device and attitudes     about telemonitoring. Sample size is based upon an 80% power to detect a 36% difference     between the groups. The primary analysis will involve Cox proportional time to event analysis     comparing both interventions for telemonitoring or usual care. Secondary analysis will use     T-test comparisons for continuous variables (quality of life, attitudes) and chi square for     proportional analysis.   "
244566|NCT01056653|"     The purpose of this study is to test an educational intervention for first-time fathers of     late preterm (34 to 36 weeks gestation) infants.   "
244567|NCT01056666|"     The objective of this investigation is to asses with validated scales, the impact on the     quality of life of men suffering of moderate to severe incontinence of the use of Conveen     Optima urisheath in comparison with their usual absorbent protection.   "
244568|NCT01056679|"     The purpose of this study is to determine within the scope of the trial what the maximum     tolerated dose (MTD) of lenalidomide in combination with AVD should be.   "
244569|NCT01056692|"     OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients     with asthma. This clinical trial, in mildly asthmatic patients, studies the effects of     OC000459 and placebo on the asthmatic response to two known stimulants of the asthmatic     response in the lungs, namely cat hair, pollen or house dust mite and methacholine.   "
244571|NCT01056718|"     The goal of this pilot study is to effectively treat hypertension in subjects with either     known or newly diagnosed hypertension and concurrent evidence of diastolic dysfunction. Due     to the unique properties of nebivolol, it is hypothesized that there will be improvements in     left ventricular (LV) systolic and diastolic function manifesting as increase exercise     capacity in this patient population with primarily LV diastolic dysfunction. The present     study was performed to determine the effects of nebivolol on blood pressure, exercise     tolerance and parameters of left ventricular systolic and diastolic function in a group of     hypertensive patients with echocardiographic evidence diastolic dysfunction.   "
244572|NCT01056731|"     This is an open-label, not controlled, sequential, dose escalation study of 16 weeks'     duration. The study is composed of two periods: a 0-2 week optional wash-out period depending     on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment     period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with     Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25     if control of BP is not achieved (< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All     patients who have reached their BP target will be considered as having met the primary     endpoint and this visit will be considered as the final visit.   "
244573|NCT01056744|"     Background:      Safety concerns regarding use of drug eluting stent systems (DES) are related mostly to late     stent thrombosis, which is facilitated by incomplete stent endothelial coverage. Specific     information about time course and amount of endothelial strut coverage of different DES is     required, in order to further refine the concept of antiplatelet therapy after DES     implantation. Optical coherence tomography (OCT) is emerging as a new gold standard for     endovascular imaging of stents, atherosclerosis progression, vulnerable plaque and neointimal     proliferation. Very limited OCT data about endothelial coverage of DES are currently     available. Aim of this study is a comparative evaluation of XIENCE V® everolimus eluting     stent (Abbot Vascular) and of the bare metal stent (BMS) Coroflex® Blue postdilated with the     drug-eluting balloon (DEB) SeQuent® Please (paclitaxel-eluting balloon, B. Braun Melsungen     AG) in terms of endothelial coverage and neointimal proliferation using OCT.      Study Design:      A number of 80 patients scheduled for elective percutaneous coronary intervention (PCI) with     a native coronary stenosis suitable for DES implantation and OCT imaging are openly     randomized 1:1 to either XIENCE V® or Coroflex® Blue/Sequent® Please. The study is     prospectively conducted at a university high-volume PCI center with OCT expertise (Jena,     Germany). Angiographic follow-up and OCT imaging with motorized pull-back at 1 mm/s are     planned in all patients 6 months after implantation of the study stents. OCT endpoints are:     (1) endothelial coverage, expressed as % of struts without coverage and % of stent length     containing non-covered struts, and respectively (2) neointimal proliferation, given as %     neointimal volumetric proliferation within the whole stent and also as focal peak %     neointimal area proliferation. The study is not powered for clinical endpoints, which are:     subacute or late stent thrombosis and need for revascularization of the stent segment. Given     the high number of measurements (15 cross-section images / 1 mm stent length), OCT endpoints     are likely to reach significance at the level P < 0.05 even at a follow-up drop-out rate up     to 20%.   "
244574|NCT01056757|"     The purpose of this study is to learn whether oral Ribavirin is safe and effective in     treating patients with metastatic breast cancer, that have high levels of eIF4E.   "
244575|NCT01056770|"     The currently available stock of smallpox vaccine would be insufficient in the face of an     incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are     urgently needed because previous manufacturing methods using calf lymph are no longer     acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea     has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by     infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity,     and immunogenicity of CJ-50300.   "
244576|NCT01056783|"     This will be a randomised, double blind, placebo controlled, parallel group evaluation of the     effect of OC000459 given orally for eight weeks on active eosinophilic esophagitis.   "
244577|NCT01056796|"     The purpose of this study is:      Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27)     device for creation of circular, colorectal anastomoses in previously radiated patients.   "
244578|NCT01056809|"     For patients with primarily generalized colorectal cancer two treatment strategies are     compared to establish which strategy gives best overall survival.      The traditional strategy is to first resect the primary colorectal tumour and then treat the     metastases with chemotherapy followed if possible by surgery.      The alternative strategy is to first treat the metastases with chemotherapy followed if     possible by surgery and only resect the primary colorectal tumour if there is hope for cure     or if symptoms develop that necessitates treatment.   "
244579|NCT01056822|"     Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate     sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate mofetil (MMF) Leading to a     Dose Reduction of Tacrolimus. Maximiza Study.   "
244580|NCT01056835|"     The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the     development of chronic allograft nephropathy and changes in allograft function in prevalent     renal transplant recipients   "
244581|NCT01056848|"     To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects     with euvolemic and hypervolemic hyponatremia   "
244582|NCT01056861|"     Botulinum toxin injection in the contracting muscles has proven to be a safe and effective     method of relieving pain and lessening dystonic posturing. The current hypothesis is that     botulinum toxin works on altering sensory input in the central nervous system in addition to     its effects on the neuromuscular junction.      Magnetoencephalography (MEG)of brain has been used in dystonia such as writer's cramp and     musician's hand dystonia. However, no study has investigated the correlation of central     signal changes via magnetoencephalography before and after treatment with botulinum in     torticollis patients. Prior studies using somatosensory potentials indicated the possibility     of differential activation of precentral cortex in patients with cervical dystonia. Cervical     dystonia may result from a disorder of both cortical excitability and intracortical     inhibition. The investigators hypothesis is that botulinum injection modulates central     inhibition which improves clinical outcome for torticollis.   "
244583|NCT01056874|"     This is an open labelled study to estimate the effect of maraviroc on the pharmacokinetics of     digoxin, a probe for p-glycoprotein.   "
244599|NCT01057082|"     The purpose of this study is to determine whether older adults (ages 65-89) who consume the     dietary supplement Juven (Abbott Laboratories) versus placebo for 6 months will demonstrate     increases in fat-free mass, muscle volume,and physical function.   "
244600|NCT01057095|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is looking at gene expression in tissue samples from patients     with acute myeloid leukemia.   "
244584|NCT01056887|"     The differential diagnosis of patients with polyuria/ polydipsia is often complex, but     important for the therapeutic strategy.      Challenging is in particular the clinical differentiation between patients with a partial     Diabetes insipidus centralis and patients with primary polydipsia as underlying disease,     because both groups are associated with similar urinary osmolalities.      The determination of plasma arginine vasopressin is unusual in this context, since     measurement of AVP is not reliably.      C-terminal ProVasopressin (copeptin) is secreted stoichiometrically with AVP from the     neurohypophysis, but has a longer half life in the circulation, and is thus easier to     measure.      Therefore, the investigators will analyze in that study the diagnostic utility of plasma     copeptin in the differential diagnosis of polyuria and polydipsia.   "
244585|NCT01056900|"     This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron     transplantation by tracking subjects who had the Chondron implantation to observe     effectiveness.   "
244586|NCT01056913|"     After resection of diseased segments of the large intestine, the continuity of the intestine     has to be restored. This can be done by suturing or with so called stapling devices. In     addition since 2 centuries compression rings are used to connect the intestine after     resection. The NITICAR27 device is a novel compression anastomosis device. The investigators     want to prove if this novel device can be compared to commonly used stapling devices     concerning anastomotic leakage, bleeding and stenosis.   "
244587|NCT01056926|"     In the present study the investigators will measure the effects of nicotine and non-nicotine     factors on brain function during cognitive processes that are differentially sensitive to     these factors. One process—continuous working memory (CWM)—is implemented via a network of     frontal and parietal brain regions and is highly dopamine dependent. Smoking cessation     results in significant deficits in CWM which can persist for weeks and are reversed by     resumption of nicotine administration in the form of smoking or nicotine replacement.     Additionally, CWM deficits are observed during smoking of denic cigarettes. Brain function     during CWM is modulated by smoking abstinence and subsequent nicotine administration and     activity in the dlPFC is implicated in these effects. Collectively, these data suggest that     CWM is highly sensitive to the nicotine, but not non-nicotine components of smoking. Brain     function during CWM is altered by smoking abstinence and nicotine, but the effect of smoking,     in the absence of nicotine, has not been evaluated.      Another process—cue-reactivity (CR)—results from the repeated pairing of otherwise neutral     stimuli with nicotine administration. Acute smoking cessation has not been shown to have     strong effects on CR in the form of cue-provoked craving, nor has nicotine replacement been     shown to have robust effects on CR. Likewise, the direct effects of smoking abstinence on     brain CR have been small; though craving has been shown to modulate relations between     abstinence and CR. Moreover, recent data from our lab suggest larger 'doses' of abstinence (~     24 hrs) may amplify brain responses to cues. The effect of smoking in the absence of     nicotine, on CR has not, to our knowledge, been evaluated. Collectively, these data suggest     that CR in the form of cue-induced craving is not highly sensitive to the effects of     short-term smoking abstinence or nicotine. Brain CR is modulated by abstinence-induced     craving and longer-term abstinence, but it is unclear whether abstinence from nicotine or     non-nicotine components is responsible for these effects.      In the present study, we propose to evaluate the effects of non-nicotine and nicotine factors     on CWM and CR using functional magnetic resonance imaging. This method allows for the     non-invasive assessment of brain function. We will also examine the role of genes in     moderating and mediating the effects of nicotine and non-nicotine factors on cognitive     function   "
244588|NCT01056939|"     The purpose of this study is to find out if NAVA-technology is better in detecting patients     own inspiratory efforts during mechanical ventilation than currently used flow-triggering in     PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for     patients or not.      The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration     more accurately than currently used methods, and thus will lead to more smooth adaptation to     mechanical ventilation in pediatric patients. The investigators expect this to decrease the     time of ventilatory support needed.   "
244589|NCT01056952|"     The aim of the study is to assess, in patients with acute hypoxemic respiratory failure, the     short term physiologic effects of the high flow oxygen nasal therapy (Optiflow), in term of     inspiratory muscle effort, gas exchange, comfort and dyspnea   "
244590|NCT01056965|"     The primary objective of the study is to obtain preliminary safety and tolerability data with     davunetide (NAP, AL-108) in patients with a tauopathy (frontotemporal lobar degeneration     [FTLD] with predicted tau pathology, corticobasal degeneration syndrome [CBS] or progressive     supranuclear palsy [PSP]). The secondary objectives of this study are to obtain preliminary     data on short term changes (at 12 weeks) in a variety of clinical, functional and biomarker     measurements from baseline, including cerebrospinal fluid (CSF) tau levels, eye movements,     and brain MRI measurements.   "
244591|NCT01056978|"     Even if most patients in palliative care units presented with well-recognized risks factors     of venous thromboembolism (VTE) (eg: active cancer, bed rest, previous history of venous     thrombosis), the incidence of VTE in palliative setting is unknown. By consequence, the     efficacy and safety of antithrombotic prophylaxis in such a population is not established.     Indeed, patients admitted in palliative care units were not included in trials evaluating the     potential effect of antithrombotic drugs in regard to their poor prognosis at short term. In     addition, the main role of prophylaxis is to prevent sudden death from pulmonary emboli and     is thus a life prolonging therapy which is viewed as counterintuitive to palliative care     philosophy and inappropriate on grounds of futility. Nevertheless, the current use of Low     Molecular Weight Heparin in palliative care units seems to increase particularly in patients     with advanced malignancy. The identification of high hemorrhagic risks in palliative care     patients could help the decision of antithrombotic prophylaxis initiation. For this, the     investigators conducted a multicenter prospective longitudinal study.   "
244592|NCT01056991|"     This study will determine if modern under-patient warming mattresses are as effective as     forced air warming blankets in preventing cold and shivering in patients scheduled for non     emergency surgery.   "
244593|NCT01057004|"     EVITA should function as an idea supplier and should coordinate possible future studies.     Other important tasks of the register are: (i) the establishment of recommendations for an     optimal medicinal therapy (OMT) as well as for ICD- and CRT-treatment; (ii) the establishment     of quality assurance measures, including monitoring of new therapy.   "
244594|NCT01057017|"     Bevacizumab given at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease     progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease     progression.Primary Objective: To determine the safety of every 3 week panitumumab and     bevacizumab as maintenance therapy for patients with metastatic colorectal cancer.   "
244595|NCT01057030|"     The purpose of this study is to assess the safety and tolerability of multiple oral daily     doses of BMS-708163 in healthy young male subjects   "
244596|NCT01057043|"     The purpose of this exploratory randomised trial is to study the effect of pulsatile cupping     in osteoarthritis of the knee compared to waiting list control.   "
244676|NCT01058096|"     The objective of this study is to evaluate the efficacy, safety, and tolerability of     cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes     associated with bipolar I disorder.   "
244601|NCT01057108|"     The phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that     a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce     serum levels of phosphorus in patients with chronic kidney disease. We are testing this     hypothesis using a chewing gum called FOSTRAP which has been shown to be effective in a     small, non-randomized study in patients with chronic kidney disease on hemodialysis.   "
244602|NCT01057121|"     This phase I/II trial studies the side effects and best dose of lenalidomide and to see how     well it works in treating patients with acquired immunodeficiency syndrome (AIDS)-related     Kaposi sarcoma (KS). Lenalidomide may stop the growth of tumor cells by blocking blood flow     to the tumor.   "
244603|NCT01057147|"     The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to     placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye     disease.   "
244604|NCT01057160|"     This is a multicentre, open label, prospective, randomized, two-attack study with active     comparator in patients reporting inadequate response to analgesics and/or triptans to examine     the efficacy of Rizatriptan 10 mg RPD in this group of patients.   "
244605|NCT01057173|"     A randomized clinical trial of transcatheter aortic valve implantation (TAVI) versus     conventional surgical aortic valve replacement (SAVR) in patients older than 70 years of age     suffering from severe aortic valve stenosis.      Study hypothesis: TAVI will reduce post-interventional morbidity and mortality compared to     SAVR.   "
244606|NCT01057186|"     The purpose of the study is to do a follow-up survey of all individuals with hereditary     hypophosphatemia in Norway, focusing on manifestations in childhood and adolescence. The     investigators also want to study phenotype-genotype associations, and look for new genes, in     all forms of hereditary hypo and hyperphosphatemia.   "
244607|NCT01057199|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is looking at biomarkers in cell samples from patients with     acute myeloid leukemia.   "
244608|NCT01057212|"     This is a non-randomized, open-label, single arm phase II trial of the combination of     bevacizumab and ixabepilone in patients with advanced- or metastatic non-squamous NSCLC     progressive after first or second-line therapy. The main objective is to evaluate the     progression-free survival in patients with advanced or metastatic non-squamous NSCLC being     treated with ixabepilone and bevacizumab.   "
244609|NCT01057225|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking     blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and     thalidomide may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when     given together with cyclophosphamide, thalidomide, and dexamethasone in treating patients     with newly diagnosed active multiple myeloma.   "
244610|NCT01057238|"     This study was a trial of a formal system of family meetings to support family decision     makers of chronically critically ill patients in the intensive care unit.   "
244612|NCT01057264|"     The goal of this clinical research study is to find the highest tolerable dose of Abraxane®     (nab-paclitaxel) when given directly into the liver, in combination with Gemzar®     (gemcitabine) and Avastin® (bevacizumab) when given by vein.   "
244613|NCT01057277|"     The purpose of this study is to determine if RAD001, to a maximum dose of 10 mg/day, can be     safely administered with cisplatin, and concurrent radiotherapy, for patients with locally     advanced, inoperable, squamous cell carcinoma of the head and neck.   "
244614|NCT01057290|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how well patients will respond to treatment.      PURPOSE: This research study is looking at biomarkers in cell samples from young patients     with acute myeloid leukemia.   "
244615|NCT01057303|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is looking at gene expression in tissue samples from young     patients with acute myeloid leukemia.   "
244616|NCT01057316|"     The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on     the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.   "
244617|NCT01057329|"     The investigators aim to analyse in adolescents with mental illness effectiveness, side     effects, and serum level concentrations of antipsychotics (olanzapine and aripiprazole),     antidepressants (Duloxetine, Atomoxetine) by means of Therapeutic Drug Monitoring (TDM) in     order to optimize dosage - effect relations and minimize unwanted side effects.   "
244618|NCT01057342|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Dimethylxanthenone acetic acid may stop the growth of small cell lung cancer by     blocking blood flow to the tumor. Giving paclitaxel and carboplatin together with     dimethylxanthenone acetic acid may kill more tumor cells.      PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and     carboplatin together with dimethylxanthenone acetic acid and to see how well they work in     treating patients with extensive-stage small cell lung cancer.   "
244619|NCT01057355|"     Pancreatic cysts are common, and some pancreas cysts have malignant potential. Usual     treatment of these cysts is either observation or surgical removal of part or all of the     pancreas. Minimally invasive treatment via endoscopy has been described, using endoscopic     ultrasound (EUS) guided ethanol injections. Such studies exclude cysts that communicate with     the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol. In this     study, pancreas cysts communicating with the main pancreas duct are treated with ethanol via     endoscopic retrograde cholangiopancreatography (ERCP) and/or EUS.   "
244620|NCT01057368|"     This study is focused on the brain mechanisms and peripheral biological correlates of two     different forms of meditation--mindfulness-based and compassion/loving-kindness. Project 1 is     focused on the impact of compassion/loving-kindness meditation on emotional reactivity and     emotion regulation. Project 2 is focused on the neural and behavioral correlates of     mindfulness meditation and attention and pain regulation. In addition, Project 2 will examine     the relations between changes in oscillatory rhythms during meditation and attention and pain     processing. Project 3 will examine the impact of meditation on spontaneous brain activity     during sleep. This project will also examine the impact of intensive meditation on regional     changes in slow wave activity during subsequent sleep. Each of these projects will be     conducted on the same participants so that interrelations among the various measures     collected in the different projects can be examined. We believe that this study will     dramatically advance the understanding of the mechanisms by which meditation produces changes     in behavioral and biological processes.   "
244621|NCT01057381|"     The hypothesis of this study is that the administration of an intra-operative dose of     dexmedetomidine will result in adequate analgesia without respiratory depression thereby     resulting in an early discharge from the post anesthetic care unit following     adenotonsillectomy.   "
244622|NCT01057394|"     To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.        1. visually guided ablation (VGA) using the EAS-AC and        2. radiofrequency ablation   "
244623|NCT01057407|"     This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to     sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on     hemodialysis.   "
244624|NCT01057420|"     Prospective, controlled, randomized crossover volunteer study to investigate the effect of     hyperoxemia due to inhalation of oxygen (80% inspiratory fraction) via reservoir-face-mask on     blood coagulation, especially platelet function, as measured by thrombelastography. According     to results of basic animal and in vitro investigations, hyperoxemia may activate platelets by     means of reactive oxygen species. This study aims at investigating a possible pro-coagulant     effect of hyperoxemia in healthy volunteers. Additional studies on possible mechanisms are     integrated.        -  Trial with medical device   "
244625|NCT01057433|"     This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction     study.   "
244626|NCT01057446|"     The aim of the investigators study is to assess the bowel cleansing effects of two different     agents and to compare their safety of application, ease of usage and effects on serum     electrolytes.   "
244627|NCT01057459|"     This research trial studies deoxyribonucleic acid (DNA) analysis in predicting response to     antibody therapy in patients with follicular lymphoma treated on clinical trials Cancer and     Leukemia Group B (CALGB)-50402 or CALGB-50701. Studying samples of blood from patients with     follicular lymphoma in the laboratory may help doctors predict how well patients will respond     to treatment.   "
244628|NCT01057472|"     This is a study examining repeatability and feasibility of a new method for measurement of     lung function in babies. A flexible vest is placed around the torso of the baby, and changes     in tidal volume and flow is measured. The study will enable a better understanding of the     usefulness of this equipment in a neonatal intensive care unit. The equipment is made by     VOLUSENSE Norway AS, and marketed under the name FloRight. The equipment is owned by     Volusense Norway AS during the study period.   "
244629|NCT01057485|"     The purpose of the study is to assess combining AF ablation, with AV node ablation and     pacemaker implantation for patients suffering with 'irregular heartbeats' or atrial     fibrillation. The study will last 13 months.   "
244630|NCT01057498|"     The purpose of this study is two-fold. First, to determine whether nebulized RNS60 is safe in     healthy human subjects and in subjects with mild asthma, in a single-dose administration.     Second, to determine whether nebulized RNS60 is safe in human subjects with mild-to-moderate     asthma over a 4-week period.   "
244631|NCT01057511|"     Crinone is a micronized progesterone gel which is administrated via vaginal route and     targeted drug delivery to uterine (first uterine pass effect) with lower serum concentration.     This study is to investigate the difference of progesterone concentration in serum and     endometrium after administration with crinone and intramuscular progesterone.      The study will be conducted as a single centre, randomized, active controlled study.     Recruitment duration will be 6-8 months long. Day 1 of Crinone administration will be the     baseline. On Day 7 of Crinone administration endometrial tissue will be taken for P4 test.     Last visit will be at 3-5 days after withdraw bleeding.   "
244632|NCT01057524|"     High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucus     clearance compared with a control group. These observations led to the development of The     Vest® which is a non-stretchable jacket connected to an air-pulse generator and worn by the     patient over the chest wall. The generator rapidly inflates and deflates The Vest®, which     gently compresses and releases the chest wall between 5 and 20 times per second. This     generates mini-coughs that are said to dislodge mucus from the bronchial walls and to     facilitate its movement up the airways. The Vest® has been shown to reduce the viscosity of     mucus and this should further enhance mucus clearance.      People with cystic fibrosis (CF), admitted to hospital with an acute infective pulmonary     exacerbation, should increase the frequency and duration of their airway clearance sessions     owing to the increase in quantity and viscosity of purulent bronchial secretions.In the     United Kingdom, and in many other countries, the availability of physiotherapists to assist     with the recommended number of daily treatments is insufficient to meet patient need. If the     use of high frequency chest wall oscillation, in addition to 'usual' self airway clearance     techniques, in the early morning and evening was to facilitate recovery from an exacerbation,     this would indicate an important place for high frequency chest wall oscillation in the     management of people with cystic fibrosis.      Hypothesis:      The addition of high frequency chest wall oscillation to twice daily supervised physiotherapy     is as effective as the addition of self treatment in facilitating recovery from an acute     infective pulmonary exacerbation, as measured by improvement in lung function, specifically     forced expiratory volume in one second (FEV1).   "
244691|NCT01058291|"     This is a placebo-controlled double-blind crossover comparative study of KW-6500 in     Parkinson's disease patients with motor response complications on levodopa therapy. The     efficacy of KW-6500 is evaluated using the change of UPDRS part III score at double blind     period after 12 weeks subcutaneous self-injections.   "
244633|NCT01057537|"     People with established cardiovascular disease need secondary prevention that addresses     multiple risk factors. Complexity & cost confer particularly difficult barriers to uptake of     treatment; recovery from a stroke or heart attack typically necessitates multiple drugs for     cholesterol, blood pressure and platelet function. A low-cost, fixed-dose, once-daily     combination polypill, the Red Heart Pill, has been formulated by Dr Reddy's Laboratories.     UMPIRE will evaluate whether provision of this polypill compared with usual medications     improves adherence and clinical outcomes among high-risk patients in Europe and India. The     results will be used to develop recommendations for equitable access.   "
244634|NCT01057550|"     The purpose of this trial was to discover which type of operation for stress urinary     incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.   "
244635|NCT01057563|"     Restenosis due to neointimal hyperplasia causes repeat target vessel revascularization in a     relevant number of patients undergoing percutaneous coronary interventions (PCI).     Drug-eluting stents (DES) are currently adopted to reduce the rate of restenosis; however,     they may increase risk of stent thrombosis.      Experimental data and first clinical experiences showed that inhibition of neointimal     hyperplasia may be obtained by local administration of anti-proliferative drugs (like     paclitaxel) loaded on the surface of angioplasty balloons. Data on the efficacy of novel     coronary drug-eluting balloons (DEBs) are lacking.      Aims of this open label prospective, randomized trial is to evaluate neointimal hyperplasia     in patients undergoing bare-metal stent (BMS) implantation alone compared to those receiving     additional DEB use and to assess if the technique of DEB use may affect the degree of     neointimal hyperplasia.      Neointimal hyperplasia will be assessed by Optical coherence tomography (OCT).   "
244636|NCT01057576|"     Specific compounds in plants have been proposed to enhance human metabolism. The hypothesis     of the study was to evaluated the effect of an extract of Russian tarragon and to determine     is compounds in the plant can be measured in the serum of human subjects and whether the     compound may improve human metabolism as suggested in animal studies.   "
244637|NCT01057589|"     The purpose of this trial is to estimate progression free survival in patients with recurrent     or metastatic head and neck cancer that have not received chemotherapy in this setting.   "
244650|NCT01057758|"     The objective is to assess the efficacy and safety of oral simvastatin in patients with a     suspicion of ventilator-associated pneumonia (VAP). The hypothesis of this study is that     simvastatin therapy will improve mortality in patients a suspicion of VAP.   "
244651|NCT01057771|"     The overarching goal of this project is to determine whether mind-body practices such as     meditation or exercise can reduce the public health burden of acute respiratory infection. A     major secondary goal is to determine whether mindfulness meditation or moderately strenuous     exercise can enhance immune processes such as antibody response to influenza vaccination (flu     shots). Finally, we want to investigate the influence of stress, optimism, anxiety and     positive and negative emotion on immunity and resistance to respiratory infection.   "
244748|NCT01053000|"     To determine and compare the safety and efficacy of broad area photodynamic therapy with     aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with     occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with     an incubation time of 60 minutes, using blue light.   "
244638|NCT01057602|"     The purpose of this study is to apply a recently developed screening test for dementia, the     Memory Orientation Screening Test (MOST) to two additional groups. Group one is composed of     150 elders who do not have dementia and are residing in the community so that we can     determine what is a normal MOST score. These subjects will also be individually     administered a one-hour battery composed of other commonly used tests of memory and     information processing. Group two is composed of 150 elders who are administered the MOST by     a nurse as part of their regular visit to the primary care doctor's office, and their scores     will be compared against a rating of their cognitive ability made independently by the doctor     or another nurse. Their scores will also be compared with a list of their medical problems     and medications. Our hypothesis for the first group is that the MOST scores will be higher in     the normal group than in the previous clinical groups and that MOST scores will correlate     significantly with other neurocognitive tests. Our hypothesis for the second group is that     the MOST can be administered quickly and easily by briefly trained nurses, that it will     compare highly with doctor opinions, and that patients with known medical conditions related     to dementia, such as hypertension or diabetes, will have lower MOST scores than patients in     better health.   "
244639|NCT01057615|"     Combining fish oil and vitamin C supplementation will provide a greater anti-inflammatory     effect against developing exercise-induced bronchoconstriction (EIB) than either nutritional     supplement alone.   "
244640|NCT01057628|"     This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients     with type 2 diabetes mellitus.   "
244641|NCT01057641|"     Neurogenic intermittent claudication is a specific symptom complex occurring in patients with     lumbar spinal stenosis. Characteristic of this disease is the occurrence of increasing leg,     buttock or groin pain with or without lower back pain when walking a certain distance or     reclining. Bending forward or sitting leads to a rapid pain relief. Lumbar spinal stenosis is     defined as a reduction of the diameter of the spinal canal. The mechanism leading to stenosis     is a remodeling and overgrowth of the spinal canal with osteophyte formation. Any loss of     tissue or decrease of the disc height results in a relative laxity of the ligament structures     and accelerates the degeneration of the spinal joints. As a therapy option, conservative     therapy with oral analgesics and physical therapy is considered. This treatment can be     intensified by adding epidural pain treatment. Is the conservative treatment not successful     surgical intervention is necessary. In patients over 65 years of age operative decompression     of the lumbar spinal stenosis constitutes the most common surgical operation of the spine. A     relatively new therapy alternative is the interspinous process decompression (IPD). Studies     have shown that the IPDs prevent narrowing of the spinal canal and neural foramens. The study     is intended as a randomised, monocentre study to investigate the safety and the benefit of a     minimally invasive percutaneous IPD-device in comparison with the best non-surgical operative     treatment of lumbar spinal stenosis.   "
244642|NCT01057654|"     Lifibrol is a new lipid-lowering drug which lowers cholesterol to an extent in the order of     magnitude of the statins. The mechanism of action of this compound is different from the one     of statins but remains unknown. The current study will investigate the mechanism of action     using stable-isotope turnover methods. The study will be done in healthy male volunteers.   "
244643|NCT01057667|"     This equally randomized (1:1), double-blind, parallel arm study will assess the safety and     antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus     Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in     arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys     (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a     rapid virological response (RVR) at week 4, sustained through week 22, will stop all     treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for     another 24 weeks up to week 48. Patients in arm B will receive standard treatment with     Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks.     Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.   "
244644|NCT01057680|"     As we age, we experience a reduction in muscle and bone which inevitably decreases strength     and the ability to perform tasks of daily living such as gardening, carrying groceries, and     climbing stairs. Health costs associated with aging muscle and bone loss are in the billions     of dollars. With the projected increase in life expectancy, the incidence of muscle and bone     loss will rise and further drain the healthcare system, with greater need for     hospitalization, treatment, and rehabilitation. Without effective strategies to counteract     aging muscle and bone loss, we may face a healthcare crisis in the future. Creatine, a     compound found in red meat and seafood, increases creatine phosphate stores in muscle,     providing increased energy during high-intensity exercise. Short-term (i.e. 3-4 months)     resistance-exercise and supplementation with creatine, have been shown to have a favorable     effect on properties of aging muscle and bone. However, the longer-term (i.e. 1 year) effects     of these interventions are unknown. Therefore, the purpose of this innovative research is to     determine the longer-term effects of resistance-exercise and creatine supplementation     (0.1g•kg-1) in older adults. The primary dependent variables to be assessed will include     muscle hypertrophy, bone mineral and bone geometry, strength, and urinary and blood     indicators of liver and kidney function. This innovative, multidisciplinary research will     help contribute to the successful pursuit of prolonged independent living by improving aging     musculoskeletal health for older Saskatchewan adults. Saskatchewan provides a relevant     setting for this research, given the higher percentage of older adults (15%), compared to the     national average (12%).      We hypothesize that creatine supplementation will increase muscle mass, strength, and bone     mineral density more than placebo.   "
244645|NCT01057693|"     Patients will be switched from their current medication for painful diabetic peripheral     neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All     patients will receive pregabalin, and half of patients will receive placebo at some point     during the study.   "
244646|NCT01057706|"     This study will compare the effectiveness of chiropractic and exercise treatment in the     short- and long-term, when managing chronic neck and back disability in seniors over the age     of 65 years.   "
244647|NCT01057719|"     The aim of the study was to compare the effect of inpatient physiotherapy in a warm climate     versus physiotherapy in a colder climate in multiple sclerosis (MS), in both short- and long     term perspectives.   "
244648|NCT01057732|"     Primary hyperparathyroidism (PHPT) is associated with increased cardiovascular morbidity. The     benefit of surgical treatment in this respect is unclear.      This study was performed to evaluate the impact of parathyroidectomy (PTX) on cardiovascular     risk profile.   "
244649|NCT01057745|"     Women of reproductive age who will undergo cancer treatment may participate in a study to     surgically remove ovarian tissue and store it, frozen, for their potential use in the future.     20% of collected tissue will be used for research.   "
244652|NCT01057784|"     The UCLA Metabolic and Bariatric Surgery Program (adult program) and the UCLA Fit for Healthy     Weight Program (adolescent program) are committed to the care of morbidly obese patients.     This study is observational. The investigators plan to evaluate bariatric surgery outcomes     using the BAROS National Database and also to evaluate quality of life pre- and post     bariatric surgery. In addition, the investigators plan to enroll a subgroup of 10     reproductive-age women to evaluate: 1) pregnancy and offspring health, 2) long-term     nutrition, 3) biomarkers/epigenome, and 4) body-composition/bone-density.   "
244653|NCT01057797|"     This is a four month exercise training program for people with chronic obstructive pulmonary     disease (COPD)with a 12 month follow-up.   "
244654|NCT01057810|"     The purpose of this study is to determine if asymptomatic or minimally symptomatic patients     with metastatic prostate cancer who have not received chemotherapy live longer when treated     with ipilimumab than those treated with a placebo   "
244655|NCT01057823|"     The overall goal of this research is to elucidate how environmental, healthcare, and     patient-level factors and patients' level of perceived control impact sleep duration and     quality in hospitalized older patients and to assess whether better in-hospital sleep is     associated with improved physical activity and health outcomes.      We hypothesize that environment, healthcare disruptions and patient symptoms will be     significantly associated with objective and subjective sleep duration and sleep quality in     hospitalized older patients.      We also hypothesize that a high level of perceived control will be associated with improved     sleep duration and quality in hospitalized older patients.      We further hypothesize that shorter sleep duration and quality in hospitalized older adults     will be associated with adverse health outcomes, namely higher blood pressure and blood     sugar.   "
244656|NCT01057836|"     The purpose of this study is to determine whether intensive one-year neck strength training     can enhance health related quality of life in females with chronic neck pain.   "
244657|NCT01057849|"     Schizophrenia is not a curable but a treatable disease by antipsychotics. Kinds of atypical     antipsychotics are widely used since 1990s' in China. Although their efficacy for acute phase     are all better than typicals, individulized regimen of them for first-episode schizophrenia     and their effectiveness in real naturalistic clinical settings still remain unclear. And     those patients also need more comprehensive intervention such as psychosocial programs to     improve their function. This protocol is to conduct a study in several sites of China to     investigate the effectiveness of comprehensive intervention combining sequenced atypical     antipsychotic therapy and intensive psychosocial intervention for first-episode schizophrenic     patients. In addition, this protocol also aims at collecting such information as molecular     genetics, neurochemical test, neucognitive performance and neuroimaging for outcome analysis.   "
244658|NCT01057862|"     The investigators plan to investigate the safety, tolerability, and efficacy of the opioid     antagonist naltrexone in Pathological Gambling. We hypothesize that naltrexone will be     superior to placebo in reducing gambling urges and behavior, when combined with adjuvant     non-pharmacological treatment as usual.   "
244659|NCT01057875|"     To investigate whether or not the ingestion of caffeine with alter airway responsiveness to     methacholine and/or change the level of exhaled nitric oxide.   "
244660|NCT01057888|"     The investigators will design and implement a randomized clinical trial to test, on a     community-wide level, the effectiveness of managed care based tracking/reminder/recall on     improving vaccination coverage among adolescents.      The investigators propose a randomized controlled trial to evaluate the effectiveness of     reminder/recall for adolescents: 10,599 adolescents within the managed care organization     (MCO) will be randomized into one of three arms: 1) mailed reminders, 2) autodialer telephone     messages or 3) standard of care of their practice (no messages from the intervention).      Hypothesis 1: Reminder/recall will increase the receipt of immunizations and preventive     services      Hypothesis 2: Telephone (autodialer) reminders will be more effective than mailed reminders      Hypothesis 3: The impact of reminders will be greatest for the most high-risk subgroups which     have low baseline immunization rates.      Hypothesis 4: Mailed reminders will be more costly (and less effective) than telephone     reminders.   "
244661|NCT01057901|"     The objective of this trial is to assess the safety and efficacy of 24-week course of     flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally     postmenopausal women.   "
244662|NCT01057914|"     The purpose of this study is to evaluate the effects of nutritional therapy in elderly     malnourished patients. The hypothesises are that nutritional supplementation and dietary     advice alone or in combination affects mortality, quality of life and health-care consumption     after six month of treatment.   "
244663|NCT01057927|"     The purpose of the study is to investigate the clinical effects of multiple (28 day)     twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild     to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting     inhaled B2-adrenergic agonists for symptomatic control.   "
244664|NCT01057940|"     Is DBE(double balloon enteroscopy)-assisted DPEJ(direct percutaneous endoscopic jejunostomy)     a viable option in patients who have failed conventional DPEJ placement and who otherwise     would require surgical jejunostomy or parenteral nutrition.   "
244695|NCT01058343|"     Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus     (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be     an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a     polyclonal antibody response.      This study will evaluate the safety of IFN-K in patients with mild to moderate SLE. It will     also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE     disease.   "
244749|NCT01053013|"     This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for     patients with pancreatic cancer (all stages) and advanced colorectal cancer that no longer     responds to standard therapies.      The treatment is being evaluated for its effect on tumor growth. It consists of the placement     (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA     macrobeads). The cells in the macrobeads produce substances that have been shown to slow or     stop the growth of tumors in experimental animals and veterinary patients. It has been tested     in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II     studies in patients with colorectal, pancreatic or prostate cancers are in progress.   "
244665|NCT01057953|"     The majority of the clinical situations suggestive of an increased genetic risk for     colorectal cancer (CRC) are not explained by a simple monogenic model. Our working hypothesis     is that a fraction of clinical conditions suggestive of an increased genetic risk for CRC     (familial aggregation, early age of tumour onset, development of multiple primary CRC) is due     to the combination of a limited number of genetic variations, each conferring a moderate risk     for CRC, but whose combination results into high risk.      This study, which will be both retrospective and prospective, is an association study that     will compare frequencies of selected genetic variations, alone or in combination, between     patients (cases) whose clinical presentation is suggestive of an increased genetic risk but     who do not present a known Mendelian form of CRC, and controls, in order to assess     associations of these variations with non-Mendelian genetic forms of CRC. The inclusion     criteria will be: CRC in two first degree relatives, one being diagnosed before 61 years of     age; or CRC diagnosed before 51 years of age or advanced colorectal adenoma before 41 years     of age; or multiple primary CRCs in the same individual, the first being diagnosed before 61     years of age The exclusion criteria will be: Lynch syndrome, adenomatous polyposis and     hamartomatous polyposis. The genetic variations which will be analyzed will include (i) SNPs     detected by GWAS and associated to CRC. (ii) Risk factors corresponding to functional     polymorphisms within candidate genes. (iii) Imbalance of the TGFbR1 allelic expression.     Sample sizes were calculated to obtain 80% power for an odds ratio of 2.5 since the aim of     this study is to determine genetic variations conferring a moderate risk. In order to cover     all these possibilities and to have reasonable even for the genetic variations with low     frequency below 0.03 or high frequency above 0.90, the target sample size was set at 700     cases and 350 controls. The recruitment of patients will be performed at the national level     by the cancer genetics departments ensuring a correct evaluation of the personal and familial     history and the French molecular diagnosis laboratories network ensuring in routine the     analysis of the main genes involved in CRC. The control population will be composed of     healthy subjects of Caucasian origin between 45 and 60 years of age, without personal or     familial history among their first-degree relatives of colorectal tumours.      Demonstration that the combination of a limited number of genetic variations, each conferring     a moderate risk for CRC, results into high risk would allow to base, in selected families,     the evaluation of risk in relatives and indication of colonoscopy on the analysis of gene     variants the combination of which would confer a high risk. This study will confirm or     invalidate the contribution of aTGFbR1 allelic expression imbalance in the determinism of     early-onset CRC and familial aggregation of CRC. The demonstration of the involvement in CRC     genetic variations with strong effect of specific combinations should be of interest for our     general understanding of the molecular basis of CRC.   "
244666|NCT01057966|"     This study is a comparison of the bioavailability of nutrients contained in softgel capsules     vs tablets.   "
244667|NCT01057979|"     Engagement in substance-free activities, such as exercise, has an inverse relationship to     substance use in college students. While exercise has numerous physical and mental health     benefits, the majority of college students are sedentary, infrequently engaging in exercise.     Although exercise interventions to date often suffer from significant attrition and poor     adherence, motivational interventions for exercise are beginning to show promise. In this     pilot study we propose to develop and evaluate a novel exercise intervention combining     Motivational Enhancement Therapy (MET) with contingency management (CM) in sedentary college     students who use alcohol.   "
244668|NCT01057992|"     A medical device to augment weak lower esophageal sphincter function.   "
244669|NCT01058005|"     This was a multicenter, randomized, open-label, parallel-group, active-controlled study.     Prior to randomization, participants were to have been treated with glatiramer acetate or     interferon β-1a (44 μg). Participants were to be randomized to receive natalizumab,     interferon β-1a 44 μg, or glatiramer acetate.   "
244670|NCT01058018|"     The purpose of this study is to investigate dose range, safety and efficacy of RVX000222 in     subjects with stable coronary artery disease.   "
244671|NCT01058031|"     The purpose of this study is to compare Mindfulness Based Stress Reduction to a supportive     therapy control group.   "
244672|NCT01058044|"     The purpose of this study is to describe adherence to 3 oral anticancer treatment: i) a     chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or     sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor.     Moreover, this study is aimed at evaluating the feasibility to use a  Medication Event     Monitoring System  (MEMS®) in order to assess adherence of an oral anticancer treatment     delivered by dispensary pharmacy.   "
244673|NCT01058057|"     This study investigates potential protective effect of atorvastatin pre-treatment in patient     with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) on     chronic statin therapy. Patients are randomized into two groups: atorvastatin pre-treatment     group (80mg atorvastatin seven days before PCI) and control group (PCI without atorvastatin     pretreatment, chronic statin treatment). Endpoint is myocardial infarction measured by     troponin I and creatine kinase myocardial band.   "
244674|NCT01058070|"     Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function     in the treatment of Gastroesophageal Reflux Disease (GERD)   "
244675|NCT01058083|"     The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects     on LDL cholesterol (LDL-C)   "
244703|NCT01058447|"     The purpose of the study is to characterize the absorption, distribution, metabolism and     excretion (ADME) of a single oral dose of [14C]AZD1981   "
244677|NCT01058109|"     The aim of this experimental study was to test the effect of increasing dietary calcium     intake to 1500 mg/day on increases in bone quality in adolescent females. The hypothesis to     be tested is: adolescent females who consume a high calcium diet will have a greater increase     in bone quality, as measured by densitometry and ultrasound, than adolescent females who     consume their usual dietary calcium intake.   "
244678|NCT01058122|"     The proposed cohort study collected within a 5-month observation period adverse drug reaction     (Adverse Drug Events - ADE) in patients at the Department of Oncology at the University of     Zurich. ADE have been recorded using prospective monitoring and assessed using standardized     algorithms regarding causality and severity. Data sources included information from the     medical records, laboratory values and internal rounds. Additional information has been     collected using a standardized patient questionnaire.      The primary endpoints of this study are to determine the frequency of ADE, the comparison of     the quality of data sources and collection methods for the detection of ADE in regard to     patient characteristics, size, number of medications, the category of ADE, severity,     causation, diagnosis, hospitalization, cause of hospitalization and medication cause.     Secondary endpoint is the assessment of the ADE causality, severity and predictability.   "
244679|NCT01058135|"     The purpose of this study is to determine the effects of a dietary fiber, resistant starch,     on insulin sensitivity. Low insulin sensitivity is a risk factor for some diseases including     type 2 diabetes and heart disease. This study will show if consuming resistant starch can     help improve insulin sensitivity in overweight and obese people.   "
244750|NCT01053026|"     The aims of this clinical trial are to assess the impacts on vascular function tests and     circulating biomarkers of a short-term (12-week) low-to-median intensity exercise training or     ARBs treatment in patients with DM and hypertension.   "
244680|NCT01058148|"     Background:        -  The Mississippi Delta (which includes the counties along the Mississippi River) is one          of the poorest areas in the United States. Women living in the Mississippi Delta have          disproportionately high rates of cervical cancer, but they are unlikely to come to          clinics except perhaps for giving birth, years before they are diagnosed with cancer.        -  To improve rates of screening, researchers are attempting an outreach study to see          whether under-screened women, if approached by door-to-door recruitment, would get          screened by one of two methods (home-based self-collection and testing, or a clinic          exam) and which method they would prefer.      Objectives:      - To assess/measure increased participation of under-screened women living in the Mississippi     Delta in cervical cancer screening by offering women the opportunity to get screened by one     of two possible community outreach-based cervical cancer screening modalities,     self-collection and HPV testing or clinic-based cytology screening, the current standard of     care.      Eligibility:      - Women between 26 and 65 years of age, who are not pregnant currently or in the past 8     weeks, have an intact cervix, have no history of cancer, and have not been screened for     cervical cancer in the past 3 years.      Design:        -  Researchers will recruit participants on a door-to-door basis. Researchers will recruit          all eligible women within a household. Recruitment will be done only during daylight          hours but at the end of the working day to maximize the chances of finding women at          home.        -  Eligible women willing to participate will complete a questionnaire with demographic and          medical information.        -  Participants will be asked to choose the screening method of their preference. If they          choose self-collection with HPV testing, they will be given a self-collection kit and          asked to perform the self-collection and return the kit within 1 month. Participants who          choose to have cytology screening will be provided with the phone number and location of          the local health department clinic and will be encouraged to schedule their screening          within the following month.        -  Women who do not complete their participation within 1 month will be considered          noncompliant with their chosen intervention. Researchers will re-contact noncompliant          women to offer them participation in the study, including permitting them to refuse to          participate or to choose the alternative intervention....   "
244681|NCT01058161|"     The present project aims at evaluating the diagnostic potential of high-field MRI (3 Teslas)     for joint disease. At this field, given that isotropic image resolution of 400 microns can be     obtained, one could expect an early detection of joint abnormalities. The additional aim of     this project will be to develop a quantitative analyse of the corresponding high-resolution     images.   "
244682|NCT01058174|"     Prevention of invasive fungal infection in high risk patients following liver transplant.   "
244683|NCT01058187|"     To compare amounts of DHA, ARA, and other fatty acids in the blood cells of infants consuming     infant formulas containing differing levels of fatty acids   "
244684|NCT01058200|"     The hypothesis is that the new vacuum assisted delivery device iCup is more effective than     the reference cup, in terms of maternal and newborn morbidities and functioning   "
244685|NCT01058213|"     This is a 16 week exercise training program for people with severe to very severe chronic     obstructive pulmonary disease (COPD). The purpose of this study is to find out if performing     strength training prior to initiating exercise training on a stationary bicycle is associated     with greater gains in functional status than bicycle training alone or concurrent bicycle and     strength training together.   "
244686|NCT01058226|"     This is a prospective, single arm, single intervention safety and immunogenicity study in 6     healthy, malaria-naive adults, conducted to demonstrate the successful implementation of the     well-established malaria challenge model at the Seattle Biomedical Research Institute     (Seattle BioMed).   "
244687|NCT01058239|"     Post transplant lymphoproliferative disease (PTLD) is a type of B-cell non-Hodgkin lymphoma     that occurs in patients with weakened immune systems due to immunosuppressive medications     taken after organ or stem cell transplantation. This is usually related to a virus called     Epstein-Barr (EPV). Rituximab is a type of drug called an antibody that specifically     destroys both normal and cancerous B-cells, and is commonly used for PTLD. Bortezomib is a     drug that has been approved by the Food and Drug Administration (FDA) to treat multiple     myeloma and a B-cell non-Hodgkin lymphoma called Mantle Cell Lymphoma, and shows significant     activity in lymphoma cells caused by EBV. In this research study, we hope to learn if the     addition of bortezomib to rituximab treatment can increase the rate of complete remissions     and cures of PTLD after organ or stem cell transplant.   "
244688|NCT01058252|"     The purpose of this study to evaluate a low cost minimal stimulation protocol combined with     Intravaginal Culturing, to make IVF affordable and available across the large     infertile/subfertile population   "
244689|NCT01058265|"     Patients with a diagnosis of chronic fatigue or pain benefit minimally from a conventional     medical evaluation yet consume a large amount of medical resources and time. The question is     to see if patients with a diagnosis of chronic pain or fatigue benefit from an Integrative     Medicine medical evaluation conducted by physician who has additional training in Integrative     Medicine. Patients who call for a general medical examination with a complaint of chronic     fatigue or pain will be set up with the integrative medical specialist or standard general     medical evaluation.   "
244690|NCT01058278|"     The present study's main objective is to assess if there is a significant difference between     either of the treatments frequently used in post-op, namely a topic cortisone-based     treatment, an non-steroidal anti-inflammatory drug (NSAID) or simply a placebo, in order to     gain the best long term (6 months) efficacy of the SLT.   "
244715|NCT01047267|"     The objective of this study is to determine whether pharmacokinetic parameters of     anidulafungin correlate with disease severity and plasma protein levels in critically ill     patients.   "
244692|NCT01058304|"     Pain management is a priority for the Department of Veterans Affairs (VA) health care system,     and knee osteoarthritis (OA) is a main cause of chronic pain. Veterans who receive care     within the VA health care system have higher rates and more severe OA than both the general     population of adults and veterans who receive health care elsewhere. Physical therapy (PT) is     a primary part of treatment for knee OA, but in the VA health care system PT appointments are     a limited resource, and veterans often do not receive enough visits to promote long-term     improvements in pain and physical function. New models of delivery, such as the group-based     approach examined in this study, are needed to expand PT services in a cost-effective manner.   "
244693|NCT01058317|"     Juvenile onset recurrent respiratory papillomatosis (JORRP) is a rare, difficult to treat,     benign tumor of the pediatric airway. Current therapy is mainly surgical, but in a     significant portion of patients adjuvant therapy is required to control the disease process.     Although multiple adjuvant medical therapies have been tried, success has been limited. We     have seen some success in a limited amount of patients using orally administered propranolol.     Our goal is to enroll a larger cohort of patients to determine the effectiveness of     propranolol as an adjuvant therapy for JORRP.   "
244694|NCT01058330|"     A physical training program will improve quality of life, participation in physical activity,     motor coordination, muscle strength, and bone and muscle strength in children with     neurofibromatosis type 1.   "
244696|NCT01058356|"     Antibiotic-Associated Diarrhea (AAD) is a common complication of antibiotic use. The     frequency of AAD can be high (26 - 60%) or moderate (13-29%) during hospital outbreaks and is     relatively infrequent in outpatients. The risk factors for AAD include broad-spectrum     antibiotics, host factors (age, health status, and gender), hospitalization period and     exposure to nosocomial pathogens. AAD occurs 2-8 weeks after exposure to antibiotics as a     result of disrupting normal intestinal microflora. One of the roles of normal intestinal     microflora is to act as a protective barrier that resists the colonization of intestinal     pathogens. These patients are susceptible to infection by opportunistic pathogens without     this protective barrier. Probiotic therapy is suited to AAD and Clostridium difficile     disease. Probiotics assist in reestablishing the disrupted intestinal microflora, enhancing     immune responses and clearing pathogens and their toxins from the host. Studies using     probiotics have been reported for the past twenty-eight years (1977~2005), but the studies     have been variable in trial designs and types of probiotics, had differing doses and     durations of treatment, and thus have yielded controversial results. The investigators will     conduct a multi-center, randomized, placebo-controlled, double-blind trial to assess the     efficacy of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults.   "
244697|NCT01058369|"     Study outline: Deferasirox (Exjade®) is regularly used in severe iron overload in order to     avoid organ damage of liver, heart and other organs. It has been proposed, that iron overload     may not only impose damage to other organs but also to the bone marrow and thus worsen     hematopoietic insufficiency in patients with MDS. Patients presenting with low or INT-1 risk     MDS with only mild iron overload will be treated with deferasirox in this study. It will be     analyzed if hematological improvement can be observed during this treatment.   "
244698|NCT01058382|"     There have been two very common forms of progesterone administration that have been used     during ovulation induction, in vitro fertilization (IVF) and embryo transfers. There are     currently no randomized clinical trials to demonstrate which method of progesterone     administration is more effective for frozen embryo transfer. We raise the question: Is there     a difference between the two accepted methods of progesterone administration, intramuscular     and vaginal suppositories, for frozen embryo transfer? Studies for fresh embryo transfer     after in vitro fertilization, have demonstrated that there is not a difference between the     two methods of progesterone administration. We will evaluate the question for frozen embryo     transfer.   "
244699|NCT01058395|"     The purpose of this study is:        1. To assess the safety and feasibility of minocycline administration after TBI in a dose          escalation study at two different doses over 7 days.        2. To assess the pharmacokinetic characteristics of two different dosing regimens of          minocycline in TBI patients, the effect on biochemical markers of neuroprotective          mechanisms, and effect on neurobehavioral and functional outcome.        3. To begin initial assessment of the efficacy of minocycline as a therapeutic agent for          severe human TBI.   "
244700|NCT01058408|"     RAD001 is approved by the U.S Food and Drug Administration (FDA) to treat advanced kidney     cancer. This drug has also been used in other research studies to evaluate its effectiveness     in other cancers. Information from these research studies suggests that RAD001 may help to     decrease the growth and development of tumor cells by reducing the blood supply that tumors     need to grow. In this research study, we are trying to determine the safety of RAD001 when     given to people with locally advanced head and neck cancer in combination with cisplatin and     radiation. We are also looking for the highest dose of RAD001 that can be given to people     safely.   "
244701|NCT01058421|"     Acute respiratory failure is a heterogeneous disorder that results in more than 300,000     Americans requiring admission to an intensive care unit for invasive mechanical ventilatory     support each year. Though acute respiratory failure is a pulmonary disorder, patients who     survive their hospitalization are not limited by respiratory symptoms after discharge. Rather     persistent neuromuscular weakness is the primary disorder that adversely alters their quality     of life and ability to function on a daily basis. In this application the investigators plan     to conduct a randomized clinical trial called the Do It Now study (Diagnosis and Treatment of     Neuromuscular Weakness) to determine the effectiveness of an intensive physical therapy     program for patients recovering from acute respiratory failure. This trial will establish the     efficacy of the physical therapy programs that is currently performed for patients with acute     respiratory failure in a non-evidence based manner across the United States.   "
244702|NCT01058434|"     This study will evaluate safety and efficacy of TKI258 in patients with relapsed or     refractory multiple myeloma   "
244704|NCT01058460|"     To compare the effects of conventional cytology testing with concommitant HPV-cytology     testing for the detection of high grade cervical lesions in primary cervical cancer screening     in Hong Kong      Hypotheses:        1. There is a significant difference in the number of CIN2+ cases detected between the          cytology testing group and the cytology-HPV co-testing group at baseline.        2. Significantly more CIN2+ cases will be detected at the second round of screening among          participants with normal cytology result in the control arm than those with normal          cytology and negative HPV results in the intervention arm.   "
244705|NCT01058473|"     Historically, sickle cell disease has not been viewed in the chronic pain paradigm because of     its recurrent nature. Patients with sickle cell disease may be hospitalized for extended     periods of time. As the hospital stay progresses, patients with SCD pain are often observed     by clinicians to have improvements in function in areas such as self-care, mobility, and     recreation despite continued self-report of high pain scores. This pattern of functional     improvement with continued report of high pain intensity scores is common in patients with     recurrent and chronic pain. A functional assessment tool that can assess function in the     acute inpatient setting is needed.      The purpose of this study is to evaluate the Inpatient Pediatric Physical Activity     Questionnaire (IPPAQ), as a measure of daily function in children with sickle cell disease     hospitalized with vasoocclusive pain.   "
244745|NCT01052961|"     Adult patients hospitalized with influenza have higher viral loads and more severe illnesses.     Thus more aggressive treatment approaches (e.g. higher dose oseltamivir) have been suggested     to treat patients suffering from severe influenza infection.      The investigators plan to investigate the impact of higher-dose oseltamivir (150 mg b.d.)     treatment on viral clearance and clinical recovery in adult patients hospitalized for severe     influenza. Such information may lead to optimization of the management strategy used for     these patients.   "
244706|NCT01058486|"     The investigators' proposed study is a randomized controlled trial that will prospectively     examine the effect of a multicomponent intervention on the rate of hospitalizations, daily     physical activity, self efficacy and health status in patients who have COPD and have been     hospitalized because of a COPD exacerbation.      In the study, a convenience sample of patients recently hospitalized for a COPD exacerbation,     who meet the selection criteria and agree to participate will be randomized to receive one of     the following at the time of hospital discharge: (1) the current standard of care plus a     multicomponent intervention (counselor + pulmonary rehabilitation) or (2) the current     standard of care without the intervention.      This study plans to test the following hypotheses: (1) The primary outcome of the study to be     the composite endpoint of death or COPD hospitalization (2) Time to first rehospitalization     will be shorter in the intervention group than the control group (3) At follow-up, the     physical activity level measured in terms of the average number of steps and active energy     expenditure will be higher in the intervention group than in the control group.   "
244707|NCT01058499|"     The objective of this study is to test the efficacy of a Mindfulness Based Stress Reduction     program in COPD on quality of life, dyspnea, daily physical activity and mindfulness during     daily life.   "
244708|NCT01058512|"     The purpose of this research study is to find out the effect of the investigational drug     NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated     at different doses when taken by subjects with hepatitis C.   "
244709|NCT01058525|"     The real-time visualization of a needle and nerve during an ultrasound-guided nerve block can     be challenging. These difficulties may partly explain the systemic complications of local     anesthetics under ultrasound. Injection of small amounts of a solution around the     anesthetized nerve (hydro-dissection) has been proposed to enhance contrast outlining its     borders and also to improve the visualization of the needle tip. The glucose solution 5%     solution is interesting because it allows, unlike saline, to maintain the motor response with     neurostimulation. The hydro-dissection can be particularly useful when one suspect hypoechoic     vessels near the nerve to be anesthetized. Thereby, the nerve well demarcated and separated     from the vessels, injection of local anesthetic is performed in the circumferential diffusion     space (like a small pocket) without redirecting needle.      The influence of this hydro-dissection on the nerve block efficiency is unknown. The nerve     block quality can be improved because the entire anesthetic is injected in contact with the     nerve, but it can also be reduced due to the dilution of the local anesthetic by the glucose     solution.      In this randomized study, the investigators test the hypothesis that hydro-dissection does     not alter the nerve block onset time.   "
244710|NCT01058538|"     This is a Phase I/II study for patients with solid tumors and renal cell carcinoma (RCC; for     the Phase II part). L19-IL2 is a tumor targeted immunocytokine constituted of a single chain     Fragment variable (scFv) format directed against the ED-B domain of fibronectin, one of the     most important markers for neoangiogenesis, and the human cytokine interleukin-2 (IL2).   "
244711|NCT01047202|"     A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months     infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine     (PANFLU.1).   "
244712|NCT01047215|"     The goal of this research is investigating the heart rate changes in schizophrenic and     bipolar patients under the medication of aripiprazole and quetiapine. In the mean time, we     are hoping further investigating the interrelationship of medicine dosage and heart rate     change, in order to acquire the best relationship both effectiveness as well as safety in     acceptable heart rate change of clinical suggestion.   "
244713|NCT01047241|"     The aim of the study is to investigate the absorption and clinical effect of nasal     administration of an analgesic nasal spray containing sufentanil+ketamine for pain related to     medical procedures in hospitalized children.   "
244714|NCT01047254|"     Apathy in dementia prevents successful application of non-pharmacological treatments,     accelerates cognitive and functional decline and increases disease-related costs by earlier     need for full-time care. Apathy is a distinct entity and occurs independently of other     neuropsychiatric syndromes, like depression.      Today, there is no high-level evidence for any effective treatment of apathy in AD. In     contrast to other neuropsychiatric syndromes in AD, like psychosis and depression, and     despite its high prevalence and clinical relevance, apathy has never been the primary outcome     in a clinical trial. Basic and clinical research has provided a distinct model of the     pathophysiology of apathy with dopamine and norepinephrine as the key neurotransmitter     systems involved. The antidepressant Bupropion is a dopamine and norepinephrine reuptake     inhibitor. There is evidence from case-series, that Bupropion reduces apathy in patients with     organic brain disorders. This study will test the efficacy and safety of Bupropion in the     treatment of apathy in AD in a 12-week multicenter doubleblind placebo controlled trial.     Secondary endpoints will be quality of life of patients, caregivers' distress, ability of     patients to perform activities of daily living,utilization of healthcare resources by     patients and by caregivers, and cognitive functions.   "
244716|NCT01047280|"     The purpose of the study is to examine how a naturally occurring fat found in meats, such as     beef and lamb and milk, called conjugated linoleic acid (CLA), will affect your body weight     and body fat content, blood fat levels, as well as selected safety parameters. The CLA will     be supplemented in an oil form and will be added to solid foods as provided by the metabolic     kitchen at the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN).   "
244746|NCT01052974|"     Therapeutic essay of phase IV, monocentric, prospective, randomized, in double-blind during     48 hours(then simple-blind),controlled by placebo.      Abstract:      The increasing incidence of the number of femoral neck fractures and the poor prognosis of     this traumatological pathology involves an optimization of the diagnostic, therapeutic and     analgesic care.      A widespread collectively practice for the analgesia in prehospital or preoperative period is     the single injection (single shot) of local anesthetic with the technique of the femoral or     iliofascial block. Nevertheless the single injection of a dose of local anesthetic associated     or not with analgesic adjuvants, due to their pharmacological properties, can't prolong the     efficiency of the loco-regional analgesia more than 12 hours.      The aim of our study is to evaluate, in the patients admitted in emergencies for suspicion of     femoral neck fractures, the perioperative efficiency of an analgesic treatment using a     femoral perineural catheter (inserted from the hospital admission) with continuous infusion     of ropivacaïne controlled by placebo (physiological serum).   "
244717|NCT01047293|"     RAD001 (everolimus) is a novel oral derivative of rapamycin. RAD001 has been in clinical     development since 1996 as an immunosuppressant in solid organ transplantation and has     obtained marketing authorization (Certican®) for prophylaxis of rejection in renal and     cardiac transplantation in a number of countries, including the majority of the European     Union. RAD001 has been in development for patients with various malignancies since 2002.      RAD001 is being investigated as an anticancer agent based on its potential to act:        -  Directly on the tumor cells by inhibiting tumor cell growth and proliferation        -  Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent          inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced proliferation          of endothelial cells). The role of angiogenesis in the maintenance of solid tumor growth          is well established, and the mTOR pathway has been implicated in the regulation of tumor          production of proangiogenic factors as well as modulation of VEGFR signaling in          endothelial cells.      At weekly and daily schedules and at various doses explored, RAD001 is generally well     tolerated. The most frequent adverse events (rash, mucositis, fatigue and headache)     associated with RAD001 therapy are manageable. Non-infectious pneumonitis has been reported     with mTOR inhibitors but is commonly low-grade and reversible.      Both FOLFOX and bevacizumab are well established for treatment of metastatic colorectal     carcinomas. FOLFOX-6 can be combined safely with Bevacizumab and is currently in phase 3     testing for adjuvant therapy and is commonly used as a first line treatment regimen for     metastatic colorectal cancers 25. There is an enhanced interest in development of more     effective regimens for colorectal cancers. RAD001 is a mTOR inhibitor that has preclinical     and clinical activity in colorectal cancers. RAD001 downregulates the mTOR pathway which can     lead to direct antiproliferative effects as well as decreased production of Vascular     Endothelial Growth Factor. A combination of RAD001 at 10 mg per day in combination with     Bevacizumab 10 mg/kg every 2 weeks has been shown to be efficacious and safe. In another     trial, RAD001 was shown to have many patients with stable disease and clearly needs to be     given in combination therapy.   "
244718|NCT01047306|"     The purpose is to evaluate the course of disease progression in MPS IIIA patients who are     untreated to identify potential surrogate endpoints that may be utilized in future ERT trials     of MPS IIIA via defined assessments including standardized clinical, biochemical,     neurocognitive, behavioral, developmental, and imaging measures.   "
244719|NCT01047319|"     To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled     MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability     and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing     multiple sclerosis.   "
244720|NCT01047332|"     The purpose of the study is to determine the best management of bile duct narrowing     (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the     liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct     causing pain, jaundice (yellow skin and eyes), itchy skin and fever.   "
244721|NCT01047345|"     This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women     between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants     will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the     Base Study. Participants who receive placebo in the Base Study will be eligible to receive     vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.   "
244722|NCT01047358|"     This non-interventional study is to monitor use in real practice in Korea including adverse     events on Aromasin (Exemestane).   "
244723|NCT01047371|"     The purpose of this study is to evaluate patient related factors determining length of stay     in hospital after arthroplasty surgery.   "
244724|NCT01047384|"     Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage     following major orthopedic surgery often involves a large, deep incision with considerable     tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such     surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay     mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical     costs.      We design a prospective randomized study for postoperative pain control following total knee     arthroplasty.   "
244725|NCT01047397|"     The purpose of this study is to characterize the safety and efficacy of repeat doses of     compound 1278863A in subjects with anemia.   "
244726|NCT01047410|"     The aim of the present study is to compare the outcomes of standard care to the effects of     exercise alone, and exercise combined with nutrition counseling, on post-transplantation     weight gain and quality of life in renal transplant recipients (RTR). The primary outcomes     are post-transplantation weight gain and cardiometabolic risk, and quality of life regarding     physical functioning.      Our secondary outcomes are barriers and success factors regarding lifestyle intervention in     RTR, the barriers and success factors for intervention for healthcare professionals, and     long-term adherence to physical activity during the follow-up phase.   "
244727|NCT01047423|"     Cholesterol and blood pressure lowering tablets have been shown to be of benefit in patients     with established high blood pressure. High blood pressure is a very common medical condition     that can lead to vascular complications i.e. problems with the blood vessels in the body. One     way of detecting early changes in these blood vessels as a result of high blood pressure is     to measure their compliance/flexibility with a noninvasive technique known as ultrasound and     with a simple blood test. The investigators are trying to establish whether these early     changes in blood vessels can be significantly improved by the use of both a cholesterol and     blood pressure lowering tablet at an earlier stage than is currently advised. The     investigators hope that the early combination of these tablets will prove more effective than     the use of a blood pressure lowering tablet by itself and therefore possibly reduce the risk     of long term complications developing.   "
244728|NCT01047436|"     The purpose of this study is to compare the efficacy of Artemether Sublingual Spray     (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum     malaria, or children with uncomplicated malaria with gastrointestinal complications.   "
244743|NCT01052935|"     This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal     vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody     levels.   "
244744|NCT01052948|"     To assess the association between cabergoline and other dopamine agonists (DAs), and     symptomatic, diagnosed serious cardiopulmonary disorders, including:        1. Cardiac valve regurgitation        2. Diffuse Pleural/pulmonary thickening and pericardial and retroperitoneal fibrosis        3. Heart failure        4. Total, cardiac and respiratory mortality   "
244747|NCT01052987|"     This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period     2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate     the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to     evaluate the effect of allopurinol on tranilast PK and PD as measured by reduction in serum     uric acid levels.   "
244729|NCT01047449|"     Surgery for blocked arteries in the heart (coronary artery bypass grafting) can be     accomplished using veins from the leg sewn onto the heart to provide an alternate path for     blood flow, i.e. 'bypassing' the blockages. These veins themselves can block over time. This     may result in part simply from the trauma from the surgery, in other words, by removing the     vein from the leg and then sewing it to the heart. Another mechanism may be the abnormal     metabolic processes within the body responsible for the plaque build-up of the heart arteries     in the first place - this may lead to the blockages of the veins used for bypass. In the     present era of heart bypass surgery, this incidence of veins blocking remains high despite     advances in blood thinners and cholesterol medications. This study is designed to determine     whether two new interventions may potentially reduce the incidence of blockages in the veins     used for heart bypass surgery. One is a surgical technique significantly reducing the trauma     associated with removing the leg vein prior to use as a bypass graft onto the heart. The     second intervention is the use of a nutritional supplement before and after surgery which is     composed of fish oils. The study will recruit sufficient patients to provide strong and     relevant conclusions regarding both study questions. It will be highly applicable also     because it will include approximately 1,550 patients from approximately 50 hospitals across     many countries. We believe these techniques will result in significantly less vein blockages     in patients one year after heart bypass surgery.   "
244730|NCT01047462|"     The purpose of this study is to determine whether laparoscopic lavage changes the rate of     severe complications in patients with acute perforated diverticulitis who traditionally are     treated with primary resection.   "
244731|NCT01047475|"     This is a randomized, double-blind, parallel group, placebo-controlled study evaluate the     preliminary efficacy and safety of MB-6 (320 mg/capsule, 6 capsules tid) versus placebo in     addition to standard chemotherapy in the treatment of patients with metastatic colorectal     cancer.   "
244732|NCT01047488|"     Polyneuropathy of different etiologies is often associated with pain and the standard     treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this     study is that the combination of the gabapentinoid pregabalin and the antidepressant     imipramine will provide better pain relief than the single compounds alone.      This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin     300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include     60 patients and the treatment outcome will be pain intensity as measured by numeric rating     scales.   "
244733|NCT01047501|"     The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to     placebo in lowering high fasting triglyceride levels in patients with high risk for     cardiovascular disease and fasting triglyceride levels ≥ 200 and < 500 mg/dL.   "
244734|NCT01052818|"     The purpose of the study is to evaluate the association between the number of circulating     tumor cells and response to treatment in non small-cell lung cancer patients   "
244735|NCT01052831|"     This study will evaluate the effectiveness of naltrexone in reducing ICD symptoms in     Parkinson's disease patients taking a dopamine agonist.   "
244736|NCT01052844|"     Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic     surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy     induced emesis.      The purpose of this study is to determine whether the addition of gabapentin to dexamethasone     plus ondansetron increase the control of chemotherapy-induced nausea and vomiting.   "
244737|NCT01052857|"     The purpose of this study is to evaluate the efficacy and safety of acupuncture for the     induction of labor in pregnant women at the 40 weeks + 4 days of gestation.   "
244738|NCT01052870|"     Previous studies of finasteride treatment in women with hair loss have failed to show     positive results, yet, some women have responded anecdotally. Given that polymorphisms of the     androgen receptor gene which confer androgen sensitivity impact male response to finasteride     therapy, it was hypothesized that the same polymorphism in women may identify the group that     will respond. This study is designed to test the impact of finasteride therapy on hair loss     in postmenopausal women.   "
244739|NCT01052883|"     The purpose of this study is to compare the drug levels of darunavir obtained after     administration of a single administration of the 800 mg tablet (new formulation) to that     following administration of two 400 mg commercial tablets formulation when administered under     fed and fasted conditions to those also taking low-dose ritonavir. Darunavir is marketed for     the treatment of HIV. The short-term safety and tolerability of darunavir following     administration of a single 800 mg dose of darunavir given to healthy volunteers taking taking     low-dose ritonavir will also be assessed.   "
244740|NCT01052896|"     The purpose of this study is to evaluate the effectiveness of gabapentin on symptom control     in patients with defined functional dyspepsia refractory to conventional proton pump     inhibitor therapy and to compare these effects to that of placebo.   "
244741|NCT01052909|"     The purpose of this bioequivalence study is to compare a test Glimepiride 1 mg tablets of     Dr.Reddy's Laboratories Limited versus reference Amaryl 1 mg tablets of Aventis     Pharmaceuticals Inc in healthy subjects, under fasting condition.   "
244742|NCT01052922|"     Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for     screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual     screening rates by use of time-to-event analyses (also known as survival analysis). The     outcome variable of interest is the first time since randomization to have CRCS, either based     on FOBT, FS, or CS. Knowing screening rates will not only enable us to make comparisons     between groups, but also over time.      Ancillary Aims #2 and #3 We will recruit additional participants for two ancillary study     aims. First, we will enroll patients age 50-74 years using the same criteria as for the     primary SOS study, which includes neither history of colorectal cancer nor evidence of     life-limiting disease. Participants who return the questionnaire, consent and considered     eligible will be randomized to receive one of three different at-home fecal test kits. The     kits will be returned to the GH centralized laboratory, and participants will be informed     about lab results using standard GH pathways. Participants who have a test-positive will     receive a series of two follow-up surveys (first at 1-2 weeks post result and second at     4-months post result). A comparison group of test-negative results will be matched based on     selected criteria, and this group will also receive the follow-up surveys. Participants at     both time intervals who do not return the survey via mail will be called and if available,     administered the questionnaire via phone.   "
244751|NCT01053039|"     The primary aim of this study is to assess the impact of intrathecal morphine on     post-operative pain following instrumented fusion for degenerative lumbar spine disease.     Secondary objectives of this study aim to assess side effects, overall narcotic use and     duration of hospital stay following administration of intrathecal morphine.      Based on our literature review, we expect a significant improvement in pain scores and     functional status and minimal side effects with the use of intrathecal morphine. With     improved pain and function we would also expect shorter hospital stays in those patients     receiving intrathecal morphine.   "
244752|NCT01053052|"     Multi-center prospective comparison of fallopian tubal patency determination and uterine     evaluation interventions using legally marketed devices for their intended purposes, and     using each subject as their own control.   "
244753|NCT01053065|"     The impact on cardiovascular events achieved by statin therapy seems to be mostly     attributable to the cholesterol-lowering effect with a highly debated contribution of the     lipid-independent pleiotropic effects. However, a short-term benefit has been documented for     patients treated with statins in acute coronary syndromes and other clinical settings. These     observations strengthened the hypothesis of additional, so-called pleiotropic actions of     statins.      The investigators therefore sought to investigate how different lipid-lowering strategies     (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of     carotid plaque over a short-term period of three months. Specifically the investigators tried     and dissect the LDL-C lowering impact on plaque cellular composition as compared to the     lipid-independent contribution on plaque macrophage and smooth muscle cells.   "
244754|NCT01053078|"     Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly     and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is     left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe     hypoglycemia can lead to seizures, coma, and even death.      Some people with diabetes do not have early warning signs of low blood sugar. This condition     is called hypoglycemia unawareness. It happens when the body stops reacting to low blood     sugar levels and the person does not realize that they need to treat their hypoglycemia. This     can lead to more severe and dangerous hypoglycemia.      The purpose of this early study is to see if a drug called naltrexone should be studied more     in people with Type I diabetes and hypoglycemia unawareness. This study will show whether     naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic     resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the     brain when a person is experiencing hypoglycemia.   "
244755|NCT01053091|"     The purpose of this study is to investigate how exercise-base rehabilitation influences     circulatory functions in patients with diastolic heart failure (DHF).   "
244756|NCT01053104|"     To develop a system to manage side effects and adjust chemotherapy dose such that a patient     can receive their personal maximum tolerated dose.   "
244757|NCT01053117|"     To determine if a protocolized approach to converting hemodialysis central venous catheters     (CVC) to arteriovenous fistulae will improve rates of functioning AVF and decrease CVC use.   "
244758|NCT01053130|"     Weight loss surgery is the most effective weight loss treatment available, but the direct     effect on chronic kidney disease is less widely understood. Early research shows some     improvement in kidney function may occur and candidacy for kidney transplantation can be     improved with weight loss following surgery. To date, no randomised controlled trial has been     performed to examine the effect of weight loss surgery on the progression of chronic kidney     disease.      This randomised trial will allocate patients to either lifestyle modification with diet,     exercise and pharmacotherapy, or weight loss surgery to remove two thirds of the stomach     using the laparoscopic sleeve gastrectomy procedure. This study aims to evaluate weight loss     surgery vs lifestyle modification in patients with chronic kidney disease with estimated     kidney function of 20-60% and morbid obesity (BMI 35-45) in terms of kidney function,     cardiovascular disease risk factors and all-cause mortality.   "
244759|NCT01053143|"     The purpose of this study is to assess the safety and immunogenicity of one dose of A/H1N1     non-adjuvanted pandemic vaccine to support registration of the vaccine in India.      Primary Objective:        -  To describe the safety profile (injection site reactions and systemic events) of the          vaccine within 21 days following vaccination, and serious adverse events throughout the          study in all subjects      Secondary Objectives:        -  To describe the immune response to the vaccine 21 days after vaccination by          hemagglutination inhibition (HAI) testing in all subjects        -  To describe the antibody persistence 6 months after vaccination by HAI testing in all          subjects.   "
244760|NCT01058551|"     Single site study: The goal of the study is to determine the incidence of new onset atrial     fibrillation (AF) in patients with severe obstructive sleep apnea (OSA) syndrome through the     use of a Medtronic Reveal XT implantable Loop recorder (ILR). The ILR device is approved for     use in Canada, for the assessment of atrial fibrillation.   "
244761|NCT01058564|"     Evaluate a novel method of augmenting a weak Lower Esophageal Sphincter (LES).   "
244762|NCT01058577|"     In healthy subjects: Continuous monitoring of the glucose concentration in the skin by means     of a non-invasive glucose sensor during a glucose clamp when systematically changing the     blood glucose concentration (e.g. to hyperglycemia). Simultaneous frequent determinations of     serum electrolytes.   "
244778|NCT01058785|"     In this Phase II clinical trial the investigators will use four human non-small cell lung     cancer cell lines that have been previously established in tissue culture laboratory. The     investigators will gene modify these tumor cells in the laboratory to block their TGF-beta     secretion. The investigators will inject the genetically engineered cells as vaccines in     patients with stages II to IV non-small cell lung cancer. Our rationale for using other     people's tumor cells is that lung tumor cell lines belonging to different people have been     shown to share common characteristics that are recognized by non-self immune systems.   "
244779|NCT01058798|"     Neuroblastoma (NB) is the most common malignant tumor of infancy. Approximately 60% of NB     patients are clinically diagnosed as the stage IV disease and have a very poor prognosis with     a 5-year survival rate of no more than 30%. The mechanism underlying the tumorigenesis of NB     remains largely unclear. It has been suggested that the pathogenesis of NB is due to a     failure of differentiation or apoptosis of the embryonic NB cells.      Well-regulated glycosylation is essential for the normal development of the nervous system.     Altered expression of glycosyltransferases with resulting dysregulated glycosylation of     neuroblastic cells might lead to the development of NB. The     β1,4-N-acetylgalactosaminyltransferase III (B4GALNT3) exhibits GalNAc transferase activity to     form the GalNAcβ1,4GlcNAc (LacdiNAc or LDN) structure. The Drosophila B4GALNTA, homolog of     human B4GALNT3, has been suggested to regulate the neuronal development. By     immunohistochemical studies, we demonstrated that the expression of B4GALNT3 correlated well     with histological grade of differentiation in 87 NB tumor samples. In addition, positive     B4GALNT3 expression predicted a favorable patient's outcome. These evidences suggest that the     regulation of glycosyltransferases is critical for the development of NB.      To further explore the role of glycosyltransferases in the differentiation and development of     NB, we propose a 3-year project with the following 3 major aims:      Aim Ⅰ: Clarifying the effects of B4GALNT3 on NB cell behavior in vitro and in vivo. For     further understanding the effects of B4GALNT3 on NB cells, NB cells with stable     overexpression of B4GALNT3 are to be selected. Then NB cell phenotype and behavior changes     after overexpression of B4GALNT3 are evaluated by in vitro assays as well as by a nude mice     xenograft model. In addition, the expression of B4GALNT3 will be suppressed by siRNA, then     the response of NB cells to ATRA-induced differentiation is evaluated.      Aim Ⅱ: Clarifying the target proteins glycosylated by B4GALNT3 as well as their associated     downstream pathways in vitro and in vivo. The possible proteins glycosylated by B4GALNT3 are     evaluated by comparing differential protein expressions between B4GALNT3-transfected and     mock-transfected NB cells using proteomics analysis. NB tumor samples with low and high     B4GALNT3 expression levels are also subjected to proteomics analysis to explore the possible     target proteins glycosylated by B4GALNT3 in vivo. After identifying the target proteins     modified by B4GALNT3, the downstream pathways to affect NB cell differentiation will also be     evaluated.      Aim Ⅲ: Clarifying whether B4GALNT4, a family member of B4GALNT, plays a similar role as     B4GALNT3, as well as how the expression of these enzymes are controlled epigenetically in     human NB cell lines and tumor samples. The expression levels of B4GALNT4 in human NB samples     are evaluated by RT-PCR and immunohistochemistry. The methylation status of the promoter     sites of both B4GALNT3 and B4GALNT4 are examined in various NB cell lines as well tumor     samples. Furthermore, NB tumor samples exhibiting high and low B4GALNT levels are subjected     to microRNA array.      Altogether, our studies will not only establish the functional role of the family of     glycosyltransferases in the cell behavior of NB, but also illustrate how the expression of     glycosyltransferases are regulated epigenetically and how the glycosyltransferases affect NB     cell behavior. Therefore, our results might shed light to the oncogenesis of NB as well as     target therapy of NB.   "
244780|NCT01058811|"     Try to find lung cancer stem cells from primary culture of routine surgical resection of lung     cancer tissue including cancer cells and stroma cells, then characterization the established     cell lines, and compare the difference of stroma cells between tumor part and surrounding     part.   "
244763|NCT01058590|"     Obstructive sleep apnea syndrome (OSAS) is a common disorder in children (2-3%). OSAS in     turn, is associated with significant behavioral, learning, and heart problems.     Adenotonsillectomy (T&A, meaning the removal of tonsils and adenoids) is the most common     treatment for the problem .Diagnosis of OSAS in children is based on overnight     polysomnography (sleep study). Recent studies suggest that upper airway and systemic     inflammatory changes exists in school-age children and adults with OSAS, and that anti     inflammatory therapy can improve respiratory parameters during sleep and reduce adenoid size,     similar to surgery. However, there are no data in the literature on inflammatory changes in     infants with the disorder.      Healthcare resources utilization, a sensitive marker for diseases is consumed by young     children (<3y) with OSAS more then healthy children, from their first year of life We     hypothesize that infants and young children with OSAS present local inflammatory changes of     the airways as well as systemic inflammation (in the blood or urine) that contribute to the     learning, growing and heart associated medical problems. The Aims of the present study are to     characterize the local and systemic inflammatory changes of young children with OSAS, and to     evaluate their associated medical problems at diagnosis and after therapy (T&A) If indeed     inflammation is responsible for the development of OSAS at such a young age it should be     reduced following therapy (i.e. T&A). In such a case bio-markers may become a part of the     algorithms for diagnosis and follow up of such patients.   "
244764|NCT01058603|"     The aim of this study is to demonstrate the efficacy of a single embryo transfer at     blastocyst stage (Day 5) after co-culture on Autologous Endometrial Cell Culture (AECC)     versus transfer of a single embryo at Day 3 after culture in conventional medium. Efficacy     will be assessed in terms of clinical pregnancy rate 5 to 8 weeks after embryo transfer.   "
244765|NCT01058616|"     The study will evaluate the safety profile for LTX-315 a lytic-peptide that has shown effect     in animal models to kill cancer tumours when injected directly in to the tumour. The study     will also monitor the immunological response in the body after injection of LTX-315.   "
244766|NCT01058629|"     This is a multicenter study to evaluate the clinical performance of the SynergEyes A2 lens in     patients with refractive errors with or without astigmatism.   "
244767|NCT01058642|"     The primary purpose of this study is to evaluate the analgesic efficacy of ADL5747 in     participants with postherpetic neuralgia (PHN). The secondary objective of this study is to     evaluate the safety, tolerability, and pharmacokinetics of ADL5747.   "
244768|NCT01058655|"     Research has shown that anti-angiogenic agents can be effective therapies to treat cancer.     Anti-angiogenic agents target the blood vessels required for tumors to grow. Vascular     endothelial growth factor (VEGF) is one of the cell pathways used for this blood vessel     growth. When the investigators interfere with the VEGF pathway, the investigators inhibit     this blood vessel growth which is required by tumors. One of the study drugs being used,     tivozanib (AV-951), selectively interferes with the VEGF pathway. The second study drug being     used, everolimus (RAD001) interferes with the mTOR pathway. The mTOR pathway is another     pathway involved in blood vessel and tumor cell growth. By combining these two drugs the     investigators hope to slow or reverse tumor cell growth in patients whose tumors have become     resistant to other therapies for their disease.   "
244769|NCT01058668|"     The objective of this study is to evaluate the efficacy, safety, and tolerability of     cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes     associated with bipolar I disorder.   "
244770|NCT01058681|"     This study will evaluate the potential effects of a changing metabolic environment on GnRH     hypothalamic neurons, by performing studies of LH pulsatility (basal and during clamp     studies) in different groups of male subjects fed isocaloric and hypercaloric diets. The     participation of other gastro-intestinal tract hormones to these regulations will be     systematically evaluated.   "
244771|NCT01058694|"     The purpose of proposed research is to implement a randomized study that will allow us to     understand and address a number of key barriers to patient adherence as well as study the     effects of better adherence on health and socio-economic outcomes.   "
244774|NCT01058733|"     Background        -  Various kinds of interactive online communication systems have been introduced for          long-term diabetes management, and their importance in managing patients is increasing.          The investigators investigated the amount of physician time needed to maintain such a          system, and the investigators developed software to maximise the cost effectiveness.      Methods        -  The investigators conducted a prospective, randomised, controlled trial to investigate          the efficacy and safety of a semi-automatic response system (SARS) for online glucose          monitoring over a 24-week period of patients with type 2 diabetes. In the SARS group,          the SARS software filtered the recorded self-monitoring of blood glucose data          automatically to reduce the physicians' time, and the physicians managed patients          regularly but only manually in the control (manual) group. The investigators measured          the time spent by the physicians for online management and compared the HbA1c levels at          enrolment and follow-up.   "
244775|NCT01058746|"     The purpose of this study is to help us learn what the best amount of fluid is that patients     should receive during pancreas surgery. Patients will receive either the liberal fluid amount     for this surgery or a restricted fluid amount.      Both amounts of fluid have been used safely in patients having similar surgeries. These     amounts have not been compared in pancreatic surgery. The fluids regimens that will be given     are not experimental.      This study will compare patients in the liberal and restricted fluid groups in terms of the     nature of any surgical complications (problems)and recovery from surgery, including length of     hospital stay.   "
244776|NCT01058759|"     Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy     or in combination with Enoxaparin in patients aged older than 18 years with locally advanced     or metastatic non-small cell lung cancer (stadium IIIb/IV), a phase III study. Study     hypothesis: Increase of progressive free survival from 5 to 7.5 months.   "
244777|NCT01058772|"     The purpose of this study is to determine whether, in Gestational Diabetes Mellitus (GDM)     pregnancies, induction of labour at 38-39 weeks of pregnancy is superior to expectant     management in terms of maternal and neonatal outcomes.   "
244802|NCT01060228|"     The purpose of this study is to evaluate the effect of valproic acid (VPA) on the     pharmacokinetics (blood levels) of a single oral dose of an extended-release formulation of     paliperidone in healthy male volunteers.   "
244781|NCT01058824|"     To assess the relative bioavailability of two different batches of Frademicina® drug product,     containing 500 mg lincomycin hydrocloride, manufactured by Pfizer Laboratories Ltd. The     formulations' comparative bioavailability after oral administration will be assessed based on     the statistical comparisons of the relevant pharmacokinetic parameters, obtained from the     drug concentrations in the blood. The lincomycin hydrocloride concentration will be measured     by a proper and validated analytical method.   "
244782|NCT01058837|"     No clinical trial that has examined the role of implantable cardioverter defibrillator (ICD)     therapy in the prevention of Sudden Cardiac Death (SCD) has provided outcome data for longer     than a few years. The NHLBI sponsored and placebo-controlled Sudden Cardiac Death in heart     Failure Trial (SCD-HeFT) conducted from 1997 to 2003 had the largest number of patients and     the longest average follow-up at 45.5 months. This study changed the national reimbursement     policy for ICD therapy and remains the reference point for all other ICD evaluations in     patients with congestive heart failure from ischemic or non-ischemic systolic dysfunction.     Despite the outcome, the role of ICD therapy in the management of patients with heart failure     has been questioned because of four principal concerns: numbers needed to treat to save a     life, lead integrity over time, the negative consequences of shock therapy, and the cost of     therapy. The purpose of this trial is to track down the remaining patients for a one-time     follow-up regarding key outcome data.   "
244783|NCT01058850|"     This is a research study of patients with diffuse intrinsic pontine gliomas. We hope to learn     about the safety and efficacy of treating pediatric diffuse intrinsic pontine glioma patients     with the EGFRvIII peptide vaccine after conventional radiation.   "
244784|NCT01058863|"     This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to     help adult and adolescent subjects 12 years of age and older with persistent asthma to     improve lung function.   "
244785|NCT01058876|"     The investigators' general hypothesis is that African-Americans (AAs) smoke more for positive     reinforcement from nicotine with a peak-seeking pattern of smoking (smoking individual     cigarettes more intensively with greater intake of nicotine and tobacco smoke toxins), while     whites smoke more for negative reinforcement with a trough-maintaining pattern (avoiding     withdrawal by maintaining more consistent nicotine levels throughout the day by means of a     more regular smoking pattern). We, the investigators, believe that these patterns are linked     to identifiable racial differences in nicotine pharmacology.      For this study we hypothesize that if AAs behave more like nicotine peak-seeker while     whites behave more like nicotine trough-maintainers, that AAs will respond to switching     from regular to low nicotine yield commercial cigarettes by smoking each cigarette relatively     more intensively with a relatively smaller increase in daily cigarette consumption     (cigarettes per day or CPD) as compared to whites.   "
244786|NCT01060020|"     Pulmonary hypertension is common in patients with aortic stenosis and is associated with     worse operative and long-term outcomes. Sildenafil has been shown to reduce pulmonary artery     pressure and improve exercise performance in patients with left-sided heart failure, but this     has not been tested in patients with aortic stenosis. We hypothesize that Sildenafil will     produce a clinically significant decrease in pulmonary artery pressure in patients with     severe aortic stenosis. The dose of Sildenafil that produces a significant decrease in     pulmonary artery pressure will be safe and well tolerated in patients with and without a     depressed ejection fraction.   "
244788|NCT01060046|"     The purpose of this study is to investigate what happens to biologic mesh in the body over     time on a molecular level. To date, it is not known what agents, enzymes, or proteins are     interacting at the implantation site that contributes to mesh remodeling and/or degradation.     Investigators on this project will identify patients with previously placed mesh who are     needing reoperation on the same site and take a biopsy of the mesh during the normal course     of surgery. Basic data surrounding the surgical procedure will be collected. The mesh samples     will be analyzed for enzymes and proteins and examined histologically for processes that     signify remodeling and/or degradation. Control patients will undergo biopsy of abdominal     fascia at laparoscopic trocar sites in a manner that will not affect the outcome(s) of their     procedure or other risk to the incision site.   "
244789|NCT01060059|"     Although the efficacy and safety profile of exenatide has been well established, few data     exist on the real world results of exenatide treatment in specific populations and clinical     settings. This study is intended to fill this gap through observing and collecting     prospective data from a population of Italian patients initiating treatment with either     exenatide or basal insulin formulations after failure to achieve glycemic control with oral     antihyperglycemic agents (OHA).      Observational studies represent noninterventional research; therefore, this study does not     involve randomization of patients to particular comparator arms or therapies. The term     noninterventional means that the healthcare providers decisions regarding the proper     treatment and care of the patient are made in the course of normal clinical practice.     Patients enrolled in this study are enrolling for the collection of their data on     observations made during normal clinical practice.   "
244790|NCT01060072|"     This study is being conducted to compare the safety and efficacy of loteprednol etabonate to     vehicle for the treatment of postoperative inflammation and pain following cataract surgery.   "
244791|NCT01060085|"     The primary objective of this study is to compare the diagnostic accuracy of Digital Breast     Tomosynthesis (DBT) versus that of Contrast Enhanced Magnetic Resonance Imaging (CEMRI) in     determining the size of breast cancer preoperatively.      Secondary objectives include:        1. Comparing the operating characteristics of each combined imaging protocol with respect          to the reference standard, i.e. histopathologic assessment, of additional non-index          lesions.        2. Comparison of re-excision rates based on estimated disease extent from adjunctive CEMRI          vs. adjunctive DBT.        3. Evaluation of patient satisfaction with regard to the adjunctive modality (DBT vs.          CEMRI).   "
244800|NCT01060202|"     This study will observe the degree of the quality of life in non-transplant candidate     patients with multiple myeloma before and after bortezomib administration by using EORTC-QLQ     C30 (European Organization for Research and Treatment of Cancer Quality of Life     Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions). Both tools are validated research     instruments used to measure the quality of life in cancer patients and consequently will     provide fundamental data regarding the quality of life in patients with multiple myeloma by     analyzing factors that affect the quality of life.   "
244792|NCT01060098|"     Inflammatory arthritis particularly rheumatoid arthritis, psoriatic arthritis and ankylosing     spondylitis are potentially disabling conditions which cause joint pain, swelling and     deformity and treatments are aimed at preventing these complications. Although treatment has     improved with the advent of antiTNFalpha therapies, up to 30% of patients fail to respond to     this treatment and in others, treatment is associated with significant side effects. The     precise mechanisms of this remain unclear. In addition, there are no sensitive methods     available to monitor or predict disease response to treatment aside from testing inflammatory     markers in the blood. Understanding the mechanism of action and what governs response to     antiTNF therapy will allow development of more specific therapies for inflammatory arthritis.     Work in animal models of rheumatoid arthritis has characterised a novel cell type, Th17     cells, important in the inflammatory cascade which are affected in a particular way by     antiTNF therapies and may underpin their mechanism of action and side effects. We aim to     translate these findings into patients with rheumatoid arthritis and other conditions treated     with anti-TNF therapy, such as psoriatic arthritis and ankylosing spondylitis. Patients from     rheumatology clinics within NHS trusts will be recruited. We will correlate disease activity     assessed by clinical parameters, ultrasonography and questionnaires with biomarkers in the     blood and target tissues, such as synovium and skin.   "
244793|NCT01060111|"     The purpose of this study is to investigate the adequacy (reasonably good) of topiramate     therapy (medicine or medical care given to a participant for a disease or condition) in     prevention of migraine (type of severe headache that occurs periodically and is often     associated with nausea, vomiting, and constipation or diarrhea) by comparing standard     titration (slow increase in drug dosage, guided by patient's responses) therapy to slow     titration therapy and slow titration therapy boosted by the concurrent use of propranolol in     participants with migraine with or without aura (having to do with the ear) for more than or     equal to 2 attacks per month.   "
244794|NCT01060124|"     The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic     System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so     the drug will enter the body through the skin) treatment in cancer participants of Korea with     inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and     participant's satisfaction.   "
244795|NCT01060137|"     The purpose of this study is to evaluate the usefulness of fentanyl matrix by assessing     patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and     a breakthrough pain treatment to lung cancer patients who complain of pain. Fentanyl matrix     is designed to deliver medication at a nearly constant amount per unit time into the body     through the skin for 3 days (72 hours).   "
244796|NCT01060150|"     The purpose of this study is to evaluate the efficacy, tolerability and effects of Osmotic     Release Oral System (OROS) methylphenidate hydrochloride (HCl) on learning skill changes in     Korean participants with Attention-Deficit Hyperactivity Disorder (ADHD).   "
244809|NCT01060319|"     We hypothesize that all human malignancies harbour a subpopulation of tumor initiating     cells/cancer stem cells (CSCs) that drives tumor development and potentially recurrence or     metastasis of the disease. The primary aim of this study is to develop strategies for     prospective isolation/enrichment of CSCs from human tumors of different tissue origins. In     addition, we will characterize the signaling pathways and/or tumor specific antigens that are     specific for CSCs, in order to specifically target these CSCs as the endpoint of this study.   "
244825|NCT01060527|"     Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder haracterised by     abdominal pain or discomfort associated with altered bowel habits,while the mechanism is     still not understood.Recent advances have conceptualized the faecal supernatants of     diarrhoea-predominant IBS have a substantially higher serine protease activity, while in     china,almost no studies have reported about protease activity in IBS.   "
244797|NCT01060163|"     The use of platelet aggregation inhibitors, including aspirin and clopidogrel(CPDG), has     become a standard management strategy for patients with acute coronary syndrome. On this     background, an increasing percentage of patients presenting for surgical coronary     revascularization is the subject to irreversible platelet inhibition.      Investigations on the effect of antiplatelet treatment on postoperative bleeding after     cardiac surgery have shown that patients treated with antiplatelet agents until surgery have     increased postoperative bleeding, and also an increased need for transfusions of blood     products. As a result of the antiplatelet effect of clopidogrel, the frequency of serious     bleeding complications has increased significantly, as seen in patients requiring coronary     artery bypass grafting(CABG), especially when they received clopidogrel until surgery.      Tranexamic acid(TA) is a widely used antifibrinolytic agent, and is a promising substitute     for aprotinin when the latter has seceded in 2007.The release of plasmin during     cardiopulmonary bypass(CPB) activates fibrinolysis and may contribute to platelet     dysfunction. Pharmacological inhibition of the fibrinolytic system may therefore ameliorate     platelet dysfunction and fibrinolysis after CPB and decrease postoperative bleeding.     Tranexamic acid prevents plasmin formation and inhibits fibrinolysis.      Concerning the cessation of aprotinin and the increasing proportion of patients with     persistence on clopidogrel until their surgery, evolutional work is expected, especially in     the eastern population.      The purpose of this study is to assess the effect of tranexamic acid in patients with     clopidogrel and asprin ingestion until surgery. The investigators working hypothesis was that     tranexamic acid would lower postoperative blood loss and transfusion requirements in these     patients and would attenuate bleeding complication of antiplatelet therapy.   "
244798|NCT01060176|"     Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has     seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in     cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The     current study includes patients receiving valvular replacement and coronary artery bypass     surgery. Different dosage of tranexamic acid is delivered and blood loss, transfusions and     clinical outcomes are recorded. The study hypothesis is that tranexamic acid could reduce     blood loss and allogeneic transfusion in cardiopulmonary bypass cardiac surgery. Furthermore,     tranexamic acid could decrease inflammatory reaction in cardiac surgery.   "
244799|NCT01060189|"     Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic     transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but     expensive, and has been proved to link to higher risks of serious side effects including     renal problems, myocardial events, and strokes in patients undergoing CABG. After the     secession of aprotinin in 2007, a marked increase of blood loss and transfusions in cardiac     surgery took place. An effective and secure hemostatic agent is badly needed. Ulinastatin,     urinary trypsin inhibitor(UTI), is a secreted Kunitz-type protease inhibitor with a wide     inhibition spectrum, including plasmin. Limited studies offered clues to its antifibrinolytic     effect. Tranexamic acid has been applied for years with convinced efficacy and safety. The     objective of the study is to evaluate the hemostatic and anti-inflammatory effect of     ulinastatin and tranexamic acid in cardiac surgery.   "
244803|NCT01060241|"     This project will test the effectiveness of an Internet based glucose monitoring system on     the A1C levels of patients with type 2 diabetes. All of the patients are given a meter and     test strips to test their blood glucose levels, however, half of them will be required to     also upload their meter onto the Internet which can then be viewed by their endocrinologist.     The doctor can then send a message back to the patient and comment on the readings. The     effect of the ongoing communication will be measured by the changes in the glucose levels     (HbA1C) over 3 and 6 months.   "
244804|NCT01060254|"     The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of     JNJ-42160443 compared to placebo in patients with moderate to severe, chronic bladder pain     from interstitial cystitis and/or painful bladder syndrome.   "
244805|NCT01060267|"     Objectives:      Blood in stomach & oesophagus in patients with variceal bleeding often obscures the     endoscopic view & makes endoscopic intervention difficult to perform. Erythromycin, a motilin     agonist induces gastric emptying. The aim of this study was to assess the effect of     Erythromycin on endoscopic visibility and its outcome.   "
244806|NCT01060280|"     A cluster, randomized, controlled clinical trial, where the hypothesis is that Group GDS and     Individual GDS are effective in the treatment of nonspecific low back pain. The clusters will     be the participating physiotherapy departments in primary care who treat patients with low     back pain. In each physiotherapy department there will be 3 groups: education group, Group     GDS and Individual GDS. Patients will be followed for 12 months. Variables will be:     demographic,intensity of pain, disability, quality of life, patient satisfaction, medication     intake for current episode, non-pharmacologic treatment for current episode, co-morbidity,     diagnostic tests, sick leave, and habitual physical activity. The questionnaires to be used     are: Roland Morris Disability Questionnaire, PI-NRS, VAS, SF-12 and EQ-5d.   "
244807|NCT01060293|"     The aim of this study is to compare the effects of 1) high-dose furosemide, 2) low-dose     furosemide, and 3) low-dose furosemide combined with low-dose dopamine on diuresis, clinical     status, renal function, electrolyte balance, length of stay, and 60-day post-discharge     outcomes in patients hospitalized with acute decompensated heart failure.   "
244808|NCT01060306|"     PONTINA aims at assessing by optical coherence tomography the neointimal coverage of the     biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug     elution and polymer biodegradation (6 months), at one month after this time-point (7 months)     and, as a comparator, of its bare metal stent counterpart (Gazelle stent) at 1 month after     implantation.   "
244824|NCT01060514|"     The purpose of this study is to determine the highest dose of Vinorelbine and Pazopanib that     can be given together without causing severe side effects. Also, this study will evaluate     what effects (good and bad) that the treatment has on patients and their cancer.   "
244845|NCT01060787|"     Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants   "
244810|NCT01060332|"     Diabetic Mellitus is the fifth cause of death by the report of Department of Health in 2008,     and it often cause the severity of other chronic diseases. Neuropathy, retinopathy and     renopathy are the most prevalent complications of DM, and they often influence the quality of     life.      300 patients with Diabetic neuropathy will be recruited in Taichung Veterans General Hospital     endocrine and metabolism clinics. Body Constitution Questionnaire(BCQ), Diabetes Impact     Measurement Scales(DIMS), Short Form -36(SF-36) will be asked to filled up, neurological     examination (NE), AC sugar, HbA1c, lipid profiles, liver and kidney functions will be     measured in order to evaluate the correlation between body constitution and quality of life     on patients with diabetic complication.   "
244811|NCT01060345|"     The purpose of this study is to find molecular signs (biomarkers) to better understand the     role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed     ductal carcinoma in situ (DCIS).   "
244812|NCT01060358|"     The purpose of this study is to verify the existence of neuromuscular neutral zones(NNZs) in     humans, and develop non-invasive techniques to measure intervertebral kinematics of the     lumbar spine. The results will be used to accurately quantify NNZs in humans, and provide a     foundation for clinical trials on low back pain patients using this methodology.   "
244813|NCT01060371|"     Spinocerebellar ataxias (SCA) are genetic neurological diseases that cause imbalance, poor     coordination, and speech difficulties. There are different kinds of SCA and this study will     focus on types 1, 2,3, and 6 (SCA 1, SCA 2, SCA 3 , also known as Machado-Joseph disease and     SCA 6). The diseases are rare, slowly progressive, cause increasingly severe neurological     difficulties and are variable across and within genotypes. The purpose of this research study     is to bring together a group of experts in the field of SCA for the purpose of learning more     about the disease.      The research questions are:        1. How does your disease progress over time?        2. What are the best ways to measure the progression?        3. Do some genes, other than the gene that is abnormal in your disease, have any effect on          the way the disease behaves?      This is a nationwide study and we expect that 800 patients will participate all over the USA.     The participants will be in the study for an indeterminate period of time. Study visits will     be done every 6 or 12 months depending on the participating site.   "
244814|NCT01060384|"     The purpose of this trial is to investigate the efficacy (how well the drug works) of     ofatumumab and lenalidomide in patients with lymphoma and to investigate if any possible     unwanted side effects may occur. The purpose of the Phase I portion of this trial will be to     determine the maximum dose of these medications that can be given with minimal side effects.   "
244834|NCT01060644|"     The present study describes and evaluates the surgical protocol for sinus mucosal lining     elevation of the maxillary sinus for Dental Implant Insertion without Bone grafting     Underneath the Sinus Membrane.   "
244835|NCT01060657|"     To evaluate the clinical values of using dose reduction techniques in 64-row multi-slice CT     coronary artery imaging.   "
244836|NCT01060670|"     The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal     Regeneration Template for the treatment of diabetic foot ulcers located distal to the     malleolus in subjects with diabetes mellitus, neuropathy, and without significantly     compromised arterial circulation.   "
244837|NCT01060683|"     The purpose of this study is to evaluate the accuracy of continuous SpHb measurement (     Rainbow DCI, Masimo, Irvine Ca, USA) compared to the current method of monitoring (blood     sampling), both during phases of hemoconcentration and hemodilution.   "
244815|NCT01060397|"     Heavy alcohol consumption leads to various health problems and is now recognised to be an     important public health problem. This is evidenced by the huge media attention recently     focused on the use and misuse of alcohol, particularly by younger patients. At least 1 in 20     of the population in the UK are physically and psychologically dependent on alcohol. This not     only has consequences for the physical and psychological well-being of these patients, but     has adverse consequences for their family, work life and society in general. Current     treatments are mostly delivered in specialist units, which are few in number meaning that few     patients get access to these services. This leads to a vicious cycle which results in     multiple hospital admissions, ineffective treatments and continual drinking. It is therefore     vital the investigators develop alternative effective treatments for these patients which can     interrupt this vicious cycle.      In patients who drink heavily, but are not yet alcohol-dependent, a treatment called brief     intervention can help reduce overall alcohol consumption, and improve health and wellbeing.     However, whether a similar intervention can help alcohol-dependent patients has not yet been     established.      In this study, the investigators aim to identify, treat and support alcohol-dependent     individuals. Using an enhanced form of BI (termed extended brief intervention, EBI) as the     basis of clinical care, the investigators will undertake a randomised trial comparing EBI     with usual clinical care. The investigators will use various clinical and behavioural     measures to assess the effectiveness of this treatment. The investigators will also be asking     patients how they felt, and what they think of their treatment and the professionals     delivering that treatment. If EBI is shown to be effective and is not too costly, it could     provide a national framework for treatment of alcohol-dependent patients. This could     potentially improve both the opportunities to access treatment and the choice of treatments     available to patients.      The investigators hypothesis is that Extended Brief Interventions (EBI) delivered to     alcohol-dependent patients in a hospital setting by an Alcohol Specialist Nurse (ASN) will be     effective in reducing overall alcohol consumption and improving the standard measures of     alcohol dependence.   "
244816|NCT01060410|"     The purpose of this study is to investigate the relationship between the side effects of     cyclophosphamide in the treatment of systemic lupus erythematosus (SLE) in Han Chinese and     the genetic polymorphisms of drug metabolizing enzymes and pharmacokinetics of     cyclophosphamide.   "
244817|NCT01060423|"     The primary objective of this study is to evaluate the efficacy of Irinotecan Beads in     combination with intravenous cetuximab versus intravenous irinotecan in combination with     intravenous cetuximab in the treatment of patients with unresectable liver metastases from     colorectal cancer.      Secondary objectives are safety and tolerability of hepatic chemoembolization and the     question if the addition of aprepitant to standard antiemetic prophylaxis in patients treated     by hepatic chemoembolization is safe and will reduce the rate of acute and delayed nausea and     emesis.   "
244818|NCT01060436|"     The purpose of this pilot study is to find out whether successful treatment of obstructive     sleep apnea makes people look less sleepy, for example by reducing swelling or dark circles     under the eyes. In addition, this study will help determine whether facial photographs may be     used to help identify patients who should be tested for sleep apnea and daytime sleepiness.   "
244819|NCT01060449|"     Cardiac resynchronization therapy (CRT) is a device implanted to improve the function of some     people's hearts. CRT involves the placement of 3 wires in the heart through a vein near the     front of your left or right shoulder into three pumping chambers of the heart, the most     important being the left lower chamber, left ventricle (LV).   "
244820|NCT01060462|"     The purpose of this observational study is to examine the rate at which elevated body     temperature (fever) is relieved by an itraconazole injection administrated to patients     experiencing neutropenic fever . A neutropenic fever is an elevated body temperature that     occurs at a time when the patient's white blood cell count is low. White blood cells aid the     body's normal defenses against infection, so a fever during this period might make it     difficult for the patient to fight infections.   "
244821|NCT01060475|"     LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.   "
244822|NCT01060488|"     The aim of the study is to determine the specificity and sensitivity of the combined growth     hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly     probable adult growth hormone deficiency (AGHD) and subjects who were probably free of AGHD.   "
244823|NCT01060501|"     The primary objective was to improve adjuvant 5-FU chemoradiotherapy in resectable rectal     cancer. The investigators hypothesis was that modulation of 5-FU by addition of either FA or     INF-alpha may increase overall survival.   "
244826|NCT01060540|"     In this 6-month randomized, controlled trial, we examined whether providing participants with     genetic test results and counseling regarding their risk for type 2 diabetes would motivate     them to improve their health behaviors and lose weight to reduce their diabetes risk. We     hypothesized that participants who received conventional diabetes counseling plus genetic     test results and counseling would have at least 6 lb greater weight loss at 3 months than     participants who received conventional diabetes counseling without genetic test results.   "
244827|NCT01060553|"     The purpose of this study is to examine if acupuncture improves Post-Traumatic Stress     Disorder symptoms among veterans who participated in Operations Enduring Freedom and Iraqi     Freedom. This study will also examine the degree of veteran acceptance for acupuncture.   "
244828|NCT01060566|"     The objectives of this study are to evaluate the effects of VX-770 on Midazolam and     Rosiglitazone, and the effect of Fluconazole on VX-770.   "
244829|NCT01060579|"     A 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in     treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The     ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be     different from that of an active control.   "
244830|NCT01060592|"     Subjects having a gastric band fitted will have the first band adjustment done at surgery.     The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter,     band adjustments will be made using an adjustment chart, created at surgery, which shows     stoma size versus band fill, to make adjustments in the normal follow-up visits. It is     hypothesized that an early adjustment at surgery will promote earlier weight loss, and result     in fewer band adjustments being required in the first year after surgery.   "
244831|NCT01060605|"     Numerous changes to the original Edmonton protocol have been proposed in the attempt of     improving the still unsatisfactory long-term function of ITA. Rapamycin may blunt the early     inflammatory response to islet transplantation in the liver, thus favoring islet engraftment.      Aim of the investigators study was to evaluate the effect of a pre-transplant treatment with     rapamycin in patients with type 1 diabetes receiving islet transplant alone and     immunosuppression according to the Edmonton protocol.   "
244832|NCT01060618|"     The summary of the Study is to compare two methods in order to predict how the 1-HIV will use     a co-receptor: the use of an accredited test (TROFILE ESTA®) and the viral response to a CCR5     antagonist in the short term.   "
244833|NCT01060631|"     The purpose of this study is to assess whether BIS values at return of consciousness are     different in patients with or without brain tumors.   "
244838|NCT01060696|"     The infertility patients who are performed saline infusion sonohysterography (SIS) for     studying the pathology inside the uterine cavity has pain. From pilot study the pain score is     6.80. It will have more benefits if we can manage this procedure with less or no pain. Many     studies have tried to decrease pain such as types of catheter, intrauterine lidocaine     infusion. Some have real effects but no study with oral Mefenamic acid or Hyoscine before the     procedure.The drugs are safe and easy to administration and chief.   "
244839|NCT01060709|"     Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation     prior to current sedation monitoring practices in order to prevent hypoxemia in sedated     patients undergoing colonoscopies?   "
244840|NCT01060722|"     This study aims to examine the safety, tolerability and pharmacokinetics of a long-lasting     Human Growth Hormone (MOD-4023) in healthy volunteers after a single subcutaneous injection     at escalating doses.   "
244841|NCT01060735|"     Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily     vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun     exposure these doses are seldom able to achieve 25(OH)D optimal serum levels.      We hypothesize that larger doses of vitamin D are needed to be supplemented to all women     during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin     D and bone reserve as well on offspring vitamin D and bone status at birth and possible     further on.      The aim of the present study is to compare vitamin D and bone status of infants born to     mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the     third trimester of pregnancy.   "
244842|NCT01060748|"     This is a research study about an experimental (investigational) vaccine called ACE527.     ACE527 is a vaccine that is being made to prevent disease from a germ called enterotoxigenic     Escherichia coli (ETEC). This germ causes diarrhea, largely in children living in developing     countries and in travelers to those countries. One purpose of this study is to see if the     vaccine is safe and develops an immune response. Another purpose is to see if it prevents     people from getting sick when exposed to the ETEC germ. This ETEC germ is also experimental     (investigational).   "
244843|NCT01060761|"     The objective is to investigate a rehabilitation program (supportive conversations and a     rehabilitation course for cancer patients and their relatives together).      The study evaluate the effect of the program compared to no intervention (usual care)   "
244844|NCT01060774|"     This study is testing a local anesthetic (numbing medicine) to suppress pain. Bupivacaine and     lidocaine are FDA approved local anesthetics that may decrease pain following surgery.     Patients will receive either 2% lidocaine, 0.5% bupivacaine, or placebo with epinephrine     1:200,000 as a numbing medicine at the end of root canal surgery. Small pieces of gum will be     taken before and after surgery and 2 days later to analyze chemicals that may be related to     pain sensation.   "
244846|NCT01060800|"     Duke University Medical Center is investigating the hereditary basis of Chiari type I     malformations with or without syringomyelia (CM1/S). Our research is aimed at learning if     CM1/S is indeed caused by factors inherited through the family and, if so, which genes are     involved.   "
244847|NCT01060813|"     This is a pilot study including 20 cirrhotic patients that will be randomized to receive     during 3 months leucine vs leucine plus a programme of physical exercise specially designed     for cirrhotic patients. The hypothesis is that physical exercise in cirrhotic patients could     increase muscle mass (and therefore glutamine synthetase activity leading to a higher blood     ammonium clearance) and quality of life. Safety of physical exercise in cirrhotic patients     will be strictly assessed.   "
244848|NCT01060826|"     Acute pancreatitis is the most frequent (5-10%) and severe complication after endoscopic     retrograde cholangiopancreatography (ERCP), that could require of surgical intervention and     lead to death. A double- blind study designed to evaluate if the treatment with somatostatin     in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for     4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted     to ERCP will be randomized in two groups of treatment, one will receive somatostatin and     another placebo. The main aim of this study will be the incidence of acute post-ERCP     pancreatitis and secondary objectives will be identify sub-groups of patient with high risk     to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the     exploration. The study will include 510 patients submitted to an ERCP during a period of 3     years.   "
244849|NCT01060839|"     -  In the formative stage of the project, we have investigated through qualitative and          quantitative studies to identify a potential intervention to promote partner referral          for sexually transmitted patients in Bangladesh.        -  We conducted a quasi-randomised trial to evaluate if single session counseling is          effective in improving partner referral for patients with sexually transmitted          infection.   "
244850|NCT01060852|"     The purpose of this study was to determine whether a media literacy education program taught     be teacher to late elementary school students (grades 3-5) positively affected students'     critical thinking skills and substance use-related health outcomes.   "
244851|NCT01060865|"     Almost 50% of hypertensive patients remain uncontrolled. Clinical decisions are mostly based     on office blood pressure,despite the fallacies of this method of measurement. Other reasons     for not achieving blood pressure targets are lack of 24-hr efficacy and tolerability of     existing anti-hypertensive drug classes. Aliskiren (Rasilez®) is a new antihypertensive drug,     given once a day.      The purpose of the REALITY study-[tREAtment of essentiaL hypertension with rasIlez.     evaluation of different methods of blood pressure measurements - efficacy and safeTY     evaluation -] is to evaluate the efficacy, and tolerability of aliskiren in a real life     setting. The efficacy of the drug will be evaluated using 24 hour ambulatory blood pressure     monitoring (ABPM). Results will be compared with office, nurse or self blood pressure     monitoring. This comparison will allow to decide which follow-up technique is better for     those hypertensive patients.   "
244852|NCT01060878|"     A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating     early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified     Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and     well tolerated in this study and demonstrate therapeutic benefit in this patient population.   "
244877|NCT01061203|"     Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with     grass pollen allergy   "
244853|NCT01060891|"     Nosocomial infections have become a major health problem. They induced important use of     antibiotics which is a preponderant factor for the development of bacterial resistance. The     multi-resistance to antibiotics affects primarily Gram-negative bacteria. Some strains (as     Acinetobacter or Pseudomonas) have become resistant to almost all antibiotics currently     available, and the use of old molecules as Colistin may be the only alternative. However,     there are few reliable data about Colistin and its PK characteristics. These data are     essential to optimize its administration. The aim of the present study is to evaluate the     pharmacokinetics of Colistin and its prodrug, colistimethate (CMS) after intravenous     administration of Colistimethate alone or combined with inhaled Colistin in severely ill     patients infected with multiresistant gram-negative bacteria   "
244854|NCT01060904|"     The purpose of this study is to assess the safety profile of brentuximab vedotin in     combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin     lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the     maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of     brentuximab vedotin in combination with frontline therapy.   "
244855|NCT01060917|"     Continuous monitoring of the skin tissue glucose concentration on two different study days     using glucose sensors that work on the principle of impedance spectroscopy, with systematic     alteration of the blood glucose concentration using the glucose clamp technique in healthy     subjects and subjects with type 1 diabetes. Simultaneous determination of electrolyte     concentrations in the blood by taking frequent blood samples.   "
244856|NCT01060930|"     Exposure to combustion-derived fine particulate air pollution is associated with     cardiovascular mortality and morbidity. In previous studies, exposure to diesel exhaust (a     major constituent of urban particulate air pollution) has been shown to impair two important     functions of the vascular endothelium: vascular vasomotor function and endogenous     fibrinolysis. Our subsequent studies suggest this impairment of vascular function is mediated     by a reduction in nitric oxide bioavailability. In this study we aim to investigate the     cardiovascular responses to systemic nitric oxide synthase inhibition following exposure to     dilute diesel exhaust.   "
244869|NCT01061099|"     This is a study to evaluate the safety and effectiveness of repeated Mesenchymal Stromal     Cells (MSC) infusions to patients with Type II or III osteogenesis imperfecta (OI).      Participants will receive MSC infusions approximately every 4 months to complete a total of 6     infusions over 20 months. Participants will be followed for 4 months post their last MSC     infusion.   "
244882|NCT01061268|"     To evaluate the safety and efficacy of BLINK™ tears compared with NO topical artificial tear     use in improving subject's visual performance and reduce ocular symptoms of discomfort in     subjects who have undergone cataract surgery implanted with a Tecnis™ diffractive multifocal     intraocular lens (IOL).   "
244857|NCT01060943|"     -  Investigational Device : TheraFill® (Atelocollagen Dermal Filler)        -  Title : A Randomized, Multicenter, Prospective and Paired Comparison of the Efficacy and          Safety of TheraFill® versus KOKEN for 3months on Nasolabial Folds        -  Sites and investigators :             -  The Catholic University of Korea. Kangnam St. Mary's Hospital (#505, Banpo-dong,               Seocho-gu, SEOUL)             -  The Catholic Univ. of Korea Holy Family Hospital (#2, Sosa-dong, Wonmi-gu,               Bucheon-si, Gyeonggi-do)        -  Objective : To compare the non-inferiority of TheraFill® with KOKEN for evaluation of          the efficacy and safety on Nasolabial Folds for 3months        -  Clinical Study Method : Seventy-three subjects who agree to voluntarily participate in          the clinical study are randomized to treatment with TheraFill (porcine atelocollagen          filler) and KOKEN (bovine atelocollagen filler) in the contralateral fold(NFL). The          subjects shall regularly visit the hospital 5 times or more and if subjects take          touch-up treatments, the number of visit times will be increased. Treatments shall be          repeated at 2 weeks intervals, as required, to achieve Optimal cosmetic result.          Outcomes shall be evaluated by blinded investigators, investigators and subjects at 2,4          and 12 weeks after baseline.        -  Subjects : The target number of subjects is 62subjects, and 73 subjects are selected in          the screening period in consideration of 15% of dropout rate.   "
244858|NCT01060956|"     The purpose of this study is to determine whether identification of two different bacteria in     urine culture of patients with indwelling catheter has a clinical impact - change in     antibiotic, duration of antibiotic, days to clinical resolution and length of stay in     hospital.      The microbiology laboratory will randomized urine cultures with two bacteria from indwelling     catheter to either reporting identity and susceptibility of the bacteria or reporting mixed     growth.   "
244859|NCT01060969|"     To evaluate the additive value of tadalafil given together with Diamox (acetazolamide) in     preventing acute mountain sickness in travelers to high altitude areas.   "
244860|NCT01060982|"     This study is a multicentre, open, uncontrolled trial for the observation of histological     changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).      This study will be conducted in France in 10 patients with primary hyperparathyroidism     scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center     of the adenoma before the surgery.   "
244861|NCT01060995|"     SUMMARY:      The purpose of this study is to learn how to better educate patients about oral health     procedures and treatments through an improved informed consent process. We will gather     information from patients and health care providers, and design and test a computerized     consent system called SmartConsent.      HYPOTHESIS:        1. Subjects who use SmartConsent will have increased knowledge (cognitive achievement)          about oral health disease and treatment than patients who view the standard consent        2. Subjects who use SmartConsent will have less decisional conflict in their decision          regarding an oral health procedure than those who view the standard consent form        3. Subjects who use SmartConsent will have greater visit satisfactions scores than those          who view the standard consent form   "
244862|NCT01061008|"     The purpose of this study is to investigate whether post operative progressive forearm     exercise is effective in improving arteriovenous fistula maturation in chronic kidney disease     patients.   "
244892|NCT01061398|"     In patients with chest pain or shortness of breath who are referred for stress imaging tests     (either stress echocardiography or stress nuclear testing), the investigators seek to compare     impact of using cardiac CT scans of the heart arteries to the stress test that their doctors     ordered.   "
244863|NCT01061021|"     HIV prevention interventions are needed to assist people living with HIV/AIDS to adhere to     their medications and not transmit the virus to others. This study is testing a behavioral     intervention designed to address both medication adherence and risk reduction in people     living with HIV/AIDS. It is hypothesized that the experimental behavioral intervention will     show improved medication adherence and safer sexual behaviors compared to a comparison group.   "
244864|NCT01061034|"     Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion     while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid     secretion.      We assumed that omeprazole inhibits aspirin absorption, thus reducing its action on     platelets.      healthy volunteers, with no known peptic disease or bleeding disorders will be enrolled.      All volunteers will receive 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin     and Omeprazole 20mg twice daily for 3 days and then 20mg once daily.      Blood levels of Aspirin will be determined by High performance liquid chromatography (HPLC),     0, 1, 2, 4, 6, 10, 24 hours after the administration of Aspirin alone on day 7 and Aspirin     plus Omeprazole on day 21.      Platelet function tests will be determined by platelet-rich plasma aggregometry in response     to Arachidonic acid (500mg/ml), Ristocetin (1.5mg/ml) and Adenosine 5'-diphosphate (20mM) on     day 0 as baseline and on day 7 and 21 of the study.   "
244865|NCT01061047|"     Ertapenem is an antibiotic that is highly bound to plasma protein (> 95%). The effects of     this high protein binding on tissue distribution of antibiotics have been few evaluated yet.      In this study, two groups of subjects will be compared: 6 healthy volunteers and 6 critically     ill patients (patients with infection due to an Ertapenem susceptible bacteria). Indeed,     these 2 populations show changes in binding capacity of drugs to plasma proteins due to a     decrease of protidaemia and of the affinity of drugs to transport proteins.      It seems therefore important to clarify the consequences of a modification in protein binding     on distribution of antibiotics. That's why we have decided to characterize tissue     distribution of ertapenem in healthy volunteers and critically ill patients by assessing:     free and total concentrations in plasma and free concentrations in muscle by microdialysis.   "
244866|NCT01061060|"     This study attempts to examine the effect of oral prostaglandin I2 (Beraprost Na),     administered for eight weeks, on the endothelial cell functional disorder among asymptomatic     high risk diabetes mellitus patients.   "
244867|NCT01061073|"     JJ ureteral stent represents an advance in the management of the upper urinary tract     obstruction as it allows the patient to resume his activities although he is stented between     the kidney and the bladder.      However, in many cases, this JJ stent is not well tolerated and can even be unbearable.      This trial evaluates the benefit of tamsulosin (an alpha-blocker) in improving the tolerance     of JJ stents compared to low-doses of phloroglucinol.   "
244868|NCT01061086|"     This is a multicenter, 2-phase observational study of acute coronary syndromes (ACS) in     Greece, designed to provide real world data on the risk factors of patients presenting to a     hospital emergency department with an index event, as well as to depict the current     management practices and outcomes of these clinical conditions in Greece.   "
244870|NCT01061112|"     This research study will help determine how a person's genetic makeup affects their responses     to drugs, the ability of the body to break down drugs, and their potential to experience an     interaction between drugs. We are investigating the drug interactions between an antifungal     drug called fluconazole and the commonly used drugs tolbutamide, flurbiprofen, and     ketoprofen. Tolbutamide is used for management of Type 2 diabetes. Both flurbiprofen and     ketoprofen are non-steroidal anti-inflammatory drugs (NSAIDs) often used for arthritis or     pain. We are interested in studying whether individuals with certain genetic profiles have     different drug interactions than normal. This research is being done to see if certain     genetic profiles require us to adjust medication doses differently than is needed for the     general population. Genetic profiles of subjects are determined from their previous     participation in the Pharmacogenetics Registry (Investigator Richard Brundage, University of     Minnesota).      The study hypothesis is: Fraction metabolized by CYP2C9 enzyme determines the extent of drug     interactions in CYP2C9*1/*1 individuals but this factor (fraction metabolized) becomes less     influential and drug interactions are attenuated in a gene-dose dependent manner in     individuals with one or more defective alleles.   "
244871|NCT01061125|"     This is a randomized pilot study, of post pulmonary vein isolation (PVI) patients to     determine the clinical utility of the Implantable Loop Recorder. These type of patients     either are monitored with weekly transtelephonic monitoring (TTM) or implantable loop     recorder (ILR). The Medtronic Reveal XT loop recorder will be implanted at the time of the     PVI or at the 3-4 month PVI follow-up visit and patient care will be managed based on     randomization to a blinded or unblinded group. Outcome measures will be compared to aid in     decision making regarding anticoagulation and overall post ablation clinical management.   "
244872|NCT01061138|"     The primary objective of this study is to acquire digital mammography images produced by the     Xpress Digital Mammography System in order to develop Computer Aided Detection software and     systems.   "
244873|NCT01061151|"     The purpose of this study is to examine effective methods of preventing the transmission of     HIV from mother to child during pregnancy, labor and delivery, and breastfeeding. This is one     part of the three-part PROMISE study and will be conducted at locations in Africa and other     parts of the world where women typically receive a short course of highly active     antiretroviral therapy (HAART) during pregnancy and where breastfeeding is common.   "
244874|NCT01061164|"     This study will examine the long-term effects of HIV infection, highly active antiretroviral     therapy (HAART), and experimental treatments on children who participated in PACTG 219C or     select IMPAACT studies.   "
244875|NCT01061177|"     This study will assess the efficacy and safety of nilotinib in adult patients with newly     diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in     chronic phase. The aim of the study is to confirm the rates of complete molecular remission     (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population     using the EUTOS standardized laboratories.   "
244876|NCT01061190|"     The objective of this trial is to assess the safety and efficacy of neuro- and     cardioprotective effects of propranolol in acute ischemic stroke. Furthermore, exploratory     analyses of cardiologic-electrophysiologic and immunologic parameters will be performed.   "
244878|NCT01061216|"     The primary objective of this study will be to assess the PK/PD responsiveness of basal ID     administered insulin compared to SC, and to determine the safety and local tolerability of     extended (two six-hour periods) microneedle insulin delivery (MID) infusion. The primary     endpoint will be the PK response to changes in rapid-acting insulin basal infusion rate.      Faster PK transitions coupled with faster PD responsiveness could provide clinical benefit,     compared to current subcutaneous insulin infusion. In addition, for nocturnal basal pumping,     more rapid insulin offset could decrease the occurrence rate and severity of hypoglycemic     episodes.   "
244879|NCT01061229|"     The main aim of the study is to determine whether a homeopathic drug in the potency C12     provokes more characteristic homeopathic proving symptoms after three weeks compared to a     placebo in healthy volunteers.      Secondary aims are to develop and to test a qualitative analysis methodology on which to base     a definition for drug-specific (characteristic) symptoms and to compile a profile of     characteristic homeopathic proving symptoms of the drug being trialled for therapeutic     purposes.      This study protocol adapts the traditional homeopathic drug proving methodology to a modern     clinical trial design.   "
244880|NCT01061242|"     The purpose of this study is to understand patients' neurocognitive performance shortly after     discharge from the Medical Intensive Care Unit (MICU) and the potential effect of sleep     quality in the MICU on those neurocognitive outcomes. The investigators hypothesize that     post-ICU neurocognitive function and patient overall ICU sleep experience will improve     through a pre-existing MICU sleep improvement initiative.   "
244881|NCT01061255|"     Solving a problem in ambulatory setting may contain peripheral stress due to socio-evaluative     stressors (patient's expectations about explanations) and task contingent stress due to time     pressure, the necessity to take into account patient's mood, to deal with uncertainty of     their own data collection and with complex clinical situations. In France, excepted for     family medicine, undergraduate medical students and residents are currently not trained to     perform consultations and are never exposed to ambulatory patients during training. The     investigators postulate that this lack of practice may generate a significant state of stress     during the first consultations and consequently modify or even impair clinical reasoning.      The primary objective of this study is to compare subjective and physiological levels of     acute stress in ambulatory versus hospitalization setting in medical students confronted to a     real patient with a diagnostic problem.      Measures: The French version of the Anxiety Spielberger test is administered just before and     after each problem solving session.      Cortisol salivary samples are taken before and after each problem solving session. Salivary     cortisol levels have been shown to be correlated to stressful situations and some personality     traits but with some difference according to gender.      Cognitive appraisal (threat/challenge) is assessed before and after the tasks by the ratio of     primary appraisal to secondary appraisal according to Tomaka et al.   "
244884|NCT01061294|"     The purpose of this study is to assess the efficacy, predictability and safety of the     Advanced CustomVue™ iLASIK procedure (WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser     System and IntraLase™ FS System). Patient data will be collected electronically and analyzed     to determine improvements in postoperative visual acuity, visual quality and residual error.   "
244885|NCT01061307|"     Iron, zinc and vitamin A deficiencies are particularly common among children and young women     in the developing countries of South and Southeast Asia resulting in important adverse health     effects. Simultaneous fortification of rice with iron, zinc and vitamin A could be a novel     and sustainable approach to control these deficiencies.      Recently conducted extrusion trials have demonstrated that extruded rice grains containing     iron, zinc and vitamin A show acceptable stability during production and storage and good     sensory properties. The grains were produced using a twin-screw extruder equipped with a     special cutter and a rice shaping die. The Fe, Zn and vitamin A content of the extruded     product is 10 mg, 9 mg and 1050 μg per g of rice, respectively.      In this study the investigators plan to test the efficacy of the extruded triple fortified     rice in Satun, Thailand, an area where rice is the staple food. Preliminary data from this     area show that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc     deficiency and suboptimal vitamin A status in 1/3 of school aged children. The efficacy of     the fortified rice will be evaluated in a 9 months, controlled, double-blind intervention     trial in 7-12 y-old children. Children will be selected from primary schools in Satun     Province based on low serum zinc values as the primary goal is to investigate Zn efficacy. As     secondary outcome the effect on iron and vitamin A status will be investigated. The children     will be randomized into two groups: a control group will receive a daily non-fortified rice     lunch meal at school, while the second group will receive a daily rice meal containing the     triple fortified rice. The rice meals will be given 5 days a week. At baseline, weight and     height will be measured and determination of hemoglobin, serum ferritin, zinc protoporphyrin,     serum zinc, serum retinol and C-reactive protein will be done. At mid-point and at 9 months,     the baseline measurements will be repeated to judge the efficacy of the triple fortified     rice.   "
244886|NCT01061320|"     The purpose of this study is to demonstrate the efficacy of alpha tocopherol for prevention     contrast-induced nephropathy in CKD patients undergoing elective coronary procedures.   "
244887|NCT01061333|"     This study will assess the Early Airway Response (EAR) associated change in forced expiratory     volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of     nedocromil, montelukast, and mometasone.   "
244888|NCT01061346|"     This study is designed to test the effects on liver fat of varying fat intake in the presence     of fructose or glucose. We hypothesize that higher dietary fat when eaten with fructose as     compared to glucose will increase the amount of hepatic lipid as measured by magnetic     resonance spectroscopy.   "
244889|NCT01061359|"     Evaluation of efficacy of treatment with epirubicin (5 years follow-up). Evaluation of     frequency of dose reduction. Evaluation of frequency of neoadjuvant treatment with E(120mg) /     C(600mg). Evaluation of unexpected and serious adverse events.      (E=Epirubicin; C =Cyclophosphamide)   "
244890|NCT01061372|"     The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate     to severe Restless Legs Syndrome in comparison to placebo.   "
244891|NCT01061385|"     The study evaluated the safety and efficacy of the ReShape Intragastric Balloon as an adjunct     to diet and exercise in obese patients compared with diet and exercise alone. The study     device is designed to occupy space within the stomach and induce satiety. After approval from     the institutional review board, patients provided written consent and were randomized to the     treatment group (with endoscopic placement of study device) or the control group (no     placement of study device) on an unblinded basis. Both groups received similar diet and     exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events,     and quality of life data were evaluated throughout the 48 week study duration.   "
245488|NCT01073150|"     The purpose of this study is to determine:        -  The prevalence of Demodex sp. in chronic blepharitis.        -  The efficacy of the treatment of topical Tree Tea Oil in chronic blepharitis for Demodex          sp.   "
244893|NCT01061411|"     This phase I trial studies the side effects and best dose of dalteparin when given together     with sunitinib malate in treating patients with kidney cancer that has spread to other parts     of the body or cannot be removed by surgery. Anticoagulants, such as dalteparin, help prevent     blood clots and have been shown to increase survival in patients with cancer. Anticoagulants     may also prevent the formation of new blood vessels. Sunitinib malate may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth and by inhibiting new     blood vessels and blocking blood flow to the tumor. Giving dalteparin together with sunitinib     malate may starve tumors and kill more tumor cells.   "
244894|NCT01061424|"     This study compares an asthma self-management intervention, delivered to the family and     tailored to their needs and cultural beliefs, to standard asthma education in high-risk     Puerto Rican children in elementary school. The primary outcomes are asthma medication     adherence and trigger reduction.   "
244895|NCT01061437|"     The purpose of this study is to compare the effectiveness of three different antibiotic     regimens against Helicobacter pylori (H. pylori).   "
244896|NCT01061450|"     Diastolic dysfunction (DD) is an increasingly frequent condition in hypertensive individuals     whose treatment remains unclear. Its presence is related to higher morbidity and mortality     independent of blood pressure levels. The aim of this study is to investigate the additive     effect of simvastatin on enalapril on DD in hypertensive patients with average cholesterol     levels.      For this aim, hypertensive patients with DD and LDL-cholesterol <160 mg/dL will undergo a     run-in phase to achieve a systolic blood pressure (SBP) <135 mmHg and diastolic blood     pressure (DBP) <85 mmHg with enalapril. Hydrochlorothiazide could be added when need to     achieve SBP or DBP control. Four weeks after reaching the optimum anti-hypertensive regimen     patients will be randomized to receive 80 mg simvastatin or placebo for a period of 20 weeks.     Echocardiograms will be performed before and after treatment with measurement of left atrial     volume, conventional and tissue Doppler velocities in early diastole and late diastole. The     evaluation of these will allow to identify changes of DD severity after treatment.   "
244897|NCT01061463|"     The purpose of this study is to test the existence of an increased risk of cataracts among     interventional cardiologists as compared to cardiologists not exposed to X-rays.   "
244898|NCT01061476|"     Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for     the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is     suboptimal in many patients, making alternative therapies desirable. Recently, a novel device     (Provent™) has been developed for the treatment of snoring and OSA. The purpose of the     current study is to examine how well the Provent™ device treats OSA with particular attention     to the how the it may treat sleep apnea and who may most likely benefit from the use of this     treatment.   "
244899|NCT01061489|"     Age-related cognitive decline is unavoidable. However, recent results of     neuroplasticity-based research show that neuroplasticity-based training and physical activity     might have the potential to decelerate or even reverse effects of aging and age-related     cognitive impairments. Little is known whether these results also apply to pathological     processes of aging such as mild cognitive impairment (MCI) and dementia.      This multi-center study aims at investigating efficiency and feasibility of a     neuroplasticity-based auditory discrimination training and a physical fitness training for     patients suffering from mild cognitive impairment or mild Alzheimer's disease (Mini Mental     State Examination, MMSE > 19). Evaluation will include neuropsychological testing,     electroencephalography (EEG) and magnetic resonance imaging (MRI) measurements as well as     blood and liquor analyses.   "
244900|NCT01061502|"     The purpose of this study is to determine whether the use of a bioelectric wound dressing is     effective in the healing of skin graft donor site wounds.   "
244901|NCT01061515|"     This study is to test escalating doses of intraperitoneal (IP) oxaliplatin in conjunction     with systemic bevacizumab and capecitabine in patients with Peritoneal Carcinomatosis (PC)     from either appendiceal or colorectal adenocarcinoma that have been adequately cytoreduced     and have undergone a peritoneal scan demonstrating patency of at least one of the     intraperitoneal ports that were placed at the time of debulking.   "
244902|NCT01061528|"     The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and     acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation     treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments,     participants will receive one 60-minute individual session, seven 2-hour group sessions and     two individual brief telephone contacts over an eight-week period. Both treatments include 8     weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and     will continue after the treatment sessions have ended. Participants will provide follow-up     data with regard to their smoking status through a one-year follow-up period.   "
244903|NCT01061541|"     In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a     DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to     be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5).     The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine     when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive     Tritanrix™-HepB/Hiberix™.      Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects     50% were randomised to participate in the PRP challenge study (208108/092) (open), and all     subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).   "
244904|NCT01061554|"     The purpose of this study is to compare the short term absorption of EPA and DHA from     triglycerides (TG) released from normal soft gel capsules and from the new patent pending     vehicle providing a gastric stable emulsion.   "
244905|NCT01061567|"     The general aim of this non-interventional study is to assess the safety and efficacy of     pramipexole extended release in patients with Parkinson's disease in routine clinical     practice.   "
244906|NCT01061580|"     Injection of concentrated bone marrow cells into the myocardium during CABG procedure.   "
244907|NCT01061593|"     Dzherelo (Immunoxel) is an oral immunomodulating botanical agent available over-the-counter     in Ukraine. After many years of laboratory and clinical testing the formulation was approved     in 1997 by the Ministry of Health of Ukraine as a dietary herbal supplement, which enhances     immunity against viral and infectious diseases. The goal of this study is to conduct     confirmatory clinical trial in Ukraine and Mongolia for TB indications.   "
244908|NCT01061606|"     This phase II trial is studying how well temsirolimus works in treating patients with     recurrent or persistent cancer of the uterus. Temsirolimus may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth.   "
244909|NCT01061619|"     The purpose of this study is to describe the prediagnostic symptoms and the events along the     pathway to diagnosis of women with ovarian cancer, referred for first-line chemotherapy.   "
244910|NCT01061632|"     The aim of the study is to evaluate and compare the effects of high-intensity (deadlift)     versus low-intensity motor control exercises on selfrated pain, function and symptoms on     patients with peripherally mediated pain   "
244911|NCT01061645|"     Immunotoxins (ITs), monoclonal antibodies conjugated to plant or bacterial toxins, have been     extensively investigated for their possible use as anti-tumor agents although not in     carcinoma patients with minimal residual disease. Various ITs have been tested in early     clinical trials and recent studies demonstrate anti-tumor activity of IT treatment in     patients with glioblastoma and different solid tumors. Systemic treatment with immunotoxins     directed against carefully selected epithelial cell surface molecules may have a potential     for eradicating also dormant metastatic tumor cells, as their action is independent of cell     proliferation. The effector moieties of the IT used here, the Pseudomonas exotoxin A (PE),     inhibits protein synthesis in eukaryotic cells by catalytic inactivation (ribosylation) of     elongation factor 2 in the ribosome complex.   "
244912|NCT01061658|"     A double blind placebo controlled Phase I/II study to evaluate the safety and immunogenicity     of the Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine     [BRV-TV]in Indian infants. The study would be carried out in 90 healthy infants. Three doses     of the rotavirus vaccine or placebo would be administered orally to each infant at 6-8, 10-12     and 14-16 weeks of age. The rotavirus vaccine would be administered at one of the two planned     virus concentrations (10e5.5 or 10e6.25 FFU of each constituent serotype per 0.5 ml). Each     administration of the vaccine/placebo would be preceded by oral administration of 2.0 mL of     antacid.   "
244913|NCT01061671|"     To determine the effect of daily administration of 40 mgms simvastatin taken for at least 12     months (range 12-36 months) on the frequency of exacerbations of chronic obstructive lung     disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do     not have other indications for statin treatment.   "
245053|NCT01068483|"     This is a first-in-man, phase I clinical research study with BKM120, a potent and highly     specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists     of a dose escalation part followed by a MTD expansion part.      Once the MTD has been defined, the MTD expansion part will be opened for enrollment.   "
244914|NCT01061684|"     The NAFLD Database 2 will recruit at least 650 new pediatric participants with liver biopsies     and contemporaneous biosamples, and will also invite pediatric participants from the prior     NAFLD Database and TONIC trial (50 with a recent biopsy and 150 without a contemporaneous     biopsy) to enroll in the NAFLD Pediatric Database 2 study. Combining the new and continuing     participants leads to a recruitment goal for the pediatric Database 2 of 850 pediatric     participants during the enrollment period.   "
244915|NCT01061697|"     This study is designed to investigate the effectiveness of pregabalin (Lyrica) on nerve pain     caused by degenerative neck problems. Pregabalin is a new drug registered for use in nerve     pain worldwide   "
244916|NCT01061710|"     The purpose of this study is to collect the efficacy and safety information in subjects who     have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for     their appropriate use in daily practice and are participants for varenicline Drug Use     Investigation protocol A3051109 ((NCT# NCT00772941).   "
244917|NCT01061723|"     Primary objective:      - to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS)     using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20)      Secondary objectives:        -  to demonstrate that Sarilumab was effective on:             -  assessment of higher level of response [ASAS 40% response criteria (ASAS40)]             -  partial remission             -  disease activity             -  range of motion             -  Magnetic Resonance Imaging (MRI) of the spine        -  to assess the safety and tolerability of Sarilumab in participants with AS as well as          the pharmacokinetic profile of Sarilumab in participants with AS   "
244918|NCT01061736|"     Primary Objectives:      Part A (dose ranging study):      To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of     signs and symptoms of rheumatoid arthritis at 12 weeks.      Part B (pivotal study):      To demonstrate that sarilumab added to MTX was effective in:        -  reduction of signs and symptoms of rheumatoid arthritis at 24 weeks        -  inhibition of progression of structural damage at 52 weeks        -  improvement in physical function at 16 weeks      Secondary Objectives:      Part B:      To demonstrate that sarilumab added to MTX was effective in induction of a major clinical     response at 52 weeks      To assess the safety of sarilumab added to MTX      To document the pharmacokinetic profile of sarilumab added to MTX in participants with active     rheumatoid arthritis who were inadequate responders to MTX therapy.   "
244919|NCT01061749|"     This phase I clinical trial studies the safety and best dose of selumetinib and cixutumumab     in treating patients with advanced solid malignancies. Selumetinib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,     such as cixutumumab, can block tumor growth in different ways. Some block the ability of     tumor to grow and spread. Others find tumor cells and help kill them or carry     [cancer/tumor]-killing substances to them.   "
244920|NCT01061762|"     Consistent adherence to antiretroviral therapy is necessary for treatment success. People     with poor health literacy skills experience considerable difficulty adhering to their     medications. Effective strategies for improving adherence in patients with poor health     literacy must be tailored to achieve optimal adherence and therefore viral suppression. This     proposal requests support to conduct a randomized clinical trial of a theory-based HIV     treatment adherence intervention tailored for people with low-literacy skills.   "
244921|NCT01061775|"     The primary aim of this study is to evaluate the effect of Exenatide on weight status (change     in body mass index) of children treated for craniopharyngioma that have developed     hypothalamic obesity at Children's Hospitals and Clinics of Minnesota. We hypothesize that     Exenatide given to hypothalamic obese children for 6 months will reduce their body mass index     significantly from baseline.   "
244922|NCT01061788|"     This open-label, non-randomized, dose escalation phase I biomarker trial of the triplet     regimen of AMG 479, everolimus, and panitumumab for subjects with refractory advanced solid     tumors is designed to assess the safety and tolerability of this combination as well as     preliminary efficacy.   "
244923|NCT01061801|"     This study seeks to test a brief psychological intervention for spousal caregivers of cancer     patients (specifically, hematopoietic stem cell transplant patients), persons known to     experience emotional distress.   "
244924|NCT01061814|"     Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL).     Elevated LDL is a major risk factor for coronary heart disease (CHD). Mipomersen is an     antisense drug that reduces a protein in the liver cells called apolipoprotein B-100     (apoB-100). ApoB-100 plays a role in producing low density lipoprotein cholesterol (LDL-C)     (the 'bad' cholesterol) and moving it from the liver to one's bloodstream. High LDL-C is an     independent risk factor for the development of coronary heart disease (CHD) or other diseases     of blood vessels. It has been shown that lowering LDL-C reduces the risk of heart attacks and     other major adverse cardiovascular events.      Mipomersen is an investigational product being studied to determine if it is safe and     effective in lowering LDL-C in specific populations of patients with hypercholesterolemia.      This phase 1 study is being conducted to evaluate 3 different dosing regimens (daily, 3 times     per week, or weekly) in healthy volunteers for a total of 3 weeks of dosing. Study procedures     will include blood testing and physical examinations to assess the safety and tolerability of     the different regimens. Tests will also be done to determine how much of the drug is present     in the circulation (blood flow in the body). Specific pharmacokinetic (PK) tests on the blood     samples will determine what the body does to the investigational product after it is     injected, including how it is absorbed, distributed, the rate at which drug action begins and     the duration of the effect.      Eligible subjects will receive study injections of either mipomersen or placebo over a 3 week     period followed by a 12 week safety follow-up period.   "
244939|NCT01062022|"     The purpose of this study is to implement a unique evidence-based intervention program to     help military families deal with the critical issue of combat injury and its impact on     current and future family health and functioning. The study is a randomized study. The study     will compare the effects of the newly designed FOCUS-CI (Families OverComing Under Stress -     Combat Injury) with the existing standard of care (SoC) at three military medical     rehabilitation sites (Walter Reed Amry Medical Center, Brooke Army Medical Center and Madigan     Army Medical Center) on key aspects of family health and functioning.   "
244925|NCT01061827|"     A major public health issues of today's aging population is the development of knowledge and     expertise in geriatric medicine and psychiatry of the elderly. The depressive disorders and     dementia, are among the psychiatric conditions most common in older age. They are the subject     of much clinical research, in which brain imaging techniques used to establish correlations     anatomo-clinical and radiological-clinical. The prerequisite for the realization of such work     locally, is the validation in their French version of clinical assessment tools most commonly     used internationally, ensuring reliability, acceptability and comparability of results. Among     these tools, Geriatric Mental Schedule (GMS) Package, is the reference tool for research in     psychiatry of the elderly. It is a standardized and structured questionnaire that allows to     establish with reliability and reproducibility on the basis of answers to questions, major     psychiatric diagnoses in the elderly. It has been validated in several languages (German,     Spanish, Italian, Dutch, but also Chinese, Korean ...), but is still not available in French.      Hypothesis: Validate the the French version of Geriatric Mental Schedule (GMS) Package, to     establish diagnoses of dementia and depressive disorders.   "
244926|NCT01061840|"     Autologous Vigil™ vaccine expresses rhGMCSF and bi-shRNAfurin from the Vigil™ plasmid. The     GMCSF protein is a potent stimulator of the immune system, recruiting immune effectors to the     site of intradermal injection and promoting antigen presentation. The furin bifunctional     shRNA blocks furin protein production at the post transcriptional and translational levels.     This decrease in furin in turn decreases the conversion of the proforms TGFβ1 and TGFβ2     proteins. Also, reduced furin protein levels have a negative feedback inhibition on TGFβ1 and     TGFβ2 gene expression, decreasing the levels of their mRNAs. The resulting decrease in TGFβ1     and TGFβ2 proteins reduces the local immunosuppression they cause and promotes tumor surface     antigen and MHC protein display.   "
244927|NCT01061853|"     The purpose of this study is to determine wether topical rapamycin is more efficient than     topical steroids in the treatment of chronic erosive lichen planus.   "
244928|NCT01061866|"     The purpose of this study is to determine whether thalidomide is effective in the refractory     epilepsy treatment.   "
244929|NCT01061879|"     By doing this study, researchers hope to develop a special technique and laboratory     conditions to help support umbilical stem cell growth and multiplication.      In this project, researchers propose a three dimensional (3D) microenvironment that mimics     the bone marrow stem cell microenvironment, with its supporting cells of osteoblasts and     stromal cells. In theory, this will result in better expansion of cord blood stem cells ex     vivo.   "
244930|NCT01061905|"     This is the second in a series of pilot interventions we are conducting to assess how     principles from behavioral economics can be applied to improve consumers' food choices. In     collaboration with Aramark, the food service vendor, we intend to examine if calorie labeling     in different formats impacts consumers choice of bottled beverages in hospital cafeterias.     Specifically, we will be testing whether signage that conveys to consumers the number of     calories in each bottled beverage will increase the number of zero-calorie beverages sold     relative to non-zero-calorie beverages. Likewise, we will test whether signage that conveys     calories in exercise equivalents increases the sale of zero-calorie beverages. Lastly, we     will test if signage conveying standard calorie information in conjunction with exercise     equivalents increases the sale of zero-calorie beverages. We will measure the differential     effect of each of these three formats for calorie information.   "
244931|NCT01061918|"     The purpose of this study is to compare the visual outcomes with bilateral implantation of     Tecnis MF and ReSTOR intraocular lenses (IOLs) 6 months post cataract surgery.   "
244932|NCT01061931|"     The purpose of this prospective randomized single-center trial is to compare efficiency and     safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial     fibrillation using the Arctic Front® versus the HD Mesh Ablator® catheter.   "
244933|NCT01061944|"     In this research study, we are looking at performing a repeat biopsy of patients' tumors,     even though they have already been diagnosed with cancer. The tumor tissue obtained from the     biopsy will be studied to see what it looks like at the molecular (genetic) level. By     conducting this study, we hope to learn more about how cancers work, why cancers respond to     certain treatments, and how they become resistant to certain treatments. We also hope to     demonstrate that biopsies like this can be performed safely in large numbers of patients. The     research done on the tumor samples may help us identify which patients in the future are most     likely to respond to new cancer therapies.   "
244934|NCT01061957|"     Raltegravir is the first integrase inhibitor approved for treatment of HIV infected patients     harboring multiresistant viruses. The drug has been proved effective in both trials and     clinical settings, but the long-term efficacy is not described and the effect compared to     treatment in Highly active antiretroviral therapy (HAART) naive patients remains to be     established.   "
244935|NCT01061970|"     The objective of the study is to assess and compare the preliminary efficacy, safety and     tolerability of fispemifene 300 mg and placebo given once daily for 4 weeks in the treatment     of hypogonadal men with chronic obstructive pulmonary disease (COPD) that are on oral     glucocorticoid therapy.   "
244936|NCT01061983|"     This study will evaluate the safety and effectiveness of deep brain stimulation in treating     people with severe and otherwise treatment-resistant obsessive-compulsive disorder. We also     expect to determine how DBS affects brain activity in brain circuits strongly implicated in     OCD, and how such effects may relate to symptom change. This treatment study therefore also     permits a unique and crucial test of current neuroanatomical models of both OCD pathogenesis     and mechanisms underlying the response to treatment.   "
244937|NCT01061996|"     Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in     subjects with ulcerative colitis who completed previous basiliximab studies.      Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this     multiple-dose maintenance regimen in this population   "
244938|NCT01062009|"     The purpose of the study is 1) to determine whether administration of intravenous zinc to     critically ill children is safe, and 2) to determine an appropriate dose of zinc     supplementation.   "
245073|NCT01068743|"     To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination     (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage     Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed     condition.   "
244940|NCT01062035|"     The aim of this study is to develop a blood test to determine which patients are at risk for     pre-cancerous colon polyps (ACPs: Advanced Colon Polyps). The telomere length of peripheral     blood lymphocytes (PBLs) can be measured from a blood sample. Mechanistic pathways and the     investigator's preliminary data support PBL telomere length as a biomarker for ACPs. The     long-term goal of this project is to decrease deaths from colon cancer by using a blood test     to target colonoscopy for those patients who are at high risk for pre-cancerous polyps.   "
244941|NCT01062048|"     The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in     Korean participants, and 2) To identify factors that might have an influence on the safety     and efficacy profile of Januvia in Korean participants.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
244942|NCT01062061|"     This survey is conducted for preparing application materials for re-examination under the     Korean Pharmaceutical Affairs Laws and its Enforcement Regulation; its aim is to reconfirm     the clinical usefulness of VARIVAX through collecting the safety information according to the     Re-examination Regulation for New Drugs.   "
244943|NCT01062074|"     This survey is conducted for preparing application materials for re-examination under the     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the     clinical usefulness of Gardasil through collecting the safety information according to the     Re-examination Regulation for New Drugs.   "
244944|NCT01062087|"     The purpose of this study is to attempt to determine retrospectively whether there was a     statistically significant difference in patient need for postoperative narcotics between two     different groups of women who received a laparoscopic tubal ligation. One group received a     local anesthetic injection or gel at the surgical sites, in addition to general anesthesia.     The other group did not receive any local anesthetic but did receive general anesthesia. The     investigators hypothesize that the group that received the local anesthetic injection or gel     had lower average postoperative narcotic requirements and shorter postoperative dismissal to     home times than the group that did not receive the auxiliary local anesthetic.   "
244945|NCT01062100|"     To evaluate the feasibility, acceptability and safety of using a molecular breast imaging     (MBI) Gamma Camera in women at high risk of developing breast cancer   "
244946|NCT01062113|"     To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in     patients with post lateral mandibular impacted third molar tooth extraction pain.   "
244947|NCT01062126|"     Pacemaker technology is constantly evolving. In the past 10 years, numerous advancements have     been made in pacemaker therapy, diagnostics and connectivity. These advancements include     automated capture, automated sensing, patient alert functions, algorithms minimizing     ventricular pacing, automatic mode switching in response to atrial tachyarrhythmia, rate     responsive pacing, advanced diagnostic features, remote monitoring and radiofrequency (RF)     technology. However, little information is available on how these new features are being     utilized by physicians in the real world and how these features impact patient outcomes.      This observational study will gather data on the patients' presenting clinical status,     indication for device implantation, utilization of advanced device features, device therapy     choices, clinical management and outcomes in a general pacemaker population.      The primary aim of the study is to evaluate the usage of advanced features and diagnostics in     patients with St. Jude Medical pacemakers. The secondary aim of the study is to learn more     about the progressive clinical outcomes in the general pacemaker patient population. The     tertiary aim of the study is to evaluate the correlation between the usage of advanced     features in pacemaker patients and the patient's clinical outcomes.   "
244948|NCT01062139|"     Title of Study:      A randomized, parallel, double-blind, multi-center, comparative study to evaluate the     efficacy and safety of Cosalin monotherapy versus Cosalin and Xarlin combination therapy in     patients with allergic rhinitis      Objective of study:      To exploratively evaluate superiority of combination therapy - twice-daily Cosalin Tab     (Petasites hybridus CO2 extract) with once-daily Xarlin Tab (Levocetirizine HCl) - compared     to monotherapy of Cosalin with allergic rhinitis subjects.   "
244949|NCT01062152|"     This is an open label, multicenter Phase 1 dose escalation study evaluating five doses of     ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate     1 risk MDS. The HI-E, HI-N, HI-P rates [by International Working Group (IWG) 2006 criteria]     and safety of each treatment group will be evaluated to select the optimal dose of ezatiostat     in combination with lenalidomide for future studies.   "
244950|NCT01062165|"     This study will find how weight affects the dosing of a drug called caspofungin. Currently,     the amount of caspofungin a patient receives is the same regardless of the patient's weight.   "
244951|NCT01062178|"     Patients with an incidentally discovered small renal masses (SRM) < 4 cm in diameter are     included. All patients will undergo biopsy for tissue diagnosis. Most patients will be     followed by imaging. Study intervention includes low MI US to be performed following both     bolus and infusion injection of Definity contrast. Presence and absence of vascularity,     pattern of vascularity, and TIC values will be correlated with the final pathology to find     features differentiating benign from malignant masses.   "
244952|NCT01062191|"     The objective of this study is to evaluate the difference in joint range of motion of a new     flexible hydrogel nanoparticle wound dressing compared to typical sodium     carboxymethylcellulose dressing Aquacel AG for treatment of partial thickness burns.   "
244953|NCT01062204|"     The primary objective of the study is to evaluate the time to wound healing in skin graft     donor sites with a new treatment (Altrazeal dressing) compared to standard of care treatment     (Aquacel Ag- Carboxymethylcellulose dressing) in partial thickness skin graft donor sites.   "
245054|NCT01068496|"     This study looks at global gene expression in pterygium and found the derangement of matrix     genes in particular to be a feature of pterygium. In the investigators opinion, it would be     more beneficial to elicit changes in gene expression before the recurrence of pterygium and     by developing a panel of biomarkers that are associated with pterygium recurrence; one would     be able to predict the post surgical prognosis of patients after resection.Biomarker levels     will be compared to discover a biomarker panel for prediction of recurrence.   "
244954|NCT01062230|"     The primary aim of this trial is to determine the effect of a short course (i.e., 3 cycles)     of low-dose Bortezomib (Velcade) on bone remodeling and on disease progression. The dose of     bortezomib used in this trial of 0.7 mg/m2 is the lowest dose which has shown efficacy in the     3 largest monotherapy trials with bortezomib. 17% of patients in the APEX, 9% patients in     CREST and 24% in SUMMIT trials were treated with 0.7 mg/m2 dosages. Bortezomib will be given     on days 1, 8, 15, 22 over 42 days to reduce the incidence of possible drug related side     effects.      OBJECTIVES:      Primary Objective      The primary objective of this study is to:        -  To evaluate the effect of Velcade at 0.7 mg/m2 dose on inducing osteoblast activation as          measured by ALP and other bone markers in patients with relapsed/refractory myeloma.      Secondary Objectives      The secondary objectives of this study are to:        -  To evaluate the association between osteoblastic activation and myeloma response to          Velcade.        -  To identify predictive factors for Velcade-associated osteoblastic activation.   "
244955|NCT01062243|"     The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS) is a comprehensive     intervention to meet the needs of family members and significant others of patients who are     undergoing acute, inpatient brain injury rehabilitation.   "
244956|NCT01062256|"     The objectives of this study are: a) to assess the feasibility and sensitivity of manually     count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and     guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and     severity of acute cough due to upper respiratory tract infection and c) to evaluate the     correlation between cough bout frequency and subjective assessments of cough severity. The     hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release     guaifenesin will significantly reduce the frequency and severity of cough compared to placebo     over a 4-hour evaluation period.   "
244957|NCT01062269|"     The purpose of the research study is (1) to rate the taste, texture, appearance, and     mixability of 2 different doses of orange flavored cholestyramine compared to orange flavored     Tang, (2) rank the importance of the taste, texture, appearance, and mixability when rating     cholestyramine and Tang to determine the accuracy and usefulness of a taste test     questionnaire.   "
244958|NCT01062282|"     The purpose of this study is to gain information on safety and efficacy from Korean patients     who starting Ventavis treatment by observational method.   "
244959|NCT01062295|"     NTRODUCTION: The investigators have developed a new device to help passengers of vehicles to     rest, sleep, and to avoid cervical injuries due to sleepiness postures while travelling. The     device is attached to the headrest and is based in a new concept called dynamic vertical     holding of the head and neck. It could also provide some help in avoiding accidents by     allowing a sleeping time for a secondary driver while the main one is driving. Several     studies have shown that up to 30% of car crashes are related to sleepiness.      AIM: To estimate the efficacy and safety of a new device in patent pending phase to     facilitate the sleep and rest in the passenger.      METODOLOGY: DESIGN: Prospective, cross-over and open clinical assay, comparing the results of     40 different passengers during a journey after using both systems, that is the new device and     the standard headrest.      MEASUREMENTS: A) Standard polysomnography for 3 and a half hours during the night; B)     Anthropometric and clinical variables; C) Sleepiness scale and Epworth sleepiness; D)     Questionnaires of sleep, health and quality of life. E) Evaluation of the neck posture in     recorded images.      ANALYSIS: To compare the results of questionnaires of sleep quality, comfort and safety as     well as the images recorded and polysomnographic variables of objective sleep variables     obtained by the device Siesta-SystemTM and the conventional headrest.   "
245060|NCT01068574|"     The purpose of this study is to assess whether the BASIC Scale--a simple, non-invasive     clinical triage protocol--predicts severe illness, hospitalization or death among children     under age five presenting for acute care in a rural African health center.   "
244960|NCT01062308|"     Background and Rationale: The most commonly seen disabilities in stroke patients are shoulder     injuries such as shoulder pain, glenohumeral subluxation, spasticity of shoulder muscles,     soft-tissue trauma, rotator cuff tears, and shoulder-hand syndrome.      Taping is widely used in the field of rehabilitation as both means of treatment and     prevention of sports related injuries. Scarce information is available regarding the use of     shoulder taping in preventing shoulder injuries in stroke patients. Aims:      To find out the effectiveness of taping technique with conventional treatment versus sham     taping and conventional treatment in prevention of shoulder injuries in patients with acute     stroke.      Hypothesis:      Taping technique with conventional treatment will be superior to conventional treatment alone     in preventing shoulder injuries in patients with acute stroke.      Methods Research setting: Stroke unit, department of Neurology, Christian Medical College     (CMC) Ludhiana, Punjab, India and College of Physiotherapy, CMC Ludhiana.      Study design: prospective, randomized, outcome blinded trial (PROBE design). Study period:     Prospective for 18 months from May 2009 All stroke patients with upper limb weakness within     48 hours after the ictus and with Brunnstrom's stage of recovery 1 and 2 will be included in     the study. Patients will be randomized into two groups using lottery method. The treatment     arm group(Group I) include shoulder taping with conventional techniques that is(positioning,     handling technique and passive range of motion exercises) and the control arm (Group II)     include sham taping with conventional techniques with sham taping. A total of 80 patients in     each group will be included. The plastic micropore and elastic adhesive tape will be used for     taping the affected shoulder. The sham taping will be done using the same tapes but without     stretching the concerned muscles and joints. The tapes will be changed every 3 days and will     remain for 14 days. The outcome measures are as follows; Primary: Pain: Visual Analog Scale     and Activities of daily living: Shoulder Pain and Disability Index (SPADI); Secondary: Range     of motion: using a Goniometer. The outcome will be assessed by an independent physiotherapist     who will be blinded to the clinical details. Patients will be followed-up at 14 days and 30     days. Statistical analyses will be done using SPSS software version 16.   "
244961|NCT01062321|"     Hepatitis E virus is a public health problem in several countries of the world where safe     drinking water is a problem. HEV is an exclusive cause of epidemic hepatitis in general     population. HEV infection occurs most frequently in rainy season. The disease affects mainly     young adults in the age of 15-40 years.HEV viral infection is of particular concern in     pregnancy. It is a potential disaster for mother and child. HEV infection during pregnancy is     fulminant and fatal especially if it occurs in third trimester. The mortality in the second     trimester is around 20% and reaches upto 45% in the third trimester.   "
244962|NCT01062334|"     Anastomotic leakage is a serious complication after LAR with high morbidity and mortality     rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to     investigate the clinical use of peritoneal microdialysis and whether is able to detect     anastomotic leakage prior to clinical symptoms.   "
245055|NCT01068509|"     The purpose of this study is to determine the safety and efficacy of an investigational     therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to     determine its ability to prevent cancer from returning.      Study objectives      Primary objectives:        -  To confirm the safety of administering Cvac in this population.        -  To determine the effects of Cvac on progression-free survival (PFS).      Secondary objectives:        -  To determine overall survival (OS) for ovarian cancer patients who receive Cvac after          achieving remission in the first or second-line setting.        -  Evaluation of host immunologic response to Cvac administration.   "
244963|NCT01062347|"     Zinc deficiency is a widespread public health problem in developing countries. The true     prevalence of this condition remains uncertain because of lack of a specific, sensitive and     reliable biomarker for assessment of human zinc status. The most widely used indicator for     measuring zinc status is serum zinc level, which, however, is homeostatically regulated and     influenced by stress and infection. To explore the possibility of using mRNA levels of zinc     responsive genes as an indicator of zinc status, Cao and Cousins suggested metallothionein     (MT) mRNA level in monocytes and peripheral blood mononuclear cells as an indicator of recent     zinc uptake. However, the usefulness of MT mRNA is also limited because its level is     influenced by other metals, such as copper, cadmium and cobalt and it is also affected by     stress. Several authors have proposed that expression of zinc transporter genes might be     useful markers of Zn status. Evidence shows reduction in dietary zinc content produces a     marked increase in intestinal absorption and decrease in intestinal zinc losses. As zinc     homeostasis is regulated in the intestine, study of the zinc transporters in this organ may     provide indication of recent zinc uptake. Recently, a few studies have begun to investigate     the applicability of using white blood cell zinc transporter expression as an indicator of     zinc status and found that some of the transporters are zinc responsive. The primary     objective of this study is to explore whether the expression of zinc responsive genes, such     as zinc transporters in human intestinal mucosal cells, can be used as indicators of zinc     status. The specific aims are to compare gene expression in: a) intestinal mucosal cells     obtained by duodenal biopsy, b) sloughed intestinal mucosal cells isolated from feces, and c)     peripheral blood mononuclear cells (PBMC) in fasting individuals who are receiving their     usual diet + placebo or their usual diet + supplemental zinc (20 mg/d for 7 days). Gene     expression values from intestinal mucosal cells (biopsy) will be compared between the placebo     and zinc supplemented groups. Similar comparison will be done in the cells isolated from     stool and PBMCs. This study will also provide an opportunity to compare the relative     responsiveness of gene expression and serum zinc concentration following supplementation and     to explore the kinetics of any changes in serum zinc concentration. Thus, blood samples will     be obtained for measuring serum zinc concentration on two occasions prior to the     interventions and at specified intervals during and after the intervention.   "
244965|NCT01062373|"     Several recent publications showed a reduction in the level of DHA and/or an increase in the     arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the     polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is     unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas     scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human     milk to explain the beneficial role of the breast-feeding at short, medium and long term. We     will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status     improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA     ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and     n-6 fatty acids pathways.   "
244966|NCT01062386|"     Malaria is one of the major public health problems in Sub-Saharan Africa. In response to this     threat, Roll Back Malaria (RBM) has rolled back a strategy using ACT as first line therapy     for malaria episode, a wide distribution of Insecticide Treated Bednet (ITN), intermittent     presumptive treatment of pregnant women and indoor residual spraying. Recent epidemiological     observations suggested a decline in malaria prevalence in some countries but further     evidences are still needed to confirm this evolution. The RBM strategy requires the use of     reliable rapid diagnostic test (RDT) for which an operational assessment is necessary.     Lastly, home-based management of malaria is also an important compound of this strategy.     However, a better understanding of the actual use of antimalarial drugs, of the use of bednet     and of the barrier to the use of health care is important to implement good quality     strategies for malaria control.      This study is a cross-sectional community based survey made of two rounds (one in January     2010 and the second in June 2010). The general objective is to measure the prevalence of     infection with Plasmodium falciparum at two periods of the year (at the moment of lowest and     highest transmission based on the seasonal rainfalls) and to compare it with the prevalence     estimated in 2004 after the rainy season for the same area. Specific objective are the     estimation of the prevalence by age stratum, the analysis of the geographical distribution of     the infection, the description of the parasitological characteristics, the assessment of     three RDT, the description and the analysis of the prevention and care seek behaviours     related to malaria.      The study area is the great Mbarara district located in south-west of Uganda. A three-stage     cluster sampling method will be used. Spatial information will be collected with global     positioning system and imported to Geographical Information System. Behaviour information     will be collected through face to face interview.   "
245066|NCT01068652|"     This trial is conducted in Africa. The aim of this clinical trial is to investigate the     effect of 50 weeks of treatment with different intensified insulin administrations (all in     combination with a fixed dose of metformin) on blood sugar control in subjects with type 2     diabetes inadequately controlled by oral anti-diabetic drugs (OADs).   "
244967|NCT01062399|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as temozolomide, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Radiation therapy uses high energy     x-rays to kill tumor cells. Giving everolimus together with temozolomide and radiation     therapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when     given together with temozolomide and radiation therapy and to see how well it works in     treating patients with newly diagnosed glioblastoma multiforme.   "
244968|NCT01062425|"     This randomized phase II trial studies temozolomide, radiation therapy, and cediranib maleate     to see how well they work compared with temozolomide, radiation therapy, and a placebo in     treating patients with newly diagnosed glioblastoma (a type of brain tumor). Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Radiation therapy uses high     energy x-rays to kill tumor cells. Cediranib maleate may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.     It is not yet known whether temozolomide and radiation therapy are more effective when given     with or without cediranib maleate in treating glioblastoma.   "
244969|NCT01062438|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study is looking at DNA in tumor tissue samples from patients with     localized or metastatic osteosarcoma.   "
244970|NCT01062451|"     The primary objective is to determine the dose dependent effects of treatment with     perindopril on methamphetamine (MA)-induced craving and on the reinforcing effects of MA     indexed by MA self-administration. We will also determine the effects of treatment with     candesartan on MA-induced craving and on the reinforcing effects of MA indexed by MA     self-administration.   "
245010|NCT01067924|"     The purpose of the study is to assess the effectiveness of motivational interviewing in     promoting maintenance of physical activity in people with Type 2 diabetes (T2D) upon the     completion of a structured exercise program.      Participants with T2D who are new graduates of a supervised exercise program will be randomly     assigned to either standard care (SC) or to standard care and in addition, participate in two     individual motivational interview (MI) sessions (SC + MI).      The primary outcome will be change in physical activity behavior assessed by the Godin     Leisure and Exercise questionnaire. Secondary outcomes will include change in blood glucose     control (A1C), BMI, six minute walk-test, QoL, and self-efficacy.      Outcomes will be measured in groups at baseline, end of program, 3 months and 6 months     post-program.   "
244971|NCT01062477|"     The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined     vaccine in support of registration of this product in China      Primary Objectives:        -  To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4          and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria,          Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine          given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP)          antigens, one month after the three-dose primary vaccination.        -  To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine          administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis          Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with          Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose          primary vaccination.      Secondary Objectives:        -  To describe the safety after administration of the study vaccines.        -  To describe in each group the immunogenicity of the study vaccines one month after the          primary vaccination and before and one month after the booster vaccination.   "
244972|NCT01062490|"     This is a multicenter, multinational, non-randomized, non-controlled open-label phase II     trial to evaluate the safety and efficacy of treosulfan in a combination regimen with     fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in     patients with MDS.      The aim is to demonstrate a clinical benefit compared to historical data with intravenous     busulfan.   "
244973|NCT01056003|"     As known from several observational and retrospective endoscopic studies the prevalence of     gastric inlet patches (GIPs) of the cervical esophagus is estimated between 1-10%. In most     cases GIPs are found within endoscopy as an incident finding, since in most cases they are     harmless and do not cause any symptoms. None the less several data exist where an association     between GIPs and globus sensations is discussed. Case reports even refer to bleeding     complications and moreover to malignant transformations of GIPs.      As a result of the assumed association of GIPs and globus sensations we performed a pilot     trial. Here we included 10 patients with globus and GIPs and were able to demonstrate a     significant symptom relief after ablation of the GIP (Meining et al, Endoscopy 2006). To     exclude a potential placebo-effect we concluded a multicenter and sham controlled trial where     we imposingly were able to prove the symptom relief after ablation of the GIPs (Bajbouj et     al, Gastroenterology 2009).      All patients, who are scheduled for esophagogastroduodenoscopy (EGD) in any of the above     mentioned endoscopical departments are routinely standardized asked whether they have any     hints suggestive for globus sensations (modified globus-questionnaire from Deary et al., J     Psychosom Res 1995). Concurrently it is noted, whether the patients have endoscopical     detected GIP. All GIPs are biopsied and examined in one institute. Together with anamnestic     data (age, gender) a talley sheet gives a survey of all relevant information to prove or     disprove following hypotheses.      Study hypotheses:        1. The presence of GIPs is associated with globus sensations. In other words: Do patients          with globus sensations significantly more often have GIPs?        2. GIPs are not congenital, they arise in the course of the time and become symptomatic. In          other words: Do GIPs significantly occur in more elderly people?        3. The more increased the GIPs diameter is the more likely globus sensations are present?          In other words: Do huge GIPs cause significantly more often symptoms than small ones?        4. The more mucus-producing mucosa is histologically proven the more likely globus          sensations are present? In other words: Do we find more cardiac mucosa in patients with          symptoms than fundus mucosa?   "
244983|NCT01062568|"     In girls with elevated androgens the precise source of androgen excess throughout puberty and     early adolescence has not been carefully examined. The investigators propose to examine     whether the adrenal gland produces the majority of androgens during puberty by studying the     differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in     normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare     steroid changes before, 30 min, and 60 min after ACTH administration in NW and OB girls.   "
244984|NCT01062581|"     Under Transplant Information Services (TIS), the University of Minnesota Transplant Registry     (UMTR) will serve as the repository for core research data.   "
244974|NCT01056016|"     The American Academy of Pediatrics (AAP) has established a set of consensus guidelines for     pediatricians to follow. These guidelines can be challenging to implement in typical     community-based practices. Cincinnati Children's Hospital Medical Center (CCHMC) has     developed a program called the ADHD Collaborative to promote the adoption of these guidelines     among community pediatricians. The program focuses on modifying the office system using     academic detailing and quality improvement (QI) methodology to accommodate prescribed     practice changes. The ADHD Collaborative has been very successful at recruiting practices in     the Greater Cincinnati area, changing practice behaviors, and sustaining these practice     behaviors over time at minimal cost to the project and to the office practice. Now that     sustainability and effectiveness have been established, the next step is to modify the ADHD     Collaborative model to make it amenable to widespread dissemination. The primary goal of the     proposed study is to modify the ADHD Collaborative intervention to make it transportable and     then evaluate this version in terms of effectiveness, consumer satisfaction, and costs.. A     transportable intervention is described that utilizes telehealth videoconferencing, a web     portal, and long-distance data collection. Initially, three pediatric practices will be     recruited to test and refine the distal intervention delivery methodology. Then, eight new     pediatric practices will be randomly assigned to receive the distal intervention or to a     control group (treatment as usual). Information about pediatric practice behavior will be     collected at baseline, 6-months, and 1-year post-baseline. The study design will allow for a     preliminary assessment of the feasibility and effectiveness of the distal intervention in     terms of rates of evidence-based practice behaviors to patients, change in pediatrician     attitudes, consumer satisfaction, and costs.   "
244975|NCT01056029|"     This is an open-label, single-arm, dose-escalation Phase I study to determine the maximum     tolerated dose (MTD) of G-202 (mipsagargin) when administered once daily for 3 consecutive     days of a 28-day cycle in patients with advanced solid tumors. G-202 will be administered by     intravenous infusion over 1 hour on Days 1, 2 and 3 of each 28-day cycle.   "
244976|NCT01056042|"     Patients with endometriosis-associated pain have conservative surgery performed to remove all     visible lesions. Then, patients are randomized into two groups. In the first group patients     have depot medroxyprogesterone acetate injections every 3 months for a total of 6 months.In     the second group patients have oral contraceptive combined pills everyday for 6 months.     Patients are followed up on recurrence of pain for 1 year after medication.   "
244977|NCT01056055|"     This prospective, randomized study was conducted to compare the clinical outcomes of the     modified Brostrom procedure using a suture anchor and bone tunnel for chronic lateral ankle     instability.   "
244978|NCT01062503|"     Bone is the most common site of metastases in prostate cancer and bone complications cause     substantial morbidity to this population. Phase III studies have shown that zoledronic acid     is effective in decreasing the morbidity associated with bone metastases. Zoledronic acid     (ZA) is generally well tolerated but may have side effects such as hypocalcemia, renal     impairment and osteonecrosis of the jaw. Administration of ZA as infrequently as once yearly     is sufficient to prevent osteopenia or osteoporosis. The optimal treatment interval is     unknown, but the drug is often empirically administered every 3-4 weeks. The cost of such     treatment is high, and the risk of exposing patients (especially those at low risk) to     potential serious side effects with uncertain benefit warrants investigation. This study will     determine the duration of suppression of bone turnover in prostate cancer patients with bone     metastases following a single infusion of Zoledronic Acid and its effect on quality of life.   "
245028|NCT01068158|"     The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective     treatment for head lice infestations.   "
245029|NCT01068171|"     The purpose of this study is to determine which treatment, over 6 months, will promote     healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective     way.   "
245070|NCT01068704|"     The purpose of this study is to determine if BMS-690514 + letrozole will be more effective     than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast     cancer after developing progressive disease immediately following adjuvant antiendocrine     therapy   "
244979|NCT01062516|"     The investigators examine the influence of esomeprazole versus famotidine on antiplatelet     action of clopidogrel associated with aspirin. At least 100 consecutive patients suffering     from acute coronary syndrome or undergoing coronary artery stent implantation , who received     aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day or     75mg/day for at least 7 consecutive days), are randomised to receive either esomeprazole 20     mg daily vs famotidine 40 mg daily in a double blinded manner. Clopidogrel effect was tested     by measuring residual platelet reactivity (RPR) to ADP by VerifyNow P2Y12 assay (Accumetrics     Inc, San Diego, Calif). At baseline, whole blood will be obtained for RPR at least 12 h after     clopidogrel loading dose or at least 7 days of maintaince dose. Immediately obtaining the     baseline blood, patients will be randomized to receive either esomeprazole (20 mg/day) or     famotidine 40 mg/day for 28 days. Double blinding will be performed by encapsulation of study     drugs. RPR will be measured again at the 28th day.      The investigators will compare the % inhibition and the P2Y12 reaction Units (PRU) at the     28-day treatment period in the 2 groups.   "
244980|NCT01062529|"     The aim of this study is to investigate peripheral effects of Somatostatin on glucose     metabolism and growth hormone (GH) signalling in healthy men. Eight subjects will be     enrolled. The hypothesis is that Somatostatin infusion reverses insulin resistance caused by     GH.   "
244981|NCT01062542|"     Chemotherapy can damage the ovaries and cause premature menopause. In women treated before     the age of 40 years, menopause does not usually occur. We have very little information about     the impact of chemotherapy on ovarian function in this particular group of women. In this     study, we will check hormone blood tests and ultrasound tests of the ovaries to measure the     reserve of eggs left in the ovaries after treatment in young survivors of breast cancer and     childhood cancer. We will do the same tests in our comparison group. We can use these results     to estimate the reduction in fertility in young cancer survivors.   "
244982|NCT01062555|"     Reducing drug side effects is a key issue in transplantation. One class of drugs commonly     used, calcineurin inhibitors (CNIs), is associated with negative side effects, namely,     toxicity to the transplanted kidney. In some patients, this toxicity is thought to be     associated with loss of transplant function in those who have had their transplants for many     years. The introduction of new immunosuppression medications however, has provided the     opportunity to minimize or avoid CNIs, which may reduce the occurrence of toxicity to the     kidney.   "
245067|NCT01068665|"     This trial is conducted in South Africa, Europe and North America. The aim of this trial is     to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine     (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4     (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic     drugs (OADs) qualifying for intensified treatment.   "
244985|NCT01062594|"     An aneurysm is a permanent and localized dilatation of an artery usually more than 50% of its     normal diameter. Abdominal Aortic Aneurysms (AAA) is an aneurysm of the main artery of     abdomen and affects 5% of men aged 65-74 years. Rupture of an aneurysm is the 10th leading     cause of death in white men over 65 years of age in industrial countries. Treatment of     asymptomatic AAA is considered when the diameter of an AAA reaches 5.5 cm. There are two     treatment options available: conventional open surgical repair or endovascular repair, which     is a less invasive mode of treatment. After the operation heart and lung complications are     significant in patients undergoing major abdominal surgery. The commonest causes of death are     due to heart problems. There are various studies which have shown benefits of pre operative     exercise training in patients undergoing orthopaedic, lung and heart bypass surgery.     Currently, there is no data available with regards to the effect of pre-operative (before     operation) supervised exercise in patients undergoing surgery for an AAA.      The main aim of this study will be to determine whether a pre-operative supervised exercise     programme improves post-operative (after operation) outcome, compared to standard treatment.      Patients will be entered in the study once a decision to repair their AAA has been made by     the consultant. They will undergo pre-operative assessment and will be divided randomly into     two groups. One group will have exercise training for 4-6 weeks before surgery and the other     will not. After the operation they will be followed during the post-operative period to     determine the presence or absence of complications. It is anticipated that complications will     be less in the group which has undertaken exercise training before operation.   "
244986|NCT01062607|"     This study is to provide reliable information on the management of bipolar disorders in real     every day, clinical practice, to determine the clinical outcomes of such management and use     of resources in relation to the disease, and to establish the factors associated with     different management patterns and clinical outcomes.   "
244987|NCT01062620|"     A dose escalating phase Ia-b clinical trial of the IGF-1 receptor inhibitor AXL1717 in     patients with advanced cancer.      The objective is to study the safety and pharmacokinetics of AXL1717 and to define an     appropriate Phase 2 dose for further studies. This is the first study in man. The study is     not designed to show tumor response.   "
244988|NCT01062633|"     This study aims at demonstrating the effect of erythritol and xylitol lozenges on preventing     the new caries lesions and the possible remineralization effect of both polyols on incipient     caries lesions.   "
244989|NCT01062646|"     Multimodal music therapy (MT) for children ages 8 to 12 years with anxiety disorders is     compared to community treatment as usual (TAU). 36 children were randomized either to MT or     to TAU. Primary outcome is presence of an anxiety disorder at the end of treatment. Secondary     outcomes are self- and parent-/teacher reported anxiety, co-morbid psychological symptoms,     and quality of life. Stability of outcome is assessed six months after the end of treatment.   "
245071|NCT01068717|"     To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose     combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin     (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy     participants in the fasted and fed states.   "
245074|NCT01068756|"     The purpose of the study is to assess the effects of rifampin on the pharmacokinetics of     dapagliflozin   "
244990|NCT01062659|"     In order to persist in the liver, HCV has numerous nonspecific and specific strategies to     overcome the immunity of the host. The crucial step in the establishment of viral persistence     and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the     liver. Treatment with pegylated interferon alpha (IFNα) in combination with ribavirin (RBV)     is the standard therapy for chronic hepatitis C is. The response to IFNα / RBV therapy     depends on the effective cellular antiviral immune response in the liver. The understanding     of the interaction between HCV and cellular immune response is important for the effective     use of existing diagnostic techniques, the Individual control and adjustment of the current     therapeutic approaches and the development of future therapeutic and immunization strategies.     In this study, the investigators want to investigate cellular Immune responses in the liver     of HCV infected patients and characterize the influence of these immune responses to the     response to IFNα / RBV therapy.   "
244991|NCT01062672|"     The study's objective is to measure changes in human visual cortex organization that may     arise as a result of injury to the visual pathways. Subjects with retinal or cortical injury     will be studied and compared to appropriate controls. Functional magnetic resonance imaging     methods are used to monitor cortical topography in time. The main aims of the study are to     determine: 1) what are the patterns of cortical reorganization that are seen spontaneously     after injury, and 2) whether rehabilitative training can promote adaptive reorganization     enhancing recovery.   "
244992|NCT01062685|"     The overall hypotheses of this project is that Near Infrared Spectroscopy (NIRS) can be used     to identify morbidity, mortality, and resource utilization in patients with sepsis and septic     shock.   "
244993|NCT01062698|"     THRACE is a controled, multicenter and randomized trial.      The primary objective of this study is to determine whether a combined approach intravenous     thrombolysis (IV) + Mechanical thrombectomy is superior to the reference treatment with IV     thrombolysis alone, in the 3 hours of onset of symptoms in patients with occlusion of     proximal cerebral arteries and with a neurological impairment accident (National Institutes     of Health Stroke Scale [NIHSS] ≥ 10).      The second objective is to determine the cost-effectiveness of this procedure compared to the     standard (IV thrombolysis). The assumption is that the combined approach, by improving the     clinical outcome and speed recovery, allows for lower overall costs to the IV thrombolysis in     3 months and less than or at worst neutral to 1 year.   "
245061|NCT01068587|"     RATIONALE: MET/VEGFR2 inhibitor Foretinib and erlotinib hydrochloride may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow     to the tumor.      PURPOSE: This randomized phase I/II trial is studying the side effects of erlotinib     hydrochloride when given together with or without MET/VEGFR2 inhibitor Foretinib and to see     how well it works in treating patients with locally advanced or metastatic non-small cell     lung cancer that has not responded to previous chemotherapy.   "
245062|NCT01068600|"     This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.   "
245100|NCT01069094|"     A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of     leiomyomata.   "
244994|NCT01062711|"     When we age, we lose muscle. It is not exactly clear why this happens, but we do know that     this muscle loss can increase health risks and lead to health problems. Lifting weights (i.e.     performing resistance exercise) and proper nutrition, in particular eating enough high     quality protein, can help slow the loss of muscle mass or potentially even reverse it.     Protein and resistance exercise are thought to do this by stimulating your muscle to make     more proteins and/or potentially by slowing down the rate at which your body breaks proteins     down. Whey protein is a high quality protein isolated from milk and is known to stimulate new     protein synthesis for all proteins in your body. However, to date, the effect that whey     protein has on muscle protein synthesis, particularly in the elderly has yet to be     determined. Thus the purposes of this study are: 1) to determine if whey is an effective     source of protein that will stimulate muscle protein synthesis in the elderly, similar to     what we have previously seen in young persons; 2) to determine the smallest amount of whey     protein to consume to maximally stimulate your muscle to make new proteins; 3) to see if     performing resistance exercise will augment the increase in new muscle protein synthesis with     whey consumption; and 4) to try and found out if whey is more effective than soy protein in     stimulating new muscle protein synthesis and suppressing muscle protein breakdown in the     elderly, similar to what we have previously seen in young persons   "
244995|NCT01062724|"     The purpose of this study is to analyze if the infants who received Primene solution, have     lower serum levels of methionine and cysteine and higher serum levels of taurine, we also     analyze if the infants who received Primene solution develop TPN-associated cholestasis in a     smaller proportion than those who received Trophamine solution.   "
244996|NCT01062737|"     This study aims to assess the long term (three years) ability of ASU (Avocado Soya     unsaponifiable) to slow the decrease of radiographic JSW (Joint Space Width) in hip     osteoarthritis (OA). This is a randomized, double blind, comparative, parallel group study     versus placebo.   "
244997|NCT01062750|"     Mesenchymal stem cells have capability to differentiate into hepatocyte and will be useful     for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell     compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive     autologous adipose tissue derived stromal cells through intrahepatic arterial     catheterization.   "
244998|NCT01062763|"     The purpose of this study is to estimate the effect of spironolactone on blood pressure     resistant to therapy in type-2 diabetics.   "
244999|NCT01062776|"     1. The distribution and elimination of infusion fluids can be studied by volume kinetics, a          mathematical method based on serial analysis of the blood hemoglobin concentration.        2. The hypothesis of the present study is that the elimination of infused fluid is retarded          in the presence of dehydration, and that volume kinetics would therefore be capable of          detecting dehydration in human subjects.        3. We induce dehydration by injection graded doses of furosemide (a diuretic drug) in          healthy volunteers and the kinetics of an infusion of crystalloid fluid is compared to          when the same volunteer receives the same fluid without being in a dehydrated state.   "
245000|NCT01062789|"     The objective or our study is to test the feasibility of a new optical-based breath-hold     control (OBC) system for monitoring breath-hold levels and providing patient feedback during     CT-guided biopsies of the lung and upper abdomen where respiratory motion is a problem.   "
245001|NCT01062802|"     Aneurysm formation is associated with a chronic inflammatory response, depletion of smooth     muscle cell population and excessive matrix metalloproteinases (MMPs) production.     3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) are lipid     lowering agents with pleiotropic effects including anti-inflammatory activity. Elective open     AAA repair patients will be randomised to receive either statin (Atorvastatin 80 mg) or     placebo (dummy tablet) for 4 weeks pre-operatively. Tissue samples will be obtained from     patient's aneurysm to assess MMP's and their inhibitors TIMP's. It is hypothesized that     patients receiving statin will have reduced MMP's.   "
245002|NCT01062815|"     Hypothesis to be Tested:      Since the first description of intravenous alimentation over half a century ago, parenteral     nutrition (PN) has become a common nutritional intervention for conditions characterized by     inability to tolerate enteral feeds such as Short Bowel Syndrome, Chronic Intestinal     Pseudoobstruction, Microvillus Inclusion Disease, Crohn's disease, multi-organ failure and     prematurity. Parenteral Nutrition-Associated Liver Disease (PNALD) encompasses a spectrum of     disease including cholestasis, hepatitis, steatosis and gallbladder sludge/stones which may     progress to liver cirrhosis and even failure.      There is a direct correlation between duration of parenteral nutrition and development of     cholestasis in infants. There is evidence in animals and humans that cycling of parental     nutrition, defined as infusing nutrients over a time period shorter than 24 hours, reduces     cholestasis. There is also data that premature infants with gestational age (GA) < 32 weeks     and birth weight <1500g, as well as infants with congenital anomalies of the gastrointestinal     tract, are among those at highest risk of developing Parenteral Nutrition-Associated     Cholestasis (PNAC).      We therefore hypothesize that infants with gestational age (GA) <32 weeks and birth weight     (BW) between <1500g, or with congenital anomaly of the gastrointestinal tract regardless of     GA or BW, receiving PN over a period of 20 hours will have a decrease severity of PNAC,     demonstrated by a lower peak direct bilirubin, compared to a similar control population     receiving standard 24 hour infusion.   "
245056|NCT01068522|"     People who survive severe traumatic brain injury (TBI) live with profound cognitive     impairments that alter their developmental course and define their future possibilities.     Worldwide, TBI is the leading cause of death and disability among children and adolescents     (Murgio, 2000). In the United States, the annual incidence of TBI is six times greater than     that of multiple sclerosis, HIV/AIDS, spinal cord injury, and breast cancer combined [Centers     for Disease Control, American Cancer Society, National Multiple Sclerosis Society]. The     burden of TBI may be even greater in developing countries, due to civil unrest and war, and     to the absence of mandated prevention such as seat belt laws.      The long-term objective of the investigators' research group is to improve outcomes for     survivors of TBI in Latin America. To that end, the investigators have created a structure     for professionals and institutions involved in the treatment of TBI to generate research; to     facilitate education, standardization, certification, the dissemination of information and     resources; and to foster the development of evidence-based guidelines. The structure is the     Latin American Brain Injury Consortium (LABIC).   "
245003|NCT01062828|"     Since the first description of citrulline as a potential marker for intestinal function in     1998, its use has been investigated in a variety of disease processes including Short Bowel     Syndrome, Celiac disease, chemotherapy and radiation induced intestinal injury, infections     producing intestinal cytopathic effects like Adenovirus, and predicting rejection in     intestinal transplantation. The use of citrulline levels as a diagnostic tool to predict     gastrointestinal disease in the premature population has not been properly addressed.      The introduction of enteral nutrition in the premature infant is a process of trial and     error, knowing that the immaturity of the gastrointestinal system may lead to frequent     episodes of feeding intolerance. This is augmented by the fear of the development of     necrotizing enterocolitis (NEC) once feeds are commenced. NEC is a condition characterized by     disruption of the intestinal epithelial barrier, a pathogenic process shared with some of the     conditions mentioned above for which citrulline has proven clinically useful.      A normal pattern of citrulline production has not been established in the premature     population. Previous studies have shown decreased levels of glutamine and arginine in     premature infants up to 10 days prior to the development of necrotizing enterocolitis.     Glutamine and arginine are two amino acids closely involved in the synthesis and catabolism     of citrulline.      The investigators therefore hypothesize that defining a normal pattern of citrulline     production in the premature population may prove to be a clinically useful diagnostic tool to     screen for gastrointestinal disease.   "
245004|NCT01067833|"     To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for     up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained     symptomatic atrial fibrillation (AF duration >3 days and <6 months).   "
245005|NCT01067846|"     For this project, the investigators are interested in exploring a new way to extend and     maintain drug abstinence in people who are addicted to crack cocaine. This study will combine     a medication called D-Cycloserine (DCS) and weekly cognitive behavioral therapy (CBT) to     assess whether the combination will enhance people's ability to stay clean (drug free) for     longer periods of time.      One of the greatest risks for drug relapse is drug craving. Oftentimes drug craving occurs     when a person is confronted with stressors and reminders of past drug use behavior. DCS has     been shown to enhance the learning of new information. By administering DCS prior to learning     new techniques such as how to cope with drug craving and drug-use reminders, it is possible     that patients can be more successful at living a drug free life for a longer period of time.      In addition to exploring this model behaviorally, the investigators will explore changes that     may occur in the brain before and after the therapy/medication intervention. A technique     called MRI (Magnetic Resonance Imaging) will be used to identify areas of the brain that are     being activated during an attention task. Areas of neural activation will be assessed at     study entry, end of therapy (4-week endpoint) and one month following completion of the     treatment program.   "
245006|NCT01067859|"     A placebo controlled, double-blind and randomized study to assess different doses of a new     drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the     well-being of patients with acute decompensated heart failure.   "
245007|NCT01067885|"     The MARIS Register is a prospective, multicenter registry of implantation in the superficial     femoral artery (SFA) with a CE marked stent (Maris / Invatec) intended to capture initial     angiographic success, complication rate and symptomatic related revascularization by     following the clinical process and duplex examinations at 6 and 12 month.   "
245008|NCT01067898|"     The purpose of this study is to determine if infrequent administration of oral vitamin D     megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels     of 50-75 nmol/L. The investigators hypothesize that 100 000 IU or at least 200 000 IU vitamin     D3 in every three months would be effective and safe treatment to achieve the target levels.   "
245009|NCT01067911|"     Scientists believe that what happens to dietary fats after they are eaten, especially how     they cleared from the blood, affects risks of heart disease and diabetes is more important     than measuring blood fats after an overnight fast. Little is known about what happens in the     6-8 hours after eating common oils available in Canada such as soybean, canola, olive,     sunflower or flax oils. Vegetable oils have different types of fatty acids. This study will     gather information on what happens to these fatty acids after they are eaten in a meal. The     purpose of this research is to show that clearance of fat from the blood varies with the type     of vegetable oil in a meal.   "
245049|NCT01068431|"     Juxta-Fit is used for compression treatment. Juxta-Fit is an inelastic compression device     which can be easily adjusted to the circumference of the limb and is usually used during the     maintenance phase of lymphedema treatment. The aim of the study is to assess the     effectiveness of Juxta-Fit in the initial treatment phase of leg lymphedema compared to the     traditional treatment with Trico bandages in relation to interface pressure and to explore if     self-management by Juxta fit is efficient after a short demonstration. Data are collected at     0-2-24 hours   "
245011|NCT01067937|"     Despite the fact that appendicitis is one of the most frequent surgical pathology in     children, its clinical management is still debated. Previous reports have shown rate of     appendectomy in children without appendicitis up to 30 %. Morbidity, due to infectious     complications or intestinal obstruction, is often between 5 and 10 % of published cases, and     increase medical and social costs. Evidence-based medicine concept could therefore be     worthwhile in that context, in order to promote rational diagnosis and treatment of that     frequent medical condition.An algorithm describing management of children with suspicion of     appendicitis was established, based on recent published data, in order to reduce delay     between first clinical signs and confirmation of the diagnosis, and to define therapeutic     indication such as conservative management and interval appendectomy or patient requiring     laparoscopic approach. The main objective of the study is to decrease morbidity and     unnecessary appendectomy rates, and secondly to decrease costs, by the use of that algorithm.   "
245063|NCT01068613|"     This study will assess the bronchodilator effects of multiple doses of QAX028 at two     different dose levels when compared to tiotropium and placebo in a COPD population.   "
245064|NCT01068626|"     The purpose of this study is to investigate whether 6 months treatment with the     cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged     men.   "
245012|NCT01067950|"     Current medical therapies are not able to prevent progression of established macroproteinuira     (i.e. diabetic nephropathy) to end-stage renal failure in type 1 (insulin dependent) diabetic     patients. In this setting, proteinuria is a major risk factor for mortality. Pancreas     transplantation, on the contrary, can revert diabetic nephropathy and thereby prevent     end-stage chronic renal failure, with theoretically lower risk of death as compared to     current medical therapies.The main objective of this study is to assess superiority of     isolated pancreas transplantation versus intensive exogenous insulin therapy in type 1     diabetic patients with overt diabetic nephropathy and mildly reduced renal function. The     primary endpoint is a composite efficacy/failure end-point including: patient mortality and     renal function impairment during 5 years in patients with badly controlled diabetes and     nephropathy resisting to up-to-date nephroprotective therapies.Main secondary objectives are     safety and efficacy of both regimens, including proteinuria and renal histology evaluation,     metabolic control and quality of life, acute and chronic extrarenal complications of     diabetes, pancreas survival and all risks related to the transplant procedure (anaesthesia,     surgery and immunosuppression side-effects) and to the intensive insulin therapy management.   "
245013|NCT01067963|"     The purpose of this study is to establish the usefulness and the impact of a tailored     behavioral-education and counseling intervention titled Self-Management and Resourceful     Transition (S.M.a.R.T) among patients with type 2 diabetes mellitus and stage 3 chronic     kidney disease, in order to help them to manage their behaviors related to their condition     and health.   "
245014|NCT01067976|"     The purpose of this study is to look at the efficacy (how does it work) and safety of     gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of     breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the     breasts as MRI may detect additional breast cancers.   "
245015|NCT01067989|"     Low-dose metronomic(LDM)chemotherapy as well as anti-inflammatory agents and bisphosphonates     have shown anti-angiogenic properties on tumor vasculature.      This study is meant to test the therapeutic potential of an anti-angiogenic treatment     strategy by combining all these agents for metastatic breast cancer patients.   "
245016|NCT01068002|"     Cardiovascular & echocardiographic assessment in pregnant women with hypertension during     their pregnancy in comparison to Pregnant normotensive women.   "
245017|NCT01068015|"     The purpose of this study is to evaluate the effectiveness of the community based     comprehensive HIV/STIs intervention among MSMs in China.   "
245018|NCT01068028|"     The purpose of this study is to evaluate the safety and tolerability of multiple ascending     doses of ORM-12741.   "
245019|NCT01068041|"     The primary objective of this clinical study is to evaluate the effectiveness and safety of     PH3 for patients with diabetic nephropathy.      The secondary objectives are to identify the optimal dosage for subsequent studies and to     provide basis for the next confirmatory study in study design, endpoints, and study     methodologies.   "
245020|NCT01068054|"     The study was a double-blind, parallel study to compare efficacy of 0.1% tacrolimus     ophthalmic ointment vs 2% cyclosporine eye drops in children with vernal     keratoconjunctivitis. The duration of the blinded period was 8 weeks followed with 4 weeks of     open-period of tacrolimus ointment. The hypothesis was that tacrolimus was as effective as     cyclosporine for the treatment of this condition.   "
245021|NCT01068067|"     The purpose of this study is to compare pharmacogenetics plus drug combination (Schisandra     sphenanthera extract,SchE)guided and standard initial tacrolimus dosage.   "
245022|NCT01068080|"     The investigators evaluated predictive values of myocardial fatty acid metabolism and insulin     resistance for cardiac death of hemodialysis patients with normal coronary arteries.   "
245023|NCT01068093|"     The purpose of this study is to assess the effects of Ezetimibe on coronary plaque volume in     patients with acute coronary syndrome.   "
245024|NCT01068106|"     The aim of this prospective, randomized study is to compare the efficacy and safety of     biodegradable polymer based limus-eluting stents (BPDES) with permanent polymer based     everolimus eluting stents (PPDES).   "
245025|NCT01068119|"     Same day discharge is safe and feasible in selected troponin negative patients undergoing     coronary planned percutaneous coronary intervention (PCI) or ad hoc PCI via the transfemoral     approach.   "
245026|NCT01068132|"     Italian, multicentre, non comparative trial in patients with advanced Colorectal     Cancer(CRC)and KRAS wild-type, defined by molecular evaluation.      Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity     developed or patient refusal.      The aim of this study is to assess the prognostic role of PTEN in terms of Progression free     survival.      Although the role of Cetuximab as first line treatment in metastatic CRC will be soon     established, it is still unclear which is the best schedule for Cetuximab and the role of     biological factors in order to select the most appropriate subset of pts for recommending     Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the     perspective to study the role of other molecular markers in this subset of pts.      On the basis of these considerations this study is aimed at testing a different schedule of     Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate.   "
245027|NCT01068145|"     Trial to evaluate the dose response of SCH 527123 in reducing inflammation from an     ozone-induced sputum neutrophilia in both healthy subjects and subjects with COPD.   "
245057|NCT01068535|"     The purpose of this study is to compare the vascular permeability of blood vessel walls (of     the carotid artery) in pre-menopausal women who have metabolic syndrome (syndrome of having     at least 3/5 following features- increased abdominal fat, low good cholesterol (HDL-C),     elevated fasting blood fats (triglycerides), elevated blood pressure, an elevated fasting     glucose) versus those women who are normal weight and with normal cholesterol, blood fats,     blood pressure, and blood sugar. We are using a novel technology to measure vascular     permeability known as dynamic contrast enhancement magnetic resonance imaging (DCE-MRI). The     primary variable is ktrans ratio which is a mathematically derived quantity obtained from     DCE-MRI. We are trying to identify novel markers of early atherosclerosis in young women.   "
245058|NCT01068548|"     This is a pilot study to implement a computer based intervention to safely reduce length of     hospital stay and time to conversion to oral antibiotics for patients with pneumonia.   "
245030|NCT01068184|"     AZD6553 is a new drug being developed as a possible treatment for patients with chronic     obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair     of two commonly co-existing diseases of the lungs in which the airways become inflamed and     the small airsacs of the lungs become damaged. This leads to a limitation of the flow of air     to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of     airflow is poorly reversible and usually gets progressively worse over time. There is an     urgent medical need for therapies that could slow disease progression by targeting the     underlying mechanisms associated with the changes in the lungs in patients with COPD. AZD6553     acts by reducing the activity of a protease found to be involved in the disease process in     COPD. AZD6553 is being developed as a novel oral treatment to control the symptoms and     exacerbations of COPD, and reduce the progression and severity of the disease. The purpose of     this research study is to determine how safe and well-tolerated AZD6553 is and how much     AZD6553 enters blood circulation by collecting blood and urine samples during the study. We     are also investigating what AZD6553 is broken down into, when given orally, how much of the     drug is cleared from the body via the kidneys, and the effect of taking the drug after food.     This will all be done by analysis of blood and urine samples taken at various point during     the study.   "
245031|NCT01068197|"     The purpose of this study are to:        1. compare two diet plans - a low-glycemic load (low-GL) diet and a low-fat diet. A low-GL          diet is expected to keep blood sugar levels more normal, and because the sugar levels          stay normal, prevent rapid rises of insulin in the blood. We want to test if Hispanic          children at-risk for type 2 diabetes who are given a low-GL diet will have less insulin          resistance, will lose more weight, and will decrease their chance of getting type 2          diabetes.        2. compare the effects of Low-GL and high-GL meals on appetitive, hormonal, and metabolic          responses of obese Hispanic youth under controlled, standardized conditions. We want to          test if children fed low-GL meals would have lower glucose and lower insulin responses,          report less hunger and consume less energy than those fed high-GL meals.   "
245032|NCT01068210|"     The purpose of the study is look at the effects of different types of exercise training with     a stretching group and its effect on lung cancer patients. Subjects will take part in a 16     week training intervention that can consist of aerobic, resistance, aerobic & resistance, or     a control group. Pre and Post testing will include stress tests, echos, blood, and urine     samples.   "
245033|NCT01068223|"     The purpose of this study is to investigate the effect of JNJ-39758979 compared to placebo on     histamine induced itch in healthy male volunteers.   "
245034|NCT01068236|"     This project will examine the effectiveness of a primary care based intervention to help     overweight teen girls adopt healthy lifestyle practices. Participants are adolescent females     at select Kaiser Permanente Northwest primary care clinics with a body mass index above the     90th percentile. Teens will be randomly assigned to (1) a behavioral weight control program     (enriched intervention), (or 2) usual-care (control). Primary care providers of teens in the     intervention condition are given customized plans describing the teen's eating and physical     activity habits and instructions on how to best work with these teens and their families. The     behavioral weight control program is specifically tailored for teen girls and includes     separate group meetings for teens and parents, follow-up telephone contacts with their group     leader, and coordinated feedback from the teen's primary care provider.   "
245035|NCT01068249|"     The goal of this clinical research study is to learn if the combination of RAD001     (everolimus) and Femara (letrozole) can help to control recurrent or progressive endometrial     cancer. The safety of this drug combination will also be studied.   "
245036|NCT01068262|"     This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked     telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib   "
245037|NCT01068275|"     Randomized trial comparing lumbar plexus catheter versus femoral nerve catheter (single-shot     femoral block as control group) for postoperative pain control after anterior cruciate     ligament repair in children (age 11-21). Primary outcome is pain scores for the first 72     hours. Secondary outcomes include opioid consumption, incidence of opioid side effects and     quality of recovery (previously validated scale). Our hypothesis is that lumbar plexus     catheter will provide superior pain control and overall quality of recovery compared to     femoral nerve catheters.   "
245038|NCT01068288|"     There is no consensus among pediatric surgeons regarding the optimal treatment for children     with complicated appendicitis with delayed diagnosis. With the development of broad-spectrum     antibiotics, some surgeons have advocated expectant management for these children. However,     there is little evidence to determine which children are most likely to benefit from this     approach. Prior attempts to determine the effectiveness of expectant management for     perforated appendicitis with delayed diagnosis often have not controlled for inherent     differences in the clinical status of patients treated non-operatively vs. those treated with     immediate appendectomy.   "
245050|NCT01068444|"     Recent studies have demonstrated that PPARγ as well as diet control could improve glycemic     control, decrease serum ALT level, decrease hepatic fat distribution, and increase     intrahepatic insulin sensitivity. The purposes of this study are:      1. Primary aims:        1. Comparison between Pioglitazone and placebo groups in terms of steatosis and liver          function tests.        2. Evaluation of clinical safety of Pioglitazone      2. Secondary aims:        1. Comparison between Pioglitazone and placebo groups in terms of liver necroinflammation          and fibrosis.        2. The impact of Pioglitazone on the related metabolic index, including insulin          resistance(HOMA-IR), newly-onset diabetes, metabolic syndrome, lipid profiles (T-Chol,          HDL-C, LDL-C, TG).        3. Comparison between Pioglitazone and placebo groups in terms of high-sensitive C-reactive          protein changes.      3. Interventional aim: Assessment the association between magnetic resonance imaging study     and intrahepatic fat distribution before and after Pioglitazone treatment.   "
245051|NCT01068457|"     This is an explorative study investigating potential nerve injury after VATS.   "
245052|NCT01068470|"     Therapy with Interleukin-2 stimulates lymphocytes in humans to become Lymphokine-activated     Killer cells (LAK). This study will determine if these killer cells are able to kill certain     standard cell-lines in the laboratory.   "
245089|NCT01068951|"     The main hypothesis of the investigators study is that the development of autoimmune diabetes     may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.   "
245039|NCT01068301|"     Patients with refractory hematologic malignancies, including those who develop recurrent     disease after allogeneic hematopoietic stem cell transplantation (HSCT) have a dismal     prognosis. Historically, both regimen-related mortality and disease recurrence have been     significant causes of treatment failure in this heavily pre-treated patient population. Novel     therapeutic agents that target molecular signaling mechanisms and increase the sensitivity of     leukemic cells to apoptosis may clearly play a role in this setting.      This study hypothesizes that interrupting the SDF-1/CXCR4 axis using the selective CXCR4     antagonist plerixafor may be useful as a leukemic stem cell mobilizing agent for patients who     are refractory to standard dose chemotherapy and in relapse after an allogeneic transplant.     This hypothesis is based on the dependence of leukemia cells on MSCs for survival signals as     described above and on the preclinical data that suggest increased efficacy by antileukemia     agents when leukemia cells are separated from MSCs.      In the present trial, the study proposes to add plerixafor to enhance the conditioning     regimen cytotoxicity. At this time the goal is to determine the maximum tolerated dose (MTD)     of plerixafor through the process of dose limiting toxicity (DLT) evaluation. Pharmacokinetic     studies will be conducted. Additional studies will quantify and the content of leukemia cells     and key regulatory and effector T cell populations in the bone marrow and blood before and     after exposure to this medication.      If the observed outcomes of this trial are promising, it could serve as a platform on which     to study further use of plerixafor as a complimentary agent with conditioning as well as     other chemotherapeutic regimens for patients with relapsed or refractory hematologic     malignancies.   "
245040|NCT01068314|"     The study hypothesis is that 6 weeks of repetitive handgrip exercise will improve endothelial     function and venous compliance in pre-dialysis patients with an estimated glomerular     filtration rate of less than or equal to 20 ml/min. If proven correct then arm exercise might     be useful to improve the success rate for a surgically created arteriovenous fistula in the     forearm to become usable as a vascular access for hemodialysis.   "
245041|NCT01068327|"     This phase I trial is studying the side effects and best dose of stereotactic radiation     therapy and nelfinavir mesylate when given together with gemcitabine hydrochloride,     leucovorin calcium, and fluorouracil in treating patients with locally advanced pancreatic     cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and     cause less damage to normal tissue. Drugs, such as nelfinavir mesylate, may make tumor cells     more sensitive to radiation therapy. Drugs used in chemotherapy, such as gemcitabine     hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     stereotactic radiation therapy and nelfinavir mesylate together with combination chemotherapy     may kill more tumor cells.   "
245042|NCT01068340|"     The formation of intraperitoneal adhesion following abdominal surgery is accepted by     clinicians as an inevitable consequence. More than 90% of patients undergoing a surgical     procedure in the abdomen will develop intraperitoneal adesions. The incidence however, of     small bowel obstruction (SBO) resulting form these adhesions is far lower. To date, it is     unknown which risk factors predispose these patients to develop SBO. Several have been     proposed, such as age, peritonitis, or surgery for small bowel injury resulting from     gunshots. None of them however, has been widely accepted.      During the last 20 years the significant lifetime risks associated with this phenomenon and     its impact on the quality of life of patients has been well recognized. In addition, the     burden on healthcare resources due to complications caused by adhesions is increasing and     medicolegal consequences are rapidly evolving.      Early SBO following laparotomy for trauma is a poorly described entity. A few retrospective,     single institution studies with a low number of patients have tried to address this issue.     However, these studies either included a subset of trauma patients, i.e. patients sustaining     penetrating trauma,[4] or patients undergoing a negative or non-therapeutic laparotomy, or     examined only the incidence of SBO requiring surgical intervention. In addition, recent data     regarding this issue is lacking, especially after the implementation of the damage control     concept and the other advances in trauma surgery.      The aim of this study is to define the incidence of early SBO following laparotomy for trauma     and to examine possible risk factors associated with its development.   "
245043|NCT01068353|"     The primary aim of the study is to determine the safety and tolerability of etanercept in     subjects with Alzheimer's Disease. The effects of etanercept on cognitive, behavioural,     functional and immunological outcomes will be examined as secondary aims.   "
245044|NCT01068366|"     This study is for patients who have been diagnosed with either a Patent Foramen Ovale [PFO]     or an Atrial Septal Defect [ASD]. These are a type of hole located in the wall that separates     the top two (2) chambers of the heart. You have been recommended to receive an atrial septal     occluder device [a device specifically designed to close PFOs and ASDs] implanted in your     heart to close this hole. Because these devices are made of materials that contain nickel,     this trial is being conducted to perform blood nickel tests on those patients already     referred for an atrial septal occluder device such as yourself. The purpose of this study is     to compare levels of nickel in the blood in patients receiving either the Amplatzer or the     Helex devices.   "
245045|NCT01068379|"     The purpose of this randomized clinical trial was to compare reattachment rates among     patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with     retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.   "
245046|NCT01068392|"     The investigators are willing to investigate the efficacy and safety of oxaliplatin and     prednisolone (Ox-P) combination in patients with previously treated MZL who have a few     clinical trial data.   "
245047|NCT01068405|"     Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years.      At present time,there is no effective treatment against digital arthritis. The investigators     purpose to measure the efficacy of methotrexate on digital arthritis.      In this aim, two groups were compared. The first group receive 10mg/week of methotrexate     administered in one shot (every Monday for example)during 12 months. The second group receive     10mg/week of placebo according to the same procedure   "
245048|NCT01068418|"     Hypothesis: Vitamin D supplementation lower renin-angiotensin system activity in obesity.      Specific Aim: To investigate whether Vitamin D supplementation in obesity improves the     vascular sensitivity to angiotensin II.   "
245068|NCT01068678|"     This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical     trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin     glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or     with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified     treatment.   "
245069|NCT01068691|"     A dissecting or intramural haematoma of the thoracic aorta (AH) is a haemorrhage that     dissects the aortic wall. An entry point is detected at an intimal tear, ulcer or plaque     rupture via imaging in almost 50% of cases. AH occurs in older patients than those with AD     and develops on atheromatous lesions with parietal ulcers, most often in cases of poorly     managed, pre-existing hypertension (HTN). Type A AHs, which affect the ascending aorta,     frequently progress towards an AD with a high risk of mortality, and represent a surgical     indication.      Patients who have presented AD or AH, whether they have been operated or not, must undergo     prolonged monitoring. This involves both clinical and radiological checks to ensure that     blood pressure is properly monitored, that the parietal lesions have receded and that there     are no complications.      HTN is a recognized risk factor for the onset of AD and systolic blood pressure must be     brought down to between 100 and 120 mmHg perioperatively. Furthermore, HTN is also a risk     factor for the rupture of unoperated type B AD. Despite this, only two studies have looked at     BP management in AD patients. The first, carried out among chronic type A or B AD patients     revealed that closer monitoring of blood pressure levels at home led to a better long-term     prognosis. Another study revealed a 60% prevalence of non-managed clinical HTN among 40     chronic AD patients.      Whilst frequent, regular aortic wall monitoring via imaging methods (CT or MRI) is     recommended after thoracic AD surgery, there is no precise recommendation as to the method of     BP monitoring in very high-risk patients. A BP level of 135/80 mmHg has been suggested as a     maximum limit for patients having been operated for AD. In order to achieve this,     antihypertensives of several therapeutic classes must be used, with beta-blockers as a     priority. The same can be said for AH, as it has been demonstrated that the absence of     beta-blocker treatment is a predictive factor for poor progress.      Increased aortic stiffness can cause increased systolic blood pressure and is recognized as     an independent cardiovascular risk factor. This stiffness can be detected by measuring the     carotid-to-femoral pulse wave velocity (PWV). No study has as yet focused on assessing aortic     stiffness in patients who have undergone AD or AH surgery.      Obstructive sleep apnea syndrome (OSAS) in thoracic AD patients is highly prevalent, and     respiratory events that occur are more severe. This has prompted some to suggest that     systematic detection of OSAS after AD should be carried out. No findings have yet been     published about patients who have undergone AH surgery.   "
249031|NCT01115920|"     This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to     evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous     infusion doses of MTP-131.   "
245075|NCT01068769|"     The purpose of this research study is to determine the safety and activity of regorafenib in     participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved     therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug     that blocks abnormally active signaling enzymes called tyrosine kinases which are important     to the growth of GIST. This tyrosine kinase inhibition is similar to the way that both     imatinib and sunitinib work; however, regorafenib blocks certain additional signaling     pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested     in GIST participants before this research study.   "
245076|NCT01068782|"     This is a study of multiple regimens of single-agent XL184 in subjects with grade IV     astrocytic tumor in first or second relapse. The Randomized Phase of the study will evaluate     the safety, tolerability, and preliminary efficacy of four XL184 dosing regimens in separate     study arms. Subjects will be randomized to one of the study arms, which will not be blinded.     After the Randomized Phase, additional subjects will be enrolled to further expand one study     arm in the Expansion Phase.   "
245077|NCT01068795|"     The risk of venous thromboembolism increases in pregnancy. Thrombophilia whether genetic or     acquired, is a hypercoagulable disorder that may increase the risk of venous thromboembolic     events. Clinically, these events are presented as maternal deep vein thrombosis and pulmonary     emboli. Thrombophilias are also associated with adverse fetal outcomes including intrauterine     growth restriction, intrauterine fetal death, severe preeclampsia, placental abruption and     recurrent abortions.      Pregnant women who experienced one or more of the above complications are advised to be     examined for the presence of the genetic or the acquired form of thrombophilia.      Low molecular weight heparin prophylaxis, an anticoagulant, is advised for pregnant women     with a history of thromboembolism, and many experts recommend prophylaxis for pregnant     patients with a known thrombophilia and history of adverse pregnancy outcomes associated with     these hypercoagulable states.      Physiologic changes in normal pregnancy, including weight gain, increased renal clearance and     volume of distribution, may decrease the availability of low molecular weight heparin     (Enoxaparin or Dalteparin), or produce a less predictable response in pregnant women compared     with nonpregnant women. There are no clear recommendations for use of prophylactic low     molecular weight heparin in pregnancy. Clinicians tend to use doses suggested for nonpregnant     patients. Regarding pregnant patients taking enoxaparin or dalteparin, the American College     of Obstetricians and Gynecologists states that because of the lack of data regarding     adequate dosing during pregnancy, anti-factor Xa levels may be monitored.      Two recently published studies demonstrated that plasma anti-factor Xa levels during     pregnancy were lower than expected, indicating that many pregnant patients may receive a     subprophylactic dosing.      Our objective is to check pregnancy outcome among thrombophilic women treated with an     adjusted enoxaparin thromboprophylaxis dosage according to anti-factor Xa plasma levels     compared to women with fixed dosage.   "
245078|NCT01068808|"     The purpose of this study is to evaluate development of allergic rhinitis in children with     nonallergic rhinitis.   "
245079|NCT01068821|"     The purpose of this study is to compare two cushioning materials (a gel mattress and an     egg-crate foam mattress) placed beneath patients undergoing gynecologic surgery to prevent     patients from sliding toward the head of the bed during head-down positioning.      Our hypothesis is that the two materials will be equally good at preventing slide on the     table and that slide will be less than 5 cm (<2 inches) on average.   "
245080|NCT01068834|"     Many patients prescribed statins to lower their cholesterol stop taking their statin over     time. The purpose of this study is to determine whether providing subjects their KIF6 carrier     status (associated with increased cardiovascular event risk) will improve adherence to statin     medications.   "
245081|NCT01068847|"     This study involves giving psychoactive drugs intramuscularly (injected into the muscle of     the upper arm or the hip) and/or orally, and measuring the participant's ability to tell the     difference between one drug and another, as well as measuring the effects of the drugs on     mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each     participant will receive 2-4 of the listed interventions.   "
245082|NCT01068860|"     This was a 10-week, placebo-controlled, randomized study to investigate the effect of     injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or     Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.   "
245083|NCT01068873|"     The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir     (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an     HIV entry inhibitor) for the treatment of antiretroviral naïve HIV infected patients. Twenty     patients will be enrolled and studied for 48 weeks.   "
245101|NCT01069107|"     The main objective of the project is to assess whether a community hospital may have or     should have a role in the Norwegian health care system in the acute treatment of a defined     group of patients.   "
245102|NCT01069120|"     Safety and efficacy study of 25 and 50 mg doses of Proellex   "
245084|NCT01068886|"     Pancreatoduodenectomy (PD) is performed in many high volume centers with a very low     mortality. Reduced mortality rate is largely the result of careful patient selection,     improved intraoperative management and a better postoperative care. Unfortunately, there is     not a similar reduction in morbidity rates which remains about 40%. Persistent morbidity is     predominantly due to pancreatic fistula (PF). Abdominal abscess and hemorrhage are common     sequelae of PF which have been associated with a high mortality rate. While many different     risk factors have been reported, a soft pancreatic texture and a nondilated pancreatic duct     have been most consistently linked to high rates of PF. A number of methods for reducing the     incidence of PF have been proposed and analysed. Many of these involve technical features of     the anastomosis, including site of reconstruction, anastomotic technique, use of biologic     glue, and prophylactic use of somatostatin analogue. The placement of a stent through the     pancreatic anastomosis is an attractive strategy to reduce the PF rate. This multicenter     prospective randomized trial was designed to compare the outcome after PD with external     drainage stent versus no stent in patients with high risk of PF (with soft pancreas and a     diameter of wirsung <3mm).      Analysis:The primary objective of the study was to compare the incidence PF in patients with     or without external pancreatic stent. With an anticipated PF rate of 30%, based on literature     experience, it was calculated that a reduction to 10% of PF rate would require the inclusion     of 75 patients in each group (statistical significance P < 0.05 and power 80 per cent with a     two-tailed test of proportions). We'll enroll 158 patients to take into account the     possibility of 5% being lost to follow-up.   "
245085|NCT01068899|"     The purpose of this study is to standardize methods in measuring a person's energy     expenditure. These methods may be used in a larger study in the future.   "
245086|NCT01068912|"     This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating     the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated     influenza.   "
245087|NCT01068925|"     The purpose of this study is to determine whether there is a drug interaction between     GSK1349572 and the HIV protease inhibitors Tipranavir/Ritonavir (TPV/RTV).   "
245088|NCT01068938|"     The purpose of this study is to compare three perimetric techniques regarding progression of     the visual field.   "
245090|NCT01068964|"     This study will evaluate the safety and efficacy of once daily administered 0.03%     Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03%     Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution     concurrently in patients with open-angle glaucoma or ocular hypertension   "
245091|NCT01068977|"     This is a Phase I, open label, dose-escalation study of MetMAb administered by intravenous     (IV) infusion in patients with advanced solid malignancies that are refractory to or for     which there is no standard of care. The study consists of a dose-escalation stage, an     expansion stage testing MetMAb at the recommended Phase II dose (RP2D), and a dose-escalation     stage testing the combination of MetMAb, at two different doses with bevacizumab at a     recommended dose.   "
245092|NCT01068990|"     This study is a prospective observation study for lower respiratory tract infections in     medical intensive care unit. Microbiologic and clinical characteristics and outcomes of     patients with severe pneumonia in medical intensive care unit will be monitored and analyzed.   "
245093|NCT01069003|"     EDUCATE is a prospective, multi-center study designed to collect real-world safety and     clinical outcomes in subjects receiving one or more Endeavor Zotarolimus-Eluting Stents and     either clopidogrel and aspirin or prasugrel and aspirin as part of a dual antiplatelet     therapy (DAPT) drug regimen.   "
245094|NCT01069016|"     Sacral nerve modulation (SNM) is an established treatment for refractory lower urinary tract     and bowel dysfunction (Spinelli 2008). Pudendal nerve stimulation (PNS) has been proposed for     patients failing SNM treatment of urinary dysfunction (Spinelli 2005). In this study SNM and     PNS are compared for the treatment of fecal incontinence. In a test phase, both treatments     will be applied for one week each in a randomized and blinded order (cross-over design).     After the test phase the more successful treatment will be determined and applied     permanently. If both treatments are equally sufficient, PNS will be chosen for permanent     stimulation, since preliminary data indicate that PNS has a lower power consumption than SNM.     Lower power consumption results in a longer lifetime of the stimulator, thus requiring less     replacement surgeries.   "
245095|NCT01069029|"     The purpose of this study is to compare functional and anatomical results of a combined     surgery and two time surgery for macular hole and cataract extraction in one hundred and     twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic     centers.   "
245096|NCT01069042|"     Hypothesis: Rho, one of the small GTPase proteins, and its downstream target molecule,     Rho-kinase (ROCK), play important roles in mediating various cellular functions, including     contractility, actin cytoskeleton organization, cell adhesion and motility, proliferation,     cytokinesis and gene expressions, all of which are involved in the pathogenesis of     cardiomyocyte contractility and other vascular disease. The investigators thus hypothesize     that ROCK pathway plays an important role in the function and severity of heart failure (HF)     and can be one of the possible pathway that currently applied cardiovascular medicine     affecting their prognosis among HF treatment.      Previous study has shown that in patients with HF, intra-arterial infusion of fasudil causes     preferential increase in forearm blood flow as compared with control subjects, suggesting an     involvement of Rho/Rho-kinase pathway in the increased peripheral vascular HF failure remain     to be examined. Besides, whether the rho kinase activity was enhanced or their response to     current medication in HF patients remained unsolved.      Aim: ROCK activity and left ventricular function between HF or non-HF population survey and     their response to ACEi Tx.   "
245097|NCT01069055|"     The purpose of this study is to determine whether lornoxicam or paracetamol is more effective     in providing pre-emptive analgesia for adult patients undergoing elective unilateral inguinal     hernia repair under general anesthesia.   "
245098|NCT01069068|"     Mandibular advancements during tidal breathing, achieved through a stepped mouthpiece design,     affect the size of the upper airways in subjects with and without Obstructive Sleep Apnea.   "
245099|NCT01069081|"     The objectives of this study are to evaluate the efficacy and tolerability of high dose     proton pump inhibitor combined with chemotherapy in metastatic breast cancer.   "
245104|NCT01069146|"     Objectives: to evaluate the feasibility, the safety and the effects on physiological     parameters of mild therapeutic hypothermia during septic shock.      Design: a randomized, controlled, pilot physiological study. Setting: a 15-beds     university-affiliated intensive care unit of a teaching Hospital.      Patients: twenty ventilated and sedated adults patients with septic shock Intervention: Mild     therapeutic hypothermia between 32 and 34°C during 36 consecutive hours using an external     water cooling blanket.   "
245105|NCT01069159|"     This study will compare the responses of subjects with traumatic memories of varying vintages     to either propranolol or placebo in a double-blind setting. It is hypothesized that those     subjects who receive propranolol will experience less emotional distress when the memory is     subsequently reactivated and less spontaneous re-experiences.   "
245106|NCT01069172|"     The purpose of this study is to evaluate the safety and efficacy of the OptiMedica     Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with     cataracts. The safety and efficacy will be compared to the standard surgical procedure of     continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.   "
245107|NCT01069185|"     Morbidity frequency associated to a endotracheal suctioning is different between a necessity     endotracheal suctioning protocol versus a routine endotracheal protocol.   "
245127|NCT01069458|"     The purpose of this study is to determine whether subjects following a high protein diet will     gain less in weight after smoking cessation compared to subjects following a low fat diet due     to the effects of protein on metabolic rate and hunger.   "
245108|NCT01069198|"     Visceral leishmaniasis (VL) / Kala-azar (KA) is a public health problem in the many countries     in the world including Bangladesh. Where more than 90,000 VL cases have been reported since     1994. The disease is fatal if not treated. Even with treatment the mortality rate is high     (10%). VL is a vector-borne disease, caused by the parasite Leishmania donovani (LD) and is     transmitted by female sandfly sp. Phlebotomus argentipes. Not all people exposed to the LD     parasite develop disease. According to our observation only about 30% of the infected with LD     parasite develop disease within one year of diagnosis. Malnutrition and intestinal helminth     infection have been found to be associated with the risk of active VL. Down regulation of Th1     cellular immune response confers susceptibility to active VL. Both malnutrition and     intestinal helminth infection down regulate the Th1 cellular immune response. Till now there     is no established prophylaxis against active VL among the people exposed to the LD infection.     Many studies including ours have been shown that periodic regular deworming reduced     malnutrition significantly. Micronutrient such as zinc and iron as well vitamin A     supplementation also improve malnutrition and may enhance Th1 cellular immune response. Thus     we hypothesize that periodic deworming and. micronutrient and vitamin A supplementation     together may reduce the risk of active VL among the people exposed to the LD infection.      The study will be carried out in the Harirampur union, Trishal, Mymensingh. This area is     highly endemic for VL. Two hundred asymptomatic VL patients aged 2-60 will be enrolled to the     study. Children aged less than 2 years, pregnant women, active VL case, person with chronic     disease, disable individuals and those who will refuse written consent will not be enrolled     to the study. After enrollment subjects will be divided into two groups through     randomization. One group will receive deworming and nutritional supplement (intervention     group) and other group will receive placebo (placebo group). Two groups will be followed for     12 months through active surveillance for developing of active VL. In addition morbidity     data, monthly stool sampling, monthly anthropometry, urine and blood sampling at baseline,     before and after treatment of active VL will be carried out Successful completion of the     study and derived results from it will provide useful information that whether periodic     deworming with micronutrient and vitamin A supplementation can reduce the risk of active VL     among the people exposed to the LD infection.   "
245109|NCT01069211|"     The purpose of this study is to assess clinical outcomes after Letrozole treatment according     to the estrogen receptor expression in postmenopausal women with hormone receptor positive     breast cancer.   "
245110|NCT01069224|"     Role of proinflammatory factors in Patients with Rotator Cuff Disease      Objective:      To measure the levels of various cytokines and metalloproteases in patients with rotator cuff     disease, and control group and to determine the correlations among them.   "
245111|NCT01069237|"     The purpose of this study is to assess the lens and lens case microbial colonization     associated with marketed care solutions used by experienced soft lens wearers.   "
245112|NCT01069250|"     The aim of the study assesses static and dynamic cerebrovascular autoregulation daily over     one week in patients with traumatic brain injury or intracranial hemorrhage to quantify the     temporal profile of the autoregulatory status.   "
245113|NCT01069263|"     The purpose of this study is to compare the efficacy of hyperbaric oxygen therapy (HBOT) to     intravesical Dimethyl Sulfoxide (DMSO) instillation for the treatment of patients who suffers     from Interstitial Cystitis / Painful bladder syndrome.   "
245114|NCT01069276|"     The aim of the study is to investigate patients with acute stroke prehospital with     transcranial duplex ultrasound to detect an infarct of the middle cerebral artery.   "
245115|NCT01069289|"     The primary purpose of the study is to investigate if Symbicort is more effective than Oxis     in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in     patients with COPD.   "
245116|NCT01069302|"     The purpose of this study is to evaluate the effect of high dose clopidogrel as the     antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for     percutaneous coronary intervention due to ischemic heart disease.   "
245117|NCT01069315|"     The purpose of this trial is to investigate whether irrigation solution (soap vs. saline     solution), or irrigation pressure (high vs. low) will decrease the rate of infection among     patients with open fracture wounds.   "
245118|NCT01069328|"     To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.   "
245119|NCT01069341|"     The purpose of this study was to determine the safety of ranibizumab: a) as a surgical     adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (PDR)     induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (PDR).   "
245120|NCT01069367|"     This is to evaluate immunogenicity based on EMEA/CHMP criteria, and safety & tolerability of     cell-derived A/H1N1 influenza HA vaccine in healthy Japanese elderly subjects.   "
245121|NCT01069380|"     Research objective: to measure resting metabolic rate (REE) in long term, bed ridden,     chronically ill patients and to compare their measured energy needs to standard REE equations   "
245122|NCT01069393|"     The best format for the delivery of structured education for adults with Type 1 diabetes is     unclear. Currently some hospitals invite their patients to attend a 5 day outpatient course     run over one week (Dose Adjustment For Normal Eating (DAFNE)). Other centres offer 1 day a     week for 3 to 5 weeks. We aim to find out whether or not the benefit of benefits are the same     then it would mean that the course could routinely be offered to patients in either format,     thus allowing more patient choice and flexibility.   "
245123|NCT01069406|"     The purpose of the present study is to evaluate the occurrence of first trimester bleeding     among patients with abnormal uterine artery Doppler.      A prospective study is designed and two groups will be studied; patients with abnormal     uterine artery Doppler at second trimester (study group) and patient with normal uterine     artery Doppler at second trimester (control group).The patients will be asked, as part of the     routine history taken before the US about having first trimester bleeding during the current     pregnancy.   "
245124|NCT01069419|"     This is an observational, non-interventional, non-comparative, post-authorization safety     study to evaluate efficacy and long-term safety of Cimzia in adult patients with RA in need     of treatment with a biological product.   "
245125|NCT01069432|"     The purpose of this study is to collect a blood sample from patients with Chronic Lymphocytic     Leukemia (CLL) and from volunteers without CLL.   "
245126|NCT01069445|"     Ageing of the population is a major event in the world. Gerontological/geriatric literature     unanimously indicate that physical exercise and diet are at present the two available     fundamental approaches to contrast/prevent most of the age associated alterations. In the     elderly the inflammageing, the oxidative stress and the alteration of the intestinal     microbiota can be influenced by nutritional status and possibly corrected by an appropriate     dietetic intervention:      Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve     the quality of individual diet for specific needs This study will focus on the development of     a specific dietary approach through an E-Health dietary service, associated or not to     nutraceutical food supplements intake, to modulate the oxidative stress, inflammageing and     gut microflora in the elderly people.   "
245128|NCT01069471|"     Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate     vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity     of the Shigella dysenteriae bioconjugate vaccine (GVXN SD133) alone or in combination with an     adjuvant (Aluminium Hydroxide). The safety and reactogenicity of the GVXN SD133 vaccine will     be also evaluated at two different concentrations of antigen, Shigella polysaccharide O1.     Blood samples will be collected at intervals to examine systemic vaccine antigen-specific     immune responses.   "
245129|NCT01069484|"     Although pregnancy and childbirth are associated with happiness and a positive life change     for most women, it can also be considered as risk periods for injuries to the pelvic floor     and development of pelvic floor dysfunction. This may leed to devastating loss of function     and quality of life (Ashton-Miller & DeLancey 2007).      The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training     for primiparous women with and without pelvic floor muscle injury.   "
245130|NCT01069497|"     STUDY HYPOTHESIS : An infection prevention program adapted for the nursing home context can     reduce by 5% the number of infections (urinary, upper and lower respiratory and     gastrointestinal) in elderly residents in nursing homes.      STUDY DESIGN : The proposal is for an interventional cluster (nursing home) study comprising     2 randomized groups: group 1 (interventional), comprising 25 nursing homes implementing a     specific infection prevention program; and group 2 (control), 25 nursing homes continuing to     implement their routine prevention measures.   "
245131|NCT01069510|"     The purpose of this study is to see if the study drug called spironolactone reduces fibrous     (stiffening) in heart muscle tissue and improves heart function. Subjects from the study     titled Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis who have     evidence of heart dysfunction and/or evidence of fibrosis (stiffening) in the heart muscle     will be asked to take part in this study.      This study will include randomizing the subject to receive the study drug or placebo.     Randomization will occur during visit 1.      Visit 1 will include the following:        -  Subjects will answer questions about how well they can breathe.        -  An MRI. Dye called gadolinium will be injected into the subject's vein.        -  They will go to the Oregon Clinical and Translational Research Institute where 2          tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).        -  They will do a 6 minute walk test..        -  They will also have an echocardiogram, which is a test that looks at the movement of the          subject's heart. A technician will place a cool jelly on their chest and use a small          wand to take pictures through the skin.      Subjects' will also have visits 3-6 weeks, 3, 6, 9 months, and 12 months after randomization.     Visits 2-5 will include the following:        -  They will go to the Oregon Clinical and Translational Research Institute where 1/2          tablespoon of blood will be drawn.        -  They will do a 6 minute walk test. During this test, they will walk back and forth in a          hallway. The goal is to walk as far as possible for 6 minutes. Subjects will probably          get out of breath or become exhausted. If they do, they can slow down, stop, or rest as          they need to. Blood pressure will be taken before the walk.        -  They will have a health review at 6 months.      Visit 6 will be identical to visit 1 and include the following:        -  Subjects will answer questions about how well they can breathe.        -  An MRI. Dye called gadolinium will be injected into the subject's vein.        -  They will go to the Oregon Clinical and Translational Research Institute where 2          tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).        -  They will do a 6 minute walk test..        -  They will also have an echocardiogram, which is a test that looks at the movement of the          subject's heart. A technician will place a cool jelly on their chest and use a small          wand to take pictures through the skin.      The investigators will compare the study drug, called spironolactone, to placebo with regard     to any changes in heart stiffening and function of the heart.   "
245132|NCT01069523|"     All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity     Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have     an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After the     baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel     groups trial. During this trial, dosing will be flexibly adjusted according to patient     response or presence of side effects. The dosage will range from 1-4 mg. At the end of the     four week trial, a follow up ERP study will be obtained.   "
245133|NCT01069536|"     Study Objective:      The purpose of this study is to compare the effects of metoclopramide administration in bolus     versus slow infusion medications in ED patients complaining of nausea for the determination     of the therapeutic effect and prevention of akathisia.      Methods:      This was a prospective, randomized, double-blind trial. The investigation was held between 01     March 2007 and 01 May 2008, in the Emergency Department of Pamukkale University Faculty of     Medicine. The patients with moderate to severe nausea randomized and divided into two groups     as for the previously planned administration type of drug. Ten mg metoclopramide was     administered in one group with slow infusion (SIG) in 15 minutes, via 2 minutes bolus     infusion (BIG) into the other group. Whole procedure was observed, akathisia and nausea     scores and vital changes were recorded.   "
245150|NCT01069770|"     The purpose of this study is to see whether neoadjuvant administration of Sunitinib reduces     the size of the primary kidney tumor in patients with metastatic disease undergoing     cytoreductive surgery. The study will also assess the safety of neoadjuvant Sunitinib,     objective response rate, respectability of primary tumor, quality of life, and survival     advantages.   "
245151|NCT01069783|"     The purpose of this trial is to determine the efficacy and safety of A3309 administered to     patients with dyslipidemia (high cholesterol levels).   "
245152|NCT01069796|"     Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive     bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have     received adjuvant chemotherapy).   "
245134|NCT01069549|"     India is the Diabetes Capital of the World with 41 million Indians having diabetes, with     every fifth diabetic in the world being an Indian and type 2 Diabetes Mellitus (T2DM)     constitutes the major chunk of diabetes. One of the most severe complications of diabetes is     the development of diabetic nephropathy. Diabetic nephropathy (DN) is the leading cause of     end-stage renal disease (ESRD) worldwide. There are many identifiable risk factors of     diabetic nephropathy like hyperglycemia, hyperlipidemia, hypertension, and proteinuria, the     genetic factor is the main among all. Long-term observational studies show that nearly 30-35%     of type 2 diabetic patients develop nephropathy, irrespective of glycemic control. The     regional variation in diabetes prevalence and in the proclivity for diabetes induced renal     disease; along with reports of familial clustering of nephropathy suggest a possible genetic     basis. The renin-angiotensin system (RAS) has been strongly implicated in the pathogenesis of     progressive renal diseases. In addition, the blockage of angiotensin II with either ACE     inhibitor or an angiotensin type-I receptor antagonist has been found to prevent or delay the     progression of renal injury associated with diabetes 5 and now these drugs are first-choice     drugs for the treatment of diabetic subjects with hypertension. The genes encoding the     renin-angiotensin system (RAS), such as angiotensin-converting enzyme (ACE), angiotensinogen     (AGT) and angiotensin II receptor type 1 (AGTR1), have been reported to be the most probable     candidate genes for diabetic nephropathy. As there is no data available for AGTR1     polymorphism and DN in the north Indian T2DM, its out attempt to fill the scientific gap.   "
245135|NCT01069562|"     With the advancement in microprocessor technology and better understanding of     pharmacodynamics and pharmacokinetics of anaesthetic agents, computer facilitated closed loop     control of anaesthesia using propofol has been shown to be accurate with better performance     than manual control. Literature on computer controlled administration of inhalational     anaesthetics is few, as it requires the computer to control the dial setting on the     vapouriser. The investigators intend to compare the computer controlled closed loop     administration of isoflurane by infusing it into the anaesthetic circuit with conventional     vaporiser control in elective open heart surgery.      40 patients (ASA (American Society of Anesthesiology) class II-IV; 18- 65 years) undergoing     elective cardiac surgery requiring cardiopulmonary bypass (CPB) will be randomly divided into     manual or closed loop groups. Propofol will be used for induction of anaesthesia in both     groups followed by isoflurane for maintenance. In the manual group, isoflurane will be     administered through the Tech 7 vapouriser during pre and post CPB periods to target     bispectral index (BIS) of 50. In closed loop group, isoflurane will be administered using     infusion of liquid isoflurane into expiratory limb of the closed circuit. This rate of     infusion though a conventional syringe pump will be controlled by algorithm termed     'Improvised Anaesthetic Agent Delivery System' (IAADS) to maintain BIS of 50. Patients in     both groups will receive 500ml of 100 % oxygen as fresh gas flow. The % of time bispectral     index (BIS) is within the 10 of set target BIS of 50 will be the primary outcome measure. The     secondary outcome measures will be median performance error (MDPE)(2), median absolute     performance error (MDAPE)(2), wobble(2), divergence(2), amount of isoflurane used and     hemodynamic parameters will be secondary outcome measures.   "
245138|NCT01069601|"     The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(R) in     immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is     expected that when administered twice the vaccine fulfills all serological efficacy criteria     required for the elderly population age 60 years and older.   "
245139|NCT01069614|"     A skin stretching device has been designed to stretch tissue prior to surgery, during surgery     and in order to secure wounds following surgery. The device may be used in non-invasive and     invasive applications.   "
245140|NCT01069627|"     This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients     with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic     disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week     cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks     rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study     treatment is until disease progression, and the target sample size is <100 individuals.   "
245141|NCT01069640|"     The purpose of this study is to evaluate the safety, tolerability, immune response and     clinical efficacies of HLA-A*0201 or HLA-A*0206 restricted epitope peptides URLC10 emulsified     with Montanide ISA 51 for advanced non-small cell lung cancers.   "
245142|NCT01069653|"     The purpose of this study is to evaluate the safety, tolerability, immune response and     clinical efficacies of HLA-A*2402 restricted epitope peptides CDCA1 and KIF20A emulsified     with Montanide ISA 51 for advanced small cell lung cancers.   "
245143|NCT01069666|"     The purpose of this study is to determine knowledge base in diagnosis, investigation and     treatment of pediatric atopic dermatitis among thai pediatricians.   "
245144|NCT01069692|"     This study will compare placebo to 4 different doses of SBR759 to assess the phosphate     lowering efficacy in dialysis patients.   "
245145|NCT01069705|"     This is an open-label, single arm (uncontrolled) study in patients suffering from cystic     fibrosis, who have completed their study participation in CTBM100C2303 and extension study     one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at     enrollment into CTBM100C2303.   "
245146|NCT01069718|"     This is a research study to determine if an experimental device called the NTrainer can     improve oral feeding skills more quickly and more effectively than traditional methods in     infants who are at high risk of feeding dysfunction and delayed hospital discharge.   "
245147|NCT01069731|"     This is a research study to quantitatively assess the development of non-nutritive suck (NNS)     and feeding readiness in preterm infants using a novel device, the NTrainer©, and to compare     this with two clinical assessment tools, NOMAS and EFS.   "
245148|NCT01069744|"     The development of sucking behaviors in preterm infants is thought to reflect neurobehavioral     maturation and organization. From a clinical perspective, the ability to feed depends upon a     coordinated sucking, swallowing and breathing pattern. In preterm infants less than 32 weeks     gestation, this ability is not usually effective enough to sustain full oral feeds. In the     interim, infants are fed by gavage tube until they are mature enough to take milk directly     from the breast or bottle (Pinelli, Symington, 2005). Non-nutritive sucking has been used     during gavage feeding and in the transition from gavage to breast/bottle feeding. The     rationale for this intervention is that non-nutritive sucking facilitates the development of     sucking behavior and improves digestion of enteral feeds.   "
245149|NCT01069757|"     This is a phase I study to determine the safety, tolerability and recommended phase II dose     of ARQ 197 given in combination with erlotinib as primary endpoints in patients with     advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor     activity of ARQ 197 administered alone or in combination with erlotinib will also be     determined as secondary endpoints.   "
245153|NCT01069809|"     The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune     therapy, for HIV-infected individuals. Safety and effectiveness will be tested while the     individuals are both taking antiretroviral therapy (ART) medication and interrupting ART     medication.   "
245154|NCT01069822|"     The main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug     being developed for the treatment of patients with severe major depressive disorder) has on     the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your     body and acts in the body.)   "
245155|NCT01069835|"     The overall aim of the study is:      To provide accurate and reliable information regarding NSCLC clinical management across     Central Eastern European countries and Russia in order to detect unmet medical needs of this     disease in terms of:        -  Patient and hospital characteristics.        -  Diagnostic and treatment approaches: initial and subsequent.        -  Follow-up patterns in clinical management.        -  Outcomes: symptoms, death, functionality, quality of life.        -  Use of resources and burden on patients and health care systems. Addendum objective is          to collect epidemiological data on EGFR mutation status (M+, M-) in the Russian          population   "
245156|NCT01069861|"     Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will     reduce the need for inhaled nitric oxide.   "
245157|NCT01069874|"     Purpose: The study null hypothesis is that vitamin D supplementation will not influence time     to acute respiratory tract infection in sheltered accommodation residents.   "
245184|NCT01070238|"     The study was conducted        1. to investigate the superiority of isomaltulose in reduction of postprandial          hyperglycemia        2. to describe the kinetics of glucose absorption after a load of isomaltulose        3. to demonstrate the safety of a single load of isomaltulose compared to sucrose in type 2          diabetic patients.   "
245158|NCT01069887|"     Hema e-chart is an electronic case record that can be changed in real time and is based on     the chronological organisation of the infective events and the therapies prescribed. It     allows the collection of all personal, epidemiological, diagnostic and therapeutic data     pertaining to the patient, processing it and analysing the results.      Aims and objectives of the project      The aims of this registry are:        -  To assess how many suspected fungal-related febrile episodes identify an infective          fungal agent        -  To have a clear view of the diagnostic and therapeutic actions in the management of          onco-haematological patients with suspected fungal-related febrile episodes        -  To assess the impact of anti-fungal therapy on the timing of chemotherapy and transplant          planning        -  Perform drug-epidemiology relationship analyses, observe toxicity and interactions with          antifungal therapies by means of the creation of a national database of fungal          infections in patients affected by malignant haemopathies      Design        -  A multicentre, prospective registry for monitoring invasive fungal infections in          onco-haematological patients        -  Registration criteria: patients with newly diagnosed malignant haematological diseases          (acute and chronic myeloid and lymphoid leukaemia, multiple myeloma, non-Hodgkin's and          Hodgkin's lymphoma, aplastic anaemia, myelodysplastic syndromes), or patients who, as a          result of onco-haematological pathologies, have undergone allogenic or autologous          haematopoietic cell transplants, and have ongoing febrile episodes . The recording of          consecutive febrile events is required        -  Data collection for each individual patient will be performed according to the method          shown in the enclosed flow chart. In the case of a new episode for an existing patient,          said new episode will be recorded in the same case record as a new event. All collected          data will be coded into the database        -  Information relating to about 500 suspected fungal-related febrile events requiring          antifungal therapy is expected to be collected from approximately 60 centres over the          course of 18 months        -  Data collection for each event may be performed following the provision of written          informed consent, which will be obtained from each patient participating in this health          survey        -  The data collected will be handled and stored in full compliance with the Italian laws          governing privacy        -  Hema e-chart is a non-interventional registry   "
245159|NCT01069900|"     The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin     in a pediatric population 3 months to <18 years old. Approximately 450 pediatric subjects     with a complicated intra-abdominal infection will be enrolled in the study and treated with     either moxifloxacin intravenously and orally if switched to oral therapy or ertapenem     (intravenously) and, if switched to oral therapy, amoxicillin/clavulanate.   "
245160|NCT01069913|"     The purpose of this study is to measure two different formulations of BG00012 to determine     how much of each formulation of BG00012 reaches the blood stream and how long it takes the     body to get rid of it, when given as a single dose.   "
245161|NCT01069926|"     To assess the pharmacokinetics of AZD1656, and its metabolite, in type 2 diabetes mellitus     patients with varying degrees of renal impairment and to compare the results with those in     patients with normal renal function.   "
245162|NCT01069939|"     To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous     treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily     Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric     and/or duodenal ulcers.   "
245163|NCT01069952|"     This study will evaluate the safety and efficacy of deep brain stimulation in treating people     with several and otherwise treatment-resistant depression.   "
245164|NCT01069965|"     This is a safety and dose finding efficacy study to evaluate the effects of BGP-15 over the     dose range of 100 mg/day to 400 mg/day. Doses are applied once or twice a day for 13 weeks as     add-on therapy to the combination of metformin and sulfonylurea treatment or metformin alone     in patients with Type 2 Diabetes Mellitus.   "
245165|NCT01069991|"     The goal of this study is to help adolescents with asthma learn to control their illness and     live without restrictions. We hypothesize that an intensive school-based asthma education     program for students in 9th and 10th grade who have persistent asthma, together with asthma     education for their primary care physicians, will improve the students' health status,     quality of life, and ability to control their asthma through self-management.   "
245179|NCT01070173|"     The investigators hypothesize that low serum ghrelin levels may characterize a group of     patients with poor weight gain and/or linear growth who do not have any other identified     cause for growth failure. These patients may present with a variety of complaints and are     often evaluated by both pediatric endocrinologists and pediatric gastroenterologists. The     investigators hypothesize that ghrelin has a physiologically important role in linear growth     and that chronic diseases of the gastrointestinal system, such as H. Pylori infection or     celiac disease, may alter serum ghrelin levels in children. Low ghrelin levels may be a     factor leading to poor growth, potentially by altering growth hormone secretion and/or by     decreasing appetite. By measuring ghrelin levels in children with short stature and in     children with gastrointestinal disease, the investigators will further elucidate the possible     physiologic role of ghrelin in childhood growth and how it may be altered in conditions     causing short stature and in certain gastrointestinal diseases.   "
245384|NCT01071798|"     This prospective observational study aims to evaluate safety, application and onset of effect     of rituximab in clinical routine treatment of severe active rheumatoid arthritis during the     first 6 months (in case of re-therapy: 12 months).   "
245166|NCT01070004|"     Sleep deprivation induces degradation of night-time driving ability via sleepiness. Because     of conflicts between physiological needs and social or professional activities, it is     necessary to develop affordable countermeasure to sleepiness. In real-life driving studies,     nap and coffee are efficient countermeasures of sleepiness at the wheel. However the effect     of caffeine is quick but brief and varies between individuals. There is a need for more     knowledge in order to know what to recommend to drivers. Exposure to 460-nm monochromatic     light (blue light) decreases subjective sleepiness and improves performances. One objective     of this project is to investigate whether blue light exposure during driving would be useful     in a real driving situation when sleepiness becomes acute. Owing to the fact that our     knowledge of the effects of exercise on driving is very sparse and to the absolutely need to     standardize the bouts of exercise that will be applied to the subjects. One objective of the     present study will be to investigate in a simulator study the effects of a bout of moderate     exercise on participants driving ability when sleepiness becomes acute. Nocturnal     neurobehavioral performance varies widely between individuals and only certain subjects seem     significantly affected by sleep loss. It is of interest to find biological markers for sleep     drive to identify vulnerable drivers to sleep deprivation or to identify responders to     sleepiness countermeasures (i.e., coffee and blue light). One objective of this study is to     determine individual differences (genetic, hormonal and cognitive) in the impairment of     driving skills induced by sleep loss and in the efficiency of countermeasures (blue light and     coffee).   "
245167|NCT01070017|"     Using quantitative and qualitative data, this study will assess the impact of community     accompaniment with supervised antiretrovirals (CASA) on HIV-positive individuals and     community members in Lima, Peru.   "
245168|NCT01070030|"     This study assessed the efficacy and safety of combination therapy of Aliskiren/Amlodipine or     Aliskiren/Amlodipine/Hydrochlorothiazide in patients with stage II Hypertension.   "
245169|NCT01070043|"     The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg     amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood     pressure in Taiwanese patients.   "
245185|NCT01070251|"     This study investigates whether a preschool-based physical activity intervention involving     parents as active agents of behavioral change affects objectively measured physical activity     in preschool children.   "
245186|NCT01070264|"     Tahitian Noni Juice (TNJ) made from Morinda citrifolia (noni) fruits may provide a safe     adjunctive treatment for osteoarthritis (OA) due to its anti-inflammatory and analgesic     properties. In this study the investigators examined whether TNJ was able to improve the     symptoms and quality of life (QOL) of OA patients. The investigators also sought to evaluate     the tolerability and safety of TNJ.      This was an open label three-month intervention pilot study. Data were collected by pre and     post intervention survey as well as laboratory testing. Inclusion criteria were: adults of     both sexes aged 40 to 75, with a diagnosis of OA on the hip or knee by their primary care     physician, not on prescription medicine for OA, and who were willing to drink 3 oz of TNJ a     day.   "
245170|NCT01070056|"     Poorly controlled hypertension (HTN) remains one of the most significant public health     problems in the United States, in terms of morbidity, mortality, and economic burden. Despite     compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC)     on blood pressure (BP) reduction, their effectiveness remains untested in primary care     practices, especially among minority patients who share a greater burden of HTN-related     outcomes including chronic kidney disease, stroke and heart failure. This randomized     controlled trial offers a unique opportunity to address this gap in the literature. Among 200     hypertensive African-Americans who receive care in community- based primary care practices,     we will test the effectiveness of a culturally-tailored comprehensive therapeutic lifestyle     intervention, delivered through group-based counseling and motivational interviewing     (MINT-TLC) vs. Usual Care (UC). MINT-TLC is designed to help patients make appropriate TLC     and develop skills to maintain these changes long-term. Patients in the MINT-TLC group will     attend weekly group classes focused on TLC for 12 weeks (intensive phase); followed by     individual motivational interviewing (MINT) sessions for 3 months (maintenance phase).     Trained research personnel will deliver MINT-TLC with appropriate treatment fidelity     procedures. Patients in the UC condition will receive a single individual counseling session     on TLC and print versions of the intervention materials. The primary outcome is     within-patient change in both systolic and diastolic blood pressure from baseline to 6     months. Secondary outcomes are levels of targeted therapeutic lifestyle behaviors; and     proportion of patients with adequate blood pressure control at 6 months   "
245171|NCT01070069|"     To determine the safety and effectiveness of PEVAR.   "
245172|NCT01070082|"     Pain associated with procedures performed on adult ICU patients is ubiquitous and the subject     of research attention.While there is growing evidence about the prevalence, characteristics     and measurement of procedural pain in ICUs, most of this evidence has been derived from     English-speaking patients in the United States who were able to verbally report the intensity     and distress of this pain. Frequently performed procedures include turning,chest tube     removal,wound care/wound dressing change,endotracheal suctioning,central catheter     insertion(arterial/venous, have been a focus for research. Other potentially painful     procedures, including lumbar puncture and physiotherapy,are numerous and have not been     systematically studied in adults.      Patients unable to verbally report their pain have not been able to participate in procedural     pain studies, which has limited the generalizability of study results to a narrow population     of ICU patients.      The Specific Aims of this proposed European-based, international study of ICU patients     undergoing selected procedures are to:        -  Describe patient self-reports of pain intensity and distress        -  Describe the behaviors exhibited by patients during a procedure, comparing the behaviors          exhibited by those able versus unable to self-report pain intensity and pain distress        -  Examine predictors of amount of pain intensity, behavioral responses, and analgesic use          related to procedures such as gender, age, language spoken, country, and type of          hospital.      Validated pain intensity, pain distress, and behavioral observation instruments will be     methodically translated into the predominant languages spoken in our international study     sites; research and training packets similar to those developed in a large, multisite study     in the United States will be developed and provided to data collection sites; and data     collection will occur over a 6-month period of time. Study data will be analyzed and     disseminated at international meetings and in publications.   "
245180|NCT01070186|"     This study is designed to explore the molecular modulatory effect of Sunitinib when given in     a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate     aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery     2-4 weeks following the last dose.   "
245424|NCT01072318|"     The purpose of this study is to assess Efficacy and Safety of Extended Adjuvant Treatment     With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who     Complete 5 Years of Toremifene   "
245173|NCT01070095|"     Asthma is a common and potentially fatal chronic disease. An asthma action plan (AAP) is a     written plan produced by a physician for a patient with asthma, to provide education and     guidelines for self-management of worsening asthma symptoms. Studies have shown that AAPs     effectively improve asthma control, but physicians fail to provide AAPs due to lack of time     and adequate skills. Physicians also often fail to determine if their patients have good     asthma control, and to adjust medications in response to patients' control level. The     investigators propose to develop and test a computerized tool that will help physicians to     determine if their patients' asthma is well controlled, advise them on medication changes     required according to the current level of control, and automatically generate an electronic     version of the AAP, all based on patient responses to a questionnaire. The investigators hope     that this system will eliminate the barriers that physicians face in determining asthma     control, adjusting medications, and delivering an AAP, and will increase the frequency with     which physicians are able to achieve these goals in patients with asthma. The objectives of     the study are to determine the impact of this system on asthma action plan delivery by     primary care physicians, the frequency of checking control level, and the frequency and     appropriateness of asthma medication changes (in accordance with control). We will also     attempt to determine the impact of the system on hospitalisations, emergency room (ER)     visits, unscheduled visits to the doctor, total visits to the doctor, days off work or     school, nocturnal asthma symptoms, daytime asthma symptoms, daytime rescue puffer use, and     quality of life, and to measure physicians' perceptions of and satisfaction with the system.   "
245174|NCT01070108|"     Ketamine affects postoperative pain when administered intravenously immediately before,     during or at the end of surgical procedures. We assessed the effects of multiple and     escalating doses of ketamine administered many hours before surgery on postoperative pain and     analgesia consumption.   "
245175|NCT01070121|"     To stimulate collaborative efforts of federal funding agencies, voluntary health agencies,     professional organizations and industry partners to enable creation of a large, sustainable     database and repository to better understand the molecular basis of treatment and rapidly     accelerate translational research in RA.   "
245183|NCT01070225|"     Current therapies for the management of asthma include inhalers. Types of these medications     (beta agonists), improve asthma symptoms by stimulating areas (receptors) within the human     airway resulting in dilation of the human airway. Whilst these drugs are highly effectively     in the immediate setting their longterm use, constantly stimulation of receptors within the     airway has been associated with increased asthma exacerbations and rare cases of death.      Conversely medications that block receptors within the human airway (betablockers)have been     avoided in asthma.      The main reason for this is because of the possible acute airway narrowing that can occur     after soon after administration. However chronic use of betablockers in asthma has recently     been shown to be of benefit in reducing airway inflammation which is of great importance in     improving asthma control and reducing symptoms.      Despite this early evidence supporting chronic use of beta blockers in asthma, there is     concern in 2 major regards:their potential to cause acute airway narrowing (irrespective of     longterm benefit) and the possibility that they could block the reliever action of beta     agonists.      The objective of this study is to establish how best to reverse the short term effects of a     single dose of beta blocker.      This study is designed as a single centre study, with participants attending the department     on approximately 3 separate visits (including a screening visit) at approximately 1 weekly     intervals.   "
245176|NCT01070134|"     Background:      According to the WHO, major depressive disorder is the second largest healthcare problem     worldwide in terms of disability caused by illness. It afflicts an estimated 17% of     individuals during their lifetimes at tremendous costs. A number of depressive patients are     treated with antidepressant medication. The efficacy of antidepressant medication has been     studied in a number of systematic reviews, and in recent years some of these reviews have     shown that the efficacy is questionable for many patients. So are there other effective     treatments for this serious illness?      Cognitive- and psychodynamic therapies are probably both significantly more effective for     depression than no treatment, but only limited comparisons have been made between the two     interventions. A Cochrane review shows that cognitive therapy has a preventive effect against     recurrent depression, and that this effect may surpass the preventive effect of     antidepressant medication. Mindfulness training may be an effective technique in preventing     relapse in patients who have had at least 3 previous depressive episodes. But efficacy in     treating currently depressed patients has not been studied.      Objective To perform a randomised clinical trial with blinded assessment of efficacy     variables in order to study the effects of mindfulness based behavioral therapy (cognitive     therapy and mindfulness) versus psychodynamic therapy in depressive patients.      Methods      A randomised clinical trial of 84 consecutive patients diagnosed with major depressive     disorder, referred to the day clinic, Roskilde psychiatric services. The patients will be     randomised to one of two interventions:        1. MIBT (mindfulness-based behavioural therapy)        2. PT (psychodynamic therapy)   "
245177|NCT01070147|"     The primary goal of this study is that the combination of a computerized asthma reminder     system with implementation of an guideline will increase utilization and adherence of     guideline-driven care, leading to improved patient outcomes.      Hypothesis: An automatic, computerized reminder system for detecting asthma patients in the     pediatric ED will increase guideline adherence compared to paper-based guideline.      The specific aims of the study are:      Aim 1: Develop, implement, and integrate the asthma guideline in the ED information system     infrastructure.      Aim 2: Evaluate the effect of the asthma detection system combined with the computerized     guideline versus the asthma detection system combined with the paper-based guideline.   "
245178|NCT01070160|"     The investigators aim is to conduct a prospective un-blinded pilot study of premenopausal     women diagnosed with Polycystic Ovarian Syndrome (PCOS), defined using criteria developed at     the 1990 NICHD conference on PCOS, undergoing treatment for ovulation induction with     Metformin. We propose that improving insulin sensitivity with use of Metformin in women     diagnosed with PCOS has facilitatory influences on the uterine endometrium.   "
245261|NCT01059799|"     This trial is conducted in Asia and Japan. The aim of this trial is to compare insulin     degludec (NN1250) with insulin glargine both combined with oral antidiabetic drugs (OADs) in     subjects with type 2 diabetes never treated with insulin.   "
245181|NCT01070199|"     Energy-yielding fluids induce weaker appetitive and compensatory dietary responses than     energy-matched semi-solids or solids. This is problematic because the high and increasing     contribution of energy from beverages in the diet may enhance positive energy balance and     weight gain. The prevailing view of the overweight/obesity problem is that it stems from a     small, sustained positive energy balance. It follows then that only small changes, perhaps     manipulations in the rheological characteristics of the diet, will be required to correct the     problem. Certain populations that are more prone to weight gain may benefit from such     manipulations. Obese individuals have a higher beverage intake and experience greater weight     loss with reductions in beverage intake. Further, there is evidence that obese individuals     consume more energy after a liquid pre-load than their lean counterparts, yet there is no     difference in energy intake after a solid load. In contrast, habitual exercisers have been     shown to have an increased accuracy of short-term regulation of food intake at meals     following liquid preloads. A better understanding of the mechanisms by which beverages and     energy-matched solid food forms elicit differential appetitive and dietary responses in these     populations needed. This research will attempt to identify the influence of physical fitness     and body fat on the ability to compensate for the energy content of solid and liquid preloads     by reduction in energy intake at a subsequent ad libitum meal (i.e., acute compensation) and     over the course of the day (i.e., short-term compensation). Furthermore, this study will     examine the cognitive contribution to differential responses to energy-matched beverage and     solid food forms and the effects of mastication on appetite, GI transit, glycemic response,     and selected endocrine responses.   "
245182|NCT01070212|"     One obvious property difference between energy-yielding beverages and solid foods is the oral     mechanical processing required to prepare the two food forms for swallowing. Considerable     human data are consistent with a contribution of mechanical stimulation to appetite     suppression. However, no study has isolated this property and assessed its influence on     ingestive behavior in humans. This is the aim of the present study. The null hypothesis is     that food rheology will have no effect on these indices. The alternate hypothesis is that     increased mechanical stimulation will result in stronger satiation/satiety and reduced energy     intake. Further, it is hypothesized that the effects of mastication will be less evident in     obese compared to lean individuals.   "
245211|NCT01059149|"     The aim of the study is to determine if 2-week repetitive transcranial magnetic stimulation     at the subacute phase of stroke (between day 7 and day 14) improves significantly arm     motility at 3 months with remaining effect at one year, without significant adverse effect.   "
245187|NCT01070277|"     Study hypotheses is that Antiparasitic therapy in patients with chronic diarrhea after travel     to a developing country, with a negative stool findings, will be significantly effective in     eliminating diarrhea and other gastro-intestinal complaints compared to similar patients     receiving placebo.   "
245188|NCT01070290|"     This will be a multi-center, open-label randomized phase 2 study designed to evaluate the     progression free survival (PFS) of patients with advanced gastric cancer following treatment     with either ARQ 197 or one of three standard regimens (investigator's choice). Patients with     unresectable (locally advanced or metastatic) gastric carcinoma who have progressive     neoplastic disease following treatment with a prior regimen consisting of at least two of the     drugs 5-FU, cisplatin and docetaxel. The study will also evaluate other efficacy and safety     parameters including overall response rate, overall survival and adverse events in the two     treatment arms.   "
245189|NCT01070303|"     The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term     maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate     the long-term safety of adalimumab when administered to participants with Crohn's disease.   "
245190|NCT01070316|"     The goal of this study is to learn if the study drug RAD001 can reduced the number of     epileptic seizures, and can be taken safety by people who have epilepsy associated with     Tuberous Sclerosis Complex.   "
245191|NCT01070329|"     The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for     8 weeks to patients diagnosed with major depressive disorder, who also report associated     painful physical symptoms, is better than placebo when treating depression and its associated     painful symptoms.   "
245192|NCT01058889|"     The purpose of the study is to show if telemonitoring and automated feedback regarding     glucose management, physical activity, blood pressure, and body weight improves treatment of     patients with insulin dependent Type 2 Diabetes mellitus.   "
245193|NCT01058902|"     Lung cancer is the most common cancer in the western world. Only 10 to 15 % of patients     diagnosed with lung cancer are suitable for potentially curative surgical treatment. Despite     surgery, recurrence of lung cancer still occurs. Aspirin potentially may help increase     survival by altering the biochemistry of any potential remaining lung cancer cells. Most lung     cancer occurs in smokers. Smokers are at increased risk of heart attacks and strokes. Aspirin     has beneficial effects on the heart and brain, potentially reducing the incidence of heart     attacks and strokes.   "
245194|NCT01058915|"     In patients with ST-segment elevation acute myocardial infarction (STEMI) increased     LDL-cholesterol reduction (rosuvastatin 40 mg) will provide incremental plaque stabilization     (changes in plaque composition) and plaque regression over 12 months beyond the benefit of     moderate LDL-cholesterol reduction (rosuvastatin 5 mg) (assessed by IVUS and VH).   "
245195|NCT01058928|"     Fluid leak around the cuff is minimized when the endotracheal tube size is small relative to     the size of the trachea. In the current study, the investigators assess the influence of     different HVLP endotracheal tube size on fluid leakage around the cuff in a benchtop model     and in anesthetized patients.   "
245196|NCT01058941|"     The purpose of this study was to see if taking lipoic acid plus omega-3 fatty acids     (omega-3s) can slow the Alzheimer's disease (AD) process. To see if the treatment can slow     the AD process, the investigators looked at changes in memory and changes in a person's daily     activities over 18 months.   "
245197|NCT01058967|"     The purpose of this study is to investigate the use of ultrasound by aeromedical prehospital     providers.   "
245262|NCT01059812|"     This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin     degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with     type 2 diabetes not optimally controlled on once or twice daily insulin with or without     metformin.   "
245198|NCT01058980|"     Atrial fibrillation (AF) is the most common heart rhythm disorder, impairs quality of life     and increases stroke risk and mortality. Despite advances in medical treatment, AF remains     uncontrolled in many patients. In many patients, AF is initiated by abnormal electrical     impulses from the pulmonary veins. A catheter ablation procedure called pulmonary vein     isolation (PVI) has therefore been developed, using heat to isolate the PV foci from the     heart. PVI is very effective, but must be repeated in up to 50% of cases because the foci     isolation is not permanent after initial PVI. The intravenous administration of a drug called     adenosine during the PVI procedure can unmask residual conduction that would otherwise remain     unnoticed, so-called dormant conduction. In our experience, additional ablation guided by     adenosine reduces AF recurrence and the need for a repeat PVI procedure. However, the     adenosine-guided approach has not yet been proven as standard therapy. The present study, to     be conducted at 15 clinical centres in Canada, Europe and Australia is therefore intended to     evaluate the efficacy of adenosine-guided ablation to prevent AF recurrence. Five hundred     twenty-six patients will be included in the study, which should be completed within 2 years.     In all patients, the presence of dormant conduction will be tested with adenosine during PVI.     If dormant conduction is observed, additional ablation will be performed in half of these     patients selected randomly. If there is no dormant conduction, randomly selected patients     will be followed in a registry. If the adenosine-guided approach is demonstrated to improve     the success rate of PVI procedures, it should become the standard approach for a permanent     cure of AF, and therefore benefit patients by reducing arrhythmia recurrence,     hospitalizations and the need for repeat interventions.   "
245199|NCT01058993|"     This is an initial study to determine if CXCR4 inhibitor AMD 3100 or plerixafor may be a     potential treatment for neutropenia due to CXCR4 mutations, the myelokathexis or WHIM (warts,     hypogammaglobulinemia, immunodeficiency and myelokathexis) syndrome. This is the initial     study of this concept and will involve up to 6 patients to receive increasing doses of     plerixafor administered subcutaneously or on an alternate day basis. It is unknown if these     patients will be highly sensitive to a blockade of CXCR4 activity and release more white     blood cells than normal volunteers or cancer patients given the same dose of this drug.     Therefore doses will begin at a level 12 fold less than currently used to mobilize stem cells     and will be increased stepwise to achieve an acceptable circulating level of neutrophils.   "
245200|NCT01059006|"     The aim of this study is to analyze the results of PresbyLASIK performed using the     wavefront-optimized LASIK for the treatment of presbyopia on low hyperopic and low myopic     patients with astigmatism. Visual performance will be assessed using clinical outcome     measures of the following: refraction, near, intermediate and distance visual acuity,     stereoacuity and contrast sensitivity. Questionnaires will also be used to evaluate how the     patient's vision is before and after surgery.   "
245201|NCT01059019|"     The purpose of this study is to demonstrate that omega-3 supplement can be use as an adjunct     therapy for PRK patients. The investigators believe that omega-3 supplement will reduce the     size of persistent epithelial defects (PEDS) and eventually hasten the corneal     reepithelialization after PRK surgery. If the outcome of this study proves to be effective,     then PRK would be a more attractive option to those seeking refractive treatment.   "
245212|NCT01059162|"     The aim of the study is to evaluate the safety and effectiveness of the IOPtiMate (OT-135P)     in Laser Assisted Non-Penetrating Glaucoma surgery in Open-Angle and Pseudoexfoliative     Glaucoma patients.   "
245202|NCT01059032|"     Through the rapid growth of multislice Computer Tomography (CT) imaging, radiation protection     has become a major issue in the radiological community. Optimizing CT scanning is a key task     when keeping the radiation doses as low as reasonable achievable (the ALARA principle). Post     processing filters can improve and restore grainy and noisy low dose CT images by enhancing     structure and reducing image noise. In our study of 10 patients, the investigators perform a     preliminary evaluation of a novel post processing filter, which does picture element     correlations in all three spatial dimensions. By comparing normal dose pictures with     unprocessed low-dose pictures and pictures processed with two dimentional (2D) and three     dimentional (3D) filters,the investigators will be able to assess the possible clinical value     of the 3D filter. This project is collaboration between Buskerud Hospital (BU), Buskerud     University College, Norwegian Radiation Protection Authority (NRPA) and Center for Medical     Image Science and Visualization (CMIV). The project is part of the PhD of Lars Borgen.   "
245203|NCT01059045|"     Prospective controlled study evaluating cryocontact therapy of infantile hemangiomas of     preterm infants      Principal investigator: Rangmar Goelz, MD Coworkers: M Möhrle, M Moll, HM Häfner, W     Schippert, C Meisner, M Röcken, CF Poets      Background Despite their frequent occurrence, there is no established therapeutic procedure     for localized infantile hemangioma in preterm infants. A PubMed search with the key words     hemangioma, controlled study, infant or childhood revealed five studies (1-5), none of them     included preterm infants, even though low birth weight and prematurity have been described as     the most significant risk factors      Aim:      To evaluate cryocontact therapy of infantile hemangioma (IH) of 1 - 10 mm diameter in preterm     infants <=34 weeks of gestational age (GA) using a liquid nitrogen cooled metal at the     Department of Neonatology at the Tuebingen University Hospital.      Method:      In a prospective controlled study, preterm infants <= 34 weeks GA with at least 2 IH should     be randomized to have one treated with cryocontact therapy using a liquid nitrogen cooled     metal (-196°C), while the other one is left untreated. Primary endpoint is an intact skin at     the site of the hemangioma at 1 year corrected age . The study starts at August 1st, 2004.     Cryocontact is done by 3 trained dermatologist (MM, HMH, WS), outcome documentation,     including photodocumentation, by 2 neonatologist (RG, MoMo).      Statistical Analysis: A sample size of 25 intrapersonal pairs of treated and untreated IH is     needed to show a significant difference with alpha=0.05 and beta=0.9 between treated IH and     controls, assuming that 5% of the treated IH and 40% of the controls have an unsuccessful     primary outcome. Documentation will be made on standardized forms and the data will be     transferred to Excel. Biometric calculations will be handled with SAS 9.1.3. for Windows     using Fisher´s Exact Test for difference in proportions.      Ethics:      The study is approved by the Ethics Committee of Tuebingen University Hospital; all parents     must give written informed consent.   "
245204|NCT01059058|"     The purpose of this study is to learn more about the management of white spot lesions that     occur after orthodontic treatment. White spot lesions generally improve slightly with time.     To date, there is no proven method to help white spot lesions improve faster. Two treatments,     called MI Paste Plus and fluoride varnish, have shown some potential benefits in a laboratory     setting but have not undergone testing in a clinical setting. Approximately 240 subjects are     to be enrolled in this study. The study will take place in approximately 30 dental and     orthodontic offices across Idaho, Montana, Oregon, Utah, and Washington as part of Northwest     PRECEDENT, a five-state research network that was created to study the practical issues     facing dentists/orthodontists and their patients, and to provide information that will     improve the quality of oral health care as a whole. Researchers at the University of     Washington and Oregon Health & Science University share management and oversight of the     network and research projects.   "
245263|NCT01059825|"     MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational     drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus.     Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment     with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.   "
245205|NCT01059071|"     The purpose of this research study is to evaluate a new investigational drug to treat     neuroblastoma. This study drug is called DFMO. The objectives of this study will be to     monitor for safety and to find a maximum tolerated dose in this population. A secondary     objective will be to look at efficacy of DFMO.      The safety of the proposed dosing regimen in this trial will be tested by an on-going     risk/benefit assessment during the study. A patient benefiting from treatment, not     progressing on therapy, and in the absence of any safety issues associated with DFMO and/or     etoposide may continue on treatment with the expectation that there will be an overall     clinical benefit.      The procedures involved in this study include Medical history, Physical exam, Vital signs     (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the     tumor(s), MIBG scans, and Bone marrow aspirations. All of these tests and procedures are     considered standard of care for this population. Drug administration is also part of this     protocol, including an investigational new drug called DFMO, and later combined with an     already approved drug, etoposide.      The proposed dosing regimen is an oral dose of DFMO two times a day for each day while on     study. There will be 5 cycles. Each cycle will be 21 days in length. The first cycle will be     DFMO alone. In the second cycle etoposide will be added in and will be given orally once a     day for the first 14 days of each cycle (cycles 2-5).   "
245206|NCT01059084|"     The purpose of this study is to look at the effect of daily herpes medication, valacyclovir,     on HIV levels in the blood in persons who are HIV positive and do not have oral or genital     herpes.   "
245207|NCT01059097|"     The independent impact of surgeon volume on outcome of patients undergoing     pancreaticoduodenectomy in a high-volume Institution was assessed. A significant reduction of     pancreatic fistula rate was found in the high-volume surgeon group in comparison with     low-volume surgeon group. However, no difference between groups was found in mortality, major     complications, and hospital stay.   "
245208|NCT01059110|"     The principal objective of the study is to compare 5 usual strategies in the management of     plantar warts which did not cure after 5 weeks of a salicylate ointment given just prior the     trial. The trial will include immunocompetent patients coming from the community and should     help the office-based dermatologists and hospital in the decision-making therapeutic process.   "
245209|NCT01059123|"     The propose of this study is to determine whether a 6-day duration of oral amoxicillin     treatment of erysipelas is non-inferior to a 14-day standard duration intravenous then oral     amoxicillin regimen. This trial will be open but evaluation will be perform by a blind     evaluator.   "
245210|NCT01059136|"     Study hypothesis : An early blockade of aldosterone receptors initiated at the first medical     contact after acute myocardial infarction may reduce major cardiovascular events within 6     months after the occurrence of the myocardial infarction.      Primary efficacy criterion : The 6 month rate of the composite of death, resuscitated cardiac     arrest, potentially lethal ventricular arrhythmia, indication for implantation of an     implantable cardioversion device, occurrence or aggravation of heart failure.      Primary objective: To demonstrate the superiority of aldosterone blockade initiated as soon     as possible within 72 hours after the onset of acute myocardial infarction on top of standard     therapy, compared to standard therapy alone, with or without reperfusion therapy.      Study design : Prospective, multi-centre randomised, open labeled with 2 parallel study arms.   "
245213|NCT01059175|"     Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF)     refractory to optimal medical management, in presence of a depressed left ventricular (LV)     ejection fraction and a wide QRS complex. It is mainly limited by a high proportion of     non-responders. Attempts have been made, in small studies, to increase the number of     stimulation sites in order to optimize the resynchronization therapy. V3 is a planned     multicenter, randomized trial whose objective is to evaluate the clinical benefit conferred     by the addition of a second endocardial or epicardial LV lead in non-responders after at     least 6 months of standard biventricular stimulation.      The V3 trial will examine the clinical benefit conferred by the addition of a second LV lead     in non-responders compared to standard CRT.   "
245214|NCT01059188|"     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy     x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of     radiation directly to the tumor may kill more tumor cells and cause less damage to normal     tissue. Giving these treatments before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying the side effects of giving cetuximab together with     cisplatin and docetaxel before radiation therapy and cetuximab followed by surgery and to see     how well it works in treating patients with stage IIIB non-small cell lung cancer that can be     removed by surgery.   "
245215|NCT01059201|"     Background:        -  Research into the genetic causes of autism spectrum disorder (ASD) involves studies of          the DNA of children with autism. New DNA sequencing technology allows researchers to          study specific genes in search of genetic changes that may cause or contribute to ASD.          Individuals who donated DNA to the Autism Genetic Resource Exchange may benefit from          further study of their DNA samples with more advanced DNA sequencing technology.        -  The role of cholesterol in individuals with ASD is currently under investigation.          Research has suggested that abnormal cholesterol levels in children with autism may be          related to genetic mutations or changes in how cholesterol is regulated in the body.      Objectives:      - To study existing blood samples of children with autism spectrum disorders to evaluate the     relationship between genetic traits and cholesterol function.      Eligibility:      - Children with ASD who donated blood samples to the Autism Genetic Resource Exchange.      Design:      - Parents/guardians of minor children with ASD will provide consent for further research to     be performed on existing DNA samples in the Autism Genetic Research Exchange databank.     Information from this research may be provided to the consenting parents/guardians on a case     by case basis, as directed by the researchers.   "
245425|NCT01072331|"     The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in     patients with type 2 Diabetes for 4 weeks administration.   "
245216|NCT01059214|"     Background:        -  INFUSE AMI is an ongoing clinical trial examining how patients with heart attacks are          treated. The study's aim is to help determine the best way to treat patients with          specific kinds of heart attacks caused by blood clots.        -  To evaluate the effect of the heart attack on the heart tissue and function,          participants in the INFUSE-AMI study will have magnetic resonance imaging (MRI) scans of          the heart at specific times after their heart attack.      Objectives:      - To perform cardiac MRI scans on patients who are participating in the INFUSE-AMI study.      Eligibility:      - Individuals at least 18 years of age who are enrolled in the INFUSE-AMI study.      Design:        -  Participants will have an MRI scan of the heart about 5 days and between 23 and 44 days          after their heart attack. The MRI scan at day 5 is optional.        -  Participants will provide a blood sample prior to the MRI scan.        -  During the scan, participants will be given a contrast drug to show the blood flow to          and within the heart. An electrocardiogram will be used to monitor the heart during the          procedure.        -  No other treatment will be provided in this protocol.   "
245217|NCT01059227|"     Background:      - Research has shown that the hormone corticotropin-releasing hormone (CRH) is involved in     stress and anxiety, and that drugs that block the effect of CRH in the body can reduce     anxiety. GSK561679 is an experimental drug that attempts to reduce anxiety by blocking the     effect of CRH. Researchers are interested in comparing GSK561679 with other treatments for     anxiety.      Objectives:      - To determine the effectiveness of GSK561679 compared with placebo and alprazolam (Xanax),     as a possible treatment for fear and anxiety.      Eligibility:      - Healthy female volunteers between 21 and 50 years of age.      Design:        -  This study will involve one screening visit, four testing visits, and one follow-up          visit over a period of 8-9 weeks. The testing sessions will be between 6-11 days apart.        -  Participants must follow these dietary restrictions to participate in the study.        -  No nicotine, alcohol, or caffeine (including chocolate and soft drinks) for 24 hours          before the start of the study.        -  No nicotine in the past 6 months, and no nicotine until the final blood sample is          collected at the follow-up visit.        -  No alcohol or caffeine for 24 hours before a testing visit or for 72 hours after each          visit.        -  No grapefruit or grapefruit products from 14 days before the first dose of study          medication until collection of the final blood sample.        -  Participants will receive a dose of GSK561679, alprazolam, or placebo 3 hours before the          testing, and will take an additional pill 1 hour before the testing.        -  During the tests, participants will receive brief electric shocks and hear sudden loud          noises. The noises and shocks will be given over a period of approximately 40 minutes          per session.        -  Skin conduction, heart rate, and blinking will be monitored throughout the tests, and          participants will be asked about anxiety levels and will be tested on mood, memory, and          concentration. Blood and saliva samples will also be taken during these sessions.        -  Participants will stay in the clinical center for 1 to 2 hours after the study testing          to ensure that the sedation has worn off. Participants will not be allowed to drive home          or take public transportation alone after study visits, so alternative transportation          must be arranged.   "
245231|NCT01059409|"     Total or subtotal meniscectomies in young patients are currently responsible of pain and     limitation of activities. There isn't any other treatment than meniscal replacement. But     there is no randomized clinical trial on meniscal allograft to validate the efficiency of     this treatment.   "
245232|NCT01059422|"     The study will investigate whether combination antiretroviral therapy of raltegravir and     3TC/ABC is effective and safe to use in tuberculosis (TB)/HIV co-infected adults receiving     rifabutin-containing, first-line antituberculous treatment.      Hypothesis:Combination antiretroviral therapy of raltegravir and 3TC/ABC and is effective and     safe to use in tuberculosis (TB)/HIV co-infected adults receiving rifabutin-based first-line     antituberculous treatment.   "
245233|NCT01059435|"     The primary objective of this study is to assess the safety and tolerability of AMG 785     following a single dose subcutaneous (SC) or intravenous (IV) administration in healthy men     and postmenopausal women.   "
245234|NCT01059448|"     This is an extension study for subjects who participated in Protocol 20090061 (NCT00950989).     All subjects in this study will receive a 210mg injection of AMG827 for treatment for their     Rheumatoid Arthritis for up to 5 years.   "
245218|NCT01059240|"     Background:        -  Spinal muscular atrophy (SMA) is a degenerative and incurable neuromuscular disorder          that is caused by mutations in the survival motor neuron gene, SMN1, found on chromosome          5. It is the leading inherited cause of infant mortality. SMA carriers (those who have          the genetic mutation but do not have the disease) are often unaware of their status          until they are tested.        -  Researchers have been studying the prevalence of SMA carriers in the general population,          but most of the information collected has come from populations within the United          States, Europe, and Asia. Very few studies have been performed in Africa. Furthermore,          this information does not provide much information regarding carrier frequency based on          ethnic background and ancestry. To address this problem, researchers are interested in          studying the prevalence of the SMA genetic mutation in the sub-Saharan nation of Mali.      Objectives:      - To collect blood samples for use in studying genetic data related to spinal muscular     atrophy.      Eligibility:        -  Healthy volunteers who are at least 18 years of age.        -  Volunteers will be of Malian ancestry and nationality.      Study Location:      -<TAB>Bamako, Mali, West Africa      Design:        -  The study will first collect blood samples from a small group of volunteers to run          initial SMA carrier testing and resolve any technical difficulties before continuing          with the study.        -  Participants will complete questionnaires about their personal and family medical          history, including questions about illnesses, stillborns, and miscarriages, and then          will provide blood samples for genetic research and testing.   "
245219|NCT01059253|"     Elderly individuals are often at increased risks for falls. The AdvanStep is an interactive     training exercise and balance device. The use of the AdvanStep will bring about a measurable     improvement in the individuals balance in standardized measures.   "
245220|NCT01059266|"     This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses     will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks)     compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).      The primary parameter will be the proportion of patients who experience systemic reactions >     grade I within 24 hours after injection or who need more than 2 additional injections during     the up-dosing phase until the maintenance dose has been reached.      It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as     using the conventional regimen.   "
245264|NCT01059838|"     The purpose of this study is to determine whether speech recognition in noise can be improved     by the addition of a special listening program to the sound processor. Thus we propose to     assess speech perception in noise for pediatric cochlear implant patients using both their     everyday listening program as well an ASC program.   "
245426|NCT01072344|"     Prior research has shown that chamomile may be an effective, short-term anti-anxiety     treatment. This study will examine the initial and long-term benefits of chamomile extract     therapy for the prevention of recurrent anxiety disorder.   "
245221|NCT01059279|"     There now causation between Heat Intolerance and FMF that were showed in studies till now. We     suggest that the prevalence of Heat Intolerance in the group of the FMF patients will be     significantly higher than in the group of healthy individuals, that participated in the study     of Heller Institute of Medical Research. The aim of the study is verification of causation     between these pathologies. The information obtained by the study may allow us to determine     the sequence of events associated with FMF attack development, and perhaps take us one step     further in the understanding of the pathogenesis of the disease.      15 FMF patients with double mutations MEFV, mail sex, from the age from 18 to 30 without     attacks during not less than 2 month will participate in the study. To identify an     individuals susceptibility to exercise heat test, a Heat Tolerance Test (HTT) will perform,     according to HTT Protocol of Heller Institute of Medical Research.   "
245222|NCT01059292|"     TIPE2, a negative regulator of innate and adaptive immunity that maintains immune     homeostasis. The investigators want to know whether TIPE2 is a risk factor for graft loss and     gives rise to the immune dysfunction in renal transplant patients.   "
245223|NCT01059305|"     The goal of this clinical research study is to learn if Tarceva ® (erlotinib) when taken     before and after radiation and/or surgery can help to control aggressive cutaneous squamous     cell carcinoma. The safety of the drug will also be studied.   "
245224|NCT01059318|"     This is an exploratory study. The purpose of the study is to determine whether escalating     doses of RAD001 (everolimus) is safe and effective in patients with Lymphangioleiomyomatosis   "
245225|NCT01059331|"     The aim of the study is to investigate if perioperative administration of pregabalin vil     reduce postoperative pain and the postoperative need for intravenous opioids compared with     todays standard treatment which consist of paracetamol, corticoids and ketobemidone.      In addition potential sideeffects as sedation and effect on cognitive function will be     recorded.   "
245226|NCT01059344|"     The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg     tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to     placebo in subjects with active ulcerative colitis (UC).   "
245227|NCT01059357|"     The purpose of this study is to conduct a pilot single-arm to assess transoral robotic     surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci     Robotic Surgical System.   "
245228|NCT01059370|"     Autonomic dysreflexia in high spinal cord-injured can be initiated by a full bladder or     bowel, or when trying to empty either. This randomised study aims at evaluating whether     irrigation procedure or digital stimulation or evacuation of the rectum is less provocative     of autonomic dysreflexia. Participants have their bowels emptied on different days, in the     morning fasting. Bladder filling with sterile saline water is evaluated on a third day as a     control.   "
245229|NCT01059383|"     The study is designed to assess the effect and safety of oral administration of VECAM 40/300     administered at bedtime compared to Esomeprazole 20 mg administered 30-60 minutes before     dinner, for control of nighttime and daytime HB and other 24 hour GERD symptoms.      The rational for the study is based on the contention that VECAM exhibits potent inhibition     of acid secretion and because of its mechanism of action, it can be administered at bedtime     without food. Such timing of drug dosing will allow effective inhibition of nighttime acid     secretion. Because of its mechanism of action, VECAM exhibits improved 24-hour inhibition of     acid secretion and hence, its bedtime administration will not compromise its effect during     the daytime. This improved control of acid secretion will predictably result in better     control of nighttime as well as daytime heartburn (HB) symptoms.   "
245230|NCT01059396|"     This is a multicenter, randomized, double-blind, placebo-controlled study on the     effectiveness of treatment with beta-blockers to prevent decompensation of cirrhosis with     portal hypertension.   "
245235|NCT01059461|"     The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy     will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic     encephalopathy after hospital discharge.   "
245236|NCT01059474|"     DMPS is a metal chelator which is approved for use in Europe. While not an FDA-approved drug     in the US, it is easily obtained and administered by alternative health practitioners to     their patients. A formulation called 'TD DMPS' (transdermal DMPS) is in use, despite the fact     there is no published literature to support that the agent is absorbed transdermally. The     investigators hypothesis is that DMPS is not absorbed through the skin. The investigators     plan to apply TD DMPS to healthy volunteers and then test serum for presence of DMPS. In     addition the investigators will measure urinary mercury concentrations pre and post DMPS     application.   "
245237|NCT01059487|"     At a time when there is so much focus in the United States on reducing the cost of health     care delivery while maximizing the effectiveness of health care performance, Traditional     Chinese Medicine (acupuncture, herbal treatment, and accessory techniques) offers decision     makers a tantalizing option. Traditional Chinese Medicine differs from its biomedical     counterpart in that it is highly portable, inexpensive to administer, relies on a     conversational diagnostic inquiry system to arrive at differential diagnosis for its     patients, and has very few reported side effects associated with treatment. The World Health     Organization cites acupuncture has a proven and effective treatment for 28 diseases/disorders     including stroke, pain management issues and rheumatoid arthritis; the WHO lists another over     65 diseases for which the therapeutic effect of acupuncture has been shown but for which     further proof is needed including alcohol dependence, cancer pain and diabetes mellitus. With     the completion of this pragmatic clinical trial and introduction of the Constant Care method     of health care delivery to underserved communities on Chicago's south side, the investigators     can both utilize an effective plan of health care delivery, advance the research needed to     effectively utilize Traditional Chinese Medicine as a low cost therapeutic option in this     country, and successfully treat disenfranchised populations that have been traditionally     overlooked and that deserve a better health and wellness care future.   "
245265|NCT01059851|"     This study will investigate whether the plasma concentration-time profile and     pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function     are similar to those observed in healthy participants; and will evaluate the safety and     tolerability of suvorexant both in participants with impaired renal function and in healthy     participants.   "
245238|NCT01059500|"     Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk     Emergency Department(ED) patients can increase exposure of nondiseased patients to radiation,     intravenous contrast and anticoagulation. This project addresses question of whether     quantitative Pre-Test Probability(PTP) assessed from two validated web-based computer     algorithms (the project webtool), can improve the diagnostic evaluation of adult patients     with charted evidence of chest pain and dyspnea. After a validation phase, the main study     will randomize patients to either the Standard care group or the Intervention group, which     will receive the output of the ACS and PE webtool that includes the PTP estimates of ACS and     PE and one of three recommendations regarding next steps: 1. No further testing, 2. Exclusion     with a biomarker protocol, or 3. Immediate imaging +/- empiric anticoagulation.   "
245239|NCT01059513|"     This is an observational study in which a questionnaire is used to obtain quality of life     data after patients undergo a hypo-fractionated course of stereotactic body radiotherapy     (SBRT) for the treatment of their prostate cancer. The SBRT itself is considered standard of     care for these patients and as such, is not an official component of the study.   "
245240|NCT01059526|"     The objective of this study is to evaluate the formation of antibodies, the occurence of     allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients     treated with KALBITOR (ecallantide).   "
245241|NCT01059539|"     The objective of this study is to evaluate the long-term safety, tolerability, and     pharmacokinetics of cariprazine in patients with bipolar I disorder.   "
245242|NCT01059552|"     The purpose of this study is to determine the maximum tolerated dose of the combination of     vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage     IIIA/IIIB non-small cell lung cancer.   "
245243|NCT01059565|"     The purpose of this research study was to determine if an experimental drug called Aztreonam     for Inhalation Solution (AZLI) was safe and effective to treat Burkholderia lung infections     in patients with cystic fibrosis (CF).      Spirometry was used to assess pulmonary function, and the revised Cystic Fibrosis     Questionnaire (CFQ-R) was used to assess quality of life. The CFQ-R is a validated,     patient-reported outcome tool used to measure health-related quality of life for children and     adults with CF.      The study consisted of a 24-week randomized phase, and a 24-week open-label phase. Primary     and secondary efficacy analyses were conducted for the 24-week randomized phase only. Safety     data were collected for both the randomized and open-label phases.   "
245244|NCT01059578|"     This is the first study in humans with GSK206136 to evaluate what effects: good or bad, the     drug has on human health (safety and tolerability) and the amount of drug which gets into the     bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to     investigate the penetration of the drug in the human brain by using PET (Positron Emission     Tomography) imaging technology   "
245245|NCT01059591|"     This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the     drug has on human health (safety and tolerability) and the amount of drug which gets into the     bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to     investigate the penetration of the drug in the human brain by using PET (Positron Emission     Tomography) imaging technology   "
245246|NCT01059604|"     Anti-migraine drugs, including triptans, are not indicated for use in pregnancy. However, the     peak prevalence of migraine is in women of childbearing age. This, coupled with the sporadic     nature of migraine attacks and high rates of unplanned pregnancies, makes unintentional     exposure to anti-migraine medications during pregnancy likely. Prior to an anti-migraine     medication being marketed there are few data available on drug safety in pregnancy: data from     animal models may not translate directly to humans and pregnant women are routinely excluded     from clinical trials. The Sumatriptan Pregnancy Registry was established by GlaxoSmithKline     (GSK) in 1996 to monitor the safety of sumatriptan during pregnancy. It was combined with the     Naratriptan Pregnancy Registry in 2001 and data collection on the sumatriptan-naproxen     combination (Treximet) began in 2008.   "
245247|NCT01059617|"     This study is designed to characterize the safety and immunogenicity of a' pandemic influenza     (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received     influenza vaccination.   "
245339|NCT01071187|"     The varenicline for alcohol dependence trial investigates the efficacy of varenicline versus     placebo for maintaining abstinence in the postacute treatment of alcohol dependent subjects.     The main study hypothesis is that subjects treated with varenicline have more abstinent days     during the study.   "
245248|NCT01059630|"     This open-label, multicenter, randomized Phase III study will investigate the efficacy,     safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined     with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy)     compared with bendamustine alone treatment in participants with rituximab-refractory indolent     Non-Hodgkin's lymphoma (iNHL).   "
245249|NCT01059643|"     The purpose of the study is to estimate the rate of response for patients with ovarian,     non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who     are administered LY2523355.   "
245250|NCT01059656|"     In relation to the activation of PDGF-mediated signalization due to the fusion gene     COL1A1-PDGFb in DFSP, imatinib (800mg/day) has shown activity in advanced DFSP and has became     the reference treatment option for these patients. Yet the activity observed does not allow     for a downstaging compatible with successful resection in a number of patients and does not     prevent subsequent tumour progression in case of residual tumour.Pazopanib in relation to 1)     its multi tyrosine kinase inhibiting activity (VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-α, PDGFR-β     and c-kit with IC50 values of 10, 30, 47, 71, 84, and 74 nM, respectively) involving in     particular PDGFR, and VEGFR which has been shown to be activated in DFSP, 2) its antitumour     activity in sarcomas patients, and 3) its acceptable safety profile, is a logical candidate     for therapeutic trials in DFSP both in patients not expected to derive a sufficient benefit     from imatinib and in patients failing imatinib mesylate. Moreover, using quantitative RT-PCR     and immunohistochemistry we have recently demonstrated high levels of VEGF and VEGFR2     expression in dermatofibrosarcoma.   "
245281|NCT01070394|"     The purpose of this study is to examine the effectiveness and length of effect of Vyvanse on     lessening Attention-Deficit/Hyperactivity Disorder symptoms in adults. The study will also     investigate the safety and tolerability of Vyvanse in adults with ADHD.   "
245251|NCT01059669|"     To develop a new standardized multimodal diagnostic approach to CP considering:      WP 1: Fat in faeces and functional testing; the combination of tests has to be easy to     practice, should take as little time as possible and discomfort for the patient has to be     minimized WP 2: Advanced ultrasonography and imaging modalities. The focus is on validating     standard parenchymal, contrast enhanced and functional ultrasound compared to a modern     imaging standard. (CT, EUS, MRI)      To evaluate the reliability and feasibility of these novel methods in healthy volunteers; AND      To compare findings in known severe CP patients and different stages of pancreatic     insufficiency in patients with CP.   "
245252|NCT01059682|"     This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect     of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker     profile and long-term safety profile of dalcetrapib in patients with coronary artery disease.     Atherosclerotic disease progression will be measured 1. Coronary Intravascular Ultrasound     (IVUS), Quantitative Coronary Angiography 2. Carotid B-Mode Ultrasound Intima Medial     Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have     coronary artery disease (CAD). Patients will be randomized to receive dalcetrapib 600 mg     orally once a day or placebo. The anticipated time on study treatment will be 24 months. The     target sample size is 800-1000 patients.   "
245253|NCT01059695|"     Analysis of all women treated for cervical cancer between 2000 and 2008 in Limburg, a     province in the south of the Netherlands. Patient characteristics, diagnosis, treatment     modalities, complications and survival will be analyzed by record review. Quality of life of     the living study population will be assessed using the EORTC QLQ-C30 and QOQ-CX24     questionnaire. Patients will be identified via registration data from the Integraal     Kankercentrum Limburg.   "
245254|NCT01059708|"     Carbon monoxide poisoning is common. Many adults with CO poisoning have long-term, even     permanent brain injury following poisoning. However, very little is known about the long-term     outcome of children with carbon monoxide (CO) poisoning. In this study we plan to perform     cognitive (thinking) and vestibular (balance) testing in children (ages 6 to 16)at 6 weeks     and 6 months following CO poisoning.      At the 6-week visit, if the child and parents agree, we will ask each child to provide a DNA     sample by one of three methods: mouthwash, spit collection, or swabbing the inside of the     child's cheek. Each child's DNA will be analyzed for genes that are known to affect outcome     following brain injury.   "
245255|NCT01059721|"     Soft tissue realignment of the tibial insertion of the patella tendon is a simple operative     technique for treating dislocation of the patella in childhood and adolescence. It is     performed in children with either recurrent dislocation or complicated primary dislocation in     cases with malalignment or maltracking of the patella and a lateralised tibial tuberosity. It     can be performed in patients with open epiphyses. We investigate long-term outcome after this     procedure.   "
245256|NCT01059734|"     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is looking at biomarker expression in bone marrow samples from     patients with acute myeloid leukemia.   "
245257|NCT01059747|"     Addiction has been regarded as one of the most serious health and social problems in Taiwan,     and heroin is currently considered to be the major substance of abuse. The most widely used     treatment to date is methadone replacement therapy. It is reported that to achieve a better     clinical response and to avoid possible side effects, the blood level of methadone should     remain in a certain level. However, the blood level of methadone is mediated by various     factors besides dosage. Genetic variability in genes that encodes enzymes affecting methadone     metabolism, target receptors of methadone, and drug-drug interaction by other medication     patients take will all affect blood level. Therefore, therapeutic drug monitoring (TDM) and     pharmacogenomic study is crucial for evaluating and predicting the clinical response, cause     of side effects or toxicity, as well as studies on drug-drug interactions.      This is a cross-sectional study in order to evaluate the relationship between methadone     plasma level and clinical response in patients under methadone maintenance therapy and to     identify optimal therapeutic thresholds. HPLC will be used to analyze methadone and its     metabolites. Our hypothesis is that methadone plasma levels in patients who are responsive to     methadone maintenance therapy are higher than level in non-responsive patients, and higher     plasma level leads to less severe withdrawal symptoms. We will also test if an optimal     minimal dosage exists among these patients. In the meanwhile, we will aim to test if     methadone level and clinical response is correlated with different genetic polymorphism.     Candidate genes that involve in pharmacokinetic and pharmacodynamic process of methadone     (e.g. CYP3A4, CYP3A5, CYP2B6, ABCB1, opioid mu receptor and kappa receptor) will be genotyped     for these analyses.      The results of this study will provide clinical information of methadone treatment and     pharmacogenomic data in Taiwanese for clinicians to achieve a better treatment outcome.   "
245258|NCT01059760|"     The purpose of this study is to evaluate the effect of fasting on physical changes associated     with cardiovascular disease.   "
245274|NCT01059981|"     The 'Analysis of Emergency Department Volumes during Natural Disasters' retrospective study     focuses on three specified populations including dialysis patients, trauma patients, and     patients poisoned by carbon monoxide. These three populations have one commonality -     hurricanes, ie. natural disasters, which is the exposure. Causal associations and significant     correlations will be explored in all three subgroups.   "
245259|NCT01059773|"     This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who     receive ustekinumab following an inadequate response to methotrexate therapy. The study will     provide information for doctors on how to manage the transfer from methotrexate to the     biologic agent ustekinumab. The study is designed to compare two methods of transferring     patients from methotrexate to ustekinumab. The two methods being compared are discontinuation     of methotrexate with immediate initiation of ustekinumab versus initiation of ustekinumab     with overlap and gradual dose reduction of methotrexate over 4 weeks.   "
245260|NCT01059786|"     Background:        -  Researchers are attempting to develop new treatments for hairy cell leukemia (HCL) that          has not responded well to or has recurred after standard HCL therapies. One nonstandard          treatment for HCL is rituximab, an antibody that binds to the cancer cells and helps the          immune system destroy them. By combining rituximab with other anti-cancer drugs,          researchers hope to determine whether the combined drugs are successful in treating HCL.        -  Pentostatin and bendamustine are two anti-cancer drugs that have been used to treat          different kinds of blood and immune system cancers. Bendamustine is approved to treat          other kinds of leukemia and lymphoma, but it has not been used to treat HCL. Pentostatin          has been used for more than 20 years to treat HCL, but it has not been combined with          rituximab in official clinical trials.      Objectives:        -  To determine whether rituximab with either pentostatin or bendamustine is a more          effective treatment for HCL than rituximab alone.        -  To determine whether pentostatin or bendamustine is a more effective treatment for HCL          when combined with rituximab.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with hairy cell leukemia that     has not responded well to or has relapsed after standard HCL therapies.      Design:        -  The study will last for four treatment cycles of 28 days each.        -  Prior to the study, participants will be screened with a full medical history and          physical exam, bone marrow biopsy (if one has not been performed in the last 6 months),          computed tomography (CT) or ultrasound scan, tumor measurements, and other tests as          required by the researchers. Participants will provide blood and urine samples at this          time as well.        -  Rituximab with bendamustine: Participants will receive rituximab on Days 1 and 15 of          each cycle and bendamustine on Days 1 and 2 of each cycle, for a total of four cycles.        -  Rituximab with pentostatin: Participants will receive rituximab on Days 1 and 15 of each          cycle and pentostatin on rituximab on Days 1 and 15 of each cycle, for a total of four          cycles.        -  Participants will have regular tests during the treatment cycles, including bone marrow          biopsies and CT or ultrasound scans. Participants will also provide regular blood and          urine samples to assess the results of treatment.   "
245266|NCT01059864|"     All patients will be in instructed to eat a therapeutic lifestyle diet and will receive     CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the     cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first     measure the effects of CP-690,550 on cholesterol levels and then the effects of adding     atorvastatin on those levels.   "
245267|NCT01059877|"     This study will employ a double-blind, placebo-controlled approach to assess the effect of     1072nm infrared (IR) phototherapy on the behavioral and cognitive symptoms associated with     early and mid-stage dementia.   "
245268|NCT01059890|"     The aim of the study is to explore the distribution of antibiotics in the brain after an     acute brain injury because brain infections treatment is still an health care problem.   "
245269|NCT01059903|"     The major aim of this study is to investigate and compare the drug amount delivered to the     body after sequential application of two Rotigotine patches of two different formulations   "
245270|NCT01059929|"     This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged     sedation (> 24 hours) in critically ill patients who require mechanical ventilation.   "
245271|NCT01059942|"     The aim of this project is to develop and validate a simple, flexible, reliable, real-time     observation tool to evaluate hand-off practices. The Hand-off CEX is a paper-based instrument     that can be used to evaluate either the sender or the receiver of hand-off communication.     This tool is based on a previously-validated, widely-used, real-time educational evaluation     tool (the Mini-CEX); published expert opinion; and our prior research . The investigators'     tool incorporates unique role-based anchors for both senders and receivers that refer to     verbal communication, professionalism and environment, hand-off domains informed by     preliminary work and expert opinion. The Hand-off CEX(Clinical Evaluation Exercise) will be     used by academic hospitalists and house-staff physicians to assess feasibility. We, the     investigators, will also assess the construct validity and inter-rater reliability of the     tool through the use of standardized, videotaped hand-off scenarios depicting various levels     of performance of a hand-off scenario.      We hypothesize that the Hand-off CEX will arm educators with an innovative, necessary, valid     and feasible method for training health professionals to conduct safe and effective     hand-offs. Finally, the Hand-off CEX will be a useful tool to assist hospitals in improving     patient safety.   "
245272|NCT01059955|"     This is an initial clinical trial evaluating whether different doses of iontophoresis for     delivery of dexamethasone phosphate can be tolerated by eyes of patients with non-infections,     non-necrotizing scleritis. A secondary goal is to get preliminary information about whether     the treatment is likely to be an effective treatment for scleritis. If the results are     favorable, further trials evaluating the treatment may be pursued.      Funding sources: FDA OOPD, Eyegate Pharmaceuticals, Inc.   "
245273|NCT01059968|"     This study examines the role of energy availability on menstrual function and bone mass in     female adolescent endurance athletes. Specific evaluations include dietary intake, exercise     energy expenditure, training schedules, menstrual function and bone density.   "
245406|NCT01072084|"     The purpose of this study is to evaluate the endoscopic diagnostic options of the     endomicroscopy in patients with food intolerance.   "
245275|NCT01059994|"     This is a pilot study funded by the National Institutes of Health. In this project, we will     investigate the potential effect of skeletal muscle nitric oxide (NO) production on muscle     strength and physical function in older individuals. We propose to test a new method that may     enable simultaneous determination of both vascular and skeletal muscle NO production for the     first time in humans. Further, we will determine whether augmentation of NO-mediated     responses, by administration of sildenafil citrate (Viagra), reduces fatigue and fatigability     in older individuals.   "
245276|NCT01060007|"     To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at     or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while     maintaining response rates comparable to what would be expected with radiotherapy and     concurrent chemotherapy.   "
245277|NCT01070342|"     Ambulatory Blood Pressure Monitoring (ABPM) potentially offers a superior way to screen     children for entry into antihypertensive trials, assuring that only those with true     hypertension are enrolled.10 In addition, ABPM offers a better method to measure response to     drug therapy.11-16 The ABPM device most commonly used in children (Spacelabs 90217 -     Issaquah, Washington) has not been independently validated for use in this population. In     1993, the British Hypertension Society (BHS) published a protocol for validating ABPM     devices, including guidance for validation studies in children.17 More recently, the Working     Group on Blood Pressure Monitoring of the European Society of Hypertension published     revisions to these guidelines, but did not include children in this update.18 Unfortunately,     the original BHS protocol suggests using a smaller group of children than the protocol     outlines for adults. Since BP in children is more variable than in adults, this guidance is     unlikely to be adequate for children. Hence, a large, stringent validation study needs to be     conducted in a cohort of children using the methods similar to those used to validate the     device in adults. Performance of the proposed validation study is needed to allow for the     incorporation of ABPM into clinical trial designs of anti-hypertensives in children which     will ultimately allow for more accurate identification of the hypertensive population and     determination of response to therapy along with allowing for assessment of the chronobiologic     profile of drug response over the dosing interval.9   "
245278|NCT01070355|"     Eicosapentaenoic acid (EPA) is a naturally occuring omega-3 polyunsaturated fatty acid found     in oily fish. EPA has anti-colorectal (bowel) cancer activity in experimental models. This     trial will test whether EPA reduces markers of tumour growth, and is safe and well     tolerated,in patients with colorectal cancer liver metastases awaiting surgery.   "
245279|NCT01070368|"     Nowadays, commercial wheat extract is widely accessible, and is used for skin prick test for     wheat allergy. However, commercial wheat extracted for skin prick test have less precise test     result compared to extract from omega-5 gliadin, which is one of the major allergen with     immediate wheat allergy.   "
245280|NCT01070381|"     The purpose of this study is to investigate the subjective and objective performance of two     daily disposable lenses for wearers with astigmatism.   "
245489|NCT01073163|"     The primary objective of this study is to assess the effect of treatment with bendamustine on     cardiac repolarization as reflected by the rate-corrected QT interval by the Fridericia     method (QTcF).   "
245282|NCT01070407|"     HCV001 is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine     against Hepatitis C virus (HCV). The vaccine is based on the sequential delivery, by     intramuscular route, of two different adenoviral vectors, of human and chimpanzee origin     respectively, bearing the same genetic information for HCV antigens (NS region).      The two recombinant vectors, called Ad6NSmut and AdCh3NSmut, are weakened and unable to     multiply within the body; they are designed to induce an immune response against HCV     proteins. Although Ad6NSmut and AdCh3NSmut have never been given to humans before this trial,     promising results have been obtained in non-human studies.      The HCV001 study is designed to explore different prime-boost regimes concerning dose, order     and interval of administration of Ad6NSmut and AdCh3NSmut.   "
245283|NCT01070420|"     The purpose of this study is to evaluate the safety and effectiveness of the peripheral IV     continuous infusion without the insertion of central venous vascular access method in the     achievement of steady-state maximal coronary hyperemia compared with the central IV     continuous infusion method.   "
245284|NCT01070433|"     The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment     of subjects with diabetic foot ulcers (DFUs).   "
245285|NCT01070446|"     Cystic fibrosis (CF) is the most common lethal, inherited disorder among Caucasians. Choline     is an essential vitamin and as a methyl donor is critically needed to support the normal     metabolism. Our previous studies have demonstrated that children with CF have depleted levels     of choline. The purpose of this study is to supply a choline supplement to children with CF     to see if their nutrition and methyl status can be improved.   "
245286|NCT01070459|"     This study aims to investigate the effect of aerobic exercise on the aerobic capacity, the     daily functioning, post-stroke fatigue , depression and cardiovascular risk factors in stroke     patients.   "
245287|NCT01070472|"     The purpose of this study is to determine whether a titrated solution of oral Misoprostol is     safe and effective at inducing labor at term, regardless of Bishop Score.   "
245288|NCT01070485|"     The purpose of the study is to investigate if multiple (up to four) intravenous injections of     Xofigo (Alpharadin) have any clinically relevant effect on bone markers in breast cancer     patients with bone dominant disease who have progressed on endocrine therapy and are no     longer considered suitable for endocrine therapy. In addition the safety of Xofigo     (Alpharadin) will be assessed.   "
245289|NCT01070498|"     The goal of this study is to determine whether Trichuris suis ova, a potential     immunomodulator, is safe in adults and children allergic to peanut or tree nuts.   "
245302|NCT01070667|"     The purpose of this study is to accurately investigate the efficacy of dronedarone in     maintaining sinus rhythm and decreasing AFB in patients with paroxysmal atrial fibrillation     as compared with placebo. This has never previously been performed using pacemaker Holter     monitoring which provides detailed information of atrial arrhythmia patterns the entire study     period. Additionally detailed patient symptom self assessment and questionnaires will be     collected. The study design will be double blinded crossover with each phase lasting 3     months.   "
245290|NCT01070511|"     Summary for Patients: This study, funded by the Muscular Dystrophy Association, is intended     to build on recent findings published in the journal Nature showing beneficial effects of     tadalafil (also known as Cialis) in mice with an animal version of Duchenne and Becker     muscular dystrophies. Only two doses of tadalafil improved muscle blood flow, allowing the     dystrophic mice to perform more exercise with less muscle injury. This new short-term     clinical trial will move the testing from animals to human patients with Becker muscular     dystrophy and examine the effects of acute tadalafil dosing on muscle blood flow during a     bout of exercise. Patients will take two doses of tadalafil prior to exercising. Then doctors     will measure whether muscles receive increased blood flow and therefore are better protected     during exercise.      Scientific Hypothesis: In patients with Becker muscular dystrophy (particularly those with     dystrophin gene mutations between exons 41-46), loss of sarcolemmal nitric oxide synthase     engenders functional muscle ischemia and thus muscle edema after an acute bout of exercise.     The investigators further hypothesize that PDE5A inhibition, which boosts nitric oxide-cGMP     signaling, constitutes an effective new countermeasure for these patients.   "
245291|NCT01070524|"     Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188     pMDI qd in adult patients with persistent asthma   "
245292|NCT01070537|"     The Bonfils intubation fiberscope (BF), a rigid medical device with a curved tip, is     exclusively used in anesthesiology for orotracheal intubation (OTI). The objective of the     study was to evaluate the feasibility and the tolerance of an intubation procedure realized     by means of the BF (BFI) in awake adult patients with predicted difficult intubation (PDI),     in the context of ENT cancer surgery.      The intubation is performed under local anesthesia (either nasal, oral, or     intercricothyroidal) and sedation using Remifentanyl (AIVOC) with spontaneous ventilation.     The primary endpoint is the rate of BFI meeting quality requirements: the procedure must be     both successful (≤ 2 attempts and duration < 180 sec) and well tolerated (Fahey score < 2).     The secondary endpoints include the difficulties met by the operator during the BFI and     patient's perception of the intubation procedure, evaluated in the recovery room and 7 days     after the intervention. Sample size is calculated using a one-stage Fleming design with     p0=80%, p1=95%, alpha=5% and 80% power, for a total of 32 evaluable patients.   "
245293|NCT01070550|"     This observational study will assess predictors of early on-treatment and sustained     virological response in treatment-naïve patients with chronic hepatitis C initiated on     treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during     the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target     sample size is <5000.   "
245294|NCT01070563|"     In France the diagnosis of brain death relies on electroencephalography (EEG) or cerebral     angiography. Concerning the latter a time of 6 hours is mandatory between the clinical     diagnosis and the realization of the cerebral computed tomography (CT) angiography.     Transcranial doppler (TCD) is not recommended in the french guidelines for the diagnosis of     brain death. In other countries, some flow patterns allow to confirm the diagnosis of brain     death. The hypothesis of our study is that TCD could shorten the time between the clinical     diagnosis of brain death and the realization of the CT angiography.   "
245295|NCT01070576|"     Objective: Primary objective is to study the arginine-NO metabolism during fracture healing     and dysfunctional fracture healing. Secondary objective: to investigate if differences or     decreased arginine and NO concentrations in bone healing form a prognostic marker for     non-union development Hypothesis: Early detection of disturbances in the Arginine and nitric     oxide metabolism during fracture healing are a good prognostic marker for non-union     development.      Study design: Prospective observational study. Study population: All acute fracture patients     (age >18 years), with a fracture of the tibia or femur attending the Department of General     Surgery, to investigate the Arginine -NO metabolism during normal fracture healing and     possible dysfunctional healing. In total 100 patients will be included during this study.      Main study parameters/endpoints:      Primary endpoints are arginine and Nitric Oxide levels in the plasma during normal and     dysfunctional fracture healing the bone in patients with and without non-union Secondary     endpoints are levels of Nitric Oxide citrulline, ornithine and other amino acids in bone and     in plasma Other parameters: baseline demography details will be obtained, including possible     confounders, such as bodyweight, smoking, alcohol abuse, which may interfere with the outcome     of this study.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The extent of the burden and risk associated with participation is expected to     be low during this study. In total, 7 blood samples will be taken during this study (45ml, in     total). During the primary (and possible secondary) surgical procedure, bone debris will be     taken. Bone debris is usually discarded but will be used for analysis in this study. There is     no extra surgical procedure necessary to obtain the bone debris.   "
245296|NCT01070589|"     The aim of the present study is to asses the effect of obesity on anaerobic exercise's growth     hormone (GH) response.   "
245297|NCT01070602|"     Intraoperative Floppy Iris Syndrome (IFIS) may occur during cataract surgeries in patients     treated with alpha 1 blockers. IFIS related to alpha 1 blocker Tamsulosin (used for prostate     hypertrophy) was reported in 50-90% of patients. IFIS during surgery make the surgery more     difficult and raise complication rate.      Using anterior corneal incisions was reported briefly in literature as a prophylactic means     but was not studied prospectively. we believe (according to our clinical experience) that     these anterior incisions do help to reduce the incidence and severity of IFIS signs and     complications rate during surgeries.   "
245298|NCT01070615|"     Objectives: Evaluation of the clinical long-term safety, tolerability, patient satisfaction,     pharmacokinetics and pattern of use of oral prucalopride tablets given in doses up to 4 mg     once daily to patients with chronic constipation   "
245299|NCT01070628|"     The purpose of this study is to confirm that the dose levels and dosing frequency utilising     the new Stalevo strengths would result into more stable levodopa plasma levels. Therefore, it     is anticipated that when lower dose of Stalevo is administered after the first higher dose of     Stalevo, this would result in equally high levodopa maximum concentration values (Cmax) after     each dose throughout the day compared to Cmax after the first dose.   "
245300|NCT01070641|"     Aim To compare Carvedilol with variceal band ligation in the prevention of first variceal     bleed.      End points of trial Primary: Variceal hemorrhage Secondary: Death      Study design      Randomised controlled clinical trial. Results analysed for the above end points on an     intention-to-treat basis.   "
245301|NCT01070654|"     Recruitment manoeuvres, consisting of sustained inflations at high airway pressures, have     been advocated as an adjunct to mechanical ventilation in lung protective ventilation     strategies to prevent the collapse of the lung.      This study aims to determine the safety and efficacy of a recruitment manoeuvre, by     considering its impact on gas exchange, hemodynamics and on the release of systemic     inflammatory mediators.   "
245303|NCT01070706|"     Phase Ib part:      ▪ Primary objective: To demonstrate the recommended dose of the combination of paclitaxel,     gemcitabine, and sunitinib (sutene®) (PGS) as preoperative chemotherapy in patients with     HER2-negative operable breast cancer        -  Secondary objective:             1. To demonstrate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of               this regimen             2. To determine the safety profile                Phase II part        -  Primary objective:      To evaluate the pathologic complete response rate (pCR) to preoperative administration of PGS      ▪ Secondary objective:        1. To assess breast conserving rate after preoperative PGS        2. To evaluate clinical response rate, disease free survival (DFS), and overall survival          (OS)        3. To assess the safety profiles of PGS   "
245304|NCT01070719|"     This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed     to assess the biochemical, immunological and pharmacokinetic profiles of a large, actively     infusing natalizumab patient population. A duration effect for progressive multifocal     leukoencephalopathy (PML) risk associated with natalizumab therapy appears to exist. There is     minimal data available to understand this effect at the biochemical and cellular level. The     purpose of this study is to gather preliminary data on several parameters to guide in more     focused research on the duration effect.   "
245305|NCT01070732|"     The present study is aiming to unravel the clinical efficacy of intravenously administered     paracetamol as antipyretic and analgesic medication in various medical conditions.   "
245306|NCT01070745|"     Patency of the ductus arteriosus (PDA) is functionally essential for fetal circulation,     however persistence of ductal patency postnatally may have significant adverse hemodynamic     effects in the neonate. Medical therapy for PDA predominantly involves the administration of     one of two non-steroidal anti-inflammatory drugs: indomethacin or ibuprofen. Both of these     therapies have been shown to be successful in mediating ductal closure in approximately 70%     of treated infants.      However, the need for a second course of treatment for PDA closure remains quite common. The     investigators hypothesize that, because of small differences between the two drugs, a greater     percentage of infants who did not respond to a first course of therapy with indomethacin will     respond to a second course with ibuprofen than to a repeat course of indomethacin.      As such, the investigators aim to compare secondary therapy with a repeat course of     indomethacin to secondary therapy with ibuprofen in infants whose ductus remained patent     after a first course of therapy with indomethacin.   "
245307|NCT01070758|"     The purpose of our study is to evaluate the efficacy and safety of Lanreotide Autogel in     children with congenital hyperinsulinism already treated with Octreotide by pump.      Congenital hyperinsulinism is a genetic disorder characterized by inappropriate insulin     secretion resulting in persistent hypoglycemia (low blood sugars. Patients exposed to     recurrent hypoglycemic episodes are at increased risk of developmental disorders, so     identification and prompt management of patients are essential. Many patients are treated     with the somatostatin analog Octreotide which is administered by continuous infusion using a     pump (we use an insulin pump). This treatment may pose a huge burden and be stressful for     patients and families as it demands intensive daily care. In an effort to simplify the daily     care of our patients and improve their quality of life we will study the efficacy and safety     of Lanreotide Autogel - a long-acting somatostatin analog that can be administered by     injection once a month   "
245308|NCT01070771|"     The use of coronary angiography to investigate patients at risk of coronary artery narrowings     has become universal. In most cases, this investigation leads to a successful treatment plan     with revascularisation recommended where appropriate. However in a substantial number of     patients, the images taken of the coronary arteries can lead to diagnostic uncertainty.     Increasingly, doctors are using devices called pressure wires to clarify the significance of     coronary artery narrowings in order to tailor patient treatment on an individual basis.      The Radi pressure wire is well recognised as a reliable tool in assessing whether a narrowing     is significant in functional terms, that is, does it significantly restrict blood flow to the     heart muscle.It consists of a fine wire that is fed into individual major coronary arteries     to measure pressure within the vessel itself. In conjunction with the images taken of the     arteries, it is very useful in deciding how best to treat patients.      This study enrolls volunteers who are being investigated for stable cardiac-sounding chest     pain and are undergoing a coronary angiogram. It will investigate whether the extra     information gained from pressure wire assessment will change patients' treatment plan.   "
245309|NCT01070784|"     The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler     compared to standard COPD treatment during one year in Japanese patients with COPD.   "
245310|NCT01070797|"     Patient's on this protocol have a type of blood cell cancer, other blood disease or a genetic     disease and have received a stem cell transplant. The donor of the stem cells was either a     brother or sister, another relative, or a closely matched unrelated donor. The patient is     being asked to participate in this study which tests if blood cells from the donor that have     been grown in a special way, can prevent or be an effective treatment for early infection by     three viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) and adenovirus.      Adenovirus is a virus that usually causes symptoms of a common cold, but can cause serious     life-threatening infections in patients who have weak immune systems. It can affect the lungs     and cause very serious pneumonia, and can also damage the gut, liver, pancreas and eyes.CMV     can also cause serious infections in patients with weak or suppressed immune systems. It     usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut,     the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body.     In healthy people CMV rarely causes any problems because the immune system can keep it under     control, but after a transplant, the risk of developing CMV disease is much higher because     the immune system is so weak. EBV is the virus that causes glandular fever. It is also a life     long infection like CMV that is normally controlled by the immune system. When immunity is     weak, the virus can become active and cause fevers, enlarged lymph nodes and sometimes a type     of cancer called lymphoma.      Investigators want to see if a kind of white blood cell called T lymphocytes (T cells)can be     used to prevent and treat adenovirus, CMV and EBV in the early stages of reactivation or     infection. T cells have been grown from the patient's stem cell donor in the laboratory in a     way that will train them to recognize the virus and control it when they are given after a     transplant. This treatment with specially trained T cells (also called CTLs) has had activity     against these viruses in previous studies and in this study investigators want to see if they     still have activity when they are made in a simpler and faster way. These donor-derived     multivirus-specific special cell lines are an investigational product not approved by the     Food and Drug Administration.      The purpose of this study is to evaluate whether donor-derived multivirus-specific special     cell lines are safe and can control three viruses: EBV, CMV and adenovirus.   "
245311|NCT01070810|"     The major goal of this project is to determine whether the use of thiamine in patients with     septic shock will result in attenuation of lactic acidosis and a more rapid reversal of     shock.   "
245337|NCT01071161|"     The purpose of this study is to demonstrate the efficacy of azithromycin to produce a     significant change in the cough-related health status, measured with the Dutch version of the     Leicester Cough Questionnaire in patiënts with COPD gold classification 2-4 and chronic     productive coughing.   "
245312|NCT01070823|"     The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing     multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for     such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay     in a plasma matrix and to determine changes in anti-JCV antibody status over time.   "
245313|NCT01070836|"     The primary objective of this study is to demonstrate that the incidence of progressive     multifocal Leukoencephalopathy (PML) in natalizumab-treated participants who do not have     detectable antibodies to John Cunningham virus (JCV) (antibody negative) is lower than in     participants who have detectable antibodies to JCV (antibody positive).      The secondary objectives of this study are to: Estimate the incidence of PML in     natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody     positive, based on a meta-analysis of data obtained from this study and other data sources;     Define the prevalence of anti-JCV antibody in relapsing multiple sclerosis (MS) participants     receiving natalizumab within the TYSABRI Outreach: United Commitment to Health (TOUCH)     Prescribing Program; Determine changes in anti-JCV antibody status over time.   "
245314|NCT01070849|"     Background:      In chronic back pain, rehabilitation specific aftercare programs, needed for a long-term     improvement of pain and functional ability, are absent. Purposeful and differentiated     aftercare treatments offer the possibility, in particular in the rehabilitation of chronic     back pain, to increase the sustainability of positive effects of a mostly three weeks taking     rehabilitation or to intensify them.      Hypothesis:      The implementation of a developed bio-psycho-social aftercare intervention program for CLBP     (RÜCKGEWINN) leeds to a better rehabilitation outcome in comparison to current usual     aftercare (IRENA) and a control group in view of pain-conditioned functional ability and back     pain episodes.      Methods/Design:      A multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants     will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to     either one of the three study arms. Outcomes are measured before and after rehabilitation and     twelve month after dismissal form rehabilitation into the aftercare program.   "
245315|NCT01070862|"     The aim of the study was to evaluate efficacy and tolerability of Thalidomide in first-line     treatment of multiple myeloma as induction treatment in young patients, with Dexamethasone     before autotransplant, and in elderly patients in combination with conventional chemotherapy     and as consolidation/maintenance therapy in young and elderly patients at plateau-phase.   "
245316|NCT01070875|"     This study is designed to assess the incidence of abnormal partial thromboplastin time in     patients receiving unfractionated heparin (UFH) 5000 U 2 times a day versus 3 times a day.      The basic hypothesis of this study is that patients receiving UFH 5000 U subcutaneously 3     times a day will have a higher proportion of elevated partial thromboplastin time than     patients receiving UFH 5000 U subcutaneously twice a day.   "
245317|NCT01070888|"     The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new     combination asthma medication, is more effective than budesonide alone in controlling     exercise induced asthma.      The investigators hypothesize that in children and adults who suffer from asthma and exercise     induced asthma there will be less decline in lung function associated with exercise when they     receive the study medication.   "
245318|NCT01070901|"     Immunosuppressive therapy protocols in solid organ transplantation are rudimentary, differ by     transplant center and no practical strategies are available to guide an individuals' response     to immune suppression. In this study we will conduct research to assess immunologic status in     solid organ transplant recipients, predicting immune reconstitution and outcomes after     transplant to better guide the use of immunosuppressive medications.   "
245319|NCT01070914|"     Primary Ciliary Dyskinesia (PCD) is a severe genetic disorder caused by various mutations in     genes affecting ciliary motility. Various new and complementary diagnostic techniques,     including measurements of nasal nitric oxide (NO), Video Microscopy (VM), Immunoflourescence     (IF) and genetic analysis have recently been recognized as simpler and more accurate     modalities for the diagnosis and characterization of patients with PCD compared to electron     microscopy. While considered a rare disease worldwide, PCD is more prevalent among highly     consanguineous populations, such as those found in Israel. We hypothesize that using modern     state of the art and novel test modalities on a national scale in Israel will improve     diagnosis, improve phenotypic-genotypic correlations and create a national registry for PCD.   "
245320|NCT01070927|"     This study will evaluate the anti-tumour activity, safety and tolerability of RO4929097 as     monotherapy in patients with recurrent or refractory non-small cell lung cancer. Patients     will receive oral doses of RO4929097 of 80mg (cohort 1) or recommended Phase II dose (cohort     2) on a 3 days on 4 days off schedule. Anticipated time on study treatment is until disease     progression or unacceptable toxicity. Target sample size is <50.   "
245321|NCT01070940|"     The purpose of this study is to investigate the effect of different levels of nitric oxide     inhibition on blood pressure and arterial stiffness in healthy subjects. L-NMMA, an inhibitor     of the nitric oxide synthase, is administered as bolus injection followed by continuous     infusion, and is expected to raise blood pressure and arterial stiffness according to L-NMMA     dose.   "
245322|NCT01070953|"     This survey is conducted for preparing application materials for re-examination under the     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the     clinical usefulness of EZETROL® through collecting the safety information according to the     Re-examination Regulation for New Drugs.   "
245323|NCT01070966|"     This survey is conducted for preparing application material for re-examination under the     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the     clinical usefulness of VYTORIN through collecting the safety and efficacy information     according to the Re-examination Regulation for New Drugs.   "
245324|NCT01070979|"     Multicenter, double-blind, controlled, parallel group, randomized study to compare the     clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine     estrogen tablets, each administered orally, once daily, to postmenopausal women.   "
245338|NCT01071174|"     This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety     of a silicone elastomer vaginal ring containing 25mg dapivirine.   "
245325|NCT01071005|"     The primary objective of this study is to examine, in healthy subjects, the comparative     pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical Pharmaceutical     Laboratory Bergamo Ltda with the product Lupron Depot ® (leuprorelin), manufactured by Abbott     Laboratories Ltd, through the strength of biological markers follicle stimulating hormone     (FSH), luteinizing hormone (LH) and total testosterone, associated with the activity of the     substance.      Secondarily be observed safety (tolerability) of subjects in clinical research through the     comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse     events.   "
245326|NCT01071018|"     This study is designed to evaluate the safety and tolerability, pharmacokinetics,     pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day     (QOD) and Once Weekly (QW) dosing schedules.   "
245327|NCT01071031|"     The purpose of the study is to see whether a single vaccination (injection) with the     investigational HIV vaccine is safe and effective in patients who are HIV positive but have     not yet begun anti-retroviral therapy. As this is an exploratory study, four different dose     formulations of HIV vaccine will be investigated.      This study will evaluate whether or not the HIV vaccine is able to reduce the HIV viral load     (number of HIV virus particles in the blood) and increase or slow the decline in CD4 T cell     count.   "
245328|NCT01071044|"     Over the past decade, the Rochester Center for Behavioral Medicine (RCBM) has evaluated many     patients with attention deficit hyperactivity disorder (ADHD). A recurrent finding in these     patients is a history of unexplained fatigue and musculoskeletal pain.      Treatment of these patients in our clinic has revealed that when their underlying ADHD is     treated with psychostimulant medication, many patients report significant improvements with     regard to their fatigue and musculoskeletal pain. Patients report less subjective fatigue and     pain and note overall functional improvement, although the initial and primary objective was     the treatment of their attention or hyperactivity problems. We speculate that stimulants are     efficacious by offering two distinct clinical properties. 1) anti-fatigue properties and 2)     properties that allow patients to filter out extraneous stimuli (i.e. chronic muscle pain).   "
245329|NCT01071057|"     The purpose of this study is to improve how we treat itching, a common side effect associated     with the use of morphine pain medication. Itching is a problem experienced by up to 30% of     the children treated with pain medications in the morphine family.      Despite studies demonstrating the effectiveness of using naloxone to treat itchiness in     adults receiving morphine pain medications, there are not many studies in children. This     study is designed to study how well naloxone works for treatment of itching in children   "
245330|NCT01071070|"     Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in     Chronic Kidney Disease   "
245331|NCT01071083|"     This is a randomized, rater blinded trial in patients who interrupt treatment with     natalizumab with or without being treated with other immunomodulatory drugs, or continue     treatment with natalizumab.      The main purpose of this study is to find out the following, when participants stop taking     natalizumab for 24 weeks:        -  when MS symptoms return, and        -  if other drugs for MS may help control MS symptoms during the natalizumab-interruption          period.      This study will also explore how quickly the effects of natalizumab return after resuming     natalizumab dosing.   "
245332|NCT01071096|"     Twenty patients will be enrolled in a 2-site, 7-month, double-blind study conducted to     evaluate a reduction in headache days and attacks and calcitonin gene-related peptide (CGRP)     levels in saliva following treatment with OnabotulinumtoxinA versus saline.      Eligible patients will be randomized and receive injections of OnabotulinumtoxinA or Saline     at Visit 1. Following 3 months plus a 1 month wash out, patients will receive cross-over     injections at Visit 5.      Patients will return for monthly visits and exit the study at Visit 8.      Patients will collect saliva at monthly intervals and document in a daily headache diary     throughout the study .   "
245333|NCT01071109|"     A majority of women with breast cancer receive radiation therapy, and many of them experience     the debilitating side effects of fatigue and insomnia. There is a need for an effective     treatment that could ameliorate these symptoms and improve quality of life in the radiation     therapy population.      The primary purpose of the proposed research is to study the impact of massage therapy as a     tool for the management of fatigue and insomnia experienced by women diagnosed with breast     cancer and receiving radiation therapy.      The secondary purpose is to explain, at the biochemical level, the effect of therapeutic     massage on the level of fatigue and insomnia in radiation therapy patients. Prior studies     have shown an association between fatigue and insomnia in the breast cancer patient following     radiation therapy and the presence of inflammation as evidenced by increased proinflammatory     cytokine production. The investigators hypothesize that therapeutic massage will ameliorate     the symptoms of fatigue and insomnia associated with radiation therapy, and will be     associated with a reduction in the plasma levels of interleukin-6 (IL-6),soluble IL-6     receptor (sIL-6R/CD126), and C-Reactive Protein (CRP). This reduction in proinflammatory     biomarkers will be due to the activation of the cholinergic anti-inflammatory pathway via the     activation of the vagus nerve.   "
245334|NCT01071122|"     To determine whether the combination of nifedipine GITS and valsartan is more effective in     reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine     whether nifedipine GITS is comparable to valsartan   "
245335|NCT01071135|"     The purpose of the study is to determine the effect of Quetiapine in patients with     schizophrenia induced by cannabis abuse.   "
245336|NCT01071148|"     The primary objective of this observational study is to assess the cumulative rate of ongoing     pregnancy at 10 ±2 weeks after hCG administration in a new series of IVF-treatment cycles in     a total of 176 subjects, who have undergone three or more previous IVF-treatment cycles     without live birth. Secondary objectives include subgroup analysis on the effect of age on     the likelihood of pregnancy at 10 ±2 weeks after hCG administration in a new series of     IVF-treatment cycles in patients < 35 years and ≥ 35 years, who have undergone three or more     previous IVF-treatment cycles without live birth.      The information obtained from this trial will be helpful for subjects who are considering     further IVF treatments and for IVF centres, as well as for the formulation of governmental     policies regarding healthcare reimbursement in Norway.   "
245340|NCT01071200|"     The present study was designed to investigate, in hyporesponder subjects, that required in a     previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH)     >3500 International Unit (IU), the possibility to decrease through recombinant human     luteinizing hormone (r-hLH) supplementation, the FSH amount per oocytes retrieved and in the     mean time to improve the overall cycle outcome.   "
245341|NCT01071226|"     T cell depletion utilizing the CliniMACS device will allow more precise, specific and     controlled graft engineering of peripheral blood stem cells from unrelated and partially     matched related donors without an increase in relapse or graft rejection and grade III or IV     acute graft versus host disease (GVHD).   "
245342|NCT01071239|"     The trial proposed is a single arm phase II treatment protocol designed to examine     engraftment, toxicity, graft-versus-host disease, and ultimate disease-free survival     following a novel cytoreductive regimen including busulfan, cyclophosphamide and fludarabine     and anti-thymocyte globulin (ATG- a non-chemotherapy drug whose role is to kill your immune     system) for the treatment of patients with Fanconi anemia who have severe aplastic anemia     (SAA), or myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML), lacking     HLA-genotypically identical donors using stem cell transplants derived from (1)     HLA-compatible unrelated donors or (2) HLA haplotype-mismatched related donors.   "
245343|NCT01071252|"     The purpose of the study is to determine whether, in patients with moderate to severe     plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis     symptoms and the extent to which the patient's body area is affected by the disease (compared     to placebo).   "
245344|NCT01071265|"     Main Research Questions:        1. Is a large trial of patients undergoing heart surgery comparing a simple procedure of          temporarily stopping blood flow to the leg with a blood pressure cuff (called remote          ischemic preconditioning) to a sham procedure possible?        2. Does the remote ischemic preconditioning procedure before heart surgery help protect the          heart and kidneys?      What is Being Studied:      A simple procedure known as remote ischemic preconditioning. The procedure is performed by     inflating a pressurized cuff the thigh to temporarily stop blood flow to the arm or leg. This     procedure causes the body to have a stress response that, at the cellular level, may protect     major organs like the heart and kidney from the damage caused to them by the much larger     stress of cardiac surgery. Reducing this damage may improve patient's recovery after surgery     and help them live longer.      Why is this study important?:      This research is important because up to 1 in every 20 patients that undergo heart surgery     die before even leaving hospital. Preventing heart and kidney damage at the time of surgery     with remote ischemic preconditioning may reduce patient deaths.   "
245345|NCT01071278|"     The aim of this observational program is to generate data on the use of Tredaptive (nicotinic     acid/laropiprant) for lipid management under routine medical practice conditions.   "
245346|NCT01071291|"     This study will evaluate whether chronic dosing with Niaspan™ increases reverse cholesterol     transport, high-density lipoprotein cholesterol (HDL-C) levels, and fecal excretion of     cholesterol.   "
245372|NCT01071642|"     The aim of the current study is to evaluate prospectively whether concomitant administration     of RAAS blockers (namely ACE-I and ARBs') influence the change in estimated GFR (eGFR) after     administration of contrast media in patients undergoing non-emergent coronary angiography.   "
245347|NCT01071304|"     The purpose of this study is to compare the pharmacokinetic profile of midazolam given alone     and midazolam given after multiple oral doses of 40 mg ridaforolimus.      Part 1 of this study is designed for evaluating CYP3A4 activity following 5 days of dosing of     ridaforolimus and is not designed with efficacy endpoints. Part 2 is a compassionate-use     extension to give patients an opportunity to receive a clinically active dose of     ridaforolimus. Part 2 dosing is open ended with limited data collection.   "
245348|NCT01071317|"     Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder     is often not diagnosed and not appropriately treated. The goal of this proposal is to     determine whether a migraine protocol designed for use in an emergency room can be used to     deliver the headache care that many migraine patients never receive. This is a randomized     trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care     or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the     following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational     intervention, reading material, and headache diaries, 3) two migraine specific medications     and 4) expedited referral to a headache specialist, if needed. Patients in the typical care     arm will receive whatever intervention the emergency physician feels is most appropriate. We     intend to enroll 21 patients in each arm of this study for a total of 42 patients. Using     headache surveys, we will determine if the protocol improves migraine-related pain and     functional disability one month after the ER visit.   "
245349|NCT01071343|"     A growing number of critically ill patients survive intensive care to be discharged from     hospital. However, critical illness and prolonged bedrest are associated with muscle wasting     with subsequent implications for recovery of normal physical function. Thus, one year after     discharge, survivors of septic shock have reported prolonged and severe impairment of     physical function.      Early interventions employed in the ICU to counteract loss of muscle mass may potentially     improve physical outcome and reduce the overall burden of critical illness. As a potential     supplement to physical therapy, transcutaneous electric muscle stimulation (TEMS) is a     non-invasive method directed at maintaining skeletal muscle function through artificially     induced contractions that are independent of patient efforts. TEMS has previously proven     effective at preventing loss of muscle mass and force in a number of non-ICU patient groups,     but has only been assessed sparsely in an ICU population where both immobilisation and     systemic inflammation are present.      Therefore, the aim of the present study was to assess the effect of early TEMS on muscle     volume in patients admitted to the intensive care unit with septic shock. The investigators     hypothesized that this intervention would preserve muscle volume during septic shock.   "
245350|NCT01071356|"     A Stage 2 randomized clinical trial (RCT) is proposed to test the efficacy of a promising     9-session model of motivational interviewing (MI) for methamphetamine (MA) dependence. Stage     1 pilot testing indicated the intervention could be easily learned and implemented with     fidelity. The sample of 30 MA dependent individuals over 9 weeks showed large reductions in     MA use, good retention and consistent attendance. The tailored treatment approach draws upon     our previous conceptual papers on MI as well as our experience with a variety of MI     protocols, including two Clinical Trials Network (CTN) studies of MI. An innovative feature     of the Higher Dose Motivational Enhancement Therapy manual is that it comprehensively     addresses the issues of clients who have achieved sustained sobriety as well as those still     using substances. Thus, it is designed to facilitate treatment entry and engagement as well     as maintenance of the gains made in treatment. We posit that a more intensive MI model is     necessary to address MA dependent individuals because they frequently present more serious     problems than individuals with other substance dependencies and are more prone to lose the     gains they make in treatment. MA dependent clients (N=220) will be recruited from New Leaf     outpatient treatment in Lafayette, California. This site has a long history of conducting     research, including participation in a multi-site study assessing treatment outcome of MA     dependence. Study participants will be randomly assigned to 1) a single session of     Motivational Interviewing (MI) plus 8 hours of health/nutrition education, or 2) the     intensive 9-session MI intervention. In addition to the study interventions, both groups will     receive standard outpatient treatment services at New Leaf. Study participants will be     assessed weekly during the first 9 weeks of treatment for MA use. More extensive assessments     will be conducted at treatment entry and 2-, 4-and 6-month follow-ups. Two therapists will be     crossed and treat clients in both conditions. Primary outcome measures will be the Timeline     Follow Back (TLFB) for MA use, MA urinalysis results, and retention in treatment. Secondary     outcomes will include Addiction Severity Index scales and the TLFB for alcohol and other     drugs. Exploratory analyses will examine HIV risk behaviors, motivation, and service     utilization. A mediation model will build upon MI research by Moyers et al. (2005) and our     construct of supportive confrontation (Polcin, et al., 2006) by testing whether feedback     enhanced with warnings about the potential harm of MA use facilitates the therapeutic     alliance, and whether this in turn facilitates better outcome. The significance of the study     is highlighted by a recent meta-analysis finding higher doses of MI were associated with     better outcomes (Burke et al., 2003). Conversely, several recent studies of standard single     session MI with drug dependent clients questioned its effectiveness, while other studies     found improvement in retention but not substance use. Clients with MA dependence are good     candidates for a more intensive dose of MI because of their severe medical and psychosocial     problems. Thus, it is time to test this promising, 9-session MI manual as a useful extension     of standard MI for clients with MA dependence.   "
245351|NCT01071369|"     To study improvements or lack thereof with the interlaminar epidural patients with or without     steroids experiences mid back, upper back or neck pain with or without chest wall and upper     extremity pain of at least 6-months duration non-responsive to conservative management.   "
245407|NCT01072097|"     This is a placebo controlled trial investigating the effect of 6 months atorvastatin 20mg/day     therapy on androgens, glucose metabolism and inflammatory markers in women with PCOS.      We assume that during 6 months atorvastatin therapy a significant improvement in     hyperandrogenism, glucose metabolism and inflammatory markers is observed.   "
245352|NCT01071382|"     Increasing air travel has resulted in a significant increase in aeromedical evacuation over     the past decade. However there is only a small amount of epidemiological data available on     the diagnosis, costs and transport characteristics of aeromedical evacuation cases. In the     present study Cases of aeromedical evacuation by a relief organization (Workers' Samaritan     Federation Germany) were analyzed based on the following criteria: age, sex and diagnosis of     the patient, ventilation mode, days of illness before transport, type of transport, flight     routes, flying time, flight distance, type of aircraft, type and distance of connecting     transport from the destination airport to the final hospital, total cost per repatriation,     and costs per flight-minute of each transport type.   "
245353|NCT01071395|"     This study will evaluate the responsiveness of a variety of available dyskinesia rating     scales to treatment with amantadine or placebo in Parkinson's disease patients with     dyskinesia. The study will be a parallel, double-blind, randomized trial of 68 patients     treated with amantadine or placebo for 8 weeks. Pre-treatment evaluations will be performed     and compared to end of study evaluations on the best treatment dose (200 or 300 mg amantadine     or matching placebo) daily. Safety evaluations will be conducted.      The responsiveness of the different scales will be evaluated statistically with a mixed model     in which changes in the outcome measures over time will include a fixed effect of treatment     group assignment. The model will additionally account for random effects of intercepts (the     scale scores at baseline) that will include both random variation (person-specific) and     specific variation associated with rate of change in outcome. The investigators may include     adjustments for possible confounding covariates, including baseline demographics and center.     The goal of the program is to provide researchers with the best scale(s) to distinguish     dyskinesia change in Parkinson's disease (PD) associated with amantadine in comparison to     placebo and to establish the magnitude of effect achievable with amantadine as a comparator     gold standard that must be met or surpassed by future anti-dyskinetic agents. Additionally,     with the use of paper and pencil questionnaires, the study will investigate the impact of     patient optimism and patient and rater expectation of positive effects on the dyskinesia     rating outcomes.   "
245354|NCT01071408|"     The purpose of this study is to determine whether an outpatient program can reduce the risk     of recurrent stroke.   "
245373|NCT01071655|"     The purpose of the study is to evaluate the efficacy and safety of the capecitabine or     5-fluorouracil selection, according to polymorphisms in TS-3'UTR and ERCC1-118, to be     combined with oxaliplatin or irinotecan as first-line chemotherapy in advanced colorectal     cancer   "
245427|NCT01072357|"     The leading risk factor for corneal transplant rejection is abnormal blood vessel growth of     the host bed. Vascular endothelial growth factor (VEGF) is thought to be a mediator of this     corneal neovascularization (NV), therefore we would like to test the safety and efficacy of     local VEGF blockade in the promotion of graft survival in high risk corneal transplants.   "
245889|NCT01073956|"     The purpose of this study is to determine the efficacy of electrotherapy as a coadjuvant in     mobility and exercise treatment in the reduction of pain intensity in subacromial impingement     syndrome.   "
245355|NCT01071421|"     The association of sleep apnea-hypopnea syndrome (SAHS) with the infections of the lower     airway has not been studied. The aspiration of secretions of the upper airway and the     colonization by microorganisms is considered a main event in most of the cases of community     acquired pneumonia (CAP) , and specially in the nosocomial pneumonia. The silent aspiration     to the lower airway is a common phenomenon in normal subjects during the sleep and some     studies has reported that the patients with SAHS present an increase of the risk to     pharyngeal aspirations. In fact, the presence of nasal and bronchial inflammation in patients     with SAHS is a recognized event. The patients with SAHS could have a risk increased to     develop pneumonia due to predisposition to the pharyngeal microaspiration to lower airways     during the sleep and other mechanical factors associated. The prevalence of SAHS in patients     with CAP could be increased as regards the data published for the same Spanish population.     The presence of an apnea-hypopnea index (AHI) could be a risk factor not only to to CAP but     to to present a unfavorable clinical evolution in comparison to patients with CAP with a     normal AHI. The aim of this study will establish a relation between SAHS and the pneumonia     risk.   "
245356|NCT01071434|"     This study aims to investigate and optimize imaging sequences and parameters of rapid     real-time MRI in order to obtain adequate guidance for accurately and precisely delivering     radiation to moving abdominal and thoracic tumors.   "
245357|NCT01071447|"     Randomized controlled trial including 100 subjects with rheumatic diseases and biological     treatment with a 28 point-Disease Activity Score(DAS28)3.2 or less. The subjects will be     randomized to either nurse-led clinic or rheumatologist-led clinic. The hypothesis is that     there will be no difference in DAS28 between the two groups after 1 year follow-up.   "
245358|NCT01071460|"     Purpose of this registry is to determine the efficacy and safety of the self-expanding, extra     flexible FlexStent in patient with superficial femor/popliteal artery disease.      The stent has been developed to cope with the extreme requirements of the femoral artery/knee     artery and is approved for usage at humans (EC-certified). It is designed to treat narrows of     the femoral- and knee artery.      100 patients at 5 German hospital shall be enrolled. After stent implantation follow-up     visits at 6 and 12 month take place.   "
245359|NCT01071473|"     This application proposes a prospective, single arm feasibility clinical trial of a 12-week     period of combined endurance and resistance training in survivors of childhood cancer who     were treated with doxorubicin and/or daunorubicin and have impaired cardiac function.      Baseline and post intervention imaging, laboratory, and neuropsychological evaluations will     be used to determine the effects of the intervention on body composition, serum lipid     profile, exercise tolerance, and neurocognitive functioning. Participants will be called     weekly to monitor compliance with the intervention. Incentives will be given at intervals     during the trial to optimize compliance with the intervention.   "
245360|NCT01071486|"     Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in     this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be     included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be     investigated using real time PCR. A correlation between pharmacokinetic parameters and     patients polymorphism will be performed using known statistical technics for comparison. The     aims of this study are, to correlate the demographic data, clinical presentation, clinical     outcomes of the included individuals, the BU kinetics and the GST polymorphism and to     establish an outcome map for those who receive HSCT for their primary disease.   "
245361|NCT01071499|"     The purpose of this study is to identify and collect samples from children who have taken a     single oral dose of the pain medication morphine, and to determine the genetic differences in     the way children metabolize (break down in the body and how it affects them) morphine.   "
245362|NCT01071512|"     The long-term objective is to further establish the role of Tysabri in preventing     neurological degeneration in multiple sclerosis (MS) and to establish powerful and efficient     new markers for neurological degeneration in MS. The study intends to correlate cognition     with two instruments and their measurements-MRI and OCT (optical coherence tomography).   "
245363|NCT01071525|"     1. Treatment of Hypercholesterolemic patients with niacin will cause a significant decrease          in oxidative stress and a decrease in the atherogenecity in blood samples of the          patients.        2. A possible correlation between oxidative stress in hypercholesterolemic patients taking          niacin to clinical hypercholesterolemia parameters is possible.        3. Using a novel biomarker will enable a precise detection of the change in the oxidative          stress in hypercholesterolemic patients.   "
245364|NCT01071538|"     The goals of this pilot study are to gather data about the safety and clinical effect of     low-dose buprenorphine in older adults with treatment resistant depression.   "
245365|NCT01071551|"     Childhood socioeconomic status (SES) is related to poor physical health, obesity, elevated     cardiovascular risk factors and iron deficiency anemia. We plan to offer a comprehensive     framework allowing the Nutrition Enrichment and Healthy Living Model (NEHLM) among a low     SES Kindergarten children. The model offered is designed to take into account the current     economic status of the child's family. We shall conduct a randomized controlled trial to     assess the efficacy of the intervention.      Our main objective:      To compare the influence of the intervention on changes in food consumption, physical     activity and ,and caries rates in the children in kindergartens where it is applied versus     the control kindergartens.      The research hypothesis:      Integrative Nutrition Enrichment and Healthy Living Model (NEHLM) will improve health     behaviors among children and parents in comparison to control intervention (physical activity     only).   "
245366|NCT01071564|"     This phase I trial studies the side effects and best dose of RO4929097 (gamma-secretase/Notch     signalling pathway inhibitor RO4929097) when given together with vismodegib in treating     patients with breast cancer that is metastatic or cannot be removed by surgery. RO4929097 may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as vismodegib, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving RO4929097 and vismodegib together may slow the growth of tumor cells and     may be a more active treatment for advanced breast cancer.   "
245367|NCT01071577|"     Background:        -  Bone marrow stromal cells (BMSCs) can be grown from bone marrow provided by healthy          volunteers. Volunteer bone marrow donors for BMSCs are generally required to meet the          same healthy history and infectious disease marker screening criteria as volunteer blood          donors. BMSCs are being used to treat a number of immune system and cardiovascular          disorders, including graft-versus-host disease (GVHD), heart disease, and vascular          disease. The National Institutes of Health Clinical Center is interested in collecting          bone marrow aspirates and biopsies from healthy volunteers to produce clinical-grade          BMSCs to treat Clinical Center patients.        -  This study will also collect bone marrow from autologous donors (donors who will later          receive their own BMSCs) for further treatment.      Objectives:      - To collect bone marrow aspirates and biopsies from healthy subjects and autologous donors     in order to produce BMSCs.      Eligibility:      - Individuals at least 18 years of age who are either healthy volunteers or individuals who     will need to receive their own BMSCs.      Design:        -  Prospective healthy volunteers will be asked a series of questions designed to identify          exposure to human immunodeficiency virus (HIV), hepatitis B or C, or other          transfusion-transmitted diseases. A blood sample will be collected and tested for the          abovementioned diseases and for other problems that may prevent bone marrow donation.        -  Prospective autologous donors will also have blood tests to evaluate their own          suitability for bone marrow donation.        -  Eligible participants will be scheduled to provide a marrow aspirate/biopsy, taken from          the upper part of the thigh bone, using standard bone marrow donation techniques.        -  The collected bone marrow will be processed into BMSCs at the National Institutes of          Health.   "
245368|NCT01071590|"     Background:      - Freezing of gait (FOG) is a common and very disabling symptom in people with Parkinson s     disease, significantly affecting their quality of life. It has been defined as a sudden break     or block in the walking motion, or as an inability to start walking. Although certain neural     connections or neurological processes might contribute to FOG, more research is needed to     produce consistent findings. Researchers are interested in investigating brain function     involved in FOG.      Objectives:      - To obtain more information on brain function in individuals with freezing of gait.      Eligibility:        -  Individuals between the ages of 45 and 80 who have been diagnosed with Parkinson s          disease.        -  Participants must be willing to go off their current Parkinson s disease medications for          up to 12 hours at a time.      Design:        -  Participants will be divided into two groups: those who do have freezing of gait (more          than about once a day) and those who have not experienced this symptom.        -  The study will involve a screening visit (1 hour) and a study visit (2 hours).        -  During the screening visit, participants will be asked about medical history, and will          have physical, neurological, memory, and walking tests.        -  Participants should not take their Parkinson's disease medications for 12 hours before          the study visit. Participants who cannot come to the clinic safely without their          medications will be allowed to stay in the hospital overnight before the visit, and          should bring their medications to the study in order to take them as soon as needed          after the study.        -  Participants will be asked to perform several tasks before the imaging study: (1)          walking 10 yards back and forth down a hallway, (2) walking 10 yards back and forth          while following horizontal lines on the floor, (3) walking 10 yards back and forth while          listening to a metronome, and (4) being pushed back and forth in a wheelchair.        -  After participants perform the actual tasks, participants will be asked to imagine          performing the tasks and fill out questionnaires about how well they can imagine the          tasks.        -  Participants will be monitored with a functional magnetic resonance imaging (fMRI) scan          while imagining the four tasks they have just performed.   "
245369|NCT01071603|"     Background:      - In spite of well-researched treatments and therapies, 5 to 10 percent of tuberculosis (TB)     patients who have initially successful TB treatments will relapse, usually within a year     after completion of therapy. This percentage is even greater for patients who are infected     with multi-drug resistant and extensively drug resistant types of TB. Because the People s     Republic of China has the second highest number of TB cases in the world, researchers are     interested in studying TB patients in China to evaluate their response to treatment on a     long-term basis.      Objectives:        -  To improve TB diagnosis and testing by determining the number and proportion of patients          admitted with suspected TB who actually have TB (definite or probable).        -  To assess the prevalence of non-tuberculosis bacteria among patients with presumed TB.      Eligibility:      - Individuals between 18 and 65 years of age who have been admitted to Henan Provincial Chest     Hospital with suspected tuberculosis.      Design:        -  Participants will be divided into three groups, based on their diagnosis after          admission. Another group of individuals who do not have TB will be enrolled as controls          for comparison purposes during the study.        -  The study will use computed tomography (CT) scans of the chest at initial enrollment, 2          months, and 6 months to evaluate disease response to treatment. Incidents of TB that are          not in the chest area (extrapulmonary TB) will also be studied.        -  The study will also monitor the treatments and therapies used against the disease,          changes in patients immune systems, and any changes in the biological samples taken over          the course of treatment.   "
245408|NCT01072110|"     The main objective of this study is to determine the frequency of different gastrointestinal     disorders as the cause of diarrhea in patients at a tertiary referral center using confocal     laser endomicroscopy.   "
245583|NCT01064024|"     This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets,     USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning     when passing urine associated with uncomplicated urinary tract infections (uUTI)   "
245370|NCT01071616|"     Background:      - Little research has been done on how different components of cannabis (marijuana) appear in     oral fluid (i.e., saliva) after smoking. Cannabinoids have been well studied in whole blood,     plasma, and urine after cannabis use, but less is known about how cannabinoids appear in oral     fluid after controlled drug administration and how long these biomarkers last after use. In     addition, the issue of stability of cannabinoids and their glucuronide metabolites is a     controversial topic that is poorly understood. These data are critical to the interpretation     of cannabinoid test results.      Objectives:        -  To collect whole blood, plasma, urine, and oral fluid specimens after smoking cannabis,          to characterize the disposition and pharmacokinetics of cannabinoids in multiple          biological matrices and to provide scientifically reliable data on the stability of          cannabinoids and metabolites.        -  To test basic brain function and thinking processes after smoking cannabis.      Eligibility:      - Healthy volunteers between 18 and 45 years of age who use cannabis (an average of at least     twice per month in the 3 months before the study.)      Design:        -  Participants may complete the single study session as outpatients, or they may spend the          night prior to and/or following drug administration at the residential research unit in          Baltimore, MD. Participants must provide a negative urine drug screen if they have not          spent the evening prior to testing at the research unit.        -  Participants will provide whole blood, plasma, oral fluid, and urine samples, and will          complete several tests of thinking and brain function at the start of the study.        -  Participants will smoke one standardized cannabis cigarette. Blood and oral fluid          samples will be collected, and participants will repeat the tests of thinking and brain          function multiple times after smoking.        -  Six hours after smoking the cigarette, participants must pass a neuromotor exam (testing          balance and coordination) before they can be discharged from the study. Participants may          be asked to stay overnight at the clinical center if there are concerns for their safety          because of intoxication.   "
245371|NCT01071629|"     Chronic heart failure (CHF) is a common syndrome characterized by several central hemodynamic     and peripheral vascular and muscle abnormalities including autonomic imbalance,     neuro-hormonal over-activation and decreased oxidative status.      In patients suffering from CHF, exercise confers several beneficial effects on the     cardiovascular and peripheral systems, mainly by continuous aerobic training. However,     interval aerobic training has also been validated as an alternate form of training that     increases the exercise capacity of patients who are in CHF.      Recent studies have suggested that resistance training alone or as a complementary program     besides the traditionally aerobic continuous training might exert favorable effects. However,     little it is known about the combined effects of interval and strength training in CHF     patients.      Aim of this prospective randomized controlled study was to investigate the effects of     combined interval and strength training comparing to interval training alone in CHF patients.   "
245374|NCT01071668|"     Premature birth is a public health problem and its incidence has recently increased in all     developed countries. In Canada, it represented 6.4% of births in 1981 and 7.6% in 2000. In     the last decade, the survival rate of premature infants has increased considerably, but     neurological vulnerability has not changed. Premature births are the cause of approximately     28% of neonatal mortality in the world and is the major cause of perinatal mortality and     morbidity in developed countries.      Approximately 75-80% of preterm births are spontaneous preterm birth. This type of premature     birth included the preterm labor and premature rupture of membranes before term. The     contractile activity represents one of the fundamental properties of the uterus during     pregnancy and childbirth. The abnormalities associated with uterine contractions are the     cause of pathological conditions with important consequences for the mother and fetus.      Metabolomics involves a new technology to investigate small molecules that characterize     biochemical pathways of interest. The change in concentration levels of these molecules in     various biological samples such as urine and blood in the presence of a disease or a patient     can be particularly useful for identifying new biomarkers.      The hypothesis of this study is that gestational metabolomes detected in maternal fluids     differ according to pathological situations and lead to the initiation of spontaneous labor.     The whole research program has two complementary objectives in order to expect a decrease of     prematurity: a) better understanding of all the physiological mechanisms leading to     prematurity and b) better identification of patients at high risk for a better management of     these women.   "
245375|NCT01071681|"     This study will describe the factors influencing the physician in face of elevated blood     pressure in already treated patients   "
245376|NCT01071694|"     This study is to describe the quality of life of Korean patients with early     relapsing-remitting multiple sclerosis during the initial 1 year of treatment with Betaferon     with several validated questionnaires.   "
245377|NCT01071707|"     Study purpose:      The disease course of idiopathic pulmonary fibrosis (IPF) is variable. During the course of     the disease some patients will get better, some will stay the same, and others will get     worse. Currently doctors do not have any way to predict an individual patients disease     course. The purpose of this study is to determine if 'biomarkers' such as proteins or genes     isolated at the time of diagnosis can be used to predict the disease course. These     'biomarkers' will be obtained from samples of blood, from a procedure call a bronchoscopy,     and in some patients from extra tissue obtained by a surgical lung biopsy.   "
245378|NCT01071720|"     The purpose of this study is to assess the effect of food on the pharmacokinetic     characteristics of CKD-501 in healthy subject.      And, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.   "
245379|NCT01071733|"     The purpose of this study is to compare fracture diagnostic, conventional x-ray versus     ultrasound.   "
245380|NCT01071746|"     Patients with acute on chronic liver failure have a risk of developing multiorgan failure and     a high mortality. The current scoring systems defining the outcome of patients with acute     decompensation of cirrhosis fail to identify patients that progress to Acute-on-chronic liver     failure (ACLF).      The aim of the study is to evaluate if one can identify these patients early on with the     proposed biomarkers: dimethylarginines and ischemia modified albumin.   "
245420|NCT01072266|"     This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060     (study drug) is safe, well-tolerated and effective in patients with advanced malignancies.     Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28     days before the next group is enrolled and may begin to receive study drug. Doses will be     escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.   "
245381|NCT01071759|"     Iron deficiency is considered one of the main nutritional deficiency disorders despite the     apparent availability of a high-quality diet even in developed countries, and Iron deficiency     anemia (IDA) is the most common form of anemia in the world. IDA during pregnancy has been     associated with adverse health consequences for both the mother and her developing fetus.     Helicobacter pylori (Hp) may be the most common bacterial infection worldwide, infecting     almost half of people in developed countries and 80% of people in developing countries. The     available data on the prevalence of Hp infection in Taiwan population was 54.4%. We all know     that infection with Hp is strongly associated with peptic ulcer and gastric cancer, but     recent evidence suggests that Hp is associated with iron deficiency and anemia, although the     mechanisms remain unclear. Till now, only few previous studies specifically have addressed a     potential role of Hp infection on anemia or iron deficiency during pregnancy. Our previous     Research showed, between the Hp infection (+) and Hp infection (-) gravidas, the associations     between the Hp infection and iron deficiency were stronger, although not statistically     significant. This might be due to that we needed more cases and evidences to prove the     relationship between maternal Hp infection and serum iron, ferritin and hemoglobin levels, or     we should further consider the interactions of the particular customs or diet preference of     the Taiwanese gravidas. This longitudinal study will recruit 140 women from the antenatal     care clinics of E-Da Hospital to examine the association between Hp infection and maternal     IDA. The standardized interviews of mothers (anthropometric data, socioeconomic status,     medical history, obstetric history, alcohol consumption during pregnancy, and history and     duration of iron supplementation during pregnancy) will be conducted, Hp infection status     will be determined by the urea breath test and IgG enzyme immunoassay, and the measurement of     hemoglobin, iron, and ferritin levels will be obtained 5 times at various antepartum and     postpartum points of time during pregnancy (routine prenatal visits of 1st, 2nd, and 3rd     trimester, puerperium and 2 weeks after delivery). We hope that we could investigate the     possible role of Hp infection in iron deficiency and iron-deficiency anemia during pregnancy     in Taiwan, and that early detection and treatment of anemia may reduce the risk of blood     transfusion and perinatal and maternal mortality.   "
245382|NCT01071772|"     Diabetes and Heart Failure are diseases with high morbidity and increased risk of death.     Former investigations has shown that diabetes worsens the prognosis of heart failure. However     it is uncertain how short term diabetic dysregulation in type 2 diabetics affect cardiac     function.      Our hypothesis is that short term dysregulation affects left ventricular function and     exercise capacity in insulin treated type 2 diabetics with and without heart failure.      To elucidate this hypothesis diabetic patients with and without heart failure will be     investigated after overnight state of either high or normal blood glucose levels on two     separate occasions. Metabolic and hormonal parameters will be measured. Systolic and     diastolic cardiac function will be assessed, exercise capacity and post exercise regional     myocardial tissue velocity as well as 6 minutes walk test will be investigated on both     occasions. The study will be a randomized cross-over design.   "
245383|NCT01071785|"     Metabolic Syndrome (MS) is an clinical condition with high cardiovascular risk. More than 80%     of DM patients had MS. Dietary factors can be associated to both, DM and MS. Therefore the     aim of this study is to evaluate the effects of add soluble fiber (goma-guar) in the usual     diet of type 2 DM with MS and compare this intervention with an usual diet without this     supplement.   "
245385|NCT01071811|"     Physical activity is associated with a reduced risk of several chronic diseases in addition     to all-cause mortality. Hence for public health purposes, knowledge of effective     interventions to increase the physical activity level in the population is important.      The objective of this randomized controlled trial was to examine the effect 12 weeks after     having received a pedometer and a pedometer program on physical activity, health     measurements, self-rated health, stress, and sleep quality.      A total of 223 men and 445 women were randomly assigned to either a pedometer group (n = 333)     in which participants received a pedometer and pedometer program or a control group (n =     335). Of the participants included in the study 198 and 178 completed the health examination,     and 192 and 187 completed the questionnaire at follow up in the pedometer group and in the     control group, respectively.   "
245387|NCT01071837|"     This is a phase II study of APG101 + reirradiation (RT) versus reirradiation. Patients     suffering from a malignant brain tumor called glioblastoma having a first or second     progression can be included. They will be randomized to RT or RT + APG101.      APG101 is a fusion protein (similar to an antibody) and will be administered as a weekly     infusion. Patients can stay in this study as long as they benefit from the participation (no     fixed end).      In this trial, 30-35 sites in Germany, Austria and Russia take part.   "
245388|NCT01071850|"     Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to     placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.   "
245389|NCT01071863|"     Primary Objective:      To identify the prevalence and severity of the fear of falling in a rheumatoid population      Secondary Objectives:      To explore the effect the treatment with biological agents has on fear of falling and     physical activity in a rheumatoid population   "
245390|NCT01071876|"     Multicenter randomized double blind study versus placebo during 12 weeks with at first, an     escalating dose period followed by stable dose period at the selected dose.      This double-blind period can be followed by a 9 months open-label period if the patient     wishes to continue with the study product.   "
245391|NCT01071889|"     The purpose of this study is to evaluate the safety and effectiveness of treatment with     sublingual (s/l) Flumazenil in healthy volunteers as reversing the effect of the     sleep/hypnotic drugs. This study is designed to collect short-term safety and tolerability     data.      In addition, the psychomotor/ cognitive and behavioral effects of Flumazenil will be assessed     to monitor the degree and the duration of action in a single use of Flumazenil.   "
245392|NCT01071902|"     The purpose of this study is to determine if Moxidex otic solution is safe and effective in     treating middle ear infections in patients with ear tubes.   "
245393|NCT01071915|"     This is an open-label, multi-centre single arm trial to investigate efficacy and safety of     degarelix in Korean patients with prostate cancer for bridging between CS21 trial     (NCT00295750) results.   "
245394|NCT01071928|"     The purpose of this study is to explore the safety and activity of docetaxel + ASA404 as     second-line chemotherapy in patients with advanced urothelial carcinoma.   "
245500|NCT01062945|"     The purpose of the study is to asses the potential interactions between intravenous cocaine     and doxazosin in cocaine dependent volunteers who are not seeking treatment. The study will     evaluate the effects of doxazosin on the cardiovascular and subjective effects of cocaine in     a human laboratory study.   "
245395|NCT01071941|"     The purpose of this research study is to determine the safety of rRp450 and the highest dose     of this agent that can be given to people safely. We are also looking to see how well the     body tolerates the study agent, how the agent is absorbed by the liver cancers, how quickly     the agent is eliminated from the body, and what kind of anti-cancer effect it may have.     rRp450 is a type of gene therapy and a form of the Herpes simplex virus 1 (or HSV). HSV is a     virus that usually causes cold sores of the mouth. In extremely rare circumstances, this     virus can cause severe infections, such as an infection of the brain. rRp450 was developed     from an HSV and specially altered to target and kill cancer cells.   "
245396|NCT01071954|"     This is an extension study designed to assess the safety and durability of platelet count     increases with romiplostim treatment of thrombocytopenic subjects with Immune (Idiopathic)     Thrombocytopenia Purpura. This study is available to pediatric subjects who have completed a     previous romiplostim ITP study and meet the eligibility criteria of this study.   "
245397|NCT01071967|"     Care coordination, disease management, geriatric care management, and preventive programs for     chronically ill older adults vary in design and their impact on long-term health outcomes is     not well established. This study investigates whether a community-based nursing intervention     improves longevity and impact on cardiovascular risk factors in this population. The results     reflect the impact of one of the study sites (Health Quality Partners) selected by the     Centers for Medicare and Medicaid Services (CMS) to participate in the Medicare Coordinated     Care Demonstration, a national demonstration designed to identify promising models of care     coordination for chronically ill older adults. The study began in April 2002.   "
245398|NCT01071980|"     The purpose of this study is to investigate the effect of specific resistance training on     neck/shoulder pain in industrial workers.   "
245399|NCT01071993|"     To determine if statin therapy plus intravenous normal saline, in patients with chronic renal     insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline     therapy in the prevention of CIN.   "
245400|NCT01072006|"     This research investigates processes involved with one being able to focus on relevant     information and ignore non-relevant information in veterans with PTSD and those with a     history of traumatic brain injury. In addition, this study evaluates whether there is an     additive effect of having both PTSD and history of TBI on ability to focus attention and     inhibit distracting information.   "
245401|NCT01072019|"     The purpose of this study is to determine the surgical and clinical outcomes of patients     receiving total knee replacement with the same implant using two different types of cutting     guides during surgery:        1. Standard knee cutting guides;        2. MRI generated patient specific custom cutting guides.      Both types of cutting guides used in this study are registered with the U.S. Food and Drug     Administration (FDA) and are routinely used for knee replacement surgery. However, it is     unknown if one type of cutting guide has risks or benefits over the other.   "
245402|NCT01072032|"     Reduced mobility is often a long-term problem facing those who have chronic leg weakness     resulting from stroke. Recent innovations in stroke therapy have applied motor learning     principles to improve motor skills through regular practice of activities using the weaker     limb. Because the ankle provides critical torques for normal walking and mobility function,     impairments at the affected ankle pose a major limitation to achieving optimal mobility     recovery. To address this we have developed a novel ankle robot (Anklebot) to enhance     physical therapy for improving walking and mobility after stroke. This computer controlled     device provides assistance when users cannot complete a movement, but will not assist if the     user is active.      Motor learning requires active involvement in task-related practice to mediate brain     plasticity. While voluntary movement is important to remodel motor control circuits, the     brain mechanisms of reward and motivation also can play an important role. Core brain     networks involved in reward and motivation increase a person's involvement with their     surroundings, to focus attention and to prompt one to approach reward and avoid punishment.     This increased involvement and the elevated emotions associated with it have been shown to     enhance performance, memory and learning.      The purpose of this study is to investigate responses of brain and motor behavior of stroke     patients who use the Anklebot during a 3-week / 3-session/week motor learning based training.     These responses are compared to a 3-week delayed entry period in which the participants will     perform an at-home walking program of equal time. After the 3-week delayed entry walking     program, subjects are divided into low and high reward-feedback groups. The low     reward-feedback group receives the Anklebot training with only immediate feedback on target     successes, without cumulative scores and with minimal social interaction with the     researchers. The high-reward group receives cumulative scores and ongoing social support, are     eligible for prizes during each session and at the study's completion. All subjects play the     games as noninvasive electroencephalography and electromyography record brain and muscle     activity. In addition to analyzing brain information before and after the Anklebot training,     ankle motor control and walking functions are also assessed immediately before and after the     first and last robotic training sessions.   "
245403|NCT01072045|"     Infantile Hemangioma (IH) is infancy's most common vascular tumor of infancy and most     frequent benign neoplasm.      Treatment of IHs is indicated for approximately 10 to 20% of the cases. Two groups can be     defined amongst indications for treatment: patients with absolute indication for treatment     and patients with relative indication for treatment.      Absolute or emergency indications comprise function or life threatening situations such as     obstruction of airways, obstruction of vision, congestive heart failure, hepatic and     coagulation problems.      The following are considered relative indications: cases of large and disfiguring facial     hemangiomas; locations that can result in a deformity and/ or permanent scar (nose, ear, lip,     glabellar area); extensive face hemangiomas, mainly when there is dermal damage (more     probable to scar); local complications such as ulceration, infection and bleeding as well as     small hemangiomas in exposed areas (hands and face), mainly if pedunculated due to its ease     of excision2,7.      Treatment modalities vary according to the extension, location, presence of complications and     the evolutional phase. A combination of various treatments is possible.      Beta blockers are being used in children for approximately 40 years, with proven clinical     safety and no cases of death or cardiovascular disease resulting from its direct use.     Recently it was reported the use of beta blockers (propanolol) for IH treatment, with     significant reduction of tumor volume after introduction of the beta blocker, in a short     period of time, with stable results after the end of treatment, which suggested evidences of     the benefits of this drug in the tumor treatment The proposal of this study is to assess the     use of propanolol in IH treatment, quantifying its effectiveness and safety under continuous     monitoring and comparing it to the use of oral corticosteroid. The investigators propose the     assessment of the betablockers' use in comparison to the use of corticosteroids in infants     with IH in the proliferative or involuting phases, with indication for clinical treatment,     and that are not alarming nor urgent; in other words, the current relative indications for     treatment.   "
245404|NCT01072058|"     The purpose of this study is to determine possible alterations in cardiac function in     patients with Rheumatoid Arthritis and Ankylosing Spondylitis under anti-TNF therapy, without     clinical heart disfunction at baseline, using highly sensitive non-invasive methods.   "
245405|NCT01072071|"     Intra-abdominal hypertension (IAH) is a frequent cause of organ dysfunction in critically ill     patients. Secondary IAH is mainly caused by excessive fluid resuscitation.The World Society     for the Abdominal Compartment Syndrome (WSACS) recommends using diuretics to remove excess     fluids and decrease intra-abdominal pressure (IAP). However, critically ill patients may not     tolerate negative fluid balance in the acute phase of their disease and the injured kidney     may not respond to diuretics. The aim of this study is to evaluate the influence of     furosemide on fluid balance, IAP and kidney function in critically ill patients.   "
245409|NCT01072123|"     This is a single center pilot study designed to evaluate the effectiveness of an asthma     education program in the pediatric emergency department. Asthma has reached epidemic     proportions. Nine million American children are affected in the United States alone. This     problem has increased 75% from 1980 to 1994, with a staggering 160% increase seen in children     less than five years old.1 The American Lung Association has targeted this overwhelming     problem on both national and local levels. Asthma impacts American communities who differ     geographically, culturally, ethnically and by lifestyle, and as a result will present with     different obstacles.      The primary objectives are: to determine whether this educational intervention (through     interactions with a child life specialist and using the asthma based computer game) in the     pediatric ED can influence children's [and care givers'] knowledge and understanding of the     disease process and treatment, and to improve asthma self-management and decrease morbidity     by decreasing ED use and hospitalization.      A secondary objective is to introduce the Child Life Specialist as an effective asthma     educator and further strengthen the health care team.      The target population will be recruited from the pediatric emergency department. We     anticipate this study to recruit over a one year period and have a one year follow up with an     anticipated enrollment of 64 children and families. There will be three Child Life Specialist     involved in this program.      After consent has been obtained, the child and parent will complete questionnaires (focusing     on asthma knowledge, quality of life, and perception of asthma) and then a laptop will be     provided to access the asthma based computer game.      During the child's ED visit the Child Life Specialist will have opportunities to open     communication to address barriers or concerns, and reinforce material provided by the game.     Through these interactions, the importance of communication between the child, parent and     healthcare provider is highlighted.      The family will be given information to access the computer game via the internet. Follow up     phone calls or e-mails will occur at 6 months, 9 months, and 12 months which will entail     completing questionnaires. The questionnaires uses validated questions along with questions     from the material covered through this asthma education study.   "
245410|NCT01072136|"     Mucopurulent cervicitis (MPC) is a syndrome with associated symptoms including mucopurulent     discharge (mucus and pus) from the cervix and other signs of inflammation such as easily     induced cervical bleeding. The purpose of this study is to evaluate the effectiveness of no     treatment versus empiric treatment with a single dose of cefixime and azithromycin for cure     of MPC. Empiric treatment is the initiation of treatment prior to a firm diagnosis. Study     participants will include 772 women ages 18 and older in good health with MPC. Women will be     randomly assigned to 1 of 2 possible study groups: Group 1 will receive a single dose of     cefixime and azithromycin antibiotics and Group 2 will receive placebo (inactive substance).     Study procedures will include pelvic examination with a cervical swab sample. Participants     will be involved in study related procedures for approximately 2 months, which includes 3     study visits.   "
245411|NCT01072149|"     The Purpose of this study is to evaluate the 24-hour spirometry effect Forced Expiratory     Volume in One second (FEV1) of 3 doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder     at the end of a 28-day treatment period in subjects with Chronic Obstructive Pulmonary     Disease (COPD) compared with placebo. Other objectives are to assess additional efficacy,     plus the safety, pharmcodynamics and tolerability of concurrent treatment with Fluticasone     Furoate (FF) plus GW642444 when administered at three dose levels for 28 days in subjects     with COPD and to assess the steady-state pharmacokinetic profile of Fluticasone Furoatee (FF)     and GW642444 at the end of each treatment period.   "
245444|NCT01072578|"     The primary objective of the study is to assess the effect of dapagliflozin on the amount of     glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus     twice a day (5 mg every 12 hours) after five days of dosing.   "
245412|NCT01072162|"     This is a randomized, open-label, five-period, balanced crossover study conducted in     approximately 40 healthy adult subjects enrolled at one study center in the USA. Subjects     receive five eltrombopag treatments: tablet fasted, Powder for Oral Suspension (PfOS) fasted,     PfOS with a high calcium meal, PfOS 2 hours prior to a high calcium meal, and PfOS 2 hours     after a high calcium meal, and each treatment is a single 25 mg dose. There is a 10 to 14 day     washout between periods, and between the last dose of study drug and the follow-up visit.     During each treatment period, subjects undergo serial PK sampling over 72 hours for     measurement of plasma eltrombopag concentrations. Safety is assessed by vital signs, clinical     safety laboratory assessments, and adverse events reporting.   "
245413|NCT01072175|"     This is an open-label, dose escalation study to investigate the safety, pharmacokinetics,     pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This     study is designed in four parts. In Part A, the effect of repeat doses of GSK1120212 on the     pharmacokinetics of single dose GSK2118436, will be investigated prior to evaluating     combination regimens. In Part B, the range of tolerated dose combinations will be identified     using a dose-escalation procedure. In Part C, different dose combinations of GSK2118436 and     GSK1120212 will be evaluated, based on results from the dose escalation cohorts. In Part D,     the pharmacokinetics and safety of GSK2118436 administered as HPMC capsules alone and in     combination with GSK1120212 will be evaluated.   "
245414|NCT01072188|"     The objective of this study is to evaluate the clinical efficacy of a prophylaxis paste     containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a     pre-procedure to a professional dental cleaning.   "
245415|NCT01072201|"     Clinical research for the treatment of mucositis subjects who have dental implants for a     minimum of one-year.   "
245416|NCT01072214|"     A study to determine the safety and tolerability of pazopanib eye drops. The study will also     determine how the drug is absorbed and metabolized over time. Repeat doses of eye drops will     be administered to healthy adult volunteers over a 14-day period with one additional dose     given on the 15th day of the session. Three groups of subjects may receive either active drug     or placebo (drops without drug). The first group of subjects will receive a maximum of 1.6mg     of pazopanib or placebo. The dose of drug to be given to the next two groups will be     determined based on the results of the first group of subjects. The last group of subjects     will be of Japanese descent.   "
245417|NCT01072227|"     The purpose of the study is to identify the bacterial aetiology of Acute Otitis Media     episodes in young children aged >= 3 months to < 5 years in Taiwan   "
245418|NCT01072240|"     This observational study will monitor and register infusion-related adverse events and their     handling in patients with chronic lymphocytic leukemia on treatment with MabThera     (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of     375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6     months. Target sample size is 100 patients.   "
245419|NCT01072253|"     The purpose of this study is to evaluate eye amputated patients health related quality of     life, perceived stress, self-rated health, labour marked participation and socio-economic     position.      The investigators hypothesis is that quality of life, perceived stress and self- rated health     of many eye amputated patients are drastically changed. Eye amputation has a marked negative     influence on labour marked participation and socio-economic position of the patients.   "
245584|NCT01064037|"     A placebo controlled, double-blind and randomized study to assess different doses of a new     drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the     well-being of patients with acute decompensated heart failure.   "
245421|NCT01072279|"     A study conducted by IFPRI in Haiti provided the first programmatic evidence, using a cluster     randomized evaluation design, that preventing child undernutrition in children under two     years of age (PM2A) through an integrated program providing food rations, BCC and preventive     health and nutrition services is both feasible and highly effective. The study's principal     aim was to compare a newly designed preventive approach with the traditional (recuperative)     food assisted MCHN program approach, and therefore included only two comparison groups: one     group of communities that was randomly assigned to the preventive approach and another group     assigned to the recuperative approach. For logistical and financial reasons, the study did     not include a randomized control group receiving no intervention.      The Haiti study design was well-suited to achieve its main goal - i.e. to test whether the     preventive approach was more effective than the recuperative approach at preventing child     undernutrition - but it left a number of questions unanswered.      The present study will address several of these questions, which will allow to further refine     the PM2A approach, facilitate its replication in different contexts, and maximize its impact     and cost-effectiveness in future programming. The study will be conducted in Guatemala and     Burundi. The key research objectives are:        1. Impact and cost effectiveness: Assess the impact and cost effectiveness of PM2A on child          nutritional status.        2. Optimal composition and size of food rations in PM2A: Assess the differential and          absolute impact of varying the size and types of foods incorporated in the food ration          of the PM2A. More specifically, assess the differential effect of different sizes of          family food rations, and assess the impact of substituting the individual food ration          with new micronutrient-rich products such as lipid-based nutrient supplements (LNS) or          micronutrient Sprinkles.        3. Optimal timing and duration of PM2A: Assess the differential and absolute impact of          varying the timing and duration of exposure to PM2A on child nutritional status.   "
245422|NCT01072292|"     A two-phase research study is being conducted. In Phase 1 of the study, the cognitive     behavioral therapy intervention for insomnia was implemented in a small (n = 5) group of     people with moderate to severe COPD and insomnia. The intervention was pilot-tested to     determine feasibility and acceptability, and the intervention will be refined as needed. In     Phase 2 of the study, a two-group randomized controlled study (n = 20) will be conducted to     test the effects of the cognitive behavioral therapy for insomnia intervention on the primary     outcomes of sleep quality and fatigue and the secondary outcomes of mood and functional     performance. It is hypothesized that people with COPD receiving cognitive behavioral therapy     for insomnia will demonstrate significant improvements in sleep quality, fatigue, mood and     functional performance as compared to people with COPD who receive a wellness program. This     research will yield valuable information regarding effective interventions aimed at     mitigating problems such as poor sleep quality, fatigue and reduced ability to perform valued     daily activities. This information will be used to increase the likelihood of long-term     successful outcomes such as the ability to maintain productive roles in society for people     with COPD.   "
245423|NCT01072305|"     Fluid restriction has become of great interest in perioperative care. There is, however, a     conflict of interest between fluid restriction and hemodynamic stability. The investigators     hypothesized that intermittent pneumatic compression may recruit blood from venous capacity     vessels of the lower limbs and thus enable fluid restriction without compromising hemodynamic     stability.   "
245428|NCT01072370|"     The purpose of this study is to test the safety and effectiveness of a cord blood infusion in     children who have motor disability due to cerebral palsy (CP). The subjects will be children     whose parents have saved their infant's cord blood, who have non-progressive motor     disability, and whose parents intend to have a cord blood infusion.   "
245429|NCT01072383|"     This Phase II clinical study is to test safety and efficacy of BT061 against psoriasis given     as repeated doses.   "
245430|NCT01072396|"     Optimal clinical management in early stages of COPD is not established. Tiotropium has been     shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV     COPD, improvements in constant speed treadmill time in a study of patients who also received     pulmonary rehabilitation in a population of patients with predominantly severe and very     severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle     Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits     of tiotropium on exercise tolerance in a patients with early stages of COPD who are     symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients)     may benefit from maintenance therapy and there is limited data on exercise limitation in     patients with early stage COPD who are symptomatic. This study is designed to evaluate the     mechanisms of breathlessness and assess physical activity limitation in early stage COPD     patients compared to age and gender matched controls and will secondly investigate the     effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise     duration as a result of the bronchodilation effects of tiotropium leading to a reduction of     dynamic hyperinflation in Early Stage COPD patients.   "
245431|NCT01072409|"     To evaluate the performance of the Nucleus 5 Cochlear Implant System.   "
245432|NCT01072422|"     The purpose of this study is to determine if an assessment protocol that measures the need     for support with smoking cessation and that will be administered by primary health care     nurses helps patients with obstructive pulmonary disease (COPD) quit smoking.   "
245433|NCT01072435|"     Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in     many ways: by infusion or intravenous boluses and with self-administration device     (patient-controlled sedation; PCS). It is not clear which method of propofol administration     would be preferable. The main objective of the trial is to compare 2 different methods of     propofol administration during ERCP: patient-controlled administration(PCS) and     target-controlled infusion (TCI).   "
245434|NCT01072448|"     This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.   "
249143|NCT01110759|"     In this study, the effects of local block vs non block will be assessed with respect to     postoperative outcomes (such as pain score, and recovery profiles) in outpatients after hand     surgery.   "
245435|NCT01072461|"     The complexity of sensorimotor control required for hand function as well as the wide range     of recovery of manipulative abilities makes rehabilitation of the hand most challenging. The     investigators past work has shown that training in a virtual environment (VE) using     repetitive, adaptive algorithms has the potential to be an effective rehabilitation medium to     facilitate motor recovery of hand function. These findings are in accordance with current     neuroscience literature in animals and motor control literature in humans. The investigators     are now in a position to refine and optimize elements of the training paradigms to enhance     neuroplasticity. The investigators first aim tests if and how competition among body parts     for neural representations stifles functional gains from different types of training     regimens. The second aim tests the functional benefits of unilateral versus bilateral     training regimens.The third aim tests whether functional improvements gained from training in     a virtual environment transfer to other (untrained) skills in the real world.   "
245436|NCT01072474|"     In the study the value of capnography for avoiding complications during sedation for ERCP is     evaluated.   "
245437|NCT01072487|"     In the study the value of capnography for avoiding complications during sedation for     colonoscopy is evaluated.   "
245438|NCT01072500|"     Based upon promising results from a pilot study among 424 sedentary older adults who were     randomized to a physical activity intervention or a successful aging health education     intervention, a Phase 3 multi-center randomized controlled trial is being conducted to     compare a moderate-intensity physical activity program to a successful aging health education     program in 1,600 sedentary older adults who are followed for an average of 2.7 years.      The primary aim was to assess the long-term effects of the proposed interventions on the     primary outcome of major mobility disability, defined as inability to walk 400 m.   "
245439|NCT01072513|"     The purpose of this study is to evaluate semen for changes following treatment with proton     radiation therapy.   "
245440|NCT01072526|"     The purpose of this study is to determine whether a homeopathic therapy in combination with     cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment     of dry eye disease.   "
245441|NCT01072539|"     The primary objective of this study is to identify any changes on the safety profile of     adverse events and serious adverse events. And the secondary objective is to evaluate     clinical response in the clinically evaluable population at test-of cure (TOC) or at the end     of treatment (EOT) assessment, and microbiologic response at the subject level, if available.   "
245442|NCT01072552|"     The hypothesis of the present study is that the prophylaxis with palivizumab to prevent the     severe RS virus infection during the infancy among preterm infants may reduce the risk of     subsequent recurrent wheezing in childhood.      The infants born between July 1st and December 31st in 2007 with the gestational age between     33 and 35 weeks were enrolled into the study at the end of RS virus infection season, April     2008. The infants were unintentionally divided into two groups, either palivizumab treated or     untreated group at the enrollment, because the timing for palivizumab prophylaxis were     already ended.      The study infants will be followed up until the age of 3 with recording the incidence of     either parent reported or physician diagnosed recurrent wheezing.      The difference of the incidence of the recurrent wheezing between the groups will be analyzed     with Kaplan-Meier method.   "
245443|NCT01072565|"     The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood     Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to     determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes     management.   "
245445|NCT01072591|"     The purpose of this study is to evaluate the safety and tolerability of a single intravenous     dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will     also be evaluated how MEDI-578 is absorbed and distributed through the body.   "
245446|NCT01072604|"     To determine the bioequivalence of new formula of aspirin relative to the established     commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult     subjects   "
245447|NCT01072617|"     The primary aim of this protocol is to determine whether the use of repetitive transcranial     magnetic stimulation (rTMS) over vermis of the cerebellum may be safe and therapeutically     effective in patients with schizophrenia. Because this is the first evaluation of this     treatment in this population, the focus of this study is safety.   "
245448|NCT01072630|"     The primary objective of the study is to determine whether armodafinil treatment, at a dosage     of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood     stabilizers for treatment of adults with major depression associated with bipolar I disorder.   "
245449|NCT01072643|"     Clinical dose escalation drug trial to evaluate the effect of 3 different doses of     dexmedetomidine on the pulmonary vascular bed in pediatric subjects with elevated pulmonary     vascular resistance (PVR). The study will be conducted in 2 parts, with part 1 incorporating     stopping rules to optimize safety of the drug in this population. The second part of this     study will evaluate if the lowest safest dose, as determined in part 1, is adequate to     provide effective sedation during a cardiac catheterization procedure.   "
245450|NCT01072656|"     The purpose of this study is to determine the safety and efficacy of Deep Brian Stimulation     (DBS) of the ventral capsular/ventral striatal as a treatment for patients with Thalamic Pain     Syndrome (TPS). The central hypothesis to be tested in this investigation is that VC/VS     stimulation will modulate the affective component of TPS and, consequently, improve pain     related disability.   "
245451|NCT01072669|"     The purpose of this study is to investigate the effectiveness of a drug called ambrisentan,     approved by the FDA for use in pulmonary hypertension (a condition where there is increased     pressure in the right side of the heart) in scleroderma patients, to see if this medicine may     be beneficial in relieving and/or preventing Raynaud's flares in you and other patients like     you. This medicine may have some short-term and long-term benefits in persons with     scleroderma   "
245452|NCT01072682|"     The purpose of this protocol is to evaluate the safety of a selective cytopheretic device     (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute renal     failure (ARF).   "
245453|NCT01072695|"     This a phase 2, randomized, open-label trial of GS-9256 plus GS-9190, two oral anti HCV     drugs, for 28 days with and without ribavirin (RIBA) and with pegylated interferon (PEG)/RIBA     in adults with chronic Hepatitis C virus (HCV). In Part A, approximately thirty (30) subjects     18-70 years of age who meet study entry criteria will be randomized (in other words, selected     at random, like flipping a coin) to one of the two treatment groups (GS-9256 plus GS-9190 or     GS-9256 plus GS-9190 plus RIBA). In Part B, an additional fifteen (15) subjects will receive     75 mg GS-9256 BID plus 40 mg GS-9190 BID in combination with PEG/RIBA. After the 28-day     treatment period, subjects will receive PEG/RIBA as standard of care (SOC).      Following randomization, subjects will return for a Baseline (Day 1) visit, at which time     study medication will be dispensed and subjects will enter a 28 day treatment phase. During     the treatment phase, subjects will receive oral study drugs twice daily for 28 days and PEG     once weekly for Part B. Subjects then receive PEG/RIBA as local SOC starting on Day 28 (not     provided as part of the study). Following completion of the 28-day treatment phase, subjects     will be followed for approximately 72 weeks.   "
245454|NCT01072708|"     For some years, the investigators observe an increase of the arisen of diabetes in cystic     fibrosis patients However, this diabetes may be reversible. The investigators speak about      Cystic fibrosis related diabetes.. The objective of this project, is to know better what     facilitates the appearance and the reversibility of the diabetes, such as the genetic     mutations, the respiratory state and the lung infections. Theses knowledges should allow to     adapt the screening of diabetes, and its treatment, for the patients affected by cystic     fibrosis.   "
245455|NCT01072721|"     Early diagnosis of liver fibrosis is useful for the follow-up and treatment of chronic liver     disease. At present, the unique validated method to evaluate the liver fibrosis in children,     is the liver biopsy which is an invasive method. If the elastometry method is proved to be a     good method to evaluate the fibrosis in children, a numerous liver biopsy could be avoided.   "
245456|NCT01072734|"     Annual influenza vaccination is recommended in patients with systemic lupus erythematosus     (SLE). However some concerns remain about vaccination and the risk of lupus flare   "
245457|NCT01072747|"     The primary objective of this study is to verify, through a randomized, blinded, parallel     clinical trial, the efficacy of bovine heparin from Bergamo Laboratory ACTIPARIN ® product     when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery     cardiovascular disease and who require cardiopulmonary bypass, through the control of     hemostasis during and after surgery, based on measurements of markers of coagulation ACT,     aPTT, anti-Xa heparin levels and the excessive blood loss (hemorrhage) after the end of     surgery.   "
245458|NCT01072760|"     The objective of this report is to describe a new surgical technique for the treatment of     bony mallet finger which involves the application of both Kirschner wire and pull-out wire     fixation. It is believed to decrease the risk of the complications.   "
245459|NCT01072773|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Giving bortezomib together with combination     chemotherapy may kill more cancer cells.      PURPOSE: This phase II trial is studying how well giving bortezomib, cyclophosphamide, and     dexamethasone together works in treating patients with primary systemic light chain     amyloidosis.   "
245460|NCT01072786|"     Dengue viruses can cause dengue fever and other serious health conditions, primarily     affecting people living in tropical regions of the world. This study will evaluate the safety     and immune responses of five formulations of a tetravalent dengue virus vaccine in healthy     adults.   "
245461|NCT01072799|"     This is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety,     tolerability and immunogenicity of three dose levels (5µg, 15µg and 45µg HA) of the novel A     (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults (18 to 64 years of     age).   "
245462|NCT01072812|"     This trial will determine the pharmacokinetics of Posiphen® in both plasma and CSF after a     10-day treatment period with Posiphen® in subjects with amnestic MCI. The effects of this     treatment on biomarkers will also be determined in CSF, whole blood, and plasma or serum as     primary pharmacodynamic (PD) objectives.   "
245463|NCT01072825|"     The physical and psychological effects of the hormonal treatment of transsexual persons are     not sufficiently described. 'Transparency' wants to answer this question in a prospective     manner, in a multicenter study to describe these effects. The low prevalence of     transsexualism was the stimulus to search for European partners for this Protocol. A common     standardized hormonal protocol was designed.   "
245464|NCT01072838|"     To determine local disease control (recurrence) with shorter course of APBI delivered with a     breast brachytherapy applicator.   "
245465|NCT01072851|"     The objective of this study is to compare the effectiveness of multimedia and print tools     designed to provide patients at safety-net clinics with comprehensible information about     colorectal cancer screening and motivate them to complete screening.The print and multimedia     interventions were constructed with parallel content to allow valid comparison of     format-related effects on knowledge and screening rates.These easy to use tools will provide     under served patients at community health centers with clear and consistent messages about     colorectal Cancer(CRC) and CRC screening, delivered immediately before the patients see a     doctor.      Specific Aims        1. To determine if multimedia and print interventions that provide patients with          information and motivational messages about CRC screening increase screening rates above          usual care.        2. Determine whether showing patients a multimedia program achieves higher CRC screening          rates than does a print booklet with equivalent messages.             1. Examine if the effects of these multimedia and print interventions on CRC screening               rates differ with literacy level.             2. Examine if the effects of these multimedia and print interventions on CRC screening               differ with race/ethnicity             3. Examine if these multimedia and print interventions have differential effects on               knowledge relevant to CRC screening.   "
245466|NCT01072864|"     To determine the potential acute cardiovascular benefits of California Walnuts in     postmenopausal women of ages 55-70.      Primary outcome measures:        -  Vascular function        -  Platelet reactivity      We hypothesize that the consumption of California walnuts will improve vascular function and     platelet reactivity.   "
245467|NCT01072877|"     Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and     may cause discomfort. In this study, patients with varicose veins in the legs will be     participating. The purpose of this research study is to evaluate the safety and effectiveness     of three different concentrations of an investigational drug, polidocanol injectable foam     compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose     veins.   "
245468|NCT01072890|"     The purpose of this study is to test the safety of temsirolimus and pazopanib at different     doses. Patients who have an advanced cancer that is not felt to benefit from standard     treatment or are no longer responding to other treatment will be asked to take part in this     study. The study hypothesis is that temsirolimus and pazopanib can be administered safely in     combination and that combined targeting of the mammalian target of rapamycin (mTOR) and     vascular endothelial growth factor receptor (VEGFR) signaling pathways will be effective in     treating patients with advanced solid tumors.   "
245469|NCT01072903|"     The research project addresses the following hypotheses (A) the normal balance of beneficial     and detrimental commensal intestinal bacteria is deranged in IBS, with selective alterations     in clinically defined patient subsets i.e., diarrhea predominant IBS (D-IBS) and     post-infectious IBS (PI-IBS); (B) these changes in intestinal microflora are associated with     sub-clinical mucosal inflammation and activation of the mucosal immune system; and (C)     activation of the mucosal immune system leads to alterations in gastrointestinal (GI)     functions (i.e., motility and sensation) and functional symptoms.   "
245470|NCT01072916|"     The proposed pilot project for this seed grant focuses on the role of intestinal     serine-proteases in the pathogenesis of diarrhea-predominant IBS (D-IBS). In this study we     will further assess serine-protease activity in patients with D-IBS and also explore a     possible mechanism by which these proteases can lead to alterations in intestinal physiology     and symptoms in these patients.      The general hypotheses for the proposed research are that (A) the levels of fecal     serine-protease in patients with D-IBS are abnormally increased (B) this abnormal     serine-protease activity leads to/is associated with an abnormal increase in intestinal     permeability and therefore enables (C) chronic stimulation and activation of the mucosal     immune system in these patients. In addition, it is aim to determine whither periodontal     inflammation is associated with intestinal permeability and serine protease activity.   "
245471|NCT01072929|"     The primary objective of the study is to determine whether armodafinil treatment, at a dosage     of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood     stabilizers for treatment of adults with major depression associated with bipolar I disorder.   "
245472|NCT01072942|"     The study will be conducted in a single-center, randomized, single-blinded,     placebo-controlled, dose escalation design with two dose groups.Multiple-dose inhalation of     Ciprofloxacin inhale 50 and 75 mg or placebo will be administered to 16 Japanese patients     with COPD in totalPatients with moderate to severe COPD, stage II or III according to GOLD     criteria, will participate in the study.The study will consist of 2 steps as indicated below;     starting at Step 1 (50 mg) and escalating doses up to Step 2 (75 mg), after the tolerability     of the dose in the previous step is confirmed. In each step, the study will be conducted as     multiple dose study with b.i.d. regimen for 10 days (between day 2 and 11) in a randomized,     single-blind, placebo-controlled design. In addition, before and after the multiple dose     administration, single administration will be conducted in each subject (day 0 and 12).   "
245486|NCT01073124|"     The purpose of this study is to determine if adding blue dye improves the saline load test,     which is a way to detect a traumatic intraarticular knee injury by injecting normal saline     into the knee and looking for outflow through the wound.   "
245473|NCT01072955|"     The primary objective of this study is to verify, through a randomized, blinded, parallel     clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory product when     compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular     disease and who require cardiopulmonary bypass, through the control of hemostasis during and     after surgery, based on measurements of markers of coagulation ACT, aPTT, anti-Xa heparin     levels and the excessive blood loss (hemorrhage) after the end of surgery.   "
245474|NCT01072968|"     Multicenter randomized double blind study versus placebo during 12 weeks with at first, an     escalating dose period followed by stable dose period at the selected dose.      This double-blind period can be followed by a 9 months open-label period if the patient     wishes to continue with the study product.   "
245475|NCT01072981|"     The purpose of this study is to assess overall survival after treatment with a regimen of     adjuvant therapy (Gemcitabine alone or with 5-FU chemoradiation) with or without     HyperAcute®-Pancreas (algenpantucel-L) immunotherapy in subjects who have undergone surgical     resection.   "
245476|NCT01072994|"     Despite aggressive treatment, patients with heart failure have a poor prognosis.     Docosahexaenoic acid (DHA), an omega-3 polyunsaturated fatty acids found in fish oils, may     prevent the progressions of heart failure through mechanisms that are not addressed with     current drugs.      The omega-3 polyunsaturated fatty acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic acid     (EPA) favorably impact mitochondrial dysfunction and chronic inflammation in heart failure     (HF). Treatment with DHA-t-EPA alters cardiac phospholipid composition by decreasing     arachidonic acid (a pro-inflammatory fatty acid) and increasing DHA and the mitochondrial     phospholipid cardiolipin, with is associated with improved Left Ventricular (LV) function.      Fish oil supplements contain a mix of DHA and EPA, however we postulate that DHA is superior     to EPA in improving mitochondrial function and suppressing inflammation, and thus DHA should     be used to treat HF.      Cardiac phospholipid fatty acid composition (i.e. DHA, EPA, and arachidonic acid) and     cardiolipin (CL) content will be measured in biopsies from stable heart transplantation     patients that are obtained as part of standard clinical care in heart transplant patients     before and after treatment with DHA alone or DHA+EPA. We will compare cardiac phospholipid     composition from biopsies obtained at study entry and at 6 months follow-up (allowable range     +/- two months, depending on patients' clinical conditions).   "
245477|NCT01073007|"     The purpose of this study is to determine whether simvastatin treatment started within the     first 12 hours from stroke onset improves neurological and functional outcomes, evaluated at     seventh day/discharge or at the third month.      Also, to demonstrate that simvastatin is safe and not associated with higher rates of     hemorrhagic transformation in patients who receive thrombolysis.   "
245809|NCT01067170|"     This study aims to determine the effect of pneumatic compression devices (PCDs) on central     blood volume in hemodialysis patients. We hypothesize that PCDs will help maintain central     blood volume, and therefore prevent sudden decreases in blood pressure during hemodialysis.   "
245478|NCT01073020|"     There is substantial clinical evidence regarding the safety and efficacy of currently     practiced bariatric surgical techniques to improve metabolic control and/or resolve type 2     diabetes (T2DM) in clinically severe obese patients (class 3 obesity). Evidence suggests such     procedures have greater effects on insulin secretion and insulin action than that expected     from weight loss alone, which has led to the recent claim that such procedures may be useful     as a primary treatment for T2DM in the moderately obese population. Concurrently, there have     also been substantial advances in the non-surgical medical management of T2DM. As a result,     the best treatment algorithm for T2DM patients with class 1 & 2 obesity is increasingly     controversial. This trial investigates the utility of currently practiced and available     bariatric surgical procedures as compared with multidisciplinary intensive medical and weight     management for the treatment of T2DM with class 1 and 2 obesity.   "
245479|NCT01073033|"     To assess protection against early life infections through supplementation of mothers during     pregnancy to the newborns' growth, morbidity, immune status intra and extra-uterine.   "
245480|NCT01073046|"     The purpose of this study is to test the utility of the nasogastric tube, which is used to     decompress and as guardian of gastro-jejunal anastomosis, in patients undergoing distal     subtotal gastrectomy for gastric cancer with reconstruction according to Billroth II or     according Roux.   "
245481|NCT01073059|"     -  This trial is conducted to assess pharmacokinetic characteristics of valproic acid when          valproic acid single treatment and valproic acid & ertapenem combination treatment        -  This trial is performed to evaluate safety of the combination treatment compare with          single treatment        -  The investigators carry this trial out to study mechanism of combination treatment   "
245482|NCT01073072|"     This is a multicentric prospective randomized study comparing technique of tension-free     repair with placement of a bovine pericardium bioprosthesis (Tutopatch® and Tutomesh®) to     current conventional surgical techniques in potentially contaminated hernia repair and     abdominal wall reconstruction.      The hypothesis is that using Tutomesh® prostheses reduces the risk of postoperative     complications at 30 days in the treatment of incisional hernias or complicated abdominal wall     hernias (ref early complications) for potentially contaminated fields.   "
245483|NCT01073085|"     The purpose of this study is to investigate the effectiveness of a French fully automated     web-based smoking cessation program known as the coaching, by comparing it to an online     self-help guide.   "
245484|NCT01073098|"     Out of hospital cardiac arrest is a major health problem. Prognosis is still poor even after     return to spontaneous circulation. The pathophysiology of cardiac arrest implies     ischemia-reperfusion and sepsis like syndrome. These phenomenons can lead to microvascular     dysfunction explaining probably multi-organ failure after cardiac arrest. Few means allow the     exploration of microvascular function in human. Muscle StO2 is a technique allowing the     assessment of microvascular function non-invasively. The aim of this study is to evaluate     muscle StO2 as a prognostic factor after out of hospital cardiac arrest.   "
245485|NCT01073111|"     The purpose of this study is to compare coronary endothelium function in patients with a     zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical     coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker     level.   "
245487|NCT01073137|"     The purpose of the research is to determine whether a noninvasive hearing test may be used to     predict blood glucose in people with diabetes.   "
245490|NCT01073176|"     Training Executive, Attention and Motor Skills (TEAMS) is a new research program for     preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use     game-like activities and physical exercise to promote the growth of neural processes that     underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as     associated areas of difficulty (e.g., socialization, motor skills). These activities are     implemented at home and in supervised playgroups at no cost to families and are coupled with     extensive parental education about ADHD symptoms and associated impairments.   "
245491|NCT01073189|"     Randomized prospective trial of patients with diuretic unresponsive acute kidney injury where     patients will receive standard supportive therapy with diuretics versus intra-renal delivery     of the vasodilator fenoldopam mesylate.      Patients with rising creatinine who fail to respond to bolus diuretics will be treated with a     prolonged course of diuretics or undergo placement of a catheter within the renal arteries     that allows for infusion of fenoldopam mesylate. The rational is that early delivery of a     high dose vasodilator may reverse the decline of renal function in patients with severe acute     kidney injury.   "
245501|NCT01062958|"     This study is a multi-site, retrospective chart review to determine the effect of Neevo® or     Neevo®DHA (with higher folate and B12) versus standard prenatal vitamins on hemoglobin (Hgb)     levels in pregnant women throughout the course of pregnancy. Neevo® is a prescription medical     food indicated for the dietary management of women under a doctor's care who face high risk     pregnancies, older overactive bladder (OB) patients and patients unable to fully metabolize     folic acid. Data will be collected from existing patient charts of subjects administered     Neevo® or Neevo®DHA daily compared to subjects administered a prenatal vitamin daily.   "
245502|NCT01062971|"     To compare intraocular pressure lowering effectiveness of a new fixed combination drug.   "
245517|NCT01063166|"     The Computer-Assisted Self-administration of Ethanol (CASE)will be administered twice, at the     ages 18 and 20, in a prospective study of 80 adolescents living in the Dresden area. The     sample will be recruited for a differential family history of alcoholism (FHA) and gender,     with inventories of alcohol use disorder (AUD) symptoms and personal recent drinking history     (RDH) obtained prior to each CASE session.   "
245492|NCT01062841|"     This is an interventional study aimed at reducing multi-drug resistance and infections in     nursing home (NH) residents. Each year, a staggering 1.5-2.0 million infections occur in NHs.     Many of these infections are caused by multiple drug resistant organisms (MDROs) including     methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE),     and multidrug resistant Gram-negative bacilli (R-GNB). Antimicrobial resistance among common     bacteria are adversely affecting the clinical course and exponentially increasing healthcare     costs. Recognizing a need for action, legislators, policy makers, and consumer groups are     advocating for pathogen-based universal preemptive screening for these MDROs, particularly     MRSA in hospitals and NHs. However, implementing this sweeping mandate is controversial,     costly, reactive, and not based on empirical evidence. It can result in a 10-20-fold increase     in the number of NH residents placed in isolation precautions with the potential for reduced     attention by healthcare workers, isolation and functional decline. The investigators proposal     evaluates a novel focused approach between 'do nothing' and 'search all and destroy'     strategies by targeting a subgroup of NH residents with indwelling devices who are at a high     risk of acquiring MDROs and infections.      The investigators hypothesize that the investigators targeted infection control program (TIP)     will reduce MDRO colonization and infections in NH residents with indwelling devices. This     cluster randomized trial will involve 12 NHs; 6 will be randomized to the TIP arm and 6 to     the routine care arm. The investigators TIP intervention will include four components.   "
245493|NCT01062854|"     The main goal of this study is to assess whether use of earplugs has any effect on sleep,     sleep apnea, and daytime sleepiness in individuals who snore.   "
245494|NCT01062867|"     Title: First administration to man of Org 25435, a new intravenous anaesthetic.      Protocol: 12.4.104      Clinical Phase: Phase I      Study Site:      Phase I Clinical Trials Unit Ltd Old Convent of Notre Dame 119 Looseleigh Lane Plymouth PL6     5HH United Kingdom      Objectives: To assess the safety, tolerability, preliminary pharmacokinetics and efficacy of     Org 25435 as an intravenous anaesthetic.      Study Design: Sequential study of an intravenous anaesthetic in young healthy males, at up to     eight dose levels.      Study Drug: Org 25435, a water soluble intravenous anaesthetic.      Subjects: Up to 47 healthy male volunteers, aged 18-40 years.      Evaluations: Tolerability, adverse events, EEG effects, cardiovascular effects,     electrocardiogram (ECG), excitatory phenomena, respiratory effects, laboratory safety blood     analyses, pharmacodynamic and pharmacokinetic measurements.   "
245495|NCT01062880|"     Neuropattern is a first translational tool in stress medicine. Neuropattern is a diagnostic     tool, which can be applied by in- and outpatients and physicians to detect dysregulation in     the stress response network. The physician provides anamnestic and anthropometric data, while     the patient takes other measures at home, e.g. psychological, symptomatic, and biological     data. Among the biological data are ECG measures for analyses of heart rate variability, and     salivary cortisol measures before and after a dexamethasone challenge test. All data are     analyzed in a central laboratory, which generates a written report for the physician,     including a disease model, from which personalized recommendations for pharmacological and     psychological treatments are derived. Neuropattern additionally offers individualized     internet modules to inform the patient about the disease model and to teach him/her what     he/she can do to improve his/her medical conditions. The current study applies Neuropattern     in 2000 patients of family doctors, suffering from major depression, depressive episodes,     adjustment disorders, and somatoform disorders. The patients receive either unspecific or     individualized internet modules in a randomized order.   "
245496|NCT01062893|"     An attempt is being made to see if by injecting a set volume of sterile saline into the     epidural space during the treatment of labor pain with a combined spinal/epidural (CSE)     increases the amount of pain relief obtained and makes the labor analgesia lasts longer.     Subjects are in the study from the time their CSE is placed until they request additional     pain medication from the spinal dose of numbing medicine wearing off.   "
245633|NCT01064674|"     Due to rising importance of cardiovascular disease before and after renal transplantation we     have changed our standard diagnostic procedure and perform stress echocardiography and     myocardial scintigraphy. We would like to monitor these results and the outcome of our     patients.   "
245497|NCT01062906|"     Intravenous lidocaine has been shown to have analgesic, antinflammatory, antihyperalgesic,     antithrombotics and neuroprotective properties. In a previous study conducted in patients     undergoing laparoscopic cholecystectomy under general anesthesia with desflurane and     fentanyl, intraoperative i.v. infusion of lidocaine spared opioids consumption in the     recovery room by 30%.      The purpose of this study was to determine if an i.v. infusion of lidocaine without     intraoperative opioids would reduce the amount of fentanyl to the same extent and     opioids-related side effects.   "
245498|NCT01062919|"     This is a double blinded randomized controlled trial in patients undergoing colon open     surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques     on functional recovery after surgery.      Twenty five patients will receive thoracic epidural analgesia plus patient controlled     analgesia (PCA) (epidural analgesia group) and 25 patients wound infiltration of local     anesthetic plus PCA (wound infusion group).      Hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion     will be faster than patients receiving thoracic epidural analgesia.      Functional recovery, pain intensity, opioid consumption and side effects, length of hospital     stay and biological markers of inflammation after surgery will be measured in both groups.   "
245499|NCT01062932|"     Psychosocial treatments for drug abuse benefit some patients (Rawson et al 2004), but there     is an urgent need for new treatment approaches that can improve treatment outcomes. One new     approach involves facilitation of extinction of conditioned responses through the use of     d-cycloserine, a partial agonist at the NMDA glycine site. This approach has proved useful     for the treatment of several anxiety disorders. For example, treatment with d-cycloserine     enhanced the efficacy of behavioral treatments for acrophobia (Ressler et al 2004) and social     phobia (Hofmann et al 2006) by enhancing extinction of conditioned fear responses. This     suggests that d-cycloserine has potential to enhance the efficacy of behavioral treatments     for drug dependence by enhancing extinction of conditioned responses to drug cues. In this     Phase I Cutting-Edge Basic Research Awards (CEBRA) application we propose a proof-of-concept     study to examine effects of treatment with d-cycloserine for facilitating extinction of     craving provoked by exposure to cigarette smoking cues. The benefits of this treatment     approach together with cognitive behavioral treatment for reducing cigarette smoking will     then be determined. Smoking cues will be presented using an established virtual reality     simulator(Bordnick et al 2004; Bordnick et al 2005a)   "
245503|NCT01062984|"     Acute kidney injury is often treated with the use of continuous renal replacement therapy.     Two commonly used treatments are continuous venvenous hemofiltration (CVVH)and continuous     venovenous hemodialysis (CVVHD). CVVH uses convective clearance to remove toxins and solutes     from the patients circulation, while CVVHD relies on diffusive clearance to remove these same     toxins/solutes. This study will evaluate which of these two methods is more effective at     clearing the body of waste/solutes.      We hypothesize that renal replacement therapy by either modality (hemodialysis or     hemofiltration; CVVHD or CVVH, respectively) using a modern membrane and higher blood flow     rates will be associated with similar clearances of both small and middle molecular weight     solutes. We further believe that continuous renal replacement therapy using CVVHD will be     associated with decreased clotting events and longer hemofilter survival, as well as improved     resource utilization (i.e. nursing time, alarms, etc.).   "
245504|NCT01062997|"     A randomized, prospective comparison of volar locked plating versus Hoffman II bridging     external fixation supplemented by K-wire fixation in patients with comminuted distal radius     fractures, AO/OTA type C2 & C3.      Hypothesis:      There is no significant difference in using volar plates compared to Hoffman II bridging     external fixation supplemented by K-wire fixation in patients with comminuted distal radius     fractures, AO/OTA type C2 & C3 as evaluated by a Quick-DASH score at 24 months follow-up.   "
245505|NCT01063010|"     The purpose of this study is to perform a pilot study to assess the potential use of     Bevacizumab (a vascular endothelial growth factor (VEGF) inhibitor) in sepsis.   "
245506|NCT01063023|"     To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and     norelgestromin (NGMN) in healthy female subjects   "
245507|NCT01063036|"     The purpose of this study is to show that the combination of entecavir and tenofovir, is     effective and well tolerated in chronic hepatitis B patients who have failed previous     treatment.   "
245508|NCT01063049|"     The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax     combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl     may also be used with the Gatorade and Miralax to see if it helps with the clean out process.     We are trying to find out if either of these methods is more acceptable to the patient and     does a better job cleaning out the colon for a colonoscopy.   "
245509|NCT01063062|"     This single-arm, open-label, multicenter study evaluated the safety and tolerability and the     efficacy in reducing disease activity of tocilizumab [RoActemra/Actemra] as monotherapy or in     combination with methotrexate in patients with active moderate to severe rheumatoid arthritis     (RA). Patients were eligible to participate in this study if they are currently experiencing     an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic     drug (DMARD). Patients received 8 mg/kg tocilizumab [RoActemra/Actemra] as an intravenous     infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment     was 24 weeks. The target sample size was 50-200 patients.   "
245510|NCT01063075|"     The primary purpose of this study is to help answer the following research question(s):        -  To see how the body absorbs, processes, and gets rid of cetuximab when the drug is taken          in combination with carboplatin [pharmacokinetic (PK) analysis]        -  To see if any drug interactions occur between cetuximab and carboplatin.   "
245511|NCT01063088|"     The purpose of the study is to verify the safety and immunogenicity of a trivalent seasonal     influenza vaccine with strain composition according to World Health Organization     (WHO)/European Union (EU) recommendation for the 2009/2010 season.   "
245512|NCT01063101|"     The purpose of the study is to investigate whether orally administered BAX 513 (different     doses administered for 5 days) affects hemostatic parameters in healthy volunteers.   "
245556|NCT01063673|"     Running patterns are thought to have a major influence on the development of Running Related     Injuries (RRI), however to studies have documented such relationship. Thus, the aim of the     study is to investigate the association between running patterns and overuse injuries in     runners.   "
245513|NCT01063114|"     There are two types of external radiation treatments (proton beam and photon beam). As part     of the participant's treatment, they will receive radiation to the entire central nervous     system (CNS); this is known as craniospinal irradiation (CSI). In the past, photon radiation     therapy has been used for CSI. In this study we will be examining the effects of proton beam     radiation therapy. Studies have suggested that this kind of radiation can cause less damage     to normal tissue than photon radiation therapy. The physical characteristics of proton beam     radiation let the doctor safely deliver the amount of radiation delivered to the tumor that     is normally delivered through standard therapy but spare more normal tissue in the process.   "
245514|NCT01063127|"     The purpose of this study is to quantify the relative contribution of improved insulin     sensitivity and improved insulin secretion to the glycaemic effect of bariatric surgery.   "
245515|NCT01063140|"     Rabies immune globulin is a product that is lifesaving to unvaccinated individuals exposed to     the rabies virus. Rabies immune globulin is made from plasma from immune donors. Currently     the only practical method to obtain this plasma is to immunize normal volunteer Source Plasma     donors and collect their plasma while titers are adequate. The use of rabies vaccine for     immunization of normal Source Plasma donors is currently limited to a level that, while     protective for the individual, is unsuitable for production of rabies immune globulin.      The objective of this study is to obtain efficacy and safety data regarding the rabies     boostering program to demonstrate that:        1. Rabies immune plasma production can be substantially increased by giving booster doses          to previously immunized donors whose titers are below 10.0 IU/mL.        2. It is safe for normal Source Plasma donors to receive booster doses of rabies vaccine on          a regular basis.      This study utilizes two rabies vaccines approved by the FDA, Imovax® (Sanofi-Pasteur) and     RabAvert® (Novartis).   "
245516|NCT01063153|"     The purpose of this research study is to study a device called an electroencephalograph (EEG)     in the diagnosis of treatment of attention deficit hyperactivity disorder (ADHD) in adults.     People with ADHD have symptoms such as difficulty sustaining attention, organizing, and     managing impulsivity. They can have trouble in school, at work, and at home. Subjects with     ADHD who participate in this study will be given a once daily stimulant medication called     osmotic release methylphenidate (Concerta) for 6 weeks, and have EEG testing done before and     after the treatment period. Subjects will perform a computer based cognitive task during EEG     testing. The U.S. Food and Drug Administration has approved osmotic release methylphenidate     (Concerta) for the treatment of ADHD in adults and children. Similar procedures, without     medication, will be performed with a sample of healthy adults without ADHD.   "
245519|NCT01063192|"     The primary end point is to evaluate the time to progression after gemcitabine alone versus     Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy     in locally advanced pancreatic cancer.      The secondary end points are to evaluate the disease control rate, overall survival time,     toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy     as well as the disease control rate after inductional chemotherapy alone in locally advanced     pancreatic cancer. Translational research including pharmacogenomic study and biomarker study     will also be done concomitantly.   "
245520|NCT01063205|"     The purpose of this study is to determine the effects of treatment with NAC, compared to     treatment with placebo, on cue- and methamphetamine (MA)-induced craving and MA subjective     effects in non-treatment-seeking MA-dependent human volunteers. We also aim to determine the     effects of treatment with NAC, compared to treatment with placebo, on the reinforcing effects     of MA by measuring MA self-administration in non-treatment-seeking MA-dependent human     volunteers.   "
245521|NCT01063218|"     The main goal of this present study is evaluate the decreasing of necessity of topic     corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the     correct emollients.   "
245522|NCT01063231|"     Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to     conventional colonoscopy.   "
245523|NCT01063244|"     We will compare the use of foley bulb catheters placed in the cervix for ripening of the     cervix for labor induction,.   "
245524|NCT01063257|"     This study aims to determine the maximal tolerated dose (MTD) and dose limiting toxicities     (DLTs) of low dose IV clofarabine for MDS patients after treatment failure of azacitidine.   "
245525|NCT01063270|"     The purpose of this research study is to further evaluate the efficacy of two treatment     regimens for the treatment of hidradenitis suppurativa. This is a randomized controlled     study. Patients will be randomly assigned to an arm of the study.   "
245526|NCT01063283|"     The purpose of this study is to see if higher dose of bevacizumab can be taken safely by some     patients and if changes in the dose of bevacizumab have any effect on blood pressure.   "
245527|NCT01063296|"     Cervical cancer is a major health problem for Chinese women. It is estimated that nearly     100,000 new cervical cancer cases occur in China every year, which accounts for about 20     percent of global new cases. Surgery and radiotherapy are two major radical treatment methods     for IB-IIB cervical cancer. Unlike the United States and some other countries, most of     operable women with IB-IIB cervical cancer received radical surgery other than radiotherapy     in China. Patients with recurrence risk factors (lymph node metastasis, deep stromal     invasion, positive lymphatic vascular space, et al. ) also received adjuvant therapy after     surgery, such as radiotherapy or chemoradiotherapy that are recommended in the NCCN     guidelines. However, in China a substantial part of patients especially those admitted to     tertiary hospitals received several courses of chemotherapy instead of radiotherapy if they     had recurrence risk factors .      In our previous study, we found that patients with intermediate risk factors (deep stromal     invasion, positive lymphatic vascular space, bulky tumor>4cm) had better disease-free     survival and recurrence-free survival when they received chemotherapy compared with     radiotherapy. The objective in this study is to investigate whether the advantage of     postoperative chemotherapy is a result of circulating tumor cells (CTC) in some of the     patients with intermediate risk factors.   "
245558|NCT01063699|"     This study evaluated laparoscopic (videosurgery) versus conventional (open surgery) Kasai     portoenterostomy (anastomosis of small intestine to the liver hilus) in children with biliary     atresia. The study was stopped due to lower survival with native liver 6 months after the     laparoscopic operation. Follow-up after 24 months confirmed superior results after     conventional operation.   "
245528|NCT01063309|"     Background:        -  Atherosclerosis, the arterial plaques or blockages that cause heart disease, develops in          many people by the time they are in their mid-20s. The rate of atherosclerosis in          patients with immune system disorders has not been well studied, but it may be very          different from the general population.        -  Patients with chronic granulomatous disease (CGD) produce less of a group of molecules          known as free radicals, which help to fight infection and may play a role in the          development of atherosclerosis. Patients with CGD may develop atherosclerosis much more          slowly than people without CGD. On the other hand, carrier mothers of children with          genetically-linked CGD often have problems with autoimmune problems in addition to a          problem with making free radicals. Patients with other immune system disorders also have          very different responses to infection, and many of them also have autoimmune-like          problems that may change the risk of developing atherosclerosis.      Objectives:      - To study the prevalence of atherosclerosis in patients with immune system disorders,     compared with healthy individuals.      Eligibility:      - Individuals at least 18 years of age who either have been diagnosed with an immune system     disorder or are healthy volunteers.      Design:        -  The active part of the study involves one or two visits to the National Institutes of          Health Clinical Center for a series of imaging tests and scans.        -  Participants will have the following tests during the active part of the study:        -  (1) CAT scan to obtain images of the chest arteries and measure the amount of calcium in          the artery walls.        -  (2) Magnetic resonance imaging scan to obtain images of the coronary and carotid          arteries in the chest and neck.        -  (3) Electrocardiogram to provide data on current heart function.        -  (4) Blood samples to provide data on heart, kidney, and immune system function.        -  Participants will be contacted every 2 years in the future for up to 30 years to          determine whether they have developed heart disease. Researchers will ask participants          to provide contact information for two other people who may likely know how to get in          touch with the participant in the future.   "
245529|NCT01063322|"     Background:      - Mitral regurgitation, or leaking of the mitral heart valve, is usually studied and assessed     with an ultrasound test called a two-dimensional (2D) echocardiogram. While this test has     proved very useful, technological improvements have helped researchers develop ways to study     the heart valves using imaging with three-dimensional (3D) capabilities. In addition,     recently developed magnetic resonance imaging (MRI) techniques may be able to provide better     information about the causes and severity of the leak. Researchers are interested in testing     these new techniques to determine their usefulness for patients with mitral regurgitation.      Objectives:      - To evaluate newer methods of studying mitral regurgitation severity using real-time 3D     echocardiography (RT3DE) and cardiac magnetic resonance imaging (CMRI).      Eligibility:      - Individuals at least 21 years of age who have been diagnosed with more than mild mitral     regurgitation.      Design:        -  Participants will have two procedures as part of this study: an echocardiogram and an          MRI scan.        -  For the echocardiogram, participants will have an ultrasound scan with a special kind of          probe. Participants may also receive an injection of a contrast agent to provide a          better image of the heart on the scan. The scan will take approximately 1 hour to          complete.        -  For the MRI scan, participants will have a standard MRI with special pads placed on the          chest to provide better imaging of the heart. The scan will usually take between 45 and          90 minutes to complete.   "
245627|NCT01064596|"     After bariatric surgery , thromboembolics complications are major cause of mortality.     However, in obese patients, thromboprophylaxia is a controversy. Fondaparinux' efficacy is     superior to HBPM, and is a good treatment for this population. Pharmacokinetics information     with Fondaparinux in this population are rare.   "
245530|NCT01063335|"     Background:      - The CB1 receptor is a protein in the brain that is targeted by the active ingredients in     cannabis (marijuana). Brain systems that react to cannabis may be involved in the causes and     symptoms of schizophrenia and schizoaffective disorder. For instance, research studies have     shown that the number of CB1 receptors may be different in people with schizophrenia, and     there may be differences in the receptors themselves. Researchers are interested in using     positron emission tomography (PET) to study CB1 receptors in people with and without     schizophrenia, using a chemical tracer that attaches specifically to CB1 receptors.      Objectives:      - To determine whether the CB1 receptor brain protein is different in people with and without     schizophrenia.      Eligibility:      - Individuals between 18 and 55 years of age who either have been diagnosed with     schizophrenia/schizoaffective disorder or are healthy volunteers.      Design:        -  Participants in the study must have previously enrolled in the National Institute of          Mental Health protocol A Neurobiological Investigation of Patients with Schizophrenia          Spectrum Disorders and Their Siblings (95-M-0150).        -  Participants will provide blood samples to test for the gene that contains information          on the specific type of CB1 receptor each participant has.        -  Participants will have a PET scan and/or a magnetic resonance imaging (MRI) scan.        -  The PET scan will last approximately 2 hours. Participants will receive an injection of          a small amount of chemical tracer to improve the quality of the images taken during the          scan.        -  The MRI scan will last approximately 1 hour.   "
245531|NCT01063348|"     The goal of the proposed study is to evaluate the comparative efficacy of N-acetyl cysteine     to placebo in pathologic skin picking. Thirty subjects with pathologic skin picking will     receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The     hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in     patients with pathologic skin picking. The proposed study will provide needed data on the     treatment of an often disabling disorder that currently lacks a clearly effective treatment.   "
245532|NCT01063361|"     Healthy individuals with type 2 diabetes will receive intensive counseling on food selection     to improve glucose control using either high cereal fiber dietary strategies or low glycemic     index foods emphasizing dried legumes and their products. The treatments will last 3 months     with bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for     either or both diets, then use of high fiber and/or low glycemic index foods in the diet may     provide another potential way to improve glucose control and lower cholesterol levels in     non-insulin dependent diabetes.   "
245533|NCT01063374|"     A low glycemic index diet may improve glycemic control and reduce plaque buildup in arteries     of those with type 2 diabetes. Subjects will be randomly assigned to receive dietary advice     on either a low glycemic index diet, or a high cereal fibre diet, for three years.   "
245557|NCT01063686|"     Early preterm premature rupture of membranes (PPROM) complicates 0.7% of pregnancies. When     PPROM occurs before the 24th week,the risk of fetal and neonatal death is 70%. There is also     a high risk of neonatal and maternal morbidity. When the diagnosis of PPROM is uncertain by     physical examination, additional tests are needed. These tests have false positive and false     negative rates. The gold standard for diagnosing PPROM is amniocentesis and dye test. This     procedure has a risk of infection and abortion.Our hypothesis is that by using a cervical cap     for 6 hours and repeated ultrasound exams we can diagnose or rule out PPROM in cases which     are uncertain. Our study group will be pregnant women gestational age 14-23, suspected of     having PPROM.   "
245534|NCT01063387|"     This study is an open-label, randomized study, which is designed to investigate the efficacy     of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node     (PAN) and supraclavicular lymph nodes, and also on improving disease-free survival of locally     advanced uterine cervical cancer. This study includes a translational research component in     that all the primary tumors and lymph node are stained with Sema4c, before randomization.     According to the investigators study result, patients with more pelvic lymph node metastasis     are more likely to develop distant metastasis including the recurrences at PAN and     supraclavicular lymph node. Primary cervical cancer tissues and lymph nodes are examined for     expression of Sema4c just after registration, and before the patients are randomized to each     arm (pelvis only vs. EFI). The investigators expect a higher benefit of EFI in patients with     Sema4c-positive lymph node.   "
245535|NCT01063400|"     The purpose of this research is to examine the relationship between performance status rating     and the actual amount of physical activity a subject does when it is measured by an activity     monitor.   "
245536|NCT01063413|"     The purpose of this study is to compare the effect of two after-school programs on children's     physical activity, fitness, body composition, and academic performance.   "
245537|NCT01063426|"     Reload of high dose statin may have potential for preventing deep vein thrombosis (DVT) in     patients on statin undergoing total knee replacement arthroplasty.      A body of evidence have been reported that reloading of atorvastatin have efficacy in     reducing periprocedural myocardial infarction and contrast induced nephropathy. These effects     are considered to be mainly due to their antioxidant anti-thrombotic and anti-inflammatory     property.      We, therefore, hypothesize that high dose atorvastatin re-loading may prevent DVT.   "
245538|NCT01063439|"     The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide,     cytarabine and melphalan (BuEAM) including intravenous busulfan instead of BCNU of standard     BEAM as a conditioning for autologous stem cell transplantation in patients with NHL.   "
245539|NCT01063452|"     The primary objective of this study is to evaluate the impact of the Atkinson Product Design     urinary slide valve on patient morbidity and freedom as measured by impact on activities of     daily living (ADL) and quality of life (QOL). Secondary objectives include assessing the     impact of the device on bacteruria and evaluating the impact of the primary treatment on ADL     and QOL.   "
245540|NCT01063465|"     The purpose of this study is to measure the mechanical properties of healing Achilles tendons     in humans after early controlled weightbearing, compared with a control group in a     randomized, single-blinded trial. The mechanical properties are measured using     radiostereophotogrammetic x-rays (RSA).      Hypothesis: Early weightbearing improves mechanical properties of the healing Achilles     tendon.   "
245541|NCT01063478|"     The purpose of this study is to understand the effects (good and/or bad) of the addition of     RAD001 to standard radiation and chemotherapy (cisplatin and pemetrexed) for patients with     non-small cell lung cancer.   "
245577|NCT01063946|"     Primary Objectives:        -  To determine the excretion balance and systemic exposure of radioactivity after          intravenous infusion of [14C]-AVE8062 to humans        -  To determine the pharmacokinetics of AVE8062 and RPR258063 and their contribution to          overall exposure        -  To collect samples to determine the metabolic pathways of AVE8062 and identify the          chemical structures of the main metabolites      Secondary Objective:        -  To assess the safety profile of the drug   "
245662|NCT01065051|"     The aim of this study is to assess whether oral Riociguat affects the left ventricular     contractility and relaxation in patients with pulmonary hypertension associated with left     ventricular systolic dysfunction   "
245542|NCT01063491|"     Aortocoronary bypass graft failure is common and is associated with high morbidity and     mortality. Failure of saphenous vein grafts is more common than failure of internal mammary     artery grafts. Whether early graft angiography can reduce bypass graft failure remains     unknown. The Cardiac CAtheterization for Bypass Graft Patency Rate Optimization (CABG-PRO)     randomized-controlled pilot study is a phase III, double-blind, randomized-controlled pilot     trial that will randomize 170 patients undergoing coronary artery bypass graft surgery to     early (before dismissal) graft angiography vs. no early graft angiography. Coronary     angiography will be performed at 12 months, to determine whether compared to no early graft     angiography, early graft angiography will result in:        1. lower per patient angiographic bypass graft failure (in at least one graft) rates          (defined as ≥75% diameter stenosis in at least one bypass graft) (primary efficacy          endpoint)        2. lower per graft failure rates, per graft occlusion rates, and per patient bypass graft          occlusion rates (in at least one bypass graft) (secondary endpoints)        3. lower incidence major adverse cardiac events (death, nonfatal myocardial infarction,          nonfatal stroke, coronary revascularization, and composite of death/myocardial          infarction) (secondary endpoint)      Intravascular ultrasonography and near-infrared spectroscopy will also be performed in at     least one bypass graft at baseline (in the early graft angiography group only) and at     12-month angiographic follow-up to evaluate the structural bypass graft changes occurring     after coronary artery bypass graft surgery (secondary endpoint).   "
245543|NCT01063504|"     The investigators will study how well knee joint prostheses become fixed to the bone when     patients get teriparatide, compared to placebo. Measurements will use high resolution 3D     radiography (radiostereometry, RSA).   "
245544|NCT01063517|"     To assess the efficacy of olaparib when given in combination with paclitaxel compared with     paclitaxel alone as defined by progression-free survival (PFS), in all patients with     recurrent and metastatic gastric cancer who progress following first-line therapy   "
245545|NCT01063530|"     The purpose of the study is to confirm the clinical effectiveness and safety of topical     diammine silver fluoride (DASF) as a tooth desensitizer in adulst by comparing it to the     application of sterile water.      The study will be conducted in two different sites in Peru. Participantes will be 144 adults     who will have at least one vital maxillary or mandibular cuspid or premolar with a cervical     defect on the buccal surface and clinical hypersensitivity in response to air. Subjects will     be randomly assigned to a topical application of DAS or sterile water.      The reduction of pain (sensitivity) using a 100 mm VAS, will be determined. Safety will be     also determined by evaluating the gingival condition (erythema, white changes, ulceration,     staining) before and ater the application of the products. The evaluation times will be 24     hours and 7 days.   "
245546|NCT01063543|"     Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A     population pharmacokinetic model of fondaparinux, based on data obtained in patients included     in phase II/III trials, has been described. However, the validity of this model in everyday     practice needed to be confirmed. This study was a multicenter, prospective cohort study in     consecutive orthopedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were     recorded in 809 patients. Population parameters and inter-individual variability were     estimated using NONMEM VI software. A two-compartment model with first-order absorption best     described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual     variability were body weight, age and creatinine clearance estimated by the simplified     Modification of Diet in Renal Disease formula. A body weight less than 50 kg and moderate     renal failure increased drug exposure. These results suggest that fondaparinux     pharmacokinetics need to be confirmed in patient populations not fully assessed in phase     II/III studies   "
245547|NCT01063556|"     The purpose of this study is to investigate the pharmacokinetics of donepezil HCl 3 mg in     subjects with end-state renal disease who were receiving haemodialysis.   "
245548|NCT01063569|"     Addison's disease is a rare condition which in most cases is caused by autoimmune destruction     of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens.     Unrecognized the disease is life threatening, but with proper treatment patients can live     near normal lives.      The conventional glucocorticoid replacement therapy renders the cortisol levels     unphysiological, which may cause symptoms and long-term complications. Glucocorticoid     replacement therapy is technically feasible by continuous subcutaneous hydrocortisone     infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This study aims to further     evaluate CSHI treatment in terms of metabolic effects, effects on health-related     quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover     design.   "
245549|NCT01063582|"     Study of noise generated by military-type aircraft and equipment maintenance in relation to     non-auditory effects that impact with the body of the crew and ground staff can cause cardiac     pathologies      Hypothesis of work: The pilots and the technical personnel of maintenance that work before     the exhibition of noise generated by planes hunt F-16, or equipments of maintenance of the     same ones, present major risk of a cardiac affectation, which demonstrates in changes in the     normal pace of the heart, in his function of bomb or in hemodynamic conditions.   "
245550|NCT01063595|"     The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas     SD in terms of recovery of coagulation factors and other haemostatic parameters. The     secondary objective of the study was to compare the safety and tolerability of Octaplas LG     with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse     event monitoring.   "
245578|NCT01063959|"     The purpose of this study is to determine laparoscopic sleeve gastrectomy is a safer surgery     than the gastric bypass, gives similar weight losses and that the safety of gastric in     private pay patients versus insurance patients will be similar. This is a retrospective chart     review of intervention charts.   "
245582|NCT01064011|"     Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in     the United States. In the emergent setting, patients with obstructive hydrocephalus are     routinely treated with placement of an external ventricular drain. This study will compare     the effect of external ventricular drainage plus intraventricular thrombolysis versus     external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients     with hydrocephalus from intraventricular hemorrhage.   "
249182|NCT01111266|"     The purpose of this study is to determine the in-vivo ultrafiltration coefficient for     different sizes of xevonta High-Flux dialyzers following FDA guidelines.   "
245551|NCT01063608|"     This project may help to answer several fundamental questions related to public health     regarding vaccination against influenza viruses and regarding the influenza A(H1N1)v pandemy:      What is the immunologic efficacy in terms of antibodies response of the vaccination against     the seasonal (2009-2010) influenza virus and against the A(H1N1)v virus in the clinical     staff?      Moreover, it may help to answer questions related to the use of a vaccine against influenza     virus variants emerging in the French population:        1. Before the vaccination:             -  What is the status of the residual anti-H1N1 seasonal viruses immunity and of the               anti-A(H1N1)v immunity in the population stratified by age and taking into account               the multiplicity of the prior seasonal vaccinations?             -  What is the level of the cellular and humoral cross-reactivity between the               different H1N1 strains?        2. After the vaccination:             -  What is the intensity of the anti-vaccine immune response as a function of the age               of the population ad of the prior seasonal vaccinations?             -  What is the level of the cellular and humoral cross-reactivity after vaccination as               a function of the age of the population and of the multiplicity of the prior               seasonal vaccinations?   "
245552|NCT01063621|"     This is a extended long-term safety study in Parkinson's disease patients who have motor     response complications on levodopa therapy and completed 12 weeks administrations of KW-6500     in 6500-004 study. The safety and efficacy of long-term subcutaneous self-injections of     KW-6500 are evaluated.   "
245553|NCT01063634|"     This is a non-inferiority randomized study to compare a plastic stent without central lumen     (VIADUCT) with self-expandable metal stents for treatment of malignant obstruction of the     common bile duct. It is a non-interventional study, a CE mark for the VIADUCT stent exists.   "
245554|NCT01063647|"     Evaluation of the safety and efficacy of 3 x 10, 3 x 12 or 3 x 14 g/m² Treosulfan resp.,     combined with 5 x 30 mg/m² fludarabine prior to allogeneic, hematopoietic stem cell     transplantation of patients with hematological malignancies, but non-eligible to standard     conditioning treatment.   "
245555|NCT01063660|"     This is a multicenter, multinational, non-randomized, non-controlled open-label phase II     trial to evaluate the safety and efficacy of treosulfan in a combination regimen with     fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in     patients with AML.      The aim is to demonstrate a clinical benefit compared with historical data on intravenous     busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication     conditioning before allogeneic stem cell transplantation.   "
245559|NCT01063712|"     The purpose of this study is to evaluate the safety and the effectiveness of the device     Nit-Occlud® PDA-R in the percutaneous closure of patent ductus.   "
245560|NCT01063725|"     The purpose of this study is to test the effects of Femarelle ( a plan-derived SERM) on hot     flushes and quality of life in menopausal women. Our hypotheses are that compared to placebo,     Femarelle reduces the daily number of hot flushes and their severity and also improves the     quality of life as measured by validated dairies and questionnaires.   "
245561|NCT01063738|"     The study will examine the effect of amino acid supplements and enhanced physiotherapy on     physical recovery following critical illness in intensive care.   "
245562|NCT01063751|"     This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular     Shell for primary total hip replacement (THR) with a cementless application in a consecutive     series of patients who meet the eligibility criteria. Half of the cases will use the X3®     polyethylene insert alone as the bearing surface; the other half will use the MDMTM liner     coupled with a compatible ADM/MDMTM X3® insert as the bearing surface.      The success rate, defined as freedom from acetabular revision for any reason, for hips     implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with     similar technology as reported in the literature and Trident® X3® Study historical control at     5 years postoperative.   "
245563|NCT01063764|"     Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses     up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese     pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with     1 or 2 anti-epileptic drug(s).   "
245579|NCT01063972|"     Our long-term goal is to improve smoking cessation treatment for rural smokers. The objective     is to assess the effectiveness of a centralized disease management program for hospitalized     smokers that coordinates care across treatment settings and links smokers to existing     resources. Our central hypothesis is that Centralized Disease Management (CDM) will increase     the use of smoking cessation treatments and lead to greater long term smoking cessation than     Counseling alone. Demonstrating the effectiveness of a disease management program and     identifying the critical components of such a program will provide a basis for improving the     utilization of existing smoking cessation resources while enhancing the treatment of rural     hospitalized smokers.   "
245663|NCT01065064|"     The purpose of this study is to evaluate the distance, intermediate, and near vision after     aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.   "
245564|NCT01063777|"     The purpose of this study is to evaluate the long term effect of exercise therapy and patient     education compared to patient education only in individuals with hip OA, and to evaluate     predictive factors for changes in hip osteoarthritis both clinically and on x-ray.      Main hypothesis H01: There are no significant long term ( 2 years) differences in hip     function, quality of life, physical function and radiological changes between those     individuals who went through a patient education program and a 12 week exercise therapy     program compared to patient education program only.      Material and Methods:      109 patients with radiographically verified hip OA are included in the randomized controlled     trial; randomized to 12 week exercise therapy program and patient education (n=55) and     patient education program only (n=54).      Data will be collected 2 years after completed intervention period in the original RCT, and 6     months and 2 years postoperatively for those patients who have undergone total hip     arthroplasty.      The main outcome is:      The Disease Specific WOMAC-Index.      Secondary outcome measures are:      Hip X-ray, SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain,     isokinetic muscle strength tests, 6 minute walk test, Åstrand's bike test, range of motion.      Status:      This study is a prolongation of an on-going RCT (3a-2005-NAR). The inclusion, intervention     and follow-ups including 1 year follow-up is completed. 2 year post-intervention follow-up     will be completed in 2010, 2 year follow-up postoperative for patients undergoing total hip     artroplasty will continue throughout 2011.      The study will be carried out: NAR-Orthopedic Centre, Ullevaal University Hospital.   "
245565|NCT01063790|"     Pain after inguinal hernia repair surgery is common with more than 50% of patients reporting     moderate to severe acute pain following surgery. Analgesics are helpful in managing this pain     but patients can be reluctant to take analgesics due to potential adverse effects such as     nausea, vomiting or constipation. Patients may also be concerned about addiction to     analgesics or they may believe that experiencing moderate to severe pain after surgery is to     be expected.      The purpose of this study is to investigate the impact of an individualized education program     regarding pain and management of adverse effects on pain after inguinal hernia repair     surgery.   "
245566|NCT01063803|"     This open-label extension study will allow subjects who have completed either the     3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103     treatment and will provide data on the long-term safety and tolerability of ATN-103 in     subjects with rheumatoid arthritis.   "
245567|NCT01063816|"     The purpose of this study is to determine the maximum tolerated dose of veliparib     (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when     administered in combination with carboplatin and gemcitabine in subjects with advanced solid     tumors.   "
245568|NCT01063829|"     The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the     chances of the cytomegalovirus becoming active again and causing illness after an HBPC     transplant (allogeneic stem cell transplant).   "
245569|NCT01063842|"     The purpose of this study is to compare the number of osteoarthritis patients receiving     titrated or increasing doses of tramadol hydrochloride/acetaminophen combination tablet     (titration group) who discontinue treatment due to adverse events to the number of patients     receiving a non-titrated dose of tramadol/hydrochloride/acetaminophen combination tablet who     discontinue treatment due to adverse events.   "
245570|NCT01063855|"     The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to     placebo in men with premature ejaculation and erectile dysfunction who are currently being     treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for     erectile dysfunction.   "
245571|NCT01063868|"     The purpose of this study is to evaluate the safety profile of orally administered tapentadol     ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral     neuropathy (DPN) over long-term exposure of up to 1 year.   "
245572|NCT01063881|"     The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a     setting similar to routine clinical practice.   "
245574|NCT01063907|"     The purpose of this study is to assess the safety and benefits of the investigational study     drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of     Multiple Myeloma (MM).      The primary objectives:        -  To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478          in combination with bortezomib (Phase I);        -  To assess the overall response rate (ORR) when subjects with advanced MM are treated          (Phase II).      The secondary objectives:        -  To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with          bortezomib (Phase I only);        -  To evaluate for preliminary evidence of efficacy (Phase I);        -  To determine progression free survival (PFS) and duration of response of KW-2478 with          bortezomib (Phase II).   "
245575|NCT01063920|"     LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is     rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric     ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients     receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or     Naprosyn® 500mg (an approved treatment for OA).   "
245576|NCT01063933|"     The purposes of this study are to evaluate the pharmacokinetics (affect the body has on a     drug), and pharmacodynamics (affect the drug has on the body) and safety of an experimental     intravenous (within a vein) flu medication, peramivir, in children. Participants will include     63 hospitalized children with confirmed flu. Children will be grouped according to age and     younger children will not receive drug until safety data from the groups of older children     are reviewed. Hospitalized children may receive up to 5 doses of peramivir. Study procedures     include: nasal/throat swabs, reporting any experienced side effects, physical examination     including assessment of the nervous system, and blood sample collection. Participants will be     involved in study related procedures for up to 28 days.   "
245580|NCT01063985|"     The purpose of this study is to test a new mouse skin test extract on people who work with     mice in a lab or through animal care. It has a higher level of the major allergen and     therefore may be better at diagnosing mouse allergies in this population.   "
245581|NCT01063998|"     The ultimate goal of this project is to develop a simple non-invasive method to screen     patients for potential kidney tumors.   "
245585|NCT01064050|"     A tumoral obstruction of the main stem bronchus is frequently observed in the follow-up of     lung cancers with a high impact on survival and quality of life of these patients. The     endoluminal resection of these tumors through interventional bronchoscopy can remove the     tumor but fails to prevent the recurrence. A stent insertion could achieve this goal but this     option was never proved in a prospective protocol.      The aim of this study is to analyze the impact of stent insertion on the survival without     symptoms of bronchial obstruction in patients treated for their cancer with and without a     first line treatment (chemo-radiotherapy or chemotherapy). The patients will be included     after resection of the endoluminal symptomatic tumoral obstruction. We will test the effect     of the silicone stent insertion ( from NovatechR ) by comparing a stent arm (170 patients     with stent insertion) with a control arm (170 patients without stent). The inclusion period     will last 3 years with one year of follow-up for each patient. The one-year survival without     symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the     treated zone) will be the main endpoint. All patients without symptomatic recurrence at one     year will be controlled endoscopically. Survival and stent tolerance will be studied as     secondary endpoints. All endoscopic events will be depicted on photographs or videos. Each     endoscopical situation (before and after resection, recurrence or side effects of stents)     will be analyzed and registered by an independent committee of 3 international experts.   "
245586|NCT01064063|"     This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate     Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.   "
245587|NCT01064076|"     This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous     implantable defibrillator (S-ICD) System.   "
245588|NCT01064089|"     This study is a phase I dose escalation, multi-center, open-label study of HSP990     administered orally once weekly in adult Japanese and Korea patients with advanced solid     malignancies.   "
245589|NCT01064102|"     A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative     Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys     laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects Under     Fasting Conditions.   "
245590|NCT01064115|"     A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative     Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys     laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects Under Fed     Conditions.   "
245591|NCT01064128|"     Purpose:      The attempt to further reduce the operative trauma in laparoscopic hysterectomy led in new     technique such as Single-Port Access (SPA) laparoscopic surgery. This new technique is     considered as painless procedure and better cosmetic effect but there are not any     publications to study a possible different pain score and cosmetic effect in new techniques     versus conventional laparoscopic hysterectomy. In this randomized controlled study the     researchers have investigated the pain scores and cosmetic satisfaction by modified body     image scale and cosmetic scar scale.   "
245592|NCT01064141|"     The purpose of this study is to investigate the potential for co-administration of the first     dose of CYD Dengue vaccine with childhood vaccination.      Primary Objectives:        -  To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or          coadministered with childhood vaccines.      Secondary Objectives:        -  To describe the immunogenicity of CYD Dengue vaccine after each dose; first dose given          alone or co-administered with childhood vaccines.   "
245593|NCT01064154|"     Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study Of Dr. Reddys Under Fasting     Conditions   "
245594|NCT01064167|"     The aim of this prospective, randomized, double-blinded, placebo-controlled study was to     evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the     postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary     artery bypass graphing (OPCAB) surgery.   "
245595|NCT01064180|"     Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study of Dr. Reddys Under Fed Conditions   "
245596|NCT01064193|"     In vitro fertilization (IVF) is the only available solution for many couples with various     forms of infertility. The embryo implantation step in the IVF procedure is a complex     multistage process and represents the majority of the causes of the IVF failure. Several     approaches have been evaluated to improve implantation rates but none has demonstrated its     superiority. However, endometrial receptivity is important for pregnancy and several studies     suggest that local injury to the endometrium of IVF patients improves the rates of embryo     implantation, clinical pregnancy and live birth.   "
245597|NCT01064206|"     Background: Buerger's disease (thromboangiitis obliterans or TAO) is a rare disease (1/ 10     000) characterized by the development of segmental thrombotic occlusions of the medium and     small arteries of the extremities. Afflicted patients are mostly young, male, inveterate     tobacco (or cannabis) smokers who present with distal extremity ischemia, ischemic ulcers, of     the toes or fingers. Large arteries are typically spared, as are the coronary, cerebral, and     visceral circulations. Patients with TAO often suffer from severe ischemic pain and tissue     loss culminating in minor and major limb amputation. Clinical diagnostic criteria generally     include history of tobacco abuse; age of onset less than 50 years; infrapopliteal, segmental     arterial occlusions with sparing of the proximal vasculature; frequent distal upper extremity     arterial involvement (Raynaud's syndrome or digital ulceration); superficial phlebitis; and     exclusion of arteriosclerosis, diabetes, true arteritis, proximal embolic source, and     hypercoagulable states.      While the cause of Buerger's disease remains unknown, the disease onset and clinical course     are inextricably linked to tobacco (or cannabis) abuse. Tobacco abstinence generally results     in disease quiescence and remains the mainstay of treatment. For some unknown reason,     clinicians observed that TAO patients rarely discontinue smoking even though amputation is     usually the inevitable consequence and the only method available of controlling pain and     ulceration. Few studies were realized and Hofer-Mayer and coll. found remarkable personality     features comparing to coronary patients: TAO patients significantly changed their place of     work more often, had more absenteeism from work, smoked more before the illness and continued     to smoke more frequently during their illness, were more often single or divorced and had     more conflicts in their relationships. Those facts led us to explore their psychopathology     and their addictive profile.      Purpose: Search the prevalence of personality disorders in Buerger's patients who present     with tobacco or cannabis smoking.      Hypothesis: Patients with Buerger's disease show remarkable personality features     (psychological and addictive profile) which are vulnerability factors to stop smoking     (tobacco or cannabis) compared to patients with atheromatous arteritis.   "
245598|NCT01064219|"     Intrauterine injection of hCG around the time of implantation may increase endometrial Treg     cells and improve implantation. It has been demonstrated that regulatory T cells expand     during pregnancy. hCG was found to be secreted by the embryo immediately after fertilization     and has chemoattractant properties to Treg cells.   "
245599|NCT01064232|"     A Single-dose, Randomized, two-Period, Cross over Study   "
245600|NCT01064245|"     Cough is a common, disruptive and at times disabling symptom which often prompts patients to     seek medical attention. Determining the cause(s) of chronic cough can be challenging, and     costly. Asthma and other airway disorders are among the most common causes of chronic cough;     and cough can be the sole symptom of asthma. Little is known about why some patients with     asthma primarily cough and do not develop the other symptoms of asthma such as shortness of     breath or wheeze. Improved understanding of the reasons for these different manifestations     may lead to new and more effective treatment strategies. We have notices differences in     pressure measurements inside the chest in patients who mostly cough during induced     bronchoconstriction, which might be part of the explanation for varying symptoms. This study     will compare lung mechanical responses during methacholine and mannitol-induced induced     airway narrowing between typical asthma, cough variant asthma (CVA) and an airway     inflammatory disorder that is not asthma.The purpose of this research is to explore the     pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and     methacholine-induced cough but normal airway sensitivity using mannitol and high-dose     methacholine bronchoprovocation testing.   "
245601|NCT01064258|"     Background: In patients with obstructive sleep apnea, automatic continuous positive airway     pressure machines (autoCPAP) are said to be capable of identifying various breathing     abnormalities during sleep and to correct them by increasing progressively the positive     pressure applied to the airway. Once breathing becomes normal, pressure slowly declines.     AutoCPAP devices have never been tested in Phase I studies. The investigators hypothesised     that normal breathing would not be recognised as such, and that pressure would increase even     in a normal subject.   "
245602|NCT01064271|"     A Single-dose, Randomized, two-Period, Cross over Study   "
245603|NCT01064284|"     The primary objective of the study is to assess the immunogenicity of VWF/FVIII and of rFVIII     concentrates by determining the frequency of inhibitor development in previously untreated     patients (PUPs) or minimally blood component-treated (MBCTPs) in the first 50 EDs or in the     first 3 years from enrollment, whichever occurs first.   "
245604|NCT01064297|"     Antiepileptic drugs (AEDs) are not indicated for use in pregnancy. However, women with     epilepsy, and other approved indications including bipolar disorder, may require or be     unintentionally exposed to AEDs during pregnancy. Prior to an AED being marketed there are     few data available on drug safety in pregnancy: data from animal models may not translate     directly to humans and pregnant women are routinely excluded from clinical trials. The     International Lamotrigine Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1992     to monitor the safety of lamotrigine during pregnancy.   "
245605|NCT01064310|"     This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in     patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no     prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible patients     will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic     sites of disease (0 and 1 vs. >=2). The study consists of two treatment periods of 10 weeks     with a 2-week wash-out period between the two treatment periods. Patients will receive     pazopanib and sunitinib treatment sequentially in a double-blinded fashion. The primary     objective of the study is to assess how the tolerability and safety differences between     pazopanib and sunitinib translate into patient preference, defined by the patient's stated     preference for which drug they may prefer to continue treatment with at end of study. The     secondary objectives are to evaluate the reason for patient preference as assessed by a     patient preference questionnaire; to evaluate fatigue as assessed by FACIT-Fatigue and     quality of life as assessed by EuroQoL EQ-5D; to evaluate dose modifications and time to dose     modification; and to evaluate safety.   "
245606|NCT01064323|"     Intermittent pneumatic compression (IPC) of the lower extremities is a well-established     technique for preventing deep vein thrombosis (DVT) and for treating venous stasis. IPC will     be done in the home for 3 divided hours every day for 4 weeks. Lab tests, brachial ultrasound     and MRI testing will be performed at baseline and after 4 weeks of daily IPC therapy.      See detailed description for increase in healthy control subjects.   "
245607|NCT01064336|"     Since Idiopathic Thrombocytopenic Purpura (ITP) affects women who are of reproductive     capacity and taking into account the lack of data concerning Eltrombopag (Promacta) use     during pregnancy, the Eltrombopag (Promacta) Registry will be an essential component of the     ongoing risk management for Eltrombopag (Promacta). The Registry will detect and record the     events (live births, spontaneous abortions, stillbirths, elective terminations, therapeutic     terminations, any serious pregnancy outcome, major and minor congenital anomalies, outcomes     including preterm, small for gestation age, or intrauterine growth restriction adverse     adverse effects on the following: immune system development, platelet number and function,     neoplasm formation, bone marrow reticulin formation, thrombotic events) in the mother and/or     the neonate/infant. The adverse events in the infant will be assessed through at least the     first year of life. The Pregnancy Registry will compare the pregnancy and fetal outcomes of     women exposed to eltrombopag Tablets during pregnancy to an unexposed control population.     This study will be a prospective observational, exposure follow-up study.   "
245608|NCT01064349|"     This retrospective cohort study aims to improve our understanding of the current paradigm for     treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We     aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases     diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the     treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives     are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to     investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time     interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence     of brain metastasis as the first site of disease progression.   "
245609|NCT01064362|"     Arixtra (fondaparinux sodium) was the first selective Factor Xa inhibitor to be marketed. As     with all anticoagulants, an important adverse event associated with Arixtra use is     haemorrhage. Previous studies using clinical trial and observational data show no difference     in the risk of haemorrhage in patients treated with Arixtra compared to (low molecular weight     heparins) LMWHs. This study will assess the risk of haemorrhage in major orthopaedic surgery     patients (hip fracture surgery and/or hip/knee replacement surgery) treated with either     Arixtra or LMWH for thromboprophylaxis and will provide additional observational data from a     European country to strengthen the comprehensive review of haemorrhage and the post-marketing     safety of Arixtra. All patients age 18 years and older with a primary discharge diagnosis for     hip fracture surgery and/or a hospitalization for hip and/or knee replacement surgery from     the PHARMO RLS database in the Netherlands are eligible for participation. For study     inclusion patients must receive either Arixtra or LMWH as initial in-hospital     thromboprophylactic agent and have at least three months in the PHARMO RLS database before     cohort entry date. Patients with a history of hospitalization for haemorrhage, renal failure     or liver failure in the past 3 months will be excluded. Descriptive statistics, including     gender, age, length of treatment, co-morbidities, concomitant medications, and other     covariates will be calculated.      Data for this study were obtained from different registers in the PHARMO medical record     linkage system (PHARMO RLS) in the Netherlands. The PHARMO medical record linkage system is a     population-based patient-centric data tracking system that includes high quality and complete     information of patient demographics, drug dispensing, and hospital morbidity records of     approximately 2.3 million community-dwelling inhabitants of 48 geo-demographic areas in the     Netherlands. The PHARMO registers are linked on a patient level and contain unprecedented     accurate and complete information required for the study.      The out patient database contains drug dispensing data in the U-Expo database are encoded     according to standards based upon the Z-Index drug database (www.z-index.nl). Therefore, it     is possible to identify and classify drug use in time, both on the basis of national and     international classification schemes as well as on the basis of individual active ingredients     and administration forms. Of each dispensed drug, the Anatomical Therapeutic Chemical (ATC)     code, the dispensing date, the prescriber, the prescribed dosage regimen, the dispensed     quantity, the cost and the estimated legend duration of use are available.      The hospital pharmacy database comprises hospital pharmacy data collected in a growing number     of non-academic hospitals in the Netherlands. Currently, data are collected on patient level     for more than one million patients from a representative sample of non-academic hospital     pharmacies scattered over the Netherlands. The hospital pharmacy database includes data on     in-patient medication orders such as type of drug, dose, and time of administration and     duration of use.      The Dutch Medical Register (LMR) is the data source comprising all hospital admissions in the     Netherlands (www.prismant.nl). These records include detailed information concerning the     primary and secondary discharge diagnoses, diagnostic, surgical and treatment procedures,     type and frequency of consultations with medical specialists and dates of hospital admission     and discharge. All diagnoses are coded according to the International Classification of     Diseases, 9th edition (ICD-9-CM). Currently, data until December 2008 are available.   "
245664|NCT01065077|"     A placebo controlled, double-blind and randomized study to assess different doses of a new     drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the     well-being of patients with acute decompensated heart failure.   "
245835|NCT01067508|"     The aim of this research study is to determine by laboratory analyses the effects of drinking     silicon-rich water on bone health. This will be determined from blood and urine samples from     subjects who will be asked to drink 1 liter per day of either silicon-rich water or water     without silicon for 12 weeks.   "
245610|NCT01064375|"     The purpose of this study is to evaluate the safety and immunogenicity of a CEA DNA     immunisation approach in patients with colorectal cancer. The DNA plasmid, tetwtCEA, encodes     wild type human CEA fused to a tetanus toxoid T helper epitope. The vaccine will be delivered     using an intradermal electroporation device, Derma Vax (Cyto Pulse Sciences). The following     will be assessed:        -  The efficiency of priming immunological responses to CEA by intradermal administration          of CEA DNA in combination with electroporation.        -  The efficiency of boosting immunological responses to CEA by intradermal administration          of CEA DNA in combination with electroporation in subjects already vaccinated with CEA          DNA.        -  GM-CSF will be administered to half of the subjects primed with CEA DNA in combination          with electroporation and any possible adjuvant effects of GM-CSF will be evaluated.   "
245611|NCT01064388|"     The purpose of this study is to determine the safety, tolerability and blood levels of     AZD9742 after daily dosing for 14 days.   "
245612|NCT01064401|"     The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC     HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in     participants with relapsing remitting multiple sclerosis.      The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in     slowing functional decline and disability progression and maintaining quality of life in this     participant population.   "
245613|NCT01064414|"     The purpose of this study is to evaluate the efficacy and safety of 2 different doses of     canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have     reduced kidney function.   "
245614|NCT01064427|"     The aim of this study is to identify the determinants of cancer-related fatigue, and the     long-term effect of the different adjuvants treatments will be explored. A prospective     longitudinal study in women diagnosed for the first time with stage I-III breast cancer and     who have undergone surgery, has been designed to meet the study aims.   "
245615|NCT01064440|"     The purpose of this study is to evaluate whether intramuscular injections of VM202 into the     calf is safe and effective in the treatment of critical limb ischemia.   "
245616|NCT01064453|"     Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy     in real practice for the indication approved by Korea Food and Drug Administration (KFDA).     This is non-interventional , prospective, multi-center study.Target number of patients is     4500.   "
245617|NCT01064466|"     Personalized or individualize Etoposide (VP-16) chemotherapy targeting the SCLC     patient-specific biomarkers (Single Nucleotide Polymorphisms - SNPs of relative etoposide     targets, topoisomerase II and CYP4503A4)      Targeted SCLC chemotherapy with Etoposide (VP-16) and patient-specific biomarkers (SNPs)      Individualize or personalize etoposide chemotherapy toward small cell lung cancer (SCLC) with     maximizing effectiveness via assay single nucleotide polymorphisms (SNPs) of relative     etoposide target - topoisomerase II, and minimizing risk via assay single nucleotide     polymorphisms (SNPs) of relative etoposide target - CYP4503A4, based on precisely sequencing     drug targets' genes.   "
245618|NCT01064479|"     The goal of this clinical research study is to learn if adding Tarcevaâ (Erlotinib, OSI-774)     to the combination of docetaxel and cisplatin/carboplatin can help control SCCHN better than     chemotherapy alone, in patients with SCCHN that has spread to other parts of the body or has     come back after treatment. The safety of this drug combination will also be studied.   "
245619|NCT01064492|"     PF 04620110 is an acylCoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitor that is being     developed for the treatment of type 2 diabetes mellitus (T2DM). It is anticipated that PF     04620110 will have anti diabetic effects through inhibition of intestinal triglyceride     absorption and potentially weight loss. The primary purpose of this study is to evaluate the     pharmacokinetics, safety and tolerability of multiple oral formulations of PF 04620110     administered to healthy volunteers.   "
246726|NCT01081106|"     The purpose of this study is to see whether low level laser therapy can help maintain normal     hair growth on the scalp in people receiving chemotherapy, which is generally associated with     hair loss.   "
245620|NCT01064505|"     This is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where     active study drug (QPI-1007) will be given to all patients who participate.      This study will determine whether QPI-1007 is safe when it is injected into the eye. The     study will also reveal if there are any side effects of the drug and how long it takes for     the body to clear the drug.   "
245621|NCT01064518|"     The purpose of this study is to find out if an investigational drug, called RT001 Botulinum     Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and     hairline called crow's feet, also known as lateral canthal lines.   "
245622|NCT01064531|"     The objectives of this study are to assess migration of the MIS Stem compared to the Synergy     Hip System, and to assess the long-term safety and effectiveness of the study device using     Radiostereometric Analysis (RSA). This study will document any device-related surgical or     post-operative complications and adverse radiographic observations.      Patients meeting the entrance criteria specified in this protocol will be randomized as they     become available.   "
245623|NCT01064544|"     Previous research has shown that sleep quality in hemodialysis patients is disturbed. One of     the possible explanations is an insufficient or disturbed melatonin rhythm. Melatonin rhythm     is regulated by exposure to light. In this feasibility study, the investigators examine the     effects of light therapy during dialysis on sleep, melatonin rhythm and mood.   "
245624|NCT01064557|"     The main purposes of the AIDA protocol are to test the role of intermittent maintenance     therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine     of both in PCR negative patients at the end of the consolidation phase and to evaluate the     role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the     end of the consolidation phase.   "
245625|NCT01064570|"     Prospective use of RT-PCR for PML/RARa might be used to guide a total tehrapy approach in     APL, including refined diagnosis, front-line treatment, assessment of response and     anticipated salvage therapy for patients who undergo molecular relapse.   "
245626|NCT01064583|"     To characterize potential vascular long-term effects of flavanols in patients with peripheral     artery occlusive disease (PAOD), a placebo-controlled double-blinded randomized control study     will be performed in 62 patients randomized in two groups. Patients will twice daily receive     either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of 60 days     months.   "
245675|NCT01065402|"     To evaluate the efficacy of PPB-R-203-Based Meal and TK9-Based Meal on blood glucose control     in 20 patients with diabetes for 2 days.   "
245628|NCT01064609|"     Transbronchial lung biopsy (TBLB) is a bronchoscopic procedure used to obtain peripheral lung     tissue. Small size and artefacts cause variable, and usually poor, diagnostic yield. The use     of cryoprobes may allow for larger size and better quality biopsy samples.      Objectives:To analyze the histological quality and immunohistochemical findings of samples     obtained by cryoprobe compared with TBLB obtained by conventional forceps and to assess the     safety and complications of TBLB with cryoprobe versus the conventional method.      Methodology:      Prospective randomized study of 80 patients. The transbronchial lung biopsy was indicated for     diagnoses of a interstitial lung disease. In both procedures the videobroncoscopy used will     be a Olympus 260-T.      The transbronchial lung biopsy will be carried out with conventional forceps (Boston ® Biopsy     Forceps, Ref 1556 and Olympus ® FB-19E) and cryoprobe (Erbokryo AC ®). TBLB will be performed     by fluoroscopy guided and the cryoprobe or forceps will place in an area of the peripheral     lung previously selected according to CT findings. Lung biopsies will be processed: The     samples submitted for histological analysis will be fixed in formalin and embedded in     paraffin. Staining will perform with hematoxylin-eosin and Masson's trichrome and the samples     will be analyzed by a pathologist according to a protocol. The samples submitted to     immunohistochemical study will be frozen (liquid nitrogen) for later transport.The specifical     monoclonal antibodies will be used for immunohistochemical analysis.   "
245629|NCT01064622|"     This randomized phase I/II trial is studying gemcitabine hydrochloride and vismodegib to see     how well they work compared with gemcitabine hydrochloride alone in treating patients with     recurrent or metastatic pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Vismodegib may slow the growth of tumor cells.     It is not yet known whether giving gemcitabine hydrochloride together with vismodegib is more     effective than gemcitabine hydrochloride alone in treating patients with pancreatic cancer.   "
245630|NCT01064635|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast     cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen     of letrozole is most effective in treating breast cancer in postmenopausal women who have     received tamoxifen.      PURPOSE: This randomized phase III trial is comparing different regimens of letrozole to see     how well they work in treating postmenopausal women with stage I, stage II, or stage III     breast cancer previously treated with tamoxifen.   "
245631|NCT01064648|"     This randomized phase I/II trial is studying the side effects and best dose of cediranib     maleate when given together with pemetrexed disodium and cisplatin and to see how well it     works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy,     pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Cediranib maleate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed     disodium and cisplatin together with cediranib maleate may kill more tumor cells.   "
245632|NCT01064661|"     We are conducting a study to learn if probiotics, which are live bacteria found in food like     yogurt and cheese, will improve symptoms of abdominal pain. Individuals participating in this     study will take probiotic pills to see if this affects the expression of certain pain     receptors in the intestines that relate to pain sensation. Biopsies will be taken from the     colon before subjects take the probiotic pills. Subjects will then be given one of two     different types of probiotic pills to take for 3-4 weeks. After taking the supplements, more     biopsies will be collected to see if any changes have taken places. This study requires one     screening visit and two clinic visits to UNC hospital. Subjects will also complete daily     diary cards for 2 weeks during the study to record their symptoms and also collect 2 stool     samples.   "
245634|NCT01064687|"     The purpose of this study is to determine if LY2189265 is effective and safe in reducing     hemoglobin A1c (HbA1c), as compared to placebo (no medicine), or exenatide in participants     with Type 2 Diabetes. The participants must also be taking metformin and pioglitazone.   "
245635|NCT01064700|"     The primary aim of this research was to examine the influence of bright light on anxiety in     high-anxious young adults. In an acute exposure study, participants were randomly assigned to     45 min of either (1) bright light (3,000 lux) or (2) a placebo inactivated negative ion     generator. Treatments were initiated ≤1 hr after awakening. At 10 min before and 30 min after     the treatments, state anxiety, mood, and blood pressure were assessed.      Following the acute exposure study, participants performed a 5-week study. Following a a     1-week baseline, participants were randomly assigned to four weeks of daily exposure to     either (1) bright light (45 min/day; 3,000 lux) or (2) placebo inactivated negative ion     generator, which were initiated ≤1 hr after awakening. Before and after the experiment,     clinical ratings were conducted with the Hamilton Anxiety Scale, the Hamilton Depression     Scale, and the Clinical Global Impressions scale (CGI). Following baseline, and following     each week of treatment, blood pressure, as well as questionnaires for state anxiety,     depression, mood, sleep, and side effects were assessed.   "
245636|NCT01064713|"     The goal of this clinical research study is to learn if tesetaxel can help to control     metastatic melanoma. The safety of this drug will also be studied.   "
245637|NCT01064726|"     After a nasal allergen challenge it should be possible to measure markers of inflammation     that may be useful to assess the properties of future drugs. If these markers are     reproducible and impacted by the study drugs they could be useful for future drug     development.   "
245691|NCT01065610|"     This study investigated, if people with impaired coping abilities benefit from intranasal     oxytocin application.   "
245692|NCT01065623|"     Clinical study to determine safety, tolerability, to measure how the drug is metabolized by     the body and to determine the maximum tolerated dose of BAY79-4620 given every 2 weeks to     patients with advanced solid tumors   "
249183|NCT01111279|"     The purpose of this study is to assess the safety and tolerability of gpASIT+TM administered     subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen     allergic patients.   "
245638|NCT01064739|"     The purpose of this study is to learn how plants can play a role in gain/loss of sodium in     the urine and in the regulation of blood pressure. Dopamine is a chemical mostly present in     the brain and kidneys which assists in regulation of the body's salts (sodium and potassium).     Fava beans contain a lot of the chemical that increases the production of dopamine by the     kidneys.      The purpose of these studies is to characterize the diuretic effects of dietary catecholamine     sources in healthy individuals. Specific aims are:        1. To determine the effect of dietary dopa sources on plasma and urinary catecholamines.        2. To investigate the capacity of botanical dopaminergic agents (fava beans) to induce          natriuresis in a short term study.        3. To provide preliminary data on the effects of dietary dopa on heart rate and blood          pressure.      In these studies, we will test the null hypothesis (Ho) that urinary sodium excretion will     not differ in healthy volunteers after consumption of a fixed-sodium study diet and the study     diet plus fava beans.   "
245639|NCT01064752|"     This will be an uncontrolled, open-labelled pilot study exploring whether minocycline has a     measurable and selective effect on HIV infection of the central nervous system.   "
245640|NCT01064765|"     This study is designed to determine if a relationship exists between problems with memory,     attention, learning, insight and executive function and self management in heart failure.   "
245641|NCT01064778|"     The investigators propose examine the effects of the dietary factor glycemic index (GI) on     brain areas that control food intake and hunger. This knowledge could help design dietary     approaches that decrease hunger, and thus promote new weight loss strategies.   "
245642|NCT01064791|"     This study will assess the safety and efficacy of different doses of sotrastaurin when     combined with tacrolimus for the prevention of acute rejection after de novo renal     transplantation.   "
245643|NCT01064804|"     To test the relative bioavailability of PF-04191834 when dosed as an Immediate Release tablet     compared with solution following single and multiple dosing.   "
245644|NCT01064817|"     This study will assess the safety and tolerability of PRM-151 administered as a     subconjunctival injection and explore the effect of PRM-151 on various correlates of the     wound healing process that occurs in the eye after glaucoma filtration surgery.   "
245645|NCT01064830|"     Brittle nail syndrome (BNS) refers to nails that exhibit splitting, raggedness (fraying of     the distal edge), and peeling (lamellar onychoschizia).(1) This is a common problem,     affecting approximately 20% of women, with higher prevalence among the elderly.(2) A number     of factors have been proposed as possible causes of nail brittleness, such as anemia, biotin     deficiency, or cysteine deficiency. (3,4) However, most authors believe that brittle nails     are usually caused by dehydration of the nail plate, either from repetitive cycles of     hydration and dehydration related to hand washing or from exposure to dehydrating chemicals,     such as those found in nail enamel and cuticle removers. (5,6) Inflammation of the nail as a     potential contributing factor has never been studied.      There are currently not consistently effective treatments for this condition. Restasis® is     effective in treating keratoconjunctivitis sicca. This condition is characterized by the     troublesome condition of dry eyes partially due to decreased tear production exacerbated by     inflammation. The BNS manifests itself by nail plate dehydration. The two conditions have in     common disruption of water balance which gives rise to problematic clinical disorders. The     hypothesis is that a product which benefits tear production would also be effective for     brittle nails which contain roughly 15% water.   "
245646|NCT01064843|"     Stabilization of existing full lower dentures by means of mini-dental implants (MDI). To test     whether 4 mini-implants placed at the front of the lower jaw can stabilize an     immediately-modified existing lower denture.   "
245757|NCT01066481|"     The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the     treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study     enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients     completing the 6-month study will be eligible to receive PF-01913539 in an open-label     extension trial (B1451031).   "
245647|NCT01064856|"     The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg     administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks     followed by open label (OL) safety and efficacy assessments in participants with     non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral     spondyloarthritis (SpA) who have had an inadequate response to >= 2 non-steroidal     anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for,     NSAIDs.   "
245648|NCT01064869|"     Approximately 5% of adults with asthma have difficult to control disease but these account     for up to 80% of total cost of asthma due to recurrent healthcare contact including hospital     admission. The reasons for difficult asthma are multi-factorial, but an important element     in many patients is non-adherence to steroid therapy. Recent qualitative analysis by the     investigators group has identified a number of both individual and group themes, related to     non-adherence with steroid treatment. Many of these themes such as steroid phobia, inaccurate     / lack of knowledge, negative attitudes and inability to deal with side-effects, are     potentially modifiable and the investigators believe, unless these issues are addressed, at     an individual patient level, adherence is unlikely to improve. This randomised parallel group     study will examine a nursing intervention to try and improve adherence and as a consequence,     asthma control, in a group of difficult asthmatics where non-adherence has been identified as     a significant factor. The study will use a needs-led menu driven individualised intervention     and will compare this to current best asthma care. The primary outcome measure will be     adherence to therapy, however asthma control, lung function and asthma related quality of     life, patients' attitudes to asthma and treatment and their levels of anxiety and depression     will also be examined. Addressing the issue of non-adherence is fundamental to improving     asthma management in this difficult group with concomitant reduction on health care costs and     improvements in patients' quality of life   "
245649|NCT01064882|"     This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or     0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the     upper eyelid margins in increasing eyelash prominence   "
245704|NCT01065779|"     This survey is conducted for preparing application materials for re-examination under the     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the     clinical usefulness of FOSAMAX PLUS / FOSAMAX PLUS D through collecting the safety     information according to the Re-examination Regulation for New Drugs.      Note: FOSAMAX PLUS D is known as FOSAMAX PLUS in several markets. FOSAMAX PLUS (70 mg/2800     IU) and FOSAMAX PLUS D (70 mg/5600 IU).   "
245650|NCT01064895|"     This is a prospective, observational, multi-center study with consecutive enrollment. Up to     500 patients will be enrolled. All (consecutive) adult patients in whom one or more     components of the Benephit Infusion System are planned to be used at participating sites are     eligible for enrollment. The objective of this post-marketing surveillance study is to     collect clinical usage patterns of the Benephit Infusion Systems. As a result, AngioDynamics     will be able to (1) Better understand and quantify usage patterns including patient     characteristics, adjunctive procedures, and infusion agents, (2) Collect user-interface     information and overall customer satisfaction, and (3) Monitor post-marketing device     performance and safety for ISO quality adherence.   "
245651|NCT01064908|"     The purpose of this study is to determine the effectiveness of oxygenation and     patient-acceptability of a novel oxygen face mask in patients undergoing carotid     endarterectomies (CEAs).   "
245652|NCT01064921|"     RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill     tumor cells. Giving vorinostat together with chemotherapy and radiation therapy may kill more     tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when     given together with cisplatin and radiation therapy in treating patients with stage III or     stage IVa squamous cell cancer of the oropharynx which is either unresectable or borderline     resectable.   "
245653|NCT01064934|"     Lipoprotein(a) [Lp(a)] is an independent risk factor for cardiovascular disease. Non-medical     treatment measures (e.g. dietary therapy or weight loss) can hardly influence Lp(a) plasma     concentrations. Drug therapy has only limited influence, e.g. treatment with niacin. Statins     are usually without effect. Lipid apheresis is the only treatment known to lower elevated     Lp(a) levels in a relevant way. In patients with pronounced elevation of Lp(a) and normal LDL     cholesterol levels, who suffer from progressive cardiovascular disease, the treatment with     lipid apheresis seems to be a last-resort treatment option. The current trial will evaluate     the effectiveness of lipid apheresis on cardioavascular endpoints.   "
245654|NCT01064947|"     Skin infections may complicate the treatment of atopic dermatitis.The use of topical     ointments has become very important to avoid the use of oral antibiotics. There is little     supporting literature regarding the use of topical antibiotics in secondarily infected atopic     dermatitis.      This study will investigate the safety and effectiveness of Altabax ointment use in treating     secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus     pyogenes.   "
245655|NCT01064960|"     This study is to collect supplementary safety and technical effectiveness data of Philips MRI     guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with     symptomatic fibroids in a 3T MRI scanner. The importance of this therapy is that it offers a     non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and     peri- menopausal women. MRI guided high intensity focused ultrasound uses ultrasound to heat     and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and     monitors heat rise in the fibroid tissue. The goal of the study is to collect supplementary     3T treatment safety and technical effectiveness data in a 1 month follow-up study. MRguided     HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of     life, and imaging endpoints will be evaluated in all study patients.   "
245758|NCT01066494|"     A phase IIa study to evaluate the pharmacokinetic and efficacy of amonafide L-malate (AS1413)     in combination with cytarabine in treating patients with acute myeloid leukemia (AML)   "
245656|NCT01064973|"     Study 22003, An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of     STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)     currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem     behaviors, such as irritability and aggression, in subjects with ASD. This study (22007) will     enter subjects who complete Study 22003 into a long-term, open-label study.The open-label     extension protocol will provide necessary data on the long-term safety and tolerability of     STX209 among subjects with ASD who receive treatment under conditions more closely reflective     of their general medical care.   "
245657|NCT01064986|"     Corticosteroids are substances produced by the adrenal gland to help the body fight against     infection or injury. Hydrocortisone is a man-made form of this substance. Endotoxin is a     man-made substance, which causes the body to mimic sickness(fever,chills,and achiness)for a     few hours. This study is designed to give hydrocortisone before and after Endotoxin to     determine if this medication can prevent or relieve any of the symptoms caused by the     Endotoxin.   "
245658|NCT01064999|"     Neoadjuvant chemoradiotherapy (CRT) has been the standard therapy for local advanced rectal     cancer. Pathological complete response (pCR) is an important prognostic factor for local     control and survival. A high intensity CRT increases not only the pCR rate, but also     toxicity, especially diarrhea. Compared with traditional RT technique, intensity-modified     radiation therapy (IMRT) can decrease the toxicity of diarrhea because of low volume of high     dose for small bowel. Therefore, IMRT technique provides an opportunity to improve the dose     intensity of neoadjuvant CRT. The investigators hypothesize that a higher treatment dose     induces a high rate of pCR and design a two-arm trial. in this trial, low intensity CRT     includes the whole pelvic irradiation of 50Gy together with Oxaliplatin and Capecitabine     weekly. While in high intensity group, additional concomitant 5Gy for primary tumor and a     cycle of Xelox are prescribed. All patients will receive a total mesorectal excision (TME) 8     weeks after CRT.   "
245659|NCT01065012|"     Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally     administered selective inhibitor of PDE-5 for the treatment of subjects with erectile     dysfunction (ED).   "
245660|NCT01065025|"     The purpose of the study is to investigate safety and tolerability of repeated ascending oral     doses of 4SC-205 in patients with advanced and incurable solid tumors or malignant lymphomas.   "
245661|NCT01065038|"     Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was     not inferior to HU with respect to efficacy in patients with ET. This approach to demonstrate     non-inferiority was based on the following decision points:      • ET is a rare disease and recruitment of large patient number (> 1600) to prove superiority     was not considered possible.      . It was decided to recruit only treatment naïve high risk patients to avoid pre-treatment     bias, which further limited the number of patients eligible for the study.   "
245665|NCT01065090|"     The primary objective of the investigation is to determine whether the addition of exercise     (resistance training or modified physiotherapy) improves functional capacity in Multiple     Sclerosis (MS) participants undergoing Disease Modifying Therapy (DMT) treatment. We     hypothesize that the Progressive Resistance Training (PRT) will improve functional capacity     without increasing the risk of relapses in participants undergoing standard DMT treatment.     The secondary objectives are to determine whether exercise (resistance training or     physiotherapy) improves fatigue, mood and Quality of Life (QoL) in MS participants undergoing     DMT treatment. Also as a secondary objective, the study aims at determining whether exercise     (resistance training or modified physiotherapy) has an impact on Expanded Disability Status     Scale (EDSS), time to first relapse, number of relapse free participants, and immunological     factors. We hypothesize that the exercise (resistance training) will improve fatigue, mood     and QoL and that an impact on immunological factors will be seen in participants even though     they are undergoing standard DMT treatment.   "
245666|NCT01065103|"     It has been shown that if it can be accomplished within a 90 minute door to balloon time,     opening an artery in an acute heart attack situation (ST elevation myocardial infarction or     STEMI) is best treated with balloon angioplasty and stenting (percutaneous coronary     intervention or PCI). In these situations, there may be narrowings other than the one causing     the heart attack (culprit) and studies have shown that delaying treatment of other narrowings     for follow-up procedure is better than intervening at the time of the acute MI.   "
245667|NCT01065116|"     The purpose of this study is to determine if adherence and effectiveness of AL in the     treatment of uncomplicated malaria in children aged under five years using blister packs with     pictorial leaflets can be at levels comparable to those with unit dosed age specific     pre-packs.   "
245668|NCT01065129|"     Our main objectives are to determine the optimal dose and schedule of plerixafor + G-CSF and     azacitidine in patients with MDS and determine the safety and tolerability of plerixafor +     G-CSF and azacitidine.   "
245669|NCT01065142|"     Use lay language. Background: Heart failure is an increasingly frequent current pathology due     to the population aging and the improvement of acute and chronic heart failure management.     Heart failure patients have a poor quality of life because of their symptoms (asthenia,     dyspnea…) and frequent hospitalizations. Heart failure is an expensive disease: 1.5 % of the     health expenses, 85 % in hospital cost with 200 000 hospitalizations in France per year.     Previous studies were multidisciplinary interventions and not realistic in a daily practice     for a general practitioner. The aim of this project is to integrate therapeutic education for     heart failure patients in a current practice. The patient becomes competent to manage his     disease and to identify acute heart failure signs.      Main objective: Improve therapeutic education efficiency on life quality of heart failure     patients in general practice.      Second objectives: Describe heart failure patient's hospitalizations.      Methods: Cluster randomized controlled clinical trial comparing intervention and control     groups with a follow through for 19 months for each patient. A therapeutic education program     will be proposed to the heart failure patients in primary care. The intervention group GP     will follow a workshop concerning the therapeutic education concepts and the intervention.      Endpoints: Life quality evaluation (SF-36 and Minnesota scales) and number of     hospitalizations of patients in each group.      Population: Heart failure patients in stages I, II, and III of NYHA in primary care. Cluster     randomized surgeries in Auvergne (France).      Expected results: The therapeutic education allows the patients to improve their quality of     life, to be able to detect their illness signs worsening in a early manner, and to contact     their doctor if needed. This would limit the acute heart failure due to treatment adaptation     or life habits.   "
245728|NCT01066104|"     The investigators are doing this research study to learn more about a drug called Xolair     (omalizumab). The investigators want to see if it is an effective treatment for chronic     rhinosinusitis (CRS). Specifically, the investigators want to see whether Xolair will make     nasal polyps smaller and less thick, and relieve symptoms in people with CRS. Polyps are     abnormal growths of tissue that can grow in the lining of your sinuses (the inside of your     nose). The investigators also want to find out if it is safe to use (whether it causes side     effects).   "
245670|NCT01065337|"     Diabetic foot patients with chronic limb ischemia and without the option for surgical or     interventional revascularization were recruited and randomized to the transplant groups or     the control group within this clinical trial. These patients are randomized to control or     intervention group, whereas the intervention is divided into bone marrow cells administered     intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or     intraarterial resulting in five distinct groups. To measure the therapeutic effects of the     various treatment arms patients were evaluated for (ankle brachial index (ABI),     transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level     Dependent [BOLD]). Patients also underwent imaging with angiographic methods.   "
245671|NCT01065350|"     This is a pilot study to compare the hemodynamic changes that occur during induction with a     novel drug combination known as ketofol (propofol and ketamine admixture with that of     propofol alone (prototypic anesthesia induction agent). Propofol and ketamine are widely used     as induction agents and their effects on patient hemodynamics are well known. Some of these     drug-induced hemodynamic changes are undesirable and lead to deleterious effects on patient     hemodynamics. We seek to investigate the hemodynamic changes associated with a novel drug     combination known as ketofol (ketamine/propofol admixture) during induction and compare them     to propofol. If we determine that the changes produced by ketofol are favorable compared with     propofol, we then will seek to test its use in the trauma setting in a subsequent randomized     controlled trial.   "
245672|NCT01065363|"     The investigators propose a project of preventive medicine with concern of local context in     Taiwan. The target population includes all staff and faculty members, students, and alumni of     a university in Northern Taiwan, with chronic hepatitis B infection. The intervention of this     project includes standardized lectures, sports courses, nutrition courses, and an information     platform. The investigators will evaluate the efficacy after the intervention, like the     reduction of hepatitis B viral load and the associated anthropometric parameters. The results     of this project will be initially served as a pilot study for this cohort, and applicated as     a promising basis for health promotion.   "
245673|NCT01065376|"     The dopamine agonist cabergoline inhibits phosphorylation of the vascular endothelial growth     factor receptor-2(VEGFR-2), which prevent vascular endothelial growth factor (VEGF)     overexpression and reduce the severity of Ovarian hyperstimulation syndrome. However, VEGF     plays an important role in the growth and maintenance of ovarian follicle and developing     embryo by mediating angiogenesis.This study was designed to analyze whether the timing     cabergoline administration on the day of human chorionic gonadotropin (hCG) injection or     after oocytes retrieved affects the oocyte maturation and outcome of assisted reproduction     treatment.   "
245674|NCT01065389|"     Dialysis patients usually have peripheral muscle weakness due to metabolic disturbances     (increased protein catabolism) and fatigue. This muscle weakness may decrease functional     capacity and quality of life. It also serves to increase cardiovascular risk factors in these     end stage renal disease patients. Peripheral muscle strength training shall combat physical     inactivity during dialysis. In the investigators trial, the investigators hypothesis that     peripheral muscle training might regulate protein catabolic rate,renal functions,     cardiovascular risk factors, improve functional capacity and quality of life in endstage     renal disease patients undergoing dialysis.   "
245676|NCT01065415|"     The accurate staging is an essential part for the treatment and prognosis of non-small-cell     lung cancer (NSCLC). Whole body MR imaging proved to be effective in staging of NSCLC as much     as PET/CT. And there were organs of strength for each modality in the detection of     metastasis. Therefore, integrated approach using whole body MR and PET would be more     beneficial for the accurate staging of lung cancer with improved diagnostic efficacies and     reduced radiation exposure.      The aim of this project is to evaluate the diagnostic efficacy of side-by-side reading of     whole-body magnetic resonance imaging/ positron emission tomography (MRI/PET) and to compare     with that of whole-body magnetic resonance imaging (WB MRI) alone and that of integrated     PET/CT in determining the stage of NSCLC.      Patients with pathologically-proven NSCLC will be prospectively enrolled, if they are     considered as surgical candidates for the treatment of lung cancer through conventional     methods of staging, i.e. history taking, physical examination, blood tests, bronchoscopy, and     enhanced chest CT scans. PET/CT will be routinely performed for the staging of lung cancer in     our institution. For the purpose of this study, whole body MRI will be performed for these     patients within 3 days from the date of acquisition of PET/CT. The results of TNM staging     from each modality will be collected prospectively and their efficacies can be calculated     based on the reference standards. Reference standards of T and N staging will be surgically     confirmed. And M staging can be confirmed by biopsy, other imaging modalities, or follow-up     more than 6 months.      Diagnostic efficacies of coregistered MRI/PET can be evaluated with the comparison from the     consecutive two-arm enrollment with random assignment of control group and study group as     follows:        -  control group: routine staging work-up with chest CT, PET/CT, and brain MRI        -  study group: routine staging work-up plus whole body MRI for Coregistered MRI/PET   "
245677|NCT01065428|"     The aim of this study was to compare the indices of rapid shallow breathing, neuromechanical     efficiency (NME), and neuroventilatory efficiency (NVE) between patients being successfully     extubated and those who failed weaning.   "
245678|NCT01065441|"     A Phase I/II study of an in-situ therapeutic cancer vaccine. Vaccines contain a source of     antigen and and adjuvant. In this study the source of tumor antigen comes from the killing of     a selected tumor by cryoablation (killing using extreme cold) and the adjuvant is     intentionally mis-matched immune cells (AlloStim-TM) engineered to produce inflammatory     cytokines.   "
245679|NCT01065454|"     The aim of this study is to assess whether increasing oral doses of Riociguat are safe and     improve the well-being, symptoms and outcome in patients with pulmonary hypertension     associated with left ventricular systolic dysfunction   "
245680|NCT01065467|"     The purpose of this research study is to determine the safety of LBH589 as well as to find     out what side effects it may cause and how effective it is against melanoma. LBH589 is a drug     which may slow down the growth of cancer cells or kill cancer cells by blocking certain     enzymes, which are proteins normally produced by cells. These enzymes are known to play an     important role in the development and reproduction of cancer cells. It is believed that     LBH589 works by helping to promote the activity of enzymes which turn on the mechanisms in     our cells that suppress cells from becoming cancerous.   "
245681|NCT01065480|"     This study aims to train Substance Abuse Treatment Clinicians in the use of Motivational     Interviewing techniques through live supervision.   "
245729|NCT01066117|"     The purpose of the proposed study is to test the effect of the new gel pad on the quality of     life of urinary incontinent men and women and to assess to what extent the gel pad improves     the quality of life of incontinence persons.   "
245730|NCT01066130|"     The aim of this study is to evaluate the results of psychosocial treatment in patients with     newly diagnosed rheumatoid arthritis and/or diabetes.   "
245682|NCT01065493|"     QuitAdvisorMD: A point-of-care tool for brief smoking cessation interventions Under a Phase     II SBIR grant supported by NIH/NIDA, we are developing QUITAdvisorMD: a point-of-care,     patient-centered resource for counseling patients who smoke or use tobacco products. It is     based on the principles of Motivational Interviewing, a non-confrontational and very     effective method for intervening and treating these patients; the 5 A's of behavioral     interventions; and the Transtheoretical Model of Change. Through a point and click interface,     the tool uses a series of interview questions designed to motivate patients to stop smoking     by first assessing their stage of change and then offering effective stage-based     interventions and interview techniques. The tool also offers stage-tailored patient     information, a clinician educational reference, and the ability to communicate support     information patients via email and/or text message.   "
245683|NCT01065506|"     The primary aim of this research study (STEP) is to compare the effectiveness of two smoking     cessation programs that integrate counseling and nicotine replacement with either a wellness     program or exercise. This will help us to determine whether different lifestyle interventions     (wellness or exercise) help increase the effectiveness of current standard programs for     smoking cessation.   "
245684|NCT01065519|"     Assessment of vessel healing after DES implantation in STEMI, NSTEMI and stable/unstable     angina patients: a randomized comparison between everolimus and biolimus A9-eluting stents:     an optical coherence tomography (OCT) and intravascular ultrasound-tissue characterisation     (IVUS-TC) study.      Plaque characterisation substudy: Assessment of culprit lesions in different subsets of     patients (STEMI, NSTEMI and stable/unstable angina) by use of optical coherence tomography     (OCT) and intravascular ultrasound tissue characterisation (IVUS-TC).   "
245685|NCT01065532|"     Different healing responses after treatment of bare metal stent restenosis with implantation     of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting     SeQuent Please balloon (BBraun): an optical coherence tomography study.      A prospective, single-centre, randomized clinical trial with clinical, angiographic and OCT     follow-up at 9 months.   "
245686|NCT01065545|"     The purpose of this study is to determine the side effects of the study drug, clofarabine,     when given by mouth to patients with acute myeloid leukemia (AML), in remission.   "
245687|NCT01065558|"     The purpose of this study is to determine the effects of ecopipam in patients with     Lesch-Nyhan Disease (LND). Ecopipam specifically blocks the actions of one chemical in the     brain that helps nerves talk to one another; ecopipam does this by stopping the chemical     (dopamine) from binding to one of its family of receptors (i.e, the D1 family). LND is a very     rare genetic disease. The sponsor is doing this study to find out what side effects ecopipam     causes in LND patients, and whether ecopipam may be able to relieve the self-injurious     behaviors seen in these patients.   "
245688|NCT01065571|"     The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free     interval in patients with ulcerative colitis.   "
245689|NCT01065584|"     In experimental and clinical settings it has been shown that transplant tolerance is     possible. It has been suggested that regulatory T cells play a beneficial role in the     establishment of tolerance. Calcineurin inhibitors may inhibit development of regulatory T     cells. However, the influence of calcineurin inhibitors on markers of transplant tolerance     has not been studied in patients undergoing liver transplantation. Currently the     investigators conduct a study to evaluate the safety and efficacy of a calcineurin inhibitor     free immunosuppression in patients undergoing liver transplantation. In this study     measurements of immune function and CD4+CD25high-Foxp3+-Il2/CD8+ status will also be     performed. In parallel these measurements should be compared to a group of patients     undergoing standard immunosuppression including calcineurin inhibitors.   "
245690|NCT01065597|"     This study involves pilot testing of a modified version of a proven treatment for mental     illness. The treatment, electroconvulsive therapy (ECT) is used to treat more than 100,000     Americans yearly. ECT is the most effective treatment for major depression, a disorder that     affects approximately 5 to 8 percent of the adult US population yearly. It is also an     effective treatment for mania and mixed mood states associated with bipolar disorder and     schizoaffective disorder.      The aim of ECT is to induce a seizure, which is thought to be responsible for both its     therapeutic and its adverse cognitive effects. The proposed modification consists of reducing     the ECT electrical stimulus dose below the amount necessary to induce seizures so that     adverse cognitive effects, such as confusion and memory problems, are minimized.      The investigators intend to determine whether ECT-related cognitive impairment can be reduced     without diminishing the therapeutic effect of ECT. In addition to distressing patients,     ECT-related cognitive impairment has significant public health consequences. These include     increased morbidity and mortality among severely ill individuals who refuse ECT due to     concern over its adverse cognitive effects as well as increased falls among the elderly     receiving ECT. Elderly patients are far more likely to receive ECT and are also more     vulnerable to ECT-related cognitive impairment. They often require hospitalization for ECT     and a longer hospital stay with greater spacing of treatments to minimize adverse cognitive     effects.      The hypothesis driving this research is that electrical brain stimulation applied in the same     manner as standard ECT, but at a lower dose, can have therapeutic effects and fewer adverse     cognitive effects without inducing seizures. This hypothesis is based on the following: 1)     the investigators clinical experience of patients who have improved with ECT despite having     only one or no seizure, 2) animal studies showing that electrical brain stimulation can     induce antidepressant like effects in animals without inducing seizures, 3) reports from the     1950s that subconvulsive and nonconvulsive electrotherapy was effective for some     patients, and 4) the recent approval by the US Food and Drug Administration of the use of     transcranial magnetic stimulation --a technique that uses a magnet to induce an electrical     current in the brain without inducing seizures--for treatment of medication resistant major     depression.      The primary aim of the research is to conduct a proof of concept, open trial investigating     the therapeutic efficacy and safety of nonconvulsive electrotherapy (NET). The investigators     plan to enroll 16 subjects, which is the minimum number of subjects needed to show that the     therapeutic effect of NET is better than would be expected of placebo. If the investigators     show that the therapeutic effect of NET exceeds that expected of placebo and does not induce     significant cognitive impairment, then the investigators will go on to propose a blind,     randomized, controlled clinical trial that more definitively tests the investigators'     hypothesis. The investigators would use the information gathered from the pilot trial to     estimate the number of subjects needed to definitively test the efficacy and safety of NET.      The secondary aim of the study is to find out whether NET affects blood levels of     brain-derived neurotrophic factor (BDNF). BDNF is a substance that is important to the     nervous system and may be related to how treatments like ECT or possibly NET improve     symptoms. The investigators would draw a blood sample before and after NET treatment to     assess this.   "
245693|NCT01065636|"     Obesity causes frailty in obese older adults by exacerbating the age-related decline in     physical function. However, appropriate management of obesity in older adults is     controversial. Weight loss without exercise could worsen frailty by accelerating the usual     age-related decline in muscle and bone mass that leads to sarcopenia and osteopenia,     respectively. Because of the important problem of frailty in obese older adults, it is     important to determine the most efficacious approach in reducing, or even reversing frailty     in this population. The primary objective of this proposal is to evaluate which distinct type     of physical exercise (resistance, aerobic, or combined resistance + aerobic) is most     efficacious in preventing the weight-loss-induced reduction in muscle and bone mass and     reversing frailty in obese older adults.   "
245694|NCT01065649|"     Patients with nonerosive reflux disease (NERD) are less responsive to standard treatment with     proton pump inhibitors. The hypothesis of this study was that nortriptyline in analgesic     doses may decrease heartburn perception and its corresponding cortical activity measured by     magnetic resonance image. Therefore, the aim of this study was to assess the cortical     representation of heartburn in patients with NERD under treatment with nortriptyline and     placebo.   "
245695|NCT01065662|"     The purpose of this research study is to determine the safety of the combination of the two     drugs cediranib and temsirolimus and the highest doses of these two drugs that can be given     in combination to people safely. Cediranib is a drug that may stop blood supply to the tumor     and therefore help keep cancer cells from growing. Temsirolimus is a drug that may stop     cancer cells from growing. These drugs have been used in other research studies in ovarian     and kidney cancer and these studies suggest that these drugs may help to keep cancer from     growing in this research study.   "
245731|NCT01066143|"     The 12 week clinical trial of Seroquel in Generalized Anxiety Disorder (GAD) patients will be     combined with fMRI experiments.   "
245732|NCT01066156|"     This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in     PTSD.   "
245733|NCT01066169|"     As recommended by the Dutch Health Council, certain risk groups and health care workers in     The Netherlands were vaccinated to prevent morbidity due to pandemic influenza A/H1N1. Adults     were vaccinated twice with the monovalent influenza A/California/2009(H1N1) MF59-adjuvanted     surface-antigen vaccine Focetria® (Novartis). The vaccination campaign was executed by     general practitioners.      The aim of the study is to verify whether HIV-infected individuals generate an adequate     immune response after the first and after the second vaccination.   "
245799|NCT01067027|"     It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed     infants with colic.   "
245696|NCT01065675|"     Up to 50% of medication errors and 20% of adverse drug reactions (ADRs) in the hospital     setting are estimated to be related to communication issues regarding patient medications at     various transition points of care from admission to discharge. The Joint Commission (TJC)     requires accurate and complete medication reconciliation occur at each transition point     throughout hospitalization. Evidence from NQF demonstrates pharmacists (RPh) are the most     effective medication management team leaders in the implementation of medication management     practices and design of medication error reduction strategies; medication reconciliation is     one of the five safety objectives pharmacists are recommended to lead. In addition, the     Massachusetts Coalition for the Prevention of Medical Errors states strong evidence supports     the use of pharmacy technicians (CPhT) in conjunction with pharmacists in completing accurate     medication histories.      WMC nurses (RN) currently are involved in the medication reconciliation process. In 2009, a     Medication Use Evaluation (MUE) of Medication Reconciliation Accuracy found a 67% medication     error rate on admission determined by comparing the nurse-obtained medication history to the     pharmacist-obtained medication history. The number of home medications identified by the     pharmacist compared to the nurse was 411 versus 312 (p<0.0001). The total percentage of     medication errors prevented by the pharmacist was 66.2. Using the VA Healthcare Failure Mode     Effects Analysis - HFMEA™ Hazard Scoring Matrix, 3 independent pharmacist reviewers found     that 18% of patients interviewed had a score greater than 7, and 3 patients had a score of 12     (major/probable), if the discrepancies would not have been identified and corrected by the     pharmacist conducting the admission medication reconciliation audit. The same patients'     discharge medication reconciliation and discharge medication lists were retrospectively     reviewed for the MUE, and the total percentage of patients with medication errors on     discharge was 43%.   "
245697|NCT01065688|"     The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I     reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction     (R-Y) in patients with gastric cancer.   "
245698|NCT01065701|"     Intranasal dexmedetomidine has shown to be an effective sedative when used prior to     anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in     previous study and it produced satisfactory sedation in more than 50% of the children at the     time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg     with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain     satisfactory sedation prior to anaesthetic induction when higher dose is used.   "
245699|NCT01065714|"     While the repair of the epidermal barrier in atopic dermatitis is of major importance in the     treatment of atopic dermatitis, most of the vehicles used may actually cause a worsening of     an impaired epidermal barrier. Hydrogel vehicle is anecdotally known to be moisturizing and     hydrating.This study will compare the use of Hydrogel vehicle and Eucerin Lotion in     maintaining the epidermal barrier in subjects with atopic dermatitis.   "
245700|NCT01065727|"     Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone     followed by immunomodulator) in the management of aggressive remitting multiple sclerosis   "
245701|NCT01065740|"     Peripheral arterial disease (PAD) is a frequent and serious chronic disease witch is     undertreated. The recommended management of PAD include pharmacological approach and     lifestyle modifications. Patient education help to reach this outcome. Our study propose to     compare patient education management with physical activity coaching to usual care.   "
245702|NCT01065753|"     Central obesity, core of metabolic syndrome, has been recognized as one of the rooting     factors for development of diabetes and cardiovascular disease. Although efforts have been     devoted to the studies of central obesity and/or metabolic syndrome, much remained unknown as     to how obesity influences cellular as well as cardiac functions, what is the central     regulation of one's body weight.      Weight loss is an undisputed way to improve cardiovascular and metabolic disorders in obese     individuals. Previous studies have demonstrated that weight loss by 5% of initial weight     universally provide substantial benefits in these subjects. However, there are little     integrated research teams, composed of different disciplines, share common weight reduction     program to look at different aspects of weight reduction in non-diabetic individuals with     metabolic syndrome. The significances of this proposal we plan to target, namely Rho kinase     activity from peripheral leukocyte, several cardiac functions measured by noninvasive     technique (VP-2000) and MRI, circulating brain-derived neurotrophic factors (BDNF) levels,     are fully explained detailed in each sub-proposal.      In order to accomplish this integrated proposal, we will form research teams including     endocrinologists, cardiologists, radiologists, and a coordinating data center. We pan to     recruit 40 non-diabetic individuals with metabolic syndrome to participate this 12-16 weeks     weight reduction program. Twenty-five age, sex matched non-diabetes lean will be served as     controls. Oral glucose tolerance test, fasting blood obtained, noninvasive vascular and MRI     examinations will be applied before and after weight reduction program in those achieving at     least 5% loss of initial weight.      In summary, this study will investigate the effects of weight loss on (1) Rho kinase activity     obtained from peripheral leukocyte; (2). Aortic stiffness, central aortic pressure and     hemodynamic by a noninvasive vascular profiling system (VP-2000); (3) Brain function     specifically reflecting by circulating BDNF; (4). Aortic elastic properties and left     ventricular function by using MRI examinations, in non-diabetic individuals of metabolic     syndrome.   "
245703|NCT01065766|"     This survey is conducted for preparing application materials for re-examination under the     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the     clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and     efficacy information according to the Re-examination Regulation for New Drugs.   "
245781|NCT01066793|"     This observational study will assess predictors of early on-treatment and sustained     virological response in treatment-naïve patients with chronic hepatitis C initiated on     treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data     will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the     end of treatment. Target sample size is <2000.   "
245705|NCT01065792|"     This survey is conducted for preparing application materials for re-examination under the     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the     clinical usefulness of STOCRIN through collecting the safety and efficacy information     according to the Re-examination Regulation for New Drugs.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
245706|NCT01065805|"     The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images.     Tumour growth rate is a useful indicator of tumour aggression and response to treatment.     Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to     anticancer treatment.   "
245734|NCT01066182|"     The purpose of this study is to determine whether DHA (in a daily dose of 600 mg.) will     improve the behaviour and learning of normal children aged 7-9 years in mainstream state     schools who are underperforming according to nationally standardized tests.   "
245735|NCT01066195|"     Pemetrexed was known to be effective to pulmonary adenocarcinoma and gefitinib was known to     be more effective to non-small cell lung cancer (NSCLC) patients with clinical     characteristics such as adenocarcinoma, never smoker and female.      The investigators try to evaluate which drug (pemetrexed vs gefitinib) is more efficious to     NSCLC patients with clinical characteristics such as adenocarcinoma and never smoking history     as second- or further-line therapy.   "
245707|NCT01065818|"     The goal of this research study is to learn if a new type of PET scan (18F-FLT) can help to     better detect changes of tumor growth rate (or how active) in esophagus cancer. Researchers     will study at what time during treatment the 18F-FLT PET scan should be given to get the best     results.      A Positron Emission Tomography (PET) scan is a type of scan that uses a radioactive solution     to locate cancer cells inside the body. Using the PET scan, doctors can locate solid tumors     and collect information about how active the cancer cells are.      For this study, a new type of solution, [F-18] fluoro-L-thymidine (FLT), will be used. FLT     can detect actively growing tumor, and researchers hope that FLT may be able to help provide     information about how well esophagus cancer treatment is working. This information could be     used to help predict if the cancer will respond to treatment.      All enrolled subjects will receive 4D-PET/ CT imaging at pre-chemoradiotherapy (CRT) and     post-CRT prior to the esophagectomy. At each time of the 4D-PET/ CT procedure, the subject     will receive an injection of FLT which is an investigational pharmaceutical labeled with     radioactive fluorine. Each scan process might take 45 to 60 minutes. The 4DPET/ CT imaging at     pre-CRT and at post-CRT will be compared and evaluated with the pathological assessment of     the surgical specimens.      Participation in this pilot study will not change the patients normal chemotherapy, radiation     treatment, and surgery recommended the patients physician as parts of their standard of care.   "
245708|NCT01065831|"     The purpose of this study is to test the effect of a church-based lifestyle intervention on     blood pressure reduction in 400 hypertensive blacks (BP> 140/90 mm hg).   "
245709|NCT01065844|"     The purpose of this study is to evaluate the FDA-approved drug nelfinavir (NFV) as an     oncologic agent for adenoid cystic cancers of the head and neck.      Specifically, subjects will be asked to take 1250 mg twice daily and follow-up with their     medical oncologist as clinically indicated while taking this medication.      Subjects would be evaluated for quality of life issues utilizing the EORTC QLQ-C30 2-page     questionnaire.      Subjects would also be evaluated clinically by the oncologist to determine if the NFV was     having an anti-neoplastic effect.      The study remains unfunded. Therefore, potential subjects must be willing to provide     self-travel to study site. This study requires a screening visit, initial study visit, and     monthly follow-up. Subjects are not reimbursed for time, travel, or physician costs.   "
245710|NCT01065857|"     The purpose of this study is to determine any significant differences in the efficacy and     acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of     gastrointestinal subjects undergoing a colon examination.   "
245711|NCT01065870|"     This study is for patients with locally advanced pancreatic cancer (cancer that involves the     local blood vessels so it cannot be removed without cutting major blood vessels) that cannot     be treated with surgery. The purpose of this study is to assess the safety and benefit of 6     three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and     docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only     venous involvement. Group II patients have arterial involvement and may also have venous     involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of     radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation     treatment, participants may be able to have surgery to remove any remaining pancreatic     cancer.   "
245712|NCT01065883|"     This study compares an asthma self-management intervention, delivered to the family and     tailored to their needs and cultural beliefs, to standard asthma education on two risk     factors for asthma exacerbations in high-risk Puerto Rican children in high school. The     self-management intervention will be a series of home visits provided by Puerto Rican     community health workers. During home visits, the family will be educated using a standard     asthma Core Curriculum which is tailored to individual needs, strengths, and beliefs.     Specific Aim 1 is to test the ability of this tailored community health worker     self-management intervention to reduce home asthma triggers and increase medication adherence     in Puerto Rican adolescents with asthma. Specific Aim 2 is to test if any changes in triggers     and adherence associated with this intervention are sustained 8 months after the completion     of the active intervention. Another goal of the study is to build community capacity for     asthma management in the target high-risk community.   "
245713|NCT01065896|"     Although conventional risk factors for coronary heart disease (CHD) have been identified and     routinely used to determine risk for CHD in the general population, a systematic approach to     determine population-specific risk for CHD has not been performed prospectively in those with     SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages than in     the able-bodied population. Conventional risk factors for CHD are high serum concentrations     of low-density lipoprotein (LDL), low serum concentrations of high-density lipoprotein (HDL),     diabetes mellitus (DM), positive smoking history, and positive family history of premature     CHD.      Coronary calcification (CAC) is a commonly occurring phenomenon that does not necessarily     indicate significant obstructive disease. Studies have shown that a strong association exists     between coronary calcification and coronary heart disease. The purpose of this study is to     compare the CAC scores in persons with SCI with a historical control group of able-bodied     persons from a national data base who will be matched for conventional risk factors for     coronary artery disease (CAD) and to determine the relationship between CAC scores and     conventional and emerging risk factors for CAD.   "
245866|NCT01073306|"     Dengue viruses can cause dengue fever and other serious health conditions, primarily     affecting people living in tropical regions of the world. This study will test whether a     vaccine developed to prevent infection with dengue virus type 2 causes a response in people's     immune system and is safe.   "
245744|NCT01066312|"     Manual Muscle Testing (MMT) practiced by over a million practitioners worldwide. However,     it's accuracy under varying levels of blindness has not yet been considered. This study will     test this accuracy.      Study Hypothesis: MMT can accurately distinguish congruent from incongruent statements. Also,     the accuracy of MMT is positively correlated with practitioner experience.   "
245745|NCT01066325|"     The objectives of this study are to investigate if Neuro Emotional Technique (NET) will     impact back and leg flexibility over both the short-term and the long-term.      It is hypothesized that NET will improve flexibility and that these changes are durable.   "
245800|NCT01067053|"     The purpose of this study is to determine whether bevacizumab, capecitabine and oxaliplatin     are an effective and safe first line of treatment for elderly patients with metastatic     colorectal adenocarcinoma.   "
245714|NCT01065909|"     Primary objective shared by the 3 registries : Describe the different pharmacotherapeutic     management in patients :        -  DB (Diabetes): with type 2 diabetes, treated with oral and / or injectable antidiabetics        -  CP (Chronic Pain): with any disease leading to chronic pain (lasting for more than 3          months)        -  AF (Atrial Fibrillation): with ongoing AF or AF diagnosed within 12 months before          enrollment      Secondary objectives shared by the 3 observatories:        -  Describe the occurrence of clinical events, hospitalizations and death, according to the          different medical care conditions, and analyze their predicting factors        -  Estimate the resources consumption according to the medical and non medical management          of these patients,        -  Analyze the impact of some factors (patient's cognitive status, autonomy, renal function          ...) on the current practice      Secondary objectives specific shared by DB and AF registries :      - Analyze the geriatric pharmaco-genetic aspects      Specific secondary objectives for each observatory :        -  DB : Describe HbA1c level, percentage of responders and body weight evolution according          to the different medical care conditions        -  CP : Evaluate pain consequences on Daily Living Activities and patient autonomy   "
245715|NCT01065935|"     To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung     transplant patients   "
245716|NCT01065948|"     The goal of this clinical research study is to learn about a new minimally invasive glucose     monitoring device called Fluorescence Affinity Sensor (FAS). In this study, the FAS will be     used to determine its effectiveness for glucose monitoring. Researchers want to find out how     the device performs at two different body sites (forearm and abdomen) over 4 hours. The     safety and comfort level of the device will also be studied.   "
245717|NCT01065961|"     Anterior cervical discectomy and fusion with or without decompression is a well-established     surgical treatment for spine patients with the appropriate indications. Anterior approach     involves some retraction that affect the midline structures of the anterior neck. Irritation     and swelling may result, leading to postoperative dysphagia and the less common but     critically important occurrence of postoperative airway compromise. Steroids given     intraoperatively may reduce the incidence of these adverse outcomes by reducing the degree of     swelling within the anterior neck subsequent to local surgical tissue trauma.      The investigators hypothesize that the use of steroids intraoperatively provides a     significant benefit to the patient, in terms of reduced incidence of dysphagia and airway     compromise.   "
245718|NCT01065974|"     The purpose of this study is to compare standard Behavior Therapy (BT), BT plus Meal     Replacements (MR) and a condition focusing on the nutritional control of body weight     (Nutritrol) on weight loss, weight loss maintenance, nutritional composition of the diet and     psychosocial outcomes. A second aim is to determine the degree to which the specific targets     of the experimental interventions do in fact change in the anticipated direction during the     intervention and to evaluate whether such changes might account for improvements in weight     loss maintenance. This study is important because it could provide the first evidence that     the current standard of care for obesity lifestyle treatment could be improved by the     addition of MRs or a program of comprehensive nutritional change.   "
245719|NCT01065987|"     The purpose of this bioequivalence study is to compare the test tizanidine Hydrochloride 4mg     tablets of Dr.Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in     healthy adult subjects under fed conditions.   "
245720|NCT01066000|"     This open-label single-arm study will evaluate the efficacy, safety and tolerability of     methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in     patients with chronic renal anaemia. Patients will receive methoxy polyethylene     glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or     200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose     adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24     weeks. The target sample size is 50-100 patients.   "
245721|NCT01066013|"     The purpose of this pilot study is to assess the impact of an antibiotic de-escalation     strategy on the clinical outcomes (clinical cure or improvement) of medical patients related     to the usage of of broad-spectrum antimicrobial agents.   "
245722|NCT01066026|"     The purpose of this study was to assess the safety and efficacy of a new metallic cannula to     inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard     needle.   "
245723|NCT01066039|"     This is a 24-week, prospective, multicenter, open-label, single-arm study to assess the     effect of bisoprolol on glycemic level in Type 2 diabetes mellitus (T2DM) controlled subjects     with hypertension. The hypothesis of study is that there is no change in glycemic level and     lipid metabolism as determined by glycosylated hemoglobin (HbA1c) using bisoprolol in T2DM     subjects with suboptimal blood pressure (BP) control.   "
245724|NCT01066052|"     This study was conducted to evaluate the efficacy and safety of recombinant human growth     hormone (r-hGH) treatment in young girls with Turner Syndrome.   "
245725|NCT01066065|"     The advent of new antiretroviral drugs improved the management of HIV naive patients in terms     of efficacy. However, the long term metabolic profile of this drugs has not yet been compared     and associations between new antiretrovirals and cardiovascular events remains controversial.      Moreover, the better tolerability and easy dosage of this new drugs might hypothetically     influence adherence and QOL of HIV patients.   "
245726|NCT01066078|"     This study used an external endocardial acceleration sensor (sonR sensor), placed on the     patient's chest, to time the closure of aortic and mitral valves, and compared its     performance with echocardiography.   "
245727|NCT01066091|"     The nature of dietary lipids, age and perivisceral adiposity could alter the postprandial     inflammatory response. It is supposed that there is a relationship between the postprandial     inflammatory response and the repartition of fat and lean mass, which could partially explain     the muscle mass loss with age.      The aim of this study is to compare the inflammatory response of a normal meal or high fat     meal (from different fatty acids sources) between young lean and young obese and aged lean     and aged obese men.   "
245867|NCT01073319|"     To study the effects of treatment with rivastigmine on craving produced by experimental     administration of methamphetamine.   "
249412|NCT01120639|"     The purpose of this study is to investigate the safety and effectiveness of a combination     treatment for glioblastoma multiforme utilizing radiotherapy with the FDA approved     chemotherapy drug temozolomide   "
245736|NCT01066208|"     Vasculitis is group of diseases where inflammation of blood vessels is the common feature.     Patients typically present with fever, fatigue, weakness and muscle and joint aches. These     symptoms are very common among many different diseases, not just vasculitis. A clustering of     other symptoms, physical examination findings, blood tests, radiology and biopsy help make     the diagnosis. There are currently no criteria to help doctors make a diagnosis of vasculitis     when a patient presents with these non specific symptoms and they are reliant on previous     experience and disease definitions. One of the aims of this project is to develop diagnostic     criteria for the primary systemic vasculitides (granulomatosis with polyangiitis (Wegener's),     microscopic polyangiitis, Churg Strauss syndrome, polyarteritis nodosa, giant cell arteritis,     Takayasu arteritis). We, the investigators, will do this by studying a large group of     patients with vasculitis and comparing them to a large group of patients that present in a     similar way, but do not have vasculitis. By comparing the 2 groups we will create a list of     items to differentiate between vasculitis and 'vasculitis mimics'.      We also aim to update the current classification criteria. Classification criteria are used     to group patients into different types of vasculitis, once a diagnosis of vasculitis has been     made, and are useful for studying patients in clinical trials with similar or identical     diseases. The current classification criteria (American college of Rheumatology 1990     criteria) were developed 20 years ago, before the availability of some important diagnostic     tests (e.g. antineutrophil cytoplasmic antibodies [ANCA]), and are now not consistent with     some of the current disease definitions. Therefore to progress future research in vasculitis,     it is important that the classification criteria are updated. We will recruit 260 patients     with each of the 6 types of vasculitis and compare them with 1300 controls (patients with the     5 other types of vasculitis), in order to determine the optimal combination of symptoms,     signs and investigations that classify each person into the appropriate group.   "
245737|NCT01066221|"     The purpose of this study is to establish which of the following tests perform best in     diagnosing clostridium difficile. PCR, Enzyme Immunoassays (EIA) and C. difficile cytotoxin     assay (CTA).   "
245738|NCT01066234|"     This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely     resected microscopic N2 NSCLC   "
245739|NCT01066247|"     Blood pressure drop following spinal anesthesia is connected with sympathetic/parasympathetic     activity which may be determinated by Heart Rate Variability (HRV) assessment. Sympathetic     predomination expressed as LF/HF ratio above 2.5 is strongly connected with deeper blood     pressure fall. As drugs given for premedication may have impact on HRV variables, the     investigators would like to determine if pharmacological premedication may modify hemodynamic     changes following spinal blockade. Two drugs will be compared - midazolam which is known to     lead to increase in LF/HF ratio and morphine - opioid which provokes opposite effect.   "
245740|NCT01066260|"     Probiotic administration is associated with health benefits on gut barrier integrity and     immunological functions of the gastrointestinal tract. Recently, probiotic consumption was     proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al.     2009). Changes in energy metabolism might be involved in the effects of probiotics on weight     control.      The objective of this study was to assess the efficacy of the consumption of a probiotic     formulation on energy balance in overweight subjects.   "
245741|NCT01066273|"     Studies have established that the somatosensory system of the upper cervical region and head     can be intimately involved in tinnitus. Tinnitus can arise directly from a disorder of the     head and upper neck via the somatosensory system. Our clinical experience and review of     reports of various types of treatments support the hypothesis that treatment modalities     involving the somatosensory system can benefit individuals whose tinnitus is likely on a     somatosensory basis, namely people with symmetric hearing thresholds but asymmetric widely     fluctuating tinnitus. However these previous studies did not (a) limit their treatment     population to only people with tinnitus on a somatosensory basis and (b) did not assess their     results by considering this tinnitus subpopulation separately from the entire group of     tinnitus subjects they treated. Hence, the purpose of this study is to re-assess these     treatments by targeting people whose audiograms can not account for their tinnitus, such as     individuals with symmetric hearing thresholds but asymmetric widely fluctuating tinnitus   "
245935|NCT01074554|"     Growing research from independent laboratories provide an association between mycobacteria     and sarcoidosis. More recent immunologic and molecular studies demonstrate immune responses     to mycobacteria virulence factors. The purpose of this study is to assess if administration     of anti-mycobacterial drug therapy will aid in resolution of cutaneous sarcoidosis lesions.   "
245742|NCT01066286|"     Core binding factor (CBF) positive acute myeloid leukemia (AML) consist of 15% of patients in     overall AML, expected to harbor a favorable prognosis. However, around a half of cases     relapses. Accordingly, more sophisticated classification in CBF positive AMLs is essential to     achieve further improvement in the treatment outcome. The current study is designed to     evaluate CBF positive AML patients with genome-wide SNP array and KIT mutation study in CBF     positive AML patients diagnosed at the Samsung Medical Center and Hwasun Chonnam National     University Hospital, Korea between 1994 and 2008.        1. Construction of the CBF positive AML patient cohort: clinical database establishment          (including treatment outcomes and prognosis) and extraction/storage of tumor cell DNAs          from marrow samples, then processing of Affymetrix SNP array 6.0.        2. Construction of prognostic predictive model using pharmacogenomics with the results of          genotypes and copy number variations (CNVs).        3. Detection of hidden microscopic cytogenetic lesions with SNP array technique, and          correlation with clinical outcomes in CBF positive AML.        4. Detection of KIT, FLT3/ITD, and NPM1 gene mutation and its correlation with clinical          outcomes in CBF positive AML.      The current study attempts to analyze genetic data of core binding factor (CBF) positive     acute myeloid leukemia (AML) using genome wide SNP array technique with tumor DNAs collected     at the time of diagnosis.        1. To detect microcytogenetic lesions and will analyze its prognostic significance        2. To analyze genome-wide genotypes and copy number variations (CNVs) using pharmacogenetic          approach and will construct a prognostic predictive model        3. To detect KIT, FLT3/ITD and NPM1 mutation and evaluate its prognostic significance. The          present study will establish individualized therapy for CBF positive AML, will provide a          basis for molecular marker guided clinical trial in CBF positive AML.   "
245743|NCT01066299|"     Oxytocin (OXT) is currently regarded as a crucial neuropeptide in the mediation of various     human social behaviors, e.g. social affiliation, social recognition, and the modulation of     anxiety, mood, and aggression. An impairment of social behavior, emotional regulation as well     as increased stress reactions are characteristic of several psychiatric conditions, including     schizophrenia, social anxiety and PTSD, in which there is also some evidence for OXT     dysfunction. The startle reflex is a basic defensive reaction that can be modulated by     emotional stimuli. The investigation of the startle reflex and of its modulation is a     well-validated method to test stress reactions and emotional regulation. These processes are     impaired in the same psychiatric diseases, in which OXT dysfunction was evidenced. Although     previous animal studies showed that the dysfunction of brain OXT systems might be implicated     in startle reflex and in its modulation, no study has been performed yet in human that     investigated the influence of OXT administration on the startle response and on its affective     modulation. A first aim of this study is to investigate the influence of OXT on stress     reactivity and emotional modulation in healthy humans. A second aim is to develop a method     for the investigation of anxiety disorders. Fifty male healthy participants will be tested     using a randomized double-blind placebo-controlled cross-over design in two occasions; once     with administration of 24 IU OXT, and once with placebo using nasal sprays while performing a     computer-based experiment, in which emotional pictures and auditory startle probes are     presented. We will measure the subject's subjective ratings of the pictures as well as the     facial EMG activation, heart rate and electrodermal activation throughout the study. This     project offers a unique opportunity to study the relationship between the OXT system and     basic motivational and emotional behaviors. The investigation of these mechanisms is in turn     greatly worthwhile, not only for understanding of the neurochemical and physiological     processes involved in emotional regulation, but also for the comprehension of the     neuroendocrine and neurophysiological mechanismsunderlying anxiety disorders. In the long     term, it could open the possibilities of OXT as a psychobiological therapeutics of     psychiatric disorders.   "
245756|NCT01066468|"     This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to <4     years of age to help develop dosing regimens   "
245746|NCT01066338|"     The most reliable prognostic marker of acute myeloid leukemia(AML) is cytogenetics by     karyotyping. According to cytogenetic results, the patients with AML are classified as     better, intermediate and poor prognosis groups. The normal karyotype AML was reported in     about 50% of all AML and classified as intermediate risk group. However, the patients with     normal karyotype AML showed various prognosis. Therefore, the further studies about subgroup     analysis of normal karyotype AML are needed. Recently, the understandings of human genome     polypmorphism using SNP array have been accumulated. However, the advanced researches for     clinical application are not enough.      The study design is a retrospective and single-center study. The patients with normal     karyotyping AML who were diagnosed from 1994 to 2008 at Samsung Medical Center (South Korea)     will be enrolled. The stored bone marrow samples of enrolled patients are used for genome     wide scanning by SNP array.      The purpose of present study is to develop predictive pharmacogenemic biomarkers model     associated wit clinical outcomes including efficacy and toxicity in patients with AML with     normal karyotype treated with chemotherapy using pharmacogenetic SNP array. And secondly, to     develop enrichment clinical trial based on predictive pharmacogenomic model.   "
245747|NCT01066351|"     The purpose of this study is to demonstrate the efficacy of erythropoietin for prevention     acute kidney injury in CKD patients undergoing cardiac surgery.   "
245748|NCT01066364|"     The purpose of the study is to see if the drug colesevelam is a potential treatment for     Nonalcoholic Steatohepatitis(NASH).   "
245749|NCT01066377|"     Ageing dramatically affects immune function; this phenomenon is known as immunosenescence and     partly explains the increased susceptibility for infection in older individuals. Vaccination     is recommended to protect older people against influenza, but immunosenescence also reduces     the efficacy of vaccination. Probiotics are beneficial bacteria, which can be consumed and     which have a long and safe record of use in humans. Often they are taken together with     prebiotics, which are carbohydrates that provide a food source for the beneficial bacteria     when they reach the lower gut. There is particular interest in the positive influences of     pre- and probiotics in older people, who are subject to alteration in gut microflora     composition as well as immunosenescence.      The PRIMAGE (Probiotics, immunity and ageing) study will examine the effect of a prebiotic     and probiotic mix on the immune response to influenza vaccination in young and older     subjects, and is funded by BBSRC DRINC. It will involve 60 young (18-35y) and 60 older     (65-85y) subjects recruited from the local Reading community. Participants will take a pre-     and probiotic mixture or a placebo for a total of 8 weeks. The probiotic is not currently     commercially produced, but has been demonstrated to have particular ecological fitness and     anti-pathogenic effects in the gastrointestinal tract in old age. A suitable prebiotic will     be selected on the basis of ability to promote optimal growth and survival of this probiotic.     After 4 weeks on the treatment, the subjects will receive an influenza vaccination. Blood,     saliva and stool samples will be taken before treatment, and at 4, 6 and 8 weeks after     commencement. The samples taken at 6 and 8 weeks will be used to assess the immune response     to the vaccination. A wide range of immune parameters will be assessed, taking into account     the age-related shifts in immune cell populations.   "
245782|NCT01066806|"     SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to     recommended levels with dairy foods in adolescent females with habitually low calcium intake     and above-the-median body mass index (BMI) for sex and age will decrease body fat gain     compared to similar females who continue their low calcium intake. .      HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume     dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in     percent body fat, as measured by dual energy absorptiometry, during one year than     post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.   "
245936|NCT01074567|"     The purpose of this study is to examine the efficacy of dimethylsulphoxide (DMSO) cocktail in     patients with interstitial cystitis during the treatment period (12 weeks) and after it (at 6     weeks, 3, 6 and 12 month).   "
245750|NCT01066390|"     This phase I study plan is divided in the following four phases:        -  Eligibility Screen Phase (week -4 to -1): Following written informed consent patients          with metastatic melanoma (AJCC stage III/IV with unresectable disease) will undergo an          eligibility screen (incl. blood analysis and PET/CT-scan).        -  TriMix-DC Vaccine Manufacturing Phase (week I to IV): eligible patients will undergo a          leucapheresis (15 liter of venous blood) for the preparation of autologous TriMix-DC          vaccine. Vaccine preparations will be manufactured and quality-controlled (during an          interval of 4 weeks following the leucapheresis) and released for patient administration          if the TriMix-DC preparation fulfills the predefined quality requirements.        -  TriMix-DC Vaccine Administration Phase (Week 1 to 24): 4 weeks after the leucapheresis          patients will initiate therapeutic vaccination with the TriMix-DC vaccine by IV and ID          administration. The vaccines will be administered at 4 different visits that will be          separated with an interval of 2 weeks. At each vaccination a total of 12.106 DC per          antigen will be administered.        -  Patients will be allocated to three different cohorts:             -  The first cohort will receive 10% of TriMix-DC by iv and 90% by id injection.             -  The second cohort 25% by iv and 75% by id injection.             -  The third cohort 50% by iv and 50% by id injection.        -  During the week following the administration of the fourth vaccine (= week 8), a          DTH-test and punch biopsy of the injection site will be performed as well as a second          leucapheresis (for the purpose of immuno-monitoring) and tumor evaluation (by PET-CT).        -  A fifth vaccine will be administered and a repeat tumor staging performed in week 16 (=          8w after the fourth vaccine).        -  End of study visit: Patients will perform an end of study visit 8 weeks after the          fifth vaccine (= week 24) as well as a new tumor evaluation (PET/CT).        -  Follow-up Phase: survival data will be obtained until 3 years after the initiation of          vaccine therapy or the time of death.   "
245751|NCT01066403|"     The objective of this study is to compare the modulation of pergolide, a D1/D2 receptor     agonist, to placebo in non-acute schizophrenic subjects under concomitant therapy with     atypical antipsychotics on specific PFC functions. Further aims are to assess the influence     of pergolide on psychopathology and extrapyramidal symptoms in comparison to placebo.   "
245752|NCT01066416|"     It is unknown whether surgical treatment of chronic sinusitis improves asthma control in     patients with poorly controlled asthma. This is a randomized trial of surgical plus medical     sinus therapy versus medical therapy alone.   "
245753|NCT01066429|"     Poor prognosis dufuse large B-cell lymphoma (DLBCL) represents 50% of all DLBCL with overall     cure rates ranging from 50-60% with modern dose-dense immunochemotherapy regimens such as     R-CHOP14. Using an alternative strategy, as infusional and dose-adjusted R-EPOCH, the     investigators have shown an 83% of complete responses (CR), with an estimated 5-year overall     survival (OS) rate of 75% (García-Suárez et al. British Journal of Haematology 2007,     136:276). Despite this improvement in outcome, the search for new treatment strategies should     continue. Therefore, compared with prior R-EPOCH the investigators decided to investigate     whether the introduction of dexamethasone (40 mg IV on days 1-5) in place of prednisone     (based upon data which demonstrated that the former was associated with enhanced Central     Nervious System penetration) and the reduction of treatment intervals from 3 to 2 weeks would     be feasible and might improve the outcome in this group of patients.   "
245754|NCT01066442|"     To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the     long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649     in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's     Disease.   "
245755|NCT01066455|"     The purpose of the research study is to evaluate different cardiac measures that are obtained     by echocardiographic tests in patients with muscular dystrophy.   "
245759|NCT01066507|"     The purpose of the study is the identification of amplification level in human breast tissue.     The imaging system is intended for diagnostic use as an aid to the pathologist in the     detection, counting and classification of Her2 FISH stained tissue samples.   "
245760|NCT01066520|"     The objective of this study is to determine the efficacy of Traumeel S (both ointment and     gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained     ankle.   "
245761|NCT01066533|"     The purpose of this study is to evaluate the response of human dental pulp to capping with     MTA and NEC by histology and immunohistochemistry, using fibronectin and tenascin as markers,     following 2 weeks and 8 weeks.   "
245762|NCT01066546|"     The purpose of this study is to evaluate the long-term safety and tolerability of dimebon in     subjects with moderate-to-severe Alzheimer's Disease.   "
245763|NCT01066559|"     The aim of this study is to improve the humoral immune response efficiency of hemodialyzed     patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model     of anti-HBV vaccination   "
245764|NCT01066572|"     This study aims to investigate the use of lisinopril to lower blood pressure in stroke     patients, pre-hospital, by research-trained paramedics.   "
245765|NCT01066585|"     The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective     treatment for head lice infestations.   "
245766|NCT01066598|"     The purpose of this study is to determine the efficacy of the combination of rituximab and     prednisone as initial therapy for chronic graft-versus-host disease (C-GVHD).   "
245767|NCT01066611|"     The purpose of this study is to determine the safety and effect of CAL-263 in subjects with     allergic rhinitis.   "
245783|NCT01066819|"     This observational study will assess predictors of early on-treatment and sustained     virological response in treatment-naïve patients with chronic hepatitis C initiated on     treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data     will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the     end of treatment. Target sample size is <2000.   "
245831|NCT01067456|"     The purpose of this research is to determine the efficiency of a single dual source computed     tomography (CT-DSCT) protocol to establish or exclude acute coronary syndrome (ACS),     pulmonary embolism (PE) or aortic dissection (AD) as compared to the individual protocols.     Endpoints aim to compare the rate of emergency department (ED) discharge, length of hospital     stay, the diagnostic imaging test utilization, and the costs between the comprehensive and     the standard protocol strategy in patients with undifferentiated chest discomfort or     shortness of breath with a component of chest discomfort.   "
245768|NCT01066624|"     Chemotherapy-induced oral mucositis is the inflammation of the oral mucous membranes, which     are tissues that line the mouth. Oral mucositis is caused when chemotherapy attacks and kills     the rapidly-dividing cells in the oral mucous membranes. This condition feels like sunburn     (or heartburn) on the mucous tissues, and often leads to sores in the mouth or on the tongue.     This can cause discomfort, pain, difficulties in eating, and a longer hospital stay. Several     therapies appear to either prevent or reduce the severity of mouth ulcers caused by     chemotherapy for multiple myeloma. Different strategies are used to try and prevent this     condition; a small number of trials found that some of these strategies may be effective.     None of the trials had compared head to head the use of saline solution (our standard of     care), cryotherapy (ice chips) and Caphosol in patients receiving high-dose melphalan.      The goal of this research study to evaluate the effectiveness of saline solution,     cryotherapy, Caphosol for the prevention of oral mucositis in patients with multiple myeloma     receiving high-dose chemotherapy followed by autologous hematopoietic stem cell     transplantation.      The researchers hope to learn if there are any differences among saline solution, cryotherapy     and Caphosol mouth rinse for the prevention of oral mucositis.   "
245769|NCT01066637|"     The primary purpose of this study is to measure the level of an enzyme in a patient's heart     called inducible nitric oxide synthase(iNOS) using Positron Emission Tomography (PET) imaging     with a radioactive tracer called 18F-NOS. These PET results will be compared to tissue     results obtained during routine endomyocardial heart biopsy. The enzyme iNOS produces nitric     oxide in inflammatory diseases such as acute heart transplant rejection, diabetes,     Alzheimer's and cancer. Thus, PET with the radioactive tracer 18F-NOS may be a useful tool     for detecting the early stages of these diseases. The safety of 18F-NOS during the study will     also be assessed. All PET imaging will be performed with a CTI/Siemens Biograph 40 PET/CT     scanner. Protocol was revised to add new imaging modality, Biograph mMR PET-MR scanner in     order to investigate new hardware and software in order to optimize scanning procedures in     order to refine image quality so that we can apply the findings to future standard clinical     scans and research imaging studies. Ten additional status-post OHT patients who are scheduled     for standard of care endomyocardial biopsy for allograft rejection surveillance will undergo     PET/MR imaging with [18F](+/-)NOS.   "
245770|NCT01066650|"     The TWENTE Study is a single center prospective single-blinded randomized study.     Randomization will involve the type of Drug-Eluting Stent (DES) used in study population.     Patients will be blinded to the type of DES they will receive. The general practitioner of     the patient will be requested not to disclose this information to the patient. Analysts who     perform the data analyses will be blinded to the type DES used as well.   "
245771|NCT01066663|"     In this research study we will start by looking for the highest dose of pyrimethamine that     can be given safely to CLL patients without severe or unmanageable side effects. This dose     will then be used for a larger Phase II study to assess the efficacy of pyrimethamine for the     treatment of CLL/SLL. Pyrimethamine is an antibiotic that is used for the treatment of     certain infections. Previous research studies have shown that pyrimethamine may target a     protein in tumor cells, called STAT3, which may be important for the growth of chronic     lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) cells. Pyrimethamine can kill     CLL/SLL cells in the laboratory, and we are therefore undertaking this study to assess     whether pyrimethamine will result in clinical benefit or tumor responses in CLL in patients.   "
245853|NCT01067755|"     To evaluate the role of the LungPoint VBN System in the bronchoscopic access to a target     location.      The evaluation will explore:        -  Ability of the system to guide a user to one or more target site(s)        -  Ease of use of the system (assessment of the user interface)        -  Incremental value brought by the use of the system to the successful completion of a          case.   "
245772|NCT01066676|"     Medical condition under investigation: Osteoarthritis of the hip or knee      Number of patients planned: 480 adult patients      Main objective: To evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg     powder for oral suspension compared to Ibuprofen 400 mg in patients with painful     osteoarthritis of the hip or knee      Secondary objectives: To compare the overall efficacy of Dexibuprofen Gebro 400 mg powder for     oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints     due to painful osteoarthritis of the hip or knee   "
245773|NCT01066689|"     Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a     composite TREATMENT FAILURE   "
245774|NCT01066702|"     This confirmatory study is a prospective randomized trial comparing the efficacy and safety     of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention     microfracture in the treatment of cartilage defects in the knee.   "
245775|NCT01066715|"     The study hypothesis is that XOMA 052 improves glycemic control in subjects with Type 2     Diabetes.      Study X052078 is designed to establish efficacious dose(s) for future studies based on     improvement in HbA1c.   "
245776|NCT01066728|"     The objective of the present proposed study is to discover whether, in the nursery setting,     administration of low concentration inhaled CO2 (0.8%) for a prolonged period (3 days) can     make breathing more regular with less apneic time than that observed with administration of     theophylline. The hypothesis to be tested is that inhalation of low concentration CO2 (0.8%)     will reduce apnea more effectively and will have fewer adverse side effects than     theophylline.   "
245777|NCT01066741|"     The purpose of this study is to evaluate the benefit of a mouthwash with a     phytopharmaceutical preparation, Homeodent®, compared to a mouthwash solution containing     sodium bicarbonate, for prevention of severe mucositis (grade ≥3, RTOG classification) in     patients receiving irradiation for oral cavity, oropharynx, hypopharynx or cavum cancer.      This is a phase III, controlled, randomized, single blind study. The estimated inclusion     period is approximately 24 months. The number of patients required in this monocentric study     is 330 (165 per arm).   "
245778|NCT01066754|"     Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg     Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets, Aventis Administered     as 1 x 180 mg Tablet in Healthy Subjects under Fasting Conditions   "
245779|NCT01066767|"     Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg     Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets aventis Administered     as      1 x 180 mg Tablet in Healthy Subjects under Fed Conditions   "
245780|NCT01066780|"     The purpose of this study is to collect information about how the new sound-processing     affects the ability to hear in everyday listening situations.   "
245808|NCT01067157|"     The purpose of the study is to determine the genetic influence on short-, middle- and     longterm effects of an inpatient lifestyle therapy program in overweight and obese children     and adolescents.   "
245784|NCT01066832|"     The primary objective of this multi-center, international, short term registry is to assess     clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent     restenosis at 6-9 months follow up. Clinical success defined as freedom from major adverse     cardiac events (MACE: death, myocardial infarction [MI], target lesion revascularization     [TLR]) and target vessel revascularization [TVR]) and stent thrombosis, both early and late     occurrences will be assessed.      In addition, a cohort of the registry will undergo angiographic follow up at 6-9 months to     assess in-stent and in-segment late loss and binary restenosis subsequent to paclitaxel     eluting balloon treatment for in-stent restenosis.      A prioi analysis will be comparison of the safety and efficacy of patients presenting with     drug-eluting stent in-stent restenosis to bare metal stent in-stent restenosis.   "
245785|NCT01066845|"     To investigate the long-term safety and effectiveness of Adcirca (tadalafil) in Pulmonary     Arterial Hypertension (PAH) patients in the clinical practice －focused topics－        1. To evaluate the incidence of adverse events for the patients with long-term use        2. To evaluate the incidence of adverse events of decreased blood pressure, bleeding          (including uterine hemorrhage), visual disturbance and sudden hearing loss.   "
245786|NCT01066858|"     The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an     anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and     while breastfeeding. The study will also look at the changes in overall health, bone health     and how the kidneys work in the infants of these women.   "
245787|NCT01066871|"     Several people all over the world suffer from cartilage injuries in the knee. Symptoms     include pain, joint swelling, and loss of function. Without repair, cartilage injury may     ultimately lead to osteoarthritis (OA). Natural healing is poor, and to date treatment is     available only for deep cartilage defects involving also the underlying bone. A promising     candidate for drug treatment of cartilage injury is sprifermin (AS902330), a recombinant form     of the human fibroblast growth factor (FGF) 18.      So far, the drug has been used in subjects with different stages of knee OA in two ongoing     studies without emerging safety issues following single and multiple intra-articular     injections of ascending doses. However, OA represents late-stage cartilage injury, where     repair might be difficult due to diffuse damage, reduced responsiveness of the cartilage,     and/or the involvement of other joint structures.      This clinical trial is meant to provide the proof of concept and to identify an efficacious     dose of sprifermin (AS902330) for the treatment of adult subjects with acute cartilage     injuries of the knee. The first subject for this trial was treated on the 19th of April 2010.   "
245788|NCT01066884|"     This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients     with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The     anticipated time on study treatment is until disease progression, and the target sample size     is 100-500 individuals.   "
245801|NCT01067066|"     The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI     287 that can be given in combination with Temodar (temozolomide) to patients with metastatic     melanoma.      The goal of the Phase II portion of this study is to learn if TPI 287, given in combination     with temozolomide, can control metastatic melanoma. The safety of this combination will also     be studied. NOTE: Study stopped before progressing to Phase II portion.   "
245789|NCT01066897|"     We hope to learn how a brain circuit that is important to the understanding of depression,     anhedonia and positive affect responds to a novel pharmaceutical treatment for depression and     related symptoms. Adults who have a diagnosis of major depression and are not completely     responsive to antidepressant medication will be sought out for participation; as will an     equal number of adults not suffering from the disorder. Those suffering from depression will     be given pramipexole, an investigational medication for eight weeks during which information     will be collected about mood, cognition, and brain function. Adults not suffering from     depression will also be evaluated with these measures.   "
245790|NCT01066910|"     The objective of this study is to test and evaluate the effectiveness of a parent-only     treatment for childhood obesity. This study provides state-of-the-art treatment for childhood     obesity. Parents and children will participate in treatment groups for 6 months. These     treatment groups include recommendations to decrease overall caloric intake (by increasing     fruits and vegetables), increasing physical activity, decreasing sedentary behavior and     changing the home food environment. We are currently implementing this treatment in the     Healthy Choices Program which is part of the Childhood Obesity Clinic at the University of     Minnesota. Len Epstein at the University of Buffalo has been publishing on this treatment     protocol for 30 years.   "
245791|NCT01066923|"     The purpose of this study is to determine if aspirin taken by firefighters prevents platelets     from becoming sticky when body temperature rises during work in protective clothing.   "
245792|NCT01066936|"     The objective of this study is to evaluate the bone ingrowth after implantation of the study     device. This study will also document any device-related surgical complications or adverse     radiographic observations. Improvement in pain, function, and health economic data will be     compared with improvements documented with other joint systems.   "
245793|NCT01066949|"     The aim of the proposed work is to conduct a randomized controlled trial (RCT) evaluation of     a behavior change intervention designed to enhance fluid-intake adherence (compliance) among     hemodialysis patients. Patient non-adherence (non-compliance) with fluid-intake restrictions     is a highly pervasive problem in the hemodialysis population with substantial consequences in     terms of increased patient morbidity and mortality. Given the prevalence and clinical     importance of adherence among ESRD patients, the design and evaluation of interventions to     improve patient adherence is critically important. Surprisingly, however, little such     empirical work has been conducted in this area.      The proposed RCT involves testing the efficacy of a behaviorally based, group-administered,     behavioral self regulation intervention designed to increase adherence to fluid intake     restrictions among hemodialysis patients. This structured intervention is designed to be     delivered by healthcare providers in a clinical setting to groups of 4-10 patients over     seven, one-hour weekly sessions. This study will compare the effect of the structured     intervention group with the effect of an educational and support group on fluid-intake     adherence in a sample of approximately 200 fluid non-adherent center hemodialysis patients     over a 26-week follow-up period. Both clinical (interdialysis session weight gain) and     self-report indices of fluid-intake adherence will be examined. We believe that the proposed     research is of potentially very high impact given the high prevalence and clear clinical     consequences of hemodialysis patient nonadherence and the potential for a relatively     low-cost, structured intervention to significantly reduce this type of maladaptive patient     behavior in the hemodialysis treatment context.   "
245794|NCT01066962|"     The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant     first-line treatment option in the years to come. The dual combination of boosted darunavir +     raltegravir is an innovative treatment option that combines two potent new antiretroviral     drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy     profile of this combination is promising. Moreover, this combination might have a better     tolerance profile and has the advantage of sparing the NRTI class.      In the context of tenofovir/emtricitabine currently being a reference backbone in first-line     antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir     may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.   "
245795|NCT01066975|"     Soldiers and recreational backpackers are often required to carry heavy loads on their body     during military operations or hiking. Despite the advances in backpack design, the loads     carried by soldiers still impose an extreme physiological strain (soft tissue deformation)     which frequently results in discomfort, pain,musculoskeletal injuries, and loss sensorimotor     function.      In the current study, characterization of the pressures, evaluation of the deformations of     the soft tissues, specifically the fat, muscles, Brachial plexus and subclavian vessels     applied on the shoulder while sitting with a heavy backpack will performed. The data acquired     in the current trials will be used for development of a finite element (FE) 3D shoulder     model. The purpose is to better understand the mechanical loads that are being transferred to     the underlying tissue below the shoulder straps during walking/marching with a backpack.     During the 2nd phase of this project, data collected during this research will be used to     develop gear that will alleviate the strain on the shoulders, prevent injury, and enhance     performance.      Hypothesis        -  High focal strain (hot-spots) on the shoulder tissue that are observed with the pressure          mapping will be observed also in the MR scans.        -  The strain at those hot-spots can be reduced by personal-geometry adjusted straps.      Volunteers      Five young (18-30 yrs), healthy, and fit males will participate in this study.      Trials design        1. MR Scans- The scan will be performed for analysis of personal shoulder anatomy, and will          be used for developing a 3D FE model. The sagittal view will be used to develop the 3D          model. The coronal and axial sectional views will be used to assess the deformations          applied on the shoulder tissue. The scan will then be repeated while carrying a 25 kg          standard commercial backpack while sitting in the same position, for the assessment of          shoulder girdle tissues deformations. Time estimation for each scan is 40 min (80 min          total). The subjects are not required to carry the backpack prior to those scans.        2. Static pressure measurement- each volunteer will be asked to sit for 30 seconds while          carrying the 25 kg backpack. During this session, pressure will be measured using a          pressure mapping pad (Sensor Products Inc., USA) placed between the shoulder strap and          the underlying tissue.      The maximal total participation time of each volunteer will be 2 hours total (inside and     outside the MR).      Data acquired in the current trials will be used for the development of a FE (finite element)     3D shoulder model. MR scans will be utilized for composing geometry and for the boundary     conditions assessment (strain magnitude). Pressure measurements will be used as boundary     conditions (stress magnitude).      MR scans and pressure measurements will be performed in the Sheba medical center facilities.   "
245796|NCT01066988|"     The purpose of this study is to evaluate the effects of an investigational lubricant eye drop     on tear film lipid layer thickness of dry eye patients.   "
245797|NCT01067001|"     To determine single-dose oral bioequivalence of Minocycline HCl Extended Release Tablets 135     mg manufactured by Amneal Pharmaceuticals Co.(I)Pvt. Ltd., India and SOLODYN® (minocycline     hydrochloride) Extended Release Tablets 135 mg Manufactured for Medicis, The Dermatology     Company, Scottsdale, AZ 85256, by Wellspring Pharmaceutical Canada Corp., Oakville, Ontario     L6H 1M5 in normal, healthy, adult, human subjects under fasting condition.   "
245798|NCT01067014|"     The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in     reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis     that requires surgery.   "
245803|NCT01067092|"     The MATCH study (Mexican-American Trial of Community Health Workers) tests the hypothesis     that the use of indigenous Community Health Workers (CHWs), recruited from the target     community and trained to provide culturally appropriate diabetes education, can promote     pro-active self-management among inner-city dwelling Mexican-Americans with Type 2 diabetes     mellitus. The study aims are to demonstrate that a CHW, compared to an attention control,     will: 1) result in improvement in short term physiologic outcomes (Hemoglobin A1c levels and     blood pressure), and 2) result in increased frequency of self-management behaviors (daily     self blood-glucose monitoring, medication adherence, adherence to diet and physical activity     recommendations). The study design is a single site, partially blinded, randomized controlled     trial of 144 patients with Type 2 diabetes mellitus.      Eligibility criteria include a diagnosis of Type 2 diabetes, residence in target community     areas in the Chicago area, and Mexican or Mexican-American ethnic heritage. Participants are     randomized to either an experimental group receiving 36 home visits over a two year period in     which a CHW delivered diabetes education and self-management skills training, or to an     attention control consisting of 36 bilingual diabetes education newsletters covering the same     curriculum as the CHWs. The curriculum covers recommended diabetes self-management behaviors     including glucose self-monitoring, responding to abnormal blood glucose levels, working     effectively with health care providers, medication adherence, foot care, daily physical     activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills     of self-monitoring, environmental restructuring, engagement of social support, stress     management, and problem-solving skills to facilitate the self-management activities.     Consistent delivery of the CHW intervention is documented by audiotapes and Documentation of     Intervention worksheets.   "
245804|NCT01067105|"     6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147).     Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered     once-daily in patients with Perennial Allergic Rhinitis.   "
245805|NCT01067118|"     The purpose of this study is to determine if the use of Linjeta(tm) insulin when compared to     Humalog will result in significantly lower episodes of hyperglycemia and hypoglycemia after a     breakfast meal.   "
245806|NCT01067131|"     Pevion Biotech develops a state-of-the-art vaccine against recurrent vulvovaginal candidiasis     (RVVC) caused by the pathogenic form of Candida albicans especially in pre-menopausal women     of childbearing age with a history of recurrent vulvovaginal candidiasis. This study is     designed to evaluate the safety and tolerability of the vaccine, administered by two     different routes (intramuscular and intravaginal) as primary endpoint. Immunogenicity will be     evaluated as secondary endpoint.   "
245807|NCT01067144|"     The goal of this study is to determine whether administering Gabapentin prior to surgery     affects duration of pain and opioid use post-surgery. The investigators aim to compare     gabapentin to placebo in a prospective, randomized clinical trial in which patients will be     followed post-surgery until pain resolves and opioid use ceases.   "
245810|NCT01067183|"     Given the nature of their work duties and work environment, physicians often experience     stress within the workplace and chronic stress negatively impacts physician wellness.     Physician wellness is now linked to quality of patient care. The stress response can be     broken down into four components: the stressor, the reaction, the physiological response and     the experience of the physiological response. Stress can also be absolute (e.g. threat to     life) and relative (e.g. I have 3 more consults to see). Stress management refers to a range     of processes that are intended to mitigate one or more aspects of the psychobiology of     stress. Biofeedback is a useful way of providing guidance and reinforcement for successful     management of the physiological response to stress. It is important to provide physicians     with effective tools for stress management. The objective of this study is to compare     measures of stress and well-being among physicians allocated to learn a relaxation breathing     technique and to use a biofeedback tool (referred to as a portable stress management device     or PSMD) for 28 days (intervention group) and those allocated to standard care for 28 days     (control group).   "
245811|NCT01067196|"     The purpose of this study is to collect information from medical records to see what effects     proton beam radiation has on cancer and analyze possible side effects.   "
245812|NCT01067209|"     The overall purpose of this study is to evaluate the effect of gastric bypass surgery-induced     weight loss on the heart's function and on fat deposits in the heart muscle.   "
245813|NCT01067222|"     The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by     individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)   "
245814|NCT01067235|"     The objective of this study is to evaluate and compare the efficacy and safety of escalating     doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy   "
245815|NCT01067248|"     The main objective is to study important factors in the patho-physiology of osteoporosis in     patients with COPD. Therefore, the investigators will study biological markers in plasma and     urine and correlate them to markers of bone turnover and clinical data.   "
245816|NCT01067261|"     After radical prostatectomy nerve damage in the pelvic floor usually occurs. This causes side     effects in the form of incontinence and erectile dysfunction.      It has previously been shown that one can stimulate the nerves of the pelvic floor by means     of transcutaneous mechanical nerve stimulation (TMNS) done through vibration. This study will     examine the effect of TMNS in the preservation and restoration of urinary continence and     erectile function and in the treatment of urinary incontinence and erectile dysfunction in     conjunction with radical prostatectomy.      The theory is that by means of TMNS one can stimulate the nerves of the pelvic floor and the     penis which may improve their function and there by prevent or minimize the occurrence of     incontinence and erectile dysfunction following pelvic surgery. Vibration may also help to     eliminate these symptoms once they have occurred. It is possible that TMNS will also directly     increase the blood flow in the cavernosal tissue thus aiding in the preservation of this     tissue. In case the improved nerve function is not great enough to secure satisfactory     erectile function in itself it may still improve the effect of PDE-5-inhibitors.      In pilot studies TMNS has already shown an effect in the treatment of urinary continence.      In this study the patients will be randomized to either TMNS treatment or no TMNS treatment.     In both groups the patients will participate in a pelvic floor muscle training program. In     the group receiving active treatment this will be supplemented by TMNS treatment. The two     groups will be evaluated and compared with regard to erectile function time to continence     after surgery.   "
245854|NCT01067768|"     The purpose of this study is to determine whether the daily nurse review of the indication of     the urinary catheter compared to the everyday care of the working staff is effective to     reduce the rate of catheter-associated urinary tract infection in adults hospitalized.   "
245855|NCT01067781|"     The purpose of this study is to evaluate and compare the safety and immune responses     following a two vaccination regimen by transcutaneous immunization with heat-labile     enterotoxin of E. coli (LT) patches or placebo   "
245817|NCT01067274|"     A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid     (ATRA) in Combination with Induction Chemotherapy, or Azacitidine and Idarubicin as salvage     therapy and Idarubicin with Cytarabine or Azacitidine as Maintenance Therapy in Older     Patients with Acute Myeloblastic Leukemia (AML).      To compare the outcome of elderly patients with newly-diagnosed AML treated with standard     induction chemotherapy and post-remission therapy, in only patients in CR, with either     azacitidine or cytarabine combined to idarubicin +/- ATRA and salvage therapy with     azacitidine combined to idarubicin +/- ATRA.   "
245818|NCT01067287|"     The purpose of this research study is to determine the safety of CT-011 alone, as well as the     combination of the Dendritic cell fusion vaccine and CT-011, after autologous stem cell     transplantation (ASCT). We are also trying to find out what effect the combination has on the     disease, including if it is more successful in preventing or delaying the disease from coming     back, compared to treatment with autologous transplantation alone. ASCT is a standard therapy     for multiple myeloma that is often successful in significantly decreasing the amount of     cancer in the body. CT-011 is an investigational monoclonal antibody. Monoclonal antibodies     are a type of drug given by infusion into a vein and are known to target specific cells (in     this case, cells in the immune system). The dendritic cell fusion vaccine is an     investigational agent that tries to help the immune system to recognize and fight against     cancer cells. Unlike a standard vaccine that is used to prevent infections, cancer vaccines     are being studied to see if they can fight cancers that are already in the body.   "
245832|NCT01067469|"     The goal of this clinical research study is to learn if the combination of bevacizumab and     lomustine can help to control glioblastoma. The safety of this combination will also be     studied.   "
245833|NCT01067482|"     The purpose of this study is to evaluate performances of each parameters of spectral domain     (Cirrus) optical coherence tomography for distinguishing between normal eyes, glaucoma     suspect and glaucomatous eyes   "
245834|NCT01067495|"     Despite the similarities between heart disease and stroke in terms of disease process and     elevated risk of recurrent events, exercise-based programs akin to cardiac rehabilitation are     not available for people with stroke.      The purpose of this study is to examine 1) the feasibility of adapting cardiac rehabilitation     for individuals with stroke, and 2) the effects of this program on aerobic capacity, walking,     risk factors, community integration and quality of life.      The investigators anticipate that cardiac rehabilitation may be appropriately adapted to     accommodate individuals with stroke who have a range of functional abilities, and that this     program is effective in improving aerobic capacity, walking ability and stroke risk factors.     The investigators also anticipate participants will demonstrate improved community     integration and quality of life following this program.   "
245819|NCT01067300|"     Unrelated cord blood transplantation (UCBT) has been used for several years when there is no     HLA identical sibling or unrelated donor.Since the recent publication of encouraging results     after transplantation of two UCB units, the number of these double-transplantations increases     in a very significant way.However, there is currently no prospective study comparing in a     reliable way the double-transplantation to single-transplantation results.The investigators     propose a prospective and randomized study comparing the results of single versus double unit     UCBT in children and young adults (< 35 yrs) with acute leukemia in remission. This is an     open, multicenter study carried out in the allogeneic transplant centers from the French     society for hematopoietic stem cell transplantation and cell therapy. The primary objective     is to compare the incidence of transplantation failure in the two treatment arms.     Transplantation failure, the primary endpoint of the study, is defined by the occurrence of     one of the following events : transplant-related death, second allogeneic transplantation or     autologous backup infusion for primary engraftment failure, autologous recovery. The     financial impact of these double-transplantations being to date unknown, the project also     includes a cost-effectiveness study, the effectiveness criterion being a decrease in     transplantation failure incidence. The secondary clinical endpoints are: overall survival and     disease-free survival, relapse incidence, transplant-related mortality, incidence of severe     infections and GvHD. The secondary biological endpoints are: hematological and immunological     recovery, post transplant chimerism.   "
245820|NCT01067313|"     This study aims to demonstrate equivalence in terms of molecule removal between continuous     hemodialysis using an enhanced middle molecule clearance membrane(Ultraflux EMiC2) and     continuous hemofiltration using a standard membrane (Ultraflux AV1000S) in ICU patients     requiring continuous renal replacement therapy.   "
245821|NCT01067326|"     We will study the hypothesis that long-term Tekturna treatment will improve endothelial     function and the production and function of endothelial progenitor cells (EPCs) in patients     with early atherosclerosis. Specifically, long-term Tekturna treatment will increase the     Reactive Hyperemia Peripheral Arterial Tonometry indexes and increase the numbers and the     function of circulating endothelial progenitor cells, compared to placebo, in association     with a reduction in inflammation and oxidative stress.   "
245822|NCT01067339|"     AIM III is a prospective, randomized, double-blinded, placebo controlled trial. The study is     directly connected to IRB 08-008161 as a specific aim of the National Institute of Health     (NIH) grant. Participants may either consent to and qualify for AIM I and AIM II (IRB     08-008161) or have a cardiac catheterization with acetylcholine testing in the Cardiac     Catheterization Laboratory at Mayo Clinic in Rochester, Minnesota to be considered for this     study.   "
245823|NCT01067352|"     This open, multicentric, randomized, controlled study is planned to evaluate the correlation     between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in     SGA children.   "
245824|NCT01067365|"     Subjects who completed ZA-003 were eligible to receive an additional year of treatment in     this extension study.   "
245879|NCT01073475|"     The primary purpose of this population-based study is to quantify and understand the trends     in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide     population-based data on stillbirths, neonatal and maternal mortality.   "
245911|NCT01074242|"     This survey is conducted for preparing application materials for re-examination under the     Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the     clinical usefulness of Rotateq through collecting the safety information according to the     Re-examination Regulation for New Drugs.   "
245825|NCT01067378|"     Crisis management is important for operating room practice and non-technical skills are     acknowledged as key to ensure patient safety in these situations. Unfortunately, it can be     difficult to find instructors with appropriate experience. A peer-led team debriefing is led     by the team it self rather than an external expert instructor but remains a reflective     process. Incorporating peer-led debriefing compared to expert-led debriefing may increase     access to an interprofessional crisis resource management course using simulation.      The goals of the study are to observe the effect of an interprofessional peer-led team     debriefing in the change in performance of non-technical skills of team performance and to     compare it with the gold standard of expert-led debriefing on the performance of     non-technical skills during a simulated operating room crisis.      The investigators hypothesize that interprofessional peer-led debriefing will improve the     performance of non-technical skills of the team during simulated intraoperative crisis     management and that this improvement will be equivalent to the gold standard expert-led     debriefing.   "
245826|NCT01067391|"     To address the effect of tadalafil (Cialis) on the cardiovascular system of men with complete     spinal cord injury at T-6 and above. The hypothesis is that tadalafil will cause significant     hypotension in people with tetraplegia.   "
245827|NCT01067404|"     Each winter, viruses belonging to two kinds of influenza A (A/H1N1 & A/H3N2) and two     kinds of influenza B (B/Yamagata & B/Victoria) can cause illness. The yearly influenza     vaccine is designed to protect against both kinds of influenza A but only one or the other     kind of influenza B. The vaccine is changed from year to year, meaning it may include one     kind of B virus one year and the other kind another year. But because influenza is so hard to     predict, sometimes the kind of B virus chosen for the vaccine may not match the kind that is     causing illness. The National Advisory Committee on Immunization recommends that all infants     and toddlers receive influenza vaccine to protect against their high rates of     hospitalization. Infants/toddlers receiving influenza vaccine for the first time must get two     doses (prime plus boost) to have a good antibody response. If they have ever before received     a single dose of influenza vaccine, then they are recommended to receive only one dose each     year afterwards. But we don't know how well previous doses of one kind of influenza B set the     stage for good antibody response to a single dose of the other kind of influenza B. This     study will try to answer that question in a group of infants/toddlers who last year received     two doses of one kind of B virus (Yamagata), as part of another study. This year, we will     give them a single dose of influenza vaccine that now contains the other kind of B virus     (Victoria) and see how much antibody they make to both kinds. About half these children     received a higher amount of influenza vaccine in the previous year's study, so we will also     compare their antibody levels on that basis. Since influenza B is an illness especially of     children, understanding how to best protect infants/toddlers against both kinds of influenza     B is important. This study will help us know if we need to design a new vaccine that not only     includes both kinds of influenza A, but also both kinds of influenza B.   "
245828|NCT01067417|"     The purpose of this pilot study is to find out if taking hydroxychloroquine will decrease     immune activation (stimulation of the body's defence system) in people with early HIV     infection. Hydroxychloroquine is a medicine that has been used successfully for many years to     treat autoimmune diseases (diseases in which the immune system causes damage to the body),     e.g. lupus and rheumatoid arthritis. It is generally safe in long-term use and easily     accessible.      The immune system is stimulated in response to infections including HIV, so treatments that     decrease immune activation may have long-term clinical benefits i.e. delay onset of     treatment.   "
245829|NCT01067430|"     The purpose of this study is to explore the effect of Etoricoxib compared to Diclofenac on     physical activity in RA subjects with early morning pain and stiffness.   "
245830|NCT01067443|"     This study is to assess if shorter combinations of SSG plus single dose AmBisome®,     Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating     visceral leishmaniasis in Eastern Africa.   "
245836|NCT01067521|"     The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg     administered three times a week compared to placebo in subjects with RRMS, as measured by the     number of confirmed relapses during the 12 month placebo controlled phase. The study has two     phases:        -  Placebo Controlled Phase: 12 months of 40 mg administered three times a week by          subcutaneous injection or matching placebo.        -  Open Label Extension: All subjects will continue treatment with GA 40 mg administered          three times a week, until this dose strength is commercially available for the treatment          of relapsing remitting multiple sclerosis (RRMS) patients or until the development of          this GA dose regimen is stopped by the Sponsor   "
245837|NCT01067534|"     Studies evaluating response to bronchodilation in flow-volume spirometry and/or by forced     oscillations technique (FOT), have been conduced in subjects with obstructive airways     diseases. Less is known about bronchodilation responses, assessed by both spirometry and FOT     in healthy young subjects.      The purpose of the present study is        1. to determine the range of the bronchodilation response in terms of changes in selected          spirometric parameters in healthy non-smoking young adults, for identifying normal          response after an inhaled bronchodilatory agent versus placebo, and its anthropometric          and spirometric determinants        2. to determine the range and characteristics of bronchodilation response using          pseudorandom FOT in healthy non-smoking young adults, for identifying normal response          after an inhaled bronchodilatory agent versus placebo, and its anthropometric and          oscillometric determinants.        3. to compare and correlate eventual changes in spirometric and oscillometric parameters.      The investigators hypothesize that exists a normal variation in spirometric and oscillometric     parameters after bronchodilation, and that these parameters are correlated.   "
245856|NCT01067794|"     This observational study was planned, with the primary objective to observe patient survival     following first-line treatment of patients of Stage IIIB/IV Non-small Cell Lung Cancer     (NSCLC) with different platinum-based doublets under routine disease management conditions.     Further secondary objectives of this study are to provide insights to what extent histologic     subtyping and the use of additional prognostic or predictive biomarkers are currently     considered for differential therapeutic decisions under routine conditions. All of these data     are critical to evaluate the factors for differential therapeutic decisions and their effect     on patient outcomes in a real life setting, and they can only be obtained through     observational research.   "
245857|NCT01067807|"     Healthy female subjects received a single dose of four different types of Proellex, the     original 25 mg dose and three new formulations   "
245858|NCT01067820|"     This study is designed to characterize the early effects of ApoA-I synthesis with RVX000222     on coronary atherosclerotic disease when administered to patients with coronary artery     disease and have a low HDL-C level, as assessed by Intravascular Ultrasound (IVUS) in     addition to standard background therapy.   "
245859|NCT01073202|"     This study is designed to investigate the possible beneficial effects of UDCA on liver graft     recovery early after adult liver transplantation.   "
245838|NCT01067547|"     Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or     intravenous route in Inflammatory Bowel Disease patients.      Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD)     and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment     options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron     replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor     quality of life, poor concentration span and low energy level. Blood transfusion may improve     symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born     infection transmission. Moreover, packed cells are scarce resource therefore its use needs to     be carefully prioritized. Oral iron supplement has been widely used and it can be purchased     over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly     tolerated with side effects include altered bowel habit, nausea and darken stools, making it     difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to     replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has     been supported by its post marketing surveillance. Limitations with intravenous iron     replacement include the need for medical supervision in the setting of limited healthcare     resources; the need for patients to take multiple days off work and the cost of Venofer®.     Currently it is uncertain which method of iron replacement is better. The purpose of this     study is to compare the efficacy and the cost of oral and intravenous iron replacement in the     setting of iron deficiency anaemia.   "
245839|NCT01067560|"     This study will determine the level of glucose (sugar) in the CSF (fluid that surrounds the     spinal cord) in 30 subjects having spinal anesthesia for cesarean section using a bedside     glucose meter. Spinal anesthesia is done by injecting drugs through a needle into the CSF.     Subjects will have 1/10 tsp of CSF removed at the time of spinal anesthesia to measure the     level of glucose. Glucose meters measure glucose, usually in the blood, and they can be used     in the operating room. This study will see whether a glucose meter will easily measure the     level of glucose in CSF.   "
245840|NCT01067573|"     To determine a correlation between serum leptin levels, nitric oxide preceding a relapse and     change in leptin and nitric oxide levels during exacerbation in relapsing remitting multiple     sclerosis patients.   "
245841|NCT01067586|"     The extent of toxicity varies considerably across different brands of smokeless tobacco (ST)     products and data suggest that greater toxicity may result in greater health risks. However,     little is known about the actual extent of exposure to toxicants from current smokeless     tobacco products and factors that might moderate the extent of this exposure. The goals of     this project are to address the following questions:        1. What are the characteristics of the range of smokeless tobacco products in current use          and how do these products impact user behavior;        2. What are novel and the best measures of smokeless tobacco use, behavior and exposure;          and        3. What are some of the determinants of smokeless tobacco use.   "
245842|NCT01067599|"     The research project will determine the level of nicotine in ST products that will lead to     the greatest reduction in toxicant exposure   "
245843|NCT01067625|"     This study is a prospective single-arm, multicenter study to evaluate the safety and     effectiveness of the TOGA® Procedure for the treatment of morbid obesity.   "
245844|NCT01067638|"     The Effect of Tranexamic Acid on Postoperative Blood loss and Coagulation in Patients with     Preoperative Anemia Undergoing Off-Pump Coronary Artery Bypass Graft; double blind randomized     control study.   "
245845|NCT01067651|"     The purpose of this study was to determine the influence of cast material on correction of     congenital idiopathic clubfeet using the Ponseti method.   "
245846|NCT01067664|"     This observational study attempts to investigate the potential role of serum progesterone     levels on the day of hCG administration (thus, the end of the follicular phase) on the     probability of pregnancy, in patients undergoing IVF with the use of GnRH antagonists and     recombinant gonadotrophins.      There has been evidence, that increased serum levels of progesterone are associated with a     decreased probability of pregnancy after IVF.      This study will attempt to explore the role of progesterone on the outcome of IVF, by closely     monitoring its levels during the late follicular phase.   "
245937|NCT01074580|"     The purpose of this study is investigate if high frequency sonography and contrast enhanced     sonography can be used to predict remission in patients with deterioration of Crohn's disease     treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.   "
250402|NCT01134224|"     This trial is conducted in Europe. The aim of this trial is to evaluate the blood     glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects     with type 2 diabetes.   "
245847|NCT01067677|"     To compare ondansetron, metoclopramide, diphenhydramine, and placebo in order to determine     which anti-emetic is most efficacious as a rescue therapy for pediatric patients ages 3-18     who have post-operative vomiting after a standardized prophylactic regimen of ondansetron and     dexamethasone. We hypothesize that anti-emetics with a different mechanism of action than the     prophylactic regimen will be the most effective rescue therapy in children having surgery     in an ambulatory surgery center.        1. Problem: Despite commonly-used anti-emetics for prophylaxis, some children still go on          to develop post-operative vomiting (POV).           Goal: To determine which anti-emetic--ondansetron, metoclopramide, diphenhydramine, or          placebo--is most efficacious for pediatric patients in this situation.        2. Hypothesis: Anti-emetic medications that have a different mechanism of action than the          prophylactic regimen will be the most efficacious rescue therapy.        3. Hypothesis: Metoclopramide at the dose of 0.5 mg/kg (max dose 20 mg) will be more          effective than ondansetron, diphenhydramine, or placebo as rescue therapy.   "
245848|NCT01067690|"     The purpose of this study is to determine the clinical response to daily Indinavir oral     administration in association with a conventional chemotherapy based on cycles of systemic     Vinblastine +/- Bleomycin in patients affected by advanced classical (non HIV-associated)     Kaposi's sarcoma   "
245849|NCT01067703|"     The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on     perioperative ischaemic injury in patients undergoing cardiac surgery compared to control     intervention.   "
245850|NCT01067716|"     The results of this trial will demonstrate that AVSS software performs as intended and is     acceptable in a clinical setting.   "
245860|NCT01073215|"     The Primary Care Research Network for the Treatment of Adolescent Obesity will establish     infrastructure within the primary care setting to support programmatic research on weight     loss for underserved adolescents, primarily urban African Americans, rural Caucasians, and     Latinos. Using primary care settings, to which many youths already have entry, may increase     access for underserved adolescents to participate in obesity treatment and research. The     primary project will be a 12 month randomized controlled study comparing the relative     effectiveness of two interventions for weight reduction: Group Condition (a family based     lifestyle modification program delivered by health care providers in 23 sessions);     Self-Guided Condition (a family based lifestyle modification program that combines a     self-guided, home-based approach with 6 sessions delivered by health care providers).   "
245861|NCT01073228|"     This study is being conducted to determine the safety and effect on cognitive function of the     investigational medication, EVP-6124, in individuals with mild to moderate probable     Alzheimer's disease.   "
245862|NCT01073241|"     In this study, the investigators designed a randomized and double-blind prospective trial to     evaluate the efficiency and safety of the investigators new approach—transurethral ventral     wall of urethra-preserving enucleation of prostate in comparison with TURP for the     hyperplasia weighing more than 45 g.   "
245863|NCT01073267|"     The goal of this clinical research study is to learn if a lower than standard dose of total     skin electron beam radiation therapy to the skin can help to control mycosis fungoides. The     safety of this dose level will also be studied.   "
245864|NCT01073280|"     The investigators will take cerebral and subarachnoid biopsy by flexible endoscopy in     patients without neurological findings. The investigators will use retrospective and     prospective patients.   "
245865|NCT01073293|"     This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is     well tolerated and causes a non-inferior immune response when compared to administration of     REPEVAX™ one month following the first dose of V503.   "
245868|NCT01073332|"     Human exercise capacity decreases with aging. One explanation may be that blood vessels     stiffen with age and release less of a compound called nitric oxide (NO). This compound     normally relaxes blood vessels and increases blood flow to muscles, but damaging compounds     called free radicals can interfere with this process. Antioxidants may help prevent free     radicals from inactivating nitric oxide. The purpose of this study was to investigate the     effects of an antioxidant supplement that supports NO production on exercise performance in     elderly male cyclists.   "
245869|NCT01073345|"     The aim of this study is to investigate the pathophysiological mechanisms underlying the     formation of posthepatectomy ascites with a focus on the significance of changes in portal     venous hemodynamics after hepatic resection. By evaluation of other factors that may be     involved in the formation of ascites this study may help to show to what extent the increase     of portal venous pressure contributes to ascites formation. Detailed knowledge about     pathogenetic factors concerning the formation of postoperative ascites might help preventing     protracted hospital stay and further inconveniences to the patient.   "
245870|NCT01073358|"     It is uncertain, whether hilar lymphadenectomy should be performed routinely in patients     undergoing resection of colorectal liver metastases.      For this reason it is the aim of the present prospective randomized trial to evaluate, if     routine lymphadenectomy reduces recurrent disease in patients undergoing resection of     colorectal liver metastases.   "
245871|NCT01073371|"     This blinded randomized, crossover, three period study aim to evaluate the anesthetic     efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3%     prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the     maxillary right canine, in 32 volunteers.   "
245872|NCT01073384|"     The purpose of this study is to evaluate the safety and preliminary efficacy of four doses of     SGX201 in subjects with rectal cancer treated with concurrent radiation and chemotherapy.   "
245873|NCT01073397|"     The purpose of this research study is to compare yoga and health and wellness classes for     helping perimenopausal or newly postmenopausal women who are experiencing hot flashes. The     investigators want to learn about the effects of yoga and health and wellness classes on     symptoms and other quality of life issues. The results of this study may provide important     knowledge to women and clinicians who counsel women with menopausal hot flashes.   "
245874|NCT01073410|"     The purpose of this study is to find out the roles of two specific gene families (the     chitinase gene family and the TGFB family). We hypothesize that chitinases and TGFb pathway     genes will be differentially expressed in the airways of non-asthmatic subjects and subjects     with asthma. We further hypothesize that genetic variants in CHIT1, AMCase, and TGFb pathway     genes that show associations with asthma and related phenotypes will change the expression     and/or function of the protein of these genes in the airway in several ways, including the     transcript numbers for full length genes and splice variants and, for the chitinase genes,     the levels of chitinase activity in airway secretions.   "
245875|NCT01073423|"     The purpose of this study is to see if yoga or music therapy can improve the sleep of adults     with HIV.   "
245876|NCT01073436|"     To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML)     previously treated with interferon-alpha (IFN) and presently on a tyrosine kinase inhibitor     (TKI) (imatinib mesylate, dasatinib, or nilotinib) with achievement of a complete cytogenetic     and at least a major molecular remission, are able to discontinue therapy and maintain a     durable remission. Relapse-free survival (RFS) rate at 1 year after discontinuation of TKI     will be the measurement of this objective.   "
245877|NCT01073449|"     This study will enroll all patients who will attend an in-hospital follow-up of cardiac     device since February 22nd 2010 to June 21st 2010.      Primary objective of the study is to observe how many of patients seen during these period     (approximately 5000) will receive a change in cardiac device programming or in drug therapy     or a scheduled or urgent hospital admission.      These data should help to clarify how useful and safe is a remote monitoring strategy for     this kind of patients.   "
245878|NCT01073462|"     The purpose of this study was to ascertain the percentage of cardiac patients with chronic     kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid     hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI)     treatment guidelines (150 - 300 pg/mL) after 2 years.   "
245880|NCT01073488|"     The objective of this cluster randomized controlled trial is to reduce maternal and neonatal     mortality by increasing access to and improving the quality of obstetric and neonatal care     for pregnant women in study clusters. It is hypothesized that a 25% reduction in >28 week or     >1000 gram stillbirth and 7-day neonatal mortality will be achieved in the intervention     clusters by a multifaceted Emergency Obstetric Neonatal Care (EmONC) package that will be     introduced by an EmONC team.   "
245881|NCT01073501|"     Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced or     end-stage renal disease. Its intensity ranges from sporadic discomfort to complete     restlessness during both the day- and night-time and its distribution varies significantly     over time. Many attempts have been made to relieve this bothersome symptom in affected     patients, however with generally limited success. Incidence of UP varies widely between     studies and seems to decline over the last 30 years (from 85% in the 1970s and 50-60% in the     1980s to a 22% in the 2000s) (Gunal AI).      We use Pregabalin for the relief of diabetic neuropathic pain in patients on haemodialysis in     our centre. In addition to neuropathic pain, several of our patients have complained of     pruritus and after Pregabalin treatment, their pruritus has promptly and completely resolved.     Accordingly, we intend to conduct a double-blind, placebo-controlled, crossover trial to     assess the effectiveness of Pregabalin in chronic UP.   "
245938|NCT01074593|"     The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic     effect of two commercial preparations of interferon beta-1a (IFN Test: Lab Bergamo and IFN     Comparator: Rebif ® - Merck Serono Lab) after single administration (12.000UI) in healthy     subjects by modifying the parameters Cmax, Tmax and AUC (pharmacokinetics) and the levels of     2'5' oligoadenylate synthase and beta-2-microglobulin (pharmacodynamics).   "
245882|NCT01073514|"     To investigate bile culture and susceptibility test in patients with malignant biliary     obstruction (MBO) or relation between bile, portal vein or vein culture and biliary     infection. Also to get the information of bile metabonomics to find potential tumor marker     .Culture of the organism is recognized as the gold standard for diagnosis of infection. Our     research may be one of the first research on culture and susceptibility test in patients with     MBO. The results of the trial research will be benefit to experiential therapy of MBO with     biliary infection and diagnosis of MBO.   "
245883|NCT01073527|"     To investigate the efficacy of adding Inhaled Hypertonic Saline treatment (HS) for 1-6 year     old children with asthmatic attack presenting to Emergency Department (ED).      Background: In 1-6 year old children, the most common causes of acute exacerbations of asthma     requiring urgent medical care are viral respiratory infections. Most of these children are     not atopic and often do not respond very well to bronchodilators and steroids. Thus novel     treatments are needed.      HS is considered an effective and safe treatment for infants with acute viral bronchiolitis     (Cochrane 2008). HS acts in the airways in several mechanisms: HS re-hydrates secretions and     improving mucus rheology, reduce edema of the airway wall by absorbing water from the mucosa     and submucosa, causes sputum induction and cough, which can help to clear the sputum out of     the bronchi, stimulates cilial beat via the release of prostaglandin E2, breaks the ionic     bonds within the mucus gel, thereby lowering the viscosity and elasticity of the mucus     secretion.      It is estimated that all the above HS responding elements may play a role in this viral     induce wheezing. The above mentioned theoretical benefits provide the rationale for the     possible treatment of viral induced acute wheezing (asthma) attack with nebulized HS in     young pre-school children presenting to the Pediatric Emergency Unit with acute (mostly viral     induced) wheezing.      Therefore, the purpose of the present study is to 1. Investigate the addition of frequently     nebulized 5% HS/albuterol combination to standard therapy of acute asthmatic episodes     presenting to the emergency department (ED) in preschool children in a prospective,     randomized, double-blind, controlled fashion.   "
245884|NCT01073540|"     A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over     design was used with a washout of 7 days between the two study periods. Treatment groups     balanced with the same number of healthy volunteers who were randomly (in two strata: male     and female) assigned to the study drug administration sequences.   "
245885|NCT01073904|"     A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover,     randomized, prospective design was chosen with a washout of 14 days between the two study     periods. Treatment groups are balanced with the same number of male healthy volunteers who     were randomly assigned to the study drug administration sequences.   "
245886|NCT01073917|"     Atelectasis and redistribution of ventilation towards non-dependent lung zones are a common     side effects of general anesthesia. Spontaneous breathing activity (SBA) during mechanical     ventilation may avoid or reduce atelectasis, improving arterial oxygenation; however, it is     unclear whether these effects play a significant role during general anesthesia in patients     with healthy lungs. Earlier studies on ventilation during general anesthesia had to rely on     computed tomography (CT) findings. Recent advances in lung imaging technology allow to assess     the regional aeration of the lungs continuously and non-invasive by electrical impedance     technology (EIT). In this work, we will use the EIT to assess ventilation changes from the     time before induction of anesthesia until discharge from the post-anesthesia care unit. Our     main focus is the difference caused by pure positive pressure ventilation (PCV) and assisted     spontaneous breathing (pressure support ventilation, PSV). Our findings would improve our     understanding of the physiology of the lungs during general anesthesia and would help to     improve the standards of respiratory care during anesthesia   "
245887|NCT01073930|"     Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep:     2-sachets for oral solution in two divided doses given a night before (first dose - sachet)     and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral     solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its     effectiveness, tolerability and safety.   "
245888|NCT01073943|"     Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep:     2-sachets for oral solution in two divided doses given in the afternoon (first dose - sachet)     and 6 hours later in the evening (second dose - sachet), given the day before the procedure     or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the     procedure to evaluate its effectiveness, tolerability and safety.   "
245890|NCT01073969|"     The primary objective of this trial is to determine whether two doses of an extract from bran     demonstrate a prebiotic effect on colonic bacteria (by modulating selected fecal microbial     populations, particularly bifidobacteria). The secondary objective is to measure the     potential beneficial effects of consuming an extract from bran on the following physiological     parameters: laxation, fecal pH, fecal moisture and stool consistency, blood glucose and     insulin concentrations, plasma lipid profiles and serum free fatty acids, colonic bacterial     short chain fatty acid production, ammonia metabolism and protein degradation, and biomarkers     of oxidative stress and inflammation.   "
245891|NCT01073982|"     The purpose of this study is to assess the effects of tart cherry juice to reduce pain and     inflammation among individuals with arthritis.   "
245906|NCT01074177|"     In this research study we are looking to see how effective BIBW 2992 is at suppressing the     development of the T790M mutation in non-small cell lung cancer (NSCLC) patients. Epidermal     growth factor receptors (EGFR) are proteins found on the surface of some cancer cells that     promote a growth signal. Some cancer drugs for NSCLC work to block this signal from reaching     its target on the cancer cells which in turn may slow or stop the cancer from growing.     However, many times patients with EGFR mutations will stop responding to these cancer drugs     and develop drug-resistance because they have developed a specific EGFR mutation called     T790M. BIBW 2992 my prevent the T790M mutation from becoming active and therefore slow     disease progression.   "
245939|NCT01074606|"     The objective of this study is to evaluate the postoperative visual function of Taiwanese     patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.   "
245892|NCT01073995|"     The median Orthopaedic surgery wait time in Canada is 36.7 weeks (Esmail 2008), thus there is     a need to find alternative treatments for pathologies such as lumbar disc herniations (LDH).     The literature has demonstrated that selective nerve root injections (SNRI) are able to     alleviate sciatic symptoms caused by LDH (Riew 2006) and may be beneficial as an alternative     to surgery. It is necessary to determine whether SNRIs provide significant symptom resolution     alleviating the need for surgery, or to determine if their success is transient and delays     the time to surgery. The purpose of the proposed study is to evaluate the success of SNRI in     patients suffering with LDH and to determine which factors influence outcome. Over the span     of 2 years, data from 100 patients will be collected. These patients will be surgical     candidates and have exhausted all non-operative measures prior to receiving a SNRI. Upon     first assessment, each eligible patient will be randomly assigned to the treatment (steroid)     or control (saline) group. The patient and all treating physicians will be blinded to the     treatment given. Each patient will be followed over their course of treatment and information     pertaining to their pain and symptoms will be recorded using standard questionnaires. Patient     demographics, diagnosis, Worker's Compensation status, spinal levels treatment/outcome, and     time from referral to treatment will also be evaluated. The primary outcome measure will be     defined as the avoidance of surgery.   "
245893|NCT01074008|"     This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of     multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072     in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.   "
245894|NCT01074021|"     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in     the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical     trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has     been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and     nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult     with head and neck cancer. The study assessed the clinical efficacy, and safety of the     combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in     patients with advanced nasopharyngeal cancer.   "
245895|NCT01074034|"     Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.   "
245896|NCT01074047|"     The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional     care regimens on overall survival in elderly AML patients.   "
245897|NCT01074060|"     RATIONALE: There are different methods of stem cell mobilization, such as using     colony-stimulating factors alone or following chemotherapy priming. More recently, the     combination of plerixafor and colony-stimulating factors has been shown to enhance stem cell     mobilization. This study will assess whether the combination of plerixafor and Granulocyte     Colony-Stimulating Factor (G-CSF) is effective following chemotherapy mobilization with     cyclophosphamide.      PURPOSE: To assess the safety, tolerability, and best dose of intravenous plerixafor     following cyclophosphamide priming.   "
245898|NCT01074073|"     The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and     Lurasidone HCl.   "
245899|NCT01074086|"     A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML     treatment of patients older less than 65 years in relapse   "
245900|NCT01074099|"     Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2     centrifuge and have the concentrated nucleated cells injected into areas of ischemic     myocardium   "
245901|NCT01074112|"     The study is based on the premise that ultrasound is not commonly used in an ambulance. There     are some departments that do deploy it into the field, but of those departments there is     almost no data collected about its use. Currently Paramedics are not recognized by insurance     companies as health care providers capable of performing ultrasound. If there were more data     on the subject that may eventually change. We are hoping to prove that not only is ultrasound     useful in an ambulance, but that paramedics are good at interpreting the results. We will     save images, the paramedic's diagnosis and some basic information about the call. We will not     save any protected health information (PHI) or any information linking the subject to the     study. The data collected will be sent to a non-biased ultrasound reviewer to grade the     images for the accuracy of diagnosis and the quality of the view obtained. This data will be     used to formulate a report and statistics on paramedic's ability to perform ultrasound in the     field.   "
245912|NCT01074255|"     This survey is conducted for preparing application materials for re-examination under the     Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the     clinical usefulness of EMEMD (aprepitant) through collecting the safety information according     to the Re-examination Regulation for New Drugs.   "
245902|NCT01074125|"     This is a research study for people with high blood phosphorus levels who are on dialysis.     This medical condition can cause weakening of the bones and damage other organs. This can     lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat,     and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid     of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often     patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood     phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric     citrate) is safe and effective as a phosphate binder.   "
245903|NCT01074138|"     The standard of care for patients with bone-metastatic, castrate-resistant prostate cancer is     chemotherapy. If a patient elects not to choose chemotherapy, 70% will progress within 6     months. KX2-391 given orally twice a day for 6 months will be evaluated for its ability to     delay/prevent disease progression in patients who have not had prior chemotherapy.   "
245904|NCT01074151|"     The Cymbalta Pregnancy Registry is a U.S. based Registry designed to monitor women who are     exposed to Cymbalta (duloxetine) during pregnancy. This is an observational,     exposure-registration and follow-up registry.   "
245905|NCT01074164|"     The purpose of this study is to see if acupressure will be effective at reducing itch in     people with atopic dermatitis (AD).   "
245917|NCT01074320|"     Current guidelines recommend endocrine treatment with aromatase inhibitors (AIs) in     post-menopausal women with hormone receptor-positive breast cancer. Musculoskeletal symptoms     are commonly reported with AI treatment,however, we do not have consistent methods to measure     these symptoms prospectively. This gap in our knowledge inhibits the ability to test and     develop treatments for AI-associated musculoskeletal symptoms. This pilot study will evaluate     functional tests and standardized instruments for their ability to prospectively assess     musculoskeletal symptoms in women being treated with AIs for breast cancer.   "
245907|NCT01074190|"     A previous randomized trial showed a possible negative association with labor neuraxial     analgesia with high compared to low doses of fentanyl, and breastfeeding at 6 weeks     postpartum. The significance of this study would be to validate or refute these findings. In     addition, we hope to better evaluate the impact of cumulative dose of fentanyl on     breastfeeding success in the initial postpartum period as well as at 6 weeks and 6 months     post delivery. In order to better assess the quality of breastfeeding, we will utilize a     validated breastfeeding assessment tool, LATCH (Latch, Audible swallowing, Type of Nipple,     Comfort, and Help). This validated tool can assess maternal and infant variables, define     areas of needed intervention, and determine priorities in providing patient teaching. The     LATCH assessment has been shown to be a predictor of breastfeeding duration. We also plan to     vary the dosage of fentanyl analgesia to determine the relationship between doses below 150     micrograms and changes in breastfeeding assessments. If a clear association between decreased     breastfeeding and total fentanyl is identified, then regimens to reduce cumulative doses of     fentanyl can be developed to improve the likelihood of breastfeeding success in mothers that     desire to breastfeed.      Prior observational studies have inferred epidurals negatively affect breastfeeding by     decreasing maternal plasma oxytocin release which may adversely affect infant neurobehavioral     development. In a study by Beilin et al., it was reported that mothers receiving a high     cumulative dose (> 150 microgram) epidural fentanyl were more likely to have stopped nursing     6 weeks postpartum compared with groups receiving no fentanyl or those receiving < 150     microgram. The study however, was underpowered to detect differences in breastfeeding prior     to hospital discharge. In addition, the breastfeeding assessment tool utilized resulted in     binary assessments, and therefore, a global rating of the quality of breastfeeding was not     available.   "
245908|NCT01074203|"     Recurrence of Hepatitis C virus infection (HCV) is universal after orthotopic liver     transplantation (LTx) and is associated with allograft failure, death and need for     re-transplantation. Currently, there are no effective therapies to prevent HCV recurrence.     Nitazoxanide (NTZ), an oral thiazolide anti-infectious agent, was safe, well tolerated and     effective in achieving sustained viral response in patients with chronic HCV genotype 4. Its     role in the prevention of HCV recurrence after liver transplantation has not been studied.     The investigators propose to conduct an open label pilot study examining the role of NTZ in     the prevention of HCV re-infection in eight patients undergoing LTx. First time transplant     recipients for chronic HCV without history of renal failure or HIV/HBV co-infection, will     receive NTZ immediately prior to LTx and for 3 days thereafter. The primary endpoint is the     number of patients who remain HCV-RNA-negative at day 7 after LTx. If at least one patient     remains negative, the study will be determined to be positive. Additionally, the     investigators will examine the viral kinetics of HCV, tolerability and safety of NTZ.   "
245909|NCT01074216|"     The purpose of this study is to find out what effects, good and/or bad, vitamin D blood     levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to     increase low vitamin D levels into normal range using vitamin D supplements taken by mouth.     Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low     vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if     increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely     repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given     would be considered standard of care.   "
245910|NCT01074229|"     The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior     -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and     the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of     local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse     abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal     wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was     first described by McDonnell et al. as a landmark technique to provide analgesia for lower     abdominal surgery.      Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which     they named posterior TAP block. The ultrasound allows identification of the external oblique     abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional     anesthetic techniques suggest improved block quality and safety, which is primarily due to     direct visualization of the relevant anatomy, the tip of the needle, and the spread of the     local anesthetics.      Clinical trials of the single shot posterior TAP block have shown a significant reduction in     morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly     et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic     cholecystectomy reduced perioperative opioid consumption by more than 50%.      This is the first study to evaluate the effect of TAP block in the quality of recovery in     patients undergoing laparoscopic hysterectomy and may help the pathway to make this an     outpatient procedure.   "
245993|NCT01075308|"     RATIONALE: SB939 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase II trial is studying how well SB939 works in treating patients with     recurrent or metastatic prostate cancer.   "
245913|NCT01074268|"     This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to     compare the efficacy, safety and tolerability of NN1250 (insulin degludec ([Deg]) with     insulin detemir (IDet), both combined with insulin aspart.      The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension     period is registered as NN1250-3725.   "
245914|NCT01074281|"     This non interventional, multicentric, uncontrolled, prospective, observational study was     planned to observe the course of disease in subjects with ISH, who were treated with Eneas.   "
245915|NCT01074294|"     This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in     adults with Attention Deficit Hyperactivity Disorder (ADHD) when taken with an approved     stimulant medication to explore a possible impact on sleep, quality of life and cognitive     function.   "
245916|NCT01074307|"     This is a prospective, open-labeled, multi-centric trial to evaluate the effect of bisoprolol     (between low dose and high dose) on surrogate markers of heart failure in Korea.   "
245918|NCT01074333|"     This is an observational, non-interventional, uncontrolled, multicentric safety study in     subjects with epidermal growth factor receptor (EGFR)-expressing, V-Ki-ras2 Kirsten rat     sarcoma viral oncogene homolog (KRAS) wild-type mCRC. The study aims to collect safety data     related to Erbitux treatment from a total of at least 400 mCRC subjects from about 35     institutions from the start of treatment with Erbitux until progressive disease,     Erbitux-related intolerable toxicities, death, or withdrawal of Erbitux treatment (whichever     occurs first).   "
245920|NCT01074359|"     This is a phase 2a, double-blind, placebo-controlled, single-center study. Twenty-one     patients who qualify for the study will be randomly assigned to either active drug or     placebo. The study will take place at Newcastle University. Patients will have a 66% chance     of getting active drug. Patients will be required to take study treatment orally twice a day     for 28 days. A baseline visit will occur within 21 days of screening visit. All patients will     be followed for 1 week after completion of study or early withdrawal from the study.   "
245921|NCT01074372|"     This study will test the safety and tolerability (how the body reacts to the drug) of REGN727     compared with placebo (an inactive substance that contains no medicine) in healthy subjects.     The study drug and placebo will be administered by an injection under the skin at one clinic     visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be     monitored by the study staff for side effects and the body's response to the study drug.     Vital signs (blood pressure, temperature, breathing and heart rate) will be checked, and     blood and urine samples will be collected at some or all visits.   "
245922|NCT01074385|"     The purpose of this study is to try and improve the way that patients with colon cancer     understand and cope with their illness and give them tools for talking with their loved ones     and family about their illness.   "
245923|NCT01074398|"     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how well patients will respond     to treatment.      PURPOSE: This research study is looking at biomarkers in predicting response in patients with     advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.   "
245924|NCT01074411|"     This phase I trial studies the side effects and best dose of intraperitoneal bortezomib when     given together with intraperitoneal carboplatin in treating patients with ovarian epithelial     cancer, fallopian tube cancer, or primary peritoneal cancer that is persistent or has come     back. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Bortezomib may help carboplatin work better by making     tumor cells more sensitive to the drug. Infusing bortezomib and carboplatin directly into the     abdomen (intraperitoneal) may kill more tumor cells.   "
245925|NCT01074424|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer. It may also help doctors     predict how well patients will respond to treatment.      PURPOSE: This research study is looking at biomarkers in blood samples from patients with     invasive cervical cancer.   "
245926|NCT01074437|"     This is a prospective randomized, double-blind study to compare the clinical efficacy of     infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy     with corticosteroids and placebo. We hypothesize that a two-month treatment period with     propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and     vascularity when compared to corticosteroids used without propranolol for the same time     period.   "
245927|NCT01074450|"     The object of this study was to compare the relative bioavailability (rate and extent of     absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with     that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc.     following a single oral dose in healthy adults under fasting conditions.   "
245928|NCT01074463|"     The object of this study was to compare the relative bioavailability (rate and extent of     absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with     that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc.     following a single oral dose in healthy adults under non-fasting conditions.   "
245929|NCT01074476|"     Osteoarthritis (OA) is the most common joint disease associated with aging. Although many     patients take glucosamine supplements as a non-traditional treatment for osteoarthritis, the     effectiveness of these supplements is questionable. This study will evaluate glucosamine     therapy by directly analyzing two functions of joint fluid that are impaired by     osteoarthritis - namely, the abilities to lubricate the joint and absorb shocks during     activity. Joint fluid samples will be collected from subjects with knee osteoarthritis and     analyzed on a device that simulates typical joint movements. After 3 months of glucosamine     supplementation, samples will be collected again to detect potential improvements in joint     fluid function.   "
245930|NCT01074489|"     The purpose of this research study is to compare 3 methods of measuring blood glucose (blood     sugar) levels to see if the finger-stick method or the continuous glucose monitoring system     is better than or as good as the 3 hour glucose tolerance test (GTT) for the diagnosis of     gestational diabetes.   "
245931|NCT01074502|"     Acne is a chronic inflammatory disease of the pilosebaceous unit that affects 80-90% of the     population, especially teenagers, although adult acne is a significant problem for 3-6 % of     adult men and 5-12% of adult women. Although acne is not a life-threatening disease, it     produces significant psychological disturbances and permanent skin scars.      A novel anti-inflammatory, not antibiotic drug may be an excellent alternative for the     treatment of moderate to severe acne. Apremilast has been shown to inhibit the production of     tumor necrosis factor (TNF)-alpha, IL-8 and neutrophil infiltration, all of which are     elevated in inflammatory acne.      Our intention is to study Apremilast in the treatment of moderate to severe acne.   "
245932|NCT01074515|"     The goal of the study is to look at how genes and certain chemicals in the body are related     to depression and chronic obstructive pulmonary disease.   "
245933|NCT01074528|"     The main purpose of this study is to evaluate the effects of the Mindfulness Based Stress     Reduction (MBSR) training program that is offered in the investigator hospital, more     specifically on quality of life, coping strategies and partner relationship by using     questionnaires. To asses the possible impact of this treatment on the latter domain, partners     of the patients with a cancer diagnosis are invited to join the training program.   "
245934|NCT01074541|"     The purpose of the study is to determine the importance of the UV intensity and the UVB dose     on the Vitamin D response after UVB.   "
245940|NCT01074619|"     The purpose of this study is to determine if memantine is effective in the treatment on     cognitive disorders of Relapsing - Remitting multiple sclerosis. m   "
245942|NCT01074645|"     Background: Reactivation of hepatitis B is a well-characterized syndrome marked by the abrupt     reappearance or rise of hepatitis B virus (HBV) DNA in the serum of a patient with previously     inactive or resolved HBV infection. Reactivation can be spontaneous, but is most commonly     triggered by cancer chemotherapy, immune suppression, or alteration in immune function.     Spontaneous acute exacerbation of chronic hepatitis B infection is seen with a cumulative     probability of 15±37% after 4 years of follow-up.2 Significant number of patients of     spontaneous acute exacerbation of chronic hepatitis B may present with very high ALT levels,     jaundice and liver failure.3 This condition should be defined as acute-on-chronic liver     failure (ACLF) according to a recent Asia-Pacific consensus recommendation.      The short term prognosis of patients of spontaneous acute exacerbation of chronic hepatitis B     leading to ACLF like presentation is extremely poor, with a mortality of 30-70% in different     series.8,9,10 Liver transplantation has been the only definitive therapy available to salvage     this group of patients. However ,this is not readily available and affordable. Another     therapeutic option is antiviral therapy but has limited data. The efficacy of lamivudine was     evaluated and compared by historical control but was not found to be beneficial.8,9,10     However ,a study from Taiwan showed a survival benefit in a subgroup of patients who were on     lamivudine and had baseline bilirubin below 342 mmol/L (20 mg/dL).11 Tenofovir disoproxil     fumarate (TDF) is a potent, rapidly acting, oral acyclic nucleotide analogue, reverse     transcriptase inhibitor that has been shown to be highly effective in suppressing hepatitis B     virus replication.12 Tenofovir has also shown excellent activity against HBV in both LAM-     naïve and LAM-resistant patients.13,14. Its efficacy has not been evaluated in patients of     reactivation of hepatitis B who present as ACLF Hypothesis: The investigators hypothesis that     Tenofovir reduces the morbidity and mortality in patients with Spontaneous reactivation of     hepatitis B by reducing HBV DNA.   "
245943|NCT01074658|"     The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic     CoreValve System in a Real-World patient population.   "
245944|NCT01074671|"     The primary goal of the study is to document the number of patients that are successfully     implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.   "
245945|NCT01074684|"     The purpose of this study is to describe the correlation between the cytohistology exam of     patients undergoing thyroid surgery, and the predictive values of: suspicious clinical     findings, preoperative thyroid imaging, and the incidence of thyroid cancer in cytologically     negative nodes.   "
245946|NCT01074697|"     GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group     study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist     (fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting)     control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer     diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy.      The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug     regimen (standard treatment) in preventing nausea and vomiting in patients receiving     radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of     patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and     it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase     the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.   "
245947|NCT01074710|"     The purpose of this study is to evaluate the safety and establish the pharmacokinetic (PK)     profile of C13-URA in healthy volunteers   "
245948|NCT01074723|"     We, the investigators, aim to study, in vitro and in vivo, the bioavailability of added     b-cryptoxanthin and phytosterols and evaluate in vivo its effect on biochemical markers of     bone remodelling and cardiovascular risk. Specifically, we will 1) assess the stability in     the food and the bioavailability of b-cryptoxanthin in the presence of phytosterols     (absorption modifiers) by using a complementary approach; in vitro and in vivo studies; and     2) we will study in post-menopausal women (target group) the biological effect (bioefficacy)     associated with the regular consumption of modified milk-based fruit beverages (containing     b-cryptoxanthin and phytosterols) by assessing changes in biochemical markers of bone     turnover and cardiovascular risk.   "
245949|NCT01074736|"     The identification and characterization of susceptibility loci for H5N1 infection in humans     could have profound implications. The detection of host genetic factors may shed light on key     pathogenic interactions between H5N1 and human cells, assisting in identifying the viral     characteristics determining pandemic potential. In addition, the identification and     verification of susceptibility loci would be followed by functional studies which might point     the way to new therapeutic and preventive options.      The objective of this study is to investigate if host genetic factors are associated with     susceptibility to influenza H5N1 illness   "
245950|NCT01074749|"     The aim of the study is the comparison of two different leads in their capabilities to detect     episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT),     and the rejection of far field sensing of the far field R-wave (FFRW).   "
245951|NCT01074762|"     The aims of a concluding 14-year follow-up study are:        -  To investigate what long-term effect the project model for structured, personalized          diabetes care has on 1) the patients' mortality and development of diabetic          complications, 2) the patients' use of services from the primary and secondary sector,          3) the patients' self-rated health and motivation, and 4) the doctor-patient          relationship.   "
245952|NCT01074775|"     The approach we will use is to employ measurement of the activation of white blood cells, to     look at patterns of responses during a controlled infection of the gut with Mycobacterium     bovis. M. bovis can be conveniently obtained in a safe and pure form as an oral vaccine. By     giving three challenges of M bovis to the gut, we will simulate repeated gut infections with     this organism. We can then compare the activation of cells in the blood to the immune     responses seen after each challenge, to determine whether the non-specific defences of the     gut can block each subsequent infection.   "
245953|NCT01074788|"     The main goal of geriatric rehabilitation following an acute illness is rapid restoration of     normal activity. The key elements are pain control, restoration of bowel functions, good     sleep quality, appetite and general well-being, as well as return to pre illness physical     capabilities. Emphasis has recently been placed on finding innovative multi-disciplinary     methods that can improve the care of elderly people who had suffered an acute illness. The     aim of this prospective study is to assess the effect of mind-body therapy(including guided     imagery, relaxation techniques, mediation and touch therapy) as as an adjunct to medical and     physical rehabilitation in geriatric patients.   "
245978|NCT01075113|"     This phase I trial is studying the side effects and best dose of vorinostat when given     together with sorafenib tosylate in treating patients with advanced liver cancer. Sorafenib     tosylate and vorinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth or by blocking blood flow to the tumor.   "
245954|NCT01074801|"     High variability of blood sugar levels and high incidence of night-time hypoglycaemia (low     blood sugar) in young people with type 1 diabetes (T1D) make achieving the treatment goals in     this population extremely challenging.      Our ongoing research focuses on the development of a closed-loop glucose control in children     and adolescents with T1D. The three components of the closed-loop system are a continuous     glucose monitor, an insulin pump, and a computer-based algorithm. The studies performed thus     far evaluated the efficacy and safety of overnight closed-loop glucose control. The results     showed that overnight closed-loop improved control of blood glucose and prevented nocturnal     hypoglycaemia, as compared to the conventional insulin pump therapy. The next objective is to     evaluate the efficacy and safety of closed-loop insulin delivery over a prolonged time     period, including the daytime, when normal living activities occur. This will pave the way     for a more comprehensive use of closed loop systems to control glucose levels in T1D.      The present study adopts an open-label, randomised, 2-period cross-over design whereby the     safety and efficacy of closed-loop insulin therapy will be compared with the conventional     insulin pump therapy in 12 adolescents with T1D. Participants aged 12 to 18 years will be     randomised for two 36 hour studies in a clinical research facility, during which glucose     levels will be controlled by either the computer-based closed-loop algorithm (intervention     arm) or by conventional insulin pump therapy (control arm). During both studies participants     will perform normal daily activities, i.e. playing, reading, snacking and physical activity.     On both occasions, the Actiheart, a combined heart rate and movement sensor will be used to     accurately quantify each subject's individual physical activity energy expenditure during the     36 hour study period and for 36 hours of free living during weekday.   "
245955|NCT01074814|"     The purpose of this study is to determine the response rate, that is the % of patients with     non-progression of their metastatic breast cancer after 4 months on treatment that was     selected by molecular testing and proteomics.   "
245956|NCT01074827|"     The objective of this study is to evaluate the effect of strength training for the lower     extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The     study is a randomized control trial with two groups and the intervention is 8 weeks of     intensive strength training or treadmill walking. Primary outcome measure is walking ability,     secondary outcome measures are balance, work economy and strength.   "
245957|NCT01074840|"     The purpose of this study is to find out if there is a way to treat children with peanut     allergy to help lower the risk of severe allergic reactions and also cause them to lose their     allergy to peanuts and to understand what happens to their immune systems when they have     viral infections while on therapy. The approach we will use to treat peanut allergy in this     study is a process called desensitization.      We think that children with a peanut allergy receiving peanut oral immunotherapy will be able     to eat more peanuts without having a reaction by the end of the study than they could eat at     the beginning. We also think that we will be able to measure changes in their immune system     and their immune system's response to viruses while they are on therapy.   "
245958|NCT01074853|"     Current asthma medicines include inhalers. A common inhaler used in asthma is called a     beta-agonist (for example salbutamol). They improve asthma symptoms by stimulating areas in     the human airway resulting in widening of the human airway. Although these drugs are useful     after the first dose, longterm use can cause worsening asthma symptoms.      Beta-blockers are the complete opposite type of medication. Just now they are avoided in     patients with asthma as after the first dose they can cause airway narrowing and cause an     asthma attack.      New research has suggested that long term use of beta-blockers can reduce airway inflammation     which can improve asthma control and improve symptoms.      This research was done in asthmatic patients who didn't need inhaled steroids to control     their asthma. What the investigators want to do is see if the same benefit of beta-blocker     use is asthma can be seen in people who take inhaled steroids.   "
245959|NCT01074866|"     The present study aims to compare various parameters reflecting patient-ventilator synchrony     during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a     group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory     failure of various origin.   "
245960|NCT01074879|"     The mail goal of this randomized controlled, dietary intervention study is to investigate     whether protein supplementation in combination with resistance exercise can increase muscle     mass and strength in elderly. Loss of muscle mass and -strength is frequent in this group.     Participants (N = 220, equal distribution between men and women) are randomized to one of     three groups receiving different quantities and qualities of protein supplementation after     exercise. The results of this study will be used to form recommendations regarding diet and     exercise for the prevention of this frequent health problem in elderly.   "
245961|NCT01074892|"     Randomized controlled multi-center study with three arms including 200 patients with low risk     endometrial hyperplasia. After confirmed diagnosis the patients will receive one of the     following treatments:        1. Provera (Medroxyprogesterone (MPA)/progestin) 10 mg per oral treatment for 6 months 10          day each cycle,        2. MPA 10 mg continuously for 6 months,        3. Mirena (Levonorgestrel) impregnated IUD for 6 months.   "
246020|NCT01075659|"     A comparison of two products for oral nicotine replacement with respect to relief of urges to     smoke after single doses of nicotine.   "
246021|NCT01075672|"     To examine the effectiveness and clinical care outcomes of cognitive-behavioral therapy     interventions at Massachusetts General Hospital (MGH).   "
245962|NCT01074905|"     This is a randomised open label trial with follow up for 1 year. 660 adults and children     above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either     chloroquine, artesunate, or chloroquine/primaquine therapy. Participants will be screened on     the day of inclusion then followed weekly for 8 visits and every 4 weeks until week 52. The     primary objective of the study is to compare the efficacy of the WHO and Thai Ministry of     Public Health recommended radical curative regimen of chloroquine and primaquine with the     currently used monotherapy regimens of chloroquine and artesunate along the Thai-Burmese     border.   "
245963|NCT01074918|"     The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium     Chloride on blood pressure among patients with pre-hypertension or mild hypertension. We will     also test whether Potassium Magnesium Citrate increases excretion of large amounts of sodium     in the urine.   "
245964|NCT01074931|"     This post-marketing observational study is conducted for obtaining data on clinical,     biological and virological outcomes, compliance and tolerability of using a     lopinavir/ritonavir (LPV/r) -containing regimen for the treatment of naïve or experienced     patients infected with human immunodeficiency virus type 1 (HIV-1) in China.      Although LPV/r is frequently used world-wide, the evaluation of the outcomes, compliance, and     tolerance of anti-HIV strategies in real life is still a major challenge in the management of     HIV-infected patients who are on a life-long therapy, especially in China.      This study will help to develop effectiveness and safety profile of the lopinavir/ritonavir     containing regimen in Chinese HIV-1 infected patients, provide more choices of anti-HIV-1     strategies to Chinese experts and benefits Chinese HIV-1 infected patients.   "
245979|NCT01075126|"     It is hypothesized that Depakote will be better tolerated then lithium in treating African     Americans with bipolar disorder.   "
245965|NCT01074944|"     The primary objective of this study was to evaluate the efficacy and safety of once daily     (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in participants     with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of     eliglustat tartrate (Genz-112638). The secondary objective was to evaluate the     pharmacokinetics (PK) of Genz-99067 when eliglustat tartrate (Genz-112638) was administered     QD and BID in participants with Gaucher disease type 1 who had demonstrated clinical     stability on BID dosing of eliglustat tartrate (Genz-112638).   "
245966|NCT01074957|"     Background: Although respiratory physiotherapy has been used in patients undergoing cardiac     surgery, evidence lacks concerning its effectiveness. The aim of this study was to evaluate     the efficacy of three physiotherapeutic protocols used to recover respiratory volumes in the     postoperative period.      Methods: Thirty five patients were randomly allocated into three groups. Exercise group (E)     was oriented to progressive mobilization. Incentive Spirometry group (IS) performed deep     breathings using VoldyneTM, while Breath-Stacking group (BS) performed successive inspiratory     efforts using a facial mask adapted to an unidirectional valve. Both BS and IS also performed     progressive mobilization. Forced spirometry was carried out in the pre-operative period and     from the first to the fifth postoperative day. Statistical analysis used student t-test and     ANOVA, and the differences were considered significant when p<0.05.   "
245968|NCT01074983|"     The intent of this study is to describe the proportion of trauma patients requiring oxygen     before hospital arrival, the amount of oxygen they require, and whether or not the oxygen is     beneficial to outcomes.   "
245969|NCT01074996|"     A randomized , open-label, multicenter, phase II study to compare the efficacy of S-1 and S-1     plus Leucovorin as second line treatment on gemcitabine-refractory patients with inoperable     or advanced pancreatic cancers，investigate the correlation between efficacy and the     expressions of thymidylate synthase, dihydropyrimidine dehydrogenase and orotate     phosphoribosyltransferase   "
245970|NCT01075009|"     Antibiotic resistance in gram-negative bacteria continues to increase in US hospitals. This     comes at a time when there are few new drugs in development that are active for these     resistant organisms. The implication is that we must learn to use the drugs that we have more     wisely and develop new strategies that will preserve existing agents. Antimicrobial     stewardship programs are one strategy that many hospitals are adopting to improve the     quality of antimicrobial use. The goal of this project is to develop a consortium of US     academic medical centers that will allow characterization of the relationships between     antibiotic use and rates of resistance for gram-negative pathogens, and to help hospital     devise new strategies that will modify antibiotic use and possibly delay or reduce     resistance.      The specific hypotheses are:        -  Hospitals with established or emerging resistance in gram-negative pathogens, including          extended spectrum beta-lactamase (ESBL) producing organisms, carbapenem-resistant          enterobacteriaceae (CRE)and carbapenem-resistant P. aeruginosa have a different pattern          of antimicrobial drug use compared to hospitals with fewer of these organisms.        -  Hospital use of ertapenem is not associated with the rates of carbapenem-resistant          organisms.   "
245971|NCT01075022|"     A Prospective Double-Blinded, Placebo Controlled, Randomized Trial comparing a single dose of     Vitamin D (Colecalciferol) 300.00UI to placebo on patients with insulin resistance. Primary     Outcome: Blood glucose and homeostasis model assessment for insulin resistance (HOMA-R) after     90 days. Study hypothesis: Vitamin D treatment may improve insulin resistance and decrease     glucose level, since there is an association between hypovitaminosis D and increased insulin     resistance.   "
245972|NCT01075035|"     The purpose of this study is to determine whether the brains of persons with and without     traumatic brain injury differ in a meaningful way when advanced technology images of the     brain are taken using three newer technologies that visualize the brain using a combination     of external/internal magnetic fields and radioactive tracers (molecules that emit detectable     particles). The hope is that the results of this study will validate tools (help prove that     diagnostic tools actually detect disease) for the diagnosis and treatment of traumatic brain     injuries (TBI).   "
245973|NCT01075048|"     ARQ 197 or placebo in combination with irinotecan and cetuximab in patients with metastatic     colorectal cancer (CRC), in subjects with wild-type KRAS alleles who have failed front-line     systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the     recommended dose for Phase 2.   "
246022|NCT01075685|"     The purpose of this study is to determine whether the investigators internet-based     intervention is effective to help hazardous drinkers reducing their alcohol consumption.   "
245974|NCT01075061|"     Mirror movements are involuntary, symmetrical and simultaneous movements occurring on one     side of the body that accompany controlateral voluntary movements. Congenital mirror     movements (CMM) are characterized by childhood onset and the absence of additional     manifestations. The aim of this study is to unravel the pathophysiology of the CMM that     remains poorly elucidated. The combination of imaging studies and neurophysiological studies     using transcranial magnetic stimulation in a homogeneous and relatively large group of     patient is likely to allow us to better understand the underlying pathophysiology of the     disorder. Using a linkage analysis approach we will try to identify a locus associated with     CMM and related candidate genes.   "
245975|NCT01075074|"     The use of pre-operative transversus abdominis plane block will reduce pain after outpatient     laparoscopic gynecological surgery and improve quality of recovery.   "
245976|NCT01075087|"     The use of preoperative TAP block in laparoscopic bariatric surgery can improve the     postoperative pain and quality of recovery in patients undergoing these procedures.   "
245977|NCT01075100|"     Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and     triple negative breast cancer. Ixabepilone has substantial antitumor activity in     taxane-refractory patients and novel combinations are needed in this poor prognosis     population. Carboplatin in combination with gemcitabine or paclitaxel has activity in     metastatic breast cancer (MBC); there is also demonstrated activity of the     gemcitabine/carboplatin combination in the ER+ versus triple negative subsets. A Phase I     study of ixabepilone plus carboplatin in solid tumor patients demonstrated the safety of this     combination at the doses and schedule proposed for this Phase II trial (BMS data on file).   "
245980|NCT01075139|"     Research has shown that a high percentage of college students do not meet recommended     national guidelines for physical activity or fruit/vegetable intake. The purpose of this     study was to pilot test the short-term efficacy of a one-on-one, brief motivational     intervention (BMI) designed to increase physical activity and fruit/vegetable intake. It was     hypothesized that participants in the BMI condition would report greater physical activity     and fruit/vegetable intake at follow-up than those in an education-only control condition.   "
245981|NCT01075152|"     The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal     meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital     discharge results in superior survival compared to standard initiation of ART started as an     outpatient.   "
245982|NCT01075165|"     In a burn population, conduct a prospective, double-blinded, randomized, controlled clinical     trial to determine the ability of spray silicone to alter the physical characteristics of     burn scar compared to a placebo.   "
245983|NCT01075178|"     Retrospective medical record review study of specific adverse events in children with     congenital heart disease who received palivizumab for prophylaxis of serious respiratory     syncytial virus infection and control subjects that did not receive palivizumab   "
245984|NCT01075191|"     Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human     Immunodeficiency Virus participants   "
245985|NCT01075204|"     The objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore     throat, and others), tolerability and compliance of treatment with clarithromycin once daily     in patients with upper or lower respiratory tract infections in the routine clinical     practice.   "
245986|NCT01075217|"     No significant differences is expected in observed motion artifacts, heat or pain reported     during peripheral DSA performed for diagnostic and/or endovascular therapeutic purposes.   "
245987|NCT01075230|"     The purpose of this study is to determine if there is a difference in hemoglobin level     between patients undergoing total knee arthroplasty with and without platelet-rich plasma.   "
245988|NCT01075243|"     GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol     1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic     efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The     duration of the entire study will be approximately 18 weeks. Each subject will have to come     to the clinic for three visits (Screening, Treatment and Follow up visits).   "
245989|NCT01075256|"     To evaluate the efficacy of two different concentrations of a tubule occlusion agent -     calcium sodium phosphosilicate in treatment of dentine hypersensitivity   "
245990|NCT01075269|"     Robotic assistance during thyroid surgery has been utilized clinically in Korea since late     2007. Robotic thyroidectomy has also been validated for surgical management of the thyroid     gland. Compared with endoscopic thyroidectomy, the use of a robot in an endoscopic approach     via the axilla provides a broader view of the thyroid bed, albeit from a lateral, as opposed     to the conventional anterior, perspective. The wrist action of a surgical robot also provides     a greater degree of movement than afforded by the use of simple endoscopic instruments, and     tremor is eliminated.      Although several reports on operative outcomes of the robotic technique have appeared, no     prospective trials comparing the clinical results of robotic with conventional open     thyroidectomy have been described. We therefore designed a prospective trial comparing     outcomes, including postoperative distress and patient satisfaction, between patients     undergoing robotic and conventional open thyroidectomy.   "
245991|NCT01075282|"     The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin     A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes.     Participants must also be taking metformin and glimepiride.   "
245992|NCT01075295|"     The purpose of this study is to determine whether individuals with psychotic spectrum     disorders ( Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar     Disorder (Type I),Bipolar Disorder (Type II),Major Depressive Disorder With Psychotic     Features,Substance-Induced Psychoses,Psychosis Not-Otherwise-Specified (NOS)randomly assigned     to a stepped behavioral intervention for the prevention of weight gain will experience less     weight gain than individuals who receive usual care. There are several studies that have     examined the effect of pharmacological and non-pharmacological behavioural approaches for     weight loss in patients with psychosis, however studies examining strategies for prevention     of obesity are lacking. This study is an important and novel approach to studying the problem     of obesity in those with psychosis.   "
245994|NCT01075321|"     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood     flow to the cancer. Giving everolimus together with lenalidomide may be an effective     treatment for lymphoma.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving     everolimus and lenalidomide together and to see how well they work in treating patients with     relapsed or refractory non-Hodgkin or Hodgkin lymphoma.   "
245995|NCT01075334|"     Many cases of male infertility are poorly understood and regarded as unexplained. Therefore,     a etiological treatment for this condition can not be offered in most cases. A beneficial     effect on sperm motility was found in trails using antioxidants such as carnitine, zinc and     folic acid. However, most studies lacked a sufficient power to detect a significant effect on     pregnancy rates. In this study, infertile men with abnormal sperm quality parameters will be     randomized to receive either carnitine-based food supplement (Porimore) or folate and Zinc     Tablets.   "
246005|NCT01075464|"     This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combination with     bevacizumab, and in combination with bevacizumab and paclitaxel as therapy for locally     advanced or metastatic solid tumors.   "
246006|NCT01075477|"     This observational study will assess the execution, efficacy and safety of treatment with     MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera     according to local treatment guidelines will be collected for 29 months. Target sample size     is 100-200 patients.   "
245996|NCT01075347|"     Ophthalmology ,cornea Autologous serum has long been known to be effective to promote corneal     epithelial wound healing in a variety of ocular surface disorders. However, its effectiveness     for corneal epithelial defects due to pars plana vitrectomy (PPV) for diabetic retinopathy     and penetrating keratoplasty has seldom been reported. In this study, we plan to perform a     prospective study to determine the effectiveness of topical autologous serum as a primary     treatment for corneal epithelial defect in patients undergoing vitrectomy for diabetic     retinopathy and penetrating keratoplasty. All patients enrolled in this study have received     corneal epithelial debridement at the end of the ocular surgeries, namely PPV for diabetic     retinopathy and penetrating keratoplasty. The patients were grouped into two treatment     groups. In the control group, the patients receive conventional postoperative eye drops     including topical steroid, antibiotic and mydriatics. In the experimental group, the patients     receive topical autologous serum eye drops in addition to conventional postoperative eye     drops. The duration for cornea surface to completely re-epithelize, the incidence of corneal     complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer,     corneal melting, sterile corneal ulcer, corneal neovascularization), and the incidence of     recurrent epithelial break down after initial epithelization will be compared between these     two groups. Patients undergoing PPV for diabetic retinopathy and penetrating keratoplasty     will be compared separately   "
245997|NCT01075360|"     Neuroblastoma (NB) is the most common malignant tumor of infancy. Approximately 60% of NB     patients are clinically diagnosed as the stage IV disease and have a very poor prognosis with     the 5-year survival rate no more than 30%. Molecular markers of NB have great impacts on the     tumor behavior. MYCN amplification is the most well-known marker to predict a poor outcome in     NB patients. However, how MYCN affects the NB cell behavior remains unknown. In our     preliminary studies, we performed a genome-wide analysis of the differential gene expression     in 10 NB tumors with MYCN amplification and 10 with normal MYCN copy number. We found that     aromatic hydrocarbon receptor (AHR) reversely correlated with the MYCN expression. This     relationship was verified in 83 NB tumor samples. In addition, positive AHR expression by     immunostaining of NB tumors predicted a favorable prognosis. These lines of evidence     demonstrate that AHR not only relates to the MYCN expression but also plays an important role     in the tumorigenesis of NB. Therefore in this project we aim at further studying the     relationship between AHR and MYCN. In addition, the possible role of AHR in the tumorigenesis     of NB will be clarified. Specifically, we propose a 3-year project with the following three     aims:      Aim I. Determine the molecular relationship between AHR and MYCN expression. AHR has been     shown to suppress the E2F1 expression. E2F1 reversely has been found to upregulate the     expression of MYCN. In our preliminary microarray study, we also found that the expression     E2F1 positively correlated with the MYCN expression but inversely correlated with the     expression of AHR. Therefore, NB cells will be transfected with AHR expression vector or AHR     siRNA, then the associated E2F1 and MYCN expression will be examined to clarify if AHR could     regulate MYCN expression via E2F1. Furthermore, the E2F1 levels will also be manipulated to     determine if the effect of AHR on MYCN depends on E2F1. In addition, the E2F1 expression in     NB tumor samples will also be examined to clarify its in vivo role.      Aim II. Determine the effect of AHR expression on the NB cell behavior. The baseline AHR     expression levels in several NB cell lines will be examined. AHR is then overexpressed by     gene transfection in NB cells. The cell proliferation, migration, and differentiation after     AHR overexpression are evaluated. Furthermore the AHR expression in normal neuron cells is     also examined, and suppressed by siRNA to if downregulation of AHR could lead to cancer     development.      Aim III. Determine if AHR could be a target of gene therapy for NB. NB cells with either     normal MYCN or MYCN amplification before and after AHR gene transfection are inoculated into     nude mice to demonstrate the effect of AHR expression on NB cells behavior in vivo. AHR is     then transfected into the wild type NB tumor to see if the tumor growth could be suppressed     by AHR expression. Then wild type tumor and tumors transfected with AHR are subjected     microarray analysis to compare with the human tumor data set for evaluation of gene     expression changes along with differential AHR expression. Altogether, our studies will not     only establish the relationship between AHR and MYCN, but also allow us to depict the     functional role of AHR-MYCN interaction in the tumorigenesis of NB.   "
245998|NCT01075373|"     Schizophrenia (SCH) is a devastating brain disorder with grave personal, family and social     cost. SCH is a complex and heterogeneous (both genetic and clinical) disorder with     oligogenetic endowed vulnerability risk of disease, which manifested as a clinical syndrome     comprised of positive, negative and cognitive symptoms in late adolescent or young adulthood     under the interaction with environmental stress. The fact that most positive psychotic     symptoms can be well controlled by dopamine-blocking antipsychotics substantiates that     dopamine hyperactivity is the pathophysiological model of SCH positive symptoms. This is the     dopamine model of SCH.      The presence of negative and cognitive symptoms has not being fully explained by the dopamine     model. The hypo-glutaminergic function was hypothesized to replace or to supplement the     dopamine pathological model. The hypo-glutaminergic state was due to a neurodevelopmental     disturbance in early-stage of life, and was coined as a pathophysiological mechanism of SCH.      The neurodevelopmental disturbance supports the hypo-glutamine model based on the     cytoarchitecture abnormality in glutamate-pyramidal cells and reduced gray matter volume. We     have found potential vulnerability genes of DISC1 and NRG1 in our Taiwanese SCH family     samples. These two genes have functions on neurodevelopmental process. Besides, we, the     investigators, also found two vulnerability genes of DRD2 receptor gene and COMT genes in our     Taiwanese SCH families. The dopamine neurotransmission disturbance could be another     pathophysiological mechanism of SCH.      With the awareness of confounding variables of antipsychotic treatment response revealed in     pharmacogenetic studies, such as drug metabolism related genes and plasma HVA level, we     intend to test the etiological genetic hypotheses in antipsychotic treatment response: (1)     The group of neurodevelopmental etiology with risk variations in DISC1 and NRG1 genes is of     poor treatment response group; (2) The group of pure hyperdopamine etiology with risk     variation in DRD2 receptor and COMT genes is of good treatment group.      The potential treatment response related biomarkers, which are directly or indirectly induced     by the etiological risk genetic variations, will be examined. These potential biomarkers     include homovanillic acid (HVA), glutamate, serotonin, cytokines, and signaling proteins, the     neurocognitive function, event-related evoked potential, Niacin skin test, and the AKT1 level     in the peripheral lymphocytes.      After obtained the informed consult, we'll recruit 30 drug-naïve early schizophrenia (first     episode or prodromal stage) patients for pre-treatment and post-treatment assessment on     treatment response using positive and negative syndrome scale (PANSS), changes in biomarkers     (including biochemical, electro-physiological and neuro-cognitive variables), and brain     imaging (studies of component Project No.2 of this Integrated Program) of PET, fMRI, MRI, DSI     and MRS (please refer to Project No.2) in addition to genotyping on DISC1, NRG1, DRD2 and     COMT genes. The treatment agent is the dopamine stabilizing agent (aripiprazole, 15mg/day for     4 weeks) taking the advantage of dopamine activity balancing effect. Besides, we'll recruit     30 normal controls matched with age, gender, and education, who will receive genotyping and     evaluations in all biomarker variables, and brain imaging studies.      In order to have adequate statistical power in the genetic analysis of 17 SNP variations in 4     vulnerability genes of DISC1, NRG1, DRD2, COMT, we'll recruit 200 more cases of schizophrenia     with duration of illness less than 5 years, who have received regular clinical follow up and     had good compliance on medication. The treatment response will be evaluated using PANSS.     These cases will also receive all biomarker examinations and genotyping studies. For     comparison, we'll also recruit 100 normal controls for study.      We'll delineate the heterogeneity issue of schizophrenia using genetic variation,     neurobiological biomarkers. This study result will be beneficial for understanding     pathogenesis of SCH, and for developing better treatment and prevention methods.   "
245999|NCT01075386|"     Endometrial cancer usually begins in the endometrium, which is the tissue lining of the     uterus. Endometrial cancer is the most commonly diagnosed gynaecological malignancy in     Australia. It affects 1 in 80 Australian women and there are about 1400 new cases and 260     deaths from the disease every year. Most affected women are aged between 50 and 70 years. The     purpose of this study is to investigate the possible role of the endocrine system in the     regulation of human endometrial cancer. By looking at the laboratory results of people with     endometrial cancer and also those without endometrial cancer we hope to gain a better     understanding of how endometrial cancer develops and progresses. This may lead to the     development of new, effective therapies for endometrial cancer.   "
246000|NCT01075399|"     This pilot phase II study is designed as a test and retest study to investigate [F 18]HX4 as     a reliable non-invasive PET imaging marker for detection of tumor hypoxia regions and to     establish a threshold for [F 18]HX4 uptake in the tumor. The study will evaluate the     relationship between hypoxia biomarkers (HIF1α and CA-IX) by immunohistochemistry (IHC) and     tumor uptake of [F 18]HX4 by PET imaging.   "
246001|NCT01075412|"     Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to     metabolically active tumor.      This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The     radiation plan is then designed to spare that area, in hopes of keeping the bone marrow     active during therapy. Bone marrow and tumor activity will be monitored using a sequence of     FLT PET scans during the course of chemotherapy and radiation therapy.   "
246002|NCT01075425|"     RATIONALE: Belinostat and bortezomib may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Giving belinostat together with bortezomib may kill more     cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of     giving belinostat together with bortezomib in treating patients with relapsed or refractory     acute leukemia or myelodysplastic syndrome.   "
246003|NCT01075438|"     Ataxia-telangiectasia (AT) is a rare genetic disorder characterized by gait disorders,     neuromotor dysfunction, eye abnormalities and immune deficiency. AT patients are vulnerable     to cancer and infection and usually die during their 2nd or 3rd decade due to these     complications. The main cause of death is respiratory infections because these patients are     known to have severe type of immunodeficiency. Consequently, pneumonia is the most common     infection seen in AT patients, and is usually caused by S. pneumoniae. Therefore, a routine     schedule of pneumococcal vaccine is highly recommended in AT cases where immunoglobulin     replacement therapy was not already initiated.      Until recently, AT patients were immunized with the pneumococcal polysaccharide vaccine     (PPV23, Pneumovax® Aventis Pasteur MSD). However, data have shown that they do not respond     well to these vaccines. Recently, the Israeli Ministry of Health has approved the     pneumococcal 7-valent conjugate vaccine (PCV7, Prevenar®, Wyeth Lederle) for AT patients of     all ages. This conjugate vaccine is known to stimulate the immune system through a different     mechanism and the response is expected to be higher. The approved Israeli schedule for     immunization of AT patients includes children older than 2 years that are entitled to receive     2 doses of PCV7 (8 weeks apart) boosted by PPV23, eight weeks after the second dose of PCV7.     Assessment of the antibody response of such pneumococcal vaccination protocol in AT patients     has never been performed.      The Safra Children's Hospital is the national multi-disciplinary center caring for AT     patients. Approximately 50 patients from all over the country (including Jewish, Druze,     Bedouin and other Muslim patients - 3 of whom are Palestinians) are followed in the clinic on     a monthly basis.      Approximately 20 AT patients are not receiving IVIG replacement therapy, therefore are     entitled to receive pneumococcal vaccination as stated above (mean age 10.6, 3 -23 years, 3     less than 5 years)      The aim of this study is to evaluate the responsiveness, determined by specific antibody     production, of AT patients receiving this new vaccine protocol.   "
246004|NCT01075451|"     The purpose of this investigation is to study the relationships between antimicrobial     stewardship program efforts, antimicrobial drug use, and infection control efforts to the     incidence rates of hospital acquired infections with Staphylococcus aureus in a sample of US     academic medical center hospitals.   "
246007|NCT01075490|"     This prospective, double blinded study investigates spinal anesthesia with or without     clonidine added to bupivacaine in newborns. This study is based on duration measurement of     spinal anesthesia and cardio respiratory recording during 24h for apnea detection.   "
246008|NCT01075503|"     Brachial plexus block is a frequently used technique for upper extremity surgery. All present     approaches and techniques have certain advantages and disadvantages. It's necessary to     develop a new approach to brachial plexus block which 1) provides reliable anesthesia, 2) is     easy to perform, 3) isn't restricted by posture, 4) provides extensive sensory distribution,     5) causes as few complications as possible, 6) easily place a secured catheter for     post-operative analgesia. The investigators established the retrograde infraclavicular     brachial plexus block approach. The investigators compared and verified the feasibility,     efficacy and safety of this new approach with other classic approaches to brachial plexus     block.   "
246009|NCT01075516|"     The purpose of the study is to define the economic value of implantable cardioverter     defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy. Aims     of the study are to develop a hospital cost minimization analysis and a cost effectiveness     analysis based on direct estimation of costs and quality of life deriving from remote follow     up (performed with Merlin@home and Merlin.net) compared to standard follow up in the     management of ICD implanted patients.   "
246010|NCT01075529|"     The purpose of this study is to identify what degree of symptom changes during the early     weeks could be used to predict eventual nonresponse at week 6 among depressive inpatients     taking fluoxetine.   "
246011|NCT01075542|"     The purpose of this study is to determine if Toric intraocular lens implantation in cataract     surgery is a more efficient and cost-effective treatment of astigmatism than Monofocal     intraocular lens implantation.   "
246012|NCT01075555|"     RATIONALE: Sorafenib tosylate and pravastatin may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of     liver cancer by blocking blood flow to the tumor. It is not yet known whether sorafenib     tosylate is more effective when given alone or together with pravastatin in treating patients     with liver cancer and cirrhosis.      PURPOSE: This randomized phase III trial is studying sorafenib tosylate given together with     pravastatin to see how well it works compared with giving sorafenib tosylate alone in     treating patients with liver cancer and cirrhosis.   "
246013|NCT01075568|"     To examine the satiety effect after eating of Okara.   "
246014|NCT01075581|"     Intranasal injection of epinephrine is used routinely during endoscopic sinus surgery (ESS)     to reduce bleeding in the nasal mucosa and thereby improve visualization of the surgical     field. However, systemic absorption of epinephrine via the nasal mucosa is often accompanied     by cardiovascular side effects during the early postinjection period, putting in risk     patients with cardiovascular morbidity. Evidence indicate that topical administration of     epinephrine achieves similar hemostatic effects compared with injection of epinephrine, while     avoiding systemic adverse effects. We wish to conduct a prospective controlled trial     assessing the hemostatic and hemodynamic effects of intranasal injection compared to topical     application of epinephrin during ESS, in order to evaluate whether the previous could be     avoided due to its untoward effects.      We hypothesize that topical administration of epinephrine provides a hemostatic effect not     inferior to that of intranasal injection while minimizing hemodynamic instability during ESS.   "
246015|NCT01075594|"     The purpose of this study is to establish the proportion of Bulgarian patients on     lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Fourth     Joint European Task Force guidelines.   "
246016|NCT01075607|"     The objective of this study is to identify and validate metastasis protein markers in lymph     collected from women with metastatic breast cancer. We will examine peripheral blood for the     presence of these identified markers in order to develop a user friendly clinical test to     detect metastasis and to evaluate response to therapy.   "
246017|NCT01075620|"     The purpose of this study is to determine if there are any clinical or radiographic     differences in non-posterior stabilized rotating mobile bearing design versus a posterior     stabilized rotating mobile bearing designs.   "
246018|NCT01075633|"     This study is aimed: 1) to compare the accuracy of colonoscopy vs immunochemical faecal     occult blood test (iFOBT) and colonoscopy when positive for colorectal cancer (CRC) screening     in familiar-risk population and; 2) to determine the complications associated with both     strategies.   "
246019|NCT01075646|"     The purpose of this study is to determine whether a continuous infusion of local anesthesia     with a catheter in the surgical wound reduces patient consumption of opiates by 30% in the     48-hour postoperative period following surgery for colorectal neoplasm and hepatic surgery     versus the continuous infusion of physiological serum.   "
246023|NCT01075698|"     The present research is conducted as a randomized, parallel-group, controlled, open study     (using the PROBE method) to primarily verify the effects on various biomarkers in high-risk     hypertensive patients treated with ARB (telmisartan, ARB group) as compared with those in     patients receiving ordinary therapy (non-ARB group (ordinary therapy group)). In addition,     onset of cardiovascular events and levels of markers that are associated with cardiovascular     events are observed over time to examine the significance of each marker. The biomarkers will     be obtained at the start of the study (at registration), after 6, 12, 24 and 36 months from     the start of the study.   "
246024|NCT01075711|"     Rheumatoid arthritis is the most common rheumatic disease with symptomatic morning stiffness     which entails a quite essential restriction in the everyday life and in the life quality.     This observational, uncontrolled, multicentric study is aimed to assess the improvement in     the activity status or QoL of subjects with RA being treated with the Tempus tablet.   "
246025|NCT01075724|"     Intraoperative active warming is usually performed by skin warming. There are several     forced-air systems on the market; forced air warming is generally described as the most     effective yet feasible method of patient warming.      Augustine Biomedical (Eden Prairie, MN, USA) recently introduced a new patient warming system     named Hot Dog with an active polymer warming upper-body blanket and a new under-body     warming mattress. The polymer-heating devices consist of an electronic regulator and the     polymer blankets, which are covered with a washable fabric. Conventional mains power the     system. The manufacturer claims, that the new system Hot Dog (with combination of under     body and upper body warming) is as effective as forced air warming, while not having any     disadvantages of the forced air system, like: airborne infection, noise, high power     consumption and hard-to-clean hose.      The investigators will compare the new Hot Dog patient warming device combination (under body     + upper body) with the established warming system, which blows warm air via a mattress over     the body of the patients).   "
246026|NCT01075737|"     This is an observational, non controlled, non-interventional, multicentric, prospective study     planned to be conducted in 450 subjects diagnosed with MS and their caregivers in 20 centres     of Argentina. The observations from this study will contribute to the awareness of the impact     on the Quality of Life (QoL) of the caregivers and, eventually will also provide measures for     helping the subjects with multiple sclerosis (MS) without leaving aside the care of the     physical and psychic health of those who work as caregivers.   "
246027|NCT01075750|"     In this study we want to show that the choice of a balanced type fluid solution for the     perioperative fluid management of patients receiving cadaveric renal transplantation results     in less occurrence of intra- and postoperative hyperkalemia, and thus the need for     postoperative dialysis. Additionally, we aim to determine whether the use of a balanced     infusion solution leads to less occurrence of metabolic acidosis and electrolyte disorders     than the use of isotonic saline.      Furthermore we want to evaluate whether perioperative fluid management with balanced infusion     solutions results in a higher frequency of primary graft function than with administration of     isotonic saline.      We will test the hypothesis that the use of Elomel isoton(Fresenius Kabi Austria GmbH) a     balanced infusion solution will result in less occurrence of hyperkalemia and consequent     post-transplant dialysis, less occurrence of metabolic acidosis, decreased incidence of     electrolyte disorders and higher incidence of primary graft function when compared to     isotonic saline for perioperative fluid management in patients receiving cadaveric renal     transplantation.   "
246028|NCT01075763|"     This was a 52-week, multicentric, phase II, pilot study conducted in 40 subjects with     early-onset Alzheimer's disease (AD) to evaluate safety, tolerability and clinical efficacy     of subcutaneous (sc) interferon (IFN) beta-1a [Rebif® 22 microgram (mcg), three times per     week (tiw)] in the treatment of AD by comparing the neuropsychological performance changes     into placebo and treatment arms from screening/baseline to 52 week.   "
246029|NCT01075776|"     To determine the effects of whether increasing CNP concentrations slightly above normal will     improve the functioning of blood vessels after the interruption in the flow of blood. In this     study we are looking at the function of the blood vessels of the forearm, as a substitute for     those in the heart   "
246030|NCT01075789|"     Nasogastric tube insertion is one of the most common invasive procedures performed in     children's hospitals, and has long been recognised as one of the most traumatic and painful.     As a once off procedure, a nasogastric tube insertion is extremely distressing but the     repeated procedures that many children endure as a necessary part of treatment for a chronic     disease can be so traumatic that psychological damage may occur. There have been a limited     number of studies carried out which have looked at methods to reduce the pain and trauma     associated with this procedure, but most of these have been carried out in the adult     population.      The investigators propose to carry out a research project in a paediatric setting to     definitively investigate the use of local anaesthetic spray, in combination with local     anaesthetic gel, to numb the nasal passages and the back of the throat, with the aim of     reducing or removing the unpleasant sensation of the nasogastric tube placement. If the study     shows a benefit from the use of local anaesthetics, it would be an inexpensive and easily     incorporated intervention that could be inserted into the routine procedure for nasogastric     tube insertion.   "
246031|NCT01075802|"     Tamoxifen is an important drug for the treatment of breast cancer. Used adjuvantly after     operation in early breast cancer, tamoxifen reduces annual recurrence rate by half and cancer     death by one third. Used preventatively it also reduces the risk of breast cancer by 50% in     women at high risk for developing the disease Tamoxifen needs to be activated in the body to     an active form called endoxifen, mainly by the enzyme called CYP2D6. Patients have variable     capability to activate tamoxifen due to variable function of this enzyme. Studies showed     clear correlation of specific genetic variant of CYP2D6 with endoxifen blood levels. It is     estimated that up to 25% Caucasian population have reduced or even absent CYP2D6 function.     More recently, there were studies that showed the correlation with genetic variant of CYP2D6     and breast cancer relapse in early breast cancer patients treated with tamoxifen. Food and     Drug Authority (FDA) in America and recommended checking CYP2D6 genotype in patients     receiving tamoxifen treatment, but they did not specify how to interpret the genotype results     and what kind actions to take in patient with adverse genotype. The aim of the investigators     study is to see if increasing tamoxifen in patients with genetic polymorphism of CYP2D6 will     increase endoxifen level to the same range of most patients who have wild type (normal     functional)CYP2D6.   "
246032|NCT01075815|"     This is a multicentric, open, randomized, comparative trial aimed to assess the influence of     recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation     (COS) in advanced reproductive age in terms of improved embryo competence which allows to     transfer less embryos to avoid high grade multiple pregnancy without reducing the pregnancy     rate.   "
246056|NCT01076127|"     Neck/shoulder and back pain is quite common among employees in sedentary occupations.     Furthermore, many have a low level of fitness. Strength training with dumbbells has been     shown to alleviate neck/shoulder pain, but many people prefer to also have alternative     training options. Empirically, kettlebell training works the neck/shoulder/back while at the     same time training the cardiovascular system. This type of training has not previously been     tested in a randomized controlled trial. The aim of this study is to test the effect of     kettlebell training on musculoskeletal pain, fitness, and muscle strength.   "
246033|NCT01075828|"     After consultation with the Korean Health Authorities, the two Post-Authorization Safety     Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one     study protocol EMR 062202-551. This Post-Marketing Surveillance Study (PMS) EMR 062202-551 is     requested by the Korean Health Authorities to continue monitoring of Erbitux and provide     further information about safety and toxicity in clinical practice in at least 900 patients     during 6 years.      All data points from the EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) remain     unchanged in protocol EMR 062202-551. Therefore, the Sponsor has decided not to separately     disclose the EMR 062202-551 study titled A Korean Post-Marketing Surveillance Study On     Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic     Squamous Cell Cancer of the Head and Neck (originally EMR 62241-508) and in Patients With     EGFR-expressing, KRAS wild-type Metastatic Colorectal Cancer (originally EMR 62202-509) on     clinicaltrials.gov.   "
246034|NCT01075841|"     This is a prospective post-marketing surveillance (PMS) study to collect safety information     from more than 600 subjects with recurrent and/or metastatic squamous cell cancer of the head     and neck (SCCHN) treated with Erbitux as final evaluable cases. This PMS study is requested     by the Korean Regulatory Authorities. After approval of new indication in Korea, there is a     requirement to investigate more than 600 subjects during six years, to continue monitoring     and provide further information about safety and toxicity in clinical practice.   "
246035|NCT01075854|"     This is a prospective, observational study in women using Gonal-F filled-by-mass (FbM) in     ovarian hyperstimulation as part of their in-vitro fertilization (IVF) or intracytoplasmic     sperm injection (ICSI) treatment at infertility clinics in Korea. The purpose of this study     is to assess Gonal-F FbM in a practical setting encompassing all subject groups and local     practices.   "
246036|NCT01075867|"     To demonstrate the effectiveness of the ELIPS programme (Multi-dimEnsionaL preventIon Program     after Acute coronary Syndrome), which aims at improving quality of care of patients admitted     to hospital with Acute Coronary Syndrome (ACS) in the Swiss setting. The program targets an     increase in prescription rates by physicians and long term medication adherence and adoption     of healthy lifestyle attitudes by patients.      The program is dedicated to caregivers to increase their application of guidelines into     practice, to increase their confidence in therapeutic education of patients, and to patients     to improve their understanding of ACS and its treatment and to increase their motivation for     long term treatment,.   "
246037|NCT01075880|"     The study is planned to evaluate the cognitive functions in subjects with RRMS treated with     interferon beta-1a, and its relationship to the fatigue and neurological dysfunction status.   "
246038|NCT01075893|"     Colorectal cancer is a common disease worldwide. Increasing evidence is demonstrating that     colorectal cancers arise from 'cancer stem cells.' Stem cells in the colon reside at the     bottom of thousands of microscopic crypts throughout the wall of the colon. They create all     the cells lining the bowel wall. These cells are created in the base of the crypt and ascend     to the top acquiring the characteristics of mature cells of the bowel wall as they ascend.      It is now thought that colorectal cancer cells arise from stem cells where the genetic     material regulating growth and division of the stem cell has become defective. This leads to     unregulated production of cells which in turn have defective genetic information and cancer     formation.      Prior studies have demonstrated that the earliest changes before a cancer develops are     changes in cellular proliferation. Now that reliable markers to identify stem cells have been     found, the researchers aim to investigate stem cell numbers and changes in distribution in     those at normal risk of colorectal cancer and those at higher risk. The researchers     hypothesise that changes in cellular proliferation at the top of the crypt in individuals at     higher risk of colorectal cancer are due to a change in the number of stem cells in the crypt     base.   "
246039|NCT01075906|"     Colchicine is widely recognized as safe and effective treatment of Familial Mediterranean     Fever (FMF) in children and adults. Colchicine is currently used to treat FMF in younger     patients by inexact dosing through breaking or crushing adult-dose tablets. An     age-appropriate sprinkle formulation will allow for more accurate dosing in pediatric     patients. The primary objective of this study is to evaluate and compare the steady-state     pharmacokinetics of multiple oral doses of colchicine sprinkle capsules administered to     pediatric and adult FMF patients.      Secondary objectives include evaluation of the safety and tolerability of this regimen in     pediatric and adult FMF patients and measurement of the levels of acute phase reactants (i.e,     serum amyloid A [SAA], erythrocyte sedimentation rate [ESR], C-reactive protein [CRP]) at     baseline and after dosing.   "
246040|NCT01075919|"     To date, only a small handful of studies have assessed the effects of omega-3 polyunsaturated     fatty acids (n-3 PUFAs) on cognitive function in healthy adults. The results from these     studies are mixed, and have differed greatly in terms of methodology as regards sample size,     treatment formulation and duration of the intervention. In order to address these issues, the     present study aims to assess the effects of two different formulations of fish oil in     parallel, and at doses consistent with the current recommended daily intake of oily fish,     across a range of cognitive domains. The aim of the present investigation is therefore to     specifically evaluate the effects of 12 weeks supplementation of DHA-rich fish oil and     EPA-rich fish oil dietary supplements on cognitive function in healthy young adults     maintaining a regular diet containing oily fish not more than once a week. Self-report mood     assessments will form the secondary part of this investigation.   "
246041|NCT01075932|"     DHA has previously been shown to increase regional cerebral blood flow response to tactile     stimulation in aged monkeys; modulation of cerebral blood flow in humans has yet to be     demonstrated. Given that the brain relies on a constant supply of blood-borne metabolic     substrates (e.g. glucose, oxygen), increasing regional cerebral blood flow may also have an     impact on cognitive function. The current study aims to investigate the effects of two doses     of DHA-rich fish oil on task-related cerebral hemodynamic response and cognitive performance     in healthy adults.   "
246042|NCT01075945|"     Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine   "
246057|NCT01076140|"     The purpose of this study is to directly compare the blood pressure (hypertension) reduction     effects of lisinopril and nebivolol in patients who develop new onset or worsening     hypertension while treated with bevacizumab.   "
246058|NCT01076153|"     The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery     time in Thai patients with upper or lower respiratory tract infections.   "
246043|NCT01075958|"     To date, the relationship between omega-3 polyunsaturated fatty acids (n-3 PUFAs) in     cognitively intact individuals has only been examined in a limited number of studies; it is     at present unknown whether supplementation with n-3 PUFAs can improve cognitive function and     mood in this population. Further to this, it still remains to be established whether a     relationship exists between peripheral fatty acid status—reflective of dietary n-3 PUFA     intake—and cognitive function in this population. The current study therefore aims to address     this issue by exploring the relationship between serum PUFAs and specific cognitive functions     in a sample of healthy adults. To this end, participants will complete a range of cognitive     tasks evaluating performance across the domains of attention, memory and executive function.     Self-report mood assessments will be included as secondary measures.   "
246044|NCT01075971|"     This is a multi-center, open-label, preference study of two sublingual formulations of     buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy.      The objectives of this study are to evaluate the overall preference between two buprenorphine     sublingual formulations, after a switch from the marketed tablet (Subutex®) to the new fast     dissolving tablet (FDT), in opioid-dependent patients with buprenorphine 8 mg or 16 mg daily     maintenance therapy.   "
246045|NCT01075984|"     The purpose of this study is to collect pharmacokinetic (PK) information related to how well     intravenous Posaconazole (POS IV), is distributed in the body and to determine the safety and     tolerability of this new formulation. In addition, the PK, safety, and tolerability of     switching from taking POS IV to taking Posaconazole Oral Suspension (POS Oral) will be     evaluated. The data collected in this study will be compared to data collected in previous     studies.      Individuals who have been diagnosed by their physicians with a blood disease or cancer that     can affect their infection-fighting white blood cells will be asked to participate in the     trial. Since these blood diseases and their treatments can weaken the immune system, they may     put these individuals at a high risk for getting a serious fungal infection of their internal     organs or blood (invasive fungal infection). As these fungal infections can be hard to detect     early and can be life-threatening, many physicians believe that individuals diagnosed with     these diseases should receive antifungal therapy to try to lower their risk of getting this     type of infection.      Enrollment into this study will take place in several stages (cohorts). The determination of     which cohort an individual will be asked to participate in is based on which cohort is open     at the site at the time the individual is approached to consider study participation.   "
246046|NCT01075997|"     The purpose of the study is to determine whether having a video cell phone that gives daily     reminders over a 6-month period to check blood surgery and take your diabetes medications can     improve your diabetes control during that time and if that benefit lasts for up to 1 year.   "
246047|NCT01076010|"     Open-label, multi-center extension treatment protocol to allow access to tivozanib and     sorafenib for subjects who have participated on the AV-951-09-301 protocol. Eligible subjects     who were randomized to receive sorafenib on AV-951-09-301 and had documented progression of     disease will receive a tivozanib dose of 1.5 mg/day. Eligible subjects who were randomized to     tivozanib or sorafenib in AV-951-09-301, and displayed clinical benefit and acceptable     tolerability to treatment, will continue to receive tivozanib or sorafenib at the same dose     and schedule as in AV-951-09-301.   "
246048|NCT01076023|"     This study is designed to assess the incidence of cardiovascular events occurred within an 12     month follow up period in type 2 diabetic patients with either high risk of cardiovascular     disease (CVD) or history of coronary artery disease (CAD) or stroke.   "
246049|NCT01076036|"     An open-label, prospective, single-arm study is designed to evaluate safety, clinical and     technical efficacy of the CorPath 200 System in delivery and manipulation of the coronary     guide wires and balloon/stent systems for use in robotically-assisted, percutaneous coronary     intervention (PCI) procedures.   "
246050|NCT01076049|"     Does irrigation with IrriSept prevent infected wound progression when compared to usual care?   "
246051|NCT01076062|"     Primary outcome: to evaluate the effect of elective induction of labor (IOL), at 39 weeks     gestation, on cesarean delivery rates in nulliparous women compared to expectant management     (EM).      Secondary outcomes: to evaluate differences in the mean number of clinic visits/antepartum     tests avoided with IOL, to compare the differences in utilization of inpatient resources     (mean duration of inpatient stay, mean duration of labor), and to evaluate the effect of IOL     on the risk of urinary/anal incontinence and sexual dysfunction as analyzed using previously     validated measurements. We will evaluate differences in the rate of cervical change once     active labor is diagnosed, and the time from completion of active labor, defined as complete     dilation and complete effacement, to the delivery of fetus (definition of second stage of     active labor). Furthermore, other secondary outcomes to be evaluated include comparisons     between IOL and EM in regards to the occurence of chorioamnionitis, stillbirth, operative     vaginal delivery, and meconium stained amniotic fluid. An evaluation of the predictive value     of cervical length and Bishop score for vaginal delivery will also be examined.   "
246052|NCT01076075|"     This study will evaluate whether the addition of Sitagliptin treatment provides a greater     decrease in A1C levels compared to placebo in participants with inadequate glycemic control     on sulfonylurea and metformin combination therapy.   "
246053|NCT01076088|"     This study will assess the efficacy and safety of initial treatment with sitagliptin and     metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that     after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided     greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin     alone and with metformin alone.   "
246054|NCT01076101|"     This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These     unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood     sample.   "
246055|NCT01076114|"     The purpose of this study is to evaluate if critical flicker fusion is a more reliable method     for detection of early glaucoma compared to automated visual fields in comparison to subjects     without evidence of glaucoma or optic nerve disease.   "
246059|NCT01076166|"     Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children     with lower respiratory tract infections.   "
246060|NCT01076179|"     The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir)     in combination with new substances such as integrase inhibitors (INIs), C-C chemokine     receptor type 5 (CCR5) antagonists, and new non-nucleoside reverse transcriptase inhibitors     (NNRTIs), as there are many reasons (intolerability, complex resistant patterns or even     personal reasons) which may result in a change from the daily clinical routine and lead to     the use of a newly approved antiretroviral agent in combination with Kaletra.   "
246061|NCT01076192|"     The purpose of this study is to evaluate the effectiveness and safety of adalimumab as used     in routine clinical practice in adult patients with moderate to severe chronic plaque     psoriasis in Spain.   "
246063|NCT01076218|"     The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the     FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to     the system algorithm and minor changes to the user interface and sensor delivery unit, such     as adhesive sterilization method. It is anticipated that information collected will be     submitted as a supplement to Premarket Approval Application (P050020) to the US Food and Drug     Administration for approval to market this version of the system.   "
246064|NCT01076231|"     RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause     less damage to normal tissue in patients with non-small cell lung cancer. Drugs used in     chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving proton     beam radiation therapy together with combination chemotherapy may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of proton beam     radiation therapy when given together with cisplatin and etoposide and to see how well it     works in treating patients with stage III non-small cell lung cancer that can be removed by     surgery.   "
246065|NCT01076244|"     This is a single-center study evaluating the outcomes of patients with painful lumbar spinal     stenosis who were treated with the mild procedure (minimally invasive lumbar decompression.     The patients will be followed for 6 months after the procedure.   "
246066|NCT01076257|"     This research centers on the comparison of the immediate efficacy (right after therapy) and     the maintained efficacy (3 months and 6 months) between Modified Constraint-Induced Movement     Therapy (mCIMT) group and control group at different age.   "
246067|NCT01076270|"     RATIONALE: Giving chemotherapy and total-body irradiation (TBI) before a donor peripheral     blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor     are infused into the patient they will help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as     filgrastim (G-CSF) and plerixafor, to the donor helps the stem cells move (mobilization) from     the bone marrow to the blood so they can be collected and stored.      PURPOSE: This clinical trial is studying giving plerixafor and filgrastim together for     mobilization of donor peripheral blood stem cells before a peripheral blood stem cell     transplant in treating patients with hematologic malignancies   "
246068|NCT01076283|"     This pilot trial has the goal to demonstrate the feasibility of a study to test the effects     of baclofen in a laboratory experiment using cue-reactivity and alcohol-self administration     paradigms in non-treatment seeking alcohol-dependent subjects.   "
246069|NCT01076296|"     This study is to collect data and learn more about the Vscan Ultrasound Imaging System. It is     an observational study with no additional procedures or intervention prescribed other than     using the Vscan along with a routine medical physical exam.   "
246070|NCT01076309|"     The purpose of this study is to determine whether corneal endothelium cell loss during     cataract surgery is higher in patients taking Tamsulosin.   "
246071|NCT01076322|"     This is an open-label, randomized, cross-over, active-controlled study to evaluate the     efficacy and safety effects using Meptin® Swinghaler and Ventolin® MDI in stable asthma     patients.   "
246072|NCT01076335|"     The goal of this clinical research study is to find out if a therapy using docetaxel     chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to     treatment of prostate cancer. The safety of this combination will also be studied.   "
246073|NCT01076348|"     Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted     within Medtronic's System Longevity Study (SLS).   "
246074|NCT01076361|"     The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968     lead. This study is part of the Medtronic System Longevity Study.   "
246075|NCT01065155|"     Diabetic patients show an increased prevalence of non dipping arterial pressure pattern,     target organ damage and elevated arterial stiffness. These alterations are associated with     increased cardiovascular risk.      The objectives of this study are the following: to evaluate the prognostic value of central     arterial pressure and pulse wave velocity in relation to the incidence and outcome of target     organ damage and the appearance of cardiovascular episodes (cardiovascular mortality,     myocardial infarction, chest pain and stroke) in patients with type 2 diabetes mellitus.   "
247705|NCT01091883|"     The goal of this study is to collect comparative data on safety and efficacy of MR Guided     Focused Ultrasound and External Beam Radiation for treatment of metastatic bone tumors or     multiple myeloma.   "
246076|NCT01065168|"     The purpose of this trial is to study ovarian reserve after laparoscopic endometrioma     cystectomy by measuring antimullerian hormone. The measurements were measured before the     surgery and one week and three months after the surgery.   "
246077|NCT01065181|"     The purpose of this study is to document the rates of youth baseball player demographics,     incidence of arm pain, usage of different pitch types, and degree of internal rotation     contracture in the throwing versus the non-throwing shoulder. We followed a subgroup of     players for a year to see if a particular stretch would help reduce the internal rotation     contracture.   "
246079|NCT01065207|"     The investigators have previously described a limited group of HIV-1-infected patients, we     called HIV controllers (HIC), who have been infected for more than 10 years, in whom viral     replication is spontaneously controlled without any treatment. These patients are defined     according to virological criteria: more than 90% of the quantifications of plasma viral load     should be less than 400 RNA copies/mL. The purpose of the ANRS EP36 study was to characterize     these patients.   "
246080|NCT01065220|"     The aim of this study is to prove the influence of the sex steroid hormones estrogen,     progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron     emission tomography (PET) and the selective radioligand [11C]DASB. Specifically, the 5-HTT     binding will be quantified before and after hormone therapy underwent by 10 male-to-female     (MtF) and 10 female-to-male (FtM) transsexuals urging for hormone treatment. The high-level,     long-term administration of opsite sex steroid hormones in transsexuals provide the unique     opportunity to investigate the influence of sex steroid hormones on the serotonergic system.     Since the serotonin transporter serves as a primary target molecule for antidepressant     treatment, the results of the study will be of benefit for the assessment of the clinical     relevance of estrogen and testosterone as modulatory and neuroactive agents.   "
246081|NCT01065233|"     Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC     could be linked with multiple functional region of genome.      The determining of a genomic mapping of  single nucleotide polymorphisms  (SNPs) permit to     perform some genetic link studies with pathologies without clear hereditary disposition.      In this study, the investigators will identify predictives genetic polymorphism of HCC.   "
246082|NCT01065246|"     This phase II single arm, open-label study investigate the safety of a second cycle of     catumaxomab in patients with malignant ascites due to carcinoma, requiring their first     therapeutic puncture after treatment in the CASIMAS study.   "
246083|NCT01065259|"     The objective of this study is to compare the effect of Concerta (Osmotic Release Oral System     Extended Release Methylphenidate HCL, OROS MPH) and Strattera (Atomoxetine) on the laboratory     and ecological executive function in children with attention deficit hyperactivity disorder.   "
246084|NCT01065272|"     The investigators hypothesized that oral Dexamethasone in addition to nebulized Salbutamol     will improve the Bronchiolitis Clinical Severity Score,duration of treatment in the short     stay unit,need for hospitalization and readmissions to the pediatric emergency in a subgroup     of patients diagnosed as Bronchiolitis with either eczema and or a parental or sibling     history of Asthma.      Two groups randomized will be given Nebulized Ventolin plus either oral Dexamethasone or     placebo for 5 days.      Bronchiolitis severity score plus vital signs will be recorded regularly until patient is fit     for discharge.      Patients will be discharged on Ventolin inhaler and to complete the five days course of oral     Dexamethasone Patients will be followed up for 7 days post discharge by telephone.   "
246085|NCT01065285|"     The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against     influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.   "
246086|NCT01065298|"     The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus     patients.   "
246087|NCT01065311|"     The propose of the study is to investigate the efficacy of Mindfulness-based Cognitive     Therapy (MBCT, Segal, Williams, & Teasdale, 2002) for patients suffering from Chronic Major     Depression. The efficacy of MBCT will be compared with the Cognitive Behavioral Analysis     System of Psychotherapy (McCullough, 2003), a treatment approach, which has proven it's     efficacy yet, and with a treatment-as-usual condition (standard psychiatric outpatient care).   "
246088|NCT01065324|"     1. Balloon-assisted enteroscopy (BAE) is a new tool to investigate small intestinal          diseases.        2. Deep enteroscopy made possible by balloon expansion and manipulation of small          intestines.        3. However, whether intestinal barrier injured during BAE predispose patients to bacteremia          or clinical relevant infection is not studied.        4. We will also examine relevant patient factors.   "
246089|NCT01070680|"     In this pilot prospective non-commercial clinical trial the investigators will study the use     of dexmedetomidine as an adjuvant to the patient-controlled propofol sedation in a     placebo-controlled and randomized manner in patients with drug addiction during Endoscopic     Retrograde Cholangiopancreatography (ERCP). Dexmedetomidine is a sedative medication used     mostly in intensive care units,and is marketed under the brand name Precedex. Dexmedetomidine     has sedative, analgesic, sympatholytic, and anxiolytic properties. It produces sedation     without causing significant respiratory depression. Recent research has suggested     dexmedetomidine to be effective in treatment of alcohol withdrawal signs. In previous studies     dexmedetomidine was insufficient as an only sedative agent in ERCP and colonoscopy, but it     has not been assessed for sedation in patients with chronic pancreatitis. The main objective     of this trial is to evaluate if dexmedetomidine can reduce propofol and opioid consumption     and facilitate the performance of ERCP in patients with chronic pancreatitis due to drug     addiction.Secondary objectives of the trial are the stability of vital signs and safety,     patients´ satisfaction plus recovery time from sedation.      50 elective ERCP patients with chronic pancreatitis after written informed consent and     randomisation will be recruited to the study. Exclusion criteria are:allergy to propofol,     opioid or dexmedetomidine, ASA class greater than 3. All the patients will receive     patient-controlled propofol sedation. In dexmedetomidine group dexmedetomidine infusion will     be started before sedation beginning and in placebo group placebo-solution (NaCl0,9%) will be     administered in the similar manner.Standard monitoring for vital signs will be applied,also     sedation degrees will be evaluated with sedation scores. At the end of procedure total amount     of propofol and opioid will be calculated,patients and endoscopists satisfaction and the     difficulty of ERCP will be assessed.   "
246090|NCT01070693|"     This randomised prospective study was designed to compare the convalescence and the long-term     sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene     Hernia System®) or an onlay mesh applied according to Lichtenstein.   "
246091|NCT01076374|"     The primary purpose of this study is to assess the long term reliability of the Medtronic     Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of     approval of nEw3 devices. Patients will be followed for 5 years after implant. This study     utilizes data collected from the System Longevity Study (SLS).   "
246092|NCT01076387|"     The purpose of this study is to determine if using robotic surgical technology during bladder     cancer surgery helps to reduce complications during and after the surgery. The removal of the     bladder and lymph nodes will be done by a robotic or by an open technique. It may be a     Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an     Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.   "
246623|NCT01079767|"     RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients     with advanced liver cancer and cirrhosis.   "
246093|NCT01076400|"     This study will be conducted in two parts. Part 1 will determine whether administration of     MK1775 in combination with topotecan and cisplatin is generally well-tolerated and causes     clinical objective responses in patients with cervical cancer. Part 1 will also define the     recommended Phase 2 dose and maximum tolerated dose (MTD) of the combination of MK1775 with     topotecan and cisplatin. Part 2 of the study will evaluate whether treatment with MK1775 in     combination with topotecan and cisplatin causes an improvement in progression-free survival     (PFS) compared to treatment with topotecan and cisplatin alone and will further evaluate the     tolerability of the combination treatment.   "
246094|NCT01076413|"     The purpose of this research study is to compare two different exercise treatments for     walking problems in older adults. The investigators want to determine if participation in the     exercise programs for 3 months will improve walking abilities by improving balance and     strength.   "
246095|NCT01076426|"     The purpose of this study is to determine whether probiotics can improve the nutrition status     and prevent peritonitis in the chronic peritoneal dialysis patients.   "
246096|NCT01076439|"     The purpose of this study is to evaluate the onset of action of fluticasone furoate nasal     spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic     signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after single dose     administration and six consecutive days of treatment.   "
246097|NCT01076452|"     The goal of the second phase of the study is to determine if simultaneous bilateral     subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more     effective in reducing symptoms of Parkinson's Disease.   "
246098|NCT01076465|"     The purpose of this study is to assess the efficacy of a disease management programme (DMP)     for very old patients with HF and significant co-morbidity.      METHODS: A multicenter randomized trial will be conducted with 700 patients with heart     failure, aged over 75 years, admitted to the acute-care units of the Geriatrics Departments     in 8 hospitals. Patients will be randomly allocated to a DMP or to conventional usual-care.     Randomization will be stratified by hospital and performed with concealment of the allocation     list.      The DMP will be conducted by a case manager, and will include three main components:        1. patient education to improve disease' knowledge and self-care        2. monitoring of clinical status        3. therapeutic adherence. Main statistical analyses will be performed according to the          intention-to-treat principle, and will use Cox regression models to examine the          association of a DMP with hospital readmission, quality-of-life, and mortality over 12          months.   "
246099|NCT01076478|"     To describe if there are differences in the subjective, objective and electrophysiologic     parameters of diabetic polyneuropathies at baseline, four (4) weeks, eight (8) weeks, and     twelve (12) weeks after Cilostazol therapy.   "
246100|NCT01076491|"     This study is to investigate the safety and tolerability of high doses of inhaled mannitol in     subjects with bronchiectasis to further direct development of an improved drug delivery     system.   "
246101|NCT01076504|"     This proposed trial will investigate the combination of amrubicin and carboplatin in the     first-line treatment of patients with extensive-stage small cell lung cancer (ES- SCLC).     Since myelosuppression is the most common toxicity produced by this drug combination,     pegfilgrastim will be administered with each treatment cycle. This trial will be the first     clinical trial to evaluate a combination of amrubicin and carboplatin in the first-line     treatment of ES SCLC in a U.S. population.   "
246102|NCT01076517|"     To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.   "
246103|NCT01076530|"     This phase I trial is studying the side effects and best dose of vorinostat when given     together with temozolomide in treating young patients with relapsed or refractory primary     brain tumors or spinal cord tumors. Vorinostat may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Vorinostat may help temozolomide work better by making tumor     cells more sensitive to the drug.   "
246104|NCT01076543|"     This phase I/II trial studies the side effects and the best dose of lenalidomide when given     together with temsirolimus and to see how well it works in treating patients with Hodgkin     lymphoma or non-Hodgkin lymphoma that has come back after a period of improvement or is not     responding to treatment. Biological therapies, such as lenalidomide, may stimulate the immune     system in different ways and stop cancer cells from growing. Lenalidomide may also stop the     growth of Hodgkin lymphoma or non-Hodgkin lymphoma by blocking blood flow to the cancer.     Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Giving lenalidomide together with temsirolimus may kill more cancer cells.   "
246105|NCT01076556|"     This phase I trial is studying the side effects and the best dose of alvocidib when given     together with cyclophosphamide and rituximab in treating patients with high risk B-cell     chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such     as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Alvocidib may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     rituximab, can also block cancer growth in different ways. Some block the ability of cancer     cells to grow and spread. Other find cancer cells and help kill them or carry cancer-killing     substances to them. Giving cyclophosphamide, alvocidib, and rituximab together may kill more     cancer cells.   "
247673|NCT01091467|"     The purpose of this study is to examine electrical and echocardiographic characteristics and     prognosis of consecutive patients admitted with acute heart failure and diagnosed to have     heart failure with preserved ejection fraction (HFPEF).   "
246106|NCT01076569|"     This pilot research trial studies biomarkers in bone marrow samples from pediatric patients     with high risk acute myeloid leukemia. Studying samples of bone marrow from patients with     cancer in the laboratory may help doctors identify and learn more about biomarkers related to     cancer.   "
246107|NCT01076582|"     This clinical research study will examine whether an oral contraceptive pill taken with a     monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms     compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days     after 4 cycles of treatment.   "
246108|NCT01076595|"     The aim of the SEPLUS study is to evaluate the patients characteristics associated with     adherence to Betaferon over a 24-month follow up period after the initiation of Betaferon in     the BetaPlus program   "
246109|NCT01076608|"     Cardiovascular diseases are, along with cancer, the most frequent causes for mortality and     morbidity in the industrialized nations. Numerous clinical efficient approaches to reduce the     known risk factors have been introduced in clinical routine care; yet with quite limited     success, e.g. modification of behavioral risk factors, drug treatment and the combination of     both. On the population level only marginal changes have been demonstrated, i.e. the     mortality from myocardial infarction and stroke remains high.      To answer questions about underlying factors, for this unsatisfactory status, we might profit     tremendously from studies that examine the situation, where treatment of patients most     frequently take place: in primary care. This approach pays attention to the General     Practitioner's (GP) in their gate keeping function in health care. Information from primary     care in particular is largely lacking as recently stated by the Sachverständigenrat für die     konzertierte Aktion im Gesundheitswesen in 2001. The DETECT study has been designed to     address these critical issues.      On 16th and 18th September 2003, 3,188 GPs completed a standardised assessment of the     diagnostic and therapeutic profile of 55,518 unselected consecutive patients. All patients     completed a questionnaire on their demographic data, their complaints, their illness history,     their knowledge about selected diseases and their attitude towards those. A sub sample of     7,519 patients additionally attended a standardized laboratory screening program. In this     screening the focus was on blood constituents connected with cardiovascular diseases and     diabetes, including e. g. cholesterol, lipoproteins, triglycerides and HbA1c. These patients     were assessed a second time in the follow up period after one year in 2004 and for a final     time after completion of the five-year follow-up period.   "
246110|NCT01076621|"     This study is conducted in Europe. The primary aim of this observational study is to     investigate the occurrence of bleeding in women taking 0.5 mg estradiol and 0.1 mg     norethisterone acetate (NETA) for 12 months.   "
246111|NCT01076634|"     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic     properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects     with type 1 diabetes.   "
246112|NCT01076647|"     This trial was conducted in Europe and North America. The aim of this clinical trial was to     compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with     insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or     DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with     oral anti-diabetic drugs (OADs).   "
246113|NCT01076660|"     Sudden cardiac death (SCD) poses a significant health care challenge with high annual     incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD     in patients with poor heart function. However, the critical survival benefit afforded by the     devices is accompanied by short and long-term complications and a high economic burden.     Moreover, in using current practice guidelines of reduced heart function, specifically left     ventricular ejection fraction (LVEF)≤35%, as the main determining factor for patient     selection, only a minority of patients actually benefit from ICD therapy (<25% in 5 years).     There is an essential need for more robust diagnostic approaches to SCD risk stratification.      This project examines the hypothesis that structural abnormalities of the heart itself, above     and beyond global LV dysfunction, are important predictors of SCD risk since they indicate     the presence of the abnormal tissue substrate required for the abnormal electrical circuits     and heart rhythms that actually lead to SCD. Information about the heart's structure will be     obtained from cardiac magnetic resonance imaging and used in combination with a number of     other clinical risk factors to see if certain characteristics can better predict patients at     risk for SCD.   "
246114|NCT01076673|"     The purpose of this study was to compare histologic and MRI evaluation of articular cartilage     regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling     followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without     peripheral blood stem cells (PBSC)   "
246115|NCT01076686|"     A history and physical focused on clinical sequelae of breast implant rupture was completed     by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon     shell.   "
246116|NCT01076699|"     The purpose of this study is to determine if RVX-100 is safe and effective in treating acute     abdominal pain in patients with irritable bowel syndrome accompanied by diarrhea.   "
246117|NCT01085045|"     The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of     PT003 compared with its individual components (PT001 and PT005), placebo and two active     comparators to demonstrate superiority of the combination to its components, and to assess     the relative contribution of the components compared with placebo, in patients with moderate     to very severe COPD.   "
246118|NCT01085058|"     This investigator initiated trial was a prospective, open, single-arm, diagnostic-prognostic     study. Patients who received high-dose therapy with autologous stem cell transplantation for     the treatment of their lymphoproliferative disease were included into the study.      After completion of the high-dose therapy (day -2 with respect to the stem cell     transplantation) the first blood sample A for the cytocapacity test with determination of     leukocytes and neutrophils was taken in the evening of day -1. Directly thereafter the study     medication was administered. The second blood sample B for the cytocapacity test with     determination of leukocytes and neutrophils was taken in the morning of day 0, 12-14 hours     after administration of the study medication. Thereafter the stem cell re-infusion was     performed.      The primary objective of this study was to show that the cytocapacity test with lenograstim     is a useful predictive tool with respect to the risk of post-transplant complications and     prolonged myelosuppression, typically occurring after high-dose chemotherapy.      The primary variables were:        -  the rate of patients with documented infections        -  the time to platelet engraftment   "
246906|NCT01084174|"     The purpose of this study is to explore the safety and efficacy of a sublingual (under the     tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in     inducing desensitization and long term tolerance in children with persistent peanut allergy.   "
246143|NCT01085383|"     Antipsychotic medicines are used routinely in people with severe mental illness or learning     disability. Antipsychotics often induce hyperprolactinemia (high prolactin level) and in     almost all women, and some men, this causes hypogonadism (impaired ovarian or testicular     function)often with osteoporosis, partly explaining psychiatric patients' high fracture risk.     Reducing prolactin by changing antipsychotic or adding a dopamine agonist often worsens     psychosis. Adding aripiprazole to current antipsychotic normalizes prolactin in adult     schizophrenic patients, without serious side effects. We thus plan a study of add-on     aripiprazole in people with antipsychotic induced hyperprolactinemia.      Our main hypothesis is that aripiprazole will normalize or reduce prolactin sufficiently to     restore normal ovarian and testicular function. Our secondary hypothesis is that restoration     of normal ovarian and testicular function will improve bone mineral density in patients in     whom this was reduced at the time of entry into the study.   "
246119|NCT01085071|"     Rationale: It is well known that distinctly abnormal blood potassium values can cause serious     complications such as cardiac arrhythmias. Although potassium regulation is generally     considered important, hardly any research has been done about potassium regulation in     intensive care patients. The investigators hypothesize that different potassium     target-values, within the as normal accepted range, may have different effects in critically     ill patients.      Study design: A prospective trial comparing two different potassium target-values. Potassium     will be tightly regulated with the already fully operational GRIP-II computer program.      Study population: 1200 adult patients admitted at the thoracic intensive care unit of the     University Medical Center Groningen.      Intervention: Comparison between two variations of standard therapy: potassium target-value     of 4.0 mmol/L versus 4.5 mmol/L.      Main study parameters/endpoints: The primary endpoint is the incidence of atrial fibrillation     or atrial flutter from ICU-admission to hospital discharge. Secondary endpoints are serum     levels of potassium and the other main electrolytes, renal function and renal potassium     excretion, the relation with insulin and glucose, the cumulative fluid balance, (ICU) length     of stay and mortality.   "
246120|NCT01085084|"     The study aims to evaluate the safety and clinical effect of daily oral treatment with     laquinimod capsules (0.5mg /day and 1mg /day) in active lupus arthritis patients. Laquinimod     is a novel immunomodulating drug which is currently in advanced stages of development by Teva     Pharmaceuticals Ltd. For Multiple Sclerosis.   "
246121|NCT01085097|"     The study aims to evaluate the safety and clinical effect of daily oral treatment with     laquinimod capsules in active lupus nephritis patients. This study will assess Laquinimod     doses of 0.5mg /day and 1 mg/day in combination with standard of care treatment     (mycophenolate mofetil and corticosteroids). Laquinimod is a novel immunomodulating drug     which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for     Multiple Sclerosis.   "
246122|NCT01085110|"     Describe and characterizes laparoscopic postherniotomy patients with persistent     moderate/severe pain affecting every day activities - including detailed quantitative sensory     assessment   "
246123|NCT01085123|"     The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIG®     Rapimelt (zolmitriptan) in healthy male volunteers.   "
246124|NCT01085136|"     The primary objective of this randomized, open-label, active-controlled, multi-center trial     is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with     NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone     in this patient population. Patients on both treatment arms will receive best supportive care     in addition to study treatment. Patients enrolled into the trial will be treated and followed     until death or lost to follow-up. Additional information on the health-related quality of     life (HRQOL) will be collected.   "
246125|NCT01085149|"     Simvastatin has been reported to promote osteoblastic activity and inhibit osteoclastic     activity by enhancing the expression of BMP2. There have been many studies demonstrating the     bone-promoting effect of local application various animal models including after application     into socket of teeth in a rat. the purpose of the study is to investigate the effect of slow     release topical simvastatin in socket of mandibular teeth on bone remodeling in the socket   "
246126|NCT01085162|"     This long-term study will follow patients with known or suspected of having coronary artery     disease (CAD) and have participated in present and future BMS747158 clinical studies. The     purpose of this study is to evaluate the long-term predictive value associated with BMS747158     Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI).   "
246127|NCT01085175|"     The purpose of this clinical study is to determine the optimal imaging parameters and assess     the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events.   "
246128|NCT01085188|"     Following discharge from residential treatment 324 adolescents are randomly assigned to     Assertive Continuing Care with and without motivational incentives in a 2 x 2 factorial     design. Clinical outcomes are assessed at 3, 6, 9, and 12 months post discharge.   "
246129|NCT01085201|"     Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to     change their shape from a round shape to a half-moon/crescent or sickled shape. People who     have SCD have a different type of protein that carries oxygen in their blood (hemoglobin)     then people without SCD. This different type of hemoglobin makes the red blood cells change     into a crescent shape under certain conditions. Sickle-shaped cells are a problem because     they often get stuck in blood vessels blocking the flow of blood, and cause inflammation and     injury to the important areas in the body. Lexiscan is drug that may prevent this     inflammation and injury caused by the sickle shaped cells. This drug is approved by the FDA     to be used as a fast infusion during a heart stress test in people who are unable to exercise     enough to put stress on their heart by making it beat faster. Lexiscan has never been studied     in patients with SCD and has never been given as a long infusion.   "
246130|NCT01085214|"     This phase II trial studies how well selumetinib works in treating patients with multiple     myeloma, a type of cancer in which a specific protein is over active. Selumetinib may stop     the growth of cancer cells by blocking this protein.   "
246440|NCT01089660|"     This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine     in healthy adults given a lower vaccine dose and in a similar group given a full dose of the     vaccine.      The primary objective is to describe describe the immune response of the inactivated,     split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.   "
246142|NCT01085370|"     Within a randomized controlled design the effects of a brief early psychological intervention     (child, parents) after road traffic accidents or burns shall be examined in a sample of 120     children and adolescents (aged 2 to 16 years). During the first seven days after the accident     a screening for the risk of developing a posttraumatic stress disorder is conducted to divide     the participants into a high risk and a low risk group. Participants with a low risk are     excluded from the intervention study but reassessed six months after their accident to     validate the screening instrument. After a baseline assessment within 14 days after the     accident participants of the high risk group are randomly assigned to an intervention group     (n = 60) or a control group (n = 60). The latter receive standard medical care. Children of     the intervention group are provided with a brief age appropriate two-session intervention     that includes a detailed reconstruction of the accident, psychoeducation and discussion of     helpful coping strategies. Both the control and the intervention group are reassessed by     blind raters at 3 and 6 months after the accident. Assessment of outcome includes measures of     posttraumatic stress symptoms, depression, anxiety, behavior, and health-related quality of     life.   "
246131|NCT01085227|"     Besides Parkinson's disease (PD), it exists rare parkinsonian syndromes clinically close to     PD and that correspond to Mendelian entities. Autosomal dominant forms are mainly associated     with mutations of alpha synuclein and LRRK2/dardarin genes, whereas autosomal recessive forms     are due to mutations in Parkin, Pink1 and DJ-1 genes. This entities are still unknown on the     clinical, genetic and metabolic  au plan .      Throughout a national network of 15 specialized centres in movement disorders, coordinated by     the team of the neurogenetics reference centre at the Pitié-Salpêtrière Hospital (Alexis     Brice), we propose to precise the relative frequency, the molecular bases and abnormalities     in functional neuroimaging associated with the LRRK2 gene mutations, the most frequently     implicated in the autosomal dominant forms. Due to the relative rarity of this parkinsonian     syndrome, we will perform at the same time a retrospective study in cases and families     already collected by the national network (300 isolated cases and 300 families) and a     prospective study. The network will recruit 100 isolated cases and 40 familial cases yearly,     with precise diagnosis tools. The genetic analysis will evaluate the relative frequency of     the LRRK2 mutations and their spectrum in the French population. Phenotype-genotype     correlations will be performed to better orientate the molecular diagnosis, in order to     improve the genetic counselling and reduce costs of these analyses. In the case of LRRK2     mutations, a genetic investigation will be proposed to the families, with a specific care to     at-risk cases. A detailed phenotypic evaluation of patients and at-risk cases will be     proposed (neurological, neuropsychiatric and behavioural) at the CIC Pitié-Salpêtrière and     also in imaging, for 15 patients and 40 of their relatives (20 carriers and 20 non-carriers     of the LRRK2 mutation). The TEP study will evaluate the dopaminergic function (fluorodopa     capture) and will measure the dopamine transporter (DAT). The structural MRI evaluation will     search for possible associated structural morphologic abnormalities. The functional MRI     evaluation will search for dysfunction of motor circuit during the movement realisation.     These examinations will be performed at two years of interval for appreciate the evolution of     the disease. This study will allow to better characterize the parkinsonian syndromes due to     LRRK2 mutations and also to better characterize the presymptomatic phase, which is subject to     controversies in idiopathic PD. The feasibility of this project is assured by the expertise     of the collaborative centres and by the inclusion of a retrospective cohort, combined to a     prospective cohort, which will allow to recruit sufficient patients and at-risk relatives for     a rare genetic entity.   "
246132|NCT01085240|"     The primary objective is to determine the extent to which participation in life's roles can     be optimized through the provision of a community-based structured program providing the     opportunity for physical activity, leisure, and social interaction.      A secondary objective is to estimate the extent to which participation is associated with     health benefits including health-related quality of life and reduction of unplanned     health-care encounters for the person with stroke and reduction of burden and improvement in     quality of life for caregivers.   "
246133|NCT01085253|"     To date except for the larger striato-pallidal complex, there are no reliable imaging markers     of small deep nuclei. Major improvement of the spatial resolution resulting from the use of     ultra-high field MRI systems offers new perspectives of imaging of these deep structures.      We will use the new contrast mechanisms available in data acquired with ultra-high field MR     systems (7T) as well as the most recent high angular diffusion imaging techniques in order to     characterize the cytoarchitectonics of the deep brain structures and brainstem lesions in     parkinsonian syndromes (with special interest in substantia nigra (SN) pathology and     nigro-striatal fiber pathways; subthalamic nucleus (STN), red nucleus (RN), oculomotor     structures (involved in PSP); pedonculo-pontine nucleus (involved in gait and posture control     disorders) and the locus sub-coeruleus area (implicated in sleep disorders) The optimized MR     sequences at 7T will be adapted and validated at 3T (on a more clinically oriented MRI     approach).      The clinical goal of the project (via the characterization of deep brain structures) is the     detection of new neuroimaging markers of neuronal lesions in PD. These biomarkers will be     used to create a diagnostic tool at early stage of the disease that could be correlated to     clinical signs such as gait disorders and help to identify predictive factors. In addition,     this could contribute to establish an adequate therapeutic strategy (as for example with deep     brain stimulation).   "
246134|NCT01085266|"     An open-label extension study of the HORIZON protocol evaluating the safety of dimebon     (latrepirdine)in subjects with Huntington disease.   "
246135|NCT01085279|"     The purpose of this study is to determine whether the use of non-ablative fractional laser is     safe and effective in the treatment of melasma.   "
246136|NCT01085292|"     The primary objective of this trial is to evaluate the safety and tolerability of multiple     intravenous doses of NOX-E36 in healthy subjects and patients with type 2 diabetes mellitus.     A secondary objective of the trial is to obtain exploratory estimates of the pharmacodynamic     response at the level of inflammation, metabolism as well as ongoing diabetes complications     (e.g. impaired cardiovascular, liver and renal function). Thus, the study is designed to     provide sufficient safety and dose-response data for a planned Phase IIa proof of concept     study with NOX-E36 in patients with multiple complications of type II diabetes mellitus.   "
246137|NCT01085305|"     The purpose of this study was to investigate whether a type of parent-based intervention,     Parent-Child Interaction Therapy will lower symptoms of behavior problems in young children     more than treatment as usual.   "
246138|NCT01085318|"     The purpose of this trial is to evaluate the effects of Rebif® 44 mcg subcutaneous (sc) three     times a week (tiw) on a) remyelination/demyelination, b) lesion and brain volume, c) central     nervous system (CNS) iron deposition, and d) immune status in subjects with     relapsing-remitting multiple sclerosis (RRMS) RRMS via several MRI techniques.   "
246192|NCT01086020|"     Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment     for patients with coronary artery disease. Studies indicated that coronary artery plaque     progression had positive relationship with the plasma cholesterol level, and could be halted     or reversed by intensive statin therapy (such as 20-40 mg/d atorvastatin). Ezetimibe plus     statin could further lowered blood cholesterol level. Here the investigators hypothesize that     same cholesterol lowering level by routing dose of atorvastatin or lower dose of atorvastatin     plus ezetimibe could achieve the same effect on coronary artery plaque cessation or     regression.   "
246139|NCT01085331|"     The research trial is testing the experimental treatment pimasertib (MSC1936369B) in     combination with FOLFIRI, as second-line treatment in metastatic K Ras mutated colorectal     cancer subjects. The study will be run in two parts:      Part 1, or Safety Run-in Part: Will determine the maximum tolerated dose and the recommended     Phase 2 dose (RP2D) of pimasertib combined with FOLFIRI as second-line treatment in subjects     with metastatic K Ras mutated colorectal cancer.      Part 2 or Phase 2 Randomised Part: Will assess the anti-tumor activity of pimasertib combined     with FOLFIRI compared to FOLFIRI with placebo as second-line treatment in metastatic K Ras     mutated colorectal cancer subjects.      Phase I which Is an open label dose escalation 3+3 cohort, non-randomized, safety Phase II     which is a double blind randomized safety/efficacy   "
246140|NCT01085344|"     Primary prophylaxis given less frequently initially, with the infusion frequency increased if     needed (Escalating Dose Prophylaxis), is likely to be less expensive and associated with     fewer complications than standard prophylaxis while reducing disability to a greater degree     than intermittent therapy.   "
246141|NCT01085357|"     The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for     lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.   "
246178|NCT01085838|"     The aim of this study is to evaluate the toxicity and therapeutic efficacy of erlotinib in     high-risk myelodysplastic syndrome (MDS) patients (with at least 10% of bone marrow blasts)     ineligible for or having failed intensive chemotherapy and ineligible or after failure of     treatment with a hypomethylating agent.   "
246144|NCT01085396|"     This study is designed to collect information about melanoma using a research probe, a device     placed only on the skin. This study will investigate whether using the probe to examine skin     lesions could improve the accuracy of identification pre-cancerous melanoma lesions or to     predict the risk melanoma in the skin of subjects. Ultimately, we would see this technique     used routinely as a non-invasive device during subjects' skin examination to aid     dermatologists to identify pre-cancerous (melanoma) lesions without taking tissue samples of     the skin. Alternatively, this technique would, in the future, also be used to screen patients     at risk for melanoma.   "
246145|NCT01085409|"     Aim: The aim of this proposal is to investigate the potential use and value of experienced     utility, as measured by the Experience Sampling Method and the Day Reconstruction Method, in     the economic evaluation of health care.      Methods: Three samples of 46 patients with different conditions one sample of 46 healthy     controls will be included in the study. The Experience Sampling Method (ESM) and the Day     Reconstruction Method (DRM) will be adapted and subsequently used to measure experienced     utility. Decision utilities will be elicited by traditional preference based methods.      Expected results: The expected results of this study are threefold. First, unified versions     of the ESM and DRM for use in the economic evaluation of health care will be developed and     applied. Second, a rich dataset will allow us to investigate the differences between the     results of experienced utilities derived from these methods, with the traditional preference     based measures. Third, the normative implications of the use of QALYs based on either     decision utilities, experienced utilities, or a combination of the two, for health care     resource allocation decisions, will be examined.      Keywords: experienced utility, decision utility, subjective well-being, experience sampling     method, day reconstruction method   "
246146|NCT01085422|"     Assess whether the combination of ABT-888 with temozolomide (TMZ) has activity in subjects     with metastatic castration resistant prostate cancer (CRPC) as reflected by the     prostate-specific antigen (PSA) response.   "
246147|NCT01085435|"     The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to     demonstrate the early, mid and long-term clinical effectiveness the Cameron Health S-ICD     System. In addition, analysis of resource utilization and costs will be performed to document     treatment costs for periods defined by Registry endpoints. Protocol DN 15627 (Aug 06, 2010)     restricts enrolment to patients over 18 years of age while protocol amendment DN 15677 (Aug     30, 2010) allows all patients to be included. Countries can chose their route for approval   "
246148|NCT01085448|"     The aim of this study is to determine if assessment of additional measures of trunk     neuromuscular control will improve the ability to identify patients with low back pain who     successfully respond to trunk stabilization exercises.      Question: What clinical characteristics are associated with patients that respond positively     to a program of core stabilization exercises?      Hypothesis: Clinical characteristics that show a decrease in trunk motor control will be     associated with a positive response to stabilization exercises.   "
246149|NCT01085461|"     This will be a cross-sectional study enrolling 200 outpatients/inpatients with treatment     resistant partial epilepsy for at least two years, receiving 1-3 AEDS.      The study will consist of one or two visits, each lasting 1-2 hours. All subjects will     complete Visit 1. Twenty five percent of the subjects will return for Visit 2. The study will     assess the prevalence of depression and suicidal thoughts and the feasibility of using the     proposed psychiatric rating scales in future epilepsy clinical trials. This study will also     provide an estimate of the proportion of patients with epilepsy (PWE) who may be ineligible     for future trials.   "
246150|NCT01085474|"     Measurement of disease control, treatment adherence and patient knowledge of his/her     medication in patients that are receiving a pharmaceutical intervention compared with those     patients who receive regular pharmaceutical care.   "
246151|NCT01085487|"     The aim of this prospective, non-interventional post-marketing surveillance study is to     obtain data on safety and efficacy of Mirena in treatment of heavy menstrual bleeding     (Menorrhagia) under daily-life treatment conditions.For each patient, an initial visit and     one to three follow-up visits after about 3, 6 and 12 months will be documented by the     treating physician on the case report form. Observations include the patient's demographic     parameters (date of birth, height, weight, race and smoking habits), previous contraceptives     and menorrhagia treatment, gynaecological history, baseline menstruation, result of     insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall     treatment success will be evaluated at the end of treatment including number of weeks until     improvement and reduction of menstrual bleeding with respect to duration and severity, and     patient's satisfaction.   "
246907|NCT01084187|"     The purpose of the study is to assess the correlation of FMD of brachial artery and carotid     intima media thickness with ED severity and clinical response to vardenafil in hypertensive     men.   "
246152|NCT01085500|"     Abstract: Minimally invasive techniques are now ubiquitous in the management of surgical     disease. Competence in laparoscopy requires specialized training and practice. With the     decrease of resident work hours, training programs need to explore and adopt efficient     strategies to teach and evaluate laparoscopic skills. For economic, ethical, and legal     considerations, the operating room may no longer be the ideal environment for teaching these     basic technical skills. There appears to be a role for simulation in response to this need.     The transfer of laparoscopic skills learned in a simulated environment to the operating room     has showed mixed results. Overall, it seems that surgical skills training outside the     operating room is beneficial, but the best method(s) of designing, implementing and     evaluating such skills curriculums have yet to be identified.      The laparoscopic totally extraperitoneal (TEP) inguinal hernia repair is an example of a     procedure that is associated with a steep learning curve and requires mastery of basic     laparoscopic skills. In addition, an increased recurrence and complication rates in the early     learning curve of this procedure, underscores the importance of adequate training. The     current practice of teaching the TEP repair in the operating room under an     apprenticeship-based model is associated with increased operative time and costs. We propose     that the training of surgical trainees outside the operating room with a structured, mastery     oriented simulation-based curriculum will help reduce the learning curve of the TEP repair,     improve operative performance, and decrease operative time and costs.   "
246196|NCT01086072|"     Practice in management of myocardial ischemia and infarction has changed significantly over     the past 20 years, both in terms of immediate management and secondary prevention.      The aim of this observational study is to utilize the established record linkage data     available in Tayside to investigate the trends in survivors of myocardial infarction in     Tayside since 1994.   "
246153|NCT01085513|"     Conventional intestinal manometry is the current gold standard for the evaluation of     intestinal motility, and identifies patterns of intestinal dysmotility. However intestinal     manometry involves intestinal intubation with consequent discomfort for the patients, and     requires considerable technical expertise and knowledge for interpretation of the data.     Hence, to date this method has limited indications and is restricted to very few referral     centers around the world.      A novel method for evaluation of intestinal motility has been developed based on endoluminal     image analysis using the endoscopic PillCam capsule, In contrast to manometry, this technique     is minimally invasive, the technical aspects are simple, and the analysis is fully automated     by a computer program.      The technique has been validated in a group of patients with intestinal dysmotility and     healthy subjects, and has demonstrated over 90% sensitivity and specificity.      This technique needs now to be validated in a large multinational population, to further     develop a robust discrimination algorithm for widespread diagnostic application. Furthermore,     whereas manometry only recognizes neuropathic, myopathic and obstructive motor patterns,     endoluminal image analysis may identify different categories of patients depending on the     clinical presentation and the etiologic factors involved.      This study is designed to provide evidence that the algorithm, using images created by     PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe     dysmotility.   "
246154|NCT01085526|"     The trial is randomized prospective study to examine the effects of subcutaneous     immunotherapy on the adaptive immune system. The trial includes 30 participants randomized to     treatment or control group. The effect measures are changes in the basophil activity and     biology as well as changes in plasma cells during and after treatment. Clinical outcome is     assessed by QoL questionnaires and clinical testing.      Hypotheses:        -  changes in plasma cells correlate to changes in immunoglobulins and effector cell          responses        -  the reduction of inflammation due to SCIT has influence on the effector cell responses        -  changes in paraclinical measurements can be related to clinical findings   "
246155|NCT01085539|"     Infants will be observed in the neonatal intensive care unit for 4 hours. The observer will     note the timing of oxygen saturation alarms, staff response, and interrupted staff     activities.   "
246156|NCT01085552|"     A study to see how a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy     Japanese compares with a single subcutaneous dose of Epoetin beta (NeoRecormon®) in Caucasian     Male subjects. Each subject received a single subcutaneous dose of 50IU/kg of NeoRecormon     Multidose solution on Day 1.   "
246157|NCT01085565|"     The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the     safety and effectiveness of this treatment using this ExAblate conformal system in the     treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be     recruited in this feasibility study. The treated patients will be followed for 3-Months post     their last treatment, patients with the standard contraindications to MRI examination, such     as implanted metal devices (pacemakers, etc.), will be excluded.   "
246158|NCT01085578|"     Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy     Volunteers   "
246159|NCT01085591|"     This is a randomized, double-blind, single-placebo, active-controlled, dose ranging parallel     group design with 3 arms. Two dose regimens of CB-183,315 dosed twice daily will be compared     with the active comparator oral vancomycin (125 milligrams (mg ) four times daily).     Participants with diarrhea at risk for Clostridium difficile infection (CDI) [for example,     received prior or concomitant antibiotic(s)] will be identified and tested for C. difficile     toxin in stool using an enzyme immunoassay (EIA), or polymerase chain reaction (PCR) per the     usual standard of care. Eligible participants will be consented, undergo baseline     evaluations, and will be randomized in a blinded fashion to one of 3 treatment arms.      Participants will be randomized to receive either 125 mg CB-183,315 twice daily alternating     with placebo tablets twice daily, 250 mg CB-183,315 twice daily alternating with placebo     tablets twice daily or 125 mg oral vancomycin four times dailyover a period of 10 days in a     1:1:1 fashion.   "
246160|NCT01085604|"     The purpose of this study is to determine if trunk neuromuscular control strategies are     changed by therapeutic exercises emphasizing core stabilization.      Hypothesis: subjects with low back pain who demonstrate clinically meaningful improvements in     function and pain will have significantly improved trunk motor control strategies.      Hypothesis: measures of trunk control will demonstrate 'construct-validity'. This will be     tested using a known group method demonstrating:        -  no significant change in motor control measures within the untreated, healthy control          group.        -  significant changes within the low back subjects who demonstrate clinically meaningful          improvements.   "
246161|NCT01085617|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as     rituximab, can block cancer growth in different ways. Some block the ability of cancer cells     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. It is not yet known which regimen of combination chemotherapy given     together with or without monoclonal antibodies is more effective in treating patients with     newly diagnosed acute lymphoblastic leukemia.      PURPOSE: This randomized phase III trial is studying standard chemotherapy to see how well it     works when given together with or without rituximab, and with or without nelarabine in     treating patients with newly diagnosed acute lymphoblastic leukemia.   "
246162|NCT01085630|"     RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or     observation works in treating patients with malignant pleural mesothelioma without     progressive disease after first-line chemotherapy.   "
246179|NCT01085851|"     Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema,     itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine     formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus,     including the ones caused by sunburn. The aim of the present study is to demonstrate     non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1%     lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms     and to demonstrate the safety of both preparations.   "
246163|NCT01085643|"     Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic     criteria. The pathogenesis is multifactorial and gut motor dysfunction is considered to be a     contributing factor. Changes in motor patterns in the small bowel in IBS patients are     quantitative rather than qualitative with no distinct patterns to distinguish patients from     healthy individuals. Changes in motor patterns can affect transit of bowel contents. Indeed,     variation in intestinal transit was reported in patients with IBS.      Lubiprostone is a novel agent that is Food and Drug Administration (FDA) approved for the     treatment of chronic constipation. More recently 2 randomized double-blind,     placebo-controlled trials showed the drug to be effective in relieving symptoms in patients     with constipation-predominant Irritable Bowel Syndrome (C-IBS), resulting in approval for     female patients with C-IBS at a dose of 8 micrograms twice a day.      The investigators hypothesize that lubiprostone works not just as a laxative, but by actually     altering motility patterns in the small intestine of female patients with C-IBS. These     alterations can be measured through High Resolution Manometry (HRM), a new technique that     uses catheters with multiple closely spaced sensors and special software that uses color     schemes to portray a pressure gradient. This technique allows a detailed assessment of the     direction and spread of contractions. The investigators would like to use HRM to see if     lubiprostone affects intestinal contractions by giving blinded participants lubiprostone and     placebo while they are undergoing High Resolution Manometry and seeing if any changes in     contractions occur. Participants will be recruited from investigator's clinic. If interested,     potential subjects will be provided with a copy of the consent form for review. Patients will     be informed that after they have had an opportunity to review the consent form, they may     contact the study team to further discuss the research and address any questions/concerns     they have.      Participants will undergo a screening visit and a manometry visit. During the screening visit     investigators will determine eligibility, including application of inclusion/exclusion     criteria and administration of a pregnancy test. Then during the manometry visit patients     will receive two capsules, lubiprostone and placebo, three hours apart during HRM. Patients     will receive each capsule only once and will not know which order they're receiving them in.   "
246164|NCT01085656|"     This study is intended to determine the safety and maximum tolerated dose of a drug, OXi4503     (combretastatin A1 diphosphate, CA1P, OXiGENE), in patients with relapsed and refractory AML     and MDS.   "
246165|NCT01085669|"     The study is conducted to analyse the infection rate in children treated with VEPTR-Implants     for severe spine or thoracic deformities.   "
246166|NCT01085682|"     This study was conducted to test the possibility of preventing or delaying the development of     type 2 diabetes in individuals with impaired glucose tolerance and elevated fasting plasma     glucose concentrations by internet-based diabetes prevention program.   "
246167|NCT01085695|"     The purpose of this study is to assess the pharmacokinetics of rabeprazole under fasting     condition.   "
246168|NCT01085708|"     The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial     condition.   "
246169|NCT01085721|"     Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during     viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa     more reactive to infectious agents and potentiates mucus production.      The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits     antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this     product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in     promoting mucus elimination in atopic patients with viral infections of the upper respiratory     tract.   "
246170|NCT01085734|"     Comparative study to see if treating with Osurdex in addition to Avastin in patients with     retinal vein occlusions helps increased visual acuity outcomes   "
246171|NCT01085747|"     Benign biliary strictures can be endoscopically treated with plastic or self-expandable metal     stents (SEMS). The purpose of the prospective randomized study is to compare the safety and     feasibility of covered SEMS with multiple plastic stents in the treatment of benign biliary     stricture caused by chronic pancreatitis.   "
246172|NCT01085760|"     The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and     beneficial in the treatment of Primary Sclerosing Cholangitis.   "
246173|NCT01085773|"     The objective of this randomized controlled trial was to evaluate the effects of two     different physical exercise programs aimed at long-term lifestyle changes in physical     activity in patients with Type 2 Diabetes, with glucose metabolism evaluated by HbA1c as the     primary outcome.   "
246174|NCT01085786|"     Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in     which the first component consists of a proton pump inhibitor and amoxicillin given for 7     days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be     similar with the exception that the amoxicillin will be continued throughout the 14 days. The     secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic     resistance.   "
246193|NCT01086033|"     The objectives of the study are to observe and assess the long-term use, safety and efficacy     of Humira (adalimumab), as prescribed by the rheumatologist in a normal clinical setting and     in accordance with the terms of the European marketing authorization and to observe     compliance of patients with the prescribed treatment.   "
246175|NCT01085799|"     To efficiently control soil-transmitted helminths (Ascaris, Trichuris, and hookworm), WHO,     PAHO, and others recommend the inclusion of an education strategy in school-based deworming     programs. However, the effectiveness of such a strategy on the rate of STH re-infection and     on education indicators, such as absenteeism, remains to be fully understood. The proposed     research aims to evaluate the effectiveness of a post-deworming education intervention     targeted to Grade 5 school children enrolled in Belén's schools using a cluster-randomized     trial design. Results will be used to inform school-based deworming programs in Peru and     other similar endemic areas in Latin America and, indeed, around the world.   "
246176|NCT01085812|"     The purpose of this study is to evaluate the safety and efficacy of F2695 sustained release     (SR) relative to placebo in the prevention of depression relapse in patients with major     depressive disorder (MDD).   "
246177|NCT01085825|"     With sensitive urine pregnancy tests, women are now able to confirm very early pregnancies.     However, approximately one third of abortion facilities do not offer abortions at less than     six weeks of pregnancy. Providers may be concerned that they will be unable to identify     products of conception (POCs) in uterine aspirates after early abortion and about the time,     cost and risk associated with following serum hCG levels when completed abortion cannot be     confirmed by gross inspection. Many providers believe that manual vacuum aspiration (MVA)     causes less destruction of pregnancy tissue and therefore may increase the likelihood of     identifying POCs on gross inspection. No published reports specifically compare MVA to     electric vacuum aspiration (EVA) for the detection of complete products of conception and     none compare MVA and EVA at less than 6 weeks of pregnancy. We, the investigators, propose to     conduct a randomized controlled trial comparing the sensitivity of MVA to EVA for the     detection of completed abortion in 500 women with pregnancies of less than 6 weeks gestation     at a large inner city family planning center. We will measure positive identification of POCs     on gross inspection in patients subsequently shown to have completed abortions. We     hypothesize that the rate of true positive detection of POCs will be higher in dilation and     curettage (D&C) using MVA than EVA.   "
246181|NCT01085877|"     This trial is conducted in Europe. The aim of this trial is to compare the absorption of     estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two     different production sites, in postmenopausal women with atrophic vaginitis.   "
246182|NCT01085890|"     The purpose of this study is to determine whether a program that includes 1) group seminars     and 2) follow-up visits with blood pressure measurement and motivational interviewing (MI)     that is focused on lifestyle change affect blood pressure.   "
246183|NCT01085903|"     The purpose of this study is to examine how stroke can alter arousal, alertness, neglect and     dysphagia, and whether a medication, modafinil, can improve arousal.   "
246184|NCT01085916|"     The purpose of this cross-sectional survey study is to describe the prevalence of asthma and     Rhinitis symptoms among secondary school students in Saudi Arabia.   "
246185|NCT01085929|"     The incidence of skin and soft tissue infections has increased dramatically over the last     decade, in part due to increased prevalence of community-acquired methicillin-resistant     Staphylococcus aureus (CA-MRSA). Incision and drainage (I&D) is considered the primary     intervention, however some clinicians prefer ultrasound guided needle aspiration (US Asp).     The investigators performed a randomized trial comparing US Asp to I&D for uncomplicated skin     and soft tissue abscesses, with a subgroup analysis of patients with CA-MRSA.   "
246186|NCT01085942|"     The purpose of this study is to analyze the natural course of asymptomatic rotator cuff     tears.   "
246187|NCT01085955|"     Peri-partum cardiomyopathy is a heart muscle weakness that occurs during or following     pregnancy. Research suggests that many initial heart injuries including viruses, pregnancy     and other unknown causes, can lead to a process of inflammation of the heart muscle which can     weaken the heart and cause cardiomyopathy. Why this process occurs in women during pregnancy     is not well understood and if it differs from those women who develop cardiomyopathy from a     virus is unknown. This study has been proposed to look at genetic information (DNA) as well     as the immune system (the body's response to fight off infections and/or viruses) to find     possible causes for the heart muscle damage that occurs in peripartum cardiomyopathy.   "
246188|NCT01085968|"     We are testing a computer game-style rehabilitation program for people with Parkinson's     disease (PD). People with PD often have difficulty with motor planning, such as initiating or     starting movements. We believe that our program will improve performance on a movement     initiation task as well as on activities of daily living, such as walking, preparing a meal     or opening a medicine bottle. We will measure brain function using functional MRI before and     after training to identify brain areas that are involved in improved performance. If     effective, computer based training will be an inexpensive treatment for motor planning     deficits in PD that is free from side effects and easy to administer to a large number of     patients.   "
246189|NCT01085981|"     The purpose of this study is to determine if blood flow to the clitoris is increased by     topically applying a cream that causes increased blood flow. This will be measured with a     sonogram.   "
246190|NCT01085994|"     Sepsis is common and is associated with significant mortality, morbidity and health-care     costs. Unfortunately, its diagnosis is not straightforward because its signs and symptoms are     neither specific nor sensitive; in addition, microbiological cultures lack specificity,     sensitivity and are plagued by high turn-around times. Because the delay in the institution     of antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in     ICU-patients, even when they are not needed. Procalcitonin may not be the long sought for     bio-marker to establish the diagnosis of sepsis but may help decrease the duration of the     administered antibiotic courses once they are started.   "
246191|NCT01086007|"     Previous studies have reported that about 3 % of patients who have had open inguinal     herniorrhaphy had a visceral, ejaculatory-related pain.      The investigators want to assess this problem among patients after laparoscopic inguinal     hernia repair with(self-administered questionnaire study).   "
246194|NCT01086046|"     The purpose of this study is to evaluate blood clots after Percutaneous ASD Closure in     different age, sexuality and defective diameter; evaluating the relationship of blood     clotting with Occluder, injury of intima and inflammation;comparation of the effect and     safety between different anticoagulation after Percutaneous ASD Repair; explore propose an     optimal anticoagulation plan.   "
246195|NCT01086059|"     The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and     unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic     effect of these medications and to follow live born infants for one year after birth. With     respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be     relevant to a medication exposure during pregnancy, and these include both easily     recognizable defects that are visible at birth, as well as, more subtle or delayed defects     that may not be readily identifiable without special expertise and observation beyond the     newborn period.   "
246197|NCT01086085|"     This open-label, multi-center study will evaluate the effect on the quantitative HBsAg     reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic     hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of     treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of     treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS     monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting     from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.   "
246198|NCT01086098|"     Limited data exist regarding temporal trends in permanent pacemaker (PPM) implantation. To     describe trends in incidence and comorbidities of PPM recipients, the investigators aim to     conduct a retrospective population-based cohort study using record linkage, over a 32 year     period.   "
246199|NCT01086111|"     Proof of concept, of RYGBP and its capabilities to cure type 2 diabetes (DM 2) and sleep     apnea has already been recognized in the reports on weight loss surgery.      The investigators project aims to prove that RYGBP also recovers the beta cell function (BCF)     Clamp tests, the gold standard for testing IS and BCF, will be performed preoperative and     early postoperatively.      Aims & methodology:      Analysis of the short-term effect of gastric bypass and sleeve gastrectomy on insulin     sensitivity and beta cell function.      Preoperative baseline insulin sensitivity and beta cell function will be assessed with     euglycemic and hyperglycemic clamp tests. These results will be compared with the results of     the same tests carried out 3 weeks postoperative.      To determine if the duodenal exclusion is causing this effect. The results of the clamp tests     3 weeks postoperative will be compared   "
246200|NCT01086124|"     The purpose of this study is to evaluate left ventricular systolic ejection fraction and     anterior or apical akinesis 1 month and 3 months after a myocardial infarction treated with     primary PCI to determine whether improvement at 1 month differs from improvement at 3 months.   "
246201|NCT01086137|"     The purpose of this study is to investigate the feasibility of using salivary biomarkers to     screen for complications of metabolic syndrome including prediabetes.   "
246202|NCT01086150|"     The purpose of this study is to see if an investigational drug known as the lidocaine 5%     patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how     topical lidocaine affects the nerve endings, and to determine whether treatment with the     lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in     subjects who did not report pain at the start of the study.   "
246203|NCT01086163|"     Omacor®/Lovaza® is an effective, and very safe mix of PO-3A, and the drug is currently     approved by the Federal authorities for the drug management of post-infarction patients with     high blood triglycerides. Given the growing length of CAD progression, it is pertinent that     many more patients will yield extra benefit from Lovaza® on top of aggressive antiplatelet     regimens and statin due to severity of their vascular disease. Therefore, mild antiplatelet     properties of PO-3A will be a highly desirable and attractive commodity of this medication.      The investigators believe that Omacor®/Lovaza® is ideally positioned for the chronic     management of CAD as a safe, efficient, and gentle agent with no harmful interactions with     statins or aspirin.      The investigators hypothesize that addition of Omacor may add mild antiplatelet protection     for CAD patients.      The study objectives are:        -  To assess the ex vivo effects of Omacor® on platelet function in patients with coronary          artery disease (CAD).        -  To compare ex vivo platelet-related effects after 7 and 14 days of therapy with Omacor          and statin combination versus statin alone in patients with chronic stable coronary          heart disease.        -  To establish the relation of changes in platelet activity (if any) with the lipid          profile to prove an additional benefit of Omacor® on top of statin and aspirin.   "
246204|NCT01086176|"     The purpose of this study is to see how long does the effect of a post-tetanic facilitation     last on subsequent train-of-four. The investigators hypothesis is that the effect last at     least 30 minutes.   "
246205|NCT01086189|"     Green tea consumption could lower the risk of type II diabetes, as suggested by     epidemiological studies. There is also evidence from intervention studies that green tea can     decrease blood glucose levels and contribute to weight loss.      The aim with this study is therefore to examine the postprandial effects of green tea on     glycemic index, insulin levels and satiety in healthy individuals after the consumption of a     meal.   "
246206|NCT01086202|"     The purpose of this study is to prospectively evaluate two FDA approved implant designs for     the Tornier Reverse Shoulder arthroplasty. The small difference in design is the amount of     offset each implant has. This offset may improve clinical outcomes in the patient population.     There have been no clinical comparative studies between these two designs in the literature     to date. We would like to follow these patients for two years after implantation of the     reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores.     this would be the first randomized prospective single blinded study of its kind.   "
246207|NCT01086215|"     The Registry involves the collection of information for research and educational purposes     only on the use of AngioJet in the peripheral vascular system.   "
246208|NCT01086228|"     The objectives of this post-marketing surveillance, conducted in Japan, is to know the     frequency, type and degree of device malfunction, to assure the safety of the medical device,     and to collect information on evaluation of the efficacy and safety.   "
246209|NCT01086241|"     Tomosynthesis is a new digital mammographic tool which can be performed at the same time as     routine screening mammography. It creates CT-like slices through the breast, minimizing the     tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by     increasing cancer detection rates, decreasing false negative rates and false positive rates.     This trial will help determine if tomosynthesis is useful in a screening setting.   "
246210|NCT01086254|"     Primary Objective:        -  to assess the objective response rate (ORR) of Iniparib (SAR240550) administered as a          60-min intravenous infusion twice weekly, when combined to gemcitabine/cisplatin          chemotherapy regimen (GCS) as well as with the standard regimen of gemcitabine/cisplatin          (GC) in patients with stage IV non small cell lung cancer.      Secondary objectives are:        -  to assess the safety profiles of the study combination GCS and of the standard regimen          GC;        -  to assess the progression free survival and the overall survival in both arms;        -  to assess the relationship between DNA repair pathway characteristics of tumors at          baseline and clinical outcome of disease.        -  to assess the effect of Iniparib on PAR level in peripheral blood mononuclear cells          (PBMC). (As of 10 September 2010, the collection of PBMC is temporarily discontinued.)   "
246211|NCT01086267|"     The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in     combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when     administered alone or in combination with cetuximab   "
246212|NCT01086280|"     The purpose of this study is to compare the incidence of major cardiovascular events among     patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new     initiators of oral anti-diabetic drugs (OADs)in classes other than Dipeptidyl peptidase IV     (DPP4) inhibitors.   "
246213|NCT01086293|"     The purpose of this study is to compare the incidence of hospitalization with acute liver     failure among patients with type 2 diabetes who are new users of Saxagliptin and those who     are new users of other oral antidiabetic drugs.   "
246214|NCT01086306|"     The purpose of this study is to compare the incidence of hospitalizations for infections     among patients with type 2 diabetes mellitus who are new initiators of Saxagliptin and those     who are new initiators of Oral Anti-Diabetic Drug (OADs) in classes other than DPP4     inhibitors; and to compare the incidence of hospitalizations with infections associated with     T-lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial     infections [evaluated as a composite outcome]) among patients with type 2 diabetes mellitus     who are new initiators of Saxagliptin and those who are new initiators of OADs in classes     other than DPP4 inhibitors.   "
246215|NCT01086319|"     The purpose of this study is to compare the incidence hospitalization for severe     hypersensitivity and cutaneous reactions among patients with type 2 diabetes who are new     users of saxagliptin and those who are new users of other oral antidiabetic drugs.   "
246216|NCT01086332|"     This study is designed to evaluate if nelfinavir works as a radiation sensitizer in     combination with gemcitabine (a chemotherapy). We are also looking to establish the maximum     dose of gemcitabine that is tolerated with the nelfinavir and radiation therapy, so the dose     of gemcitabine is increased based on how previous trial participants tolerated their dose of     gemcitabine.   "
246217|NCT01086345|"     RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal     tissue. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of     glioblastoma by blocking blood flow to the tumor. Drugs used in chemotherapy such as     irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving radiosurgery together with     bevacizumab and irinotecan hydrochloride may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving radiosurgery together with     bevacizumab and irinotecan hydrochloride works in treating patients with recurrent     glioblastoma.   "
246218|NCT01086358|"     Researchers want to learn about work productivity after treatment of a migraine headache with     your usual migraine medication as compared to your work productivity after treatment with     Treximet.      During this research subjects will take Treximet to treat 3 workday migraine attacks. For a     second part of the research subjects will take their usual prescribed medication for 3     workday migraine attacks. The subjects will complete questionnaires after treating each     migraine.   "
246219|NCT01086371|"     The study is being conducted to determine if a home-based walking program that uses RAS     (Rhythmic Auditory Stimulation)is a viable and effective treatment of gait instability for     people with MS.We hypothesize that an RAS-based home walking program will demonstrate     significant improvements over both regular exercise and no exercise. To test this hypothesis     we will compare between group differences from baseline and three weeks of intervention on 3     quantitative gait measures and 1 standardized MS measurement from the following 3 groups: RAS     walking, RAS no walking Other: Walking exercise The secondary goal of the study will be to     determine any carry-over effects of RAS on gait parameters in ambulatory patients with MS. We     hypothesize that RAS will produce sustained changes in gait pattern due to entrainment     processes. To test this hypothesis, we will compare gait parameters two weeks following the     cessation of the intervention with baseline and with the last week of intervention.      The third goal of this study is to determine if RAS-enhanced exercise has any transfer to     improve other areas such as upper extremity function and/or cognitive function. We     hypothesize that those participating in an RAS-based home walking program will demonstrate     improvements in other domain areas, such as cognitive and upper body functioning. To test     this hypothesis we will compare results from the Multiple Sclerosis Functional     Composite(MSFC) taken at baseline and again at the end of the treatment phase for all three     groups.   "
246220|NCT01086384|"     This study will establish the safety as well as demonstrate benefit of the addition of a LABA     to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on     both safety and efficacy.   "
246221|NCT01086397|"     The main purpose of this study is to use an investigational urine assay to estimate the     proportion of pneumonia in adults 50 years or older in different areas throughout the US that     is caused by certain types of the bacteria Streptococcus pneumoniae (also called     pneumococcus).   "
246222|NCT01086410|"     The purpose of this study is to assess the effect of six weeks' treatment with two once-daily     strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system   "
246223|NCT01086423|"     The purpose of the study is to evaluate the immunogenicity and reactogenicity of     Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4     and 5 months of age.   "
246228|NCT01086488|"     Objectives:      Primary objective      - To determine the efficacy of Foscan-PDT compared with Brachytherapy for recurrent or     persistent NPC, as determined by macroscopic clinical examination, CT scan and biopsy. The     primary endpoint is complete tumour response at 6 months.      Secondary objective:        -  To determine the response rates, e.g. presence of tumour on endoscopy, time to          progression and overall survival in patients treated with Foscan-PDT compared with          brachytherapy        -  To determine the quality of life, as derived from the University of Washington Quality          of Life questionnaire in patients treated with Foscan-PDT compared with brachytherapy        -  To evaluate the safety of Foscan-PDT compared with brachytherapy in terms of adverse          events and serious adverse events.   "
246229|NCT01086501|"     The aim of the observational study is to investigate the safety of oxcarbazepine extended     release (ER) during long-term therapy in epileptic patients. In addition, quality of life     parameters should be documented if assessed.   "
246230|NCT01086514|"     Breast tumors are normally seen with mammography or ultrasound without the use of a dye but     the size and extent of the tumor may be hard to see. Currently, after initial mammography,     many patients undergo bilateral breast MR to further stage the local tumor. It is able to not     only detect anatomic abnormalities but can also evaluate changes such as the development of     new blood vessels, which occurs with the development of cancers. MRI is extremely sensitive     and detects unsuspected disease in up to 25% of patients, which affects their treatment. It     also detects unsuspected cancer in the other breast in some patients.      However, MRI is expensive, not always available, and some patients are unable to undergo MRI     due to the presence of pacemakers, clips, or claustrophobia. Dual Energy Contrast Enhanced     Digital Mammography (DE CEDM) is an investigational procedure that uses a non-standard     contrast in a regular digital mammography exam that has been changed to give the needed dual     energy and image. DE CEDM is not FDA approved. It is our hope that DE CEDM will also be able     to detect unknown tumors because it will also detect new blood vessels. It is less expensive     than MRI, could be more available to patients, and can be done on patients with pacemakers     and clips. Claustrophobia will not be a problem. We plan to see if (DE CEDM) will help us     better see the breast tumor and size of the breast tumor. We will also want to see if DE CEDM     can detect additional unsuspected disease in the breast with the known tumor and in the other     breast without a known tumor.   "
246231|NCT01086527|"     Leukotriene receptor antagonists (LTRAs) are frequently prescribed to reduce the symptoms     associated with asthma. Singulair (montelukast), manufactured by Merck, is a popular LTRA,     however its effectiveness varies greatly between individuals. We are interested in     understanding why the effectiveness of Singulair varies so greatly.      For an oral drug such as Singulair to be effective, the body must efficiently absorb it. We     have found that blood levels of Singulair vary greatly between individuals, and we think that     this variability is responsible for variability in response.      Drug absorption occurs primarily in the intestine. Due to differences in the chemical     properties of drugs, some drugs can be absorbed easily while other drugs require help from     special proteins produced by the cells that line the intestine. These proteins, or     transporters act like revolving doors to allow drugs to move from the intestine to the     bloodstream. The activity of a transporter can be influenced by individual genetic     variability.      We think that adsorption of Singulair requires help from a transport protein called OATP2B1.     We have found that a single common genetic change in this protein is associated with low     plasma concentration of montelukast. In this proposal we will determine plasma levels of     montelukast in individuals with two copies of this genetic change. We predict that these     individuals will have roughly half the plasma level of montelukast as individuals with no     copies of this genetic change.      Eventually, what we learn from this work will allow doctors to quickly test individuals with     asthma to determine how well they will absorb Singulair and possibly other LTRAs. Knowing     this will allow the doctor to adjust the drug treatment on an individual basis to maximize     benefit in the treatment of asthma.   "
246232|NCT01086540|"     Systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH) is a serious,     life-threatening manifestation of systemic sclerosis (SSc), an autoimmune disease of the     connective tissue characterized by scarring (fibrosis) and atrophy of the skin, joints and     tendons, skeletal muscles, and internal organs, and immunological disturbances. One-year     survival for patients with SSc-PAH ranges from 50-81%. There is currently no cure for SSc-PAH     and treatment is limited to vasodilator therapy used in all forms of PAH. In recent studies,     immunotherapy was shown to be effective in treating SSc-interstitial lung disease, another     serious, life-threatening manifestation of SSc. In addition, there are compelling     pre-clinical data and anecdotal clinical reports that suggest modulation of the immune system     may be an effective strategy for treating SSc-PAH. To test this approach, this trial will     determine if rituximab, an immunotherapy, has a marked beneficial effect on clinical disease     progression, with minimal toxicity, in patients with SSc-PAH when compared to placebo.   "
246233|NCT01086553|"     This study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg     budesonide three-times daily (TID) for the induction of remission in Crohn's disease.   "
246234|NCT01086566|"     The purpose of the study is to evaluate safety and compare how the body reacts to 2 different     strengths of the Clade (specific type of H5N1 virus) 2 H5N1 flu vaccine when given as a     single vaccination with a high dose (90 mcg) or low dose (15 mcg) to volunteers who have     received at least 2 doses of the Clade 1 H5N1 vaccine, in a previous National Institute of     Health study or who have never received a H5N1 vaccine (naïve). Previously vaccinated     subjects (in studies 04-0063, 05-0090, 05-0127) will receive either 15 or 90 mcg of H5N1     vaccine. Multiply boosted volunteers who participated study 05-0043 and received Clade 1 and     3 vaccines, will receive the same dose (15mcg). Vaccine naïve subjects will receive 2 doses     of vaccine (15 or 90 mcg) separated by 28 days. Blood samples will be collected. 115     volunteers age 18-64 may participate in study related procedures for approximately 7 months.   "
246345|NCT01087684|"     Laser trabeculoplasty is a routine treatment for glaucoma and can be performed with either     argon (ALT) or selective Yag (SLT) lasers. The effectiveness of each has not been studied in     patients under 60 years, which is younger than average for the procedure. The study     hypothesis is that there will be no difference between the two laser types.   "
246235|NCT01086579|"     Prospective multicentre randomized (1:1) investigator initiated study, in which consecutive     patients undergoing percutaneous revascularization of small coronary vessels will be assigned     to one of the two study arms:        1. Treatment Arm: IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and          provisional spot bare-metal stenting (BMS).        2. Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.      Eligible subjects with coronary artery disease in a small vessel (reference diameter<2.8mm)     will be consecutively screened and enrolled based on the inclusion and exclusion criteria      The objective of the study is to assess the non-inferiority of the DEB to the PES as regards     to primary endpoint of mean late lumen loss (LLL) at 6 months, defined as the difference     between postprocedural minimum luminal (MLD) diameter and follow-up MLD, as assessed by     quantitative coronary angiography and is based on the following assumptions:        1. The means of LLL in the 2 groups are precisely equal        2. A standard deviation in LLL of 0.5mm in both groups as demonstrated in the ISAR-SMART 3          and PEPCAD II trials        3. A non-inferiority margin of 0.25mm between groups is clinically unimportant      Based on these assumptions:        1. Null hypothesis (N0): mean LLL in DEB group is ≥0.25mm than that in the PES group (i.e.          PES is superior to DEB)        2. Alternative hypothesis 1 (H1): mean LLL between DEB and PES is <0.25mm (i.e. DEB is          non-inferior to PES)        3. Alternative hypothesis 2 (H2): mean LLL between DEB and PES <0 (i.e. DEB is superior to          PES) Based on the above calculations, a sample size of 77 patients will be required in          each group to show non-inferiority of DEB vs. PES with an α error of 0.025 (one-sided Z          test) and a power of 80%. To account for a 20% rate of withdrawal, lost to follow-up or          not presenting for follow-up angiography, a total of 182 patients (91 in each group)          will be randomized.   "
246236|NCT01086592|"     The purpose of this study is to determine whether neuromuscular electrical stimulation,     strengthening exercises, or combination of both over lower limbs are effective in the     improvement of the stability fundamentally against falls, greater independence and,     therefore, better quality of life in elderly over 75 years.   "
246237|NCT01086605|"     RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells.      PURPOSE: This randomized phase II trial is studying how well pixantrone dimaleate works in     treating patients with HER2-negative metastatic breast cancer.   "
246238|NCT01086618|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy     after surgery may kill any tumor cells that remain after surgery. It is not yet known whether     chemotherapy is more effective when given alone or together with surgery in treating patients     with colorectal cancer.      PURPOSE: This randomized phase II/III trial is studying how well chemotherapy works and     compares it with surgery followed by chemotherapy in treating patients with metastatic     colorectal cancer that can not be removed by surgery.   "
246239|NCT01086631|"     Background:        -  Autoimmune retinopathy (AIR) is an inflammatory condition in which the patient s own          immune system is attacking his or her eyes and causing vision loss. Patients with AIR          are generally treated with immunosuppressive agents to treat the eye inflammation;          however, the standard treatment for this disease is still being developed.        -  Rituximab, an immunosuppressive agent, is a monoclonal antibody that is directed against          a part of the immune system that may be an important cause of AIR. Rituximab is approved          for the treatment of non-Hodgkin s lymphoma and rheumatoid arthritis, but is not          approved for the treatment of AIR. Researchers are interested in determining whether          rituximab may be used to treat AIR.      Objectives:      - To to investigate the safety, tolerability and possible efficacy of rituximab as a     treatment for AIR.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with AIR and have visual     acuity of 20/200 or better in at least one eye.      Design:        -  Before the start of the study, participants will be screened with a medical history,          immunization records, a series of eye examinations, a chest X-ray, an electrocardiogram,          and blood tests.        -  Participants will receive a maximum of two cycles of rituximab during the 18-month          study. Each cycle will involve two separate intravenous infusions of rituximab given 2          weeks apart.        -  Participants will return to the clinic 6 weeks after the first cycle of rituximab for a          safety visit, which will include a routine eye and physical examinations. They will also          provide blood and other samples for study.        -  After the safety visit, participants will return every 3 months for follow-up visits.        -  At the 6-month visit, participants who have successfully or partially responded to          rituximab will receive another cycle of treatment. Those who do not respond will not          receive another cycle, but will continue to be monitored until the end of the study.   "
246240|NCT01086657|"     Background:      - New vaccines against avian influenza, also known as bird flu, are being developed and     require testing to determine if they are safe and effective and whether they have any side     effects. Researchers are interested in testing two experimental avian influenza vaccines to     see whether they are safe, if there are any side effects from the vaccines, and how the     body's immune response differs in response to different vaccination schedules. One vaccine is     an inactivated vaccine (made with killed or weakened influenza) and one is a DNA vaccine that     allows the body to use vaccine to make an immune system response to a specific part of an     avian influenza protein.      Objectives:        -  To determine the safety and potential side effects of two experimental vaccines against          avian influenza.        -  To evaluate whether the time between the two experimental vaccine injections affects the          immune response to the vaccine.      Eligibility:      - Healthy individuals between 18 and 60 years of age.      Design:        -  Participants will be randomly divided (by chance) into six groups to receive two          injections of vaccine at different intervals. One group will receive only the          inactivated vaccine, while the other groups will receive the DNA vaccine followed by the          inactivated vaccine at different intervals (e.g., 4 weeks, 8 weeks, 12 weeks, 16 weeks          or 24 weeks later).        -  Participants will remain at the clinical center for at least 30 minutes after each          vaccination. A few days after each injection, participants will contact staff by          telephone or have a clinic visit. Participants will also be asked to complete a diary          card at home for 5 days to keep track of temperature changes, injection site skin          changes, and other effects.        -  Four weeks after the first injection, participants will return for a clinic visit and to          provide blood samples for testing.        -  Two weeks after the second injection, participants will return for a clinic visit and          provide blood samples (collected through apheresis) to provide information on immune          response to the vaccine.   "
246241|NCT01086670|"     Background:        -  Many people who have cerebral palsy (CP) have spastic diplegia, which affects the legs          and causes difficulty with leg movement and walking. Research has shown that exercise          can help those with CP learn to move their arms better, but more research is needed to          determine whether exercise programs can improve leg movements in people with CP.        -  Walking on a treadmill with the help of a physical therapist has improved the treatment          outcomes of some individuals with spinal cord injuries. Many children with CP already          have physical therapy but still have trouble with walking and leg coordination. Two          other kinds of exercise machines, a stationary bicycle and an elliptical machine, used          in the home, may be able to help children with CP walk better and move their legs          better.      Objectives:        -  To see how children with cerebral palsy (CP) move their legs differently from children          without CP.        -  To see if an exercise program can improve leg coordination in children with CP.      Eligibility:      - Children between 5 and 17 years of age who either have spastic diplegia CP or are healthy     volunteers.      Design:        -  Children who are able and willing will have magnetic resonance imaging (MRI) scans at          the start and the end of the study.        -  During Part I of the study, participants will demonstrate their leg and muscle function          with the following tests:        -  Measurement of leg size and movement        -  Combined camera motion study and electrical impulse evaluation to assess how well the          participant walks (with or without an assistive device, as needed)        -  Leg movement tests on an exercise bicycle and elliptical machine        -  Tests of leg muscle strength, stiffness, and effectiveness        -  Ultrasound scans of leg muscle        -  Parents of participants will complete computer-based questionnaires about their child s          motor abilities.        -  A smaller group of participants will continue to Part II of the study, which involves          regular exercise of 20 minutes a day, 5 days a week, for 3 months, on a stationary          bicycle or elliptical trainer. Half of the group will start this exercise program          immediately after the first part of the study, while the other half will wait 3 months          before beginning the exercise program.        -  During Part II, participants will return to the clinical center for two more sets of the          tests and evaluations performed in Part I.   "
246242|NCT01086683|"     This randomized study evaluates the effect of a multi-focused, psychosocial 6-day residential     rehabilitation course at a Danish rehabilitation centre for cancer survivors. The     investigators hypothesize that individuals in the intervention group will experience better     psychosocial well-being and more adaptive health behaviour changes as compared to individuals     in the control group.   "
246243|NCT01086696|"     Background:        -  Paclitaxel is a chemotherapy drug that is commonly used to treat different types of          cancers. However, cancer tumors can become resistant to paclitaxel, and as a result they          will fail to accumulate sufficient concentrations of paclitaxel to kill the cancer          cells. Researchers are interested in studying whether tumors have become resistant to          paclitaxel, but to do so it must be possible to see how much paclitaxel is absorbed by          the tumor cells.        -  18F-Fluoropaclitaxel (FPAC) is a form of paclitaxel that has been modified to be          slightly radioactive in order to show up on positron emission tomography (PET) scans. By          injecting a very small amount (much less that that used to treat tumors) of the          radiolabeled drug into the body, researchers hope to use PET scans to evaluate the          amount of the drug absorbed by solid tumors. Because FPAC is best used to study tumors          located above the diaphragm, all subjects in the study will have tumors near or above          the diaphragm.      Objectives:      - To determine the safety and effectiveness of FPAC as a radiological evaluation chemical.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with breast, adrenal, renal,     or lung cancer and have a tumor located someone in the body at least 1 centimeter above the     diaphragm.      Design:        -  Participants will be screened with a physical exam, blood tests, and imaging studies as          directed by the study researchers.        -  Participants will receive a single dose of FPAC, followed by a series of PET scans.          Regular scans will be performed for 3 hours after the dose of FPAC.        -  Participants will also have a single dose of a more conventional radiotracer, followed          by a series of PET scans. The results of the two sets of scans will be compared with          information from previous imaging studies of participants' tumors....   "
246244|NCT01086709|"     Background:      - National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial,     was a double-blind controlled study of the effectiveness of an experimental human     papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica.     Costa Rica was part of the first large study to show the association between HPV and cervical     cancer, and the study contributed greatly to the understanding of this association. The women     who have participated in the vaccine trial in Costa Rica are reaching the end of the     follow-up period offered in the vaccine trial protocol, and as a result they are being     offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis     B.      Objectives:        -  To offer participants in the Costa Rica Vaccine Trial the vaccine that they did not          receive during the masked portion of the trial (HPV vaccine or hepatitis A vaccine) and          hepatitis B vaccination.        -  To collect information about exposure to known and suspected risk factors for HPV          infection and cervical cancer from women who are receiving vaccination against HPV at          crossover.      Eligibility:      - Women who participated in National Cancer Institute Protocol 04-C-N191.      Design:        -  All participants will be offered vaccination against hepatitis B.        -  Women who received the hepatitis A vaccine during the trial will be offered vaccination          against HPV.        -  Women who received the HPV vaccine during the trial will be offered vaccination against          hepatitis A.        -  Appropriate vaccinations (including a combined hepatitis A and hepatitis B vaccine) will          be available to reduce the number of injections that participants will be asked to          receive.        -  All vaccines will be given according to the manufacturer's specifications for          appropriate length of time between vaccine doses.   "
246245|NCT01086722|"     Morbid obesity (MO) is associated with several disorders such as hypertension, type 2     diabetes, dyslipemia and degenerative arthropathy that require pharmacological treatment.     Drug bioavailability and metabolism in patients with MO is altered compared to population     controls. Bariatric surgery is the gold standard treatment for MO when conventional therapy     fails.      Bariatric surgery techniques can modify drug absorption in MO patients. These modifications     depend on the drug absorption characteristics and on the bariatric surgery technique used.     The changes in weight and body composition caused by BS at middle term can alter drug     bioavailability and metabolism. The kinetics of the normalization process in patients with     MO after bariatric surgery is unknown      Objectives. To analyze the changes in drug metabolism and pharmacokinetics. To establish drug     dosing criteria in the post-intervention period in patients with MO after bariatric surgery.     To determine the relationship between changes in drug bioavailability and metabolism in MO     after bariatric surgery (longitudinal gastrectomy and Y-roux gastric by-pass).   "
246246|NCT01086735|"     The main complications of allogeneic hematopoietic stem cell transplantation (HSCT) include     graft-versus-host disease (GVHD) and poor immune reconstitution leading to severe infections     and leukemia relapse. Mature donor T-cells present in the transplant facilitate T-cell     reconstitution but also induce GVHD, which itself impairs immune reconstitution. We have     developed a strategy of alloreactive T-cell depletion, using T-cells expressing the Herpes     simplex thymidine kinase (TK) suicide gene combined with a ganciclovir (GCV) treatment. This     system permits the selective elimination of dividing TK+ T-cells in vivo. To test this     hypothesis in preclinical settings, we have previously developed several experimental models     of GVHD using TK+ T-cells in mice. The demonstration that a preventive treatment with GCV     administered close to the time of HSCT could control GVHD brought the proof of concept. We     now propose a clinical trial to test whether donor lymphocytes infusion (DLI) using     TK-transduced cells permits to induce a graft-versus-tumor (GVT) effect for treatment of     relapse after HSCT, while GVHD can be controlled by GCV treatment.   "
246247|NCT01086748|"     An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill     patients with schizophrenia.   "
246248|NCT01086761|"     The purpose of this study is to assess the safety and tolerability of MP0112 (a novel,     potentially long acting VEGF inhibitor) in patients with wet Age Related Macular     Degeneration.   "
246249|NCT01086774|"     Evaluation of the optical effects of Systane Ultra   "
246250|NCT01086787|"     The investigators hypothesize that chronic heart failure is associated with a general stem     cell dysfunction, which translates into reduced paracrine function of adult stem cells from     patients with chronic heart failure as compared to patients with preserved systolic function.   "
246251|NCT01086800|"     This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.   "
246252|NCT01086813|"     Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics     and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a     Single Infusion Dose in Elderly(=65 years) Healthy Volunteers   "
246253|NCT01086826|"     This is a randomized multicenter open label phase III factorial trial evaluating the 3 years     OS in patients with locally advanced squamous cell carcinoma of head and neck treated with     locoregional treatment (radiotherapy plus concomitant chemotherapy or cetuximab) with or     without neoadjuvant chemotherapy.   "
246254|NCT01086839|"     Rhinosinusitis disorders are almost regularly associated to Cystic Fibrosis (CF). The basic     defect in CF is a dysfunction of chloride channels in exocrine glands which equally concerns     upper airway mucosa. It leads to retention of secretions and consecutive chronic inflammation     with bacterial superinfection.      In CF rhinosinusitis can restrict quality of life, give cause to repeated ear, nose, and     throat (ENT) surgery and accelerate disease progression by bacterial acquisition into the     airways.      The multicenter, randomized, double-blind, placebo-controlled, prospective clinical trial     aims at the evaluation of a sino-nasal inhalation of sodium chloride 6% compared to isotonic     saline with respect to ENT-related quality of life which is influenced by mucus retention and     the resulting inflammation.   "
246346|NCT01087697|"     The purpose of this study is to see if the Neo-Urinary Conduit(NUC), which is made in the     laboratory from a combination of a patient's own cells and other materials can be used to     form a conduit to safety allow urine flow from the kidneys to outside the body after radical     cystectomy in patients with bladder cancer.   "
246255|NCT01086852|"     To primary efficacy variable is to assess the presence or absence of excessive blood loss     during and after surgery.      The secondary efficacy endpoints are as follows:        1. A subjective overall assessment by the investigator of FACTOR X in the control of          bleeding during surgery.        2. The incidence of bleeding episodes during treatment with FACTOR X while the subject is          at risk of post-operative bleeding, including location and duration.        3. Incremental recovery of FX:C and FX:Ag after the pre-surgery bolus infusion.        4. Assessment of FX:C and FX:Ag levels on each day post-surgery.        5. Assessment of the cumulative weight-adjusted doses of FACTOR X as measured by FX:C          (IU/kg body weight) administered to each subject to maintain haemostasis.        6. Assessment of the cumulative doses of FACTOR X as measured by FX:C (IU) administered to          each subject to maintain haemostasis.        7. Amount of weight-adjusted FACTOR X as measured by FX:C (IU/kg body weight) administered          daily (day of surgery and each post-operative day) to maintain haemostasis.   "
246256|NCT01086865|"     Clinical study phase III, randomized, double-blind, prospective, comparative non-inferiority     to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC in     appetite stimulate in children, adults and elderly.   "
246257|NCT01086878|"     The purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia     or neutropenia more common in infants exposed to maternal HIV and combination antiretroviral     therapy.   "
246258|NCT01086891|"     Some oxygen conserving devices have been developed to diminish oxygen expense. These devices     offer optimisation of oxygen therapy for deambulation by improving time autonomy of patients.   "
246259|NCT01086904|"     The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted     Influenza A (H1N1) vaccine in renal transplant recipients.   "
246260|NCT01086917|"     The study is a single center, varied dose, open label study. A maximum of eighteen volunteers     will be exposed to live NF54 P. falciparum sporozoites (PfSPZ Challenge) by intradermal     injection. Volunteers will be divided into three groups of 6 volunteers, each group spaced 25     days apart (21 days after the last challenge of the last volunteer from the previous dose     group).   "
246261|NCT01086930|"     Loss of hand function is one of the most devastating consequences of tetraplegia because of     the severe impact on activities of daily living (ADL) and the resultant dependency on others.     This multi-centre study in 78 participants will measure whether additional hand therapy     provided via an electrical stimulator glove and specialised computer workstation improves     hand function in people with tetraplegia.   "
246262|NCT01086943|"     The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in     the eyelids.      Prospective, non comparative, open, monocentre study.      The objectives are:        -  To verify and establish the temperature of the eyelids and cornea for each eye before          and after 10 minutes device application        -  To evaluate the ocular surface, NIBUT and IOP before and after device application        -  To determine the acceptability of healthy volunteers on the practical use of this device      The subjects will attend 2 visits.   "
246263|NCT01086956|"     The purpose of this study is to compare metabolic and stress responses in combined     general/epidural anesthesia in geriatric cancer patients.   "
246264|NCT01086969|"     The purpose of this study is to assess the safety and immunogenicity of a single dose of     Menactra® vaccine to support registration.      Primary Objectives:        -  To describe the antibody titers measured by serum bactericidal activity using baby          rabbit complement (SBA-BR) before and after Menactra® vaccination.        -  To describe the safety profile of participants after one dose of Menactra®.   "
246265|NCT01086982|"     Check the pharmacodynamics of the drug octreotide acetate LAR 30 mg imported and distributed     by Chemical Laboratory Pharmaceutical Bergamo Ltda. compared to the drug Sandostatin LAR ®     (octreotide acetate 30 mg) manufactured by Novartis Biociências S / A, using as activity     analysis of growth hormone (GH) and growth factor insulin-like 1 (IGF-1 ) after a single dose     of the drug in patients with acromegaly   "
246266|NCT01086995|"     The purpose of this study is to determine if variability in heart and breathing rates can be     used to predict successful weaning. We are collecting data to determine whether or not subtle     differences in heart rate and respiratory function will help physicians to decide if a     patient is ready to be weaned.   "
246267|NCT01087008|"     Assessment of the antitumour effect of zoledronic acid in patients with multiple myeloma and     asymptomatic biochemical relapse      It´s proposed to investigate the use of Zoledronic acid as single therapy in patients with     Multiple Myeloma in biochemical relapse. The following must be noted:        -  Patients with no formal indication for chemotherapy treatment will be included, as          patients with symptomatic myeloma who after responding show biochemical relapse are          generally not treated. This allows for generating both a group of patients untreated, on          no additional treatment and a treatment group on zoledronic acid.        -  As these are relapsing symptomatic patients, their number is far higher than patients          with quiescent Multiple Myeloma. This allows for expecting a good enrolment.        -  There are few reliable data on symptom progression after biochemical relapse, though it          is one of the new objectives occurring in almost all clinical trials on myeloma. In the          VISTA study, it has been estimated that the median time to the new treatment is 5 months          (combining progression-free time and time to the next treatment). This time is much          shorter than the median quiescent myeloma progression-free survival, so a very long          follow-up time will not be necessary in this patient group.        -  The administration of this drug to these patients can help prevent skeleton-related          complications in the future, the study of which will be a secondary objective of this          study.   "
246268|NCT01087021|"     Primary Objective:        -  To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in          cancer patients      Secondary Objectives:        -  To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction),          and QTcN (population specific correction) intervals        -  To assess the clinical safety of cabazitaxel        -  To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during          infusion and up to 5h post end of infusion)   "
246347|NCT01087710|"     To determine the effect of medical food on reducing asthma symptoms in asthmatic children.   "
246269|NCT01087034|"     Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may     impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal     deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent     curve progression, which may affect respiratory function.      The acoustic reflection method is based on the analysis of the reflection of a single     transient planar wave giving the longitudinal cross-sectional area profile of the examined     cavity. It is noninvasive and harmless.      The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with     thoracic 3D reconstruction.      The aim of the study is to evaluate the impact of bracing on the upper airways patency (by     means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles     assessment), and on the thoracic penetration index (by means of the EOS™)   "
246270|NCT01087047|"     It is well known that airway management can be difficult during pregnancy. Increased risks     for difficult intubation in pregnant women have been often reported. Thus, pregnancy is     regarded as a period of high anesthesiologic risk.      Generalized weight gain is a well known factor influencing the upper airway in pregnant     women. However, the modifications of the airway itself are less well documented.      The acoustic reflection method is based on the analysis of the reflection of a single     transient planar wave allowing the analysis of the longitudinal cross-sectional area profile     of the examined cavity. It is a noninvasive and harmless method.      The aim of the study is to evaluate by acoustic reflection method the physiological     modifications of the upper airways during pregnancy.      Women enrolled in the study will undergo an acoustic recording during the first, second, and     third trimester of pregnancy, as well as two days and one month after delivery. Forty     pregnant women will be included in this monocentric, prospective, open labelled study.      Moreover, a single acoustic recording will be performed in 10 other pregnant women undergoing     an MRI for obstetrical purpose. The estimated caliber of the upper airways by MRI and     acoustic method will be compared.   "
246271|NCT01087060|"     The aim of this study was to show additional diagnostic criteria of computed tomography (CT)     scan to diagnose and predict the detection and recurrence of cystic renal cell carcinoma in     the patients with complicated renal cysts. Furthermore, we would demonstrate the relationship     between complicated renal cysts diagnosed by Bosniak system and some parameters of     pathological results. The analysis about detection time of renal malignancy would help     determine the practical guidelines of follow-up plan for complicated renal cysts.   "
246272|NCT01087073|"     The Improving Diabetes Care and Outcomes project aims to reduce diabetes disparities and     engages patients, providers, clinics, and community collaborators to improve the health care     and outcomes of African-Americans on the South Side of Chicago. Initiated in 2009, this     project is a collaborative, community-based intervention that employs a multifaceted,     integrated approach to address many of the root causes of health disparities. The short-term     goal of this project is to improve clinic processes such as appointment scheduling and     patient counseling through quality improvement efforts, as well as clinical outcomes     including HbA1c, cholesterol and blood pressure in patients with diabetes through patient     education. Long-term goals are to strengthen the network of community health centers,     community-based organizations and academic medical centers, while increasing awareness of     local diabetes disparities and empowering communities to combat this problem.   "
246273|NCT01087086|"     The purpose of this study is to determine whether a dietary pattern based on crononutrition     and dietary training, together with dietary and psychological control, can reduce the body     weight, improve the oxidative and inflammatory state in subjects with diagnosed metabolic     syndrome features and can reduce the prevalence of the Metabolic syndrome in the population.   "
246274|NCT01087099|"     The three major Soil-Transmitted Helminths (STH), Ascaris lumbricoides, Necator     americanus/Ancylostoma duodenal and Trichuris trichiura are among the most prevalent     parasites worldwide. The objective of this multicentre international study is to define the     efficacy of a single 400 milligram dose of albendazole (ALB) against these three STHs using a     standardised protocol. The trial will be undertaken among school age children in seven     countries - Brazil, Cameroon, Cambodia, Ethiopia, India, Tanzania (Zanzibar) and Vietnam -     each with a different epidemiologic pattern of infection. A trial of this nature is urgently     required because in spite of the wide usage of albendazole over the last 3 decades, there is     still no key publication reporting the efficacy of the anthelmintic accurately, and to modern     conventional standards, that can act as a central reference for the baseline efficacy. The     latter is critically important because albendazole is now being used even more widely, as     large scale mass treatment campaigns are being implemented in Africa and elsewhere, with the     intention of reducing morbidity in children. Such large scale usage of a drug risks     resistance developing, but resistance cannot be detected unless benchmark values for baseline     efficacy are widely known.   "
246275|NCT01087112|"     An RCT comparing mother-infant psychoanalytic treatment (MIP) with Child Health Centre care     in cases of mother-infant relationship disturbances was performed on 80 cases in Stockholm     2005-2008. The infants were < 18 months at interview #1. At 6 months follow-ups, significant     effects were shown in favour of MIP on maternal sensitivity (EAS), depression (EPDS), and     relationship qualities PIR-GAS). This study will evaluate effects at a child age of 4½ years;     to evaluate the longterm effects of MIP and CHild Health Centre care, and to better validate     results on children who now have reached an age where they can participate more actively in     evaluations.   "
246276|NCT01087125|"     The purpose of the abatacept pregnancy registry is to monitor planned and unplanned     pregnancies exposed to abatacept, to evaluate the possible teratogenic effect and to follow     live born infants for one year after birth.   "
246277|NCT01087138|"     To determine if increasing the amount of calcium that girls eat or the degree of exercise in     which they participate will increase their bone strength.   "
246278|NCT01087151|"     This Phase II, randomized, open-label, international, multicenter trial is designed to     evaluate the safety and efficacy of rituximab monotherapy when given according to a dose     intense regimen and to assess the safety, efficacy, and pharmacokinetics of ABT-263 when     combined with dose-intense rituximab in previously untreated patients with B-cell CLL.   "
246709|NCT01080885|"     The goals of this study are to evaluate the feasibility, acceptability, and potential     efficacy of an innovative obesity prevention intervention integrating pediatrician counseling     and a home-based program to prevent unhealthy weight gain among 2-4 year old children at risk     for obesity.   "
246279|NCT01087164|"     Using health behavior theories and theories related to the effects of persuasive messages     (i.e., inoculation theory), we plan to: 1. Systematically test the effects of brief     persuasive message interventions on receipt of the first dose of HPV vaccine; and 2. evaluate     the effects of the interventions on followup with subsequent doses of vaccine (using reminder     notices with persuasive message content). One set of interventions will involve a comparison     of a 1 sided message, which only emphasizes the positive aspects of a recommended behavior,     with a 2 sided message, which presents negative aspects of the behavior followed by positive     counterarguments. A second set of interventions will involve a test of a social compliance     (foot-in-the-door technique, in which half of the parent participants will be asked to     respond to a high compliance request (i.e., a request likely to generate high compliance,     such as, Do you want to protect your daughter from cancer? or for male children, Do you     want to protect your son from genital warts?before subsequently being asked about actually     having their adolescents vaccinated. The other half of the parents will not receive a high     compliance request. Parents of 11-14 year old adolescents will be randomized to the two sets     of interventions, resulting in a 2 X 2 design: message sidedness (1 sided; 2 sided) and     social compliance request (yes; no). The specific aims of this proposal are to evaluate the     1) efficacy of 2 sided vs. 1 sided messages on rates of HPV vaccination; 2) the efficacy of a     social compliance intervention on rates of HPV vaccination; and 3) potential moderators and     mediators of message effect on vaccine acceptance.   "
246280|NCT01087177|"     The study involves the testing of a Pedialink module through parent exit interviews in one     intervention practice and one control practice. Pedialink is the American Academy of     Pediatrics' online home for continuous professional development. The intervention site will     complete the Pedialink module and the control site will be given routine tobacco control     materials.      We will measure changes in practice patterns in the two pediatric practices following the     implementation of the online training. At each of these practices, the parents or guardians     of children seen by the practice will be surveyed for a one week period before, and a one     week period six weeks after either using the online training module (intervention) or being     given routine tobacco materials (control).      A follow-up telephone survey will be given to some parents at 3-months. Those given the     telephone survey are parents or guardians who smoke or parents or guardians who live with a     smoker and are surveyed at the second time-point.      We hypothesize that intervention practices will have higher rates of screening for home and     car no-smoking rules and higher rates of advising for home and car no-smoking rules.   "
246281|NCT01087190|"     It has been recommended that all transplant recipients undergo a tuberculin skin test (TST)     before transplantation. However, the ability of TST to diagnose latent tuberculosis infection     (LTBI) in transplant candidates has been reported to be suboptimal because of high rates of     false-negative and false-positive results. The enzyme-linked immunospot assay (ELISPOT)     detecting interferon-gamma secreting T-cells for diagnosing tuberculosis infection gave     promising results in immunocompromised patients as well as in immunocompetent patients. The     investigators will perform a randomized, open-label, prospective trial of isoniazid (INH)     prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients.   "
246282|NCT01087203|"     The purpose of this study is to determine the effectiveness and safety of the investigational     drug, tanezumab, in adult patients with painful diabetic peripheral neuropathy.   "
246283|NCT01087216|"     The treatment of vitiligo remains disappointing especially in some localization such as bony     prominences and extremities. The association of UVB and topical steroids has been proven to     be synergistic but the results are still insufficient in those difficult to treat areas.     Promising results have been shown with the combination of laser assisted dermabrasion,     topical 5FU and UVB. The investigators hypothesize that the dermabrasion of vitiligo skin     followed by topical steroids should potentialized the effect of UVB and be superior to     topical steroids and UVB without dermabrasion.      The main objective of this study is to evaluate the usefulness of laser assisted dermabrasion     combined to topical steroids and UVB phototherapy in difficult to treat areas.      Patients with symmetrical non segmental vitiligo will be included in this prospective     randomized monocentrer study. The investigators calculated the number of patients needed at     25. The side that will receive the dermabrasion will be centrally randomized and the opposite     side will serve as control. Then on both side class 3 topical steroids will be applied daily     3 weeks on 4 for 12 weeks. UVB phototherapy will be performed twice weekly also for 12 weeks.      The evaluation will be performed by two independent physician blinded to the treatment of     standardized photos before and 1 month after the end of the treatment. The criteria of     success will be at least 75% of repigmentation.   "
246284|NCT01087229|"     The purpose of this study is to determine whether or not the use of an equimolar mixture of     oxygen and nitrous oxide during the physical therapy for patients suffering from frozen     shoulder (adhesive shoulder capsulitis) results in a gain in shoulder amplitude (Constant     Score) and less pain as compared to patients undergoing physical therapy without this     treatment.   "
246285|NCT01087242|"     This is a randomized, doubled blind, dose-paralleled control, multi-centre clinical trail,to     evaluate the efficacy of Tang-min-ling pills in the treatment of type 2 diabetes mellitus.   "
246286|NCT01087255|"     The objective of this pilot study is to explore barriers to medication adherence among HPHC     members with CKD, particularly those not yet on dialysis, and to assess the feasibility and     acceptability of a wireless, internet-based MedMinder system intervention among HPHC     enrollees with CKD and their care partners. The investigators hypothesize that the     intervention will improve medication use and adherence among patient members with CKD on     complex medication treatment, and improve informal caregivers' ability to provide support for     improved medication use among patient members.   "
246287|NCT01087268|"     RATIONALE: Radiation therapy can cause long-term adverse effects. Hyperbaric oxygen therapy     may be effective in lessening gastrointestinal symptoms caused by radiation therapy given for     pelvic cancer. It is not yet known whether high-pressure oxygen is effective in treating     adverse effects caused by radiation therapy.      PURPOSE: This randomized phase III trial is studying hyperbaric oxygen therapy to see how     well it works in treating long-term gastrointestinal adverse effects caused by radiation     therapy in patients with pelvic cancer.   "
246288|NCT01087281|"     Background:      - Previous studies have shown that people with certain types of brain damage may have     particular problems paying attention and processing things that they see. Researchers are     interested in comparing how people with brain damage and without brain damage process visual     images.      Objectives:      - To better understand the areas of the brain involved in paying attention to things that are     seen.      Eligibility:      - Individuals at least 18 years of age who either have had damage to one or both sides of     specific parts of the brain (e.g., stroke, injury, certain neurosurgery procedures) or are     healthy volunteers.      Design:        -  The study involves 4 to 10 visits to the NIH Clinical Center over 1 to 2 years. Each          visit will last approximately 2 hours.        -  Participants will be screened with a medical history and physical examination, and may          have the cognitive testing described below during the same visit.        -  On the first visit and for at least one visit thereafter, participants will have          cognitive testing to evaluate thinking and memory. These tests will be either written          tests or computer-based tests.        -  Some participants will qualify for functional magnetic resonance imaging (fMRI) as part          of the study. This part will involve a decision-making task that will be performed on a          computer during the fMRI scan. Additional scans may be required as directed by the study          doctors.        -  Some randomly selected participants will be asked to have magnetoencephalography (MEG),          a procedure to record very small magnetic field changes produced by brain activity.        -  During the behavioral training, or fMRI or MEG scanning, participants may be monitored          with equipment to track eye movements.   "
246289|NCT01087294|"     Background:        -  Allogeneic hematopoietic stem cell transplantation (alloHSCT) is a procedure that          transplants bone marrow cells (stem cells) from a matching donor into a recipient in          order to allow the donor stem cells to produce cells that will attack the recipient s          cancer cells. AlloHSCT is performed when chemotherapy, immunotherapy, or radiation          therapy do not adequately control cancer growth. However, cancers that are not          controlled by alloHSCT frequently become resistant to other standard treatment options.        -  The outcomes of alloHSCT might be improved if certain kinds of white blood cells (T          cells) could be manipulated so that they generate a more potent effect against the          cancer cells. This effect can be augmented by genetically engineering donor T cells to          specifically recognize cancerous cells in order to attack them. For this purpose,          researchers are studying a specific kind of genetically engineered T cell known as the          anti-CD19-CAR-transduced T cell. More research is needed to determine if this T cell          will be an effective treatment for certain kinds of B cell cancer (such as non-Hodgkin s          lymphoma and chronic lymphocytic leukemia) that has not been controlled with alloHSCT.      Objectives:      - To assess the safety and effectiveness of administering allogeneic anti-CD19-CAR-transduced     T cells to patients with B-cell cancer that has not responded to alloHSCT.      Eligibility:        -  Individuals between 18 and 75 years of age who have received allogeneic hematopoietic          stem cell transplantation for a B cell cancer, but whose cancer has either not responded          to or recurred after the transplant.        -  Recipients must have the same stem cell donor from their previous procedure.      Design:        -  Before the start of the study, all participants will be screened with a medical history          and blood tests. Recipients will have tumor imaging scans, additional blood tests, and          other tests as directed by the study doctors.        -  Donor participants will undergo apheresis to provide white blood cells for researchers          to use in the treatment.        -  Recipients will have dose escalation to determine the most effective yet safe dose of          anti-CD19 T cells. There will be four dose levels of anti-CD19 T cells. The first          patients enrolled will have the smallest dose, and the dose will be increased when a          level has been determined to be safe. To reduce the risk of side effects, participants          who received a stem cell transplant from an unrelated donor will receive a lower dose of          anti-CD19 T cells than those who received a transplant from a related donor.        -  Recipients will be hospitalized for 3 days after receiving the cell infusion, and will          need to come to clinic for follow-up visits 1, 2, 3, 4, 8, and 12 weeks after the          infusion.        -  Additional scans and frequent blood tests will be required for the first 3 months after          the infusion, followed by less frequent visits over time.        -  Recipients will be followed for a maximum of 15 years after receiving the infusion.   "
246290|NCT01087307|"     Background:      - Researchers are interested in developing a registry protocol to obtain biologic and     environmental samples anonymously from adult volunteers for use in laboratory tests and     studies. The samples will be used to determine if new tests are sufficiently valid and     precise to be used in research studies and for quality control purposes.      Objectives:      - To provide a registry of samples for test development, validation, analysis, and quality     control at the National Institute of Environmental Health Sciences.      Eligibility:      - Male and nonpregnant female volunteers at least 18 years of age.      Design:        -  Samples to be collected will include blood, urine, saliva, household dust, cheek cells,          hair, nasal cells, stool, nail clippings, exhaled breath condensate, or sperm.        -  Specimens may be collected during a one-time sample collection, or participants may be          asked to provide specimens on several occasions over a specified period, not to exceed 1          year.        -  Eligible participants will be asked to come to the clinical research unit to have their          blood drawn and any noninvasive samples retrieved. Prior to blood draw, researchers will          administer a brief past 24-hour questionnaire for research purposes. Specimens will be          collected using standard clinical protocols.        -  Participants will receive monetary compensation for providing samples for this protocol.   "
246291|NCT01087320|"     Background:      - A number of rare inherited diseases affect only a few patients, and the genetic causes of     these conditions remain unknown. Researchers are studying the use of a new technology called     whole genome sequencing to learn which gene or genes cause these conditions. Understanding     the genes that cause these diseases is important to improve diagnosis and treatment of     affected patients.      Objectives:        -  To identify the genetic cause of disorders that are difficult to identify with existing          techniques.        -  To develop best practices for the medical and counseling challenges of whole genome          sequencing.      Eligibility:        -  Individuals who have one of the rare disorders under consideration in this study. These          conditions are generally those in which the genetic cause of the disorder is unknown.          The eligibility of most individual participants will be decided on a case-by-case basis          by the researchers.        -  Family members of affected individuals, if that family member (often a parent) may          provide genetic information.      Design:        -  Participants in this study will have at least one and in some cases several of the          following procedures:        -  A medical genetics evaluation.        -  Other tests that may include x-rays, magnetic resonance imaging (MRI) exams, and          consultations with other doctors. Not all studies are necessary for each person, but the          information from the tests may be required to proceed with some of our gene sequencing          studies.        -  Clinical photographs to document certain aspects of the disorder.        -  Blood and skin biopsy samples, or other tissue samples, as required by the study          doctors.        -  Genetic testing, as decided by the researchers. However, most participants in this study          can expect to undergo whole genome sequencing, which is a technique to study all of a          person s genes.        -  Some participants may be asked to take part in a telephone interview and/or a web-based          survey.        -  Participants will have choices about what kinds of results from whole genome sequencing          they wish to learn.        -  After the tests have been completed and the results of the genetic studies are known,          participants will be offered a return visit to the National Institutes of Health to          learn these results. During this visit, participants will be asked to complete surveys          and participate in interviews related to their decisions to participate in the study and          to learn individual genetic test results.   "
246348|NCT01087723|"     To show that the early administration of bivalirudin improves 30 day outcomes when compared     to the current standard of care in participants with ST segment elevation acute coronary     syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI)     management strategy, presenting either via ambulance or to centers where PCI is not     performed.   "
246354|NCT01087801|"     The following are the study hypothesis:        -  Secretin administration compared to placebo will result in a statistically significantly          greater percentage of collected fluid samples being predominantly of exocrine pancreas          origin when samples are duodenal aspirates.        -  Secretin administration compared to placebo will result in a statistically significantly          greater percentage of collected fluid samples meeting the minimum specifications for use          in the indicated laboratory test of DNA mutational analysis.   "
246292|NCT01087333|"     Background:      - Researchers who are studying hairy cell leukemia, and how the disease compares with other     disorders, are interested in obtaining additional samples from leukemia patients and healthy     volunteers. The investigators are particularly interested in samples from individuals who     have diseases that can be treated with a new type of drug called immunotoxin, in which an     antibody carrying a toxin binds to a cancer cell and allows the toxin to kill the cell.      Objectives:      - To collect a variety of clinical samples, including blood, urine, lymph samples, and other     tissues, in order to study the samples and develop new treatments for leukemia.      Eligibility:      - Individuals 18 years of age and older who have been diagnosed with leukemia or other kinds     of blood and lymphatic system cancers, or who are healthy volunteers.      Design:        -  Individuals who have leukemia will be asked to provide blood, bone marrow, urine, and          tumor tissue samples as requested by the researchers. Healthy volunteers will provide          only blood and urine samples.        -  No treatment will be given as part of this protocol.   "
246293|NCT01087346|"     Summary:        -  A few studies have explored the effects of providing parents with health information          about their children. However, more information is needed about the relationship between          awareness of health information and changes in behavior. This study will investigate the          impact of health information on choices that mothers make about food for their children.        -  Mothers with a biological child between the ages of 4-5 years old may be eligible for          this study. Participants are recruited from the Washington, DC metropolitan area.        -  In this study, before visiting the research center, participants will answer online          questionnaires about their children's health and eating habits and their own health and          eating habits.        -  At the research center, participants will use a virtual reality model of a buffet to          make food choices for their children. Participants will be introduced to the          computer-based virtual buffet scenario as a training session to prepare for using the          buffet during the experimental context. While in the virtual environment, participants          wear a video helmet that allows them to see the virtual buffet scenario.        -  After the training session, participants will watch an interactive computer presentation          about a health topic.        -  Participants will then visit the virtual buffet scenario again for the formal session,          and will choose a virtual lunch meal for their child as before.        -  At the end of their visit, participants will complete post-test questionnaires about          their experiences during the experiment and other research-related information.        -  The total time for the study is approximately 90 minutes. The participants children will          not be asked to take part in the study.      Eligibility:      - Women at least 18 years of age who have a biological child between the ages of 4 and 5 who     has no major food allergies or diet-related health conditions, developmental delays, or     disabilities. You may not take part in the study if you have a history of seizures and/or are     pregnant.   "
246294|NCT01087359|"     This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40     year. The design is based on 6 days:        -  day 1: On day time administration of LPS.        -  day 2: On night time administration of LPS.        -  day 3: On day time administration of LPS + Placebo.        -  day 4: On day time administration of LPS + melatonin.        -  day 5: On night time administration of LPS + placebo.        -  day 6: On night time administration og LPS + melatonin.      Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin     compared to placebo on the endotoxaemia.   "
246295|NCT01087372|"     This is a prospective observational study to examine the levels of glucoregulatory hormones,     with special focus on incretins levels, in critically ill patients with stress hyperglycemia.   "
246296|NCT01087385|"     Study hypothesis: elevated Troponin T is a marker of increased mortality in patients with     peripheral arterial occlusive disease (PAOD).   "
246297|NCT01087398|"     The purpose of this study is to evaluate the efficacy and side effects of donor hematopoietic     cells using chemotherapy regimen without total-body irradiation in children undergoing a     hematopoietic stem cell transplant for Malignant infantile osteopetrosis. The blood stem     cells will be derived from either related donor or unrelated umbilical cord blood or     haploidentical donor.   "
246298|NCT01087411|"     The purpose of this study is to study whether a targeted intervention can increase physical     activity in inactive 8-yr old children and how it affects secondary measures such as     metabolic- and cardiovascular risk factors and markers, self-reported quality of life, BMI,     body composition and aerobic work-capacity.   "
246299|NCT01087424|"     The purpose of the study is to evaluate efficacy and safety of R-miniCHOP for elderly     patients with diffuse large B-Cell lymphoma (DLBC) Lymphoma aged over 80 years by measuring     the overall survival.   "
246300|NCT01087437|"     BACKGROUND: Distraction osteogenesis, the gradual lengthening of bones, is performed in order     to equalize leg length discrepancy and correct skeletal deformities or to achieve greater     height in short stature people. The femur and tibia are the bones most frequently lengthened.     The surgery is currently performed at Hadassah Medical Center routinely by the pediatric     orthopedic team utilizing a variety of external fixation devices.      The procedure involves application of an external fixation device to the bone, creation of an     osteotomy and gradual, controlled distraction of the bone fragments On the last week of the     distraction phase and every month thereafter, patients will be provided with a monthly supply     of gastrolith calcium in a sealed container (65 capsules of 500 mg each, provided by     Amorphical). Starting on the first day of the last week of the distraction phase, during the     entire consolidation phase until the external fixator is removed; adults will orally consume     two (2) 500 mg capsules a day (total of 1 gr of gastrolith calcium). Children will be given     25 mg calcium per kg body weight up to the daily adult dose of 1000mg .   "
246301|NCT01087450|"     The objective of this study is to determine if observations the investigators made in an     animal model of sepsis can be translated to clinical practice. Specifically, the     investigators will use the noninvasive Orthogonal Polarization Spectral (OPS) microscope and     venous oxygen saturation to test the hypothesis that recombinant human erythropoietin(rHuEPO)     will acutely improve the microcircualtion in septic patients in the ICU.   "
246302|NCT01087463|"     The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the     Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.   "
246349|NCT01087736|"     The proposed project aims to:        1. Obtain a preliminary assessment of the efficacy of topiramate treatment in reducing          alcohol use in veterans with Post Traumatic Stress Disorder (PTSD) and alcohol          dependence;        2. Obtain preliminary assessments of safety/tolerability of topiramate in these patients;        3. Assess the feasibility of recruitment and retention for topiramate treatment in this          comorbid population; and 4) to inform the design of a planned subsequent larger          controlled trial of topiramate.      PRIMARY HYPOTHESIS: Topiramate treatment combined with Medical Management alcohol counseling     will be associated with a significant decrease in percent drinking days from baseline to end     of treatment.      SECONDARY HYPOTHESIS: There will be significantly less percent drinking days in the     topiramate treatment group compared to the placebo group.   "
246303|NCT01087476|"     Background. Mucositis is a complication of chemotherapy with no effective treatment. Aim.To     evaluate the efficacy of sub-microbial doses of doxycycline hyclate in preventing the     development of oral mucositis in patients with acute leukemia (AL) treated with induction     chemotherapy.      Hypothesis. Doxycycline hyclate administration in sub-microbial dosage will reduce the     incidence of oral mucositis in patients with AL who receive induction chemotherapy.      Methods. Double-blind, randomized, placebo-controlled clinical trial. At the Cancer National     Institute (INCan), adult patients (> 18 years of age) with acute leukemia of recent     diagnosis, scheduled to receive induction chemotherapy will be enrolled in the study. Written     informed consent from the patients will be obtained preceding inclusion in the study.      At baseline and 3-times per week, during 21-days, patients will have an oral examination     performed using the Oral Mucositis Assessment Scale (OMAS), oral pain, difficulty to swallow,     and salivary flow measurements will be recorded.      A sample size of 164 subjects has been calculated, 74 subjects in each arm of the study. The     primary end point of this study to evaluate the efficacy will be the proportion of patients     treated with doxycycline or placebo without oral lesions associated with OM, during the 21     days of follow-up. Efficacy will be evaluated if the proportion of complete response (CR) is     significantly higher than the proportion of events in the placebo group. Additional secondary     endpoints will be the partial resolution of the oral lesions, the incidence of infections and     the mortality in the study groups during the 21 days of follow-up. Results will be analyzed     by using Chi-squared test and Wilcoxon-Mann-Whitney rank sum test.   "
246304|NCT01087489|"     Patient comfort during and after eye injections will be compared after two numbing     (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4%     lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.   "
246305|NCT01087502|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or     previously treated type 2 diabetic patients with moderate to severe renal impairment and     insufficient glycaemic control. In addition safety in this patient population with longer     term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).   "
246306|NCT01087515|"     The aim of this study is to investigate the immunomodulatory potential of Isolated     Plasmacytoide Dendritic Cells (pDCs) and Regulatory T-cells (TREGs) isolated with clinical     grade magnetic bead isolations techniques (MACS®) on the antigen presenting cell-induced     proliferation of lymphocytes after allergen uptake in an in vitro cell culture system.   "
246307|NCT01073553|"     A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over     design was used with a washout of 7 days between the two study periods. Treatment groups     balanced with the same number of healthy volunteers who were randomly (in two strata: male     and female) assigned to the study drug administration sequences.   "
246308|NCT01073566|"     The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when     used in conjunction with basal insulin, achieves equivalent glycemic control when compared to     multiple daily injections and to evaluate its preference.   "
246309|NCT01073579|"     The purpose of this study is to create a patient registry to collect and analyze information     on subjects treated with Sabril and the prescribers of Sabril.   "
246310|NCT01073592|"     The Foresee Home is used in the recent years to detect age-related macular degeneration (AMD)     lesions. The device is capable of differentiation as to stages of AMD and early detection of     changes including choroidal neovascularization (CNV). The Foresee Home demonstrates a high     level of sensitivity and specificity as to the different stages of AMD including newly     diagnosed or early detection of CNV.      The OCT may be use as well to identify choroidal neovascularization (CNV). Comparison between     the two methods will allow better understanding of both devices.      The Foresee Home can use as an assessment tool for the progression and success of the     treatment given to AMD lesions. Therefore, evaluation the size and the location of the     treated lesions may serve as an additional tool.   "
246311|NCT01073605|"     To evaluate the effect of continuous and intermittent administration of Genotonorm on stature     in short prepubertal children with intra-uterine growth retardation   "
246312|NCT01073618|"     This is non-interventional study of voriconazole IV formulation in clinical use, which was     mandated by the Korean government agency following the approval of Vfend in the Republic of     Korea.   "
246313|NCT01073631|"     This is a non-interventional study of voriconazole tablet in Korea which is mandated by the     Korean government agency.   "
246314|NCT01073644|"     The primary purpose is to monitor the safety and tolerability and effectiveness of sunitinib     malate in the treatment of patients with metastatic renal cell carcinoma and gastrointestinal     stromal tumor among filipino patients in usual clinical practice setting.   "
246315|NCT01073657|"     The goal of this project is to gather data necessary for a full scale trial of a supported     education service for OIF/OEF veterans with PTSD. Forty Veterans with PTSD will be randomly     assigned to an intervention group (N=20) that receives a weekly supported education     intervention and a control group that receives services as usual plus an hour of attentive     intervention not focused on education. We will assess and compare the number of hours of     participation in community education settings and on acquiring an educational goal for the     Veterans in each group.   "
246316|NCT01073670|"     Following signed informed consent, patients scheduled for elective cardiac surgery were     randomly assigned to one of 3 groups to be given acetaminophen, Indomethacin or a combination     of both immediately following induction and then at 6, 12, 18 & 24 hours following surgery.     Our primary outcome measure was the amount of blood drained from the mediastinal tubes and     chest drains. Secondary outcome measures included conventional blood coagulation indices as     well as other measures of clotting as indicated by thromboelastography (TEG). Other secondary     outcome measures included consumption of morphine equivalents and pain scores.   "
246350|NCT01087749|"     The purpose of this study is to find out how chemicals in the blood of patients with chronic     kidney disease affect how medications are removed from the body. The patient will take one     dose of three different drugs, one on each week, for a total of three single doses. The     investigators want to find out if these three different medications are affected in different     ways by the chemicals in the blood of patients with kidney disease.   "
246317|NCT01073683|"     Treatment of patients with one cycle of induction chemotherapy to select for organ     preservation of the larynx has been proven as a standard approach. When compared to     historical controls. The investigators propose to study patients with a similar treatment     strategy (i.e. one cycle of induction chemotherapy followed by two more chemotherapy cycles,     in advanced nodal disease, followed by chemoradiation for those responding to the initial     chemotherapy. Those who fail to respond or fail in radiation will directly undergo surgery.     The novelty of the proposed study is that non responders and failures will be given the     opportunity of larynx preserving supracricoid laryngectomy. The investigators will attempt to     reduce toxicity from induction chemotherapy and improve potency with the use of     docetaxel/cisplatin/5-fluorouracil (TPF) in place of the standard regimen of cisplatin and     5-fluorouracil (PF). Emerging data demonstrates that induction regimens containing triplets     with platinum, 5-fluorouracil, and taxanes produce higher response rates and less overall     toxicity when compared to induction strategies utilizing PF   "
246318|NCT01073696|"     The purpose of this study is to determine the effect of heat applied to a granisetron     transdermal patch in healthy subjects.   "
246319|NCT01073709|"     The study was conducted as an open labeled, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover, bioavailability study comparing acetaminophen extended     release gelcaps 650 mg of OHM Laboratories Inc. with Tylenol® Arthritis Pain caplets 650 mg     of McNeil Consumer & Specialty Pharmaceuticals, in healthy, adult, human, male subjects under     fasting condition.   "
246320|NCT01073722|"     Lung isolation is used to achieve one lung ventilation to facilitate thoracic surgery. Two     methods are commonly used, a double lumen tube (DLT) or a bronchial blocker introduced     through a single lumen tube. However, both techniques have advantages and disadvantages.     Briefly, the DLT can be positioned faster and remains firmly in place, but is sometimes     difficult or even impossible to introduce. The DLT is larger than a conventional single lumen     tube and the incidence of postoperative hoarseness and airway injuries is higher. Compared to     the DLT, bronchial blocking devices are more difficult to position and need more frequent     intraoperative repositioning. These disadvantages of the existing devices for lung isolation     prompted further development of the bronchial blocker concept. The design of a new Y shaped     bronchial blocker, the EZ- Blocker® (AnaesthetIQ BV, Rotterdam, The Netherlands) (EZB),     combines the advantages of both lung isolation techniques. The aim of the study is to compare     in a randomised, prospective way the ease of placement, the incidence of malpositioning and     the quality of lung deflation of a left DLT and a EZB. Secondly, the incidence and severity     of damage to laryngeal, tracheal and bronchial structures caused by the use of the DLT or the     EZB is a target of the study.   "
246321|NCT01073735|"     This feasibility study will determine the psychometric adequacy of a newly developed     instrument - Childhood Cancer Survivor Study Needs Assessment Questionnaire (CCSS-NAQ).     Additionally, the study will explore the feasibility of selected study methods -- sample     selection, length of time to complete recruitment, and response rates - in order to inform a     larger national periodic survey of adult survivors' health related needs   "
246322|NCT01073748|"     Asthma is a common inflammatory airway disease. Several researches have demonstrated a     possible connection between asthma and exposure to paracetamol.      Our hypothesis is that even a single dose of paracetamol is sufficient to cause a measurable     change in lung functions.      This trial aims to identify a possible effect of single dose paracetamol on lower airway     function.   "
246323|NCT01073761|"     The purpose of the study is to look at the levels of three HIV medications darunavir,     ritonavir and atazanavir in the blood after the drug intake has been stopped in order to     understand how long these drugs persist in blood for. The study will specifically look at     these three drugs blood levels after taking them for 10 days everyday.      The main objective is to provide information on the potential safety (in terms of preventing     virological failure and the development of resistance)of delaying drug doses occasionally by     providing information on the decline in drug concentration after dosing has stopped.   "
246324|NCT01073774|"     The diagnosis and treatment of cancer leads to emotional distress, and major disruptions in     role functioning. Traditionally, psychosocial services offer individuals diagnosed with     cancer peer group support or individual counseling with only few consideration of type or     stage of cancer. Besides most cancers significantly impacting not only the individual but     also their partners and families, breast and gynecological cancer may be particularly     embedded in an interpersonal context, namely in the couple's relationship. Breast and     gynecological cancer cause additional concerns about the women' body image, sexual     functioning and these cancers may be prone to provoke or enhance maladaptive patterns of     interaction between women and their partners. Thus, not only the individual but also the     couple's functioning is threatened by these diagnoses.      The aim of the here proposed study is to identify predictors of couple's adjustment and to     help couples to improve their ability to support each other during this time. In a multi-site     study, we will evaluate the efficacy of a couple-based intervention entitled Side by Side:     Coping with Cancer Together (Seite an Seite: Krebs Gemeinsam Bewältigen). The intervention     teaches couples relationship skills that have been repeatedly validated within the marital     field. The aim of the intervention is to improve couples' skills to talk to each other     effectively about cancer-related topics, and enhance (or maintain) an affectionate     relationship in the face of death.      We will randomly assign 303 women recently diagnosed with either breast or gynecological     cancer and their partners to one of two conditions: (1) Seite an Seite, or (2)     Treatment-As-Usual, in which couples receive no active psychosocial intervention. Assessment     will be conducted pre-, post-, and at 6 and 12 months follow-up. These assessments include     for both partners negative and positive self-report measures of individual functioning (such     as mood, anxiety and benefit finding) and relationship functioning (such as relationship     distress, communication patterns). Furthermore, at pre-, post- and 12-month Follow-up     observational data on mutual supportive behavior when communicating about a cancer-related     topic will be collected. The study may enhance our understanding of the significance of     relationship skills in the process of adjusting to cancer as a couple and as an individual.   "
246325|NCT01073787|"     The purpose of this study is to evaluate the effect of intravenous fluid (0.9% sodium     chloride and water) alone on headache pain in children with migraine visiting the Emergency     Department.   "
246351|NCT01087762|"     The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to     evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects     with active axial Spondyloarthritis (axial SpA).   "
246355|NCT01087814|"     We are studying if putting a gel capsule over a standard HIV drug changes the ability of the     body to absorb the drug. This is important because we want to be able to study new HIV drugs     against the most common drugs used today and the most common is Sustiva, which is also called     efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is     absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will     draw blood to see how much is absorbed.   "
246326|NCT01073800|"     Patients are admitted to the critical care unit of the hospital because of medical conditions     that have a high likelihood of causing severe problems with blood flow, breathing, or brain     function. These conditions also have a high likelihood of causing death. Approximately 10 to     15% of all critically ill patients die in hospital. A large amount of scientific evidence     suggests that a substantial proportion of these deaths is due to a combination of blot     clotting and inflammation in the blood vessels.      Statins are drugs that interfere with cholesterol and fat metabolism. Cholesterol and fat in     the blood are associated with blood clotting and inflammation in the blood vessels. Statins     are known to be very beneficial in improving the survival after heart attacks, and in     preventing heart attacks.      The question that VASTVALUS asks is: do statins improve survival among all critically ill     patients? In VASTVALUS, we will concentrate on patients that do not currently require a     statin because of their medical condition e.g. after a heart attack, but we are concerned     with the rest of the critically ill. In VASTVALUS, participating patients will receive either     atorvastatin 80 mg daily or a placebo. Atorvastatin is a statin with a well-established     record of safety and effectiveness. A placebo has no known medical activity. We will follow     all patients in VASTVALUS to determine whether atorvastatin has any effect on the occurrence     of death, stroke, heart attack, or kidney failure among the critically ill. Results from     VASTVALUS will be shared with the medical community after the study is completed. As with all     clinical trials, patients in VASTVALUS participate of their own choice, and can change their     mind at any time.   "
246327|NCT01073813|"     The primary aim of this open-label pilot trial is to estimate the treatment effect of 100 mg     of oral minocycline twice daily for 90 days, initiated within 30 days of onset of ON, on     functional and structural optic nerve recovery compared to no treatment. The primary outcome     measure that will be used to measure optic nerve recovery is retinal nerve fibre layer (RNFL)     thickness. Other objectives: Secondary outcomes are temporal RNFL thickness, macular volume,     and visual outcomes.   "
246328|NCT01073826|"     The purpose of the study is to understand the role of interleukin-6 during physical activity     in patients with type 2 diabetes.   "
246329|NCT01073839|"     OBJECTIVES      Primary objective:      The primary objective of the trial is to determine the safety of adjuvant treatment with     cisplatin plus gemcitabine for a period of 6 months after curative resection of     cholangiocellular carcinoma      Secondary objectives:      Secondary objectives of the trial are to assess the feasibility and efficacy of the adjuvant     therapy and to determine duration of response and patterns of failure compared to historical     controls without postoperative treatment      Exploratory objectives:      To obtain blood samples and tumor tissue after resection for establishment and     characterization of new cholangiocarcinoma cell lines and tumor antigens. Other aims are     identification of tumor specific antibodies from blood samples, and characterization of tumor     antigens with consecutive development of new specific immunological therapies, e.g.     cancer-testis antigens (CTA) for tumor vaccination.        -  Trial with medicinal product   "
246330|NCT01073852|"     This study is for those people with difficult to treat hives. We are investigating whether or     not a different medication, hydroxychloroquine, works to treat a certain type of hives.     Hydrochloroquine is currently approved by the Food and Drug Administration (FDA), for     treating arthritis, therefore it is considered investigational in this study.      Hypothesis: Hydroxychloroquine will prove to have an efficacious response in terms of     Urticarial Symptoms, on patients with chronic urticaria.   "
246331|NCT01073865|"     The purpose of this study is to examine the efficacy and safety as well as the     characteristics of the female hormone and study medications after administration in     pre-menopausal women with advanced or recurrent breast cancer who were randomised in a 1:1     ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg     depot group, both given in combination with tamoxifen tablets.   "
246332|NCT01073878|"     The purpose of this study is to determine if the Athena Pelvic Muscle Trainer device     effectively treats stress, urge or mixed incontinence in women by strengthening the pelvic     floor muscles by collecting data from the patient on the        1. Over Active Bladder Questionnaire        2. The 7-Day Urine Diary questionnaire           This study will also look at whether or not there is an improvement in sexual health          after using the device by collecting data frm the patient on the        3. Female Sexual Function Index questionnaire   "
246333|NCT01073891|"     The purpose of this study is to describe the pharmacokinetics of a new oral liquid     moxifloxacin formulation and the influence of concommitant food intake on the     pharmacokinetics in healthy adults compared to the marketed oral tablet. Pharmacokinetics is     to see how the body absorbs, distributes and gets rid of the study drug. The absorption of     the drug administered in a different dosage form may be altered due to the influence of     different excipients used. The safety of moxifloxacin when administered as an oral liquid     formulation will also be looked at. Results from this study will be used to guide dosing     strategies of the larger clinical trial planned for children.   "
246334|NCT01087528|"     To evaluate the performance of PillCam COLON 2 in regards to detection of patients with     polyps where colonoscopy is considered as the gold standard reference.   "
246352|NCT01087775|"     The investigators hypothesis are as follows:      H1a: OEF/OIF veterans with PTSD who perform cognitive training (CT) will demonstrate greater     objective improvements on standard (untrained) neurocognitive measures, with the largest     gains in verbal memory, learning and sustained attention.      H1b: Objective cognitive improvements in CT participants will be sustained at three months     post-intervention, suggesting persistence of neuroplasticity-based cognitive training     benefits.      H2a: OEF/OIF veterans with PTSD who perform CT will report greater improvements in cognitive     function.      H2b: OEF/OIF veterans with PTSD who perform CT will demonstrate improved social and     occupational functioning and quality of life.      H2c: OEF/OIF veterans with PTSD who perform CT will demonstrate greater improvements in     community reintegration.   "
246353|NCT01087788|"     Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to     evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset     active and progressive Psoriatic Arthritis (PsA).   "
246382|NCT01088906|"     This is a study of pemetrexed disodium plus cisplatin as first-line therapy in patients with     advanced non-squamous cell lung cancer. This is a phase IIA pharmacogenomic trial.   "
246335|NCT01087541|"     The safety in the diabetic patient refer so much to the accuracy of the treatment and to the     handling of the diabetic in security topics. Therefore, is not only an economic question, but     a more global concept that means to receive an accurate sanitary attention in line with the     available evidences nowadays.      OBJECTIVE: To analyse if a brief intervention educative on the primary care professionals is     followed of an improvement in the safety of the diabetic patients.      METHODS: Cluster Clinical trial, completely in primary care, on 10 basic health areas (BHA)     with a random distribution of the educative intervention to realize on the sanitary     professionals (5 intervention/5 control). The intervention is an educative system on adults,     brief (6 hours) but with periodic reminders. To improve his skills and attitudes for the     diabetics. The group control follows his usual clinical practice on the diabetics.      The participation was voluntary. The centres have been matched, being comparable in     population and other characteristics, except the specific intervention; ranging between the     6-8% the prevalence observed of type 2 diabetes (T2D) in all the cases. Finally, we selected     only between 45 until 75 years old as operative age group of the 45 until the 75 years like     operative aim.      Inclusion criteria: T2D or T1D with age comprised between 45 and 75 years; recorded in the     informatic software for primary care.      Exclusion criteria: serious or terminal illness or patients controlled exclusively by     specialists.   "
246336|NCT01087554|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination vorinostat given in combination with either sirolimus, everolimus or temsirolimus     that can be given to patients with advanced cancer. The safety of this drug combination will     also be studied.   "
246337|NCT01087567|"     T2DM has become an American Epidemic. Currently 8% of the US population has diabetes and     rates may be as high as 33% by the year 2050 (1). Although there are many treatment options     for people with T2DM, none have been proven in humans to prevent the defects in insulin     secretion (2) and insulin action (3) and beta cell dysfunction (4) that result with very high     glucose levels and typically worsen as the disease progresses. Any treatment that could delay     the progression of pancreatic beta cell failure (as measured by the need for rescue therapy     with oral agents) would be a significant advancement in diabetes treatment.      Insulin therapy is appropriate at any point in T2DM disease progression, but it is commonly     only used as a rescue therapy after failure of oral therapies. A number of outpatient insulin     titration protocols have been shown to be safe and effective and speed patient's ability to     gain glucose control (5-8). Recent studies have shown that initiation of insulin at onset of     T2DM is beneficial at achieving early and long-term glucose control (6-9). However these     protocols have used intravenous human insulin in the in-patient setting, continuous     subcutaneous insulin by insulin pump or older human insulins in the out-patient setting. Many     of these protocols are unlikely to be utilized in routine patient care. To date, no insulin     first studies have been published with analog insulins in an outpatient basal-bolus regimen     with patient driven titration.   "
246338|NCT01087580|"     The main purpose of this study is to find out whether adding radiation therapy to the     standard treatment of chemotherapy for prostate cancer is tolerated well and is more     effective than the standard treatment of chemotherapy alone   "
246339|NCT01087593|"     In order to evaluate the potential effects of estrogen treatment in postmenopausal women with     fibromyalgia, the investigators used quantitative sensory tests before and after eight weeks     of estrogen treatment as compared with placebo treatment.   "
246340|NCT01087619|"     General consensus and contemporary guidelines, recommend surgery for primary     hyperparathyroidism (pHPT)for all patients below the age of 50, for patients with pronounced     hypercalcemia and for patients with organ complications to the disease (osteoporosis and     decreased renal function).      The purpose of this study is to determine if surgery for pHPT, is appropriate for patients     with mild hypercalcemia older than 65 years of age.      The hypothesis of the study is that surgery for pHPT in patients older than 65 years of age,     and with mild hypercalcemia, will increase bone density and hence decrease future risk for     fragility fractures compared to patients with follow-up only.   "
246341|NCT01087632|"     Metabolic syndrome is a highly prevalent condition characterized by visceral obesity,     abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events.     Such findings appear to be associated with a decrease in insulin sensitivity. Management of     metabolic syndrome is currently aimed at treating individual components of the disease     without addressing this underlying pathophysiologic mechanism; this translates into multidrug     regimens, high costs and patient compliance issues.      Armolipid Plus (an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin     K,policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg) has been found to     be effective at reducing blood cholesterol and triglycerides, and at improving endothelial     function; subgroup analyses also suggested a benefit on indices of insulin resistance.      Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity and on     the diagnostic parameters of metabolic syndrome.      60 patients will be enrolled in this randomized, double-blind, placebo-controlled trial;     active treatment will consist of Armolipid Plus (1 tbl qd).      Primary end point will be the reduction of the insulin/glucose ratio, both after overnight     fast (HOMA index) and after an oral glucose tolerance test (OGTT).   "
246342|NCT01087645|"     This trial is conducted in Europe. The aim of this trial is to investigate the safety,     tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy     male subjects.   "
246343|NCT01087658|"     Primary Objective:      To assess the benefit of glutamine when added to calcium-magnesium on the occurrence of grade     2, 3 and 4 peripheral sensory neuropathy (PSN) related to oxaliplatin with the National     Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) scale taking into     account the time from start of oxaliplatin at which the first event occurred.      Secondary Objective:      To determine cumulative dose of oxaliplatin and time when the first occurrence of grade 2, 3     or 4 PSN.      To determine the incidence of dose-reductions, dose-delays and discontinuations of     oxaliplatin due to PSN grade 3 or 4.      To assess effects of glutamine when added to calcium-magnesium on patients-reported outcomes     using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12     items questionnaire (FACT/GOG NTX-12) subscale.      To evaluate the incidence of diarrhea. To determine Progression Free Survival (PFS) in     metastatic patients.   "
246356|NCT01087827|"     The first purpose of this study is to see how blood pressures taken at different sites,     specifically the forearm, upper arm and heart vessels, are different. The second purpose is     to see if body structures such as vessel size and depth, size of the arm, and amount of     tissue in the arm influence differences in blood pressures taken at these sites. The third     purpose is to develop a mathematical model of the waves generated by the arm arteries     (brachial and radial) to predict differences in forearm and upper arm blood pressures. The     results of the study may be used to design more accurate non-invasive blood pressure monitors     for the forearm site.   "
246357|NCT01087840|"     The use of anti-HIV drugs following a potential sexual or injecting drug use exposure to HIV     in order to try and prevent an exposure from becoming an infection is common. This is called     nonoccupational postexposure prophylaxis (NPEP). The likelihood of NPEP succeeding is related     to intrinsic qualities of the drugs used which includes at which point in the life cycle of     the HIV virus the drugs work, how strong the drugs are against HIV, and how well tolerated     the drugs are i.e. what side effects they produce. Many people skip doses during their     treatment or abandon their treatment because of side effects. The anti-HIV drug raltegravir     works early in the life cycle of the virus i.e. before it integrates with human DNA, is     potent against HIV and causes few side effects. These qualities make it an obvious choice for     use as a NPEP treatment. In this study 100 HIV negative men will receive raltegravir along     with another HIV drug called truvada (commonly used in NPEP) for 28 days after a possible     sexual exposure to HIV. They will be monitored closely for adverse events, side effects and     for their ability to take the medicine each day for the whole 28 days. The hypothesis in this     study states that raltegravir use in NPEP will be safe, well tolerated and result in a high     treatment completion rate.   "
246358|NCT01087853|"     Patients often require fluid replacement during and after an operation. This is usually given     through veins in the arm using an intravenous cannula and doctors have traditionally used     fluid containing sodium chloride (saline). However accumulating evidence suggests that large     infusions of saline are associated with adverse physiological effects including acidification     of the blood and a rise in potassium and chloride levels. Studies in animals have shown that     high levels of chloride in the blood and excess saline can cause blood vessels in the kidney     to constrict leading possibly to a decrease in kidney function. Improvement in acid-base     balance and kidney function may be observed with balanced solutions containing constituents     that are more closely matched to the body's own fluid composition. However, little is known     about the physiological effects of these solutions as they have only recently been developed.      Magnetic resonance imaging (MRI) is a radiological modality which can now assess blood flow     and supply of the kidney noninvasively without the need for the injection of radiological     dyes known as contrast agents. This is now of major importance due to the possible adverse     effects of MRI contrast agents leading to Nephrogenic Systemic Fibrosis (NSF), a progressive     disease which has been observed in some kidney patients after receiving 'gadolinium based'     contrast agents. This has therefore led to increased interest and demand for noncontrast     based imaging methods. In this study we aim to compare the effects of balanced versus     unbalanced fluid infusions in healthy human volunteers:      We will aim to measure:        1. Blood biochemical composition and acidity        2. Kidney function and supply as measured by dynamic MRI   "
246359|NCT01087866|"     The purpose of this study is to determine if metformin therapy prevents fetal macrosomy in     gestational diabetes mellitus to the same extent as insulin therapy.   "
246360|NCT01088620|"     The purpose of this trial is to estimate the therapeutic efficacy of the experimental     targeted regimen including the EGFR antibody panitumumab (in combination with pemetrexed and     cisplatin) in relation to the standard combination in patients with a KRAS wild-type stage     IIIB or IV primary nonsquamous non-small cell lung cancer. It is expected that the     progression free survival rate at 6 months is improved by the targeted regimen.   "
246361|NCT01088633|"     This study is aiming at evaluating the characteristics of particle emission in subjects with     different stages of chronic obstructive pulmonary disease (COPD) compared with healthy     smokers.   "
246362|NCT01088646|"     The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic     capsule placement Capsule Endoscopy Delivery System.   "
246363|NCT01088659|"     This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated     interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic     hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180     micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily).     Anticipated time on study treatment is 2+ years, target sample size is <50.   "
246364|NCT01088672|"     To determine the revascularization rate of the CE-marked Trevo device in large vessel     occlusions in ischemic stroke patients.        -  Revascularization, defined as at least TICI 2a in the vascular territory treated at end          of the neuro interventional procedure.   "
246365|NCT01088685|"     Study to evaluate the safety and performance of a new blister patch intended to treat     blisters on the heel of the foot.   "
246366|NCT01088698|"     Golimumab, a TNF-alpha antibody, has been approved in the EC and USA for the treatment of     psoriatic arthritis. The aim of this study is to determine in a randomized half-side     comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the     clearance of psoriatic skin lesions in golimumab-treated patients.   "
246367|NCT01088711|"     This study will test the safety and tolerability of omarigliptin. It is hypothesized that     administration of once-weekly omarigliptin in obese but otherwise healthy participants, and     in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated     to permit continued clinical investigation.   "
246368|NCT01088724|"     Fludarabine may be of benefit to prevent rejection of grafted solid organs in children during     chemo-immunotherapy treatment for post transplant lymphoproliferative diseases (PTLDs).   "
246383|NCT01088919|"     The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics and safety     following the administration of ASP1941 and pioglitazone hydrochloride in multiple and single     doses.   "
246384|NCT01088932|"     This is a multiple dose clinical study to be conducted with SRX246 capsules to determine the     safety, tolerability and pharmacokinetics of the drug over a 14 day dosing period.   "
246369|NCT01088737|"     This is a prospective, longitudinal, uncontrolled study with follow-up for 5 years.Patients     having undergone surgical excision of lentigo maligna (LM) or lentigo maligna melanoma (LMM)     will be invited to this study. Eligible patients will start treatment with imiquimod 6 weeks     after the excision, the treatment will last for up to 12 weeks. Inflammatory reactions and     the occurrence of residual lesions will be documented. The healing effect will be determined     (initial clearance rate) 20 weeks after start of treatment with imiquimod. All patients who     were enrolled (=exposed to imiquimod in this study) will be followed up for 5 years or until     recurrence of the LM or LMM   "
246370|NCT01088750|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, vinblastine, and     prednisolone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Surgery to remove involved lymph nodes may be an     effective treatment for young patients with nodular lymphocyte-predominant Hodgkin lymphoma.      PURPOSE: This phase IV trial is continuing to study the side effects of giving surgery alone     or giving surgery with cyclophosphamide, vinblastine, and prednisolone compared with giving     cyclophosphamide, vinblastine, and prednisolone alone in treating young patients with stage     IA or stage IIA nodular lymphocyte-predominant Hodgkin lymphoma.   "
246371|NCT01088763|"     This phase I/II clinical trial is studying the side effects and best dose of gamma-secretase     inhibitor RO4929097 and to see how well it works in treating young patients with relapsed or     refractory solid tumors, CNS tumors, lymphoma, or T-cell leukemia. Gamma-secretase inhibitor     RO4929097 may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth.   "
246372|NCT01088776|"     Children with Chronic Kidney Disease (CKD) are at very high risk for cardiovascular morbidity     and mortality. Hyper-lipidemia, a traditional risk factor for Cardiovascular Disease (CVD),     occurs early in the progression of kidney failure; timely identification and intervention is     prudent. Currently, there is no known effective therapy for hypertriglyceridemia, the most     common lipid abnormality. n-3FA, in doses ranging from 2-6 g/day have effectively lowered     elevated triglyceride (TG) levels by 20-50% in a variety of adult populations; however, their     use in children with CKD has not been tested in a randomized controlled fashion. This study     will provide important information on the safety, efficacy and tolerance of n-3FA in lowering     elevated TG levels in children and adolescents with CKD.   "
246373|NCT01088789|"     The purpose of this study is to evaluate the safety and feasibility of long term boost     vaccination of a lethally irradiated, allogenic pancreatic tumor cell vaccine transfected     with the granulocyte macrophage colony-stimulating factor (GM-CSF) gene alone or given in     combination with either a single intravenous dose or daily metronomic oral doses of     cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the     head, neck, tail or the uncinate process of the pancreas.   "
246374|NCT01088802|"     This research is being done to try to reduce radiation side effects that happen with the     standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy     are standard treatment for people with squamous cell carcinoma of the oropharynx.      The study will look at giving a slightly smaller dose of radiation (de-intensification) to     see if regularly expected late toxicities (two years after receiving treatment) can be     reduced. This study will also try to see if the smaller dose of radiation is equally     effective at treating the cancer and to see if it improves quality of life. Along with this     radiation treatment plan some participants in this study will have surgery on their tumor and     or receive chemotherapy (cisplatin or carboplatin). The possible surgery and or chemotherapy     will be up to the participant's doctor.      Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is     required for this study. Some studies have suggested that HPV-related cancer is biologically     and clinically different as compared to non-HPV-related cancer. Some studies have found that     patients with HPV-related oropharynx cancer have a better response to treatment. This test     will help researchers learn more about HPV-related cancer.   "
246375|NCT01088815|"     This is an open-label, single arm, multi-center, Phase II trial to evaluate the progression     free survival in patients with metastatic adenocarcinoma of the pancreas treated with a     hedgehog inhibitor (GDC-0449) in combination with chemotherapy (gemcitabine and     nab-Paclitaxel).   "
246376|NCT01088828|"     The purpose of this study is to:        1. compare structural variations observed in the calf and foot of the clubfoot mouse          model(pma)with human clubfoot patients antenatally and postnatally;        2. identify features that might be used in future large scale studies to delineate a          subtype of human clubfoot associated with lack of response to standard 'Ponseti'          manipulation treatments.   "
246377|NCT01088841|"     The purpose of this study is to determine the functional significance of sweet taste     receptors in the secretion of GI satiety peptides by using a specific sweet taste receptor     antagonist to block sweet taste perception in the gut.   "
246378|NCT01088854|"     Acute effects of CPAP on diastolic function in patients with compensated heart failure (CHF)     are unknown. The investigators hypothesized that acutely CPAP improves diastolic function,     which is associated with increases exercise tolerance.      Objective: To evaluate the acute effects of CPAP on functional capacity and diastolic indices     of patients with CHF. This is a randomized trial including 44 patients with compensated heart     failure (functional classes II or III, NYHA). Patients will be allocated in CPAP(CPAP with     10cmH2O) or simulated CPAP (null pressure) after computed randomization, in a 1:1 ratio. All     subjects shall complete a 6-minute walk test (6MWT) before and after CPAP (30 minutes; 10 cm     H2O pressure). Doppler-echocardiogram will be performed before and at the end of CPAP.     Wilcoxon or paired t tests were used to compare results, with significance level at p < 0.05.   "
246379|NCT01088867|"     The investigators hypothesize that acupuncture modifies the DNIC efficiency and that DNIC can     serve as a predictor to identify 'good responders' to acupuncture early in therapy.   "
246380|NCT01088880|"     Establish the safety and efficacy of 3 months treatment with canakinumab in patients with     colchicine resistant Familial Mediterranean Fever.   "
246381|NCT01088893|"     This is a randomized controlled pilot study investigating signals involved in drug resistance     to chemotherapy.      Patient will be randomized to undergo observation or to receive Everolimus after completion     of neoadjvuant treatment (anthracycline and/or taxane-based) and before surgery. The patients     will be monitored for efficacy and safety.   "
246385|NCT01088945|"     Infants born prematurely or with complex congenital abnormalities are surviving to discharge     in growing numbers and often require significant monitoring and coordination of care in the     ambulatory setting. The specific aims of this project are to determine the effectiveness of a     redesigned discharge process that includes a Health Coach and an expanded discharge binder to     improve health outcomes in the post discharge follow-up period as compared with usual care.     The outcomes to be evaluated include the occurrence of adverse events in the post-discharge     period, quality of follow up care, and caregiver satisfaction with the process.   "
246386|NCT01088958|"     The purpose of the study is to evaluate the effectiveness of household-based distribution of     evidence-based health products and to measure the health impact of these combined     interventions on a population basis.   "
246387|NCT01088971|"     Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel     syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in     changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64     patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre     controlled clinical trial. Patients will be randomized to receive either 2 capsules/day     Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to     Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL)     scores will be also monitored.   "
246388|NCT01088984|"     The primary objective of phase 1 of this study is to establish the recommended phase II dose     (RP2D). The primary objective of phase 2 of this study is to evaluate the safety and efficacy     of bendamustine at the recommended pediatric dose for the treatment of pediatric patients     with relapsed or refractory acute leukemia.   "
246389|NCT01088997|"     The purpose of this pilot study is to determine a safe dose of milrinone to use in a larger     study of babies with persistent pulmonary hypertension of the newborn (PPHN).   "
246390|NCT01089010|"     The primary objective of this study is to demonstrate a pharmacodynamic effect of CK 2017357     on measures of skeletal muscle function or fatigability in patients with ALS.   "
246391|NCT01089023|"     This open-label single-arm study will evaluate the safety, tolerability and efficacy of     tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who     experience an inadequate clinical response to a stable dose of non-biologic disease modifying     anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be     administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be     administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6     infusions. The anticipated time on study treatment is 24 weeks. The target sample size is     50-150 patients.   "
246392|NCT01089036|"     We would like to investigate novel diagnostic methods or biomarkers to early predict the     success of ECMO therapy for cardiogenic shock patients during the early stage after ECMO     treatment.   "
246393|NCT01089049|"     The purpose of this study is to determine if a supplemental formula can beneficially alter     the ratio of urinary estrogen metabolites.   "
246394|NCT01089062|"     Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by     Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.   "
246395|NCT01089075|"     The purpose of this study is to evaluate the efficacy of hydrocortisone replacement therapy     in patients with partial cortisol deficiency after traumatic brain injury or subarachnoid     hemorrhage on cognitive function.   "
246396|NCT01089088|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving     gemcitabine hydrochloride and cisplatin together with sunitinib malate may kill more tumor     cells.      PURPOSE: This phase II trial is studying the side effects of giving gemcitabine hydrochloride     and cisplatin together with sunitinib malate and to see how well it works as first-line     therapy in treating patients with locally advanced and/or metastatic transitional cell     carcinoma of the urothelium.   "
246397|NCT01089101|"     This phase I/II trial studies the side effects and the best dose of selumetinib and how well     it works in treating or re-treating young patients with low grade glioma that has come back     (recurrent) or does not respond to treatment (refractory). Selumetinib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth.   "
246398|NCT01089114|"     Background:      - Antiretroviral therapy has increased the lifespan of people with human immunodeficiency     virus (HIV), but recent research suggests that people with HIV also have an increased risk of     developing cardiovascular disease. To better understand the prevalence and effects of heart     disease in people with HIV, researchers are interested in comparing heart imaging and     metabolism studies to see if there are differences between HIV-positive and HIV-negative     people.      Objectives:      - To study metabolism and heart function in people with HIV compared with healthy     HIV-negative volunteers.      Eligibility:      - Individuals at least 18 years of age who either have been diagnosed with HIV or are healthy     HIV-negative volunteers.      Design:        -  Participants will be evaluated with a physical exam, detailed medical history, and          routine blood and urine tests including HIV testing.        -  Participants will have the following imaging scans:        -  Cardiac magnetic resonance imaging (MRI) to study the health of the heart and blood          vessels        -  Magnetic resonance spectroscopy (MRS) of the heart, liver, and skeletal muscle        -  Cardiac computerized tomography (CT) scan to measure calcium levels in the heart and          nearby arteries        -  Dual-energy x-ray absorptiometry (DEXA) scan to measure body fat and muscle mass.        -  Stable isotope infusion to evaluate how the body processes fat (which will require an          overnight stay before the test)        -  Participants will also have blood tests, an echocardiogram, and an electrocardiogram to          evaluate heart function....   "
246399|NCT01089127|"     This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo     and salmeterol.   "
246400|NCT01089140|"     Investigation of tranexamic acid (TXA) for reducing perioperative blood loss and transfusion     requirement in pediatric patients with secondary scoliosis undergoing posterior spinal     fusion.   "
246401|NCT01089153|"     Current spirochaete infection identification and diagnostic strategies have important     limitations. Recent development may allow for an improvement in diagnostic, screening and     survey capabilities. The goal of this study is to evaluate blood, urine and fecal samples     from a variety of sources and generate information on the occurrence and epidemiology of     spirochetes in the general and at risk populations.   "
246402|NCT01089166|"     Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test     formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference     formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers under fasting     condition.      Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment,Crossover Study under fasting     condition.   "
246403|NCT01089179|"     Objective: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single- Dose     Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test     formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet     (Reference formulation, Bristol- Myers Squibb company, USA) in Healthy Volunteers under Fed     Conditions.      Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment, Crossover Study under fed     condition.   "
246404|NCT01089192|"     Objective:      To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test     formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet     (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under     Fasting Conditions.      Study Design:      An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study   "
246405|NCT01089205|"     Objective:      To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test     formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet     (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under Fed     Conditions.      Study Design:      An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study   "
246406|NCT01089218|"     Fever can develop after fiberoptic bronchoscopy (FB) in about 2.5 - 16 % of adult patients.     We evaluated the impact of oral amoxicillin/clavulanate (AC) on incidence of     postbronchoscopic fever and pneumonia.   "
246407|NCT01089231|"     The aim of this study is to investigate the effects of short- and long-term intervention with     EPA and DHA-rich fish oil on gene expression profiles in healthy and hyperlipidemic males.   "
246408|NCT01089244|"     The aim of the study is to compare the two imaging modalities perfusion weighted MR-imaging     and FET-PET in their ability to provide an accurate histological evaluation of low grade     glioma and to reveal focal abnormalities within a homogeneously appearing tumor.     Additionally, therapeutic effects should be assessed during a time period of two years.   "
246409|NCT01089257|"     Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep     (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or     functional precociously found among patients SAS? Secondary objectives:        1. Which are the anthropometric parameters and/or of severity of SAS allowing to anticipate          occurred of early of the cardiac function and/or rhythmic anomalies found among patients          SAS?        2. Do there exist biological markers who allow to anticipate the early vascular lesions or          the anomalies beginners of the cardiac function?        3. Which are the cardiovascular effects of a treatment of SAS by Continuous Positive          Pressure (PC) after 3 to 6 months of treatment?        4. Do the identified early cardiovascular attacks and/or the biological anomalies make it          possible to predict occurred of cardiovascular events in this population of patients          carrying SAS (followed longitudinal at 5 years)?   "
246410|NCT01089270|"     Parkinson Disease is one of the most common neurodegenerative illnesses. First degree     relatives of Parkinson patient are in high risk for developing the disease. We will try to     detect early changes in brain metabolism before the appearance of Parkinson symptoms.      Participants: first degree relatives of diagnosed Parkinson patients that carry a gene     mutation in either LRRK2 or GBA genes.      The examination results will be given to the participants by a doctor from the neurology     department.   "
246411|NCT01089283|"     Parkinson disease is one of the most common neurodegenerative illnesses. The disease is     characterized by decrease in dopamine levels and decrease in the number of dopaminergic     neurons and dopamine receptors. There are gene mutations that increase the risk for the     disease. Two of those mutations are on the LRRK2 gene and on GBA gene. It is yet unknown if     there is a difference between the metabolic brain function of Parkinson patients that carry     one of the two mutations to Parkinson patients with no known mutation.      Participants: diagnosed Parkinson patients that carry a gene mutation in either LRRK2 or GBA     genes, Parkinson patients with no known mutation and healthy volunteers as a control group.      The participants will go through both examinations DAT SCAN and PET CT SCAN at the Tel Aviv     Sourasky Medical Center Nuclear Medicine Institute.      The examination results will be given to the participants by a doctor from the neurology     department.   "
246412|NCT01089296|"     This is a pragmatic randomized controlled study. The purpose of the study is to evaluate the     practice and effect of customised physiotherapy on preterm infants`motor development when the     intervention is performed over a period of three weeks while the infant resides in the     neonatal intensive care unit. The study will also attempt to analyze the parents` experiences     in being actively involved in education and practice of the intervention designed to promote     the child`s motor development, and the effects on the parent-child relationship in the short     and long term.The children are followed up until a corrected age of two years. This study     consists of a pragmatic randomized controlled trial and a qualitative study.   "
246413|NCT01089309|"     The present study investigated the long-term (12 months) effect of spironolactone treatment     on glucose homeostasis, metabolic parameters and vascular properties.   "
246414|NCT01089322|"     Several studies have demonstrated the efficacy of asthma treatment but despite being     correctly diagnosed, conveniently prescribed and adherent to the therapeutics, 5% to 10% of     asthmatics do not reach disease control.      The aim of this study is to measure asthma control, evaluate inflammatory and functional     characteristics, describe comorbidities and aggravating factors and phenotypes derived from     the characteristics of a severe asthmatic population followed at an outpatient university     service in Sao Paolo, Brazil.   "
246415|NCT01089335|"     The standard surgical treatment for highly differentiated papillary thyroid cancer > 10 mm     according to recent national and international guidelines, is total thyroidectomy and central     lymphnode clearance, and for patients with cytology indicating thyroid neoplasia of unclear     malignant potential hemithyroidectomy on the side of the tumour.      The study investigates if the sentinel lymphnode (SN)        -  Reliably (with high sensitivity and specificity), can predict the pathological findings          of the lymphnodes in the central compartment in patients with highly differentiated          papillary thyroid cancer        -  Is useful to aid in the final diagnosis and staging of thyroid neoplasias of unclear          malignant potential, and could be used to select patients for further central lymphnode          revision.   "
246416|NCT01089348|"     This is a phase II multicenter randomized open-label clinical study that will determine     whether treatment with Lactofiltrum (orally administered tablets) in combination with     antibiotic therapy (metronidazole) is effective in women with bacterial vaginosis.     Lactofiltrum is a composite drug that includes enterosorbent lignin and prebiotic Lactulose.     It's supposed that supplement of Lactofiltrum to a standard therapy of bacterial vaginosis     (metronidazole administered orally) improves women's general state, leads to better recovery     of clinical, microbiological, biochemical and histological features of the disease.   "
246417|NCT01089361|"     The aim of the study is to assess the effect of short-term infusion of ketamine at analgesic     dosage on the immune response, morbidity and mortality among patients suffering from septic     shock. We hypothesize that ketamine will modulate the cytokine response to sepsis and reduce     morbidity and mortality.   "
246418|NCT01089374|"     In 2008 a research study conducted by Dr. Barth involving 46 women determined that whole     breast radiation therapy performed after a lumpectomy of borderline and malignant phyllodes     tumors decreases rate of recurrence. None of the 46 participants developed a local     recurrence.      Based on information we have learned from research studies, we recommend whole breast     radiation therapy for women with malignant and borderline phyllodes tumors after they receive     a lumpectomy.      New methods for delivering breast radiotherapy are being developed that allow radiation to be     delivered solely to the site of the surgical resection. This is called partial breast     radiation. The main advantage of partial breast radiation is that it simplifies treatment for     the patient. Radiation is delivered twice a day for 5 days, rather than 5 days per week for 6     weeks. The main concern is that partial breast radiation might miss other sites of breast     cancer in the breast receiving the radiation.      Evidence is accumulating from research studies that partial breast radiation therapy after     surgical removal of the more common type of breast cancer, invasive ductal carcinoma, the     breast results in rates of local recurrence that are comparable to those seen after whole     breast radiation therapy.      In contrast to patients with invasive ductal cancers of the breast, it is very rare for     patients to have phyllodes tumors that appear in more than one area of the breast. Review of     research data determined that cancer recurrences seen in patients with phyllodes tumors that     had undergone lumpectomies were almost always at the original tumor site. Therefore, partial     breast radiation is likely to be as effective as whole breast radiation therapy after     resection of malignant phyllodes tumors.      The purpose of the study is to determine what the chances are that a phyllodes tumor will     recur in the breast when the breast is treated with partial breast radiation therapy after a     lumpectomy.   "
246419|NCT01089387|"     Erectile dysfunction is a frequent adverse event after radical prostatectomy for prostate     cancer.      It is the consequence of penile vascular damage, mainly arterial insufficiency and venous     leakage associated with fibrosis of the corpus cavernous. Apoptosis of penile cells,     including mesenchymal cells, smooth muscle cells and endothelial is believed to play an     important role in the pathophysiology of post prostatectomy erectile dysfunction.      Bone marrow mononucleated cells (BMMNC) contain different cell types that may replace the     damaged penile cells after radical prostatectomy. These are mainly: mesenchymal stem cells,     endothelial progenitor cells and hematopoietic stem cell. Intracavernous injection of BMMNC     may therefore find application in the treatment of post prostatectomy erectile dysfunction.      The aims of this phase I-II study is to test the safety of autologous intracavernous BMMNC     injection and to evaluate benefit for the patient concerning recovery of natural erection.     Patients with penile vascular abnormality (echo-doppler) and localized prostate cancer     (considered as cured by radical prostatectomy) will be included in this study.      Four different doses of BMMNC will be tested.   "
246420|NCT01089400|"     The influenza A/H1N1v pandemic virus causes severe pneumonia that can lead to acute     respiratory distress syndrome and death even in healthy young individuals. The respective     roles of viral replication, bacterial infection and immune alterations of the host during     such severe influenza H1N1v infection need to be clarified in order to optimize patients     care. In this context, we aim to study immune and virological parameters in bronchoalveolar     lavage fluid during severe influenza A/H1N1v infection with pulmonary involvement in     intensive care unit. Results will be correlated to bacterial or viral pulmonary co-infections     and to peripheral blood immune and virological parameters.   "
246421|NCT01089413|"     This observational study will assess the treatment duration, progression-free survival,     reason for stopping treatment and patient and tumor characteristics of bevacizumab [Avastin]     treatment in patients with metastatic colorectal cancer. Data will be collected for     approximately 34 months. The target sample size is >300 patients.   "
246422|NCT01089426|"     This study examines the hypothesis that administering intravenous fish oil, in lieu of     intravenous soybean oil, can ameliorate the progression of PN-associated cholestatic liver     disease in pediatric patients with elevated direct bilirubin requiring PN for more than 30     days.   "
246423|NCT01089439|"     Acute chest syndrome is a severe sickle cell disease complication in children requiring blood     transfusion therapy to prevent acute respiratory failure and death. Nitric oxide is a potent     vasodilator that could reverse pulmonary vascular occlusion and restore normal oxygenation.     The randomized trial will test that hypothesis.   "
246438|NCT01089634|"     Primary Objective:      To characterize left ventricular (LV) threshold behavior over time using daily left     ventricular capture management (LVCM) measurements.      Study Design:      This is a multicenter, prospective, non-interventional study with patients receiving their     first cardiac resynchronisation therapy-implantable cardioverter defibrillator (CRT-ICD)     device. The study design, based on the primary objective, is an observational examination of     LV thresholds over time. Daily left ventricular threshold measurements will be collected     using the LVCM feature. Up to 150 patients will be enrolled in Canada to evaluate the primary     objective at up to 15 study centers.      Data will be collected at Baseline, Implant, 12 months post-implant and all regularly     scheduled follow-up visits up to 12 months post-implant.      Devices:      The ConcertoTM CRT-ICD device and future Medtronic CRT-ICD devices containing the LVCM     feature will be used in this study.   "
246439|NCT01089647|"     In children with mild apnea combined therapy with an inhaled nasal steroid and a medication     that decreased nasal congestion (montelukast) was shown to be effective. We are testing to     see if this combination works in adults with mild apnea as well.   "
246424|NCT01089452|"     This study is looking to evaluate which drug combination, olmesartan/amlodipine or     perindopril/amlodipine, is better at lowering blood pressure in people with mild to moderate     hypertension. The investigators will be enrolling people who are either currently taking     medication to lower their blood pressure or who have been recently diagnosed with high blood     pressure and are not yet on medication.      Patients on medication for their blood pressure will be asked to stop taking this medication     for 2 to 4 weeks. If their blood pressure is suitable (not too high or low) they will be     randomised to one of their treatment arm:      Group 1 will receive Perindopril on its own (5mg for 4 weeks followed by 10mg for 8 weeks).     There will be 80 patients in this group.      Group 2 will receive Perindopril and Amlodipine together (5mg/5mg for 4 weeks, 10mg/5mg for a     further 4 weeks then 10mg/10mg for the final 4 weeks). There will be 80 patient in this     group.      Group 3 will receive Olmesartan and Amlodipine together (20mg/5mg for 4 weeks, 40mg/5mg for a     further 4 weeks then 40mg/10mg for the final 4 weeks). There will be 120 patients in this     group.      During the study we will measure the patients blood pressure and heart rate, weight and     perform routine blood tests. They will also have ECGs (3 occasions) and 24 hour blood     pressure monitor (4 occasions).      At the end of the study patients pre-study medication will be restarted or they will be put     on to a suitable alternative.   "
246425|NCT01089465|"     During the last years, the investigators were the witness to the increase of a old emerging     pest due to bed bugs (Cimex lectularius) in the world. Insecticides resistances apparitions     and internationals transports increases seem to be the reasons of the pest. Cimex lectularius     as vector of parasites, bacteria or virus was often suggested although not much observation     are recently investigated in France. This study intends to examine the vectorial ability and     the direct pathogenicity of Cimex lectularius.   "
246426|NCT01089478|"     The investigators are doing this study to learn more about the cause of back pain with or     without pain shooting down one or both legs. The investigators specifically want to know if     cells that move into injured areas of the body are present in a space in the spine (epidural     space) of patients with back pain and with or without shooting pain. The investigators will     collect cells when patients are being treated, then examine the cells using a microscope. The     investigators also will shine different colors of light into the epidural space to see if     there is a correlation between how different colors of light are reflected and the types of     cells present.   "
246427|NCT01089491|"     The purpose of this study to determine if cells collected give us information about what is     causing a patient pain can be detected and connected with epiduroscopy images (pictures taken     with a small fiber optic scope). We want to determine if abnormal areas are the source of     that pain by using a catheter to provide a brief, low intensity electrical stimulation. We     also want to determine if there are cells in the epidural cavity (area surrounding the spinal     cord) of patients who have low back pain with or without pain shooting down one or both legs     that provide information about what is causing the pain.   "
246428|NCT01089504|"     The treatment of infants with medications after their seizures have stopped is very variable.     No one knows if continuing treatment with phenobarbital for up to several months is helpful     or harmful. This clinical trial is designed to help answer that question and provide data     that will help determine standard of care for these children.   "
246429|NCT01089517|"     The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous     injection when administered in combination with Lucentis® against a control of Lucentis®     alone in subjects with subfoveal choroidal neovascularization secondary to age-related     macular degeneration (AMD).   "
246430|NCT01089530|"     Objectives:        -  To study the possible effects of an intensive lifestyle change program on, the plasma          fibrinogen levels in patients with no cardiovascular disease, with a high fibrinogen and          normal cholesterol levels, and moderate Cardiovascular Risk (CVR).        -  To analyse whether or not the effect on fibrinogen is independent of the effect on          lipids.      Methods: Controlled, randomised clinical trial in 13 Basic Health Areas (BHA) in L'Hospitalet     de Llobregat (Barcelona) and Barcelona city. Of the 436 patients between 35 and 75 years with     no cardiovascular disease, with a high plasma fibrinogen (> 300 mg/dl) and a plasma     cholesterol < 250 mg/dl, 218 received a more frequent and intensive intervention, consisting     of advice on lifestyle changes and treatment. The follow up frequency of the intervention     group was every two months. The other 218 patients continued with their usual care in the     BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were     assessed.   "
246431|NCT01089543|"     The purpose of this study is to assess the efficacy and safety of rabeprazole compared to     placebo in Japanese subjects with Functional Dyspepsia.   "
246432|NCT01089556|"     This study will investigate the efficacy of a combination treatment of duloxetine +     pregabalin compared with the maximal dose of each drug in monotherapy, in patients with     diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard     recommended dose of either drug. It will provide an answer to a common clinical question,     namely, is it better to increase the dose of the current monotherapy or to combine both     treatments early on, in patients who do not respond to standard doses of duloxetine or     pregabalin.   "
246433|NCT01089569|"     The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns,     HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of     insulin glargine and exenatide to metformin.   "
246434|NCT01089582|"     This study assessed the Hr QoL (Health related Quality of life) of subjects with mild to     moderate AD, who received ARICEPT under usual clinical practice.   "
246435|NCT01089595|"     Patients with advanced GIST are treated with imatinib. This study seeks to look at a new     therapeutic agent at the time of tumor progression following treatment with 600-800 mg daily     of imatinib. The study is looking to see if Nilotinib (tasigna) alone or in combination with     imatinib (gleevec) is more effective at controlling disease.   "
246436|NCT01089608|"     The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus     placebo eye drops on the global ocular discomfort (VAS).   "
246437|NCT01089621|"     The purpose of this study is to evaluate the possibility of conducting a larger study in     adolescents with fibromyalgia syndrome.   "
246441|NCT01089673|"     A retrospective molecular diagnostic review on wound care outcomes between two time periods.     The time periods include June, July, August of 2008 and June, July, August of 2009. The     retrospective review would analyze the days of healing during those two timeframes, upon the     introduction of molecular diagnostic testing.   "
246442|NCT01089686|"     This is a single center, multispecialty, randomized double blind placebo control feasibility     clinical trial. The purpose is to evaluate the safety, feasibility and efficacy of     percutaneous transluminal angioplasty in treating extracranial venous obstructive lesions,     and its influence on the clinical outcomes of Multiple Sclerosis (MS) patients that have been     found to have chronic cerebrospinal venous insufficiency (CCSVI).   "
246443|NCT01089699|"     Young women who have finished treatment for breast cancer regularly report a lack of     psychological and social support in their lives. They often continue to struggle with     survivorship issues such as ongoing distress and the challenge of how to rebuild their lives     after treatment. This experiment will compare two online support group (OSG) options to     determine if both forms of support help young breast cancer survivors adjust, by reducing     treatment-related intrusions and helping women re-engage in valued activities and     commitments. It will also test if these 2 types of OSG's help womens' mood, feelings of     loneliness, confidence, and overall life satisfaction. It will explore the processes within     support groups that help to create positive change for young women after cancer treatment.      Previous work by this team in a smaller study has shown that online support groups led by     professional counselors can be carried out over the Internet, and that they produce helpful     benefits for young women survivors of breast cancer. The online groups were comprised of 10     sessions of real time chats, with each session focused on a specific topic. Participants were     provided with an educational manual designed to improve skills for coping after cancer, and     they were instructed to read one chapter a week in preparation for the chats. The women     enjoyed the groups and 3 months after completing the groups, they reported improved quality     of life, lower emotional distress, and enhanced coping. However, a large study to determine     the strength and reliability of these early promising findings is needed. The questions to be     examined are whether trained peers (other young breast cancer survivors) might be able to     facilitate the online groups and provide similar positive benefits for young breast cancer     survivors, and what facilitators can do to maximize positive benefits in online support     groups.      This is a multi-provincial, 3-arm study that will compare a professionally-led OSG (with an     educational manual) and a peer-led OSG (with an education manual) with a group that just     receives the educational manual. Psychological assessment measures given immediately     following the 12 week group, and at 6 months and 12 months follow-up, will determine if one     or both of the study groups effectively improve quality of life, reduce distress, and enhance     self-efficacy and life satisfaction for young breast cancer survivors. Additionally, tests     will be performed to investigate whether discussing emotional matters predicts greater     improvements.   "
246444|NCT01089712|"     The purpose of the study is to determine the best ways to prevent infections after heart     surgery. Participation in the study will last at most 3 months after heart surgery. The study     will only collect information about the care patients receive during the planned surgery. No     new testing or procedures will be done. Patients will receive only the tests or procedures     the doctor already has planned. This kind of study is an observational study, because all     that is planned to do is observe the care patients receive and how well they do during     treatment. The information collected should help to improve the quality of surgical care in     the future.   "
246445|NCT01089725|"     This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab     administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC)     administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of     tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16     weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.   "
246446|NCT01089738|"     This study is designed to look at the safety and blood concentrations of PF-03382792 in     healthy elderly subjects after taking multiple doses for 14 days.   "
246447|NCT01089751|"     This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily     in reducing urgency, urinary frequency and urinary urge incontinence in female patients with     incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.   "
246448|NCT01089764|"     Women diagnosed with breast cancer (BC) at or before the age of 50 experience more distress     and poorer quality of life than women diagnosed later in life. Although adequate spousal     support is a protective factor for women with BC, spouses are often unprepared to handle the     myriad practical and emotional demands posed by the illness. Furthermore, despite the growing     number of recommendations for couple interventions in relation to BC, traditional counselling     approaches may fail to meet the needs of young couples who have unique concerns and tight     constraints on their time. The proposed project addresses the void in the psycho-social     support available to young couples via an innovative, online psychoeducational intervention     tailored specifically to their needs.   "
246449|NCT01089777|"     The study is an open prospective study of coronary flow preferably of the left anterior     descending artery (LAD), by a Transthoracic Parametric Doppler (TPD) system during     conventional exercise stress test. The system is a noninvasive non-imaging device designed to     monitor coronary flow velocity and display the data continuously during exercise stress     tests. The system enables continuous monitoring of coronary flow during resting, stress     loading and recovery phases. The study intent is to improve the stress test predictive value     for CAD.   "
246450|NCT01089790|"     This study will evaluate the long-term safety and efficacy of dutogliptin in patients with     type 2 diabetes mellitus (T2DM).   "
246451|NCT01089803|"     The purpose of this prospective, multi-institutional, observational cohort study is to     determine if an initial surgical approach leads to better function and quality of life than     primary chemoradiation in a subset of patients with advanced hypopharyngeal and laryngeal     cancers.   "
246452|NCT01089816|"     The primary objective of this study is to evaluate the performance of the MSD® Influenza Test     in detecting influenza A and influenza B in subjects presenting with influenza-like-illness     (ILI).   "
246481|NCT01090193|"     Introduction: Cholemia and bacterial translocation with portal endotoxemia are integral in     the pathogenesis of obstructive jaundice (OJ). There is sufficient experimental data about     hemodynamic and histopathologic consequences of OJ. On the contrary, pathologic information     of renal changes in patients with OJ is still lacking. Therefore; the primary objective of     this prospective study is to demonstrate the specific histopathologic changes in kidneys of     patients with short-term biliary tract obstruction receiving a standard perioperative medical     treatment protocol.   "
246507|NCT01090531|"     This observational long-term follow-up study will evaluate demographic, clinical,     histological, biochemical, and virological parameters of patients with chronic hepatitis B     and low viremia who do not require antiviral therapy according to current guidelines. Liver     stiffness values as detected by FibroScan and ARFI will also be collected if available. All     data will be collected at yearly intervals (minimum). Patients included in the study are     followed for up to 10 years. The target sample size is <1000.   "
246453|NCT01089829|"     Foot ulceration is a risk factor that has been associated with early death in patients with     chronic kidney disease. Little is known about the relationship between these risk factors     that develop in patients with kidney failure and the onset of lower limb threatening foot     ulcers.      Diabetes is a major cause of both kidney disease and foot ulceration; however a previous     study reported that a significant proportion of kidney failure patients on haemodialysis     treatment without a diagnosis of diabetes also had these risk factors that could lead to foot     ulceration.      The aim of this study will be to identify these risk factors associated with lower limb     threatening disease in patients with advanced kidney failure. In addition a robust screening     tool will be developed to address the reliability and validity of current screening methods     deemed to be gold standard in the assessment of diabetic foot disease in this Chronic Kidney     Disease population.      It is important to follow the progression of these risk factors as the kidney failure     worsens. The study also intends to screen patients as they start dialysis treatment and     follow their progress with respect to risk factors known to predispose to foot ulceration     over their first year of treatment. The proposed outcome from this study is to develop a     strategy to identify patients with kidney failure that are at risk of foot ulceration and     intervene at an early point to prevent the life threatening complications associated foot     disease.   "
246454|NCT01089842|"     The purpose of this study is to evaluate the efficacy of motivational interviewing-based     coaching to increase physical activity to achieve guidelines recommendations for     cardiovascular disease prevention.   "
246455|NCT01089855|"     The trial is designed to evaluate the efficacy and tolerability of carbamazepine in     neuropathic pain in diabetic patients   "
246456|NCT01089868|"     The aim of this study is to establish FET-PET as an additional therapy assessment parameter     in patients diagnosed with a glioblastoma multiforme receiving radiochemotherapy and adjuvant     chemotherapy after previous resection or biopsy.   "
246457|NCT01089881|"     Choline is one of the components of phosphatidylcholine, an essential element of     phospholipids in the cell membrane. Some malignant cells show their ability to actively     incorporate choline to produce phosphocholine and phosphatidylcholine to facilitate tumor     cell duplication. The efficacy of 18F-fluorocholine (18F-FCH) for localizing primary or     metastatic prostate cancer has been recently reported in limited studies. This study will be     conducted to delineate the effectiveness of 18F-FCH PET in (1) differentiating benign     prostate hypertrophy (BPH) from prostate cancer, (2) staging prostate cancer, (3)     following-up patients with prostate cancer after initial curative therapy.   "
246458|NCT01089894|"     The ability of 18F-FDG PET for characterizing lung nodule remains a challenge, especially in     Taiwan where tuberculosis is still prevalent.      18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT), a radiolabeled analog of thymidine, can be     trapped within the cytosol after being monophosphorylated by thymidine kinase-1 (TK-1), a     principle enzyme in the salvage pathway of DNA synthesis. It has been demonstrated in cell     culture, animal models and clinical studies that the accumulation of 18F-FLT is closely     associated with cellular proliferation. 18F-FLT PET may be more accurate than 18F-FDG PET in     differentiating benign from malignant pulmonary lesions. In addition, the correlation between     18F-FLT uptake and cellular proliferation hints the usefulness of 18F-FLT PET for monitoring     treatment response with cytostatic anticancer drugs.      We thus design this prospective 3-year project        1. To evaluate the usefulness of 18F-FLT PET and 18F-FDG PET in differentiating benign from          malignant pulmonary nodules in Taiwan where tuberculosis is still prevalent.        2. To assess the usefulness of 18F-FLT PET in early prediction of therapeutic response of          platinum-based chemotherapies or EGFR inhibitors for NSCLC patients.        3. To correlate 18F-FLT uptake with EGFR mutation status, therapeutic response and survival          for NSCLC patients.   "
246459|NCT01089907|"     To study the genomics with cell cycle and lymphocyte differentiation in disease, remission     and relapse of childhood acute lymphoblastic leukemia. Then correlate these data with age,     white cell count, cytogenetic changes, response to the chemotherapy and prognosis.   "
246460|NCT01089920|"     Coffee and green tea are 2 widely consumed beverages. Both contain polyphenol antioxidant     compounds (chlorogenic acids for coffee and catechins for tea). The bioavailability of     catechins is somewhat known and has been referenced in the literature. However,     bioavailability data from tea infusion is non-existent, even though it reflects better how     consumers drink this beverage. In addition, bioavailability of coffee chlorogenic acids is     less understood and no dose response study has been reported so far in the literature. Thus,     there is a great need to understand and reinforce our knowledge on the bioavailability of     coffee and tea polyphenol compounds.   "
246461|NCT01089933|"     The purpose of this study is to determine if the combination of thoracic paravertebral block     and multimodal analgesia will decrease chronic pain and arm morbidity in patients undergoing     breast cancer surgery with lymph node dissection as compared to patients receiving local     anesthesia with multimodal analgesia.   "
246462|NCT01089946|"     The purpose of this study is to investigate the cardiovascular changes during early     postoperative mobilization of hip arthroplasty patients.   "
246463|NCT01089959|"     The purpose of this study is to determine if esomeprazole 40 mg. once daily improves not only     nighttime symptoms but also significantly reduces conscious awakenings associated with     gastroesophageal reflux and consequently improves sleep quality.   "
246464|NCT01089972|"     The aim of this randomized study was to compare the impact of two different radial arterial     catheters - 20G and 22G - on the changes of diameter, blood flow and velocity of radial     artery and ulnar artery after induction of anesthesia and after cannulation.   "
246465|NCT01089985|"     The purpose of this study is to examine the efficacy and safety of autologous serum eye drops     in people with recalcitrant dry eye.   "
246466|NCT01089998|"     Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography)     images obtained after a single intravenous injection of BAY86-9596 in patients with cancer     and inflammation   "
246482|NCT01090206|"     Study will look at baseline Vitamin D levels, calcium, albumin, liver enzymes, testosterone,     osteocalcin, urine N telopeptides, bone mineral density, nutritional assessment and physical     activity assessment of boys with hemophilia A or B (ages 2-20 yrs). Patients with low vitamin     D levels will receive therapeutic doses of Vitamin D. At end of one year follow up studies     will be repeated.   "
246467|NCT01090011|"     The primary objective of this trial is to determine the maximum tolerated dose (MTD) and     recommended Phase II doses for the combination of BIBW 2992 and cetuximab in patients with     non-small cell lung cancer and acquired resistance to erlotinib or gefitinib.      Overall safety, pharmacokinetics and anti-tumor activity for the combination of BIBW 2992 and     cetuximab in patients with non-small cell lung cancer and acquired resistance to erlotinib,     gefitinib or BIBW 2992 will be evaluated as secondary objectives.      Initially a standard, 3+3 dose escalation will be performed to determine the MTD of BIBW 2992     when administered together with cetuximab in patients with advanced non small cell lung     cancer and acquired resistance to erlotinib or gefitinib.      Subsequently, the preliminary efficacy and safety of the identified MTD of cetuximab     administered with BIBW 2992 will be explored in a combo arm via a further expansion of MTD     cohort up to a total of 140 EGFR mutation positive NSCLC with acquired resistance to     erlotinib/gefitinib.      Furthermore, the safety and preliminary anti-tumor activity of the combination therapy in     EGFR mutant NSCLC patients who developed acquired resistance (AR) to BIBW 2992, will be     assessed in a sequential arm. The sequential arm will use a two-stage design with an early     stopping rule after 12 patients with acquired resistance to BIBW 2992 have received up to 5     courses of BIBW 2992 plus cetuximab. If no responses are seen in 12 patients during 5 courses     of combination therapy, accrual in the sequential arm will stop. If 1 or more responses are     observed, the sequential arm will expand up to about 40 patients.   "
246468|NCT01090024|"     To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening     (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid     in symptomatic asthma patients.   "
246469|NCT01090037|"     In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as     the primary disease:        -  To confirm the superiority of TRK-100STP over placebo        -  To determine the recommended therapeutic dose in the 2 doses of TRK-100STP        -  To assess the safety of TRK-100STP   "
246470|NCT01090050|"     This study is being conducted to evaluate the hypothesis that use of Treximet in patients     with chronic migraine, when used on a short term daily basis and as rescue for break through     attacks, will reduce migraine frequency and impact.   "
246471|NCT01090063|"     The purpose of this study is to determine the short and long term safety and effectiveness of     ustekinumab in subjects with moderate to severe chronic palmar plantar psoriasis.   "
246472|NCT01090076|"     This research aims to address the gap in the studies done and test the effects of a     commercial mixture of 7 g of Arginine, 7 g Glutamine and 1.2 g HMB* twice a day on hard to     heal pressure ulcers in an Asian patient cohort in an acute healthcare setting.   "
246473|NCT01090089|"     In this study for elderly myeloma patients lenalidomide plus low-dose dexamethasone until     progression is being compared with age-adjusted tandem high-dose melphalan 140 mg/m²     augmented by induction with 3 cycles of lenalidomide plus low-dose dexamethasone before     transplantation and lenalidomide maintenance after transplantation.   "
246474|NCT01090102|"     The objective of this study is to determine whether 12 weeks of mesalamine therapy added to a     standard HIV treatment decreases systemic immune activation and inflammation in HIV-infected     patients, possibly resulting in better recovery of the immune system. The study hypothesis is     that decreasing inflammation directly in the gut may decrease both of these potential causes     of chronic inflammation, potentially resulting in an immunologic benefit.   "
246475|NCT01090115|"     To evaluate the safety and activity of ART-123 in reducing death in subjects with sepsis and     disseminated intravascular coagulation.   "
246476|NCT01090128|"     The purpose of this clinical trial is to test whether treatment of patients with breast     cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and     Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24     patients may be enrolled in this study at the Mitchell Cancer Institute. All patients     enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin,     and Cyclophosphamide.   "
246477|NCT01090141|"     The purpose of this study is to assess the drug concentration of Micafungin amongst healthy     volunteers having different weight groups.   "
246478|NCT01090154|"     The purpose of this study is to determine if Cimzia (certolizumab pegol) is an effective     treatment for patients with Ulcerative colitis.   "
246479|NCT01090167|"     This study is sponsored by Genzyme Japan K.K. The purpose of this study is to assess the     safety, tolerability and pharmacokinetics of Clofarabine (JC0707) intravenously administered     to Japanese adult patients with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia     (AML) at 20, 30, and 40 mg/m2/day on a 5-day dose schedule.   "
246480|NCT01090180|"     The purpose of this study is to examine the effects of glucocorticoid administration     following traumatic memory reactivation on psychiatric symptoms in veterans with     combat-related PTSD, in addition to examining the effects of glucocorticoid administration     following traumatic memory reactivation on physiological responses to veteran's personal     combat memories. The following hypotheses will be tested:        1. Subjects who receive an exogenous glucocorticoid after traumatic memory reactivation          will demonstrate fewer PTSD and depression symptoms one week later, compared to those          who receive a placebo after traumatic memory reactivation.        2. The glucocorticoid reduction effects will be cumulative; that is, reduction will          persist, and further post-reactivation glucocorticoid administration will further reduce          symptoms        3. Decreases in PTSD and depression symptoms will persist at 1, 3, and 6 months for          subjects receiving an exogenous glucocorticoid compared to those subjects receiving          placebo        4. Subjects who receive an exogenous glucocorticoid after traumatic memory reactivation          will demonstrate decreased physiological responses one week later, compared to those who          receive a placebo after traumatic memory reactivation.        5. As with the psychological measures, suppression of the physiological measures will          demonstrate both persistence over time and accumulation with subsequent          post-reactivation glucocorticoid administration.   "
246483|NCT01090219|"     The aim of this study was to analyze the shrinkage of two different screens in the repair of     inguinal hernias in men . 32 patients with unilateral inguinal hernia were assigned randomly.     A Lichtenstein tension-free hernia repair was accomplished by emplacing heavy weight versus     ultralight weight polypropylene meshes for repair of incisional hernia, marked next to the     lips with six titanium clips (LT200).   "
246484|NCT01090232|"     Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute     hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where     it is hyperendemic and principally water-borne. In industrialised western countries,     hepatitis E was until recently considered as imported from hyperendemic geographical areas,     but is currently an emerging autochthonous infectious disease. A growing body of data from     Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis     E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through     direct or indirect exposure. Hepatitis E typically causes self-limited acute infection.     However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be     still higher in patients with underlying chronic liver disease. To date, no preventive or     curative treatment of hepatitis E is available.   "
246485|NCT01090245|"     Under funding from the National Institute on Drug Abuse, the UCLA Integrated Substance Abuse     Programs (ISAP), in collaboration with Walden House and the California Department of     Corrections and Rehabilitation, is conducting a five-year study that will involve a     randomized test of the use of incentives with parolees in a community-based residential     substance abuse treatment program to increase treatment admission and treatment retention,     and thereby increase the likelihood of improved outcomes. Study participants will be     recruited from clients in a prison-based treatment program who have a referral to the Walden     House community program. The Admission Phase of the study assesses the effect of an incentive     (voucher) on enrolling in the Walden House program. The Attendance Phase assesses the effect     of incentives on treatment attendance and on post-treatment drug use, crime, and psychosocial     behaviors, including HIV risk behaviors. In addition, an incentive protocol will test whether     an incentive will encourage participation in HIV testing and counseling. The intervention     will last for six months.      Hypothesis 1. The use of incentives will significantly increase subject enrollment in     community treatment.      Hypothesis 2. The use of incentives will significantly increase subject retention in     community treatment.      Huypothesis 3. The use of incentives will significantly increase subject participation in HIV     testing and counseling.      Study participants will be interviewed at baseline and at 12 months following the     intervention. Treatment and criminal justice data will be obtained. Data on acceptability,     satisfaction, and sustainability will be collected from focus groups with staff and clients.   "
246486|NCT01090258|"     The study compares automated settings (Intellivent) with protocolized settings of the     ventilator after cardiac surgery. The settings concern the respiratory rate, the inspiratory     and expiratory pressure and FiO2. The aim of the study is to demonstrate that automated     settings are feasible and safe.      The study design is a randomized controled study. 30 patients will be ventilated with     automated mode and 30 patients with protocolized settings after cardiac surgery.      The hypothesis is that the automated mode allows a safer ventilation with better maintain of     the patient in predefined optimal zone of ventilation.   "
246487|NCT01090271|"     The aim of the study was to evaluate the effect of eccentric strength training for shoulder     abductors on force steadiness in subjects with subacromial impingement syndrome (SIS).   "
246488|NCT01090284|"     The notable development and diffusion of prosthetic surgery of the abdominal wall over the     last few years has led to the introduction of light weight meshes. The efficacy of inguinal     hernia repair with light weight prosthesis, as well as the better or worse biotolerability     with respect to those of light weight, remains questionable in literature, where a clear     answer still remains to be given. If there exists a connection between the quantity of     material implanted, the immunological reaction to the mesh, the induced oxidative stress and     the degree of cicatrization, and consequently the long-term result of the efficacy of the     operation, remains to be demonstrated. There are few studies on the immunological reaction to     polypropylene meshes, and none on the oxidative stress induced by the mesh. Moreover, only     one study has been published that clearly correlates the immunological reaction to the amount     of prosthetic material, but was carried out on only a few patients.      The aim of this research is to show if there is a relationship between the amount of     prosthetic material used and immunological reactions as well as postoperative oxidative     stress, and thus to evaluate, if present, the differences in the biological reaction and     biotolerability between light-weight and heavy-weight meshes on a statistically significant     number of patients.   "
246489|NCT01090297|"     Background: Continuous positive airway pressure (CPAP) is the first line therapy for     obstructive sleep apnea syndrome (OSAS). Two positive airway pressure (PAP) modalities can be     used: Fixed pressure, in which the effective pressure is set and kept constant all night, and     auto CPAP devices where the positive pressure changes during the night depend on patient's     requirements.      Hypothesis: Pressure variations associated with autoCPAP functioning can lead to sleep     fragmentation and alterations in sleep structure. This can limit blood pressure dipping     during sleep and then impact clinical blood pressure reduction.      Main objective: To compare in a randomized controlled trial 4 months clinical blood pressure     (BP) evolution depending on CPAP mode: fixed pressure versus autoCPAP. Secondary outcomes:     Evolution of arterial stiffness, biological parameters, quality of life and symptoms.      Methods: Patients will be randomised depending on CPAP mode. Baseline and 4 months evaluation     will include: 24-h ambulatory blood pressure monitoring, clinical BP measurements and     carotid-to-femoral pulse wave velocity (PWV). Patients will also complete quality of life and     symptoms questionnaires.      2 interim analysis will be carried out when 150 and 220 patients respectively will have     completed the study. The Peto's method will be used to correct the p-values.   "
246490|NCT01090310|"     This extension study will assess the safety and efficacy of AIN457 versus placebo for     maintaining uveitis suppression when reducing systemic immunosuppression   "
246491|NCT01090323|"     The safety, tolerability, effects on liver iron concentration and pharmacokinetics of ICL670     is studied in sickle cell disease patients with transfusional hemosiderosis.   "
246506|NCT01090518|"     This study seeks to examine the efficacy of hydrocortisone administration in the augmentation     of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested     treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD).     The augmentation builds on both the translation of neuroscience findings demonstrating the     effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other     investigators demonstrating beneficial effects of GCs in reducing traumatic memories in     trauma-exposed persons.   "
246492|NCT01090336|"     Background: Both prasugrel and clopidogrel are prescribed drugs which compete as platelet     inhibitors in patients with acute coronary syndrome (ACS). Whether rates of drug     resistance/hyporesponsiveness are lower with prasugrel and whether more consistent and     earlier onset of platelet inhibition may reduce infarct size in patients with ACS undergoing     early PCI remains, at present, unknown.      Study design/study population: This trial is a prospective, open-label, single centre     observational trial. Patients receive either prasugrel (60mg) or clopidogrel (600mg) at the     discretion of the attending cardiologist. Patients with exclusion criteria for prasugrel will     be excluded for clopidogrel as well. The study population includes 80 subjects with moderate     to high-risk ACS, ie patients with unstable angina (UA) and non-ST-segment elevation MI     (NSTEMI) and TIMI risk score of 3 or higher, within 72 hours after onset of symptoms. In all     patients early PCI is planned.      Study objective/endpoint/methods: The primary objective of this trial is to evaluate whether     rates of hyporesponsiveness are lower with prasugrel and whether more consistent and earlier     onset of platelet inhibition may reduce infarct size in ACS in patients undergoing early PCI.      The primary endpoint is the rate of drug resistance at time of index intervention. Optical     and impedance aggregometry using ADP (5 and 20 μM) and collagen (1 μg/ml) as platelet     agonists is used to measure platelet aggregation. Addition of the specific antagonists     aspirin and mesamp to the probe is used to discriminate between pharmacodynamic and     pharmacokinetic drug resistance.      Secondary endpoint is the reduction of myocardial infarct size determined by     post-interventional increase of high sensitive TnT (TnT hs) during the days following the     index event reflecting earlier, more effective and more consistent inhibition of platelet     function.      Tertiary endpoint is the composite clinical endpoint of cardiovascular death, nonfatal MI, or     stroke and urgent target vessel revascularization during hospitalization and after 6 and 12     months.      Safety endpoint is any TIMI major or minor bleeding during hospital stay and after 6 and 12     months including intracranial and life-threatening bleeding.   "
246493|NCT01090349|"     St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment     or replace routine scheduled in-clinic visits.      This investigation is designed with the hypothesis that detection of events (system integrity     and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an     earlier opportunity to address and resolve events and may therefore improve patient care.   "
246494|NCT01090362|"     The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is     a pioneering real-world prospective registry - one of the largest in the field of     non-valvular atrial fibrillation (AF). With an eventual enrolment target of 55,000 patients,     GARFIELD-AF aims to enhance understanding of stroke prevention in patients with non-valvular     AF worldwide and help in defining future treatment strategies that may eventually influence     patient outcomes.   "
246495|NCT01090375|"     In the present study the microdialysis method is used to investigate biochemical changes     within and around the joint simultaneously in both the resting state and in a joint that had     been subjected to exercise. The aim of the present study was, by applying the microdialysis     technique, to monitor markers of cartilage breakdown and inflammation in 2 different     positions of the knee (inside and in the inner part of the knee capsule) in a group of human     females with knee osteoarthritis over a period of 3 hours.   "
246496|NCT01090388|"     The purpose of this study is to identify aspects of the bladder cancer (BlCa) survivorship     experience that differ by clinical risk at diagnosis. The investigators will collect     cross-sectional data from persons with BlCa to identify aspects of health-related quality of     life (HRQOL) and symptom management. The study originally enrolled only nonmuscle-invasive     bladder cancer survivors but has been expanded to include survivors with any stage disease.     Information from this study will be used to develop a new patient education and counseling     intervention.   "
246497|NCT01090401|"     The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD     lead.   "
246498|NCT01090414|"     This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with     hematologic malignancies who complete other idelalisib studies. It provides the opportunity     for patients to continue treatment as long as the patient is deriving clinical benefit.     Patients will be followed according to the standard of care as appropriate for their type of     cancer. The dose of idelalisib will generally be the same as the dose that was administered     at the end of the prior study, but may be titrated up to improve clinical response or down     for toxicity. Patients will be withdrawn from the study if they develop progressive disease,     unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in     the opinion of the investigator.   "
246499|NCT01090427|"     This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients     with moderate to severe psoriasis.   "
246500|NCT01090440|"     GSK1144814 is a potent, insurmountable antagonist at human neurokinin-1 (NK1) and     neurokinin-3 (NK3) receptors with the potential to treat multiple symptom domains of     schizophrenia and be an efficacious antidepressant.      This study will be an open label, randomised, three-way cross-over study to evaluate the     safety, tolerability and pharmacokinetics of a new tablet formulation of GSK1144814 and to     evaluate the effect of food on single oral doses of GSK1144814 in healthy male and female     subjects.   "
246501|NCT01090453|"     This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine     co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4     months of age.   "
246502|NCT01090466|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Temsirolimus may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and cisplatin     together with temsirolimus may kill more tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus     given together with gemcitabine hydrochloride and cisplatin as first-line therapy in treating     patients with locally advanced and/or metastatic transitional cell cancer of the urothelium.   "
246503|NCT01090479|"     We intend to determine how effective the use of a 2% Chlorhexidine Cloth is in terms of     eliminating the bacterial load on patients undergoing shoulder surgery. We will be comparing     the Chlorhexidine Cloths with a control group which will be performing an ordinary shower     prior to surgery. At this time, it is standard of care to only take an ordinary shower the     evening prior, and the morning of surgery.   "
246504|NCT01090492|"     The investigators propose that once daily administration of PF-00489791, a phosphodiesterase     inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and     Secondary Raynaud's Phenomenon.   "
246505|NCT01090505|"     The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant     chemotherapy may improve survival benefit compared with control.   "
246539|NCT01090947|"     The purpose of the study is to optimize an already existing algorithm for diagnosing     atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).   "
246509|NCT01090557|"     The fraction of exhaled nitric oxide (feNO) in expired air is a reliable measure of airway     inflammation. Some research experiments have demonstrated stimulation of nitric oxide     production in respiratory epithelial cells infected with RSV.      The principal aims are to determine if the fraction of exhaled nitric oxide (feNO) is     elevated in hospitalized pediatric patients with viral lower respiratory illness and to     determine if there is a difference in feNO level between RSV and non-RSV infection.      NO may play a role in the association between RSV, airway reactivity, and airway     inflammation.      This is a prospective, pilot study that will noninvasively measure feNO in children 0-4 years     of age admitted to Winthrop University Hospital, as well as controls (children in the same     age range without respiratory conditions and who are well enough to perform the test).     Hospitalized children will be tested for RSV (enzyme immunoassay (EIA) & DFA) and via direct     fluorescent antigen technique (DFA) for influenza A & B, parainfluenza, human metapneumovirus     and adenovirus.      Method of feNO measurement will utilize the offline options for preschool children & infants     appropriate for age as described in the 2005 Joint Statement of the American Thoracic Society     & the European Respiratory Society when discussing tidal breathing techniques with     uncontrolled flow rate Offline exhaled air can be collected via a mouthpiece or a face mask     connected to a non-re-breathing valve that allows inspiration of NO-free air from an NO-inert     reservoir to avoid contamination by ambient NO. Exhaled breath samples are collected into an     NO-inert bag fitted with the expiratory port once a stable breathing pattern is present.      The results of all 3 groups will be compared: control, RSV positive and RSV negative samples.   "
246510|NCT01090570|"     PLX3397 is a selective inhibitor of Fms and Kit activity. The objective of this study is to     evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction     (DDI) of orally administered PLX3397 during 2 weeks of dosing in patients with rheumatoid     arthritis (RA) who are on maintenance methotrexate. This study is planned to provide data to     inform dose selection for a subsequent 12 week dose ranging study in RA.   "
246511|NCT01090583|"     Preterm birth (birth before 37 weeks gestation) is a large problem in the United States and     is a major cause of neonatal morbidity and mortality and childhood neurological disability.     Despite significant advances in the care of pregnant mothers, the incidence of preterm labor     is on the rise. There is growing recognition that cytokines and inflammatory mediators     present at amniotic fluid and placenta play a fundamental role in regulating labor.      Cytokines are chemicals in the fluid that tell the body's immune system what to do. These     (and other biomarkers) can be measured with a small amount (a few drops) of amniotic fluid.     The researchers have previously shown that people at risk for preterm labor have higher     cytokine levels. However, understanding the in-utero environment currently requires invasive     sampling, such as amniocentesis, to determine cytokine concentrations. This procedure has     inherent risks, causes patient discomfort and anxiety, and thus does not avail itself to     routine use or repeated sampling, especially in non-high risk patients. Therefore, the     researchers are looking for non-invasive sampling that can predict the in-utero environment.      To date, no studies have simultaneously evaluated different maternal-fetal compartments to     determine the relationship of these markers among the compartments. Therefore, the purpose of     this pilot study is to determine the differential expression of inflammatory mediators in     various maternal-fetal compartments; specifically, vaginal fluid, cervical secretions,     placenta, cord blood (arterial and venous), amniotic fluid, maternal serum, maternal urine,     and maternal saliva.      The researchers seek to obtain fluid samples from nine maternal-fetal compartments and     determine the inflammatory mediator expression in each. The timing of collection, location,     and proposed studies for each of the samples is outlined in Table 1. In this pilot study, we     plan to enroll 20 patients undergoing cesarean delivery.      After consent, the samples will be collected and given a unique Study ID number. No protected     health information will be collected. In addition, there will be no link between the Study ID     and patient identifiers. Therefore, we are not seeking HIPAA authorization at the time of     consent. While none of these samples would routinely be collected as part of the standard of     care, the collection procedures meet the criteria for minimal risk.   "
246512|NCT01090596|"     Using tissue samples obtained from a previous study, the effect of naproxen on the gene     expression profiles of antral mucosal tissue will be assessed. We hypothesize that there will     be distinct changes in the gene expression profiles of samples taken from individuals treated     with naproxen versus samples taken from individuals treated with placebo.   "
246513|NCT01090609|"     The objective this study is evaluate the performance and safety of Chronus® cobalt-chromium     coronary stent in patients with de novo native coronary artery lesions treated with     19-mm-long stents in long-term 9 months.   "
246514|NCT01090622|"     The purpose of this study is to determine whether XPF-001 is safe and effective in the     treatment of pain caused by Inherited Erythromelalgia (IEM).   "
246515|NCT01090635|"     The purpose of this study is to investigate the performance ability of the UltraSightHD™. The     instrument will be assessed on characteristics such as focus quality, ability to image the     entire cervix, and illumination. The information gathered from this study will provide data     that will be used to determine which settings provide the best imaging outcome for the cervix     for a simple screening instrument. Further, this information will serve as the foundation in     the development of more advanced follow-on imaging devices.      The primary objectives of this study are to:        -  Determine if the light source provides sufficient illumination of the cervix.        -  Assess focus and overall image quality.        -  Assess the functionality and ergonomics of the instrument's design.   "
246516|NCT01090648|"     This trial is designed to assess the swallowability of uncoated and film-coated 200 mg     etravirine tablets in HIV-1 infected patients. In addition, comparisons between a single 200     mg tablet versus two 100 mg formulations will be made. The outcome of the trial will aid in     making decisions about the future commercial 200 mg formulation.   "
246517|NCT01090661|"     To assess the electrocardiogram (ECG) effects of mipomersen administered as a 200-mg     subcutaneous (SC) therapeutic and a 200-mg intravenous (IV; [2-hour infusion])     supra-therapeutic dose relative to placebo in healthy adult male and female subjects; and to     evaluate the safety and pharmacokinetics (PK) of mipomersen when administered as a single     therapeutic (200 mg) SC and a single, supra-therapeutic (200 mg) IV dose.   "
246747|NCT01081392|"     The purpose of the study is to measure inflammatory biomarkers in sputum and peripheral blood     in healthy volunteers after inhalation of single doses of LPS (20 mcg) administered as     particles of different sizes.   "
246552|NCT01076738|"     Primary Objective:      To investigate the value of the Edinburgh Claudication Questionnaire (ECQ) against the     ankle-brachial index (ABI) in Canadian patients mainly followed in general practice, with     documented acute coronary syndrome (ACS)/ischemic stroke (IS)/transient ischemic attack (TIA)     and who are not known to have peripheral arterial disease (PAD) at the time of enrolment.      Secondary Objective:      To collect data on the prevalence of PAD in this population as measured by ABI.   "
247709|NCT01091935|"     The purpose of this study is to prospectively determine the side effects profile in adults     with neuropathic pain receiving intravenous infusions of lidocaine 5 mg per kg of lean body     weight, infused over 45 minutes.   "
246518|NCT01090674|"     It is very important monitoring respiratory muscle function in patients with amyotrophic     lateral sclerosis (ALS). We have at our disposal Respiratory Functional Tests (forced vital     capacity (FVC), maximal mouth-inspiratory force (MIF), maximal mouth-expiratory force (MEF),     Cough Peak expiratory flow (cPEF), maximal voluntary ventilation (MVV), arterial blood gases     and nocturnal pulsioxymetry) and Thoracic Image Techniques (inspiratory/expiratory Thorax     x-ray and x-ray scope). But all this explorations present some technique limitations. They     are two new methods to explore diaphragmatic function: SNIF test and Diaphragm magnetic     resonance imaging (dMRI). SNIF test is simple and easy to be done and it can avoid some     problems that have the other respiratory functional test in this kind of patients. dMRI seems     to correlate with respiratory functional test and it can be useful monitoring diaphragmatic     mobility. The objective of our study is to compare and to correlate SNIF test and dMRI with     x-ray techniques and respiratory functional tests that measure diaphragmatic force and     function. First of all we will study 10 healthy people with a forced spirometry, MIF, MEF and     dMRI, trying to obtain diaphragmatic mobility reference values with dMRI. Lately, we will     study patients with ALS. In the first place, we will perform a transversal study with 30     patients. We will do a forced spirometry, MIF, MEF, MVV, cPEF, SNIF, arterial blood gases and     nocturnal pulsioxymetry, forced Inspiratory and expiratory Thorax x-ray, diaphragmatic x-ray     scope and dMRI. Secondly, we will perform a prospective study, where we will analyze these     variables evolution at 3 and 6 months. We hope we can apply the two new techniques in the     future because we think they are simpler, more accurate and more objective to evaluate     diaphragmatic mobility.   "
246519|NCT01090687|"     The primary aim of this pilot study is to define the role of dedicated cone beam breast     computed tomography in breast cancer imaging. This research is a prelude of a more     comprehensive clinical trial that may follow.   "
246520|NCT01090700|"     The purpose of this study is to investigate the effect of steady-state concentrations of     TMC435 150mg q.d. (once a day) on the steady-state pharmacokinetics of escitalopram 10 mg     q.d., and vice versa. Steady state is a term which means that the drug has been given long     enough so that the plasma concentrations will remain the same with each subsequent dose.     TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection.     Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the     body and eliminated from the body.   "
246521|NCT01090713|"     The specific aim of this study is to examine the efficacy and safety of lisdexamfetamine     compared with placebo in outpatients with binge eating disorder   "
246522|NCT01090726|"     The purpose of the pilot study is to compare new laryngoscopes for infants by assessing the     equipment best suited to assist the intubation, with the best overview, shortest time to     intubation and use these numbers to make a sample size calculation for the full protocol. The     investigators hypothesis is that the Storz videolaryngoscope® has a better success rate than     infants (<2 years). The patients will be optimally anaesthetized with neuromuscular blockade     for the intubation. All patient will be evaluated with af Macintosh blade laryngoscope, with     an Airtraq® or a Storz videolaryngoscope®, and finally intubated with the other one of the     later, which the patient was randomized to.   "
246523|NCT01090739|"     The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal     incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day     bowel diary at 12 months.   "
246524|NCT01090752|"     This study examines the effects of pioglitazone on renal sodium handling in subjects prone to     insulin resistance, i.e. diabetic and/or hypertensive subjects.   "
246525|NCT01090765|"     Background:        -  Currently, there is no curative therapy for metastatic castrate-resistant prostate          cancer (CRPC), a leading cause of death in men. However, researchers are exploring new          treatments that involve drugs that prevent angiogenesis (the process by which new blood          vessels are formed) and can slow or prevent tumor growth.        -  TRC105 is an experimental drug that blocks angiogenesis, and has been studied for          possible use in treating different kinds of cancer. However, it has not been validated          to treat prostate cancer in general or CRPC in particular.      Objectives:        -  To determine the effects of TRC105 as a treatment for CRPC        -  To determine the safety and effectiveness of TRC105 in treating CRPC      Eligibility:      - Men at least 18 years of age who have been diagnosed with castrate-resistant prostate     cancer for which existing treatments have not been effective.      Design:        -  Eligible individuals will have a series of blood and other tests to determine their          suitability for participating in the study.        -  Participants will receive intravenous infusions of TRC105 in a 28-day treatment cycle.          Participants will receive i.v. (intravenous) infusions of TRC105 every two weeks on days          1 and 15 of each 28-day cycle (cohorts 1, 2, 3, 5, and 6) and every week on days 1, 8,          15, and 22 of each 28 day cycle (cohort 4).        -  Participants will receive different doses of TRC105 depending on when they enter the          study, up to a maximum tolerated dose or optimum treatment dose.        -  Frequent blood and urine tests will be performed during treatment, as well as other          tests of cancer progression as directed by the study doctors. Participants will receive          medicines to help prevent possible adverse side effects of TRC105, such as allergic          reaction to the drug.        -  Participants will continue treatment with TRC105 until they or the study team decides          that the medication is not beneficial. No additional testing will be required unless          participants discontinue the treatment because of side effects (which the study doctors          will follow until the side effects are resolved).   "
246526|NCT01090778|"     This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and     pharmacodynamic profiles of growth hormone using two different modes of growth hormone     administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the     thigh) in 8 adult male or female patients with growth hormone deficiency during interval     exercise or in supine rest. The order of dosing regimen within the groups and between the     groups will be randomised. All patients will go through four different treatment sessions:A/B     Single subcutaneous bolus injection, supine rest without/with interval exercise, sessions     C/D: Continuous subcutaneous infusion, supine rest without/with interval exercise.     Hypotheses: 1) There is day-to-day variation of exogenous growth hormone, 2)Concentration of     growth hormone decreases due to exercise compared to supine rest, 3)There is a circadian     variation in pharmacokinetics of exogenous growth hormone infused subcutaneously   "
246540|NCT01090960|"     This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and     pharmacokinetics of escalating oral doses of GDC-0068 administered to patients with     incurable, locally advanced or metastatic solid malignancy that has progressed or failed to     respond to at least one prior regimen or for which there is no standard therapy. This study     is expected to enroll approximately 39 to 57 patients at approximately two sites in Spain.   "
246541|NCT01090973|"     The purpose of the study is to find out the effects and the safety of an investigational     study drug called LBH589 when given to people with relapsed or refractory chronic lymphocytic     leukemia (CLL) or mantle cell lymphoma (MCL).   "
250403|NCT01134237|"     Intrapleural thrombolytic treatment with urokinase for retained hemothorax is effective and     safe. However, previous study was limited in prospective observation study without control     group.   "
246527|NCT01090791|"     Acute circulatory failure may be related to hypovolemia. Fluid loading increases stroke     volume in approximatively half of challenges. Determining fluid responsiveness prevents     unnecessary fluid loading. Passive leg raising (PLR) provides a transient increase of 300 ml     in venous return for a short time. The measurement of stroke volume (SV) before and after a     PLR test allows physician to detect fluid responsiveness, when stroke volume increases is     higher than 15 %. Beside thermodilution, the use of non invasive device to measure stroke     volume becomes largely employed. Arterial Pressure based Cardiac Output (APCO), provided by     the Flotrac/Vigileo system, does not required specific materials nor repeated calibration.     The third generation software is believed to be more accurate and more precise for SV     measurement. The aim of this study is to test the performance of the Flotrac/Vigileo device     in a situation of rapid venous return changes induced by PLR and then by fluid loading.     Patients will be classify posteriorly in responders and non responders, according to the     magnitude of the fluid loading-induced SV changes measured by transthoracic echocardiography.   "
246528|NCT01090804|"     The purpose of this study is to determined effects of BreatheMAX on secretion clearance.   "
246529|NCT01090817|"     Despite the advent of newer biologic therapies such as infliximab for Crohn's disease, a form     of autoimmune inflammatory bowel disease, a proportion of patients are refractory to such     therapy and require surgery. The hypothesis is that mesenchymal stromal cell therapy using     third party human cultured cells will be safe and effective   "
246530|NCT01090830|"     The purpose of this study is to establish the safest dose of the investigational medication     Belinostat that can be administered with a standard of care chemotherapy regimen of     bevacizumab, carboplatin, and paclitaxel. Further study will examine the short and long-term     effect (up to 2 years) of this medication on participant's disease status and overall     survival.   "
246531|NCT01090843|"     MiroCam® is the new video capsule endoscope of IntroMedic®. By using a novel transmission     technology it promises a longer battery life expectancy with consequential impact on the     length of the video recorded for diagnostic evaluation. As the investigators know about the     shortcoming of battery life expectancy from many capsule examinations that were inconclusive     because the ileocaecal transit was not filmed, the investigators would appreciate to have a     capsule with extended video recording to improve the diagnostic yield of capsule     examinations. Therefore the investigators want to compare MiroCam® to our routinely used     Olympus® Enteropro EndoCapsule® in the context of a half-year clinical trial. Focussing on     the total video length as well as on the rate of video-recorded ileocaecal transitions as     surrogate parameters the investigators want to find out whether one of the two products     provides superior diagnostic information in order to reduce the amount of inconclusive     examinations.   "
246532|NCT01090856|"     Percutaneous treatment of bifurcation lesion is a complex procedure. After main vessel stent     implantation, the side branch became jailed and the carina can be displaced resulting in     complete occlusion of this vessel. Re-wiring the side branch in this conditions may result     difficult and some times impossible. There is no agreement regarding the need of side branch     pre-dilation (before main vessel stent implantation) to reduce these complications.     Researchers from European Bifurcation Club have proposed no to pre-dilate the side branch to     avoid vessel dissection and difficulties in rewiring the true lumen of the vessel. On the     contrary, our group has a good experience in the treatment of bifurcation lesions treated     with side branch pre-dilation.      Aims: 1.- To determine the efficacy of the side-branch pre-dilation in patients with     bifurcations lesions treated with provisional T stenting. 2.- To determine the success rate     and incidence of complications in patients with and without side-branch pre-dilation, as well     as economic impact in terms of number of used wires.   "
246533|NCT01090869|"     The investigators aimed to evaluate the health benefits of physical training per se, weight     loss per se and exercise-induced weight loss in young, overweight men. The investigators     hypothesized that physical training would have independent effects on various health     parameters (insulin sensitivity, fasting glucose and insulin, total and abdominal fat mass,     waist circumference, blood pressure and key muscle proteins), and that a concomitant weight     loss from physical activity would increase the effect.   "
246534|NCT01090882|"     Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to     same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall     bladder decreases pain. In many patients pain has a strong component attributable to     diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide     high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise     that LA injected to the right hemidiaphragm during LC would be more effective than wash.      Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing     elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline;     Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control     'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre     recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to     eating and mobilising, day case surgery.   "
246535|NCT01090895|"     Primary Hypothesis: Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous     coronary intervention (PCI) would limit the size of the infarct, assessed by measurements of     cardiac biomarkers, during acute myocardial infarction.      Secondary Hypotheses: Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous     coronary intervention (PCI) would limit the size of the infarct, as measured by the area of     delayed hyperenhancement that was seen on cardiac magnetic resonance imaging (MRI), assessed     on day 5 after infarction, during acute myocardial infarction.   "
246536|NCT01090908|"     This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety,     and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI)     in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection.   "
246537|NCT01090921|"     This is a research study to see if a new drug called bortezomib is useful to treat multiple     myeloma in people who are newly diagnosed, and have not yet received treatment for their     disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium     Pharmaceuticals, Inc.   "
246538|NCT01090934|"     Multicenter prospective study comparing the diagnosis value of high-resolution EEG and     depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.   "
246542|NCT01090986|"     Non invasive ventilation (NIV) usually presents air leaks that may determine the result of     this treatment. The clinical usefulness of analyzing (and quantifying) these leaks during the     adaptation period to NIV has not been evaluated in prospective clinical studies as a     predictive data of treatment effectiveness. Our hypothesis is that air leaks are correlated     to a successful adaptation to NIV. And air leak magnitude may predict early failures of this     treatment. And also, as we do not know if air leaks change during the adaptation period to     NIV, we do not know whether early detection of air leaks plays a role in the therapeutic     outcome. Our objective is to evaluate the clinical usefulness of quantifying air leaks during     the adaptation period to NIV as a predictor of effectiveness of this treatment. We also want     to evaluate the correlation between air leaks and clinical-functional patients' profile, and     the ventilatory parameters selected and to evaluate air leaks variability during the     adaptation period to NIV. Method: We will determine the air leak magnitude in twenty patients     during adaptation to NIV. We will use VPAP III ventilators (ResMed, Australia), commercial     nasal masks (Mirage o Ultra Mirage) and VPAP III/ResLinkTM (ResMed, North Ryde, Australia), a     device that includes a monitoring system coupled with the VPAP III ventilator. This device     allows to record air leaks and other ventilation parameters. We will perform four VPAP     III/ResLinkTM recordings in each patient (the last night in hospital during the adaptation     period, the first night at home, and one and two months later, after the initiation of NIV     treatment). We will also perform a complete pulmonary function test, quality-of-life     questionnaire (SF36), and a tolerance to NIV questionnaire in all patients at the onset of     NIV treatment and two months later. We will evaluate which patients will need to change     treatment at the end of the adaptation period to NIV. We also will analyze and compare air     leaks magnitude in each of the four recordings stated above.   "
246543|NCT01090999|"     OBJECTIVE: To determine whether a long-term maintenance program after respiratory     rehabilitation, in contrast to the usual minimal maintenance therapy, improves the     cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity,     HRQL, and reduced exacerbations b.- reducing the total cost of care to patients, largely     through reduction of exacerbations.      MATERIAL AND METHODS: multi-center (4 hospitals) prospective randomized controlled study that     will include 150 patients with moderate-severe COPD (age <75; BODE 4-10) with a 3 years     follow-up. All patients will receive an initial in-hospital rehabilitation program which     includes: Education, Physiotherapy, lower and upper extremities training and respiratory     muscles training. Following completion of this program, patients will undergo concealed     randomization to one of two maintenance strategies:1.-an intensive maintenance program (GR1)     2.- a standard, minimal monitoring program (GR2). On the intensive maintenance program (GR1)     the physiotherapist will call once a week as a reminder and the patient will attend the     hospital once a week . A physiotherapist will supervise the weekly in-hospital exercise and     he/she will check if the patient is properly undergoing the rehabilitation treatment.      OUTCOMES: 1.- Clinical: dyspnea (area of CRQ questionnaire), HRQL (CRQ, SF 36); Effort     capacity (6minute Walking Test), BODE index; 2.- Economical: direct costs (programs);     indirect costs (exacerbations, admissions); comparison of GR1 and GR2 costs; EXPECTED     OUTCOMES: reduction of dyspnea, improvement of HRQL, effort capacity and BODE index, and     reduction of health expenditures in GR1 compared to GR2.   "
246544|NCT01091012|"     The main objective is to validate the safety and efficacy of intravenous and oral sildenafil     in the acute vasodilator test in patients with persistence of, at least, moderate pulmonary     hypertension after valvular surgery successfully, with a correct left ventricular function     and no valvular disease hemodynamically significant.   "
246545|NCT01091025|"     The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients'     survival improves. Early diagnosis of CFRD is crucial to prevent the unnecessary     deterioration of lung function and nutritional status, both of which affect the patient's     overall survival. The oral glucose tolerance test (OGGT) is the accepted method for detecting     CFRD. The Cystic Fibrosis Trust guidelines (2004) recommend that patients with CF over the     age of twelve years should be screened annually. Most hospitals use an annual OGTT.     Performing OGTT on all CF patients is inconvenient and may not be cost effective, as patients     have to starve overnight and need to spend an extra 2 hours in the hospital in addition to     all the other annual review tests. In our centre, a selective approach is used. If patients     have an abnormal random blood glucose and /or abnormal glycosylated haemoglobin (HbA1c)     and/or symptoms of hyperglycaemia or unexplained weight loss then an OGTT will be performed.      The aims of this study are        1. To compare the clinical efficiency in the screening for CFRD in the two different          methods: i)a selective approach , ii)an unselected annual OGTT for all patients.        2. To compare the cost effectiveness of the two approaches in the screening for CFRD.   "
246546|NCT01091038|"     The study will measure the effect of basic clinical decision support on medical errors and     adverse drug events in the ambulatory setting.   "
246547|NCT01091051|"     This study will provide data on sasety and efficacy of Ustekinumab in patients suffering from     Palmo-Plantar Pustular Psoriasis (PPPP) or Palmo-Plantar Pustulosis(PPP)   "
246548|NCT01091064|"     Acute viral bronchiolitis is the principal cause of lower respiratory tract infection in     infants worldwide. It is characterized by a first episode of respiratory distress preceded by     rhinorrhea, cough and fever. The majority of patients present with mild symptoms which can be     treated safely at home by parents. Every year between October thru April emergency     departments in North America are overwhelmed with patients waiting to be seen with mild     respiratory infections, such as bronchiolitis. Thus new strategies in health care have to be     elaborated to reduce costs and waiting time in the emergency department.      The investigators hypothesize that patients liberated from triage with mild acute viral     bronchiolitis would have the same rate of office re-visits than those with mild acute     bronchiolitis in the emergency department.   "
246549|NCT01091077|"     Hepatitis C virus when it leaves the cells in the liver is bound to a type of fat. An     component of grapefruit could block this fat and thus lower the amount of virus in the blood     stream. We propose that treatment with this ingredient, called naringenin, could be used to     block this fat and HCV in persons infected with hepatitis C.   "
246550|NCT01076712|"     Parkinson's Disease is an incurable and progressive disease. Treatment includes medication     and non-pharmacological intervention such as physiotherapy. Physiotherapy is a main component     of non-pharmacological interventions. It includes exercise to strengthen the muscles;     improves balance and walking, and adopts the use of visual cue training. Treatment has been     found to be effective in patients with mild impairment up to 6 months post-treatment. The     present study will investigate the effectiveness of treatment for patients with mild to     moderate impairment for short term (3-month) and long term (1 year). The hypothesis is that     compared to patient education alone, physiotherapy intervention for patients with Parkinson's     disease leads to improve function and quality of life.   "
246551|NCT01076725|"     Insertion of the ProSeal laryngeal mask airway in pediatric patients using the 90 degree     rotational technique is more successful and causes less pharyngeal trauma than the standard     technique in pediatric patients.   "
246553|NCT01076751|"     Primary Objective:        -  Describe real-life survival of CRPC patients who received first-line docetaxel and have          disease progression      Secondary Objective:        -  Describe treatment patterns        -  Describe the characteristics and outcomes of patients who received second-line          taxane-based treatment compared to others        -  Describe economic and patient-reported outcomes   "
246554|NCT01076764|"     Primary Objective:        -  To demonstrate the superior efficacy (composite of all-cause death + Myocardial          Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide      Secondary Objectives:        -  To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of          Otamixaban as compared to UFH + Eptifibatide        -  To document the effect of Otamixaban on rehospitalization or prolongation of          hospitalization due to a new episode of myocardial ischemia/myocardial infarction as          compared to UFH + eptifibatide        -  To document the effect on mortality (all cause death) of Otamixaban as compared to UFH +          eptifibatide        -  To document the safety of Otamixaban as compared to UFH + eptifibatide        -  To document the effect of Otamixaban on thrombotic procedural complications during the          index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide   "
246555|NCT01076777|"     The purpose of this study is to compare manualised physical exercise conducted in groups to     manualised cognitive-behavioral therapy conducted in groups as treatment for panic disorder     with or without agoraphobia.   "
246556|NCT01076790|"     Dexmedetomidine acts at central nervous system (specifically: at locus caeruleus), providing     sedative and analgesic effects. It is widely used in intensive care. Surgery-related     interventions elicit arousal ('nociceptive') reactions. The effects of dexmedetomidine on the     neurophysiological signs of arousal are studied in surgical patients. Brain waves,     electrocardiogram, Entropy Index, Bispectral Index, and fingertip pulse waves are recorded     and analyzed later on. The course of anaesthesia and surgery are recorded.   "
246557|NCT01076803|"     The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the     relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This     effect will be evaluated by the percentage of responder patients 7 and 14 days after one     administration of lanreotide 120 mg.      (A responder patient will be defined either as a patient experiencing < or= 1 vomiting     episode per day during at least three consecutive days or as a patient in whom NGT has been     removed without any vomiting recurrence during at least three consecutive days)      The total number of visits will depend on the clinical situation, 5 visits are obligatory:     Day(D)-3/-0,Day 1,Day 7,Day 14,Day 28      Inclusion visit (D-3/-0): eligibility, PIC, obstruction history, clinical exam, vital signs,     diary cards, VAS scale, cc medication, blood sample      Visit D1: injection Visit D7/D14/28: clinical exam, nutrition procedure, result of     biochemical analyse, adverse events, cc medication      In between the visits, the patient will keep and fill out his diary and VAS scale   "
246558|NCT01076816|"     Currently, dexmedetomidine is approved by the United States Food and Drug Administration     (FDA) for short-term analgosedation (<24h) in mechanically-ventilated critical care adult     patients and sedation of non-intubated adult patients prior to and/or during surgical and     other procedures. Trials are underway to investigate its pharmacokinetics, clinical efficacy     and safety in long-term use. Clinical experience with dexmedetomidine in the paediatric     population is limited. Moreover, during childhood many developmental changes take place with     consequences on drug exposure and drug response. Finally, critical illness itself can affect     drug pharmacokinetics and -dynamics. Therefore, we cannot simply extrapolate adult data for     use in children but we are in need of data on pharmacokinetics and pharmacodynamics in every     paediatric subpopulation.   "
246559|NCT01076829|"     Polyphenols belong to the largest group of secondary metabolites produced by plants, mainly,     in response to biotic or abiotic stresses such as infections, wounding, UV irradiation,     exposure to ozone, pollutants, and other hostile environmental conditions. It is thought that     the molecular basis for the protective action of polyphenols in plants is their antioxidant     and free radical scavenging properties. These numerous phenolic compounds are major     biologically active components of spices, aromas, essential oils, and traditional medicines.     In order to investigate the impact of spice polyphenols on postprandial flow-mediated     dilation, nitric oxide, glucose, insulin, triglycerieds, oxidized LDL, and cytoxic lipid     peroxidation products (MDA) levels in men with type 2 diabetes, the investigators propose to     achieve the following specific aims using a randomized crossover study design:        1. To determine the effect of a ground beef patty meal with and without polyphenol-rich          spices on postprandial levels of plasma oxidized LDL, triglycerides, insulin, glucose,          and malondialdehyde (MDA).        2. To determine the effect of a ground beef patty meal with and without polyphenol-rich          spices on postprandial levels of nitric oxide and flow-mediated dilation.        3. To determine the effect of a ground beef patty meal with and without a spice blend on          MDA accumulation in urine.      This study will determine whether spice polyphenols exert a beneficial effect by inhibition     of the absorption of lipotoxin MDA in males with type 2 diabetes mellitus.Men with diabetes     mellitus type 2 have been selected for this study to enable assessment of markers of vascular     health including nitric oxide in plasma and flow-mediated dilation. These findings may help     to explain the potentially harmful effects of oxidizable fats found in foods and the     important benefit of dietary polyphenols in ameliorating this potentially harmful effect.   "
246560|NCT01076842|"     The purpose of this study is to compare the effectiveness of two different kinds of diabetes     medications, insulin detemir (Levemir) and exenatide (Byetta), in improving blood sugar     levels with little or no weight gain in patients with type 2 diabetes who are not well     controlled on two or more oral (by mouth) diabetes medications. Both medications are given by     injection with a very small needle just below the surface of your skin (called subcutaneous     injection). The medication that you inject will be in addition to your oral medications.   "
246561|NCT01076855|"     The purpose of the programme is to facilitate the anticipation of dementia both in elderly     patients suffering from this disease and in their carers and to diminish care burden in order     to improve quality of life and daily functioning.   "
246574|NCT01079104|"     Patients with hepatic dysfunction are known to have a high mortality rate. Hepa Wash(R) is a     newly developed liver and renal support system that is based on the use of recycled albumin     dialysate. The new system has shown a high detoxification capacity in in-vitro and     preclinical studies. The aim of the study is to evaluate the safety and efficacy of the Hepa     Wash system in patients with hepatic dysfunction in the intensive care unit.   "
246677|NCT01080469|"     The objective of the study is to demonstrate bioequivalence between Test Product (A):     Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding     Reference Product (B): Prograf (Tacrolimus) Capsules 1 mg, manufactured by Astellas Pharma,     Inc., USA in 36 normal, healthy, adult, male subjects under fed condition.   "
249423|NCT01120782|"     The purpose of this study is to determine whether the prescription determined for a new daily     disposable toric contact lens will be a good match to a prescription determined for an     existing brand of lens.   "
246562|NCT01076868|"     This is a continuous cohort study consisting of 200 participants (one third 6 months old to 5     years, one third 6 to 15 years old, one third ≥ 15 years old) i.e. a new patient will be     recruited (from the same age group) for any patient who develops a Pv infection so that the     cohort will always have 200 patients for 3 years. Each patient will be actively followed-up     every 8 weeks until Plasmodium vivax infection occurs but the duration of follow up and the     number of follow up visits for each patient will vary depending on when or if a vivax     infection occurs and when the patient is recruited. Therefore, the minimum follow up period     for each patient will be 6 months or time to vivax infection and the maximum will be 3 years     if a patient does not get vivax infection and is recruited at the beginning of the study.   "
246563|NCT01076881|"     This is a randomized trial with participants recruited from one dialysis unit of a Brazilian     university hospital. Hemodialysis patients were assigned to receive the resistance exercise     combined with an aerobic training or the resistance training alone for a period of 10 weeks.     The functional performance of patients was assessed before and after the intervention through     the six-minute walk test (6MWT). The difference over time of the 6MWT was compared between     the groups through multivariate linear regression.      Thirteen patients were allocated for each group of intervention. The difference in distance     walked before and after intervention in the combined training group was of +39.7 (61.4)     meters, and this difference in the resistance training group was of -19.2 (53.9) meters,     p=0.01. In multivariate analysis with adjustment for age, skin color, gender, hematocrit,     time since starting dialysis, Kt/V and baseline values of 6MWT, the type of training remained     significantly associated with the amount of increase in walked distance.      Although the best protocol of exercise for patients on dialysis is not yet clear, in the     investigators sample of hemodialysis patients the combination of aerobic and resistance     training was more effective to improve functional performance.   "
246564|NCT01076894|"     Postoperative pain and consecutive reduction of pulmonary function after thoracic surgery     still is a major clinical problem and challenge in anesthesia. Thoracic epidural anesthesia     is commonly considered to be the gold standard for postoperative pain control and     restoration of pulmonary function after thoracic surgery.      Thus, the aim of the present study is to investigate whether an intercostal nerve block with     ropivacaine plus intravenous PCA with morphine is as effective as thoracic epidural     anesthesia with respect to postoperative pain control and pulmonary   "
246565|NCT01076907|"     Hypotheses        1. Loading the sigmoid colon with warm water and warm water irrigation for dealing with          spasm (Study Treatment) will significantly reduce the proportion of patients complaining          of abdominal discomfort compared with no water loading and waiting for spasms to subside          (Control Treatment). The median discomfort score reported by the patients will be          significantly lower in the group receiving the Study Treatment than the group receiving          Control Treatment. Hypothesis        2. Exploratory hypothesis: There are differences in secondary outcome variables when          patients managed by the Study and Control Treatments are compared. Co-variables affect          the primary and secondary outcome variables.   "
246566|NCT01076920|"     Ischemic cardiomyopathies are a leading cause of death in both men and women. When a person     has a heart attack, blood is unable to reach a certain area of the heart, and if the blood     supply is not re-established quickly, that area of the heart can suffer permanent damage.     While recovery from a heart attack can be managed through medications and lifestyle changes,     these treatments can not reverse the all damage to the heart. Current research is focusing on     the development of cell-based therapies using stem cells to repair organs that have been     irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem     cells (MSCs), has shown promise for heart repair. This study will evaluate the safety of     injecting MSCs directly into the heart to repair and restore heart function in people who     have had a heart attack and who have chronic myocardial ischemia with heart failure.   "
246567|NCT01079000|"     The purpose of this study is to determine if evidence-based guidance on follow-up care and     self-management provided to PCPs and patients, respectively, reduces relapses within 90 days     for acute asthma (primary outcome). Secondary outcomes will include follow-up visits with the     primary care provider, patients' quality of life and cost-effectiveness indicators.   "
246568|NCT01079013|"     The study hypotheses is that the introduction of dose escalated treosulfan, in substitution     to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while     improving disease eradication in patients with lymphoid malignancies not eligible for     standard transplantation.   "
246569|NCT01079026|"     prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for     radiculopathy with HNP   "
246570|NCT01079052|"     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP     20 mg manufactured by OHM Laboratories with Pepcid® AC Acid reducer famotidine tablets 20 mg     (containing famotidine 20 mg) distributed by Johnson & Johnson. Merck Consumer Pharmaceutical     Co. Fort Washington, PA 19034 USA under fed conditions.   "
246571|NCT01079065|"     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP     20 mg manufactured by OHM Laboratories with Pepcid® AC Acid reducer famotidine tablets 20 mg     (containing famotidine 20 mg) distributed by Johnson & Johnson. Merck Consumer Pharmaceutical     Co. Fort Washington, PA 19034 USA under fasting conditions.   "
246572|NCT01079078|"     The study was conducted as an open label, balanced, randomised, two-treatment, two-period,     two-sequence, single dose, crossover bioavailability study comparing acetaminophen extended     release gelcaps 650 mg (containing acetaminophen 650 mg) of OHM Laboratories Inc. with     TYLENOLÒ arthritis pain caplets 650 mg (containing acetaminophen 650 mg) of McNeil Consumer &     specialty Pharmaceuticals in healthy, adult, human, male subjects under fed condition.   "
246573|NCT01079091|"     Patients with compensated chronic liver disease who have an episode of acute deterioration of     liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate.     Hepa Wash(R) is a newly developed liver and renal support system that is based on the use of     recycled albumin dialysate. The new system has shown a high detoxification capacity in     in-vitro and preclinical studies. The aim of the study is to evaluate the safety and efficacy     of the Hepa Wash system in patients with acute-on-chronic liver failure in the intensive care     unit.   "
246577|NCT01079143|"     Recently, early biomarkers of renal interstitial fibrosis have been identified, amongst them     de novo expression of vimentin by tubular epithelial cells, which is an intermediate     filament, and the translocation of beta-catenin into their cytoplasm. These markers, when     present, suggest that the epithelial cell undergoes a phenomenon well known as epithelial to     mesenchymal transition (EMT) and could behaves like a myo-fibroblast. EMT is highly     instrumental in several models of tissue fibrosis, including in the kidney. Actually, it has     not only been demonstrated that these markers are detectable in the renal graft at an early     time point post-transplant (i.e. as soon as three months), but also that the intensity of     their expression correlates with the progression of interstitial fibrosis of the graft     between 3 and 12 months   "
246578|NCT01079169|"     The purpose of this study is to establish whether cranberry capsules reduce rates of urinary     tract infections during initial rehabilitation immediately after spinal cord injury.   "
246579|NCT01079182|"     The research question explored in this study was whether the effectiveness and safety of     adalimumab in participants with ankylosing spondylitis was maintained during long-term     therapy in routine clinical practice in Germany.   "
246580|NCT01079195|"     The aim of this post-marketing observational study (PMOS) is to provide data on the     effectiveness and tolerability of Tarka in patients with a high risk of developing diabetes     mellitus, as prescribed by the physicians in a community setting and in accordance with the     terms of the local marketing authorization. The following specific questions will be     addressed:        -  Effectiveness of Tarka in lowering the blood pressure in hypertensive patients being at          high risk of developing diabetes, not controlled on single-drug therapy.        -  Tolerability of Tarka as assessed by withdrawal rates.   "
246581|NCT01079208|"     The purpose of this study is to assess the growth of infants fed a novel starter formula     containing synbiotics and different protein levels, compared to a standard starter infant     formula, during the first four months of life.   "
246582|NCT01079221|"     COPD patients have a reduced exercise tolerance due to a ventilatory limitation.      Several studies have shown altered skeletal muscle function. The investigator will study the     physiological response to knee-extensor exercise in COPD patients.   "
246583|NCT01079234|"     This trial is conducted in Europe and in the United States of America (USA). The aim of this     trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with     type 1 diabetes.   "
246584|NCT01079247|"     The purpose of this study is to find out if burn injured patients do better receiving fewer     blood transfusions than what is traditionally given. We traditionally provide blood     transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood     cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter     and is the standard measurement used to indicate the level of red blood cells in your blood).     However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8     g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above,     would reduce the occurrence of blood infection, duration on the respirator and length of     hospital stay, yet would achieve similar survival in both groups.   "
246585|NCT01079260|"     This study aims to investigate the efficacy of high energy, low volume oral nutritional     supplements (ONS) compared to equivalent standard ONS (control) to maximize nutrient intake,     compliance, gastro intestinal tolerance and function, in participants at risk of     malnutrition.   "
246586|NCT01079273|"     The purpose of this study is explore the antibody and cell mediated immune responses to one     injection of Focetria™ pandemic influenza vaccine in healthy adults aged 18-60 years.   "
246587|NCT01079286|"     In the present study the investigators want to explore the safety, pharmacokinetics, and     activity of the combination of temsirolimus and nelfinavir, both agents with PI3K /Akt/mTOR     inhibiting activity, in patients with advanced malignancies.Temsirolimus has proven anti     tumoral activity by mTOR inhibition. Nelfinavir is a potential inhibitor of Akt. Combining     both agents might prevent upregulation of the P13k pathway and increase the anti-cancer     activity of temsirolimus. The strong CYP3A4 inhibition of nelfinavir and the dependence of     temsirolimus on CYP3 A4 metabolism makes a dose finding study essential. The investigators     will also look at the prospective value of biomarkers of activity and the outcome of the     treatment.   "
246588|NCT01079299|"     This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the     effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous     ulcers in subjects diagnosed with chronic secondary lymphedema. Time to complete healing,     healing rates, edema, wound pain, granulation tissue, and wound exudate (type and amount)     will be compared between the IPC-treated group (IPC plus standard compression)and control     (standard compression alone).   "
246589|NCT01079312|"     Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde     cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality.     Delivery of propofol and short-acting potent opioid analgesic using a self-administration     device (patient-controlled sedation, PCS) could be another option for this purpose.     Comparative studies with PCS for ERCP are lacking.The main objective of this prospective     randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist     managed propofol sedation during ERCP.   "
246590|NCT01079325|"     The purpose of the study is to evaluate the clinical effects of the investigational drug,     SB-509, in subjects with diabetic neuropathy.   "
246591|NCT01079338|"     This study aims to establish whether the protein composition of healthy males contribute to     their sensitivity to the bitterness of caffeine.   "
246592|NCT01079351|"     The purpose of this study is to assess the safety, tolerability and steady-state     pharmacokinetics of intravenous (IV) Carbamazepine (CBZ) infusions relative to orally     administered CBZ in adult patients with epilepsy.   "
246649|NCT01080105|"     This study will develop and evaluate the effectiveness of a technology-assisted behavioral     intervention, consisting of Internet-based cognitive behavioral therapy combined with     telephone and email support, in preventing depressive symptoms and improving treatment     adherence in individuals at risk of major depressive disorder.   "
246650|NCT01080118|"     The use of the video laryngoscope to teach laryngoscopy will improve the performance of     tracheal intubation done by novices because it will allow a shared view of the airway leading     to a better feedback from the trainer to the trainee.   "
246593|NCT01079364|"     Primary Objective:      To demonstrate non-inferiority of once daily injection of insulin glargine (Lantus) plus one     injection of mealtime insulin glulisine (Apidra) at the main meal versus twice daily premixed     insulin (NovoMix 30/70) based on the reduction of HbA1c percentage from baseline to endpoint.      Secondary Objective:        -  To determine treatment satisfaction (DTSQs/Diabetes Treatment Questionnaire - Status,          DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment Satisfaction          Questionnaire)        -  To determine the mean HbA1c, FBG (Fasting Blood Glucose), prandial BG (Blood Glucose)          and proportion of patients with a HbA1c <7%        -  To determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight          gain and injection site reactions)        -  To determine the total insulin dose, average insulin glargine, insulin glulisine and          premixed insulin dosages.   "
246594|NCT01079377|"     This study will examine the interaction of psychological factors and serious overweight to     determine if particular patterns of psychological symptoms are helpful in predicting outcomes     of weight loss surgery.      Patients from the Center of Adolescent Bariatric Surgery (CABS) program at the Morgan Stanley     Children's Hospital of New York Presbyterian will be asked to participate in a longitudinal     prospective study of psychopathology among severely obese adolescents. Additionally, the     psychological symptoms of this group will be compared to other treatment-seeking obese     adolescents.      The investigators hypothesize that:        1. Adolescents receiving bariatric surgery will demonstrate significant reductions in body          weight, eating pathology, and other symptoms after receiving bariatric surgery.        2. Adolescents enrolled in the bariatric surgery program will report more psychological          problems than other treatment-seeking obese adolescents.   "
246595|NCT01079390|"     In this proposal, we plan to dynamically investigate brain response to verum acupuncture (of     two different doses) and placebo acupuncture, using a paradigm that approximates clinical     acupuncture practice across multiple treatment sessions in knee osteoarthritis (OA) patients.     This proposal aims to: 1) characterize session-to-session brain responses to verum / sham     acupuncture treatment (reliability of response) for OA patients, and 2) investigate how     different doses of acupuncture influence brain response and acupuncture efficacy (impact of     dose). The findings of this project will deepen our biological understanding on why and how     acupuncture can treat chronic pain and what happens in the brain during the multiple-session     acupuncture treatment.   "
246596|NCT01079416|"     Esophageal capsule endoscopy is sedation-less alternative to upper endoscopy for evaluating     esophageal lesions and potentially other upper gastrointestinal lesions. The purpose of this     study was to determine whether esophageal capsule endoscopy is convenient and accurate as     upper endoscopy for detection of esophageal varices and related lesions.   "
246597|NCT01079429|"     The purpose of this study is to describe DNA copy number variations and gene expression     profiles of bone marrow plasma cells of monoclonal gammopathy of undetermined significance     (MGUS) and smoldering multiple myeloma (SMM). The final objective is to search for     correlations with the risk of progression in order to establish a predictive model of early     malignant transformation.   "
246598|NCT01079442|"     The purpose of the investigators study is to investigate the effects of coffee on the return     of bowel function and appetite, length of hospital stay, and complications after elective     open colectomy in a prospective randomized trial. The primary efficacy endpoint is time to     first bowel movement.   "
246599|NCT01079455|"     Abstract Background: The effect of intra-articular treatment of hip osteoarthritis with     hyaluronic acid in the hip joint is not based on large randomized controlled trials.     Hyaluronic acid is a well established treatment for osteoarthritis of the knee.      Methods: Randomized controlled trial with three-armed parallel-group design. The patients     meeting the inclusion criteria will be randomized into one of the following groups:     infiltration of the hip joint with hyaluronic acid, with corticosteroids or with bupivacaine     0,125%.      Pain VAS, Harris Hip Score and HOOS were scored during follow-up. The patients will be asked     to determine their situation as worse, stabile or better then at the time of enrollment.     There will be asked if they use painkillers and if they have complications/adverse events.     These outcome measure instruments will be used at the time of enrollment in the study prior     to any injection, and then again at six weeks, 3 and 6 months after the initial injection.     The six-month follow-up period begins for all patients on the date the first injection will     be administered.   "
246600|NCT01079468|"     Transient cognitive changes after surgery may be due to many different factors. It is     estimated that between 5-29% of patients undergoing orthopedic surgery experience a transient     decline in their cognition. Fat and bone marrow debris embolization can cause cognitive     changes if they enter the cerebral circulation in significant numbers. During total hip     arthroplasty the placement of the femoral stem leads to a rise in intramedullary pressure     which can cause fat and bone marrow debris to embolize into the systemic circulation. Total     hip resurfacing arthroplasty avoids entrance into the femoral canal. The purpose of this     study is to assess transient cognitive changes after total hip arthroplasty and compare them     to patients undergoing total hip resurfacing arthroplasty. We hypothesize that patients     undergoing total hip resurfacing arthroplasty will experience less transient cognitive     changes due to the avoidance of violating the femoral canal during the procedure.   "
246601|NCT01079481|"     The objective of this phase I study is to determine the maximum tolerated dose (MTD) of     combination therapy of paclitaxel and everolimus in small cell lung cancer patient with     previous treatment history.   "
246602|NCT01079494|"     Background: studies have demonstrated the crucial role of clinical pharmacists as integrated     part of heath care team. Not only in Jordan but also in the Middle East region, clinical     pharmacy practice is not well established. This current study is the first to evaluate     physicians - pharmacists' collaborative approach to uncontrolled blood pressure in Jordan and     the Middle East.   "
246676|NCT01080456|"     The objective of the study is to demonstrate bioequivalence between Test Product (A):     Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding     Reference Product (B): Prograf (Tacrolimus) Capsules 1 mg, manufactured by Astellas Pharma,     Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.   "
246789|NCT01082640|"     The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice     daily (BID), on renal function in gout patients with elevated serum urate levels and who have     moderate to severe renal impairment.   "
246603|NCT01079507|"     Acute lymphoblastic leukemia (ALL) is not a single disease, but a composite of heterogeneous     subgroup. Accordingly, more sophisticated classification in ALL is essential to achieve     further improvement of treatment outcomes. However, only a few genetic markers are revealed     to have significant prognostic implications in ALL patients. The current study is designed to     stratify the ALL patients according to their prognosis and to predict their outcomes by a     pharmacogenetic approach. A predictive model will be generated from 130 genotypes in adult     ALL patients diagnosed at the Samsung Medical Center (SMC), Sungkyunkwan University School of     Medicine, Seoul,Korea between 1994 and 2008. The validation of the predictive model will be     performed using an independent external cohort of ALL patients.        1. Definition of the cohort: two hundred ALL patients from the SMC as a test set, another          100 patients from the SMC as a first validation set, and another 150 independent          external patients as second external validation set. DNAs will be extracted and stored          from patients' samples collected at the time of diagnosis.        2. In the test set, genotypes will be determined using a MALDI-TOF based platform          (Sequenom, San Diego, CA, USA) for 130 SNPs of the candidate genes involved in DNA          repair pathway, drug metabolism/transport pathway and folate metabolism pathway.        3. Bioinformatic analyses will be performed to identify around 13 genotypes (10%) having          strongest predictive significance out of these 130 SNPs in terms of their treatment          outcomes, drug toxicity and prognosis in the test set.        4. These 13 genotypes will be validated in the first cohort of 100 ALL patients using a          multivariate Cox's proportional hazard model.        5. The predictive model will be built up based on Cox's proportional hazard model derived          from 13 candidate genotypes and clinical risk factors.        6. The predictive model based on pharmacogenetic information will be validated again in the          second, independent external cohort of 150 ALL patients.      Definite prognostic value was not established for genetic or molecular markers in acute     lymphoblastic leukemia (ALL) except BCR/ABL fusion gene. The current study attempts to build     up a predictive model based on single nucleotide polymorphisms (SNPs) with pharmacogenetic     approach using 130 genotypes in the multiple candidate pathways such as DNA repair pathway,     drug metabolism / transport pathway and folate metabolism pathway. The predictive model based     on SNPs will be generated and validated with respect to treatment outcomes, drug toxicity and     prognosis in adult ALL patients.      The present study will demonstrate that: 1) Pharmacogenetic information derived from SNPs     involved in the DNA repair pathway, drug metabolism/transport pathway and folate metabolism     pathway, is helpful to predict the treatment outcomes, drug toxicity and prognosis in ALL     patients; 2) Predictive model derived from pharmacogenetic information will be effective and     reasonable approach to stratify ALL patients according to their clinical outcomes; 3) The     SNP-based predictive model could be reasonably applied to the treatment of ALL patients, thus     becoming a basis for further improvement of treatment outcome; 4) Finally, this project will     enhance and facilitate the pharmacogenetic research in the hematology area, thus make the     team to lead the pharmacogenetic research in the world.   "
246604|NCT01079520|"     Accurate staging of the mediastinum is essential to evaluate prognosis in non-small cell lung     cancer and to devise an appropriate treatment plan. Mediastinal staging by surgical     techniques (mainly cervical mediastinoscopy) is considered to be the gold standard, although     surgical staging is invasive, requires general anesthesia, and is subject to potential     serious complications. Endobronchial ultrasound (EBUS)-transbronchial needle aspiration     (TBNA) is a new modality for the evaluation of mediastinal and hilar lymph node metastasis     from lung cancer. Compared to other diagnostic methods, EBUS-TBNA is a real-time procedure     that enables multiple biopsies with high-quality histologic cores under local anesthesia.     However, there have been few data on the head-to-head comparisons of mediastinoscopy and     EBUS-TBNA. The aim of this prospective study is to determine the sensitivity, specificity,     positive predictive value, negative predictive value, and accuracy of EBUS-TBNA and     mediastinoscopy in identifying N2 and N3 lymph node for patients with non-small cell lung     cancer.   "
246605|NCT01079533|"     Initiation of colon cancer screening in veterans is a theory-based stepped intervention to     increase first time colorectal cancer screening (CRCS) among male and female veterans age 50     and over.   "
246606|NCT01079546|"     The rationale for this study proposal is derived from previous case series demonstrating that     up to 60% of patients with HNSCC, especially in the oropharynx are associated with high risk     HPV infection.      In this study, we will characterize the association between HPV infection and HNSCC in Israel     and establish a program for its diagnosis and management based on HPV as a biomarker. The     rationale for the proposed research is that once it is known which types of HPV are     associated with HNSCC, this information can be used to direct diagnosis and screening effort     to high risk population. Our approach is based on establishing a multicenter consortium of     leading researchers that will establish a joint database of demographic, clinical and     biological data from various regions in Israel. For this we have assembled a     multidisciplinary research team with the scope and breath (surgical oncology, pathology,     virology and molecular biology) needed to complete all phases of the research successfully.     The research will be coordinated and performed at the Applied Cancer Research Laboratory, Tel     Aviv Sourasky Medical Center. The patients will be recruited from 7 tertiary medical centers     in Israel: Ichilov, Bellinson, Hadassa, Rambam, Soroka, Sheba and Nazeret..   "
246607|NCT01079559|"     Rationale: Infection following total knee replacement (TKA) is a devastating complication     that usually requires prosthesis removal, hospitalization while the infection is eradicated,     and a second surgery to implant a revision prosthesis. For primary TKA, prophylactic     antibiotic-loaded cement (ABC) may not only reduce the rate of infection it may also reduce     the rate of revisions due to implant loosening. Current controversy about the use of ABC     exists around the world. Without a definitive trial, patients will be exposed to a treatment     of uncertain efficacy that may cause antibiotic resistant bacterial strains and will     certainly generate high costs to the healthcare system. Purpose: To determine, 1) the extent     to which ABC compared to regular cement reduces the infection rate in patients over the first     two years following TKA and, 2) the resource use implications associated with the use of ABC     for TKA. Methods: This is a randomized clinical trial in which 8,800 patients with undergoing     primary TKA are allocated to either Simplex™ P with Tobramycin or Simplex™ P bone cement. We     will exclude patients with a prior joint infection, an allergy to tobramycin, and those with     no fixed address. All patients will be administered IV antibiotics immediately prior to     surgery. Patients and surgeons will be blind to group allocation. The primary outcome measure     is infection. Follow-up visits will take place at 6 weeks and 3, 12 and 24 months     postoperative. A blinded adjudicator will review all reported infections and determine     whether the putative infection is a study event. Blinded radiologists will interpret the 2     year series of radiographs for each patient. We will compare the rates of infection and     implant loosening between the two treatment groups using survival analyses. This study     includes a full economic analysis.   "
246621|NCT01079741|"     The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an     annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have     an excellent clinical outcome, patients diagnosed with advanced or recurrent disease,     continue to have a high mortality rate, even with initial optimal surgical resection.     Effective adjuvant strategies are needed to increase the time to progression and to decrease     the recurrence rate. Immunotherapy has long been recognized as a potential therapy for     melanoma; the goal of adjuvant vaccine therapy is to train the endogenous immune system to     recognize and target minimal residual disease.   "
246622|NCT01079754|"     This study aims to compare the efficacy of 0.05 mg and 0.1 mg spinal morphine in reducing     postoperative morphine requirement in patients undergoing vaginal hysterectomy with/without     anterior and posterior vaginoplasty.   "
246608|NCT01079572|"     Complications following total joint arthroplasty are rare, and the majority of follow-up     visits are routine. The technology now exists to conduct annual follow-up assessments without     having to physically see the patient.      This study will investigate the cost-effectiveness of web-based follow-up assessments     compared to standard in-clinic follow-ups. We will also assess patient satisfaction,     preference, and the validity of the web-based follow up assessments. Patients coming up to     their 1 year follow-up or greater will be randomized to either the web-based group or the     usual care group.      Web-based patients will complete all questionnaires using an online database system, and have     their x-ray taken at their local radiology facility. The surgeon will review radiographs     online. If there are any concerns with the x-ray or responses to questionnaires, arrangements     will be made for the patient to be seen at the clinic. Patients in the Usual Care group will     come into the clinic for their follow-up assessment and have their x-ray taken at University     Hospital as usual.      Online assessment could significantly decrease wait times in orthopaedic clinics, as well as     increase availability for OR time and new consultations. This approach could also potentially     reduce patient burden by decreasing travel distances, financial burden and time requirements.   "
246609|NCT01079585|"     The effect of 40gr Okara, on gastric emptying of standard meal (Muffin cake)   "
246610|NCT01079598|"     The purpose of this study is to demonstrate that patients will improve the immediate     treatment outcomes from successive radiofrequency ablation (RFA) of incompetent perforator     veins (IPVs).   "
246611|NCT01079611|"     Background: Estimates of central venous pressure (CVP) can be very helpful in guiding fluid     therapy in the intensive care unit, operating room or emergency room. Current standard     technique for CVP assessment is invasive, requiring insertion of a catheter into a     subclavian, internal jugular or peripheral vein. Several ultrasound based and clinical     methods have been described as potential non-invasive alternatives to assess CVP.      Aim: To prospectively evaluate the accuracy of CVP assessment by a) inferior vena cava     diameter and collapsibility b) internal jugular vein diameter c) compression sonography of a     forearm vein and d) clinical assessment of peripheral vein collapse in comparison to invasive     CVP measurement.      Study design: single center, prospective observational study      Patients and Methods:      We will examine 77 consecutive patients with invasive venous access and invasive hemodynamic     monitoring at the surgical intensive care unit (ICU). After obtaining informed consent,     ultrasound examinations of the inferior vena cava, internal jugular vein and compression     sonography of a forearm vein as well as clinical evaluation of peripheral vein collapsibility     will be performed in a random sequence by different experienced examiner. Invasive CVP is     recorded simultaneously to each measurement. Examiners are blinded to clinical parameters and     results of previous CVP measurements.      Primary endpoint: Accuracy of each non-invasive method to determine CVP defined by invasively     measured CVP.      Secondary endpoint: Comparison of the feasibility of each non-invasive method.      Expected results: We hypothesize that sonographic measurement of inferior vena cava diameter,     internal jugular vein diameter and compression sonography of a forearm vein as well as     clinical assessment of peripheral vein collapsibility are reliable methods for CVP     determination in comparison to invasive CVP measurement.      Significance: The validation and comparison of sonographic / clinic CVP assessment would     enable clinicians to choose an accurate non-invasive method to assess volume status which is     an important adjunct in the management of many critically ill patients. The non-invasiveness     of these methods broadens the feasibility to measure CVP and may guide fluid therapy in new     patient populations.   "
246612|NCT01079624|"     Academic phase 1 study which investigates the effects of the two incretin hormones     glucose-insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) on gastric emptying,     appetite, insulin release and glucose disposal in the body. The hypothesis is that incretin     hormones not only stimulate insulin release but also inhibits gastric emptying. This effect     can be utilized for further drug development.   "
246613|NCT01079637|"     Randomized clinical trial (RCT) to compare treatment failure rates of surgical arthrodesis     with MFB against cast treatment in patients suffering from early stage Charcot     neuroarthropathy (CN) of the midfoot (Sella and Barrette stages 0, 1 or 2) within the first 2     years after initial treatment. Treatment failure is defined as the occurrence of one or more     of the following: 1. Amputation, 2. Occurrence of ulcer or worsening of existing ulcer, 3.     Surgical intervention for correction of deformity after initial treatment. The secondary aims     are to compare foot function, radiologic outcome, quality of life, complications and foot     temperature between the two groups.   "
246614|NCT01079650|"     Thermal, or infrared, energy is the part of electromagnetic radiation that an observer     perceives as heat. Infrared thermography allows us to visualize temperature distribution of     the human body and has been used in medical practice since the 1950s. In current study we     would like to examine the ability of infrared thermography to detect acute appendicitis,     ovary torsion and inflammation, and testicular torsion and inflammation.   "
246615|NCT01079663|"     The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate     chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with     Peri-Implantitis.   "
246616|NCT01079676|"     This study primary objective and endpoints are compare the efficacy of two products     containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered     non-inferior to the reference product.   "
246617|NCT01079689|"     The purpose of this study is to evaluate effects on the brain after complex somatosensory     stimulation with acupuncture needle. EEG and fMRI measurements will be performed.   "
246618|NCT01079702|"     In the investigators study the investigators combine everolimus, administrated twice daily at     a fixed total dose of 10 mg continuously with capecitabine administered bid for 14 days     followed by 7 days rest. In this study, capecitabine will be dose escalated.   "
246619|NCT01079715|"     The purpose of this study is to determine whether the administration of propranolol is     effective in the treatment of the retinopathy of the prematurity.   "
246620|NCT01079728|"     Stroke-associated pneumonia (SAP) constitutes a clinically relevant complication of stroke,     because it increases the mortality and has a negative impact on the neurological prognosis of     the patient.      An early identification of patients at risk for SAP allowing an early initiation of     antiinfective therapy may improve the prognosis. To date, no reliable prediction models or     clinical scores for stroke-associated pneumonia exist. Recently, it was shown that parameters     indicating an impaired immune function are associated with the subsequent occurrence of SAP     and could therefore be used as predictors for SAP.      This study will develop and prospectively validate a prognostic score to predict SAP based on     clinical parameters. Furthermore, the study examines the prognostic properties of selected     immune and infectious parameters for the prediction and diagnosis of SAP. The study will     further address the question whether these infectious and immune parameters predict the     3-month-outcome. In a subgroup of patients, MRI parameters on stroke size and localization     will be assessed to investigate whether these parameters might allow prediction of SAP or the     3-month-outcome.   "
249413|NCT01120652|"     The purpose of this randomized controlled trial is to evaluate the efficacy of a Mind-Body     Skills Training intervention for improving mental and physical health in patients with     Systemic Lupus Erythematosus (SLE) who have comorbid depressive symptoms.   "
246624|NCT01079780|"     RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab     may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not     yet know whether giving cetuximab and irinotecan hydrochloride together is more effective     with or without ramucirumab in treating colorectal cancer.      PURPOSE: This randomized phase II trial is studying the side effects and how well giving     cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients     with advanced colorectal cancer with progressive disease after treatment with     bevacizumab-containing chemotherapy.   "
246625|NCT01079793|"     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Ixabepilone may also make     tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy     after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone when     given together with radiation therapy to see how well it works in treating patients with     high-risk stage III prostate cancer after surgery.   "
246626|NCT01079806|"     The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric     patients with chronic hepatitis B virus infection   "
246627|NCT01079819|"     The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of     BMS-708163 administered as single and multiple doses in Chinese subjects   "
246628|NCT01079832|"     RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less     damage to normal tissue.      PURPOSE: This clinical trial studies stereotactic radiosurgery using CyberKnife works in     treating women with advanced or recurrent gynecological malignancies.   "
246629|NCT01079845|"     Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents     in susceptible girls around the time of menarche. Females with PCOS have high levels of     androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and     menstrual disturbances were once considered the primary concerns, emerging data indicate that     many adolescents and young adults with PCOS are insulin resistant and at increased risk for     metabolic syndrome and diabetes. The majority of females with PCOS are obese, and excess body     fat amplifies the severity of the syndrome.      Dietary intervention is considered an important component of treatment for PCOS. However, a     consensus statement regarding optimal nutrient composition for treating adolescents and young     adults with PCOS has not been published because data are lacking to provide a foundation for     such a statement. Recognizing increased risk for diabetes in patients with PCOS, many     practitioners employ a low-fat diet as prescribed in the Diabetes Prevention Program (DPP)     for weight loss and control of symptoms.      Objective and Hypothesis. The purpose of this research study is to compare different diets     for treating PCOS. We hypothesize that a low-glycemic load diet - designed to lower blood     levels of glucose and insulin - will be more beneficial than a low-fat diet in obese     adolescents and young adults with PCOS.      Design. We propose a 6-month study in which 50 obese females with PCOS (ages 13 to 21 years)     will be assigned to receive one of two dietary treatments, with the goal of retaining 40     participants. Group assignment will be at random. One of the treatments will be a     low-glycemic load diet, and the other treatment will be a low-fat diet (modeled after the DPP     diet). Participants in both groups will receive individual nutrition education and dietary     counseling with a registered dietitian (clinic visits, telephone calls) and cooking workshops     with a chef. The purpose of the cooking workshops will be to enhance compliance with diet     prescriptions, beyond what can be achieved by nutrition education and dietary counseling in a     conventional clinic setting.      The primary outcome will be bioavailable testosterone (form of testosterone that causes     symptoms of PCOS). Secondary outcomes will include other blood tests to evaluate further high     androgen levels (total testosterone, free testosterone, sex hormone binding globulin,     dehydroepiandrosterone sulfate), clinical signs of high androgen levels (excess facial hair,     acne), glucose tolerance and risk for diabetes (determined by blood sugar and insulin     measurements), risk for cardiovascular disease (based on blood cholesterol and C-reactive     protein levels and blood pressure), body fat percentage and distribution (measured using     state-of-the-art dual energy x-ray absorptiometry and waist circumference), menstrual     cyclicity, and health-related quality of life (evaluated by questionnaire).   "
246630|NCT01079858|"     The primary objective of this study is to assess the overall Meibomian Gland Dysfunction     Subject's preference for a particular product. Dry eye symptom relief will also be evaluated     based on clinical evaluation and a set of subject questionnaires.   "
246631|NCT01079871|"     The primary objective of this study is to assess the overall Sjogren's Syndrome subject's     preference for a particular product. Dry eye symptom relief will also be evaluated based on     clinical evaluation and a set of subject questionnaires.   "
246632|NCT01079884|"     The implications of sleep as it relates to the physiology and pathogenesis of a number of     diseases has until recently been ignored. With the evolution of sleep laboratories, there is     an emerging recognition of the relationship between sleep and various gastrointestinal     diseases- in particular gastroesophageal reflux disease (GERD).( 1-5) It seems intuitive that     waking/daytime activities or events may affect sleep and that any consequent sleep     dysfunction may reciprocally further affect daytime function   "
246633|NCT01079897|"     This study evaluates the efficacy of the topical used ectoine-formulation EHK02-01 compared     to Atopiclair. Patients are examined at visit 2 (baseline visit). The patient topically     applies EHK02-01 or Zarzenda® twice daily on two symmetric lesional areas over 28 days.     Response to therapy is recorded at each visit.   "
246634|NCT01079910|"     The objective of this study is to evaluate the effect of an experimental toothpaste on     maintaining gingival health over a 24 week period measured through modified gingival index,     bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will     undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and     weekly professional tooth cleaning to bring the subjects to their optimum gingival health     prior to commencing study treatment.   "
246635|NCT01079923|"     Research has shown that Vitamin D is important in preventing rickets in children,     osteomalacia in adults, certain cancers, cardiovascular disease, Type 2 Diabetes, and     metabolic syndrome. Data suggests that Vitamin D deficiency is common throughout the world.     With increasing medical conditions being linked to Vitamin D deficiency, it is suggested that     establishing early normal Vitamin D levels is important to long term health.      There are low quantities of maternal Vitamin D that transfer from blood into breast milk.     This places nursing infants at risk of developing low Vitamin D levels, and the American     Academy of Pediatrics recommends they receive 400 international units (IU) of Vitamin D     daily. If nursing mothers were supplemented with oral Vitamin D, this may produce adequate     total Vitamin D in the breast milk for the growing infant to consume. By taking this     potential therapeutic approach, this would prevent the burden of administering an oral     Vitamin D liquid supplement to an infant.      Recent laboratory technology now allows measurement of total Vitamin D (parent Vitamin D2     plus parent Vitamin D3). The main objective of this pilot study is to compare total Vitamin D     levels resulting from daily Vitamin D supplementation of 5,000 international units of     cholecalciferol (Vitamin D3) orally for 28 days vs. 150,000 international units of     cholecalciferol orally once in healthy, non-pregnant, non-lactating female subjects aged 18 �     40. The research results will be used to help identify an optimal dosing regimen to     administer to lactating mothers to hopefully deliver adequate total Vitamin D in nursing     infants. This separate study will be conducted at a later date under a subsequent protocol.      Previous research has demonstrated that Vitamin D3 levels become undetectable within 14 days     after adult subjects received 100,000 international units of cholecalciferol. The     investigators' central hypothesis is that daily dosing of 5,000 international units of     cholecalciferol orally will maintain detectable total Vitamin D levels in serum after     fourteen days, compared to high-dose 150,000 international units of oral cholecalciferol     once.      It is anticipated the aims of this pilot study will yield the following results. First, we,     the investigators, hope to determine the resulting Vitamin D blood levels and calculate an     appropriate dosing strategy for future research. Next we plan to measure the resulting     25,hydroxyvitamin D levels that correspond with these dosing regimens, since     25,hydroxyvitamin D is the major indicator of Vitamin D status in humans. Lastly, we will     measure blood calcium and phosphorus levels to assure these doses of Vitamin D are tolerated     by healthy female subjects.   "
246636|NCT01079936|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of Revlimid (lenalidomide) and high-dose Alkeran (melphalan) that can be given to     patients with multiple myeloma who will receive an autologous stem cell transplantation. The     safety of this combination therapy will also be studied.   "
246651|NCT01080131|"     The purpose of this study was to demonstrate that canakinumab given upon acute gout flares     relieves the signs and symptoms and prevents recurrence of gout flares in patients with     frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or     colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab     was compared to the corticosteroid triamcinolone acetonide.      The purpose of the first 12 week extension study was to collect additional safety,     tolerability and efficacy data in patients who have completed the core study CACZ885H2357.      The purpose of the second one year open-label extension study was to confirm the long-term     safety and tolerability of canakinumab in patients who had completed the first extension     study.   "
246637|NCT01079949|"     Ovarian reserve is related to chronological age; 35 years of age is the accepted threshold     for significant decline in assisted reproductive technologies (ART) success with scarce     follicular recruitment and poor oocyte retrieval. New therapeutic schemes are sought to     improve follicular response in ovarian ageing because of the increasing number of infertile     women aged older than 35 years who are trying to get pregnant. The advent of gonadotropin     releasing hormone analogue antagonist (GnRHant) offers new perspectives to address the issues     related to advanced reproductive age since it prevents premature luteinizing hormone (LH)     surges while not causing suppression in the early follicular phase. Gonadotropin releasing     hormone analogue antagonists are administered in the latter stage of the ovarian stimulation     to prevent LH surge by competitive blockade of gonadotropin releasing hormone (GnRH)     receptors, thus producing a marked decrease in LH levels just when the interplay between     follicle stimulating hormone (FSH) and LH becomes important to complete follicular     development and oocyte competence. Some studies in the past have shown the potential of     recombinant human LH (r-hLH) supplementation in women of advanced reproductive age to improve     oocyte quality, but these studies are of small size and did not provide data on the     physiological mechanism behind the benefit obtained.      This randomized, comparative, parallel controlled Phase II study will be conducted in     infertile female subjects aged 35-42 years undergoing in-vitro fertilization (IVF)/intra     cytoplasmic sperm injection (ICSI), to investigate whether the addition of r-hLH (when the     lead follicle is greater than [>] 14 millimeter [mm] in size), to the standard protocol with     recombinant human FSH (r-hFSH) under GnRHant, improves the number and quality of oocytes     retrieved, implantation rate, and pregnancy rate, while assessing the hormonal milieu in the     ovarian follicular fluid. Comparison will be performed against ovarian stimulation without     addition of r-hLH, that is (i.e.) with r-hFSH under GnRHant alone.   "
246638|NCT01079962|"     Antihypertensive drugs aim to reduce blood pressure (BP) either through decrease of the total     peripheral resistance through vasodilatation at the level of arterioles (microcirculation) or     by decreasing the cardiac output through reduction of the stroke volume or heart rate or     both. On the other hand, all antihypertensive drugs might potentially decrease arterial     stiffness passively with the reduction of the distending pressure or with the     resynchronization of the reflected pressure wave. With theses potential mechanisms, it is     also expected that these drugs might exert a favorable effect on pulse pressure amplification     between central and peripheral arteries.      However, there is solid evidence that the widely applied antihypertensive drugs have     differential effect on brachial and central BP. Several reports in the past have confirmed     the potential hypothesis that beta blockers decrease central BP less than the observed     reduction at the level of the brachial artery. It has been hypothesized that deceleration of     heart rate and the re synchronizing the reflected pressure wave earlier in the systolic phase     seems to be the leading cause of non-favorable effect of beta blockers on central BP, these     effects might be partially counterbalanced in beta blockers with high beta-1 selectivity     resulting in less peripheral vasoconstriction properties.   "
246639|NCT01079975|"     This is an observational, non controlled, multicentric, prospective study planned to be     conducted in 350 subjects diagnosed with multiple sclerosis (MS) in 20 centres of Argentina     to identify the predictive factors leading to depression. The incidence of depression     symptoms and its influence in the evolution of the disease are unknown in the Argentinean     population. Early diagnosis of depression symptoms allows the specific treatment of them and     can also delay the rich apparition of the disease. This study intends to quantify the     incidence of these symptoms and also aims to evaluate which are the predictive factors of the     apparition of the depression.   "
246640|NCT01079988|"     This is a pilot investigational study of the appropriate therapeutic regimens to treat     subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon     discontinuation of efalizumab therapy and of the biological mechanisms involved in     inflammatory disease recurrence and control.   "
246641|NCT01080001|"     This is an observational, non-controlled, multicentric, prospective study planned to be     conducted in 66 subjects diagnosed with multiple sclerosis (MS) in 20 centres of Argentina.     Fatigue is recognized as one of the most frequent symptoms of MS with a high incidence in MS     subjects. The link between fatigue and the degree of disability and other manifestations of     the disease, such as depression has not been yet clearly understood. Hence, this study aims     to understand the way in which fatigue impairs the quality of life (QoL) of MS subjects. This     epidemiologic study can contribute to a better understanding of the way in which fatigue     correlates with depression and the intensity with which both situations impact on the QoL of     MS subjects.   "
246642|NCT01080014|"     This observational study is being conducted to evaluate the usefulness of the MSFC and its     relationship with EDSS scores in subjects with MS in Argentina.   "
246643|NCT01080027|"     The rationale of this study is to assess the safety profile, efficacy and adherence to Rebif®     New Formulation in real life settings with a multinational approach, as well as the impact of     this improved formulation (with regards to adverse events [AEs]) to subjects' adherence.   "
246644|NCT01080040|"     This study is observational, non-controlled, multicentric and prospective, without     experimental intervention or control. As part of the usual management of the subjects, scales     will be used for the assessment of the spasticity and the quality of life (QoL).      The purpose of this observational study is to assess the incidence of spasticity in a group     of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it     affects the QoL of these subjects.   "
246645|NCT01080053|"     This is an observational, prospective, non-interventional, non-controlled study planned to be     conducted in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS).      The purpose of this observational study is to determine the correlation between the degree of     disability and sexual dysfunction; and between the sexual dysfunction and the quality of life     (QoL) of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina.   "
246646|NCT01080066|"     This is a prospective, observational, non-interventional, multicenter, post-marketing     surveillance study to mainly collect safety information from subjects with locally advanced     and recurrent/metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) treated with     cetuximab based on the locally approved label.   "
246647|NCT01080079|"     The purpose of this study is to determine if the iontophoretic application of terbinafine gel     is safe and effective for teh treatment of distal subungual onychomycosis   "
246648|NCT01080092|"     Craving is one of the most prominent reasons for relapse after smoking cessation. Mainly     pharmacological aids (NRT, bupropion, varenicline) try to counter this condition. This     project aims to evaluate the effect of stress-management and a short breathing technique,     reinforced by means of visualisation , on the experience of craving in smokers who are     prepared to stay abstinent for at least 3 hours before the start of the intervention. It is     expected that this strategy can provide supplementary gains in craving control.   "
246652|NCT01080144|"     All patients eligible for TIPS (Transjugular intrahepatic portosystemic shunt) procedure will     be considered for inclusion. After written inform consent, psychometric tests in order to     calculate the psychometric hepatic encephalopathy (PHES) score, the gold standard for the     diagnosis of minimal encephalopathy and critical flicker frequency (CFF) will be performed     before the TIPS procedure. After TIPS, patients will be followed during one year and the     psychometric test and CFF will be performed every 3 months.      30 patients will be included.      The main endpoint is the success rate of CFF. The secondary end points are        -  Correlation between CFF and PHES score        -  Performance of CFF and PHES score to predict the occurrence of overt encephalopathy          after TIPS procedure        -  A sample collection during TIPS procedure is also performed for validation of biomarkers   "
246653|NCT01080157|"     The purpose of this research study is to test the safety and effectiveness of the SCOUT DS in     measuring the concentration of substances (advanced glycation endproducts) in the skin. These     substances have been found to be in higher concentrations in people with diabetes and high     blood sugar. The SCOUT DS is being developed to help doctors measure these substances in skin     and possibly help doctors diagnose diabetes.   "
246654|NCT01080170|"     This study explores how aromatase inhibitor therapy affects risk factors for heart disease in     postmenopausal women with breast cancer.   "
246655|NCT01080183|"     The team's ultimate goal is to improve health care quality and effectiveness and support     patient-centered care. In this project, we, the investigators, will test whether providing     patients with guideline based-recommendations regarding tobacco use, physical activity and     mental and physical health-related quality of life (patient reported measures: PRMs) using     health information technology increases doctor-patient discussions regarding these topics and     results in improvements in PRMs. We will randomize physicians in a single general internal     medicine practice. Patients seeing intervention physicians will receive guideline-based     recommendations regarding PRMs, those seeing control physicians will not. We will compare     differences in doctor-patient discussions regarding PRMs between the intervention and control     groups. The successful completion of this project will provide evidence the effectiveness of     involving patients in their care through the use guideline-based feedback.   "
246656|NCT01080196|"     This phase II clinical trial will compare the effects of a high intensity Resistance Exercise     via Negative Work (RENEW) vs. Traditional resistance exercise (TRAD) as part of a     mult-component exercise and fall-reduction program on muscle conditioning; falling risks; as     well as the fall incidence in older adults who have fallen. We anticipate that muscle     conditioning will mediate the effect of RENEW on falling risks and fall incidence.   "
246657|NCT01080209|"     This study will evaluate the biodegradation of the brimonidine tartrate posterior segment     drug delivery system.   "
246658|NCT01080222|"     The purpose of this study is to assess the safety and efficacy of combination treatment with     VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or     ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C     virus (HCV) genotype 1 and will not have previously received treatment for their HCV     infection.      This study will include an Investigational Phase and Extension Phase. These phases will     contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the     Investigational Phase of this study. Subjects who fail treatment during the Investigational     Phase will have the option to enter the Extension Phase at which point they will be eligible     to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks.      Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from     patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment     arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based     combination therapy. The components of the treatment regimens of these arms will be selected     based on clinical data that emerges from the four initially-studied regimens. If enacted, up     to 25 patients are expected to enroll in each additional treatment arm.      If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will     have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the     eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.   "
246659|NCT01080235|"     This is a multi-center exploratory study (each site got local IRB approval) of the impact of     an educational toolkit combined with a practice-performance self-evaluation instrument (ABIM     Care of the Vulnerable Elderly Practice Improvement Module) on trainee knowledge, skills, and     attitudes about practice-based learning and improvement and systems-based practice in the     care of elderly patients.   "
246660|NCT01080248|"     To determine the response rate and survival of gemcitabine and pazopanib in patients with     metastatic pancreatic cancer.   "
246661|NCT01080261|"     A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60     patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary     artery ≥2.25 mm to <2.50 mm in diameter (by visual estimate). Approximately thirty patients     will be randomly assigned to the angiographic subset to also undergo angiographic assessment     after the 12-month clinical follow-up.   "
246662|NCT01080274|"     Low vitamin D levels were found to be associated with cardiovascular morbidity and mortality.     Low zinc levels are associated with an increased atherosclerotic burden. Therefore we     hypothesized that patients with pathological stress test would have low levels of Vitamin D     and zinc compared to patients with a normal stress test.   "
246663|NCT01080287|"     This is a study to compare subject response and symptoms resulting from administration of     three clinical assessments.      * The 3 assessments are        1. passive upright tilt table testing,        2. quantitative sudomotor axon reflex testing (QSART)and        3. punch biopsy.      The comparison of results will be from two subject groups:        -  Group A, the migraine suffering patient with or without aura        -  Group B, the migraine suffering patient with or without aura who has diagnosed          orthostatic intolerance (i.e.,feeling dizzy or faint when making a body position          change).   "
246664|NCT01080300|"     Depomed's Gabapentin Extended Release is an investigational, extended release formulation of     Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in     postmenopausal women   "
246665|NCT01080313|"     The primary objective of this study is to describe, in detail, patterns of care for head and     neck carcinoma patient   "
246666|NCT01080326|"     This study is being done to see if a new approach to repair perforated ulcers in the stomach     (holes in the stomach) or the first part of the intestine is possible. Traditionally, either     open operations (large single incision) or laparoscopic operations (multiple small     camera-guided incisions) have been used to repair perforated ulcers. Over the last ten years,     some surgeons have used endoscopic equipment to assist them with performing the procedure. It     is unknown if perforated ulcer repair can be done using an endoscope as the main instrument     (a flexible tube with a video camera inserted into the stomach through your esophagus) to     patch or plug the perforation. We will patch the perforation using a standard method which     uses tissue from outside the stomach. A laparoscopic camera will also be used to assist our     view. This study is intended to be a feasibility study to demonstrate the endoscopic     technique can be safely performed      Hypothesis: The primary outcome is successful completion of the procedure.   "
246667|NCT01080339|"     Substudy examining cardiovascular and metabolic risk factor change in children at high risk     for future atherosclerosis who are enrolled in a pilot intervention using novel gaming and     exercise activities to increase physical activity.   "
246668|NCT01080352|"     Can high dose, intravenous Vitamin C prolong life for patients with metastatic prostate     cancer?      Prostate cancer is the most common cancer (excluding skin cancer) in men in Denmark and the     Unites States. When metastatic disease is present cure is no longer possible. The main     treatment at this stage is castration, either surgical or medical, ending the patients     testosterone production and causing a temporary regression in disease activity.      Eventually, the cancer will progress, usually within 2 years from the castration, with a more     aggressive course and a survival of 2-3 years.      The current treatment option for the patients, who have undergone castration and have disease     progression, is chemotherapy with only limited gains in quality of life and survival.      This clinical study is a phase 2 study to evaluate the effects of high dose intravenous     vitamin c in subjects with early castration resistant prostate cancer.      Primary endpoint:        -  Prostate specific antigen (PSA) changes after 12 to 20 weekly vitamin c infusions      Secondary endpoints:        -  Bone metastases changes after 12 to 20 weekly vitamin c infusions        -  Changes in bone specific alkaline phosphates, oxidative DNA-damage, PINP, NTX after 12          to 20 weekly vitamin c infusions        -  RNA-expression changes in prostatic tumor tissue after 12 to 20 weekly vitamin c          infusions        -  RNA-expression changes in lymphocytes after 12 to 20 weekly vitamin c infusions      Tertiary endpoints:        -  Pharmacokinetics of vitamin c in the elderly cancer patients      Methods and material:        -  80 subjects are included (efficacy evaluation when 20 subjects have been evaluated for          extension arm)        -  Each subject receives a weekly infusion of 60 grams vitamin c (in the form of ascorbate)          for 12 to 20 weeks   "
246669|NCT01080365|"     Study comparing 2 formulations of bosutinib in healthy subjects.   "
246670|NCT01080378|"     The overall objective of this study is to investigate in depth the impact of birth weight on     the nature of metabolic physiology, body composition and epigenetic differences of the     different phenotypes of overweight and obese individuals who are otherwise overtly healthy.     We also aim to determine the efficacy of a weight loss intervention on the above mentioned     metabolic parameters in these individuals.   "
246671|NCT01080391|"     To compare progression-free survival in subjects with relapsed multiple myeloma who are     receiving CRd vs subjects receiving Rd in a randomized multicenter setting.   "
246672|NCT01080404|"     Obesity is an increasing problem worldwide. Over 20% of people in western societies are obese     (BMI >30kg/m2) and 1-2 % are morbidly obese (BMI >40 kg/m2). According to the recent study     6.6% of Finns are severely obese (BMI > 35kg/m2) and 2.0% are morbidly obese (BMI>40kg/m2).     Because conventional treatments often fail to induce sustained weight loss obesity surgery     has increased rapidly in many countries. Currently, > 300000 procedures are performed in the     US each year. Thus in many European countries, including Finland, the need for obesity     surgery is rapidly increasing.      The most important risk factor also for obstructive sleep apnea (OSA) is obesity, and thus     effective treatment of obesity is the first-line treatment of OSA. However, Reliable     information of the prevalence of OSA in morbidly obese patients is still lacking. The current     knowledge is based on small studies, which have demonstrated that the prevalence of OSA may     be higher than believed, even 70-80% in morbidly obese patients. There is a definite need for     large, well-designed, prospective clinical studies to evaluate the effects of weight     reduction in OSA and other co-morbidities related to obesity. Ever increasing research data     showing a strong link between obesity and OSA and their co-existence as a major risk factor     in the development of cardiovascular diseases should provoke concepts to search better     clinical guidelines of diagnostics and treatments in a risk group, such as morbidly obese     patients.   "
246673|NCT01080417|"     The objective of the study is to compare the bioavailability and characterise the     pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India     and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA     in normal, healthy, adult human subjects under fed conditions, and to assess the     bioequivalence.   "
246674|NCT01080430|"     Rotational maneuver is a vestibular rehabilitation method, performed in a supervised manner.     Using a rotating chair, subjects are rotated towards the opposite direction of dominant side     in order to inhibit this side and simultaneously, stimulate the subordinate side. We propose     that the rehabilitative effect is the result of a decrease in the vestibular imbalance,     mainly due to a decrease in the response of the dominant vestibular side. Previously, we have     shown the short-term effects of this maneuver on patients with recent onset vestibular     imbalance. In the present study, we investigated the long-term effects of the rotational     maneuver in patients with a history of peripheral vestibular vertigo for at least one year,     originally confirmed by clinical tests. Our results show a significant improvement which     lasted for >4 weeks after the end of rehabilitation (i.e., the last time tested). Moreover,     there seems to be a relationship between the decrease in DP values and a decrease in     subjective symptoms. We propose that this maneuver can be used as an effective method for     both short- and long-term rehabilitation.   "
246675|NCT01080443|"     The objective of the study is to compare the bioavailability and characterise the     pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India     and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA     in normal, healthy, adult human subjects under fasting conditions, and to assess the     bioequivalence.   "
246678|NCT01080482|"     The objective of the study is to demonstrate bioequivalence between Test Product (A):     Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding     Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg, manufactured by Astellas Pharma,     Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.   "
246679|NCT01080495|"     Assessment of left ventricular function is an essential determinant of overall hemodynamics     and heart function and therefore of central interest in intra-operative transesophageal     echocardiography.      Currently, the most frequently used methods for quantification of left ventricular function     are fractional shortening (FS) and fractional area change (FAC).      Radial strain is a new parameter to asses left ventricular function. The investigators want     to assess left ventricular function with radial strain, fractional shortening (FS) and     fractional area change (FAC) in non-cardiac patients during non-cardiac operations. The aim     of this study is to show that radial strain is as reliable as FS and FAC in left ventricular     function assessment and more robust to changes in preload and afterload conditions.   "
246680|NCT01080508|"     The primary objective of the study is to describe the pressure patterns during esophageal and     tracheal ventilation and to validate the diagnostic algorithm.   "
246681|NCT01080521|"     This clinical trial is studying changes in brain function in patients with stage I, stage II,     stage III, or stage IV ovarian, primary peritoneal, or fallopian tube cancer who are     receiving chemotherapy. Learning about the effects of chemotherapy on brain function may help     doctors plan cancer treatments.   "
246682|NCT01080534|"     The objective of the study is to demonstrate bioequivalence between Test Product (A):     Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding     Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg, manufactured by Astellas Pharma,     Inc., USA in 36 normal, healthy, adult, male subjects under fed condition.   "
246683|NCT01080547|"     A new notionFast Track Multi-Discipline Treatment for colorectal cancer is thought with     several benefits such as shorter hospitalization stay and less costs. This randomized study     aims to compare the differences between conventional and Fast Track Multi-Discipline     Treatment for colorectal cancer in hospitalization day, complications, costs and quality of     life.   "
246684|NCT01080560|"     To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules     Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference     Product (B):Neoral (Cyclosporine capsules,USP)Modified 100mg manufactured by Novartis     Pharmaceuticals Corporation, New Jersey, in 36 healthy adult male subjects under fasting     condition.   "
246685|NCT01080573|"     This 1-arm, open-label, multicentric, observational study aims to collect subject centric     information in line with routine care. Subjects' expectations of therapy, side effect     management and lifestyle may influence adherence to therapy. This survey aims to determine     whether such factors and/or others affect the successful initiation and maintenance of Rebif     therapy.      The data collected during this study will include information on the subject's treatment     including expectations, experience, training and support. The results of the study will be     used to understand the impact on subjects' compliance and tailor training and support     services to subject's need. It will also be made available to other healthcare organisations     involved in the subjects treatment.   "
246686|NCT01080586|"     To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules     Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference     Product (B):Neoral (Cyclosporine capsules,USP)Modified 100mg manufactured by Novartis     Pharmaceuticals Corporation, New Jersey, in 78 healthy adult male subjects under fed     condition.   "
246687|NCT01080599|"     The purpose of this study is to compare the success rate of two approaches for obturator     nerve block in TURB (conventional pubic approach [Labat technique] and inguinal approach.   "
246688|NCT01080612|"     The purpose of this study is to (1) evaluate the effect of caloric intake on the     pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative     to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the     safety and tolerability of a single dose of a 330 mg pregabalin controlled release     formulation administered following various sized caloric meals and the 300 mg pregabalin     immediate release capsule administered fasted.   "
246689|NCT01080625|"     Postreperfusion syndrome (PRS) is a relatively common phenomenon in patients undergoing liver     transplantation which is characterized by an acute drop in blood pressure immediately after     the prefusion is restored to the transplanted liver. We hypothesized that PRS would be     prevented when phenylephrine or epinephrine is administered immediately prior to reperfusion     in liver transplantation.   "
246690|NCT01080638|"     Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours     infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST     elevation Myocardial infarction.   "
246691|NCT01080651|"     To evaluate the drug-drug interaction between rifampicin and voriconazole according to     CYP2C19 genotype quantitatively following a single oral administration of 200 mg voriconazole   "
246692|NCT01080664|"     EMD Serono decided to terminate enrollment based on a review of the available clinical data     and low probability of completing the trial based on the observed recruitment rate. Subjects     already enrolled in the study continued participation in the study, consistent with the     protocol, to study completion.   "
246693|NCT01080677|"     This is a research study to assess the safety of caffeine/propranolol at different dose     levels. We want to find out what effects, good and/or bad, it has on patients and their     migraines.   "
246708|NCT01080872|"     The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary     flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS)     and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months.   "
246710|NCT01080898|"     Determination of the sensitivity and specificity of different combinations of imaging     techniques (spectral domain optical coherence tomography, fundus photography and fluorescein     angiography) used for the diagnosis of choroidal neovessels complicating age -related macular     degeneration. This information will help to determine the choice of the most suitable     combination for the above diagnosis.   "
246694|NCT01080690|"     Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm     combining abdominal sonography, gastroscopy, endosonography in patients with acute right side     abdominal pain.      Patients with acute right side abdominal pain will be randomized in one of two groups. In     each group all examinations (sonography, gastroscopy, endosonography) will be performed. The     study group only defines the order of the examinations. Abdominal sonography will always be     performed before endoscopic procedures. In group 1, gastroscopy is first followed by     endosonography. In group 2 endosonography is first followed by gastroscopy.      Two physicians will review all results of all examinations, patient charts as well as a     follow up visit and establish a clinical diagnosis.      Yield of the clinical diagnosis by EUS results alone will be compared to the yield by     combined results of sonography, EGD and EUS.   "
246695|NCT01080703|"     The purpose of this study is to determine if a lower extremity strengthening program as part     of pulmonary rehabilitation will improve quadriceps muscle strength, endurance and functional     status as well as overall quality of life.      Hypothesis:        1. Lower extremity resistance training as part of a pulmonary rehabilitation program will          improve quadriceps strength, endurance and functional capacity.        2. Lower extremity resistance training as part of a pulmonary rehabilitation program will          improve quality of life in patients awaiting lung transplant.   "
246696|NCT01080716|"     This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the     WRSS1 candidate vaccine in healthy Thai adult volunteers. This study is designed as 2 parts.        -  Part 1 is a blinded, placebo-controlled inpatient trial in a total of 20 volunteers (14          vaccinees and 6 controls) to determine the safety and immunogenicity. Volunteers will be          vaccinated with a single oral dose of 104 colony forming unit (cfu) of WRSS1 or placebo          given with bicarbonate buffer.        -  Part 2 will be started approximately 60 days after WRSS1 vaccination. This part is an          inpatient phase II efficacy trial involving a challenge with the S.sonnei 53G of 10          vaccinees from the first part and 10 naïve controls.   "
246697|NCT01080729|"     This is a prospective, observational and multicentric study to compare the Gonal-f FbM     (filled by mass) dose prescribed by the doctor with the Gonal-f FbM dose determined by the     CONSORT (Consistency in r-FSH Starting doses for individualized treatment) calculator.   "
246698|NCT01080742|"     This is an observational, prospective, non-interventional, non-randomised, open label     multicentric study planned to be conducted in 1000 subjects with mild to moderate primary     hypertension in approximately 20 centres in Thailand. The purpose of this study is to examine     the beneficial effects of combination of bisoprolol with hydrochlorothiazide available as     Lodoz in treatment of Thai subjects with mild to moderate hypertension. The outcome of the     study would also provide information on the optimal daily dosage schedule as well as     adherence of Lodoz.   "
246699|NCT01080755|"     This is a multicentric, longitudinal, observational study with the prospective follow-up of     Adult subjects with Growth Hormone Deficiency (AGHD) being treated with Saizen, every six     months in the first year and then annually. At the request of health authorities, the sponsor     has arranged for the follow-up of prescriptions and treated subjects within the scope of this     indication.   "
246700|NCT01080768|"     The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can     attenuate ankle edema formation in hypertensive patients.   "
246701|NCT01080781|"     -  Background : Ephrin-B1 is part of the large Eph/Ephrin system which is involved in          cell-cell comunication. The role of Ephrin-B1 has scarcely been studied in adulthood.          Our team has shown that this protein is expressed in normal heart in mice and humans. In          mice with deletion of the gene encoding Ephrin-B1, we have shown progressive development          of dilated cardiomyopathy characterized by dramatic disorganization of cardiac tissue          architecture and decreased heart rate variability.        -  Purpose: Ephrin-B1 protein was recently identified in human heart but its putative role          remains unknown. In knockout mice, deletion of efn gene is associated with abnormalities          in cardiac architecture linked to defects in cell-cell tight junctions. From a          functional point of view, mice develop a dilated cardiomyopathy and exhibit decreased          heart rate variability in the frequency domain. The purpose of this study is to assess          if Ephrin-B1 expression is regulated in human heart and if expression level correlates          with heart rate variability.        -  Abstract: Thirty patients suffering from cardiac disease needing surgery will be          included and separated in two groups according to pressure levels in right auricle /and          or pulmonary artery. Ephrin-B1 expression will be assessed in right appendages at both          the transcriptional (quantitative PCR) and protein (Western blot) levels. Furthermore,          the putative relationship between Ephrin-B1 expression and heart rate variability (24          hours ECG recordings) will be investigated.   "
246702|NCT01080794|"     The purpose of this study is to determine if repetitive transcranial magnetic stimulation     (rTMS), a method of noninvasive brain stimulation) is effective in the treatment of the motor     (movement) and mood symptoms due to Parkinson's disease (PD).   "
246703|NCT01080807|"     The primary objective of the study is to determine whether armodafinil treatment is more     effective than placebo treatment in patients with excessive sleepiness associated with shift     work disorder (SWD) by measuring improved clinical condition late in the shift, including the     commute home.   "
246704|NCT01080820|"     The purpose of this study is to evaluate the safety and tolerability of CMX157 and the amount     of CMX157 that reaches the blood stream, the manner in which the body processes CMX157 and     the time that it takes to eliminate CMX157 following one oral dose when given to healthy     volunteers.   "
246705|NCT01080833|"     Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine     training (study group) will demonstrate improved clinical outcomes compared to those     undergoing routine ERCP training only (control group).   "
246706|NCT01080846|"     This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line     treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.   "
246707|NCT01080859|"     The purpose of the trial is to evaluate the completeness of struts coverage and vessel wall     response (strut malapposition, neoin-timal formation) to the bio-active-stent (BAS) versus     ever-olimus-eluting stent (EES) implanted for the treatment of the culprit lesion in acute     coronary syndrome.   "
246713|NCT01080937|"     During the last decade, progress has been made in the management of heart failure. However,     the changing characteristics of patients and practices in the real world and their impact     on the prognosis of patients admitted for acute heart failure remain poorly studied.      2000 consecutive patients recruited in a single day in hospitals volunteered to participate     in the cohort during a day dedicated.   "
246714|NCT01080950|"     Zinc and vitamin d deficiency are associated with a state of inflammation/atherosclerosis.      There are studies demonstrating an association between vitamin d deficiency and respiratory     illnesses.      Both zinc and vitamin d are associated with oxidative stress and inflammation.   "
246715|NCT01080963|"     The purpose of this study is to show that the incidence of sternal wound infections at day 30     after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard     antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone.   "
246716|NCT01080976|"     Abstract Diabetes behavior can be influenced by patients exploring diabetes topics that may     lack scientific credibility. The question this study examines is whether a Google or Health     on the Net (HON) internet search, presents websites that would incline a more or less likely     recommendation to patients ? A preliminary trial suggests that referrers recommend websites     based on rules that may prioritize website source over content. This study will qualitatively     assess the rules that participants use in deciding which websites are more suitable than     others.      Method The investigators will inject a diabetes related search term into a HON and a Google     search engine. The top 5 mutually exclusive websites from each search engine will be     presented to 5 people from three groups stratified across endocrinologists, informaticians     and PCPs. Participants will rank the websites and then identify the rules that they applied     to reach their decision.   "
246717|NCT01080989|"     The study project can be divided into two parts: (1) health screening for the community and     (2) clinical diagnosis and treatment for patients at National Referral Hospital (NRH) in     Solomon islands. The health screening includes a questionnaire, stool parasitic screening and     blood laboratory tests. A total of 800 subjects will participate in this study. The collected     samples are venous blood (20 ml/per subject) and stool in order to conduct the related tests     mentioned above.      As for the collection of target patients, KMUH will cooperate with NRH to collect two kinds     of blood samples: the blood samples of confirmed malarial cases and those of cases suspicious     of Flaviviral, Alpha-viral, Rickettsial, and Leptospiral infections. The expected received     cases are 600 each year. The venous blood samples (20 ml/per subject) will be used to conduct     related tests mentioned above. At the same time, the subjects will also have to fill out a     related questionnaire which includes height, weight, waist line, heath behavior and habit,     and past history, etc.   "
246718|NCT01081002|"     It is unclear whether a topical pharyngeal anesthesia adds any benefit to the upper     gastrointestinal endoscopy under a propofol sedation. We hypothesize that a topical     pharyngeal anesthesia does not ease the upper gastrointestinal endoscopy under propofol     sedation. The aim of this study is therefore to quantify the impact of a topical pharyngeal     anesthesia to the upper gastrointestinal endoscopy in patients sedated with propofol.      Patients will be randomized to receive a topical pharyngeal spray containing either an     anesthetic drug (lidocaine 10%) or a placebo. Thereafter the upper endoscopy will be     conducted in its standard manner.   "
246719|NCT01081015|"     The purpose of the Connect™ Chronic Lymphocytic Leukemia (CLL) Disease Registry is to explore     the history and real world management of patients diagnosed with CLL, provide insight into     the management of CLL, and evaluate the effectiveness of first, second and subsequent     therapeutic strategies employed in both the community and academic settings.   "
246720|NCT01081028|"     The purpose of the Connect® MM Registry is to explore the natural history and real world     management of patients with newly diagnosed symptomatic multiple myeloma (MM) and provide     unique insights into the management of MM and the impact of this hematologic disorder on     patients.   "
246721|NCT01081041|"     This study will begin with a 30 participant lead-in part: these 30 participants will receive     cetuximab manufactured by ImClone on a weekly basis in combination with other chemotherapy     drugs [cisplatin or carboplatin plus 5-fluorouracil (5-FU)] administered every 3 weeks. After     18 weeks, participants who benefit from this treatment may continue to receive cetuximab     once-weekly until progression of the disease, an unacceptable side effect occurs,     participants withdraw consent, or the study is closed.      In the second part of this study, 200 participants will be randomized in 2 arms:        -  100 participants will receive commercial cetuximab manufactured by ImClone (Group A)        -  100 participants will receive cetuximab manufactured by Boehringer Ingelheim (Group B).      All these 200 participants will receive other chemotherapy drugs (cisplatin or carboplatin     plus 5-FU) administered every 3 weeks. After 18 weeks, participants who benefit from this     treatment may continue to receive cetuximab once-weekly until progression of the disease, an     unacceptable side effect occurs, participants withdraw consent, or the study is closed.   "
246722|NCT01081054|"     The purpose of 01DIVER is to evaluate efficacy and safety of a home treatment protocol for     non complicated diverticulitis compared with management in the hospital. The hypothesis is     that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not     inferior to the conservative management in hospital in patients with acute not complicated     sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively     randomized to conservative antibiotic treatment either to ambulatory or to hospital     treatment.   "
246723|NCT01081067|"     Evaluate the effect of probiotics on stool output in children 1 - 18 months old.   "
246724|NCT01081080|"     This protocol will exploit novel state of the art cardiovascular magnetic resonance     techniques to examine important changes in the heart in children with muscular dystrophy. The     purpose of this study is to compare cardiac magnetic resonance (CMR) with the collected     cardiac outcome data obtained in protocol: PITT1109 - Cardiac Outcome Measures in Children     with Muscular Dystrophy.   "
246725|NCT01081093|"     Biventricular Pacing has been shown an improvement of symptoms in patients with heart     failure.      A temporary pacing is necessary in patients after cardiac procedures. In patients with     hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac     output and blood pressure.      The investigators propose that biventricular pacing in these patients and conditions results     in an improvement of symptoms instead of single right pacing.   "
246727|NCT01081119|"     We are currently working in 16 middle schools across Los Angeles, Santa Monica and Torrance     to test out a voluntary after school program called Project CHOICE, which focuses on helping     students decrease their alcohol and drug use. We are conducting surveys in all schools over     three years and providing the intervention in 8 schools in the 2008-2009 school year and in     the other 8 schools in the 2011-2012 school year. This is a program we have provided before     in middle schools and we found that it was effective in curbing alcohol and drug use among     students who voluntarily attended and among all students at the intervention school.   "
246728|NCT01081132|"     To assess the efficacy of optimized Extended-release Guanfacine Hydrochloride compared with     placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured     by the ADHD-RS-IV   "
246729|NCT01081145|"     The primary objective of this study is to evaluate the long-term maintenance of efficacy of     Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with     attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short     term treatment with SPD503.   "
246730|NCT01081158|"     Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCH 900518     in Naive or Treatment-Experienced Subjects Infected With Hepatitis C Virus Genotype 1     (Protocol No. P04695)   "
246731|NCT01081184|"     Neurotrophins (NTs) constitute a family of growth factors, which regulated differentiation,     proliferation, and survival of both neuronal cells and astrocytes. In recent years, several     studies have provided evidences that the cellular effects of NGF  Nerve Growth Factor ,     BDNF  Brain-Derived Neurotrophic Factor  and NT-3 are not limited to the nervous system.     Indeed, neurotrophins and their receptors are widely expressed on non neuronal cells. Data     concerning the implication of NTs and their receptors in the immune system maturation and in     the regulation of normal and pathological immune responses are numerous and suggest the     existence of a specific neuro-immunomodulation through these neuropeptides.      The aim of the study is to compare Sjögren's syndrome systemic activity to seric, lymphocytic     and conjunctival levels of NTs (i.e NGF, BDNF and NT-3). A preliminary study has previously     pointed out the link between high BDNF seric levels and Sjögren's systemic activity. The     increased levels of BDNF were correlated to T cell activation. A similar correlation between     high NGF level and hypergammaglobulinemia was also pointed out.   "
246732|NCT01081197|"     Alcohol abuse is associated with a variety of clinical diseases, but studies on prevalence of     different somatic diseases among alcohol abusers are lacking. Studies on populations in an     out-day patients' clinic are also lacking.      The investigators aim to study somatic health standard in an out-day patients' clinic     population of alcohol abusers, with regard to prevalence of different kinds of somatic     diseases, and how the interaction of somatic and psychiatric treatment can influence on     patients quality of life. Clinical examination including blood samples and echocardiographic     examinations in all participants, other additional examinations (as x-ray, CT or MRI if     indicated by clinical findings).   "
246733|NCT01081210|"     Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical     department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia,     hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall     bladder/bile tract, urine tract and venous thrombosis are common. US is the key diagnostic     tool in these diagnosis, and on early diagnosis is crucial both on behalf of the patients     well-being, and for hospital logistic reasons.        1. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool          in an department of internal medicine.           Method: All patients admitted (in certain preset periods) to Department of medicine will          be screened with pocket sized US by expert user. Changes in diagnoses, as well as          medications as a result of US screening will be the endpoints. US findings will be          validated against standard echocardiography, or standard US/CT/MRI performed at the          Radiological department.        2. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool          in a department of cardiology.           Method: All patients admitted (in certain preset periods) to Department of cardiology          will be screened with pocket sized US for heart disease, pericardial and pleural          effusion. Examinations by expert users. Specific findings could be myocardial          dysfunction as heart failure, cardiomyopathies, regional dysfunction due to ischemia,          valvular dysfunction, atrial enlargement, and pleural/pericardial effusion. Changes in          diagnoses, as well as medications as a result of US screening will be the endpoints. US          findings will be validated against standard echocardiography in all.        3. As in 1), but examination by non-expert users compared to expert users.   "
246734|NCT01081223|"     TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can     produce immune cells, called 'killer' white blood cells that have the ability to kill large     numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to     generate large numbers of those 'killer' white blood cells and to deliver those cells into     your body so that they can kill your cancer cells.   "
246820|NCT01083043|"     It is well known that lowering average blood glucose decreases the risk of diabetic     complications involving the small vessels, such as those found in the eyes, nerves and     kidney. It is less clear however, if controlling fluctuations in blood glucose will further     help to prevent such complications.      The purpose of this study is to examine the relationship between extreme fluctuations in     glucose and damage to the blood vessel lining.   "
246735|NCT01081236|"     Patients with liver cirrhosis have an increased risk to develop life-threatening     complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal     barrier, changes in numbers and composition of the intestinal microbiota and alterations in     immune defenses have been suggested to be involved in liver cirrhosis and its complications.     Dysfunction in the intestinal barrier for example results in the ongoing passage of toxic     substances from the gastrointestinal tract that may damage the liver, leading to oxidative     stress, inflammation and eventually liver cirrhosis. In addition, bacterial translocation is     considered a key step in the development of spontaneous infections, mainly SBP, in patients     with liver cirrhosis.      The investigators hypothesize that patients with decompensated liver cirrhosis have a more     impaired intestinal epithelial barrier and altered intestinal microbiota than patients with     compensated liver cirrhosis.   "
246736|NCT01081249|"     Subjects—currently in outpatient mental health care--will participate in 2 psychotherapy     sessions, one with oxytocin spray and one with placebo spray. Sessions will be videotaped,     and cortisol and heart rate will be measured. We hypothesize that oxytocin will have positive     benefits on nonverbal behavior in the therapy session, as well as have positive effects on     subjective anxiety, cortisol and heart rate.   "
246737|NCT01081262|"     This randomized phase III trial studies carboplatin given together with paclitaxel with or     without bevacizumab to see how well it works compared with oxaliplatin given together with     capecitabine with or without bevacizumab as first-line therapy in treating patients with     newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or     fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel,     oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not     yet known which regimen of combination chemotherapy given together with or without     bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.   "
246738|NCT01081275|"     This study will compare two different kinds of physical therapy to improve use of the hands     in individuals with multiple sclerosis (MS). One treatment will be Constraint-Induced     Movement therapy (CI therapy), the other will be a set of Complementary and Alternative     Medicine (CAM) treatments (yoga, relaxation exercises, aquatherapy, massage). The study will     determine which of the two forms of treatment is more successful for improving hand use.   "
246739|NCT01081288|"     Nationwide cluster-randomised trial of extending the NHS breast screening age range in     England   "
246740|NCT01081301|"     Family caregivers of terminally ill persons describe hope as inner strength that will help     them continue caregiving. Our research team has developed and pilot tested a Living with Hope     Program (LWHP) for caregivers of family members with advanced cancer, with the goal of     fostering hope and improving quality of life (www.usask.ca/nursing /research/livingwithhope).     The caregivers involved in our pilot test found the LWHP easy to use and we found some     evidence to suggest that the program may have increased their hope and improved their quality     of life. We would like to further develop and test the LWHP by finding out more about how and     how long it might work. We believe it will improve the quality of life of active and bereaved     older rural women of persons with advanced cancer and may decrease the number of     prescriptions and doctor visits over one year. Since rural women caring for persons with     advanced cancer seem to have the least hope, we want to focus on them first before including     other caregivers in our research. Two hundred rural women caring for a person with advanced     cancer will be asked to take part in this study. Their feelings of control, loss and grief,     quality of life and hope will be measured over a year. The numbers of time they visit their     physician and how many prescriptions they have over the year will also be collected. This     study will contribute to the refinement of a Living with Hope Program that may improve     quality of life and personal health of older rural women caring for their spouse with     advanced cancer and those who subsequently become bereaved.   "
246741|NCT01081314|"     Individuals with borderline personality disorder (BPD) are the quintessential multi-problem     patients, often presenting to treatment with numerous dysfunctional behaviors and comorbid     diagnoses. Dialectical Behavior Therapy (DBT) is a comprehensive, cognitive-behavioral     treatment for BPD that has been shown effective in reducing the primary problems it is     designed to treat; namely, the frequency and severity of self-injurious and suicidal     behavior, maintenance in treatment, and severe problems in living. However, the DBT treatment     manual does not currently include a protocol specifying when or how to treat posttraumatic     stress disorder (PTSD), a comorbid diagnosis that is prevalent in BPD patients and may     maintain or exacerbate BPD criterion behaviors. Similarly, many of the existing treatment     outcome studies for PTSD have excluded suicidal, substance abusing, and multiply diagnosed     patients, thereby making it difficult to determine the generalizability of these approaches     to individuals with BPD. The research proposed here is focused on the development of a     protocol based on Prolonged Exposure therapy to treat PTSD in BPD patients that can be     integrated into standard DBT, as well as the initial evaluation of this protocol's     feasibility, acceptability, and efficacy. The treatment development and pilot testing process     will occur in two phases, including measure development and standardization of the treatment     protocol via clinical pre-testing (Phase 1); and pilot and feasibility testing of the     intervention via a randomized controlled trial (RCT) comparing standard DBT + PTSD Protocol     to standard DBT Only (Phase 2). Information gathered during the pilot RCT will be used to     inform the design and conduct of a subsequent full-scale RCT. This research has the potential     to significantly expand and improve upon the most empirically supported treatment currently     available for BPD, while also demonstrating that exposure treatments for PTSD can be     implemented safely and effectively in a BPD population.   "
246742|NCT01081327|"     Patients with atrial fibrillation are often anticoagulated with Warfarin. Warfarin has a     narrow therapeutic window requiring frequent monitoring. This study aims to investigate the     incidence of adverse events in the real world for patients receiving Warfarin for lone     atrial fibrillation.   "
246743|NCT01081340|"     The purpose of this study is to examine whether we can use social networks to spread health     information and health behaviors that 1) support women in returning to their pre-pregnancy     weight after delivery; and 2) promote healthy infant feeding practices.   "
246744|NCT01081353|"     To determine the bioequivalence of new formula of aspirin relative to the established     commercial effervescent aspirin when taken orally by healthy adult subjects   "
246745|NCT01081366|"     All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel     releasing balloon for coronary arteries in daily clinical practice.   "
246746|NCT01081379|"     The purpose of this study is to find a correlation between function of cytomegalovirus     -specific T cells and the probability for intrauterine transmission.   "
246821|NCT01083056|"     This observational study investigates the effects of epimacular membrane peeling on the     structure and function of the retina.   "
246777|NCT01081795|"     The purpose of this study is to determine a recommended dose of topiramate in participants     with migraine (type of severe headache that occurs periodically and is often associated with     nausea, vomiting, and constipation or diarrhea), to verify the superiority (statistically     more effective) of the drug to placebo (an inactive substance that is compared with a drug to     test whether the drug has a real effect in a clinical trial), and to assess if a same     therapeutic effect can be observed between this study and overseas Caucasian clinical     studies.   "
246908|NCT01084200|"     Postoperative pain may be affected by general anaesthetics. The effect of propofol and     sevoflurane on postoperative pain in chinese female patients has not been demonstrated     before. This study compared the postoperative pain score in patients under general     anaesthesia maintained with propofol,sevoflurane, or sevoflurane+propofol.   "
246748|NCT01081405|"     To exploit the curative potential of allografting, the ultimate clinical goal is to separate     GVL from GVHD. In murine preclinical models, recipients of allogeneic hematopoietic cell     transplants after a preparative regimen of total lymphoid irradiation (TLI) and antithymocyte     globulin (ATG) did not develop GVHD. The murine TLI/ATG study was turned into a clinical     phase I protocol for patients with hematological malignancies, and a reduction of acute GVHD     to < 3% was observed (Lowsky R et al, N Engl J Med). This suggests that specific immune     mechanisms control GVHD and preserve GVL. The study will include patients with lympho and     myeloproliferative diseases. The conditioning regimen will consist of TLI [ten 80 cGy     fractions on day -11 through day -7 and on day -4 through day -1; the radiation field (four     fields—two anterior and two posterior) involves all major lymphoid organs including the     thymus, spleen and lymph nodes] and ATG (five i.v. doses at 1.5 mg/kg/day from day -11     through day -7). G-CSF mobilised hematopoietic cells, collected on days -1 and 0, from     HLA-identical siblings or unrelated donors will be infused on day 0. Post-transplant     immunosuppression will consist of oral cyclosporine (at 6.25 mg/kg/d) from day -3 and     micophenolate mophetile (at 15 mg/Kg bid) from day +1. The clinical primary objective is to     reduce the incidence of GVHD to < 5%, with better survival and quality of life.   "
246749|NCT01081418|"     The study examined the 12-month effectiveness of continuous therapeutic assertive community     treatment (ACT) as part of integrated care (IC) compared to standard care (SC) in a catchment     area comparison design in patients with schizophrenia spectrum disorders (SSD) treated with     quetiapine IR.   "
246750|NCT01081431|"     The purpose of this study is to determine the safety of lenalidomide and markers for disease     progression in the treatment of IPSS low- or intermediate-1 risk MDS with isolated del5q.   "
246751|NCT01081444|"     The aim of this study is to assess if rTMS on healthy hemisphere at one hertz could improve     patients with post stroke dysphagia.   "
246752|NCT01081457|"     Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive     involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been     recently developed as a successful treatment for extrapyramidal symptoms. In addition,     preliminary reports suggest that this therapy might be successful to relieve GI symptoms as     well. The aim of this study is therefore to assess the effect of deep brain stimulation on GI     voluntary as well as involuntary motility.   "
246753|NCT01081483|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of     blinded, single ascending oral doses of ABT 072 under non-fasting conditions in healthy adult     Japanese male subjects.   "
246754|NCT01081496|"     To estimate the prevalence of EGFR mutation in a representative sample of patients with newly     diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).   "
246755|NCT01081509|"     The aim of this study is to assess the patient's perception about and willingness to take his     or her medication and the influencing factors interfering with taking medication.   "
246756|NCT01081522|"     As this is a proof-of-concept study, the primary objective is to provide preliminary data on     the safety and efficacy of Bioresorbable Wound Scaffold in the management of acute wounds     left to heal by secondary intent.   "
246757|NCT01081535|"     The effect of IV PCA with ketorolac or fentanyl combined with caudal block for postoperative     analgesia in small children undergoing intravesical ureteroneocystostomy.   "
246758|NCT01081548|"     The purpose of this study is to compare the efficacy and safety of atorvastatin generic     product with reference drug.   "
246759|NCT01081561|"     This study will determine the efficacy of collagen cross linking for progressive keratoconus     and ectasia after lasik. It will try and determine which is a more effective treatment:     collagen cross linking alone or collagen cross linking combined with Intacs, a treatment     which has already been proven to be effective in decreasing corneal curvature in patients     with keratoconus.   "
246760|NCT01081574|"     The conduct of this clinical trial is aimed at determining the most suitable dose regimen for     children in different age groups, and secondarily to assess the safety and tolerability of     bilastine in this paediatric population subset.   "
246761|NCT01081587|"     This cluster-randomized trial will evaluate the impact of a multifaceted intervention     (including electronic medical alerts) coordinated by a Nutritional Support Team, on adherence     to recommended practices for care of starved children, among health personnel of a large     university hospital. A key component of the study is to assess whether improved adherence to     guidelines leads to a reduction in rates of complications.   "
246762|NCT01081600|"     HSP90 inhibition is a potentially new targeted drug modality in the treatment of HER2     positive, trastuzumab refractory breast cancer. Little is known about the pharmacodynamics of     HSP90 inhibitors in vivo, but non-invasive PET/CT imaging in a xenograft mouse model could     visualize and quantify HER2 reduction after AUY922 treatment by 89Zr-trastuzumab PET imaging.     Two doses of 50 mg/kg AUY922 resulted in a decrease in HER2 expression of approximately 50%,     quantified 6 days after the last administration of AUY922.      Visualizing HER2 expression in breast cancer patients before and early following HSP90     inhibition by means of 89Zr-trastuzumab PET, is likely to provide insight in the early in     vivo effect of HSP90 inhibition and could potentially support patient tailored therapy.   "
246763|NCT01081613|"     Inhibition of Heat Shock Protein (HSP)90 is a new, promising treatment modality for cancer     patients, particularly in the setting of resistance. A reliable read out system (biomarker)     for the evaluation of early treatment effect is of great importance in the development of     this treatment modality, and could contribute to customize this treatment for individual     patients. So far, no reliable biomarker has been described for HSP90 effect. Visualizing the     effect of HSP90 on vascular endothelial growth factor (VEGF) secretion in vivo in the     patient, by whole body 89Zr-bevacizumab uptake, can be of great importance in this respect,     and may contribute to tailored made cancer treatment. The purpose of the present study is to     evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89ZR-bevacizumab PET.   "
246822|NCT01083069|"     Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive     deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH)     lowers mortality and reduces neurologic damage after cardiac arrest. The investigators     evaluated the long term neurological outcome after mild hypothermia after restoration of     spontaneous circulation.   "
246909|NCT01084213|"     The incidence of malaria, including the incidence in pregnant women, is declining in many     African countries. Thus, there is a need to re-examine the efficacy and cost effectiveness of     giving intermittent preventive treatment with sulphadoxine-pyrimethamine in pregnancy     (SP-IPTp) on several occasions during pregnancy, an intervention that is threatened by     increasing resistance to SP. Possible alternatives to SP-IPTp need to be explored. This     applies especially to areas with highly seasonal malaria transmission where women are at risk     for only a short period of the year.      The goal of this project is to determine whether in pregnant women who sleep under a long     lasting insecticide treated bed net, screening and treatment at each scheduled antenatal     clinic visit is as effective in protecting them from anaemia, low birth weight and placental     infection as SP-IPTp.      Primigravidae and secundigravidae who present at antenatal clinics in study sites in four     West African countries (Burkina Faso, Ghana, Mali and The Gambia) will be randomised to one     of two groups. All women will be given a long lasting insecticide treated bed net on first     presentation at the antenatal clinic. Women in group 1 (reference group) will receive SP-IPTp     according to the current WHO guidelines. Those in group 2 will be screened with a rapid     diagnostic test at each scheduled antenatal clinic visit and treated if parasitaemic.     Approximately 5000 women will be recruited, 2500 in each group. Women will be encouraged to     deliver in hospital where maternal haemoglobin and birth weight will be recorded and a     placental sample obtained. Those who deliver at home will be visited within a week of     delivery and maternal haemoglobin and infant weight recorded. Mothers and infants will be     seen again six weeks after delivery. Also at delivery peripheral maternal blood sample will     be obtained for the diagnosis of malaria using RDT, microscopy and PCR. The primary end     points of the trial will be birth weight and anaemia at 38 weeks (+/-2 weeks) of gestation.     The study is powered to show non-inferiority of group 2 compared to group 1. The costs and     cost effectiveness of each intervention will be evaluated.      In the light of recent evidence suggesting that malaria infection during pregnancy,     particularly in the last trimester may influence an infant's risk of malaria, we proposed to     follow infants born to mothers recruited in the Navrongo site in Ghana who have received     either IST or IPTp in pregnancy throughout the whole of their first year of life beyond the     six weeks originally proposed. We have received approval for this from the ethic committees     at Kwame Nkrumah University of Science and Technology, Ghana Health Service and Navrongo     Health Research Centre. The aim is to obtain information on the incidence of both symptomatic     and asymptomatic malaria infections in these infants during follow up of the infants.      The study will provide information to national malaria control programmes on whether there     are alternative, safe and effective methods to the SP IPTp regimen for reducing the burden of     malaria in pregnancy.   "
246764|NCT01081626|"     This is an open-label, prospective, randomized, controlled, multicentric, multinational,     phase IV study to evaluate the use of Gonal-f in inducing ovulation in female subjects with     chronic anovulation. It has been observed that conventional high dose set up regimen of     gonadotropin and human chorionic gonadotropin (hCG) is effective in anovulatory subjects in     terms of overall pregnancy rates. However, development of multiple follicles leading to     multiple pregnancy and/or ovarian hyperstimulation syndrome (OHSS) is the major complications     associated with this high dose set up. Chronic low-dose (CLD) protocols of follicle     stimulating hormone (FSH), aimed at finding the threshold amount of FSH necessary to promote     monofolliculogenesis, have been found to be successful in reducing the rate of OHSS almost to     nil and the rate of multiple pregnancies to a minimum. This post-marketing study will     investigate tailoring of recombinant follicle stimulating hormone (r-FSH) in a large     population (N=310) of subjects from a region (North Africa/Middle East) that has not been     included in previous studies of ovulation induction in subjects with chronic anovulation. The     study aims to increase current knowledge of the efficacy and safety of Gonal-f, and provide     fertility physicians with experience in Gonal-f treatment in anovulatory infertility, thereby     contributing to the development of FSH dosing guidelines for ovulation induction by defining     the optimal CLD and Low dose (LD) regimens.   "
246765|NCT01081639|"     This was a prospective, randomised, open comparative monocentric phase IIIb study to evaluate     the convenience, safety and efficacy of follitropin alfa (Gonal-f) liquid pen compared with     follitropin beta (Puregon) liquid pen.   "
246766|NCT01081652|"     This was an open-label, randomized, comparative, phase III study to evaluate the safety and     efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular (i.m.)     administered once a day in luteal phase support in 200 Chinese female subjects undergoing     IVF/ET.   "
246767|NCT01081665|"     The aim of this post-marketing observational study is to obtain further data on the long term     use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and     according to the approved Summary of Product Characteristics for the treatment of secondary     hyperparathyroidism in hemodialysis patients in Greece.   "
246768|NCT01081678|"     This is an international, multi-center, randomized, double-blind, placebo-controlled study to     determine the efficacy, safety, and tolerability of AMG 785 in adults with a fresh unilateral     hip fracture, status post surgical fixation.      The primary hypothesis of this study is that AMG 785 compared with placebo is effective in     accelerating healing of hip fractures and improving physical functioning, as measured by the     TUG, for subjects with fresh unilateral low energy hip fractures, status post surgical     fixation.   "
246769|NCT01081691|"     The purpose of this study is to assess the safety and tolerability of CNTO 5825 following a     single intravenous (IV) or subcutaneous (SC) dose administration in healthy volunteers.   "
246770|NCT01081704|"     A study of the pharmacokinetics of ustekinumab in Chinese male subjects.   "
246771|NCT01081717|"     The participants included in this observational study will be drawn from a research database     containing claims and enrollment data for members of a large, geographically diverse US     health plan.The objective of this study is to estimate the rate of serious infections,     tuberculosis, malignancies, and other outcomes in rheumatoid arthritis, psoriatic arthritis,     and ankylosing spondylitis patients treated with golimumab, anti-tumor necrosis factor (TNF)     biologics, non-anti-TNF biologics, or systemic non-biological treatments.   "
246772|NCT01081730|"     The patients included in this observational study will be drawn from a research database     containing claims and enrollment data for members of a large, geographically diverse US     health plan. The objective of this study is to estimate the rate of serious infections,     tuberculosis, malignancies, and other outcomes in psoriasis patients treated with     ustekinumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic     non-biological treatments.   "
246773|NCT01081743|"     Context: The French Alzheimer plan 2008-2012 includes the implementation of disease     managers or social workers, from the onset of the disease, for every patient with a     diagnosis of Alzheimer disease or associated disorder. However, previous trials evaluating     the efficacy of a systematic intervention for each case from the onset of the disease,     including non complex cases, have shown little evidence.      Objective: To evaluate the efficacy of a social worker to prevent behavioural problem for     patient with a new diagnosis of Alzheimer disease or associated disorder.      Design and setting: Multicentric cluster randomized control trial. Patients from several     memory consultations and specialists (neurologist, psychiatrist or geriatrician) in France     are included.      Intervention: In addition to usual care, patients in the intervention group have systematic     home visits from a social worker and regular follow-ups by phone over a one-year period. This     social worker informs the patient and caregiver, evaluates the needs, gives advices to     prevent complications and is a link between the patient and the memory consultation or the     specialist. Patient in the control group have absolutely no intervention and are followed-up     as usually. In order to not modify the usual care, they have no information on their     participation in this trial before the one-year evaluation.      Main outcome measure: NeuroPsychiatric Inventory (NPI) administrated at one year, which     evaluates frequency, severity and repercussion of several behavioural problems. Secondary     outcomes included disability, cognition, depression, health, quality of life,     institutionalization, and resource use.   "
246774|NCT01081756|"     This was an open, randomized, comparative study using rhCG (Ovidrel) in the induction of     final follicle maturation and early luteinization in Chinese female subjects undergoing IVF     or ET.   "
246775|NCT01081769|"     The purpose of this study is to assess the efficacy (how well the drug works; primarily     through the time to relapse) of long-acting injectable paliperidone palmitate compared to     treatment as usual with orally administered antipsychotics in monotherapy over 24 months in     the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.   "
246776|NCT01081782|"     The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients     with relapsing-remitting multiple sclerosis over a 26-week treatment period.   "
246823|NCT01083082|"     Objectives: To analyze the relationship of physical activity, fitness, energy intake and     dietary pattern with the circadian pattern of blood pressure, central and peripheral blood     pressure pulse wave velocity and biological markers of endothelial dysfunction in active and     sedentary people without atherosclerotic disease.   "
246778|NCT01081808|"     RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with     antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the     lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the     number of immune cells found in bone marrow or peripheral blood. Giving laboratory-treated     autologous lymphocytes together with aldesleukin and GM-CSF may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated     autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients     with recurrent, refractory, or metastatic advanced solid tumors.   "
246779|NCT01081821|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics     (how the drug is absorbed in the body, how it is distributed within the body and it is     removed from the body over time) of single doses of JNJ-39758979 in healthy Japanese     volunteers and multiple doses of JNJ-39758979 in healthy Japanese and Caucasian volunteers.   "
246780|NCT01081834|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2     different doses of canagliflozin administered as monotherapy compared with placebo in     patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.   "
246781|NCT01081847|"     This was a phase I double blind controlled vaccine trial, evaluating safety, tolerability and     immunogenicity of mixtures of N, R and C LSP derived from the P. vivax CS protein formulated     in two adjuvants Montanide ISA 720 and Montanide ISA 51.      The primary objective was to assess in malaria-naïve adults, the safety and reactogenicity of     these peptides formulated in the two adjuvants      We recruited 40 healthy men and women volunteers from Cali, Colombia, a city non-endemic for     malaria. Volunteers were 19--41 years of age and had no history of malaria. During a period     of three months a total of 100 volunteers were assessed for eligibility criteria in order to     select a total of 40 volunteers willing to participate in the clinical trial. By consecutive     allocation, eight participants were allocated to each of the five experimental groups (A--E):     four groups (A--D) were immunized with the vaccine formulations at two different dose     concentrations and formulated in two different adjuvants. A control group (E) was injected     with placebo (saline solution)   "
246782|NCT01081860|"     The exact etiology of CTS remains yet unknown. A rise in carpal tunnel pressure is well     documented, but why this phenomenon occurs is yet unknown in most patients. There is an     absolute or relative narrowing of the carpal tunnel, which results in a compression of the     median nerve.      The investigators postulate, that a stiffer flexor retinaculum (roof of carpal tunnel) will     be less compliant. As a consequence of this stiffer retinaculum the pressure in the carpal     tunnel will rise more quickly in stiff patients resulting in CTS-complaints.      A relation between connective tissue composition and joint stiffness is proven. This     relationship possibly extends to a relation between stiffness of the skin, joint stiffness     and the prevalence of CTS.   "
246783|NCT01082562|"     The purpose of this study is to assess the safety, tolerability, serum concentrations and     pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and     multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in     subjects with elevated cholesterol (MAD).   "
246784|NCT01082575|"     The pain medication given after major surgery may cause some patients to stop breathing for     periods of time especially at night time. An oxygen monitor may reflect this abnormal     breathing pattern. This is an observational study of 100 post-operative patients who will be     monitored with a pulse oximeter for a minimum of two nights and a maximum of five nights to     determine the prevalence of this abnormal breathing pattern.   "
246785|NCT01082588|"     This study involves people with schizophrenia or schizoaffective disorder, who are currently     taking antipsychotic medications. Some antipsychotic medications may cause an increase in     cholesterol levels, which may lead to inflammation in the body. Inflammation poses a risk in     developing heart disease, diabetes and problems with brain function. The purpose of this     study is to see if pravastatin can:        -  Lower cholesterol        -  Decrease inflammation        -  Improve cognition in patients with schizophrenia   "
246786|NCT01082601|"     To compare heart function, symptoms, exercise capacity and quality of life in patients with     Congestive Heart Failure (CHF) and Atrial Fibrillation (AF)before and after catheter     ablation.      Hypothesis: Restoration and maintenance of sinus rhythm by catheter ablation, without the use     of antiarrhythmic drugs, in AF and CHF improves heart failure status.   "
246787|NCT01082614|"     This study evaluates whether using information from a special arterial blood pressure monitor     to guide how much fluid is given during surgery changes how long a patient stays in the     hospital after the surgery. There is scientific evidence from using similar information from     different devices that this technique might allow us to do a better job giving fluids during     surgery and that this may be associated with shorter hospital stay after surgery.   "
246788|NCT01082627|"     Primary Objective:      To demonstrate whether an early fixed Somatostatin treatment improves the complete recovery     rate of early postoperative simple small bowel obstruction (EPSSBO) compared with the common     daily practice      Notes:        1. complete recovery= toleration of solid food+ flatus+ passage+ recovery of bowel          movement.        2. common daily practice includes:             -  NPO (Nil per mouth), re-dehydration, TPN (Total Parenteral Nutrition) if needed.               Check & make sure stability of electrolytes daily.             -  GI (Gastro-Intestinal) depression via NGT (Naso-Gastric Tube)             -  Discontinue opiates, instead of NSAIDs. (Non-Steroidal Anti-Inflammatory Drugs)             -  Pro-dynamic drugs or other drugs which may interfere with GI (Gastro-Intestinal)               movement eg. anti-histamines, anti-cholinergic, opiates, anti-depressives are not               indicated.      Secondary Objectives:      To investigate whether an early fixed Somatostatin treatment will bring much benefit to     EPSSBO pts compared with the common daily practice,for this purpose,the study will     investigate the endpoints below.   "
246799|NCT01082770|"     This study will be a randomised controlled trial examining whether a new type of needle free     access device(TEGO) is associated with less episodes of infection of dialysis lines, when     compared to the current gold standard.      The investigators hypothesise that there will be less handling of the dialysis line by     nursing staff and thus this will lead to lower rates of infection. The investigators will     also assess whether these access devices lead to alterations in catheter blood flow rates     when compared to the current gold standard.   "
246790|NCT01082653|"     A Phase I, single center, prospective, non-randomized, open label, safety/efficacy study of     the infusion of autologous bone marrow-derived stem cells, in 6 patients with Amyotrophic     Lateral Sclerosis according to established criteria (1), (2) with a moderate to severe     diagnosis of ALS according to the World Federation of Neurology El Escorial criteria.      The primary purpose of this study is to evaluate safety of the infusion procedure, as     assessed by absence of complications at the site of infusion or the appearance of new     neurologic deficit not attributed to the natural progression of the disease.      Secondary outcomes will include a)neurological evidence of trends toward a slowing down of     the decline of the forced vital capacity (FVC) (3) and of the functional rating scale     (ALS-FRS) scores, as assessed at 3-month intervals, b)evidence of a decline of the maximum     voluntary isometric contraction-arm (MVIC-arm) and MVIC-grip Z (4) scores and c)patient     evaluation that the treatment was effective and consider the possibility of a new cell     product stem cell infusion.      Subjects who fulfill inclusion/exclusion criteria and sign informed consent will undergo an     aspiration of bone marrow from the iliac crest for preparation of the cellular product.      The day of infusion, the investigational product will be injected into the patient's     intrathecal space.      After cell infusion patients will be followed at WK 2, MN 1, MN 2, MN 6 and a long-term     followup at MN 12 in the clinic and/or office. Electromyographic (EMG) studies, Forced vital     capacity (FVC), functional rating scale (FRS) and maximum voluntary isometric contraction-arm     (MVIC-arm) and MVIC-grip Z scores will have been used to assess the status of the disease     before (historical record acceptable if done within three months of Screening Visit) and     during the 12-month study period after cell infusion.   "
246791|NCT01082666|"     We hypothesized that continuous control of tracheal cuff pressure would reduce     microaspiration of gastric content as determined by pepsin level in tracheal aspirate.   "
246792|NCT01082679|"     This pilot study is examining the feasibility of a primary care and a specialist treatment     (methadone clinic) model of treatment for 15 offenders who are part of two community     supervision programs: Drug Court and the Treatment Alternative Program (TAP) in Dane County.     The questions addressed by future larger studies based upon the current pilot-feasibility     study will center around whether access to primary health care as opposed to more traditional     methadone treatment services will improve the health and criminal justice outcomes for     participants.   "
246793|NCT01082692|"     DNA vaccines consist of small pieces of DNA also known as plasmids, and have several     potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well     tolerated in humans. We have developed DNA vaccine, PENNVAX-B, which includes plasmids     targeting the gag, pol, and env proteins of HIV-1. The vaccine will be delivered via     electroporation (EP) which uses the CELLECTRA constant current device to deliver a small     electric charge following injection, since animal studies have shown that this delivery     method increases the immune response to vaccine. The vaccine will be given to HIV-1 infected     subjects whose viral load is undetectable on a HAART regimen, with CD4 lymphocyte count above     400 cells/µL of blood. It is hypothesized that PENNVAX-B + EP will be safe and well     tolerated.   "
246794|NCT01082705|"     Following the rapid development of significant drug resistance to both chloroquine and     sulfadoxine-pyrimethamine (the first line therapy in Tanzania from 2001 -2006), artemether-     lumefantrine (Coartem or AL) was adopted as first line therapy in Tanzania in 2006. Now that     this drug has been widely used for some time, the investigators propose to conduct an     antimalarial efficacy trial to monitor the effectiveness of this therapy, to determine if     this drug remains efficacious, or if significant resistance has emerged, in which case a new     antimalarial strategy will need to be contemplated. The investigators hypothesize that the     efficacy of Artemether-lumefantrine remains high, and that the other artemisinin combination     therapies will be equally efficacious.      Children 6-59 months of age with symptomatic malaria will be randomly assigned to be treated     with either artemether + lumefantrine (Coartem) or dihydroartemisinin-piperaquine     (Duo-Cotecxin or Artekin). Clinical, parasitologic, and hematologic parameters will be     monitored over a 42-day follow-up period and will be used to evaluate drug efficacy.   "
246795|NCT01082718|"     Artemisinin-based combination therapies (ACTs) are now the treatment of choice for malaria in     non-pregnant individuals living in areas with established chloroquine resistance; they have     been shown to be both safe and highly efficacious. There is rapidly increasing experience     with artemisinin derivatives in the 2nd and 3rd trimesters of pregnancy, with over 1,000 well     documented cases with no reported serious adverse effects to mother or fetus (WHO Malaria     Treatment Guidelines, 2006). Many countries in Latin America have abandoned the previous 1st     line regimen of Quinine-Clindamycin for treatment of malaria in pregnancy, a complex and     poorly tolerated regimen with low adherence, in favor of ACTs, despite limited safety and     pharmacokinetic data on the use of these compounds in pregnant women. Lack of pharmacokinetic     data may lead to underdosing of pregnant women, with subsequent reduced efficacy and     increased potential for development of resistance.      One ACT regimen, Artesunate-Mefloquine, has been developed as a fixed-dose combination     (Farmanguinhos Artesunato + Mefloquina), as part of an international collaborative research     effort led by Drugs for Neglected Diseases Initiative (DNDi), and manufactured by     Farmanguinhos, laboratory of the Brazilian Ministry of Health. Initial clinical trials     suggest that it is very well tolerated and efficacious in both pregnant and non-pregnant     individuals. The convenient dosing afforded by a fixed drug combination make this a very     promising candidate for treatment of pregnant women with malaria. Preliminary pharmacokinetic     data from mefloquine monotherapy and prophylaxis suggest that the peak concentration of     mefloquine is lowered in pregnant women. Prior to wide-spread adoption of the     Artesunate-Mefloquine combination, further studies on safety, efficacy, and dose optimization     are imperative. We propose to compare the pharmacokinetics of the fixed combination of     mefloquine-artesunate (MA) for treatment of P.falciparum in 28 pregnant women in the second     and third trimesters to the pharmacokinetics of this regimen in 28 matched non-pregnant     P.falciparum infected women. This will allow us to determine whether the standard adult dose     is sufficient for pregnant women.   "
246796|NCT01082731|"     Data on the burden of MIP in low transmission areas, such as Latin America, are very limited;     there is even less information on the efficacy of case management of MiP. The treatment     recommendations for MiP in Latin American countries have been changing rapidly in recent     months; currently, either artemether-lumefantrine (AL) or mefloquine-artesunate (MA) is the     first line treatment for P. falciparum (depending on country); however, no data exists on the     efficacy of these drugs for the treatment of malaria in pregnancy in Latin America to support     their use.      We propose a multi-center 2-arm open-label randomized Phase 4 clinical trial to assess safety     and efficacy of the present therapies, AL and MA. We hypothesize that the drugs will both be     efficacious for use in pregnant women in Brazil.   "
246797|NCT01082744|"     The use of paravertebral catheters is a recommended technique to achieve postoperative     analgesia after thoracic surgery. To date there is no consensus on which drug regime (local     anesthetics with or without opioid) is best. The aim of this prospective clinical trial is to     determine wether the use of ropivacaine and sufentanil injected through a thoracic     paravertebral catheter results in decreased acute postoperative pain compared with plain     ropivacaine in patients after thoracoscopic lung surgery.   "
246798|NCT01082757|"     This observational, prospective, multicentric study is being conducted to record the     prevalence of KRAS mutations in the Argentine mCRC population.   "
246868|NCT01083667|"     The objective of this study will be to evaluate the safety, tolerability and effect on SOD1     levels by pyrimethamine in patients with familial amyotrophic lateral sclerosis.   "
246800|NCT01082783|"     The damage of the brain parenchyma, as well as the stroke-induced dysfunction of the     blood-brain-barrier can make previously hidden CNS antigens visible, and can thus lead to     the development of autoimmune mechanisms.      It seems plausible that stroke-associated immunodepression influences the development and the     phenotype of these autoreactive immune responses.      This study will investigate whether cerebral ischemia leads to changes in the immune     response, in particular to the development and/or proliferation of autoreactive effector     T-cells and/or regulatory T-cells. Furthermore, the association between the severity and the     phenotype of this autoimmune response and the clinical course, i.e. prognosis and mortality,     will be investigated.   "
246801|NCT01082796|"     Diabetes mellitus is a growing global disease now and future, and in China, 1.2 million     peoples per year have been diagnosed as diabetes mellitus. 90% diabetes mellitus patient is     Type 2 diabetes mellitus. Glipizide is a potent drug to service patients who suffer from Type     2 disease. Little information has been presented for the relationship between CYP2C19 genetic     polymorphism and glipizide, since recently the investigators reported that there existed a     tendency. In this study the investigators found that CYP2C19 polymorphism significantly     influenced the pharmacokinetics of glipizide.   "
246802|NCT01082809|"     The purpose of this study is to determine whether sunitinib as second-line treatment in     advanced biliary tract carcinoma   "
246803|NCT01082822|"     Cell sheet technique possess the properties of conserving the ECM, rich molecules and     retaining cell vitality, and will promote the capacity of cell adhesion and proliferation.     The stem cell based cell sheet therapy has been utilized in many fields and scored the     satisfactory results. Periodontitis is a chronic disease which causes the destruction of the     periodontal tissue and leads to the teeth loss in the end. The routine cell-based therapy to     the periodontitis was confronted with many difficulties. In the investigators previous     preclinical research, +the investigators fabricated periodontal ligament stem cell (PDLSC)     pellets and cell sheet fragment and applied them in the periodontal defect area for tissue     regeneration and periodontitis treatment. And the investigators carried out a comprehensive     study of the PDLSC allograft. The host responses and implanted cell fates were recorded.     After the scientific investigation of the preclinical study, the investigators designed the     preliminary clinical trial of PDLSC cell sheet for the chronic periodontitis therapy in the     aims to test the PDLSC fates and explore one ideal transplantation mode.   "
246804|NCT01082835|"     Jangzhuo Qinggan prescription and irbesartan in the treatment of essential     hypertension(Hepatogastric Damp-heat), randomized, parallel-controlled, multi-center clinical     study.   "
246805|NCT01082848|"     Evidence is lacking on the effects of different psychotropic drugs in the treatment of     anorexia nervosa (AR). However, HVA levels seem to be elevated in this disease, therefore     suggesting a role for drugs with a partial agonist profile on dopaminergic receptors. This is     a pilot study assessing the effects of aripiprazole in teenagers with AR, compared with a     placebo.   "
246806|NCT01082861|"     Rationale:      In march 2009 the Dutch Health Council advised to introduce general infant hepatitis B (HBV)     vaccination in the Dutch national immunization program (NIP) {Gezondheidsraad 2009 #16914}.     To reach the anticipated health benefits earlier, a catch-up vaccination in pre-adolescents     should complement the program, for girls preferably combined with human papillomavirus (HPV)     vaccination at the age of 12 years. Although the rationale is clear, particular aspects of     combining HPV and HBV vaccination deserve further attention, especially as it has been shown     that combining HPV and HBV vaccination results in reduced HBV immunogenicity/seroresponses     {Wheeler, Bautista, et al. 2008 #17284}{Pedersen 2009 #16684}. The reason for this     interference is unknown, but might be due to concomitant use of different antigens and/or     adjuvants, possibly skewing immunity in opposite directions. Despite proven immunostimulatory     effects, the use of (new) adjuvants has raised safety concern among the general public as     well {Israeli, Agmon-Levin, et al. 2009 #16924}.      Objective, Study design and Study population:      In view of the observations and concerns mentioned above, further investigation into     interference of HPV and HBV vaccination and adjuvant use is justified. In this context RIVM     propose to study single vs simultaneous HBV and HPV vaccination in 11-12-year-old girls while     monitoring antigen-related and antigen-unrelated immunological parameters. The anticipated     results will elucidate the extent of interference between simultaneous HPV and HBV     vaccination in the target group, and guide the choice for a HBV vaccine and schedule when the     HBV catch-up program is indeed introduced. Furthermore, specific immunological trends post     single and combined HPV and HBV vaccination will be elucidated, increasing the investigators     comprehension of adjuvant use.   "
246807|NCT01082874|"     Major surgeries not involving the heart are common, and major heart problems during or after     such surgeries represent a large population health problem. Few treatments to prevent heart     problems around the time of surgery have been tested. There is encouraging data suggesting     that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications,     given individually for a short period before and after major surgeries may prevent major     heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine     can prevent heart attacks and deaths from heart problems around the time of surgery.   "
246808|NCT01082887|"     The main objective of this study is to evaluate the clinical and biologic toxicity of cell     therapy by adoptive transfer of TIL in combination with intra-tumoral injections of Ad-INFg.   "
246809|NCT01082900|"     Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid     and a common cause of admission of full term infants and late pre term infants (34 to 36     weeks) to Neonatal Intensive Care Units (NICU). Both late preterm gestational age at     delivery, and mode of delivery are considered risk factors for TTN. The investigators     hypothesize that CPAP administered prophylactically in the Delivery Room via a T piece based     infant resuscitator Neopuff, to neonates at increased risk for TTN, would decrease the     incidence of TTN and thus decrease the need for hospitalization in the NICU. This is a pilot     study to evaluate the prophylactic administration of CPAP in the Delivery Room towards     prevention of TTN and it's effects on natriuretic peptides.The study will be conducted as a     randomized control trial after obtaining informed consents from the parents of eligible     infants. Infants will be randomized to receive either experimental treatment (prophylactic     CPAP) or standardized care.   "
246810|NCT01082913|"     The purpose of this study is to determine whether sacral surface electrical stimulation is     effective in the treatment of assisted reproductive technology.   "
246904|NCT01084148|"     Primary objective:      To demonstrate the long-term efficacy (response to treatment during initial therapy, time to     relapse without treatment, durability and lesional recurrence during maintenance therapy) of     V0034 CR 01B cream on uraemic xerosis in the real-life setting.      Secondary objectives:        1. To assess the local tolerance of V0034 CR 01B after long-term use        2. To assess the patient benefit and acceptability of V0034 CR 01B   "
246811|NCT01082926|"     RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the     immune system in different ways and stop tumor cells from growing. Donor T cells that are     treated in the laboratory may be effective treatment for malignant glioma. Aldesleukin may     stimulate the white blood cells to kill tumor cells. Combining different types of biological     therapies may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best way to give therapeutic     donor lymphocytes together with aldesleukin in treating patients with stage III or stage IV     malignant glioma.   "
246812|NCT01082939|"     The goal of this clinical research study is to learn if the combination of fludarabine,     cyclophosphamide, alemtuzumab, and rituximab is effective in treating chronic lymphocytic     leukemia in patients who have already been treated with chemotherapy.      Primary Objectives:      Evaluate the therapeutic efficacy, including the complete remission (CR), nodular partial     remission (NPR), and partial remission (PR) rates (overall response) of combined     cyclophosphamide, fludarabine, alemtuzumab, and rituximab (CFAR) in previously treated     patients with Chronic Lymphocytic Leukemia (CLL).      Second Objectives:        -  Assess the toxicity profile of CFAR in previously treated patients with CLL.        -  Monitor for infection and determine incidence and etiology of infection including          cytomegalovirus in patients treated with CFAR.        -  Evaluate molecular remission by polymerase chain reaction (PCR) for the clonal          immunoglobulin heavy chain variable gene in responding patients treated with CFAR.        -  Assess immune parameters, including pretreatment, during treatment, and post-treatment          blood T-cell counts and subset distribution and serum immunoglobulin levels in patients          treated with CFAR.   "
246813|NCT01082952|"     Being a key player in Asthma, eosinophils constitute a potential target to interfere with the     series of biological events leading to Asthma pathogenesis. In this proposal, the     investigators hypothesize that the interaction between eosinophils and airway smooth muscle     cells (ASM) cells plays an important role in airway remodeling. Hence the investigators will     investigate the role of eosinophils in enhancing ASM cells proliferation resulting in airways     remodeling. The investigators will also investigate the mechanism behind this phenomenon.     This will then pave the way for medical (drug) interference at one or several sites in order     to prevent one of the main potential reasons behind airway remodeling, namely     eosinophil-derived ASM proliferation.   "
246814|NCT01082965|"     The study hypothesizes that donepezil will have a positive impact on brain blood flow     deficits in subjects with memory deficits and/or mild dementia and that improvements in brain     blood flow will be accompanied by improvements in memory.   "
246815|NCT01082978|"     The PHF trial will assess the acceptability and long term outcomes resulting from the usage     of electronic (carried by the patient on a USB memory device) and paper portable health files     in a population with high intensity use of medical services. The rationale is that use of the     portable health files provides a conduit of direct communication among health care providers     of a patient's important health care information and this leads to better care and patient     outcomes.      Primary hypothesis: Addition of a patient-held portable health file (PHF) to usual care     improves patient outcome and quality-of-life compared to usual care alone.      Secondary hypothesis: Addition of patient-held portable health file (PHF) to usual care is     acceptable and satisfactory to patients and their health care providers.   "
246816|NCT01082991|"     The purpose of this study is to evaluate the accuracy of medical personnel in their ability     to predict the likelihood of non-intensive care (ICU), ward patients to clinically     deteriorate (defined as a cardiac arrest, unplanned ICU transfer, or unexpected death)via the     use of a clinical judgement-based tool designed for this study, Patient Acuity Rating (PAR),     to predict short-term clinical deterioration. We will compare the ability of this tool to     predict clinical deterioration compared to accepted physiology-based tools and tools     combining judgment and physiology as well as other markers of deterioration such as physician     order changes. We will compare the sensitivity, specificity and area under the curve of these     combined models to the predictive models including only physiology or clinical judgment. We     will assess the correlation between specific physician orders and patient deterioration to     determine whether specific clinical activities, such as emergently obtained radiology exams,     predict impending deterioration. We hypothesize that PAR will be a useful tool for predicting     clinical deterioration across the institution and that it will have a higher average accuracy     for predicting clinical deterioration in non-ICU inpatients within 24 hours than the     physiology-based tools alone. We further hypothesize that a combined metric which includes     both the PAR and the individual physiologic components that comprise physiologic tools will     not significantly improve prediction over the PAR alone. We further propose to use PAR to     prospectively risk stratify patients for preemptive evaluation by the Rapid Response Team. We     hypothesize that intervening on high risk patients by preemptively activating the hospital's     Rapid Response Team (to assess and treat patients as needed) will decrease cardiac arrest     rates and mortality.   "
246817|NCT01083004|"     A study of non-inferiority design comparing brilliant blue and indocyanine green as     intraoperative dye in macular pucker and macular hole.   "
246818|NCT01083017|"     The purpose of this study is to investigate the epidemiology of resistant hypertension,     evaluate the efficacy and feasibility of a standardized drug treatment regimen (including the     randomization of two doses of the diuretic used - chlorthalidone), study two interventions in     the group of patients that is non-compliant, and study environmental and genetic variables of     individuals with resistant hypertension in a family design.   "
246819|NCT01083030|"     The aim of the study is correlating efficacy of the treatment to the proportion of     paclitaxel-dose supplied by the catheter. Forty-five patients each will be treated by     paclitaxel-coated or uncoated conventional balloon catheters in randomized order in 3 study     centers. Main inclusion criteria are Rutherford class 2 - 5, ≥70% stenosis or occlusion in     the superficial femoral or popliteal artery, main exclusion criteria are related to the use     of paclitaxel and the need for follow-up examinations. Either clinical or angiographic     follow-up examinations are planned 6, 12 and 24 months following the intervention. Primary     endpoint is 6-month angiographic late lumen loss. Secondary endpoints are further     angiographic and clinical efficacy and various safety criteria.   "
246869|NCT01083680|"     The purpose of this study was intended to evaluate the long-term safety and effectiveness of     adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the     product label.   "
246824|NCT01083095|"     A clinical trial aimed to standardize a vivax sporozoite infection model in human volunteers     was conducted at the Malaria Vaccine and Drug Development Center (MVDC) in collaboration with     the Immunology Institute at Valle State University and the Fundación Clínica Valle del Lili     (FCVL) in Cali, Colombia.      The primary objective was to determine if naïve human volunteers could be safely and     reproducibly infected by the bite of An. albimanus mosquitoes carrying P. vivax sporozoites     in their salivary glands and a secondary objective consisted in determining the minimal     number of infected mosquitoes required to infect all volunteers, with a reproducible     pre-patent period.      The trial was divided into two steps: Step A directed to obtain human blood infected with     P.vivax parasite used to infect anopheles mosquitoes and Step B to produce P. vivax     sporozoites in Anopheles mosquitoes to determine the dose response of naive human volunteers     exposed to 3 +/- 1, 6 +/- 1 y 9 +/- 1 mosquitoes bites. A total of 15 samples of P. vivax     infected donors were used to infect different batches of mosquitoes.   "
246825|NCT01083108|"     Background:        -  Bariatric surgery is the most effective way to achieve significant, long-term weight          loss. It has also been shown to be an effective therapy for obese individuals with type          2 diabetes: more than 70 percent of patients no longer need medications for diabetes          after surgery. This resolution of diabetes is predominately caused by marked weight loss          resulting in improved insulin sensitivity. However, the beneficial effects of bariatric          surgery on type 2 diabetes cannot be accounted for entirely by weight loss, because many          bariatric surgery patients have resolution of diabetes within 1 week following bariatric          surgery, even before they lose a clinically significant amount of weight.        -  One possible reason for the rapid resolution of diabetes after bariatric surgery .is          that during the first week after surgery, patients can eat very little (about 300          Calories per day). It is well known that reducing calories to this level improves          diabetes. Another possibility is that changes in the flow of food through the intestines          may improve diabetes. Evidence for this comes from the observation that patients after          gastric bypass have better glucose levels than those who have gastric banding.          Researchers are interested in determining how much of the improvement in diabetes in the          first week after Roux-en-Y gastric bypass (RYGBP) surgery is due to restricting          calories, and how much is due to other factors, such as bypassing the upper part of the          small intestine.      Objectives:        -  To determine the change in total body insulin sensitivity after RYGBP compared to          caloric restriction without surgery.        -  To study possible reasons for improvements in diabetes after RYGBP.      Eligibility:      - Individuals 18 to 60 years of age who have a body mass index (BMI) greater than 35 and have     type 2 diabetes.      Design:      - This is not a randomized study, and patients will not receive bariatric surgery as part of     this study.      Two groups of patients will be studied: those scheduled for RYGBP surgery and those not     undergoing surgery.        -  RYGBP Surgery Participants:        -  Up to 3 weeks before surgery, participants will spend 2 nights and days at the          Vanderbilt University Clinical Research Center or the NIH Clinical Center for testing to          learn about how their bodies handle sugar and use energy. During the 5 days prior to          these tests, participants will be asked to not take diabetes medications, and will check          blood sugar at least twice a day.        -  From 8 days before surgery, participants will begin an 800 Calorie per day liquid diet          to prepare for surgery.        -  After surgery and discharge, participants will be readmitted to the Clinical Research          Center at Vanderbilt or NIH for further tests and diet monitoring. Diabetes medications          may be adjusted or stopped altogether based on the results of the tests.        -  Non-surgery Participants:        -  Participants will spend 2 nights and days in the NIH Clinical Center for testing to          learn about how their bodies handle sugar and use energy. During the 5 days prior to          these tests, participants will be asked to not take diabetes medications, and will check          blood sugar at least twice a day.        -  After the tests, participants will begin an 800 Calorie per day liquid diet for 8 days.        -  After 8 days, participants will be readmitted to the Clinical Center at NIH for 1 week          of further tests and a 300 Calorie per day diet. Diabetes medications may be adjusted or          stopped altogether based on the results of the tests.   "
246826|NCT01083121|"     Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and     observed in normal medical practice setting for not less than 3 months following first dose     of Humira. Information on demographics, diagnosis and medical history, results of     tuberculosis skin test, results of chest X-ray, Humira treatment information, concomitant     medication, physician's global assessment for effectiveness, disease activity assessment for     rheumatoid arthritis, disease activity assessment for Crohn's Disease, disease activity     assessment for Psoriasis and adverse events will be recorded on case report forms.   "
246827|NCT01083134|"     With the advances in multidetector computed tomography (MDCT) technology, CT angiography     (CTA) of the coronary arteries using 64-slice or dual-source CT systems has evolved into a     robust, alternative, noninvasive imaging technique to rule out coronary artery disease (CAD).     Reported sensitivities and specificities of coronary CTA can compete with those of catheter     angiography.      Because CT is the major source of ionizing radiation in medicine, dual isotope myocardial     perfusion scintigraphy and coronary CTA 16-, 64-slice MDCT and DSCT scanners are associated     with the highest amount of radiation dose. Recently, a new generation of MDCT machines with     even more detector row (320) has become clinically available. The maximum detector width of     16 cm enables the entire heart to be examined in a single rotation and within a single     heartbeat and is expected to substantially reduce artifacts from breathing and body motion.     Due to high volume coverage, 320-slice CT machines are able to perform a nonspiral, ECG-gated     examination of the heart within a single breath-hold.      The purpose of this study was to investigate the correlation of hemodynamic status of 320     MDCT, echocardiography, and coronary catheterization in patients who suspected coronary     artery disease.   "
246828|NCT01083147|"     The purpose of this study is to evaluate the compliance of the Foresee Home device in     intermediate AMD patients.   "
246829|NCT01083160|"     This is a prospective, single-arm, post marketing observational study in adult patients with     active rheumatoid arthritis (RA) who are discontinuing treatment due to lack of efficacy,     intolerance or to an incomplete response with either infliximab or etanercept.      The aim of this post-marketing observational study is to obtain data on clinical outcomes,     compliance and tolerability to determine the effectiveness of switching from infliximab or     etanercept to adalimumab. In this cohort, the different treatment strategies are to be     studied in the context of the routine clinical practice in the different participating     places.   "
246830|NCT01083173|"     This single-arm, multi-center, Post-Marketing Surveillance study of Kaletra     (lopinavir/ritonavir) was conducted in accordance with the approved Korean product labeling     in participants 2 years of age and older with human immunodeficiency virus type 1 (HIV-1)     infection.   "
246831|NCT01083186|"     The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in     real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and     secondary hyperparathyroidism.   "
246832|NCT01083199|"     1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate          sustainable vesico-urethral anastomosis during a radical prostatectomy procedure.        2. To assess clinical outcomes of the Device in facilitating the vesico-urethral          anastomosis following a radical prostatectomy.   "
246833|NCT01083212|"     The purpose of this study is to evaluate the effect of Gemfibrozil on the Pharmacokinetics     and Pharmacodynamics of a Single Dose of AZD1656   "
246834|NCT01083225|"     The purpose of this study is to evaluate the effect of individual user involvement in an     outpatient mental health center. The intervention consists of patients completing a     self-report symptom and problem questionnaire and reviewing it with a clinician.   "
247281|NCT01095237|"     This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm     Diameter) as superficial femoral artery bypass/interponate.      The aim of this study is to demonstrate safety of implantation, patency and durability of a     new type of vascular graft.   "
246835|NCT01083238|"     AZD5069 is a new drug being tested for the possible treatment of people with chronic     obstructive pulmonary disease (COPD).      This is not the first time that AZD5069 will be administered to humans in clinical trials. We     are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy     males and females in fed and fasted states. We will compare the way the body handles this     drug in the fed and fasted states, in subjects in the age group of 18 to 65 years. We will     compare the way the body handles this drug between the age groups of 18 to 65 years and above     65 years. We will also be studying how quickly AZD5069 is absorbed into and cleared by the     body.   "
246836|NCT01083251|"     Abstract      Telbivudine is a potent inhibitor of HBV but, due to a low genetic barrier to resistance, a     high incidence of resistance has been observed in patients with high baseline levels of     replication and in those with detectable HBV DNA after 24 weeks of therapy (A1). Telbivudine     might be used in patients with good predictors of response (HBV DNA <2 X 106 IU/ ml, i.e.     approximately 107 copies/ ml, or 6.3 log 10 IU/ ml at baseline) with verification of HBV DNA     suppression below detection in real time PCR assay at 24 weeks.(EASL Guidelines for HBV 2009)     The therapy of Pegylated-interferon-alpha-2a is considered as the standard of care for     patients with chronic hepatitis b viral infection. However, recent study by Buster et al     showed that a sustained viral response (SVR less than 2000 iu.ml at 6 months after     treatment)) is obtained in 8 % of patients with genotype D, 30% genotype A, and 20-25%     genotypes B or C (47). Vitamin D is a potent immune-modulator; and has been shown to improve     SVR in combination with peg interferone in patients with chronic HCV viral infection (48).     The impact of vitamin D on virologic response rates of interferon-based treatment of CHB is     unknown. The aim of this study therefore was to assess whether Vitamin D, added to the     conventional peg therapy in CHB, or to nucleotide analogues could improve the treatment     efficacy   "
246837|NCT01083264|"     Influence of different application sites on the blood levels after administration of a     fertility control patch   "
246838|NCT01083277|"     Acute respiratory failure requiring support with mechanical ventilation occurs with an     incidence of 77-100 per 100,000 person-years and accounts for half of all patients admitted     to the intensive care unit. Major causes of acute respiratory failure include pneumonia,     asthma, emphysema, and acute lung injury. These causes of acute respiratory failure may     result in partial lung collapse (atelectasis), and airway narrowing (bronchoconstriction)that     result in decreased oxygen levels requiring support with the ventilator. The prolonged     inactivity in the supine position associated with mechanical ventilation can further result     in atelectasis requiring increased oxygen supplementation through the ventilator.      The current standard of care in acute respiratory failure is a strategy of mechanical     ventilation using a single lung volume delivered repeatedly. However, the current standard     mechanical ventilation strategy is not consistent with the variability in respiration of     healthy humans and has been shown to contribute to increased lung injury in some studies. The     mortality associated with acute respiratory failure is high, 30-40%. Thus, improvements in     mechanical ventilation strategies that improve oxygen levels and potentially decrease further     lung injury delivered by the ventilator are warranted.      Recent studies by BU Professor Bela Suki and others in humans and animals with acute lung     injury, bronchoconstriction, and atelectasis have shown that varying the lung volumes     delivered by a ventilator significantly decreases biomarkers of lung injury, improves lung     mechanics, and increases oxygenation when compared to identical mean volumes of conventional,     monotonous low lung volume ventilation.      Therefore, we propose a first-in-human, Phase I study to evaluate the safety of this novel     mode of ventilation, Variable Ventilation, during acute respiratory failure   "
246839|NCT01083290|"     Objective is to investigate pharmacokinetics and to estimate the level of dose linearity of     spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone from     Spironolactone 25 mg, 50 mg and 100 mg Tablets   "
246840|NCT01083303|"     Background: The weight at which infants are weaned from incubators varies among neonatal     units.      Objective: To determine the effect on weight gain, temperature stability and resting energy     expenditure (REE) of weaning infants at body weight of 1500 g versus 1600 g.      Design/Methods: infants will be randomized to incubator weaning at the weight of 1500 g or     1600 g. Preterm infants 1500 g birth weight, fully enterally fed, and without supplemental     oxygen, at the postnatal age of 2 weeks will be included. Infants will be weaned to a warming     bassinet (Babytherm 8000, Dräger) set to keep a mattress temperature of 37°C while decreasing     it gradually to room temperature. Failure to wean is defined as core body temperature of <     36.1°C. Data collection included skin and rectal temperature obtained before weaning, and at     1/2, 1, 2, 6, 24, and 48 hours after weaning, weekly weight gain (g/kg/d). REE (kcal/kg/24h)     will be measured by indirect calorimetry (Deltatrac II, Finland) before and 24 hours after     weaning.   "
246841|NCT01083316|"     The drugs dexamethasone and bortezomib are both FDA-approved for the treatment of multiple     myeloma, a disease very similar to amyloidosis. However, they are currently investigational     for the treatment of amyloidosis.      We want to find out if the addition of dexamethasone and bortezomib to standard high dose     chemotherapy and stem cell transplant can help improve response.      Standard treatment includes four steps: 1) Stem Cell Mobilization (standard) 2) Stem Cell     Collection (standard) 3) Conditioning Regimen (Melphalan chemotherapy). The conditioning     regimen helps to kill the abnormal cells in the body and makes room in the bone marrow for     new blood stem cells to grow. 4) Stem Cell Infusion      Participants in this study will have an additional treatment step called induction therapy,     designed as the first step towards reducing the number of abnormal cells in the body. Two     cycles of the investigational drugs bortezomib and dexamethasone will be given during     induction therapy. In addition, bortezomib will given as part of the conditioning regimen, in     addition to the standard melphalan chemotherapy.   "
246842|NCT01083329|"     Our working hypothesis postulates that lipolysis is a determinant of inflammation in adipose     tissue (AT). Inhibition of lipolysis, e.g. using the oldest normolipidemic drug, nicotinic     acid, has proved valuable to combat the metabolic syndrome. Our proposal will determine     whether part of the beneficial effects of this antilipolytic compound is due to a diminution     of AT inflammation.      To this aim, the effect of nicotinic acid or placebo will be studied in male obese subjects     with or without a training program which goal is to enhance lipolysis.   "
246843|NCT01083342|"     The purpose of this study is to evaluate the complete response (CR) rate after HD-MTX     induction chemotherapy followed by alternative HD MTX-based and HD Cytarabine-based     combination consolidation chemotherapy   "
246883|NCT01083875|"     The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared     to a vehicle control on mucositis-related ulceration and erythema (objective score)and on     mucositis-related oral pain (subjective score).      A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining     the frequency of treatment-emergent drug-related adverse events or clinical laboratory     abnormalities.   "
246884|NCT01083888|"     To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal     anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these     patients.   "
246844|NCT01083355|"     Healthy biological systems are characterized by a normal range of variability in organ     function. For example, many studies of heart rate clearly document that loss of the normal     level of intrinsic, beat-to-beat variability in heart rate is associated with poor prognosis     and early death.      Unlike the heart, little is known about patterns of respiratory variability in illness. What     is known is that, like the heart, healthy subjects have a specific range of variability in     breath- to-breath depth and timing. Additionally, in animal models, ventilator strategies     that re-introduce normal variability to the breathing pattern significantly reduce     ventilator-associated lung injury.      Critically ill patients requiring mechanical ventilation offer an opportunity to observe and     analyze respiratory patterns in a completely non-invasive manner. Current mechanical     ventilators produce real-time output of respiratory tracings that can analyzed for     variability.      The investigators propose to non-invasively record these tracings from patients ventilated in     the intensive care units for mathematical variability analysis. The purpose of these pilot     analyses are to: (1) demonstrate the range of respiratory variability present in the     mechanically ve ventilated critically ill and (2) demonstrate the ventilator modality that     delivers or permits the closest approximation to previously described beneficial or normal     levels of variability. Future studies will use this pilot data in order to determine if the     observed patterns of respiratory variability in mechanically ventilated critically ill     subjects have prognostic or therapeutic implications.   "
246845|NCT01083368|"     RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop     the growth of tumor cells by blocking blood flow to the tumor. Giving temsirolimus together     with bevacizumab may be a better way to block tumor growth.      PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus     when given together with bevacizumab and to see how well it works in treating patients with     hormone-resistant metastatic prostate cancer that did not respond to chemotherapy.   "
246846|NCT01083381|"     In this study we want to find out whether MS14 - a herbal drug- can help Schizophrenia     patients or not.   "
246847|NCT01083394|"     The aim of this study is to perform a randomized, controlled trial to compare percutaneous     transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional     balloon for treatment of superficial femoral artery in-stent restenosis.   "
246848|NCT01083407|"     This experimental study aims to verify the influence of the oral hygiene performance with     chlorhexidine digluconate 0.12% in the development of VAP in children. The data collection     begun in April, 2005 during the performance of the masters degree course dissertation     entitled Clinical study about the effect of the oral hygiene with chlorhexidine digluconate     0.12% in the oropharynx colonization of children in intensive care, being performed in a     PICU of nine beds in a university hospital in the city of São Paulo, after approval of the     Research Ethics Committee of the institution. The study is composed by three types of     variables: Independent variable, dependent variables, and complementary variables. The     categorical variables will be analyzed in accordance with the Person's Chi-Square test of or     Fisher's exact test. The numerics will be submitted to the analysis of variance ANOVA or     Kruskall Wallis. For variables with heterogeneous distribution between the groups, the     multivariate analysis will be applied to the evaluation of the influence in the determination     of the development risk of the dependent variable. The rejection level will be fixed in 0.05     of the nullity hypothesis.   "
246849|NCT01083420|"     The aim of the present study is to assess the clinical efficacy of topical minocyclin in     managing of symptoms associated with oral lichen planus (OLP). The rationale of the study is     based on our previous studies demonstrating the beneficial effect of minocyclin mouthwash on     recurrent aphthous stomatitis. The planned study will be a randomized controlled, cross-over     trail. Patients with symptomatic OLP will randomly receive minocycline or dexamethasone     rinses.      The patients will rinse and expectorate 5 ml of the 1st mouthwash 4 times daily for 14 days.     Subjects will complete a daily follow-up form that includes data regarding the daily     intensity of pain (using VAS) caused by OLP and regarding possible side effects. After a     washout period (at least 14 days) the patients will repeat the protocol with the second     mouthwash.   "
246850|NCT01083433|"     The purpose of this research study is to find out ways to help pre-teens and teens and their     families to improve diabetes control and to help with the burden of diabetes management.     Specifically, the study aims to find out if coming to diabetes clinic more frequently and for     a longer period of time helps adolescents with diabetes, and if adolescents who wear a     continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.   "
246851|NCT01083446|"     This trial will study a possible effect of standard Israeli breakfast (30% of caloric value     and 21 gram protein) on cognitive and executive functions (working memory, visual memory,     concentration and coordination), on patients with mild-moderate liver cirrhosis.   "
246852|NCT01083459|"     The purpose of this study is to determine the impact of pneumococcal conjugate vaccine on     carriage of pneumococcus in the nasopharynx and on the incidence of invasive pneumococcal     disease in the community.   "
246853|NCT01083472|"     The objective of this study is to compare the incidence of post-repair wound related     complications, including hernia occurrence/recurrence, between challenging abdominal wall     defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by     standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair     will reduce the incidence of these post-repair complications.   "
246854|NCT01083485|"     The purpose of this study is to demonstrate that treatment with OXN PR tablets is non     inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with     postoperative pain after knee arthroplasty based on average pain intensity scores.   "
246855|NCT01083498|"     The purpose of this study is to determine whether the use of ablative fractional laser is     effective in the treatment of Becker's nevus.   "
246885|NCT01083901|"     The purpose of this study is to determine if taking the pain reliever acetaminophen (ACET)     interferes with some of the benefits of weight lifting on muscles and bone density in older     men.   "
246856|NCT01083511|"     The study will be conducted with nasopharyngeal swab specimens collected prospectively from     individuals suspected of having an acute respiratory tract infection caused by an Influenza     virus. A series of standard viral culture tests validated for routine use in the clinical     laboratory, as well as the CDC swine H1N1 test will be used to establish a collection of well     characterized specimens. For each specimen four (4) aliquots will be prepared. One aliquot     will be tested in real-time using the requisite viral culture reference methods, one aliquot     will be used for H1N1 reference testing, one aliquot will be used to extract nucleic acid in     real-time, and one aliquot of the UTM will be archived for the purpose of sequencing to     confirm Influenza-positive specimens. The extracted nucleic acid and any remaining specimen     will be stored at -70°C for later testing by the artus Influenza RG PCR test, or other     investigational method(s).   "
246857|NCT01083524|"     Hypothesis: The small molecule and metabolic modulator Dichloroacetate (DCA) is safe,     tolerated as a potential therapy in patients with moderate or severe Pulmonary Arterial     Hypertension (PAH).      This is a Phase I, two centre study in subjects with PAH WHO functional class III-IV whose     symptoms have been clinically stable on their prescribed medical treatment (which includes     endothelin and/or phosphodiesterase type 5 inhibitors) for 8 weeks prior to enrollment. Such     patients will be given either DCA 3.0 mg/kg BID (group I), 6.25 mg/kg BID (group II) or 12.5     mg/kg BID (group III) as an additional treatment for 16 weeks. The design is open-label with     the subjects acting as their own controls.      Primary endpoint is the safety and tolerability of DCA. Secondary end points include: a)     functional capacity including a change in the 6 minute walk form baseline, b) change in     pulmonary vascular resistance (measured by right heart catheterization), c) right ventricular     volumes and mass (measured by MRI), d) NT-proBNP levels changed from baseline, e) change in     FDG-glucose uptake in the lung and right ventricle (measured by PET) and f) change in quality     of life indices.      15 evaluable patients in each site are expected to be included.   "
246858|NCT01083537|"     The best way to treat MBO in patients with ovarian cancer has not been studied enough by     trials that assess how more than one treatment arm (surgical, chemotherapeutic, supportive     care approaches) affects clinical outcomes like resolution of bowel obstruction, survival,     and quality of life. To improve patient outcomes, we must assess which patients will do     better with palliative surgery, chemotherapy, or best supportive care. This study will gather     safety information, and how reasonable it is to give chemotherapy and BSC to patients with     advanced ovarian cancer and MBO who are non-surgical candidates. This study will also look     into the effects of chemotherapy and BSC on the quality of life and resolution of bowel     obstruction, in hopes to perform future studies that lead to the best management of MBO.   "
246859|NCT01083550|"     In this study, we will test, using a randomized controlled trial design, whether the use of a     computer-based decision aid (DA) may improve general knowledge and reduce personal decisional     conflict in patients with early stage papillary thyroid cancer (PTC), when compared to usual     care. Patients with early stage PTC will be required to have surgical pathologic criteria for     which adjuvant RAI treatment may be considered optional.   "
246860|NCT01083563|"     The purpose of this study is to examine the effect of anti-TNF therapy on rheumatoid     arthritis using magnetic resonance imaging (MRI) and ultrasound imaging.      Anti-TNF therapies include a group of medications such as Enbrel, Remicade and Humira that     affect your body's inflammatory response. These medications are routinely prescribed for the     treatment of rheumatoid arthritis.   "
246861|NCT01083576|"     The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy     of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in     subjects with cutaneous leishmaniasis (CL).   "
246862|NCT01083589|"     The goal of this clinical research study is to learn how effective the combination of the     drugs imatinib mesylate (Gleevec®) and docetaxel (Taxotere®) is in treating non-small cell     lung cancer (NSCLC). The safety and tolerability of this drug combination will also be     studied.   "
246863|NCT01083602|"     This study is designed to assess the effectiveness of the combination of Panobinostat plus     Bortezomib and Dexamethasone in patients with relapsed and bortezomib refractory Multiple     Myeloma.   "
246864|NCT01083615|"     The purpose of this study is to determine if the addition of study drug (custirsen) can     provide durable pain palliation for castrate resistant prostate cancer patients receiving     docetaxel retreatment or cabazitaxel as a second line therapy.   "
246865|NCT01083628|"     This study will assess the feasibility and acceptability of using mobile phone text messages     (SMS) as adjuncts to existing group cognitive-behavioral treatment (CBT) for depression at     San Francisco General Hospital. Patients in current groups will be given the option to     participate in a text-messaging adjunct in lieu of the usual paper and pencil homework that     is typically assigned during group sessions. They will also be provided with CBT relevant     tips and skills to employ during particularly stressful times. Participants will receive     daily text messages asking them what their mood is, this will help them become aware of their     mood state and provide feedback to the group leaders as to the progress of the patient.     Patients will also receive 1-2 additional messages a day depending on the module of focus for     that month (i.e. thoughts, activities, people, and health). These additional messages include     1) thought tracking (both positive and negative), 2) tracking of pleasant activities, 3)     tracking of positive and negative contacts, 4) tracking of physical wellbeing. Additionally,     participants will receive reminders of weekly group meetings in an attempt to improve     adherence. Patients that are taking medication will be offered to receive reminders to take     medication according to their prescribed regimen. Another component of the SMS messages will     allow patients to text the keyword STRESSED and receive a randomly generated message that     will suggest cognitive and behavioral tips to counteract the stress or sad mood. They will     also be able to text the word HELP and receive the number for a suicide hotline or be     prompted to contact 911 for an emergency. Lastly, participants will be given feedback on     their mood, behaviors and cognitions through visual graphs that display their status over     time. This will allow patients to see the connection between mood behavior and cognition.     This study is not intended to test hypotheses.   "
246866|NCT01083641|"     The purpose of this study is to determine the effectiveness of Estradiol treatment for     advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study     will also use tumor tissue from your original diagnosis or from a biopsy you may have had for     your cancer to look at hormone receptors in the lab. The tissue left over from your previous     surgery or a previous biopsy will be used for research tests to check whether a different     estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen     work better.   "
246867|NCT01083654|"     The purpose of this community-based study is to evaluate the effectiveness of a     culturally-tailored smoking cessation treatment for American Indian (AI) smokers as compared     to standard evidence-based cessation treatment (not culturally-tailored).   "
246870|NCT01083693|"     The aim of this post-marketing observational study is to obtain further data on the     evaluation of quality of life outcomes of HUMIRA® in routine clinical use in patients with     Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) after     unsustainable clinical response to disease modifying antirheumatic drugs (DMARD) and or     biological disease modifying antirheumatic drugs (BDMARD). Treatment strategies in moderate     to severe rheumatoid arthritis, psoriatic arthritis and in severe active ankylosing     spondylitis commonly consist of introducing biologics after conventional disease modifying     antirheumatic drugs or non steroidal antiinflammatory drugs fail. Although biologic disease     modifying antirheumatic drugs are generally well-tolerated, intolerances may develop or     efficacy may diminish, at which time another biologic disease modifying antirheumatic drug     might be considered. This study shall evaluate the quality of life outcomes of HUMIRA®, given     after conventional disease modifying antirheumatic drugs and or non antiinflammatory drug     failures and or after biological disease modifying antirheumatic drug failures . Failure in     this context means primary or secondary loss of efficacy or intolerance to the initial agent.   "
246871|NCT01083706|"     This phase II trial studies how well azacitidine works in treating patients with relapsed     myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid     leukemia (AML) who have undergone stem cell transplant. Drugs used in chemotherapy, such as     azacitidine, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing.   "
246872|NCT01083719|"     HYPOTHESIS AND SAMPLE SIZE The tumor delineated by FDG-PET is significantly different from     the delineation achieved by MR T1 contrast weighted images in glioblastoma; expecting a     standard error of 12.5 % (a confidence interval of 25%), with a confidence level set at 95%,     a sample size of 15 patients would be accrued in the study.   "
246873|NCT01083732|"     To investigate the safety and tolerability of dabigatran etexilate solution in children and     to obtain preliminary pharmacokinetic/pharmacodynamic data   "
246874|NCT01083745|"     The etiology of infertility in the majority of patients with poor response to ovarian     stimulation remains unknown. This study will investigate the role of immune cells (T cells, B     cells, dendritic cells and NK cells), that constitute the immune system which normally fights     infection and cancer. We, the investigators, have found that specialized NK cells that help     with new blood vessel formation, are found in the fluid surrounding the egg during IVF, only     in patients with good response to ovarian stimulation. We now wish to expand our studies and     correlate our findings to ovarian blood flow , as measured by 3D ultrasound and to the     presence of other cells in the immune system.   "
246875|NCT01083758|"     The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO     80185 topical suspension in adolescent subjects (aged 12 to 17 years) with scalp psoriasis.     LEO 80185 topical suspension has marketing approval in many countries under the brand names     Taclonex Scalp® Topical Suspension and Xamiol® gel for the treatment of scalp psoriasis in     adults. No studies have been performed in subjects younger than 18 years.   "
246876|NCT01083771|"     The purpose of this study is to assess for changes in a patient's overall energy level and     well-being (quality of life) after 8 weeks of dietary intervention.   "
246877|NCT01083784|"     Cardiac arrest is a leading cause of sudden death, but the survival rate of cardiac arrest is     only 5-35%.      Although, the first resuscitation of cardiac arrest patient would be success, the hypoxic     brain injury after cardiac arrest is an important cause of the mortality and the morbidity.      For the management of the hypoxic brain injury after cardiac arrest, American Heart     Association and European Resuscitation Council recommend induced mild hypothermia therapy.     And, ILCOR(International Liaison Committee on Resuscitation) announced the standard treatment     of post cardiac arrest syndrome(the success state of first resuscitation of the cardiac     arrest patient) included the induced mild hypothermia therapy at September, 2008.      The generalized seizure and myoclonus arise in over 60% of post cardiac arrest syndrome     patients and they are very difficult to control. Also, the occurrence of them implies poor     prognosis of the patient.      Although, mild hypothermia therapy could be decrease the development and propagation of     generalized seizure and myoclonus theologically, the therapy could not prevent the     development and propagation of them entirely. Therefore, the use of prophylactic     anticonvulsant should be needed. But, there is not randomized control study about the use of     prophylactic anticonvulsant.      We hypothesized that the use of prophylactic anticonvulsant to post cardiac arrest syndrome     patients would decrease the rate of occurrence of generalized seizure and myoclonus and would     improve the neurologic outcome.      We planed that we used two anti-epileptic drugs - valproate, clonazepam - for the     prophylactic anticonvulsant. The valproate and clonazepam are in general use for prevention     and treatment of generalized seizure and myoclonus and are recommended to treat of     generalized seizure and myoclonus to post cardiac arrest syndrome patients by 2008 guideline     of ILCOR.   "
246878|NCT01083797|"     This study evaluates the use of dexmedetomidine or chloral hydrate for sedation during     electroencephalography in patients with neurological disorders. The hypothesis is that this     drugs provides similar changes in EEG pattern.   "
246879|NCT01083810|"     Long term observation of patients under lopinavir/ritonavir containing therapy   "
246880|NCT01083823|"     We will modify our existing VMQ/VADIS mood telemetry software to run on a Motorola platform,     and enhance it to collect information on both mood symptoms (currently covered by the     VMQ/VADIS) as well as daily life stressors (currently outside the VMQ/VADIS' scope). By doing     so, we will be able us to examine the role of daily stressors in the lives of teens with and     without mood swings, to identify how changes in mood triggered by stressful events are     similar to or different from mood changes linked to the bipolar disorder, borderline     personality disorder, or other forms of affective instability.   "
246881|NCT01083849|"     The purpose of this study is to obtain data on the safety and effectiveness of Zemplar®     (paricalcitol) injection and paricalcitol capsules in real-life clinical practice.     Participants, who have been treated with paricalcitol in-label in an everyday setting, have     been included into this study. A period of 12 months has been chosen in order to also obtain     experience on the maintenance dose and treatment optimization with paricalcitol injection and     paricalcitol capsules in long-term use.   "
246882|NCT01083862|"     Study objective was to explore the impact of health literacy on effectiveness of an     educational intervention describing life-style and behavior modification for patients Living     with Coronary Artery Disease. Our hypothesis was that a VHS/DVD version of this educational     program would be superior to printed material alone in its impact on patients' knowledge     about coronary artery disease and important life-style changes. Furthermore, we believed this     effect would be most notable among patients with low health literacy. We also were interested     in the impact of the interventions on secondary outcomes including - health behaviors, health     outcomes and patients' subjective experiences.   "
246886|NCT01083914|"     The purpose of this study is to compare blood loss and the number of transfusions received by     each patient having coronary bypass surgery. The second purpose is to determine how the level     inflammation in patients during and after surgery may affect a patient's response to surgery     and the recovery process.   "
246888|NCT01083940|"     In response to the Finding Answers: Disparities Research for Change call for proposals by the     Robert Wood Johnson Foundation, we were funded to evaluate the effectiveness of a planned     computerized decision support (CDS) intervention aimed at medical providers to overcome     clinical inertia when treating blood pressure for hypertensive patients. Based on prior     evaluation of the Brigham and Women's Hospital (BWH) adult primary care clinics, we     hypothesize that racial and ethnic differences in blood pressure outcomes are largely     attributable in differences in providers' aggressiveness in managing patients with     hypertension based on patients' race and ethnicity. Within our network of 14 hospital and     community-based Brigham and Women's Hospital adult primary care clinics, we aim to determine     if the use of CDS to remind to medical providers of poorly controlled hypertensive patients     to intensify their hypertension therapy will improve overall rates of blood pressure control     and reduce the previously documented racial and ethnic disparities in blood pressure outcomes     among our hypertensive patient population. Clinics will first be stratified by location     (hospital-based versus community-based) and within each strata will be randomized to either     have their providers receive CDS for hypertensive patients whose most recent blood pressure     was uncontrolled or to usual care for hypertensive patients. More specifically, we will     evaluate our planned intervention by utilizing an 18 month cluster-randomized controlled     trial to examine the effectiveness the CDS for intensification of hypertension therapy in:     improving levels of blood pressure control, improving provider adherence with recommended     changes in drug therapy, and reducing racial/ethnic disparities in the processes of     hypertension care and outcomes among our patients receiving primary care for a diagnosis of     hypertension.   "
246889|NCT01083953|"     The purpose of this study is to determine the optimal volatile anaesthetic (sevoflurane and     desflurane) to remove a Supreme LMA in adults in which there is minimal airway response.      Null hypothesis: there is no significant difference between the optimal end tidal     concentration of sevoflurane and desflurane for Supreme LMA removal.   "
246890|NCT01083966|"     A recent study by Plotkin et al. showed that bevacizumab (Avastin) treatment was followed by     clinically meaningful hearing improvement, tumor-volume reduction, or both in some, but not     all, patients with Vestibular Schwannoma (VS) who were at risk for complete hearing loss or     brain-stem compression from growing VS. Because of the promising results in preliminary     studies of Bevacizumab and because of significant experience with the safety of the dosages     proposed in this study, this study will offer a safe treatment for patients with VS.     Therefore, this phase I clinical research trial will test the hypothesis that Bevacizumab can     be safely used by direct intracranial superselective intraarterial infusion up to a dose of     10mg/kg to ultimately enhance survival and hearing function of patients with VS.   "
246891|NCT01083979|"     The objective is to instill liposomes reconstituted with sterile water into the bladder as a     compassionate use treatment in one patient with ulcerative interstitial cystitis (IC).   "
246892|NCT01083992|"     Sedentary lifestyle and poor dietary choices are leading to a weight gain epidemic and     increasing the risk for developing nonalcoholic fatty liver disease (NAFLD). The strong     relationship between insulin resistance and NAFLD suggests that adding Vitamin D TO insulin     sensitizing therapies such as Galvus (vitagliptin) might be beneficial in the prevention or     improvement in NAFLD. Considering the close relationship between NAFLD and T2DM and lipid     metabolism, we assume that adding vitamin D to Galvus, may be effective for NAFLD by     improving lipid metabolism and by improving type 2 diabetes mellitus (T2DM).   "
246893|NCT01084005|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to     stable treatment in elderly patients with T2DM with insufficient glycaemic control   "
246894|NCT01084018|"     The purpose of this project is to develop and evaluate the effects of a computer-tailored     intervention targeting pain barriers and catastrophizing in adults having cardiac surgery.      The hypotheses are that in the experimental group, in comparison to the control group,     participants will show lower levels of pain, less pain interference in their activities, less     attitudinal barriers, and less pain catastrophizing.      A pilot-RCT is privileged to assess the preliminary effects of the intervention on the     following outcomes: pain intensity, analgesic consumption, pain interference, barriers and     pain catastrophizing.   "
246895|NCT01084031|"     Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation     induction.   "
246896|NCT01084044|"     Ulinastatin reduce the amount of bleeding and fibrinolysis in high risk patients undergoing     off-pump coronary bypass surgery (OPCAB).   "
246897|NCT01084057|"     RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing or     by stopping them from spreading. Vorinostat may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Giving ixabepilone together with vorinostat may     kill more tumor cells.      PURPOSE: This randomized phase I trial is studying the side effects, best way to give, and     best dose of vorinostat when given together with ixabepilone in treating patients with breast     cancer that has spread to another place in the body.   "
246898|NCT01084070|"     The traditional postoperative care after abdominal surgery included the need of nasogastric     tube, fasting until resumed bowel function and progressive reinstitution of oral intake from     liquid to solid diet. Recent studies have shown no benefits of this traditional management     over early oral feeding. Nevertheless, the researches in emergency surgery are scarce.   "
246899|NCT01084083|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Radiation therapy uses high energy     x-rays to kill tumor cells. Giving paclitaxel, cisplatin, and cetuximab together with     radiation therapy may kill more tumor cells.      PURPOSE: This phase II trial is studying paclitaxel, cisplatin, and cetuximab to see how well     they work when followed by cetuximab and two different doses of intensity-modulated radiation     therapy in treating patients with HPV-associated stage III or stage IV cancer of the     oropharynx that can be removed by surgery.   "
246900|NCT01084096|"     Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal     mortality through increasing the rate of antenatal corticosteroid administration to eligible     women.   "
246901|NCT01084109|"     The specific aims of this project is to determine the impact of a daily intake of one half     ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18     mo) on linear growth velocity, zinc and iron intakes and status, brain growth and     neurocognitive development, and infectious disease morbidity in populations traditionally     dependent on non-micronutrient fortified plant foods for complementary feeding.   "
246910|NCT01084226|"     The purpose of this study is to investigate the antioxidative effects of alkylresorcinols     (AR), originating from the rye fiber, on serum LDL particles and the use of AR or it's     metabolites as biomarkers for rye fiber intake and the effect of additional plants sterols,     incorporated in the rye bread, on serum total and LDL cholesterol concentration.   "
246911|NCT01084239|"     The growing availability of cardiac computed tomography (CT)* in emergency departments (EDs)     across the U.S. expands the opportunities for its clinical application, but also heightens     the need to define its appropriate use in the evaluation of patients with acute chest pain.     To address this need, we performed a randomized diagnostic trial (RDT) to determine whether     integrating cardiac CT, along with the information it provides on coronary artery disease     (CAD) and left ventricular (LV) function, can improve the efficiency of the management of     these patients (i.e. shorten length of hospital stay, increase direct discharge rates from     the ED, decreasing healthcare costs and improving cost effectiveness while being safe).   "
246912|NCT01084252|"     Primary Objective:      Phase 1:      To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984     (Isatuximab).      Phase 2 (stage 1):      To evaluate the activity of single-agent Isatuximab at different doses/schedules and to     select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as     single agent or in combination with dexamethasone.      Phase 2 (stage 2):      To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the     selected dose/schedule from stage1, as single agent (ISA arm) and in combination with     dexamethasone (ISAdex arm).      Secondary Objectives:      Phase 1:        -  To characterize the global safety profile including cumulative toxicities.        -  To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing          schedule(s).        -  To assess the pharmacodynamics (PD), immune response, and preliminary disease response.      Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent:        -  Safety        -  Efficacy as measured by duration of response, clinical benefit rate, progression free          survival, overall survival.      Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex):        -  Safety        -  Efficacy as measured by duration of response, clinical benefit rate, progression free          survival, overall survival.   "
246913|NCT01084265|"     This was a prospective, open, non-comparative study to evaluate the safety and efficacy of     recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in     follicular development during ovulation induction in 31 Chinese female subjects with     hypogonadotropic hypogonadism.   "
246914|NCT01084278|"     The primary objective of this study is to compare the pharmacokinetic profiles of colchicine     and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of     colchicine in healthy adults with normal renal function, in patients with mild, moderate or     severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An     additional objective of this study is to study the clearance of colchicine and its     metabolites by hemodialysis. Secondary objectives include evaluation of the safety and     tolerability of colchicine in the study population.   "
246915|NCT01084291|"     Dengue viruses can cause dengue fever and other serious health conditions, primarily     affecting people living in tropical regions of the world. There are four types of dengue     virus, and infection with one does not offer protection against the others. This study will     test whether a vaccine developed to prevent infection with dengue virus type 1 (DEN1) causes     a response in people's immune system and is safe.   "
246916|NCT01084304|"     Approximately 150 female volunteers wishing to become pregnant will be recruited via web     recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation     tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All     volunteers will complete study questionnaires and provide a urine sample at designated time     points though out the menstrual cycle.      A sub-arm to this study, applied the same protocol to women in an infertility treatment     setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to     this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a     diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe     male-factor infertility (with <5 million motile sperm per ejaculate). For this arm, the     protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.   "
246917|NCT01084317|"     The aim of the research is to assess the duration of a delay in asthma diagnosis in children     after the Program for Prevention of Allergic Diseases. Risk factors for delayed diagnosis of     asthma in children will also be assessed. This study will answer the question of whether this     ratio depends on the time, which indirectly proves that it can be changed by local     intervention programs. Prove lasting effects of the Program may contribute to planning     further local interventions focused on improving medical care for patients with bronchial     asthma in the Lodz region, and reduce social costs associated with this disease.   "
246919|NCT01084343|"     This study is designed to investigate the safety and efficacy of a newly developed vaccine     against HIV-1 in female healthy subjects. Safety will be assessed by local and systemic     adverse reactions, investigations of blood and urine, and physical exam including vital sign     measurements. Efficacy will be assessed in blood, and in vaginal and rectal mucosal samples.   "
246920|NCT01084356|"     The purpose of the study is to check if the new CZT system has an advantage in detection of     small osseous processes, thyroid adenomas, parathyroid adenomas and detection of sentinel     node, in comparison with the techniques in use.      Participants: 100 subjects male and female that come to the institute of nuclear medicine for     routine screening examinations.      The CZT screening takes 10 minutes and does not require any extra intervention to the routine     screening.   "
246935|NCT01084551|"     The objective of this study is to evaluate the clinical efficacy and safety of SPM962 in     patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg     during a 13-week dose-titration and maintenance period. This is a multi-center, randomized,     placebo-controlled, double-blind, 3-armed parallel group comparison study.      Efficacy will be determined by investigating the superiority of SPM962 to placebo in terms of     the primary efficacy variable, change in International Restless Legs Syndrome Rating Scale     (IRLS) total score from baseline to the end of the dose-maintenance period.   "
246936|NCT01084564|"     Cost effectiveness analysis of local management of patients diagnosed with heart failure     disease compared with an ideal guideline-based management.   "
246921|NCT01084369|"     Diabetes mellitus is associated with long-term complications affecting mainly the eyes,     nerves and kidneys. One of the main underlying causes for this is damage to the lining of the     small blood vessels supplying these organs with dysfunction of the endothelium (lining of the     small blood vessels). Testosterone has been shown to have an effect macro (large) blood     vessels with limited data available on the micro (small) blood vessels. Testosterone is     recognised to have important effects on metabolism and vascular behaviour beyond the accepted     effects on secondary sexual characteristics. Physiological testosterone therapy is associated     with some beneficial effects on the cardiovascular system and has been used with some success     to treat patients with stable angina and chronic heart failure. The investigators therefore     propose to study the effects of testosterone replacement therapy in patients with     hypogonadism (low testosterone levels) on the endothelium in males with type 2 diabetes. 40     diabetic patients with type 2 diabetes and low testosterone levels and erectile dysfunction     (impotence) will be recruited into the study. All patients will receive testosterone     replacement therapy and 10 patients will also receive Vardenafil (a drug used to treat     impotence). The investigators hope to demonstrate an improvement in endothelial dysfunction     by assessing biochemical markers such as nitric oxide (a chemical that causes relaxation for     the blood vessels) and C-reactive protein (a chemical that can increase in patients with     diabetes) as well as the effect on weight, blood pressure, diabetes control and cholesterol.   "
246922|NCT01084382|"     Early interests in Arthrospira p. (Spirulina) were based on its high source of protein.     Recently, it has drawn attention for its therapeutic effects including anticancer properties,     antiviral and antibacterial properties as well as improvement of the immune system.      The aim of this study is to investigate the effect of a daily supplementation with Spirulina     for adult wife living with HIV/AIDS in Yaoundé.   "
246923|NCT01084395|"     The broad objective of this project is to test the efficacy of a theory-based HIV     risk-reduction intervention, which includes both an adolescent component and parental     component, designed to reduce the adolescents' risk of sexually transmitted HIV.   "
246924|NCT01084408|"     The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please     angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a     drug eluting stent.   "
246925|NCT01084421|"     The purpose of this study is to examine the efficacy of a brief culturally appropriate and     theory-based parental communication intervention designed to improve parent-adolescent sexual     communication and reduce adolescent sexual risk behavior.   "
246926|NCT01084434|"     The aim of the study is to investigate the effect of dietary supplements such as probiotic,     prebiotic and synbiotic on the immune response to influenza vaccination and faecal microbiota     in adult healthy volunteers.   "
246927|NCT01084447|"     The purpose of this study is to assess the effect of post-operative inspiratory muscle     training on muscle strength and endurance in patients with obesity submitted to gastroplasty.   "
246928|NCT01084460|"     Gastric gastrointestinal stromal tumors (GISTs) less than 2 cm are usually followed up     conservatively. However, little is known about the natural course of small GISTs. The goal of     this study was to evaluate the clinical course of the small EUS-suspected gastric GISTs and     to determine the size predicting subsequent progression with increased malignant potential.   "
246929|NCT01084473|"     The aim of the study is to determine the effect of dexmedetomidine infusion on gastric     emptying and oro-caecal transit time in healthy volunteers, judged by measuring plasma     paracetamol concentrations after paracetamol ingestion and pulmonary hydrogen measurement     technique after lactulose ingestion. The effects of dexmedetomidine will be compared to the     effects of morphine and placebo.   "
246930|NCT01084486|"     Abstract      Background: Insulin resistance has an important role in the development of nonalcoholic fatty     liver disease (NAFLD) and is involved in both pathological processes: hepatic steatosis and     atherosclerosis. Therefore, treatment of NAFLD with insulin sensitizers is likely to have a     favorable effect towards hepatic steatosis and cardiovascular outcomes.      Objectives: The present study investigated the effect of metformin on arterial properties,     metabolic parameters and liver function in patients with NAFLD. Methods In randomized,     placebo controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1     received daily metformin; Group 2 received placebo. Pulse wave velocity (PWV) and     augmentation index (AI) were performed using SphygmoCor (version 7.1, AtCor Medical, Sydney,     Australia) at baseline and at the end of 4-month treatment period.. Metabolic measures and     serum adiponectin levels were determined.   "
246931|NCT01084499|"     Bioequivalence   "
246932|NCT01084512|"     Objective: To investigate the movement strategy of breathing based on three-compartment model     measured by optoelectronic plethysmography (OEP) and electromyography (EMG ) among     individuals with and without spinal cord injury in supine posture during deep inspiration.      Design: cross sectional repeated-measure with age matched control group. Setting: Motion     Analysis Laboratory Participants: Seven tetraplegic and five paraplegic subjects and twelve     age matched healthy controls were recruited.      Intervention: Not applicable.   "
246933|NCT01084525|"     The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral     Meniere's disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere's disease     will also be evaluated.   "
247282|NCT01095250|"     This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the     treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic     immunosuppression.   "
246934|NCT01084538|"     This is the post-marketing study conducted in two countries: Croatia and Serbia. In both     countries Zemplar (paricalcitol) is the first injectable form of any Vitamin D Receptor (VDR)     activator available for chronic kidney disease patients on hemodialysis. The evaluation of     outcomes of VDR activator treatments in clinical practice is a major challenge in the     management of this patient population. The aim of this post-marketing observational study is     to obtain further data on the outcomes of Zemplar Injection administration during routine     clinical use.   "
246937|NCT01084577|"     A prospective, comparative, randomised study to compare the effects on ulcer healing of     AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to     Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.   "
246938|NCT01084590|"     The pediatric primary care setting is a relatively untapped resource for addressing obesity     prevention. The main goal of this study is to evaluate the efficacy of a relatively low cost     pediatric primary-care based obesity prevention intervention. The intervention will consist     of brief pediatrician counseling as well as phone coaching for parents with overweight     children who are between the ages of five and nine. We propose to enroll and randomize 425     parent-child dyads with children who have a measured body mass index (BMI) the 75th and 95th     percentile. They will be randomized one of into two groups, the (a) Healthy Eating/Physical     Activity Intervention, or the (b) General Healthy/Safety/Injury Prevention Contact Control     Intervention. Both groups will receive brief pediatrician counseling regarding their child's     current BMI percentile status and recommendations for home environmental changes to achieve a     healthy weight gain trajectory and to improve home safety and reduce injury risk. This will     be paired with a 12 month home-based program delivered via phone by health behavior     specialists to help parents make environmental changes specific to their group assignment.   "
246939|NCT01084603|"     A comparison of three products for oral nicotine replacement with respect to pharmacokinetics     after single-dose of nicotine.   "
246940|NCT01084616|"     It is known that vaginal bacteria have an impact upon the health status of the host, in some     cases protecting against infection and in other cases causing infection, depending on the     bacterial types present. This study will compare the composition of vaginal bacteria to     symptoms of vaginal dryness in order to try and identify if certain bacteria might cause some     of the problems associated with vaginal dryness among post-menopausal women.   "
246941|NCT01084629|"     The purpose of this study to assess post ablation, if there are areas of Barrett's mucosa     post ablation and to assess the ability of the Fujinon FICE system to detect this, as     compared to white light endoscopy. A subgroup will also be compared with laser confocal     microscopy   "
246942|NCT01084642|"     The purpose of this study is to survey female cancer patients' awareness of and preference     for methods to improve sexual health. This information will help to improve our understanding     of the needs and preferences for sexual health strategies and interventions of our female     patients.      The findings of this survey will also be used to develop feasible sexual health resources for     our patients and enhance the success of grant proposals to support future sexual health     interventions at MSKCC.   "
246943|NCT01084655|"     This is an open-label, multicenter, Phase 1/2 study of TAK-700 in combination with docetaxel     and prednisone that will evaluate the safety and pharmacokinetics (PK) of the combination and     will allow estimation of prostate-specific antigen (PSA) response in men with metastatic     castration-resistant prostate cancer (mCRPC).   "
246944|NCT01084668|"     The aim of this post-marketing observational study (PMOS) was to obtain further data on     long-term safety, efficacy, and quality of life outcomes for adalimumab in routine clinical     use in participants with moderate to severe chronic plaque psoriasis after unsustainable     clinical response to other biologic disease modifying anti-rheumatic drugs (BDMARDs). There     are few data so far showing the effects of switching from other BDMARDs to adalimumab in     patients with moderate to severe chronic plaque psoriasis. This study was designed to     evaluate the long-term effectiveness of adalimumab in participants with moderate to severe     chronic plaque psoriasis using the Psoriasis Area and Severity Index (PASI) in participants     previously treated with efalizumab, infliximab, or etanercept and who either never achieved     satisfactory response, achieved satisfactory response initially but lost it over time, or     discontinued treatment due to intolerance/side effect(s) or other reasons, for example after     regular stop of etanercept.   "
246945|NCT01084681|"     To date the standard non-surgical treatment strategy for treating un-ruptured intracranial     aneurysms is the use of either coils or self-expandable stents. This post-market clinical     investigation compares the efficacy of using the CE-marked, commercially available SILK     Artery Reconstruction Device against commercially available intracranial coils in the     endovascular treatment (occlusion) of intracranial aneurysms.   "
246946|NCT01084694|"     The purpose of this study is to examine the impact that serving as a caregiver for a patient     undergoing hematopoietic stem cell transplant has on the caregiver. This will include looking     at the caregiver's level of burden, depression, anxiety, somatic symptoms, fatigue and     overall distress. It will also look at whether caregiver burden leads to an increase in     hospitalization and overall outcome.   "
246947|NCT01084707|"     A comparison of three products for oral nicotine replacement with respect to pharmacokinetics     after multiple-doses of nicotine.   "
246948|NCT01084720|"     -  To evaluate the palliative effects of a moisturising emollient, in patients with uremic          xerosis of moderate, severe or very severe intensity, associated or not to uremic          pruritus.        -  To assess the local tolerance of the test product and its vehicle, and to evaluate the          overall agreement (efficacy, tolerance easiness of use) of the patients for the test          product.   "
246949|NCT01084733|"     The objective of this study is to evaluate the relationship between serum nicotine levels and     tumor response of squamous cell cancers of the head and neck (SCCHN) to radiotherapy alone or     in combination with chemotherapy.      Correlation of RECIST response, volumatic response, pathologic response (in patients     receiving post-treatment neck dissection), and hemodynamic response (tumor oxygenation and     blood flow) will be performed.   "
246950|NCT01084746|"     The primary goal of this research project is to conduct a 5-year prospective randomized trial     of a theory-based intervention to increase patient completion of colorectal cancer screening     (CRCS) among patients ages 50 to 64 years old.   "
246974|NCT01076946|"     Transient left ventricular ballooning syndrome (TLVBS) is a cardiac syndrome that is     characterised by acute but transient left ventricular (LV) dysfunction.      Since the syndrome clearly is not a rare phenomenon and since prognosis is not as benign as     originally thought, there is a need for further research into the etiology and     pathophysiology of TLVBS. Therefore the investigators aim to study the microvascular and     endothelial function in their population of TLVBS patients.   "
246975|NCT01076959|"     To clarify the following matters:        -  Unknown adverse reactions (especially clinically significant adverse reactions)        -  Incidence and conditions of occurrence of adverse reactions in the clinical setting        -  Factors that may affect the safety and effectiveness of Humira   "
246951|NCT01084759|"     The objective of the study is to determine if men with evidence of progressive prostate     cancer while on chronic androgen ablation of ≥ 1 year duration will exhibit a clinical     response following administration of parenteral testosterone and oral etoposide.      Treatment Plan: Eligible patients will continue on androgen ablative therapy with luteinizing     hormone-releasing hormone (LHRH) agonist (i.e. Zoladex or Lupron) if not surgically     castrated. Patients will receive intramuscular injection with testosterone cypionate at a     dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy). This dose     was selected based on data demonstrating that it produces an initial supraphysiologic serum     level of testosterone (i.e. > 3-5 times normal level) with eugonadal levels achieved at the     end of two weeks. Beginning the day of the testosterone injection, patients will also receive     oral etoposide 100 mg/day in divided doses (50 mg q 12h) x 14 days out of 28 days per cycle.     After 3 months on therapy, patients will have repeat prostate specific antigen (PSA) and     bone/computed tomography (CT) scans to establish the effect of combined testosterone and     etoposide treatment on these parameters (i.e. testosterone effect baseline). Patients with     sustained elevations in PSA ≥ 50% above pre-testosterone treatment PSA levels after the     initial three months of testosterone and etoposide therapy will not receive continued therapy     and will come off study. Patients with PSA levels less than the peak serum PSA level seen     over the three month period (PSA decline) or patients with PSA ≤ 50% of pretreatment baseline     will receive a second 3 month course of monthly testosterone and etoposide therapy until     evidence of disease progression. Disease progression is defined as a PSA increase above the     PSA level obtained after 3 months on testosterone treatment over two successive measurements     2 weeks apart or evidence of new lesions or progression on bone/CT scans compared to baseline     studies. Patients who respond to initial treatment with testosterone and etoposide and then     show signs of progression will have the option of retreatment with testosterone alone after a     period of 3 months or greater off of the original therapy.   "
246952|NCT01084772|"     The objective of this study is to assess outcomes following TKA, utilizing two surgical     techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation     and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at     preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. The secondary     objective of this study is to compare the safety, quality of life, and economic outcomes of     TKA when these two techniques are utilized. This study does not involve treatment or     investigational products, as all components are FDA cleared and are commercially available.   "
246953|NCT01084785|"     The purpose of this study is to determine, by means of DNA and protein analysis, the     relationship between DNA and protein profiles and a number of endpoints, which are important     for the patient such as overall survival and side effects.   "
246954|NCT01084798|"     This is an observational, non comparative, non-randomised, open-label, retrospective, single     centre study planned to collect the data of subjects diagnosed with multiple sclerosis (MS)     as per Poser or McDonald criteria between 1997 and 2007 in Taiwan. The clinical features and     annual relapse rate in the first five years after the onset of disease have been compared     between conventional and optico-spinal MS in the earlier studies. This study aims to     understand the clinical care pathway of MS subjects and facilitate the subject's diagnosis     before converting to MS.   "
246955|NCT01084811|"     The investigators will conduct a descriptive, prospective, three-armed study concerning the     pathophysiology of chronic rhinosinusitis.      In one part of the study the investigators want to investigate the presence of biofilm in     patients with chronic rhinosinusitis both with and without nasal polyps compared with a     control group of subjects without chronic rhinosinusitis. The investigators will also compare     quality of life in the three groups and correlate disease severity in biofilm patients versus     patients where biofilm was not present.      The hypothesis here is that biofilm patients suffers a more severe disease.      In the other arm of the study the investigators will compare the presence of different     biochemical compounds in the three study groups. The investigators specifically want to     investigate matrix metalloproteases and apoptosis-inhibitors with immunohistochemistry. The     investigators may also add other compounds to our test-battery if interesting candidates     surface in the literature during the inclusion period.      The purpose of this part of the study is to investigate candidates for the development of     nasal polyposis.      The investigators plan to include 100 patients suffering from chronic rhinosinusitis with     nasal polyps, and 100 patients with chronic rhinosinusitis without nasal polyps and 30     control subjects.   "
246956|NCT01084824|"     The purpose of the study was to see if liquid nitrogen, a commonly used treatment for warts,     is more effective if it is used alone, or if it is more effective if combined with     cantharidin, a topical treatment also commonly used for warts (verruca vulgaris).   "
246957|NCT01084837|"     Primary outcome measure:        -  Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone          treatment      Secondary outcome measures:        -  Study the speed of response and the response rate (M component in serum and urine          protein) after each bortezomib/dexamethasone cycle        -  Compare the efficacy of the bortezomib/dexamethasone therapy against the therapy without          bortezomib        -  Reversibility of renal failure        -  Predictive value in the light chain determination for response and reversibility of          renal failure        -  Early morbidity (< 2 months)        -  Progression-free survival        -  Overall survival      The safety outcome consists in:        -  Determining the safety and tolerance of VELCADE/Dexamethasone, according to the toxicity          criteria of clinical and laboratory events   "
246958|NCT01084850|"     The purpose of this study is to compare corneal endothelium morphology and central thickness     in type II Diabetes Mellitus and normal subjects with special reference to glycemic status.   "
246959|NCT01084863|"     The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)   "
246960|NCT01084876|"     The purpose of the study is to to demonstrate equivalence   "
246961|NCT01084889|"     The purpose of this study is to determine the influence of Anterior Pelvic Prolapse     Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of     live.   "
246973|NCT01076933|"     Primary purpose : to assess the effect on neuropsychological tasks related to planning of 10     daily sessions of right dorsolateral prefrontal cortex with High-frequency repetitive     transcranial magnetic stimulation (rTMS) on borderline personality disorder (BPD) patients.      Hypothesis : BPD patients receiving 10 sessions of rTMS will have greater improvement in the     average number of move to achieve tasks of the Tower of London, than those receiving sham     rTMS.   "
246976|NCT01076972|"     This non-interventional, post-marketing observational study was conducted to obtain data,     such as safety and effectiveness, from the use of lopinavir/ritonavir (Kaletra) in clinical     practice and investigate the necessity to conduct a follow-up post-marketing clinical study     in Japan.   "
246977|NCT01076985|"     This non-interventional, post-marketing observational study was conducted to obtain safety     data from the use of lopinavir/ritonavir (Kaletra), in clinical practice, in pregnant women     and their children in Japan.   "
246962|NCT01084902|"     Prostaglandin analogs (PGAs) represent a new class of active ocular hypotensive agents and     possess a unique mechanism of action. Many studies suggested that 0.005% Latanoprost was more     effective and safer than other anti-glaucoma medications, such as beta-blockers. It has also     been found to be more effective than other class of anti-glaucoma medications such as     carbonic anhydrase inhibitors and alpha agonists. However data on such comparison is lacking     in Chinese patients. So it is necessary to increase China experience and get clinical data     from China. Besides latanoprost, brinzolamide is known as one of the other ocular hypotensive     agents with less systemic adverse effects, therefore it is selected as the controlled     medication of this study. The administration phase will be 4 weeks because it is long enough     to compare both efficacy and safety of the study drugs and accounting for following-up     conditions in China, it will be easier for the investigators to get enough subjects in a     limited stage if the observation time is shorter.      Before treatment with the study drugs, any previous glaucoma drugs will be washed out. The     minimum washout periods are 5 days for cholinergic agonists, 1 week for adrenergic agonists,     3 weeks for adrenergic β receptor blockers and 4 weeks for PGAS. After washout, the patients     will be randomised send to two parallel study groups: one group will receive latanoprost     0.005% once daily in the evening, the other group receive 1.0% Brinzolamide twice daily.     Randomization will be obtained using a list of random numbers .During the study there will be     four visits: screening, baseline, 2 weeks, and 4 weeks of treatment. The IOP will be measured     with a Goldmann tonometer at 8 am for each visit. The tonometry will be performed before the     administration of the dose of the day in patients treated with Brinzolamide. Three separate     measurements will be taken for each eye and the mean of the three measurements will be used     in the statistical analysis. Best corrected visual acuity and refraction will be determined     and a slit lamp examination, ophthalmoscopy will be performed at all visits.   "
246963|NCT01084915|"     Since a few years the SAGB-VC is used in our clinic. This type of band has a number of     advantages when compared to the earlier versions of the adjustable gastric band (AGB),     reducing the chances on leakage, tube disconnection and port problems. In our clinic the     follow up is strict. All patients are required to follow a special follow-up program in which     the patient is seen 19 times during the first two years after SAGB-VC placement.      This is the first retrospective clinical study of a large study population of >800 patients     in which a SAGB-VC was placed. This study was conducted to evaluate the results and the     efficiency of the SAGB-VC in our clinic.   "
246964|NCT01084928|"     The South Asian Community, people with origins in India, Pakistan, Bangladesh, Maldives,     Nepal, Sri Lanka, or Bhutan, are more likely to get diabetes, get diabetes at younger ages,     and do worse health-wise once they have diabetes than the general population. This study will     test the feasibility and community acceptability of a culturally appropriate lifestyle     intervention for the prevention of diabetes in the South Asian community. The outcomes of     this project could be used to plan larger interventions to prevent diabetes in South Asians,     a rapidly growing segment of the US population.   "
246965|NCT01084941|"     The prevalence of overweight and obesity is increasing among pregnant women in the United     States. More than one-third of women of reproductive age in the US are overweight or obese,     and two thirds of women gain more weight in pregnancy than is recommended by the Institute of     Medicine guidelines. Maternal obesity during pregnancy increases the risk of complications to     both mother and child. Minority women (Blacks and Hispanics) have higher rates of overweight     and obesity when they become pregnant, experience higher rates of excessive weight gain     during pregnancy, and experience higher rates of maternal and neonatal complications after     adjusting for sociodemographic characteristics and comorbidities than Caucasian women.     Epidemiologic studies indicate that lifestyle modification programs based on diet and     exercise are promising approaches in controlling weight gain as well as in preventing type 2     diabetes in populations at risk. We hypothesize that overweight/obese minority women (Blacks     and Hispanics) assigned to a culturally-grounded lifestyle intervention program based on diet     and moderate exercise will result in higher compliance with Institute of Medicine guidelines     for weight gain than women receiving standard care. Such lifestyle modifications should     reduce risk of maternal and neonatal complications. We propose 1) to determine whether a     lifestyle intervention program, based on diet and moderate physical activity implemented     shortly after first recognition of pregnancy, will result in higher compliance with Institute     of Medicine guidelines for weight gain compared to women receiving standard care; 2) to     determine the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation (after     the first 10-12 weeks of intervention) and at 6 weeks postpartum between women in the     lifestyle intervention group and women receiving standard care; and 3) to explore the impact     of the lifestyle intervention on the development of maternal and fetal complications during     pregnancy. By limiting excessive weight gain, the lifestyle intervention program may prevent     the burden of obesity-related complications during pregnancy and reduce risk of subsequently     developing overt diabetes.   "
246966|NCT01084954|"     Validate a simple and cost-effective Nucleic Acid Test for HIV Detection in order to develop     a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection.     Blood samples collected will be assayed using the BioHelix Corporation helicase-dependent     amplification or the Cepheid Xpert HIV-1 Quant Assay. A false negative or false positive rate     of >1.0% would make this test unacceptable as a screening test for HIV viremia.   "
246967|NCT01084967|"     The purpose of this study is to explore the pathogenesis and genetic susceptibility of obese     subjects,providing a convincing argument for further treatment of obesity and metabolic     syndrome.   "
246968|NCT01084980|"     The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with     minimal change nephritic syndrome.   "
246969|NCT01084993|"     RATIONALE:      Transradial coronary stenting is associated with less risk of access site complications and     bleeding compared to femoral approach.      Major bleeding post-PCI is a strong independent predictor of mortality and MACE. Depending of     the antithrombotic regimen and access-site used, bleeding related to access-site represents     50-80% of the cases. Whereas transradial approach minimizes the risks of access-site     bleeding, it has no impact on non-access site bleeding.      Peri-procedural anemia is also an independent predictor of mortality and MACE.      With femoral approach, bivalirudin compared to heparin ± glycoproteins IIb-IIIa has been     associated with a significant reduction in access-site and non-access site related bleeding.      In a post-hoc analysis of patients treated by transradial approach in ACUITY, there was a     trend for non-access site bleeding (organ bleeding) with bivalirudin compared to heparin ±     glycoproteins IIb-IIIa.      HYPOTHESES:      In patients at high-risk of peri-procedural bleeding, bivalirudin ± glycoproteins IIb-IIIa     reduces the risk of bleeding compared to heparin ± glycoproteins IIb-IIIa.      In patients at high-risk of bleeding and undergoing transradial PCI, bivalirudin     significantly reduces the incidence of non-access site bleeding and peri-procedural anemia.   "
246970|NCT01085006|"     Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean     delivery in a double blind randomized placebo controlled trial.   "
246971|NCT01085019|"     The general objective of the study is to investigate the effects of the daily consumption of     spices and herbs for four (4) consecutive weeks in endothelial function and cardiovascular     risk factors of men and postmenopausal women.   "
246972|NCT01085032|"     The study is a two-arm, parallel group, randomized, placebo-controlled, double blind trial,     conducted at four primary health care centers in Aleppo, Syria, to test the efficacy of     transdermal nicotine patch therapy vs. placebo patch therapy, when delivered with behavioral     counseling, on smoking cessation rates.   "
247017|NCT01077518|"     The purpose of this study is to evaluate the safety and efficacy of ofatumumab and     bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to     rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab     treatment.   "
246980|NCT01077024|"     The primary objective of this study is to evaluate the impact of substance-abuse treatment as     usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as     usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether     concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use     outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or     methamphetamine dependence.   "
246981|NCT01077037|"     We are doing a study to assess the impact of including patients in making decision regarding     their own medical care in the emergency department. We will randomly assign them to either     receive a decision aid or usual care. In doing this, we aim to increase patient satisfaction     and safely decrease medical cost.   "
246982|NCT01077050|"     The purpose of this clinical investigation was to determine the safety and effectiveness of     the SciBase III device (Test) designed to help distinguish between malignant melanoma and     benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological     gold standard (Reference).      The purpose of the study is to collect data to support a Pre-market Application(PMA) to     obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical     Impedance Spectrometer.   "
246983|NCT01077063|"     The purpose of this study is to assess in a controlled prospective setting, the safety of the     use of Pleurx catheters and standard therapeutic paracentesis in patients with malignant     ascites.   "
246984|NCT01077076|"     This randomized, crossover study is to evaluate the early effectiveness, defined as effect on     intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter     (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional     purposes are to:        1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the          1st, 4th, and 11th days of dosing with each of the indicated treatments;        2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for          controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing.        3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4          hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid          inhibition at steady-state when administered on the 11th day of dosing.   "
246985|NCT01077089|"     Hospitalized patients are often moved from their rooms to other hospital locations,     particularly imaging facilities. For patients with traumatic brain injury, such movements may     raise the risk of secondary brain injuries. The purpose of this study is to monitor brain     injured patients during transport and to measure the resulting changes in intracranial     pressure. This will allow for documentation of the frequency of secondary injury and help in     understanding their causes.   "
246986|NCT01077102|"     The main purpose of this project is to establish the additional value of eccentric versus     concentric exercise to optimize muscle function in patients with severe COPD. With this pilot     project the investigators expect that an eccentric endurance training protocol adapted to     severe COPD patients will lead to gains in muscle strength, the primary outcome, and cellular     adaptation (muscle morphology and oxidative capacity, mitochondrial respiratory capacity)     when compared to a concentric training approach.      This information will be essential if the investigators want to design and power a randomized     clinical trial that will allow assessing effectiveness of this novel rehabilitation approach.   "
246987|NCT01077115|"     The aim of this work is to evaluate which of the two types of operation (traditional/open and     laparoscopic) has more impact on patients who were operated electively due to their chronic     calculous cholecystitis.   "
246988|NCT01077128|"     Primary objective        -  To evaluate the quality of life of Adalimumab treated patients over a period of 12          months      Secondary objectives        -  To evaluate the long-term efficacy of Adalimumab in patients with moderate to severe          chronic plaque psoriasis as prescribed by the dermatologists in day-to-day clinical          practice and in accordance with the terms of the European marketing authorization.        -  To evaluate changes in patients quality of life according to treatment response over a          12-month period        -  To observe and assess the long term use and safety of Adalimumab as prescribed by the          dermatologist in a normal clinical setting and in accordance with the terms of the          European marketing authorization.   "
247052|NCT01077973|"     This study will compare the ability of a single-dose of a novel ibuprofen formulation to     relieve pain compared to placebo and standard ibuprofen in the treatment of episodic     tension-type headache.   "
247053|NCT01077986|"     In this study the investigators want to determine the activity and safety of concurrent     interruption of the MAPK and PI3K pathways by EGFR and mTOR inhibition in patients with     metastatic pancreatic cancer.   "
246989|NCT01077154|"     Rationale: For women with early-stage breast cancer, bone is a frequent site of relapse, and     most women with advanced breast cancer will eventually develop disease in the bone.      Denosumab, a fully human monoclonal antibody that specifically inhibits RANK ligand, may have     the potential to interrupt the hypothetical vicious cycle of cancer-induced bone     destruction and tumor cell expansion through the bone. It is not yet known if denosumab may     prevent disease recurrence in the bone or in any other part of the body.      Purpose: This randomized phase 3 trial is studying the effect of denosumab to see if it can     prevent disease recurrence in the bone or in any other part of the body, when it is given as     adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease     recurrence.   "
246990|NCT01077167|"     The purpose of this trial is to obtain a pharmacokinetic profile (i.e. amount of drug in the     blood over time) of Omecamtiv mecarbil in patients with stable heart failure.   "
246991|NCT01077180|"     The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol     parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are     refractory to full drug therapy.   "
246992|NCT01077193|"     Up to 45 men and women who meet the entry criteria will undergo the gastric plication     procedure. The study will assess subject excess weight loss (%EWL) following the study     procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.   "
247175|NCT01093859|"     Exploratory phase 1, first in human, open label, non-randomized, single-dose study of     PRX-105, administered intravenously by slow bolus injection to 10 healthy volunteers. The     objective is to evaluate the pharmacokinetic profile of PRX-105 without any significant     physiological effect in healthy volunteers after a single, intravenous microdose     administration.   "
246993|NCT01077206|"     Experimental evidences supported the benefit of Simvastatin in subarachnoid haemorrhage.     Moreover, Simvastatin is a potent agent in achieving low-density lipoprotein (LDL) reduction     with a proven safety profile. However, there is no clinical data to compare the efficacy of     different dosage regimens (namely whether high-dose regimen is better) and related     cost-effectiveness analysis, although biochemical actions and related neuroprotective     mechanisms were thought to be dosage-related. This gap in knowledge is important, on how to     implement the use of statin and interpret different trial results. With these in mind, the     investigators designed the current study.      Hypothesis:      Daily Simvastatin 80mg (high dose) treatment given within 96 hours of the ictus over three     weeks will reduce incidence and duration of delayed ischemic deficits following subarachnoid     haemorrhage when compared to daily Simvastatin 40mg (normal dose) treatment, leading to     improvement in clinical outcome, which translates into advantage in terms of     cost-effectiveness.   "
246994|NCT01077219|"     This study purpose is (1) to develop the new energy expenditure equation; (2) to increase     accuracy of energy cost prediction of cycle ergometer; (3) to find out some dependent     factors.   "
246996|NCT01077245|"     Patients with confirmed C. difficile infection (CDI) who meet eligibility requirements will     be invited to participate. All study patients must receive treatment for CDI with     metronidazole or vancomycin. Enrolled patients will be randomized in a 1:1 ratio to receive     MIYA-BM Fines Granules [Clostridium butyricum MIYAIRI 588 Strain (CBM588)] or a placebo     orally twice a day for 42 days. Patients will be evaluated for safety and clinical outcomes     through Day 180. Occurrence of adverse events (AEs), diarrhea history, and concomitant     medications will be evaluated at scheduled study visits and telephone contacts.   "
246997|NCT01077258|"     Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a     large patient collective under everyday clinical conditions over 2 years.   "
246998|NCT01077271|"     Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against     respiratory syncytial virus (RSV) infection as shown in the IMpact study. Many factors such     as parents' knowledge of burden of respiratory syncytial virus disease or physicians'     satisfaction with Synagis as well as the appropriate use of the product might influence     compliance. The primary objective of this observational study is to evaluate the compliance     to Synagis under daily pediatricians practice conditions in premature infants 33 to 35 weeks     gestational age (wGA). Palivizumab, monoclonal antibody for passive immunoprophylaxis against     severe respiratory syncytial virus disease, was administered according to usual clinical     practice. Compliance was assessed using four criteria: The number of injections per     participant per respiratory syncytial virus season, the body site where injections were     administered, the interval in days between injections, and the dosage per administration.     Originally the study was to include two respiratory syncytial virus seasons but was extended     to a third season.   "
246999|NCT01077284|"     The purpose of this study is to determine the efficacy of febuxostat, once daily (QD),     compared to allopurinol or placebo in patients with excessive amounts of uric acid in their     urine and who have recently had kidney stones.   "
247000|NCT01077297|"     Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the     Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With     Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin     Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines   "
247001|NCT01077310|"     This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus     intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual     of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem     drinking, who are transitioning to the community and seeking treatment to prevent relapse to     alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved     HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol     treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of     reincarceration.   "
247002|NCT01077323|"     The purpose of this research was to assess the absolute and relative incidence of acute     pancreatitis in persons initiating exenatide compared with persons initiating a different     antidiabetic agent, and secondarily, persons without diabetes. This protocol summarizes a     retrospective cohort study using eligibility, pharmacy claims, and medical claims data from a     large US health plan affiliated with i3 Drug Safety.   "
247069|NCT01078194|"     This is an observational study on the efficacy of the secondary placement of the A.M.I Soft     Gastric Band in weight regain or weight loss failure after lap. gastric bypass.   "
247283|NCT01095263|"     The investigators will investigate in a sham controlled design antidepressant effects and     safety of DBS to the superolateral branch of the main medial forebrain bundle (slMFB).   "
247003|NCT01077336|"     Susceptibility testing is commonly employed in patients with bacterial infections in order to     guide rational use of antibiotics; however, the use of antifungal susceptibility testing is     limited due to lack of availability, costs, and delays in receiving results. The goals of     antifungal susceptibility testing should mirror those of antibacterial susceptibility     testing: to predict clinical response or failure. Additionally, susceptibility reports should     be used as a guide for physicians when transitioning patients from parenteral to oral     antifungal agents. Currently, it is unknown whether antifungal susceptibility testing impacts     treatment decisions in hospitals that routinely perform Candida susceptibility testing. The     purpose of this study is to evaluate the changes in antifungal treatment based on in vitro     susceptibility reports and how these decisions affect mortality, recurrence of infection, and     length of hospital stay in candidemia patients.   "
247004|NCT01077349|"     This study seeks to determine if early continuous High Volume Veno-venous Hemofiltration     (HVHF) reduces 30-day all cause mortality in post-cardiac surgery patients developing shock     requiring high doses catecholamines.   "
247005|NCT01077362|"     The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and     safety of ustekinumab in patients with psoriatic arthritis.   "
247006|NCT01077375|"     The objective of this study is to evaluate the safety, tolerability and efficacy of     milnacipran in patients with an inadequate response to duloxetine for the treatment of     fibromyalgia.   "
247007|NCT01077388|"     The e-Care for Heart Wellness study will look at ways to reduce a person's chances of getting     heart disease. We are asking about 100 Group Health members whose electronic medical record     shows they have uncontrolled high blood pressure to be in the study. Having high blood     pressure increases your future risk of heart attacks and strokes.      There are many things you can do to help keep your heart healthy. Examples include lowering     blood pressure and cholesterol, eating healthier, and being more active. Our goal is to test     whether getting care and supportive emails from a dietician helps people do things like this     to lower their chances of having a heart attack or a stroke.      For some people, this study will involve both research and clinical care. About half the     people in the study will receive care related to heart disease prevention from a dietician.     It's a standard clinical practice for dieticians to help people reduce their risk of heart     attacks and strokes. What's different about this study is using emails from a dietician to     help people take steps to improve their heart health.   "
247008|NCT01077401|"     The purpose of this study is to investigate the safety, tolerability, bioactivity, and dose     response of two different dosages (0.5 mg and 2.0 mg) of ranibizumab (RBZ) in patients with     diabetic macular edema (DME).   "
247009|NCT01077414|"     Background:        -  A person s mental state, personal relationships, or spiritual well-being often change in          many ways during or after cancer. Some of these changes can have a life-changing          positive side, called psycho-socio-spiritual or PSS Healing. For example, a person may          feel mentally stronger or more whole than before their cancer.        -  Because researchers are interested in enhancing such experiences in other cancer          patients, there is interest in developing a way to measure PSS Healing that would be          helpful in understanding this phenomenon.      Objective:      - To determine and categorize the characteristics of PSS Healing, which could lead to     development of a psychometric instrument to measure it.      Eligibility:      - Adults who have cancer or have had cancer that was diagnosed after the age of 18 and who     have had at least one strong positive emotional or mental change in relation to the cancer     (e.g., relationships with others, spiritual well-being or faith, thoughts about the meaning     of life, reactions to stress).      Design:        -  The study design does not involve any treatment or counseling.        -  Participants will be interviewed by a research team member. The one-time interview will          last up to 2.25 hours and will be audiotaped and transcribed.        -  Interviews will consist of an in-depth portion to assess the positive changes in          relation to the illness. Participants will then be asked to identify from a list of          short descriptions the ones that best reflect their personal experience of PSS Healing.        -  Transcribed information will be coded and categorized according to standard research          techniques.   "
247010|NCT01077427|"     Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through     an intensified adjuvant treatment with additional application of cisplatin and regional deep     hyperthermia.   "
247011|NCT01077440|"     RATIONALE: Studying samples of semen from cancer survivors in the laboratory may help doctors     learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This phase I research study is looking at the presence of donor-derived DNA in semen     samples form cancer survivors who underwent donor stem cell transplant.   "
247012|NCT01077453|"     This randomized phase I trial studies the side effects and the best dose of letrozole in     preventing breast cancer in healthy postmenopausal women at high risk for breast cancer.     Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The     use of letrozole may keep cancer from forming in healthy postmenopausal women at high risk     for breast cancer.   "
247013|NCT01077466|"     The purpose of this study is to study safety and efficacy of natalizumab treatment of primary     and secondary progressive multiple sclerosis.      This will be done by measuring the effect of treatment on inflammation in the CNS by means of     osteopontin levels in the cerebrospinal fluid (CSF). Safety measures further includes     physical and neurological examination,blood samples and MRI measures of disease activity.   "
247014|NCT01077479|"     The main purpose of this study is to assess the efficacy of metformin in abrogating androgen     deprivation therapy (ADT) induced insulin resistance as measured by homeostasis model     assessment (HOMAIR) in men with non-metastatic prostate cancer.   "
247015|NCT01077492|"     The purpose of this study is to determine wether CT-PET virtual bronchoscopy guided     transbronchial needle aspiration is suitable for the investigation of mediastinal lymph nodes     which is needed for correct staging of lung cancer.   "
247016|NCT01077505|"     This study will be an open-label study to evaluate the effect of albiglutide on the     pharmacokinetics and pharmacodynamics of a standard oral contraceptive regimen (Brevicon).     The primary objective of this study is to demonstrate the lack of effect of albiglutide doses     on the pharmacokinetics of norethindrone and ethinyl estradiol in healthy female subjects.   "
247018|NCT01077531|"     The assessment of otelixizumab in rheumatoid arthritis subjects will provide safety,     tolerability, pharmacodynamic and pharmacokinetic information which will enable the     identification of appropriate safe and well-tolerated dosage regimens to be used in clinical     efficacy studies. This study will consist of a screening phase, followed by a treatment     period where four cohorts of subjects will receive 5 daily intravenous infusions of     otelixizumab. The cumulative dose will increase in each successive cohort and infusion rates     can be adjusted based on signs and symptoms of cytokine release syndrome and to ensure the     specified maximum infusion rate is not exceeded. Serial blood samples will be obtained for     clinical laboratory testing, determination of pharmacodynamic markers, serum otelixizumab PK     parameters, exploratory biomarkers and immunogenicity. Safety and pharmacodynamic data from     the previous cohort(s) will be evaluated prior to dosing subsequent cohorts to ensure safety.     Adverse events, laboratory values, vital signs and ECG's will be monitored closely during     this study. All subjects in the study will undergo long-term follow-up out to 48 months to     monitor patient safety.   "
247019|NCT01077544|"     This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that     are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or     relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity     of nilotinib as secondary objectives.   "
249424|NCT01120795|"     The purpose of this study is to see if treatment of chronic hepatitis C in people who are on     opiate replacement therapy such as methadone or buprenorphine (including patient who still     inject drugs) is safe and effective.   "
247020|NCT01077557|"     This US population-based study will explore the incidence of and risks for fracture among     adults with and without human immunodeficiency virus (HIV) infection. The objectives are to     determine the incidence of fracture among persons with and without HIV infection, compare     risk factors for fracture among persons with and without HIV infection, and to examine the     associations of antiretroviral (ARV) treatment exposure for incidence and risk of fracture     among persons with HIV infection.   "
247021|NCT01077570|"     This study is conducted in Asia. The aim of this observational study is, under normal     clinical practice conditions, to investigate the clinical safety and effectiveness in Chinese     patients with type 2 diabetes who have never received anti-diabetic treatment before.   "
247022|NCT01077583|"     The purpose of this study is to collect urine samples and dating scan information from women     who wish to become pregnant. Urine samples will be tested in the laboratory with the     Clearblue Pregnancy Test and the results correlated with volunteer information.   "
247023|NCT01077596|"     There is a lack of toxicology data on one bupropion metabolite, and limited literature     examining bupropion use and cancer risk. This study evaluates the association between     bupropion exposure and the development of cancer of the prostate, breast, lung, colon/rectum,     urinary bladder, and uterus by comparing the risk of cancer in bupropion users with other     antidepressant users. Because there is no evidence that bupropion is associated with any     particular cancer, we have chosen the six most common cancers diagnosed in the United States     to optimize statistical power/precision for cancer-site specific comparisons. Two US     population-based data resources with automated claims, pharmacy, and tumor registry data are     included in this study. Using a nested case-control design, this study will compare the     incidence of cancer in patients exposed to bupropion with the incidence in patients exposed     to other antidepressants.   "
247024|NCT01077609|"     This is an inception cohort study that analyses data from an administrative medical records     database. The two inception cohorts are: 1) patients initiated on intranasal FP and 2)     patients initiated on another INS (not FP). The candidates for the inception cohorts did not     use any intranasal steroid in the year prior to initiation.   "
247025|NCT01077622|"     Ofatumumab is an IgG1κ fully human monoclonal antibody (mAb) that specifically recognizes an     epitope on the human differentiation antigen CD20 molecule. In vitro and in vivo studies     demonstrated that ofatumumab depletes CD20 positive (CD20+) B cells through     complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity     (ADCC), which results in the antitumour effect.      This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of     ofatumumab monotherapy in chronic lymphocytic leukemia (CLL) patients. Ofatumumab will be     administered intravenously at the first dose of 300mg followed by 7 weekly infusions of     2000mg, followed by 4 infusions of 2000mg at every 4 weeks.      Primary objective of the study (Part A) is to evaluate tolerability, and the study (Part B)     is to assess overall response rate in CLL population.      10 subjects will be enrolled into this study. Subjects will be followed for 48 weeks.   "
247026|NCT01077635|"     Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated     for the treatment of HIV-infected adults, adolescents and children of 6 years of age and     above for use in combination with other anti-HIV medicines. Safety data from two     GlaxoSmithKline (GSK) clinical trials (APV29005 - involving twice-daily doses of FPV with or     without RTV and APV20003 - with once daily dosing of FPV/RTV among 2-18 year olds) indicated     that gastrointestinal events were the most commonly reported AEs, but that the majority of     events were mild and of short duration. Treatment emergent grade 3 / 4 neutropenia was     reported in 20% of children in the APV20003 trial; and neutropenia was identified as a     potential safety concern by the European Medicines Agency (EMEA). The objectives of this     study were to conduct an observational cohort study of the usage and safety of FPV/RTV in     children and adolescents (aged 6 ≤ 18 years) with HIV infection in several European HIV     paediatric cohorts. Data will be collected for 3 years (2008, 2009 and 2010).   "
247027|NCT01077648|"     The purpose of this epidemiologic study is to establish a population-based cohort of women     with advanced stage breast cancer which can be used to quantify the frequency and timing of     brain metastases, and other distant metastases, in this patient population.   "
247028|NCT01077661|"     An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor     the safety and effectiveness of Nebivolol administered in Korean patients according to the     prescribing information   "
247029|NCT01077674|"     Bispectral Index (BIS) and Entropy indices will be compared with each other, and to raw EEG     signals in patients receiving sevoflurane anaesthesia. BIS and Entropy numbers often differ     significantly from each other during surgery, and the reason for this has not been studied in     detail, therefore remaining only poorly understood. BIS and Entropy, together with     multi-channel EEG, will be collected and analyzed later on. Course of anaesthesia and surgery     will be annotated. All relevant information from anaesthesia monitor will be collected on     computer.   "
247030|NCT01077687|"     This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications     that propose to enrich pre-existing resources for schizophrenia in the NIMH Human Genetics     Initiative and to apply genomic methods to further our understanding of the molecular     etiology of the disorder. The overarching aims of this proposal are to quickly and     cost-effectively ascertain a large sample of trio families affected by schizophrenia, and to     discover causal variants for the disorder in the first family-based genome-wide association     study (GWAS) of the disorder. In Taiwan, there is no such kind of policy to support this kind     of GWAS study as it is a very expensive study, including collecting large family samples and     genome-wide SNP scanning. We, thus, collaborate with Professor Ming T, Tsuang and his     extended subcontracted researchers to apply for this project. We, the research team in     Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia. In our recently     completed NIMH-funded Genetic Linkage Study of Schizophrenia (R01MH059624; USA PI: Ming T.     Tsuang; Taiwan PI: Hai-Gwo Hwu), the investigators established a large and efficient     ascertainment network and infrastructure in Taiwan, which will again be utilized and expanded     in the proposed study. Through additional ascertainment within this framework, the     investigators will collect an aggregate sample with adequate power for detecting in a GWAS     those variants that make even small contributions to the risk for the disorder.      The investigators will meet the overarching goals of this project by accomplishing several     Specific Aims, as follows:        1. Rapidly ascertain schizophrenia trio families from ten Taiwanese clinical ascertainment          sites;        2. Supplement NIMH Genetics Initiative collections by sending all clinical data and          biomaterials to the appropriate repositories;        3. Assess the association of schizophrenia with a genome-wide panel of single-nucleotide          polymorphisms (SNPs) and their constituent haplotypes;        4. Analyze quantitative schizophrenia phenotypes such as age at onset ;        5. Perform a genome-wide survey for copy-number variations related to schizophrenia;        6. Test for gene-gene interactions (epistasis); and        7. Test for gene-environment interactions, such as the well-established effect of season of          birth.   "
247031|NCT01077700|"     This is an efficacy and safety study evaluating an experimental treatment for cognitive     deficits in adults with schizophrenia.   "
247032|NCT01077713|"     This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin     + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients     with non-squamous non-small cell lung cancer. Patients will be randomised to receive either     Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or     Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8     of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to     receive Avastin monotherapy. The anticipated time on study treatment is until disease     progression, and the target sample size is <100 individuals.   "
247033|NCT01077726|"     This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases     in breast cancer patients with central nervous system (CNS) progression after whole brain     radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week     cycle. The anticipated time on study treatment is until disease progression, and the target     sample size is <100 individuals.   "
247034|NCT01077739|"     This open-label single arm study will evaluate the efficacy and safety of Avastin added to     XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st     line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv     infusion every 3 weeks) and standard XELOX (Xeloda [capecitabine] plus oxaliplatin)     chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and     leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until     disease progression, and the target sample size is 100 individuals.   "
247035|NCT01077752|"     In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area     around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed     in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 :     intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All     patients will receive parenteral analgesia combining acetaminophen and morphine.   "
247036|NCT01077765|"     Combined antiretroviral therapy (cART) is associated with facial lipoatrophy, which is     potentially stigmatizing for HIV-positive patients. Eutrophill is a 2.5% polyacrylamide     hydrogel obtained by polymerization of acrylamide monomers with an official half-life of 5     years.      Preliminary encouraging results with the use of polyacrylamide hydrogel for reconstruction of     facial lipoatrophy in HIV-infected patients have been previously reported.      The primary objective of the study was to evaluate the long-term efficacy and safety of     subcutaneous facial injections of Eutrophill in HIV-infected patients with severe facial     lipoatrophy as assessed by facial ultrasonography at screening , after 6, 12 and 24 months   "
247037|NCT01077778|"     -  The purpose of this study is to evaluate the diagnostic accuracy of thoracic magnetic          resonance imaging with gadolinium-enhanced, unenhanced and perfusion sequences in          patients with clinically suspected acute pulmonary embolism        -  Thoracic CT angiography (CTA) will serve as reference standard        -  Result of MRI will not interfere with patients' management        -  Untreated patients with negative CTA will have 3-month follow-up to verify they were          free of thrombose-embolic disease   "
247038|NCT01077791|"     Theory of mind (ability to infer others' intention, emotion, etc) is known to be altered in     patients with schizophrenia and its deficit to be correlated with their decreased social     proficiency. We designed a novel cognitive therapy, that makes use of videos, aimed at     learning a better use of contextual information to infer others' intentions. The aim of this     study is to demonstrate, in schizophrenic patients, a quantitative improvement of their     ability to infer intention of others induced by this novel training program. A secondary aim     is to measure the cerebral correlates (MEG, PeV) of this social cognitive function and of its     anticipated improvement.   "
247039|NCT01077804|"     The purpose of these continuing post-licensure studies is to evaluate the long-term     effectiveness of VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)] and to assess the impact     of the vaccine on the epidemiology of varicella and herpes zoster.   "
247040|NCT01077817|"     This is a 2-phase retrospective database study, using both case-cohort and inception     (intention-to-treat) cohort analyses to evaluate any association between oral treatments for     osteoporosis and the risk of esophageal cancer in women.   "
247041|NCT01077830|"     The purpose of this extension is to observe the incidence rates of cancer, total mortality,     and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial     (2004_050, MK0653A-043; NCT00092677).   "
247070|NCT01078207|"     This study will include patients who have major surgery and are at risk for or have been     diagnosed with sleep apnea. The patients will be monitored the night after surgery for     repeating episodes of reduced breathing and oxygen levels. The study will determine if     episodes of decreased breathing are reflected in the oxygen monitor.   "
247071|NCT01078220|"     This is a post-licensure safety surveillance program to detect potential safety signals in     subjects, from the managed care organizations database, who have used GARDASIL™.   "
247042|NCT01077843|"     This study is a population-based cohort of patients with ankylosing spondylitis (AS) from     general medical practices in the UK, France, and Germany with a nested case control component     to assess associations between drug exposures of interest and clinical outcomes relevant to     patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs     (NSAIDS).      The main objective of the study is to describe in European participants with AS: 1) the use     of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of     etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes     of interest relative to non-use of these medications and relative to each other.   "
247043|NCT01077856|"     This study will assess the impact of GARDASIL™ human papillomavirus (HPV) vaccine in the     general female population by utilizing nationwide registry databases in the participating     Nordic countries.   "
247044|NCT01077869|"     In this study, the feasibility of optical imaging and FDG-PET in the evaluation of     radiation-induced mucositis will be evaluated.   "
247176|NCT01093872|"     In this study, we perform an open-label rTMS over the left AC on patients with tinnitus.     Outcome measures will be evaluated statistically. The results will be instrumental in     deciding the efficacy of this technique in a local patient group.   "
249425|NCT01114438|"     The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post     marketing environment in subjects who are obese and have Type 2 Diabetes.   "
247045|NCT01077882|"     'OnderHUIDs' is an educational program (Department of Dermatology, University Hospital, Gent)     for patients with psoriasis and atopic dermatitis. We want to stimulate the patient to     actively participate in their therapeutic approach by enhanced self care. We call the     hypothesis that this program will help the patients learn to cope with their disease and to     be loyal to their treatment, which will result in a better quality of life, better clinical     outcome and cost effectiveness.   "
247046|NCT01077895|"     Intra- abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) are a cause of     organ dysfunction in critically ill patients. IAH develops due to abdominal lesions (primary     IAH) or extra-abdominal processes (secondary IAH). Secondary IAH arises due to decreased     abdominal wall compliance and gut edema caused by capillary leak and excessive fluid     resuscitation. Decreasing intra-abdominal pressure (IAP) using decompressieve laparotomy has     been shown to improve organ dysfunction. However, laparotomy is generally avoided in patients     with secondary IAH due to the risk of abdominal complications.      Acute kidney injury (AKI) is one of the first and most pronounced organ failures associated     with IAH and many patients with AKI in the ICU require renal replacement therapy (RRT). Fluid     removal using continuous RRT (CRRT) has been demonstrated to decrease IAP in small series and     selected patients.      The aim of this study is to evaluate whether fluid removal using CVVH in patients with IAH,     fluid overload and AKI is feasible and whether it has a beneficial effect on organ     dysfunction (compared to CVVH without net fluid removal).   "
247047|NCT01077908|"     The purpose of this study is to evaluate the potential clinical benefit of prophylactic     cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic     hematopoietic stem cell transplantation (HSCT) for reducing recurrent CMV reactivation.   "
247048|NCT01077921|"     An open label, prospective, randomized cross-over phase II study in up to 60 sickle cell     patients who are either homozygous for Hb S or have HbSB0 thalassemia. Initially, each     patient will be treated for 6 weeks with placebo or a standard dose of propranolol (40 mg)     every 12 hrs. This will be followed by a 2-week washout period after which, patients will     receive the other treatment modality (placebo or propranolol).      We Hypothesize that propranolol administered in vivo on a daily basis for 6 weeks (1) will     decrease baseline adhesion to endothelial cells and will substantially abrogate     epinephrine-stimulated adhesion to endothelial cells, as measured in vitro; (2) will improve     biomarkers of endothelial activation and dysfunction; and (3) can be safely used in patients     with SCD. Thus, the use of propranolol in SCD may represent a safe and effective means of     anti-adhesive therapy in SCD.      Study Objectives:      Primary Objective:      • To establish the safety and efficacy of long-term therapy with propranolol as an     anti-adhesive therapy for SCD.      Secondary Objective:      • To evaluate changes in soluble markers of endothelial activation and dysfunction.      Correlative Science Objective:      • To determine whether response to propranolol therapy is associated with polymorphisms in     genes encoding the proteins involved in the upregulation of Sickle Red Blood Cell (SS RBC)     adhesion by epinephrine.   "
247049|NCT01077934|"     The purpose of this study is to define the reliability and accuracy of Near Infrared     Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and     noninjured extremities over time. We hypothesize that this technology, combined with vital     signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing     acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the     adequacy of fasciotomy in patients treated for ACS.   "
247050|NCT01077947|"     Although discography and spinal imaging techniques, either alone or in combination, are     commonly used to diagnose discogenic pain, their exact role in predicting surgical results     are poorly defined. Our aim in this study is to compare the ability of Functional anesthetic     discography (FAD), and Provocative Discography (PD) to diagnose discogenic pain and to     correctly identify the disc levels for the surgical treatment. Proper identification for disc     levels should improve the overall results of surgery for this condition. Patients with     discogenic pain have better outcomes if the disc levels for the fusion surgery are identified     by using FAD compared to similar disc level identification by PD.   "
247051|NCT01077960|"     In Serono Study 24380, the antecedent protocol to Study 25373, patients were randomly     assigned in a 3.0-to-1.0 ratio to Groups A and B. All patients in Group A received     recombinant human growth hormone (Serostim®) 4 mg daily (the induction phase) for the first     12 weeks, and then were re-randomized to receive either placebo or Serostim 2 mg on alternate     days (roughly equivalent to 1 mg daily) during Weeks 12-36 (the maintenance phase). All     patients in Group B initially received placebo from baseline to Week 24, and then received     Serostim® 4 mg daily from Weeks 24 to 36 (Grunfeld, 2007).      In the follow-up Study 25373, any subject who was enrolled in Serono Study 24380 and was     assigned to Group A, who fully completed all study visits without a major protocol violation,     was eligible to enroll to receive re-treatment with Serostim at a dose of 4 mg daily for 12     weeks. During study 25373, safety was monitored by recording of adverse events and     measurement of urinalysis and laboratory blood tests to assess fasting glucose, fasting     insulin, and routine biochemistry and hematology parameters. At Week 12 or at the time of     study termination, subjects underwent re-assessment of body composition via anthropometry     measurements and dual photon absorptiometry (DXA) scanning. In addition, at study     termination, measurements of insulin-like growth factor I (IGF-I), insulin-like growth     binding protein 3 (IGFBP-3), fasting lipid profile, and oral glucose tolerance testing were     obtained.   "
247054|NCT01077999|"     A consistent finding in many studies in patients with operable esophageal and     gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy,     particularly the absence of residual disease in the surgical specimen, is an indicator of     better disease-free and overall survival. Therefore in the investigators trial the     investigators will evaluate the pathologic response of panitumumab in combination with     neoadjuvant chemoradiation as first line treatment of operable adenocarcinomas,     undifferentiated or squamous cell carcinomas of the esophagus.   "
247055|NCT01078012|"     The purpose of the study is together with the BIMOH (NCT01314768) RCT study to evaluate     whether training of GPs in the detection and treatment of medication overuse headache leads     to improved care for these patients as compared to business as usual.   "
247706|NCT01091896|"     The purpose of this study is to determine the effect of pre and intra-operative bevacizumab     injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to     vitrectomy without bevacizumab injection.   "
247056|NCT01078025|"     Transvaginal hybrid procedures are of interest as an available NOTES procedure for the     clinical routine. The gynaecologists` experiences and the available studies report on low     morbidity related to the transvaginal access. However, little is known about the vaginal and     intraabdominal microbial contamination due to the transvaginal approach.      The aim of this cohort study is to evaluate the microbial colonisation and contamination in     patients with transvaginal hybrid and conventional laparoscopic cholecystectomy.      Therefore, pre- and intraoperative microbiological evaluations will be performed in patients     with transvaginal hybrid cholecystectomy and laparoscopic cholecystectomy.   "
247057|NCT01078038|"     This randomized study is a multi-center, randomized, study to compare the efficacy of     sirolimus versus everolimus-eluting stent implantation for long coronary lesions.   "
247058|NCT01078051|"     The purpose of this study is to compare the safety and effectiveness of drug-eluting stent     implantation compared to optimal medical treatment in patients with chronic total occlusion.   "
247059|NCT01078064|"     Gastroesophageal reflux events generally happen during relaxation of lower esophageal     sphincter. This relaxation is a reflex that is triggered by gastric stimuli. The     investigators hypothesize that abnormal relaxation of the gastric wall after a meal may lead     to reflux events. To test this hypothesis, a study was designed to measure the gastric     accommodation in patients undergoing esophageal impedance monitoring.   "
247060|NCT01078077|"     The purpose of this study is to determine if a topical vasodilating cream will improve female     sexual experience.   "
247061|NCT01078090|"     Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a     large patient collective under everyday clinical conditions over a 5-year period.   "
247062|NCT01078103|"     Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and     may be at risk in any intraocular surgical procedure, while others showed no significant     differences between diabetic and non-diabetic corneal endothelium.The purpose of this study     is to investigate the differences in corneal endothelial cell density and morphology in     diabetic patients and normal patients after phacoemulsification with intraocular lens     implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal     endothelial cell changes after phacoemulsification.   "
247063|NCT01078116|"     Evaluation of Health Related Quality of Life (HRQL) is of a paramount importance in assessing     the impact of rheumatoid arthritis on patients' health status, however when costs associated     with rheumatoid arthritis are also taken into account, the information provided may lead to a     more balanced view in analyzing the treatment of the disease.      In accordance with the above, the main objective this study was to evaluate the impact of     adalimumab treatment not only on patients' Health Related Quality of Life but also on the     cost of the disease management. In order to accomplish this the study has been focused on:        1. Estimating the direct and indirect cost incurred by adalimumab treatment.        2. Measuring the Health Related Quality of Life of rheumatoid arthritis patients under          adalimumab treatment.        3. Exploring the cost-utility relationship of rheumatoid arthritis patients treated with          adalimumab by combining the Health Related Quality of Life of rheumatoid arthritis          patients and direct as well as indirect costs due to RA.      More specifically, data related to patients' Health Related Quality of Life and cost     associated with rheumatoid arthritis will be recorded for one-year period, and collected at     four subsequent visits: baseline, month 3, 6 and 12. The visit before starting treatment with     adalimumab will be considered as baseline. This information was used to compare Health     Related Quality of Life and cost data before and after adalimumab initiation and therefore     identify the effect of adalimumab treatment in patients with rheumatoid arthritis.   "
247064|NCT01078129|"     Objectives:      The purpose of this study is to determine the impact of a new Cognitive Remediation Therapy     (CRT) on cognition, social autonomy, symptoms and brain functioning in patients with     schizophrenia.   "
247065|NCT01078142|"     This is a multicenter, open label, single arm, phase I/II study. There will be no placebo     usage within this trial.      Phase I:      Primary: To establish a maximum tolerated dose of the addition of Temsirolimus to a regimen     of Bendamustine and Rituximab (BERT) in patients with relapsed follicular lymphoma and mantle     cell lymphoma.      Phase II:      Primary: To evaluate the ORR in patients with MCL or FL treated with the established BERT     dose Secondary: To determine the complete remission rate, progression free survival rate and     overall survival rate and to investigate safety and tolerability of BERT.   "
247066|NCT01078155|"     This post marketing observational study will be conducted in a prospective, single country,     multicenter format to assess the prevention of generalized bone loss in patients with active     rheumatoid arthritis (RA) treated with adalimumab (Humira®) in pragmatic prescribing     situations. The investigational sites will be centers with experience in the treatment of RA     patients and anti-tumor necrosis factor-alpha (TNF-a) therapy. The investigators will be     rheumatologists authorized by the Czech Rheumatologic Society for prescribing biological     treatment.   "
247067|NCT01078168|"     The trials investigates the changes of cerebral spinal fluid APPSα levels under oral therapy     with acitretin 30mg daily in patients with mild to moderate Alzheimer's disease.The present     study aims to demonstrate an enhancement of the α-secretase activity by acitretin as measured     by increased CSF APPSα levels in human AD. Second, the safety and tolerability of acitretin     in AD patients should be proven.   "
247068|NCT01078181|"     This is a prospective randomized Study comparing Weight loss, Esophageal Motility and Reflux     in lap. Gastric Bypass vs. lap. Banded-Gastric Bypass using the A.M.I. Soft Gastric Bypass     Band (B-Band.   "
247074|NCT01078272|"     This study tests the hypothesis that repeated inflation of a blood pressure cuff on the arm     will improve results of coronary stent implantation by:        -  reducing chest pain and electrocardiogram changes during balloon inflation to place the          stent        -  reducing leakage of heart muscle protein(troponin) into the blood stream after stent          placement, indicated reduced damage to heart muscle during stent implantation        -  increases in molecules in the blood that promote dilation of arteries        -  reduced evidence of heart muscle damage on MRI immediately after stenting        -  improved patient outcomes over six months with fewer adverse cardiovascular events(heart          attack, acute coronary syndrome,renarrowing of the stented artery, heart failure, death,          stroke, transient ischemic attack)        -  improved heart structure and function at 6 months after stenting   "
247075|NCT01078285|"     Despite extensive reports of the benefits of statins in reducing serious cardiovascular     events such as stroke and heart disease in patients with elevated LDL-cholesterol, patients     do not take their medicines regularly as prescribed. Reasons include forgetfulness, lack of     understanding of the seriousness of the disease, and fear of side effects. An intervention     strategy comprising 3-5 minutes of counseling, emotional support and cost-sharing may be     motivational and improve adherence to treatment.   "
247076|NCT01078298|"     Patients with depression tend to have a higher prevalence of smoking as well as increased     severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that     demonstrated its efficacy and tolerability have not included subjects with depression. This     smoking cessation study focuses on the depressed population and will assess the efficacy and     safety of varenicline.   "
247077|NCT01078311|"     Sorafenib improves overall survival and progression free survival in advanced hepatocellular     carcinoma. Wide interindividual pharmacokinetic variability was observed. Data from early     phase trials in solid tumours showed trough sorafenib levels were associated with incidence     of skin rash and hypertension. Rash, hypertension and higher trough levels were moderately     predictive of progression free survival.The trough level of sorafenib may be predictive of     survival and response in patients treated with sorafenib for advanced hepatocellular     carcinoma.   "
247078|NCT01078324|"     The purpose of this study is to study the demographic,laboratory,endoscopic, and outcomes of     ischemic colitis patient presented with severe lower gastrointestinal bleeding compared to     other diagnoses.   "
247079|NCT01078337|"     To determine if MRD (minimal residual disease) can be found in the blood (only) as opposed to     bone marrow in children with ALL (acute lymphoblastic leukemia).   "
247080|NCT01078350|"     This study is designed to collect tissue samples that may aid in the treatment and learning     about various oncology diagnosis.   "
247081|NCT01078363|"     Cardiac transplantation is the ultimate treatment option for patients with end stage heart     failure.      Cardiac allograft vasculopathy remains a leading cause of morbidity and mortality after     transplantation.      Angiotensin converting enzyme inhibitors are used in less than one half of transplant     recipients. Preliminary data suggest that angiotensin converting enzyme inhibitors retard the     atherosclerotic plaque development that is the hallmark of cardiac allograft vasculopathy.     Moreover, this class of drug appears to increase circulating endothelial progenitor cell     number and has anti-inflammatory properties, both of which improve endothelial dysfunction,     the key precursor to the development of cardiac allograft vasculopathy.      The objective of this project is to investigate the role of an angiotensin converting enzyme     inhibitor, ramipril, in preventing the development of cardiac allograft vasculopathy. During     the first month after cardiac transplantation subjects will undergo coronary angiography with     intravascular ultrasound measurements of plaque volume in the left anterior descending     coronary artery. Using a coronary pressure wire, epicardial artery and microvascular     physiology will be assessed. Finally, endothelial function and mediators of endothelial     function, including circulating endothelial progenitor cells, will be measured. Subjects will     then be randomized in a double blind fashion to either ramipril or placebo. After 1 year, the     above assessment will be repeated. The primary endpoint will be the development of cardiac     allograft vasculopathy based on intravascular ultrasound-derived parameters. The second aim     will be to assess the effect of ramipril on endothelial dysfunction early after     transplantation. The final aim is to determine the impact of ramipril on coronary physiology     early after transplantation.   "
247082|NCT01078376|"     The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose     of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.   "
247083|NCT01078389|"     This purpose of this study is to assess the effect of febuxostat, once daily (QD), on joint     damage in patients with elevated serum urate levels and gout.   "
247084|NCT01078402|"     This is a non-interventional, post-marketing, observational study (PMOS) in which Humira     (adalimumab) is prescribed in the usual manner in accordance with the terms of the local     marketing authorization with regards to dose, population and indication. No data currently     exists to characterize patient populations being prescribed Humira in Eastern Europe.     Further, it is important to establish the clinical outcome and tolerability of Humira in     Eastern European patients, as well as their compliance with Humira treatment, in particular     the acceptability of self-injection, which may influence all of the above in routine clinical     practice.   "
247085|NCT01078415|"     The purpose of this study is to evaluate the safety and efficacy of the NanoKnife LEDC System     for the treatment of early-stage hepatocellular carcinoma (HCC).   "
247086|NCT01078428|"     Keloids and hypertrophic scars are a common subject of dermatologic consultations.     Therapeutic management of such conditions remains challenging because of their high rate of     recurrence and lack of curative treatment.   "
247087|NCT01078441|"     This phase II trial is studying how well giving bortezomib together with liposomal     doxorubicin hydrochloride, dexamethasone, and cyclophosphamide works in treating patients     with multiple myeloma that relapsed after autologous stem cell transplant. Bortezomib may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as liposomal doxorubicin hydrochloride, dexamethasone, and     cyclophosphamide, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving bortezomib together with     liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide may kill more cancer     cells.   "
247088|NCT01078454|"     This randomized phase III trial is studying melphalan and dexamethasone to see how well they     work with or without bortezomib in treating patients with previously untreated systemic     amyloidosis. Drugs used in chemotherapy, such as melphalan and dexamethasone, work in     different ways to stop the growth of plasma cells, either by killing the cells or by stopping     them from dividing. Bortezomib may stop the growth of plasma cells by blocking some of the     enzymes needed for cell growth. It is not yet known whether giving melphalan together with     dexamethasone is more effective with or without bortezomib in treating systemic amyloidosis.   "
247732|NCT01092234|"     The trial is designed to evaluate the effectiveness of a newly established Observational unit     at St. Olavs Hospital in terms of readmission rates, compared to the provision of care in     normal/traditional units for defined diagnosis and medical problems.   "
247089|NCT01078467|"     Background:        -  Two important properties distinguish the healing process of skin wounds from that of          wounds of the mucous membranes of the mouth (oral mucosa). Although the skin and the          oral mucosa tissues are similar in nature, oral mucosa have more rapid healing and a          lack of scar tissue formation. However, oral wound healing in general has been poorly          studied, and more information is needed to determine how specific aspects of the oral          environment affect the healing process.        -  Researchers are interested in identifying various factors that contribute to oral wound          healing. Studying this process would help researchers explore procedures to accelerate          the healing of critically-sized oral lesions formed by trauma, surgery, radiation          therapy, infection, and other damage to the mouth. In addition, research into scar-free          healing could be applied to other mucosal sites to promote healing and minimize          unsightly scars that may compromise the tissue.      Objectives:      - To identify the specific factors that enable rapid and nearly scar-free healing of oral     mucosa.      Eligibility:        -  Healthy male volunteers between 18 and 40 years of age.        -  Regular cigarette, cigar, and pipe smokers; occasional smokers who smoke more than 1 day          a week or have smoked in the prior month; users of chewing tobacco or betel nut; and          heavy drinkers (three or more alcoholic drinks per day) will be excluded.      Design:        -  Participants will have a medical history and examination, and will provide blood samples          at the start of the study.        -  Participants will provide oral mucosa samples from the inside of the cheek, taken using          a dermal punch. At the same time, participants will provide skin biopsy samples of          approximately the same size. After the skin and oral mucosa samples are taken,          participants will be divided into three groups for follow-up procedures.        -  Group 1: No further samples will be collected. This group will help document the normal          healing process.        -  Group 2: A second, slightly larger biopsy, which will include the area of the first          biopsy, will be taken on day 3. Both skin and oral mucosa biopsies will be taken.        -  Group 3: A second, slightly larger biopsy will be taken on day 6, in a similar way as          described for Group 2. Both skin and oral mucosa biopsies will be taken.        -  Wounds will be photographed with a digital camera on days 3, 6, 9, 13, and 15; and the          healing will be monitored at the scheduled clinic visits.   "
247090|NCT01078480|"     This study will compare non-operative treatment of displaced midshaft collarbone fractures     with operative treatment using a precontoured titanium plate and screws.      The study hypothesis is that operation will provide better pain relief, faster return to     activities, better function of the involved upper limb, and lower the risk of a non healing     fracture (non union).   "
247091|NCT01078493|"     Wrinkles result from imperfect repair of the dermal layer resulting in loss of collagen     commonly due to ageing, smoking and sun exposure. Platelet rich plasma (PRP) contains a host     of growth factors, which have been used in other clinical trials for various medical     conditions such as tendonitis, and also in surgery such as the surgical repair of facial     defects. Results from these clinical trials suggest that PRP helps in collagen formation and     organisation to promote healing of tissues. This study attempts to document the clinical     effects of intradermal injection of PRP on wrinkles.   "
247092|NCT01078506|"     Intracranial aneurysm (localized dilatation in weakened blood vessel wall) rupture is a     catastrophic disease, with half of the victims died and many of the survivors disabled. There     is currently no data in the literature for the Chinese population concerning the prevalence,     characteristics (location and size) and risk of harboring an unruptured intracranial     aneurysm. In this study, the investigators aim to study the population prevalence and     characteristics (location and size) of intracranial aneurysm in Hong Kong Chinese, and its     cost-effectiveness. The screening is carried out using magnetic resonance angiography (MRA),     with a 3-T magnetic resonance system, which is a well-established non-invasive method for     intracranial aneurysm detection.   "
247093|NCT01078519|"     Maternal intra-partum fever commonly complicates the process of labour. Its occurrence is     often regarded as being synonymous with the presence of chorioamnionitis. This inevitably     results in the administration of antibiotics to the affected mother. Review of the literature     however suggests that this approach is not always appropriate. Non-infective causes of this     condition that are often overlooked include the use of epidural analgesia for pain relief,     normal thermal physiological changes in women not using any form of analgesia and delivery in     an overheated room. Women with certain risk factors such as nulliparity and a long latent     phase of labour are also more prone to developing maternal intra-partum fever. Irrespective     of its aetiology, maternal intra-partum fever carries risks both for the mother and her     unborn child. Putting more thought into the care of these patients will go a long way in     reducing the maternal and neonatal morbidity associated with this complication.The combined     spinal-epidural (CSE) technique has been introduced in an attempt to reduce these adverse     effects. CSE is believed to during labour provide more rapid onset of analgesia than epidural     analgesia, The incidence of fever is significantly lower with CSE technique.   "
247094|NCT01078532|"     This project seeks to improve health care outcomes in complex patients with cardiovascular     disease (CVD) or who are at high risk for developing CVD by promoting patient     self-management. This will be accomplished in 4 diverse, large primary care practices through     the following 3 aims: (1) develop a patient-specific, active component to an existing     electronic PHR directed towards patients with complex illnesses that is designed to reduce     the risk of cardiovascular disease, (2) conduct a randomized controlled trial of the     effectiveness of passive and active PHRs for improving adherence and clinical outcomes of     complex patients in an ambulatory environment, and (3) enumerate the barriers and     facilitators to implementation and use of an PHR among providers and patients in an     ambulatory setting. To accomplish the aim 1, a users group will be assembled to determine     which potential features of an 'active PHR' would be most acceptable and useful to them. To     accomplish the 2nd aim, 1,000 patients with complex chronic disease leading to increased     cardiovascular risk (i.e., CVD or 2 of the 4 conditions of hypertension (HTN), diabetes     mellitus (DM), or hyperlipidemia requiring at least one medication for control) will be     randomized to a passive PHR (n=500), or an active PHR (n=500) at 4 sites where the PHR     currently is installed and in use. Outcomes to be assessed include improvement in control of     risk factors (e.g., blood pressure), frequency of compliance with testing guidelines (e.g.,     annual dilated retinal exams in DM), and clinical outcomes (e.g., myocardial infarction,     hospitalizations). Aim 3 will be accomplished by surveying all participants using the PHR,     along with nurses and physicians at the study sites, and by conducting focus groups of PHR     participants, nurses, and physicians to determine the most useful features of the PHR and to     barriers and facilitators of use.   "
247095|NCT01078545|"     The purpose of the study is to determine the influence of GnRH (gonadotropin releasing     hormone) analogue - Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine) administration     on intensity of lower urinary tract symptoms (LUTS) in patients with diagnosed locally     advanced and/or metastatic prostate cancer and LUTS.   "
247096|NCT01078558|"     This a five year, post-marketing observational study to follow-up patients with rheumatoid     arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA     (adalimumab).   "
247284|NCT01095276|"     The investigators hypothesized that dornase alpha, administered twice a day (BID) by in-line     nebulizer, would improve oxygenation, compliance, and time to extubation in adult patients     receiving mechanical ventilation.   "
247229|NCT01094561|"     The aim of our study is to evaluate the utility of Secretin-Stimulated Magnetic Resonance     Cholangiopancreatography (S-MRCP) in detecting carcinoma and precancerous lesions in patients     with a significant family history of pancreatic adenocarcinoma. Our hypothesis is that S-MRCP     is superior to traditional computed tomography (CT) or magnetic resonance imaging (MRI) in     detecting early pancreatic neoplasms, and approaches the accuracy of endoscopic ultrasound     (EUS).   "
247097|NCT01078571|"     Adalimumab is one of the pharmacological treatments for rheumatoid arthritis (RA) of more     recent marketing authorization, and as a result of this, there are only efficacy and safety     data from clinical trials with controlled conditions.The study will evaluate the safety and     effectiveness of adalimumab in the common clinical practice of RA treatment in Spain, with     several types of patients showing concomitant treatments or diseases and compliance. Among     the tumor necrosis factor antagonists safety studies, adalimumab safety has been the less     investigated in the common clinical practice because of, as a result of its recent marketing,     it was not included in the BIOBADASER (Data Base for Biological Products in Spain,     Rheumatology Spanish Society), Biologic Products Database of the Spanish Society of     Rheumatology ) in which was determined an association between infliximab therapy and the risk     of developing active tuberculosis. To ensure the maintaining of the strict common physician     practice (no prescription induction), and following the recommendations of the SER (Sociedad     Española de Reumatología, Spanish Society of Rheumatology) consensus documents, it will be     selected only those patients that were already in treatment with adalimumab (HUMIRA),(except     patients involved in clinical studies with Adalimumab), and had shown good response, or those     that fulfilled treatment indication in accordance with the SER recommendations and following     the Summary of Products Characteristics of adalimumab (HUMIRA).   "
247098|NCT01078584|"     The in-MAU-tion study is conducted to determine the percentage of hypertensive participants     with or without diabetes reaching CHEP (Canadian Hypertension Education Program) defined     blood pressure targets. Additionally, the study assesses change in renal function     (microalbuminuria, estimated glomerular filtration rate) in hypertensive participants treated     with trandolapril (Mavik®) and examines patient satisfaction with trandolapril (Mavik®)     therapy.   "
247099|NCT01078597|"     A key challenge in the management of patients with Rheumatoid Arthritis (RA) is the early     identification of patients that are at risk of developing a severe and destructive disease. A     better understanding of prognostic factors such as anti-CCP and anti-MCV biomarkers, is     needed in order to better identify patients with early Rheumatoid Arthritis that are at risk     of developing aggressive diseases. At the present time the prevalence of one such biomarker,     namely anti-MCV, is unknown in an Irish Rheumatoid Arthritis population. This study will     establish the prevalence of anti-MCV in such a population.      A second challenge in the management of Rheumatoid Arthritis patients is the determination of     the best treatment strategy tailored to individual patient's needs. In routine practice,     treatment approaches are based on the patient history and the availability of clinical     parameters, such as a positive anti-CCP status, which is associated with worst prognostics.     At the present time, the impact of a positive anti-CCP status on patients' management has not     been formally studied in Ireland The proposed study will provide data on the prevalence of     anti-MCV in an Irish RA population and the use of anti-CCP and other clinical parameters     currently used in routine care. In addition, the present study will evaluate the impact of     the known anti-CCP status on patients' management. Associations between the anti-CCP and     anti-MCV status and clinical outcome measures will be assessed.      The results from the present study will have significant implications not only for the     individual patient but also from the societal perspective, since it will enhance the overall     understanding and applications of different treatment approaches based on individual     patients' profile.   "
247100|NCT01078610|"     Safety and effectiveness, quality of life and work productivity of Humira in patients with     psoriatic arthritis in clinical routine.   "
247101|NCT01078623|"     The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations     of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol     fumarate, all administered BID in patients with stable, moderate to severe COPD.      Every treatment period is 14-days long and there is a 7-days wash-out period in between them.     The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow     up contact 14-days after last treatment dose.   "
247102|NCT01078636|"     The purpose of this study is to build upon the information obtained in the original     Alzheimer's Disease Neuroimaging Initiative (ADNI1), to examine how brain imaging technology     can be used with other tests to measure the progression of mild cognitive impairment (MCI)     and early Alzheimer's disease (AD). ADNI-GO seeks to define and characterize the mildest     symptomatic phase of AD, referred to in this study as early amnestic MCI (EMCI). This     information will aid in the early detection of AD, and in measuring the effectiveness of     treatments in future clinical trials.   "
247103|NCT01078649|"     The purpose of this study is to determine the safety profile and the maximum dose of Debio     1143 (AT-406) that can be given to humans. This study is also designed to measure how much     Debio 1143 (AT-406) gets into the blood stream (pharmacokinetics), and how Debio 1143     (AT-406) interacts with proteins related to cancer that the drug is targeted to affect     (pharmacodynamics).   "
247104|NCT01078662|"     To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed     genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response   "
247105|NCT01078675|"     This study is being carried out to see if the study medication, rosuvastatin, is effective in     treating familial hypercholesterolaemia in children and adolescents, and to determine the     long term (over 2 years) safety, tolerability and efficacy of the study medication in these     patients.      This study will also measure levels of drug in the blood and see how well it is tolerated.     This is known as pharmacokinetic (PK) analysis.      At baseline only a small number of patients will participate in a single dose PK phase over     24 hours.      In order to see if this medication works, a control group of healthy siblings will help the     researchers to compare certain results.   "
247106|NCT01078688|"     Evaluation of the frequency of limitation of activity, depending on gender and age-group, in     patients with persistent asthma consulting a general practitioner   "
247107|NCT01078701|"     The purpose of this phase IIa trial is to evaluate the immunogenicity of a single dose of     GHB11L1 administered by liquid nasal spray for vaccination against influenza A (H1N1) virus.      This study is also performed to assess safety, tolerability and pharmacokinetics (shedding)     of a single dose of GHB11L1 administered by liquid nasal spray.   "
247108|NCT01078714|"     The purpose of this study is to determine if a treatment by bumetanide presents an efficiency     at the level of the neuronal maturation in the autism   "
247109|NCT01078727|"     Improving upper extremity movement and function in patients with stroke has been one of the     primary goals for patients and rehabilitation professionals. Thermal stimulation (TS) had     been first found by a domestic research group to be effective to facilitate sensory and motor     recovery in patients with stroke within a month. However, the immediate and long-term effects     of TS and the mechanism of brain plasticity in patients with stroke for more than three     months (golden recovery stage) remain unknown. Thus, we will design a single-blind randomized     controlled trial to investigate the immediate and long-term effects of TS in patients with     stroke at subacute and chronic stages.   "
247110|NCT01078740|"     This is a pilot study. The purpose of the study is to facilitate the development of a new     biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) function using rectal     tissue.   "
247111|NCT01078753|"     This is multi-center, randomized, placebo-controlled, parallel-group, double-blind,     dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin     orally lyophilisate for the treatment of nocturnal enuresis with decreased nighttime urinary     osmolality.   "
247112|NCT01078766|"     The combination of the constraint-induced movement therapy (CIMT) method as a complement to     hand arm bimanual training (HABIT) will improve the frequency and quality of cooperative hand     use and function in children with hemiplegic CP.   "
247113|NCT01078779|"     A randomised controlled trial to determine the efficacy of chloroquine for the prevention of     influenza   "
247114|NCT01078792|"     To determine the possible association of prothrombin fragments 1+2 elevation with incidents     of pulmonary embolism in patients with COPD exacerbation.   "
247115|NCT01078805|"     The purpose of this study is to evaluate the long-term effectiveness, safety, and     tolerability of FORTEO in a larger, more diverse real world population than studied in     clinical trials   "
247116|NCT01078818|"     Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary     bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The     purpose of this study was to compare the clinical efficacy of intravenous and oral iron in     anaemia and the impact of the iron on the transfusion rate in postoperative cardiovascular     surgery under extracorporeal circulation.   "
247117|NCT01078831|"     The purpose of this study is to examine changes in ventilation and airway pressures during     conventional bronchoscopy of intubated patients.   "
247118|NCT01078844|"     The purpose of this study is to see if memantine is helpful in managing problematic symptoms     in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise     specified (NOS).   "
247119|NCT01078857|"     Neurological dysfunction is a common complication of late stage chronic kidney disease (CKD)     and peripheral nerve system is often involved in such complication. Sensory disturbances such     as paresthesia and hypoesthesia are the predominant symptoms in uremic polyneuropathy and it     is traditionally thought the uremic polyneuropathy mainly involve large-diameter sensory     nerves. However in uremic patients the abnormal thermal thresholds, the sensory symptoms like     numbness, burning, paradoxical heat, cold or freezing, and pain, and the frequent symptoms of     autonomic dysfunction suggest that small-fiber neuropathy should be a clinical entity in     patients of CKD. But there are still few investigations with emphasis on the changes of     small-fiber nerves in CKD, and little is known about the characteristics and mechanism of     small-fiber neuropathy in CKD. Skin biopsy with evaluation of epidermal nerve density and the     morphology of epidermal nerves and the subepidermal nerve plexus is an effective and     minimally invasive test for assessment of small-fiber neuropathy. Contact heat evoked     potential (CHEP) recording the brain responses evoked by contact heat stimuli on the skin is     a non-invasive technique to investigate the thermo-nociceptive pathways mediated by     small-fiber nerves. In the current study, we will use an integrated approach by combining the     skin biopsy, quantitative sensory testing, autonomic function tests, and CHEP to investigate     the pathological, psychophysical and physiological aspects of small-fiber neuropathy in     patients of CKD. The aims of the current study is to address the following issues: (1) the     changes of small fiber nerves in uremia and CKD of different stage; (2) the correlation of     skin innervation with clinical manifestations, thermal thresholds, and autonomic function;     (3) the influence of dialysis therapy, the type of dialysis therapy, or renal transplantation     on the small fiber neuropathy in uremia; (4) the roles of blood chemical substances, metals,     and endocrine profiles on the development of small-fiber neuropathy; (5) the relationship     between the small-fiber neuropathy and pruritus or restless leg syndrome; and (6) the     pathological and physiological correlates of painful symptoms by skin biopsy and CHEP in CKD     related neuropathy. The results of the study will provide important insights in the     understanding of the pathogenesis, and the prevention and new treatments of small-fiber     neuropathy in CKD.   "
247120|NCT01078870|"     The project is a double-blind, randomized, placebo controlled clinical trial comparing 3     groups of schizophrenic subjects, who have no less than moderate degree of negative symptoms     and carry the homozygous risk genotype (TT) of NRG1-P3, each group having 30 individuals,     treated by add-on with escitalopram 10-20 mg/day, duloxetine 30-60 mg/day, and placebo. The     treatment duration is 8 week. The investigators will evaluate the Positive and Negative     Symptom Scale (PANSS) at baseline, Day 14, Day 28, Day 42, and Day 56. The primary outcome of     interest will be the differences of averaged reduction of negative symptom scores among 3     groups and an average decrease of 2 or more in the negative symptoms will be indicated as     improvement.   "
247121|NCT01078883|"     The purpose of our study is to investigate the association between respiratory muscle     performance, functional capacity, dyspnea, anxiety/depression symptom, 1-year respiratory     morbidity rate, and 1-year mortality in patients with primary stage IIIb and IV lung cancer.   "
247122|NCT01078909|"     The purpose of this study is to determine the lowest effective dose of EPA + DHA (300, 600,     900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the     inflammatory response to in vivo and ex vivo endotoxin challenge as measured by the     production over time of several inflammatory markers.   "
247123|NCT01078922|"     This is a phase II open label study that looks at the efficacy and toxicity of Ofatumumab     monotherapy in patients with relapsed and/or refractory diffuse large B-cell lymphoma     (DLBCL). Patients will receive weekly infusions of Ofatumumab of 1000 mg each for 8 weeks     (induction phase) followed by continuing the study drugs every other week in subsequent     cycles (maintenance phase). Each 4 weeks of therapy will be calculated as one cycle.     Treatment will continue until disease progression, toxicity, patient's withdrawal, or     investigator's discretion.   "
247172|NCT01093820|"     Hypothesis:      Based on available pharmacokinetic data from healthy volunteers we hypothesize that the     administration of a cumulative dose of 210μg of the continuous erythropoietin receptor     activator, Mircera® (Roche), during 3 months post percutaneous coronary intervention (PCI)     does not result in hemoglobin (Hb) levels >15 g/dl in patients with ST-segment elevation     myocardial infarction (STEMI)      Design:      Prospective, open label single center pilot study   "
247173|NCT01093833|"     The purpose of this study is to compare two continuous glucose sensors, one placed     subcutaneous (under the skin) and one placed intradermal (in the skin) over 12-14 hours.   "
247124|NCT01078935|"     Fifty patients will get probiotics (109 bacteria [L. acidophilus, B. bifidum, S.     thermophilus, L. rhamnosus, L. casei] in 2 capsules) and half will get placebo (2 capsules     that look the same like the probiotic capsules and will contain microcrystalline cellulose,     artificial brown color, magnesium strearate, and silica dioxide). The patients and the staff     will be blinded to the identity of the study medications.      Each patient and volunteer will get the study medication for 6 weeks and will be evaluated     twice - before enrollment and after 6 weeks of treatment. Routine clinical management will     continue - with regular treatment as needed.      Each individual will be studied for changes in biochemical inflammatory and immunological     markers and changes in flow medicated diameter that will be measured by the brachial artery     method (that is evaluating endothelial function). Every patient will be evaluated for his/her     ability to produce endothelial progenitor stem cells (EPCs).   "
247125|NCT01078948|"     The project will investigate the use of a novel neuromodulatory technique, transcranial     direct current stimulation (tDCS) in the treatment of patients with major depressive     disorder.      Hypothesis 1: Active tDCS will improve depressive symptomology to a significantly greater     degree than sham treatment.      Hypothesis 2: Active tDCS will be well tolerated and free of major side effects.   "
247126|NCT01078961|"     This research study involves the use of two investigational drugs: sorafenib and bortezomib.     Sorafenib is designed to stop the growth of cells caused by changes associated with cancer.     Bortezomib is designed to stop cancer cells from getting rid of waste products. This causes     the cells to build up toxic levels of waste that leads to cell death. In the laboratory, the     combination of sorafenib and bortezomib has been shown to fight cancer cells better than     either drug alone. We are looking to determine if the combination of sorafenib and bortezomib     is a safe treatment for patients with advanced melanoma. The effectiveness of this     combination will also be assessed.   "
247127|NCT01078974|"     Pomalidomide is a newly discovered drug that may stop cancer cells from growing abnormally.     Pomalidomide may also stimulate the immune system to fight the cancer cells and possibly     improve the effectiveness of dexamethasone and rituximab to fight the Waldenstrom's     Macroglobulinemia (WM) cancer cells. This drug have been used in multiple myeloma and     information from these other research studies suggests that Pomalidomide may help to reduce     or prevent the growth of cancer cells.   "
247128|NCT01078987|"     The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing     dermopathy (NFD)/nephrogenic systemic fibrosis (NSF).   "
247129|NCT01091090|"     Millions of individuals with chronic pain smoke and our preliminary research suggests that     currently available strategies to help people quit smoking may not be effective for     individuals with chronic pain. This is important in that smokers with chronic pain have worse     pain-related health outcomes compared to nonsmokers with chronic pain. The primary aim of     this research project is to develop a smoking cessation intervention for specific use in an     outpatient clinical setting for smokers with chronic pain.   "
247130|NCT01091103|"     This study is being conducted to determine the effect of enzalutamide on the androgen     signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify     potential predictors of response or resistance to therapy.   "
247131|NCT01091116|"     The purpose of this study is to determine whether intra-articular (knee joint) administration     of MEN16132 is effective reducing the pain from knee osteoarthritis.   "
247132|NCT01091129|"     The purpose of this study is to determine whether treatment by the miraDry System can safely     reduce the severity of axillary hyperhidrosis (excessive underarm sweating).   "
247133|NCT01091142|"     Primary objectives: To assess the safety and tolerability of ascending doses of NP001     compared to placebo in subjects with ALS.      Secondary objective: To explore the effects of NP001 on biomarkers potentially relevant to     ALS.   "
247134|NCT01091155|"     The performance of the ColonRing™ will be comparable to or better than the reported     performance of staplers.   "
247135|NCT01091168|"     In metastatic breast cancer (MBC) patients who have already received anthracyclines, taxanes,     antimetabolites and vinca-alkaloids and have developed drug resistance to these drugs,     therapeutic options are very limited. Alkylating agents showed a modest activity in     pretreated metastatic breast cancer. This phase III trial will compare the effectiveness and     the safety profile of vinflunine to an alkylating agent of physician choice in MBC patients     who have exhausted anthracyclines, taxanes, antimetabolites and vinca-alkaloids.   "
247136|NCT01091181|"     Women who are to undergo their first Cesarean and have cervical dilatation 5 cm or more are     randomized to having the hysterotomy 2 cm below or above the bladder insertion on the uterus.     They are followed up with a transvaginal scan of the uterus 6 - 9 months after the Cesarean     to assess the appearance of the Cesarean scar in the uterus.   "
247137|NCT01091194|"     This is a randomized controlled trial which will include approximately 50 heart transplant     recipients 1-8 years after heart transplantation. The intervention and follow up period is 1     year. The primary purpose is to investigate if systematic, high intensity, interval-based     aerobic exercise training results in a greater improvement of exercise capacity (measured by     VO2peak) than previously shown in heart transplant recipients.   "
247138|NCT01091207|"     With discovery of KIT (CD117) mutations and the advent of KIT tyrosine kinase inhibitor     imatinib, there has been substantial improvement in overall survival in patients with     advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib showed     activity as second-line therapy in GIST patients after failure with imatinib. However,     virtually all patients will eventually progress or become intolerable after imatinib and     sunitinib. In preclinical models, sorafenib inhibits KIT activity and cell growth of     imatinib-resistant tumors. The objective of this multi-center, non-randomized phase II study     is to evaluate the safety and activity of sorafenib given as third-line therapy for GIST.   "
247139|NCT01091220|"     The primary objective of this study is to evaluate the effect of certolizumab pegol (CZP) on     the quality of sperm obtained from healthy male volunteers.   "
247174|NCT01093846|"     A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled     study to assess the difference in the rate of recurrent exacerbations in Behçet's patients     with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care     immunosuppressive therapy   "
247140|NCT01091233|"     Patients with liver cirrhosis are at risk for development of renal failure, usually after a     precipitating event such as infection or bleeding. This form of renal failure has a high     morbidity and mortality and may be partly caused by increased intra-abdominal pressure     secondary to ascites. Recent studies have shown that paracentesis (and the resulting     decreased IAP) can increase urinary output and decrease renal arterial resistive index in     patients with hepatorenal syndrome (a very pronounced form of renal failure in cirrhosis     patients). The aim of this study is to evaluate the influence of Paracentesis on     intra-abdominal pressure and kidney function in critically ill patients with liver cirrhosis     and ascites across a wider range of kidney function. Kidney function will be evaluated using     several estimates of glomerular filtration rate and measures of kidney injury i.e. cystatin     C, serum NGAL, creatinine clearance, urinary output and renal arterial resistive index.   "
247141|NCT01091246|"     The primary objective of this study is to demonstrate the immunologic noninferiority of     Q/LAIV to FluMist in children 2 to 17 years of age.   "
247142|NCT01091259|"     The purpose of the study is to evaluate the efficacy and toxicity of irinotecan in the     treatment of women with recurrent epithelial ovarian cancer or primary peritoneal cancer when     combined with bevacizumab.   "
247143|NCT01091272|"     The purpose of the study is to evaluate the safety and tolerability of PF-04995274 after     administration of a single dose to healthy volunteers, and to evaluate the plasma drug     concentrations after single dose in healthy volunteers.   "
247144|NCT01091285|"     A randomized controlled double blinded study to investigate whether a specially designed     double balloon catheter is more efficient than a foley catheter for cervical ripening and     induction of birth.      160 women with singleton term pregnancies with un ripe cervix and no contraindications for     catheters will be included and randomized to either double og single balloon catheters for     cervical ripening. Efficacy wil be assessed at removal of the catheter, measured by the     amount of women where the cervix has become ripe enough for amniotomy.      Our hypothesis is that double balloon catheters will give a greater amount of women where     amniotomy upon catheter removal is possible. Secondary outcomes as time from induction till     birth, vaginal deliveries and complications during or after birth for the mother or child     will also become recorded.   "
247145|NCT01091298|"     This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus     vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at     the highest possible viral concentration in 0.5 mL of vaccine.   "
247146|NCT01091311|"     Multicentric study, open label, uncontrolled phase IV in 30 patients with meibomian glands     dysfunction .      Its objective is to Collect information from patients and ophthalmologists specialized in     ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.      This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.      Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two     uses per day) and complete a questionnaire every two days during the first week and then once     a week the next two weeks.   "
247147|NCT01091324|"     The investigators test the renal and cardiovascular protective effects dextromethorphan and     silymarin on patients with the proteinuric chronic kidney diseases, who enrolled in our     clinical trial, had progressing kidney diseases and merit aggressive anti-inflammatory     therapy.   "
247148|NCT01091337|"     To compare the efficacy and safety of inhaled procaterol (Meptin Air) versus inhaled     salbutamol as metered dose inhaler (MDI) reliever of acute exacerbation of asthma not in     imminent respiratory failure.   "
247149|NCT01091350|"     The aim of this study is to validate that an effect compartment concentration for loss of     consciousness (LOC) was varied according to different Keo value.   "
247150|NCT01091363|"     Nicotine dependence is very common among Asian Americans; yet, research on understanding and     treating nicotine dependence in this group is almost nonexistent. The proposed study is a     first attempt to develop a smoking cessation program that is tailored to Korean-culture     specific aspects. It is proposed that Korean Americans who receive a culturally tailored     smoking cessation program will be more likely to have prolonged abstinence at 12-month     follow-up than their counterparts who receive brief cessation counseling. Subjects in both     arms receive nicotine patches for 8 weeks. Self-reported abstinence is validated with exhaled     carbon monoxide and salivary cotinine tests.   "
247151|NCT01091376|"     Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable,     non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still     controversial.The objective of this study was to evaluate the efficacy and toxicity of a     concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation     treatment.   "
247152|NCT01091389|"     This study aims at investigating the role of autonomic modulation of AF. Therefore, totally     thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be     studied against PV isolation alone. Two groups of patients (paroxysmal AF with or without     structural heart disease and persistent AF with or without heart disease) of 110 patients     each will be studied.   "
247153|NCT01091402|"     One of the proposed mechanisms in CU is autoimmunity. It was shown by a positive response to     autologous serum skin test (ASST)in almost half of chronic urticaria (CU) patients. IL-18     also play a role in autoimmune disorders. The investigators aim was to investigate the     relationship of ASST and IL-18 in CU and respiratory allergic diseases.   "
247168|NCT01093768|"     This research study investigates the effects of oxytocin and vasopressin on brain activity in     adults with Autism Spectrum Disorders using functional magnetic resonance imaging (fMRI).      Background:      - Oxytocin and vasopressin are two hormones produced in the brain. Both hormones can     influence activity in brain regions such as the amygdala that are involved in social and     emotional processing. There is evidence suggesting that oxytocin and vasopressin may be     implicated in autism spectrum disorders (ASD).      Objectives:      -Here, we use functional magnetic resonance imaging (fMRI) to assess the effects of oxytocin     and vasopressin on brain activity in adult healthy volunteers and adults with ASD.      Eligibility:      - Right-handed individuals between 18 and 40 years of age who either have been diagnosed with     autism, Asperger s disorder, or Pervasive Developmental Disorder- Not Otherwise Specified     (PDD-NOS), or are healthy volunteers.      Design:        -  This study requires 3 outpatient visits to the NIH Clinical Center in addition to a          screening visit. Each visit will last about 2.5 hours. Participants may not smoke          cigarettes or drink alcohol or caffeinated beverages for 12 hours before each visit.        -  During each visit, participants will receive a nasal spray that contains one of the          following: oxytocin, vasopressin, or placebo. Participants will receive a different          spray at each visit.        -  After using the nasal spray, participants will have an MRI scan of the brain while          performing tasks with social and emotional stimuli.        -  After the MRI scan, participants will complete questionnaires about mood and reaction to          the tasks, and will remain in the clinic until the effects of the study medication have          worn off.        -  Participants will be contacted 1 day after each MRI scan for follow-up purposes.   "
247154|NCT01091415|"     The incidence of distal radius fracture (DRF) increases with age, and thus, because of     improving life expectancies, these fractures are set to become more common. Fractures of the     distal radial metaphysis are known to be strongly related to osteoporosis, and as a result,     the management of distal radius fractures in elderly patients is beset with difficulties.      Recently, more aggressive fracture fixation in the elderly has become a topic of interest, in     the hope of increasing the rate of recovery to preserve the ability to live independently.     Many elderly patients remain active well into their eighth and ninth decades, for example,     some pursue activities, such as, golf and tennis, on a daily basis. The introduction of volar     locking plating system has increased this interest. This system, which uses a fixed angle     principle, has been proposed to be effective at maintaining good anatomic reduction, even in     the elderly. However, there is a still concern about remaining metaphyseal defect after     reduction of the osteoporotic DRF.      Injectable calcium phosphate bone cement (CPC) has been used to augment the remaining     metaphyseal defect after fracture reduction including DRF, specially in osteoporotic old     patients. The purpose of this randomized, prospective study was to investigate that     additional CPC augmentation has any benefit over volar locking plate fixation in unstable DRF     patient who is older than 65. The null hypothesis is that there is no difference of wrist     functional outcomes, radiographic outcomes, and complications between treatment of volar     locking plate alone and calcium phosphate bone cement as well as volar locking plate in     unstable DRF patient who is older than 65.   "
247155|NCT01093599|"     The Mindfulness Training for Smokers study follows a randomized controlled design with 240     total participants. Both the study group and the control group will be enrolled in the     Wisconsin Tobacco Quit Line and will receive four weeks of nicotine patches. The control     group will receive the Quit Line intervention alone where as the study group will receive the     Quit Line intervention plus the Mindfulness for Smokers Intervention. The Mindfulness for     Smokers Intervention provides four weeks of instruction in mindfulness meditation followed by     four weeks of participation in a weekly meditation group. The principal hypothesis for the     study is that Mindfulness for Smokers plus the Quit Line will lead to significantly higher     rates of smoking cessation at 6 months than the Quit Line alone.   "
247156|NCT01093612|"     RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help     doctors to plan a better treatment      PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid     (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with human epidermal     growth factor receptor 2 (HER2)-positive breast cancer.   "
247157|NCT01093625|"     The purpose of this study is to evaluate the effect of an investigational silicone hydrogel     soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle     wearers.   "
247158|NCT01093638|"     The study will evaluate the effect of oral formulation of insulin on preterm infants, born     between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and     exclusion criteria established in this protocol.   "
247159|NCT01093651|"     We will test the safety of a new class of anti-diabetes compounds (DPPIV-inhibitors) in     people living with HIV. Future trials will examine efficacy for treating diabetes and     reducing cardiovascular disease risk in people living with HIV.   "
247160|NCT01093664|"     This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with     regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who     have received the vaccine within the clinical study AFF002.   "
247161|NCT01093677|"     LIM-0705 will gain results on the effects of LIM-0705 on Male Subjects with Impaired Glucose     Tolerance   "
247162|NCT01093690|"     The objective of this study is to assess the efficacy and tolerability of metoclopramide     added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.   "
247163|NCT01093703|"     The purpose of this study is to identify and manage factors related to blood pressure control     that impact organ function and survival in kidney transplant recipients. Loss of the     circadian (relating to a 24-hour rhythm) blood pressure pattern is common in kidney     transplant recipients and is associated with poor allograft kidney function. It is still     unclear if restoring the normal day-night blood pressure (BP) pattern will translate into     better allograft outcome. Although studies in patients with and without chronic kidney     disease indicate that restoration of the normal nocturnal (night) dipping in BP is possible     by changing the timing of the BP medications to cover the overnight period (chronotherapy),     this has not been tested in kidney transplant patients.   "
247164|NCT01093716|"     Null hypothesis: There will be no significant difference in the change in craving parameters     between right and left prefrontal high frequency rTMS in patients with alcohol dependence.   "
247165|NCT01093729|"     Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design.     Five ascending dose cohorts are planned.   "
247166|NCT01093742|"     -  Study Design             -  Randomized, Double-blind, Placebo-controlled, escalating single-dose design.             -  Four ascending dose cohorts.             -  In each cohort, subjects will be randomized to receive a single dose of HM10560A or               placebo (negative control).        -  Objectives             -  The primary objective of the study is to assess the safety and tolerability of               single escalating subcutaneous doses of HM10560A in healthy male subjects.   "
247167|NCT01093755|"     The investigators hypothesize that intensive acid suppression with a long acting high potency     proton pump inhibitor (PPI) drug dexlansoprazole will lead to a greater decrease in levels of     inflammatory mediators (compared to conventional PPIs) in the esophagus, which could     potentially lead to decreased recurrence of intestinal metaplasia following endoscopic     ablation.   "
247169|NCT01093781|"     The goal of this proposal is to conduct a pilot study to access the antiproteinuric effect of     aliskiren in patients with idiopathic membranous nephropathy. Patients will be treated for 3     months with aliskiren aiming to achieve the maximum tolerated dose and blood pressure (>100     but <125 mmHg systolic BP >75% of the readings).   "
247170|NCT01093794|"     This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin     50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of     corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be     bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and     metformin.   "
247177|NCT01093885|"     Systemic sclerosis is a chronic autoimmune connective tissue disorder with no universally     accepted disease modifying regimen. Recruiting patients for systemic sclerosis treatment     studies is difficult due to the limited availability of such patients and furthermore the use     of a placebo arm is often deemed unethical due to the poor survival of diffuse systemic     sclerosis patients.      Long-term controlled trials examining functional outcomes and survival from novel therapeutic     agents for systemic sclerosis are often difficult to undertake because of costs, rarity of     the disease and ethical issues with the use of a true placebo. Open label single center     studies while inferior to multicenter placebo controlled studies, have helped establish the     benefits of certain pharmaceutical agents in systemic sclerosis, and while not universally     accepted as disease modifying agents, have been used with some success to treat systemic     sclerosis.      The hypothesis on which we are basing this study is that an endothelin receptor antagonist     and disease modifying agent with antifibrotic properties will have additive influence on     fibrosis, inhibit cellular and humoral hyperactivity and interfere with smooth muscle     proliferation in the vessel wall. The combination of these two agents will also be the first     regimen to address the heterogeneity of scleroderma manifestations including ILD, pulmonary     arterial hypertension and skin manifestations   "
247178|NCT01093898|"     This study will measure the brain activity of adolescent substance abusers while they make     decisions about their preferences to receive smaller, immediate rewards versus larger delayed     rewards. The investigators expect that patterns of brain activity while engaged in this     decision making task will predict response to treatment among adolescent substance users. The     investigators expect to use the results of this study to develop more effective treatments     for adolescent substance abuse   "
247179|NCT01093911|"     To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657   "
247180|NCT01093924|"     This is a 5-year community-based participatory research intervention study with the goals of     1) conducting a more definitive study of weight loss maintenance in Native Hawaiians and     Pacific Peoples and 2) identifying the aspects of the community-academic partnership that     fosters a co-learning and co-equal environment.   "
247181|NCT01093937|"     Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated,     expansive and irritable mood, often alternating with periods of significant clinical     depression. People with Bipolar Disorder are typically heavy smokers who have difficulty     quitting, and this is associated with significant tobacco-related medical illness and death.      The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the     safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder.     This medication is the latest first-line pharmacotherapy for smoking cessation and has been     shown to be efficacious for smoking cessation, but has not yet been systematically studied in     persons with Bipolar Disorder.   "
247182|NCT01093950|"     A white light scanner can more accurately measure body contouring subjects than standard     anthropomorphic methods.   "
247183|NCT01093963|"     The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant     (lisdexamfetamine) in the adjunctive treatment of bipolar disorder.   "
247184|NCT01093976|"     The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in     individuals with obsessive-compulsive disorder (OCD) or the obsessive-compulsive spectrum     disorders, trichotillomania (TTM) or pathological skin picking (PSP). Fifteen patients with     OCD, TTM, or PSP will receive 12 weeks of open-label treatment with dronabinol. The     hypothesis to be tested is that dronabinol will be effective and well tolerated in patients     with these disorders. The proposed study will provide needed data on the treatment of a     disabling disorder that currently lacks a clearly effective treatment.   "
247185|NCT01093989|"     The research questions to be answered by this study are:        1. Is treatment with iron more effective at improving anemia if given at the time of a          malaria episode or 1 month after the episode?        2. Which treatment timing is associated with more malaria episodes - 1 month delayed          treatment or immediate treatment at the time of malaria?        3. Does timing of iron treatment affect later thinking processes and behavior?   "
247186|NCT01094002|"     Objectives: To compare the benefits of structured occupational therapy intervention by a     single geriatric therapist with the benefits of the conventional treatment model in the     functional recovery of patients admitted to an acute geriatric unit.      Design: Non-pharmacological randomised clinical trial. Setting: Acute Geriatric Unit,     Albacete, Spain. Participants: The trial included 400 patients admitted consecutively over 6     months to an acute geriatric unit for acute illness or exacerbation of a chronic medical     condition. Participants were randomised to the occupational therapy intervention or     conventional treatment model group; 198 patients received occupational therapy. All patients     completed the study. The mean age was 83.5, and 56.8% were women.      Interventions: Needs assessment, iatrogenic prevention, retraining in basic and instrumental     activities of daily living, assessment of need for technical aids, instruction for primary     caregiver in patient mobilisation techniques, and structured social and occupational     motivation as per protocol in three groups of patients (cardiopulmonary disease, stroke, and     other conditions) 5 days a week, 30 to 45 minutes a day over the entire hospital stay.   "
247187|NCT01094015|"     The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain     during hysteroscopy diagnostic practice.   "
247214|NCT01094366|"     Many woman undergoing a surgical abortion receive a paracervical nerve block for pain     reduction, in which lidocaine (a numbing medication) is injected around the cervix. These     injections numb the cervix and possibly the lower part of the uterus. However, the injection     can be uncomfortable and it is not well known whether it is effective in reducing pain. The     purpose of this study is to determine the level of pain women experience with a surgical     abortion and the effect that paracervical block might have on that pain.   "
247230|NCT01094574|"     Previous studies have shown that the beta-adrenergic system plays a role in processing pain     and the expression of hyperalgesia. Recent studies have investigated the analgesic effects,     and potential anti-hyperalgesic effects (using a model of opioid induced (OIH) hyperalgesia)     of propranolol, a beta adrenergic antagonist. We plan to further investigate the analgesic     effects, and the potential anti inflammatory effects, of propranolol and compare those     effects to alfentanil, an opioid of known effect, and placebo   "
247188|NCT01094028|"     During the first hours that follow the birth of the baby (third and fourth stages of labor),     complications are common and can threaten the mother's life. The most common complication is     postpartum hemorrhage (PPH), which remains a leading cause of maternal mortality (25.0%)     especially in developing countries .Three to five percent of deliveries are complicated by     PPH and is 50 times more common in developing countries. Retained placenta is an another     complication of third stage of labor. It complicates 0.1-2 % of deliveries . Without prompt     treatment, women are at high risk of hemorrhage. At present, treatment is by manual removal     of placenta, which needs an operating theatre, a surgeon, and an anaesthetist—facilities that     are often unavailable to women in resource-poor settings. As a result, this condition has a     case fatality rate of nearly 10% in rural communities.      The length of the third stage of labor, and its subsequent complications depends on a     combination of the length of time it takes for placental separation and the ability of the     uterine muscle to contract. Principal management of the third stage of labor is aimed at     reducing the time of delivery of placenta so minimising serious adverse effects, such as     blood loss and retained placenta. Active management of the third stage of labor, which     includes prophylactic injection of 10 units of oxytocin within two minutes of birth, early     clamping of the umbilical cord and controlled cord traction (CCT), is recommended by WHO for     PPH prevention .      Umbilical vein oxytocin injection directs the treatment to the placental bed and uterine     wall, resulting in an earlier uterine contraction and placental separation. However, very     limited published literature is available, which evaluated the effect of umbilical vein     oxytocin injection in routine practices for active management of the third stage of labor.     The purpose of this investigation was to find out the beneficial effect of adding     intraumbilical vein oxytocin in reducing the blood loss during third and fourth stages of     labor, length of third stage of labor, and reduction in the incidence of manual removal of     retained placenta.   "
247189|NCT01094041|"     The specific hypotheses are:      Gluten supplementation for four weeks increases small intestinal permeability and accelerates     colonic transit in patients with irritable bowel syndrome with diarrhea (IBS-D) or functional     diarrhea (FD) who are HLA-DQ2 positive.   "
247190|NCT01094054|"     The overall aim is to determine the mechanism(s) by which common bariatric surgical     procedures alter carbohydrate metabolism. Understanding these mechanisms may ultimately lead     to the development of novel interventions for the prevention and treatment of Type 2 diabetes     and obesity.   "
247191|NCT01094067|"     Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate     that a single infusion of tezosentan has minimal effect on blood pressure in patients with     pulmonary arterial hypertension, treated with endothelin receptor antagonists,     phosphodiesterase-5 inhibitors or a combination of both.   "
247192|NCT01094080|"     In this study, the suitability of an infant formula with a modified content of protein and     fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.      Primary hypothesis to be tested is: an infant formula with a modified protein content is non     inferior compared to a standard infant formula in respect to the growth of healthy term     infants.   "
247193|NCT01094093|"     The purpose of this study is to assess the safety and tolerability of AMG 139 following     single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and     subjects with moderate to severe psoriasis (PsO).   "
247194|NCT01094106|"     Infiltration of a local anesthetic into the surgical wound is a simple method to strive to     control postoperative pain after surgery. In the investigators institution, this method is     used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover,     the cost of the single use elastomeric pump used with this procedure is clearly higher than     the costs of other routinely used analgesic methods.      According to the investigators observations, infiltration of a local anesthetic into the     surgical wound after caesarean section seems to reduce the need for rescue analgesics.     However, the scientific evidence of the efficacy of this technique is weak. The investigators     decided to conduct a prospective, controlled, randomised, double blind trial on this topic.      The hypothesis is that wound infiltration with local anesthetic will reduce postoperative     pain and opioid consumption after caesarean section without major adverse effects.   "
247195|NCT01094119|"     Recently, a novel posterior heating system has been developed that provides enhanced pressure     relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this     FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal     surgery. The investigators therefore propose to test the hypothesis that intraoperative     distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body     forced-air warming in patients undergoing open major abdominal surgery under general     anesthesia.      Secondary hypotheses include that:        1. intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air          warming        2. final intraoperative core temperature is non-inferior with PerfecTemp than upper-body          forced-air warming        3. final intraoperative core temperature is superior with PerfecTemp than upper-body          forced-air warming.   "
247196|NCT01094132|"     Precancerous lesions of the cervix occur frequently and are treatable. This justifies a     population-based screening program. Following an abnormal Pap smear, patients are referred     for a colposcopic exam to confirm the presence/stage of disease and select appropriate     treatments. Unfortunately, these approaches do not detect all lesions or can sometimes give     'false positive' results (resulting in overtreatment). We are testing a device called a     'multispectral digital colposcope' to determine whether it is more effective at detecting     precancerous cervical lesions than existing tools. Success in our study will make diagnoses     more accurate and reduce the costs associated with unnecessary treatments.   "
247197|NCT01094145|"     In the study at hand, six patients with light to moderate Alzheimer's disease will be     enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert.   "
247198|NCT01094158|"     Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol     versus the placebo arm following three month treatment.      Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin     resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol     and the placebo arms.   "
247199|NCT01094171|"     The purpose of this study is to assess reactogenicity and safety of simultaneous     administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK     Biologicals' DTPa-vaccine Infanrix vaccines in healthy children in Russian Federation in     their first year of life according to National Calendar of Prophylactic Immunisation of     Russian Federation.   "
247228|NCT01094548|"     Tecemotide (L-BLP25) is believed to induce a Mucinous glycoprotein 1 (MUC1)-specific T-cell     response after vaccination. The primary purpose of this study is to ascertain whether     vaccination with tecemotide (L-BLP25) induces a MUC1-specific T-cell response in slowly     progressive or chemotherapy naive multiple myeloma subjects.   "
247285|NCT01095289|"     The objective of this study is to evaluate the electromyographic activity of masseter muscle     during deglutition in laryngectomized subjects.   "
247200|NCT01094184|"     This open-label, multi-centre study will evaluate the safety, tolerability and effect on     disease progression, survival time and Karnofsky performance status of bevacizumab (Avastin)     in combination with taxane monotherapy in female patients with oestrogen-, progesterone- and     HER2-receptor negative (triple-negative) breast cancer. Patients are eligible to participate     in this study if they have not received prior chemotherapy for metastatic breast cancer and     in the investigator's opinion, require combination therapy for treatment of their disease.     Patients will receive taxane (weekly paclitaxel or three-weekly docetaxel) and bevacizumab     (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks as intravenously infusion). The treatment     will continue until disease progression. The target sample size is < 100 patients.   "
247201|NCT01094197|"     Individuals who experience traumatic injury often require blood transfusion. In some     individuals who receive blood after an injury, white blood cells from a person who donated     blood may remain in the body for years, a condition known as microchimerism. This study is     designed to examine a group of people who are known to have long-term microchimerism and,     through analysis of their blood, determine whether there is evidence that the microchimerism     involves blood stem cells that can become any type of blood cell (red blood cells, white     blood cells, or platelets) and that might be a permanent part of the body.   "
247202|NCT01094210|"     The purpose of this trial is to evaluate the anticaries remineralizing potential of a     toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially     available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model,     whereby approved human participants will wear an orthodontic appliance fitted with an enamel     specimen for the duration of a leg (28 days). There will be two test legs.   "
247203|NCT01094223|"     The broad, long-term objective of the current research is to improve treatment for stimulant     use disorders by augmenting traditional relapse prevention therapy with innovative     meditation-based strategies to promote affect regulation skills. Based on Mindfulness-Based     Cognitive Therapy for depression (Segal, Teasdale, & Williams, 2002), Marlatt and colleagues     recently developed a manualized intervention for the treatment of substance using     populations: Mindfulness Based Relapse Prevention (MBRP). The specific aims of this research     are 1) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting     and retaining individuals for a large scale study and to determine the effect size of MBRP     relative to a health education (ED) control group in stimulant users receiving contingency     management (CM). Both MBRP and ED participants will be assessed at baseline, treatment-end,     and 1 month post-treatment. 2) To test the impact of MBRP compared to ED on negative affect,     stimulant use, and health care outcomes. 3) To evaluate the differential effects of MBRP     versus ED on HIV-risk behavior of participants, and 4) To examine potential mechanisms of     action of MBRP, including reductions in stress reactivity and biological indicators of     arousal such as blood pressure and heart rate. The investigators hypothesize that MBRP will     be more efficacious than ED in reducing negative affect and stimulant use. Further, the     investigators expect that MBRP will produce greater reductions in HIV-risk behaviors, stress     reactivity, and arousal, and these changes will be associated with substance use outcomes.     MBRP incorporates specific substance-focused cognitive therapy techniques with an additional     emphasis on mindfulness skills. By providing coping skills to address affect regulation and     stress reactivity, two important factors in stimulant relapse, MBRP may provide a promising     augmenting strategy for the treatment of stimulant users.   "
247204|NCT01094236|"     The goal of the Playground supervision clinical trial is to see if playground management     skills are improved, after implementing the school-wide behavior management program.   "
247205|NCT01094249|"     The purpose of this study is to evaluate the potential effect of multiple oral doses of an     extended release formulation of paliperidone on the pharmacokinetics (blood levels) of     valproic acid (VPA) in patients with schizophrenia, bipolar I disorder, or schizoaffective     disorder.   "
247206|NCT01094262|"     The purpose of this study is to evaluate pain relief, safety, and tolerability of a new     treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in     comparison to a standard pain treatment and placebo.   "
247207|NCT01094275|"     Clopidogrel, an inhibitor of ADP induced platelet aggregation and activation, is one of the     most commonly used drugs in patients with cardiovascular disease. The specific aim of the     proposed study is to determine whether the interaction between proton-pump inhibitors (PPIs)     and clopidogrel is dependent on CYP2C19 haplotype.   "
247208|NCT01094288|"     This is an open-label, multicenter, Phase 1 study that will evaluate the safety and     tolerability of MLN8237 given orally in combination with docetaxel as a treatment for     advanced solid tumors to determine tolerable doses and schedules of MLN8237 and docetaxel to     be evaluated in future Phase 2 studies.   "
247209|NCT01094301|"     Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person     has had a stroke. The SPR System is an investigational device that is being studied for the     relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes     a Trial Stage (where a temporary system is used to see if the subject may benefit from this     type of therapy) and may include an Implant Stage (where a small device is implanted under     the skin in the chest). The SPR System delivers mild electrical stimulation to the muscles in     the shoulder where the subject feels pain. This research study will evaluate the effect of     electrical stimulation on shoulder pain.      Individuals who are over the age of 21, who had a stroke at least six months ago, who     experience shoulder pain, and have tried other therapies for their shoulder pain, may be     eligible to participate in the first stage of the SPR System. Subjects meeting the specified     success criteria at the conclusion of the SPR Trial Stage who experience a return of pain     within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR     Implant Stage). This research study lasts a little over 3 years and may include 17 visits to     the study doctor and at least 8 telephone calls from study staff.   "
247210|NCT01094314|"     The purpose of this study is to compare two culture media.   "
247211|NCT01094327|"     Patients with focal segmental glomerulosclerosis (FSGS) who progress rapidly to end stage     renal disease (ESRD) are at highest risk for development of recurrence of proteinuria     following kidney transplantation. This study will look at serum specimens pre and post     transplant, as well as kidney transplant specimens pre and post reperfusion to identify where     the defects has occured that results in recurrence of proteinuria in a given kidney     transplant.   "
247212|NCT01094340|"     This is a 24-week, randomized, double-blind, placebo-controlled study of the effect of     thalidomide and placebo on CSF (cerebral spinal fluid) and plasma biomarkers in patients with     mild to moderate Alzheimer's disease. This study will evaluate the effects of 24 weeks of     treatment with Thalidomide on plasma biomarkers.   "
247213|NCT01094353|"     A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot     with minisling.   "
247215|NCT01094379|"     Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic     gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result,     reduced postoperative pain, shorter hospital stay and rapid return to normal activity.     Although reduced, however, pain is still substantial and constitutes the main clinical     problem after laparoscopic cholecystectomy, especially for planned day case procedures.      Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all     instruments are inserted through the same umbilical incision. The single incision     laparoscopic surgery (SILS) technique for cholecystectomy has been proved to be feasible and     safe by several studies.      The purpose of the study is to compare postoperative pain and operating time, nausea,     vomiting, tissue damage, pulmonary function, cosmetic result, quality of life between SILS     and standard laparoscopic cholecystectomy.   "
247216|NCT01094392|"     Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but     severe side effects to the treatment is thrombosis in or outside the central nervous system.      The aim of this study is to investigate and describe the influence on the coagulation     parameters during prolonged treatment with asparaginase.      Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it     possible to prevent these.   "
247217|NCT01094405|"     The purpose of this study is to evaluate the efficacy (clinical benefit rate) of MVA     EBNA1/LMP2 vaccine in patients with persistent, recurrent or metastatic nasopharyngeal     carcinoma, and its impact on disease progression.   "
247218|NCT01094418|"     The purpose of this study is to evaluate the distal sensory nerves of the feet, namely, the     dorsal sural, medial dorsal cutaneous and medial plantar nerves, in patients with impaired     glucose tolerance and diabetes mellitus type 2 and compare these parameters to those from     healthy participants.   "
247219|NCT01094431|"     The purpose of this study is to study the most common etiologies of uncomplicated fever     diseases among children under five years of age in rural Zanzibar.   "
247220|NCT01094444|"     The study aims to explore the benefit of topical vitamin K3 lotion for the     reactivation/rephosphorylation of EGF-receptor in the skin and the possible reduction in     cutaneous side effects of EGFr-inhibition.      Primary aim: The possible reduction of cutaneous side effects: folliculitis, dryness and     redness of the skin.      Secondary aim: To explore any possible side effects of topical vitamin K3 lotion.      Methods: 36 patients with metastatic colorectal cancer or metastatic head and neck cancer     allocated to treatment with chemotherapy and biweekly cetuximab. Two equally sized areas of     at least 10x10 cm on the back or chest of the patient is marked. Patients receive in a double     blinded procedure placebo lotion on one side and vitamin K3 lotion on the other side. The     treatment may last for a maximum of two months and the patients are followed biweekly with     photos, VAS-scores, questionnaires and CTCAE estimations. The patient will be able to take     weekly photos at home during the weeks they are not seen at the outpatient clinic. During the     treatment all other skin products or antibiotics is allowed and will be carefully registered     by the health care professionals in the outpatient clinic.      The patient may enter the trial in two different ways: 18 patients start treatment with study     lotions at the time they start treatment with cetuximab. The other 18 patients start     treatment with study lotions when folliculitis appears.      Patients are asked for 1.5 mm skin biopsies of both study areas of the skin before start of     treatment and after 4 weeks of treatment with placebo lotion and vitamin K3 lotion. These     biopsies will be investigated for EGFr, phosphorylated EGFr and other central downstream     mechanisms. The biopsy part of the study is optional for the patient.   "
247221|NCT01094457|"     Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of     ischemic events and can be detected by laboratory tests. This multicenter, randomized study     is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double     clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary     stenting.   "
247222|NCT01094470|"     The purpose of this study was to investigate the effects of gait training on ground level     with partial body weight support (BWS)in individuals with stroke during overground walking     with no BWS.   "
247223|NCT01094483|"     The primary hypothesis of this study is that concomitant multiple-dose administration of PN     400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose     aspirin (81 mg), as measured by serum thromboxane B2 inhibition.   "
247224|NCT01094496|"     The major purpose of this study is to examine the anti-tumor activity of the CDX-1307 vaccine     regimen when it is given before and after bladder cancer surgery. The study will also provide     information about the safety of the vaccine regimen when given in combination with     chemotherapy, and how it affects the immune systems.   "
247225|NCT01094509|"     Cognitive aging and cognitive decline are important public health concerns in an aging US     population. The investigators will conduct a randomized controlled trail among healthy older     adults to assess effects of several innovative activities on remediation of age-related     cognitive decline.   "
247226|NCT01094522|"     Study Population:      Neonates, infants and children from birth to 5 years of age undergoing cardiac surgery with     CPB.      The use of methadone to provide analgesia may be increasing due to advantages compared to     other commonly used opioid analgesic drugs. While efficacy of methadone has been reported in     adults, there is a paucity of information in neonates and infants. In the latter population,     fentanyl and morphine are most commonly used for opioid analgesia following major surgery,     while methadone is frequently used for weaning of opioid dependent and tolerant patients, in     spite of the paucity of knowledge of methadone pharmacology in this population. There are     several clinical problems associated with fentanyl and morphine, and methadone may offer     superior efficacy with fewer side effects than these agents. We propose to study the     pharmacokinetics (PK) and pharmacodynamics (PD) of methadone in neonates and infants in the     intensive care unit following cardiac surgery.   "
247227|NCT01094535|"     The aim of this study will be to determine whether secretin-enhanced MRCP (S-MRCP) as well as     traditional magnetic resonance imaging (MRI) of the pancreas will allow the investigators to     quantify the pancreas' ability to secrete hormones as well as digestive enzymes, both before     and after surgery. The investigators hypothesize that S-MRCP will provide a novel     non-invasive measure of pancreatic function.   "
247231|NCT01094587|"     This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis     closure with a randomized control trial. The parameters of this trial were determined using     our retrospective study as pilot data. Primary outcome measures will be time on ventilator     and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome,     length of hospital stay and the associated rate of complications, including bowel resection,     sepsis, and death.   "
247232|NCT01094600|"     The aim of our study is to evaluate S-MRCP, in comparison to direct pancreatic function, to     measure pancreatic exocrine function in patients who have symptoms suspicious for     insufficiency. We hypothesize that S-MRCP imaging parameters will correlate well with the     direct pancreatic exocrine functioning.   "
247233|NCT01094613|"     The study is designed to evaluate the clinical efficacy and safety of daily treatment for 12     weeks of oral administration of a delayed release, locally delivered 6MP (mercaptopurine)     drug (80 mg), as compared to standard Purinethol (at a dose of 1-1.5 mg/kg/body weight), in     alleviating the clinical, immunological and mucosal signs and symptoms of moderately active     Crohn's Disease   "
247234|NCT01094626|"     The aim of the study is to evaluate the utility of secretin-enhanced MRI (S-MRI) in detecting     and measuring pancreatic lesions in patients with known adenocarcinoma or Intraductal     papillary mucinous neoplasm (IPMN) lesions. The hypothesis is that S-MRI is superior to MRI     without secretin enhancement (N-MRI) in increasing tumor conspicuity, allowing for improved     identification and more accurate measurement of lesions or precursor lesions in the pancreas.   "
247235|NCT01094639|"     The purpose of this study is to examine the role of gum disease in affecting the long term     prognosis of renal patients. This disease if untreated causes inflammatory response     throughout the body. If the subject has gum disease, he/she will be randomly assigned to one     of the two treatment groups. The study investigates what happens to inflammatory markers in     blood and saliva after you are treated for gum disease.   "
247236|NCT01094652|"     The Dietary Guidelines for Americans recommend that children and adolescents consume     whole-grain products often; at least half the grains should be whole grains. Few, if any     studies, examine the benefit of whole grains on the health of adolescents. The purpose of     this study is to determine if adolescents eating diets rich in whole grains vs. diets rich in     refined grains (i.e., a typical diet) have improved markers of digestive and immune health.   "
247237|NCT01094665|"     The primary objective of this study is to evaluate the safety and feasibility of Magnetic     Resonance Image (MRI) guided focal prostate cancer laser thermal ablation in males, ages     40-80 with biopsy confirmed early clinical stage prostate cancer (T1c or T2a) with an     identifiable lesion on mutliparametric MRI, with a Prostate Specific Antigen (PSA) of <     15ng/ml, who have not yet undergone pelvic radiation or hormonal deprivation therapy.   "
247238|NCT01094678|"     The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter     single-arm study enrolling patients in Europe, Asia, and North America with de novo or     restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal     artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.   "
247239|NCT01094691|"     To prospectively test whether the detection of three-dimensional, cast-like polyomavirus     aggregates, termed Haufen, in voided urine samples can serve as an accurate biomarker of     intra-renal disease, i.e. polyoma-BK-virus nephropathy (PVN). We want to correlate the     detection of 'Haufen' with histologic findings made in renal biopsies as well as signs of     polyomavirus activation, i.e. viremia and viruria. The prospective study is designed to     further validate our retrospective findings (manuscript in press, J Am Soc Nephrology) and     more specifically to correlate 'Haufen' shedding with the histologically confirmed course of     PVN.   "
247240|NCT01094704|"     Direct measurement of mucociliary and cough clearance (MCC/CC) has been used as a biomarker     in cystic fibrosis (CF). Additional knowledge of the performance of this biomarker is needed     to inform exploratory clinical trial design in support of programs to develop new inhaled     therapies for CF. We hypothesize that MCC/CC measurements can be used to determine the     durability of action of agents like hypertonic saline (HS) which increase epithelial lining     fluid height.   "
247241|NCT01094717|"     The hypothesis of this study is that excimer (308-nm UVB) laser added to either tazarotene     0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone.      The primary objective of this study is to compare the improvement of psoriatic plaques with     and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded     fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD. The primary endpoint will     be the comparison between the change in NPF score of plaques treated with excimer laser and     those treated with sham treatment.      The secondary objectives are to compare the number of excimer light treatments and time     necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with     acitretin 25 mg PO or tazarotene gel 0.1% QD, and to evaluate adverse events related to     combinations of the study treatments.   "
247242|NCT01094730|"     The purpose of this study is to compare lens surface characteristics and comfort between an     experimental contact lens and a marketed contact lens.   "
247243|NCT01094743|"     The purpose of this study is to compare visual acuity and redness of eyes between a prototype     contact lens and an already marketed contact lens.   "
247269|NCT01095081|"     Prospective, non-interventional, multi-center study. The observation period for each subject     covers the treatment period with Gadovist®. For each patient, the treating physician or nurse     documents demographics, medical data, safety parameters and treatment signs and symptoms at     the visit. Patients with severe renal impairment will be followed-up after 3 month by phone     call from the investigator if in line with routine practice. Data audit/monitoring by source     data verification will be done in a subset of sites and patients   "
247270|NCT01095094|"     RATIONALE: Ritonavir and lopinavir may stop the growth of gliomas by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase     II trial is studying how well giving ritonavir together with lopinavir works in treating     patients with progressive or recurrent high-grade glioma.   "
247707|NCT01091909|"     The purpose of this study is to evaluate clinical healing after dental extraction and the     occurrence of surgical complications in patients with type 2 diabetes and compare with     non-diabetic patients or control, taking into account laboratory data such as blood count,     glycated hemoglobin (HbA1) and immunological profile of the patients.   "
247244|NCT01094756|"     Central dopamine is thought to play a significant role in obesity. In support of this idea,     animal studies and one human positron emission tomography (PET) study have found reduced     postsynaptic D2-like receptor availability in the striatum in obesity, with lower D2 receptor     availability associated with higher weight. In addition, reward sensitivity and hedonic     responses, known to be related to dopamine function, have also been implicated in obesity and     obesity-related eating behavior. These reports have led to the concept that dopaminergic     abnormalities (e.g. reduced D2-like receptors) influence reward sensitivity, leading to     altered eating behaviors and eventually obesity. However, there are several critical     limitations of the human D2 receptor studies that limit the strength of their conclusions and     thus the interpretations and speculations embedded in literature that relies on this work.     First, estimates of D2-like receptors in humans have been confounded by potential differences     in endogenous dopamine release since the PET ligand (raclopride) used is known to be     displaceable from receptors by endogenous dopamine. Second, failure to rigorously screen     obese individuals for diabetes confounds conclusions, since diabetes has been independently     associated with dopaminergic abnormalities such as reduced D2-like receptors and muted     dopamine release in diabetic rats. Finally, no human studies have addressed whether reduced     D2-like receptor levels are a risk factor for obesity, a consequence of engaging in     obesity-related behaviors or being obese or all of the above.   "
247245|NCT01094769|"     The purpose of this study is to determine whether moxonidine is effective in reducing urine     albumin levels in patients with diabetic kidney disease.   "
247246|NCT01094782|"     The purpose of this study is to explore a new approach in assessing the effectiveness of     acupuncture therapy in the treatment chronic pain conditions.   "
247247|NCT01094795|"     The primary purpose of this study is to assess incidence rates of targeted infections,     malignancies and mortality among patients with rheumatoid arthritis who are treated with     abatacept.   "
247248|NCT01094808|"     This study is being done to evaluate the effects of pregabalin, a drug approved for     anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy     individuals.      The specific study hypotheses were as follows: 1) pregabalin increases sensation thresholds,     decreases sensation ratings, and increases compliance in response to balloon distension in     the colon; 2) pregabalin reduces colonic phasic and tonic motility in response to a     standardized meal; and 3) sensation ratings are lower with higher colonic compliance.   "
247249|NCT01094821|"     This is a pharmacodynamic study in healthy volunteers to determine the effects of a new 5-HT4     agonist on gastric, small bowel and colonic transit.   "
247250|NCT01094834|"     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and     pharmacodynamics of multiple administered DWP05195 in healthy volunteers   "
247251|NCT01094847|"     The purpose of this study is to compare and explore bioavailability of mosapride, the main     component of DWJ1252(Test drug) and mosapride medicine(Reference drug).   "
247252|NCT01094860|"     The goal of the clinical research study is to find the highest tolerable dose of nelarabine     when given as a continuous infusion to patients with a lymphoid malignancy that has not     responded to, or has come back after treatment with chemotherapy. The safety of this drug     will also be studied.   "
247253|NCT01094873|"     HCV002TV is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine     against Hepatitis C virus (HCV) in chronically infected patients. The vaccine is based on the     sequential delivery, by intramuscular route, of two different adenoviral vectors, of     chimpanzee and human origin respectively, bearing the same genetic information for HCV     antigens (NS region).      The two recombinant vaccine vectors, called AdCh3NSmut and Ad6NSmut, are weakened and unable     to multiply within the body; they are designed to induce an immune response against HCV     proteins. AdCh3NSmut and Ad6NSmut are being used in the ongoing HCV001 study in healthy     volunteers with very good safety and immunogenicity results.      HCV002TV is a dose-escalation study; the AdCh3NSmut is administered as priming vaccination     and Ad6NSmut as boosting vaccination.      The trial includes:        -  Arm A, in which vaccinated patients are into Interferon-ribavirin therapy (the gold          standard therapy for hepatitis C);        -  Arm B, in which vaccinated patients are not into therapy.   "
247254|NCT01094886|"     The study will describe the short-term effects the study drug, rivaroxaban, has on the body     when a patient is switched from enoxaparin injection (by needle) to oral rivaroxaban (by     mouth) for the prevention of blood clotting in the veins after elective total hip or total     knee replacement surgery. After providing written informed consent, screening procedures will     be completed to assess eligibility. After enrollment, all patients will be switched from     enoxaparin to rivaroxaban. Blood samples for the short-term effects of rivaroxaban will be     taken at various times while in the subacute unit. At the time of discharge, if the study     doctor feels it is appropriate, an adequate supply of rivaroxaban will be provided to     complete the full course of therapy. Upon completion of rivaroxaban therapy, all patients     will be required to have final study procedures performed. Safety evaluations at the final     visit will include clinical blood laboratory tests, a physical examination, urine pregnancy     test (if applicable), recording of any adverse events including details regarding any     bleeding episodes or blood clot events, and assessment of the surgical wound. All patients     will return any unused study medication and study participation will be complete.   "
247267|NCT01095055|"     This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63     AMA1, simian adenovirus encoding Plasmodium falciparum blood stage antigen, Apical Membrane     Antigen -1. All volunteers recruited will be healthy adults. They will be primed with various     doses of AdCh63 AMA1 administered intramuscularly. Some of the volunteers will receive a     booster vaccination with MVA AMA1 administered via intramuscular route. Safety data will be     collected for each of the eight regimens. Secondary aims of this study will be to assess the     immune responses generated by each of these regimes.   "
247268|NCT01095068|"     The aim of this study is to evaluate the improvement in skeletal muscle energetic capacity,     endothelial dysfunction and glycemic control induced by physical training in 20 sedentary     patients with a type 2 diabetes.The protocol consists in a physical training program with 3     sessions of 30 minutes per week during six consecutive weeks. A skeletal muscle biopsy, a     cardiac and humeral artery ultrasounds, a glycemic and tensional holters will be performed     before and at the end of the physical training program.   "
247255|NCT01094899|"     Assumptions and Objectives: The working hypotheses are: 1 - subjects with type 1 diabetes and     / or type 2, compared to subjects without diabetes are at risk for osteopenia and / or     abnormal bone structure the foot (calcaneus and ankle) can lead to bone deformities,     fractures and final stage of Charcot foot. These anomalies are favored by the presence of     peripheral neuropathy and plasma levels of advanced glycation end products higher than in     diabetic subjects without bone abnormalities.      The objectives of this research are to evaluate these anomalies quantitative and qualitative     bone in the foot (calcaneus and ankle) through the use of MicroScanner. In parallel a whole     body bone mineral density (BMD) and calcaneal ultrasound will be performed to measure bone     mineral density as realized in clinical practice in a defined population of patients with     type 1 or type 2. These bone abnormalities will be correlated with the presence of peripheral     neuropathy and the rate of advanced glycation end products of proteins and reference to     parameters of chronic inflammation and oxidative stress to better understand the     pathophysiology and target a population at risk.      The importance of this study is paramount in the management of diabetic foot. Indeed for the     moment we are dealing primarily the consequences of diabetes impact bone when bone     deformities have appeared with their attendant disability and the risk of recurrent     infections in areas of friction in this fragile environment. The ultimate goal is to target     people with diabetes have abnormal bone subclinical and take care to avoid changes to bone     deformities and find ways to treat them.   "
247256|NCT01094912|"     Number of patients in mobile palliative care units have pain of both nociceptive and     neuropathic origin. In certain cases, procedures of locoregional analgesia can be helpful.      The Purpose of this study is to evaluate the impact of techniques of locoregional analgesia     in a palliative population   "
247257|NCT01094925|"     Gabapentin has been very effective at treating pain after knee and hip operations,     hysterectomies, and many other types of operations. A previous study at the investigators'     hospital found that a single pre-operative dose of 600mg gabapentin produced a significant     reduction in pain after caesarean section. However, 19% complained of sedation. The purpose     of this study is to see whether a reduced dose of gabapentin will produce a similar     improvement in pain scores while avoiding adverse effects such as sedation or dizziness. The     objective of this study is to compare the efficacy of a single pre-operative oral dose of     gabapentin 300mg, versus 600mg and placebo in women undergoing Cesarean section. The     investigators' hypothesis is that gabapentin 300mg will result in decreased pain scores     similar to gabapentin 600mg, but with reduced side effects.   "
247258|NCT01094938|"     To compare CO values obtained by the lithium indicator dilution method and pulse power     analysis before, during and after anaesthesia and surgery for the elective repair of     abdominal aortic aneurysms. This will enable us to determine how often and when calibration     of the pulse power analysis derived CO is required.   "
247259|NCT01094951|"     This two-stage research study will        1. train caseworkers in three participating New York City Neighborhood Houses to screen          their clients for depression, and        2. examine the usefulness of training these caseworkers in an intervention that targets          barriers seniors face in receiving mental health services. In this intervention, called          ENGAGE, Case Workers will: 1. identify and address seniors' barriers to receiving mental          health services; 2. include the seniors' preferences in deciding which treatment options          to choose; and 3. help seniors connect with affordable mental health services of their          choice.   "
247260|NCT01094964|"     RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above     normal body temperature. Drugs used in chemotherapy, such as mitomycin C and epirubicin     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Biological therapies, such as bacillus     calmette-guerin (BCG) and interferon alfa, may stimulate the immune system in different ways     and stop tumor cells from growing. It is not yet known whether giving hyperthermia together     with mitomycin C is more effective than giving BCG or standard therapy as second-line therapy     in treating patients with recurrent bladder cancer.      PURPOSE: This randomized phase III trial is studying how well hyperthermia given together     with mitomycin C works compared with BCG or standard therapy as second-line therapy in     treating patients with recurrent bladder cancer.   "
247261|NCT01094977|"     The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces     perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis     surgery.   "
247262|NCT01094990|"     Null hypothesis The proportions of vomiting are not different between dexamethasone and     placebo in the patient after sedation with intravenous ketamine and lumbar puncture with     intrathecal chemotherapy Alternative hypothesis The proportions of vomiting are different     between dexamethasone and placebo in the patient after sedation with intravenous ketamine and     lumbar puncture with intrathecal chemotherapy   "
247263|NCT01095003|"     The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line     metastatic settings, led to a raise of patients presenting with metastatic breast cancer     after treatment with these agents. Options for the treatment of patients who have progressed     after an anthracycline and a taxane are limited. The high level of in-vitro synergy of     vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the     encouraging response rate observed while combining IV vinflunine to oral capecitabine make it     a promising combination to investigate further in a phase III trial. This phase III trial     will evaluate the effectiveness and the safety profile of such combination for the treatment     of patient with advanced breast cancer previously treated with or resistant to anthracycline     and taxane resistant.   "
247264|NCT01095016|"     This is an open-label, randomized, cross-over, active-controlled study to evaluate the     efficacy and safety effects using Meptin® Swinghaler and Berotec N® Metered Aerosol in stable     asthma patients   "
247265|NCT01095029|"     The purpose of this study is to determine whether Sacral Nerve Stimulation (SNS) for     idiopathic faecal incontinence affect cortical and deep brain activity in an acute and     chronically stimulation model. Furthermore the association between brain activity and     unilateral/bilateral SNS will be studied in each patient. Brain activity will be studied by     use of positron emission tomography.   "
247266|NCT01095042|"     The study aims at showing that the susceptibility in the stress is more raised at the person     affected digestive pathologies (SII or IBD) in forgiveness than healthy subjects.   "
247271|NCT01095107|"     Nutritional insufficiency is defined as an inadequate amount of nutrition due to decreased     food/caloric intake, often due to an eating disorder, such as anorexia nervosa or bulimia.     Often when re-feeding these chronically malnourished patients, they can experience changes in     their mood and/or body image, metabolic abnormalities and functional aberrations of their     gastrointestinal system described as re-feeding syndrome, which all can adversely effect     their recovery. In our pilot study, we are attempting to determine whether adjustments in the     amounts of energy dense foods, such as fat, in the current inpatient protocol meal plans will     lead to a change in the hospital stay duration, alter their recovery by affecting vital     signs, weight or need for supplemental feeds or medications, effect gastrointestinal     re-feeding syndrome symptoms (bloating, gastroesophageal reflux, constipation, diarrhea,     abdominal pain), and/or effect their perceived body image or cause any changes in their mood.        1. To determine whether a higher amount of fat calories per day within a normal range in a          Nutritional Insufficiency patient's diet will lead to a shorter inpatient hospital stay          duration.        2. To determine whether a higher amount of fat calories per day within a normal range in a          Nutritional Insufficiency patient's diet will lead to less gastrointestinal re-feeding          syndrome symptoms.        3. To determine whether a higher amount of fat calories per day within a normal range in a          Nutritional Insufficiency patient's diet will effect their body image and/or alter their          mood.   "
247272|NCT01095120|"     Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is     being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line     therapy to patients with advanced gastric cancer.   "
247273|NCT01095133|"     The purpose of this research study is to learn about whether treating the esophagus with     amiloride reduces either the frequency or the time to onset of acid-induced heartburn in     patients with nonerosive reflux disease. In particular, we are looking at people who have     either had complete relief while using a Proton Pump Inhibitor (PPI) or who have only had     some relief of symptoms while on a PPI.   "
247274|NCT01095146|"     Macrophage activation syndrome(MAS) is a complication of bone marrow suppression,     coagulopathy and CNS dysfunction which occurs in rheumatic diseases. Normally the     (Hemophagocytic Lympho-Histiocytosis) HLH-2004 criteria is used to diagnose patients with     MAS. However this criteria is probably not sensitive and would probably be fulfilled quite     late into the disease. Thus there would be an unacceptable delay. Ravelli et al came up with     a different set of criteria based on data of patients reported in literature.      Systemic onset juvenile idiopathic arthritis (SoJIA) is the most common cause of MAS. MAS in     other rheumatic illnesses occurs in the setting on unbridled inflammation. In both SoJIA and     uncontrolled rheumatic disease the patient is liable to have high WBC counts and high     platelet counts. Bone marrow suppression which is one of the pathognomic features of MAS     would be picked up very late if absolute cut off values were utilized. Kelly et al used the     same arguments in their review to suggest that in MAS/Reactive hemophagocytic     lymphohistiocytosis(ReHLH), the trend of change in laboratory parameters would be more useful     than absolute cut offs. Hence the investigators propose new candidate criteria which are     based on trends of laboratory parameters and seek to determine their utility in comparison to     absolute cut offs of HLH or Ravelli criteria. The investigators also wanted to determine that     among the Ravelli criteria and HLH-2004 criteria, which were fulfilled earlier in patients     diagnosed as having MAS.      Study hypothesis:-Criteria which measure serial trend of laboratory parameters would be     fulfilled earlier than absolute cut offs when diagnosing MAS in patients with rheumatic     illness.   "
247275|NCT01095159|"     This is a prospective, comparative randomized controled trial. The general purposes of this     study is to compare the efficacy and safety of TVTO™ and TVTSecur™ as surgical treatment for     female urinary stress incontinence.   "
247276|NCT01095172|"     Hypothesis:        -  That B cell depletion, rather than reducing acute rejection, will allow minimisation of          immunosuppression, which may lead to better graft survival.      Aim:        -  To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression          regime allows a reduction in steroid administration.      Objectives:        -  To assess whether B cell depletion affects graft function, acute rejection and          complication rates        -  To assess whether the T cell response to allotransplantation is impaired by B cell          depletion.   "
247277|NCT01095185|"     This is a prospective, double blind controlled trial in which patients with esophagic     variceal bleeding treated with standard therapy (endoscopic variceal ligation(EVL) +     B-blockers), will be randomized to receive statins or placebo. They will be followed up     during 12 months to determinate whether statins are effective in prevention of variceal     bleeding recurrence and evaluate patient survival.      Randomization will be stratified according to the degree of hepatic insufficiency, assessed     by the Child-Pugh classifications (A,B or C).   "
247278|NCT01095198|"     Up to 30% of Canadian women do not participate in Pap smear screening for cervical cancer     prevention despite many being members of family practices and having access to family     physicians. One reason is reluctance to undergo pelvic examination.      The investigators purpose is to determine whether the offer of vaginal self sample collection     for oncogenic human papillomavirus (HPV) testing increases participation in cervical cancer     screening compared to repeat reminder for Pap smear testing among female family practice     members who have not previously responded to invitations for Pap testing.   "
247279|NCT01095211|"     Observations studies documented a correlation between plasma concentrations of homocysteine     and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as     effective homocysteine lowering treatment) can improve cognitive function in elderly people.   "
247286|NCT01095302|"     Primary Objective:        -  To determine the maximum tolerated dose based on the incidence of dose limiting toxicity          and the maximum administered dose of ombrabulin in combination with docetaxel and          cisplatin administered every 3 weeks in patients with advanced solid tumors      Secondary Objectives:        -  To assess the overall safety profile of the combination therapy        -  To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR          258063, docetaxel and cisplatin in combination.        -  To evaluate anti-tumor activity of the combination therapy   "
247708|NCT01091922|"     The primary propose of this study is to determine the impact of flavanol-rich cocoa on the     growth of the human gut microbiota.   "
247287|NCT01095315|"     Maternal hypotension is a common problem during cesarian section under spinal anesthesia. The     possible explanation for this is combined aortocaval compression by gravid uterus in     parturient in addition to reduced systemic vascular resistance by spinal anesthesia. The     investigators evaluated if the incidence of hypotension would be decreased by delayed supine     positioning, by maintaining lateral position for 6 min after spinal injection, in patients     undergoing elective cesarean section.   "
247288|NCT01095328|"     Q fever in the Netherlands is becoming more common. A Q fever infection is a serious threat     to certain risk groups,including pregnant women. Pregnant women are more often than the     general population asymptomatic. Studies from France show that an infection with Coxiella     burnetii may cause obstetric complications including spontaneous abortion, intrauterine fetal     death, intrauterine growth retardation and oligohydramnios.      The aim of this study is to assess the effectiveness and cost effectiveness of a     multidisciplinary screening program, whereby pregnant women in first line healthcare in     high-risk areas for Q fever are screened with a single blood sample during pregnancy. If     found positive for Q fever, advise for antibiotic treatment will follow as part of regular     healthcare. Treatment is therefore not part of the study protocol.      The results of this study will give more insights in the risks of asymptomatic Q fever in     pregnancy and the benefits and harms of a screening strategy during pregnancy. This study     will be used to give an evidence based advice to the Dutch minister of health on screening     for Q fever in pregnancy.   "
247289|NCT01095341|"     The purpose of this study is to evaluate the frequency and the clinical course of     postoperative hyperthyroidism following surgery of tertiary hyperparathyroidism (THP) and to     determine the diagnostic value of thyroglobulin in this setting.   "
247290|NCT01095354|"     The primary objective of this study is to determine if well-controlled asthmatic patients     followed in subspecialty asthma clinics between the ages of 3 - 18 years can be distinguished     from healthy controls using lung clearance index, a parameter from the multiple breath     washout test. Also, to correlate lung clearance index with asthma sputum cell counts.   "
247291|NCT01095367|"     The purpose of this research is to determine if a film to prevent adhesions will improve the     area of distribution of a contrast dye (representative of chemotherapy) in the abdominal     cavity (belly) of women who have undergone surgery for ovarian cancer as compared with     patients who have not had adhesion barrier sheets placed in the belly. It is believed that     this film, Seprafilm™, reduces adhesions (scar tissue between tissues and organs) in the     abdominal cavity following surgery. Adhesions can limit the distribution of the chemotherapy     agent placed in the abdomen to treat the ovarian cancer. Thirty subjects will receive     adhesion barrier sheets and thirty will not. To determine if the sheets prevent adhesions,     all subjects will have a dye inserted into the abdomen and then have X-rays of the abdomen to     look at the distribution of the dye between the two groups.      Hypothesis:      Null hypothesis: There is no difference in area of distribution of the intraperitoneal dye in     the Seprafilm ™ vs. no Seprafilm™ groups.      Alternative hypothesis: Seprafilm™ reduces adhesion formation and there is a larger area of     distribution of intraperitoneal dye in the Seprafilm™ group.   "
247292|NCT01095380|"     Background: Body weight supported (BWS) locomotor training improves overground walking     ability in individuals with motor-incomplete spinal cord injury (SCI). While there are     various approaches available for locomotor training, there is no consensus regarding which of     these is optimal. The purpose of this ongoing investigation is to compare outcomes associated     with these different training approaches.      Subjects and Methods: Subjects with chronic motor-incomplete SCI have completed training and     initial and final testing. Subjects were randomly assigned to 1 of 4 different BWS     assisted-stepping groups, including: 1) treadmill training with manual assistance (TM), 2)     treadmill training with stimulation (TS), 3) overground training with stimulation (OG), or 4)     treadmill training with robotic assistance (LR). Prior to and following participation the     investigators assessed:        -  Walking-related outcome measures: overground walking speed, training speed, step length          and step symmetry.        -  Spinal cord reflex activity        -  Electromyographic (EMG) associated with walking      Hypotheses:      In individuals with incomplete spinal cord injury (SCI):        1. A 12-week period of body weight supported treadmill training with TS will produce          improvements in walking function that are significantly greater than those produced by          training with TM, OG, LR.        2. TS training will be associated with greater changes to spinal reflex activity than will          be observed in subjects trained with manual assistance or non-assisted stepping. Changes          to spinal reflex activation will be such that this activity more closely resembles that          observed in non-disabled (ND) individuals.        3. Following participation in this walking regimen, EMG activity observed during walking in          all groups will be more robust, more consistent and better coordinated than EMG measures          obtained prior to training.   "
247293|NCT01095393|"     Observational registry to assess the longer-term risk of serious infections and malignancies     reported with TNFα-blocker therapy, as well as the longer-term risk of cardiovascular and     thromboembolic events in adult Rheumatoid Arthritis (RA) patients treated with Cimzia® as     compared to non-biologic DMARD-treated controls.   "
247294|NCT01095406|"     The present protocol will demonstrate the safety, feasibility and efficacy of a newly     computerized protocol integrated into a ventilator: S1 ventilator (Hamilton Medical). During     ventilation with S1 ventilator, the respiratory support including oxygenation and CO2 removal     parameters are continuously adapted to patient respiratory status using science based rules.     The present protocol is designed as a pilot evaluative study where the researchers will     evaluate the safety, feasibility and efficacy of ventilating children during the weaning     phase with the S1 ventilator for 5 hours, and compare to conventional ventilation.   "
247295|NCT01095419|"     The purpose of this study is to evaluate the effects of Massage Therapy for improving the     quality of sleep in patients on postoperative period of coronary artery bypass graft surgery     (CABG).   "
247296|NCT01095432|"     The purpose of this study is to study samples of rectal mucosa (the moist lining of the     rectum) using a new light scattering technology, called partial wave spectroscopy (PWS) in     patients who will undergo a standard of care colonoscopy or a flexible sigmoidoscopy and have     a history of ulcerative colitis (UC).   "
247297|NCT01095445|"     The purpose of this study is to evaluate the effect of 48 vs 24 weeks of treatment with     Peginterferon alfa-2b plus weight-based ribavirin on Sustained Virologic Response (SVR) and     relapse rates in patients infected with genotype 3 chronic hepatitis C (CHC) who do not     achieve a Rapid Virologic Response (RVR) but attain a complete Early Virologic Response     (cEVR).   "
247651|NCT01100645|"     The main objective of this study is to evaluate the clinical efficacy of the drug Sominex     (Valeriana officinalis L., 40 mg, 30 mg Crataegus oxyacantha L. and Passiflora incarnata L.     50 mg) manufactured by the Laboratory EMS S / A, compared to placebo in improving sleep     efficiency, based on the response of the sleep quality questionnaire (MSQ) and     polysomnographic parameters described below:        -  Latency to onset of sleep;        -  Total time of sleep;        -  Rapid eye movement (REM) sleep latency;        -  Duration of REM sleep   "
247298|NCT01095458|"     Weight loss and maintenance continues to be problematic for individuals who are overweight or     obese. State-of-the-art treatment generally involves a behavioral weight loss clinic that     emphasizes nutrition, physical activity, and lifestyle changes and is delivered face-to-face     between health educators and small groups of participants. This delivery system is time     consuming, expensive, and presents numerous barriers to the participant. We have developed a     phone based delivery system that eliminates many of these barriers by substituting group     conference calls for clinics and by delivering weight loss materials and products directly to     the participant.      Hypothesis 1: We expect equivalent weight loss from baseline for phone and clinic groups and     have defined equivalence as no greater than 4 kg difference between groups based on our pilot     data and potential for clinical significance.      Hypothesis 2: During weight maintenance it is likely that participants will experience some     weight re-gain. We expect both phone and clinic groups to re-gain a similar amount of weight     and that weight for both groups at 18 months will be significantly less than baseline     weights.      Hypothesis 3: We will complete a cost analysis to determine which delivery method is more     economical. Specifically, we expect the phone delivery system to be more cost effective than     that of the in-person clinics.   "
247299|NCT01095471|"     This is a follow-on, multi-centre, open-label, clinical trial. The purpose of this trial is     to investigate the concentrations of serotype-specific antibodies to IgG included in PCV13 in     children who have received either the PCV7 or PCV13 primary immunisation at 2, 4 and 12     months of age. We intend to recruit all interested participants who completed the     Wyeth-sponsored PCV13 infant trial study (6096A1-007) at selected study sites (i.e. those     that recruited the majority of the children in the original study). The study will start in     March 2010, at which time the eldest participants in the 6096A1-007 study will be     approximately 42 months of age. There will be two visits per participant, 1 month apart from     each other. At visit one, all participants will have a blood test and receive a dose of     PCV13. At visit 2, all participants will have a blood test and will be offered the remaining     pre-school booster vaccinations unless they have already received them.   "
247300|NCT01095484|"     The named patient program will allow investigators to supply rotigotine transdermal system to     patients who have a documented medical necessity to receive treatment with the drug.   "
247301|NCT01095497|"     The objectives of the study are to:        1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection          in subjects with hereditary angioedema        2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by          subcutaneous injection        3. Assess the immunogenicity of CINRYZE following subcutaneous administration   "
247302|NCT01095510|"     The objectives of this study were to evaluate: (1) the dose response and (2) the     pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE     for the treatment of acute angioedema attacks in children above and below 25 kg and less than     12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and     tolerability following IV administration of CINRYZE in this study population.   "
247303|NCT01095523|"     Background:        -  Survival rates for colorectal cancer depend on a number of factors, including the          existence of tumors outside the colon and rectum. Patients who had tumors elsewhere in          the abdomen (such as in the peritoneum or ovaries) when they were diagnosed, as well as          patients who had bleeding or obstruction when they were diagnosed, have a high risk of          cancer recurrence even after surgery or other treatment.        -  If additional tumors are discovered early and removed while they are still small (often          before they can show up on scans), survival rates may improve. In addition, patients who          receive a heated chemotherapy solution delivered directly to the abdomen often have          better treatment outcomes regardless of whether additional tumors were found. Further          research can help determine the usefulness of both of these treatments in improving the          outcomes of patients with colorectal cancer.      Objectives:      - To determine whether patients who have had surgery for colorectal cancer have improved     outcomes after receiving additional surgery combined with direct chemotherapy, compared with     those who receive the current standard of care.      Eligibility:      - Individuals at least 18 years of age who have had surgery for colorectal cancer within the     past 14 months, who are considered to be at high risk for cancer recurrence, and whose     current imaging scans show no signs of additional tumors.      Design:        -  Participants will be divided into two treatment groups: a surgery group and a standard          of care group.        -  Participants who had surgery less than 11 months ago will be enrolled in a 3-month          lead-in phase to receive standard follow-up care, including labs, scans, and physical          examinations, before being randomized to a treatment group between 11 and 14 months          after surgery. Participants who had surgery between 11 and 14 months ago will be          randomized at the time of enrollment.        -  Participants in the surgery group will have the following procedures within 2 weeks of          randomization:        -  Abdominal surgery where surgeons will look for and remove any tumors and take biopsies          to check for cancer cells        -  Heated chemotherapy, with three chemotherapy drugs administered directly to the abdomen        -  In-patient recovery and follow-up visits beginning 3 to 6 weeks after discharge.        -  Participants in the standard of care group will have the standard follow-up schedule for          high-risk colorectal cancer patients:        -  Clinic evaluations every 3 months for 2 years, and then every 6 months for 3 years and          yearly thereafter....   "
247304|NCT01095536|"     Risk factors for postoperative shoulder pain after laparoscopic cholecystectomy were not     clear. Moreover, risk factors for postoperative emesis specially for this surgery were not     detailed and accurate. The present study is a prospective cohort study to identify risk     factors for shoulder pain and emesis within 24 hours in Chinese patients after laparoscopic     cholecystectomy under general anesthesia.   "
247305|NCT01095549|"     The prevalence of peripheral artery disease (PAD) defined as ankle-brachial index (ABI) less     than 0.9 was about 15~30% in patients with end stage renal disease (ESRD), which was higher     than those with normal renal function. A lower ABI and a higher brachial-ankle pulse wave     velocity (baPWV) are good markers to predict the risk of PAD and atherosclerosis     respectively. In addition, baPWV>2,100 cm/s was shown to be related to potential PAD. ABI     <0.9 was positively associated with vascular access failure in hemodialysis (HD) patients and     our previous study has demonstrated that far infrared (FIR) therapy can improve access flow     and unassisted patency of atrioventricular (AV) fistula.      The aims of this study are to evaluate (1) the frequency of and (2) risk factors associated     with abnormal ABI and PWV as well as (3) the effect of FIR on ABI and PWV and markers related     to endothelial dysfunction in HD patients.   "
247306|NCT01095562|"     This is an efficacy and safety study evaluating an experimental treatment for cognitive     deficits in adults with schizophrenia.   "
247320|NCT01095744|"     The first objective is to asses influence of age on amyloid load measured by PET imaging     using Pittsburgh B compound (PiB) radio-tracer, in Alzheimer's disease(AD). This will allow     the determination of brains age-specific deterioration factors by comparing Early onset AD     (EOAD), Late onset AD (LOAD)and atypical focal cortical AD (PCA and LPA). The amount of brain     lesions in AD patients is estimated by:        1. measuring the rate of cortical brain atrophy,        2. FDG imaging of glucose metabolism reflecting neuronal activity, and        3. for patients who benefited from a lumbar puncture; Cortical-spinal fluid (CSF) amounts          of amyloïd and tau proteins are measured.   "
247307|NCT01095575|"     Background and Objectives: Neuraxial administration of morphine is an effective way of     controlling postoperative pain and reducing analgesic consumption. Several animal models have     demonstrated that preemptive administration of neuraxial narcotics reduced pain while others     revealed the induction of post-incisional hypersensitivity. There have been no consistent     results in clinical setting either. This double blind, randomized study compared the effects     of PRE- vs. POST-incisional administration of neuraxial morphine on postoperative pain     perception and analgesic requirements over 48 hours following laparotomy for open colectomy     under standardized general anesthesia.      Methods: Twenty patients received epidural morphine (3 mg) pre-incision and saline after     wound closure (MO1 group), and 20 patients received epidural saline before incision and     morphine after wound closure (MO2 group). Postoperatively, all patients received boluses of     morphine (1.5 mg) via intravenous patient-controlled analgesia (IV-PCA), and rescue doses of     intramuscular diclofenac (75 mg) every 6 hours, as needed.   "
247308|NCT01095588|"     This study is designed to look into the effect of avanafil on blood levels of warfarin and to     investigate its effect on prothrombin time/international normalized ratio (INR) in healthy     men.   "
247309|NCT01095601|"     This study will assess the effect of food on the pharmacokinetics of avanafil (Formulation     II); determine the relative bioavailability of two avanafil tablet formulations (Formulation     I versus Formulation II) and will investigate the dose-proportionality of Formulation II     avanafil tablet.   "
247310|NCT01095614|"     Women sexual hormones (i.e. estrogen) are involved in the regulation of substrate utilization     and storage. Being under oral contraception (OC) may conduct to metabolic and hormonal     modifications, but results are confused regarding the impact on substrate utilization. In the     present study, the aim is then to explore the effect of hormonal status on substrate     utilization during sous-maximal exercise, comparing women with and without OC.      We hypothesised that women under OC have a lower Respiratory Exchange Ratio (RER) at exercise     than women without contraception underlying a greater reliance on fat oxidation.   "
247311|NCT01095627|"     This study is aiming at evaluating whether the number and size of exhaled particles changes     during the increase and decrease of bronchial constriction in subjects with mild intermittent     asthma.   "
247312|NCT01095640|"     Marketed by Galderma Laboratories, L.P., Differin® (adapalene 0.3% topical gel) is a safe and     effective topical therapy used for the treatment of acne vulgaris. Actavis Mid-Atlantic LLC     has developed a generic formulation of adapalene 0.3% topical gel and the current study is     designed to evaluate the safety and efficacy of this formulation.   "
247313|NCT01095653|"     The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can     improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never     been treated with medication or have been on medication for less than 24 weeks since their     original diagnosis of Diabetes. The safety of this treatment will also be studied.   "
247314|NCT01095666|"     The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can     help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well     controlled on metformin alone. The safety of this treatment will also be studied.   "
247315|NCT01095679|"     Periodic ventilation that includes CHEYNE Stokes ventilation is a pathological pattern     characterized by alternating periods of hyperpneas and apnea-hypopneas. It occurs generally     during sleep, at high altitude and in hypoxic conditions in healthy subjects, and in some     diseases like congestive heart failure. One study conducted on an animal model suggested that     baclofen, a drug already used against spasticity in humans, could also be effective against     periodic ventilation. The goal of the study is therefore to assess this hypothesis on     hypoxia-induced periodic ventilation in healthy subjects during sleep.   "
247316|NCT01095692|"     Nowadays the clinical significance of an occult stress urinary incontinence and its optimal     treatment is not known.Regarding treatment, there are 2 main approaches : either the     systematic preventive treatment of the occult stress urinary incontinence by means of a     tension free vaginal tape (TOT) together with the treatment of prolapse or the treatment of     prolapse in the first place and treatment of stress incontinence in a second time when and if     it appears.This study is expected to provide objective evidence concerning the efficacy and     security of TOT implantation for the prevention treatment of occult stress urinary     incontinence in women with pelvic organ prolapse and occult urinary incontinence.The     perspective is to improve the management of these patients by providing evidence based     recommendation for their treatment.   "
247317|NCT01095705|"     The purpose of this study is to determine the additive value of hypnosis to improve patient     comfort during transesophageal echocardiography (TEE).   "
247318|NCT01095718|"     This study is a comparison of 3 learning techniques, Errorless learning, modelling and trial     and error, in the relearning of IADL of Alzheimer patients from mild to moderately severe     dementia.      Tailored IADL will be chosen for each patient (n=300) and trained in individualized sessions     for 6 weeks.      This study focuses on the relationship between learning techniques, IADL and memory     processes, in a threefold way:        1. it will determine which of the of the three learning techniques (EL, MR, TE) will          improve most the (re)learning of instrumental skills in different dementia stages using          a randomized controlled trial;        2. it will explain the role of implicit and explicit memory mechanisms in the (re)learning          of IADL tasks; and        3. as a secondary objective, it will explore the possible drug treatment by behavioral          intervention interaction effects of the three learning techniques.   "
247319|NCT01095731|"     The purpose of this phase II study is to further assess the safety of tiopronin in aneurysmal     subarachnoid hemorrhage(aSAH) patients in order to obtain preliminary data on the efficacy of     tiopronin versus placebo in reducing serum and cerebrospinal fluid (CSF) 3AP levels in this     patient population.      Funding Source - FDA Office of Orphan Products Development   "
247352|NCT01081964|"     A double-blind, three-arm study, to evaluate the safety and efficacy of two dosing regimens     of zabofloxacin (a fluoroquinolone antibiotic) in community acquired pneumonia.   "
247477|NCT01096355|"     This phase I trial is studying the side effects, best way to give, and best dose of     gamma-secretase inhibitor RO4929097 in treating patients with metastatic or unresectable     solid malignancies. Enzyme inhibitors, such as gamma-secretase inhibitor RO4929097, may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
247321|NCT01095757|"     The purpose of this study is to test whether the addition of the drug plerixafor to treatment     with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the     chances of transplant. The study will look for the activation of a certain type of blood     cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The     investigators will follow the number of patients that achieve the target numbers of CD34+     cells. The number of patients achieving the target level of CD34+ cells, and the total number     of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy     and G-CSF, without plerixafor.      The investigators will also test the safety of the combination of plerixafor with     chemotherapy and G-CSF and look at the success of the transplantation after 12 months.   "
247322|NCT01095770|"     The purpose of this study is 3 fold:-        1. To compare the efficacy and complication rates of 2 widely used methods, conventional          irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of          AF ablation for PAF.        2. To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared          to the 'gold standard' DDD pacemaker Holter.        3. To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF          ablation therapy for PAF.   "
247323|NCT01095783|"     The purpose of this study is to determine whether a physiotherapeutic intervention is     effective in the treatment of low back pain in hemodialysis patients   "
247324|NCT01095796|"     To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing     fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir     disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected,     antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who     are not candidates for non-nucleoside reverse transcriptor-based STRs.   "
247325|NCT01095809|"     The purpose of this study is to determine whether intravitreous bevacizumab or intravitreous     triamcinolone acetonide are effective and safe in the treatment of uveitic macular oedema   "
247326|NCT01095822|"     People with both hypertension and diabetes have a higher chance of developing heart and     arterial problems that could be reduced with anti-coagulant therapy. Valsartan (Diovan), an     FDA approved angiotensin-II receptor antagonist (blocker) clinically indicated for the     treatment of essential hypertension is known to inhibit platelet activity in both an in vitro     and ex vivo setting. Aliskiren (Tekturna) is a recently FDA-approved potent direct renin     inhibitor which is also an effective anti-hypertensive agent in patients with     mild-to-moderate hypertension and which, in vitro, modulates antithrombin III in plasma.     Therefore, in addition to being clinically approved anti-hypertensive medications, combining     these two agents will potentially target both primary hemostasis (platelets) and     anticoagulant (antithrombin-III is a cornerstone substrate for heparin) properties to exert     their anti-thrombotic efficacy simultaneously. This combination strategy may not only improve     hypertension management, but also improve vascular outcomes in high-risk diabetic population     via favorable effects on anti-thrombotic activity. Importantly, there have been no     significant additional safety concerns of using the combination of aliskiren and valsartan.     The investigators hypothesis is that valsartan 160 mg/daily in combination with aliskiren     150-300 mg/daily for 4 weeks will favorably affect blood levels of     platelet/coagulation/fibrinolytic biomarkers (ie, diminish platelet activity, and enhance     antithrombin III potency) when compared with monotherapy with aliskiren 150mg/daily in     hypertensive patients with type 2 diabetes mellitus.   "
247327|NCT01095835|"     This study will compare the efficacy and safety of 2 different durations of treatment with     pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen     (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a     treatment alone and in combination with lamivudine (LAM). The anticipated time on study     treatment is 1-2 years, and the target sample size is 100-500 individuals.   "
247328|NCT01095848|"     To determine the safety and immunogenicity profile of two (2) different doses of the vaccine     DPX-0907 to treat breast, ovarian and prostate cancer.   "
247329|NCT01095861|"     Patients presenting for elective surgery requiring tracheal intubation will be randomized to     one of two different endotracheal tubes (ETT).   "
247330|NCT01095874|"     The purpose of this study is to compare outcome of high risk myelodysplasia patients aged     from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk     myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever     thrombocytopenia. Patients are registered when they acquire risk factors.   "
247331|NCT01095887|"     The purpose of this study is to try to determine if the drug eculizumab can help prevent     antibody-mediated rejection in patients undergoing a kidney transplant from a living donor     with a different blood type than their own.   "
247332|NCT01095900|"     Intra-sphincteric injection of botulinum toxin seems to be a reliable option causing     temporary alleviation of sphincter spasm and allowing the fissure to heal. study is to     compare the outcome of surgical sphincterotomy and botulinum toxin injection treatments in     patients with uncomplicated chronic anal fissure.   "
247333|NCT01095913|"     The goal of this clinical research study is to find lymph nodes before surgery using a dye     called indocyanine green (IC-Green).      Objectives:        1. To determine the feasibility of using nonradioactive optical imaging techniques with          indocyanine green (ICG) as a fluorescent contrast agent to identify all axillary lymph          nodes.        2. To determine the feasibility of using nonradioactive optical imaging techniques with ICG          as a fluorescent contrast agent to characterize lymphatic architecture and function in          women with breast cancer who are scheduled for axillary node dissection.   "
247334|NCT01095926|"     Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the     predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity     .   "
247335|NCT01095939|"     The purpose of the Post-preeclampsia Renal Project is to investigate the renal function of     preeclamptic women after delivery, and to determine whether the anti-hypertensive drug named     benazepril efficiently improves the dysfunctions observed.   "
247422|NCT01088191|"     The purpose of this study is to evaluate safety and preliminary efficacy of MSB-CAR001 in     subjects who have recently undergone an Anterior Cruciate Ligament Reconstruction   "
247336|NCT01095952|"     The aim of this multi-center research study is to evaluate the performance (primary purpose)     and safety of a new algorithm aimed at controlling ventricular rate (VR) during rapidly     conducted atrial fibrillation (AF) by delivering AV node stimulation (AVNS) from the atrial     lead placed at a septal position, and designed with the purpose of reducing inappropriate     shocks. Additional purposes include the assessment of a possible application of AVNS aimed at     allowing prolonged control of VR during AF and reducing AF symptoms, and evaluation of     implantation data on selective placement of the atrial lead in postero-septal right atrium.     About 37 patients will be followed for half a year.   "
247337|NCT01095965|"     The purpose of this study is to implement a nutrition education programme that was developed     for type 2 diabetic adults in a resource poor setting and to evaluate the programme's     effectiveness on health outcomes      A randomized controlled clinical trial study design will be used. One group (experimental     group) will receive the nutrition education while the other group (control group) will     receive the usual care.      Setting: Two Community health centres in Moretele Health Sub-District, North West Province,     South, Africa      Effectiveness of the nutrition education will be evaluated for the following outcomes:        -  clinical             -  blood sugar control based on HbA1c levels (primary outcome)             -  lipid profile (total cholesterol, low density cholesterol, high density cholesterol               and triglycerides)             -  blood pressure             -  body mass index        -  dietary intake        -  others -diabetes knowledge, attitudes towards diabetes      Outcome measurements- at six and 12 months, this will be compared with the baseline data.      Hypotheses:        -  the experimental group will have a significantly lower HbA1c compared to the control          group        -  the experimental group will have significantly better outcomes for dietary intake, blood          lipid profile, blood pressure, body mass index, diabetes knowledge and attitudes towards          diabetes and its treatment.   "
247338|NCT01095978|"     To describe the relief of symptoms, tolerability, and compliance of treatment with Klacid®     sustained release (SR) at a dose of 1000 mg once daily in patients with acute tracheitis,     acute tracheobronchitis, acute bronchitis, or in patients with acute exacerbation of chronic     bronchitis or mild community-acquired pneumonia.      This postmarketing observational study is non-interventional and is being conducted in a     prospective, single-arm, single-country, multicenter format.      Klacid SR will be prescribed in usual manner in accordance with the terms of the local market     authorization with regards to dose, population, and indication as well as with local     guidelines.   "
247339|NCT01095991|"     The purpose of this study is to evaluate the effects of AZD1656 on Sitagliptin     pharmacokinetics and vice versa in patients with Type 2 Diabetes Mellitus.   "
247340|NCT01096004|"     The primary purpose of this study is to investigate different methods to evaluate the effect     of AZD4017 in adipose tissue after single and multiple doses of AZD4017 in abdominally obese     but otherwise healthy subjects.   "
247341|NCT01096017|"     This is a single blind, single dose, crossover study to investigate the relative efficacy of     terbutaline Turbuhaler® 0.4 mg in relation to salbutamol pressurized Metered Dose Inhaler     (pMDI) 200 μg in Japanese adult asthmatic patients.The secondary objective of this study is     to investigate safety of terbutaline Turbuhaler® 0.4 mg in Japanese adult asthma patients by     means of adverse events (AEs) and vital signs (blood pressure, pulse rate). The subject     population includes Japanese patients (16 years of age or older) with asthma who need     treatment with inhaled Glucocorticosteroids (ICS).   "
247342|NCT01096030|"     This will be an uncontrolled, open-label, non-randomized, phase I study. The primary     objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety     and tolerability of Regorafenib administered orally as a single agent in Chinese patients     with advanced solid tumors. The secondary objectives are to evaluate tumor response of     patients treated with Regorafenib.   "
247343|NCT01096043|"     Study CXL-1020-02 employs is designed to further define suitable clinical dosages for     CXL-1020 which will be utilized in a later Phase IIb study. The study is conducted in 3     different stages called 'strata and evaluates the potential utility of this drug for the     treatment of patents who are hospitalized with heart failure.   "
247344|NCT01096056|"     The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline     Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age.      This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. The     impacted sections are study design, outcome measures, intervention sections and number of     subjects.   "
247345|NCT01081873|"     Document treatment patterns and evaluate LUCRIN / LUCRIN-TRIDEPOT® (Leuprolide) and     alternative therapeutic approaches to the treatment of advanced prostate cancer during normal     clinical practice and in accordance with the terms of the Belgian marketing authorization and     reimbursement conditions.   "
247346|NCT01081886|"     The objective of this clinical study is to evaluate the operative performance of the PEAK     PlasmaBlade 4.0 during total knee replacement; to monitor and record post-operative pain,     activity level, narcotic consumption, adverse events, and skin scarring following surgery;     and compare these outcomes to the current standard of care (SOC).   "
247347|NCT01081899|"     The purpose of this study is to evaluate the effectiveness of the LCP-I Program in improving     the quality of end-of-life care provided to cancer patients who die on hospital medical wards     as compared to standard healthcare practices.   "
247348|NCT01081912|"     The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate     controlled-release capsules in subjects with chronic low back pain.   "
247349|NCT01081925|"     The purpose of the study is to recognize main causes of acute decompensation of chronic     congestive heart failure.   "
247350|NCT01081938|"     Primary Objective:      1- Proportion of patients with mean daily glycemia <140mg/dL during the period of 7 days of     treatment with glargine plus supplemental glulisine versus patients with glulisine sliding     scale.      Secondary Objective:        1. Incidence of moderate hyperglycemia (>140mg/dL) during the treatment period.        2. Incidence of hypoglycemia (<60mg/dL and < 40mg/dL) during the treatment period.        3. Incidence of severe hyperglycemia (>400mg/dL) during the treatment period.        4. Total dose of insulin and correction dose in each group.   "
247351|NCT01081951|"     To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4)     when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian     cancer.   "
247353|NCT01081977|"     In developing countries up to 50% of children become anemic by 12 months of age(1. Iron     deficiency anemia is a major risk factor for neonatal and infantile mortality and morbidity     in Pakistan. It has detrimental effects on neurodevelopment of infants and may be     irreversible even after iron therapy(2). Type of cost effective interventions during     perinatal period for prevention of anemia in later infancy is limited. Delayed cord clamping     has a beneficial effect on prevention of anemia in later infancy because of increased iron     stores at birth(3. However there are controversies in incorporating delayed cord clamping     practice in the management of third stage of labour globally(4) Paucity of national     guidelines and lack of substantial data in Pakistan on this topic strongly necessitates such     study trials. This study may contribute to develop a protocol on the timing of cord clamping     which will be cost effective in prevention of iron deficiency anemia in the investigators     infantile population.      The investigators will conduct a randomized controlled trial and the investigators hypothesis     is that delayed cord clamping will result in higher hemoglobin (Hb), hematocrit (Hct) and     ferritin at third month as compared to early cord clamping.      OBJECTIVES:      A- Primary:        1. To study the effect of timing of umbilical cord clamping on hemoglobin (Hb), Hematocrit          (Hct) at birth, 48 hours and Hb, Hct and ferritin at three months of age.        2. To study the effect of timing of umbilical cord clamping on short term clinical profile          of neonates like jaundice, respiratory distress, anemia, polycythemia etc. during fist          24 to 48 hours of life.      B- Secondary:      To assess whether delayed cord clamping is associated with undesirable effects on mothers     followed till 48 hours postpartum.   "
247354|NCT01081990|"     The management of post-operative pain in patients after vaginal surgery provides many     unforeseen challenges. Although vaginal surgery is considered a minimally invasive approach     for the repair of pelvic floor prolapse and urinary incontinence, patients may still     experience varying degrees of discomfort and post-operative pain. Narcotics, however, can     introduce a host of problems in addition to the potential addictive properties of the     medication. A vicious cycle ensues as patients seek better pain control at the expense of     worsening constipation, but without adequate control of pain after surgery, voiding     dysfunctions are often exaggerated.      Cyclobenzaprine (Flexeril®) in conjunction with NSAIDs has long been the basis for management     of acute musculoskeletal injuries, but the practice of prescribing this centrally acting     muscle relaxant for post-operative patients has also been successful in the management of     pain.      An online search of medical databases revealed that there are currently no published     retrospective or prospective studies determining the efficacy of cyclobenzaprine in post     surgical patients in conjunction with traditional pain management. The investigators     hypothesize among healthy patients undergoing elective vaginal surgery for pelvic organ     prolapse, the short-term use of a muscle relaxant could reduce the spasticity of the pelvic     floor muscle attributable to surgery and thereby reduce the use of narcotics. Consequently,     the reduction of narcotics and the control of post-surgical pain may also hasten the return     of normal urinary and defecatory function.   "
247355|NCT01082003|"     The main purpose of this research study is to determine if the use of Trental and Vitamin E     will decrease the incidence and severity of contractures (shrinking and or hardening of     tissue surrounding the implant) associated with breast implant reconstruction following     radiation treatment. Another goal is to find out the impact that Trental and Vitamin E have     on implant loss or need for surgical intervention in the setting of chest wall radiation     after reconstruction. In addition, the investigators want to evaluate the patient's sense of     well being and quality of life.   "
247356|NCT01082016|"     Sleep deprivation in healthy volunteers is associated with immune dysfunction. This adverse     effect of sleep deprivation likely occurs in patients suffering from acute injury and     critical illness requiring intensive care unit (ICU) admission. Studies have demonstrated     that sleep in ICU patients is highly abnormal. The global hypothesis for this proposal is     that a strategy to promote sleep in ICU patients will increase time in rapid eye movement     (REM) and slow wave sleep (SWS). This three phase proposal examines the feasibility of a     sleep promotion strategy for injured and critically ill patients in the ICU.      Phase I (Development and Training): Develop an intervention manual for sleep promotion, Sleep     Enhancement Program (SEP), and train ICU staff.      Phase II (Validation and Safety): Implement SEP and test for protocol fidelity and safety.      Phase III (Efficacy): Conduct a pilot trail to determine efficacy of SEP to improve SWS in     ICU patients.   "
247357|NCT01082029|"     The accumulation of fluid behind the ear drum without any acute inflammation is known as     otitis media with effusion (OME). It is the most common cause of acquired hearing loss during     childhood. Long-term complications of OME include linguistic, developmental, and social     development delays due to hearing loss.      The cause of OME is not known; however, low grade infection of the middle ear, poor function     of the eustachian tube between the ear and the throat, and adenoid hypertrophy have all been     suggested as possible etiologies. Recent detection of the stomach enzyme pepsin in middle ear     fluid has led some to propose that OME is related to the reflux of stomach contents into the     ear, via the eustachian tube.      The purpose of the investigators study is to determine whether anti-reflux medication may     have a positive impact by clearing the accumulation of fluid in the middle ear with the aim     of preventing or reducing hearing loss in children diagnosed with OME. Empiric anti-reflux     therapy with proton pump inhibitor (PPI) medication is safe, proven and cost-effective. It is     used widely as a diagnostic and treatment strategy in the presence of the signs and symptoms     of gastroesophageal reflux disease (GERD). The signs and symptoms of GERD include heartburn,     recurrent vomiting or regurgitation, acid taste in mouth, throat irritation, voice problems,     heartburn, difficult or painful swallowing, asthma and recurrent pneumonia.      This pilot study will be a double-blinded, randomized, placebo-controlled trial that will     compare resolution rates for OME in children treated with lansoprazole or placebo for three     months. At the end of the study, those patients who have persistent middle ear effusions will     be brought to the operating room and have the fluid aspirated and sent for analysis for     pepsin.   "
247358|NCT01082042|"     This is a pilot study to assess whether balance training with the Nintendo® Wii is comparable     to a physiotherapist−led falls group in terms of improvement in balance. The acceptability of     the Nintendo® Wii will also be assessed.   "
247423|NCT01088204|"     The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted     distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.   "
247359|NCT01082055|"     Antiarrhythmic drugs are associated with significant side effect profiles. Amiodarone has     primarily class III action and whilst it has unrivalled efficacy in management of certain     arrhythmias, it has a formidable side effect profile. Complications of continued therapy     include, thyroiditis, hepatitis, cholestasis, increased skin sensitivity and pulmonary     fibrosis. Current prescribing guidelines recommend frequent blood tests to monitor kidney,     liver and thyroid function, in addition to frequent pulmonary function tests. Sotalol is a     betablocker which possesses class III action in high doses and may predispose to QT     prolongation Other class I agents such as flecainide and propafenone can be associated with     sudden cardiac death in certain populations, and may predispose to other arrhythmias.      This study will examine the incidence of discontinuation of AAD therapy and adverse events.   "
247360|NCT01082068|"     Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in     combination with letrozole (Femara) and of XL765 when given in combination with letrozole.     After the MTD is established for each combination (Phase 2), subjects will be enrolled to     evaluate the preliminary efficacy and safety of these combinations in subjects with breast     cancer refractory to a non-steroidal aromatase inhibitor that is ER+/PGR+ and HER2-.     Letrozole is used in the treatment of different types of breast cancer, but patients can     develop resistance.      Upregulation of PI3K activity is one of the most common characteristics of human cancer     cells, including breast tumor cells. Activation of PI3K results in stimulation of AKT and     mTOR kinases, resulting in the promotion of tumor cell proliferation and survival.     Preclinical and retrospective clinical data suggest that aberrant activation of the PI3K     pathway may play a role in aromatase inhibitor resistance in patients with ER+, HER2- breast     cancer. XL147 is a potent inhibitor of PI3K, and XL765 is a potent dual inhibitor of PI3K and     mTOR; therefore either of these compounds in combination with letrozole warrants clinical     investigation.   "
247361|NCT01082081|"     GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol     1000mg vs 500mg . The post-surgical dental pain model will be used to evaluate the analgesic     efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The     duration of the entire study will be approximately 16 weeks. Each subject will have to come     to the clinic for three visits (Screening, Treatment and Follow up visits).   "
247362|NCT01082094|"     The purpose of this Phase 1 study is to assess the safety, tolerability, and preliminary     efficacy of single escalating doses of ACRX-100 delivered via endomyocardial injection in     adults with ischemic heart failure.   "
247363|NCT01082107|"     SODISWATER is a European Union funded health impact assessment study investigating the effect     of sunlight to inactivate microbial pathogens in drinking water. This study was done by     observing whether children younger than 5 years old who drink solar disinfected water were     healthier than those who did not. Health was measured by how often the children had     diarrhoea.      Participants were given plastic bottles to place in the sun, water samples were then     collected from these plastic bottles to be analyzed. They were also requested to fill in     diarrhea diaries.      TESTABLE RESEARCH HYPOTHESES:      Health Impact Assessment: Children who use solar disinfected water will have:      (a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth     rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden     (g) increased school attendance   "
247364|NCT01082120|"     The purpose of this study is to determine whether administration of AZD1656 will affect the     pharmacokinetics of Pioglitazone and vice versa in patients with Type 2 Diabetes Mellitus.   "
247365|NCT01082133|"     The trial proposed is a multicenter treatment protocol designed to examine transplant related     events in patients with Fanconi anemia who lack matched sib donors have severe aplastic     anemia (SAA), or myelodysplastic syndrome(MDS) or acute myelogenous leukemia (AML).   "
247366|NCT01082146|"     This will be an open-label, non-randomized, absorption, metabolism, and excretion study of     Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a     postprandial state   "
247367|NCT01082159|"     This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar     Decompression with the Mild® devices in patients with symptomatic central canal spinal     stenosis.   "
247368|NCT01082172|"     A prospective, non-randomized multi-center clinical evaluation of the performance of the     TriVascular Thoracic Stent Graft System when used in the treatment of subjects with thoracic     aortic aneurysms (TAA).   "
247369|NCT01082185|"     A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal     Stent Graft System   "
247370|NCT01082198|"     RATIONALE: Vaccines made from dendritic cells and tumor antigen peptides or a person's tumor     cells may help the body build an effective immune response to kill tumor cells.      PURPOSE: This phase I/II trial is studying the side effects and best way to give melanoma     vaccine in treating patients with stage III melanoma after surgery to remove the lymph nodes.   "
247371|NCT01082211|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy after surgery kill any remaining tumor cells and may be an effective treatment for     breast cancer.      PURPOSE: This phase II trial is studying how well radiation therapy works in treating women     with locally recurrent breast cancer previously treated with repeat breast-conserving     surgery.   "
247372|NCT01082224|"     RATIONALE: Diagnostic procedures, such as contrast-enhanced CT scan and contrast-enhanced     MRI, may help find liver cancer and find out how far the disease has spread.      PURPOSE: This clinical trial is studying contrast-enhanced CT scan and contrast-enhanced MRI     in diagnosing and staging liver cancer in patients with chronic liver disease.   "
247424|NCT01088217|"     The purpose of this study is to investigate inherited genetic factors that play a role in the     development of familial pulmonary fibrosis and to identify a group of genes that predispose     individuals to develop pulmonary fibrosis. Finding the genes that cause pulmonary fibrosis is     the first step at developing better methods for early diagnosis and improved treatment for     pulmonary fibrosis. The overall hypothesis is that inherited genetic factors predispose     individuals to develop pulmonary fibrosis.   "
247425|NCT01088230|"     The purpose of this study is to see whether treating subjects for wrist rehabilitation     following stroke with Botox® and robotic therapy is more effective than treatment with     robotic therapy alone and no Botox®.   "
247373|NCT01082237|"     Major depressive disorder (MDD) is a common psychiatric illness with high cost to society and     individual patients. One reason for the high cost is that most patients endure lengthy and     ultimately unsuccessful empiric antidepressant trials before a successful medication is     identified by trial-and-error. Care would be improved if a biomarker could determine, early     in the course of treatment, whether a particular antidepressant would likely lead to     response, remission, or treatment failure. Physicians could rapidly change treatments to an     antidepressant which the biomarker indicated would be likely to help the patient. We have     identified quantitative electroencephalographic (QEEG) changes that emerge early in the     course of treatment with selective serotonin reuptake inhibitors (SSRIs) that appear to     predict later response and remission in a general adult patient population. Demographic     trends in the United States suggest that improved care for MDD will be essential for a     growing number of elderly with late-life depression. While the consequences of prolonged     trial-and-error periods to find a successful treatment are particularly inauspicious for     elders with late-life depression, this patient group has not been included in the past     studies which demonstrated the use of this biomarker approach in a general adult population.     We propose a 12-week treatment trial to evaluate a practical biomarker for predicting outcome     based on data from the first week of antidepressant treatment, with a focus only on     depression in late life (age ≥65).      There are three study Hypothesis:      H1) ATR prediction of treatment outcome in older subjects will show >70% accuracy.      H2) The predictive accuracy of the model will be enhanced by including clinical,     socio-demographic, and genetic predictors.      H3) The accuracy of ATR prediction will not show a significant dependence on subject gender.   "
247374|NCT01082250|"     A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl   "
247375|NCT01082263|"     A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.   "
247376|NCT01082276|"     The effect of rifampin on the pharmacokinetics of lurasidone   "
247377|NCT01082289|"     The objective of this study is to evaluate the pharmacokinetic profile of digoxin when     administered alone and when administered with repeated dose of lurasidone 120mg.   "
247378|NCT01082302|"     This open, monocentric study is designed to investigate plasma concentrations of certain     catechins after topical application of Veregen 15% ointment to genital or perianal warts in     comparison to catechin plasma concentrations after oral intake of a defined dose of green tea     beverage. The study is intended to demonstrate that topical administration of Veregen 15%     induces catechin plasma concentrations lower or equivalent to those that can be reached with     normal consumption of green tea.   "
247379|NCT01082315|"     After consultation with the Korean Health Authorities, the two Post-Authorization Safety     Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one     study protocol EMR 062202-551. This Post-Marketing Surveillance Study (PMS) EMR 062202-551 is     requested by the Korean Health Authorities to continue monitoring of Erbitux and provide     further information about safety and toxicity in clinical practice in at least 900 patients     during 6 years.      All data points from the EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) remain     unchanged in protocol EMR 062202-551. Therefore, the Sponsor has decided not to separately     disclose the EMR 062202-551 study titled A Korean Post-Marketing Surveillance Study On     Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic     Squamous Cell Cancer of the Head and Neck (originally EMR 62241-508) and in Patients With     EGFR-expressing, KRAS wild-type Metastatic Colorectal Cancer (originally EMR 62202-509) on     clinicaltrials.gov.   "
247380|NCT01082328|"     The primary objective of the study is to evaluate the proportion of responders (that is,     greater than or equal to [>=] 30 percent reduction from Baseline in blood phenylalanine [Phe]     level) to treatment with Kuvan® (sapropterin dihydrochloride) 20 milligram per kilogram per     day (mg/kg/day) for 28 days.   "
247381|NCT01082341|"     It is possible to safely protect human volunteers immunized with P. vivax irradiated     sporozoites from P. vivax challenge with live sporozoites.   "
247382|NCT01082354|"     This one-arm, multi-centric, non-randomized, observational, open label, prospective study was     designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians     in private, mixed private and hospital practice treated with Saizen.   "
247383|NCT01082367|"     This study investigated the efficacy of inhaled TOBI treatment for early infections of P.     aeruginosa in paediatric patients with cystic fibrosis.   "
247384|NCT01082380|"     The rationale for this study is to investigate the absorption, metabolism and excretion of     [14C]PF 02341066 and characterize plasma, fecal and urinary radioactivity, and identify any     metabolites, if possible, of [14C]PF 02341066 in humans.   "
247385|NCT01082393|"     We will investigate the process of vitiligo induction and the influence of different commonly     used cream treatments on this process. Studies comparing different treatments for vitiligo in     the induction stage of the disease are still missing. The study hypothesis = cream treatment     can stop actively spreading vitiligo lesions during the early induction stage of the disease.   "
247386|NCT01082406|"     This trial is conducted in Europe. The aim of this clinical trial is to compare the     metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different     manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.   "
247387|NCT01082419|"     Liver stiffness measurement (LSM) by non invasive methods is increasingly used to estimate     liver fibrosis in patients with chronic liver diseases. However, there is growing evidence     that fibrosis is not the only determinant of liver stiffness. Indeed inflammation,     cholestasis, congestion could also interfere with stiffness measurements. Acoustic radiation     force impulse imaging (ARFI) is a new technology to perform real time LSM. Using a standard     ultrasonographic probe, it offers elastography with a flexible metering box at variable     depth, allowing the examination of specific area.   "
247426|NCT01088243|"     The purpose of this study is to understand if a drug called mesalamine helps to control     inflammation associated with chronic beryllium disease (CBD). We hypothesize that in CBD     subjects treated with prednisone, mesalamine treatment will enhance the immunosuppressive     effects of prednisone, and thus reduce the immune response to beryllium.   "
247427|NCT01088256|"     The purpose of the study is to determine the efficacy of etoricoxib on pain patients. The     investigators assume that patients with neuropathic pain will have greater pain relief then     patients on placebo.   "
247428|NCT01088269|"     This is a cross-sectional study including patients with permanent atrial fibrillation.     Assessment will include:        -  clinic blood pressure measurements (mercury sphygmomanometer and automated oscillometric          device)        -  24-hour ambulatory blood pressure monitoring        -  determination of various serum markers and cardiac ultrasound.        -  evaluation of a 24h ambulatory blood pressure monitoring device (Microlife WatchBPO3) in          terms of its diagnostic value for the detection of atrial fibrillation compared with the          reference 24h Holter ECG   "
247388|NCT01082432|"     Background      One of the potentially debilitative complications of operative repair and subsequent     immobilization is stiffness that appears secondary to inflammation and adhesions. To prevent     such a physical impairment, active joint mobilization has shown to be efficient. However,     adhesions sometimes remain despite the therapy. Due to the viscoelastic nature of the     biological tissues, if a technique can enable to extend the muscle ability to impose a     maximal steady stress on adhesions, adhesion deformation should be greater and range of     motion deficit should be reduced. Within that context, the purpose of the present study was     to assess the real-time effects of superimposed electrical stimulation (SES) on maximal     voluntary muscular contraction (VOL) over time and to assess SES effects on range of motion     recovery in thumb stiff joint.      Methods and Findings      The aim of the first experiment was to examine the real-time effects of tetanic SES on the     maximal volitional level of force over repeated contractions of the triceps brachii muscle.     To address this goal, seventeen subjects participated voluntarily in this study. Two features     of the muscular force were assessed: The peak force (1) and the impulse (2). These two     dependent variables were measured during 500 sec - including 50 maximal force productions of     4 sec each- in two randomized conditions of VOL and SES. When considering the 50 trials as a     whole, exerted force was higher in the SES than in the VOL condition for both peak force and     impulse (P<.05). Over time, peak force and impulse decreased consistently in VOL starting     between the 20th and 30th trials whereas they were maintained in SES condition (P<.05).      The aim of the second experiment was to compare the effects of VOL and SES on the range of     flexion recovery of the stiff metacarpophalangeal joint following operative repair of the     ulnar collateral ligament of the thumb. To address this goal, eight patients participated     voluntarily. Range of motion, oedema and pain were assessed before and after the two     randomised conditions of VOL and SES.   "
247389|NCT01082445|"     The purpose of this study is to determine whether N-acetylcysteine is effective in the     treatment or prevention of the foot ulcers in diabetic patients.   "
247390|NCT01082458|"     Target concentration infusion(TCI) of remifentanil (2.0ng/ml) suppresses the cough induced by     endotracheal tube more effectively than intravenous administration of lidocaine (1.5mg/kg).   "
247391|NCT01082471|"     To compare the incidence and severity of nausea in the study treatment groups, during the     18-hour period starting 6 hours after titration to pain relief; following confirmation of the     assumption of non-inferiority between the two groups of pain relief over the 24 hour     post-operative period. Pain relief and nausea will be determined by measuring the areas under     the curves of pain intensity and nausea verbal rating scale scores.   "
247392|NCT01082484|"     The purpose of this study is to test whether prostacyclin analogues' cathodal iontophoresis     induce a cutaneous vasodilation in healthy volunteers's forearm, without local side effects.   "
247393|NCT01082497|"     The purpose of this study is to investigate whether a mindfulness based 8-week course for     stress reduction, known as MBSR course, given to all staff at an inpatient psychiatric ward     influences the level of stress and burnout and the psychosocial atmosphere at the ward.      The design is an intervention trial with repeated measures and control group.The focus is the     interaction between unit and individuals.      All staff at both wards were invited to participate. The intervention consists of 8 weekly     group meetings where the participants learn different ways of practicing mindfulness and do     home practice between the meetings. The control intervention is 8 weekly workshops in     affect-consciousness.      Data are collected through self-reporting questionnaires on mindfulness, work- and     health-related topics at six different points. The patients at both wards answers one     questionnaire about ward atmosphere at the same points.      Data wil be analyzed on SPSS statistic programme.   "
247394|NCT01082510|"     The purpose of this prospective randomized controlled study is to prove the non-inferiority     of UFT maintenance therapy to BCG maintenance therapy for preventing recurrences of     superficial bladder cancer.   "
247395|NCT01082523|"     The purpose of this study is to determine whether an automated electronic reminder system     using text messages sent to patient's cell phones will help patients with acne be more     compliant with their topical medications and lead to an improvement of their acne.      Hypothesis: Automatically delivered electronic reminders in the form of text messages will     increase acne patient adherence to topical medications and consequently result in better     treatment outcome and higher patient satisfaction   "
247396|NCT01082536|"     The purpose of this study is to use an experimental diagnostic tool(NIRS), combined with a     known screening tool (cranial ultrasound), to analyze and evaluate cerebral blood flow and     oxygenation, and determine if abnormal neurodevelopmental outcomes can be predicted and     potentially improved upon in pediatric patients undergoing repair for congenital heart     disease.   "
247397|NCT01082549|"     To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer     receiving the combination of gemcitabine/carboplatin either with or without Iniparib.      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
247398|NCT01087879|"     The impact of different administration routes of hormonal contraceptives on androgen     secretion, glucose metabolism and inflammation. A prospective randomized trial.      The investigators assume, that transdermal or transvaginal hormonal contraception would have     less effects on androgen levels, glucose metabolism and inflammatory markers than oral     contraceptives.   "
247399|NCT01087892|"     Antibiotics are currently required to treat patients in hospital when they have an infection,     but these antibiotics can cause side effects such as diarrhoea and in some patients a serious     form of gut infection with an organism called Clostridium difficile. This organism can     produce toxins in the gut causing a severe form of diarrhoea associated with a lot of ill     health, and in some circumstances can be fatal. Some studies have shown that yogurts' or     Probiotics' (special drinks with a defined concentration of useful bacteria) taken by     patients can have a beneficial effect in reducing the diarrhoea associated with antibiotics     use. The aim of the present study is to find out whether the use of one of these Probiotics     in hospitalised patients taking antibiotics will result in less diarrhoea, less Clostridium     difficile infection, as well as cost saving. The study will also analyze the effects of     probiotics on quality of life and length of hospital stay.   "
247535|NCT01099111|"     This clinical trial hypothesize that Gut Microbiota (bacteria, viruses, fungi)play a major     role in the occurrence and progression of many chronic gastrointestinal diseases like     Irritable Bowel Syndrome, Inflammatory Bowel Diseases and Colo-Rectal Cancer.      Hence, aims to study the spectrum of such microbiota in these patients as compared to normal     subjects, by utilizing metagenomic techniques rather than cultural methods.   "
247400|NCT01087905|"     Research shows that smoking cessation is the most significant preventable health behavior     change that a person can make to lower cancer risk. In addition, telephone quitlines are an     effective, science-based smoking cessation treatment that is universally accessible to     smokers in the U.S. However, little research has explored promising approaches that could     increase quitline use, improve quit rates, and inform resource allocation for quitline     services. The proposed study will test three promising enhancements to the standard quitline     treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication.     These enhancements are: 1) combination nicotine replacement therapy as recommended by the     United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and     Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling     addition - cognitive medication adherence counseling - to optimize adherence to cessation     medication. In addition, the cost-effectiveness of each intervention will be calculated. The     findings of the proposed research have broad potential application and relevance to state     quitlines, quitline service providers, and other purchasers of quitline services such as     employers and insurers. Additionally, the study findings can potentially inform other     telephone health behavior counseling programs.   "
247401|NCT01087918|"     The purpose of this pilot study is to investigate whether gait specific robotic supported     bodyweight supported treadmill training and lower extremity strength training have similar     beneficial effects on walking function and other outcomes.   "
247402|NCT01087931|"     The use of iliac crest bone graft (ICBG) remains the gold-standard in spinal reconstructive     surgery for achieving fusion. Major complications from the harvesting of ICBG are rare, but     chronic pain has been reported in 10-39%. Catheters implanted at the time of surgery have     been used to provide local anesthetic at the harvest site for 24-48 hours after surgery. This     has been shown to decrease chronic pain at 4 years post-operatively. A single application of     local anesthetic at surgery has been shown to decrease pain at the harvest site for up to 5     days. No study has demonstrated a benefit to using a single application of local anesthetic     at the ICBG site beyond 5 days. In current clinical practice, the use of a local anesthetic     at the ICBG site is determined according to surgeon preference. The purpose of this study is     to determine if a single application of bupivacaine at the ICBG site, as currently done in     some cases, provides any pain relief beyond 5 days such as that demonstrated with longer     infusions of local anesthetics.   "
247403|NCT01087944|"     This randomized, cross-over, open label study will compare the tolerability and handling of     application of peginterferon alfa-2a [Pegasys] by autoinjector versus pre-filled syringe in     patients with chronic hepatitis C, either on treatment with peginterferon alfa-2a for at     least 12 weeks or treatment-naïve for peginterferon alfa-2a. Patients will be randomized to     self-injection of 180mcg peginterferon alfa-2a once a week using either an autoinjector or a     prefilled syringe for 3 weeks, then switch to use the other method of injection for another 3     weeks. Anticipated time on study treatment is 6 weeks. Target sample size is <100 patients.   "
247404|NCT01087957|"     To establish equivalence or incremental benefit to standard of care Ankle-Foot Orthosis (AFO)     for patients with foot drop due to stroke, and to assess the functional improvement of     ambulation and improved activities of daily living.   "
247405|NCT01087970|"     The purpose of this study is to look for an improvement in progression free survival with the     combination of pemetrexed, carboplatin (or cisplatin) and cetuximab in participants with     recurrent or metastatic squamous cell carcinoma of the head and neck.   "
247406|NCT01087983|"     The goal of this clinical research study is to find the highest tolerable dose of 2 different     combinations of drugs that can be given to patients with advanced cancer. The first     combination of drugs is Tykerb (lapatinib) and Rapamune (sirolimus), and the second     combination is lapatinib and Glucophage (metformin). The safety of these drug combinations     will also be studied.   "
247407|NCT01087996|"     The technique of transplanting progenitor cells into a region of damaged myocardium, termed     cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or     repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily     available, easy to culture to ensure adequate quantities for transplantation, and able to     survive in host myocardium; often a hostile environment of limited blood supply and     immunorejection. Whether effective cellular regenerative strategies require that administered     cells differentiate into adult cardiomyocytes and couple electromechanically with the     surrounding myocardium is increasingly controversial, and recent evidence suggests that this     may not be required for effective cardiac repair. Most importantly, transplantation of graft     cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a     number of candidate cells have been transplanted in experimental models, including fetal and     neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile     grafts, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac     precursors residing within the heart itself. There has been substantial clinical development     in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both     post-infarction patients, and patients with chronic ischemic left ventricular dysfunction and     heart failure. The effects of bone-marrow derived mesenchymal stem cells (MSCs) have also     been studied clinically.      Currently, bone marrow or bone marrow-derived cells represent highly promising modality for     cardiac repair. The totality of evidence from trials investigating autologous whole bone     marrow infusions into patients following myocardial infarction supports the safety of this     approach. In terms of efficacy, increases in ejection fraction are reported in the majority     of the trials.      Chronic ischemic left ventricular dysfunction resulting from heart disease is a common and     problematic condition; definitive therapy in the form of heart transplantation is available     to only a tiny minority of eligible patients. Cellular cardiomyoplasty for chronic heart     failure has been studied less than for acute MI, but represents a potentially important     alternative for this disease.   "
247408|NCT01088009|"     The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy,     and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.   "
247409|NCT01088022|"     Title of the study Aprepitant for prevention of acute and delayed nausea and vomiting: a     phase III, double-blind, randomized, placebo-controlled trial in patients receiving a     high-emetogenic dose of cyclophosphamide for peripheral blood stem cells harvesting      Objective(s) Primary objective: to confirm and extend the investigators preliminary data on     the efficacy and safety of combined aprepitant, palonosetron and dexamethasone in preventing     CINV after high emetic therapy with cyclophosphamide 3 g/m2 compared with the palonosetron     and dexamethasone regimen.      Secondary objective: to monitor peripheral blood stem cell harvest. Methodology Single     centre, randomized, double-blind, placebo-controlled phase III trial Endpoints Primary     endpoint: the complete response (CR) rate defined as the number of patients with no emetic     episodes and no rescue medication in the first 120 hours post-chemotherapy.      Secondary endpoints:        -  CR rates for acute (0-24 h) and delayed (24-120 h) phases;        -  complete control rate (CC) defined as no emetic episode, no rescue medication use and no          more than mild nausea;        -  number of emetic episodes;        -  severity of nausea;        -  impact of CINV on daily life as measured by the Functional Living Index-Emesis (FLIE)          (total score > 108 = no impact);        -  peripheral blood stem cell harvest;        -  tolerability (adverse events, drug-related adverse events, serious adverse events;          discontinuation of treatment due to an adverse event). Adverse events will be classified          using NCI Common Toxicity Criteria.      Number of patients A total of 120 patients will be enrolled Inclusion criteria - Male or     female patients ≥ 18 years of age        -  Patient is able to understand study procedure and agrees to participate in the study by          giving written informed consent.        -  Patient is scheduled to receive a highly emetogenic cyclophosphamide IV chemotherapy (3          g/m2) for autologous PBSC harvesting        -  Karnofsky score ≥60        -  Normal laboratory values        -  Normal ECG        -  HBV-, HCV- and HIV- negative        -  Negative urine pregnancy test for women of childbearing age Treatment Eligible patients          will be randomized to receive oral doses of Aprepitant (125 mg day 1, 80 mg days 2 and          3), dexamethasone (8 mg/day for 3 days) and a single intravenous dose of palonosetron          (0.25 mg on day 1) versus placebo plus dexamethasone (8 mg/day for 3 days) and a single          intravenous dose of palonosetron (0.25 mg on day 1) Duration of study 3 years Criteria          for evaluation Efficacy and safety data will be obtained using the patient's daily diary          (days 1 through 5) reporting the number of episodes of retching and vomiting, severity          of nausea (using a categorical scale of none, mild, moderate or severe), and overall          quality of life. The FLIE 8 questionnaire will be completed on days 1 (before starting          chemotherapy) and 6 (after chemotherapy). All side effects attributed to this          combination therapy will be recorded daily.      Safety parameters: medical history, clinical examination and weight, vital signs, laboratory     tests (hematology, chemistry, urine analysis and urine pregnancy test for women of     childbearing age).      Statistical aspects Sample size was defined assuming the cumulative incidence rate of the     primary endpoint to be 68% in the treatment group and 41% in the control group. With balanced     allocation in the two groups, considering a two sided test with α=0.05 and ß=0.20 a total of     110 patients is needed. As few withdrawals and drop-outs are expected a total of 120 patients     will be enrolled.      Intention to treat approach will be used for all efficacy analysis. The primary endpoint will     be analysed by binomial logistic models. The dependent variable will be vomiting yes/no     during the first 120 hours after chemotherapy. Anti-emetic treatment, gender and age will     enter as explicative variables.      Dichotomous secondary endpoints will also be analysed by binomial logistic models.     Multinomial logistic models will analyze the severity of nausea, stratified in 4 classes.      Generalized Linear Models will investigate quantitative variables such as number of retching     or vomiting episodes and peripheral blood stem cell harvest.      In all tests, p value <0.05 will be considered statistically significant. No interim analyses     are planned.   "
247470|NCT01096264|"     Arterial stiffness is associated with increased risk of cardiovascular events and death.      Most of existing technique need dedicated device for arterial stiffness evaluation and     indirect calculation of intra arterial pressure. Supersonic Shear Imaging (SSI) is a novel     non-invasive technique based on remote palpation of biological tissues that can image with     very high temporal resolution (up to 10,000 images/s) and quantify the local viscoelastic     properties of tissues. The investigators goal was to apply this SSI technique for arterial     stiffness evaluation and local pulse wave velocity (PWV) calculation.      As a first step, the primary goal of this study is to establish normal values of local pulse     wave velocity and arterial stiffness (carotid and femoral) by SSI on hundred healthy     volunteers.   "
247536|NCT01099124|"     The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in     advanced NSCLC.   "
247410|NCT01088035|"     This is a phase II study evaluating the feasibility of concurrent carboplatin given with     focal radiation therapy in children age 12 months to < 21 years with newly diagnosed     localized ependymoma who have no or minimal residual disease post-operatively (< 0.5 cm). The     hypothesis is that utilizing carboplatin as a radiosensitizer is feasible and tolerable and     may improve event-free survival (EFS) and minimize local recurrences as compared to historic     controls. Following a neurosurgical resection and staging, patients who meet the eligibility     criteria will receive standard fractionated radiation therapy at doses of 54 to 59.4 Gy to     the primary site depending upon age. All patients will receive 35 mg/m²/day of carboplatin     prior to each fraction of radiotherapy. Although significant neutropenia is not anticipated,     G-CSF will be administered per study guidelines during radiation if neutropenia occurs. All     patients will be followed for toxicity, response (resolution of residual disease) and     event-free survival (EFS). Patients' tumor sample, blood and cerebro-spinal fluid (CSF) will     also be prospectively evaluated to quantify the level of Survivin, a known inhibitor of     apoptosis, via immunohistochemistry, Western Blot Analysis (in tumor tissue) and ELISA (in     blood and CSF). The feasibility of obtaining these levels prospectively and in real time will     be evaluated.   "
247411|NCT01088048|"     This study will evaluate the safety and clinical activity of idelalisib in combination with     an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, an mTOR inhibitor, a     protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants     with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma     (MCL), or chronic lymphocytic leukemia (CLL).   "
247412|NCT01088061|"     The purpose of the study was to investigate adipose expression and plasma levels of different     adipocytokine, which may play a role in the pathophysiology of PCOS. The investigators     investigated lean and obese women with and without PCOS.   "
247413|NCT01088074|"     The aim of the study is to compare incision closure techniques for total knee replacement     using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort     to identify the best approach with respect to time efficiency, cost, durability, dehiscence,     microbial resistance and cosmesis.      The hypothesis is that the combined suture/adhesive approach (sutures for capsule and     subcutaneous layers, and tissue adhesive for the final cutaneous layer) or suture/staple     approach will be significantly faster and of comparable durability as the conventional     exclusive suture approach (sutures used for the capsule, subcutaneous, and cutaneous layers).     This is a prospective, randomized, controlled, single site, unblinded (open label) study.   "
247414|NCT01088087|"     Chronic alcohol ingestion is related with leaky gut syndrome. Colostrum is well-studied that     it has a effect of decreasing the degree of leaky gut syndrome.      So the investigators are planning to find out whether Colostrum has a effect of decreasing     the degree of leaky gut syndrome.   "
247415|NCT01088100|"     The purpose of this study is to determine whether a certain clock-gene (HPER3) with the 5/5     genotype carries a higher risk of post-operative cognitive dysfunction.   "
247416|NCT01088113|"     The objective of this study is to investigate the effect of Tai Chi and Qigong practice on     cranial oxyhaemoglobin level, blood pressures and autonomic nervous system responses.   "
247417|NCT01088126|"     The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not     established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial     tachyarrhythmias (AT). The investigators hypothesized that linear ablation extending the     clusters of CFAE would be a better strategy than focal ablation at the individual CFAE sites.   "
247418|NCT01088139|"     This is a randomized controlled, observer blinded trial to study the beneficial effect of     nutritional supplementation in elderly Hong Kong patients after hip fracture surgery during     rehabilitation and at 4 weeks follow up. The control group will receive Calcium and Vitamin D     supplementation whereas the intervention group will receive a moderately high dose protein     nutritional supplementation in addition to Vitamin D and Calcium. Both groups undergo the     same rehabilitation program and dietary counseling before discharge. They are followed up 4     weeks after discharge or completion of supplementation. The outcome parameters are     nutritional parameters and rehabilitation outcomes.   "
247419|NCT01088152|"     Swedish celiac disease women living on a gluten-free diet for years report poorer subjective     health and more bowel complaints than Swedish women of same age in general population.      The investigators hypothesis is that the women participating in an education programme based     on problem based learning will show higher degree of perceived health than the women     receiving usual care.   "
247420|NCT01088165|"     Psoriasis vulgaris is no longer considered as a chronic inflammatory disease restricted to     the skin. Evidence has accumulated in the past that psoriasis is a chronic inflammatory     systemic disease. As in rheumatoid arthritis, the chronic inflammatory process plays a     central role in the pathogenesis of associated comorbidities such as diabetes and     cardiovascular disease. Since several years the armamentarium of psoriasis treatment has been     broadened by the availability of TNF alpha blockers. These neutralize systemic TNF alpha     which not only plays a central role in the pathogenesis of psoriasis but has also been linked     to inflammatory pathways in diabetes and cardiovascular disease. While a few studies have     investigated the positive effects of TNF alpha blockers on associated cardiovascular disease     in rheumatoid arthritis patients, no research data exist on the effects of these therapeutic     agents in patients with moderate to severe chronic plaque psoriasis.      The present study aims at determining the effects of adalimumab, a potent and frequently     prescribed TNF alpha blocker for the treatment of psoriasis, on different diabetic and     cardiovascular risk factors in patients receiving this treatment as a remedy for moderate to     severe plaque type psoriasis. The study is designed to explore whether adalimumab is capable     to prevent or modulate psoriasis-associated comorbidities by blocking systemic inflammation.     The effects of adalimumab will be compared with those of fumaric acids, which represent an     established traditional systemic treatment option for moderate to severe psoriasis.      Study hypothesis:      Therapy with adalimumab will lead to an improvement of several parameters that reflect the     risk for diabetes and cardiovascular disease in patients with chronic plaque psoriasis due to     chronic inflammation. Endothelial dysfunction, as assessed by ultrasound flow mediated     dilatation, will serve as primary outcome measure. Other risk factors such as blood lipids,     hsCRP, IL-6, endothelial adhesion molecules, parameters of glucose metabolism and carotid     intima-media thickness will be secondary outcomes.      Aim:      If adalimumab and/or fumaric acids will show a significant impact on the above mentioned     parameters, these findings would offer a new perspective for the long term management of     psoriatic patients and their comorbidities.      Study design: Randomized, prospective, controlled, parallel group study      Study population: 66 patients   "
247421|NCT01088178|"     The investigators study is a prospective randomized trial of women undergoing the     levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods:     immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early     post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval     (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in     preparation for a multicenter, prospective randomized study of long-acting reversible     contraception in the postpartum period.   "
247429|NCT01088282|"     Surgical correction of presbyopia is possible via the implantation of multifocal intraocular     lenses after removal of the crystalline lens. The cost of these implants is approximately 6     times higher than the conventional monofocal implants routinely used in all crystalline     surgery for correction of the resulting ametropia. Spectacles for correcting presbyopia,     which are necessary after the insertion of monofocal implants, may also have a significant     cost.      The proposed trial will involve two randomized groups of patients in need of     crystalline/cataract surgery, with monofocal or multifocal lens implants (the same type of     lens in both eyes) leaving them emmetropic for distant vision.      The objective is to corroborate with blind-evaluation the effectiveness of multifocal lens     implants in obviating the need for glasses to correct presbyopia, to evaluate the benefits of     this type of implant, both in global economic terms (adding the cost of the implants to that     of corrective glasses where necessary) and in terms of the improved quality of life of the     patients, and to confirm the absence of adverse effects.      Findings will be subjected to a statistical quantification.   "
247430|NCT01088295|"     This is a research study to see whether fat accumulation either under the skin or in the     body's organs, for example, the liver, improves in men and women who take a drug called     telmisartan. The investigators will be looking at how the amount of fat in the body changes     when HIV-positive persons on effective anti-HIV therapy take telmisartan. The investigators     will be using a CT scan to make this comparison. Telmisartan is not an HIV medication. It is     a medication used to treat blood pressure, but has been shown to decrease fat in the organs     in people both with and without high blood pressure. The study involves 8 visits over a     period of about 24 weeks.   "
247431|NCT01088308|"     This research study is a prospective, single-center, feasibility study designed to assess the     possibility to detect hemodynamic changes during tachycardia episodes using tissue perfusion.   "
247432|NCT01088321|"     The purpose of this study is to compare the incidence rates of infection among patients with     rheumatoid arthritis who are treated with abatacept and those who are treated with other     anti-rheumatic medications   "
247433|NCT01088334|"     Background      Patients with an idiopathic venous thromboembolism (IVTE) appear to have a risk of     approximately 10% for symptomatic malignancy within 3 years after the IVTE. It is not clear     if extensive screening for malignant disease leads to survival benefit in patients with an     IVTE.      The SOMIT study learned that it is feasible to screen patients with an IVTE for malignancy     and screening by means of a computer tomography (CT) of the chest and abdomen plus a     mammography in women had the potential to be most cost-effective. The SOMIT study could not     show a survival benefit due to the design of the study.      Primary objective: cancer related mortality      Methods:      The Trousseau study has been designed as a multicenter, prospective concurrently controlled     cohort study.      Inclusion criteria:        1. Proven first symptomatic deep venous thromboembolic event;        2. Without: known risk factor for venous thromboembolism.      Exclusion criteria:        1. Proven deep venous thromboembolic event in the medical history, age under 40 years;        2. Patients without signs of malignancy after routine investigations (medical history,          physical examination, laboratory investigations and chest X-ray) were included.          Depending on the standard care in the hospital of interest, one group of patients has          been screened by means of CT-chest and abdomen plus mammography, the other group had no          additional investigations. Follow-up was aimed to be 3 years in both groups (at 3, 6,          12, 24 and 36 months after the thromboembolic event).      Data like mortality rate, morbidity due to screening procedures, additional investigations,     number of cancer patients detected by the extensive screening, number of cancer patients     three years after the IVTE, number and kind of investigations performed and information about     cancer treatment and hospitalization was collected. If this information indicate a survival     benefit these data enable us to perform a cost-effectiveness analysis.      Endpoint: Mortality.      Statistics:      Based on the prevalence of occult malignancy in VTE patients, the nature and stage of     malignancies, the expected mortality, the anticipated detection of cancers and the early     treatment related decrease in mortality we needed, in order to detect a true difference of     this size with a 80 percent power and a two-tailed certainty of five percent, 750 patients     for each group. Therefore, a total of 1500 patients is required for this study.   "
247434|NCT01088347|"     Chemoradiotherapy has become the standard of care for women with locally advanced cervical     cancer. The available data support a 30 to 50% reduction in the risk of death from cervical     cancer for women with locally advanced disease undergoing radiotherapy (RT) and concomitant     cisplatin-based chemotherapy compared to RT alone. Despite the fact that this is currently     the best treatment of locally advanced cervical cancer, 5-year overall survival is still only     52%.      The fully human, agonist monoclonal antibody mapatumumab binds to the Tumor necrosis     factor-Related Apoptosis-Inducing Ligand Receptor 1 (TRAIL-R1, DR4) and induces cytotoxicity     in multiple tumor cell lines in vitro and in vivo. In multiple phase I and phase II studies,     mapatumumab appeared to be safe both as single agent and in combination with chemotherapy,     including cisplatin.      In cervical cancer cell lines, mapatumumab induced apoptosis in 51% of the cells. Mapatumumab     in combination with irradiation increased apoptosis to 83%.      In this phase 1b/2 study, the investigators will evaluate the safety, tolerability and     efficacy of mapatumumab in combination with cisplatin and radiotherapy in patients with     locally advanced cervical cancer.   "
247435|NCT01088360|"     The purpose of this study is to compare the incidence rates of targeted infections,     malignancies and mortality among patients with rheumatoid arthritis who are treated with     abatacept and those who are treated with other anti-rheumatic medications.   "
247436|NCT01088373|"     Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine     and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is     currently tested in non del 5q MDS patients. Preliminary results have been recently presented     at ASH meeting (Sekeres et al, 2007).      Overall, the combination of Lenalidomide and Azacitidine is well-tolerated and early results     suggest some efficacy in advanced MDS without del 5q.      In this trial, we will combine Lenalidomide to Azacytidine in higher risk MDS with del (5q).      Patients will receive azacitidine( 75mg/m2/day for 5 days every 28 days) combined to     escalating doses of lenalidomide (starting at relatively low dose).      For patients in hematological CR, PR, HI or marrow CR after cycle 2 or 4, it is mandatory to     continue on Azacitidine + Lenalidomide as long as there is no unacceptable toxicity or overt     progression, with the schedule that yielded response.      In patient still responding after 52 weeks, the drug will continue to be supplied, and follow     up until death will be continued in all patients.   "
247437|NCT01088386|"     The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative     outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS).   "
247547|NCT01099267|"     Multi-center, survival data collection in subjects previously enrolled in study NCT00065156     (Celgene Protocol CC-5013-MDS-003).   "
247948|NCT01102686|"     The objectives of this clinical trial are to assess the safety and tolerability, as well as     efficacy, of a stepwise dosing regimen of pyrimethamine, starting at 25 mg/day, given as a     single dose daily for 4 weeks in patients affected with chronic Tay-Sachs or Sandhoff     variants.   "
247438|NCT01088399|"     The Hypopituitary Control and Complications Study HypoCCS is a prospective, open label,     global, multicentre, observational study on routine clinical care of adults with growth     hormone deficiency occurring either isolated or in combination with other pituitary hormone     deficiencies. The objective of this observational study is to evaluate long-term safety and     health outcomes for adult growth hormone deficient participants with or without somatropin     replacement therapy. As an observational study, data are collected only as provided at the     discretion of the attending physician. The participant enrolled meet the criteria of growth     hormone deficiency in adults as per the Humatrope label in the country where their attending     physician practices, and this diagnosis is at the discretion of the attending physician. The     decision to receive somatropin or remain untreated is made by the participant in consultation     with their attending physician.      While treatment of adult growth hormone deficient participants with somatropin has been shown     to be safe and effective in clinical trials of 18 months duration, this observational study     aims to provide information on health outcome and replacement therapy over longer periods of     time for a larger number of participants in the context of the overall disease environment.   "
247439|NCT01088412|"     GeNeSIS is an open-label, multinational, multicenter, observational study to evaluate the     safety and effectiveness of Humatrope treatment.      GeNeSIS is a modular program that includes:        -  Core study: Evaluating the safety and effectiveness of Humatrope in the observational          setting        -  Genetic Analysis Sub-study: Investigating the genetic defects underlying growth hormone          (GH) deficiency and non-GH-deficient growth disorders        -  Growth Prediction Sub-study: Working to validate and refine specific models to          accurately predict growth response to GH        -  SHOX Deficiency Sub-study: Elucidating the clinical, endocrine and radiological features          of patients with SHOX deficiency due to loss of, or mutation in the SHOX gene (including          patients with Turner syndrome)        -  Neoplasia Sub-study: To characterize the natural history of neoplastic disease,          especially in relation to recurrence/progression of primary neoplasia or development of          secondary neoplasia in children with a history of neoplasia   "
247440|NCT01088425|"     Great scientific effort has been made to improve practical as well as economical procedures     of modern assisted reproduction.      In the last years a shift from the well established method of slow-rate freezing to     vitrification of 2PN zygotes and embryos could be observed. Like any other method of     cryopreservation, the outcome of vitrification will be affected by several factors related to     technique itself, its practical management and patient characteristics.      The investigators want to investigate the influence of vitrification on the outcome of of 2PN     oocytes, pregnancy and infant health.      A Comparison between a cohort of spontaneous conceived children and children of vitrified and     slow- cooled 2PN oocytes is planned.   "
247441|NCT01088438|"     During the project, fourth-year medical students participating in a Medicine sub-internship     will be randomized to an intervention group or a control group; the intervention group will     receive additional training in the application of qualitative methodology to elicit and     incorporate contextual factors in the clinical encounter. All students will participate in an     SP assessment consisting of four standardized patients (SPs), blinded to trial arm,     presenting cases with and without important biomedical and contextual factors in a     counterbalanced factorial design. Performance will be compared between trial arms; the     investigators hypothesize better performance in the intervention arm. In addition,     performance will be compared with United States Medical Licensing Exam (USMLE) Step 2     clinical knowledge scores to determine whether contextualizing ability is independent of     clinical knowledge, and consistency of performance across individual SP cases will be studied     to determine the number of cases necessary to achieve sufficient reliability for the     assessment to be used.   "
247442|NCT01088451|"     Postprandial glycemic control is essential for diabetes compensation. Insulin pump therapy     control blood glucose released in response to both high and low glycemic index carbohydrates     in a mixed diet using normal, square and dual-wave boluses. The investigators hypothesize a     mixture of rapid insulin analogue and human insulin has the same effect.      This pilot prospective cohort study replaces basal-bolus therapy of diabetic subjects by     combined prandial application of insulin aspart and human insulin. Mixed-meals with high,     both high and low and low glycemic index carbohydrates are covered by 3:1, 1:1 and 1:3 ratios     of analogue to human insulin mixture. Subjects are followed by continuous glucose monitor for     six days (Phase One), changing between the experimental or their standard protocol for     insulin injection on consecutive days. The outcome was measured by comparing average glycemia     and areas under the curve of sample meals, which are doughnut, pizza and mixed vegetable     salad. The next three-to-four week period of therapy was evaluated by glycated hemoglobin     before and after the intervention (Phase Two).      Expected outcomes are postprandial and complex improvement of diabetes control, similarly to     the insulin pump therapy.   "
247443|NCT01088464|"     This study is to establish the safety and pharmacokinetic (PK) profile of IMC-11F8,     administered either: (1) in a 3-week cycle; or (2) in a 2-week cycle to Japanese participants     with advanced solid tumors who have not responded to standard therapy or for whom no standard     therapy is available.   "
247444|NCT01088477|"     In 50 breast cancer patients, heavily pretreated with anti-hormonal therapy, the     investigators will evaluate the use of 16-alpha[18-fluoro]-17beta-estradiol positron emission     tomography (FES-PET)as predictive biomarker for response to estrogen therapy.   "
247445|NCT01088490|"     Hydrogen sulfide (H2S), better known as a poisonous gas, has emerged as the third gaseous     transmitter in mammals, next to nitric oxide (NO) and carbon monoxide (CO). Increased     production and higher serum concentrations were shown in inflammatory diseases, septic shock     and stroke. The investigators will test the hypothesis that higher serum H2S concentrations     on admission to intensive care unit (ICU) are linked with higher mortality in patients with     shock of any reason.   "
247474|NCT01096316|"     Major depressive disorder (MDD) is a common disabling illness that disproportionately affects     women, with prevalence rates two times those of men. In addition to suffering, MDD has been     shown to have a marked effect on social and vocational functioning, with increased     disability, lost productivity, and excess mortality. Women with MDD have an increased     prevalence of comorbid anxiety disorders and medical conditions.      Our model of care utilizes a social worker as a depression care manager (DCM) to support both     patients and physicians in optimizing care in the OB-GYN clinical setting. This intervention     will be compared to usual care for depression.   "
247446|NCT01088503|"     The TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and     Events after Acute Coronary Syndrome (TRANSLATE-ACS) study is a prospective, observational     longitudinal study to evaluate the real world effectiveness and use of prasugrel and other     ADP receptor inhibitor therapies among myocardial infarction (MI) participants treated with     percutaneous coronary intervention (PCI) during the index hospitalization. Participant     management and treatment decisions are at the discretion of the care team per routine     clinical practice. Approximately 17,000 participants will be enrolled at approximately 350     sites in the United States. Follow-up will be conducted through 15 months in approximately     15,650 participants.      TRANSLATE-ACS will complement the results of both randomized controlled clinical trials and     current registries in addressing the real world treatment patterns and clinical outcomes for     MI participants managed with PCI and initiated on ADP receptor inhibitor therapy. In addition     to determining the effectiveness of prasugrel in comparison to other ADP receptor inhibitors,     the study will also determine factors associated with initial ADP receptor inhibitor     selection and longitudinal patterns of use, evaluate the safety, and describe and compare     resource use and medical costs associated with ADP receptor inhibitors. Additionally, this     study will generate a continuum of information from the inpatient to outpatient settings to     provide a comprehensive picture of participant treatment and outcomes not currently available     for novel ADP receptor inhibitors.   "
247447|NCT01088516|"     Therapeutic options to prevent vertical transmission of HIV remain limited. Combination     antiretroviral therapy in the form of HAART (Highly Active Anti Retroviral Therapy) is     generally recommended in the developed world, both for its ability to reduce maternal viral     load, and thus the likelihood of transmission, as well as for its prevention of drug     resistance mutations, which might otherwise reduce future options for therapy in the mother,     infant, or both. Exclusive formula-feeding is also recommended in the developed world (where     clean water sources & adequate hygiene is reliably available) to prevent HIV transmission     through breastmilk, however, this is not yet a feasible option in many developing world     settings due to economic, infrastructure, social and infant-health reasons.      The investigators propose use of a HAART regimen during pregnancy and breastfeeding that is     based upon the recently released Aluvia tablets (tablet form of LOPINAVIR/RITONAVIR or LOP;     established capsule form is known as Kaletra) to improve maternal virological control and     thus mother-to-child-transmission (MTCT).      Hypothesis: Maternal use of HAART containing Zidovudine, 3TC and Aluvia (Lopinavir/Ritonavir)     can prevent antepartum, and intrapartum transmission of HIV, as well as allow exclusive and     then subsequent complementary feeding to be carried out with minimum risk to the mother and     infant.        -  Study regimen: ZDV/3TC (combivir) + 2 Aluvia Tabs all PO BID to start at 14-30 weeks          gestational age (GA) and continue through labor and as long as the mother breastfeeds        -  Peripartum single dose Nevirapine (sdNVP) (Note: Mothers will also be receiving ZDV as          part of the study regimen) to mother and sdNVP + 5 days postpartum ZDV to the infant          will be given as per current Zambian practice        -  Exclusive breastfeeding (EBF) x 6 months then complementary foods to be added, with aim          for a gradual wean of breastfeeding by infant age of 12-13 months. In case of inability          to wean by 13 months, however, drug will be continued until the mother has achieved a          complete wean.        -  Follow-up period: Mother & child will be followed to an infant age of 24 months, as per          schedule-of-visits (approx every 3 months)      Major outcome measure: infant survival and negative dbs (dried blood spot) PCR 3 months post     weaning.   "
247448|NCT01088529|"     The goal of this clinical research study is to find out how treatment with abiraterone     acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH)     analogue changes the tumor in comparison to treatment with an LHRH analogue alone.      Objectives:      Primary Objective:      To assess the difference in pathologic stage < pT2 between Group A and Group B.      Secondary Objective:        -  To assess and compare the changes in levels of androgens (pre, during, and post          treatment) in the serum, primary tumor microenvironment and bone marrow between Group A          and Group B.        -  To assess changes in biomarkers related to androgen signaling and other cancer-related          pathways between Group A and Group B.        -  To assess the difference in rate of positive surgical margins between Group A and Group          B.        -  To assess the safety profile of abiraterone acetate and low dose prednisone in a          preoperative setting.   "
247449|NCT01088542|"     The Community Youth Development Study is an experimental test of the Communities That Care     (CTC) prevention planning system. It has been designed to find out if communities that were     trained to use the CTC system improved public health by reducing rates of adolescent drug     use, delinquency, violence, and risky sexual behavior when compared to communities that did     not use this approach. The primary purpose of the current continuation study is to     investigate whether CTC has long-term effects on substance use, antisocial behavior, and     violence, as well as secondary effects on educational attainment, mental health, and sexual     risk behavior in young adults at ages 21 and 23.   "
247450|NCT01088555|"     Sodium thiosulfate may be useful to prevent recurrence of calcium-containing kidney stones.     It will be studied in people with high amounts of urine calcium.   "
247451|NCT01088568|"     The objective is to conduct a contralateral prospective clinical study to compare the safety,     efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens     TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of     myopia with astigmatism.   "
247452|NCT01088581|"     Several adjuvant therapies have been attempted to reduce uni-centric, and intra- or     extrahepatic recurrence after curative surgical resection for hepatocellular carcinoma (HCC).     However, because the efficacy of such adjuvant therapy remains unclear, there is no standard     postoperative therapy.      The investigators investigated whether adjuvant hepatic arterial infusional chemotherapy with     5-fluorouracil (5-FU) and cisplatin reduces the recurrence of HCC after curative resection.   "
247453|NCT01088594|"     A single centre, open, randomized, placebo controlled, 3 period cross-over study to evaluate     the effects of single oral doses of pioglitazone 45mg, rosiglitazone 8mg and placebo on     urinary sodium excretion in 12 healthy male volunteers   "
247471|NCT01096277|"     Glucagon-like peptide 1 (GLP-1) is a 30-amino acid gut hormone secreted in a     nutrient-dependent manner that stimulates insulin secretion and inhibits glucagon secretion     and gastric emptying, thereby reducing postprandial glycemia.1,2 GLP-1 is derived from     posttranslational proteolysis of preproglucagon, and its peptide sequence is identical in     mouse, rat, and human.2,3 After secretion from enteroendocrine L cells, GLP-1(7-36) amide is     rapidly degraded by dipeptidyl peptidase-4 (DPP-4) to its N-terminally truncated metabolite     GLP-1(9-36), which does not interact with the known GLP-1 receptor.4,5 The diverse actions of     GLP-1 include the proliferation, differentiation, and protection from apoptosis of pancreatic     β cells and the induction of satiety. GLP-1 also improves memory and learning, stimulates     afferent sensory nerves, and has neuroprotective functions.1,6 Furthermore, GLP-1 receptor     agonists have been reported to have cardiac and vascular actions in rodents and humans that     include effects on contractility, blood pressure, cardiac output,7-10 and     cardioprotection.11-14   "
247454|NCT01088607|"     Primary sclerosing cholangitis (PSC), although uncommon, is a devastating and insidiously     progressive liver disease, resulting from advancing inflammation, fibrosis and obliteration     of the bile ducts in the liver, leading to cirrhosis and end-stage liver disease. Although     prognosis in children may be somewhat better than that of adults, approximately one third of     pediatric patients require transplantation by adulthood. Other than transplantation, there is     to date no therapy conclusively proven to improve the long-term outcome. Ursodeoxycholic acid     (UDCA) improves biochemical markers of liver disease, although in high doses does not clearly     improve the long-term outcome in adults, and in a recent study may have actually worsened     outcome. Childhood PSC is different from that of adult PSC in many ways, and children may     derive more short-term, as well as long-term, benefit than adults. This unique multicenter     study will carefully monitor the effects of withdrawal and restarting UDCA on liver injury     and inflammation in children with PSC. The preliminary data will help in the design of a more     definitive larger study to determine if UDCA has a beneficial role in the treatment of PSC in     children. Funding Source - FDA OOPD   "
247455|NCT01096069|"     There is a correlation between the CD55, CD59, CD35 and CD46 expression on B lymphocytes of     patients before and after treatment with rituximab and the level of depletion and     repopulation time for these cells. The theoretical rationale of the study assumes that the     correlation, if any, will be a negative correlation. However, the hypothesis of positive     correlation (two-tailed test) will also be tested.   "
247456|NCT01096082|"     Design: Phase II-III, double-blind, parallel, placebo controlled randomized Clinical trial      Background: Spinocerebellar ataxia type 3 (SCA-3) is an autosomal dominant adult-onset     neurodegenerative disorder for which there is no current treatment. Patients will invariably     become dependent from others and unable to walk during the disease course.      Hypothesis: Lithium Carbonate is safe and effective in treating neurological symptoms and     improving quality of life of patients with SCA3.      Outcomes:      Primary        -  Phase 2 - To assess safety and tolerability of Lithium Carbonate in patients with SCA3          after 6 months of follow-up        -  Phase 3 (if Phase II study shows safety of therapy) - To assess efficacy of Lithium          Carbonate in patients with SCA3 through the Neurological Examination Score for SCA 3          (NESSCA) after 12 months of follow-up .      Secondary        1. - To assess efficacy on neurological function, ataxic, depressive and quality of life          scores of Lithium Carbonate in patients with SCA3 through the Scale for the Assessment          and Rating of Ataxia (SARA), 9-Hole Peg Board test, 8m walking time, PATA repetition          rate, Click Test, SCA Functional Index (SCAFI), Composite Cerebellar Functional Score          (CCFS), Beck Depression Inventory, Barthel Index and WHOQol after 6 and 12 months of          follow-up.        2. - To assess the effect of Lithium Carbonate in peripheral levels and expression of          treatment biomarkers (BDNF, NSE, HDAC, GSK-3Beta)      Study Duration: 12 months        -  Final analysis of phase 2 (safety study) at 6 months with continuous monitoring until          the end of phase 3 (efficacy study).        -  Preliminary analysis of efficacy on ataxia scales at 6 months of study and final          analysis of phase 3 at 12 months.      Obs: A futility analysis will be performed after 12 months of therapy if no statistically     significant difference between groups were found. This analysis will define if the study will     continue until 18 or 24 months of follow-up or will be ended at 12 months.      Location: Hospital de Clínicas de Porto Alegre      Subjects: 60 molecularly diagnosed SCA3 patients from the outpatient unit of the Medical     Genetics Service of Hospital de Clínicas de Porto Alegre      Intervention: Lithium Carbonate tablets of 300mg. Starting dose will be 300mg/day with drug     titration during 49 days or until achieving the defined target lithium serum level of 0.5 to     0.8 mEq/L   "
247457|NCT01096095|"     DESIGN: Pilot, Phase II, double-blind, placebo-controlled study      JUSTIFICATION: In the literature one does not find a pharmacological treatment that changes     the natural history of Spinocerebellar ataxtia type 3 (SCA3). Patients with this disease     invariably become dependent.      OBJECTIVES I. To determine safety and tolerability of phenylbutyrate in patients with SCA3.      II. To provide early subsidies on the efficacy of phenylbutyrate in SCA3.      DURATION: 12 months of a double-blind study.      PLACE OF REALIZATION: Hospital de Clínicas de Porto Alegre, Brazil.      NUMBER OF PATIENTS: 20 patients.      CONCOMITANT MEDICATIONS: There are no concomitant medications that are prohibited unless they     affect safety parameters of this study (hemogram and platelets; fasting serum glucose, AST,     ALT, Gamma-GT, Bilirubins, Prothrombin time, Creatinine, Urea, Na, K, chlorides and arterial     gasometry; electrocardiogram and echocardiogram).      MEDICATIONS UNDER INVESTIGATION: Powdered sodium phenylbutyrate in sachets containing each     3g. At the start of the study, the dose will be 15g/day (five sachets) and may be reduced in     case of mild adverse events.      OUTCOMES Primary safety outcome: The number of adverse events, interruptions and dose     reductions in the two groups (cases and controls).      Efficacy outcomes: Efficacy outcomes are the following scores in both groups: NESSCA, SARA,     Barthel, BDI, and WHOQol.   "
247458|NCT01096108|"     Standard Quit and Win contests, in which smokers typically quit for one month in return for     the opportunity to win prizes, are simple and easy to implement and may be cost-effective in     encouraging smokers to quit. By extending contest length and enhancing counseling content,     Quit and Win contests may be more effective at encouraging smoking abstinence.      This study aims to evaluate the efficacy of extended and content-enhanced Quit and Win     contests to enhance smoking abstinence at college campuses.   "
247459|NCT01096121|"     Patients with sickle cell anaemia may develop renal disease. In fact, renal disease occurred     in 40% of adults patients (macroalbuminuria) with evolution to end-stage renal disease for     half of them. Microalbuminuria is an early and sensitive marker of glomerular damage. It     appears during the first decade and occurred in 20 to 25% of infants (2 to 18 years).     Physiopathology of renal scarring is not well understood actually. Renal scarring might be     due to glomerular hyperfiltration and vascular and endothelial damage. Angiotensin-converting     enzyme inhibitors (ACE) were studied and used in diabetic nephropathy. In a study on 26     sickle cell adults, albuminuria was reduced about 50% by ACE compared to placebo after six     months treatment. It might be interesting studying ACE efficacy in sickle cell children with     microalbuminuria because renal disease is directly related to sickle cell and is not     influenced by other cardiovascular risk factors like in adult patients.      We hypothesized to have a successful ACE treatment in more than 40% of cases after a nine     months treatment period. A success is defined as a 50% reduction of the     albuminuria/creatinuria ratio.   "
247460|NCT01096134|"     The Mother-Daughter Initiative (MDI) will test the feasibility and acceptability of a     strategy to deliver comprehensive cervical cancer prevention services in Thailand and the     Philippines by integrating the HPV vaccine for girls ages 9-13 into already successful     screening and treatment programs for mothers.   "
247472|NCT01096290|"     Constipation from medications is a serious and common condition. Lubiprostone has properties     that make it a candidate drug. One hundred volunteers with constipation who are taking     medications known to cause constipation will be randomized to take lubiprostone or placebo     for 28 days. Therapeutic outcome will be evaluated by investigator and study subject     assessment.   "
247473|NCT01096303|"     The main hypothesis is that persons that smoke or smoked tobacco and marihuana have worsen     lung function as compared with persons that only smoke or smoked tobacco.   "
247461|NCT01096147|"     Spinal cord stimulation (SCS) has been used for over 40 years to treat neuropathic pain.     Various clinical studies have shown a beneficial effect of SCS on pain in patients with     Failed Back Surgery Syndrome (FBSS). Since more than 2 years the 8-contact points Octad lead     has been used and replaced the 4-contact points Quad lead. Even though it seems that eight     electrodes has potential advantage over the four electrodes in case of lead migration or     disease progress, no clinical data have been published on the effectiveness of SCS using the     octopolar epidural lead. The Octad study intents to assess the effectiveness and technical     performance of SCS with the Octad® lead for treatment of chronic pain. This study is not set     up as a comparison study between the Octad lead and other SCS leads, such as the Quad lead,     because the Octad lead is used in most eligible FBSS patients as the standard of care lead.      The study intends to:        1. evaluate the effectiveness of SCS with the Octad® lead on chronic pain in Failed Back          Surgery Syndrome patients after 12 months of treatment.        2. collect safety data for SCS with the Octad® lead in patients with refractory chronic          pain.   "
247462|NCT01096160|"     This study will evaluate the safety and tolerability of MK8266.   "
247463|NCT01096173|"     This study is intended to be an evaluation of the properties of human sputum collected from     patients with COPD. It is hypothesized that cationic airway lining modulators will have     beneficial effects on the rheological properties of sputum derived from patients with COPD.     Approximately 10 patients with COPD will collect sputum at home for 5 days. Samples will be     collected and tested in laboratory tests.   "
247464|NCT01096186|"     The purpose of this study is to determine the long term safety and clinical utility of IPX066     in subjects with Parkinson's Disease.   "
247465|NCT01096199|"     Hypothesis: The addition of RAD001 to TS-1/CDDP is safe and can improved the efficacy of     TS-1/CDDP. The rationale for combining RAD001 with TS-1/CDDP are:        1. Potential synergism for the combination TS-1/CDDP Activation of the PI3K/AKT/mTOR          pathway is frequently a characteristic of worsening prognoses (through increased          aggressiveness), resistance to treatment, extension of disease and progression. The          antitumour effect of RAD001 is mediated through the antiproliferative and antiangiogenic          activity of mTOR inhibition. In preclinical study, RAD001 demonstrated synergism with          CDDP in several cancer types including lung (A549; CI 0.47), epidermoid cancer (KB-31;          CI 0.74), colon cancer (HCT116; CI 0.47) and gastric cancer (SNU 1; CI 0.204, SNU 216;          CI 0.546, SNU 638; CI 0.039, SNU 668; CI 0.396) (IB, Lee 2008 AACR).        2. Potential for overcoming TS-1/CDDP resistance. Upregulation of Akt pathway was found to          be an important mechanism for acquired resistance to CDDP (Lee 2005 Gyn Onc, Liu 2007          Cancer Res). In addition, gastric cancers with upregulated Akt pathway are associate          with primary resistance to 5- fluorouracil, adriamycin, mitomycin C, and cisplatin (Oki          2007 PASCO)        3. Overlapping antitumour activities with TS-1/CDDP RAD001 is effective and well tolerated          against subcutaneous tumours established from a variety of tumour cell lines of diverse          histotypes (NSCLC, pancreatic, gastric, colon, renal, melanoma, epidermoid), including a          Pgp170-overexpressing, multi-drug resistant tumor line. Partial response to single agent          RAD001 was seen in a patient with gastric cancer at the dose of 5mg/day and 2 patients          (gastric and oesophageal cancer) at the dose of 10mg/day, in study C2101 and C1101          respectively. A clinical benefit (stable disease, partial response and complete          response) was observed in 55% of patient with gastric cancer who had failed 1st line          therapy (Yamada 2009 GCS ASCO). A phase III study of RAD001 in patients with 2nd/3rd          line gastric cancer has currently opened for recruitment.   "
247466|NCT01096212|"     Sevoflurane is currently being used in more than 100 countries worldwide with an estimated     100 million operations having been performed using sevoflurane as a general anesthetic. After     the expiry of the patent on sevoflurane as a pharmaceutical drug, a generic product     (Sevofran®; Hana pharmacy, Co. Ltd, Seoul, Korea) has been launched. The aims of this study     were to investigate the efficacy (mean minimum alveolar concentration), recovery     characteristics (time to recovery of consciousness (ROC) and recovery, and BIS values at ROC     and orientation), and safety (incidence and severity of adverse events) of generic     sevoflurane in patients undergoing elective surgery.   "
247467|NCT01096225|"     The primary immunogenicity objective is to assess the antibody response and T-cell response     of split-virion inactivated A (H1N1) vaccine. Participants will include up to 20 healthy     persons of age 20 and older who have no history of novel influenza H1N1 2009 infection in     latest 3 months or novel influenza H1N1 2009 vaccination. This is a randomized study in     healthy males and non-pregnant females, aged 20 years and older. All subjects will be     stratified into 1 dose group (15mcg per dose), and will receive intramuscular influenza H1N1     vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. On Day 0, Day 10, Day 21,     Day 28, Day 35 and Day 42 after first vaccination (Day 0), the immunogenicity testing will be     manipulated. The antibody response of immunogenicity testing will be hemagglutination     inhibiting (HAI) on serum. The T-cell response will be interferon-gamma ELISPOT assay and     Tetramer staining using PBMCs.   "
247468|NCT01096238|"     In the spring of 2009, a recently emerged novel influenza A (H1N1) virus was first identified     in Mexico and USA and it has continued to spread globally. The rapid global spread of a novel     influenza A (H1N1) 2009 virus prompted the World Health Organization (WHO), on 11 June 2009,     to declare the first influenza pandemic in 41 years. In Taiwan, a clinical study to assess     the immunogenicity and safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in healthy     volunteers has already been completed. In the previous study, we found that a single 15 mcg     HA dose of the AdimFlu-S (A/H1N1) vaccine induces a protective immune response in most     adults, including those > 60 years of age (>70%). Our current study aims to follow-up     subjects who received Influenza Virus Vaccine, AdimFlu-S (A/H1N1), six months ago. These     subjects' serum samples were tested for anti-hemagglutinin (HA) antibodies by     hemagglutination inhibition (HAI). The seroconversion is defined as the post-vaccination     serum HAI titer had at least 1:40 for subjects who had seronegative pre-vaccination or a     four-fold or greater increase in HAI titers for subjects who had seropositive pre-vaccination     serum. The immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in adults after     half a year will be analyzed and discussed among the subjects with serum HAI titer had at     least 1:40 at least 3 weeks after AdimFlu-S (A/H1N1) injection.   "
247469|NCT01096251|"     The STRATOB study is a two-arm randomized controlled clinical trial (RCT). The aims of this     study are to compare the effectiveness of the BST (Brief Strategic Therapy) with the gold     standard CBT (Cognitive Behavior Therapy) in a inpatient and telephone-based outpatient     program in a sample of obese people with BED (Binge Eating Disorder) seeking treatment for     weight reduction.   "
247475|NCT01096329|"     The purpose of this study is to determine if the absorption of the testosterone spray is the     same as the Intrinsa® Patch.   "
247476|NCT01096342|"     This phase II trial is studying how well giving dinaciclib works in treating patients with     relapsed or refractory multiple myeloma. Dinaciclib may stop the growth of cancer cells by     clocking some of the enzymes needed for cell growth.   "
247478|NCT01096368|"     This randomized phase III trial is studying maintenance chemotherapy to see how well it works     compared to observation following induction chemotherapy and radiation therapy in treating     young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as     vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation     therapy that delivers a high dose of radiation directly to the tumor may kill more tumor     cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may     kill more tumor cells and allow doctors to save the part of the body where the cancer     started.   "
247479|NCT01096381|"     RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer     receiving bevacizumab may help doctors learn more about changes that occur in DNA and     identify biomarkers related to high blood pressure.      PURPOSE: This phase I trial is studying potential biomarkers for bevacizumab-induced high     blood pressure in patients with malignant solid tumors, including breast cancer, colorectal     cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, fallopian tube     cancer, or primary peritoneal carcinoma.   "
247480|NCT01096394|"     RATIONALE: Collecting and storing samples of tumor tissue and ascites fluid from patients to     test in the laboratory may help the study of cancer.      PURPOSE: This pre-clinical research study is collecting tissue samples and ascites fluid from     patients with stage III or stage IV ovarian/primary peritoneal/fallopian tube epithelial     cancer.   "
247481|NCT01098396|"     Gait disturbances are very common and are a major cause for losing of independency in     patients with advanced Parkinson's Disease (PD). The medical treatment of gait disturbances     in advanced PD is very difficult and in many cases the classical dopaminergic treatment has     no clinical benefit or even can worsen the instability and increase falls. Rasagiline, a new     MAO-B inhibitor who has recently been approved all over the world for the treatment of early     and late stages PD has been suggested to have a special effect of gait in patients with     advanced PD (LARGO sub-study).   "
247482|NCT01098409|"     The purpose of this study is to determine whether sodium nitrite administration 24 hours     prior to or during coronary artery bypass surgery protects the heart better from lack of     blood flow which occurs as part of this type of operation. The study will also determine what     the mechanisms of this cardioprotection are.   "
247483|NCT01098422|"     The purpose of this study is to determine the effectiveness of radioactive microsphere     infusion as a treatment for liver metastases from colon or rectal cancer. The investigators     hypothesis is that the administration of microspheres between first and second line     chemotherapy will increase progression-free survival time by about 2.5 months and may also     improve tumor response rates to subsequent second line chemotherapy.   "
247484|NCT01098435|"     The purpose of this study is to evaluate the safety of daily doses of RDC-0313 (ALKS 33)     compared with placebo in adults with binge-eating disorder (BED). An additional objective is     to explore the efficacy of RDC-0313 treatment in comparison with placebo in adults with     binge-eating disorder.   "
247485|NCT01098448|"     The purpose of this study is to test combined effects of scaling and root planing with     periodontal surgery, systemically administered amoxicillin and metronidazole, and/or local     tetracycline on pocket depth reduction and attachment level gain in patients with chronic     periodontitis.   "
247486|NCT01098461|"     This is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose     ranging study evaluating the dose response, efficacy and safety of subcutaneously injected     GSK716155 (albiglutide) in Japanese subjects with type 2 diabetes mellitus.   "
247487|NCT01098474|"     This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals'     candidate tuberculosis vaccine (692342) when administered concomitantly with or after the     Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and     including 2 and 7 months, living in a tuberculosis endemic region.   "
247488|NCT01098487|"     A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone     marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic     purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The     study will also describe the long-term safety and tolerability of oral eltrombopag treatment     in subjects with chronic ITP.   "
247489|NCT01098500|"     A retrospective cohort study using the LabRx medical claims database will be performed to     address these objectives. The primary objective of this project is to examine the background     rates of liver function test (LFT) abnormalities in cancer patients treated with tyrosine     kinase inhibitors (TKIs).   "
247490|NCT01098513|"     This is a single-center, randomized, two part, open-label, crossover study in healthy adult     subjects. Part A will evaluate the relative bioavailability of two new tablet formulations     compared to the current tablet formulation of GSK1349572 at 50 mg administered as single     doses each comprising of two 25 mg tablets. Pharmacokinetic samples from Part A will be     analyzed and, if at least one of the new formulations meets appropriate criteria and is     selected, Part B will be a single-sequence design conducted to evaluate food effect of the     selected new tablet formulation at one dose level. A subset of subjects enrolled in Part A     will continue in Part B. Safety evaluations and serial PK samples will be collected during     each treatment period. A follow-up visit will occur 7-28 days after the last dose of study     drug.   "
247518|NCT01098890|"     The proposed study is to evaluate the acceleration the clearance of intraventricular blood     (IVH) and subarachnoid hemorrhage (SAH) following ruptured intracranial aneurysms, thereby     ameliorating complications, such as cerebral vasospasm, hydrocephalus and intracranial     hypertension.      The primary objectives are:        1. Estimate the rate and variance of hematoma clearance following aneurysmal SAH, thereby          facilitating sample size determination for a subsequent larger study;        2. Assess the feasibility of a randomized controlled trial of intraventricular tissue          plasminogen activator (TPA) among patients with SAH (enrollment rate, ability to blind          investigators, protocol compliance);        3. Confirm the safety of intraventricular TPA.   "
250936|NCT01140243|"     The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant     formulas supplemented with different levels of LCPUFA, for premature infants following     discharge from Hospital.   "
247491|NCT01098526|"     GSK1349572 is an integrase inhibitor that is currently in Phase 2 clinical trials for the     treatment of HIV infection. As GSK1349572 development progresses, it may be dosed with     non-nucleoside HIV reverse transcriptase inhibitors (NNRTIs) including efavirenz (EFV,     Sustiva). Efavirenz is a known inducer of CYP3A4. GSK1349572 is primarily metabolized via     UGT1A1, however it also has a CYP component to its metabolism, thus a drug interaction     between GSK1349572 and EFV is likely. A previous study showed that another NNRTI, etravirine     which is also a known inducer of CYP3A and UGT, reduced GSK1349572 exposure significantly.     GSK1349572 is not an inhibitor or inducer of CYP3A and is not expected to have impact on     pharmacokinetics (PK) of EFV.      This study will investigate the dose proportionality between single doses of 50mg and 100mg     of GSK1349572 and will compare steady-state plasma PK, safety and tolerability of GSK1349572     50 mg every 24h (q24h) with and without efavirenz 600 mg q24h. Approximately 12 subjects will     receive a single dose of GSK1349572 100 mg (Treatment A) in Period 1 followed by a washout of     greater than or equal to 6 days. In Period 2 subjects will receive GSK1349572 50mg q24h for 5     days (Treatment B). Subjects will then be administered GSK1349572 50mg q24h in the morning in     combination with EFV 600 mg q24h (Treatment C) in the evening for 14 days in Period 3. There     will be no washout between Periods 2 and 3. Safety evaluations and serial PK samples for     GSK1349572 will be collected during each treatment period. A follow-up visit will occur 7-14     days after the last dose of study drug.      This study will be conducted at one center in the US, with healthy adult male and female     subjects.   "
247492|NCT01098539|"     This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a     weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired     with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately     controlled on their current regimen of diet and exercise or their antidiabetic therapy of     metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic     medications will be recruited into the study.   "
247493|NCT01098552|"     This research study is being done to collect regular and routine follow-up information     related to the outcome of treatment for prostate cancer.      This study is also being done to relate treatment outcome to measurement of substances in the     blood such as prostate-specific antigen (PSA) and other markers. Also environmental and     genetic factors that might be responsible for prostate cancer are being investigated.   "
247494|NCT01098565|"     The purpose of this study is to provide proof-of-concept that the test product can perform as     intended in an intra-operative setting and the responses to the test product are perceivable     in a person. The study will also compare results of the test product to the     commercially-available product.      Hypothesis: the test product will elicit successful test results in over 90% of test product.   "
247495|NCT01098578|"     Effectiveness of Floseal for the treatment of posterior epistaxis.   "
247496|NCT01098591|"     Numerous human cardiac stem cell studies have been published, including relatively small     number of patients. Meta-analysis of randomized trials have reported safety and a 3-6%     increase in global left ventricular performance after intracoronary stem cell therapy in     patients with acute myocardial infarction. Since most of the studies used different type of     stem cells, delivery modes, and patient population, the results are heterogenous, therefore     the comparison of the results is biased regarding generalizable conclusions about the effect     of treatment. The present comparative meta-analysis is based on individual patient data, and     gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the     cardiac stem cell therapy.   "
247497|NCT01098604|"     It has been postulated that use of a larger femoral head could reduce the risk of dislocation     after total hip arthroplasty, but only limited clinical data have been presented in third     generation alumina bearings.      The purpose of this study is to evaluate the effect of femoral head size for total hip     arthroplasty using third generation alumina bearings on the joint stability and clinical     results.      The investigators hypothesized that larger ceramic head group has a similar rate of     dislocation and clinical results in smaller ceramic head group.   "
247498|NCT01098617|"     The aim of the study is to observe the effects of antihemostatic therapy including     nonsteroidal antiinflammatory, anticoagulant and antiaggregant therapy and other patient and     procedure related factors on the risk of endoscopic biliary sphincterotomy induced bleeding.   "
247499|NCT01098630|"     This clinical trial is studying patient, physician, and nurse factors associated with entry     onto clinical trials and finishing treatment in patients with primary or recurrent uterine,     endometrial, or cervical cancer. Determining how patients make decisions about participating     in a clinical trial may help doctors plan clinical trials in which more patients are willing     to participate and are satisfied with their decision to participate.   "
247500|NCT01098643|"     RATIONALE: Gathering information about patients with solid tumors who have implantable venous     access devices may help doctors learn more about patient satisfaction.      PURPOSE: This phase I trial is studying satisfaction with placement of implantable venous     access devices in patients with solid tumors.   "
247501|NCT01098656|"     RATIONALE: Observation is watching a patient's condition but not giving treatment unless     symptoms appear or change. Lenalidomide may stop the growth of cancer cells by blocking blood     flow to the cancer. It is not yet known whether observation or lenalidomide is more effective     in treating patients who are in complete or partial response after receiving previous     gemcitabine hydrochloride or doxorubicin hydrochloride liposome for cutaneous T-cell lymphoma     or mycosis fungoides/Sézary syndrome.      PURPOSE: This randomized phase III trial is studying observation to see how well it works     compared with lenalidomide in treating patients who are in complete or partial response after     receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for stage     IIB, stage III, or stage IV cutaneous T-cell lymphoma or stage IIB, stage III, or stage IV     mycosis fungoides/Sézary syndrome.   "
247502|NCT01098669|"     RATIONALE: Collecting information about the impact of lymphedema on symptoms, functional     status, and quality of life after treatment in patients with head and neck cancer may help     doctors learn more about the disease and plan the best treatment.      PURPOSE: This phase I trial is studying the effects of secondary lymphedema on symptoms,     functional status, and quality of life after treatment in patients with head and neck cancer.   "
247503|NCT01098695|"     The investigators are testing the efficacy of a family-based preventive intervention, which     began when the children were age 2, with children at risk for developing significant conduct     problems. Families who were originally recruited from Women, Infants and Children (WIC) were     randomly assigned to a family-centered intervention developed by Dishion and colleagues     (Dishion & Kavanagh, 2003; Dishion & Stormshak, 2006) referred to as an 'ecological approach     to family intervention and treatment' (EcoFIT). The current study expands the Early Steps     intervention into the elementary school years beyond what is currently available for a WIC     service delivery venue, in which children are no longer eligible for services at age 6.      The investigators are testing the hypothesis that periodic, tailored, and adaptive     interventions delivered to caregivers at school entry will (a) reduce the probability of     elevated risk associated with early-onset problem behavior, including the eventual use of     drugs and other health-risking behaviors; (b) reduce the likelihood of mental health problems     such as childhood depression, anxiety, conduct problems and co-morbidity; and (c) promote     children's development of self-regulation, which underlies school readiness, early school     literacy academic achievement, and positive peer relations.   "
247504|NCT01098708|"     Many therapeutic trials in DMD exclude non-ambulatory boys and men. Rate of progression in     these non-ambulatory patients has been studied but consensus has not been reached for what     measures are most reliable and reproducible. Furthermore, any treatment trial would be     expected to demonstrate improved function and improvement in quality of life. Therefore,     function, strength, and quality of life must be understood and standardized. While the goal     of this proposal is to standardize clinical outcomes for therapeutic trials, careful     understanding of the progression of DMD in non ambulatory boys may also lead to better     medical treatment.   "
247505|NCT01098721|"     Psoriasis is a chronic inflammatory skin disorder that is characterized by hyperproliferation     of the keratinocytes and inflammation of the epidermal and dermal layers of the skin. This     study, in patients with mild to moderate plaque psoriasis, is designed to further determine     the efficacy, safety and tolerability of the novel, topically applied, non-steroid,     anti-inflammatory WBI-1001 cream over a period of 12 weeks.   "
247506|NCT01098734|"     Welichem Biotech has developed a small molecule drug candidate, WBI-1001, that selectively     targets the pathogenic features of inflammatory skin diseases, including atopic dermatitis (a     form of eczema).The purpose of this clinical trial is to further test the safety and efficacy     of WBI-1001 as a topically applied cream over an extended period of 12 weeks on patients with     mild to moderate atopic dermatitis.   "
247507|NCT01098747|"     This study will compare the pain relieving effect of a single-dose of a novel ibuprofen     formulation to placebo and two formulations of standard ibuprofen in the treatment of     post-surgical dental pain following wisdom tooth (third molar) removal.   "
247508|NCT01098760|"     This is a single-arm, open-label and post-authorization study to evaluate the safety and     efficacy profile of sorafenib and to evaluate Child-Pugh status progression in subjects with     advanced HCC treated with sorafenib in Taiwan.      In a subgroup of patients (hand-foot skin reaction (HFSR) study subgroup), this study also     aims to test if topical corticosteroids as preventive counter-measure applied to hands and     feet for the first 3 weeks during sorafenib treatment reduce incidence and severity of HFSR     compared to a matching, corticosteroid-free cosmetic ointment, measured over the first 3 and     6 weeks of sorafenib treatment.   "
247509|NCT01098773|"     Prospective observational clinical multicentric study in ICU with ventilated patients     requiring chest ultrasound analysis.   "
247510|NCT01098786|"     This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese     subjects.   "
247511|NCT01098799|"     The investigators are planning to study the serum level of Urotensin II in chronic kidney     disease patients, kidney transplants, and healthy controls.   "
247512|NCT01098812|"     The aims of this study are to:        -  Demonstrate a reduction in postoperative cylinder compared to results from the control          lens        -  Demonstrate better uncorrected distance visual acuity compared to the control lens   "
247513|NCT01098825|"     The purpose of this study is to explore the experiences and perceptions of District VI     pediatric clinicians on parental vaccine hesitancy and vaccine refusal.   "
247514|NCT01098838|"     The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid     tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated     dose of LCL161.   "
247515|NCT01098851|"     Patients with Obstructive Sleep Apnea (OSA) have cyclical patterns of lower blood oxygen     during sleep because of repeated episodes of upper airway obstruction that cause their     breathing to stop. When these patients have surgery, anesthetic drugs may worsen these     patterns of lower blood oxygen. This study monitors ten patients at high risk for OSA and ten     patients at low risk for OSA during surgery. Patterns of lower oxygen saturations should     arise in the high risk group but not the low risk group.   "
247516|NCT01098864|"     The main objective of this study is to examine the effects of magnetic stimulation on the     prefrontal cortex. We plan to use low frequency, repeated transcranial magnetic stimulation     (1 Hz rTMS) to temporarily inhibit activity in the prefrontal cortex and measure the     resulting effect on two decision-making tasks. The prefrontal cortex is thought to mediate or     control cognitive functions like decision-making, planning, memory, and inhibit impulsive     behavior.Previous research has indicated that rTMS over the right dorsal lateral prefrontal     cortex will lead to preferences for riskier alternatives. Our hypothesis is that rTMS over     the right DLPFC will lead to greater preference for the riskier alternative and greater     temporal discounting.   "
247517|NCT01098877|"     The study will evaluate the hypothesis that at doses and plasma concentrations which affect     pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound     is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic     profile is robust and consistent with a once or twice a day therapeutic administration.   "
247534|NCT01099098|"     We easily regard nodules and fibrosis in upper lobes of lung as TB sequelae. The aim of this     study is to confirm the prevalence of latent TB infection diagnosed by interferon-gamma     release assay and tuberculin skin tests in patients with old healed TB.   "
250963|NCT01140711|"     Aim of study:      To evaluate changes in feeding-related neural activity after different bariatric procedures     in morbidly obese patients. Relationship of gut hormone levels will be assessed as well.   "
247519|NCT01098903|"     Sunitinib is an anticancer drug, but like most drugs, the effect varies from person to     person. This is partly due to a variation in how well each person eradicates the drug from     the body. This can lead to toxicity if the drug is eliminated slowly. Just as important is     inadvertent underdosing in people who eliminate the drug quickly which may lead to a reduced     anti-cancer effect. The investigators group has developed a battery of tests that may measure     how an individual clears a drug from their body. The investigators intend to apply these     tests to a group of patients taking sunitinib to see whether any test will help predict the     level of sunitinib in the body and also the side effects. If a test seems to be promising     from this study it may be possible to do a simple test on patients before they receive     sunitinib so the best dose is chosen. The tests involve identifying the genes that are     involved with drug elimination (CYP3A, ABCB1, ABCG2, OCT1, OATP) as well as directly     measuring elimination using marker drugs (midazolam clearance and sestamibi liver clearance).   "
247520|NCT01098916|"     Aim of the study is to assess feasibility and safety of a public territorial radiology     service for home hospitalized frail elderly patients whose health conditions discourage the     transportation to hospital.   "
247521|NCT01098929|"     Congenital diaphragmatic hernia (CDH) occurs when the diaphragm, the muscle that separates     the chest cavity from the abdominal cavity, does not form properly. When an opening is     present in the diaphragm, organs that are normally found in the abdomen can move up into the     chest cavity. The primary objective of this study is to generate information about the     hereditary basis of congenital diaphragmatic hernia and abnormal lung development. Our     long-term goal is to identify ways to treat babies in utero with effective but safe drugs to     speed up lung development before birth.   "
247522|NCT01098942|"     Bone loss may occur after bariatric (weight loss) surgery, but standard methods of measuring     bone density in obese patients are potentially inaccurate. This study uses quantitative     computed tomography to examine changes in bone mineral density after bariatric surgery. We     are also studying mechanisms which may explain bone loss after bariatric surgery.   "
247523|NCT01098955|"     This is Part 1 of a 2-part research study. The goal of this part of the study is to plan and     test an investigational type of counseling called Acceptance and Commitment Therapy, for use     in patients who have or had head and neck cancer, lung cancer, breast cancer,     gastrointestinal cancer, or genitourinary cancer.      This part of the study is also designed to train the study counselors how to perform     Acceptance and Commitment Therapy.      In this part of the study, participants will either receive Acceptance and Commitment Therapy     or the standard type of counseling, called Motivational and Behavioral Counseling.      This is Part 2 of a 2-part research study. In both parts of the study, participants receive     either an investigational type of counseling (Acceptance and Commitment Therapy) or a     standard type of counseling (Motivational and Behavioral Counseling). Part 1 was also     designed to train the study counselors how to perform Acceptance and Commitment Therapy.      The goal of Part 2 is to compare Acceptance and Commitment Therapy against Motivational and     Behavioral Counseling. Researchers want to learn which type of counseling may be more     effective in helping patients to stop smoking. These types of counseling will be tested in     patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal     cancer, or genitourinary cancer.   "
247524|NCT01098968|"     EDUFIT is a group-Randomized Controlled Trial specifically designed to enhance physical     fitness and other health-related factors in a school setting in adolescents.   "
247525|NCT01098981|"     This is a randomized, placebo-controlled, phase 3 clinical trial to evaluate the efficacy and     safety of transcranial ultrasound (US) as an adjunctive therapy to tissue plasminogen     activator (tPA) treatment in subjects with acute ischemic stroke.   "
247526|NCT01098994|"     The purpose of the study is to determine whether the function of the good cholesterol (HDL     cholesterol) as well as its subfractions (via NMR spectroscopy) is altered among people with     type 1 diabetes and a variation in the Haptoglobin gene and to evaluate whether vitamin E     supplements may improve this function.   "
247527|NCT01099007|"     The overall aim of Healthy Bodies, Healthy Hearts research study is to promote physical     activity in women aged 45-65 years to promote reduced risk of cardiovascular disease. The     investigators are conducting an intervention for 12 weeks that promotes physical activity     through support groups, group exercise sessions or through information that is given at the     baseline appointment. Participants will be randomly assigned to a group.   "
247528|NCT01099020|"     The purpose of the research study is to test a measurement tool that will determine the     radiation dose people receive when they have been accidentally exposed to radiation. This     test will be done using a small amount of blood and known dose of radiation.   "
247529|NCT01099033|"     The study will examine potential biological and genetic mechanisms leading to hiatal and     paraesophageal hernia formation in predisposed individuals. It is expected that these     patients will have defects in the normal production and maturation of collagen and other     connective tissue proteins, thus leading to weakness in the diaphragm that may allow for     spontaneous herniation. Comparison of tissue and blood samples from these patients (study     group) will be made to those from individuals undergoing lower esophageal surgery who have     not developed a concurrent hernia (i.e. esophageal myotomy for achalasia and laparoscopic     gastric bypass or laparoscopic adjustable gastric banding for morbid obesity - control     group).   "
247530|NCT01099046|"     Attacks in Meniere's disease, characterized by vertigo and hearing loss, are well known to     occur repeatedly under stressed environment. Hitherto, its pathology was revealed to be inner     ear hydrops through human temporal bone studies in 1938. For the pathogenesis of inner ear     hydrops resulting in Meniere's attacks, plasma vasopressin elevation due to stress and V2     receptor overexpression in the inner ear could be essential as a basis of this disease. In     the present study, we'd like to find the effective and feasible way to reduce plasma     vasopressin level in patients with Meniere's disease.   "
247531|NCT01099059|"     Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioural disorder     of childhood. The investigators hypothesized that amantadine would be beneficial for     treatment of ADHD, and this could be evaluated in a double blind, randomized, parallel group     comparison of amantadine and ritalin.      This will be a six-week, parallel group, randomized clinical trial undertaken in an     outpatient child and adolescent clinic at Roozbeh Psychiatric Hospital in Tehran, Iran during     April 2010-May 2010.      50 male and female subjects, ages 6 to 17 years with a DSM-IV-TR diagnosis of ADHD will be     study population of this trial. At screening, investigators conduct a psychiatric evaluation     with the DSM-IV-TR criteria for ADHD and the Kiddie Schedule for Affective Disorders and     Schizophrenia-Present and Lifetime diagnostic interview and perform a complete medical     history and physical examination.      The diagnosis of ADHD will be confirmed by a child and adolescent psychiatrist before     participants will be initiated into the study. All patients will be newly diagnosed. Parents     were carefully interview and ask to rate the severity of the DSM-IV-TR ADHD symptoms that     their children display at home. Children will be excluded if they have a history or current     diagnosis of pervasive developmental disorders, schizophrenia or other psychiatric     disorders(DSM-IV axis I); any current psychiatric comorbidity that required pharmacotherapy;     any evidence of suicide risk and mental retardation (I.Q. <70). In addition, patients will be     excluded if they have a clinically significant chronic medical condition, including organic     brain disorder, seizures and, current abuse or dependence on drugs within 6 months.     Additional exclusion criteria will be hypertension, hypotension. To participate, parents and     children have to be willing to comply with all requirements of the study. After a description     of the procedures and purpose of the study, written informed consent will be obtained from     each patient's parent or guardian. Informed consent will receive before the administration of     any study procedure or dispensing of study medication in accordance with the ethical     standards of the investigative site's institutional review board and with the Helsinki     declaration of 1975, as revised in 2000. The protocol will be approved by the Institutional     Review Board (IRB) of Tehran University of Medical Sciences.      Patients will be randomized to receive amantadine or ritalin in a 1: 1 ratio using a     computer-generated code.      All study subjects will be randomly assigned to receive treatment using amantadine 100-150 mg     depending on weight (100 mg/day for <30 Kg and 150 mg/day for >30 Kg) or ritalin at a dose of     20-30 mg/day depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg) (group 2)     for a 6 week double blind, randomized clinical.      The principal measure of outcome will be the Parent and Teacher ADHD Rating Scale-IV that has     been used extensively in Iran in school-age children and provides valid measures of     behavioral abnormality and attention trial.      Side effects will be systematically recorded throughout the study and will be assessed using     a checklist that comprises 20 side effects including psychic, neurologic, autonomic and other     side effects, administered by a child psychiatrist on days 7, 21and 42.   "
247532|NCT01099072|"     Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioural disorder     of childhood. The investigators hypothesized that carnitine would be beneficial for treatment     of ADHD, and this could be evaluated in a double blind, randomized, parallel group comparison     of carnitine+methylphenidate and methylphenidate +placebo.      This will be a six-week, parallel group, randomized clinical trial undertaken in an     outpatient child and adolescent clinic at Roozbeh Psychiatric Hospital in Tehran, Iran during     April 2010-May 2010.      40 male and female subjects, ages 6 to 17 years with a Diagnostic and Statistical Manual,     Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD will be study population of this     trial. At screening, investigators conduct a psychiatric evaluation with the DSM-IV-TR     criteria for ADHD and the Kiddie Schedule for Affective Disorders and Schizophrenia-Present     and Lifetime diagnostic interview and perform a complete medical history and physical     examination.      The diagnosis of ADHD will be confirmed by a child and adolescent psychiatrist before     participants will be initiated into the study. All patients will be newly diagnosed. Parents     were carefully interview and ask to rate the severity of the DSM-IV-TR ADHD symptoms that     their children display at home. Children will be excluded if they have a history or current     diagnosis of pervasive developmental disorders, schizophrenia or other psychiatric     disorders(DSM-IV axis I); any current psychiatric comorbidity that required pharmacotherapy;     any evidence of suicide risk and mental retardation (I.Q. <70). In addition, patients will be     excluded if they have a clinically significant chronic medical condition, including organic     brain disorder, seizures and, current abuse or dependence on drugs within 6 months.     Additional exclusion criteria will be hypertension, hypotension. To participate, parents and     children have to be willing to comply with all requirements of the study. After a description     of the procedures and purpose of the study, written informed consent will be obtained from     each patient's parent or guardian. Informed consent will receive before the administration of     any study procedure or dispensing of study medication in accordance with the ethical     standards of the investigative site's institutional review board and with the Helsinki     declaration of 1975, as revised in 2000. The protocol will be approved by the Institutional     Review Board (IRB) of Tehran University of Medical Sciences.      Patients will be randomized to receive a carnitine+methylphenidate and methylphenidate     +placebo in a 1: 1 ratio using a computer-generated code.      All study subjects will be randomly assigned to receive treatment using methylphenidate at a     dose of 20-30 mg/day depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg)+     Carnitine 500-1500 mg/day (depending on weight ) or methylphenidate at a dose of 20-30 mg/day     depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg)+ Placebo for a 6 week     double blind, randomized clinical.      The principal measure of outcome will be the Parent and Teacher ADHD Rating Scale-IV that has     been used extensively in Iran in school-age children and provides valid measures of     behavioral abnormality and attention trial.      Side effects will be systematically recorded throughout the study and will be assessed using     a checklist that comprises 20 side effects including psychic, neurologic, autonomic and other     side effects, administered by a child psychiatrist on days 7, 21and 42. Side effects,     administered by a child psychiatrist on days 7, 21and 42.   "
247533|NCT01099085|"     Based on antitumor activity of statin, we designed a phase III study of capecitabine/CDDP     chemotherapy plus a low-dose simvastatin that is equivalent to cardiovascular dose in     advanced gastric cancer patients.   "
250980|NCT01140945|"     The aim of the present study is to examine the association between fertility parameters and     the periodontal status of men attending fertility and in vitro fertilization clinic.   "
247537|NCT01099137|"     Dual combination therapy with metformin and sulphonylurea is the most commonly used     combination regimen to treat patients with type 2 diabetes. But, treatment with the dual     combination therapy is often unsuccessful at achieving glycaemic control in patients with     type 2 diabetes. In this setting, use of insulin is often the next therapeutic step.      Recently, dipeptidyl peptidase (DPP)-IV inhibitor is increasingly being used in clinical     practice. It is well established that DPP-IV inhibitor improve glycemic control in patients     with type 2 diabetes.      But, there have been few studies about the glucose lowering effect of DPP-IV inhibitors     (vildagliptin) in Type 2 diabetes patients on the dual combination therapy with a     sulfonylurea agent and metformin.The researchers hypothesized that DPP-IV inhibitor as add-on     therapy to combination of a sulfonylurea agent and metformin have favorable glucose lowering     effect in type 2 diabetic patients. The researchers plan to investigate the change in HbA1C     and fasting glucose of 24 weeks treatment with vildagliptin (DPP-IV inhibitor) in combination     with a sulfonylurea agent and metformin in type 2 diabetic patients.   "
247538|NCT01099150|"     Cardiovascular disease is a major cause of mortality worldwide and responsible for one out of     three global deaths. A main characteristic of cardiovascular disease is impaired blood flow     and formation of blood clots. Platelets are clot-forming cells responsible for the prevention     of bleeding. However, in disease conditions they may be overly activated, promoting blood     clots and blockage of blood vessels.      Consumption of diets rich in fruits and vegetables decreases mortality from cardiovascular     disease through a number of mechanisms, including the prevention of platelet clotting and     aggregation. There is some evidence suggesting that platelet aggregation may be modulated     through a group of compounds known as flavan-3-ols, which are found in various foods, and     especially in cocoa. However, the mechanisms by which those compounds affect platelet     function are not yet fully understood. We designed a human study assessing the mechanisms by     which flavan-3-ols from cocoa beneficially affect platelet function and the platelet     proteome.   "
247539|NCT01099163|"     Conjugated linoleic acids (CLAs) comprise a family of linoleic acid (18:2n-6; LA) isomers     that are formed by biohydrogenation and oxidation processes in nature. The main form of CLA,     cis-9, trans-11-18:2, can be produced directly by bacterial hydrogenation in the rumen or by     delta-9 desaturation of the co-product vaccenic acid (trans-11-18:1) in most mammalian     tissues including man. The second most abundant isomer of CLA is the trans-10, cis-12-18:2     form. Observations clearly emphasize that differences exist between mammalian species in     their response to CLAs with mice being the most sensitive. The majority of studies on body     compositional effects (i.e. fat loss, lean gain), on cancer and cardiovascular disease     attenuation, on insulin sensitivity and diabetes and on immune function have been conducted     with a variety of animal models. Recent studies indicate that some but not all of the effects     observed in animals also pertain to human volunteers. Reports of detrimental effects of CLA     intake appear to be largely in mice and due mainly to the trans-10, cis-12 isomer.     Suggestions of possible deleterious effects in man due to an increase in oxidative lipid     products (isoprostanes) with trans-10, cis-12 CLA ingestion require substantiation.     Unresponsiveness to antioxidants of these non-enzymatic oxidation products casts some doubt     on their physiological relevance. We hypothesized that supplementation with CLA + an     antioxidant (vitamin E) in patients with diabetes mellitus may have beneficial effects on     glycemic control and insulin sensitivity.   "
247540|NCT01099176|"     The study is planned to show whether monotherapies or combined hypolipemic therapy influence     the fasting plasma glucose, serum adipokines (leptin, adiponectin, resistin) and     proinflammatory cytokines (interleukin-6, TNF alpha) during 30 and 90 day course.   "
247541|NCT01099189|"     Patients whose kidneys have failed need to receive dialysis treatment, most commonly with a     dialysis machine. In order to be connected to the machine an operation is often performed to     join an artery to a vein in the arm. This forms what is known as an arteriovenous fistula.     The fistula causes an increase in the flow of blood through the vein and the vein reacts to     this by becoming bigger and thicker, making it easier to connect the patient to the machine.      The success rate for the operation is relatively low and only approximately 65 from every 100     operations is still working after a year. It is thought that one factor that may cause     problems with the fistula is the ability of the vein to stretch in response to increased     blood flow. Previous research has shown that veins in kidney failure patients look different     to those of people whose kidneys are working when viewed under a microscope.      The investigators aim to study the structure of the vein that is used in making fistulas with     a microscope and also to test it in an engineering laboratory to see how much it will     stretch. The investigators hope that gaining information about the structure of the vein and     its ability to stretch will help determine what it is about the vein that affects how well it     works as part of a fistula. This information may help surgeons select the best possible vein     in a given patient to give the best chance of a working fistula in the future.   "
247542|NCT01099202|"     The goal of this clinical research study is to learn if Procrit (epoetin alfa) will decrease     the need for blood transfusions in patients with Acute Lymphocytic Leukemia (ALL),     Lymphoblastic Lymphoma (LL), or Burkitt's who are receiving chemotherapy. Another goal is to     study the remission rates in patients with cancer who have received treatment with epoetin     alfa.   "
247543|NCT01099215|"     The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic     cellular therapy, delivered as a single injection following percutaneous transluminal     (balloon) angioplasty and stent placement for the treatment of peripheral artery disease     (PAD).   "
247544|NCT01099228|"     The primary aim of this project is to determine, what fraction of individuals with     neuroendocrine tumors would show substantially improved tumor dosimetry with combined agent     therapy compared to best single agent therapy and determine the magnitude of the potential     tumor radiation dose increase.   "
247545|NCT01099241|"     Ultrasound may be useful for noninvasively determining the central venous pressure. We intend     to compare the clinical examination of the neck veins; ultrasound delineation of the internal     jugular vein; and the central venous pressure measured with an intravascular catheter.   "
247546|NCT01099254|"     The Trendelenburg position is used to distend the central veins, improving both success and     safety of vascular cannulation. The purpose of this study is to measure the cross-sectional     area of the internal jugular vein (IJV) in three different positions, using surface     ultrasound.   "
247548|NCT01099280|"     Prelabor rupture of membranes (PROM) is most commonly defined as rupture of membranes before     the onset of labor and occurs in 8% of term pregnancies. A prolonged interval from rupture of     membranes to delivery is associated with an increase in the incidence of chorioamnionitis and     neonatal sepsis. The management of the term patients with PROM, especially those with an     unfavorable cervix, remains controversial. Management options to choose from are immediate     induction of labor versus delayed induction or expectant management. Several reports have     detailed an increase in maternal and neonatal morbidity with expectant management, whereas     active management leads to a shorter interval from PROM to delivery, reducing the risk of     postnatal infections. In addition, active management is preferred by patients.      The investigators know that, neonatal intensive care admission, variable decelerations, and     primary cesarean delivery rates are positively correlated with a longer     admission-to-labor-onset interval in women with PROM . So, to reduce the induction to     delivery times, concurrent oxytocin infusion with dinoprostone vaginal pessary use for labor     induction in women with PROM may be beneficial. Several studies have shown shorter     induction-to-delivery interval with concurrent oxytocin infusion with prostaglandin agent at     initiation of labor . However, in these studies, there is a a paucity information in PROM     labor induction. Only one randomized control trial have compared the efficacy of concurrent     dinoprostone and oxytocin and oxytocin alone in women with term PROM . This study indicated     that concurrent vaginal dinoprostone and intravenous oxytocin conferred no advantage over     intravenous oxytocin alone for the outcomes of interest, including length of labor patient     satisfaction or risk for cesarean delivery. Unfortunately, this study was limited by small     sample size.      The aims of this randomized study was to compare two protocols (oxytocin vs.     sustained-release dinoprostone followed six hours later by oxytocin) for induction of labour     in women with PROM at term and an unfavorable cervix.   "
247549|NCT01099293|"     It has been observed that patients with cirrhosis present a generalized state of     vasoconstriction as an homeostatic response to splanchnic arteriolar vasodilatation. On     progression of the disease, vascular regulation is mismatched, causing altered systemic blood     flow and lose in the cerebrovascular reactivity.      The investigators hypothesize that the altered cerebrovascular reactivity induces     neurological disturbances related to hepatic encephalopathy and, therefore, the existence of     a correlation between cerebrovascular reactivity and the stage of hepatic encephalopathy.   "
247550|NCT01099306|"     This study devised an experimental focused pharmaceutical care program, allowed a clinical     pharmacist to work in a physician office to assess and manage patients' metabolic syndrome     status and its individual components. This study described the clinical benefits of     physician- clinical pharmacist interaction in achieving improved glycemic control, lipid and     blood pressure measurements, involving medication, diet, physical activity and patient heath     care counseling.   "
247551|NCT01099319|"     The purpose of this study is to assess the efficacy and safety of Renalof administration in     the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical     evaluation in elderly patients (aged >65 years). The duration of this double-blind placebo     controlled phase 3 clinical trial will be 6 months. The estimated number of patients to be     recruited and randomized for the study is 40.   "
247552|NCT01099332|"     This trial aims to test the hypothesis that 1) a single dose of zinc cysteine in a     proprietary gastro-retentive form will produce sustained blood levels of zinc giving a larger     bioavailable amount of zinc than an FDA approved preparation of inorganic zinc acetate; and     2) that the zinc cysteine gastro-retentive, sustained-release preparation will be better     tolerated with significantly less gastrointestinal side effects than the zinc acetate     capsules. The trial also tests the hypothesis that, after 6 months of once daily     administration, the zinc cysteine subjects will show reduced serum non-ceruloplasmin copper.     Additionally, subjects will perform tests of mental function,including the dementia rating     scale, the Mini Mental Status Examination and the ADAS-cognitive performance test aimed at     Alzheimer's status assessment. Tests will be administered at baseline, 3 and 6 months, and     the performance results compared. Care-giver assessments will also be noted.   "
247553|NCT01099345|"     This is an observational, pilot, non-treatment study to evaluate and develop clinical     variables for distinguishing female OAB subjects that have detrusor overactivity positive     (DO+) nocturia from female OAB subjects that have detrusor overactivity negative (DO-)     nocturia utilizing a sleep laboratory setting.   "
247554|NCT01099358|"     The primary purpose of this study is to help answer the following research question(s):        -  To see how the body absorbs, processes, and gets rid of cetuximab when the drug is taken          in combination with cisplatin [pharmacokinetic (PK) analysis]        -  To see if any drug interactions occur between cetuximab and cisplatin.   "
247555|NCT01099371|"     The purpose of this study is to determine whether:        1. Progressive resistance training improves pain and disability        2. Progressive Resistance training improves muscular strength, ability to walk and quality          of life   "
247556|NCT01099384|"     Tobacco use among adolescents is a major public health problem in the United States. The     prevalence of tobacco use among adolescents is currently highest among American Indians and     Alaska Natives. Among Alaska Natives residing in the Yukon-Kuskokwim (Y-K) Delta region of     western Alaska, approximately 29% of 11-14 year olds, and 63% of 15-18 year olds, use     tobacco. No prior work has evaluated tobacco cessation interventions for Alaska Native     adolescents.      This proposal builds on the investigators successful partnership and 7 year track record of     collaboration with the Y-K Delta Alaska Native community. The objective of this proposal is     to develop and pilot test a novel, culturally-appropriate, behavioral treatment approach for     tobacco cessation among Y-K Delta Alaska Native adolescents ages 12 to 17. The behavioral     intervention will include an initial, 2 day, group-based program with follow-up support for 6     weeks. Social cognitive (learning) theory is the conceptual basis for the proposed     intervention. The investigators expect that as a result of this stage I project, the     investigators will have developed a replicable, feasible, and acceptable intervention, the     efficacy of which can be tested in future large-scale randomized clinical trials.      This project will take place in two phases. In phase 1, the investigators will develop the     intervention with feedback from a teen advisory group, and develop a counselor manual.     Follow-up strategies will also be developed, pilot-tested, and refined. Twenty adolescents     will complete the protocol, which will be refined in an iterative manner based on feedback     from participants and counselors. Phase 2, consisting of a pilot clinical trial, will apply a     group-randomized design with assessments at weeks 0 (baseline), 6, and 26. Eight villages     will be randomized to receive either the behavioral intervention or control condition     (written self-help materials + quitline referral). Ten adolescents will be enrolled from each     village, for a total of 80 participants. The investigators will assess the feasibility and     acceptability of the intervention, as determined by qualitative ratings of treatment     acceptability, and recruitment and retention rates. The investigators will estimate the     magnitude of the effect of the intervention compared to the control condition on the     biochemically confirmed tobacco abstinence rate at weeks 6 and 26, and estimate the     intra-class correlation coefficient (ICC). At week 6, the investigators will evaluate the     effect of the intervention on changes from baseline on perceived social support,     self-efficacy for stopping tobacco use, and other mechanisms of change consistent with the     investigators theoretical framework. The overall health related objective is to develop     effective treatment programs for Alaska Native youth that will ultimately reduce their risk     of tobacco-related disease.   "
247557|NCT01099397|"     The purpose of this study is to determine if, in a subset of patients treated with a     beta-blocker and diuretic, prediabetes is detectable to a greater extent through a 2-hour     oral glucose tolerance test (OGTT) compared to fasting glucose measurement.   "
247558|NCT01099410|"     The purpose of this study is to compare the ability of two types of white blood cells to eat     dead host cells, and how this process affects their ability to protect the body from     infection. The two cell types are monocytes, a cell in the bloodstream, and alveolar     macrophages, a cell in the lung that is ultimately derived from monocytes   "
247559|NCT01099423|"     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib     malate before surgery may make the tumor smaller and reduce the amount of normal tissue that     needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that     remain after surgery. It is not yet known whether undergoing immediate surgery or surgery     after sunitinib malate is more effective in treating patients with metastatic kidney cancer.      PURPOSE: This randomized phase III trial is studying immediate surgery to see how well it     works compared with surgery after sunitinib malate in treating patients with metastatic     kidney cancer.   "
247560|NCT01099436|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide,     docetaxel, and zoledronic acid, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving more than one drug     (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination     chemotherapy is more effective when given together with zoledronic acid in treating patients     with breast cancer.      PURPOSE: This randomized phase III trial is studying giving doxorubicin hydrochloride     together with cyclophosphamide and docetaxel to see how well it works with or without     zoledronic acid in treating patients with large resectable or locally advanced breast cancer.   "
247561|NCT01099449|"     RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may     prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration     schedule of calcium gluconate and magnesium sulfate is more effective in preventing     neurotoxicity.      PURPOSE: This randomized phase III trial is studying different administration schedules of     calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in     patients with colon cancer or rectal cancer receiving oxaliplatin-based combination     chemotherapy.   "
247562|NCT01099462|"     Ibuprofen, the active ingredient in Nurofen and Advil, is a commonly used drug in children.     There is very limited data about Ibuprofen concentrations in the cerebro spinal fluid (CSF).     The objective of the current study is to describe concentrations of ibuprofen in the CSF of     infants and children after administration of ibuprofen. We will study infants presenting to     the Emergency Department (ED) with fever who received ibuprofen. A complete sepsis workup     including sampling of blood and CSF is conducted in cases of suspected meningitis. We will     measure ibuprofen in the blood and CSF obtained during the sepsis workup. A better     understanding of the pharmacokinetics of ibuprofen and its penetration into the CSF will     unable us to suggest more accurate dosing guidelines, and to better predict the effects of     this commonly used drug.   "
247563|NCT01099475|"     In order to prevent excessive blood loss during liver surgery, an intermittent Pringle     manoeuvre (IPM) can be applied. This implies a temporary clamping of the portal vein and     hepatic artery in the hepatoduodenal ligament in order to occlude hepatic inflow. The optimal     duration of the IPM is unknown. This randomized controlled trial aimed to analyse differences     in hepatocellular damage after 15 minutes or 30 minutes IPM during liver surgery for primary     or secondary liver tumours.   "
247564|NCT01099488|"     The purpose of this study is to develop immunological assays on blood samples.   "
247565|NCT01099501|"     This is a single-center, prospective, randomized, comparative, double-blind controlled     clinical study mend to assess the effect of enteral feeding with Oxepa (a fish oil-based     nutrition), compared to an isocaloric control, on oxygenation and clinical outcomes in     mechanically ventilated trauma patients.      The study population will be adults admitted to the ICU due to multiple-trauma or head trauma     as a result of a gun shut, motor vehicle accidents, fall, workplace accident etc.   "
247566|NCT01099514|"     Major response was observed to imatinib mesylate in KIT-mutated metastatic rectal melanoma     (Hodi FS et al, J Clin Oncol 26:2046-2051, 2008). In the ASCO annual meeting in 2009ar, KIT     mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas     (Heinrich MC et al, J Clin Oncol 26:2008 abstr 9016). Nilotinib is a novel tyrosine kinase     inhibitor (TKI) targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferating of both     imatinib-sensitive and imatinib-resistant cells in vitro. Phase I study of nilotinib alone     and in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal     tumors (GIST) demonstrated significant activity (72% stable disease for nilotinib alone and     56% for nilotinib/imatinib combination) (Blay JY et al, J Clin Oncol 26:2008, abstr 10553).      Thus, we propose to conduct a phase II study of nilotinib in metastatic melanoma with KIT     mutations.   "
247567|NCT01099527|"     Capecitabine is an oral fluoropyrimidine that has been shown to be effective in the treatment     of metastatic gastric and colorectal cancer patients. On the basis of capecitabine-based     chemotherapy which is accepted as a standard regimen in gastric cancer, we will perform the     phase I/II study with all-oral regimen of RAD001 with capecitabine for these refractory     gastric cancer patients.   "
247568|NCT01099540|"     To determine the response rate of pazopanib when administered as monotherapy in patients with     unresectable neuroendocrine tumor.   "
247569|NCT01099553|"     The investigators goal is to improve bowel preparations with an educational video on the     Center for Digestive Disorders (CDD) website that explains the steps required for bowel     preparation for those patients undergoing screening colonoscopies. The video will focus on     explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the     pre-colonoscopy diet, and the instructions for completing the laxative. In a randomized     fashion, patients in the control group will receive the standard written bowel preparation     instructions, while patients in the intervention group will receive standard written     instructions plus a link to watch the instructional video. The investigators hypothesize that     an educational tool that provides visual examples of a good and poor preparation, examples of     the pre-colonoscopy diet, and an explanation of how to administer the laxative will lead to     improved patient compliance and a better bowel preparation. In addition, the investigators     hypothesize that a better quality bowel preparation will improve detection of colonic polyps     and fewer recommendations for repeat colonoscopy based solely on inadequate bowel     preparation.   "
247916|NCT01102270|"     The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the     breathing effort required to briefly wake people with obstructive sleep apnea from sleep     (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the     severity of obstructive sleep apnea in some people (those that have a low respiratory arousal     threshold; i.e. wake up easily to respiratory stimuli).   "
247570|NCT01099566|"     Severe sepsis still carries a high mortality rate despite advantages in intensive care     medicine and antimicrobial therapy. The inflammatory and procoagulant host response to     infection are intricately linked and interactions between platelets, leukocytes and the     endothelium play a central role in the pathogenesis of septic shock and disseminated     intravascular coagulation (DIC). Interestingly, one key player cell in coagulation, i.e. the     platelet, has been somewhat neglected as to its position in the pathogenesis of coagulation     abnormalities in sepsis. However, thienopyridines, irreversible platelet P2Y12 ADP-receptor     antagonists, e.g. prasugrel, could potentially provide beneficial anticoagulatory and     antiinflammatory effects: P2Y12 ADP-receptor antagonists reduce TF-induced coagulation     activation in various ex vivo and in vitro models. Moreover, various lines of evidence     indicate that thienopyridines may block platelet leukocyte interactions and thereby reduce     the propagation of the coagulation and inflammation process.      LPS-infusion in healthy volunteers provides a standardized model to safely study non overt     DIC and to document possible effects of therapeutic and prophylactic interventions.      The investigators hypothesize that thienopyridines, irreversible platelet P2Y12 ADP-receptor     antagonists, may blunt TF-triggered coagulation activation in humans, which will be studied     in a TF-dependent coagulation model in humans.   "
247571|NCT01099579|"     The purpose of this study is to determine whether atazanavir powder combined with ritonavir     is safe and well tolerated and produces appropriate drug exposure in children ≥3 months to <6     years of age.   "
247572|NCT01099592|"     Depression is frequently seen in cardiac patients. It has been shown that depression often     has a negative impact on the course of coronary disease. More recently, research has     demonstrated that some antidepressants can be used safely to treat depressed coronary     patients. Although the majority of patients improve substantially with antidepressant     treatment, a significant proportion do not respond to antidepressants. This project seeks to     better understand why depression does not improve equally well in all patients. Ultimately,     the hope is to improve the treatments available to people affected by both cardiac disease     and depression, and to help select the best type of treatment in advance for each individual     based on his or her personal history, and biological characteristics.   "
247573|NCT01099605|"     Over the past decade, continuous wound infiltration systems have been introduced to treat a     variety of post-surgical pain. These systems, commonly referred to pain pumps by patients,     possess a catheter(s) attached to a reservoir of local anesthetic that directly infuses into     the surgical site to provide local pain control thus avoiding the common and less desirable     systemic effects of oral narcotic pain medication. Due to its portability, another benefit     associated with these wound infiltration systems is its use as an outpatient pain control     modality. Despite the apparent benefits, the verdict on the system's effectiveness in     treating pain - throughout a variety of surgical fields - varies between very effective in     reducing post-operative pain and reducing overall narcotic consumption for several days to     completely ineffective with no reported changes in perceived pain or overall narcotic use.      Through a randomized trial comparing plain saline to a common local anesthetic, The     investigators hope to evaluate the effectiveness of these pain pumps as an outpatient     modality for pain management following hemorrhoidectomy patients. The investigators     hypothesize that there will be a significant benefit in pain relief with the use of these     pumps.   "
247574|NCT01099618|"     The study intends on enrolling 48 subjects with diabetes. Diabetic subjects that no longer     need insulin will be randomly placed (like the flip of a coin) on a diabetes pill called     metformin, a diabetes pill called sitagliptin or a placebo pill (a pill without active     medication). Subjects on pills will be followed for 3½ years and undergo blood tests at     specified intervals to assess their ability to make insulin. These studies will allow a     better understanding of the factors that lead to high blood sugar in patients with     ketosis-prone diabetes mellitus (KPDM) and direct the best diabetes treatment for this     patient population.      Hypothesis: Metformin therapy or sitagliptin therapy compared to placebo, will improve β-cell     function, insulin sensitivity, and allow for a longer period of time prior to encountering an     insulin-deficient relapse after discontinuation of insulin therapy.   "
247575|NCT01099631|"     The working hypothesis is that oral administration of an attenuated strain of Salmonella     typhimurium is safe and efficacious for patients with unresectable hepatic metastasis from a     solid tumor cancer. The primary objective of the study is to determine the MTD of Samonella     typhimurium in the treatment.   "
247576|NCT01099644|"     The purpose of this study is to test the safety of a new medicine called antibody 8H9     injected into the lining of the abdomen or peritoneum, where the tumor is. This medicine is     an antibody or protein which binds to certain tumors, including DSCRT. There is a small     number of DSCRT which do not bind with 8H9. If the tumor does not bind with 8H9, you might     not benefit from this treatment. The investigators want to find out what effects, good and/or     bad, it has.      This antibody is made in mice. Radioactive iodine can be bound to this antibody to deliver     radiation to the tumor. The investigators wish to determine the safety of radiolabeled 8H9 at     different dose levels. This is the first study using 131I-8H9 in the peritoneum.   "
247577|NCT01099657|"     We would like to determine how well hypnosis works when induced through virtual reality     medium for patients who have suffered a major burn injury in the past two years and suffer     from chronic pain. These patients are coming back to the outpatient burn and plastic clinic     at Harborview Medical Center for routine follow-up. We think that patients will find     VR-Hypnosis interesting, and it will help them relax and feel less pain.   "
247602|NCT01099982|"     Hypothesis:      Tissue and serum samples collected from end-stage heart failure patients receiving left     ventricular assist device implantation (LVAD) or heart transplantation will provide     information regarding the basic science of heart disease. Tissue and serum samples collected     from a limited numbers of healthy controls (donor grafts that were not utilized for heart     transplantation) will serve as a comparator in research database projects.      Design:      This is a registry project; there are no investigational treatments, drug or procedures     associated with participation in registry activities. This project is an organized functional     data and tissue data gathering and storing (database) endeavor with specific focus on the     functional, structural, and molecular aspects of heart failure. Data collection will not     immediately influence the course of treatment for any patient.   "
247578|NCT01099670|"     Healthy subjects will receive NRL001 or placebo once daily for 14 days. The four treatment     groups, shown below, will each consist of 12 subjects:      Group 1; Nine subjects will receive a dose of 7.5 mg NRL001 in a 2 g suppository and three     will receive matching placebo.      Group 2; Nine subjects will receive a dose of 10 mg NRL001 in a 2 g suppository and three     will receive matching placebo.      Group 3; Nine subjects will receive a daily dose of 12.5 mg NRL001 in a 2 g suppository and     three will receive matching placebo.      Group 4; Nine subjects will receive a daily dose of 15 mg NRL001 in a 2 g suppository and     three will receive matching placebo.      The dosing of each group will be completed prior to the next group being dosed. Dose     escalation will be dependent on a positive assessment of the safety profile of the preceding     group by the Safety Monitoring Board.      The pharmacokinetics of NRL001 will be determined on Days 1, 7 and 14. Pharmacodynamics will     be examined using a three lead Holter monitor at screening and at intervals throughout the     study period. Adverse events, vital signs, ECGs and clinical laboratory parameters will be     collected, tabulated, reviewed and recorded throughout the study.   "
247579|NCT01099683|"     A total of 26 healthy elderly male and female subjects will receive both 10 mg NRL001 in a 2     g rectal suppository and placebo in this double-blind, cross-over study. The order of     treatment will be randomised, with a minimum washout period of 3 days between doses. An end     of study assessment will be conducted at least 7 days after administration of the last     treatment.      The pharmacokinetics of NRL001 will be determined prior to, and after, dosing.     Pharmacodynamics will be examined using a three lead Holter monitor during both treatment     periods. Adverse Events, vital signs, ECGs and clinical laboratory parameters will be     collected, tabulated, reviewed and recorded throughout the study.   "
247580|NCT01099696|"     This is a multicenter, double-blind, randomized, placebo-controlled, 6-week study of a     probiotic for abdominal discomfort and bloating in healthy subjects.   "
247581|NCT01099709|"     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10     mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.   "
247582|NCT01099722|"     A comparator study to assess safety and efficacy of Flutiform® compared with symbicort     turbohaler in asthma patients with moderate to severe persistent, reversible asthma.   "
247583|NCT01099735|"     This trial is enrolling patients who are already being seen at OHSU weight loss clinic or     have been referred for clinical reasons by their physician to the OHSU weight loss clinic and     are going to have a esophageal manometry that would be paid for by their insurance company     for clinical reasons.      In patients undergoing weight loss surgery investigators plan to study the effect of     continuous positive airway pressure during a esophageal manometry.   "
247584|NCT01099748|"     The objective of this study is to estimate the effect of lersivirine on the pharmacokinetics     of R-methadone and S-methadone and to investigate the safety and tolerability of lersivirine     when co-administered with methadone. Symptoms of methadone withdrawal will also be assessed.   "
247585|NCT01099761|"     The purpose of this study is to determine if ACE-031 is safe and well-tolerated in boys with     Duchenne Muscular Dystrophy (DMD) and to select the optimal doses of ACE-031 in terms of     safety and pharmacodynamic (PD) activity for designing future studies. [Note: This study was     terminated based on safety data]   "
247586|NCT01099774|"     This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B     ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12     weeks in patients with glaucoma or ocular hypertension   "
247587|NCT01099787|"     To explore the predictive value of alarm signs (red flags) for a diagnosis of functional     gastrointestinal disorders (FGID) in children.      To assess the natural history of pain predominant functional gastrointestinal disorders     (FGID) in newly diagnosed pediatric patients.      To document the benefit of various treatment regimens currently employed in managing FGID.      To assess the short- and long-term impact of various FGID regimens.      To allow physicians to gain a better understanding of the epidemiology of FGID.      Hypothesis:      There are presenting symptoms or results from diagnostic tests that are more likely to     associated with conditions different from FAP or IBS.      Symptoms of children with FAP/IBS change overtime regardless of the treatments used.   "
247588|NCT01099800|"     This interdisciplinary multi-level study moves the research in asthma health disparities from     descriptive studies of individual constructs and contexts to testing an integrated,     multi-factorial model among Latino families and children with asthma. The investigators seek     to gain a more thorough understanding of the interaction of individual characteristics,     cultural and experiential factors, social-environmental context, and healthcare system     factors on parents' illness representations, use of CAM and controller medications, and     children's asthma health outcomes.      This will be a one-year longitudinal, multi-site (Phoenix, AZ and Bronx, NY) study among     samples of Mexican (N=300) and Puerto Rican (N=300) parents and children aged 5-12 who have     asthma.      Aim #1: Are there differences in illness representations between Mexican and Puerto Rican     parents due to social and contextual factors (i.e., acculturation, education, parental age,     poverty, child's illness duration, household members with asthma, and parent-healthcare     provider relationship)?      Aim #2: Are disparities in asthma control between Mexican and Puerto Rican children due to     differences in parents' treatment decisions (CAM and controller medication use) and changes     in illness representations over a one year period after controlling for the effects of     acculturation, social and contextual factors, environmental triggers, and advice received     from others?   "
247603|NCT01099995|"     Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While     oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric     oxygen therapy (HBO) remain controversial. This study aimed at comparing two sessions of HBO     at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours     of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide     poisoning.   "
247604|NCT01100008|"     Pulmonary hypertension is a rare severe disease leading to cardiac insufficiency. Treatment     depends on the severity of the disease.      This study evaluates cardiac MRI for the assessment of pulmonary hypertension severity and     identification of parameters useful for the follow-up in order to adapt the medical treatment     to status of the patient.      Evaluate if cardiac MRI can obviate right cardiac catheterization in the follow-up.   "
247589|NCT01099813|"     This project proposes to measure delay to admission to Intensive Care (ICU). Delays in the     United Kingdom NHS are widely reported possibly because there are fewer ICU beds than in many     other developed health care systems. Patients are inevitably admitted with more severe     illness. Scores measuring this severity are used for research and benchmarking. However,     although patients deteriorate over time, severity is probably neither directly nor linearly     related to the duration of illness. Instead it is likely that the characteristics of severity     change with time. In sepsis there is good biological evidence of this so that there is an     early pro-inflammatory stage followed by later changes in metabolic, neuroendocrine, and     immune systems. In addition to examining the effect of duration of illness prior to ICU     admission, the investigators will also therefore investigate how severity changes over time.      SPOT(Light) is a prospective observational study. Treatment is not modified in anyway.     Patients evaluated on the ward by critical care outreach teams, and subsequently admitted to     critical care will be eligible. Severity of illness at the time of initial evaluation and     eventual admission will be compared, and the effect of the duration of illness on 90 day     survival investigated.   "
247590|NCT01099826|"     Colorectal cancer screening remains lower than optimal. The purpose of this study was to test     the efficacy of phone-based motivational interviewing versus tailored communication versus     usual care in increasing CRC screening in primary care clinics.   "
247591|NCT01099839|"     This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in     healthy volunteers.   "
247592|NCT01099852|"     Arbovirus is term used to refer to a group of viruses that are transmitted by blood-feeding     arthropods. The word arbovirus is an acronym (Arthropod-Borne virus). There are hundred which     have been shown to cause disease in humans. The incubation period is short usually limited     between 1 and 15 days. Among case in which symptoms do appear, the most common clinical     features of infection are 4: algo-eruptive (dengue, chikungunya, Zika virus disease...),     hemorrhagic fever (dengue, yellow fever, Crimean-Congo hemorrhagic fever), neurological (West     Nile virus disease, Zika virus disease, Japanese encephalitis.) or arthritic afflictions,     (Chikungunya, O'nyong nyong…).      Dengue is a mosquito-born viral disease caused by four different serotypes of dengue virus     (DENV). Dengue fever (DF) is defined by the sudden onset of fever associated with non     specific constitutional symptoms, recovery occurring spontaneously after three to seven days.      The infection can sometimes progress to dengue hemorrhagic fever (DHF), a disease     characterized by a transient increase in vascular permeability provoking a plasma leakage     syndrome. DHF can be complicated by shock and internal hemorrhage. Other rarer but     potentially life-threatening complications include encephalitis, hepatitis, rhabdomyolysis,     and myocarditis.      There is currently no way of predicting the outcome of DF or DHF, and the World Health     Organisation (WHO) classification lacks sufficient sensitivity and specificity to recognize     and guide the management of severe forms of dengue. The pathophysiology of these severe forms     is also poorly known, but it involves both host characteristics (immunological facilitation     in case of new infection by a different serotype, and genetic factors), and viral factors.      . Since the early 2000s, the French West Indies and French Guiana have become hyperendemic     for dengue, with simultaneous circulation of the four serotypes, regular large outbreaks, and     severe dengue including fatalities.      Chikungunya is a re-emerging alphavirus causing massive epidemics in Africa, in the Indian     Ocean, and Southeast Asia. The first autochthonous cases of chikungunya were described in     French Antilles in November 2013. The disease typically consists of an acute illness like     dengue fever, characterized by abrupt onset of a high-grade fever, followed by     constitutionals symptoms, poly-arthritis and skin involvement. Usually, the illness resolves     within à few weeks: four to six weeks. However, severe clinical forms in early stage     (encephalopathy, exacerbation of previous complaints..) may appear and chronic forms such as     incapacitating arthralgia which affect 40 to 60% of patients with confirmed chikungunya.      In France, others arboviruses may cause severe emerging and re-emerging infectious diseases     like Zika or West Nile. In non-immunized population these emerging diseases may cause     outbreaks with specific severe clinical complications from each arbovirus     (polyradiculoneuritis for Zika virus infection, encephalitis for West Nile virus infection…)      West Indies- French Guiana French interministerial mission on emerging infectious diseases,     coordinated by Professor Antoine Flahault, recommended such studies and underlined the     excellent situation of Guyana for this type of study, and as an interface for clinical and     basic research.      This epidemiological situation calls for large prospective multicenter cohort studies to     characterize severe forms of arbovirus infections, to seek predictive factors, and to     investigate the pathophysiology of the diseases .   "
247593|NCT01099865|"     The UKPDS risk score is recommended to assess global risk for future coronary heart disease     (CHD) events in primary prevention. Recently, high-sensitivity C-reactive protein (hsCRP) has     emerged as a strong independent risk factor for CHD. 18F-fluorodeoxyglucose (FDG) positron     emission tomography (PET) is a promising imaging technique for the evaluation of vascular     inflammation that reflects vulnerable atherosclerotic plaque.   "
247594|NCT01099878|"     The aim of this study is to determine whether a short-term of FES assisted cycling in stroke     patients can reduce the muscle tone of the affected leg immediately and the influence the     postural control of the subjects.   "
247595|NCT01099891|"     The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis     in patients receiving the radiation therapy or the concurrent chemo-radiotherapy   "
247596|NCT01099904|"     This open-label, parallel group study will evaluate the effect of renal function on the     pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and     assess the effect of renal impairment on safety and tolerability of RO5024048. Adult males or     females with either normal renal function or mild or moderate renal impairment will receive     RO5024048 orally for 5 days. Target sample size is <50.   "
247597|NCT01099917|"     Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York     Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of     a medicinal mushroom extract called Maitake (pronounced my-tock-e).      Laboratory studies show that Maitake can reduce the growth of cancer in animals. The Maitake     does not kill cancer cells directly. It is believed to work through the immune system (the     body's defense system against infection). Our test tube, animal and human dose determining     studies show that Maitake can enhance immune function. We are conducting this study to see     whether Maitake improves the neutrophil count and function in patients with MDS. The     neutrophils are white blood cells which help to fight infection.   "
247598|NCT01099930|"     Multiple sclerosis is an autoimmune disease. We are studying whether high dose chemotherapy     and autologous stem cell transplant can replace the autoreactive immune system and if this     reduces clinical inflammatory disease in the central nervous system (CNS). A second goal is     to examine whether there is long-term stabilization or improvement in disability scores if     the inflammatory disease is controlled.   "
247599|NCT01099943|"     Hypotheses and Specific Aims:      The continued emergence of antibiotic-resistance in the outpatient setting underlines the     need to responsibly manage antimicrobial prescribing. It is in this context that we seek to     test an effective strategy for reducing the inappropriate use of antibiotics in primary care     office practices. Our overall objective is to identify an effective and efficient strategy     for decreasing the contribution of primary care clinicians to the emergence of     antimicrobial-resistant bacteria in the community and to disseminate widely those strategies     found to be effective and sustainable.      We hypothesize that implementation of a clinician decision support system, with an active     education component, will reduce the inappropriate use of antibiotics in primary care office     practices. Our hypothesis is based on the premise that most inappropriate prescribing is the     result of multiple factors that include difficulty in distinguishing a benign, self-limited     viral infection from a more serious bacterial infection; overdiagnosis of a bacterial     infection in cases where there is clinical uncertainty as to the true nature of the illness;     and constraints on the time available for clinicians to explain to patients the nature of the     illness and the reasons an antibiotic is not indicated.      The focus of this proposal will be to compare the impact of clinical decision support and     active education to no intervention for enhancing the appropriate use of antimicrobials for     common outpatient infections. In this randomized control trial, primary care providers     participating in the intervention arm will receive active education coupled with the     implementation of a clinical decision support tool, while providers in the control arm will     have no intervention. At the end of the study, providers in the control arm will receive a     thorough analysis of their antibiotic prescribing patterns and suggested opportunities for     improvement, as well as access to the intervention tools once the study has ended.      Our interdisciplinary team will integrate novel methods in implementation science with     clinical and laboratory expertise in infectious diseases, antimicrobial stewardship, primary     care, information technology, performance improvement, health services research, and     biostatistics. The Specific Aims are constructed to validate our hypothesis in the primary     care setting by demonstrating two results of our intervention strategy:        1. Reduced use of antibiotics to treat conditions for which those drugs are known not to be          effective        2. Decreased prescribing of broad-spectrum antibiotics to treat common bacterial          infections.      The degree of impact in terms of prescriptions per 100 visits for each targeted outpatient     infection will be compared with active education and clinical decision support versus no     intervention. The study will be able to measure the value of clinical decision support with     active education that will inform future efforts in disseminating outpatient antibiotic     stewardship interventions.   "
247600|NCT01099956|"     The study propose to measure the inflammation level in type 1 diabetes children with the     cytokine analysis compared to non diabetic children of the same sibling and to healthy     children.   "
247601|NCT01099969|"     The purpose of this study is to compare the safety and efficacy of Endotrol Tube compared to     the conventional endotracheal tube in conjunction with the GlideRite stylet (Verathon Medical     Inc, USA) during videolaryngoscopy assisted endotracheal intubation using a McGrath (Aircraft     Medical Ltd., and distributed in the US by LMA North America, Inc.) video laryngoscope or a     GlideScope (Verathon Medical Inc, USA). The investigators hypothesize that using the Endotrol     tracheal tube, (Covidien, Colorado, USA) is safer and more efficacious than using the     conventional endotracheal tube during McGrath video laryngoscope and/or GlideScope aided     endotracheal intubation.   "
247605|NCT01100021|"     The purpose of this study is to see if avanafil causes any changes in blood pressure and     pulse rate when taken with doxazosin or tamsulosin.   "
247606|NCT01100034|"     Psoriasis is a chronic, often severe, autoimmune condition that affects approximately 2% of     the world's population. The epidemiology of pediatric psoriasis has not been well documented     and no treatment guidelines exist for pediatric psoriasis.      Etanercept is a biologic drug and has been licensed for the treatment of chronic severe     plaque psoriasis in children and adolescents (8-17 years of age) who are inadequately     controlled by or are intolerant to, other systemic therapies or phototherapies. Although the     long-term safety and efficacy of etanercept in children with juvenile idiopathic arthritis     (JIA) has been studied and the short-term safety profile of etanercept in both JIA and     pediatric psoriasis appears similar, there is limited data available about the long-term     effects of etanercept in pediatric psoriasis, especially with respect to malignancy. The aim     of this study is to assess the safety and effectiveness of etanercept for the treatment of     pediatric psoriasis in Europe. Patients aged 4-17 with plaque psoriasis diagnosed by a     dermatologist will be invited to participate in the registry only after a clinical decision     has been made to prescribe etanercept. The safety of the drug and how well the drug works     will be evaluated during the follow-up period. The follow-up period will last 5 years and     patients will be followed up every 3 months for the first 2 years and every 6 months for the     next 3 years.   "
247607|NCT01100047|"     This is a study in Japanese healthy volunteers to determine the safety and tolerability of     the compound, AZD5069. It will also assess how the body handles the drug and how it responds     to the drug following single and multiple doses up to 11 days.   "
247608|NCT01100060|"     Estimate the relative bioavailability of co-administered azithromycin microsphere (2000 mg)     and the chloroquine (620 mg CQ base) test formulation compared to co-administered immediate     release individual tablets of azithromycin (2000 mg) and chloroquine (600 mg CQ base) in     healthy adult subjects.   "
247609|NCT01100073|"     The study will compare the effect of pramipexole on different types of tremor and     particularly kinetic tremor in early and advanced Parkinson's disease patients and will     evaluate the course of tremor measured with spiralometry under pramipexole treatment.   "
247610|NCT01100086|"     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10     mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fasted state.   "
247611|NCT01100099|"     The investigators will evaluate the use of an HLA-DQ2-gliadin tetramer for staining of gluten     specific T cells in the diagnostics of uncertain celiac disease. Some patients have started     on a gluten free diet without a diagnosis of celiac disease. Subsequent later investigation     in special care is difficult as the patients often are reluctant to prolonged gluten     challenge. The investigators use the HLA-DQ2-gliadin tetramers for detection of gluten     specific T cells after a short gluten challenge. By this method the investigators search to     discriminate between true celiac disease and clinical gluten intolerance without celiac     disease, in a population of HLA-DQ2+ persons already on a gluten free diet without a formal     diagnosis of celiac disease.   "
247612|NCT01100112|"     Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg     Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are     not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01     (parent study [NCT00679432]).   "
247613|NCT01100125|"     It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose     levels and preserves pancreatic beta cell function in patients with type 2 diabetes. DPP-IV     inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon     secretion from pancreas by increasing incretin (GLP-1) levels. Recent studies reported that     combination therapy with DPP-IV inhibitors and other oral antidiabetic medication have     additive or synergistic effects in lowering glycose level, preserving beta-cell mass and     function as well as enhancing insulin sensitivity. However, there have been few studies about     the glucose lowering effect of DPP-IV inhibitors in patients with type 2 diabetes on insulin     treatment.      The researchers hypothesized that DPP-IV inhibitor add-on therapy to insulin treatment may     have favorable effects on glucose control and endogenous insulin secretory function in type 2     diabetic patients. The researchers plan to compare between sitagliptin (DPP-IV inhibitor)     add-on therapy and insulin dose increase therapy in uncontrolled type 2 diabetes on insulin     treatment.   "
247614|NCT01100151|"     The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in     adults with opioid-induced constipation (OIC) following repeat dose administration   "
247615|NCT01100164|"     The primary objective of the study is to determine whether eszopiclone (Eurofarma) is     non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of     insomnia.   "
247616|NCT01100177|"     Sunitinib seems to be a promising treatment for the objective of this proposal: to evaluate     the clinical activity of Sunitinib as first line therapy in patients who have measurable     disease and to evaluate the safety of Sunitinib with radiation therapy.   "
247617|NCT01100190|"     The objective of this study is to evaluate the clinical tolerability of the NUVANCE™ Facial     Rejuvenation System for correcting neck, mid-face and/or jowl ptosis.   "
247618|NCT01100203|"     Patients with Chronic Kidney Disease (CKD) have a poor prognosis primarily due to     cardiovascular disease. The cardiovascular risk can be assessed by measurements of arterial     stiffness. A decrease in stiffness has been shown to decrease the risk of cardiovascular     disease as well as death. Most of the CKD population also have hypertension and the control     of blood pressure is one of the corner stones in inhibition of disease progression. Using     drugs that specifically block the renin-angiotensin-system for blood pressure control has     been shown to have a beneficial impact on inhibition of progression beyond that of the     achieved blood pressure control. It has been reported that inhibition of the hormone     aldosterone has a positive effect on survival in patients with heart failure, hypertension     and diabetic as well as on-diabetic nephropathy.      This study undertakes the investigation of the influence on arterial stiffness of adding an     aldosterone receptor inhibitor to the medication CKD patients are already taking. Besides the     primary end point which is Pulse wave velocity (PWV), arterial stiffness is also quantified     thorough ambulatory blood pressure measurements.   "
247650|NCT01100632|"     We hope that with the drug, patients obtain reduced levels of stress and fatigue, according     to the scales that we use in the study. Hopefully the results of the treated group are     significantly higher than the control group (placebo).   "
247619|NCT01100216|"     With the advent of restrictions on public smoking, the tobacco industry has introduced a     variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These     products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than     conventional smokeless products out on the market. No studies have compared the effects of     NSTP and medicinal nicotine products (MNP) in smokeless tobacco users and whether some of the     NSTP products may serve as a cessation tool for smokeless tobacco users. Our hypothesis is     that the effects from these products will be directly related to their nicotine content and     sensory effects. Products that produce greater effects on outcome measures may serve as     potential cessation tools.   "
247620|NCT01100242|"     This is an open label, non-randomized, single arm phase II study. The primary objective of     this study is to investigate the efficacy of combination of sorafenib and VELCADE®     (bortezomib). The primary efficacy endpoint is Progression-Free Survival (PFS). The secondary     objectives of this study are to:      Assess the response rate of this combination in this patient population and Assess the     toxicity of this combination in this patient population   "
247621|NCT01100255|"     In this study investigators are studying the effects of a drug called ketamine on the     symptoms of Obsessive-compulsive disorder (OCD).   "
247622|NCT01100268|"     Available data suggest that compulsive hoarders have cognitive deficits, particularly with     sustaining attention that might contribute their hoarding symptoms.   "
247623|NCT01100281|"     The capacity of concept formation is not well understood, even if a link is supposed with the     functioning of the frontal lobes.      Our aim is to better understand the cognitive mechanisms underlying this function and to try     to correlate the performance with atrophy of the frontal lobe in neurodegenerative diseases     involving this region (frontotemporal lobar degeneration and progressive supranuclear palsy).   "
247624|NCT01100294|"     To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in     children.   "
247625|NCT01100307|"     The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham     injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular     edema.   "
247626|NCT01100320|"     To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original     OxyContin® (OXY) formulation (40 mg) in the fed state.   "
247627|NCT01100333|"     This non-interventional study (NIS) is planned to examine the consistency of the dose     recommended by the doctor for the first stimulation day with the dose recommended by the     CONSORT calculator.   "
247628|NCT01100346|"     This is a single center, prospective, observational study on the use of Gonal-f in controlled     ovarian hyperstimulation (COH) in subjects undergoing ovulation induction/ intrauterine     insemination (OI/IUI) therapy across Taiwan. It has been observed in the previous studies     that COH with follicle stimulating hormone (FSH) is considered as one of the positive     predictors of an ongoing pregnancy. Many studies in the past have tried to predict the FSH     threshold, defined as the FSH dose on the day when a follicle is >10 mm in diameter, but no     studies have been conducted to date to determine the predictive factors for a monofollicular     development after COH in IUI cycles. Monofollicular growth contributes significantly to the     reduction of multiple pregnancies and thus minimize the risks associated with such     pregnancies. This study would provide preliminary data on the factors associated with a     monofollicular development in Gonal-f treated cycles using a low dose step-up regimen.   "
247629|NCT01100359|"     RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.      PURPOSE: This phase II trial is studying how well liposome-encapsulated doxorubicin citrate     given together with carboplatin works in treating patients with advanced or metastatic     recurrent endometrial cancer.   "
247630|NCT01100372|"     RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. It is not yet known whether     liposome-encapsulated doxorubicin citrate is more effective when given together with or     without gemcitabine hydrochloride in killing tumor cells.      PURPOSE: This randomized phase II trial is studying liposome-encapsulated doxorubicin citrate     given together with gemcitabine hydrochloride to see how well it works compared with     liposome-encapsulated doxorubicin citrate alone in treating patients with ovarian epithelial     cancer, fallopian tube cancer, or primary peritoneal cavity cancer.   "
247631|NCT01100385|"     Does tomato extract improve blood vessel function in healthy people and people with     cardiovascular disease?      Atherosclerosis ('furring' of the arteries) affects the functioning of blood vessels,     narrowing and eventually blocking them, causing conditions like heart attack and stroke. The     Mediterranean diet, which is rich in tomatoes and tomato-based products, has been shown to be     associated with a reduced risk of blood vessel damage. In this double blind,     placebo-controlled randomised study, the investigators will investigate whether a food     supplement containing a standardised extract of tomato improves blood vessel function in both     healthy people (aged 40-80), and people with a history of cardiovascular disease. The food     supplement is on sale to the public, and the investigators are testing the standard dose.     Approximately 72 people will take part at the Clinical Pharmacology Unit at the ACCI     Building, Cambridge University Hospitals NHS Trust.      After they have passed screening tests, participants will be allocated by chance to receive     either the tomato extract product (Ateronon), or a matching placebo (a dummy capsule with no     active ingredients), which they will take once a day for 8 weeks. At the beginning and end of     the treatment period, the investigators will test blood vessel stiffness using an ECG machine     and external probe. The investigators will also measure forearm blood flow, which involves     infusing 3 separate agents that affect how the lining of the blood vessel wall works, and     helps to assess whether this is affected by the study treatment. Blood tests will also be     used to look at how the food supplement is working and its effects on cholesterol and markers     of inflammation. Including the screening period, and a follow-up telephone call two weeks     after the end of treatment, participants will be in the study for 14 weeks.   "
247632|NCT01100398|"     Prospective determination of the prevalence of non-alcoholic fatty liver disease (NAFLD) and     non-alcoholic steatohepatitis (NASH)in a primary care setting using ultrasound and     percutaneous liver biopsy.   "
247633|NCT01100411|"     The purpose of this study is to evaluate changes in contact lens geometry after lens wear   "
247634|NCT01100424|"     The purpose of this study was to investigate the association of inflammatory mediators found     in the tear film during the development and following the induction of contact lens     solution-induced corneal staining.   "
247635|NCT01100437|"     This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal     signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are     stabilized on EMBEDA.   "
247636|NCT01100450|"     To test the strength and physical performance outcomes of a 12-week progressive resistance     training (PRT) exercise program in a small cohort of patients with Class III obesity who are     preparing for bariatric weight loss surgery at Beth Israel Deaconess. The study will also     test patient compliance to the 12 week PRT program. Whereas PRT exercise is currently     recommended as a part of preoperative clinical care for bariatric surgery patients, little     research has been done to measure the acceptance and effectiveness of a standardized PRT     exercise protocol for improving health and perioperative care. Preliminary data from this     study could be used to justify larger studies and further investigation.   "
247637|NCT01100463|"     The purpose of this research study is to see if combining uracil ointment (1UO) with     capecitabine (Xeloda) can prevent Hand-Foot Syndrome. The study will also see what effects     1UO and capecitabine may have in patients with metastatic breast cancer.   "
247638|NCT01100476|"     The Mynx Vascular Closure Device (Mynx M5) is a sponge-like material used to close the hole     in the artery after patients undergo a diagnostic endovascular procedures   "
247639|NCT01100489|"     RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and     may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays     to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that     remain after surgery.      PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed     by radiation therapy works in treating patients with stage I or stage II breast cancer.   "
247640|NCT01100502|"     This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate     the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC)     compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following     autologous stem cell transplant (ASCT).   "
247641|NCT01100515|"     Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While     oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric     oxygen therapy (HBO) remain controversial. This study aimed at comparing one session of HBO     at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of     normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and     without coma.   "
247642|NCT01100528|"     RATIONALE: Drugs used in chemotherapy, such as dacarbazine, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving     interferon alfa-2b together with dacarbazine may be an effective treatment for primary uveal     melanoma.      PURPOSE: This phase II trial is studying how well giving dacarbazine together with     recombinant interferon alfa-2b works in treating patients with primary uveal melanoma with     genetic imbalance.   "
247643|NCT01100541|"     The objective of this work is to evaluate, from volunteers viewpoint, the usability, comfort,     appearance, weight, superficial temperature, and other characteristics of a polymeric plate     derived from castor oil developed to thermotherapy.      The volunteers will use polymeric plate as a therapeutic resource in the shoulder area and     then fill in, without interference of the researcher, some questions about the     characteristics of interest.   "
247644|NCT01100554|"     The purpose of this study is to evaluate the upper airway collapsibility by sleep endoscopy     in different sedative levels. Propofol pump infusion will be used to achieve conscious     sedation. Bispectral Index monitor will be applied to the monitor the conscious level. Two     different sedative levels (BIS 65-75, 50-60) will be achieved for upper airway evaluation.     The severities of upper airway obstruction will be evaluated the correlation to the disease     severities. Mandible advancement will be done to evaluate the response for oral appliance.   "
247645|NCT01100567|"     This study will evaluate the effects of a novel, non-pharmacologic intervention for the     prevention of deleterious changes in bone density and strength in adolescents with anorexia     nervosa (AN), a disease commonly treated with extended periods of bed rest and     immobilization. The primary focus of the trial is to conduct a prospective short-term     intervention to prevent an uncoupling of bone turnover in inpatients hospitalized for AN, and     to determine the long-term effects of a biomechanical intervention on skeletal health in     ambulatory adolescents with AN.   "
247646|NCT01100580|"     Nephrolithiasis is a disease that strikes roughly 10% of the Italian population and its     incidence in industrialized countries is on the increase. The most common form of the disease     (80%) is Idiopathic Calcium Nephrolithiasis (ICN) with calcium-oxalate (CaOx) and/or     calcium-phosphate (CaP) stones. The etiopathogenesis involves both genetic and acquired     factors, the interplay of which leads to urinary biochemical anomalies at the root of stone     formation. The elements and urinary compounds involved are known as urinary stone risk     factors. The risk factors for CaOx stones consist of low urine volume, hypercalciuria,     hyperoxaluria, hyperuricosuria, hypocitraturia and hypomagnesuria. In the case of CaP stones,     the hyperphosphaturia and pH parameters are of particular importance; a pH>7 promotes the     formation of stones prevalently composed of phosphates, while a pH of between 6 and 7,     associated with a volume <1l/day, can raise CaP supersaturation to a dangerously high level     and lead to the formation of mixed CaOx and CaP stones. For uric acid stones, the elements     involved are hyperuricosuria and pH<5.5. In general, the most prevalent alteration in ICN is     hypercalciuria (50%). Hypertension and obesity are also social diseases with important     epidemiological similarities to nephrolithiasis. These affinities have led to the search for     a common pathogenic moment. As far as hypertension is concerned, various studies have     demonstrated high calciuria in hypertensives with a linear relationship between 24-h     calciuria and arterial blood pressure. The incidence of stone disease is greater in     hypertensives than in normotensives and, by the same token, the incidence of hypertension is     greater in stone formers than in non stone formers, but it is not clear whether     nephrolithiasis is a risk factor for hypertension or vice versa. Moreover, a linear     relationship exists between calciuria and natriuria, where the calcium is the dependent     variable, with a much steeper slope of the straight line in stone formers and hypertensives     compared to controls. It has, in fact, been demonstrated that to reduce calcium, it is more     efficacious to reduce sodium intake as opposed to calcium intake. Finally, BMI and body     weight are independently associated with an increase in stone risk even though, due to a     number of bias (limited weight categories, low number of obese persons in the study     populations, no control group, no recording of food intake) the studies published failed to     be conclusive. In the final analysis, stone disease, arterial hypertension and excess     weight/obesity prove to be closely interconnected and it is possible to intervene with     targeted diets aimed at reducing the risk of illness and death from these diseases. Among     such dietary approaches, the reduction of sodium chloride in food, increased hydration and an     increased intake of foods with an alkaline potential seem to play an important role.      For many years now, the investigators research unit has been involved in projects, partially     financed by the Italian Ministry of University and Research (MIUR), geared towards studying     the effects induced by dietary changes in patients with calcium stone disease. The aim of the     present project is to analyse in depth the relationship between stone disease, hypertension,     body weight and water and salt intake both in the general population of the area of Parma     (where historically and by gastronomic tradition, the usual diet tends to have a high salt     content) and in a selected population of stone formers and hypertensives not under treatment.     A representative sample of the population of the area of Parma will be studied, divided on     the basis of weight category, in order to assess water and salt intake and relationships with     the presence of hypertension, and a sample of normal and hypertensive stone formers     randomized to receive for one year either water therapy+low salt diet or water therapy alone.   "
247647|NCT01100593|"     The purpose of this study is to compare catheter length and extravasation rates for     Ultrasound (US)-guided peripheral intravenous (IV) catheter insertion in a subset of     emergency department patients with difficult IV access. Physicians, Emergency RNs, and     Emergency Technicians can be taught to use US guidance to start peripheral IV in the ED. The     optimal length of catheter to use for this procedure is unknown. This study will provide data     on the length of catheter required to minimize extravasation. There is no guideline on     catheter length selection for US-guided peripheral vascular access. This study may decrease     extravasation rates for US-guided peripheral vascular access by providing guidance on     catheter length selection.   "
247648|NCT01100606|"     A study to determine the safety, effectiveness, and acceptability of 2 methods of     administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000     lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic     insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma     (formerly Eurand).   "
247649|NCT01100619|"     The primary objective of this clinical study is to determine whether the inhibition of     cytochrome P450 (CYP) isozyme CYP2C8 by XL184 observed in in vitro preclinical studies     translates into the potential for clinically significant drug-drug interactions in humans.     The study will measure the effect of once daily dosing of XL184 on the pharmacokinetics (PK)     of rosiglitazone. The PK of XL184 when combined with rosiglitazone will be evaluated as well.      A specific objective of this study is to determine whether the interaction between XL184 and     a drug such as rosiglitazone is sufficiently large enough to necessitate a dosage adjustment     when used in combination with XL184, or whether the interaction would require additional     therapeutic monitoring.      Rosiglitazone, commonly known as Avandia, is a prescription medicine approved by the FDA used     to treat adults with Type 2 (adult-onset or non-insulin dependent) diabetes mellitus (high     blood sugar). In this study, subjects will only take 2 doses of rosiglitazone. There is no     intention of therapy as a result of taking rosiglitazone in this study.   "
247652|NCT01100658|"     While neurocognitive impairments in attention, memory and executive functioning are commonly     reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to     examine the treatment of attention deficits in this population. Numerous studies have     examined the effectiveness of methylphenidate in the treatment of children with attention     deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for     improving attention and behavioral functioning in children with medical illnesses or brain     injury are less clear.      Patients will be randomized to receive one week of Metadate CD (a controlled release form of     methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.   "
247653|NCT01100671|"     Vascular inflammation is a key factor in both the pathogenesis and outcome of     atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a     promising tool for identifying and quantifying vascular inflammation within atherosclerotic     plaques.cardiac multidetector-row CT can provide measurements of coronary artery calcium     (CAC), the degree of stenosis, and the characteristics of plaque including its potential     vulnerability. Therefore, the purpose of the investigators study is to compare the usefulness     of 18 FDG-PET and MDCT in assessing the vascular inflammatory status and vulnerability.   "
247654|NCT01100684|"     The purpose of this study is to determine whether asimadoline is safe and effective at     treating D-IBS.   "
247655|NCT01100697|"     Neural tube defects are one of the most prevalent congenital abnormalities, surpassed only by     cardiac malformations. Spina bifida accounts for the majority of the neural tube defects and     is comprised of a wide spectrum of anomalies ranging from small isolated sacral dysraphisms     to large spinal defects. The origin of spina bifida is a failure of neurulation. It usually     occurs at 15 days post-conception, resulting in a bony spinal defect with extrusion of the     neural placode and/or the meninges outside of the spinal canal. Spina bifida has a prevalence     of 1-5 in 1,000 live births and is the most complex congenital abnormality compatible to     long-time survival. Concerning psychomotor development as well as urinary bladder and     intestinal morbidity the prognosis ranges from normal functional outcome to severe     disability.      The diagnosis of serious fetal abnormalities such as spinal dysraphism by ultrasound     screening allows patients to prepare for the birth of an impaired child or to consider     termination of the pregnancy. In current practice, prenatal counseling and obstetric     management depend not only on the detection of a spinal dysraphism but also on an appropriate     assessment of the severity of the defect and its possible impact on the postnatal development     of the affected child.      Level and type of lesion, presence of associated anomalies (e.g., Chiari II malformation and     ventriculomegaly) and mode of surgical closure are factors known to have prognostic impact on     the postnatal outcome. Previous studies reported that postnatally determined lesion levels     correlated well with functional status and survival. On the contrary, it is still not clear     whether similar data obtained antenatally are of value.      In this study, the investigators will review their database of all cases of prenatally     diagnosed spina bifida within a 16 year period between 1993 and 2009. By analyzing the     prenatal and postnatal characteristics of fetuses with spina bifida in relation to the     anatomic level of the lesion, the investigators aim to contribute further information     regarding the natural course of affected pregnancies and the correlation of prenatal     ultrasound findings with their functional outcome.   "
247656|NCT01100710|"     The purpose of this study is to determine the influence of functional or anatomic cardiac     parameters, age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals.   "
247657|NCT01100723|"     This trial is designed to determine if the use of a computer algorithm designed to optimize     mineral outcomes in dialysis patients increases the number of patients achieving the desired     target endpoints for calcium, phosphorus and parathyroid hormone.   "
247658|NCT01100736|"     Endothelin-1 (ET-1) has been linked to a number of conditions including pulmonary arterial     hypertension (PAH). ET-1 acts via 2 receptors, ETA and ETB. The ET-1 receptor blockers     bosentan and sitaxsentan have been shown to be beneficial in patients with PAH. Bosentan     blocks both ETA and ETB receptors. Sitaxsentan selectively blocks ETA receptors.     Theoretically, selective ETA blockade may be associated with greater vasodilation and     clearance of ET-1 by leaving the ETB receptor unblocked. This has not been directly studied     in humans.      We aim to investigate the endothelial ETB-mediated vascular responses between bosentan and     sitaxsentan by using a ETB selective agonist (ET-3). We hypothesise that at clinically     relevant doses:        -  Bosentan will show evidence of ETB receptor blockade compared to sitaxsentan and          placebo.        -  These effects will be confirmed by 2 functional markers of ETB receptor antagonism:          plasma ET-1 (a very sensitive, but not necessarily clinically relevant marker), and the          forearm vasodilator response to ET-3.   "
247659|NCT01100749|"     Hepatitis C is a small RNA virus spread by blood to blood contamination. There are to date 6     known genotypes and within each there are several subtypes. Although all genotypes are     distributed worldwide some are more common in certain countries and/or among certain     populations.   "
247660|NCT01100762|"     The use of low level electrical stimulation when applied over the head, also called     transcranial direct current stimulation (tDCS), is being tested by several groups of     researchers to see if tDCS can improve movements of persons with damage to the brain. The     safety and potential benefits of tDCS to children or adults patients who are paralyzed     because of brain damage are reported in the medical literature. In addition, some patients     with Parkinson's disease (PD) experience improvement in memory and report better use of the     hand after tDCS. The treatment requires putting electrodes (pads) over the head and sending     very small amount of electrical current that the patient may feel as little tingling.     Application of tDCS takes 20 min. In this study we wish to test if tDCS application can     improve stepping and walking ability of subjects with PD and if the improvement is the same     as when walking on treadmill. We plan to test the subject's ability to step when pulled by a     laboratory testing system and also test his/her walking ability. There will be 3 sessions 7     days apart. In the first session the subject will be tested then treated for 20 min with tDCS     and then tested again. In the second session the subject will be tested then walk on a     treadmill for 20 min then tested again. In the third session the subject will be tested then     walk on the treadmill for 20 min while receiving also tDCS and tested one last time at the     end of the session. Each session will take between 2 and 3 hours.   "
247917|NCT01102283|"     The objective of this registry is to compile clinical data on the use of the Evolution®     Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused     by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in     patients with malignant strictures.   "
247672|NCT01091454|"     This phase II trial studies how well brostallicin and cisplatin work in treating patients     with breast cancer that has spread to other parts of the body (metastatic) and does not have     estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor     receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as     brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from spreading.   "
247661|NCT01100775|"     Schizophrenia is a chronic disorder with onset of psychosis occurring in late teen early     twenties, with cognitive impairments and negative symptoms frequently emerging much earlier.     Such cognitive impairments and negative symptoms but much milder are also observed in     high-risk groups (such as relatives of schizophrenia patients), who may or may not develop     the full blown psychotic disorder. Our study plans to recruit such non-ill subjects to test     the effects of galantamine on clinical/physiological/cognitive measures. This study serves     several goals: If a drug is found effective in treating subtle deficits, then it will provide     treatment strategy in individuals with schizophrenia spectrum personality disorders and for     early intervention in schizophrenia. In addition, one of the difficulties of testing a drug     on schizophrenia is that patients take other medications (i.e., antipsychotic drugs) that can     change the effects of the test drug. The proposed study will be in subjects who will not be     taking antipsychotic medications. Our study will be carried out in two sessions, at least one     month apart. Subjects will be randomly assigned to the two possible order of administration:     the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3     days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th     day, the day of testing. We will administer a battery of     clinical/cognitive/neurophysiological tests after the 8 mg drug dose.   "
247662|NCT01100788|"     Populations that report high fiber consumption demonstrate lower rates of obesity. Enhanced     satiety may play a key role in this relationship. The colonic fermentation of fibers is     theorized to influence satiety and food intake. Short chain fructooligosaccharide (scFOS) are     rapidly fermentable fibers that can easily be added to foods to impact these parameters.      The objective of this study was to evaluate the satiety response of scFOS and its ability to     decrease food intake.   "
247663|NCT01100801|"     This is an open, non-randomized, multicenter Phase II study evaluating cisplatin plus TS-1 or     oxaliplatin plus TS-1 as first-line therapy in predicted 'responder' to platinum and     fluoropyrimidine.      This study is planned in 3 centers in Singapore and Korea. A total of 30 subjects will be     enrolled into each treatment arms. Each centers will recruit 15-25 subjects predicted to be     'responder' to platinum and fluoropyrimidine. The study will consist of a prescreening     period, a screening period and a treatment period. A fresh tumour biopsy sample will be     obtained during the prescreening period for gene expression profiling.      As this is a genomics guided trial, obtaining tissue biopsies is vital to the conduct of the     trial.      Patients will have the primary in situ (requirement for entry into trial), endoscopic biopsy     performed prior to 1st cycle.   "
247664|NCT01100814|"     The investigators hypothesize that aberrant hypermethylation of tumour suppressor genes is an     important mechanism for Epstein-Barr Virus (EBV) - related gastric carcinogenesis, the     promoter hypermethylation status and the expression of S100A2 and TFF1 might be different     between EBV-associated gastric cancer (GC) and non EBV-associated GC.   "
247665|NCT01100827|"     To determine EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC.      To determine the association between EGFR mutation status and demographic data in advanced     stage adenocarcinoma NSCLC patients.   "
247666|NCT01100840|"     The purpose of this study is:        1. To characterize the types and frequency of molecular alterations to the epidermal growth          factor receptor (EGFR) pathway, FGFR4 and EML-ALK in Asian patients with non-small cell          lung cancer        2. To identify candidate biomarkers of importance in the EGFR and estrogen pathways      Most, if not all, human malignancies including lung cancer are caused by somatic alterations     of the genome, leading to activation of oncogenes or inactivation of tumor suppressor genes     and their resultant oncogenic effects. In addition to mutations, increased chromosomal copy     number (by amplification or polysomy) and DNA methylation are other mechanisms of oncogene     activation and tumour suppressor gene inactivation respectively.      Little is known about the relationship between these oncogenes of the EGFR family and the     recently described oncogenes FGFR4 and fusion gene EML4-ALK. Recent data suggests molecularly     defined subgroups of non-small cell lung cancer (NSCLC) exist and can be used to predict for     sensitivity to targeted agents (erlotinib or gefitinib) or cytotoxic chemotherapy     (pemetrexate, gemcitabine, platinum agents). The findings that estrogen receptors are present     in lung tumours and that estrogen can stimulate growth and proliferation of lung cancers in     vitro and in vivo are provocative. Further studies to evaluate the role of estrogens and     other sex hormones in lung cancer are warranted.      A further understanding of the molecular indicators of lung cancer prognosis and treatment     prediction would improve drug development and patient treatment selection.      Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the     Department of Pathology and the National University Tissue Repository respectively.     Clinico-pathological characteristics will be obtained from the case records, Pathology and     Tissue Repository. DNA will be isolated using standard techniques. Sequencing of genes in the     EGFR signaling pathway: EGFR, KRAS, ErbB2, ErbB3, MET, PI3K, and BRAF as well as FGFR4.     Unstained slides from the paraffin-embedded tissue will be obtained and subjected to     fluoresce in vitro hybridization (FISH) for breakpoints in the EML4 and ALK genes as     previously described. For cases that have been snap-frozen, RNA will be extracted and     EML4-ALK fusions will be confirmed using RT-PCR and pre-specified primers. To analyse the     expression of proteins of putative relevance to EGFR function (such as EGFR, ErbB2, ErbB3,     AKT, MET, STAT, ERK, MAPK, cyclin D1, C/EBPa), downstream effects of EGFR: cell proliferation     (Ki-67), angiogenesis (CD34, VEGF-A), apoptosis (bcl-2), metastasis, and hormonal influence     (oestrogen and progesterone receptors, aromatase), TMA technology will be utilised. The     status of the tumor suppressor genes PTEN and C/EBPa will be analysed.   "
247667|NCT01100853|"     Until positive results were found with oral naltrexone, no medication has been effective     against amphetamine dependence. The primary aim of this pilot study is to replicate the     findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine     addiction and to extend their results by randomizing treatment-seeking amphetamine addicted     patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable     suspension) or VIVITROL placebo. Patients in each group will receive drug counseling.     VIVITROL is administered monthly and may be a better test of efficacy than tablets that must     be taken daily.   "
247668|NCT01100866|"     This is a randomized, two-arm, placebo controlled trial to evaluate benefit of treatment     using POMELLA™ extract on mechanisms known to drive prostate cancer. This research allows     provision for biochemical and histological comparisons to be made between POMELLA™ treated     and placebo treated prostate tissues removed from men with organ confined prostate cancer.   "
247669|NCT01100879|"     Anaemia and functional iron deficiency are common conditions in Multiple Myeloma (MM)     patients, conditions which reduce significantly the quality of life and increase morbidity     and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been used, but     recently their use has been shown to have a negative impact on overall survival in different     oncology populations. Recently published data suggest that intravenous (IV) iron can be     effective in anaemia treatment, even without ESAs. This exploratory study is the first     clinical project with ferric carboxymaltose (FCM) in patients with MM: the data generated may     be used for further evaluations of the drug in larger populations. In this study, 1,000 mg of     IV iron as FCM will be administered on the same day or within 24 hours before or after     chemotherapy treatment. The primary objective is to evaluate the efficacy of FCM given     without ESA, in the correction of haemoglobin levels in subjects with MM, undergoing     chemotherapy. Secondary objectives aim to describe the safety and tolerability of FCM, and     the effect of FCM treatment on iron status variables in MM subjects.   "
247670|NCT01091428|"     This is an open-label, multicenter study with a nonrandomized Phase 1 portion and an     open-label, randomized, Phase 2 portion evaluating MLN8237 in combination with weekly     paclitaxel in adult female patients with advanced breast cancer (Phase 1 portion only) and     recurrent ovarian cancer (both Phase 1 and Phase 2 portions).   "
247671|NCT01091441|"     The observatory consists of a row of data collection on a population composed of all patients     with heart failure cared for in centers participating in the national education program for     patients (named I-CARE) in the form of two groups. Patients who are undergoing a program of     therapeutic education track are listed and included in the group of patients educated.     Patients who receive no education or only a minimal element for any reason whatsoever are     also listed and included in the group of patients who are not educated.      The following of patients will be periodic after their entry in the observatory, up to 2     years of follow up.   "
247918|NCT01102296|"     Male homosexuals are at risk for hepatitis A virus (HAV) infection, and HAV vaccination has     been recommended to prevent HAV infection in male homosexuals. HIV infection may impair     serological responses to HAV vaccination in HIV-infected patients. The investigators     hypothesize that 3 doses of HAV vaccine will improve serological responses to HAV vaccine in     HIV-infected patients.   "
247674|NCT01091480|"     Hypertrophic cardiomyopathy (Hypertrophic CardioMyopathy=HCM) remains a poorly understood     disease with an assumption insufficiently codified. There is no data available in France on     the profile of patients, diagnostic methods and assessment and therapeutic use.      The purpose of this study is to establish a monitoring of patients with HCM (sarcomere of     origin or not) in France (diagnosis, treatment)   "
247675|NCT01091493|"     COPD is one of the most important causes of morbidity and mortality and supposes a sanitary     problem in Europe and USA. Patients with COPD usually have 1-2 episodes of acute exacerbation     of COPD (AECOPD) per year, being these the principal causes of of hospitalizations,     respiratory problems and medical visits. After an episode of AECOPD, the majority of patients     develop a transitory (or permanent) worsening in their quality of life and 50% of them will     require a new hospitalization. Globally, a 75%& of the exacerbations might be associated with     a respiratory tract infection, and among them, 50% might be related to bacteria and in 45% an     evidence of viral infection could be documented. Even though the antibiotic treatment might     not be useful for a majority of patients with AECOPD, is generalized its use(almost an 85% in     some series) in hospitalized patients. The non-controlled use of antibiotics in AECOPD     results in a very expensive disease and raises the rate of resistance of bacteria. The     available literature have shown that there's a relation between exacerbations and infections,     based on sputum samples.      In summary, is well known that at least a 50% of the episodes of AECOPD might be associated     with pathogenic bacteria in the lower respiratory tract. Prescription of antibiotics is wide     and generalized in hospitalized patients. Clinical trials have shown correlation between     AECOPD with sputum purulence (which correlates with presence of bacteria), however they've     not included NON-purulent AECOPD, even though they're a significative group of patients     hospitalized by this cause too. It's necessary to evaluate the efficacy nor the security of     antibiotic treatment in this group of patients in a well designed trial.   "
247676|NCT01091506|"     This study is a 12-week, double-blind, placebo-controlled trial of L-methylfolate 15 mg/d     supplementation in schizophrenia patients with mild or greater negative symptoms.     L-methylfolate, a prescription medical food, is the activated form of folate required for     conversion of homocysteine to methionine and hence is the optimal form of folate for     supplementation, since it eliminates the need for activation by MTHFR. The purpose of this     study is to examine the change in plasma L-methylfolate concentrations following a     three-month trial of L-methylfolate 15 mg/d compared to placebo.   "
247677|NCT01091519|"     Collect information on treatment with Toviaz (fesoterodine) under ordinary prescribing     conditions, and to investigate whether additional educational information affects     satisfaction with treatment as perceived by the patient.   "
247678|NCT01091532|"     The purpose of this study in healthy people is to investigate the safety, toleration and time     course of UK-396,082 concentration in the blood and any changes in relevant markers of drug     effects, following multiple doses given twice daily by mouth for 14 days.   "
247679|NCT01091545|"     To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM)     regarding effectiveness as screening modalities.   "
247680|NCT01091558|"     The purpose of this study is to look at the importance of L-Arginine in the digestive tract.     L-Arginine is an amino acid and is important in making proteins within the cell.      The evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us     learn more about L-Arginine and ulcerative colitis. The investigators believe these studies     will provide new insights into the treatment for Inflammatory Bowel Disease (ulcerative     colitis) and nutritional needs. The investigators plan to enroll 200 participants in this     study over the next two years.   "
247681|NCT01091571|"     During sepsis and septic shock the immune response can be overwhelming leading to excessive     tissue damage, organ failure and death. Ideally, the inflammatory response is modulated     leading to both adequate protection to invading pathogens as well as limitation of an     exuberant immune response. In the last few years adenosine is proposed to have a central role     in the modulation of inflammation. In unfavorable conditions such as hypoxia, ischemia or     inflammation adenosine is quickly up-regulated; with concentrations up to tenfold in septic     patients. Many animal studies have shown that adenosine is able to attenuate the inflammatory     response and decrease mortality rates. Therefore, pharmacological elevation of the adenosine     concentration is an potential target to attenuate inflammation and limit organ injury.     Dipyridamole, an adenosine re-uptake inhibitor is able to increase the adenosine     concentration and limit ischemia-reperfusion injury. In order to study the effects of     dipyridamole on the inflammatory response we aim to use the so called human endotoxemia     model. This model permits elucidation of key players in the immune response to a gram     negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel     therapeutic strategies in a standardized setting.   "
247690|NCT01091688|"     We, the investigators, will provide Just-in-Time information, physician educational     material, to primary care pediatricians of Neonatal Intensive Care Unit (NICU) graduates at     the time of NICU discharge. We will follow the rate of adverse events (deaths,     re-hospitalizations, emergency room visits, and missed appointments) for 6 months after NICU     discharge. We will assess levels of physician comfort in caring for NICU specific diseases,     as well as physician satisfaction with the discharge process. We hypothesize that the     provision of Just-in-Time information will decrease the rate of adverse events, and make     physicians more comfortable in caring for complicated NICU graduates, and more satisfied with     the discharge process.   "
247919|NCT01102309|"     The goal of this study is to determine if robot aided rehabilitation therapy can be     equivalent to or more effective than conventional rehabilitation therapy at promoting     functional recovery of the paretic upper limb in acute and subacute stroke patients.   "
247691|NCT01091701|"     This study will evaluate the safety and efficacy of intravenous ex vivo cultured adult     allogenic mesenchymal stem cells in patients with ischemic cerebral stroke. Patient will be     given single intravenous dose of allogenic mesenchymal stem cells 2 million cells/Kg body     weight or placebo within 10 days of stroke. Patients will be followed up till 12 months.     Safety will be evaluated by type, number and proportion of patients with adverse events.     Efficacy will be evaluated by clinical parameters and MRI.   "
247692|NCT01091714|"     To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective     levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending     on a specific product utilized within this study.   "
247682|NCT01091584|"     The use of interventions for cancer-related distress is important to reduce this distress.     Distress has a negative impact on quality of life, the recovery during and after treatment     and may even adversely affect survival. There is insufficient attention to the systematic     approach to psychosocial problems in cancer patients in the Netherlands. A task force     discussed and studied which instrument measures psychosocial problems best. The distress     thermometer (lastmeter) had the best results. A guideline is written to use the distress     thermometer for patients with cancer and will be used in hospitals in the Netherlands.     However, it is not clear what the effects are of the use of the distress thermometer on the     psychosocial wellbeing of the patient. Furthermore, it is also unknown whether the use of the     distress thermometer leads to cost-effective care. The study focuses on the use of the     distress thermometer in breast cancer patients. An efficiency study (RCT) will be conducted     to evaluate the systematic use of the distress thermometer and its discussion by a nurse as     compared to the usual care provided to outpatients who are treated with curative intent for     breast cancer by their treating physicians. The clinical and economic impact of the use of     the Distress thermometer will be assessed in comparison with usual care.The recruitment of     patients will take place in the out-patient clinic of a university hospital. Patients will be     followed from diagnose until two years after finishing their treatment.   "
247683|NCT01091597|"     Curative catheter ablation has been established as an effective therapeutic option for atrial     fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However,     standard ablative approaches targeting the pulmonary veins (PVs) are associated with a     success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of     catheter ablation of AF isolating the posterior left atrium including all PVs (called Box     Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6     months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs,     with a single procedure success rate of 87% (40/46). This study provided new evidence     supporting the hypothesis that the posterior wall is of high importance for the maintenance     of AF. The aim of the investigators study is to determine the efficacy of two different     approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment     of chronic AF.   "
247684|NCT01091610|"     Ambulance personnel often work in a dangerous environment and work related injuries of     emergency medical staff have repeatedly been documented. However, only case reports are     published and no data exist about the incidence and type of work related injuries of     ambulance personnel.      Aims:      The primary aim of the study is to assess the incidence (number of new injuries per 100'000     emergency missions or per 1'000 flying hours) and type of work related injuries among     prehospital emergency personal. The secondary aims are to identify risk factors associated     with work related injuries and to compare the risk of injury to other groups of professionals     such as hospital nurses, policemen or fire-fighters.   "
247685|NCT01091623|"     Background. Exercise intolerance is one of the most devastating consequences of chronic     obstructive pulmonary disease (COPD). Abnormalities in peripheral muscle function such as     weakness and reduction in oxidative enzyme activities are commonly found in these patients     and may contribute to exercise intolerance.To evaluate whether a systemic weightlifting     exercise may improve exercise capacity better than endurance training, or a combined training     is more effective, the investigators compared three different training regimens, endurance     training alone, systemic weightlifting training alone or a combination of both endurance and     weightlifting training.      Methods.36 patients with stable COPD will be evaluated before and after a 4 month training     program. Each evaluation include a stepwise exercise test on an ergocycle up to the     individual maximal capacity during which minute ventilation (VE), oxygen consumption (VO2),     carbon dioxide production (VCO2), and arterial lactic acid concentration will be measured and     the peripheral muscle strength will be determined with the one repetition maximum for eight     different muscle groups. Percutaneous needle muscle biopsy from the M.vastus lateralis will     be performed before and after the training period in order to determine the fiber-type     proportions. Patients are assigned to one of the following three groups (1) endurance     training consisted of 20 min exercise sessions on a calibrated ergocycle two times a week,     with a target training intensity at 60% of individual maximum oxygen uptake, (2) systemic     weightlifting training two times a week with eight different exercises, each session consist     of 15 repetitions of each muscle group, (3) combination of endurance training and systemic     weightlifting training.      Statistical analysis. Baseline data for all patients enrolled in the study will be compared     by one-way analysis of variance for the three study groups. Results before and after training     will be analyzed by two- way analysis of variance.   "
247686|NCT01091636|"     The current standard treatment for ovarian cancer, tubal cancer, and primary peritoneal     cancer is maximal cytoreductive surgery followed by chemotherapy. Recent randomized trials of     Gynecologic Oncology Group (GOG) revealed the survival gain in intraperitoneal chemotherapy     compared to the intravenous chemotherapy after the optimal cytoreduction in ovarian cancer     (GOG#104, GOG#114, GOG#172). Experts attributed such survival gain to the earlier cycles of     intraperitoneal chemotherapy when adhesion was minimal from extensive cytoreductive     procedures.      Hyperthermia has an anti-cancer activity itself. Especially, hyperthermia promotes     chemotherapy to penetrate deeper into the cancer tissue. Therefore, the combination of     intraperitoneal chemotherapy with hyperthermia theoretically could lead to higher response     rate and better survival outcomes.      *HIPEC: hyperthermic intraperitoneal chemotherapy      There will be an interim analysis when 50% of patients are enrolled.      At the interim analysis, a statistical test will be performed. The nominal significance     levels will be determined later. The exact nominal significance level will be determined     based on the exact number of events at the time of the interim analysis. The Stopping     boundaries will be calculated using an O'Brien-Fleming error spending function   "
247687|NCT01091649|"     The objective of this study is to assess the relative bioavailability of two test tablet     formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a     reference.   "
247688|NCT01091662|"     This is an 18-week, double-blind, multicenter study with gradual conversion from previous     antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial     epilepsy.   "
247689|NCT01091675|"     The goal of this research is to assess the percentage of non-responders to ≥ 2 NSAIDs     candidates a biological therapy that could adequately respond to treatment with etoricoxib     This study confirm the result of a previous study in a wider similar population. Basing on     previous results, the response rate will be assessed by ASASBIO criteria. The efficacy of the     treatment with etoricoxib 90 mg will be assessed at week 4 in a population of patients with     AS who didn't respond adequately to a previous therapy with ≥ 2 NSAIDs.      Those patients that, based on the ASABIO criteria, achieved a sufficient clinical response     will be followed until week 24 to asses the maintenance of the study drug effects.   "
247745|NCT01092403|"     The study will assess the safety, tolerability and clinical activity of ASM-024 in subjects     with mild allergic asthma.   "
247693|NCT01091727|"     This is a prospective, multicentre (7 sites), randomized, double-blind, study comparing     intravesical injection of BOTOX to placebo in 56 subjects with NDO secondary to spinal cord     injury or multiple sclerosis. Study subjects will be randomized to one of the following two     treatment groups:      Group 1 n=28 BOTOX - 300U Group 2 n=28 Placebo BOTOX (saline)      All study subjects will receive one injection cycle (BOTOX 300U or Placebo) at Visit 2     (Treatment, Day 0) as per Supplement III. The study duration is approximately 61 weeks and     consists of a Pre-Treatment Evaluation, a Treatment/Randomization Visit (Visit 2, Day 0),     Telephone Follow-ups at 1, 3 and 4 weeks post-treatment, and Follow-up Visits at 6, 24 and 36     weeks (Visits 3 to 5). At Week 36, subjects will be offered open-label BOTOX 300U and will be     followed for an additional 6 months, returning for evaluations at Weeks 48 and 60.   "
247694|NCT01091740|"     This study try to 1) evaluate the neointimal coverage and malapposition at 3 month after new     zotarolimus eluting stent (Endeavor resolute) and everolimus eluting stent (Xience)     implantation and 2) compare them between ZES resolute and EES at 3 months (early period)     after stent implantation.   "
247695|NCT01091753|"     The purpose of this study is to determine the effect of nocturnal administration of     Anti-hypertensive medications in Non-dippers.      Efficacy variables.        1. ECHO        2. 24hr. horter        3. IMT        4. BUN/crea, urine analysis (microalbulinuria        5. Cardio vascular event.    "
247696|NCT01091766|"     The purpose of this prospective randomised study is to investigate electrocardiographic     alterations after intravascular injection of three different test solutions of bupivacaine     and epinephrine in anaesthetised children up to 16 years of age.   "
247697|NCT01091779|"     Changes of Upper and Lower Limb Blood Flow and Vascular Resistance in Hyperbaric Spinal     Anesthesia for TURP Using Duplex Ultrasonography: Comparison of Normotensive and Hypertensive     Patients.   "
247698|NCT01091792|"     Blood samples will be obtained from newly diagnosed GBM patients treated with combined     radiotherapy (RT), temozolomide (TMZ) and bevacizumab (BEV) at specific time points. The     primary outcome is the shift in T reg cell fraction a defined by determining the proportion     of CD4 cells that are CD4+ CD25.   "
247699|NCT01091805|"     The purpose of this research study is to see if GE reflux events are associated with     increasing levels of pepsin in spit samples. Pepsin is a special protein called an enzyme     that is made only in your stomach. It is not normally found in your throat. Pepsin breaks     down food proteins that you eat to form nutritional building blocks that your body can use to     grow. An enzyme is a substance that helps break down proteins.      Gastroesophageal reflux disease (GERD) is very common in infants and children, but can result     in serious health problems if not accurately diagnosed. The investigators currently do not     have a definitive test to be used as a standard for diagnosing pediatric GERD.      Measurement of pepsin, an enzyme normally produced only in the stomach, has been used as a     non-invasive way to detect gastric aspiration (reflux of stomach fluid into the airway) in     both adults and children, but using pepsin to detect reflux has not been tested. Since pepsin     should not be present in the normal esophagus and respiratory tract, but is always present in     reflux fluid from the stomach, the investigators believe that the more GE reflux the     investigators detect, the higher the levels of pepsin the investigators see in the fluid     collected from the mouth. If patients do not have GE reflux, but have swallowing problems     alone in which food or liquid goes into the airway, the investigators expect that these     patients will have no pepsin in the fluid collected from their mouth.      The investigators will test these hypotheses by measuring pepsin levels from mouth fluid and     comparing them with the number of GE reflux events the investigators find using the     pH/impedance (MII (multichannel intraluminal impedance)) test. Since the investigators are     interested in pepsin levels for all types of reflux - acid and non-acid -the investigators     will study children whether or not they are on acid blocking medicines. The investigators     will also look at pepsin levels in patients whose pH/MII is normal, but have aspiration alone     that the investigators find on a modified barium swallow (MBS) study. The investigators will     measure pepsin levels in healthy children with no reflux symptoms and no swallowing problems     as the investigators controls. The investigators anticipate that this study will show a     positive correlation between GE reflux events and the presence of oropharyngeal pepsin, which     may allow us to use pepsin as a way to test for reflux.   "
247700|NCT01091818|"     Dexmedetomidine will be tested against midazolam in a prospective, randomized, double-blind     study of intensive care children, age 2-17 years.      The investigators' primary hypothesis is that time from end of medication to extubation will     be shorter with dexmedetomidine sedation.   "
247701|NCT01091831|"     This is a multicenter, randomized, open label study designed to compare the efficacy and     safety of lenalidomide with low-dose alkylating agents versus high-dose melphalan followed by     stem cell support in newly diagnosed symptomatic MM patients who are 65 years of age or     younger.   "
247702|NCT01091844|"     Purpose: The purpose of this study is to determine if two different methods of performing a     postoperative voiding trial are equivalent in evaluating urinary retention after gynecologic     surgery.      Participants: The participants in this study will be women who have undergone gynecologic     surgery at UNC-Chapel Hill.   "
247703|NCT01091857|"     Rates of cancer and cardiovascular disease have shown very little improvement over the past     two decades, and the incidence of Type II diabetes mellitus is increasing at an alarming     rate. Recent reports estimate that approximately 30% of total cancer deaths are related to     poor exercise and nutrition, and other reports have suggested that, when taking into     consideration both cardiovascular disease and cancer, inactivity contributes to as many as     250,000 premature deaths per year (Booth et al., 2002). Despite the benefit of regular     physical activity in the prevention of cancer and other debilitating illnesses, 75% of the     U.S. population do not get the recommended amount of physical activity as defined by 30     minutes of moderate intensity physical activity 5 or more days per week (CDC, 2001), and 40%     of the population is completely sedentary (USDHHS, 19960. The objective of the proposed     research is to understand the mediators and moderators of a well-tested individually     tailored, print-based intervention to increase exercise behavior among sedentary adults.     Using a randomized, controlled intervention ton trial, the proposed study will address three     primary and one secondary hypotheses: 1) A previously tested and validated exercise promotion     intervention (c.f., Marcus et al., 1998) is successful at helping sedentary individuals     initiate and maintain a moderate intensity physical activity regimen, as compared to a health     and wellness control intervention, 2) Increases in positive attitudes, perceived normative     support, self-efficacy, and intentions to exercise will mediate the effectiveness of the     intervention, 3) That increased positive mood, and better temperature, stress, and lactate     regulation immediately after exercise challenge (assessed in the laboratory) will moderate     the effectiveness of the intervention, and 4) Secondarily, we will test whether gender,     race/ethnicity, and two recently suggested genetic factors (BDNF and OPRM1) moderate the     effectiveness of the intervention. The rigorous assessment of how and for whom an exercise     promotion intervention is effective will provide information for future development of     intervention strategies and content, as well as allow the targeting of exercise content to     individuals for whom it is most likely to be effective.   "
247704|NCT01091870|"     A Randomized Clinical Trial with security and dose testing of Sildenafil Citrate in patients     with subarachnoid hemorrhage due to a rupture of a cerebral aneurism for prevention of     cerebral vasospasm. The cerebral vasospasm is a decrease in blood flow that occurs when the     intracranial vessels lose their capability of self-control of dilations and contractions.     Patients with subarachnoid hemorrhage without neurological deficits who underwent     endovascular or surgical correction of the aneurysm can participate in this trial. They will     be randomized to a daily doses of 75 mg of Sildenafil, 150 mg of Sildenafil or Placebo from     the third to the 14th day post bleeding. Today there is no proven clinical treatment for     prevention of cerebral vasospasm.   "
247710|NCT01091948|"     Following informed consent, patients will be randomly assigned to oral fiberoptic intubation     or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of     general anesthesia a sealed envelope would be opened to reveal the technique to be used. A     stop watch will be started at the beginning of the procedure. At the completion of intubation     the stop watch will be stopped and the time recorded along with other data. Based on a sample     size estimation process, it is the investigators plan to study fifty patients. The two     techniques will be compared in terms of the average time needed to place the endotracheal     tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure     comparability between the two methods, all intubators will be required to have at experienced     at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.   "
247711|NCT01091961|"     Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective     surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning     of surgery, or to hold them a day prior to the surgery. The patients will be followed for 30     days after surgery to assess any adverse health outcomes.   "
247712|NCT01091974|"     This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of     cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female     breast cancer patients who report sleep disturbances following completion of chemotherapy.   "
247713|NCT01091987|"     The study wants to examine the feasibility of a non-pharmacological approach for insomnia in     nursing homes provided by trained nurses/paramedics and physicians.   "
247714|NCT01092000|"     The purpose of the challenge is to see if we, as the nutrition experts, can follow the     dietary and physical activity guidelines promoted to the public. We have an opportunity to     practice what we preach. Scientific evidence demonstrates, knowledge is not enough to     change ones'behaviors. It is through positive approaches and lifestyle changes that behavior     can be altered. By experiencing the planning, work, and motivation required to make lifestyle     changes we can all be better clinicians.   "
247715|NCT01092013|"     This prospective randomized study aims for determination whether focused simulator based     laparoscopic camera training in novices can improve camera performance in an actual clinical     situations in the same manner as traditional training in the OR does, especially considering     efficient use of training time.   "
247716|NCT01092026|"     A pilot study to assess the feasibility of unrelated umbilical cord blood transplantation     with coinfusion of third-party mesenchymal stem cells after myeloablative or nonmyeloablative     conditioning in patients with hematological malignancies.      This is a multicenter single arm, phase I-II pilot study. The primary objective of this study     is to determine the feasibility of UCB HSCT with co-infusion of third party mesenchymal stem     cells as assessed by the treatment-related mortality at d100 after transplant.      Patient inclusion criteria:      Age 15-60 yrs Patients for whom allogeneic stem cell transplantation is the preferred     treatment option, with the following hematological malignancies:acute myeloid leukemia, acute     lymphoblastic leukemia, high risk myelodysplastic syndrome, advanced lymphoproliferative     disorders, chronic myeloid leukemia (refractory or intolerant to second-line tyrosine kinase     inhibitors), multiple myeloma Informed consent given Patient exclusion criteria Previous     allogeneic transplant Progressive malignant disease Significant organ damage as a     contraindication to allotransplantation Significant psychiatric or neurological disorder     Uncontrolled viral, fungal or bacterial infection Pregnancy HIV positive Patients will     receive either myeloablative or reduced intensity conditioning. One or 2 cord blood     transplants will be transplanted, followed by infusion of a third-party mesenchymal stem cell     transplant Adverse event reporting BHS transplant committee will establish a protocol review     committee which will organize a central monitoring of the study. Within the context of     allogeneic HSCTx many severe events are likely to occur.      Statistics and stopping rules The trial will be stopped at any time that there is reasonable     evidence that the true rate of day +100 nonrelapse mortality exceeds 0.40. It is the     intention to include an initial 20 patients.   "
247717|NCT01092039|"     The purpose of the study will be to assess the efficacy and safety of XIGO administered     orally, three times a day, compared with placebo in patients with the common cold.   "
247718|NCT01092052|"     The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase     inhibitor, in adult patients with advanced/metastatic solid tumors.   "
247719|NCT01092065|"     This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and     effective and whether it can increase the therapeutic window of L-dopa in patients whose     control of their Parkinson's Disease symptoms is limited by the development of dyskinesia     induced by use of L-dopa.   "
247884|NCT01101854|"     This study has two arms: 1) the biopsy arm and 2) the debridement arm. The purpose of the     biopsy arm is to determine whether there are similar patterns of genes being turned on and/or     turned off among people with healing and non-healing wounds. The purpose of the debridement     arm is to (i) identify the nature of bacterial infection and the genes driving the tissue     response to it; and (ii) determine how the biofilm components arrest/paralyze the immune     function.   "
247720|NCT01092078|"     Black men constitute the demographic group with the greatest burden of premature death and     disability from hypertension (HTN) in the United States. But while the disproportionately     high rate of hypertension-related morbidity and mortality is well documented, the epidemic of     colorectal cancer (CRC) among black men is comparatively under-appreciated. For example, CRC     is a leading cause of cancer death in black men with a death rate 50% higher than in white     men. Low rates of screening for CRC in this population contribute significantly to this     problem. The purpose of this randomized controlled trial (RCT) is to evaluate the effect of a     lifestyle intervention delivered through telephone-based motivational interviewing (MINT)     versus a patient navigation intervention on blood pressure reduction and CRC screening.   "
247721|NCT01092091|"     The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is     safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).   "
247722|NCT01092104|"     A double-blind, randomized, placebo-controlled, dose-escalating study to assess the antiviral     activity, safety, tolerability, and pharmacokinetics (PK) of the CCR5 antagonist TBR 652     monotherapy dosed orally once daily (QD) for 10 days in HIV 1-infected, antiretroviral     treatment-experienced, CCR5 antagonist-naïve patients.   "
247723|NCT01092117|"     The primary objectives of this study are to determine whether the Ovation Abdominal Stent     Graft System is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in     those patients considered to be suitable candidates for open surgical repair.   "
247777|NCT01092819|"     Current literature has only limited information on the natural history of acute ischemic     stroke from large vessel occlusion in a stroke cohort who presents within 8 hours from     symptom onset, particularly on 90 day functional outcome as defined by the mRS. Data from     this trial will advance our knowledge on this important topic and may serve as a bench mark     for future trials   "
247724|NCT01092130|"     The renin-angiotensin system (RAS) is a regulatory system that plays an essential role in     patients with chronic heart failure (CHF). Plasma renin activity (PRA) is a strong and     independent predictor of outcome, also in the presence of ACE inhibitors (ACE-i) and/or     angiotensin receptor blockers (ARBs). Recently, it has been shown that vitamin D regulates     renin transcription by activating the vitamin D receptor (VDR). Thus, specific activation of     the VDR represents a novel target for therapeutic intervention in CHF. Currently, clinical     data are lacking. The investigators aim to investigate the effect of the administration of     vitamin D in patients with CHF.   "
247725|NCT01092143|"     This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in     patients with asthma who do not take inhaled corticosteroids.   "
247726|NCT01092156|"     This study is a randomized controlled trial to evaluate the effectiveness of different     approaches to prenatal teaching of infant latch.   "
247727|NCT01092169|"     Sickle cell nephropathy is a known complication of sickle cell anemia (SCA) manifested by     increase in glomerular filtration rate (glomerular hyperfiltration) and results in     proteinuria and chronic renal failure.      Our goal is to examine the prevalence of proteinuria and microalbuminuria as an early     predictive factor of glomerular injury, among young people who suffer from SCA as well as     those who suffer from combined sickle cell/beta-thalassemia.   "
247728|NCT01092182|"     Background:        -  Burkitt lymphoma/leukemia (BL) is highly treatable, but most of the standard therapies          require multiple doses of intensive chemotherapy that may require long hospital stays          and frequently have severe side effects. In addition, BL is a fairly common type of          cancer in patients who also have human immunodeficiency virus (HIV), but treatment          outcomes are poor because standard treatments do not work very well in HIV-positive          patients and the more intense treatment regimens are highly toxic. New approaches are          needed that expand the ways to treat BL with the same efficiency but with reduced side          effects.        -  DA-EPOCH-R is a standard chemotherapy treatment that consists of the drugs etoposide,          prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. It may be able to          treat BL with similar effectiveness but with fewer side effects. Researchers are          interested in confirming the results of previous studies that investigated the          effectiveness of DA-EPOCH-R in treating BL.      Objectives:      - To determine the safety and effectiveness of DA-EPOCH-R in treating Burkitt lymphoma.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with Burkitt lymphoma and have     not had any prior chemotherapy treatments.      Design:        -  Individuals will have a series of blood and other tests to determine their suitability          for participating in the study. Eligible participants will be divided into high-risk and          low-risk groups based on their disease prognosis and the possibility that the BL may or          already has spread into the central nervous system.        -  Participants will receive intravenous infusion of the six chemotherapy drugs in          DA-EPOCH-R in 21-day treatment cycles. The exact doses will be adjusted depending on          participants white blood cell counts and other tests.        -  High-risk participants will receive six cycles of DA-EPOCH-R. To treat BL that may have          entered the central nervous system, high-risk participants will also receive infusions          of other chemotherapy drugs into their spinal fluid.        -  Low-risk participants will receive up to six cycles of DA-EPOCH-R, with an additional          dose of rituximab during each cycle.        -  Frequent blood and urine tests will be performed during treatment, as well as body          imaging scans and other tests of cancer progression as directed by the study doctors.          Participants will receive additional medicines to help prevent possible adverse side          effects of DA-EPOCH-R.        -  Participants who respond successfully to the treatment will be asked to return for          follow-up exams every 3 months for the first 18 months, then every year for the next 3          years. Participants who do not respond successfully to the treatment will be given the          opportunity to participate in additional research and treatment protocols, if any are          available.   "
247729|NCT01092195|"     Background:        -  Gardasil , a recently approved vaccine for the sexually transmitted human papillomavirus          (HPV), provides immunity to four types of HPV that are associated with genital warts and          cervical, vaginal, and vulvar precancer and cancer. The vaccine has been shown to be          highly effective in preventing infection with these HPV types and was approved for use          by the Food and Drug Administration.        -  More research is needed about the vaccine s ability to induce immunity in individuals          with suppressed immune systems, such as those who have had other kinds of cancer          treatment such as stem cell transplant. Genital warts, precancer, and cancer have been          reported as a late complication after stem cell transplant. Researchers are interested          in determining whether the HPV vaccine is safe to give and able to induce immunity in          female stem cell transplant recipients, their female donors, and healthy female          volunteers.      Objectives:      - To assess the safety and immune response of the HPV vaccine in female recipients of stem     cell transplants who are either off or on stable doses of immunosuppression.      Eligibility:        -  Females between 18 and 50 years of age who have had allogenic stem cell transplants.        -  Healthy female volunteers, including stem cell donors, are also eligible for this study.      Design:        -  Participants will be screened with a physical examination, blood and urine tests, and          saliva samples, and will be asked to complete a sexual quality of life questionnaire.        -  Sexually active participants will also have a routine gynecologic evaluation.        -  Participants will receive three HPV vaccinations according to the standard vaccination          schedule (with the second and third following 2 and 6 months after the first).          Participants will record their daily temperature and any reactions to the vaccine on a          vaccine report card for 1 week after each vaccination.        -  Participants will have clinic visits for further testing 2, 6, 7, and 12 months after          receiving the first HPV vaccine.   "
247746|NCT01092416|"     This is a prospective, single-arm, multi-center study to evaluate the safety and performance     of the OAS in treating de novo, severely calcified coronary lesions in adult subjects. Study     is going to enroll up to 429 subjects in up to 50 U.S. study sites. The primary safety     endpoint is 30-day MACE and primary efficacy endpoint is procedural success. All subjects     will be treated with the orbital atherectomy system and adjunctive stent. All subjects will     be followed in clinic at 30 days. Additionally, all subjects will have an annual phone call     or clinical follow up at each anniversary until study is closed.   "
247885|NCT01101867|"     The purpose of this study is to determine whether mealtime insulin results in better control     of blood sugar than a fixed meal dose in hospitalized patients.   "
247947|NCT01102673|"     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK)     and preliminary food effect of PF-04991532 following single escalating oral doses in healthy     adult subjects.   "
247730|NCT01092208|"     Background:        -  Researchers who are studying autism spectrum disorders are interested in developing a          collection of research samples from both children with autism and healthy individuals,          some of whom may be related to the children with autism.        -  The genetic condition tuberous sclerosis, which can cause the growth of benign tumors in          the brain and other parts of the body, is also linked with autism. Researchers have been          able to determine the specific genetic mutations involved in tuberous sclerosis, and as          a result are interested in studying the genetic information of children who have both          tuberous sclerosis and autism, as well as tuberous sclerosis without autism.      Objectives:      - To develop a collection of DNA samples from blood and skin samples taken from children with     autism and/or tuberous sclerosis, as well as healthy volunteers.      Eligibility:        -  Children between 4 to 18 years of age who have autism and/or tuberous sclerosis, or are          healthy volunteers.        -  Some of the healthy volunteers will be siblings of children with autism.      Design:        -  Participants will be screened with a medical history and a physical examination, and may          also have a genetic evaluation.        -  Participants will provide a blood sample and a skin biopsy for further study.        -  No treatment will be provided as part of this protocol.   "
247731|NCT01092221|"     The objective of the study is to evaluate the efficacy of allopurinol, compared to placebo,     as add-on to mood stabilizers and/or antipsychotic in the treatment of patients with bipolar     disorder, in a manic episode.   "
247733|NCT01092247|"     The aim of the study is, to study the efficacy of the ketogenic diet in delaying or     preventing recurrence and tumor growth progression of patients who have been previously     treated by concomitant chemoradiotherapy (6 months) for high-grade glial tumors.      It will be an open-label trial of nutritional intervention for up to 1 year. An interim     analysis of the data will be carried out to assess safety, compliance and efficacy of the     diet. This will be reviewed by both SHS and the Clinical trial team.   "
247734|NCT01092260|"     The purpose of this study is to validate a feasible, safe and reliable iohexol plasma     clearance method in routine monitoring of the renal function (GFR) in children.      Different parameters of renal function will be compared to the gold standard multiple sample     points procedure of iohexol clearance.   "
247735|NCT01092273|"     Bimatoprost has been shown to provide effective IOP lowering in patients of all races.     Conversely, travoprost has been shown to be more effective in black patients than in     Caucasians in some studies. However, Noecker et al 2004 compared bimatoprost with travoprost     in African-Americans with glaucoma or OHT, and found that bimatoprost was more likely than     travoprost to achieve target pressure at 3 months.      These racial differences in efficacy of these medications warrant further investigations. The     investigators study aim to compare the IOP-lowering efficacies of bimatoprost and travoprost     in an Egyptian population with primary open-angle glaucoma (OAG) or ocular hypertension     (OHT).   "
247736|NCT01092286|"     The goal of the study is to determine effect of coach-led neuromuscular warm-up on     non-contact, lower extremity (LE) injury rates among female athletes in a predominantly     non-white public high school system. The investigators hypothesized the warm-up would reduce     non-contact LE injuries.   "
247737|NCT01092299|"     Part 1: The purpose of this study is to determine the pharmacokinetic profile of 4 different     Extended/modified-release formulations and one immediate release formulation of AZD1446. In     addition the food effect on AZD1446 pharmacokinetics will be investigated.      Part 2: To asses the safety and tolerability of the selected formulation(s) from part 1 in     elderly healthy volunteers.   "
247738|NCT01092312|"     The purpose of this study is to determine whether the percentage cases which have ideal     mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting     blocks is higher than those without the use of Signature when measured immediately     post-operatively.   "
247739|NCT01092325|"     A Phase 1-2a Study of CXL-1020-01 in Patients with Stable Heart Failure   "
247740|NCT01092338|"     Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune     function, growth, muscle, bone, and inflammatory status in children, adolescents and adults     with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy     using clinically important outcomes, and this will overcome the critical barrier for use of     vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit     D supplementation may prove to be an effective and feasible treatment for symptoms and     prevention of side effects for people of all ages living with HIV/AIDS in the US and around     the world.   "
247741|NCT01092351|"     The study aims to investigate bacteriological efficacy of a nitrofurantoin formulation given     twice daily for seven days in the treatment of adult patients with microbiologically     confirmed uncomplicated urinary tract infection.      Additional study objectives are to evaluate clinical efficacy as well as safety and     tolerability of the nitrofurantoin formulation.   "
247742|NCT01092364|"     Weight gain accelerates during early adulthood, and leads to the health consequences of     obesity (high blood pressure, diabetes, heart disease, etc). Most weight loss studies enroll     middle-aged adults. This study tests the hypothesis that a weight loss intervention that     builds on prior research evidence but is enhanced with technological innovations will lead to     weight loss in a diverse group of overweight and obese adults aged 18-35 years. The     technology intervention, using cell phone applications, will be compared to an advice only     control group and to a group receiving a more traditional personal coaching intervention.   "
247743|NCT01092377|"     The aim of this study is to determine if providing iron and a mixture of DHA and EPA, alone     and in combination, to children with iron deficiency and poor n-3 fatty acid intake will     improve their cognitive performance, activity levels and immune system.      Additionally, the effects on iron and fatty acid status, and gut microbiota, will be     assessed.   "
247744|NCT01092390|"     In this application the investigators describe plans for a randomized controlled cross-over     trial to determine the effects of omega-3 fatty acid supplementation on urine protein     excretion in 30 adults with diabetes (NIDDM) and kidney disease defined by the presence of     proteinuria.   "
247747|NCT01092429|"     Development of myocardial ischemia, and/or myocarditis would induce different changes in     myocardial contraction behavior pattern,which maybe very subtle, and may not be detected by     the 2D and m-mode echocardiography examinations. According to tissue Doppler imaging(TDI),     they can be depicted by different models of echo with higher frame rates. In addition, many     studies using TDI have significantly contributed of efforts to evaluate systolic and     diastolic function and prognosis.      This study assess the value of the indices of left ventricular function obtained by using TDI     in patient with coronary artery disease(CAD). We hypothesized that TDI will add incremental     value for regional wall motion abnormality of CAD and its prognosis.   "
247748|NCT01092442|"     The purpose of this study is to collect long-term follow-up data of the CryoValve SG     Pulmonary Human Heart Valve.   "
247749|NCT01092455|"     The purpose of this study is to determine whether the use of Citrasate®, citric acid     dialysate enables the reduction of the heparin N (anticoagulant) dose in patients undergoing     hemodialysis.   "
247750|NCT01092468|"     This study is to compare the efficacy of Harmonic Scalpel with conventional diathermy     technique in terms of reducing elevation time and perioperative complications of perforator     flaps for head and neck reconstruction.   "
247751|NCT01092481|"     This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified     FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6     or CAPOX treatment in terms of disease free survival in patients with stage II/III colon     cancer.   "
247778|NCT01092832|"     The purpose of this study is to determine whether voriconazole is safe and effective for the     treatment of serious Candida infection and Candida infection of the esophagus in children and     adolescents.   "
247752|NCT01092494|"     Ovarian endometriotic cyst (endometrioma) is one of the most common endometriotic lesions,     and conservative laparoscopic surgery is the treatment of choice. However, the recurrence     after surgery is common.      As repetitive surgery leads to morbidities and ovarian function decrease, recurrence after     surgery frustrates both patients and clinicians. In this aspect, medical treatments have been     offered after surgery to prevent or delay the recurrence. Gonadotropin-releasing hormone     agonist (GnRHa) is frequently used in women with advanced endometriosis, but the efficacy is     rather controversial. On the other hand, it has been demonstrated that oral contraceptives     (OCs) could reduce or delay endometrioma recurrence, but data are still limited.     Consequently, no one type of postoperative medical therapy has been shown to be superior in     reducing the recurrence of endometrioma.      The rationale of postoperative medical therapy is that it could eradicate microscopic lesions     which were not found and not treated sufficiently during surgery. Therefore, the maintenance     of strongly suppressed condition induced by postoperative GnRHa treatment by addition of OCs     could be a promising treatment to prevent the recurrence, but it has not been widely     investigated.      We performed this retrospective cohort study to evaluate the efficacy of cyclic monophasic     low-dose OCs as a maintenance therapy after GnRHa treatment for the suppression of     endometrioma recurrence.   "
247753|NCT01092507|"     The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric     virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in     infants and toddlers.      Primary Objective:        -  To demonstrate the non-inferiority of the antibody response 28 days after vaccine          administration of one dose of JE CV (administered on Day 0) compared to the antibody          response after one dose of the SA14-14-2 control vaccine (administered on Day 0).      Secondary Objectives:        -  To describe the immune response to JE in both vaccine groups in JE-CV virus and          SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2          vaccine        -  To describe the safety profile in all vaccinated subjects up to 28 days and all serious          adverse events (SAEs) up to 6 months after vaccination.        -  To describe only related SAEs and all death from 6 month to 12-month follow-up.   "
247754|NCT01092520|"     Children with healing burns often suffer from pruritus that may continue for many months.     Pruritus can be very distressing to the child and can interfere with sleep, activities of     daily living, and rehabilitation therapy. Additionally, constant scratching of skin grafts     may result in damage that requires further surgery, thus putting the patient at additional     risk and adding to health care costs. Although the size of the burn injury is a risk factor     for pruritus, almost 50% of patients with small burn injuries reported moderate or severe     pruritus.   "
247755|NCT01092533|"     The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of     enteric-coated mycophenolate sodium (Myfortic®) in combination with low-dose corticosteroids     (Decortin H®) compared to a monotherapy with low-dose corticosteroids (Decortin H®) in     subjects with chronic intraocular inflammation (non-infectious intermediate uveitis).   "
247756|NCT01092546|"     To determine the level of association between the quantitative estimates of brain uptake of     [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of     amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement     for NPH.   "
247757|NCT01092559|"     This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and     device performance of the GeNO nitrosyl delivery system during right heart catheterization     (RHC) in participants with pulmonary arterial hypertension (PAH). All participants will     receive inhaled nitric oxide in oxygen or nitric oxide in air delivered by nasal cannula.     Hemodynamics, clinical laboratory and clinical assessment data will be collected on all     participants to evaluate safety.   "
247758|NCT01092572|"     Cystic fibrosis (CF) is a lethal genetic condition that affects 30,000 children and adults in     the United States. Although CF management has improved substantially over the past two     decades, there is still no cure and most patients with CF die before reaching their 50th     birthday, largely due to lung failure. There is growing evidence that excess lung and blood     inflammation that occurs in response to infections in the lungs cause CF patients to be     sicker. Simvastatin is a drug that is used to lower cholesterol, but many researchers have     found that this drug may also treat blood and lung inflammation. In this study, we will     determine whether or not simvastatin can treat blood and lung inflammation in patients with     CF and most importantly determine whether or not it can make these patients feel better and     have better lung function.   "
247759|NCT01092585|"     Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is     being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line     therapy to patients with advanced melanoma and normal serum lactate dehydrogenase (LDH).   "
247760|NCT01092598|"     Older adults with schizophrenia are a growing segment of the population yet their physical     health status is poor. In order to design effective interventions, the contributing factors     must be understood. Current data suggest the side effects of psychiatric medications,     sociodemographic factors, and health care disparities are a few of the reasons for the poor     physical health. There are only limited data on the impact of psychiatric symptomatology and     neurocognition on the physical health of this population. These limited data indicate that     worse symptomatology and poorer neurocognition may negatively impact physical functioning, a     critical component to optimal physical health. The purpose of this pilot study is to begin to     fill this knowledge gap by: 1. examining the relationship between neurocognitive function and     physical function and 2. Examining the relationship between schizophrenia symptoms and     physical function. 3. Examining the relationship between serum Brain Derived Neurotrophic     Factor (BDNF) and physical function. Using a descriptive correlational design, 50 older     adults (55+) with schizophrenia or schizoaffective disorder will be assessed. Bivariate     associations will be used to examine the relationship between key variables including     schizophrenia symptoms as measured by the Positive and Negative Syndrome Scale (PANSS),     neurocognitive function as measured with the MATRICS Consensus Cognitive Battery (MCCB),     Physical Function as measured objectively by the Timed Get Up and Go (TGUG) test and     subjectively with the physical component summary subscale of the 12-item short form health     survey (SF-12), and serum BDNF. These pilot data will lay the foundation for a future health     promoting intervention.   "
247761|NCT01092611|"     The purpose of this long-term follow-up study is to assess the long-term health status of     HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the     investigational HIV vaccine 732462. This study will provide additional data concerning the     long-term benefits/risks associated with vaccination.      No vaccine will be administered during the study period. Vaccines were administered during     the primary studies.   "
247762|NCT01092624|"     This study will evaluate the effect of pessary therapy, with and without Solifenacin     (Vesicare), on symptoms of over active bladder and bladder function in women with overactive     bladder symptoms and pelvic organ prolapse.      Study Hypotheses:      Null hypothesis, HO: Reduction of anterior vaginal wall prolapse and treatment with     solifenacin does not improve overactive bladder symptoms more than reduction of anterior     vaginal wall prolapse and placebo.      Alternate hypothesis, HA: Reduction of anterior vaginal wall prolapse and treatment with     solifenacin does improve overactive bladder symptoms more than reduction of anterior vaginal     wall prolapse and placebo.   "
247763|NCT01092637|"     The aim of this study is to determine the efficacy of therapeutic hypothermia following     perinatal asphyxia on neurological and neuropsychological outcomes and also to assess     academic attainment and any additional health, societal or educational costs associated with     changes in outcome as a result of the intervention. This study will determine whether the     apparent initial benefits of cooling are maintained in the longer term.      Perinatal asphyxia (a lack of oxygen occurring around the time of birth) may have long term     consequences on brain functioning, which may be altered by treatment with hypothermia     (cooling). Currently, there is no information on the effect of cooling on outcome beyond 18     months of age. We intend to assess at 6 - 7 years of age, the children that participated in     the TOBY trial of whole body cooling following perinatal asphyxia and compare between the     children that had received the cooling treatment soon after birth and those that were not     treated with cooling, the number that survived with an intelligence quotient (IQ) greater     than 84, the presence and severity of disabilities, educational attainment and the economic     impact on families and service providers. If possible, children will be assessed in their     school, with the option of alternative venues such as home or clinic if required.      During the assessment a paediatrician will conduct a neurological examination. A psychologist     will administer psychometric tests to evaluate cognitive, behavioural and motor development.     Questionnaires completed by parents and teachers will complete the data collection. Economic     factors will also be assessed in the parent questionnaire.      Each child will have contact with the assessors during one school day with appropriate     breaks. Assessments will take place over a period of 3 years.   "
247764|NCT01092650|"     The purpose of this research study is to better understand how people respond to     cancer-causing chemicals in cigarette smoke. Some people are able to get rid of these     chemicals as harmless agents while others suffer damage to their cells that can ultimately     result in cancer. We hope to develop a better understanding of how we can identify the people     who are in danger of getting cancer. Participants will complete questionnaires regarding     their health and smoking history. We will take blood samples to look at genes which determine     how the body breaks down some tobacco-related toxins. Participants will be given a small     amount of liquid to drink, containing alcohol, water, and a compound called deuterated     phenanthrene (DP), which is found in cigarette smoke and in the environment. Phenanthrene is     non-toxic and does not cause cancer, but this compound is broken down by the body in the same     way as cancer-causing agents. We will follow the pathway of this compound as it is broken     down in the body.   "
247765|NCT01092663|"     This study will assess the effects of colesevelam, alone or in combination with sitagliptin,     on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise   "
247766|NCT01092676|"     Ankle sprains are common in children, and optimal pain management has not been determined.      We hypothesize that children age 7-17 years of age with acute ankle sprain randomized to     receive regular dose ibuprofen will show a greater improvement in degree of     pain,disability,swelling and tenderness four days following injury as compared to children     who take ibuprofen only intermittently for pain relief during the same time period.   "
247767|NCT01092689|"     We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic     cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived     carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly     sensitive technology to determine if this carcinogen binds to DNA in the pancreas.   "
247848|NCT01101061|"     The purpose of this study is to assess the safety, tolerability and potential immune response     of AMG 785 following single subcutaneous (SC, injection under the skin) dose administration     in healthy postmenopausal Japanese women.   "
249487|NCT01121770|"     The purpose of this study is to determine a preventative dose of study drug, Arixtra® for     patients with kidney disease. We will measure the blood levels of Arixtra® in patients with     kidney disease and develop guidelines for dosing.   "
247768|NCT01092702|"     The goal of this proposal is to explore the potential effectiveness of varenicline to treat     tobacco dependence among recovering alcoholic smokers who, as a group, are at high risk for     tobacco-caused morbidity and mortality. In this open-label phase II clinical trial, we are     proposing to enroll 32 recovering alcoholic smokers who are motivated to stop smoking. After     the initial up titration of varenicline in week 1, all 32 subjects will receive a total of 2     mg/day of varenicline for 12 weeks. In addition to receiving varenicline, all subjects will     receive brief behavioral counseling and our standard intervention at each visit during     participation in the study.   "
247779|NCT01092845|"     PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats,     which suggests that PF-04457845 is active in rat's brains. This study is designed to see     whether this is also the case in man.   "
247780|NCT01092858|"     The design of the study is a standard double-blind design, which is needed in this study to     allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of     testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in     comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks,     to monitor the increase as well as the steady state of the parameters assessed.   "
249439|NCT01120860|"     The primary purpose of this study is to apply state-of-the-art Magnetic Resonance Imaging     (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI) techniques to measure changes over     time in the brain.   "
247769|NCT01092715|"     Neck pain is a common problem in our society, accounting for 20% of all chiropractic visits.     Physical therapy interventions for chronic neck pain have been chosen based on the patient's     symptoms and examination findings. These interventions include superficial and deep heat,     massage, traction, manual therapy, and exercise programs. There is little controlled research     addressing the efficacy of these therapies. Although many of these interventions provide some     patients with pain relief and increased function, studies often utilize multiple     interventions on the same subject such as heat, ultrasound, cervical traction, range of     motion exercises, making interpretation of the results difficult. Much of the literature to     date has focused on studies of subjects suffering from acute neck pain. Many of these studies     suggest that subjects report decreased pain, decreased disability and increased cervical     spine active range of motion. There are no controlled studies comparing the effects of spinal     mobilization and standard physical therapy on subjects with chronic neck pain. The object of     this study is two fold: 1) to determine the score variability of two neck disability     questionnaires )both baseline and change scores) to be used in sample size calculations, and     2) to establish the ability to recruit, treat and follow sufficient numbers of subjects     needed for a full clinical trial. The ability to predict outcomes of neck pain treatment will     lead to more appropriate therapies and an avoidance of unnecessary treatments.   "
247770|NCT01092728|"     The goal of this clinical research study is to compare how the drug Sprycel (dasatinib) can     help to control the tumor in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged     Melanoma. The safety of this drug will also be studied.      Objectives:      Primary Objectives:      1. To compare the biological response of tumors With and Without Resectable Tumors from     patients with acral, or mucosal melanomas after treatment with dasatinib.      Secondary Objectives:        1. To assess the safety and tolerability of dasatinib in this patient population           Completely Resectable Acral, Chronic Sun-damaged (CSD), and Mucosal Melanoma:        2. To assess the median time to recurrence and overall survival of patients with completely          resectable acral, CSD, and mucosal melanoma treated with dasatinib        3. To assess whether FDG-avidity and KIT phosphorylation responses after treatment with          dasatinib predicts prolonged time to recurrence and/or overall survival in patients with          completely resectable acral, CSD, and mucosal melanomas           Not Completely Resectable Acral, CSD, and Mucosal Melanoma:        4. To assess the response rate, progression free survival, and overall survival of patients          with acral, CSD, and mucosal melanoma treated with dasatinib        5. To assess whether FDG-avidity and KIT phosphorylation responses after treatment with          dasatinib predicts response rate, progression free survival, and/or overall survival in          patients with acral, CSD, and mucosal melanomas   "
247771|NCT01092741|"     Objectives:      Primary endpoints:      To achieve low levels of Polymerase Chain Reaction (PCR) ratios of B-cell antigen receptor     (Bcr-Abl)/Bcr (molecular CR) in a significant proportion of patients after 12 months of     higher doses (800 mg daily) of Gleevec therapy To increase the proportion of patients     achieving a complete cytogenetic response in patients with Ph-positive chronic phase CML     using initial higher dose Gleevec therapy.      Secondary endpoints:      To evaluate the durations of PCR negativity, cytogenetic response, hematologic control, and     survival.      To analyze differences in response rates and in prognosis within different risk groups and     patient characteristics   "
247772|NCT01092754|"     The objective of this study is to characterize the safety, efficacy and pharmacokinetic     profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient     population.   "
247773|NCT01092767|"     The purpose of this study is to determine if the Valiant stent graft is safe and effective in     treating patients who have a blunt thoracic aortic injury (BTAI). BTAI is when the aorta has     been injured due to traumatic force to the chest area. It is commonly caused by motor vehicle     accidents. In most cases it is life threatening and the standard treatment is surgery. Many     times when a person has a BTAI they also have other injuries that can affect the results of     the surgery.      Since stent grafting has been an effective way to treat other aortic conditions such as     aneurysms (bulge in aorta wall), it is believed that the Valiant stent graft would be     effective in treating BTAI. A stent graft is a woven polyester tube (graft) supported by a     metal frame of strong but flexible nitinol (type of metal) springs (stent) that is placed in     the aorta to help seal the injury and keep it from bleeding.   "
247774|NCT01092780|"     This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime     sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS)     who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy.     The goal of this study is to determine the effect of MK-7288 after single dose administration     on promoting wakefulness as measured by sleep latency on Maintenance of Wakefulness Tests,     and on driving performance as measured by standard deviation of lane position in simulated     driving (country vigilance driving).   "
247775|NCT01092793|"     Atherosclerotic coronary heart disease is a condition thought to involve low-grade     inflammation. Several reports, clinical and epidemiological, have demonstrated that intake of     fish oil may be beneficial in attenuating the inflammatory process. Still, however, there are     lacking data in respect to whether differences in composition of various marine oils may     influence the inflammatory status differently.      The hypothesis of the current study is that extract from the antarctic krill (Euphausia     superba) is better than traditional fish oils when compared head-to-head with balanced     composition of omega 3 content on inflammatory status.   "
247849|NCT01101074|"     This observational study will evaluate the safety and effectiveness following administration     of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine through both an ad     hoc active monitoring system and a passive surveillance of hospitalization in a large cohort.   "
247776|NCT01092806|"     One of the main side-effects of tacrolimus in solid organ transplanted patients is post     transplant diabetes mellitus (PTDM). It is not known if different pharmacokinetic properties     influence the risk of developing PTDM. It is possible that it either is high peak     concentrations of high overall systemic exponation that is responsible for the effect on     insulin secretion. With the new slow-release formulation of tacrolimus (Advagraf) a different     pharmacokinetic profile is introduced to patients and it is of interest to investigate if     this affects insulin secretion and insulin sensitivity of patients.      Hypothesis: The pharmacokinetic profile of tacrolimus affects the insulin secretion in renal     transplant recipients.   "
247781|NCT01092884|"     We will assess whether oral supplementation with Polypodium leucotomos, a commercially     marketed fern extract, improves facial melasma in Hispanic women with moderate to severe     melasma. Subjects will be randomized to either Group 1, which will receive oral Polypodium     leucotomos extract plus topical sunscreen, or Group 2, which will receive oral placebo plus     topical sunscreen. The study will last 12 weeks, and we hypothesize that the Polypodium     leucotomos group will have more improvement in their melasma compared to the placebo group.   "
247782|NCT01092897|"     The purpose of the study is to determine whether circulating molecular and cellular     biomarkers are predictive of imatinib effect on pulmonary artery hypertension.   "
247783|NCT01092910|"     To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in     subjects suffering from mild to severe hearing loss.   "
247784|NCT01092923|"     Nitrous oxide is the oldest anaesthetic agent still in routine use today. Despite huge     changes in the pharmacology of volatile anaesthetic agents and intravenous anaesthetics, the     unique properties of nitrous oxide have maintained its place in modern practice, where it is     used in combination with other, more powerful inhaled agents, such as sevoflurane. It has     useful analgesic properties, unlike the other agents used today, and its inclusion reduces     the concentration of other agents required to maintain an adequate depth of anaesthesia for     surgery.      In particular, its low solubility in body tissues gives it a unique pharmacokinetic profile,     with rapid washin and washout from the body. It has been shown to have a similar effect on     the speed of uptake of accompanying agents like sevoflurane (the second gas effect), which     have much slower pharmacokinetics. A recent study by us suggested that this promotes faster     and smoother onset of anaesthesia, as measured using the standard monitor of depth of     anaesthesia (the BIS monitor). This finding requires confirmation prospectively in a larger     group of patients. The investigators further hypothesise that a similar effect also exists on     washout of sevoflurane at the end of the procedure, promoting quicker recovery (emergence)     from anaesthesia. This has never been previously demonstrated. This information will help     better define the place of nitrous oxide in achieving optimal outcomes in modern anaesthetic     practice. The investigators propose to conduct a simple study to measure the effects of     nitrous oxide washin and washout on exhaled concentrations of accompanying sevoflurane during     both induction of anaesthesia and emergence, and identify any accompanying effect on the rate     of change in depth of anaesthesia using BIS. The investigators hypothesise that the rate of     fall of exhaled sevoflurane concentration at the end of anaesthesia will be more rapid in the     group of patients breathing a gas mixture containing nitrous oxide, and that the rate of fall     of BIS on induction and the rate of rise of BIS on emergence will be faster in the nitrous     oxide group.   "
247785|NCT01092936|"     The present study is part of an international program and deals with the translation and     validation program for the Italian version of the MDS-UPDRS.      The program will be articulated in three steps:        -  Phase I: translation and back-translation of the MDS-UPDRS in Italian (completed)        -  Phase II: Cognitive testing. This step is aimed at a preliminary testing of a subset of          potentially culturally sensitive items in a limited set of PD patients (approximately          10). Should this phase identify issues in the understanding and ease of use of some          items a revised translation of some individual items might be envisaged.        -  Phase III: large validation testing: this phase will involve 350 PD patients from 12-14          Italian PD centres.      The IRIS protocol deals with phase II and III of the program.   "
247786|NCT01092949|"     To evaluate the feasibility of functional MRI method developed in an animal model and to     construct normal reference ranges for in vivo placental perfusion using functional MRI. This     will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16     to 32 weeks' for fetal reason in a tertiary referral center.   "
247787|NCT01092962|"     Idiopathic nephrotic syndrome is steroid-sensitive in more than 90% of cases in children.     However 60% of cases are steroid dependent and required treatment with immunosuppressive     agent. Cyclophosphamide and ciclosporin are used for long time to reduce steroid dependency,     but duration of these treatments should be restricted because of gonadotoxicity for     cyclophosphamide and nephrotoxicity for ciclosporin.      Mycophenolate mofetil appears as an alternative treatment without gonadotoxicity and     nephrotoxicity. However, contrary to cyclophosphamide, mycophenolate mofetil does not seem to     have a residual action so that treatment must be maintained during months or years.      The aim of the study is to compare efficacy of cyclophosphamide and mycophenolate mofetil in     steroid dependent nephrotic syndrome in children.   "
247788|NCT01092975|"     The purpose of this study is to determine if applying the drug phenylephrine to the inside of     the mouth can be done safely and is tolerable to use in cancer patients receiving radiation     to the Sub-mandibular lymph nodes.   "
247850|NCT01101087|"     Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to     determine whether or not the use of Taurolock (a catheter lock solution) can prevent     bacterial peritonitis in patients undergoing peritoneal dialysis.   "
247851|NCT01101100|"     This study is an open-label extension of study 20090062 to evaluate extended subcutaneous     dosing of AMG 827 for up to 362 weeks.   "
247789|NCT01092988|"     The first magnetic resonance-guided focused ultrasound (MRgFUS) treatment of uterine fibroid     using the ExAblate 2000 system was performed in 2001. Since then, more than 5000 treatments     were done in more than 60 different hospitals around the world. The experience accumulated in     this novel treatment was collected by InSightec and implemented into software and hardware     updates, clinical tips and guidelines, all aimed to improve the clinical results and their     durability, while maintaining a high level of safety.      Based on extensive clinical experience and our internal research and development effort goals     toward continuous improvement in ExAblate treatment safety and performance, limited changes     have been made to the current ExAblate system. This modified ExAblate system version is     designated as the ExAblate 2100 UF V2 system.      The modifications are believed to improve system's friendliness to the user, without     introducing new risks or other issues of safety of the device, and should not have any     negative impact on the safety or technical efficacy of the treatments for patients.   "
247790|NCT01093001|"     The effect of cardiac pacing leads on tricuspid regurgitation is unclear. This study will     determine whether using a smaller diameter leads and an alternate position in the ventricle,     the proximal septum, will reduce tricuspid regurgitation than larger leads placed in the     apex.   "
247804|NCT01093183|"     This phase I/II trial studies the side effects and best dose of lenalidomide when given     together with cyclophosphamide and to see how well they work in treating patients with     previously treated hormone-refractory prostate cancer. Lenalidomide may stop the growth of     prostate cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving lenalidomide together with     cyclophosphamide may kill more tumor cells.   "
248373|NCT01106560|"     This is a single-centre, randomised, prospective clinical follow-up study to evaluate     clinical outcome and gait analysis after total hip arthroplasty using the standard     postero-lateral approach or the minimally invasive anterior approach.   "
247791|NCT01093014|"     The loss of muscle contraction (paralysis) removes an important stimulus for maintenance of     overall health for individuals with complete spinal cord injury (SCI). Increased protein     catabolism (atrophy) limits important stresses to the skeletal system. Bone loss doubles the     risk of fracture and contributes to increased mortality in Veterans with SCI. Metabolic     syndrome and diabetes lead to heart disease in Veterans with SCI at higher rates than the     general population. Exercise methods to sustain muscle tissue, bone density, and metabolic     stability after SCI are lacking scientific justification. If left unchecked, the secondary     complications of SCI can be health limiting or even life threatening to Veterans with     paralysis. The importance of maintaining the health of the musculoskeletal system after SCI     has never been greater as a cure for paralysis may become a reality. Contemporary     rehabilitation interventions lack the ability to functionally load muscle tissue, quantify     the dose of load, stress the cardiovascular system, monitor the overall stresses during daily     exercise training, or offer portability to improve compliance with the exercise. The     long-term goal of this project is to establish the optimal dose of muscle and bone stress     during functional exercise in order to improve the health of Veterans with complete     paralysis. The practical outcome of this research is to offer a form of activity that is     feasible, portable, and grounded in sound scientific principles. The scientific goal is to     understand whether the dose of force generated in paralyzed muscle via evoked contractions is     critical to muscle atrophy/hypertrophy molecular pathways, physiologic performance, and     insulin sensitivity. The investigators will administer various doses of muscle force by     manipulating the frequency of electrical stimulation while keeping stimulation current (i.e.     muscle fiber recruitment) constant. Interestingly, no previous study has examined the dose of     muscle force necessary to trigger adaptations in protein synthesis/degradation pathways. The     investigators wish to discover the most effective method to maintain the molecular and     physiologic properties of paralyzed muscle. The investigators believe such a method will be     in urgent demand as a co-intervention with pharmaceutical strategies in post-SCI     rehabilitation.   "
247792|NCT01093027|"     To determine the effects of upper limb forearm cooling on Essential Tremor upper limb tremor     using a more practical method of limb cooling through a forearm cold pack.   "
247793|NCT01093040|"     To assess the safety of the administration of the drug (CAT-354) in healthy Japanese     subjects.   "
247794|NCT01093053|"     The purpose of this study is to determine whether participation in mind-body skills groups by     veterans who have experienced a stressful war-related situation and have symptoms of     posttraumatic stress disorder (PTSD), will improve symptoms of PTSD, depression and anxiety,     reduce anger, improve quality of life, quality of sleep and result in posttraumatic growth (a     positive change that people can experience when they have been in a traumatic situation).   "
247795|NCT01093066|"     Radical cystectomy is the treatment of choice for bladder infiltrative urothelium carcinoma.     But the removal of the bladder reservoir has a major impact of the Quality of life.     Neoadjuvant chemotherapy has been shown to be associated with an absolute 5% survival     benefit. Two monocentric studies suggest that this neoadjuvant chemotherapy could be used in     combination with an optimal transurethral bladder resection, in a strategy of bladder     preservation, provided a complete response being obtained (about 50% in every trial using     neoadjuvant MVAC protocol before a radical cystectomy). In those both studies with patients     T2 to T4, the 5 years overall survival is above 65%, with more than 40% bladder preservation     rate at 5 years.      The feasibility and the efficacy of such an attitude in a multicentric trail using the most     active regimen (in term of complete response in metastatic patients) is unknown. The chosen     regimen is therefore the intensified MVAC which allows, with the use of G-CSF, to double the     dose-intensity of Adriamycin and Cisplatinum, and to decrease by 30% the methotrexate and     vinblastine dose-intensity.      The efficacy and safety confirmation of such an approach could lead to consider it in     patients motivated to retain a functional bladder.   "
247796|NCT01093079|"     Partial Nephrectomy is the standard care for small (<4 cm) renal tumors. Despite the     expanding use of laparoscopic approach, debate exist regarding the short and long term     outcomes compared to the open approach. Our goal is to perform a prospective randomized trial     to compare these methods   "
247797|NCT01093092|"     This phase I trial studies the side effects and best dose of calcitriol when given with     cisplatin and gemcitabine hydrochloride in treating patients with advanced solid tumors that     cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin and gemcitabine     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Calcitriol may stop the growth of tumor cells by     blocking blood flow to the tumor. Calcitriol may also help cisplatin and gemcitabine     hydrochloride kill more tumor cells by making them more sensitive to the drug.   "
247798|NCT01093105|"     The objective of this study is to evaluate the natural history of disease progression in     infants with globoid cell leukodystrophy (GLD).   "
247799|NCT01093118|"     The purpose of this study is to determine if a local treatment is effective for the treatment     of toenail fungus (distal subungual onychomycosis).   "
247800|NCT01093131|"     The increased risk for contrast-induced nephropathy (CIN) in patients with chronic kidney     disease (CKD) undergoing coronary angiography (CAG) has been established. Current and     historical data on CIN prevention strategies have shown wide variation with respect to the     optimal type, route and timing of these therapies. We investigate the role for oral hydration     and/or oral sodium bicarbonate administration compared to intravenous hydration and/or sodium     bicarbonate in patients with CKD undergoing CAG.   "
247801|NCT01093144|"     Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of     delivery(normal vaginal delivery/instrumental delivery/Caesarean section.   "
247802|NCT01093157|"     Membranous Nephropathy (MN) is an immune-mediated kidney disease that affects the glomerulus     or the filter that removes toxins from the blood. Damage to the membrane that separates blood     from urine results in loss of protein into the urine (proteinuria) and in some cases loss of     kidney function.There is no standard specific treatment for MN.      ACTH has a pronounced lipid-lowering effect in healthy individuals, in steroid-treated     patients with renal disease and in hemodialysis patients Some studies suggest that prolonged     synthetic ACTH therapy may represent an effective therapy in patients with idiopathic MN,     more extensive randomized studies with longer follow-up are needed before therapeutic     recommendations can be made.      We propose to do a pilot study to test the hypothesis that biologic ACTH, a slow-release     formulation of corticotropin extracted from porcine pituitary glands (H.P. Acthar gel) will     be effective in reducing proteinuria and improving lipid profile in patients with idiopathic     MN.   "
247803|NCT01093170|"     This is a non-randomized, open-label, dose-escalating Phase Ia study performed at a single     center designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of     intravitreous administration of RNA-144101 in patients with geographic atrophy (GA).   "
248257|NCT01105039|"     Pain after laparoscopic groin hernia repair consist of different pain components (overall     pain, shoulder pain, incisional pain and visceral pain). Thus it is important to find out     which of these pain components that is most severe, so intervention can be targeted.   "
247805|NCT01093196|"     This is a multicenter, randomized, controlled, 3 arm parallel group study designed to     evaluate the efficacy and safety of three all-oral combinations: lenalidomide with     dexamethasone (Rd) in comparison with lenalidomide in association with MP (MPR) and     lenalidomide in association with cyclophosphamide - prednisone (CPR) in newly diagnosed     symptomatic MM patients. This protocol also provides a substudy designed to observe     asymptomatic patients excluded to the protocol that in any case could be inserted in the     study.   "
247806|NCT01093209|"     The purpose of this study is to determine the efficacy of the interferential laser therapy in     the wrist and hand pain and disability reduction and force improvement in the carpal tunnel     syndrome. Subjects are patients diagnosed of carpal tunnel syndrome who have been prescribed     laser therapy. Settings: Ramon y Cajal Hospital. Department of Rehabilitation. Physical     therapy unit. Electrotherapy section. Occupational Therapy. Department of Neurology.   "
247807|NCT01093222|"     This phase II trial is studying how well giving sorafenib tosylate together with erlotinib     hydrochloride works in treating patients with locally advanced, unresectable, or metastatic     gallbladder cancer or cholangiocarcinoma. Sorafenib tosylate and erlotinib hydrochloride may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by     blocking blood flow to the tumor.   "
247808|NCT01093235|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin     hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. It is not yet known whether giving combination chemotherapy together with     or without bevacizumab is more effective in treating patients with nonmetastatic breast     cancer.      PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy     works compared with giving combination chemotherapy together with bevacizumab in treating     patients with nonmetastatic breast cancer.   "
247809|NCT01093248|"     Opioid abuse is a complex problem, which not only impacts on the affected individuals'     physical and psychological health, but also threatens public security and the productivity of     the society. Further, through needle sharing and sexual contacts, injecting drug users (IDUs)     have become laden with HIV and HIV related health problems, representing a serious public     health threat all over the world. In Taiwan, since the identification of the first     HIV-infected IDU in 1987, the incident cases have continued to increase, reaching a height of     2,461 in 2005. In order to contain the epidemics of HIV among IDUs, and to prevent its spread     to the population in general, the Center for Disease Control (CDC) collaborated with the     Department of Justice to initiate and implement a number of harm reduction programs in 2005.     The fact that opioid addiction is officially treated as a health rather than a legal issue     itself represents a remarkable milestone in Taiwan. Among these harm reduction programs,     including needle and syringe exchange for IDUs as well as substitution treatment approaches     for opioid dependence, methadone maintenance treatment (MMT) perhaps represents the most most     important and most crucial component. Remarkably, in a relatively short time span, more than     60 MMT programs were established, which enrolled more than 15,000 heroin addicts. This     notwithstanding, the overall and differential effectiveness of these MMT service delivery     systems, as well as the characteristics of these programs and the patients that might     contribute toward treatment response or failure remain largely unknown. Such knowledge base     is crucial for establishing standardized and feasible outcome evaluation processes for opioid     addicts receiving MMT programs, as well as for the further improvement of the efficacy and     effectiveness of these programs, in Taiwan.      In order to address some of these issues, this study adopts a multi-site, prospective     clinical follow-up design. It aims at establishing a research network for examining MMT     outcome, developing standardized MMT outcome assessment instruments and procedures, and     identifying predictors of MMT outcome. The findings may contribute to the better     understanding of the characteristics of opioid addicts, the effectiveness of MMT and     remaining service needs for opioid addicts in Taiwan.   "
247810|NCT01093261|"     Traumatic brained injured (TBI) patients frequently suffered from glucocorticoid     insufficiency that is associated with a raise in the rate of pneumonia.      In a placebo-controlled, multi-center, double-blinded trial, treatment of glucocorticoid     insufficiency (hydrocortisone associated with fludrocortisone) will be assessed for     prevention of post trauma pneumonia in a population of severe TBI patients.   "
247811|NCT01093274|"     Patients intended for ambulatory colonoscopy will be randomized into 2 groups   "
247852|NCT01101113|"     This study is designed in order to investigate the effect of cinacalcet in combination with     routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT)     and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with     unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent     National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for     dialysis patients.   "
247853|NCT01101126|"     The purpose of this study is to determine whether disease management program is effective in     preventing acute exacerbations in patients with unstable chronic obstructive pulmonary     disease (COPD) or asthma.   "
247812|NCT01093287|"     In a recent multicenter randomized controlled trial, prolonged administration of low-dose     methylprednisolone (1mg/kg/day) initiated in early acute respiratory distress syndrome was     associated with earlier resolution of pulmonary and extrapulmonary organ dysfunction and     reduction in duration of mechanical ventilation and intensive care unit stay. However,     glucocorticoids may induce serious adverse events and these adverse events might compensate     the positive effect of prolonged methylprednisolone infusion and discourage physicians from     treating acute respiratory distress syndrome patients with glucocorticoids. Early prediction     of responsiveness to prolonged methylprednisolone infusion would be help to decide whether to     continue or not prolonged methylprednisolone infusion and this could reduce the drug related     adverse events. We project to evaluate the predictors of responsiveness to prolonged     methylprednisolone infusion in early acute respiratory distress syndrome .   "
247813|NCT01093300|"     In-stent restenosis (ISR) lesions are considered one of the toughest lesions that     interventional cardiologists encounter in the drug eluting stent (DES) era. The current     consensus in treating ISR is implantation of another DES into the restenosed segment. However     the recent results of paclitaxel-releasing balloon catheter (PRBC) in ISR lesions have been     very encouraging. The aim of HOST-ISR trial is to investigate the efficacy and safety of PRBC     compared with everolimus-eluting stent (EES) in preventing neointimal growth in ISR lesions.     HOST-ISR trial is a multicenter, open-label, prospective, randomized trial to test whether     PRBC is non-inferior to EES in preventing neointimal growth in ISR lesions. It plans to     enroll a total of 264 patients with ISR, randomizing the cohort 1:1 to either PRBC or EES.     The primary endpoint will be in-segment late luminal loss at 9 months angiographical     follow-up.   "
247814|NCT01093313|"     The present study aimed to investigate the efficacy and process of change that occurs in     Attention Training in comparison to an established treatment for social phobia, Cognitive     Therapy. A randomized trial was conducted in which participants were allocated to either six     weeks of Attention Training or Cognitive Therapy. It was hypothesized that both treatments     would be effective in reducing social phobia symptoms, but that Attention Training would work     primarily by reducing levels of self focused attention, while Cognitive Therapy would work     through changes to probability and threat appraisals.   "
247815|NCT01093326|"     This study is an extension to the study AC-058B201 and will investigate the long-term safety,     tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple     sclerosis.   "
247816|NCT01093339|"     The purpose of this study is to determine if sleep deprivation results in increased     esophageal acid exposure in healthy controls and gastroesophageal reflux disease (GERD)     patients.   "
247817|NCT01093352|"     The purpose of this pilot clinical trial is to evaluate whether alveolar-decortication has     the potential to reduce orthodontic treatment time following surgical exposure of palatally     impacted canines.   "
247818|NCT01093365|"     Smokers with schizophrenia have more difficulties quitting smoking than smokers without a     mental disorder. Varenicline (Champix) is a new stop smoking medication with a unique     mechanism of action. It is a nicotine-like drug which is not addictive and not associated     with the health risks of tobacco smoking.      Varenicline (VAR) binds to sites in the brain called nicotine receptors that play an     important role in nicotine dependence. People with schizophrenia have difficulties in     concentrating and remembering. Scientists believe that people with schizophrenia use smoking     to remedy their cognitive problems. We will test VAR to see if it improves cognitive problems     in smokers with schizophrenia in comparison to non-mentally ill smokers to determine whether     people with schizophrenia get direct benefit from this nicotine-like drug. It is hypothesized     that VAR (in comparison to a placebo) will reduce aspects of cognitive impairment in smokers     and nonsmokers with schizophrenia.   "
247819|NCT01093378|"     This case-control multicentric study involving fertile and infertile couples aims at     evaluating the impact on conception rate of nutritional parameters (biologic, clinic,     anthropometric, and food questionnaire).   "
247820|NCT01093391|"     The objective of this study is to evaluate the security issues and efficacy of coronary     stenting Cobalt Chrome covered with sirolimus-eluting Cobalt Chrome platform in patients with     coronary artery lesion.   "
247821|NCT01093404|"     Treatment of myocardial infarction (blood clot in the arteries of the heart) has improved     after introduction of 24/7 balloon angioplasty to open the blocked artery. However, the clot     itself is not routinely removed but recent data in smaller trials indicate that this might     improve recovery and prognosis. In this multicenter study of 5000 patients referred to     Scandinavian hospitals for myocardial infarction the investigators test the hypothesis that     patients randomized to treatment with thrombus aspiration (removing the blood clot by manual     suction) before conventional angioplasty will have a reduced risk of death, fewer     rehospitalisations, fewer new myocardial infarctions, reduced risk of heart failure, better     coronary artery flow after angioplasty and greater reduction of infarct size compared to     patients randomized to conventional angioplasty alone.   "
247822|NCT01093417|"     The purpose of this study is to evaluate how Vitamin D affects endothelial function,     inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).   "
247823|NCT01093430|"     The purpose of this study is to study port symmetry and the incidence of anterior abdominal     wall neuropathy associated with gynaecological surgery.   "
247824|NCT01093443|"     In this prospective study, the investigators would like to show whether ovarian stimulation     with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle,     is possible.   "
247825|NCT01093456|"     Study on the daytime variation of uremic retention solutes and markers of bone-mineral     metabolism in patients with end-stage kidney disease treated with peritoneal dialysis   "
247826|NCT01093469|"     The purpose of this study is to compare the efficacy and cost effectiveness of Aquaphor     Healing Ointment, Atopiclair and EpiCeram as a monotherapy in mild to moderate AD.      The investigators hypothesize that no statistical difference will exist in the efficacy     between an over-the-counter moisturizer, Aquaphor Healing Ointment, compared to prescription     devices Atopiclair and EpiCeram in treating mild to moderate AD. Therefore, Aquaphor will be     most cost-effective than Atopiclair or EpiCeram.   "
247854|NCT01101139|"     This study is designed to investigate, whether Sugammadex improves muscle function after     standard neuromuscular recovery (TOF 0.9) from relaxation with rocuronium.   "
247827|NCT01093482|"     The objective of this study is to obtain a better understanding of the spectrum of use of     mechanical ventilation in intensive care units:        1. Main analysis: To know the all-cause mortality rate in mechanically ventilated patients        2. Secondary analyses:             -  To know the current status of mechanical ventilation in the intensive care unit and               determine the number and percentage of patients who are admitted to an intensive               care unit and require mechanical ventilation.             -  To compare the results with prior data collected in previous observational studies               (1998 and 2004)             -  Non-invasive positive pressure ventilation             -  Weaning             -  Use of adjuvant therapies as steroids or selective digestive decontamination             -  Sedation including prevalence of delirium in mechanically ventilated patients             -  Prediction of the duration of mechanical ventilation             -  Other   "
247855|NCT01101152|"     DVS is the main metabolite of the antidepressant/anxiolytic medication Venlafaxine (Effexor).     Like parent compound, DVS is an antidepressant inhibiting both serotonin (5-HT) and     norepinephrine (NE) reuptake. However, no studies to date describe the in vivo potency of     this drug on monoamines reuptake. Consequently, it appears essential to determine the potency     of DVS in human subjects using a wide dose range in order to determine at which dose(s) it     starts inhibiting 5-HT and NE reuptake. The investigators are interested in learning whether     there is a gender difference in the dose of the study medication at which NE reuptake     inhibition occurs.   "
247856|NCT01101165|"     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (40     mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fasted state.   "
247828|NCT01093495|"     There is little data published concerning the best approach to nasal continuous positive     airway pressure (nCPAP) weaning. Potential complications associated with prolonged nCPAP     therapy include gastric distension, nasal trauma,pneumothorax,agitation and nosocomial     infection. Moreover, Infants on nCPAP may also require more intensive nursing care and the     use of extra equipment. Therefore, minimizing the amount of time that a patient requires CPAP     may be beneficial. On the other hand, removing CPAP too early may lead to complications that     include: increasing apnea, increased oxygen requirement, increased work of breathing, the     need to re-start CPAP, and intubation and mechanical ventilation. Moreover, an experimental     study have demonstrated an improvement in lung growth after the prolonged use of CPAP.      Nasal cannula (NC) flows at 1-2 L/min may also generate a positive pressure in the airway of     preterm infants. The use of NC flow to generate positive airway pressure would minimize many     of the application issues of nCPAP. However, NC systems used in neonates routinely employ gas     that is inadequately warmed and humidified, limiting the use of such flows due to increased     risk of nasal mucosa injury, and possibly increasing the risk for nosocomial infection.      The purpose of this randomized controlled trial is to evaluate the clinical impact of two     methods for weaning preterm infants from nCPAP.   "
247829|NCT01093508|"     The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916     when administered as a single dose   "
247830|NCT01093521|"     The purpose of this research study is to test the pharmacokinetics, safety, and tolerability     of an intravenous infusion of a drug called Ganite (gallium nitrate) in patients with cystic     fibrosis. We want to see this drug is safe and tolerable and to see if high levels of the     drug are found in the sputum.      Funding Source - Food and Drug Administration (FDA) Office of Orphan Products Development     (OOPD)   "
247831|NCT01093534|"     The purpose is to see if solifenacin has any effect on bladder wall thickness and urine     inflammatory marker measurements after 12 weeks of treatment.   "
247832|NCT01093547|"     Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in     non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to     investigate if the use of Extraneal (which is a mixture of high weight glucose polymers),     instead of glucose-based solutions such as Dianeal is going to lower the HOMA index in     non-diabetic CAPD patients.   "
247833|NCT01093560|"     Among 10 premenopausal women with Metabolic Syndrome:      Specific Aim 1: Compare the effects of acute fat feeding on flow mediated dilation (FMD) as     measured by brachial artery reactivity among three fat challenges (saturated fat vs.     monounsaturated fat (MUFA) vs. polyunsaturated fat (PUFA)at 4 hours post feeding. Hypothesis     Saturated fat feeding will impair FMD but MUFA and PUFA feeding will not.      Specific Aim 2: Compare the effects of acute feeding on vascular inflammation as measured by     VCAM and sICAM among three fat challenges at 3 1/2 hours post feeding.      Hypothesis: Saturated fat feeding will increase vascular inflammation but MUFA and PUFA will     not.   "
247834|NCT01093573|"     RATIONALE: Midostaurin may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Midostaurin may help azacitidine kill more cancer cells by making the cancer cells     more sensitive to the drug. PURPOSE: This phase I/II trial is studying the side effects and     best dose of midostaurin when given together with azacitidine and to see how well it works in     treating elderly patients with acute myelogenous leukemia.   "
247835|NCT01093586|"     RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) helps     stop the growth of cancer and abnormal cells and helps stop the patient's immune system from     rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not     exactly match the patient's blood, are infused into the patient they may help the patient's     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil     after transplant may stop this from happening.      PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell     transplant works in treating patients with hematologic malignancies.   "
247836|NCT01100892|"     Cystic Fibrosis (CF) is the most common life-threatening genetic condition affecting     Australian children. As well as repeated lung infections, children with CF develop insulin     deficiency and eventually diabetes. The CF-IDEA trial (Cystic Fibrosis - Insulin Deficiency,     Early Action) will determine whether starting insulin treatment before the onset of diabetes     (earlier than current practice) will improve the health of children with CF by improving body     weight and lung function.   "
247837|NCT01100905|"     Military personnel face intense physical and cognitive demands. Diminished iron status     affects physiologic responses to these challenges. Both cross-sectional and longitudinal     studies indicate a significant decrement in iron status in enlisted female military personnel     immediately following basic combat training (BCT). Decrements in iron status are associated     with diminished cognitive and physical performance, and may affect body composition. The     primary objective of this randomized, placebo controlled study is to assess the utility of an     iron-containing food product for maintaining iron status during BCT. This study will provide     insight into the utility and efficacy of an iron-containing food product for the maintenance     of iron status during military training. Furthermore, it will provide novel scientific data     regarding the relationship between iron status and physical and cognitive performance in     female Soldiers.   "
247857|NCT01101178|"     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80     mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.   "
247858|NCT01101191|"     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80     mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.   "
247859|NCT01101204|"     The study is planned to show whether combined hypolipemic and antidiabetic therapy with     various daily dosages influence the fasting plasma glucose, insulin sensitivity and     proinflammatory cytokines in diabetic and dyslipidemic subjects.   "
247860|NCT01101217|"     The purpose of this study is to study the effect of zinc supplementation in end stage renal     failure on hemocystein level.   "
247838|NCT01100918|"     Currently the main selection tool for Cardiac Resynchronisation Therapy (CRT) is the QRS     duration on the surface echocardiography (ECG) which has been shown to be a poor predictor of     response. We sought to evaluate the use of tissue Doppler (TDI) assessment of dyssynchrony in     prediction of response to CRT.      The hypothesis is that the presence of mechanical dyssynchrony (measured using TDI     echocardiography) successfully identifies heart failure patients who will respond to CRT.     Conversely, the absence of mechanical dyssynchrony is associated with a low/no response to     CRT.      This is a three arm study. Group 1 comprises patients with dyssynchrony on TDI who are     implanted with a biventricular ICD whereas Group 2 patients comprise patients who have no     dyssynchrony. Group 2 patients are randomised 1:1 to either receive a biventricular ICD (2a)     or an ICD (2b). All patients undergo a NYHA class assessment, a cardiopulmonary exercise     test, and an echocardiogram at baseline and at 6 months follow up. Baseline and 6 months     findings will be compared in all three groups.   "
247839|NCT01100931|"     Background:        -  Carboplatin-paclitaxel is a commonly used chemotherapy combination for advanced          non-small-cell lung carcinoma (NSCLC) and other solid tumors. In a randomized clinical          trial, the combination of carboplatin, paclitaxel, and the additional chemotherapy drug          bevacizumab had a better response rate and survival compared to carboplatin and          paclitaxel alone. However, this trial treated only patients with a specific diagnosis          and treatment risks. Further research is needed to determine whether this combination is          useful for other diagnoses.        -  YM155 is a drug that targets a type of chemical often found in cancer cells. It has been          investigated in several phase I and phase II clinical trials, and it has been shown to          be well tolerated and moderately effective in treating advanced NSCLC in patients who          had not responded well to one or two standard treatments.      Objectives:      - To determine the efficacy of the combination of carboplatin, paclitaxel, and YM155 in the     treatment of non-small-cell lung cancer.      Eligibility:      - Individuals 18 years of age and older who have been diagnosed with advanced non-small-cell     lung carcinoma or other solid tumors for which standard therapy is not likely to be     effective.      Design:        -  Before the start of the study, participants will be screened with a medical history,          blood tests, imaging scans of the affected areas, tumor biopsies, and other tests as          directed by the study doctors.        -  Participants will be treated for six 21-day cycles, or 18 weeks of treatment. Each cycle          will include blood tests and imaging studies as required.        -  On day 1 of each cycle, participants will receive an infusion of paclitaxel and          carboplatin, followed by a 4-day infusion of YM155 (through a portable electronic          infusion pump).        -  Participants will have a computed tomography scan or other imaging every other cycle          (approximately every 6 weeks) to determine whether the therapy is affecting the cancer          site.        -  After the sixth cycle, participants will return for follow-up visits at least every 3          months, and will be asked to remain in contact with the researchers to allow further          study of the long-term effects of the treatment.   "
247840|NCT01100944|"     Background:        -  Tumors of the thymus are rare and can be treated with surgery, but it is often difficult          to determine whether a thymic tumor is malignant based on biopsy alone and the long-term          survival rate is less than 50 percent. Because thymic tumors are so rare, most treatment          knowledge comes from a relatively small series of cases, and the choice of treatment          usually depends on the hospital or clinic staff's experience and familiarity with a          given chemotherapy and surgery regimen.        -  Belinostat is an investigational anticancer drug that has not yet been approved by the          Food and Drug Administration for use in any cancer. Researchers are interested in          determining whether belinostat can be combined with conventional chemotherapy to safely          and effectively treat advanced thymic cancer.      Objectives:        -  To determine a safe and tolerable dose of belinostat that can be given in combination          with cisplatin, doxorubicin, and cyclophosphamide.        -  To determine if belinostat (combined with the abovementioned standard chemotherapy          regimen) is effective against thymic cancer cells.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with advanced or recurrent     thymic malignancy that is not considered to be curable with surgery or radiation therapy, and     who have not received previous chemotherapy treatment.      Design:        -  Participants will be screened with a physical exam, blood tests, and imaging studies as          directed by the study researchers.        -  Participants will receive six 21-day cycles (18 weeks) of treatment with belinostat in          combination with cisplatin, doxorubicin, and cyclophosphamide. The treatment will          require continuous infusion over 3 days, and participants will remain in the treatment          center during this time. Participants will have regular blood tests, clinic visits, and          imaging studies during the treatment period.        -  Participants who complete the six treatment cycles with no severe side effects may be          offered the option to continue treatment with belinostat alone.        -  After the 18-week study period, participants will return for regular follow-up exams for          at least 4 weeks, and will be asked to remain in contact with the study researchers once          a year to continue to study long-term effects....   "
247841|NCT01100957|"     The study is in two parts      Part one of the study describes the use of the new single-use flexible video-scope for     intubation of patients with predicted normal airways.      Part two compares the performance of the single-use flexible video-scope with that of a     conventional flexible video-scope for awake intubation of patients with predicted difficult     airways.      The hypothesis is that the new single-use flexible video-scope for intubation performs as     well as the traditional scope.   "
247842|NCT01100970|"     The purpose of this study is to determine whether there is a difference between cortisol     levels in fetal blood of babies who were born while using a unipolar needle opposite to using     a bipolar needle, and compared to the control group (infants who were born in a vaginal     birth).   "
247843|NCT01100996|"     During sepsis and septic shock the immune response can be overwhelming leading to excessive     tissue damage, organ failure and death. Ideally, the inflammatory response is modulated     leading to both adequate protection to invading pathogens as well as limitation of an     exuberant immune response. In the last years, experimental evidence has been accumulating     that enteral administration of lipid-enriched nutrition attenuates inflammation and preserves     organ integrity in several inflammatory models. The current study investigates the     immune-modulating potential of enriched enteral nutrition in a human setting of experimental     endotoxemia.   "
247844|NCT01101009|"     Comparison of the combination of amlodipine with an angiotensin receptor blocker or an     angiotensin converting inhibitor, on central arterial blood pressure in patients with     hypertension and additional risk factors. This is a randomised, double-blind, double-dummy,     multicenter study. The duration of active treatment 24 weeks.   "
247845|NCT01101022|"     The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo     on executive function (self-regulation) behaviors in adults with ADHD who report clinically     significant impairment of executive function behavior in their everyday environment, as     measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version     (BRIEF-A) Global Executive Composite (GEC) T-score.   "
247846|NCT01101035|"     The purpose of this study is to see whether subjects with gout who receive febuxostat or     allopurinol for up to 9 years have a higher rate of serious heart and blood vessel     complications (major cardiovascular events). Examples of major cardiovascular events include     heart attacks, strokes, and angina (chest pain due to narrowing of the blood vessels of the     heart) that need to be treated urgently with a heart operation. The overall duration of the     study is dependent on the number of predefined major cardiovascular events (MACE). The length     of study is expected to be approximately 9 years in order to observe the required 624 MACE.     The length of study participation for each subject will vary due to the event driven study     design.      The purpose of this study is to see if subjects with gout who receive febuxostat or     allopurinol, once daily (QD), have a higher rate of serious heart and blood vessel     complications.   "
247847|NCT01101048|"     The purpose of this study is to assess the safety, tolerability, and potential immune     response of AMG 167 following multiple subcutaneous (SC, injection under the skin) dose     administrations in healthy men and postmenopausal women with low bone mineral density.   "
247861|NCT01101555|"     This study is a randomised, single-blind, placebo-controlled, repeat dose study of     otelixizumab administered subcutaneously in rheumatoid arthritis patients. One cohort will     receive a single dose of adalimumab (HUMIRA, Abbott) as rescue medication to assess     additional concomitant safety and tolerability issues.   "
247862|NCT01101568|"     This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the     effect of repeated doses of GSK1292263 on the pharmacokinetics of rosuvastatin and     simvastatin in healthy adult subjects. Each subject will receive single doses of simvastatin     and rosuvastatin on two occasions, once alone and once following administration of repeated     (BID) doses of GSK1292263.   "
247863|NCT01101581|"     The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two     antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to     a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab     attack different areas on lymphoma cells. Because of this, treatment with the combination may     provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given     alone.   "
247864|NCT01101594|"     This study is a Ph I trial to test the safety of the study drug, hLL1-DOX at different dose     levels in patients with recurrent multiple myeloma. HLL1 is also known as milatuzumab and is     attached to doxorubicin in this clinical trial.   "
247865|NCT01101607|"     Distal forearm fractures are amongst the most frequently encountered orthopedic injuries in     the pediatric emergency department (ED). Immediate closed manipulation and cast     immobilization, is still the mainstay of management. The initial management of non-displaced     or minimally displaced extremity fractures and relocation of uncomplicated joint dislocations     is part of the usual practice of emergency medicine. Although focused training in     fracture-dislocation reduction techniques is a part of the core curriculum of emergency     medicine training programs, there is limited data discussing outcomes following restorative     fracture care by pediatric emergency medicine (PEM)physicians.      The primary objective of this study is to compare length-of-stay and clinical outcomes after     closed manipulation of uncomplicated, isolated, distal forearm fractures, by PEMs to those     after manipulation by pediatric orthopedic surgeons. Our hypothesis is that there is no     difference in emergency department length-of-stay when fracture reduction is performed by a     PEM versus a post graduate year 3 or 4 orthopedic resident. Secondary outcomes that will be     assessed include: loss of reduction needing re-manipulation at follow up, cast related     complications, radiographic and functional healing at 6-8 weeks post injury.   "
247866|NCT01101620|"     The purpose of this study is to investigate if levosimendan improves contractile performance     of the diaphragm in healthy subjects.   "
247867|NCT01101633|"     The aim of the study is to investigate the effects of a low-calorie alginate containing fruit     flavored beverage on appetite and body weight development.   "
247868|NCT01101646|"     The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2     different formulations, assess the effect of food on the pharmacokinetics and assess safety     of rabeprazole sodium in healthy volunteers. Rabeprazole sodium is a drug used to treat     patients with Gastro Esophageal Reflux Disease (GERD). GERD is a condition in which the     esophagus (tube from throat to stomach) becomes irritated or inflamed because of acid backing     up from the stomach.   "
247869|NCT01101659|"     The objective of this study is to investigate whether JNJ-40411813 versus placebo reduces     psychosis-like symptoms, induced by infusion of a low dose of ketamine. Effects of     JNJ-40411813 on ketamine-induced symptoms will be evaluated about 3 hours after a single oral     dose when the concentration of JNJ-40411813 in the blood is at its maximum and up to 24 hours     after dose administration to assess the duration of a potential JNJ-40411813 effect.   "
247870|NCT01101672|"     This study aims to compare the outcomes of patients who undergo single-port laparoscopic     colectomy and conventional laparoscopic colectomy for colonic neoplasia (large polyp not     amenable to endoscopic removal/ cancer) through a randomized controlled trial. After informed     consent, patients will be randomized to have either conventional or single-port laparoscopic     colectomy by a team of surgeons with good experience in laparoscopic colorectal surgery.     Patients' demographic, operative detail and post-operative outcomes including operating time,     blood loss, complications, pain score, analgesic requirement, resumption of gastrointestinal     function and length of hospital stay will be recorded prospectively. The patients will be     blinded to the type of treatment that they have received during the first three days after     operation (post-operative pain and analgesic requirement will be recorded in these period).     Patients will have long term up to record for cancer recurrence and survival.      The results of two groups of patients will be compared scientifically to assess if     single-incision laparoscopic colectomy results in any difference in outcomes when compared to     conventional laparoscopic colectomy.   "
247871|NCT01101685|"     This study aims to improve understanding of how people with low mood and negative feelings     (known as dysphoric) may be different from people with normal mood and feelings     (nondysphoric) when responding to a variety of social and emotional information. The study     will look at the patterns of activity in peoples' brains in situations (presented as a     battery of tests) after treatment with a medicine (escitalopram) or a placebo. The results     from this study will help to gather information about the effectiveness of the various tests     being used in this study in detecting any changes due to treatment with an antidepressant.     Half the volunteers taking part in this study will be dysphoric (mildly depressed) whilst the     other half of volunteers will be healthy volunteers. It is hoped that the results of this     study will provide guidance for assessing effectiveness of new medicines and potentially help     with the treatment of depression.   "
247887|NCT01101893|"     In this study, approximately 16 subjects will receive raltegravir 400mg twice daily for 5     days (Treatment A) followed by a washout period. In Period 2, subjects will receive     GSK2248761 200mg once daily for 5 days (Treatment B). There will be no wash out between     Period 2 and 3. Subjects will then be administered raltegravir 400mg twice daily in     combination with GSK2248761 200mg once daily (Treatment C) for 5 days. Subjects will be     housed in the unit for the duration of the study. Safety evaluations and serial PK samples     will be collected during each treatment period. A follow-up visit will occur 7-14 days after     the last dose of study drug.   "
247888|NCT01101906|"     This is a randomized, placebo-controlled, double-blind phase 2 study of OSI-906 or placebo at     a continuous 150 mg twice daily (BID) dose.   "
247872|NCT01101698|"     Vessel calcification is a recognised cardiovascular morbidity risk factor in patients with     chronic kidney disease (CKD). Recent reports indicate a significant role of Matrix     Gla-protein (MGP) in decreasing calcification processes. MGP is excretion protein whose     mechanism of action is not yet fully explained and which to be activated requires     phosphorylation and carboxylation where cofactor is vitamin K. These observations indicate     that shortage of vitamin K is a significant risk factor for the development of vessel     calcification. Another calcification risk factor in CKD patients are calcium-phosphate     disturbances and insufficiency of vitamin D3 which in physiological concentration stimulates     MGP transcription. The aim of this study is estimation of influence of vitamin K2     administration over the period of 9 months on vessel calcification in 3.- 5. stage CKD     patients.      It is a prospective, randomised double-blind study carried out in parallel groups. 60     patients with CKD (GFR 15-60 ml/min) with calcium score >10 (Agatston scoring system) will be     qualified for the study. On the basis of randomised selection, patients will be divided into     two groups: 30 patients will be given 90 μg vitamin K2 + 10 μg and cholecalciferol 30     patients will be given only 10 μg cholecalciferol. After a 9-month treatment the image     diagnostic will be carried out in order to estimate the degree of vessel calcification.   "
247873|NCT01101711|"     Investigation of the incidence of endocrine dysfunction following subarachnoid hemorrhage     (SAH), and to see if this has a relation to CNS lesions as evaluated by MRI and to common     symptoms after SAH such as general exhaustion, lack of initiative, increased sleep demand and     reduced quality of life.   "
247874|NCT01101724|"     The purpose of this study is to find out if strict rest for 5 days helps children get better     after concussion.   "
247875|NCT01101737|"     The investigators will do a trial in two general practices to see if the introduction of a     blood pressure clinic staffed by a specialist nurse supported by visiting consultant improves     blood pressure control compared to usual care.   "
247876|NCT01101750|"     The purpose of the study is to understand if children with liver and kidney transplants     develop the antibodies from the Gardasil vaccine.      The Gardasil vaccine protects against Human Papilloma Virus (HPV) types 16 and 18, which     cause most types of cancers of the cervix, vagina and vulva. It also protects against Human     Papilloma Virus types 6 and 11, which cause genital warts in some people. Gardasil has been     approved by the Food and Drug Administration and is recommended for girls and women from ages     9-26 for the prevention of some types of cancer of the cervix, vagina and vulva as well as     preventing some types of genital warts. In males that are 9-26 years old, the FDA has     approved its use for prevention of some types of genital warts.      The Gardasil vaccine is made from a virus like particle and does not contain any live virus.     Children with an allergy to yeast should not receive the vaccine since some components of the     vaccine are made from yeast.      People who have undergone organ transplant are at increased risk of of developing genital     warts and cancers related to HPV when compared to the general population. The American     Society of Transplantation and the American Society of Transplant Surgeons recommend the     vaccine for people with transplants.      Studies of other vaccines like Hepatitis B have shown children after transplant have less of     a response to this vaccine and are not immune to the Hepatitis B virus. We are interested in     seeing if your child will form antibodies (immune response) to the Gardasil vaccine.      Your child is being asked to be in the study because he or she is between the ages of 9-17     and has undergone a liver or kidney transplant more than 6 months ago and does not have any     signs of organ rejection.   "
247877|NCT01101763|"     This is a 2-part pilot study in healthy male subjects to evaluate plasma enrichment kinetics     of [13C3,4]-cholesterol (Part I) and to assess the test-retest reproducibility (Part II) of     Reverse Cholesterol Transport (RCT) measurements. The study will determine whether atom     percent enrichment (% APE) at 18 hours can be extrapolated from the steady-state value and     whether the mean difference in repeat Ra measurements is below is a prespecified level.   "
247878|NCT01101776|"     This observational multicentric study is planned to assess the tolerability of Rebif New     Formulation in an Australian clinical setting by the incidence of injection site reactions     (ISRs). The study will allow the comparison of tolerability data with historical data for     both Rebif New and classic formulations, and will do so by using the same pre- specified     preferred terms of treatment emergent adverse events as done in historical studies. In     addition, the study will analyse whether interaction(s) with a nurse impacts tolerability and     the impact of Rebif New Formulation on the patient's Quality of Life.   "
247879|NCT01101789|"     This is a prospective randomized multicenter study which purpose is to determine whether     triclosan-coated sutures for wound closure after lower limb vascular surgery would reduce the     incidence of surgical wound infections.   "
247880|NCT01101802|"     Systemic lupus erythematosus (SLE) is an independent risk factor for atherosclerosis.     Endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow     mediated dilation (FMD) of the brachial artery. The purpose of the study was to measure FMD     in mild, stable SLE patients and look for change in FMD with the immunosuppressant drug     mycophenolate mofetil (MMF).   "
247881|NCT01101815|"     This study will obtain pilot data on the impact oral naltrexone 50 mg/day vs. a     sustained-release naltrexone implant on response to antiretroviral therapy (ART) in opioid     addicted patients beginning ART in St. Petersburg, Russia.   "
247882|NCT01101828|"     The purpose of this study is to compare methods for transporting self-collected swabs for HPV     testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year     old women.   "
247886|NCT01101880|"     This phase II trial is studying how well giving clofarabine and cytarabine together with     filgrastim works in treating patients with newly diagnosed acute myeloid leukemia (AML),     advanced myelodysplastic syndrome (MDS), and/or advanced myeloproliferative neoplasm. Drugs     used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving     the drugs in different doses may kill more cancer cells. Colony stimulating factors, such as     filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood     and may help the immune system recover from the side effects of chemotherapy.   "
247889|NCT01101919|"     This study is designed to evaluate the levels of CP-690,550 in the blood of healthy Chinese     subjects following both single doses and multiple doses of drug.   "
247890|NCT01101932|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics (how the drug effects certain target sites of activity in the body) of     escalating doses of oral PF-04308515 in healthy volunteers for 14 days as well as one oral     dose of a tablet formulation administered for 1 day.   "
247891|NCT01101945|"     The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.   "
247892|NCT01101958|"     Use of the Chartis® Assessment System prior to EBV Treatment   "
247893|NCT01101971|"     Objective: To evaluate the effectiveness of a web based learning module in the preparation of     medical students to undertake a first female pelvic exam.      Background: Bryden Magee (Meds 2010) under the supervision of Robert Reid, M.D., created an     educational DVD © 2009 that gives a step-by-step approach to the pelvic exam utilizing real     patient video clips and illustrations. Endorsed by the Association of Professors of     Obstetrics and Gynaecology of Canada (APOG), this educational innovation has been shown to     improve both knowledge and confidence in medical students learning these skills (Magee 2009).     The video content is accessible to all Queen's faculty and students affiliated with the     School of Medicine through MEdTech.      Methods: We will introduce medical students to the MEdTech pelvic exam module and use a     comprehensive assessment tool, designed by experienced gynaecologists in our Department, to     measure how well they perform their first exam on female volunteers acting as mock patients.     We plan to recruit 48 students and 4 mock patients.      Outcome: We will evaluate the success rate of students achieving a passing grade of 50%     (12/24) on their first unassisted speculum and bimanual examination after viewing the video     content.   "
247894|NCT01101984|"     Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated     in comparison with sodium hyaluronate ophthalmic solution.   "
247895|NCT01101997|"     This study is being performed to reduce unwanted abdominal fat using a new applicator for the     Zeltiq System.   "
247896|NCT01102010|"     Elderly with hip fractures are often frail and discharged from hospital after few days of     hospitalisation. Hip fracture surgery is often associated with blood loss, where the patient     is at risk of developing anaemia. Low haemoglobin level reduces the body's oxygen transport     which causes impaired functional ability and strain on vital organs. Acute anaemia is worse     tolerated in elderly, than in younger patients. Therefore this study aims to investigate     whether there are effects of an expanded indication for blood transfusion in the frail     elderly.   "
247897|NCT01102023|"     High sodium intake causes hypertension. Various efforts for reducing salt consumption are     proceeding all over the world. Solar salt contains reduced sodium and abundant mineral, such     as calcium, potassium, and magnesium, comparing to ordinary salt. Use of solar salt, instead     of ordinary salt, may have beneficial effects to blood pressure.      The investigators are going to conduct a preliminary study that can support antihypertensive     effect of solar salt intake.   "
247898|NCT01102036|"     The aim of this study is to determine the effect of cultura yoghurt on transit time and     digestive discomfort during 2 weeks of treatment in comparison to placebo in healthy women     and men.   "
247899|NCT01102049|"     Many population studies include food questionnaires (recording the normal food intake or the     food intake of the study day). This is necessary, because diet is an important lifestyle     factor, although food questionnaires are time-consuming and expensive. Moreover,     mis-reporting is a very common problem. We therefore seek for a tool to validate food     protocol.      The hypothesis is to find biochemical marker for animal protein, fruit intake and grape     consumption in urinary metabolic profiles after specific food consumption. Furthermore we     want to specify biomarkers for different animal protein sources, fish and beef.   "
247900|NCT01102062|"     Human urinary metabolic profiling showed to be very successful to elucidate biomarkers linked     to geographic origin and specific food consumption patterns (Holmes and Loo et al.: Human     metabolic phenotype diversity and its association with diet and blood pressure. Nature     2008:1-6). It was possible to identify urinary metabolites directly linked to animal vs.     vegetable protein intake. This is very valuable for future population studies, where diet is     an important lifestyle factor but food questionnaires are time-consuming and expensive.     Moreover, miss-reporting is a very common problem.      Our hypothesis is to find the same biochemical marker for orange juice as we already found in     a preceding nutritional studies where participants recorded orange consumption.   "
247901|NCT01102075|"     The purpose of this study is to determine whether electroacupuncture is effective on waist     circumference in obesity.   "
247902|NCT01102088|"     The goal of this clinical research study is to find the highest tolerable dose of radiation     that can be given in combination with chemotherapy in patients with esophageal cancer that     cannot be removed by surgery.   "
247903|NCT01102101|"     Postherpetic neuralgia (PHN) is often associated with pain and sensory changes and is the     leading type of neuropathic pain in modern clinical pain research. It is characterized by a     variety of sensory patterns, which may be categorized into irritable nociceptor and     impairment of nociceptor. At date, several lines of evidence lead to the assumption, that     mechanical hyperalgesia in PHN is based - at least in part - on central nervous processes of     sensitization.      In animal studies the investigators have discovered a previously unrecognized effect of     opioids, the reversal of long-term potentiation (LTP) at C-fibre synapses, i.e. an     opioid-induced depotentiation. In principle, synaptic depotentiation may be permanent or     transient. In our study the clinically used ultra-short acting MOR agonist remifentanil     normalized synaptic strength after wash-out of the drug. At present it is not known whether     opioid-induced depotentiation can be used to the benefit of pain patients.      The aim is to study the hypothesis, that pain in a group of PHN patients with predominant     mechanical hyperalgesia is reversed by intravenous remifentanil at a plasma target     concentration of 18ng/ml (corresponding to about 0.75 µg/kg/min) for 60 minutes compared with     PHN patients of other sensory types.   "
247904|NCT01102114|"     The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term     abstinence.   "
247963|NCT01102881|"     Dietary fibers have previously been shown to affect laxation and satiety. Due to differences     in structure and physical properties of dietary fibers, these effects may not be consistent     across all fibers. Therefore as new dietary fibers are created or discovered the laxative and     satiating effects should be investigated in order to verify these effects.   "
247905|NCT01102127|"     Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule     assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign     nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity     using sonography, as malignancy is related to stiffness of solid organs. The investigators     have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter.     Consecutive patients will be assessed using US, FNA and elastography; the latter will be     compared with cytology. Specificity, sensitivity, and predictive values will be calculated.   "
247906|NCT01102140|"     This blinded, controlled study will examine the impact of pomegranate polyphenol extract     (POMx, from Pom Wonderful, LLC), 1000mg on cardiomyopathy in subjects with chronic renal     insufficiency.   "
247907|NCT01102153|"     Sudden cardiac death remains one of the major leading causes of death. Therapeutic     hypothermia is a validated standard procedure to avoid or minimize cognitive deficits after     cardiac arrest. To assess the efficiency of different cooling methods and further improve     these methods, the investigators collected blood samples to measure the neuron specific     enolase (NSE) in patients treated with invasive cooling as compared to patients treated with     non-invasive cooling.   "
247908|NCT01102166|"     Background:      Devices used to facilitate mucus mobilization have been target of several controversies and     mainly a few scientific studies that endorse the use of those equipments. According to the     principle of acapella® device, it should be used concomitant with nebulization aiming to     optimize its performance in bronchial hygiene.      Aims: To assess the effect of acapella® device application in the radioaerosol regional     pulmonary deposition through pulmonary scintigraphy in normal subjects.      Materials and method: 10 health individuals, males and mean age of 24,4 ± 2,2 years     participated in this study during the three phases of this research: 1st phase were done with     nebulization through acapella® device, attached in the final branch according to manufacturer     recommendation; in 2nd phase a ¨T¨tube connector were adapted, being nebulizer attached to     the mouthpiece and in 3rd phase nebulization were performance through the mouthpiece as     routinely used in aerosoltherapy.   "
247909|NCT01102179|"     Vitamin D insufficiency and deficiency is common in chronic kidney disease (CKD) patients and     is associated with elevated parathyroid hormone (PTH) concentration and mineral and bone     disorder (MBD). There is also increasing evidence to show that these abnormalities increase     cardiovascular morbidity and mortality in CKD patients. There is a need for early     identification of vitamin D insufficiency/deficiency in CKD patients to prevent its long-term     complications. However, the vitamin D status of CKD patients in Singapore has not been well     described. The purpose of this study is to assess the vitamin D status of predialysis CKD     patients in a tertiary academic teaching hospital in Singapore, and its association with     parameters for MBD. Predialysis patients from the outpatient renal clinic at the National     University Hospital (NUH) will be recruited into this study. Blood samples from the patients     will be collected after an overnight fast to determine their serum 25(OH)D, creatinine,     phosphorus, calcium, albumin and i-PTH concentrations. These parameters will be compared     among patients in various stages of CKD.   "
247910|NCT01102192|"     Although the association between thymic hyperplasia / thymoma and autoimmune myasthenia     gravis has been known for some time, the question of causality remains uncertain. Recent     research findings indicate, however, that especially in myasthenia patients with thymomas a     non-physiological export of naive CD4 + T-cells can take place by the tumour and this could     possibly play an important role in the pathogenesis of myasthenia gravis. The investigators     want to analyse the functionality and specificity of t-cells generated in thymomas as well as     the effect of thymectomy on the immune system.   "
247911|NCT01102205|"     Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in     subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of     levothyroxine therapy on oxidative balance are also not known in hashimoto disease.   "
247912|NCT01102218|"     Chronic kidney disease (CKD) patients have increased levels of inflammation and oxidative     stress, which in turn contribute to anemia and cardiovascular disease.      Pentoxifylline is known to have anti-inflammatory and anti-oxidant properties, and has shown     promise in improving the treatment of patients with anemia. This study will examine the use     of pentoxifylline for the treatment of anemia in chronic kidney disease.   "
247913|NCT01102231|"     Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell     lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising     association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.   "
247914|NCT01102244|"     The purpose of this study is to evaluate the clinical efficacy and safety of Tobradex ST     compared to AzaSite in the treatment of moderate to severe chronic blepharitis.   "
247915|NCT01102257|"     The purpose of this study is to test a protocol investigating the efficacy of omega-3 fatty     acids in treating dry eye disease. The study is termed feasibility because its purpose is     to demonstrate an ability to execute the proposed protocol with compliance at two sites     rather than generate statistically relevant data concerning the safety and efficacy of the     supplement in patients with dry eye disease.   "
247935|NCT01102517|"     The purpose of this study is to establish the effects of VATS lobectomy for early-stage     non-small cell lung cancer.      The aims of this study are:        1. To evaluate the early clinical benefits of VATS lobectomy when compared with the          axillary thoracotomy.        2. To evaluate the late effects of VATS lobectomy on survival and quality of life when          compared with axillary thoracotomy.        3. To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung          cancer.        4. To explore the indication of VATS lobectomy for the lung cancer.   "
247961|NCT01102855|"     Purpose:      The main objective of this study is to determine endomicroscopic features of Crohn´s disease.      Background:      Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the     gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is     based on several histologic features including transmural pattern of inflammation, crypt     abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a     valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an     optical biopsy of the gastrointestinal mucosa during the endoscopic procedure.      Scope:      In patients with Crohn´s disease.   "
247920|NCT01102322|"     In 1967, Ashbaugh et al first described 12 patients with a syndrome characterized by the     acute onset dyspnea, severe hypoxemia, diffuse lung infiltrates on the chest radiography and     decreased lung compliance. Moreover, in 1988, Murray et al proposed a lung injury scoring     system based on the level of positive end-expiratory pressure (PEEP), PaO2-to-FiO2 ratio,     static lung compliance, degree of infiltrates on the chest radiograph, and clinical cause. A     score of 2.5 or greater was considered to be consistent with a diagnosis of ARDS. The current     definition of ARDS was proposed by Bernard et al and the American-European Consensus     Conference in 1994. The criteria of ARDS included: 1) acute onset; 2) a PaO2/FIO2 ratio, or     hypoxia score, of < 200, regardless of positive endexpiratory pressure; 3) bilateral     infiltrates on chest radiograph; and 4) a pulmonary artery occlusion pressure of <18 mm Hg or     the absence of clinical evidence of left atrial hypertension.      However, despite advances in ventilator management, the mortality rate of acute lung injury     and the acute respiratory distress syndrome remains very high (approximately 40 to 50     percent). In 2000, ARDS Network trial compared the effects of 6 versus 12 mL/kg of tidal     volume per predicted body weight (PBW) among 861 patients and noted an overall 22% reduction     in mortality rate, more ventilator-free days, and more organ-failure-free days in the     low-tidal-volume group. Therefore, the current approach to mechanical ventilation of a     patient with ARDS emphasizes the use of lower tidal volumes with lower pressures to avoid     causing lung overdistension and ventilator associated lung injury.      Nevertheless, one year after publication of the ARDSnet trial, Rubenfeld et al noted that     lung-protective ventilation strategies were applied in less than 5% of patients with ARDS or     ALI at a single ARDSnet center. Rubenfeld et al found that common barriers to the initiation     of low tidal volume ventilation include unwillingness to relinquish control of the     ventilator, failure to recognize patients as having ALI/ARDS, and perceived contraindications     to low tidal volume ventilation. Significant barriers to the continuation of low tidal volume     ventilation include concerns regarding patient discomfort and tachypnea or hypercapnia and     acidosis.      In addition, Kalhan et al also evaluated factors associated with the choice of tidal volume     and he reported that underuse of LPV may be related to clinicians' under-recognition of less     severe cases of ALI, and their reserving of low-tidal volume ventilation for more severe     cases, or both. However, the factors such as comorbidity and pathophysiological change     associated with underuse of lung protective ventilation strategy are not clear. The     investigators perform a prospective single-center study to investigate the factors associated     with the use of lung protective ventilation strategy (LPV) in ALI/ARDS patients in ICU.   "
247921|NCT01102335|"     The purpose of this study is to elucidate the influence of anti-hepatitis B virus therapy on     safety and survival of HCC patient after transcatheter arterial chemoembolization.   "
247922|NCT01102348|"     The purpose of this pilot study is to assess the feasibility, acceptability, and safety of a     new feeding protocol, The Enhanced Protein-Energy Provision via the Enteral Route in     Critically Ill Patients: The PEP uP protocol.   "
247923|NCT01102361|"     The objective of the study is to examine the effectiveness and accuracy of the BioXbot in     prostate biopsy as opposed to transrectal biopsy. This evaluation of the efficacy of both the     procedures is based on:        -  Uptake rate        -  Peripheral zone reachability        -  Needling accuracy        -  Procedure execution time        -  Post operative discomfort or trauma experienced by patient        -  Quality and type of tissue sample extracted        -  Adverse and unanticipated side-effects on patient after the procedure and recording any          unexpected reactions   "
247924|NCT01102374|"     This study will test the role of high dose vitamin D supplementation in prevention of acute     respiratory infection in older nursing home residents. The investigators hypothesize that     residents on high dose vitamin D supplementation will have a lower incidence of acute     respiratory infection that those on standard dose vitamin D supplementation.   "
247925|NCT01102387|"     The aim of this study is to determine the efficacy and safety of once daily topical     application of the combinational cream LAS41003 compared to the corresponding mono-substances     in the treatment of candida infections in intertriginous areas at the trunk.   "
247926|NCT01102400|"     The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese     patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma     (expansion part).   "
247927|NCT01102413|"     The study is designed to determine the effects of an investigational drug Monofer in subjects     with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron     deficiency anaemia (IDA).   "
247928|NCT01102426|"     Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients     with relapsed/refractory multiple myeloma.   "
247929|NCT01102439|"     This study will explore the effect of different doses of aspirin on the effects of     double-dose or standard dose clopidogrel.   "
247930|NCT01102452|"     To evaluate the result of PPB-R-203-02 based noodle and commercially available wet noodle on     blood glucose control in 24 patients with diabetes for 2 days.   "
247931|NCT01102465|"     The objective of this study was to prove the bioequivalence of losartan     potassium/hydrochlorothiazide 100/25 mg tablet under fed conditions.   "
247932|NCT01102478|"     The objective of this study was to prove the bioequivalence of Losartan     Potassium/Hydrochlorothiazide 100/25 mg tablet under fasted conditions.   "
247933|NCT01102491|"     The purposes of this study are to document the antiemetic efficacy of multimodal antiemetic     protocol in patient after Total Knee Arthroplasty using regional anesthesia, midazolam &     propofol, hydration & oxygen supplement, preemptive & multimodal contemporary pain management     and to determine whether Ramosetron prophylaxis would provide additional antiemetic effect on     this protocol. We hypothesized that the incidence of Postoperative nausea and vomiting during     multimodal antiemetic protocol would be lower than Apfel's expected postoperative nausea and     vomiting incidence. It was also hypothesized that Ramosetron prophylaxis would provide     additional antiemetic effect.   "
247934|NCT01102504|"     Stroke is the second leading cause of death worldwide. One of the causes of stroke which can     be treated is narrowing of the carotid artery. Currently the only definite treatment option     is surgery or endovascular treatment. All patients not qualified for or awaiting surgery are,     therefore, left with best medical therapy and with a yearly risk of stroke anywhere between     1% - 35% depending on the severity of the disease.      The study will use the properties of a tomato extract containing lycopene. Previously studies     have demonstrated beneficial properties of tomato extracts:        1. It decreases lipid oxidation        2. It decreases DNA damage        3. It has properties that reduce the speed and amount of cell divisions that inflammatory          and smooth muscle cells undergo (both of these cell types contribute to atheroma          formation).      The investigators wish to assess whether long-term food supplementation with a tomato extract     containing lycopene could influence atherosclerotic plaque characteristics. The investigators     will assess this using Magnetic Resonance Imaging of the plaque and transcranial Doppler     ultrasonography for counting the number of blood clots that go to the brain's arteries.     Furthermore the investigators wish to examine the effect of long-term food supplementation     with a tomato extract containing lycopene on blood cholesterol levels and lipid oxidation and     blood markers of inflammation and injury of the inner lining of the arteries.      This will be a single center, double blind, randomised, placebo controlled study.   "
247936|NCT01102530|"     The objective of this research is to conduct focus groups in order to adapt the Diabetes     Prevention Program (DPP) so that it may successfully target women diagnosed with gestational     diabetes (GDM) who are at high risk for developing Type 2 diabetes in the post-partum period.     As this research seeks to gather formative data for a future intervention, the focus groups     will: 1) provide information to maximize participation in the future intervention and 2)     inform the location, content and format of the intervention.      We will be conducting focus groups and informant interviews to determine the DPP     modifications necessary for adapting to the post-partum lifestyles of women with a recent     history of GDM. Subjects will attend a 1 hour focus group or phone interview where they will     be encouraged to respond to the facilitators' questions and to each other's comments on     topics such as: gestational diabetes, healthy eating, exercise, and other type 2 diabetes     prevention related activities. Working with a variety of health care providers, including     endocrinologists, obstetricians and nurse-practitioners, we will identify and enroll up to 60     women total who are either current GDM patients at BWH or have a recent history of GDM who     have delivered at Brigham and Women's Hospital in the last 5 years.   "
247937|NCT01102543|"     The aim of Alizé is to describe a population of premature babies (gestational age (GA) < 32     weeks) in real life situation and the management of RDS.   "
247938|NCT01102556|"     The specific aims of this project are to create a registry, as well as a biospecimen bank for     individuals with pancreatic disease (e.g. pancreatic adenocarcinoma, pancreatitis,     intraductal papillary mucinous neoplasm (IPMN) mucinous cystic neoplasm (MCN), and pancreatic     intraepithelial neoplasia (PanIN) or have been determined to be at high-risk for pancreatic     cancer. Biospecimen can be defined as blood, urine, tissue, stool, or saliva samples.     Therefore, no hypothesis is to be tested. The personal data derived from the registry,     correlated with biological information derived from the biospecimens will allow for future     investigative studies of pancreatic cancer etiology and tumor biology. The long-term goals of     the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer.     It is anticipated that the knowledge derived will ultimately lead to improvements in the     diagnosis, prevention, detection,and treatment of pancreatic cancer.   "
247939|NCT01102569|"     The aim of this study is to determine the frequency of the three most common BRCA1 and BRCA2     genetic mutations that are commonly found in Ashkenazi Jewish patients with pancreatic     cancer. Testing for BRCA1 and BRCA2 mutations in relatives of hereditary pancreatic cancer     patients may have a significant impact; allowing for early screening, treatment, and     resection of pre-malignant tissue or malignant lesions.   "
247940|NCT01102582|"     -  Dementia correlates to decreased cognitive function, and Behavioral and Psychological          Symptoms of Dementia (Neuropsychiatric symptom, BPSD) as well.        -  Neuropsychiatric symptom attributes important role for mortality, mortality, and cause          to enter nursing home.        -  Study on neuropsychiatric symptom in patients with Parkinson's disease has not been          thorough yet, and there even has not been any study done on this in Korea yet.        -  The investigators will study prevalence of neuropsychiatric symptom in PDD patients and          burden of caregiver.   "
247941|NCT01102595|"     In the last 20 years, only temozolomide has obtained indication for the treatment of     High-grade glioma (HGG). Temozolomide during and later radiation therapy has doubled one year     survival and is the standard treatment for glioblastoma. But 30% of glioblastomas receive     only a biopsy as they can't be resected and don't get benefit from this treatment. They and     should be treated immediately after the biopsy to prevent neurological deterioration but in     spite of this approach they often deteriorate neurologically during radiotherapy. . An     effective pre-radiation treatment should improve their prognosis and allow them to complete     concomitant radiotherapy and temozolomide treatment. Bevacizumab in recurrent HGG displays     63% of objective responses when combined with irinotecan. But irinotecan is not the most     active treatment in this disease.      We propose a phase II, two arms, open label, randomized, multicentric study with 2 cycles of     temozolomide before radiation therapy and concomitant temozolomide, in patients with     glioblastoma and 'biopsy-only'. Bevacizumab will be added to one arm.   "
247942|NCT01102608|"     To study the activity and toxicity of a neoadjuvant regimen including high-dose ifosfamide in     combination with radiotherapy, and subsequent surgery, in high-risk soft tissue sarcomas.   "
247943|NCT01102621|"     Hypothesis: Treatment for head and neck tumors often involve methods that affect the auditory     system and cause hearing loss. Neck dissection negatively impacts the lymphatic drainage,     chemotherapy uses ototoxic drugs, radiotherapy affects blood flow and tissue radiation is     toxic to the ear and may lead to hearing losses of various types and degrees.      Objective: To investigate occurrences of hearing loss and complaints among patients with head     and neck tumors who underwent radiotherapy.      Study design: Prospective, case-control study. Setting: Tertiary care center hospital.      Subjects and Methods: 282 subjects were evaluated, 141 with head and neck tumors and 141 as     an age-matched control group. The controls had never undergone oncological treatment that put     their hearing at risk. All subjects underwent audiological evaluation, including the HHIE     questionnaire, pure tone audiometry, speech audiometry and immittance audiometry. The     radiation dose received by the auditory system was calculated based on the percentage of the     external auditory canal included in the radiation field.   "
247944|NCT01102634|"     The study aims to investigate the effect of Acu-TENS on post-exercise blood lactate level and     EPOC   "
247945|NCT01102647|"     The purpose of the study is to examine the effect of plant sterols on cholesterol absorption     and synthesis in people with heterozygous phytosterolemia.   "
247946|NCT01102660|"     PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain     signalling following nerve injury and inflammation. Blocking such mediators may potentially     have a therapeutic benefit by reducing pain.   "
247962|NCT01102868|"     Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist,     leading to paresthesias, numbness and muscle weakness in the hand. Treatment of the condition     often involves surgery.      In this study we wish to se if there is an effect of using intramuscular stimulation (IMS) to     release the tension of nervus medianus in the lower arm. The study will be performed by     randomization to IMS of musculus pronator teres or a control (Scam IMS treatment to the     acupuncture point Li11). The two insertion points are approximately 1cm apart in the lower     arm.   "
247949|NCT01102699|"     Diabetes mellitus is associated with a significant reduction of circulating progenitor cells     (CPCs). These include endothelial progenitor cells (EPCs), which are involved in     cardiovascular homeostasis and repair. A reduction of CPCs in metabolic patients is     associated with an increased risk of future adverse cardiovascular outcomes. Therefore, ways     to active stimulate an increase of CPC levels in diabetes are actively pursued.      Experimental animal studies and preliminary data in humans indicate that a bone marrow defect     is causally related to the low CPC level in diabetes.      Our previous data in rats indicate that diabetes reduces the bone marrow responsiveness to     granulocyte colony-stimulating factor (G-CSF) in terms of progenitor cell mobilization.      In the present study, we aim at investigating bone marrow responsiveness to pharmacological     mobilization of CPC in diabetic patients as compared to non-diabetic subjects.   "
247950|NCT01102712|"     To establish and confirm the safety and clinical utility of BTVA applied unilaterally for     lung volume reduction in patients with upper lobe predominate heterogeneous severe emphysema.   "
247951|NCT01102725|"     The purpose of this study is to determine:        1. What quantity of bacteria is spilled into the abdomen during a colon resection        2. If there is a correlation between the quantity and post-operative infection        3. What intralumenal pressure is generated when testing the colonic anastomosis for air          leak   "
247952|NCT01102738|"     Highly premature infants are susceptible to serious infections such as necrotizing     enterocolitis (NEC) and late-onset blood stream infections (BSIs).      NEC is a poorly understood, potentially life-threatening bowel disorder. It is thought that     bacteria proliferating abnormally in the bowel may play an important part in its cause, but     no single pathogen has yet been identified.      BSIs are commonly caused by gut bacteria. As the highly premature gut is fragile and has     increased permeability, poor motility and decreased immune defences, localised inflammation     caused by abnormal bacterial growth may allow 'bystander' microbes to translocate through the     gut into the blood stream leading to systemic infection.      The investigators will collect daily faecal samples from premature (<32 weeks) infants in the     intensive care unit from the day of birth until they are discharged. By using newly developed     molecular detection techniques the investigators aim to define more precisely than has ever     previously been attempted, all the species of bacteria present in the faeces. This will     enable comparison of the pre-morbid and post-morbid intestinal microbiota (all the bacteria     in the gut) in premature neonates.      In a small proportion of infants who develop NEC, surgery will be required as part of     treatment of the condition. In these infants the investigators will seek consent to collect a     small part of the diseased bowel which has been removed. Similar analysis will be performed     on these samples. The analysis of the tissue samples will give us an indication of how well     the faeces act as a proxy for the intestinal microbiota.      In this ecological study of the evolution of the intestinal microbiota in preterm infants, by     comparing samples from babies who develop NEC or late-onset BSI with those of well babies the     investigators will be able to look for differences characteristic of the conditions. This     information will help aid design of prevention or treatment strategies.   "
247953|NCT01102751|"     We aimed to determine the effect of vitamin D replacement therapy on serum FGF-23     concentrations in vitamin D deficient women and to compare the FGF-23 concentrations of     vitamin D deficient patients with healthy subjects and patients with genetically-determined     hypophosphatemic rickets.   "
247954|NCT01102764|"     The present proposal is to study whether Prolonged Exposure (PE) delivered via Telemedicine     is as effective as PE delivered In Person for Operation Iraqi Freedom (OIF), Operation     Enduring Freedom (OEF) Veterans and Veterans of all theatres, particularly Vietnam era with     Post-Traumatic Stress Disorder (PTSD). ).   "
247955|NCT01102777|"     The purpose of this study is to assess the efficacy of an internet-mediated pedometer based     intervention that is designed to increase walking and improve function among veterans with     chronic obstructive pulmonary disease (COPD). The Specific Aims are: 1) to test the     effectiveness of an automated internet-mediated walking program for veterans with COPD with a     primary outcome of improvement in health-related quality of life at four-months and at one     year in a randomized controlled trial (RCT) with a wait list control. 2) to estimate the     effect of internet-mediated walking program for veterans with COPD on all cause days of     hospitalization over one year following randomization. 3) to compare intervention reach,     participation and satisfaction outcomes between rural and urban veterans among those     randomized to the intervention arm. The long-term objective of this research is to develop,     evaluate and disseminate effective, low-cost interventions that improve quality of life for     veterans, particularly rural veterans, managing complex chronic conditions.   "
247956|NCT01102790|"     The purpose of this study is to determine the HIT-antibody generation without prior     heparin-exposure in patients undergoing orthopedic surgery.   "
247957|NCT01102803|"     The purpose of this study is to investigate the utility of post-session administration of     D-cycloserine to enhance fear extinction in a sample of people with acrophobia who will be     treated with CBT.   "
247958|NCT01102816|"     The purpose of this study is to determine the feasibility, effectiveness and safety of     acupuncture for pain management in hemodialysis patients.   "
247959|NCT01102829|"     The aim of this study is to accurately assess the relationship between knee joint kinematics     and migration of the tibial component of a high congruent, rotating platform total knee     prosthesis by using fluoroscopy synchronised in time and space with a force plate, an     external motion registration system and Electromyography (EMG).   "
247960|NCT01102842|"     Laboratory studies have found that insufficient sleep duration and impaired sleep quality are     associated with disease risk, including obesity, diabetes and heart disease. The limitation     to the laboratory studies is that they are conducted in artificial environments that do not     reflect real-world behavior. Although the epidemiologic studies do reflect habitual behavior,     the vast majority of them rely on self-reported measures of sleep, which are only moderately     correlated with objective measures of sleep.. The next logical step in the examination of     sleep's role in cardiometabolic health is to conduct objective, detailed measures of sleep in     people's homes. This project is a pilot study that will develop ideal methodologies for     recording sleep in the home environment. Because there is currently is a gap between     laboratory models of sleep loss and real world conditions, the ultimate goal of this research     is to expand our work on sleep and cardiometabolic health outside of the laboratory. Given     the strong evidence for a link between impaired and insufficient sleep and increased disease     risk, it is critical that we understand how people sleep in their daily lives and what     factors can impact sleep. This project will record sleep in people's homes using ambulatory     polysomnography recordings and wrist actigraphy.   "
247985|NCT01103167|"     Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical     management for maintaining normovolemia is needed.      The investigators hypothesized that intervention of volume status with the body composition     monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis patients.   "
247964|NCT01102894|"     Research suggests dietary fiber may decrease transit time through the gastrointestinal tract.     Research studies traditionally use radio-opaque markers to determine gastric emptying,     colonic transit, and whole gut transit time. The SmartPill is a single use pill that can be     used to determine gastric emptying, colonic transit, and whole gut transit time without     requiring X-rays or fecal collections. Previous studies have found radio-opaque markers and     the SmartPill detect the similar transit times.      The purpose of this pilot study is to determine if the SmartPill can detect a change in     transit time using a significant dose of dietary fiber.   "
247965|NCT01102907|"     Our objective is to determine whether food form (liquid vs. solid) alters gastric emptying,     satiety, and food intake, when all macronutrients and fiber are controlled. The study     population will include 10 healthy women, who have a normal body mass index. We have chosen     to evaluate only women because this is a small pilot study and one of our endpoints is     gastric emptying. Gastric emptying is known to differ between men and women. Gastric emptying     will be evaluated using the Smartpill technology, satiety will be evaluated using     computerized visual analog scales/questions, and food intake will be measured by providing     subjects with an ad libitum/buffet-style lunch.      Our hypothesis is that our subjects will be less hungry after they eat a solid breakfast     compared to a liquid breakfast. We also hypothesize that our subjects will have a slower     gastric emptying time after they eat the solid meal. Lastly, we think subjects will want to     eat less food at lunch time if they have eaten a solid meal compared to a liquid meal for     breakfast.   "
247966|NCT01102920|"     The primary aim is to study whether a tailored behavioural medicine intervention addressing     physical activity and eating habits have additional effects to continuous positive airways     pressure (CPAP) in patients with moderate or severe obstructive sleep apnea syndrome (OSAS)     combined with obesity. Direct everyday life consequences (see below) of OSAS are studied, as     well as cognitive functions and ventilatory parameters. Long-term benefits will be examined     in terms of quality of life and everyday life activity. Another aim is to study mechanisms of     treatment effects, if any.      The specific goals are:        1. To study changes in OSAS ventilatory parameters following a tailored behavioural          medicine intervention addressing physical activity and eating habits (including CPAP)          compared to regular CPAP-treatment        2. To study immediate and long-term effects on daytime sleepiness, attention and          concentration, everyday life activity, quality of life following a tailored behavioural          medicine intervention addressing physical activity and eating habits (including CPAP)          compared to regular CPAP-treatment        3. To study associations of changes in metabolic parameters and systemic inflammation and          physical activity level and adherence to CPAP-regimen respectively.        4. To identify mediators, moderators, and predictors of treatment effects, if any.   "
247967|NCT01102933|"     The study is an open, single center, observational study at the Cardiology Dept at Uppsala     University Hospital. The number of patients included will be 410. The objectives are to:      Evaluate biomarkers and change of these related to myocardial infarction, during two years     follow-up in an unselected patient population with a recent myocardial infarction.      Evaluate if an early change of biomarkers can be related to death, new myocardial infarction,     and ischemic stroke in the same population after two and five years follow-up.   "
247968|NCT01102946|"     The purpose of this study is to evaluate the effects of panretinal photocoagulation plus     intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic     retinopathy in terms of changes in visual acuity and neovascularization area.   "
247969|NCT01102959|"     The hypothesis of this study focuses on obtaining accurate information on the effectiveness     of photographic educational material on orientation of carbohydrate counting for adolescents     with diabetes.   "
247970|NCT01102972|"     This study is designed to compare the efficacy and safety of simplifying therapy from a     regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a     regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically     suppressed, HIV-1 infected, HLA-B*5701 negative subjects for 48 weeks.   "
247971|NCT01102985|"     The purpose of the study is to evaluate the effect of an aerobic-resistance exercise program     compared to a home based physical activity program on bone mass, body composition, metabolic     risk factors and cardiovascular fitness in women with cancer who have completed therapy.   "
247986|NCT01103180|"     The goal of this study is to examine the effectiveness the selective serotonin reuptake     inhibitor (SSRI) escitalopram (also known by the trade name Lexapro) in reducing desire to     self-harm and actual self-harming among young adults with borderline personality disorder who     are also currently depressed. Subjects will receive either escitalopram or placebo for eight     weeks. During this time subjects will be make weekly visits to see the psychiatrist and     record their thoughts and feelings several times each day using an electronic diary.   "
247972|NCT01102998|"     Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime     sleepiness. However, very little data are available regarding the specific sleep disturbances     of pediatric brain tumor survivors. Children ages 8 to 18 years of age who are at least 5     years from diagnosis and at least 2 years post treatment or observation only for a brain     tumor will be targeted to assess the prevalence of sleep complaints.      The study focuses on the following objectives:        -  To estimate sleep disturbance in a cohort of pediatric brain tumor survivors.        -  Estimate the rates of parent- and self-reported excessive daytime sleepiness in          pediatric brain tumors        -  Estimate the rates of parent-reported sleep-disordered breathing, including snoring and          witnessed apneas, in pediatric brain tumor survivors        -  Estimate the rates of parent- and self-reported behavioral sleep problems, including          nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in          pediatric brain tumor survivors.      The Study focuses on the following secondary objectives:        -  To describe bedtime patterns and sleep hygiene of pediatric brain tumor survivors.        -  Estimate the typical parent- and self-reported weekday sleep duration of pediatric brain          tumor survivors        -  Estimate the typical parent- and self-reported weekend sleep duration of pediatric brain          tumor survivors and if it differs from the weekday sleep duration        -  Estimate the typical parent- and self-reported consistency of sleep hygiene in pediatric          brain tumor survivors   "
248019|NCT01103609|"     The purpose of this study is to determine whether AZD1656 will affect the Pharmacokinetics     and Pharmacodynamics of Warfarin in T2DM patients.   "
247973|NCT01103011|"     The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and     therefore the levodopa area-under-the-concentration-curve values, half-life, and trough     concentrations The study will help determining the safety and tolerability of ND0611 and     determine the pharmacokinetic profile of levodopa following multiple oral dosing of     levodopa/carbidopa (LD/CD) and continuous delivery of ND0611   "
247974|NCT01103024|"     The purpose of the extension study is to provide patients completing the 28-week core study     with an opportunity to receive an additional 22 weeks of continuous treatment.   "
247975|NCT01103037|"     This study will assess the safety and efficacy of QAV680 in patients with mild to moderate     asthma   "
247976|NCT01103050|"     This study will determine the capacity of more frequent dosing of QAV680 to suppress allergic     inflammation. The study will investigate the paradigm of multiple receptor antagonism in     allergic disease by combining QAV680 with a second generation H1 histamine receptor     antagonist to assess possible additive or synergistic anti-allergic effects of the two     compound classes.   "
247977|NCT01103063|"     The primary objective is to establish superiority of AZCQ over SP in protective efficacy for     IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.   "
247978|NCT01103076|"     In this study, the investigators will evaluate whether CD4+ TCM producing effector cytokines     can be distinguished on the basis of their expression of the IL-7 receptor alpha-chain     (CD127). Using CD154 production as a marker of Ag-specific CD4+ T cells, the investigators     will also test the hypothesis that the phenotype and function of TCM are influenced by the     type of Ag they recognize. TCM specific for two cleared protein Ag, tetanus toxoïd (TT) and     hepatitis B surface (HBs), inducing an early stage of CD4+ T cell differentiation will be     compared to TCM specific for cytomegalovirus (CMV), a persistent virus inducing an advanced     stage of CD4+ T cell differentiation.      The primary endpoint is to demonstrate in uremic patients who will begin chronic HD and in     patients already chronically hemodialyzed any improvement in CD4+ T cell function ex vivo and     in vitro. These analyzes will focus on memory T-cell subsets (i.e. Th17 and Tregs population)     using HCO membranes or polyamide dialyzers.      The secondary endpoint is a clinical one, namely, to show any improvement in T cell response     to HB and TT vaccination (blood antibody titers).   "
247979|NCT01103089|"     The purpose of the study is to determine patient characteristics from patients that have used     Iressa for a period of minimal 3 years.   "
247980|NCT01103102|"     The purpose of this study is to explore the dose-response relationship of Iocide oral rinse     in a clinical trial of gingivitis.      Approximately sixty (60) otherwise healthy subjects having gingivitis will be randomized into     the 3-month study to provide 40 total evaluable subjects (10 per group). Each study     participant will have four visits: a screening visit up to 21 days before the beginning of     the trial, a baseline visit at day 1, and visits at weeks 8 and 12. The duration of the     dose/range study will be three months to facilitate compliance and ensure timely completion     of the Phase II study.      Three dose/regimens will be evaluated against a placebo control oral rinse. Indices for     gingivitis, plaque and bleeding will be scored and blood tests will be performed to determine     the effect of the antimicrobial oral rinse on relative levels of biological markers of     inflammation.   "
247981|NCT01103115|"     The purpose of this study is to determine whether Calcium and Vit D supplementation is     effective for improving low bone mass in Girls with Adolescent Idiopathic Scoliosis (AIS).   "
247982|NCT01103128|"     The primary aim of this study is to determine if mutations of BRCA1 and BRCA2 result in     different precancerous pathways to pancreatic ductal adenocarcinoma (PDAC), as suggested in     our validated mouse model. Genomic DNA will be isolated on normal tissue obtained from     patients who underwent pancreatic resection for PDAC, intraductal papillary mucinous neoplasm     (IPMN) or mucinous cystic neoplasm (MCN). Tissue will be examined for the three most common     founder mutations in Ashkenazi Jews. In the cases in which BRCA1 or BRCA2 mutations are     found, heterozygote normal and abnormal tissue will be examined to look for mutations in the     other BRCA1 or BRCA2 allele. The interaction between other cancer causing genes with BRCA1/2     will also be evaluated by comparing the sequences of the other genes in pre-cancerous     lesions.      We hypothesize that BRCA1- and BRCA2-mediated pancreatic ductal adenocarcinoma progresses     through the PanIN route, as seen in both BRCA1 and BRCA2 murine models of pancreatic cancer.     We further hypothesize that BRCA1 mutations may enable an additional pre- neoplastic pathway     through MCN, and that IPMN may embody yet another pre- neoplastic pathway.   "
247983|NCT01103141|"     FEMORIS is a marketing study approved by institutional review boards to compare the rates of     complications found when using either the Micropuncture® needle introducer or a standard     gauge-18 needle to access the groin blood vessels.   "
247984|NCT01103154|"     Carvedilol is shown to be superior to propranolol to reduce the portal pressure. This study     was undertaken to compare the effectiveness and complication rates of nadolol and isosorbide     mononitrate (ISMN) with carvedilol in the prevention of rebleeding from esophageal varices.   "
247987|NCT01103193|"     patients are allocated to one of the two study groups.      In both groups a mixture of 60% nitrous oxide and 40% oxygen is administered through a face     mask. In the first group the patient receives a constant concentration of sevoflurane. In     this group the remifentanil concentration will be injected via an intravenous line in a step     up protocol. In the second group remifentanil is injected in a fixed rate and sevoflurane is     administered in a step up concentration.      During the study, at predefined times, we will assess different levels of sedation (OAA/S     score) and the reaction on tetanic stimulation of the ulnar nerve, insertion of a laryngeal     mask airway and laryngoscopy. In addition heart rate, SpO2 and capnography will be recorded     continuously and non invasive bloodpressure will be recorded using a 1 minute interval time.     Spectral entropy and BIS derived from the frontal EEG will be used to monitor clinical     cerebral drug effect.      The null hypothesis is that remifentanil lowers the concentration of sevoflurane dissolved in     a mixture of 60% nitrous oxide and 40% oxygen to (1) tolerate a specific stimulation and to     (2) obtain a certain electroencephalographic parameter value and vice versa. Additionally the     results of this study will be compared with a former interaction study of the same study     group that did not involve nitrous oxide, in order to depict the shift in the response     surface evoked by nitrous oxide.   "
248020|NCT01103622|"     The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics     (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.   "
247988|NCT01103206|"     The aim of the study is to compare the results of a parathyroid hormone (PTH)suppression test     using a single oral tablet of cinacalcet in two groups of subjects: 1- a group of healthy     adults in whom the results of the test with cinacalcet will be compared with those of the     standardized PTH suppression test with intravenous calcium loading; 2- a group of patients     with proven primary hyperparathyroidism in whom the results of the test with cinacalcet will     be compared with those obtained during the same test, in healthy controls.   "
247989|NCT01103219|"     The main purpose of this study is to evaluate the effect of increased supply of energy,     protein, vitamin A and the long chain polyunsaturated fatty acids docosahexaenoic acid and     arachidonic acid on growth, brain maturation and cognitive function.   "
247990|NCT01103232|"     Previous studies well documented the impact of unilateral training of limb muscle on the     untrained contralateral homologous muscle. The aim of this study is to evaluate whether the     electrical muscle stimulation on the dominant wrist flexors for 6 weeks cause an increase in     the muscle strength of the contralateral wrist extensors in healthy adult men.      Ethical approval was obtained from Institutional Review Board. All participants were     volunteers and provided written informed consent. Among young adult males working in our     hospital, 30 subjects who voluntarily accepted to participate in this study were assessed for     eligibility. Twenty three young-adult healthy males were included in this double-blind     prospective study. These volunteers were randomized into two groups. In Electrical Muscle     Stimulation (EMS) group, electrical muscle stimulation of the right wrist flexor muscles was     applied; in Controls, transcutaneous electrical nerve stimulation was applied. Electrodes     were placed over the flexor aspect of the right forearm in both groups. Electrical     stimulation was applied for thirty sessions (one session a day, five days a week for six     weeks) in both groups by the same researcher. Compex2 (Medicompex SA, Switzerland) was used     for electrical stimulation. Isokinetic torque was measured in the right and left wrist     flexors and extensors before and after trial. Isokinetic torque was measured in the right     (trained) and left (untrained) forearm with the Cybex (Humac 2004/Norm) extremity-testing     system.   "
247991|NCT01103245|"     The purpose of this study is to determine the effects of mineralocorticoid receptor (MR)     antagonism and renin inhibition on glucose metabolism in humans.   "
247992|NCT01103258|"     Varicose vein disease is a common health problem, which causes much discomfort to patients.      Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided     foam sclerotherapy. These are two equally accepted and applied treatments for the same     patient population.      Choice of treatment often depends on the referral preference of the General Practitioner.     Until now data are missing which treatment is more cost effective. The current proposal aims     at comparing the effects, costs and patient preferences between duplex guided foam     sclerotherapy and surgery in the treatment of greater varicose veins.   "
247993|NCT01103271|"     Placebo pills (pills with no active ingredients) have been shown in research studies to     somehow produce self-healing processes. The purpose of this study is to determine whether     people will be willing to enter an open-label non-deceptive placebo treatment for Major     Depressive Disorder (MDD) and whether open-label placebo can be effective for treating MDD in     the context of a supportive physician-patient relationship.   "
247994|NCT01103284|"     This study will look at the treatment effect of DiaPep277 on preservation of beta-cell     function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that     changes the way the immune system behaves, stopping its attack on the beta-cells.      Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10     injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.   "
247995|NCT01103297|"     The purpose of this study is to is to evaluate the postoperative loss of reduction rate in     patients with distal radius fractures treated using the 2.4 mm Variable Angle LCP Two-Column     Volar Distal Radius Plate ®.   "
247996|NCT01103310|"     Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography)     images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or     inflammation.   "
247997|NCT01103323|"     This is a randomized, double-blind, placebo-controlled multi-center phase III study to     evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer     (CRC) who have progressed on/after all approved drugs for CRC   "
247998|NCT01103336|"     Renal hypoxia plays an important role in the development of contrast-induced nephropathy. The     purpose of the PRINCIPLE study is to investigate the effect of pretreatment with intravenous     nicorandil on the incidence of contrast-induced nephropathy in patients with renal     insufficiency undergoing coronary angiography.   "
247999|NCT01103349|"     This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a     double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main     objective is to assess the effect on lung function. The study will also provide data on the     pharmacokinetics of BI 671800.   "
248170|NCT01098006|"     The purpose of this study is to develop and characterize immunological assays on blood     samples.   "
248000|NCT01103362|"     To generate additional long-term safety and efficacy data on flibanserin in premenopausal     women and establish long-term safety and tolerability of flibanserin in naturally     postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior     clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).   "
248001|NCT01103375|"     This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when     given with isotretinoin in treating patients with recurrent malignant glioma. Erlotinib     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Isotretinoin may help cells that are involved in the body's immune response to     work better. Giving erlotinib hydrochloride together with isotretinoin may kill more tumor     cells   "
248002|NCT01103388|"     The goal of this clinical research is to see if Rituxan (rituximab) therapy given after high     dose chemotherapy and transplant of a patients own stem cells will prevent or delay the     return of the lymphoma.   "
248055|NCT01096472|"     The aim of this study is to determine the efficacy and safety of a topical application of the     combinational cream LAS41003 compared to application of its mono-substances after once daily     treatment in patients with inflammatory tinea pedis.   "
248003|NCT01103401|"     This randomized controlled trial compares two regimens of topical therapy:        -  tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day        -  combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four          times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three          times/day.      Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are     evaluated for        -  corneal edema        -  conjunctival hyperemia        -  anterior chamber (Tyndall) reaction.      The investigators purpose was to evaluate the benefit of adding a non-steroid agent to an     antibiotic/steroid combination after uneventful phacoemulsification. Adopting a weekly     follow-up, to gain insight into the optimal duration of postoperative treatment and to     examine whether risk factors for inflammation exist.   "
248004|NCT01103414|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of three dose     levels of Mitoglitazone™ (MSDC-0160) in patients with type 2 diabetes.   "
248005|NCT01103427|"     The purpose of the study is to investigate the effectiveness of a smoking cessation     intervention delivered through a technological web based platform (www.slutta.no) with or     without a supportive SMS function.   "
248006|NCT01103440|"     The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce     ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention     (PCI).   "
248007|NCT01103453|"     The aim of the study is to investigate the feasibility of using a virtual supermarket as an     intervention tool for overcoming deficits in executive function as well as enhancing IADL     performance among persons with Mild Cognitive Impairment. The working hypotheses are that     there will be improvement in executive functions, and the improvement in the executive     functions will result in better performance in Instrumental Activities of Daily Living, both     generally and especially in shopping task   "
248008|NCT01103466|"     The purpose of this study is to evaluate the performance of Atlas (new base plate) on the     degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is     that Atlas will do better than the two comparator products.   "
248009|NCT01103479|"     The purpose of this study is to evaluate the effectiveness of a low literacy, physician and     patient-directed intervention to promote colorectal cancer (CRC) screening among the     medically underserved.   "
248010|NCT01103492|"     This study involves evaluating a procedure in which the study device, the HALO90 Ablation     catheter, is used to heat a thin layer of tissue lining the rectum using radiofrequency (RF)     energy in subjects suffering from radiation proctitis (acute inflammation of the inner lining     of the rectum caused by the side effects of radiation treatments that can lead to bleeding).      In medical procedures, the RF energy used with this device, has been historically used in     shrinking or removing soft-tissue, for surgical cutting, and for stopping bleeding. The     device is cleared by the Food and Drug Administration (FDA) for use in coagulation (to assit     with stoping bleeding and clotting of blood) of tissue within the digestive tract. The device     has been used in areas outside the esophagus (inner lining of the throat), including the     rectum to treat radiation proctitis. The stoppage of bleeding of radiation proctitis, using     the HALO device, may be one method to control the bleeding.      The purpose of this study is to evaluate the effectiveness and record the results of     treatment of radiation proctitis using the HALO device.   "
248011|NCT01103505|"     The overall objective of this two arm randomized clinical trial (RCT) is to determine if home     monitoring using the comprehensive visual field and telemedicine solution based on the     ForeseeHome device in AREDS2 improves detection of progression to choroidal     neovascularization (CNV) when compared with standard care.   "
248012|NCT01103518|"     This is a Phase IV, randomized, double-blind, comparative study of the use of two     preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual     irregularities of hyper-androgenic origin.   "
248013|NCT01103531|"     The purpose of this study is to assess the effects of an aerobic and strength training     exercise program (one that increases the need for oxygen and increases muscle) on the     treatment outcomes of 150 individuals in treatment for methamphetamine dependence at     Cri-Help. The study will determine if a 60-minute exercise program (three times a week) has     an effect (good or bad) on the health and drug use of participants as compared to individuals     not participating in an exercise program.   "
248014|NCT01103544|"     Documentation of data concerning tolerability and efficacy of the intravenous treatment with     vinflunine performed under daily routine conditions in Germany. The trial focusses on     tolerability including the assessment of the usage of anti-emetic and anti-obstipative     concomitant treatment as well as on the efficacy of the treatment.   "
248015|NCT01103557|"     The purpose of this study is to prospectively analyze the incidence of occult lateral neck     metastasis (LNM) and to elucidate the factors that predict LNM in papillary thyroid carcinoma     (PTC) with central neck metastasis (CNM) by performing prophylactic selective lateral neck     dissection (SND).   "
248016|NCT01103570|"     Standard cystic duct cholangiography (CDC) during laparoscopic cholecystectomy can be     difficult, time consuming and bile duct injury may be caused by attempts to cannulate the     cystic duct. Operative cholangiography performed by direct puncture of the gall bladder     fundus or Cholecystocholangiography (CCC) is a valid and easier alternative.   "
248017|NCT01103583|"     The pathogenesis of MS remain elusive, however some studies have linked the disease with     infection by Epstein-Barr virus; therefore the use of drugs with immunosuppressive or     immunomodulating action alone may be less suitable for primary progressive MS.This study will     evaluate treatment with hydroxyurea (HU) in primary progressive MS. Hydroxyurea act by     inhibiting the synthesis of deoxynucleotides essential for viral transcription,HU has     recently been used in combination with antiretroviral drugs in HIV and has been shown to     limit immune activation and suppress viral load by both antiviral and cytostatic activities.     Furthermore has been demonstrated experimentally that HU suppressed the expression of EBV.     For these reasons HU could be useful in primary progressive MS with cytostatic and antiviral     action , confirming the role of EBV in the pathogenesis of MS.   "
248018|NCT01103596|"     The purpose of this study is to evaluate, in patients in at least the second protease     inhibitor (PI) line, the virological failures under Kaletra® and their consequences on     protease and reverse transcriptase genotypes   "
248021|NCT01103635|"     RATIONALE: Monoclonal antibodies, such as tremelimumab and CD40 agonist monoclonal antibody     CP-870,893, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry cancer-killing     substances to them. Giving tremelimumab together with CD 40 agonist monoclonal antibody     CP-870, 893 may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of giving tremelimumab     together with CD40 agonist monoclonal antibody CP-870,893 in treating patients with     metastatic melanoma.   "
248022|NCT01103648|"     Ezetimibe specifically blocks the absorption of dietary and biliary cholesterol and plant     sterols. Synergism of ezetimibe-statin therapy on LDL-cholesterol has been demonstrated, but     data concerning the pleiotropic effects of this combination are controversial. We tested the     hypothesis that the combination of simvastatin and ezetimibe would induce improvement in     inflammatory status, as reflected by leukocyte count and CRP, IL-6 and TNF-a levels. This     open-label trial evaluated whether this combination results in a synergistic effect the     pro-inflammatory status of pre-diabetic subjects. Fifty pre-diabetic subjects were randomly     assigned to one of 2 groups, one receiving ezetimibe (10 mg/d), the other, simvastatin (20     mg/d) for 12 weeks, followed by an additional 12-week period of combined therapy.   "
248023|NCT01103661|"     This is a multi-center, prospective open label, feasibility study evaluating the safety and     efficacy of the combined ablation procedure for the treatment of longstanding persistent     atrial fibrillation.   "
248024|NCT01103674|"     This is a multi-center, prospective, open label, feasibility clinical study,evaluating the     safety and efficacy of the combined ablation procedure for the treatment of symptomatic     paroxysmal atrial fibrillation.   "
248025|NCT01103687|"     The purpose of this study is to evaluate the safety and immune response of an     adenovirus-based HIV vaccine in HIV-uninfected adults.   "
248026|NCT01103700|"     The purpose of the study is to compare the quality of dying and death of terminal cancer     patients from the perspectives of medical staff and main care giver (family). The hypothesis     is that their view points will be different.   "
248027|NCT01103713|"     The study will be conducted in asymptomatic pregnant women with P. falciparum parasitemia.     The subjects will be given 3 day dosing regiment of the fixed-dose combination of     Azithromycin and Chloroquine. Parasitological clearance rate with polymerase chain reaction     data will be evaluated on Day 28 as primary endpoint.   "
248028|NCT01103726|"     We hypothesize that PF-02545920 will increase glucose metabolism in a part of the brain     called the striatum.   "
248029|NCT01103739|"     The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the     pharmacokinetics (PK) of co-administered single dose simvastatin.   "
248030|NCT01103752|"     The aim of this study is to quantify the incidence of postoperative cognitive dysfunction in     the elderly patient (>60y) after total hip or knee replacement surgery. The hypothesis is     that the fast-track methodology with a mean hospital stay less than 3 days will help to     minimize this reduction in memory and concentration.   "
248031|NCT01103765|"     Comparison with use of Intravascular Ultrasound (IVUS) analysis of two methods of     percutaneous coronary interventions (PCI) with drug eluting stent:      After successful drug eluting stent implantation, patients were randomized into two groups:     Group A had no further dilatation, and Group B had additional post-dilatation with a     noncompliant balloon. The investigators performed IVUS analysis in groups A and B just before     randomization and after post-dilatation in group B.   "
248032|NCT01103778|"     The primary objective of this study is to investigate the ability of Velcade® (bortezomib) to     induce complete or partial remission in patients with severe IgA nephropathy.      The secondary objectives are to assess clinical outcomes relating to safety and efficacy,     such as infection, malignancy, preservation of renal function, partial responders, relapse     rate, and to study mechanistic assays to predict remission.   "
248033|NCT01103791|"     This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose     of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety     and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies.   "
248034|NCT01103804|"     The primary objective of the study is to describe the change in GerdQ sum scores, after a     4-week period of systematic treatment with PPIs(using GerdQ questionnaire). The secondary     objectives are: to measure the response at the current treatment after a 4-week period of     systematic treatment and to identify the percentage of patients which require alterations of     their treatment (GerdQ questionnaire)   "
248035|NCT01103817|"     The purpose of this study is to study the role of low vitamin D levels on the health of blood     vessels or vascular function in adolescents and young adults with type 1 diabetes.   "
248036|NCT01103830|"     The aim of such a study is to evaluate the impact of a therapeutic dose of Eurartesim™     compared to Riamet®, after multiple dose administration for 3 days in healthy male and female     subjects on electrocardiographic parameters.   "
248037|NCT01103843|"     -  The purpose of this study is to determine the level of inhibition of platelet activation          of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the          setting of drug eluting coronary stent implantation.        -  In subjects with high residual levels of platelet reactivity after receiving either a          maintenance or loading dose of either clopidogrel or prasugrel, a cross over of          thienopyridine treatment to the alternate medication will occur.        -  The study tests the hypothesis that adequate platelet inhibition will occur in subjects          who have high levels of platelet reactivity and are subsequently switched from          clopidogrel to prasugrel(loading or maintenance dose) without increased episodes of          bleeding or MACE events at discharge and 30 days post Percutaneous Coronary Intervention          (PCI).   "
248038|NCT01103856|"     At Thomas Street Health Center (TSHC), one of the largest outpatient HIV clinics in the     country, we developed a structured, theory-based, Patient Mentor Program to improve retention     in HIV primary care. Many patients with HIV infection hospitalized at Ben Taub General     Hospital (BTGH) do not successfully return to TSHC after discharge from the hospital. The     purpose of this study is to test the efficacy of a patient mentor intervention in a 5-year     randomized, controlled trial in more than 430 socio-economically and racially diverse     HIV-infected patients hospitalized at BTGH. We hypothesize that the intervention will     meaningfully increase retention in HIV primary care after discharge compared to an attention     control.   "
248039|NCT01103882|"     The primary objectives of this clinical study include:        -  Assess the rate of dislocation and fracture of THA using the new (the 4th generation)          ceramic implants.        -  Evaluate the survival rate of THA using the new alumina-zirconia (the 4th generation)          composite ceramic bearing.        -  Investigate the performance of the 4th generation ceramic implants mostly in patients          younger than 50 years.        -  Compare the preoperative and postoperative scores of Harris Hip Score, UCLA Activity          Score and WOMAC.   "
248040|NCT01103895|"     Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in     adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured     before and after cardiopulmonary bypass using a device that employs ultrasound dilution     technology. The ultrasound dilution cardiac output measurements will be validated or compared     with cardiac output measurements made using thermodilution, which is the current gold     standard.   "
248041|NCT01103908|"     Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in     pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output     will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution     technology. At times, cardiac output will be measured during a procedure called modified     ultrafiltration (MUF). The ultrasound dilution cardiac output measurements will be validated     or compared with cardiac output measurements made using other FDA approved techniques and     devices.   "
248042|NCT01103921|"     The purpose of this study is to examine the effects of consumption of sugar-sweetened     beverages on blood triglycerides and cholesterol, cholesterol concentrations, and the body's     sensitivity to insulin.   "
248043|NCT01103934|"     The objectives of this study would be to see if the addition of vitamin D to fluticasone     propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis     compared to fluticasone propionate treatment alone.   "
248044|NCT01103947|"     This study will evaluate the efficiency of the EcoAnesthesia mask and its advantages over the     standard facemask used in our practice. The satisfaction by the anesthesia provider and its     ease of use may change the standard practice in airway management. In addition to these     additional effects on patient safety, the facemask is affordable and may reduce the     environmental burden of anesthesia waste.   "
248045|NCT01103960|"     The primary objectives of this trial is to demonstrate that the fixed-dose combination of     telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing     seated trough diastolic blood pressure (DBP) at 8 weeks.   "
248046|NCT01103973|"     Stress is a primary reason why in vitro fertilization (IVF) patients drop out of treatment,     and it may have a detrimental impact on pregnancy rates, yet there is minimal published     research on the efficacy of structured skills-based psychological interventions with assisted     reproductive technology (ART) patients. The objective of this study is to determine if women     who are randomized to a mind/body (MB) program prior to starting their first IVF cycle will     have higher pregnancy rates than controls (C).      This is a randomized, controlled prospective study conducted at a private     academically-affiliated infertility clinic and includes 143 women ages 40 and below scheduled     to undergo their first IVF cycle. Subjects are randomized via computer generated random     numbers table to a 10 session mind/body program or a control group and followed for two IVF     cycles. The primary outcome measure is clinical pregnancy rate.   "
248047|NCT01103986|"     The purpose of this study is to evaluate the effectiveness of a health literacy/motivational     intervention in a workplace setting. Parents will be taught how to use a child health book to     lessen inappropriate use of physician services and improve parent confidence in their ability     to identify and obtain necessary assistance when their children are ill.   "
248048|NCT01103999|"     Descriptive, prospective, multicenter evaluation of spleen injury treatment in the Languedoc     Roussilon region according to trauma severity, morbi-mortality and length of hospitalization.   "
248049|NCT01104012|"     The purpose of this study is to verify and validate the intrinsic diagnostic value in terms     of sensitivity and specificity of proteomic profiles determined during a pre-study for     discriminating between allergy related asthma and allergy related rhinitis.   "
248050|NCT01096407|"     RATIONALE: Learning about pain in patients with cancer receiving paclitaxel may help plan     treatment and may help patients live more comfortably. Studying samples of urine from     patients with cancer in the laboratory may help doctors identify and learn more about     biomarkers related to muscle and joint pain.      PURPOSE: This phase I trial is studying the role of biomarkers in muscle pain and joint pain     in patients with solid tumors receiving paclitaxel.   "
248051|NCT01096420|"     The aim of this study was to investigate the efficacy and tolerance of acupuncture treatment     compared with pharmacologic treatment in patients with chronic migraines.Besides, the     investigators tested whether the clinical effects of acupuncture in chronic migraine     prophylaxis are mediated by changes of the plasma CGRP (Calcitonin gene-related peptide).   "
248052|NCT01096433|"     The purpose of this study is to evaluate the associations of circadian variations, sleep     architecture, hypertension and prostanoids in the patients with sleep apnea. In addition, the     patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of     CPAP are also evaluated.   "
248053|NCT01096446|"     The purpose of this study is to study the tolerances of Extremely Low Birthweight Infants who     are born at less than 750 grams who are started at a higher infusion rate of intravenous     lipid emulsions (2 gm/kg/day). These infants will be compared with a control group who are at     the standard lipid emulsion infusion rate (0.5 gm/kg/day).      hypothesis:      A. Objectives of this project.      Null Hypothesis: There will not be a significant difference for Extremely Low Birth Weight     Infants (ELBW) <750 grams being able to tolerate a higher infusion rate of Intravenous Fat     Emulsions (IVFE) within the first days of life (days 1-7) as evidenced by maintenance of a     serum triglyceride level of 200 mg/dl or less.      Alternative Hypothesis: There will be a significant difference (p<0.05) for Extremely Low     Birth Weight Infants (ELBW) <750 grams being able to tolerate a higher infusion rate of     Intravenous Fat Emulsions (IVFE) within the first days of life (days 1-7) as evidenced by     maintenance of a serum triglyceride level of 200 mg/dl or less.   "
248054|NCT01096459|"     The goal of this study is to evaluate a surgical procedure (operation) that reroutes lumbar     to sacral nerves in the spinal column to improve the bladder's ability to empty properly in     patients born with Spina Bifida.   "
248056|NCT01096485|"     A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover,     randomized, prospective design was chosen with a washout of 21 days between the two study     periods. Treatment groups were balanced with the same number of male healthy volunteers who     were randomly assigned to the study drug administration sequences.   "
248057|NCT01096498|"     A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover,     randomized, prospective design was chosen with a washout of 21 days between the two study     periods. Treatment groups were balanced with the same number of male healthy volunteers who     were randomly assigned to the study drug administration sequences.   "
248058|NCT01096511|"     This study is a local, prospective, open-label, company-sponsored, non interventional,     multi-center study. Patients documented must suffer from a cIAI and take at least one dose of     Moxifloxacin infusion.The primary objective is to define the types of cIAI infections that     require Moxifloxacin i.v. therapy in China.   "
248059|NCT01096524|"     Determine the efficacy of neuromuscular electrical stimulation (NMES, Kneehab) in promoting     accelerated recovery of quadriceps function in patients recovering from total knee     arthroplasty (TKA) as measured by increases in isometric strength of the knee extensors and     scores in the Timed Up and Go (TUG) test.   "
248060|NCT01096537|"     Background: Occupational exposures are thought to be responsible for 10-15% of new-onset     asthma cases in adults, with disparities across sectors. Because most of the data are derived     from registries and cross-sectional studies, little is known about incidence of occupational     asthma (OA) during the first years after inception of exposure. This study focuses on this     early asthma onset period among young workers in the bakery, pastry making and hairdressing     sectors in order to assess early incidence of OA in these at risk occupations according to     exposure duration, and to identify risk factors of OA.      Methods: This study is a longitudinal retrospective study with a nested case-control to     identify risk factors of OA. The assessment of incidence evolution is made by exploring a     series of promotions (or retrospective cohorts) with increasing duration since at work. The     study population is composed of subjects who graduated between 2001 and 2006 in sectors where     they experience exposure to organic or inorganic allergenic or irritant compounds (with an     objective of 150 subjects by year) and 250 young workers with no specific occupational     exposure.      This study is a descriptive, monocentric, longitudinal and retrospective study with     cross-sectional measurements.   "
248061|NCT01096550|"     The purpose of this study is to compare the effectiveness of different levels of counseling     (intensive outpatient versus standard outpatient) on treatment outcomes for African American     adult patients receiving buprenorphine in 2 formerly drug-free programs.   "
248062|NCT01096563|"     This is a single centre, Double blinded, Randomised, Placebo-controlled, Parallel group study     to access the safety, tolerability, and pharmacokinetics of Inhaled AZD9164 after     administration of single and Multiple Ascending doses in Japanese subjects.   "
248063|NCT01096576|"     This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the     safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue     virus infection whose symptoms began within the 48 hours preceding the first administration     of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally     twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an     out-patient follow-up to week 12. Target sample size is <200   "
248064|NCT01096589|"     Objectives. The primary objective of the study is to assess volume reduction in the treatment     of lymphoedematous legs and arms with compression bandaging.      Secondary objectives:        -  Assessment of safety        -  Quality of life        -  Health economic parameters        -  Slippage        -  Subbandage pressure   "
248065|NCT01096602|"     Acute myelogenous leukemia (AML) arises from leukemia stem cells that are difficult to     eradicate and serve as a reservoir for disease relapse following chemotherapy. A promising     area of investigation is the development of immunotherapeutic approaches that stimulate the     immune system to recognize leukemia stem cells as foreign and eliminate them. The purpose of     this research study is to determine the safety of the Dendritic Cell AML Fusion Vaccine (DC     AML vaccine) after participants have achieved a remission with chemotherapy. In this clinical     trial, patients are treated with a tumor vaccine alone following standard of care     chemotherapy. The DC AML vaccine is an investigational agent that tries to help the immune     system to recognize and fight against cancer cells. It is hoped that DC AML vaccine will     prevent or delay the disease from coming back.   "
251576|NCT01149122|"     The purpose of this study is to determine whether Gemcitabine/Oxaliplatin (GEMOX) with or     without Erlotinib (Tarceva) is effective in the treatment of unresectable, metastatic biliary     tract carcinoma.   "
248066|NCT01096615|"     The aim of the study is to show an improvement of quality of life on the 5th week of product     consumption (probiotic Lactobacillus paracasei LP-33)(as assessed by RQLQ global score) in     subjects with persistent allergic rhinitis currently treated with Loratadine or oral     anti-histaminic treatment.   "
248067|NCT01096628|"     Recent research has confirmed that low back pain (LBP) is a significant health problem not     only for adults, but also for children and adolescents. Given the enormous social and     economic costs associated with LBP, it is critical that attempts be made to decrease the     burden of LBP for patients and society.      The primary aim of this project is to determine the relative clinical effectiveness of 3     months of chiropractic care and supervised exercise versus supervised exercise in 184     adolescents with sub-acute recurrent, or chronic LBP. Relative effectiveness will be     evaluated in the short, intermediate and long term using pain as the primary outcome measure.     Secondary aims are to assess group differences in patient self-reported disability, quality     of life, perceived improvement, satisfaction, activity levels, lumbar dynamic motion, and     trunk muscle endurance. Patients' and caregivers' perceptions of treatment using qualitative     interviews will also be assessed.   "
248074|NCT01096719|"     The purpose of this investigation is to conduct a 12-week pilot study to examine the effect     of three different dietary prescriptions that differ on targeting reducing energy density     (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation,     satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a     12-week behavioral weight loss intervention.   "
249440|NCT01120873|"     To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese     subjects with metabolic syndrome.   "
248068|NCT01096641|"     Postcancer fatigue is a severe and invalidating problem, impairing quality of life. About 20     to 40% of the patients remain fatigued, at least one year after successful cancer treatment.     Fortunately, there is an effective treatment for postcancer fatigue; cognitive behavior     therapy. However, no cause for postcancer fatigue has been identified yet. The aim of the     study is to identify factors that (partly) cause postcancer fatigue to improve the     theoretical understanding of fatigue and to improve the diagnostics of fatigue, predict     therapy outcome, and facilitate other treatment options.      In this study, disease-free fatigued cancer patients, who finished treatment for cancer at     least one year and maximally ten years ago, will be approached for this study. They will be     compared to non-fatigued patients.      First, a baseline assessment will take place. Magnetic resonance imaging of the brains will     be performed to assess brain volume and magnetic resonance spectroscopy will be performed to     measure the concentrations of specific substances in the brains. Changes in the volume of     parts of the brains have been observed in (non-cancer) patients with the chronic fatigue     syndrome (CFS), in comparison with healthy controls. In addition, abnormal concentrations of     specific substances have been observed in patients with CFS compared to healthy controls. To     assess muscle fatigue, a two-minute endurance test of the upper arm will be administered at     maximal voluntary contraction. Next to differences in the brains, CFS patients showed     (central) muscle fatigue. A maximal exercise test on a bicycle will be performed to assess     physical fitness. Physical activity in fatigued cancer survivors is decreased, compared to     healthy controls. It is not known whether physical deconditioning originated during the     cancer treatment is the reason why these patients are still less active. In addition,     patients and controls will wear an actometer for two weeks to register baseline daily     physical activity and for an additional 5 days after the maximal exercise test, to assess the     effect of exercise on the daily physical activity. Finally, patients and controls will     complete standardized questionnaires and will perform neurological/psychological tests, like     a reaction time test and a short time memory task, at baseline.      The results of the non-fatigued and the fatigued patients will be compared at baseline. For     the non-fatigued participants, the study will be finished after the baseline measurements.     The fatigued participants will start with cognitive behavior therapy immediately after the     baseline measurements or after 6 months, depending on the randomization.      At the end of the therapy, after six months, or after 6 months of waiting for cognitive     behavior therapy, a second assessment will take place, comparable to the baseline     measurements. These results will be compared with the baseline situation to analyze the     effect of cognitive behavior therapy on the (possible) causes of postcancer fatigue.   "
248069|NCT01096654|"     Rationale: Primary hyperaldosteronism (PA) is the most frequent form of secondary     hypertension. In PA autonomous hypersecretion of aldosterone by one or both adrenal glands     causes hypertension that is often refractory to treatment. PA is usually caused by either a     unilateral aldosterone-producing (micro)adenoma (APA) or by bilateral adrenal hyperplasia     (BAH). Distinction between APA and BAH is critical since the former is treated with the aim     of cure by adrenalectomy, and the latter by mineralocorticoid receptor antagonists. This     distinction can be made by adrenal vein sampling (AVS), as recommended by The Endocrine     Society 2008 guideline or by CT-scanning, as is common practice in the Netherlands. AVS is     invasive, demands great skill, and is expensive, while CT-scanning is non-invasive, easy and     cheap, but might be less accurate. However, the advantage of AVS has never been demonstrated     in prospective randomized studies. Here we propose to perform a prospective, randomized,     multicenter study that compares effectiveness of AVS with effectiveness of CT-scanning for     the diagnosis of PA subtype.      Objective: To assess the quantity of antihypertensive medication needed in order to normalize     blood pressure in patients who have been managed for PA according to either AVS or CT-scan.     Secondary objectives: to assess potassium, costs of management and quality of life.      Study design: Prospective, randomized trial in a multi-centre setting. Two hundred patients     will be recruited within two years. Follow-up will be one year after (start of) treatment.      Study population: Adult patients with therapy-resistant hypertension, with or without     hypokalemia, caused by PA.      Intervention: Patients will be randomized to undergo either adrenal CT-scanning or AVS (with     pre-AVS adrenal CT-scanning for phlebography). The result of either of these tests will     determine the course of action: adrenalectomy for adenoma or MRAs for bilateral hyperplasia.      Main study parameters/endpoints: The quantity of antihypertensive drugs patients are using to     obtain target blood pressure, expressed in Daily Defined Dosages, is used as the main study     parameter. There is no criterion standard for accuracy of the diagnosis of PA-subtype, but we     assume that if treatment is based on a more accurate diagnosis, treatment is more effective.     The most important secondary endpoints are the costs of the diagnostic course and long-term     medical treatment and the quality of life as assessed by a validated questionnaire.   "
248070|NCT01096667|"     MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational     drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and     hypertension. Participants in the study will receive 1 of 5 treatments for 1 month including     1 treatment with an approved drug - hydrochlorothiazide (HCTZ).   "
248071|NCT01096680|"     This is a double-blind, single center, parallel group, placebo and active comparator,     controlled study to characterize the wake promoting effects of single doses of SPD489 in     healthy adult male undergoing acute sleep deprivation.   "
248072|NCT01096693|"     Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem     with a poor prognosis and the search for novel treatments remains an important area of     research.      Urocortins are proteins that appear to increase blood flow and heart pumping activity. There     has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in     heart failure.      In this study, we will examine the effects and mechanisms of Urocortins 2 & 3 and the     Corticotrophin Releasing Hormone Receptor Type 2 (CRH-R2) receptor (through which urocortins     act) on forearm blood flow and release of natural blood clot dissolving factors in the     forearm circulation of healthy volunteers.      In this study, we will look at the role of the lining of the blood vessel (endothelium) in     response to urocortin types 2 and 3. We hypothesise that urocortins 2 & 3 act via the     endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen     activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a     role in maintaining the normal baseline level of blood flow in forearm arteries. In addition     to the above, we will also look at the effect of temporarily blocking the effect of     urocortins, using a specially designed blocker drug (Astressin 2B).      Utilising the well-established technique of 'forearm venous occlusion plethysmography', we     will be able to focus on the local effects of urocortins on arterial blood flow in forearm     vessels, without affecting this system in the body as a whole.   "
248182|NCT01098162|"     The purpose of this study is to systematically and prospectively collect data from patients     with partial-onset seizures in routine clinical practice setting receiving adjunctive     Vimpat®. The observed population will be only patients with one baseline antiepileptic drug.     Seizure control and tolerability data will be evaluated.   "
248073|NCT01096706|"     Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem     with a poor prognosis and the search for novel treatments remains an important area of     research.      Urocortins are proteins that appear to increase blood flow and heart pumping activity. There     has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in     heart failure.      In this study, we will examine the effects and mechanisms of Urocortins 2 & 3 on forearm     blood flow and release of natural blood clot dissolving factors in the forearm circulation of     healthy volunteers. In particular, we look at the endothelial mechanisms of vasodilatation of     Urocortin 2 and 3.      In this study, we will look at the role of the lining of the blood vessel (endothelium) in     response to urocortin types 2 and 3. We hypothesise that urocortins 2 & 3 act via the     endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen     activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a     role in maintaining the normal baseline level of blood flow in forearm arteries. In addition     to the above, we will also look at the effect of temporarily blocking the effect of     urocortins, using a specially designed blocker drug (Astressin 2B).      Utilising the well-established technique of 'forearm venous occlusion plethysmography', we     will be able to focus on the local effects of urocortins on arterial blood flow in forearm     vessels, without affecting this system in the body as a whole.   "
248075|NCT01096732|"     This clinical trial is looking at the effect of a new drug called GDC-0449 in patients with     cancer of the pancreas. Laboratory studies have shown that this drug blocks a process in     pancreatic cells thought to be involved in cancer development and spread. This process is     called the 'Hedgehog signalling pathway'. As yet, it is unclear whether blocking hedgehog     signalling will directly affect the tumour cells themselves or the surrounding normal tissue.     Understanding this distinction will help improve treatment strategies for pancreatic cancer.     Patients will be offered to participate in this research study if they have localised     pancreatic cancer that can be removed by surgery. In the period between diagnosis and surgery     the investigators do not normally treat patients, however in this trial the investigators     will ask patients to take GDC-0449 during the approximately two weeks until the day of     surgery. All patients that enter this study will have undergone a diagnostic biopsy of the     pancreatic tumour and the investigators will collect a second sample of the tumour at     surgery. The main question of this study is whether the investigators can detect a change in     hedgehog signalling in the normal tumour surrounding tissue. Furthermore the investigators     will look very carefully whether this treatment is safe for patients. All problems before and     after surgery will be carefully documented and the investigators have defined strict rules to     stop the study if the investigators observe serious problems.   "
248076|NCT01096745|"     The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and     S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.   "
248077|NCT01096758|"     Adult patients with phenylketonuria (PKU) at the age around 40 years belong to the first     patients generation with early treatment of the disease. PKU is caused by an inborn error of     the amino acid metabolism and the so far best suitable therapy is an early and strict diet,     which is low in phenylalanine.      Besides an early and continuously treatment in childhood, the nutritional and medical support     during adolescence and adulthood have been suggested to influence the long-term physical     health of adult PKU patients. As many adult PKU patients tend to neglect the necessarily     strict diet, they do not get a balanced diet. For PKU patients some nutrients, which may be     rare in an unbalanced diet, might help to improve health status, physical and neurological     performance and quality of life.      Information about the longitudinal development of the patients status and the influence of     the type of their medical care is not available. In this 5 year follow-up the investigators     aim to study the quality of life and the medical, nutritional and psychological status of     adult PKU patients, in whom corresponding information has already been collected previously.   "
248078|NCT01096771|"     The purpose of this study is to evaluate the effects of nutritional supplementation with     omega-9 olive-oil and omega-6 soybean oil based lipid emulsions in the Acute Respiratory     Distress Syndrome (ARDS). The investigators hypothesize that these specific lipids in     combination will immunomodulate the inflammatory reaction that occurs in the lungs of ARDS     subjects. This concept is known as Pharmaconutrition. These lipids will be given     intravenously so as to assure administration and only as a supplement to enteral nutrition     which all subjects will also receive. The omega-9 will be compared to the omega-6 formulation     which is the only FDA approved formulation of use in the United States since its development     in 1961 by Fresenius-Kabi, Bad Homburg, Germany. The investigators plan to perform a     bronchoscopy with lavage within 24 hours of enrollment, begin the lipid administration and     continue it for 96 hours after which time the investigators will repeat bronchoscopy with     lavage to assess changes. The lipid administration will cease following the second     bronchoscopy. The fluid obtained from lavage combined with serum samples obtained at the time     of bronchoscopy will be analyzed for inflammatory mediators and cell counts. Clinical data     tracing will include but not be limited to: ventilator days, nutritional status, ICU time,     oxygenation and lung compliance, and 30-day mortality.   "
248079|NCT01096784|"     To compare the severity of retinopathy of prematurity (ROP) among treated infants with an     untreated control population, matched for gestational age at birth while confirming the dose     of rhIGF-1/rhIGFBP-3 is safe and efficacious.   "
248080|NCT01096797|"     The purpose of this study is to determine the incidence of pain, emergence delirium and the     combination of those postoperative negative behaviours during the first 15 minutes after     awakening from sevoflurane anesthesia in pre-school children. Additionally this study will     evaluate the relationship between emergence delirium and postoperative pain behaviour after     adenotonsil surgery.   "
248186|NCT01098214|"     To provide rigorous, detailed normative data for diagnostics and comparative studies, to     determine relationships between cytokine levels (and other biomarkers) and clinical data, and     gain further insight into the pro-/anti-inflammatory cytokine profile of normal midtrimester     amniotic fluid.   "
248081|NCT01096810|"     Purpose:      The purpose of this study is to see if TBL 12, which is a blend of Sea Cucumber, Sea Sponge,     Shark Fin, and Sea Urchin (animals that live in the Pacific Ocean) as well as Sargassum (a     plant that lives in the Pacific Ocean), will have effects against asymptomatic multiple     myeloma and to see what the side effects are.      Eligibility:      Several criteria must be met to be eligible for this study, including but not limited to the     following:        -  a diagnosis of asymptomatic multiple myeloma        -  adequate cardiac, liver and kidney function        -  age 18 and older   "
248082|NCT01096823|"     The purpose of this study is to compare a standardized 6 week Iyengar Yoga program (IYP) for     adolescents and young adults with rheumatoid arthritis to a standard care wait-list     condition. In addition to effects on function and pain, this study will explore intervention     effects on disease activity, immune response, HRQOL, functionality, and mood. Results will     shed light on the feasibility and potential efficacy of a novel intervention (Iyengar yoga)     for rheumatoid arthritis symptoms.      The hypotheses are:        1. The IYP will be safe, acceptable and feasible: at least 80% of subjects will complete          the IYP.        2. Following the IYP, participants will show significantly improved disease status, general          functioning, arthritis-functioning and HRQOL relative to controls. The benefits will be          apparent post-treatment and at two-month follow-up.        3. Following the IYP, participants will report significantly improved pain, immune response          and mood compared to controls. These improvements will be evident at both post-treatment          and at two-month follow-up.   "
248101|NCT01097070|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics     (behavior in the body) of bevirimat administered for 15 days to HIV-positive individuals.   "
248083|NCT01096836|"     The purpose of this study was to compare the effects of two different diets (low carbohydrate     - LCD and conventional - CONV) on body composition, strength performance, muscle mass and     biomarkers of health in overweight adults submitted to resistance training (RT). It has been     hypothesized that LCD would produce higher rates of weight loss and that both diets would be     useful to maintain muscle mass and strength and biomarkers of health.   "
248084|NCT01096849|"     Multi-center, multi-national, double-blind, randomized, comparator-controlled study of     plazomicin administered intravenously compared with levofloxacin, a standard approved     intravenous therapy for complicated urinary tract infection (cUTI) and acute pyelonephritis     (AP).   "
248085|NCT01096862|"     The purpose of this study is to explore the efficacy and safety of multiple, escalating doses     of ASP015K when compared to placebo in subjects with moderate to severe plaque psoriasis.   "
248086|NCT01096875|"     Experimental data have demonstrated favourable effects of statins on endothelial progenitor     cell (EPC) mobilization from the bone marrow, and cardiac homing. The purpose of the present     prospective randomized controlled trial is to determine the effects of aggressive     atorvastatin treatment (40 mg daily 2-weeks prior to surgery) on the number of endothelial     progenitor cells (EPCs) after cardiopulmonary bypass by comparing with placebo.   "
248087|NCT01096888|"     The purpose of this study is to provide weight loss interventions for Mothers participating     in the WIC program, using the internet to deliver weight loss materials.   "
248088|NCT01096901|"     This study is investigating the changes in specific hormone levels in women age 30-45 after a     12 week weight loss intervention.   "
248089|NCT01096914|"     The purpose of this study is to prospectively compare percutaneous radiofrequency ablation     (RFA) versus percutaneous laser ablation (LA) for the treatment of small hepatocellular     carcinoma in patients with cirrhosis.   "
248090|NCT01096927|"     Case control studies that randomly assign patients to either surgical or non-surgical     treatment yield a relapse rate of approximately 14% at one year. It would be useful to know     the relapse rate of patients who have, instead, been selected for a given treatment based on     a thorough clinical evaluation, including physical examination and laboratory results (all     characteristics forming the Alvarado Score) as well as radiological exams if needed or deemed     helpful. If this clinical evaluation is useful,the investigators would expect patient     selection to be better than chance, and relapse rate lower than 14%. Once the investigators     have established the utility of this evaluation, the investigators can begin to identify     those components that have predictive value (such as blood chemistry analysis, or CT     findings). This is the first step toward developing an accurate diagnostic-therapeutic     algorithm which will avoid the risks and costs of needless surgery.      This will be a single-cohort prospective interventional study. It will not interfere with the     usual procedures, consisting of clinical examination in the Emergency Department (ED) and     execution of the following exams at the physician's discretion: complete blood count with     differential, C reactive protein, abdominal ultrasound, abdominal CT. Patients admitted to     Emergency Department with Lower Abdominal and suspicion of Acute Appendicitis not needing     immediate surgery, are requested by informed consent to undergo observation and non operative     treatment with antibiotic therapy (Amoxicillin and Clavulanic Acid). The patients by protocol     should not have received any previous antibiotic treatment during the same clinical episode.     Patients not undergoing surgery will be physically examined 5 days later. During this     follow-up visit, the patient will be given information about the study, will be invited to     participate, and will be asked to sign an informed consent form. If the patient is under the     age of 18 years, consent will be obtained from a parent or other legal guardian.      Telephone (or email) follow-ups will be conducted at 15 days, 6 months, and 12 months (see     attached schedule) to monitor the state of the illness.   "
248091|NCT01096940|"     To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.   "
248092|NCT01096953|"     1. It is difficult to offer kids who live in rural areas good psychiatric care. There are          only about 7000 psychiatrists for kids (pediatric psychiatrists) in the entire country.          When adding nurse practitioners who specialize in mental health care for children, there          still are not enough for everyone who needs care. This means either delays in treatment          or no treatment at all by these important specialists. The purpose of this study is to          explore how the investigators might offer psychiatric care to kids who live in rural          areas through the use of telepsychiatry (TP), specifically those with attention          deficit/hyperactivity disorder (ADHD).           TP is a way for a physician to talk to someone in a remote area using a computer. The          investigators will split the subjects into two study groups. As subjects are identified,          they will be assigned a screening number according to a randomization table. The          investigators will use TP for one group and face-to-face (F2F) care for the other group.          The computer will allow the physician to look at and talk with the child and their          parent(s). The investigators would like to know if TP is as good as, or nearly as good          as F2F care, so the only difference in treatment approach between the two groups will be          whether the subject is receiving treatment through TP or F2F care. Treatment is          standardized using a flow chart called the Children's Medication Algorithm Project          (CMAP) algorithm. The CMAP algorithm is a guideline established by a large number of          experts who have agreed on the best approach to treatment based on scientific evidence.          If TP proves as good as F2F care, it would help many parents and their children who do          not live in or near a large city.        2. The investigators will find study subjects when parents seek care at clinics in rural          Oregon. The physicians in those locations will be aware of the study and will tell us          when they think someone needs specialized mental health professional (either a pediatric          psychiatrist or nurse practitioner with extensive experience in pediatric mental          health). The investigators will make sure that ADHD is the right diagnosis using special          exams that have been well-tested to show that they are reliable.        3. The first visit—the intake visit—will probably take about an hour. At that visit, mental          health professional will determine whether or not the patient is a candidate for the          study. If the patient agrees, they will be asked to sign consent and child assent. The          parent and child will then be given an exam that will confirm the diagnosis of ADHD. If          confirmed, subjects will then learn if they have been assigned to the TP group or the          F2F group and will be assigned to the treating mental health professional. In addition          to the DISC, after consent the parent will be given several study instruments to take          home with them. They will take about an hour altogether to complete.           The first visit with the treating mental health professional will take about one hour          and the three following visits will take about 30 minutes each. These visits will be          about six weeks apart. At the third follow-up visit—the final visit—the parents will be          again asked to complete the instruments they completed after consent and will be asked          to complete a brief questionnaire that will give them the opportunity to describe their          satisfaction or dissatisfaction with the treatment and care they received.           Teachers will be asked to complete the Conner's 10-Item Global Index for the subject          twice over the course of the study. The parent of the subject will present the scale to          the teacher and retrieve the scale in a sealed envelope to return to the clinic.        4. The diagnosis for ADHD will be made using an exam called the Diagnostic Interview          Schedule for Children Version IV (DISC IV). This is a 90-minute exam that is done with a          computer that helps you know what questions to ask and helps record the responses. The          parents will also be asked to complete a few instruments and surveys that help us          understand how well treatment is working. The investigators expect these exams to take          about half an hour to complete. They contain questions about the subject's behavior and          are completed by parents, except one brief instrument that the investigators will ask          and teachers to complete before each follow-up visit. These instruments take about 10          minutes each to complete.        5. This is an initial pilot study, so the information collected will mainly offer a          better understanding of whether or not a larger study is possible. The investigators          will look at how many subjects stayed in the study or dropped out and when they dropped          out. The investigators will also look at the exams, scoring them to help us understand          if those who were part of the TP group did as well, or nearly as well, as those in the          F2F group.   "
248093|NCT01096966|"     This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch)     compared to placebo in patients with chronic low back pain.   "
248094|NCT01096979|"     This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction     of subcutaneous abdominal adiposity.   "
248095|NCT01096992|"     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of     bendamustine, combined with fludarabine and rituximab, that can be given to patients who have     CLL that has been treated before.      The goal of Phase 2 of this study is to find out if this drug combination can help to control     the disease. The safety of this drug combination will also be studied.   "
248096|NCT01097005|"     To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients     with Non-tuberculous Mycobacterial Pulmonary Infections.   "
248097|NCT01097018|"     The trial will compare the overall survival of perifosine plus capecitabine to placebo plus     capecitabine in patients with refractory advanced colorectal cancer.   "
248098|NCT01097031|"     Randomized Clinical Trial to evaluate which is the best infusion system of heparin solution     for Keeping the mean invasive blood pressure whether the continuous system and the     intermittent one.   "
248220|NCT01104298|"     The proposed investigation intends to explore if the combination of trabectedin and     doxorubicin in the first line of treatment of advanced sarcomas obtains better results than     doxorubicin monotherapy   "
248099|NCT01097044|"     This is a randomized placebo-controlled study to be conducted in two parallel study arms for     a six month period (three doses). Approximately 10 eligible patients per center will be     enrolled and will receive afamelanotide (16 mg implants) or placebo according to the     following dosing regimen:        -  Group A will be administered afamelanotide implants on Days 0, 60 and 120        -  Group B will be administered placebo implants on Days 0, 60 and 120      To determine eligibility for study inclusion, patients will undergo a screening evaluation 7     to 14 days prior to the administration of the first dose. The number and severity of     phototoxic reactions will be determined Days 60, 120, and 180. Quality of life will be     measured every 7 days, beginning at Day 0 until Day 180. Participants will visit the clinic     on Days 60, 120 and 180 for assessments of adverse events.   "
248100|NCT01097057|"     This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and     etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor     works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous     peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as     rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them     and helps get better autologous stem cell product. Giving colony-stimulating factors, such as     G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so     they can be collected and stored for future autologous transplant.   "
249441|NCT01120886|"     This is a prospective observational study to examine the incidence of cardiac ion     channelopathies in unexplained still births.   "
248104|NCT01097109|"     The study aims to determine if somatic dysfunctions of the pelvis, sacrum and lower lumbar     spine have an effect on weight bearing. Our subjects are young, healthy subjects without     recent soft tissue or osseous injury, a less than predetermined leg length discrepancy or     OMM/chiropractic treatment. Their leg lengths will be measured; weight-bearing will be     measured using a specialized scale and somatic dysfunctions diagnosed to determine if any     correlation exists.   "
248105|NCT01097122|"     This study hypothesize that radius subjecting to mechanical loading may affect excitability     of alpha motor neuron innervating muscle, based on its bone mineral density or bone mineral     content.      A total of 80 voluntaries are planned to include in this study. Vibration will be applied the     right forearm. Muscle electrical activity will be measured on ipsilateral and contralateral     flexor carpi radialis (FCR) muscle at rest as EMGrms by surface electromyography (EMG). The     rest-EMGrms will be measured at before and during vibration. An increase in muscle electrical     activity at rest indicates an increase in motor neuron pool activation. The right distal     radius bone mineral content (BMC) and density will be measured by dual energy X-ray     absorptiometry (DXA).      The right radius bone mineral density (BMD) and BMC will be evaluated by bone densitometer     (GE-LUNAR DPX PRO).      Motor unit potentials will be measured by electromyography at left flexor carpi radialis.     Neurotrac ETS device will be used.   "
248106|NCT01097135|"     Surgical skin complications can be costly and could contribute to extended in-patient stay     following total joint replacement or even the need for re-admission. If efficacy in reducing     the incidence of post-operative wound drainage and, in turn, surgical wound complications can     be demonstrated, it may also reduce the length of hospital stay and the need for revision     surgery or readmission. The aim of this research is to investigate the incidence of     post-operative wound drainage following elective total joint arthroplasty using two surgical     skin preparation protocols.   "
248107|NCT01097148|"     Rationale: Obesity is an increasing health risk worldwide, with the USA recording prevalence     in adults of around 20%. The mean body weight of obese patients is also increasing. One of     the strategies to treat extreme obesity (Body Mass Index (BMI) > 40 kg/m2) is weight-reducing     surgery like laparoscopic gastric banding or gastric bypass. During anaesthesia, morbidly     obese patients are exposed to an increased risk at developing postoperative wound infections,     apnoea and thrombotic events and may be more difficult to intubate. Routinely, amongst     others, cefazolin, morphine, nadroparin and atracurium are administered in standard dosages.     However, it is not known to what extend the pharmacokinetics and/or -dynamics of these drugs     are affected in morbidly obese patients. Therefore, evidence-based dosing schedules for these     drugs in morbidly obese patients should be developed.      Objective: The study is performed in order to develop population pharmacokinetic and/or     pharmacodynamic models of the routinely used drug therapies during bariatric surgery in     morbidly obese patients (BMI > 40 kg/m2): cefazolin, morphine, nadroparin and atracurium.      A covariate analysis will be performed in order to account for variability in pharmacokinetic     and/or pharmacodynamic parameters. This covariate analysis will take into account procedure     and patient bound covariates, with specific interest for body weight as a covariate. Whenever     possible, non-obese patients will be included in the covariate analysis.      The results will be used to develop individualised dosing schemes for routinely used drugs     peri-operatively in morbidly obese patients.      Study design: A randomised, prospective, observational, therapeutic and invasive study.      Study population: Morbidly obese patients with a Body Mass Index > 40 kg/m2 undergoing     laparoscopic banding or gastric bypass surgery, 18-60 years old. A total of 20 patients will     be included in the study.      Intervention (if applicable): All measurements and data collection will take place around     administration of drugs that are given according to routine clinical practice (cefazolin 2     grams for prophylaxis of infections, morphine 10 mg intravenously at the end of surgery, a     patient-controlled analgesia (PCA) pump with morphine for postoperative pain relief and     nadroparin 0,6 ml for trombo-embolic prophylaxis). For muscle relaxation, patients are     randomised to receive one of two generally accepted dosing regimen of atracurium (0.5 mg/kg     based on ideal body weight or 0.5 mg/kg based on total body weight). Peri- and     postoperatively, a maximum amount of 70 ml of blood will be collected from an indwelling     arterial line for measurement of concentrations of cefazolin, morphine, and anti-Xa     (nadroparin). One week after surgery the patient will be checked for thrombosis using     ultrasonography.      Main study parameters/endpoints:      Primary endpoints to evaluate in morbidly obese patients are;        -  pharmacokinetic parameters of cefazolin in blood;        -  pharmacokinetic parameters of morphine and metabolites in blood;        -  time course of anti-factor Xa levels in blood following nadroparin;        -  time course of the pharmacodynamic effect of atracurium.      Secondary endpoints to evaluate in morbidly obese patients are:        -  to compare primary endpoints (obtained in morbidly obese patients) with data of          non-obese patients        -  the occurrence of postoperative wound infections;        -  postoperative pain scores, sedation scores and nausea scores;        -  the occurrence of bleedings or thrombotic events ;        -  required amounts of morphine (PCA);        -  to compare the time course of the pharmacodynamic effect of two different doses of          atracurium.   "
248108|NCT01097161|"     Subjects' utterances were submitted to acoustic analysis before and after the intervention     program applied on prosodic basis.   "
248109|NCT01097174|"     This study is to evaluate the long-term safety, effectiveness and clinical experience of the     CyPass Micro-Stent in patients with glaucoma.   "
248110|NCT01097200|"     Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the     prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be     effective but it requires a long learning curves and is more aggressive. New meshes     techniques seem to be effective, as well, with less learning curve but they are expensive and     there are no randomize studies published.      The investigators aim is to compare both techniques in terms of: anatomical and functional     efficacy, cost, operating time and complications.   "
248111|NCT01097213|"     Forty 18-year-old social drinkers will be selected from the sample tested in specific aim 1     (Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted     Self-administration of Ethanol (CASE); ClinicalTrials.gov identifier: NCT01063166). The     functional magnetic resonance imaging blood-oxygen-level-dependent (fMRI BOLD) activity     related to disinhibition measured with the Stop Signal task will be assessed during a     continuous infusion of alcohol, clamping the arterial Breath Alcohol Concentration (aBAC) at     60 mg% for approximately one hour. It will be examined whether this fMRI BOLD activity is     associated with the initial drinking trajectories and the alcohol consumption at age 18 and     at age 20 identified in specific aim 1. Furthermore, fMRI will be used with the Taylor     Aggression Paradigm to determine which brain areas mediate increased physical aggression     during the same continuous infusion of alcohol as described above. All participants will     undergo an alcohol and a placebo fMRI session.   "
248112|NCT01097226|"     The main purpose of this study is to determine the oral bioavailability of flavanols     (polyphenolic compounds) from apple granules and an apple extract delivered in a water based     beverage at two different doses. We will also investigate the effects of apple flavanols on     nitric oxide production.   "
248183|NCT01098175|"     Given the observations in animal models and the available data in the human our hypothesis is     that peritoneal cavity conditioning (carbon dioxide with 4% of oxygen and 10% of N2O, 100%     humidification at 32°C,) during open surgery, will result in an important decrease in     postoperative peritoneal inflammation, postoperative pain, and will restore bowel transit     faster.   "
248113|NCT01097239|"     This is a single centre pilot trial to establish the feasibility and role of endoluminal HIFU     in patients with locally advanced cancer within the pelvis that is either primary or     recurrent and with all available current therapy inappropriate and/or exhausted.      The aim is to make a preliminary assessment of efficacy & dosage for evaluation in a     randomised controlled trial. Whilst efficacy data are limited in a small feasibility study;     radiological, biochemical and histopathological analysis of the patient and patient     specimens, along with quality of life questionnaires (QoL), will be used to provide     preliminary measures of efficacy in this patient cohort.      These analyses will allow examination of the biochemical, metabolomic and histological     changes associated with HIFU treatment in cancer within the pelvis.   "
248114|NCT01097252|"     Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and     response rates with the weekly cisplatin based chemoradiation in the treatment of     locoregionally advanced cervical cancers.   "
248115|NCT01097265|"     RATIONALE: Diagnostic procedures such as sentinel lymph node mapping may help doctors find     patients who are at risk of developing micrometastases and plan better treatment.      PURPOSE: This randomized phase II/III trial is studying micrometastases in patients with     stage I or stage II localized colon cancer that can be removed by surgery.   "
248116|NCT01097278|"     RATIONALE: Cholecalciferol may prevent breast cancer in premenopausal women.      PURPOSE: This randomized phase II trial is studying how well cholecalciferol works in     preventing breast cancer in premenopausal women.   "
248117|NCT01097304|"     This pilot phase II trial studies how well ursodiol works in treating patients with Barrett     esophagus or cells that look abnormal under a microscope but are not cancer (low-grade     dysplasia). Chemoprevention is the use of certain drugs to keep cancer from forming. The use     of ursodiol may keep cancer for forming in patients with Barrett esophagus or low-grade     dysplasia.   "
248437|NCT01101542|"     This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK     Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as     per the regulations of the Korean Food and Drugs Administration (KFDA).   "
248118|NCT01097317|"     RATIONALE: Drugs used in chemotherapy, such as carboplatin and vinorelbine, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Chemotherapy can lead to a loss of leg muscle strength. Neuromuscular electrical     stimulation may improve muscle strength and quality of life. It is not yet known whether     chemotherapy given together with neuromuscular electrical stimulation is more effective than     chemotherapy alone in treating patients with non-small cell lung cancer.      PURPOSE: This randomized phase II trial is studying first-line chemotherapy given together     with neuromuscular electrical stimulation to see how well it works compared with chemotherapy     alone in treating patients with non-small cell lung cancer.   "
248119|NCT01097330|"     Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring     back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as     ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart beat     when VT occurs, but they do not prevent further dangerous heart rhythms from occurring. This     study is designed to determine the best way to manage patients who have an ICD and who     continue to have episodes of VT. There are two methods for treatment the VT: 1) Ablation, and     2) Medication.      An ablation procedure involves placing a flexible catheter (insulated wire) in the groin area     and threading it into the heart. After the doctor has located the affected area responsible     for the VT, radiofrequency energy is delivered by the power generator through the catheter to     the inside of the heart. The radiofrequency energy ablates (burns) a small area of the heart     tissue thought to cause the VT.      A medication called Amiodarone is an anti-arrhythmic prescribed to prevent abnormal heart     rhythms from recurring.      The purpose of this study is to compare these two different methods for treating VT.     Treatment with ablation and amiodarone are both considered the standard of care for patients     with VT but they have not been compared directly in a study like this before.   "
248120|NCT01097343|"     Loss-of-function mutation of the gene encoding the CYP450 2C19 enzyme has emerged as a likely     determinant of resistance to clopidogrel therapy. The primary hypothesis of the proposed     research is that among patients with confirmed loss-of-function alleles of the CYP2C19 gene,     increasing the maintenance clopidogrel dose from 75 to 150 mg will result in significant     reduction in the rate of measured clopidogrel resistance defined by multiple measures of     platelet function   "
248121|NCT01097356|"     Aim: In this project proposition the investigators would like to examine the effect of immune     modulation by probiotics on the clearance of HPV-infections.      This study provides a model for viral infection but also for cancer precursors. This would be     an excellent model (and the only possible short-term model) to examine an effect on cancer     precursors. Cancer precursors (cytological abnormalities such as L-SIL) are a scientifically     accepted surrogate endpoint for cervical cancer, for example in HPV-vaccine studies.      Research question: Does daily intake of probiotics lead to a better immune-response in     HPV-infected women, i.e. does it facilitate clearance of the virus and/or regression of     cytological lesions?   "
248122|NCT01097369|"     Primary Objective:      To determine the incidence, titer and type of anti-rasburicase antibodies in the context of     hypersensitivity reaction(s) or the loss of uricolytic activity occurring in patients with     relapsed leukemia/lymphoma who have been re-treated with rasburicase and have experienced a     hypersensitivity reaction or loss of uricolytic activity.   "
248123|NCT01097382|"     Primary Objective:      To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration      Secondary Objective:      To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration   "
248124|NCT01097395|"     The purpose of this study is to determine if concentration-controlled ribavirin dosing can     achieve a targeted level of plasma exposures and if it appears safe and effective compared     with standard weight-based ribavirin dosing. Forty, previously treatment-naive participants     with genotype 1 disease will be randomized to receive concentration-guided or standard     weight-based ribavirin. Peginterferon alfa 2a,ribavirin, and telaprevir will be provided     through the study.   "
248125|NCT01097408|"     This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers.   "
248184|NCT01098188|"     This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of     the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell     chronic lymphocytic leukemia who have received at least one prior fludarabine-containing     regimen.   "
248126|NCT01097421|"     This is an open-label, prospective post marketing surveillance study to be performed in     Sweden. Only data of patients idiopathic PD should be documented, in whom the treating     physician plans to initiate a pharmacotherapy with PPX ER independent of this observational     study. The questionnaires (Morisky Medication Adherence Measure, patient preference scale,     CGI-I, PGI-I) will be used to document routine care in a standardized way and thus ensure     high validity of the observational data. As the degree medication adherence of patients is     routinely evaluated by their physicians, as is patient preference and possible symptom     improvement after initiation of a new therapy, the patient questionnaires will be used to     standardise medical routine care and to ensure validity of observational data.   "
248127|NCT01097434|"     The objective of the study is to assess the superiority of the biodegradable polymer based     limus-eluting stent (Nobori®) compared with the permanent polymer based everolimus-eluting     stent (XIENCE V®) regarding absolute percentage of uncovered stent strut segments.   "
248128|NCT01097447|"     To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen     (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by     inducing additional cross-links within or between collagen fibers using UVA light and the     photo- mediator riboflavin. The purpose of this study is to generate data for presentation at     medical meetings and for peer-review publication   "
248129|NCT01097460|"     This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.   "
248130|NCT01097473|"     This controlled study is undertaken to investigate the effects of a long term outpatient     training program on physical fitness and quality of life in elderly asthmatics.   "
248131|NCT01097486|"     The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in     subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical     vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level     anterior cervical discectomy and fusion with anterior cervical plate fixation.   "
248132|NCT01097499|"     Study hypothesis: Low level laser (LED) will reduce initial bone resorption and improve     primary stability of dental implant. It will also reduces post operative pain compared to     patient without treatment      Implant osseointegration depends on many factors including biocompatibility of implant     materials, design, surface, surgical access, patient conditions, biomechanical status, and     lack of primary stability.      Several in vivo and in vitro studies showed the healing effect of low level laser therapy     (LLLT) on bone by decreasing the initial bone resorption postoperatively and increasing the     primary stability of the implant. It has also shown to have an analgesic effect intraorally     when used post intraoral surgical procedures. The exact mechanism is unclear despite the fact     that many hypothesis has been proposed.      In our study, our goal is to present, in a randomized standardized clinical trial, the effect     of LLLT on post operative implant stability assessed by resonance frequency analysis (RFA).     We will assess the subjective measures of postoperative pain using visual analog scale (VAS).   "
248133|NCT01097512|"     In clinical practice and research, combination of anticancer agents is often used to improve     efficacy of treatment. In vitro and in vivo experiments have shown additive-synergistic     anti-tumour effects of AS703569 treatment when combined with gemcitabine. Specifically,     additive-synergistic anti-tumour effects were noticed when the two agents were given     sequentially and not concomitantly i.e. AS703569 given the day before or the day after     gemcitabine. This trial was designed to investigate in parallel two regimens testing     sequential administration of AS703569 either the day after gemcitabine infusion, (Regimen 1)     or the day before (Regimen 2).   "
248134|NCT01097525|"     To determine the effect of two types of wavefront modalities (WFG vs. WFO) and two types of     refractive surgery (PRK vs. LASIK) on visual and military task performance after laser     refractive surgery.   "
248135|NCT01097538|"     This project will evaluate a new therapy for patients with a severe form of MS known as     progressive MS. These patients are severely limited in their ability to walk and function in     everyday life. The exercise therapy we are proposing is a recumbent cross trainer which     allows patients to be seated and move their arms and legs at the same time against resistive     foot pedals and arm levers. The recumbent cross trainer is safe and easy to use for people     with disabilities and is more cost-effective compared with other rehabilitation equipment.     Before the recumbent trainer can become part of mainstream MS therapy, it is important to     determine if it is as effective as other exercise therapies in improving functional     performance and quality of life. In this study we will compare the effects of the recumbent     cross training with supported treadmill walking on functional and psychological outcomes.     Further, since this is a new therapy for progressive MS patients, we also want to determine     if it is safe and enjoyable to use.      We hypothesize that recumbent stepper training will be safe and well-tolerated by progressive     MS patients. Both training interventions will be beneficial in improving walking function and     psychosocial outcomes. Recumbent stepper straining will likely have greater effects on upper     extremity function, while supported treadmill walking will have greater effects on lower     extremity function.   "
248136|NCT01097551|"     The aim of the study is to progress in the understanding of the early retinal vascular and     neural abnormalities in patients with diabetes, using a new device, the Dynamic Vessel     Analyzer. The Dynamic Vessel Analyzer allows to measure the diameter of the retinal vessels     and to assess how it varies in presence of various stimuli. Then, we will be able to assess     if a vascular and/or a neural dysfunction is present early in patient with diabetes.   "
248137|NCT01097564|"     This prospective multicenter cohort study aims to define the clinical, radiological and     mutational spectrum of the disease related to COL4A1 gene.   "
248185|NCT01098201|"     This open-label pilot study will select subjects who are inadequate responders to     methotrexate. These subjects will receive certolizumab subcutaneously on a monthly basis for     six months. The study is attempting to determine the following:        1. Is lymphatic flow altered in the extremities of RA patients with an inflamed knee?        2. Is resolution of synovitis associated with a restoration of lymphatic flow and lymph          node volume following therapy with certolizumab?        3. Can Doppler ultrasound be used to detect and follow alterations of lymph node size?   "
250198|NCT01124825|"     The purpose of this study is to determine whether two new airway devices used during     anesthesia called iGEL™ and KING-LTS-DTM work well and are safe in obese patients. They both     work well in thin patients, but have not been tested in obese patients.   "
248138|NCT01097577|"     Purpose: To compare the efficacy of pregabalin to placebo for postoperative pain control     after photorefractive keratectomy.      Patients: Study subjects will be taken from a standard group of typical candidates for PRK     surgery including active duty and DoD beneficiaries. Prior to being approached for the study,     all patients will have had a previous desire for surgery and had a pre-operative evaluation     indicating healthy ocular status.      Methods: Patients scheduled for PRK surgery will be briefed on the purpose of the study and     invited to participate at the preoperative appointment. After the consent process, patients     will be randomized in a 1:1 fashion to receive either oral pregabalin 75mg BID or placebo for     pain control, in addition to the standard care treatment of as needed Percocet and tetracaine     ophthalmic drops. Subjects will be evaluated daily for 4 days post-operatively for subjective     pain assessment, adverse drug events and compliance, use of concomitant medications as well     as monitoring of healing time. Quality of life will be measured at baseline and post-op day 2     when the peak of pain is anticipated. Analysis will be performed to detect an approximate 10%     improvement in pain scores. Secondary outcomes will include measuring healing time, quality     of life and use of rescue medications.   "
248139|NCT01097590|"     The purpose of this study is to determine whether a treatment of a novel leukapheresis column     is safe and effective in patients with moderate to severe ulcerative colitis.   "
248140|NCT01097603|"     To validate accuracy of the readings of noninvasive blood pressure (NIBP) module with     sphygmomanometer as per the requirements of AAMI SP10:2002. This study is for adult and     pediatric population.   "
248141|NCT01097616|"     This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to     placebo in improving insomnia as measured by change from baseline in: subjective total sleep     time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of     persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may     participate in an optional 3-month Extension (EXT) Phase.   "
248142|NCT01097629|"     This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to     placebo in improving insomnia as measured by change from baseline in: subjective total sleep     time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of     persistent sleep.   "
248143|NCT01097642|"     Ixabepilone and capecitabine combination has demonstrated to be an active regimen in patients     with metastatic breast cancer after failing other treatments. Cetuximab is active against     tumors expressing epidermal growth factor receptor w/demonstrated activity in head & neck and     colorectal tumors and may be effective in some breast cancers known to express EGFR. Study     seeks to evaluate Ixabepilone alone or in combination with cetuximab as a an antitumor     therapy w/randomization stratified by stage (T1N1-3M0 or T2-4 N0-3M0).   "
248144|NCT01097655|"     The objective of this study is to observe and collect data on the usage, dosing,     tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human     immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the     impact on tolerability of changing therapy to Kaletra tablets from other regimens.   "
248145|NCT01097668|"     Phase 1 study to assess the safety and biological activity of ATX-MS-1467 in patients with     relapsing forms of multiple sclerosis. This will be an open label upward dose titration     involving injections on 9 occasions, each two weeks apart. After dosing is complete there     will be a 22 week follow up period. Blood samples will be drawn throughout the study to     monitor safety and the body's response to the injections and MRI scans will be performed on     several occasions to follow the course of the multiple sclerosis during the trial.   "
248146|NCT01097681|"     The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2     diabetes mellitus patients with normal renal function and those with mild or moderate renal     impairment.   "
248147|NCT01097694|"     The purpose of this study is to see whether a new investigational drug (Imatinib) may help     improve asthma in people whose symptoms are not well controlled with high dose inhaled     corticosteroid treatment.   "
248148|NCT01097707|"     The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic     Hyperplasia (BPH)   "
248149|NCT01097720|"     This study is investigating the neurodevelopmental effects of prenatal exposure to     lamotrigine (LTG), sodium valproate (VPA), or carbamazepine (CBZ) monotherapies. The     hypotheses to be tested include:        1. Exposure during pregnancy to CBZ, LTG, and VPA, each as monotherapy, is associated with          developmental delay with or without signs of autism.        2. Exposure to each drug (CBZ, LTG, and VPA) as monotherapy is associated with an increased          rate of occurrence of major malformations.        3. The child with major malformations is more likely to have developmental delay with or          without signs of autism than the child who does not have major malformations.        4. The occurrence of adaptive behavior outcomes will show a dose-response relationship with          the dose of medication taken by the mother in the first trimester.      The study population includes children 36-83 months of age who were exposed throughout     gestation to one of the three drugs of interest, as treatment for maternal seizure disorder.   "
248150|NCT01097733|"     Cardiac Resynchronization Therapy (CRT) is a widely accepted treatment that has led to     improved clinical outcomes for patients with refractory congestive heart failure (CHF),     systolic dysfunction, and wide QRS duration. However, it requires implantation of an     expensive device ($30,000) and about 1/3 of patients do not have clinical improvement.     Inadequate amounts of LV dyssynchrony or suboptimal lead placement may limit clinical     response. Dual-Source computed tomography (DSCT) allows for subtle detection during     myocardial contraction for assessing LV dyssynchrony, and can also assess coronary venous     anatomy and scar burden. Thus DSCT may be the ideal noninvasive modality to predict response     to CRT.   "
248151|NCT01097746|"     The goal of this clinical research study is to learn if therapy with bevacizumab,     carboplatin, and weekly doses of paclitaxel is safe and can be tolerated in patients with     newly diagnosed epithelial ovarian, primary peritoneal, or fallopian tube cancer. Researchers     will also study if and how well this study therapy may help to control the disease.   "
248152|NCT01097759|"     This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled     hemorrhoidopexy for prolapsed hemorrhoids.   "
248153|NCT01097772|"     A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal     Stent Graft System   "
248154|NCT01097785|"     Heart failure (HF) is a leading cause of morbidity and mortality in the United States with     the incidence and prevalence of the disease on a continual rise. An overactive sympathetic     nervous system has become a hallmark characteristic of HF. Although sympathetic activation is     initially beneficial to maintain cardiac output, blood pressure and perfusion to vital     organs, over the long term it becomes deleterious contributing to the worsening of HF and     sudden cardiac death. Indeed, recent findings in HF patients suggest that the sympathetic     overactivity is not just a marker of poor prognosis but it plays a causative role in the     development of the disease. Thus, the sympathetic nervous system constitutes a putative drug     target in the treatment of HF. However, despite aggressive medical management, including     conventional anti-adrenergic strategies, sympathetic nerve activity (SNA) has been shown to     remain abnormally high in HF patients and improvements in survival have been limited. Thus,     other treatment strategies that include reducing SNA and its deleterious consequences are     warranted. Recent findings from clinical trials indicate that 3-hydroxy-3-methyl-glutaryl     coenzyme A reductase inhibitors (statins) improve survival irrespective of cholesterol     lowering bringing the pleiotropic (i.e., cholesterol independent) effects of statins to the     forefront. An important pleiotropic effect recently reported in experimental HF, that has yet     to be directly tested in human HF, is the ability of statins to reduce resting sympathetic     outflow. Several studies in pacing-induced HF rabbits have demonstrated that statins     normalize the excessive sympathetic activation in the HF state. Thus, the goal of this     project is to determine whether these findings in experimental HF can be translated to the     clinical setting of human HF. Our central hypothesis is that statins reduce sympathetic     overactivity in HF patients. To test this hypothesis we will directly measure muscle SNA and     perform a randomized crossover placebo control study. Subjects will come to the research     laboratory before and after the administration of Simvastatin at a standard therapeutic     dosage of 40 mg. per day or placebo for 1 month   "
248155|NCT01097798|"     Multicenter, randomized, double-blind trial, to evaluate the efficacy and safety Aliviador     compared to Gelol in the relief of signs and symptoms in patients with contusions, sprains,     trauma and muscle injury start with less than 24 hours or patients of myalgia, myofascial     pain and tendinitis.   "
248156|NCT01097811|"     Comparison between the efficacy of two different antibiotics in patients with overt hepatic     encephalopathy. The study is randomized, controlled and double-blinded.   "
248888|NCT01107431|"     This study was designed to examine changes in capillary blood glucose and venous insulin     levels after a 70 gram oral sucrose challenge with and without simultaneous consumption of a     dietary supplement containing L-Arabinose and a patented version of chromium (LA-Cr).   "
248157|NCT01097837|"     Despite the importance of birth control to women of reproductive age, there has been little     formal investigation of the safety and effectiveness of birth control methods in women with     epilepsy. To remedy this, doctors from Harvard and Columbia University Medical Schools have     developed a website that offers a survey to help us gain more knowledge and some educational     material that will be updated regularly to provide the latest information. The ultimate goal     is to develop guidelines for the selection of safe and effective birth control methods and to     make sure that the best forms of birth control become available to women with epilepsy in all     communities of our society.      Go to www.epilepsybirthcontrolregistry.com take our survey and then catch up on the latest     information about birth control for women with epilepsy.   "
248158|NCT01097850|"     The purpose of this study is to determine whether henna paste is effective in the treatment     of hand-foot skin syndrome, induced by the drugs Capecitabine and pegylated liposomal     doxorubicin.   "
248159|NCT01097863|"     The purpose of this study is to validate the improvements to the inversion indicator.   "
248160|NCT01097876|"     The purpose of this study is to evaluate the safety and tolerability of PF-04447943, before     and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels     of both PF-04447943 and donepezil.   "
248161|NCT01097889|"     Supplementary feeding programs for children with moderate acute malnutrition have been     implemented in developing countries using treatment foods with minimal or no evidence of     their effectiveness. Fortified peanut paste is a popular new treatment food for children with     severe and moderate malnutrition.      Objectives: To investigate the relative effectiveness of two non-identical therapeutic foods     in children with moderate malnutrition by comparing differences in performance indicators     (i.e. recovery rates), recovery times, and change in weight-for-height z-scores in each     group.      This proposed research project will evaluate the relative effectiveness of two non-identical     treatment foods for the treatment of moderate acute malnutrition in children   "
248162|NCT01097902|"     The experimental pain model studied in this proposal show characteristics of an inflamed     wound with a pro-inflammatory response. This study will help discover candidate genetic     and/or proteomic pain biomarkers that could provide objective and mechanism based tests to     diagnose, monitor or quantify pain. We also hope to determine the measurable effects of a     known non-steroidal anti-inflammatory drug (NSAID) on biomarkers of pain and inflammation.   "
248163|NCT01097915|"     The investigators evaluate the possible association of PROP taste with gustin gene     polymorphism rs2274333 (A/G), salivary zinc ion concentration and BMI. In addition, it has     also been evaluated PROP taste sensitivity by recording monophasic potentials from the     tongue.   "
248164|NCT01097928|"     A prospective observational study to evaluate the safety and effectiveness data of     catheter-directed therapy (CDT) including percutaneous mechanical thrombectomy (PMT) for     treatment of acute pulmonary embolism (PE)   "
248165|NCT01097941|"     A total of 51 children between the ages of 4 and 9 will be randomized to receive a two dose     schedule of either licensed live attenuated A/California/07/09 influenza vaccine (LAIV) or     licensed inactivated A/California/07/09 influenza vaccine (IIV) or IIV followed by LAIV     separated by 28 days. Children with prior vaccination or natural infection with novel H1N1     influenza will be excluded. Randomization will be stratified by pre-existing HAI titers to     the previous winter's seasonal H1N1 A/Brisbane/57/07 reference virus.   "
248166|NCT01097954|"     Exercise induced bronchospasm (EIB), also known as exercise induced asthma (EIA) is a     transient obstruction to airflow triggered by exertion.      It is now a well known identity, center of discussion in recent years, particularly in the     athletes' world. It is more common in asthmatic individuals (regardless of severity of     disease), but it is also seen in otherwise healthy subjects, leading to the general consensus     that the pathophysiology is different than asthma.      The concentration of exhaled nitric oxide (FeNO) in various airway & respiratory disorders,     particularly asthma, has been deeply studied. Its use for noninvasive monitoring of asthma     control (reflecting airway eosinophilic inflammation) is being closely examined and put into     clinical practice. FeNO is significantly elevated in asthma. Elevated FeNO levels have also     been noted in patients hospitalized with a COPD exacerbation, acidosis, rhinitis,     bronchiectasis, active pulmonary sarcoidosis, active fibrosing alveolitis, and acute lung     allograft rejection. Decreased FeNO levels have been seen in patients with primary ciliary     dyskinesia, cystic fibrosis, PiZZ phenotype-related alpha-1 antitrypsin deficiency, and     pulmonary hypertension      Two studies have addressed the variations on FeNO after EIB and they had contradictory     results. Scollo et al. found no change in FeNO in either healthy or asthmatic children after     a 6-min of vigorous exertion in an exercise laboratory when they studied 24 asthmatic and 18     control children. Terada et al. reported, for 39 subjects, a decrease in FeNO in subjects     with EIB and an increase in healthy controls.      It is well accepted that the pathophysiology of exercise induced bronchospasm it is not     similar to that of asthma. Certainly the inflammation in the airway does not appear to be     eosinophilic. Understanding the disease mechanism is a key factor to adequately manage it.      This will be a prospective study measuring online exhaled nitric oxide involving children 8     to 21 years old. The study group will include any children coming for a pulmonary exercise     test in the exercise laboratory located in the Pediatric Pulmonary Division office.      The study will be conducted from the fall of 2009 until the spring of 2011. The change in the     FeNO measurement will be correlated with the change in % predicted FEV1. We will consider     significant a decrease in FEV1 post exercise of 15% and/or decrease on FEF25-75 of 20% that     will persist until 15 minutes after completing exercise.      We will also record any symptoms reported by the subject during or after the test.      An exercise test is a standard of care when suspecting exercise-induced asthma. The subjects     and their parents coming for exercise test will be offered the opportunity to participate in     the study.      The subject will come for the exercise test and will perform spirometry and FeNO measurement     prior to start the test. According to our exercise laboratory protocol 1 minute of warm up at     a low speed, followed by 6 minutes of high speed (enough to increase heart rate to 90%     predicted or more) and 3 minutes of cool down at a low speed will be performed.      Then spirometry will be repeated at 3, 5, 10 and 15 minutes and FeNO measurement will be     taken at 5, 10 and 15 minutes.      We will analyze the data to find if there is any significant change in FeNO measurements     after exercise.   "
248167|NCT01097967|"     The study aims to observe the short term effect (3-month) of sleep disordered breathing (SDB)     on cardiovascular parameters, heart rate variability, endothelial function and surrogate     markers of atherosclerosis after acute cerebrovascular events (ACE). The long-term effect     (6-24-month) of Continuous Positive Airway Pressure (CPAP) on clinical vascular outcome,     cardiovascular parameters, evolution of surrogate of atherosclerosis heart rate variability     and endothelial function after ACE is observed over 24 months. A preventive effect of CPAP     therapy on cerebro-vascular events in patients with moderate-severe obstructive SDB without     sleepiness after ictus or transient ischaemic attack will be evaluated.   "
248168|NCT01097980|"     The aim of this study is to investigate the efficacy of trazodone in the treatment of     selective serotonin reuptake inhibitor(s) associated sexual dysfunction. The secondary     domains assessed were the relationship between 5-HT2A polymorphism and treatment efficacy.   "
248169|NCT01097993|"     The purpose of this study is to evaluate the effect of a commercially available fermented     dairy product containing probiotics (4 weeks, twice a day) on abdominal distension in IBS     patients with constipation (IBS-C).   "
248171|NCT01098019|"     Patients will be randomized (1:1) to receive either injections of Xeomin in 0.9% NaCl or NaCl     alone. Xeomin will be reconstituted with 2 mL of NaCl 0.9 which will give a final     concentration of 5 U of botulinum toxin A per 0.1 mL. The area affected will be injected with     0.1 mL at each 1-2 cm2 for a maximum total dose of 200 units. Patients will be evaluated at     Weeks 8, 12, 18 and 24. An unblinded pharmacist or designee will prepare placebo and Xeomin     injections. Patients will be unblinded at the end of the week 12 visit. After unblinding (at     week 12) patients who were randomized to placebo will receive Xeomin while patients initially     randomized to Xeomin will not be injected. All patients will be seen for follow-up visits at     Weeks 18 and 24. Efficacy in reducing pruritus will be measured with a 10 cm visual analogue     score. This will be performed at Day 0, Week 8, Week 12, Week 18 and Week 24. Efficacy will     also be measured by measuring the area of the hyperpigmented zone on the back. Safety will be     evaluated with adverse events.   "
248198|NCT01098383|"     We propose a study which will combine multiple modalities in evaluating the treatment     response of children with autism spectrum disorders (ASD) to acetyl-choline esterase (AChE)     inhibitors and choline supplements. The primary objective of the study is to examine the     efficacy of this treatment in improving core autistic symptoms. The Secondary objective of     the study is to evaluate the safety and tolerability of the treatment protocol in ASD     children. Exploratory objectives include evaluation of the influence of the treatment on     linguistic performance, comorbid behaviors, adaptive functioning and executive functions.   "
248258|NCT01105052|"     The purpose of this study is to investigate whether a self-help book for insomnia, with or     without therapist support, can improve sleep and alleviate insomnia symptoms in individuals     suffering from insomnia, also for persons presenting with different kinds of co-morbid     problems.   "
248172|NCT01098032|"     The purpose of the present study is to assess the role of the RenalGuard System as compared     to the optimal strategy (sodium bicarbonate infusion plus N-acetylcysteine (NAC)) in high and     very-high risk patients to prevent contrast-induced acute kidney injury contrast induced     acute kidney injury (CI-AKI).      Consecutive patients with chronic kidney disease, referred to our institutions for coronary     and/or peripheral procedures, will be randomly assigned to 1) prophylactic administration of     sodium bicarbonate plus NAC (Systemic alone therapy group; n > 133) and 2) RenalGuard System     treatment (RenalGuard group; n > 133). All enrolled patients must have an estimated     glomerular filtration rate <30 ml/min/1.73 m2 and/or a contrast nephropathy risk score ≥11).     In all cases iodixanol (an iso-osmolar, non ionic contrast agent) will be administered. The     primary end point is an increase of >=0.3 mg/dL in the creatinine concentration 48 hours     after the procedure.      This study will give important answers on how to prevent CI-AKI in high and very-high risk     patients undergoing contrast media exposure.   "
248173|NCT01098045|"     The specific aims of this study are to determine whether HIV-infected patients with     significant fat redistribution and ectopic fat accumulation have increased brown adipose     tissue using 18F-FDG Positron Emission Tomography techniques.      Recent studies suggest down regulation of Dicer, a major component of miRNA has an important     role in the differentiation and function of brown and white adipose tissue and may contribute     to lipodystrophy. Therefore we will expand on recent research in this area by recruiting     HIV-infected men with lipodystrophy. We will perform subcutaneous fat biopsies of the     dorsocervical and abdominal fat in a subset of HIV-infected and non-HIV-infected men in order     to explore further the question of down regulation of Dicer and its implication on metabolic     abnormalities in this population.   "
248174|NCT01098058|"     The purpose of the study is to compare the effectiveness of cognitive-behavioural therapy     (CBT) plus treatment as usual with treatment as usual only in treating adults with attention     deficit hyperactivity disorder (ADHD).   "
248175|NCT01098071|"     To document the short term & long term effect of treatment with Nasonex (mometasone furoate     nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of the     posterior choanae).   "
248176|NCT01098084|"     The aim of this study is to determine the therapeutic efficacy of Decitabine in patients with     chronic myelomonocytic leukemia (CMML) diagnosis according to WHO criteria either untreated     or previously treated with Hydrea or Etoposide (given orally), non intensive chemotherapy or     intensive chemotherapy given more than 3 months before inclusion.   "
248177|NCT01098097|"     To study retreatment in patients who failed prior treatment with interferon alpha (pegylated     or non-pegylated) with or without ribavirin in a real-life setting in an     observational/noninterventional study.   "
248178|NCT01098110|"     A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the     efficacy and safety of asenapine compared with placebo in participants with an acute     exacerbation of schizophrenia.   "
248179|NCT01098123|"     The aim of this study was to assess the relevance of NRI or athletes' NRI (ANRI) utilization     to detect nutrition-related risks of failure in competition in the particular population of     rowers.      In the morning, 60 to 90 minutes before the first race of a national level multi-races     competition (three races for each subjects), body weight were measured and blood samples were     collected with subjects at rest and in post-absorptive condition (last meal at least 2.5     hours before blood collection). Body weight was also recorded in the same conditions six     weeks before the competition to calculate weight state (actual weight /usual weight ´ 100)     and subjects were asked to identify the date of diet beginning. Body weight was measured     using a floor scale (Mettler-Toledo floor scale, France), body mass index (BMI) was     calculated from the ratio of weight (in kg) by height squared (in meters) and training volume     (total duration of training in a week) was determined after discussion with athletes and     coaches.   "
248180|NCT01098136|"     The objectives in this study are        1. to explore the incidence and cumulative prevalence of pelvic girdle pain (PGP) and its          subgroups in a prospective longitudinal study during pregnancy, from 18 weeks until 6          weeks after delivery.        2. to examine the outcome of chiropractic management for a dominating one-sided PGP          subgroup of pregnant women in a single-blinded controlled study, and to use efficacy          measures that include pain, functional impairment, and sick-leave frequency.        3. to investigate possible predictors for treatment outcome in one-sided PGP in pregnant          women.   "
248181|NCT01098149|"     Diabetic nephropathy is becoming the most common primary renal disease in end stage renal     disease patients. The prevalence of diabetic patients in dialysis reaches even the 30% of the     dialysis population (USRDS) with an incidence rate, in some countries, up to 40%. The 5 years     surviving time of diabetic patients in dialysis is about the 20% and, compared to the     hypertension and glomerulonephritis complications, still remains the worst. Diabetes is often     associated to several comorbid factors such as hypertension, autonomic neuropathy,     vasculopathy, metabolic disorders (ketoacidosis, poor glycaemic control), and electrolyte     disorders. So, the diabetic patient is fragile, with a rather poor tolerance to dialysis,     lack of achievement of dry body weight and inadequate dialysis. In order to gain a more     detailed insight into a possible better tolerance to dialysis, arising from the elimination     of acetate in dialysate bath (Acetate Free Biofiltration) and from the use of an automatic     system to control the blood volume (Blood Volume Control),the investigators would like to     investigate the cardiovascular stability and the frequency of intradialytic symptoms in a     prospective, randomized, cross-over study.   "
248199|NCT01104025|"     Despite good progress during the last decade, hemophagocytic lymphohistiocytosis (HLH)     remains difficult to treat. Two different treatment regimens have been used successfully. The     first one, a treatment regimen based on two drugs called etoposide and dexamethasone, has     been used worldwide. The second regimen, based on two drugs called Anti-thymocyte globulin     (ATG) and prednisone, has been used mostly at one hospital in Paris, for over 15 years. With     either regimen, about three quarters of treated children survive the most difficult time, the     first two months after diagnosis. These two different regimens appear to work somewhat     differently, and we suspect that combining them may give better results than either regimen     alone. We are conducting this clinical trial to test the combination of ATG, dexamethasone,     and etoposide for the treatment of HLH.      The purpose of this research study is to find out what effects (good and bad) this drug     combination has on you and your HLH.   "
248187|NCT01098227|"     The fraction of exhaled nitric oxide (FeNO) in expired air is a reliable measure of airway     inflammation and has been used as a marker in asthma and other respiratory illnesses such as     primary ciliary dyskinesia, bronchopulmonary dysplasia (BPD), liver cirrhosis, chronic     obstructive pulmonary disease (COPD), cystic fibrosis (CF). Although, some exquisite bench     research experiments have demonstrated stimulation of nitric oxide production in respiratory     epithelial cells infected with RSV, there is a paucity of clinical data regarding levels of     feNO in viral respiratory illness and specifically RSV.      The investigators conducted a pilot study from the fall of 2007 until October of 2009,     looking at FeNO levels in RSV infected patients and compared it to non-RSV viral infections.     The investigators recruited a total of 28 RSV positive and 1 RSV negative subjects, as well     as 4 control subjects. The investigators found FeNO values not statistically significant     between the study group (the two-tailed p=0.09, considered not quite significant), but there     was a trend of higher FeNO values in the non-RSV group when compared to the RSV group. A     larger sample may detect a statistically significance between these 2 groups.      Objectives:      i. To determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized     pediatric patients with viral lower respiratory illness when compared with normal subjects     without respiratory symptoms.      ii. To determine if there is a difference in feNO level between RSV and non-RSV infection in     hospitalized pediatric patients with viral lower respiratory illness.      Method of feNO measurement utilized the offline options for preschool children & infants     appropriate for age as described in the 2005 Joint Statement of the American Thoracic Society     & the European Respiratory Society when discussing tidal breathing techniques with     uncontrolled flow rate.      The investigators plan that our sample sizes for the RSV+ and control groups will be, by     design, three times as large as the RSV- group. In order to achieve 80% power, the     investigators will then require 45 control and 45 RSV+ patients, and 15 RSV- patients   "
248188|NCT01098240|"     The primary objectives of this study are to: 1) Evaluate the efficacy of CP 601,927 compared     to placebo in the augmentation of antidepressant therapy (ADT) in patients with Major     Depressive Disorder (MDD) using the Montgomery Asberg Depression Rating Scale (MADRS). 2)     Evaluate the safety and tolerability of CP 601,927 in patients with MDD on ADT.   "
248189|NCT01098253|"     The goal of this proposal is to integrate depression services into improving adherence for     oral hypoglycemic agents so that a single program can assist patients. The investigators     hypothesized that patients in the intervention would demonstrate improved adherence to     patients' oral hypoglycemic agents and antidepressants as well as improved clinical outcomes.   "
248190|NCT01098266|"     The main objective of the trial is to document the efficacy of NGR-hTNF administered at low     dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a     pemetrexed-based chemotherapy regimen.   "
248191|NCT01098279|"     The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network     has been established to focus on a broader approach to the study of Interstitial Cystitis     (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic     Pelvic Pain Syndrome (CPPS) in men, than previously undertaken. Participants with some form     or symptoms of IC or CP are being asked to join the Trans-MAPP Epidemiology and Phenotyping     (EP) Study.      As with many chronic pain disorders, IC and CP are poorly understood, and treatment is often     not helpful. The goal of this study is to better understand how pain is felt in people with     IC or CP. The MAPP EP Study is an observational study that will enroll approximately 360     participants from 6 Discovery Sites and 3 Satellite Sites across the U.S. We will ask     questions and gather information about the health and life of the participants for research     purposes. No study treatment or interventions will be given to participants in MAPP. We hope     that this study will lead to improvement in the treatment of IC and CP.   "
248192|NCT01098292|"     The Control Study for the Multidisciplinary Approach to the Study of Chronic Pelvic Pain     (MAPP) Research Network has been established to focus on a broader approach to the study of     Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic     Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken.      Participants with no Urologic Pelvic Pain Syndromes as well as participants with specific     conditions (Fibromyalgia (FM), Irritable Bowel Syndrome (IBS), Chronic Fatigue Syndrome     (CFS)) are being recruited for the Trans-MAPP Control Study. These participants will act as a     reference/control group for the Trans-MAPP Epidemiology & Phenotyping (EP) Study.      As with many chronic pain disorders, IC and CP are poorly understood, and treatment is often     not helpful. The goal of this study is to better understand how pain is felt in people with     IC or CP. The MAPP Control Study is an observational study that will enroll participants from     6 Discovery Sites and 3 Satellite Sites across the U.S. The investigators will ask questions     and gather information about the health and life of the participants for research purposes.     The investigators hope that this study will lead to improvement in the treatment of IC and     CP.   "
248193|NCT01098305|"     This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco     users with cessation efforts.   "
248194|NCT01098318|"     Prior research has shown that Rhodiola rosea may be an effective, short-term, anti-depressant     therapy. This study will examine the anti-depressant effect of Rhodiola rosea vs. a     conventional, anti-depressant drug in the treatment of major depression.   "
248195|NCT01098331|"     RATIONALE: Receiving standard information and watching a video or DVD at home that describes     treatment options and treatment outcomes may help patients decide to receive treatment in a     clinical trial.      PURPOSE: This randomized clinical trial is studying implant radiation therapy to see how well     it works compared with surgery in treating patients with prostate cancer.   "
248196|NCT01098344|"     RATIONALE: MK0752 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving MK0752 together with gemcitabine hydrochloride may kill more tumor     cells.      PURPOSE: This phase I trial is studying the side effects and best dose of giving MK0752     together with gemcitabine hydrochloride and to see how well it works in treating patients     with stage III or IV pancreatic cancer that cannot be removed by surgery.   "
248197|NCT01098357|"     This is an open-label, active-control, multicentre, parallel group, randomised and     dose-finding efficacy and safety study.      Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days     for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks     for the treatment of neuropathic diabetic foot ulcer.      Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days     for up to 20 weeks.   "
248250|NCT01104948|"     This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing,     dose-escalation study. The study is designed to describe the relationship between multiple     doses and pharmacokinetic parameters of DA-8031 as well as safety profile.   "
248200|NCT01104038|"     Childhood obesity has increased in prevalence over the past several decades and is predictive     of adult type 2 diabetes and cardiovascular disease (CVD). Recent studies of children and     youth suggest that exercise reduces cardiometabolic risk factors. Minimal data are available,     however, on the effects of exergaming , interactive technology- mediated approaches to     increasing physical activity in children and youth. This project involves a partnership     between UMass Boston/GoKids Boston and Children's Hospital Boston featuring an     interdisciplinary team of researchers and clinicians from pediatric cardiology, nursing,     prevention and behavioral sciences and exercise physiology and is designed to examine the     effects of exergaming on moderate or vigorous physical activity (MVPA) indices of adiposity,     risk factors for cardiometabolic disease and self-competence in Boston Public School     children. It is hypothesized that participation in the EXCEL/exergaming intervention for 60     minutes, three times per week for 12 weeks will significantly increase MVPA (as measured by     accelerometers), pre- to- post intervention and compared to an Advice only (Nutrition     Education) group.Results of this pilot study will guide and inform a larger study of     exergaming in children from the Boston Public Schools.   "
248201|NCT01104051|"     Trial will enroll qualified subjects at a 2:1 ration to receive radiofrequency ablation or     sham. At six weeks follow up they will be unblinded; sham subjects will then be given option     to receive treatment.      Subjects will be followed after procedure for data collection for economic outcomes and     efficacy of treatment.   "
248202|NCT01104064|"     The strategy in rehabilitating pediatric hemiplegia is to overcome developmental disuse.     Disruption of the excitability in the non-stroke hemisphere, with resultant increased     excitability (disinhibition) in the stroke hemisphere, can be achieved with low-frequency     repetitive transcranial magnetic stimulation (rTMS), a noninvasive method of stimulating     targeted areas of the brain. Furthermore, the disruptive effects of low-frequency rTMS can be     increased and prolonged by preceding it with 6-Hz priming stimulation. We have recently     demonstrated the safety of this priming/low-frequency rTMS in adults with stroke and we are     currently engaged in an NIH-funded study exploring the effectiveness, mechanism and safety of     serial treatments of rTMS combined with motor learning training. Very little research,     however, has been attempted on interventions to promote brain reorganization and recovery in     hemiplegia in children. Thus, this study will determine the effectiveness, mechanism, and     safety of 5 treatments of 6-Hz primed low-frequency rTMS applied to the non-stroke hemisphere     and combined with constraint induced therapy (CIT) to promote recovery of the paretic hand.     Fifteen children with pediatric hemiplegia, age 8 -16 years, at each of two pediatric medical     facilities (total N = 30), will be randomly assigned to one of two treatment groups that will     receive treatment for 2 weeks. The rTMSreal/CIT group will receive alternating days of the     real rTMS and CIT for 5 treatments of each. The rTMSsham/CIT group will receive alternating     days of sham rTMS with real CIT for 5 treatments of each. Subjects will be tested at pretest     and posttest. The hypotheses are: 1) the rTMS treatment will show no serious side effects, 2)     both groups will show improvement in hand function but the rTMSsham/CIT group will show     significantly greater improvement, 3) the rTMSreal/CIT group will also show significantly     greater improvements in brain reorganization measured by paired-pulse TMS testing, cortical     silent period testing, and fMRI. The proposed research is important because very little     research on rehabilitation-induced brain reorganization has been done in pediatric     hemiplegia. It is innovative because it applies a technique never used before, i.e. 6-Hz     primed low-frequency rTMS combined with CIT. The potential impact of this research is a     radical change to pediatric rehabilitation that accomplishes a higher functional recovery.   "
248203|NCT01104077|"     This is a retrospective observational study to determine the proportion of patients with a     family history of pancreatic cancer and other malignancies among patients who have     intraductal papillary mucinous neoplasm (IPMN).      The investigators will be reviewing the demographic, clinical, radiologic, pathologic, and     follow-up information from the Pancres Center database. The investigators will also conduct a     chart review to collect information recorded by clinicians on each subject's family history     of malignancy and personal history of malignancy. Results of this database and chart review     will be incorporated into a datasheet in which all patient identifiers have been removed.      The primary outcome will be the percentage of IPMN patients with at least one first-degree     relative with pancreatic cancer or IPMN, or at least two first or second degree relatives     with pancreatic cancer, IPMN, or malignancies related to pancreatic cancer syndromes,     including colorectal, gastric, breast, ovarian, and melanoma neoplasms. Secondary outcomes     will be the relative risk of IPMN subtypes of higher malignant potential (main duct or mixed     type location), more advanced histology (carcinoma in situ or invasive carcinoma), and     recurrence following surgical resection amongst subjects with a family history.   "
248204|NCT01104090|"     The purpose of this study is to determine the safety and efficacy of the C-MAC (Karl Storz     Endoscopy, Inc., Tuttlingen, Germany) video intubation system guided intubation techniques.      We hypothesize that the C-MAC video laryngoscope is safe and efficacious in terms of     successful endotracheal intubation. The C-MAC may be a safe and suitable alternative device     for routine and difficult laryngoscopy and tracheal intubation. This is the first study to     investigate the performance of C-MAC in clinical practice.   "
248205|NCT01104103|"     The purpose of this study is to determine whether the BOA(R)-Constricting IV Band is superior     to standard methods for starting an IV.   "
248221|NCT01104311|"     To develop adequate blood pressure (BP) lowering strategy after subacute ischemic stroke     patients with symptomatic severe intracranial atherosclerosis.      Primary hypothesis of this study is that aggressive BP control (lowering systolic BP between     110mmHg and 120mmHg) will not increase the ischemic lesion volumes in hemisphere compared to     modest BP lowering (lowering systolic BP between 130mmHg and 140mmHg) in the patients with     symptomatic severe intracranial atherosclerosis.   "
248206|NCT01104116|"     Intraductal papillary mucinous neoplasm (IPMN) is a cystic pancreatic lesion that is a     precursor to invasive pancreatic cancer. Differentiating whether an IPMN lesion is benign or     malignant is critical, as the prognosis and management differs drastically, varying from     surgery to clinical observation. However, despite physicians' attempts to characterize     features concerning for malignancy, it is difficult to determine the likelihood of malignancy     with conventional imaging techniques, and an accurate and non-invasive test to identify     malignant IPMN is needed. Our hypothesis is that positron emission tomography (PET), a     three-dimensional imaging that can identify cancer cells through their increased use of     sugars, may be a superior test for differentiating between benign and malignant IPMN lesions.     The investigators are planning a prospective pilot study of patients with IPMN who are     undergoing surgery for their disease. These patients will undergo PET imaging, as well as     computed tomography (CT), magnetic resonance imaging (MRI), and endoscopic ultrasound (EUS)     as clinically indicated. Samples of tissue removed during surgery will be assessed and will     serve as the gold standard for determining whether the lesion is benign or malignant. The     investigators will evaluate the positive and negative predictive values of PET imaging for     malignancy within IPMN lesions.   "
248239|NCT01104805|"     The main objective of this study is to evaluate the effectiveness of including an     interactive, web-based version of the Community Reinforcement Approach (CRA), called the     Therapeutic Education System (TES), as part of community-based, outpatient substance abuse     treatment.   "
248207|NCT01104129|"     The purpose of this study is to determine if pancreatic cancer/pre-cancer can be detected in     early stages through the molecular analysis of stool samples. Investigators hypothesize that     analysis of stool samples using digital melt curve (DMC) analysis, can be used as a sensitive     and specific method to detect the common genetic abnormalities present in pancreatic cancers     and pre-cancerous lesions of the pancreas.   "
248208|NCT01104142|"     The purpose of this study is to evaluate the effectiveness of the Continuous Glucose     Monitoring System (DexCom™ SEVEN PLUS®) and to evaluate the impact of CGM on glycemic control     when worn for up to 6-months by subjects 18 to 70 years-old with Type 1 diabetes mellitus on     MDI or CSII therapy.      The primary objective of this study is to demonstrate no statistically significant     differences between MDI and CSII subjects in terms of A1C change at 6 months as compared to     baseline. A secondary objective is to evaluate time spent outside of the euglycemic region     (70 to 180 mg/dL) from the baseline (blinded month) to the conclusion of 6 month follow-up.      Safety data of the SEVEN PLUS System will also be collected and safety will be characterized     by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated     Adverse Device Effects experienced by study participants.   "
248209|NCT01104155|"     This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin     mesylate in combination with intermittent erlotinib in patients with previously treated,     advanced non-small cell lung cancer.   "
248210|NCT01104168|"     Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75     years and 40% of adults >80years of age. Management of hyperglycemia is challenging in the     geriatric population in long-term facilities. Numerous factors place hospitalized patients at     increased risk for hyperglycemia including aging, sedentary life, stress of medical and     surgical comorbidities, and changes in antidiabetic regimen. In addition, elderly patients     often experience changes in their nutritional intake and organ dysfunction which increase the     risk of hypoglycemic events.      There are only a few retrospective studies in elderly patients analyzing quality of diabetes     care and glycemic control adjusted for medications and presence of co-morbidities in     long-term care facilities. In addition, no randomized controlled trials have demonstrated     benefits of glycemic control on clinical outcome, quality of life, and rate of acute     metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities.   "
248211|NCT01104181|"     This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV     and whether this aids in identifying individuals are risk for anal cancer or precancerous     lesions.   "
248212|NCT01104194|"     The investigators recently found a positive effect of omega-3 supplements on cognitive     function in healthy individuals after 4 weeks (J of Psychopharmacology 2009, 23: 831-840).     The investigators hypothesize that 4 weeks consumption of omega-3 supplements in previously     depressed individuals will positively affect their cognitive functions.      Secondly, low Heart Rate Variability (HRV) is a risk factor for cardiovascular disease. Some     studies have found low HRV in patients with depression. No studies have investigated the     effects of omega-3 fatty acid supplements on Heart Rate Variability in individuals with a     history of depression. The investigators will test the hypotheses that omega-3 supplements     lead to an improvement of heart rate variability indices in healthy volunteers with a history     of depression.   "
248213|NCT01104207|"     The purpose of this study is to assess the effectiveness of repetitive transcranial magnetic     stimulation (rTMS) for reducing the loudness or severity of chronic tinnitus.   "
248215|NCT01104233|"     The purpose of this study is to see if different types of spreading (rigid or soft) of     Video-assisted Thoracoscopic Surgery (VATS) for lung cancer have different effects on pain.   "
248216|NCT01104246|"     The study will evaluate the pharmacokinetics of testosterone transdermal systems at     steady-state in hypogonadal men.   "
248217|NCT01104259|"     This phase I trial studies the side effects and best dose of veliparib when given together     with cisplatin and vinorelbine ditartrate in treating patients with breast cancer that has     returned or spread to other parts of the body. Veliparib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     cisplatin and vinorelbine ditartrate, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving veliparib together with combination chemotherapy may be a better treatment     for breast cancer.   "
248218|NCT01104272|"     The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt     subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such     as a reduction in waist circumference.   "
248219|NCT01104285|"     The purpose of this study is to determine whether chest tubes to drain transudative pleural     effusions helps patients come off mechanical ventilation earlier.   "
248222|NCT01104324|"     Acute lymphoblastic leukemia is the most common form of childhood cancer with current     treatment survival rates approaching 80%. Improved outcomes show an increased number of     survivors at risk for long-term treatment related side effects including osteonecrosis.     Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and     poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the     usual presenting symptom and may become severe requiring surgical decompression or     replacement of the affected joint. Long-term effects including arthritis and progressive     joint difficulties will not be known for decades. This study aims to determine the risk     factors for developing osteonecrosis that will lead to information for earlier detection and     prevention. The study will be the basis for future intervention and prevention trials.   "
248223|NCT01104337|"     The objective of this study is to investigate whether paracetamol, given at therapeutic doses     (2g/day and 3 g/day), may potentiate the anticoagulant effect of warfarin.   "
248224|NCT01104350|"     The purpose of this study is to test the safety of different amounts (doses) of external     radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with     chemotherapy.   "
248225|NCT01104623|"     The purpose of this study is to detect specific vocal acoustic patterns in the voice of     attention deficit hyperactivity disorder (ADHD) patients.   "
248889|NCT01107444|"     The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination     with docetaxel compared to docetaxel alone in patients with non-small cell lung cancer who     were previously treated with first line chemotherapy.   "
248226|NCT01104636|"     The aim of this study is to determine the success rates for stopping smoking with varenicline     in Germany. The main measure of success will be continuous abstinence from smoking (not a     single puff) in the last week of the standard 12 week treatment period. Additional     information will be gathered regarding prescribing practices in Germany, smoking history,     reasons why smokers quit smoking and re-start smoking, smoking related illnesses and the     tolerability of varenicline.   "
248227|NCT01104649|"     The hereditary cerebellar ataxias include diverse neurodegenerative disorders. Hereditary     ataxias can be divided into autosomal dominant ataxias (ADCAs), autosomal recessive ataxias     (ARCAs), X-linked, and mitochondrial ataxias on the basis of mode of inheritance. The key     feature in all these disorders is ataxia typically characterised by poor balance, hand     incoordination, postural or kinetic tremor, dysarthria and dysphagia.      To date no treatment has been shown to slow progression of the disease and symptomatic     therapies are limited to few options that are partially effective.      Purkinje cells project inhibitory signals to the deep cerebellar nuclei(DCN) which have a     critical role in cerebellar function and motor performance. DCN neurons fire spontaneously in     the absence of synaptic input from Purkinje neurons and modulation of the DCN response by     Purkinje input is believed to be responsible for coordination of movement, while uncontrolled     spontaneous firing of DCN neurons may underlay cerebellar ataxia. Recent studies have     demonstrated that small-conductance calcium-activated potassium (SK) channels inhibitor are     able to increase DCN firing rate. Since SK channels are critical regulators of DCN firing     rate, SK openers such as the drug riluzole may reduce neuronal hyperexcitability and thereby     be useful in the therapy of cerebellar ataxia.      On this base the investigators published a pilot study in patients with chronic cerebellar     ataxia (Ristori et al., Neurology 2010) investigating safety and efficacy of riluzole or     placebo administration for 8 weeks. The results demonstrated a significative improvement in     International Cooperative Ataxia Rating Scale (ICARS) global score after four weeks and after     8 weeks in the riluzole arm.      The present protocol is aimed at verifying the safety and efficacy of riluzole administration     for a longer period, in a larger sample size of patients, with more stringent diagnostic     criteria (hereditary cerebellar ataxia), respect to the above pilot study. Sixty patients     will be enrolled in a double-blind, placebo-controlled trial. By central randomisation,     patients will take 50 mg of riluzole or placebo twice daily for 12 months. Treatment effects     will be assessed by comparing the Scale for the Assessment and Rating of Ataxia (SARA) before     treatment and during therapy at months 3 and 12.   "
248228|NCT01104662|"     This is a multicenter, randomized, evaluator-blinded, comparator-controlled study.     Participants were to be randomized (1:1) to daptomycin or comparator, stratified by degree of     renal impairment (creatinine clearance [CLcr] 30 - 50 milliliters per minute [mL/min]     [moderate impairment] and <30 mL/min [severe impairment]) and by type of infection     (bacteremia and complicated skin and skin structure infections [cSSSI]) to create 4 cohorts     defined as follows:        -  Cohort 1: Bacteremia and CLcr <30 mL/min        -  Cohort 2: Bacteremia and CLcr 30 - 50 mL/min        -  Cohort 3: cSSSI and CLcr <30 mL/min        -  Cohort 4: cSSSI and CLcr 30 - 50 mL/min      Participants will be treated and evaluated for safety and microbiological and clinical     efficacy in accordance with their type of infection and degree of renal impairment. Peak and     trough samples will be collected to assess exposure to daptomycin for participants on Day 1     and following the 5th dose.   "
248229|NCT01104675|"     The purpose of this study is to determine whether oral ENMD-2076 is effective in treatment of     patients with platinum resistant ovarian, fallopian, or peritoneal cancer. Additional sites     to be added.   "
248230|NCT01104688|"     The development of the abdominal aorta aneurysm is multifactorial. Through use of magnetic     resonance imaging without contrast, this study will look closely at flow, the stresses hereby     induced, as well as signs of inflammation in the vessel wall.   "
248231|NCT01104701|"     The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety,     and tolerability data in patients with type 2 diabetes to assess the feasibility of once     monthly dosing of the exenatide suspension formulation.   "
248232|NCT01104714|"     The purpose of this study is to determine if there is a correlation between tumor response     after 3 doses of chemotherapy by induction using Docetaxel, Cisplatine and 5-Fluorouracile     for advanced stage epidermoid carcinomas of the upper aero digestive tract and the presence     of one or a combination of 3 genetic polymorphisms and/or 5 intra-tumoral transcriptional     modifications.   "
248233|NCT01104727|"     The aim of this study is to compare results of the new surgical strategy to the traditional     4-ports technique for cholecystectomy in a randomized controlled trial (RCT). In particular     we are going to investigate the procedures in terms of overall morbidity, while taking into     considerations skin-incision's related morbidity, postoperative pain and cosmetic results     which are the hypothetical benefits of the new approach. Other parameters are supposed to be     unchanged, considering evidences from recent literature.      Surgical procedures:      4 ports cholecystectomy (4PC): a 12mmHg pneumoperitoeum is created either by a 10mm umbilical     Hasson's port or by a Verress needle followed by a 10mm umbilical port insertion; further one     10mm and two 5mm ports are placed according to the preferred technique.      Single Port Access cholecystectomy (SPC): the single-port device is inserted through the     umbilicus, by means of an adeguate incision, as the only access to the abdominal cavity. A     trans-abdominal suture in right hypochondrium is placed through the gallbladder wall of the     fundus to retract it.      Primary endpoint: overall morbidity rate (at 60 days from surgery)      Secondary endpoints:        1. skin-incision's related morbidity rate (at 60 days from surgery)        2. perioperative pain        3. cosmetic results        4. long-term morbidity (12 months)        5. intraoperative time        6. conversion SPC to 4PC rate        7. conversion to laparotomy rate        8. hospital stay   "
248234|NCT01104740|"     Dengue is an infectious disease most prevalent in the world. This disease is endemic in the     Caribbean, with an increase in seasonal rains. Several outbreaks have been observed in recent     years, in 2001, 2005 and 2007, during which further particularly virulent serotypes have     emerged. The clinical expression of dengue fever is variable, ranging from no symptoms to a     classical form with fever, and even of severe or lethal bleeding. With the possible existence     of silent forms of the disease, there are no data identifying the current level of protection     of the population in Martinique / Guadeloupe.   "
248235|NCT01104753|"     Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with     ulcerative colitis (UC).   "
248236|NCT01104766|"     The objective of this study is to evaluate the efficacy, safety, and tolerability of     cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.   "
248237|NCT01104779|"     The objective of this study is to evaluate the efficacy, safety, and tolerability of     cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.   "
248238|NCT01104792|"     The objective of this study is to evaluate the long-term safety, tolerability and     pharmacokinetics of cariprazine in patients with schizophrenia.   "
248240|NCT01104818|"     National estimates indicate that roughly 70% of children in foster care have one or more     siblings also in care. Exact percentages vary by state, but several data sources suggest that     about 50% of early adolescent foster youth are placed apart from one or more of their     siblings. Relationships between these siblings may be critical in providing them a sense of     connection and emotional continuity as they are removed from much that is familiar (e.g.     their home, parents, and friends). Historically, efforts to strengthen ties of foster     children with their families have focused on adults (e.g., biological parents, grandparents).     Limited research exists on the relationships of siblings in foster care. The central aim of     the proposed study is to evaluate the impact of the Sibling plus Parent Management Training     (SPMT) intervention as compared to Parent Management Training-only (PMT) on key constructs of     sibling relationship quality, mental health, academic success, and quality of life for youth     in foster care. Conducted in partnership with the Oregon DHS Foster Care program, 240 sibling     dyads and their foster parents will be enrolled in six cohorts. Siblings may live together or     in separate placements. Dyads will consist of (1) a target youth in care that is 11-15 years     of age, and (2) a younger sibling in care who is 7-15 years of age and within 4 years of age     of the target youth. Sibling dyads will be matched as living together or living apart; the     matched dyads will be randomly assigned to either the SPMT or PMT-only group, with all     study-enrolled foster parents receiving PMT intervention components. The SPMT intervention     includes a sibling component as well as foster parent PMT. The sibling intervention component     includes eight cognitive behavioral sessions of skills learning/practice, and four community     activities planned by siblings with their interventionist coaches. For foster parents, there     is a 4-session PMT curriculum emphasizing skills learning and practice with their     study-enrolled foster child. Additional sessions are available to foster parents on request.     Foster parents will also be able to access and troubleshoot PMT materials and strategies via     weekly staff check-in calls, and the project website. Major wave assessments will be     conducted at baseline, intervention termination (6 months), follow-along1 (6-month     post-intervention) and follow-along2 (12-month post-intervention). Brief, bi-monthly phone     interviews for youth and foster parents will collect service utilization data and global     ratings of outcome constructs for use in growth-modeling analyses. Hierarchical Linear Models     (HLM) and multiple regression analyses will be used to test (1) the prediction that SPMT     siblings will improve more than PMT siblings on key outcomes, and (2) whether intervention     efficacy varies by sibling placement (together vs. apart) and participant characteristics     such as race, gender, and disability   "
248241|NCT01104831|"     Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21     degree cryotherapy sleeves. Time to discharge and complications will be monitored.      Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome     measures: Satisfaction/pain relief and narcotic requirement   "
248242|NCT01104844|"     The aim of the study is to examine the dose response relationship in the treatment of dental     pain (teeth extraction) for the different potential doses of the investigational drug, i.e. 2     tablets, 1 tablet or ½ a tablet given 4 times a day.   "
248243|NCT01104857|"     Respiratory muscle dysfunction in critically ill patients is associated with elevated     morbidity, including prolonged weaning from mechanical ventilation. The causes for     respiratory muscle dysfunction in these patients is poorly understood and no effective     treatment is available.      The general hypothesis of the present study is that in critically ill mechanically ventilated     subjects respiratory muscle dysfunctions results from loss of myosin induced by activation of     proteolytic cascades.   "
248244|NCT01104870|"     This is a prospective, randomized, parallel group study to assess the hemodynamic effect of     three different dose regimens of a sustained release (SR) tablet of UT-15C in patients with     exercise-induced pulmonary hypertension (PH), as measured by the change in peak total     pulmonary resistance index (TPRI) during exercise from Baseline to Week 12.   "
248245|NCT01104883|"     The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at     reducing morphine consumption and pain, and at the same time improving mobilisation after     total knee arthroplasty.   "
248246|NCT01104896|"     Nicotine patches are frequently used in smoking patients during their stay in the ICU in     order to avoid tobacco's weaning symptoms which are likely to interfere with mechanical     ventilation weaning.      Until now the effectiveness of this treatment has not been proven. The aim of this study     (NICOREA study) is to determine if a difference exists on the duration of mechanical     ventilation once patients receive or not a nicotine substitute.   "
248247|NCT01104909|"     End-stage renal disease (ESRD) is a common clinical condition. In this population, the     prevalence of systemic hypertension is high and its adequate control can determinate the     outcome.      The first step for a good control of blood pressure in renal patients is adjusting his/her     dry weight. Actually, dry weight is assessed based on clinical examination and blood     pressure.      The electrical bioimpedance is a simple and portable device. The investigators design a     randomized clinical trial for evaluating two ways of getting the best dry weight for     hemodialysis patients.      A basal 24h ABPM will be taken before the randomization. Then, 2 weeks later the dry weight     be revised, the investigators will get a second 24h ABPM.   "
248248|NCT01104922|"     The primary objectives of this study are to determine the 1-year progression-free survival     (PFS) of previously irradiated patients with squamous cell carcinoma of the head and neck     (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities     associated with the above therapy.   "
248249|NCT01104935|"     To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and     combination therapy of trastuzumab and chemotherapy (H+CT group) based on a randomized     controlled trial in women over 70 years with human epidermal growth factor receptor type-2     (HER2) positive primary breast cancer.   "
248253|NCT01104987|"     This prospective study will assess the effects of treatment with alendronate in osteoporotic     patients with ankylosing spondylitis.      Primary objectives:        -  To investigate if alendronate effect bone mineral density (BMD) assessed by dual energy          x-ray absorptiometry (DXA) in lumbar spine, hip and distal forearm and assessed by          quantitative computed tomography (QCT) in lumbar spine and by Xtreme CT in radius and          tibia.      Secondary objectives:        -  To investigate if alendronate effects markers of bone remodeling        -  To investigate if alendronate influences disease activity (BASDAI), spinal function          (BASFI), spinal movement (BASMI) and health related quality of life (SF-36).   "
248254|NCT01105000|"     This is a survey study to assess the vaccination knowledge and attitudes of women in an inner     city Gynecology clinic. Results of this study will help determine which factors influence     vaccination knowledge and attitudes. This may help improve future vaccination tools.   "
248255|NCT01105013|"     This is a study clinical, multicenter, Phase III trial, to evaluate the efficacy and safety     of tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot,     Tinea and Tinea crural body.   "
248256|NCT01105026|"     The aim of this study was to evaluate by histology and MSCT scans during a 7-month period,     the efficacy of a bioactive glass (Inion BioRestore™) placed in human extraction sockets in     the maintenance of alveolar ridge.   "
248909|NCT01114178|"     Purpose is to test and validate a new questionnaire (the WELCH questionnaire) to estimate     walking capacity in patients with claudication   "
248259|NCT01105065|"     The investigators have completed a study in which the investigators examined the response of     the retinal circulation to changes in posture from sitting to lying down in patients with     Normal Tension Glaucoma (NTG). This alteration in position produces changes in the local     blood pressure at the entrance to the retinal vasculature. In a healthy retina, the     vasculature adapts by dilating and constricting in order to maintain a steady blood flow     rate. In an eye with NTG, this often does not occur. Upon analysis at the completion of the     study , the investigators found that the patients who had been taking Alphagan (brimonidine)     during the study did not exhibit the blood flow increases typical of NTG while lying down;     instead, they maintained a steady blood flow rate as did the group of healthy control     subjects. The investigators primary objective is to now demonstrate in a prospective study     that Alphagan can restore retinal vascular autoregulatory function in patients with NTG who     do not autoregulate. The investigators will also determine the effect of Alphagan treatment     on the patients' ability to detect motion.   "
248260|NCT01105078|"     Regardless of the development of cardiac surgery techniques and technologies, the question of     an optimal extracorporeal circulation is still unanswered. There are globally accepted     standards of perfusion, however, keep many of these procedures was not evidence-based review.      Generally accepted are flow rates during cardiopulmonary bypasses of 2.5 L/min/m2. This     target was derived from the physiological conditions, but they are not the result of an     adapted adjustment to the fundamentally non-physiological processes during extracorporeal     circulation. Among other things, an increased metabolic demand during re-perfusion is not     taken into account.      An increasing and optimizing of the standard flow rate of 0.5 L/min/m2 should be the aim of     this investigation. Under optimal perfusion, the investigators are maintaining the     microcirculation and organ protection in receipt of endothelial function and oxygen     transport.   "
248261|NCT01105091|"     This is a prospective, multi-center, open-label, randomized, Phase IV exploratory study     comparing safety, tolerability, pharmacokinetics, and effectiveness of ACT-385781A and Flolan     (epoprostenol sodium) in patients with pulmonary arterial hypertension who are naïve to     injectable prostanoid treatment and in need of such treatment. Approximately 30 patients from     8 U.S. clinical sites will be randomized to receive either ACT-385781A or Flolan (2:1     respectively) for 28 days of treatment.   "
248262|NCT01105104|"     The goal of the Enhanced Medication Management Program (eMMp) being developed by MedMinder     Systems, Inc. is to increase the ability of frail elders to adhere to complex medication     regimens for chronic conditions. Adherence will facilitate effective self-care and decrease     personal and societal costs associated with disease progression and loss of independence.     Multiple studies have shown that more frequent personal follow-up is the most effective way     to maximize medication adherence, but such personal care is too costly to translate well to     real life in a world of limited healthcare resources.      Currently available smart pillboxes are too expensive, too limited in the number and types     of medications delivered, and too technically complex for the large majority of senior     citizens. The eMMp is designed to deliver prompts and reminders to the user, to be remotely     programmable by caregivers, to allow the option of using pre-filled medication trays, to     provide electronic adherence reports to family/caregivers and to provide personalized     reinforcing phone calls from professional caregivers, all at a modest cost. The in-home     ReMinder will use a familiar pillbox layout (4 doses/day for 7 days) and allow easy removal     of medication cups by elderly, rheumatic fingers. Installation will require only an     electrical outlet (no modems or dedicated phone lines). Once plugged in, the built-in pager     will continuously download remotely programmed visual and/or aural prompts and reminders from     a central server (RemoteMind). It will continuously upload the date and time when each     medi-cation cup is removed and when weekly refill is carried out, enabling remote adherence     monitoring, alerts to caregivers, and follow-up intervention(s) from personal and/or     professional caregivers as needed.      The hypothesis to be tested in this 2 year SBIR Phase I work plan is that the eMMp will     significantly im-prove adherence and clinical outcome (blood pressure control) in a     population of frail elderly who are hyper-tensive. SBIR Phase II will determine the minimum     level of intervention needed to achieve sustained medication adherence and control of blood     pressure in a larger group of hypertensive elders.   "
248263|NCT01105117|"     This is an open-label, non-randomized extension to study AC-066A401. The study will assess     safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a     means for continuing treatment after ending participation in study AC-0066A401.   "
248264|NCT01105130|"     RATIONALE: L-arginine supplements may improve the quality of life and erectile function in     men who are prostate cancer survivors.      PURPOSE: This randomized phase II trial is studying how well L-arginine supplementation works     with or without enzyme inhibitors in treating erectile function and quality of life of     prostate cancer survivors previously treated with radiation therapy.   "
248265|NCT01105143|"     The investigators here propose to perform a prospective randomized intervention trial in     post-menopausal women to investigate the endocrine network, which contributes to the changes     in skeletal muscle mass during weight loss.   "
248266|NCT01105156|"     1. Background / Scientific Rationale      The VEW (Vomiting, Eating, and Weight Loss) Questionnaire has been developed as a method for     the assessment of post bariatric surgery patients, as well as a research tool into the eating     behaviour of these patients.      Objective VEW Questionnaire Premise If used optimally the VEW score is a valuable tool for     patients who have had Laparoscopic Gastric Band Surgery (LAGB). The VEW score will be able to     assist clinicians treating patients with a LAGB, specifically the Swedish Adjustable Gastric     Band (SAGB), by providing them a tool to enhance patient outcomes. By using the information     gained from the VEW questionnaire we can assess many areas of the eating behavior, and     adjustment outcomes in patients with Gastric Bands.      Hypotheses:        -  The VEW questionnaire aids in the assessment of the need for gastric band adjustment (up          or down in volume)             -  Comparison of patient factors in those who have had a                  1. good outcome (increased weight loss)                  2. bad outcomes (vomiting, low weight loss, maladaption), from a gastric band                    fluid addition             -  In patients who have had a bad outcome, which factors are more predictive?        -  Fewer Complications associated with Gastric Band Adjustments             -  Obstruction             -  Need for urgent deflation             -  Pain on eating             -  Lowering incidence of inappropriate fills             -  Lower incidence of maladaption        -  Eating behavior can predict long term outcomes           o By comparison of factors in the different quartiles of weight loss (particularly top          25% cf. bottom 25%)        -  Maintenance of weight loss after 12 months is best achieved by use of behavior          modification via improved food tolerances and better eating behavior than by increasing          restriction of the band by further adjustments. 12 months is chosen as an arbitrary time          where the majority of expected weight loss (45% of expected 50-55% 0f EWL) has been          achieved. It is also a time frame by which patients have learnt to use the band          appropriately, and the gastric band has had time to be adjusted into its optimal range.        -  The VEW questionnaire can help predict poor outcomes from a SAGB adjustment.             -  By analyzing the factors in patients who have returned both acutely (days) or at               subsequent visits (weeks) and had fluid removed from their bands. These factors               would include pain, vomiting, length of meals, maladaption score, fluid added, etc.   "
248280|NCT01105338|"     RATIONALE: Lycopene and green tea may stop or delay the development of recurrent prostate     cancer in patients has been treated for prostate cancer. It is not yet known whether lycopene     or green tea may be more effective in preventing prostate cancer.      PURPOSE: This randomized phase II trial is studying lycopene to see how well it works     compared with green tea in preventing prostate cancer in patients previously enrolled in the     ProtecT trial   "
248281|NCT01105351|"     The common polymorphism in MTHFR gene (C677T) has a significant effect on (6S)-5-CH3-H4folate     after folic acid supplementation. For example, post supplementation differences in     (6S)-5-CH3-H4folate between CC and TT are above 30%.   "
248267|NCT01105169|"     Colorectal cancer is the fourth most common incident cancer and the second most common cause     of cancer death in the United States, with approximately 150,000 new cases and 57,000 deaths     per year. High calcium intake and magnesium may protect against colorectal cancer and     adenoma, however, results have been inconsistent. We found that genetic makeup, associated     with magnesium absorption and re-absorption, significantly interacted with the calcium and     magnesium ratio in relation to the both adenomatous and hyperplastic polyps. Participants who     carried at least one 1482Ile allele (G->A)of TRPM7 and who consumed diets with a high     calcium/magnesium ratio were at a higher risk of adenoma and hyperplastic polyps than were     participants who did not carry the polymorphism. We hypothesize that the reduction in the     dietary Ca/Mg ratio may change the markers directly related to tumorigenesis. The primary     aims of this study are to conduct a randomized placebo-controlled intervention trial to test     whether reducing the Ca/mg intake ratio through magnesium supplementation has effects on the     related biomarkers. We will also examine whether the effect of modulating Ca/Mg intake ratio     may be more pronounced among those who carry the 1482Ile allele compared those who don't     carry the 1482Ile allele. Results from our study will help to identify people at a high risk     of colorectal adenoma and to develop personalized strategies to prevent occurrence of     colorectal adenoma, and thus, colorectal cancer through dietary change or nutritional     fortification.   "
248268|NCT01105182|"     The purpose of this study is to assess short and long term outcomes after radiofrequency     ablation (RFA) combined with chemotherapy for pulmonary malignancies in patients who are not     candidates for surgical resection. This study will evaluate the efficacy of RFA combined with     chemotherapy for the treatment of lung tumors by assessing its impact on local tumor control,     progression free survival, overall survival, dyspnea score and quality of life (QOL).   "
248269|NCT01105195|"     The purpose of this study is to 1) identify the common bacterial flora found on the skin     overlying the lumbar spine, and 2) evaluate the efficacy of readily available     skin-preparation solutions in the elimination of bacterial pathogens from the surgical site     following skin preparation (DuraPrep versus ChloraPrep).   "
248270|NCT01105208|"     A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over     design was used with a washout of 7 days between the two study periods. Treatment groups     balanced with the same number of healthy volunteers who were randomly (in two strata: male     and female) assigned to the study drug administration sequences   "
248271|NCT01105221|"     The purpose of this study is to assess whether acupuncture is more effective than artificial     tear drop in the treatment of dry eye.   "
248272|NCT01105234|"     The purpose of this trial is to compare the skin irritation potential of eight different     formulations of vitamin D analogues after repeated applications on intact skin of healthy     subjects.   "
248273|NCT01105247|"     The purpose of this study is to establish the safety and efficacy of orally administered     PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.   "
248274|NCT01105260|"     Reconditioning program during the chronic phase of the spinal cord-injury is well known for     its beneficial effects, but there is no investigation in early rehabilitation consequences.     Nevertheless, it may be justified : to increase oxygen uptake; to decrease the risks of     medical complications; or to improve the mobility. The restrictive autonomy is due to     different factors: firstly wheelchair users reduce their movement because they need technical     or human help to achieve transfers; and secondly, locomotion is performed by the upper limbs.     Without specific practice, the upper limbs mechanical and physiological properties do not     permit exercises that are long and intense. Then, the purpose of this research is to evaluate     the effects of an 8 weeks interval training program on wheelchair independance during     inpatient early rehabilitation for spinal cord injury (3 to 6 months post injury) compared to     a control group (classical rehabilitation program in a physical medicine and rehabilitation     department).   "
248275|NCT01105273|"     Rationale: Chemotherapy with fludarabine, cyclophosphamide and anti-thymocyte globulin may     induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical     allogeneic hematopoietic cell transplantation. In addition, depletion CD3±CD19 cells may     contribute to prevent developing severe acute graft versus host disease (GVHD) in     haploidentical transplantation.      Purpose: This phase I/II trial is to evaluate the safety and efficacy of fludarabine,     cyclophosphamide and antithymocyte globulin with CD3±CD19 depleted graft from haploidentical     donors in treating patients with aplastic anemia.   "
248276|NCT01105286|"     The purpose of this trial is to compare the anti-psoriatic effect of eight different     formulations of vitamin D analogues using a psoriasis plaque test design   "
248277|NCT01105299|"     The purpose of this study is to characterize and compare the bioequivalence of CJ anastrozole     [CJ Cheiljedang corp., Seoul, Korea] with Arimidex® [AstraZeneca, Wilmington, DE, USA].   "
248476|NCT01107795|"     This is a prospective observational study that will collect outcome data for patients who     choose to undergo transoral tongue base operations for Obstructive Sleep Apnea Hypopnea     Syndrome (OSAHS)as part of their standard of care treatment. This is a data collection study     only and does not provide for evaluations or treatment of OSAHS.   "
248278|NCT01105312|"     RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy     using letrozole may fight breast cancer by lowering the amount of estrogen the body makes.     Giving panobinostat together with letrozole may be an effective treatment for breast cancer.      PURPOSE: This phase I/II trial is studying the side effects and best dose of panobinostat     when given together with letrozole and to see how well it works in treating patients with     metastatic breast cancer.   "
248279|NCT01105325|"     To study compliance with secondary prevention during the first months following discharge     from the cardiac intensive care unit (CIC) of patients experiencing a first episode of acute     coronary syndrome : quantitative compliance over 3 months with the two principal treatments     of the prescription (a statin - rosuvastatin, Crestor® and a platelet aggregation inhibitor -     clopidogrel, Plavix®), using an electronic measure system (intelligent blister pack®);   "
248308|NCT01105702|"     This pilot phase II trial studies how well giving temozolomide, bevacizumab, lithium     carbonate, and radiation therapy works in treating patients with newly diagnosed high grade     glioma.   "
248282|NCT01105364|"     RATIONALE: Diagnostic procedures, such as contrast-enhanced ultrasound, may help measure a     patient's response to treatment with drugs such as sunitinib malate, sorafenib tosylate, or     bevacizumab, and allow doctors to plan better treatment.      PURPOSE: This clinical trial is studying ultrasonography in assessing antiangiogenic     treatment in patients with advanced kidney cancer.   "
248283|NCT01105377|"     This phase II trial is studying how well giving azacitidine together with entinostat works in     treating patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as     azacitidine, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Entinostat may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Giving azacitidine together with     entinostat may kill more tumor cells.   "
248284|NCT01105390|"     This phase II trial is studying how well giving AMG 102 together with pemetrexed disodium and     cisplatin works in treating patients with malignant pleural mesothelioma. Monoclonal     antibodies, such as AMG 102, can block tumor growth in different ways. Some block the ability     of tumor cells to grow or spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Drugs used in chemotherapy, such as pemetrexed disodium and     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving AMG 102 together with pemetrexed disodium and     cisplatin may kill more tumor cells   "
248285|NCT01105403|"     The purpose of this study is to determine whether POL6326 is safe and clinically active to     mobilize hematopoietic stem cells followed by transplantation   "
248286|NCT01105416|"     The aim of the present study is to prevent or delay the initiation of alcohol use among young     adolescents being seen in a pediatric emergency department, by enhancing parental monitoring     and improving parent/adolescent conversations. Previous studies have shown that the pediatric     emergency department is an excellent location for performing prevention interventions. By     targeting individuals and their families in the pediatric emergency department (PED), we are     capitalizing on the opportunity to perform a prevention intervention among a high risk     population when parent and youth may be particularly receptive to the intervention.   "
248287|NCT01105429|"     BMS-820132 is an investigational new drug being developed by BMS for treating Type 2     diabetes. The purpose of this study is to test the safety/tolerability (potential side     effects) of single doses of the investigational new drug, as well as the amount of study drug     in the blood, in subjects with type 2 diabetes.   "
248288|NCT01105442|"     The standard treatment for post operative pain is now bupivacaine + sufentanil. The use of     this combination during fast-track colonic surgery leads frequently to post-operative nausea     and vomiting and limited mobilisation possibilities. Therefore the department anaesthesiology     wants to evaluate the use of a different local anaesthetic: levobupivacaine combined with     morphine on demand. The expectation is that the use of levobupivacaine leads to less side     effects.   "
248289|NCT01105455|"     Gestational diabetes mellitus (GDM) is a condition in which high blood sugar levels occur     during pregnancy. GDM increases the risk of medical complications during pregnancy which may     harm the mother and her baby. Since treating GDM to reduce blood sugar reduces the risk of     harm, all pregnant women are screened for GDM using a glucose challenge test (GCT). We think     that a diet containing low glycemic index foods could help keep blood sugar levels normal     during pregnancy and therefore prevent GDM. Thus, the purpose of this study is to see if a     diet containing low glycemic index foods will reduced blood sugar after the GCT and reduce     the prevalence of GDM in women at high risk for the development of GDM.   "
248290|NCT01105468|"     The volatile content of the exhaled breath gas of mamma carcinoma patients will be chemically     analyzed by proton-transfer-reaction time of flight mass spectrometry.      The goal of the study is to determine typical breath gas components that allow to distinguish     patients with mamma carcinoma from women without carcinoma. Further, the investigators will     test whether these breath gas markers can be used as tumor markers, which change in a typical     manner during the progress of the disease. Finally the data will be investigated for the     presence of marker components, that identify patients who will develop metastasis.   "
248306|NCT01105676|"     To take part in this study you/your child have a vascular malformation, a type of blood     vessel disorder whose cause is unknown.      The investigators will do this by looking at changes in the genes and proteins in the cells     of the malformation as well as normal cells.      The investigators are doing this research because currently there is no known cause of     vascular malformations and no way to know whether or not other health problems will occur in     addition to the malformation. Through this research we hope to create standard methods for     doctors to examine and treat people with vascular anomalies.   "
248291|NCT01105481|"     This study includes two main components: the first screening phase and the second clinical     intervention phase. During the screening phase, subjects with poor response to clozapine are     carefully evaluated by chart-review and clinical assessment. Via chart-review, clinical data     of diagnosis, disease course and previous treatment outcome, and concomitant psychotropic     agents are obtained. Clinical phenomenology, including psychopathology, psychotic and mood     symptoms severity and side effect of psychotropic medication are assessed by clinical     interview and observation, which are conducted by experienced clinicians. Blood sample will     be also obtained from the subjects for measuring the baseline clozapine drug level and     extracting DNA for further analysis. Subjects fulfilling the criteria of treatment-resistant     schizophrenia with poor response to adequate dose and duration of clozapine treatment are     eligible for the clinical trial phase of 14-week randomized, placebo-controlled amisulpride     add-on study. In this phase, subjects are randomly allocated to amisulpride augmentation     treatment group and placebo treatment group. Subjects in the former group will receive     clozapine and amisulpride combination treatment, while in the latter group will receive     clozapine and placebo. Outcomes of clinical efficacy and safety are carefully evaluated by     experienced and well-trained research stuffs in the 14 weeks of clinical study period.      All of the above studies will be conducted in four hospitals, including DOH Bali Psychiatric     Hospital, DOH Tao-yan Psychiatric hospital, and the Ju-Shang Psychiatric Hospital. Subjects     will be recruited from the chronic in-patient settings from these three hospitals.   "
248910|NCT01114191|"     This is a phase 1, open-label study designed to determine the interaction of ketoconazole     with ABT-869.   "
248292|NCT01105494|"     This multicenter, prospective, observational study will evaluate the quality of life and the     factors that influence the quality of life of epoetin beta [Neorecormon] in patients with     renal chronic anemia, who are on dialysis. For each eligible patient data will be collected     for 6 months. Target sample size is 5000-7000 patients.   "
248293|NCT01105507|"     This study will assess the safety, tolerability and efficacy of canakinumab treatment in     Canadian patient diagnosed with cryopyrin-associated periodic syndrome over a period of 18     months.   "
248294|NCT01105520|"     Patients included in the study are treated at the Klinik für Neurochirurgie USZ. The clinical     course is documented at Paraplegikerzentrum Balgrist using validated diagnostic procedures     (e.g. SCIM, ASIA, neurophysiology).      Study aims:      Prognostic value of clinical diagnosis and additional diagnostic procedures? Which parameters     exhibit optimal prognostic power? Differences between tumor/AVM associated lesions and     traumatic lesions? What can we learn for pathophysiology and treatment?        -  Trial with surgical intervention   "
248295|NCT01105533|"     This study will test a new cancer medication to determine if this medication will block blood     supply to a tumor and decrease growth of a tumor. This study will also define the safety     profile and define the safest dose of this new medication for people who have cancer.   "
248296|NCT01105546|"     The study evaluates the efficacy and safety of a prophylactic treatment with recombinant     activated FVII in reducing the frequency of joint bleeds and the development of joint damage     in children with hemophilia A who develop high-titer inhibitors.   "
248297|NCT01105559|"     The purpose of this study is to evaluate the long term immunogenicity produced in children by     the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT     00362336).      Primary Objective: To describe the antibody long term persistence at 3.5 and 4.5 years of age     following a 3 dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™     + Oral poliovirus vaccine (OPV) + Engerix™ B vaccination at 6, 10 and 14 weeks of age and a     booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + OPV at 15-18 months   "
248298|NCT01105572|"     The hypothesis is that use of Internet-connected home biomonitoring of weight, blood pressure     and other indicators, in conjunction with nurse case management, will result in improved     outcome for Medicare beneficiaries with with Congestive Heart Failure; compared to case     management assistance without the biomonitoring device.   "
248299|NCT01105585|"     The purpose of this study was to prospectively compare high-order aberrations between eyes     implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted     with the Tecnis ZCB00 IOL.   "
248300|NCT01105598|"     This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability,     pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with     mild dyslipidemia.   "
248301|NCT01105611|"     The purpose of this study is to compare how safe, tolerable, and effective a novel drug,     raltegravir, is to a commonly used combination, atazanavir/ritonavir, as initial treatment in     HIV/Hepatitis C co-infected injecting drug users on a methadone program.   "
248302|NCT01105624|"     The primary objective of this study is to compare the duration of subject reported     comfortable contact lens daily wear time in subjects with a history and current complaint of     CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to     rewetting drops   "
248303|NCT01105637|"     Burn injuries can affect how well you are able to perform daily activities. The reason this     study is being done is to find out if aerobic exercise helps burn patients recover function,     strength and stamina.      Participants will come to Johns Hopkins Bayview Medical Center, Burn Rehabilitation Gym for     treadmill exercise sessions 3 days per week for 12 weeks. Participants will be tested for     strength and stamina before the start of the 12 week program, at the end of the 12 week     program, as well as 6 months, 1 year and 2 years after the end of the 12 week program.      Patients who recently suffered a burn injury and who were discharged from the hospital in the     past six months may be eligible to participate.   "
248304|NCT01105650|"     This is a single center phase II trial designed to optimize a clinical platform of     lymphodepleting chemotherapy and T-cell suppression to promote the persistence, function, and     expansion of allogeneic natural killer (NK) cells in patients with recurrent ovarian,     fallopian tube, primary peritoneal cancer and advanced metastatic breast cancer.   "
248305|NCT01105663|"     PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This     study will provide data that may allow for improved dosing recommendations in this critically     ill population of children.   "
248585|NCT01109225|"     This study aims to determine whether aldosterone blood levels are predictive of cardiac     remodeling at 6 months following myocardial infarction with ST elevation (STEMI),     independently of conventional predictive factors (size of myocardial infarction, age,     hypertension, etc.) in revascularized patients during the acute phase of MI.   "
248307|NCT01105689|"     Background:      Vitamin D plays a key role in calcium absorption in the gut and in skeletal development.     Vitamin D deficiency is common, affecting an estimated one billion people worldwide,     including developed countries. Vitamin D deficiency causes rickets, the most common     non-communicable disease of childhood. Rickets causes poor growth and skeletal deformities     and, at its most severe, seizures and death. Recent data suggest that children with rickets     have an increased risk for developing diabetes mellitus.      Screening for vitamin D deficiency is not commonly done. It is generally diagnosed only after     symptoms of rickets have developed. Prevention and treatment is simple and inexpensive.     Hence, early detection of vitamin D deficiency through screening would be beneficial. Studies     are urgently needed to validate such screening tests.      Calcium balance is tightly regulated in the body and calcium loss in the urine (measured by     the urine calcium-to-creatinine ratio) is a sensitive indicator of reduced calcium     absorption, such as in vitamin D deficiency.      Objective and Hypotheses. The objective of this study is to evaluate the urine     calcium-to-creatinine ratio as a noninvasive and inexpensive screening test for vitamin D     deficiency. Our hypotheses are 1) that the urine calcium-to-creatinine ratio correlates with     blood vitamin D levels in infants and toddlers at risk for vitamin D deficiency and 2) that     this test can be used to screen for vitamin D deficiency.      Potential Impact. A validated screening tool would allow for the detection of vitamin D     deficiency before the development of rickets, decreasing the morbidity and mortality of this     common disease.   "
248309|NCT01105715|"     The investigators hypothesize that cLDL levels are elevated in RA patients and represents an     important mechanism for accelerated atherosclerosis leading to excess cardiovascular disease     (CVD) in rheumatoid arthritis (RA) patients. The purpose of this study is to improve     understanding of the reasons for increased cardiovascular diseases (such as heart attack and     stroke) seen in patients with rheumatoid arthritis (RA, an arthritis that causes inflammation     and destruction of joints). Specifically, the study plans to determine whether a particular     type of change in proteins in LDL cholesterol (bad cholesterol) known as carbamylation is     an important risk factor for cardiovascular diseases in RA patients. The study will utilize a     case−control study design. A total of 120 subjects (males and females between the ages of 18     and 80) may be enrolled in order to ensure that 100 subjects (50 RA case subjects and 50 age     and sex matched controls) complete the study. Procedures will consist of a single visit for     each subject during which a screening evaluation, an enrollment evaluation, and a single     blood draw will be performed.   "
248310|NCT01105728|"     Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get     resected because of their malignant potential. To minimize the associated surgical trauma     endoscopic endoluminal resection is favorable. Therefore in the current study endoscopic     resection of gastric subepithelial masses is investigated. Since there is a certain risk of     perforation due to the procedure, perforations get closed by placement of endoscopic clips     (over-the-scope-clip [OTSC] clips).   "
248311|NCT01105741|"     Background and Rationale: Inflammatory bowel disease (IBD) is a major burden to individuals     and society. Ulcerative colitis and Crohn's disease (CD) are the 2 major inflammatory bowel     diseases (IBD). They share some pathologic and clinical features but overall their     pathogenesis is not resolved and diagnosis is sometimes difficult. The incidence rates range     from 3.1 to 14.6 cases per 100,000 person year for Crohn's disease to 2.2 to 14.3 cases per     100,000 person years for ulcerative colitis and prevalence ranges up to 201/100,000 for     Crohn's disease and up to 246/100,000 persons for ulcerative colitis.      Powerful biological therapies were recently introduced for the treatment of CD. They offer     superior treatment for the treatment of steroid refractory patients. Interestingly newer     studies suggest that these therapies might also be beneficial if not superior if used at     earlier stages of the disease. But presently limitations of these treatments need to be     considered and biomarkers that could better direct these treatments are urgently needed.      One present limitation is that these new therapies, though being beneficial in a large number     of CD patients, will not be beneficial to all CD patients. Presently treatment responders and     non-responders can not be identified prior to the treatment with the biological adalimumab     representing an important unmet clinical need. Since adalimumab treatment can be accompanied     by serious, potentially lethal, side effects, it would be a major advantage if future     biomarkers could predict whether an individual will or will not respond to one or the other     treatment.      Furthermore with treatments available being associated with high costs to patients and     society, as the treatment with adalimumab is, biomarkers that would help to identify     potential treatment-responders or non-responders would support their targeted use and would     be appreciated by all stakeholders.      Nuclear magnetic resonance (NMR) spectroscopy is a method that generates comprehensive     metabolic profiles from human biofluids, and these metabolomic profiles may be useful to     identify biomarkers with discriminative and predictive power in CD. Thereby amongst other     factors serum metabolites are affected by inflammation and urine metabolites are affected by     gut flora and thus one or a combination of both may be a valuable tool in CD.      Aim: The investigators aim is to identify metabolomic predictors of clinical response to     adalimumab treatment in CD patients in order to direct future treatment to a group of     patients that is expected to benefit most.      Methods: Metabolomic profiling together with the collection of clinical data will be     performed in patients with IBD prior to treatment with biological therapy and for up to 6     month thereafter.      In the study the investigators follow 50 patients with Crohn's Disease, naive to treatment     with biologics. Metabolomic profiling will be performed 1 week prior to the treatment with     adalimumab and then every 4 weeks for 6 month. In order to be reliable and reproducible,     sampling will be performed in the morning after an overnight fasting period. On the days of     serum/urine collection the following data will be collected: CBC, ESR, CRP, Calprotectin,     ASCA/pANCA, IL-10, TNFα, IFNγ, Crohn's disease Activity Index, present medication and OTC,     Dietary and lifestyle history including 24 hour dietary recall, alcohol intake, smoking and     exercise.      Multivariate analysis will be performed to identify patterns in the metabolomic profile that     predict response or non-response to adalimumab treatment.      To summarize, IBD is a major burden to patients and society. Adalimumab treatment is helpful     in steroid refractory patients. Novel biomarkers that help physicians to decide which patient     might benefit from adalimumab treatment may be powerful tools to optimize directing these     powerful but expensive and side effect bearing therapies towards the patient that might     benefit most. Metabolomic profiling may be the tool that helps us to identify these patients.   "
248312|NCT01105754|"     The overall goal of this project is to evaluate whether a multifaceted prompting     intervention, administered in the urban primary care office setting, reduces morbidity among     urban children with asthma. This study builds on our experience with a pilot study in two     urban continuity clinics, in which we found that prompting clinicians about asthma severity     and care guidelines at the time of an office visit resulted in improved preventive care     delivery to inner-city children. This type of prompting program has the potential to     substantially improve care for impoverished children with asthma, and we propose to     establish: 1) whether these findings can be replicated in a similar study including a larger     sample of urban children from different types of practices, and 2) whether the positive     effects can be enhanced by more specific prompting directed towards both the provider and the     caregiver and by providing practice-level supports and feedback. We hypothesize that children     receiving a multifaceted prompting intervention (MPI) will experience less asthma-related     morbidity (defined by symptom-free days at the 2-month follow-up) compared to children     receiving usual care. Our secondary hypothesis is that children receiving the MPI will     receive improved preventive asthma care (defined by guideline-based corrective actions taken     at the index visit) compared to children receiving usual care.   "
248313|NCT01105767|"     This cluster-randomized prospective study will evaluate the effect of hygiene-based     intervention strategies on the incidence of overall SSTI and MRSA-associated SSTI among     military trainees. The proposed interventions used singly or in combination include     standardized training and education, and weekly chlorhexidine showers.   "
248314|NCT01105780|"     The purpose of this study is to assess the safety, tolerability pharmacokinetics (how the     drug is absorbed in the body, how it is distributed within the body and how it is removed     from the body over time) and pharmacodynamics (the effects of the drug) of JNJ-41443532 in     healthy male and female Caucasian and male Japanese participants.   "
248315|NCT01105793|"     The purpose of this study is to determine the safety of topical FP1198 for the treatment of     moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity     of FP1198.   "
248316|NCT01105806|"     Advance care planning involves thinking about choices if the patient becomes sick, and is     important for everyone. It does not matter if the patients are ill or healthy. It is     especially important for people who have diseases that cannot be cured. It allows people to     make sure their wishes are respected if they become very sick or are dying. Thinking about     these issues can be upsetting. But, for many people, it is helpful. This type of discussion     can help the family learn what the patient may want but cannot tell them when these decisions     need to be made   "
248333|NCT01106027|"     The purpose of this study is to test whether a dosing regimen of eculizumab in addition to     standard posttransplant care in positive crossmatch deceased donor kidney transplant     recipients will reduce the incidence of acute humoral rejection (AHR).      Patients included in this study will be those who have demonstrable anti-human leukocyte     antigen (HLA) antibody specific for their deceased donor. It is our hypothesis that blockade     of terminal complement activation with eculizumab at the time of transplant in combination     with our current protocols will reduce the incidence of AHR in recipients of deceased donor     kidney transplants who have anti-donor HLA antibody   "
248317|NCT01105819|"     Critically ill patients often need ventilatory support through a plastic tube connected to a     ventilator. Those patients have a altered microbiological flora in the mouth, oropharynx as     well as throughout the intestine. Bacteria that can cause illness are often found in the     oropharynx in such patients and measures are taken in order to reduce the risk of secondary     infections by those bacteria. In all intensive care patients oral care is provided by the     nursing staff aiming at a reduction of the pathogenic species. This is done by a variety     measures.      Chlorhexidine (CHX) is an antisepticum with a capability to reduce bacterial counts in the     mouth and oropharynx and has been shown to be of value also for intubated patients. It is     used frequently throughout the world.      Ventilator-associated pneumonia (VAP) is a costly rather frequent complication to intensive     care and mechanical ventilation and is usually caused by aspiration of infected secretions     from the oropharynx. CHX has in some studies been shown to reduce the frequency of VAP.      The probiotic bacterium Lactobacillus plantarum 299 has the ability to adhere to the mucosa     throughout the gastro-intestinal tract including the mouth and in our pilot study we found     that L plantarum had better ability to reduce colonisation with enteric bacteria in the     oropharynx than CHX had. Figures not statistical significant so this present study is aiming     to get a larger amount of data.      The procedure was found to be safe Hypothesis: Lactobacillus plantarum is better than CHX for     the reduction of pathogenic bacteria in the oropharynx in intubated mechanically ventilated     patients and consequently has a better potential to reduce the frequency of VAP   "
248911|NCT01114204|"     The purpose of the study is to evaluate the efficacy and safety of intravenous (IV)     ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).   "
248318|NCT01105832|"     40 postmenopausal women, with a non-operated proximal humeral fracture, will be randomized to     standard treatment (physiotherapy) or standard treatment + Forsteo (rhPTH 1-34) during 4     weeks. Follow-up will be at 7 weeks and 3 months including x-ray and DASH score (The     Disabilities of the Arm, Shoulder and Hand) measuring physical function, and pain on a visual     analoge scale (VAS).      Two doctors, blinded to the treatment, will judge the callus formation and healing on the     x-rays and guess the treatment. The DASH score and the pain score will be compared between     the treatment groups.      The investigators hypotheses are that callus formation and healing will be more pronounced     and that patients have less pain and better function in the rhPTH 1-34 group.   "
248319|NCT01105845|"     Background:      - New studies in human genetics have revealed information about genetic connections to memory     and motor behavior. Researchers are interested in investigating the role of genetics in motor     learning, in conjunction with related studies taking place in the Human Motor Control Section     of the National Institute of Neurological Diseases and Stroke (NINDS). Participants in motor     learning studies conducted at NINDS will be asked to provide blood samples for further     evaluation.      Objectives:      - To create a repository of blood samples from patients and healthy subjects who are     participating in NINDS motor learning studies.      Eligibility:      - Individuals between 18 and 100 years of age who are or will be participating in motor     learning research studies at the National Institutes of Health.      Design:        -  Blood draws for genetic testing will usually be done on the same day as the motor          learning study. Participants will provide one blood sample for research.        -  No treatment will be provided under this study.   "
248320|NCT01105858|"     Background:      - Family and twin studies have suggested that genetic factors influence approximately 50     percent of a person's susceptibility to type 2 diabetes. Recently, some of the genes involved     in the development of type 2 diabetes have been identified, in large part by genome-wide     association studies. Certain risk factors for type 2 diabetes, such as obesity and insulin     resistance, are highly inheritable, as are diabetic complications such as diabetes-related     eye and kidney disorders. However, few genes associated or linked with diabetes risk factors     or complications have been conclusively identified, and more research is needed to study     specific genetic factors associated with these aspects of diabetes.      Objectives:      - To identify and characterize genetic variants associated with type 2 diabetes, its risk     factors, and its complications.      Eligibility:      - Individuals at least 18 years of age who are not pregnant or nursing mothers at the start     of the study.      Design:        -  All participants will provide information about family history, ethnicity and ethnic          background, occupation, behavioral risk factors, and other data as requested by the          researchers.        -  In addition to a general health history, participants will provide specific information          about diabetes history, with particular emphasis on date of diagnosis, symptoms,          initiation of insulin therapy, complications, and current medications.        -  Testing procedures will be different for individuals with and without diabetes. Those          without diabetes will have an oral glucose tolerance test, while those with diabetes          will be examined for diabetic complications.        -  Other tests during the study will include the following:        -  Physical examination with measurements of height and weight, waist circumference, blood          pressure, and other tests for individuals who have been diagnosed with diabetes        -  Glucose tolerance test for those who have not been classified as having diabetes        -  Retinal photographs        -  Electrocardiograms        -  Hepatic Ultrasound        -  Blood and urine tests        -  Depending on the results of the examination and laboratory findings, participants may be          asked to return to the clinic for supplemental interviews, physical examinations, or          blood tests, or to arrange referrals for medical evaluation and treatment.        -  Participants who have diabetes will be asked to return for yearly follow-up visits.          Participants who do not have diabetes at the initial examination will be asked to return          for follow-up visits every 2 years.   "
248321|NCT01105871|"     This study is designed to test a specific hypothesis exploring the neurophysiologic     mechanism(s) that underlie the pain- relieving effects of immersive Virtual Reality (VR) as a     non-pharmacologic pain management technique, using healthy volunteers experiencing carefully     controlled thermal and/or electrical pain in the laboratory. Over the past decade, our     research group has performed a series of NIH-funded investigations of VR analgesia - in both     the clinical pain and laboratory pain settings - demonstrating its clinical efficacy and     safety. In the current study we will test pharmacologic manipulation of VR analgesia (with     the opioid analgesia antagonist naloxone). We anticipate that this theoretical work will     provide a foundation for future clinical applications of immersive VR - whether used alone or     in combination with other analgesic agents - and make immersive VR a more effective and more     widely used analgesic tool for the treatment of clinical pain.      Our previous work with immersive VR indicates that its use during a painful event can reduce     subjective pain reports during both acute clinical and laboratory pain by 20-50% [1].     Furthermore, we have shown that effective VR analgesia is associated with reduced     pain-related brain activity that is quantitatively and qualitatively comparable to clinically     relevant doses of systemic opioid analgesics [2]. The laboratory pain protocol proposed in     the current application is identical to the UW HSD-approved protocol used in our previous     studies (#25296 - Reducing Brief Thermal and Electrical Pain). What is specifically     different in the current protocol is the use of naloxone to determine whether VR analgesia     operates through an endogenous opioid-dependent mechanism or not. The results of this study     will not only suggest the mechanism of action of VR analgesia, but also allow us to more     effectively apply immersive VR analgesia in the clinically pain setting through its     thoughtful combination with well-established pharmacologic analgesic techniques, such as     opioid analgesia administration.      The specific aim of this study and the hypothesis it tests are as follows: To determine the     extent to which subjective analgesic effects of VR analgesia are inhibited by opioid receptor     antagonism with naloxone. Hypothesis - VR analgesia will not be inhibited by systemic opioid     receptor antagonism, suggesting that VR analgesia is not mediated by release of endogenous     opiates and/or by activation of opioid-dependent descending central nervous system pathways.   "
248334|NCT01106040|"     Data from this pivotal clinical trial will be used to support a marketing application (i.e.,     NDA) of Navidea's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in     the lymphatic pathway draining the primary site of a tumor.      Multicenter, open-label, within-patient comparative study of Lymphoseek and vital blue dye in     the detection of excised lymph nodes in patients with known melanoma and breast cancer. All     patients will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc     99m and vital blue dye.   "
248322|NCT01105884|"     The purpose of the study is to evaluate the efficacy and safety of different commonly used     dressings for treating diabetic foot ulcers. It is a prospective study recruiting 50 type 2     diabetic patients with diabetic foot ulcers (2-50cm2). All the patients will give written     informed consent prior to getting enrolled in the study. All the patients will be randomly     assigned to one of the five groups of the study namely, saline (control),Biatin Ag (Foam),     Hydrocolloid, Hydrogel and Ceredak. Follow up of the patients will be done until the complete     healing of the wound takes place. All procedures of dressing will be done by an authorized     and certified Podiatric Surgeon of the Institution. Details on the cost incurred and days     required for the wound to completely heal will be recorded for all the patients.      This study will provide the efficacy of all the dressings used for treating diabetic foot     ulcers and also the cost of each dressing. This will help the surgeons for managing the     diabetic foot ulcers in a better and cost effective way, which in turn will reduce the burden     of patients both physically and financially.   "
248323|NCT01105897|"     The aim of this study is to examine the incidence of deeply infiltrating endometriotic     lesions among surgically treated endometriosis patients, and examine the impact of     endometriosis, and its surgical treatment, on severity of pain symptoms, quality of life, and     sexual functioning.   "
248324|NCT01105910|"     To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye.   "
248912|NCT01114217|"     To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron     deficiency anemia (IDA).   "
248325|NCT01105923|"     The aim of this study is to identify patients with problem list gaps and intervene to correct     these gaps by creating clinical decision support interventions that alert providers to likely     problem list gaps and offer clinicians the opportunity to correct them. The investigators     will randomize the clinics that will receive the intervention and formally evaluate the study     after a period of 6 months for improved problem list completeness to determine the     effectiveness of our intervention.   "
248326|NCT01105936|"     Blood-Oxygen-Level-Dependent (BOLD) responses to painful mechanical stimulation of the OA     knee following treatment with four consecutive doses (at 8 hour intervals) on giving     sustained released paracetamol treatment or placebo will be compared. The fMRI and pain     assessments will occur approximately 2-5 hours after taking the final dose.   "
248327|NCT01105949|"     The results of this study will help in the development of a new type of nasal strip for     management of nasal congestion and snoring.   "
248328|NCT01105962|"     This is an observational research study whose purposes are to see:        1. if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or          80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic          Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder).        2. if improvements or worsening of symptoms can be recorded with computerized and written          tests for memory and thinking, and with questionnaires about the subject's quality of          life and health.        3. determine the long-term outcome of the treatment.        4. confirm, in large numbers of study participants at multiple sites nationwide, the strong          positive results obtained in pilot studies   "
248329|NCT01105975|"     The primary purpose of your participation in this study is to help answer the following     research question(s)        -  Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or          rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the          blood fat profile more than statins alone.        -  Whether LY2484595 alone improves blood fats profile compared to sugar pills.        -  Whether LY2484595 interferes with break down or functioning of statins.        -  Whether LY2484595 has any side effects that would not support testing it in future          studies.   "
248330|NCT01105988|"     A standard treatment for glioblastoma is a combination of radiation and the drug     temozolomide. This combination sometimes causing swelling (inflammation) of the brain tissue.     When standard monitoring with MRI or CT scans is done within a few months of finishing     treatment, it may be hard to tell if the scans are showing post-treatment brain inflammation     or tumor growth and worsening of disease. Currently the only way to definitively distinguish     inflammation from tumor growth is biopsy.      However, biopsy is an invasive procedure that is associated with risks. Having a non-invasive     method to distinguish post-treatment inflammation from tumor growth can help improve care for     patients with glioma.      For the PET scans in this research study, the investigators are using a radioactive substance     called FLT (3'-deoxy-3'-[F-18] fluorothymidine), instead of the standard substance FDG     (fluorodeoxyglucose). FLT gets absorbed by cancer cells but not by areas of inflammation.     Because of that FLT may be better than FDG in differentiating cancer cells from inflammation.      An MRI scan will also be done at the same time as each of the 2 FLT-PET scans done for this     research study. The two MRI scans performed will also help give more information about the     patient's tumor that is not routinely provided with a routine clinical scan, such as blood     flow through the tumor or metabolic activity in the tumor. The information from these special     MRI scans may provide more information about the blood supply to the tumor and how this     changes in response to treatment. In addition, the MRI scans along with the FLT-PET scans may     help how to distinguish inflammation due to radiation therapy from tumor growth.   "
248331|NCT01106001|"     The hypothesis of this study is that isolated use of local periarticular levobupivicaine     injection during primary hip arthroplasty would improve post-operative pain control. Patients     were randomised in the operating room to receive either a periarticular infiltration, or a     placebo consisting of Saline. Morphine and analgesic consumption was recorded for each     patient, while the modified McGill pain scale was used to determine the adequacy of analgesia     and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45     patients in the treatment group and 46 controls. The results were assessed after one year,     once all the information from both treatment groups was collected.   "
248332|NCT01106014|"     The AC-065A302 GRIPHON study is an event-driven Phase 3 study to demonstrate the effect of     ACT-293987 on time to first morbidity or mortality event in patients with pulmonary arterial     hypertension.   "
248335|NCT01106053|"     This study is being conducted to evaluate the effects that the drug pramipexole has on mood,     food craving, and other behaviors that may be related to binge eating disorder.   "
248336|NCT01106066|"     To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric     cancer   "
250199|NCT01124838|"     A study comparing the safety and efficacy of adalimumab compared with. placebo in adults with     inactive non-infectious intermediate uveitis, posterior uveitis, or panuveitis.   "
248337|NCT01106079|"     The purpose of this study is to investigate whether tight control of patients with newly     diagnosed psoriatic arthritis (consisting of regular 4 weekly objective assessment of disease     activity and protocol-led intensive treatment) can improve outcome as opposed to standard     care (usually 3 monthly reviews with no objective outcome measures and no protocol for     treatment). The principle hypothesis of this study is that tight control of inflammation in     psoriatic arthritis using a treatment protocol and pre-defined objective targets for     treatment will lead to an improvement in patients' disease activity and a reduction in     radiological joint damage.   "
248338|NCT01106092|"     The purpose of the study is to assess the immunogenicity and safety of three formulations of     GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines     administered concomitantly, when administered as a single booster dose to healthy     poliovirus-primed toddlers aged 12-24 months.   "
248339|NCT01106105|"     The goal of the present study was to objectively evaluate the postural behaviour of type II     obese patients as compared to adults showing a normal body mass index (BMI) in critical     postural tasks.   "
248913|NCT01114230|"     The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK)     of AGS-16M8F administered in subjects with advanced renal cell carcinoma.   "
248340|NCT01106118|"     The primary goal of this international non-interventional study is to investigate the     therapeutic effectiveness of vardenafil (film-coated tablet) in Erectile Dysfunction patients     with the Metabolic Syndrome in daily clinical practice. It will include a large number of     patients with various underlying conditions with different cultural and demographic     backgrounds from different geographic areas.   "
248341|NCT01106131|"     The purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin     combination treatment group is non inferiority compare to pioglitazone and metformin     combination.   "
248342|NCT01106144|"     The main component in the treatment of acute myeloid leukemia (AML) is consist of     anthracycline (such as daunorubicin or idarubicin) and cytarabine. Inter-individual     variability of transport/metabolism of the chemotherapeutic agent and several genetic     pathways involved in the drug action might be associated with different response following     the treatment for AML usually consisted of chemotherapy and/or transplantation. One of     potential pathways involved in the drug action is DNA repair pathway, accordingly single     nucleotide polymorphisms (SNPs) in the DNA repair machinery pathway might be a predictive     marker for therapy outcomes in AML.      Several genes were involved in the DNA repair machinery which are 1) Nonhomologous end     joining (NHEJ) pathway involved in the G1/S phase, 2) Homologous recombinational repair (HRR)     pathway involved in the S/G2 phase. XRCC4, LIG4, MRN and ATM are well known genes involved in     the NHEJ pathway, while MRE11, RAD50, NBS1 (MRN), RAD51, XRCC2, XRCC3, RAD51B, RAD51C, RAD     51D, RAD52 or RAD54 are known to be associated with HRR pathway.      A study suggested that the SNPs in the DNA repair pathway was involved in the susceptibility     of secondary AML developing after chemotherapy or autologous hematopoietic stem cell     transplantation, thus these SNP markers could become a predictive marker for secondary AML.     However, it has never been investigated for multiple candidate pathways simultaneously with     relateively larger number of patients. Accordingly, the current study attempts to investigate     the potential role of the genotype markers in multiple candidate pathways, esp. focused on     the DNA repair machinery, with respect to response following chemotherapy or survival of AML     patients.      Total of over 500 archived samples from the patients diagnosed as acute myeloid leukemia at     the Samsung Medical Center, Seoul, Korea will be included, and genomic DNAs will be extracted     and will be examined for their genotypes of the candidate SNPs involved in the DNA repair     pathways. Then statistical analysis will be pursued for single marker analysis, haplotype     analysis and for the construction of genetic risk model based on the multivariate analysis.   "
248343|NCT01106157|"     The primary purpose of this study is to determine if giving the combination therapy     consisting of Thymoglobulin® (ATG) and Neulasta® (GCSF) to patients with established Type 1     Diabetes (T1D) is safe and secondarily, if the ATG and GCSF will preserve insulin production.   "
248344|NCT01106170|"     The purpose of this study is to determine if a supplement called Provex CV can reduce blood     pressure and other risk factors for heart disease. Heart disease is the leading cause of     death in this country and it is important to identify dietary factors, including supplements,     that can reduce heart disease risk factors. The supplement to be tested in this study is made     of a combination of natural compounds found in plants such as grapeseed extract, green tea,     and quercetin. Each compound individually has been shown to improve blood pressure or reduce     inflammation. We hypothesize that Provex CV will reduce blood pressure and levels of     inflammatory cytokines hypertensive patients with symptoms of metabolic syndrome. This     investigational trial of Provex CV has been approved by the United States Food and Drug     Administration.   "
248345|NCT01106183|"     The goals of our study are to critically evaluate if a healthy population supplemented with     Transfer factor experiences fewer incidences of colds and flu, or experience shorter duration     of illness compared to an identical population taking placebo. In this study we will give     either Transfer factor or a placebo to two groups of healthy adult men and women for a period     of 7 weeks in a double-blind experimental design. The frequency and duration of colds and     flu-like symptoms will be recorded during the course of the study. Saliva samples will be     collected weekly and assessed for salivary IgA secretion rate. Data from this study will     establish the efficacy of Transfer Factor to support a healthy immune system.   "
248346|NCT01106196|"     The purpose of this study is to examine the incidence of acute myocardial infarction (MI)     occurring after an influenza-like illness using linked primary care and disease registry     databases.   "
248347|NCT01106209|"     The purpose of this study is to characterize the time to maturation of neutrophil     extracellular trap(NET) formation capability in polymorphonuclear leukocytes(PMNs) isolated     from newborn premature and term infants as well as infants <1 year of age undergoing elective     surgery. This study will also determine whether NETs contribute to the pathogenesis of     necrotizing enterocolitis (NEC). We hypothesize that NET formation contributes to the     pathogenesis of NEC by inappropriately releasing degradative proteins and tissue destructive     enzymes into the inflammatory milieu of the premature infant gastrointestinal tract following     bacterial translocation. We also hypothesize that the delay in NEC development in premature     infants (3rd - 4th week of life) as compared to at-risk term infants (1st week of life)     results from a developmental delay in PMN ability to form NETs.   "
248348|NCT01106235|"     RATIONALE: Aldesleukin may stimulate lymphocytes to kill melanoma cells. Treating lymphocytes     with interleukin-21 in the laboratory may help the lymphocytes kill more tumor cells when     they are put back in the body. Giving therapeutic autologous lymphocytes together with     cyclophosphamide and aldesleukin may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of giving therapeutic     autologous lymphocytes together with cyclophosphamide and aldesleukin in treating patients     with metastatic melanoma   "
248349|NCT01106248|"     The purpose of this study is to assess whether eribulin mesylate (E7389) has an impact on the     electrocardiogram (ECG) with focus on cardiac repolarization, as measured by QT/QTc interval     as well as through a pharmacokinetic-pharmacodynamic (PK/PD) analysis.   "
248359|NCT01106378|"     The purpose of this registry is to compare the safety and the performance of the NEVO™     Sirolimus-eluting Coronary Stent, once commercially available, to the CYPHER Select® Plus     Sirolimus-eluting Coronary Stent in complex subjects presenting with acute STEMI for primary     intervention, diabetes mellitus or multi vessel disease. The second purpose of this registry     is to evaluate the safety and performance of the NEVO™ Sirolimus-eluting Coronary Stent, once     commercially available and the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in     complex subjects diagnosed with acute STEMI for primary intervention, diabetes mellitus     and/or multi vessel disease.      The data will be collected from subjects treated with commercially available product and     following routine clinical practice. Uniform, complete and accurate data will be collected on     the subject's medical history, peri-procedurally, during the index hospitalization, and     during follow-up.   "
248360|NCT01106391|"     This study is a multi-center prospective, open label, non-randomized investigation of     INCRAFT™ in subjects with abdominal aortic aneurysms.      The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.   "
248350|NCT01106261|"     Patients who have been treated successfully for bowel cancer (colorectal cancer) sometimes go     on to develop nodules of disease in another part of the body. If this disease is found to be     related to the original cancer it is called a metastasis. Some patients develop one or more     metastases particularly in the lungs or the liver.      There is a growing trend to remove lung metastases with an operation, in the belief that this     will help patients live longer, however there have not been any scientific studies to prove     this. There is also very little published information about the side effects of this surgery     and how it affects subsequent daily living. This is a feasibility study to determine whether     it will be possible to conduct a large randomised controlled trial investigating the value of     pulmonary metastasectomy (surgery to remove lung metastases) in patients who have been     successfully treated for colorectal cancer. There is a two stage consent and randomisation     process. Firstly, patients will be invited to consent to having a full range of     investigations to assess their suitability for surgery. If found to be suitable, they will     then be invited to consent to randomisation between active monitoring of their disease or     active monitoring with pulmonary metastasectomy. Patients will be followed up regularly for 5     years to assess their disease status and to measure their quality of life and lung function.   "
248351|NCT01106274|"     Recently, riboflavin (0.1%) and ultraviolet-A (UVA) collagen cross-linking (C3R) has shown     potential to improve the signs and symptoms of bullous keratopathy .The objective of this     study is to demonstrate the effects of C3R to treat bullous keratopathy.   "
248352|NCT01106287|"     This study will evaluate the safety and tolerability of single doses of MK-0941 based on     assessment of clinical and laboratory adverse experiences   "
248353|NCT01106300|"     Each year, 110,000 English/Welsh patients are admitted to Intensive Care Units (ICU). Many     face prolonged disability as a result. Over two thirds have moderate-extreme limitation in     their usual activity a year later, and one-third are severely affected, being unable to     continue most activities, or to live independently. Quite why known- but severe muscle     wasting isn't may play an important role. We hope to find out, measuring the degree of     wasting in patients, and seeking potential causes. We shall also address the mechanism of     wasting, which may reflect an altered balance of activity in muscle growth pathways and those     that break muscle down. We'll do this by collecting data, taking regular blood tests,     scanning the leg muscles with an ultrasound machine, and analysing small muscle samples. In     addition, we'll accurately and objectively measure how impaired these patients become, using     specialist questionnaires, special monitoring equipment, simple walking tests and occasional     special ('Cardio-Pulmonary') exercise tests. We'll try to see how badly activity is limited,     and tease out whether muscle weakness plays a significant role in this. Finally, keeping     muscles working (hard to do when unconscious/drowsy/bed-bound) may maintain muscle mass, so     we'll see whether maintaining muscle activity using painless electrical stimulation will     help.   "
248354|NCT01106313|"     The purpose of this study is to study the relationship between insulin and glucose action and     neuropsychological functioning (memory, attention, general thinking abilities) in persons     with depression.   "
248355|NCT01106326|"     The goal of this pilot study is to implement directly observed therapy with preventive asthma     medications through a partnership with the school nurse (with input and direction from the     primary care provider) to assure that the teen receives guideline based preventive     medications, and provide a motivational interviewing intervention to help the teen transition     to independence with their medical treatment plan. We hypothesize that this community-based     pilot intervention will; 1) be feasible and acceptable among this population and among school     personnel, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and     emergency room / urgent care use for asthma care). We anticipate that enhancing preventive     healthcare for urban teens with asthma through partnerships with schools will yield improved     health, prevention of suffering, decreased absenteeism from school, and reduced healthcare     costs. This new method of preventive care delivery could be sustained within the school     nursing system, and could be implemented in schools nationwide. Further, it could be applied     to other chronic illnesses affecting disadvantaged populations.   "
248356|NCT01106339|"     The purpose of this study is to define subgroups of patients with somatoform disorders due to     DSM-IV by immunological, psychological and genetic characterization.   "
248357|NCT01106352|"     The main purpose of this study is to establish a recommended dose of Alpharadin to be used in     combination with docetaxel in patients with bone metastases from castration-resistant     prostate cancer and to investigate safety and explore efficacy of the recommended dose.   "
248358|NCT01106365|"     Multiple sclerosis (MS) is a chronic-inflammatory autoimmune central nervous system disorder     and a leading cause of neurological disability in younger adults in Western countries.     Besides classic neurological symptoms both depressivity and fatigue are among the most     frequent symptoms in MS, affecting up to 90% of patients at onset or during the course of the     disease. Neither are the psychological and immunological backgrounds of both well understood,     nor are there numerous controlled therapeutic trials which would offer convincing treatment     options for fatigue and depressivity in MS.      Transcranial magnetic stimulation (TMS) has been frequently used to investigate altered     hemispheric and inter-hemispheric connectivity in MS. Recently, first therapeutic trials have     been performed to address specific MS-related symptoms by TMS. Koch et al. demonstrated an     improvement of hand dexterity following repetitive TMS, and Centonze and colleagues showed     reduced spasticity following TMS.      Recently, a specific coil for the stimulation of deeper brain regions including the deep     nuclei was developed, the so-called H-coil. It successfully stimulates deeper (pre-frontal)     brain regions. Stimulation with this coil has been shown to be safe and well tolerated in     healthy volunteers, and in patients suffering from major depression.      The aim of this project is to apply deep TMS with the H-coil to the prefrontal cortex (PFC)     of MS patients. The PFC is the region at which stimulation is aimed in previous depression     studies as this brain region has been shown to play a relevant role in affective disorders.     It is the primary aim of this study, to evaluate the safety and tolerability of deep TMS with     the H-coil in MS patients with fatigue or depressivity.   "
248602|NCT01109446|"     We wish to address the efficacy and safety of Platelet Rich Plasma (blood platelets), a new     treatment for lateral epicondylitis (tennis elbow) and compare this new treatment to either     injection with steroid or saline solution.      All injections are guided by ultrasonography.   "
248362|NCT01106417|"     The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in     subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical     vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level     anterior cervical discectomy and fusion with Anterior Cervical Plate Fixation.   "
248363|NCT01106430|"     This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are     judged by the Investigator to have had an inadequate response to methylphenidate therapy. The     study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.   "
248364|NCT01106443|"     When a patient presents with a thyroid mass, part of the work-up may include a fine needle     aspiration biopsy (FNAB). The results of the biopsy then help plan treatment. If the results     are benign, the management will typically be to follow the nodule. If the results demonstrate     or are suspicious for cancer, such as papillary thyroid carcinoma (PTC), the treatment is a     total thyroidectomy (total thyroid removal). The latest American thyroid association     guidelines for PTC (2009) suggest that in many instances a central lymph node dissection     (CLND) should be performed in conjunction with the total thyroidectomy. This procedure     consists of removing the lymphatic (glandular) tissues surrounding the thyroid itself, as     this tissue may have a propensity for cancer spread. The procedure's necessity has met much     controversy in the last decade, but is becoming more of a standard in thyroid cancer surgery.      When a thyroid nodule FNAB is reported as indeterminate, the treatment strategy is less clear     cut. While a diagnostic hemi-thyroidectomy or therapeutic total thyroidectomy may be in     order, the inclusion of CLND is not clearly defined. In many centers a CLND will be omitted     with surgical management for an indeterminate lesion, while in others, it is standard     protocol. The argument of performing CLND is largely based on the tenet that it adds little     surgical time, cost or risks to the patient. Because the evidence of the prognostic role of     lymph node metastases is limited many would argue that the risk of not performing CLND is     greater than performing CLND. Furthermore, in the event of finding cancer on final pathology,     and thus, having to re-operate in the thyroid/central compartment bed, post-operative     complications may increase. Opponents of CLND argue that there is a paucity of strong     evidence supporting CLND in the improvement of oncologic outcomes and can potentially     increase post-operative low calcium levels or vocal nerve damage However, these     recommendations are based on retrospective level III evidence. Thus the debate continues: is     CLND justified as an adjunct to hemi-or total thyroidectomy in indeterminate thyroid     pathology?      The hypothesis is: CLND in hem- or total thyroidectomy for indeterminate thyroid nodules     will not increase post-operative complications.   "
248365|NCT01106456|"     American Indians and Alaska Natives (AI/ANs) have the highest smoking rates of the major     racial/ethnic groups in the United States, approaching 40% to 50%.1-3 In addition, this     underserved population has very low smoking cessation and abstinence rates. The     smoking-attributable mortality rate of AI/ANs is not only the highest but double that of     other ethnic groups.4 To date, there have been almost no studies that have focused on methods     to encourage smoking cessation among AI/AN smokers and no randomized clinical trials. There     is a desperate need for effective, culturally tailored cessation programs.5, 6 We propose a 2     arm, group randomized clinical trial to be conducted at 2 sites in the Midwest (Kansas and     Oklahoma).      We have begun to address these issues through the creation of the All Nations Breath of     Life (ANBL) smoking cessation program using community-based participatory research methods.     ANBL is group-based and is culturally-sensitive in all program components. It recognizes the     sacred role of tobacco among many AI/ANs and how culture affects smoking cessation among     AI/AN, while still addressing recreational smoking. Our pilot work shows promise for reducing     cigarette smoking in AI/AN smokers, with quit rates of 30% at six months post-baseline,     compared to 8-10% quit rates in other published studies.      All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline or     Bupropion or NRT) then randomized into either the culturally-tailored All Nations Breath of     Life program (ANBL) or Nontailored (NT. ANBL consists of in-person group sessions and     individual telephone calls. We have successfully conducted a pilot study of ANBL and have     found very promising results. At 6 months post baseline, all participants will be assessed     for smoking status and continuous abstinence. We will randomize 28 groups per site (8 smokers     per group) to ANBL or NT for a total sample size of 448 AI/AN smokers.      This study is the first controlled trial to examine the efficacy of a culturally-tailored     smoking cessation program for AI/ANs. In collaboration with AI/AN colleagues in Oklahoma we     designed and successfully piloted the intervention to be culturally-tailored and sustainable     in order to enhance its potential for widespread adoption and ultimate impact among AI/AN     smokers. If the intervention is successful, the potential health impact is significant     because the prevalence of smoking is the highest in this population.   "
248366|NCT01106469|"     The purpose of this study is to investigate the safety, tolerability, food effect as well as     the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the     body and how it is removed from the body over time) and pharmacodynamics (the effects of the     drug) of single and multiple ascending doses of JNJ-41443532 in healthy male participants.   "
248367|NCT01106482|"     This study will evaluate the durability of antibody responses in children and adolescents     after primary immunization with TBE vaccine   "
248368|NCT01106495|"     Shear stress maybe the most crucial local factor affecting atherogenesis. The present study     investigated the effect of exposure to increased shear stress promoted by Enhanced External     Counterpulsation (EECP) on the progression of subclinical atherosclerosis and the underlying     inflammation- related molecular mechanisms   "
248369|NCT01106508|"     This first-in-human dose-escalation study is to characterize the safety, tolerability,     pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in     patients with advanced solid tumors.   "
248370|NCT01106521|"     Women found to have early stage breast cancer will have their cancer surgically removed     followed by radiation treatment to the entire breast, five times per week for several weeks.     The radiation treatment prevents the cancer from growing back but creates skin burns. Several     studies have showed that it is nor necessary treating the whole breast.      The investigators team has pioneered a new therapy realizing the permanent implantation of     tiny radioactive seeds into the surgical cavity in a single one hour procedure under light     anesthesia. Patients live a normal life while receiving the radiation treatment. The results     of a first clinical trial on 67 patients shows that the treatment is well tolerate and     efficient. The purpose of the study is to offer the treatment in several places and to     increase the cohort of patient to 420 to capture rare complications if any.   "
248371|NCT01106534|"     XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives     of this study are        -  To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in          real world settings, and        -  To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT)          initiative. This initiative is designed to evaluate the composite of all death,          myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free          from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and          that have been treated with drug eluting stents (DES) and extended dual antiplatelet          therapy.   "
248372|NCT01106547|"     The purpose of this study is to evaluate the effect of 125 mg methylprednisolone, given     intravenously 60-90 minutes before abdominal surgery,on the postoperative rehabilitation     after abdominal hysterectomy.Sodium Chloride is the placebo. The following parameters are     registered:        1. Pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery.        2. The postoperative use of additional analgesics.        3. Inflammatory parameters before and after surgery.        4. Time until mobilization.        5. Time until discharge.   "
249442|NCT01120899|"     The objective of this study is to investigate the safety and efficacy of minocycline as a     microglia inhibitor in individuals with diabetic macular edema (DME).   "
248374|NCT01106573|"     Diabetes Mellitus (DM) is frequently appearing in patients with cardiovascular disease and     these patients, as a consequence herby, has a lesser prognosis. DM is often related to     increased arterial stiffness and hypertension. The investigators thesis is that DM and     pre-diabetes is prevalent in patients undergoing cardiovascular surgery and to some extend is     under-diagnosed. At the same time the investigators imagine that DM is closely related to the     degree of arterial stiffness, and that these parameters are closely related to a new     biochemical marker, fibulin-1.      The investigators aim to describe the prevalence of type 2 DM and dysmetabolism in patients     admitted to the hospital to undergo cardiovascular surgery and besides that to investigate if     there is a connection between the degree of the dysmetabolism and arterial disease, by     studying arterial stiffness and by measuring a new biochemical marker, fibulin-1, which the     investigators newly have identified. The results of this project will give us a measure for     the quantity of unknown DM in patients undergoing cardiovascular surgery and furthermore tell     us more in terms of the connections between a newly identified plasma arterial marker,     arterial stiffness and diabetes.   "
248375|NCT01106586|"     To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing     fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir     disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of     care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r +     FTC/TDF was selected as the active comparator for this study as it is a preferred protease     inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral     treatment-naive adults.   "
248376|NCT01106599|"     This is an open-label, multicenter, Phase I dose-escalation study to assess the safety,     tolerability, and pharmacokinetics of GDC-0623 in patients with locally advanced or     metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation     stage (Stage I) followed by an expansion stage (Stage II). Stage I will evaluate the safety,     tolerability, and pharmacokinetics of increasing doses of GDC-0623 administered orally on a     21 day on/7-day off dosing schedule.   "
248377|NCT01106612|"     The purpose of this study is to determine whether coronary artery CT scanning or nuclear     stress testing is better at diagnosing chest pain patients with known coronary artery disease     to select appropriate candidates for coronary catheterization and re-vascularization.   "
248378|NCT01106625|"     The purpose of this study is to evaluate the efficacy and safety of 2 different doses of     canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are     receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood     sugar) control.   "
248379|NCT01106638|"     The purpose of this study is to determine whether an intensive, eight session behavioral     intervention is superior to standard care in achieving abstinence from cigarettes in smokers     living with HIV/AIDS.   "
248380|NCT01106651|"     The purpose of this study is to evaluate the efficacy and safety of 2 different doses of     canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2     diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.   "
248381|NCT01106664|"     The primary objective of this study is to evaluate the safety and tolerability of NON-7746 in     healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and     pharmacodynamic profiles of ONO-7746 and to evaluate the food effect on the PK profile of     ONO-7746 when administered with or without a meal.   "
248382|NCT01106677|"     The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared     with sitagliptin and placebo in patients with type 2 diabetes mellitus who are receiving     treatment with metformin monotherapy (i.e., treatment with a single drug) and have inadequate     glycemic (blood sugar) control.   "
248383|NCT01106690|"     The purpose of this study is to evaluate the efficacy and safety of 2 different doses of     canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are     receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar)     control.   "
248384|NCT01106703|"     The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE     in asymptomatic subjects with atopy.   "
248385|NCT01106716|"     The purpose of this study is to determine whether KAI-1678 is effective in the treatment of     postherpetic neuralgia pain   "
248399|NCT01106898|"     This phase II trial is studying the side effects and how well giving cyclophosphamide and     paclitaxel with or without trastuzumab works in treating women with stage I or stage II     breast cancer who have undergone surgery. Drugs used in chemotherapy, such as     cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving monoclonal antibody     therapy, such as trastuzumab, with chemotherapy may kill more tumor cells. Giving these     treatments after surgery may kill any tumor cells that remain after surgery   "
248386|NCT01106729|"     This study will trace the path of a natural plant pigment, (cyanidin-3-glucoside; C3G),     through the human body after consumption. C3G is the most abundant of the naturally occurring     anthocyanin family of plant pigments and is responsible for the red to purple colour of many     fruits and vegetables. Anthocyanins are promoted as being potentially beneficial to     heart-health and also have anti-cancer properties, however little is known about how the body     processes these compounds after they are eaten or how they are cleared from the digestive     system. The investigators study aims to answer these questions and, in doing so, unravel how     they may benefit everyone's health.      In this BBSRC funded study, 8 healthy (18-45y) male participants will be recruited to a one     day feeding study (lasting 8 hours) to establish the routes of clearance of anthocyanins from     the body. After consent has been obtained, participants will be screened to establish their     health (by NHS clinical staff). Eligible participants will be asked to consume a low     anthocyanin diet for 7 days and to attend a study day at the Clinical Research & Trials Unit     (CRTU, University of East Anglia). Participants will attend in a fasted state (at least 8h of     water only) and will be asked to provide a urine (total morning void) and faecal (within the     previous 72h) sample. Participants will then consume a C3G capsule and blood and breath     samples will be collected at regular intervals after consumption (0.5, 1, 2, 4 and 6 hours).     The capsule is roughly the size of a commercial vitamin-C tablet (500mg). Participants will     then return in a fasted state on the following 2 mornings to provide further urine, faeces,     breath and blood samples. Low anthocyanin meals will be provided throughout the study day and     on the following 2 mornings. Participants will be reimbursed for their inconvenience   "
248422|NCT01101334|"     This is a Phase 2 and open-label (subject will know the treatment he or she is receiving)     study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study.      The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of     survival in subjects with advanced non-small cell lung cancer who failed the first treatment.   "
248387|NCT01106742|"     Based on the anti-inflammatory and stabilising effect of the AbM, (Agaricus Blazei Murill)     based mushroom extract AndoSanTM on cytokine release in blood in vivo and ex vivo in healthy     volunteers after 12 days consumption, the aim in this study is to investigate whether same     effect is valid in patients with IBD (inflammatory bowel disease). In addition, calprotectin     an abundant cytosolic protein in neutrophils and a surrogate marker for degree of intestinal     inflammation will be measured in blood and feces of these patients.   "
248388|NCT01106755|"     The aim of this study was to investigate the effects of gait training on ground level,     combining BWS and FES in people following chronic stroke.   "
248389|NCT01106768|"     There is little accurate data in the literature at present on oral problems of hyperactive     children, especially regarding care needs that would justify an assumption oral specific. The     purpose of this study is therefore to have accurate data regarding the risk of caries, other     oral diseases like periodontal disease, trauma, and assess the needs dental care and problems     in cooperation for dental care in a population of children and adolescents with hyperactivity     disorder with attention deficit. Finally, it has recently been described as the sleep     disordered breathing was not uncommon in disorder attention deficit/hyperactivity disorder,     whether snoring and/or apnea. But it is now accepted that some features of facial morphology     favoring pharyngeal congestion occur in individuals with obstructive sleep apnea     (hyperdivergent typology with increased anterior facial height and decreased posterior facial     height, becoming the facial retrognathia, pharyngeal congestion, elongation and thickening of     the soft palate, low position of the hyoid bone). A cephalometric analysis of craniofacial     architecture and relationships with the soft tissue surrounding skeletal structures will     detect if any of these specific characteristics that could promote sleep disordered breathing     are found in disorder attention deficit/hyperactivity disorder prevalence with a particular.   "
248390|NCT01106781|"     This is a descriptive observational study. The primary objective is to explore the EGFR gene     mutation status in early stage NSCLC with adenocarcinoma histology after complete resection.     The patients should be histological confirmed adenocarcinoma of the lung, have received     complete resection and tested for EGFR mutation in regular medical practice.   "
248391|NCT01106794|"     The purpose of this study is to prospectively collect specimens from pediatric patients with     diffuse intrinsic pontine glioma or brainstem glioma, either during therapy or at autopsy, in     order to characterize the molecular abnormalities of this tumor.   "
248392|NCT01106807|"     The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in     reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice     daily applications. The study will also evaluate the safety of the study products using     tolerance and adverse event data.   "
248393|NCT01106820|"     The purpose of this randomized intervention study is to investigate the effects and     biological mechanisms of a supervised 12-week progressive resistance training on fatigue and     quality of life in breast cancer patients during chemotherapy. To determine the effect of the     exercise itself beyond potential psychosocial effects due to attention by trainers or the     group support, patients in the control group have a comparable training schedule (i.e. 60     min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).   "
248394|NCT01106833|"     This study is designed as a combined Phase II/III, randomized, open label, multicenter,     prospective comparative study of sirolimus plus prednisone versus     sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients     will be stratified by transplant center and will be randomized to an experimental arm of one     of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of     sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.   "
248395|NCT01106846|"     Hypothesis: The intraoperative administration of ketamine will result in a 30% reduction in     opiate requirement following endometrial ablation surgery and the intraoperative     administration of ketamine will result in a decreased time to meet discharge criteria in the     PACU following endometrial ablation surgery.      The research question is Does intraoperative administration of ketamine result in decreased     postoperative opiate requirement and time to discharge from the postanesthesia recovery unit     (PACU) following hysteroscopic endometrial ablation.   "
248396|NCT01106859|"     A study in healthy volunteers of the next morning driving performance after     middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid. The     next morning driving performance will be measured by taking a standardized driving test.   "
248397|NCT01106872|"     The purpose of this study is to test the combination of the chemotherapy drugs Gemcitabine,     bevacizumab, and docetaxel with valproic acid to treat patients with metastatic sarcoma.     Valproic acid is used by people who have seizures to prevent seizures from happening;     however, its use in cancer is investigational. This study will help define the proper dosing     of this valproic acid. We will assess the safety of valproic acid with the combination of the     above chemotherapy drugs and check for possible side effects. Valproic acid may improve the     function of the chemotherapy drugs against the cancer.   "
248398|NCT01106885|"     Evaluation of telephone care management intervention designed to improve outcomes among     depressed diabetes patients.   "
248400|NCT01106911|"     The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in     combination with full field digital mammography (FFDM) has the potential to reduce     significantly baseline screening recall rates without a loss in the detection of cancers. The     primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline     screening mammography recall rates in negative examinations by at least 20%.   "
248401|NCT01106924|"     Probiotics administration is associated with health benefits on gut barrier integrity and     immunological functions of the gastrointestinal tract. Recently, probiotics consumption was     proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al.     2009) as well as abdominal fat in human (Kadooka Y, 2010). The mechanisms explaining the     effects of probiotics in weight control are not well understood.      The primary objective of the clinical trial is to investigate whether a consumption of a     probiotic formula when compared to an intake of a placebo, is associated with a greater     reduction of body weight.   "
248423|NCT01101347|"     The purpose of this study is to evaluate safety and performance of the Surpass     Aneurysm-Embolization System.   "
248402|NCT01106937|"     Two studies (Gerlach et al. 2000; Gerlach et al. 2002) described the impact of factor XIII on     the risk of prospective hemorrhage for patients undergoing craniotomy. Since then, factor     XIII is measured and substituted in various centers. Few reports support the idea of factor     XIII being involved in the formation of deep venous thrombosis and pulmonary embolism. In     this prospective observational study, patients undergoing craniotomy for brain tumors or     vascular lesions are investigated concerning the incidence of postoperative pulmonary     embolism in respect of possible risk factors (factor XIII activity levels, standard     coagulation parameters, tumor entity, blood loss).   "
248403|NCT01106950|"     This is a phase II therapeutic study of related donor HLA-haploidentical NK-cell based     therapy after a high dose of fludarabine/cyclophosphamide with denileukin diftitox     preparative regimen for the treatment of poor prognosis acute myelogenous leukemia (AML).   "
248404|NCT01106963|"     Anterior knee pain (AKP) is a common complication following intramedullary (IM) nailing of a     tibial shaft fracture. The purpose of this prospective study was to determine if there is an     association between AKP and nail position. The investigators have analyzed postoperative     outcome results and the possible relationship between AKP according to the visual-analog     scale (VAS) scale, and nail position marked as a distance from the tip of the nail to the     tibial plateau (NP) and tuberositas tibiae (NT), measured postoperatively on L-L knee X-rays.   "
248405|NCT01106976|"     The purpose of this research is to evaluate changes in cholinergic brain activity over time     in subjects with Parkinson disease.   "
248406|NCT01106989|"     The purpose of this pilot study is to explore the potential usefulness of a heated lidocaine     70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with myofascial     trigger points.   "
248407|NCT01107002|"     The purpose of this study is to determine whether embryo transfer on day 3 versus day 5 shows     a significant difference in implantation, clinical pregnancy, live birth, miscarriage and     multiple pregnancy rates among women with at least two previous IVF failures   "
248408|NCT01107015|"     The Mobile Diabetes Intervention Study trial is evaluating a diabetes coaching system, using     mobile phones and patient/ physician internet portals to allow patient-specific treatment and     communication by their primary care physician. We hypothesize that timely information     provided to patients and their physicians can result in reduction of A1c over 1 year.   "
248409|NCT01107028|"     Idiopathic pulmonary fibrosis (IPF) is a devastating disease marked by progressive lung     scarring leading to multiple life-altering sequelae. The over-arching goals of the principal     investigator's research program are to more fully characterize these sequelae and to examine     interventions that might improve them. The hypotheses of this particular study are that     pulmonary rehabilitation (PR) is one such intervention, and that PR will improve the sequelae     of dyspnea and impairments in functional capacity, cognition, mood and anxiety, fatigue, and     quality of life (QOL) in patients with IPF.   "
248410|NCT01107041|"     Investigators are evaluating the use of phone sensor data to estimate behavior, depression     and anxiety.   "
248411|NCT01107054|"     A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.   "
248412|NCT01107067|"     The purpose of this study is investigating the effect of testosterone treatment on     paraoxonase level in male patients with hypogonadotrophic hypogonadism   "
248413|NCT01107080|"     The objective of the proposed research is to develop a clinical-trial-ready device and to     evaluate its practical utility as a routinely used intra-operative tool. Our     multidisciplinary group has previously shown that optical techniques can effectively     discriminate between malignant and non-malignant breast tissues. The proposed technology will     be a multi-channel optical assay device for intra-operative imaging of margins in specimens     excised from patients undergoing breast conserving surgery (partial mastectomy) or     mastectomy.   "
248414|NCT01101230|"     The purpose of this research is to build the evidence base for approval of FDA health claims     related to almonds and cardiovascular disease. A randomized, 2-period, crossover controlled     feeding study was designed to compare the effects of two blood cholesterol lowering diets     that meet the American Heart Association recommendations. The nutrient profiles of the     control diet (no almonds/day) and almond diet (1.5 oz. of almonds/day) are matched for     protein, saturated fat, and cholesterol. The study population consists of two cohorts of 25     men and women with moderately elevated LDL-C. The investigators hypothesize that a     cholesterol-lowering diet designed with almonds confers greater cardioprotective effects than     a cholesterol-lowering diet without almonds on the basis of the LDL-C lowering response,     effect on LDL particle size, abdominal adiposity and vascular health.   "
248415|NCT01101243|"     The purpose of the study is to determine the frequency of UVB radiations necessary to     maintain the Vitamin D level during winter time.   "
248416|NCT01101256|"     The purpose of this study is to determine residual anticoagulatory effects of a prophylactic     or therapeutic fondaparinux treatment i.e. prior to surgery/intervention, after pause of     therapy etc.   "
248417|NCT01101269|"     The purpose of the study is to investigate the effect of a blood pressure medication,     Lisinopril, or similar drugs in that class, on the flow of blood to the kidneys. In this     study, we will compare blood flow to the kidneys in healthy people that do not have diabetes     or kidney disease with people that have diabetes and evidence of kidney disease.   "
248418|NCT01101282|"     This study aims to identify whether the addition of positive expiratory pressure (PEP) mask     therapy to standard medical care improves clinically important outcomes in individuals with     acute exacerbations of chronic obstructive pulmonary disease. It is hypothesized that those     who receive the additional PEP mask therapy will show greater improvements than those who do     not.   "
248419|NCT01101295|"     The primary purpose of the study is to describe by a prospective observational study the     serious adverse events occurring in patients treated off-label by rituximab for Immune     Thrombocytopenia.   "
248420|NCT01101308|"     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10     mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured     at the Wilson, NC facility in the fasted state.   "
248421|NCT01101321|"     The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80     mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured     at the Wilson, NC facility in the fasted state.   "
248425|NCT01101373|"     This study will report on the outcome of a clinical program, operational since 1998, that has     used surgery targeting an emotional pathway in the brain in the treatment of severe     depressive illness that has failed to respond to all other available interventions. Benefit     from surgery was anticipated on the basis that the lesion (bilateral anterior capsulotomy) is     a well established surgical target for treating severe treatment resistant depression.   "
248426|NCT01101386|"     This study's primary objective is to determine if continuous renal replacement therapy (CRRT)     can adequately remove the sulfobutylether-ß-cyclodextrin sodium (SBECD) vehicle from the     blood so that intravenous voriconazole can be utilized in critically ill patients with renal     dysfunction requiring dialysis. Secondarily, the pharmacokinetics of intravenous voriconazole     and its metabolite (UK121-265) and adverse effects of SBECD accumulation will also be     evaluated. The study hypothesis is that CRRT is effective at removing SBECD and allows     patients to receive intravenous voriconazole without the concern of SBECD accumulation.   "
248427|NCT01101399|"     Anaemia and functional iron deficiency are common conditions in patients with lymphoid     malignancies, conditions which reduce significantly the quality of life and increase     morbidity and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been     used, but recently their use has been shown to have a negative impact on overall survival in     different oncology populations. Recently published data suggest that intravenous (IV) iron     can be effective in anaemia treatment, even without ESAs. This exploratory study is the first     clinical project with ferric carboxymaltose (FCM) in patients with lymphoid malignancies: the     data generated may be used for further evaluations of the drug in larger populations. In this     study, 1,000 mg of IV iron as FCM will be administered on the same day or within 24 hours     before or after chemotherapy treatment. The primary objective is to evaluate the efficacy of     FCM in the correction of haemoglobin levels in anaemic subjects with lymphoid malignancies,     undergoing chemotherapy. Secondary objectives aim to describe the safety and tolerability of     FCM, and the effect of FCM treatment on iron status variables in subjects suffering from     lymphoid malignancies.   "
248428|NCT01101412|"     RATIONALE: Antimicrobial solution comprising trimethoprim-sulfamethoxazole, edetate calcium     disodium, and ethanol may help prevent blockages and infections from forming in patients with     central venous access catheters or peripheral venous catheters.      PURPOSE: This randomized trial is studying an antimicrobial solution or saline solution in     maintaining catheter patency and preventing catheter-related blood infections in patients     with malignancies.   "
248429|NCT01101425|"     Rationale: Gathering medical information and tumor samples from patients with male breast     cancer may help doctors learn more about the disease.      Purpose retrospective part: to perform a large international retrospective analysis of     clinical and biological data of male BC patients treated in the participating centers from     1990 to 2010.      Purpose prospective part: to create a registry of men with breast cancer for a period of 30     months (starting early 2014).   "
248430|NCT01101438|"     This study is looking at whether Metformin, an agent that is commonly used to treat diabetes,     can decrease or affect the ability of breast cancer cells to grow and whether Metformin will     work with other therapies to keep cancer from recurring. Health Canada has not approved the     sale or use of Metformin to treat breast cancer, although they have approved its use in this     clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its     use in breast cancer is considered investigational.   "
248431|NCT01101451|"     This randomized phase III trial studies radiation therapy with chemotherapy to see how well     it works compared to radiation therapy alone in treating patients with stage I or stage II     cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays     to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. It is not yet known whether giving radiation therapy together with chemotherapy is     more effective than radiation therapy alone in treating patients with cervical cancer.   "
248432|NCT01101464|"     A trial to compare if one 15 mg under the tongue tablet is equal to three 5 mg under the     tongue tablets of Org 5222 (asenapine) in subjects with schizophrenia or schizoaffective     disorder delivered.   "
248450|NCT01107249|"     Long term follow-up of patients treated for esophageal fistulas with a newer occlusive     self-expanding covered metal stents compared to traditional stents.   "
248690|NCT01110330|"     The purpose of this study is to determine if a new formulation of ketoconazole 2% cream is as     effective as a current formulation of ketoconazole 2% cream (Nizoral) compared with placebo     in treating patients with Tinea pedis, a skin infection commonly known as athlete's foot     that is caused by a kind of mold called a fungus.   "
248433|NCT01101477|"     Flexible bronchoscopy (FB) sedation requires keeping sedative level in a narrow window to     prevent over or under sedation. Sedative drug titration according to subjective adjustment by     individual physician may cause unsteady drug concentration. Target controlled infusion (TCI)     has been provided a precise pharmacokinetic control of propofol, direct control the effect     side, (eg. Brain) concentration (Ce), and been applied in surgical anesthesia and variable     procedure sedation. We designed this pilot study to evaluate the optimal regimen of TCI in FB     sedation.   "
248434|NCT01101490|"     The purpose of this study is to determine changes of right and left cerebral oxygen     saturation and blood flow during nephrectomy in lateral decubitus position.   "
248435|NCT01101503|"     The endothelial dysfunction is the early event in atherosclerosis. The investigator previous     study showed that impaired endothelial function exist in newly diagnosed type 2 diabetes. The     investigators hypothesize that intensive multifactorial therapy including intensive blood     control and intensive hypertension control as well as intensive blood lipids control of 1     year can improve vascular endothelial function. Moreover, the improvement of endothelial     function maintains after 5 years or 10 years of intensive multifactorial therapy, called     Metabolic Memorial Effect of improvement of endothelial function.   "
248436|NCT01101529|"     Delayed nausea is a common problem after high dose chemotherapy for bone marrow     transplantation. This study wants to compare standard prophylactic anti-emetic therapy with     the same treatment plus the drug aprepitant (Emend). The hypothesis is that addition of Emend     will reduce nausea and vomiting.   "
248438|NCT01107093|"     Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered     after the onset of the LH surge on the outcome of the leading ovary follicle:        -  echographic follicle rupture        -  inhibition of follicle rupture        -  luteal phase progesterone levels        -  anovulatory progesterone levels   "
248439|NCT01107106|"     The purpose of this observational study is to assess the safety and tolerability of ellaOne®     in routine conditions of use for emergency contraception in postmenarcheal adolescents and     adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.   "
248440|NCT01107119|"     The ambition of this study is to raise the quality of care for old and chronically ill     patients by establishing a sustainable, systematic prevention and integrated care model for     users of home care services.      In this cluster randomized study the intervention will be carried through in five     municipalities and three general hospitals. The home care units in every municipality will be     randomized to either intervention og control units.   "
248441|NCT01107132|"     In Type 2 Diabetes mellitus patients we will:        1. quantify vasculopathy and blood-retinal barrier (BRB) leakage        2. measure blood-brain barrier (BBB) permeability and neuroanatomical changes        3. correlate BRB pathology with BBB breakdown, inflammatory markers and neuropsychiatric          sequela   "
248442|NCT01107145|"     The current treatment recommendations for P. vivax in pregnant and non-pregnant individuals     are to use chloroquine; in non-pregnant patients this is followed by primaquine to prevent     relapse. As primaquine can not be used in pregnant women, these women remain at risk of     relapse. As there is increasing concern about chloroquine resistant P. vivax in this region,     there is a need to identify alternative treatment options. The artemisinin combination     therapies are recommended for use against P. falciparum infections in pregnant women after     the 1st trimester; additional data are needed to support the use of these drugs against P.     vivax.   "
248443|NCT01107158|"     Despite the fact that a link between cholesterol and the myometrium has been clearly     established, no study investigating aspects of cholesterol metabolism and uterine dystocia     currently exists. This study is a pilot study whose aim is to test the hypothesis that an     association between uterine dystocia and single-nucleotide polymorphisms (SNPs) in the genes     coding for the LXRs.   "
248444|NCT01107171|"     Tang-min-ling pills are made by Chinese herbs extract, and data showed they had antidiabetic     effects on the experimental rats and no obvious toxicity was found.This is a randomized,     doubled blind, dose-paralleled-control multi-centre clinical trial to evaluate the efficacy     and safety of Tang-min-ling pills in the treatment of type 2 diabetic patients and explore     the optimal dosage of Tang-min-ling pills.   "
248445|NCT01107184|"     Recent studies indicate that remote ischemic conditioning can protect the heart and other     organs during cardiac surgery. The investigators aim to investigate whether such a stimulus     can reduce the incidence of atrial fibrillation or other complications following coronary     artery bypass surgery.   "
248446|NCT01107197|"     Pressure ulcers are frequently associated with malnutrition. Previous studies have reported     that nutritional support can improve the healing rate of pressure ulcers but no attention has     been clearly given to the nutritional status of the patient treated. Moreover, other     investigators have suggested the additional healing power of some nutrients. Unfortunately,     previous results have been unpowered by small sample size, poor monitoring of compliance to     treatments and the confounding effect of other nutrients. The investigators aimed to test the     effect and additional benefits of several micronutrients delivered through oral nutritional     support on the healing rate of pressure ulcers in malnourished patients.   "
248447|NCT01107210|"     This study aims to examine the evolution and determinants of physical fitness after stroke.   "
248448|NCT01107223|"     Respiratory tract infections are the most common indication for antibiotic prescribing in     primary care. Several studies have shown a strong relationship between antibiotic use and     bacterial resistance. The aim of this trial was to assess the long-term effect of a     continuous education program on general practitioners antibiotic prescribing behaviour. 170     physicians were included in this study. Physicians randomized in the education group attended     a two days seminar focused on evidence-based guidelines on antibiotic use in respiratory     tract infections. The intervention was limited at physicians level and did not target the     patients.   "
248449|NCT01107236|"     The purpose of this study is to assess the safety of IW-6118 when administered as a single     oral dose to patients undergoing third molar extraction. Efficacy will be assessed in an     exploratory manner.   "
248451|NCT01107262|"     The highly pathogenic avian influenza (HPAI) H5N1 virus arrived in the Middle East in 2005     and has since established itself in local domestic birds and is now considered endemic in     several Middle Eastern countries.Few studies indicate the presence of low pathogenicity avian     influenza (LPAI) viruses of the H9 type among Lebanese poultry and wild birds. These studies     also provide some evidence suggesting that humans exposed to these sick birds are showing     elevated antibody titers against these LPAI H9 viruses.      This study will focus on the following objectives:        -  To determine the seroprevalence of AI in poultry-exposed and non-exposed human          populations.        -  To identify risk factors associated with AI infections in occupationally-exposed poultry          workers.        -  To conduct nation-wide cross-sectional surveillance for AI viruses among domestic birds          in low biosecurity farms and backyard flocks.   "
248452|NCT01107275|"     700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to     receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of     0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for     rabies virus neutralizing antibody determination on day 49. All subjects were randomized to     receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals     in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken     before and after booster for up to one year.Safety and tolerability of the vaccine was     assessed and persistence of immune response up to 1 year after the booster doses.   "
248453|NCT01107288|"     The aim of this study is to investigate the effectiveness of a 6-month music-based multitask     exercises program (Jaques-Dalcroze eurhythmics) in improving gait and balance, and reducing     fall risk in community-dwelling older adults with an increased risk of falling.   "
248454|NCT01107301|"     4.4 million children and adolescents in the United States have been diagnosed with attention     deficit hyperactivity disorder (ADHD) and more than half are treated with medication. Most     ADHD medications are stimulants, which activate the sympathetic nervous system (SNS). SNS     activation is closely associated with vascular functional and mechanical abnormalities.     Therefore, ADHD medications, via instigating SNS activation and altering the hemodynamic     profile, may have untoward effects on the vasculature and increase risk of developing     cardiovascular disease in children and adolescents who use them.      Our overall objective in this study is to determine whether ADHD medication use is associated     SNS activation, endothelial dysfunction, and arterial stiffness in children and adolescents.     We will address this objective by conducting a case-control study and obtain non-invasive     measures of SNS activation, endothelial function, and arterial stiffness in children and     adolescents (8-17 years old) with (using stimulant medication) and without ADHD.   "
248455|NCT01107314|"     In this study we hope to delineate the typical vasoactive mediator response of trauma     patients to shock. We plan to assess serum levels of vasopressin and also catecholamines,     angiotensin, and cortisol during resuscitation of trauma patients to delineate high risk     populations for vasopressin deficiency.   "
248456|NCT01107327|"     Venothromboembolic disease (VTE), which includes deep venous thrombosis (DVT) and pulmonary     embolism (PE), is a severe health problem, effecting 1.5/1000 per year in the general     population. In patients over 60 years of age, the incidence is 1/100 per year. Of the two     million Americans per year who will develop VTE, one third will develop pulmonary embolism     (PE). VTE is usually diagnosed by Doppler ultrasound or contrast venography when present in     the extremities, VQ scan or pulmonary angiography when PE is present. However, there are many     instances when the diagnosis of VTE by conventional modalities is limited. These include     obesity, recent trauma or surgery, the presence of a mass, the presence of clot around     central lines, and clot occurring in the abdomen and pelvis. Furthermore, the differentiation     between new and old clot has evaded all diagnostic imaging modalities, and no existing     modality allows for an accurate delineation of all sites of thrombus within the body. New     approaches to the diagnostic imaging of VTE in complicated cases are needed. The first     hypothesis of this project is that FDG PET/CT can be used to accurately diagnose the presence     and extent of acute VTE, and that it will distinguish new clot from old.      Approximately 20-25% of all new cases of venous thromboembolism occur in known cancer     patients. The risk of VTE is 4-6 fold greater in patients with cancer as those without (8-12%     vs. 2%, respectively, lifetime risk). In many cases, the development of VTE occurs as the     first clinical sign of the cancer, even before it is diagnosed. Among patients presenting     with acute VTE have no obvious cause (defined as idiopathic or unprovoked, as opposed to     secondary VTE), the literature reports that up to 20% (range of reported incidence 7-20%)     may ultimately prove to have cancer, depending on the series and whether the thrombosis is     unifocal or multifocal. Despite the substantial prevalence of occult cancer in patients     presenting with idiopathic VTE, there are no current recommendations that these patients be     screened for the presence of cancer. The second hypothesis of the project is that FDG PET/CT     can accurately be used to screen for the presence of cancer in patients with unprovoked     (idiopathic) acute VTE.      Objectives:      There are two specific objectives to test the hypotheses associated with this project:        1. To establish the sensitivity of FDG PET/CT in the diagnosis of acute VTE.        2. To perform a pilot project to aid in the design of a larger trial to define the          incidence of occult cancer in patients rigorously selected for idiopathic (unprovoked)          VTE, and to investigate the value of FDG PET in the early detection of occult cancer in          this population.   "
248457|NCT01107340|"     This is a multicentre post-marketing prospective study to evaluate performance and clinical     outcomes of AMIIStem primary hip system.   "
248458|NCT01107353|"     The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg     Capsules under fasting conditions   "
248459|NCT01107366|"     To prospectively evaluate the safety and efficacy of the LUPIAE hybrid technique for the     treatment of        -  thoracic or thoraco-abdominal aortic aneurysms        -  thoracic aortic type A dissections 2. to compare the safety and efficacy of the LUPIAE          hybrid technique with historical groups (literature review, other hybrid techniques,          LUPIAE retrospective patients)   "
248460|NCT01107379|"     A prospective, multi-arm, multi-center, observational post-market study of balloon sinus     dilatation in the physician office setting under local anesthesia to treat patients with     chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA     cleared for sale in the U.S.A.   "
248461|NCT01107392|"     This study will evaluate the safety and efficacy of intraprostatic administration of     botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to     benign prostatic hyperplasia.   "
248462|NCT01107405|"     The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic     base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention     of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen     Challenge model and in an environmental model during pollen season. Comparisons will be made     following 2 weeks of dosing.   "
248474|NCT01107769|"     This is a single center randomized observational study that evaluates the cost benefit ratio     between the use of two types of instrumentation in TKA: standard instrumentation vs.     VISIONAIRE™ Patient Matched Technology. This study does not involve treatment or     investigational products, as all components are FDA approved and are commercially available.   "
248463|NCT01107418|"     This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426     administered as 240mg tablets in previously treated patients with metastatic melanoma.     Patients will be randomized to receive one of four dose-levels of RO5185426 [RG7204;     PLEXXIKON; PLX4032] orally twice daily on days 1 to 15 (morning dose). Starting on day 22,     treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until     disease progression. Target sample size is <100 patients.   "
248464|NCT01107626|"     RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the     growth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexed disodium     may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not     yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more     effective in treating non-squamous non-small cell lung cancer.      PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium     alone or in combination after induction therapy to see how well they work in treating     patients with advanced non-squamous non-small cell lung cancer.   "
248843|NCT01113515|"     The purpose of this study is to determine safety and efficacy of a new gel formulation of     Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study     will compare number and types of adverse events occured, rates of wound closure and     percentage of wounds closed in Galnobax treated groups versus placebo group.   "
248465|NCT01107639|"     RATIONALE: Radiation therapy uses high-energy x-rays and to kill tumor cells. Drugs used in     chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. It is not yet known whether giving radiation therapy     together with chemotherapy is more effective with or without cetuximab in treating patients     with esophageal cancer.      PURPOSE: This randomized phase III trial is studying giving radiation therapy together with     chemotherapy, with or without cetuximab, followed by surgery in treating patients with     locally advanced esophageal cancer that can be removed by surgery.   "
248466|NCT01107665|"     This is a Phase II single-arm, open-label, clinical trial evaluating the efficacy and safety     of pazopanib in combination with paclitaxel as first line therapy for subjects with     unresectable Stage III and Stage IV melanoma. Previous cytokine therapy is permitted.     Subjects must have measurable disease per Response Evaluation Criteria in Solid Tumors     (RECIST). Subjects who are not candidates for curative intent treatments are eligible for     this study.   "
248467|NCT01107678|"     There is an epidemic rise in the number of overweight and obese children. Overweight and     obesity in children tracks into adulthood and carries elevated risk of chronic diseases such     as seen with the metabolic syndrome (i.e., elevated glucose, hypertension, etc.). Low levels     of PA and poor nutrition seem to be tightly linked to the increase in overweight and obesity.     A minimal intervention that targets simple strategies for both sides of the energy balance     equation may diminish overweight and obesity. Increasing moderate to vigorous physical     activity and improving nutrition through snacks is a feasible, low cost strategy and can be     disseminated nationally through the YMCA, if successful. Specifically, we expect that     children receiving YMCA PAN will show smaller changes in BMI after 3 years of the     intervention when compared to children not receiving YMCA PAN (i.e. standard, existing YMCA     After School Program or YMCA standard care).   "
248468|NCT01107691|"     This study is designed to investigate the effects of two levels of resistance weight training     on body composition, energy expenditure, and energy intake in men and women. The weight     training will take about one hour to complete. Participants will perform the training 3 days     per week for 9 months in a private exercise room equipped with state of the art equipment and     a personal trainer to help guide you through the exercises.      The project lasts 21 months total with one follow-up visit 1-year from your last training     date. You will be required to stay in the Lawrence area and train 3 day/week over the summer     & holidays.   "
248469|NCT01107704|"     The purpose of this study is to test the effectiveness of a multi-faceted communication     intervention for family members of critically ill patients to reduce the family members'     long-term symptoms of depression and anxiety.   "
248470|NCT01107717|"     Type 2 diabetes is a systemic metabolic disease with significant morbidity and mortality due     to damaging blood vessels. Increased blood sugar level is a hallmark of diabetes and is an     contributes to the development of many of its complications. Multiple defects, e.g. impaired     insulin secretion and impaired insulin action, contribute to the development of the disease.     The aim of this study is to test the efficacy and durability of combination of drugs which     correct the defects that lead to the development of diabetes on achieving adequate and     durable control of blood sugar levels. Achieving adequate and durable control of blood sugar     will prevent many of diabetes complications.   "
248471|NCT01107730|"     The purpose of this study is to determine whether vitamin C is effective in the prophylaxis     of post-operative atrial fibrillation in on-pump cardiac surgery   "
248472|NCT01107743|"     In this survey, to collect the safety and efficacy information of Amlodipine /Atorvastatin     (Caduet® Combination Tablets) in daily medical practice will be examined. In addition, the     necessity of special Investigation and post-marketing clinical studies will be examined,     while investigating unexpected adverse drug reactions during the survey period and     understanding of the status of frequency of adverse drug reactions in daily medical practice.   "
248473|NCT01107756|"     Primary Objective:      To evaluate the incidence and severity of neutropenia in patients being treated for solid     tumours with a Taxotere® based regimen when Granocyte® 34 is being used as a primary     prophylaxis for chemotherapy-induced neutropenia.      Secondary Objectives:      Haematological : To evaluate the incidence and severity of febrile neutropenia (with or     without antibiotics) and anaemia in patients being treated for solid tumors treated with a     Taxotere based regimen when Granocyte is being used as a primary prophylaxis.      Non-Haematological : To evaluate the incidence and severity of the following adverse events:     asthenia, anorexia, myalgia, nail changes and oral mucositis in patients with solid tumours     treated with a Taxotere based regimen; when Granocyte is being used as a primary prophylaxis.   "
248475|NCT01107782|"     The purpose of this study is to determine whether sildenafil is effective and safe in the     treatment of fetal growth restriction.   "
248477|NCT01107808|"     This is a feasibility study to examine the treatment with Metformin, vitamin D with calcium     supplement for insulin resistance in obese, black, female teens. The association of low     vitamin D levels and decreased insulin sensitivity has been established. Thus, the specific     aims of this study are:      Specific aim 1: To examine the effect of an 8-week treatment with vitamin D and calcium     supplementations on diabetes-related risk factors in obese, black, female teens.      Hypothesis 1a: In obese, black, female teens with both insulin resistance and vitamin D     deficiency, treatment with vitamin D and calcium supplementation will significantly improve     measures of insulin resistance and sensitivity (as determined by the homeostatic model     assessment for insulin resistance and whole body insulin sensitivity index measures) when     compared to controls not receiving vitamin D and calcium.      Hypothesis 1b: In obese, black teen females with both insulin resistance and vitamin D     deficiency, treatment with vitamin D and calcium supplementation will significantly improve     measures of cardiovascular disease (decreased BMI and improved triglycerides and LDL) when     compared to controls not receiving vitamin D and calcium.      Specific aim 2: To determine if the addition of Metformin to the 8-week treatment with     vitamin D and calcium supplementations improves diabetes-related risk factors in obese,     black, female teens.      Hypothesis 2a: In obese, black, female teens with both insulin resistance and vitamin D     deficiency, treatment with Metformin, vitamin D, and calcium supplementation will     significantly improve measures of insulin resistance and sensitivity (as determined by the     homeostatic model assessment for insulin resistance and whole body insulin sensitivity index     measures) when compared to standard of care or treatment with vitamin D with calcium     supplementation alone while controlling for dietary intake of vitamin D and calcium.      Hypothesis 2b: In obese, black, female teens with both insulin resistance and vitamin D     deficiency, treatment with Metformin, vitamin D, and calcium supplementation will     significantly improve measures of cardiovascular disease risk (as determined by the decreased     BMI, improved triglycerides and LDL) when compared to standard of care or treatment with     vitamin D with calcium supplementation alone while controlling for dietary intake of vitamin     D and calcium.   "
248515|NCT01108302|"     This cluster randomized community-based trial is designed to test the hypothesis that the     intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor     by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary     Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from     9% to 5%) relative to home births attended by the same type of provider who does not provide     the intervention drug. The study will also document correct use of oxytocin in Uniject,     adverse maternal and fetal events associated with inappropriate use and a number of     indicators reflecting the programmatic feasibility of implementing this intervention.   "
248478|NCT01107821|"     Negative pressure wound therapy (NPWT) has become a powerful tool in wound bed preparation of     complex wounds and is routinely used in various disciplines, including general surgery and     plastic surgery.      NPWT involves the creation of a controlled subatmospheric pressure in the wound bed. The     vacuum is generated by a pump and is distributed over the wound bed by a dressing (mostly a     foam or gauze sponge). The therapy has several positive effects on the wound bed, such as     improved local blood circulation, stimulation of granulation tissue formation and controlled     evacuation of wound exudates. Standard negative pressure applied mostly varies between -120     mmHg and -130 mmHg.A new way of applying NPWT is the Engenex™ system using the Bio-Dome™     Wound Dressing, a specially engineered structure that forms a defined space above the surface     of the wound. This space will maintain its size and integrity in the presence of negative     pressure and wound fluids and thus effectively imposes strain on the underlying tissue. The     material properties of the dressing permit moist wound healing while encouraging efficient     removal of exudates. The contact material will not absorb fluid. It has been clinically shown     that the Bio-Dome™ Wound Dressing is effective at growing granular tissue in the base of a     wound at a safe low negative pressure of -75 mmHg, possibly reducing dressing ingrowth into     the wound bed to a minimum.      Our intention is to evaluate NPWT by means of the Engenex™ pump and Bio- Dome™ Wound Dressing     in 15 patients. Patients with large soft tissue defects will be examined by a plastic surgeon     and if suitable for NPWT they will be treated with the Engenex™ NPWT system.      Before starting NPWT wounds will be evaluated and measured (length, width, depth, volume) if     possible. Digital photos will be made and wound swabs will be taken for microbiological     examination.Dressing changes will be performed twice weekly, on Monday and Thursday or on     Tuesday and Friday. At each dressing change a wound will be re-evaluated and measured.      Other parameters to be noted will be, amongst others: pain, comfort, ease of use,material     used, time needed for dressing change, etc.      The NPWT treatment will be carried on for maximum three weeks. During this period plastic     surgeons will evaluate whether the wound is ready for surgical closure or not.      If surgical closure after 3 weeks is not yet an option possibility exists that NPWT will be     continued.      Every wound will be followed up until complete wound healing after surgical closure.      All patients data will be recorded, secured, evaluated and analysed for both medical     parameters and health economic parameters.   "
248479|NCT01107834|"     HIV-uninfected children born to HIV+ women have low level heart problems at birth which may     predispose them to heart failure, arrythmias and heart attack later in life. The impact of     these heart problems on future heart health is unclear as it is unknown if heart problems in     these children persist, worsen or resolve in pre-pubescence. The objective of this study is     to characterize heart function in HIV-negative pre-pubertal children born to HIV+ women and     exposed to HIV and HAART in utero and compare them to age and gender matched healthy children     born to HIV-negative women. Through this objective we will determine if heart problems in     HIV-negative children born to HIV+ women and exposed to HAART in utero persists, worsens, or     resolves during pre-pubescence.   "
248480|NCT01107847|"     The purpose of this study is the measurement of regional opening and closing pressures of     lung tissue by electrical impedance tomography in lung healthy and patients with acute lung     injury. These values might help the setting of positive endexpiratory pressure during     artificial ventilation to avoid the cyclic opening and closing of alveoli.   "
248481|NCT01107860|"     The primary aim of this study is to continue the investigation of cone beam computed     tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing     a compelling body of evidence incorporating non-contrast CBCT in the study protocol. The goal     is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic     work-up of breast lesions.   "
248482|NCT01107873|"     The purpose of this study is to determine the changes of Dorsalis Pedis Artery Flow Pattern     after Caudal Block in Children: Observational Study Using a Duplex Sonography.   "
248483|NCT01107886|"     The purpose of this study is to determine whether saxagliptin can reduce the risk of     cardiovascular events when used alone or added to other diabetes medications   "
248484|NCT01107899|"     To investigate how platelets recover to normal function in subjects who have symptoms of a     heart attack or unstable angina and who get a loading dose of prasugrel or clopidogrel for     planned coronary angiography.   "
248485|NCT01107912|"     The 5-milligram (mg) maintenance dose (MD) of prasugrel in very elderly patients with     coronary artery disease produces a pharmacodynamic response within the same therapeutic range     as 10-mg MD in non-elderly patients.   "
248486|NCT01107925|"     The 5-milligram (mg) dose of prasugrel in low body weight (LBW) patients with coronary artery     disease produces a pharmacodynamic response within the same therapeutic range as 10-mg dose     in higher body weight (HBW) patients.   "
248487|NCT01107938|"     This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to     that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of     GERD.   "
248488|NCT01107951|"     The purpose of this study is to determine the response rate and response duration with the     combination of low-dose rituximab and high-dose dexamethasone in the treatment of adult     immune thrombocytopenic purpura.   "
248489|NCT01107964|"     The investigators hypothesize that oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline,     Research Triangle Park, NC) will decrease dry-eye related symptoms as well as clinical     markers associated with dry eye disease (Schirmer-1 test values, positive vital staining with     lissamine green, and fluorescein tear break-up time) when compared to administration of     placebo.   "
248499|NCT01108094|"     BCCs are the most common human cancer in the US and affect over 1 million people. There is no     effective drug to prevent basal cell carcinomas of the skin.      We hope to learn if an oral antifungal drug, Itraconazole, might inhibit a marker of     proliferation and a biomarker (tumor signaling pathway) of BCC development.      Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and     has been used for the past 25 years with relatively few side effects. It has been shown in     mice to reduce a BCC biomarker and to reduce growth of BCCs.      Thus, it may reduce BCC growth in humans.   "
248500|NCT01108107|"     This study will investigate        -  the effect of preoperative combination chemotherapy in patients with locally advanced          colon cancer with mutation in the KRAS, BRAF or PIK3CA gene        -  the effect of preoperative combination chemotherapy in combination with biological          treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.   "
248530|NCT01108497|"     We will study gene and protein expression in leukemia cells of children diagnosed with acute     leukemia. We hope to identify genes or proteins which can help us grade leukemia at diagnosis     in order to: (a) develop better means of diagnosis and (b) more accurately choose the best     therapy for each patient.   "
248531|NCT01108510|"     The objective of this study is to evaluate the safety and efficacy of a regimen containing     cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate     (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir     (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.      Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA     level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.   "
248490|NCT01107977|"     Irritable bowel syndrome (IBS) affects as many as 14% of high school-aged students. Symptoms     include discomfort in the abdomen, along with diarrhea and/or constipation and other     gastroenterological symptoms, which can significantly impact quality of life and daily     functioning of patients. Emotional stress appears to exacerbate IBS symptoms suggesting that     mind-body interventions reducing arousal may prove beneficial. Often symptoms can be traced     to childhood and adolescence, making the early manifestation of IBS important to understand.     The current study focuses on young people aged 14-26 years of age with IBS. The study will     test the potential benefits of Iyengar yoga (IY) on clinical symptoms, psychospiritual     functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and     spiritual benefits to practitioners and has been associated with reduced stress and pain.     Through its focus on restoration and use of props, IY is especially designed to decrease     arousal and promote psychospiritual resources in physically compromised individuals.     Sixty-four IBS patients aged 14-26 will be randomly assigned to a standardized 6-week     biweekly IY group-based program (1.5 hour sessions) or a wait-list usual care control group.     The groups will be compared on the primary clinical outcomes of IBS symptoms, quality of life     and global improvement at post-treatment and 2 month follow-up. Secondary outcomes will     include visceral pain sensitivity assessed with a standardized laboratory task (water load     task), and psychospiritual variables including coping, self-efficacy, mood, acceptance and     mindfulness. It is hypothesized that IY will be safe and feasible: with less than 20%     attrition; and the IY group will demonstrate significantly improved outcomes compared to     controls, with physiological and psychospiritual mechanisms contributing to improvements;     clinical treatment gains will be maintained at 2 months following yoga.   "
248491|NCT01107990|"     The investigators are beginning a clinical research study here at UCSF to learn more about     how hearts with single ventricles work. The investigators hypothesize that myocardial strain     , as measured by cardiac MRI,in patients with single ventricles differs from normal hearts.     This abnormality is associated with depressed cardiac power output and impaired exercise     capacity. The study will utilize cardiac magnetic resonance imaging, exercise testing, and     lung function testing to study how the single ventricle heart works so that in the future the     investigators can improve how the investigators care for patients with this type of     congenital heart disease.      The research protocol involves: Cardiac magnetic resonance imaging (MRI of the heart),     exercise tests, and lung function tests. Some of these tests are routinely used to follow     patients with single ventricles. Some of these tests are part of the research protocol. If     you agree to participate in this study, these tests will be performed at UCSF. The results of     the routine tests will be shared with your doctor.      Participation will require approximately 30 additional minutes to the cardiac MRI procedure     to collect the research data. The exercise tests, and lung function tests time commitment     will take about two hours.   "
248492|NCT01108003|"     Rationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth     of certain cancers.      Purpose: This pilot study is studying the side effects of broccoli sprout extract in treating     patients with transitional cell bladder cancer undergoing surgery.   "
248493|NCT01108016|"     The study will answer two questions about women with breast cancer in rural communities:        1. Will they find this support group format utilizing videoconferencing acceptable and          rewarding?        2. Will they report a greater sense of emotional and informational support, and less          depression and traumatic stress, than the control groups of women who wait to          participate until after the first groups have ended?   "
248494|NCT01108029|"     Along with cognitive and psychobehavioural disorders, gait disorders represent a major     problem in the treatment of advanced Parkinson's disease (PD). PD can be considered to be a     hyperglutamatergic disease because dopaminergic depletion induces hyperactivity of the     subthalamic nucleus (STN) and the internal pallidum (GPi), with glutamatergic hyperactivity     of the STN's efferent pathway, i.e., the subthalamopallidal, subthalamonigral and     subthalamo-entopeduncular pathways (projecting to the pedunculopontine nucleus (PPN)). Excess     glutamate in the PPN has also been observed in the 6-OHDA rat model of PD. Reduction of this     glutamatergic hyperactivity within the PPN via the systemic or intra-peduncular     administration of glutamate antagonists improves akinesia in drug-induced murine and primate     models of PD, via the NMDA and AMPA receptors. High doses of memantine (10 mg/kg) improve     locomotion in reserpine- and alpha-methyl-p-tyrosine-treated rats. In humans, the PPN may     play a key role in gait, posture control, axial rigidity and attention. It is also involved     in the gating of sensory information involved in the startle reflex, which can be studied via     prepulse inhibition (PPI) of the blink reflex. At present, two uncompetitive NMDA receptor     antagonists are approved for use in humans: amantadine and memantine. Reviews of the recent     literature on these drugs have identified no published studies specifically on severe gait     and attention disorders in PD. Memantine is a partial blocker of open NMDA channels. The     value of memantine relates to the fact that it decreases excessive glutamatergic transmission     by lowering the synaptic noise due to excessive activation of NMDA receptors. In this     double-blind study, the investigators shall seek to demonstrate the presence or absence of an     effect of memantine on gait and attention disorders. In order to study the interaction     between glutamatergic hyperactivity and the dopaminergic system, the investigators shall     study the phenomena both in the absence of L-dopa and following acute administration of the     latter. Twenty eight volunteer, non-demented, late-stage PD patients displaying severe gait     disorders will receive memantine (20 mg/day) or placebo for 3 months. The investigators     expect to see a reduction in gait and attention disorders, together with an improvement in     the blink reflex with PPI under memantine. This pilot study could subsequently be turned into     a double-blind, placebo-controlled multicenter study.   "
248495|NCT01108042|"     A combination therapy of Docetaxel, Cisplatin und 5-Fluorouracil (= TPF) will be used in     patients with resectable oropharyngeal and cavity of the mouth cancer. To improve the     compatibility of the TPF-induction without decreasing the efficacy the dose will be given on     day 1 and 8 instead of applying the whole dose on day 1 every 3 weeks.      In the phase I-part of the trial the optimal therapeutic dose of Docetaxel and Cisplatin will     be defined.      In the phase II-part the progression-free survival after 2 years will be assessed in patients     treated with the optimal therapeutic dose.   "
248496|NCT01108055|"     We will combine an oral investigational vascular endothelial growth factor (VEGF inhibitor)     called pazopanib which is being studied in kidney cancer will be combined with standard     chemotherapy called taxol in patients with relapsed recurrent urothelial cancer.   "
248497|NCT01108068|"     This is a pilot study of up to 10 patients with Osteoporosis-pseudoglioma syndrome (OPPG)     from the Old Order Mennonite community, who will be given lithium for 6 months and have dual     energy xray absorptiometry (DXA), peripheral quantitative computerized tomography (pQCT) and     lab assessment at baseline and 6 months. Studies in the mouse model of OPPG showed that     lithium normalized their bone strength. Controls (n=20) will be recruited from the Old Order     Mennonite community, to minimize the effects of environmental and lifestyle factors. The     controls will not be given lithium. The age range of participants will be 4-64 years.   "
248498|NCT01108081|"     This project is investigating whether both moderate-intensity physical activity and dietary     weight loss will independently reduce sleep apnea symptoms and improve quality of life.   "
248525|NCT01108432|"     Our overall goal is to advance science related to using the Internet in health services     delivery, and specifically smoking cessation by targeting dental hygienists. Our proposed     intervention is the first Internet-delivered intervention to target the dental microsystem     for smoking cessation-providing access to hygienists and patients.   "
248501|NCT01108120|"     -  Diabetic foot ulcers (DFU) are one of the chronic consequences of diabetes which          constitute the most important cause of non-traumatic amputation of the inferior limbs.          Patients with diabetes are 22 times more likely to have foot ulceration or gangrene than          nondiabetics，while foot ulceration precedes 85% of lower-extremity amputation.        -  Three factors combine to promote tissue necrosis in diabetic feet: ischemia, neuropathy          and trauma. Among them, ischemia peripheral arterial disease may play the important          roles in the development of DFU. Moreover, diffuse vascular disease is the main          characteristics, and thus it becomes difficult for treatment by using arterial bypass or          balloon angioplasty. Therefore, we hypothesized that continuous arterial thrombolysis          may be an effective therapy in diabetic foot. The purpose of this study is to          investigate the effectiveness and safety of continuous intra-femoral artery injection of          urokinase by micro-artery-pump in diabetic ulcers.   "
248502|NCT01108133|"     There is evidence that glucocorticoids have an impact on intrusive memories in patients with     posttraumatic stress disorder (PTSD). Hydrocortisone impairs intrusive memory retrieval     whereas dexamethasone should strengthen intrusions in PTSD. We, the investigators, want to     investigate (1) the effect of these two glucocorticoids on traumatic memories and (2) assess     the neural correlates using the script-driven imagery paradigm in the functional magnetic     resonance imaging (fMRI) scanner. We hypothesize that intrusive memories are less intensive     under hydrocortisone-administration and more intense under dexamethasone-administration     comparing both to a placebo-condition. Regarding the neural activation pattern we expect     higher activation in the hydrocortisone condition in the amygdala, the hippocampus and the     medial prefrontal cortex compared to the placebo-condition and less activation in the     dexamethasone-condition compared to the placebo-condition.   "
248503|NCT01108146|"     To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions)     and overall symptomatology in patients meeting criteria of complex chronic PTSD.   "
248504|NCT01108159|"     We will use new technologies to look at the DNA, RNA, proteins, and metabolites in the     disease-containing blood, bone marrow, or tissue and normal cells from the skin. Our goal is     to analyze all of the genes in the diseased and normal skin sample. By comparing the results     of the diseased sample and normal skin cells and the results of the two types of genetic     information (DNA and RNA), we should be able to identify genetic changes that are important     for the initiation, progression, or treatment response of that particular disorder.   "
248505|NCT01108172|"     The purpose of this study is to see whether a Virtual Ward reduces readmissions after     hospital discharge.   "
248506|NCT01108185|"     The aim of this post-marketing observational study (PMOS) is to describe the relief of     symptoms, tolerability and compliance of treatment with Klacid®SR in a dose 1000 mg once     daily in patients with lower respiratory tract infection or in patients with acute     exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).   "
248507|NCT01108198|"     During last years topical steroid creams have been suggested to be effective treatment for     non-retractable foreskin instead of circumcision.      Aim of this study is to investigate the efficacy, safety and persistence of treatment results     of a medium potent steroid cream in a double-blind, randomized, placebo-controlled study.   "
248508|NCT01108211|"     This is a prospective randomized controlled trial investigating the effect of vibration     therapy on bone mineral density (BMD) and bone quality in AIS subjects suffering from     osteopenia (low bone mass).   "
248509|NCT01108224|"     The purpose of this study is to determine whether an intervention to breast cancer patients     including psycho-education and group psychotherapy can enhance quality of life and survival.   "
248510|NCT01108237|"     This investigation is intended to provide clinical information about alignment using     TruMatch™ and to compare the results to a conventional total knee replacement. TruMatch™ will     be compared to a historical control study, which compares alignment results of computer aided     surgery (CAS) and conventional surgical techniques.      The purpose of this investigation is to determine whether TruMatch™ alignment is non-inferior     to alignment achieved with conventional instrumentation. This investigation will compare long     leg alignment in total knee replacement achieved by the two types of procedures. Radiographic     analysis will be performed by the same independent radiographic reviewer as the historical     control study.   "
248511|NCT01108250|"     This study is to investigate whether variants in the LOC387715 locus and the HtrA serine     peptidase 1 (HTRA1) gene within the 10q26 locus are associated with polypoidal choroidal     vasculopathy and whether they are associated with clinical patterns including angiographic     phenotype in a Korean population.   "
248512|NCT01108263|"     -  After determining if subjects meet the criteria to be included in the study they will be          randomly placed in either Group 1 or 2 and patient will be blinded from randomization          group.        -  Subjects will walk across a pressure plate to determine different areas of high pressure          under the foot. This will be done before the INTEGRA application and at every other          follow-up visit.        -  Both groups will be debrided and have pictures taken in the OR        -  Group 1 will have Integra Flowable Wound Matrix applied onto the wound in the OR and          Group 2 will have the Integra Flowable Wound Matrix applied onto the wound and injected          subcutaneously in the OR.        -  Subjects will be placed in a total contact cast at each visit.      If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the     status of the healed ulcer will be assessed.   "
248513|NCT01108276|"     This is an investigator-initiated prospective, randomized, controlled study.     Hypothesis/Objective: The study will evaluate the rates of wound healing among patients with     lower extremity diabetic wounds comparing two groups of patients. Group 1, the control group,     will be treated with the standard of care treatment of moist wound therapy. Group 2 will be     treated with ConvaTec Engenex® NPWT. Both groups will be treated in the inpatient and     outpatient setting. It is expected that the NPWT device will be an effective therapy that     expedites time to closure and demonstrates a significant decrease in the size and depth of     the wound over the course of the 12 week therapy as compared to the standard of care.   "
248514|NCT01108289|"     This study is designed to test the hypothesis that the intramuscular administration of 10 IU     of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO)     at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative     to home births attended by the same type of provider who does not provide a uterotonic drug.   "
248516|NCT01108315|"     Cancer symptoms due to disease progression or side effects caused by cancer treatment are     prevalent. Most cancer patients are treated in outpatient settings. Patients may be provided     with patient education materials and counseled on anticipated side effects while being     provided with different self-management options and warnings regarding when medical care is     required. Despite these efforts, many people feel set adrift in having to self-manage     treatment and illness related symptoms at home resulting in a sense of burden for the patient     and the caregiver.      When the patient does visit the doctor, they increasingly are asked questions to elicit     information about symptoms and performance using structured questionnaires that are shown to     give reproducible, meaningful, quantitative assessments of how patients feel and how they     function—measures that are called patient reported outcomes or PROs. The questionnaires used     to collect this information are called PRO instruments. The use of PRO instruments is part of     a general movement toward the idea that the patient, properly queried, is the best source of     information about how he or she feels. The goal of using PRO measures is to provide better     information to doctors and patients so that the best treatment for patients can be     determined.      PURPOSE: To reduce the isolation of patients/caregivers from the medical care team and to     improve patient/provider communication and clinical decisions by keeping documented daily     reports of patient symptoms online, having notifications sent to the medical team of moderate     to severe symptoms and by reviewing these reports at clinic visits with the medical staff.   "
248517|NCT01108328|"     The objective of the study is to compare subjective appetite ratings and after-meal and 24     hour blood glucose levels within overweight and obese female subjects consuming either a     standardized 3 day low calorie diet supplemented with a viscous fibre known as PGX     (treatment) or a rice flour (placebo control). Each treatment phase will be 3 days in length     and separated by 3 week washout phase, so subjects will also be acting as their own control.     Subjects will be randomized to either start with the low calorie diet with PGX or the low     calorie diet supplemented with rice flour. We hypothesize that the 3 day LCD with PGX will     elicit an improved appetite score compared to the 3 day LCD supplemented with the rice flour     placebo control.   "
248518|NCT01108341|"     The primary objective of the study is to determine the efficacy, as measured by overall     response (complete response + partial response) of bendamustine in combination with     ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma     (NHL).   "
248519|NCT01108354|"     The aim of the present proposal is to prove that adult attention deficit hyperactivity     disorder (ADHD) patients show lower serotonin transporter (5-HTT) binding using positron     emission tomography (PET) and the selective radioligand [11C]DASB. Specifically, the 5-HTT     binding will be quantified in 20 adult medication-free ADHD patients (50% females) and in 20     age- and sexmatched healthy controls. Investigating untreated adult ADHD patients without any     psychiatric comorbidities will provide the opportunity to estimate the change of serotonin     transporter binding in adult ADHD patients compared to a group of healthy controls. Several     lines of evidence support the hypothesis that serotonergic neurotransmission may, in addition     to dopamine, play an important role in the aetiology of ADHD. So far, no PET study     investigating serotonergic neurotransmission in adult ADHD patients has been conducted,     although alterations in the serotonin system may be substantially involved in the     susceptibility and subtype characterization of ADHD.   "
248520|NCT01108367|"     In men, urinary incontinence (UI) is relatively uncommon, and usually associated with some     forms of prostate surgery. Thus, one of the risks of surgery for benign prostate hyperplasia     (BPH) is postoperative UI. The guidelines of the American Urological Association for BPH     treatment indicate that UI (2~5%) is relevant complications after transurethral prostatectomy     (TURP). Rassweiler et al., based on a review of publications stated that early UI may occur     in up to 30-40% of patients after TURP. Rigatti et al. reported that early postoperative     urgency UI occurred in 38.6% (TURP) and 44% (holmium laser enucleation of the prostate;     HoLEP) of surgically treated patients at 1-month after the surgery. Recently, the follow-up     data for patients treated with HoLEP showed that transient stress UI developed in up to 44%     after HoLEP. Although this alternative surgical treatment such as HoLEP can be performed     safely with minimal complications, patients often face debilitating UI during the     postoperative period before any improvement in micturition parameters occurs. Although this     symptom ameliorates within a relatively short time, it usually cause significant stress and     anxiety to the patient as far as their durations is concerned. In addition to its economic     cost, UI is a distressing condition that has major impacts on a patient's quality of life.     Social withdrawal, isolation, and depression occur in some patients.      Because this problem is usually temporary, there has been little attempt at addressing the     issue. Therefore, there has been no research devoted specifically to transient de novo UI     associated with HoLEP.      1. The aim of the present study was following:        1. to investigate the incidence of transient de novo UI after HoLEP for BPH        2. determine the predictors of early postoperative transient de novo UI.   "
248521|NCT01108380|"     For patient with liver cirrhosis who need to right or extended right hepatectomy, we will     treat with autologous peripheral stem cells transplantation to facilitate liver regeneration.     We will asses liver regeneration by evaluation of liver volume and liver function test.   "
248522|NCT01108393|"     The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of     Obsessive and Compulsive symptoms after 16 weeks of treatment.   "
248523|NCT01108406|"     The objective of this study is to assess the long-term safety and quality of life improvement     of the Sonitus SoundBite Hearing System.   "
248524|NCT01108419|"     The aim of the study is to assess the safety and tolerance of a new fermented food versus a     control product in healthy adults during the 4-week consumption period.   "
248528|NCT01108471|"     We aim to assess a new pulse oximeter which measures continuous hemoglobin concentration     (SpHb) in healthy patients undergoing elective Cesarean delivery (CS). This patient     population often experiences significant blood loss during surgery, and measurements of     surgical blood loss are often inaccurate. We will compare measurements of SpHb with estimated     blood loss during the perioperative period, and laboratory measurements of hemoglobin at set     time intervals during the perioperative and postoperative periods (to evaluate the accuracy     of this device's ability to measure continuous SpHb).   "
248529|NCT01108484|"     A program of exercise, diet and psycho-emotional support could improve some outcomes in     cancer survivors.   "
248533|NCT01108536|"     This study centers around the imaging of internal structures of residual limb by means of     modern radiographic imaging techniques (Dynamic Radiography-DRSA).      The purpose of our research is to further study the behavior of bones and soft tissue of the     socket-stump interface during dynamic tasks such as walking or brisk walking. In the long     term this research could prove a basis for improvements in the general design of sockets for     the new generation of prosthetic devices.   "
248534|NCT01108549|"     To determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy,     sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia     (CFS/FMS).   "
248535|NCT01108562|"     This study will focus on patients undergoing total hip arthroplasty and Loma Linda University     Medical Center & East Campus. These patients will be randomized to receive a low dose     lidocaine infusion or placebo, in addition to the patient controlled analgesia pump. These     groups will be compared to one another statistically to determine which group shows the     safest and most satisfying pain control.   "
248536|NCT01108575|"     A growing body of knowledge has documented that the diaphragm, the primary muscle of     breathing, atrophies and weakens within days of instituting mechanical ventilation support.     Diaphragm weakness has been implicated as a major contributor to difficulty with weaning, or     breathing without ventilator support. This study will test whether instituting a diaphragm     strength training rehabilitation program will reduce the time patients require mechanical     ventilation in a surgical intensive care setting.   "
248537|NCT01108588|"     This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and     Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet     function assays   "
248538|NCT01108601|"     Cisplatin and carboplatin induce ototoxicity manifested as sensorineural hearing loss,     tinnitus, and/or vestibular disturbances. Ototoxicity is induced via damage to inner ear     structures by reactive oxygen species. Previous animal studies demonstrated that     transtympanic injection of Ringer's Lactate (RL) provided near complete otoprotective effect     against cisplatin. The purpose of this study is to determine if transtympanic administration     of Ringer's Lactate via a pressure equalising (PE) tube in patients undergoing platinum based     chemotherapy treatment will prevent tinnitus, vestibular dysfunction and hearing loss     especially at high frequencies. Pre- and post- chemotherapy treatment audiometry will be     measured and statistically analysed for significance.   "
248539|NCT01108614|"     The purpose of this study is to reduce the HIV/HCV incidence among the clients attending     community-based methadone maintenance treatment (MMT) , and to prevent the secondary sexual     transmission from HIV+ clients to their spouse and sex partners, through intensified     comprehensive intervention.   "
248540|NCT01108627|"     Asthma is the most common chronic disease of childhood affecting 6.2 million children between     2 and 18 years of age, and is the most common cause of school absenteeism due to chronic     disease. African American children are 3 to 4 times more likely to be hospitalized for asthma     and 4 to 6 times more likely to die from the disease compared to European Americans. The     economic burden in this country from asthma is enormous, exceeding $16 billion in 2004.     Though there is no cure for asthma, several drugs are available that have been shown to be     generally safe and effective in controlling symptoms. Beta 2 agonists are the most commonly     used asthma drugs. When inhaled these drugs relax cells in the lungs, which helps patients     with asthma breath easier. Two types of beta agonists in use are short-acting beta agonists     (SABA) and long-acting beta agonists (LABA). SABA, like albuterol, are used to provide quick     relief of chest tightening which help patients to breathe easier. Long-acting beta agonists     (LABA) also help patients breathe easier and for a longer period of time. Continued SABA use     (for example, inhale albuterol 3 or 4 times a day) is not recommended, and continued LABA use     is recommended only if used together with inhaled corticosteroids (ICS). ICS are the most     commonly used drug used in asthma that protects against inflammation in the lung. Studies     over the past 50 years suggest that continued use of SABA, LABA, and the combination of     ICS+LABA may worsen asthma in some patients by reducing the effect of the beta agonists,     increasing the rate of asthma attacks, decreasing the ability of the lung to work     efficiently, and death. Recent studies suggest asthma worsening by continued beta agonist use     occurs in individuals with a certain genotype. Genotype refers to form of the protein, called     the beta2 adrenergic receptor (b2AR), in the lung that beta agonists work on. Because of     differences in genetic make up, there are different forms of the b2AR. One form is called the     Arg16 genotype the other form is called the Gly16 genotype. Compared to Gly16 genotypes,     patients with asthma genotyped as Arg16 appear to be more susceptible to asthma worsening     that has been associated with continued use SABA, LABA or ICS+LABA. Most of the studies of     the influence of genotype on asthma worsening associated with beta agonist use have been     performed in adults. The results of a small number of studies suggest children are more     susceptible to asthma worsening from chronic beta agonist use compared to adults, and that     children with the Arg16 genotype are more susceptible to having asthma attacks than children     with the Gly16 genotype. Some evidence suggest that children with asthma should not be     treated with ICS+LABA, yet since 2000, the rate at which children with asthma are switched     from ICS therapy alone to ICS+LABA has increased significantly. The major question posed by     the proposed study is: Does treatment with ICS+LABA compared to ICS alone cause worsening of     asthma in children with asthma genotyped as Arg16 homozygotes but not in Gly16 homozygotes?     The specific aim of the project is to evaluate the safety of ICS+LABA in children with asthma     when separated according genotype. Children with asthma will be screened, be assented and     their care taker (parent, for example) consented. A sample of saliva will be collected from     which genetic material (DNA) will be collected for the purpose of genotyping. A total of 90     European and African American children, 45 Arg16 and 45 Gly16 genotypes, will be treated for     16 weeks. Half of each genotype will be randomly assigned to receive ICS alone for 16 weeks     the other half will receive ICS+LABA. At the end of 16 weeks, those starting with ICS will be     then receive ICS+LABA while those who received ICS+LABA first will then take ICS alone.     Before and once a month during treatment, each participant will visit the clinic to undergo     tests that will assess lung function, how well asthma is being controlled, level of     inflammation and quality of life. The results of our study are expected to have a major     impact on the way children with asthma are being treated with drugs. If the results of our     study show that Arg16 genotypes have worse asthma when they are taking ICS+LABA compared to     ICS alone we will conclude that the safety of combination in children is questionable and     should be tested in a larger population of children to determine if this popular combination     should be used in children with asthma. If the results show that the combination in both     genotypes does not worsen asthma compared to ICS treatment, we will conclude that the     combination is safe to use in children, at least for 16 weeks.   "
248541|NCT01108640|"     The specific aim of this study is to identify the degree of correlation between real time     subcutaneous glucose monitoring and intermittent glucose monitoring using capillary glucose     samples, arterial blood samples and venous blood samples in critically ill surgical patients.     A secondary aim will be to determine the accuracy of real time glucose monitoring.   "
248542|NCT01108653|"     In this study the investigators aim at comparing the effect on quality of life and the     cost-effectiveness of a structuralised sick-leave program compared to usual care sick leave     management in patients after an acute non ST myocardial infarction(NSTEMI).The investigators     hypothesize that a structuralised sick-leave program after an acute NSTEMI is cost-effective     without a negative effect on quality of life compared to usual care management in this     patient group.   "
248543|NCT01108666|"     Seventy two patients are being asked to take part in this research study because they have     been diagnosed with Stage IIIA or IIIB non-small cell lung cancer (NSCLC). This study is     being done to determine the highest safe dose of proton beam radiotherapy and/or study drug     (called Nelfinavir) that can be given with concurrent chemoradiotherapy to patients with     cancer without causing bad side effects; and to develop biomarker for clinical outcome. This     study will be done in two phases. In the first phase, feasibility will be established. We     will follow patients treatment courses and record side effects at the standard proton     radiation dose that can be given together with Cisplatinum + Etoposide or Carboplatin +     Paclitaxel. In the second phase, we will see if it is possible to increase the total proton     radiation dose or study drug without increasing the number of bad side effects while treated     together with chemotherapy drugs.   "
248571|NCT01109043|"     The b.p.m study will be performed to gain the insight in the courses of illness and therapy     in subjects, suffering from hypertension and that have elevated heart rate. This study will     show that a therapy with bisoprolol (Concor/Concor PLUS) or any other blood pressure lowering     (antihypertensive) drug lowers blood pressure (BP) and heart rate and increases the quality     of subjects' life.   "
248544|NCT01108679|"     The purpose of this study is to examine how Buprenorphine, a form of opioid addiction     treatment, changes the ability to think and reason among people addicted to opiates, who are     either HIV negative or HIV positive. In addition, blood samples will be stored for HIV+ and     HIV- individuals who take buprenorphine to study its effect. We hypothesize that the HIV     positive participants will demonstrate significant improvement in thinking and reasoning     ability at 3 and 6 months compared to baseline, but that their thinking and reasoning ability     will still be lower than HIV negative participants. We also hypothesize that the biomarkers     in participants' blood samples will be associated with measures of change in thinking and     reasoning ability.   "
248545|NCT01108692|"     This study investigates if the early detection and treatment of supraventricular arrhythmia     (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.      The primary endpoint investigates the delay to implement treatment in two groups of patients     :        -  Active group: Patients followed by telecardiology.        -  Control group: Patients followed in the conventional manner.      It is assumed that the delay to implement treatment will be higher in the Control group.   "
248546|NCT01108705|"     The purpose of this study is to determine whether brivanib is an effective treatment for     liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy.   "
248547|NCT01108718|"     The purpose of this research study is to determine if a new mattress relieves the symptoms of     fibromyalgia and improves sleep, and if this is the case, whether one type of mattress is     better than the other in doing so.   "
248549|NCT01108744|"     The study goal is to compare the management of increased intra-cranial pressure (ICP) using     3% hypertonic saline vs. mannitol (given in same osmolar loads).      Primary hypothesis:      1. Hypertonic saline will be non-inferior to mannitol in decreasing elevated ICP.      Secondary hypotheses:        1. Hypertonic saline therapy will result with fewer complications than mannitol        2. ICP reduction duration will be longer using hypertonic saline when compared with          mannitol   "
248550|NCT01108757|"     The study will assess the risk of catheter associated urinary tract infection in women     undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic     or placebo at the time of catheter removal. The investigators hypothesize that prophylactic     antibiotics will reduce the rate of infection.   "
248551|NCT01108770|"     To characterize skin properties in male subjects with HED   "
248552|NCT01108783|"     The objective of the study was to determine the efficacy and tolerability of 20 mg of     Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic     Rhinitis.   "
248553|NCT01108796|"     This post-marketing surveillance study is designed to supplement the data on efficacy and     tolerability of Micardis® and MicardisPlus® in patients at cardiovascular risk under general     practice conditions.      The aim of the study is to investigate the effect of a six-month treatment with Micardis® /     MicardisPlus® on blood pressure and the effect of the Lifestyle education tool for weight     reduction on blood pressure control.      In addition, the post-marketing surveillance study will provide information on the effects on     target measurement of the Lifestyle education tool and various laboratory parameters produced     by treatment with Micardis® and MicardisPlus® in an unselected patient population under     general practice conditions.   "
248554|NCT01108809|"     The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood     pressure and its ability to reduce different indicated cardiovascular risk scores. The study     will also evaluate the current antihypertensive treatment pattern in the daily practice among     the patient population at increased cardiovascular risk.   "
248555|NCT01108835|"     Objective: Chronic obstructive pulmonary disease (COPD) is a disease with significant     morbidity and incurs heavy utilization of healthcare resources. The direct cost of hospital     admissions related to COPD is the single largest source of expenditure in the public hospital     system. This study aims to assess whether a comprehensive care programme can decrease the     rate of hospital admissions for COPD patients.   "
248556|NCT01108848|"     The objective of this patient registry is to collect data on the safety of Berinert® in     normal clinical practice in the United States. The patient registry will be maintained for a     period of at least 3 years. The duration of individual patient participation will vary and is     determined by the frequency of hereditary angioedema (HAE) attacks and the patient's need for     Berinert® treatment.   "
248557|NCT01108861|"     This is a prospective, randomized, multi-center study recruiting patients with an in-stent     restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn     endoprosthesis (W.L. Gore & Associates), a heparin-bonded endoprosthesis, is compared with     plain old balloon angioplasty (POBA). In 4 Belgian and 2 German centers a total of 80     Patients will be recruited. Primary endpoint is primary patency at 12 months, defined as no     evidence of restenosis or occlusion within the originally treated lesion based on color-flow     duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and without target     lesion revascularization (TLR) within 12 months.      In comparison to POBA, it is expected that the use of the Viabahn endoprosthesis (W.L. Gore &     Associates) will result in greater 12 month primary patency of treated superficial femoral     artery in-stent restenotic lesions.   "
248558|NCT01108874|"     The purpose of this study is to find the best dose of metaraminol to be used in patients     during elective cesarean sections.   "
248559|NCT01108887|"     RebiSmart™ is a device with an electronic injection log to monitoring adherence to therapy.     Therefore RebiSmart is a tool for administering Rebif in multi-dose cartridges that may     improve patient satisfaction and adherence to therapy. The objectives of this study are to     evaluate adherence, effectiveness and convenience of treatment in subjects with relapsing     multiple sclerosis (RMS) using RebiSmart to self-inject Rebif in a multi-dose cartridge.   "
248560|NCT01108900|"     In the present study, it is planned to observe a population of 100 ED patients treated     previously with udenafil and for whom their physician decided to switch them to sildenafil     because of poor udenafil tolerance and/or poor efficacy.   "
248561|NCT01108913|"     The purpose of this study is to determine whether inhalation of Bimosiamose is safe and     effective in the treatment of patients with moderate to severe Chronic Obstructive Pulmonary     Disease (COPD)   "
248562|NCT01108926|"     The purpose of the study is to look at the levels of three HIV medications: tenofovir,     emtricitabine, and efavirenz in blood after the drug intake has been stopped in order to     understand how long these drugs persist in the blood. The study will specifically look at     blood levels of these three drugs (taken as a 3-in-1 tablet) after taking them every day for     14 days.      This study is not randomised which means that all subjects will receive all study medications     in the same order. You and the study doctor will know which study medications you are taking     at all times during the study.   "
248574|NCT01109082|"     The goal of this study is to evaluate children and adolescents with idiopathic scoliosis who     are undergoing spinal fusion using motion analysis, balance, and outcome questionnaires.     Little research has been done to evaluate how different fusion levels impact walking     patterns, range of motion, posture and balance following spine instrumentation in children     with idiopathic scoliosis. Debate still continues whether posterior spinal instrumentation     with the last instrumented vertebra at or above Lumbar 3 (L3) will provide sufficient spine     correction, greater motion, and better posture and balance when compared to a child with     instrumentation at Lumbar 4 (L4). Furthermore, how does the spine fusion endpoint (last     instrumented vertebra) impact quality of life, participation, and impairment in children and     adolescents with idiopathic scoliosis and how do they compare to healthy age-matched peers.     The goal of this study is to compare these two end points using gait analysis, postural     stability, and outcome tools with the hopes of providing better clinical care to children     with idiopathic scoliosis.   "
248844|NCT01113528|"     To evaluate the efficacy of systemic administration of omega 3 PUFA plus low dose aspirin as     an adjunctive therapy to regenerative modality of grade II furcation defects in periodontitis     patients.   "
248563|NCT01108939|"     Anemia is still a main public health problem in sub-Saharan Africa. Anemic women have an     increased maternal and perinatal mortality and anemic adults have diminished work capacity.     In sub-Saharan Africa, the etiology of anemia is multifactoral; the major causes are low     dietary bioavailability and chronic parasitic infections such as malaria. These causes are     likely to interact because infection and infection-associated inflammation may impair the     utilization and absorption of iron. Therefore, the control of parasite infections may be     important to improve iron bioavailability from foods.      Malaria infections are endemic in northern Benin. To investigate the contribution of     asymptomatic malaria (a positive blood smear for malarial parasites but without clinical     symptoms of fever, headache or malaise) to anemia, we are planning a human iron absorption     study in Benin. We will recruit adults with asymptomatic malaria infection. The iron     absorption and utilization of the study subjects will be studied while infected, then they     will be treated to clear their infections, and then iron absorption and utilization will be     restudied. Iron absorption will be determined by incorporation of labeled iron into     erythrocytes, 14 days after the administration of a test meal containing labeled iron (stable     isotope technique). Subjects will be men and non-pregnant, non-breastfeeding women with a     body weight < 65 kg and between the age of 18 - 30 years.      The results of this study will provide important information on the influence of malaria     infections on iron absorption and utilization in humans. The study will provide insight into     the potential necessity of malaria control to ensure iron bioavailability from foods in     developing countries.   "
248564|NCT01108952|"     Background: While treatment for pediatric cancer has improved significantly over the past 40     years, the neurotoxic side-effects of the chemotherapy agents themselves are now being     recognized. Two drugs suspected of having acute impact on memory performance in children are     methotrexate (MTX) and steroids (GCs). In addition, new evidence suggests that this     neurotoxicity might actually protect these children from traumatization.      Working hypothesis and aims: This project aims to examine the acute impact of MTX and GC     chemotherapy on memory performance in children and young adults with cancer, and the     subsequent impact on the development of traumatic symptoms. We hypothesize that MTX and GCs     will each produce acute declines in memory performance and that children with greater     reductions in memory performance will have fewer traumatic symptoms.      Methods: The investigators will recruit 45 children being treated with MTX or GCs at Dana     Children's Hospital. To determine acute impact on memory, a battery of memory tests will be     administered before and after a cycle of MTX and before and after a cycle of GCs. In     addition, traumatic symptoms will be assessed at each post-chemotherapy evaluation point     Expected results: The investigators expect poorer memory performance after MTX and after GCs     and that these performance declines will correlate with lower rates of traumatic symptoms.      Importance: The immediate impact of MTX and GCs on memory is not well known, especially in     children. In addition, recent findings have led us to hypothesize that chemotherapy-induced     deficits in memory function would paradoxically protect these patients from the     traumatization often associated with cancer and its treatment. The proposed study will test     this novel hypothesis for the first time.   "
248565|NCT01108965|"     The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in     hydrocephalic shunts.      The ultrasonic sensor will measure cerebrospinal fluid drainage in hydrocephalus patients     with external ventriculostomies and extra-ventricular drainage systems. The sensor     measurements will be compared with the volume of fluid collected by the drainage bag.      After a 24-hour measurement period, the doctor will change the drainage bag position to     simulate the patient sitting up and leaning back, to see if this temporarily stops flow     through the drainage line.      This data will show whether the sensor accurately measures typical drainage flows seen in     hydrocephalus patients. This research will help develop an implantable flow monitor for     pediatric hydrocephalus patients.   "
248566|NCT01108978|"     The purpose of this study is to evaluate the Efficacy and Safety of Dehypotin® in the     Patients with Type 2 Diabetes Mellitus or Cardiovascular Disease. Eligible patients will be     randomly assigned to 1 of 2 arms, either Dehypotin® or placebo, and will receive the diet     advisement throughout the study.   "
248567|NCT01108991|"     Chronic obstructive pulmonary disease (COPD) is a common condition associated with major     disability. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and     is cost saving, but fewer than 2% of patients have access to these programs. New methods of     PR are needed to increase access of patients with COPD to these established benefits. To     address this gap we propose a novel physical activity self-management (PASM) program based on     an evidence-based physical activity intervention designed to increase physical activity and     quality of life. Key components of the program include tailored telephone counseling, a     workbook, and computer-assisted telephone follow-up. We will test the following two     hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically     significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire     [CRQ] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM     program is more cost-effective compared to the UC. The project addresses a major gap in the     current management of COPD and may provide a novel, cost-effective strategy for improving     functional performance and health status.   "
248568|NCT01109004|"     The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus     maintenance therapy versus the strategy of single autologous transplant plus consolidation     therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy     or single autologous transplant plus maintenance therapy as part of upfront treatment of     multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in     all arms.   "
248569|NCT01109017|"     This study is conducted in Japan. The aim of this observational study is to collect     information about the safety and efficacy of Norditropin® long-term treatment of growth     hormone deficiency in adults.   "
248597|NCT01109381|"     At present, triple therapy is recommended by various guidelines for the treatment of     Helicobacter pylori (H.pylori) infection. Recent studies have shown increasing resistance of     H.pylori to commonly used antibiotics used in triple therapy. This study explores a     non-antibiotic treatment regime for H.pylori that uses lauric acid as the primary     anti-microbial agent. The study hypothesis is that Lauric acid works synergistically with     omeprazole following administration of a mucolytic agent to kill H.pylori topically in the     stomach.   "
248575|NCT01109095|"     This study is for patients that have a type of brain cancer called glioblastoma multiforme     (GBM).      The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancers. This research study combines two different ways of fighting cancer:     antibodies and T cells. Antibodies are types of proteins that protect the body from     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special     infection-fighting blood cells that can kill other cells, including cells infected with     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with     cancers. They have shown promise, but have not been strong enough to cure most patients.      The antibody used in this study is called anti-HER2 (Human Epidermal Growth Factor Receptor     2). This antibody sticks to GBM cells because of a substance on the outside of these cells     called HER2. Up to 80% of GBMs are positive for HER2. HER2 antibodies have been used to treat     people with HER2-positive cancers. For this study, the HER2 antibody has been changed so that     instead of floating free in the blood it is now attached to T cells. When an antibody is     joined to a T cell in this way it is called a chimeric receptor. These chimeric receptor-T     cells seem to be able to kill tumors like GBM, but they don't last very long and so their     chances of fighting the cancer are limited. Therefore, developing ways to prolong the life of     these T cells should help them fight cancer.      We found that T cells work better if we also attach a protein called CD28 to the HER2     chimeric receptor (HER2-CAR). In this study we placed this HER2-CAR into T cells that were     pre-selected for their ability to recognize Cytomegalovirus (CMV). This virus exists in most     people. These CMV-specific cytotoxic T cells (CMV-T cells) will be more active since they     will react to the virus as well as to tumor cells. These HER2-CD28 CMV-T cells are an     investigational product not approved by the Food and Drug Administration.      The purpose of this study is to find the largest safe dose of HER2-CD28 CMV-T cells, to learn     what the side effects are, and to see whether this therapy might help patients with GBM.   "
248576|NCT01109108|"     The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary     care clinic at Boston medical center on the serotype specific carriage of Streptococcus     pneumoniae in children < 5.      Specifically the investigators will measure the decline in vaccine serotypes, the proportion     of children receiving vaccine required to achieve 50% reduction in serotype specific carriage     and the correlation between immunogenicity of the specific serotypes and decline in carriage.     The study has been extended to complete 5 years of surveillance to determine the new SP     serotype distribution at the time presumably a new equilibrium has been achieved.   "
248577|NCT01109121|"     This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study     to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients     with hyperuricemia and moderate to severe gout.   "
248578|NCT01109134|"     The aim of this randomized trial is to compare the efficacy of high dose tirofiban     administered as either an intracoronary bolus alone or as an intravenous bolus followed by a     maintenance infusion with respect to microvascular perfusion and long term left ventricular     infarct size, volumes and function.   "
248579|NCT01109147|"     After an initial screening visit, including an assessment of psychiatric disorders, patients     stabilized on antipsychotic medication (aripiprazole or risperidone) for at least 6 weeks and     control subjects will undergo an assessment using functional magnetic resonance imaging     (fMRI) of the differences of patterns of brain activation during an emotional task   "
248580|NCT01109160|"     This study investigates the role of azithromycin treatment for lymphocytic     bronchitis/bronchiolitis after lung transplantation.   "
248581|NCT01109173|"     The purpose of this study was to assess the safety and efficacy of an investigational eye     drop intended for the prevention and treatment of inflammation (swelling and redness) and     pain in the eye after cataract extraction.   "
248582|NCT01109186|"     BK virus infections are very frequent during months following a kidney transplantation: a     viral reactivation is observed for almost 50% of patients during first year. This     reactivation leads to a viremia for 10 to 15% of patient during this same period. The most     frequent complication is interstitial nephritis for 2 to 8% of patients (27 patients     representing 2.7% during 6 years in Nantes).      An intensive et persisting viral replication, assessed by detection of high blood viral load,     could evolved to a viral nephropathy which lead to a very pejorative functional issue for the     graft.      Biological follow-up of these infections lay on the measures of viral load. Their positivity     must alert the physician and lead him to modulate immunosuppressive treatment.      Actually, there is no real consensus about the modalities of pharmacological     immunosuppression decrease (decrease dose or change of molecule).      Specific lymphocytic anti-BKv evaluated on several cohorts of patients permit to prove:        -  weakness of immune cellular response for patient with high viremia        -  increase of this response when viral load decrease These studies laid on detection of          INFg synthesis by Elispot after stimulation with viral antigens and in vitro cellular          expansion.      New prospective and longitudinal data comparing the immune cellular response (systematic and     early) after graft between patients controlling or not BKv infection are necessary to improve     the comprehension of illness natural history.      The investigators propose to enlarge the investigation of anti-BKv immune cellular response     to other functions than IFNg synthesis in the aim of detecting the eventual role of     polyfunctional lymphocytes for infection control. Furthermore, the investigators propose to     identify better diagnostic and prognostic makers.   "
248583|NCT01109199|"     This 18 week, randomized, double blind, placebo controlled trial will examine the effects of     thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight     loss, body composition, and compliance in overweight and moderately obese female.      The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a     14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the     rice flour supplementation of the LCD.   "
248584|NCT01109212|"     The purpose of this study is to determine whether bindarit is effective to reduce     albuminuria, compared to placebo, in nephropathic patients treated with irbesartan, as a     background therapy.   "
248596|NCT01109368|"     This repository will establish for the first time a system to carefully assess and monitor     over time the general health and the amount of cholesterol in the arteries of U.S. children     and adults with homozygous familial hypercholesterolemia (hoFH). Patients with this very rare     disorder have very high blood levels of cholesterol from birth due to the inheritance of an     abnormal gene from each parent. As a result, if untreated, heart attacks and sudden death     occur in childhood. Treatments such as LDL-apheresis and liver transplant will lower the     cholesterol level, but the best treatment and the best way to monitor the effect of the     treatment on the arteries are unknown. The collection of clinical data and blood for analysis     of known and yet-to-be discovered markers and predictors of arterial disease will yield new     information about the natural history of the disorder and response to treatment. The     repository will greatly aid the development of specific protocols that seek to learn more     about this disease and new therapies.   "
248586|NCT01109238|"     The investigators are studying new ways to make treatment decisions for these types of     cancer. Technologies at the Van Andel Research Institute (VARI) are available to determine a     tumor's molecular makeup (gene expression profile). This technology (called Xenobase) is     being used to discover new ways to understand cancers and potentially predict the best     treatments for patients with cancer. The researchers at VARI have filed a patent on the     Xenobase and the specific network analysis method that the investigators will be using as     part of this study.      A specimen obtained from the tumor during a recent surgical, biopsy, or bone marrow procedure     will be sent to the Van Andel Research Institute. Researchers will attempt to identify the     molecular makeup within the specimen, as well as in blood and urine samples in patients with     aggressive and/or refractory cancer. This additional testing is different than the routine     tests currently performed at the hospital for the evaluation of cancer.      The goals of this part of the study are: To determine if the investigators tumor board     committee (at minimum a panel of 3 oncologists and 1 pharmacist) can use patient specific     cancer cells to make real-time treatment decision using patient specific genetic information,     and predicted therapies generated in the Xenobase report.   "
248587|NCT01109251|"     The study HIPPOCRATE is a prospective open comparative study with a control group.      The objective of this study is to show that an optimization of the caring of non controlled     hypertended patients following a CVA (including a preliminary Tensional auto-measure (TAM) at     the follow-up visit, an education of the patient with a decision support tree for the     generalist and/or a visit in the multidisciplinary AHT department), allow to obtain a better     tensional control copared to the usual caring.   "
248588|NCT01109264|"     To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil     for initial treatment of chronic lymphocytic leukemia   "
248589|NCT01109277|"     Objective: To develop an evidence-based strategy for assessing the risk of significant     hyperbilirubinemia in healthy term and near-term (late-preterm) neonates.      Hypothesis: A stepwise strategy which combines clinical parameters and serial non-invasive     transcutaneous bilirubin (TcB) values could reliably predict significant neonatal     hyperbilirubinemia.      Methods: Data from neonates >34 weeks' gestation included in the registry for neonatal     hyperbilirubinemia of the well-baby nursery of the University Hospital of Patras, from     January 2008 to December 2010 will be reviewed.      The registry includes prospectively collected data such as sex, gestational age, gestation     and perinatal information, mother's and infant's ABO group and Rh, G6PD deficiency, Coombs     test, type of delivery and complications, birthweight, postnatal medications and     interventions, type and volume of feeding (daily), extension of jaundice, TcB measurements at     intervals of 12+/-4 hours until discharge, total serum bilirubin values (if obtained), TcB or     TSB measurements at follow-up, weight at discharge, need of phototherapy (inpatient or after     discharge). TcB and TSB values are plotted on a hour-specific chart.      A novel predictive nomogram based on TcB measurements (Varvarigou et al. Pediatrics     2009;124:1052-9) will be used to classify TcB values as high, intermediate, and low risk.      Significant hyperbilirubinemia will be defined as a TSB value above the phototherapy     threshold level according to the AAP 2004 guidelines      Statistics: Independent and joint effects of various clinical factors on the development of     significant hyperbilirubinemia will be evaluated by logistic regression analysis Cluster     analysis and Chi-squared Automatic Interaction Detection (CHAID) tree method will be used to     develop the strategy. At each step, CHAID chooses the independent (predictor) variable that     has the strongest interaction with the dependent variable. Categories of each predictor are     merged if they are not significantly different with respect to the dependent variable.   "
248590|NCT01109290|"     Hypohidrotic ectodermal dysplasia (HED) is a complex genetic disorder characterized by lack     of sweat glands, sparse hair, and missing or malformed teeth. Inability to sweat may result     in episodes of severe hyperthermia and cause sudden infant death. To assess sweat gland     function in HED patients, the investigators will first quantify gland pores in a defined area     of the palm and then stimulate the glands by pilocarpine followed by sweat collection in a     special capillary for volume determination. This will be combined with non-invasive skin     conductance measurement prior and subsequent to stimulation of the sympathetic nervous     system. The data should provide a basis for genotype-phenotype correlation.   "
248591|NCT01109303|"     Ankle fracture is frequent and its number is increasing. In Canada, surgical treatment of     these lesions is advised and the options currently used all have in common a rigid fixation     of the syndesmosis which results in residual stiffness and a high level of secondary surgery,     mostly to remove the implant.      The purpose of the study is to compare the treatment of ankle syndesmotic rupture by a     dynamic fixation to a static fixation suggesting that the dynamic fixation method will     improve the Olerud-Molander functional score of more than 15 points at the 3 months     follow-up.   "
248592|NCT01109316|"     This is a 6-sequence, 3-period (8 weeks each), 3-arm, 24-week crossover study. The purpose of     this study is to provide information on the use of insulin lispro in insulin pumps     (Continuous Subcutaneous Insulin Infusion [CSII]) compared to insulin aspart over 6 days of     pump reservoir in-use. The study will also compare the in-use characteristics of insulin     lispro infused at 6 days with insulin lispro infused at 2 days.   "
248593|NCT01109329|"     Human metapneumovirus (HMPV) is a virus that can cause respiratory illness. In older adults,     those with asthma, infants, and children, illness can be severe, but in healthy adults the     virus frequently causes no symptoms. The National Institute of Allergy and Infectious     Diseases (NIAID) is working to develop a vaccine for HMPV that could be given to infants.     Before potential vaccines can be tested, information about how HMPV affects healthy adults is     needed. This study will examine the effects of exposure to HMPV in healthy adults.   "
248594|NCT01109342|"     Two previous studies of an HIV preventive vaccine, the STEP study and the Phambili study,     were halted because people who received the vaccine were more likely to become infected with     HIV. Why this vaccine failed is still being researched, but one reason may be related to the     recombinant Adenovirus type 5 (rAd5) virus vector used in the vaccine. Two trials of another     HIV preventive vaccine that used a rAd5 virus vector were conducted in Uganda. This study     will obtain follow-up safety information on participants in those trials.   "
248595|NCT01109355|"     Intrathoracic positive pressure may lead to a change hemodynamics, with repercussions for the     intracranial compartment, thereby altering intracranial pressure (ICP) and cerebral perfusion     pressure (CPP). This effect may become more intense when using high positive end expiratory     pressure (PEEP) values. The aim of the present study was to measure the impact of different     PEEP values on ICP, CPP and mean arterial pressure (MAP). MAP, whereas high PEEP values     increase ICP, although without clinical relevance.   "
248777|NCT01112657|"     This is a prospective, multicentric, observational study with a 2 years recruitment period.     The purpose of the study is to observe the multiple sclerosis (MS) progression of subjects     since their first episode of neurological event and secondly, to determine status of     anti-AQP4 immunoglobulin (IgG) antibody in MS subjects.   "
248598|NCT01109394|"     Background:      - Laboratory investigators who are studying common childhood cancers are interested in     developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of     children who have cancer or adults who have common childhood cancers. To develop this     repository, additional samples will be collected from children and adults who have been     diagnosed with common childhood cancers such as leukemia and tumors of the central nervous     system.      Objectives:      - To collect and store blood, serum, tissue, urine, or tumor samples of children who have     cancer or adults who have common childhood cancers.      Eligibility:        -  Individuals who have been diagnosed with a common childhood cancer (e.g., leukemia)          regardless of patient age.        -  Children, adolescents, and adults who have been diagnosed with a type of cancer more          commonly found in adults.      Design:        -  Extra blood, serum (the liquid part of blood), tissue, urine, or tumor samples will be          collected from participants at a time when sampling is required for medical care or as          part of a research study.        -  No additional procedures will be performed for the sole purpose of obtaining additional          tumor tissue, aside from what is required for clinical care.   "
248599|NCT01109407|"     Background:      - Multiple myeloma is a type of cancer that affects white blood cells and has a poor     long-term survival rate. Two other types of cancer, monoclonal gammopathy of undetermined     significance (MGUS) and smoldering myeloma (SMM), may eventually progress and develop into     multiple myeloma. Researchers are interested in collecting samples from individuals who have     been diagnosed with MGUS and SMM to study possible risk factors for developing multiple     myeloma.      Objectives:      - To study risk factors that may cause MGUS and SMM to progress to multiple myeloma.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with either MGUS or SMM but do     not have multiple myeloma.      Design:        -  Participants will be examined by study researchers at the initial visit, at 6 months          following enrollment, and every 12 months for a maximum of 5 years.        -  The following tests may be performed: (1) blood and urine tests, (2) bone marrow          aspiration and biopsy, (3) imaging studies, and (4) a skeletal survey (a series of          skeletal X-rays of the skull, spine, pelvis, ribs, shoulders, upper arm, and thigh          bones).        -  Treatment will not be provided as part of this protocol. - Participants will remain on          the study for 5 years, or until their MGUS or SMM progresses to multiple myeloma          requiring treatment.   "
248600|NCT01109420|"     Background:      - Researchers are studying types of thyroid cancer that seem to cluster in families.     Non-medullary thyroid cancer accounts for the vast majority of all types of thyroid cancer,     but little is known about possible genes that may cause the cancer. More research is needed     to develop the best ways to screen for familial non-medullary thyroid cancer (FNMTC) so that     it can be diagnosed and treated at an early stage.      Objectives:        -  To evaluate the natural history of FNMTC.        -  To determine the best screening strategy for FNMTC.        -  To identify genes that may indicate susceptibility to FNMTC.      Eligibility:      - Individuals at least 7 years of age who have two first-degree relatives (e.g., parents,     children, siblings) who have or have had non-medullary thyroid cancer or a documented     diagnosis of non-medullary thyroid cancer and one living relative with documented     non-medullary thyroid cancer.      Design:        -  Participants will be evaluated by family history pedigree, physical examination, imaging          (including possible neck ultrasound and radioactive iodine scans), and laboratory          testing.        -  Participants who agree to have blood or other biological samples collected will be asked          to enroll in an additional study to provide the appropriate samples and tissues.        -  After the initial study evaluation, participants who are not found to have a malignant          thyroid tumor will be re-screened every year with non-invasive imaging studies.          Participants who are found to have a malignant thyroid tumor will be informed of          possible treatment options.   "
248601|NCT01109433|"     Background:      - Uveitis, the inflammation of the interior of the eye, is responsible for numerous new cases     of legal blindness every year. Uveitis can be caused by Beh(SqrRoot)(Beta)et s disease (BD),     a chronic inflammatory disorder that can affect the eye, mucous membranes, and other body     organs such as the joints, intestinal tract, blood vessels, and central nervous system.      Objectives:      The purpose of this study is to see how genes affect Beh(SqrRoot)(Beta)et s disease and if     there are differences in Beh(SqrRoot)(Beta)et s disease among people of different     backgrounds.      Eligibility:        -  Individuals who have a diagnosis of BD and are enrolled in another NIH study.        -  Individuals who are willing to donate blood for the purposes of this research study and          who are willing to have their blood stored for possible future/other research purposes.      Design:        -  As part of the study, blood samples will be drawn from participants when an exacerbation          in disease activity occurs and before and after any significant change in treatment for          BD.        -  No treatments will be provided in this study.   "
248778|NCT01112670|"     The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and     drug-drug interactions of sitagliptin therapy.   "
248603|NCT01109459|"     Current research shows low rates of quantitative vision screening at preschool ages in the     medical home. This study targets providers (PCPs) to evaluate the effectiveness of a     web-based intervention to improve knowledge about strabismus, amblyopia and preschool vision     screening, to increase preschool vision screening rates, and to improve rates of diagnosis of     strabismus and amblyopia by eye specialists.   "
248604|NCT01109472|"     Study aims to improve osteoporosis care through patient tailored education materials in a     group-randomized trial of patients referred to home health care with a history of fracture     and/or an osteoporosis diagnosis. Project investigators will conduct telephone surveys and     examine electronic medical record data to assess fracture related morbidity and mortality,     osteoporosis treatment and adherence, and use of calcium and vitamin D supplements.      We hypothesize that patients that receive the intervention materials will be more likely to     initiate or maintain osteoporosis treatment.   "
248605|NCT01109485|"     The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic     Solution 0.1% in Japanese children with allergic conjunctivitis.   "
248845|NCT01113541|"     The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of     metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with     glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their     current antipsychotic medication.   "
248606|NCT01109498|"     LPLD is a rare autosomal recessive disorder, characterized by the presence of marked     chylomicronemia and hence hypertriglyceridemia. Clinically the most severe manifestation of     chylomicronemia, is acute pancreatitis, which can be lethal. There is no effective therapy     available to modulate the course of the illness and prevent complications for these patients.     The current clinical management consists of severe reduction of dietary fat that is hard if     not almost impossible to comply with. LPLD subjects continue to experience pancreatitis     attacks, and are admitted to intensive care units on several occasions.      Alipogene tiparvovec corrects or restores lipoprotein lipase (LPL) function long term, and     hence reverses some symptoms, halts the disease progression and prevents further     complications. Alipogene tiparvovec gene therapy ensures that a catabolically beneficial     variant of the human LPL gene, LPL[S447X] is expressed and active in the relevant tissues in     humans. Delivery of the gene is realized via intramuscular injection of an adeno-associated     viral vector, pseudotyped with AAV1 capsids.   "
248607|NCT01109511|"     Objectives:      Primary objective:        -  To demonstrate that the treatment with OXN PR tablets up to 72 hrs after surgery is          superior to the treatment with OxyPR with regards to constipation in subjects with          postoperative pain after laparoscopic hysterectomy based on interviews 24h, 72 h and 1          week postoperatively.      The secondary objectives:        -  Analgesic effect (including registration during the first 24 hrs)        -  To asses the frequency of pain rescue mediation use (in the double-blind phase, 0-72          hrs)        -  Frequency of nausea and vomiting        -  Frequency of other adverse events        -  Appetite        -  Mobilization      The exploratory objectives:        -  Overall patient satisfaction at 24, 72 hrs and 1 week   "
248608|NCT01109524|"     The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used     for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and     Vinorelbine.   "
248609|NCT01109537|"     The purpose of the study is to understand the brain chemistry of people with Restless Legs     Syndrome (RLS). The primary hypothesis is that patients with RLS will have reduced GABA     levels in their Thalamus and elevated Glutamate levels in their Anterior Cingulate Cortex.     The study will use MRS imaging to examine the regional levels of these neurochemicals, GABA     and Glutamate, in the brain.   "
248610|NCT01109550|"     Biliary obstruction and cholangitis are common problems in gastroenterology and need specific     therapeutic interventions. Besides a variety of potential causes, infections of the biliary     tract with Candida and other fungal species have increasingly been reported in the last few     years. Especially interesting is the question, if patients with positive fungal cultures of     bile samples should be treated or not and under which circumstances. The primary aim of the     present study is to evaluate wether positive fungal cultures of bile samples indicate fungal     infection of the biliary tract, rather colonization or simply contamination during endoscopic     retrograde cholangiopancreatography (ERCP) procedure.   "
248611|NCT01109563|"     This study will test a behavioral intervention tailored for adolescents who smoke marijuana     and have concerns about their use. The study's purpose is to determine whether this     intervention (two-sessions of motivational enhancement intervention followed by 12 months of     optional skills training) will be more effective in reducing the use of this drug if     augmented by three periodic motivational enhancement treatment check-in sessions as compared     to three periodic computer-based check-in sessions.      HYPOTHESES: (1) Participants in the motivational enhancement treatment check-ins (MCI)     condition will reduce their use of marijuana more than participants in the computer based     (Comp) condition and report fewer negative consequences. These differences are expected to be     greater at later follow-ups (i.e, 9, 12, and 15 months) after repeated check-ins exert a     cumulative effect. (2)Engagement in CBT sessions will be greater for those in the MCI     condition and will partially mediate the effect on marijuana related outcome indices. (3) The     MCI intervention will lead to increased self-efficacy, and decreased normative perceptions of     marijuana use by other teens that will also partially mediate the effect of the intervention.   "
248612|NCT01109576|"     This is a pilot study of workshops to help Veterans with both vision and hearing loss live a     happier, fuller and less stressful life. The results will be used to guide the development of     a large scale clinical trial.   "
248628|NCT01109784|"     The use of dual antiplatelet therapy is considered standard of care in patients post     percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of     patients is considered clopidogrel resistant and this resistance is shown to be accompanied     by future adverse events. Additionally, clopidogrel resistance has been linked with the     CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients     undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as     estimated predischarge with the VerifyNow point of care system of platelet reactivity.     Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or     clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment     crossover will be performed. At day 60 platelet reactivity will be determined as well. In     addition, in all patients genetic determination of CYP polymorphisms (including the     CYP2C19)known to affect clopidogrel metabolism will be performed.   "
248629|NCT01109797|"     The purpose of the study is to compare two interventions for preparing diabetic teens and     young adults for transition from pediatric to adult diabetes care.   "
248630|NCT01109810|"     The IDEaL registry is a cooperative, observational registry focused on immunoglobulin use in     the U.S. The registry is a deliberate and purposeful assembly of clinical and humanistic     knowledge that is intended to act as a longitudinal database, tracking outcomes of routine     clinical practice.      The central goal of the registry is to provide a mechanism that allows for a better     understanding of how immunoglobulin therapy is being used in a real-world clinical setting.     The data gathered will help the industry gain a better understanding surrounding the     therapeutic value of immunoglobulin therapy and subsequently improve practices, reduce     medical costs, and ultimately improve the clinical outcomes for the patients receiving     immunoglobulin therapy   "
248846|NCT01113554|"     RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the     quality of life of breast cancer survivors.      PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving     quality of life in breast cancer survivors.   "
248613|NCT01109589|"     The main objective is to investigate the incidence of Respiratory Tract Infections (RTIs) and     antibiotic prescriptions in children and during pregnancy, the different drugs chosen by     their doctors according to diagnosis, and compliance by patients. Further to investigate the     possible effect of antibiotic use during pregnancy on RTIs and antibiotics and respiratory     drug prescriptions in children the first two years after birth.      Specific study objectives:        -  RTIs and antibiotic prescriptions in pre-school children             -  Frequency of diagnoses and antibiotic prescriptions             -  The proportion of broad spectrum antibiotics chosen        -  Prescription patterns and treatment compliance during pregnancy             -  Incidence of diagnoses, compared with not pregnant patients             -  Choice of antibiotics in RTIs             -  Prescription collection from pharmacies        -  Antibiotics and respiratory medication in children aged 0-2 yrs             -  Compare prevalence in children of mothers with frequent RTIs/antibiotic               prescriptions during pregnancy and prevalence in children of mothers with few or no               consultations during pregnancy             -  Incidence of wheezing and asthma diagnoses and incidence og respiratory               prescription drugs when the mother has received antibiotics in pregnancy   "
248614|NCT01109602|"     Approximately 780,000 people suffer a stroke annually in the United States; 200,000 are     recurrent strokes. The 17,000 veterans who suffer a stroke yearly are at great risk for a     second stroke and therefore should be targeted for stroke risk factor management and     prevention interventions.      Balance and fear of falling negatively impact activity and function. Decreased activity and     blood pressure (BP) are important modifiable stroke risk factors. These can be addressed     through a yoga exercise intervention. Yoga, like tai-chi, is old world alternative medicine     that has the potential to greatly impact the lives of older adults.   "
248615|NCT01109615|"     This study aims to investigate the efficacy and safety of the combination of pemetrexed and     gemcitabine in heavily pre-treated, chemotherapy resistant colorectal cancer patients with     KRAS mutations.   "
248616|NCT01109628|"     The present study is designed to investigate whether timed protein supplementation will     increase skeletal muscle mass in the frail elderly population.   "
248617|NCT01109641|"     The PING-EP study is designed to evaluate electrode properties on phrenic nerve stimulation     (PNS) in coronary sinus using a commercially available diagnostic electrophysiology catheter.   "
248618|NCT01109654|"     This is a multicentric, prospective, observational study on the use of Cetrotide to control     the endogenous gonadotrophin levels in Gonal-f stimulated ART treatment cycles in the     Asia-Pacific region. The study plans to enrol approximately 1800-2000 subjects over a 9-month     period at each participating centre.      This observational study is initiated to collect information on the use of Cetrotide (GnRH     antagonist) in ART cycles in routine practice across the Asia-Pacific region. The information     will allow a better understanding of the current ovarian stimulation regimens that involve     Cetrotide in the control of the endogenous gonadotrophin concentrations. The collection of     live birth data, though a challenging task, as a secondary endpoint will allow the study to     show valuable information on the final objective of ART. To minimize the potential     variability due to the different ovarian stimulation agents, the study is to include cycles     treated with Gonal-f (recombinant human FSH) since this agent is widely available in the     region.   "
248619|NCT01109667|"     The aim of this study is to assess the effect of Innovin® reagent on laboratory results when     compared with the Thromborel® S.   "
248620|NCT01109680|"     A Single Center, Open-Label Study to quantify metabolites of [14C]-Neramexane in plasma and     urine in Healthy Male Subjects   "
248621|NCT01109693|"     The purpose of the study is to establish the optimum treatment strategy for first-line and     second-line antidepressants in the acute phase treatment of major depression.   "
248622|NCT01109706|"     PCSK9 (Proprotein convertase subtilisin kexin type 9) plays a key role in LDL-cholesterol     (LDLC) metabolism by inhibiting LDL receptor (LDLR) at post-transcriptional level. PCSK9 loss     of function mutations are associated to decreased LDLC levels and a cardiovascular     protection. In this context, the development of pharmacological inhibitors of PCSK9, in     association with statins treatment, represents a major therapeutic issue for LDLC modulation.     It was previously shown that PCSK9 plasmatic concentration correlated with plasmatic LDLC, TG     and glucose concentrations. However, no data are available on predictive value of PCSK9     plasmatic level concerning coronary disease severity.      The main objective of this study is to determine whether plasmatic PCSK9 concentration is     linked to coronary damage severity in patients with acute coronary syndrome.   "
248623|NCT01109719|"     We will test whether the way that an intensive care unit is organized can influence patient     related outcomes such as mortality. We will test whether who works in the ICU, and how the     ICU is managed will affect the care received by patients. The primary study hypothesis is     whether the number of clinical protocols present in an intensive care unit is linked to     patient mortality   "
248624|NCT01109732|"     The purpose of this study is to investigate how systematic physical training after     endovascular treatment influence the durability of the endovascular treatment and how it     effects physical function, quality of life and future cardiovascular events.   "
248625|NCT01109745|"     The objective of this project is to establish the effectiveness of implementation of a     self-administered electronic asthma-specific quality of life instrument for childhood asthma     in primary care and specialist care.   "
248626|NCT01109758|"     The purpose of this study is to assess how fenofibrate modify gene expression in circulating     monocytes of healthy volunteers after 6 weeks.   "
248627|NCT01109771|"     To compare the use of absorbable tackers versus permanent tack fixation using a polyester     large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian)     prospective randomized single-blinded trial.      All patients referred for elective midline ventral hernia repair should be assessed for     eligibility and entered in a study log, detailing all included patients during the study     period.   "
248654|NCT01104376|"     The purpose of this study is to see if administration of medicines and genetic differences     affects the activity of a liver enzyme called CYP2B6 in healthy volunteers.   "
248803|NCT01112995|"     The purpose of this study is to investigate the feasibility, safety and efficacy of oral     probiotic, Lactobacillus rhamnosus versus oral placebo for reducing colonization by MRSA.   "
248631|NCT01109823|"     At the intensive care unit (ICU) fluoroquinolone antibiotics, like levofloxacin, are     frequently used for the treatment of infections.      Adequate blood levels are required for a good efficacy of the antibiotic. Due to the fact     that levofloxacin is almost completely eliminated renally, the blood levels for this     antibiotic are strongly influenced by the renal function. Therefore, this study aims to     evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison     with critically ill patients with normal renal function.   "
248632|NCT01109836|"     Aim of this randomized controlled study is to test if intensive polyintervention therapy     including life style modifications targeting at reduction of modifiable risk factors of     stroke can reduce the risk of post-stroke cognitive decline compared to a group of patients     receiving standard care.   "
248633|NCT01109849|"     Previous NIH funded Attention Deficit Hyperactivity Disorder (ADHD) trials in children found     that daily stimulant therapy produced sustained growth deficits. However, no federally funded     studies have examined the growth suppression associated with modern once a day stimulant     medications. Therefore, this study will precisely estimate the risks of stimulant induced     growth suppression (SIGS), examine the underlying mechanisms and develop treatments for it.     While drug holidays and caloric supplementation are two common treatments for SIGS, there has     been little systematic investigation of either. It is unknown if they are effective or     feasible. Therefore, using a randomized adaptive design, we will evaluate the efficacy and     feasibility of these two practices vs. routine monitoring of growth in 180 prepubertal     children with ADHD. An additional 50 subjects will be treated solely with behavioral     therapies to evaluate for growth abnormalities associated with ADHD. The study will assess     will the risk of SIGS with ER stimulants and the underlying mechanisms while providing     evidenced-based treatments for its management.   "
248634|NCT01109862|"     The purpose of this study is to compare hemiarthroplasty (HAP) with total hip arthroplasty     (THA), performed by trained arthroplasty surgeons with the use of large femoral heads for the     treatment of displaced femoral neck fractures in mobile independent elderly patients, to     determine the impact of these surgical options on the short term functional outcomes and     complication rates, namely dislocation and the need for further surgery.      This is a single-blinded prospective randomized clinical trial comparing functional outcome     and complication rates of 40 patients treated with all cemented THA to a control group of 40     patients treated with cemented bipolar HAP, in a 2 years followup.      The primary endpoint is the Oxford hip score (OHS) at last followup as a measure of     functional outcome. Secondary endpoints include the SF-36 score, walking distance and rates     of postoperative dislocation, component loosening, need for revision and postoperative     mortality.   "
248635|NCT01109875|"     The purpose of this study is to determine the incidence of Fabry Disease in young stroke     patients in an Israeli stroke clinic.   "
248636|NCT01109888|"     Coasting is one of the means to reduce the risk of OHSS for patients at risk for severe OHSS.     During coasting gonadotrophin administration is withheld until serum E2 levels drop to a     range considered safe. Prolonged coasting reduces the chance for implantation and pregnancy.     The aim of the study is to explore whether an increased dose of GnRH Antagonist will shorten     the coasting period without an adverse effect on cycle outcome.   "
248637|NCT01109901|"     The purpose of this study is to determine which surgical method is better for cubital tunnel     syndrome in outcomes.   "
248638|NCT01109914|"     The aim of this study is to verify whether vaccination with Dukoral® (SBL Vaccines) induces     an immune response in renal transplant recipients on prednisolone in combination with either     a calcineurin inhibitor CNI) or mycophenolate mofetil (MMF).   "
248639|NCT01109927|"     Among adult patients diagnosed with type 2 diabetes, about 6% have autoantibodies directed     against the insulin producing beta cells in the pancreas. These patients have a progressive     beta cell destruction and most of them will be insulin dependent within 3-5 yrs. Patients     with this latent autoimmune diabetes in adults (LADA) have a considerable remaining beta cell     mass at diagnosis, and are suitable for evaluating new therapies for autoimmune diabetes     Animal studies in diabetes prone mice have demonstrated potential positive effects of early     insulin treatment, with a lower incidence of diabetes or a delay before diagnosis. The aim of     this study was to investigate the effect of early insulin treatment of LADA patients, in     respect to residual beta-cell function and metabolic control, compared to a group who were     conventionally treated with diet and/or oral hypoglycaemic agents (OHA) and insulin not     before it was clinically needed.   "
248640|NCT01109940|"     This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in     patients with moderate to severe ankylosing spondylitis and aims to provide continuous     treatment with AIN457 for patients in the core trial, to obtain safety and tolerability     information. The study will address the evaluation of efficacy following doses of 3 mg/kg     AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the     risk/benefit balance of AIN457 in ankylosing spondylitis a decision was taken to continue     dosing for another 6 month period (Part 2).   "
248655|NCT01104389|"     A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical     System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors. To determine the     feasibility of the fluorescence imaging on the da Vinci Surgical System in robotic partial     nephrectomy procedures and report perioperative outcomes.   "
248804|NCT01113008|"     The aim of this study is to evaluate the phenomenon of remote ischemic post-conditioning in     humans. The minor myocardial damage associated with percutaneous revascularization procedures     may be attenuated by producing controlled ischemia in the arms immediately after carrying out     these procedures (remote ischemic post-conditioning). The justification and design of this     clinical trial has been reported: Cardiology. 2011;119(3):164-9.   "
248807|NCT01113047|"     This study will assess the efficacy and safety of the single pill combination of Aliskiren     and Amlodipine in patients with moderate hypertension not adequately responding to a single     pill combination of Olmesartan and Amlodipine.      Further this study will also assess the efficacy and safety of a single pill combination of     Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension     not adequately responding to a single pill combination of Aliskiren and Amlodipine.   "
249469|NCT01121536|"     The primary objective of this study is to evaluate the safety and tolerability of long term     (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in     adults with bipolar I disorder.   "
248641|NCT01109953|"     The patient has been referred for an FDG PET/CT scan. FDG is a form of sugar that contains a     small amount of radioactivity; it is used to see the size and possible spread of cancer in     the body.      Pictures of the body are taken on a machine called a PET/CT scanner. The purpose of this     current study is to see if we, the investigators, can take clearer pictures of the tumor than     we could with our routine scan method. This would allow us to better see how FDG is picked up     by the tumor. PET/CT is presently one of the best tools for detecting cancer and determining     its spread in the body. However, due to breathing motion, PET and CT images may become     blurred and the location of the tumor on CT and PET images may not match. We have developed a     new method that enables us to reduce image blurring and to measure the tumor more accurately     on PET images. In this study we want to compare two kinds of images: those from the standard     PET/CT scan, and the PET/CT scan pictures taken with our new method.      If successful, we may use this new method for clinical routine in the future.   "
248642|NCT01109966|"     The purpose of this study is to evaluate whether a new version of an amino acid based formula     improves tolerance to milk in cow's milk allergic infants/young children.   "
248643|NCT01109979|"     This study compares the effects of two common hormone medications on the heart and blood     vessels of healthy post-menopausal women over the age of 45.      The study will take place over the course of about 5 months. Each subject will take two     different medications over two six-week periods. They will be randomized at the beginning of     the study to either estradiol+medroxyprogesterone acetate or estradiol+drospirenone for the     first period, and will receive the other medication the second six-weeks of the study. At the     very beginning of the study and at the end of each six-week treatment period, subjects will     come to the hospital various tests including non-invasive blood vessel imaging tests, blood     draws to test the levels of certain hormones in the body, an oral glucose tolerance test, a     test to monitor renal blood flow, and 24-hour blood pressure monitoring. Between treatment     periods, there will be a four-week medication-free washout period.   "
248644|NCT01109992|"     This is a single-center study of subjects undergoing clinically indicated heart scans for     evaluation of known or suspected heart disease. We will also include 10 healthy subjects     without known heart disease. We would like to study stress testing of the heart using     exercise and a medication called regadenoson. Imaging of the heart will be performed.   "
248645|NCT01110005|"     The purpose of this study is to determine if intrapartum use of a glucose-containing solution     will improve the outcomes in pregnant women and their babies.   "
248646|NCT01110018|"     A single-centre, open-label, sequential, cross-over study to examine the safety, tolerability     and pharmacokinetics of 3 ascending single intravenous doses, a single 1000μg oral dose and a     single 1000μg inhaled dose of GSK573719 in healthy male volunteers.   "
248647|NCT01110031|"     Ofatumumab is a fully-human monoclonal antibody that exhibits high binding affinity to an     antigen on the surface of B lymphocytes. Antigen engagement by ofatumumab results in maximal     B-cell killing through complement-dependent cytotoxicity and antigen-dependent cellular     cytotoxicity in both antigen high- and low-expressing cells. Recent research has shown that     ofatumumab-dependent B-cell depletion provides clinical benefit to subjects with     CD20-positive cancers such as chronic lymphocytic leukemia (CLL). The purpose of the current     study is to assess the impact of ofatumumab on electrocardiographic parameters with     particular focus on cardiac repolarization (QTc interval duration) in subjects with     refractory CLL. Subjects enrolled in this open-label, single-arm trial will receive     ofatumumab at the highest clinical dose (2000 mg) studied or planned for study. Ofatumumab     will be administered as eight weekly intravenous (IV) infusions followed by four monthly     infusions, beginning in Week 13, across a 25-week treatment period. Cardiovascular effects     will be evaluated during treatment through routine 12-lead electrocardiographic (ECG)     monitoring. The pharmacokinetic relationship between plasma concentration of ofatumumab and     its effect on QTc interval duration will be examined. Specifically, ECG assessments will be     collected in triplicate at baseline, at the time of maximum ofatumumab concentrations     periodically on-therapy, and at the end of treatment. After completion of the final     ofatumumab infusion, subjects will continue to be followed for safety and efficacy for six     months relative to the last ofatumumab dose.   "
248648|NCT01110044|"     The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK     Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by     routine paediatric vaccination.   "
248649|NCT01110057|"     This study will be a double-blind, placebo-controlled, parallel group study. After enrolment     and initial assessments, subjects will receive 35 days of study medication. During this     treatment period, they will be randomised to either oral GW856553 7.5mg BID or matching     placebo in a 1:1 ratio. Sufficient numbers of subjects will be recruited to obtain 128     evaluable subjects.   "
248650|NCT01110070|"     The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in     the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6     months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System     may give symptomatic relief of pain and help to restore knee function. Included in this study     is pain relief using Visual Analog Scale (VAS), knee function using the International Knee     Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36     (SF-36) survey.   "
248651|NCT01110083|"     EMD Serono has closed enrollment into this trial prior to determination of maximum tolerated     dose (MTD). EMD Serono has decided not to pursue the development of EMD 1204831 in patients     with advanced solid tumors for reasons other than safety.   "
248652|NCT01110096|"     The study compares the effect on BMI of two different treatment options for obesity in     childhood. Families with at least one obese child and parent are invited to join the project.     The hypothesis is that family camp gives an additional reduction in BMI compared to a less     intensive family lifestyle school.   "
248653|NCT01104363|"     The purpose of this study is to evaluate the effectiveness of heavy Vinyl PolySiloxane (VPS)     and splinted implants impression (Study Group, SG) technique versus plaster implant     impression (Control Group, CG) technique, in 12 edentulous patients rehabilitated with the     All-on-4 concept and Procera® Implant Bridge (P.I.B.). A longitudinal, double blinded,     randomised clinical trial (RCT) was designed to evaluate the accuracy of the impression. All     patients were monitored from implant placement until prosthetic loading.   "
248656|NCT01104402|"     Individuals with CF develop chronic lung infections and suffer intermittent acute     exacerbations of their lung disease. Most exacerbations are not treated until they cause     increased symptoms, and patients seek medical attention. This proposal details a study of     home lung function and symptom monitoring. Subjects will be randomly assigned to one of two     groups: 1) home monitoring, in which spirometry and symptoms are recorded; or 2) standard     care. The home monitoring data will be transmitted electronically to the study center. If     spirometry or symptoms have deteriorated substantially, treatment for a CF pulmonary     exacerbation will be initiated. It is anticipated that use of home monitoring will lead to     earlier, more reliable recognition and treatment of exacerbations, which will translate into     better lung health.   "
248657|NCT01104415|"     The purpose of the study is to evaluate the safety and tolerability of multi-dose, open-label     LX606 in subjects with symptomatic carcinoid syndrome.   "
248658|NCT01104428|"     Due to high incidence of renal damage by Hench-schonlein Purpura(HSP) is the key to affect     prognosis, this project moves the research emphasis forward in line with the idea of     prevention of progress of disease, Which concerns on Traditional Chinese Medicine(TCM)     clinical research scheme evaluation of HSP, evaluates the renal damage and disease recurrence     as the end event, and comes to the evaluation through the comparative study that the vantage     point of the scheme of syndrome differentiation and treatment in detoxification, cooling     blood and removing blood stasis to the conventional treatments can reduce kidney damage and     recurrence rate.   "
248659|NCT01104441|"     Acetylsalicylic acid (Aspirin, ASA) is the most widely prescribed drug used in primary and     secondary prevention of cardiovascular disease. However, aspirin resistance has been     described, mostly in cardiac patients and is an independent predictive factor for a poor     survival. Two frequent conditions in patients with cardiovascular diseases, diabetes and     hypercholesterolemia, are also considered as risk factors for aspirin resistance. Among     patients with peripheral arterial disease, those with critical limb ischemia have the worst     cardiovascular prognosis. At one year, 23% are dead, 25% have a major cardiovascular event     and 25% have a major amputation (which can be combined). Aspirin resistance is poorly studied     in these patients, and to our knowledge no study has been made to assess the prognosis value     of aspirin resistance on cardiovascular outcomes in critical limb ischaemia patients.      Hospitalized critical limb ischaemia patients will be tested for aspirin resistance using the     bed-side point of care VerifyNow®, and will be followed during one year, including death,     fatal and non-fatal acute coronary syndromes, cardiac decompensation, stroke, and major     amputation.   "
248660|NCT01104454|"     The purpose of this study is to standardize methods in collecting and processing placenta,     umbilical cord and cord blood samples. Samples will be used to determine potential     differences between normal weight, overweight and obese individuals.   "
248661|NCT01104467|"     The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given     to Japanese patients with acute ischemic stroke   "
248662|NCT01104480|"     This is a study for one patient with severe relapsing polychondritis which has been     unresponsive to other more conventional medications including prednisone, methotrexate,     anakinra and TNF inhibitors. Tolerability, and efficacy of the drug, Tocilizumab will be     monitored by clinical assessment and bloodwork.   "
248663|NCT01104493|"     To assess the safety of a new influenza virus vaccine containing a new virus strain in     healthy patients prior to the release of the vaccine.   "
248664|NCT01104506|"     In the context of an insufficiency of clinical results for cortical stimulation in treatment     of brachial plexus post-avulsion pains, one of the possibility for failure is the bad     pre-surgery mapping of the area to stimulated bu the usual methods (PEM et fMRI). This     purpose of this study is to realise a precise mapping of the primary motor cortex post     brachial plexus avulsion.      The principal endpoints is to identify and test the reliability of a muscular marker for     which the cortical representation is localized immediately next to the superior member area.     Several muscles of cephalic, cervical and chest area will be investigate.      The methods used will be mono-shock transcranial magnetic stimulation (mTMS) and functional     MRI.      Concerning mTMS, several methods will be tested: best position on the scalp, realisation of     outputs maps with extreme points average method, with mass center method.      Concerning fMRI studies, the above paradigms will be checked: imaginary movements of hand,     blow up and down abdomen, eyes winking.      Statistical tests will confirm the best muscle candidate and will permit to evaluate the     reliability of the method.   "
248665|NCT01104519|"     A study to evaluate the inter- and intra subject variabilities of flow-mediated dilation     (FMD) of brachial artery and nitroglycerin (GTN) induced dilation of brachial artery.   "
248666|NCT01104532|"     The purpose of the study is to evaluate pharmacokinetics, pharmacodynamics and safety     following the administration of ASP1941 and sitagliptin in single and multiple doses.   "
248667|NCT01104545|"     This study will determine if MK3614, given as single doses, is safe and well tolerated in     healthy males and male subjects with mild to moderate hypertension.   "
248668|NCT01104558|"     At present, there is some clinical data for different functional response to beta-blockers     associated with beta-adrenergic receptor polymorphisms. But there has been no data reported,     about the incidence of beta-adrenergic receptor polymorphism and association with     beta-adrenergic receptor polymorphism and response to beta-blocker therapy in Korean heart     failure (HF) subjects. This single-arm, open-label, multicentric study is designed with the     purpose of analyzing the association between genetic polymorphism of beta-adrenergic receptor     and the effects of beta-blocker (bisoprolol) in Korean HF subjects.   "
248678|NCT01110174|"     A pilot study of adult (≥ 18 years) women with stage II-III breast cancer who will receive     preoperative chemotherapy prior to mastectomy. Patients will have real-time serum glycan     profiling, expression of tissue MUC 1 oncoprotein isoforms to predict neoadjuvant     chemotherapy response and additional mammography and HD PET/CT examinations to assess     response. The investigators hypothesize that a functional tumor assessment utilizing     high-definition positron emission tomography/computed tomography (HD PET/CT), real-time serum     glycan profiling, and expression of tissue MUC 1 oncoprotein isoforms will predict     neoadjuvant chemotherapy response in breast cancer patients.   "
252872|NCT01166243|"     The objective of this study is to evaluate the safety and and hemostatic effectiveness of the     Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding     during hepatic surgery.   "
248669|NCT01104571|"     RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Lapatinib ditosylate may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet     known whether trastuzumab or lapatinib ditosylate is more effective in treating women with     early breast cancer.      Update June 2013:      Since the initial development of EPHOS-B in 2007 more evidence in relation to safety and     efficacy of anti-HER2 therapies are now available, and in particular, a growing body of     evidence that combinations of two anti-HER2 therapies are more effective than monotherapies.     Therefore this study has been amended (PART 2) to a 1:1:2 ratio to control, perioperative     trastuzumab or the combination of lapatinib and trastuzumab.      PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works     compared with lapatinib ditosylate (and in since June 2013 - Part 2 - compared with a     combination of lapatinib and trastuzumab) in treating women with early breast cancer.   "
248670|NCT01104584|"     The purpose of this study is to look at the efficacy (how does it work) and safety of     gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of     breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the     breasts as MRI may detect additional breast cancers   "
248671|NCT01104597|"     Previous research has shown that Asian Indians are at relatively high risk for developing     diabetes, heart problems and high blood pressure.      The purpose of this study is to evaluate subclinical atherosclerosis (an early sign of heart     disease) which may be associated with abnormalities like diabetes mellitus, hypertension     (high blood pressure), high cholesterol and heart problems.      Endothelium is the inner lining of your blood vessels. Endothelial dysfunction is found more     in people with diabetes. In addition, high body mass index (BMI) is a strong risk factor for     developing metabolic abnormalities like diabetes mellitus. This research study may provide     information as to how useful endothelial dysfunction will be to detect people at risk of     metabolic abnormalities and heart disease at an early stage.      Two groups of subjects will be enrolled. Caucasians and Asian Indians There will be a total     of 100 subjects participating in this study. Approximately 50 Caucasians and 50 Asian Indians     will be enrolled. Caucasians will serve as the control group for this study.   "
248672|NCT01104610|"     The purpose of this study is to investigate the evolution of daytime partial pressure of     carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support     ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP)     alone versus NIV-PSV.   "
248673|NCT01110109|"     In this study, subjects meeting criteria will be enrolled and randomized to one of two     different suctioning schemes, either continuous or intermittent. Accumulated secretions will     be collected above the cuff on the breathing tube by one of the two methods depending on     which group the subject is randomized into. Secretions will continue to be collected at     predetermined periods of time for the duration of surgery in order to characterize the pH and     volume as well as the micro-organism content.   "
248674|NCT01110122|"     Rationale: During exercise protein breakdown in muscles is larger than protein synthesis.     This negative muscle protein balance leads to increased muscle damage and thereby to a     reduced muscle tissue recovery. To achieve a positive muscle protein balance and reduce     muscle damage, many athletes use proteins. In professional soccer players, considerable     stress is placed on the musculoskeletal system. Recovery time is often too short for these     players to restore homeostasis, which results in catabolic processes. This increases playing     errors and will lead to lapses in concentration. Therefore, it is of great importance for a     professional soccer team to be in optimal condition and a fast recovery after exercise is     desirable to accomplish maximum performance. Supplementation with whey proteins is thought to     support this.      Objective: To assess whether post-exercise supplementation with whey protein will lead to a     better muscle recovery than supplementation with carbohydrates in Dutch soccer players     between the age of 15 and 18 years old.      Study design: A double blind randomised controlled cross-over trial.      Study population: Healthy soccer players of the A and B selection of AJAX between the age of     15 and 18 years old.      Intervention: Supplement, containing either whey proteins or an isocaloric carbohydrate     placebo. Each supplement will be administered for 2 weeks separated by a 7 day washout     period. Treatment order will be randomly assigned.      Main study parameters: The main study parameter will be the Yo-Yo intermittent recovery test     level 2 score and the vertical jump test. The scores will evaluate the soccer players'     ability to repeatedly perform intense exercise and his potential to recover from this     exercise.   "
248675|NCT01110135|"     This phase II trial is studying how well giving bendamustine hydrochloride, etoposide,     dexamethasone, and filgrastim together for peripheral stem cell mobilization works in     treating patients with refractory or recurrent lymphoma or multiple myeloma. Giving     chemotherapy, such as bendamustine hydrochloride, etoposide, and dexamethasone, before a     peripheral stem cell transplant stops the growth of cancer cells by stopping them from     dividing or killing them. Giving colony-stimulating factors, such as filgrastim, and certain     chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be     collected and stored   "
248676|NCT01110148|"     The investigators investigated the use of portable MP3 technology in patient education and     informed consent of shave and punch biopsies. Eighty patients were divided randomly into a     control and experimental group. Control patients received the standard of care in patient     education and informed consent. Experimental patients watched a short 80-second video on     shave or punch biopsies. All patients were given pre- and post-education questionnaires to     assess the efficacy of each method.   "
248677|NCT01110161|"     The goal of this project is to compare visceral fat measurements derived from Lunar iDXA     total body scans and from Computed Tomography (CT) scans of the abdominal region for a     Chinese population.   "
248679|NCT01110187|"     Trial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental     status changes due to severe traumatic brain injury (sTBI) will result in improved short- and     long-term outcomes and better immediate adverse effects when compared to the current standard     of care anticonvulsant (IV fPHT) and will be at least as effective as IV fPHT in preventing     clinical and sub-clinical seizure activity.   "
248680|NCT01110200|"     This trial is a randomized, double-blind, parallel-group, multicenter study to be conducted     in the United States. The purpose of the study is to evaluate the rate of exacerbations of     chronic obstructive pulmonary disease (COPD) following hospital discharge for an acute     exacerbation of COPD, in patients receiving either fluticasone propionate/salmeterol     combination product 250/50mcg BID or salmeterol 50mcg BID via DISKUS™ over 29 weeks. The     study population will include patients hospitalized for an acute exacerbation of COPD. The     target enrolment is 720 subjects at 80 study centers. The primary endpoint is the rate of     exacerbation requiring hospitalization that occur more than 21 days post-discharge, emergency     room visit or physician's office visit for an exacerbation of COPD requiring treatment with     oral corticosteroids or oral corticosteroids and antibiotics. The secondary endpoint is the     rate of COPD exacerbation requiring treatment with oral corticosteroids, antibiotics, and/or     hospitalization (alone and in combination). Related efficacy endpoints include, time to first     exacerbation of COPD requiring treatment with oral corticosteroids, antibiotics, and/or     hospitalization (alone and in combination), pre-dose AM FEV1, the probability of premature     withdrawal of subject from the study, and supplemental albuterol use, change in biomarkers of     inflammation, including, surfactant protein D (SP-D), clara cell secretory protein 16 (CC-16)     and high sensitivity C-reactive protein (hs-CRP). Health outcome assessments include domain     scores evaluation for fatigue, dyspnea, emotional function and mastery, measured with the     Chronic Respiratory Disease Questionnaire self-administered standardized format (CRQ-SAS);     and symptoms (congestion, cough, phlegm, mucus, chest discomfort, shortness of breath and     sleep disturbance), assessed by the EXAcerbations of Chronic pulmonary disease Tool (EXACT).     Albuterol will be supplied to study subjects for use as-needed throughout the study. Safety     will be assessed by monitoring of adverse events.   "
248681|NCT01110213|"     The primary aim of this feasibility study is to determine if a theory-based lifestyle     intervention consisting of telephone counseling is associated with improvements in physical     activity and dietary intake.   "
248682|NCT01110226|"     This is a Phase I Clinical Trial. Phase I studies are designed to determine the amount of     investigational drugs that can be safely delivered and to define the side effects that limit     the dose. The drug administered in this study is KML-001. It is a highly soluble, orally     available arsenic agent. It is currently being tested to determine its effects on telomerase     activity.      In other words, the purpose of this research study is to find the highest dose of KML001,     that can be given without causing severe side effects when it is combined with a standard,     commercially available anti-cancer drug called cisplatin.   "
248683|NCT01110239|"     In remote preconditioning, ischemia in one organ protects distant organs from ischemic     insults. e.g. brief induced limb ischemia protects the brain from an otherwise more severe     stroke.      The objective of this study is to determine if remote ischemic preconditioning can be safely     and effectively instituted in patients with subarachnoid hemorrhage, who are at high risk for     developing disabling cerebral ischemia. The investigators will also preliminarily assess if     there is evidence for neuroprotection. This will be a Phase 1b study.      Additional objectives are:        1. to determine if remote ischemic preconditioning can be safely and effectively instituted          in patients with subarachnoid hemorrhage, who are at high risk for developing disabling          cerebral ischemia.        2. analogously to a dose-escalation study the investigators propose to study the safety and          tolerability of increasing durations of limb ischemia until a target time of 10 minutes          of limb ischemia has been reached.   "
248684|NCT01110252|"     The purpose of this study is to determine whether the cell therapy with bone marrow     mononuclear cells is safe in the treatment of chronic obstructive pulmonary disease,     specifically the pulmonary emphysema.   "
248685|NCT01110265|"     Research has consistently found attentional biases towards negative weight-related stimuli in     individuals with eating disorders. It has been suggested that these biases may act as a     vulnerability factor for the development and maintenance of body dissatisfaction and may     therefore be an important target for intervention. Previous studies have demonstrated the     capacity to modify the patterns of attention allocation to threatening stimuli in a variety     of anxiety disorders, with a subsequent and sustained reduction in anxiety symptoms. Thus,     the present study aimed at testing the efficacy of attention training in reducing attentional     biases and eating disorder symptoms in individuals with elevated levels of body image     disturbance and eating disorder symptomatology of clinical severity. Thirty-two participants     were randomly allocated to receive eight sessions of a 10-minute computer task aimed at     training their attention away from weight-related stimuli or a control placebo training     condition. Results showed that participants in the attention training group had a     significantly greater reduction in their attentional bias and body dissatisfaction from pre-     to post-training relative to the placebo condition. At follow-up, both groups showed a     significant decrease in body dissatisfaction from their pre-training levels. The only     significant difference between groups in eating disorder symptoms at follow-up was in terms     of the attention training group experiencing a greater reduction in weight and shape     concerns.   "
248686|NCT01110278|"     Urgency incontinence (where the bladder muscles contract suddenly, causing an immediate urge     to urinate that is difficult to prevent) is commonly experienced in patients with overactive     bladder. New findings have discovered that urgency incontinence may be connected to the     interactions of certain regions of the brain and the bladder. Although this is a common     problem, researchers still do not know how these interactions impact the process of urgency     incontinence. The purpose of this study is to better understand how the brain functions, by     using Magnetic Resonance Imaging (MRI) machine and Diffusion Tensor Imaging (DTI) to create     images of the brain during different bladder states.   "
248687|NCT01110291|"     Twenty patients with verified high risk breast cancer will be included in the study. Patients     will receive three cycles of docetaxel followed by three cycles of CEF for their adjuvant     treatment. The phenotype of CYP3A and the genotype of CYP3A5 and MDR1 will be assessed. Also     the effect of docetaxel in the activity of CYP3A will be measured by peroral midazolam.      Primary Object:      The primary object of this study is to define, if it is possible to predict the clearance     and/ or toxicity of docetaxel by assessing        -  activity of CYP3A4 by midazolam test (CYP3A4 phenotype)        -  CYP3A5 genotype        -  MDR1 genotype      Secondary object:      The secondary object of this study is to define whether the treatment with docetaxel alters     the activity of CYP3A4 enzyme in previously untreated breast cancer patients.   "
248688|NCT01110304|"     Acromio-clavicular (AC) joint dislocation corresponds to 8.6% of all joint dislocations and     represents a major injury to the shoulder girdle. The nature of the treatment is decided     according to the severity of the lesion.      The purpose of this study is to determine whether the surgical treatment is required or not     for type III AC joint dislocations.   "
248689|NCT01110317|"     The purpose of this study is to evaluate the concentration of paliperidone in the blood after     intramuscular injection in upper arm (deltoid muscle) or in the buttock (gluteal muscle) in     patients with schizophrenia.   "
248691|NCT01110343|"     This application compares the effectiveness of a conventional Parent Group intervention to     Mindfulness- Based Stress Reduction (MBSR) in parents of children with autism spectrum     disorders (ASD) and other disabilities. Parent groups are widely-used to provide information,     emotional support, education and advocacy. MBSR is efficacious for people with medical,     psychiatric or other concerns, and teaches stress reduction through mindfulness training and     practice. In contrast to conventional parent groups, the investigators' studies suggest that     mindfulness-based interventions may be particularly effective in reducing stress and     improving the health and mental health of parents of children with disabilities. The     investigators will assess parent factors that may correlate with intervention efficacy in the     2 treatment arms.   "
248692|NCT01110356|"     research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be     due to iron deficiency.   "
248693|NCT01110369|"     The present study is designed to investigate whether timed protein supplementation will     increase skeletal muscle mass in the frail elderly population.   "
248694|NCT01110382|"     The purpose of the study is to evaluate the safety and tolerability of doripenem compared     with meropenem in children hospitalized with complicated intra-abdominal infections.   "
248695|NCT01110395|"     Heart needs constant supply of energy to continue working. Phosphorus magnetic resonance     spectroscopy allows us to measure energy produced in the heart. The purpose of this study is     to determine if the energy production is reduced in failing heart.   "
248696|NCT01110408|"     The purpose of this study is to evaluate the safety and tolerability of doripenem compared to     cefepime in children hospitalized with complicated urinary tract infections.   "
248697|NCT01110421|"     The purpose of this study is to evaluate the safety and tolerability of doripenem compared to     cefepime in children hospitalized with pneumonia.   "
248698|NCT01110434|"     Cannabis use is a significant public health concern that disproportionately affect youth.     Although promising psychosocial interventions are being developed, most youth do not benefit     from these interventions alone. Given the clinical demand for effective treatments, the     National Institute on Drug Abuse (NIDA) identified the critical need for data on the     tolerability and potential efficacy of medications in adolescents. The purpose of this     two-year study is to test if and how topiramate, a medication under intense study for     treating several drugs of abuse, reduces cannabis use among teenagers. To this end, the     investigators will randomize 56 nontreatment-seeking regular cannabis users (15 or 20 years     old) to receive topiramate or placebo for 6 weeks. Youth will monitor their cannabis use for     the 6-week period using handheld electronic diaries and complete assessments of reactivity to     cannabis-related cues.   "
248699|NCT01111630|"     The purpose of this study is to compare the hemoglobin and hematocrit variability between     once and three times weekly erythropoietin therapy for the anemia in patients with     maintenance dialysis.   "
248700|NCT01111643|"     To assess the utility of technician-based analysis of echocardiograms with longitudinal     strain for ruling-in ischemic chest pain in the emergency room, compared to emergency room     (ER) physician opinion and expert echocardiographer analysis of wall motion, both the latter     blinded to any relevant clinical data .   "
248701|NCT01111656|"     The SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study     is the follow up study of the SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple     Sclerosis (SWABIMS) (see http://www.clinicaltrials.gov. Identifier: NCT00942591) SWABIMS     evaluated the efficacy, safety and tolerability of atorvastatin 40 mg in addition to     interferon-beta 1b compared to interferon-beta 1b monotherapy in patients with     relapsing-remitting multiple sclerosis for 15 month. The SWABIMS Follow up study observes     patients that finish the SWABIMS study for another 12 month with ongoing unchanged     medication.   "
248702|NCT01111669|"     Functional endoscopic sinus surgery (FESS) is an effective treatment of sinus disease. FESS     is carried out using cameras to view the surgical field. Bleeding during the surgery can lead     to poor surgical field visualization. Poor visualization has been associated with worse     surgical outcomes. Tranexamic acid is a safe and effective agent used to achieve hemostasis     during operative procedures. The current study is a randomized controlled trial in patients     undergoing FESS to compare the effects of tranexamic acid versus placebo and the effects on     surgical field visualization and adverse events.   "
248703|NCT01111682|"     This study examines the role of osmotic agents in controlling brain swelling in brain injured     individuals. Two osmotic agents -- mannitol and hypertonic saline -- are in common use, and     they will be compared in the context of a randomized clinical trial. The goal is to determine     if these agent differ in their ability to control episodes of brain swelling.   "
248704|NCT01111695|"     In this open study, the primary objective is to study the efficacy and clinical outcome of     the chronic wounds treated with this preparation for 8 weeks on 30 adults. Evaluation will be     based on standardised photographs and clinical data.      The secondary objectives are to evaluate the tolerance and side effects of the honey based     preparation in the management of chronic wounds.   "
248705|NCT01111708|"     The purpose of this study is to investigate a new technique: Close Rectal Dissection (CRD) as     restorative surgery for Ulcerative Colitis patients: the Close Rectal Ileo Pouch Anal     Anastomosis (CR-IPAA). Clinical outcome and quality of life will be compared to the     conventional Ileo Pouch Anal Anastomosis (C-IPAA) and the Ileo Neo Rectal Anastomosis (INRA).   "
248706|NCT01111721|"     Project POWER will test the efficacy of a multi-session HIV Prevention program, adapted from     an existing program (Project SAFE), for incarcerated women in the rural South.   "
248761|NCT01112436|"     This prospective randomized study aims to evaluate the effectiveness of periarticular     multi-drug regimen injection on the relief of pain in patients undergoing partial hip     replacement.      Total 258 patients will be randomized into one of two groups (groupC or groupI) based on     Excel number generation.      Patients in group C will receive no medication intraoperatively, and patients in group I will     receive oral oxycodone and celecoxib preoperatively and a periarticular injection of     multi-drug regimen during operation.      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 1, 4, 7     postoperative day.   "
248707|NCT01111734|"     Deliberate Self-Harm (DSH) among adolescents is a serious behavioral problem associated with     significant injury, impaired functioning, reduced quality of life, and high rates of     psychiatric hospitalizations. While DSH has not been shown to have a direct link to suicide     attempts themselves, there is a clear link between individuals who engage in DSH and overall     rates of suicide. There is currently no medication treatment approved by the FDA for the     treatment of DSH.      The goal of this study is to evaluate the efficacy and safety of the dietary supplement     N-Acetylcysteine in adolescents aged 13-21 with deliberate self-harm behaviors. There will be     an additional neuroimaging component to expand knowledge regarding the neural correlates of     this treatment in the study population. We hypothesize that N-Acetylcysteine will reduce the     severity of deliberate self harm behaviors because this supplement has been helpful in     treating disorders that share some similar traits with DSH. We will be using this medication     in 40 young people who deliberately harm themselves and we will assess the severity of their     behaviors while being treated with this dietary supplement. We also will collect neuroimaging     data on the study participants at baseline and after the treatment with N-Acetylcysteine and     compare it to 40 age-matched healthy peer neuroimaging data. The purpose of including this     healthy group is to expand knowledge about neural correlates of the study population prior to     treatment.   "
248708|NCT01111747|"     The central third of the patellar tendon is used as a donor site for anterior cruciate     ligament (ACL) reconstruction. After months or years the harvest site partially regenerates.     The regeneration process is accomplished by biological mechanisms,including cells and     proteins known as growth factors. The platelets are natural reservoirs of growth factors, and     a platelet concentrate known as Platelet-Rich Plasma (PRP) has a three to five fold increase     in growth factors. The hypothesis of the study is that the PRP can improve the regeneration     of the patellar tendon.      The platelets are obtained from the patient's blood through a filtration system called     apheresis, with the use of 250 milliliters of blood, with a sterile system. All the others     components of blood (red cells, plasma, white cells) returns to the patient. The PRP is then     applied in the harvest site on the patellar tendon, at the end of ACL reconstruction.      The patients are randomized in two groups, one with the use of PRP and the other group     without PRP. This information for the patients will be granted just at the end of the     research. After the surgery the rehabilitation protocol is the same for both groups. An     isokinetic testing is done before the surgery and after six months. Questionnaires about the     knee function are asked before the surgery and after six months. A magnetic resonance imaging     is performed after six months to evaluate the tendon regeneration.   "
248709|NCT01111760|"     The purpose of this study is to compare the radiation exposure of a variety of chest CT     examinations performed on the current state of the art CT scanners (64 slice, dual source CT     scanner) with the radiation exposure for identical chest CT examinations performed on the     Siemens Flash CT scanner (high pitch dual source spiral technique).   "
248710|NCT01111773|"     The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg     and tetracaine 70 mg topical patch for the treatment of pain associated with patellar     tendinopathy.   "
248711|NCT01111786|"     Thirty subjects with systemic sclerosis and 30 age and sex matched controls without any known     condition that should cause increased skin hardness in the fingers with undergo examination     by manual palpation and durometer measured hardness of their digital tuft skin by 2 observers     on 2 separate occasions. There will be 1 hour between individual observer's scorings.     Observers will be blinded from the observer's scores and from their previous scores. Results     will be tabulated and compared for manual scores versus durometer measurements,     intra-observer scores by both methods and inter-observer scores by both methods.   "
248712|NCT01111799|"     It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of     the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the     rates of implantation and pregnancy. The hypothesis of our present study is that the     endometrial injury procedure will have the same beneficial effect in patients undergoing     controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).   "
248713|NCT01111812|"     The 'Meir children's sport and health center' runs a multi-disciplinary intervention program     for the treatment of overweight and obese children and adolescents. The program includes     physical activity, dietary guidelines, medical supervision and behavioral treatment. The     participants are routinely weighed once a week, at the same day and time, in order to     supervise their progress. According to our experience, the child can predict his weight     change, based on his behavior in the previous week. To our knowledge the overweight/obese     child's ability to predict his weekly weight change, while participating in a     multi-disciplinary intervention program, has never been tested.   "
248714|NCT01111825|"     The purpose of this study is to test the safety and benefit of two new drugs for the     treatment of breast cancer. The patient is eligible for the study because their breast cancer     has grown in spite of standard treatment. The two drugs tested in the study, Neratinib and     Temsirolimus, will be given together. Also, this study will help the investigators learn why     therapy directed against HER2 sometimes stops working.   "
248715|NCT01111838|"     The purpose of this study is to find out what effects, good and/or bad STA-9090 has on     colorectal cancer. This is a phase II trial which tests both how well the drug works in     fighting your cancer as well as any possible side effects it will have on the patient.      Cancer is a disease of uncontrolled growth. This growth is controlled in part by a series of     proteins that are part of a growth pathway. Some of these proteins are destroyed by a protein     called HSP90 and STA-9090 is a test drug which blocks one of the proteins that helps cancer     grow. This study will also look at molecular markers that may affect how the cancer grows,     and how it responds to treatment.   "
248716|NCT01111851|"     This study will evaluate if the mean value of brain neurokinin 1 (NK1)-receptor occupancy of     participants treated with aprepitant is similar to that of participants treated with     fosaprepitant at certain timepoints.   "
248762|NCT01112449|"     Penn State Milton S. Hershey Medical Center researchers are trying to compare the effects of     two different forms of selenium (selenium yeast and selenomethionine) on blood selenium     levels and biomarkers of oxidative stress as primary endpoints. One in six men are at risk of     getting prostate cancer in their lifetime. Participants will be asked to take     over-the-counter selenium yeast supplements and selenomethionine or a placebo for nine out of     twelve months.   "
248717|NCT01111864|"     Infants and children under two years are the group with the highest rates of iron deficiency     anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home     iron fortification of complementary foods using micronutrient powders can be an effective     approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient     powders that contain the entire iron RDA for a child in a single dose in areas with high     rates of infections from malaria and diarrheal disease. Therefore, in this study, we will     investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of     highly bioavailable iron, provided by a micronutrient powder added to a complementary food.      The study aim is to determine if in-home fortification using an iron-containing micronutrient     powder in Kenyan infants will improve iron status and/or modify the composition and metabolic     activity of the gut microbiota. Active surveillance will be done weekly to monitor the health     of the infants.      Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding     trial in which 330 infants will be randomized to receive a micronutrient powder containing     either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only     over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and     after 6 months will be used to define the iron status and the anemia level of the infants.     Stool samples (2 at baseline before intervention, 6 throughout the study and additional     samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the     entire study (n=330), we will measure changes in iron status over 1 year.   "
248718|NCT01111877|"     This study was conducted to describe the time to first incidence of otorrhea post     tympanostomy tube insertion.   "
248719|NCT01111890|"     Subjects are dosed twice daily at 9AM and 9PM for 12 weeks. The primary efficacy variable is     the mean change in Intraocular Pressure (IOP) from baseline to 12 weeks. Secondary efficacy     variable: % IOP ≤ 18 millimeters mercury (mmHg). Exploratory endpoint: Ocular discomfort     scale after first dose.   "
248720|NCT01111903|"     Study in two stages, and with a sub-study.   "
248721|NCT01111916|"     The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue     elasticity parameters in the female pelvis.   "
248722|NCT01111929|"     Prolonged breast-feeding is an encouraged tradition in Egypt. Breastfeeding is associated     with variable degrees of amenorrhea and infertility but there is a risk of resumption of     fertility and therefore, of conception during lactation. A consensus statement formalized the     lactational amenorrhea method of contraception (LAM), which has subsequently been included in     the family planning programs in some developing countries. It has proved to be effective with     cumulative pregnancy rates ranging from only 0.9% to 1.2%. However, if any of the     prerequisites of LAM expire at any time, the contraceptive efficacy will be much reduced.      The expiry of LAM requirements can occur unexpectedly at a time the woman is not ready to     visit a clinic to initiate another contraceptive. Pregnancy during breast-feeding may result     in mistimed, unplanned and sometimes unwanted childbirth. A study done in Egypt has shown     that one in 4 of pregnancies during lactation were unplanned Such pregnancies, in addition to     their negative social impact may lead some women to seek induced abortion; a procedure which,     in settings (like Egypt) where abortion is illegal (except on very restricted grounds), is     often unsafe.      Levonorgestrel 1.5 mg EC pills has been used for long time and proved to decrease the     incidence of pregnancy by 75-85% in each act of unprotected sexual intercourse. Its safety     has been documented. It can be used safely during lactation and has been classified by the     WHO medical eligibility criteria for contraception as category-1 for lactating mother. Even     if take early in pregnancy it is not abortifacient and does not by any mean affect the     continuation of pregnancy or cause any side effects to the growing baby (WHO category 1).      The present study tries to estimate the efficacy of in advance provision of 1.5     Levonorgestrel EC pills (as a back-up of LAM) at the time of counseling of LAM when used in     increasing the incidence of initiation of another long term method of contraception and     probably decreasing the incidence of unintended pregnancy during breast-feeding in rural     Egypt.      The investigators are planning to include all women who deliver in the investigators service     and intent to breast-feed and planning of birth spacing. Women who refused to participate or     planned to use a method of contraception other than LAM and those with expected difficulty of     subsequent communication were excluded from participation.      All eligible participants will receive proper counseling for LAM by trained research nurse.      Women who choose to use LAM will be advised to return to the investigators contraception     outpatient clinic to have a long term method of contraception as soon as any of the     requirements of LAM expires. All eligible participants who accept to participate in the study     will be randomly assigned to one of two groups:Group 1 will only receive the above described     care (control group). Group II (Intervention group) in which women will have the above proper     counseling. Additionally, they will be advised to use the EC pills if one of the     prerequisites of LAM expires and sexual relation with their husband had occurred before the     initiation of another contraceptive. Each women assigned to the intervention group will be     supplied with one packet containing two 0.75 mg Levonorgestrel emergency contraceptive (EC)     pills and advised to swallow the two tablets as soon as possible after having sexual     intercourse with their husband after the expiry of LAM. They will be informed that they     should not use the method after more than 5 days of having intercourse. They will be also     advised not to use EC pills more than once. All women who have used the EC pills need to     visit the clinic within few days of use for contraception advise. All the above information     will be additionally given to the patient in a small flyer.   "
248723|NCT01111942|"     This is a non-randomized open-label investigator initiated pilot study comparing follow-up     therapy of advanced head and neck cancer subjects initially treated with triple induction     chemotherapy. Subjects will receive surgical treatment or combined chemoradiation therapy     based on the subject's apparent clinical response. Spared use of radiation therapy for     selective patients who have a complete response to induction chemotherapy could improve well     being of this patient population without compromising survival.   "
248724|NCT01111955|"     The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects     on fasting plasma glucose (FPG).   "
248725|NCT01111968|"     This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity     of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.   "
248726|NCT01111981|"     The purpose of this study is to ascertain the safety and efficacy of      Clobetasol Propionate 0.05% E Foam in the treatment of Central Centrifugal      Cicatricial Alopecia.   "
248727|NCT01111994|"     The purpose of this study is ascertain the efficacy and safety of Clindamycin      Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post      Inflammatory Hyperpigmentation in patients with skin of color.   "
248728|NCT01112007|"     The purposes of the study are to evaluate the relative contributions of insulin resistance     and renin-angiotensin-aldosterone system to blood pressure (BP) in subjects with     prehypertension. This is a cross-sectional study. Anthropometric and BP measurements will be     performed in 50 prehypertensive subjects. The subjects will receive a 75-g oral glucose     tolerance test and a postural stimulation test for the measurements of insulin resistance,     plasma rennin concentration and aldosterone level. Log (ISI0,120), an insulin sensitivity     index from the oral glucose tolerance test, will be calculated. Statistical analyses will be     performed to compare the degree to which aldosterone and Log (ISI0,120) predicted systolic     and diastolic BP in these prehypertensive subjects.   "
248729|NCT01112020|"     The purpose of this study is to determine the contents of a chlorhexidine-containing dressing     after use.   "
248730|NCT01112033|"     In this project, the investigators aim to study the role of biliverdin reductase A (BLVRA) in     HCV infected patients prior and during/after standard antiviral therapy in association with     viral clearance, disease progression and treatment response and in comparison with healthy     subjects.   "
248731|NCT01112046|"     This is a prospective randomized trial that aimed to compare the short-term clinical outcomes     and systemic inflammatory/cytokine responses of endoscopic submucosal dissection versus     laparoscopic resection for early colorectal neoplasms that are not amenable to en bloc     endoscopic resection with conventional techniques.   "
248732|NCT01112059|"     The purpose of this study is to examine the role of a well-known and well-tolerated     antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized.     This antibiotic does not effectively treat the bacteria in airways of cystic fibrosis     patients, but may reduce the activity of inflammatory molecules in the disease.   "
248733|NCT01112072|"     This study will determine the efficacy of corneal collagen crosslinking (CXL) combined with     Intacs for the treatment of keratoconus and corneal ectasia. The goal of CXL is to decrease     the progression of keratoconus, while Intacs has been shown to decrease corneal steepness in     keratoconus. This study will attempt to determine the relative efficacy of the two procedures     either performed at the same session versus CXL performed 3 months after Intacs.   "
248734|NCT01112085|"     The objective of this study is to investigate if the drug ranibizumab administrated by     microdose injection into the eye is safe and effective to treat diabetic macular edema.   "
248735|NCT01112098|"     The purpose of this exploratory study is to test novel, mailed, low-cost, direct-to-patient     intervention materials (i.e., a personalized letter and osteoporosis information pamphlet)     designed to increase rates of dual energy X-ray absorptiometry (DXA) utilization and improve     osteoporosis quality of care.   "
248763|NCT01112462|"     This study is designed to assess bioequivalence between two paracetamol/ phenylephrine     combination products.   "
248736|NCT01112111|"     This study is designed to compare the efficacy of a novel stimulation protocol with the     conventional low dose step-up and step down regimens in older than 30 years PCOS patients     undergoing in vitro fertilisation. The novel regime was proposed under the basis of the     combined effectiveness of the two standard protocols to induce a uniform follicular growth     and forms a continuation to the author's previously published results examining a similar     approach in younger PCOS candidates. In total 225 patients have been recruited for this     study. The stimulation protocol will be assigned under the basis of prospective randomization     using sealed and numbered envelopes. All patients will be down regulated using a     desensitisation agent administered on day 2 of spontaneous or induced withdrawal bleeding.     The initial dosage in the low dose step-up regimen (group A) will be 150 IU/d of FSH for the     first 6 days followed by an increase of 75 IU thereafter. In the step-down regimen (group B)     patients will administer a starting dose of 300 IU/d of FSH for the first 3 days followed by     a decrease to 225 IU/d for the next 3 days. This dosage will be further decreased to 150 IU/d     or sustained at 225 IU (according to the initial response) until the day of the hCG     injection. Group C, patients received 225 IU on day 1 followed by a decrease to 150 IU on day     2. On day 3 the dosage will be increased back to 225 IU. This alternation of injection dosage     will be followed until day 6. According to the initial ovarian response the dosage will be     sustained at 225 IU/d or 150 IU/d until the day of the hCG injection. The 10,000 IU hCG will     be administered when at least two follicles had reached a mean diameter of 18 mm and the     serum E2 levels were consistent with the ultrasound findings. Egg retrieval will be     undertaken at 35 hours after the administration of the hCG injection. Oocytes recovered will     be inseminated 4 hours post egg collection. Patients will receive 3 embryos on the third day     of development. The luteal phase will be supported by progesterone suppositories starting on     the day of the egg collection. A positive outcome will be detected by a serum β-hCG analysis     13 days after embryo replacement. The presence of a fetal heart pulse on ultrasound 3 weeks     later confirmed a clinical pregnancy.   "
248737|NCT01112124|"     The purpose of this study is to assess the typical behavior of children ages 15 months to     five years around a microwave oven. The UCH Burn and Complex Wound Center has observed scald     burn injuries in young children operating and/or removing hot liquids from microwave ovens.     The knowledge we hope to gain is the developmental age that a child is able to open and/or     operate a microwave oven safely. This work may influence future microwave oven design to     protect young children from microwave-related scald burn injuries. These injuries have     resulted in visits to the emergency room, stays in the hospital and debridement and skin     grafting procedures in the operating room.   "
248738|NCT01112137|"     Context: Soluble CD40 ligand (sCD40L) released from activated platelets induces inflammatory     transformation of the vascular endothelium and is an independent predictor of cardiovascular     events. Arterial hypertension is associated with platelet activation, increased sCD40L levels     and endothelial dysfunction suggesting that inhibition of platelet-derived sCD40L release may     improve endothelial function and lower blood pressure (BP).      Objective: To determine the effects of clopidogrel on sCD40L, endothelial function and BP.      Design: Randomized, controlled, investigator-blinded, parallel-group, 2-phase trial in     patients with coronary artery disease and essential arterial hypertension and those without     hypertension.      Intervention: Participants receive a single 600-mg clopidogrel loading dose (phase I)     followed by a daily 75-mg clopidogrel maintenance dose over 28 days (phase II).      Outcome Measures: Primary outcome measure is the change in BP from baseline. Secondary     outcome measures are changes in biomarkers of platelet and endothelial function and their     correlation with BP.   "
248739|NCT01112150|"     The investigators hypothesize that leg edema will decrease rapidly when using the NormaTec     pump, patients will lose weight, will feel better, will be less prone to infections in their     legs and to congestion of the liver. Temporary elevation of intravascular fluid volume by the     mobilized edema fluid returned to the intravascular space by pumping may increase cardiac     output and renal perfusion and in addition it may distend the right atrium and ventricle thus     inducing BNP secretion. Both mechanisms may promote excess fluid removal by the kidneys.   "
248740|NCT01112163|"     Enhanced external counter pulsation (EECP) is a procedure performed on patients with ischemic     heart disease. The treatment improves physical capacity and relieves angina pectoris. It is     suitable for patients with persistent angina pectoris despite and for patients not amendable     for coronary revascularization. Some studies demonstrate a relationship between diastolic and     systolic blood pressure ratio (d/s ratio) and the effect of EECP.      The aim of the investigators study is to understand the effect of EECP on left ventricular     systolic and diastolic function assessed by trans-thoracic echocardiography (TTE).      Hypothesis: EECP improves left ventricular systolic and diastolic function. There is a     relationship between d/s ratio and aortic arterial stiffness EECP improves left ventricular     diastolic function Standard TTE would be performed prior the EECP procedure, which lasts 60     min., and repeated every 15 minutes. Moreover the investigators would measure pulse wave     velocity, a measure of aortic arterial stiffness, in order to investigate the relationship     between the d/s ratio and arterial stiffness.      The patients would be recruited among former study patients who have undergone EECP before.     20 patients with the best acoustic conditions would be selected and invited to enroll into     the study.   "
248741|NCT01112176|"     The current study is aimed at determining the normal response to increasing heart rates. For     this purpose, atrial pacing will be used to increase heart rate.   "
248742|NCT01112189|"     The post-mastectomy lymphedema is a complication of removal of the breast and nodal plexus     that causes accumulation of lymph and subsequent enlargement of the upper limb. It is the     most common complication of all attributable to mastectomy with axillary dissection and which     occurs in one third of patients who undergo radical mastectomy and radiotherapy     post-operation. Currently the treatment of lymphedema of the upper limb is mainly the use of     compression stockings, the use of pneumatic compression pumps and physiotherapy.      Multiple reports indicate that endothelial progenitor cells (EPC) can differentiate into     various cell lines, reproduced and participate in neoangiogenesis. This study was conducted     in the General Surgery Service, of the Hospital Universitario Dr. José Eleuterio González     and proposes the EPC obtained autologous transplantation of bone marrow for the treatment of     postoperative lymphedema in upper limb following axillary lymphadenectomy through the     stimulation of lymphatic neoangiogenesis. The investigators studied 20 female patients over     18 years after axillary lymphadenectomy. The objective is to develop an innovative and     definitive treatment for these patients and to analyze the costs and complications that this     treatment may have.   "
248743|NCT01112202|"     Dabigatran represent a new class of promising anticoagulation agents. As an oral direct     thrombin inhibitor it has been effective in preventing venous thromboembolism in patients     undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the     ex-vivo effects of Pradaxa® on different coagulation parameters.   "
248774|NCT01112618|"     This non-interventional study is planned to identify the subjects with severe luteinizing     hormone (LH) deficiency in the daily practice. The results will be used for the Periodic     Safety Update Report, which is to be regularly sent to the European Medicines Agency (EMEA)     and the responsible German Higher Federal Authority (BfArM).   "
248744|NCT01112215|"     Azathioprine is still considered the treatment of choice for the non-renal manifestations of     systemic lupus erythematosus (SLE) with an estimated efficacy of 45%.Recently, several     studies have demonstrated the efficacy of mycophenolate mofetil/enteric-coated mycophenolate     sodium in those cases, but so far, no controlled, randomized comparative study between the     two drugs has been conducted. The aim is to perform a randomized, controlled, phase III/IV     study comparing enteric-coated mycophenolate (ECMs) with azathioprine for induction and     maintenance therapy of the non-renal manifestations of SLE. Methods: Patients with non-renal     SLE flares (SLEDAI≥6 and/or BILAG o 2B refractory to full doses of hydroxychloroquine and     prednisolone (≥10 mg/d) or with relapsing flares will be included. Patients will be     stratified according the flare severity (moderate (SLEDAI<12)-severe (SLEDAI≥12)) and     randomized (1:1) into two groups of treatment, EMCs (2gr/d) or AZA (2-2.5mg/kg/d) according     to TMPT levels for 6 months. Dose will be progressively tapered based on clinical response up     to completing a year of treatment. The main aim is the percentage of complete remission     achieved ((SLEDAI <4 and/or absence of any BILAG A o B) at week 12 and 24 for moderate and     severe flares, respectively. Secondary objectives include evaluating the reduction in the     steroid requirement, number of flares post-treatment, effect on the biological parameters,     and impact on quality of life, damage and drug safety. To detect a 20% difference between the     two drugs with a 80% statistical power (0.05 alpha error), considering a follow up loss of     20%, a total of 240 patients is required.   "
248745|NCT01112228|"     This study will assess various published staging tools to assess the health impacts of     obesity on individuals. The aim is to identify benefits and drawbacks, and thus help Obesity     Centres and GPs better assess obese individuals as well as better identify who benefits most     from having weight loss treatment.   "
248746|NCT01112241|"     This study has been designed to provide a substantial evidence of acute bronchodilator     responsiveness to two sequentially inhaled drugs, a beta2-agonist (i.e., albuterol) and an     anticholinergic (i.e., tiotropium bromide), in a group of patients who developed obliterative     bronchiolitis after hematopoietic stem cell transplantation.   "
248747|NCT01112254|"     The purpose of this study is to evaluate the diagnostic performance of MRI±biopsy to optimize     resection of Ductal Carcinoma In Situ (DCIS) breast cancer.   "
248748|NCT01112267|"     The purpose of this study is to evaluate the efficacy and safety of extended release (ER)     tramadol hydrochloride (HCl)/acetaminophen compared with placebo in participants with chronic     (lasting a long time) low-back pain.   "
248749|NCT01112280|"     The investigators plan to conduct a multi-center, randomized controlled trial to investigate     the efficacy of cap-assisted chromoendoscopy as a screening test for colorectal polyp, and     the impact on 3-year polyp recurrence rate. This study will be performed using web-based     research network, e-VELOS in Korea.   "
248750|NCT01112293|"     This study is being conducted to evaluate the overall safety and effectiveness of an     investigational drug, GC1008, in patients with mesothelioma. An investigational drug is one     that has not been approved by the FDA. Approximately 40 people will be enrolled on this study     at the University of Pennsylvania (Main Institution/Coordinating Site) and the University of     Chicago (Participating Institution). We expect about 20 subjects to be enrolled at each     institution.   "
248752|NCT01112319|"     The objective of this clinical trial is to evaluate the pain relief and daily functioning     improve, in patients suffering of Osteoarthritis of knee, with HOT/COLD/ Electro therapy     during physiotherapy treatment   "
248753|NCT01112332|"     The objective of this clinical trial is to determine normative Percentage     Body-Weight/Weight-Bearing Values and Weight-bearing Gait Characteristics in different     physiologic conditions        1. Values in increasing speeds from walking to running.        2. Changing resistance and incline on an elliptical trainer        3. Ground jogging.        4. Stair climbing.        5. Treadmill running.        6. Walking.   "
248754|NCT01112345|"     The present study aims to assess the adherence to therapy with interferon beta-1a (Rebif®)     and at investigating potential factors that are involved in its outcome, in a representative     sample of patients with relapsing remitting multiple sclerosis (RRMS), under real life     conditions.   "
248755|NCT01112358|"     This was a prospective, randomised, comparative with parallel control, Phase 2 exploratory     trial to assess the efficacy and safety of mid follicular Luveris in 60 women at risk of poor     response undergoing COS prior to ICSI with Gonal-f and Cetrotide.   "
248756|NCT01112371|"     The purpose of this study is to investigate the efficacy of Contractubex® Gel, containing     extractum cepae, allantoin and heparin, in the treatment of scars after abdominal Caesarean     section compared to untreated scars after abdominal Caesarean section.   "
248757|NCT01112384|"     The purpose of this study is to find out what effects a new drug SB939 has on you and your     sarcoma.      This research is being done because there is a need for better treatment options for advanced     or recurring sarcoma.      SB939 has been shown to shrink tumours in animals and some people and seems promising but it     is not clear if it has any positive effects in sarcoma.   "
248758|NCT01112397|"     This study is being conducted to assess the safety, tolerability and PK of AZD1480 in     patients with advanced solid malignancies.   "
248759|NCT01112410|"     The investigators hypothesise that nebulised hypertonic saline (6%) will increase the volume     of sputum expectorated over a 24 hour period compared to nebulised isotonic saline (0.9%) in     patients with mild to severe stable bronchiectasis.   "
248760|NCT01112423|"     The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects     on LDL cholesterol (LDL-C)   "
248775|NCT01112631|"     The patients from 12 centers were included into the study. pN2 patients received PORT, pN1     patients did not. PORT was 3D-planned and consisted in 54-56 Gy in 27-28 fractions. One month     after surgery, all patients completed EORTC QLQ C-30 questionnaires and had pulmonary     function tests (PFT); cardiopulmonary symptoms were assessed by modified LENT-SOM score. Two     years after, all patients free of disease repeated the same examinations. Changes in QLQ,     LENT-SOM score and the results of PFT were compared for patients receiving and not PORT.   "
248887|NCT01114087|"     Evaluate the possible deleterious effects of tyrosine kinase inhibitors on sperm     concentration, after 6 months of therapy, which corresponds to 2 cycles of spermatogenesis     and on the sperm nuclear integrity. The main comparison criterion will be the mean difference     in sperm concentration before and after the 6 month treatment.   "
248764|NCT01112488|"     Currently there is a lot of literatures on stroke rehabilitation and post-discharge therapy.     However, there are few evidence based guidelines on patient engagement after stroke in the     post-rehabilitation community phase. There is evidence from stroke studies that stroke     patients with mild to moderate disability, discharged early from an acute hospital unit can     be rehabilitated in the community by an interdisciplinary stroke rehabilitation team and     attain similar functional outcomes when compared to patients receiving in-patient     rehabilitation. There is strong evidence that additional hospital based outpatient therapy     improves short term functional outcomes compared to routine care over short term. Although     meta-analyses have examined the efficacy of self management education programs, the     interpretation of such reviews is limited by heterogeneity in populations and interventions     and the limited range of outcomes measured. Few randomized controlled trials have found a     reduction in health service utilization, such as incidences of hospitalization (in patients     with chronic lung disease, heart disease, stroke and arthritis) as a direct outcome of     attending an education program. For self-management support to be effective and sustainable     in the community, it is postulated that initiatives simultaneously focus on supporting     patients to engage in self management and equipping health care professionals with the     necessary resources to assist them.   "
248765|NCT01112501|"     Aim of the study is to evaluate whether Tc-99m-ECD-SPECT/CT enhances early diagnosis of     dementia in two specific patient groups: (1) patient with mild cognitive impairment, and (2)     patient with possible symptoms and signs of frontotemporal dementia. Evaluation of SPECT/CT     data is performed both by visual and quantitative voxel-based analyses (Statistical     Parametric Mapping). The final diagnosis is based on up to four years clinical follow-up.   "
248766|NCT01112514|"     Standard white light endoscopy involves the passage of a thin, flexible camera into the colon     from the anus. Although standard white light endoscopy can detect most polyps and     precancerous areas in the gastrointestinal tract and colon, many studies have shown that even     the most experienced doctors, under optimal conditions, can miss up to 15-25% of precancerous     areas. Thus, there remains a clear need to develop new methods of improving standard white     light endoscopy. We are investigating whether indocyanine green (ICG) can serve to highlight     areas which are precancerous when the colon is visualized with a special cameral which shines     fluorescent light. Information from other studies suggests that this ICG agent may help to     visualize blood vessels flowing to precancerous areas in the colon. We are looking at the     ability of ICG, in combination with an endoscope which shines fluorescent light, to visualize     precancerous areas in the colon.   "
248767|NCT01112527|"     There are three arms to this study (A, B and C) The purpose of this research study during Arm     A is to see how much of PF-00299804 gets into the brain tumor. For many brain tumors, one     reason that chemotherapy drugs might not be effective is that the drug may not be able to get     into the brain tumor and kill the cancer cells. We will determine how much PF-00299804 gets     into the brain tumor by obtaining a sample of the tumor from the surgery that the participant     already has scheduled. The purpose of this research study during Arm B and C, is to determine     how well PF-00299804 works in killing cancer cells. PF-00299804 works by binding to specific     proteins found on the surface of some cancer cells that promote a growth signal. Blocking     this signal from reaching its target on the cancer cells may slow or stop the cancer from     growing.   "
248768|NCT01112540|"     The investigators primary outcome measure was the clinically important change in diagnostic     accuracy and physical examination in the morphine vs. placebo group. After follow up     information was obtained and patients data were recorded on the SPSS data chart, two blinded     coauthors (general surgeon and emergency physician) determined the clinically important     diagnostic accuracy and change in physical examination. They firstly defined clinically     important diagnostic errors, as any disagreement between the preliminary and final diagnosis     that might be expected to have adverse effect on the patient's general status. If coauthors     decided an instance of diagnostic error as clinically important, this was coded diagnostic     discordance for statistical analysis. While the preliminary diagnosis was determined as     accurate or not different from the final diagnosis, this was coded diagnostic accuracy for     statistical analysis. Secondary outcome measures included the need for rescue drugs at 30     minutes, the presence of at least one adverse event, demographic features and final diagnosis     of the patients.   "
248769|NCT01112553|"     We are looking for volunteers who suffer from acute migraine (<14 episodes per month) to     participate in a 2-visit brain imaging research study. The goal of the study is to observe     the effect of acute administration of Treximet during a migraine episode on the pain pathways     of the migraine brain. Visit 1 will consist of 1 hour, where participants will be signing the     informed consent form, completing questionnaires, meeting with the study physician, and     having QST (sensory testing to determine individual pain thresholds to a heat stimulus)     performed. Visit 2 will occur during a migraine episode. Volunteers will be asked to contact     the study team at the first onset of a migraine. Upon arrival at Visit 2, individuals will be     given an IV for blood draws. Once these the IV is in place, subjects will enter the MRI and     be asked to stay very still. Scanning will occur for about 20 minutes, and then subjects will     be given a Treximet tablet to combat their migraine. More scanning will follow Treximet     administration. Some scans will have no stimulation, and others will apply a heat stimulus     that subjects will rate using a pain scale. Seven 5-mL blood samples will be drawn throughout     the duration of the MRI session. Both Visit 1 and Visit 2 will be compensated.   "
248770|NCT01112566|"     The goal of the study is to identify the patients suffering from a mitral valve condition who     benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and     long-term relief of mitral valve regurgitation.   "
248771|NCT01112579|"     The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as     a chronic therapy for systolic heart failure.   "
248772|NCT01112592|"     We aim to study if pathological NETs formation could be the underlying pathology among     patients with recurrent infections and a normal screening of the immune system.   "
248773|NCT01112605|"     The purpose of this study is to define the standardization of the distance between the Sural     nerve & Achilles tendon, in otherwise healthy persons and athletes.   "
248776|NCT01112644|"     The primary objective for the 12-week Titration-/Maintenance Period is:      To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom     severity of RLS.   "
248779|NCT01112683|"     The purpose of this 16-week research study is to determine whether a drug called memantine     hydrochloride (memantine) has the potential to help improve memory and other cognitive     abilities of young adults with Down syndrome (DS). Memantine (Namenda®) is a drug approved by     the Food and Drug Administration (FDA) for patients with moderate to severe Alzheimer-type     dementia. About 40 persons of both genders with Down syndrome aged 18-32 years will take part     in this study. This is a randomized and double blind study. This means that subjects will     have a 50/50 chance of being assigned to receive either the memantine pills or placebo     (inactive pills). Neither the study participants nor the research personnel will know who is     receiving active medication or placebo. Based on memantine's mode of action, current     knowledge on brain pathology in persons with Down syndrome, and some preclinical data on     mouse models of Down syndrome, we hypothesize that memantine may improve test scores of young     adults with Down Syndrome on memory tests targeted at the function of the brain structure     called the hippocampus. This research project has three specific aims: 1) investigate whether     memantine has the potential to improve test scores on hippocampus-dependent measures in young     adults with Down syndrome; 2) investigate whether memantine has the potential to improve test     scores by these subjects on other cognitive measures; 3) investigate whether memantine is     well tolerated by these subjects.   "
248780|NCT01112696|"     The purpose of the study is to assess the performance of a new subcutaneous glucose sensor     over a seven-day sensor life when used with currently marketed Medtronic Diabetes devices. In     addition performance will be calculated for use of the new sensor with proposed new devices     using new calibration algorithms.   "
248781|NCT01112709|"     The aim of this Phase II Clinical Trial is to demonstrate the efficacy of social cognitive     theory (SCT) based intervention for initiating, and most importantly, maintaining resistance     training in older adults with pre-diabetes (i.e., impaired glucose tolerance or impaired     fasting glucose) to improve blood glucose regulation.   "
248782|NCT01112722|"     The study will identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with     diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using     Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global     Assessments and primary efficacy measure of relief of pain and inflammation over a 12 week     treatment period after randomization into the trial. Secondary efficacy is improvement of     mobility Treatment effect will be compared in a 2-1 Apitox vs active control   "
248783|NCT01112735|"     The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of     care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing     abdominoplasty.   "
248784|NCT01112748|"     The primary purpose is to study the predictive value of preserved nociceptors and large     afferent fibers and dynamic mechanical allodynia on the effect of lidocaine patch. The     primary outcome measure is the predictive role for these three measures for obtaining a     response to lidocaine. A responder is defined as a person with at least a 2-point pain     reduction to lidocaine (change in median pain intensity (measured on a 10 point numeric     rating scale) of pain from the baseline week to the last week of lidocaine treatment).     Secondary effect variable will be efficacy of lidocaine on pain reduction (baseline week     versus last week of each treatment) and pain relief (complete, good, moderate, slight, none,     or worse) for spontaneous and evoked pain, and effect on ongoing pain, brush evoked     allodynia, cold and warm allodynia, and pinprick hyperalgesia evaluated on each visit.   "
248785|NCT01112761|"     The purpose of this research is to determine whether athletes with concussion have changes in     cortical excitability.      Single and paired transcranial magnetic stimulation (TMS) can be used as reliable     neurophysiological marker of motor cortex reorganization in athletes with concussions.      This study also aims to determine whether modulation of cortical activity by a powerful     technique of noninvasive brain stimulation (tDCS) results in a different cortical response as     compared with sham tDCS.   "
248786|NCT01112774|"     The purpose of this study is to determine whether the novel treatment of transcranial direct     current stimulation (tDCS) could decrease the pain perception of those with spinal cord     injury.      We will also determine whether these changes are correlated with the clinical outcome (pain     reduction).   "
248787|NCT01112787|"     The purpose of this study is to evaluate the irritation level of tazarotene foam after 21     days of exposure on the skin of healthy volunteers.   "
248788|NCT01112800|"     Anthracycline antibiotics are included in the chemotherapy regimens of approximately 82% of     patients with bone cancer and 44% of those with soft tissue sarcoma diagnosed in childhood or     adolescence. Impaired cardiac function occurs after treatment with anthracyclines. The     frequency of impairment increases with increasing cumulative dose. There are inadequate data     regarding the relationship between doxorubicin administration and changes in serum levels of     cardiac troponin T (cTn-T) or I (cTn-I), N-terminal (NT) brain natriuretic peptide (BNP), or     tissue Doppler imaging parameters.      This non-therapeutic study proposes a prospective, single arm study of serial changes in     tissue Doppler imaging parameters, cTn-T and NT-BNP in children and adolescents with     malignant bone and soft tissue tumors whose planned chemotherapy includes treatment with ≥     375 mg/m2 of doxorubicin.      The proposed study will rigorously evaluate the usefulness of serial determinations of tissue     Doppler imaging, cTn-T and NT-BNP for very early identification of anthracycline-related     myocardial injury. Demonstration that one or more of these markers identifies subclinical     myocardial damage and that biomarker or tissue Doppler imaging parameters exhibit a     dose-response relationship with cumulative doxorubicin dose would facilitate intervention     trials in patients at risk for anthracycline cardiomyopathy.   "
248805|NCT01113021|"     The hypothesis of this study is that a chronic program of physical strength      training, associates to effects of low level laser therapy (LLLT) can,      possibly, provide changes in genic expression of muscle and to promote an      enhancement of anaerobic muscle performance in humans.   "
248806|NCT01113034|"     The primary objective is to evaluate whether DAS181 is safe in subjects with well-controlled     asthma or bronchiectasis.   "
248859|NCT01113723|"     The purpose of this study is to evaluate whether tracheal intubation with the CMAC device     decreases the time required for intubation as compared to intubation with the fiberoptic     bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the     fiberoptic bronchoscope are currently commonly used in standard of care practices in the     intubation of patients with cervical spine injury.   "
248789|NCT01112813|"     Stroke is the leading cause of adult disability and the third leading cause of death in     Canada. Most stroke survivors live with residual impairments that diminish independence and     quality of life. This may include vascular cognitive impairment (loss of ability to plan,     think and reason) which can lead to dementia and loss of mental and functional independence.      The current treatment to reduce stroke induced brain tissue injury is limited to     thrombolytics (clot busters), a therapy useful only if given in the first hours following     stroke. One major new approach aims to reduce cell death after stroke by targeting the     ongoing tissue loss initiated by the stroke. The tissue can be maintained by interfering with     later neurochemical processes that are activated by stroke, potentially through activating     natural substances in the brain that help survival and growth of nerve cells (neurotrophic     factors).      The recent recognition of lithium as a neurotrophic agent has generated the first studies of     lithium treatment for managing brain diseases. Clinically, lithium has now been shown to     increase brain gray matter volume in bipolar patients. This effect is potentially important     in stroke because gray matter loss has been implicated in the development of cognitive     impairment after stroke, a result of the series of brain processes that are activated by lack     of oxygen due to stroke. Our primary objective is to examine the effects of lithium on total     brain gray matter volume in the post-stroke population, as measured by volumetric magnetic     resonance imaging (MRI) with the hope that lithium may increase gray matter volume in     post-stroke patients and lead to greater cognitive and functional rehabilitation. This study     will provide valuable information on the tolerability of lithium, and its effects on clinical     outcomes relevant to stroke, providing the information needed for designing a large-scale     clinical trial.   "
248790|NCT01112826|"     The primary objective of this study is to compare disease-free survival (DFS) of patients     with triple negative breast cancer randomised to treatment with standard adjuvant     chemotherapy alone or to standard adjuvant chemotherapy followed by 1 year of Capecitabine     (Xeloda) metronomic therapy.   "
248791|NCT01112839|"     The purpose of the ENERGY trial is to explore whether two different programs that are focused     on weight management, through increased exercise and a healthy diet, are feasible, and have     an impact on body weight, quality of life and fatigue. Since obesity among breast cancer     survivors is associated with recurrence and other co-morbidities, those will be assessed and     their impact calculated. Blood samples will be collected to enable analysis of potential     mechanisms and differential response across subgroups.   "
248792|NCT01112852|"     Previous studies showed that combination of endoscopic therapy with vasoconstrictor is better     than either vasoconstrictor or endoscopic therapy alone in achieving the successful     hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance     the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation     (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of     choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve     hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding     due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal     ulcers and bleeding by a proton pump inhibitor may be more logical than using a     vasoconstrictor after cessation of bleeding by EVL.   "
248793|NCT01112865|"     Convenience and preference for the new Mark VII pen compared to the current Genotropin pen     will be assessed using a questionaire. it is expected that the new pen will be preferred or     at least no different to the current pen.   "
248794|NCT01112878|"     The purpose of this research is to investigate the non-opioid (non-narcotic) pain-relieving     medications clonidine and gabapentin to see if they decrease the amount of opioid pain     medications needed after surgery, thereby reducing opioid-related side effects, and time     required to return to normal activities of daily living after surgery.   "
248795|NCT01112891|"     Background: Vitamin D is vital throughout pregnancy and lactation for both maternal and     infant health. Health Canada recommends women take the AI of 5ug/day of vitamin D during     pregnancy, however, it is unknown how much vitamin D is necessary to ensure both mother and     baby reach a vitamin D serum concentration of 25OHD>75nmol/L.   "
248796|NCT01112904|"     Docosahexanoic acid (DHA) is concentrated in the human brain. Before birth, DHA is     transferred across the placenta, but transfer depends on maternal DHA intake. After birth,     DHA is provided by breast milk or the child's diet. This study addresses whether DHA intakes     are adequate to support human brain development.      In a previous study N-3 Fatty Acid Requirements for Human Development (C03-0242), pregnant     women were randomly assigned to 400 mg/day DHA or placebo from 16 weeks of gestation until     infant delivery. Blood DHA in gestation, and infant development to 18 months were assessed.     This follow-up study will assess if maternal DHA in gestation has long-term influence on     child development when assessed at 5 years and the impact of the child's own diet.   "
248797|NCT01112917|"     The investigation is designed to verify that clinical use of the vena cava filter does not     raise new questions of safety or effectiveness compared to currently-marketed permanent     filters.   "
248798|NCT01112930|"     In humans, docosahexanoic acid (DHA) is concentrated in brain. After birth, DHA is obtained     from breast milk or the child's diet. The investigators are studying whether DHA intakes in     young children are adequate to support brain development. This is a cross-sectional study of     children 5-6 years-old.   "
248799|NCT01112943|"     The hypothesis of this study was that acupuncture in conjunction with standard care of     pulmonary rehabilitation improves outcome measures compared to pulmonary rehabilitation     alone.   "
248800|NCT01112956|"     The purposes of this study are:        -  To determine the accuracy of commercially available serologic assays in diagnosing          patients with herpes simplex virus type 2 (HSV-2);        -  To assess the sensitivity and specificity of the commerical assays using HSV-2 western          blot as the gold standard in a diverse patient population;        -  To develop testing strategies and recommendations for screening asymptomatic populations          for HSV-2.   "
248801|NCT01112969|"     This is an intervention study for informal caregivers of adult patients with an acquired     brain injury (stroke, traumatic brain injury or cerebral haemorrhage). It will determine     whether an internet-based supportive coaching offers benefits to the caregivers in their own     process of coping in the aftermath of a brain injury of a close relative. We expect the     internet-based supportive coaching to be more effective in the treatment of emotional     distress reactions and caregiver burden than the treatment as usual.   "
248802|NCT01112982|"     The purpose of this study is to show that patients with gout suffer from chronic inflammation     of their joints, observable by MRI, even in the absence of symptomatic gouty attacks.     Secondary end-points of this study will include analyzing the effects of uric acid-lowering     therapy (specifically with the FDA approved medication Febuxostat) in a subgroup of patients,     checking for the presence of inflammatory markers to see if there is any correlation with the     proposed chronic inflammation, and evaluating for other characteristic findings of gout on     MRI.   "
248808|NCT01113060|"     Aspirin is an effective medicine for prevention of heart attacks in patients with coronary     artery disease and works by preventing clots from forming. In previous studies aspirin has     been found to be ineffective in between 2% and 65% of patients but none of these studies have     looked specifically at coronary artery disease patients in Ireland. This study is being done     to identify the percentage of patients in Ireland whose aspirin is not working effectively     and help identify factors that could be used to target interventions to increase aspirin's     effectiveness in Irish patients.   "
248809|NCT01113073|"     Fluid administration is a daily intervention on the intensive care unit to improve cardiac     output (CO) and stabilize circulation in critically ill patients. Simultaneously, the volume     status of the patient is very difficult to assess. Too little volume leads to inadequate     organ perfusion followed by ischemia and organ failure. Too much volume may worsen heart     failure and cause pulmonary and peripheral edema and contribute to further tissue injury and     organ dysfunction. Although dynamic indices have been shown to be more accurate predictors of     fluid responsiveness, this relevant and complex task is usually guided by static clinical     variables and the specialist's interpretation due to the fact that the interpretation of     dynamic parameters is not fully developed and that they are not universally available. This     lack of understanding is partially because of the complex interaction with mechanical     ventilation. The investigators hypothesize that knowing the distribution of ventilatory     pressures will make it possible to index dynamic parameters to tidal volume and improve their     predictive value concerning the volume status of the patient. In addition, it would be of     interest to be able to predict fluid responsiveness in a non-invasive way, especially in     critically ill patients. Up to now, continuous non-invasive cardiac output monitoring using     Nexfin in critically ill patients has not been validated and also not tested for its ability     to predict fluid responsiveness. The present research proposal evaluates the possibility and     accuracy of the model flow analysis obtained by non-invasive finger arterial pressure     measurements to determine fluid responsiveness using passive leg raising. It will also be     compared to a more invasive method (that is currently used in the clinic) to assess its     ability to measure absolute CO levels accurately. It may make it possible to assess fluid     responsiveness in a non-invasive and patient friendly way.   "
248810|NCT01113086|"     The purpose of this research is to determine whether repetitive sessions of transcranial     direct current stimulation (tDCS) to the prefrontal cortex can enhance the cognitive,     affective and motor functioning of those with Parkinson's Disease.      In this study we will compare active tDCS with sham tDCS. Each subject will receive two     consecutive weeks of stimulation (Monday through Friday). A battery of neuropsychological and     affective tests will be administered throughout the duration of the study.   "
248811|NCT01113099|"     We hypothesize that when compared to usual care a greater proportion of hospitalized diabetic     patients who are candidates for cholesterol lowering will be discharged with a prescription     for a statin if their physicians are contacted by a pharmacist to discuss treatment     guidelines.   "
248812|NCT01113112|"     The purpose of this study is to understand relationships between behavioral factors,     hormones, and chemicals produced by the body that may help tumor growth in ovarian cancer.   "
248813|NCT01113125|"     Most children with cancer need a central venous catheter. These catheters are typically     placed on the anterior thorax, where the risk of hypertrophic scarring and keloid development     is greatly enhanced. A significant part of the children who have survived childhood cancer     are troubled by their scars.      Topical glucocorticoid treatment is known to induce a reduction of the collagen in the     connective tissue.      The investigators hypothesize that treatment with topical glucocorticoids for one week before     and three weeks after removal of a central venous catheter, will reduce the formation of     hypertrophic scarring and keloid development in children.   "
248814|NCT01113138|"     The present study is part of a project titled 'Magnesium in asthma and chronic obstructive     pulmonary disease'. The hypothesis of the main project is that daily magnesium supplement     will benefit patients with asthma and chronic obstructive pulmonary disease.      The aim of this part of the project is to study the pharmacokinetics of the following two     magnesium supplements:        -  Mablet (dietary supplement)        -  Magnesium Sulfate (solution for infusion)   "
248815|NCT01113151|"     The present study is part of a project titled 'Magnesium in asthma and chronic obstructive     pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement     will benefit patients with asthma and chronic obstructive pulmonary disease.      The aim of this part of the project is to reveal possible beneficial effects of daily     magnesium supplement for severe asthmatics, refractory to conventional treatment.   "
248816|NCT01113164|"     Sertraline, a serotonin-specific reuptake inhibitor (SSRI) that increases basal serotonin     levels, was shown to reduce alcohol consumption in lower risk/severity and later onset (LOA)     but not higher risk/severity earlier onset alcoholic individuals (EOA). By contrast,     ondansetron, a 5-HT3 receptor reduced alcohol consumption in EOAs but not LOAs. To explain     this contrast in clinical efficacy, one approach suggests that differential serotonergic     response is based on a functional polymorphism of the 5-HTTLPR promoter region of the     serotonin re-uptake transporter (SERT). These alleles have typically been classified as     biallelic genotypes: LL, SS and SL. The LL variant is postulated to be associated with EOA     and the SS/SL variants associated with LOA. To test this hypothesis the investigators     therefore propose to match and mismatch serotonergic treatments to genetic polymorphic     variants [in 132 non-treatment seeking alcohol dependent volunteers] in a double-blind     placebo controlled 2 x 2 design human laboratory study. The investigators propose to     randomize non-treatment-seeking alcohol dependent persons based on their 5'-HTTLPR variant     genotype (LL or SS/SL) into one of two counterbalanced arms: participants in the first arm     (LL) will first receive one drug (either 200mg/day of sertraline or ondansetron 0.5mg/day)     for three weeks followed by an alcohol self-administration experiment (ASAE), [with a 1 week     down-titration period if sertraline received first, during the first week of the placebo     period] then receive placebo for two more weeks (this will be a single-blind portion to use     as a comparison group and to wash out the pharmacodynamic effects of the first drug) followed     by a second ASAE. Participants will then receive the second drug for three weeks followed by     a third ASAE [all will receive medication for an additional 1 week period and those receiving     sertraline last will be down-titrated]. Participants in the second arm (SS/SL) will receive     the same medications in the same balanced design. Individuals in both arms will receive     weekly medication management to enhance medication adherence. The long-term objective of this     research is to prospectively examine serotonergic treatment matching for alcohol dependence     based on genotyping. Of equal importance, the investigators also recognize the strong     contribution of additional genetic and environmental influences on alcohol consumption.   "
248817|NCT01113177|"     Temporomandibular joint (TMJ) arthritis is known to alter the mandibular development in     children diagnosed with juvenile idiopathic arthritis. In a number of cases a genuine     breakdown of cartilage and bone is seen in the affected joint which leads to asymmetric     mandibular growth in the affected side. In cases of unilateral TMJ involvements severe     mandibular asymmetric mandibular growth deviations are seen. We hypothesize that these growth     deviations can be minimized and controlled by the use functional orthodontic appliance     therapy.   "
248842|NCT01113502|"     This is a phase I/II open label study being conducted to evaluate the overall safety and     initial effectiveness of an investigational drug, Eltrombopag in patients who are 60 years of     age and older and who have Acute Myelogenous Leukemia (AML). Eltrombopag is an     investigational drug, which means it has not been approved by the U.S. Food and Drug     Administration (FDA) for use in this type of disease. Approximately 35 people will be     enrolled on this study at the University of Pennsylvania   "
248818|NCT01113190|"     Screening, brief interventions, and referral to treatment (SBIRT) for drug use/abuse offers     opportunities for early detection, brief intervention/treatment, and substance use treatment     referrals for patients in medical settings. Although SBIRT components, particularly screening     and brief interventions, have been shown to be effective strategies for addressing alcohol     misuse in primary care, data are limited on using all of the components of SBIRT for     drug-using patients, particularly in the Emergency Department (ED). Further, because of the     often chaotic environment of EDs, many logistical and practical impediments exist for the     adoption of the entire SBIRT model in this setting.   "
248819|NCT01113203|"     The study aimed to evaluate the chronic and acute effects of high-intensity resistance     training on blood pressure and its hemodynamic and neural determinators in healthy     normotensive older subjects.   "
248820|NCT01113216|"     This research is being done to find the genes and other factors that are responsible for     differences among persons with cystic fibrosis. We are particularly interested in the factors     that relate to the development of Cystic Fibrosis Related Diabetes (CFRD).   "
248821|NCT01113229|"     To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum     haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.   "
248822|NCT01113242|"     Cognitive disorders in Parkinson's disease (PD) are not as obvious as cognitive disorders in     Alzheimer disease and their diagnosis tends to be delayed. If neuropsychological assessment     of cognitive decline in Parkinson's disease is well established, the thresholds of cognitive     testing corresponding to a dementia are unknown. Recently, new diagnosis criteria of dementia     associated with PD have been proposed by the movement disorder society. In this study two     groups of patients with idiopathic PD will be separated and compared according to their Mini     Mental State Examination (MMSE) score (upper or lower than 26). Included patients will have     clinically idiopathic PD, will be over 65 years old and will present cognitive complain.     Cognitive and mood disorders as well as motor symptoms will be assessed using validated     scales and a neuropsychological assessment dispatched in two visits will be performed .     Differences in the distribution of data from the two groups of patients will be assessed in     statistically analysis with non parametric tests. The purpose of this study is to determine     the most effective tests and their threshold value corresponding to a pathological cognitive     decline.   "
248823|NCT01113255|"     The purpose of this study is to evaluate the ability of a device reproducing patients'     respiratory characteristics to select in-VITRO the most appropriate ventilator for a given     pathology.   "
248824|NCT01113268|"     Our main goal is to create a prospective cohort of 1500 patients with a first large     myocardial infarction allowing us, in a second step, to identify susceptibility genes for the     progression of patients towards chronic heart failure using a candidate gene/candidate     pathway approach. Our main hypothesis is that there is, for a given initial biomechanical     stress (duration of the ischemic episode, size of the infarcted area, etc.), a variation in     the individual susceptibility to develop left ventricular remodelling and to progress towards     heart failure, and that this variation is linked to genetic variants between individuals.   "
248825|NCT01113281|"     Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing     BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against     tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas.     The new vaccine should be at least as potent as the current strain and should be safer than     BCG (Kaufmann, 2007a; Grode et al., 2005). The vaccine is formulated as live lyophilised     bacteria to be re-suspended before intradermal injection. The preceding clinical trial in 80     volunteers in Germany indicated immunogenicity and safety being sufficient for proceeding     with the clinical development. Hence, the current study is commenced in South Africa, a     country highly endemic for tuberculosis.      24 volunteers were randomly allocated to 4 groups each with 6 adult healthy volunteers.   "
248826|NCT01113294|"     To compare the efficacy of different procedures, identify the optimal procedure, ablation     sites, ablation endpoints and post-operative anticoagulation strategy, establish the optimal     treatment strategy for atrial fibrillation.   "
248827|NCT01113307|"     The primary objective of the study is to define procedures for the use of CureXcellTM in the     community through Clalit Health Services. Secondary objective is to evaluate the blinding     method in a subgroup of patients, which will be used in a future study named: a     multinational, multi-center, randomized, double blind, placebo controlled study for the     evaluation of the tolerability, safety and efficacy of CureXcell™ therapy plus adequate ulcer     treatment, in diabetic patients with ulcers in the lower extremities.      Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post     operative ulcer will be recruited to the study. Patients that have been recruited for the     study will be treated as required for their medical condition. As required, cultures will be     taken, IV or PO antibiotics will be given and debridement will be carried out. Patients will     be referred to catheterization, revascularization, or amputation as required and the decision     to do so will not be affected in any way by the study. CureXcellTM will be used as adjunct     treatment to good ulcer care (GUC).   "
248828|NCT01113320|"     Approximately twenty four (24) subjects will participate in this research trial. The research     trial will be conducted in approximately twelve (12) medical centers in the following     countries: Germany, France, South Africa, Austria and Canada. The research trial will last     until December 2011.   "
248829|NCT01113333|"     Primary Objective:        -  Assess the safety and tolerability of single intra-articular doses of SAR113945 in          patients with knee osteoarthritis.      Secondary Objective:        -  Assess systemic exposure of SAR113945 following intra-articular delivery.   "
248830|NCT01113346|"     This is a phase II double blind multicenter randomized placebo-controled clinical study aimed     to find out whether treatment with Filtrum-STI (orally administered 0,4g tablets) is safe and     effective in children with viral gastroenteritis. Filtrum-STI (lignin hydrolytic) is a drug     with a high absorbing ability, that binds and eliminates toxins, pathogenic microorganisms     and viruses. Filtrum-STI is inoffensive for mucous membranes, enhances colonic propulsion and     improves its natural microflora. The drug is not toxic and well combines with other     medication   "
253568|NCT01174459|"     The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol     Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine     medical practice.   "
248831|NCT01113359|"     It has been reported that mouse cytomegalovirus infection alone can elevate the blood     pressure in mice. Since HCMV has uniquely evolved with its human host, with little genetic     similarity to the animal CMV counterparts, and it only replicates in human, an     epidemiological study is required to define the relevance of HCMV infection and expression of     hcmv-miRNA-UL112 to the pathogenesis of essential hypertension.      The investigators found that hcmv-miR-UL112, a human cytomegalovirus (HCMV)-encoded miRNA,     was highly expressed in the hypertensive patients. Among the top miRNA target predictions,     the investigators demonstrate that IRF-1 is a direct target gene of hcmv-miR-UL112, along     with MICB that has been previously reported. Both IRF-1 and MICB play critical roles in     immuno/inflammatory and anti-infection response. Thus, the investigators speculated that     IRF-1 and MICB repression by hcmv-miR-UL112 could be considered a unifying mechanism that     evades the host response at several levels: antiviral, inflammatory, and immune. In addition,     there is an increasing evidence that IRF-1 may be important in apoptosis, angiogenesis,     neointima formation and the pathogenesis of vascular diseases. IRF-1 can up-regulate     angiotensin II type 2 receptor (AGTR2) that exerts antiproliferative and proapoptotic actions     and affects regulation of blood pressure. It has been reported that the targeted disruption     of the mouse AGTR2 gene resulted in a significant increase in blood pressure and increased     sensitivity to angiotensin II. The nitric oxide synthase expression and NO synthesis in     macrophages and distinct cardiomyocytes are induced and controlled by IRF-1 in response to     inflammation, important steps in vascular biology that may improve endothelial function and     inhibit smooth muscle cell migration, and a key pathophysiological event in hypertension.     Collectively, these reports support a strong relationship between IRF-1 regulation and     hypertension, indicating a potential role of hcmv-miR-UL112 and HCMV infection in the     pathogenesis of hypertension.Thus, the investigators want to investigate the potential link     between HCMV infection and essential hypertension.   "
248832|NCT01113372|"     Prospective, multicenter, randomized (two-arm 1:1), non-inferiority clinical evaluation     comparing 2 regimes of dual antiplatelet therapy (DAPT) with aspirin + clopidogrel following     percutaneous coronary intervention (PCI) with Endeavor Zotarolimus eluting stent (ZES) to     evaluate the impact of different regimes of DAPT on clinical outcomes in minimally selected     patients from the real-world clinical practice receiving the Endeavor ZES for the treatment     of coronary artery lesions. Patients undergoing percutaneous treatment with the Endeavor ZES     will be randomized in a 1:1 ratio to 2 regimens of DAPT including oral clopidogrel 75mg/day     for 3 months versus 12 months.   "
248833|NCT01113385|"     Focal Segmental Glomerulosclerosis (FSGS) is a devastating kidney disease which is difficult     to treat and carries a poor prognosis, with 50% of affected children progressing to end stage     renal disease (ESRD). The purpose of this study is to investigate oral galactose as a benign     treatment for FSGS in children. The investigators hypothesize that galactose, a simple milk     sugar thought to bind to the protein factor (FSPF) that causes FSGS thereby inactivating it     and stopping it from damaging the kidney, resulting in a reduction in glomerular permeability     to albumin and decrease in proteinuria in children with nephrotic syndrome secondary to FSGS.   "
248834|NCT01113398|"     The primary purpose of the study is to assess the response rate of AMG 102 and Avastin     treatment in subjects with advanced malignant glioma. Secondary objectives are to estimate     overall survival and 6-month progression-free survival rates in this population and to assess     the safety of this combination in this population.      Patients must have recurrent histologically confirmed diagnosis of World Health Organization     (WHO) grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3     prior progressions. Subjects will receive Avastin and AMG 102 every two weeks. Avastin will     be administered prior to AMG 102. Up to 36 adult subjects will take part in this study at     Duke.      In initial Phase I and II clinical trials, four potential Avastin-associated safety issues     were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage. The most     common side effect for AMG 102 have been nausea and fatigue.   "
248835|NCT01113411|"     The fracture of the proximal humerus represents 4% of the fractures encountered in clinics     and it must be treated surgically. Thus, the aim of the surgical treatment is to maintain     bone alignment, articular congruity, vascularization of the humeral head and provide a     painless shoulder with satisfactory function.      The objective of this study is to demonstrate the potential benefits of an early     rehabilitation program on shoulder function.   "
248836|NCT01113424|"     Bioequivalence between oral nicotine replacement products and Nicorette® gum.   "
248837|NCT01113437|"     Hypothesis- Omalizumab(humanized monoclonal anti-IgE antibody)improves disease control and     reduces bronchial mucosal inflammation in non-atopic asthma.      In order to test the above hypothesis, the investigators propose a placebo controlled, double     blind, parallel group study to obtain proof of principle that omalizumab exerts beneficial     effects on disease control in non-atopic severe adult asthmatics aged 18-60 years . Forty     patients will be randomized in a 1:1 ratio to receive omalizumab or matching placebo.     Following 12 weeks of treatment with omalizumab/placebo, and as this treatment is continued     for a further 8 weeks, anti-asthma treatment will be reduced. Dosages will be administered at     4 or 2 weekly intervals over a 16 week period (5 or 10 doses in total), which corresponds     with the time stated as necessary to judge efficacy of therapy according to omalizumab's     licensed indications in atopic asthma. Efficacy will be judged by clinical monitoring and by     bronchial biopsy to assess effects on bronchial inflammation and local IgE production.   "
248838|NCT01113450|"     The study aims to demonstrate the indices of quality of a Newborn Hearing Screening (NHS).   "
248839|NCT01113463|"     The goal of this clinical research study is to learn if TPI 287 can help to control     glioblastoma. The safety of this drug will also be studied.   "
248840|NCT01113476|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of Abraxane (nab-paclitaxel), Gemzar (gemcitabine), and Avastin (bevacizumab)     that can be given to patients with advanced cancer. The safety of this drug combination will     also be studied.   "
248841|NCT01113489|"     Although it is well known that the presence of uncontrolled inflammation in upper airways may     compromise the control of asthma and may favor the progression of asthma toward more severe     grades of disease, few studies addressed whether therapies aimed to control both upper and     lower airway inflammation may be more effective in controlling asthma. Markers of oxidative     stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of     children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with     the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a     facial mask (for treating both upper and lower airways) will be able to reduce the production     of oxidants as well as of IL5 in both districts thus promoting clinical and functional     improvements in mild intermittent asthmatic children. The results provided by this study will     contribute to further clarify the relationship between nasal and bronchial inflammation.   "
249032|NCT01115933|"     The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small     Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment     of subjects with ischemic heart disease caused by de novo lesions.   "
248847|NCT01113567|"     Two groups of patients with minimal hepatic encephalopathy will be studied. The treatment     group (n=17) will receive whole milk (24 g lactose) and the control group (n=17) will receive     lactose-free milk (3.5 g of lactose) two times a day for 21 days. Clinical history,     nutritional assessment, biochemical studies, psychometric tests, critical flicker frequency     and a quality of life questionnaire will be performed. The patient will be assessed weekly 21     days. An external monitor will control the randomization process in order to allocate the     patients into both study group and will not share the assignation codes with anyone until the     end of the study.   "
248848|NCT01113580|"     The purpose of this study is to determine whether the 2010/2011 Formulation Enzira vaccine is     safe and elicits an immune response to seasonal influenza in healthy adults.   "
248849|NCT01113593|"     The purpose of this study is to characterize the pharmacodynamic profile of Formoterol     Fumarate and Foradil Aerolizer   "
248850|NCT01113606|"     The aims of the Skin Product Assessment Research study were to (1) develop an infrastructure     and process for industry-sponsored, Plastic Surgery Educational Foundation (PSEF) research in     facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi     Nu-Derm System (ODNS) and conventional therapy as treatment adjuncts in ablative facial     resurfacing.   "
248851|NCT01113619|"     This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion     and tolerance.   "
248852|NCT01113632|"     The risk of immunosuppression deters many patients from receiving fludarabine, while     combination chemotherapy regimens are poorly tolerated by elderly or infirm chronic     lymphocytic leukemia (CLL) patients. Previous studies by our group and others have shown that     rituximab is safe and well tolerated when used as a single agent in patients with CLL. In     addition, maintenance therapy with rituximab was well tolerated by CLL patients, with     probable prolongation of progression-free survival (Hainsworth et al. 2003). Based on pre     clinical and clinical studies indicating possible increased efficacy of ofatumumab in     patients with CLL, we wish to develop an antibody-only regimen for older patients and     patients who refuse fludarabine-based regimens.   "
248853|NCT01113645|"     The purpose of this study is to examine the impact of cranioplasty on cerebral hemodynamic     and blood flow as prognostic factor in patients receiving decompressive craniectomy for Head     injuries, Subarachnoid haemorrhage, intra-cerebral haemorrhage, cerebral dural sinus     thrombosis, malignant middle cerebral artery stroke.   "
248854|NCT01113658|"     The purpose of this study is to assess the efficacy of design improvements of the Spiracur     SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current     and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in     order to optimize safety, efficacy, and system performance.   "
248855|NCT01113671|"     This is a biomarker exploratory study which is designed to investigate the function and     oxidation of the high density lipoprotein (HDL) (the good cholesterol) in patients with type     2 diabetes mellitus treated with Vitamin E versus placebo and segregated by the type of the     Haptoglobin protein they have in their blood.   "
248856|NCT01113684|"     Deep brain stimulation (DBS) improves debilitating symptoms of movement disorders when     conventional medical therapies and novel surgical therapies fail. Despite the remarkable     efficacy of DBS, its therapeutic mechanism remains unclear. There is controversy regarding     whether the therapeutic effects of DBS are associated with inhibition or excitation of target     neurons, the introduction of new activity into the network, or a combination of these     mechanisms. Additionally, it is unclear why stimulus frequency plays an important role in the     clinical response to therapy. The fundamental hypothesis of this proposal is that unilateral     subthalamic nucleus (STN) DBS in PD alters neuronal activity in the bilateral basal     ganglia-thalamic-cortical motor system in a manner that is dependent on stimulation     frequency.   "
248857|NCT01113697|"     The investigators are investigating the early and late responses to allergen challenge. The     research participants who the investigators will study (from three cohorts) will be part of     independently-approved studies involving allergen challenge. Due to the uniqueness of the     cohorts for novel genetic study, it is logical that the investigators should initially     undertake hypothesis-generating experiments. The investigators will obtain blood samples from     the participants, both pre-challenge and post-challenge. The investigators will determine     gene expression and protein differences between these samples, and investigate if there are     inherited genetic differences between individuals that may predict their specific responses     to allergens.   "
248858|NCT01113710|"     This non-interventional observational study is designed to gain data for Neupro® in restless     legs syndrome (RLS) under real life conditions in line with the summary of product     characteristics (SmPC) related to effectiveness, tolerability and switching practice from     other dopaminergic drugs as well as titration schemes.   "
248860|NCT01113736|"     The objective of this study is to investigate whether the use of Human Peritoneal Membrane     (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for     purposes of this study, as a decrease in adhesions resulting in decreased operative time     during ileostomy closure, with promotion of peritoneal remodeling.   "
248861|NCT01113749|"     This study is a randomized trial to test whether a decision aid can help to improve the     quality of decision making about feeding options in care of patients with dementia.   "
248862|NCT01113762|"     Younger hip patients often need revision of their hip replacement due to wear and loosening.     Newer concepts (resurfacing and large head total hip replacement) with articulation surfaces     in metal may reduce the wear, increase the longevity of the implant and give an improved     function. The possible downside is that these concepts releases metal debris to the body. The     investigators wish to see if the newer interventions are a clinical improvement compared to     standard. The investigators also wish to investigate the extent of metal released to the body     and any effect on the immune system. Finally the investigators wish to investigate the     stability of these new implants and their ability to preserve the bone around the implant.      The investigators hypothesis is:      That the metal on metal articulations will not have better clinical outcomes than standard     The resurfacing implant is expected to preserve the bone of the upper femoral bone. The     implants are expected to be stabile within the first year.   "
248863|NCT01113775|"     This is a prospective, observational, multicenter study. The primary aim of the study is to     assess the accuracy of spiral CT scan to detect right ventricular dysfunction as compared to     current 'gold standard'in patients with pulmonary embolism. At the purpose of this study     right ventricular dysfunction as assessed by transthoracic echocardiography and serum levels     of troponin are considered as gold standard.      The secondary aim of the study is to assess the prognostic value of right ventricular     dysfunction as assessed by spiral CT scan.   "
248864|NCT01113788|"     The investigators propose a third hypothesis based on the anatomic observations made in     pathological studies. The investigators hypothesize that the anatomic architecture determines     the functional properties of the TV-IVC isthmus. As a result,      • Muscular bundles are preferential routes of conduction through the TV-IVC isthmus. The     isthmus acts like a series of discreet conduction routes rather than as a sheet of tissue.      The muscular bundles form selective targets for ablation and therefore the entire anatomic     line need not be ablated. This has direct implications for ablation of the isthmus.   "
248865|NCT01113801|"     The purpose of this study is to determine if LY2382770 is safe and effective at protecting     kidney function in participants with kidney disease due to diabetes.   "
248866|NCT01113814|"     This study will evaluate the effectiveness of Acoustic Radiation Force Impulse (ARFI)-     Imaging compared to Transient Elastography (FibroScan) in differentiating liver fibrosis in     patients with chronic hepatitis C. Patients who are scheduled to have a liver biopsy will     also undergo ARFI and FibroScan testing. The liver biopsy will be used as the reference     method. The target sample size is 433.   "
248867|NCT01113827|"     Six weeks of supplementation of an olive extract will:        -  Improve antioxidant status        -  Reduce inflammation        -  Reduce muscle damage        -  Improve exercise performance        -  Improve exercise recovery as compared to a placebo.   "
248868|NCT01113840|"     The purpose of this study is :        -  To determine if aerobic exercise conditioning can improve symptoms, cardiovascular          function and quality of life in elderly patients with congestive heart failure.        -  To describe the baseline clinical characteristics, cardiovascular function and          neurohumoral function in elderly patients with congestive heart failure.        -  To determine the specific cardiovascular and noncardiovascular mechanisms by which          symptoms and quality of life may improve following exercise conditioning in elderly          patients with congestive heart failure.   "
248869|NCT01113853|"     Previous studies have demonstrated that exhaled nitric oxide can be useful to monitor the     efficacy of anti-inflammatory treatment as well as to predict a risk of asthma relapse in     asthmatic patients.      The aim of the present study is to evaluate the time course of exhaled nitric oxide in mild     asthmatic patients, stopping regular treatment with inhaled corticosteroids, if it is     possible, in relationship with symptoms and lung function.   "
248870|NCT01113866|"     Biomarkers representing distinct biological domains including neurohormonal, inflammatory,     metabolic-nutritional, oxidative-nitrosative and myocardial injury, might alone or in     combination provide prognostic information on mortality in heart failure patients with     preserved or impaired systolic function.   "
248871|NCT01113879|"     The purpose of the study is to reveal if individuals who participate in aerobic activity     demonstrate improvement in language abilities than patients who do not participate in aerobic     activity.   "
248872|NCT01113892|"     To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline. The     investigators expect the performance of the grafts to be similar.   "
248873|NCT01113905|"     The investigators aim to test whether beta-endorphin, a substance our bodies make in response     to painful and stressful stimuli, plays a causative role in radiation-induced fatigue that     cancer patients receiving radiation therapy commonly experience. If this is so, the     investigators' hope is to direct efforts at treating radiation-induced fatigue using agents     that block the action of beta-endorphin with the aim of improving quality of life for     patients undergoing radiation therapy   "
248899|NCT01107574|"     This study assesses the benefits of intervention with gabapentin, Osteopathic Manipulative     Medicine or both for improvement of the symptoms of Fibromyalgia. This study also seeks to     determine whether these treatments will decrease the number and severity of tender points,     improve structure, function and the overall pain level of each patient from the baseline of     the study to the end. This study is designed to evaluate whether subjects subjectively     experience an improved quality of life and increased function as a result of these     interventions corresponding to objective improvements.   "
248900|NCT01107587|"     The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals'     liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first     dose of vaccination.   "
248901|NCT01107600|"     The purpose of this study is to evaluate survival and success rates of dental implants placed     with immediate loading protocol in extraction sockets. All patients were monitored for 1 year     after implants placement.   "
248874|NCT01113918|"     Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in reproductive     women. It is estimated that 5 to 10% of women of reproductive age have PCOS. One of the major     diagnostic criteria of PCOS was chronic anovulation which lead to irregular menstruation,     amenorrhea, and infertility; the other diagnostic criteria was hyperandrogenism which lead to     hirsutism, acne and alopecia. Furthermore, PCOS is thought as a metabolic disorder, the     long-term consequence of PCOS were diabetes mellitus and cardiovascular disease, which are     potentially dangerous in women health. Early diagnosis and prevention is very important to     the PCOS patients.      Obesity is the most potential risk of threat to health of populations. There is a major     impact of obesity on the PCOS related disorders. Insulin resistance and distribution of     adipose tissue were thought to be the important risk factors of cardiovascular and metabolic     syndrome. To treat PCOS patients properly,Wan-Fang hospital had established a specific     medical team. We recently published in Fertility and Sterility about the clinical     presentation of androgen excess in Taiwanese women. Hirsutism is much less prevalence (30%)     in Taiwanese PCOS women than that previous reported (65-80%) in theWestern women. It is     important to know that some clinical presentation of PCOS might have ethic variance. Insulin     resistance was reported as another candidate that might have ethic variance.We had reported     about 40% women in PCOS women were obese, it is similar with previous literature reported.     Obesity is a major factor that could be controlled during the treatment of PCOS.Weight     reduction is one of our methods in PCOS treatment. The progressive results for obese PCOS     women would be facing the risks of diabetes and metabolic syndrome.We thought like to     evaluate the benefit of weight reduction program to the prognosis of obese women with PCOS.      Furthermore, it is known that Endothelial progenitor cells (EPC) be an early marker of     cardiovascular disease, we would like to know the role of EPC to predict metabolic syndrome     in women with PCOS. Wan-Fang hospital has a professional team in PCOS treatment and research     which including gynecological endocrinologist, cardiologist, medical endocrinologist,     specialist in weight reduction. This team had been working well for more that 4 years.      We hope we can make a contribution to the study and treatment of PCOS in Taiwan.   "
248875|NCT01113931|"     Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day     for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7     days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary     efficacy endpoint is microbiological cure at Day 28. Safety assessments are adverse events,     changes in vital signs and laboratory test results.   "
248876|NCT01113944|"     We are testing whether various cognitive training procedures can enhance cognition and brain     function   "
248877|NCT01113957|"     The purpose of this study is to determine the objective response rate of ABT-888 when given     in combination with temozolomide versus pegylated liposomal doxorubicin (PLD) alone in     subjects with recurrent high grade serous ovarian cancer.   "
248878|NCT01113970|"     This study is a Phase I/II trial of a novel Indibulin dosing schedule for the treatment of     metastatic breast cancer. Eligible patients will have measurable or non-measurable,     metastatic or unresectable, locally advanced breast cancer and may have received any number     of prior therapies for their disease.      It is expected that the Phase I portion will enroll up to 20 patients and the Phase II     portion will enroll up to 45 patients.   "
248879|NCT01113983|"     A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the     Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery     system, Ascendra2™ transapical delivery system and crimper accessories. The trial includes a     premarket pivotal cohort to evaluate the system performance as well as a post market clinical     follow-up phase involving long term follow-up of all patients to evaluate the safety of     investigational devices up to 5 years.   "
248880|NCT01113996|"     The purpose of the study is to test whether additional protein intake with or without     strength training will help to maintain body composition (fat-free mass) after surgical     treatment of obesity by gastric by pass. The main hypothesis is that additional protein     intake will limit fat-free mass loss during surgery-induced weight loss, and that strength     training will have an additional beneficial effect   "
248881|NCT01114009|"     The purpose of this study is to evaluate the effect of lung recruitment maneuver in patients     with early ALI/ARDS   "
248882|NCT01114022|"     A number of techniques have been recommended for the prevention of ventilator acquired     pneumonia (VAP). These techniques - such as patient positioning, continuous sub-glottic     suction of the secretions, selective decontamination of the digestive tract etc… - aim at     prevent the inhalation of oro-pharyngeal contaminated secretions around the cuff of the     tracheal tube used for connecting the patient to the machine. Their efficacy has been     regularly challenged and they are still unable to suppress totally the occurrence of VAP. The     cuff of the tracheal tube used for long-term MV in the ICU is most often a low pressure high     volume polyvinyl chloride (PVC) cuff in order to adhere to a large surface of the tracheal     wall without inducing ischemic lesions. Recent advances allowed industrial companies to     provide us with 1) polyurethane cuffs and 2) cuffs with a conic shape, both potentially     offering a better tightness against inhalation at least in VITRO and in animal models. The     effect on the reduction of VAP incidence has been suggested by several pilot series. The aim     of the present project is to assess the efficacy of four types of cuffs (PVC with a conic or     a cylinder shape and polyurethane with a conic or a cylinder shape) to prevent tracheal     colonisation. We shall measure both oro-pharyngeal and tracheal colonisation during the hours     and days following intubation. This will be done in 600 ICU patients of four university     affiliated centres from France and Tunisia divided in 64 cluster randomized groups. The     results of this research will confirm (or not) the rationale to perform a larger study     designed specifically to address the impact on VAP.   "
248883|NCT01114035|"     This PHRC is centred on the intestinal epithelial dysplasia ( DEI) or  tufting enteropathy      or TE the clinical and histo-pathological descriptions of which are specified well to the     digestive plan(shot).   "
248884|NCT01114048|"     In this study, the investigators will analyze the long-term outcomes of remission and     survival, and identify those with primary resistant disease as more likely to benefit from     CTD (thalidomide, cyclophosphamide, dexamethasone) and early intensification of Vel-CD     (bortezomib and CD) as induction chemotherapy followed by autologous stem cell     transplantation for the patients with newly diagnosed multiple myeloma.   "
248885|NCT01114061|"     The aim of this study is to test the performance of the InsuPatch device in daily life. The     primary target of the study is to evaluate safety aspect of daily device use. Additional     aspects to be evaluated in the study are: the effect of the device on post prandial glucose     level.   "
248902|NCT01107613|"     This study will enroll patients who present to Emergency Departments (EDs) and have an acute     exacerbation of Chronic Obstructive Pulmonary Disease (COPD) at discharged in 2 Edmonton EDs.     Patients will all be provided with evidence-based discharge (prednisone and an antibiotic)     and will be randomized to receive enhanced education to the primary care provider or standard     care. The investigators' goal is to determine if an opinion leaders' advice will improve     chronic care in these patients.   "
249033|NCT01115946|"     This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2     crossover method.   "
248886|NCT01114074|"     Rationale: Cardiovascular diseases are important causes of morbidity and mortality in the     industrialized world. Clinical studies indicate an important role for the proteins of the     contact activation system (coagulation factor XII (FXII), FXI, prekallikrein and high     molecular weight kininogen (HMWK)) on the risk of cardiovascular disease. There is     substantial evidence from mouse studies that FXII and FXI participate in the formation and     stability of thrombi and in vitro studies showed that collagen is able to activate FXII and     hereby stimulate thrombin formation and potentiate the formation of platelet-fibrin thrombi.     The investigators want to determine the role of the proteins of the contact activation system     in platelet mediated thrombus formation in human blood.      Objective: The investigators will study the effects of the proteins of the contact activation     system on platelet mediated thrombus formation, embolization and degradation on collagen in a     perfusion flow model.      Study design: Blood will be collected from human volunteers via a venipuncture in the     forearm. Each volunteer will donate maximally four times 30 ml of blood over a period of two     days. This blood is used in perfusion flow experiments: blood flows over a coverslip covered     with collagen in a flow chamber. The investigators will vary several conditions such as the     concentration of the proteins and the shear rate. For perfusion flow experiments, the     investigators need fresh whole blood because platelets are viable for four hours. After this     time, new blood is needed.      Study population: For this study the investigators need blood from human volunteers with a     coagulation defect in one of the proteins of the contact activation system, e.g. FXII, FXI,     prekallikrein or HMWK and controls without any coagulation defects.      Main study parameters/endpoints: The investigators main study endpoint is the ex vivo     formation of platelet-mediated thrombi on collagen in a perfusion flow model. The     investigators hypothesize that thrombi formed from blood of patients deficient in FXII or FXI     are less stable than those formed from blood from controls.   "
249549|NCT01122576|"     The objective of this study is to evaluate the efficacy and subject satisfaction with three     different FDA approved lenses for adults over 40 years of age who desire a reduction in     spectacle dependence.   "
248890|NCT01107457|"     The primary purpose for this study is to help answer the following research questions        -  The safety of ixekizumab (LY2439821) and any side effects that might be associated with          it.        -  Whether ixekizumab can help participants with Psoriasis.        -  How much ixekizumab should be given to participants.   "
248891|NCT01107470|"     Age-related variability of the efficacy and tolerability of alternative pituitary suppression     regimens in follicular stimulation for assisted reproduction purposes. A randomised,     prospective, multi-centre clinical trial   "
248892|NCT01107483|"     This study was designed for changes in endotoxaemia, endotoxin-binding factors, sICAM-1     (soluble intracellular adhesion molecule-1), and cytokines during progression of chronic HBV     infection. Patients with chronic HBV infection and healthy control are included. A limulus     assay was used to measure plasma endotoxin level and ELISAs were used to measure the     concentrations of interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-α     (TNFα), sICAM-1, and soluble CD14 (sCD14).   "
248893|NCT01107496|"     This will be a randomized, double-blind, placebo-controlled, parallel group, safety and     tolerability study in adults with ADHD. The target subjects are healthy male or female adults     aged 18 to 64 years, inclusive, with a diagnosis of ADHD. A total of fifty subjects will be     enrolled at approximately 5 sites in the US. Subjects will be randomized (1:1) to one of two     treatment groups, SPN-812V or placebo.   "
248894|NCT01107509|"     This study will gather data on potential biomarkers in the treatment of advanced renal cell     carcinoma (kidney cancer) and investigate their use as indicators of disease response. The     results could eventually enable doctors to match levels of therapy to levels of biomarker on     an individual basis and to increase the chance of disease response in patients. This study     will also test a new paradigm in the treatment approach of advanced kidney cancer by using     the drug everolimus in a neo-adjuvant setting, with the overarching goal of decreasing cancer     recurrence rates and improving patient outcomes and survival.   "
248895|NCT01107522|"     The purpose of this study is to determine the safety, tolerability, and the maximum tolerated     dose/recommended phase II dose of carboxyamidotriazole orotate (CTO) as a single agent in     patients with advanced or metastatic solid tumors; in combination with oral Temodar® in     patients with glioblastoma or other recurrent malignant gliomas; or in combination with oral     Temodar® and radiation therapy in patients with newly diagnosed glioblastoma or other     malignant gliomas.   "
248896|NCT01107535|"     Published data by the Organización panamericana de la Salud shows that Peru's mortality rate     from acute respiratory infections (ARI) in infants less than one year of life is second only     to Haiti (14,150/100,000). Government data reports shows a marked increase of RSV infections     in Peru. Instituto Nacional de Salud (Peru's National Institute of Health) reports between     January 1st to February 26th 2006, 62% of their positive samples corresponded to RSV.     Epidemiological data from Lima-Peru, demonstrates that there is no specific season for RSV     infection although some data suggest an increase in RSV activity during cold months (May to     September; INS data). Clinical studies show that giving five doses of Synagis (palivizumab)     resulted in serum concentrations > 30 ug/mL for >20 weeks. The aim of this post-marketing     observational study is to determine the RSV hospitalization rate in high-risk infants who     received Synagis (palivizumab) through the Social Security Hospitals in the context of     routine clinical practice.   "
248897|NCT01107548|"     In Western Countries, stroke and dementia are the main causes of long-term disability,     dependency, and nursing home admission. Due to demographic trends a continuous increase of     patient numbers can be expected.      There is growing evidence that vascular risk factors which are implicated in the etiology of     stroke also play important etiologic roles in both vascular dementia and Alzheimer disease.     The present project is aimed at the reduction of stroke and dementia by means of a systematic     detection and subsequent treatment of vascular risk factors by the family doctor based on     established guidelines.   "
248898|NCT01107561|"     This educational study will examine two different techniques for training emergency residents     and staff on achieving a surgical airway (called a cricothyroidotomy).   "
248903|NCT01114100|"     The purpose of this study is to determine whether care as usual or intervention (consisting     of sertraline versus placebo), are effective in the treatment of panic disorder and/or     depression driven noncardiac chest pain.   "
249034|NCT01115959|"     This study examines early antiepileptic treatment with valproic acid for acute cerebral     hemorrhage against a placebo group immediately post event to evaluate the outcome of these     patients regarding seizures and neurological outcome.   "
248904|NCT01114113|"     The rapid diarrhea that patients experience who have diarrhea occurring after eating specific     foods may be causing a physiologic gastric dumping syndrome. This means that rather than     the food being kept in the stomach for normal digestion, it rapidly goes into the small     intestine and diarrhea occurs. This study is designed to measure how fast the food empties     from the stomach when a person with this problem consumes a regular diet, compared to a     meal with a triggering substance. Each participant will swallow a radio frequency capsule     that with the different meals that will show how fast the food is traveling through the     intestines in the different situations.   "
248905|NCT01114126|"     The primary objective of the study is to evaluate the safety and tolerability of Neu-P11,     following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching     placebo) given nightly over 2 periods of 5 days to male and female subjects with primary     insomnia. In addition, the study is aimed to determine the pharmacokinetic profile of Neu-P11     after 1 and 5 days of administration and to evaluate the hypnotic effects of Neu-P11 as well     as the effects on mood and memory. The study hypothesis is that Neu-P11 is safe, tolerated     and have significant sleep promoting effects.   "
248906|NCT01114139|"     To evaluate the efficacy and safety of IV ferumoxytol compared with placebo for the treatment     of iron deficiency anemia (IDA).   "
248907|NCT01114152|"     This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending     dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male     and female Japanese subjects   "
248908|NCT01114165|"     The overall objective of this study is to assess the clinical value of the SeptiFast Test as     an adjunct to traditional microbiological, clinical, and other laboratory assessments in     early detection and identification of a potential pathogen and therefore early targeted     antimicrobial management of neutropenic hematological patients with suspected infection or     sepsis.   "
248914|NCT01114243|"     Juvenile idiopathic arthritis (JIA) is a serious autoimmune childhood disease that     encompasses several types of chronic arthritis. It is the most common rheumatic disease in     children and can cause significant short-term and long-term disability, including permanent     joint damage. Management of JIA is based on a combination of pharmacologic interventions,     physical and occupational therapy, and psychosocial support. Intra-articular steroid (IAS)     injection, or injection of steroid medication into an arthritic joint, is a routine     therapeutic procedure in clinical rheumatology. Most pediatric rheumatologists currently     perform injections based on knowledge of anatomy and by feeling for anatomical landmarks, but     results from adult studies on ultrasound (US)-guided technique have suggested a role for     using US in treating and managing JIA. The overall goal of this project is to determine the     feasibility of a multicenter study comparing US-guided IAS injection with the usual technique     of using external anatomic features to improve arthritis symptoms in JIA. The key issues that     this pilot project will determine will be: 1) the ability to use US to successfully image and     detect abnormalities in the joints in children with JIA 2) image the injected medication in     the joint space or its surroundings immediately after the injection 3) determine methods to     measure the clinical response to injection 4) evaluate the feasibility of using saved US     scans to localize injected medication in or around the joints and to determine abnormalities     concerning for arthritis. These results will be used to establish the protocols necessary to     design a multicenter study to determine the effect of US-guided IAS injection in the     treatment of juvenile arthritis. Studies regarding the applicability and feasibility of     musculoskeletal US in an outpatient pediatric rheumatology setting are important in order to     establish the utility of this new technology in guiding diagnosis and therapy in JIA. Results     from this study may have a significant impact on pediatric rheumatology and the way by which     pediatric rheumatologists currently assess signs of arthritis and perform routine therapeutic     procedures.   "
248915|NCT01114256|"     The purpose of this study is to better understand the biology of the body's immune response     to monoclonal antibody therapy for cancer. Your health information will be used to identify     your tissues. The tissue we obtain may be useful for research or education, resulting in new     drugs, therapies or diagnostic procedures.   "
248916|NCT01114269|"     This is a prospective, multi-center cohort study of patients with a history of coronary     artery disease (CAD) and documentation of either a prior myocardial infarction (MI) or mild     to moderate left ventricular dysfunction (LVEF 35-50%). The primary objective of this study     is to determine whether biologic markers and ECGs can be utilized to advance SCD risk     prediction in patients with CHD and LVEF>30-35%. The overarching goal of the study is to     identify a series of markers that alone or in combination specifically predict risk of     arrhythmic death as compared to other causes of mortality among this at risk population of     coronary heart disease (CHD) patients with preserved left ventricular ejection fraction     (LVEF> 30-35%). If biologic or ECG markers are identified that can specifically predict risk     of ventricular arrhythmias, then these markers may serve as relatively inexpensive methods to     identify those at risk. The public health impact of identifying markers could be quite     substantial, leading to more efficient utilization of ICDs and advances in our understanding     of mechanisms underlying SCD.   "
248917|NCT01114282|"     The purpose of this trial is to find out the maximum tolerated dose (MTD) of bortezomib     (VELCADE) in combination with pralatrexate in patients with previously treated multiple     myeloma, AL amyloid and Waldenstroem's macroglobulinemia.   "
248928|NCT01114425|"     The objective are to assess the nature and incidence of drug intolerance observed with a new     antiretroviral triple therapy, Truvada® [0-0-1] + Isentress® 400 mg tablets [1-0-1],     prescribed in a setting of the treatment of individuals with recent exposure to a risk of     transmission of HIV infection and to compare the results with those of previous studies     conducted according to the same methodology, with other combinations of antiretrovirals.   "
248929|NCT01114568|"     The purpose of this study is to examine the rate and extent of absorption of three oral     formulations of ertugliflozin (PF 04971729, MK-8835) administered in lean to obese healthy     volunteers.   "
248930|NCT01114581|"     The purpose of this research study is to explore the mechanism of action of Mucinex, an oral,     over-the-counter, FDA approved expectorant in patients with acute respiratory tract     infections.   "
248918|NCT01114295|"     Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by     upper endoscopy and colonoscopy, the presumed source of bleeding in these patients being the     small intestine. These patients fall under the category of obscure gastrointestinal     bleeding, and frequently require an extensive diagnostic work-up.      Obscure gastrointestinal bleeding (OGIB) refers to bleeding undiagnosed by upper endoscopy     and colonoscopy. In 40-70% of cases of OGIB, a bleeding lesion is localizable to the small     bowel. In OGIB, capsule endoscopy (CE) has a diagnostic yield of 40-80%, and has demonstrated     diagnostic superiority to push enteroscopy, barium studies, angiography, CT angiography, and     routine abdominal CT scan. When CE is non-diagnostic, however, the subsequent diagnostic     algorithm is not well-defined. There is currently no established role for cross-sectional     imaging for this indication. CT enterography (CTE) combines the spatial and temporal     resolution of CT with an orally administered neutral enteric contrast material that permits     detailed visualization of the small bowel. Unlike other imaging modalities such as nuclear     medicine techniques and catheter angiography, CT is less labor-intensive, more readily     available, and provides precise anatomic localization. A novel OGIB-protocol available at     Brigham and Women's Hospital for CTE utilizes a dual-phase, dual energy technique that     obtains images at two time points to better identify active bleeding in the mesentery. We,     the investigators, plan to prospectively study an algorithm that employs CTE and compare to     capsule endoscopy to investigate the effectiveness of both modalities and to evaluate the     potential role of CTE in OGIB.      The goal of our study is to determine observationally the contribution of both CE and the new     protocol for CTE to the evaluation and management of overt obscure GI bleeding and     accordingly revise the clinical algorithm.      We hypothesize that CTE will be as or more effective than CE at identifying culprit lesions     in overt, obscure gastrointestinal bleeding.   "
248919|NCT01114308|"     Probuphine (buprenorphine implant) is an implant placed just below the skin containing     buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will     confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses     treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.   "
248920|NCT01114321|"     Dysfunction of autonomic nervous system is an important non motor feature of Parkinson'     disease (PD). Lewy body formation is widely distributed in hypothalamus and in sympathetic     and parasympathetic systems. Animal studies suggest a link between hypothalamus sensing of     substrates and glucose metabolism. Thus, hypothalamus lesions could lead to change in glucose     metabolism. Recently, we showed that fasting blood glucose level was significantly higher in     PD patients than in control group suggesting that glucose tolerance may be impaired in PD.     Some studies provided evidence for higher diabetes prevalence in PD patients whereas others     showed no difference or a reduced risk of diabetes prevalence in PD patients compared to     healthy subjects.      So, the risk that a PD patient develops a glucose intolerance or a diabetes is not clearly     established and merit to be studied considering the damageable consequences for patient     healthy.      The aim of this prospective study was to determine the risk that a PD patient develop a     glucose intolerance or a diabetes compared to a matched control group, using an oral glucose     tolerance test (OGTT).   "
249260|NCT01118650|"     To demonstrate concordance between the Quotient ADHD System Report and standard DSM-IV based     parent and teacher reported rating/assessment scales, currently the accepted method of     symptom measurement for subjects diagnosed with Attention-Deficit/Hyperactivity Disorder     (ADHD).   "
248921|NCT01114334|"     The purpose of the study is to determine whether motivational interviewing with     guideline-based medical management for depression will significantly improve time to     depression recovery and increase the proportion of subjects in recovery compared to     guideline-based medical management alone over 9 months.   "
248922|NCT01114347|"     Indwelling urinary catheters are a primary site for nosocomial infections. The purpose of     this study is to evaluate the anti-adhesive properties of Cranberry type A pro anthocyanidine     gel capsules in the prevention Escherichia coli infections on indwelling urinary catheters     placed in patients following pelvic surgery. The investigators primary working hypothesis is     that cranberry treatment decreases E. coli colonization on indwelling urinary catheters, thus     preventing nosocomial urinary infections following pelvic surgery.   "
248923|NCT01114360|"     This purpose of this study is to test the effect of oral melatonin supplementation (8 mg per     night for 4 weeks) on nighttime blood pressure in African Americans with a history of     elevated nighttime blood pressure.   "
248924|NCT01114373|"     The purpose of this study is to test the effect of oral melatonin supplementation (24 mg per     night for 4 weeks) on nighttime blood pressure in African Americans with a history of     elevated nighttime blood pressure.   "
248925|NCT01114386|"     Cigarette smoking, the major risk factor for COPD, causes not only airway and lung     inflammation, but also systemic effects. These systemic effects of smoking could     substantially contribute to the development of chronic diseases, other than COPD,     particularly chronic heart failure (CHF). The aim of this project is to assess the frequency     and severity of CHF and COPD in outpatients with history of smoking referred to Hospital     because of dyspnea and/or chronic cough.   "
248926|NCT01114399|"     The aim of this study is to examine the effects of a diet rich in broccoli on cardiovascular     disease risk using biochemical indicators such as blood lipid profiles, most notably     cholesterol; markers of inflammation as well as established physiological measurements such     as Pulse wave velocity (PWV), Augmentation index (AIx) and Ambulatory Blood Pressure     Measurements (ABPM). Broccoli contains compounds known as glucosinolates which are     metabolised to isothiocyanates when consumed. The major glucosinolate in broccoli is known as     glucoraphanin which produces the isothiocyanate sulforaphane. The glucosinolates are thought     to be the principal component in broccoli that may reduce CVD risk. The investigators will     use a standard cultivar of broccoli and a cultivar that has enhanced levels of glucosinolates     ('HG broccoli'). This broccoli has been used in previous intervention studies (e.g.     ClinicalTrials.gov NCT00535977). Volunteers will be asked to consume 400g of standard     broccoli, HG broccoli or peas each week over a 12 week period in a double blinded (for the     broccoli) parallel study. The volunteers recruited will, according to the Joint British     Societies (JBS 2) Guidelines on the prevention of cardiovascular disease (CVD) in clinical     practise, have a 10-20% (mild to moderate) risk of developing cardiovascular disease or     having a cardiovascular (CV) event in the next 10 years.   "
248927|NCT01114412|"     A major complication in studies to identify the nature of bladder sensations is language. It     is difficult, if not near impossible, for the lay person, with no knowledge of physiology,     anatomy or pathology, to put into simple terms a description of basic visceral sensations.     Therefore, before the investigators can speculate about the detailed mechanisms generating     sensation the investigators must overcome this language and communication difficulty. This     will be addressed in the present study.      There are important reasons why the investigators must identify the mechanisms generating the     different sensations as the bladder fills. One of them is that these are basic physiological     mechanisms which need to be better understood.   "
248931|NCT01114594|"     The aim of this pilot project is to assess the potential of urine micro-RNAs (miRNA) as     biomarkers for characterizing patients with autosomal dominant polycystic kidney disease     (ADPKD) compared with patients with other causes of chronic kidney disease.   "
248932|NCT01114607|"     This is an open-label, single dose, randomized, five-period, crossover study in healthy     volunteers to assess the relative bioavailability of four GSK developed oral formulations of     GSK1605786 relative to the capsule formulation administered in the ChemoCentryx Phase IIb,     PROTECT-1 Study and ChemoCentryx Thorough QT/QTc Study.      Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the     five formulations of GSK1605786 after a standard breakfast. Serial pharmacokinetic samples     will be collected following each dose and safety assessments will be performed. The relative     bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx     formulation while the relative bioavailability the three other formulations will be compared     to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study.   "
248933|NCT01114620|"     The purpose of this study is to comply with the post marketing condition to the exceptional     approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK     Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.   "
248934|NCT01114633|"     Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in reproductive     women. It is estimated that 5 to 10% of women of reproductive age have PCOS. One of the major     diagnostic criteria of PCOS was chronic anovulation which lead to irregular menstruation,     amenorrhea, and infertility; the other diagnostic criteria was hyperandrogenism which lead to     hirsutism, acne and alopecia. Furthermore, PCOS is thought as a metabolic disorder, the     long-term consequence of PCOS were diabetes mellitus and cardiovascular disease, which are     potentially dangerous in women health. Early diagnosis and prevention is very important to     the PCOS patients.      Obesity is the most potential risk of threat to health of populations. There is a major     impact of obesity on the PCOS related disorders. Insulin resistance and distribution of     adipose tissue were thought to be the important risk factors of cardiovascular and metabolic     syndrome. To treat PCOS patients properly,Wan-Fang hospital had established a specific     medical team. The investigators recently published in Fertility and Sterility about the     clinical presentation of androgen excess in Taiwanese women. Hirsutism is much less     prevalence (30%) in Taiwanese PCOS women than that previous reported (65-80%) in theWestern     women. It is important to know that some clinical presentation of PCOS might have ethic     variance. Insulin resistance was reported as another candidate that might have ethic     variance. The investigators had reported about 40% women in PCOS women were obese, it is     similar with previous literature reported. Obesity is a major factor that could be controlled     during the treatment of PCOS.Weight reduction is one of our methods in PCOS treatment. The     progressive results for obese PCOS women would be facing the risks of diabetes and metabolic     syndrome. The investigators thought like to evaluate the benefit of weight reduction program     to the prognosis of obese women with PCOS.      Furthermore, it is known that Endothelial progenitor cells (EPC) be an early marker of     cardiovascular disease, the investigators would like to know the role of EPC to predict     metabolic syndrome in women with PCOS. Wan-Fang hospital has a professional team in PCOS     treatment and research which including gynecological endocrinologist, cardiologist, medical     endocrinologist, specialist in weight reduction. This team had been working well for more     that 4 years.      The investigators hope that we can make a contribution to the study and treatment of PCOS in     Taiwan.   "
249261|NCT01118663|"     The primary purpose of this study is determine if a new formulation of Acetadote is at least     as effective as the current formulation in the prevention and treatment of acetaminophen     overdose related liver injury.   "
248935|NCT01114646|"     Hemiarthroplasty (half of a hip replacement) is the most common treatment for displaced     fractures of the femoral neck in the elderly and is associated with a better functional     outcome and fewer reoperations than internal fixation. Currently, the operative management of     displaced femoral neck fractures favors the use of cemented implants. This technique is     believed to be more stable in the immediate post-operative period, but there is limited     evidence of a decreased morbidity and mortality with cemented versus press-fit stems     (uncemented). In 2006, a meta-analysis concluded that the evidence was too limited to     recommend a cemented or press-fit hemiarthroplasty.      In this investigation, the morbidity, mortality and functional outcome associated with     cemented and press-fit hemiarthroplasty will be compared prospectively. We propose that the     use of press-fit hemiarthroplasty in the treatment of displaced subcapital fractures of the     femoral neck would be associated with a decreased risk of adverse peri-operative outcomes,     and that the functional results of cemented and press-fit hemiarthroplasty will be equivalent     at one year.   "
248936|NCT01114659|"     Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive     age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic     criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous     as the syndrome. This first part of study is determine whether genetic polymorphisms     influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and     controls. Furthermore, women with PCOS were reported with high risk of cardiovascular     disease, the investigators planned to calculate the difference of carotid intima-media     thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal     control to determine the premature atherosclerosis of women with PCOS.   "
248937|NCT01114672|"     Pruritis (itching) is common in many people with chronic renal failure on hemodialysis. There     may be many different reasons for the pruritis. Efforts to treat the problem have not been     very effective.      Vitamin D levels have been found to be low in many hemodialysis patients. Since vitamin D     plays an important role in the skin and is effective in treatment of certain skin conditions     that involve pruritis, it may have a role in treatment of pruritis in hemodialysis patients.      The objective of the investigators study is to determine the effect of supplementation with     oral vitamin D2 (ergocalciferol) on pruritis in hemodialysis patients.   "
248938|NCT01114685|"     A comparison of changes in bone density following the same bone-health plan, but with a     different bone-health supplement.   "
248939|NCT01114698|"     The purpose of this study is to evaluate the effectiveness and safety of JNJ26489112 compared     with an active control (Venlafaxine XR) and placebo in patients with Treatment-Resistant     Major Depressive Disorder.   "
248940|NCT01114711|"     We are looking for women who suffer from menstrual migraine to participate in a 2-visit     migraine brain imaging research study. Our goal is to see how the menstrual migraine brain's     pain pathways function when the migraineur has been taking Frovatriptan. During the screening     visit (Visit 1) participants will sign the informed consent form, complete questionnaires,     meet with the study physician, and have QST (quantitative sensory testing: to determine your     pain thresholds for a heat stimulus) performed. For Visit 2's MRI scan, subjects will be     asked to lie very still while the scan is occurring. In some parts, they will not have to do     anything, while in others they will be asked to rate pain and unpleasantness for brush and     thermal stimuli. Participants are compensated for both visits.   "
248941|NCT01114724|"     The purpose of this study is to determine if the Valiant stent graft is safe and effective in     treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall     of the aorta, that causes blood to flow between the layers of the aorta and force the layers     apart (dissect). This condition is a medical emergency and can quickly lead to death. Since     stent grafting has been an effective way to treat other aortic conditions such as aneurysms     (bulge in aorta wall), it is believed that the device would be effective in treating     dissections. Information will be collected on the performance of the device for 5 years.   "
248944|NCT01114763|"     Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a     part of Hämeenlinna Metabolic Syndrome Research Program (HMS), 40 men with metabolic syndrome     and their 40 physically active controls (age: 30 to 65 years) are compared in a     cross-sectional study. Except routine laboratory parameters, arterial elasticity and levels     of oxidized LDL are determined.      Study hypothesis: Levels of oxidized LDL and findings in arterial elasticity may differ     between subjects with metabolic syndrome and controls explaining the elevated risk for     cardiovascular diseases among patients with metabolic syndrome.   "
248945|NCT01114776|"     The purpose of this study is to initiate pilot studies to demonstrate that a sufficient     number of iron-overloaded thalassemia, SCD and DBA populations with similar duration of     chronic transfusion, and age at start of transfusions would be available for a confirmatory     study and to validate that proposed multicenter MRI and biochemical studies can be completed.     The study will examine the hypothesis that a chronic inflammatory state in Sickle Cell     Disease (SCD) leads to hepcidin- and cytokine-mediated iron withholding within the RES     (reticuloendothelial system), lower plasma NTBI (non transferrin bound iron) levels, less     distribution of iron to the heart in SCD.   "
248946|NCT01114789|"     The objective of this study is to determine whether obesity has a protective effect on muscle     proteolysis in hemodialysis patients submitted to a short starvation. This effect will be     tested by comparing measuring muscle proteolysis, using regional infusion of a tracer amino     acid (D5 phenylalanine) in two groups of obese and non-obese patients compared to obese and     non-obese control subjects.   "
248947|NCT01114802|"     This study will develop and examine the effectiveness of an intervention that utilizes     multiple telecommunications technologies to improve cancer survivors' access to mental health     care and increase their ability to manage the high risk transition time from active cancer     treatment to survivorship. The intervention, referred to as Project Onward, uses an     interactive website, e-mail, telephone, and an online social network. The purpose of this     study is to pilot a novel intervention that can reduce costs, examine methods to improve     adherence to internet based treatment and overcome numerous barriers to treatment for mental     health concerns.   "
248974|NCT01115153|"     A prospective, randomized controlled clinical trial was conducted at the Hospital     Universitario de Santander to test the effectiveness of providing a single 1-dose therapy of     antibiotic prophylaxis versus a 5-day antibiotic therapy in patients with acute gangrenous     appendicitis.   "
248948|NCT01114815|"     The purpose of this study is to delineate early neurological features and their progression     in patients with cerebral autosomal dominant arteriopathy with subcortical infarcts and     leukoencephalopathy (CADASIL) in order to facilitate early diagnosis, prevent erroneous     diagnosis and mistreatment and improve physician education about this relatively common yet     under-recognized dementing disorder.      Patients with CADASIL suffer from a variant from migraine that differs from wild type     migraine in terms of its severity, progressive nature and underlying pathophysiology.     Recurrent stereotypic acute confusional state associated with the headache episodes in     patients with CADASIL is a distinctive phenomenon, which if recognized will lead to an     earlier and accurate diagnosis of this condition.      Specific Aims:        -  Characterize the nature, frequency and severity of migraine in patients with CADASIL.        -  Delineate the phenomenon of acute confusional migraine as a distinct subgroup of          migraine and establish its prevalence in patients with CADASIL.        -  Determine the latency between the onset of neurological symptoms including migraine, and          diagnosis of CADASIL and the prevalence of misdiagnosis.   "
248949|NCT01114828|"     OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to     cirrhosis patients with ascites despite having received treatment with conventional diuretics     and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.   "
248950|NCT01114841|"     This study will assess the potential of tazarotene foam to cause sensitization during a 48     hour challenge following 21 days of exposure on the skin of healthy volunteers.   "
248951|NCT01114854|"     This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate     Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with     epilepsy.   "
248952|NCT01114867|"     Hypothesis: Measurement of fetal penis length by ultrasound may be inaccurate when measured     from the scrotum to the penile tip. we will provide normal values of penile length measured     from the penile tip to the abdominal wall and measuring the corpus cavernosum length.   "
248953|NCT01114880|"     Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese     participants with ankylosing spondylitis (AS) who have had an inadequate response to or who     are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)   "
248954|NCT01114893|"     The purpose of this study is to determine the safety and efficacy of three concentrations of     travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.   "
248955|NCT01114906|"     This study has been conceived in the context of Health Outcomes Research where the outcomes     of health interventions in routine clinical practice constitute the main objective of the     research process. In the case of asthma in Spain, the investigators do not clearly know the     use of resources generated by the patient with asthma, its impact on the effectiveness of the     current approach of asthmatic patients and the overall efficiency of health interventions on     asthmatic patients. This observational, retrospective and multicenter study aims to estimate     the use of health care resources in managing patients with asthma and to determine the     management of the disease in the usual clinical practice in Valencia Autonomous Region. The     data will be obtained at primary care level from the Electronic Health Record SIA+GAIA data     base and at hospital level from allergologists and pneumologists clinical records. The     investigators plan to introduce 289 ambulatory patients followed-up in Primary or Specialized     Care Services, older than 15 years of age, diagnosed of asthma at least one year before the     beginning of the study. The inclusion period will be of 3 months and the retrospective data     of 12 previous months of follow-up will be collected.      The direct and indirect use of resources will be collected in order to estimate the     management and use of health care resources in managing patients with asthma in the     Autonomous region of Valencia as primary endpoint and also to estimate the mean cost of     asthmatic patient healthcare; to determine the global effectiveness and the efficiency of the     actual asthmatic patient healthcare and to model the health budget according to different     objectives of effectiveness for the next five years.   "
248956|NCT01114919|"     The main aim of this study is to compare the impact of a minimal and a full Internet-based     self-help intervention for problem drinkers in the general population.   "
248957|NCT01114932|"     The purpose of this study is to evaluate the relationship between the time needed to raise     the oxygen concentration in patient's blood to 90% and his/or her body mass index. The     prevalence of obesity in our society continues to rise. No studies have shown the time     required for preoxygenation (oxygen given) in relation to body mass index (body weight in     kg/height in meter2).   "
248958|NCT01114945|"     This prospective, randomized study will compare the effectiveness of 4 different airway     intubating devices which are most commonly used.      The four different devices are as follows: McGrath video laryngoscope, GlideScope video     laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.   "
248959|NCT01114958|"     This phase I study proposes the use of systemic thiosulfate rescue to allow supradose     intra-arterial cisplatin delivery to lung tumors. Eligible patients would be those with at     least one lung lesion large enough of characterize angiographically. All patients will first     undergo a CT arteriogram of the target tumor. Patients will then receive 2 treatments on 2     consecutive weeks. The primary endpoint will be toxicity, with secondary endpoint of response     as measured on week 4. This pilot study will also determine how technically feasible it is to     locate the blood supply to these tumors and deliver cisplatin.      If the first 6 patients do well, 6 additional patients will be accrued for a total of 12.   "
248960|NCT01114971|"     This study proposes to investigate the effects of labetalol or esmolol on managing the vital     signs (like blood pressure and heart rate) during surgery, on pain management, and on the     later recovery after surgery.      It will also assess the cost-effectiveness of Labetalol and esmolol for outpatient surgery.   "
248961|NCT01114984|"     The purpose of this study is to better understand and characterize the pain that some     patients experience after undergoing various breast surgeries, including breast biopsy,     lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic breast augmentation, and     breast reduction.   "
248973|NCT01115140|"     A more recent prospective nonrandomized placebo-controlled double-blind clinical study     demonstrated that metformin exerts a slight but significant deleterious effect on serum     homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to     increase the beneficial effect of metformin on the vascular endothelium.   "
248962|NCT01114997|"     The purpose of this prospective, randomized, double-blinded, active-controlled study is:      To assess the effectiveness of systemic administration of lidocaine and esmolol in     combination (vs. either drug alone) will result in improved postoperative outcomes for     patients undergoing abdominal surgery (e.g., less pain and postoperative constipation, nausea     and vomiting, faster return of bowel function, resumption of normal activities of daily     living), leading to a shorten length of hospital stay, maintaining hemodynamic stability     during general anesthesia, when administered as intravenous adjuvants   "
248963|NCT01115010|"     The study aims to determine whether a proprietary, FDA approved stiffening wire improves the     efficiency of colonoscopy (that is, decreases the duration of the procedure) and/or enables     complete visualization of the colon in a greater proportion of cases (than when the procedure     is performed without it) with old, used colonoscopes.      Colonoscopes are designed with a delicate balance between stiffness and flexibility.     Stiffness helps to prevent curling (looping) of the colonoscope in those sections of the     colon that are not fixed to the wall of the abdominal cavity and flexibility enables     successful negotiation of bends or flexures in the colon. As colonoscopes age, they lose     stiffness and this makes it very challenging to advance the colonoscope all the way to the     cecum (the upper end of the colon). Even when the cecum is successfully reached, it may take     an inordinately long time.      In Jamaica, most endoscopists (General Surgeons and Gastroenterologists) use older, pre-owned     colonoscopes imported from the USA, because the average patient and local health insurance     companies cannot bear the level of fees that would enable cost recovery for new equipment.      The stiffening wires (in two grades of stiffness) used in this study are passed through the     biopsy channel of the colonoscope only after its tip has passed the upper end of the     descending colon and entered the transverse colon. The device is safe when used as     recommended by the manufacturers (and approved by the FDA), and does not appear to increase     risk over and above the risk of colonoscopy with the unassisted colonoscope. Although the     device clearly improves the stiffness of the colonoscope, there is no research evidence that     it actually works in practice, either to improve cecal intubation rate or to decrease     procedure time. It is therefore also unclear whether the possible benefit of using the device     is achieved if introduced at the first opportunity allowed by the manufacturers or only after     difficulty is encountered with the unassisted colonoscope.      In this study, patients are randomly assigned to one of 3 interventions. One group has     colonoscopy performed with the colonoscope alone and the wires are only introduced if there     is difficulty advancing the colonoscope after it has passed into the transverse colon     (difficulty defined as failure to advance the tip of the colonoscope after 5 minutes). In     the 2nd and 3rd groups, the assigned wire will be introduced as soon as the colonoscope     enters the transverse colon and is removed if difficulty is encountered, as defined above.     The different phases of colonoscopy will be timed with a stop watch and when a sufficient     number of patients has been accrued, the investigator will be able to compare the time it     takes to complete the procedure with and without the wires as well as the proportion of cases     in which the cecum was reached with and without the assistance of the wires.   "
248964|NCT01115023|"     Iron deficiency is a common problem in the world and more so in the developing countries with     a prevalence of 64 % (using WHO cut-off values of Hb <11.0 g/dl) among children, 9-36 months     of age. The Pediatric population is especially vulnerable to iron deficiency anemia due to     low intake of iron rich foods, rapid growth with high demand and losses of iron from body     especially with the commonly found worm infestations in children. Mild to moderate iron     deficiency is widely prevalent in children and can have several implications including     failure to thrive, poor scholastic performance, repeated infections etc. Dietary measures     along with therapeutic measures are recommended to combat Iron Deficiency Anemia (IDA).     However, iron rich foods alone cannot be relied upon as a sole step to counter IDA. The     utensil in which the food is cooked plays a major role in determining the final iron content     of food. Several studies have documented that most of the foods (90%) contained significantly     more iron when cooked in iron utensils depending on the acidity, moisture content, and     cooking time of food.The daily dietary intake could vary from 11 to 6 mg of iron if iron     utensil was used for cooking [3].      Food cooked in Aluminum (Al) utensils has a higher Al content which can be detrimental to     healthy individuals and particularly to patients with chronic renal failure.In healthy     persons, diseases of central nervous system, as well as of hematopoeitic system, skeletal     system and respiratory system are described due to excess of Aluminium consumption. Aluminium     utensils have fast replaced iron cooking pots from Indian kitchens, hence a study to know the     effectiveness of iron cooking pot as a measure to combat IDA is necessary.      Studies have shown the utility of cooking food in iron utensil in prevention of IDA but the     investigators did not come across a study to document the use of this modality in treatment     of IDA in children. Since the investigators anticipate that the improvement of iron status     will be a gradual process, so the investigators decided to evaluate the utility of cooking     food in iron utensils on iron status in children with non-severe IDA (Hb% < cutoff point for     age but > 5 gm %.      To test the following hypothesis use of iron utensils for cooking food will result in     improvement in iron status in Pediatric patients with nonsevere Iron Deficiency Anemia.   "
248965|NCT01115036|"     In the current study, the investigators will evaluate intratumoral pharmacodynamic and     pharmacokinetic data associated with the administration of the HDACI, Panobinostat, among     recurrent GBM patients. In addition, this study will evaluate the safety and tolerability of     this agent, as well as evidence of anti-tumor activity in the patient population.   "
248966|NCT01115049|"     Objectives: The study aimed at assessing the efficacy of a new mouthwash in treating oral     lesions due to removable prostheses.      Methods: The present prospective randomized clinical trial was performed on 44 patients. The     experimentation lasted for 4 weeks and 4 operators participated. The effects of the mouthwash     were evaluated subjectively and objectively, with questionnaires, Visual Analogic Scales and     clinical examinations. The results were statistically analyzed. The following variables were     recorded: presence of mucosal lesions due to incongruous removable prostheses and lasting of     pain after rinsing.   "
249035|NCT01115972|"     This study is to assess the effect of ASP1585 on pharmacokinetics of valsartan in 2x2     crossover method   "
248967|NCT01115062|"     The purpose of this study is to compare the effect of Synera patch versus LMX-4 cream and     placebo on the level of pain, observed distress, difficulty of venipuncture and skin side     effects in children undergoing intravenous blood draw in the emergency setting or the     phlebotomy lab.   "
248968|NCT01115075|"     The purpose of this study is to understand the mechanisms for oscillations of dietary     fat/carbohydrate intake and how fat intake affect insulin resistance and liver fat over     interval of 3 to 4 days.   "
248969|NCT01115088|"     The purpose of this study is to test the effects that three different types of sweeteners     have on food intake, hunger and satiety levels, as well as insulin and glucose measures. The     study of whether food or beverages containing Stevia influence food intake to a greater     extent than food or beverages sweetened with Aspartame or Sucrose. Also, examining whether     taste preference and taste sensitivity influence food intake.   "
248970|NCT01115101|"     The purpose of this study is to investigate adequate pain treatment for patients after     cesarean. In this study oral opioids were compared to intravenous opioids as they are     supposed to provide superior pain control.   "
248971|NCT01115114|"     The purpose of this study is to learn if patients being treated with second generation     antipsychotics and with clinically meaningful elevations/levels in any metabolic syndrome     elements will have better access to medical treatment more quickly if they are randomized to     one of the following conditions: 1) a primary care provider located in the community mental     health center where mental health treatment is provided (IMBED), 2) a medical care manager to     help coordinate treatment with an outside primary care provider (Liaison) or 3) the standard     practice of advising the patient to see a primary care doctor (Treatment as Usual).   "
248972|NCT01115127|"     The purpose of this study is to determine whether myo-inositol and melatonin, or myo-inositol     alone, or melatonin alone, are effective in normalizing irregular bleeding and anovulatory     cycles in pre-menopausal women.   "
248975|NCT01115166|"     In patients undergoing extracorporal circulation during cardiac operation, the hemoglobin is     subjected to large changes. The purpose of this study is to see if it is possible with the     help of volume kinetic techniques to use these variations to measure blood volume and fluid     escape from the intravascular volume.   "
248976|NCT01115179|"     The inflammatory properties of propofol are still under debate. Apolipoprotein A-I (Apo A-I)     is involved in the inflammatory process. This study was designed to determine whether and how     propofol or its solvent modulate Apo A-I and the inflammatory response after surgical stress.     The investigators study hypothesis was that propofol might modify the Apo A-I blood levels,     and thus, modulate the postoperative inflammatory course.   "
248977|NCT01115192|"     The aim of the study is to compare the effectiveness in treatment of chronic blepharitis     either with a phospholipid liposome suspension compared to a conventional therapy     recommendation using diluted baby shampoo.   "
248978|NCT01115205|"     The purpose of the study is to evaluate the impact of an exercise programme organized into     supervised walking groups on metabolic control, functional capacity and overall quantity of     physical activity in subjects with type 2 diabetes.   "
248979|NCT01115218|"     The aim of the study is to investigate whether it is possible to predict the success of     trabeculectomy in patients with glaucoma through the examination of mediators of wound     healing in anterior chamber fluid. The success rate of trabeculectomy with mitomycin C in the     literature is about 75%. This leads on the question why 25% of the patients received     trabeculectomy are not sufficient treated and have not a long-term IOP reduction. Precisely     this question is to be examined by the study.   "
248980|NCT01115231|"     Risk factors for Age-related Macular Degeneration (AMD) involves genetic variations in the     alternative pathway of complement inhibitor factor H. The complement system is part of the     innate and adaptive immune system. Smoking is the only environmental factor known to increase     the risk of Age-related Macular Degeneration (AMD). Using serum samples of Age-related     Macular Degeneration (AMD) patients and controls the investigators will test the hypothesis     that smoking increases Age-related Macular Degeneration (AMD) by increasing complement     activation; and that this is positively correlated with known disease variations in the     complement factor H (CFH) gene.   "
248981|NCT01115244|"     The primary objective of this study is to evaluate the efficacy of dapsone gel, 5% in the     treatment of dermatitis herpetiformis. The primary efficacy end point will be the proportion     of patients achieving success based on mean % reduction from baseline in total lesion counts     at week six. Success for lesion reduction will be defined as statistically greater mean     percent reductions at week six in the dapsone gel-treated extremity compared with the control     extremity of each patient.   "
248982|NCT01115257|"     The purpose of this study is to examine and compare, prospectively, best corrected visual     acuity (BCVA) outcomes and complications of a cohort of patients with Proliferative Diabetic     Retinopathy and Tractional Retinal Detachment not involving macula undergoing pars plana     vitrectomy (PPV) or conventional management (panretinal photocoagulation).   "
248983|NCT01115270|"     The main purpose of this study is to compare two types of treatment of hydrocephalus:     placement of a ventriculoperitoneal (VP) shunt versus an endoscopic third ventriculostomy     (ETV). A second goal of this study will be to understand how the two different types of     procedures, VP shunt versus ETV, affect brain blood flow and pressures. Understanding these     changes is important because the investigators hope is to someday be able to predict who will     better respond to one procedure or another.   "
248984|NCT01115283|"     Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of     vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This     study uses psychophysical measures to study neural plasticity in both adults and children     with amblyopia.   "
248985|NCT01115296|"     Helicobacter pylori colonises an estimated 50% of the world´s population (Taylor & Blaser,     1991; Go, 2002). Despite clear clinical guidelines on the treatment of this infection     (Malfertheiner et al. 2007) there is a drive to find alternative ways to control this     infection in a wider perspective without the complications of induction of antibiotic     resistance in the pathogen.      L. reuteri has been widely studied in clinical trials and has been shown to have probiotic,     health-promoting effects in both adults and children (Connolly 2004; Casas & Dobrogosz,     2000). L. reuteri has been shown in numerous studies to be safe for human consumption and it     has been shown to colonise the human gastrointestinal tract (Wolf et al., 1995, Valeur et     al., 2004).      Studies using supplementation with L. reuteri in both symptomatic and non-symptomatic H.     pylori-infected subjects show a clear reduction of infection load after 4 weeks of use and     this was concomitant with a reduction in symptoms associated with the infection (Imase et al.     2007; Francavilla et al. 2007, unpublished data). Further, dietary supplementation with L.     reuteri during and after the period of H. pylori eradication therapy has also been shown to     reduce the side effects of this therapy without affecting the degree of eradication (Lionetti     et al., 2007). It is also feasible, through the inhibitory action of L. reuteri on H. pylori,     that pre-exposure to L. reuteri may weaken H. pylori and make it more susceptible to     antibiotic attack during eradication.      However, an earlier pilot study was not been able to demonstrate a reduction in gastric     inflammation caused by H. pylori. This pilot study was performed with L. reuteri ATCC 55730     that has since been found to lack anti-inflammatory activity in in vitro screens. Recent     selection of natural, human L. reuteri strains has identified a specific strain with strong     anti-inflammatory properties in vitro (Lin et al, 2007 and submitted 2007). A combination of     this strain, together with the earlier proven L. reuteri strain, is expected to lead to both     a reduction of H. pylori load as well as a reduction in the gastric inflammation related to     the pathogen.   "
248986|NCT01115309|"     This is a prospective, non-randomized, multi-center study to assess safety and long-term     patency of the ostia treated with the XprESS device per the device indication for use (IFU).   "
248987|NCT01115322|"     The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a     phototoxic reaction when exposed to UV and VIS light on skin of healthy volunteers.   "
248988|NCT01115335|"     In this study of neonatal male circumcision (NMC), the investigators will examine     acceptability of among parents, feasibility of training providers and implementing services     in various clinical settings, and the safety of service provision comparing three different     surgical methods: the Gomco; the Plastibell; and the Mogen clamp. This operational study is     being conducted to inform the scale up of neonatal male circumcision in Zambia.   "
249023|NCT01115790|"     The primary purpose of Parts A and B of this study is to evaluate the safety and toxicity of     prexasertib (an inhibitor of checkpoint kinase 1[chk 1]) in participants with advanced or     metastatic cancer (Part A), or squamous cell cancer of the head and neck or squamous cell     cancer of any tumor type (Part B). Part C of the study will evaluate prexasertib in three     different groups of participants; those with squamous cell cancer of the head and neck that     has recurred or spread to other parts of the body, those with squamous non-small cell lung     cancer that has recurred or spread, and those with squamous cell cancer of the anus that is     not curable by existing therapy.   "
248989|NCT01115348|"     Stroke is the most common cause for motor disability in the grown-up population in the     Western world. In Sweden > 80 % are above 65 years of age at onset (1).Areas in the brain,     controlling the movement in the upper extremity (UE) are often damaged at a stroke, which     leads to impaired function. This impairment of the UE often leads to limitations in     activities of daily living and reductions in the level of social activities; therefore,     interventions that will improve function are needed to reduce the consequences for the person     living with stroke. The time course of recovery of the UE is not clear and therefore the     optimal timing of the intervention for the person and its content (ways of intervention)     uncertain.      The investigators have developed objective assessments of motor performance with new     technology (kinematic analysis and virtual reality with haptics). Since having an impaired UE     often results in reduced capacity in daily living and social activities, this might lead to     decreased participation. To complement the traditional focus on body function, there is a     need for assessments of the person's activity level and participation, as well as     self-perceived function.      The results from this study will lay the ground for an intervention study focusing on     improved function in the upper extremity.   "
248990|NCT01115361|"     The purpose of this study is to determine the effectiveness of an intervention, which is     designed to increase contraceptive prevalence among postpartum women attending vaccination     services who desire to either space or limit their pregnancies, thus reducing unmet     contraceptive need in this population.   "
248991|NCT01115374|"     Lymphedema is a frequent sequela of breast cancer treatment, that can develop up to 40% of     patients. Lymphedema is the accumulation of protein-rich fluid (lymph) in the interstitial     spaces of the affected body part due to a blockage or malfunction in the lymph system. It can     appear in the arm, shoulder, breast, or thoracic area. Lymphedema swelling causes discomfort     and sometimes disability. The treatment of lymphedema associated with breast cancer can     include complex decongestive physiotherapy, compression therapy, therapeutic exercises, and     pharmacotherapy.      In this study two treatments will be compared to reduce lymphedema: the manual lymphatic     drainage (standard care) versus the low frequency sound waves.   "
248992|NCT01115387|"     The original study (GARM I) has been conducted for more than 18 years at the University of     Pittsburgh Medical Center (UPMC). GARM II is a nationwide research study about age-related     macular degeneration in the next generation of adults (49 to 65 years old). The purpose of     this study is to identify the hereditary and exposure risk factors that lead to the     development of ARM (Age related maculopathy).      Participants will communicate with the research staff through a protected and confidential     website and use this website to complete a number of questionnaires during the course of the     study (see below). For genetic analyses, the participants will mail in easily self-collected     saliva samples in special containers. Eye photographs and eye health records are sent to the     research center from local sources through the Internet. Individuals are not expected to come     to UCLA in order to participate.      https://jseiclinres.jsei.ucla.edu/garm/      Participants will be expected to answer questionnaires or surveys about medical history,     ocular history and visual symptoms, family history, smoking, dietary supplements and light     exposure.   "
248993|NCT01115400|"     The aim of this study is to evaluate the quality of life in patients with abdominal wall     hernias using a user-friendly survey that is designed specifically for this population of     patients. The investigators would like to use this survey to elucidate how quality of life of     the patient is changed with the presence of an abdominal wall hernia.   "
248994|NCT01115413|"     The purpose of this study is to estimate the effect of maternal teenage on pregnancy and     perinatal outcomes among Caucasian pregnant women.   "
248995|NCT01115426|"     This study evaluates prospectively the effects of an anti-angiotensin II regimen on renal     outcome in patients with mesangioproliferative glomerulonephritis followed-up for 10 years.   "
249036|NCT01115985|"     This study is to assess the effect of ASP1585 on pharmacokinetics of atorvastatin in 2x2     crossover method.   "
249089|NCT01116674|"     The objective in this project is to assemble a consortium of pediatric critical care centers     of varying size, acuity, and composition to evaluate our glycemic control protocol on at     least 250 children with hyperglycemia in different critical care units.      ***This Study is supported by an R21 Grant (MRR) from the National Institute of Diabetes and     Digestive and Kidney Diseases (NIDDK).   "
248996|NCT01115439|"     In Afghanistan, studies over the past 15 years have shown a high degree of Plasmodium     falciparum resistance to chloroquine (80%) and more recently an increasing degree of     resistance to sulfadoxine-pyrimethamine monotherapy (12%). In 2003 the high failure rate of     chloroquine against falciparum malaria led the national malaria treatment programme to switch     its recommended first line drug treatment for uncomplicated Plasmodium falciparum malaria to     artemisinin-based combination therapy (ACT) in the form of     Artesunate/Sulfadoxine-Pyrimethamine (AS+SP). Second line drug treatment is oral quinine (7     days). The aim of this study is to conduct ongoing monitoring of the efficacy of the new     combination against P. falciparum in a group of sentinel sites in Afghanistan.   "
248997|NCT01115452|"     An exploratory study investigating the direct application of potassium nitrate (KNO3)     solutions of different concentrations in reducing dentine hypersensitivity.   "
248998|NCT01115465|"     The ROSE Registry will determine the long-term safety and effectiveness of Macroplastique in     the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter     deficiency (ISD).   "
248999|NCT01115478|"     The purpose of this study is to determine the efficacy of zinc and/or vitamin A     supplementation in reducing the risk of placental malaria and its associated adverse     pregnancy outcomes.   "
249000|NCT01115491|"     This is a Phase II, national, multicenter, open-label, non-comparative study to investigate     the efficacy and safety of bevacizumab and temozolomide in patients with recurrent     glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive     bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent     withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.   "
249001|NCT01115504|"     The study is performed to consider the effect of thiamine supplementation on symptoms and     signs of patients with heart failure and systolic and diastolic function of left ventricle.   "
249024|NCT01115803|"     Study JGCB is a multicenter, nonrandomized, open-label, dose-escalation Phase 1b study of     LY2584702 in combination with either erlotinib or everolimus.   "
249002|NCT01115517|"     This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an     adjunctive medication during pterygium surgery in preventing pterygium recurrence. A     pterygium is a white fleshy growth on the surface of the eye, which can be removed     surgically. However, after surgical removal, pterygia can recur. One way of minimizing     recurrence is by applying a medication called mitomycin C to the surface of the eye during     pterygium surgery. However, mitomycin is associated with certain side effects, such as     thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of     action and there is some evidence that it may be useful in preventing pterygium recurrence.     In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and     mitomycin C for preventing pterygium recurrence will be directly compared.   "
249003|NCT01115530|"     In this study we will evaluate whether the addition of a formal lower extremity resistance     exercise training program and/or a nutritional supplement will improve the functional     recovery of older adult veterans participating in a geriatric rehabilitation program for     deconditioning. Specifically, subjects admitted to a geriatric inpatient rehabilitation     program with a diagnosis of deconditioning will be randomly assigned to one of four groups;     1) Control/standard rehabilitation program, 2) Standard rehabilitation plus resistance     exercise twice per week, 3) Standard rehabilitation plus a daily nutritional supplement, 4)     Standard rehabilitation plus the resistance exercise and the nutritional supplement. Subjects     will participate in each program for 12 weeks. At the beginning and end of the study we will     measure lower extremity strength, walking speed, and overall function (using the standardized     Functional Independence Measure), and compare the changes in each group.   "
249004|NCT01115543|"     This study was performed to determine whether calcitriol provides a therapeutic advantage to     alfacalcidol for treatment of secondary hyperparathyroidism in ESRD patients.   "
249005|NCT01115556|"     This is a single-masked study to compare intravitreally administered 0.5 mg ranibizumab to     2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than     30 days following treatment with intravitreal anti-VEGF therapy. Patients will be masked to     their treatment assignment.      The study duration is anticipated to be 12 months and will enroll 30 subjects . Patients will     be randomized 2:1 to either 2.0 mg ranibizumab or 0.5mg ranibizumab.   "
249006|NCT01115569|"     This Phase 3, multi-center study will evaluate the long-term safety and tolerability of     hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in     subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will     be evaluated.   "
249007|NCT01115582|"     This is a study in a small population of children who have inborn errors of bile acid     synthesis who are currently taking established doses of the currently used cholic acid     capsules prepared at the Cincinnati Children's Hospital Pharmacy. The study is designed to     compare the efficacy of these currently used capsules with the efficacy of the same treatment     provided in a cholic acid capsule that is made by a company that will be marketed after FDA     approval.      At baseline, patients receive established doses of cholic acid capsules prepared at the     Cincinnati Children's Hospital Medical Center Pharmacy. During the study, patients receive     the same treatment provided in the to-be-marketed (TBM) cholic acid capsule. Hence, patients     serve as their own controls, with baseline values presenting the reference value (CCHMC     cholic acid capsule) and values after 30 days treatment presenting the value for the     investigational treatment (TBM cholic acid capsule).   "
249008|NCT01115595|"     The purpose of this study is to study the efficacy of allergen injection immunotherapy for     allergic rhinitis by        -  symptoms score        -  medication score        -  quality of life        -  immunologic test from blood   "
249050|NCT01116167|"     Polycystic ovary syndrome (PCOS) is a heterogeneous disorder affecting almost4%-7% of the     female population of reproductive age. Its heterogeneity is characterized by a wide spectrum     of features, including ovulatory dysfunction and infertility, hyperandrogenism,     hyperinsulinemia, insulin resistance (IR), and progression to type 2 diabetes.Since the Ming     Dynasty in China,PCOS has been defined as phlegm and wetnessinfertility in traditional     Chinese medicine ,namely metabolic infertility.Chinese herbs have been used to treat PCOS     for thousands of years with good effects.Berberine has also been used for diabetic patients     in traditional Chinese medicine for hundreds of years. Recent studies have reported its     effects on hyperglycemia and dyslipidemia.The purpose of this study is to determine whether     Letrozole combined with berberine are effective in the treatment of infertile PCOS patients.   "
249009|NCT01115608|"     It is well known that secondary prevention is very important for patients with established     coronary heart disease, it reduces both mortality and morbidity. Pharmacists in Norway are     not routinely involved in follow-up of this patient group, but many studies have shown that     involvement of a pharmacist have a positive influence in achieving therapy goals for e.g.     blood pressure, lipids and blood sugar.      The investigators hypothesis is that follow-up by a clinical pharmacist after hospital     discharge will increase adherence to clinical guideline recommendations and increase     achievement of specific therapy goals for blood pressure, lipids and glucose in patients with     established CHD. The investigators plan to include patients with established CHD, discharged     from hospital after admission to the cardiology department.      Patients included (18-80 years) will be randomized to an intervention and a control group. In     addition to ordinary health care, the intervention group receives follow-up from a clinical     pharmacist during one year with three meeting points, at discharge, after three months and     after one year. The control group receives only ordinary health care, but are called in after     one year for data collection. Patients living in nursing homes, patients already receiving     pharmaceutical follow-up elsewhere and cancer patients are excluded from the study. Only     patients living in the area of Tromsoe and nearby is included, as they need to physically see     the pharmacist.      The follow-up include medication review and subsequently solving of drug related problems in     addition to drug information and monitoring of clinical therapy goals relevant for secondary     prevention of CHD.      The main outcome measures is adherence to specified review criteria defined in a medication     assessment tool (MAT-CHDsp) based on recommendations from the European Society of Cardiology.     Other outcome measures include 1)number of drug related problems identified and solved, 2)     hospital admissions, 3)deaths.   "
249010|NCT01115621|"     The major goals of this project are to determine whether primary intervention through delayed     introduction of dietary gluten is feasible and could reduce the incidence of islet     autoimmunity in high-risk first degree relatives of patients with type 1 diabetes.   "
249113|NCT01116986|"     The goal of this research is to identify the best smoking cessation intervention components     to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This     research examines the ability of different interventions, provided both prior to and after     the quit attempt, to maximize the ability to initially quit and then stay quit. The     investigators will be examining six different treatment interventions: pre-quit nicotine     patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit     phone counseling and duration of post-quit nicotine replacement therapy.   "
249011|NCT01115634|"     Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct     sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good     and radiant skin. However despite all the care taken passage of time will bring about     conditions that will automatically lead to skin aging, which may require certain therapeutic,     care. Fibroblasts are cells that synthesize the extracellular matrix and collagen and play a     critical role in wound healing and maintenance of healthy skin. Loosing of fibroblast cell is     the main problem in aging and wrinkles and non-healed skin wounds. Therefore proliferation of     skin fibroblast along with differentiation of stem cells in the skin tissue is the best     method for healing.   "
249012|NCT01115647|"     Child malnutrition is intimately associated to poverty and may be due to sub-optimal feeding     behaviours, food insecurity at household level, or a combination of both. Acute malnutrition     is a major contributor to under-5 mortality and morbidity in developing countries. While     clinical guidelines for severe acute malnutrition (SAM) have been available for a decade,     research on the management of moderate acute malnutrition (MAM) has lagged behind.     Nonetheless, MAM is much more incident than SAM, it increases mortality risk by itself and     requires special nutritional treatment. This study is thus meant to address this major gap,     by testing the relative feasibility, effectiveness and cost-effectiveness of three innovative     strategies for treating children with MAM aged 6-24 months : a locally produced Ready-to-Use     Therapeutic Food (RUTF), a corn/soy blended flour (CSB++)provided by the World Food Program,     and a specific and context-appropriate child-centred counselling.      The evaluation will be carried out as a cluster-randomized trial in the Houndé district,     Burkina Faso, where 18 rural health centres will be randomly allocated to RUSF or CSB or CCC     for treating MAM.   "
249013|NCT01115660|"     The objectives of the trial of a medication-coach program for patients with stroke or     transient ischemic attack are to pilot test the study design, the intervention components and     the data collection forms and refine them for a larger trial whose goal will be to improve     long-term adherence to stroke prevention medications.   "
249014|NCT01115673|"     The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg     and acetaminophen 1000 mg in dental surgery.   "
249015|NCT01115686|"     The initial hypothesis is that branched-chain aminoacids (BCAA) administration could be     beneficial to patients suffering from sleep apnea syndrome (SAS), the aim of the present work     is to verify this hypothesis.      The literature data demonstrate that a BCAA complementation improves the physical     performances, protects lean mass and increases VO2 max during training.      We demonstrated earlier that this complementation can cure at less partly the hypoxemia of     chronic obstructive pulmonary patients by a stimulation of respiratory centres.   "
249016|NCT01115699|"     The study will systematically investigate the use of repetitive transcranial magnetic     stimulation (rTMS) in non-remitters of a selective serotonin reuptake inhibitor (SSRI)     followed by a serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to     identify gene variants that predict rTMS response.   "
249017|NCT01115712|"     The purpose of this study is to evaluate whether 30 mg of pioglitazone administered once     daily for up to 28 days to healthy overweight and obese subjects will lead to a significant     change in insulin sensitivity, measured in the setting of a hyperinsulinemic euglycemic clamp   "
249018|NCT01115725|"     This is a prospective, open-label, non-comparative, multicentric Phase 4 study to evaluate     the ease of use, local tolerance, safety and effectiveness of Gonal-f® (filled-by-mass in a     prefilled pen) in subjects undergoing ovarian hyperstimulation for in vitro fertilization     (IVF) or intracytoplasmic sperm injection (ICSI) with recombinant follicle stimulating     hormone (r-FSH).      Clarification for change of study type:      The study was erroneously registered as an interventional trial on ClinicalTrials.gov between     2010 and 2012. It was shown recently that the study protocol and conduct of the study did not     include any clinical interventions beyond those which are Standard Clinical Practice and the     approved label for Gonal-f®. Furthermore, all other relevant study essential documentations     (e.g. Informed Consent, CRF, etc.) are in line with an observational study design. As per EU     regulations (Article 2(c) of Directive 2001/20/EC), this study is a 'non-interventional     trial'.   "
249019|NCT01115738|"     This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during     percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on     platelet inhibition in patients presenting with acute coronary syndrome (ACS). Platelet     inhibition following a prasugrel LD in clopidogrel pretreated patients' will be determined in     a time-dependent manner for two different prasugrel loading doses (30 mg and 60 mg).     Understanding the effects of this combination on platelet inhibition will provide guidance to     physicians on the use of prasugrel in patients who have already been pretreated with     clopidogrel.   "
249020|NCT01115751|"     Study JWAA is a multicenter, nonrandomized, open-label, dose-escalation Phase 1 study of oral     LY2780301 in patients with advanced solid tumors.   "
249021|NCT01115764|"     Aims: To test the hypothesis that Diastolic dysfunction severity correlates with adverse     clinical outcome in patients with systolic heart failure.   "
249022|NCT01115777|"     In recent years, remarkable advances in medical oncology, surgery, and radiology have allowed     for increasing cure rates for childhood malignancies. This success has led to an emerging     understanding of the kinds of effects that treatments can have on the pediatric population     and how such effects can influence pediatric cancer survivor's functioning and quality of     life. It has become tremendously important to assess the long-term complications due to     therapy in this growing sector of survivors and to tailor our treatments so as to minimize     these late effects.      The Investigators at MGH are committed to improving the delivery of radiotherapy to our     patients and improving the outcome for these patients. MGH has an on-site cyclotron for     proton radiotherapy in order to provide the most advanced care for patients in need. Proton     therapy possesses a clinical advantage over standard photon therapy in that its optimal dose     distribution delivers the bulk of radiation to the tumor site. This method spares the     greatest volume of normal tissue, resulting in decreased short-term and long-term morbidity.      Through open pediatric protocols for patients treated with proton radiotherapy, the     investigators aim to define and report the acute and late effects associated with treatment.      The investigators also treat a number of patients off-protocol with both proton and photon     radiotherapy, and are interested in reporting these patients' QOL outcomes in conjunction     with other clinical data that may be pertinent to the site of tumor treatment. This research     is significant in that it will allow us to delineate the positive and negative effects of     radiation treatment on patients' QOL, highlighting points of success and exposing areas that     are in need of improvement. Such knowledge will be used to improve the experience of     pediatric cancer survivors in the future.      The aims of this study are: 1) to prospectively collect and report the QOL outcomes in     patients treated with radiotherapy and 2) to correlate the QOL data with pertinent clinical     information.   "
249114|NCT01116999|"     The investigators hypothesise that, for novices, light guided tracheal intubation will     improve the time and success rate of this clinical skill compared to standard direct tracheal     intubation.   "
249025|NCT01115842|"     Vitamin D is known to have immune-modulator effects including suppression of proinflammatory     cytokine expression and regulation of immune cell activity. Vitamin D supplementation has     been associated with a reduction in pro-inflammatory cytokines in patients with heart     failure, and vitamin D deficiency has been associated with higher rates of myocardial     infarcts. The levels of pro and anti-inflammatory cytokines also effect the outcome after     acute coronary events.      The proposed interventional study is targeted as a feasibility study targeted at assessing     the role of vitamin D as an anti-inflammatory mediator.      The study is planned as a randomized open label interventional trial. The study will be     conducted of 50 adult patients (25 interventional group, 25 control), all from the internal     ward in Meir medical center. Patients which are admitted after an acute coronary event will     be randomized to the Vitamin D supplementation group or to the control group. the vitamin D     group will receive 4000IU per day of vitamin D for five days. Cytokine levels will be     measured at day 1 and at day 5. follow up will be continued for 6 months      Primary end point:      Levels of immune mediating cytokines (CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10) after a five     day intervention in patients serum.      Secondary endpoints:      Any major cardiovascular event within follow-up period. Any death of any cause during     follow-up period      Expected results:      the investigators expect vitamin D supplementation after a pro-inflammatory state such as an     acute coronary event, combined with conventional therapy, to result in decreased levels of     inflammatory serum bio-markers.   "
249026|NCT01115855|"     A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure     patients with placebo.   "
249027|NCT01115868|"     There is considerable variation in scarring, within and between people, and between different     ethnic groups. Individuals with more pigmented skin are more prone to severe scarring than     those traditionally termed white. Prevascar is being developed by Renovo for use as a     potential treatment for reducing scarring.      Renovo's histological analysis of wounds and scars in human non drug studies demonstrates an     increase in wound and scar width in subjects of African Caribbean ancestry over a 12 month     period.      It is hypothesised that IL-10 may be a potentially beneficial therapy for the reduction of     scarring in Non Caucasians of African-Caribbean ancestry.      This Renovo clinical trial will be carried out primarily to establish the effects of four     doses of Prevascar on 1cm incisional and excisional scars in subjects of African Continental     Group ancestry, as compared to placebo, and to further investigate the safety and tolerance     of intradermally injected Prevascar in wounds.   "
249028|NCT01115881|"     Signal strength is a parameter introduced in analysis software version 4.0.1, of the OCT     stratus, that combines SNR and uniformity of the signal within a scan The scale of signal     strength ranges from 1 to 10, with 1 representing poor image quality and 10 representing     excellent image quality It has been showed that signal strength has a better image quality     discriminating ability than SNR The operation manual recommends a minimum signal strength of     5 for macular thickness measurement There is no consensus on the level of signal strength     above which should be considered to be good quality The inclusion Criteria for acceptable     signal strength varies widely in the literature the purpose of our study is to examine the     relationship between signal strength and macular thickness measured by stratus OCT   "
249029|NCT01115894|"     Problem drinking gay and bisexual men who try to quit drinking are at risk for relapse to     heavy or problematic drinking because their social lives and social outlets are often     strongly associated with alcohol. These men are most receptive to interventions focused on     moderation of drinking rather than abstinence. However moderation-oriented cognitive-behavior     therapy (CBT) and naltrexone (NTX) are both well established treatments for problem drinkers     who wish to moderate, rather than stop, drinking. Research suggests that combining these     treatments may enhance their efficacy.      This study combines moderation-oriented CBT with NTX in the treatment of problem drinking gay     and bisexual men, who do not wish to abstain from alcohol, to evaluate their efficacy alone     and in combination. We also propose to utilize new data collection technology, Interactive     Voice Response, to collect data on daily relations among drinking, sexual behavior and     psychological variables thought to mediate treatment response. Our objectives are to     evaluation the efficacy of 12 weeks of randomly assigned treatment, with 100 mg of NTX or     placebo, combined with brief supportive therapy or modified, behavioral self-control therapy     specifically tailored to gay/bisexual men; to evaluate conditional relationships between     heavy drinking and likelihood of HIV risk behavior; and to evaluate daily associations among     mood, craving, self-efficacy, motivation, and drinking. Assessments will include baseline, 3,     6, & 9 month follow-up. A substudy of the treatment trial will be conducted to collect and     bank samples from blood for research aimed at associating naturally occurring differences in     DNA with patient response to NTX, and with potential mediational mechanisms of action of NTX.     Information gathered on genes or gene products may be used in conjunction with data on     clinical psychological factors obtained as part of the clinical trial to evaluate     relationships among genetic variants, drug effects, and mechanisms of treatment response.     Patients will be asked to give a blood sample at Week 0 of the clinical trial for the purpose     of carrying out genetic research.   "
249037|NCT01115998|"     Self-produced locomotion often is limited in children with cerebral palsy and other     conditions that cause severe motor impairments. As a result, these children may be at risk     for secondary impairments in spatial cognition, communication, social development, and other     domains influenced by independent mobility. To compensate, power mobility has increasingly     been advocated for young children with severe motor impairments. The study hypotheses were:        1. Children with severe disabilities that prevent independent locomotion who learn to use          power mobility devices when they are 14- to 30-months-of-age will have greater          communication, social, and cognitive development over a 12-month period, and will          demonstrate more competent coping skills than children with the same characteristics who          do not use power mobility.        2. Parents of children who use power mobility will view it as a positive influence on their          children's lives, and will perceive their children's development to be more mature than          the parents of children who do not use power mobility will perceive their children's          development.   "
249038|NCT01116011|"     This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This     MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered     AZD7268 after multiple ascending doses.   "
249039|NCT01116024|"     This is a prospective, non-randomized, multi-center study designed to evaluate safety and     effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing     isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic     Valve is an equine pericardial stented bioprosthesis.   "
249040|NCT01116037|"     The purpose of this clinical study is to determine if there is an increased incidence and     rate of aortic regurgitation in younger (</= 70 years of age) patients implanted with the     Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve,     or replacement of a failed prosthesis.   "
249041|NCT01116050|"     Postpartum haemorrhage (PPH) remains the major cause of maternal mortality in France. The     most efficient treatment of severe PPH is sulprostone which is associated with cardiac     complications. The objective of this study was to assess the efficacy and the safety of     intrarectal misoprostol for curative postpartum haemorrhage treatment.      We conducted a multicenter double blind randomized placebo control trial between June 2004     and December 2007, among consenting women with postpartum haemorrhage and failure to oxytocin     treatment.      Our main criteria of judgement was quantification of blood loss and the use of sulprostone     between the two groups using either misoprostol intrarectal tablets (5X200mg ) or placebo in     similar opaque introducer.   "
249042|NCT01116063|"     Pulmonary hypertension is frequently present in COPD and it is generally limited to a mild     increase in mean pulmonary artery pressure. However some COPD patients are characterized by     higher levels of mPAP at rest, fulfilling the definition of moderate or severe PH     disproportionate PH .      In these patients the elevated pulmonary pressures adversely affect the prognosis.At the     present time the evidence for the the use of specific pulmonary vasodilators in the     management of these patients are scarce and cannot be recommended.the aim of this study is to     evaluate the medium term efficacy and safety of the inhaled prostacyclin stable analog,     iloprost in patients with COPD and moderate to severe pulmonary hypertension   "
249043|NCT01116076|"     Decisions about the use of antibiotics for acute respiratory infections are the most     frequently reported reason for consulting a family physician. Although it varies according to     the specific type of acute respiratory infections, the use of antibiotics is estimated to be     63% to 67%, well above the expected prevalence of bacterial infections thus suggesting     overuse of antibiotics. Consequently, there is an urgent need for helping family physicians     and their patients to improve the clinical decision making process regarding the use of     antibiotics for acute respiratory infections. We will evaluate the impact of DECISION +, a     multifaceted intervention program that includes training in shared decision making, reminders     and feedback targeting physicians, and decision support tools targeting patients on the     decision to use antibiotics for acute respiratory infections. Results from this study will     lay the ground for a national strategy targeting the improvement of the clinical decision     making process regarding antibiotic use for acute respiratory infections in primary care. In     turn, this will increase quality of care and patient safety.   "
249044|NCT01116089|"     The purpose of this study is to assess pharmacokinetic and safety comparability of Bramitob®     when administered for inhalation by using PARI eFlow® rapid electronic nebulizer vs PARI LC®     PLUS nebulizer in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa   "
249045|NCT01116102|"     The purpose is to characterize the in-line pressure profiles associated with several infusion     technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded     by recombinant human hyaluronidase (hylenex). The safety and tolerability of     hylenex-augmented SC infusion of Lactated Ringer's solution fluid is also being evaluated.   "
249046|NCT01116115|"     The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant     formula on intestinal parameters in term formula fed infants.   "
249047|NCT01116128|"     Clinically demonstrated efficacy of Melphalan and Prednisone in MM subjects as well as the     confirmed inhibitory effect of dasatinib on several tyrosine kinase receptors and pathways     implicated in the pathophysiology of MM. Additionally, as a SRC inhibitor, dasatinib plays an     important role on bone metabolism through inhibition of osteoclast-mediated bone resorption     in vitro. Dasatinib could, thus, be beneficial on bone density of patients on study, through     blockage of osteolysis and control of bone lesions.   "
249048|NCT01116141|"     The purpose of this study is to determine if CH-4051 is a safe and effective treatment for     rheumatoid arthritis.   "
249049|NCT01116154|"     RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune     system in different ways and stop cancer cells from growing. Giving vorinostat together with     lenalidomide may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when     given together with lenalidomide in treating patients with relapsed or refractory Hodgkin     lymphoma or non-Hodgkin lymphoma.   "
249090|NCT01116687|"     This phase II trial studies how well RO4929097 works in treating patients with metastatic     colorectal cancer. RO4929097 may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
249051|NCT01116180|"     Hypothesis: Treating patients with type 1 diabetes with a certain antihypertensive drug     preserve cerebral function during hypoglycaemia.      Background: Studies have found that certain genetic variations leaves a subject with type 1     diabetes more prone to hypoglycaemia. It it thought to be a decline in cognition during     hypoglycaemia that leaves them at risk of severe hypoglycaemia. The idea is tha when you     suppress the genetic phenotype with a well known antihypertensive drug an improvement in     cognition will occur and this will remove the patients tendency to severe hypoglycaemia.      Methods: The investigators want to explore whether the cerebral function is improved during     hypoglycaemia in subjects with type 1 diabetes and the above mentioned genetic variation when     treated with the antihypertensive drug Candesartan.   "
249052|NCT01116193|"     The study objectives are to evaluate the safety and efficacy of the oral administration of     lenalidomide in combination with dexamethasone in the treatment of adult patients with     refractory or relapsed non-Ph+ B-cell lineage acute lymphoblastic leukemia (ALL).   "
249053|NCT01116206|"     The purpose of this study is to compare the efficacy and safety of prucalopride to placebo     (an inactive substance that is compared with a drug to test whether the drug has a real     effect in a clinical trial) in treatment of participants with chronic (very serious, life     threatening) constipation (decreased number of or difficulty making bowel [the intestine]     movements).   "
249115|NCT01117012|"     The primary objective of the study was to evaluate the safety of long-term VX-770 treatment     in participants with cystic fibrosis (CF). The secondary objective of the study was to     evaluate the efficacy of long-term VX-770 treatment in subjects with CF.   "
249116|NCT01117025|"     The purpose of this study is the comparative evaluation of systolic blood pressure (SBP)     lowering, atrial fibrillation (AF) recurrence and clinical data in patients with     paroxysmal/persistent AF and resistant hypertension, undergoing AF ablation alone or combined     with percutaneous renal denervation.   "
249054|NCT01116219|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is     not yet known whether bevacizumab given together with pemetrexed disodium and cisplatin is     more effective than erlotinib hydrochloride given together with bevacizumab in treating     patients with non-small cell lung cancer.      PURPOSE: This phase II trial is studying giving bevacizumab together with pemetrexed disodium     and cisplatin to see how well it works compared with giving erlotinib hydrochloride together     with bevacizumab in treating patients with stage IV non-small cell lung cancer.   "
249055|NCT01116232|"     This Phase II clinical trial was designed for patients with hematologic malignancies in need     of donor peripheral blood stem cell transplant, and have no HLA matched donor. Therefore It     will test the efficacy of combining sirolimus, tacrolimus, antithymocyte globulin, and     rituximab in preventing graft versus host disease in transplants from HLA Haploidentical and     partially mismatched donors.   "
249056|NCT01116245|"     Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the     result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus     that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus     which causes cervical cancer. The purpose of the study is to test the safety, tolerability     (how the drug makes you feel), immunology (effects on the immune system) and efficacy     (disease curing effects) of a vaccine called Lovaxin C against E7. The vaccine is designed to     cause the immune system to react against the E7 substance in a manner that is intended to     reverse the changes to the cervix and prevent cervical cancer from occurring.   "
249057|NCT01116258|"     The purpose of this study is to determine the safety, tolerability and blood levels of     AZD5847 after daily oral dosing for 14 days.   "
249058|NCT01116271|"     The purpose of this study is to determine whether treatment with Selumetinib (AZD6244)     (Hyd-Sulfate) in combination with Irinotecan as a second treatment in patients with K-ras or     B-raf mutation will prevent tumor progression and prolong progression free survival.   "
249059|NCT01116284|"     The purpose of this study is to determine if laparoscopic plication of a gastrojejunostomy is     an effective surgical option for the Roux-en-Y gastric bypass patient who has regained weight     due to a dilated gastric stoma. There are several reasons postulated to be the cause in     patients who regain their weight after gastric bypass, including poor diet choices, dilation     of the gastric pouch and enlargement of the gastric stoma. We aim to demonstrate that     laparoscopic plication of the enlarge gastrojejunostomy can provide a safe and effective     method to promote increased weight loss in this subset of gastric bypass patients.   "
249060|NCT01116297|"     To perform a pilot study of the S-FLARE imaging system, which uses low levels of safe,     invisible, near-infrared light to measure tissue oxygenation during breast reconstructive     surgery and to compare S-FLARE measurements to the gold standard, FDA-approved, the ViOptix     optical probe.   "
249061|NCT01116310|"     The purpose of this study is to evaluate the efficacy of FITOGYN vs. placebo on the vasomotor     symptomatology associated with menopause, to evaluate the symptoms of anxiety, the metabolic     parameters in menopause and to evaluate the quality of life associated to the vasomotor     symptoms of menopause.   "
249062|NCT01116323|"     Since the report To Err is Human by the Institute of Medicine (IOM) in 1999, attention was     brought to the general public that adverse events in medicine are common and are one of the     leading causes of morbidity and mortality within the United States. The report estimates that     44,000 - 98,000 patients hospitalized in the United States die each year as a result of     medical errors.      In spite of the growing patient safety movement worldwide, health care has not become     measurably safer. Health care is one of the few risk-prone areas in which public demand     limits the use of common-sense safety-enhancing solutions, such as limiting the flow and     choosing the type of incoming patients. The latter is especially true for emergency     departments (EDs) since they deliver an important public service by providing emergency care     24 hours a day, 365 days per year, without discrimination by social or economic status. One     of the key expectations of EDs is the ability to provide immediate access and stabilization     for those patients who have an emergency medical condition. However, emergency department     (ED) crowding is recognized to be a major, international problem that affects patients and     providers. A recent report from the IOM noted that the increasing strain caused by crowding     is creating a deficit in quality of emergency care. Crowding has been associated with reduced     access to emergency medical services, delays in care for cardiac patients, increased patient     mortality, inadequate pain management, increased costs of patient care, and delays in     administration of antibiotic therapy.      Several issues remain concerning ED crowding and it's relation to adverse events. First, the     existing evidence on adverse event occurrence during ED crowding is largely anecdotal and     inconclusive. Secondly, although a few studies showed a relationship between ED crowding and     mortality, neither of these examined the causes of excess mortality. Finally, although a     significant increase in the average length of hospital stay was shown during ED crowding the     reasons for this are open to speculation.      The purpose of this study therefore is to identify six explicit adverse events and mortality     for patients who were admitted through ED and to compare these results in relation to ED     crowding. This will provide us novel insight into the reasons for the hypothesized increased     mortality during ED crowding.   "
249063|NCT01116336|"     The purpose of this study is to test the preventive effects of a combination of drugs:     polyphenon E (PPE) derived from green tea extracts, and erlotinib. Because this combination     of drugs has not been tested in humans before for the prevention of cancer, it is not clear     which dose of each agent will be optimal in combination.      We will test the safety of the combination of PPE and erlotinib and see what effects (good     and/or bad) it has on the patient's premalignant lesion, and find the highest dose of each     agent that can be given in combination without causing severe side effects.   "
249064|NCT01116349|"     The fracture of the humeral diaphysis is a condition that represents 2% of all fractures. The     conservative treatment of diaphyseal fractures of the humerus has long been considered the     only option and the surgical treatment was primarily reserved for displaced fractures with no     contact of bone ends. However, for a few years there has been an upsurge of indications for     the surgical treatment of diaphyseal fractures.      The purpose of this study is to compare the functional outcomes and the quality of life of     surgically treated patients versus those who undergo a conservative treatment.   "
249065|NCT01116362|"     The purpose of this study is to determine which surgical approach is better for clean     transection injury in peripheral nerves in outcomes.   "
249066|NCT01116375|"     To determine whether, in obese children with moderate-severe Obstructive Sleep Apnea who are     prescribed Positive Airway Pressure(PAP) therapy, increased hours of PAP usage per night over     a one-year period is associated with a greater improvement in HOMA-IR   "
249067|NCT01116388|"     Doctors at MassGeneral Hospital for Children (MGHfC) are doing a research study to learn if a     gluten free-dairy free (GFCF) diet is helpful in improving gastrointestinal symptoms     associated with autism.      Hypothesis: The gluten free/casein free diet (GFCF) will result in a higher proportion of     subjects having reduction in gastrointestinal (GI) symptoms associated with autism spectrum     disorders (ASD).      Primary Study Objective:        -  To assess the effect of a GFCF diet on GI symptoms associated with ASD.      Secondary Objectives:        -  To assess if improvements in GI symptoms result in improvements in autistic behavior          when using a GFCF diet in the dietary management of GI symptoms associated with ASD        -  To determine the nutritional impact of a GFCF restrictive diet        -  To assess the role of food allergies in the manifestation of GI symptoms      This is a 14-week study that requires between 5 & 9 office visits. All study related     activities -including physical exams, blood samples and allergy testing - and an amino acid     based supplement drink, are at no cost. Research study visits will take place at MGHfC in     Boston, or at Newton Wellesley Hospital in Newton, or at Lurie Center/LADDERS in Lexington.   "
249068|NCT01116401|"     We plan to enroll 60 healthy, non-pregnant premenopausal women age 18-45 who do not have hot     flashes (in order to have 30 women complete all study procedures) in a trial investigating     the impact of hot flashes developed in response to an injection of a GnRH agonist, leuprolide     (brand name: Lupron) on sleep disruption and mood. This study is designed to mimic the     menopause transition. Based on previous studies, we expect that 2/3 of the women will develop     hot flashes, naturally dividing participants into two groups: + hot flashes and no hot     flashes. We will collect data on sleep disruption and mood changes to compare differences     between the + hot flashes group and the group of women who do not develop hot flashes on     leuprolide.      Specific Aim 1: To determine the effects of hot flashes on sleep using a model of induced hot     flashes in pre-menopausal women.      Hypothesis 1a: Hot flashes worsen objectively measured sleep      Hypothesis 1b: Exposure to hot flashes leads to the perception of poor sleep quality      Specific Aim 2: To identify the relative effects of hot flashes and sleep disruption on mood     using a model of induced hot flashes in premenopausal women.      Hypothesis 2a: Objectively measured sleep disturbance has a greater effect than hot flashes     on mood      Hypothesis 2b: Perception of poor sleep correlates with negative mood      Exploratory Aim: To establish the feasibility of identifying specific genetic polymorphisms     for genes involved in the estrogen pathway and the development of hot flashes.   "
249070|NCT01116427|"     The ACCLAIM study is testing whether the medication abatacept can be of benefit to patients     with relapsing-remitting multiple sclerosis (MS). Although abatacept is an investigational     medication for MS, it is not a new drug. Abatacept has been approved by the FDA to treat     rheumatoid arthritis.   "
249071|NCT01116440|"     The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics     of multiple doses of BGS649 with concurrent daily administration of combined oral     contraception in patients with refractory endometriosis   "
249072|NCT01116453|"     Since there is unsatisfactory effect by currently pharmacologic therapies and preventive     strategies for dysmenorrhea, this study is designed to evaluate the efficacy and quality of     life of acupuncture for patients with dysmenorrhea based on the theory of traditional Chinese     Medicine.   "
249073|NCT01116466|"     The objective of this study is to evaluate the efficacy and safety of surgical procedure     involving ActiGait - implantable drop foot stimulator.   "
249074|NCT01116479|"     This an open two-arm interventional randomised feasibility study in anaemic patients treated     with chemotherapy. Randomisation is performed between two transfusion thresholds: Haemoglobin     < 6.0 mmol/l (9.9 g/dL) versus haemoglobin < 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l     (13.4 g/dL) for males.Primary end-point is quality of life   "
249075|NCT01116492|"     This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy     vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in     SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic     cholecystectomy.   "
249076|NCT01116505|"     The main purpose of this study is to evaluate the natural history of celiac disease in     asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects     of an intervention with a gluten-free diet. The investigators hypothesize that these subjects     may have decreased general health and benefit of the dietary treatment regardless of the     small-bowel mucosal structure.   "
249077|NCT01116518|"     The purpose of the investigators study is to compare the effect of: 1) physiotherapy 2)     arthroscopic acromioplasty and debridement or 3) arthroscopic rotator cuff reconstruction and     acromioplasty in the treatment of degenerative, atraumatic rotator cuff rupture.   "
249078|NCT01116531|"     Tramadol is an opioid analgesic, which is widely used in the treatment of acute and     neuropathic pain. Treatment of neuropathic pain often requires a combination of pain     medications due to the complex nature of neuropathic pain and frequent inadequate response to     drug treatment. Common drugs used concomitantly with tramadol are SNRI antidepressant     duloxetine and anticonvulsants such as pregabalin. Both tramadol and duloxetine have     serotonergic effects and duloxetine has also a potential to inhibit metabolism of tramadol.     The objective of the study is to investigate the pharmacokinetics and pharmacodynamic     interaction of oral tramadol with duloxetine and pregabalin in patients with chronic     neuropathic pain due to postherpetic neuralgia or diabetic polyneuropathy. All subjects will     receive tramadol and duloxetine or tramadol and pregabalin in a randomized double-blind     order. Primary end point is O-desmethyltramadol concentration.   "
249079|NCT01116544|"     The purpose of this study is to determine if individuals who had a stroke more than one year     before entering the study and who remain unable to open their affected hand are better able     to sense and move their affected arm after 10-15 weeks of treatment with a new robotic     therapy device (the AMES device) and EMG biofeedback.   "
249080|NCT01116557|"     The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3     system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation     Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation.   "
249117|NCT01117038|"     The purpose of this study is to determine the change in the blood pressure and pulse rate,     pharmacokinetics and the safety when avanafil is taken with either enalapril or amlodipine.   "
249081|NCT01116570|"     It is now accepted that physical activity is not deleterious in myopathies, including     muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD),     aerobic training has been reported to be associated to physiological and functional positive     effects without alteration in quality of life. The review papers from Van der Kooi et al.     (2005), Cup et al. (2007) and Féasson et al. (2010) suggest that the combination of endurance     and strength training is even more relevant. Only a few controlled and randomized studies     have been conducted on this topic. The impact of such training programs on the skeletal     muscle regenerative capacities has not been yet addressed. Moreover, due to the fact that     training programs are mainly performed on short-term supervised periods, there is a lack of     knowledge regarding long-term effects, patient's autonomy and whether or not regular exercise     practice can be maintained in patient's daily life. Also, only a few experiments have     reported an integrative view of the potential benefits of such programs on functional,     biological and quality of life.   "
249082|NCT01116583|"     The purpose of this trial is to investigate the effect of gabapentin on thoracic epidural     analgesia following thoracotomy, including assessment of both analgesia, pain intensity, pain     quality and whether or not gabapentin prevents the development of chronic pain conditions     following thoracotomy.      The main hypothesis is that gabapentin reduces the proportion of patients who develop a     persistent pain condition following thoracotomy from 50% to 20%.      Furthermore gabapentin is expected to reduce both pain intensity measured on a 11-point     numerical rating scale, usage of epidural infusions of local and/or opioid analgesics,     morbidity, hospital length of stay, consumption of opioid analgesics and analgesia-related     side-effects.      In addition gabapentin is expected to improve postoperative recovery by means of     postoperative lung function, walking ability, health related quality of life and patient     satisfaction   "
249083|NCT01116596|"     Paracetamol is one of the most widely used analgesics in the world especially for chronic     pain in the elderly. The metabolism of paracetamol occurs in the liver and involves the use     of glutamyl-cysteinyl-glycine (Glutathione (GSH)). Medications such as paracetamol, may     reduce the reserves of GSH because it is used for detoxification and elimination. It is well     known that the concentration of GSH decrease after administration of paracetamol in humans     and animals.      Aging is associated with decreased concentration of GSH in cells and tissues. In the elderly,     a decrease of GSH concentration in plasma or red blood cells is associated with decreased     physical and mental health.      We wish here to determine, in subjects aged over 70 years, the blood concentration of     glutathione (GSH) and urinary loss of cysteine in the detoxification of paracetamol, when     taking paracetamol treatment repeated.   "
249084|NCT01116609|"     The purpose of this study is to define the local metabolic effects of epinephrine in the     bilaterally perfused human leg.   "
249085|NCT01116622|"     Primary objective: To determine the Phase II doses and to evaluate the safety of     administering bexarotene (Targretin®) daily in combination with oral erlotinib (Tarceva™) to     patients with advanced aerodigestive tract cancers.      Secondary objectives: To evaluate the response rates, progression-free survival and overall     survival of patients with advanced aerodigestive tract cancers treated with bexarotene     (Targretin®) in combination with erlotinib (Tarceva™). To investigate the activity of this     targeted combination therapy by evaluating changes in molecular markers from pre- and     post-treatment buccal swab samples.   "
249086|NCT01116635|"     The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when     loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The     study will treat patients with surgically resectable liver cancers with varying doses of     doxorubicin loaded into microspheres, with a close review of any side effects and     chemotherapy concentrations in the bloodstream. The tumors will be surgically removed after     at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor     destroyed. It is hoped that the study results will determine if this treatment has a role in     controlling tumor growth prior to surgical removal.   "
249087|NCT01116648|"     This partially randomized phase I/II trial studies the side effects and the best dose of     cediranib maleate and olaparib and to see how well they work compared to olaparib alone in     treating patients with ovarian, fallopian tube, peritoneal, or triple-negative breast cancer     that has returned after a period of improvement. Cediranib maleate may help keep cancer cells     from growing by affecting their blood supply. Olaparib may stop cancer cells from growing     abnormally. The combination of cediranib maleate and olaparib may help to keep cancer from     growing.   "
249088|NCT01116661|"     The prodrug, 5-Aminolevulinic acid (ALA), has been shown to lead to intracellular     accumulation of fluorescent porphyrins in high grade malignant gliomas in the brain. On     imaging, this accumulation of fluorescent porphyrins helps delineate tumor borders, resulting     in the surgeon being better able to visualize and thus able to make a complete, or     near-complete resection of the tumor.   "
249091|NCT01116700|"     Dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique     properties as a sedative and anxiolytic with minimal respiratory depression. Neurosurgical     patients frequently come to the operating room on anticonvulsant therapy with a history of     seizures. The investigators clinical experience suggests that these patients are resistant to     the sedative effects of dexmedetomidine. This effect may represent a pharmacokinetic     interaction between the anticonvulsant medications and dexmedetomidine or the higher     dexmedetomidine dose requirement could result from abnormal pharmacodynamics due to the     underlying seizure disorder. The investigators study aims to investigate the pharmacokinetic     and pharmacodynamic differences of dexmedetomidine between patients receiving and not     receiving enzyme-inducing anticonvulsant therapy and to identify a potential mechanism for     these differences.   "
249118|NCT01117051|"     The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks     of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from     opioid induced constipation.   "
249119|NCT01110447|"     The aim of the proposed project is to study the effects of a probiotic preparation (VSL#3®)     for the prevention of recurrence of HE (Hepatic encephalopathy) in patients after the     recovery of an episode of overt HE (secondary prophylaxis)   "
249357|NCT01119924|"     The purpose of this study is to evaluate the Efficacy and Safety of Smilon® in the Depression     Patients with pain. Eligible patients will be randomly assigned to 1 of 2 arms, either     Smilon® or placebo, and will receive the treatment for 8 weeks in this study.   "
249092|NCT01116713|"     Postoperative pain, nausea and vomiting (PONV) are the most common complications after     anesthesia and surgery. Women undergoing mastectomy with axillary dissection are at a     particularly high risk for the development of PONV and an incidence of 60-80% in patients     receiving no antiemetic has been reported. Emetic episodes predispose to aspiration of     gastric contents, wound dehiscence, psychological distress, and delayed recovery and     discharge times. These justify the use of prophylactic antiemetics in women scheduled for     mastectomy. Most of the currently used antiemetics, including antihistamines, butyrophenones     and dopamine receptor antagonists have been reported to cause occasional undesirable adverse     effects, such as excessive sedation, hypotension, dry mouth, dysphoria, hallucinations and     extrapyramidal signs. Antiserotonins (e.g., ondansetron) are available for the prevention and     treatment of PONV in patients undergoing various types of surgery [4]. However, the use of     prophylactic antiemetic therapy with antiserotonins has been criticized for being too     expensive.      Dexamethasone was first reported to be an effective antiemetic regimen in patients receiving     cancer chemotherapy.      The purpose of this study was to evaluate the efficacy of dexamethasone treatment for     reducing pain and PONV as well as analgesic and antiemetic requirements in women undergoing     general anesthesia for mastectomy with axillary lymph node dissection.   "
249093|NCT01116726|"     A program of motivational interviewing plus enhanced community services in prevention of     early childhood caries vs. enhanced community services alone for American Indian mothers and     their children will reduce the childrens' decayed, missing, and filled tooth surfaces measure     over a 3-year period.   "
249094|NCT01116739|"     An intensive intervention of specially trained paraprofessionals, called community oral     health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish     and oral health promotion education, compared to usual care, will reduce decayed, missing,     and filled tooth surface measures at 2 years for children in American Indian Head Start     Programs.   "
249095|NCT01116752|"     The primary goal of this project is to determine whether normalizing hyperglycemia is a safe     approach to improve multisystem organ function in critically ill children requiring intensive     care. The will are conducting the PedETrol (the Pediatric ICUs at Emory-Children's Center     Glycemic Control: The PedETrol Trial) Trial, a 4-year single-center, prospective, randomized     clinical trial to evaluate the outcome benefit, safety and resource utilization impact of     maintaining strict glucose control in children with life-threatening conditions.      ***This study is supported by an Research Project Grant (RO1 grant) (MRR) via the National     Heart, Lung, and Blood Institute (NHLBI).   "
249096|NCT01116765|"     To assess whether an oral stimulation program, before the introduction of oral feeding,     enhances the cardiorespiratory manifestations (episodes of oxygen désaturations, and/or     apnea- bradycardia), and the oral feeding performance, in preterm infants born between 26 to     29 weeks of gestation age.   "
249097|NCT01116778|"     The purpose of this study is to evaluate the efficacy and safety of probiotics eN-Lac®     capsules (Lactobacillus paracasei GMNL-32) for the treatment of children with perennial     allergic rhinitis(PAR).   "
249098|NCT01116791|"     The majority of patients with upper gastrointestinal cancer, such as gastric, biliary, or     pancreatic carcinoma, present with metastatic disease, and have an extremely poor survival,     irrespective the type of treatment modality. The aim of the current monocentric phase II     study is to evaluate in these patients the effectiveness of cytoreductive surgery (CRS) plus     hyperthermic intraoperative peritoneal chemotherapy with cisplatin (HIPC). The study is     designed to have at least 80% power to detect a 40% increase in 1-year overall survival     common to all strata (gastric-biliary-pancreas) after CRS+HIPC. Over an anticipated period of     2 years, 60 patients will undergo CRS + HIPC. Translational research will quantify     perioperative circulating and peritoneal tumour cells, based on real-time RT-PCR for CEA and     EpCAM. Plasma concentration of cytokines will be determined for IL-1β, IL-2, IL-6, IL-8,     IL-10, IL-12p70, IL-13, IFN-γ, and VEGF at several time-points. Systemic immunological     changes will be assessed by flow cytometric quantification of the relative proportions and     absolute numbers of B- and T-lymphocytes, NK cells, effector T cells, HLA-DR+ T cells, and     regulatory T cells. Gene-expression studies will be performed using Affymetrix HG U133 Plus     2.0 arrays on primary and metastatic tissue samples.   "
249099|NCT01116804|"     Present imaging modalities for primary liver cancer (hepatocellular carcinoma or HCC) have     several shortcomings. One important shortcoming is the time delay between successful     treatment and radiological confirmation of this response. Often it takes several months for     anatomical changes to occur and to be appreciated on morphological imaging such as CT or MRI     (shrinkage of tumor, absence of contrast enhancement). Functional imaging by means of     Fluor-18 deoxyglucose or Fluor-18 Choline (positron emitters, PET-scan) might be an early     indicator of response. This early information might help to tailor treatment. For instance,     if no response is induced, an early switch in therapy can be planned.      The present study investigates whether the routine PET-tracer (Fluor-18 deoxyglucose) and the     experimental PET-tracer, Fluor-18 Choline help to predict response if a patient with     inoperable primary liver cancer is treated (radionuclide therapy, biologicals).   "
249100|NCT01116817|"     The aim of this study is to describe and compare the percentage of patients infected by HIV-1     to maintain a complete virology suppression at the CSF (CSF CV 1 copy / mL) in patients with     CV <50 copies / mL and treated with stable antiretroviral therapy for at least 3 years with     LPV / r 400/100 mg twice daily + 2 NRTI.   "
254540|NCT02864108|"     The Human Trisome Project will significantly increase the speed of Down syndrome research and     the understanding of associated medical conditions. Its biobank will provide de-identified     samples to research.   "
249101|NCT01116830|"     This randomized, double-blind, placebo-controlled parallel group study will assess the effect     on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of     RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will     be randomized to receive either RO4917838 (10 milligrams [mg] daily orally) or placebo for 6     weeks, in addition to their stable antipsychotic medication. Anticipated time on study     treatment is 6 weeks.   "
249102|NCT01116843|"     The objective of this study is to assess the biological effects in the primary tumor     following a short, pre-operative course of treatment with PF-00298804 in patients with Oral     Cavity Cancer.   "
249103|NCT01116856|"     At the present time, scientific consensus exists on obesity multifactorial etiopatogenia. As     well, professionals and researchers agree that the treatment must approach several scopes,     such as dietetic, physical activity, pharmacologic and surgical. These two last ones should     not be the first election and must be reserved for those cases of morbid obesities or in case     the previous ones have failed. The combination of diet and exercise is still not sufficiently     studied, in special, the addition of strength training, as we propose in this project, for     which established intervention protocols do not exist, and that could suppose an additional     benefit in the reduction of risk factors.      Therefore, the objectives that we aim in this project are enumerated below:        -  To discover which are the most effective training protocols and to determine what type          of exercise combined with nutrition is more appropriate for obesity intervention          programs.        -  To establish the relationship between markers related with cardiovascular risk          (adopokines and lipid profile) and the different intervention protocols proposed.        -  To describe the influence of nine genetic polymorphisms (selected by their relationship          with the energy expense and the physical yield) on the effect of different training          protocols.        -  To determine how important is body composition (fat mass and muscle mass mainly) in          total daily energy expenditure.        -  To establish rules of nutritional and exercise intervention that can be applied in          public and private training centers. If the proposed objectives are fulfilled, this          would contribute to an improvement in patients health in long term, along with an          enormous saving in public health. Therefore, the purpose of this project is to propose          new lines of intervention in overweight and obese adults that, until now, little have          been investigated. This way, resistance training is proposed in combination with          cardiovascular training and endocrinologic treatment. It fits to emphasize that, as far          as we know, it is the first project of these characteristics, that puts in touch the          public and private sector (hospitals, universities and fitness area), to establish          standardized relations protocols to allow a close pursuit of obese patients.   "
249104|NCT01116869|"     The study is designed to confirm the current indication (below) of the CellSearch®     Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in     China.      The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating     tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+)     in whole blood.      The presence of CTC in the peripheral blood, as detected by the CellSearch® Circulating Tumor     Cell Kit, is associated with decreased progression free survival and decreased overall     survival in patients treated for metastatic breast cancer. This test is to be used as an aid     in the monitoring of patients with metastatic breast cancer. Serial testing for CTC should be     used in conjunction with other clinical methods for monitoring metastatic breast cancer.     Evaluation of CTC at any time during the course of disease allows assessment of patient     prognosis and is predictive of progression free survival and overall survival.   "
249105|NCT01116882|"     The primary objective of the trial is to compare the acute safety and long term outcomes     between hospitals with cardiac surgery on-site (SOS hospitals) and hospitals without cardiac     surgery on-site (non-SOS hospitals) for patients with ischemic heart disease treated with     elective percutaneous coronary intervention (PCI) (stable angina, acute coronary syndrome, or     non-Q wave MI) presenting to non-SOS hospitals.   "
249106|NCT01116895|"     An international, multi-centre, prospective, randomised, double-blind, 4-arm, placebo     controlled, parallel group study with 12 weeks once daily oral treatment in subjects with     psoriasis vulgaris.   "
249107|NCT01116908|"     The purpose of this study is to assess whether children under 2 years and other members of     households in which HIV-positive mothers are providing replacement and complementary feeding     would potentially benefit from the use of a filter designed to eliminate microbial pathogens     from drinking water at the household level.   "
249108|NCT01116921|"     The primary objective of this research is to compare the need for intubation and mechanical     ventilation in the first seven days of life for infants with respiratory distress syndrome     (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a     Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive     surfactant.   "
249109|NCT01116934|"     Papillon-Lefèvre syndrome (PLS) is characterised by aggressively progressive periodontitis     combined with palmo-plantar hyperkeratosis. It is caused by loss of function mutations in     the cathepsin C gene. The hypothesis behind this study is that PLS patients' PMNs produce     more proinflammatory cytokines to compensate for their reduced capacity to neutralize     leukotoxin and to eliminate Aggregatibacter actinomycetemcomitans. Production of more     interleukin (IL)-8 would result in the attraction of more PMNs. Thus, the aim of this study     was to evaluate the cytokine profile in PLS patients' blood cultures.   "
249110|NCT01116947|"     Protein-energy wasting, as reflected by a serum albumin <4.0 g/dL, is very common in     maintenance hemodialysis (MHD) patients and associated with poor clinical outcomes including     high death rates. Hyperphosphatemia, reflected by serum phosphorus level >5.5 mg/dL, is also     common disorder and associated with increased death risk in the same population. The     traditional dietary intervention to control hyperphosphatemia is to restrict protein intake.     This, however, may worsen protein-energy wasting as recently showed in large epidemiologic     data, which indicated that the best survival was observed in MHD patients with increased     protein intake while serum phosphorus could be controlled. We hypothesize that the provision     of high protein diet will be possible if a potent phosphorus binder (Fosreonl™) will be     prescribed simultaneously. Hence, we propose to conduct a randomized controlled trial in 110     hypoalbuminemic (albumin <4.0 mg/dL) MHD patients in several DaVita dialysis facilities in     Los Angeles South Bay area. After 1:1 randomization, we will provide the participating     subjects (the INTERVENTION group) with 8 weeks of high protein meals in form of prepared meal     boxes (50 g protein, 850 Cal, and a phosphorus to protein ratio of <10 mg/gm) during each     hemodialysis treatment, along with 0.5 to 1.5 g Fosrenol, to be titrated if necessary; as     well as dietary counselling to maintain a high dietary protein intake at home (with same or     similar binder regimen) for 8 weeks and to avoid food items with high phosphorus based     additives. Meals will be prepared at Harbor-UCLA GCRC Bio-nutrition Department. We have     reviewed and tested the feasibility of meal preparation and distribution system and the     related logistics. The CONTROL group will also receive meal boxes but the meal contains low     Calorie (<50 Cal) and almost zero protein (<1 g) diet (such as salads) during each     hemodialysis treatment. These patients will continue their pre-existing phosphorus control     regimens. As outcome variables, we will examine change in serum albumin over the 8 weeks of     intervention. We will also examine changes in dietary protein and serum phosphorus in the 2     groups after 8 weeks of intervention. Quality of life and patient satisfaction will also be     examined before and towards the end of the intervention phase. Given our ongoing 2-year study     with a similar operation known as the AIONID Study and given DaVita dieticians''     collaboration and support, we anticipate successful recruitment, retention and data analyses     within 8 to 12 months.   "
249111|NCT01116960|"     The investigators hypothesize that common objections to P4P relate to potential loss of     autonomy or concerns about adverse effects on patient care.   "
249112|NCT01116973|"     The purpose of this study is to compare CVP measurements from CICCs and PICCs. The     investigators will also evaluate whether or not the duration of CICC placement affects the     differences in CVP measurements between the CICCs and PICCs. The investigators hypothesize     that the differences between the CVP measurements of the CICCs and PICCs will be clinically     insignificant.   "
249318|NCT01119404|"     Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a     part of Hämeenlinna Metabolic Syndrome Research Program (HMS) surrogate indicators for     atherosclerosis are studied in 120 men with metabolic syndrome, 120 men with coronary heart     disease and 80 physically active controls and in different settings.   "
249120|NCT01110460|"     Accordingly, the new update of the Global Initiative for Asthma (GINA) guidelines 2006 is     based on the control of the disease and attempts to quantify and graduate the level of     control by using a classification of asthmatic subjects into controlled,partly controlled and     uncontrolled groups.      Achieving and maintaining optimal asthma control is a major goal of asthma management.     Although the results of clinical trials advocate that asthma control can be reached in most     patients, there is evidence that many subjects with asthma have poorly controlled disease and     that there is a significant gap between the treatment goals and the current level of asthma     control achieved in the general population.      The aim of this study is to assess the prevalence of uncontrolled and partly controlled     asthma in Italy using a patient-based tool such as Asthma Control Test.   "
249121|NCT01110473|"     The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated     dose of ABT-348 as monotherapy and when given in combination with azacitidine.   "
249122|NCT01110486|"     The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated     dose of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel.   "
249123|NCT01110499|"     This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of     AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in     the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a     formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost     ophthalmic solution 0.03% for 4 weeks.   "
249124|NCT01110512|"     It is hoped that with the use of medication, occurs improvement of the CVI parameters, such     as edema, pain, night cramps, functional discomfort, heavy feeling and that the drug test is     non-inferior than the comparator.   "
249125|NCT01110525|"     The primary purpose of this study is to determine whether the treatment with AZD1981 will     affect the metabolism of hormones included in oral contraceptives.   "
249126|NCT01110538|"     Information will be collected prospectively in about 3,000 patients having Optical Coherence     Tomography during cardiac catheterization. Subjects will be initially enrolled at sites     outside of the United States, where Optical Coherence Tomography is approved by regulatory     agencies. Subjects will be followed for up to 5 years.   "
249127|NCT01110551|"     The purpose of this study is to test the safety and immune response to a live attenuated     dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated     means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated     (weakened) so as not to cause dengue disease in people. Dengue virus is spread to people by     mosquitoes and can cause sickness and even death. Seventy-two subjects between the ages of     18-45 years old will be enrolled in this research study at Saint Louis University Center for     Vaccine Development. Participants will be randomly assigned to 1 of 4 groups to receive 2     doses of the study vaccine or placebo (inactive substance). Study procedures include:     maintaining a diary to record temperature and side effects, physical exam, electrocardiogram     (ECG) (measures the activity of the heart), and blood samples. Participants will be involved     in study related procedures for about 10 months.   "
249139|NCT01110707|"     This was a prospective, randomised, Phase II, comparative study with a parallel control for     evaluating the efficacy and safety of combined treatment of recombinant human follicle     stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined     treatment was administered at the middle of the follicular phase in subjects undergoing     in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of     embryos (ET).      Few evidences suggest that aged subjects have more possibilities of obtaining a benefit from     the combined use of FSH and LH. This study was designed to find out whether the addition of     r-hLH on the sixth day of stimulation with r-hFSH in conventional protocol improves the     assisted reproduction in terms of quality of recovered oocytes, implantation rates and     pregnancy rates in subjects.   "
249140|NCT01110720|"     The purpose of the study is to evaluate the safety and efficacy of davunetide for the     treatment of Progressive Supranuclear Palsy.   "
249128|NCT01110564|"     The primary objective of this non-interventional study is to evaluate daily symptom     variability in COPD patients. The secondary objectives are; to evaluate effects of COPD     symptoms on the morning activities of patients, to determine therapeutic expectations of     patients and physicians in COPD, to determine which and how frequent non-drug approaches are     recommended in order to prevent COPD exacerbations, to define COPD patient profiles about the     below-mentioned issues: Demographic characteristics, Disease characteristics, Concomitant     diseases and implemented drug treatments. All patients, who apply to the study physicians and     fulfill all patient selection criteria during patient enrolment period, will be included.     Patients, who provide all of the following measures will be included in the study: To apply     to a physician for outpatient treatment for any reason, Age over 45 years, being diagnosed     with COPD, being a smoker or used to be a smoker once (> 10 package years), to give consent     for the use of their medical data. The patients that exhibit the following exclusion criteria     will be excluded from the study: COPD exacerbations still on-going or experienced in the last     3 months (Exacerbation is defined as worsening of COPD symptoms leading to antibiotic and/or     short-term oral steroid treatment and/or hospitalization or admission to the emergency     unit.); Presence of lung cancer or an important respiratory disease such as bronchiectasis,     pulmonary fibrosis, interstitial pulmonary disease, tuberculosis, sarcoidosis; Participation     in an interventional clinical trial at present and Enrollment in this study once. In this     study, patients will be recorded at their visit to the physician and there will be no     follow-up thereafter.   "
249129|NCT01110577|"     This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction     measurements using up to two MRI-based methods. The intra-class correlation coefficient (ICC)     for the repeated measurements is expected to be greater than 0.6.   "
249130|NCT01110590|"     Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this     multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552     and vardenafil will be given with patients with erectile dysfunction.   "
249131|NCT01110603|"     This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and     recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard     doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the     treatment of advanced solid cancers in adults.   "
249132|NCT01110616|"     The objective of this study is to test the experimental reproducibility and within-subject     variability of qEEG (quantitative electroencephalogram) using two probe compounds: MK3134 and     lorazepam.      This study will test the hypothesis that EEG (Electroencephalogram) theta power, averaged     across a topographical region of interest is decreased 6 hours after administration of MK3134     compared to placebo.      The objective of this study is to test the experimental reproducibility and within-subject     variability of qEEG using two probe compounds: MK3134 and lorazepam.   "
249133|NCT01110629|"     The objective of this study is to investigate the efficacy and safety of lanthanum carbonate     750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.   "
249134|NCT01110642|"     This is an open label-pilot study to assess the efficacy and safety of a novel     cholesterol-lovastatin topical solution in children with rare syndromic ichthyoses. Often     times, these children have difficulty in finding easily applied treatments to make their     psoriasiform and ichthyotic plaques more manageable. We propose the use of a     cholesterol-lovastatin topical solution as a treatment option with the hypothesis that it     will lead to regression of involved areas and decreased erythema and warty-like appearance of     the plaques. We plan to enroll children with syndromic ichthyoses over the age of 1 year for     a 12 month study with a total of 5 visits and 5 phone calls.   "
249135|NCT01110655|"     The purpose of the study is to 1) evaluate incidence and primary cause of exercise-associated     Hyponatremia (EAH) in race finishers participating in the Western States 100-mile Endurance     Run, 2) determine if the ingestion of oral hypertonic saline (high salt) is as effective as     intravenous administration of hypertonic saline to elevate below-normal blood salt     concentrations (EAH) at the end of the Western States Endurance Run, and 3) determine if oral     and intravenous hypertonic saline solutions are equally as effective at reversing mild     (without altered mental status) symptoms associated with EAH.   "
249136|NCT01110668|"     This study will assess time-to-disease progression in patients with advanced gastrointestinal     stromal tumor (GIST) previously treated with imatinib ≥600 mg.   "
249137|NCT01110681|"     The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in     the treatment of fecal incontinence for a total of 24 months after completed treatment.   "
249138|NCT01110694|"     Idiopathic pulmonary fibrosis (IPF) is a progressive scarring condition of the lungs the     cause of which is unknown.There are currently no effective treatments for IPF and the     condition tends to cause progressive disability and death with an average survival of 3.5     years from diagnosis. The condition is responsible for the deaths of 4000 people per year in     the UK. At present the definite diagnosis of IPF rests on the identification of a specific     pattern of fibrosis when a section of fibrotic lung tissue is examined under a microscope.     Unfortunately, the process of obtaining a lung biopsy requires an operation and is not with     out risk. The investigators hope to identify specific markers in the blood and lungs of     patients with IPF that will enable the condition to be diagnosed without biopsy. Furthermore,     the investigators hope to identify indicators(biomarkers) that will predict which patients     have more aggressive and progressive disease and also to identify biomarkers that might be     useful in identifying a response to treatment and might therefore be used in future clinical     trials in IPF. As well as looking at markers in the blood and lungs the investigators also     plan to assess the use of daily home lung function measurement and a computerised technique     for analyzing lung sounds to see if these are investigations that are able to predict the     development of worsening lung fibrosis.   "
249141|NCT01110733|"     The COMPLETE registry is a prospective, longitudinal, multinational, observational study that     will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated in     academic and community practices. The registry will enroll newly-diagnosed patients with PTCL     treated with a variety of regimens. The COMPLETE registry is designed to better understand     PTCL patient characteristics, treatments, and outcomes to help design and understand future     clinical trials.   "
249144|NCT01110772|"     The purpose if this study is to determine whether a microbial sealant (iodine +     cyanoacrylate) [InteguSEAL®, Kimberly-Clark] reduces surgical site infections when compared     to iodine and isopropyl alcohol (povacrylex in isopropyl alcohol) [Duraprep®] in oncologic     surgery.   "
249145|NCT01110785|"     RATIONALE: Simvastatin may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. Giving simvastatin     together with panitumumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well simvastatin given together with panitumumab     works in treating patients with advanced or metastatic colorectal cancer.   "
249146|NCT01110798|"     RATIONALE: It is not yet known whether a J-pouch colorectal anastomosis is more effective     than a straight colorectal anastomosis in treating patients with rectal cancer who have     undergone surgery to remove the tumor.      PURPOSE: This randomized clinical trial is studying J-pouch colorectal anastomosis to see how     well it works compared with straight colorectal anastomosis in treating patients with rectal     cancer who have undergone surgery to remove the tumor.   "
249147|NCT01110811|"     The study objective is to evaluate the relative merits, safety and effectiveness of transoral     incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients     compared with sham procedure.   "
249148|NCT01110824|"     The investigators' objective is to assess the efficacy of the combined treatment with     enalapril and carvedilol in the prevention of left ventricular systolic dysfunction in     patients with hematological malignancies submitted to intensive chemotherapy with potential     cardiotoxicity.      The hypothesis is that these drugs administered during chemotherapy may prevent left     ventricular systolic dysfunction.   "
249188|NCT01111344|"     The purpose of the study is to assess the efficacy of Glizigen and Viusid administration in     the treatment of external anogenital warts in children and adolescents. The duration of this     double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number     of persons to be recruited and randomized for the study is 76. Variables to be assessed will     be: time to disappearance of lesions, reduction of the number of lesions and change in the     aspect of lesions.   "
249149|NCT01110837|"     What happens in the nose during an allergic reaction? Are there changes that a new drug could     treat? What is the best way to test new drugs?The response of the nose to being exposed to     cat allergen in someone who is allergic to cats. Symptoms, level of nasal blockage and cell     and chemical changes that occur in the nose will be studied before and after being exposed to     cat allergen. The investigators will also to see if giving repeated doses of allergen     increases the response.Allergic rhinitis is a very common illness. There are over 500 million     patients worldwide. It can increase the severity of associated asthma. Currently available     drugs do not completely treat the symptoms. New treatments need to be found. A way of testing     these drugs is very important. This study will investigate causes of the symptoms that occur     in allergic rhinitis. It will also validate a proposed model to test new drugs. the Study     Hypothesis is that a model of nasal allergen challenge shows an increased response (priming)     with repeat challenges as determined by changes in nasal peak inspiratory flow.   "
249150|NCT01110850|"     Chronic lymphocytic leukemia. B-cell chronic lymphocytic leukemia (B-CLL) is the most     prevalent leukemia in the Western Hemisphere, accounting for ~25% of all leukemia's. It     represents a monoclonal expansion of small, long-lived, apparently slowly dividing CD5+ B     cells. Because of the low proliferative index and a presumed uniform proliferative rate of     B-CLL cells in vivo (a fact not yet tested or documented), B-CLL appears to be primarily a     disease of accumulation rather than proliferation.   "
249151|NCT01110863|"     By ingesting a non-radioactive and non-toxic compound heavy water for 6 weeks, the DNA of     newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia can be     labeled and followed by performing routine blood draws at specified time intervals. By using     mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the     bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help     us to better understand the unique characteristics of this disease process.   "
249152|NCT01110876|"     Phase I Objectives:      -To determine the maximum tolerated dose (MTD) of vorinostat + erlotinib versus vorinostat +     erlotinib + temozolomide in adult patients with recurrent glioblastoma multiforme (GBM) and     anaplastic gliomas.      Phase II Objectives:      Primary: To determine the efficacy of vorinostat + erlotinib versus vorinostat + erlotinib +     temozolomide in patients with recurrent glioblastoma multiforme as progression free survival     using a two arm adaptive randomization phase II trial design.      Secondary: To determine the radiological response, progression free survival (PFS) at 6     months, overall survival and unexpected toxicity in the two treatment arms; and to obtain     exploratory data regarding histone 3 and 4 acetylation, treatment related changes in the     epidermal growth factor receptor (EGFR) pathway proteins, and changes in e-cadherin and     vimentin expression (mRNA /protein) levels in tumor tissue and peripheral monocytes in a     subset of surgical patients.   "
249153|NCT01110889|"     The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of     sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive     Disorder. This study includes an 8-week double-blind phase.   "
249154|NCT01110902|"     The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of     sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive     Disorder. This study includes an 8-week double-blind phase.   "
249155|NCT01110915|"     The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in     the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up     to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur     anywhere on the body including the chest).   "
249156|NCT01110928|"     This study is conducted in Japan. The aim of this observational study is to collect     information about the safety and efficacy of Norditropin® in the long-term treatment of     patients with a SGA (small for gestational age) short stature where the growth plate in the     long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial     (NCT00184717).   "
249157|NCT01110941|"     S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal     cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more     encouraging efficacy on colorectal cancer. This study is to explore the feasibility of the     SOL regimen on efficacy and tolerability on Chinese colorectal cancer patients.   "
249158|NCT01110954|"     This is an explorative phase II study to investigate the suitability of PD L 506 in the     specific intra-operative detection of breast tumour tissue.   "
249159|NCT01110967|"     The Satellite™ Retrospective Analysis is an international, retrospective, multi-center,     non-interventional post-marketing study designed to document and analyze existing data with     the device in a real-world setting.      The purpose of this study is to evaluate number of adverse device effects (ADEs), serious     adverse device effects (SADEs) and serious adverse event (SAEs) and early clinical     effectiveness for the Satellite™ Nucleus Replacement in a standard clinical practice. Data     collection will include information on health related quality of life (QoL), physical     functioning and adverse event after nucleus replacement surgery. Radiographic measures will     also be assessed to evaluate changes in disc height at the operated level and changes in     segmental range of motion.      All patients who were implanted with a Satellite™ Nucleus Replacement Prosthesis in the     participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.   "
249173|NCT01111149|"     There is a strong association between smoking and schizophrenia with prevalence rates ranging     from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number     of hypotheses have been proposed to explain the relationship between high smoking rates and     schizophrenia, mostly relating to self-medication primarily for the negative symptoms of     schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower     than for other psychiatric disorders. The negative health effects of smoking increase the     morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl     in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not     been any published studies of the efficacy of varenicline in schizophrenic subjects. As     varenicline appears to be a promising treatment in non-psychiatric patients, it would be     useful to expand these studies to examine its effects in schizophrenic patients. Identifying     effective and safe means of smoking cessation for this vulnerable population has the     potential to reduce morbidity and mortality among individuals with schizophrenia.   "
249160|NCT01110980|"     -  Background:      Oral nutrition appears to be a challenge for patients with head and neck cancer after     radiotherapy. Many patients desire to (their) `normal food intake` and return to oral     nutrition with normal consistency without modifications and diet formulas. Due to the     dysphagia experienced post treatment this seems tremendously difficult. Referral to a     speech-language therapist for swallowing therapy is no standard procedure.        -  Study design:      A prospective randomized study in patients with a tumor in Oral cavity, Nasopharynx,     Oropharynx, Hypopharynx or Larynx with stage II-IV (UICC TNM-tumor classification), ≥ 18     years, eligible for primary treatment with (chemo)radiation or adjuvant radiotherapy with     curative intent.        -  Intervention:      Individually tailored swallowing therapy by an experienced speech-language therapist in     cooperation with individual dietary counselling (by an experienced dietician, `usual care`)     pre-, per- and post treatment (until 6 months after treatment). This might improve `normalcy     of food intake`, quality (no food modifications) and quantity of food intake and besides     decrease the use of tube feeding and/or nutritional supplements. Also patients quality of     life and nutritional status may be influenced positively.        -  Study hypothesis:      The purpose of this study is to determine whether combined individual swallowing therapy and     individual dietary counselling in patients with head and neck cancer receiving     (chemo)radiotherapy can improve 'normal food intake'. Food intake without modifications and     tube feeding and/or nutritional supplements.   "
249161|NCT01110993|"     This is a prospective, non-interventional, multicenter study to evaluate quality of life     (QoL) and influence of cognitive status on QoL in subjects with relapsing-remitting multiple     sclerosis (RRMS) during two years of treatment with Rebif New Formulation (RNF).   "
249162|NCT01111006|"     The purpose of this study was to evaluate the effect of Bidet on anal resting pressure with     regards to various flow rates and temperatures.   "
249163|NCT01111019|"     This study is conducted to describe the efficacy and safety of recombinant human growth     hormone (r-hGH) treatment Saizen® on children with hypochondroplasia.   "
249164|NCT01111032|"     During this study the investigators will compare the use of two treadmill tests in people     diagnosed with cancer. The STEEP treadmill protocol is often used to evaluate the endurance     of people diagnosed with cancer, however, since it is based on step increases in speed or     ramp, it may not related to normal function. The new test, which is based on the body     response to increased activity has not been used with people with cancer but may provide a     better approximation of endurance demands during daily function. Our question is whether the     new treadmill test can be used to evaluate aerobic function with people with cancer better     than the STEEP treadmill test.   "
249165|NCT01111045|"     The objectives of the study are to evaluate the safety and efficacy of intraarticular BMP-7     for the treatment of osteoarthritis of the knee.   "
249166|NCT01111058|"     Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects     treated with everolimus versus placebo after definitive local therapy.   "
249167|NCT01111071|"     We seek to investigate whether hospitals in England and Wales vary in their rate of mortality     following admission for heart attack or unstable angina, the extent of such variation,     whether discharge diagnosis affects the extent of variation, and whether such variation has     changed over time. Furthermore, we will investigate what individual- or hospital-level     factors explain variation in mortality between hospitals.   "
249168|NCT01111084|"     This is a prospective and multicentric observational study to determine the real     mono-bifollicular development rate that is obtained under normal care conditions following     ovulation induction (OI) treatment with follitropin-alpha filled by mass prescribed in     accordance with standard practice.   "
249169|NCT01111097|"     The purpose of this study is to evaluate the safety and tolerability of oral Dichloroacetate     (DCA) in the treatment of recurrent malignant brain tumors (RMBTs). RMBTs are defined as     either: 1) malignant tumors, originating in the brain, that have recurred at least once or 2)     malignant tumors originating elsewhere in the body that have spread to the brain at least     once. Otherwise, there are no limitations to the number of prior recurrences. There are no     limitations to the number or types of prior therapies.   "
249170|NCT01111110|"     Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve     bronchodilator response during nocturnal bronchospasm.   "
249171|NCT01111123|"     The purpose of this study is to determine whether the combinational use of ammonium lactate     lotion 12% (Lac-Hydrin) and halobetasol propionate ointment 0.05% (Ultravate) is safe and     effective in the initial treatment and long-term maintenance of psoriasis. Patients will use     both medications continuously for two weeks and those who obtain a good improvement based on     investigator clinical assessments will be randomized to Lac-Hydrin lotion twice daily every     day with placebo ointment or Ultravate ointment twice daily on weekends only for up to 24     more weeks.   "
249172|NCT01111136|"     Stress and chronic urticaria has been linked. The purpose of the study is to evaluate a     patients chronic urticaria and stress levels before and after he/she goes through six     sessions designed to help that participant manage his/her stress.   "
249184|NCT01111292|"     This pilot, randomized phase I/II trial studies how well inositol works in preventing     colorectal cancer in patients with abnormal cells (dysplasia) associated with inflammation of     the colon (colitis). Patients with colitis-associated dysplasia may have an increased risk of     developing colorectal cancer. Inositol is a vitamin-like substance that may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth.   "
249174|NCT01111162|"     The overall goal of this study is to study influenza vaccine responses in HIV infected     individuals. Immunocompromised individuals require special protection from influenza, but may     not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu     vaccine as part of their standard of care will be asked to donate blood samples for     immunologic studies. These studies will determine whether participants were able to produce     the appropriate antibodies to the vaccine and possibly identify predictors of vaccine     responsiveness.      Our hypothesis is that vaccine responsiveness to the new H1N1 influenza vaccine will be     compromised in HIV infected patients.   "
249220|NCT01117194|"     The purpose is to study the effect of rehabilitation robot on shoulder training for stroke     patients.   "
249175|NCT01111175|"     Patients with metastatic or locally recurrent triple negative breast cancer (TNBC) who are     scheduled for medically indicated surgical biopsy or resection of disease will be identified.     Fresh/frozen tissue will be collected and will undergo comprehensive molecular evaluation     with NextGen sequencing. TGEN's clonal genomics analyses will be applied in the analysis to     identify and prioritize the mutated targets. Therapeutic options, based on the genetic     profile of each patient's tumor, will be discussed and an appropriate molecularly-selected     agent will be recommended by the Study Investigator(s) (SI) and treating oncologist as     treatment for the patient.      This is an open-label, pilot trial. Patients with metastatic or locally recurrent TNBC who     are scheduled for medically indicated surgical biopsy or resection will be enrolled and     therapeutic options, based on the genetic profile of each patient's tumor, will be discussed     with the patient.      Time-to-progression (TTP) for these patients following the selected therapy is the primary     objective and will be compared to the TTP(s) for their most recent prior therapy. A 30%     increase in TTP with the molecularly-targeted agent compared with the TTP on the immediate     prior therapy will be considered as evidence of clinical benefit from the selected therapy.     The secondary endpoints are best response to the molecularly-selected therapy, overall     survival (OS) and genetic mutation evaluation in metastatic (or locally recurrent) TNBC.      The study is designed to demonstrate that the collection and analysis of these tumor samples     is feasible.   "
249176|NCT01111188|"     Mantle cell lymphoma (MCL) is characterized by cell cycle dysregulation. PD 0332991 is a     cyclin-dependent kinase 4 and 6 inhibitor capable of inhibiting cell cycling of MCL. A phase     I study has demonstrated the safety and anti-lymphoma activity of PD 0332991. Bortezomib is a     first generation proteasome inhibitor approved for treatment of patients with recurrent MCL.     Preclinical data suggests that PD 0332991 and bortezomib may act synergistically in MCL.      PD 0332991 will be administered continuously for 12 days followed by a 9 day period without     treatment. Bortezomib will be administered by intravenous bolus on days 8, 11, 15, and 18 of     each cycle. One cycle is defined as three weeks. A maximum of ten cycles will be     administered.   "
249177|NCT01111201|"     This study also aims to raise awareness among both patients and health-care providers about     the importance of pre-travel health consultation and preventive interventions prior to     international travel.      Through appropriate health counseling, cancer patients will have less risk of having travel     -related health complications and thus have a better quality of life and overall improved     sense of wellbeing.   "
249178|NCT01111214|"     Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia, and pneumococcal     meningitis among infants and children worldwide. The 7-valent conjugate pneumococcal vaccine     (Prevenar) has been introduced in the Greek Market in 2004. Additionally, as of 2006 Prevenar     has been included in the Greek National Immunization Program.      The effect of the mass vaccination on the incidence of pneumococcal serotypes involved in the     occurring invasive pneumococcal disease, is an important factor to consider for the     introduction of the 13-valent pneumococcal conjugate vaccine.   "
249179|NCT01111227|"     The aim of this study is to assess the profile of cytokines IL-1beta, IL-6, IL-8, IL-10,     IL-12 and TNF-alpha under inhalation anesthesia with isoflurane and intravenous anesthesia     with propofol in healthy patients subjected to minimally invasive elective surgeries.   "
249180|NCT01111240|"     This study is a documentation of effectiveness and safety of Humira in patients with     psoriatic arthritis.   "
249181|NCT01111253|"     Rationale      The prevalence of colonic diverticular disease is increasing in Western countries.     Approximately 10 to 25% of patients with diverticular disease will eventually develop an     episode of acute diverticulitis. Currently conservative treatment often includes antibiotic     therapy. This advice lacks sound evidence and is merely based on experts' opinion. An old     clinical dogma is being clarified with this randomized trial.      Objective      Primary objective is to evaluate whether or not using antibiotics reduces to time to full     recovery of an attack of uncomplicated (mild) diverticulitis. Secondary objectives are to     evaluate complications, quality of life, readmission rate, recurrence rate, medical and     non-medical costs, and antibiotic resistance/sensitivity in both groups.      Hypothesis      The investigators hypothesis is that in the treatment of uncomplicated (mild) acute     diverticulitis, supportive treatment without antibiotics is a more cost-effective approach     than conservative treatment with antibiotics with respect to time-to-recovery as primary     outcome.      Study design      A randomized, open label, multicenter clinical trial comparing treatment of acute     uncomplicated diverticulitis with antibiotics to observation and supportive care alone.      Study population      Patients 18 years or older are eligible for inclusion if they have a diagnosis of acute     uncomplicated diverticulitis as demonstrated by imaging. Only patients with stages 1a and 1b     according to Hinchey's classification or mild diverticulitis according to the Ambrosetti     criteria are included.      Intervention      Conservative strategy with antibiotics: supportive measures and at least 48 hours of     intravenous antibiotics (and therefore admittance to the hospital) and subsequently switch to     oral antibiotics if tolerated (total duration of 10 days).      Control      Liberal strategy without antibiotics: supportive measures only. Observation and oral intake     as tolerated. Admittance only if discharge criteria are not met on presentation.      Main study parameters/endpoints      The primary endpoint is time-to-recovery with a 6-month follow-up period. Secondary endpoints     are occurrence of complicated diverticulitis requiring surgery or percutaneous treatment,     morbidity, health related quality of life, readmission rate, recurrence rate, medical and     non-medical costs, and antibiotic resistance/sensitivity.   "
249185|NCT01111305|"     Diethylcarbamazine citrate (DEC) treatment of Loa loa infection is complicated by the     development of severe adverse reactions that are correlated with the number of circulating     microfilariae in the blood. The cause of these reactions is unknown, but they are accompanied     by a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia and evidence of     eosinophil activation. This randomized, placebo-controlled, double-blind pilot study     (conducted at the NIH Clinical Center) will assess whether and to what extent the     administration of reslizumab (Cinquil ), a humanized monoclonal antibody directed against     IL-5, given 3 to 7 days before administration of the anthelminthic drug DEC (at 3 mg/kg 3     times daily for 21 days), prevents the development of eosinophilia in 10 adult subjects with     Loa loa infection and 0-5000 microfilariae/mL. Secondary outcomes will include the severity     of post-treatment effects, markers of eosinophil activation, and effects of reslizumab on     microfilarial clearance.   "
249186|NCT01111318|"     The main objective of this study is to assess the effect of mild, moderate and severe hepatic     impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral     administration of BI 10773 as a single dose.   "
249187|NCT01111331|"     The objective of the current study is to investigate the bioavailability of BI 10773 and of     warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of     warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the     pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral     administration of BI 10773.   "
249221|NCT01117220|"     The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective     for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or     Mixed).   "
249189|NCT01111357|"     Rheumatoid arthritis (RA), affects between 0.3% and 1.0% of the population, it can lead to     progressive joint destruction and severe disability. To date, two RA genetic susceptibility     factors have been identified: HLA-DRB1-SE (Shared epitope) and PTPN22 620W alleles. The     predictive value of the alleles for diagnosis of RA was previously investigated in cohorts of     caucasians patients with early unclassified arthritis that showed restrained association     between RA and HLA-SE. Despite the contribution of HLA to the overall genetic risk has been     estimated to range from 30% to 50%, it has never been studied in the French west-Indian     population.   "
249190|NCT01111370|"     The purpose of this study is to evaluate the safety and effectiveness of the G4 System when     worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin.      Device performance will be primarily evaluated in terms of the proportion of G4 System values     that are within ±20% of YSI reference value for glucose levels >80 mg/dL and ±20 mg/dL at     meter glucose levels <80 mg/dL. These G4-YSI matched pairs will be collected during in-clinic     sessions on Days 1, 4, and 7 of Sensor wear. The proportion of matched pairs from this study     (PTL-900360) meeting the above criteria will be compared to the proportion of such points     observed in the DexCom clinical study that supported approval of the SEVEN PLUS System (PTL     300012).      Safety data of the G4 System will also be collected and safety will be characterized by the     incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse     Device Effects experienced by study participants.   "
249191|NCT01111383|"     This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a     positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if     deemed appropriate by the Investigators will be able to be included in the 48-week follow-on     period (Extension Study) to continue the treatment only with Bramitob® (tobramycin nebuliser     solution, 300 mg twice daily in 4 mL unit dose vials).   "
249192|NCT01111396|"     There are two regions in the adult brain that exhibit neuronal stem and progenitor cells,     generating new neurons postnatally and throughout adulthood. One is the so called     subventricular zone the other is the dentate gyrus of the hippocampus. Adult neurogenesis is     a physiological process representing an important functional impact for certain brain areas,     especially the hippocampus. The hippocampal formation plays an important role in long-term     memory and spatial navigation. Inhibition of adult neurogenesis in mice by chemotherapy or     radiation is followed by significant deficits in hippocampal memory functions while     hippocampus-independent memory is unaffected.      Clinical trials had shown that chemotherapy and brain radiation lead to cognitive     dysfunction. However, the exact mechanisms underlying this phenomenon are still unidentified.      The aim of our study is to investigate, whether the inhibition of adult neural stem cell     proliferation in the hippocampus by intrathecal chemotherapy and/or cerebral radiation is     responsible for treatment induced memory deficits. We will investigate patients suffering     from acute lymphatic leukaemia (ALL) that receive prophylactic intrathecal chemotherapy and     brain irradiation. The study represents a longitudinal investigation including a virtual     humanized version of the morris-water-maze to test hippocampus dependent spatial memory, as     well as MR-imaging for morphological (volumetry) and biochemical (spectroscopy) data.   "
249193|NCT01111409|"     The primary objective of this pilot study is to evaluate the safety and effectiveness of the     VFIX device in maintaining vaginal apical support for at least 6 months in women with     symptomatic apical prolapse (upper vaginal or uterine prolapse).   "
249194|NCT01111422|"     Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal     dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage     during PD still remain unclear, generation of reactive oxygen species may be responsible for     progressive membrane dysfunction. N-acetylcysteine (NAC)is a powerful antioxidant shown to     protect peritoneal fibrosis in peritoneal dialysis animal model. In this study the     researchers investigated the hypothesis that NAC protect peritoneal membrane damage.   "
249210|NCT01117064|"     We are looking to test a novel device in the treatment of Obstructive Sleep Apnea (OSA).     Rather than using positive pressure to open the airways, we are testing a device that     delivers an auditory tone to affect neuromodulation. We will test its efficacy in treating     OSA while minimizing sleep disturbance. As this device is much less cumbersome to wear, we     hope this therapy device will also improve compliance with treatment.   "
249195|NCT01111435|"     This study is expected to contribute to the body of knowledge on the benefits of individuals     with MS taking glatiramer acetate (Copaxone®). If patients have less spasticity when taking     glatiramer acetate (Copaxone®), they may be more likely to have an improved quality of life.      The hypotheses for this study are:        1. Study participants who transition from interferon therapy to glatiramer acetate          (Copaxone®) for a six month period will have a decrease in spasticity.        2. Study participants who transition from interferon therapy to glatiramer acetate          (Copaxone®) for a six month period will have a change in perceptions of the impact of          spasticity on their lives.   "
249196|NCT01111448|"     The goal of this Pilot-study is to evaluate the response of unselected MDS patients to     temsirolimus a drug approved for the treatment of renal cell cancer. It is planned to give     temsirolimus at a weekly dose of 25 mg as intravenous infusion for a maximum duration of 12     months. Regular bone marrow biopsies are planned for controlling MDS response.   "
249197|NCT01111461|"     To assess the objective response rate (ORR: complete response + partial response [CR+ PR]) of     E7080 in subjects with unresectable endometrial cancer and disease progression following     platinum-based, first-line chemotherapy. .   "
249198|NCT01111474|"     This study aimed to evaluate the effectiveness of two treatments for dental hypersensitivity:     cyanoacrylate (Super Bonder®) compared with use of low intensity laser treatment. As the     cyanoacrylate is a lower cost treatment, the hypothesis in investigation is if this product     is equally effective as the laser treatment.   "
249199|NCT01111487|"     The objective is to evaluate whether the use of expiratory positive airway pressure (EPAP)     reduces the electrical activity of the sternocleidomastoid muscle and enhances the action of     the muscle in the patient parasternal ported from Chronic Obstructive Pulmonary Disease.     Noting also, if the set pressure level (10 or 15 cmH2O) affects this relationship.   "
249222|NCT01117233|"     The purpose is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of     PF-04427429 administered intravenously to healthy adult volunteers   "
249200|NCT01111500|"     Glenohumeral joint dislocation is the most frequent joint dislocation with a prevalence of     1.7/100000 citizens/year. It is treated by reduction, under sedation or anaesthesia, followed     by an immobilization of the arm.      The purpose of the study is to evaluate the healing of the labrum in first time anterior     glenohumeral joint dislocation with a Bankart lesion in young patients by comparing an     external rotation brace to an internal rotation brace to immobilize the injured arm.   "
249201|NCT01111513|"     Total knee replacement is a frequent procedure in Québec's hospitals and the muscular     strength of the quadriceps is the best indicator of the patient's functional recovery post     surgery. Thus, the importance of the patient's recovery leads to the evaluation of the     influence of the femoral nerve block on the muscle strength.      The purpose of the study is to compare the short term and long term recuperation of the     quadriceps' motor strength of after a total knee arthroplasty using different types of     analgesics such as the continuous femoral nerve block, the single dose femoral nerve block     and the systemic analgesic, a patient controlled analgesic pump.   "
249202|NCT01111526|"     To test a new agent, LBH589, in combination with glucocorticoids as initial therapy of acute     graft versus host disease (GVHD).   "
249203|NCT01111539|"     This will be a multicenter, randomized, double-blind study designed to assess the efficacy,     safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in subjects     with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram,     and report a treatment history for the current MDD episode of an inadequate response to at     least one and no more than three adequate trials of an approved antidepressant other than     Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive     symptom severity as assessed by the subject's self-report on the Massachusetts General     Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the     investigator as part of the subject's medical and psychiatric history. An adequate trial is     defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for     combination treatments) at an approved dose as specified in the ATRQ.   "
249204|NCT01111552|"     This will be a multicenter, randomized, double-blind study designed to assess the efficacy,     safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in subjects     with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram,     and report a treatment history for the current MDD episode of an inadequate response to at     least one and no more than three adequate trials of an approved antidepressant other than     Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive     symptom severity as assessed by the subject's self-report on the Massachusetts General     Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the     investigator as part of the subject's medical and psychiatric history. An adequate trial is     defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for     combination treatments) at an approved dose as specified in the ATRQ.   "
249205|NCT01111565|"     This will be a multicenter, randomized, double-blind study designed to assess the efficacy,     safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in subjects     with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram,     and report a treatment history for the current MDD episode of an inadequate response to at     least one and no more than three adequate trials of an approved antidepressant other than     Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive     symptom severity as assessed by the subject's self-report on the Massachusetts General     Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the     investigator as part of the subject's medical and psychiatric history. An adequate trial is     defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for     combination treatments) at an approved dose as specified in the ATRQ.   "
249206|NCT01111578|"     Investigators aim to evaluate the accuracy in the measurement of the esophageal and gastric     pressure of a new enteral feeding tube   "
249207|NCT01111591|"     In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with     COX2 inhibitor and assess survival rate and recurrent rate.   "
249208|NCT01111604|"     The purpose of this study is to determine if patients with metastatic colorectal cancer live     longer without their cancer progressing when treated with standard chemotherapy, standard     chemotherapy plus IMC-1121B, or standard chemotherapy plus IMC-18F1.   "
249209|NCT01111617|"     The goal of this research program is to determine the potential effectiveness of real-time     fMRI training in improving mental control over pain.   "
249211|NCT01117077|"     Infection accounted for the first cause of death in patients after liver transplantation, and     2 / 3 of the cause of death was fungal infections. The investigators group early found that T     cell subsets playing a role of inducing immune tolerance were significantly increased in vivo     of liver transplantation patients with aspergillus infection, which may be a kind of Treg     cells expressing IL-17. To explore the immune tolerance mechanism induced by the immune     balance cells is important to liver transplantation patients for improving efficacy and     reducing the mortality. Therefore, the investigators are going to get the blood sample and     liver tissue of the liver transplantation patients before and after treatment of aspergillus     infection, flow cytometry analysis of blood T cell subsets, Cytometric Bead Array to detect     changes in blood cytokines, laser capture microdissection to obtain liver biopsies of     inflammatory cells in portal area and further for analysis of T cell subsets and protein. And     the investigators are also to investigate the characteristics of CCR6 + CD4 + FOXP3 + Treg     cell clones secreting IL-17 and the capacity of which suppressing conventional T cell     proliferation. This study may find new methods, such as certain types of T cell subsets or     cytokines for the treatment of liver transplant patients, which not only to anti-rejection     but also to reduce fungal infection.   "
249212|NCT01117090|"     The purpose of this study is to record signatures from the fluid surrounding the spinal cord     from people who have an implanted drug infusion system.   "
249223|NCT01117246|"     This study is to confirm the safety and technical of MRI guided High Intensity Focused     Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases.      MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate     tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue.     The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be     performed in patients who pass inclusion/exclusion criteria.   "
249213|NCT01117103|"     This was an observational, prospective, multicentric study conducted in a cohort of subjects     with type 2 diabetes and prescribed with Glucophage XR therapy from hospitals or clinics in     Hong Kong, Indonesia, Korea, Malaysia, Philippines and Singapore. Glucophage XR is being used     in the Asia Pacific region for the treatment of subjects with type 2 diabetes. This study was     designed to provide information on the day to-day experience of using Glucophage XR in the     management of subjects with type 2 diabetes and its use in routine clinical practice in Asia     Pacific region.   "
249214|NCT01117116|"     The purpose of this study is to look at whether Advair® and SYMBICORT® have different effects     on airway constriction by means of methacholine challenge testing.   "
249215|NCT01117129|"     This randomized, double-blind, placebo controlled, parallel group study will assess the     efficacy and safety of rituximab [MabThera/Rituxan] in patients with severe active rheumatoid     arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging     (MRI) of the hand for efficacy measurement. Patients will be randomized to receive 2     intravenous infusions 14 days apart of either 1000mg MabThera (group A) or placebo (group B).     All patients will receive methotrexate 10-25mg weekly. Patients in group A demonstrating     clinical response at week 24 may receive further cycles of MabThera, patients in group B     without clinical response will also be treated with active MabThera. Anticipated time on     study treatment is up to 2 years. Target sample size is <50 patients.   "
249216|NCT01117142|"     Background:        -  Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell          lymphoma (MCL) are types of cancers in which there are too many abnormal lymphocytes (a          type of white blood cell). Monoclonal B-cell lymphocytosis (MBL) is a condition in which          the individual has a larger than normal number of lymphocytes. Individuals with CLL,          SLL, MBL, and MCL may survive for many years without the need for treatment, but there          is an apparent correlation between cell birth rates and disease activity. By studying          the birth and death rates of lymphocytes, researchers hope to identify individuals who          are at risk for worsening disease.        -  Heavy water is similar in structure to regular water, but it has two deuterium atoms          instead of two hydrogen atoms. Deuterium has one more neutron than hydrogen, which is          what makes heavy water heavy. Heavy water is not radioactive, looks and tastes like          regular water, and has no known harmful effects at research-level doses. When a small          amount of heavy water is consumed daily, newly produced blood cells are labeled          (tagged), which allows researchers to track cell growth and to measure the birth and          death rates of CLL, SLL, MBL, MCL or normal lymphocytes.      Objectives:      - To study the birth and death rates of lymphocytes from individuals with MBL, CLL/SLL, and     MCL, compared with lymphocytes from healthy volunteers.      Eligibility:        -  Individuals at least 18 years of age who have been diagnosed with MBL, CLL, SLL, or MCL,          but who have not been taking certain agents (Viagra, Levitra, Cialis, or other          PDE-inhibitors, prednisone, cyclosporin-A, rapamycin, or other immunosuppressive agents,          more than 2 cups of green tea daily, or Celebrex) for 4 weeks prior to enrollment in the          study.        -  Healthy volunteers at least 18 years of age, but who have not been taking certain agents          (Viagra, Levitra, Cialis, or other PDE-inhibitors, prednisone, cyclosporin-A, rapamycin,          or other immunosuppressive agents, more than 2 cups of green tea daily, or Celebrex)for          4 weeks prior to enrollment in the study.      Design:        -  Participants will be screened with a medical history, physical examination, and initial          blood tests. Other tests may be administered to the individuals with cancer, as required          by the study researchers.        -  All participants will drink regular doses of heavy water daily for a total of 4 weeks          (labeling period). There is an optional 6-month follow-up or wash-out period during          which no additional heavy water will be consumed.        -  Blood samples will be collected weekly during the labeling period, and a bone marrow          biopsy will be obtained where possible. Individuals with cancer may also have a lymph          node biopsy during this part of the study.        -  Additional blood samples may be collected during the optional wash-out phase of the          study to determine the rate at which cancer cells disappear.        -  Treatment is not provided as part of this protocol.   "
249217|NCT01117155|"     Background:        -  Children with brain tumors often have magnetic resonance imaging (MRI) scans to see if          the tumor has responded to therapy or to see if the tumor has grown. Sometimes, it is          difficult to tell if the scan is abnormal because of tumor size or shape, swelling, scar          tissue, or dead tissue. Because brain tumor biopsies require surgery, researchers are          looking for more noninvasive ways of evaluating brain tumors.        -  Positron emission tomography (PET) scans use a radioactive sugar known as 18F-FDG to try          to determine if a tumor is active or not. Active tumors generally take up more sugar          than the surrounding tissue, but because normal brain tissue uses the same sugar as          brain tumors, it is then difficult to tell if tumor tissue is taking up sugar or not. A          different radioactive agent, 18F-FLT, is now being studied in some adults with different          kinds of tumors. Researchers are interested in determining whether it is possible to use          this agent as a marker of tumor activity in children.      Objectives:        -  To determine the safety and effectiveness of 18F-FLT for pediatric glioma scans.        -  To compare the results of 18F-FLT studies with studies using the radioactive agents          18F-FDG and 1H-MRSI.      Eligibility:      - Children less than 18 years of age who are having radiation therapy to treat malignant     gliomas.      Design:        -  Participants will have scanning tests before radiation therapy, 1 to 3 weeks after          radiation therapy, and if researchers suspect that the tumor is growing.        -  This study will involve three separate imaging tests (1H-MRSI, 18F-FDG PET, and 18F-FLT          PET).        -  Proton spectroscopy (1H-MRSI) is a procedure that is similar to MRI and is performed in          the same scanner as an MRI. Because this scan is long (2-3 hours), most children will          receive medications from an anesthesiologist so that they can sleep through the          procedure.        -  Within 2 weeks of the 1H-MRSI scan, participants will have the PET scans with both the          standard contrast agent (18F-FDG) and the experimental agent (18F-FLT). These scans will          last approximately 1 hour each.   "
249232|NCT01117376|"     42 patients admitted in ICU with intolerance to enteral feeding (GRV more than 250 ml) are     recruited. All patients enter a primary acetaminophen absorption test study as baseline.     Serum levels of acetaminophen will be measured by florescence polarization method at     15,30,45,60,90,120,180,240,480 minutes after enteral administration of 975 mg acetaminophen.     Then the patients will be randomized to methylnaltrexone or erythromycin group.Another     acetaminophen absorption test with the same schedule will be done after the last dose of each     drug.The area under the curve for acetaminophen blood level will be used to compare the     effect of two studied drugs on gastric emptying time.   "
249315|NCT01119365|"     Light is the primary means by which the internal circadian clock remains aligned     (entrained) with the external world. Misalignment of this internal clock can occur during     situations such as shift work and jet travel across multiple time zones (jet lag). The     purpose of this study is to examine the parameters of light and how they affect entrainment     of the clock.   "
249218|NCT01117168|"     Background:      - The Children s Oncology Group has established a research network, the Childhood Cancer     Research Network (CCRN), to collect information about children with cancer and other     conditions that are benign but involve abnormal cell growth in order to help doctors and     scientists better understand childhood cancer. The CCRN's goal is to collect clinical     information about every child diagnosed with cancer and similar conditions in the United     States and Canada, to allow researchers to study patterns, characteristics, and causes of     childhood cancer. The information can also help researchers study the causes of childhood     cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be     asked to provide information about themselves and their child for research purposes.      Objectives:        -  To obtain informed consent from parents (and the child, when appropriate) of infants,          children, adolescents, and young adults newly diagnosed with cancer to enter their names          and certain information concerning their child into the Childhood Cancer Research          Network.        -  To obtain informed consent from parents (and the child, when appropriate) of infants,          children, adolescents, and young adults newly diagnosed with cancer for permission to be          contacted in the future to consider participating in non-therapeutic and prevention          research studies involving the parents and/or the child.      Eligibility:      - Parents of children who have been seen at or treated by a hospital that is a member of the     Children s Oncology Group.      Design:        -  Parents will provide permission to have personal information sent from their child s          hospital to the CCRN, including the child and parents' names; child's gender, birth          date, race, and ethnicity; information about the disease; and the treating institution.        -  Parents will also give permission for CCRN to contact the diagnostic laboratory to          obtain specific information about the tumor or cancer cells.        -  Parents will be asked if they are willing to be contacted in the future to consider          participating in CCRN research studies, and will provide contact information (name, home          address, and telephone number) to be entered in the CCRN.        -  Parents or patients who change their minds about having information available in the          CCRN can ask the treatment institution to restrict access to the identifying          information. Parents or patients who refuse to have information included in the CCRN or          be contacted in the future will still be able to enter clinical cancer research studies.   "
249219|NCT01117181|"     The Apathy in Dementia Methylphenidate Trial (ADMET) is a masked, placebo-controlled trial     that will examine the efficacy and safety of methylphenidate for the treatment of clinically     significant apathy in patients with Alzheimer's dementia.   "
249224|NCT01117272|"     Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder of reproductive-age     women. According to Rotterdam 2003 criteria: at least two of three criteria are met,     hyperandrogenism, chronic anovulation, and polycystic ovary. PCOS will cause irregular     menstrual cycle, infertility, acne, hirsutism, obesity, or/and metabolic syndrome, diabetes     that may increase risk of cardiovascular disease.      Hyperprolactinaemia is also a common problem in reproductive aged women. Both     hyperprolactinaemia and PCOS had endocrine disorder and irregular menstrual cycle.     Investigators hope to collect clinical data from PCOS and prolactinemia patients followed in     Wang Fang hospital for many years in endocrinological and metabolical aspects for comparison.     Investigators at the same time would like to understand more about other similarities and     differences between these two endocrinological dysfunction for future study.   "
249225|NCT01117285|"     The main purpose of this cluster randomized controlled trial is to evaluate the difference in     effectiveness between a combined implementation strategy and an educational strategy on the     implementation of a community occupational therapy program for clients with dementia and     their primary caregivers.   "
249226|NCT01117298|"     Raynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many     patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity     and adversely affects the quality of life. In an earlier study, we have observed marked     improvement in RP attacks and rapid healing of digital ulcers following therapy with     phosphodiesterase V inhibitor, Tadalafil. In the present multicentric study we aim to study     the efficacy of Tadalafil in patients continuing to have RP attacks despite using at least     one or more vasodilators.   "
249227|NCT01117311|"     The overall aim of this application is to determine the mechanism(s) by which common     bariatric surgical procedures alter carbohydrate metabolism. The study proposed will examine     the effect of vagal nerve stimulation on insulin secretion and action.   "
249228|NCT01117324|"     Bone density was found to be impaired among lage babies and infants of diabetic mothers as     found in small group studies. The assumption is that large weight decreases fetal movements     and causes decreased bone mineralization.The aim of the study is to compare 2 study groups -     of large infants and infants of diabetic mothers to each other and to controls.   "
249229|NCT01117337|"     The purpose of the study is        1. To compare the recurrence rate of the laparoscopic total extra peritoneal inguinal          hernia repair without fixation of the mesh to mesh fixation under spinal anesthesia        2. To test whether non-fixation of mesh leads to less pain compared to the repair when the          mesh is fixed.   "
249230|NCT01117350|"     Primary objective:      To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of     patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative     period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents      Secondary objectives of the comparative period (24 weeks):      >To assess the effect of insulin glargine in comparison with liraglutide on:        -  HbA1c level        -  Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the          comparative period        -  Percentage of patients whose HbA1c has increased at the end of the comparative period        -  Fasting Plasma Glucose (FPG)        -  7-point Plasma Glucose (PG) profiles        -  Hypoglycemia occurrence        -  Body weight        -  Adverse events      Objectives of the extension period (24 weeks):      >To assess the effect of insulin glargine in patients not adequately controlled with     liraglutide on:        -  HbA1c level        -  FPG        -  7-point PG profiles        -  Hypoglycemia occurrence        -  Body weight        -  Adverse events   "
249231|NCT01117363|"     Acute hunger-reducing effects (8h) has been documented for rye porridge breakfast compared     with iso-caloric referenced refined wheat reference breakfast. The primary aim of the current     study is to investigate whether this effects remains at regular consumption. A secondary aim     is to compare the orocecal transit time (OCTT) between the two breakfasts.   "
249233|NCT01117389|"     This study will focus on the primary objectives:        -  To estimate the prevalence of HPV vaccination among a large cohort of childhood cancer          survivors and an acquaintance control group.        -  To describe the difference in HPV vaccination rate and HPV vaccination intent among          preadolescent/adolescent females surviving childhood cancer and an acquaintance control          group.      This study will also focus on the secondary objectives:        -  To examine sociodemographic, medical, and psychological differences between those who          have/have not initiated HPV vaccination and between those who do/do not intend to get          vaccinated in the future.        -  To assess the general predictive influence of sociodemographic, medical, and          psychological variables on HPV vaccination and intent among mothers with          preadolescent/adolescent daughters.   "
249234|NCT01117402|"     Radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix.     However it is technically difficult to deliver adequate doses of RT due to presence of small     intestines in the radiation area; thus disease control rates are poor and complication rates     are high with conventional radiotherapy. Use of IMRT and brachytherapy for these cases allows     for increasing dose to the tumor while sparing normal structures. It is expected that the use     of a combination of IMRT & brachytherapy will achieve higher disease control rates and     decrease the complication rates.   "
249235|NCT01117415|"     Participation in this research study does not involve any procedures. Health preference will     be ascertained through standard techniques including time-tradeoff, standard gamble, and     rating scale to assess risks regarding potential complications specific to NOTES (Natural     Orifice Translumenal Endoscopic Surgery)gallbladder removal.   "
249236|NCT01118325|"     The purpose of the study is to determine the drug characteristics of Ticagrelor, and to     determine if 4 weeks treatment will reduce the blood clotting.   "
249237|NCT01118351|"     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth or by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients     with recurrent transitional cell bladder cancer.   "
249238|NCT01118364|"     Assess the effect of cigarette smoking of tobacco with or without addition of resin cannabis     on driving performance in healthy volunteers in simulated driving in Marseille and Toulouse,     and in real world driving to Bordeaux.      Multicenter Study of phase 1, randomized, double-blind, cross plan, carried out in healthy     male volunteers.   "
249241|NCT01118403|"     This study seeks to assess whether coma patients really benefit from the use of antibiotics     as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this     population group. For this we consider the use of ampicillin sulbactam antibiotic which has a     low ability to induce resistance, efficacy and safety observed during the time that has been     used, even in patients with neurosurgical pathology, and to be broadly available in our     environment.      Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation,     the application of antibiotic prophylaxis compared with placebo reduces the incidence of     early ventilator-associated pneumonia.   "
249242|NCT01118416|"     The primary aim of this study is to test a brief 4-session risk reduction intervention, based     on Motivational Enhancement Therapy (MET) to reduce the co-occurrence of club drug use and     sexual risk taking behaviors among non-treatment seeking young men who have sex with men     (YMSM) in NYC.   "
249243|NCT01118429|"     The objective of this study was to evaluate the effectiveness and patient satisfaction with     the use of oxybutynin at low doses for treating axillary hyperhidrosis in a large series of     patients.   "
249244|NCT01118442|"     Narrowing of the main valve which controls blood leaving the heart leads to a marked increase     in death. To overcome this narrowing the heart muscle thickens abnormally and contracts more     vigorously. However, in doing so, blood flow patterns to the heart muscle change through     mechanisms which are incompletely understood. New technology allows such heart valve     blockages to be fixed using balloons and metal stents inserted through tubes placed in     arteries in the leg. Using sensors placed in these tubes it is possible to make detailed     measurements of coronary flow and pressure, and apply new mathematical techniques to allow a     better understanding of the detrimental effects that aortic stenosis has on coronary flow,     before and after valve surgery.   "
249245|NCT01118455|"     This is a randomized study designed to compare long-term treatment outcomes in pediatric     patients with refractory seizures treated with VNS (Vagus Nerve Stimulation) Therapy versus     anti-epileptic drugs (AEDs). Seizure reduction, quality of life measures, and side effect     profiles will be evaluated. The results of this study will provide controlled comparative     data to better guide physicians in determining the best overall treatment strategy for     patients with seizures who have failed initial AED therapy.   "
249246|NCT01118468|"     Narrowing of the arteries that supply blood to the heart can lead to heart attacks and death.     One way of treating this is to use artery and vein grafts from other parts of the body to     bypass the narrowing. However, the blood flow from these grafts competes with flow through     the natural coronary artery. This may contribute to grafts narrowing with time. This protocol     aims to determine the pressure changes responsible for this effect. This could improve our     understanding of why some grafts last longer than others.   "
249247|NCT01118481|"     Narrowing of coronary arteries interferes with blood flow and can cause chest pain.     Cardiologists sometimes quantify the extent of the narrowing by measuring the fractional flow     reserve (the ratio of the pressure in the aorta to the pressure downstream of the narrowing     under conditions of maximal flow). We propose a new technique based on principles of wave     intensity analysis (WIA) to better assess coronary stenosis and the significance of the     narrowing without the need for administration of vasodilator agents such as adenosine. This     would simplify assessment and improve our ability to advise patients whether stent treatment     will help their symptoms.   "
249347|NCT01119794|"     The purpose of this study is to: Investigate the Overall Response Rate (ORR) of the     combination of ofatumumab and bortezomib in patients with low-grade B-cell non-Hodgkin     lymphoma (LG-NHL) that relapse beyond 6 months of a previous rituximab-containing regimen.   "
249248|NCT01118494|"     Chronic kidney disease (CKD) that results in end-stage renal disease (ESRD) is a major     international health problem. Many clinical markers such as urine protein or eGFR(evaluated     glomerular filtration rate),can estimate the renal function, but not sensitive. As     well-known, the crucial role of angiotensin II (AngII), the major effector of the     renin-angiotensin system (RAS), in the development of renal fibrosis that results in ESRD is     widely recognized.Abundant researches find that intrarenal RAS takes an important role on the     progression of CKD. At present, no clinical marker is available to evaluate intrarenal AngII     activity because it is difficult to measure it directly in patients. So find and establish a     bio-marker of local renal RAS activation maybe a breakthrough in early detection and     treatment of CKD. Angiotensinogen(AGT) is the only known substrate for renin and the level of     AGT in humans is close to Km value for renin. Thus , changes in AGT levels can control the     activity of the RAS, and its up-regulation may lead to activity of Ang levels. Then we     hypothesis that the AGT is a early bio-marker of local renal RAS activation as well as CKD.   "
249249|NCT01118507|"     Demonstrate that the High output shotgun sequencing of the foetal DNA in the maternal blood     could allow a complete discrimination between the mothers of a trisomic fetus 21 or a     DISOMIQUE foetus 21 from the first quarter of the pregnancy, and so to obtain a reliable     alternative in invasive procedure.   "
249262|NCT01118676|"     This is a two-center study which includes 24 patients maximum on 36 months : 24 months     accrual - 12 months follow up.      Eligible patients are included according to a standard 3+3 design.      Patients included in the trial will be treated with a combination of radiochemotherapy     (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based     chemotherapy).      Cilengitide will be administered alone as continuous infusion two weeks before the     radiochemotherapy and will then be continued during radiochemotherapy as continuous infusion.      The dose levels investigated will be applied to the continuous administration (a maximum of 4     dose levels).      After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a     dose of 2000 mg twice weekly until the end of chemotherapy.      The dose of Cilengitide administered after radiotherapy will not be increased. 4 dose levels     are defined:12, 18, 27 et 40 mg /hour.   "
249263|NCT01118689|"     The purpose of this study is to determine the safety, tolerability, maximum tolerated dose     and pharmacokinetics of MLN0128 in patients with Relapsed or Refractory Multiple Myeloma or     Waldenstrom Macroglobulinemia   "
249264|NCT01118702|"     This is a study of blood plasma levels of methylphenidate in healthy volunteers over a 24     hour period after they take this medication.   "
249550|NCT01122589|"     The purpose of this study is to determine the extent to which an Intentional Behavioral     Intervention will increase tobacco quit rates post release among incarcerated men and women.   "
249250|NCT01118520|"     Abdominal aortic aneurysms (AAA) are balloon-like swellings of the body's main blood vessel     (aorta) as it courses through the abdomen. As a result of the National Aneurysm Screening     programme many more of these will be detected. Small AAAs grow slowly and remain a benign     condition until the diameter exceeds 2-3 times the diameter of the normal aorta (about 5.5cm     in size), when operative repair of the aneurysm is recommended avoiding the potentially fatal     event of bursting and bleeding (aneurysm rupture). It is therefore important to identify a     strategy to prevent aneurysm growth.      There is a suggestion that the use of a specific drug class, angiotensin converting enzyme     (ACE) inhibitors, may reduce the risk of rupture of the larger aneurysms. This trial will     assess whether an ACE inhibitor (perindopril) has aneurysm-related benefits, in patients with     small AAAs at screening centres in the London area.      The effects of perindopril versus a placebo(dummy) on AAA growth rates will be compared. In     addition by comparing the effects of perindopril with the effects of equivalent blood     pressure lowering with another non-ACE inhibitor class of drug (amlodipine) on aneurysm     growth rate, we can see whether any benefits of perindopril are simply the result of lowering     blood pressure. 225 Patients will be assigned to one of these 3 treatments by chance     (randomisation).In addition to analysis of the effect of perindopril and blood pressure     lowering,the effect of the treatments on quality of life will be assessed. Patients will     return at 3-monthly intervals for an ultrasound scan and blood pressure measurements, with     questionnaires regarding quality of life at the start and end of the 2-year research period.      An ultrasound scan is a painless test that uses sound waves to create images of organs and     structures inside your body.   "
249251|NCT01118533|"     Orotracheal intubation following general anesthesia requires blades to be performed. The risk     of patients contamination with infectious agents related to reusable metal blades leads to     promote single-use blades. Some of these latter are plastic and this material may need more     strength to lift the jaw and expose the larynx before orotracheal intubation. Sometimes,     change of blade, from plastic to metal, during the procedure is necessary to increase the     larynx exposure. This change of blade may increase the frequency of sore throat following     orotracheal intubation.      Consequently, the study hypothesis is an increase of both sore throat intensity and frequency     with the plastic blades compared with the metal blades.      The primary purpose of the present study is to compare the impact of these two types of     blades, metal versus plastic, on sore throat intensity and frequency following scheduled     orotracheal intubation for general anesthesia   "
249252|NCT01118546|"     Aspirin is very effective in protecting patients with coronary artery disease against adverse     cardiac events, because it is a potent antiplatelet agent. Some patients may develop a     history of hypersensitivity to aspirin and treatment cannot usually be resumed in these     patients. We have developed a rapid procedure to induce tolerance in these patients     (SILBERMAN et al, Am J CARDIOL 2005;95:509-10) and wish to test whether aspirin is as     effective as antiplatelet agent in patients with a history of allergy to aspirin and who     undergo desensitization as it is in patients without history of hypersensitivity   "
249253|NCT01118559|"     This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male     adult subjects.   "
249254|NCT01118572|"     Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in     patients with postoperative pain.   "
249255|NCT01118585|"     The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD     patients treated in routine clinical practice at multiple centers across the United States.   "
249256|NCT01118598|"     Niacin will improve postprandial hyperlipidaemia and cardiovascular risks indices via its     lipid lowering as well as via pleiotropic effects in patients with polycystic ovary syndrome     (PCOS).   "
249257|NCT01118611|"     RATIONALE: Aurora B/C kinase inhibitor GSK1070916A (GSK1070916A) may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of GSK1070916A in     treating patients with advanced solid tumors.   "
249258|NCT01118624|"     The purpose of this study is to determine the efficacy (ability to provide a beneficial     treatment of the disease) of pralatrexate for the treatment of female patients with advanced     or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin     B12 and folic acid supplementation.   "
249274|NCT01118832|"     A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions     and melanoma is developed. Goals include evaluation of the utility of high-resolution     infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the     identification of high-risk lesions and melanomas.   "
249275|NCT01118845|"     The purpose of this study is to determine the efficacy of SyB L-0501 in combination with     rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.   "
249330|NCT01119573|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research study is studying at biomarkers in tissue samples from patients with     stage I or stage III endometrial cancer.   "
249259|NCT01118637|"     Trichotillomania (TTM), repetitive pulling out of one's own hair to the extent that     noticeable hair loss occurs, is a distressing condition interfering substantially with     functioning and quality of life. The longterm objective of this research is to determine     whether psychological treatment of TTM could be disseminated more effectively by using a     stepped care model in which less intensive interventions are tried first, with more intensive     interventions used only if initial treatment proves insufficient. This project is a pilot     study of the first two steps in a stepped care model of treatment. After baseline assessment,     50 participants with TTM will be randomly assigned to (a) Immediate condition, in which they     are offered 10-week self-help treatment via an interactive website (Step 1) or (b) Wait     List/Delayed Start condition, a 10-week wait list prior to being offered Step 1. In each     condition, at the end of Step 1, participants will be offered 8 weeks of in-person habit     reversal training provided by psychology graduate students (Step 2). TTM symptoms will be     measured from baseline through a follow-up 3 months after the end of Step 2, as will     depression, anxiety, quality of life, functional impairment , treatment utilization, and     treatment satisfaction.      The specific aims of the study are:        1. To gather preliminary data on the efficacy of web-based self-help, compared to wait list          control;        2. To characterize the acceptability of stepped care to patients with TTM by assessing the          proportion of enrolled participants who proceed from step 1 to step 2 treatment;        3. To evaluate the convergent validity of four decision rules for concluding that a patient          with TTM has benefited sufficiently from a treatment step: (a) No longer meeting TTM          diagnostic criteria; (b) Showing a 25% or greater reduction in total scores on          self-report and clinician-rated TTM symptoms; (c) achieving complete abstinence from          hair-pulling; and (d) clinically significant response on both self-report and          clinician-rated TTM symptom measures        4. To evaluate the concurrent and predictive validity of criteria for sufficient benefit          from a treatment step by relating them to treatment satisfaction, treatment utilization,          and scores on a measure of functional impairment from TTM.   "
249265|NCT01118715|"     Distal radius fractures (DRF) are the most common type of fracture in the human body, and a     large proportion of DRFs result in complications. Previously proposed preventive strategies     have questionable efficacy and may impose additional risks on the patient. Because many     complications secondary to distal radius fractures are associated with excessive swelling, a     prophylactic means for edema reduction could dramatically reduce morbidity among this     population. A compression glove is a non-invasive, non-pharmacological way to reduce edema.     Previous studies have confirmed its utility in edema reduction after hand trauma and among     patients with chronic inflammatory conditions, but none have sufficiently investigated the     application to patients with distal radius fractures, a population in which this intervention     could have a large impact. The investigators propose a randomized controlled trial to     evaluate use of a compression glove during recovery among patients who have sustained an     unstable distal radius fracture. The investigators hypothesize that patients who wear a     compression glove after a distal radius fracture:        -  Will experience less edema        -  Will demonstrate greater functionality        -  Will recover more quickly        -  Will have lower incidence rates of carpal tunnel syndrome        -  Will have lower incidence rates of complex regional pain syndrome   "
249266|NCT01118728|"     Primary Objective:        -  To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with          ankylosing spondylitis (AS)      Secondary Objective:        -  To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS   "
249267|NCT01118741|"     disulfiram is a DNA methyltransferase inhibitor that may provide benefit for patients with     prostate cancer by restoring tumor suppressor genes.   "
249268|NCT01118754|"     The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and     effectively improve signs and or symptoms of dry eye disease.   "
249269|NCT01118767|"     The investigators propose to develop and evaluate a computer-based intervention using cell     phones to enhance adherence to antiretroviral treatment (ART) and support of HIV transmission     risk-reduction among adult HIV-positive patients in Peru.   "
249270|NCT01118780|"     The purpose of this study is to test the safety and efficacy of duloxetine versus placebo in     elderly patients suffering from generalized anxiety disorder (GAD).   "
249271|NCT01118793|"     This is a Scripps pilot study on the effect of high clopidogrel maintenance dosing and its     relationship to cytochrome P450 2C19 polymorphism status [STSI/CTSA].   "
249272|NCT01118806|"     the study aims to messure the vitamin D levels in medical staff in the hospital. The     physicians in the course of their internship who work indoors and work many night shifts have     limited sun exposure in all seasons. Nursing staff who work shifts and work indoors are at     the same risk of liltle sun exposure. The study addresses the amount of sun exposure,     assessed by a sun exposure questioner, age, gender,work load related to number of shifts in     the physicien group and in nursing group the job percentile we also adress religion (clothing     cover)as a factor.   "
249273|NCT01118819|"     This protocol will examine the safety of intravenous administration of Clostridium novyi-NT     spores in patients with treatment-refractory solid tumor malignancies. This investigational     study will measure anti-tumor activity of C. novyi-NT administered intravenously in patients     with treatment-refractory solid tumor malignancies.   "
249348|NCT01119807|"     The objective of this study will be to compare humeral and tibial IO needle insertions to     peripheral IV access during cardiac arrest.      Hypothesis There is a difference in first attempt success of tibial IOs compared to humeral     IOs or peripheral IV among cardiac arrest patients.      Methods This will be a randomized controlled trial conducted within Mecklenburg County by the     Mecklenburg County EMS Agency (MEDIC). The study population includes all adult (greater than     18 years of age) cardiac arrest patients of a medical etiology upon whom resuscitative     efforts are initiated.      Patient Care Protocols Prehospital protocols for adult cardiac arrest patients within     Mecklenburg County state that all first responders follow advanced cardiac life support     (ACLS) algorithms during cardiopulmonary resuscitation. Current MEDIC protocols specify that     initial vascular access be obtained by paramedics via either tibial or humeral IO needle     insertion, followed by peripheral IV for secondary access. This study will randomize initial     vascular access to a humeral IO, tibial IO, or peripheral IV.      Once paramedics arrive on-scene, they will take a pack from the ambulance containing all     necessary supplies to begin resuscitation. These packs are already present on each ambulance     in Mecklenburg County and contain an EZ-IO drill, IO needles, ACLS medications, and KING LTD     airway device. For the purposes of this study, peripheral IV start kits will be added to     these resuscitation packs at the start of study implementation.      Randomization Process      150 note cards will be prepared in advance and labeled with a vascular access method. [50     cards with Tibial IO, 50 cards Humeral IO, 50 cards with Peripheral IV] Each note card     will be sealed in a blank, numbered envelope. A master list will be prepared in advance     according to envelope number indicating which vascular access method was placed in each     numbered envelope. This list will only be available to the MEDIC Quality Assurance/Quality     Improvement (QA/QI) personnel responsible for paramedic debriefing and recirculation of     unused envelopes.      Sealed envelopes will then be shuffled and placed at the MEDIC circulation window where     resuscitation packs and ambulance equipment are distributed daily.      Each crew will randomly select and open an envelope prior to every shift. By opening the     envelope at the start of the day, this will eliminate the possibility of envelopes being left     in the ambulance unit or lost at the scene, as well as prevent delays with patient care.      The envelope number will be recorded at the circulation window indicating the specific MEDIC     ambulance unit and assigned crew.      The vascular access route selected will apply to the crew's first cardiac arrest of the day.      Resuscitation Protocol      Paramedics will conduct the resuscitation according to existing procedure, and will proceed     with vascular access as follows depending on the method selected by randomization:      Tibial IO First attempt will be a tibial IO. Second attempt should occur on the opposite     tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as     selected by the paramedic.      Humeral IO First attempt will be a humeral IO. Second attempt should occur at the tibia if     the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs     as determined by the paramedic.      Peripheral IV First attempt will be a peripheral IV in the AC. If this fails, second attempt     will be a tibial IO, followed by a humeral IO when indicated.      Since it is extremely rare for any crew to conduct more than one cardiac arrest on a given     day, the randomized vascular access method will only apply to the first cardiac arrest of the     day. As crews do not return to the distribution center until the end of a shift (12 hours),     it will be impossible to select additional envelopes for subsequent patient encounters.     Paramedics will proceed with vascular access per current MEDIC prehospital protocols for any     further cardiac arrest resuscitations that day.      If there is a contraindication to the vascular access site selected such as extremity     amputations, orthopedic hardware, skin infection, or traumatic injuries, paramedics will     proceed to the next insertion site as per the above protocol. For instance, if a patient with     bilateral lower extremity amputations is randomized to a tibial IO insertion site, paramedics     will classify this as a failed attempt and proceed to humeral IO, then peripheral IV as     stated above. For patients with isolated skin infections or orthopedic hardware involving one     extremity, paramedics will select the unaffected extremity for the first attempt. Any     unforeseen circumstances will be addressed according to the paramedics' discretion and     reported to the primary investigator immediately. Such occurrences will be included in the     final data analysis for this study.   "
249276|NCT01118858|"     Cytochrome P450 2D6 (CYP2D6) is an important enzyme in the body for breaking down many     medications that are commonly used in children of various ages. The purpose of this proposal     is to investigate the relative roles of development and genetic variation in CYP2D6 activity     in school-aged children and adolescents with attention deficit and hyperactivity disorder and     health controls using the over-the-counter cough suppressant, dextromethorphan or DM, a     standard probe for determining CYP2D6 phenotype. Embedded in the study design are sub-studies     to search for by-products of normal body metabolism that reflect differences in enzyme     activity, and a pharmacokinetic study to assess the consequences of CYP2D6 genetic variation     on the systemic exposure to medications used by this patient population. Ultimately, the goal     of the research is to personalize the use of medications in children by selecting the     appropriate dose of the correct medication for individual patients.   "
249277|NCT01118871|"     The purpose of this study is to look at two different antiretroviral treatment options in     individuals who are about to commence their second antiretroviral treatment.      This study will assess important clinical and laboratory differences between these two     therapeutic options. Potential differences include: differences in body fat distribution, in     lipid parameters, in adherence and in neurocognitive (brain) function. This study is looking     to show differences in body fat distribution between the two study treatment arms.     Differences in lipids, viral load, adherence, cardiac and bone biomarkers and neurocognitive     function will also be assessed. There is also a lumbar puncture sub study participants can     also take part in.      The total duration of involvement in the trial will be up to 96 weeks (approximately 2 years)     plus a screening visit 1 - 4 weeks prior to the start of the study. Including visit the     clinic on 12 occasions (screening visit, baseline visit, weeks 2, 4, 8, 12, 24, 36, 48, 64,     80 and 96)   "
249278|NCT01118884|"     The purpose of this study is to compare the safety and efficacy of sedation using orally     administered midazolam and promethazine with nitrous oxide/oxygen in uncooperative children     receiving dental treatments.   "
249293|NCT01119079|"     In current obstetric anesthesia practice, epidural analgesia is the most effective technique     to control labor pain for those women who request pain-free delivery. Epidural analgesia not     only allows us to obtain greater pain relief and increased satisfaction of mothers, but also     permits us to convert it to regional anesthesia in case of operative delivery, avoiding     general anesthesia.      One of the major concerns with epidural anesthesia in labor setting is the inability to     produce an intensive analgesia or adequate level to proceed with cesarean section. This study     is designed to examine the hypothesis that 10ml epidural normal saline to reduce rate of     one-side block, low segmental block, and patch block, and improve quality of labor epidural     analgesia/ anesthesia in obstetric population.   "
249294|NCT01119092|"     The purpose of this study is the examine the effects of gentle movements applied to the ankle     joint and stretching on self-reported function, ankle motion and stiffness in individuals who     have suffered from an ankle sprain within the last year and have decreased ankle motion.   "
249279|NCT01118897|"     SUMMARY      PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced     Gallbladder and Pancreatic cancers: A Phase II study      SPECIFIC OBJECTIVES:      Primary To assess the radiological response by dose escalated IMRT in locally advanced     inoperable gallbladder and pancreatic cancers.      Secondary        1. To assess the resectability rate with microscopic negative margin (R0).        2. To assess the acute and late toxicities (Number of Participants with Adverse Events as a          Measure of Safety and Tolerability)        3. To study the locoregional control in the patients undergoing R0 resection        4. To study overall survival      DESIGN: Phase II study      STUDY POPULATION: All patients of age >18 years years diagnosed with non metastatic locally     advanced inoperable gall bladder and pancreatic cancer      STUDY SIZE: 60 patients      METHODOLOGY: Sixty cases will be screened and taken for study if eligible after taking the     informed consent.      Patients will receive radiotherapy using Tomotherapy based IMRT with concurrent chemotherapy     Gemcitabine weekly. The response will evaluated at 6 weeks post chemoradiation and if     operable will undergo surgery, if still inoperable or metastatic will receive palliative     chemotherapy.      PROJECT PERIOD:      Total project period : 3 years Recruitment, Data collection : 2 years Complete analysis of     data : 1 year      STUDY SITE: Tata memorial centre   "
249280|NCT01118910|"     The purpose of this study is to determine if people with moist, red, patches on their skin in     body folds would benefit treatment of those areas with an FDA-approved drug called Vusion.   "
249281|NCT01118923|"     The present study is part of a project titled 'Magnesium in asthma and chronic obstructive     pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement     will benefit patients with asthma and chronic obstructive pulmonary disease.      The aim of this part of the project is to study the effect of a daily magnesium supplement on     the grade of bronchial hyperreactivity in asthmatics.   "
249282|NCT01118936|"     The present study is part of a project titled 'Magnesium in asthma and chronic obstructive     pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement     will benefit patients with asthma and chronic obstructive pulmonary disease.      The aim of this part of the project is to study the effect of a daily magnesium supplement     for COPD-patients   "
249283|NCT01118949|"     The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary     Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.   "
249284|NCT01118962|"     The purpose is to obtain data on the safety and seizure frequency associated with long-term     oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects     with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed     SP0961 (NCT01118949) to continue to receive Lacosamide.   "
249285|NCT01118975|"     This research is being done to find out how safe and how well the combination of lapatinib     and vorinostat works against advanced cancers.   "
249286|NCT01118988|"     This protocol matches child subjects with peer mentors of similar age who have learned to     function successfully with a chronic pain disorder. The trained mentors will present     information to the subjects in a supervised and monitored interaction via telephone and     computer for 2 months and encourage participation in skill-building programs. Children will     be tested for improvement in pain and functioning at 2 months and again at 4 months to see if     improvements persist. The investigators hypothesize that children who received peer mentor     support will show more improvement in pain and functioning at 2 and 4 months into treatment     than those in a control group who do not receive mentor support.   "
249287|NCT01119001|"     People with Amyotrophic Lateral Sclerosis (ALS) will use a P300 based brain computer     interface (BCI) keyboard to type in assistive technology devices. The results of this study     will be compared with a previous study of a P300 BCI keyboard used by healthy volunteers.   "
249288|NCT01119014|"     The benefits and harms of antipsychotics are relatively well studied in adults. However,     there is a lack of scientifically valid studies regarding the benefits and harms of     antipsychotics in children and adolescents with psychosis.      The main objective of the TEA trial is to compare the efficacy and adverse reactions of two     antipsychotics (quetiapine versus aripiprazole) in children and adolescents between 12-17     years of age with psychotic symptoms on psychopathology, cognitive deficits, and daily     functioning. Furthermore, the trial will focus on adverse reaction profiles of the two     antipsychotics as well as early predictors of later sustained clinical effects of these     antipsychotics.   "
249290|NCT01119040|"     The purpose of this study is to determine:        1. Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic          gastrostomy) PEG tube.        2. Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic          Surgery (NOTES) in lieu of traditional surgical methods.        3. Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical          methods.   "
249291|NCT01119053|"     In this monocentre two-armed double blind randomised placebo-controlled study - in which the     control group obtains the VNS therapy within a defined space of time after 12 weeks - the     impact of vagus nerve stimulation on depressive symptomatology of patients with     therapy-resistant depressive personality disorders shall be analysed. Particularly in     comorbid disorders, medicamentous treatment shows exceedingly bad response rates. Against the     background of hitherto insufficient treatment strategies for chronic or persistent depression     with comorbidities, the proceeding of a study on the effects of VNS on depressive patients     with comorbid disorders is absolutely essential.   "
249292|NCT01119066|"     The purpose of this study is to find out the effects of using a system called CliniMACS to     remove Tcells from blood stem cells. Removing T-cells may help stop a side effect called     Graft-Versus-Host Disease (GVHD). Some studies have been done with CliniMACS, but the Food     and Drug Administration (FDA) has not yet approved it.   "
249295|NCT01119105|"     This is a Phase II, multi-center, randomized, double-blind study comparing the safety and     efficacy of two doses of BC-3781 versus vancomycin in patients with acute bacterial skin and     skin structure infection.   "
249296|NCT01119118|"     The purpose of this research study is to assess the effects of ZD4054 on prostate cancer that     has spread to the bones by using new imaging techniques. In particular, this study will use     fluorodeoxyglucose (FDG) and 18F-Sodium Fluoride (NaF) PET/computed tomography (CT) and MRI     scans to look for changes in bone metastasis after ZD4054 therapy.   "
249298|NCT01119144|"     Hypothesis: Polycaprolactone / Tricalcium Phosphate Orbital (PCL / TCP) Implant is as     effective in the reconstruction of the Orbital walls as Titanium Mesh implant.      In this study we will be conducting a randomised trial to compare implants made of 2     materials for Orbital reconstruction        -  Polycaprolactone / Tricalcium Phosphate (PCL / TCP)        -  Titanium      Patients to be recruited :        -  80 randomised equally into the 2 groups        -  age range: 21 - 70        -  includes orbital wall defects from trauma, after osteotomies        -  excludes patients with Diabetes Mellitus, known allergies to polycaprolactone & its          analogues, know allergies to Tricalcium Phosphate & its analogues, infections          generalised & around the orbital region      Trial Duration: April 2010 - March 2015      Follow up:        -  postoperative 1 week, 1 month, 3 months, 6 months, and 12 months        -  Computer Tomographic (CT) scan of Orbits immediate postoperative and at 12 months          appointment   "
249299|NCT01119157|"     This is a randomized, single-blinded, Phase IV, monocentric study in healthy adults aged > 18     and < 60 years to evaluate the cellular and humoral immunogenicity as well as the     reactogenicity of intramuscular, inactivated, trivalent influenza vaccines, including     aluminium adjuvanted whole virus vaccine, split vaccine and subunit vaccine.   "
249300|NCT01119170|"     In this study the investigators want to test the safety of D-lactate producing probiotics in     babies from birth to 1 month of age. Previous data demonstrated no increase in urinary     D-lactate in 4 month old infants supplemented with D-lactate producing probiotics. The     primary purpose of this study is to evaluate the influence of D-lactate producing probiotics     on D-lactate excretion in young infants during the neonatal period (days 0 - 28).   "
249301|NCT01119183|"     Participants counseled with the preeclampsia educational tool will have a better     understanding of preeclampsia than those not counseled using the tool.   "
249302|NCT01119196|"     The goal of this study is to examine the relevance of insulin resistance in peritoneal     dialysis (PD) patients as well as the means to improve this metabolic derangement. We will do     so through a prospective randomized study using Icodextrin as an alternate dialysate solution     to routine glucose-based dialysate. We hypothesize that (1) the glucose loading associated     with PD leads to impairment in insulin sensitivity, (2) the degree of insulin resistance is     dependent on the basal metabolic state (fasting versus stimulated), and (3) the replacement     of conventional dialysate with glucose-sparing dialysate preparations will improve insulin     resistance and associated metabolic disturbances in PD patients.   "
249303|NCT01119209|"     Reducing pain is an essential factor for early mobilization after osteosynthesis of     intertrochanteric fractures. Systemic opioids have side effects that might obstruct     mobilization and induce delirium and nausea. The investigators hypothesized that wound     infiltration results in reduction in systemic opioid usage and pain relief without side     effects.   "
249312|NCT01119326|"     The purpose of this research study is to find out if it is safe and feasible to improve the     appearance and quality of a scar by using a procedure in which adipose tissue (fat) is taken     from other parts of your body and injected, or transplanted into a scar. This procedure is     called autologous fat transfer (AFT). The main goal of this study is to see if AFT is safe     and can improve the quality and appearance of scar tissue. Another main goal is to determine     how much tissue should be transplanted to get the best results.   "
249304|NCT01119222|"     Human experimental pain models are useful in understanding the mechanisms underlying clinical     pain conditions and can be used to test the analgesic efficacy of drugs used in the     management of pain. Once established these models can be used as mechanism biomarkers in     early development clinical studies to establish proof of mechanism for novel compounds. The     cold pain model is a mechanistic pain biomarker with potential application in proof of     mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research     Unit and demonstrate we can effectively screen subjects for this model and examine the effect     of morphine, diphenhydramine, and gabapentin in the cold pain model.   "
249305|NCT01119235|"     A new tablet form of PF-04531083 has been manufactured. Previously the compound was     administered as a solution/suspension to healthy volunteers. This study will investigate the     pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics     obtained, with the same dosing regimen, with the solution/suspension.   "
249306|NCT01119248|"     The number of children undergoing MRI imaging has increased significantly in the past years,     because many young children cannot stay still for the duration of the scan, have difficulty     tolerating the confined space and the noise produced by the Magnetic Resonance Imaging (MRI)     machine, sedation or General Anesthesia is required in these cases. In the investigators     institution, the investigators use General Anesthesia for children undergoing MRI.      Because children have a larger surface area to body weight ratio; hypothermia from passive     heat loss is one of the anesthesiologists' concerns.      MRI requires a cool environment with low humidity; this specialized environment represents a     significant thermal challenge to the anesthetized children. Since most temperature devices     are not compatible with the MRI, the simple task to measure temperature change has never been     investigated.   "
249319|NCT01119417|"     The purpose of this study is to test the hypothesis that endothelin plays a role in the     pathogenesis of supine hypertension in pure autonomic failure by increasing vascular     resistance. To gauge its contribution to blood pressure regulation, pure autonomic failure     and multiple system atrophy patients with supine hypertension will undergo a medication     testing with the endothelin blocker, BQ123. We will compare the hemodynamic effects between     PAF and MSA patients. Our primary endpoint will be the decrease in blood pressure during the     administration of this compound.   "
249320|NCT01119430|"     The purpose of this study is to examine whether the speed of the clinical antidepressant     action of fluoxetine can be accelerated by administering DU125530 a full 5-HT1A antagonist.   "
249321|NCT01119443|"     Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d.     under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.   "
249322|NCT01119456|"     A dose escalation study to determine the maximum tolerated dose of IMC-RON8 in patients with     solid tumor. Patients can either be dosed once a week, or once every other week.   "
249323|NCT01119469|"     This study will compare the efficacy of cognitive therapy and exposure therapy for treating     hypochondriasis.   "
249307|NCT01119261|"     Rationale:      The narrow therapeutic range and wide inter-patient variability in dose requirement make     anticoagulation response to coumarin derivatives unpredictable. As a result, patients require     frequent monitoring to avert adverse effects and maintain therapeutic efficacy. Polymorphisms     in cytochrome P450 2C9 (CYP2C9) and vitamin K epoxide reductase complex 1 (VKORC1) jointly     account for about 40% of the inter-individual variability in dose requirements. To date,     several pharmacogenetic guided dosing algorithms for coumarin derivatives, predominately for     warfarin, have been developed. However, the potential benefit of these dosing algorithms in     terms of their safety and clinical utility has not been adequately investigated in randomised     settings. Objective: To determine whether a dosing algorithm containing genetic information     increases the time within therapeutic INR range during anticoagulation therapy with each of     warfarin, acenocoumarol and phenprocoumon compared to a dosing regimen that does not contain     this information. Secondary outcomes of the study include cost effectiveness, number of     thromboembolic and bleeding events, time to reach stable dose and number of supratherapeutic     INR peaks. Study design: This is a two-armed, single-blinded, randomised controlled trial. In     one arm (intervention) patients commencing anticoagulation therapy with either warfarin,     acenocoumarol or phenprocoumon will be dosed according to a drug-specific genotype-guided     dosing algorithm, which is based on genetic information, clinical data and (in the monitoring     phase) previous INR. For the other arm (control) patients will be dosed according to a     non-genotype-guided dosing regimen which does not include genetic information. The follow-up     period per patient is 3 months. Study population: Newly diagnosed patients of both genders     and at least 18 years old who need anticoagulant treatment with either acenocoumarol,     phenprocoumon or warfarin within the low intensity INR range will be included in the trial.     Main study parameters/endpoints: The % time within therapeutic INR range in the first 3     months of anticoagulation therapy. Nature and extent of the burden and risks associated with     participation, benefit and group relatedness: Six extra blood samples are taken from each     participant at the start of the study. Patients also have to attend 8 scheduled visits within     the 3 months study period and are asked to fill in questionnaires. The genotype-guided dosing     algorithm is anticipated to improve the accuracy of coumarin dosing and thus improve the     safety and efficacy of anticoagulation therapy.   "
249308|NCT01119274|"     Rationale:      The narrow therapeutic range and wide inter-patient variability in dose requirement make     anticoagulation response to coumarin derivatives unpredictable. As a result, patients require     frequent monitoring to avert adverse effects and maintain therapeutic efficacy. Polymorphisms     in cytochrome P450 2C9 (CYP2C9) and vitamin K epoxide reductase complex 1 (VKORC1) jointly     account for about 40% of the inter-individual variability in dose requirements. To date,     several pharmacogenetic guided dosing algorithms for coumarin derivatives, predominately for     warfarin, have been developed. However, the potential benefit of these dosing algorithms in     terms of their safety and clinical utility has not been adequately investigated in randomised     settings.      Objective:      To determine whether a dosing algorithm containing genetic information increases the time     within therapeutic INR range during anticoagulation therapy with each of warfarin,     acenocoumarol and phenprocoumon compared to a dosing regimen that does not contain this     information. Secondary outcomes of the study include cost effectiveness, number of     thromboembolic and bleeding events, time to reach stable dose and number of supratherapeutic     INR peaks.      Study design:      This is a two-armed, single-blinded, randomised controlled trial. In one arm (intervention)     patients commencing anticoagulation therapy with either warfarin, acenocoumarol or     phenprocoumon will be dosed according to a drug-specific genotype-guided dosing algorithm,     which is based on genetic information, clinical data and (in the monitoring phase) previous     INR. For the other arm (control) patients will be dosed according to a non-genotype-guided     dosing regimen which does not include genetic information. The follow-up period per patient     is 3 months.      Study population:      Newly diagnosed patients of both genders and at least 18 years old who need anticoagulant     treatment with either acenocoumarol, phenprocoumon or warfarin within the low intensity INR     range will be included in the trial. Main study parameters/endpoints: The % time within     therapeutic INR range in the first 3 months of anticoagulation therapy. Nature and extent of     the burden and risks associated with participation, benefit and group relatedness: Six extra     blood samples are taken from each participant at the start of the study. Patients also have     to attend 8 scheduled visits within the 3 months study period and are asked to fill in     questionnaires. The genotype-guided dosing algorithm is anticipated to improve the accuracy     of coumarin dosing and thus improve the safety and efficacy of anticoagulation therapy.   "
249309|NCT01119287|"     The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to     placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels     in an Environmental Exposure Chamber (EEC).   "
249310|NCT01119300|"     Rationale:      The narrow therapeutic range and wide inter-patient variability in dose requirement make     anticoagulation response to coumarin derivatives unpredictable. As a result, patients require     frequent monitoring to avert adverse effects and maintain therapeutic efficacy. Polymorphisms     in cytochrome P450 2C9 (CYP2C9) and vitamin K epoxide reductase complex 1 (VKORC1) jointly     account for about 40% of the inter-individual variability in dose requirements. To date,     several pharmacogenetic guided dosing algorithms for coumarin derivatives, predominately for     warfarin, have been developed. However, the potential benefit of these dosing algorithms in     terms of their safety and clinical utility has not been adequately investigated in randomised     settings. Objective:      To determine whether a dosing algorithm containing genetic information increases the time     within therapeutic INR range during anticoagulation therapy with each of warfarin,     acenocoumarol and phenprocoumon compared to a dosing regimen that does not contain this     information. Secondary outcomes of the study include cost effectiveness, number of     thromboembolic and bleeding events, time to reach stable dose and number of supratherapeutic     INR peaks.   "
249311|NCT01119313|"     The aim of the study is an intra-individual comparison of skin conditions in addition to a     patient based assessment of product appearance in the topical treatment of atopic eczema.   "
249313|NCT01119339|"     The aim of the study is to intra-individually compare the dose-related efficacy of LAS41004     in a Psoriasis Plaque Test (PPT)   "
249314|NCT01119352|"     The aim of the study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of AZD7687 following multiple ascending dose administrations in in     overweight to obese but otherwise healthy male subjects   "
249316|NCT01119378|"     The purpose of this study is to determine the capability to absorb calcium as a measure of     the sufficient levels of Vitamin D. Calcium absorption will be measured at baseline and after     vitamin D3, by dual calcium isotope technique using stable isotopes in post menopausal women     between the ages 50 and 70yrs. Subjects will have a screening visit, first and final visits.     Subjects will be randomly assigned to a placebo or daily doses of vitamin D3. The specific     aim of this study is to determine the level of vitamin D that will maximize the absorption of     calcium and establish the relationship between the administered calcium dose and the actual     absorbed calcium dose versus administered dose of Vitamin D and the serum levels of Vitamin     D.   "
249317|NCT01119391|"     Many women undergoing in vitro fertilization (IVF) ask their doctor if there are any     behaviors they should avoid, or any behaviors they should emphasize during their IVF cycle.     This study examines the effects of health habits surrounding exercise, smoking, alcohol,     sleep, caffeine, herbal medications, acupuncture, and diet on pregnancy rates during IVF     cycles. The purpose of this study is to determine if lifestyle behaviors have a significant     impact on pregnancy rates during treatment with IVF.      This is an observational study conducted at a private academically-affiliated infertility     clinic and includes 118 women ages 44 and below scheduled to undergo IVF treatment. All     subjects were asked to complete a health history survey at the time of enrollment and a daily     survey during each day of their IVF cycle. The primary outcome is clinical pregnancy rate.   "
249336|NCT01119651|"     The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a     photoallergic reaction when exposed to UV and VIS light on skin of healthy volunteers.   "
249324|NCT01119482|"     Meningococcal disease occurs throughout the world but attack rates in the Sahelian and     sub-Sahelian regions of Africa - the African meningitis belt - are many times higher than     those seen in any other part of the world. During 2009, over 70,000 meningitis cases and     3,200 deaths were reported in Nigeria, Niger, and Chad alone.      In 2001, a public private partnership between WHO and PATH was created, the Meningitis     Vaccine Project (MVP). The MVP set out to develop an affordable meningococcal serogroup A     conjugate vaccine (MenAfriVac™) for use in the African meningitis belt. This was successfully     achieved, and the new vaccine, produced by the Serum Institute of India (SII), was granted a     licence in 2009 for international export. The vaccine dossier was submitted to WHO for     prequalification at the beginning of 2010. Introduction through mass vaccination is planned     in three African Meningitis belt countries in 2010 (Burkina Faso, Mali and Niger). The     implementation of MenAfriVac will be the responsibility of the local Ministry of Health, with     the support of the World Health Organization.      It is anticipated that this vaccine will be deployed in other countries of the meningitis     belt in 2011. This vaccine should provide high levels of direct protection to immunised     individuals but, as for serogroup C conjugate vaccines in the United Kingdom, a greater     public health impact will be achieved if carriage and transmission of the infection are also     prevented.      The London School of Hygiene & Tropical Medicine (LSTHM) is coordinating the African     Meningococcal Carriage Consortium (MenAfriCar). One of the primary objectives of the     MenAfriCar project is to evaluate the impact of the new conjugate vaccine on meningococcal     carriage and transmission of serogroup A meningococci in Mali, Niger and Chad. A     community-based prospective, pre- and post intervention, observational study will be     conducted. MenAfriCar will also help to develop research capacity in the participating     African countries.   "
249325|NCT01119508|"     The goal of this clinical research study is to learn if combining ipilimumab and temozolomide     can help to control metastatic melanoma. The safety of this drug combination will be studied.     Researchers would also like to study how this therapy affects the levels of certain chemicals     in the blood that are related to your immune system.   "
249326|NCT01119521|"     The purpose of this research is to further study the tuberculosis (TB) vaccine, Bacillus     Calmette Guérin (BCG). The goal of this study is to evaluate whether the BCG vaccine is more     effective in preventing TB in adults if it is given after 6 months of treatment with a widely     used anti-TB drug, isoniazid (INH). Participants will include 82 healthy, tuberculin skin     test positive (TST+), HIV-uninfected, male and female volunteers, aged 18-40 years. The study     will be conducted in Worcester, South Africa. Subjects will be assigned by chance to 1 of 2     possible treatment groups. Group 1 will receive 6 months of oral INH treatment followed by     intradermal (administered into the skin) BCG revaccination and one year of follow-up. Group 2     will be observed for 7 months which will be followed by intradermal BCG revaccination and     another 6 months of follow-up. Then 6 months of INH treatment will be given. Participants     will be involved in study procedures for about to 22 months.   "
249327|NCT01119534|"     It is believed that the suppository consisting of guaiacol, menthol, camphor and eucalyptol,     by their pharmacological properties already established for each component, has the ability     to reduce the signs and symptoms related to upper respiratory infections in a manner     equivalent (not inferior) to medicine used as a comparator in this study and higher than the     suppository containing only guaiacol concentration of 12.5 mg.   "
249328|NCT01119547|"     The purpose of this study is to investigate if inclusion of exercise in an education program     for patients with osteoarthritis can improve self efficacy, self-perceived health and     function.   "
249329|NCT01119560|"     This research trial studies the genes biomarkers in children with neuroblastoma. Studying the     genes in a child's cancer cells may help doctors improve ways to diagnose and treat children     with neuroblastoma.   "
249349|NCT01119820|"     Analyze human skeletal muscle and learn more about the ability of adult muscle to produce     myoblasts (young muscle cells).   "
249331|NCT01119586|"     RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in DNA samples from patients with newly     diagnosed high-risk acute lymphoblastic leukemia.   "
249332|NCT01119599|"     This phase I trial studies the side effects and best dose of gamma-secretase/Notch signalling     pathway inhibitor RO4929097 (RO4929097) when given together with temozolomide and radiation     therapy in treating patients with newly diagnosed malignant glioma. Enzyme inhibitors, such     as gamma-secretase/Notch signalling pathway inhibitor RO4929097, may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as temozolomide, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gamma-secretase/Notch     signalling pathway inhibitor RO4929097 together with temozolomide and radiation therapy may     kill more tumor cells.   "
249333|NCT01119612|"     The purpose of this study is to determine safety and efficacy of prenatal iron     supplementation in an area of high malaria burden among women who are not anemic or iron     deficient.   "
249334|NCT01119625|"     This primary purpose of this study is the evaluation of the immunological persistence     following completion of the 3-dose primary vaccination course with either a clinical or a     commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In     addition, the study will also assess the safety, reactogenicity and immunogenicity of a     fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when     co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study     NCT00808444.      The primary vaccination study was conducted in Malaysia and Singapore. The booster     vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine     GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be     offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia     and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally     recommended regimen. Administration of the booster dose will be outside the set-up of a     clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.   "
249335|NCT01119638|"     Behavioral and psychological symptoms of dementia (BPSD) are among the most distressing     manifestations of dementia. Pharmacotherapy is frequently used and especially in     institutional settings. Current guidelines recommend the use of second-generation     antipsychotics (SGAs). Nonetheless, there are concerns regarding both their safety and     effectiveness in patients with dementia. Inconclusive evidence support the use of other     psychoactive agents such as SSRI antidepressants or cognitive enhancers.      In two published studies citalopram was as efficacious as, but better tolerated than     perphenazine or risperidone in patients with BPSD.      Thus, with proven efficacy and a beneficial safety profile the evaluation of the use of     escitalopram for BPSD is warranted.   "
249337|NCT01119664|"     The purpose of this study is to find the safety of combination gene therapy and chemotherapy     in patients with malignant pleural mesothelioma. Pleural catheter will be placed first, then     pts will receive 2 doses of intrapleural vector followed by front line or second line     chemotherapy 4-6 cycles every 21 days.   "
249338|NCT01119677|"     This is a randomized, 3-arm, dose-blinded, parallel-group study. Subjects will be randomized     to one of 3 treatment titration regimes (slow titration over 6 weeks, fast titration over 3     weeks, and no titration).   "
249339|NCT01119690|"     In this study, the effects of dietary intake of cold-pressed turnip rapeseed oil (CTPRO) and     milk fat are compared in men with metabolic syndrome having already participated in HMS-02     study.   "
249340|NCT01119703|"     This study evaluated whether it is possible in healthy elderly participants to generate     baseline biomarker-based prediction rules (PdR) for vaccine response (post baseline absolute     serum antibody titer) using each of the protocol selected vaccines separately; and examined     the rank correlation coefficients of pairs of post vaccination antibody titers within the     same elderly individuals.   "
249341|NCT01119716|"     This study will create a prospective registry of consecutive patients with Atrial     Fibrillation (Afib) considered for cardioversion treatment to document up-to-date practice of     in-hospital treatment, with a focus on the characterization of type of Afib, as well as on     treatments applied (drugs, devices, interventions and their combinations), and associated     complications within 60 days after enrollment.   "
249342|NCT01119729|"     Human immunodeficiency virus (HIV) infection has been associated with a variety of     cardiovascular diseases. Even most industrialised countries exhibit a growing and aging     population of HIV-infected patients in the majority treated with antiretroviral drugs, the     investigators still do not know much about the impact of cardiovascular diseases in this     group of patients. The present study is an ongoing trial that was conducted as a prospective     and multicentre survey, being schemed to analyse the frequency and clinical course of cardiac     disorders in HIV-infected patients.   "
249343|NCT01119742|"     To demonstrate comparable safety and efficacy of Taro Pharmaceuticals, Inc butenafine     hydrochloride cream 1% test product and Lotrimin Ultra cream (reference listed drug) in the     treatment of interdigital tinea pedis, and to show the superiority of the active treatments     over that of the placebo (vehicle).   "
249344|NCT01119755|"     This is a prospective study to evaluate the change in 24 hour ambulatory blood pressure     during winter and summer in well controlled treated hypertensives.   "
249345|NCT01119768|"     To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and     2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis     patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.   "
249346|NCT01119781|"     The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose     of PEGylated Interferon Beta-1a (BIIB017) administered subcutaneous in participants with     renal impairment and in participants with normal renal function (healthy participants). A     secondary objective of this study in this study population is to evaluate the safety and     tolerability of a single dose of PEGylated Interferon Beta-1a administered subcutaneous.   "
249350|NCT01119833|"     GMI-1070 is a new drug that may reduce the stickiness of cells in the blood. The purpose of     this study is to evaluate whether GMI-1070 can reduce the time it takes for pain to go away     in patients with vaso-occlusive crisis (also known as a sickle cell pain crisis). The study     will also collect information on the safety of GMI-1070, how much of the drug is in the blood     and urine, and if there are any other effects when used in patients who are in the hospital     for a sickle cell pain crisis.   "
249351|NCT01119846|"     The purpose of this study is to see if GSK1292263 is safe and well-tolerated when     administered to type 2 diabetics, and to get preliminary information about whether it may be     effective in the treatment of type 2 diabetes.   "
249352|NCT01119859|"     This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab     (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis     who are intolerant of methotrexate or where continued treatment with methotrexate was     considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg     intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or     adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to     last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of     the treatment administration, but the investigator and the patient remained blinded.   "
249353|NCT01119872|"     Randomized controlled pilot trial in 70 patients with Acute Respiratory Distress Syndrome     (ARDS) ventilated with low tidal volumes and limitation on airway pressure at 35 centimeters     of water (cmH2O), to compare two different methods of selecting the level of Positive     End-Expiratory Pressure (PEEP) to be applied: according to fraction of inspired oxygen (FiO2)     needed or individualized according to the best compliance. Primary objective was evolution of     arterial oxygenation during the 28 days. Secondary objectives were to measure its effects on     hemodynamic parameters, 28-day mortality, number of ventilator-free days at day 28, Intensive     Care Unit (ICU) and hospital stay, number of multiple-organ dysfunction-free days and a     multivariate analysis of 28 day-mortality.   "
249354|NCT01119885|"     The purpose of this study is to investigate the utility of fentanyl matrix for the treatment     of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by     non-opioid analgesic (e.g. NSAIDs or COX-II inhibitors) or weak opioids [tramadol     HClacetaminophen, tramadol or codeine (or combinations with acetaminophen/ibuprofen)].   "
249355|NCT01119898|"     Osteoarthritis (OA) is the most common form of arthritis and can cause pain, swelling, and     reduced motion in the joints, which as a result can impact quality of life. It can occur in     any joint, but usually affects the hands, knees, hips or spine. The purpose of this study is     to determine the efficacy and safety of a topical nonsteroidal anti-inflammatory drug (NSAID)     gel formulation in the treatment of osteoarthritis of the knee.   "
249356|NCT01119911|"     We hypothesize that peripheral venous catheter used for fluid administration can replace     venipuncture blood sampling for selected basic analytes and thus reduce pain in infants under     2 years of age.   "
249358|NCT01119937|"     This is a 52-week, multi-center, randomized, open label, parallel group study to assess the     long term safety and tolerability of once-daily NVA237, using tiotropium as an active     control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease     (COPD) .   "
249359|NCT01119950|"     This study was designed to investigate the efficacy and safety of NVA237, a long-acting     muscarinic antagonist, in patients with moderate to severe COPD.   "
249360|NCT01119963|"     The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone     caproate (17P, Makena®) given to women with preterm rupture of the membranes will:        1. increase the probability of continuing the pregnancy until a favorable gestational age.        2. increase the interval between randomization and delivery.        3. decrease neonatal morbidity.   "
249361|NCT01119976|"     This is a research study to look at the association between weight loss and the menstrual     cycle in healthy, overweight, premenopausal women. Participants will be asked to follow a     reduced-calorie diet and exercise plan for 3 months.   "
249362|NCT01119989|"     10 healthy male volunteers will be studied after        -  a 6 day weight maintenance, balanced diet        -  a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body          weight/day        -  a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body          weight/day and 20g amino-acids per day At the end of each 6 days period, the following          measurements will be obtained        -  intrahepatic lipids (1H-MRS)        -  metabolic effects of fructose ingestion (measurement of substrate oxidation,          gluconeogenesis from fructose, palmitate synthesis from fructose, plasma VLDL-kinetics)      This is a randomized, double blinded study   "
249363|NCT01120002|"     A double blind, placebo-controlled randomized study to evaluate the efficacy and safety of     orally administered Tamibarotene to patients of Alzheimer's Disease   "
249364|NCT01120015|"     The purpose of this study is to evaluate clinical effectiveness of diacerein as add on     therapy to diclofenac sodium in Indian patients of osteoarthritis (OA) knee.   "
249365|NCT01120028|"     The 3C study will investigate whether reducing exposure to calcineurin inhibitors (by using     more potent antibody induction treatment and/or an elective switch to sirolimus) can improve     the function and survival of kidney transplants.   "
249366|NCT01120041|"     The purpose of this study is to determine whether giving brief motivational interviewing     counseling during the prenatal and/or postnatal period(s) will increase utilization of     preventive dental care and improve the oral health of rural, low-income pregnant and     postpartum women and their children, and to increase the number of home oral health practices     taken by these women to prevent caries in their young children.   "
249367|NCT01120054|"     Objectives include: 1) establishing a psychometrically sound traumatic brain injury (TBI)     screening measure for use among homeless veterans; 2) identifying the prevalence of those     that screen positive for TBI among homeless veterans seeking VA services; and 3) comparing     psychiatric and psychosocial outcomes between those with and without a history of TBI.   "
249369|NCT01120080|"     The goal of this study is to train phone counselors working for the New York (NY) State     Smokers' Quitline to advise callers who drink at hazardous levels to limit or abstain from     alcohol use to determine whether this improves smoking cessation outcomes so that we can     establish effect size estimates for a full scale multi-site trial.   "
249370|NCT01120093|"     The present trial is conducted to further assess the efficacy by means of serial spirometry,     safety and tolerability of three doses of aclidinium bromide administered twice a day     compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with     moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment.     Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between     them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a     follow up contact 14-days after last treatment dose.   "
249371|NCT01120106|"     Calcium sensitizer drugs such as Levosimendan may exert anti-ischemic effect in addition to     positive inotropic and anti-stunning effects mediated by the opening of ATP-sensitive     potassium (KATP) channels. The aim of the study is to test the myocardial protection effect     of peri-operative iv infusion of Levosimendan in a cohort of neonates affected by     transposition of the great arteries undergoing surgical correction by arterial switch.   "
249372|NCT01120119|"     Reduction in vitamin D levels has been reported in subjects with recent onset type 1     diabetes. Several studies suggest that vitamin D supplementation in early childhood decreases     the risk of developing type 1 diabetes, therefore vitamin D deficiency might play a role in     the disease pathogenesis. We investigated whether the supplementation of the active form of     vitamin D (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual     beta cell function evaluated by C peptide and improve glycaemic control as evaluated by HbA1c     and insulin requirement.      Thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1     diabetes (<12 weeks duration) and high basal C-peptide >0.25 nmol/l were randomized in a     double-blind trial to calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3     [1,25-(OH)2D3] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.   "
249373|NCT01120132|"     The purpose of this study is to determine the efficacy and safety of the administration of     cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic     conjunctivitis.   "
249374|NCT01120145|"     The purpose of this study is to determine the efficacy and effectiveness of     sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy for reducing     malaria-associated morbidity in pregnant women in Malawi.   "
249375|NCT01120158|"     This study will evaluate the efficacy, safety and effect on quality of life of weekly     paclitaxel plus bevacizumab as first line treatment in elderly patients (≥ 70 years old) with     metastatic breast cancer. Furthermore, the efficacy of the combination therapy will be     correlated with the functional status of patients according to the comprehensive geriatric     assessment.   "
249376|NCT01120171|"     This study will evaluate the efficacy, safety and effect on quality of life of     liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second     line treatment of older patients (≥ 70 years old) with metastatic breast cancer. The efficacy     of the combination will be correlated with the functional status of patients according to the     comprehensive geriatric assessment   "
249377|NCT01120184|"     This randomized, 3-arm, multicentre, phase III study will evaluate the efficacy and safety of     trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with     pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab     (Herceptin) plus taxane (docetaxel or paclitaxel) in patients with HER2-positive progressive     or recurrent locally advanced or previously untreated metastatic breast cancer. Patients will     be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas     Arms B and C will be blinded.   "
249378|NCT01120197|"     The aim of this randomized controlled trial is to evaluate the effectiveness for     health-related quality of life (HRQOL) of a 3-month course of exercises for a group of     postmenopausal women with osteoporosis who has at least one vertebral fracture versus a     control group (undertaking their usual activities). The course of exercises is devised in     accordance with methods recommended in Rehabilitation treatment guidelines in postmenopausal     and senile osteoporosis.   "
249379|NCT01120210|"     The purpose of this study is to investigate the safety, tolerability, pharmacodynamics (how     the study medication affects the body) and pharmacokinetics (how the drug is absorbed in the     body, how it is distributed within the body and removed from the body over time) of an     intravenous administration of JNJ-39588146 or placebo over a 3-hour period in patients with     heart failure. The highest tolerated dose received during the first 3 hours of the study will     be administered to some patients for an additional 18 hours. There will be up to 3 doses     given throughout the administration period over a total of up to 21 hours.   "
249380|NCT01120223|"     The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO     80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has     marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp®     Topical Suspension for the treatment of scalp psoriasis in adults. No studies have been     performed in subjects younger than 18 years   "
249381|NCT01120236|"     This randomized phase II trial is studying bicalutamide, goserelin, or leuprolide acetate to     see how well they work when given with or without cixutumumab in treating patients with newly     diagnosed metastatic prostate cancer. Androgens can cause the growth of prostate cancer     cells. Antihormone therapy, such as bicalutamide, goserelin, or leuprolide acetate, may     lessen the amount of androgens made by the body. Monoclonal antibodies, such as cixutumumab,     can block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     It is not yet known whether bicalutamide, goserelin, or leuprolide acetate are more effective     when given with or without cixutumumab in treating prostate cancer.   "
249382|NCT01120249|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth or by blocking blood flow to the tumor.      PURPOSE: This phase III trial is studying everolimus to see how well it works in treating     patients with kidney cancer who have undergone surgery.   "
249383|NCT01120262|"     RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research study is studying blood samples from patients with metastatic prostate     cancer previously treated with bicalutamide and goserelin.   "
249384|NCT01120275|"     This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor     RO4929097 works in treating patients with stage IV melanoma. Gamma-secretase/Notch signalling     pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
249385|NCT01120288|"     Background:      - A protein called HIF is believed to be involved both in forming cancers and helping them to     grow after they are formed. EZN-2968 is a new type of cancer drug that goes into the cancer     cell and switches off the production of the HIF protein. Researchers are interested in     testing EZN-2968 in people who have liver cancer because studies have shown that this drug     travels to the liver and stays there when the drug is given through a vein.      Objectives:      - To determine the safety and effectiveness of EZN-2968 on liver cancer.      Eligibility:      - Individuals 18 years of age and older who have been diagnosed with liver cancer that has     not responded to standard treatments.      Design:        -  Participants will have an initial screening visit with a physical examination, blood and          urine tests, and imaging studies to assess tumor size. Tumor biopsies may also be taken          for research purposes.        -  Participants will have an undefined number of 6-week treatment cycles of EZN-2968, given          once a week for 3 weeks followed by 3 weeks without the drug.        -  During each cycle, participants will have additional blood tests and imaging scans to          assess tumor response to treatment.        -  Cycles of treatment with EZN-2968 may continue until the treatment is not effective,          illness requires participants to stop taking the study drug, or the participant chooses          to withdraw from the study.   "
249386|NCT01120301|"     The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser     therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with     acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject     between 4.5 and 24 hours of stroke onset.   "
249387|NCT01120314|"     Primary Objective:        -  To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of          Otamixaban.      Secondary Objective:        -  To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and          severe renal impairment and in matched subjects with normal renal function.   "
249388|NCT01120327|"     1. OBJECTIVES           Primary objective to evaluate the difference of the peak oxygen uptake change (VO2 max,          mL/kg/min) in amlodipine group against no CCB group at 9 months           Secondary objectives To evaluate the change of sublingual nitrate use per day against no          CCB group at 1 and 3 months To evaluate the change of biomarkers against no CCB group at          9 months        2. SUBJECTS AND CENTERS 212, stable angina patients with angiographically confirmed          significant residual stenosis 10, 3rd-grade, teaching hospitals in Korea   "
249406|NCT01120561|"     This is a multicenter, open-label, single-arm, expanded access study designed to provide     T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to     evaluate the safety and efficacy of T-DM1 administered by intravenous (IV) infusion.   "
249389|NCT01120340|"     The purpose of this study is to determine whether mesalamine is effective vs. placebo in the     prevention of diverticulitis flares in a 24-months follow-up.      The primary end-point of the study is the incidence of diverticulitis flares. Will be made a     clinical diagnosis of uncomplicated diverticulitis: fever, leukocytosis, abdominal pain and     altered intestinal motility.   "
249390|NCT01120353|"     The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of cancer     and its associated therapies. A retrospective cohort study will be conducted through a     multi-institutional collaboration, which will involve the identification and active follow-up     of a cohort of approximately 50,000 survivors of cancer, diagnosed before 21 years of age,     between 1970 and 1999 and 10,000 sibling controls. This project will study children and young     adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or     surgery, who are at increased risk of late-occurring adverse health outcomes. A group of     sibling controls will be identified and data collected for comparison purposes.   "
249391|NCT01120366|"     The objective of this study is to investigate the efficacy and safety of the humanized     anti-human IL-6 receptor monoclonal antibody tocilizumab (TCZ) either in monotherapy or in     combination therapy with methotrexate (MTX) in patients with an inadequate response to     treatment with MTX.      Furthermore, in patients who have been able to achieve control of disease activity via the     above therapy, we investigate the possibility of stopping TCZ and verify safety when TCZ is     restarted after disease recurrence.   "
249392|NCT01120379|"     XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives     of this study are        -  To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in          real world settings, and        -  To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT)          initiative. This initiative is designed to evaluate the composite of all death,          myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free          from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and          that have been treated with drug eluting stents (DES) and extended dual antiplatelet          therapy.   "
249393|NCT01120392|"     Treatment with Nintendo wii is higher to physical therapy conventional in the quality of life     and motor performance in patients with Parkinson's disease.   "
249394|NCT01120405|"     The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial     necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon     based general anesthesia procedure in patients with elevated cardiac risk scheduled for     atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when     compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.   "
249395|NCT01120418|"     The objective of this study is to evaluate the effect on corneal endothelial cell density     changes when ISV-403 is administered for five (5) days compared to no drug treatment, in     healthy subjects.   "
249396|NCT01120431|"     The purpose is to evaluate the safety and efficacy as well as the time and resources needed     in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate     dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.   "
249398|NCT01120457|"     The purpose of this study is to assess the safety and tolerability of BMS-936564 (MDX-1338)     in relapsed Acute myelogenous leukemia (AML) and other selected B-cell cancers and to     determine the maximum tolerated dose (MTD) of the drug alone in relapsed/refractory AML   "
249399|NCT01120470|"     This study is being offered to patients who have castrate-resistant (also known as     hormone-refractory) prostate cancer. The cancer has metastasized or spread outside the     prostate area to other parts of the body or has recurred in the pelvic area after treatment.      The purpose of this clinical research study is to determine whether OGX-427 is able to slow     the progression of prostate cancer and symptoms of disease when given with prednisone better     than when prednisone is given alone in patients with prostate cancer whose disease has spread     outside the prostate area.      Research Hypothesis:      That adding OGX-427 to prednisone treatment will produce a progression free rate of 20%.   "
249400|NCT01120483|"     Malnutrition is a common phenomenon in cancer patients. Deteriorated nutritional status is     associated with poor clinical outcome. The purpose of this study is to determine the     prevalence of hospital malnutrition and its impact on functionality, quality of life and     mortality in cancer patients and to test the reference percentiles of phase angle values     (Bosy Westphal et al JPEN 2006) as indicator of cancer cachexia and predictor of mortality.      Hypothesis:      The fifth reference percentile of the phase angle norm values is a prognostically relevant     cut off value indicating cancer cachexia in terms of malnutrition, fatigue and impaired     functional status, as well as predictive of 6-month mortality   "
249401|NCT01120496|"     The purpose of this study is planned to investigate whether frequently inhaled hypertonic     saline (HS) can relieve symptoms and signs faster than normal saline (NS) and shorten length     of stay (LOS) significantly for moderately to severely ill infants with bronchiolitis without     apparent adverse effects.   "
249402|NCT01120509|"     The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and     effective in preventing pulmonary embolism.   "
249403|NCT01120522|"     The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and     effective in preventing pulmonary embolism.   "
249404|NCT01120535|"     The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and     effective in preventing pulmonary embolism.   "
249405|NCT01120548|"     Sleep disordered breathing (SDB) is a frequent comorbidity for heart failure patients. Its     prevalence varies according to the seriousness of the condition of the patients, but it is     present in approximately 50% of patients. Screening patients for SDB and managing them by     providing adapted ventilation therapy should improve their quality of life or even their     prognosis. Moreover, SDB lowers nocturnal cardiovascular recovery abilities and leads to an     increase in fatigability and, as a result, exercise intolerance in patients with heart     failure. Physical training as part of a cardiac rehabilitation programme provides many     benefits, including improving patients' exercise capacities. Our hypothesis is that adapted     sleep disordered breathing therapy during rehabilitation will lead to an improvement in     rehabilitation results.   "
249407|NCT01120574|"     The objective of this study is to evaluate the clinical benefits of home mechanical     ventilation associated to oxygen therapy in COPD patients with chronic respiratory failure     (CRF) who develop hypercapnia and nocturnal respiratory acidosis secondary to oxygen     administration.      We will include clinically stable COPD patients with hypercapnic CRF who develop a nocturnal     hypercapnic response to oxygen (PaCO2 increase on awakening, at night with oxygen, >10 mmHg     respect to PaCO2 breathing room air and awake). Obstructive sleep apnoea syndrome (OSAS) will     previously have been excluded.      Patients will be admitted to the Pneumology ward where a nocturnal pulsioxymetry breathing     oxygen therapy will be performed. Arterial blood gas samples will be taken at awakening     (7AM).      Patients who develop a hypercapnic response to oxygen will be randomised into 2 treatment     groups:        -  Oxygen therapy group        -  Home mechanical ventilation plus oxygen therapy group Home mechanical ventilation will          be performed with a bilevel pressure ventilator. Functional respiratory variables as          well as quality of life and sleep at onset and after 6 months treatment will be          compared.      The principal outcome will be the evolution of arterial blood gases (PaCO2) between the two     groups.   "
249408|NCT01120587|"     This study has as objective to characterize the start of pharyngeal phase of swallowing, in     the various food consistencies and volumes, with and without the influence of verbal orders,     observed on videofluoroscopy of deglutition.   "
249409|NCT01120600|"     The purpose of this study is to test the hypothesis that treatment with odanacatib will     result in increased BMD (bone mineral density) compared to treatment with placebo. This study     will also evaluate the safety and efficacy of odanacatib for male osteoporosis patients.   "
249410|NCT01120613|"     Hypertension (HTN) affects up to 75% of kidney transplant recipients and is associated with     premature death. Nocturnal HTN is a common complication of ongoing essential HTN or a     secondary cause of HTN. Both the non dipping of systolic blood pressure (SBP) at night time     and the reverse dipping is associated with increased target organ damage and adverse     cardiovascular outcomes and possibly allograft survival. Treatment of Nocturnal HTN is     critical. Chronotherapy has been shown to be effective in halting progression in patients     with diabetic nephropathy and chronic kidney disease. There is not enough data on prevalence     and management of nocturnal HTN in transplant patients, which is the object of this study.   "
249411|NCT01120626|"     Fragile X syndrome (FraX) is the most common known heritable cause of human intellectual     disability. Though recent research has revealed much about the genetic and neurobiological     bases of FraX, knowledge about specific and effective treatments for affected individuals is     lacking. Based on information from both human and animal studies, one cause of intellectual     disability in FraX may be related to deficits in a particular brain neurotransmitter system     (the cholinergic system). Thus, the investigators propose to use a specific medication,     donepezil, to augment cholinergic system in adolescents affected by FraX. If found to be     effective, the knowledge generated by this research may also be relevant to other     developmental disorders that share common disease pathways with FraX.   "
249414|NCT01120665|"     This study will investigate the isolated and the associated effect of estrogen therapy and     physical exercise in the function, regulation and cardiovascular risk markers of 60     postmenopausal women, (45 - 60 years old). The volunteers will be randomaized into two     groups: estrogen therapy (estradiol valerate 1 mg/day oraly) and placebo. The two groups will     be randomaized into two subgroups: exercise group (aerobic trainning,cicle-ergometre, 50     minutes, 3 x week) and sedentary group. At 0, 6 and 12 months the volunteers will be submited     to: clinical analise, cardiorespiratory analise (ergoepirometric test), quality of life     questionare (Short Form-36 [SF-36]), ambulatory blood pressure monitoring during 24 hours and     to 2 experimental sessions where the cardiovascular responses to insulin action     (euglicemic/hiperinsulinemic clamp) and to physical and mental stress (microneurography) will     be accessed. Besides these, the volunteers of the sedentary group will be submited to an     extra session at 6 months of study evaluate the physiological answer to insulin infusion     after an acute session of exercise.   "
249415|NCT01120678|"     The purpose of this study is to determine whether analysis of specific serum biomarkers will     improve the diagnosis of late onset neonatal sepsis and to determine the correlation between     plasma levels of specific cytokines and bacteremia in NICU patients >3 days of age.   "
249416|NCT01120691|"     This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in     patients with severe to very severe COPD.   "
249417|NCT01120704|"     Many smokers fail to take their smoking cessation medication as recommended. This research is     designed to identify treatments that improve the use of cessation medications and to     determine whether an increase in medication use results in increased cessation success. This     research will also identify treatments that help people stay quit after a quit attempt and     will pioneer more efficient research methods.   "
249418|NCT01120717|"     The study is designed to provide long-term safety data for QVA149 in patients with moderate     to severe chronic obstructive pulmonary disease (COPD).   "
249419|NCT01120730|"     HES 200/0.5 10% is equal to ringers lactat solution.   "
249420|NCT01120743|"     The primary goal of this project is to identify the source of cytokines that are released     into circulation during graft reperfusion. Seventeen patients scheduled to have adult     cadaveric liver transplantation at the Milton S. Hershey Medical Center were contacted as     prospective participants. Blood samples were obtained from the radial artery, the portal     vein, and from the graft irrigation. The level of pro-inflammatory cytokines was verified and     compared with the amount of catecholamines used to maintain hemodynamic stability.   "
249421|NCT01120756|"     Some of the most common and disabling consequences of brain injury are deficits in cognition,     such as difficulty with sustained attention, memory, organization, and goal management. The     long-term goal of this research program is to develop and test novel neuroscience-based     cognitive assessment tools and interventions for improving attentional regulation and related     executive function brain processes involved in goal-directed behavior.   "
249422|NCT01120769|"     The purpose of this study is to test the hypothesis that acetaminophen will reduce lipid     peroxidation and isoprostane formation during reperfusion after percutaneous     revascularization for acute myocardial infarction.   "
249426|NCT01114451|"     Whenever a person has a cesarean section there is a risk that there will be a problem with     healing of the wound. The most common type of wound healing problem is separation and opening     of the skin and fatty tissue just beneath the skin. This type of wound healing problem     happens more often when the patient has a high body weight. In most cases, metal staples are     used to bring the skin together to close the wound. Usually, the staples are left in place     for a longer time when the woman is heavy, in hopes of decreasing the chance of wound healing     problems. But it is not known if leaving the staples in for a longer time is actually     helpful. In some cases, leaving the staples in longer may cause more pain and will require     you to see the doctor again to get the staples taken out. The purpose of this study is to see     if there is any difference in how the wound heals in heavy women after cesarean section when     the skin staples are removed after a short period of time versus a long period of time.   "
249427|NCT01114464|"     The aim of this protocol is to study the deleterious impact of adjuvant chemotherapy or     neoadjuvant chemotherapy on ovarian reserve in young women suffering from breast cancer. A     new relevant ovarian reserve marker, serum Anti-Mullerian Hormone, will be used in order to     evaluate precisely the impact of chemotherapy on ovaries during chemotherapy administrations     and after during follow-up (24 months). This strategy offers 2 main advantages : no     modification of the traditional care of patients (treatment, organisation, follow up …) and     use of a non invasive marker (serum). The final objective is to give precise information to     patients on their future fertility after remission.   "
249428|NCT01114477|"     The major objective of this observational study is to describe clinical outcomes of patients     receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice.   "
249429|NCT01114490|"     This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib.   "
249430|NCT01114503|"     The purpose of this study is to investigate the safety and tolerability of otelixizumab in     patients with Graves' ophthalmopathy (thyroid eye disease). There is currently no alternative     therapy available for this condition other than treatment with steroids, or radiotherapy and     surgery. The study also includes a comparison of the current steroid treatment,     methylprednisolone, with the proposed new otelixizumab treatment.   "
249509|NCT01122056|"     The purpose of this study is to investigate the effects and tolerability of exercise on side     effects of injectable disease modifying treatments in multiple sclerosis. The investigators     main hypothesis is that controlled exercise is safe and can be well tolerated in patients     with multiple sclerosis and it can improve disease modifying treatment related side effects     such as fatigue.   "
249431|NCT01114516|"     Though cervical insufficiency is a common cause of second trimester pregnancy loss, the     placement of an emergent cerclage in these patients is thought to improve perinatal outcomes.     It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated     by need for emergent cerclage.      The objective is to determine whether administration of peri-operative antibiotics and     indomethacin to patients receiving emergent cerclages for cervical insufficiency increases     latency period to delivery compared with patients receiving emergent cerclage alone.   "
249432|NCT01114529|"     The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to     everolimus conversion at 10-14 weeks post transplantation improves renal allograft function     without compromising efficacy compared to standard CNI treatment in de novo renal allograft     recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen     on evolution of cardiovascular parameters in de novo renal allograft recipients   "
249433|NCT01114542|"     This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect     on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1     diabetes.   "
249434|NCT01114555|"     The purpose of this study is to find how good and how safe the combination of irinotecan,     temozolomide and bevacizumab is for patients with resistant or recurrent neuroblastoma. These     drugs have each been given separately to patients, but they have never been given all     together. Irinotecan and temozolomide are two drugs that have been used together to treat     neuroblastoma in many people. These drugs are considered chemotherapy. Bevacizumab is another     drug used to treat cancer. It is made by a company called Genentech. Bevacizumab is an     antibody. Antibodies are proteins that are found in the blood and can attach themselves to     bacteria and viruses. Bevacizumab attaches itself to a special protein in the bloodstream.     This protein helps tumors grow new blood vessels. Blood vessels carry nutrients to feed the     tumor. Bevacizumab is thought to block this growth of new blood vessels and starve tumors. It     has been used for the treatment of many cancers in adults. It is approved by the FDA for the     treatment of adults with colon cancer and other cancers but not for people with     neuroblastoma. There is only a small amount of information known on using this drug in     children. It has been used with irinotecan before to treat cancer but not in children with     neuroblastoma.   "
249435|NCT01120808|"     Blisters are a very common complaint in both the general population and also the athlete.     This study's aim is to determine whether applying paper tape (an inexpensive and common     component of most foot care kits) to the foot of endurance runners prevents the frequency and     severity of friction blisters.   "
249436|NCT01120821|"     The purpose of this research study is to evaluate the safety and effectiveness of patients     with Polycythemia Vera treated with Gleevec.   "
249437|NCT01120834|"     This will be a phase I/II study of 5-azacitidine in combination with vorinostat in patients     with relapsed or refractory DLBCL. Combination therapy with methyltransferase inhibitors and     histone deacetylase inhibitors is highly synergistic in DLBCL cells, and both classes of     drugs can also synergize powerfully with standard anti-lymphoma chemotheraputics such as     doxorubicin in pre-clinical studies. We hypothesize that azacytidine + vorinostat combination     therapy will be safe and effective in selected patients with relapsed or refractory DLBCL. We     also hypothesize that patients demonstrating objective responses to this combination therapy     display specific epigenetic signatures, and that a biomarker or gene classifier can be     generated which will identify those patients likely to respond.   "
249438|NCT01120847|"     The current research program aims to study how sleep disordered breathing, age and genetics     affect memory in older adult veterans with Posttraumatic Stress Disorder (PTSD).      The study will help researchers and clinicians better understand the relationship among PTSD,     sleep disordered breathing, genetics and memory function.   "
249443|NCT01120912|"     The study will be a non-randomized, open label, single dose, single blind, placebo control,     single center, single arm study in Type I diabetes patients. The study will include single     dose administration for the evaluation of single dose acute toxicity, pharmacokinetics and     activity.   "
249444|NCT01120925|"     Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver     transplantation is the sole effective therapy available to these patients. However, limited     number of donors, post surgical complications, immunological rejection, and financial     consideration are it`s crucial problems. The plasticity of stem cells in bone marrow (BM) to     differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have     applied BMC injection to induce regeneration of myocardium and blood vessels. In this study,     the investigators will study safety and feasibility of twice transplantation of Autologous     bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through     the portal vein in patients with decompensate cirrhosis.   "
249458|NCT01121107|"     The purpose of this clinical study is to evaluate the safety and clinical effectiveness of     use of a physician-directed, patient self-management system, guided by left atrial pressure     measurements, for use in patients with heart failure. The system allows patients to adjust     their HF medications daily based on a physician-directed prescription plan and their current     HF status, similar to the manner in which diabetes patients manage their insulin therapy. The     goal of the LAPTOP-HF study is to demonstrate reductions in episodes of worsening heart     failure (HF) and hospitalizations in patients who are managed with the left atrial pressure     (LAP) management system (treatment group) versus those who receive only the current standard     of care (control group).   "
249459|NCT01121120|"     The purpose of this study is to determine the safety and effectiveness of TXA127 in     accelerating the time it takes for patients to recover their platelet counts following a     Autologous Peripheral Blood Stem Cell transplant.   "
249445|NCT01120938|"     Sudden infant death syndrome (SIDS) is the leading cause of death among infants between 1     month and 1 year of age in the developed world. SIDS continues to be a phenomenon of unknown     cause. The best approach to for prevention in high risk infants is unclear. Several     substantial lines of evidence indicate that pacifiers have a protective effect on the     incidence of SIDS. These studies were significantly powered and the results were consistent     world-wide. The explanation for the protective effects of pacifiers on SIDS prevalence is     unclear. A recent case report from New Zealand showed by means of nasopharyngeal films of a     baby with and without a pacifier the possibility that sucking on a pacifier is associated     with a forward movement of the tongue with enlargement of the upper airways' cross sectional     area. Indeed, this hypothesis was originally postulated 30 years ago by Cozzi et al.      Working hypothesis and aims: Our hypothesis is that since the upper respiratory tract is that     portion of the airway that imposes the greatest resistance to ventilation, sucking on a     pacifier results in upper airway dilatation, thus greatly reducing upper airway obstruction     and improving ventilation at a stage when infants are virtually obligate nasal breathers. It     should be stressed that airway resistance is proportional to the 3rd power of the radius of     the airway, thus even a relatively small increase in airway diameter may have a profound     effect on airway resistance and respiratory mechanical work of breathing! In young infants     and those with underdeveloped respiratory center drive, this decrease in the work of     breathing could certainly be sufficient to minimize the risk of SIDS as described above.Thus,     the aim of this study is to demonstrate the effect of sucking on a pacifier on upper airway     patency.   "
249446|NCT01120951|"     The study aims to to establish whether or not measurement of respiratory rate taken using the     Anaxsys Technology Ltd Respiratory Counter (R8 Counter) are equivalent to manual respiratory     rate counting methods in patients receiving oxygen via a face mask.   "
249447|NCT01120964|"     This clinical trial will determine the safety and effectiveness of intravenous L-citrulline     in children undergoing cardiopulmonary bypass during heart surgery. Participants will be     randomly assigned to either L-citrulline or a placebo (a substance that has no medicine in     it).      Citrulline is a protein building block in the body that can convert into another substance,     nitric oxide (NO), which controls blood pressure in the lungs. Increased blood pressure in     the lungs can be an important surgical problem; it may also lead to problems following     surgery, such as severe high blood pressure in the lungs (pulmonary hypertension), increased     time spent on a breathing machine, and a longer stay in the intensive care unit (ICU). The     hypothesis of this study is that perioperative supplementation with intravenous citrulline     will increase plasma citrulline, arginine and NO metabolites and prevent elevations in the     postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical     ventilation.      The objective of this study is to determine in a randomized placebo controlled phase IB     multicenter clinical trial if a revised protocol of intravenous L-citrulline delivery given     perioperatively achieves a plasma citrulline level of > 100 umol/L in children undergoing     surgical repair of an atrial septal defect,ventricular septal defect or an atrioventricular     septal defect.   "
249448|NCT01120977|"     The treatment of Growth Hormone deficiency (GHD) patients with GH, often induce fluid     retention; this effect is dose dependent and temporary. The symptoms are swelling of soft     tissue and joint stiffness. The objective of this study is to create bioelectric     impedance/arm muscle area (BIA/AMA) reference data, as a measurement of hydration status, of     healthy persons of both genders in the age 20-70 years.   "
249449|NCT01120990|"     Assessment of the accuracy of a Blood Pressure Measuring Device with a digital     display-column, NISSEI DM 3000, according to an adaptation of the European Society of     Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure     Measuring Devices in Adults.   "
249450|NCT01121003|"     8 healthy male volunteers will be studied each on 3 occasions, ie        -  after 4 days on a weight maintenance diet containing 5% simple sugars + low physical          activity        -  after 4 days on a weight maintenance diet containing 30% fructose + low physical          activity        -  after 4 days on a weight maintenance diet containing 30% fructose + high physical          activity At the end of each of these 3 periods, fructose induced hepatic de novo          lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load)          and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol)          will be measured   "
249451|NCT01121016|"     Hypothesis: Add-on therapy with oral montelukast (Mon) to inhaled budesonide (BUD) may     achieve better control of cough caused by nonasthmatic eosinophilic bronchitis (NAEB) with     faster reduction of airway eosinophilia.      Objective: To evaluate the efficacy of add-on therapy with Mon to inhaled corticosteroids     (ICS) in the treatment of adult patients with chronic/subacute cough caused by NAEB diagnosed     in outpatient setting. Primary endpoint：cough severity rated as cough visual analogue score     (VAS)1 and eosinophil count in induced sputum during 4-week BUD monotherapy or Mon adjunct     therapy.   "
249452|NCT01121029|"     The purpose of this study is to determine if autologous nonmyeloablative hematopoietic stem     cell transplantation is able to induce prolonged and significant increases of C-peptide     levels associated with absence of or reduction of daily insulin.   "
249453|NCT01121042|"     The aim of this study is to evaluate the overall effectiveness of Ondansetron as an     adjunctive or add-on medication in the treatment of Schizophrenia. This study is a double     blind, placebo-controlled, randomised, 12 week trial.   "
249454|NCT01121055|"     Many patients undergoing flexible bronchoscopy (FB) experience anxiety and discomfort during     the procedure. The investigators want to evaluate whether an additional Lorazepam     premedication would improve patient satisfaction for FB.   "
249455|NCT01121068|"     Interferon gamma releasing assay(IGRA) is useful to diagnose latent tuberculosis.     However,IGRA responses could show within-subject variability. We wanted to determine     long-term IGRA variability in health-care workers who continuously expose to tuberculosis     patients.   "
249456|NCT01121081|"     This is a Randomized, Double-Blind, , Placebo Controlled, 18 Week Study To Evaluate the     Efficacy of adjuvant 9-cis-β-Carotene Rich powder of the Alga Dunaliella bardawil in Subjects     With Plaque type Psoriasis treated by Narrow Band UVB therapy.   "
249457|NCT01121094|"     The purpose of this study is to prospectively evaluated the T2* values of normal feti.A     standardized scale of T2* values for fetal and neonatal iron organ overload have yet to be     reported or devised.   "
249461|NCT01121432|"     Although mediastinal tuberculous lymphadenopathy is not rare in adults of such an     abnormality. Isolated mediastinal without a parenchymal lung lesion in adults is unusual with     the incidence of 0.25%-5.8%. It occurs most commonly in Asian and black people, and presents     a diagnostic problem. The definite diagnosis requires microbiology or pathology study.      Cervical mediastinoscopy remained the gold standard to sample the mediastnial lymph nodes,     but this technique can access lymph node station 1-4, 7 only. EBUS-TBNA allows the     mediastinal lymph nodes to be targeted in the areas accessible to cervical mediastinoscopy,     as well as some hilar nodes (lymph node stations 2-4, 7, 10-12). Currently, the main     indication of EBUS-TBNA is the mediastinal nodal staging of NSCLC after recent meta-analyses     established the comparable sensitivity and specificity of nodal staging by EBUS-TBNA and     cervical mediastinoscopy. Theoretically, mediastnial tuberculous lymphadenopathy could be     diagnosed by the method of EBUS-TBNA. Douglas F. Johnson was the first doctor to report 2     cases of mediastinal tuberculous lymphadenopathy diagnosed by EBUS-TBNA in 2009. There are     currently no much data on the use of this technique in this field. The investigators plan to     perform a prospective single-center study to investigate the diagnostic efficacy of     mediastinal tuberculous lymphadenopathy by sampling the culprit nodes via EBUS-TBNA.     Concomitant sputum specimen for acid-fast stain and mycobacterial culture were collected as     well.   "
249462|NCT01121445|"     Continuous positive airway pressure (CPAP) is the most commonly used treatment for     obstructive sleep apnea. Nasal symptoms such as dryness, itching and congestion are common in     CPAP users. Nasal and sinus saline irrigation has been shown to improve these symptoms in     individuals with chronic nasal congestion and sinusitis. This is an 8 week study that     investigates whether daily saline nasal and sinus irrigation reduces nasal symptoms in     patients using CPAP, improves quality of life and CPAP compliance.   "
249463|NCT01121458|"     Pulmonary arterial hypertension (PAH) is a rare blood vessel disorder of the lung in which     the pressure in the pulmonary artery (PA) rises above normal levels and may become life     threatening. PAH is frequently misdiagnosed and has often progressed to late stage by the     time it is accurately diagnosed. PAH has been historically chronic and incurable with a poor     survival rate. However, new treatments are available which have significantly improved     prognosis. Right-heart catheterization (RHC) is the most accurate and useful test for PAH,     and the only test that directly measures the pressure inside the PA. It is performed in all     patients at least once, to get a definitive diagnosis of PAH.      The most commonly used medication for this purpose is intravenous nitroprusside, however this     medication in about 25-30% of patients is not well tolerated as it cause fast heart rates,     which is not well tolerated by patients with pulmonary hypertension and/or heart failure. The     CARVE study assesses the effect of Clevidipine, an ultra-short acting vasoselective calcium     antagonist, on pulmonary vascular resistance (PVR) and its utility for pulmonary     vasoreactivity testing during right heart catheterization (RHC) of patients with pulmonary     hypertension (PAH).   "
249464|NCT01121471|"     The purpose of this study is to determine the role of CLA as a complementary therapy to     improve body composition, glucose tolerance, fasting plasma glucose and insulin, and     hemoglobinA1c (HbA1c) in subjects with type 2 diabetes mellitus (T2DM).   "
249465|NCT01121484|"     A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine     succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and     postmenopausal women with major depressive disorder   "
249466|NCT01121497|"     The purpose of this study is to determine whether the administration of physostigmine in     combination with sedation for colonoscopy can minimize the cognitive decline at the time of     hospital discharge   "
249467|NCT01121510|"     The QuickClose Design 9 is a prospective, non randomized study, to evaluate the safety and     efficacy of the QuickClose design 9 closure device.      patient undergoing a diagnostic or therapeutic angiogram procedure will be treated with the     QuickClose Design 9. Patients will be monitored until 30 days after the procedure.   "
249468|NCT01121523|"     The present study is an examination of cue-directed tactile stimulation (CTDS), administered     by mothers and NICU nurses, on infant and maternal stress reactivity, infant immune system     functioning, maternal parenting cognitions, and parenting competence.   "
249470|NCT01121549|"     The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen,     who either continued the same treatment or switched to Aromasin® for a total treatment period     of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore     appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in     which it is used on a broader sample of patients and under the standard conditions of use as     stipulated in the MA. This Non-Interventional study was designed to address these issues.   "
249471|NCT01121562|"     The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit     response rate.   "
249472|NCT01121575|"     Lung cancer tumors become resistant to the first generation epidermal growth factor receptor     (EGFR) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell     signaling pathways: the cMET pathway and the EGFR pathway. Both resistance mechanisms can     occur at the same time, in the same patient and even in the same tumor. This study combines a     second generation EGFR inhibitor and a cMET inhibitor to block both these pathways in order     to overcome resistance and treat this disease.   "
249473|NCT01121588|"     This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with     tumors except non-small cell lung cancer that are positive for ALK.   "
249474|NCT01121601|"     Study of phase II: Clinical study national, exploratory, multicentric, prospective,     randomized, as a double blind man evaluating the effectiveness and the tolerance of the     treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of     operational adherences post.3 Study of phase III: Clinical study national, multicentric,     prospective, randomized, controlled, as a double blind man comparing a group controls with a     group of patients treated by a surgical gel of sealing containing polyethylene glycol in the     prevention of hepatic adherences of novo post operational.   "
249475|NCT01121614|"     Ultrasonic cutting-coagulation devices (UCCD) are surgical instruments which use ultrasonic     energy to cut through and coagulate tissue. An Ethicon version (trademarked Harmonic     Scalpel and Ultracision) is used in a variety of surgical procedures. Its surgical     performance has been directly compared with that of electrically powered diathermy     instruments in animal and clinical trials. LOTUS is a company based in Ashburton, Devon,     which has developed a UCCD that works in a slightly different way to the Harmonic Scalpel.     There are also bipolar feedback diathermy instruments which use electrical energy to seal     blood vessels, such as LigaSure. The aim of this project is to obtain data to design a fully     powered trial to answer the research question: do LOTUS and Ethicon UCCDs and LigaSure     bipolar device reliably seal and divide blood vessels? The investigators will also be     examining the degree of collateral tissue damage caused by each instrument.      Hypotheses        -  LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure are equivalent at sealing and dividing          mesenteric blood vessels.        -  LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure cause equal amount of collateral          damage when sealing and dividing blood vessels.   "
249476|NCT01121627|"     Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system     disease that influences not only the motor but also the cognitive and autonomic systems. The     main cognitive impairment in individuals with PD is found in executive function (EF). EF is     defined as a set of cognitive skills necessary for planning, monitoring and executing     sequences of complex activities.      The primary study hypothesis is that computer-based training aimed at improving executive     function will have a beneficial effect on gait functions.   "
249477|NCT01121640|"     The Novel Markers Trial will compare the safety, feasibility and effectiveness of two     different epithelial ovarian cancer screening strategies that use CA125 and add HE4 as either     a first or second line screen. This study is the next step in a larger research effort to     develop a blood test that can be used as a screening method for the early detection of     epithelial ovarian cancer.   "
249478|NCT01121653|"     Use lay language.      The aim of this study is to evaluate on pain scores (neuropathic pain questionnaire and pain     numeric scale) and on quality of life, the effect of oral magnesium intake on patients with     neuropathic pain comparing with patients receiving placebo,. The study drug will be taken     during 4 weeks.   "
249479|NCT01121666|"     Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to     the number of oocytes retrieved in women for assisted reproductive treatment.   "
249480|NCT01121679|"     Because of increased life expectancy and improved therapeutic methods in cardiology, the     proportion of very old patients with cardiovascular disease increases. However, clinical     practice in real life are still insufficiently known in this population. The     recommendations still lack of studies specifically devoted to elderly or very elderly, an     extrapolation of data based on evidence obtained in younger populations.      This is a multicenter observational study during a day. On this day, all participating     centers fill a questionnaire for each patient 80 years or older hospitalized in their     service.   "
249481|NCT01121692|"     Couples who use alcohol and other drugs (AOD) in South Africa are at high risk for engaging     in risky sex behavior within their relationships and with other sexual partners. In addition,     high levels of gender-based violence (GBV) in the Cape Town area intersect with AOD abuse and     sex behavior. All of these interconnections raise concern for the importance of HIV     prevention strategies within or surrounding drinking venues, where many of these behaviors     occur.      The specific aims of this study are as follows:      Aim 1. To characterize the types of drinking venues (e.g., licensure status, size, plumbing,     type of alcohol provided), their immediate context (e.g., observed availability and use of     other drugs, observable violence and sexual activity), and surrounding neighborhood     characteristics (e.g., quality of streets, building structures, and availability of     electricity and plumbing) in the sampled neighborhood blocks in several large Black/African     and Coloured communities in Cape Town, South Africa.      Aim 2. To refine through qualitative methods the proposed interventions in relation to     skills-building to address gender-role expectations, sexual partnering, gender and power,     violence, and environments where drinking and sexual risk behaviors occur.      Aim 3. To conduct a randomized group trial to compare the relative efficacy of a     comprehensive intervention (Condition 3: Enhanced Couples) to the gender-focused intervention     (Condition 2: Gender) and to (Condition 1: Men's Control and Women's CoOp) on reducing     alcohol and other drug (AOD) use, sexual risk behavior, and gender-based violence at 6 month     follow-ups. Aim 4. To assess the mechanisms through which the intervention effects may occur     (e.g., mediators involving self-efficacy and condom mastery, negotiation, and communication     skills) and to identify groups for whom the interventions have the greatest effect (e.g.,     partner characteristics such as race, gender, and age and neighborhood factors such as     poverty) on study outcomes of AOD use, sexual risk, and gender-based violence.   "
249482|NCT01121705|"     The study aimed at evaluating whether current 24 weeks length of combination treatment is     appropriate or not for patients with HCV genotype 3 infection.   "
250966|NCT01140750|"     The purpose of this study is to evaluate if the variability of biological signals, such as     heart rate and temperature, can predict weaning from mechanical ventilation in patients with     failure to wean.   "
249483|NCT01121718|"     This study will try to define an appropriate dose of the investigational drug indocyanine     green (ICG) in combination with near infrared (NIR) imaging to use for future studies.      ICG is a dye which has been in use since the 50s, and is approved for testing liver function     and measuring blood flow from the heart. It has been used in studies to map lymphatic     pathways in lung and breast cancer and information from those studies suggest it may help     identify lymph nodes associated with melanoma. ICG can be detected within the body using     near-infrared light cameras.      In this study the investigators are looking at how easily ICG can get to the first lymph node     (sentinel lymph node [SLN]) associated with melanoma, whether the investigators can see the     path of the ICG and the SLN using a near infrared camera, and what dose of ICG works the     best. While the current method for SNL mapping, known as lymphoscintigraphy, is effective it     does provide a small amount of radiation. This study will compare the investigators results     to the standard procedure.   "
249484|NCT01121731|"     The general aim of this study is to determine if 3 MIU of IFN-α5 in monotherapy, and 1,5 MIU     of IFN-α5 combined with 1,5 MIU of IFN- α2b, are safe dose levels as well as to investigate     the antiviral efficacy and pharmacodynamics (PD) of such doses and drugs in     treatment-experienced HCV patients with genotype 1 chronic infection, after 29 days of     treatment. It is also intended to determine pharmacokinetics (PK) of the safe dose achieved     of IFN-α5 in monotherapy.   "
249485|NCT01121744|"     The primary objective of this study is to evaluate the pharmacokinetic (PK) and safety     associated with Supralimus-Core™ Sirolimus Eluting Coronary Stent system in the treatment of     single de novo lesions in native coronary arteries between 2.5 to 3.5 mm in diameter.   "
249486|NCT01121757|"     The purpose of this study is to evaluate the response and safety in subjects receiving the     drugs lenalidomide and azacitidine when each drug is given by itself and when the drugs are     taken together. This study is open for patients with relapsed or refractory follicular or     marginal zone lymphoma.   "
249488|NCT01121783|"     The purpose of the study is to determine whether the sweet taste receptors in the gut are     involved in sensing sweet substances and controlling appetite and the amount we eat.     Lactisole is a substance commonly used in food products to reduce the perceived sweetness of     certain sugars and sweeteners. The aim of this study is to investigate whether the responses     to a glucose solution, intragastrically administered to healthy male and female volunteers,     is affected by the presence of lactisole in the gut. Understanding the mechanisms by which     nutrients are initially detected in the gut and how they influence food intake is critical to     the development of novel food products that could reduce food consumption.   "
249489|NCT01121796|"     Vitamin D has been shown to influence a multitude of systems. We intend to see whether     different types of Vitamin D supplements have an effect on inflammatory bowel disease.   "
249490|NCT01121809|"     Hypothesis: the intracellular concentrations of raltegravir (RAL) and etravirine (ETV)     administrated as 800 and 400 mg once a day, respectively, are similar to those obtained with     the standard doses of 400 and 200 mg/12h, respectively.      Objective: To analyze the plasma and intracellular concentrations of RAL and ETV     administrated as 800 and 400 mg once daily respectively compared with standard doses of 400     and 200 mg/12h, respectively, and if they support its once daily administration.   "
249491|NCT01121822|"     The aim of this study is to evaluate the new formulation of the influenza vaccine for the     2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the     corresponding population and to check its compliance with the Committee for Proprietary     Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96      Objectives:        -  To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split          virion, inactivated) NH 2010-2011 formulation with the requirements of the Committee for          Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96 in both          age groups        -  To describe the safety of the influenza vaccine (split virion, inactivated) NH 2010-2011          formulation in both age groups   "
249492|NCT01121835|"     Primary Objective:      To demonstrate the superiority of a strategy with insulin glargine in comparison with a     strategy including the premixed insulin in term of percentage of patients reaching HbA1c     (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience     documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1     mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle     management and oral agents.      Secondary Objectives:      To assess the effect of insulin glargine in comparison with premixed insulin on :        -  Evolution of HbA1c level during the treatment period Percentage of patients who reach          the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia          confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L)        -  Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience          documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L)          >Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience          documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L)          >Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles        -  Evolution of weight        -  Hypoglycemia occurrence        -  Dose of insulins        -  Evolution of liver function        -  Overall safety   "
249493|NCT01121848|"     Primary Objective:      To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV)     will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response     Evaluation Criteria In Solid Tumors) criteria or death      Secondary Objective:      To evaluate other measures of tumor responses, safety, quality of life (QoL), and health     utility assessment.   "
249494|NCT01121861|"     Several methods have been developed to address and reduce preexisting astigmatism. The     refractive results associated with the use of toric IOLs are likely to be more predictable.     Other advantages of toric IOL include absence of need for any additional astigmatic     correction procedure during cataract surgery, faster visual recovery as well as the     reversibility of the procedure. There has not been any trial carried out to evaluate the     results of toric IOL in either the investigators local population or in East Asia. Hence, the     investigators set out to evaluate and compare the efficacy, safety, predictability and     stability of the STAAR and Alcon toric IOL in Asian eyes.   "
249495|NCT01121874|"     Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who     fail to respond to conservative treatment may benefit from surgery; however, controversy     exists over the most effective surgical technique. A popular technique, ligament     reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by     reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist.      We believe that use of a suture fixation system to reconstruct the palmar oblique ligament,     instead of harvesting a wrist tendon, may provide a superior repair. The objective of this     study is to compare functional outcome measurements among patients who receive CMC     arthroplasty using a suture fixation system (investigational group) to those who receive LRTI     surgery (control group). We hypothesize that patients in the investigational group will     demonstrate superior functionality, compared to patients in the control group.   "
249496|NCT01121887|"     Aim: to assess the effect of adding Motivational Interviewing (MI) to the existing smoking     cessation treatment protocol at the Swedish National Tobacco Quitline (SNTQ).      Methods: Experienced counsellors at SNTQ either received further training in the standard     treatment (ST) protocol (including Cognitive Behavioural Therapy (CBT)) or a comprehensive     regime of training in MI. 1309 clients were randomized to either the ST group or the group     with MI added to the treatment protocol. In order to ensure treatment integrity among     counsellors, MI skill was assessed using the Motivational Interviewing Treatment Integrity     Code (MITI).   "
249497|NCT01121900|"     The objective of this study was to compare the pharmacokinetic profiles of the test product,     300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when     administered as a single dose, and the reference product, 100 mg trazodone HCl     immediate-release tablets (Apotex Corp), when administered three times daily. For this     purpose the rate and extent of absorption of trazodone and formation of     m-chlorophenylpiperazine (mCPP) after administration of the two formulations, were compared     under fasting conditions.   "
249498|NCT01121913|"     The objectives of this study were:        -  to compare the pharmacokinetic profiles of two prototype controlled-release (CR)          trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC          (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets) under          fasting condition;        -  to assess the controlled release properties of the two prototype formulations;        -  to select a prototype formulation for further development;        -  to validate the blood sampling schedule for future pivotal pharmacokinetic studies;        -  to determine the appropriate sample size for pivotal studies based in the intra-subject          variability.   "
249499|NCT01121926|"     The purpose of this study was to compare the pharmacokinetic profiles at steady state of the     test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing     Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl     immediate-release tablets (Apotex Corp.), when administered three times daily, for one week.     For this purpose, the rate and extent of absorption of trazodone and formation of     m-chlorophenylpiperazine (mCPP) after administration of multiple doses of up to 300 mg of     each of the two formulations was compared.   "
249500|NCT01121939|"     The purpose of this Phase II trial will be to define the activity of a VEGF inhibitor      bevacizumab, HER1/HER2 inhibitor pertuzumab, and sandostatin for patients with      advanced neuroendocrine cancers. In particular, the efficacy of bevacizumab and      pertuzumab treatment is of great interest. The primary endpoint of this trial will be      response rate. Toxicity and progression-free survival will be obtained and evaluated.   "
249501|NCT01121952|"     The purpose of this trial was to explore the effects of chiropractic manipulation in patients     with talo-crural joint dysfunction.   "
249502|NCT01121965|"     This study is designed to verify hypothesis that early vitrectomy may prevent impending     macular hole from progression to full-thickness macular hole.   "
249503|NCT01121978|"     This study is designed to identify the effect of current vitreous surgery for symptomatic     macular tractional maculopathy.      Characteristics of this study is as below        1. Multicenter, prospective clinical trial. (early surgical intervention vs.surgical          intervention when full-thickness macular hole formation or deterioration of visual          acuity occurs)        2. Non-randomized study (decision was made by patients after full explanation)        3. After 1 year follow up, functional change(visual acuity)and anatomical change would be          evaluated   "
249504|NCT01121991|"     In-vitro fertilization (IVF) of human oocytes followed by the replacement of embryo in the     uterine cavity has become a well established treatment for female infertility attributable to     damaged fallopian tubes, endometriosis or unexplained causes where alternative forms of     therapy have failed. The most commonly used protocols of follicular stimulation now employs     follicle stimulating hormone (FSH) and long-acting agonists of gonadotropin releasing hormone     (GnRH) to prevent the occurrence of a mid-cycle luteinizing hormone (LH) surge and to ensure     the induction of well-synchronized larger cohort of ovarian follicles.      The results of a number of studies have demonstrated that in the majority of clinical     situations, FSH administration alone is sufficient to achieve successful follicular     development. A study had shown that in subjects receiving recombinant human-follicle     stimulating hormone (r-hFSH) and recombinant human-luteinizing hormone (r-hLH), pregnancy     rates were similar in the younger and older age groups, however, in women receiving r-hFSH     alone, there was a significant decline in pregnancy rates for women 35 and older. This     particular study also went on to show that the subgroup of women 35 and older, may benefit     from supplementary r-hLH. A number of studies have been conducted to assess the safety and     efficacy of r-hLH administered concomitantly with r-hFSH in the presence of developing     follicles to reduce the rate of growth of intermediate and small follicles while allowing the     dominant follicle to continue to progress.      This was a Phase III, open-label, multicentre study to evaluate safety and efficacy of     addition of Recombinant Human-Luteinizing Hormone (Luveris) to a standard assisted     reproductive technologies (ART) protocol.   "
249505|NCT01122004|"     The studied patients will be given randomly one of three following drugs1:Gabapentin2:     Pregabalin or placebo for 3 days after Photorefractive keratectomy surgery. The pain will be     measured based on visual analog scale(VAS) on the day of operation and on the 3 rd day     (morning, evening) and then compared among three groups.   "
249506|NCT01122017|"     The present study was conducted among a group of Iranian patients suffering from varus knee     in order to compare advantages and disadvantages of ROWHTO (Retro-Tubercle Opening Wedge High     Tibial Osteotomy) technique when compared with previously described approaches of     opening-wedge osteotomy.   "
249507|NCT01122030|"     The primary objective of the study is to evaluate the safety of single doses of oral     naldemedine in adults physically dependent on opioids.   "
249508|NCT01122043|"     The purpose of this study is to determine the clinical safety and efficacy of the EndoGlide     as a donor insertion device in DSAEK surgery. The investigators hypotheses is that the     Endoglide will cause less endothelial damage compared to the investigators previous technique     of glide insertion but will have the same low complication rate as the previous device. Hence     the investigators aim to evaluate the surgical efficacy of the EndoGlide to enable consistent     double coiling of the donor lenticule in DSAEK surgery with minimal endothelial touch.     Evaluate ease of insertion of the EndoGlide through a 4 to 4.5mm scleral tunnel wound.     Evaluate ability of the EndoGlide to consistently effect complete wound sealing, so as to     stabilize anterior chamber with an AC maintainer in position. Evaluate ease of donor     pull-through from the EndoGlide chamber into the AC and to evaluate spontaneous uncoiling of     the donor in the AC. Evaluate clinical efficacy and safety outcomes in EndoGlide assisted     DSAEK surgery in study patients with corneal decompensation requiring DSAEK surgery, in terms     of postoperative visual acuity, primary graft failure rate, donor dislocation rate,     endothelial cell loss, and deturgescence of the host cornea and donor lenticule as measured     by corneal thickness parameters with the Visante AS-OCT. The investigators will perfprm a     prospective Phase II clinical trial using the EndoGlide for donor insertion in 100 corneal     patients referred to the SNEC Corneal Clinics of the study investigators with moderate     degrees of corneal decompensation from a variety of disorders which require DSAEK corneal     transplantation surgery, with or without concurrent cataract surgery, to restore visual     acuity.   "
249510|NCT01122069|"     In patients with acute myocardial infarction, treatment logistics are primarily defined based     upon ST segment shift in the electrocardiogram. While patients with ST elevation (STEMI) are     forwarded to immediate coronary angiography and percutaneous coronary intervention, patients     without ST elevation (NSTEMI) are initially medically treated and recommended coronary     angiography within 48-72 hours.      Early invasive treatment has been found cost-effective in intermediate and high-risk NSTEMI     patients and current guidelines recommend use of the Thrombolysis in Myocardial Infarction     (TIMI) risk score to identify patients who will benefit from early intervention due to high     risk of new infraction and cardiovascular death. However, new research has suggested that     TIMI risk score may not always identify patients with severe angiographic disease.      The purpose of this study was to assess if contrast echocardiography could be used to     identify NSTEMI patients with angiographically severe disease independent of their TIMI risk     score.   "
249511|NCT01122082|"     The purpose of this study is to observe the influence of carbohydrate-to-fat balance on     liking, wanting and food consumption in humans.      16 normal-weight men (age: 23 ± 3 y)had completed a randomized 4-condition crossover study.     The sessions differed by the composition of the breakfast which was rich in carbohydrates     (HCB), low in carbohydrates (LCB), rich in fat (HFB) and low in fat (LFB). The HCB and HFB     contained 2072 kJ, while the LCB and LFB contained 565 kJ. Two hours and 20 min later, energy     expenditure (EE) and respiratory quotient (RQ) were measured before olfactory liking for 4     foods items and then ad libitum energy intake (EI) during a snack (sweet and fatty toast)     were evaluated.   "
249512|NCT01122095|"     Hypothesis 1: Patients with psoriasis will have clinical and laboratory assessments differing     from control patients.      Hypothesis 2: Patients with psoriasis will have laboratory alterations that correlate with     other clinical characteristics of their psoriasis.   "
249513|NCT01122108|"     The objective of this study is to compare the acceptability of Colesevelam HCl powder for     oral suspension versus generic cholestyramine via the BASA scale, based upon an anticipated     equivalent cholesterol lowering doses of each comparator drug.   "
249514|NCT01122121|"     The purpose of this study is to compare the efficacy and safety of combined radiotherapy and     hormone therapy and hormone therapy alone in the treatment of clinically locally advanced     prostate cancer (T3-T4 or pT3 on biopsy, N0, M0).   "
249515|NCT01122134|"     Intravenous artesunate is highly effective with rapid schizonticidal action and improved     clinical outcome   "
249516|NCT01122147|"     Recurrent aphthous stomatitis is a difficult to treat and quite common chronic inflammatory     disease of the oral mucosa. This study evaluates the fluid extract from Chamomilla recutita's     safety and effectiveness in treatment of aphthous stomatitis .   "
249517|NCT01122160|"     Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and     vegetables. The purpose of the study is to determine whether absorption of anthocyanins     occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of     an over-the-counter medicine, Prilosec TM, alters absorption of anthocyanins from     strawberries and blackberries.   "
249518|NCT01122173|"     The purpose of this study is to assess the safety and performance of the Hansen Medical     Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation     catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats     originating in the upper chambers of the heart).   "
249519|NCT01122186|"     The primary aim is to test an innovative 8-session intervention, based on Motivational     Interviewing and Cognitive Behavioral Skills-Training for the co-occurrence of     methamphetamine use and highly active antiretroviral therapy (HAART) non-adherence among     methamphetamine using HIV+ MSM in NYC, compared to an 8-session educational (ED) condition.     Participants in the intervention condition will report greater reductions in the number of     days of methamphetamine use and viral load, and greater increases in CD4 counts and     self-reported and objectively measured adherence than those in the education condition.   "
249520|NCT01122199|"     The purpose of this study is to test the safety of the combination of two drugs called RAD001     and AMG479. This study will see what effects (good and bad) RAD001 and AMG479 have on cancer.     This study will also find the highest doses of RAD001 and AMG479 that can be given without     causing severe side effects.   "
249521|NCT01122212|"     In Patients with minor head injury measurement of protein S100 will be introduced to the     emergency departement as another tool to rule out intracerebral bleeding.   "
249522|NCT01122225|"     Acute kidney injury (AKI) is a major organ failure in septic shock. Current medical tests     (serum creatinine and urea) cannot identify AKI until approximately 48 hours after it occurs.     Neutrophil gelatinase-associated lipocalin (NGAL) may be able to predict ischemic AKI more     effectively and faster than serum creatinine and urea levels.      The purpose of this study is to take a blood sample from patients at admission and then at 24     and 48 hours after to test their plasma for NGAL and compare the NGAL levels to their     creatinine and urea levels. The investigators hypothesize that NGAL is an earlier marker to     classify the kidney failure as acute tubular necrosis or pre-renal azotemia than creatinine     and urea.   "
249523|NCT01122238|"     At any given point in time, most smokers are not interested in making a serious quit attempt.     Data suggest that 30% of smokers have no plans to quit, 30% plan to quit at some future date,     30% plan to quit in the next 6 months, and about 10% plan to quit in the next month. While     ~40% of smokers make a quit attempt each year, only about 4-6% of those achieve long-term     success. This means that of the more than 60 million Americans who smoke, only 1 million are     able to quit each year. If we could double the number of quit attempts and maintain     comparable success rates, we could double the number of individuals who will benefit from     living smoke free lives. These observations underscore the need to develop interventions that     increase smokers' motivation or willingness to make quit attempts, and that also increase the     rate of success among those who attempt to quit. The overall goal of this proposed experiment     is to identify effective interventions aimed at increasing motivation for smoking cessation,     increasing quit attempts, and increasing rates of cessation success. Interventions that will     be tested include: use of nicotine gum, use of nicotine patches, motivational interviewing,     and smoking reduction counseling. At minimum, all participants will complete surveys about     their smoking behavior that might increase their motivation to eventually quitting smoking.   "
249524|NCT01122251|"     The purpose of this study is to evaluate the safety and efficacy of fixed combination of     lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan     alone in reducing blood pressure. The study will investigate the dose response relationship     for the combinations and monotherapies.   "
249525|NCT01122264|"     The purpose of this study is to investigate if treatment in erectile dysfunction with a     long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer     treatment adherence and better long term outcomes (over 24 weeks), compared with a     short-acting drug (Sildenafil Citrate) taken as needed.   "
249526|NCT01122277|"     The purpose of this observational study is the prospective documentation and evaluation of     the status quo of volume therapy in German intensive care units.   "
249527|NCT01122290|"     Background: Children's emotional eating is related to greater BMI and less healthy diet but     little is known about the early development of this behavior.      Objective: This study aimed to examine the relationships between preschool children's     emotional eating and parental feeding practices using experimental manipulation of child mood     and food intake in a laboratory setting.      Design: 25 3-5 year old children and their mothers sat together and ate a standard meal to     satiety. Mothers completed questionnaires about their feeding practices. Children were     assigned to a control or negative mood condition. Children's consumption of snack foods in     the absence of hunger was measured.   "
249528|NCT01122303|"     Autologous serum eye drops (ASE) have been becoming popular in treatment of severe dry eye     for the past decade. One of the most beneficial properties of the ASE over artificial eye     drops is the epitheliotropic capacity owing to the presence of growth factors and other     proteins. There have been reports on alteration of serum growth factors in autoimmune     diseases such as rheumatoid arthritis. Alteration in serum growth factors may lead to     different therapeutic effect of ASE. We therefore would like to know if there are any     alteration growth factors, epidermal growth factor (EGF), transforming growth factor-beta1     (TGF-β1), transforming growth factor-beta2 (TGF-β2), and fibronectin, in ASE from     Stevens-Johnson syndrome (SJS) patients with dry eye, which constitutes a major group of ASE     usage in Siriraj Hospital, as compared with non-autoimmune dry eye. We also study stability     of these factors following different storage conditions.   "
249529|NCT01122316|"     The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will     assess the use of the medication metformin to improve quality of life, exercise capacity, and     improved outcomes with patients that have both heart failure and diabetes.      If you participate in this study, you will receive the drug metformin for approximately 3     months. During the study you will undergo comprehensive testing which includes blood draws,     an echocardiogram, and an magnetic resonance imaging (MRI)(if you do not have a pacemaker or     defibrillator). You will also fill out a questionnaire and keep a blood glucose log.      You must be 18 years old to participate. The study drugs, study follow—up visits, and     laboratory tests will be provided free of charge. Participants will be reimbursed up to $200     for their time and travel expenses.   "
249530|NCT01122329|"     This study will examine the brain metabolic effects of AC-1202 (Axona®), a medical food for     Alzheimer's disease. Subjects who meet entry criteria will undergo H215O positron emission     tomography prior to and 90 minutes after consumption of Axona® at baseline and then again     after 45 days of treatment. Cognitive testing will also be conducted at baseline and day 45.   "
249544|NCT01122511|"     This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive     therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of     patients with choroidal neovascularization secondary to age-related macular degeneration   "
249545|NCT01122524|"     The primary objective of this study is to determine the performance characteristics     (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21)     compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).      Secondary objectives are to assess performance of the test to detect male gender (XY) and     other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45,     X)) compared to clinical fetal karyotype.   "
249546|NCT01122537|"     Meningitis is a rare complication following neurosurgical procedures and is associated with     high morbidity and mortality. The aim of this study is to describe the clinical     characteristics and microbiological characteristics in patients who develope meningitis     following neurosurgical operations, and investigate the useful tips for the differential     diagnosis of postneurosurgical meningitis.   "
249531|NCT01122342|"     Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes     thin and symptoms develop including vaginal itching, vaginal discomfort and dyspareunia.     These can significantly affect women's comfort, sexuality and quality of life.      Treatment for this condition includes estrogen given in pill form, commonly known as hormone     replacement therapy and local estrogen treatments, such as vaginal estrogen creams and     topical vaginal lubricants. Unfortunately, systemic estrogen is contraindicated in many women     with breast cancer. Some providers also feel that women who are taking aromatase inhibitors     for their breast cancer should also not use local estrogens as several small studies suggest     that these treatments might effect estrogen levels and thus might change how effective the     aromatase inhibitors are. If these women choose not to use any form of estrogen therapy there     symptoms may not be well controlled with other treatments.      The investigators hypothesize that a vaginal testosterone cream might be a safe and effective     alternative treatment for these women. This small study is intended to test the hypothesis     that testosterone cream will not increase estrogen (estradiol) levels and that it will     improve the symptoms of atrophic vaginitis including vaginal dryness, vaginal itching and     pain with intercourse.      The investigators will enroll women in the trial who are taking an aromatase inhibitor and     have the symptoms mentioned above. They will receive a testosterone cream which will be     applied vaginally once a day for 28 days. If good results are found with a prespecified dose     of testosterone, a lower dose will be tested in the next group of women enrolled.   "
249532|NCT01122355|"     The purpose of the study is to compare the efficacy and tolerability of fenofibrate 160 mg     and niacin 1500 mg in patients with hypertriglyceridemia and low HDL-cholesterol. The primary     end point is the percent change of apoB/A1 and the secondary end points are other lipid     parameters and biomarkers.   "
249534|NCT01122381|"     The purpose of this study is to determine whether ethosuximide works better than placebo in     the prevention of episodic migraine among veterans.   "
249535|NCT01122394|"     Adults who have had a previous stroke or transient ischemic attack (TIA) remain at risk for     having a second serious event, especially if they have uncontrolled blood pressure or     cholesterol. However, many patients have difficulty following treatment recommendations for     lowering blood pressure and cholesterol. The purpose of this research project is to evaluate     the effect of 2 booster sessions of an educational counseling intervention on how well adults     who have already participated in a 6-month clinical trial had a stroke or transient ischemic     attack (TIA) are able to follow a treatment plan and control their blood pressure and     cholesterol levels. We will also examine how effective this intervention is in improving     adherence to diet, medication, and physical activity recommendations for adults who have had     a prior stroke or TIA.   "
249536|NCT01122407|"     The overall goal of this proposal is to determine the autonomic and nitric oxide contribution     in the pathogenesis of hypertension and insulin resistance in obese African American women.     For this purpose we will use two non-FDA approved drugs:      Trimethaphan IND# 63826 Approval date 12/20/2001 L-NMMA IND# 41735 Approval date 09/1993   "
249537|NCT01122420|"     The purpose of this study is to determine whether different types of online health tools can     aid overweight individuals in reducing their weight and managing their cardiovascular risk     factors in the context of an employee wellness program.   "
249538|NCT01122433|"     The purpose of this study is to evaluate the C-MAC video laryngoscope in difficult airway     situations.   "
249539|NCT01122446|"     A double-blind, randomized investigator-initiated study to determine the safety and the     effect of Diamyd® on the progression to type 1 diabetes in children with multiple islet cell     autoantibodies      Eligible children are 4 years or older, have positive GAD-antibodies and at least one     additional autoantibody and not yet diabetes.      Objectives:      DiAPREV-IT is the first prevention study with Diamyd®, where the drug is given before onset     of type 1 diabetes.      The primary objective is to demonstrate that Diamyd® is safe in children at risk for type 1     diabetes.      The secondary objective is to evaluate if Diamyd® may delay or stop the autoimmune process     leading to clinical type 1 diabetes in children with ongoing persistent beta-cell     autoimmunity as indicated by multiple positive islet cell autoantibodies.   "
249540|NCT01122459|"     Avoiding nausea and vomiting is one of the most important for patient comfort and     satisfaction, and preventing unplanned overnight stays in hospital following surgery. Studies     have shown that increased amounts of intravenous fluid during surgery prevent nausea and     vomiting after operations. This effect lasted for up to 48 hours after the surgery. Other     unpleasant side effects of dehydration that delay recovery including headaches and dizziness     can be prevented with fluid treatment during the operation. It is unclear if this effect     happens with all types of fluid. The investigators propose to examine the effect of 2 types     of intravenous fluids on recovery from anaesthesia. Each group will be given a different     fluid while using our usual anaesthetic technique. The investigators will ask questions about     nausea and vomiting after surgery (primary outcomes), and other factors relating to patient     comfort such as headache and dizziness (secondary outcomes)   "
249541|NCT01122472|"     This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to     explore the effect of maintenance therapy with lenalidomide versus placebo on     progression-free survival (PFS) in patients treated with R-CHOP responding to induction     therapy      For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for     Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs     73.6%), is considered clinically relevant.   "
249542|NCT01122485|"     The objective of this study was to explore the efficacy, dose-response and safety of PG201     tablet in Korean patients with osteoarthritis.   "
249543|NCT01122498|"     Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be     consented, screened, and enrolled in the study if they meet all eligibility criteria. At the     time of open surgical repair, subjects who are randomized to receive the test article in     addition to the Standard of Care (SOC) will be hospitalized and have a single dose of     BMP-655/ACS surgically implanted at the site of tendon attachment to bone. Subjects who are     randomized to receive SOC alone will receive no test article. Following surgery, subjects     will be prescribed a rehabilitation plan. Subjects will then complete 9 follow-up visits     beginning 24 hours after surgery and continuing through 52 weeks.   "
249551|NCT01122602|"     The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of     fast release aspirin tablets, 650 mg (2 x 325 mg) compared to regular aspirin tablets, 650 mg     (2 x 325 mg) and placebo in subjects with postsurgical dental pain.   "
249552|NCT01122615|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of sunitinib and temsirolimus that can be given to patients with metastatic     kidney cancer.   "
249562|NCT01122745|"     1. Rotator cuff have painful post surgery recovery.        2. Single shot interscalene with oral analgesics may or may not be enough        3. Continuous nerve block may be too much for the surgery        4. The idea is to compare two techniques to see if the two techniques can improve patient          pain control and satisfaction.   "
249553|NCT01122628|"     The surgical treatment of wrist fractures (distal radius bone) has been changed by the     introduction of a new plate design, the locking plate. This results in improved fixation and     stabilisation of the fracture fragments allowing early movement.      This type of plate has been increasingly used throughout the world but questions have been     raised regarding the potential complications of the surgery, particularly nerve and tendon     injury. The Norfolk and Norwich Hospital has treated over 250 distal radial fractures with     this type of plate. The investigators plan to recall these patients to asses their long term     function, general satisfaction and radiological results.   "
249554|NCT01122641|"     Animal models have demonstrated that incretins have a glucose-independent effect on vascular     perfusion, and there is limited evidence that incretins may enhance endothelial function in     healthy subjects. Currently DPP-4 inhibition increases levels of the endogenous incretin     Glucagon-like Peptide 1 (GLP-1) and is licensed for the treatment of hyperglycaemia in type 2     diabetes. They are positioned as third or even fourth line therapy after metformin,     sulphonylureas ± glitazones, however recent analyses of cardiovascular outcomes in glitazones     and sulphonylureas suggest at best they do not reduce cardiovascular endpoints, and may     increase some outcomes. If the vascular benefits suggested in animal models are realised in     humans this should see the DPP-4 inhibitors moved to second line and possibly 1st line.      In order to realise the potential the investigators would like initially to demonstrate     increases in vascular perfusion and function in a placebo controlled trial using accurate     surrogates for vascular function in patients with insulin resistance and obesity.      The investigators hypothesis is that by increasing incretin activity in insulin resistant     states the investigators will lower capillary pressure and improve microvascular function,     which will be accompanied by a reduction in macular thickness (by reducing macular oedema)     and microalbuminuria, recognised surrogates for early diabetic retinopathy and renal failure     respectively.   "
249555|NCT01122654|"     This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant     formulas in healthy, term infants.   "
249556|NCT01122667|"     This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in     subjects with impaired renal function and healthy matched control subjects.   "
249557|NCT01122680|"     The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25     mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium     5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler     in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top     of maintenance therapy with an inhaled corticosteroid controller medication. It is a     randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over     design. Patients need to be still symptomatic, i. e. not fully controlled with their     maintenance treatment.   "
249558|NCT01122693|"     The use of ultrasound imaging techniques in regional anaesthesia is rapidly becoming an area     of increasing interest. It represents one of the largest changes that the field of regional     anaesthesia has seen. For the first time, the operator is able to view an image of the target     nerve directly, guide the needle under real-time observation, navigate away from sensitive     anatomy, and monitor the spread of local anaesthetic (LA).The key to successful regional     anaesthesia is deposition of LA accurately around the nerve structures.      In the past, electrical stimulation which relied on surface landmark identification, was used     for this. However, landmark techniques have limitations; variations in anatomy and nerve     physiology , as well as equipment accuracy have had an effect on success rates and     complications.      However, alongside the enthusiasm of ultrasound guidance in regional anaesthesia, there     should be a degree of informed scepticism. The widespread use of the various techniques of     ultrasound-guided regional blocks without adequate training raises the danger of malpractice     and subsequent impaired outcome.      Adequate education in the use of regional block techniques under ultrasound guidance is     essential. Recent technical developments have achieved higher ultrasound frequencies and     better image resolution, as well as better post-processing and user-friendliness.      The purpose of this study is to determine whether new technical features such as reference     images, higher ultrasound frequencies, better image resolution and smaller size and weight of     the ultrasound probes may improve outcome (clinical benefits) and may show an increased     efficacy and safety. And if the new technology of ultrasound images improves the training     quality of trainees and novices in the art of ultrasound-guided blocks.   "
249559|NCT01122706|"     Background: Excessive exposure to psychosocial stress can be a potent trigger for somatic     diseases and psychological disorders, a cause for missing work, and eventually lead to high     economic loss. Therefore, for health and economic reasons the assessment of effectiveness of     stress preventive interventions is of high relevance. According to several clinical studies,     Taiji, a Chinese form of mindful and gentle movements, can significantly reduce symptoms of     somatic diseases and psychological disorders. Some recently conducted Taiji-studies with     healthy subjects indicate a stress protective effect. However, the stress protective impact     of Taiji regarding psychosocial stress has not yet been examined.      Objective: To investigate the efficacy of a 12 week Taiji training as a stress prevention     program by measuring psychosocial stress reactivity in a laboratory setting, as well as the     subjective perception of stress and coping-resources in daily life of 70 healthy volunteers.      Hypothesis: Healthy subjects attending a 12 week Taiji course (frequency: twice a week for     1h) will show significantly reduced psychobiological reactivity, decreased stress perception     and increased coping-resources on a standardized psychosocial stress test compared with     healthy subject of the waiting list.   "
249560|NCT01122719|"     To evaluate the safety and efficacy of the Janus OPTIMA Tacrolimus-Eluting Stent (Optima TES,     CID) for the treatment of de novo coronary lesions when associated with short-term (two     months) dual antiplatelet (aspirin + clopidogrel) regimen.   "
249561|NCT01122732|"     1. Interscalene continuous catheter is a very effective way of controlling pain in total          shoulder arthroplasty. To ensure proper placement, nerve stimulating catheter is quite          often used.        2. Ultrasound can help proper placement of catheter without relying on nerve stimulation.        3. The plan of the study is to compare two techniques head to head to see if they are          equally effective or one is better than others.   "
249577|NCT01122940|"     Mexican healthy volunteers will receive the current form of the drug (under the name of     Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.   "
249563|NCT01122758|"     The research project CHAIN (COPD Assessment History in Spain): A Multidimensional Study on     the Evolution of Chronic Obstructive Pulmonary Disease (COPD)is a multicentre, observational     study conducted in several areas of Spain aimed to better define COPD natural history and its     phenotypes   "
249564|NCT01122771|"     This protocol will evaluate the efficacy and safety of various combinations of the three     drugs; AmBisome, Paromomycin and Miltefosine at reduced total dosage against the standard     treatment with a total dose of 15mg/kg of AmBisome.   "
249565|NCT01122784|"     Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at     a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four     parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts     (N=40 each) will be vaccinated at two different three-dose schedules (Days 0, 56 and 182 or     Days 0, 56 and 121).   "
249566|NCT01122797|"     Increasing evidence attests the influence of multiple metabolic genetic risk factors in the     progression of alcoholic liver disease. Deleterious pathways involved in metabolism such as     lipid peroxidation and cytokines have been implicated in promoting inflammation leading to     fibrosis increase and liver injury progression. The aim of this study was to assess the role     of rs738409 single nucleotide polymorphism in the PNPLA3 gene in alcoholic liver disease     patients.   "
249567|NCT01122810|"     Coronary vasculopathy remains the leading cause of decreased survival after the first year     post-transplantation. It is mainly asymptomatic because of the denervation of the heart     transplant. Currently, annual invasive coronary angiogram is performed to ensure the lack of     coronary narrowing. But invasive coronary angiography caries risks of serious adverse events     and some concern rise from its repetition in that population. Recent advance in coronary     multidetector computed tomography (CT) may allow non invasive visualization of the coronary     tree. But, it remains unknown if the encouraging data observed in native coronary artery     analysis can be extrapolated to transplant heart recipients. Indeed, only very small sample     size studies (20 patients) have been conducted in this particular setting. Thus, the     investigators decide to assess the diagnostic accuracy of the 64-row CT and 256-row CT     compared to the gold standard coronary angiogram in a larger sample size study. The practice     aim of this study is to determine if the conventional invasive coronarography can be switched     by the 64-row CT or the 256-row CT to assess coronary anatomy especially for the patient     without any coronary artery disease (CAD) or those with CAD not suitable for percutaneous     coronary intervention.   "
249568|NCT01122823|"     The purpose of this study is to learn if Group Health members who participate in the online     chronic disease self-management program will experience improved health outcomes, improved     health care utilization, and lower costs.   "
249569|NCT01122836|"     This study is designed to determine the most effective dose of massage for persons with     chronic neck pain. This information is necessary before more definitive studies can be     conducted.   "
249570|NCT01122849|"     The purpose of this exploratory study is to evaluate the subjective measures of congestion     and sleep quality in subjects who suffer from chronic nasal congestion and report trouble     with their sleep.   "
249571|NCT01122862|"     A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth   "
249572|NCT01122875|"     This is a multicenter, open-label, dose-escalation study of MFGR1877S in patients with     relapsed or refractory t(4;14)-positive multiple myeloma.   "
249573|NCT01122888|"     This clinical trial is studying how well giving cilengitide together with sunitinib malate     works in treating patients with advanced solid tumors or glioblastoma multiforme. Cilengitide     and sunitinib malate may stop the growth of tumor cells by blocking blood flow to the tumor.     Giving cilengitide together with sunitinib malate may kill more tumor cells. Studying samples     of blood in the laboratory from patients receiving cilengitide and sunitinib malate may help     doctors understand the effect of these drugs on biomarkers.   "
249574|NCT01122901|"     This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor     RO4929097 works in treating patients with recurrent or progressive glioblastoma.     Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
249590|NCT01123109|"     The purpose of this research study is to measure the muscles that make up your anal sphincter     (muscles that control bowel movements) by using ultrasound. The most common way for women to     injure these muscles is through childbirth. Some physicians think about 30% of women     delivering their first baby develop some anal sphincter damage, which may or may not lead to     symptoms such as anal urgency or incontinence (involuntary loss of gas or stool). The purpose     of the study is to measure muscles in normal women who have never given birth or had an     injury to their anal sphincter.   "
249591|NCT01123122|"     Islet transplants for those with type 1 diabetes have enabled many to initially eliminate     insulin, however, only a fraction of the transplanted cells typically survive and the     functioning of these decrease over time. As a result, most patients will eventually require     some insulin. Currently, the cause of this poor survival and decrease in function is not     understood; although previous research has demonstrated that even a slightly elevated level     of blood glucose can impair islet function. This study will determine if strict blood glucose     control at the time of islet transplantation, when the cells are the most fragile, will     improve the survival and functioning of transplanted islet cells three months after     transplantation.   "
249575|NCT01122914|"     Background:        -  Severe atopic dermatitis, also known as eczema, is a chronic inflammatory skin condition          that affects both children and adults and causes severe itching and skin redness.          Current treatments of atopic dermatitis include topical creams and lotions, light          therapy, and medications. However, the difficulty with long-term treatment for the          chronic and severe nature of the disease requires more effective and better-tolerated          therapeutic options.        -  Anakinra is a drug that blocks a substance called interleukin-1 (IL-1), which may be          important in causing the inflammation in atopic dermatitis. Researchers are interested          in determining whether anakinra can be used to help treat atopic dermatitis. Anakinra          has been approved by the Food and Drug Administration to treat rheumatoid arthritis in          adults and children, but it has not been approved for use in adults or children with          atopic dermatitis and is considered an experimental treatment in this study. In this          study Anakinra will be administered as an injection under the skin every day for 3          months      Objectives:      - To assess the safety and effectiveness of using anakinra to treat severe atopic dermatitis     in children.      Eligibility:      - Children between 10 and 18 years of age who have been diagnosed with severe atopic     dermatitis that has not responded to standard treatment.      Design:        -  Initial Screening: Participants will have an initial screening visit with a complete          physical examination and medical history, blood and urine tests, photographs of the skin          ,skin biopsy, and other tests as required.        -  Run-in Period: At the screening visit, participants will receive a diary card and will          be asked to track their atopic dermatitis symptoms on standard treatment for 2 months.        -  Start of Treatment: At the end of the 2 month Run-in period participants will return for          an inpatient visit (2 days) to receive the initial dose of anakinra and will be watched          for any side effects. During the inpatient visit, participants will have additional          examinations and blood and urine tests, and will be instructed on how to administer the          anakinra injections at home.      Treatment Period: - Participants will return once a week for the first 2 weeks of treatment,     at the end of the first month, and then once a month for the following 2 months, for a     physical exam and blood tests. Participants will be asked to record symptoms related to their     atopic dermatitis, anakinra administration and any side effects related to the anakinra on     the diary card. The diary cards will be reviewed and collected at each visit.-      End of Treatment Period: At the end of 3 months of treatment with anakinra, participants will     again be asked to record symptoms related to their atopic dermatitis on the diary card.     Participants will be seen once a month for 3 months for a physical exam, blood tests and     review of the diary card. . The final study visit will take place at the end of the 3rd month     and will include a physical exam, blood tests, photographs and skin biopsy.   "
249576|NCT01122927|"     This is an open-label study consisting of a screening period, a conversion/titration phase     (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.      The study will enroll new subjects (hereafter referred as de novo subjects) with     schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic     features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as     Study 266). All de novo subjects must enter the screening period of the study. Subjects who     are screened and are not required to go through Phase 1 will complete a Phase 2 baseline     visit prior to their participation in Phase 2.      Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy     Study   "
249580|NCT01122979|"     Primary Objective:      >To obtain an estimation for both treatment groups of the proportion of patients that reach     the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group.      Secondary Objectives:        -  Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and          after each period of treatment.        -  Incidence of confirmed symptomatic and nocturnal hypoglycemia.        -  Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover).          >Weight variation for each period of treatment.        -  Creatinine clearance at baseline and after each period of treatment.        -  Overall safety: Incidence of adverse events.   "
249581|NCT01122992|"     The main purpose of this study is to evaluate the use of limbal relaxing incision (LRI) for     astigmatic correction. LRI is a procedure where a pair of incisions is made in the peripheral     part of the cornea so as to alter its shape and improve the focusing power of the eye.   "
249582|NCT01123005|"     We hope to find safer, noninvasive methods for measuring tumor hypoxia. Hypoxia, meaning a     lack of oxygen, has been associated strongly with a wide range of human cancers. Hypoxia     occurs when tumor growth exceeds the ability of blood vessels to supply the tumor with     oxygenated blood. It is currently understood that hypoxic tumors are more aggressive. Current     methods for measuring hypoxia include invasive procedures such as tissue biopsy, or insertion     of an electrode into the tumor. EF5-PET may be a non-invasive way to make this measurement.   "
249583|NCT01123018|"     We hope to recruit participants into various clinical trials and research projects.   "
249584|NCT01123031|"     A bleeding peptic ulcer remains a serious medical problem with significant morbidity and     mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality     in patients with bleeding peptic ulcers and is now recommended as the first hemostatic     modality for these patients.      In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after     endoscopic therapy has been endorsed in some studies. Laine and Javid et al found that oral     PPI and IV PPI had a similar intragastric pH response in the past two years. Therefore,     whether oral can replace IV in the management of peptic ulcer bleeding is the objective in     this study.      The investigators enrolled 130 patients with active bleeding or nonbleeding visible     vessels（NBVV） in this study. They are randomly assigned as oral lansoprazole or IV nexium     group. All patients receive successful endoscopic therapy with heater probe or hemoclip     placement.      In the lansoprazole group (N=65), 30 mg four times daily is given orally for three days.     Thereafter, the patients receive 30 mg lansoprazole orally daily for two months. In the     nexium group, 160 mg/day continuous infusion is given for three days. Thereafter, the     patients receive 40 mg nexium orally daily for two months.      The primary end point is recurrent bleeding before discharge and within 14 days. At day 14,     volume of blood transfused, number of surgeries performed, and the mortality rates of the two     groups are compared as well.   "
249585|NCT01123044|"     The aim of the study is to assess if transplantation of cultivated corneal epithelial stem     cells could restore vision in patients with severe ocular surface disorder with a favourable     safety profile that warrants further comparative study.   "
249586|NCT01123057|"     This is a hospital-based interventional prospective study. Patients with clinical keratoconus     or LASIK keratectasia presenting to the Singapore National Eye Centre who meet the     eligibility criteria are recruited for this study. The aim of the study is to assess the     safety and efficacy of riboflavin-UVA induced cross-linking treatment for corneal ectasia   "
249587|NCT01123070|"     The purpose of this study is to determine the safety and pharmacology of TL011 in patients     with severe rheumatoid arthritis.   "
249588|NCT01123083|"     DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective     is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in     insulin secretion as compared with placebo. Insulin secretion will be assessed using mixed     meal-stimulated C-peptide.      Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3     otelixizumab, 1/3 placebo). These study agents will be administered as an addition to     insulin, diet, and other standard of care treatments.   "
249589|NCT01123096|"     The purpose of this research study is to identify if the cough stress test is equal to the     24hour pad test in assessing stress urinary incontinence.   "
249592|NCT01123135|"     This is a randomized, double blinded placebo controlled trial over a period of 3 months.     Study subjects will be randomized into 2 groups: Those receiving drug (1gm of estrogen     vaginal cream [EVC] at bed time 3 times a week), and those receiving placebo.   "
249593|NCT01123148|"     The investigators want to develop a brain-computer interface (BCI) that will eventually allow     people who are completely paralyzed to independently control the tilt feature on their power     wheelchairs. This study will allow healthy volunteers to test the feasibility and accuracy of     controlling a BCI using only their brain signals while seated in a tilting wheelchair.   "
249594|NCT01123161|"     The purpose of this trial is to determine whether the combination of thrombolysis and     hypothermia is superior to thrombolysis alone for the treatment of acute ischemic stroke.   "
249595|NCT01123174|"     The suicidal behaviors are phenomena eminently multifactorial. It is thus always difficult to     define univocal strategies of prevention of suicide repetition, during the emergency stay,     i.e. almost in general population. One find 23 clinical trials in this topic in the past 25     years, and 18 are negative. The majority of the positive trials have the concern of being     dissociated from an assumption of responsibility of care strictly speaking, to adopt a     position méta, nearer to the concept of case management: how to remain in contact with     the suicide attempter, without forcing it in this every day life, replacing a possible     proposing, but assumption of responsibility resources reliable and quickly accessible in the     event of at risk situation? Each one of these studies tests devices which seem more     appropriate to such or such characteristic of this population, by retaining only simple     criteria like the sex, the number of former suicide attempts, the proposal or not for an     assumption of responsibility of care, the observance or not with the plan of care. Thus, it     would seem interesting to combine these approaches in an algorithm entitled ALGOS.      Main aim: To test the effectiveness of this algorithm of case management, named ALGOS, in     reducing the number of death by suicide, in terms of reduction of suicide re-attempts and the     number of loss of contact patients in the ALGOS group during 6 months period, compared to a     control group of suicide attempters treated as usual (i.e. primarily transmitted to the     attending physician).      Secondary objectives: To evaluate, according to the method validated by Beecham in 1992,     direct medico-economic impact in the year which follows the introduction of algorithm ALGOS.     Reduction of the other suicidal behaviors in 6 months (reduction in the full number of     suicidal repetitions in each group, evolution of the score of suicidal ideation, etc…). To     evaluate the effect of the algorithm, at the 13th month. To study the possible differences     within the time in terms of suicidal repetitions in the 2 groups. To propose different     profiles of answers according to psychopathology, the number of suicide attempts, suicidal     character, the sex,…      Methodology: Comparative simple blind prospective multicentric controlled study   "
249596|NCT01123187|"     This single center phase 2 clinical trial, is designed for confirming the efficacy and safety     of sequential islet allotransplantation with steroid free immunosuppression in patients with     previous kidney transplantation.   "
249597|NCT01123200|"     The investigators are developing a tool to help people who are severely paralyzed. This tool     is called a brain-computer interface (BCI). BCIs can connect to computers or other electronic     devices.      This study allows a person with ALS to communicate, control their wheelchair tilt and perform     other tasks using a BCI, thus increasing their independence.   "
249598|NCT01123213|"     Pessaries are mechanical support devices worn vaginally to treat the symptoms of pelvic organ     prolapse, such as vaginal pressure or a vaginal bulge. Pessaries are one of the options along     with surgery and expectant management for pelvic organ prolapse. As the aging population     grows, more patients will need treatment for pelvic organ prolapse. Various studies have been     conducted previously to identify patient parameters predictive of successful pessary fitting     and continued use. Our study is a retrospective chart review to identify patient     characteristics predictive of successful pessary fitting and use, specifically focusing on     the parameters of POPQ, pelvic organ prolapse quantification exam, and the ratio of the     genital hiatus, which is the length of the vaginal opening, and total vaginal length.   "
249599|NCT01123226|"     There will be no difference between trigger point therapy and spinal manipulation in     correcting a spine joint dysfunction in the back   "
249600|NCT01123239|"     In this study, we are testing the effectiveness of an intervention known as Coached Care to     improve health outcomes and quality of care of patients being treated for type 2 diabetes,     particularly patients in underserved populations. The intervention involves training members     of minority communities who have diabetes to be coaches, teaching minority patients the     skills needed to participate effectively in care during office visits, as they present for     those visits. Coaches follow patients for 9 routine consecutive visits, reinforcing     participation skills before and between their routine office visits.   "
249601|NCT01123252|"     The study aims to examine the effect of probiotics on the clinical symptoms of allergic     rhinitis and to elucidate some of the immunological mechanisms involved.   "
249602|NCT01123265|"     The purpose of this study is to determine whether DC-STAMP, a protein on the surface of     osteoclast precursors (OCPs), can be used as a biologic marker in Psoriatic Arthritis (PsA).     With this marker the investigators hope to learn more about how OCPs develop as well as find     out if DC-STAMP predicts PsA severity and how well treatment works in PsA.   "
249603|NCT01123278|"     Hypogonadism (HG) frequently complicates the Metabolic Syndrome (MetS), whether testosterone     replacement (TRT) is beneficial has not been clearly ascertained. This study was designed to     address the effects of TRT on insulin resistance, body composition and pro-inflammatory     status in naïve patients with MetS and HG.   "
249604|NCT01123291|"     The purpose of this study is to evaluate the long term clinical impact of routine follow-up     coronary angiography after percutaneous coronary intervention (PCI). The primary endpoint is     a composite of death/myocardial infarction/stroke/emergency hospitalization for acute     coronary syndrome/hospitalization for congestive heart failure at 3-year after percutaneous     coronary intervention.   "
249605|NCT01123304|"     This research is being done to find out the safety of MORAb-028 in subjects with metastatic     melanoma.   "
249606|NCT01123317|"     The purpose of this study is to assess how oxytocin delivered intranasally changes regional     brain blood flow measured by positron emission tomography (PET) in conjunction with oxygen-15     labeled water in persons with schizophrenia. The objective is to better our understanding of     oxytocin's role in the modulation of social judgment in schizophrenia and provide more     information as to potential uses of oxytocin or a similar drug analog in treating certain     features of schizophrenia and other neuropsychiatric disorders.   "
249724|NCT01123980|"     This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood     sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine     once daily both in combination with metformin and glimepiride in Chinese and Japanese     subjects with type 2 diabetes who have never received insulin before.      The trial is conducted as a phase 4 trial in China and phase 3 in Japan.   "
249618|NCT01123473|"     RATIONALE: Drugs used in chemotherapy, such as epirubicin hydrochloride, cisplatin,     fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not     yet known whether giving combination chemotherapy together with or without lapatinib     ditosylate is more effective in treating patients with cancer of the stomach or     gastroesophageal junction.      PURPOSE: This randomized phase II trial is studying how well epirubicin hydrochloride,     cisplatin, and fluorouracil or capecitabine works when given together with or without     lapatinib ditosylate as first-line therapy in treating patients with stomach cancer or     gastroesophageal junction cancer.   "
249642|NCT01123798|"     The purpose of this study is to define the reliability and accuracy of Near Infrared     Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and     noninjured extremities over time. The investigators hypothesize that this technology,     combined with vital signs, intracompartmental pressures and clinical examinations, will be     useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS,     and evaluating the adequacy of fasciotomy in patients treated for ACS.   "
249607|NCT01123330|"     The Detroit Dental Health Project (DDHP)aims to promote oral health and reduce disparities     within the community of low-income African-American children (0-5 years) and their main     caregivers (14+ years), living in the City of Detroit. The driving theme of the Project is to     identify determinants and design interventions to answer the following question: why do some     low-income African-American children and their main caregivers have better oral health than     others who live in the same community? The Project has 3 support cores, 4 research core     projects and 1 pilot study. The Project has selected a multistage random sample of     African-American families living in the poorest 39 Census Tracts in the City of Detroit. A     total of 1,022 families were recruited and interviewed at a community center in Detroit     during the year 2 (2002). We have collected data about the social characteristics of parents,     families, and neighborhoods that are associated with disparities in oral health; lead levels     in saliva and blood of the caregivers; and dietary intake. All these families will be     recalled in the year 4 (2004) and year 6 (2006) for longitudinal data collection. We are     currently developing a tailored multi-media educational intervention (Project #3), based on     data collected in the first phase (2002). The educational intervention will be administered     using a randomized controlled design in year 4 (2004). Additionally, the Project is     evaluating the impact on access to dental care of a state-funded experiment on utilization     where Medicaid children are managed like privately insured patients (Project #4).   "
249608|NCT01123343|"     To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR     MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing     information during cataract or refractive lens exchange surgery. Device images, safety     results and surgeon questionnaire will demonstrate that the TrueVision system provides clear     images to assist surgeons during LRI or capsulorhexis procedures.   "
249609|NCT01123356|"     The purpose of this research is to evaluate the safety and effectiveness of the drugs     lenalidomide and ofatumumab in the treatment of chronic lymphocytic leukemia (CLL).   "
249610|NCT01123369|"     To determine the retinal and choroidal thickness in patients with sickle cell disease     compared to age, race matched population without sickle cell disease to allow a better     understanding of the clinical manifestations of sickle cell retinopathy. The purpose of this     research study is to evaluate the relationship between sickle cell disease and the eye. The     research study is recruiting African American population with or without Sickle Cell Disease.     The investigator in charge of this study is Dr E. Bowie. Approximately 60 subjects of both     sexes will be enrolled at the Medical University of South Carolina.   "
249611|NCT01123382|"     Post-stroke shoulder pain is a major rehabilitation problem affecting moderate to severely     impaired stroke survivors. Surface electrical stimulation (ES) of muscles surrounding the     hemiparetic shoulder has been demonstrated to be beneficial, but despite the evidence for     therapeutic benefit, the clinical implementation of surface ES for poststroke shoulder pain     has been difficult. In order to address the limitations of surface ES, the investigative team     pioneered the development of percutaneous intramuscular (IM) ES for the treatment of     post-stroke shoulder pain. However, prior to acceptance by the clinical community, additional     gaps in the scientific and clinical knowledge need to be addressed. This study begins to do     so. The primary objective is to estimate the relative pain reduction associated with IM ES     vs. usual care. We hypothesize that the IM ES group will exhibit a larger effect size with     respect to pain reduction compared to usual care. A secondary objective is to estimate the     effect on health related QOL of IM ES vs. usual care. Demonstration of improvement in QOL     will validate the clinical relevance of the intervention. We hypothesize that the IM ES group     will exhibit greater improvement in health related QOL compared to usual care.   "
249612|NCT01123395|"     The purpose of this study is to evaluate and compare the relative bioavailability of a single     0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice     relative to the same dose given as an intact tablet to healthy subjects following an     overnight fast.   "
249613|NCT01123408|"     This was a double-blind randomized study with three treatment arms: clozapine, olanzapine and     haloperidol. We compared these three medications in the treatment of aggressive behavior over     a 12 week period.   "
249614|NCT01123421|"     Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of     osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS     parameters will be able to discriminate between postmenopausal women with osteoporotic     fractures when compared to matched controls without history of osteoporotic fracture.   "
249615|NCT01123434|"     The primary objective is to assess the efficacy of immediate postoperative adjuvant hormonal     treatment according to 2 year PSA recurrence rate in high risk localised or locally advanced     Chinese prostate cancer patients.The secondary objective is to assess the quality of     life（QoL）of the high risk localised or locally advanced Chinese prostate cancer patients with     immediate postoperative adjuvant hormonal treatment and get the information of immediate     postoperative adjuvant hormonal treatment (including the regimen, dosage and duration).   "
249725|NCT01123993|"     To determine the effect of Thai traditional music on cognitive function, psychological health     and quality of sleep among Thai older individuals with dementia.   "
249616|NCT01123447|"     The purpose of this study is to determine if surgery using a plate and screws to fix a     forearm fracture (ulnar shaft) will improve functional outcome compared to non-operative     treatment out to 1 year of follow-up. It is hypothesized that in skeletally mature patients     with isolated ulnar shaft fractures, the patients treated with surgery will have improved     functional outcomes compared to non-surgical treatment with below-elbow cast at 1-year     follow-up. This will be measured by the Disabilities of the Arm, Shoulder and Hand (DASH)     scores. Secondary outcomes will include SF-36, range of motion, pain, grip strength, return     to work, and time to union.   "
249617|NCT01123460|"     RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib     hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on     cells. It may also help doctors understand how well patients respond to treatment.      PURPOSE: This research study is studying biomarkers predicting response in patients with     non-small cell lung cancer previously treated with erlotinib hydrochloride.   "
249640|NCT01123772|"     The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye     drops at different concentrations to normal older healthy adult volunteers for two weeks.   "
249641|NCT01123785|"     The purpose of this study is to evaluate how tolerable, safe, and effective it is to give     INO-8875 eye drops to adults with glaucoma or ocular hypertension.   "
249619|NCT01123486|"     The primary objective of the proposed work is development of a high resolution     pharmacokinetic-pharmacodynamic (PK-PD) model of hydromorphone for experimental pain stimuli,     ventilatory depression, and surrogate biomarkers of opioid effect that will allow the     fingerprinting of hydromorphone. This fingerprint will serve as the basis for the development     of dosing strategies that efficiently maximize analgesia while minimizing ventilatory     depression and sedation. For example, this high-resolution fingerprint will allow precise     estimation of an initial hydromorphone target effect site concentration (Ce) from those of     effectively administered synthetic opioids with previously determined high-resolution     fingerprints (i.e., remifentanil or fentanyl), thereby minimizing underdosing of     hydromorphone for analgesia and minimizing side effects.   "
249620|NCT01123499|"     Background:        -  Many treatments for immune system disorders involve the use of stem cells that have been          collected from blood marrow. To obtain these stem cells without surgery, individuals          receive granulocyte colony-stimulating factor (G-CSF) to encourage the production of          stem cells that can be collected through blood donations. However, not all patients or          normal donors respond to G-CSF alone.        -  Plerixafor, recently approved by the Food and Drug Administration, is different from          G-CSF but also allows stem cells to be collected from donated blood. However, more          research is needed on the quality and viability of the stem cells collected after using          both G-CSF and plerixafor.      Objectives:      - To collect and study the blood cells produced after treatment with G-CSF and plerixafor in     healthy volunteers.      Eligibility:      - Healthy volunteers between 18 and 65 years of age who are eligible to donate blood.      Design:        -  Participants will be screened with a medical history, physical examination, and initial          blood tests.        -  At the start of the study cycle, participants will receive daily morning injections of          G-CSF for 5 days. These may be given at the clinical center or by the participant after          teaching, depending on the participant s preference.        -  On the morning of Day 4, participants will visit the clinical center to provide a blood          sample after the injection. On the evening of Day 4, participants will receive an          injection of plerixafor.        -  Participants will have the final injection of G-CSF on the morning of Day 5, and will          provide another blood sample.        -  On Day 5, participants will have apheresis to separate the stem cells from the rest of          the blood. The apheresis may take up to 5 hours to complete.        -  The study will end after a follow-up phone call 7 to 14 days after the apheresis          procedure.   "
249621|NCT01123512|"     The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF     Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic     vertebral compression fractures of the thoracic or lumbar spine.   "
249622|NCT01123525|"     60 elective patients for CABG will be included to receive either standard hyperkalemic     cardioplegia (St.Thomas Hospital Solution No I) or cardioplegia where supranormal potassium     is replaced with 1.2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal     potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead     of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The     patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive     blood samples to measure release of cardiac enzymes.   "
249623|NCT01123538|"     The purpose of this study is to compare combined postmenopausal hormone therapy natural     progesterone to the one containing synthetic progestagen (i.e. chlormadinone acetate) at the     blood transcriptome level.   "
249624|NCT01123551|"     In the emergency department, 60% of patients have an acute pain. Appropriate management of     acute pain is a public health priority according to who recommendations. Nebulized morphine     has been extensively studied in children but less well in adults.      It offers a non-invasive route for systemic drug delivery, more rapid and less invasive than     intravenous (IV) method.   "
249625|NCT01123564|"     This study aims to assess if Lucentis injection applied into the eye is superior to     conventional treatment concerning the prevention of visual loss in patients having clinically     significant macular edema secondary to retinal vein occlusion   "
249626|NCT01123577|"     Background:      Hypertension (HTN) is a major risk factor for cardiovascular disease (CVD), the leading cause     of death in the United States and New York City (NYC). One in 4 NYC adults has hypertension,     with higher prevalence in both Blacks and Latinos compared to Whites (Angell 2008). In NYC,     only 65% of all adults with HTN and on treatment are controlled (Angell 2008).      Self-blood pressure monitoring (SBPM) is associated with reduced blood pressure in patients     with hypertension (Cappuccio 2004). Studies suggest that SBPM may increase control either by     inducing clinicians to titrate medication more actively, (Agency for Healthcare Research and     Quality 2002) by engaging patients to participate in their own health care, (Taylor 2007) or     a combination of the two.      However, minimal research has been done to evaluate the effectiveness of SBPM in different     racial and/or ethnic groups or in low income populations or to discern effective patterns of     SBPM use by patients. Best practices for integration of self monitoring into HTN into regular     treatment have also yet to be established.      Objectives:      The goal of this study is to assess the impact of SBPM under conditions consistent with     existing community health clinic resources and infrastructure in NYC's medically underserved     neighborhoods using commonly available automated home BP monitors. By using a community     clinic's electronic health record (EHR) and automated BP monitors with the capability to     transmit readings to a research database, we can facilitate a more rigorous evaluation of a     pilot SBPM intervention and assess patterns of home monitor use and clinical management and     their association with outcomes.      The three specific aims of this intervention are to:        1. Assess whether use of SBPM reduces elevated BP and increases HTN control to similar          levels in two historically understudied minority populations, Blacks and Latinos.        2. Confirm pilot findings by assessing the impact of SBPM on BP and HTN control compared to          usual care using randomized controlled trial methodology.        3. Develop standards and refine guidance for the effective use of SBPM that can be easily          communicated to key stakeholders.   "
249627|NCT01123590|"     The purpose of this study is to study characteristics of patients with thymoma in     Chulalongkorn hospital between 2003-2007.   "
249726|NCT01124006|"     Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early     lumbar disc degeneration   "
249628|NCT01123603|"     To the investigators knowledge there is no research data published to date regarding the     lower urinary tract symptoms in women with leiomyomas. The primary aims of this study are:        1. To determine prevalence of lower urinary tract symptoms in patients who present for care          for symptomatic leiomyomata.        2. To compare change in lower urinary tract symptoms within treatment groups measured by          the UDI-6 total before and at six months after three common treatments for symptomatic          uterine fibroids including: hysterectomy, myomectomy, or uterine artery embolization.      The study proposed here will hopefully answer the question if one particular therapy is     appropriate to treat fibroids and relieve lower urinary tract symptoms.   "
249629|NCT01123616|"     After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal     surgeries. The goal of the investigators randomized, prospective, multicentric,     internet-based study is to compare rate of SSI after surgery of colon and rectum by using     triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are     involved in this study. Two arms are separeted by computer randomization at abdomial wall     closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).     Triclosan is an antiseptic material which the investigators hope will provide better local     infection control at the site with reducing the risk of bacterial colonisation.   "
249653|NCT01117454|"     The purpose of this study is to test whether the addition of oral flecainide to standard     therapy will reduce ventricular ectopy on exercise test compared to placebo plus standard     therapy in patients with Catecholaminergic Polymorphic Ventricular Tachycardia.   "
249630|NCT01123642|"     Functional recovery is of the utmost importance to evaluate in our returning Operation     Enduring and Iraqi Freedom Veterans so that we can better understand their needs and     experiences during the readjustment process from warzone to civilian life. Although most     soldiers are resilient, concerning rates of PTSD (12-20%) and depression (14-15%) have been     found, and as many as 24-35% report drinking more alcohol than they intended (Hoge et al.,     2004). The current study proposes to follow returning Veterans for a one-year period to     evaluate factors that influence the readjustment process and functional impairment. This     information should guide the development of early intervention and treatment programs to help     recovery.   "
249631|NCT01123655|"     This is a Phase I clinical trial to determine whether orally administered APL A12 at one or     more doses is superior to placebo in effecting a 25% reduction in interferon (IFN)     stimulation index in 1(II)-stimulated culture of peripheral blood mononuclear (PBMC) obtained     from patients with Rheumatoid Arthritis (RA), which will be the primary outcome variable. In     an effort to learn more about the mechanism of action of APL A12, the investigators will     assess Th1/Th2/Th3 cytokine production in supernatants from 48h and 144h cultures of PBMC     stimulated by 1(II) and by APL A12 above. The investigators will assess function of CD4+     CD25+ T regs to determine whether APL A12 improves their suppressive function. Flow cytometry     combined with intracellular cytokine staining will be used in an effort to determine which T     cell subset(s) is/are experiencing shifts in cytokine expression.   "
249632|NCT01123668|"     The purpose of this study is to evaluate how nicotine, withdrawal from nicotine, and     methylphenidate (a drug used for the treatment of ADHD) affect the brain of smokers with and     without ADHD while doing tasks in an functional Magnetic Resonance Imaging scanner.      Study Hypotheses:        1. compared to non-ADHD smokers, smokers with ADHD will exhibit greater abstinence-induced          decrements in response inhibition performance and reward and greater concomitant          disruptions of brain activity        2. administration of MPH to abstinent smokers will ameliorate response inhibition          performance and reward deficits and task-related brain activation and this effect will          be greater among ADHD smokers        3. genetic markers of dopamine neurotransmission will moderate abstinence- and MPH -          induced changes in task-related brain activation across tasks.   "
249633|NCT01123681|"     The purpose of this study is to determine how often ventilator associated pneumonia happens     in the current intensive care units, and how types of endotracheal tube affect its     occurrence.   "
249634|NCT01123694|"     Xeroderma Pigmentosum (XP) is a rare skin condition that causes extreme sensitivity to the     sun and an increased incidence of skin cancers. The purpose of this study is to find out more     about XP patient experiences and their quality of life.   "
249635|NCT01123707|"     This will be a multicenter, 52-week, open-label study designed to assess the safety and     tolerability of an oral aripiprazole/escitalopram combination therapy in outpatients with     major depressive disorder (MDD). Enrollment into the study will be from eligible subjects who     have completed participation in Protocol 31-08-255, 31-08-256, or 31-08-263 (rollover     subjects).   "
249636|NCT01123720|"     Recently The Department of Health of Taiwan has launched the Internationalize Medical     Services Flagship Program, expecting to promote Taiwan's high-quality of medical services to     the international market, and anticipating customers stroll in, medical services walked     out.      In order to avoid expansion of this program might alienate the rights and best interests of     local people seeking medical services, therefore, this research project is a join effort of     experts to form an advisory counsel; by collecting most current international medical     services data; then using both qualitative and quantitative questionnaires to investigate     whether by implementation of internationalize medical services will cause great impact on     local people.      To study the various of insurance income of health care organization after they promote     international medical services; and to understand the impact of assess to medical care and     quality of medical services to local people due to internationalize medical services.      The last through advisory counsel, to make specific recommendations on mechanism of     management and to set evaluation of indicators to monitor international health care, to avoid     edge out local people the right of seeking medical care to ever happened, and to aid future     planning of policy and implementation.   "
249684|NCT01117857|"     The primary objective of the study is to determine if an eight-week intervention with     duloxetine significantly reduces depressive symptoms in symptomatic menopausal women. It is     hypothesized that an eight-week trial with duloxetine promotes significant improvement in     depression symptoms in menopausal women. The secondary aim of the study is to examine if an     eight-week intervention with duloxetine significantly reduces vasomotor symptoms in     symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine     promotes significant improvement in vasomotor symptoms in menopausal women.   "
249637|NCT01123733|"     This project aims to analyze and compare the prevalence of breastfeeding at one hour after     delivery, discharge from hospital, one month, two months, four months, and six months after     delivery and to examine factors associated with breastfeeding between baby-friendly hospitals     and non baby-friendly ones. Employing a prospective cohort design, the study population is     mothers who gave lived births in Taiwan area from August, 2009 to March, 2010. At least 11     hospitals both in non baby-friendly and baby-friendly hospitals from northern, middle,     southern and east areas will be asked for permission to join this study (totally 22     hospitals). The research assistants will contact each eligible participant in the hospitals     and explained the purposes and procedure of the study. Once permission was obtained, mothers     will be asked to write a questionnaire and their telephone numbers as well as address for     future contacts. After the individual case returned home, the collection of data was mainly     via telephone interviews. However, if the individual case could not be contacted more than     two times via telephone, she would be surveyed by questionnaire. The collection of data     showed the state of mother milk feeding one month, two months, four months, or six months     after delivery. 1, 000 effective questionnaires were expected to be returned (500 ones from     baby friendly hospitals; 500 ones, from non baby-friendly hospitals.) The survey include     questions on breastfeeding experiences (one hour after delivery, discharge from hospital, one     month, two months, four months, and six months), planned duration of breastfeeding,     socio-demographic information, perceived baby-friendly practices at hospital, social support     regarding breastfeeding, prior infant feeding method, maternal and infant health conditions,     mother's working plan, receipt of formula samples and commercial message during perinatal     period. The researcher hopes that based on the research results we can have a better     understanding of the influencing factors of promoting mother milk feeding in non     baby-friendly hospitals, and that we know how to raise the breastfeeding rate in Taiwan area,     which can serve as references for the governmental policies.   "
249638|NCT01123746|"     Objective: To evaluate the predisposing factors associated with abnormal laboratory findings     in patients who came to the emergency room due to a first seizure.      Methods: Patients were divided into separate groups based on normal and abnormal laboratory     results for sodium, potassium, calcium, and glucose. The difference in age, gender, whether     this was the first attack, whether there was fever, whether there were gastrointestinal     symptoms, the duration and pattern of the seizure, and whether there was a seizure at the     emergency department, were evaluated.   "
249639|NCT01123759|"     Fish can provide pregnant women with omega-3 fatty acids for fetal brain development but some     fish contains high levels of mercury which is detrimental to fetal brain development. The     hypothesis is that women who have previously consumed high mercury fish can reduce the     mercury level in their bodies and improve their omega-3 levels in three months by eating fish     that is high in omega-3 fatty acids and low in mercury.   "
249643|NCT01123811|"     Based on the current promising results with irinotecan and cetuximab in patients with     recurrent metastatic colorectal cancer, and the excellent results of Irinotecan and 5-FU in     gastric cancer , the present clinical study to evaluate the overall response rate, the time     to progression and the overall survival of the combined treatment of cetuximab and irinotecan     and 5-FU in patients with esophagogastric cancer is urgently needed.   "
249644|NCT01123824|"     Primary Objective:        -  Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate          (ADP)-induced platelet aggregation after administration of a standard dose regimen of          clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and          female subjects      Secondary Objectives:        -  Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg          loading dose followed by 150 mg/day for 4 days)        -  Compare the pharmacokinetic profiles of clopidogrel active metabolite between the          selected groups of genotyped subjects and the 2 dose regimen   "
249645|NCT01123837|"     The purpose of this investigator-initiated study is to see if giving dextrose fluid in the     veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic,     gynecologic and breast outpatient surgery patients and at what blood surgery level. The     reason for this study is that IV dextrose has been shown to decrease the incidence of PONV     and the use of medications to treat PONV, while leading to sooner discharge after surgery.     This can decrease overall healthcare cost and improving patient satisfaction.   "
249646|NCT01123850|"     To compare radiographic data collection from patients undergoing instrumented PLF with     CopiOs(R) BVF or instrumented PLF with autologous bone and to assess overall clinical     outcomes. Patients will serve as self controls.   "
249647|NCT01123863|"     A preliminary study was conducted involving 88 three-year-old children with sickle cell     disease (SCD) who were followed at the St. Jude Children's Research Hospital Sickle Cell     Center. They were offered developmental screening with the Brigance Preschool Screen-II test     during their regular clinic visits from January 2006 to August 2008. Data from this work     showed that 50% of 3 year old children with SCD had low developmental screening scores. In     addition, the low scores were found to be associated with less parental education and with     speech deficits. However they were not associated with sickle cell genotype and hemoglobin     level.      The primary goal of this study is to prospectively administer Brigance Preschool Screen -II     to 3 year old children with SCD and 3 year old children without SCD who come from similar     socioeconomic backgrounds and compare the results between the two groups.   "
249648|NCT01123876|"     Assess whether the combination of ABT-888 with FOLFIRI has activity in subjects with gastric     cancer.   "
249649|NCT01123889|"     The purpose of this investigator initiated study is to clinically evaluate the efficacy of a     new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears.     This treatment consists of a platelet rich plasma injection into and around the rotator cuff.     It is thought that this treatment will dramatically improve outcomes for patients suffering     from these two conditions.      Subjects will be randomized by choosing a slip of paper from an envelope. This process will     randomize 25 patients to the experimental group, and 25 patients to the control. The     experimental group will undergo a blood draw, allowing for an injection of platelet rich     plasma around the rotator cuff. The control group will undergo a corticosteroid injection     into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be     followed for three months for pain, and will fill out questionnaires at six weeks and three     months post injection, which will give insight into functionality and pain changes that the     rotator cuff is experiencing due to treatment.      Subjects will be outpatients. Subjects may include employees, students, minorities, and     elderly, although no subsets of these will be formed.      Subjects will be between 18 and 89 years of age.      In total, subject participation will last approximately 3 months.   "
249727|NCT01124019|"     The primary objective is to compare the predicted lifetime risk values produced by SNP panel     assessment to the risk values produced by the prediction models that are most commonly used.     A second objective is to examine whether the incorporation of risk assessment panels     (standard or SNP based) can improve the positive value of breast biopsies in women with     BIRADS 4 mammograms.   "
249650|NCT01123902|"     Breathlessness is a common and distressing symptom in advanced disease. A hand-held fan is a     simple device which has shown, when directed to the patients face, to be effective in     relieving breathlessness.      This phase II trial aims to determine the potential effectiveness of a hand-held fan to     relieve breathlessness over time and to evaluate the recruitment into the study and the     acceptance of the intervention and the control.      The intervention to be tested is a HHF directed to the area of the face innervated by the     second and third trigeminal nerve branches. A wristband was chosen as control under the     assumption that distraction could serve as a placebo.      The main outcomes for this study are uptake into the trial (proportion of patients from the     longitudinal study participating in the RCT), adherence to the study, and use and acceptance     of the intervention and the control. The main outcome for assessing the effect of the     hand-held fan is change of severity of breathlessness between baseline and one month and two     months, respectively.   "
249651|NCT01117428|"     This trial is designed as a multi-centre, open label, dose-escalation, phase I trial and     consists of five parts.   "
249652|NCT01117441|"     Rationale/Purpose: Drugs used in chemotherapy work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Giving more than     one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which     combination chemotherapy regimen is more effective in treating young patients with acute     lymphoblastic leukemia (ALL).      This trial is studying several different combination chemotherapy regimens to compare how     well they work in treating young patients with ALL.      Study objectives      Primary study questions:        -  Non high-risk (non-HR) precursor-B ALL (pB-ALL) patients with TEL/AML1-negative ALL or          unknown TEL/AML1 status and flow cytometry minimal residual disease (MRD) in bone marrow          on day 15 <0.1% or with TEL/AML1-positive ALL (randomized study question R1): Can the          daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior EFS and a          reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)?        -  Patients with pB-ALL and risk group medium risk (MR) (randomized study question R2): Can          the clinical outcome be improved by protracted asparagine depletion achieved through          application of intensified PEG-L-asparaginase during reintensification and early          maintenance?        -  High-risk (HR) patients (as identified by day 33 - randomized study question RHR): Can          the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during          Protocol IB?      Secondary study questions:        -  Standard risk (SR) patients identified by at least one sensitive marker: Is the clinical          outcome comparable to that obtained in SR patients (identified with two sensitive          markers) in AIEOP-BFM ALL 2000, or can the outcome even be improved with the use of          PEG-L-asparaginase instead of native E. coli L-ASP?        -  T-ALL non-HR patients: Can the high level of outcome which was obtained for these          patients in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of          PEG-L-ASP instead of native E. coli L-ASP?        -  HR patients with persisting high MRD levels despite the use of the HR blocks in the          intensified consolidation phase MRD Non-Responders: Is it possible to improve the          outcome and to achieve a further reduction of leukemic cell burden by administration of          an innovative treatment schedule (DNX-FLA)?        -  Patients participating in the randomized asparaginase studies (pB-ALL/MR, HR): Are          asparaginase activity and asparaginase antibodies associated with development of          allergic reactions, and do they have an effect on the outcome of the patients?        -  What is the relative value of different methods of MRD monitoring in the definition of          alternative stratification systems within a BFM-oriented protocol?   "
249654|NCT01117467|"     Simulation is used to teach undergraduate and postgraduate healthcare professionals, however     it is not known how best to use this resource. Using qualitative methods, this study aims to     investigate how medical students learn during simulation scenarios and will compare students     who are paired with peers with those who are solo during their scenarios. Video and audio     data from simulations will be collected and analysed with anxiety and empathy questionnaire     data and semi-structured interviews.   "
249655|NCT01117480|"     The purpose of this study is to evaluate the clinical effectiveness and safety of adalimumab     as used in routine clinical practice in adult participants with moderate to severe rheumatoid     arthritis (RA) in Canada.   "
249656|NCT01117493|"     The aim of this exploratory randomized controlled trial was to investigate the efficacy of a     disease specific Expert Patient Programme compared to usual care in patients with     bronchiectasis. Hypothesis: Disease specific EPP will increase self efficacy compared to     usual care.   "
249657|NCT01117506|"     To validate the use of Corus™ CAD blood assay in subjects who are referred for the work-up of     coronary artery disease. The study will evaluate the clinical utility of a gene expression     test (Corus CAD) in subjects referred for myocardial perfusion imaging (MPI) work-up for     suspected obstructive atherosclerotic coronary artery disease (CAD). The Corus CAD is a gene     expression test that quantify the expression of multiple genes from circulating peripheral     blood cells to detect the presence of clinically significant obstructive CAD in patients with     chest pain.   "
249658|NCT01117519|"     The purpose of this study is to determine whether the administration of a compound of     balanced infusion solutions including 50% crystalloid and 50% colloid has a positive impact     on acid-base balance in elective hip replacement surgery. The application of the study     medication will be carried out through a goal-directed intraoperative therapy by     transoesophageal doppler.   "
249659|NCT01117532|"     Depression is an important mental health concern in college students. This study will recruit     students who test positive for moderate to severe depression on the Beck Depression Inventory     (BDI). Subjects will be randomly assigned to either a treatment or a control condition. Those     in the treatment group will receive four 90 minute group classes using EFT (Emotional Freedom     Techniques) to address traumatic memories and other self-identified causes of depression. It     will compare them to a no treatment control group.   "
249660|NCT01117545|"     EFT (Emotional Freedom Techniques) has been shown to significantly reduce post-traumatic     stress disorder (PTSD) and other psychological symptoms such as anxiety and depression in a     variety of clinical trials. This study examines the effect of a six session EFT protocol on     the symptoms of veterans with clinical scores on the PTSD Checklist-Military (PCL-M).     Subjects in the experimental group receive EFT coaching supplemental to, and supportive of,     the usual care treatment provided by their primary care provider. Subjects in the wait list     control group receive usual care for a month, with pre and posttests, after which they also     receive the EFT coaching protocol. Subjects are followed at three month intervals to     determine if gains are maintained, and whether the symptom reductions are similar to those     observed in other trials of EFT.   "
249685|NCT01117870|"     Pulsed RadioFrequency (PRF) is a relatively new technique derived from a well established and     proven intervention, thermal radiofrequency (RF). Both procedures are used in the treatment     of chronic pain. Unlike RF treatment, PRF does no direct damage to the nerve. During PRF     treatment, electrical energy is applied with a small needle to the affected nerve using a     pulsed time cycle that delivers short bursts of RF current. This study is interested in     looking at the efficacy of PRF for chronic lumbar radicular pain (CLR) and to assess whether     a larger scale clinical study with the same methods can be used.   "
249731|NCT01124071|"     To determine:        1. the acceptability of a Korean diet to an Australian overweight and obese population        2. which Korean recipes are easily prepared        3. the effect of a Korean diet on weight, blood pressure, and metabolic complications of          obesity in this population.   "
249661|NCT01117558|"     PCOS is the most common endocrine disorder in reproductive women. It is estimated that 5 to     10% of women of reproductive age have PCOS. One of the major diagnostic criteria of PCOS was     chronic anovulation which lead to irregular menstruation, amenorrhea, and infertility; the     other diagnostic criteria was hyperandrogenism which lead to hirsutism, acne and alopecia.     Furthermore, PCOS is thought as a metabolic disorder, the long-term consequence of PCOS were     diabetes mellitus and cardiovascular disease, which are potentially dangerous in women     health. Early diagnosis and prevention is very important to the PCOS patients.      Obesity is the most potential risk of threat to health of populations. There is a major     impact of obesity on the PCOS related disorders. Insulin resistance and distribution of     adipose tissue were thought to be the important risk factors of cardiovascular and metabolic     syndrome.      To treat PCOS patients properly,Wan-Fang hospital had established a specific medical team.     The investigators recently published in Fertility and Sterility about the clinical     presentation of androgen excess in Taiwanese women. Hirsutism is much less prevalence in     Taiwanese PCOS women than that previous reported in the Western women. It is important to     know that some clinical presentation of PCOS might have ethic variance. Insulin resistance     was reported as another candidate that might have ethic variance.The investigators had     reported about 40% women in PCOS women were obese, it is similar with previous literature     reported. Obesity is a major factor that could be controlled during the treatment of     PCOS.Weight reduction is one of our methods in PCOS treatment. The progressive results for     obese PCOS women would be facing the risks of diabetes and metabolic syndrome.The     investigators thought like to evaluate the benefit of weight reduction program to the     prognosis of obese women with PCOS. Furthermore, it is known that Endothelial progenitor     cells (EPC) be an early marker of cardiovascular disease, the investigators would like to     know the role of EPC to predict metabolic syndrome in women with PCOS. Wan-Fang hospital has     a professional team in PCOS treatment and research which including gynecological     endocrinologist, cardiologist, medical endocrinologist, specialist in weight reduction. This     team had been working well for more that 4 years.      The investigators hope that they can make a contribution to the study and treatment of PCOS     in Taiwan.   "
249662|NCT01117571|"     The study objective is to evaluate the safety and performance of the ConforMIS iUni®     Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis.     The iUni is a patient-specific unicompartmental resurfacing device designed from the     patient's unique anatomy using proprietary software which interprets data from the patient's     CT scan. The patient matched implant design is then coupled with unique patient-matched     disposable instrumentation designed using the same CT data and software.   "
249663|NCT01117584|"     Evaluate the efficacy, safety and tolerability of a 12-week treatment of 4 doses of ASP1941     compared to placebo in combination with metformin in adult patients with Type 2 Diabetes     Mellitus who have inadequate glycemic control on metformin alone.   "
249664|NCT01117597|"     The purpose of this study is to analyse a possible effect of radiofrequency (RF) fields used     for Terrestrial Trunked Radio (TETRA) of brain activity and cognitive functions in     occupationally exposed subjects.   "
249665|NCT01117610|"     This prospective randomized study aims to evaluate the effectiveness of epidural injection of     ropivacaine on the relief of pain in patients undergoing laminectomy.      Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel     number generation.      Patients in group C will receive no medication intraoperatively, and patients in group I will     receive epidural injection of 0.1% ropivacaine 10ml before skin incision.      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at     4,12,24,48 hour postoperatively.   "
249666|NCT01117623|"     Continuous dosing of BAY73-4506 in patients with advanced cancer   "
249667|NCT01117636|"     The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of     fast release aspirin tablets, 1000 mg (2 x 500 mg) compared to regular aspirin tablets, 1000     mg (2 x 500 mg) and placebo in subjects with postsurgical dental pain.   "
249668|NCT01117649|"     The purpose of this study is to investigate the efficacy of target controlled fluid therapy     with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in     patients undergoing elective surgery of the pancreatic head. A third group receiving a     balanced electrolyte solution (without colloidal volume replacement) will serve as a control     for descriptive analysis.   "
249669|NCT01117662|"     Acute kidney allograft rejection is the major cause for a loss of graft function and has a     negative impact on long-term graft survival. Anti-rejection therapy traditionally focuses on     T cell-mediated mechanisms of renal allograft rejection. However, available agents that     affect T-cell pathways have only little impact on long-term graft survival. There is     increasing evidence that B-cells play an important role in acute transplant rejections. CD20+     B cell infiltrates in acute T-cell mediated rejections are frequent and correlate with a     worse response to conventional anti-rejection treatment and an increased risk of graft loss.     In one pilot study, supported by several case reports, a beneficial effect of Rituximab for     the treatment of acute rejection episodes with intrarenal B-cell infiltrates was shown.     However, despite the promise of these observations solid evidence is required before     incorporating this treatment option into a general treatment recommendation.      In a multicenter randomized placebo controlled double blind phase III trial the investigators     want to demonstrate that Rituximab in addition to standard treatment with steroid-boli is     superior to the standard treatment alone regarding long-term kidney function. If the proposed     study proves that Rituximab treatment of acute rejections is beneficial for the long-term     allograft function, the conventional rejection therapy needs to be revised to this novel     concept of B- cell targeting   "
249670|NCT01117675|"     Background: Antiretroviral therapy has changed the natural history of the HIV infection in     developed countries becoming a chronic disease. This clinical scenario would need a new     approach to control patients, simplifying the follow-up visits and the accessibility to the     healthcare professionals. A new home care model using a telemedicine system (Virtual     Hospital) was developed.   "
249671|NCT01117688|"     The purpose of this study is to investigate the impact of a safety guidewire (SGW) on the     results of ureteroscopy for urolithiasis.      Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment     of urolithiasis.   "
249672|NCT01117701|"     The purpose of this study is to investigate to forces needed to passage the ureteroscope up     and down the ureter with and without a safety guidewire in place.   "
249686|NCT01117883|"     This protocol is a prospective interventional pilot study at the Children's Hospital of     Philadelphia to determine whether or not two increments of sternal pressure known to occur     during leaning in CPR affects hemodynamic function, coronary perfusion pressures, and     intrathoracic pressure in order to inform the resuscitation community on reasonable target     pressures to avoid leaning on the chest during pediatric CPR.   "
249728|NCT01124032|"     The study assesses the effect of Ritalin on working memory,attention,and decision-making     measures in adults with ADHD and compares it to its effect on healthy adults, in a     double-blind crossover design.We hypothesize that Ritalin will result in better performance     in all measures,and that the improvement will be greater in the ADHD group.   "
249673|NCT01117714|"     About half of all lung cancers are caught after they have spread to nearby lymph nodes. Lymph     nodes are small glands found throughout the body that remove bacteria and foreign particles     (part of the immune system). A biopsy (tissue sample) can then be sent can be sent to the     laboratory for testing. Biopsy results can determine if the cancer has spread (metastases)     and to determine the best treatment for a patient with lung cancer.      The purpose of this study is to develop a better way to detect lung cancer earlier before it     spreads. This study compares the traditional mediastinoscopy/thoracoscopy surgery with the     newer combined Endobronchial Ultrasound (EBUS) and Endoscopic Ultrasound (EUS) -guided fine     needle aspiration (FNA) to see if either is better for this purpose. Traditional medical     practice is to surgically open the chest and biopsy suspicious lymph nodes (called a     mediastinoscopy/thoracoscopy). Some medical centers have already started combining the use of     EUS plus EBUS as a standard practice for performing needle biopsy of lymph nodes in the chest     to stage and treat lung cancer.      Volunteers for this study have been diagnosed with known or suspected lung cancer, and will     receive one of two choices to determine if their cancer has spread:        1. Traditional Surgical Mediastinoscopy/Thoracoscopy Mediastinoscopy is a surgical          procedure that allows physicians to view areas of the chest(including the heart,          vessels, lymph nodes, trachea, esophagus, and thymus). An endotracheal (within the          trachea) tube is inserted followed by a small incision (cut) in the chest. A          mediastinoscope is inserted through the incision to see the organs inside the          mediastinum and to collect tissue samples. Mediastinoscopy can be used to detect or          stage cancer.           Thoracoscopy is a surgical procedure that involves insertion of a thorascope through a          very small incision in the chest wall. A thorascope is a thin, tube-like instrument with          a light and lens which usually has a tool for removing tissue. This makes it possible to          examine the lungs or other structures in the chest cavity, without making a large          incision.        2. EBUS combined with EUS-guided FNA EUS involves the use of a special endoscope fitted          with an ultrasound processor at its tip. During EUS, images of surrounding lymph nodes          can be obtained and a small needle can be guided through the esophagus into suspicious          nodes to biopsy lymph nodes in the chest. Other research studies have shown that using          EUS to guide needle biopsy of lymph nodes in the chest is equally if not more accurate          than surgical biopsy. However, use of EUS for needle biopsy can limit what is seen by          the physician and also limit the sampling of lymph nodes in front of the trachea. EBUS          involves the use of a small ultrasound scope that is passed through the opening of the          trachea and into the airways. EBUS combined with EUS is a less invasive procedure that          provides full view of the lymph nodes in the chest area.   "
249674|NCT01117727|"     The purpose of this research is to develop tools to help people who are paralyzed. These     tools are called brain-computer interfaces (BCIs). BCIs would allow a person to use brain     signals to operate technology. Specifically this project's goal is to design a BCI to operate     a switch.   "
249675|NCT01117740|"     The goal of this clinical research study is to compare 2 different methods for treating a     pleural effusion. Researchers also want to learn how the treatment you receive effects your     quality of life (your ability to do the things you like to do and how happy you feel.   "
249676|NCT01117753|"     Adolescent substance abuse results in significant negative outcomes and extraordinary costs     for youths, their families, communities, and society. Moreover, rates of psychiatric     comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual     diagnosis are more than twice as costly to treat compared to those with no comorbidity. The     applicant principal investigator recently completed a pilot project funded by the National     Institute on Drug Abuse focused on developing and piloting a psychosocial treatment     specifically for youth presenting for outpatient treatment with co-occurring substance use     and internalizing (i.e., mood and/or anxiety) problems. Results were promising with the     experimental group exhibiting significantly less substance use and more rapid reductions in     anxiety and depressive symptoms compared to the control group. The proposed research is a     randomized clinical trial (RCT) to compare the experimental treatment (OutPatient Treatment     for Adolescents; OPT-A) to an active placebo on key clinical indices from pre-treatment     through 18 months. The proposed RCT (n = 160) employs the treatment manual, quality assurance     protocol, and therapist training protocol developed and successfully tested in the pilot     study, to evaluate the efficacy of OPT-A for youth referred to outpatient treatment of     co-occurring substance use and internalizing problems. The following outcomes will be     evaluated: drug use; mental health; behavioral, school, peer, and family functioning; and     consumer satisfaction. The intervention addresses one of the more prevalent and most     challenging, costly, and understudied presenting problems among adolescent outpatients. If     successful, this research could provide a considerable contribution in the treatment field     for youth with co-occurring substance use and internalizing disorders.   "
249677|NCT01117766|"     Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to     detect treatment efficacy in small-scale clinical trials. Combining conventional pain     efficacy measures with quantitative sensory testing (QST) may provide more sensitive and     informative outcome measures in clinical trials.   "
249678|NCT01117779|"     TRACE is an observational, open-label, single-arm, multi-center registry of subjects who have     undergone renal lesion cryoablation per their physician's standard of care. Patients 18 years     of age or older who have been determined to be an appropriate candidate for cryoablation will     be offered enrollment into the registry. Subjects will be observed for five years from the     date of their cryoablation procedure.   "
249679|NCT01117792|"     The primary objective is to evaluate the S-ICD system's ability to identify and terminate     induced ventricular fibrillation in patients during the implant procedure. The safety and     performance of the S-ICD system will also be assessed throughout the patient follow-up     period.   "
249680|NCT01117805|"     The proposed randomized controlled trial will evaluate an innovative intervention in 420     African American women with asthma. It will be the first to use a highly tailored, telephone     counseling approach to address both specific cultural factors affecting asthma and the     influence of female sex and gender on control.   "
249681|NCT01117818|"     This is a multiple vaccination study to find out if it is a safe treatment and what effects     it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80     years. Approximately 40 study sites in Europe will be involved. Patients will be randomized     to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.   "
249682|NCT01117831|"     Project: An analysis of Diabetes Control in Puerto Rico Hypothesis: This project seeks to     determine the causes for: i) poor adherence to prescribed treatment by patients, ii) low     compliance by providers with national guidelines iii) barriers impose by health insurance in     control of diabetes mellitus iv) effectiveness of a disease management program for treatment     adherence by patients.   "
249683|NCT01117844|"     This is a Feasibility/Phase II study for patients with a diagnosis of WHO Grade I - III     Meningioma & Hemangiopericytoma brain cancer to be given standard dose Proton radiotherapy.     The study will be performed in two phases: first, feasibility with an enrollment of 12     patients and then Phase Page 8 of 20 II, with an enrollment of an additional 38 patients. All     patients will also be given quality of life (QOL) instruments pretreatment, weekly during     treatment, then q 3 months for year 1 post treatment, q6 months year 2 & 3 and yearly for     year 4 & 5. Comparisons will be made between the enrolled subjects receiving proton therapy     and the known literature on photon radiation. See section 2 for full objectives. The second     phase will begin no earlier than 60 days after the last patient in the initial phase has     completed treatment and once safety and feasibility has been verified. The secondary     objectives will serve as the objectives for the second phase of the study.   "
249729|NCT01124045|"     The primary objective of this study was to compare the safety and efficacy of Durezol™     compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a     pediatric population 0 to 3 years of age.   "
249787|NCT01127529|"     The overall objective is to collect and assess data on the treatment, safety, and treatment     outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment     registry.   "
249687|NCT01117896|"     This prospective, randomized experimental trial to determine whether the quality of     healthcare provider/rescuer chest compressions (CC) deteriorates at the same rate in     pediatric models as compared to adult models. To determine the relationship between     physiologic/metabolic markers of work in rescuers and chest compression deterioration, and to     determine the effect of stepstool use on the quality of chest compressions and metabolic     demand. To determine whether the quality of chest compressions deteriorates at the same rate     in participants using a stepstool compared to those not using a stepstool.   "
249688|NCT01117909|"     The goal is to determine if standard therapy including joint mobilizations of the ankle     performed 3 times per week for 2 weeks will increase self-reported function and decrease pain     in patients with mild lateral ankle sprains.   "
249689|NCT01117922|"     This is a randomized clinical trial in which all Philadelphia resident women experiencing a     pre-term birth (PTB) at <34 weeks of gestation (GA) over an 18 month period will be     approached at the time of the postpartum hospital stay. Consenting women will be randomized     into a usual care group or an interconceptional intervention targeting five risk conditions,     all of which increase systemic inflammation. Our primary objective in this study is to assess     the efficacy of our interconceptional intervention on the rate of repeat PTB.   "
249690|NCT01117935|"     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill     tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy,     that delivers a high dose of radiation directly to the tumor may kill more tumor cells and     cause less damage to normal tissue.      PURPOSE: This clinical trial studies intensity-modulated external beam radiation therapy in     treating patients with prostate cancer.   "
249691|NCT01117948|"     Study title: A multicentre double-blind, placebo-controlled, randomised, parallel-group study     to evaluate the safety and efficacy of Lornoxicam in patients with mild to moderate probable     Alzheimer's Disease.      Study phase: II      Indication: Alzheimer´s Disease      Investigational product, dose schedule and route of administration: Lornoxicam (8 mg) tablets     to be taken orally two times daily (BID) for a period of 6 months.      Reference product, dose, schedule and route of administration: Placebo (8 mg) tablets to be     taken orally two times daily (BID) for a period of 6 months.   "
249692|NCT01117961|"     Study goal is to determine whether behavioral lifestyle intervention during pregnancy can     reduce the number of women who exceed the Institute of Medicine recommendations for weight     gain during pregnancy.      It is hypothesized that the intervention will reduce the number of women who exceed weight     gain guidelines relative to standard care. The investigators also expect the intervention to     reduce the proportion of women exceeding weight gain guidelines in both normal weight and     overweight groups.   "
249693|NCT01117974|"     Liposuction, one of the most common cosmetic procedures performed in the United States, is a     surgical technique used to reduce localized areas of excess subcutaneous fat. The neck is a     common area of treatment, where liposuction reduces fat volume and neck size. We hypothesize     that suctioned removal of fat of the neck will reduce the severity of obstructive sleep     apnea.   "
249694|NCT01117987|"     This is a multinational, multi center extension study. This study will provide data on the     long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary     arterial hypertension.   "
249695|NCT01118000|"     Numerous studies Have shown that limb ischemic preconditioning can protect vital organs     (including the heart) from ischemia-reperfusion injury,which has a broad application     prospect.But its mechanism is still unclear. Evidence showed that humoral mechanisms may play     an important role. This study was carried out on the limb ischemic preconditioning in healthy     volunteers, collected their serum at different time points before and after     treatment,classified and identified the serum proteins during different periods of limb     ischemic preconditioning,by using methods including high abundant protein     removal,Two-dimensional electrophoresis chromatography and mass spectrometry,then analysed     activation and synthesis of the proteins in order to search for the proteins or peptides     whose synthesis was activated by ischemic preconditioning. This study will be the first     systemic explore of the changes in serum proteins of limb ischemic preconditioning in human     body,and lay theoretical basis for the clinical application of limb ischemic preconditioning     and for further explore of its humoral mechanism,thus provide clues for searching for protein     or peptide having protective effects for organs.   "
249696|NCT01118013|"     RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a     peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop     the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted     cells from a donor can make an immune response against the body's normal cells. Giving     methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop     this from happening. Once the donated stem cells begin working, the patient's immune system     may see the remaining cancer cells as not belonging in the patient's body and destroy them     (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells     (donor lymphocyte infusion) may boost this effect.      PURPOSE: This phase II trial is studying how well donor stem cell transplant works in     treating patients with relapsed hematologic malignancies or secondary myelodysplasia     previously treated with high-dose chemotherapy and autologous stem cell transplant .   "
249706|NCT01118143|"     The purpose of this study to investigate attitude, oral health literacy and psychological     factors in order to evaluate if these factors are important for oral health in adults.      The hypotheses are:        -  Multiple interactive demographic, and social and psychological factors contribute to the          level of attitude and oral health literacy.        -  There is an association between the level of oral health literacy and oral health status        -  A structured intervention based on oral health literacy can change the attitude and          improve the oral health status.        -  Background knowledge has influence on attitude and oral health literacy        -  Individuals with positive attitude towards dental health and dentist are attentive          towards their oral health.   "
249707|NCT01118156|"     The purpose of this study is to evaluate whether a new standardized language for categorizing     suicidal and self-injury related thoughts and behaviors can be readily adopted for use by     mental health clinicians. Efforts also include developing a measure that can be used to help     clinicians identify appropriate terms (e.g., behaviors) for specific patients.   "
249697|NCT01118026|"     This research is being done in order to improve treatment outcomes in patients diagnosed with     bulky, early stage Hodgkin lymphoma and to reduce the side effects that are associated with     use of radiation used in current treatments. The chemotherapy treatment in this study     consists of a combination of four drugs approved by the Food and Drug Administration (FDA):     doxorubicin, bleomycin, vinblastine, and dacarbazine. This regimen (called ABVD) has been     found to be effective in treating patients with Hodgkin lymphoma and is considered the     standard of treatment used with radiation therapy in patients with bulky early stage Hodgkin     lymphoma. As part of the evaluation of the effectiveness of the chemotherapy treatment, PET     scans will be obtained during the course of therapy. The usefulness of this PET scan will be     evaluated to determine whether radiation may be left out in the treatment of disease if the     PET scan shows that the patient has responded to chemotherapy alone. The plan is to identify     a group of patients using early PET scans in order to change to a chemotherapy treatment     called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine,     procarbazine and prednisone). It is one of the most highly effective chemotherapy regimens     for Hodgkin lymphoma, but is associated with more side effects than ABVD. Although it has     become standard of care in Europe, its use has been more limited in the U.S. because of     concerns about toxicity.   "
249698|NCT01118039|"     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying the side effects of giving sunitinib malate and to     see how well it works in treating patients with locally recurrent, locally advanced,     unresectable, or metastatic urinary tract cancer.   "
249699|NCT01118052|"     This phase II trial studies the side effects and how well EGEN-001 works in treating patients     with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that is     persistent or has come back. Biological therapies, such as EGEN-001, use substances made from     living organisms that may stimulate or suppress the immune system in different ways and stop     tumor cells from growing.   "
249700|NCT01118065|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with     progressive or recurrent, unresectable, or metastatic thyroid cancer.   "
249701|NCT01118078|"     This research study is studying biomarkers in tissue samples from patients with high-risk     Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help     doctors to learn more about changes that occur in DNA and identify biomarkers related to     cancer.   "
249702|NCT01118091|"     Background:      - Adoptive cell therapy involves taking white blood cells called lymphocytes from patients'     tumors, growing them in the laboratory in large numbers, and then giving the cells back to     the patient to allow the cells to attack the tumor. Because this process is lengthy and     difficult to perform, researchers have been developing improved means of performing adoptive     cell therapy. Researchers are now interested in comparing adoptive cell therapy with the     standard treatment for metastatic melanoma (skin cancer).      Objectives:      - To compare the effectiveness of adoptive cell therapy with standard high-dose aldesleukin     as a treatment for metastatic melanoma.      Eligibility:        -  Individuals 18 years of age or older who have been diagnosed with metastatic melanoma          and have not previously received aldesleukin therapy or cell therapy for their disease.        -  Participants must have at least one tumor that can be easily removed as part of the          treatment procedure.      Design:        -  Participants will be screened with a full medical history, physical examination, blood          and urine tests, and imaging scans to evaluate tumor size and treatment options.        -  Participants will be separated into two groups, in which one group will have adoptive          cell therapy and one will have aldesleukin treatment.        -  Adoptive Cell Therapy             -  Participants will have a tumor sample taken in order to collect white blood cells               for treatment. Participants whose tumors do not provide sufficient white blood               cells may be switched to the aldesleukin-only treatment group.             -  The white blood cells will be grown in the laboratory for several weeks.             -  Prior to receiving cell therapy, participants will receive chemotherapy for 7 days               to improve the chances of successful treatment.             -  Participants will have cell therapy followed by high-dose aldesleukin treatment               every 8 hours for up to 5 days. This treatment will be followed by 1 to 2 weeks of               recovery time as an inpatient at the clinical center.             -  Participants will be evaluated at 12 weeks following the start of the study, every               2 to 3 months for the first year, every 6 months for the next 5years, and then               yearly thereafter..        -  Standard Aldesleukin Treatment             -  Participants will have high-dose aldesleukin treatment every 8 hours for up to 5               days (one cycle of treatment), and will have a second cycle of treatment 7 to 10               days after the first cycle.             -  If tests show that the tumors have grown, participants will be offered the chance               to have additional cycles of aldesleukin, or begin a cell therapy treatment.        -  Participants will be evaluated at 12 weeks following the start of the study, every 2 to          3 months for the first year, every 6 months for the next 5years, and then yearly          thereafter.   "
249703|NCT01118104|"     People with chronic respiratory disease have shortened work life, their disease is associated     with greater work disability and they are at greater risk of being unemployed. Lower     employment rates and higher sickness absence is expensive for the community and leads to     financial as well as social consequences for the individual.      There is a lack of data on factors that can predict sickness absence and disability in     patients with pulmonary disease. We therefore want to study a group of people with COPD and     asthma referred to our clinic. The study will investigate relationships between sickness     absence and exercise capacity, job-related factors, disease severity, self-efficacy, health     related quality of life and subjective health complaints.   "
249704|NCT01118117|"     OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects     will undergo a superficial femoral artery (SFA) stent procedure using the Misago™ Peripheral     Self Expanding stent once all of the inclusion and none of the exclusion criteria are met.     The stent efficacy and safety will be evaluated immediately post procedure, and at 30 days,     6, 12, 24, and 36 months post procedure. A subject is considered enrolled into the OSPREY     study after he/she signs the informed consent and meets all inclusion/exclusion criteria.      The study objectives are to demonstrate that efficacy and safety of this novel stent design     are not inferior to historical Percutaneous Transluminal Angioplasty (PTA) and stent outcomes     and meet the performance goals as published in the objective performance goals by     Rocha-Singh, et al. This is a multi-center, single arm, non-randomized, prospective clinical     trial of the Misago™ Self-Expanding Stent System for the treatment of atherosclerotic     stenosis and occlusions of the SFA. The primary endpoint of stent patency will be evaluated     at 12 months.   "
249705|NCT01118130|"     To investigate whether genotypic differences can be identified between MS patients developing     'liver injury' (defined as ALT levels five times the upper normal limit and above) compared     to those not developing liver injury after exposure to beta-interferon for MS.   "
249708|NCT01118169|"     The primary aim of this study is to examine the relationship between personal values and     suicidal thoughts in a sample of U.S. Veterans.   "
249730|NCT01124058|"     A prospective, randomized trial to compare the time taken to achieve a therapeutic INR upon     re-starting warfarin at a loading dose (namely 1.5 times the maintenance dose for 3 days)     compared to the known maintenance dose.   "
249816|NCT01127906|"     PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin     that has been sensitized to heat by ultraviolet light. This study is designed to see if this     is also true in man.   "
249709|NCT01118182|"     The primary aims of this study are to: 1) Establish the concurrent criterion-related validity     of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State     University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent     criterion-related validity of the TBI-4 with the addition of detailed information elicited by     the four questions. Secondary aims include: 1) Determining if the addition of detailed     information elicited by the TBI-4 results in increased specificity; 2) Determining whether     the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous     research; and 3) Determining whether psychiatric outcomes are worse for veterans with     traumatic brain injury (TBI) than those with no traumatic brain injury(TBI).      Primary Hypotheses:      Hypothesis 1a: The sensitivity and specificity of the TBI-4 will be significantly greater     than 0.75 and 0.80, respectively.      Hypothesis 1b: The sensitivity and specificity of the TBI-4 with the addition of detailed     information elicited by these questions (i.e., free text information entered by the clinician     who administered the TBI-4) will be significantly greater than 0.75 and 0.80, respectively.      Secondary Hypotheses:      Hypothesis 1c: The specificity of the TBI-4 with the addition of detailed information     elicited by these questions (i.e., free text information entered by the clinician who     administered the TBI-4) will be significantly greater than that of the four questions alone.      Hypothesis 2: A significant difference in psychiatric outcomes (psychiatric hospitalizations,     suicidal ideation, suicide attempts and completions, and mental health-related contacts) will     be identified in those with a history of TBI versus those without a history of TBI as     determined, first, by the TBI-4 and, second, by the OSU TBI-ID.      Hypothesis 3: The prevalence of Traumatic Brain Injury- Loss of Consciousness (TBI-LOC) in     this population will be similar to that identified by Walker et al1 (31.7% of individuals     will report 1 or more TBI-LOC).   "
249710|NCT01118195|"     This is a study to learn more about traumatic brain injury (TBI) and suicidal behaviors. The     purpose of this research is to find out more about the issues related to these conditions.     This study seeks to explore the relationship between executive dysfunction and suicidal     behavior in an outpatient population.   "
249711|NCT01118208|"     This quantitative, interview-based study will determine if increased prescription medication     adherence via blister pack administration will reduce suicide related behavior among the high     risk population of patients discharged from a psychiatric inpatient unit. The aims of the     project are to determine whether blister packaging medication significantly increases     treatment adherence and if blister packaging significantly decreases intentional     self-poisoning behavior (i.e., suicide attempts and completions). By tracking former     psychiatric inpatients for 12 months post-discharge and obtaining monthly medication     adherence ratings, we will determine if blister packaging (BP) medications leads to better     adherence than dispensing as usual (DUA). The psychiatric patients we will be recruiting have     been diagnosed with, major affective disorder, bipolar affective disorder, post-traumatic     stress disorder, or schizophrenia (or any combination of these diagnoses). By tracking former     psychiatric patients for 12 months post-discharge and obtaining monthly reports (self-report     and medical record review) of suicide-related behaviors, we will determine if patients in the     BP condition have less intentional self-poisoning behavior than those in the DAU condition.   "
249712|NCT01118221|"     The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more     often in older males. Cigarette smoking and environmental dust exposures are known risk     factors for developing IPF. For example, the recently deployed military population, as it     ages, is at especially increased risk of IPF. No effective therapies exist, although lung     transplantation is used to extend survival of selected patients.      Defining specific therapy to improve exercise tolerance and dyspnea in IPF patients is thus     an urgent priority of veteran-oriented research programs.   "
249713|NCT01118234|"     The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to     prolong progression free survival in patients with chronic lymphocytic leukemia, who     responded to a Rituximab induction therapy.   "
249714|NCT01118247|"     Both HA coated and certain uncoated femoral stems have good results in general. On the cup     side the results are more variable, either with or without HA. HA may delaminate from the     prosthesis, damage the articulation, witch may lead to osteolysis and aseptic loosening.      The investigators are investigating whether a well working uncemented hip prosthesis design     with HA coating, will perform without HA in the long run, when the investigators use pure Ti     macrostructure and alumina on alumina articulation.      Hypothesis: The bone ingrowth will be equal when the surface has almost equal roughness in Ti     and HA version. This means that HA on Ti is not necessary with a well functioning prosthesis     design.      0-hypothesis:The two prosthesis perform equal in survival, clinically (HHS),radiographic and     in patient satisfaction at 2, 5, 10, 15 and 20 years.   "
249715|NCT01118260|"     Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing     transurethral prostate resection   "
249716|NCT01118273|"     The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen     sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and     an ibuprofen and diphenhydramine combination   "
249717|NCT01118286|"     To investigate the therapeutic effectiveness of long acting nifedipine containing combination     therapy in the treatment of hypertensive patients.   "
249718|NCT01118312|"     The trial will study the effectiveness of nasal steroids for the treatment of chronic     rhinitis and/or sinusitis on asthma control.   "
249719|NCT01123915|"     This phase I study is the first step to determine if Opal immunotherapy may have potential     utility as a treatment for HIV. Although effective treatments for HIV infection exist, they     are limited by the requirement for life-long daily treatment, cost, side effects, and the     development of resistance.      There is a need for therapeutic approaches that induce or enhance T-cell immunity to control     HIV disease. Overlapping Peptide-pulsed Autologous Cells (Opal) is a technique where     autologous peripheral blood mononuclear cells (PBMC) or whole blood is pulsed with sets of     overlapping peptides spanning whole proteins of HIV.   "
249720|NCT01123928|"     The purpose of this study is:        1. To determine whether an educational intervention designed based on studies in the area          is effective in increasing acceptance of surgery and presentation to the hospital, when          adjusting for a number of potential determinants of service uptake;        2. To assess short-term impact of the educational intervention on knowledge about cataract          and attitudes toward locally-available surgical services.   "
249721|NCT01123941|"     This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197     conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently     licensed Vi polysaccharide vaccine.   "
249722|NCT01123954|"     The present study will evaluate the safety in healthy people aged 1- 45 years (male and     female) after single intramuscular (IM) dose of trivalent subunit inactivated influenza     vaccine till the 30-days follow-up period.   "
249723|NCT01123967|"     This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy     (NRT) to increase the population impact of tobacco cessation treatment for diverse, low     income smokers. Population impact is the product of treatment utilization (i.e., reach or     exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize     treatment).   "
249753|NCT01127074|"     In the last few years there has been a great attempt to develop active immunotherapies for     breast cancer patients (BCPs) using undefined as well as selected antigens to activate tumor     specific T-lymphocytes. The purpose of this phase-I study was to determine the safety and     feasibility of vaccinations with an allogeneic breast cancer cell line, KS24.22, genetically     modified to express CD80 and Her-2/neu, and to evaluate the efficacy of inducing tumor     antigen-specific immune responses in human leukocyte antigen(HLA)-A*02-matched patients with     metastatic breast cancer.   "
249754|NCT01127087|"     Hypothesis: Oral administration of the oxalate metabolizing enzyme Oxazyme (OC4) will degrade     food-borne oxalate and hence prevent its absorption from the gastrointestinal tract. In     addition, by reducing oxalate concentrations in the gastrointestinal fluid, oxalate secretion     from blood to the intestinal tract may be increased. Both effects would decrease blood levels     of oxalate, and hence oxalate excretion in the urine.   "
249732|NCT01124084|"     Application of health information technology be able to solve a lot of problems of medical     management, and effective actions to achieve the purpose of medical care. The Personal     Health Record (PHR), so that patients can have, access and update their health records and     share health information to a new healthcare provider can avoid the duplication of a clinic     procedures, reduce medical costs and time, and can make an appointment online, tracking     vaccinations, check drug allergy, master with health-related information such as exercise,     diet condition, and have no time constraints to the hospital clinic. In the future, PHR is     expected to reduce medical errors, reduce costs, effective use of medical resources. Purpose     of this study is to understand the impact to the staff's attitude and intention when they use     the PHR, and to explore the medical records of personal health awareness and intention to use     the relevant factors, the research result will be a reference to government authority or     medical institutions in order to promote personal health record system in Taiwan.      In this study, there will include the medical staff of three hospitals in Taipei, the     Technology Acceptance Model (TAM model) based structured questionnaire will be used,     questionnaire had tested by validity and reliability. The electronic questionnaires will be     used, and apply the software SPSS and Amos17.0 descriptive and inferential statistical     analysis.   "
249733|NCT01124097|"     The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate     (ESL) as therapy in subjects with Post-herpetic Neuralgia (PHN) over a 15 week treatment     phase.   "
249734|NCT01124110|"     This is a clustered randomized control trial to test the Tobacco Tactics intervention among     Operating Engineers (heavy equipment workers). The intervention group will be directed to the     Tobacco Tactics website, and the control group will be directed to the state supported 1-800     quit-now telephone hotline during routine annual safety training that all Operating Engineers     are required to attend. The web-based quitting intervention includes provision of     over-the-counter nicotine replacement therapy and will be followed by nurse email and/or     telephone counseling. It is expected that Operating Engineers who are randomized to the     Tobacco Tactics website intervention will have at least equal or greater decreases in smoking     at 30-day and 6-month follow-up compared to those randomized to the 1-800-QUIT-NOW quit line.     In addition, the investigators expect to find that Operating Engineers randomized to the     Tobacco Tactics website intervention will: a) be able to accomplish tasks; b) be able to     accomplish goals with skill and speed; c) be able to operate the system; d) be satisfied with     the website; e) access the site repeatedly; and f) spend time on the site during the     intervention period.   "
249735|NCT01124123|"     The purpose of this study is to assess the absolute bioavailability of an oral bilastine     formulation (test drug) compared to the endovenous administration of an IV bilastine     formulation (control drug) in healthy volunteers.   "
249736|NCT01124136|"     The purpose of this study is to study the use of neurostimulation in chronic advanced     refractory heart failure.      The study is determine if it is safe to use neurostimulation in patients with chronic     advanced refractory heart failure and to also determine initial observations with regards to     its potential effect on heart function and quality of life. The investigators hypothesis is     that this study will show both safe and positive effect of neurostimulation on heart failure     patients.   "
249737|NCT01124149|"     This study was designed to evaluate if subjects who achieve complete remission after 8 weeks     of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term     outcomes and remain in remission longer compared with subjects who demonstrate only partial     remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore,     subjects who achieve either complete or partial remission will enter into a 12-month     maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given     QD. Remission status for the 2 groups will be evaluated and compared at the end of this     12-month maintenance period. The data obtained from this study will provide scientifically     meaningful information to demonstrate that achieving complete remission (clinical and     endoscopic remission) is important for a better long-term prognosis, or that the current     paradigm of symptomatic treatment is appropriate.   "
249738|NCT01124162|"     The objective of this study is to compare the rate and extent of absorption of losartan 100     mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fasting     conditions.   "
249739|NCT01124175|"     The objective of this study is to compare the rate and extent of absorption of losartan 100     mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fed     conditions.   "
249740|NCT01124188|"     The primary question addressed by this study is: Using a stepped care approach in primary     care, what is the value of the combination of an antidepressant medication (Venlafaxine) and     psychotherapy for seniors living with depression and chronic lower back pain when treatment     with a low-dose of venlafaxine and supportive management (SM) has led to only a partial or     non-response?   "
249741|NCT01124201|"     The purpose of this study was to compare the efficacy of three exercise programs in patients     with chronic low back pain: Segmental stabilization, superficial strengthening and     stretching. Groups were contrasted regarding pain, functional disability and TrA muscle     activation capacity. The three groups of exercise improved pain and functional disabilities,     and the Segmental stabilization group was better in the ability to recruit TrA muscle.   "
249836|NCT01128166|"     The goal of the MultiSENSE study is to collect chronic information from multiple sensors in     an implanted device for evaluation in heart failure patients.   "
249742|NCT01124214|"     Endomicroscopy (EM) can improve the diagnosis Barrett's esophagus (BE) and some early     esophageal cancers (Intra Epithelial Neoplasia (IEN)). EM provides optical biopsies     comparable to standard histology. Specifically, EM allows targeted biopsy rather than random     mucosal biopsy during routine endoscopic surveillance of BE or evaluation EIN, which will     improve the diagnostic yield of mucosal samples for BE IEN. Furthermore, when combined with     high resolution endoscopy, EM may improve the overall in vivo detection of IEN in lesions as     well as flat mucosa.      EM will provide accurate place and size of IEN which will impact the physician's decision to     biopsy or perform endoscopic mucosal resection (EMR). This could potentially minimize the     number of unnecessary biopsies and as well as enable the physician to perform EMR at the time     of the initial examination, rather than delaying endoscopic treatment after the pathology is     available. This study is important because it will validate single center studies supporting     the routine use of EM for screening and surveillance of BE.   "
249743|NCT01124227|"     Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor     prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis     (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA     stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this     condition and to find an optimal scheme.      Objective: To improve symptomatology in severe chronic failure patients. Study design: Open,     parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin     (Extraneal®) with standard medical therapy..      Study population: Patients with chronic refractory left ventricular congestive heart failure     (LVEF < 30%, older than 18 years).      Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with     icodextrin (Extraneal®).      Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive     Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure:     measured by reduction in unfavorable days (noted by patients in diaries and including days of     hospitalization for CHF-deterioration and death).   "
249744|NCT01124240|"     Cilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months without     interruption.      Starting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with     concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA     < 1.7; 100 mg p.o. if BSA ≥ 1.7) is given over a period of 6 weeks (RTX Monday to Friday,     both TMZ and PCB seven days a week).      After a break of 4 weeks, adjuvant TMZ (50mg/m2 p.o in first cycle, 60 mg/m2 p.o. in     subsequent cycles) and PCB (50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) are then given     daily D1 to 20. This TMZ/PCB cycle is repeated every 28 days over a total period of 6 cycles.   "
249745|NCT01126970|"     To evaluate the weight loss effect and safety of 400 mg velneperit and 120 mg orlistat     administered individually or combined three times per day for 24 weeks while on a reduced     calorie diet (RCD) and also to evaluate the steady-state trough concentrations of velneperit     (S-2367), velneperit (S-2367) tert-butyl OH, and velneperit (S-2367) tert-butyl OH-O     glucuronide following 400 mg of velneperit (S-2367) three times per day and 120 mg of     orlistat, either combined or separate.   "
249746|NCT01126983|"     To assess lead migration rates using different methods of securing leads during Spinal Cord     Stimulation trial period.      Spinal cord stimulation has two phases. Trial, which is a precursor for a permanent     implantation. Trial lasts less than a week, which gives the patient an opportunity to assess     the effectiveness of the treatment.   "
249747|NCT01126996|"     Neisseria meningitidis occurs worldwide as endemic disease1 and is a major cause of invasive     infections such as meningitis and septicaemia. Three protein-polysaccharide conjugate     serogroup C meningococcal (MenC) vaccines were developed in the late 1990's and an     accelerated programme of clinical trials in the UK led to licensure of these MenC vaccines in     1999 and these vaccines were introduced into the routine infant immunisation schedule at 2, 3     and 4 months. However, children who were aged 1-18 years in 2000 only received a single dose     of a MenC conjugate vaccine during the mass immunisation campaign.      Previous studies have demonstrated rapid waning of MenC specific antibody concentrations and     serum bactericidal antibody (SBA) titres following immunisation in young children. A     cross-sectional review on rates of sero-protection against MenC disease in the UK has     demonstrated that the majority of children who were immunised with a single dose of a MenC     conjugate vaccine between the ages of 1-10 did not have protective titres of MenC SBA 7 years     after the immunisation campaign. As this cohort of children reaches adolescence there is a     risk of increased transmission of the organism and a resurgence of meningococcal disease in     children who do not have protective levels of antibody. There is thus a need to conduct a     study evaluating the changes in MenC SBA titres over time in children who received a single     dose of a MenC vaccine in early childhood which is the main objective of this study.   "
249748|NCT01127009|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone, etoposide, and     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving bortezomib together with combination     chemotherapy may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     given together with mitoxantrone, etoposide, and cytarabine in treating patients with     relapsed or refractory acute myeloid leukemia.   "
249749|NCT01127022|"     The purpose of this study is to investigate the effect of varied maternal choline intake on     maternal/fetal biomarkers of choline status, genomic expression and metabolomic profiling.   "
249750|NCT01127035|"     Respiratory allergy due to Alternaria is a relevant clinical problem, and specific     immunotherapy may represent a viable treatment option. Sublingual immunotherapy (SLIT) is     safe and effective, but data for Alternaria are lacking. The study is aimed at assessing the     efficacy of a standardized SLIT in patients sensitised to Alternaria, in a randomized, double     blind, placebo controlled fashion.      Patients with rhinitis with/without intermittent asthma, and ascertained allergy to     Alternaria are enrolled. After a baseline season, SLIT or matched placebo are given for 10     months. Symptoms and rescue medication intake are recorded on diary cards from June to     October. Skin prick test, specific IgE and IgG4 and precipitins are measured at baseline and     at the end of the study. Alternaria spore count is also performed. Primary outcome is the     change in symptom score in the active vs placebo group. Secondary outcomes: changes in rescue     medication intake, alternaria specific IgE and IgG4, skin prick test reactivity.   "
249751|NCT01127048|"     The aims of this study are        -  Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in          children suffering from acute bronchitis accompanied by coughing        -  Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison          with placebo.   "
249752|NCT01127061|"     The investigators propose a pilot randomized controlled trial to determine the safety and     potential benefits of moderate intensity exercise in patients with hypertrophic     cardiomyopathy. The investigators hypotheses are that exercise parameters derived from a     baseline cardiopulmonary exercise test will target an appropriately safe level of exercise     intensity that will not cause significant arrhythmias or exacerbate symptoms and that     exercise training for 4 months will result in significant improvements in peak oxygen     consumption and quality of life, with neutral effects on the clinical characteristics.   "
249755|NCT01127100|"     Gabapentin is a first line medication and fentanyl is second line medication in neuropathic     pain. But, there is no head to head study on the efficacy of those medication in neuropathic     pain.      The hypothesis of this study is that the efficacy of the transdermal fentanyl matrix is not     inferior to the gabapentin in neuropathic pain.   "
249756|NCT01127113|"     Myocardial infarction (heart attack) is usually the consequence of rupture of a fatty     'plaque' in a heart artery. The presence of this fat and debris causes the propagation of a     blood clot and blockage of the artery. The heart muscle normally supplied by the artery     becomes deprived of oxygen and, if starved for long enough, this area of muscle dies. Much of     the heart muscle damage is caused by overactivation of inflammatory cells. Whilst     inflammation can be beneficial in healing processes, there is accumulating evidence that     overactivation of inflammatory processes contributes to further muscle damage and cell death     during myocardial infarction. We have recently developed a means of labelling human blood     cells with 'nanoparticles' of iron oxide which can then safely be reinjected into the blood     to allow the cells to be tracked and seen in the body using a conventional magnetic resonance     scanner.      In the proposed study we aim to recruit patients with recent heart attacks to perform similar     cell labelling and reinjection of labelled cells into the same volunteer's blood stream via     the arm to track the fate of the blood cells over the course of days to months. We think that     the labelled inflammatory cells will 'home' to the site of the heart attack and will be     visible using magnetic resonance imaging (MRI) of the heart. We aim not only to highlight the     role of inflammatory cells in myocardial infarction, but also propose that, if successful,     this technique could be used in the future to assess the effects of antiinflammatory     treatments currently being developed for the treatment of patients with heart attacks. The     technique could also be extended to allow labelling of other cell types, including stem     cells, to let us further understand how these cells may contribute to repair of damaged     organs including the heart.   "
249757|NCT01127126|"     E: The pharmacological effect of Bryophyllum pinnatum could be shown on uterine smooth muscle     cells, on spontaneous and oxytocin-stimulated contractions. Smooth muscle relaxation is not     only required for preventing premature labour but also for symptom's relief of overactive     bladder (OAB). According to previous preclinical and clinical studies, an inhibiting effect     of Bryophyllum on OAB is assumed.      20 women are included in this phase 2 drug study, treated with Bryophyllum pinnatum in form     of the commercially available Bryophyllum tablets into capsules (verum: 3x2capsules/day) or     lactose capsules (placebo: 3x2 capsules/day), 10 women in each group. Duration of the drug     administration is 8 weeks.      Primary endpoint is the reduction of micturitions per 24 hours (measured by filling in a     voiding dairy), secondary endpoints are the improvement of quality of life (measured by using     the King's Health Questionnaire and the ICIQ-OAB, two questionnaires, validated for the     german language, for women with incontinence), increase of the micturition volumes and     reduction of urge episodes (measured by the patients and recorded in a voiding dairy) and the     registration of adverse events during the study phase. Ethics committee approval has been     given 10th March 2010. - Trial with medicinal product   "
249758|NCT01127139|"     The fixed combination of verapamil SR/trandolapril (Tarka®) is an effective, well-tolerated     therapy for the treatment of essential hypertension in those who require more than one agent     to achieve optimal blood pressure (BP) control. The endpoint is compliance with Tarka®     treatment by number/percentage of patients continued on fixed combination Tarka therapy after     six months. This Post Marketing Observational Study will be conducted in a prospective,     single-arm, single-country, multicenter format. The investigational sites will be the     cardiologists, the doctors of internal medicine and general practicians. Since this will be a     Post Marketing Observational Study, Tarka® will be prescribed in usual manner in accordance     with the terms of the local market authorization with regards to dose, population and     indication as well as the local guidelines.   "
249759|NCT01127152|"     Circulatory failures are the main cause of admissions in the intensive care unit. It is     recommended to prescribe to these patients an intravenous injection of catecholamine to     correct this dysfunction and to keep an hemodynamic stability. Electric pumps are used to     administrate a continuous flow of drugs to patient. When a syringe of drugs ends, it is     replaced by a full syringe, it is named relay. This change may cause a flow interruption     and hypotension.      In the intensive care unit at departmental hospital (CHD) Vendee, the manual relays used in     common practice will cause hemodynamic instabilities : hypotensions in 20% cases. Since 4     years, new devices are also used to make the relays. It is smart pumps allowing to manage     automated the drug delays. This new method allows to not interrupt the drug flow. It could     reduce the occurence of hypotension. A 50% decrease of relative number of hypotension will     show that the use of automatic method is the most sure medical strategy.      Our study want to compare manual and automatic method watching the variations of medium     arterial pressure (MAP) during the fifteen minutes after the relay compared to baseline (MAP     before the relay). Noradrenalin is the catecholamine most administrated so we choose to study     only the relay for this drug.   "
249760|NCT01127165|"     The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in     children with epilepsy.   "
249761|NCT01127178|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of poly     (ADP-Ribose) polymerase inhibitor E7016 when used with temozolomide (TMZ) in patients with     advanced solid tumors and gliomas.   "
249762|NCT01127191|"     Land military missions generally combine prolonged walking/moderate-pace-running and other     physical actions such as creeping, jumping, shooting,… which are associated with the direct     carrying of high to severe loads of equipment and supplies (20-30 to 50 kg) by soldiers. For     an infantry section, typical intervention phases last about 20-24 h and combine variable     intensity grades. Consequently, military mission characteristics are an interesting     investigation field of human fatigue. Previous studies have investigated human neuromuscular     alterations after prolonged normal locomotion exercises [Millet et al., 2004, 2009], thus     the aim of this study is to characterize the neuromuscular determinants of fatigue induced by     a 24-h Simulated Military Effort (SME) and a 4-h Military Road March (MM), both performed     with high load carriage. Additionally, the consequences of fatigue on physiological and     biomechanical parameters of locomotion will be investigated.   "
249763|NCT01127204|"     The MONOD trial aim to evaluate the implementation of early antiretroviral treatment     strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the     initial proposed regimen after a successful one year treatment. The initial treatment is     AZT-3TC-LPV/r twice a day. After one year, the children will be randomized in one of the     following : arm 1-reference AZT-3TC-LPV/r twice daily; arm 2-simplified ABC-3TC-EFV once     daily.      The perspective of this project is to identify antiretroviral strategies to improve treatment     access and adherence for children in sub-saharian Africa.   "
249764|NCT01127217|"     The purpose of this study is to evaluate the blood pressure lowering effects of an     amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2     hypertensive patients.   "
249765|NCT01127230|"     This scientific study is meant to establish correlation in Stromal Vascular Fraction (SVF)     cell counts between our manual method of harvesting and Cytori's Celution automated system.      Future scientific studies involving Adipocyte Derived Regenerative Cells (ADRCs) will be     based on SVF cell counts from the more economical manual method of harvesting if this study     shows good correlation.   "
249766|NCT01127243|"     The purpose of this study is to determine if women subjected to laparoscopic supracervical     hysterectomy in a day-case setting would be less satisfied with the length of hospital stay     when compared with women who had an overnight stay following their surgical procedure. The     null hypothesis was that there was no difference in satisfaction with length of hospital     stay.   "
249767|NCT01127256|"     The purpose of this study is to compare the efficacy and safety of zonisamide with     carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.   "
249768|NCT01127269|"     Primary Objective:      Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) < 7% with no severe or     nocturnal hypoglycemic episodes at 6 months      Secondary Objectives:        -  Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months        -  Insulin glargine dose at 3 and 6 months        -  Hypoglycemic episodes (all types)   "
249769|NCT01127282|"     Influenza continues to inflict an important burden on health-care systems. The 2009 H1N1     influenza virus first appeared in Mexico and the United States in March and April 2009 and     has swept the globe with unprecedented speed.      The aim of this study is to evaluate effect of supplement vitamin on the clinical course of     patients with acute respiratory illness suspected novel H1N1 infection.   "
249770|NCT01127295|"     This is a biomedical study of interventional type, multicenter, inter-regional.      Patients with hormono-depending breast cancer, for which an indication of adjuvant     hormonotherapy treatment (according to the current treatments) was retained, will be enrolled     in this study. The main objective is to estimate the correlations between pharmacokinetic and     pharmacogenetic parameters of adjuvant hormonal breast cancer treatment, during the first 3     years.   "
249771|NCT01127308|"     This is single dose study of radiolabeled [14C]-ertugliflozin (PF04971729, MK-8835) in     healthy male volunteers to study the absorption, distribution, metabolism and elimination of     ertugliflozin.   "
249772|NCT01127321|"     The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult     subjects with moderately to severely active systemic lupus erythematosus (SLE).   "
249773|NCT01127334|"     Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator )     for cardiac resynchronization therapy there is approximately one-third that do not respond.     We believe that by using a simple technique that includes routine echocardiography that are     normally performed in these patients could help us better understand how to program their     device to reach better optimization.   "
249774|NCT01127360|"     Age-related macular degeneration (AMD) is the most common cause of blindness in individuals     over 50 years of age. Bevacizumab and ranibizumab are two agents developed by the American     pharmaceutical corporation Genentech, both of which inhibit blood vessel growth factors.     These drugs, when injected intraocularly, reduce the pathological growth of blood vessels in     the macular area of the eye. Bevacizumab (Avastin) is an antibody developed for intravenous     treatment of metastasized colon cancer. Ranibizumab (Lucentis) is an antibody fragment     developed from a similar antibody. It was introduced 2006 as an effective treatment for wet     AMD. Treatment costs are, however, up to 50 times higher compared to use of bevacizumab.     Avastin has shown similar effects to ranibizumab, and has been used off-label in many     countries, both before and after Lucentis received approval. There is thus a recognized need     for large randomized studies to garner proper scientific proof of Avastin's effectiveness     regarding exudative AMD.      LUCAS is a randomized multicenter study, performed in Norway, comparing ranibizumab and     bevacizumab use for AMD. The goal of the study was to demonstrate if the two agents were     equivalent regarding both efficacy and safety. A total of 441 patients with objective     evidence of wet AMD were randomized to a double-blind treatment with ranibizumab or     bevacizumab over the course of 2 years. The treatment interval was determined by a Treat and     Extend protocol.   "
249775|NCT01127373|"     This study is being performed to understand the safety of a new radiation treatment called     Multi-Beam Intensity Modulated Radiation Therapy ( IMRT). Currently, the standard way of     giving radiation is with simplified IMRT, which uses only 2 beams of radiation.     Multi-beam IMRT works by using 6-12 small radiation beams to give a more tailored or     customized radiation dose to the breast, chest wall, and the lymph nodes. At the same time,     multi-beam IMRT may allow the dose to the heart, lungs, and nearby tissue to be lowered,     especially when the internal mammary lymph nodes need to be targeted by radiation.   "
249813|NCT01127867|"     This study aims to determine if a supplement of an omega-3-fatty acid (docosahexaenoic - DHA)     lowers inflammation in human fat tissue thereby lowering estrogen production and the     potential risk for breast cancer. The investigators also aim to study how this occurs to     discover the basis for other potential treatments to lower estrogen production in fat tissue     and decrease the risk of breast cancer.   "
249814|NCT01127880|"     The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients     with chest tubes for management of thoracic injuries in the reduction of the incidence of     empyema as compared to placebo.   "
249815|NCT01127893|"     An evaluation of the long term safety of tanezumab when administered by subcutaneous     injection every 8 weeks for up to 64 weeks   "
249776|NCT01127386|"     Cancer cachexia syndrome (CCS) is frequent, causing high morbidity and mortality in affected     ones. The mechanism is catabolism caused by the tumour. CRP is a surrogate marker for     catabolism. There are no effective treatment options against CCS. Lenalidomide, a derivate of     thalidomide, is an immunomodulatory drug (IMiD®). One of its' main effect is a decrease in     inflammatory cytokines. As CCS treatment, thalidomide has shown in a randomized controlled     trial to stabilize lean body mass. The effect of lenalidomide in solid tumour patients was     negligible although, there might be a decrease in tumour progression. However, even if     lenalidomide may be uninteresting as an anticancer treatment it might affect CCS dynamics.     Respective data are currently lacking. Therefore, a dose level where an anticancer effect     could be expected was chosen (group A). Relevant anti-inflammatory effect may occur below the     commonly used doses to achieve tumour control, which is expected to be the main anti-cachexia     effect. Therefore, a second CRP-response guided treatment arm (group B) was chosen.      Hypothesis: To test whether the response rate under new standard basic cachexia management     will be at the estimated 5% and with lenalidomide (either fixed dose or CRP-guided dose) in     addition to basic cachexia management at least 25%.      The primary objective of this study is to assess the efficacy of lenalidomide on lean body     mass and handgrip strength in advanced solid tumour patients with inflammatory CCS.   "
249777|NCT01127399|"     The prevalence of obesity and asthma has significantly increased over the past two decades.     The purpose of this study is to try and understand the mechanism by which obesity leads to     airway hyperresponsiveness (AHR), one of the defining features of asthma. This research is     being done to determine how weight or body size affects airway size and airway smooth muscle     (ASM) tone and function. The goal of the study will be to look at if and how, weight might     affect lung functioning.      The investigators hypothesize that low lung volumes in obesity lead to AHR by reducing airway     caliber causing increased ASM tone with impairment in deep inspiration (DI) response similar     to what is seen in asthma.   "
249778|NCT01127412|"     The purpose of this study is to investigate whether stimulating physical activity during the     first year of life influences growth and body composition, and stimulates motor activity and     motor development   "
249779|NCT01127425|"     A blinded randomized trial. Length of hospital stay, nursing hours and recovery after     laparoscopic versus open colonic resection without fast track.   "
249780|NCT01127438|"     The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol     disodium) and to determine whether a dose lower than currently approved can provide effective     moderate sedation required to complete diagnostic or therapeutic procedures.   "
249781|NCT01127451|"     The purpose of this study is to determine whether Patients with Stage IIIC and Stage IV     Melanoma experience benefit when treated with Denileukin diftitox in two different dosing     schedules.   "
249782|NCT01127464|"     DCVax-001 is a recombinant protein vaccine designed to prevent and potentially treat human     immunodeficiency virus (HIV) infection. The vaccine is composed of a fusion protein     containing a human monoclonal antibody specific for the dendritic cell receptor, DEC-205     (CD205), and the HIV gag p24 protein. The vaccine is designed to target HIV antigens directly     to endocytic pathways in dendritic cells (DCs) that allow for efficient processing and     presentation of multiple HIV peptides on both MHC class I and II products, which will induce     HIV-specific CD8+ and CD4+ T cells. This vaccine candidate must be combined with appropriate     immunostimulants (adjuvants) to induce immunity to the antigen. In the proposed clinical     trial we will use poly ICLC (Hiltonol) from Oncovir, Inc as the adjuvant.   "
249783|NCT01127477|"     The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for     restoration and maintenance of hemodynamics during the investigational period in patients     undergoing major elective surgery. Up to 50 mL 6% hydroxyethyl starch/kg body weight will be     administered from start of surgery until two hours after end of surgery. The study hypothesis     is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely     administered up to the dose limit.   "
249784|NCT01127490|"     The purpose of this study is to examine the characteristics of the nerves and the small veins     in the skin of people with fibromyalgia. The investigators will then use this information to     identify possible processes in the skin that may help explain why some people feel pain     relief with the study drug (duloxetine) and others do not.      Duloxetine affects certain chemicals in the brain called neurotransmitters. An abnormality in     these chemicals is thought to be related to fibromyalgia. Duloxetine is a selective serotonin     and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of     depression. Duloxetine is approved for sale in the United States by the Food and Drug     Administration (FDA) for the treatment of fibromyalgia.   "
249785|NCT01127503|"     This is an exploratory clinical investigation. The objectives of this study are to evaluate     the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the     treatment of psychosis in patients with velocardiofacial syndrome (VCFS).   "
249786|NCT01127516|"     The hypothesis of this investigation is that rate of isolation of resistant nosocomial     pathogens can be explained by a combination of measures that include, among other things,     antimicrobial drug use, infection control efforts, patient mix and antimicrobial stewardship     efforts. The short term goal of this investigation is to improve our understanding of the     relationships between antimicrobial stewardship program efforts (and actual antimicrobial     drug use), and infection control efforts to the incidence rates of MSSA, MRSA, h-VISA and     SA-MICcreep. The long term goal of this investigation is to design interventions that will     improve antimicrobial drug use and decrease cross-transmission of resistant bacteria,     resulting in a decrease in the rates of infection caused resistant hospital organisms.   "
250200|NCT01124851|"     The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652     given once daily to people with excessive daytime sleepiness. Subjects will be randomized to     either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.   "
249788|NCT01127542|"     The majority of patients with CLL are diagnosed with early stage disease (Binet stage A or     Rai stage 0/I). Standard management of such patients is observation, and with median age at     diagnosis of 72 and median time to progression of >5-10 years, many will never require     treatment. In contrast, a proportion of patients have more aggressive disease, and over the     last decade, a number of molecular factors have been identified that may be used to identify     patients with poor prognosis disease . Each is associated with shortened time to treatment     (typically less than 3 years in patients with 2 of more factors), reduced survival, with in     the case of p53/ATM inactivation, resistance to treatment. Whether it is possible to improve     the outcome of patients with CLL and adverse prognostic factors by early intervention with     treatment is unknown. Several trials in the 1980's demonstrated that treatment of stage A CLL     with conventional chemotherapy (chlorambucil) did not alter the natural history of the     disease, although none of these studies stratified patients according to risk. The choice of     alternative potential therapeutic agents is limited; they should be effective in patients     with adverse prognostic factors, have acceptable toxicity, be able to overcome the drug     resistance associated with p53/ATM inactivation and ideally be orally administered. Two     recent phase II trials have demonstrated that Lenalidomide is effective in the treatment of     relapsed/refractory disease. Importantly, both studies included a high proportion of patients     with adverse prognostic factors including p53 inactivation. The principle objective of this     study is to investigate the efficacy of Lenalidomide in achieving disease response (complete     remission and clearance of minimal residual disease) in patients with poor risk early stage     disease, together with assessment of safety and tolerability.   "
249789|NCT01127555|"     The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil,     leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer     who had failed gemcitabine.   "
249790|NCT01127568|"     Objective: To use propranolol to treat established chronic post traumatic stress disorder     (PTSD) by reducing reconsolidation of the reactivated trauma memory.      Hypothesis: A series of treatments with propranolol, in comparison to placebo, will produce a     significant reduction in PTSD symptom severity in participants with chronic PTSD.      Study Design: This is a double-blind, placebo-controlled, randomized study. Methodology:     Twenty-five participants per group with chronic PTSD will be recruited. On their first visit     psychodiagnostic and psychometric evaluation will take place. In addition, script-preparation     for the script-driven imagery procedure will occur. Following this, the participants will     return each week for a period of 6 weeks to participate in the reactivation sessions with     propranolol or placebo (participants assigned to the propranolol condition will receive     propranolol throughout, and participants assigned to the placebo condition will receive     placebo throughout). Two weeks later, the participants will return for a follow-up of the     psychodiagnostic and psychometric evaluation, as well as psychophysiological assessment using     script-driven imagery procedure.      Data Analysis: A two-factor analysis of variance (ANOVA) for repeated measures will be     performed on study completers. The Drug factor will have two levels: propranolol and placebo.     The Time factor will have two levels: pre-treatment and post-treatment. We predict a     significant Drug x Time interaction, more precisely a greater decrease in PTSD severity in     the propranolol than in the placebo group. The psychophysiological data will be contrasted to     a normative cutoff score for PTSD.   "
249791|NCT01127581|"     The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200     microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone     Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and     induction of labor.   "
249792|NCT01127594|"     The purpose of this study is to determine the safety profile of intra-arterial temozolomide     administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities     associated with this treatment. This study also aims to determine the maximum tolerated dose     of intra-arterial administration of temozolomide during ILI that will be used in a phase II     trial.   "
249793|NCT01127607|"     It is now well recognized that Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic     disorder of childhood that extends into adulthood for many individuals. A number of     impairments in daily life functioning have been identified in adults with ADHD, including     marital distress, risky driving, and using less effective parenting practices (e.g., Barkley,     2006).      Specifically, some parents with ADHD have been found to use inconsistent discipline, less     parental involvement, and less positive reinforcement with their children compared to parents     without ADHD (e.g., Chen & Johnston, 2007; Chronis-Tuscano, Clarke, Rooney, Diaz, & Pian,     2008). While there is some evidence that stimulant medication improves parental functioning     for adults with ADHD, only one study has specifically explored the use of stimulant     medication and parenting(Chronis-Tuscano, Seymour, Stine, Jones, Jiles, Rooney, et al.,     2008).      The purpose of this study is to explore whether or not the stimulant medication,     lisdexamfetamine, improves parent functioning. Measures of parenting behavior, parental     psychosocial functioning, and child psychosocial functioning will be collected. It is     hypothesized that lisdexamfetamine will be associated with some improvement in these     assessments.   "
249794|NCT01127620|"     Double-blind phase: The objective of the study was to evaluate the efficacy and safety of     Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of perennial allergic     rhinitis.      Open-label Phase: The objective of this extension was to evaluate the long-term safety of     Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis   "
249795|NCT01127633|"     This study is an open-label extension study in Alzheimer's patients who have completed     participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN     (NCT00904683).   "
249796|NCT01127646|"     The main purpose of the study is to help to understand the effect on children and adolescents     who are stable on treatment with atomoxetine or osmotic-release oral system (OROS)     methylphenidate for attention-deficit/hyperactivity disorder (ADHD) of not taking the     medication for a maximum of 6 days over a 28-day study treatment period.   "
249797|NCT01127659|"     The purpose of this study is to examine the effect of having testosterone deficiency in men     with diabetes and with obesity. The study will also evaluate the effect of testosterone     therapy. This will be done by comparing the changes in several body response indicators     following treatment with testosterone in diabetic or obese-non diabetic men with low     testosterone levels and comparing them to diabetic or obese-non diabetic men with low     testosterone who are not treated with testosterone.   "
249835|NCT01128153|"     The purpose of this study is to determine whether the addition of saxagliptin to a patient's     combination treatment of metformin and sulfonylurea for a 24 week period will provide better     control of the patient's type 2 diabetes and will be well tolerated.   "
249798|NCT01127672|"     The purpose of this investigator-initiated study is to clinically evaluate the efficacy of a     new treatment for plantar fasciitis. This treatment consists of a platelet rich plasma     injection into the origin of the plantar fascia. It is thought that plasma rich plasma     injection will dramatically improve outcomes for patients suffering from plantar fasciitis.      Subjects will be randomized by choosing a slip of paper from an envelope. This process will     randomize 25 patients to the experimental group, and 25 patients to the control. The     experimental group will undergo a blood draw, allowing for an injection of platelet rich     plasma into the origin of the plantar fascia. The control group will undergo a corticosteroid     injection into the plantar fascia as the sole treatment. Patients will be followed for three     months for pain, and will fill out questionnaires at the initial visit prior to receiving the     injection, as well as six and twelve weeks post injection.      These questionnaires will give insight into functionality and pain changes that the plantar     fascia is experiencing due to treatment.      Subjects will be outpatients. Subjects may include employees, students, minorities, and     elderly, although no subsets of these will be formed.      Subjects will be between 18 and 89 years of age.      In total, subject participation will last approximately 3 months.   "
249799|NCT01127685|"     The objective of this clinical trial is to in determining weight-bearing deficits following     anterior cruciate ligament reconstruction.   "
249800|NCT01127698|"     The Swedish Mammography Cohort began in 1987-1990, when 66,651 women living in two counties     in central Sweden completed a mailed questionnaire that included items about their diet,     parity, age at first child's birth, history of breast cancer in family, weight, height, and     education. Follow-up questionnaires have been sent out in 1997 and in 2008-09.   "
249801|NCT01127711|"     The Cohort of Swedish Men began in 1997, when all men born between 1918 and 1952 and residing     in two counties in central Sweden received a questionnaire including about 350 items     concerning diet and other lifestyle factors. A second questionnaire was sent out in 2008-09.   "
249802|NCT01127724|"     Background: The frequency of recurrent aphthous stomatitis (RAS), the most common oral mucosa     lesions seen in primary care, is up to 25% in the general population. Sublingual vitamin B12     treatment, 1000 mcg per day for 6 months was found to be effective for patients suffering     from RAS, regardless of the serum vitamin B12 level. However, the optimal therapeutic dose of     vitamin B12 treatment remains unclear.      Working hypothesis and aims:      Aim-To assesses the influence of different vitamin B12 treatment doses on the frequency and     severity of RAS episodes.      Working hypothesis- The group receiving the higher dose of vitamin B12 treatment will have     the lower frequency and severity of RAS episodes; the reaction will be faster.      Methods: randomized, double blind, intervention study.      Study population: 75 patients in three groups (total of 225 patients):      Group I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months Group     II- will receive sublingual vitamin B12 treatment, 100 mcg per day for 6 months Group I- will     receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months Study design: Study     participates will be followed through three study periods: The first period- three months     prior to receiving active treatment, the second period- six month of active treatment (with     randomization to study groups), and the third period- three month after finishing active     treatment. Frequency and severity of RAS episodes will be recorded by the patient with     aphthous diary that will be filled daily during all study period (12 months).      Expected results: This study will allow us to identify optimal dose of vitamin B12 treatment     that will achieve faster and longer remission of RAS episodes.      Importance: This is a very common problem in the population. Study results will help to     identify optimal doses of vitamin B12 needed to treat RAS.      Probable implications to Medicine: study results are supposed to give faster and better     treatment for RAS episodes   "
249803|NCT01127737|"     Using focus group and cognitive interviews with organ transplant recipients, the     investigators developed interactive workbooks: a) prevention by sun protection b) early     detection by skin self-examination (SSE). The investigators hypothesis is if the patient     learns by acquiring skills in a favorable environment, then the patient may reduce their     anxiety, enhance self-efficacy and perform self-management by SSE and sun protection. The     investigators also evaluate existing internet sources of primary and secondary prevention of     skin cancer for organ transplant recipients.   "
249804|NCT01127750|"     This study will assess tolerability and safety and health outcomes in relapsing MS patients     taking FTY720.   "
249805|NCT01127763|"     This study investigates the effectiveness of combination of carboplatin and investigational     agent RAD001 in triple-negative breast cancer.   "
249806|NCT01127776|"     The purpose of this study is to evaluate of functional tests and clinical findings with APOS     System treatment in patient after bi-trimalleolar fracture of ankle. These functional changes     will be evaluated AOFS, FAOS, SF36 and WOMAC scores, walking laboratory GAITRite and clinical     examination.   "
249807|NCT01127789|"     The purpose of this study is to study motor learning and recovery of patients with brain     damage caused by traumatic brain injury or stroke with transcranial direct current     stimulation (tDCS). It is hypothesized that anodal tDCS on the lesion side and/or cathodal     tDCS on the healthy side of motor cortex could improve the recovery of motor function such as     learning.   "
249808|NCT01127802|"     The purpose of this study is to explore the changes of functional status, symptoms distress     and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery.   "
249809|NCT01127815|"     Pancreatic cancer is a disease with an extremely poor prognosis. Such poor results are     largely due to a high incidence of local or peritoneal recurrence even after curative R0     resection. If occult microscopic metastasis or residual cancer could be predicted correctly     and identify the high risk of peritoneal recurrence, we may have chance to treat these     patients by different multimodal locoregional or adjuvant therapy to improve the treatment     outcome.   "
249810|NCT01127828|"     To determine the effect of cultura probiotic yoghurt on number of responders to treatment     during 8 weeks of treatment in comparison to placebo. To determine the effect of cultura     yoghurt on change in total score of (IBS) irritable bowel syndrome severity index during 8     weeks of treatment in comparison to placebo in IBS out patients.   "
249811|NCT01127841|"     Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and     response complete not confirmed.   "
249812|NCT01127854|"     Recent investigations from this group have identified that genetic variants of genes     associated with monogenic forms of nephrolithiasis are expressed in idiopathic calcium     oxalate kidney stone patients and could influence stone forming risk. Utilizing patient     samples from the Mayo Clinic Florida Kidney Stone Registry, we will demonstrate that     expression of these heterozygous mutations in idiopathic nephrolithiasis act as genetic     modifiers of disease presentation increasing risk of kidney stone formation. Complimented by     the analysis of environmental and lifestyle risk factors, these studies will define     environmental and genetic susceptibility factors involved in kidney stone formation and     reoccurrence.   "
249837|NCT01128179|"     To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo     on serum intact Fibroblast Growth Factor 23 (FGF23) levels.   "
249817|NCT01127919|"     Obesity established in adolescence strongly predicts obesity for the remainder of adult life,     and the consequences are potentially devastating, characterized by a lifelong burden of     co-morbid conditions and depression. This study will provide an exposure to physical activity     that is designed to teach and empower sedentary college age individuals to become physically     active. The investigators will evaluate whether such exposure can result in lasting changes     in exercise behavior and body composition. The study will also provide a better understanding     of the genetic factors that influence persistence in an exercise program and that influence     whole body response to exercise training. Altering the course of obesity in adolescence has     the potential to reduce the adult prevalence of obesity and consequently attenuate the public     health burden of overweight and obesity in the investigators population.   "
249818|NCT01127932|"     This is a 2-year study designed to: (1) adapt and refine an existing cognitive-behavioral     treatment (CBT) intervention to decrease suicidal thoughts and behaviors for use in Substance     Use Disorder (SUD) treatment settings, and (2) conduct a pilot randomized controlled trial     with 50 patients in treatment for SUDs comparing the CBT intervention to an enhanced control     condition. Through this pilot randomized controlled trial, the investigators hope to not only     obtain information about the feasibility of implementing these procedures in residential SUD     treatment, but to also determine whether this intervention decreases the level of suicidal     ideation, suicide attempts, hopelessness, and frequency of substance use relative to the     control condition.   "
249819|NCT01127945|"     This is a prospective, single-center, randomized, controlled, open-label, pilot study to     evaluate the effectiveness of high dose statin loading in acute heart failure patients.   "
249820|NCT01127958|"     The main objective of the study is to determine whether PCI for in-stent restenosis with a     drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6     month follow up.   "
249821|NCT01127971|"     This is an Aurora Health Care system registry of patients receiving accelerated partial     breast irradiation and external beam.   "
249822|NCT01127984|"     The aim of this study is to demonstrate the efficacy of fibrin sealant (Tissucol-Baxter) in     preventing pocket haematoma and subsequent complications in patients undergoing pacemaker or     ICD implantation/replacement which cannot discontinue dual antiplatelet therapy (i.e. ASA and     clopidogrel, ASA and prasugrel) or anticoagulant therapy (i.e. warfarin, heparin, low     molecular weight heparin).      Fibrin-based sealant is available for local haemostasis. A recent study (Milic DJ et al, 2005     Europace, 7: 374-379) has shown the efficacy of the fibrin sealant in prevention of pacemaker     pocket haematoma in 40 patients undergoing pacemaker implantation who are receiving     anticoagulant treatment.      Patients with dual antiplatelet therapy (DAT) are prone to a high risk of bleeding during     surgical procedures. Thus, the routine use is the discontinuation of DAT al least 4-7 days     before the intervention. This practice may result in a high risk of thrombotic events in     patients with coronary stenting.      Recently, in our Center we started the use of a fibrin sealant for local haemostasis     (Tissucol Baxter), and the investigators observed a reduction in the incidence of pocket     haematoma complication, the need of vacuum drainage system, and the reduction of hospital     stay.   "
249823|NCT01127997|"     Second-meal phenomenon denotes the effect of a prior meal in decreasing the rise in blood     glucose after a subsequent meal. This phenomenon occurs in normal subjects while it is not     clear whether it is also observed in type 2 diabetic patients. This study aims to define     whether the second-meal phenomenon occurs in type 2 diabetic patients. We will also seek for     the mechanism.   "
249824|NCT01128010|"     Immune dysregulations, including cytokines and chemokines secretions occurs in alcoholic     liver disease. Serum levels and liver expression of CCL2 are increased in patients with     alcoholic hepatitis but the role of this chemokine in the pathogenesis of alcoholic liver     disease is nevertheless unknown. The aim of the study is to analyze plasma level and liver     expression of CCL2 and their relation with liver disease severity and inflammatory infiltrate     in our cohort of alcoholic patients. We studied also the association between -2518 CCL2     polymorphism and the severity of alcoholic liver disease.   "
249825|NCT01128023|"     Cardiovascular (CV) disease is the leading cause of death in Canada. Fifty percent of all     Tc-99m used in nuclear medicine is for the diagnosis of coronary artery disease (CAD) with     SPECT myocardial perfusion imaging (MPI). The reduced supply of Tc-99m requires other tracers     to be investigated. Tl-201 SPECT is available but generally accepted to be inferior to     Tc-99m. Rubidium (Rb-82), a nonreactor produced tracer, is believed to have superior accuracy     compared to Tc-99m and Tl-201 SPECT, with 5-20 times lower radiation dose. In the U.S. Rb-82     generators have been FDA-approved since 1989 and are used increasingly for CAD diagnosis, but     are still considered investigational in Canada.      Objectives: To demonstrate that Rb-82 PET MPI is i) an accurate, cost-effective alternative     to Tc-99m; ii) superior to Tl-201; iii) can be implemented in multiple Canadian centres for     the diagnosis and management of CAD. Short term clinical outcomes of Rb-82 will be evaluated     and compared to Tc-99m and Tl-201 SPECT MPI across Canadian imaging centres.      Plan: Rb-ARMI is an innovative multidisciplinary, multi-centre imaging research initiative     that builds on existing collaborative networks and Canadian industry partnership (DRAXIMAGE).     Rb PET will be implemented, standardized and validated in 4 overlapping phases over 2 years,     at 10 Canadian Centres.      Impact: This project meets the expected goal to lead to clinical trial applications and     clinical validation studies which compare novel radiolabeled probes with those in current     practice, and to bring a new radiopharmaceutical to the clinic within a short time frame.     Increased use of Rb-82 PET MPI has the potential to reduce the demand for Tc-99m by 10-40%,     effectively increasing the available supply for other procedures, and improving the standard     of care for many Canadians at risk of heart disease.   "
249826|NCT01128036|"     The purpose of this study is to determine if the forehand location for sensor placement has     less episodes of signal dropout than the finger sensor location. In addition, this study will     evaluate two finger sensors, which utilize different technology to compare signal quality.   "
249827|NCT01128049|"     Compare the objective tear film dynamic measurements in three different populations (MGD     [Meibomium Gland Dysfunction], ADDE [Aqueous Deficient Dry Eye] and normal/control [non-dry     eye]) and the subjective experience before and after instilling a single drop of saline in     each eye.      Currently available office-based tests for dry eye do not reliably correlate with patients'     subjective symptoms. This study is interested in assessing how individuals with these two     different ocular surface diseases compare with the normal population when measured     objectively using two different instruments.   "
249848|NCT01128335|"     This study will assess the safety and efficacy of different doses of sotrastaurin when     combined with tacrolimus for the prevention of acute rejection after de novo liver     transplantation.   "
249828|NCT01128062|"     Canthaxanthine is a naturally occurring carotenoid that has been a popular over-the-counter     oral artificial tanning agent in Europe, Canada, and Australia since 1979. It is also used at     low dosage as a food-colouring agent and as a therapeutic agent for photosensitivity     disorders such as erythropoietic protoporphyria. Canthaxanthin retinopathy was first     described in 1982 by Cortin et al. In Germany the office of the federal board of health     refused the permit for oral tanning agents containing canthaxanthine in 1985. At that time     the long-term course of the disease was not known. 25 years later the investigators did these     long-term follow-up examinations.   "
249829|NCT01128075|"     This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to     evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects     with relapsing multiple sclerosis (RMS).      Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the     eligibility criteria during a screening period of up to 28 days will be provided with an     electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.      The main purpose of this study is to evaluate treatment adherence for subjects with RMS over     24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose     cartridge.   "
249830|NCT01128088|"     Keyhole bowel surgery provides the patient with an improved outcome following surgery in     comparison to more traditional surgery requiring a large cut. In order to further improve     outcomes there are several variables that must be controlled before, during and after the     operation. These variables are the correct pain relief, accurate control and measurement of     the fluid that is given during the operation and the subsequent mobility following surgery.     Previous research has already identified that an enhanced recovery program (careful control     and structure to the patients journey) will reduce the length of stay and complications after     an operation. Currently an integral part of the enhanced recovery program requires the use of     an epidural (a thin tube in the spine) to provide continuous pain relief for up to 48 hours.     Through research previously undertaken at the MATTU the investigators have shown that an     epidural can lead to an increase in the length of stay and a delay in the return to normal     bowel function. A reason for the use of an epidural is to suppress the stress response.      The investigators aim to recruit patients from outpatient clinic undergoing keyhole bowel     surgery in one unit and randomize them to receive one of two different pain relief methods     after the operation. Patients will follow the same care as standard patients but their pain     relief will differ between two already well established modalities. They will also receive     different intravenous fluids. Blood will also be drawn at various intervals immediately after     the operation for future analysis. The trial will be funded by the MATTU and will run for     approximately 18 months. This trial will enable us to establish the stress response in the     four groups and correlate it to the patient's outcome with an aim to refining the enhanced     recovery program.   "
249831|NCT01128101|"     Several studies indicate that chronic kidney disease patients give a high cardiovascular risk     and have an intrinsic relationship with hypertension and cardiomyopathy: characterized by     left ventricular hypertrophy and interstitial fibrosis. The reversal of left ventricular     hypertrophy is associated with increased life expectancy in these patients. The renin     angiotensin aldosterone system plays an important role in blood pressure control. Even     patients using converting enzyme inhibitors inhibitors or angiotensin II blockers may     experience the so called aldosterone breakthrough phenomenon (inappropriately called     aldosterone escape). This phenomenon is documented in patients with heart disease and in     chronic kidney disease. Spironolactone is a synthetic steroid that acts as an antagonist of     aldosterone, which has historically avoided in chronic kidney disease patients, given the     risk of hyperkalemia. However, its active metabolite, canrenone and spironolactone, are able     to antagonize the binding of ouabain, a Na+/K+ATPase inhibitor, to its receptor. The     Na+/K+-ATPase inhibition results in changes in sodium gradients, and increases the calcium     influx through the transporter Na+/Ca+ in specific regions of the membrane. Spironolactone     and canrenone in previous research were able to reverse left ventricular hypertrophy in     chronic kidney disease patients on conservative treatment, which turn this drug and its     metabolite potential tools for reversion of left ventricular hypertrophy in chronic kidney     disease. The aim of this study is to verify the safety, tolerability and efficacy in the     reversal of target organ damage from the use of spironolactone added to conventional     antihypertensive therapy in chronic kidney disease patients on hemodialysis, in addition to     measuring its ability to reduce left ventricular hypertrophy and arterial stiffness indices.     Interventional randomized, double-blind, placebo-controlled study comprising two groups: one     that will take 25mg of spironolactone associated with conventional antihypertensive therapy     and another that will take spironolactone placebo associated with conventional     antihypertensive therapy. Each group will consist of 30 patients. Clinical and laboratory     investigations, as well as home monitoring of blood pressure, echocardiography, determination     of pulse wave velocity, augmentation index, and central blood pressure measurement of serum     aldosterone will be are evaluated before and after treatment that will last 12 months.   "
249832|NCT01128114|"     The primary objective of this study is to evaluate the broad clinical benefit of dosing     Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial     response to existing therapy. Clinical benefit will be assessed with the Clinical Global     Impression-Clinical Benefit (CGI-CB) score, according to a classification based on the     principles outlined in the CGI efficacy index. Improvement in clinical benefit will be     defined as a decrease from baseline in CGI-CB.   "
249833|NCT01128127|"     Background      Despite the low prevalence of serious complications associated with non-steroidal     anti-inflammatory drugs (NSAIDs) use, there is a widespread use of gastroprotective proton     pump inhibitors (PPIs) in order to prevent adverse effects. Inappropriate prescribing of PPIs     includes overprescribing for inappropriate indications and the misuse of first choice in     their class in terms of efficacy, safety and cost. A series of recommendations, based on the     best available scientific evidence, has been established to justify prophylaxis with PPIs     associated to NSAIDs. Therefore, there is the need to encourage the incorporation of this     knowledge to guide decisions of physicians with the objective of improving patient health and     sustainability of the Public Health Service. Although since long ago there is a great concern     regarding rational use of drugs, the available evidence for the most appropriate strategies     to improve prescribing is scarce. Passive dissemination of research findings are generally     ineffective and at best result in small changes in practice. Multifaceted intervention     targeting different barriers to change are more likely to be effective than single     intervention.      Objectives      The objective of this study is to evaluate the effectiveness of two educational multifaceted     strategies aimed at improving PPIs prescription associated to NSAIDs use in primary care. We     will also compare the cost-effectiveness of such strategies.      Hypothesis      It is hypothesized that a quality improvement intervention directed to primary care     physicians will decrease inappropriate PPIs prescriptions associated to NSAIDs prescription.      Methodology      A three-arm prospective quasi-randomized controlled trial will test the effectiveness of two     strategies for improving PPI prescription associated to NSAID in primary care context. Three     of the Canary Islands will be selected and randomized to either a experimental multifaceted     intervention (group education+audit-feedback+CCDSS) group, a experimental multifaceted     intervention (audit-feedback+CCDSS) group, or a control group (usual intervention). From each     of these islands, 6-8 primary care centers will be randomly selected to received the     intervention practices. All family physicians working at each randomly selected primary care     center were mandatorily included. Primary outcome measure is reduction of inappropriate PPI     prescription. The efficacy of the intervention will be examined within a 3, 6 and a 12 month     follow up.   "
249834|NCT01128140|"     This study will develop and test a brief telephone-delivered motivational enhancement     intervention for substance abusing military personnel who are not currently in treatment. The     hypotheses being tested are that this intervention will prompt a willingness to participate     voluntarily in a self-appraisal of substance abuse behavior and consequences, self-initiated     change or enrollment in a treatment or self-help program, and cessation of abuse of alcohol     or other drugs.   "
249838|NCT01128192|"     This clinical study will attempt to find out why in early studies in healthy volunteers,     injections under the skin of pasireotide were associated with temporary increases in both     fasting and post-meal glucose levels, along with possible increases in insulin and glucagon     levels. Glucose refers to the amount of sugar in your blood and insulin and glucagon levels     are amounts of hormones that lower and raise blood sugar.      The purpose of the study is to evaluate the effects of pasireotide on insulin resistance and     secretion. Insulin is a natural hormone made by the pancreas (a gland inside the abdomen)     that controls the level of sugar in the blood. Insulin permits cells to use sugar for energy.     Insulin resistance is the condition in which higher than normal amounts of insulin are     necessary to allow the sugar to enter the cells. Insulin secretion refers to the amount of     insulin produced by the body and released in the blood. Glucagon is a hormone (chemical     substance produced by the pancreas gland in the body) which increases blood glucose.   "
249839|NCT01128205|"     The objective of this study is to evaluate the level of control of cardiovascular disease     risk factors, including blood pressure, blood lipid, and blood glucose, in out patients with     type 2 DM in 6 representative regions in China: Northeast, North, East, South, Southwest and     Northwest, measured by,        1. Proportion of patients reaching adequate control of blood glucose        2. Proportion of patients reaching adequate control of blood glucose and blood pressure, or          blood glucose and blood lipid        3. Proportion of patients reaching adequate control of all 3Bs, i.e. blood glucose, blood          pressure, and blood lipid.   "
249840|NCT01128218|"     Extent of resection is a very important prognostic factor affecting survival in individuals     diagnosed with a malignant glioma. However, the infiltrative nature of the malignant glioma     tumor cells produces indistinct borders between normal and malignant tissues, and the lack of     easily identifiable tumor margins confounds attempts at total resection. The investigators     propose to identify the borders of malignant gliomas intraoperatively using oral     5-aminolevulinic Acid (5-ALA) which results in fluorescence of the malignant cells and     thereby provide an opportunity for more complete tumor resection.      When exogenous 5-ALA is provided at increased concentration the tumor cells will become     fluorescent under ultraviolet light. This feature identifies the tumor cells intraoperatively     and facilitates complete resection.      Data collection will include measurement of dose-limiting toxicity, tumor fluorescence, and     tumor density. Data analysis will evaluate toxicity, sensitivity, and specificity of 5-ALA.     Time-to-progression, one year survival rate and total survival will be measured as a function     of the extent of resection. (Details below in Detailed Description.)      Following completion of the phase 1 portion of this trial, an additional 15 subjects will be     entered at the recommended phase 2 dose level in order to further define the above parameters     at the recommended phase 2 dose level.   "
249841|NCT01128244|"     Chronically inadequate B6 nutritional status is associated with aberrant one-carbon (1C)     metabolism and health. Plasma pyridoxal phosphate (PLP) >30 nmol/L often has been considered     to be the cutoff indicative of nutritional adequacy, with 20-30 nmol/L considered marginal     deficiency; however, the current Recommended Dietary Allowance (RDA) value was based on a     more conservative cutoff of 20 nmol/L plasma PLP. As shown by in the investigators     preliminary data, biochemical perturbations occur when humans have marginal B6 deficiency     consistent with plasma PLP of 20-30 nmol/L. A prospective study also showed that plasma PLP     <23.3 nmol/L is associated with 1.8-times higher risk of recurrent venous thromboembolism     than those with PLP >23.3 nmol/L. The mechanism by which low B6 intake is associated with     risk of vascular disease is not known. Since B6-deficiency has little tendency to raise     fasting plasma total homocysteine (tHcy) but yields an elevated tHcy response following a     methionine load, low B6 nutriture may lead to repeated transient mild hyperhomocysteinemia     following meal consumption. Several reports of associations between elevated plasma     C-reactive protein (CRP) and low B6 status have raised the hypothesis that systemic     inflammation is prone to occur during B6 deficiency or contributes to low B6 status. The     investigators previously found that healthy humans in low B6 status caused by dietary     restriction exhibited normal plasma CRP levels. The investigators also postulate that     oxidative stress associated with low B6 status, coupled with impaired glutathione synthesis,     contributes to such risk. These questions indicate the need for a more thorough understanding     of the metabolic changes occurring in low B6 status from marginal B6 intake and from drug     interactions such as in women using oral contraceptives.   "
249842|NCT01128257|"     This observational study will assess the compliance and persistence of patients, real life     efficacy and safety of intravenously quarterly administered 3 mg ibandronate [Bonviva/Boniva]     in comparison to oral alendronate generics in female patients with post-menopausal     osteoporosis. The anticipated time of assessment is 12 months. The target sample size is     5000-7000 patients.   "
249843|NCT01128270|"     This is a research study to look at how Dichloroacetate (DCA), and investigational drug and     chloral hydrate are broken down in the body. The purpose of the study is to better understand     how humans metabolize these two common chemicals that are widely present in the environment.     The study focuses on how the drug chloral hydrate is broken down and how it effects DCA   "
249844|NCT01128283|"     We will collect blood samples from patients with the diagnosis of sepsis and other ICU     patients. We will describe the course of different mediator levels and organ injury markers     and follow their progression throughout the course of the study.   "
249845|NCT01128296|"     The primary goal of the research study is to determine whether treating pancreatic cancer     patients with hydroxychloroquine in combination with gemcitabine before surgery is safe. The     secondary goal is to determine if this new treatment regimen can effectively treat pancreatic     cancer. This study will test the safety and efficacy of this combination in two parts, or     phases.   "
249846|NCT01128309|"     The aim of the study is to test whether Generalized Anxiety Disorder (GAD) patients that     participate in a Stress Reduction Intervention show a brain activation pattern (assessed by     MRI) indicative of improved emotion regulation compared to an active control intervention.   "
249847|NCT01128322|"     The aim of this trial is to determine the best dose combination of S-Amlodipine and     Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a     once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their     monotherapy components and placebo, in patients with stage I or II essential hypertension(a     mean seated cuff diastolic blood pressure >=95 and <=115 mmHg).   "
249849|NCT01128348|"     Half of US adults have no more than basic reading and numerical skills. A consequence is     inadequate health literacy, which is associated with unsatisfactory patient-provider     communication and poor health outcomes in chronic diseases, including asthma. We have adapted     a patient navigator intervention to address asthma in high risk communities as a practical,     immediate, and sustainable method of achieving effective health literacy in patients low     health literacy. This intervention will lead to improved adherence and asthma control,     attenuating health disparities so marked in asthma. It is compared for efficacy and     cost-effectiveness with asthma education.   "
249850|NCT01128361|"     The current project is a natural extension of a programmatic line of investigation into the     relationship between exercise, brain aging, and AD that Dr. Burns has developed over the last     four years. The current study will provide data to estimate expected effect sizes for power     analyses and sample size calculations. It will also provide an opportunity to optimally     design a larger trial that can be extended to multiple sites to more definitively examine the     role of exercise as a therapy in AD. The current project's aims are an important and     necessary developmental step given the lack of fitness data in AD and the limited knowledge     of the mechanisms that may form the basis of an association between aerobic fitness and AD.   "
249851|NCT01128374|"     Type 2 diabetes mellitus (T2DM) has become a significant pandemic with more than 7% of the     population in the United States affected. Moreover, up to one-third of these individuals may     not be aware of the diagnosis and, are not involved in treatment. In the Mexican-American     population, prevalence rates may be up to 50%. Contributing factors such as poor education,     low household income, language barriers and restricted access to medical services may     increase this prevalence. The association between periodontal disease and diabetes has been     well documented; however, interventional studies have resulted in conflicting conclusions on     improvements in glycemic control following periodontal therapy.      Diabetes and periodontal disease share common pathways in pathogenesis, such as their     polygenic nature and immunoregulatory dysfunction. To answer these questions, we, the     investigators, propose this randomized controlled trial designed to elucidate how treatment     of periodontal disease can be used for preventive and therapeutic purposes in a diabetic     population as well as to study the role of IL-1 gene cluster polymorphisms as a risk factor     for the presence of periodontitis in a Hispanic T2DM population. Our central hypothesis is     that the Mexican-American T2DM population in Texas is at risk for an increased presence and     severity of periodontal disease due to the presence of Il-1 gene cluster polymorphisms;     furthermore we suggest that providing non-surgical periodontal therapy to this group will     decrease the bacterial load associated with disease and as a consequence, will improve     glycemic control as measured by HbA1c values. Our long-term goal is to study risk factors     associated with the presence of periodontal disease and to understand how the treatment of     periodontal disease can be used for preventive and therapeutic purposes in a Hispanic type 2     diabetic population.   "
249852|NCT01128387|"     The overall study objective is to evaluate the dose limiting toxicities and the recommended     phase II dose of Panitumumab when combined with the standard of care treatment with     cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer.     The investigators will also be assessing the ability of PET imaging to predict the degree of     pathologic response.      All patients will have a pre-study FDG PET scan and will receive radiation therapy and     chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be     restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will     undergo an esophagectomy which is considered standard of care post radiation and     chemotherapy. The surgery will allow us to compare this study regimen to the historical     standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).   "
249853|NCT01128400|"     There are many substances naturally present in the mouth that may help us taste fat in food.     Two of these substances (lipases and CD36) will be examined in this study.      The presence of fat in food increases food tastiness, therefore people often over-eat     high-fat foods and gain weight. The purpose of this study is to determine if blocking lipases     and some genetic variations in the CD36 gene will make fatty food less tasty so that people     eat less. Our hypothesis is that Orlistat and a particular gene will increase one's ability     to detect fat.   "
249854|NCT01128413|"     The short term goal of this study is to evaluate a non-invasive approach that optimizes     intravenous (IV) fluid administration according to heart performance and results in surrogate     improvements in morbidity and mortality via lactate clearance. Additional objectives include     comparative assessments of methods for determining volume responsiveness and establishing a     prevalence of volume responsive shock in the Emergency Department (ED).   "
249855|NCT01128426|"     The purpose of the study is to expand the understanding of the safety profile of 13vPnC in     routine use following licensure and introduction of the vaccine.   "
249856|NCT01128439|"     This study will estimate the incidence of invasive pneumococcal disease in members of the     Northern Kaiser Permanente healthcare system during each of the 5 following introduction of     Prevnar 13.   "
249857|NCT01128452|"     This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled     monotherapy study in patients with treatment-resistant major depression. After confirmation     of treatment-resistance in a prospective treatment period with citalopram, each patient will     be treated with either EVT 101 once daily or placebo for 28 consecutive days.   "
249858|NCT01128465|"     Certain kind of neurosurgical procedures require intraoperative alertness of the patient, for     example to perform speech tests during brain tumor resection. With respect to anaesthesia, it     is therefore required that the patient is asleep during the beginning and the end of the     procedure, however fully awake in between. To do so, the anaesthetic propofol is used and an     accurate knowledge of its pharmacokinetic and -dynamic (pk/pd) parameters is required to     optimally control anaesthesia. However, diverse pk/pd-parameter sets have been described in     the literature.      The aim of the study is to investigate whether the pk/pd model proposed by Marsh et al. or by     Schnider et al. more accurately describe the pk/pd of propofol during awake craniotomy.   "
249859|NCT01128478|"     Pain relapse during oral refeeding occurs in at least one-fifth of patients with acute     pancreatitis. The study hypothesis is that early administered enteral tube feeding might     reduce a risk of pain relapse and shorten the length of hospital stay in patients with acute     pancreatitis.   "
249876|NCT01128725|"     Beta amyloid immunoreactivity is probably due to a significant number of Ab catabolites     corresponding to N-terminally truncated and Cterminally truncated or extended forms which     display distinct propensity to aggregation. Very few things are known concerning the     mechanisms and proteases by which they are generated. Furthermore, the link between     truncation and toxicity has not been delineated.      Finally, little is known concerning Ab fragments in biological fluids and whether they could     be seen as early biomarkers and thereby, as putative targets for AD diagnostic. The present     project will allow to examine the human biological samples and to identify various cohorts     after complete clinical evaluation.   "
249860|NCT01128517|"     Overall Objective      • To evaluate impact of maternal educational strategies (teaching sessions by trained lady     health workers, verbal, pictorial and demonstrative) regarding appropriate complementary     foods of infants, and assess their impact on nutritional status of after six months of     educational intervention.      Specific objective • To determine the impact of maternal educational strategies regarding     complementary foods by assessing baseline weight, height and mid - upper arm circumference at     2.5 - 5 month of age and then comparing it at 3, 6 and 9 months after enrollment.      (Hypothesis; the investigators hypothesize that there will be a gain of 250 gram weight, 0.5     cm in length and 0.5 cm in MUAC in infants whose mothers received the special education     module for complementary feeding, as compare to the children whose mothers doesn't receive     education on complementary food.      Secondary objective      • To determine the impact of maternal educational strategies regarding complementary foods by     assessing morbidity (number of diarrhea and ARI episodes, at 2.5 - 5 month of age and at then     reporting at 3, 6 and 9 months after enrollment).      (Hypothesis; the investigators hypothesize that there will be 10% decrease in incidence of     diarrhea episodes and ARI episodes in infants whose mother received the special education     module for complementary feeding, as compare to the children whose mothers doesn't receive     education on complementary food).      ARI can be define as per IMCI guidelines. Increase breathing rate (age specific) along with     cough, cold and or wheezing.   "
249861|NCT01128530|"     The purpose of this study is to determine the clinical efficacy, safety, and tolerability of     a 250 mg BID oral dose of JNJ-32729463 compared with linezolid in subjects with complicated     skin and skin structure infections (cSSSIs).   "
249862|NCT01128543|"     This is a Multicenter, Open-Label, Phase II Study of lapatinib in Combination with     Vinorelbine in women with documented evidence of HER2/neu positive breast cancer which is     metastatic or recurrent and with or without prior chemotherapy or anti-HER2/neu targeted     therapy in the metastatic and relaps setting.   "
249863|NCT01128556|"     To evaluate the effect of BEPREVE compared to a REFRESH Tears Lubricant eye drop on the     measurement of the wheal and flare from histamine skin prick testing. This is an open label,     two-week, post-marketing study conducted on histamine responsive patients.   "
249864|NCT01128569|"     We propose to use an inhaled allergen challenge model to explore the individual contributions     of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS)     combination product on protection from allergic triggers in asthma.   "
249865|NCT01128582|"     To determine if administration of Rozerem in comparison to a placebo reduces or eliminates     gastroesophageal reflux disease(GERD) symptoms in individuals with both GERD and chronic     insomnia.   "
249866|NCT01128595|"     We propose to use an inhaled allergen challenge model to explore the individual contributions     of the components of a novel long-acting beta agonist/ inhaled corticosteroid combination     product and its components on protection from allergic triggers in asthma   "
249867|NCT01128608|"     To determine the effect of intraesophageal high PCO2 solution as compared to acidic and     saline solutions on subjects' heartburn sensation using stiumlus-response functions.   "
249868|NCT01128621|"     A study in type 2 diabetic subjects on stable metformin therapy to investigate the safety,     tolerability, pharmacokinetics and pharmacodynamics of co-administering single and multiple     oral doses of GSK1292263   "
249869|NCT01128634|"     The purpose of this study is to see if the Pharmacokinetics and the Safety Profile of     GSK573719 and GSK573719/GW642444 are effected by concurrent dosing with the PGP inhibitor     verapamil.   "
249870|NCT01128647|"     There is evidence that total carbohydrate oxidation during exercise is higher after ingestion     of fructose:glucose mixture than after ingestion of equimolar amounts of glucose alone. This     may possible contribute to improve performance, provided that the extra carbohydrate     oxidation induced by fructose:glucose co-ingestion occurs in skeletal muscle. The present     study aims at assessing the hypothesis that, during exercise, a substantial portion of oral     fructose is converted into lactate prior to oxidation To identify the major pathways of     fructose disposal, 7 healthy endurance trained male volunteers will be studied. For each     participant the following measurement will be performed        -  a measurement of maximal oxygen consumption (VO2 max) on an ergometric bicycle        -  a 2 hour exercise protocol with oral administration of a glucose drink. 6,6-2H2 glucose          (0.44 µmol/kg/min) and 13C3 lactate (2.25 µmol/kg/min) will be infused to calculate          glucose and lactate kinetics. Indirect calorimetry will be performed to measure total          carbohydrate oxidation and expired 13CO2 will be monitored to calculate whole body          lactate oxidation        -  a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g          every hour) mixture. 6,6-2H2 glucose (0.44 µmol/kg/min) and 13C3 lactate (2.25          µmol/kg/min) will be infused to calculate glucose and lactate kinetics. Indirect          calorimetry will be performed to measure total carbohydrate oxidation and expired 13CO2          will be monitored to calculate whole body lactate oxidation        -  a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g          every hour) mixture with fructose labelled with 13C6 fructose to evaluate exogenous          fructose metabolic fate and oxidation. 6,6-2H2 glucose (0.44 µmol/kg/min) will be          infused to calculate glucose kinetics. Fructose conversion into lactate and glucose will          be evaluated by monitoring the systemic appearance of plasma 13C-labelled lactate and          13C-labelled glucose. Total exogenous fructose oxidation will be measured by monitoring          13CO2 production.      Based on these measurements, semi-quantitative estimates of total fructose oxidation,     fructose conversion into glucose, fructose conversion into lactate, and oxidation of     fructose-derived lactate will be obtained   "
249871|NCT01128660|"     The purpose of this study is to twofold. The investigators wish to introduce a new     patient-descriptive parameter, the 'Fidelity Coefficient', and use it to assess and compare     the overview of patient's medication possessed by the general practitioners and the     pharmacies.   "
249872|NCT01128673|"     Hundreds of babies in the world are being treated with brain cooling to prevent brain injury     after they lose oxygen at birth. This study will use the newly developed information from the     magnet resonance image to determine the actual temperature of the brain. This will enable us     to determine if the brain is being uniformly cooled and if techniques that provide cooling     need to be changed to improve the injury prevention from cooling.   "
249873|NCT01128686|"     This is to evaluate the proportion of subjects who show good responses to LAM treatment in     Korea.   "
249874|NCT01128699|"     The investigators aim to demonstrate the efficacy and safety of subconjunctival injection of     Avastin as an adjunctive therapy for Ahmed valve glaucoma implant in patients with refractory     glaucoma.   "
249875|NCT01128712|"     To prospectively demonstrate the superior anxiolytic effect of high dose pregabalin (PGB)     therapy (450 mg/day) compared to low dose PGB therapy (150 mg/day) in subjects with medically     refractory partial epilepsy not fully controlled despite treatment with 1-2 concomitant     antiepileptic drugs (AEDs).   "
249877|NCT01128738|"     The primary objective of this study is to demonstrate superiority of single treatment of     GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of     treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal     injections based on gravimetric assessment (measurement of spontaneous axillary sweat     production) for axillary hyperhidrosis.   "
249878|NCT01128751|"     In a randomized controlled trial patients undergoing aortic valve replacement are recruited     into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce     solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT),     designed to reduce gaseous microemboli from cardiopulmonary bypass (CPB), or no additional     device (control-group). Cognitive functioning is assessed 3 weeks to 1 day before and 3     months (+/- 1 week) after valve replacement. Furthermore, cerebral magnetic resonance imaging     (MRI) is carried 2-6 days after surgery. Primary endpoint is the cognitive outcome of the     filter groups compared to the controls. Secondary endpoint is the number of acute ischemic     lesions after CABG.   "
249879|NCT01128764|"     Lifetime prevalence of major depression is estimated at 28% by age 18 (Lewinsohn et al.,     1999), with higher cumulative rates in females (35%) than males (19%). Approximately 17% of     children and adolescents in the United States are obese as defined by a BMI above the 95th     percentile, with more than 30% falling between the 85th and 95th percentiles (Ogden et al.,     2008). Overweight children and adolescents are at increased risk for type 2 diabetes     (Pinhas-Hamiel et al., 1996) and overwhelming risk for adult obesity (Guo et al., 1994).     There is a substantial percentage of adolescents who are both overweight and depressed with     estimates from clinical samples averaging 25%. Treatment of teens with comorbid medical and     psychiatric conditions such as overweight/obesity and depression has received little to no     attention in the psychosocial treatment research literature. Due to the large number of     adolescents who are both depressed and overweight, developing a behavioral treatment that     addresses both problems simultaneously has important public health significance. The purpose     of this proposal is to combine treatments for depression and overweight to address these     co-occurring conditions in one intervention. The long-term objectives of this research are to     develop efficient and effective treatments for co-occurring physical and emotional disorders.     The research program will be divided into 3 major phases: a development phase (Stage 1a), a     pilot study phase (Stage 1b), and a revision phase. During the development phase (Stage 1a),     a treatment for overweight teens and CBT treatment for depressed teens will be adapted into     one integrated protocol that addresses depression using CBT techniques, an exercise     component, and advice regarding healthy eating. As part of this phase, we will adapt existing     intervention manuals and therapist training materials, and gain some initial clinical     experience with the intervention via an open trial with 6 teens. During the randomized pilot     study phase (Stage 1b), the integrated intervention will be compared to a control group     receiving CBT treatment for depression alone (N=40 in total). During the pilot phase, the     feasibility and acceptability of administering the program will be assessed. In addition, we     will compare change in depressed mood at end of treatment and 6 month follow-up periods     across the two groups. During the revision phase, the intervention manual will be further     developed and refined, based on experiences and observations made during the development and     pilot study phases.   "
249880|NCT01128777|"     The total number of military personnel is over 3.5 million and approximately 43% have     children. The deployment cycle can be associated with depression, anxiety, and behavior     problems in children as well as psychological distress in the military spouse. Further, the     health of family members can affect the physical and psychological functioning of the     military service member during the deployment and re-integration periods. While research and     federal funding has been dedicated toward developing treatments for the returning service     member, intervention protocols for mental health problems in the children of military     families have not been tested. In collaboration with the Family Readiness Program of the     Rhode Island National Guard & Reserves, the purpose of this proposal is to develop a     cognitive behavioral treatment protocol for adolescents experiencing depression, anxiety,     and/or behavior problems associated with the deployment and re-integration phases of the     military deployment cycle. This protocol will be created by modifying an NIH funded cognitive     behavioral protocol for the treatment of adolescent mental health problems with initial     demonstrated efficacy (PI, C. Esposito-Smythers). There are three primary aims in this     project: 1) develop the manualized intervention protocol for adolescents experiencing mental     health problems associated with the deployment cycle; 2) refine and pilot the intervention     protocol with 12 families; and 3) test the intervention in a randomized pilot trial. To     accomplish these aims, a two step sequence of treatment development is proposed. Stage Ia     includes initial manual development, focus groups, therapist training, and an open pilot     trial. Stage Ib includes a randomized pilot trial. Seventy-two adolescents and their     caretakers will be enrolled through the Rhode Island Family Readiness program and randomly     assigned to the experimental intervention or non-directive supportive therapy for their     outpatient care. The experimental intervention includes 12 adolescent group sessions which     address depression, anxiety, and behavior problems associated with the deployment cycle and     12 parent group sessions that address stress management and parenting skills. The     non-directive supportive therapy condition includes 12 adolescent and 12 parent group     sessions which involve patient initiated discussions focused on issues surrounding military     deployment and re-integration. Outcome will be assessed at post-treatment and 3 month     follow-up. The long term objective of this research is to yield an effective outpatient     intervention for teens of military service members experiencing mental health problems     associated with the deployment and re-integration phases of the deployment cycle.   "
249881|NCT01128790|"     The purpose of this study is to determine the effect of remote ischemic preconditioning on     exercise capacity in patients with heart failure.   "
249882|NCT01128803|"     The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of     hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after     treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The     aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an     approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous     dendritic cells loaded with specific peptides of AFP.   "
249883|NCT01128816|"     Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the     heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is     associated with increased risk of hospitalizations and death. It is not known however whether     treating SA reduces these risks. This study is looking at whether a respiratory device known     as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations     and death in subjects with HF and SA. Study subjects will randomly receive either their     regular medications OR their regular medications plus ASV. They will be followed for     approximately 5 years and information relevant to their health will be collected and     compared.   "
249884|NCT01128829|"     Several sugar-replacement sweeteners are currently on the market, including saccharine (ex.     Sweet'N Low), aspartame (ex. Equal), and sucralose (ex. Splenda). The purpose of this study     is to examine wether non caloric sweeteners affects how well the body works to control blood     sugar. The study includes detailed blood sugar testing after drinking liquids that may     contain sucralose. The investigators hypothesize that drinking liquids with sucralose will     effect the amounts of specific appetite-affecting substances naturally produced by the body.   "
249885|NCT01128842|"     This is an open-label, phase 1 study of ascending single cohort of neratinib (HKI-272)     combination with capecitabine.   "
249886|NCT01128855|"     The purpose of this study is investigate the pharmacokinetics, safety and tolerability of     single subcutaneous administration of GSK2402968 in non-ambulant boys with Duchenne muscular     dystrophy   "
249887|NCT01128868|"     The purpose of this study is to compare the abductor muscle strength measured with a     dynamometer in patients with reverse oblique inter- or subtrochanteric fractures treated     either with a proximal femur locking plate or a trochanteric nail.      Proximal femur locking plates stands for both the PF-LCP (Synthes) and the PeriLoc (Smith &     Nephew). Trochanteric nails allowed in this study are the Proximal Femoral Nail Antirotation     (PFNA), the Titanium Trochanteric Fixation Nail (TFN) and the Gamma Nail (GN).   "
249913|NCT01129206|"     RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving pralatrexate together with docetaxel may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving pralatrexate together with docetaxel     works in treating patients with stage IV esophageal or gastroesophageal cancer who have     failed platinum-based therapy.   "
249888|NCT01128881|"     The primary objective of this study is to prospectively document the exposure to IMMUNINE and     to monitor FIX inhibitors over a period of approximately 20 to 50 exposure days while     receiving prophylactic treatment in up to 50 previously treated patients (PTPs) aged 12-64     years and approximately 20 pediatric PTPs up to 11 years of age with severe (FIX level < 1%)     or moderately severe (FIX level <= 2%) hemophilia B who are planned to enter BAX326 study     250901, provided all eligibility criteria are met.      In addition, this study will evaluate the efficacy, safety, immunogenicity, thrombogenicity,     and health-related quality of life (HR QoL) of these subjects.   "
249889|NCT01128894|"     This open-label study examines the efficacy and safety of albiglutide as compared with     liraglutide in subjects with type 2 diabetes.   "
249890|NCT01128907|"     Invasive Aspergillosis (IA) is a very serious fungal infection. Hematological patients are     the most affected group. IA has a very high morbimortality due to its rapid progression and     because it is very difficult to be early diagnosed. Diagnosis is used to be done too late or     even post-mortem. They are two new methods (techniques) trying to make the diagnosis on an     early stage: detection of Galactomannan antigen of Aspergillus species and real - time     polymerase chain reaction (PCR) of its DNA in blood. IA in immunocompromised patients is     mainly located in lungs, so our hypothesis is that in patients where the investigators     suspect IA the investigators should find earlier Galactomannan antigen or real -time PCR of     Aspergillus in respiratory samples such as bronchoalveolar lavage (BAL), and its detection     could be useful for diagnosis.      Objectives: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in     bronchoalveolar lavage. To validate the routine utility of these tests in BAL as a diagnostic     method of IA and investigate if Galactomannan Antigen and Real Time - PCR for Aspergillus DNA     in bronchoalveolar lavage can optimize blood test sensibility.      Methods: Prospective study. The investigators will include 200 patients. 100 of them will be     hematological patients, neutropenic and at high risk to develop an IA. The other 100 will be     patients without risk or no suspicion at all of IA. The investigators will perform a BAL in     all patients. And blood detection of Galactomannan Antigen in hematological patients. The     investigators will perform a standard microbiological culture of BAL and Galactomannan     Antigen in both samples (bronchoalveolar lavage and blood). The investigators also will carry     out Real Time - PCR for Aspergillus DNA detection in bronchoalveolar lavage.      Expected results: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in     BAL with more specificity and making earlier diagnosis than in blood. The investigators also     expect to implant these techniques in BAL in the routine for IA diagnosis in neutropenic     patients.   "
249891|NCT01128920|"     The purpose of this study is to develop and test an intervention to reduce bacterial and     viral infections among injection drug users.   "
249892|NCT01128933|"     The purpose of the study is to determine potential utility of renal fractional flow reserve     in prognosis predicting after renal stent implantation.   "
249893|NCT01128946|"     This study will use an oral in-situ caries model to study remineralization of enamel due to     the action of different combinations of fluoride salts delivered from dentifrices.   "
249894|NCT01128959|"     The purpose of this study is to assess the safety and tolerability of intravenous (IV)     carbamazepine (CBZ) administered as multiple 15 minute infusions and a single 5 minute     infusion to adult patients with epilepsy on stable higher doses of oral CBZ.   "
249895|NCT01128972|"     An in situ model will be used to evaluate and compare enamel remineralization of bovine     enamel specimens.   "
249896|NCT01128985|"     The purpose of this study is to evaluate the pharmacokinetics (blood levels of the drug) and     pharmacodynamics (effects of the drug on the body) of canagliflozin after oral administration     to patients with type 2 diabetes mellitus.   "
249897|NCT01128998|"     Primary Objective:        1. To define the recommended dose for phase II study of S-1 combined with sorafenib        2. To evaluate the dose-limiting toxicities of the combination therapy      Secondary Objectives:        1. To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination          therapy        2. To investigate the impact of genetic polymorphisms of metabolic genes on the PK of          sorafenib and S-1, respectively, as well as on the toxicity profile of the combination.        3. To determine the changes of biomarkers between pre- and post-treatments.   "
249898|NCT01129011|"     This study uses a randomized, double-blind, controlled design to demonstrate that PN400     (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal     ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric     ulcers compared to naproxen alone.   "
249899|NCT01129024|"     This is a Phase 2, multicenter, open-label, dose-ranging, parallel-group extension study to     evaluate the safety of S-888711 in the treatment of subjects with immune thrombocytopenia.     Patients who participate in this study must have completed the Phase 2 double-blind,     randomized controlled study.   "
249900|NCT01129037|"     Wide excision of head and neck cancer with microsurgical free flap's reconstruction (FFR)     results to a high cancer cure rate and a good functional recovery. However, this long complex     procedure is accompanied with considerable complications. Excessive fluid administration     during this type of surgery has been connected with poor results. There is growing evidence     that goal-directed fluid management (GDFM) might improve the results in high-risk patients.      Hypothesis: Goal directed fluid management will reduce intraoperative fluid volume     administered to patients undergoing head and neck reconstructive surgery.   "
249901|NCT01129050|"     The major purpose of this study is to examine the effect of two sources of dietary omega-3     fatty acids, each given at two doses, on potential health benefits related to cardiovascular     disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and     flaxseed oil.   "
249902|NCT01129063|"     The objectives of the study are to:        -  Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel          and its active metabolite after a replicated single administration of 75 mg of          clopidogrel in healthy male and female subjects        -  Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after          single administration of 75 or 300 mg of clopidogrel   "
249914|NCT01129219|"     This is a randomized, controlled; single-blind parallel group trial carried out with hip     fracture patients, starting at 12 weeks post fracture. Patients were approached during their     acute stay in hospital, followed without any extra intervention for 12 weeks, and then     randomized in a 2:1 manner to either intervention or control for the next 12 weeks. After the     first 12 weeks intervention the intervention group were divided into two groups and     randomized to an new single-blind parallel group trial for further intervention.   "
249915|NCT01129232|"     The purposes of this study are to test whether GAD vaccination can stop the progression of     newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis)     in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and     finally try to detect viruses and virus receptors directly in the insulin producing beta     cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (T1D).   "
249916|NCT01129245|"     The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and     non-steroidal anti-inflammatory drug) has on ovulation.   "
249903|NCT01129076|"     Background:        -  Thalassemia major (TM) is a chronic disorder that affects a person s ability to produce          hemoglobin, resulting in anemia. Hemoglobin is a component of red blood cells that          carries oxygen and nutrients to cells in the body. As a result, individuals require          life-long blood transfusions and extensive medical management. Studies have shown that          because of its demanding nature, TM might negatively affect an individual s quality of          life, sense of self, and social integration, but little is known about affected          individuals overall experiences with and perceptions of TM.        -  TM is caused by a genetic change in the thalassemia gene. The disease is passed to          children by parents who carry one copy of the altered thalassemia gene. The parents are          called carriers of the condition and have a 25 percent chance of having a child with TM.          It is possible to screen for carriers of TM and use this information for pregnancy          planning and management.        -  TM is common among people from South and South East Asia and is an important public          health concern in Singapore. More research is needed to explore the lives of people with          TM, and the societal perceptions that exist in Singapore about TM.      Objectives:        -  To describe the familial, social, and professional experiences of individuals with TM.        -  To investigate the social messages being given out about TM in Singapore and the sources          of those messages.        -  To explore the impact of these experiences, perceptions, and social messages on          individuals who have TM.        -  To explore how the experiences and perceptions of individuals who have TM affect their          life, sense of self, social integration, and compliance with medical treatment.      Eligibility:        -  Residents of Singapore who are 14 years of age or older, can speak English, and          currently have TM.        -  Parents of individuals with TM who are 14 years of age or older. Parents must be 21          years of age or older, be able to speak English, and have had caregiving          responsibilities for their child at some point.      Design:        -  All participants will have a one-time semi-structured interview, followed by a          questionnaire to obtain demographic information.        -  Interviews will be conducted in Singapore and are expected to last for 30 to 90 minutes.        -  Individuals with TM will be asked about their own perceptions of TM; familial, social,          and professional experiences involving TM; and their perceptions of others views and of          social messages related to TM.        -  Parents of individuals with TM will be asked about their experiences in caring for a          child with TM, talking to their child about TM, telling people about their child s TM,          and interacting with health care providers.   "
249904|NCT01129089|"     The study aims to confirm the acceptability of lipid-based nutrient supplements (LNS) for use     as nutritional supplements for pregnant and lactating women (PLW) or infants and young     children (IYC) and micronutrient powder (MNP) for use as nutritional supplements for infants     and young children in Bangladesh.We hypothesized that at least 75 percent of the test dose of     LNS and MNP offered to PLW and IYC will be consumed by them.   "
249905|NCT01129102|"     The purpose of this study is to determine whether NPC-01 is effective in the treatment of     dysmenorrhea.   "
249906|NCT01129115|"     This is a randomized, 26-week study of supervised exercise assessing three doses of exercise     in sedentary individuals 65 years of age and over with age-related cognitive changes. A total     of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic control     group, 75 minutes, 150 minutes, or 225 minutes a week of moderate intensity aerobic exercise     spread over 3 to 5 days a week for 26 weeks. These exercise doses represent 50%, 100%, or     150% of the recommended exercise dose. Participants will be directly supervised during all     exercise sessions for the first two months after which direct supervision will occur during     at least one session a week. This is intended to provide increased flexibility while also     maintaining direct contact with the participant to enhance adherence. Aerobic fitness,     physical function, and cognition will be assessed at baseline and 26 weeks to examine the     dose-response relationships.   "
249907|NCT01129128|"     The goal of this study is to determine if either of two, commercially available, Echinacea     purpurea products stimulate the immune system. For the study, 60 healthy adults will be     randomized to receive one of the two Echinacea purpurea products or placebo for 10 days.     Blood will be drawn to assess immune markers just before beginning the study medication,     during the 10 day course of medication and after completing the course of medication. It is     postulated that adults receiving either of the Echinacea products will have evidence of     immune stimulation and those receiving placebo will not.   "
249908|NCT01129141|"     This study continues the investigators' efforts to develop tinnitus management protocols for     Veterans. More specifically, this study developed and evaluated an adaptation of Progressive     Tinnitus Management (PTM) for use as a telephone-based program for Veterans and military     personnel who have experienced TBI. This adaptation, called Tele-PTM, is a telephone-based     program and has the potential of providing needed tinnitus services to Veterans with and     without TBI for a relatively small cost and with minimal impact on individual VA hospitals.   "
249909|NCT01129154|"     Squamous Cell Carcinoma (SCC) is one of the most common malignancies in caucasian population.     The effect of the immune system on the development of skin tumors has been demonstrated in     transplant patients taking immunosuppressive agents (65 fold risk increase). It has been     reported that activation of EGFR and RAS signaling pathways play an important role in disease     progression maybe through downregulation of the immune system.      The investigators want to treat unresectable SCC patients with an antibody against EGFR     (Vectibix®, panitumumab). This antibody induces tumor regression in metastatic colorectal     cancer and has been approved as single agent for this indication.      The investigators want to measure the response rate but also analyze the modification of     expression profile of some key proteins involved or supposed to be involved in the signaling     pathways of EGFR and in the regulation of the immune system. Chemokines such as CCL27 have     been shown to play a critical role in the skin-associated immune response by regulating T     cell homing. Pivarcsi et al have reported that downregulation of CCL27 is mediated by     activation of EGFR/RAS/MAPK signaling pathways.   "
249910|NCT01129167|"     Pancreatic cancer often spreads through local invasion into local structures, including fat,     blood vessels, nerves, and nearby organs (stomach, duodenum, spleen, bile duct). Local     microscopic invasion is associated with recurrence of pancreatic cancer after pancreatic     resection, such that even if the original cancer is surgically removed, microscopic areas of     cancer often remain. Data on the patterns of local invasion by pancreatic cancer have not     been published. In this study, The investigators hope to investigate the frequency of the     various methods of local invasion of pancreatic adenocarcinoma. This would help the     investigators better understand how pancreatic cancer spreads, and determine what cancers are     not resectable.   "
249911|NCT01129180|"     RATIONALE: Bortezomib and azacitidine may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     given together with azacitidine in treating patients with relapsed or refractory T-cell     lymphoma.   "
249912|NCT01129193|"     RATIONALE: AR-42 may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of AR-42 in treating     patients with advanced or relapsed multiple myeloma, chronic lymphocytic leukemia, or     lymphoma.   "
249917|NCT01129258|"     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK),     and pharmacodynamics (PD) of PF-04991532 following multiple (14 days) escalating oral doses     in patient wtih type 2 diabetes.   "
249918|NCT01129271|"     Primary objective:        -  Investigate the potential food effect on Adenosine diphosphate(ADP)-induced platelet          aggregation after 5-day repeated doses of clopidogrel (300 mg loading dose followed by 4          days 75 mg/day) in healthy subjects      Secondary objectives are to investigate the potential food effect on:        -  ADP-induced platelet aggregation after 300 mg loading dose of clopidogrel        -  Pharmacokinetic profiles of clopidogrel and its active metabolite after 5-day repeated          doses of clopidogrel   "
249919|NCT01129284|"     This study will examine the safety and effectiveness of ACTHAR Gel, when used to treat 15     patients diagnosed with treatment resistant nephrotic syndrome.      Nephrotic syndrome is a group of symptoms that includes low levels of protein in the blood,     swelling of tissue (edema), especially around the eyes, feet and hands; and high plasma     levels of cholesterol. It is caused by a variety of diseases and underlying disorders that     damage the kidneys, resulting in excessive excretion of protein in the urine. These diseases     damage the glomeruli, which are small blood vessels that filter wastes and excess water from     the blood and pass them into the bladder as urine. As a result of protein loss in the urine,     the blood is deficient in protein. Normal amounts of blood protein are needed to help     regulate fluid throughout the body. Protein in the blood normally draws water from the     tissues and into the bloodstream. When blood protein levels are low, the normal movement of     water is reversed, and fluid is drawn from the blood and accumulates in the tissues. This     excess tissue fluid causes the swelling and puffiness (edema) that is a symptom of nephrotic     syndrome.      Nephrotic syndrome is described as treatment resistant when a patient fails to achieve a     sustained partial or complete remission after treatment with at least two first line     therapies.      The goal of this study is to determine whether injections of ACTHAR Gel (an FDA approved     treatment for nephrotic syndrome) over a six month period will lead to a correction of     treatment resistant nephrotic syndrome in these patients.   "
249920|NCT01129297|"     Type 2 diabetes and obesity are both multifactorial diseases resulting from gene-environment     interactions. However, this interaction, as well as the specific effect of each polymorphism,     remains poorly understood.      We now proposed a prospective cohort study to improve our understanding of the influence of     phenotypic characteristics on gene expression in tissues involved in glucose and/or lipid     metabolism by collecting different biological samples.   "
249921|NCT01129310|"     The investigators hypothesize IXO chemotherapy will have an improvement in response rate and     acceptable toxicity for uncurable metastatic gastric cancer compared to historical controls.   "
249922|NCT01129323|"     The purpose of this study is to evaluate the effectiveness of allogeneic transplant after a     reduced-intensity preparative regimen for patient, to evaluate survival, and to evaluate the     side effects of this treatment. The patient will be in the study for two years for treatment     and active monitoring. After treatment and active monitoring are over, the patient's medical     condition will be followed indefinitely.   "
249923|NCT01129336|"     This study will evaluate zoledronic acid's anti-cancer effects and Circulating Tumor Cell     (CTCs) measurements in patients with HER2-negative metastatic breast cancer without bone     metastasis.   "
249924|NCT01129349|"     To evaluate the safety and tolerability of Oprozomib in patients with advanced refractory or     recurrent solid tumors including determination of its Dose Limiting Toxicity (DLT) and     Maximum Tolerated Dose (MTD) To determine the pharmacokinetics (PK) of Oprozomib To explore     the anti-tumor activity of Oprozomib in this patient population including the overall     response rate (ORR), the duration of responses (DOR), the progression-free survival (PFS) and     time to progression (TTP) To define the pharmacodynamics (PDn) of Oprozomib.   "
249925|NCT01129362|"     The purpose of this cohort study is to determine vaccine-specific rates of pertussis disease     during the period of the study, among Wisconsin residents younger than 60 months of age (the     Surveillance Population), and to descriptively compare the proportion of such persons     vaccinated with Pentacel® vaccine who acquire pertussis disease to the proportion of such     persons vaccinated with any other Diphtheria and Tetanus Toxoids and Acellular Pertussis     (DTaP) vaccine who acquire pertussis disease.      Primary Objective:      To determine the rates and relative risk of pertussis disease among Surveillance Population     members who have received Pentacel vaccine or another pertussis vaccine.   "
249926|NCT01129375|"     Primary objective:        -  Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on          Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with          omeprazole 80 mg/day compared to given alone in healthy male and female subjects      Secondary Objective:        -  Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when          clopidogrel is given either alone or concomitantly with omeprazole   "
249927|NCT01129388|"     Primary objective:        -  Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on          Adenosine diphosphate (ADP)-induced platelet aggregation when given either alone in the          morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours          interval in healthy male and female subjects      Secondary Objectives:        -  Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when          clopidogrel is given either alone alone in the morning, or in association with          omeprazole in the evening at a 12-hours interval   "
249928|NCT01129401|"     This treatment outcome evaluation of the Stonewall Project will recruit 150 participants to     complete a face-to-face assessment visit at baseline, 3-month follow-up, and 6-month     follow-up to examine treatment outcome with respect to HIV risk and substance use.   "
249929|NCT01129414|"     Primary objective:        -  Assess the effects of clopidogrel (600 mg loading dose followed by 4 days 150 mg/day) on          Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with          omeprazole 80 mg/day compared to given alone in healthy male and female subjects      Secondary Objective:        -  Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when          clopidogrel is given either alone or concomitantly with omeprazole   "
250246|NCT01125449|"     The study is designed to determine if high doses of intravenous ascorbic acid (vitamin C) can     be effective in managing solid tumor diseases. Secondary goals are determination of any     palliative effects and improvement of quality of life of patients.   "
255157|NCT03269994|"     The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or     piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after     pancreatoduodenectomy.   "
249930|NCT01129427|"     Primary objective:        -  Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on          Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with          pantoprazole 80 mg/day compared to given alone in healthy male subjects        -  Compare the pharmacokinetic profiles of clopidogrel active metabolite when clopidogrel          is given either alone or concomitantly with pantoprazole      Secondary Objective:        -  Compare the pharmacokinetic profiles of clopidogrel when clopidogrel is given either          alone or concomitantly with pantoprazole   "
249931|NCT01129440|"     The goal of this project is to conduct a community-based randomized clinical trial to compare     the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride     varnish applied every six months and fluoride releasing glass ionomer sealants applied     annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.   "
249932|NCT01129453|"     The purpose of this study is to determine whether CVD 1902 (a live, attenuated, oral vaccine)     is safe and effective in the prevention of Salmonella enterica serovar paratyphi A infection.   "
249933|NCT01129466|"     Purpose: To compare the change in nasal cell HO-1 expression induced by two different     preparations of sulforaphane (SFN)-containing nutritional supplements Participants: Healthy     nonsmoking young adults, age 18-35 Procedures (methods): This pilot study will use a     randomized crossover design. Subjects will be randomized to receive either the equivalent of     4 ounces/day of fresh broccoli sprouts (FBS) in food and tea, or the equivalent amount as     broccoli sprout homogenates (BSH), for 3 consecutive days. Nasal lavage and blood samples     will be obtained before, during and after this 3-day period. After at least a 2-week washout     interval, the protocol will be repeated with the alternate supplement. The primary analysis     will test the hypothesis that broccoli sprouts in food will increase HO-1 expression to a     similar degree as the equivalent amount of sprouts in BSH   "
249934|NCT01121146|"     The purpose of the study is to determine whether crosslinked Marathon and standard Enduron     polyethylene liners show differences in bone loss around the hip implant.   "
249935|NCT01121159|"     Accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is     better with preoperatively preformed orbital implants than with non-preformed orbital     implants.   "
249936|NCT01121172|"     The aim of this study is to investigate serum apelin levels as well as their possible     association with G212A polymorphism of the apelin receptor in obese children and adolescents.      So far apelin has been reported to be involved in the pathophysiology of various heart     diseases such as cardiomyopathies and heart failure. According to recent reports in adults     apelin seems to be associated with impaired glucose metabolism, particularly in newly     diagnosed diabetes type 2 patients. Obesity is associated with insulin resistance and     compensatory hyperinsulinemia leading to diabetes mellitus type 2 even in youngsters. The     researchers will try to investigate the role of this new adipokine in order to early detect     and to prevent similar entities in childhood obesity.   "
249937|NCT01121185|"     The purpose of this study is to determine whether a human monoclonal antibody against     Hepatitis C (MBL-HCV1) is effective in preventing detectable levels of Hepatitis C virus in     patients undergoing liver transplantation due to chronic HCV infection. The study will also     determine if MBL-HCV1 is effective in delaying or reducing the amount of detectable HCV in     patients after transplant.   "
249938|NCT01121198|"     This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of     ASP1941 in healthy adult male subjects.   "
249939|NCT01121211|"     The investigators are investigating whether a hormone that is naturally produced by the human     body, called testosterone, can help improve weight, disordered eating, depression, and     anxiety. The investigators hypothesize that testosterone will be a novel and effective     endocrine-targeted therapy for patients with anorexia nervosa.   "
249940|NCT01121224|"     Patients who have undergone coronary bypass surgery have had a vein removed from the leg and     implanted in the chest to bypass blockages in the coronary arteries. These veins are called     saphenous vein grafts or SVGs. SVGs often develop blockages that can cause chest pain and     heart attacks. SVG blockages can be opened by using small balloons and stents (metal coils     that keep the artery open). Two types of stents are currently used: bare metal stents (BMS)     and drug-eluting stents (DES). Both BMS and DES are made of metal. DES are also coated with a     drug that releases into the wall of the blood vessel to prevent scar tissue from forming and     re-narrowing the vessel. Both stents have advantages and disadvantages: DES require taking     special blood thinners (called thienopyridines, such as clopidogrel or prasugrel) longer than     bare metal stent and could have more bleeding but are also less likely to renarrow. Both BMS     and DES are routinely being used in SVGs, but it is not known which one is better. Neither     bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in     SVGs. The purpose of CSP#571 is to compare the outcomes after DES vs. BMS use in SVGs.      In CSP#571 patients who need stenting of SVG blockages will be randomized to receive DES or     BMS in a 1:1 ratio. Per standard practice, patients will receive 12 months of an open label     thienopyridine if they have acute coronary syndrome (ACS), or if they have another clinical     reason for needing the medication. Patients without ACS who receive DES also need to take 12     months of a thienopyridine whether or not they are in the study, but non-ACS patients who     receive a BMS do not. In order to make sure patients do not know which stent they received,     non-ACS patients who received BMS will receive 1 month of open label thienopyridine followed     by 11 months of blinded placebo, while those who received DES will receive 1 month of open     label thienopyridine followed by 11 months of blinded clopidogrel, which is a thienopyridine.      All study patients will be followed in the clinic for at least 1 year after their stenting     procedure to see if there is a difference in the rate of cardiac death, heart attack, or any     procedure that is required in order to increase the flow of blood to and from the heart     between the BMS and DES groups.   "
249941|NCT01121237|"     MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level     factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin     alfa in Stage 5 CKD patients requiring haemodialysis.   "
249942|NCT01121250|"     This 12-month study is for spouses or significant others of service members who have returned     from Afghanistan or Iraq. This study will determine if participating in a telephone     discussion group, offering education, skills building, and support, will help increase     post-deployment adjustment. There will be 225 spouses recruited for this study.   "
249966|NCT01129609|"     The primary endpoint is successful secondary endovascular treatment with the Talent Converter     stent graft of subjects having received prior endovascular repair of infrarenal abdominal     aortic or aortoiliac aneurysms using the Talent or AneuRx Bifurcated Stent Grafts, in which     there is inadequate proximal fixation, seal, overlapping of modular components or     unattainable contralateral limb cannulation.      Treatment success is defined as a composite of successful vessel access, successful insertion     of the delivery system, successful deployment of the Converter stent graft at the intended     treatment site and absence of Type I endoleak at the 1 month follow-up visit.   "
255158|NCT03270007|"     This is a phase IV, single-center, prospective, open-label, randomized,controlled study   "
249943|NCT01121263|"     The purpose of the study is to get a better understanding of patients who have multi-vessel     coronary artery disease (blockages in more than one vessel bringing blood to the heart) and     have either Hybrid Coronary Revascularization [HCR] (combination of surgery and catheter     procedures to open up clogged heart arteries) or Percutaneous Coronary Intervention [PCI]     (catheter procedures to open up clogged heart arteries). Participation in the study will last     up to 21 months after a patient's heart procedure(s). The study collects information about     the medical care patients receive during their planned procedure(s) and how well they do     following the procedure(s). No new testing or procedures will be done. Patients will receive     only the tests or procedures their doctor already has planned for them. The information     collected should help to plan the design of a pivotal comparative effectiveness study of     hybrid revascularization.   "
249944|NCT01121276|"     This trial is conducted in Europe and in the United States of America (USA). The aim of this     trial is to investigate the absorption and effect in the body of NN1218 in subjects with type     1 and type 2 diabetes.   "
249945|NCT01121289|"     This trial is conducted in Europe. The aim of this trial is to investigate the absorption and     effect in the body of NN1218 in subjects with type 1 diabetes.   "
249946|NCT01121302|"     1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after          single oral doses.        2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how          the study drug enters and leaves your body and how your body acts on the study drug) of          AZD5213 in your blood and urine.      One group of subjects will be studied to see how food affects the pharmacokinetics (PK) of     AZD5213 in the blood and urine. They will receive AZD5213 once after fasting overnight and     then return to the clinic to receive AZD5213 after eating a high fat breakfast.   "
249947|NCT01121315|"     To describe the type II diabetes population in primary care with special reference to     treatment, other diseases and mortality during the last decade. To test the hypothesis that     the type or combination of per oral glucose lowering drugs have different effects on the risk     of cardiovascular disease and diabetic complications.   "
249948|NCT01121328|"     This is a pilot study to test feasibility of collection, preparation and infusion of a baby's     own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born     premature <35 weeks of gestation.   "
249949|NCT01121341|"     The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective     randomized trial for coronary artery bypass grafting (CABG) surgery to compare endoscopic     open CO2 harvesting system versus conventional vein harvesting.   "
249950|NCT01121354|"     The purpose of this study is to demonstrate the safety and pharmacokinetics of Cefazolin 2g     for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System to Cefazolin     1.5g for Injection USP and Dextrose Injection USP in daily doses of 6g in healthy adult     subjects for 11 days of administration.   "
249951|NCT01121367|"     This study is to evaluate the expression of biological markers in induced sputum and     peripheral blood T lymphocytes of patients with combined pulmonary fibrosis and emphysema     (CPFE). The features of CPFE would be observed, including pulmonary function tests and     fractional exhaled nitric oxide （FENO）.   "
249952|NCT01121380|"     The purpose of this study is to test the safety, tolerability and pharmacokinetics of BL-1021     in healthy volunteers. Subsequent clinical studies will be designed to test the safety and     efficacy of BL-1021 in patients with neuropathic pain based on data obtained from the     proposal trial described below.   "
249953|NCT01121393|"     To investigate the efficacy and safety of BIBW 2992 compared to standard first-line     chemotherapy in patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR     activating mutation   "
249954|NCT01121406|"     This is an international, randomized phase II trial. The aim is to assess the efficacy and     the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent     third and fourth lines platinum resistant/refractory ovarian cancer.      100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50     patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be     continued until disease progression or unacceptable toxicity. Primary endpoint: disease     control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version     1.1.      Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour     response, biological progression free survival assessed by serum CA 125 according to     Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease     symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms     questionnaires, pharmacokinetics of BI 6727.      Others endpoints: biomarkers and pharmacogenetics analysis (optional)   "
249955|NCT01121419|"     Neuroblastoma (NB), a common cancer of early childhood originating from primitive sympathetic     neural precursors, is characterized by the remarkable heterogeneity of clinical behaviors     from spontaneous regression to rapid progression and death. The current therapeutic options     are developed according to the Children's Oncology Group (COG) risk stratification criteria     based on clinical and biological factors, including tumor stage, MYCN status, age at     diagnosis, histology, and ploidy status. 1-2 The treatment strategies ranging from     observation alone to intensive multimodality therapy depends on the risk stratification of     three subgroups of low, intermediate, and high risk of death. Despite a number of molecular     and biologic factors has been identified to predict the prognosis, MYCN amplification, which     occurring in roughly 20% of primary NB, is one of the most powerful prognostic factors.3 The     co-opting neurotrophin pathways including the neurotrophin receptors (TrkA, TrkB, and TrkC)     and their ligands (NGF, BDNF, and neurotrophin-3, respectively), which regulate the     differentiation, apoptosis, and growth of neural cells, are also important molecules related     to the prognosis of NB.4 However, a proportion of patients with MYCN nonamplified NB still     presents clinically aggressive progression similar to those of MYCN amplified tumors,     suggesting that other unfavorable molecules exist for the inferior survival.5-6 The IGF-II     RNA-binding protein 3 (IMP3), also known as L532S or K homology domain-containing protein     overexpressed in cancer (KOC), is a member of RNA-binding protein family which includes IMP1,     IMP2, and IMP3. The IMPs are primarily expressed during early embryogenesis and have been     implicated in various post-transcriptional functions, including mRNA localization, cell     growth, and cell migration during early embryogenesis.7-8 The IMP3 orthologue Vg1-RBP in     Xenopus has also been described to promote migration of neural crest cells.9 Recently, the     IMP3 is considered an oncofetal protein by increasing proliferation and invasion in various     cancers including pancreas, kidney, and lung cancers.10-14 The expression of IMP3 is,     however, low or undetectable in adjacent benign tissues.13 These lines of evidence indicate     that IMP3 is capable of a potential biomarker to predict cancer progression and metastasis,     and may serve as a target molecule for cancer therapy.14      oligonucleotide microarray is a powerful tool to do a genome-wide screening of candidate     genes related to cancer prognosis.15 In this study, 22 primary NB tumors were subjected to     oligonucleotide microarray analysis. Among the differentially expressed genes according to     the patients' prognosis, IMP3 showed an especially high expression level in NB tumors     carrying unfavorable prognosis. Further evaluation of IMP3 expression in a large sample size     demonstrated that IMP3 expression could predict an unfavorable prognosis of NB patients     independent of other biomarkers. Targeting of IMP3 expression in a NB cell line did suppress     cell invasion ability, suggesting that IMP3 could not only be a prognostic factor, but also     be a potential therapeutic target of NB.   "
249956|NCT01129479|"     Cognitive impairment after stroke is common and has a major effect on morbidity and quality     of life. Acetylcholinesterase inhibitors have demonstrated benefit in vascular dementia, but     efficacy in treating more circumscribed cognitive deficits following stroke, such as aphasia,     has not been systematically investigated.      This study evaluated the efficacy of Galantamine (Reminyl) in subjects with chronic, stable     non-fluent aphasia secondary to stroke. Subjects enrolled in a double-blind placebo-     controlled cross-over study that employed a comprehensive battery of language tests and     measures of general cognitive and behavioral status that will be used to control for factors     that may influence language functioning. The primary study outcome was a within-subject     comparison of changes in language function and behavioral scores between placebo and     active-treatment phases (12 weeks each). Our hypothesis was that by increasing acetylcholine     levels, and facilitating activity of other neurotransmitters affecting attentional systems,     Galantamine would produce gains in both language and behavioral scores in patients suffering     chronic effects in cognitive systems due to injury following stroke.   "
249957|NCT01129492|"     The purpose of this study is to evaluate whether low-level Laser therapy is effective in     ameliorating the thyroid function of patients with hypothyroidism caused by chronic     autoimmune thyroiditis.   "
250015|NCT01131156|"     The investigators hypothesized that an enriched focus on mother-infant bonding during a     newborn's hospitalization in the Neonatal Intensive Care Unit would reduced the rate maternal     postpartum smoking relapse and would prolong the duration of breastfeeding in mothers who had     quit smoking during or just prior to pregnancy.   "
249958|NCT01129505|"     Our longitudinal aim is to reduce childhood obesity using our two-pronged intervention     program, which includes healthy food choices and increased physical activity initiated during     pregnancy and re-instated in the early period after delivery for overweight and obese women.     We will accomplish this with our family-based Nutrition and Exercise Lifestyle Intervention     Program (NELIP) to promote healthy family living. An intervention targeting school-aged     children on the importance of healthy lifestyles occurs too late to prevent childhood obesity     and establish lifelong healthy body weights. To break this spiraling cycle of generations of     unhealthy body weights in Canadian children, and to reduce the risk of future obesity-related     health problems, it is necessary to prevent excessive pregnancy weight gain, high blood     sugars in the mother and to promote a healthy lifestyle during pregnancy and early post     delivery. With our NELIP team as a cornerstone, and our pilot data already collected with     promising results, we foresee an opportunity over the next 3 years to contribute to changing     patient care with emphasis on disease prevention and healthy family lifestyle initiation     early in life to reverse the trend of childhood obesity. With a solid research-based     initiative from the lab to the community by educating health care providers, future health     care can be improved by putting prevention-based programs into practice.      Healthy women = healthy babies = healthy families = healthy futures!!   "
249959|NCT01129518|"     This open label randomised controlled study will evaluate the induction of immunity following     varying schedules of vaccination with glyco-conjugate Neisseria meningitidis serogroup C     (MenC) vaccines in infancy. 498 infants will be enrolled in this multi-centre trial.     Participants will receive either 0, 1, or 2 priming doses of a MenC-CRM197 conjugate vaccine     or 1 priming dose of a MenC-TT conjugate vaccine in the first year of life, with all groups     receiving a dose of a combination Hib-MenC-TT vaccine at 12 months, as well as all other     concurrent routine vaccinations. All groups will also be further divided into 2 groups to     receive their routine vaccines in either consistent or alternating limbs to assess the immune     response to the concurrent infant routine immunisations administered in consistent versus     alternating limbs. Immune responses will be assessed at 5, 12, 12months +6 days, 13 and 24     months of age.   "
249960|NCT01129531|"     This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic     neuralgia (PHN) - nerve pain.   "
249961|NCT01129544|"     Researchers are working on ways to treat SCID patients who don't have a matched brother or     sister. One of the goals is to avoid the problems that happen with stem cell transplant from     parents and unrelated people, such as repeat transplants, incomplete cure of the immune     system, exposure to chemotherapy, and graft versus host disease.      The idea behind gene transfer is to replace the broken gene by putting a piece of genetic     material (DNA) that has the normal gene into the child's cells. Gene transfer can only be     done if we know which gene is missing or broken in the patient. For SCID-X1, gene transfer     has been done in the laboratory and in two previous clinical trials by inserting the normal     gene into stem cells from bone marrow. The bone marrow is the factory inside the bones that     creates blood and immune cells. So fixing the gene in the bone marrow stem cells should fix     the immune problem, without giving chemotherapy and without risk of graft versus host     disease, because the child's own cells are used, rather than another person's. Out of the 20     subjects enrolled in the two previous trials, 18 are alive with better immune systems after     gene transfer. Two of the surviving subjects received gene corrected cells over 10 years ago.      Gene transfer is still research for two reasons. One is that not enough children have been     studied to tell if the procedure is consistently successful. Of the 20 children enrolled in     the previous two trials, one child did not have correction of the immune system, and died of     complications after undergoing stem cell transplant. The second important reason why gene     transfer is research is that we are still learning about the side effects of gene transfer     and how to do gene transfer safely. In the last two trials, 5 children have experienced a     serious side effect. These children developed leukemia related to the gene transfer itself.     Leukemia is a cancer of the white blood cells, a condition where a few white blood cells grow     out of control. Of these children, 4 of the 5 have received chemotherapy (medication to treat     cancer) and are currently in remission (no leukemia can be found by sensitive testing),     whereas one died of gene transfer-related leukemia.   "
249962|NCT01129557|"     Primary Hypothesis: Aldosterone breakthrough will occur at a far lower frequency during renin     inhibition (0-10% over 9 months), alone or in combination with an ARB, compared to     conventional ARB therapy (35-45% over 9 months). The investigators hypothesize that     aldosterone breakthrough occurs due to accumulation of active precursor substances, most     notably angiotensin II, produced in response to conventional RAAS blockade with ACEinhibitors     and ARBs. The investigators believe that direct renin inhibition (DRI) should minimize this     accumulation and therefore significantly lower or possibly eliminate the breakthrough effect.      Interruption of the renin-angiotensin-aldosterone system (RAAS) with angiotensin-converting     enzyme inhibitors (ACE-Is) and angiotensin receptor blockers (ARBs), alone and in     combination, has become a leading therapy to slow the progression of chronic heart and kidney     disease. Both types of drugs inhibit the formation of aldosterone, a hormone, which has been     shown to have harmful effects on patients with chronic heart and kidney disorders. This     treatment is effective but not perfect since, even after an initial improvement, many     patients become worse over the long term. This may be due to an unexpected increase in     aldosterone, a phenomenon called aldosterone breakthrough.      The purpose of this study is to find out whether the use of a direct renin inhibitor (DRI)     alone, or in combination with an angiotensin receptor blocker (ARB), will lessen the     occurrence of aldosterone breakthrough since direct renin inhibitors inhibit the formation of     aldosterone at a very early step. This study will compare the effectiveness of adding Diovan     (valsartan) or Tekturna (aliskiren) or a combination of Diovan and Tekturna to the usual     antihypertensive treatment. The investigators will follow blood pressure, aldosterone levels,     and urinary protein levels over 9 months to evaluate which of these therapies is most     effective for treating hypertension in patients with proteinuric kidney disease.   "
249963|NCT01129570|"     Milk thistle is an herbal drug that may have some liver protection properties and may reduce     inflammation in the liver. It may also have anticancer effects. However milk thistle is not     approved by the Food and Drug Administration for any medical purpose in the United States.      It has not been used in patients with liver cancer previously, to our knowledge, but there     have been many studies of its use in patients with hepatitis and cirrhosis. Some of these     studies have shown that milk thistle may help reduce elevated liver function tests.      Siliphos is a derivative of milk thistle that can be absorbed better than some other types of     milk thistle. The investigators would like to perform a study to identify doses of siliphos     that are safe to take in advanced liver cancer and to identify positive or negative side     effects this compound may have. The investigators will be using this information in future     studies to see if siliphos can be used as a therapy in patients with advanced liver cancer to     reduce elevated liver function tests.   "
249964|NCT01129583|"     This is a randomized double blind placebo controlled study to investigate the hypothesis that     injection of botulinum toxin A into the muscles surrounding the elbow following the surgical     treatment of an elbow fracture will reduce postoperative stiffness and improve function.   "
249965|NCT01129596|"     The purpose of this study is to investigate the following about donepezil hydrochloride     administration in patients with mild or moderate Alzheimer's Disease in clinical practice:     cognitive function, Functional Assessment Staging (FAST) score, adverse events/adverse drug     reactions, and patient background.   "
250034|NCT01131429|"     Objective: the objective of this study in china is to clarify, whether the overall survival     is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR     mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those     receiving first-line docetaxel/cisplatin plus second-line erlotinib .   "
249967|NCT01129622|"     This study is a primary investigation to determine the usefulness and safety of a short     course of a relatively high dose of letrozole (a medication used to decrease the female     hormone estrogen which is produced locally inside the breast after menopause) in improving     the performance of of breast MRI (Magnetic Resonance Imaging). The inhibition of estrogen in     the breast by letrozole might help better identifying of suspicious areas in the breast and     could assist radiologists in distinguishing between benign breast areas and cancer tissue.     This might help reducing the rate of call backs and unnecessary biopsies for patients. We     expect to enroll 20 healthy postmenopausal women in this study.   "
249968|NCT01129635|"     Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and     morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond     to this intervention. There is retrospective evidence that placement of the left ventricular     (LV) lead at the region of latest mechanical delay markedly improves response to CRT.     However, there is no feasible way to gauge dyssynchrony at LV lead sites during CRT     implantation. Impedance recordings from pacing lead tips allow for real-time assessment of     mechanical motion and may represent a useful intraoperative tool to guide optimum placement     of the LV lead during CRT implantation. This pilot trial will assess the use of     intraoperative impedograms in humans to measure regional dyssynchrony at potential LV lead     locations during CRT implantation.   "
249969|NCT01129648|"     To evaluate safety and efficacy of BCX4208 alone and in combination with allopurinol in     subjects with gout.   "
249970|NCT01129661|"     The purpose of this study is to assess the safety and tolerability of escalating doses of     CSL112 after single intravenous infusions in healthy volunteers and to measure the     pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.   "
249971|NCT01129674|"     The primary purpose of the study is to help answer the following research questions:      How LY 2140023 can be tolerated by patients with Schizophrenia compared to standard of care     treatment in 52 weeks time period.      Whether LY 2140023 can help patients with Schizophrenia.   "
249972|NCT01129687|"     The investigators study is to investigate safety and efficacy of performing a planned     incomplete removal of large acoustic neuroma tumors to decrease surgical morbidity and yet     avoid tumor recurrence by post-operative radiation therapy.   "
249973|NCT01129700|"     Concurrent chemoradiotherapy (CRT)        -  Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1)             -  ↓ ↓ ↓ ↓ ↓                  -  Radical surgery 6 weeks after completion of chemoradiotherapy                       -  ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5        -  5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy   "
249974|NCT01129713|"     To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with     Secretol 80/80 versus Nexium 40 mg daily.   "
249975|NCT01129726|"     Fiberoptic Intubation is the preferred technique to difficult airway. However, when performed     by untrained anesthesiologists, bronchoscopic intubation has a high rate of failure. We want     to know if the Transillumination-guided Fiberoptic Intubation technique can improves the     success rate and time for tracheal intubation performed by inexperienced anesthesiologists;     whether this technique improves the success rate and for normal intubations when performed by     inexperienced anesthesiologists as well is unknown. Therefore, the authors compared the     success rate and time of Fiberoptic Intubation versus the Transillumination-guided Fiberoptic     Intubation performed by anesthesiologists inexperienced in Fiberoptic Intubation.   "
249976|NCT01129739|"     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells     (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg on the subjects     for refractory anemia (RA) and refractory anemia with ring sideroblast (RARS) of     myelodysplastic syndromes (MDS).   "
249977|NCT01129752|"     The purpose of this study is to investigate risk factors associated with depression and how     such factors might be transmitted cross-generationally. The investigators are conducting an     integrative assessment of emotion regulation and stress reactivity in a group of mothers with     and without a history of depression and their daughters.   "
249978|NCT01129765|"     This study evaluates labeling comprehension, ease of use and effectiveness of a new device     for nasal and sinus irrigation and/or aspiration. The device is currently cleared for     professional use and home use with a prescription. This is a usability study to demonstrate     that this device is appropriate for home use.   "
249979|NCT01129778|"     The purpose of this research study is to assess how safe, effective (how well it works), and     tolerable (to put up with) the drug Zegerid is in reducing reflux episodes in patients who     have both gastroesophageal reflux disease (GERD) and Barrett's esophagus. Zegerid has been     approved by the US Food and Drug Administration (FDA) for the treatment of GERD. The     investigators hope to learn the effectiveness of Zegerid for reducing the amount of acid     reflux patients are experiencing in the esophagus (swallowing pipe).   "
249980|NCT01129791|"     The purpose of this small, short pilot study is to determine the feasibility (e.g.,     recruitment, dose acceptance, retention) of a future longer trial comparing the effects of     different types of milk (raw milk, cow's milk, nondairy-milk) on lactose maldigestion.   "
249981|NCT01129804|"     The Network Support project is part of an ongoing effort to improve treatment for alcohol     dependent patients. The Network Support Project is designed to help patients change their     social network from one that reinforces drinking behavior to one that reinforces sobriety.      160 patients will be assigned to one of two treatments. Each of the treatments will last 12     weeks. The first is a Network Support (NS) treatment designed to help patients develop new     acquaintances and social networks. It is expected that alcohol dependent patients will     benefit from increasing their contact with non-drinking people. This NS condition will be     compared to a packaged CBT program for alcoholics (PCBT) that is designed to teach a number     of skills to help people stop drinking, but does not address social networks per se.      In order to better understand what is happening to the investigators patients, the     investigators will be using daily computerized telephone calls to ask about people's     experiences. This will be done both before and after treatment. Patients will also be asked     to participate in follow-up interviews every 3 months for 2 years following the end of     treatment.   "
249982|NCT01130727|"     The purpose of this study is to determine whether green tea or cocoa extracts are effective     in improve endothelial dysfunction in patients with diabetes mellitus and nephropathy and     arterial hypertension.   "
249983|NCT01130740|"     Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of     disability among veterans. Many veterans with OA have significant pain and functional     limitations, even though they receive some medical care for their OA. Efforts are needed to     help veterans to improve OA-related outcomes. This study will examine a comprehensive     approach to helping veterans manage their OA-related symptoms, in the context of a VA     clinical setting. The study examines an intervention aimed at helping veterans with behaviors     that are known to improve OA-related pain and function (such as exercise, weight management,     and coping with pain), as well as helping providers to implement evidence-based     recommendations for clinical care. The intervention is relatively low cost and easy to     disseminate, with the patient component being telephone based. Therefore, if effective, this     intervention could be implemented widely across the VA healthcare system.   "
249984|NCT01130753|"     This study propose neoadjuvant chemotherapeutic role by erlotinib.   "
249985|NCT01130766|"     The prognosis of NSCLC patients with asymptomatic brain metastasis, who are not treated with     SRS or WBRT has not been fully investigated yet. This randomized phase III trial is conducted     to determine the exact role of SRS in NSCLC patients with asymptomatic oligo brain metastases     whether early treatment with SRS would improve survival even in patients with asymptomatic     brain metastasis.   "
249986|NCT01130779|"     Newly developed or progressive brain metastasis during erlotinib treatment is considered     progressive disease requiring change of treatment regimens despite no progression in     extracranial lesions. Given that there is a dissociation in terms of response to erlotinib     between brain and extracranial sites, we intend to conduct this pilot study to determine     whether the continuation of erlotinib treatment can prolong the progression free interval of     extracranial lesions as long as cranial lesion is controlled separately by conventional     treatment modalities such as surgical resection, stereotactic radiosurgery, and whole brain     radiotherapy.   "
249987|NCT01130792|"     The overall goal of this study is to investigate whether the modulatory effects of     probiotics, which are used as food supplements (Lactobacillus GG marketed as Culturelle or     yoghurt) in the gastrointestinal tract promote restoration of intestinal function and enhance     the specific immune response in children with cryptosporidial or rotaviral infections in     South India. Rotavirus and Cryptosporidium spp. are the most important viral and parasitic     causes of gastroenteritis in children in south India. Both infections can lead to severe     dehydrating gastroenteritis in young children and have no specific treatment. Repeated     episodes of diarrhea can result in long term deleterious effects on nutritional status,     possibly due to intestinal damage. Most episodes of infectious gastroenteritis resolve     without specific therapy, the mainstay of treatment being rehydration. However, oral     rehydration remains under-utilized, in part due to the lack of effect on frequency of bowel     movements and duration of illness. Due to the interest in simple, safe and effective measures     to ameliorate the long-term effects of diarrheal illness, there is a growing appreciation for     the potential of certain microorganisms to offer direct benefits to the health of a host.     Probiotics are known to beneficially modulate several host functions, the most important of     which are immune responses and intestinal barrier integrity. The investigators propose to     build on the investigators previous collaborative efforts to conduct pilot studies to provide     a mechanistic understanding of the effect of probiotic supplementation in children with     rotaviral and cryptosporidial diarrhea.      Based on the established efficacy of LGG for the treatment of a variety of diarrheal diseases     and the documented modulation of immune responses and strengthening of intestinal epithelial     barrier function by probiotics, the investigators propose to conduct a Phase I/II     double-blind randomized placebo controlled clinical trial to assess the preliminary efficacy     and safety of LGG vs. placebo in the resolution of symptoms and restoration of intestinal     function in children with either rotaviral or cryptosporidial diarrhea and no other detected     enteric infection. Promising results in this Phase I/II study will provide preliminary data     to power a future randomized trial on these critical outcomes following rotaviral or     cryptosporidial infection.   "
249988|NCT01130805|"     In order to improve survival of metastatic gastric cancer patients, we plan to to conduct a     phase II trial of CapeOx with 800 mg once-daily pazopanib as a first-line chemotherapy in     metastatic gastric cancer patients.   "
249989|NCT01130818|"     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)     oral dose of GLPG0492 compared to placebo in healthy subjects.      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral     administration will be evaluated, and, if applicable, the maximum tolerated dose determined.     Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy     elderly subjects.   "
249990|NCT01130831|"     To assess the percentage of patients on lanthanum carbonate, that achieve Kidney Disease     Outcome Quality Initiative (KDOQI) guideline suggested values for serum phosphorous in     patients previously treated with calcium-based phosphate binder therapy.   "
249991|NCT01130844|"     The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine     following administration in children and adolescents with ulcerative colitis.   "
249992|NCT01130857|"     Despite a large and growing body of knowledge concerning the diagnosis of temporal arteritis,     this potentially crippling disease still requires pathological diagnosis in practically every     case. It seems likely that a correctly estimated clinical probability could help in     evaluating imaging results in a way that might safely obviate temporal biopsy in a large     segment of suspect cases.      With this aim in view, we intend to identify useful clinical items and integrate them in an     appropriate diagnostic pathway.   "
249993|NCT01130870|"     The purpose of this study is to determine if subsensory stimulation (amplitude) will maintain     same continence in patients treated with Sacral Nerve Stimulation (SNS) for faecal     incontinence as stimulation with amplitude at sensory threshold.   "
249994|NCT01130883|"     This post-marketing observational study (PMOS) will be conducted in a prospective,     single-arm, single-country, multicenter format. The investigational sites will be consulting     rooms of GPs (general practitioner), pneumologists and centers with experience in the     treatment of patients with acute infections of trachea, bronchi, AECB (acute exacerbation of     chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a     post-marketing observational study, Klacid SR will be prescribed in usual manner in     accordance with the terms of the local market authorization with regards to dose, population     and indication as well as local guidelines. Objective: to describe the effectiveness of the     treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute     tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic     bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment     6 weeks to 24 months prior to the Klacid SR dose administered within this study.   "
249995|NCT01130896|"     Patients with implanted cardiac devices who meet appropriate entrance criteria undergo     clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety     protocol.   "
249996|NCT01130909|"     This study will provide data to support preclinical to clinical translation by aligning     preclinical and clinical efficacy assay with dose dependent changes in EEG.   "
249997|NCT01130922|"     Roux-and-Y gastric bypass is one of the most common forms of bariatric surgery; due to a     reduction in size of the stomach and intestine, the available surface area for the absorption     of oral drugs is strongly decreased. This may lead to a reduced bioavailability resulting in     a reduced efficacy of the drug. However, in literature there is no information available     about the impact of bariatric surgery on the pharmacokinetics of moxifloxacin. This protocol     evaluates the moxifloxacin plasma levels, the variability between subjects and the absolute     bioavailability, after oral administration of 400 mg moxifloxacin in healthy volunteers who     have had a gastric bypass at least 6 months ago and who now have a stable body weight.   "
249998|NCT01130935|"     This study will assess the effectiveness of Nexium at alleviating upper GI symptoms in     subjects and evaluate with which treatment regimen and on which indications acid suppression     with isomeric proton pump inhibitor is used in routine clinical practice in Albania.   "
249999|NCT01130948|"     This study investigates the effect of altitude exposure on sleep, breathing and psychomotor     performance in healthy subjects.   "
250000|NCT01130961|"     The purpose of this study is to determine progression-free survival of lung cancer patients     who received gefitinib in clinical practice in Thailand.   "
250001|NCT01130974|"     The objective of this study is to evaluate the safety and efficacy of the Bausch & Lomb daily     disposable tint contact lens (Test) compared to a currently marketed daily disposable     cosmetic tint contact lens (Control).   "
250002|NCT01130987|"     The investigators propose to test the hypothesis that implementation of a comprehensive     handoff program (CHP) - i.e., implementation of a computerized handoff tool along with     teamwork training for internal medicine residents on inpatient units at Walter Reed and     Madigan Army Medical Centers - will lead to reductions in resident miscommunications /     medical errors and improvements in workflow and experience on the wards.   "
250003|NCT01131000|"     The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on     reducing fever at 4 hours.   "
250004|NCT01131013|"     The primary objective of this early-stage clinical study is to demonstrate an effect of     single doses of CK-2017357 on measures of skeletal muscle function and fatigability in     patients with peripheral artery disease and symptomatic claudication.   "
250005|NCT01131026|"     Today, although the triple treatment with clarithromycin accepted as the primary treatment     for Helicobacter pylori infection eradication is well tolerated, the eradication has been     decreased to 65 %. However, the eradication resulting from TRIOL treatment with levofloxacin     is expected to be 75 % or higher. If the target results can be reached, it will be concluded     that TRIOL treatment with levofloxacin will be an alternative to the triple treatment with     clarithromycin as the primary treatment.   "
250006|NCT01131039|"     The purpose of the study is to determine whether the administration of bevacizumab and     gemcitabine given by IV infusion can prolong survival, delay tumor growth, and/or shrink     tumors in patients with ovarian cancer, primary peritoneal, or fallopian tube cancer.   "
250007|NCT01131052|"     Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75     years and 40% of adults >80years of age. It is expected that the number of elderly people     suffering from diabetes will increase in the future, as general life expectancy is     increasing.      Nursing home residents with diabetes have higher rates of serious comorbidities and have     greater activity of daily living dependencies than other residents without diabetes. In     addition, persons with diabetes have higher risk of hypertension, heart disease, stroke     depression, cognitive impairment, and cardiovascular mortality than individuals without     diabetes.      There are a few retrospective studies in elderly patients analyzing quality of diabetes care     and glycemic control adjusted for medications and presence of co-morbidities in long-term     care facilities; however, no previous randomized controlled trials have demonstrated benefits     of glycemic control on clinical outcome, quality of life, and rate of acute metabolic     complications (hyperglycemia and hypoglycemic events) in long-term care facilities. In     addition, it is not known whether the use of basal insulin is superior to treatment with     sliding scale insulin (SSI) in long-term care facility residents with type 2 diabetes.      Accordingly, the investigators propose to conduct a prospective randomized control trial     comparing the efficacy and safety of the basal (glargine) insulin regimen and sliding scale     regular insulin in the management of nursing home patients with T2DM.   "
250008|NCT01131065|"     The aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of     Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV)     reinfection in patients submitted to liver transplantation due to HBV-induced liver disease     by reaching and maintaining certain hepatitis B antibody (HBsAg) levels considered as     protective during the first six and twelve months post-transplantation.   "
250009|NCT01131078|"     A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic     cancer of the colon or rectum. The anticipated time on study treatment is until disease     progression.   "
250010|NCT01131091|"     This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are     planned (5 groups of 6 subjects each.)   "
250011|NCT01131104|"     Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective,     case-crossover study to evaluate the possible association between the use of     phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior     ischemic optic neuropathy (NAION) in males. Subjects with newly diagnosed NAION will be asked     via a structured questionnaire about their use of PDE5 inhibitors and other risk factors     prior to the onset of their vision loss.   "
250012|NCT01131117|"     The overall goal of this project is to understand how a mother's health at conception may     influence her child's growth and development.   "
250013|NCT01131130|"     The objective of this study is to determine the product feasibility of the investigational     contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens     (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft     contact lenses.   "
250014|NCT01131143|"     This study will test the effect of provider to patient interactive voice response (IVR) calls     in local Community Health Centers within a weight management program.   "
250035|NCT01131442|"     Currently, the pathophysiology of Irritable bowel syndrome( IBS) remains unclear . The     purpose of this study is want to investigate the immunological changes in the children with     IBS.   "
250016|NCT01131169|"     The patients are being offered a stem cell transplant. Stem cells are very early blood cells.     They have not yet matured to become red or white blood cells or platelets. They have already     received the standard treatment of chemotherapy and an autologous stem cell transplant. An     autologous stem cell transplant is when the patient receives their infusion of their own     cells. Thi will give the patient a better chance of curing the disease, this protocol     includes an infusion of stem cells from the blood (or the bone marrow) of another person.     This is called an allogeneic stem cell transplant. The stem cells will begin to grow in the     bone marrow and produce new blood cells.      Allogeneic stem cell transplants can cause a condition called graft-versus-host disease or     GVHD. In GVHD, a kind of white blood cell from the donor (graft) begins to attack the body     (host). That blood cell is called a T-cell. It is a cell that normally helps to protects     against things like bacteria and viruses. In this case, the donor's T-cells see the body as     foreign in the same way they would see bacteria as foreign. GVHD can be fatal. In order to     lower the chance that the patient will get GVHD this protocol treatment will remove the     T-cells from the donor's cells. This is called T-cell depletion. The T cells are removed by a     system called Clinimacs. This method is still being evaluated through clinical trials and     not been approved by the Federal Drug Administration (FDA) at this time.      Before the transplant, the physician will treat the bone marrow to get rid of the cancer. The     physician uses three chemotherapy drugs plus ATG. The chemotherapy drugs (Busulfan, Melphalan     and Fludarabine) kills the cancer. ATG gets rid of any of the patients T cells that survive     the chemotherapy. This ensures that the donor stem cells are not rejected. The patient will     also receive additional white blood cells called lymphocytes from the donor. This is called a     donor lymphocyte infusion or DLI. These additional infusions will help cause a     graft-versus-myeloma effect and can help the donor stem cells grow.   "
250017|NCT01131182|"     This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan     is lower when treated with sitagliptin as compared to sulfonylurea treatment.   "
250018|NCT01131195|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     paclitaxel, cyclophosphamide, and capecitabine, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet     known whether bevacizumab is more effective when given together with paclitaxel or     cyclophosphamide and capecitabine in treating patients with breast cancer.      PURPOSE: This randomized phase III trial is studying the side effects of giving bevacizumab     together with paclitaxel and to see how well it works compared with giving bevacizumab     together with cyclophosphamide and capecitabine as first-line therapy in treating women with     locally advanced, recurrent, or metastatic breast cancer.   "
250019|NCT01131208|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer. It may also help doctors     predict how well patients will respond to treatment.      PURPOSE: This research study is studying biomarkers in patients with diffuse large B-cell     lymphoma treated with combination chemotherapy with or without rituximab.   "
250020|NCT01131221|"     RATIONALE: Studying samples of serum from patients with cancer in the laboratory may help     doctors identify and learn more biomarkers related to cancer. It may also help doctors     predict how well patients will respond to treatment.      PURPOSE: This research study is studying vitamin D insufficiency in determining prognosis in     patients with newly diagnosed follicular lymphoma.   "
250021|NCT01131234|"     This phase I clinical trial is studying the side effects and best dose of giving     gamma-secretase inhibitor RO4929097 and cediranib maleate together in treating patients with     advanced solid tumors. Gamma-secretase inhibitor RO4929097 and cediranib maleate may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib     maleate also may stop the growth of tumor cells by blocking blood flow to the tumor.   "
250022|NCT01131247|"     Investigational Drugs:      Ofatumumab (Azerra) + bendamustine (Trenda)      Route of Administration:      Intravenous (IV)      Hypothesis:      This study is designed to assess the toxicity and overall response rate. Ofatumumab is a     fully human monoclonal antibody (A type of protein made in the laboratory that can bind to     substances in the body, including tumor cells) that shows promising activity in the treatment     of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA     approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given     alone. Ofatumumab is FDA approved for the treatment of relapsed/refractory CLL.      Participation:      Approximately 37 relapsed/refractory CLL subjects will participate in this study over two     years.      Treatment Plan:      A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV     300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by     bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be     administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only     patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will     be given on day 1 only.      Follow-up:      Patients will be followed monthly for six months, then every three months for five years then     annually thereafter.   "
250023|NCT01131260|"     The purpose of this research is to test a new instrument, called a fetal STAN monitor, that     may be used during labor to monitor the electrical activity of the baby's heart. This new     instrument is designed to help the doctor determine how well the baby is doing during labor.     It will be used along with the existing electronic fetal monitor used to measure the baby's     heart rate and the mother's contractions during birth. The specific purpose of this research     study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn     health.   "
250024|NCT01131273|"     This study will obtain pilot data on the acceptability of a 12-week course of daily observed     suboxone and methadone, followed by a dose taper or referral to a local treatment program for     80 opioid dependent patients (40 group) who have been injecting subutex or other     buprenorphine preparations 10 or more days in the past 30, and on the impact of each     medication on HIV risk and on subutex and opioid use during treatment and a followup at week     20. it will be done at the Uranti Methadone Program, affiliated with the Addiction Research     Center, Union Alternative of Georgia in Tbilisi.   "
250036|NCT01131455|"     To compare the outcomes of patients who undergo three different types of surgeries for ankle     fusion and reconstruction.   "
250037|NCT01131468|"     The purpose of this study is to determine whether N-acetylcysteine is effective in the     prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced     ototoxicity in peritoneal dialysis patients.   "
250038|NCT01131481|"     Evaluation of glistenings in intraocular lenses implanted in normal patients following     routine cataract surgery. The lenses used will be Model X-60 made by the AVS company Vs     AcrySof MA50BM made by the Alcon company.   "
250379|NCT01133444|"     The objective of this study was to compare the single-dose relative bioavailability of Dr.     Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®)      1 mg finasteride tablets under fasting conditions following administration of a 3 mg dose.   "
250025|NCT01131299|"     Background:        -  Cardiovascular disease (CVD) is a leading cause of death in developed countries.          Although statin-type drugs are currently the most effective therapeutic agents for          reducing CVD risk. One possible complementary approach involves the use of soluble          dietary fibers that are known to reduce blood cholesterol levels. However, analysis has          shown that most soluble fibers reduce total cholesterol levels by relatively small          amounts.        -  Alpha-Cyclodextrin (Alpha-CD), also sold in commerical form, is a soluble fiber derived          from corn that is used as an ingredient in many foods, such as bread rolls, crackers,          juices, and reduced fat spreads. It is added to food primarily as a fiber supplement but          is also used to stabilize flavors, colors, vitamins, and fatty acids. Studies in animals          and humans have shown that Alpha-CD may help to improve insulin resistance and lower LDL          cholesterol levels with no apparent side effects. More research is needed to determine          the effect of Alpha-CD on total cholesterol levels in healthy volunteers.      Objectives:      - To determine the effect of oral Alpha-CD on total cholesterol in a nondiabetic population.   "
250026|NCT01131312|"     Approximately 65 million Pap smears are performed each year in the United States. The vast     majority of results are negative (no abnormality identified) but about 5 percent to 8 percent     are reported as abnormal. Most low-grade changes regress spontaneously; only a minority of     such lesions would progress to a cancer precursor without treatment. However, there is no way     to determine morphologically which patients are at risk or progression. Therefore, both high-     and low-grade lesions were often managed with colposcopy and directed biopsy. It was     anticipated that determining alternative management strategies would yield important     potential benefits including fewer medical complications from over treatment, reduced patient     anxiety associated with referral for cytologic abnormalities, as well as cost savings.      Epidemiologic, virologic and molecular studies have clearly demonstrated that human     papillomavirus (HPV) is the central cause of cervical cancer. The motivation for the ALTS     trial was to use the information we have gained about the role of HPV to design better     treatment and prevention strategies to reduce the burden of cervical cancer and its     precursors.      ALTS consisted of three management strategies: (1) immediate colposcopy of all women; (2)     repeat cytology with colposcopy only if the results show a high grade lesion; and (3) HPV     testing and repeat cytology in combination, with referral to colposcopy if either the HPV     test is positive or the cytology shows a high grade lesion. Four Clinical Centers University     of Alabama, Birmingham AL; Magee-Womens Hospital, Pittsburgh PA; University of Oklahoma,     Oklahoma City OK; and University of Washington, Seattle WA enrolled approximately 5,000 women     with recent diagnosis of ASCUS or LSIL. Participants were followed at six month intervals for     a total of 2 years. The main results from ALTS showed that for women with ASCUS cytology, HPV     triage was at least as safe as universal immediate colposcopy in the detection of high-grade     lesion and would allow approximately half of women to return to routine follow up without     additional procedures (colposcopy). No efficient triage strategy was identified for women     with LSIL cytology.      The ALTS database and ALTS specimens continue to be a valuable research resource in studies     of cervical cancer precursors, screening tests, visual assessment of the cervix and     investigation of biomarkers.   "
250027|NCT01131325|"     This study is to determine the number of European Leukemia Network (ELN)guideline defined     treatment failure events from time of study entry in CML-CP patients with low imatinib trough     concentrations treated with nilotinib.   "
250028|NCT01131351|"     The purpose of this study is:        -  To evaluate the safety and tolerability of orally administered OPC-67683 when          administered two times daily (BID) to MDR TB patients refractory to treatment with an          optimized background regimen of anti-TB medications (OBR).        -  To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.   "
250029|NCT01131364|"     This Phase Ib/II study is an openlabel, multicenter study for patients with solid tumors and     breast cancer amenable to anthracyclin therapy.      The study is divided in two parts:      Phase I: an open-label, dose escalation study of F16IL2 in combination with doxorubicin for     patients with solid tumors.      Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in     combination with doxorubicin, equivalent to stage 1 of the Simon two-stage phase II design,     for patients with breast cancer amenable to anthracyclin therapy.   "
250030|NCT01131377|"     Metabolic alkalosis(MA) is common metabolic disorder in ICU setting. MA could be cause of     weaning failure or delay by depression of respiratory center. The purpose of this study is to     evaluate that correction of MA by administration of acetazolamide facilitates weaning of     mechanical ventilation.   "
250031|NCT01131390|"     No studies have been done to examine whether patients with obstructive lung disease and     obesity are more comfortable on some ventilator settings than on others. The purpose of the     current study is to examine this question systematically.   "
250032|NCT01131403|"     Study design:      The purpose of the present study is to analyse of the influence of the application of the     skin care products on the diaper area (Factor A) and the application of a cotton wool cloth,     moistened with clear water on the diaper area (Faktor B) on the skin barrier function of the     newborns during the first four weeks. Additionally, the microbiological colonisation of the     skin will be observed. After four weeks all infants in both groups will obtain wet wipe and     after 8 weeks a facultative measurement will be performed.      Primary and secondary end points:      In the present study, as a primary end point TEWL on the buttock was chosen, because the     significant difference between the infants who were bathed and washed in the previous study     was found.      Secondary end points are the TEWL on the other measuring points, pH-value and SCH.     Additionally, secondary end points are the D-Squame method and the cytokine measurement with     Sebutapes.      Hypotheses:      The intention of the study is to evaluate, whether the using of wet wipe on the diaper area     has an influence on the TEWL of the newborns. The following hypotheses are present below:      H0 (Null hypothesis): The TEWL is indistinguishable between infants who get cleaned with wet     wipe on the diaper area and infants who get cleaned with a cotton wool cloth, moistened with     clear water on the diaper area, i.e.      TEWL clear water is equal TEWL wet wipe against H1 (Alternative hypothesis - bilateral): The     TEWL is distinguishable between infants who get cleaned with wet wipe on the diaper area and     infants who get cleaned with a cotton wool cloth, moistened with clear water on the diaper     area, i.e.      TEWL clear water is not equal TEWL wet wipe   "
250033|NCT01131416|"     Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have     traditionally withheld postoperative oral intake until the return of bowel function to     prevent related complications. Gum chewing can stimulates bowel movement and promotes the     return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes     secretion.      The objectives of this study are to examine effects of adding gum chewing to the conventional     postoperative feeding regimen on the return of bowel function, its related complications, and     patients' satisfaction.   "
250380|NCT01133457|"     The objective of this study was to compare the single-dose relative bioavailability of Dr.     Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®)      1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.   "
250039|NCT01131494|"     Dysphagia in Parkinson's disease(PD) is common and its presence is related to motor and     sensory abnormalities, and incoordination between swallowing and breathing. Despite harming     as respiratory infections and increased risk of death, treatment of this condition remains     uncertain. This study aims to evaluate the effect of oral motor exercises on the swallowing     dynamics and quality of life of dysphagic Parkinson's disease patients. This study is an open     trial, self-paired and blinded to the examiner. The participants will perform oropharyngeal     exercises for five weeks and will be evaluated before and after intervention by swallowing     videofluoroscopy and questionnaires about quality of life in dysphagia (SWAL-QOL).   "
250040|NCT01131507|"     A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008)     3,000 lipase units (Zenpep® [pancrelipase] delayed release capsules) in infants with exocrine     pancreatic insufficiency (EPI) due to cystic fibrosis (CF).   "
250041|NCT01131520|"     The purpose of this study is to compare the effectiveness in reducing drug use and its     associated problems of a brief intervention for drug use delivered by a behavioral health     counselor as compared to a brief intervention delivered by a computerized intervention.   "
250042|NCT01131533|"     The investigators investigate intraocular concentrations and pharmacokinetics of     erythropoietin after a single intravitreal injection in humans.   "
250043|NCT01131546|"     This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or     5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential     hypertension.   "
250044|NCT01131559|"     The specific aim of this study is to evaluate the efficacy and tolerability of     lisdexamfetamine in the adjunctive treatment of bipolar disorder.   "
250045|NCT01131572|"     This study tests NAC in the treatment of Bulimia Nervosa.   "
250046|NCT01131585|"     This study was designed to confirm the efficacy and safety of laser photocoagulation as     adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual     impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic     Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as     adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.   "
250047|NCT01131598|"     The investigators propose to perform a one-year prospective audit of all Acute lung injury     (ALI)and cute respiratory distress syndrome (ARDS) pediatric patients managed in several ICUs     in Spain. The investigators intend to collect data from all children (from 1 month to 18     years of age) admitted with or developing ALI/ARDS with the aim to understand the     epidemiology and natural history of acute lung injury in the pediatric setting. These ICUs     are scattered through the Spain and are representative of the demographic differences across     the country.   "
250048|NCT01131611|"     The overall objective of this application is to conduct a two-group randomized controlled     trial (RCT) to gather preliminary evidence on the efficacy of a brief cognitive-behavioral     based PT (CBPT) intervention in patients at-risk for poor outcomes following lumbar spine     surgery for degenerative conditions. Our central hypothesis is that incorporating cognitive     and behavioral strategies into postoperative standard of care PT will improve surgical     outcomes, through reductions in fear of movement and pain catastrophizing. We have     established the feasibility of training therapists in the CBPT intervention, recruiting and     retaining patients, and the procedures for data collection and study management. The     long-term goal is to broaden the availability of well-accepted and effective CBT strategies     by expanding the implementation from traditional providers, psychologists, to a group of     providers, physical therapists, who routinely interact with musculoskeletal pain populations.   "
250049|NCT01131624|"     The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron     therapy (iron that is infused directly into your body through a vein), compares with ferrous     sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during     pregnancy.   "
250050|NCT01131637|"     The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of     heart failure.   "
250051|NCT01131650|"     Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil      Abstract      Objective: To determine the prevalence and characteristics of diabetic retinopathy (DR) among     patients from São José do Rio Preto-SP-Brazil .      Local: Departamento de Retina e Vítreo do Hospital do Olho de Rio Preto (HORP)      Methods: Design: population-based cross-sectional study. The study sample, of 710 patients     was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program)     of São José do Rio Preto . All patients , known to have diabetes , underwent an eye     examination by biomicroscope and indirect ophthalmoscope to check for any signs of DR through     dilated pupils. Participants were also interviewed and examined to determine their     demographic characteristics, medical conditions and the realization of previous fundoscopic     eye examination. Statistical studies were done with t -Student test , Fisher test or     chi-square test.   "
250052|NCT01131663|"     Face masks are used for many respiratory care applications such as anaesthesia,     resuscitation, and aerosol therapy. None of the currently available face mask for infants and     young children are specifically designed and developed for infants. The aim of this study is     to design, develop and test the first infant's oriented face mask.      To achieve this ultimate goal we will first define appropriate sizes of infants' faces that     would be used as templates for the design and development of optimally fitted model masks. In     the next stage we will use these masks and incorporate the infants' own soother (pacifier)     into a new SootherMask (SM). In the last part of the study we will compare acceptance levels     between Soothermask (SM) and a conventional commodity masks without a pacifier.   "
250053|NCT01131676|"     The aim of the present study is to investigate the safety of BI 10773 treatment in patients     with Type 2 Diabetes Mellitus and high cardiovascular risk.   "
250054|NCT01131689|"     In preclinical studies, 5-fluorouracil, one of the active metabolites of S-1, showed     synergistic effect to sorafenib in human colon carcinoma cell lines. Therefore, sorafenib     combined with S-1 might be more effective treatment for patients with advanced HCC than     sorafenib monotherapy. The investigators propose to conduct a phase I study to determine     maximal tolerated dose (MTD) of S-1 in combination with fixed dose of sorafenib in patients     with advanced HCC   "
250055|NCT01131702|"     The purpose of this study is to compare the rate and extent of absorption of ranitidine 300     mg tablets versus Zantac 300 mg tablets administered as 1 x 300 mg tablet under fasting     conditions.   "
250056|NCT01131715|"     A pharmacist follow-up procedure is under development. Patients with coronary heart disease     (CHD) is being followed up by a pharmacist for one year with three meetings; at discharge     from hospital, after three months and after one year. The evaluation is basically based on     quantitative measures as achievement of therapeutic goals, number of drug related problems     detected, hospitalisations etc. However, the patients' own experience with the follow-up     procedure cannot be evaluated using these measures. Thus, a qualitative approach is needed.     In this study, a total of four patients participating in the follow-up will be included and     interviewed. A semistructured interview guide will be used. Interviews will be taped,     transcribed and analyzed with the intention to explore how patients experience the follow-up     from the pharmacist. A thoruough content analysis will be performed. Patients included must     have met the pharmacist at least twice. The pharmacist in charge of the follow-up will     recruit patients and hand out study information. Patients will reply to the principal     investigator of the study and thus kept anonymous for the pharmacist in charge of the     follow-up. No pressure will be put on the patients to join, but it will be emphasized that it     will help evaluating the procedure.   "
250057|NCT01131728|"     The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg +     Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in     healthy adult human subjects, under fasting conditions.   "
250058|NCT01131741|"     The purpose of this study is to determine whether changes in perfusion index can be used for     detecting intravascular injection of an epinephrine in anesthetized adults and to compare its     reliability with criteria using changes in heart rate, systolic blood pressure or T-wave     amplitude.   "
250059|NCT01131754|"     Flushes with saline solution are used for maintaining patency of peripheral intermittent     intravenous catheters in many institution based on the results of previous studies showing     that 10 U heparin/mL is not better than saline in this respect. The latest meta-analysis     investigated also safety and efficacy of heparin concentrations of 100 U/ml used as an     intermittent flush, but no firm conclusion was reached because of limitations of the few     available studies.   "
250060|NCT01131767|"     The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg +     Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in     healthy adult human subjects, under fed conditions.   "
250061|NCT01131780|"     The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg +     Pseudoephedrine HCL 30 mg under fasting conditions.   "
250062|NCT01131793|"     A single center Pilot Clinical Registry Study of the Acute Procedural Safety and Efficacy     of Stereotaxis PowerAssert(TM)RF Coronary Total Occlusion System assisted Angioplasty in the     Treatment of Refractory Coronary Total Occlusions   "
250063|NCT01131806|"     Chronic obstructive pulmonary disease is characterized as inflammatory airway with not fully     reversible airflow limitation.Combination treatment with inhaled corticosteroid (ICS) and     long-acting β2 agonists (LABA)attains an improved control of symptoms and lung function, that     are superior to those associated with either drug alone. However, the treatment efficacy     between high and medium dose of inhaled corticosteroid in combination of LABA is still     unknown. The aim of the current study is to investigate the treatment efficacy with high and     medium dose of fluticasone in combination with salmeterol in COPD patients.   "
250064|NCT01131819|"     Purpose: The investigators wish to determine if a rehabilitation program for subjects with     new, trans-tibial amputations that has the balance portion of the program augmented by the     use of the Nintendo Wii fit ™ balance board improves their performance.      Hypothesis: The investigators hypothesize that subjects will benefit from the use of the     device and that this will manifest as an improvement on outcome measures.   "
250065|NCT01131832|"     The substantial range of individual responsiveness to plant sterols has important     ramifications. Marked differences across individuals in particular aspects of the cholesterol     metabolic pathway must alter the impact of plant sterol consumption. As such, a pronounced     need exists to understand the genetic and metabolic factors that explain the substantial     degree of heterogeneity in response of lipid concentrations to plant sterols across     individuals. The primary focus of this trial is to delineate the impact of differing     cholesterol synthesis levels on response of LDL-C and other plasma lipids to plant sterol     consumption. Participants pre-identified as high or low endogenous cholesterol synthesizers,     according to their screening level of lathosterol to cholesterol ratios, will be given PS or     a placebo containing margarine to consume under supervision for 4 weeks in a crossover     design. The trial will characterize the responsiveness of the participants' total, LDL, and     HDL cholesterol, as well as triacylglycerol (TG) concentrations, to plant sterol consumption.     This research will determine if cholesterol synthesis phenotype predicts the responsiveness     of lipids to plant sterol consumption. Variations in candidate genes involved in cholesterol     metabolism will also be investigated in order to find associations with both cholesterol     metabolism phenotypes and responsiveness of lipids to plant sterols. The output of this     research will be to advance the knowledge of which genetic factors influence the degree of     cardiovascular benefit derived from plant sterols through lipid lowering.   "
250066|NCT01131845|"     This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR     pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end     stage renal disease (ESRD; on dialysis).      Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose     will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis.      Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6,     8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with     ESRD will have a sample taken at 60 hrs post dose.   "
250067|NCT01131858|"     Hypothesis: Cholecalciferol (vitamin D3) prevent respiratory tract infections in patients     with primary immunodeficiency.   "
250106|NCT01132365|"     Objective      Describe the clinical and demographic characteristics of patients who undergo knee     arthroplasty and document post operative outcomes.      Examine the relationship between processes of care, hospital and surgeon associated outcomes.      Provide expanded data to characterize existing and evolving practice patterns, delivery of     care, and resource utilization in the management of knee arthroplasty patients.      Analyze and design ancillary studies to address unanswered questions.      Disseminate findings through publication in peer-reviewed scientific journals.   "
250068|NCT01131871|"     The prevalence of obesity in young adults has been increasing, and excessive body weight have     been linked to numerous chronic conditions including cardiovascular disease, diabetes, many     forms of cancer, and numerous musculoskeletal problems. This study will focus of the     development and evaluation of interventions that may be appropriate for young adults (age     18-35 years) to improve weight loss outcomes following a 24 month intervention. The primary     aim of this study is to examine whether an enhanced weight loss intervention (EWLI) that     includes technology components results in improved weight loss in young adults (18-35 years     of age) compared to a standard behavioral weight loss intervention (SBWP) over a period of 24     months. Eligible participants will also be assessed for body composition, body fat     distribution, fitness, physical activity, dietary intake, and behavioral/psychosocial     measures that may be predictive of behavior change. Assessments will occur at 0, 6, 12, 18,     and 24 months. Subjects will participate in a 24 month behavioral weight loss program that     includes a reduction in energy intake and moderate-to-vigorous intensity exercise     (progressively increasing from 100 to 300 minutes per week). The technologies added to EWLI     are text messaging, a wearable device that provides feedback on physical activity, and access     to a website to monitor dietary behaviors.   "
250069|NCT01131884|"     Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in     acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry     (DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months     and be required to take oral fosamax versus placebo weekly.   "
250070|NCT01131897|"     The purpose of this study is to compare the single-dose relative bioavailability study of     Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under Fasting conditions.   "
250071|NCT01131910|"     The investigators intend to check whether the efficacy of a TBE-vaccine is substantially     deteriorated in patients with rheumatoid arthritis who are treated with drugs which suppress     the immune system. The investigators aim to detect a difference of at least 10 % compared to     healthy individuals (historical controls) in protection when analysed with serology. If the     investigators detect a difference, the investigators will continue to explore whether     protection can be achieved by additional doses   "
250072|NCT01131923|"     The purpose of this study is to determine the pharmacokinetics and bioequivalence of     amlodipine besylate formulations under fasting conditions.   "
250073|NCT01131936|"     The purpose of this study is to determine the pharmacokinetics and bioequivalence of     amlodipine besylate formulations under fed conditions.   "
250074|NCT01131949|"     The purpose of this study is to determine the pharmacokinetics and bioequivalence of     lamotrigine formulations after administration of single doses to non-smoking, healthy     volunteers under fasted conditions.   "
250075|NCT01131962|"     Band ligation and injection sclerotherapy are two modalities of treatment that are applied     using the endoscope. The purpose of this study is to determine which of two methods is better     for controlling bleeding from the upper gut.   "
250076|NCT01131975|"     The purpose of this study is to determine the pharmacokinetics and bioequivalence of     Lamotrigine formulations after administration of single doses to non-smoking, healthy males     and females under fed conditions   "
250077|NCT01131988|"     The purpose of this study is to compare the relative bioavailability study of tacrolimus     capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under fasting     conditions and to monitor safety of subjects   "
250078|NCT01132001|"     This is a prospective study comparing the three blood pressure monitoring methods on the     diagnosis of arterial hypertension. Blood pressure of each subject will be evaluated with     clinic, home and 24h ambulatory blood pressure measurements in three visits   "
250079|NCT01132014|"     This is a Five cohort sequential clinical trial for subjects with recurrent ovarian,     fallopian tube, or primary peritoneal cancer to determine the feasibility and safety as well     as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells     (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered     intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide or in     combination with intravenous Bevacizumab, cyclophosphamide and aspirin. Study duration is 24     months.   "
250080|NCT01132027|"     The purpose of this study is to compare the relative bioavailability study of tacrolimus     capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under non-fasting     conditions and to monitor safety of subjects.   "
250081|NCT01132040|"     The purpose of this study is to assess the bioavailability of Primidone 50 mg tablets of     Dr.Reddy's comparing with that of Mysoline@ tablets of Yamanouchi Pharma Technologies Inc, in     healthy, adult, human subjects under fasting conditions.   "
250082|NCT01132053|"     This is a continuation of our previous studies on Progressive Multifocal Leukoencephalopathy     (PML). We will focus on the role of inflammation in PML, and define prognostic markers of     disease evolution.   "
250083|NCT01132066|"     The purpose of the research study is to investigate the effect of a brain stimulation     technique called Transcranial Direct Current Stimulation (TDCS) in improving swallowing     functions in subjects who develop dysphagia after a unilateral hemispheric infarction.   "
250107|NCT01132378|"     The purpose of this study is to compare two different surgical approaches for total knee     replacement surgery. The mini-midvastus approach involves cutting less of the thigh muscle     (quadriceps) tendon than the classic approach (median parapatellar) in order to implant the     knee components. Both will have the same skin incision.   "
250158|NCT01133041|"     Several novel imaging technologies are currently used for detection and differentiation of     colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan     (Pentax).      Several previous studies have indicated that NBI without magnification can be useful for     real-time differentiation of diminutive colonic neoplasias.      To date, however, there are no studies comparing NBI with other imaging systems (FICE or     i-Scan) for differentiation of diminutive colonic polyps.      The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in     real-time prediction of diminutive colonic polyps.      In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will     be observed with conventional colonoscopy, thereafter will be observed with new imaging     systems.      Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by     reference to histological results obtained by endoscopic biopsy or polypectomy.   "
250084|NCT01132079|"     This study seeks to investigate the role of pimecrolimus in restoring disturbed skin barrier     function and reversing epidermal abnormalities found in atopic dermatitis (AD). The project     is based on findings the investigators presented at the recent SID meeting in Providence and     published in the J Invest Dermatol (122: 1423-31, 2004). The investigators research shows     that AD is characterized by impaired skin barrier function, reduced stratum corneum     hydration, impaired epidermal lipid composition and epidermal differentiation. In this     proposed project, the investigators wish to examine the influence of pimecrolimus and     betamethasone valerate on transepidermal water loss (TEWL) as a marker of the skin barrier     function, on stratum corneum hydration, on stratum corneum lipid content and on epidermal     differentiation regarding keratins and cornified envelope proteins in AD patients. The study     involves biophysical measurements of TEWL and skin hydration, lipid analysis,     immuno-histochemistry, Western blotting and micro array techniques. This study shall clarify     whether pimecrolimus restores the epidermal barrier and whether this contributes to the     beneficial effect of pimecrolimus on AD.      Objectives:      To explore the stratum corneum hydration, transepidermal water loss, capacity for barrier     repair and the integrity of the stratum corneum in patients treated with 1 % pimecrolimus     cream when applied twice a day to atopic dermatitis of the upper limbs, and to access the     substance's influences on the epidermis through histological, ultra-structural, and     biochemical analysis using punch biopsies from day 1 of one arm and day 22 from both treated     arms. 0.1 % betamethasone valerate cream b.i.d will be used as a control treatment.   "
250085|NCT01132092|"     There are no differences between the exams made with the new device,that evaluates the     hearing, and the device gold standard, that is widely used in clinics and hospitals.   "
250086|NCT01132105|"     The bioelectrical responses of muscle, evoked by sound, obtained with a device considered the     gold standard (widely used in clinics and hospitals) are similar to those obtained with a new     device developed   "
250087|NCT01132118|"     The purpose of this study is to determine whether hydroxychloroquine (HCQ) reduces insulin     resistance in non-diabetic subjects with rheumatoid arthritis (RA). The investigators will     conduct a double-blind randomized crossover trial in subjects with RA to test the hypothesis     that HCQ improves insulin sensitivity. The investigators will also use data from the trial to     identify determinants of insulin resistance in RA. The investigators hypothesize that RA will     be associated with an increased risk of insulin resistance and that independent risk factors     for increased insulin resistance in RA include higher BMI, elevated acute phase reactants,     greater fat to muscle ratio, and less physical activity.   "
250088|NCT01132131|"     The Emergency Ward Center in Oslo has the last two years used a questionnaire to identify     patients who qualify for treatment of acute cystitis by the use of a delegation form.      The aim of the study is to evaluate this practice, the primary objective being to evaluate if     in a selected patient group the treatment outcome after identifying patients with probable     acute cystitis by delegation form will be as good or better than the treatment received after     a regular doctor's consultation.      The planned study will also investigate which symptoms, signs and laboratory findings that     coincide with significant bacteruria.      The reference standard will be a microbiological culture of every patients urine.   "
250089|NCT01132144|"     The objective of this study is to evaluate the effect of endometrial injury performed prior     ovulation induction for assisted reproductive techniques main outcomes.   "
250090|NCT01132157|"     Ischemia/reperfusion (IR) injury is the major cause of early renal dysfunction and acute     renal failure of the transplanted kidney after renal transplantation. In 1986, Murry et al.     described the phenomenon ischemic preconditioning. Also, it was reported that a few     non-ischemic stimuli could provide cellular tolerance against major ischemia through a     mechanism similar to ischemic preconditioning. In an animal study, 1 minimal alveolar     concentration of volatile anesthetics - a clinically relevant concentration - was reported to     have a protective effect against ischemia/reperfusion injury, the effect being variable     between types of anesthetics. Also, there were somm reports that intravenous anesthetics such     as propofol could reduce IR injury by decreasing oxidative stress and apoptosis.      By reducing the ischemia/reperfusion injury of the grafted kidney, the morbidity and     mortality related to renal transplantation can be reduced as well. The objective of this     study is to find out whether, according to the type of anesthetics (Desflurane vs. Propofol),     there is a difference in the protective effect against ischemia/reperfusion injury of the     grafted kidney in patients receiving renal transplantation.   "
250091|NCT01132170|"     The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets     500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy     subjects.   "
250092|NCT01132183|"     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,     crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with     Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fasting conditions.   "
250093|NCT01132196|"     The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets     500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy     subjects.   "
250094|NCT01132209|"     The objective of the study is reduction of the incidence of the most frequent complication of     abdominal surgery, incisional hernia. In this multi center double-blinded prospective     randomized controlled trial, in which a new suture technique using small bites is compared     with the traditionally applied large bites (mass closure) technique for midline incisions.   "
250095|NCT01132222|"     The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg +     Pseudoephedrine HCL 30 mg under fed conditions.   "
250096|NCT01132235|"     The purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg     subcutaneous injections twice weekly for 12 weeks in subjects who have previously been     treated etanercept and efficacy diminished.   "
250097|NCT01132248|"     Urinary schistosomiasis is a debilitating disease in Central Africa and pregnant women are     frequently suffering from this condition. Mefloquine is currently investigated as preventive     treatment against malaria in pregnancy and mefloquine is also known to exert activity against     schistosomiasis. The investigators want to test the hypothesis whether mefloquine may active     against urinary schistosomiasis when used as preventive treatment against malaria in     pregnancy.   "
250098|NCT01132261|"     Dementia is a major cause of disabilities in older people. If the onset of dementia can be     delayed by preventive measures, the burden of the disease to the society can be greatly     reduced. It is now recognised that dietary factors are related to the incidence of dementia.     High intake of vegetables, fruit and fish are protective while high intake of saturated fat     and salt (via its effect on blood pressure) are detrimental to risk of dementia.      The investigators therefore propose to perform a randomized controlled trial of dietetic     interventions in old age hostels in Hong Kong. Twelve old age hostels under the Tung Wah     Group will be randomly assigned to intervention or control groups. The intervention group     will receive dietetic interventions by 2 weekly small group discussion with the residents,     modification of menu and publicity. The daily diet to be implemented consists of the     following principles: 1. fresh fruit 2 portions, 2. vegetables 4 portions, 3. fish, 4. white     meat, 5. sodium intake < 100 mmol/L, 6. six glasses of water. In the control group. The     dietician will give two health talks and advice on menu only.      The primary outcome is the incidence of questionable dementia in those who are normal at     baseline and the incidence of dementia in those who have questionable dementia at baseline.     The categorisation will be performed by trained research assistant after administering a     structured questionnaire. Change in mini-mental examination score and SF36 quality of life     scores are secondary outcomes. Food records over three days for each subject are recorded     every three months, to ensure that the brain preservation diet has been adhered to. Half of     the subjects will be randomly assigned to have blood and urine tests at baseline and at one     year, in order to examine the health effects of dieting.   "
250099|NCT01132274|"     Radiofrequency catheter ablation (RFCA) is the mainstay of therapy for supraventricular     tachyarrhythmias, providing cure in a high percentage of cases. Conventional ablation     techniques require the use of fluoroscopy to place and navigate catheters in the heart, thus     exposing patients to ionizing radiations with an additional risk of cancer. The feasibility     and safety of a non-fluoroscopic RFCA of a wide range of supraventricular arrhythmias using     the EnSite NavX mapping system have been recently reported. The NO-PARTY is a multicenter,     randomized-controlled trial designed to test the hypothesis that supraventricular arrhythmias     RFCA through the non-fluoroscopic EnSite NavX mapping system results in a clinically     significant reduction of the exposure to ionizing radiations compared with conventional     ablation techniques.      NO-PARTY trial will determine whether supraventricular tachyarrhythmia RFCA through a     non-fluoroscopic EnSite NavX mapping system is a suitable and cost-effective approach to     achieve a clinically significant reduction of ionizing radiation exposure for both the     patient and the operator.   "
250100|NCT01132287|"     Study to evaluate subjective comfort associated with the use of a marketed lubricant eye     drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily     disposable replacement schedule.   "
250101|NCT01132300|"     The purpose of this study is:        -  Initial evaluation of the clinical effectiveness of Image Guided Transcutaneous          Electrical Stimulation (TENS) device for treatment of non-specific low back pain.        -  To assess the tolerability and acceptability of the device by the caregiver (User          Friendly).        -  To evaluate patients' tolerance by monitoring side effects and tolerability during          treatment.   "
250102|NCT01132313|"     The substances BI 201335 and BI 207127 are being developed for the treatment of chronic     hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from     replicating.      The currently available medications pegylated interferon alfa and ribavirin for hepatitis C     ca have considerable adverse events in patients and in many cases are not sufficiently     effective. This is particularly the case in treatment of patients infected with genotype 1 of     HCV.      A combination therapy of these new substances without pegylated interferon alfa may be     associated with fewer adverse events that currently available (pegylated     interferon-alfa-based) medication and may also provide a treatment option to the large number     of patients with contraindications or intolerance to pegylated interferon alfa.      This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and     Part 3.      Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual     enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as     described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated:     362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83     patients randomized and treated)   "
250103|NCT01132326|"     Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of     norepinephrine depletion leading to a diminished capacity to effect an appropriate     cardiovascular response to an orthostatic challenge resulting in symptomatic     cerebral-hypoperfusion. Droxidopa augments norepinephrine levels which should lead to     improved cerebral perfusion following orthostatic challenge thereby reducing the symptoms of     NOH. The present study will evaluate the long-term safety of droxidopa.   "
250104|NCT01132339|"     Rationale:      Contrast agents are important tools for MR/CT- examinations, when it comes to diagnosing     diseases. But despite their frequent use in Denmark, they are not free of serious and     potentially fatal adverse reactions. Examples of this are contrast-induced nephropathy (CIN)     and nephrogenic systemic fibrosis (NSF). Therefore, it is extremely important to clarify if     these adverse reactions are actually directly related to the use of contrast agents or to     MR/CT- examinations.      Objective:      To prospectively assess the incidence of adverse reactions of iodine-containing CT and     gadolinium- based MR contrast agents in a prospective design. A control group examined     without the use of contrast agent will be included, so that the study can illuminate reported     adverse events related to contrast agents and CT/MR- examinations. This project will in the     long term mean that, any significant and life-threatening delayed adverse reactions will be     discovered earlier and hence it will be more likely to treat the patients in good time for     these adverse reactions.      The following series of hypotheses will be investigated in this study:        1. Renal as well as non-renal adverse reactions occurring are related to the use of          contrast agent in MR-/CT-examination.        2. CIN occurs in patients undergoing a MR-/CT-examination with contrast agent.      Methods:      Approvals are obtained from The Copenhagen County Committee on Biomedical Research Ethics and     Danish Data Protection Agency. A total of 1600 patients will be included from Department of     Radiology at Herlev Hospital, where all the MR- and CT examinations will be performed.     Patients will be divided into four groups (a, b, c and d) with 400 patients in each group.     Group a and c (case group) undergo respectively MR and CT examination with contrast agent     While group b and d (control group) will undergo respectively MR and CT examination without     the use of contrast agent. For each patient the following will be recorded: Risk factors,     renal function (eGFR) before and 72 hours after MR/CT- examination as well as the incidence     of immediate reactions (within 30 min.). Furthermore, patients have to answer a questionnaire     72 hours and 1 month after MR/CT- examination about the severity and frequency of adverse     reactions to contrast media.   "
250105|NCT01132352|"     The purpose of this study is to compare the single-dose relative bioavailability study of     Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under fed conditions.   "
250192|NCT01124747|"     The objective of this study is to assess the systemic disposition of ASP1585 after oral     administration of 14C-labeled drug in healthy male subjects.   "
250108|NCT01132391|"     Perianal topical nitroglycerin has been widely used as a means for avoiding surgery in     patients with anal fissure. However, nitroglycerin has not been universally accepted for this     application because of inconsistency of efficacy and side effects. Recent studies (Dis Colon     Rectum. 2007 Apr;50(4):509-16) have demonstrated that nitroglycerin ointment products     compounded by pharmacies did not meet the USP specifications for potency and/or content     uniformity when filling a prescription for 0.3 percent nitroglycerin ointment. These results     raise significant issues as to whether the patient is put at undue risk relative to the     relief of their anal fissure pain. In addition, one study (Dis Colon Rectum. 2006     Jun;49(6):865-8) has demonstrated that intra-anal dosing of topical nitroglycerin produces a     significantly greater reduction in sphincteric pressure and lower incidence of headaches than     with perianal administration of the same dose of ointment.      Topical glyceryl trinitrate 0.4% ointment has been developed and tested in clinical trials     and is effective in healing chronic anal fissures. It assures exactly dose and concentration     of nitroglycerin.      Hypothesis: The endoanal application of exactly dose and concentration of nitroglycerin must     reduced headache and the final recurrence.      The purpose of this study is:      1. Principal end-point: to compare perianal vs endoanal application of Rectogesic and     evaluate the different morbidity of the two presentation   "
250109|NCT01132404|"     The phase 1 portion of this study is an open-label, multicenter, dose-escalation study of     1-month depot TAK-448 in adult males with prostate cancer who are either on gonadotropin     releasing hormone (GnRH) therapy or who might be eligible for GnRH therapy in the future. The     phase 2 portion of this study is an open-label, multicenter, randomized study in men with     prostate cancer that will confirm the testosterone- and prostate specific antigen (PSA)-     lowering potential of up to 2 dose levels of 1-month depot TAK-448.   "
250110|NCT01132417|"     Observational: studies in human beings in which biomedical and/or health outcomes are     assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic,     therapeutic, or other interventions, but the investigator does not assign specific     interventions to the subjects of the study.   "
250111|NCT01132430|"     The high burden of asthma appears to be related to poor asthma control, which is associated     with more frequent asthma symptoms, greater bronchodilator use and functional impairment, and     worse pulmonary function. Despite the availability of effective treatments, more than 58% of     asthmatics are poorly controlled. Daily adherence to inhaled corticosteroid (ICS) regimens is     considered by experts to be one of the most important behavioral factors linked to achieving     optimal asthma control. However, there is a paucity of research on interventions specifically     designed to improve ICS adherence among adult asthmatics. The vast majority of intervention     studies to date used atheoretical interventions to target behavior change, relying mainly     upon educational approaches which have been criticised for failing to translate knowledge     into action. This may be due to the fact that most education-based approaches do not     specifically address or help patients overcome ambivalence about behavior change, which is     necessary for ensuring daily adherence. Motivational interviewing (MI) is a client-centred     intervention that focuses on enhancing intrinsic motivation to change a particular behavior,     and exploring and resolving ambivalence about behavior change. Brief MI sessions (e.g., 1-5 x     15-30 minute sessions) have been shown to improve a variety of health behaviors (e.g., reduce     alcohol consumption, improve dietary habits, increase exercise behaviour, and improve     medication adherence) and health outcomes (reduce blood pressure, body mass index, and     cholesterol levels). However, no studies to date have assessed the efficacy of using MI to     improve ICS adherence in asthmatics. This study aims to assess the efficacy of using MI to     improve daily medication (ICS) adherence in a sample of poorly controlled, non-adherent     asthmatics. It is hypothesized that patients randomized to the MI condition will exhibit     significantly improved ICS adherence at 6 and 12-months post-intervention, independent of     baseline levels and covariates, relative to patients randomized to the usual care control     condition.   "
250112|NCT01132443|"     This study was conducted to determine if the bioavailability of clindamycin and its     metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of     methylparaben. This study compared the investigational study product and 2 marketed products:        -  CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free        -  Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP)        -  Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)   "
250113|NCT01132456|"     The purpose of this study is to document the safety and overall clinical performance of the     Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a patient population with long     lesion(s) and/or dual vessels requiring stent implantation.   "
250114|NCT01132469|"     The purpose of this study is to evaluate the safety and clinical effectiveness of     ESD(Endoscopic Submucosal Dissection) for early gastric cancer analyzing short-term and     long-term results of endoscopic treatment.   "
250116|NCT01132495|"     The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and     cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in     patients with stable coronary artery disease.   "
250117|NCT01132508|"     Case series of tibial plateau fractures using Norian Drillable.   "
250118|NCT01132521|"     This study aims to evaluate the effect of ulinastatin in the treatment and prevention of     organ failure in severe acute pancreatitis.   "
250193|NCT01124760|"     The aim of this study is to examine the effect of coadministration of CYP3A4 inhibitors on     the pharmacokinetics of AZD9742.   "
250119|NCT01132534|"     Videoendoscopy is the standard tool for examination of gastrointestinal tract. However,     precancerous lesions and early gastric cancer can be easily missed by routine videoendoscopy.     Autofluorescence Imaging (AFI) and Narrow band imaging (NBI) are 2 new imaging systems used     in endoscopy which are recently developed. AFI based on the presence of natural tissue     fluorescence on the gastrointestinal tract. By computation of the difference in the     reflecting images, the system can reveal early cancers that are not detectable by standard     endoscopy. NBI is a high resolution imaging using lights with narrowed wavelength range,     which able to enhance the fine structure of the mucosa. Recent studies suggested combined AFI     and NBI can improve the detection of early esophageal and gastric cancers.      The investigators are conducting a prospective randomized cross-over study to compare the     accuracy between this combined AFI/NBI imaging with standard videoendoscopy in the detection     of precancerous lesions and gastric cancer in a high risk population inSingapore. The     investigators hypothesis is that this new combined imaging system improves the investigators     detection of high risk lesions of stomach.   "
250120|NCT01132547|"     RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer     treatment. It is not yet known whether cyproheptadine is more effective than a placebo in     preventing weight loss in young patients receiving chemotherapy for cancer.      PURPOSE: This randomized phase III trial is studying cyproheptadine hydrochloride to see how     well it works in preventing weight loss in young patients receiving chemotherapy for cancer.   "
250121|NCT01132560|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research study is studying biomarkers in tissue samples from patients with     ductal breast carcinoma in situ.   "
250122|NCT01132573|"     This phase I trial studies the side effects and best dose of entinostat when given together     with clofarabine in treating patients with newly diagnosed, relapsed, or refractory poor-risk     acute lymphoblastic leukemia or bilineage/biphenotypic leukemia. Entinostat may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Giving entinostat with     clofarabine may kill more cancer cells.   "
250123|NCT01132586|"     This phase I trial studies the side effects and best dose of lenalidomide when given together     with cytarabine and idarubicin in treating patients with acute myeloid leukemia. Biological     therapies, such as lenalidomide, may stimulate the immune system in different ways and stop     cancer cells from growing. Drugs used in chemotherapy, such as cytarabine and idarubicin,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving lenalidomide together with cytarabine and idarubicin may     kill more cancer cells.   "
250124|NCT01132599|"     RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) and computed     tomography (CT) imaging, may help find and diagnose metastatic prostate cancer.      PURPOSE: This phase II trial is studying the side effects of C-11 choline and     18F-fluoromethylcholine and to see how well they work when used in PET and CT imaging in     patients with metastatic prostate cancer.   "
250125|NCT01132612|"     The purpose of this study is to provide long term clinical data for the compound for the     treatment of the indication of moderate to severe chronic plaque-type psoriasis.   "
250126|NCT01132625|"     This study will characterize the safety, tolerability, efficacy, pharmacokinetics, and     pharmacodynamics of AUY922 in adult patients with advanced solid malignancies in Japan.   "
250127|NCT01132638|"     The aim of this trial is to evaluate the complete remission of erosive gastroesophageal     reflux disease with pantoprazole magnesium 40 mg once daily versus esomeprazole 40 mg once     daily during four-week treatment with an extension treatment for non-responding patients. The     study includes a baseline period up to 14 days and a treatment period of either 4 weeks (28     -2 + 5 days), or 8 weeks depending on the cure of esophagitis due to gastroesophageal reflux.     The study will provide further data on safety and tolerability of pantoprazole magnesium.   "
250128|NCT01132651|"     The purpose of this study is to see if using a cooling pillow at night will help sleep     quality in people with atopic dermatitis (AD).   "
250129|NCT01132664|"     This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in     patients with relapsing HER2 overexpressing breast cancer who have previously failed     trastuzumab.      The study will further assess the safety and preliminary efficacy of BKM120 in combination     with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast     cancer and brain metastases (BM) who have previously failed trastuzumab.   "
250130|NCT01132677|"     Do differences exist between patients who receive a single intra-articular injection of     corticosteroid versus patients who receive a single intra-articular injection of hyaluronic     acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post     injection?   "
250131|NCT01132690|"     This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase     alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly assigned to     treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an intravenous (IV)     infusion of taliglucerase alfa every two weeks. The total duration of treatment will be 12     months. At the end of the 12-month treatment period eligible subjects will be offered     enrollment in an open-label extension study if taliglucerase alfa is not commercially     available.   "
250132|NCT01132703|"     The primary objective of this study is to evaluate the safety and tolerability of RP-1127     (glyburide for injection), administered as a bolus dose followed by a 3 day continuous     infusion. The secondary objectives are to assess the pharmacokinetics of RP-1127 and blood     glucose and serum insulin PD responses to RP-1127.   "
250133|NCT01132716|"     The objective of this study was to prove the bioequivalence of Valacyclovir     Hydrochlorothiazide Caplet under fed conditions.   "
250134|NCT01132729|"     The objective of this study was to prove the bioequivalence of Valacyclovir     Hydrochlorothiazide Caplet under fasting conditions.   "
250194|NCT01124773|"     WHIMS-Y provides valuable information on the long-term effects on risk of cognitive     impairment of hormone therapy in a subset of WHI participants in the WHI Hormone Trials.     Following cessation of study-prescribed HT cognitive function and impairment were assessed.   "
250135|NCT01132742|"     Malnutrition in children has even more severe consequences on disease course and long-term     health than malnutrition in adults. According to prior studies, malnutrition affects about     15-30 % of hospitalized children in Europe (ESPGHAN 2005, Pawellek et al 2008, Joosten and     Hulst 2008). However, available criteria for defining malnutrition in paediatric patients are     inconsistent, not based on firm evidence, and not generally agreed upon. Current guidelines     do not address assessment of and screening for childhood malnutrition. Therefore, a large     number of affected children are not adequately diagnosed.      One aim of this study is to assess the prevalence of malnutrition and patients at risk for     malnutrition among at least 2700 hospitalized children mainly across Europe. In addition     criteria to link anthropometric measurements and the prediction of outcome, i.e. length of     hospital stay, shall be established. A further goal then is to establish agreed,     evidence-based criteria for malnutrition in children with the purpose of leading to an     agreed, evidence-based screening tool for paediatric malnutrition in developed countries.     This tool shall include a set of simple questions, based on previously suggested tools.     Thereby this study will provide a strong basis for implementing evidence-based nutritional     interventions in paediatric patients by harmonisation of diagnostic criteria for childhood     malnutrition in developed countries.   "
250951|NCT01140555|"     This pilot study has a sequential design involving three groups to ensure appropriate     development and evaluation of the optimal procedural steps of the D-UAO device and to confirm     that those steps are reproducible in the hands of multiple surgeons.   "
250136|NCT01132755|"     This study is being done to develop a new method that can rapidly stage patients with gastric     and pancreas cancer. Staging means finding out what is the extent of the cancer in a     patient's body.      Currently before patients have the surgery to remove their cancer, a surgical exam is done in     the operating room to see if their cancer has spread. A thin tube-like instrument with lens     and a light is placed into the abdomen. This is done by making small cuts into the body. This     exam is called a diagnostic laparoscopy. If cancer spread is not seen, fluid is put into the     abdomen and then taken out. This is called lavage or washing. The fluid is then looked at     in a laboratory. If the fluid contains cancer cells surgery is often delayed.      The investigators are testing a new method to put the fluid into the abdomen. It is called     percutaneous lavage. Percutaneous means through the skin. A needle is put through the skin     into the abdomen. Tubing is then placed over the needle so that fluid can be put into the     abdomen and then taken out. The fluid is then looked at in a laboratory. The investigators     want to see if the two methods are equal because if they are equal, in the future, patients     may be able to have this procedure done outside of the operating room.   "
250137|NCT01132768|"     Effect of olmesartan medoxomil (20-40 mg) on plaque regression in hypertensive patients with     carotid atherosclerosis.   "
250138|NCT01132781|"     Allergic rhinitis and asthma are common respiratory diseases, which often coexist. The     prevalence of allergic rhinitis in subjects with asthma is up to 80%, and the prevalence of     asthma is 3-5 times greater in subjects with rhinitis than healthy controls. The mechanisms     of the allergen response in both diseases are parallel to each other, with similar mediator     and cellular responses to similar allergens. These observations have led to the suggestion     that both diseases are different expressions of one airway disease.We wish to evaluate the     effect of low dose theophylline in patients with asthma, given its effects as subtherapeutic     concentrations and the propensity to develop adverse events at higher doses.   "
250139|NCT01132794|"     Dental procedures such as wisdom tooth removal evoke very high levels of patients' anxiety     and it is, therefore, common practice to provide concomitant pharmacologic sedation.      Sedative agents can be administered by the oral, rectal, intra muscular and intravenous     routes. The oldest, safest and most convenient route at present is the oral route. However,     as Uygur-Bayramicli et al. mentioned that administering the drugs orally can result in     problems like delayed effect. Intranasal administration is a straightforward procedure. It is     simple and relatively painless. Although it may be objectionable, less patient cooperation is     required than with oral administration, especially in which the child must swallow the     medication.      Many studies on dental sedation have been carried out by anesthesiologists but there is no     ideal drug that can offer effects of both sedation and analgesia. Some drugs offer only one     effect and others are not safe enough for clinical use. Midazolam, a benzodiazepine drug, is     the traditional choice for sedation, but it has properties such as relatively slow onset and     no analgesia. Propofol is an alkylphenol sedative and hypnotic agent with a rapid onset and     offset. It has been used in patient controlled sedation before. But it has no analgesic     properties. It can provide some antegrade amnesia, but it is not as reliable an amnestic as     the benzodiazepine drugs. Because of these characteristics, propofol often is supplemented     with narcotics and benzodiazepines. Although not irritant, it can cause pain during     intravenous infusion.      A new drug, an alpha agonist with its relatively high ratio of α2/α1-activity (1620:1 as     compared with 220:1 for clonidine) of theα2 receptor is dexmedetomidine. This property may     lead to more potent effects of both sedation and analgesia without unwanted cardiovascular     effects fromα1 receptor activation. Most of the data evaluating the use of dexmedetomidine in     the intensive care unit (ICU) were obtained in the immediate postoperative period, mainly in     patients who underwent open-heart surgery. Currently, clinicians are awaiting studies in     broader patient populations. In the studies that have been completed to date, sedation has     been attained easily with maintenance of respiratory function. Patients are readily     arousable. There is a minimal increase in blood pressure initially, followed by a slight     decrease in blood pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow     rate of administration tend to decrease these circulatory side effects. So many clinical     studies have shown that it can be well and safely used intravenously, intramuscularly and     transdermally. Although not an officially technique, there are also reports of intranasal     administration resulting in fairly predictable onset in both adults and children.      The investigators propose that intranasal can help to improve postoperative pain relief with     better sedation.   "
250140|NCT01132807|"     This phase II trial studies how well chemotherapy based on positron emission tomography (PET)     scan works in treating patients with stage I or stage II Hodgkin lymphoma. Drugs used in     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)     may kill more cancer cells. Radiation therapy uses high energy x-rays to kill cancer cells.     Giving combination chemotherapy together with radiation therapy may kill more cancer cells     and allow doctors to save the part of the body where the cancer started. Comparing results of     diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help     doctors predict a patient's response to treatment and help plan the best treatment.   "
250141|NCT01132820|"     This phase II trial studies the side effects and how well cediranib maleate works in treating     patients with endometrial cancer that has failed to respond to initial chemotherapy or has     come back after surgery, radiation therapy, or other forms of treatment. Cediranib maleate     may stop the growth of tumor cells by blocking proteins made by tumors that can stimulate     growth of tumor cells as well as blood vessels in and around tumors.   "
250142|NCT01132833|"     RATIONALE: Studying samples of blood in the laboratory from patients receiving chemotherapy     may help doctors learn more about the effects of chemotherapy on cells. It may also help     doctors understand how patients respond to treatment.      PURPOSE: This research study is studying biomarkers related to thrombosis in patients with     newly diagnosed multiple myeloma receiving chemotherapy.   "
250143|NCT01132846|"     The purpose of this study is to determine the benefits and safety of intravenous     administration of low dose nesiritide or low dose dopamine in patients with congestive heart     failure and kidney dysfunction. There is a substudy in a subset of subjects that is being     used to determine whether the Provocative Dyspnea Severity Score (pDSS) is a more sensitive     index of variability in clinical status than the dyspnea VAS assessed without standardization     of conditions at assessments.   "
250157|NCT01133028|"     Children with Attention-Deficit/Hyperactivity Disorder (ADHD) comprise about 5-10% of the     elementary school-age population. One place where children with ADHD have great difficulty is     in being accepted by peers and in making friends. It has unfortunately been very difficult     for the field to find good treatments for peer relationship problems for this population.     Even when children with ADHD do improve their behavior, it is common that peers do not seem     to like the child with ADHD any better. This may happen because children often have negative     reputations with their classmates that are hard to change. That is, once a class of children     get the impression that one child is disliked or the social outcast, even if that child's     ADHD symptoms get better, the peer group may not notice any of these improvements. It is     hypothesized that the elementary school teacher may be able to help peers notice positive     behavior changes in children with ADHD when they do occur. This clinical trial will design     and pilot-test an intervention that would train teachers in classroom practices to reduce the     peer rejection of students with ADHD. The pilot test will be conducted in a summer program     created to be similar to a regular school classroom in structure. If the treatment seems to     succeed in the summer program, then it will be tried in regular classrooms in a future study.   "
250149|NCT01132924|"     Background:      - The purpose of the 1982 1986 North Carolina Early Pregnancy Study was to determine how     often pregnancy loss occurs before women know they are pregnant. Women planning to become     pregnant were asked to collect daily urine specimens and fill out daily diaries of their     intercourse and menstrual bleeding. Researchers are interested in re-contacting this cohort     to gather new information and to examine how accurately women can recall events that occurred     earlier in their lives.      Objectives:      - To follow-up with and gather additional information from women who were involved in the     Early Pregnancy Study.      Eligibility:      - Women who participated in the 1982 1986 North Carolina Early Pregnancy Study.      Design:        -  Participants will receive and complete a questionnaire that includes the following          topics:        -  Their pregnancy history.        -  The infant s birth, including method of delivery and induction of labor.        -  Early life exposures such as their own birth weight and their parents ages at their          birth.        -  Tap water use during their attempt to conceive        -  General description of their behaviors during their participation in the original study,          these include: physical activity, caffeine, alcohol, and soy food consumption.        -  Participants will return the surveys to the researchers in the stamped envelope provided          with the questionnaire.   "
250144|NCT01132859|"     Background:      - The Vaccine Research Center (VRC) is dedicated to understanding immune responses associated     with prevention and treatment of infectious diseases. To study these immune responses,     researchers need to collect specimens and images from individuals who have recently had a     vaccination or recovered from an infection. These specimens and images are used to study     different diseases and immune responses, and can be used to investigate ways to prevent or     treat different medical conditions.      Objectives:      - To evaluate blood and other tissue samples for immune responses to vaccines and natural     infections.      Eligibility:      - Healthy volunteers at least 18 years of age who agree to donate specimens for research     purposes.      Design:        -  Participants will have clinical evaluations and will be asked to provide some of the          following samples, depending on the research question being addressed. All procedures          and sample donations are optional and voluntary:        -  Blood samples through regular blood draws (for whole blood) and apheresis (to collect          specific parts of the blood such as plasma or white blood cells)        -  Urine, semen, saliva, or vaginal swab samples        -  Tissue samples or biopsy specimens        -  Undergo procedures such as bronchoscopy (lung and respiratory tract), gastrointestinal          endoscopy (stomach and upper intestinal tract), or colonoscopy (lower intestinal tract)          to obtain tissue samples        -  Undergo imaging studies such as positron emission tomography (PET) or computed          tomography (CT) scans      Duration of participation is variable depending on the research question but will usually     last up to 1 year.      - Participants will be compensated for participation.   "
250145|NCT01132872|"     Background:        -  Researchers studying new treatments for major depressive disorder are looking at how          medications to treat depression act on the brain chemical serotonin, which interacts          with specific serotonin receptors on brain cells. New methods of studying serotonin          receptors in the brain may help provide a better understanding of depression and          treatment options.        -  A new radioactive chemical called [11C]CUMI may be useful for studying serotonin          receptors in the brain. By using positron emission tomography (PET) scanning to see how          [11C]CUMI bonds with serotonin receptors, researchers will investigate whether [11C]CUMI          can be used to study depression and how antidepressant medications work.      Objectives:      - To determine the usefulness of [11C]CUMI as a method of studying serotonin receptors in the     brain.      Eligibility:      - Healthy individuals between 18 and 65 who have no history of psychiatric illness.      Design:        -  This study requires 8 outpatient visits to the NIH clinic.        -  Visit 1: Participants will have a full physical examination and medical history, as well          as a psychiatric evaluation and questions about alcohol and drug use. Other tests will          include blood and urine samples and an electrocardiogram (EKG). Testing will take          approximately 3 hours.        -  Visit 2: Participants will have a magnetic resonance imaging (MRI) scan to evaluate          brain function and activity.        -  Visit 3: Participants will have a PET scan, in which a small amount of the radioactive          chemical [11C]CUMI will be injected through an intravenous (IV) catheter, and will have          another IV line put in place to draw regular blood samples during the scan. The scan          will last approximately 4 hours.        -  Visits 4-8: Participants will have regular blood tests after the scan between days 1-3          and at about weeks 1, 2, 3, and 4. The blood tests will check muscle, heart, and liver          function.   "
250146|NCT01132885|"     Background:      - Little is known about how the brain changes during childhood and adolescence, how genes     affect this process, or how the brains of people with Williams syndrome change during this     period. Genetic features of Williams syndrome affect the brain s development, but the details     of this process have not been studied over time. Researchers are interested in using magnetic     resonance imaging to study how the brain changes in healthy children and children with     Williams syndrome and related genetic disorders.      Objectives:      - To study developmental changes in the brains of healthy children and children who have been     diagnosed with Williams syndrome or a related genetic disorder.      Eligibility:        -  Healthy children and adolescents between 5 and 17 years of age.        -  Children and adolescents between 5 and 17 years of age who have been diagnosed with          Williams syndrome or genetic characteristics that overlap with Williams syndrome.      Design:        -  Participants will have a brief physical examination and tests of memory, attention,          concentration, and thinking. Parents will be asked about their child s personality,          behavior characteristics, and social interaction and communication skills.        -  Both participants and their parents may be asked to complete additional questionnaires          or take various tests as required for the study.        -  Participants will have approximately 10 hours of magnetic resonance imaging (MRI)          scanning, usually over 4 to 5 days, within a one month period. Some of these tests will          require the participants to do specific tasks while inside the MRI scanner.        -  Participants will be asked to return to the National Institutes of Health clinical          center to repeat these procedures every 2 years thereafter until age 18.   "
250147|NCT01132898|"     Background:      - Traumatic brain injury may have a range of effects, from severe and permanent disability to     more subtle functional and cognitive deficits that often go undetected during initial     treatment. To improve treatments and therapies and to provide a uniform quality of care,     researchers are interested in developing more standardized criteria for diagnosing and     classifying different types of traumatic brain injury. By identifying imaging and other     indicators immediately after the injury and during the initial treatment phrase, researchers     hope to better understand the nature and effects of acute traumatic brain injury.      Objectives:      - To study the natural history of traumatic brain injury by examining the changes in brain     scans, blood samples, and brain function over 5 years after a the injury.      Eligibility:      - Individuals between 18 and 70 years of age who have had a traumatic brain injury within the     past 6 months.      Design:        -  This study will include about eight visits to the NIH Clinical Center over 5 years.          Participants will have four visits in the first year, and one visit each year for the          following 4 years. Each visit will take between 1 and 4 days, and participants will be          in the outpatient clinic for about 8 hours each day of the visit.        -  At each study visit, participants will have some or all of the following tests:        -  Medical history and physical examination        -  Blood and urine tests        -  Questionnaires and assessments of thinking and memory, which may be spoken aloud,          written down, or entered into a computer        -  Imaging scans, such as magnetic resonance imaging (MRI) or positron emission          tomography/computed tomography (PET/CT).        -  This study does not provide treatment and does not replace any current therapies.          However, participants who are eligible for other National Institutes of Health studies          may be referred to these studies by researchers.   "
250148|NCT01132911|"     Background:      - Vorinostat and bortezomib are anti-tumor drugs that have been approved by the Food and Drug     Administration to treat different kinds of myeloma and lymphoma in adults. The combination of     these two drugs has been tried in a small number of adults, but it has not been formally     approved and is experimental, particularly in children. Researchers are interested in     determining safe and effective treatment doses of vorinostat and bortezomib in children, and     learning more about how these drugs affect tumor growth and human development.      Objectives:        -  To determine safe and effective doses of vorinostat and bortezomib to treat solid tumors          in children.        -  To study the effects of vorinostat and bortezomib on blood cells, blood flow, and human          development.      Eligibility:      - Children, adolescents, and young adults between 1 and 21 years of age who have been     diagnosed with solid tumors that have not responded to treatment.      Design:        -  Eligible participants will be screened with a physical examination, blood and tumor          samples, and imaging studies.        -  Participants will have 21-day treatment cycles of vorinostat and bortezomib. Vorinostat          will be given as either tablets or liquid doses on days 1 through 5 and 8 through 12 of          each cycle. Bortezomib will be given as an intravenous injection on days 1, 4, 8, and 11          of each cycle. Participants will keep a drug administration diary to record information          about side effects or other problems with the treatment.        -  Participants may continue to receive vorinostat and bortezomib for up to 2 years unless          serious side effects develop or the tumor does not respond to treatment.        -  Additional blood samples will be taken at regular intervals for the first 3 days after          the first bortezomib dose and for the first 2 days after the first vorinostat dose of          the first treatment cycle.   "
250214|NCT01125033|"     The purpose of this study is to determine whether vitamin C, vitamin E and their combination     are effective in the treatment of RLS in hemodialysis patients.   "
250150|NCT01132937|"     Background:      - Traumatic brain injury may have a range of effects, from severe and permanent disability to     more subtle functional and cognitive deficits that often go undetected during initial     treatment. To improve treatments and therapies and to provide a uniform quality of care,     researchers are interested in developing more standardized criteria for diagnosing and     classifying different types of traumatic brain injury. By identifying imaging and other     indicators immediately after the injury and during the initial treatment phrase, researchers     hope to better understand the nature and effects of acute traumatic brain injury.      Objectives:        -  To study the MRI results of individuals who have recently had head injury and suspected          traumatic brain injury.        -  To study the natural evolution of traumatic brain injury for up to 3 months after head          injury.      Eligibility:      - Individuals at least 18 years of age who have been admitted to a hospital with a diagnosed     or suspected traumatic brain injury within the past 48 hours.      Design:        -  Participants will have one 3-hour study visits: an initial visit (within 48 hours of          head injury). Participants may be asked to have an optional 4-day, 30-day, 90-day, and          1-year follow-up.        -  Each visit may involve blood samples, an MRI scan (approximately 30 minutes), and a          series of tests to evaluate brain function.        -  At the optional follow-up visit, participants may have blood samples, an MRI scan, and a          general traumatic brain injury assessment.        -  This study does not provide treatment and does not replace any current therapies.          However, participants who are eligible for other National Institutes of Health studies          may be referred to these studies by researchers.   "
250151|NCT01132950|"     The purpose of this study is to increase the initiation and continuation of highly effective     contraceptive use while incarcerated and upon release, as well as decrease unsafe sexual     activity.   "
250152|NCT01132963|"     The study aims to assess whether type of footwear worn changes the balance, mobility and     confidence of older inpatients and consequently may affect their falls risk whilst in     hospital. The investigators hope to identify which footwear type is most beneficial to     patients in the ward environment.   "
250153|NCT01132976|"     Services for people with personality disorders are challenged by how to engage clients in     therapy. High non-completion rates have major cost-efficiency implications, but more worrying     is that drop-out may be associated with negative outcomes for clients. The investigators have     developed a motivational intervention that helps people focus on their valued and attainable     life goals and consider how therapy could help with goal attainment.One way to improve     retention in treatment is to deliver pre-therapy motivational preparation interviews. The     primary aim of our proposed research is to gather information to determine whether a     randomised controlled trial of a goal-based motivational intervention is feasible in a     community personality disorder treatment service.   "
250154|NCT01132989|"     Patients with cutaneous T cell lymphoma experience refractory and progressive disease despite     current treatment, necessitating chronic disease management. In addition, there needs to be     greater emphasis on combination treatment, which correlates with increased response rate,     more rapid onset of response, and decreased side effect profile compared to monotherapy. The     goal for the use of Lenalidomide as an adjuvant treatment in patients with refractory     cutaneous T cell lymphoma is to increase response rates, maintain a durable long-term     response, relieve associated symptoms, and minimize toxic side effects.   "
250155|NCT01133002|"     Primary Objective:      - To obtain prospective, clinical practice-based data on how symptomatic VTE is managed with     low molecular weight heparin (LMWH) enoxaparin in Canadian outpatient settings.      Secondary Objective:        -  To describe the demographic and clinical characteristics of patients with symptomatic          VTE including characteristics of VTE, VTE risk factors and bleeding risk factors.        -  To assess the frequency of patient characteristics that would necessitate adjustment in          the dose or duration of enoxaparin therapy, e.g. high BMI, impaired creatinine          clearance, advanced age, cancer-associated VTE.        -  To assess the degree of adherence in clinical practice to Consensus Guidelines          (ACCP/American College of chest Physician 2008) for the management of acute VTE, vis a          vis:        -  Appropriate dosing of enoxaparin        -  Recommended duration of initial LMWH therapy        -  Adequate overlap of LMWH with vitamin K antagonists (VKA)        -  Recommended duration of longterm VKA        -  Frequency of use of LMWH monotherapy to treat cancer-related VTE        -  To access safety outcomes (including bleeding and recurrent VTE)        -  To describe the utilization of resources due to bleeding and recurrent VTE during the          treatment period.   "
250156|NCT01133015|"     This study will evaluate the relationship of Fractional Flow Reserve (FFR) and Minimal Lumen     Area (MLA) by IntraVascular UltraSound (IVUS) by comparing the results of the both tests     which is done as a part of the cardiac catheterization.   "
250195|NCT01124786|"     The purpose of this study is to determine whether CO-1.01 is safe and effective in the     treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared     with gemcitabine.   "
250159|NCT01133054|"     The anomalous origin of right coronary artery (RCA) is a rare coronary anomaly. Recently, the     detection of this anomaly has been more frequent as the use of cardiac multidetector computed     tomography has become more popular. It can cause myocardial ischemia, syncope and sudden     cardiac death. Surgical repair is generally recommended for symptomatic patients. However,     there is controversy concerning the proper evaluation and treatment strategy for patients     without documented myocardial ischemia.      The stenotic lesion of anomalous origin of RCA will be assessed by fractional flow reserve     (FFR).   "
250160|NCT01133067|"     Does the routine clinical practice of follow up after primary treatment in lung cancer     patients has any utility.   "
250161|NCT01133080|"     Double - Blind, Randomized, single centered study. The purpose of this study is to assess the     feasibility of minocycline vs. placebo, added to atypical antipsychotic medications, for     positive symptoms in adults suffering from schizophrenia.   "
250162|NCT01133093|"     The purpose of this study is to assess the distribution, awareness and control of main     cardiovascular risk factors in the Spanish population. The main study variables are:        -  Lifestyles (tobacco, alcohol, nutrition, physical activity)        -  Biological risk factors either well-established (blood lipids, glucose, insulin and          blood pressure) or emergent (leptin, C-reactive protein and other markers of          inflammation)   "
250163|NCT01133106|"     The overall goal of this study is to conduct a three-armed randomized controlled trial (RCT)     in stroke survivors with depression to determine if a brief psychosocial-behavioral therapy     intervention delivered in-person (arm A) or by telephone (arm B) is better than usual care     (arm C), in terms of percent reduction in depressive symptoms and % of participants achieving     remission of symptoms.   "
250164|NCT01133119|"     In the Cardiac Diagnostic and Interventional Unit (CDIU) at the Hospital for Sick Children     (SickKids), minimally invasive procedures are performed to diagnose and treat a variety of     congenital heart defects. Procedures are performed under general anesthetic and involve     inserting a catheter through the skin and into the femoral vein or artery in the groin. In     addition, the use of local anesthetic as a pain control regimen just prior to the removal of     femoral artery or vein sheaths is used by some but not all cardiac interventionalists. Local     anesthetic is infiltrated near the sheath insertion site, at the end of the procedure while     the child is under general anesthetic, with the goal of decreasing pain at the insertion site     and promoting comfort in the post-operative period. The use of local anesthetic depends on     the choice of the individual practitioner and is not currently a routine practice for all     patients.      The investigators proposed research seeks to investigate whether the use of subcutaneous     bupivacaine reduces pain levels in the post-operative period in children having cardiac     catheterization procedures.   "
250165|NCT01133132|"     This study will develop and test the benefits of a new ICCS (Interactive Cancer Communication     System), a mobile Comprehensive Health Enhancement Support System (Survivorship CHESS) in     colon cancer survivors. Survivorship CHESS will provide information, tools, and a support     system based on our previous work with FRESH START and CHESS, two highly successful     interventions that have promoted lifestyle change among cancer patients and survivors.     Survivorship CHESS will be designed to help subjects develop 1) competence in information     gathering, decision-making, and behaviors they are trying to change, 2) social support     systems to help deal with the cancer experience, and 3) autonomy that comes with regaining a     sense of control over their lives; this in turn, will help them adopt or maintain healthy     lifestyle behaviors and improve their quality of life.   "
250166|NCT01133145|"     High energy trauma often results in severe soft tissue, bone and joint injury. Today, many     methods and techniques exist to treat theses severely injured extremities. Surgical     techniques include open reduction and internal fixation (ORIF), e.g. with screws and plates,     soft tissue reconstruction by local or free flaps and joint reconstruction by arthroplasty,     e.g. total knee arthroplasty. In few, very severe cases, those methods are not sufficient to     restore function and amputation is the only option left.      In 1908 the German surgeon Erich Lexer had the idea to transplant a joint. Due to the medical     situation at his time the attempts failed.      But the idea survived and was processed over the time. Transplant surgery and medicine     developed, immunosuppressive drugs were established and animal models proved that bone and     joint transplantation is technically feasible.      In 1998 the first successful hand and in 2005 the first partial face transplantation was     carried out. In 1996 we started our clinical femur and knee joint transplantation project.   "
250167|NCT01133158|"     Assess the combination of efficacy of the combination of rituximab, bendamustine,     mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.   "
250168|NCT01133171|"     Personalized risk communication methods have been used to educate patients that are at a high     risk of developing cardiovascular disease. These methods include personalized counseling,     printed brochures and individualized graphs describing the status of the risk factors. Very     few studies have provided an interactive tool for patients to self-manage their risk factors     and observe the changes in risk by making lifestyle changes and modifying other risk factors     by seeking medical advice.      This Rapid Response Project (RRP) builds upon these methods of communication by presenting     the modifiable risk factors in the form of a personalized dashboard that highlights the     contribution of these risk factors on the risk of developing a cardiovascular event. The     modifiable risk factors that will be addressed in this study will include medical and     lifestyle risk factors. The medical risk factors are hypertension, atrial fibrillation,     diabetes mellitus and hyperlipidemia whereas the lifestyle risk factor is tobacco use.      Our primary goal is to develop a prototype of the dashboard to educate patients and help them     make informed decisions in modifying their risk factors to reduce the probability of a     cardiovascular event or stroke. We will also evaluate the effectiveness of this tool by     asking these patients to return after 6 months to determine if they have made any lifestyle     changes or pursued medical intervention to reduce their cardiovascular risk. We will make     qualitative observations on the knowledge retention of these patients while using the     interactive dashboard.   "
250261|NCT01125644|"     Recruitment of at least 10 adult patients (men and women) among individuals affected and     admitted to the hospitals identified for the clinical study. All patients shall be between 18     and 75 years of age, with confirmed diagnosis of cryptococcosis or aspergillosis . During     therapy (14 days) and examination (28 days), the patients will be subject to 7 doctor's     visits (day 1,3,7,10,14,21, and 28).   "
250169|NCT01133184|"     Impaired activity of Natural Killer (NK) cells has been proposed as a mechanism contributing     to viral persistence in Hepatitis C Virus (HCV) infection. NK cells display anti-fibrotic     activities by killing activated hepatic stellate cells (HSCs) that have lost the     self-recognition marker; Major Histocompatibility (MHC) class I. Determining the     down-expressed genes on NK cells necessary for their anti-fibrotic activity was never studied     previously. This will allow us to study their role fully in phagocytosis process as well as     their interaction of HSCs and therefore manipulating these genes using molecular techniques.     Exploring the cellular functions of these genes will highlight their involvement in the     progression of liver fibrosis and could be used as a therapeutic tool for preventing the     disease.   "
250170|NCT01133197|"     This study is designed to define the impact of thumb arthritis on patient's general health.     As a secondary objective, data will be analyzed to determine the effects of medical and     musculoskeletal comorbidities on the rating of upper extremity function by the patient.   "
250171|NCT01133210|"     The purpose of this study is to determine the effect of maraviroc therapy in obese insulin     resistant subjects on:        1. Plasma triglyceride concentration        2. Plasma HDL-cholesterol and LDL-cholesterol concentrations        3. Plasma markers of cardiometabolic risk and inflammation   "
250172|NCT01124487|"     Objectives: To investigate the acute effects of olive oil, palm olein and lard on lipid     profile, insulin sensitivity and inflammatory markers.      Hypothesis: Different dietary fats will alter lipid profile, insulin sensitivity and     inflammatory markers postprandially.   "
250173|NCT01124500|"     The purpose of this study is to compare the effects, good and/or bad, of the Methylphenidate     patch and a placebo patch (a patch that contains no medicine) on patients and their fatigue     caused by cancer or by cancer treatment. The Methylphenidate patch contains a medication that     is known to increase alertness and wakefulness. Oral methylphenidate has been used in the     past to treat cancer related fatigue and is often used to treat unusual sleepiness. But this     is the first time that the patch form is offered to try treating cancer fatigue in patients     who cannot always swallow tablets.   "
250174|NCT01124513|"     The gold standard method of assessing skin pigmentation is spectrophotometry; however, even     as early as 1961 the potential for confounding by dilatation of blood vessels was recognized.     (Monash 1961) Manual compression was used to express the blood from the field being measured.     The red reflectance captured by reflectance spectrophotometer introduced an uncontrollable     variable when measuring the tanning /pigmentation response of skin tone/color. Room     temperature induced increased or decreased blood flow through the skin, which altered the     findings by spectrophotometer. Other potentially confounding variables that changed blood     flow were: recent exercise, and the flushing/blushing for emotional reasons. Since these     conditions were difficult to reliably control on the sun exposed extremities,     spectrophotometry was not a practical method to assess change in melanin over time as an     outcome measure for efficacy of sun protection.      Digital imaging with videodermatoscopy utilizing a portable device that is supported by a     laptop computer, provides a high resolution digital image for analysis. (EasyScan) As     described by Yamamoto et al (2008), applying the Image J freeware to quantify the     pigmentation in the digital image holds promise as a practical objective method to reliably     assess skin tones based on the melanin content in a non invasive manner. With     standardization, the software and hardware may quantify the constitutive pigment in the sun     protected skin as the melanin index.   "
250175|NCT01124526|"     The purpose of this study is to determine whether the rituximab administration with     fludarabine and cyclophosphamide results, are better, than the ones obtained with     conventional therapy such as CHOP (cyclophosphamide, adriamycin, vincristine, prednisone) and     also to determine whether the rituximab administration as maintenance treatment during two     years, increase the global clinical responses and the disease free time interval.   "
250176|NCT01124539|"     The primary objective of this study is to determine the 6-month Progression free survival     (PFS) when intravenous (IV) AR-67 is administered in adults with confirmed recurrence of GBM     who have not recently (> 90 days) recurred after treatment bevacizumab (including patients     who've received temazolamide, but no bevacizumab). The primary objective in the rapid     bevacizumab failure group (< 90 days) is to determine the 2-month PFS.   "
250177|NCT01124552|"     The purpose of this study is to find out if an investigational drug, called RT001 Topical     Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called     lateral canthal lines, also known as crow's feet wrinkles.   "
250178|NCT01124565|"     This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2)     sequential applications.   "
250179|NCT01124578|"     PURPOSE OF EVALUATION: This study will verify & validate the acceptability of Egret's     extended use product as compared to the existing daily change-out product. Based on an     extensive in-vitro study, Egret's product confirmed significant kill for both positive and     negative gram bacteria. In addition to meeting all of the current product requirements, total     aerobic bio-burden on the catheters will be tested at various intervals for up to 10 days of     use. The current used product will be used as a control group that is to be changed out daily     as per current policy. The control group will be tested for total aerobic bacteria counts on     the last day of use.   "
250196|NCT01124799|"     The purpose of the study is to evaluate the potential effect of TMC435 on the sensitivity of     the skin towards exposure to sunlight. TMC435 is a drug that is currently under development     for treatment of chronic hepatitis C virus infection. This study will be conducted in healthy     volunteers. Ciprofloxacin, a commonly used antibiotic, is used as a positive control as this     drug is known to mildly increase skin sensitivity to exposure to sunlight. This study also     evaluates the levels of TMC435 and ciprofloxacin in the blood circulation and the safety and     tolerability of TMC435.   "
250197|NCT01124812|"     The aim of this feasibility study is to determine the therapeutic potential of the L19SIP     antibody, labeled with the radionuclide 131I in combination with radiochemotherapy, for the     treatment of patients with newly diagnosed, unresectable, locally-advanced NSCLC following     the promising results with this agent in previous clinical studies.      The L19SIP antibody is a fully human antibody, capable of preferential localization around     tumor blood vessels while sparing normal tissues. The formation of new blood vessels is a     rare event in the adult (with the exception of the female reproductive tract), but it is a     characteristic pathological feature for most types of aggressive cancer.   "
250180|NCT01124591|"     Although screening, brief intervention, and referral to treatment (SBIRT) approaches are     effective in reducing alcohol misuse and its associated risk-taking behaviors and negative     consequences, there is little research demonstrating the effectiveness of SBIRT for illicit     and/or prescription drug misuse. Misusers of illicit and/or prescription drugs frequently     seek medical care in emergency departments (EDs), particularly for reasons related to their     misuse. As a result, the ED is well suited as a site to conduct an analysis of the     effectiveness of SBIRT for this population.      The Brief Intervention for Drug Misuse for the Emergency Department (BIDMED) study is a     randomized, controlled, trial that will include adult ED patients at a large, academic,     trauma center (Rhode Island Hospital) and a community hospital (The Miriam Hospital) who have     a subcritical illness or injury and whose screening indicates illicit and/or prescription     drug misuse. BIDMED participants will be randomized to receive screening only (SO) or brief     intervention (BI) with appropriate referral to treatment. Participants will complete a     battery of blinded baseline assessments using standardized instruments as well as adapted     instruments specific to the aims of this study. All participants will undergo blinded     follow-up assessments at three, six, and twelve months post-randomization. The primary     hypotheses addressed in the BIDMED study are that, compared to participants in the SO arm,     participants in the BI arm will show a significantly greater reduction in: (1) drug misuse     within the prior 30 days at three months post-randomization, (2) behaviors associated with     drug misuse at six months post-randomization; and (3) negative physical health, psychosocial     health, and socioeconomic consequences at twelve months post-randomization. As a secondary     aim, the impact of BI compared to SO will be assessed on participants contacting, enrolling     in, and completing a drug treatment program. In addition, the impact of BI compared to SO on     increasing uptake of HIV and hepatitis B/C screening will be measured. A mechanisms of change     model that addresses the expected mediators and moderators of change to explain the effects     of SBIRT in this setting will also be developed and tested. Further, the epidemiology of     illicit and/or prescription drug misuse will be assessed in a random sample of ED patients.   "
250181|NCT01124604|"     The purpose of this study is to evaluate the efficacy, safety and to explore the     pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the     body and how they are removed from the body over time) of tapentadol hydrochloride extended     release (ER) tablets in Japanese participants with moderate to severe chronic pain due to     osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back     pain.   "
250182|NCT01124617|"     The purpose of this study is to investigate the efficacy and safety of tapentadol     extended-release (ER) tablets in Japanese participants with moderate to severe chronic     (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the     extremities related to diabetes-induced nerve damage) or postherpetic neuralgia (pain lasting     after condition has healed).   "
250183|NCT01124630|"     Treatment with CS-1008 in combination with FOLFIRI (irinotecan, leucovorin, and     5-fluorouracil [5-FU]) in subjects with metastatic colorectal cancer (CRC) who have failed     first-line treatment that was not irinotecan-based.   "
250184|NCT01124643|"     This study will evaluate safety and clinical outcomes of treatment with Replagal in adult     participants with Fabry disease who have completed Study TKT028 (NCT00864851).   "
250185|NCT01124656|"     The purpose of this study is to determine the safety and tolerability of     pioglitazone-azilsartan, once daily (QD), in patients with type 2 diabetes mellitus.   "
250186|NCT01124669|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in blood samples from patients with     refractory non-small cell lung cancer previously treated with sorafenib tosylate.   "
250187|NCT01124682|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more     tumor cells and cause less damage to normal tissue.      PURPOSE: This phase I trial is studying the side effects and best dose of 3-dimensional     conformal radiation therapy in treating patients with bladder cancer who have undergone     transurethral resection of the bladder.   "
250188|NCT01124695|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells.      PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with     metastatic or recurrent breast cancer.   "
250189|NCT01124708|"     ADHD has been associated with persistent deficits in the efficient allocation of attention     and supports the notion that regulation of the cholinergic system may improve these cognitive     deficits in ADHD. It has been suggested that the effects of nicotine are most pronounced on     tasks that demand effortful processing (Rusted and Warburton 1994). In addition, a recent     theory proposes that the cholinergic system allocates additional attentional resources during     tasks that are demanding (i.e. sustained attention, set shifting, etc; Sarter and Bruno     1997). Thus it may be that in ADHD, cholinergic systems are under-responsive or     under-developed and thus stimulation of nicotinic receptors via nicotinic agents may result     in improved cognitive performance particularly on tests requiring effortful processing.   "
250190|NCT01124721|"     Impaired WM is a central deficit in ADHD. A computerized training program, Cogmed, has been     shown to increase WM capacity in children with ADHD. It is not known whether the training     improves behavior associated with classroom learning, such as remaining on-task and     inhibiting off- task behavior. The aim of this study is to utilize ecologically valid     measures to investigate training's effect on observable ADHD behavior in conjunction with     more standard measures. Subjects will be randomly assigned to a Cogmed versus an active     placebo condition in which the tasks do not increase in difficulty level in a     double-blinded fashion. The effects of the active Cogmed versus placebo computer training     will be compared on measures in children with ADHD.   "
250191|NCT01124734|"     The investigators have recently observed that many patients who had received high dose     Interleukin-2 (IL2) and failed to respond to it but who then go immediately to temozolomide     seemed to enjoy extremely good responses which seem better quality and longer duration than     typically observed for temozolomide alone. To date, the investigators have observed 5     sequentially treated patients with metastatic melanoma who had failed high dose IL-2 but who     then went on to receive immediate temozolomide. Two of these patients had complete responses     and 3 had very strong partial response. In a recent phase II study of extended low dose     temozolomide alone given in the same manner as the post IL-2 patients noted above, the     response rate was 12.5% and all of these were partial responses only. The responses that the     investigators observed were at a much higher rate of response as well as much better quality     than expected for temozolomide. The responses were also better than those observed when     temozolomide was given first and then followed by high dose IL-2. The investigators concluded     that perhaps the major benefit the investigators observed was a result of the prior high dose     IL-2 therapy modulated by the temozolomide and that the sequence of treatment was clearly     crucial for this response.   "
250262|NCT01125657|"     This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2     crossover method.   "
250201|NCT01124864|"     This study will assess the efficacy of AUY922, when administered weekly at 70 mg/m2, in adult     patients with advanced Non-small-cell Lung Cancer (NSCLC), who have received at least two     prior lines of chemotherapy. Patients will be retrospectively, and prospectively, stratified     based on their molecular tumor etiology. The following strata was assigned: Patients with     Epidermal growth factor receptor (EGFR) activating mutations, Patients with Kirstin Raus     sarcoma virus (KRAS) activating mutations, Patients with EML4-ALK (anaplastic lymphoma     kinase) translocations and patients that were both EGFR and Kras wild type.   "
250202|NCT01124877|"     The purpose of this study is to assess the safety and tolerability of ziprasidone during a     long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder     (Manic or Mixed).   "
250215|NCT01125046|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them.      PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with     recurrent or progression meningiomas.   "
250203|NCT01124890|"     SIAM III was a multicenter, randomized, prospective, controlled trial in patients with     ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms.     All patients received reteplase, aspirin in combination with ticlopidin, and heparin.     Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI.     The conservative group received elective PCI two weeks after fibrinolysis. In total 197     patients were included, 163 were treated by PCI. The primary end point was the composite of     ischemic events, death, reinfarction, and target lesion revascularization.   "
250204|NCT01124903|"     The sports medicine literature provides a consensus on what threshold values constitute     euhydration (normal body water) using a variety of hydration assessment markers (e.g., blood,     urine). The investigators add to this literature by providing decision levels for multiple     body fluids which can be used as starting points for diagnosing and treating dehydration. At     present, plasma osmolality (Posm) provides the best potential measure for static dehydration     assessment (spot measure), while dynamic dehydration assessment (serial monitoring) is best     accomplished using change values for Posm, urine specific gravity, or body mass (weight).     These findings should be considered useful for clinical, military, and sports medicine     communities.   "
250205|NCT01124916|"     The purpose of this research is to determine if there is a difference in total costs of care     and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC)     compared to those undergoing the same procedure with the assistance of a robot.      Both traditional laparoscopic and robotic assisted laparoscopic approaches have been found to     result in shorter hospital stays, decreased blood loss and similar surgical outcomes as     compared to open abdominal surgery. The decision to use robotic assistance is typically based     on surgeon preference and robot availability. The study will compare the outcomes of cost,     quality of life, and return to work among women who undergo a laparoscopic sacrocolpopexy     utilizing the robot to those using traditional laparoscopic techniques.      This research study is designed to compare the total costs and treatment success of these two     surgical techniques. In addition, the study will compare outcomes of post-operative pain,     quality of life, sexual function, return to normal activities and satisfaction with treatment     outcome.   "
250206|NCT01124929|"     Most of the guidelines on the treatment of tuberculosis suggest that 6 months treatment is     sufficient for extrapulmonary tuberculosis except for bone tuberculosis and tubercular     meningitis. Despite these recommendations, most physicians treating abdominal tuberculosis     use antituberculous therapy for 9 months, sometimes even 12 months without any scientific     justification. In a randomized controlled trial, Balasubramaniam et al reported no difference     in success rate of 6mo (99%) vs 12 months (94%) antituberculous drugs (conventional strategy)     in the treatment of abdominal tuberculosis.      Although Directly Observed Therapy (DOTs) have been proved to be effective in patients with     pulmonary tuberculosis, lymph nodal tuberculosis, however, there is a lack of data on     efficacy of DOTS in other extra-pulmonary disease including abdominal tuberculosis.     Therefore, there is an urgent need to establish the efficacy of DOTs strategy of     antituberculous therapy in the treatment of abdominal tuberculosis.      Therefore, the investigators planned to conduct a multicenter randomized controlled trial to     determine the difference in the recurrence of disease after only observation for three months     and three months extension of DOTs in a subset of patients with definite clinical response     after 6 months of DOTs.   "
250207|NCT01124942|"     The Investigators will test the hypothesis that MGuard net protective stent, the     investigational device, would be superior to conventional revascularization strategy (i.e.     bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent     percutaneous coronary interventions.   "
250208|NCT01124955|"     The aim of the present study is to assess the effectiveness of acupuncture using Yamamoto's     method for the treatment of ANLBP using the following outcomes:pain,functional     capacity,quality of life and number of 50 mg sodium diclofenac pills taken per day.   "
250209|NCT01124968|"     eConsulta is a before and after quasi-experimental study without control group and its     purpose is to asses the impact of virtual visits in primary care on the frequency of     attendance of the patients to the primary care centre. The use of virtual consultations     should lower the number of face to face visits to primary care. It also should create     satisfaction to both users: primary care professionals and patients.   "
250210|NCT01124981|"     Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy.     Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events     remains unknown.   "
250211|NCT01124994|"     The accurate detection and therapy of adenocarcinoma originating from Barrett's oesophagus is     challenging as current endoscopic techniques are unreliable for both the detection of high     grade intraepithelial neoplasia (HGIN) within Barrett's mucosa and the correct measurement of     the dimension of such neoplastic lesions. Confocal laser endomicroscopy (CLE) is a promising     technology that could help to close this gap. Relying on first clinical trials of CLE, which     showed remarkable results for the detection of Barrett's associated neoplasia, the     investigators want to use CLE as targeting tool for endoscopic mucosal resection of HGIN in     patients suffering from Barrett's oesophagus. CLE-mapping of neoplastic lesions will be     documented and compared to the later performed histological evaluation of the resected     specimen. If CLE is passing our challenge this will be another valuable proof of its high     potential as reliable new endoscopic technology. Its usage could increase the en-bloc     resection rate and decrease the amount of repetitive resections, which would remarkably     improve the patients comfort.   "
250263|NCT01125670|"     This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy make     adult subjects.   "
250212|NCT01125007|"     This study compared the removal of dental biofilm between soft and medium toothbrushes. The     patients refrained from performing mechanical or chemical plaque control for 96 hours to     allow dental biofilm accumulation on the tooth surfaces. After the period of dental biofilm     formation, the quadrants were randomized and the participants brushed different quadrants     with soft and medium toothbrushes, with or without dentifrice. The plaque indices were     analyzed by a blinded examiner before and after toothbrushing. The 2Tone was used for plaque     disclosure and analysis was performed by the Quigley-Hein index modified by Turesky et al.     (1970).   "
250213|NCT01125020|"     The study is designed to investigate the effect of postoperative adjuvant chemotherapy in     prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver     transplantation.   "
250216|NCT01125059|"     What is the influence of methadone on postoperative analgesia after lumbar interbody fusion     in opioid naïve patients or patients who are taking less than equivalent of 15 mg IV morphine     each day? What is the incidence of opioid related postoperative side effects after the     administration of methadone in the operating room?   "
250217|NCT01125072|"     Chest pain is one of the most common complaints that brings a patient to the emergency     department (ED). The differential diagnosis of chest pain is broad and includes cardiac as     well as non-cardiac diseases. One of the initial goals in the ED evaluation of a patient     presenting with chest pain is to rapidly and accurately diagnose the presence or absence of     acute coronary syndrome. The diagnostic accuracy of the initial routine evaluation is often     limited and results in frequent admissions for patients presenting with chest pain for     further diagnostic testing.      Echocardiography has a high sensitivity and specificity for the diagnosis of acute myocardial     infarction. Tissue Doppler imaging with strain and strain rate (SR) measurement is a new     echocardiographic technique, which enables accurate assessment of regional left ventricular     systolic and diastolic function. Prior studies have shown that abnormal strain and SR are     highly sensitive markers of ischemia. Acute ischemia induces early systolic thinning and a     delay in the onset of systolic thickening, a progressive decrease in the rate and degree of     maximal systolic thickening, and an abnormal ischemia-related thickening which occurs after     aortic valve closure. A major obstacle to the routine use of echocardiography in the ED is     the need for portable studies, using heavy, bulky portable echo machines. There are currently     available portable hand-held echo machines (GE-Vivid I) that produce high quality images and     offer an opportunity to incorporate echocardiography into routine practice in the ED.      We propose to study the use of early, portable echocardiography, with detailed assessment of     wall motion and left ventricular function by strain and strain rate measurements, for the     evaluation of chest pain in the ED. We hypothesize that an early with detailed left     ventricular function assessment will be highly sensitive and specific for the diagnosis of     myocardial ischemia, and will enable rapid triage of patients who present to the ED with     chest pain.   "
250218|NCT01125085|"     The aim of this Proof of Concept study is to determine the therapeutic potential of the     L19SIP antibody, labeled with the radionuclide 131I in combination with external beam     radiation, for the treatment of patients with multiple brain metastases following the     promising results with this agent in previous clinical studies.      The L19SIP antibody is a fully human antibody, capable of preferential localization around     tumor blood vessels while sparing normal tissues. The formation of new blood vessels is a     rare event in the adult (exception made for the female reproductive cycle), but is a     pathological feature in most aggressive types of cancer. The presented study follows a Phase     I and a subsequent Phase I/II dose finding and efficacy study with the same agent in patients     with a variety of cancers where 131I-L19SIP had shown an excellent tolerability and     therapeutic benefit for some patients enrolled in the study.   "
250219|NCT01125098|"     Exacerbations of chronic obstructive pulmonary disease (COPD) are the first cause of     admission to Pulmonary Department in Italy and worldwide. Guidelines recommend treating most     patients hospitalized for exacerbations of COPD with antibiotics, even if the role of     bacterial infection is often uncertain and the effect of antibiotics poor. The recommendation     to use antibiotics is guided by clinical signs and symptoms that have an insufficient     diagnostic accuracy, whereas serum biomarkers as procalcitonin (PRO-CT) may guide the     selection of COPD patients who need antibiotic treatment. The main aim of the study is to     investigate whether antibiotics can be safely stopped after 3 days or continued for 10 days     according to a PRO-CT-guided algorithm in patients hospitalized for exacerbations of COPD for     whom guidelines recommend 3-10 days antibiotic treatment based on presence of increased     dyspnoea, sputum and purulence. The study is designed to assess the non inferiority of the     PRO-CT guided plan as compared to the standard guideline recommended plan. The PRO-CT guided     withholding of antibiotics is viewed as an experimental intervention associated with less     antibiotic-associated complications, eg antibiotic resistance and drug-related side-effect     and lower costs. The proposed study is a prospective, randomised controlled, single-blinded     intervention trial comparing the standard with a PRO-CT guided antibiotic treatment plan.     Patients will be recruited from the Pulmonary Department of 18 University or City Hospitals     in Italy, starting October 2006 and continuing until December 2010. Results expected by end     of 2011. The 100 patients randomised to the standard non PRO-CT guided antibiotic treatment     plan will continue antibiotics for 10 days, whereas the 100 patients randomised to the PRO-CT     guided antibiotic treatment plan will continue for 10 days or stop antibiotics on day 3     depending on PRO-CT levels measured at admission, day 1 and day 2. Serum PRO-CT will be     measured in a central laboratory. Patients will be examined at admission, discharge, 10 days,     1, 3 and 6 months. A telephone interview will be obtained at 2, 4 and 5 months. The primary     outcome of the study will be the rate of exacerbations. Secondary outcomes will be hospital     readmission, admission to ICU, change in FEV1, duration of hospitalization, and death. The     sample size was estimated according to the primary outcome of the study.   "
250220|NCT01125111|"     The clinical study of making the evidence with application of Da vinci-Robot assisted low     anterior resection in rectal cancer   "
250221|NCT01125124|"     The primary purpose of this study is to determinate the degree of chest pain on patients with     malignant pleural effusion submitted to pleurodesis with silver nitrate in three different     dosages and concentrations ( 30ml 0.5% ; 30ml 0.3% ; 60ml 0.3%). Our secondary purpose is to     evaluate the efficacy and occurence of adverse effects in the usage of silver nitrate for     pleurodesis in the aforementioned dosages/concentrations.   "
250222|NCT01125137|"     Purpose:      To compare the levels of matrix metalloproteinase-1 (MMP-1), MMP-8, MMP-13 and tissue     inhibitor of metalloproteinases (TIMPs) in keloid skin tissue with normal skin in the same     patient and with normal discarded skin tissue (control). The investigators aim to correlate     between levels of MMPs in patients with keloid scarring in comparison with normal and     discarded tissue.   "
250223|NCT01125150|"     Acanthosis Nigricans is skin disease that associated with hyperinsulinemia. Clinical is     velvety hyperpigmented plaques on neck, axilla, groin. If hyperinsulinemia is improved by     treated with oral metformin and/ or diet control, acanthosis nigricans would be improved as     well. Hyperpigmented plaques will be changed. We assess objective measurement by using     spectroscopic and colorimetric analysis.   "
250224|NCT01125163|"     In preterm infants with birth weights less than 1500 grams, does iron supplementation with     2mg/kg/day in addition to feeding with routine iron-fortified milk (formula or fortified     mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks     adjusted post-menstrual age (or at discharge if sooner)?   "
250225|NCT01125176|"     Our hypothesis is that treatment of CLL with an alternating daily dosing schedule of     thalidomide and lenalidomide may result in better tolerability by decreasing each agent's     individual toxicities, while preserving efficacy, and therefore lead to a longer duration of     therapy and improved responses. Additionally, the combination of the 2 agents may have     additive or synergistic effects therapeutically.      In Cycle -1, odd numbered patients will receive oral thalidomide daily days 1-14 followed by     no treatment on days 15-28. Even numbered patients will receive oral lenalidomide daily on     days 1-14 and then no treatment on days 15-28. Starting with cycle 1, patients will alternate     daily thalidomide (every odd day) with daily lenalidomide (every even day) for days 1-28.     Rituximab will be given on days 1, 8, 15, and 22 starting with Cycle 1, and then again every     6th cycle thereafter (cycles 7, 13, 19, etc.)   "
250226|NCT01125189|"     To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated     interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid     virologic response rates at least 35% greater than those with placebo.   "
251367|NCT01146340|"     The purpose of this study is to determine the safety and efficacy of a short course of     radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk     prostate cancer.   "
250227|NCT01125202|"     The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis     patients, a behavioral intervention to reduce dietary sodium intake. The investigators will     assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and     health-related quality of life. The primary study hypotheses are that participants will gain     less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced     consumption of dietary sodium.   "
250228|NCT01125215|"     The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin     nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.   "
250229|NCT01125228|"     This study will compare the effectiveness of zidovudine (AZT) alone vs. zidovudine plus     interferon (IFN) vs. interferon alone in reducing HIV viral load, lessening immune system     deterioration, and increasing the time to development of the first opportunistic infection in     HIV-infected patients.      HIV-infected persons 18 years of age and older with a T4 lymphocyte count of 500/mm3 or more     and no current opportunistic infections may be eligible for this study. Candidates will be     screened with a medical history, physical examination, blood tests, chest X-ray,     electrocardiogram, urinalysis, and, for patients with Kaposi s sarcoma lesions, measurement,     photographs, and biopsy of lesions.      Patients will be assigned to receive treatment with either zidovudine alone, zidovudine plus     interferon or interferon alone. They will continue treatment until one of the following     occurs:        -  Unacceptable side effects, despite dose modifications        -  Development of an opportunistic infection        -  Decrease in CD4 count by 20 percent or to an absolute count of less than 200/mm3        -  Rapid progression of Kaposi s sarcoma lesions, requiring alternative therapy        -  A decision is made to terminate the study      Patients will be followed long term for viral load, immune function, development of     opportunistic infections, disease progression, and survival.   "
250230|NCT01125241|"     The main purpose of this study is to determine the effects of add-on therapy of wuling     capsule on depressive symptoms in patients with comorbidity of epilepsy and depression, to     evaluate its influences on the frequency and severity of seizures, and to observe its effects     on patients' sleeping condition, quality of life.   "
250231|NCT01125254|"     This study aims to investigate the use of amlodipine, a drug that blocks the uptake of     calcium into cells, in the prevention and treatment of iron overload in patients with     thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and     other organs, blocking these channels might help to prevent the accumulation of iron in these     tissues. The study will follow 10 patients with thalassemia major: 5 will openly receive     amlodipine and 5 will serve as controls, not receiving any additional drugs. Patients will be     monitored through one year with an additional year of follow up after the group using     amlodipine stops its use. Monitoring will occur through the measurement of blood ferritin as     well as live and heart T2* by MRI.   "
250232|NCT01125267|"     The project evaluates a culturally adapted, family-based intervention designed to promote     treatment adherence among Mexican-Americans with schizophrenia using a randomized, controlled     design in a public mental health setting. Mexican-American patients with schizophrenia and     their families were randomly assigned to either: 1) one year of multi- family groups that     emphasize the importance of attitudes towards adherence, subjective norms, and self-perceived     and actual adherence skills in maintaining adherence, added to ongoing customary outpatient     care; 2) standard multi-family groups without an emphasis on medication adherence, added to     customary outpatient care; or 3) customary outpatient care only (monthly pharmacotherapy     sessions and additional services as clinically needed). The study hypotheses are that     subjects assigned to the adapted multi-family group would have better medication adherence,     less psychiatric symptoms and fewer psychiatric hospitalizations throughout the course of the     study (one year of treatment and one year of follow up) compared to the comparison     conditions.   "
250233|NCT01125280|"     The purpose of this study is to apply and validate a clinicoradiological score for the     prediction of severity of strangulated small bowel occlusion (SBO). This score was elaborated     by analyzing clinical, biological and radiological parameters of patients admitted in an     emergency center for acute strangulated SBO. Two clinical, two biological and two     radiological parameters were shown to significantly predict the surgical outcome of SBO     patients.      Since any delay in the management of SBO may result in devastating consequences, a score     predicting the severity of the SBO episode is an essential tool for helping in the management     of SBO patients. A prospective multicenter validation of the score is mandatory for its     extended use.   "
250234|NCT01125293|"     The purpose of this research study is to test the safety of the combination of everolimus,     rituximab and bortezomib. Everolimus is a drug that works by preventing cells in your body     from growing and dividing. Information from basic and other clinical research suggests that     everolimus may also inhibit tumor growth in people with relapsed or refractory lymphoma. The     FDA has approved everolimus for the treatment of multiple myeloma, a cancer that is closely     related to Waldenstrom's Macroglobulinemia. Rituximab is approved by the FDA for the     treatment of non-Hodgkin's lymphoma, which included Waldenstrom's Macroglobulinemia.      Funding Source - FDA OOPD   "
250287|NCT01125982|"     The purpose of this study is to establish validated outcome measures for Postoperative     Fatigue and Postoperative nausea, and to compare clinical impact of postanaesthetic symptoms     during first week after Propofol or Desflurane based anaesthesia.   "
250235|NCT01125306|"     Xal-Ease is a novel Pfizer-Pharmacia device aimed to significantly facilitate the     Xalatan/Xalacom instillation and to avoid loss of Xalatan/Xalacom eye drops due to incorrect     instillation.      Patients on Xalatan/Xalacom who have consumed more than one bottle per month within a year     according to consumption data drawn from the Clalit Health Services database, will use the     Xal-Ease device for a year. The device is expected to reduce consumption of bottles and     result in saving money for both patients and medical care providers.   "
250264|NCT01125683|"     The purpose of this study is to evaluate whether treatment with single and multiple oral     doses of AZD1446 for 1 week will have effect on Quantified Electroencephalography and     Event-Related Potentials in patients with Alzheimers Disease. The total treatment period is 9     weeks, divided into 5 equally long sub-periods of 7 days and 4 wash-out periods of 7 days     each.   "
250236|NCT01125319|"     Hemophagocytic lymphohisticytosis (HLH) is a rare and severe disease of genetic origin in     children (familial-HLH, F-HLH) or affecting adults secondary to infections, hematologic     malignancies or auto-immune diseases (secondary_HLH, S-HLH). F-HLH are due to genetic     mutations affecting the genes of perforin or proteins involved in its secretion, resulting in     the complete loss of lymphocyte cytotoxicity without affecting lymphocyte number. In S-HLH,     the investigators have observed a severe NK cell lymphopenia and a transient loss of     cytotoxicity of unknown mechanism. In this study, the investigators will dissect macrophage     activation mechanisms as well as NK cytotoxicity inability in adults patients suffering of     S-HLH.      Macrophage activation could result from the loss of the retro-control normally exerted by NK     cells, thus the investigators will analyze reciprocal interactions of macrophages and NK     cells during the acute phase and after recovery of S-HLH.   "
250237|NCT01125332|"     The purpose of this work is to estimate the efficiency in terms of pain of the application of     a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in     naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.   "
250238|NCT01125345|"     The purpose of the study was to compare the postoperative PCO results of the single-piece     hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in     patients undergoing bilateral cataract surgery.   "
250239|NCT01125358|"     This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as     assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of     efficacy, safety, and tolerability.   "
250240|NCT01125371|"     African American (AA) women are disproportionately affected by HIV/AIDs. The major risk     factor for HIV acquisition among AA women is high-risk heterosexual sex, including     unprotected vaginal and anal sex, and sex with a high-risk partner. Hazardous alcohol use has     been associated with high risk sexual behaviors and prevalent gonorrhea among women attending     an urban STI clinic, both of which increase a woman's vulnerability to HIV acquisition and     transmission. This application proposes a randomized controlled trial (RCT) of a culturally     tailored computer-directed brief alcohol intervention (CBI) enhanced with cell-phone booster     calls using interactive voice response technology (IVR) and text messages among HIV-infected     and at-risk AA women attending an urban STI Clinic. Hazardous drinking AA women (N=450)     presenting with STI complaints will be randomized to one of three arms: 1) usual clinical     care, 2) clinic-based, CBI, or 3) clinic-based, CBI + 3 booster calls using IVR and text     messages. The CBI, an evidence-based based method for behavior change, will use principles of     motivational interviewing, to counsel on: 1) alcohol use and 2) associated HIV/STI risk     behaviors. Primary outcomes, measured at 3, 6, and 12 month intervals, include     alcohol-related risk behaviors (number of binge drinking episodes, drinking days/week, and     drinks per occasion), sexual risk behaviors (number of partners, episodes of unprotected     vaginal/anal sex, episodes of sex while high), and occurrence of HIV/STI biomarkers. Prior to     implementing the RCT, the CBI and IVR software messages will be revised to: 1) include the     association between hazardous alcohol use and risky sexual behaviors, and 2) ensure their     relevance and acceptability using quantitative/qualitative feedback from a sample of AA women     attending a Baltimore City STI clinic. The proposed research focuses on a particularly     vulnerable population of urban HIV at-risk and HIV-infected AA women seeking treatment in a     public STI clinic and examines two novel BI intervention delivery strategies specifically     tailored to be culturally/socially relevant to this minority population. If the     intervention(s) prove to be effective, study findings will offer real life specialty care     clinics a screening and intervention package that is practical, low cost, and easy to     implement.   "
250241|NCT01125384|"     Throat swabbing is an important instrument in the diagnosis of strep pharyngitis and     sometimes the main argument for antibiotic treatment. There is no firm knowledge about an     appropriate method of the swabbing for receiving maximal sensitivity. We hypothesize that     accurate swabbing from the pus will increase the sensitivity of the swabbing as compared to     free swabbing. In order to check this hypothesis we will compare two swabs from the same     throat. One that will be taken by a physician specifically from the pass and the second will     be taken by a nurse as she used to do it. An increase of 10% of positive results will be     accepted as a significant advantage.   "
250242|NCT01125397|"     Obesity is an ever increasing public health problem in this country. Bariatric surgery is     currently the most effective treatment for morbid obesity and two hundred thousand surgeries     are performed in the United States each year. Unfortunately, despite anatomically successful     surgery, it is estimated that at most surgical centers about 30 percent of patients will not     achieve significant weight loss following surgery. It has been proposed that participation in     preoperative behavior therapy can enhance postoperative outcomes, although empirical evidence     for this premise is lacking. The current study is a pilot project designed to conduct a     prospective randomized trial to examine the impact of participation in a 12-week standardized     preoperative behavioral weight management program on percentage of excess weight loss and     psychosocial and medical outcomes at six months after roux-en-Y gastric bypass surgery. The     cost of bariatric surgery is not covered by this study and only patients local to the     Rochester, Minnesota area are eligible to participate.      It is hypothesized that patients who complete the 12-week behavioral program will experience     greater weight loss and improved psychosocial and medical outcomes compared to controls.   "
250243|NCT01125410|"     The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg     dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to     clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.   "
250244|NCT01125423|"     The purpose of this study is to examine the characteristics of the nerves and the small veins     in the skin of people with fibromyalgia. This information will then be used to identify     possible processes in the skin that may help explain why some people feel pain relief with     the study drug (milnacipran) and others do not. The investigators expect to learn more about     the pathophysiology of fibromyalgia and the way in which milnacipran acts on these patients.     The investigators hypotheses are:        1. The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical          and/or morphological pathology among the sensory innervation.        2. Fibromyalgia patients may have different sites of innervation.        3. Milnacipran may have a therapeutic effect on some fibromyalgia patients.        4. Abnormalities in fibromyalgia patients may predict the likelihood of a good response to          milnacipran.   "
250245|NCT01125436|"     The purpose of this study is to determine if vitamin D will improve physical performance in     older adults with heart failure.   "
250265|NCT01125696|"     The purpose of this study is to compare a regimen of tenofovir/lamivudine/lopinavir-ritonavir     to the WHO-recommended and locally practiced standard of care regimen consisting of     zidovudine/lamivudine/lopinavir-ritonavir during the second and third trimesters of pregnancy     in HIV and HBV co-infected women. This is a phase II study evaluating the safety of the test     regimen in pregnant women and their newborns. While the study is not powered to examine     efficacy, preliminary estimates of transmission of HIV and HBV to the infants and of the rate     of resistance development will be obtained.   "
250247|NCT01125462|"     The development of recombinant DNA technology, culminated in the introduction of the first     recombinant human follicle stimulating hormone (r hFSH), Gonal-f, which further developed to     become Gonal-f Filled-by-Mass (FbM) pen has been used in the fertility treatment since many     years. It has been found that subjects using the pen found it less stressful, easier to use     and more convenient than a conventional syringe and would recommend the prefilled pen to     another woman considering gonadotropin treatment. However, the use of the Gonal-f (FbM) pen     between Serbian subjects is on a very low level though the Gonal f vials with the 75 IU of     follitropin alfa have been present in Serbian market since 2003. On the contrary from the     clinical practice in European countries, Serbian subjects usually receive daily dose of     injectable gonadotropins at the IVF clinics or by partner/family member.      This open-label, multicentric, observational non-interventional study is designed with the     aim to know the reason of Serbian subjects not injecting themselves with Gonal f and the     quality of life (QoL) of Serbian women/couples with the infertility problem.   "
250248|NCT01125475|"     The primary objective is to determine adherence to Rebif® New Formulation administered by     RebiSmart during 12 weeks of therapy in patients with RRMS.   "
250249|NCT01125488|"     The recurrence rates of endometriosis reported in women 5 years after therapy with     gonadotropin releasing hormone (GnRH) agonist were 74% for severe disease . No strategies to     prevent the recurrence of endometriosis have been uniformly successful. Local progesterone     treatment of endometriosis-associated dysmenorrhea with a levonorgestrel-releasing     intrauterine system (LNG-IUS) for 12 months has resulted in a significant reduction in     dysmenorrhea, pelvic pain and dyspareunia; a high degree of patient satisfaction; and a     significant reduction in the volume of rectovaginal endometriotic nodules. LNG-IUS may become     a more important option if a long-term medical suppression of endometriosis.      Based on literature review, I hypothesized that maintenance therapy of LNG-IUS in conjunction     with the GnRH agonist could lower the recurrence rates endometriosis after conservative     surgery. We try to answer the question whether maintenance therapy of LNG-IUS in conjunction     with the GnRH agonist could lower the recurrence rates and thus extend the symptom-free     interval (menorrhagia and dysmenorrhea) as compared to GnRH agonist alone after conservative     surgery in severe endometriosis cases.   "
250250|NCT01125501|"     Protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic     syndrome and proteomics will identify protein profiles that correlate with markers or/changes     in oxidative stress.   "
250251|NCT01125514|"     This study assessed the interaction between single and multiple doses of aliskiren (150 mg     and 300 mg) and furosemide (60 mg) in patients with heart failure.   "
250252|NCT01125527|"     This study will evaluate the safety and immunogenicity of single dose of two commercially     available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59     months of age.   "
250253|NCT01125540|"     Patients with seasonal allergic conjunctivitis are normally advised to avoid contact lens     wear when they are having symptoms. However, modern soft contact lenses which are disposed of     daily offer the potential to protect and lubricate the ocular surface. This study examines     this possible effect.   "
250254|NCT01125553|"     This trial is conducted in the United States of America (USA). The aim of the trial is to     compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in     healthy subjects.   "
250255|NCT01125566|"     To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v.     chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who     failed one prior trastuzumab (Herceptin®) treatment   "
250256|NCT01125579|"     Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of     nervous restlessness in children aged 6 to 12.      Each patient is treated with NPB. No placebo group is established. Course and severity of     symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a     Visual Analogue Scale (VAS). A standardized questionnaire (Parent Child Behaviour Checklist     (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's     discretion. The planned treatment and observation period is 2 - 4 weeks.   "
250257|NCT01125592|"     Makers of ionic foot baths claim that their machines can eliminate heavy metals from the     body. Researchers at the Canadian College of Naturopathic Medicine are evaluating the ability     of an ionic foot bath to help eliminate heavy metals from the body by rigorously testing the     machine under controlled conditions. The machine will first be tested without feet under     normal operating conditions and again after operation under normal conditions with foot     immersion.   "
250258|NCT01125605|"     The purpose of this observational study is to give an overview of the use of PASCONAL     NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to     nervousness.   "
250259|NCT01125618|"     The Millennium Villages Project involves the coordinated and simultaneous delivery of a     package of proven interventions in health, agriculture, infrastructure and education. The     project works in partnership with governments in 10 African countries in areas where progress     towards achieving the Millennium Development Goals has been insufficient.      The Project evaluation will test the following hypotheses:        1. That after 5 years of operation, villages exposed to the MVP intervention will have a          lower rate of under-5 mortality and parallel gains in MDG-related secondary outcomes          when compared to similar villages not receiving the intervention.        2. That the coordinated delivery a multi-sector package of health and development          interventions implemented through a broad-based local partnership is feasible in a          diversity of sub-Saharan African contexts, and;        3. The intervention package can be delivered at a scalable cost of $40 per person per year          in the health sector and $110 per person per year in total   "
250260|NCT01125631|"     The purpose of the study is to examine the safety and tolerability of a multiple dose of     PF-04360365 administered over approximately 10 minutes in Japanese patients with     mild-to-moderate Alzheimer's disease and to characterize the pharmacokinetics of PF-04360365     following administration of multiple doses in Japanese patients with mild-to-moderate     Alzheimer's disease.   "
250288|NCT01125995|"     The purpose of the study is to evaluate the efficacy and toxicity of different timing of     concurrent chemoradiation in the treatment of limited disease status Small-cell lung cancer.   "
250266|NCT01125709|"     The aim of the proposed research is to compare two commonly used pediatric strength testing     measures: handheld myometry (HHM) and CINRG Quantitative Measurement System (CQMS), with the     goal of identifying a sensitive and valid tool for measuring muscle strength in children with     DMD. The data obtained from this study will be used to make recommendations for strength     measurement endpoints in prospective muscular dystrophy trials and provide more reliable and     accurate recommendations in the clinic for strength assessment. This study will be performed     at six participating sites in the Cooperative International Neuromuscular Research Group     (CINRG).   "
250267|NCT01125722|"     The purpose of this study is to determine whether the non-invasive neurostimulation patch is     effective in the treatment of urgency, frequency and urge (urinary) incontinence.   "
250268|NCT01125735|"     The purpose of this study is to evaluate the effectiveness of MIST Therapy in combination     with standard of care (SOC) compared to SOC alone on reducing the bacteria in your wound and     preparing the wound bed for surgical closure in patients that have chronic, non-healing     wounds.      The MIST Therapy System delivers therapeutic ultrasound to the wound bed without direct     contact. Saline solution is converted into fine particles and released towards the wound by     sound pressure waves to remove dead or damaged tissue. The MIST Therapy System is currently     the only FDA cleared non-contact ultrasound device to promote wound healing.      Standard of care procedures include surgical debridement of the wound in the operating room     to remove all infected, dead tissue and bone.      This research is being done because the investigators do not know which of these     commonly-used treatments is better, and because the investigators would like to evaluate the     bacteria that is present in the wound.   "
250269|NCT01125748|"     This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants     who completed the EXCELS study (NCT00252135) and had received long-term treatment with     Xolair. In addition, participants who did not participate in the EXCELS study but received     long-term (~5 years) treatment with Xolair were allowed to enter the study.   "
250270|NCT01125761|"     Considering the pathogenesis of several allergic skin diseases to be investigated in this     study as well as the pharmacodynamic mechanisms of the association of dexamethasone and     clemastine fumarate, it is believed that the components of topical medication may act     synergistically in the reduction of signs and symptoms of the diseases in question. Therefore     it is expected that the association promotes results significantly superior to dexamethasone     alone.   "
250271|NCT01125774|"     This is a multicenter study to test the hypothesis that telcagepant is superior to placebo in     preventing perimenstrual migraines as measured by mean monthly headaches during the entire     treatment period. This study will also evaluate the safety and tolerability of telcagepant     for female migraine participants.   "
250272|NCT01125787|"     Investigational Drug:      Ofatumumab (Azerra)      Route of Administration:      Intravenous (IV)      Hypothesis:      This study is designed to assess the toxicity and overall response rate. Ofatumumab is a     fully human monoclonal antibody (A type of protein made in the laboratory that can bind to     substances in the body, including tumor cells) that shows promising activity in the treatment     of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA     approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given     alone.      Participation:      Approximately 38 previously untreated CLL subjects will participate in this study over two     years.      Treatment Plan:      A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV     300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by     bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be     administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only     patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will     be given on day 1 only.      Follow-up:      Patients will be followed monthly for six months, then every three months for five years then     annually thereafter.   "
250273|NCT01125800|"     Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics and     pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent     or refractory medulloblastoma, or other tumors potentially dependent on Hedgehog signaling     pathway.      Phase II study is to assess preliminary efficacy in both adult and pediatric patients with     recurrent or refractory MB.   "
250274|NCT01125813|"     This study will determine the efficacy of human-cl rhFVIII in previously treated patients     with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in     surgical prophylaxis.   "
250275|NCT01125826|"     The purpose of this study is to culture primary human brain tumor cells with the specific     aims of:        1. Develop primary cultures from human brain tumor surgical specimens        2. Determine the genetic and molecular fingerprints of brain tumors that may have          prognostic significance        3. Delineate the mechanisms underlying oncogenesis of brain tumors.        4. Perform in vitro assays with brain tumor derived primary cultures to assess the efficacy          of novel therapeutic agents.   "
250276|NCT01125839|"     Vertebral osteomyelitis is a uncommon disease that can lead to neurologic deficits if not     diagnosed in time. The etiologies of vertebral osteomyelitis include pyogenic bacteria, M.     tuberculosis, Brucella species, and fungus. The aim of this study is to describe the clinical     features and microbiological/radiological characteristics of patients with vertebral     osteomyelitis, and investigate the useful tips for the differential diagnosis of vertebral     osteomyelitis.   "
250277|NCT01125852|"     Peptic ulcer bleeding is a common disorder. Despite optimal endoscopic and medical treatment,     there is a high risk of rebleeding and high mortality. In this study the investigators     examine whether combined endoscopic haemostasis and angiographic embolization resolves in a     better outcome than the traditional use of endoscopic haemostasis alone. The study is a     randomised controlled trail.   "
250291|NCT01126034|"     The investigators hypothesized that:      1) an intervention targeted at the prescribing physician would increase the rate of a     metoclopramide discontinuation among patients prescribed the medication for questionable or     unclear indications; and 2) the discontinuation would be durable.   "
250722|NCT01137916|"     The objective of the present study is to evaluate the activity and safety of imatinib in     patients with aggressive fibromatosis who, after receiving the standard therapy, show an     inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.   "
250278|NCT01125865|"     The overall median survival of nonresectable malignant hilar obstruction in most series has     been less than 6 months. Most patients with malignant hilar obstruction present with advanced     disease, making palliative endoscopic drainage the principal therapeutic option. However, the     optimal endoscopic management strategy is contentious. Almost all of the published data     comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common     bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have     favored metallic stents when compared with plastic stents in patients with distal malignant     obstruction expected to live at least 3 to 6 months.      There are few comparative study as to whether self-expanding metallic or plastic stent,     especially DLS (double layer plastic stent) are preferable in the technical success, stent     patency, and cost-effectiveness for palliating malignant hilar obstruction.      The study was designed to compare the the technical success, stent patency, and     cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar     obstruction.   "
250279|NCT01125878|"     Investigators are interested in learning how appetite responds to certain types of starch and     fiber mixtures. In this research study, subjects will be asked to consume cookie bars     containing different types of starch and fiber mixtures, then describe their feelings of     hunger, fullness and desire to eat for the 3 hour study period. Subjects will be asked to do     this on four separate occasions. Following the 3 hour study period, a deli-style lunch will     be served. Investigators want to see how appetite responds to these four different starch and     fiber mixtures.   "
250280|NCT01125891|"     Treatment of cancer is often more effective when two or more drugs are used together. For     example, when gemcitabine, an approved drug, and ON 01910.Na, a new investigational     anti-cancer drug, are used together to treat cancer cells in laboratory animals, there is     more inhibition of the growth of the cancer cells compared to either drug used by itself.     These results offer promise that gemcitabine and ON 01910.Na could be used to treat cancer in     patients. However, before studies that seek to find out if gemcitabine and ON 01910.Na is an     effective combination in patients can be done, doctors must first know what is largest, safe     dose of ON 01910.Na that can be used in combination with gemcitabine. This study is designed     to answer that question.   "
250281|NCT01125904|"     An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being     tested for its' palatability in adults.   "
250282|NCT01125917|"     The purpose of the extension phase is to evaluate the long-term safety and tolerability of     buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h     and may up- or down-titrate the dose [up to BTDS 20 micrograms (mcg) / hour (h)] depending on     adequate pain relief and tolerability.   "
250283|NCT01125930|"     Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with     frequent flushing, topical sensitivity and prominent blood vessels. We think that long term     damage to skin from the sun (photodamage) may play a role in causing this type of rosacea.     Tretinoin is a topical medication that is known to improve photodamage. We want to find out     if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve     erythematotelangiectatic rosacea (ETR).   "
250284|NCT01125943|"     The introduction of angiogenesis inhibitors has remarkably improved treatment of patients     with several types of cancer. One of the most reported side effects of angiogenesis     inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody     against vascular endothelial growth factor, hypertension had an overall incidence up to 32%.     The increase in blood pressure occurs early in treatment. The etiology of hypertension caused     by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this     side effect is essential for optimal treatment with this class of drugs.      The primary objective is to explore the effect of bevacizumab infusion on     endothelium-dependent vasodilation of forearm resistance arteries.   "
250285|NCT01125956|"     The specific aims of this study are to test whether in a cohort of low-income minority     veterans with poor diabetes mellitus (DM) control:        1. Peer counseling is an effective means of reducing HbA1c (a measure of glucose control).        2. Financial incentives are an effective means of reducing HbA1c. This is a randomized          controlled pilot study. There will be 3 arms: 1) a control group of poorly controlled          diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial          incentives without peers. Ultimately, contingent on the success of this intervention,          the researchers plan to apply for funding for a large scale intervention employing both          peer counseling and incentives to improve DM control in low income and minority patients          who are at high risk for premature morbidity and mortality.   "
250286|NCT01125969|"     In recent years, social networks have garnered attention in both academic journals and the     lay press because of strong associations demonstrated in retrospective studies between social     networks and incidence of major health problems such as obesity and smoking. Financial     incentives have also been demonstrated to improve health behaviors in obesity, smoking, and     medication adherence. We propose to conduct a randomized controlled trial among a     predominantly African American population with persistently poor diabetes mellitus (DM)     control to examine whether two novel interventions, lottery based financial incentives and     telephone based one-on-one peer mentoring (the 'buddy system'), can significantly ameliorate     disparities in poor DM control.      The intervention is based on epidemiologic evidence, randomized controlled trials, and pilot     studies demonstrating: 1) Lottery based financial incentives are a powerful motivator of     behavior change; 2) One-on-one peer mentoring is a flexible, cost-efficient means of     increasing DM specific social support and may be particularly salient in minority     communities; and 3) Matching patients with poorly controlled DM with a similar individual     from their community who has gained control of their DM draws on existing community assets in     creating an inherently culturally competent intervention. DM patients with poor DM control     will be randomized to 1 of 4 arms: usual care; telephone based one-on-one peer mentoring;     lottery based financial incentives; and peer mentoring plus financial incentives.      The Specific Aims are to test: 1) The effectiveness of telephone based one-on-one peer     mentoring in improving glycemic control relative to usual care; 2) The effectiveness of     lottery based financial incentives in improving glycemic control relative to usual care; 3)     The effectiveness of combining peer mentoring and financial incentives relative to control;     and 4) The relative cost effectiveness of all four approaches. In exploratory analyses, we     will examine whether African American patients enrolled in intervention arms have greater     improvement in glycemic control than white patients, whether intervention group patients     experience greater improvements in blood pressure (BP) and lipid control, and whether peer     mentors experience improvements in their own health. We will pair mentors with mentees based     on race, gender, age, and disease severity. The active intervention will be run for a 6-month     time period, with participants followed for an additional 6 months to determine if effects     persist post intervention.      The proposed interventions address multiple barriers to effective disease management common     among patients with DM. If effective, these interventions could provide important models for     improving glycemic control in general and, in particular, for addressing racial disparities     in DM outcomes.   "
250290|NCT01126021|"     The study plans to test the effectiveness of behavioral economics based incentives to promote     the daily use of computer programs designed to improve memory and mental acuity. Subjects     will be recruited from the Pittsburgh metropolitan area. The primary objective is to     determine the impact of structured financial incentives on the number of computer-based     cognitive exercises completed during a 3 month intervention period.   "
250292|NCT01126047|"     The purpose of this study is to check the accuracy of a procedure called exhaled carbon     monoxide (eCO) testing. Exhaled carbon monoxide is used by physicians to help assess     breathing in people with conditions like asthma and emphysema. eCO may be used to correct     another breathing test (called diffusing capacity, or DLCO). Blood collection is usually     required to correct the DLCO, so validation of the eCO test may help avoid that blood     collection.   "
250293|NCT01126060|"     Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well.     However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel     is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus     reducing op time and postoperative drain, which is important to minimize hospital stay. The     investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted     procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior     compartment neck dissection.   "
250294|NCT01126073|"     Primary objective:      To evaluate the impact of 12 weeks' administration of extended release niacin/laropiprant     (ERN/LRPT) compared to placebo added to statin therapy on endothelial dependant dilatation of     the arterial wall assessed by brachial vasoreactivity in stable coronary heart disease (CHD)     patients.      Secondary objective:      To evaluate the impact of 12 weeks' administration of extended release niacin/laropiprant     (ERN/LRPT) compared to placebo added to statin therapy on serum lipids and the parameters of     inflammation in stable coronary heart disease (CHD) patients.      CHD-coronary heart disease ER-extended release   "
250295|NCT01126086|"     Primary Objective:      - To study effect of mild and moderate hepatic impairment on the pharmacokinetics of     otamixaban.      Secondary Objective:      - To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate     hepatic impairment and in matched subjects with normal hepatic function.   "
250296|NCT01126099|"     A study of outpatient participants with Alzheimer's disease or a related dementia who have     difficult behaviors that are upsetting for them or their caregivers. Prazosin is a medication     that is commonly used to treat people with high blood pressure. Research with prazosin has     shown that it may be effective in treating behavioral problems by reducing excess adrenalin     effects in the brain.   "
250297|NCT01126112|"     The purpose of the study is to evaluate the efficacy and safety of first-line single-agent     panitumumab in frail elderly patients with advanced Wild Type K-RAS colorectal cancer   "
250298|NCT01126125|"     In iodine-deficient countries or regions that have inadequate iodized salt distribution, the     World Health Organization (WHO) recommends choosing one of two methods to improve iodine     intakes in breastfeeding infants: 1) iodine supplement (400 mg as iodized oil; 1/year) to the     breastfeeding mother, or 2) iodine supplement (100 mg as iodized oil; 1/year) directly to the     infant. However, the relative efficacy of these two methods of providing iodine to the     newborn has never been directly compared. Whether the first method of iodine supplementation     to the breast feeding mother can significantly improve iodine supply and maintain normal     thyroid function in her infant remains unclear. This study will directly compare these two     strategies. The hypothesis is that the two strategies will be equally effective in providing     iodine to the newborn.   "
250299|NCT01126138|"     It is a phase III trial to explore the efficacy and safety of vinorelbine plus capecitabine     (NX) and docetaxel plus capecitabine (TX) as first line treatment followed by capecitabine     alone till Progressive Disease(PD). We plan to enroll 200 pts for limited budget and the     non-inferior trend of the two curves is anticipated.   "
250300|NCT01126151|"     Examine the efficacy of parent interventions to prevent college student drinking in first     year students.   "
250301|NCT01126164|"     Parent and peer interventions to reduce student drinking   "
250302|NCT01126177|"     When people with asthma get respiratory virus such as a cold or flu it often increases asthma     symptoms. The investigators will test the study medication to find out if it can prevent the     virus spreading from the nose to the lungs.      SNG001 contains Interferon-beta that occurs naturally in the body. In this study, SNG001 will     be given by a nebuliser.   "
250303|NCT01126190|"     Determination of the effect of Neugranin on the duration and severity of severe neutropenia     in subjects receiving doxorubicin in combination with docetaxel.   "
250304|NCT01126203|"     Multi-center, prospective, randomized, controlled clinical trial to compare selective laser     trabeculoplasty (SLT) and Argon laser trabeculoplasty (ALT) in pseudoexfoliation glaucoma and     ocular hypertension patients. IOP will be recorded, at baseline, 6 weeks, 6 months and 1 year     after the laser procedure.   "
250305|NCT01126216|"     Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis   "
250306|NCT01126229|"     The investigators aim to conduct a randomized placebo controlled pilot study to determine     whether resveratrol, a dietary ingredient, supplementation is safe and improves memory and     physical performance in older adults. Loss in memory and physical performance is a frequent     complaint in older adults and a growing public health issue. Additionally, later adulthood is     associated with a normative decline in both working and primary memory as well as domains     including attention, speed of processing and executive function. Resveratrol is safely     tolerated in pre-clinical models and in dose-escalation human studies. It also has     demonstrated beneficial effects on memory and performance in pre-clinical models. Therefore,     this study will take the next step in understanding the longer-term safety (3 months) and     efficacy of resveratrol supplementation on age-related health conditions.   "
250381|NCT01133470|"     The purpose of this study is to        1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine          HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets.        2. Monitor the adverse events and ensure the safety of subjects.   "
250307|NCT01126242|"     The objective of this study is to compare tape versus semi rigid support versus lace up brace     treatment for acute lateral ankle ligament injuries with regard to clinical outcome and cost     effectiveness.      There is a difference of 10 in functional outcome (Karlsson Score) between non-elastic     adhesive taping and semi-rigid and lace-up ankle support, in favour of the last, for the     treatment of acute lateral ankle ligament injury at 6 months follow-up.   "
250308|NCT01126255|"     This is a randomized trial comparing progesterone with conventional clobetasol propionate in     patients with vulvar lichen sclerosus.   "
250309|NCT01126268|"     The purpose of this study is to document the clinical and bacteriological efficacy of     retapamulin in the treatment of subjects with bacterial infections, including impetigo,     folliculitis, and minor soft tissue infections including secondarily infected eczema presumed     to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to     98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound     cultures will be collected, and then subjects will apply topical retapamulin twice daily for     five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus     aureus (MRSA) infection based on clinical presentation and physical exam, as well as     bacteriological efficacy based on culture results. It is anticipated that approximately 75     patients will be enrolled, with expectation that approximately 50 of these patients will have     MRSA infections.   "
250310|NCT01126281|"     The aim of this study is to evaluate the effect and safety of Floseal in this preliminary     prospective trial with patients undergoing acute laparoscopic cholecystectomy for acute     cholecystitis   "
250311|NCT01126294|"     Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or     placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety     will be assessed over the 24 hour period following surgery.   "
250312|NCT01126307|"     Epilepsy is one of the most common chronic neurological diseases, affecting 300,000     Canadians. One in 3 epilepsy patients have refractory seizures meaning that all antiseizure     drugs fail to control their seizures. This drug resistance in epilepsy may be related to the     over expression of multidrug resistance proteins (MDR). Varapamil inhibits MDR. We propose to     add verapamil/placebo to patients' anti epilepsy medication for 3 months. Patients who     receive placebo will have verapamil added for 3 months after the completion of the     double-blind treatment period. Seizure frequency/severity will be tracked. Blood samples for     DNA will be collected. There will be 9 clinic visits over 32 weeks. ECG and echocardiogram     will be done at baseline and repeated if necessary   "
250313|NCT01126320|"     Ventilator Associated Pneumonia (VAP) is a common complication experienced by mechanically     ventilated patients and within the framework of Respiratory Intensive Care Units. The     AnapnoGuard system, developed by Hospitech Respiration Ltd. is a ventilation guard system     that includes a number of unique characteristics. This study was designed to test the     frequency VAP in mechanically ventilated ICU patients using the AnapnoGuard System.   "
250314|NCT01126333|"     Allograft nephropathy is the most common cause of allograft failure following kidney     transplantation. Among putative etiologies, cumulative exposure to calcineurin inhibitors may     be one of the important progression factors.      Spare the Nephron(STN) is a unique study. Patients were randomized to either continue     center-specific Calcinerium Inhibitor (CNI) therapy or have CNI replaced with sirolimus     within the first six months after transplantation. Approximately 305 patients were enrolled     in the study. More than 230 patients finished 2 years of follow-up. There was better patient     and graft survival in those converted to sirolimus. There was also a 10% improvement in the     kidney function of those who were converted. In this cohort, we wish to explore the     durability of this improvement.   "
250315|NCT01126346|"     RATIONALE: An orientation and patient education program and telephone counseling may help     improve the quality of life in patients with peritoneal surface malignancies.      PURPOSE: This clinical trial studies quality of life and survivorship care in patients     undergoing surgery and chemotherapy for peritoneal surface malignancies.   "
250316|NCT01126359|"     The purpose of this prospective study is to compare pain levels and pain medication dose     requirements in patients with topical negative pressure (TNP) dressings removed in a standard     manner (i.v. or p.o. pain meds) compared to dressings removed with lidocaine analgesia, via     injection retrograde up the suction tube into the foam prior to removal. Our null hypothesis     is that there will be no difference in overall pain scores or medication requirements when     patients receive a saline, control injection and pain medications, compared to when their     dressings are changed with a lidocaine injection into the sponge, with pain medications. Our     objective is to disprove this null hypothesis with statistical significance.   "
250317|NCT01126372|"     Prematurely born infants with ductal-dependent congenital heart disease (CHD) are at     increased risk to develop necrotizing enterocolitis (NEC). Abnormal left to right blood flow     through a patent ductus arteriosus can cause intestinal ischemia and compromise the     gastrointestinal tract as a barrier to infection. In some infants, bacterial translocation     leads to NEC which may result in death, intestinal perforation, cholestasis and, at the very     least, feeding problems. Predicting which infants with CHD will develop NEC will potentially     decrease the severity of disease if interventions were started earlier.      Near-infrared spectroscopy (NIRS) allows determination of regional oxygen saturation levels     in tissues such as brain, kidney, and as recently reported, intestine. This study will test     whether or not decreasing intestinal oxygen saturations can predict the development of NEC in     this at risk population before the symptoms become severe. NIRS probes will be placed on the     forehead, flank and abdomen of eligible infants and regional oxygen saturations will be     recorded prospectively and continuously with the clinical care team blinded to the data. The     development of NEC and significant feeding problems will then be correlated with the regional     oxygen saturations to determine whether decreased intestinal oxygen saturations predicted     early signs and symptoms of NEC.      We anticipate generating pilot data in 30 infants who meet inclusion criteria. Support of     this research will be provided partially by Somanetics, the manufacturer of the INVOS     regional oxygen saturation monitors. They will, however, have no control over the data     generated by this study.   "
250382|NCT01133483|"     The purpose of this study is to        1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine          HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets.        2. Monitor the adverse events and ensure the safety of subjects.   "
250318|NCT01126385|"     A new mechanical device was developed in order to provide the surgeon with intraoperative     information about the mechanical strength of the cancellous bone within the vertebral body.     DensiProbe Spine is intended to be used in patients undergoing transpedicular stabilization     of the thoracolumbar spine. The objective of the DensiProbe Spine pilot study is to     investigate the handling and feasibility of the DensiProbe Spine measurement device.   "
250319|NCT01126398|"     This study is designed as a prediction trial. That is, our primary purpose is to develop a     model that can be applied clinically as a user-friendly baseline questionnaire that is     capable of predicting success or failure based on a patient's pre-surgical expectations     of their final outcome. In the process, a secondary goal is to develop an outcomes measure.   "
250320|NCT01126411|"     The purpose of this study is to investigate, if Immunoadsorption of autoantibodies with     subsequent substitution of immunoglobulins is able to improve haemodynamics in patients with     pulmonary hypertension.   "
250321|NCT01126424|"     The purpose is to compare solifenacin and oxybutynin with an inactive tablet and assess any     potential effects on mental ability.   "
250322|NCT01126437|"     Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations     have been limited to 4-week crossover studies. Therefore, prospective data from a trial of     adequate size and duration is required to establish that compared to tiotropium HandiHaler®,     tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior     effects on exacerbations.   "
250323|NCT01126450|"     RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the     tumor. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them. Giving lenalidomide together with     cetuximab may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when     given together with cetuximab in treating patients with metastatic colorectal cancer.   "
250324|NCT01126463|"     This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol     activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The     new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the     radioprotection constraints and hence the duration of the hospitalisation in a protected room     from 8 to 1 day.   "
250325|NCT01126476|"     The purpose of this study is to determine the feasibility of using proton radiotherapy for     reirradiation of recurrent malignancies.   "
250326|NCT01126502|"     This phase I trial is studying the side effects and the best dose of alvespimycin     hydrochloride in treating patients with relapsed chronic lymphocytic leukemia (CLL), small     lymphocytic lymphoma (SLL), or B-cell prolymphocytic leukemia (B-PLL). Drugs used in     chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop the growth     of cancer cells, either by killing the cells or by stopping them from dividing.   "
250327|NCT01126515|"     The purpose of this study is to evaluate Brain MRI (Magnetic Resonance Imaging), and Brain CT     (Computed Tomography) Angiogram data in subjects who participate in the Hyperbaric Oxygen     for Chronic Stable Brain Injury (HYBOBI) study. Including information from MRI and CT     studies provide information about whether hyperbaric oxygen improves brain function in     subjects who have had a brain injury. Subjects will complete MR and CT scans twice during the     study. The first MR and CT will be performed prior to the first hyperbaric session of the     HYBOBI study, and the second will be performed within two weeks following the last hyperbaric     session.   "
250328|NCT01126528|"     This study is a randomized placebo-controlled trial of oral weekly vitamin D3     (cholecalciferol) supplementation during the third trimester of pregnancy among women in     Dhaka, Bangladesh. The overall goal of the study is to establish whether there is evidence     that improving vitamin D status among pregnant women in Bangladesh will enhance the     resistance of the infant offspring to infection.      The aims of the study are to assess the effect of supplementation on 1) maternal and infant     vitamin D status (based on blood concentrations of a vitamin D metabolite) and, 2) markers of     neonatal immune function.   "
250329|NCT01126541|"     This study will compare the efficacy and safety of re-treatment with 2 doses of MabThera     (rituximab) in patients with active rheumatoid arthritis (RA) who have previously experienced     an inadequate response or intolerance to anti-tumor necrosis factor (anti-TNF) therapies     etanercept, infliximab or adalimumab therapy. All patients will receive infusions of 1000 mg     intravenous (IV) MabThera on Days 1 and 15; at Week 24 patients who have demonstrated a     moderate or good response will be randomized to receive re-treatment with either 1 or 2     additional infusions of 1000 mg IV MabThera. The anticipated time on study treatment is 2+     years, and the target sample size is 100-500 individuals.   "
250330|NCT01126554|"     Comparison of ICG liver testing with copeptin and SAPS II score as prognostic markers in     critically ill patients.   "
250331|NCT01126567|"     The objective of this study is to determine the effects of cerebrospinal fluid sampling rate     on biomarker levels of young, healthy volunteers.   "
250332|NCT01126580|"     The purpose of this study is to determine if LY2189265 is safe and effective in reducing     glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2     Diabetes.   "
250333|NCT01126593|"     Subacromial pain catheters have been used with uncertain efficacy for many years after     rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that     postoperative subacromial continuous infusion bupivacaine catheters will provide no pain     control benefits over placebo infusions or no catheter use.   "
250334|NCT01126606|"     Primary Objective:      To evaluate the potential of hydratation and renewal of the mucosa, through corneometry     measurement and individual questionnaire perception.      Secondary Objective:      To evaluate the safety in normal condition of use.   "
250335|NCT01126619|"     In recent years, biologics have changed the treatment of psoriasis, giving us additional     therapeutic options that are potentially less toxic to the liver, kidneys, and bone marrow     and are not teratogenic. Nevertheless, traditional systemic therapies continue to play an     important role in the treatment of psoriasis in Turkey, even in patients who are requiring     biologic treatments according to national recommendations. This study is designated to     observe the effectiveness and safety of tumor necrosis factor inhibitors in patients with     moderate to severe psoriasis.   "
250358|NCT01126918|"     This three-site effectiveness trial will test whether a brief dissonance-based eating     disorder prevention program produces intervention effects when college counselors,     psychologists, and nurses are responsible for participant recruitment, screening, and     intervention delivery under ecologically valid conditions.   "
250337|NCT01126645|"     The purpose of this study is to evaluate Sorafenib and local microtherapy guided by Primovist     enhanced MRI in patients with inoperable liver cancer (HCC).      Methodology:      Patients with a diagnosis of hepatocellular carcinoma will receive either:        -  local ablation therapy of liver lesions by radiofrequency ablation followed by sorafenib          or placebo (local ablation group), or        -  radioembolization (SIRT) + sorafenib or sorafenib alone (palliative treatment group).      In each study group, patients will be randomized to one of the two treatment arms following a     pre-defined randomization plan. Randomization will be on a 1:1 basis in the local ablation     group and on the basis of 10 (sorafenib only) : 11 (SIRT + sorafenib) in the palliative     treatment group.      Patients in the local ablation group will be followed at 2 months intervals for recurrence     and overall survival, patients in the palliative treatment group will be followed for overall     survival. Follow-up in each study group will end 24 months after inclusion of the last     patient into the respective study group.      The assignment of patients to the local ablation or palliative study group will be based on     the ablative potential of RFA (local ablation if ≤4 tumors, each ≤5 cm in size). Diagnostic     imaging will be used to guide this decision. The assignment to the local ablation or the     palliative treatment group will be made by the local investigator.      As a sub-study, all patients will undergo Primovist®-enhanced MRI in addition to     contrast-enhanced CT before assignment to one treatment group. The goal of the sub-study is     to assess the value of Primovist®-enhanced MRI to correctly stratify patients for a local     ablation or palliative treatment strategy. Primovist®-enhanced MRI will be compared with     contrast-enhanced multislice CT using a truth panel assessment as the standard of reference.     In addition, Primovist-enhanced MRI and contrast-enhanced CT will be obtained during     follow-up of patients in the local ablation group to assess its potential for detection of     recurrence.   "
250338|NCT01126658|"     The purpose of this study is to discover a mathematic equation to express the intracranial     pressure-volume (P-V) curve and a single indicator to reflect the status of the curve.   "
250339|NCT01126671|"     This double blind, randomized controlled trial compares two supplemental doses of vitamin D     in health adolescents.   "
250340|NCT01126684|"     To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary     albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond     those on lipid profile. Glycemic parameters, novel cardiovascular risk factors and safety     parameters will be also evaluated.   "
250341|NCT01126697|"     The study will include 120 participants aged 8 and up with Duchenne, Becker, or autosomal     recessive limb-girdle (specifically: LGMD 2C-2F and 2I) muscular dystrophies that have no     clinical cardiac symptoms. Participants will be randomized to one of four arms: Arm 1 CoQ10     alone, Arm 2 Lisinopril alone, Arm 3 CoQ10 and Lisinopril or Arm 4 No study medication.     Randomization will be stratified by ambulatory status and corticosteroid use. The primary     outcome for the study is the myocardial performance index (MPI), measured by standard Doppler     echocardiography. The study will last 24 months with visits at Months 0.5,1.5, 6, 12, 18 and     24.      Following completion of the Clinical Trial of Coenzyme Q10 and Lisinopril, participants will     be offered participation in a companion protocol: PITT1215 A Natural History Companion Study     to PITT0908: Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies. The     objective of this study is to evaluate the longitudinal natural history of DMD, BMD, and     LGMD2I and to evaluate the effects of Coenzyme Q10 and/or Lisinopril on prevention of cardiac     dysfunction in these disorders.This will be an 18-month longitudinal natural history study     designed to accompany the Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular     Dystrophies.   "
250342|NCT01126710|"     The purpose of this study is to investigate the safety and efficacy of an optical device     designed and developed for monitoring the intravenous infusion site for infiltration. The     hypothesis is that the changes in optical signals measured near the infusion site using the     optical device can be used to monitor intravenous infusion for infiltration.   "
250343|NCT01126723|"     The aim of this study is determine the effects of Tai Chi exercise, as compared to an     education-based control intervention, on cardiovascular and balance system function in older     people at risk of developing frailty. We hypothesize that long-term Tai Chi training will     improve specific nonlinear properties associated of cardiovascular and balance dynamics in     this population.   "
250344|NCT01126736|"     The purpose of this study is to determine whether Eribulin Mesylate Administered in     Combination with Pemetrexed is safe and tolerable and to gain a preliminary indication of     clinical benefit when administered to Patients with Stage IIIB or IV Nonsquamous Non Small     Cell Lung Cancer.   "
250345|NCT01126749|"     The purpose of this study is to determine whether Patients with Locally Advanced or     Metastatic Bladder Cancer who receive Eribulin Mesylate Administered in Combination with     Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy is     safety and tolerable when administered to patients with locally advanced or metastatic     bladder cancer and to gain preliminary data on whether patients may benefit from this     combination.   "
250346|NCT01126762|"     The overall goal of this project is to establish a pilot study to develop and refine an     intervention to promote consumption of fish low in mercury and high in n-3 PUFA among     pregnant women. The investigators will demonstrate our ability to recruit pregnant women,     influence their fish consumption, and measure changes in nutrient and toxicant biomarkers.   "
250347|NCT01126775|"     Silent strokes are more frequent than clinical apparent strokes and can be detected     noninvasively by MRI-investigations of the brain. Persons with silent strokes have a     considerably increased risk for clinical apparent strokes as well as for the development of     dementia. Intention of the study is the detection of silent strokes and microbleedings by     standardized cranial MRI in 1000 participants (500 high-risk and 500 low-risk persons for     cerebrovascular accidents) after a standardized neurological and neuropsychological     examination. Results will be the base of early detection and early preventive strategies of     cerebrovascular accidents in high-risk persons.      In the course of a systematic follow-up examination without MRI the same 1000 patients (500     high-risk and 500 low-risk persons for cerebrovascular accidents) will be reinvited to the     sites. In addition to the standardized neurological and neuropsychological examinations a     surrogate parameter of nephropathy, microalbumin, will be examined as this parameter could be     helpful in forecasting cerebral microangiopathy. The clinical investigation will be expanded     by several tests in order to assess symptoms of cerebral microangiopathy.   "
250348|NCT01126788|"     This study is designed to test two hypotheses:        1. The PADnet+ testing system produces clinically equivalent results as the Parks Flo-Lab          testing system in a group of patients referred for evaluation of PAD of the limbs when          performed by a Registered Vascular Technologist (RVT).        2. The PADnet+ testing system produces clinically equivalent results when the testing is          repeated on the above patients and performed by staff specifically trained on the use of          the PADnet+ system but are not vascular technologists nor hold the RVT certification.   "
250349|NCT01126801|"     This protocol is a controlled study of estradiol therapy in early postmenopausal women with     and without frequent hot flashes that will be used to determine whether hot flashes are an     important intermediary in the generation of menopause-associated depression.   "
250350|NCT01126814|"     This is a Phase I-II study evaluating the toxicity and efficacy of imatinib combined with     mitoxantrone, etoposide and high-dose cytarabine reinduction therapy in relapsed and     refractory AML. Patients will be treated initially at a 200 mg dose of imatinib; if     tolerated, the imatinib dose will be escalated in subsequent cohorts to 300 mg and 400 mg.     Once the recommended dose is determined, the remaining patients will be treated at that dose,     to evaluate the antileukemic activity of the regimen. Patients achieving complete remission     will receive consolidation therapy with imatinib combined with high-dose cytarabine and     mitoxantrone, followed by maintenance imatinib.   "
250351|NCT01126827|"     The purpose of the study is to investigate the efficacy of mindfulness-based     cognitive-behavior therapy (MBCT) for improvement of symptoms associated with bipolar     disorder, by comparing MBCT to supportive psychotherapy. Patients who participate in this     study will be randomly assigned to receive either        1. state of the art group MBCT, or        2. supportive group psychotherapy (which is considered part of the standard care available          to patients at MGH).   "
250352|NCT01126840|"     Objectives:      Specific Aims:        1. Researchers will evaluate and compare predictors of health-related quality of life (QOL)          among colorectal cancer (CRC) survivors who have Lynch syndrome (LS) with those patients          who have sporadic CRC using both quantitative and qualitative methodology.           a. In both CRC groups, researchers will evaluate cancer preventive and health behaviors,          including lifestyle factors and screening, psychosocial factors, including mood, family          functioning, coping style, anxiety, depression, and social resources, and health care          system factors, including interactions with health care providers and service          utilization.        2. Researchers will compare the experience of first-degree relatives (FDRs) of patients who          have LS with that of FDRs of patients who have sporadic CRC using both quantitative and          qualitative methodology.           a. Researchers will evaluate all of the domains listed above, as well as anticipatory          grief, assessment of caregiving responsibilities, and fear of cancer in FDRs of patients          with LS-related and sporadic CRC.        3. Researchers will examine CRC patients from both groups and their FDRs using dyadic          analyses in order to evaluate the similarities and differences in their survivorship          experience.        4. Researchers will evaluate the preventive and health behavior of patients who are          non-conclusive for Lynch syndrome and their family members. They will examine their          screening behavior and will explore how the interaction between the patients and their          relatives affects the relatives' screening behavior. They also will examine how these          non conclusive LS patients and their family members perceive their risk for LS-related          cancers.   "
250353|NCT01126853|"     Hepatitis B is a vaccine preventable infection which can be transmitted through occupational     exposure. Approximately 15% of patients will not respond to an initial series of vaccination.     Of those re-vaccinated approximately fifty percent will respond. On the basis of poor     response to a third series, repeat vaccination is not recommended and non-responders are     considered vulnerable to infection. Cardell studied the use of double dose combination     hepatitis A and B vaccine (Twinrix) in non responders who had received four or more doses     previously and found a high response rate suggesting this vaccine and dose could be     effective. The investigators study seeks to duplicate the findings of Cardell, using a more     strict definition of non-responder (6 or more previous doses).   "
250354|NCT01126866|"     The purpose of this clinical trial is to primarily assess the efficacy of an intensified     chemotherapy consisting of a combination of FOLFOXIRI + bevacizumab. The main focus will be     laid on the rate of patients who achieve secondary complete (R0)-resectable metastases.      The FOLFIRI + bevacizumab as well as the FOLFOXIRI regimens have been shown previously to be     both effective in the treatment of advanced CRC with having manageable toxicities. Therefore,     an intensified chemotherapy combining these two standard regimens might be a promising     therapeutic approach improving the treatment of metastatic disease and outcome of CRC.      Patients with advanced colorectal carcinoma of UICC stage IV, and liver and/or lung     metasta¬ses only, which are not optimally resectable, will be enrolled in this single-arm     phase II study.      A minimum of 4 cycles (=8 weeks) of chemo¬therapy prior to surgery is mandatory for all     patients. However, patients may withdraw from the study at any time upon their own request.     Treatment with preoperative chemothera¬py will continue until 2-4 weeks prior to surgery with     the last application of bevacizumab (only FOLFOXIRI) 4 weeks before surgery, at longest 16     cycles (= 32 weeks) for candidates not eli¬gible for surgery. Treatment will be discontinued     prematurely at disease progression or unacceptable toxicity.      As secondary endpoints the acute and perioperative toxi¬city of preoperative chemotherapy     according to NCI CTCAE v 3.0 including all peri-and post-surgical complications as well as     progression free survival and overall survival and quality of life will be assessed.   "
250355|NCT01126879|"     RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.      PURPOSE: This randomized phase II trial is studying how well genistein works in treating     patients with prostate cancer.   "
250356|NCT01126892|"     A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in     blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and     efficacy of Nilotinib.   "
250357|NCT01126905|"     Anaemia is a common complication of Chronic Kidney Disease (CKD) the management of which has     been aided by the use of synthetic recombinant human erythropoietin therapy (r-HuEPO). This     red cell stimulating agent creates the further complication of Functional Iron Deficiency     (FID) where, despite normal iron stores, patients fail to respond to therapy as they do not     possess enough available iron to meet the demand of increased red cell production. Effective     response to r-HuEPO therapy depends on an appropriate monitoring of 'available' iron levels.      Previous research into the clinical utility of testing for reticulated haemoglobin     concentrations (Ret He) instead of Serum Ferritin and Transferrin Saturation analysis has     indicated an advantage as an iron deficient prognostic marker however, further knowledge is     required on the use of this new laboratory test (RetHe) to predict Functional Iron Deficiency     (FID) level and to study it's relationship with responses to therapy.      This proposed study aims to estimate a local working Normal (non deficient) and Iron     Deficient Reticulated Haemoglobin Content (RET He) reference range from surplus anonamous     samples. Routine monthly blood samples from Pre Dialysis and Haemodialysis patients will be     used to evaluate the sensitivity and specificity of the RET He test compared to current     laboratory tests and investigate its predictive ability for Functional Iron Deficiency in     these patients.      Studying , measuring and statistically analysing the change in the RET He parameters in     Haemodialysis and Pre Dialysis patients over 3 months will look for evidence of a direct     relationship between RET He values and the patients response to therapy. The data will be     used to provide a predictive picture of what levels of RET He indicate Functional Iron     Deficiency.      The introduction of this test (RetHe) may provide clinicians with a one sample/one test     control over iron therapies and ensure the patient gets the most benefit from erythropoietin     therapy.   "
250359|NCT01126931|"     Wormwood is approved herbal medicine for the treatment of reduced appetite in Germany     (Registration No.: 1339.99.99). Reduced appetite is observed in many chronic health disorders     such as old age, immune disorders and cancer.      Trial aims at observing beneficial effects of wormwood supplementation in various chronic     disorders associated with reduced appetite   "
250360|NCT01126944|"     The prognosis for heart failure patients is bleak for the advanced stages of the disease,     with a reported 6-month mortality rate of almost 50% in patients treated with chronic     inotropic therapy. As well as its very severe prognosis, heart failure is a costly disease.     Heart transplantation remains the reference treatment for the terminal stage of the disease     but although this is an effective therapy, it does engender ethical, social, economic and     legal problems. It also requires irreproachable and costly logistics, immuno-suppressor     treatment and a lifetime of follow-ups. In particular, the number of donors has been going     down steadily for several years in most countries which offer a heart transplant programme     and some patients cannot take advantage of being added to a waiting list for a graft (age,     co-morbidities…).      It is in this context that, alongside the medical treatments for cardiac insufficiency, other     therapeutic strategies were developed, including resynchronization and long-term mechanical     circulatory support. The progress made in resynchronization is at several levels: better     understanding of the action mechanisms, the development and improvement of equipment     specifically dedicated to resynchronization and prospective and randomized clinical trials     which have scientifically validated this technique.      Simultaneously, many studies were published evaluating long term support with mechanical     circulatory support (MCS), excluding light devices, as a bridge to transplant or an     alternative to a transplant. It is also recognized that mechanical circulatory support with a     new generation of continuous flow assist device improved the quality of life and functional     capacity, with a reduced risk of device failure and infrequent need for replacement.      The Achilles heel of cardiac resynchronization remains the 20 to 40% of patients who     respond barely or not at all. Among this population of patients, some are not candidates for     a transplantation and long-term mechanical circulatory support by axial pump is an     alternative to be considered. We elaborated an original randomized pilot study for these     patients in order to evaluate their survival and their quality of life, to define if they     should be proposed a left ventricular assist device (LVAD)or not.   "
250361|NCT01126957|"     Introduction      Numerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA)     in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics,     barbiturates, and others, but propofol has gained popularity despite its potential to cause     cardiac and respiratory depression. Obviously the optimal agent or combination of agents has     not been identified. There are reasons to believe that a combination of ketamine and propofol     may have advantages over other agents/combinations. These include better hemodynamic     stability at equal depth of anesthesia with a combination of ketamine/propofol than with     propofol alone, less respiratory depression with the combination in comparison to propofol     alone, and preservation of respiratory drive with the combination. There is one study of     ketamine/propofol in Emergency Department (ED) procedural sedation which demonstrated the     safety and effectiveness of the combination, but did not compare it to any other agents or     combinations. The investigators designed a randomized, placebo controlled study to compare     propofol to propofol and ketamine for adequacy of sedation and respiratory depression in     Emergency Department procedural sedation and analgesia. The investigators hypothesis was that     the combination of propofol/ketamine would produce better sedation and/or less respiratory     depression than propofol alone.      Methods      Study design      The investigators conducted a randomized, prospective, double-blinded study of all patients     receiving procedural sedation. From April 2007 until July 2009 in the ED of a 274 bed     university teaching hospital. The study was approved by the University of Missouri's     Institutional Review Board and informed consent was obtained from all participants.   "
250362|NCT01133223|"     Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be     achieved with different strategies - varying from intravenous rtPA from mechanical     thrombectomy. Recently, interventional approaches have been gaining attention and playing an     increasing role in stroke care. However, no solid scientifical data is available to date. The     investigators want do conduct a pilot trial to test if the use of the Penumbra™ System can     improve clinical outcomes in a specific stroke setting.   "
250363|NCT01133236|"     The non-pharmacological measures that are widely practiced and recommended for HF patients,     such as salt and water restriction, specially at moments of disease decompensation, still     lack clearer evidence of their therapeutic effect.   "
250364|NCT01133249|"     Objective      Describe the clinical and demographic characteristics of patients who undergo hip     arthroplasty and document post operative outcomes.      Examine the relationship between processes of care, hospital and surgeon associated outcomes      Provide expanded data to characterize existing and evolving practice patterns, delivery of     care, and resource utilization in the management of knee arthroplasty patients.      Analyze and design ancillary studies to address unanswered questions.      Disseminate findings through publication in peer-reviewed scientific journals.   "
250365|NCT01133262|"     We have developed a prototype PET insert device that can be integrated into a clinical     PET/computed tomography (CT) scanner to improve its image resolution to approximately 2.5 mm     in all 3 dimensions within a reduced imaging field of view (FOV). This zoom-in imaging     capability provides 6-fold improvement in volumetric image resolution over the current     state-of-the-art clinical PET scanner, offering a tremendous opportunity for cancer imaging     applications, in particular for those cases where a lymph node involvement will drastically     alter the patient management plan. Accurate diagnosis and staging of head-and-neck cancer is     known to be challenging because of the complex anatomy and large number of lymph nodes     involved in this region. As a result, head and neck cancer imaging is an ideal candidate for     evaluating the clinical usefulness of this novel imaging device.   "
250383|NCT01133496|"     The purpose of this study is to determine the bioequivalence of Alendronate Sodium 70 mg of     Dr. Reddy's and Fosamax Tablets 70 mg of Merck & Co.   "
250404|NCT01134250|"     This Phase Ib/II study is an open label, multicenter study.      The study is divided in two parts:      Phase I: an open-label, dose escalation study of F16IL2 in combination with paclitaxel for     patients with solid tumours, bladder cancer, breast cancer, metastatic melanoma,     mesothelioma, NSCLC, prostate cancer and sarcoma amenable to taxane therapy.      Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in     combination with paclitaxel, equivalent to stage 1 of the Simon two-stage phase II design,     for patients with metastatic melanoma, breast cancer and NSCLC amenable to taxane therapy.   "
250419|NCT01134445|"     The purpose of this study is to monitor the performance of the DePuy PROXIMA™ hip in the     treatment of patients with hip joint disease requiring a total hip replacement. Patients who     enter the study will be evaluated at regular intervals following hip surgery using patient,     clinical and x-ray assessments.   "
250366|NCT01133275|"     The purpose of this research is to evaluate the use of lenalidomide and prednisone in people     with Myelodysplastic Syndrome (MDS).      Lenalidomide is a drug that alters the immune system and it may also interfere with the     development of tiny blood vessels that help support tumor growth. Therefore, in theory, it     may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food     and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome     (MDS) and in combination with dexamethasone for people with multiple myeloma (MM) who have     received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being     tested in a variety of cancer conditions. As it is being used in this study it is considered     an investigational use. An investigational use is a use that is being tested and is not     approved by the FDA.      Prednisone is approved by the FDA to treat numerous conditions. In addition, prednisone is     approved by the FDA to treat Low or Intermediate-1 IPSS Risk, non-del (5q) MDS.      Study drug refers to the combination of lenalidomide and prednisone.   "
250367|NCT01133288|"     This study is to evaluate the safety of Yulex gloves when used by individuals who have     documented allergy to natural rubber latex from Hevea brasiliensis. Yulex is a latex from a     different plant (Guayule) and in previous studies shows no cross-reactivity to Hevea latex     and has not been allergenic in workers exposed to Yulex. The FDA has approved Yulex gloves     for use in the general population and has recognized and labeled these gloves as Hevea     Latex-free. The labeling still includes a precaution that Yulex gloves may pose a risk for     development of allergy because Yulex does contain a small amount of Guayule protein. Yulex     Corporation has proposed doing further studies to demonstrate safety and lack of     allergenicity in a population that is prone to latex allergy. In the proposed pilot study,     the investigators goal is to complete the protocol on 10 adults with spina bifida who are     allergic to natural rubber latex who will wear Yulex gloves as part of their regular bladder     and bowel care for approximately 30 minutes daily over a 3 month period. The investigators     anticipate that the investigators will need to recruit and enroll up to 50 study participants     to achieve a final sample of 10 adults with complete study data. Individuals with a history     of anaphylaxis will be excluded from the study. The study participants will be tested for     Yulex allergy by Glove Puncture Test as well as serology at the beginning and end of the     study. The FDA Devices group has reviewed the study design and agreed that this is a suitable     first pilot study.   "
250368|NCT01133301|"     Our study aims at contributing to a valid appraisal of the magnitude of naltrexone efficacy     as an antidissociative agent by using a double-blind randomized controlled trial.   "
250369|NCT01133314|"     The routine treatment of children with antimalarials will be monitored. Children with a     positive malaria film and/or a positive rapid diagnostic test (RDT) will have a capillary     blood sample taken to verify the diagnosis and to monitor the pattern of resistance.   "
250370|NCT01133327|"     The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used     in conjunction with the FilterWire Embolic protection system for treatment of patients that     suffer from carotid artery stenosis and that cannot have surgery due to high risk factors.   "
250371|NCT01133340|"     This study is looking for a better way to define rectal tumors undergoing pre-operative     radiation. MRI scanning generally results in more clear definition of the tumor that CT     scanning. Insertion of radio opaque clips in the tumor site could also help to visualize the     tumor better for radiotherapy treatment planning. The investigators believe both techniques     would help the physician to define to cancer better than using CT scan alone. The     investigators also will compare both techniques to define the better way to define the tumor.   "
250372|NCT01133353|"     The purpose of this clinical trial is to study the therapeutic effect of tetrabenazine MR in     children with Tourette's Syndrome, as measured by the improvement in total tic score of the     Yale Global Tic Severity Scale (YGTSS).   "
250373|NCT01133366|"     The purpose of this study is to assess how blood clotting and thinning time is effected when     a single dose of warfarin is given alone and when a single dose of warfarin is given with     mipomersen; to assess the blood levels of a single dose of warfarin, a single dose of     mipomersen, and a single dose of warfarin when given with mipomersen; and to assess the     safety of mipomersen when given with or without warfarin.   "
250374|NCT01133379|"     This study is for people with sensitive teeth and involves going to the dentist for 6 visits     over 8 weeks. During the first 2 weeks, everyone will just brush their teeth two times a day     with the fluoride toothpaste provided.      Then you will be assigned to a mouthwash group if you qualify to continue in the study. Two     groups will get mouthwash with a certain amount of an experimental ingredient and one group     will get a mouthwash with no experimental ingredients. You will have an equal chance of being     assigned to any one of the three groups.      For the next 6 weeks, you will rinse with your assigned mouthwash after brushing. A dentist     will look at your mouth, teeth, tongue and gums and check for sensitive teeth. The     investigators will see if the mouthwash helps to reduce tooth sensitivity during the study.   "
250375|NCT01133392|"     This study will compare how the body treats 2 different forms of insulin lispro and how they     affect blood sugar levels.   "
250376|NCT01133405|"     This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of     LY2886721 single doses, how the body handles the drug, and the drug's effect on the body.   "
250377|NCT01133418|"     Currently, only two treatment modalities for pediatric attention deficit hyperactivity     disorder (ADHD) are considered evidence-based: (1) pharmacological and (2) behavioral     treatment. Recently, several studies have shown promising results suggesting efficacy for     cognitive training interventions for children with ADHD. These interventions directly train     cognitive function (i.e., attention, working memory) by having children practice cognitive     skills using computerized tasks. In these studies, improvements related to the cognitive     training intervention have been documented on neuropsychological tests, academic tasks, and     parent ratings of children's ADHD behavior. Given the ubiquitous finding of increased     reaction time (RT) variability among children with ADHD, the candidate worked with a group of     developers to modify a cognitive training intervention to target RT variability. That is,     train the children to be less variable in their responding. Initial clinical data from this     intervention suggest that intervention exposure improves behavioral outcomes. However, an     appropriate powered randomized clinical trial is necessary to experimentally demonstrate     intervention efficacy.Sixty-four (64) children diagnosed with ADHD (either Predominantly     Inattentive Type or Combined Type) will be randomly assigned to intervention or control     conditions. Children in the intervention group will receive 8 weeks of the Computerized     Progressive Attention Training (CPAT) intervention. Children in the control group will     receive the CPAT intervention but there will be no progression in difficulty based on     performance as in the intervention group. Children in both groups will be assessed     pre-intervention and immediately after the 8-week training on neuropsychological, behavioral,     and academic outcome measures. Hypothesis-driven data analyses will assess intervention     efficacy.      Hypothesis #1: Children in the experimental group exposed to the CPAT intervention will show     greater improvement from pre- to post-intervention on neuropsychological tests compared to     children in the control group.      Hypothesis #2: Children in the experimental group exposed to the CPAT intervention will show     greater improvement from pre- to post-intervention on parent and teacher behavioral ratings     of ADHD behavior compared to children in the control group.      Hypothesis #3: Children in the experimental group exposed to the CPAT intervention will show     greater improvement from pre- to post-intervention on academic outcomes compared to children     in the control group.   "
250384|NCT01133509|"     In this pilot study, we intend to demonstrate that a great portion of women at high risk     (inadequate screening, HPV 16/18 and/or cytology) are presenting to the ED, cytology/ HPV     testing via ThinPrep®Pap testTM and surveillance. We intend to provide improved access to     healthcare and monitoring through administration of vaccine to eligible patients and 1 year     follow up for patients involved in this study.      Females meeting inclusion/exclusion criteria participating in the study (n=100) that have not     had a cytology test in 2 or more years will be offered the Thin Prep® cytology test. This     study will allow surveillance of disease through cytology and HPV DNA testing via collection     of data using Thin Prep® cytology with reflex HPV DNA testing according to established     guidelines as described below.      Provide improved access to healthcare and monitoring through administration of vaccine for     eligible females as established by guidelines. Patients will receive first vaccine in the ED     and will have arranged follow up for administration of the 2 month and 6 month series of the     HPV vaccination. Through data collection, we intend to determine if there is a need for     vaccination and determine if patients are likely to follow up..   "
250385|NCT01133522|"     The purpose of the study is to evaluate the safety and tolerability of multiple doses of     evolocumab when given as an add-on to stable statin therapy.   "
250386|NCT01133535|"     The purpose of this study is to collect standardized data on the diagnosis and management of     idiopathic (unknown cause) recurrent acute pancreatitis. The intent is to collect data for at     least five years to obtain information regarding long-term outcomes and obtain comparative     effectiveness data.   "
250387|NCT01133548|"     To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption     in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper     arms/shoulders using an application site rotation or a combination of application sites.   "
250388|NCT01134042|"     The purpose of the study is to compare the efficacy and safety of fluticasone     furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with     fluticasone furoate inhalation powder administered alone once daily each evening in     adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over     a 24-week period.   "
250389|NCT01134055|"     The purpose of this study is to determine the safety and efficacy of different dosage     regimens of pazopanib eye drops for the treatment of neovascular age-related macular     degeneration.   "
250390|NCT01134068|"     Suspected pulmonary embolism (PE) is a frequent clinical problem and remains a diagnostic     challenge. The diagnostic approach of PE relies on sequential diagnostic tests, such as     plasma D-dimer measurement, multi-slice computed tomography (MSCT) and pulmonary angiography.     In addition, the diagnostic workup is usually stratified according to the clinical     probability of pulmonary embolism. Clinical probability has a fair predictive accuracy either     evaluated implicitly or by clinical prediction rules1 and is useful for identifying patients     with a low prevalence of pulmonary embolism who can be usually fully investigated by non     invasive tests.The D-dimer test has been extensively evaluated in the exclusion of pulmonary     embolism, particularly in outpatients. ELISA D-dimer and second-generation latex     agglutination (immuno-turbidimetric tests) have a remarkably high sensitivity and have been     proved safe first-line tests in association with clinical probability to rule out pulmonary     embolism in outcome studies. The clinical usefulness of D-dimer is defined by the proportion     of patients in whom pulmonary embolism may be ruled out by a normal result and it is     determined by the specificity. However, ELISA and second-generation latex agglutination     (immuno-turbidimetric tests) tests have a quite limited overall specificity of around 35% to     40%. Therefore, many investigators tried to increase the D-dimer thresholds in particular in     elderly patients to increase the rate of patients in whom the diagnosis could be excluded by     this easy and inexpensive test. Several studies have shown that D-dimer levels increase with     age and which turns in a decreased specificity of the D-dimer test at the usual threshold in     the elderly, and thus to a less useful test to exclude PE in older patients. Indeed, ELISA     D-dimer is able to rule out PE in 60% of patients aged less than 40 years, but in only 5% of     patients above the age of 80.8 In this study, raising the cut-off value to various points     between 600 ng/ml and 1000 ng/ml increased specificity, but this came at the cost of safety     with more false negative test results. In this analysis, however, no stratification was made     for clinical probability and the sample was small.      Recently, the investigators retrospectively assessed the value of a progressive cut-off     adjusted to age in a wide sample of 1712 patients. This new cut-off was defined for D-Dimer     test positivity in each patient by multiplying patient's age by 10. All patients with a     D-Dimer level below 500mg/ml, and all patients above 50 years whose D-Dimer levels were     inferior to their age multiplied by 10 were considered as having a negative D-Dimer test. The     exact derivation and validation of this new D-dimer cut-off is described hereafter. Using     the conventional cutoff, the VIDAS® D-Dimer test was negative (below 500 mg/ml) in 512/1712     patients (29.9%) and none had PE during initial workup or the three-month follow-up period.      Using the cutoff adjusted to age (cutoff for D-Dimer test positivity equals age multiplied by     ten, in mg/ml), the figure was as follows. D-Dimer levels were below the adjusted cutoff in     615/1712 patients (35.9%, number needed to test 2.8). This represented a statistically     significant 20.1% increase in the number of patients in whom the D-Dimer test was considered     as negative, p=0.0002. Of these 615 patients, 5 had PE during initial workup (0.8%, 95     percent confidence interval 0.4 to 1.9%).      These data suggest that adopting this progressive cut-off in patients above 50 years, could     increase of about 20% the number of patients in whom PE could be excluded without further     testing, with an acceptable safety profile as the three-month thromboembolic rate remained     very low.      Therefore, the investigators plan a prospective outcome study in which this progressive or     new cut-off (age X 10 ng/ml) in patients above 50 years will be used. In this multicentre     study, clinical probability will be assessed by the simplified revised Geneva revised score     (Table 1) and an ELISA D-dimer test will be performed [Vidas D-Dimer Exclusion® test     (Biomérieux, Marcy l'Etoile, Paris, France)]. Patients with a non high clinical probability     with the simplified revised Geneva score and a normal new D-dimer cut-off with the Vidas     D-dimer Exclusion®, (Biomerieux, Marcy l'Etoile, France) will be considered as not having PE,     and will be followed for three-months to assess possible VTE recurrences. The main outcome     will be the rate of thromboembolic events during a formal 3-month follow-up in patients not     anticoagulated on the basis of this strategy. Patients with positive D-dimers will be     investigated with MSCT as currently admitted.   "
250391|NCT01134081|"     The purpose of this observational research study is to understand more about wound healing of     gum tissue. This study was the biomarker study of a small cohort of study participants     derived from NCT01547962 (completed). Two surgical sites of each patient were randomly     selected to receive CelTx™ as a donor material in one site and conventional autograft using     keratinized tissue from the palate as the donor material at the contralateral (opposite side)     site. Fluids collected from between a tooth and the gum and directly from wounds contain     proteins that occur in different levels as the wound healing process proceeds. In this     research study wound fluid will be collected from the donor palate site (roof of your mouth)     and the treated sites on your gum before and after placement of CelTx and conventional     treatment (tissue from the roof of your mouth) to measure which proteins and how much of each     are present during the first 4 weeks of wound healing.   "
250392|NCT01134094|"     This study will determine whether operative management confers improved short and long−term     outcomes for patients with isolated AO type 44−B1 distal fibula fractures when compared with     non−operative management.   "
250393|NCT01134107|"     Patients will continue to use their current insulin pump for this study. Patients will     receive insulin lispro and insulin aspart during this study. One medication will be taken for     12 weeks and then the other medication for 12 weeks. Neither the patient nor the study doctor     will know which medication is being taken at any time. The order in which the two medications     are taken will be determined by chance.   "
250394|NCT01134120|"     The purpose of this study is to find out the safe dose range of the study drug in patients     with myeloproliferative disorders.   "
250395|NCT01134133|"     Hospital inpatients who have gurgling sounds heard during speech or breathing have been     observed to have a higher risk of hospital acquired pneumonia. Patients who gurgle and who     consent to participation will be randomized to receive routine clinical management or     management to include measures employed to reduce risks of aspiration, namely, 1. head of bed     up (30 degrees or higher), 2. swallowing evaluation by speech therapist (and feeding     predicated on formal evaluation), 3. prompting managing physicians to reduce sedating     medications to minimal effective dose.   "
250396|NCT01134146|"     The goal of this clinical research study is to find the highest tolerable dose of radiation     that can be given to directly to the pleura (the outer lining of the lungs) using intensity     modulated radiation therapy (IMRT) in patients with MM who have had a pleurectomy.   "
250397|NCT01134159|"     Multicenter, retrospective registry to collect 9-12 month follow-up data to evaluate major     adverse cardiac events in patients whom have undergone percutaneous coronary intervention and     received either Taxus Liberte or Xience V.   "
250398|NCT01134172|"     The purpose of this study is to learn more about how being treated for breast cancer affects     patients' employment, financial situation, and quality of life on a short-term basis and on a     longterm basis. Most studies of employment after breast cancer have focused on Caucasian     women.This study will evaluate the impact of breast cancer on the lives of women from     different ethnic groups.   "
250399|NCT01134185|"     This is a single centre, open-label phase I trial to investigate the effects of moderate to     severe hepatic impairment on the pharmacokinetics of prucalopride in comparison with healthy     volunteers. Furthermore the short-term safety and tolerability of a single dose of     prucalopride will be assessed.   "
250400|NCT01134198|"     This research will evaluate the impact of blocking central and peripheral glucocorticoid     receptors on stress sensitivity and the risk of relapse to cocaine use in treatment-seeking     cocaine-dependent individuals. Mifepristone (RU-486) will be the glucocorticoid antagonist     used.   "
250401|NCT01134211|"     The primary objective of this trial is to evaluate the subjective performance of two     different daily disposable contact lenses in a population of daily disposable lens wearers.   "
250449|NCT01134835|"     To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the     treatment of asthma.   "
250405|NCT01134263|"     The purpose of this study is to demonstrate that different CYD Dengue vaccine lots     manufactured using the same method and in the same location but at different times produce an     equivalent immunological response.      Primary Objective        -  To demonstrate that three different Phase III lots of CYD Dengue vaccine induce an          equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against          the four parental serotypes.      Secondary Objectives:        -  To demonstrate that data from one Phase II lot and pooled data from Phase III lots of          CYD Dengue vaccine show an equivalent immune response in terms of post-Dose 3 GMTs          against the four parental serotypes.        -  To describe the safety (in terms of solicited injection site and systemic reactions and          unsolicited adverse events) of the CYD Dengue vaccine in all subjects after each dose.   "
250406|NCT01134276|"     Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage     (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage     (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase     difficulties in determining a proper resection margin. The purpose of this study is to     compare the clinicopathological outcomes according to the methods of preoperative biliary     drainage in periampullary cancers causing obstructive jaundice, and to find out a proper     biliary drainage method.   "
250407|NCT01134289|"     This study aims to compare the alternative current and the direct current signal changes of     photoplethysmography between both feet during one side lumbar sympathetic block.      The hypothesis is that signal changes occur earlier than other indices to decide whether it     is successful following lumbar sympathetic block on only one-side.   "
250408|NCT01134302|"     The purpose of this trial is to determine, at 3 years of life, how the neurologic and     functional outcomes in infants with single ventricles are different when comparing children     treated with the Hybrid strategy to the Norwood strategy.   "
250409|NCT01134315|"     The objective of this study was to observe the safety of paricalcitol utilization in     pediatric participants (ages 0 to 16 years old) being treated for secondary     hyperparathyroidism (SHPT). Participants were to be followed for a minimum of 3 months and up     to approximately 36 months to monitor the incidence of hypercalcemia (high calcium levels in     blood).   "
250410|NCT01134328|"     The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its     components in the prevention of the signs and symptoms of allergic conjunctivitis in     Enviro-CAC™ Model.   "
250411|NCT01134341|"     This study is designed to determine the recommended dose, safety, pharmacokinetics, and early     efficacy of the combination of pralatrexate plus oral bexarotene in patients with relapsed or     refractory CTCL.   "
250412|NCT01134354|"     Design:      Prediction trial, up to 10 sites in Asia and Europe      Goal:      To better understand the success or failure after orthopedic trauma surgery by developing     a model that can be applied clinically as a user-friendly baseline questionnaire - capable     of predicting success or failure based on a patient's pre-surgical expectations of their     final outcome and to validate a novel outcomes measure (TOM).      Primary aim:      To assess the psychometric properties of predictive validity, internal consistency and     reproducibility of the trauma expectation factor (TEF) in the Eurasian population.      Secondary aim:      To assess the psychometric properties of criterion validity, internal     consistency,reproducibility, and sensitivity to change of the TOM in the Eurasian population.      Key questions related to patient and surgeon expectations:        -  How different, or similar, are patient and surgeon expectations?        -  Do expectations change over time?        -  Do patient expectations predict outcomes in validated measures use today?   "
250413|NCT01134367|"     The purpose of this study is to examine patient's perspective of symptom control and impact     of gastroesophageal reflux disease (GERD) on daily life.   "
250414|NCT01134380|"     The objective of GIANT Study is to evaluate the clinical impact of genetic resistance to     thienopyridine profile determination (CYP2C19 gene) and the clinical impact of compliance to     an adjusted thienopyridine treatment on STEMI patients treated by primary PCI within the 24     hours following the first chest pain.   "
250415|NCT01134393|"     The general aim of this trial to determine the efficacy as measured by the percentage of     patients reaching blood pressure goal at the end of the treatment period at 12 weeks.     In-clinic blood pressures, home blood pressures and safety will be carefully monitored.   "
250416|NCT01134406|"     The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy     (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) for treatment of pain from osteoarthritis of     the knee, in patients who have failed to respond adequately to conservative non-pharmacologic     therapy and simple analgesics.   "
250417|NCT01134419|"     The investigators propose to test the hypothesis that implementation of a comprehensive     handoff program (CHP) - i.e., implementation of a computerized handoff tool along with     teamwork training for pediatric residents on inpatient units at Children's Hospital Boston -     will lead to reductions in resident miscommunications / medical errors and improvements in     workflow and experience on the wards.   "
250418|NCT01134432|"     The conventional treatment in warm-antibody dependent autoimmune haemolytic anaemia (AIHA) is     high-dose glucocorticoid, but in more than half of the patients, haemolytic activity will     recur after end of treatment or during the gradual reduction in dose of the drug. As a     result, many patients will finally be splenectomized or be treated with long-term     glucocorticoids or other immunosuppressive drugs as azathioprine or cyclophosphamide. Recent     studies have shown however, that some patients will respond to treatment with the chimeric     anti-CD 20 antibody Rituximab and is some cases, the response is permanent. In most of the     studies, Rituximab has been used in refractory disease or at least as second line treatment.     In this study, patients with AIHA are randomized to receive either high-dose prednisolone     with gradual reduction in dose over 2-3 months alone or in combination with Rituximab 375     mg/m2 once a week for 4 weeks. The efficacy of Rituximab will be evaluated by a comparison of     the patients in the two treatment arms. The primary treatment goal is a reduction in the     number of patients who obtain long-term complete or partial remission. The secondary     treatment goal is a reduction in patients who will be splenectomised or receive other     immunosuppressive drugs. Finally a comparison of side effects of the treatments will take     place.   "
250420|NCT01134458|"     The investigators propose an evaluation that will assess three important components of risk     communication:        1. provide patients with personalized risk communication using the risk calculator          developed by FIMDM and health information taken from the Living with Coronary Artery          Disease program        2. provide personalized tailored patient feedback to help initiate and maintain specific          cardiovascular CVD-related behaviors(e.g., medication adherence, exercise, diet, smoking          cessation) to reduce their risks.        3. evaluate how this feedback can be incorporated into clinical care by examining 3 month          patient outcome and provider responses to the risk information.   "
250421|NCT01134471|"     The purpose of this study is to compare 2 different hemostatic agents (Bonewax and Ostene)to     a control group with regards to bleeding, bone healing, pain and infection in a patient group     all undergoing median sternotomy.   "
250422|NCT01134484|"     Thalidomide-Dexamethasone (TD) is a standard induction therapy for Multiple Myeloma (MM). The     present study is designed to compare TD with VELCADE-Thalidomide-Dexamethasone (VTD) as     induction therapy in preparation for, and as consolidation after, melphalan-based double     autologous stem cell transplantation for previously untreated patients aged ≤65 years with     symptomatic MM. Primary study endpoint is the rate of complete response (CR) plus     near-complete response (nCR) to induction treatment. Secondary endpoints include the rate of     CR plus nCR to double transplantation and subsequent consolidation therapy, time to     progression (TTP), progression-free survival (PFS),overall survival (OS) and toxicity profile     of both VTD and TD.   "
250423|NCT01134497|"     In this randomised Phase II trial all patients will receive carboplatin, with half randomly     selected to receive ZD4054. The other half to also receive a dummy pill or placebo, this is     so that we can accurately assess how much extra benefit ZD4054 may give. The trial will     recruit 132 patients with metastatic breast cancer from across the UK and assess whether     adding ZD4054 to carboplatin delays progression of their disease. It will also show whether     the side effects of adding ZD4054 to carboplatin chemotherapy are acceptable.      Because ZD4054 has not previously been given with carboplatin to this population, in Stage 1     of the study 6 patients will receive ZD4054 with carboplatin. If there are no untoward side     effects with carboplatin and ZD4054 then the trial will proceed to Stage 2 and a further 126     patients will be randomised to receive carboplatin with either ZD4054 or the placebo; neither     the patient nor their doctor will know whether she is receiving ZD4054 or placebo.   "
250424|NCT01134510|"     Organ transplantation offers the only hope for a normal life for patients with end-stage     renal disease on dialysis (ESRD). For the highly-sensitized patient, patients with antibodies     to human leukocyte antigens (HLA), transplantation is extremely difficult or impossible since     pre-formed antibodies will cause severe rejection and loss of transplanted organs.     Approximately 30% of the transplant list in the U.S. is considered sensitized (have     detectable antibodies to HLA antigens). These anti-HLA (anti-Human Leukocyte Antigen     antibodies) pose a significant barrier to transplantation that has recently been successfully     addressed using desensitization therapies with IVIG, rituximab and/or plasmapheresis (PE).     Despite the success of these therapies, post-transplant antibody mediated rejection (AMR) and     chronic Antibody Mediated Rejection (CAMR) remain significant problems. Recent data suggests     that addition of Berinert (C1 Inhibitor) to post-transplant treatment regimen may     significantly reduce incidence of Antibody Mediation Rejection.      Twenty highly-sensitized patients who have undergone desensitization treatment and are     awaiting kidney transplant will be enrolled in the study. Once transplanted these patients     will be started on the standard of care post-transplant immunosuppressive protocol. In     addition patients will receive Berinert 20 units/ kg daily x 3 days, then twice weekly x 3     weeks. At the end of Berinert treatment a kidney biopsy will be performed. Subjects will be     followed for 6 months to assess safety and efficacy of the study protocol.   "
250425|NCT01134523|"     To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast     cancer patients with positive lymph nodes   "
250426|NCT01134536|"     The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and     tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and     adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical     pain.   "
250427|NCT01134549|"     The purpose of this study is to characterize the safety and tolerability of etelcalcetide in     healthy young males.   "
250428|NCT01134562|"     The purpose of this study is to characterize the safety and tolerability of single rising     doses of KAI-4169 in hemodialysis subjects with secondary hyperparathyroidism.   "
250429|NCT01134575|"     The goal of this clinical research study is to learn if CMC-544 given alone, and possibly     given in combination with rituximab, can help to control the disease in patients with ALL.     The safety of the study drug(s) will also be studied.   "
250430|NCT01134588|"     The purpose of this study is to compare the touch-screen version of the PFDI-20, PFIQ-7, PISQ     12 and SF-36 french questionnaires to their paper versions. The investigators hypothesize     that the percentage of completely filled questionnaires will be higher in the touch-screen     version.   "
250431|NCT01134601|"     Background:      - The investigational anti-cancer drug AZD6244 prevents a protein found in rectal cancer from     working properly, which may slow tumor growth and allow radiation and chemotherapy treatments     to destroy more cancer cells. Researchers are interested in determining whether AZD6244 can     be used to improve treatment outcomes in individuals who have rectal cancer that has spread     outside the rectum into the surrounding pelvis.      Objectives:      - To determine safe and effective doses of AZD6244, along with radiation and chemotherapy, to     treat rectal cancer.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with rectal cancer that has     spread outside the inner wall of the rectum or into lymph nodes in the pelvis.      Design:        -  Eligible participants will be screened with a physical examination, blood and tumor          samples, and imaging studies.        -  Participants will receive AZD6244 twice a day by mouth for 1 full week (7 days) before          starting radiation and chemotherapy and every week thereafter until the end of the          radiation and chemotherapy treatment.        -  Participants will have radiation therapy daily, 5 days per week, for approximately 6          weeks.        -  Participants will receive chemotherapy (capecitabine) twice daily, 5 days per week, for          approximately 6 weeks.        -  Approximately 4 to 8 weeks after completing the AZD6244, radiation, and chemotherapy          treatment, participants may have surgery to remove any tumors and affected lymph nodes.          This surgery is not part of the treatment delivered on this protocol.        -  Participants will have a follow-up exam 3 weeks after the end of treatment, every 3          months for the first year, and then in the second and third year after the end of          treatment. These visits will involve a full medical examination and imaging studies.   "
250459|NCT01134965|"     The aim of this trial is to investigate the effect of multiple doses of flibanserin on the     single dose pharmacokinetics of digoxin in healthy female and male volunteers. Digoxin is a     narrow therapeutic index drug for which a large number of relevant drug-drug interactions are     known. Flibanserin is now under evaluation in postmenopausal women which increases the     likelihood that flibanserin and digoxin will be administered together in the clinical     setting.   "
250432|NCT01134614|"     This randomized phase II trial is studying how well giving ipilimumab with or without     sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that     cannot be removed by surgery. Ipilimumab works by activating the patient's immune system to     fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of     immune cells found in bone marrow or peripheral blood and may help the immune system recover     from the side effects of treatment. It is not yet known whether giving ipilimumab together     with sargramostim is more effective than ipilimumab alone in treating melanoma.   "
250433|NCT01134627|"     This is a multicentric, double-blind, placebo-controlled, randomized, parallel group study to     estimate the effect of minocycline as add-on to interferon beta-1a (IFN beta-1a) in subjects     with relapsing-remitting multiple sclerosis (RRMS).   "
250434|NCT01134640|"     A post marketing surveillance, prospective study to collect safety information from 250     subjects with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type metastatic     colorectal cancer treated with Erbitux as final evaluable cases.   "
250435|NCT01134653|"     Acute ankle sprain is one of the most common musculoskeletal injuries, accounting for an     estimated 2 million injuries per year and 20% of all sports injuries in the United States.     Ankle sprains can lead to prolonged periods of pain, difficulty with mobility, and lost work     or play time. Current best practice guidelines for treatment of an acute ankle sprain are     protection, rest, ice, compression and elevation (PRICE). However recent systematic reviews     for ankle sprains call into question this treatment. Two critical components; immobilization     and ice, have little or no evidence of efficacy for ankle sprain. Interestingly, mobilization     appears to be more effective at reducing the pain, swelling and stiffness of musculoskeletal     injuries including ankle sprains. Historically the limitation to early mobilization has been     pain. Recently developed stretch bands have been introduced to the therapy market as a tool     that allows pain-free active and resisted ankle movement after acute ankle sprain.      The investigators propose a double blind randomized controlled study to compare 2 ankle     sprain treatments on their ability to speed recovery and reduce morbidities such as pain,     swelling and weakness.   "
250436|NCT01134666|"     This is an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating     FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type     metastatic CRC.   "
250437|NCT01134679|"     The purpose of this study is to test the impact of a multidisciplinary approach to improve     the adhesion and persistence to Clopidogrel therapy. A simple and inexpensive therapy     management involving a tighter monitoring of patients by nurses and pharmacists will improve     the persistence and adhesion to Clopidogrel and Aspirin after the implantation of     drug-eluting stents.   "
250438|NCT01134692|"     Chronic peripheral and splanchnic vasodilatation are the hallmark hemodynamic abnormality in     cirrhosis and contribute to the pathogenesis of portal hypertension.      Alterations in intestinal motility and bacterial overgrowth in gut may predispose to the     development of bacteraemia and endotoxaemia in cirrhotic patients which play a role in the     hyperdynamic circulatory syndrome of cirrhosis. Probiotic therapy is aimed at changing the     make-up of the indigenous microflora by administering specific strains of non-pathogenic and     potentially beneficial microflora. In this study, the investigators hypothesize that a     modification in the composition of the endogenous digestive microflora by oral     bacteriotherapy with high potency probiotic preparations could be a safe way to regulate the     portal pressure.      As there is a relative paucity in effective pharmacological treatment for portal     hypertension, these novel and innovative therapy might provide important alternative or     adjunct therapy to beta blockers in the clinical management of patients with portal     hypertension.      Aims and objectives      To study in patients with cirrhosis and large varices whether probiotics and/or norfloxacin     given for 2 months :        1. achieve a reduction in HVPG        2. alter the endotoxin and cytokine levels, and improve systemic inflammatory responses        3. well tolerated.      Inclusion criteria:      Consecutive patients of cirrhosis with portal hypertension who fulfill the following     criteria:        1. Diagnosed cases of cirrhosis (by clinical, biochemical and radiological criteria with or          without liver biopsy)        2. No history of upper GI bleeding in the past        3. Endoscopically documented large esophageal varices      Exclusion criteria        1. history of gastrointestinal bleeding        2. patients who have received beta blockers for portal hypertension in the past 6 weeks.        3. hepatic encephalopathy        4. ongoing bacterial infection,        5. Spontaneous bacterial peritonitis        6. active alcoholism or illicit drug abuse        7. alcoholic hepatitis        8. Treatment with antibiotics in the preceding 2 weeks.        9. presence of hepatocellular carcinoma,       10. portal vein thrombosis       11. serum creatinine>1.5 mg/dL,       12. treatment with vasoactive drugs in the past 6 weeks,       13. history of arterial hypertension, congestive heart failure or arterial occlusive          disease, and       14. Refusal to participate.       15. Active smokers.      Study plan:      Ethical approval will be obtained prior to study initiation. Patients presenting to     Department of Gastroenterology, GB Pant Hospital will be recruited in the study. Patients     will be evaluated regarding the eligibility for the study. After being found eligible for the     study, if the patient agrees to participate in the study, a signed informed consent will be     obtained. Baseline HVPG will be measured in all patients and then they will be randomized     into 3 groups:.        1. Group 1: Beta blockers + placebo        2. Group 2: Beta blockers + Norfloxacin (400mg BD)        3. Group 3: Beta blockers + probiotics. (one sachet of VSL#3 BD)      30 patients will be enrolled into each group. The treatment will be continued for 2 months.      The study design is a randomized double-blinded placebo controlled trial.      Once patients have been enrolled, they will undergo baseline investigations. Blood will be     drawn from both peripheral and hepatic veins and sent for routine parameters,     pro-inflammatory cytokines (IL-1b, IL-6, IL-10, TNF-α, endotoxins, NO2 and NO3 levels, PRA,     BNP). Samples will be stored at -70 ºC. Baseline vitals will be recorded.      Patients will be called at the end of 1 month for assessment of compliance and then at the     end of the study (2 months) to repeat the HVPG and the same parameters as at the time of     enrollment      End Points:        1. Primary           a. Change in HVPG levels as compared with baseline, to define responder (≥20% reduction          in HVPG or ≤ 12 mm Hg).        2. Secondary             1. Change in digestive flora             2. Reduction in serum and hepatic endotoxin and cytokine levels             3. Assessment of improvement in the renal parameters and Systemic inflammatory               response syndrome             4. Improvement in the markers of oxidative injury             5. Adverse effects   "
250439|NCT01134705|"     The purpose of the study is to assess the efficacy and safety of an investigational nasal     aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.   "
250440|NCT01134718|"     The purpose of this study is to compare in healthy volunteers levels of TMC435 in the blood     circulation after intake of 2 new capsule formulations with the level of TMC435 in the blood     circulation after intake of the capsule formulation used in the Phase IIb studies.   "
250441|NCT01134731|"     The study aims to use a combined clinical and translational approach to identify an efficient     pharmacotherapy for the acute management of suicidality and the epigenetic regulation     associated with the treatment.The primary objective is a clinical trial to compare the     efficacy of paliperidone versus lithium and placebo as adjunctive therapy to the standard of     care antidepressants in the acute management of suicidality in depressed subjects.      Specific Aims 1 and 2 are described in detail below. Analysis for Specific Aim 2 is still     underway.   "
250442|NCT01134744|"     The purpose of this study is to identify the clinical criteria for requesting a chest x-ray     in a patient with blunt trauma and its findings such as clinical signs with a high     sensitivity could be used in a larger study to codify the final criteria.   "
250443|NCT01134757|"     The present study is aimed to evaluate a bronchial allergen challenge with house dust mite     and alternaria. Firstly, the years 2005, 2006, 2007, 2008 and 2009 will be retrospectively     reviewed. Secondly, in 2010-2013, in the prospective part of the study the patients will     undergo the bronchial allergen challenge to examine safety of the bronchial allergen     challenge and change of allergen specific bronchial hyperreactivity before and after allergen     specific immunotherapy.   "
250444|NCT01134770|"     The purpose of the study is to understand the biology and behavior of early mother-infant     attachment, and to investigate how it may be affected by prenatal substance exposures. The     investigators are interested in how drugs such as cocaine, alcohol, marijuana and cigarette     smoking affect both mother and baby.   "
250445|NCT01134783|"     Examine the effectiveness of a weight gain prevention intervention to positively affect body     mass index in 2-year college students   "
250446|NCT01134796|"     Assessment of a custom made grasp device in the rehabilitation of stroke victims.   "
250447|NCT01134809|"     Background: Skeletal muscle wasting or decrease in muscle mass occurs as a result of     alteration in the body's mechanisms to make or break muscle protein. In animal models, the     pathway termed as 'ubiquitin-proteasome pathway' (UPP) is primarily responsible for the     regulation of skeletal muscle protein loss in wasting conditions and during     infection(sepsis). Skeletal muscle wasting is noticed in patients having major surgery due to     the inflammatory reaction triggered by special group of proteins called cytokines     (inflammatory proteins), resulting in reduced muscle strength, impaired capacity to fight     infections, change in bowel function, increased clinical complications and prolonged     recovery. Major surgery also leads to decreased sensitivity to hormone known as insulin,     resulting in 'diabeteslike'state.      We hypothesize that susceptibility of patients undergoing major abdominal surgery, to     skeletal muscle wasting and insulin resistance, is determined by stress response to surgery     over time, leading to changes in the pathways that make or break muscle protein, namely the     Akt/Foxo signalling and UPP. Therefore, the aim of this study is to establish the underlying     mechanisms of skeletal muscle wasting and insulin resistance in patients undergoing major     abdominal surgery.   "
250448|NCT01134822|"     The overall aim of this study is to develop a test that predicts the prognosis of IPF     (Idiopathic Pulmonary Fibrosis) and which could be used to determine whether new treatments     for IPF are likely to work.   "
250450|NCT01134848|"     The sphincter of Oddi is a circular band of muscle which controls the flow of pancreatic     juices and bile into the small intestine. Abnormal function of the Sphincter of Oddi, known     as Sphincter of Oddi dysfunction (SOD), can lead to recurrent episodes of abdominal pain.     Making a diagnosis of SOD is difficult and is currently achieved using an invasive pressure     test. This pressure test is associated with some adverse effects including inflammation of     the pancreas gland. We are investigating an alternative test in which medication is given to     provoke spasm of the sphincter. Following provocation, blood can be sampled to detect changes     in blood composition and changes in sphincter anatomy can be evaluated using specialized     imaging techniques.      Our aim is to study and compare the effects of two provocation medications     (morphine-prostigmine and secretin) on biliary and pancreatic ductal anatomy, using dynamic     serial MRCP in healthy volunteers.      Our hypothesis is that morphine-neostigmine provocation results in greater changes in biliary     and pancreatic ductal anatomy when assessed using dynamic serial MRCP.   "
250451|NCT01134861|"     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so     they stop growing or die. Combining more than one drug and combining chemotherapy with     radiation therapy may kill more tumor cells.      PURPOSE: Randomized phase III trial to compare the effectiveness of various schedules of     radiation therapy and combination chemotherapy using vinblastine and cisplatin or cisplatin     and etoposide in treating patients with stage II or stage III non-small cell lung cancer that     cannot be removed surgically.   "
250452|NCT01134874|"     The primary aim of this study is to compare the changes in body weight between a     technology-based system, an in-person behavioral weight loss intervention, and a combination     of both during a 12 month behavioral weight loss intervention in adults. Sedentary, healthy     overweight and obese adults will be recruited to participate. Assessments will be conducted     at 0, 6, and 12 months. This is a randomized trial in which participants will be randomized     to one of three groups: standard behavioral weight loss (SBWL), standard behavioral weight     loss plus technology (SBWL+TECH), and technology alone alone (TECH).   "
250453|NCT01134887|"     This randomized control study tested the feasibility of two communication enhancement     interventions: one with veterans who had a stroke and demonstrated poorly controlled     hypertension; the other with VA primary care providers who provided routine outpatient     medical care to these veterans. This study intervened with both members of the     provider-patient dyad in an attempt to improve the self-management of hypertension by     improving communication during visits to the VA outpatient clinic, specifically by enabling     veterans to communicate their questions and concerns about chronic disease self-management to     their providers more effectively, and to help providers improve their ability to communicate     more effectively with this population of veterans.   "
250454|NCT01134900|"     The utilization of clinical decision support (CDS) is increasing among healthcare facilities     which have implemented computerized physician order entry or electronic medical records.     Formal prospective evaluation of CDS implementations occurs rarely, and misuse or flaws in     system design are often unrecognized. Retrospective review can identify failures but is too     late to make critical corrections or initiate redesign efforts. A real-time surveillance     dashboard for high-alert medications integrates externalized CDS interactions with relevant     medication ordering, administration, and therapeutic monitoring data. The surveillance view     of the dashboard displays all currently admitted, eligible patients and provides brief     demographics with triggering order, laboratory, and CDS failure data to allow prioritization     of high-risk scenarios. The patient detail view displays a detailed timeline of orders, order     administrations, laboratory values, and CDS interactions for an individual patient and allows     users to understand provider actions and patient condition changes occurring in conjunction     with CDS failures. Clinical pharmacists' use of the dashboard for patient monitoring and     intervention aims to increase the rate and timeliness of intercepted medication errors     compared to CPOE-based CDS in the setting of acute kidney injury, which affects patients at     various points across all hospital units and services and has numerous opportunities for     intervention.   "
250455|NCT01134913|"     This is a prospective clinical study designed to procure blood samples from patients who     present to the Emergency Department with suspected ACS (Acute Coronary Syndrome).      Subjects enrolled in this study will sign and informed consent and have 4 blood samples drawn     at different time points during their emergency department visit. In addition, data will be     collected about the patient's health history, hospital procedures, and final diagnosis. The     enrolling center will also contact the patients at 30-days, 3 months and 6 months to inquire     about their condition and survival.      Blood samples collected in this study will be sent to the sponsor organization for long-term     storage and analysis in the future for novel blood markers as they become available. No     genetic testing will be conducted on these samples.   "
250456|NCT01134926|"     The aim of the study is to find out whether conservative treatment - expectant management or     medical therapy using misoprostol is beneficial in the case of uterine residua, and which     treatment is better.   "
250457|NCT01134939|"     The question that prompted this study is the extent to which results from clinical trials can     be translated into everyday practice (external validity). First and foremost are questions     about tolerability and the efficacy of an antiretroviral combination treatment with Viramune     and other antiretroviral partners. In particular, adverse events will be recorded depending     on gender and the therapeutic effect will be monitored via the course of viral load and     improvement of the immune system, based on the CD4 cell count.   "
250458|NCT01134952|"     Different immunosuppressive drugs used in transplantation may reduce the body's defences     against infection differently. It is known that patients with Hepatitis C virus, known as     HCV, who switched from azathioprine to mycophenolate mofetil experienced an increase in viral     load. Despite this, mycophenolate mofetil is used because it prevents rejection more reliably     than azathioprine. Sirolimus is an another immunosuppressive agent that reliably prevents     rejection and may have antiviral activity. This study is designed to see if the viral load of     HCV and other viruses is reduced by switching from mycophenolate to sirolimus.   "
250486|NCT01135316|"     Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15     sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and     followed for up to 24 months.   "
250460|NCT01134978|"     The overall goal of this study is to gain insight into the neural mechanisms of learning     multiple tasks. By examination of cognitive and behavioral output during the performance and     learning of several computer maze tasks, and through a detailed examination of the neural     activity obtained from functional near-infrared (fNIR) and electroencephalography (EEG), it     may be possible to gain insight into the impact of the amount of practice and the     organization of practice has on learning fine motor skills. This insight may provide     direction as to how to better develop instructional and rehabilitation protocols in addition     to clinical interventions to facilitate recovery of function, relearning and transfer of     cognitive and fine motor skills based upon neural responses to physical practice.   "
250461|NCT01134991|"     Acne rosacea is a chronic acneiform disorder affecting both the skin and the eye. It is a     syndrome of undetermined etiology characterized by both vascular and papulopustular     components involving the face and occasionally the neck and upper trunk.      This is a pilot phase II study to evaluate the tolerability and safety and to monitor the     clinical efficacy of Topical Minocycline Foam FXFM244 in moderate to severe Rosacea patients.   "
250462|NCT01135004|"     Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. The     estimated recurrence rate is 23-50% after the first episode and increases to 60% after the     second pneumothorax. The pathogenesis of this benign disease remains unclear. Generally,     rupture of the emphysematous change or blebs in the apex of the lung is considered as the     cause of pneumothorax. The main purpose of this study is to investigate the molecular     pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy     patients.   "
250463|NCT01135017|"     Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF)     burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a     permanent pacemaker.      Secondary objectives were to evaluate:        -  the effects of dronedarone on AF pattern characteristics i.e. ventricular rate during          AF;        -  the effects of dronedarone on subject-perceived AF burden and symptom severity as          reported by subjects using the Atrial Fibrillation Severity Scale (AFSS);        -  the incidence of electrical cardioversion (or overdrive pacing) during treatment;        -  the safety of dronedarone.   "
250464|NCT01135030|"     The purpose of this study is to look at two different referencing systems for total knee     replacement surgery. In anterior referencing system, referencing cuts are made from the front     surface of the femur. This allows for a more exact cut. The anterior referencing system is     more difficult for the surgeon to use. This may increase surgery time. Posterior referencing,     on the other hand, references cuts from the back of the femur. The posterior referencing     system is quick and easy for the surgeon to use. Posterior referencing may lead to notching     of the femur. The risk of notching is very low and may not affect your results. This is a     study that has never been done before. Dr. Heekin uses both referencing systems in his     practice. He would like to determine which knee referencing system allows for greater knee     flexion after surgery. Knee flexion correlates with function and the ability to return to     everyday activities. For example, getting up from a chair, going up and down stairs,     stooping, and kneeling.   "
250465|NCT01135043|"     simple verbal intervention with figure of lung and upper respiratory tract will be helpful to     adequately collecting sputum.      and in the acceptable specimen based on Gram stain, positivity for AFB stain and culture rate     will be higher.   "
250466|NCT01135056|"     The primary objective of this study is to assess the efficacy of SIRT as compared with     Sorafenib in patients with locally advanced liver cancer in terms of overall survival (OS).      The Study null hypothesis is, there is no difference in overall survival between patients     receiving SIRT and those receiving Sorafenib therapy.   "
250467|NCT01135069|"     The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear     Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.   "
250468|NCT01135082|"     The purpose of this study is to evaluate the immunogenicity and safety of 7 - valent     pneumococcal conjugated vaccine in HIV - infected children, and assess the predictive factors     for protective antibody responses after receiving the vaccine.   "
250469|NCT01135095|"     A prospective single clinical trial to validate the use of a low-dose (~5mSv) Tc-99m protocol     with a high-efficiency cardiac dedicated camera (Dynamic Single Photon Emission Computed     Tomgraphy; D-SPECT) to detect myocardial perfusion abnormalities during myocardial perfusion     imaging.   "
250470|NCT01135108|"     The purpose of this study is to determine whether KAI-1678 is effective in the treatment of     pain associated with spinal cord injury.   "
250471|NCT01135121|"     The purpose of this study is to determine whether the diaphragm develops contractile fatigue     during a weaning trial and if this is associated with weaning failure.   "
250472|NCT01135134|"     This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate     (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of     age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days     at minimum and eligibility for inclusion in this study will be assessed. Following the     observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week     double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2     weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse     events (AEs), will be evaluated. A 30-day follow-up visit will take place after the     completion (or discontinuation) of the 2-week treatment period, to confirm presence or     absence of serious adverse events (SAEs) and trial procedure-related AEs.   "
250473|NCT01135147|"     The goal of this research is to study the prevalence of sleep disordered breathing and     associated morbidity in obese children and to examine the role of diet and physical activity     in the treatment of sleep-disordered breathing in obese children.   "
250504|NCT01135550|"     The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus     high dose dexamethasone in the treatment of radiation induced vomiting.   "
250505|NCT01135563|"     This study is a Phase I study using vinblastine and sirolimus in patients with relapsed solid     tumors including selected brain tumors and lymphoma. The investigators hypothesis is that the     combination administration of weekly vinblastine and sirolimus is safe.   "
250474|NCT01135160|"     The regime in the aftercare after total hip and knee arthroplasty(THA/TKA) differs a lot     between orthopedic surgeons concerning weight bearing. The type of implant and the way of     implants' anchoring are considered.      In the literature there is no data so far about the way patient take care of the recommended     weight bearing during the first 6 weeks after THA and TKA.      Over a one year period starting August 2010 all patients undergoing TKA or THA at the     investigators institution will have a technical device in their shoes (sole) to measure the     load in each step they do in these shoes during the first 6 weeks. Patients are asked to fill     out a standardised pain protocol every day (VAS) and document need of pain medication. The     investigators recommend 20kg of weight on the operated leg for 6 weeks and full weight     bearing at the end of week six.      The investigators believe that patients will adjust weight bearing to their level of pain and     not to their surgeons recommendations.   "
250475|NCT01135173|"     The study is a two-group parallel arm randomized clinical trial, to be conducted at the     Syrian Center for Tobacco Studies (SCTS) in Aleppo, Syria.   "
250476|NCT01135186|"     Kuvan® (sapropterin dihydrochloride) for Improving Gastric Accommodation in Women with     Diabetic Gastroparesis (KIGA-DG)   "
250477|NCT01135199|"     The purpose of this study is to determine the safety and efficacy of pomalidomide over a 12     week duration in the treatment of chronic cough in patients with IPF as measured by a Cough     Symptom Diary, Visual Analogue Scale for Cough Severity, Leicester Cough Questionnaire, St.     George Respiratory Questionnaire, Cough-Specific Quality-of-Life Questionnaire, and adverse     event reporting. There will be an option open to participants, who respond to treatment by     meeting pre-determined criteria, to remain in the study for an additional 9 months or for a     total of 54 weeks.   "
250478|NCT01135212|"     The purpose of this clinical study is to evaluate and compare the efficacy and safety of     Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate     hypertension.   "
250479|NCT01135225|"     The purpose of the EVOLVE Trial is to assess the safety and performance of the     everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of     up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety     and performance of two different drug release rate formulations of the Evolution Stent will     be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.   "
250480|NCT01135238|"     The adrenal glands are one of the most common organs involved in metastatic disease.     Metastases are the second most common type of adrenal mass, second only to adenomas. It is a     frequent finding during autopsy with a reported rate as high as 27% in patients with known     primary malignancy. Although several studies have found an increased survival in patients who     undergo resection of solitary adrenal metastases the indications for adrenalectomy in cases     of metastatic adrenal tumor remain controversial. Collinson et al reported an increased     survival in patients with melanoma. Median survival was 16 months for patients who underwent     adrenalectomy compared to 5 months for patients with documented adrenal metastases treated     non surgically.      The aim of this study is to compare retrospectively in case and control study, performing     adrenalectomy, open or laparoscopic, versus supportive treatment for patients with solitary     adrenal gland metastases. The investigators will review charts of patients between January     1994 and November 2009 who had adrenal gland metastases. The variables the inevstigators will     compare are mortality, morbidity, primary tumour sites, histological cell type, age, tumour     size, presence of synchronous metastases, mean time from diagnosis of primary tumor to     treatment of adrenal metastases, indication for adrenalectomy, partial versus total     adrenalectomy, suspected versus confirmed metastatic disease.   "
250481|NCT01135251|"     One hundred consenting AIDS patients suffering from treatment induced painful neuropathy will     be blindly randomize to Active and Placebo groups (ratio A/P = 3/2 and will receive     increasing oral doses of dimiracetam starting from 400 mg b.i.d. and doubling the dose every     two weeks until a maximum of 1600 mg b.i.d. Escalation to the the higher dose is allowed only     if the previous dose did not cause tolerability problems. The highest reached dose will be     maintained for a total of 8 week treatment. Patients must have a self evaluated pain of at     least 4 on a 10 cm visual analog scale (VAS). Primary end point of the study will be the     number of Adverse Events (AEs) reported in the placebo versus the active group. Preliminary     evidence of efficacy will be sought by comparing active and placebo group as to the intensity     of their pain at study onset and at study end. The pain will be evaluated by the VAS the     Total Symptoms Score and the Clinical Global Impression   "
250482|NCT01135264|"     In the proposed two-arm randomized controlled trial, 200 patients meeting DSM-IV criteria for     PG will be randomized to 12 sessions of Cognitive-Motivational Behavior Therapy (CMBT) or to     Cognitive Behavior Therapy (CBT).   "
250483|NCT01135277|"     Patients in the ICU are already predisposed to nosocomial infections, which are both costly     and potentially life threatening, and it appears that the immune paralysis of sepsis may put     these patients at greater risk for secondary infections, though this has not been proven     conclusively. One measure of this sepsis-induced immune suppression is monocyte deactivation.     The investigators hypothesize that, as a cornerstone of the monocytic innate immune response     to infection, the inflammasome is critical to monocyte function during sepsis.   "
250484|NCT01135290|"     This study tests two different approaches to the resolution of facial skin resurfacing.   "
250485|NCT01135303|"     The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in     adults is now well documented as well as its cardiovascular repercussions. Previous studies     showed a conclusive link between SAHS and severe cardiovascular diseases such as     hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health     issue in adults.      In this context, early detection of such a disease is crucial if the management is tailored     to the patient, the practitioner's choice of therapy moving towards continuous positive     airway pressure (CPAP) or mandibular advancement device. The detection is based on full     nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold     standard but it is a time consuming and costly examination. Polygraphic recording is a test     that allows simplified the diagnosis of severe patients, but may not be sufficient for mild     form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation     of a technique for identifying patients most at risk to either limit the number of     polysomnographic examination is requested.   "
250487|NCT01135329|"     This research is being done to learn more about reduced-intensity bone marrow transplantation     (BMT), also known as a mini transplant for patients with blood cancers, using bone marrow     from a relative.      The main goal of the study is to determine how quickly the donor's bone marrow takes in     your body. Other goals include describing how many people accept the bone marrow and how     quickly the blood counts come up; describing Graft-versus-host disease (GVHD) and other     complications; and describing how many people survive without progressive cancer and survive     overall   "
250488|NCT01135342|"     The goal is to determine if improved sleep will increase/enhance weight loss among overweight     adults with insomnia.   "
250489|NCT01135355|"     The aim of our study is to determine whether a clinically relevant laboratory measurement (of     seven specific immunologic biochemicals in the blood) can identify which bone marrow     transplant recipients are likely to progress to respiratory failure. Our ultimate goal is to     devise a comprehensive and inclusive laboratory test that is effective at determining who is     likely to go on to respiratory failure, in order to facilitate early medical intervention.   "
250490|NCT01135368|"     The purpose of this study is to measure the safety, efficacy and quality of life of     lansoprazole in patients with reflux disease over a five year period.   "
250491|NCT01135381|"     For complex medical patients, the transition from hospital to home-based care is a vulnerable     period, placing the patient at high risk for adverse events. Using a Care Transition     conceptual model, the investigators propose developing and evaluating, through a randomized     controlled trial, e-Coach, an Interactive-Voice-Response-supported (IVR) Care Transition     coaching intervention, focused initially on patients hospitalized with heart failure or     obstructive lung disease. This trial will test the primary hypothesis that the proportion of     patients with one or more re-hospitalizations during a 90-day post-discharge follow-up period     will be less in an IVRsupported care transition intervention (e-Coach) compared to a usual     care comparison group.   "
250492|NCT01135394|"     The purpose of this study is to determine predictors of response to pioglitazone, an     anti-diabetic medication. The investigators know from randomized clinical trials that some     30% of patients do not respond to this type of medication. There is presently no way to     identify this group of patients leading to unnecessary drug exposure and medication costs.   "
250493|NCT01135407|"     Parkinson's disease (PD), which is generally considered to be a motor disorder, is now known     to be accompanied in many instances by a variety of cognitive defects. This can be explained     considering that PD is a neurodegenerative and progressive disorder of the basal ganglia     system, which works modulating not only motor, but also cognitive and emotional behaviours.      Concerning this, some studies suggest that non-demented PD patients may suffer from a     voluntary selective visual attention orienting deficit, showing a reduced skill in focusing     upon one target, and may be easily distracted from irrelevant but salient stimuli, with a     consequent negative impact on their physical health, social interactions and quality of life.      Up to now, the evidence of the role of the basal-ganglia system in modulating visual     attention functions is poor and indirect and the effects of dopaminergic and subthalamic     nucleus (STN) stimulation (two usual and effective treatments in PD) on attention     performances are controversial.      The main objectives of the project are: 1) to assess the visual selective attention as well     as the distractibility in PD patients; 2) to study the effects of patient's usual     antiparkinsonian treatments, that is dopaminergic and STN stimulation, on visual attention     performances.      Secondly, from a clinical and neurophysiologic point of view, the investigators want to study     the respective role of the dopaminergic pathways and the sensorimotor and associative/limbic     cortico-basal ganglia loops passing across the STN in the visual attention performances.      To precisely answer the objectives of the protocol, the investigators will record the     performances of participants during the administration of 3 computerized tests, which are     suitable to study visual attention, decision making and motor performances.      The investigators will compare the performances on the computerized tests of two groups of PD     patients, one evaluated in different sets of electrical (without stimulation, or selective     stimulation of the sensorimotor or associative/limbic part of the STN) stimulation, the other     in different conditions of medication (with or without dopaminergic treatment) with those of     a group of healthy subjects.   "
250494|NCT01135420|"     This research program will improve the care and treatment outcomes of dually diagnosed     veterans who receive inpatient psychiatry care, and decrease their use of VA inpatient mental     health services. It will increase the use of substance abuse outpatient care and 12-step     groups to benefit recovery, reduce rehospitalizations, and reduce costs for VA.   "
250495|NCT01135433|"     This study is to evaluate the efficacy and safety after concomitant administration of ASP1941     and metformin in patients with diabetes mellitus.   "
250496|NCT01135446|"     The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK),     safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in     healthy subjects.   "
250497|NCT01135459|"     The primary objective of this study is to evaluate the efficacy of a 200-mcg dose of     CEP-33457 compared with placebo in patients with active systemic lupus erythematosus (SLE) as     assessed by the proportion of patients achieving a combined clinical response using the SLE     responder index (SRI) at week 24.   "
250498|NCT01135472|"     This dose response study is proposed to explore the extent to which Nexium increases     endogenous gastrin concentrations and to assess whether Nexium treatment may be useful in the     setting of islet cell transplantation for type 1 diabetes to expand islet cells in vivo after     transplant.   "
250499|NCT01135485|"     The purpose of this study is to determine whether children and adolescents 8-18 years of age     with HLHS and related lesions who have undergone stage I palliation during infancy using an     allograft patch demonstrate continued evidence of HLA antibody formation.   "
250500|NCT01135498|"     This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox     (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal     cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day     1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1).     Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every     3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until     disease progression, and the target sample size is <100 individuals.   "
250501|NCT01135511|"     The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye     drops in patients with dry eye disease.   "
250502|NCT01135524|"     The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS.     Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a     maximum of BTDS 20 to achieve stable pain control.   "
250503|NCT01135537|"     This study will describe the pharmacokinetic disposition of biologically active rabbit     anti-thymocyte globulin (rATG) after a consistent dose of 7.5 mg/kg/course given as part of     the conditioning regimen in children undergoing hematopoeitic stem cell transplantation     (HSCT).   "
250506|NCT01135576|"     -  The objective of the study is to know if consumption of an iron fortified fruit juice          containing micronized iron pyrophosphate, is useful to increase iron status in women          predisposed to iron deficiency anemia.        -  A secondary objective is to know if consumption of this iron fortified fruit juice          modifies bone remodelling.   "
250507|NCT01135589|"     This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic     stem cell transplantation. Micafungin is administered until confirmation of neutrophil     engraftment or treatment failure.   "
250508|NCT01135602|"     12-week, open-label study of topiramate in hospitalized patients with alcoholism   "
250509|NCT01135615|"     Vascular calcification and endothelial dysfunction (ED) contribute to the development of     cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a     non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification     in CKD patients while the exact mechanism has not been clarified.      This study was designed to investigate the effect of short-term sevelamer treatment on both     serum FGF23 levels concentrations and ED seen in CKD patients.      The researchers investigated the relationship between plasma FGF23 levels and the forearm     blood flow response to ischemia in the forearm in a sizable series of incident stage 3-4 CKD     patients.   "
250510|NCT01135628|"     Hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden     of diseases with therapeutical difficulties for its given morbidity and mortality and the     high recurrence it poses. Its treatment remains a challenge for most of the cases. Even more,     minimal hepatic encephalopathy is an entity that has an additional morbidity for it being a     subclinical entity. As so, the investigators propose an auxiliary treatment for the     management of such patients with minimal hepatic encephalopathy, using a specific diet     consisting on hyperproteic and fibre-rich foods along with two independent interventions,     whether a probiotic, lactobacillus reuteri, or a drug, nitozoxanide, so to diminish the rate     of progression to any clinical stage of hepatic encephalopathy and to revert minimal hepatic     encephalopathy itself to none hepatic encephalopathy.   "
250511|NCT01135641|"     The main objective of the study is to improve the response rate (complete and partial     remission) at 12 months after diagnosis of chronic Chronic Graft Versus Host Disease (GVHD)     and treatment with the combination of ciclosporine, prednisone and Rituximab as first line     treatment.   "
250512|NCT01135654|"     The purpose of this study is to determine whether Alcohol Screening, Brief Intervention, and     Referral to Specialty Chemical Dependency Treatment (as appropriate) by Non-Physicians versus     Primary Care Providers (versus control group) is more likely to be implemented and more     effective at reducing unsafe drinking.   "
250513|NCT01135667|"     All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for     clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before.      A cut off value has previously been established. Only low-responders with Multiplate values     above the cut off value are included in the study. The patients are randomized to either     clopidogrel 150 mg once daily or Prasugrel 10 mg (age > 75 og bodyweight < 60 kg 5 mg)once     daily for 30 days after the procedure.      Follow up will be at 30 days after PCI were another MULTIPLATE test will be performed.      Primary endpoint:Platelet inhibition (by MULTIPLATE) after 30 days of intensified     antiplatelet therapy.      Clinical endpoints such as bleeding complications (GUSTO, TIMI) during treatment, and major     adverse cardiac events (MACE) at 30 days will be collected and reported but the study size     does not allow for formal statistical analysis The study ends by the 30 days follow up visit     and all patients continue with clopidogrel 75 mg once daily for another 11 months (not study     related)   "
250514|NCT01135680|"     Arm 1:      Primary Objective:      • To determine the safety and tolerability of multiple ascending, supratherapeutic doses of     HPN-100.      Arm 2:      Primary Objective:      • To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid     [PBA], phenylacetic acid [PAA], and phenylacetylglutamine [PAGN]) on 12-lead     electrocardiogram (ECG) parameters in healthy male and female subjects with the primary     endpoint being the time-matched change from baseline in the QT interval corrected for heart     rate (HR) based on an individual correction method (QTcI).   "
250515|NCT01135693|"     Section 136 of the Mental Health Act (MHA) 1983 allows the police to detain someone in a     public place if there are reasons to believe that they may be suffering from a mental     disorder and to be in need of care or control. For a significant number of psychiatric     patients, detention under section 136 and accessing psychiatric services via the police     remains an important, and sometimes the only pathway to care. Approximately 17400 people were     detained under section 136 of the MHA 1983 during the year 2005-2006 (Independent Police     Complaints Commission, 2008).      Despite the large number of patients accessing mental health services via the police, there     is no research available to identify the service users' perspective of what led them to come     into contact with police and to identify the reasons for care not being accessed by     conventional routes. Royal College Psychiatrists (RCP, 2008) and Independent Police     Complaints Commission (IPCC, 2008) found that there was lack of research into the service     users' perspective and recommended research into this area.      The investigators have devised this research project to help themselves and the wider     research and clinical community understand the service users' perspective of how they came to     be detained by the police, whether the community services had failed and explore their views     to understand what can be done to improve the service provisions.      Fieldhead hospital, Wakefield provides acute inpatient care for psychiatric patients. Those     who are detained under section 136 of the MHA in Wakefield area are taken to a place of     safety and following assessment they may be admitted formally or informally to Fieldhead     hospital for assessment and treatment. Those who are detained under section 136 of MHA and     subsequently admitted as inpatients to Fieldhead hospital will be included in this study.   "
250516|NCT01135706|"     The investigators propose to confirm that normotensive and hypertensive pulmonary arteries     are fractal, as well as define if the FD correlates to disease severity when compared to     available data such as six-minute walk and right heart catheterization measurements.   "
250517|NCT01135719|"     Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye     with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized     excimer laser.   "
250518|NCT01135732|"     PROTOCOL      Introduction: The introduction of endoscopic retrograde cholangio-pancreatography (ERCP) and     endoscopic sphincterotomy (ES) in 1974 has dramatically changed the treatment of biliary and     pancreatic diseases. ES permits transection of Oddi's sphincter, allowing the endoscopist to     remove stones and place stents.      The main indications for ERCP are: 1. Removal of common bile duct stones 2. Dilation of     benign biliary ducts strictures 3. Stent placement in patients with malignancy 4. Acute     biliary pancreatitis 5. Removal of stones and dilation of strictures of the main pancreatic     duct in patients with chronic pancreatitis and 6. Treatment of biliary fistulae after     surgical operations .      Complications of ES can be described as early (within one month after ES) and late. Early     complications have approximately a 10% incidence and include: 1.acute pancreatitis (5,4%)     2.bleeding (2%) 3.acute cholangitis (1%) 4.acute cholecystitis (0,5%) 5. Perforation and     others (1,1%). Late complications are mainly the recurrence of choledocholithiasis (2,5%),     narrowing of the previous ES and recurrent acute cholangitis. Furthermore, there is a debate     in the literature about late development of cholangiocarcinoma.      Carcinogenesis after surgical sphincteroplasty and biliary-enteric anastomosis has been     described. Previous studies have shown late development of cholangiocarcinoma after     transduodenal sphincteroplasty and biliary-enteric anastomosis for benign disease. The     incidence is up to 7% in a twenty-year follow up, while in the general population is     approximately 1/ 100.000 . In addition, Tocchi et al showed that the rate of     cholangiocarcinoma after transduodenal sphincteroplasty and choledochoduodenal anastomosis is     up to 5-7% and after other choledochi-enteric anastomoses approximately 1,9%. It seems that     the ablation of sphincter function causes prolonged pancreatobiliary and duodenobiliary     reflux. Proteolytic pancreatic enzymes are activated and bacterial intestinal flora colonizes     the biliary epithelium, causing recurrent inflammation. Chronic inflammatory irritation may     lead to hyperplasia, dysplasia and atypia of epithelium, ultimately inducing carcinogenesis.      Eleftheriadis et al, studied changes of the biliary epithelium in patients who underwent     choledochi-duodenal anastomosis for benign disease, and hyperplasia of the biliary epithelium     was demonstrated. The same results and atypia of biliary epithelium were reported by Kurumado     et al, in mice models with choledochi-duodenal anastomosis. Anomalous pancreatobiliary     junction and choledochal cysts produce the same histologic alterations of the biliary     epithelium.      These facts raise a great amount of concern about late development of cancer after ES.     Bergman et al in a small trial argues that after ES, the function of the biliary sphincter is     permanently lost. On the other hand, Sugiyama et al demonstrated the reduction of     pancreatobiliary reflux 1 year after ES. In addition, large population-based studies have     shown no causal association between ES and cholangiocarcinoma, but with enough limitations in     study design. In conclusion, the long term cytologic changes of the biliary epithelium after     ES for benign disease are not well known.      During ERCP, brush cytology can be performed to evaluate bile duct strictures. The use of     endoscopic brushing after ES has no reported complications .      Objective: To evaluate cytologic alterations of the biliary epithelium after previous     endoscopic sphincterotomy for benign disease.   "
250519|NCT01135745|"     The purpose of the study is to monitor the safety and performance of Reclaim® Deep Brain     Stimulation (DBS) Therapy in patients with chronic, severe, treatment-resistant Obsessive     Compulsive Disorder.   "
250546|NCT01136096|"     Investigators hypothesized home-based exercise intervention was beneficial to those who have     had diabetic risk factor for type 2 diabetes mellitus   "
250752|NCT01138306|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in samples from young patients with acute     myeloid leukemia.   "
250520|NCT01135758|"     Targeting the glutamatergic system to treat depression is a new and promising strategy based     on studies at the molecular, synaptic, and neuronal level but also on results of studies     conducted in animal models and first clinical studies involving depressed patients.Ketamine     has been proposed as a novel approach to induce rapid antidepressant response. In this pilot     project the investigators aim to introduce this novel and promising approach into clinical     practice. Besides the assessment of clinical efficacy, the investigators will put a special     emphasis on the assessment of ketamine-associated effects on brain function using fMRI and     cognitive testing.   "
250521|NCT01135771|"     This study is designed to demonstrate the accuracy of the OptiScanner glucose measurement.     The accuracy of the test device will be determined using plasma samples collected directly     from Type 1 and Type 2 Diabetics using the OptiScanner. Blood samples will simultaneously be     collected and measured on YSI 2300 STAT PLUS (YSI) made by YSI Incorporated. These results     will be compared to the OptiScanner's glucose measurement.   "
250522|NCT01135784|"     The purpose of this study is to study MIGRA-ZEN RELIEF PLUS, an all-natural herbal dietary     supplement product, with respect to alleviating and/or stopping migraine headache pain     compared to a placebo when used prophylactically. This study will involve subjects suffering     from chronic migraine headaches.   "
250523|NCT01135797|"     The objective of this study is to collect retrospectively long term safety data in patients     who have participated in the previous phase I-II trials conducted with the compound.   "
250524|NCT01135810|"     Hypnotic trance and mindfulness meditation have both been shown to have benefits for physical     health. The current study seeks to determine if there are distinct patterns of brain activity     that correlate with hypnotic trance, mindfulness meditation or both, and to relate these     patterns to measurable markers of physical well-being. Precise neuroimaging of heightened     attentional states will guide future researchers and practitioners toward more effective     techniques of mind/body control.   "
250525|NCT01135823|"     The primary purpose of the proposed research is to explore methods of obtaining symptom     assessments from pediatric oncology patients and/or their caregivers in hopes of improving     the accuracy and thoroughness of these reports. Additionally the researchers hope to simply     staff efforts in obtaining detailed medical histories from pediatric oncology patients.   "
250526|NCT01135836|"     Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter     hospitalizations, and less post-operative pain as compared with traditional laparotomies.     However, there is marked interindividual variability of post-operative shoulder-tip pain     following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and     ranges from mild to severe. In some cases, it has been reported to last more than 72 hours     after surgery.      The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic     nerve irritation causes referred pain to C4. Therefore, the investigators should try to     reduce carbon dioxide retention in the pelvic cavity.   "
250527|NCT01135849|"     We hope to determine the importance of different genes (including B receptors) in     anthracycline-induced cardiomyopathy. This has important benefits to patients exposed to     anthracyclines, as this could help determine whether certain individuals have increased     susceptibility to cardiac injury.   "
250528|NCT01135862|"     Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality.     Although not fully proved, it is commonly accepted that the morbidity and mortality and     proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more     injury than smaller ones).      Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The     antiaggregate effect may be neutralized by administration of platelets. Thus, potentially,     patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an     intracranial bleed.      In this prospective study, the investigators randomize patients receiving aspirin that have a     traumatic intracranial bleed to two groups, one - that will receive platelets, and the other     that will not receive platelets.      The primary end point of the study is to evaluate the effect of platelet administration of     the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome     differences between the two groups.   "
250529|NCT01135875|"     The purpose of this study is to determine if tumor cells can be detected in the blood of     patients diagnosed with a brain tumor.   "
250530|NCT01135888|"     Because of their lack of sweat glands individuals with hypohidrotic ectodermal dysplasia     (HED) are at particular risk of life-threatening hyperthermia during exercise in a warm     environment. In this study, the effects of physical exercise are investigated in boys and     male adolescents with X-chromosomally inherited HED as well as age-matched controls, who     undergo standardized exertion on a bicycle ergometer at ambient temperatures of 25°C and     30°C. Body core temperature during and after ergometry, heart rate, performance, and serum     lactate as a marker of metabolic stress are measured. Subjects with HED are expected to show     an endangering rise of body temperature in connection with physical exercise. To clarify,     whether novel cooling devices may reduce the likelihood of overheating, the effects of such     devices are evaluated at 30°C.   "
250531|NCT01135901|"     This is a development project involving four different municipalities in Central Norway. The     aim is to identify adults with overweight and with an increased risk of developing diabetes     mellitus type 2, then to prevent the disease to develop by the means of a behaviour change     programme. The programme is group based.   "
250532|NCT01135914|"     To evaluate, specifically within the Canadian medical environment, the efficacy, safety and     cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus     laser photocoagulation), or as monotherapy in comparison with the current standard of care     (laser photocoagulation monotherapy), in patients with visual impairment due to DME.   "
250533|NCT01135927|"     This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect     of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.   "
250534|NCT01135940|"     This is a prospective, Phase II (hypothesis generating) randomized pilot study investigating     the efficacy of using Dermabond as a method of final wound closure as compared to the     standard staple method in children with Neuromuscular Scoliosis undergoing spinal deformity     correction surgery.   "
250599|NCT01129856|"     The purpose of this study is to assess the safety and efficacy of EGP-437 (dexamethasone     phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis system in     patients with dry eye.   "
250535|NCT01135953|"     tDCS has been shown to be an effective treatment for depression. However, tDCS is a     relatively new clinical tool and more needs to be understood about its use. This study hopes     to further the field of knowledge by examining how tDCS should be optimally used. Application     of tDCS in clinical trials of depression is typically to the prefrontal cortex, but in this     project, tDCS application will be to the motor cortex as it provides a more ready measure of     excitability. Excitability will be measured using Transcranial Magnetic Stimulation (TMS) to     the motor cortex and electromyography (EMG) recordings from peripheral muscles stimulated.     Using a cross-over three-arm design this study aims to investigate whether daily tDCS     administered in increasing intensity across sessions leads to greater and lasting effects on     brain excitability than keeping the intensity at a same dose across the days and whether the     excitatory effect could be enhanced with D-cycloserine, a medication known to prolong the     excitatory effects of a single session of tDCS. This in turn will inform on how to optimize     tDCS for therapeutic applications, e.g treatment of depression. The study hypothesis is that     5 sessions of tDCS with a dose of D-cycloserine given on the Monday and Thursday sessions     will result in more sustained effect on motor cortex excitability than 5 sessions of tDCS     alone. The second hypothesis is that the gradational increases in tDCS intensity over 5     sessions will result in greater motor cortex excitability than 5 sessions of tDCS where     intensity is kept constant across sessions.   "
250536|NCT01135966|"     Pulmonary rehabilitation has been emerged as a recommended standard of care for patients with     chronic lung disease based on a growing body of scientific evidence. A set of evidence-based     guidelines were published in American College of Chest Physicians (ACCP) and the American     Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). Since then, the     published literature in pulmonary rehabilitation has increased substantially, and other     societies have published important statements about pulmonary rehabilitation (eg, the     American Thoracic Society and the European Respiratory Society).      In patients with COPD, there is a strong scientific basis for implementing conventional     resistance training (CRT) in addition to endurance training. Endurance training, such as     walking, is a key component of pulmonary rehabilitation and improves in exercise tolerance     and muscular endurance. However, this type of training may not reverse muscle weakness or     atrophy. For that reason, strength training seems to be the optimum training modality to     increase muscle mass and strength.      Recently, Whole-Body-Vibration (WBV) training has been promoted as an alternative for     resistance training on multigym equipment. In WBV training, the subject stands on a platform     that generates vertical sinusoidal vibration, during which static and dynamic exercises can     be performed.      The present study is conducted to provide an answer on the following question: will a     resistance training program, such as the whole body vibration, be even effective than a     conventional resistance training program in patients with COPD.   "
250537|NCT01135979|"     The purpose of this study is to investigate what effect a local anesthetic nerve block of the     arm in patients with end stage renal failure has upon blood flow in the skin of the arm.   "
250538|NCT01135992|"     This trial is conducted in the United States of America (USA). The aim of this clinical trial     is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec     (IDeg) in subjects with type 2 diabetes mellitus.   "
250539|NCT01136005|"     Objective:      To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific ≥ grade     2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and     the adherence during the 6-week skin treatment period. The adherence to the study creams will     also be studied.   "
250540|NCT01136018|"     Caudal epidural block is useful not only for regional anesthesia of low abdominal, perineal     area or lower extremities but for relieving acute or chronic pain of low back and lower     extremities. Recently, there were some reports that there was a difference of the contrast     flow pattern during lumbar epidural block according to a location of needle tip in the lumbar     epidural space. Therefore, the investigators hypothesize that there is a difference of     contrast flow pattern in caudal epidurography when a needle is inserted with intentionally     lateral direction.   "
250541|NCT01136031|"     -  Usually the combination of fluoropyrimidine with platinum is used as a first line          chemotherapy (for example, 5-FU+cisplatin, capecitabine+cisplatin, S-1+ cisplatin,          5-FU+oxaliplatin) in advanced gastric cancer.        -  After failure with this combination, taxane-based regimen or irinotecan-based regimen is          usually used. But, as a second-line regimen, the combination of topoisomerase inhibitor          with taxane has not been fully evaluated until now.        -  So we designed this phase I/II study to evaluate the efficacy and toxicity of          second-line chemotherapy with paclitaxel and irinotecan in fluoropyrimidine and          platinum-pretreated advanced gastric cancer.   "
250542|NCT01136044|"     The purpose of this study is to evaluate the possible harvest of a tensor fasciae latae flap     based on septocutaneous perforators.This study should further confirm our data from an     anatomical study concerning location, distribution, diameter and differentiation of the     perforators.   "
250543|NCT01136057|"     Treatment options are limited for the treatment of influenza. This study will collect blood     from people who have been exposed to the influenza virus or who have received a seasonal     influenza vaccine. The blood plasma will be used in a future clinical trial to treat people     hospitalized with influenza.   "
250544|NCT01136070|"     The present study seeks to examine the course of body image, social avoidance and     psychosocial aspects of depression and anxiety over time in burn patients. Gaining a better     understanding of the effects of burn injury on body image in burn patients over time could     help us to better understand the psychosocial sequelae of burns and to identify potential     interventions which may serve to improve the quality of life in burn patients.   "
250545|NCT01136083|"     Cancer is one of the leading health issues in this country and worldwide. Angiogenesis is an     essential process for tumoral growth and metastasis. This process is dependent on the balance     between angiogenic factors and antiangiogenic factors. Muscle wasting has been associated     with myostatin overexpression in cancer. Exercise training can depress tumor growth and     suppress myostatin expression, and enhance skeletal muscle angiogenesis in healthy people and     some animal studies. The purpose of this study is mainly to investigate the effects of     exercise training on        1. circulating VEGF-A        2. muscle growth and function        3. Myostatin   "
250547|NCT01136109|"     Previous research has shown that the Inferior Vena Cava Collapsibility Index (IVCCI) can be     used to assess volume status. One limitation of the previous work is that changes in     intra-thoracic pressure can influence this measurement, and the magnitude of this effect has     never been described. The investigators aim is to correlate the degree of change in IVCCI     with the set degree of change in intra-thoracic pressure in a heterogeneous population of     critically ill patients.   "
250548|NCT01136122|"     The purpose of this study is to see if treatment of OSA with the CPAP device makes a     difference to insulin resistance and heart disease.   "
250549|NCT01136135|"     To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial     biopsies for serial detection (EMB) and follow-up of cellular rejection in heart transplant     in childhood.   "
250550|NCT01136148|"     This research is an evaluation of the MMHU compared to standard care. Patients who are over     65 and 'confused' at admission will be randomly allocated to the MMHU or standard care. The     MMHU does not have capacity for all confused older patients admitted to NUH, and random     allocation is similar to what happens in practice currently. For this study, 480 of these     patients will be recruited, together with a carer (240 from the MMHU, 240 from standard care     wards). The investigators will collect baseline information about the patient participant's     physical and mental health and disability.      The investigators will count the total days spent at home and measure patient participants'     health status after 3 months, and use of resources over six months. Carer strain and quality     of life will be measured at baseline and follow up.   "
250551|NCT01136161|"     The aim of the trial is to assess the safety, tolerability and immunogenicity of two doses of     RUTI® vaccine administered four weeks apart after one month pre-treatment with INH.      The trial will be double-blinded, randomized and placebo-controlled with 96 subjects (48 HIV-     and 48 HIV+ subjects).      Three different RUTI® doses and placebo will be tested, randomizing assigned both in HIV+ and     HIV- subjects. Each subject will be randomized to receive one of the four treatments     (placebo, 5, 25, 50 μg), after completion of one month INH pre-treatment (one tablet of     300mg/day, vp.o.). Each subject will receive two administrations of the same treatment, 28     days apart. Subjects will be monitored until one month after the second inoculation with     RUTI®.   "
250552|NCT01136174|"     To investigate safety of BIBF 1120 in Japanese patients with idiopathic pulmonary fibrosis     (IPF), with and without pirfenidone background treatment.      To assess pharmacokinetics of BIBF 1120 in Japanese patients, with and without pirfenidone     background treatment.      To assess pharmacokinetics of pirfenidone in Japanese patients, alone and in combination with     BIBF 1120 treatment.   "
250553|NCT01136187|"     Percutaneous coronary interventions (PCIs) from the femoral approach have more bleeding     complications related to access site in comparison to the radial approach in patients with     acute coronary syndrome (ACS). Major bleeding and access site complications have an important     role in results of PCI for ACS and lead to higher morbidity and mortality. Primary PCIs in ST     elevation myocardial infarction (STEMI) are associated with more aggressive antithrombotic     treatment than in elective or semi-urgent interventions. Currently, both radial and femoral     approaches are routinely used for primary PCI in STEMI. However, only non-randomized studies     and registries or small randomized single center studies comparing both approaches in primary     PCI have been published until now. The aim of STEMI-RADIAL trial is to evaluate potential     reduction of bleeding complications in the radial approach primary PCI compared to femoral     approach in randomized, multicenter study.   "
250554|NCT01136200|"     CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions     ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve     the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet     fully estimated using a randomized trial to compare the quality of care of patients who will     benefit of the intervention.      OBJECTIVES: To show using a randomized trial that patients with IDS advice will receive more     appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients     who will not receive IDS advice.      METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of     prescriptions in two groups of patients:        -  Control group: antibiotic prescriptions will be initiated and managed by the attending          physicians        -  Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS          and changed if judged necessary by the attending physicians, following IDS' advice.      STUDY PROCESS: The study will took place in 4 university hospitals. Two medical or surgical     wards will participate by hospital. For each ward, the period of the study will be 2 x 4     weeks.Total duration of the study: 12 months.   "
250555|NCT01136213|"     Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder of the adult     associated to a poor prognosis. MSA is clinically characterized by the association of     extra-pyramidal, dysautonomic, cerebellar and pyramidal symptoms. Histological and biological     studies have raised the hypothesis that, beside the well known dopamine deficiency, some of     the symptoms could be related to a dysfunction in serotoninergic neurotransmission. Serotonin     is involved in the modulation of several functions impaired in MSA, such as mood, motricity     or sleep. The recent description of an association between loss of brainstem serotonin     neurons and sudden death in patients with MSA reinforced the hypothesis of a critical role     played by this neurotransmitter in the pathophysiology of this disease. Autoreceptors called     5-HT1a are strongly involved in the regulation of serotonin neurotransmission. During the     last years several radio-ligands allowing in vivo PET quantification of 5-HT1a receptors,     such as 18F-MPPF     (4-(2'-methoxyphenyl)-1-[2'-(N-2''-piridinyl)-p-fluorobenzamide]methylpiperazine), were     developed. Moreover, the investigators recently demonstrated the ability of this brain     functional imaging method to investigate, in healthy volunteers, the functional properties of     5-HT1a autoreceptors through an evaluation of their desensitization after a single oral dose     of fluoxetine.   "
250556|NCT01136226|"     The purpose of this study is to determine if testosterone will recover to 90% by year 1 after     using Eligard.   "
250557|NCT01136239|"     This study is to investigate the add-on effect of high dose NAC (600mg tablet twice daily) on     reduction of airtrapping and airway resistance in stable COPD patients as well as to study     it's effect in reducing exacerbation, improving exercise capacity and quality of life in     stable COPD patients.   "
250558|NCT01136252|"     Adalimumab is a humanized recombinant monoclonal antibody fragment targeted against tumor     necrosis factor. This study will assess the safety and efficacy of intravitreal adalimumab     administered in patients with choroidal neovascularization secondary to age-related macular     degeneration non-responders to the conventional treatment with intravitreal ranibizumab.   "
250559|NCT01136265|"     In this study, the investigators want to pre-operatively scan patients who do not have any     clinically suspicion of metastases with an 18F-FDG-PET/CT whole body scan , where after they     go to lymphoscintigraphy incl. SPECT/CT and sentinel node biopsy. Material from the oral     cancer and, after permission of each patient, also normal oral tissue will be analyzed     molecular-biologically. Also a blood sample will be analyzed for molecular tumor markers.      The investigators want to see if PET/CT is able to detect any signs of sub-clinically     metastases. Besides, the investigators want to fusion PET/CT with SPECT/CT data from the     lymphoscintigraphy study and improve our PET/CT scanning with a dual-time PET scan of the     head-and-neck region.   "
250560|NCT01136278|"     The purpose of this study is to determinate the effect of a pre-treatment with centrally     acting alpha2-receptor agonist clonidine on the pharmacodynamics and pharmacokinetics of     3,4-methylenedioxymethamphetamine (MDMA, Ecstasy). The investigators hypothesize that     clonidine will attenuate the subjective and cardiovascular response to MDMA.   "
250561|NCT01136291|"     Objective: To evaluate the association between physical exercise for obese or overweight     women and the maternal, perinatal outcomes and perception of these women about their quality     of life.      Methods: A randomized controlled clinical trial with 78 pregnant women. Overweight or obese     (BMI ≥ 26 kg / m²), gestational age between 14 and 24 weeks and from age 18 years were     included. They will be divided into two random groups: one which will an exercise program     under supervision and guidance received from home exercises (study group) and another that     followed the standard routine prenatal care service (control group). Both groups will receive     standardized nutritional counseling by the department of nutrition and dietetics and a     questionnaire measuring quality of life WHOQOL-short at 14 - 24 weeks and at 36 weeks of     pregnancy. The intervention results will be analyzed by intention to treat. A P value less     than 0.05 will be used to determine statistical significance.   "
250562|NCT01136304|"     With the participation of an international consortium of investigators, the investigators     will evaluate the validity of a new severity score system called DS3 for adult patients with     Gaucher disease. The investigators hypothesize that initial DS3 scores will be predictive of     both disease progression and patterns of response including imiglucerase dose sensitivity and     completeness and maintenance of response and that sequential DS3 scores will accurately     portray either clinical progression of disease or improvement in response to treatment. The     investigators will also collect DNA specimens that in future research will be used in     conjunction with the DS3 scores to evaluate determinants of the clinical course and the     response to treatments for Gaucher disease.   "
250563|NCT01136317|"     This study aims to determine, in obese subjects, the antisecretory effect of a single dose of     placebo, rabeprazole 20 mg and omeprazole 20 mg using 24h gastric pH monitoring, in a     prospective, monocentre, randomized manner. Monitorings are separated between 6 and10 days.     The main outcome criteria of analysis is the percentage of time with gastric pH above 3     during 24hours.   "
250564|NCT01136330|"     Myotonic dystrophy type 1 (DM1) is the most frequent neuromuscular disease in adults. DM1     patients have an impaired prognosis (mean age of death <60 years) due to cardiac and     respiratory complications.      Our primary objective was to identify cardiac and respiratory prognostic factors in DM1.   "
250565|NCT01136343|"     In Taiwan, heart disease and cerebrovascular disease ranked the second and third of ten     leading causes of death in female in 2007; half of these deaths is due to coronary artery     disease (CAD). Postmenopausal status is an independent risk factor for CAD. Early assessment     and proper management of risk factors may reduce the prevalence rate of CAD. In the past     decade, despite increased attention to CAD in women, most studies focused on certain     menopausal status instead of all phases of menopause or on risk factors limited to related     metabolic syndrome. Because the prevalence of risk factors related to CAD is influenced by     various physiological and lifestyle status in different menopausal statuses, the purpose of     this study, at the first stage, is to explore respectively the risk factors of CAD among     middle-aged women in three menopausal statuses. At the second stage, the influence of a     lifestyle management program on risk factors modification among pre-menopausal women is     examined in this study.   "
250566|NCT01136356|"     Buprenorphine is an approved medication for the treatment of opioid dependence. It is     typically administered once daily as a sublingual tablet combined with naloxone (i.e.,     Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical     dependence. In addition, some research suggests there is relatively little withdrawal     following cessation of chronically administered buprenorphine. This study will examine the     spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine     in opioid dependent individuals. This study will assess the characteristics and time course     of withdrawal using subject-rated and observer-rated measures of opioid withdrawal.     Physiologic measures and psychomotor performance will be collected during chronic opioid     administration and during placebo administration (i.e., during spontaneous withdrawal).     Particular attention will be paid to the differences (if any) in sleep disturbances and     withdrawal associated hyperalgesia.   "
250567|NCT01136369|"     The study will determine the sensitivity, specificity, negative predictive value and positive     predictive value of the OSNA Breast Cancer System by comparing its performance to permanent     section Hematoxylin and Eosin (H&E) and IHC staining.   "
250568|NCT01136382|"     This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6     weeks is effective and safe in treating asthmatic children aged 6 to <12 years   "
250611|NCT01130012|"     Gestational diabetes mellitus (GDM)is a major health problem        -  growing prevalence of obesity        -  the older age of pregnant women      A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.        -  feasibility of an early intervention        -  glucose tolerance at weeks 26-28   "
250612|NCT01130025|"     The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the     recurrence of VTE in patients with active cancer who have had an acute VTE episode.   "
250569|NCT01136395|"     This project comprises immunological and virological analyses within a prospective clinical     study of Rituximab (Rtx)-treated blood group incompatible living donor (LD) renal transplant     recipients compared to blood group compatible LD recipients without Rtx induction, and of     living donor compared to deceased donor renal transplant recipients treated with tacrolimus     (Tacr)/mycophenolate sodium (MPS). Aim of this project is to assess short- and long-term     effects of immunosuppressive therapy (Rtx induction) and of living donation on immunological     and histological parameters of graft outcome and on viral replication (BK, JC, CMV, EBV) with     the potential to improve long-term graft outcome and to enable risk estimation of virus     disease.   "
250570|NCT01136408|"     The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048)     administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with     non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with     warfarin.   "
250571|NCT01136421|"     Treatment with short acting β2 agonists for exacerbations of COPD results in clinical     improvement. It has not been established whether combining short acting β2 agonists to other     bronchodilators is more effective than β2 agonists alone. The aim of this study is to     evaluate the efficacy and safety of combination of SABA and MgSO4 in comparison to SABA and     ipratropium bromide (IB) in patients attending the emergency department for AECOPD.   "
250573|NCT01136460|"     Primary congenital glaucoma patients and their immediate relatives will undergo complete     ophthalmic examination and an interview with a geneticist. A blood sample will be drown from     all participants for DNA analysis.      The CYP1B1 gene coding sequences will be screened for all individuals. If no mutation or only     one heterozygous mutation will be found in the CYP1B1 gene, screening for MYOC gene mutations     will be performed.   "
250574|NCT01136473|"     In cell cultures, lens epithelial cells and trabecular meshwork cells will be exposed to     aqueous humor from pediatric eyes undergoing cataract removal surgery. Cytokine analysis of     candidate factors will be performed before and after exposure to lens epithelial.   "
250575|NCT01136486|"     The observation through a chart review of persistent pain on neuro psychological functioning     and how it applies to the community integration with patients that had suffered traumatic     brain injury.   "
250576|NCT01136499|"     The purpose of this study is to assess efficacy and safety of LBH589 - Panobinostat®, a     potent HDACi, in patients with advanced STS who experiment disease progression after or     during first-line chemotherapy. The rational is based on the observation of activity of     deacetylase inhibitor (DACi) in several pre-clinical models of STS including Synovial sarcoma     and Ewing sarcoma.   "
250577|NCT01136512|"     The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on     metformin therapy for diabetes.   "
250578|NCT01124253|"     This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar     prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with     completely resected IB-IIIA non-small-cell lung cancer.   "
250579|NCT01124266|"     Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of     cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality     from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent     retrospective studies have shown that fellow involvement as a second observer may increase     adenoma detection rate in colonoscopy.      The aim of this prospective, multicenter, randomized study is to evaluate the impact when     endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary     outcome measure is the adenoma detection rate (ADR).   "
250580|NCT01124279|"     To determine the bioavailability and the effect of food on the pharmacokinetics under fasted     and fed conditions   "
250581|NCT01124292|"     This study was intended to evaluate a new assistive neuro-technology, known as the Tongue     Drive System (TDS), by its potential end-users, i.e. individuals with severe disabilities,     who are the best experts for indicating the benefits and possible shortcomings of any new     ANT. Our goal is to assess the acceptability and usability of the TDS for various tasks that     are important in daily lives of these individuals, such as computer access, wheeled mobility,     and environmental control.   "
250582|NCT01124305|"     The main purpose of this study is to determine whether the surgical time required for primary     total knee arthroplasty is significantly less when performed with Customized Patient     Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by     video camera, in order to time the length of surgery and each surgical step. The number of     surgical trays required for each case will be recorded. As an additional endpoint, the     investigators will measure limb and component alignment on x-rays to determine if these two     methods achieve equivalent alignment results. The thickness of bone cuts will be compared to     the surgical plan and to each other.      The primary hypothesis is that the use of customized patient instrumentation will reduce the     operative time required for total knee arthroplasty.   "
250583|NCT01124318|"     The purpose is to study efficacy of Lactofiltrum in adult patients with atopic dermatitis.     Lactofiltrum consists of 85% of hidrolytic lignin and 15% of lactulose and acts as an     enterosorbent, which enables to enhance metabolism and elimination of endotoxins and to     normalize metabolic and immune processes. Additionally, lactulose stimulates Bifidobacterium     flora and in aggregate it could improve skin condition afflicted by atopic dermatitis.   "
250584|NCT01124331|"     The primary question to be addressed by this study is: compared with a functional oxygen     saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants     from birth or soon after, result in a difference in mortality or major disability in     survivors by 2 years corrected age (defined as gestational age plus chronological age)?   "
250585|NCT01124344|"     The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe     and tolerable   "
250586|NCT01124357|"     STUDY HYPOTHESIS: Does outpatient NovaSureTM endometrial ablation alleviate excessive     menstrual bleeding and improve life quality more effectively than outpatient ThermachoiceTM     endometrial ablation?   "
250691|NCT01137513|"     The purpose of this study is to measure T-Wave Alternans (TWA) in patients with acute     coronary syndrome. Researchers are blinded to clinical TWA measurements. The investigators     will then try to determine if T-Wave alternans correlates with clinical outcome of patients     with Acute Coronary Syndrome. During routine care of the patient, the T Wave Alternans is     measured.   "
250587|NCT01124370|"     The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve     stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep     fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly     ventricular arrhythmias.      The study is chronic in nature, such that subjects will undergo the implantation of an     implantable pulse generator and stimulation lead. A sensing lead may also be placed during     the initial implant procedure. Subjects will be followed for up to six-months on therapy to     assess respiratory and heart failure outcomes. Following the six-month therapy visit,     subjects will enter into a long-term follow-up phase until the completion of the study.      It is anticipated that data obtained in this study will show that the proposed intervention     can modify respiration with a low incidence of adverse effects. The results of this trial are     intended to be used to develop a subsequent protocol for pivotal study.   "
250588|NCT01124383|"     This study aimed to compare two types of anesthesia (general anesthesia and local anesthesia     with sedation) on the absorption of glycine in operative hysteroscopy.   "
250589|NCT01124396|"     Investigate safety/tolerability after repeated weekly doses intranasal administration of     DSP-3025 comparator placebo to healthy male volunteers   "
250590|NCT01124409|"     This study aims to study the impact image guided radiotherapy with Cone beam CT will have on     the outcomes(toxicities and response) of head and neck cancer when compared to 3D conformal     radiotherapy without CBCT based setup error verification.Also,the various dosimetric     variations in Adaptive RT will be studied.   "
250591|NCT01124422|"     The objective of this study is to demonstrate that, when added to tiotropium (TIO),     fluticasone propionate/salmeterol combination (FSC) DISKUS 250/50 significantly increases     exercise endurance time (EET) in the endurance shuttle walk test (ESWT), compared to TIO     alone. Male and female subjects at least 40 years of age with a diagnosis of Chronic     Obstructive Pulmonary Disease (COPD) are eligible. Subjects will be screened and consented at     or during a 6-week (wk) period prior to visit (V)1. The 4-wk run-in period begins immediately     after V1, when subjects receive open-label TIO plus as-needed relief inhaler (identical     formulations called albuterol in the US and salbutamol in Canada). At V2, subjects will     perform an incremental shuttle walk test (ISWT) to establish their maximal walk response. The     first ESWT will occur at V3. Subjects must demonstrate an EET of ≤20 min that is reproducible     (EET from V3 and V4 varying by ≤2 min). Eligible subjects are then randomized at V5 to either     FSC 250/50mcg DISKUS twice daily plus open label TIO 18 mcg daily, or placebo DISKUS twice     daily plus open label TIO 18 mcg daily for the 4-wk treatment period. The last study visit is     V6. The primary efficacy measure is the difference between the EET at V6 (wk-8) vs. V4 (wk-3;     the last ESWT done before randomized study drug is given). Secondary efficacy measures     include V6 vs. V4 comparisons in exercise dyspnea scale (EDS), exercise inspiratory capacity     (EIC) and cardio-respiratory measurements (CRM), and V6 vs. V5 comparisons in dyspnea related     to activities of daily living (baseline dyspnea index and transition dyspnea index     interviewer-administered [BDI-TDI]) and quality of life (Chronic Respiratory Disease     Questionnaire Self-administered Standardized [CRQ-SAS]). The safety measure will be an     assessment of adverse events. We will also attempt to validate prospectively the minimal     clinically-important difference (MCID) for a change in the EET through correlation with     dyspnea and quality of life results.   "
250592|NCT01124435|"     The aim of this study is to evaluate the antitumor activity and potential adverse effects of     the combination celecoxib plus carboplatin in patients with recurrent, heavily pre-treated     Ovarian Cancer (OC). The potential changes induced by the experimental combination on     angiogenesis-related serum markers and quality of life measures will be also evaluated.The     main objective is to evaluate the response rate. Secondary objectives are the     following:toxicity;progression free survival;overall survival;duration of response;quality of     life;modulation of angiogenesis-related molecules.   "
250593|NCT01124448|"     In this study, the investigators will try to confirm if application of probiotic strains     isolated from breast milk actually have a beneficial effect on women suffering lactational     mastitis. This project has been design to offer an integrated vision of the effects of     probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators     propose a multidisciplinary approach involving the application of microbiological,     immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The     hypothesis is that probiotherapy will cause different effects on the host, and the objective     is the finding of markers that may support the beneficial effect of the strain in such     condition.   "
250594|NCT01124461|"     The goal of this study is to create a comprehensive database of Magnetic Resonance Imaging     (MRI) and of pathology for patients with brain tumors. Both standard, advanced, and research     MRI components may be included, these will be analyzed in comparison with pathology results     if/when a biopsy is obtained, and also used to predict/evaluate responses to therapy. This     study will create a database of de-identified MRI images which include these techniques so     that brain tumors can be studied over time (longitudinally) in an organized manner.   "
250595|NCT01124474|"     This study evaluates whether using information from a special arterial blood pressure monitor     to guide how much fluid is given during surgery changes how long a patient stays in the     hospital after the surgery. There is scientific evidence from using similar information from     different devices that this technique might allow us to do a better job giving fluids during     surgery and that this may be associated with a shorter hospital stay after surgery.   "
250596|NCT01129817|"     A randomized controlled trial of the efficacy of classification based cognitive functional     physiotherapy according to the system proposed by Peter O'Sullivan as compared to manual     therapy and exercise in patients with non specific chronic low back pain.      The investigators hypothesis was that treatment targeted at the mechanism behind the problem     from a multidimensional perspective would be superior to traditional treatment.   "
250597|NCT01129830|"     This prospective study evaluates the effect of DHEA supplementation on markers of ovarian     reserve in women with diminished ovarian reserve.   "
250598|NCT01129843|"     India continues to be one of the countries with very high prevalence of anemia. In fact,     National Family Health Survey-3 (NFHS-3,2005-06) revealed increasing prevalence of anemia in     women and children, since NFHS-2 in 1998-99. In the backdrop of this alarming trend, the aim     of this trial is to assess the effectiveness of a community based anemia management     intervention ( curative and holistic) delivered to rural anemia women and girls(aged 13 years     and above)in remote hilly villages (unit of randomization) in terms of change in anemia     prevalence (unit of analysis) after 3 months of iron supplementation. This trial with a     therapeutic component of Directly Observed Home Based daily Iron Therapy (DOHBIT) by local     village volunteers is conceived as a whole community approach to improve the hemoglobin     status of affected patients in remote villages.   "
250600|NCT01129869|"     Background:        -  Understanding participants experiences as research volunteers is critical to improving          the effectiveness of human participant protection programs and strengthening public          trust in clinical research. Historically, studies that evaluate participants          comprehension of the informed consent document or evaluate the informed consent process          have only indirectly measured the quality of a participant s experience.        -  Few studies have assessed the nature, quality and efficiency of the entire clinical          research process from the participant s perspective. To address this need, researchers          have developed a Clinical Research Participant Perception Survey to evaluate          participants overall perceptions of clinical research.      Objectives:      - To validate the Research Participant Perception Survey questionnaire and revise it     accordingly to produce a questionnaire that other researchers can use.      Eligibility:      - Individuals at least 18 years of age who have participated in at least one research     protocol within the past 2 years. Participation may be completed or ongoing.      Design:        -  Eligible participants will receive a survey by mail and will be asked to complete it and          return it in the stamped envelope provided.        -  The survey will ask questions about the research protocol process, including          participants positive and negative experiences of participating in the research          protocol.   "
250601|NCT01129882|"     Purpose: To continue to provide aripiprazole intramuscular (IM) Depot treatment (400 mg or     300 mg) to subjects with schizophrenia completing the 52-week, open-label safety and     tolerability Study 31-08-248.   "
250602|NCT01129895|"     Promoting Health by Self Experience (PHASE) randomized controlled trial      Study Hypothesis:      A personal experience in health promotion will affect the health prevention activities of the     health providers and thus will impact their prevention activities toward their patients     compared with a control (no-intervention) group.   "
250603|NCT01129908|"     The celiac disease (CD) is a disease with an immune and genetic component that is activated     by the presence of gluten, and damages the intestine mucosa and causes malabsorption of food.      In the oral environment the investigators see enamel defects and recurrent ulcers.      Celiac patients have to keep a restrict gluten-free diet, in order to prevent the clinical     symptoms of the disease (such as diarrhea, stomach ache and weight loss).      It has been assumed that the patients have less cariogenic diet, and that caries prevalence     is not as high as in normal population.      In celiac patients the investigators find enamel defects that are characterized with pits and     deep fissures and sometimes the complete loss of enamel. These defects are classified by the     grading of the CD related DED's (dental enamel defects) according to Aine. These defects are     symmetrical defects in the permanent dentition, in teeth that develops at the same time. The     cause is thought to be hypocalcaemia or genetic.      These defects were found in 42.2% of celiac patients in appose to only 5.4% in healthy     population.      Recurrent ulcers were found in 41% in the oral cavity of celiac patients, compare to 27% in     healthy population.      After changing the diet to a gluten-free diet, an improvement is seen in the presence of     these ulcers.   "
250604|NCT01129921|"     This is a single-center, randomized, prospective, double-blind, clinical study to assess the     clinical application and outcomes with mild® devices versus sham in patients with symptomatic     moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to     cross-over and have the actual decompression procedure after week 6 exam.   "
250605|NCT01129934|"     Acute low back pain is a common cause for emergency department visits. Controversy remains     regarding the optimal medication for acute low back pain relief. The investigators     hypothesized that administration of pharmacological anxiolysis in addition to analgesia will     improve pain relief and patient management in the emergency department.   "
250606|NCT01129947|"     DHEA supplementation has been used in women with infertility and diminished ovarian reserve.     There is a small report in 5 women with POF that benefited from the use of DHEA over several     months. The investigators aim to evaluate further the use of DHEA in women with Premature     ovarian failure (POF).   "
250607|NCT01129960|"     The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate     (ESL) as therapy in subjects with Diabetic Neuropathic Pain (DNP) over a 15 week treatment     phase.   "
250608|NCT01129973|"     the audiology has achieved a great advance, where currently speech pathologists act in     private clinics and in public services, in addition to schools, colleges and universities. To     observe the development of the area of Audiology in Brazil, we note that there is a growing     number of new audiology procedures. In 1980 the practice of audiology was limited in     hospitals, offices and private clinics, and in 1988 due to a new constitution that devoted     attention to protection of health of workers, opened-if more than one field of work, the     audiology occupational, because of the hearing losses induced by noise   "
250609|NCT01129986|"     An open-label, prospective, controlled, two-step approach, post-marketing clinical study,     applying DermaStream with saline streaming, in conjunction with a sustained multi-compression     wrap, on healthy individuals and on patients with a venous stasis ulcer of the lower     extremity.   "
250610|NCT01129999|"     Intensive cognitive-behaviour interventions (CBT) combined with pharmacotherapy for smoking     cessation are well established and have been proved to be efficacious. Nevertheless, they     yield only long-term abstinence rates about 35%. Considering the high interest of smokers in     alternative medicine, the availability of a broad range of treatment methods, of which     smokers choose an intervention according to their preferences, might contribute to improve     treatment outcome. While hypnotherapy (HT) is an already widely promoted alternative method     for aiding cessation, considerable methodological shortcomings of studies on this topic limit     the interpretability of the results. In 2006, the German Academic Advisory Committee for     Psychotherapy released new guidelines that included HT as an acceptable treatment for smoking     cessation. The committee conceded, however, that conclusions concerning its efficacy are     restricted due to the heterogeneity of findings. Hence, further well-designed studies are     required to better test the efficacy of HT in comparison to accepted treatments. This     randomised, controlled trial aims to compare the efficacy of CBT and HT for smoking     cessation. Further, the influence of moderating variables will be investigated. It is     hypothesized that 1) participants receiving CBT will evince higher abstinence rates than     those receiving HT, 2) levels of nicotine dependence, self-efficacy and motivation to change     will moderate the intervention effects and 3) participants with high levels of suggestibility     will evince higher abstinence rates in the HT-intervention compared to participants with low     levels of suggestibility. 220 adult healthy smokers will be randomized to receive either CBT     or HT. Both programmes will be conducted in 6, weekly, 90-minute group sessions. Participants     will be followed up at 1, 3, 6, 9 und 12 month post-treatment. Generalized estimating     equation models will be conducted to analyse group differences on abstinence rates. The     models will include the above mentioned moderator variables.   "
250613|NCT01130038|"     There will be found differences in the issue of characteristic of play between Children with     Development Coordination Disorder and Children with Typical Development.   "
250614|NCT01130051|"     The purpose of this study is to evaluate and compare the relative bioavailability of a single     0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1     tablespoon) relative to the same dose given as an intact tablet to healthy subjects following     an overnight fast. A secondary objective is to evaluate the safety and tolerability of this     regimen in healthy volunteers. All study subjects will be monitored for adverse events     throughout the study period.   "
250615|NCT01130064|"     The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment     with QAX576 in patients with persistent asthma not adequately controlled with inhaled     corticosteroids and long acting beta2-agonists.   "
250616|NCT01130077|"     The overall objective of this pilot study is to collect immunological and safety data     following administration of vaccinations with HLA-A2. This data will be used to decide     whether a larger study of clinical efficacy is warranted.   "
250617|NCT01130090|"     In patients under bi-level pressure support ventilation for obesity hypoventilation syndrome,     this study aims to determine if it is better, in terms of efficacy and patient-ventilator     synchronisation to use        -  Spontaneous mode (S)        -  Spontaneous/Timed mode (ST) with an intermediate back-up rate, slightly below the          respiratory rate of the patient        -  Timed mode (T), with a ventilator respiratory rate above that of the patient. This issue          has to our knowledge only been marginally studied without any consensus.   "
250618|NCT01130103|"     This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and     the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of     the World Trade Center (WTC) attacks.   "
250619|NCT01130129|"     Consumption of a diet rich in fruit and vegetables is associated with a reduced risk of     cardiovascular disease and the protective effect may be due to polyphenolic compounds     contained within these foods. The mechanism by which polyphenols exert this effect is not     clearly understood but research has focused on their potential to affect platelet function.     The purpose of this study is to quantify the anti-clotting activity of a range of plant food     extracts and component compounds.   "
250620|NCT01130142|"     Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with     gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is     designed as a dose escalation study. Once the maximum tolerated dose of IPI-926 in     combination with gemcitabine is established in the Phase 1b portion of the study, the Phase 2     portion will commence.      Phase 2 is designed as a randomized, double-blind (investigator/patient), placebo-controlled     study. There is no cross-over option for patients in either arm of the Phase 2 (i.e., there     is no option for patients receiving placebo to cross-over to IPI-926).   "
250621|NCT01130155|"     It is generally agreed that artemisinin-based combination therapy (ACT) is the malaria     therapy of choice but there is much less agreement about the best ACT-deployment strategies.     Countries are now beginning to adopt policies to enhance ACT deployment that aim to address 2     key goals: (i) making ACTs more readily and speedily accessible to patients: or (ii)     targeting ACTs to patients shown to have malaria parasitaemia.      The Tanzanian Government has secured funding to address both ACT access and targeting on a     national scale. Access is to be improved through the distribution of subsidised ACTs through     private facilities and retail drug shops under the Affordable Medicines Facility-malaria     (AMFm). Targeting is to be addressed through enhancing microscopy and introducing rapid     diagnostic tests (RDTs) in health facilities at every level of the system.      This study will evaluate these two interventions in 3 rural regions of Tanzania which are all     expected to receive both interventions during the study period. The investigators will assess     the effectiveness of the interventions in terms of coverage, equity, quality, adherence, and     public health impact using a pre-post plausibility design based on before and after     household, health facility and outlet surveys. The null hypothesis is that the interventions     will have no impact on the coverage of prompt effective treatment for fever and malarial. In     addition, the investigators will estimate the cost and cost-effectiveness of implementation     from a health system and household perspective. Finally the investigators will explore the     socio-cultural context and other factors that influence the implementation and outcome of the     interventions.   "
250622|NCT01130168|"     This study will test the relationship between CBP (central blood pressure) and PBP     (peripheral blood pressure) effects after single and multiple doses of Isosorbide mononitrate     extended release (ISMN ER) or Amlodipine besylate in participants with hypertension.   "
250623|NCT01130181|"     Study hypothesis:      High-dose vitamin D leads to a shorter hospital stay in critically ill patients      Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol     or placebo.   "
250624|NCT01130194|"     Follicular lymphoma has historically been considered an incurable lymphoma. By combining     multiple effective treatments, the investigators believe that prolonged disease-free survival     is achievable in this disease. The investigators goal is to have at least 60-70% of our     patients in first continuous complete remission 15 years from initiation of treatment.   "
250625|NCT01130207|"     The investigators will study people who are obese and will be treated by bariatric surgery.     The investigators will test the hypothesis that some of the features of obesity are related     to the bacteria in the gastro-intestinal tract.   "
250626|NCT01130220|"     The purpose of this research is to explore the factors involved in brain cancer health care     literacy needs.   "
250627|NCT01130233|"     Hypothesis: the bladder and sexual functions can be better preserved in patients with robotic     assisted rectal surgery      This is a randomized trial comparing the bladder and sexual function of patients who undergo     laparoscopic and robotic assisted rectal resection for rectal cancer.   "
250628|NCT01130246|"     The objective of this study is to evaluate the safety and efficacy of short-term A-002     treatment on morbidity and mortality when added to atorvastatin and standard of care in     subjects with an acute coronary syndrome (ACS).   "
250639|NCT01130402|"     The investigaotors want to establish a real-time and computerized score reporting system     based on the significant predictors of the measured sonographic parameters and demographic     data.   "
250640|NCT01130415|"     The purpose of this study was to evaluate whether there is a difference in long-term outcome     between patients screened with the percutaneous nerve evaluation (PNE) and first stage tined     lead procedure (TLP).   "
250629|NCT01130259|"     The following trial is designed to offer pre-approval drug access to iniparib in combination     with gemcitabine and carboplatin in order to provide potential clinical benefit to patients     with ER-, PR-, and HER2-negative metastatic breast cancer. This follows an ongoing Phase 3,     multi-center, open-label, randomized study of gemcitabine/carboplatin, with or without     iniparib, in patients with ER-, PR-, and HER2-negative metastatic breast cancer (protocol     20090301).      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
250630|NCT01130272|"     The purpose of this study is to determine the efficacy, safety, and tolerability of different     doses of JNJ-27018966 compared with placebo in the treatment of patients with irritable bowel     syndrome with diarrhea (IBS-d).   "
250631|NCT01130285|"     The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test     (LCRT). In the process, the investigators will establish a bank of NBEC samples and     corresponding blood samples from individuals demographically at increased risk for lung     cancer.   "
250632|NCT01130298|"     Single-center, single dose, open-label study in healthy male and female volunteers to further     characterize the transfer potential of Testosterone Gel 1.62% formulation.   "
250633|NCT01130311|"     Tuberculosis is a global public health problem. One third of the world's population is     infected with tuberculosis (TB) with almost 2 million deaths per year globally. According to     the WHO, Pakistan ranks 8th amongst the 22 high TB burden countries, with an estimated     prevalence is 263 cases /100,000 populations.      In spite of effective therapy for drug sensitive TB, treatment failure occurs frequently     leading to concerns for the emergence of multi-drug resistant (MDR) and extensively drug     resistant (XDR) mycobacterial strains. Therefore in the recent years, interest has been     generated regarding the role of adjuvant immunomodulating therapy for the treatment of TB.      WHO has classified tuberculosis by disease severity into 3 distinct categories; mild,     moderate and severe according to clinical presentations and host factors. Severity of disease     has been linked to mycobacterium genotypes and with host factors such as vitamin D deficiency      Vitamin D is a hormone produced by the body in response to sun exposure. Independent of it's     effects on bone mineralization, vitamin D is recognized to have numerous immune modulating     effects; some specific to mycobacterium tuberculosis. Therefore vitamin D may enhance the     host immune responses against the pathogen. Vitamin D status can be accurately determined by     measuring the serum levels of 25-(OH) D3. A recent systemic review and meta-analysis explored     the association between low serum vitamin D and risk of active tuberculosis and concluded     that patients with tuberculosis have lower serum levels of vitamin D than healthy controls     when matched for sex, age, ethnicity, diet and geographical location.      Vitamin D deficiency is not a life threatening condition. It usually is unrecognized or can     present with generalized 'aches and pains' due to osteomalacia. The recommended dose for     treatment of vitamin D deficiency is 200,000 IU/ month or 50,000 IU/ week, both given for 2     months or until the serum vitamin D level is > 30 ng/ml. Bone mineral density changes are     usually completed by 10 weeks of treatment.      The investigators hypothesize that by replacing vitamin D in patients with active pulmonary     tuberculosis, the 'Time to Recovery' can be shortened.Our aims are to determine whether     replacing patients with insufficient and deficient levels of vitamin D affects the clinical     outcome of the disease.   "
250634|NCT01130324|"     The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to     VIBATIV at any time during pregnancy. There are no mandated physician visits for the     registry.   "
250635|NCT01130337|"     This study will evaluate the disease free survival rate of a combination of capecitabine     [Xeloda] and oxaliplatin (XELOX) with trastuzumab [Herceptin] in patients with resectable     gastric cancer. The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and     Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle)     will be administered for three cycles prior to surgery to resect the tumor. If complete     resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three     cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin     alone. Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day 1 in     every cycle. The anticipated time on study drug will be 12 months.   "
250636|NCT01130363|"     The class of proton pump inhibitor (PPI) medications such as omeprazole has proven extremely     effective in the treatment and prevention of gastric and duodenal ulcers. Although the FDA     approval for PPI therapy is limited to 6-8 weeks, many individuals remain on these agents for     years, and human studies have suggested that long-term use of a PPI can result in     enterochromaffin-like (ECL) cell hyperplasia, as well as being associated with the     development of fundic-gland polyps of the stomach. These findings raise the concern of the     possibility that long-term use of PPIs may predispose to the development of neuroendocrine     tumors in patients. The investigators aim to examine clinical parameters, including history     of PPI use and fasting gastrin levels, as well as histologic characteristics (particularly     the presence of ECL-cell hyperplasia) of patients found to have fundic gland polyps during     endoscopy. The investigators hypothesize that there is a correlation between fundic gland     polyps of the stomach and the use of proton pump inhibiter medications.   "
250637|NCT01130376|"     For several years there has been interest in why some people with HIV-1 progress more slowly     to disease and have longer survival without Highly Active Antiretroviral Therapy (HAART) than     others. The investigators and others have identified a few HIV positive individuals who can     control their viral load for many years without HAART, these rare individuals do not lose     their HIV-1-specific cellular immune responses, which are very important for controlling     viral load. This group is referred to as long-term non-progressors (LTNP). Unlike LTNP the     majority of HIV-1 infected individuals are chronic progressors (CP) who do not make effective     HIV-1-specific cellular immune responses, even when on HAART. We propose to use a novel DNA     vaccine boosted with immune based therapy (cytokines and hormones) to try to regenerate the     missing HIV-1-specific cellular immune responses to make chronically infected HIV-1+ persons     more like LTNP.      By injecting this novel DNA vaccine and immune based therapy into the people who are already     infected with HIV-1, the immune system may be stimulated to mount a greater immune response     not only to the vaccines but also to real HIV-1 particles and HIV-1-infected cells.   "
250638|NCT01130389|"     The purpose of this study was to examine risk factors for osteonecrosis of the jaw (ONJ),     including the possible association with bisphosphonates (BPs). This study used the research     infrastructure from the three NIDCR-funded dental practice-based research networks (DPBRN,     PEARL, PRECEDENT). De-identified data from the DPBRN were merged with comparable     de-identified data from PEARL and PRECEDENT to form a single trans-PBRN data set used for     analysis.   "
250641|NCT01130428|"     Rationale: Mechanical loading is well-known to have a strong anabolic effect on bone. It has     therefore been proposed that a mechanical intervention could be an effective     non-pharmacological approach to treat bone loss associated with conditions such as osteopenia     and osteoporosis. Data from in vitro experiments indicate that the purine nucleotide     adenosine 5'-triphosphate (ATP) is released by bone cells and mediates cellular crosstalk via     P2 purinergic receptors in response to mechanical stimulation. ATP release by bone cells may     thus be part of a general mechanism by which mechanical loading ultimately results in     increased bone formation, but this remains to be investigated in humans in vivo. The     investigators hypothesize that a mechanical intervention in humans leads to a rise in     systemic ATP concentrations due to ATP release from bone.      Objective: To investigate in vivo whether a measurable increase in systemic ATP levels occurs     in response to mechanical stimulation of bone in humans.      Study design: Intervention study with a non-randomized, non-blinded design. All subjects will     participate in a single experiment, lasting approximately 3 hours, during which the subjects     will receive a mechanical intervention at a fixed dose.      Study population: Maximally 10 healthy human volunteers (18-35 y). Intervention: Subjects     will receive a gentle and safe mechanical intervention, which will be administered by means     of a Juvent 1000 Vibration Platform delivering low-magnitude mechanical stimuli (i.e.     vibrations) to the forearm. The mechanical stimulation will be administered at a frequency of     90 Hz and amplitude of 10 µm in an intermittent fashion, i.e. three 10-minute periods of     stimulation with 10-minute rest periods in between.      Main outcome parameters: As the primary outcome parameter, a change in extracellular ATP     concentrations as a result of the mechanical intervention will be assessed systemically.   "
250642|NCT01130441|"     Incarcerated adolescents engage in suicide ideation, self-harming behaviors and have poor     coping abilities, suggesting a need for mental health intervention and treatment. Previous     research on self-harm among community adolescents revealed that self-harmers were more likely     than non-self-harmers to report suicidal ideation, and having made a suicide plan.      This study plans to evaluate the suicidal intent of self-harming and non-self harming     adolescent admitted at juvenile detention house in Taiwan. Furthermore, this study also plans     to identify the prevalence and types of self-harming activities of incarcerated youths.     Another purpose is to investigate the coping abilities of incarcerated youth, with evaluation     of efficacy of short problem-solving skills therapy intervention by trained psychologists of     three sessions for adolescents with poor coping adjustment; referral to adolescent     psychiatrist when severe mental disorder or poor coping abilities were found.      By analyzing their suicidal ideation, self-harming behaviors, and coping adjustment, the     investigators will be able to give timely intervention and identify effective means and     methods for better serving this population. This study hopes to help the incarcerated youth     to replace their self-destructive behaviors with effective coping adjustment abilities.   "
250643|NCT01130454|"     The objective of the study is to determine if one 45-minute treatment with the SCIO     (Scientific Consciousness Interface Operations System) biofeedback device would show a     change, and hopefully an improvement, on a person's Body Wellness indicators (Quality of Life     Questionnaire, Energy Index Factor, Strength, Oxidation, Flexibility, Memory, pH, and VARHOPE     scores (V=voltage, A=amperage, R=resistance, H=hydration, O=oxygenation, P=proton pressure     and E=electron pressure), electrical measures within the device. For subjects in the control     group, it is expected that there will likely be an improvement of approximately 5% in     measured variables. That is, subjects in the control group will likely report some of the     positive changes listed above for test group subjects. However, on average, any positive     change in post-treatment measures for control subjects is expected to occur to a     significantly lesser degree than for subjects in the test group.   "
250644|NCT01130467|"     The investigators try to objectively and scientifically explore various brain function     impairments in ADHD children by electrophysiologic tests, with and without medication.   "
250645|NCT01130480|"     COMPASS is a status and intervention study for the self-monitoring of blood glucose (SMBG) in     type 2 diabetic patients with insulin treatment. This multi-centre, open-label prospective     study will assess the use and frequency of SMBG and blood glucose control and its influencing     factors with the help of Accu-Chek Integra glucometer. Patients with type 2 diabetes mellitus     who have received more than 3 months of insulin therapy are eligible to participate in this     study. The anticipated duration of the study is 6 months.   "
250646|NCT01130493|"     This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced     Parkinson's disease.   "
250647|NCT01130506|"     This phase I trial studies the side effects and the best dose of cytarabine when given     together with decitabine and vorinostat in treating patients with acute myeloid leukemia or     myelodysplastic syndrome that has returned or has not responded to treatment. Drugs used in     chemotherapy, such as cytarabine and decitabine, work in different ways to stop the growth of     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Vorinostat may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Giving cytarabine together with decitabine and vorinostat may     kill more cancer cells.   "
250648|NCT01130519|"     Background:        -  At the present time, there are no drugs that have been proven to work in patients with          papillary kidney cancer that has spread (metastasized) beyond the kidneys. Researchers          are interested in determining whether the combination of the drugs bevacizumab and          erlotinib can be used to treat metastatic papillary kidney cancer.        -  Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC) is an inherited type of          papillary kidney cancer (it runs in families). Papillary kidney cancer can also occur          sporadically, or without a family connection. More research is needed to determine          whether treatments for papillary kidney cancer, such as bevacizumab and erlotinib, work          in inherited or sporadic types of kidney cancer, and if so, whether there are any          differences.      Objectives:      -To determine the effectiveness of the combination of bevacizumab and erlotinib as a     treatment for patients with (1) metastatic HLRCC kidney cancer and (2) metastatic kidney     cancer not associated with HLRCC (or sporadic papillary RCC).      Eligibility:        -  Individuals 18 years of age or older who have been diagnosed with papillary kidney          cancer that has spread beyond the kidneys.        -  Participants may have either HLRCC or sporadic papillary kidney cancer.      Design:        -  Participants will be screened with a full medical history, physical examination, blood          and urine tests, and CT and other scans to evaluate tumor size and treatment options.        -  Participants will receive 28-day treatment cycles of bevacizumab (given intravenously          every 2 weeks) and erlotinib (a tablet taken by mouth daily).        -  Every cycle, participants will return for regular blood and urine tests. Every other          cycle, participants will have imaging scans to assess tumor size and response to          treatment. Female participants who have uterine fibroid tumors related to their kidney          cancer may have additional scans to assess tumor size and response to treatment.        -  Participants will continue to receive treatment on the study until their tumors grow or          spread to new areas (disease progression), intolerable side effects develop, a better          treatment option becomes available, the study closes, it is unsafe to continue          treatment, or the participant decides not to remain in the study.   "
250649|NCT01130532|"     The purpose of this trial is to evaluate if treatment with tadalafil once daily will allow     men to return to normal erectile function in those who did not have normal erectile function     following as-needed (PRN) Phosphodiesterase Type 5 (PDE5) Inhibitor treatment.   "
250675|NCT01136668|"     The primary objective of this study is to determine if the use of Transversus Abdominis Plane     (TAP) blocks reduce early postoperative opioid requirements.   "
250762|NCT01138436|"     This is a Phase II, randomized, controlled, two-center pilot study designed to assess the     safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry     criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either     MEBO or SOC (7 subjects per treatment arm).   "
250650|NCT01130545|"     Background:      - Magnetic resonance imaging (MRI) scans must be performed according to specified sets of     parameters that provide optimal images of each organ and each area of the body. These     scanning parameters are often specific to the institution or organization at which they are     employed, and may also depend on the manufacturer of the MRI scanning equipment. Because MRI     scanning equipment is always being updated and upgraded, researchers are interested in     developing new and optimized scanning parameters for MRI scans.      Objectives:      - To improve current methods and develop new techniques for magnetic resonance imaging.      Eligibility:        -  Individuals 18 years of age and older who are either volunteers or current NIH protocol          participants.        -  Participants must not have any medical history factors (e.g., extreme claustrophobia,          history of metal implants) that would prevent them from receiving MRI scans.      Design:        -  Participants will have at least one MRI scan that will last from 20 minutes to 2 hours          (most scans will last between 45 and 90 minutes). The total time commitment for most          visits will be approximately 4 hours from start to finish.        -  Some MRI techniques require standard monitoring equipment or specific procedures during          the scanning, such as an electrocardiogram.        -  Participants will have blood samples taken at the time of the scan. Some MRI studies          will require the use of a contrast agent that will be administered during the scan.        -  Volunteers may be asked to return for additional MRI scans over the course of a few          years. Follow-up scans may be done on the same part of the body or on different parts of          the body. No more than one MRI scan will be performed in any 4-week period for this          protocol.   "
250651|NCT01130558|"     The purpose of this study is to determine whether an electronic order template for     basal-bolus insulin will improve mean blood glucose in hospitalized general medical patients     with poorly controlled type 2 diabetes.   "
250652|NCT01130571|"     Xenografts and cell cultures provide sufficient material for analyses at the protein, RNA and     DNA level. Patient derived NSCLC xenografts and cell lines are available but none however are     Asian in origin. Given the emerging evidence to suggest inter-ethnic differences in NSCLC     biology, new models of preclinical drug evaluation should be designed and validated using     Asian tumors. Furthermore, such models will allow studies of biological mechanisms of     sensitivity and/or resistance and also the study of dynamic regulations under standardized     conditions in the Asian context.   "
250653|NCT01130584|"     The purpose of this study is to determine if pyruvate kinase M2 (PKM2) can be used as a     biomarker in cancer.      Pyruvate kinase M2 is more elevated in malignant pleural fluid than in plasma, and may be a     useful biomarker to distinguish between malignant and non-malignant causes of pleural     effusion. In addition, pyruvate kinase M2 has also been found to be elevated in saliva in     cancer patients compared to controls. Measuring pyruvate kinase M2 in saliva may be used to     diagnose cancer or monitor the treatment progress of cancer.   "
250654|NCT01130597|"     The purpose of this study was to evaluate the feasibility of individualized titration of     patiromer according to serum potassium. This study also assessed the safety and tolerability     of patiromer and the effects of patiromer on serum potassium in heart failure (HF)     participants with chronic kidney disease (CKD).   "
250655|NCT01130610|"     Study conducted in large Brazilian hospital, with the main objective of evaluating the impact     of pre-anesthetic in reducing costs related to the preoperative preparation of patients     admitted to undergo surgery or diagnostic procedures under anesthesia.   "
250656|NCT01130623|"     Background:      - Pazopanib, a drug that inhibits the growth of new blood vessels in tumors, was recently     approved by the Food and Drug Administration to treat advanced kidney cancer in adults.     Pazopanib has been used in only a small number of adults, and more research is needed on     whether it is safe and effective to use in children. Researchers are interested in     determining safe and effective treatment doses of pazopanib in children, and in other studies     will examine which form of pazopanib treatment (tablet or liquid) is most effective and well     tolerated.      Objectives:        -  To determine a safe and effective dose of pazopanib to treat solid tumors in children.        -  To study the effects of pazopanib on blood cells, blood flow, and human development.      Eligibility:      - Children, adolescents, and young adults between 1 and 21 years of age who have been     diagnosed with solid tumors that have not responded to treatment.      Design:        -  Eligible participants will be screened with a physical examination, blood and tumor          samples, and imaging studies.        -  Participants will receive pazopanib tablets for 28-day cycles of treatment. Pazopanib          should be taken on an empty stomach, at least 1hour before or 2 hours after a meal.          Participants may receive pazopanib for up to 24 cycles unless the tumor does not respond          or participants develop serious side effects.        -  Blood samples will be taken on days 1, 15, 22, and 27 of the first cycle of pazopanib,          with additional samples taken every 8 weeks during subsequent cycles.        -  An optional part of the study will collect additional blood samples at regular intervals          for 24 hours after the first dose of pazopanib and at regular intervals after another          dose during the second or third week of the first treatment cycle.   "
250657|NCT01130636|"     The main purpose of this study is to assess the potential exposure of neonates to oseltamivir     during lactation by examining oseltamivir concentrations in maternal blood, urine, and breast     milk in breastfeeding women who are treated with oseltamivir, an anti-flu medication.   "
250658|NCT01130649|"     The investigators propose a novel method for tracking the seizure frequency, side effect     burden, and medication compliance for patients with epilepsy. The investigators intend to     utilize a table-top device currently for tracking other chronic disease to collect remote     data from epilepsy patients. The hypothesis is that the use of this device will lead to     better longterm treatment outcomes than the standard outpatient mechanism of following     patients longitudinally.   "
250659|NCT01130662|"     The purpose of this study is to determine the tolerated dose of the combination of decitabine     and midostaurin as induction (first cycle of chemotherapy) and consolidation (additional     chemotherapy once a patient goes into remission) in people greater than 60 years with newly     diagnosed AML or adult patients with relapsed/refractory disease.   "
250660|NCT01130675|"     The purpose of this study is to determine if consuming an 8 ounce cup of coffee with     breakfast and lunch is effective in preventing or reducing postoperative ileus.   "
250692|NCT01137526|"     The purpose of this study is to test if the investigational medication, ABT-384, is a safe     and effective treatment for adults with mild-to-moderate Alzheimer's Disease.   "
250661|NCT01130688|"     The leukemic stem cells (LSCs) are cells that self- renew and give rise to leukemia.     Eradication of LSC is required for cure. In chronic myelogenous leukemia (CML) LSCs are not     eradicated by imatinib (Gleevec) alone. Recent discovery by Dr. Shaoguang Li at University of     Massachusetts indicates that the LSCs can be targeted by a new drug zileuton (Chen et al.     Nature Genetics 2009; 41:783-792). Zileuton (approved for asthma) will be tested in a     combination with Gleevec. This combination has not been used previously to treat leukemia.      This is a Phase I study. The goal of this research is to evaluate the safety of the standard     anti-cancer drug imatinib and experimental drug zileuton.   "
250662|NCT01130701|"     In this study, a new chemotherapeutic agent, panitumumab, will be tested in combination with     another chemotherapeutic drug, capecitabine, along with external radiotherapy, to find out     whether this combination is effective and safe to use before surgery.   "
250663|NCT01130714|"     The purpose of this study is to examine the effectiveness of a resistance training program on     reducing systemic inflammation and improving chemotherapy completion in lung cancer patients     being treated with curative intent chemotherapy.   "
250664|NCT01136525|"     The purpose of this study is to        1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl          tablets of Dr. Reddy's and Valtrex (R)(Valacyclovir Hydrochloride)CAPLETS 1 gram of          GlaxoSmithkline, in healthy, adult human subjects under fasting conditions.        2. monitor the adverse events and ensure the safety of subjects.   "
250665|NCT01136538|"     The purpose of this study is to        1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl          tablets of Dr. Reddy's and Valtrex (R)(Valacyclovir Hydrochloride)CAPLETS 1 gram of          GlaxoSmithkline, in healthy, adult human subjects under fed conditions.        2. monitor the adverse events and ensure the safety of subjects.   "
250666|NCT01136551|"     The purpose of this study is to develop oral controlled release formulation of Huperzine A     that will provide optimal pharmacokinetic profile of the drug enhancing safety and     compliance, as possible cure to neurodegenerative disorders.   "
250667|NCT01136564|"     Recently it has been documented that vitamin D has important functions in the human body that     are unrelated to its primary effects in calcium homeostasis and bone mineralization. In     clinical studies, paricalcitol - a low-calcemic vitamin D analogue - has been shown to     decrease proteinuria, a marker of disease progression and cardiovascular risk in patients     with chronic kidney disease (CKD). The purpose of this study is to investigate the effect of     a paricalcitol on renal and cardiovascular variables in patients with moderate to severe CKD.   "
250668|NCT01136577|"     Phototherapy is almost (beside exchange transfusion) the unique treatment for     hyperbilirubinemia of the newborn. Its efficacy to decrease bilirubin level (because the     light interacts with bilirubin at the skin level to transform it in water soluble products     eliminated in urine and stools without liver metabolism) relies on the irradiance dispensed     at the skin level by the device (in the 430-490nm range) and on the exposed surface of the     baby. In the past years, technology of phototherapy devices moved from fluorescent lamps to     LED, improving the amount of light energy emitted but on a smaller surface. The purpose of     the study is to compare the efficacy of three ramps of phototherapy, one equipped with     fluorescent tubes and two with LED (in a different technological settings) in the treatment     of term (35 GW or more) healthy newborn suffering hyperbilirubinemia after 2days of life.   "
250669|NCT01136590|"     Current evidence regarding the efficacy and safety of perioperative administration of     tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal     surgery.      OBJECTIVES: To evaluate the effectiveness of tranexamic acid for decreasing transfusion     requirements and bleeding in this patient population. To evaluate the safety of this     antifibrinolytic agent in the intraoperative and mid-term postoperative period.      METHODS: Multicenter, randomized, double-blind, placebo-controlled clinical trial with     parallel groups. The main outcome measure is intraoperative and postoperative transfusion     requirements; blood loss and safety will also be evaluated. Previous results in other types     of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss.     Hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood     loss in comparison to a placebo in major spine surgery.   "
250670|NCT01136603|"     Hypothesis: TIGR mesh as a reconstruction material is a more effective mesh for the repair of     the abdominal wall post lipectomy, transverse rectus abdominis myocutaneous (TRAM) / deep     inferior epigastric perforator (DIEP) flap.   "
250671|NCT01136616|"     Hypothesis: There are 5 support buttresses in the complex osteocartilaginous architecture of     the nose.        1. The membranous septum;        2. The Right nasal bone;        3. The Left nasal bone;        4. The perpendicular plate of the ethmoid;        5. The vomer, vomerine groove and anterior nasal spine.   "
250672|NCT01136629|"     Hypothesis -      The developments of solar lentigine and melasma are due to mutations in keratinocytes that     drive the production and transfer of pigment from melanocytes to keratinocytes.   "
250673|NCT01136642|"     Background:        -  Smoking is the leading cause of preventable death in the United States, and researchers          are interested in gaining a better understanding of the perceived beneficial effects of          nicotine to help improve treatment strategies for nicotine dependence. Understanding the          conditions under which nicotine improves attention and cognitive processing may provide          more useful information for this research.        -  The ability to pay attention and filter relevant from irrelevant stimuli is central to          all aspects of information-processing. Top-down and bottom-up attentional processes          illustrate how the brain combines stimuli and goal-directed behaviors. Bottom-up          processing is an unconscious response to sensory input; for instance, when the eyes          automatically focus on a prominent image in a picture. Top-down processing is a          conscious response to drive attention toward specific stimuli; for instance, when a          person is asked to focus on a less immediately noticeable image in a picture.          Researchers are interested in determining whether nicotine improves cognitive          performance by acting on top-down or bottom-up attentional mechanisms.      Objectives:      - To investigate the effect of nicotine on the top-down and bottom-up mechanisms of attention     in cigarette smokers.      Eligibility:      - Current smokers (at least 10 cigarettes per day for at least 1 year) between 18 and 55     years of age.      Design:        -  This study will involve one training session and four experimental sessions.        -  During the training session, participants will receive a sample dose of the nicotine          nasal spray used in the study to determine if they can tolerate the effects.        -  For each experimental session, participants will receive one dose of nicotine nasal          spray (1 mg, 2 mg, or 3 mg) or placebo spray, followed by blood pressure and heart rate          monitoring, performance of an attentional test, and questionnaires to rate participants          perception of nicotine effectiveness. Participants may receive different doses at          different sessions, and will not be told which dose they will receive at any given          point.   "
250674|NCT01136655|"     This purpose of the study is to investigate the bronchodilating effects of 3 different     dosages of formoterol given in combination with budesonide as Symbicort pMDI.   "
250676|NCT01136681|"     The investigators are developing a research platform capable of improving children's health     through the generation of knowledge from analysis of routinely collected data from within and     outside the health service.      The investigators are using the data that are routinely collected in Wales to answer specific     questions about child health and well-being, with the aim of informing policy and practice in     Wales, whilst also being internationally relevant.      Routinely collected datasets are publicly funded, and have already been incorporated into the     Secure Anonymised Information Linkage databank. The investigators are combining these     datasets on children from health and social care to establish an anonymised Wales wide     Electronic Cohort for Children (WECC). WECC will serve as the platform for future work in     translating information into child population health policy.      There are 35,000 births in Wales per year, and data are available for the previous ten years.     Thus, WECC will be sufficiently powered to answer important social, economic and health     policy questions. WECC will also act as a demonstration project which would inform the     development of e-cohorts to support translational research across the life course and disease     spectrum.   "
250677|NCT01136694|"     The purpose of this study is to explore the differences in productivity loss and costs     between patients being treated for rheumatoid arthritis (RA) with biologic disease-modifying     antirheumatic drugs (bDMARDs) compared to patients treated with conventional DMARDs.   "
250678|NCT01136707|"     The purpose of this study is to examine the relationship between loading dose and adherence     to Orencia.   "
250679|NCT01136720|"     18F-FDG produced in the MIRC NS has a similar safety profile to the same compound utilized     elsewhere in that no significant adverse events will occur during observation of the patients     for 2 1/2 hours post injection of the tracer. It is also hypothesized that as this FDG     produced by similar methodology and its quality assurance assessed as in another     jurisdictions will have similar performance parameters in patients with focal lung pathology     to that previously determined.   "
250680|NCT01136733|"     This is an open-label, multicenter, Phase 1b/2 study of lenvatinib alone and in combination     with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma     following one prior VEGF-targeted treatment.   "
250681|NCT01136746|"     The purpose of this study is to compare the use of insulin glargine plus insulin lispro to     human regular insulin for treatment of hyperglycemia in the hospital setting in patients     without known prior history of diabetes.   "
250682|NCT01136759|"     Tenofovir 1% gel is an investigational vaginal microbicide intended to reduce the risk of     transmission of HIV. Pregnant women and mothers who have recently given birth often maintain     sexual activity, and research has shown that they may be at greater risk of HIV infection     during pregnancy. Microbicides may be able to prevent HIV infection during pregnancy, which     would also prevent fetal exposure to HIV. This study will test the safety of using tenofovir     1% gel in healthy, pregnant women and healthy, breastfeeding women.   "
250683|NCT01136772|"     The purpose of this research study is to compare the real-world effectiveness of two     FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone     palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective     disorder who are expected to benefit from the improved medication compliance associated with     injectable medications. The goal is to evaluate the effects of the medications on outcomes of     importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy     makers (all of the above plus costs).   "
250684|NCT01136785|"     The overall goal of the proposed protocol is to rigorously test the hypothesis that CPAP     treatment has beneficial effects on glycemic control in patients with both type 2 diabetes     (T2DM) and obstructive sleep apnea (OSA). If our hypothesis were to be proven, this would     imply that CPAP treatment of OSA in patients with T2DM is an essential component of their     glycemic control. The proposed work is thus expected to provide additional preventive and     therapeutic approaches in the management of millions of patients with T2DM.   "
250685|NCT01136798|"     The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment     in patients with type 2 diabetes results in improved sleep duration and quality and to     explore the relationship between improvements in sleep and measures of metabolic and     circadian function. This project would be the first to probe the relationship between     incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian     dysfunction in diabetic patients.   "
250686|NCT01136811|"     The purpose of this study is to evaluate the preliminary safety and efficacy of the daVinci     surgical system (computer-assisted surgery) for use in vascular surgery procedures. Although     the daVinci Surgical System is FDA approved and widely used for surgical procedures for     urology, cardiac, general, and gynecologic procedures, it is not currently approved     specifically for use in vascular surgery and the FDA has required the PI to conduct a small     feasibility study under an IDE. The investigators are seeking approval by the FDA to utilize     the daVinci Surgical System in vascular surgery and to conduct a future clinical trial.   "
250687|NCT01136824|"     Assessments (survey data) in this study are designed to sample the symptom burden of patients     undergoing adjuvant and neoadjuvant chemotherapy in the hospital. There will be no change in     the treatment plan for these patients.   "
250688|NCT01136837|"     To investigate the prognostic significance of a fragmented QRS (fQRS) complex in a patient     who had undergone primary percutaneous coronary intervention (PCI).   "
250689|NCT01136850|"     The purpose of this study is to determine whether repeated courses of     sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic,     leads to lower rates of low birth weight deliveries (<2.5 kg) among Papua New Guinean women,     than the current standard treatment of SP and chloroquine.   "
250690|NCT01137500|"     Various haemodynamic changes are observed during laparoscopic surgery, relating to     insufflation of CO2 & patient position. Cardiac output calculations using oesophageal doppler     monitoring are based on the assumption that the aortic diameter is fixed. This study aims to     measure the aortic diameter at preset times during surgery using ultrasound to discover if     the diameter remains the same, and hence if the assumptions made by the oesophageal monitor     are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement     taken in patients electively having laparoscopic procedures at the Royal Surrey County     Hospital.   "
250693|NCT01137539|"     This is a pilot study to assess the feasibility and success of performing the TVT-Secur in     the office setting. Endpoints would be success, complications, and patient and physician     acceptance of the procedure. Success would be assessed by validated questionnaires.      This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure     done in the office under local anesthesia. They will be followed for a period of 3 years.   "
250694|NCT01137552|"     This is a first in human, open-label, sequential dose escalation and expansion study of AMG     780 in up to 62 subjects with advanced solid tumors. The dose escalation part of the study is     aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG     780. The dose expansion will consist of up to 20 subjects and the dose level of AMG 780 will     be dependent upon emerging safety and PK data from the dose escalation part of the study.   "
250695|NCT01137565|"     The purpose of this study is to study the safety and tolerability in adolescent and adult     subjects with intermittent or mild to moderate persistent asthma.   "
250696|NCT01137578|"     This protocol will serve as a pilot study to determine the validity and feasibility of     contrast enhanced magnetic resonance imaging (MRI) without and with contrast and/or     ultrasound (US) for detection of catheter related deep vein thrombosis (DVT) in children   "
250697|NCT01137591|"     The purpose of this study is to compare the efficacy of the an N-acetyl-p-aminophenol (APAP,     also known as acetaminophen) and N-acetylcysteine (NAC) combination versus an APAP-placebo     combination as an anti-pyretic agent.   "
250698|NCT01137604|"     An open-label phase 2, multicenter study in participants with recurrent malignant glioma.   "
250699|NCT01137617|"     The purpose of this study is to better understand how the Spinal Cord Stimulator works in     relieving chronic pain.      The investigators are asking subject to take part in this study because who are chronic pain     patients who already have a Spinal Cord Stimulator (SCS) in place.      The investigators hypothesize that chronic pain patients will have higher heat pain     threshold, heat pain tolerance and wind-up over the painful areas with the SCS on.      QST (Quantitative Sensory Testing, a heat/cold simulation test) might be an objective helpful     tool for prudent patient selection for an expensive and invasive procedure for future SCS     placement.   "
250700|NCT01137630|"     Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales)     disorder patterned on the sebum-rich areas of the scalp, face, and trunk.      The current treatment does not cure the disease permanently. Therefore it must be repeated     when the symptoms recur, or even prophylactically. Corticosteroids and antifungals are the     mainstay of therapy. Topical corticosteroids rapidly reduce the cutaneous signs of disease,     but are associated with a high frequency of relapse when treatment is stopped. They are     reserved for acute flare-ups only as they may precipitate recurrences and dependence. In     addition, chronic use of corticosteroids is associated with side-effects.      The scientific rationale for the use of K40 for treatment of SD was based on clinical     evidence that K40 improves erythema and desquamation with mild adverse reactions in a few     cases. The primary objective of the study was to evaluate the efficacy of K40 (K40a and K40b     combined) compared to placebo after 4 weeks treatment as measured by the sum of erythema and     desquamation scores at Week 4.   "
250701|NCT01137643|"     RATIONALE: Collecting and storing samples of tissue, blood, and body fluid from patients with     cancer to study in the laboratory may help the study of cancer in the future.      PURPOSE: This research study is collecting and storing blood and tissue samples from patients     being evaluated for hematologic cancer.   "
250702|NCT01137656|"     The purpose of this study is to explore the impact of aged blood on endothelial function by     measuring forearm blood flow during intra-arterial acetylcholine infusion in normal healthy     human volunteers after infusion of autologous blood stored for 5-10 days or 35-42 days.      Our hypothesis is that 1) the vasodilatory response to the infusion of acetylcholine will be     reduced in the 35-42 day group compared with the 5-10 day group, because of scavenging of the     NO released from the endothelium by the hemolytic process in the aged blood, 2) that the     infusion of aged stored blood will produce vasoconstriction, measured by reduced forearm     blood flow during infusion of the 35-42 day compared with the 5-10 day old blood, and that 3)     there will be increases in venous levels of cell free plasma hemoglobin, red cell     microparticles, red cell membrane damage, arginase levels and activity, decreased arginine     levels, markers of oxidative stress (carbamylated proteins and nitrated tyrosine residues),     and increases in plasma in vitro NO consumption during the infusion of 35-42 day old compared     to 5-10 day old blood.   "
250703|NCT01137669|"     The purpose of this study is to test the safety of a licensed zoster vaccine, ZOSTAVAX®     (Zoster Vaccine Live) in 40 subjects, age 18 years or older, with chronic kidney disease     (CKD) who are scheduled to receive a living donor kidney transplant. ZOSTAVAX® is not     licensed for use in immunosuppressed persons and in the United States for individuals less     than 50 years of age. Subjects will receive either ZOSTAVAX® vaccine or placebo (inactive     substance) no less than 4 weeks prior to their kidney transplant. Study procedures include:     physical exam, blood samples and documentation of daily temperatures and/or side effects in a     diary following vaccination. Participants may be involved in study related procedures for up     to 18 months.   "
250704|NCT01137682|"     This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus     octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.   "
250720|NCT01137890|"     This is a residential pilot trial to evaluate the pharmacodynamic interaction between     zonisamide and cocaine, with the goal of evaluating zonisamide's potential for the treatment     of cocaine dependence.   "
250763|NCT01138449|"     The study is a large randomized controlled trial to assess the efficacy and safety of     neonatal vitamin A supplementation administered to neonates once orally either on the day of     birth or in the next 2 days in improving infant survival in the first 6 months of life.   "
250721|NCT01137903|"     Hypothesis:Surgical treatment of osteomyelitis in diabetic foot is more effective that     medical treatment through antibiotherapy and leads wound healing in ulcers complicated with     bone infection.Material and Methods: Randomized clinical trials which include two groups of     patients (n=88), one receives medical treatment through antibiotherapy during 90 days and the     other group receive conservative surgical treatment and antibiotics during 7 days after     surgery. It will be studied differences between both groups in healing time, recidives,     present and relationship of adverse events and outflow of quality of life related health .   "
250705|NCT01137695|"     The hypothesis of the study is that those obese patients with type 2 diabetes mellitus who do     not respond to the FDA approved dose of 120 mcg of pramlintide (Symlin®) 3 times daily with     expected glucose control require higher than FDA approved dosage.      The primary objective of the study is to determine whether higher doses of pramlintide     (Symlin®) in patients with type 2 diabetes mellitus control glucose better than the FDA     approved dose of 120 mcg three times daily.      The secondary objectives include proving whether higher dose pramlintide (Symlin®) is more     efficacious in causing weight loss and reduction in waist circumference than standard dose     pramlintide (Symlin®),to determine whether blood levels of certain hormones correlate with     need for higher dose therapy,and to determine whether or not the rate of common adverse     effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg three times     daily.   "
250706|NCT01137708|"     This study is designed to assess whether co-administration of CP-690,550 and oral     contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers.   "
250707|NCT01137721|"     Sickle cell anemia (SCA) is a serious blood disease with blood vessel changes leading to     brain injury and stroke. Studies show about 11% of patients with SCA will develop obvious     stroke before age 20 years, with children less than 10 years of age especially vulnerable.     The main objective of the SCDMR4[State Of The Art Functional Imaging In Sickle Cell Disease]     trial is to compare the gray matter cerebral blood flow, measured by MRI,[magnetic resonance     imaging] ASL [Arterial Spin Labeling] perfusion before treatment begins and after the     appropriate hydroxyurea dosage is reached (~ one year). Other important objectives of the     SCDMR4 trial include describing the effect of hydroxyurea therapy and transfusion therapy on     the functional MRI response, diffusion tensor imaging of white matter, brain function, and     transcranial Doppler blood velocities.   "
250708|NCT01137734|"     Annuloplasty device for repair of mitral valve regurgitation with option to adjust device     post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional     annuloplasty ring, the Cardinal system offers the clinician the opportunity to make     adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce     the number of patients leaving the operating room with residual regurgitation after mitral     valve repair.   "
250709|NCT01137747|"     This study is to test escalating doses of carfilzomib in patients with relapsed acute myeloid     and acute lymphoblastic leukemia.   "
250710|NCT01137760|"     The purpose of this research study is to determine whether a functional fiber,     galactooligosaccharide, can help maintain immune strength and digestive health in     undergraduate students who are undergoing an academic stress (i.e., final exams). Subjects     will be asked to consume the fiber or placebo each day for eight weeks. Immune and     gastrointestinal health will be evaluated via daily questionnaires obtained from 420 students     and from the collection of fecal samples in a subgroup of students.   "
250711|NCT01137773|"     Brain injury patients who meet defined criteria will be assigned to intensive insulin     treatment (target blood glucose levels of 10-110 mg/dl) or conventional IV insulin treatment     (target glucose of 150-170 mg/dl). Follow up will occur at 3, 6 and 12 months. The primary     outcome measure will be neurological outcome at 12 months according to Karnofsky Performance     Scale (KPS). A general view of outcome will also be presented as favorable (good recovery+     moderate disability), unfavorable (severely disabled+ vegetative state), and dead.      Secondary outcome measures will be blood glucose levels and death.The investigators will also     record systemic complications like pulmonary emboli, pulmonary edema, myocardial infarction,     ventricular arrhythmias, and pneumonia.   "
250712|NCT01137786|"     This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated     contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled     must have normal eGFR. Statistical summaries will be presented to analyse the various     laboratory tests for the two groups.   "
250713|NCT01137799|"     This study in patients with stable schizophrenia will investigate the effect of JNJ-39393406     on Event Related Potentials (Auditory Evoked Potential [AEP] P50, AEP P300 and Mismatch     Negativity [MMN]) after single dose administration.   "
250714|NCT01137812|"     The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared     with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with     metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.   "
250715|NCT01137825|"     RATIONALE: Gathering information about older patients with cancer may help the study of     cancer in the future.      PURPOSE: This research study is gathering information from older patients with cancer into a     registry.   "
250716|NCT01137838|"     To compare the proportion of rheumatoid arthritis (RA) patients prescribed opioids,     benzodiazepines, and antidepressants before versus after starting each of the following     biologics: abatacept, infliximab, etanercept, adalimumab, utilizing an administrative claims     database.   "
250717|NCT01137851|"     The purpose of this study is to assess the impact of patient cost sharing on treatment     discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)   "
250718|NCT01137864|"     CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions     ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve     the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet     fully estimated using a randomized trial to compare the quality of care of patients who will     benefit of the intervention.      OBJECTIVES: To show using a randomized trial that patients hospitalized in emergency wards     with IDS advice will receive more appropriate antimicrobial therapy but less exposure to     antibiotics, as compared to patients who will not receive IDS advice.      METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of     prescriptions in two groups of patients admitted in emergency wards:      Control group: antibiotic prescriptions will be initiated and managed by the attending     physicians Intervention group: antibiotic prescriptions will be systematically evaluated by     the IDS and changed if judged necessary by the attending physicians, following IDS' advice.      STUDY PROCESS: The study will took place in the emergency wards of 4 university hospitals.     For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12     months.   "
250719|NCT01137877|"     The objective of this study is to evaluate the effect of two experimental milk-based infant     formulas on the growth and gastrointestinal (GI) tolerance of term infants.   "
250723|NCT01137929|"     No single host or pathogen trait identified by previous research can be correlated with all     cases of childhood acute pyelonephritis or APN (i.e., kidney/upper urinary tract infections)     and APN-associated renal scarring (the outcome with the highest morbidity), making it     difficult for physicians to determine which patients will be affected. Our proposal is to     comprehensively study the relationships between the clinical manifestations of urinary tract     infections (UTIs), the host risk factors and immune response, and the microbial species that     cause these conditions. The result of the study will be a clinical severity score to     personalize diagnostic and treatment strategies for infants with UTI, with the goal of     decreasing the morbidity of APN/renal scarring and improving patient outcomes.   "
250724|NCT01137942|"     The immune response to Helicobacter pylori (Hp) importantly determines the pathogenesis of     infection as well as the success of antibiotic eradication of the bacteria. The investigators     want to demonstrate the importance of cathepsin X (CTSX), a cysteine protease, for the Hp     eradication success. The diversity of the innate immune response to H. pylori antigens     leading to either successful eradication of the infection or maintenance of chronic     inflammation is connected to CTSX. The aim of this study is to determine whether H. pylori     suppresses the CTSX expression and cytokine secretion in macrophage cell line THP-1 in the     individuals that are not capable of eradicating the infection, opposite to H pylori in     patients with successful H pylori eradication . The investigators also investigate the     possibility whether strain-dependent differences in H. pylori lipopolysaccharide (LPS)     influence the CTSX expression and cytokine secretion.   "
250725|NCT01137955|"     Celiac disease is a condition in which the small intestine is damaged by gluten, the storage     protein of wheat and similar proteins in barley and rye. The disease can cause different     symptoms such as diarrhea, bloating, abdominal pain and weight loss. The majority of patients     respond to a gluten-free diet. However some patients (5-30%) have persistent symptoms and are     considered to be poor responders to the diet. Bacterial overgrowth in the small intestine     accounts for some of the refractory patients.      This study seeks to determine if antibiotic therapy with rifaximin relieves the symptoms of     patients who are poorly responsive to a gluten-free diet and whether this impacts their     breath test results.   "
250726|NCT01137968|"     The purpose of this is to evaluate the efficacy and safety of imetelstat (GRN163L) as     maintenance therapy for patients with advanced stage NSCLC who have not progressed after 4     cycles of platinum based therapy.      Participants will be randomized in a 2:1 ratio to imetelstat + standard of care versus     standard of care alone. Participants who received bevacizumab with their induction     chemotherapy will continue to receive bevacizumab on this study.   "
250727|NCT01137981|"     The APR began as the 'Zidovudine in pregnancy Registry' in January 1989 and became the     'Antiretroviral Pregnancy Registry' in January, 1993. The purpose of the APR is to detect any     major teratogenic effects involving any of the Registry drugs when administered to pregnant     HIV positive women. The Registry is intended to provide an early signal of teratogenicity     associated with prenatal use of the antiretroviral drugs. The Registry collects data on     prenatal exposures to antiretroviral drugs, potential confounding factors (such as maternal     age, disease status during pregnancy), and information about the outcome of the pregnancy.      The Registry is managed by INC Research. The scientific conduct and analysis of the Registry     data are overseen by an independent Advisory Committee consisting of members from the Centers     for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), the National     Institutes of Health (NIH), and the academic sector. Registry data are obtained from     participating providers who encompass physicians in private practice as well as hospitals and     community clinics.      The registry is co-sponsored and co-funded by 26 pharmaceutical companies that manufacture     drugs used in ART.      For an updated version of the registry, please see NCT00404989.   "
250728|NCT01137994|"     This is a Phase II, randomized, open-label, multi-center study evaluating the efficacy and     safety of lapatinib in combination with chemotherapy versus trastuzumab in combination with     chemotherapy in women with HER2-positive and p95HER2-positive metastatic breast cancer (MBC).     Eligible subjects will have newly diagnosed metastatic breast cancer (Stage IV) either as a     primary diagnosis or as a recurrence following treatment of curative intent; not have     received systemic or local treatment for MBC and have breast cancer that is positive for HER2     and p95HER2. The primary objective is to compare progression-free survival (PFS) of lapatinib     plus chemotherapy versus trastuzumab plus chemotherapy as first-line treatment in subjects     with MBC exhibiting concurrent HER2 overexpression (and/or gene amplification) and expression     of carboxy-terminal fragments of HER2 (p95HER2). The secondary objectives are to evaluate     overall survival, overall response rate, clinical benefit response rate and the safety as     well as tolerability of lapatinib plus chemotherapy and trastuzumab plus chemotherapy.   "
250729|NCT01138007|"     This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison     study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to     patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day for     8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total     score, and to evaluate the safety based on adverse events, clinical laboratory tests and     vital signs.   "
250730|NCT01138020|"     The purpose of this study is to investigate the efficacy of a structured rehabilitation     program on cognitive function and quality of life in individuals with blast-induced traumatic     brain injury (bTBI).   "
250808|NCT01139047|"     The purpose of this study is to compare the tolerability of MetroGel® 1% to Finacea® 15% in     subjects with healthy skin applied according to product labeling for three weeks.   "
250751|NCT01138293|"     Aims: During the last decades overweight/obesity has increased markedly. They are associated     with a high risk for diabetes and death. Effective intervention is mandatory. Following     participation in treatment programmes children/adolescents often fail to reach sufficient     long-term weight reduction. The present trial aims to integrate telemedical support in     therapy to improve long term outcome.      Methods: All children/adolescents with overweight/obesity were included (n=66,age 13.9±2.6     years, body mass index [BMI] 31.2±5.4kg/m², body mass index standard deviation score     [BMI-SDS] 2.41±0.6) admitted to our hospital 04-03/2009. To asses physical activity and     eating habits electronic health technology was used (Fraunhofer-Institute). The system     consists in a motion sensor integrated in a mobile phone(DiaTrace). The system analyses kind,     intensity and duration of physical activity and eating habits.   "
250731|NCT01138033|"     This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will     identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Following     identification of the MTD, enrollment into Parts 2, 3, 4 and 5 may be concurrent. Part 2 will     explore further the safety, PK, tolerability, and anti-tumor activity of GSK2256098 in     subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will     characterize the range of biologically effective doses by assessing pharmacodynamic (PD)     markers in hair, skin and tumor tissue at doses that will not go lower than 80 mg or above     the MTD dose levels tested during the Phase 1 dose escalation. Part 4 will explore further     the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed     glioblastoma multiforme (GBM). The primary objective of this study is to determine the     safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the     pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to     explore the anti-tumor activity of GSK2256098, and to explore relationships between     GSK2256098 PK, PD and clinical endpoints. Part 5 will investigate the time course, the extent     of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for     potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098     at Day 15 and later time points. The primary objective of this study is to determine the     safety, tolerability, and MTD of GSK2256098.   "
250732|NCT01138046|"     This is an open-label, non-randomized, multi-center study of lapatinib plus paclitaxel to     evaluate safety, tolerability and efficacy in Japanese patients with ErbB2 over expressing     advanced or metastatic breast cancer. Lapatinib 1500mg/day will be administered in     combination with paclitaxel 80mg/m2/week. Lapatinib and paclitaxel will be administered until     disease progression or withdrawal from the study due to unacceptable toxicity.      The study will proceed in two phases. The first phase (Phase I part) will lead to evaluate     safety and tolerability of lapatinib taken together with paclitaxel in the first 6 subjects.     Pharmacokinetic profile also will be evaluated as the secondary objects.      Then the study will move to the next treatment phase (Phase II part) to evaluate further     safety and clinical activity, if no major safety concerns are raised during Phase I part. The     primary objective of the study is to evaluate overall survival (OS), and the secondary     objectives are Objective tumour response rate (ORR), Duration of response, Time to response,     Clinical benefit and Progression-free survival (PFS) in 12 subjects.   "
250733|NCT01138059|"     This study will test the hypothesis whether patients with unclear-onset stroke (UnCLOS)     treated with thrombolysis could achieve a prespecified rate of good clinical outcome. The     secondary hypothesis is that the efficacy outcomes in UnCLOS group would be superior to those     in historical UnCLOS group from prospective stroke registries.   "
250734|NCT01138072|"     This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the     effect of repeated doses of GSK2248761 on the pharmacokinetics of simvastatin, atorvastatin,     and rosuvastatin in healthy adult subjects. In this study, approximately 14 subjects will     receive single doses of simvastatin, atorvastatin, and rosuvastatin on two occasions, once     alone and once following administration of repeated doses of GSK2248761. Safety evaluations     and serial PK samples will be collected during each treatment period. A follow-up visit will     occur 7-14 days after the last dose of study drug.   "
250735|NCT01138085|"     This study is a Phase 1 dose-escalation open-label study to determine the recommended Phase     II dose (RP2D) and regimen for the combination of the orally administered MEK inhibitor     GSK1120212 and the orally administered AKT kinase inhibitor GSK2141795. The study consists of     two parts. Part 1A will identify the maximum tolerated dose (MTD) using a Zone-Based,     modified 3 plus 3 dose escalation procedure. The starting dose (Zone 1, Cohort 1) will be     0.5mg GSK1120212 combined with 25mg GSK2141795. Dose escalation will continue based on     predefined parameters until a MTD is established. The initial regimen for dose escalation in     Part 1A will be continuous oral daily dosing. Once the continuous daily dosing MTD or RP2D     has been established in Part 1A, Part 1B will explore alternate dosing schedule(s) in which     the dosing schedule may be adjusted for either GSK1120212 or GSK2141795. Dose escalation will     proceed using a 3 plus 3 dose escalation procedure until an MTD or RP2D of that alternate     schedule is defined. Part 2 will explore further in specific tumor types the safety,     tolerability, clinical activity, pharmacokinetic (PK) and pharmacodynamic (PD) properties of     the combination of GSK1120212 and GSK2141795 at the recommended dose(s) and regimen(s)     identified in Part 1.   "
250736|NCT01138098|"     This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after     vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune     response to the challenge dose of Engerix™-B.   "
250737|NCT01138111|"     The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission     tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI)     progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.   "
250738|NCT01138124|"     High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there     has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by     spontaneous reports in the Adverse Events Reporting System or in the published literature. In     a published case-control screening study of the association of gabapentin with 55 cancers,     the only cancer that met the screening criteria for possibly increased cancer risk with     gabapentin exposure was renal (including renal pelvis) cancer. This association was judged to     be likely due to or substantially accentuated by confounding by cigarette smoking,     hypertension, and lifestyle (Cancer Causes Control 2009;20:1821-1835).      The primary objective of this study is to determine whether exposure to gabapentin is     associated with an increased risk of developing pancreatic cancer or renal cancer in the     United Kingdom (UK) General Practice Research Database (GPRD). Almost all members of the UK     population are registered with a General Practice, which centralizes the medical information     not only from the general practitioners themselves but also from specialist referrals and     hospital attendances. Over 487 General Practices contribute data to the GPRD.      The study cohort from which cases and controls are drawn is all subjects in the GPRD     1993-2008. Gabapentin was approved in the UK in May 1993. Entry into the study cohort begins     Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of     registration if later than Jan 1, 1993. Patients with a first diagnosis of the respective     cancer 1995-2008 are risk set matched with up to 10 controls within the same General Practice     for age at cohort entry (within two years), sex, and year of entry into the study cohort     (within one year). For cases, the index date is the date of first diagnosis of the respective     cancer. The index date for controls is set as the date at which the follow-up time from     cohort entry is the same as the case. The index date is chosen so as to give the control     equal follow-up time to that of the case for ascertainment of use of gabapentin. Cases and     controls will be required to have at least 2 years of follow-up in the study cohort before     their index date. Data on gabapentin prescriptions are obtained for cases and controls from     study cohort entry to the index date.      Crude and adjusted odds ratios and 95% confidence intervals (CI) will be produced from     conditional logistic regression models, with additional analyses evaluating for latency and     dose-response. For pancreatic cancer, covariates are smoking, body mass index, diabetes,     epilepsy, neuropathic pain, and chronic pancreatitis. For renal cancer, covariates are     smoking, body mass index, diabetes, hypertension, diuretic use, epilepsy, and neuropathic     pain.   "
250739|NCT01138137|"     RATIONAL FOR STUDYING IV NAC AS POTENTIAL CHEMOPROTECTANT:      Cisplatin has shown efficacy in the treatment of subjects with epithelial ovarian cancer.     Systemic toxicities associated with cisplatin include nephro, oto, and nerve toxicities. It     may be possible to reduce the toxicities of cisplatin by administering it in conjunction with     IV NAC. NAC may reduce cisplatin related nephro, oto, and nerve toxicities without     compromising the effectiveness of the chemotherapy against the ovarian cancer cells. It is     possible that this combination of drugs may in the future allow ovarian cancer patients to     receive the full series of IP cisplatin-paclitaxel chemotherapy, with fewer side effects and     improved survival.      It is hypothesized that the proposed treatment of stage III or IV epithelial ovarian cancer     with IP cisplatin and IV/IP paclitaxel in conjunction with IV NAC will limit the     neurotoxicity, nephrotoxicity and ototoxicity that is associated with cisplatin     administration.   "
250740|NCT01138150|"     The purpose of this study is to evaluate blood levels of several proteins that may be altered     in the inflammation associated with migraine headaches. These blood levels will be evaluated     in individuals during an acute migraine attack and compared to their levels when pain free.     The investigators study hypothesis is that the pro inflammatory proteins in the blood will be     greater than the levels of these proteins when evaluated during a pain free period.   "
250741|NCT01138163|"     The primary purpose of this research study is to see whether adding bavituximab (an     investigational drug) to the standard chemotherapy drug docetaxel, will improve the results     of the treatment for non-small-cell lung cancer.   "
250742|NCT01138176|"     A prospective randomized control trial to examine safety and effectiveness of whole body     cooling to a rectal temperature of 33.5 C using phase changing material in neonatal     encephalopathy. Effectiveness will be defined by examining the stability of rectal     temperature during cooling. Monitoring of vital signs, infection screen, blood counts,     coagulation screen, liver and renal function tests, cranial US and MR imaging will be     performed on recruited infants to evaluate safety of cooling. EEG will be performed on day 4     and hearing evaluation at discharge. Neurodevelopmental evaluation will be performed at 1     year of age.   "
250743|NCT01138189|"     The purpose of the study is to compare the results of LASIK surgery when using     wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser     treatment in patients with nearsightedness with and without astigmatism   "
250744|NCT01138202|"     To assess safety, efficacy and impact of Lopinavir/ritonavir 400/100mg bid or     Lopinavir/ritonavir 600/150mg bid in combination with rifampicin-containing anti-TB therapy.   "
250745|NCT01138215|"     To study about the immunogenicity, safety and efficacy of varicella-zoster virus vaccine in     HIV-infected children.   "
250746|NCT01138228|"     VueTek has developed a head mounted device that will improve the viewing of superficial,     subcutaneous vasculature, differentiating it with higher contrast from surrounding tissue.     Video of the vasculature is displayed to the user in a portable headset. The headset and     display combination facilitates both visualization in the display and an open field of view     directly to the subject's anatomy and practitioner's surroundings. The goal is to provide a     non-diagnostic, enhanced visual aide that is used alongside standard visual and tactile     methodology. The primary and secondary objectives of this validation are as follows:        1. Primary Objective:           To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous          vascular structures, when compared to the naked eye.        2. Secondary Objective:      To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular     structures over the naked eye.      Validation Ancillary Endpoints      1. To gather data to demonstrate that the VTS1000 is portable, affords conventional vascular     access methods, and provides flexibility, fit and balance during use.   "
250747|NCT01138241|"     To assess and validate equation eGFR in HIV-infected subjects and -uninfected Thai patients   "
250748|NCT01138254|"     Vascular access complications are the leading cause of morbidity in hemodialysis (HD)     patients, and are responsible for a significant percentage of hospitalization, with annual     costs approaching one billion dollars in the United States. Thrombosis is the most common     cause of vascular access failure, and usually develops from stenotic lesions in the venous     outflow tract. It has been reported that far infrared (FIR) therapy can improve access flow     and unassisted patency of AV fistula, however, the effect of FIR on cardiac function is     unknown.      The aims of this study are to evaluate (1) the change of access flow of AV fistula and the     effect of AV fistula on echocardiographic parameters and (2) the effect of FIR on access flow     of AVF and echocardiographic parameters and the serum levels of endothelial markers in     patients with end stage renal disease (ESRD) during the first 6 months after the creation of     AV fistula.   "
250749|NCT01138267|"     Objectives:        -  To evaluate the impact of genetic polymorphism on ARV drug levels        -  To evaluate the effect of genetic polymorphism/drug levels on long term immunologic and          virologic response        -  To correlate the genetic polymorphism/drug levels on antiretroviral toxicities      The long-term objective of this research plan is to characterize impact of pharmacogenomics     to HIV drug concentration, toxicities, and response to antiretroviral therapy among     HIV-infected adults. A comprehensive understanding of the impact of pharmacogenomics to HIV     infection and HIV medication will lead to the development of appropriate intervention such as     dose reduction strategies in patients with particular gene(s) correlated with higher drug     levels. The dose reduction strategy will decrease long term drug toxicity and cost saving for     Thais and Asian Ethnicities.   "
250750|NCT01138280|"     Hemodialysis (HD) may lead to increase inflammatory response through a number of mechanisms.     HD-related inflammation is mainly due to underlying kidney disease, coexisting comorbidities,     uremia per se, dialyzer membrane biocompatibility and contaminated dialysis fluid.     Accordingly, HD patients are chronically exposed to microinflammation as a result of     blood-membrane interaction and dialysis fluid contamination. Among these factors, biofilm     formation and contaminated dialysis fluid are closely related to enhanced immune activation     in HD patients. Furthermore, only dialysis fluid quality is controllable and preventable.     Therefore, to reduce the cardiovascular (CV) events and improve the outcome, it prompts us to     conduct a prospective randomized controlled study to explore whether heat disinfection link     in HD water treatment system can effectively prevent biofilm formation, to ensure the     dialysis fluid purity, and subsequently to improve the patient outcome, in terms of CV events     and mortality.   "
250753|NCT01138319|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in patients with acute myeloid leukemia.   "
250754|NCT01138332|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in tissue samples from young patients     with acute myeloid leukemia.   "
250755|NCT01138345|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer. It may also help doctors     understand how well patients respond to treatment.      PURPOSE: This research study is studying biomarkers in blood samples from older women with     stage I, stage II, or stage III breast cancer who have finished primary therapy or breast     cancer survivors.   "
250756|NCT01138358|"     RATIONALE: Gathering information about experiences of episodic breathlessness in patients     with advanced disease may help doctors learn more about the disease.      PURPOSE: This clinical trial is studying experiences of episodic breathlessness in patients     with lung cancer or other advanced disease.   "
250757|NCT01138371|"     The primary objective of this study is to measure how LDL apheresis affects levels of     inflammatory and cholesterol markers in human beings. The investigators will address this     question by drawing pre- and post-LDL apheresis blood from patients who are undergoing this     procedure. A secondary objective of this study is to learn how specific inflammatory markers     behave in our blood in terms of time to rebound back to normal levels. The investigators will     address this question by drawing post-LDL apheresis blood at predetermined time intervals.   "
250758|NCT01138384|"     This research is being done because it is not yet known what dose of foretinib in combination     with lapatinib can be given safely to patients with breast cancer, nor what type and severity     of side effects will result from the combination of the two treatments. This research is also     being done because it is not clear if the addition of the new drug foretinib to treatment     with lapatinib can offer better results and longer survival than treatment with lapatinib     alone.   "
250759|NCT01138397|"     The aim of this study is to evaluate the new formulation of the influenza vaccine for the     2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the     corresponding population and to check its compliance with the Committee for Proprietary     Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96      Objectives:        -  To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the          intradermal (ID) influenza vaccine NH 2010-2011 formulation with the requirements of the          CPMP NfG CPMP/BWP/214/96.        -  To describe the safety of the corresponding strength of the ID influenza vaccine, NH          2010-2011 formulation.   "
250760|NCT01138410|"     The study is an investigation of a novel immunotherapy, SCIB1, for the treatment of melanoma.     SCIB1 is a solution of plasmid DNA molecules which will express a modified antibody in human     cells. The antibody modifications are designed to stimulate the patient's immune T cells to     have a strong and specific reaction against melanoma cells which should then be eliminated.     SCIB1 is injected into muscle using a device which simultaneously delivers an electrical     impulse to enhance the transfer of SCIB1 into muscle cells. The trial will assess the safety     and tolerability of SCIB1, the safety and performance of the injection device and the     immunological effects of SCIB1. This is the first study of SCIB1 in humans and the trial has     two parts, in the first part the dose will be escalated to determine a safe and tolerable     level up to a maximum of 8 mg per dose. In the second part patients will receive the dose     determined in the first part. Patients will have stage III or IV melanoma, be HLA type A2 and     have a life expectancy of at least three months. All patients will receive 5 injections of     SCIB1 over 5.5 months. At the discretion of the investigator, patients may continue to     receive SCIB1 at 3-6 month intervals for 5 years. The study will be conducted at major cancer     centres in the UK only and is expected to last for seven years. Patients will be followed up     for five years after they have completed the trial.   "
250761|NCT01138423|"     High blood pressure (hypertension) is an important cause of myocardial infarction and stroke.     High blood pressure often occurs in people who are overweight. These people frequently also     have abnormal fat and sugar metabolism. The combination of these problems is called the     'metabolic syndrome'.      People with hypertension and obesity currently receive the same drug therapy as people with     hypertension, but without obesity. Different classes of drugs are thought to be equally     effective in lowering blood pressure.      Next to lowering blood pressure, hypertension treatment can have additional effects, like     changes in blood vessel function (the ability to dilate and constrict) or changes is the     metabolism of sugar and fat. Particularly in patients with the metabolic syndrome, these     additional effects are thought to be of great importance, because they can influence the risk     for cardiovascular diseases.      The blood pressure lowering mechanism differs between classes of blood pressure lowering     medication. The purpose of this study is to compare the effects of three types of blood     pressure lowering medication belonging to different classes. The main outcomes of interest     will be blood vessel function (the ability to dilate and constrict) and blood pressure.     Moreover, the effect of treatment on additional outcomes, like metabolism of sugar and fat,     will be studied.   "
250764|NCT01138462|"     The purpose of this study is to determine the better approach between the currently procedure     (i.e. standards precautions) and a reinforced strategy to control MRSA transmission in the     institutionalized population of nursing homes in Canton of Vaud, Switzerland.   "
250765|NCT01138475|"     Evaluate the efficacy of paricalcitol, cholecalciferol, and placebo in the reduction of     parathyroid hormone in patients after Roux-en-Y gastric bypass surgery (RYGB). Assess     changes, if any, in measures of self-assessed well-being attributable to paricalcitol after     RYGB. Evaluate the rates of hypercalcemia, kidney stones, gastrointestinal side effects, and     other organ system adverse effects of paricalcitol, cholecalciferol, and placebo in patients     after RYGB   "
250766|NCT01138488|"     This trial was conducted in Europe. The aim of this study was to investigate the total     exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult     subjects with type 1 diabetes.   "
250767|NCT01138501|"     This trial is conducted in Asia, Europe, and North and South America. The aim of this     clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant     factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.   "
250768|NCT01138514|"     The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel     Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical     Gel (Clindamycin- Benzoyl Peroxide Gel).   "
250769|NCT01138527|"     The primary objective of this prospective multi-centre study is to prove the diagnostic     accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution T2-weighted     MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other prostate     tissue. The gold standard for distinguishing the tissue types is the analysis of whole-mount     sections of the resected prostate by a genitourinary histopathologist.   "
250770|NCT01138540|"     This study is planned to compare, in patients sedated, intubated and mechanically ventilated,     the efficacy and safety of the Lateral Trendelenburg position in comparison to the     Semirecumbent Position to prevent incidence of ventilator-associated pneumonia (VAP).   "
250771|NCT01138553|"     The primary objective of this study is to identify the group of women with early stage breast     cancer most likely to benefit from treatment with the selective progesterone receptor     modulator (SPRM) mifepristone. This will be done by treating women briefly prior to planned     surgery and examining the decrease in growth rate (measured by Ki-67 immunohistochemistry) in     tumor samples taken before and after exposure to mifepristone.   "
250772|NCT01138566|"     The purposes of this study are:        1. To estimate the prevalence of extended spectrum β-lactamase (ESBL) and/or AmpC among          Enterobacteriaceae which cause community-onset urinary tract infections (UTIs)        2. To collect the background, risk factors and clinical outcome of patients with          community-acquired uropathogenic condition related to Enterobacteriaceae (both ESBL,          AmpC- and non ESBL and/or AmpC producing) after receive different antibiotic regimens.        3. To develop a scoring system to early identify patients at risk of being infected with          ESBL- and/or AmpC-producing Enterobacteriaceae by comparing the risk factors for          community-onset UTIs caused by ESBL- and/or AmpC-positive against non ESBL -and/or AmpC          Enterobacteriaceae        4. To demonstrate the efficacy and safety of ertapenem for the empiric treatment of          community-onset UTIs in patients at risk for ESBL- and/or AmpC-producing organism.      The study hypothesis (i) Patients infected with community-acquired uropathogenic ESBL- and/or     AmpC-producing Enterobacteriaceae who receive regimens other than carbapenems have a worse     outcome.      (ii) There are certain risk factors predicting the acquisition of community-onset UTIs caused     by ESBL- and/or AmpC-producing Enterobacteriaceae.      (iii) The use of ertapenem is an effective and safe empirical therapy compared with other     agents for community-onset UTIs caused by ESBL- and/or AmpC-producing Enterobacteriaceae.   "
250773|NCT01138579|"     This study is an investigator driven, open-label, non-randomized, uncontrolled, dose     escalating Phase I/II study evaluating the safety and preliminary efficacy of the     trifunctional bispecific antibody FBTA05 in combination with donor lymphocyte infusions (DLI)     for treatment of relapsed or refractory disease in CD20 positive either low- or high-grade     non-Hodgkin´s lymphoma after allogeneic transplantation   "
250774|NCT01138592|"     Primary Objective: Evaluation of the utility of real-time, scope-to-scope communication     between commercially-available 3M Littmann Electronic Model 3200 Electronic stethoscopes over     a dedicated intranet system for the assessment of patients at remote (satellite) clinic     locations by centrally-located (hub) medical providers.      Secondary Objective: Comparison of the accuracy of patient assessment between the remotely     located, mid-level presenter with the centrally-located physician or nurse practitioner     provider.   "
250775|NCT01138605|"     The primary objective of this study is to continue to provide Darunavir (DRV) to pediatric     patients who previously received DRV in any of three pediatric clinical studies sponsored by     Tibotec Pharmaceuticals and continue to benefit from using it, in countries where DRV is not     yet commercially available for the pediatric patient, is not reimbursed or cannot be accessed     through another source (like access program or government program).   "
250776|NCT01138618|"     Clozapine remain the drug of choice for treatment resistant schizophrenia and up to 60% of     patients not responding to other antipsychotics will respond to clozapine. However, the use     of clozapine is restricted due to the risk of agranulocytosis and consequently the need for     mandatory hematological monitoring. CHEMPAQ XBC is a point-of-care device that can be used in     patients home and analyze WBC and granulocytes by a single capillary blood drop. This study     aims to investigate whether this new procedure increases the acceptability of clozapine   "
250777|NCT01138631|"     In order to improve success rate by assisted reproductive techniques new techniques are being     developed for selection of the embryo with best chance of implantation, establishement of     pregnancy and subsequent delivery.The present study is based upon the hypothesis that     time-lapse (frequent imaging) may give information about important steps in embryonic     development, which could help to optimize selection of embryo(s) for treatment in IVF. The     present study evaluates the outcome of conventional embryo culture with culture in a     specially developed incubator equipped with a time-lapse system (Embryoscope).      Embryos from 50 IVF cycles (400 embryos) will be randomised to either conventional incubation     or to culture in the Embryoscope. Embryos will be cultured for five days to the blastocyst     stage. The primary endpoint is fraction of embryos developed to the four cell stage.   "
250778|NCT01138644|"     It is our hypotheses that 1) readily available Emergency Department data can be utilized in     an Atrial Fibrillation clinical prediction rule to identify those patients at low or high     risk for adverse outcomes; 2) Assigned risk can be utilized to drive physician     decision-making by identifying patients who do not require hospital admission (low risk) and     patients needing hospitalization (high risk); and 3) a facile version of the AFPR will be     easily incorporated into standard Emergency Department patient management systems and assist     physicians with risk stratification of patients presenting with Atrial Fibrillation.   "
250779|NCT01138657|"     A study comparing the safety and efficacy of adalimumab compared with placebo in patients     with active uveitis.   "
250780|NCT01138670|"     This study examines possible risk factors with regard to complications following pacemaker or     implantable defibrillator cardioverter (ICD) implantation.   "
250781|NCT01138683|"     The CRUF trial is a prospective randomized monocentric trial comparing different impact of     diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic     filling pressures, neurohormonal activation and biomarkers of Acute Kidney Injury (AKI).   "
250782|NCT01138696|"     About 20 years ago synthetic ligaments were used in orthopaedics / traumatology for the     repairing and replacement of injuries of the anterior cruciate ligament. After less than 10     years it appeared that a relatively important number of patients showed complications on the     basis of synovitis. The situation of another group of patients on the other hand evolved     favourably without complications. The study to focuses on this group of patients and attempts     to determine how the replacement without problems ab initio, evolved in the time.      It concerns a group of 57 patients who received an implantation in the UZ Ghent between     November 85 and October 87 with the Stryker Dacron ligament and a group of 33 patients who     received the Trevira ligament in the ASZ Aalst. The clinical result will be stipulated by     means of standardized questionnaires and a clinical examination. The radiological result will     be determined by the degree of integrity of the ligament that was implanted at the time. In     this way the study could give an idea about the degree in which the technical success of the     intervention correlates with the clinical success 20 years later.   "
250783|NCT01138709|"     The primary objective of this phase II clinical trial is to assess the safety of the Vitala™     device during 12 hours of daily wear with convex products.   "
250784|NCT01138722|"     Surgical resection with mediastinal lymph node sampling is currently the therapy of choice     for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or     unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This     has shown to result in a long term local disease control rate and a high cancer specific     survival.      The current trial addresses the relationship between blood and tissue biomarkers, bio-imaging     and pathology in patients with early stage NSCLC treated with hypofractionated radiation     therapy and surgery.   "
250785|NCT01138735|"     The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and     benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to     11 years of age with acne vulgaris.   "
250786|NCT01138748|"     Surgical resection with mediastinal lymph node sampling is currently the therapy of choice     for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or     unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This     has shown to result in a long term local disease control rate and a high cancer specific     survival.      The current trial addresses the issue if progression free survival (PFS) in patients treated     with radiotherapy can be predicted by a multi-variate model derived from a composite of     bio-imaging and biomarkers   "
250787|NCT01138761|"     The purpose of this study is to determine the effectiveness of additional nursing instruction     for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the University     of Missouri Dermatology clinic.   "
250788|NCT01138774|"     The aim of the study is to analyze the effects of Lipoic acid and/or EPA supplementation on     weight loss, lipid profile, insulin resistance, oxidative and inflammation parameters,     metabolomic profile as well as on adipose tissue gene profile in healthy overweight/obese     subjects following an energy-restricted diet.   "
250789|NCT01138787|"     Rationale: Consuming Plant Sterols (PS) fortified foods is widely accepted as easy to apply,     life-style change to combat modestly elevated plasma cholesterol concentrations. PS are     typically formulated as PS fatty acid ester (PSE) from margarines. In this study, PS will be     formulated in a new innovative type spread. To confirm that the new spread results in a     comparable cholesterol absorption inhibition as the reference product a dual isotope     cholesterol study is planned, prior to any larger efficacy study.      Primary objective: Cholesterol absorption inhibition (%) calculated from plasma concentration     vs. time curves from labeled cholesterol, for the PS or PSE containing products, compared to     a control product without PS or PSE.      Secondary objectives: PK parameters for cholesterol as derived from the plasma concentration     vs. time curves.      Study design: Acute, single dose, double-blind, randomized, cross-over. Study population: 18     healthy, non-obese men (BMI 20-27 kg∙m-2, age range 20 - 65 yr) Test products: PS (2250 mg)     formulated in innovatively processed spread (30 g); PSE (2250 mg PS) reference product (30     g); Control product without PS or PSE (30 g) Intervention: Three study periods during which a     single dose of either Test, Reference or Control (regular light spread) spreads will be     consumed together with standard breakfast. At each study period, 50 mg of D7-cholesterol is     added to the meal and 30 mg of 13C-cholesterol is injected to measure cholesterol absorption.     Before and four times after consumption of each spread, blood samples will be taken at 24 h     intervals up to 7 days.      Key parameters: Enrichments of labeled cholesterol isotopes as determined by GCMS and IRMS.     Fractional absorption is determined by the ratio of the two isotopes in plasma cholesterol     after 7 days.   "
250809|NCT01139060|"     The purpose is to test the effectiveness of an organized care program for chronic or     recurrent depression. Using a two-arm design, the investigators will randomly assign 300     participants with chronic or recurrent depression to one of two conditions: continued usual     care (UC); or an 18-month organized treatment program focused on outreach and engagement,     including a weekly group self-management training program, monthly visits with a     psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer     support specialist. All intervention components are intended as adjuncts to any existing     depression treatment (usually antidepressant medication) provided by participants' regular     providers.   "
250790|NCT01138800|"     Interstitial cystitis (IC) is a chronic disorder with significant symptoms of urinary     urgency, frequency and pelvic pain. IC is more prevalent in women than men. Similar to other     chronic pain syndromes such such as irritable bowel syndrome (IBS) and fibromyalgia, the     cause of IC is not fully understood. Two subtypes of IC have been identified: classic IC     (ulcerative IC) where visible ulcers exist in the bladder and non ulcerative IC, where     bladder abnormalities are not apparent but significant bladder-related symptoms exist. We     hypothesize that ulcerative IC is a disease of the bladder whereas non ulcerative IC is a     more generalized and centrally-mediated chronic pain syndrome similar to IBS and     fibromyalgia. To test this hypothesis, we will compare the presence of pain     conditions/symptoms in ulcerative vs. non ulcerative IC women vs. community dwelling women     (controls) without an IC diagnosis.   "
250791|NCT01138813|"     This study will evaluate the test-retest repeatability of lactate and other metabolites     measured by single voxel magnetic resonance spectroscopy (MRS) and multi-voxel magnetic     resonance spectroscopic imaging experiments (MRSI) in tumor tissue in patients     radiographically diagnosed with glioma.      These measurements will test whether the concentration of lactate in tumor will be higher     than the concentration of lactate in normal tissue of the same patient.   "
250792|NCT01138826|"     This study is being performed to determine the bioavailability, or extent of absorption into     the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to     the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.   "
250793|NCT01138839|"     The purpose of this study is to determine the efficacy of dexamethasone for treatment of     HELLP I (hemolysis, elevated liver enzymes and low platelet count) syndrome.   "
250794|NCT01138852|"     The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of     cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been     assessed.      Women scheduled for cesarean delivery were randomized to receive a single dose of either 3g     of ampicillin-sulbactam or 1.5g of cefuroxime intravenously, after umbilical cord clamping.     An evaluation for development of postoperative infections and risk factor analysis was     performed.   "
250795|NCT01138865|"     CPAP, the standard treatment for Obstructive sleep apnea syndrome (OSAS) that reduces sleep     fragmentations and neurocognitive deficit in OSAS may also have a key role in reduction of     cardiovascular, mortality risks in the same patients.   "
250796|NCT01138878|"     Surveillance data suggests that approximately one third of the 82 000 HIV infected adults in     the UK remain undiagnosed - that is, they are living with the infection but do not know this.     The majority of HIV testing in the UK to date has taken place in sexual health clinics and in     antenatal care. Published National guidelines advocate routine HIV testing of 16-65 year olds     in more general healthcare settings in parts of the country with relatively high rates of HIV     (more than 2 per thousand individuals diagnosed locally). The HINTS Study investigates the     utility, feasibility and acceptability, to patients and staff, of offering routine HIV     testing in four general medical settings, all set in areas of high HIV prevalence. The     settings comprise: Primary Care, Outpatients, an Acute Care Unit and an Emergency Department.   "
250797|NCT01138891|"     Objective. Capsular contracture is a frequent complication after breast implantation with     unclear etiology.      Summary Background Data: Microorganisms may trigger chronic periimplant inflammation with     subsequent capsular fibrosis.      Study Hypothesis: The investigators hypothesize that with sonication adherent microorganisms     can be detected on removed implants .      Methods: In a prospective multicentre study all breast implants explanted are collected to be     analyzed by sonication. The resulting culture results are correlated with patient, surgical     and implant characteristics.   "
250798|NCT01138904|"     FOLFOX* followed by FOLFIRI** or reverse sequence treatment regimen have been used as a     standard treatment modality in metastatic colorectal cancer.Oxaliplatin and Irinotecan were     used for advanced gastric cancer also. The investigators study was designed to evaluate the     safety and efficacy of FOLFOX followed by FOLFIRI or reverse sequence treatment regimen as a     first-line and second line therapy for patients with relapsed or metastatic gastric cancer     similar with colorectal cancer.      *FOLFOX: oxaliplatin followed by leucovorin before bolus 5-FU followed by continuous infusion     5-FU      **FOLFIRI: irinotecan followed by leucovorin before bolus 5-FU followed by continuous     infusion 5-FU   "
250799|NCT01138930|"     Berberine has showed effective in lowering blood sugar levels in db/db mice and     anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal     features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this     study is to examine the effect of Berberine metabolic and hormonal parameters and insulin     resistance in obese patients with PCOS.   "
250800|NCT01138943|"     The aim of the present study was to compare antiplaque effectiveness of two commercial     mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine     non-alcohol base with 0.1% of Formaldehyde (CLX-F).   "
250801|NCT01138956|"     This study is designed to evaluate the immune and therapeutic responses of visceral     leishmaniasis patients using N-acetylcysteine (NAC) as an adjuvant therapy to pentavalent     antimony.   "
250802|NCT01138969|"     Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.   "
250803|NCT01138982|"     This study aims to investigate the effectiveness of a one-to-one, adult-to-youth primary     preventive mentoring program in Sweden. Outcome domains and criteria for inclusion and     exclusion of study participants are elaborated in collaboration with the providing NGO, and     the program is given as customary.   "
250804|NCT01138995|"     The objective of this study is to determine the effectiveness of the NESS L300 (L300) in     improving gait parameters, function, and quality of life among stroke subjects (greater than     or equal to 3 months post stroke)with drop foot.   "
250805|NCT01139008|"     The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1%     to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product     labeling for three weeks.   "
250806|NCT01139021|"     One year antibody persistence after the fourth dose boost or two catch-up doses administered     starting from 12 months of age and to evaluate the response to a a third dose boost or two     catch-up dose starting at 24 months of age.   "
250807|NCT01139034|"     The purpose of this study is to investigate the effects of the self-designed surface     functional electrical stimulator on shoulder joint subluxation for stroke patients   "
250810|NCT01139073|"     The B/B Checker, a new portable device for detecting odorous compounds in oral, exhaled, and     nasal air, is now available. As a single unit, this device is capable of assessing several     kinds of gases mixed with volatile sulfur compounds (VSCs) in addition to other odorous     gasses. The purpose of the present study was to evaluate the effectiveness of the B/B Checker     for detecting the malodor level of oral, exhaled, and nasal air.   "
250952|NCT01140568|"     The purpose of this study is to determine the survival, disease response, and side effects of     Tasigna® (nilotinib) in patients who have malignant gliomas and are positive for Platelet     Derived Growth Factor Receptor (PDGFR) amplification. This study is designed to test the     hypothesis that patients with malignant gliomas with PDGFR amplification are sensitive to     PDGFR kinase inhibitors.   "
250811|NCT01139086|"     Shortness of breath, fatigue, and exercise intolerance are clinical symptoms of chronic heart     failure (CHF). Recent studies suggested that peripheral impairment was the major cause of     clinical symptoms, and mechanism may be related to neuroendocrine impairment and vascular     smooth muscle dysfunction. It results in increased peripheral resistance that may influence     limb blood flow, muscle fitness and activities of daily.The purposes of this study are        1. to compare muscular strength, endurance, and perfusion of quadriceps between CHF          patients and healthy controls by isokinetic test and near-infrared spectroscopy (NIRS)          and difference in activities of daily living        2. to compare endothelium function between CHF patients and healthy control subjects        3. the relationship between endothelium function, muscular strength, endurance, perfusion,          and metabolism of quadriceps.   "
250812|NCT01139099|"     Although the patients with schizophrenia can be treated with new generation of antipsychotics     medication, additional approaches are necessary to improve schizophrenics' cognitive     functions, interpersonal relationships as well as social adjustment. When some of patients     return to community, they expose to practical pressure that contribute to worsen and relapse     of disease. That further damages patient's cognitive functions. Integrated Psychological     Therapy(IPT) on treating schizophrenia has dramatic improvement in recent years; it has     formed structured treatment gradually on relieving illusion, hallucination as well as     negative symptoms. This study aims at conducting 12-week structured IPT group therapy. The     intended subjects are patients, met with DSM-Ⅳ-TR diagnosis of schizophrenia, from community,     outpatient and inpatient service. The overall treatments are designed to provide 1-2 hours     weekly group therapy which focuses on relieving illusions, hallucination, and negative     symptoms. Patients' cognitive functions, ability of emotional adjustment and interpersonal     relationship would be evaluated in pre-test and post-test to indicate whether the significant     difference exists. There is a controlled group, in which patients who still receive treatment     as usual (TAU). The study also compares the evaluation results between IPT group and TAU     group, hoping to develop the therapeutic framework for Taiwan people with schizophrenia.   "
250813|NCT01139112|"     This is a retrospective descriptive study on the clinical and microbiological features of     Klebsiella Pneumoniae Necrotizing Fasciitis.   "
250814|NCT01139125|"     The purpose of this study is to determine the tolerability of the medication cysteamine     bitartrate on schizophrenia patients and to evaluate the effect of the medication on the     symptoms of schizophrenia.   "
250815|NCT01139138|"     This study will assess the safety of panitumumab, irinotecan and everolimus when given in     combination to treat advanced colorectal cancer   "
250816|NCT01139151|"     The goal of this clinical research study is to find the highest tolerable dose of     4'-thio-araC (thiarabine) that can be given to patients with advanced blood cancer. The     safety of this drug will also be studied and 2 different dose schedules will be tested.   "
250817|NCT01139164|"     This is study is for patients that have been diagnosed with high-risk hematological     malignancies. The main purpose of this study is to confirm previously published results of     stem cell transplantation with reduced intensity pre-transplant conditioning. Patients will     be assigned to 1 of 3 regimens depending on the patient's diagnosis. Participants will be     followed by the transplant team for the remainder of the patient's life. Patient's will visit     MUSC daily, then visits will be reduced to frequent visits for up to 6 months. After 6     months, the visits will be reduced more depending on the patient's condition.   "
250818|NCT01139177|"     The primary objective of this study is to evaluate the safety and performance of the SAMBA     Stent and Delivery System in the treatment of femoropopliteal lesions.   "
250819|NCT01139190|"     The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of     PL3100 versus Naproxen in normal healthy volunteers.   "
250820|NCT01139203|"     Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and     adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune     globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver     transplantation patients with Hepatitis B Virus (HBV) related diseases.   "
250821|NCT01139216|"     The purpose of this study is to assess the dose-related effects of TU-100, a botanical agent     that modulates gastrointestinal nerves, on rectal compliance, rectal sensation thresholds and     small bowel and colonic transit in female patients with functional constipation as compared     to placebo.   "
250822|NCT01139229|"     The investigators improved the hybrid everted esophagogastrostomy and expected to prevent the     incidence of anastomotic stricture. The purpose of this study is to determine the clinical     value of this kind of operation type, and analyzes the clinicopathological factors causing     the postoperative complications.   "
250823|NCT01139242|"     This is an intervention study to increase colorectal cancer screening and physical activity     in members of African-American churches who are 50 years old and older. The control arm     receives the Body & Soul program, a program to increase fruit and vegetable intake. The     investigators hypothesize that those receiving the intervention, which includes four tailored     newsletters and peer counseling, will be more likely to be screened if not up-to-date, and     more likely to increase physical activity if screening was up-to-date at baseline, than     controls.   "
250875|NCT01139931|"     RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the     laboratory may help doctors learn about changes that occur in DNA and identify biomarkers     related to cancer.      PURPOSE: This research study is studying biomarker changes in samples from young patients     with acute myeloid leukemia.   "
250876|NCT01139944|"     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in tissue and blood samples from patients     with early-stage non-small cell lung cancer.   "
250899|NCT01133821|"     This proposed study is designed to compare the efficacy of interpersonal and social rhythm     therapy (IPSRT) alone to IPSRT plus medication as an acute treatment for bipolar II     depression. The investigators propose to conduct a randomized, controlled, trial comparing     the effects of IPSRT plus pill placebo to IPSRT plus quetiapine on depressive symptoms in     individuals suffering from Bipolar II depression. The investigators will also examine the     impact of treatment on psychosocial function.   "
250824|NCT01139255|"     Overweight and obesity play a role in both cancer incidence and survival rates. Many people     have found attending weight loss support groups to be time-intensive. Past research has shown     electronic media, particularly the Web, to be effective in producing weight loss. The Web,     however, lacks portability, which prevents people from accessing the information when it is     convenient for them. Providing weight loss information via podcasting (audio files that may     be listened to on portable audio players) may allow people to receive weight loss tips     anywhere. A previous research study showed that podcasts emphasizing healthy eating and     exercise can help people lose weight. This study was short-term and did not include     additional social support. The purpose of this research project is to assess the     effectiveness of a weight loss intervention delivered through podcasts as compared to the     same podcast with added mobile media such as self-monitoring software (such as a pedometer)     and support delivered via a social networking site. For this research study, the     investigators will conduct a 6-month study in 104 overweight adults to determine if a podcast     plus mobile media support leads to greater weight loss than a podcast alone.   "
250825|NCT01139268|"     Infertility affects an increasing number of couples. For many, the choice of treatment is in     vitro fertilization (IVF) . Currently, there are no markers fully predictive of developmental     competence of IVF embryos. Present embryo selection is based on morphology assessment, which     produces implantation rates in the range of 20%-30 %. The overall purpose of the present     study is to investigate methods for selection of the best embryo. We aim to examine the     relationship between pregnancy outcome and the transcriptional profile of selected genes,     cleavage kinetics (time-lapse), and metabolic profile. We hypothesise that the quality of the     embryo is reflected by the transcription of selected genes, the cleavage kinetics, and the     metabolic profile. If so, these parameters can predict the success or failure of a pregnancy.     Furthermore, the interrelationship - if any - between these parameters will be evaluated.      A secondary aim is to evaluate the effect of blastomere biopsy using time-lapse and metabolic     analysis   "
250826|NCT01139281|"     The proposal of this study was to evaluate in human beings, using distortion product     otoacoustic emission (DPOAE) test, the action of ginkgo biloba extract (GBE761)as a possible     ear protective against cisplatin (CDDP) induced hearing loss.   "
250827|NCT01139294|"     The purpose of this study is to non-invasively study the reflective changes in cardiac output     as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric     patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and     electrolytes compared to intravenous methods.   "
250828|NCT01139307|"     RATIONALE: Studying samples of blood or tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This research study is studying biomarkers in samples from patients with Down     syndrome and acute megakaryoblastic leukemia.   "
250829|NCT01139320|"     RATIONALE: Studying samples of DNA from patients receiving gemtuzumab ozogamicin may help     doctors learn more about the effects of gemtuzumab ozogamicin on cells. It may also help     doctors understand how well patients respond to treatment.      PURPOSE: This research study is studying biomarkers in DNA samples from younger patients with     newly diagnosed with acute myeloid leukemia receiving gemtuzumab ozogamicin.   "
250830|NCT01139333|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This research study is studying blood and tumor tissue samples from young patients     with acute myeloid leukemia.   "
250831|NCT01139346|"     This study is a Phase I, dose escalation study of oral darinaparsin for the treatment of     advanced solid tumors. Eligible patients could have received any amount of previous therapy.   "
250832|NCT01139359|"     This study is a Phase I trial of Darinaparsin in combination with CHOP for the treatment of     lymphoma. Eligible patients will not have had any previous anti-cancer treatment and will be     eligible to receive CHOP alone.   "
250833|NCT01139372|"     The purpose of this study is to describe the subjective assessments of an investigational     lubricant eye drop.   "
250834|NCT01139385|"     The aim of this study was to compare between the safety and efficacy of the harmonic shears     and the commonly used clip technique in achieving safe closure and division of the cystic     duct in the laparoscopic cholecystectomy in day surgery setting   "
250835|NCT01139398|"     The purpose of this study is to validate the effectiveness of food supplement Limicol on     reducing LDL-cholesterol in moderate hypercholesterolemic volunteers.   "
250836|NCT01139411|"     The purpose of the study is to determine whether a novel model of including parents in     adolescent weight control results in greater decrease in adolescent z-BMI compared to an     intervention with minimal parent involvement.   "
250837|NCT01139424|"     Patients with suspected leakage at the specified surgical anastomoses undergo an immediate     diagnostic endoscopy as part of current clinical routine. Consenting patients meeting the     inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to     standard surgical care.   "
250838|NCT01139437|"     Human parainfluenza virus type 2 (HPIV2) can result in severe respiratory illness in infants     and young children. This study will test the safety of and immune response to an HPIV2     vaccine aimed at infants and children.   "
250839|NCT01139450|"     The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic     Dermatitis.      Treatment medication will be administered as follows: Apply a thin layer of ointment to     affected skin areas twice daily and rub in gently and completely. Study medication will be     applied twice a day, approximately 12 hours apart, for approximately 4 weeks.   "
250840|NCT01139463|"     Blood lactate levels in patients receiving typical or atypical antipsychotics have not been     described in the literature.      The goal of this study is to assess the dynamics of lactate levels in the blood from typical     or atypical antipsychotics not confounded by prior antipsychotic treatments, the     investigators conducted a prospective study of lactate levels in patients receiving     antipsychotic medication. The investigators hypothesized that 6 months of treatment with     haloperidol or olanzapine would result in a change in blood lactate levels and extrapyramidal     side effects.   "
250841|NCT01139476|"     Background:      - Multiple myeloma (MM), a type of cancer that affects the white blood cells, is often     preceded by a precancerous disorder known as monoclonal gammopathy of undetermined     significance (MGUS). Farmers and other agricultural workers have a higher risk of developing     MGUS and MM, possibly because of their exposure to certain pesticides. Researchers are     interested in studying biological specimens taken from participants in the Agricultural     Health Study specifically, pesticide applicators at least 50 years of age who do not have     cancer to better understand the development of MGUS and MM.      Objectives:        -  To collect biological specimens from Agricultural Health Study participants for further          research.        -  To examine the relationship between pesticide exposure and MGUS/MM.      Eligibility:      - Male pesticide applicators who are over 50 years of age, cancer-free, and participating in     the Agricultural Health Study.      Design:        -  Two groups of participants will complete the study: a general group and a smaller group          of individuals who have been exposed to the pesticide diazinon.        -  All participants will receive an initial contact letter with information about the          study, followed by a phone call to administer a screening questionnaire and arrange a          home visit from a researcher within the next month.        -  Participants will receive by mail a urine specimen kit that will be collected at the          home visit.        -  During the home visit, a study researcher will take blood samples and collect the urine          sample, and will administer another questionnaire.        -  Participants in the group exposed to diazinon will have three home visits for the study:          (1) prior to pesticide exposure, (2) the day after participants stop using diazinon, and          (3) about 21 days after the second visit. The first visit will take place in the          off-season from January to March; the second and third visits will be conducted between          April and August.        -  No treatment will be provided as part of this study.   "
250842|NCT01139489|"     This is a randomized controlled trial comparing standard-of-care therapy of infections in     critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics     consumption) and safety (mortality).   "
250843|NCT01139502|"     This study will compare the effects of cognitive behaviour therapy (CBT) and cognitive     training in work rehabilitation of patients with severe mental illness (psychoses).      These interventions will be compared with a matched control group ('treatment as usual'). The     patients will be recruited in nine different counties in Norway. During a two-year period     around 27-30 patients can be recruited from each county, meaning that each intervention arm     will contain approximately 80 patients. The evaluation of the patients will include several     validated diagnostic instruments as described below. The counties has been randomised to the     two different intervention groups by a neutral institution: 1.group receiving work     rehabilitation based on cognitive behaviour therapy, and 2.group receiving cognitive     training. The control group will be matched according to gender and age. With Ntotal=160 for     the comparison of two groups (80 patients x 2), a 0.05 level of significance and a power of     0.80, a standardised group difference of 0.44 can be detected. The standardised difference     detected between supported employment and treatment as usual has been as high as 0.80 in     comparable American studies, indicating that N is large enough in the present study.      The participants in each county will be evaluated and followed by a local project coordinator     and by a local psychiatrist/psychologist in a District Psychiatric Centre. Written evaluation     protocols will be sent anonymously to the research centre for registration. Data will be     stored according to current laws of person protection and data security. Pre-post differences     in each group, differences between the control group and the intervention groups, and     differences between the intervention groups will be tested using a mixed linear model     programme.      Research questions The project will compare the effects of CBT oriented work rehabilitation     and work rehabilitation with cognitive training with regard to the ability of persons with     severe mental disorders to cope with and keep a job. The two intervention arms will be     compared with each other and with a matched treatment as usual control group.      Main hypotheses        1. By the end of the project (T2) and by follow up examination (T3) the global psychosocial          function of patients will be higher in the CBT work rehabilitation group than in the          control group        2. The global psychosocial function of patients at T2 and T3 will be higher in the          cognitive training group than in the control group   "
250844|NCT01139515|"     The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK)     characteristics to those seen in other populations.   "
250845|NCT01139528|"     A multi-site randomized controlled trial where patients are allocated to operative treatment     or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal     is to identify which degree of angular displacement in the fracture that requires operative     intervention.   "
250846|NCT01139541|"     The purpose of the study is to learn more about effective ways to motivate people to increase     their non-exercise energy expenditure exercise. This is an important research question     because obesity and weight-related issues are increasingly becoming a problem in America.     This project will address this research question by testing the effect of group dynamics in     motivating employees who are predominantly sedentary to use Walkstations at work. The     Walkstations are treadmills that move at a very slow rate (maximum 2miles / hour) and are     attached to a work station (i.e. with computer and telephone); they therefore are designed to     increase energy spent not through heavy exercise, but through small changes in posture and     movement associated with routines in daily life (called nonexercise activity thermogenesis or     NEAT). The proposed study is designed to build upon previous research (Levine et al., 2005)     suggesting the role of NEAT-enhanced behaviors in weight loss.      In this study, the investigators are interested in the impact of group dynamics on the     propensity to use the Walkstations. Participants in the active arms will be asked to use the     Walkstations for at least 3 hours per week. They will do so by signing up for a time slot.     During their session, they will be asked to log into the scheduling system to indicate that     they are using the Walkstation. Walkstation usage will be assessed by log-in data: employees     will log-in to the phone and computer when they use the Walkstation. This log-in data is     work-station specific; therefore the investigators will be able to tell when a given subject     used the Walkstation.      Subjects will be randomly assigned to one of three conditions:        1. Individual. In the individual condition, participants will not be part of a team. They          will receive weekly email feedback on their Walkstation performance (e.g. number of time          slots they signed up for, and number of times they showed up for the time slot.)          Participants will also receive a wellness tip in each email. (see appendix for a sample          email)        2. Pairs. In the pair condition, participants will be randomly assigned to a partner. They          will receive the same feedback as those in the individual condition, for both themselves          AND their partner.        3. Group. In the group condition, participants will be randomly assigned to a group of 5          people. They will receive the same feedback as those in the individual condition, for          both themselves AND each member of their group.   "
250847|NCT01139567|"     The purpose of this study is to investigate the safety and efficacy of an optical device     designed and developed to quantitatively monitor blood flow velocity of wound sites. The     hypothesis is that the blood flow velocity of the wound site will provide critical     information on the efficacy of hyperbaric oxygen therapy.   "
250848|NCT01139580|"     The purpose of this study is to determine the safety and effectiveness in the treatment of     psoriasis on the scalp and on the body.   "
250849|NCT01139593|"     This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI     when taking their gonadotropin dosage in the morning (am) or evening (pm).   "
250850|NCT01139606|"     Introduction:      Vibration has been used to enhance muscle strength development during resistance training.      Aim:      To assess the effect of adding vibration to a regular resistance training program, using free     weights, on muscle strength and everyday functioning of upper limbs in untrained adults      Methods:      60 healthy untrained adults, 30-65 yrs, will divide into two groups: experiment and control.     Training program will include 24 sessions, over a course of 8 weeks. The experiment group     will use a 1 kg vibrating weights and the control group will use a standard 1 kg free     weights. Every session will include 10-15 min of 3-5 standard resistant exercises for upper     limbs. Each subject will perform an Isokinetic evaluation of muscular performance, for upper     limbs, in 3 occasions: before starting the program, immediately after completing the 8-weeks     training program and 4 weeks afterwards, to check the chronic effect of each training regime.     Each subject will complete a DASH (Disabilities of the arm, shoulder and hand) questionnaire     at 4 occasions- as mentioned above and one more time, when completing the first 4 weeks of     the training program, to reject any development of negative effects of the training program,     such as pain or inflammation of the joints .   "
250877|NCT01139957|"     This clinical trial is studying the incidence of cancer in women at increased genetic risk of     ovarian cancer. Gathering information about genetic factors in women with an increased risk     of ovarian cancer over time may help doctors learn more about the disease and find better     methods of treatment and on-going care.   "
250851|NCT01139619|"     Lung cancer is one of the most deadly types of cancer and the leading cause of death in     cancer in Sweden. Five year survival is 10% in men and 15% in women. Approximately 3300     individuals in Sweden are diagnosed each year and the incidence of adenocarcinoma is     increasing. Lung cancer patients are to a great extent currently being diagnosed by     exfoliative cytology. However, new drugs leading to more personalized treatments will demand     more specific classification of tumour types. Today EGFR mutation status is becoming an     important factor when deciding treatment strategy for patients with Non-Small Cell Lung     cancer.      Sufficient tumour material must be available if EGFR mutation status is to be tested. Core     needle biopsy is one way to obtain the quantity of material needed when testing mutation     status. The portion of patients having core needle biopsies is believed to vary greatly     between hospitals in Sweden, a difference from 20% to 70 % have been assumed, but is not yet     confirmed in studies. This study will investigate the current situation and procedures when     patients are diagnosed with lung cancer. The results can be used to describe any possible     adverse events connected to the procedure and possibly contribute to development of a better     decision tool to be used when deciding if a core needle biopsy is to be performed or not.      More and more therapeutical targets having similar problems are likely to be developed in the     future. An investigation of current quality and procedures when diagnosing lung cancer by     biopsies will facilitate future diagnosing of lung cancer and ensure that personalized     treatments can be offered to patients.   "
250852|NCT01139632|"     The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is     CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population.     The aim of the investigators study is to diagnose early coronary artery disease in NAFLD     patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with     patients with combination of CAD, unstable plaque and NAFLD.   "
250853|NCT01139645|"     This prospective, single-blind, matched controlled study aims to evaluate the effect of     proton pump inhibitors on biochemical markers of calcium and bone metabolism in an effort to     establish additional biological plausibility for the apparent association between proton pump     inhibitors (PPIs) and osteoporosis-related fractures.      Young males (age 18-45 years), who are either healthy volunteers, or who complain of daily or     frequent heartburn but are otherwise healthy, will be recruited and enrolled in the study.     Patients with heartburn will be assigned to the intervention group and will be assigned to     take a PPI for three months. Healthy volunteers will be matched by age to patients in the     intervention group and will act as the control group. 70 patients will be enrolled in total.     Blood studies for all subjects will be taken at 0, 1 and 3 months to test for various     biochemical markers of calcium and bone metabolism, which act as surrogate markers of calcium     absorption and bone remodeling.      Levels of biochemical markers in the two groups will be compared using two-way analysis of     variance (ANOVA). Changes in biochemical parameters within a group will be assessed using     repeated measures ANOVA.   "
250854|NCT01139658|"     Observational cohort study on the prevention of venous thromboembolic events after elective     orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated     with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions   "
250855|NCT01139671|"     Wisdom teeth removal under general anaesthesia is usually suitable for ambulatory surgery.      The choice of opioid in dental day surgery is based on the need for a rapid and full     recovery, as well as less morphine administration. Whether remifentanil can achieve these     goals remains to be proved, especially regarding remifentanil-induced hyperalgesia, the     potential prolonged Post Anesthesia Care Unit (PACU) stay, or remifentanil-induced workload     for nurses.   "
250856|NCT01139684|"     A test of the validity of repeated sprint test (RST) 4x 30 meters, against the Wingate     Anaerobic Test, which is the gold standard for measuring human anaerobic capacity. The     following variables will be used: peak power, mean power and fatigue index. In addition, it     will be tested against a 50 meter and a 200 meter shuttle run.   "
250857|NCT01139697|"     The purpose of this study is to determine whether hair cortisol and testosterone levels     correlate with heart failure status in patient with chronic congestive heart failure.   "
250858|NCT01139710|"     This prospective study was conducted to explore clinical characteristics and outcomes of     patients diagnosed with pulmonary sarcoidosis and PH. The investigators also assessed the     role of D -dimer levels in these population.   "
250859|NCT01139723|"     This is a Phase I, first-in-human, open label, dose-escalation study of MINT1526A     administered alone and in combination with bevacizumab by IV infusion every 3 weeks to     patients with advanced solid tumors for whom standard therapy either does not exist or has     proven to be ineffective or intolerable.   "
250860|NCT01139736|"     Irritable bowel syndrome is a common digestive disorder worldwide. However, there is no     effective treatment of irritable bowel syndrome. Visceral pain thresholds in response to     stress are lower in patients with IBS compared to healthy volunteers, but the triggers to     visceral hypersensitivity remain largely unknown. Animal models suggest roles for both host     immune response and intestinal bacteria in the induction of visceral hypersensitivity. For     instance colorectal distension increased in association with an alteration in bacterial flora     induced by antibiotic therapy, which suggest a relationship between bacterial gut content and     visceral afferent processing. Intestinal bacteria play a significant role in inducing IBS.     Clinical studies have shown that manipulation of the commensal microbiota with probiotic     bacteria, in particularly preparations that contain bifidobacteria, can alleviate IBS     symptoms. Serotonin (5-HT) plays a crucial role in the regulation of gastrointestinal     physiology and alterations in mucosal serotonin signaling is a possible mechanism of altered     function and sensation in patients with IBS. Impairment of serotonin reuptake transporter     (SERT) expression and function may also play a role in IBS. The investigators hypothesise     that bacteria modulate sensory afferent and serotonin signaling necessary for visceral     sensation and that these pathways can be targeted for therapy of IBS using probiotic     bacteria. The first part of this study will be a cross-sectional study comparing the colonic     microbiota and SERT polymorphisms in IBS patients and healthy controls. The second part will     be an open-label pilot study to assess the effects of oral probiotic bacteria in visceral     hypersensitivity and mucosal microbiota in patients with IBS. Clinical response will be     assessed based on IBS symptom score and rectal sensitivity, and changes in mucosa microbiota     will be measured using 454 pyrosequencing. This proposal will provide novel data on gut     microbiota in Asian IBS patients, and explore the mechanisms underlying visceral     hypersensitivity to direct future targeting of therapy in IBS.   "
250878|NCT01139970|"     This phase I clinical trial is studies the side effects and best dose of giving veliparib     together with temozolomide in treating patients with acute leukemia. Veliparib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving veliparib     together with temozolomide may kill more cancer cells.   "
250861|NCT01139749|"     Oral isotretinoin is the gold standard drug to treat moderate to severe acne. Other     indications like seborrhea, seborrheic dermatitis have been suggested. There is risk of     reversible mucocutaneous side effects, as well as alterations in lipid profile and     transaminases. The major problem is teratogenicity which demands pregnancy control from     treatment beginning to one month after treatment end. Seborrhea and seborrheic dermatitis are     chronic conditions characterized by oily skin, hair and scalp, erythema, desquamation and     negative impact on quality of life. This will be an interventional, therapeutic and quality     of life randomized, comparative (parallel groups), blinded evaluation clinical trial,     comprising 50 men and women, aged 18 to 40. Treatment with low-dose oral isotretinoin will be     compared to topical anti-seborrheic products to evaluate the reduction of sebaceous secretion     and colonization of affected areas by yeasts of Malassezia gender. Efficacy will be evaluated     by clinical parameters, as well as by sebum secretion measure and application of quality of     life questionnaires. Safety will be evaluated by skin hydration measure, side effects report     and observation. For subjects using oral isotretinoin blood counting, transaminases, lipid     profile and pregnancy test will be requested as selection criteria, on days 30 and 180. Data     will be submitted to statistical analysis.   "
250862|NCT01139762|"     The purpose of this study is to investigate the efficacy and safety of once daily tadalafil     when taken with finasteride as a treatment for men with signs and symptoms of Benign     Prostatic Hyperplasia and demonstrable prostate enlargement.   "
250863|NCT01139775|"     LY2603618 is a potent and selective inhibitor of the deoxyribonucleic acid (DNA) damage     checkpoint kinase 1 (Chk1). It is being developed as a chemotherapeutic-enhancing agent in     the treatment of cancer. Ongoing Phase 1 studies have shown the feasibility of combining     LY2603618 with either gemcitabine or pemetrexed. The objective of this study is to find the     dose of LY2603618 that can be safely combined with standard doses of pemetrexed and cisplatin     and to test if this triplet offers a significant improvement in progression-free survival in     participants with Stage IV nonsquamous non-small cell lung cancer (NSCLC) in the first-line     of palliative treatment.   "
250864|NCT01139788|"     Study CXBA is a multicenter nonrandomized, dose escalation, open-label, Phase 1 study of     intravenous LY2624587 in patients with advanced or metastatic cancer for which no treatment     of higher priority exists.   "
250865|NCT01139801|"     The purpose of this study is to specifically investigate the efficacy of an alternative     pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an     adjunct to Foley balloon for induction of the unfavorable cervix.   "
250866|NCT01139814|"     The purpose of this clinical study is to collect safety and performance data to support a     demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to     predicate devices when used to perform EP mapping of the right heart (atrium and ventricle).   "
250867|NCT01139827|"     Framingham risk score is well known screening tool that detect cardiovascular (CV) risk. But     it is not suitable for CV risk in mild risk group. So 18F-fluorodeoxyglucose positron     emission tomography (FDG-PET) is a new imaging technique for detecting vascular inflammation     within atherosclerotic plaques and hsCRP is also arising detection tool of CV risk.      The investigators are examining this association in normal and impaired glucose tolerance     patients groups.   "
250868|NCT01139840|"     Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the     same dose of vitamin D3.   "
250869|NCT01139853|"     The overall objective of this research study is to determine the effect of a pre-operatively     placed nasogastric tube compared to no nasogastric tube, on post-operative emesis rates and     postoperative length of stay in infants with a primary diagnosis of pyloric stenosis treated     with pyloromyotomy. This study will also examine the feasibility data of the pilot data to     develop estimates of treatment effect of a pre-operative nasogastric tube on post-operative     rate of emesis and length of stay to be used to determine the sample size of the definitive     trial.   "
250870|NCT01139866|"     This is an extension to a previous research trial testing SABER™-Bupivacaine (an experimental     pain-relieving medication). The purpose of this extension trial is to assess whether     treatment with SABER™-Bupivacaine or SABER™-Placebo has had any effect on healing of the     participant's shoulder, wound, or the skin near their scar. This trial will also assess     safety (side effects).   "
250871|NCT01139879|"     To assess the efficacy of a pressure ulcer treatment mattress, the P400 mattress, in the     treatment of multiple Stage II or one or more large Stage III or IV pressure ulcers in the     home care and extended care (nursing home) environment.   "
250872|NCT01139892|"     Purpose:      Phase 1: (Pilot Phase)      To compare the treatment efficacy of surgical clipping and endovascular coiling for     unruptured intracranial aneurysms.      To obtain better estimates of morbidity and mortality related to a surgical or endovascular     treatment strategy at one year within the context of an RCT.      To show that an RCT comparing the morbidity and mortality of a surgical management strategy     to an endovascular management strategy is feasible.      Phase 2:      To compare the results of surgical and endovascular management strategies, in terms of:        1. Overall mortality and morbidity at 1 and 5 years.        2. The clinical efficacy and safety of a surgical or endovascular management strategy at 1          and 5 years      Hypotheses: Phase 1 Hypotheses:        1. Surgical clipping of intradural, saccular, unruptured intracranial aneurysms is superior          to endovascular management in terms of a lesser number of patients experiencing          treatment failure.        2. An RCT comparing the clinical outcomes of a surgical versus endovascular management          strategy is feasible.      Phase 1 Primary End-points:      • Treatment failure, hereby defined as having occurred when either: the intended initial     modality (surgical or endovascular) fails to occlude the aneurysm, a major (saccular)     angiographic aneurysm recurrence is found, or an intracranial hemorrhagic event occurs during     the 1-year follow-up period.      Phase 1 Secondary End-points:        1. Overall morbidity and mortality at one year.        2. Occurrence of morbidity (mRS >2) or mortality following treatment.        3. Occurrence of failure of aneurysm occlusion using the initial intended treatment          modality.        4. Occurrence of a major (saccular) angiographic aneurysm recurrence.        5. Occurrence of an intracranial hemorrhage following treatment.        6. Peri-treatment hospitalization lasting more than 5 days        7. Discharge following treatment to a location other than home      Treatment:      Trial feasibility, or the capacity for patient recruitment, would require enrollment of at     least 8 patients per actively recruiting center per year.      Phase 2 Hypotheses:      It may be too early to explicitly define the primary hypothesis of Phase 2, however, the     intent of Phase 2 can be expressed as:        1. One management strategy is superior to the other in terms of clinical outcome at five          years.        2. One management strategy is superior to the other in terms of clinical efficacy at five          years.   "
250873|NCT01139905|"     To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai     children.   "
250874|NCT01139918|"     This exploratory study will be used to identify questions that will be part of a new QoL     questionnaire for patients with psoriasis and psoriatic arthritis and to determine the sample     size needed for its validation. The new questionnaire will be a global QoL questionnaire     which will take into account the impact of both psoriasis and psoriatic arthritis on QoL.      STUDY OBJECTIVES        -  To evaluate the influence of psoriasis and psoriatic arthritis on patient's answers to          QoL questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36.        -  To identify an equal number of questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36          where answers are mostly influenced either by psoriatic arthritis or by psoriasis.   "
250879|NCT01133561|"     The study will assess the effectiveness of Pioglitazone on cellular and clinical levels in     terms of improvement of both skin and systemic manifestations of psoriasis.      The investigators assume that pioglitazone (one of thiazolidinediones readily available in     Egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in     addition to improving the insulin resistance in peripheral tissues observed in many psoriatic     patients and causing metabolic syndrome. This will allow to give a safer therapy than the     available ones for psoriasis and to treat the patient in a more global perspective.   "
250880|NCT01133574|"     This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance     imaging (Part B)   "
250881|NCT01133587|"     To meet the requirement for increased patient involvement, several Community Mental Health     Centres (CMHC) have initiated a service called patient-guided admissions. The investigators     will compare a group with patient guided admission/self-referral to inpatient beds with a     group having treatment as usual.      It is expected that patients in the intervention group will experience more increased feeling     of coping (patient activation) after 4 months and 12 months as a result of participating in     patient-guided admissions than patients getting treatment as usual. In addition the total     number of inpatient days either in the CMHC, psychiatric hospital or community rehabilitation     centre is expected to be clearly lower in the intervention group than in the     'treatment-as-usual' group during one year after intake. Also the number of involuntary     admissions either as inpatient or outpatient will be significant lower in the intervention     group than the 'treatment-as-usual' group.The number of admissions in CMHC and psychiatric     hospital, as well as the number of outpatient consultations in primary care, CMHC and     psychiatric hospitals, will be lower in the intervention group than in the     'treatment-as-usual' group. Patients in the intervention group will experience improved     mental health, increased feeling of coping (patient activation) and increased experience of     recovery after 4 months and 12 months as a result of participating in patient-guided     admissions.   "
250882|NCT01133600|"     The purpose of the study is to evaluate the overall burden to the participant (economic,     quality of life, patients satisfaction and freedom from side effects) when treating Gram     positive infections of the foot in diabetic adults with daptomycin versus vancomycin.   "
250883|NCT01133613|"     The objective of the study is to determine the safety and tolerability of two different     formulations of BMP-7 for the treatment of osteoarthritis of the knee.   "
250884|NCT01133626|"     The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis     function.   "
250885|NCT01133639|"     This will be a randomized double-blind placebo-controlled clinical trial that will accept all     eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be     randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg     orally every 8 hours for five days) plus standard of care or placebo plus standard of care.     The purpose of this study is to evaluate the effects of ketorolac plus standard of care on     post-operative pain control and radiographic osseous healing. Patients will be assessed for     pain via a validated pain questionnaire and for delayed unions via a radiographic scoring     system shown to have both high inter- and intra-observer reliability by a blinded board     certified radiologist. Additional outcomes of bunionectomy procedures will also be evaluated     including adverse events and time to regular shoe gear and activities.   "
250886|NCT01133652|"     Children fear having an intravenous (IV) needle placed because of the pain that they will     experience. The more needle punctures that a child has to endure before the IV is     successfully placed, the greater the pain experienced and anxiety suffered. In addition,     false starts increase the demands on medical staff and can increase the length of the     emergency department stay. Often, veins are difficult to see or feel, particularly in an     unwell, dehydrated child or in young infants who have more fat below the skin surface. Also,     the venous pattern below the skin surface naturally varies from person to person and     therefore success in placing IVs leaves room for improvement. Technology may be able to play     an important role is improving the rates of success. The investigators wish to investigate     whether the use of either an Ultrasound machine or a VeinViewer machine can improve the rate     of success of the initial attempt (skin puncture) at peripheral IV placement in comparison to     the current standard approach.   "
250887|NCT01133665|"     The purpose of this study is to study specific FcRIIIa polymorphisms and their correlation     with clinical outcome in subjects treated with cetuximab and lenalidomide.   "
250888|NCT01133678|"     Primary      Compare response rates to induction chemotherapy consisting of cisplatin/paclitaxel/cetuximab     +/- everolimus.      Secondary      Determine the maximum administered dose (MAD), maximum tolerated dose (MTD), dose limiting     toxicity (DLT), and safety of everolimus with cisplatin/paclitaxel/cetuximab induction     chemotherapy.   "
250889|NCT01133691|"     -  Background: Fasting is mandatory for safety of anesthesia in elective surgery and          imaging but gives rise to discomfort, hunger and thirst especially in children.          Internationally accepted fasting times are often prolonged because of organisational          delay in operating theatre.        -  Hypothesis: Clear fluids can be ingested until an imaginary anesthesia induction time          without enlarging the residual gastric contents compared to overnight fast. There is no          difference between residual gastric contents after 4 hours of fasting after a light meal          compare to 6 hours in healthy children.        -  Examination of gastric volume using magnetic resonance imaging after overnight fasting          and subsequent scans after either clear fluid intake or intake of a standard breakfast          are performed in children aged 6 - 12 years. Time course after fluid intake is followed          with scans every half hour for 2 hours. In the breakfast group 4 versus 6 hours fasting          time will be simulated, e. g. intake of clear fluid is allowed for 2 versus 4 hours          after the meal. Volume of gastric contents will be compared with a standardized          ultrasonographic view of the stomach.   "
250890|NCT01133704|"     This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous     antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic,     hormone-refractory prostate cancer.   "
250932|NCT01140191|"     The objectives of the study are to evaluate the safety, pharmacokinetics (PK), and efficacy     of open label treatment with WR 279,396 (Topical Paromomycin/Gentamicin Cream)in subjects     with cutaneous leishmaniasis (CL).   "
250891|NCT01133717|"     Obstructive sleep apnea (OSA) is a prevalent sleep breathing disorder in the general     population in which recurrent collapse of the upper airway occurs during sleep. OSA is more     prevalent in subjects with stroke and is associated with a 3 fold increased risk of stroke.     This makes it a serious public health problem. Approximately 50% of subjects with OSA are     asymptomatic and are often only detected following investigation for the cause of heart     disease or a stroke. In subjects who are treated for OSA many are intolerant or poorly     compliant with treatment. Therefore, the identification of those subjects with OSA most at     risk of adverse consequences such as stroke is important, so that treatment compliance can be     improved.      Therfore, the investigators want to determine if compared to subjects without OSA, subjects     with OSA have evidence of increased stroke risk by assessment of changes in cerebral blood     flow (cerebrovascular reactivity) as measured on Doppler ultrasound of the middle cerebral     artery (TCD) and blood oxygen level-dependent magnetic resonance imaging of patterns of     cerebral blood flow (BOLD MRI) to two stimuli. These stimuli include increased carbon dioxide     concentrations (causes increased cerebral blood flow) and reduced oxygen concentrations     (causing decreased cerebral blood flow). In order to deliver these stimuli the investigators     will use a special machine (RespiractTM) which allows for the precise control of carbon     dioxide and oxygen concentrations in the lungs and blood. The precise control of carbon     dioxide and oxygen in conjunction with BOLD MRI has enabled the production of detailed maps     of the brain that identify areas of healthy and abnormal blood supply.   "
250892|NCT01133730|"     Hand or wrist surgery often requires the use of bony material in order to accomplish any     associated reconstructive aspects required for the surgery. The iliac crest is often used as     the source of bone for such surgery and harvesting from this site is performed simultaneously     with the hand/wrist surgery. In terms of anesthesia, patients typically receive a     supraclavicular nerve block for the hand/wrist surgery, and a general anesthestic for the     bone graft, though spinal block may also be performed. This study will look at the use of a     transversalis fascia plane (TFP) nerve block (ie, to numb the nerves going to the iliac     crest) in combination with a general anesthetic to see if post-operative pain and opioid     consumption is reduced using the TFP block.   "
250893|NCT01133743|"     This is a phase II, non-randomized, single institution study in symptomatic, previously     untreated CLL patients. All patients will receive the study drug, lenalidomide, given PO     daily continuously on a 28 day cycle at the starting dose level of either 2.5 mgs or 5 mgs     with dose escalations to a target dose of 25mg daily. Oral dexamethasone at 12 mg PO daily     will be administered on days 1-7, 14 and 21 of each cycle. Patients will be treated with     lenalidomide and dexamethasone to 2 cycles past CR or to a maximum of 18 cycles, each cycle     of 28 days duration. Primary endpoint is response.   "
250894|NCT01133756|"     The purpose of this study was to determine the maximum tolerated dose (MTD)/recommended Phase     II dose of lenvatinib administered in combination with carboplatin and gemcitabine (Phase IB)     and to evaluate the safety and tolerability of E7080 administered in combination with     carboplatin and gemcitabine compared to carboplatin and gemcitabine alone (Phase II) in     participants with platinum-sensitive recurrent ovarian cancer.   "
250895|NCT01133769|"     About 90% of chest injuries in America are due to blunt forces, mostly as a result of motor     vehicle collisions and falls. Severity varies from minor bruising to severe chest injuries.     For several years, clavicle (collarbone) fractures have been treated without surgery     (non-operatively), even when the fracture is out of place (displaced). Over the last few     years, however, treatment has changed more towards surgical fixation (operative), because of     the sometimes difficult healing in clavicle fractures that are displaced. Several research     studies have shown that cases in which the clavicle fracture never heals completely     (non-union) are more frequent after nonoperative treatment, compared to operative fixation.     In those cases, surgery is still required, only later (secondary surgery). Further, clavicle     malunion, in which the fracture heals but is still out of place) has been shown to be high     after nonoperative treatment. Recent published research studies have shown better function,     higher patient satisfaction, earlier return to activity (use of the arm) and decreased     nonunion and malunion following surgery, also called open reduction/internal fixation.     Despite recent published research, there is still a lack of agreement on when surgical     fixation should be performed for clavicle fractures.      Patients with chest injuries often have clavicle fractures. Chest injuries can restrict     patients' ability to breathe, cough, stand, walk and leave the hospital. Although it is     unusual that chest injuries can be improved with surgery, patients with clavicle fractures     and chest injuries might recover faster if the clavicle fractures were repaired.      Patients are being asked to take part in the study they have sustained a clavicle fracture     associated with a chest injury with or without any other injury to the abdomen, or arms or     legs. The aim of this study is to determine the difference in the hospital length of stay,     intensive care unit length of stay, respiratory rehabilitation (recovery of good respiratory     function), functional outcome, ability to become mobile again, complications and risk of     dying in trauma patients with chest injury and clavicle fracture treated operatively versus     non-operatively.   "
250896|NCT01133782|"     Viral respiratory infections are common worldwide. It has been suggested that nucleic acid     amplification tests, enabling a rapid etiologic diagnosis, may be useful in reducing     antibiotic prescriptions rates. The objective of this study was to evaluate if access to a     multiplex real-time PCR method would have an impact on antibiotic prescriptions for acute     respiratory tract infections (ARTIs), in primary care. Adult patients with respiratory tract     infections will be prospectively included. Nasopharyngeal and throat swabs will be analyzed     with a multiplex real-time PCR method, targeting 13 viruses and two bacteria. Samples will be     collected during the winter season (October-April). Patients will be open-label randomised to     receive a rapid result (the following day) or a delayed result (after 10+/-2 days). The     investigators are planning to include approximately 400 patients. Prescription of antibiotics     will be measured at initial visit as well as at a follow-up visit 10+/-2 days later. Primary     endpoint is antibiotic prescription in the acute phase (initial visit) and secondary endpoint     antibiotic treatment (ongoing or initiated) at follow-up visit. The hypohesis is that access     to a method with the ability of providing a rapid etiologic diagnosis of respiratory     infections will affect the use of antibiotics in outpatient care of adult patients with ARTI.   "
250897|NCT01133795|"     The objective of the study was evaluate the effect of administration of midodrine and albumin     on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.   "
250898|NCT01133808|"     The purpose of the investigators study is to compare the rates of childhood diarrhea at the     community level before and after the rotavirus vaccination program in León, Nicaragua. From     preliminary studies, the investigators anticipate about a 28% reduction in diarrhea following     the vaccination program among children who received the vaccine, and a smaller reduction in     diarrhea among children who did not receive the vaccine, due to the effects of herd     immunity. In addition, the investigators will collect stool samples from children who     develop diarrhea in order determine the etiology of childhood diarrhea in the post-rotavirus     immunization era.   "
250900|NCT01133834|"     Objectives:      Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to     irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During     meningococcal sepsis and meningitis, a myriad of cells release cytokines within the     intravascular environment and subarachnoid space. Cytokines are key molecular messengers that     play key roles in orchestrating and mediating the metabolic, endocrine and coagulation     responses to meningococcal infection. The aim of the present study is to determine the     profile of different cytokines in serum and cerebrospinal fluid during MD, as well as relate     the level of these cytokines to severity of MD.      Design:      Prospective, nonrandomized study.      Setting:      Tertiary referral intensive care unit.      Patients:      Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and     cerebrospinal fluid will sample from children and adults with MD.   "
250901|NCT01133847|"     The objective of this randomized clinical trial is to address unanswered questions about the     relative effectiveness of treatments for children with both Attention Deficit Hyperactivity     Disorder (ADHD) and significant reading difficulties (RD). The study evaluates attentional     and word reading outcomes for students with both conditions when provided with either (a)     ADHD treatment alone, (b) RD treatment alone, or (c) the combination of ADHD and RD     treatment.   "
250902|NCT01133860|"     The term MYH9-related disease (MYH9RD) includes four genetic disorders: May-Hegglin anomaly,     Sebastian syndrome, Fechtner syndrome, and Epstein syndrome. All these disorders derive from     mutation of a unique gene, named MYH9, and they have been recognized as different clinical     presentations of a single illness that was named MYH9RD. All patients affected by MYH9RD     present since birth with thrombocytopenia, which can result in a variable degree of bleeding     diathesis; some of them subsequently develop additional clinical manifestations, such as     renal damage, sensorineural hearing loss, and/or presenile cataracts. Eltrombopag is an oral     thrombopoietin receptor agonist that stimulates proliferation and differentiation of     megakaryocytes, the bone marrow cells that produce blood platelets. This drug is effective in     increasing platelet count in healthy volunteers, as well as in patients affected by some     acquired thrombocytopenias, such as idiopathic thrombocytopenic purpura and HCV related     thrombocytopenia. The purpose of this study is to determine if eltrombopag, administered     orally at the dose of 50 or 75 mg/daily for up to 6 weeks, is effective in increasing     platelet count of patients affected by MYH9RD. Further aims of this study are to test if     eltrombopag is effective in reducing bleeding tendency of MYH9RD patients; to evaluate safety     and tolerability of eltrombopag in patients with MYH9RD; to evaluate in vitro function of     platelets produced during therapy in patients responding to this drug.   "
250903|NCT01133873|"     The purpose of this study is to determine the daily maximum tolerated dose of propoxyphene     napsylate in healthy subjects.   "
250904|NCT01133886|"     The purpose of this study is to assess the response rate at 6 months in Myelodysplastic     Syndrome (MDS) patients, Chronic Myelomonocytic Leukaemia (CMML-2) patients, and Acute     Myeloid Leukaemia (AML) patients with up to 30% bone marrow blasts, treated with low-dose     decitabine who have previously failed therapy with 5-azacitidine.   "
250905|NCT01133899|"     Glycocyamine (guanidinoacetic acid - GAA) is the biochemical precursor of creatine, which is     phosphorylated and plays an important role as a high-energy carrier in the muscle. Since GAA     can be administered in liquid solutions, such as sports drinks, it could be hypothesised that     GAA could easily enhance creatine biosynthesis with clear physiological effects yet to be     determined. No single study has examined the influence of GAA on health, human performance or     body composition indicators in healthy human subjects. Moreover, the most effective dose of     GAA is yet to be find. Finally, the adverse effects of GAA supplementation in humans are not     determined. The main aims of the present study will be to identify if the 6-weeks of GAA     supplementation improves human performance and body composition, to determine most effective     dose regimens of GAA, and to analyze adverse effects of GAA supplementation. Forty eight     healthy, trained (> 2 yr training experience) male and female subjects (aged 20 to 25 years)     will give their informed consent and volunteer to participate in the study, which will obtain     the approval of the University's Ethical Advisory Commission. The subjects will be allocated     to four randomly assigned trials: ingesting GAA (1.2, 2.4, 4.8 g of GAA in a single dose) or     placebo (PLA) for 6 weeks in a double-blind design. All testing including blood and urine     samples, body composition and muscle strength and exercise performance (both aerobic and     anaerobic) will be conducted at presupplementation (baseline), at 1 week, at 2 weeks, at 4     weeks, at 6 weeks of supplementation and at 8 and 10 weeks (2 and 4 weeks after the end of     supplementation) to analyze wash-out period. According to previous investigations, the     investigators expect that ingestion of GAA will significantly increase both serum creatine     and total homocystein. The investigators expect that ingestion of GAA will significantly     improve muscle strength parameters and exercise performance results as compared to placebo in     long term. The investigators also expect to find prevalence of side-effects (i.e.     gastrointestinal distress, retention of fluid).   "
250906|NCT01133912|"     Primary objectives :      1. To evaluate the recommended dose of the combination of paclitaxel, gemcitabine, and     lapatinib (Tykerb®) (PGT) as preoperative chemotherapy in patients with HER2 positive     operable breast cancer      Secondary objectives :        1. To evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of PGT        2. To determine the safety profile        3. To assess pCR in primary tumor and axillary LN        4. To evaluate clinical response rate, disease free survival (DFS), and overall survival          (OS)        5. To assess breast conserving rate after preoperative PGT   "
250907|NCT01133925|"     Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the     use of overlapping drug-eluting stents. Whether the substantial impairment of arterial     healing observed at sites of overlap in preclinical pathologic studies persists in patients     undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels     requiring stents in overlap are prospectively assigned to receive multiple zotarolimus     eluting stents (Resolute Sprint). The completeness of stent struts coverage and/or late     malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up.Data will     be compared to the historical arm of ODESSA trial (patients treated with multiple     sirolimus-,paclitaxel polymer-or zotarolimus eluting stents).   "
250935|NCT01140230|"     Few studies are considering acute traumatic rotator cuff tears in previously asymptomatic     patients. The purpose of the current study was to investigate if delay of surgery, age at     repair and the number of cuff tendons involved affected the structural and clinical outcomes.   "
250908|NCT01133938|"     Several risk factors for the development of osteonecrosis of the femoral head following     treatment of developmental dislocated hip have been reported. The need for further research     with a large-enough sample size including statistical adjustment of confounders was demanded.     The purpose of the present study was to find reliable predictors of osteonecrosis in patients     managed for developmental dislocation of the hip and to evaluate if delayed treatment     increased the risk of residual acetabular dysplasia requiring secondary surgeries.   "
250909|NCT01133951|"     Gastric cancer is the fourth most common type of cancer and the second leading cause of     cancer-related death in the world. In China, more than 390,000 new patients are diagnosed     with gastric cancer and more than 300,000 patients are killed by the terrible disease     annually. Although gastric cancer has a multifactorial etiology, infection with H. pylori is     highly associated with gastric carcinogenesis. Therefore, eradication of H. pylori infection     appears to reduce the risk of gastric cancer. However, several recent controlled     interventional trials by H. pylori eradication to prevent gastric cancer have yielded     disappointing results. The exact effect of H.pylori eradication on prevention of gastric     cancer is unclear up to now. To clarify this problem, the investigators conducted a     prospective, randomized, double-blind, placebo-controlled, population-based study to     determine whether H pylori eradication would reduce the incidence of gastric cancer in a     high-risk population in China.   "
250910|NCT01133964|"     The aim of this study is to examine the effect of dairy proteins (whey and casein) on     postprandial appetite regulation and energy expenditure.   "
250911|NCT01133977|"     Primary:        -  Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of          lenvatinib administered in combination with dacarbazine.        -  Phase II: To evaluate the safety and tolerability of lenvatinib administered in          combination with dacarbazine, compared with dacarbazine alone.      Secondary:      -Phase II: To make a preliminary assessment of the efficacy of lenvatinib administered in     combination with dacarbazine, compared with dacarbazine alone.   "
250912|NCT01133990|"     The purpose of the Phase Ib portion is to find out the highest dose of study drug that can     safely be given when tested in a small group of subjects.      The purpose of the Phase II portion is to find out how safe the study drug is when taken at     the highest dose in a larger group of subjects.   "
250913|NCT01134003|"     retrospective and prospective data collection for a database. Patients will have had or are     going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System   "
250914|NCT01134016|"     A phase I study to determine the maximum tolerable dose (MTD) and to evaluate     pharmacokinetic, safety/tolerability and efficacy profiles of antroquinonol (Hocena®) in     non-small cell lung cancer (NSCLC) subjects refractory to conventional treatment modalities   "
250915|NCT01134029|"     The researchers propose a randomized controlled trial to evaluate how well an intervention,     Planned Care for Obesity & Risk Reduction (Planned CORR), supports primary care treatment of     obesity in adults with at least one cardiovascular risk factor (CVRF).   "
250916|NCT01139983|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This research study is studying DNA biomarkers in samples from patients with     osteosarcoma and healthy volunteers.   "
250917|NCT01139996|"     This study will attempt to learn how to better treat trauma patients with delirium who are on     a breathing machine. Delirium, also known as acute, temporary brain dysfunction, is a common     reason why ventilated patients can not be weaned from the breathing machine even though their     lungs may be healthy enough to breathe without the machine. The study hopes to show that by     decreasing the patient's delirium it will lead to quicker weaning from the breathing machine     and possibly a quicker overall recovery as well. Patients enrolled in this study will be     treated with Clonidine or placebo. Clonidine is a drug that produces significant calming     effects, decreases anxiety, and reduces pain, but with a lower incidence of delirium than     other medications used in the ICU for this purpose. Clonidine is not approved by the Federal     Food and Drug Administration for treatment of delirium, but is commonly used for this     purpose.   "
250918|NCT01140009|"     The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1     pandemic of 2009. Many Canadians either had the H1N1 infection or the adjuvanted H1N1     vaccine. Both H1N1 infection and adjuvanted vaccine produced strong immune responses which     could last for some time.      The seasonal influenza vaccine for this fall will be a normal product once again, without     adjuvant. It will contain 3 strains of killed, split-apart viruses that might circulate this     winter, including the H1N1 pandemic strain. It is theoretically possible that giving the     H1N1-containing seasonal vaccine to people who still have some immunity to H1N1 virus could     result in more frequent side-effects. However, there is no good evidence that pre-existing     immunity to a strain in the vaccine does increase side-effects. In short, there could be     nothing out of the ordinary this fall but it would be prudent to check this before public flu     vaccination programs begin.   "
250919|NCT01140022|"     The purpose of this study is to conduct a quality improvement intervention to improve the     ability of health care providers to deliver an important preventive health service (CT     screening) in order to meet the goal of universal CT screening for young women age 25 or     younger as recommended by the CDC and virtually all major health organizations. This novel     approach utilizes a bilingual (English-Spanish) computer kiosk module to deliver education     about CT and allow patients to request a CT screening test. This module should significantly     increase CT screening among at risk women (18-25yo) attending urgent care clinics and     emergency departments.   "
250933|NCT01140204|"     This was a randomized, placebo-controlled, multi-centre study, double-blind within each dose     level, with four ascending dose levels to test the tolerability and safety of     iopromide-paclitaxel in patients with de novo lesions in coronary arteries. Thirty-two     patients were included into the trial, which were divided into four treatment groups. A total     of four concentration levels of paclitaxel-iopromide concentrations were investigated. In     each treatment group, six patients received iopromide-paclitaxel and two patients placebo     (iopromide without paclitaxel). In each patient, the doses were adjusted individually as     needed.   "
250934|NCT01140217|"     The purpose of this study is to determine whether NEA TDS is effective in the prevention of     pregnancy. The safety of this product will also be evaluated.   "
250949|NCT01140529|"     Primary hypothesis: Dexmedetomidine is equal or superior to haloperidol and placebo in the     treatment of psychomotor confusion in patients who are recovering from heart surgery.      Study design:      Multi-centre, prospective, randomised, placebo-controlled double-blind study of     dexmedetomidine vs. haloperidol for treatment of psychomotor confusion after cardiac surgery.     Data will be analyzed in two steps: The primary comparison is between placebo and     dexmedetomidine. If the effect of dexmedetomidine is significant, a secondary comparison     between dexmedetomidine and haloperidol will follow.   "
250920|NCT01140035|"     Every year in the US, there is a shortage of many thousands of kidneys needed for transplant.     Furthermore, kidneys that are available and are transplanted often exhibit delayed or slow     graft function (DGF and SGF, respectively), which lowers quality of life for patients and     their families and requires significant additional medical care. These needs result in     significant but preventable human suffering and health care spending. To address these needs,     the investigators' project will test the use of intensive insulin therapy (IIT) in donors     after neurological determination of death (DNDDs) as an intervention that will decrease acute     kidney injury and improve renal function at the time of organ recovery. This should translate     into a decreased incidence of DGF and SFG in recipients receiving organs from the IIT group.     The investigators also expect to find a trend toward an increase in the number of organs     available for transplant due to better organ protection in the DNDD. Taken together, these     data can provide the requisite justification for a larger study that can be powered to     evaluate the effect of IIT on increasing the number of kidneys available for transplantation.      There is evidence that brain death often leads to hyperglycemia that may negatively impacts     the organs of DNDDs. These observations led us to conduct a retrospective study, in which the     investigators found that hyperglycemia in DNDDs is indeed associated with decreased terminal     renal function. Because it has been reported that intensive insulin therapy (ITT) is     renoprotective in the ICU more than conventional insulin therapy (CIT), the investigators     propose to evaluate the use of IIT on DNDDs to: (1) improve organ function, (2) reduce DGF in     recipients, and (3) possibly increase the number of kidney available for transplant.      Methods: This is a prospective observational study to document the impact of IIT on acute     kidney injury in DNDDS and on allograft function in recipients. DNDDs will be divided into     two groups: CIT and IIT. In the first study, the investigators will evaluate the effect of     ITT on biochemical parameters in blood samples that predict kidney health and function in     DNDDs. All methods used in this proposal are well documented in the literature and     established in the applicant's laboratory. In the investigators' second study, they will     compare the effects of ITT in DNDDs on graft function in allograft recipients in terms of     number of patients showing either DGF or SGF. Additionally, there is currently no established     set of advanced biochemical criteria in DNDDs for predicting kidney function in recipients.     The investigators will correlate the evaluated biochemical markers of kidney function and     health in order to possibly develop more refined methods of predicting transplant success.     Such a set of criteria would be useful for designing studies to systematically test     additional interventions in DNDDs to further improve organ function before recovery and     further increase the number of available organs.      Taken together, the results of this study may lead to new therapies that significantly     improve patient outcomes while significantly reducing disease associated costs. These results     can also set the stage for a follow on study for increasing the number of kidneys available     for transplant.   "
250921|NCT01140048|"     This is a prospective, multicenter, observational study in participants who completed the     24-week, placebo-controlled MK-0476 Protocol 272 (NCT00076973) study of montelukast in the     treatment of respiratory symptoms subsequent to RSV-induced bronchiolitis. The purpose of     this study is to better understand the clinical and demographic correlates of asthma and     atopic disorders in children (through the age of 6 years) with a history of severe     RSV-induced bronchiolitis.   "
250922|NCT01140061|"     This study will evaluate the incidence of erythema and other local cutaneous irritation after     administration of MK-0873 by patch or cream formulation in healthy participants and     participants with mild psoriasis. Part I and Part II in healthy participants will be     initiated prior to Part III in psoriasis participants. The primary hypotheses of the study     are: 1) that MK-0873 is safe and well tolerated in healthy participants and participants with     psoriasis and 2) that the maximum plasma concentration of MK-0873 is <20 nM in healthy     participants and participants with psoriasis.   "
250923|NCT01140074|"     Diarrheal disease is one of the major causes of morbidity and mortality in children under     five. Disease is treated symptomatically with oral rehydration (ORS) as a basic measure. In     children with severe zinc deficiency, diarrhea is common and responds quickly to zinc     supplementation. Zinc supplementation may also helpful in diarrheal children without zinc     deficiency. Effectiveness of zinc was proven in developing countries but was not in Europe.     Objective of our study is to assess whether zinc supplementation given with probiotics and     ORS is effective in acute diarrhea in children in Poland.   "
250924|NCT01140087|"     This study aims to:        1. Perform face transplants on people who have suffered severe facial trauma with tissue          and functional loss; and        2. Evaluate the acceptance and function of the transplanted tissue.   "
250925|NCT01140100|"     The aim of this study is to determine whether induction of anesthesia with thiopental     followed by propofol infusion is able to maintain sufficient depth of anesthesia .   "
250926|NCT01140113|"     The inflammatory response after cardiac surgery increases mortality and morbidity. Modified     ultrafiltration (MUF) has been shown to decrease the post-cardiac surgery inflammatory     response, to improve respiratory function, and cardiac performance in pediatric patients;     however, this approach has not been well established in adults. The investigators therefore     hypothesized that MUF can decrease the post-cardiac surgery inflammatory response and can     improve cardiopulmonary function in adults.   "
250927|NCT01140126|"     The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting     the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and     well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous     infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells. The     neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive     cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1     infection.   "
250928|NCT01140139|"     In this study, the investigators evaluated a therapeutic HIV-1 DNA vaccine administered with     a novel topical application method to 12 chronically HIV-infected cART treated patients. The     HIV DNA plasmids used in this study encode for envelope gp160 of HIV-1 subtypes A, B and C,     rev B, Gag A and B and reverse transcriptase (RT) B. The patients were randomly assigned to     three groups; group 1 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids     topically, group 2 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically     and treated with 500 mg of hydroxyurea daily until visit 10, group 3 (n=4) four patients     received placebo. The immunization was performed during three cycles of 7 weeks of cART     followed by four weeks of therapy interruption. After the last cycle of cART the patients     were maintained on a definitive treatment interruption until CD4+ T cell counts dropped below     350/ mm3 at two time points. Cellular and humoral immune responses, viral load and CD4+ T a     cell count was analysed throughout the study.   "
250929|NCT01140152|"     Many patients with intestinal failure require intestinal transplantation for survival.     Currently, the gold standard for diagnosing acute cellular rejection (ACR) is histological     examination of endoscopic biopsies, which are taken invasively and lack sensitivity. A     non-invasive method of monitoring for ACR is needed.   "
250930|NCT01140165|"     The aim of this study is to examine if a diet rich in cheese will have a beneficial effect on     risk markers of cardiovascular disease compared to a diet rich in butter.      The primary parameters are total cholesterol as well as LDL-, HDL cholesterol and     triacylglycerol (TAG). The secondary parameters are hsCRP, markers of insulin resistance,     fasting insulin and glucose (HOMA). Furthermore bloodpressure is measured.   "
250931|NCT01140178|"     Recent literature suggests that certain patients with squamous cell cancers of the head and     neck region may benefit from photodynamic therapy whether or not they may have received prior     therapy, e.g. radiation therapy   "
250937|NCT01140256|"     Large-scale zinc supplementation studies have demonstrated highly significant positive     effects on growth, morbidity and mortality in infants who are born small for gestational age     (SGA). This suggests these infants may have higher postnatal requirements compared to     appropriate for gestational age (AGA) infants, possibly due to inadequate zinc intake from     breast milk due either to lower volume or to differences in milk zinc concentrations from     mothers of SGA compared to AGA infants. Alternatively, SGA infants may have lower zinc stores     at birth, which may reflect a greater postnatal requirement for optimal zinc status. It is     thus possible that the zinc requirements of the SGA infant exceed the zinc intake that can be     achieved from exclusive breastfeeding, which is recommended for the first 6 mo of life. The     exchangeable zinc pool (EZP) is defined as the estimate of the total size of the combined     pools of zinc that exchange with zinc in plasma within approximately 2-3 days and may also     differ between SGA and AGA infants.        1. Compare longitudinal zinc intake by measuring milk zinc concentrations and volume of          intake of breast milk between SGA and AGA infants through first 12 mo.        2. Compare post-natal growth rates for SGA and AGA infants through the first 12 mo of life          in relation to zinc intake.        3. Compare size of exchangeable zinc pool (EZP) at birth and at 6 mo of age between SGA and          AGA infants.      Hypotheses:        1. Zinc concentrations in human milk will not be significantly different at any stage of          lactation between mothers of SGA infants and mothers of AGA infants.        2. The volume of breast milk intake relative to body weight will be similar between SGA and          AGA infants, but the total intake will be lower in SGA infants.        3. Linear growth rates, rate of weight gain, and rate of growth in head circumference will          be significantly lower in infants born SGA, and will be positively correlated with total          daily zinc intake.        4. The size of the EZP at birth will be significantly smaller in absolute size and relative          to body weight in infants born SGA compared to AGA   "
250938|NCT01140269|"     The purpose of this study is to determine if rapid early detection of the bacteria causing     sepsis in burn patients improves patient outcomes.   "
250939|NCT01140282|"     Rationale: Exercise therapy may improve the quality of life of breast cancer survivors.      Purpose: This randomized clinical trial studies exercise therapy and quality of life in     postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy.   "
250940|NCT01140295|"     The primary objective of this study is to determine whether Miralax results in a more     efficacious preparation as compared to senna for pediatric colonoscopy.   "
250941|NCT01140308|"     Statins (such as simvastatin or Zocor) are the most effective and widely prescribed     medications to lower cholesterol levels and reduce the frequency of heart attacks, cardiac     deaths and strokes. Unfortunately, statins can cause muscle discomfort or pain called     myalgia in patients treated with these drugs. These symptoms often cause patients who need     these medications to stop taking the drug. The cause of statin muscle pain is not known, but     it is thought that a reduction of a vitamin-like substance called Coenzyme Q10 (CoQ10) during     statin treatment may play a role. CoQ10 is a vitamin like substance and is not a drug     approved and regulated by the Food and Drug Administration (FDA). This study will look at the     effects of CoQ10 supplements on individuals who develop muscle symptoms while on simvastatin.      The investigators hope to test the hypothesis that CoQ10 supplementation compared to placebo     in patients with documented statin myalgia reduces the intensity of pain during statin     treatment.   "
250942|NCT01140438|"     The purpose of the study is to clarify whether patients classified as Latent autoimmune     diabetes of the adult (LADA) benefit from early treatment with insulin added to per oral     treatment and lifestyle measures.   "
250943|NCT01140451|"     Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the     cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of     mutation called a nonsense (premature stop codon) mutation is the cause of CF in     approximately 10% of subjects with the disease. Ataluren (PTC124) is an orally delivered     investigational drug that has the potential to overcome the effects of the nonsense mutation.     This study is a Phase 3 extension trial that will evaluate the long-term safety of ataluren     (PTC124) in adult and pediatric patients with nonsense mutation CF, as determined by adverse     events and laboratory abnormalities. The study will also assess changes in pulmonary     function, CF pulmonary exacerbations, health-related quality of life, antibiotic use for     CF-related infections, CF-related disruptions to daily living, body weight, and CF     pathophysiology. Funding Source - FDA OOPD.   "
250944|NCT01140464|"     Major Depression is one of the most common mental health disorders in adolescence and is     associated with significant impairments in development and functioning. This project will     rigorously test the Adolescent Collaborative Care Treatment intervention, a health services     intervention designed to improve management for depressive disorders among adolescents, via a     randomized controlled trial comparing the intervention to usual care. Key components of the     trial include enhanced education for youth and parents, youth involvement in choice of     evidence-based treatments, care management by an allied health professional with regular     supervision by a mental health specialist and pediatrician, and stepped care to advance     treatment when youth are not improving. Additional features have been added to engage     adolescents and parents including a moderated message board for youth to share with and learn     from one another, formalized involvement of the parent, and availability of the care manager     during after school hours. Our findings will provide key information on the effectiveness of     a developmentally-sensitive adapted collaborative care intervention for the treatment of     adolescent depression.   "
250945|NCT01140477|"     The objective of this clinical trial is to evaluate the safety and effectiveness of the     Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide     near, intermediate, and distance vision and a reduction of the effects of preoperative     corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular     lens (IOL) placement.   "
250946|NCT01140490|"     The aim of this study was to evaluate whether successful sub-total parathyroidectomy retards     cardiovascular calcification in patients with hemodialysis and to investigate the mechanism .   "
250947|NCT01140503|"     This study is designed to evaluate the safety and efficacy of an oral medicine (called     apremilast) for treating skin involvement in patients with the disease dermatomyositis.   "
250948|NCT01140516|"     This study focuses on the relationship between prophylaxis antibiotics and frequency of     urinary tract infection in children diagnosed with antenatal hydronephrosis. Hydronephrosis     is the most common fetal abnormality occurring in 1-5% of all pregnancies. Currently, with     the widespread accessibility of antenatal ultrasound across cities in Ontario, the detection     of hydronephrosis has become even more common. As a result, thousands of infants with     hydronephrosis have been seen and managed by pediatricians, pediatric nephrologists,     pediatric urologists, and family physicians. The investigators need to determine if     antibiotic prophylaxis is effective in reducing the number of urinary tract infections in     this population.   "
251002|NCT01141231|"     RATIONALE: Acupuncture may help relieve dry mouth caused by radiation therapy.      PURPOSE: This randomized phase III trial is studying to see how well one set of acupuncture     points work in comparison to a different set of acupuncture points or standard therapy in     treating dry mouth caused by radiation therapy in patients with head and neck cancer.   "
250953|NCT01140581|"     Primary Objective:      - Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization     according to different timings of initiation of dronedarone.      Secondary Objective:        -  Evaluate the rate of AF recurrences two months after randomization.        -  Assess the safety of the change from amiodarone to dronedarone        -  Assess dronedarone safety        -  Explore dronedarone and its active metabolite plasma level (in a subset of countries)        -  Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone          (in a subset of countries)   "
250954|NCT01140594|"     A prospective comparison of eyes undergoing wavefront-guided LASIK in one eye and     wavefront-guided PRK in their fellow eye for myopia.   "
250955|NCT01140607|"     Primary Objectives:        -  To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when          administered to advanced solid tumor patients with varying degrees of hepatic impairment        -  To determine the pharmacokinetics (PKs) of Cabazitaxel in patients with varying degrees          of hepatic impairment        -  To correlate PK variables with pharmacodynamic (PD) safety parameters in order to guide          prescribers with regard to dosing in this patient population        -  To assess the effect of cabazitaxel at recommended dose of 25mg/m^2 on CYP3A enzyme          activity using midazolam as probe in an additional cohort of cancer patients with normal          hepatic function.   "
250956|NCT01140620|"     The primary objective of this study is:      • To determine the effects of ketamine, which blocks the ion-channel gated by the NMDA     receptor, on performance of cognitive tasks and the extent to which these effects can be     reversed by the dopamine receptor antagonist, risperidone.      The secondary objectives of this study are:        -  To establish whether patients with schizophrenia are able to reliably complete the          biomarker test battery and to assess whether their responses are similar to healthy          volunteers treated with ketamine.        -  To establish a multi-site recruitment and assessment capacity based on shared Standard          Operating Procedures across three study centres.   "
250957|NCT01140633|"     Current measures of adherence detect problems weeks to months after they occur. Because the     HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral     therapy, treatment failure may develop before an intervention can be deployed. Real-time     objective adherence monitoring could redirect efforts from a reactive response to the     proactive prevention of treatment failure. Because adherence is so closely associated with     viral suppression, accurate adherence monitoring could also strategically limit viral     monitoring only to those patients at a defined risk for viral rebound.      This observational study is assessing a wireless adherence monitoring device and mobile     phone-based adherence data collection among caregivers of children under the age of ten years     in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility     and acceptability of these measures, as well as circumstances of adherence lapses and other     individual and cultural factors affecting adherence. The qualitative data will be used to     explore models of adherence behavior, which will likely include the child-caregiver dynamic,     the child's mental and physical health, and social support mechanism.   "
250958|NCT01140646|"     RATIONALE: S-adenosyl-L-methionine may help relieve hot flashes in women based upon its     ability to potentially modulate serotonin.      PURPOSE: This phase II trial is studying the side effects and how well     s-adenosyl-L-methionine works in treating hot flashes in women with a history of breast     cancer or those who do not wish to take estrogen due to a perceived increased risk of breast     cancer.   "
250959|NCT01140659|"     Compare the results obtained with video-assisted sympathectomy performed in two distinct     levels ganglionic (third versus fourth thoracic ganglion) for the treatment of palmar     hyperhidrosis, through a blind randomized clinical trial using an objective method to measure     the sweat before and after the operation.   "
250960|NCT01140672|"     The goals of this study are to evaluate the safety and tolerability of multiple ascending     doses of PF-04634817 administered orally to healthy adult subjects. In additional, the plasma     and urinary pharmacokinetics of multiple ascending doses of PF-04634817 administered orally     to healthy adult subjects will be evaluated. Finally, the effect of multiple doses of     PF-04634817 on circulating monocytes will be explored.   "
250961|NCT01140685|"     This work will focus on the anti-inflammatory and antioxidant pathways in lung diseases by     measuring HO-1 in induced sputum and CO in exhaled air in cases of four respiratory diseases,     asthma, chronic obstructive pulmonary disease (COPD), occupational lung diseases (OLD) and     interstitial lung disease (ILD).   "
250962|NCT01140698|"     Up-to-date, the preterm newborn nutrition is based on human breast milk or it's imitations.     However, the growth rate is known to be reduced compared to the fetal growth rate. In order     to attempt a better growth rate of the preterm newborn infants it is important to evaluate     the metabolic components of the fetal blood and try to find components that might influence     its growth.      Little is known of the metabolic components of the fetal blood, including amino acid profile.     The aim of the study is to evaluate amino acid profile in the fetus blood in different     gestational ages and compare it to post natal period.   "
250964|NCT01140724|"     In the United States alone, each year approximately 5 million children undergo painful     surgery, many of them experience serious side-effects with opioids and inadequate pain     relief. Safe and effective analgesia is an important unmet critical medical need in children     and its continued existence is an important perioperative safety and economic problem.     Inadequate pain relief and serious side effects from perioperative opioids occur frequently     in up to 50% of children. Morphine, the most commonly used perioperative opioid, has a narrow     therapeutic index and large inter-patient variations in analgesic response and serious side     effects. Frequent inter-individual variations in responses to morphine have significant     clinical and economic impact with inadequate pain relief at one end of the spectrum of     responses and serious adverse effects such as respiratory depression at the other end. Much     of the inter-individual variability in response to a dose of morphine following surgical     procedures can be explained by single nucleotide polymorphisms (SNPs) in a subset of the     genes that encode proteins involved in pain mechanisms and opioid pathway.   "
250965|NCT01140737|"     The study objective is to evaluate the therapeutic activity, safety and tolerability of     axitinib in patients with advanced/metastatic soft tissue sarcoma who are unsuitable for or     have relapsed after standard chemotherapy. The therapeutic activity will be separately     assessed in angiosarcoma, synovial sarcoma, leiomyosarcomas and other sarcomas.   "
250967|NCT01140763|"     This is a study to evaluate the incidence of sampling bias during pathologic assessment of     sentinel lymph nodes (SLN) when they are cut at a certain thickness (1 mm) and the tissue     slices are completely analyzed by histopathology (at 200 µm sections). The sponsor and     investigators would like to determine how often small cancer deposits are present in one     slice but not the other. The data will provide an empirical estimate of the incidence of     tissue sampling bias inherent in using different tissue sections for analysis. The data will     also show how varying degrees of detail in evaluating the sentinel lymph nodes (SLN) with     histopathology methods will impact the degree of agreement.   "
250968|NCT01140776|"     The study will determine the sensitivity, specificity, negative predictive value and positive     predictive value of the OSNA Breast Cancer System for patients receiving Sentinel Lymph Node     biopsies after receiving neoadjuvant hormonal/chemotherapy as compared to permanent section     Hematoxylin and Eosin (H&E) and Immuno-histochemistry (IHC) staining.   "
250969|NCT01140789|"     The aim of this study is to identify new genes in Chinese patients that help investigators to     understand the biological pathway and functions in a population in whom the incidence of     Inflammatory Bowel Disease (IBD) is increasing. And to explore the genetic variations in     Chinese patients with IBD.   "
250970|NCT01140802|"     The aim of this study is to compare the gut microbiota in Chinese patients with Inflammatory     Bowel Disease (IBD) in Hong Kong with that of healthy controls, compare the gut microbiota in     IBD patients in a developing country (low but increasing IBD incidence, Hong Kong) with those     in a developed country (high incidence, Australia), compare the gut microbiota in Chinese     patients with IBD in Hong Kong with the microbiota of their non-IBD affected parents and     siblings.   "
250971|NCT01140815|"     The objectives of this study are to assess the safety and effectiveness of the Journey Deuce     Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to     total knee replacement using the Genesis II Total Knee System. The hypothesis is that the     Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total     Knee System at the 2-year. The null hypothesis is that there is no difference between the     groups.   "
250972|NCT01140828|"     The aim of this study is to determine whether rabeprazole is superior to placebo in     preventing dyspepsia and gastroduodenal injury in subjects with osteoarthritis (OA) and/or     rheumatoid arthritis (RA) and/or bone pain.   "
250973|NCT01140841|"     The purpose of this clinical trial is to determine the maximum tolerated dose of Fipamezole     in adult patients with Parkinson's disease who are receiving levodopa.   "
250974|NCT01140854|"     While hypotension during general anesthesia has routinely been considered to be a tolerable     abnormality with little clinical consequence, the proposed study takes the innovative     approach of defining hypotensive events within the construct of a patient's own hypertensive     status, fractional mean arterial blood pressure (fMAP). Because the investigators primary     variable is within the control of anesthesia personnel, the study portends a potentially     simple and easy to implement treatment. The introduction of neuropsychometric measures as the     relevant evaluator of post-operative cognitive dysfunction is innovative, and may be more     relevant to the average elderly patient than simple mortality.   "
250975|NCT01140867|"     The object of this study is to assess the efficacy and safety of zonisamide as adjunctive     therapy in patients with uncontrolled partial epilepsy.   "
250976|NCT01140880|"     This study seeks to evaluate the efficacy of a contingency management (CM) intervention     compared to a yoked control condition for eliminating illicit stimulant use and for     decreasing time to initiating post exposure prophylaxis (PEP), for improving adherence to     PEP, and for completing PEP following a potential HIV-exposure event. Men who have sex with     men who use cocaine amphetamine or methamphetamine frequently also have high risk sexual     behaviors during or after their drug use. The objective of this study evaluates whether the     use of CM that targets stimulant use significantly aids men who have sex with men who use     stimulants and also engage in high-risk sexual transmission behaviors to be able to initiate,     adhere to and complete PEP, thereby optimizing the utility of a biomedical HIV prevention     intervention for reducing HIV incidence in this very high-risk group of MSM.   "
250977|NCT01140893|"     The purpose of this study is to determine whether exenatide is effective to improve glycemic     control among type 2 diabetic patients treated by insulin pump therapy.   "
250978|NCT01140906|"     The purpose of the study is to evaluate the efficacy, tolerability and the safety of two     fixed doses of vortioxetine in the treatment of major depressive disorder.   "
250979|NCT01140932|"     The purpose is to investigate the electroretinogram (ERG) in young, healthy men in the     normoglycaemic and hyperglycaemic state before and after intervention with corticosteroids     treatment, high calorie diet and exercise restraint.   "
250981|NCT01140958|"     Lung cancer is the No. cause of cancer death in Taiwan. Yet most of lung cancer are diagnosed     at late stage, not amenable to surgical resection. With the introduction of new targeted     agents, such as EGFR tyrosine kinase inhibitors and the identification of EGFR mutations,     lung cancer management has markedly changed in recent years. However, these new agents are     costly and their payment is restricted in certain situations defined National Insurance     Agency. Therefore, using databases from National Insurance Agency might not be able to     reflect the exact impact on pharmacoeconomics. In this study, the investigators will analyze     the data from a tertiary medical center, where all the costs including insurance     reimbursement, co-payment, and payment not covered by insurance. The investigators will also     compare with the investigators results with national database to analyze the cost benefit of     these new agents on lung cancer.   "
250982|NCT01140971|"     PURPOSE: The purpose of this study is to determine the effectiveness of balloon dilatation     (Foley) with vaginal misoprostol for cervical ripening and induction of labor.      METHOD: a randomized clinical assay has been performed with 160 women with indication of     induction of labor, randomly divided in two groups, 80 for Foley catheter and 80 for     misoprostol.   "
250983|NCT01140984|"     Post allogeneic hematopoietic stem cell transplantation (HSCT) patients with steroid     resistant acute GVHD localised to the liver will receive 24 hours continuous intra-arterial     infusion of methylprednisolone.   "
251461|NCT01147601|"     The purpose of this study is to learn about a new potential use for topical timolol 0.5%     aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study     would examine whether topical timolol could be a potential therapy.   "
250984|NCT01140997|"     This study is a multi-center, randomized, open-label and positive controlled Phase II     Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin),     once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients,     with Pegasys 180mcg/week & Ribavirin as positive control. It is aimed to establish a dose     response and safety relationship sufficient to allow the subsequent design and conduct of     Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory     requirements.   "
250985|NCT01141010|"     Pregnancy induced psychosis is an essential factor that influencing maternal health     postpartum. When gravidas, especially nulliparas, facing labor and delivery, they will     undoubtedly encounter burden from their own and surrounding facts. Maternal psychosis takes a     large part of women's psychological disorders. No matter which way, either spontaneous or     surgical, they would choose, many factors influence their psychological state. Cesarean     section poses higher risks for women than vaginal delivery. Therefore, how to seek effective     methods to alleviate parturients' psychological stress response possesses pivotal clinical     implications. Herein the investigators proposed that different linguistic interventions given     pre-, intra- or post-operatively would produce different effect on maternal psychology and     internal stress level.   "
250986|NCT01141023|"     This is a observational, multi-center study to assess progression of clinical features,     imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy     controls (HC) and in PD patient subtypes.      The primary objective of this study is to identify clinical, imaging and biologic markers of     PD progression for use in clinical trials of disease-modifying therapies.   "
250987|NCT01141036|"     Upper GI endoscopy is often performed in patients with chronic liver disease to screen for     esophageal and gastric varices. The purpose of this study is to compare propofol to midazolam     for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy.   "
250988|NCT01141049|"     Primary Hypotheses:        1. Gabapentin will significantly reduce the symptoms of alcohol withdrawal as compared to          placebo. The primary outcome measure of alcohol withdrawal will be the Clinical          Institute Withdrawal Alcohol (CIWA-Ar) (Sullivan, Sykora, Schneiderman, Naranjo, &          Sellers, 1989) score.        2. Gabapentin will significantly reduce alcohol consumption and promote abstinence as          compared to placebo. The primary outcome measure will be the number of the heavy          drinking days (defined as any day where the number of standard drinks was at least 5 for          men and at least 4 for women) per week as measured by the timeline follow-back method.      Secondary Hypotheses:      1. Gabapentin will be superior to placebo in reducing alcohol use as measured by secondary     outcomes such as amount of drinks per day, amount of drinks per drinking day, percent days     abstinent and serial measurement of gamma-glutamyl transferase (GGT) serum level.   "
250989|NCT01141062|"     This study is to collect supplementary safety and technical effectiveness data of Philips MRI     guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with     symptomatic fibroids in a 3T MRI scanner. The importance of this therapy is that it offers a     non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and     peri- menopausal women. MRI guided high intensity focused ultrasound uses ultrasound to heat     and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and     monitors heat rise in the fibroid tissue. The goal of the study is to collect supplementary     3T treatment safety and technical effectiveness data in a 1 month follow-up study. MRguided     HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of     life, and imaging endpoints will be evaluated in all study patients.   "
250990|NCT01141075|"     Methylmalonic acidemia is a rare genetic disorder caused by mutations in the gene for     mitochondrial enzyme methylmalonyl-CoA mutase (MCM) or in one of the genes for     adenosylcobalamin (AdoCbl). Lack of these proteins causes toxic elevations of methylmalonic     acid (MMacid) in blood, urine, and other tissues. A specific type of mutation, called a     nonsense (premature stop codon) mutation, is the cause of the disease in approximately 5 to     20% of patients with mutations in the MCM gene, and approximately 20 to >50% of patients with     mutations in one of the AdoCbl genes. Ataluren (PTC124) is an orally delivered,     investigational drug that acts to overcome the effects of the premature stop codon,     potentially enabling the production of functional MCM/AdoCbl. This study is a Phase 2a trial     evaluating the safety and activity of ataluren in patients with methylmalonic acidemia due to     a nonsense mutation. The main purpose of this study is to understand whether ataluren can     safely decrease MMacid levels.   "
251003|NCT01141244|"     This phase I trial studies the side effects and the best dose of temsirolimus when given     together with irinotecan hydrochloride and temozolomide in treating younger patients with     recurrent or refractory solid tumors. Temsirolimus may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus     with combination chemotherapy may kill more tumor cells.   "
250991|NCT01141088|"     The overall median survival of nonresectable malignant hilar obstruction in most series has     been less than 6 months. Most patients with malignant hilar obstruction present with advanced     disease, making allative endoscopic drainage the principal therapeutic option. However, the     optimal endoscopic management strategy is contentious. In malignant hilar obstruction,     exclusively endoscopic placement of bilateral metal stents has been considered very difficult     and complex, and it may require multiple procedures, with an increased risk of complications     and mortality. To overcome this difficulty and strategize plan of management, the     investigators evaluated the technical and clinical efficacy of endoscopic bilateral placement     of newly designed stents, Y-configuration, followed by side-by-side insertion in failure of     stent-in-stent method for the management of malignant hilar obstruction.   "
250992|NCT01141101|"     The prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) colonization and     infections have been increasing in the general population, including the pediatric     population. It has been reported that MRSA colonization persists for up to four years, and     therefore the youngest pediatric patients, specifically those who are less than 2 years of     age, have a high risk of prolonged colonization during a period of time when they are     susceptible to significant skin and soft tissue infections (SSTIs) attributable to MRSA. Once     prolonged colonization takes place, recurrent SSTIs are commonplace, resulting in substantial     morbidity and in some cases mortality, as well as a significant cost to the healthcare     system. Individuals colonized with MRSA have an increased risk of developing MRSA infections,     which range from mild disease, such as carbuncles, to severe infections, such as necrotizing     pneumonia and toxic shock syndrome. The prevalence of severe MRSA infections is also greatest     in neonates and infants, where increased MRSA colonization has been observed. In the early     infant period, the most common manifestation of MRSA disease is pustular skin lesions, which     affect approximately 5% of the general population, with MRSA-colonization being a major risk     factor for this disease. Moreover, the prevalence of pustular disease is increasing in the     general population, and there are numerous case reports of invasive, life-threatening MRSA     disease in the early infant period.      Corresponding to the increasing prevalence in the community, the carriage of MRSA in pregnant     women has also escalated, and vaginal carriage is significant in pregnant women. As an     analogy, maternal vaginal Group B Streptococcal (GBS) colonization is the major risk for     infant colonization regardless of whether early or late neonatal colonization or disease     occurs. It is quite feasible that vaginal MRSA carriage predisposes newborns to colonization     during the birthing process; however, this mechanism has not yet been well studied. There are     other mechanisms implicated for early infant colonization, including close contact with     MRSA-colonized mothers through daily care and breastfeeding. MRSA colonization in one     household member greatly predisposes colonization in others; therefore, early infant     colonization could result from contact with other MRSA-colonized individuals in a household.     Currently, it is not clear which factors are the most important in influencing early infant     MRSA colonization and subsequent infection.      Not only is the prevalence of MRSA colonization and infection on the rise, but there have     been few if any measures that have been established to prevent colonization and subsequent     infection in adults and children. Eradication measures have shown limited long-term benefit.     If vertical transmission of MRSA can be established as a critical event in the pathogenesis     of disease, potentially effective strategies could be tested, and possibly the spread of MRSA     in the community interrupted.      Hypotheses and Specific Aims:        1. Identify the proportion, rate and time of MRSA colonization in infants born to mothers          with and without MRSA colonization;        2. Compare risk factors for infant MRSA colonization in these two groups;        3. Determine the prevalence and risk factors for developing MRSA infections in the          MRSA-colonized infant.   "
250993|NCT01141114|"     This study will investigate whether patient navigation can increase rates of colorectal     cancer screening among linguistically and culturally diverse disadvantaged patients served by     urban community health centers.   "
250994|NCT01141127|"     The purpose of this study is to determine tranexamic acid plasma levels in children     undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.   "
250995|NCT01141140|"     In the face of an increased prevalence of obesity and chronic diseases in Canada, much effort     has been invested to educate the population about healthy eating. Although Canadians are now     aware of the importance of healthier food habits, rates of obesity and chronic diseases are     still increasing. In addition, even if different labelling strategies are used to identify     healthier foods in the market, consumers remain confused about what healthy eating should be.     Might describing foods as healthy have unintended side-effects on food intake? Previous     literature has shown that perceptions about the healthiness of foods may bias estimations of     caloric content of foods, leading consumers to underestimate the caloric content of healthy     food choices. Indeed, the investigators have recently shown that perceiving a food as healthy     increased intake of that food by 35% in undergraduate female students. The general objective     of the proposed research is to investigate whether food perceptions influence intake and     appetite sensations in normal-weight and overweight/obese restrained and unrestrained males     and females. This laboratory study, in which perceived healthiness and fatteningness of     oatmeal-raisin cookies will be manipulated during an ad libitum single-meal occasion, will     increase the investigators knowledge of the effects of external cues (and other psychological     and physiological factors) on the control of food intake. Because the popularity and demand     for nutrition information is increasing, such information is needed to improve clinical     practices aiming at promoting sustainable healthy eating habits to help individuals achieve     and maintain a healthy weight.   "
250996|NCT01141153|"     Objective:      The main objective is to evaluate the pattern of dual antiplatelet therapy (aspirin, 300 mg /     day + clopidogrel 75 mg / day) compared to the use of the triple regimen (Acenocoumarol as     control + acetylsalicylic acid 100 mg / day + Clopidogrel 75 mg / day) in patients with     atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2) who are undergoing PCI-S.      Design:      Randomized, parallel, with two arms, blind evaluation by third parties.      Patients:      304 patients undergoing PCI-S with atrial fibrillation, low-moderate risk of stroke (CHADS ≤     2), which requires prevention of thrombosis   "
250997|NCT01141166|"     Objective: To determine the effectiveness of an individual multifactorial intervention on     falls and undernutrition risk in very older people in the community.   "
250998|NCT01141179|"     The study will investigate the impact of reduced renal function on the pharmacokinetic and     pharmacodynamic profile of LEO 27847. Volunteers with different degrees of renal impairment     will be administered one dose of the investigational drug and then followed until     investigational drug is eliminated from the body.   "
250999|NCT01141192|"     Type 2 diabetes is more common among African Americans than Caucasians. African Americans are     also at a higher risk for lower levels of vitamin D compared to other ethnic groups. The     investigators don't yet know if there is a connection between not having enough vitamin D and     type 2 diabetes in African Americans. Researchers have found that the less vitamin D     Caucasians had the higher the chance they would have type 2 diabetes but it is less clear if     this is the case for African Americans. The investigators want to better understand how     vitamin D status and diabetes risk are linked in African Americans. Also, the investigators     want to see if supplementation with vitamin D will improve your blood pressure, blood sugar,     & insulin. All of these are in some way related to diabetes. The investigators want to     measure changes in blood sugar & blood pressure in people who do not have diabetes with the     hope of learning new information to help treat those that do have diabetes.      The investigators hypothesize that vitamin D status is related to diabetes risk measured by     hemoglobin A1c (a test of glucose level over time), fasting glucose and insulin in     non-diabetic African American adults and that body weight status may affect vitamin D status     in response to vitamin D supplements compared to placebo.   "
251000|NCT01141205|"     Treatment: Immunization with peptide-mix and adjuvant. The vaccine should induce cellular     immunity against HIV-1.      Target group: Untreated healthy individuals with chronic HIV-1 infection.      Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine.      The secondary purpose is to evaluate the clinical effect of the vaccination treatment as     measured by induction of immunity, lowering of viral load, induction of escape mutations in     the virus and improvement in the patient CD4 lymphocyte blood counts.      The third purpose is to evaluate the feasibility of conducting a therapeutic HIV immunization     study in a poorly-resourced African setting.      Design: The experiment is designed as a blinded, placebo-controlled phase 1 clinical trial in     HIV-1 infected individuals in West Africa.      Numbers of individuals: Phase I: 20 fully evaluable HIV-1-infected patients should enter the     study (15 vaccine treated and 5 placebo(saline) treated controls).   "
251001|NCT01141218|"     RATIONALE: Gathering health information about patients with non-small cell lung cancer who     never smoked cigarettes may help doctors learn more about the disease. Collecting and storing     samples of blood from patients with cancer to study in the laboratory may help doctors learn     more about cancer and identify biomarkers related to cancer.      PURPOSE: This research study is studying internet-based clinical information and blood sample     collection from patients with non-small cell lung cancer who never smoked cigarettes.   "
251004|NCT01141257|"     The purpose of this study is to determine if Angiocal® (PRS-050-PEG40) is safe and well     tolerated when it is injected into the veins of patients with solid tumors. Other purposes of     this study are to investigate how the body of the patients reacts to Angiocal®, how the blood     level of Angiocal® develops after injection and how the tumor responds to the injection of     Angiocal®.   "
251005|NCT01141270|"     Comparative pharmacokinetics study after single subcutaneous application of AFOLIA and the     reference product (Gonal-f®).      Objective: To demonstrate equivalence within the 80%-125% margin of the reference product for     the area under the curve (AUC) of AFOLIA compared to (Gonal-f®).   "
251006|NCT01141283|"     The purpose of the extension phase is to evaluate the long-term safety and tolerability of     buprenorphine transdermal system (BTDS).   "
251007|NCT01141296|"     The purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA)     and fenofibrate is more effective than UDCA alone in the treatment of primary biliary     cirrhosis.   "
251355|NCT01146184|"     The aim of this study is to improve the technique of laparoscopic cholecystectomy by using a     flexible endoscope passed through a single umbilical skin incision, as previously reported,     now with the use of Manually Articulating Devices (Ethicon Endo-Surgery, Inc.) through the     endoscope.   "
251008|NCT01141309|"     The purpose of this study is to find out what effects, good and/or bad, the combination of     sorafenib and everolimus will have on your thyroid cancer. Treatment guidelines from the     National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid     cancer. Sorafenib is pill that is approved by the FDA for the treatment of kidney and liver     cancers. Sorafenib may work in many different ways. It helps decrease the blood supply to     tumors. By doing so, it may limit the tumor's source of oxygen and nutrients and prevent the     tumor from growing. Everolimus is an oral medication that is FDA approved for the treatment     of kidney cancer. It inhibits a protein kinase called mTOR (mammalian Target of Rapamycin).     In laboratory studies, the addition of everolimus to sorafenib works better than sorafenib     alone. These two drugs are being used together to treat other types of cancer in other     clinical studies. In addition, the cancer will be evaluated to help us find factors that can     help predict who would benefit most from this combination of drugs.   "
251009|NCT01141322|"     Cholestatic drug-induced liver injury (DILI) is the severe form of DILI with a grave outcome.     Drug-metabolizing enzymes play an important role in the metabolism of drugs. The genetic     polymorphism of drug-metabolizing enzymes may influence the activities and expression of     these enzymes and thereby affect the susceptibility and severity of DILI.     UDP-glucuronosyltransferase (UGT) is an important phase 2 detoxification enzyme, which is     related to congenital hyperbilirubinemia. Recently, the genetic polymorphism of UGT1A1 was     reported to be associated with jaundice induced by some drugs, and UGT1A7 was shown to be     related to the susceptibility of hepatocellular carcinoma and other cancers. Ursodeoxycholic     acid (UDCA ) is a hydrophilic bile acid that is increasingly used for the treatment of     various cholestatic disorders. The aims of this study are (1) to assess the association of     the genetic polymorphism of UGT1A1 and 1A7, and the susceptibility and severity of     drug-induced liver injury (DILI), with emphasis on the cholestatic DILI; (2) to evaluate the     treatment effect of UDCA in the DILI, with special reference to the cholestatic     hepatotoxicity.   "
251010|NCT01141335|"     To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE     Mesh, and to compare it with the traditional Lichtenstein procedure performed with     polypropylene mesh.   "
251011|NCT01141348|"     The overall goal of the translational research is to evaluate the processes and outcomes of     implementing, in a range of public health agencies, an intense, evidence-based behavioral     weight loss intervention with demonstrated effectiveness among midlife low-income women. The     intervention was originally studied in a single coordinated community health care     center/church setting and delivered by research staff. The investigators will evaluate the     intervention's translation and test its effectiveness as implemented by existing staff in six     public health agencies supported by local community resources.   "
251012|NCT01141361|"     The purpose of this study is to assess the feasibility of home-based measurement of walking     capacity in peripheral arterial disease (PAD) patients, uing the Global Positioning System     (GPS). This study should state if the GPS technique could be used in clinical routine in     order to assess walking capacity in PAD patients. Patients will be assessed a first time     (test 1) and six months later (test 2).   "
251013|NCT01141374|"     Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and     review the auriculotherapy effectiveness through semi-permanent needles and seeds.   "
251014|NCT01141387|"     The primary objective for this study is to assess the impact of a measurement based treatment     program (MBT) on Major Depressive Disorder (MDD) remission rates in patients whose primary     care provider (PCP) receives monthly patient-reported depression severity reports compared to     patients whose PCP does not receive monthly reports.   "
251015|NCT01141400|"     The primary objective of this study is to measure the effects of patient cost-sharing on the     initiation of adjunctive treatment and subsequent healthcare utilization and expenditures     among a population of commercially insured adults on antidepressant therapy.   "
251016|NCT01141413|"     The purpose of this study is to describe infliximab and abatacept dosing patterns (i.e.,     dosing amount and frequency) and costs among a population of managed care enrollees with RA.     This study will also identify changes in infliximab and abatacept dosing over time and the     implication these changes may have on the costs of medication administration.   "
251017|NCT01141426|"     This study will use a randomized parallel group design to examine the effects of Intensive     Short-term Dynamic Psychotherapy (ISTDP) for depressed patients non-remitting following at     least one course of antidepressants. The effects of ISTDP will be judged through comparison     against secondary care treatment as usual. The aim is to establish the clinical and cost     effectiveness of ISTDP treatment.   "
251018|NCT01141439|"     The objective of the study was to compare the effectiveness, cost-effectiveness and direct     healthcare costs of managing asthma in patients with evidence of persistent asthma, following     the initiation and increased dose of inhaled corticosteroid (ICS) therapy using HFA-BDP     (Qvar®) (either as initial therapy or as a step-up therapy) compared with the most commonly     prescribed alternative ICS in the UK, CFC-beclometasone (BDP) and fluticasone (FP) as metered     dose inhalers (MDIs). Qvar vs FP analyses were split between adults (12-60yrs) and     paediatrics (5-11yrs).   "
251291|NCT01145313|"     The primary objective is to examine changes in pre/post-augmentation healthcare costs and     resource utilization in patients diagnosed with major depressive disorder (MDD) who augment     their current antidepressant therapy with an atypical antipsychotic.   "
251019|NCT01141452|"     The objective of this study is to compare the effectiveness, cost-effectiveness and direct     healthcare costs of managing chronic obstructive pulmonary disease (COPD) in primary care     patients with evidence of COPD who either initiate inhaled corticosteroid (ICS) therapy, or     have an increase in their ICS dose, as hydrofluoroalkane (HFA) beclometasone dipropionate     (BDP) (hereafter Qvar®), CFC-BDP (hereafter BDP) and fluticasone propionate (FP) via     pressurised metered-dose inhalers.   "
251091|NCT01142401|"     This phase II trial is studying giving fulvestrant and bortezomib together to see how well     they work compared to fulvestrant alone in treating postmenopausal women with locally     advanced or metastatic breast cancer. Estrogen can cause the growth of breast cancer cells.     Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen     the body makes. Bortezomib may stop the growth of breast cancer cells by blocking some of the     enzymes needed for cell growth or by blocking blood flow to the tumor. It is not yet known     whether fulvestrant is more effective with or without bortezomib in treating breast cancer.   "
251020|NCT01141465|"     This study will evaluate and compare the effectiveness of asthma management in patients with     evidence of persistent asthma following a switch in asthma therapy to combination inhaled     glucocorticosteroid (ICS) / long-acting bronchodilator (LABA) therapy as either:     fixed-combination fluticasone propionate / salmeterol (FP/SAL; Seretide®) via pressurised     metered-dose inhaler (pMDI) or dry-powder inhaler (DPI) plus as-needed (prn) reliever therapy     (salbutamol as DPI, BAI or pMDI), or fixed-combination budesonide / formoterol (BUD/FOR;     Symbicort®) via DPI plus prn reliever therapy (salbutamol as DPI, BAI or pMDI or bricanyl as     DPI). The final analysis plan will define exact comparators and age groups to be studied     after reviewing baseline data.   "
251021|NCT01141478|"     This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared     to Sorafenib alone will produce the best results for treating patients with Hepatocellular     Carcinoma.   "
251022|NCT01141491|"     Sarcoma patients are at high risk for their cancer to recur even when the sarcoma has been     removed surgically or treated with radiation or chemotherapy. The patients in the study will     be randomized (like flipping a coin) to receive either a vaccine that is combined with an     immune system stimulant or the immune system stimulant alone. The immune system stimulant is     called OPT-821 and is an immunological booster. The trivalent vaccine is being developed to     teach the patient's immune system to recognize 3 types of sugars called GM2, GD2 and GD3 that     are found primarily on the surface of sarcoma cells. If the trivalent vaccine can stimulate     the patient's immune system to develop antibodies which recognize and target the GM2, GD2 and     GM3 sugars, then the patient's antibodies could attack and kill any remaining sarcoma cells     potentially preventing the recurrence of sarcoma.   "
251023|NCT01141504|"     Adenosine-triphosphate (ATP) serves as the sole energy source for muscle contraction.     Therefore human performance of brief maximal exercise is limited, in part, by the     availability of ATP to the contracting muscle. Because muscle ATP storage is small (enough to     sustain maximal exercise for less than 1 second), factors that enhance either storage or     resynthesis of ATP may have a positive impact on repeated muscle contractions. The current     study will test the hypothesis that increasing ATP availability to muscle via oral     supplementation will improve performance of repeated high intensity exercise as measured by     a) work performed in each of the three 50 contraction fatigue tests, b) sum of total work     performed, and c) percentage decrement in total work from the first to third third 50     contraction test.   "
251024|NCT01141517|"     The primary objective of this research is to explore relations between impulsive behavior and     smoking-cessation success among treatment-seeking teens enrolled in a quit-smoking program.      It is hypothesized that teens who do not successfully stop smoking (or who drop out of the     treatment program) will be more impulsive (from measures taken just prior to treatment) than     those who do successfully stop or significantly reduce rate of smoking.   "
251025|NCT01141530|"     This project is a pilot study designed to investigate transcriptional regulation in breast     cancer. Although the main focus of the present study will be triple negative breast cancer     where all of the clinically relevant receptors - estrogen receptor (ER), progesterone     receptor (PR) and herceptin (HER2) - are absent, all breast tissue biospecimens, including     normal and mammary dysplasia, stored in the UAMS Tissue bank, procured from outside     collaborators or purchased from commercial vendors will eventually be investigated. We will     use high throughput molecular profiling techniques such as microarrays and next generation     sequencing to correlate gene expression and gene expression regulation with clinical     parameters such as tumor size, time to relapse and overall survival.   "
251026|NCT01141543|"     The study will be conducted as a single center Phase I/II study to evaluate the safety of     administering Plerixafor administered as part of a myeloablative preparative regimen     (Institutional Protocol:Fludarabine 50mg/m2/da x 4 days, Busulfan 3.2mg/kg/day x 4 days, TBI     400cGy in divided fractions) for stem cell transplant recipients with AML and to determine     whether or not residual leukemic stem cells can be mobilized. Three patients will be enrolled     into each of 4 sequential cohorts. Patients in the first cohort will receive 1 dose of     Plerixafor (240mcg/kg sc) prior to administration of the first dose of Fludarabine and     Busulfan. If tolerated it is planned to escalate the number of Plerixafor doses in the     subsequent cohorts to 2. 3. and 4 to be administered before the respective 2nd, 3rd, and 4th     dose of chemotherapy.   "
251027|NCT01141556|"     Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are     involved in the inflammatory response regulation. The degree of selenium deficiency     correlates with disease severity and the incidence of mortality in critically ill patients.     The aim of our study is to evaluate, if high dosis selenium supplementation (loading dose     4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced     organ dysfunction and length of ICU-stay in patients after heart surgery.   "
251028|NCT01141569|"     The purpose of this study is to evaluate the activity of RO4929097 in renal cell carcinoma     patients that have failed therapy with VEGF/VEGFR directed agents.   "
251029|NCT01141595|"     The purpose of this study is to develop biomarkers for central nervous system BH4     concentration in children with autism so they can be easily screened to determine if they may     benefit from BH4 supplementation. Kuvan is a synthetic form of BH4. BH4 is an enzyme cofactor     that is essential for several critical metabolic functions.   "
251030|NCT01141608|"     The purpose of this study is to investigate if health interventions (intensive exercise or     health education) can be used to help improve substance abuse treatment. The primary     objective of this protocol is to compare percent days of abstinence between Vigorous     Intensity High Dose exercise (VIHD) and Health Education Intervention (HEI) groups based on     stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding     caffeine and nicotine) use during a 12-week acute phase.   "
251031|NCT01141621|"     The purpose of this study is to        1. better characterize the short term and long term natural history of hereditary          spherocytosis (HS) including diagnosis, complications, and indications for and response          to splenectomy        2. evaluate and describe the health-related quality of life in children with HS.   "
251281|NCT01145183|"     Doxazosin, an alpha 1-adrenergic receptor antagonist, may play an important role in cocaine     addiction in humans. This study will evaluate to what extent the prospective screening for     catecholamine related polymorphisms for alpha 1 NE receptor/transporter, COMT and DBH as main     targets predict the treatment efficacy of doxazosin for cocaine-using behavior.   "
251032|NCT01141634|"     Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that presents     during childhood, and is characterized by developmentally inappropriate levels of inattention     and/or hyperactive-impulsive behavior. It is proposed that classical homeopathic treatment     can reduce the symptoms of ADHD without serious side effects. This is an open label pilot     feasibility study (36 participants). Participants, age 6-16, will consult with a homeopathic     practitioner who will select treatments based on classical homeopathy principles. All     participants will be assessed on a 4-weekly basis for a total of 36 weeks. The purpose of the     study is to assess feasibility of recruitment and patient retention, to obtain pilot data on     which to base a sample size calculation for future study, and to identify major safety     concerns. The study will use single homeopathic medicines approved for over-the-counter use     in Canada. The primary outcome measure will be the validated Conners 3rd Edition - Parent.   "
251033|NCT01141647|"     This study will be an extension of the Spinal Cord Injury Vocational Integration Program     (SCI-VIP). The study involves research about how to help Veterans with spinal cord injury     (SCI) gain employment. Vocational rehabilitation is a special field of service aimed at     putting persons with disabilities in the best possible position to become employed. The     Veterans Administration has a long history of providing vocational rehabilitation for     Veterans with mental health issues and has recently started providing similar services to     persons with physical disabilities, including SCI. Past research has shown that vocational     rehabilitation is effective in helping some Veterans with spinal cord injury (SCI) gain     employment. The extension of this work through PrOMOTE study will establish a large national     database of over 2000 Veterans with SCI, containing extensive employment, medical, functional     and psychosocial data. The study will analyze both quantitative and qualitative measures to     maximize its findings.   "
251034|NCT01141660|"     The aim of the current study is to compare the use of laryngeal mask airway (LMA) and     endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess     the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also     sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We     hypothesized that the LMA would be a safe efficient alternative to the ETT.   "
251035|NCT01141673|"     FLT3 overexpression in acute myeloid leukemia (AML) is often caused by mutations in this     gene. These mutations cause constitutive phosphorylation of FLT3 proteins leading to     increased proliferation and survival, decreased apoptosis and resistance to chemotherapeutic     agents in AML cells. There are two major types of FLT3 mutations- internal tandem duplication     (ITD) and point mutation at 835th amino residue. AMLs with FLT3 mutations have worse     prognosis and are often resistant to conventional chemotherapy. Several small molecule     compounds targeting FLT3 have been in the market or in clinical trials. Therefore,     identification of these mutations at the time of diagnosis will provide a better prognostic     prediction, might guide the treatment selection and follow-up strategies. In this study, the     investigators will develop a sensitive molecular assay to detect FLT3 mutations for future     clinical application. The investigators will collect 100 AML samples with at least 20 samples     with known FLT3 mutations. The investigators will compare this assay with commonly used     methods and standardize the procedure to meet the requirement of clinical pathology     laboratory with reasonable cost.   "
251036|NCT01141686|"     Evaluate chemotherapy related tumor markers on non small cell lung cancer by fluorescent in     situ hybridization and immunohistochemistry, targets to be studied include EGFR, c-MET,     topoisomerase II, p53, topoisomerase I, thymidylate synthase, ERCC1, tau, c-myc, RRM1, class     III tubulin. These targets have been chosen because they are targets for chemotherapeutic     agents that are currently used in clinical management of these diseases. In total 50 specimen     will be studied, approximately one third have mutations/deletions of the EGFR gene.To attempt     to establish a correlation between the pre-selected tumor markers and response to     chemotherapy, and thus to be able to create a clinically useful classification that would     provide clinical guidance for selection of the most effective chemotherapy for a individual     patient, and thus be able to logically design more effective clinical trials for the future.   "
251037|NCT01141699|"     There were a breast cancer screening activity in Taipei Medical University-Shuang Ho     Hospital. We did an intervention with woman who joined the activity.The most important part     in the intervention was to know health behavior about the breast cancer prevention.By doing     the study, the investigators will know how to promote the health activity in our community.   "
251038|NCT01141712|"     This study is a Phase II, multicenter trial assessing overall survival after autologous     hematopoietic stem cell transplantation using a BEAM transplant regimen (carmustine,     etoposide, cytarabine, melphalan) in lymphoma patients with HIV.   "
251039|NCT01141725|"     This phase I/II trial is studying the side effects and best dose of bendamustine     hydrochloride when given together with idarubicin in treating older patients with previously     untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Drugs used in     chemotherapy, such as bendamustine hydrochloride or idarubicin, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells   "
251050|NCT01141868|"     This study examines the efficacy of an Internet-delivered intervention to reduce symptoms of     insomnia in breast cancer survivors. Breast cancer patients with insomnia (N=30) will be     assigned to either gain access to the 6-week treatment program immediately (experimental     group) or following study participation (control group).   "
251051|NCT01141881|"     Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen     activator(tPA) in treatment of refractory diabetic macular edema(DME).   "
251052|NCT01141894|"     The investigators aimed to compare the costs and consequences of 'routine perioperative fluid     therapy' and 'GDHT in terms of morbidity, mortality, length of hospital stay, activity of     daily living, health related quality of life, cognitive functions and need of social services     and up till 12 months following operations of proximal femoral fracture at elderly. The     primary hypothesis is that 'GDHT is a better strategy than 'routine fluid therapy' in terms     of reduced frequency of postoperative complications.   "
251356|NCT01146197|"     Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain     some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts     are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to     cardiac and muscles symptoms.   "
251040|NCT01141738|"     Intervention studies for stroke caregivers (CG's) during early caregiving are few and have     met with limited success. The Post-Stroke Rehabilitation Clinical Practice Guidelines (1995)     recommend sensitivity to the adverse effects of caregiving on family functioning and CG     health. Breakdown of the informal care system can lead to premature introduction of formal     services, excess disability, and decline in well-being for stroke survivor and CG alike.     Thus, it is important to attempt to prevent the chronic distress of stroke CGs through an     early intervention that prevents and remediates distress, coaches problem-solving and other     coping skills, can affect multiple outcomes, has durable effects, and is non-threatening and     accessible. The proposed intervention will incorporate these features and will be low cost     and feasible for use in clinical practice; it will target outcomes important to stroke CGs,     depression, anxiety, caregiver preparedness, perceptions of life changes, family functioning,     and survivor functioning. The individual format will make it possible to address life stage     needs and cultural issues. Given the prevalence of distress in chronic stroke CGs, early     intervention to prevent and mediate negative outcomes is essential.   "
251041|NCT01141751|"     Significant data from placebo-controlled clinical trials have demonstrated the efficacy of     Rebif in relapsing remitting multiple sclerosis (RRMS) with reduction in relapse rate, delay     in disability progression, and reduction in magnetic resonance imaging (MRI) activity and     accumulation of lesion burden. Multiple sclerosis (MS), a chronic neurological diseases, can     have diverse effects on the lives of subjects and their families. In controlled clinical     trials, clinical measurement in MS has focused on impairments of neurological assessment     using Expanded Disability Status Score (EDSS). The assessment of the impact of MS on the     non-physical aspect of dysfunction is not often measured, or reported. Furthermore,     traditional clinical measures have not been able to assess the effects of neurological     illness on quality of life (QoL), which is becoming an increasingly important topic to     neurologists treating subjects with varied neurological conditions.      This observational, one arm, multicentric study is aimed to assess the usefulness of the     Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) instrument in     comparison with the Multiple Sclerosis Quality of Life-54 instrument (MSQOL-54 questionnaire)     in RMS subjects on Rebif therapy and to assess the effectiveness of Rebif therapy using     health related quality of life (HRQoL) measures.   "
251042|NCT01141764|"     The purpose of this research study is to evaluate the brain circuits function and circuits     involved in the mechanism of thalamic DBS in patients with medically refractory epilepsy.   "
251043|NCT01141777|"     Spirulina, a widely used food supplement, improves the lipid profile and glycemic control in     people living with diabetes, suggesting that it could have some effects on insulin     sensitivity. Since HIV-infected patients develop metabolic abnormalities due to the virus     and/or to antiretroviral (ARV) drugs, the investigators therefore proposed to evaluate the     effect that spirulina can have on HIV/HAART-associated insulin resistance   "
251044|NCT01141790|"     Objectives: (1) To check music or voice message influence on vital signs, facial expressions     or muscular tonus of coma, vegetative or sedated patients; (2) To connect the existence of     patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale; (3)To     evaluate the relation between the response and the score of Glasgow Outcome Scale.   "
251045|NCT01141803|"     The investigators will assess the protective and antiinflammatory effects of processed fruit     and fruit fibre in overweight subjects with signs of metabolic syndrome. A single-blinded     parallel study is conducted to investigate the protective effects of fruit fibre on colonic     epithelium. Relevant signalling pathways related to cholesterol metabolism, vascular     inflammation, oxidative defence, apoptosis and sterol metabolism will be targeted. Volunteers     are randomly assigned one of three groups. They are instructed to follow a polyphenol and     pectin restricted diet for six weeks. The last four weeks in this six week period, the     restricted diet is supplemented with whole apples (550g/day), apple pomace (22g/day) or     nothing. Blood, urine, faecal samples and colon biopsies are collected before and after the     four weeks intervention period.   "
251046|NCT01141816|"     Radiofrequency ablation (RFA) is an increasingly popular therapy option for treating small     kidney cancer, especially for patients who are not ideal candidates for traditional surgery.     Currently, follow-up after this procedure involves the patient having several CT scans (or     MRI scans in some cases) over time to monitor for possible cancer recurrence. However, there     are risks associated with the radiation exposure from CT scans and other risks, such as     adverse events from the contrast media used in these scans. This study will therefore     investigate whether a different technique, contrast-enhanced ultrasound (CEUS), can be an     effective tool for follow-up monitoring of kidney cancer patients who have undergone RFA by     comparing the results of their standard follow-up CT scans (or MRIs if applicable) with the     results of CEUS. If CEUS is found to be just as effective as CT scans or MRIs in detecting     kidney cancer recurrence, this technique could potentially become the new standard of care     for follow-up.   "
251047|NCT01141829|"     Obstructive Sleep Apnea (OSA) is associated with increased oxidative stress. The major     sources of Reactive Oxygen Species (ROS) in the vasculature are the NADPH oxidases. Several     polymorphisms related to NADPH oxidase expression or NADPH oxidase activity has been     identified. The investigators are going to compare the distribution of the allelic     frequencies of A-930G and C242T polymorphisms and their possible relationship with the levels     of 8-isoprostanes as a marker of oxidative stress in patients with OSA and in a control group     without OSA.   "
251048|NCT01141842|"     Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled     breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer     dogs are trained to distinguish between the BS of patients with lung cancer and healthy     individuals (controls). In a prospective, randomized blinded study the dog's ability to     differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory     airway disease, but no evidence of cancer and iii) healthy individuals is tested.   "
251049|NCT01141855|"     The Smoking Termination Opportunity for inPatients, (STOP) project is designed to capture the     opportunity that is provided by admission for acute smoking related illness, to assist     patients through withdrawal by use of a combination of:        -  the new medication Champix with        -  best practice counselling        -  initiated in an inpatient setting      to achieve:        -  sustained smoking abstinence        -  reduced hospital bed and health service utilisation        -  reduced inpatient smoking and craving prior to discharge   "
251053|NCT01141907|"     Heart failure (HF) affects over 5 million Americans with HF morbidity reaching epidemic     proportions. Annual rates of new and recurrent HF events including hospitalization and     mortality are higher among African Americans. In this study, the investigators are testing an     interdisciplinary model for heart failure care, with focus on enhancing self management and     use of telehealth, which has significant potential to improve self management and outcomes.      The main purpose of this study is to learn how to help African Americans with heart failure     care for themselves at home. We hope to find out if a team including a nurse and community     health navigator using a computer telehealth device can help people with heart failure stay     healthier. The team will help people with heart failure to manage their medication, monitor     their symptoms and weigh themselves every day after they leave the hospital. The team will     also help people with heart failure learn to solve problems that may keep them from following     their treatment plan.   "
251054|NCT01141920|"     New admissions (n = 120) to the Addiction Treatment Services (ATS) will be stabilized on     methadone and randomly assigned to one of two induction conditions: 1) routine stepped care,     or 2) low threshold stepped care. All participants will continue with routine stepped care in     month 4. Treatment retention is the primary outcome measure, while drug use (measured via     weekly urinalysis testing) is the major secondary outcome.   "
251055|NCT01141933|"     The purpose of this study is to test the efficacy of a cognitive-existential intervention     (using either an individual or a group format) to improve the existential and global quality     of life of patients as compared to usual care in a population of adult non-metastatic cancer     patients.   "
251056|NCT01141946|"     Lung cancer remains the leading cause of mortality from malignant diseases in both men and     women worldwide. Accurate diagnosis, staging and therapeutic targeting of lung cancer and     other pulmonary pathology are vital with regards to providing patients with expedient and     accurate treatment and treatment plans. The pre-operative evaluation and consultation in     patients who are to undergo operative staging or resection for lung cancer is     multidimensional and involves detailed history taking, physical examination and review of     imaging studies. Two important elements of both staging and pre-operative evaluation include     the evaluation of: (1) the pleural space for malignant pleural effusion and (2) the diaphragm     for appropriate movement. At this point in time, the pleural space evaluation is being     performed using CT scan which does not allow the acquisition of real-time cytological     material from pleural effusions due to the fact that the CT scans are done in a diagnostic     setting. Diaphragmatic movement/excursion is not currently being assessed pre-operatively and     its impact on staging and post-operative pulmonary function is unknown.      Malignant pleural effusion is recognized as a poor prognosticator in non-small cell lung     cancer patients and has recently been upgraded from a T4 to an M1a status in the new edition     of the AJCC NSCLC Staging System (7th Edition). The appreciation of the poor prognosis     related to malignant effusion has upgraded the stage from a Stage IIIb to a stage IV.     Recognizing the stage early allows for more precise prognostication of disease and can lead     to precision and streamlining of treatment plans for thoracic surgeons and oncologists.   "
251057|NCT01141959|"     The investigators are interested in identifying patient-specific factors related to donor     chimerism in patients who receive nonmyeloablative hematopoietic stem cell transplants from     haploidentical donors. We will look how patients' bodies break down and immediately respond     to cyclophosphamide, fludarabine and mycophenolate mofetil.   "
251058|NCT01141972|"     Specific Aim 1: To compare effects of Vitamin D supplementation to usual care on symptoms in     women transitioning to early postmenopause and determine the associated effect size in order     to conduct a power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in     early postmenopause who are randomized to supplementation, titrated to achieve sufficiency     for 2 months, will have fewer symptoms including hot flashes, mood, and musculoskeletal     complaints than women randomized to usual care.      Specific Aim 2: To compare effects of Vitamin D supplementation to usual care on body     composition (by dual-energy x-ray absorptiometry [DXA] and by weight, BMI, waist to hip     ratio) in overweight/obese women transitioning to early postmenopause and determine the     associated effect size for a power analysis for a future RCT. Hypothesis: Vitamin D     insufficient women in the menopausal transition randomized to supplementation, titrated to     achieve sufficiency for 9 months, will improve DXA body composition (less total body and     abdominal fat), compared to women in usual care, who will have increased body weight,     including total and abdominal fat.      Specific Aim 3: To estimate the proportion of overweight/obese middle-aged women who achieve     sufficiency by 1 month versus 2 or more months and to determine if achieving sufficiency by 1     month varies by baseline characteristics. Hypothesis: About 80% of participants will achieve     sufficient Vitamin D level by 1 month. Those who need more than 1 month for sufficiency will     have lower baseline levels and higher initial BMI.   "
251059|NCT01141985|"     The objective of this study is to evaluate the ease of use of a modified, disposable contact     lens and suction ring assembly.   "
251060|NCT01141998|"     Purpose:      The overall objective of this study is to learn more about the disease chronic pancreatitis     and thus contribute to better treatments. The investigators will gain this by studying the     effects of vitamin D in the body immune system and bones. The investigators will also study     the uptake of vitamin D through the intestine compared with the amount of vitamin D obtained     through exposure to UVB rays.      The investigators have set a series of questions which the investigators want to answer with     this experiment:      Do patients with chronic pancreatitis have reduced absorption of vitamin D from the gut?        -  Have the two treatment methods with vitamin D, UV radiation and tablets, the same          success rate?        -  Does the distribution of the white blood cells change when the vitamin D level increases          and does it depend on whether the patient have UVB radiation or tablet with vitamin D?        -  Will patients require reduced amounts of painkillers when vitamin D level increases?        -  Does vitamin D have influence on blood sugar and thus the risk of diabetes or worsening          of this?        -  Could vitamin D affect the blood content of inflammation markers?        -  Does the patient feel better when he takes vitamin D?        -  Does bone strength increase when the patients receive grants of vitamin D?   "
251061|NCT01142011|"     Hypothesis; That inhibition of plasma Blys by the monoclonal antibody Belimumab will reduce     both the survival of the lymphoplasmacytoid cells of Waldenstrom Macroglobulinaemia (WM), and     their production of monoclonal IgM, resulting in a reduction of IgM paraprotein.   "
251062|NCT01142024|"     With the wide use of contrast agents in clinical diagnosis and treatment, contrast induced     nephropathy(CIN) accounts for 1/3 of hospital acquired acute renal failure.The mortality rate     of patients with CIN is up to 35%,and about 30% patients with permanent renal     dysfunction.Prevention and treatment of this iatrogenic complication and reducing morbidity     has become an urgent task to every medical worker.      Now the pathogenesis of CIN is not clear,while the toxicity of renal tubular epithelial cell     and the hypoxia of renal medullary is likely to be the main mechanism of CIN.Iodine contrast     agent concentrate in the tubular and collecting duct and directly damage cells,leading to     tubular cell death;also induce the release of renal vasoconstrictors,such as adenosine,     endothelin, causing acute vasoconstriction.Furthermore,oxidative stress and the inflammatory     response induced by ischemia may worsen kidney function.      Thus a large number of studies focus on oxidative stress in the pathogenesis of     CIN.Recently,some studies have shown that oxidative stress proteins play an important role in     acute renal injury(AKI),and have reported that these proteins of different genotypes related     to the incidence and prognosis of AKI.      Therefore,the investigators speculate whether some patients have genetic potential of     increased oxidative stress,and are more prone to contrast induced nephropathy? At     present,there are a great number of researches about preventive measures of CIN.The firstly     and widely used therapy is hydration.But it just dilutes iodine contrast medium in renal     tubular and collecting duct,increases urine output to prevent the formation of tubular     crystals.According to the pathogenesis of CIN,oxidative stress plays an important role in     CIN,thereby several antioxidants,such as N-acetyl cysteine or Glutathione are also under     study.But results are inconsistent.      As a result,the investigators designed this study to evaluate the oxidative stress in     cardiovascular population on the impact of contrast medium nephropathy,and the relationship     in antioxidant enzymes with genetic polymorphisms,to find clinical indicators predicting     renal dysfunction and guiding individual treatment to prevent its occurrence.   "
251063|NCT01142037|"     Certain plant foods are high in furanocoumarins. Test tube and animal studies suggest that     furanocoumarins may help prevent cancer. It is difficult to determine in humans if     furanocoumarins do prevent cancer because there isn't an objective way to tell who has eaten     these compounds. This study will develop a urine test to determine if an individual ate foods     that contain furanocoumarins.   "
251064|NCT01142050|"     The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin     Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.   "
251065|NCT01142063|"     The purpose of the study is to demonstrate the bioequivalence of the proposed commercial     neratinib tablet formulation (240 mg strength x 1) to the reference Phase 3 tablet     formulation (40 mg tablet strength x 6) under fed and fasted conditions in healthy subjects.   "
251066|NCT01142076|"     Xinju Xiaogao prescription and 10% of it in the treatment of adiposity (stagnation of QI     causing phlegm retention)clinical study   "
251067|NCT01142089|"     The purpose of this study is to determine whether Rifamycin SV MMX is a safe and effective     treatment for Traveler's Diarrhea.   "
251068|NCT01142102|"     The principal objective of the trial is to test the hypothesis that Online Adaptive     Radiotherapy for Muscle Invasive Bladder Cancer is feasible across multiple Radiation     Oncology departments.   "
251069|NCT01142115|"     The purpose of this study is to evaluate the safety of a new developed catheter in comparison     with an catheter on the market. The study is randomised.   "
251070|NCT01142128|"     Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic     abdominal pain in patients with small duct chronic pancreatitis in a superior fashion     compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an     increase in quality of life. Our objective is to elucidate the role of Nexium in the control     of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16.     Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased     ER visits and decreased hospital admissions for abdominal pain.   "
251071|NCT01142141|"     To evaluate the effectiveness of manual therapy (joint mobilization and massage) combined     with kinesiotherapy in women with impaired range of motion after axillary lymph node     dissection due to breast cancer regarding the recovery of shoulder range of motion and     functionality of the upper limb.   "
251072|NCT01142154|"     This study is to compare the exposure of orally administered Prodarsan to the intravenous     dosed Osmitrol (10% solution) in Cockayne Syndrome (CS) patients. Also the pharmacokinetics     of single and multiple orally dosed Prodarsan will be evaluated and compared to intravenous     dose of Osmitrol in CS patients.   "
251073|NCT01142167|"     The aim of the study is to study the caecal intubation rate of a prototype ultra-thin     colonoscope compared to a standard colonoscope and to study usefulness of this new     colonoscope as a rescue instrument for failed initial colonoscopy with a standard colonoscope     and to study the patient satisfaction scores using a validated endoscopy GHAA-9 for a new     prototype colonoscope as compared to a standard colonoscope.   "
251074|NCT01142180|"     The aim of this study is to determine if early angiographic embolization can forestall     recurrent bleeding in selected high risk ulcers after their initial endoscopic control; to     validate prospectively the investigators proposed in selecting high risk ulcers for recurrent     bleeding in spite of maximal endoscopic control and profound acid suppression using high dose     intravenous infusion of proton pump inhibitor; to characterize the nature of bleeding     arteries in severely bleeding peptic ulcers and determine the efficacy of angiographic     embolization in the prevention of recurrent bleeding and to establish safety profile of     angiographic embolization as an early elective treatment to bleeding peptic ulcers.   "
251075|NCT01142193|"     The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive     therapy in patients with refractory partial onset-seizures.   "
251076|NCT01142206|"     The purpose of this investigation is to conduct an 8-week pilot study to examine the effects     of two different leisure-time activity prescriptions on dietary intake, leisure-time     activities, and weight loss in 30 adults receiving an 8-week behavioral weight loss     intervention.   "
251077|NCT01142219|"     One of the main problems in sickle cell disease is the decreased bioavailability of nitric     oxide and arginine. This study was designed to assess if treating sickle cell disease     patients with L-arginine would improve pulmonary arterial pressure and other aspects.   "
251078|NCT01142232|"     This is a research study for newly diagnosed multiple myeloma or multiple myeloma has     returned (relapsed). Multiple myeloma is a type of cancer that begins in white blood cells     called plasma cells. Plasma cells make proteins that help fight infections. Current therapy     for multiple myeloma includes high dose chemotherapy and autologous (patient's own cells)     stem cell transplantation.      There will be two parts (or phases) to this study:      The purpose of the first part is to find the highest dose of a drug called lenalidomide     (Revlimid®) that can be given in combination with high dose melphalan without causing severe     adverse events.      The purpose of the second part is to find out the effects of this treatment (good and bad) on     multiple myeloma patients.   "
251079|NCT01142245|"     The investigators previously showed that the use of a high-dose intravenous PPI regimen after     endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding,     decreased the need for endoscopic and surgical interventions and in general improved     patients' outcomes. A trend towards reduced mortality associated with the use of high-dose     intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence     that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis     suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce     rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to     oral PPI in this patient population.      The purpose of this clinical study is to compare the efficacy and safety of intravenous and     oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent     bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.   "
251080|NCT01142258|"     The purpose of this study is to determine whether trazodone is effective in the treatment of     sleep disorders in Alzheimer's disease (AD).   "
251081|NCT01142271|"     The purpose of this trial is to compare the degree of reflux, operative outcomes and quality     of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy     for gastric cancer   "
251082|NCT01142284|"     Based upon evidence of efficacy and safety of both cilostazol and probucol administration in     independent randomized controlled trials in PAD and CAD, the present trial seeks to     investigate the effect of concomitant administration of cilostazol and probucol on FMD     compared to each drug individually, as well as to evaluate biomarker measures and safety     indices in this context.   "
251083|NCT01142297|"     This study compares the patterns of dental implant stabilization between a standard and     chemically modified implant surface in patients with type 2 diabetes. It is hypothesized that     the chemically modified surface will enhance early healing events (first 4 months following     placement)in diabetes patients with compromises in rate of implant integration.   "
251084|NCT01142310|"     Stress and corticosteroid exposure are associated with changes in both the human and animal     hippocampus. An extensive literature suggests that corticosteroid-induced changes in the     hippocampus are, in part, mediated through increases in extracellular glutamate. In animals,     agents that decrease glutamate release prevent dendritic changes in the hippocampus secondary     to stress or corticosterone. We have developed a research program using patients receiving     prescription corticosteroids (e.g., prednisone) to explore the effects of corticosteroids on     the human hippocampus. Our research program is translational in focus, with a goal of     exploring whether the reported effects of corticosteroids on the animal hippocampus are also     found in humans. A current focus of our research is examining glutamate release inhibitors in     patients taking corticosteroids. We have both open-label and placebo-controlled pilot data     suggesting that the glutamate release inhibitor lamotrigine is associated with significant     improvement in declarative memory (a measure of hippocampal performance) in this population.     A definitive study examining declarative memory in corticosteroid-dependent patients     receiving lamotrigine vs. placebo is proposed. Neuroimaging and mood will also be assessed.   "
251085|NCT01142323|"     The purpose of this study is to determine whether fenofibrate is safe and effective in the     treatment primary sclerosing cholangitis (PSC).   "
251086|NCT01142336|"     A year-long randomized, double-blind, placebo-controlled trial of simvastatin to see if it     produces beneficial changes in cerebral spinal fluid proteins associated with Alzheimer's     disease.   "
251087|NCT01142349|"     This study compares the efficacy of three group interventions for people with co-morbid     osteoarthritis (OA) and insomnia to help them manage their OA symptoms. The investigators     hypothesize that a combination cognitive-behavioral treatment will produce significantly     greater initial and long-term improvements in OA symptoms than will the other two treatments.   "
251088|NCT01142362|"     DNA vaccines consist of small pieces of DNA also known as plasmids, and have several     potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well     tolerated in humans. The investigators have developed a DNA vaccine, VGX-3400X, which     includes plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will     be delivered via electroporation (EP) which uses the CELLECTRA constant current device to     deliver a small electric charge following injection, since animal studies have shown that     this delivery method increases the immune response to vaccine. The vaccine will be given to     30 healthy adult subjects. It is hypothesized that VGX-3400X + EP will be well tolerated and     immunogenic.   "
251089|NCT01142375|"     Acute leukemias are commonly seen in elderly and have no effective therapy. In recent years,     small molecule inhibitors have shown a tremendous promise in cancer treatment such as chronic     myeloid leukemia and lung cancer. Thus, in this proposal, we intend to use our novel patented     indole compound to conjugated with hydroxamic acid in histone deacetylases inhibitor,     suberoylanilide hydroxamic acid and further modify its structure to generate novel     small-molecule anticancer compounds. By screening acute leukemic cell lines, we will look for     compounds that have shown potential for future drug development. In our preliminary studies,     we have identified a novel compound, MPT0E001, to have marked growth inhibitory activity,     induce apoptosis and downregulate c-Myc protein level. We intend to use MPT0E001 as a basis     to develop novel compounds and test them in multiple leukemic cell lines and primary leukemia     samples (Specific aim 1) and identify the mechanisms for downregulation of c-Myc and other     pathways such as NF-kappaB and Akt (Specific aim 2). Once we have identified the lead     compounds, we will use murine model to assess the acute toxicity profiles in different dose     ranges and examine the effects of blood counts and vital organs. After toxicity study, we     will test the lead compounds using in vivo xenogenic murine model using both cell lines and     primary leukemia. Using this approach, we hope to develop novel compounds that are able to be     used in future leukemic therapy.   "
251090|NCT01142388|"     This randomized phase II trial studies how well paclitaxel with or without cixutumumab works     in treating patients with esophageal cancer or gastroesophageal junction cancer that has     spread to other places in the body (metastatic). Drugs used in chemotherapy, such as     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Cixutumumab may     kill cancer cells by blocking the action of a protein needed for cancer cell growth. Giving     paclitaxel with or without cixutumumab may kill more tumor cells.   "
251092|NCT01142414|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more     tumor cells and cause less damage to normal tissue. Monoclonal antibodies, such as     panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. It is not yet known whether chemotherapy given together with radiation     therapy is more effective with or without panitumumab in treating patients with advanced     cancer of the hypopharynx, oropharynx, larynx, or oral cavity.      PURPOSE: This randomized phase III trial is studying chemotherapy given together with     radiation therapy to see how well it works compared with chemotherapy and radiation therapy     given together with panitumumab in treating patients who have undergone surgery for advanced     hypopharyngeal cancer, oropharyngeal cancer, laryngeal cancer, or oral cavity cancer at high     risk of recurrence.   "
251093|NCT01142427|"     This research trial studies a risk-based classification system for patients with newly     diagnosed acute lymphoblastic leukemia. Gathering health information about patients with     acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best     treatment.   "
251094|NCT01142440|"     Our study is designed as an interventional prospective longitudinal study which examines the     Israeli defense force personnel. The population of our study is composed out of the IDF     personnel which will be randomly be subdivided into 2 different groups - one will be noted as     the intervention group and the other will function as a control group. Each participant will     be monitored for a period of 18 months.   "
251095|NCT01142453|"     This was an observational, single arm, multicentric study conducted for the adjustment of     treatment strategy and its monitoring using high-frequency and high-dosage administration of     interferon-beta (Rebif) in MS subjects. Study focussed on assessment of the effectiveness and     safety of existing immunomodulatory basis therapy in MS subjects.   "
251096|NCT01142466|"     In the course of therapy escalation, the multiple sclerosis (MS) subjects with high activity     of disease receive mainly mitoxantrone. The duration of therapy is limited because of a     cumulative dose for life (140 mg/m^2 body surface area). In practice lower doses of     mitoxantrone (60-120 mg/m^2 body surface area) are being used. The specific reason for this     limited total dose are potential cardiotoxic side effects of mitoxantrone. Once this     cumulative dose of mitoxantrone is reached and the subject becomes stable, there is the     question for subsequent therapy. A possibility at this time, is the so-called     de-escalation, therefore reducing the subject back to immunomodulating basic treatment.      The target of this open-label, randomised, multicentric, comparative, parallel-group study     was to inquire systematically into the use and course of basic therapy with Rebif 44 mcg     thrice weekly (tiw) for a larger number of subjects.   "
251097|NCT01142479|"     Many breast cancer patients will taking Chinese herbal medicine during receiving     radiotherapy. The investigators conducted the pilot study showing Compound Herbal Formula     (TPE-1) have the effect of improving the fatigue and leukopenia during radiotherapy. So the     investigators designed this double blind and controlled trial to evaluate whether TPE-1 have     the effects for leukopenia and cancer-related fatigue in breast cancer patients with     radiotherapy. From our initial observation for 2 years, TPE-1 is safety. The study is also     designed to evaluate the safety when patients taking this formula.   "
251098|NCT01142492|"     This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study on     the extent to which subject compliance is influenced by use of a variable titration regimen     at the start of treatment of relapsing MS with Rebif.   "
251099|NCT01142505|"     The clinical aim of this trial is to assess whether intermittent montelukast is an effective     treatment strategy in preschool wheeze. The mechanisms aim of the trial is to determine     whether there is a genetically highly-responsive subgroup of children. In designing this     trial the investigators have incorporated several novel aspects. First, parents will be able     to adjust the use of oral montelukast to their child's symptoms. This allows the     investigators to recruit both episodic and multi trigger patterns of preschool wheeze -     and control for any change in wheeze pattern during the trial. Second, before the     investigators issue the trial medication, the investigators will assess children's     leukotriene genes, focusing primarily on a gene called ALOX5. This ALOX5 stratification     step will ensure that an equal number of potentially treatment-responsive children receive     the active drug (montelukast) and the dummy medicine - and the equal numbers will help the     investigators to assess the role of ALOX5. For the trial, the investigators will first     recruit 1,300 children with a history of preschool wheeze, then divide them into the group     with responsive and less responsive genes by their ALOX5 status. The investigators will     then issue parents with the trial medication; 50% will be given montelukast and 50% will be     given dummy medication. Parents will start the trial medication whenever their child develops     a cold, and stop the medication when wheeze resolve. Parents will also be able to give the     trial medication for wheeze between colds. Over the 12 month trial period, the investigators     will assess the number of unscheduled attendances to a medical practitioner for wheeze for     each child. At the end of the trial, the investigators will determine whether montelukast is     effective then whether there is a difference in response to montelukast between the 2 ALOX5     gene groups.      At the same time, the investigators will measure many other genes that may influence response     to montelukast, as well as the amount of leukotrienes that are excreted in the urine before     and during attacks. Using these results, the investigators will be able to both inform     national treatment policy, and develop new concepts on the mechanism of preschool wheeze that     will inform the development of new therapies. Since children will continue to receive     normal inhaled therapy, there are no ethical issues in giving a dummy medicine to half of     the 1300 children to be recruited. The study will be the largest trial in wheezy preschool     children to date, and may open up genetic testing in preschool wheeze.   "
251100|NCT01142518|"     This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study to     investigate whether baseline treatment with high-dose interferon beta 1a (Rebif 44 μg x 3 ),     administered at a high frequency, leads to maintenance of stabilisation of the course of the     disease in MS subjects previously treated with mitoxantrone. The previous mitoxantrone     treatment of the included MS subjects was conducted in the course of a so-called escalation     according to the immunomodulatory escalation treatment plan. An additional important aspect     of the problem was the collection of safety and tolerance data during the observation phase.   "
251292|NCT01145326|"     The purpose of this study is to determine whether co-application of a functional microarray     of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is     to determine whether the depth of anesthesia is enhanced.   "
251101|NCT01142531|"     CT studies considering bronchial dimensions in chronic obstructive pulmonary disease (COPD)     were conducted without control of bronchodilation. Some data however suggest that total lung     capacity (CT scan is performed after full inspiration) is increased in individuals affected     by chronic or spontaneous bronchoconstriction and may decrease after bronchodilatation.     Furthermore, no study has assessed the effect of bronchodilation on CT scans parameters     reflecting airway remodelling and emphysema extent in COPD patients.      This is a prospective study whose purpose is to assess the effect of bronchodilation on lung     CT scan and pulmonary function testing (PFT) in COPD patients.   "
251102|NCT01142544|"     Acute lung injury in children is a syndrome of rapid onset of acute respiratory failure and     require admission into intensive care units (ICU) for advanced life support. There are almost     no information on epidemiology of acute lung injury. Published studies do not have     information for an entire year and none of them have evaluated the degree of oxygenation     failure under standard ventilator settings. The investigators will perform a 1-year     prospective audit of all patients admitted with acute lung injury in a network of pediatric     ICUs in Spain.   "
251103|NCT01142557|"     The aim of this case series was to document the effectiveness and compatibility of Rebif 44     or 22 µg in the therapy of the chronic multiple sclerosis (MS) under practical conditions on     a large collection of subjects. In addition, the side effects possibly occurring in the     initial phase of therapy and satisfaction of the subject as well as the treating doctor was     also documented.   "
251104|NCT01142570|"     This is a single-center, prospective, randomized, comparative, double-blind controlled     clinical study intended to establish 1) the optimal method of determining calorie     requirements and 2) the optimal amount of protein supply in chronically ventilated patients.   "
251105|NCT01142583|"     The Canadian Multiple Sclerosis Working Group (CMSWG) has developed practical recommendations     on how neurologists can assess the status of subjects on disease modifying drugs (DMDs) and     decide when it may be necessary to modify treatment in order to optimize outcomes. These     recommendations are based on relapses, disease progression as measured by the Expanded     Disability Status Scale (EDSS) or EDSS progression, and magnetic resonance imaging (MRI)     outcomes. The CMSWG agreed to compare post-treatment relapse rates and severity to baseline     rates and severity in each individual subject. The recommended minimum baseline reference     time frame needed to assess relapse rate was 2 years prior to treatment initiation. The     objective and prospective relapse data should be ideally collected during this reference     period. The CMSWG recommended that the following should be taken into consideration when     assessing relapse severity: the effect of the relapse on activities of daily living (ADL),     the type and number of systems involved (i.e., relapses that are polysymptomatic or that     affect the cerebellar/motor systems tend to be more severe), and whether or not a course of     corticosteroids was required. The CMSWG also recommended that, prior to considering treatment     modification on the basis of progression in disability, progression should be confirmed at 6     months.      The CMSWG's Treatment Optimization Recommendations (TORs) have been retrospectively applied     to the 4 year data set from the PRISMS study. Applying the model to subjects after their     first year on therapy allowed for accurate prediction of continued disease activity in the     form of relapses in the majority of subjects who actually experienced ongoing attacks. The     model was less effective in predicting disability progression, but this may well have been     due to the low numbers of subjects on treatment progressing over the study period. This     observational study used the TOR model to identify subjects as either candidates for therapy     optimization or as candidates to maintain current therapy. All subjects were then followed     prospectively until re- assessment will be done with this model.   "
251106|NCT01142596|"     This is a multi-site, randomized fixed-flexible dose long-term study of asenapine in     participants with schizophrenia. The first six weeks of the study will be double-blind and     the remainder of the study will be open label. Participants in this study consist of     participants who have completed the preceding short-term study (P06124 [NCT01098110]), who     meet the inclusion criteria and wish to continue receiving study drug, and whom the     investigators have deemed eligible for study participation. Participants who were on placebo     twice daily (BID) in core trial P06124 will get placebo for the first 2 weeks then 5 mg     asenapine BID for the next 4 weeks of double blind treatment, and will be re-randomized after     week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 5 mg     BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or     asenapine 10 mg BID. Participants who were on asenapine 10 mg BID in core trial P06124 will     be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. After     re-randomization, drug will be administered open-label for 46 weeks. During this period dose     is flexible can be adjusted using dose options of 5 and 10 mg BID for efficacy and     tolerability.   "
251107|NCT01142609|"     This research is being done to compare the effectiveness of standard on-site, in-person     counseling with Internet web-based videoconferencing (e-therapy) in drug-dependent patients     in opioid-agonist treatment programs. The study is looking to see if there are any     differences in satisfaction or in treatment outcome if counseling sessions are given by     e-therapy compared to standard, in-person counseling given in the clinic. The e-therapy     happens in real time- it works very much like standard therapy in the clinic except that the     patient is in his or her own home (or other convenient location outside the clinic) and talks     to and sees the therapist through an Internet connection on the computer (the therapist will     usually be at the clinic).   "
251108|NCT01142622|"     The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg     may prevent the use of morphine during the first day after laparoscopic ovarian cyst surgery.   "
251109|NCT01142635|"     Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors     to show misleadingly high values. The investigators want to investigate whether this EMG     activity can be visually seen on the anaesthesia monitor.   "
251110|NCT01142648|"     According to our experience, electroencephalogram-based indices of anaesthetic state show     elevated numbers after administration of sugammadex (new reversal of neuromuscular blockade).     This can be due to altered anaesthetic state, or some kind of artefact. In this study, the     phenomenon is evaluated in detail.   "
251111|NCT01142661|"     The purpose of this study is to provide eribulin to patients with advanced breast cancer who     have no other treatment options and therapy is requested by an Investigator.   "
251112|NCT01142674|"     The designed study follows up the retrospective previous one by the International T-cell     Non-Hodgkin's Lymphoma Study Group (International Peripheral T-Cell Lymphoma Project).      It is designed as a prospective collection of information potentially useful to predict the     prognosis of newly diagnosed patients with the more frequent subtypes of Peripheral T-cell     lymphoma (Peripheral T-cell lymphoma unspecified and Angioimmunoblastic T-cell lymphoma) and     to better define clinical characteristics and outcome of the more uncommon subtypes   "
251113|NCT01142687|"     The study is designed to determine the effects of a non-pungent supplement from sweet chilli     pepper on resting metabolic rate and diet-induced thermogenesis (DIT) after a period of very     low calorie intake over 4 weeks.   "
251114|NCT01142700|"     Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is     safe, well tolerated, and has sufficient antiviral activity to progress to late stage     clinical trials when combined with pegIFNα/RBV for treatment of chronically infected     hepatitis C virus genotype 1 treatment-naive subjects.   "
251366|NCT01146327|"     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The     primary purpose of this trial is to evaluate the safety and tolerability, and     pharmacodynamics, of multiple oral doses of PF-04620110.   "
251115|NCT01142713|"     Radiotherapy has a significant impact on local control, disease free survival and overall     survival in patients with rectal cancer T2, N1, M0 and T3-4, any N, M0. Treatment is     accompanied by side effects, mainly due to the inclusion of the small bowel and urinary     bladder in the treatment fields.      Two major modalities have been pursued to reduce the volume of small intestine and urinary     bladder in treatment volume. One is a surgical procedure, such as absorbable mesh. These     procedures have failed implementation in daily clinical practice. The second modality aims to     save the small intestine and urinary bladder from the toxicity of radiotherapy by modulating     the radiotherapy planning procedure. Using the belly board and changing the standard position     from supine to prone could achieve this aim; in part due to gravitational displacement of the     bowel. Several studies have evaluated the impact of positioning and use of belly board in     patients receiving pelvis irradiation for rectal cancer. The results are inconclusive, but     the prone position with belly board appears promising.      This study carefully evaluates the impact of patient's positioning and belly board on dose     volume histogram of small bowel and urinary bladder   "
251116|NCT01142726|"     The primary purpose of the protocol is to demonstrate the ability of abatacept plus     methotrexate to induce remission in patients with very early rheumatoid arthritis after 12     months of treatment and to maintain remission following 6 months of drug withdrawal.   "
251117|NCT01142739|"     Levodopa-induced dyskinesia severely limits the use of levodopa in Parkinson's disease and     constitutes a debilitating complication of dopaminergic treatment in late stage. Among     several neurobiological mechanisms identified so far, the investigators have established in     experimental models the key role of D1 receptor hypersensitivity and aRas-ERK signalling     pathway. As the very same dopamine receptor machinery and the Ras-ERK pathway are present in     blood lymphocytes, the investigators wish to test the hypothesis that the level of ERK     phosphorylation in lymphocytes is a biomarker of levodopa-induced dyskinesia in Parkinson's     Disease.      The study will be performed in dyskinetic levodopa-treated patients and non-Parkinson's     Disease controls. Blood sampling off and on levodopa treatment (1 hour post-dose), as     well as clinical data collection will be done during a scheduled pre-op work-up (deep brain     stimulation). Subsequently, suspended lymphocytes from blood samples will be immunolabelled     using an anti-pERK antibody and mean fluorescence intensity and percent of labelled     lymphocytes will be assessed by flow cytometry. Additionally, plasma and urine samples will     be collected on et off for dosage of dopamine. The motor effect of levodopa will be     assessed through UPRSIII rating scale and eye movement (saccades) speed by non-invasive     oculometric recordings.   "
251118|NCT01142752|"     The prevalence of preterm birth is not decreasing in the last decades despite of improving     health care. Intrauterine infections are important in the etiology of preterm birth but the     interconnection of systemic inflammation and preterm birth is not clear. Mechanisms of     preterm birth should be assessed as preterm birth is the major risk factor for morbidity and     mortality during birth, thus being important for the individual and regarding health costs.      No interventions will be carried out in this study.      Hypotheses:        1. There is a common etiology between oral and vaginal inflammation        2. Bacterial species are similar in vagina and oral cavity        3. There are similar oral and systemic immune reactions which provoke preterm birth        4. Inflammatory markers are found in pregnant women at risk and get back to normal post          partum In this matched case control study of pregnant women local, systemic and oral          inflammation markers and bacterial load are assessed to find out interconnections          between these body compartments to allow for explanation of the etiology of preterm          birth.   "
251119|NCT01142765|"     This study aims to test the safety and efficacy of six new malaria vaccines - AdCh63 AMA1,     MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP & MVA ME-TRAP. These vaccines consist of     inactivated viruses which have been modified − so they cannot reproduce (replicate) in     humans, and also to include genetic material (genes) for malaria proteins which are expressed     by the malaria parasite during both liver and blood stage infection. The vaccines are     designed to stimulate an immune response to these malaria proteins (immunogenicity describes     the nature and magnitude of this immune response) and thus provide protection against malaria     infection. The protective efficacy of vaccines will be evaluated by challenging a small     number of volunteers who have received the vaccines with malaria infection from the bites of     infected mosquitos(sporozoite challenge).   "
251120|NCT01142778|"     This randomized study will assess the effect of adding bevacizumab to trastuzumab plus     docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth     factor receptor 2 (HER2)-positive breast cancer. After 2 cycles of trastuzumab and docetaxel     once every 3 weeks, participants with a response (change in standard uptake value [SUV]) of     less than (<) 70 percent (%) on Positron Emission Tomography (PET) will be randomized in a     2:1 ratio to receive Cycles 3 to 6 of trastuzumab (6 milligrams per kilogram [mg/kg]) and     docetaxel (100 milligrams per square meter [mg/m^2]) with or without bevacizumab (15 mg/kg).     Participants with a response of greater than or equal to (>/=) 70% will receive trastuzumab     plus docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7,     and will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6     weeks after the treatment perfusion of Cycle 6. After surgery, all participants will receive     a further 11 cycles of trastuzumab plus radiotherapy (starting from 4-8 weeks after surgery     during 4-6 weeks, according to site's standard practice) with or without hormonal therapy     (mandatory if positive hormone receptors). Participants will be followed for up to 5 years     from start of neoadjuvant treatment.   "
251164|NCT01137305|"     Background and hypothesis:      Virtual reality (VR) training in minimal invasive surgery (MIS) is known to be feasible and     beneficial in surgical residency. Research on stress- coping in surgical trainees indicate an     additional impact of soft skills on VR- performance. Thus to hypothesize soft skills     predicting surgical performance in a VR- setting.      Method:      A prospective randomized controlled single center educational trial was carried out to     evaluate the impact of structured VR- training and defined soft skills such as self-     efficacy, stress- coping and motivation on VR- performance.   "
251294|NCT01145352|"     This surveillance is conducted to survey the followings under the post marketed drug     utilization on the patients who are administrated ENBREL as a treatment for active     polyarticular JIA.        1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious          adverse events        2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.   "
251121|NCT01142791|"     The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of     uterine fibroids using the enhanced sonication techniques, based on the current     commercially-approved treatment guidelines. Treatment may include up to 100% of individual     fibroid volume, within established serosal and sacral treatment margins.      The Enhanced sonication is one of the various sonication modes that may lead to increased     thermal dose volume of each sonication without additional safety risks. This is an additional     treatment tool available in the ExAblate system for the treatment of uterine fibroids.      The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE     study. FDA granted approval of Enhanced Sonication with the requirement to perform a     post-approval study to collect additional safety data when treating up to 100% of individual     fibroid volume.   "
251122|NCT01142804|"     The investigators propose a randomized controlled trial based on the Social Networks for     Activity (SNAP) Model to evaluate: (1) the effectiveness of an internet-based fitness walking     program delivered to patients with risk factors for cardiovascular disease and stroke; and     (2) the contribution of social support networks to enhancing the effectiveness of the     internet-based fitness walking program. The investigators will recruit 308 patients who are     sedentary and have risk factors for cardiovascular disease and randomly assign them to one of     the following groups: 1. Internet-based fitness walking program (WalkLink); 2. Internet-based     fitness walking program plus additional social network intervention (WalkLink+); and 3.     Minimal treatment control.      The primary specific aims of this study are to:        1. Evaluate the effects of WalkLink and WalkLink+ relative to a minimal treatment control          group on change in: physical activity, aerobic fitness, blood pressure, body          composition, and body mass index (BMI), from baseline to posttest, and at 6-month          follow-up.        2. Compare the differential effectiveness of WalkLink+ to WalkLink on change in: physical          activity, aerobic fitness, blood pressure, body composition and BMI from baseline to          posttest, and at 6-month follow-up.        3. Evaluate the mediator and moderator effects of selected individual-level self-management          skills (goal setting, planning, self-monitoring), social support variables (number of          activity partners, social cues for walking, social praise/reinforcement), and          physical-ecological variables (neighborhood walkability, physical cues for walking) on          WalkLink and WalkLink+ treatment outcomes.   "
251123|NCT01142817|"     This study will investigate the prevalence and extent of both metabolic and psychosocial     changes associated with the menopause transition over 1 year among women with HIV compared to     women without HIV of similar age, weight, menstrual status, and ethnic background. It is     hypothesized that HIV positive women will demonstrate increased abdominal fat, abnormal     cholesterol and blood sugar levels, reduced bone density, and greater psychosocial challenges     than HIV negative women during the menopause transition.   "
251124|NCT01142830|"     The primary objective is to assess the incidence and severity of pain after major craniotomy     in paediatric patients (from 1 month to 10 years of age).      The secondary objective is to determine factors associated with significant pain following     paediatric neurosurgery .   "
251125|NCT01142843|"     Mouthwash based on medicinal plants and propolis can be easily found in the Brazilian market     even if it has not been tested in reliable clinical trials on its efficacy or possible     unpleasant side effects like the ones which alter the hard and soft oral tissues. The aim of     this study was to obtain preliminary evidence of efficacy of an alcohol-free mouthwash     containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis. Were chosen     twenty-five subjects that are UFMG employees and individuals who would begin treatment on an     extension project called Supportive Periodontal Therapy at the Faculty of Dentistry of     Federal University of Minas Gerais, Belo Horizonte, from August to December 2009. The     subjects went through a dental prophylaxis before starting rinse. They were then instructed     to rinse twice a day for a minute, immediately after brushing (morning and night), using the     10 ml of the MGP 5%. After 45 and 90 days using the product the individuals returned for a     clinical evaluation which considered changes in the soft and hard oral tissues and involved     collecting plaque and gingivitis indexes. On their last appointment the subjects answered a     questionnaire about their level of appreciation and acceptability of the mouthwash.     Compliance with the treatment was also evaluated through an attendance form. For the     statistic analysis we used BioEstat 4.0 and Excel 2007.   "
251126|NCT01142856|"     The purpose of this study is to determine the safety of injecting mesenchymal stem cells     through intraspinal delivery for the treatment of ALS.   "
251127|NCT01142869|"     The aim of this prospective, observational, multicenter, post-marketing study is to evaluate     the safety and efficacy of Cetuximab (Erbitux) in combination with platinum based     chemotherapy, in the first line therapy of recurrent/ metastatic squamous cell carcinoma of     head and neck (SCCHN). A total of 100 subjects with SCCHN will be recruited in 20 centres     across India.   "
251128|NCT01142882|"     This study will evaluate the comparative effectiveness and cost-effectiveness of a     customized, interactive web-based HIV, sexually transmitted infections (STI) and hepatitis     prevention intervention as compared to a traditional, educator-delivered prevention     intervention. Both interventions will be offered to youth enrolled in outpatient,     community-based substance abuse treatment at our collaborating treatment facilities. Outcomes     to be measured include accurate HIV/disease prevention knowledge, intentions to engage in     safer sex, actual HIV risk behavior, attitudes toward safer sex and self-reported substance     use. The web-delivered intervention under evaluation has the potential to deliver     evidence-based content at low cost without increasing demands on treatment staff time or     training needs.   "
251129|NCT01142895|"     The purpose of this simulated useability study is to demonstrate the user interface and     software design mitigate potential safety concerns.   "
251192|NCT01143129|"     The DExamethasone for Cardiac Surgery - Postoperative New-onset Atrial Fibrillation     (DECS-PNAF) project described in this protocol aims to elucidate how corticosteroids protect     cardiac surgical patients from Postoperative New-onset Atrial Fibrillation (PNAF). Patients     will be randomized to receive either a single high dose of dexamethasone or a placebo.     Continuous ECG-monitoring, echocardiography and biochemical and genomic analyses will be used     to investigate the mechanisms responsible for the known protective effect of corticosteroids     in the development of PNAF.   "
251293|NCT01145339|"     The study primary objective is to compare the clinical efficacy of two formulations in the     supportive treatment of lactose intolerance.   "
251130|NCT01142908|"     Cardiovascular disease (CVD) is the leading cause of death in the United States; more than     80% of veterans have > 2 risk factors for CVD. Our study is one of the first to examine the     implementation of a tailored behavioral/educational self-management intervention in primary     care clinics designed to improve CVD risk. The proposed study could result in a leap forward     in CVD risk management among veterans for several reasons: 1) ) This is a novel extension of     our previous interventions that have demonstrated improved BP, now designed to address     multiple chronic conditions contributing to CVD risk, particularly hyperlipidemia and     diabetes. The study focuses on both multiple CVD-related risk factor management and     medication management 2) The intervention is multi-behavioral; it addresses patients' various     health behavior (e.g., smoking, diet, and medication adherence). 3) Components of the     intervention will include specific recommendations and transportability of intervention     application software and tracking packages that will allow clinic managers to implement the     intervention if it is effective.   "
251131|NCT01136863|"     FEVER is an investigator-designed, prospective, multicentre,double-bind, randomized,     placebo-controlled,parallel-group trial. The primary objective is to compare the long-term     effects on the incidence of fatal and non-fatal stroke (and secondarily of other     cardiovascular events) of administering a small dose of the calcium antagonist felodipine (5     mg once a day) or of a placebo, in hypertensive patients whose blood pressure had     preliminarily been reduced by administering a low-dose diuretic (hydrochlorothiazide,12.5 mg     once a day) to be continued in association with felodipine or placebo, throughout the trial.   "
251132|NCT01136876|"     This is a pilot study having a randomized, double-blind parallel group comparison of two     iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients     enrolled must have eGFR greater than or equal to 30 mL/min and less than or equal to 59     mL/min. Statistical summaries will be presented to analyze the various lab tests results for     the two groups.   "
251133|NCT01136889|"     1. To determine the feasibility of conducting a randomised controlled trial (RCT) of the          effectiveness of a PFMT intervention in conjunction with vaginal pessary management          versus vaginal pessary management alone for women with pelvic organ prolapse.        2. To develop and test the methods for a main trial.      The ultimate aim of a large multi-centre RCT would be to answer the question:      Is conservative management of pelvic organ prolapse with an individualised PFMT intervention     in conjunction with vaginal pessary more effective than vaginal pessary alone in reducing     prolapse-specific symptoms, prolapse severity and the need for further prolapse treatment?   "
251134|NCT01136902|"     The overall objective is to investigate, whether retinal blood vessel diameter change during     the energy consuming dark adaptation process and if responses vary between low and high blood     glucose.   "
251135|NCT01136915|"     This is a pilot study using a randomized, double blinded, comparison of two iodinated     contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled     must have and estimated glomerular filtration [eGFR] < 30 mL/min/1.73 m2. Statistical     summaries will be presented to analyse the various laboratory tests for the two groups.   "
251136|NCT01136928|"     This is a 4-week sequential drug interaction study to measure the effects of American ginseng     on efavirenz pharmacokinetics using steady-state 24-hour AUC and Cmax as the primary     comparison measures in healthy male volunteers. Efavirenz Cmin, T1/2, tmax, and clearance     will also be assessed as secondary outcome measures. This study is a phase I, prospective,     within-subject, fixed-order, two-period, multiple dose, open label, drug interaction study,     to determine the stead-state plasma pharmacokinetic profile of efavirenz before and after     concurrent treatment with American ginseng. The investigators hypothesis is that concurrent     oral administration of American ginseng for up to 14 days will not significantly alter the     steady-state plasma pharmacokinetic of efavirenz.   "
251137|NCT01136941|"     The purpose of this research study is to test the safety of Zileuton and see what effects     (good and bad) it has on you, other children and adults with Sickle Cell Disease (SCD). The     investigators also want to see how Zileuton is handled by your body at different doses.      Zileuton is a drug that is approved by the Food and Drug Administration (FDA) for the     treatment of asthma for people age 12 and older. The FDA has not approved Zileuton for the     treatment of SCD, so it is being studied as an investigational drug for SCD through an     application to the FDA. In asthma patients, Zileuton helps by reducing inflammation. This     study will see if Zileuton helps to reduce inflammation associated with SCD.   "
251138|NCT01136954|"     The purpose of this study is to assess the long-term safety and efficacy of zonisamide used     as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic     drugs (AEDs).   "
251139|NCT01136967|"     The purpose of this study is to assess the objective response rate of lenvatinib in     previously treated participants with American Joint Committee on Cancer (AJCC) unresectable     Stage III or Stage IV melanoma and disease progression.   "
251140|NCT01136980|"     The objective of the study is to evaluate the relative merits, safety and effectiveness of     the EsophyX transoral device in performing an advanced TIF procedure in patients with     troublesome symptoms as defined by the Montreal consensus definition while on PPIs compared     with sham and placebo controls.   "
251165|NCT01137318|"     The objective of this study is to evaluate a novel sequenced combination of a promising,     computerized cognitive training program targeting working memory (WM) deficits in children     with attention-deficit/hyperactivity disorder (ADHD) in combination with behavioral parent     training, a well-established, evidence-based intervention for ADHD.      The combined active intervention, compared to the combined control intervention will result     in improvement in primary psychosocial (i.e., parent/teacher reported child impairment;     parental stress; parenting behavior; and observed child academic achievement) and psychiatric     (parent/teacher rated ADHD, ODD, and CD symptoms; observed activity level and attention)     outcomes at post-treatment and follow up assessment, with the combined active intervention     resulting in greater improvements in these outcomes.   "
251193|NCT01143142|"     The goal of this study is to determine whether a two-page print brochure that delivers     individually tailored educational messages about the Human papillomavirus (HPV) vaccine     increases HPV vaccine-hesitant mothers' intentions to have their adolescent daughters     vaccinated against HPV.   "
251332|NCT01145885|"     Investigation of absorption, distribution, metabolism and excretion (ADME) and assessment of     safety, tolerability and preliminary therapeutic effects of [14C]volasertib in patients with     advanced solid tumours.   "
251141|NCT01136993|"     Objective is to describe two years experience from The Finnish Telestroke piloting between     Helsinki University Central Hospital (HUCH), Department of Neurology, The Hub, and five     hospitals, the spokes. The participating hospitals are from Rovaniemi (Lapland), Kemi     (North-West of Finland), Lappeenranta, Kuusankoski and Kotka from South-East of Finland. All     the participating hospitals have a stroke unit and the thrombolysis treatment and the follow     up of the patients are carried in the treating hospital. The aim of the pilot is to provide     these hospitals expertise in thrombolysis treatment during off-hours through     teleconsultations.      The teleconsultations were begun between the participating hospitals 05/2007 after about 1     years preparation period. During the preparation period the staff from participating     hospitals were trained with simulation training and lectures held by the local staff and the     faculty of the Helsinki University hospital.      Telestroke consultation: During two way interactive audio-visual consultation the     thrombolysis decision is based on: 1) the consultant going through a check up list of     indications and no contraindications to the treatment together with the treating physician     and 2) Clinical assessment of NIHSS by the treating physician under guidance of the     consultant through the two way video system besides 3) Evaluation of the head CT scan.      The data registered is based on documents made at HUCH and the follow up data provided by the     chief neurologist of the other hospitals. 109 teleconsultations have been documented over 2     years period. A unique feature of the Finnish pilot is the high percentage of consultations     leading to thrombolysis treatment. Another special feature is that the consultant does the     teleconsultation work besides other on call duties.   "
251142|NCT01137006|"     A dose escalation study designed to determine the safety, maximum tolerated dose,     anti-melanoma activity, antibody blood levels and progression-free survival in patients with     malignant melanoma receiving IMC-20D7S either every two weeks or every three weeks.   "
251143|NCT01137019|"     The purpose of this study is to use a high-resolution intracoronary imaging modality, called     optical coherence tomography (OCT) to examine two different types of coronary artery stents     used to treat patients with coronary artery disease.   "
251144|NCT01137032|"     The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate     cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult     subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface     area.   "
251145|NCT01137045|"     A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new     chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically     purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial     Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using     with post-exposure rabies intradermal vaccination with or without equine rabies     immunoglobulin.   "
251146|NCT01137058|"     Ubiquitous healthcare service for elderly patients with type 2 diabetes provides real-time     glycemic monitoring and glucose control implemented by clinical decision support system     (CDSS) using wire and wireless communication and information technology.      To evaluate the clinical efficacy of this system, researchers plan to compare the improvement     of glycemic control, self-management, and quality of life among three study groups: control,     self glucose monitoring, and U-healthcare group.   "
251147|NCT01137071|"     RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways.     Some block the ability of tumor cells to grow and spread. Others find tumor cells and help     kill them or carry tumor-killing substances to them.      PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy     for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube     cancer.   "
251148|NCT01137084|"     The purpose of this study was to evaluate the safety and efficacy of a steroid-free     immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.   "
251149|NCT01137097|"     Objective: To investigate the incidence of lateral neck node occult metastasis and to show     the usefulness of sentinel lymph node biopsy (SLNB) in the detection of lateral neck node     metastasis in thyroid carcinoma, the investigators used a radioisotope to detect the sentinel     lymph node.      Summary Background Data: Although occult lymph node metastasis to the lateral neck     compartment is common in papillary thyroid carcinoma, the incidence and patterns of lateral     neck node metastasis in papillary carcinoma are not known.   "
251150|NCT01137110|"     Our primary objective is to compare two treatment options for prevention of seizures     following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam     is as efficacious in the prevention of in-hospital seizures when compared to an extended     course.   "
251151|NCT01137123|"     The purpose of this study is        1. To compare the effects of the two types of thoracic esophageal cancer lymphadenectomy on          the staging and prognosis of resectable esophageal cancer, which defined by the          International Association of esophageal disease(ISDE) - standard mediastinal          lymphadenectomy,total mediastinal lymphadenectomy and three field lymphadenectomy,and to          find out reasonable range of lymphadenectomy.        2. To compare the effects of Chemotherapy Group (Docetaxel + Nedaplatin) with Control Group          on the prognosis of resectable thoracic esophageal cancer,and to explore the indications          of adjuvant chemotherapy.   "
251152|NCT01137136|"     Aromatase(CYP19)inhibitor is one of the major antihormonal drug for breast cancer in     postmenopausal women. The variation of CYP19 may affect the effect of aromatase inhibitor.     However, the incidence of variation of CYP19 in Korea has not known. Therefore, the     investigators want to know the incidence of variation of CYP19 and to assess the effect of     these variations of CYP19 to aromatase inhibitor users.   "
251166|NCT01137331|"     Seborrhoeic eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the     head and trunk where sebaceous glands are most prominent. The severity varies from mild     dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and     thick, adherent crusts. The worldwide prevalence of SE is 3-5%, although dandruff, the     mildest form of the disorder affects up to 15-20% of the population.      In this multicentre, randomised, double-blind, placebo-controlled phase III study, adult SE     patients are treated once daily for 4 weeks. The population for this study is patients with     mild to moderate SE.      The primary endpoint for this study is the efficacy of K301 compared to placebo which was     based on the sum score for erythema and desquamation after 4 weeks of daily application.     Secondary endpoints are to evaluate safety and tolerability as well as efficacy.   "
251153|NCT01137149|"     Twenty percent of adolescents will have at least one episode of clinical depression by age     18, and 65% will experience transient or less severe depressive symptoms. Depression     compromises the process of adolescent development by interfering with academic, occupational,     and social functioning, and increasing risk for substance use and suicide. Although initial     research provides some support for both pharmacological and psychosocial interventions, many     depressed teens do not respond to these interventions, and others experience a relapse of     symptoms within one year. Furthermore, concerns about antidepressant medications increasing     suicide risk have raised additional caution about use of pharmacotherapy with adolescents. As     such, the importance of developing innovative treatment options for depressed adolescents is     critical. Cognitive Behavioral Therapy (CBT) has been demonstrated to be effective in the     treatment of depressed adults, with more modest efficacy data when used with children and     adolescents. Interestingly, recent data from the adult literature suggests the positive     outcomes of CBT can be achieved and surpassed by interventions that are purely behavioral in     nature. Behavioral interventions may be easier to implement with many adolescents and may     provide a better developmental fit for depressed adolescents. The present project proposes to     develop a manualized Behavioral Activation (BA) Therapy for depressed adolescents, test its     adaptability, acceptability, and feasibility in an open clinical trial with 12 adolescents     (aged 12-17), and following further treatment refinement, test its efficacy in a randomized     controlled trial of 50 adolescents (aged 12-17), in which 25 will be randomized to BA Therapy     and 25 will receive Treatment as Usual (TAU). In this randomized controlled trial,     depressed adolescents will receive 12-weeks of BA Therapy or TAU. Psychiatric and     psychosocial functioning will be assessed at the beginning, middle, and end of treatment. A     naturalistic follow-up will be conducted 4 and 9 months post-treatment. Assuming that BA will     outperform usual approaches to therapy with depressed youth, the data will provide the     basis for the development of a larger randomized controlled trial comparing the efficacy of     BA against other widely studied approaches to the treatment of depression in youth, namely     pharmacotherapy in the form of Selective Serotonin Reuptake Inhibitors (SSRIs), and CBT.   "
251154|NCT01137162|"     Cetuximab, erlotinib, and panitumumab are all recently FDA approved epidermal growth factor     receptor (EGFR) inhibitors that treat a wide variety of tumor types, such as colon, lung, and     head and neck. Blockade of the EGFR results in inhibition of multiple downstream pathways,     leading to slowed tumor growth. In addition, these inhibitors may enhance anti-tumor immune     responses through uncharacterized mechanisms. While producing significant responses in many     settings, EGFR inhibitors also result in significant skin toxicity (rash) in a high     percentage of patients. Multiple studies have correlated the presence and severity of rash     with clinical response. Unfortunately, severe rash can often lead to dose delays, reductions,     or even discontinuation of EGFR inhibitors, thus limiting their efficacy. The mechanism of     both the rash and its correlation with tumor response is poorly understood. Skin biopsies     display a robust leukocyte infiltrate, but a systematic analysis of the type of infiltrating     leukocytes, activation state, or homing receptor expression has not been performed.     Chemokines and chemokine receptors control leukocyte trafficking to the skin and other tissue     sites, and defined receptor profiles for skin-, gut-, and lung-homing leukocytes are well     established. In this study, the investigators propose to evaluate the homing phenotype of     leukocytes from peripheral blood and skin biopsies of patients receiving EGFR inhibitors. The     investigators will use RNA microarrays to evaluate the expression of chemokines and other key     genes regulated in skin during treatment. The investigators will utilize in vitro methods to     investigate effects of EGFR inhibitors on imprinting of T cell tissue-specific homing     receptors. The investigators will examine correlations among the pathologic data, clinical     findings, and tumor response. If validated, peripheral blood evaluation could potentially be     used as a predictive indicator for patients receiving EGFR inhibitors. This study may also     identify novel targets for limiting skin toxicity while receiving EGFR inhibitors, thus     allowing maximal dosing and clinical response from these agents.   "
251155|NCT01137175|"     The low confirmed rickettsioses cases rate may indicate the presence of rickettsiosis other     than scrub typhus, murine typhus, and Q fever. The clinical presentation of rickettsiosis is     variable and atypical that laboratory confirmation is necessary. This project is aimed to set     up the laboratory to diagnose rickettsial and rickettsial like disease, which could help in     develop rapid diagnostic kits, epidemiologic surveillance and prognostic factor.   "
251156|NCT01137188|"     Controlled data show that obesity is a risk factor for psoriasis and that psoriasis severity     is correlated with the degree of overweight. No controlled interventional studies reporting     on the effect of weight loss on psoriatic skin manifestations have been published and data     from case reports are conflicting.      Patients with psoriasis demonstrate an increased susceptibility to atherosclerotic     comorbidities such as arterial hypertension, coronary vascular disease, stroke,     hyperlipidemia and type II diabetes and in severe psoriasis there is an increased risk of     early death. Lately the role of inflammation in the atherosclerotic process has been     highlighted and the link between psoriasis and atherosclerosis may be explained by the     concomitant systemic inflammation in psoriasis. Similarly a state of low level inflammation     is seen in obesity where macrophages and adipocytes begin to show overlap in function and     gene expression. This leads to an increased migration of macrophages into the adipose tissue     and an increased secretion of pro-inflammatory cytokines. In summary, these data and     theoretical considerations suggest that weight loss in obese patients with psoriasis may     improve skin manifestations and reduce the risk of atherosclerotic comorbidity.   "
251157|NCT01137201|"     To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better     than leaving them open.   "
251158|NCT01137214|"     The purpose of the project is:        1. to determine the incidence of complex sleep apnea        2. to determine what percentage of cases will resolve over time with therapy with          Continuous Positive Airway Pressure        3. Determine whether there is any difference in outcome, in those with persistent complex          sleep apnea on CPAP, between those treated with CPAP or adaptive servo-ventilation.   "
251159|NCT01137227|"     Despite the acknowledgment that physical activity is important for health, there are still     few population-based or school-based studies that uses the current physical activity     guidelines for adolescents.      Physical inactivity was defined a less than 300 min/w of moderate to vigorous-intensity     physical activity practice.      Previous research has shown very high prevalence rates of physically inactive adolescents and     a strong association with demographic, socioeconomic and biological factors.      Based on this information, the investigators are elaborating a systematic review of     literature to obtain and provide more accurate information in this context.   "
251160|NCT01137240|"     Hypothesis: Many patients with underlying mitochondrial disorders have feeding problems     because of poor gastrointestinal motility; feeding problems lead to growth impairment and     many affected children are malnourished.   "
251161|NCT01137253|"     The investigators are interested in the role of the autonomic nervous system in the     regulation of endothelial function among obese hypertensive subjects. In particular, the     investigators will study how endothelial function (response to intra-arterial acetylcholine)     changes during autonomic withdrawal.   "
251162|NCT01137266|"     The purpose of this study is to determine the effects of transcutaneous electrical nerve     stimulation (TENS) on pain and mobility by comparing different stimulation sitesP:        1. the location with the lowest resistance        2. the location that causes an irradiation sensation        3. a random stimulation site (but within a 10x10cm area of the irradiation site). The          effect is defined as the pain VAS baseline-measurement before treatment minus the pain          VAS repeat-measurement after the given treatment   "
251163|NCT01137292|"     Assessment of safety and efficacy of voriconazole in real-life setting in the treatment of     high risk patients with invasive fungal infections. The study is conducted in Slovakia only.   "
251167|NCT01137357|"     In vitro studies reveal immunomodulatory effects of probiotic bacteria that are     strain-dependent. Differential immunomodulatory in vitro capacities can not be extrapolated     directly to in vivo efficacy. Thus, in vitro screening should be followed by comparative     analysis of the selected immunomodulatory probiotic strains in an in vivo setting. Birch     pollen allergy is one of the most common forms of respiratory allergy in European countries,     and recognized by a Th2-skewed immune system. Five Lactobacillus strains will be evaluated     for their immunomodulatory properties in birch pollen sensitive subjects outside the hay     fever season. A double-blind placebo-controlled parallel study will be performed in which     subjects with a proven birch pollen allergy will consume one of 5 different probiotic     yoghurts containing 4 L. plantarum strains and 1 L. casei strain or a placebo yoghurt. Blood     samples are collected at the start and after 4 weeks. Immune parameters are determined in     serum and peripheral blood mononuclear cell cultures (hPBMC) derived from these subjects.   "
251168|NCT01137370|"     Vitamin D has been regarded to be beneficial to tuberculosis (TB) patients. The aim of this     study is to elucidate the role of vitamin D deficiency in development and treatment outcomes     among Korean TB patients. Furthermore, the impact of genotypes of vitamin D receptor gene on     TB development will also be evaluated.   "
251169|NCT01137383|"     The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD     pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be     treated using standard guidelines for hepatitis C. Response to treatment and side effects     will be recorded.   "
251170|NCT01137396|"     The medication modafinil has been shown to reduce cocaine use in some cocaine users. The     investigators have shown that modafinil taken in the morning improves sleep in chronic     cocaine users. The investigators hypothesize that the beneficial effects of modafinil in     reducing cocaine use may be related to specific effects modafinil has on sleep. This study     will measure sleep and cocaine use in cocaine dependent persons who are trying to stop using     cocaine, and will test the connection between modafinil's effects on sleep and cocaine use.   "
251171|NCT01137409|"     The aim of this study is to determine if stress first pass imaging in conjunction with a     nuclear scan will improve the sensitivity for detecting heart disease. This study will also     test the usefulness of a nuclear medicine camera, CDLCAM One Pass Angiography system.   "
251172|NCT01137435|"     This safety surveillance study is being conducted in accordance with Korea Food and Drug     Administration (KFDA) Notification No. 2009-46 Basic standard for reexamination of new     drug.      The study objective is to assess within 30 days post-administration, the safety of ADACEL™     administered under the real clinical practice.   "
251173|NCT01137448|"     The purpose of this study is to evaluate the effect that weight loss has on the severity of     psoriasis in obese subjects. Fifty obese (BMI equal to or greater than 30) patients with     moderate to severe plaque psoriasis will be enrolled in a weight loss intervention program.     The severity of their psoriasis will be reevaluated at month 3 and month 6 of the program to     determine what effect weight loss has had on their psoriasis. Serum TNF-alpha will be     measured at month 0 and month 6. The hypothesis that will be tested is that weight loss will     lead to a significant improvement in the severity of psoriasis and a reduction in TNF-alpha     levels.   "
251174|NCT01137461|"     The objective of this study is to evaluate the efficacy of embryo transfer procedure guided     by transvaginal ultrasound versus abdominal ultrasound in recipients of oocytes as well as     the advantages and disadvantages of the new technique.   "
251175|NCT01137474|"     The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve     (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who     are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The     safety of this treatment will also be studied.   "
251176|NCT01137487|"     Early enteral feeding is a key component of the management of critically ill patients     receiving mechanical ventilation. However, enteral feeding has been associated with serious     complications such as aspiration followed by ventilator-associated pneumonia (VAP). Many     critically ill patients experience poor tolerance of early enteral nutrition because of     impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased     gastric volume, gastroesophageal reflux, vomiting, aspiration, and VAP. Routine monitoring of     residual gastric volume (RGV) to minimize the risk of aspiration is standard practice. RGV is     assumed to reflect gastric content, with high RGVs indicating impaired gastric emptying that     requires discontinuation of enteral feeding in order to prevent aspiration.However, RGV     measurement is neither standardized nor validated. The cut-off value that may indicate an     increased risk of aspiration and therefore a need for discontinuing enteral feeding has not     been determined, and cut-offs used in studies have ranged from 150 to 500 ml. No data are     available to support a correlation between RGV and the rates of adverse events. In     experimental studies, RGV failed to correlate with vomiting, aspiration, or VAP. The     investigators hypothesize that RGV monitoring fails to decrease the risk of VAP and leed to     inappropriate interruptions in enteral feeding with a risk of underfeeding. To assess the     effects of not measuring RGV on VAP and enteral feeding delivery, the investigators designed     a prospective randomized controlled study.   "
251177|NCT01142921|"     The aim of this study is to determine the average patency period of the new anti-reflux     biliary stent on patients with malignant bile duct strictures and to determine if this stent     remains patent for a longer period of time comparing with the ordinary plastic Tannenbaum     biliary stent.   "
251190|NCT01143090|"     Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a     potential new antipsychotic treatment for patients with schizophrenia. Switching between     antipsychotic medications is common in the treatment of schizophrenia. The purpose of this     study is to characterize the long-term safety and tolerability of lurasidone in subjects with     schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects     completing the core study (D1050289-NCT01143077).   "
251191|NCT01143103|"     The present study aims to compare the efficiency of respiratory therapy with cough assist and     the efficiency of usual respiratory therapy in intensive care patients suffering of     neurologic disorder and cough ineffectiveness. The investigators hypothesis is that cough     assist is more efficient than usual respiratory care in this group of patients.   "
251178|NCT01142934|"     TegaCHG is a multicentric randomized study aimed at evaluating the possibility that the use     of TegaDerm CHG dressing may reduce the incidence of catheter related blood stream infections     (CRBSI). It implies the comparison between the incidence of CRBSI in patients with central     venous catheter dressed with TegaDerm without chlorhexidine gluconate (CHG) and with CHG. The     primary endpoint is the occurrence of CRBSI and the secondary endpoints are:      catheter colonization (growth of microbes from the culture of catheter tip, > 15 CFU     according to semi-quantitative method or > 1000 CFU according to quantitative method);     incidence of catheter exit site infection; occurrence of catheter related infections/sepsis     or other severe infection-related complications; safety profile evaluation: occurrence of     hypersensitivity to the dressing on the basis of local objectivity (erythema, edema, other)     or on that of patient symptoms (itch, burning sensation); relating to the device performance:     incidence of high/medium/low dressing edge lift, ability to visualize the catheter insertion     site, easiness of removal, easiness of dressing application; incidence of unscheduled     dressing change. The study hypothesis implies that the use of slow release device containing     chlorhexidine may decrease the incidence of CRBSI. This has already been showed for     chlorhexidine impregnated sponges. Scope of the study is to verify if this property is also     true for TegaDerm CHG,which is a new chlorhexidine-releasing dressing in which the medication     is directly released by an integrated transparent gel pad, so that the catheter exit site     remains visible and easy to inspect without removing the dressing.   "
251179|NCT01142947|"     Inhaled corticosteroids (ICS) are considered first-line treatment for persistent asthma, yet     little is known about the genetic factors that influence response to this therapy. This study     seeks to quantify response to ICS therapy in African American and white patients, as well as     look for genetic markers that predict treatment response.   "
251180|NCT01142960|"     With the rapid growing aging population, age-related eye diseases including cataract are     becoming more prevalent. The demand for cataract surgery and post-surgical care posed     enormous financial burdens to the government.      Lycium barbarum contains lutein and zeaxanthin which can filter the phototoxic blue light and     neutralize the reactive oxygen species, thus provide a protective effect against cataract     formation.      This study aims to determine the effects of Lycium barbarum Supplements on the progression of     senile cataract in Hong Kong Chinese elderly.   "
251181|NCT01142973|"     Study Type: Observational Study Design: Observational Model: Defined Population Observational     Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective   "
251182|NCT01142986|"     This research is being done to evaluate the effectiveness of three different treatment     strategies for helping subjects begin and adjust to methadone maintenance treatment at     Addiction Treatment Services (ATS). Subjects will be randomly assigned to one of three     treatment conditions: 1) Voucher-Based Stepped Care (VBSC) induction, 2) Low-threshold     Stepped Care (LTSC) induction, or 3) Routine Stepped Care (RSC) induction. It is hypothesized     that subjects in both the VBSC and LTSC condition will remain in treatment longer than     subjects in the RSC condition. In addition, it is hypothesized that VBSC and LTSC subjects     will have less drug-positive urine samples and will report less infectious disease risk     behaviors than RSC subjects.   "
251183|NCT01142999|"     The purpose of this protocol is to determine the feasibility of doing larger follow-up     studies examining whether emollients used from birth can prevent eczema in high-risk babies     and to help investigators find out if emollients (moisturizing skin creams) used from birth     can prevent eczema in high-risk babies. Hypothesis: Enhancing the skin barrier from birth     using emollients will prevent or delay the onset of eczema, especially in predisposed     infants.   "
251184|NCT01143012|"     The objective of this study is to determine whether group educational visits improve the     quality of life of patients referred to the Dermatology Clinic. Secondary outcomes will be to     determine whether group educational visits influences other key elements of patient care such     as topical steroid usage, disease exacerbations, emergency visits, and phone calls to the     office. Lastly, the investigators hope to evaluate which aspects of the educational visit     were found to be the most helpful to families caring for children with atopic dermatitis     (AD). Patients will be new atopic dermatitis referrals to OHSU dermatology and pediatric     dermatology clinics. All consecutive patients with such appointments during a three month     time period will be screened for participation in the study. Parents will be recruited via     telephone. In the intervention group, parents will be invited to participate in a group     education visit prior to their first appointment with a dermatologist. All parents in the     study will fill out questionnaires. The children involved in the study will be assigned an     eczema severity score during their routine visits, but this will be incorporated into the     regular clinic assessment. The Childhood Atopic Dermatitis Impact Scale (CADIS) assesses the     quality of life in households with children who have atopic dermatitis. The Eczema Area and     Severity Index (EASI) measures the extent and severity of the patient's atopic dermatitis.     The change in CADIS scores will be analyzed to determine if there is a more significant     improvement in quality of life for the group in which parents receive the group eczema     education visit.   "
251185|NCT01143025|"     The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 50 mg,     100 mg or 150 mg may prevent the use of morphine during the first day after laparoscopic     cholecystectomy.   "
251186|NCT01143038|"     The purpose of this study is to describe the number of months with a platelet response over a     12 month treatment period and to describe ITP remission rates in adults with ITP receiving     romiplostim.   "
251187|NCT01143051|"     This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine     Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers.     Safety of E004 will also be evaluated, under augmented dose conditions.   "
251188|NCT01143064|"     The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the     injury for a total of 120 hours to severe traumatic brain injury patients improves their     recovery.   "
251189|NCT01143077|"     Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a     potential new antipsychotic treatment for patients with schizophrenia. Switching between     antipsychotic medications is common in the treatment of schizophrenia. The current study is     designed to evaluate the effectiveness, safety, and tolerability of switching clinically     stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their     preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.   "
251194|NCT01143155|"     Although failure and mortality are the most relevant outcomes in patients with     Community-acquired Pneumonia (CAP), there is little discussion in the literature on their     incidence and etiology. A pathophysiological approach has been recently developed and used to     evaluate clinical failure in CAP patients. Clinical failure has been analyzed as related     versus unrelated to CAP, considering the role that the pulmonary infection and the     inflammatory response played in the development of this outcome. Cardiac events were     identified as triggers of clinical failures in a significant percentage of CAP patients. The     development of cardiovascular events have been also identified in CAP patients both on     admission to the hospital and during hospitalization. However, data on this topic belong to     studies evaluating only selected populations of veteran patients with CAP. Understanding     clinical failure, as well as cardiovascular events in hospitalized patients with CAP would be     useful in order to prevent complications during the hospitalization, to develop new treatment     modalities and, thus, to improve outcomes.      The objectives of this international, multicenter, observational, prospective cohort study     will be: 1) To define incidence, timing, etiology and risk factors of clinical failure,     related vs. unrelated to CAP, in hospitalized patients with CAP; 2) To define incidence,     timing, and risk factors for cardiovascular events either on hospital admission or during     hospitalization in hospitalized patients with CAP.Consecutive adult patients hospitalized for     CAP in acute care hospitals in Europe and US will be enrolled. Daily clinical evaluations.     Demographics, history, clinical, radiological, and antibiotic therapy data will be recorded,     as well as serum, urinary and respiratory samples will be collected both on admission and     during hospitalization from consenting individuals. Patients will be classified as having a     CAP-related versus CAP-unrelated failure, according to a pathophysiological classification.     Patients will be also classified as having or not a cardiovascular event either on admission     or during hospitalization.The following outcomes will be measured:      1) Incidence, timing, etiology and risk factors of clinical failure related vs. unrelated to     CAP; 2) Incidence, timing and risk factors of cardiovascular events; 3)time to clinical     stability, length of hospital stay, mortality at hospital discharge, and mortality at 30 and     180 days.   "
251195|NCT01143168|"     The purpose of this study is to evaluate the feasibility, efficacy and safety of     transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal     stem cells for patients with type 1 diabetes mellitus   "
251196|NCT01143181|"     CMX001 is an orally administered lipid conjugate of the synthetic nucleotide analog cidofovir     (CDV). The conjugate is believed to be absorbed in the small intestine then delivered to     target organs throughout the body where it crosses cell membranes by facilitated and passive     diffusion. Inside the cell, CMX001 is cleaved by intracellular phospholipases to release CDV     which is converted to the active antiviral agent, CDV-diphosphate (CDV-PP), by intracellular     anabolic kinases. Adults and adolescents, regardless of viral infection/disease, will have a     maximum weekly dose of 200 mg i.e., 200 mg once weekly OR 100 mg twice weekly; not to exceed     4mg/kg total weekly dose. Pediatric subjects (< 12 years), regardless of viral     infection/disease, will have a maximum weekly dose of 4 mg/kg i.e., 4 mg/kg once weekly OR 2     mg/kg twice weekly.   "
251197|NCT01143194|"     The purpose of this study is to investigate the effects of the dietary supplement oréVida™     (active ingredient on the basis of a culinary herb)administered twice daily in an acute study     on an improvement in vigilance, attention, concentration, memory and mood in 45 healthy men     and pre-menopausal women, aged 35-50 years, inclusive.      oréVida™ is considered a dietary supplement, and therefore it is not an approved drug by the     Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug     Administration does not strictly regulate herbs and dietary supplements. We do not claim that     this supplement is meant to treat any ailment.   "
251198|NCT01143207|"     A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is     adequate for effective contraception   "
251199|NCT01143220|"     The purpose of this clinical investigation is to assess the programming behavior of the     physicians in the patient cohort. Furthermore, the acceptance level of specific programming     recommendations based on the patient's clinical needs and primary indications will be     evaluated by comparing parameters determined by the feature IBP to daily life programming     chosen by physicians.   "
251200|NCT01143233|"     The study is conducted to examine the suitability of partially respectively extensively     hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term     infants.      Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with     modified protein content is non inferior compared to a standard infant formula based on a     Protein hyrolysate in respect to proper growth of healthy, term infants within the first four     month of life.      4-year follow-up (without further Intervention) will focus on body composition and allergic     predisposition.   "
251201|NCT01143246|"     This study is designed to evaluate the efficacy and safety of intravenous Lucassin®     (terlipressin) versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in     subjects receiving standard of care albumin therapy.   "
251202|NCT01144156|"     The study hypothesis is that adalimumab induces mucosal healing in the small bowel and that     mucosal healing correlates with disease activity. 30 Patients with isolated active small     bowel Crohn's disease which are candidates to receive anti-TNF treatment will be included in     the study. All patients will undergo patency capsule examination and capsule endoscopy     afterwards. Small bowel endoscopic disease severity will be assessed by the capsule endoscopy     Crohn's disease activity index (CECDAI). The patients will receive Adalimumab     (Humira)injections (160mg,80mg and 40mg every 2 weeks ) for 12 weeks. on week 14 a second     capsule endoscopy will be performed and CECDAI calculated again. The patients clinical     condition, CDAI,IBDQ and laboratory results including CRP, CBC and fecal calprotectin will be     assessed on weeks o, 7 and 14 and results will be compared with the endoscopic score.   "
251203|NCT01144169|"     The main goal of this research study is to determine whether treating patients with renal     cell cancer with hydroxychloroquine before surgery can make the cancer easier to kill.     Another goal is to see how the study drug affects the body's immune cells which fight cancer     cells.   "
251204|NCT01144182|"     Heart failure (HF) greatly increases mortality and lowers quality of life (QOL). HF is the     most common indication for readmission in older adults and the most frequent reason for     30-day readmission. Medications and restriction of dietary sodium constitute crucial therapy     to lower HF recurrence. However, adherence to medications and dietary recommendations is low     in HF patients. Nonadherence is often due to an interaction among the environment, the     patient and providers. In the VALOR in Heart Failure Study, we will assess a novel quality     improvement program (QIP) to improve HF care using a pretest-posttest design. This     interdisciplinary theory-based prospective experimental study will target improving HF     treatment using patient-based behavioral and checklist intervention, as well as provider and     system-targeted checklists and treatment defaults (posttest or intervention phase); this will     be compared to current best practice (CBP) evaluated in the pretest (pretest or     pre-intervention) phase. It is hypothesized that the QIP, which intervenes on patient,     provider and system levels, will improve QOL and lower HF recurrence compared to CBP.   "
251333|NCT01145898|"     To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive     ocular blood flow and in relation to visual field progression and optic nerve structural     changes in an ongoing 3 year prospective study involving 120 patients with open angle     glaucoma.   "
251205|NCT01144195|"     First line chemotherapy treatment regimens for metastatic colorectal cancer (mCRC) present     disease-free survival of more than 10 months, and as much as 12 and 15 months for many     patients.      It is evident that there are 2 groups of patients with metastatic colorectal cancer(mCRC):     those who progress during first line treatment or in the 6 months following the last     chemotherapy infusion and those who progress after this first 6-month period.      There are currently no studies evaluating the efficacy of second line chemotherapy regimens     according to the duration of response to first line treatment. It seems logical that patients     with less aggressive tumours will benefit more from treatments targeting specific proteins,     such as panitumumab, due to the shorter duration of these tumours cell cycle, which makes     them less sensitive to chemotherapy.      This study is therefore justified to determine an increase in activity and control of the     disease in patients who progressed after 6 months of the last first line chemotherapy     infusion for metastatic colorectal cancer(mCRC) in subjects expressing wild-type KRAS.   "
251206|NCT01144208|"     The purpose of this study is to evaluate if poor bone quality increases the risk of specific     types of treatment complications in patients with distal radius fractures treated with open     reduction and Locking Compression Plates(LCP).   "
251207|NCT01144221|"     This is an evaluative, monocentric study in patients with chronic ischemic heart disease and     left bundle branch block who received an ICD-CRT. It is an early investigation on the safety     and effects of a single administration of bone marrow derived mononuclear cells after     implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.   "
251208|NCT01144234|"     HIV /AIDS is a major public health problem in Uganda. The prevention of mother to child     transmission of HIV/ AIDS (PMTCT) was launched in Uganda in November 2001 and in Mbale     Hospital in May 2002. Currently, PMTCT services have been integrated into mainstream     antenatal care services throughout the country.      Though engaging men as partners is a critical component in the PMTCT programme, their     involvement has been low. Measures to increase male partner involvement in the PMTCT     programmes have not been explored in Uganda.      Objectives: To determine the effect of a written invitation letter to the spouses of women,     attending their first antenatal visit on: (a) couple attendance at subsequent antenatal     clinic visits; and (b) couple acceptance of HIV testing.      Study site: The study will be carried out at Mbale Regional Referral Hospital in eastern     Uganda      Study design: A randomised clinical trial among 1060 (530 intervention and 530 control) new     antenatal attendees. The intervention will be a written invitation letter to their spouses.      Outcome measures: The main outcome measure is the proportion of pregnant women who come with     their partners for ANC at the subsequent antenatal visit.      Utility: The results of this study will be utilised in re-orienting the ANC services to     encourage male participation and hopefully improve the uptake of the PMTCT services at Mbale     Regional Referral Hospital.   "
251209|NCT01144247|"     The purpose of this research study to determine if treating recurrent malignant gliomas with     another person's (donor) immune system cells known as aCTL cells, will be safe. This study     will also try to determine if persons who receive aCTL's are more or less likely to survive     their brain tumor than persons who had similar tumors in the past. Approximately 15 patients     will be enrolled at UCLA.   "
251210|NCT01144260|"     A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic     Lymphocytic Leukemia (B-CLL).   "
251211|NCT01144273|"     Randomized double blind placebo controlled trial on transversus abdominus plane block     approached from abdominal cavity, in patients undergoing total abdominal hysterectomy.   "
251212|NCT01144286|"     In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal     candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will     be conducted to compare the therapeutic efficacy, safety and tolerability of three different     doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).   "
251213|NCT01144299|"     This study is designed to test the immunogenicity and reactogenicity of the     Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for     the 2010-2011 season.   "
251214|NCT01144312|"     The aim of this study was to characterize pharmacokinetics of fentanyl during and after     Living Donor Liver Transplantation (LDLT), using population pharmacokinetic analysis with non     linear mixed effects modeling.   "
251215|NCT01144325|"     The purpose of this prospective randomized study is to compare clinical outcomes from two     different patient position(prone vs left decubitus)with thoracoscopic esophageal mobilization     in the procedure of Minimally Invasive Esophagectomy (MIE).        -  Comparing morbidities from the two groups        -  Comparing short-term quality of life from the two groups        -  Comparing oncological results (3,5 year survival) from the two groups   "
251217|NCT01144351|"     The purpose of this study is to determine the safety and tolerability of ELND002 in patients     with relapsing forms of secondary progressive multiple sclerosis (SPMS) or     relapsing-remitting multiple sclerosis (RRMS).   "
251218|NCT01144364|"     This study will evaluate the efficacy and safety of brief induction therapy with a     chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with     MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the     target sample size is 100-500 individuals.   "
251219|NCT01144377|"     The primary objectives of this study include evaluating the dose response of LY2541546 using     bone mineral density (BMD) change from baseline as compared to placebo, and evaluating the     overall safety and tolerability of LY2541546 following multiple subcutaneous administrations     in postmenopausal (PMP) women with low BMD. Following the last dose of study drug,     participant's will be able to participate in a 12 month extension to collect additional     safety and efficacy data (no further treatment will be administered during this extension).   "
251220|NCT01144390|"     The purpose of this study is to explore barriers and determine whether optimizing protocol is     effective in the treatment of heroin dependence in community-based MMT clinics.   "
251334|NCT01145911|"     To determine the relationships between ocular hemodynamics and glaucomatous optic neuropathy     progression.   "
251295|NCT01145365|"     This study is looking at the advantage of establishing surgical drainage for Crohn's fistulas     and abscesses prior to starting medical therapy.   "
251221|NCT01144403|"     This multicenter, open-label study will assess the efficacy and safety of MabThera     (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell     Lymphoma not eligible for autologous stem cell transplantation. Participants will receive     MabThera (372 mg/m^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to     standard chemotherapy for 6 cycles. In participants experiencing complete or partial     response, MabThera will be continued as consolidation therapy for 2 more cycles.   "
251222|NCT01144416|"     The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is     non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during     the first week of ovarian stimulation in terms of the number of vital pregnancies (ie,     presence of at least one fetus with heart activity as assessed by ultrasound at least 35 days     after embryo transfer) in women aged 35 to 42 years undergoing controlled ovarian stimulation     (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).   "
251223|NCT01144429|"     Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the     correct dose.      4 concentrations of a birch pollen allergen extract are applied in this study. Duration of     therapy 20 weeks. Primary criterion is the Conjunctival Provocation Test (CPT), i.e.     comparison between treatment arms of increased amount of quantities of allergen to provoke a     positive CPT at the end of treatment.   "
251224|NCT01144442|"     This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian,     fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive     surgery following by adjuvant chemotherapy. It is expected that this first surgery was     optimal - as defined as no residual tumor > or = 1 centimeter. Patient has clinical evidence     of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate)     heated and administered into the abdomen, followed by hyperthermic intraperitoneal     chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after     surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for 6     cycles.   "
251225|NCT01144455|"     The purpose of this study is to determine whether Gemcitabine versus Gemcitabine and TH-302     are effective in the treatment of subjects with first-line metastatic pancreatic     adenocarcinoma.   "
251226|NCT01144468|"     The NCIC CTG was conducting an international breast cancer prevention trial (MAP.3) examining     the effects of a new therapy (exemestane) for breast cancer prevention in postmenopausal     women at increased risk of developing this disease. Results showed that after a median follow     up of 35 months, exemestane was superior to placebo in breast cancer prevention. Exemestane     blocks estrogen production, which may be beneficial for preventing breast cancer, but may     have negative effects on bone. As postmenopausal women are at risk for developing     osteoporosis, determining whether exemestane causes bones to weaken is crucial for women     considering it for long-term use. Dr. Cheung's team followed the bone health of 354 women in     MAP.3 in detail over 2 years and found that volumetric bone mineral density (by high     resolution peripheral quantitative computer tomography (HR-pQCT) at the radius and tibia as     well as areal bone mineral density by dual energy x-ray absorptiometry (DXA) at the hip and     spine decreased significantly with the use of exemestane. The long term effects of exemestane     on bone will be examined up to 5 years of therapy and then 2 years post therapy to delineate     the effects of exemestane on bone strength. This research will inform us on the safety of     exemestane for breast cancer prevention.   "
251227|NCT01144481|"     Bone is the most common site of distant breast cancer recurrence, and 65-75% of women with     advanced breast cancer will develop bone metastases during the course of their disease. The     most pressing problem in management of bony metastases today, is the inability to reliably     identify patients at high risk for skeletal related events (SREs) (such as bone fractures,     surgery/radiotherapy for pain or prevention of fractures, high calcium levels, and spinal     cord compression) despite the standard use of bone medication (bisphosphonates). Using the     latest innovations both in imaging and blood tests, this novel pilot project will develop a     risk model for predicting bone metastases, which will be able to identify patients who would     most benefit from novel treatments, such as the multikinase inhibitor Zactima and the Src     inhibitor, AZD0530. Given that approximately 1/3 of patients with metastatic breast cancer     and bony disease will sustain an SRE despite use of a bisphosphonate, there is an urgent     unmet need in this large population to introduce effective bone protective agents.   "
251228|NCT01144494|"     Investigate nocturnal effects on aqueous humor dynamics of a clinically used eye pressure     -lowering drug, brimonidine, when given for six weeks.   "
251229|NCT01144507|"     The specific aims for this study are:        1. To determine if sonographic findings predict the risk of progression of liver disease to          cirrhosis by comparing cystic fibrosis subjects with heterogeneous echogenicity pattern          on ultrasound to those with normal echogenicity pattern on ultrasound        2. To develop a database and biorepository of serum, plasma, urine and DNA to aid the          investigations in ascertaining the mechanisms, consequences, genetic risk factors and          biomarkers for the development of cirrhosis        3. To determine if there are differences in health related quality of life, pulmonary or          nutritional status in children with cystic fibrosis who have a heterogeneous echo          pattern on ultrasound compared to those who have a normal echo pattern on ultrasound        4. To determine if Doppler velocity measurements of hepatic and splenic vessels predict an          increased risk for the development of cirrhosis.        5. To determine if cirrhosis on ultrasound progresses to portal hypertension during the          study period        6. To determine if homogeneous liver progresses to either cirrhosis or heterogeneous liver.   "
251230|NCT01144520|"     The purpose of this study is to study impairment of white blood cell function in patients     with type II diabetes.   "
251231|NCT01144533|"     The purpose of this study is to compare the efficacy of intra-articular steroid injection,     sodium hyaluronate injection, a combination of the two, and placebo in the treatment of     adhesive capsulitis of the shoulder.   "
251279|NCT01145157|"     This is a prospective, randomised clinical outcomes study comparing the Signature     Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted     Navigation, using Vanguard Knee System. The aim of the study is to evaluate the safety and     efficacy of TKA using Signature Personalised Patient Care compared to Conventional TKA and     Computer Assisted Navigation.   "
251335|NCT01145924|"     Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes   "
251232|NCT01144546|"     Hypotension frequently occurs during anesthesia induction. Preload decrease by anesthetics     was often considered as one of main causes for this hypotension. However, the studies on this     topic have been lacking. Dynamic preload indices are more suitable than static preload     indices to predict the effect of preload changes. And, recently, passive leg raising test     showed successful results to predict fluid responsiveness in patient with spontaneous     ventilation.      The investigators hypothesized that hypotension after induction of anesthesia is caused by     decrease of preload by anesthetics and passive leg raising test could predict this     hypotension. In this study, the investigators will try to evaluate whether passive leg     raising induced hemodynamic changes could predict hypotension during anesthesia induction.   "
251233|NCT01144559|"     This is a research study to determine if the way local anesthetic- or numbing medication- is     delivered through a tiny tube next to the nerves that go to the thigh affects the strength     and sensation in the thigh.   "
251234|NCT01144572|"     The purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC     patients during adjuvant AIs treatment in terms of: the change of the trial outcome index     (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit     approximately 500 patients from 21 sites in China. The patients should be postmenopausal HR     (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.   "
251235|NCT01144585|"     Remote Ischemic Preconditioning(RIPC) and remote ischemic postconditioning(RIPoC) seems to     have a protective effect during ischemic period. Using cardiopulmonary bypass(CPB) during     open heart surgery reduces pulmonary blood flow and may cause ischemic damage to lung tissue.     The investigators anticipate that RIPC and RIPoC may reduce lung injury after CPB.   "
251236|NCT01144598|"     The objective is to measure time delay from onset of symptoms to diagnosis and time to     disease-modifying anti-rheumatic drug treatments in Turkish patients with rheumatoid     arthritis. The investigators will also evaluate actual work limitation status of patients and     impact of demographic and clinical factors on work limitations in rheumatoid arthritis     patients.   "
251237|NCT01144611|"     This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed     to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in     reducing the pro-inflammatory post-surgical responses and thereby preserving organ functions     in patients undergoing invasive cardiac surgery: combined aortic valve replacement and     coronary artery bypass grafting.   "
251238|NCT01144624|"     The two co-primary objectives of this study are to assess in Japanese patients with severe     sepsis and/or septic shock: 1) the safety and tolerability of two different doses of     intravenous AZD9773 and 2) the PK of AZD9773.      The secondary objective is to make a preliminary assessment of the pharmacodynamics of two     different doses of intravenous AZD9773 in Japanese patients with severe sepsis and/or septic     shock.   "
251239|NCT01144637|"     A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and     safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in     healthy, vaccinia-naïve subjects.   "
251240|NCT01144650|"     The main purpose of the study is to get information about the safety and efficacy of     treatment with Dapsone to prevent the disability after ischemic Stroke, in patients diagnosed     with anterior territory brain infarct.   "
251241|NCT01144663|"     The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate     vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2     months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be     co-administered.   "
251242|NCT01144676|"     The proposed study is a single-center, double-blind, randomised, placebo-controlled trial to     evaluate the delivery of dapivirine from matrix vaginal rings over a 56 and 57 day period and     to assess the safety as compared to placebo vaginal rings in 48 healthy, HIV-negative,     sexually active women.   "
251243|NCT01144689|"     The purpose of this study is to assess the effects of mindfulness training (MT) compared to     standard Smoking Cessation Therapy (SCT) on smoking cessation and stress provocation in     individuals trying to quit smoking.   "
251244|NCT01144702|"     The purpose of this study was to evaluate the effectiveness of the fixed combination of     artesunate+mefloquine in the treatment of uncomplicated malaria caused by Plasmodium     falciparum in the municipality of Cruzeiro do Sul, Juruá Valley, Brazil, where it was being     used as specific first-line drug.   "
251245|NCT01144715|"     The purpose of this research is to evaluate a therapy delivery system for stroke patients     that provide accessible, affordable stroke care. User-friendly home therapy robots and a     telerehabilitation system are combined to monitor and provide therapy that is accessible for     patients in rural and underserved locations. The robotic-based home therapy intervention will     produce significantly greater improvement in upper extremity motor function than Usual and     Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation     program at the end of 8 weeks of home therapy.   "
251246|NCT01144728|"     Primary Objective:        -  To describe the conditions of initiation and titration of Amaryl M, according to          previous treatment:        -  initial dose        -  titration scheme        -  efficacy after 4 months assessed by HbA1C        -  tolerability (number and severity of hypoglycaemia)      Secondary Objective:        -  Fasting Plasma Glucose        -  Weight evolution   "
251257|NCT01144871|"     This study will provide new and important information regarding parental knowledge and     attitudes of confidential STI and related health care services (prevention, diagnosis and     treatment) for teens that may be needed to address the STI epidemic. Using both qualitative     and quantitative methods, this study will gather information necessary to develop effective     interventions aimed at the often neglected parent component of the teen-parent-health care     provider partnership by giving parents knowledge and skills to help them facilitate their     adolescent's access to confidential STI services as needed.   "
251280|NCT01145170|"     The study consists in only one treatment group, which will receive the first-line therapy for     the disease - standard radiotherapy and a 150 mg/m2 dose of the investigational product     (nimotuzumab)   "
251349|NCT01146106|"     This is a single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg     Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in     Healthy Volunteers.   "
251247|NCT01144741|"     Freeman-Sheldon syndrome (FSS) is a rare muscle disorder present before birth, involving     primarily problems of the face and skull and the hands and feet.      This is a study of problems, experiences, helpful treatments, and quality of life focusing on     patients with FSS but including patients with Sheldon-Hall syndrome (SHS), distal     arthrogryposis type 1 (DA1), and distal arthrogryposis type 3 (DA3), also called Gorden     syndrome. These and related disorders are very challenging to treat, partly because the big     differences in individual patients and lack of information on previous clinical experience     with treatment options. It is hoped the study will identify areas for further research in     physiology and therapy.      This study will cover all types of treatment [medical (non-surgical), including psychiatric,     and surgical treatments], even unconventional. It also includes questions about effects on     the patient's thoughts, feelings, quality of life, and relationship with siblings, family,     and parents' and if any intervention was required or advised. This study will also look for     similarities and differences in patients who meet the head and face part of the diagnostic     criteria but do not meet all other parts and patients who met the full diagnostic criteria.     There will be questions about problems or experiences to investigate if both groups of     patients may have the same syndrome. Treatment success depends on getting a correct     diagnosis.   "
251248|NCT01144754|"     This is a multi-center observational study to assess addition of Rituximab in the treatment     of previously untreated patients with Diffuse Large B-Cell Lymphomas(DLBCL) over an     enrollment period of 60 months. Patients in this study are enrolling for the collection of     their data on observations made during normal clinical practice.   "
251249|NCT01144767|"     Despite the recognized health benefits of a physically active lifestyle, mid-life and older     low-income and ethnic minority adults, including Hispanic Americans, are among the least     active and understudied groups in the U.S. This research aims to develop and evaluate a     bi-lingual physical activity promotion program, applying easy to use state-of-the-art     computer technology, which is tailored to the preferences and needs of mid-life and older     Latino adults. Such computer-based programs represent a potentially low-cost means for     reaching the large proportion of low-income and ethnic minority Americans who are     under-active.   "
251250|NCT01144780|"     The objective of this study is to better understand the underlying pathogenetic mechanisms of     MPDs. We will collect peripheral blood samples from MPD patients and utilize multiparameter     phospho-specific flow cytometry to investigate dysregulated signaling in blood cells from     these patients. This will provide deeper insights into the pathogenesis of MPDs and may lead     to the identification of novel targets for therapeutic intervention.   "
251251|NCT01144793|"     The purpose of this study is to measure, in pilot/observational study, panels of circulating     proteins in real time at the onset of neutropenic fever/infection in patients with acute or     chronic leukemias undergoing chemotherapy or other biologic treatment. And to generate     preliminary trend results in panels of circulating proteins longitudinally during the period     of neutropenia and to correlate those values to clinical/laboratory data and patient     outcomes.   "
251252|NCT01144806|"     This project is being conducted with an aim to find out energy expenditure, body composition     and recovery rates in children with severe acute malnutrition (SAM) receiving community-based     nutritional rehabilitation therapy   "
251253|NCT01144819|"     Background:      Dual antithrombotic treatment with aspirin and clopidogrel is recommended in patients with ST     elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention     (PCI). The European Society of Cardiology (ESC) Guidelines recommend a bolus dose of aspirin     of 250-500 mg and a 600 mg bolus dose of clopidogrel as soon as STEMI is suspected. Studies     have shown that more newly produced platelets are present in the acute phase of STEMI, and it     is likely that these immature platelets are haemostatically more active and might be of     importance in thrombus formation.      The enhanced platelet reactivity may reduce the effect of aspirin and clopidogrel in the     acute phase of STEMI compared to measurements made in the same patients 3 months after     primary PCI.      Aim:      This study aims to compare platelet response to aspirin and clopidogrel in the acute phase of     STEMI with the platelet response in the same patients 3 months after STEMI .      Design:      This study is an observational follow-up study.      Materials and methods:      46 patients with STEMI referred to primary PCI at Aarhus University Hospital, Skejby will be     included in the study. A total of 3 blood samples are obtained in the acute phase of STEMI:     Prior to primary PCI (Blood sample 1), at 4 hours (Blood sample 2) and at 12 hours (Blood     sample 3) after administration of loading dose aspirin and clopidogrel. When patients are in     a stable phase 3 month later, a final blood sample is taken (Blood sample 4). The blood is     analyzed 30 minutes after withdrawal of blood by the platelet aggregation test Multiplate®     aggregometry (agonists: Collagen, arachidonic acid and adenosinediphosphate) and VerifyNow®     arachidonic acid and P2Y12 aggregometry. Platelet count, volume and the immature platelet     fraction (IPF) will be measured using Sysmex® flowcytometry.   "
251254|NCT01144832|"     Purpose:      To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the     H1-receptor antagonist ebastine.      Design:      Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment     with ebastine 20mg once daily or placebo (1:1 randomization).      End points:      End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which     will be evaluated with a barostat test.   "
251255|NCT01144845|"     Pain that persists after the healing of a surgical wound has previously been described as an     important, but often unrecognized clinical problem. Persistent postsurgical (chronic     postoperative pain) is the consequence of either ongoing inflammation or more common     neuropathic pain as a result of surgical damage to peripheral nerves.      Previous studies have shown that chronic pain is a frequent and serious complication     following thoracic surgery. However, the prevalence of chronic pain following both     thoracoscopy and anterior thoracotomy in patients with pulmonary malignancies is poorly     characterized and the impact of this pain on patients' lives remains unclear. Thus, this     study aims to investigate the prevalence of chronic pain following thoracoscopy or anterior     thoracotomy, and the severity and impact of persistent post-surgical pain on daily life.      This study is working with several hypotheses: 1.) persistent postsurgical pain following     lung cancer surgery is predominantly of neuropathic nature and the presence of neuropathic     symptoms increases the severity of postsurgical pain and reduces the patient's quality of     life, 2.) the prevalence of chronic pain is reduced over time, and 3.) less invasive thoracic     surgical interventions reduces the risk of the development of chronic pain.   "
251256|NCT01144858|"     The purpose of this study was to determine whether left atrial appendage flow velocity, as     determined using trans esophageal echocardiography (TEE), predicts the outcome after catheter     ablation of persistent Atrial fibrillation( pAF).   "
251278|NCT01145144|"     The aim of this study was to evaluate the effect of dehydroepiandrosterone supplementation on     in vitro fertilization performance and outcome among poor-responder patient.   "
251258|NCT01144884|"     The annual incidence of neck pain has been reported to be 14.6%. Other studies outline a wide     disparity in the lifetime incidence of neck pain ranging from 22% to 70%. Numerous treatment     options exist for the management of neck pain however, there is limited evidence to support     which interventions are most effective. Exercise based interventions are commonly used in the     treatment of patients with neck pain however; it is not clear which patients are most likely     to benefit from this type of treatment. The purpose of this project is to develop a clinical     prediction rule (CPR) to identify which patients with neck pain have a greater probability of     benefiting from a standardized program of education and exercise. Ninety (90) patients     referred to physical therapy will undergo a standardized examination to assess potential     predictor variables. Upon completion of the examination a standardized treatment program of     education and exercise will be administered regardless of examination findings. Self report     measures will be administered on the initial examination and on follow up visits at 2, 4, and     6 weeks. A questionnaire and outcome measures will be also mailed out 6 months after     initiation of treatment to assess long-term change. Once the treatment plan is completed,     patients will be classified as having either a successful or non-successful response.     Subjects which rated their perceived recovery on the Global Rating of Chance (GROC) as a     very great deal better, a great deal better, quite a bit better, or moderately better     (i.e., a score of +4 or greater) will be categorized as having a successful outcome. The     primary endpoints to determine the outcome will be analyzed at 6 weeks and 6 months. The     result of this study will assist physical therapists to identify sub-groups of patients     likely to benefit from a program of education and exercise. The categorization of patients in     groups based on beneficial treatments may help to provide improved outcomes.   "
251259|NCT01144897|"     One purpose of this research study is to examine if a special type of imaging test, a     positron emission tomography (PET) scan using the radioactive material [C-11] acetate, will     be helpful in detecting prostate cancer lesions in subjects with castrate-resistant prostate     cancer. This PET scan will be combined with a computed tomography (CT) scan taken during the     same imaging session. The other purpose of the PET-CT scan using [C-11] acetate (PET Acetate     Scan) is to assist in identifying who is responding to the treatment (docetaxel     chemotherapy).   "
251260|NCT01144910|"     The aim of investigator´s clinical trial is to investigate 52 patients aged three to five     years with viral-induced asthma and 52 patients aged three to five years with allergic     asthma. Over a time-span of 5 years the investigators will explore lung function and     bronchial responsiveness. The investigators plan to evaluate long-term clinical history of     moderate to severe bronchial hyperresponsiveness in preschool children with asthma. Therefore     factors like atopy in children, parental atopy and bronchial hyperresponsiveness will be     explored.   "
251261|NCT01144923|"     The main objective of this study is to determine whether interventional treatment (i.e.     epidural steroids), conservative therapy, or the combination, is superior for cervical     radiculopathy. One hundred and sixty eight patients with radicular neck pain will be     randomized in a 1:1:1 ratio to receive either cervical epidural steroid injections (CESI),     non-interventional management with physical therapy and medications, or a combination of the     two. The first follow-up visit will be at 1-month. In patients who obtain some benefit but     continue to report significant pain, either a 2nd CESI can be done, the patient's medications     can be adjusted, or both in the combination group. Those patients who fail to obtain any     benefit will exit the study to receive another treatment or alternative care. The second     follow-up visit will be at 3-months. Similar to the 1-month follow-up, the doctor may elect     to change nothing in patients who are satisfied, adjust medications, schedule the patient for     another CESI, or do both in the combination group. Patients who fail to obtain any benefit     can exit the study to receive alternative treatment. The final follow-up visit will be at 6     months.   "
251262|NCT01144936|"     The purpose of this study it to evaluate the safety and tolerability of VX-985 in HCV     subjects. This study will also evaluate the antiviral activity and pharmacokinetic profile of     VX-985.   "
251263|NCT01144949|"     The purpose of this study is to assess if patients treated with silodosin will have a higher     spontaneous passage rate of their ureteral stone than those treated with placebo.   "
251264|NCT01144962|"     In a dose escalation study we will determine the safety and preliminary efficacy of     allogeneic bone marrow mesenchymal stem cells (bmMSCs) in the induction of response for     active fistulizing Crohn's Disease (CD).   "
251265|NCT01144975|"     The study hypothesis is that XOMA 052 is likely to improve glycemic control in subjects with     Type 2 Diabetes Mellitus.      The purpose of this study is to determine whether XOMA 052 improves glycemic control in     subjects on Metformin monotherapy whose diabetes is still not adequately controlled.   "
251266|NCT01144988|"     Malignant glioma are the most common and aggressive primary brain tumors in adults. Despite     advances in multimodal treatment including surgery, radiation and chemotherapy, most patients     have a dismal prognosis of 9-15 months (Stupp et al., NEJM 2005).      A major reason for the aggressiveness of malignant glioma is a pronounced tumor     neovascularization, mainly driven by the vascular endothelial growth factor (VEGF) and its     receptors. The therapeutic monoclonal antibody Bevacizumab (Avastin®) inhibits the VEGF     pathway by binding the VEGF ligand. In Magnetic Resonance Imaging (MRI) this treatment     reduces contrast enhancement by restoring both, the blood-brain-barrier and the destabilized     vessel integrity. Furthermore, it raises the sensitivity of co-administered chemotherapeutics     such as Irinotecan. In conclusion, anti-angiogenic therapy leads to the problem that the     routinely used MRI techniques cannot distinguish anti-vascular effects from true anti-tumor     effects.      The study hypothesis of the clinical trial part is that in 35% of malignant glioma patients     Avastin / Irinotecan chemotherapy results in objective tumor responses assessed by standard /     functional MRI and FET- /FLT-PET neuroimaging. The study hypothesis for the translational     study part is that the expression of the molecular targets of Avastin and Irinotecan in     malignant glioma tissue ( = tumor and vascular cells) are predictive for Avastin / Irinotecan     therapy induced treatment response measured by functional MRI and FET- / FLT-PET imaging.   "
251267|NCT01145001|"     The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement     therapy when used in combination with the contingency management (CM) + cognitive behavioral     therapy intervention. Subjects will be randomly assigned to receive either a nicotine     transdermal patch or a placebo patch as well as being randomly assigned to receive either CM     or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that     subjects receiving both active nicotine patch and CM will have higher rates of abstinence     from tobacco than subjects in the other groups.   "
251268|NCT01145014|"     As a transition from preclinical investigations to clinical development in this     first-in-human trial, safety, tolerability, and pharmacokinetics of BI 660848 will be     assessed in human male volunteers using single rising oral doses in order to provide the     basis for a potential ongoing clinical development of BI 660848 in the indication of     neuropathic pain.   "
251269|NCT01145027|"     Forty healthy volunteers will undergo two nailfold-videocapillaroscopy exams with a 10-minute     interval between them, after an 10-h overnight fast in a temperature controlled room. The     subjects will be randomized in two groups: one will receive a sensorial stimulus during the     interval (stimulus group - SG) and the other will receive no stimulus (control group - CG).     The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma,     composed by favorite food items previously related by the individual for this meal. The meal     will not be offered for immediate intake, it will be placed in front of the volunteer for     perception of the smell and taste.      Baseline microvascular parameters will be compared to the results after the interval. The     investigators hypothesize that the SG will have greater capillary recruitment due to a     possible effect of physiologically secreted insulin provoked by the sensorial stimulation     (cephalic phase of insulin secretion).   "
251270|NCT01145040|"     The NOMOTHETICOS study is a unicentric cross-sectional study for a quantitative analysis of     feedback-inhibition in the thyrotropic homeostatic control. Structural parameters are     obtained in vivo from open-loop analysis in patients with disconnected feedback, i.e. with     overt thyroid dysfunction or full dose substitution therapy with levothyroxine.   "
251271|NCT01145053|"     To investigate safety and effectiveness information on the use of Tiotropium Respimat for     long time of period in daily practical clinical circumstances, and to obtain proper drug use     information.   "
251272|NCT01145066|"     This study will compare how well a combination of borage and echium oils will reduce     inflammation compared to fish oils and placebo oil in subjects that are diabetic or have     metabolic syndrome.   "
251273|NCT01145079|"     Drug-eluting stents (DES), markedly reducing the neointimal hyperplasia after stent     implantation compared with bare-metal stents (BMS), have improved angiographic and clinical     outcomes in the complex lesions and patients with high risks. However, currently, the fatal     events related with stent thrombosis still occur and are the major limitation of the use of     DES. Especially, late or very late thrombosis after DES implantation is an uncommon but     life-threatening fatal complication presented with sudden death or myocardial infarction (MI)     causing heart failure. The most powerful predictor for stent thrombosis is the     discontinuation of clopidogrel. In consideration of current data regarding stent thrombosis     and clinical situation of discontinuation of antiplatelet, zotarolimus-eluting stent (ZES)     [Endeavor®, Medtronic Vascular, Santa Rosa, CA] might be anticipated to be safer than other     DES during the long-term follow-up owing to healthy endothelialization. Endeavor® stent was     consists of zotarolimus, thin-strut, cobalt-chromium alloy stent platform (DriverTM stent;     Medtronic Vascular, Santa Rosa, CA), and phosphorylcholine coating. The ENDEAVOR II study     demonstrated clinically and statistically significant improvement in all of study endpoints,     including a 47 percent reduction in the primary endpoint of target vessel failure (TVF). In     addition, the ENDEAVOR II trial showed a 0.5 percent rate of stent thrombosis at 30 days -     with no late thrombosis beyond 30 days and no late stent malapposition. Because     reendothelialization after ZES implantation may occur within 3 months, 3-month dual     antiplatelet therapy is recommended in many clinical trials and real world practice. Shorter     maintenance of dual antiplatelet therapy might minimize the risk for stent thrombosis in     cases of discontinuation of antiplatelet and prevent waste medications and bleeding     complications related with dual antiplatelet therapy. However, there have been no     non-inferior or superior data of ZES considering all these circumstances. Therefore, the     investigators hypothesize that ZES with 3-month dual antiplatelet therapy may be safe and     beneficial in patients with coronary artery disease during follow-up than other DES, in spite     of higher late lumen loss. To test this hypothesis, the investigators will perform a     multi-center, randomized, prospective trial aimed at demonstrating the efficacy of the ZES     versus other DES in patients with coronary artery disease in real world practice.   "
251274|NCT01145092|"     Life style intervention including diet and exercise is the recommended strategy for     prevention of type 2 diabetes mellitus (T2DM). First-degree relatives of patients with type 2     diabetes mellitus have an increased risk of insulin resistance and a lifetime risk of     developing type 2 diabetes of 40%- 80%. Poor physical fitness is a strong indicator of an     increased risk of developing diabetes.      Long-term endurance exercise training has been shown to increase insulin sensitivity in     sedentary young and elderly individuals, first degree relatives of patients with Type 2     diabetes, glucose intolerant obese, or Type 2 diabetic humans. In type 2 diabetic patients,     non-diabetic individuals with IGT and sedentary adults after exercise training of different     intensity, different duration and different frequency an increase of insulin sensitivity was     found.      However, despite the vast knowledge concerning beneficial effects physical activity for the     prevention of T2DM (and many other chronic metabolic disorders) to date wide ranging     strategies have not been realized satisfactory. Regardless of age, ethnicity, sex or health     status the lack of time is the primary reason for the failure to exercise on a regular basis     (or is stated as primary reason). Therefore the investigators aimed at investigating whether     a controlled endurance/resistance training twice a week over 6 month might be beneficial for     healthy, non obese, first degree relatives with T2DM. Therefore the investigators measure     parameters associated with the prevention of T2DM like insulin sensitivity, flux through     fATPase and fCK, intramyocellular and hepatocellular lipids.   "
251275|NCT01145105|"     Low back pain ( LBP) is a significant health problem which affects about 70%-80% of the     population during the course of their life . The majority of LBP is resolved within 3 months;     however, up to 40% of LBP becomes chronic. One subgroup of chronic LBP is patients with     sciatica. Sciatica is characterized by radiating pain to the buttock and lower limb, with or     without low back pain.      It has been shown in the upper limb that by positioning the contra-lateral arm in tension the     investigators actually reduce tension in the ipsilateral arm. Patients, who present with     symptoms like sciatica, can benefit from this maneuver (neural dynamics techniques) that     reduces tension through the contra-lateral leg.      Working Hypothesis: Compared with a placebo maneuver of the upper limb, the neural dynamics     techniques will result in better rehabilitation of individuals with radicular LBP.   "
251276|NCT01145118|"     Plantar Fasciitis (PF) is the most common foot condition treated by healthcare providers,     striking approximately 2 million Americans each year. Nevertheless its causes are still not     known. The risk factors for PF are known and the diagnosis, which is based on clinical     assessment, is relatively simple. Still most of the treatments for PF focus on short term     symptoms relief instead of prevention or reduction of recurrence.      Physical therapy treatment that focuses on reducing the symptoms for the long run and     prevention, should include outcome measures, which if found to be reliable, will make the     diagnosis clearer. Diagnosis based on reliable clinical and functional measures will assist     the physical therapist to understand the major deficiencies of the patient, and accordingly     to help him to make the right decision in choosing treatment. Also comprehensive knowledge of     the characteristics of PF may enable selection of appropriate preventive measures.   "
251277|NCT01145131|"     Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is     to test whether meat structure plays an important role in protein digestion, to maximise the     amino acid availability and to stimulate the muscle protein growth in elderly people.   "
251282|NCT01145196|"     Background:      - Plaquenil (hydroxychloroquine) is an anti-inflammatory drug that is used to treat some     autoimmune diseases such as lupus and rheumatoid arthritis. This drug can damage the retina     by causing a condition called plaquenil-induced retinal toxicity, which may lead to vision     loss. However, most people taking plaquenil do not develop this problem. Researchers are     interested in studying whether differences in a person s genes explain why some people     develop plaquenil-induced retinal toxicity while others do not.      Objectives:      - To investigate possible correlations between certain genes or genetic mutations and     plaquenil-induced retinal toxicity.      Eligibility:        -  Individuals at least 18 years of age who have previously used plaquenil.        -  Both individuals who have and have not developed plaquenil-induced retinal toxicity will          be eligible for this study.      Design:        -  The study requires one or two visits to the National Eye Institute or an outpatient          study clinic over a maximum 2-year period.        -  Participants will provide a personal and family medical history, and will have a full          eye examination.        -  Participants will also provide blood samples for testing.        -  No treatment will be provided as part of this protocol.   "
251283|NCT01145209|"     Background:      - Ofatumumab has been approved by the U.S. Food and Drug Administration to treat patients     with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not     responded to standard chemotherapy. Ofatumumab is a substance that recognizes specific types     of white blood cells called B-lymphocytes, which become cancerous in CLL/SLL. Ofatumumab     attaches to a molecule called CD20, which is found on the surface of B-cells, and destroys     them. Previous studies have shown that ofatumumab can decrease the number of B-cells in     patients with CLL/SLL who have been treated with chemotherapy, but more research is needed to     determine it if can also be used to treat patients with previously untreated CLL/SLL.      Objectives:      - To determine a safe and effective dose of ofatumumab, along with chemotherapy, to treat     chronic lymphocytic leukemia or small lymphocytic lymphoma.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with CLL or SLL that has not     been treated with chemotherapy.      Design:        -  Eligible participants will be screened with a physical examination, blood samples, lymph          node and bone marrow biopsies, and imaging studies.        -  Participants will be separated into two groups: all participants will receive ofatumumab          and fludarabine, and some participants will be selected to also receive cyclophosphamide          (based on the results of certain blood tests).        -  Participants will receive the study drugs (ofatumumab and fludarabine, and optional          cyclophosphamide) by infusion for a maximum of 6 days, followed by 21 days off the drug.        -  Participants will have six cycles of treatment according to a schedule set by the study          doctors, and may have their dose levels adjusted if side effects develop.        -  Participants who have disease remaining after six cycles will receive additional          ofatumumab every 2 months, starting 2 months after the end of the sixth cycle and          continuing for a total of four doses, before entering the follow-up phase of the trial.          Participants who do not have residual disease after six cycles will not receive          additional therapy, and will immediately enter the follow-up phase of the trial.        -  Participants will have a follow-up exam every 2 to 4 months for 2 years after the end of          treatment, and then as required by the study doctors for as long as the study remains          open. These visits will involve a full medical examination, blood samples, lymph node          and bone marrow biopsies, and imaging studies.   "
251284|NCT01145222|"     The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056     compared with midazolam to maintain suitable sedation levels in patients undergoing     colonoscopy.   "
251285|NCT01145235|"     A Registry to monitor long term safety in female subjects after treatment with Macrolane     VRF20 and/or MacrolaneT VRF30 in the breasts.   "
251286|NCT01145248|"     Cholangiocarcinomas (CCCs) are malignant tumors arising from the biliary epithelium. CCCs are     characterised by a high mortality and the only curable therapy is complete tumor resection,     if feasible, or in some cases liver transplantation. Since surgery for CCC is a procedure     associated with a high mortality itself it needs to be ascertained that an accurate     preoperative diagnosis has been established. However, it often appears to be difficult to get     a preoperative pathological diagnosis, since it is difficult to obtain tumor specimens using     cytologic brushings, biopsy forceps, bile aspiration or endoscopic ultrasonography     guided-fine needle aspiration. This is reflected by a nearly 100% specificity but low     sensitivity rates.      The aim of this study is to compare a new method of biliary biopsy using a double-balloon     enteroscopy (DBE) forceps to enable a safe and reliable tissue specimen collection within the     proximal biliary tract with cytology brushings in patients with suspected malignant proximal     biliary strictures.   "
251287|NCT01145261|"     The current study will focus on two phases of anxiety process: Generating Anxiety (reported,     direct and physiological) and Emotional Regulation Strategies (Reappraisal, Mindfulness,     Expressive Suppression and Rumination). The claim is that better understanding of these     phases in relation to CBT treatment will lead to better understanding of remission in anxiety     and to better treatments in the future. Objectives: To understand the relations between the     four strategies of emotional regulation to anxiety disorder hence to understand the relation     between these strategies to treatment effectiveness of children with anxiety disorder.     Methods: In phase one, clinically anxious adolescence before treatment (N=40) and healthy     controls (N=40) will be compared. Anxious adolescence are expected to have significantly     higher levels of physical arousal and will use spontaneously more expressive suppression and     rumination and less reappraisal and mindfulness then the healthy controls. In phase two,     clinically anxious adolescence (N=40) before and after 8-12 weeks of CBT treatment will be     compared. More specifically remitted patients will be compared with partially remitted     patients. Remitted patients are expected to show better improvement in the physical arousal,     then partially remitted. More, Decrease in levels of anxiety will be mediated by the four     emotional regulation strategies, and the efficiency of using the Reappraisal will be higher.   "
251288|NCT01145274|"     To know the blood level of allopurinol in chronic kidney disease (CKD) patient.   "
251289|NCT01145287|"     The main purpose of this study is to assess the impact of the diagnosis of celiac disease on     general health, healthcare resource utilization, quality of life and lifestyle. We     hypothesize that diagnosis and subsequent dietary treatment may have positive impact on these     variables.   "
251290|NCT01145300|"     Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and     mortality worldwide and is characterized by fixed airflow obstruction. The cornerstone of the     disease is chronic inflammation leading to narrowing of the small airways and thus impairment     of lung function. Compared to spirometry, the single breath N2-washout-test is more sensitive     to identify the regional heterogeneity of bronchial airflow obstruction in the small airways.      The aim of this study is to evaluate whether there is a correlation between the sbN2-test,     markers in exhaled air and the inflammatory cells in the small airways.   "
251350|NCT01146119|"     This is a multi-center, randomized, two stage, double-blind, placebo-controlled     administration study comprising 200 healthy participants.   "
251352|NCT01146145|"     This is a randomised, controlled, double blinded study comparing in the postoperative setting     the analgesic efficacy, the safety and the cost in two groups of patients receiving in the     postanesthesia care unit either intravenous morphine titration alone or intravenous morphine     titration combined to ketamine.   "
251296|NCT01145391|"     The goal of this project is to use health information technology and team-based care in novel     ways to support the establishment of a Patient-Centered Medical Home model of care aimed at     improving the diagnosis and management of hypertension. Compared with patients who receive     usual care, patients who receive intervention will have a lower average systolic blood     pressure 9 months after randomization.   "
251297|NCT01145404|"     Combining Erb inhibitors, such lapatinib, and TS inhibitors, such as capecitabine, may be a     beneficial contribution to current treatment paradigms since preclinical data suggest that     lapatinib alone can decrease TS mRNA and is synergistic with capecitabine in some cell lines,     which may contribute to clinical benefit. The study described in this protocol has been     designed to establish the anti-tumor activity of Lapatinib with or without capecitabine in     the treatment of Her2 overexpressing metastatic gastric- and gastro-esophageal cancer, and to     search for molecular correlates that may be associated with response to this compound.      The majority of patients with metastatic gastric and gastro-esophageal cancer undergo     first-line combined chemotherapy (e.g. platin derivates and fluoropyrimidines, sometimes     combined to a taxane), but the role of second-line chemotherapy has not yet been defined.     Therefore, progression during or shortly after first-line chemotherapy is a medical condition     no standard medical approach exists. The overexpression of EGFR and Her2 in gastric and     gastroesophageal cancer make these indications prime candidate for treatment with the dual     ErbB1/2 tyrosine kinase inhibitor (TKI) Lapatinib.   "
251298|NCT01145417|"     This study examines the safety of pregabalin over a 6 month period in patients with     neuropathic pain associated with HIV infection as an extension of another trial that tests     the efficacy of pregabalin.   "
251299|NCT01145430|"     This phase I trial studies the side effects and the best dose of veliparib when given     together with pegylated liposomal doxorubicin hydrochloride in treating patients with ovarian     cancer, fallopian tube cancer, or primary peritoneal cancer that has come back after a period     of improvement, or breast cancer that has spread to other parts of the body. Veliparib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as liposomal doxorubicin hydrochloride, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Giving veliparib together with liposomal doxorubicin     hydrochloride may kill more tumor cells.   "
251300|NCT01145443|"     The care of critically ill patients in Intensive Care Units (ICUs) is an important part of     modern health care systems. However, ICU care suffers from similar problems as the rest of     the health care system. Powerful arguments support the concept that most of problems in     complex systems, such as ICUs, relates to flaws in institutional systems and processes that     hinder the ability of individuals to perform their jobs well. To fix these problems, the     defective systems and processes must be redesigned in ways that make it easy for people to do     their job well, and hard to make mistakes. Altering the structure of ICU care for the purpose     of improving ICU performance is an example of Organizational Systems Engineering,     alternatively called Total Quality Management.      Another serious problem in ICU care is that after 2007 there will be a increasing shortage of     physicians specializing in the care of the critically ill (Intensivists), with a 35%     shortfall by 2030. One contributor to this shortage is that Intensivists retire at a younger     age than do physicians in general, and often curtail their care of critically ill patients     even before they retire. It is likely that the emotional and physical demands of this career     choice leads Intensivists to burn out and leave the field prematurely. For these reasons it     is important to find ways to make working as an Intensivist more sustainable so that the most     experienced practitioners will continue in the field up to a normal retirement age.      The way in which groups of Intensivists organize themselves to provide care in an ICU is     highly variable. One potentially important way in which Intensivist staffing differs is in     the degree of continuity of care. The more days in a row that the same physician cares for a     patient the greater the continuity of care. While it is generally held that a higher     continuity of care results in better care and better outcomes for patients, in fact there are     no studies addressing this issue. On the other side of the coin however, it seems likely that     working many days in a row increases the physical and emotional burdens on the Intensivist,     increasing job distress and job burnout over time.      A common pattern of Intensivist staffing, in which continuity of care is reduced, is when the     Intensivist who is caring for ICU patients during the weekdays has the weekend off, during     which one of his/her partners provides cross-coverage. While it is reasonable to     hypothesize that cross-coverage would lead to inefficient patient care, at the same time it     may reduce the burdens on the Intensivists.      This purpose of this study is to investigate the effects of weekend cross-coverage on both     ICU patients and on Intensivists. This will be a multicenter study performed in 4 member     institutions of the Midwest Critical Care Consortium: The University of Toledo, MetroHealth     Medical Center, Ohio State University, and Indiana University. Five adult medical ICUs from     the six institutions will participate in this study, with two ICUs from the Ohio State     University site.      To answer the research questions, each participating ICU will alternate between two common     models of Intensivist staffing. In both models an Intensivist is responsible for ICU care for     14 days. In the Continuous model, a single Intensivist will be responsible for all 14 days.     In the Discontinuous model, both weekends during the 14 days will be cross-covered by a     colleague. Continuity of care is higher in the Continuous model, which has 2 physician     transitions over a 4 week period, while the Discontinuous model has 8 transitions per 4     weeks. Each participating ICU will use one model for 12 weeks, then switch to the other model     for 12 weeks, and finally revert back to the first model for the final 12 weeks of this 36     week study. To address problems of historical controls, seasonal differences, and to increase     comparability of groups, the participating ICUs have been randomly assigned to begin the     study either with the Continuous or Discontinuous model.      Comparisons will be made between the two scheduling models in: (1) patient outcomes,     specifically hospital mortality rate, ICU length of stay, and hospital length of stay, and     (2) Intensivist outcomes, specifically job distress, job burnout, and the balance between     work and home life.      Since there is currently nothing known about whether weekend cross-coverage influences     medical care, both models of care are common in ICUs. Thus the investigators expect that the     findings of this study will have general relevance. While the patients admitted to the     participating ICUs during this study would not be expected to benefit from this     investigation, the results derived are expected to enable policy makers to make     evidence-based decisions about this important aspect of ICU physician staffing and thus     improve the performance and/or cost-effectiveness of ICU care, benefiting future ICU     patients, and society.   "
251301|NCT01145456|"     This phase I trial is studying the side effects and best dose of gamma-secretase inhibitor     RO4929097 when given together with gemcitabine hydrochloride in treating patients with     advanced solid tumors. Gamma-secretase inhibitor RO4929097 may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving gamma-secretase inhibitor     RO4929097 together with gemcitabine hydrochloride may kill more tumor cells.   "
251302|NCT01145469|"     RATIONALE: Studying samples of DNA in the laboratory from patients who received     fludarabine-based treatment may help doctors learn more about the effects of fludarabine on     cells. It may also help doctors understand how well patients respond to treatment.      PURPOSE: This research study is studying DNA samples from patients with chronic lymphocytic     leukemia previously treated with fludarabine-based therapy.   "
251303|NCT01145482|"     The study described in the present application will test the hypothesis that insulin mediated     facilitation of memory in Alzheimer's disease (AD) is achieved through enhanced glutamatergic     neurotransmission due to improvements in cerebral glucose metabolism. The effect of a single     dose of intranasal insulin on memory and cerebral glutamate concentrations in adults with     mild AD or amnestic mild cognitive impairment (aMCI), the presumed prodromal phase of AD will     be studied. Successful completion of this study may set the stage for a larger-scale     treatment trial of intranasal insulin for adults with memory disorders. However, the use of     insulin in this manner at this point in time is purely experimental.   "
251304|NCT01145495|"     This phase II trial studies how well lenalidomide and rituximab work in treating patients     with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.     Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in     different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab,     may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide     together with rituximab may kill more cancer cells.   "
251305|NCT01145508|"     This randomized phase II trial studies how well docetaxel and prednisone with or without     vaccine therapy works in treating patients with hormone-resistant prostate cancer that has     spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and     prednisone, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from     an antigen may help the body build an effective immune response to kill tumor cells. It is     not yet known whether docetaxel and prednisone are more effective with or without vaccine     therapy in treating prostate cancer.   "
251306|NCT01145534|"     The purpose of this study was to investigate whether the infusion of a medicinal plant     (Cissus verticillata L.) would be effective in reducing glucose levels in blood and saliva of     type 2 Diabetes patients.   "
251351|NCT01146132|"     The study will provide evidence of eating habits and physical activity in cerebrovascular     patients in Luxembourg and of the degree to which these habits may be changed acutely (after     one month) and in the long run (after 4 months) by intensive counselling. Furthermore the     influence of intensive counselling and of the consumption of red wine on cerebrovascular risk     factors, cognition, and on surrogate parameters for stroke will be assessed.   "
251353|NCT01146158|"     Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM),     involves retrieving all breast related nodes while leaving intact the main lymphatic drainage     chain of the upper limb. This represents a new surgical technique that is the focus of recent     surgical interest.   "
251354|NCT01146171|"     The purpose of this clinical study is to evaluate the safety and tolerability of CT-322     monotherapy to determine the recommended dose for phase II and subsequent studies   "
251307|NCT01145547|"     Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.      Objective: The aim was to determine the impact of low vs high glycemic index (GI) on     post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous     glucose monitoring.      Design: Seven adult subjects with type 1 diabetes participated in two experiments, each     consisting of two meals each. In one experiment, both meals had a low GI; in the other, high     GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat     content. Each subject received his usual pre-prandial insulin dosage, followed by a     continuous subcutaneous basal insulin infusion for the remainder of the experiment.     Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded     every 5 minutes.   "
251308|NCT01145560|"     The primary purpose of this study to evaluate the effect of two different doses of AZD9773     (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the     start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are     already receiving appropriate standard of care treatment for sepsis.   "
251309|NCT01145573|"     Women between the ages of 18 and 45 are needed for a study that looks at the effect of     calcium supplementation on bone health during pregnancy in black and white women. Study     subjects will be divided into two groups. Each group will take 2 study supplements each day,     the supplement will be calcium or placebo (a pill without calcium). The study involves five     visits to the Children's Hospital of Oakland Research Institute; each visit will be 1-2 hours     in length. There are 3 study visits during pregnancy and 2 in the first year after delivery.     At each visit you will have your blood drawn and be asked questions about what you eat and     what type of activities you do. At visit 16 and 36 weeks and 4 and 12 months postpartum you     will have your bone density measured. You will be paid $240 for completing the study.   "
251310|NCT01145586|"     The primary objective is to determine the compared clinical efficacy of Lactase Eurofarma     (test drug), showing non-inferiority to Lactaid® (comparative drug) in the supportive     treatment of lactose intolerance and to assess the safety and tolerance of Lactase Eurofarma     (test drug) in the supportive treatment of lactose intolerance.   "
251311|NCT01145599|"     The purpose of this study is to identify eyes that show worsening and disease progression     (progressor phenotypes).   "
251312|NCT01145612|"     The purpose of this study is to evaluate the efficacy of Losartan versus Atenolol in the     progression of aortic dilatation in patients with Marfan syndrome.   "
251313|NCT01145625|"     This is a year-long clinical trial to evaluate the effectiveness and safety in women with     Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation     applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.      This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to     evaluate if there is a change in the number of hairs in the area being examined after using     the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).      This trial will determine if the benefit of using either study product outweighs the risks.   "
251314|NCT01145638|"     The purpose of this study is to compare the efficacy and safety of intravenous iron therapy     with oral iron therapy in patients with cancer and chemotherapy induced anaemia.   "
251315|NCT01145664|"     The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines     for severe hand-foot-mouth disease.   "
251316|NCT01145677|"     This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with     alcoholism   "
251317|NCT01145690|"     Social anxiety disorder (SAD) is one of the most prevalent anxiety disorders in the western     world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the     largest empirical support. However, the availability to CBT is very limited in Sweden due to     lack of therapists with proper training. Therefore it is important to evaluate alternative     forms of treatment that are more time efficient. One of these methods is Internet based     self-help therapy, which has proven to be an effective treatment for social anxiety disorder.      In this study, the investigators aim to conduct a follow-up assessment five years after     completed Internet-based CBT. Participants received treatment within the context of a     randomised controlled trial conducted in 2005. Thus, in the present study there will be no     treatment interventions, only assessment.   "
251318|NCT01145703|"     The purpose of this study is to examine the effects of Vitamin D supplementation on the     reasons (mechanisms) underlying the development of type 2 diabetes, metabolic syndrome (high     blood pressure, cholesterol, diabetes, body weight/obesity), muscle weakness and wasting     (sarcopenia), and impaired physical function (poor balance and walking) associated with     vitamin D deficiency and osteopenia/osteoporosis (bone loss). The investigators obtain     vitamin D through our diet and sunlight, and its conversion to active vitamins in the liver     and kidneys promotes the intestinal absorption of calcium and regulation of bone growth.     Therefore, vitamin D deficiency has been known for years to lead to weakened bones     (osteopenia and osteoporosis). However, more recently, studies show vitamin D deficiency is     associated with a number of other diseases, including type 2 diabetes, muscle weakness,     frailty, and the metabolic syndrome. It has also been associated with cognitive impairment.     Diabetes affects multiple organ systems including the heart, kidneys, musculoskeletal and     nervous system. The possibility that vitamin D deficiency is linked to the development of     type 2 diabetes, metabolic syndrome, muscle weakness and wasting (sarcopenia) and     osteopenia/osteoporosis, and that vitamin D supplementation decreases the risk for these     diseases, provides a relatively easy/accessible and inexpensive model of preventive therapy     to decrease the incidence of these diseases. In addition, it is likely that genetic     (inherited) factors play a role, but the relationship of these genes to these metabolic     abnormalities have not been elucidated. Understanding the role of Vitamin D in health will     allow us to translate these findings into therapy.   "
251319|NCT01145716|"     The purpose of this study is to describe and stage lesions of the triangular fibrocartilage     complex (TFCC) in association with distal radius fractures. 20 patients with dorsally     dislocated AO type A fractures of the distal radius with sufficient displacement (based of     cadaveric data) will be included. After stability testing and wrist arthroscopy. The TFCC is     explored through a volar incision and injuries were documented and repaired from this     approach.   "
251378|NCT01146483|"     This is a single-center, randomized, 2-period, 2-sequence, cross-over study.   "
251320|NCT01145729|"     1. To do formative work with healthcare providers, clinic staff and parents to develop a          protocol for a clinic system to routinely collect blood from children at risk of SHS          exposure conduct laboratory testing for tobacco toxicants, document exposure in the          electronic medical record (EMR) and incorporate the biomarker feedback into a parental          smoking treatment plan.        2. To pilot test effects of a clinic system to screen children at risk of SHS exposure with          laboratory testing for tobacco toxicants on provider delivery of tobacco treatment          services (primary outcome).        3. To pilot test effects of a clinic system to screen children at risk of SHS exposure with          laboratory testing for tobacco toxicants on parent smoking behavior (participation in          smoking cessation treatment, smoking cessation and implementation of smoking          restrictions).   "
251321|NCT01145742|"     Many primary care patients, especially in inner-city settings, do not achieve targets for     blood pressure and glycemic control. There is an urgent need to enhance treatment for those     who do not reach goals within the usual clinical care system. We propose to develop a     multi-component intervention grounded in the Chronic Care Model, and sustainable in     resource-challenged settings. Through collaboration with home health nursing and with the use     of home telemetry for feedback and intensification of therapy, we will augment usual clinical     services to improve health outcomes for diabetes patients who have not been able to reach     therapeutic goals. There are three specific aims. First, we will establish a feasible,     practical and sustainable collaborative model between the primary care sites of our     practice-based research network (NYC RING), clinical researchers at the Diabetes Research and     Training Center, and The Montefiore Home Health Organization, integrating the unique     expertise of each of the partners and defining the roles and responsibilities of each.     Second, we will develop and refine the components of the intervention, to include training     primary care providers and home health nurses to integrate the technical, psychosocial and     communication processes for implementation of the intervention. Third, we will assess the     feasibility of the collaborative intervention by implementing the intervention for 25 primary     care patients and obtain preliminary estimates of effectiveness by comparing outcomes to 25     patients receiving usual care. Our proposal includes plans to develop feasible procedures for     data collection, with qualitative and quantitative methods of assessing process and outcome     measures. We will use these preliminary data to revise the intervention and prepare an R18     application to further develop and test the intervention in multiple inner-city primary care     sites serving low-income diabetes patients. This proposal is for secondary prevention of     diabetes complications, targeting a population known for health disparities and a high burden     from this chronic disease.   "
251322|NCT01145755|"     This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in     patients with major depressive disorder.   "
251323|NCT01145768|"     To investigate the safety and tolerability of TC-5214 following oral administration of single     and multiple ascending doses compared to placebo.   "
251324|NCT01145781|"     To evaluate whether single- and double-freeze cryotherapy techniques have similar efficacy in     controlling different grades of cervical intraepithelial neoplasia (CIN), and have similar     side effects and complications.   "
251325|NCT01145794|"     The high prevalence of smoking in adults in many developing countries (e.g. in China, 61%     among men and 7% among women) results in many children being exposed to secondhand smoke     (SHS). Although in 2001 the American Academy of Pediatrics recommended the promotion of     proper smoking hygiene, (i.e. smoking away from the immediate environment of infants and     children), similar recommendations in many developing countries are either scarce or     non-existent. We hypothesize that implementation of a package of smoking hygiene intervention     measures delivered by community health workers (CHWs) will reduce Chinese children's exposure     to SHS and improve their respiratory health.   "
251326|NCT01145807|"     The aim of this study is to establish the efficacy, clinical benefits, and safety of     treatment with TDT 067 for clinically diagnosed distal subungual onychomycosis of the     toenails caused by dermatophytes confirmed by positive mycology.   "
251327|NCT01145820|"     The proposed study will test the following hypotheses:        1. Pre-operative daily dual supplementation with Juice Plus+ (fruit & vegetable) for 11          weeks will result in reduced post-operative morbidity in terms of quality of life, pain          and trismus after 1 week following surgical removal of lower third molars, when compared          to placebo.        2. Pre-operative daily dual supplementation with Juice Plus+ (fruit & vegetable) for 11          weeks will reduce serum markers of oxidative stress, following surgical removal of lower          third molars, when compared with placebo.   "
251328|NCT01145833|"     The purpose of this study is to evaluate whether a home based program can teach parents and     moderately overweight kids who are of 8-12 years old with a BMI% between 85-97%, how to     manage their child's weight. The study uses manuals and involves a short visit to the clinic     every other week.   "
251329|NCT01145846|"     The purpose of this non-inferiority study is to compare the effectiveness of two induction     chemotherapy regimens (cytarabine plus idarubicin [AI] versus cytarabine plus high-dose     daunorubicin [AD]) in AML. The effectiveness will be evaluated in terms of complete remission     (CR) rate.   "
251330|NCT01145859|"     The first study with rivaroxaban in pediatric subjects is a Phase I study, where the     pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to     confirm that the exposure is comparable to adults. This study is a single dose study with     multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism     (VTE) treatment.   "
251331|NCT01145872|"     This research proposal is intended to elucidate the efficacy and mechanisms underlying     Mindfulness Based Cognitive Therapy (MBCT) in a population in remission from recurrent Major     Depressive Disorder (MDD). The first objective of the study is to replicate previous studies'     findings of MBCT's effects on decreasing depressive symptoms and depression relapse rates.     However, this proposal aims to make a novel contribution to the literature by using a     randomized, controlled design, and comparing the effects of MBCT to an active control     condition (ACC). The use of a well-designed ACC will enable us to control for confounding     variables such as social support and expected outcomes, thus allowing us to determine whether     elements specific to MBCT lead to its salutary effects (Aim 1). Previous MBCT studies have     largely relied on self-report measurement methodologies, limiting valid conclusions about the     nature of MBCT. Further, few studies have examined the mechanisms underlying effects of MBCT     on depressive symptoms and relapse. Theoretical considerations and preliminary empirical     evidence suggest emotional, physiological, and cognitive functioning to be promising     mechanisms of MBCT. Therefore, the investigators propose to assess each of these potential     mechanisms of MBCT using self-report, autonomic physiological, and reaction time tasks (Aim     2). Collectively, these aims are expected to strengthen the evidence base for MBCT while     cultivating a scientific model for its effects and mechanisms on decreasing depressive     symptoms and depression relapse rates.   "
251336|NCT01145937|"     Rationale:      Keratoconus is a progressive, non-inflammatory corneal disease in which irregular refractive     properties of the cornea result in loss of visual acuity. Treatment is aimed at improving     vision, principally using (rigid) contact lenses. With progression of the disease     non-correctable refractive abnormalities and/or corneal scars arise. For these advanced     stages of keratoconus, a corneal transplant is the only treatment modality.      New surgical grafting modalities have been developed to create partial thickness grafts,     according to the location of corneal pathology. For keratoconus, transplanting only the     anterior corneal lamellae lowers long-term graft rejection rates. We utilize a method to     enhance the safety of the grafting procedure while better visual outcomes are expected.      Objective:      To investigate the additional value of partial endothelial trepanation (PET) in an anterior     lamellar keratoplasty (ALKP) procedure in terms of efficacy and safety in patients with     keratoconus.      Study design:      A randomized controlled interventional trial      Study population:      Patients over 18 years old with keratoconus in whom contact lens correction is unsuccessful     and who are not suitable for corneal crosslinking.      Intervention:      Patients will be randomly assigned to corneal grafting techniques; partial endothelial     trepanation in addition to an anterior lamellar keratoplasty (i.e. the PET group) or a     regular ALKP procedure.      Study outcomes:      Risk of per-operative perforation. Secondary, factors contributing to treatment safety and     efficacy.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      There is no extra burden or risk associated with participation in this study. All     measurements are part of normal clinical practice. Adequate experience is available with both     surgical techniques. Study participation has no effect on donor selection. If partial     endothelial trepanation (PET) is associated with lower complication rates and better visual     outcomes, this might be beneficial in terms of morbidity.   "
251337|NCT01145950|"     To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator,     Enbrel® 25 mg.   "
251338|NCT01145963|"     Investigators are interested in learning how appetite responds to pasta containing different     amounts of protein and fiber. In this research study, subjects will be asked to eat as much     as they want of pasta containing different amounts of protein and fiber mixtures, thereafter     subjects will describe their feelings of hunger, fullness and desire to eat for 3 hours     afterwards. Subjects will be asked to do this on three separate occasions.   "
251339|NCT01145976|"     The purpose of this study is to reduce the regimen related toxicities and transplantation     related mortality after allogeneic stem cell transplantation in adult acquired aplastic     anemia (AA), the trials of reduced dose of Cy along with fludarabine and ATG were     performed.11-21 The investigators preliminary data of randomized comparison of     cyclophosphamide plus fludarabine versus cyclophosphamide alone in addition to anti-thymocyte     globulin for the conditioning therapy in allogeneic hematopoietic cell transplantation for     bone marrow failure syndrome supports reduced dose of Cy along with fludarabine and ATG.      Conditioning regimen without Cy may reduce RRT because Cy-containing conditioning remains     several RRT such as hemorrhagic cystitis, SOS and graft versus host disease (GvHD). Recently     there were small trials of fludarabine and ATG (Flu-ATG) for the conditioning regimen of     alloHSCT.22-24 These data raised the feasibility of fludarabine and ATG without Cy for     patients with AA.      This new conditioning regimen of Flu-ATG will be compared to standard regimen of Cy- ATG in a     randomized controlled trial.   "
251340|NCT01145989|"     The purpose of this study is to find out whether the new drug AT9283 will slow the growth of     multiple myeloma. Side effects of AT9283 will also be closely monitored.   "
251341|NCT01146002|"     This study is investigating the effect of sustained-release guanfacine (Intuniv) on     language-based learning skills in children age 6-12 who are diagnosed with attention deficit     hyperactivity disorder (ADHD).   "
251342|NCT01146015|"     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in     influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of     these vaccines are required to be involved in ongoing clinical trials and to present the     results to the competent authorities each year. The current study is a phase IIIa clinical     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It     is part of the ongoing clinical trial program for Influvac® and will be done to assess the     immunogenicity and safety and tolerability of next season's trivalent influenza subunit     vaccine in two groups of subjects in good health: subjects aged >= 18 and <= 60 years and     subjects >= 61 years of age (elderly)   "
251343|NCT01146028|"     The purpose of this bioequivalence study is to compare the test Tizanidine Hydrochloride 4mg     tablets of Dr.Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in     healthy adult subjects under fasting conditions.   "
251344|NCT01146041|"     The purpose of this bioequivalence study is to compare the test of Rivastigmine 1.5 mg     Capsules of Dr.Reddy's Laboratories Limited with reference to Exelon 1.5 mg of Novartis in     Healthy Subjects Under Fed Conditions.   "
251345|NCT01146054|"     This multi-institutional trial aims to evaluate the potential benefit and side effects of     adding fractionated stereotactic body radiotherapy/surgery (SBRT) before and after     chemotherapy with gemcitabine for locally advanced pancreatic cancer.   "
251346|NCT01146067|"     This is a bioequivalence study of Rivastigmine 1.5 mg capsules and Exelon Administered as 1.5     mg capsule in Healthy subjects under fasting conditions.   "
251347|NCT01146080|"     Compared with bare metal stents (BMS), both paclitaxel-eluting stents (PES) and     sirolimus-eluting stents (SES) significantly reduce angiographic restenosis and the need for     repeat revascularization in coronary arteries across a broad range of patient and lesion     types. However the increased risk of very late stent thrombosis represents a major concern     for patients treated with both PES and SES. Optical coherence tomography (OCT), a new imaging     technique based on the back reflection of near infrared light, enables real-time, full     tomographic, in-vivo visualization of coronary vessel microstructure. Struts coverage and     vessel response of drug eluting stent (DES) compared to BMS are the most immediate clinical     applications of OCT. Thickness of coverage and strut apposition can be quantified at     micron-scale level with a resolution 10-30 times higher than conventional intravascular     ultrasound (IVUS). The objective of this study OCTEVEREST (Optical Coherence Tomography for     EVERolimus Eluting STent) is to evaluate the long term struts coverage and vessel wall     response (abnormal intraluminal defects, strut malapposition, vessel expansions) to the     PROMUS™ Everolimus Eluting Stent compared to PROMUS ELEMENT™ Everolimus Eluting Stent     implanted for the treatment of stenosis in native coronaries. To investigate the completeness     of struts coverage as well as the proportion of malapposed struts and the neointima     characteristics, high resolution (~ 10 µ axial) intracoronary Optical Coherence Tomography     (OCT) and intravascular coronary ultrasound (IVUS) will be used.   "
251348|NCT01146093|"     This is a single Dose Two-Way Crossover Fed Bioequivalence Study of Pravastatin 80 mg Tablets     of Dr.Reddy's Laboratories Limited with Pravachol 80mg, Bristol Myers Squibb in Healthy     Volunteers.   "
251357|NCT01146210|"     This research study is studying identification of de novo Fanconi anemia in younger patients     with newly diagnosed acute myeloid leukemia. Studying samples of tissue from patients with     cancer in the laboratory may help doctors identify and learn more about biomarkers related to     Fanconi anemia in patients with acute myeloid leukemia.   "
251358|NCT01146223|"     This research study is studying biomarkers in patients with acute promyelocytic leukemia.     Studying samples of bone marrow from patients with cancer in the laboratory may help doctors     learn more about changes that occur in DNA and about biomarkers related to cancer.   "
251359|NCT01146236|"     The trial is a randomized, controlled trial. Adult patients undergoing orthopaedic surgical     procedures would be randomized to one of two groups for surgical wound closure, skin sutures     or skin staples. The primary outcome measures would be surgical site infection indicated by     the use of oral or intravenous antibiotics for suspected wound infection and/or re-operation     at the same site. Patients would be followed up as per their usual post-operative course for     a total of three months in the trauma and spine population and six months in the total joint     arthroplasty population. It is hypothesized that wounds closed with sutures and staples will     have similar infection rates as defined by the use of antibiotics or reoperation.   "
251360|NCT01146249|"     Among the components of postural control, sensorial integration is of crucial importance. The     most important sensorial inputs for postural maintenance are the vestibular system which     provides information regarding accelerations of the head in space (HORAK 1994), the     somatosensory system which provides proprioceptive information that are used to determine     changes in body position (INGLIS 1994) and the visual system which provides information for     self motion in the environment. The receptors and the integration channel of each sensorial     system have inner characteristics which lead to different performance of the different input     in regards to the task and the environmental context (FITZGERALD 1994). Most of time,     sensorial information are congruent but sometimes they are conflicted. This is the case when     being in a stationary train, the train beside going on, giving the illusory sensation of     movement even if the vestibular system is not activated. A sensory weighting process is then     necessary for subjects to control balance. The Central Nervous System (CNS) is thought to     adjust the relative contribution of sensory input to control stance depending on     environmental conditions (CENCIANNI 2006) and the reliability of the sensory input (OIE 2002,     KESHNER 2004) in order to maintain or achieve the desired orientation in space and to provide     postural stability. Nevertheless the interconnection of the multiple sensorial feedback     involved in the postural control is not yet completely understood (CHIARI 2000).      Today, there is no tool available to evaluate the individual use of the sensorial information     to postural control. It seems interesting to have such a tool to better understand the     sensorial preference of subjects. It would be of particular importance for patients with     various pathologies in the aim to design individualized balance rehabilitation programs.      The aim of the study was to test a tool built to evaluate the sensorial preference of     subjects by studying their postural reaction related to the 3 main sensorial perturbations.     Normal subjects will be first tested to assess the repeatability of the protocol and to     collect normal values. Then, patients with post stroke hemiplegia, vestibular disease,     neuropathy and fallers will be studied in order to test the feasibility of the protocol and     to have preliminary data of sensorial preference among these populations.   "
251361|NCT01146262|"     Dendritic cells vaccinations are increasingly used in order to develop antitumoral immune     response. This will be a Phase 2 trial using autologous dendritic cells pulsed with leukemic     apoptotic corpse in acute myelogenous leukemia (AML) patients in first or second Complete     remission (CR).   "
251362|NCT01146275|"     Several subjects included in a Pilot study (CTN 31GB0106) during 2002-2003 still had     Macrolane deposits in the breast when the last study visit was performed. An additional     follow up visit is planned to follow duration and safety of the former formulation of     Macrolane that was used in the Pilot study (CTN 31GB0106).   "
251363|NCT01146288|"     Background:      Obesity is associated with a high prevalence of chronic kidney disease.The glomerular     hyperfiltration associated with obesity may play a role in the pathogenesis of obesity     associated chronic kidney disease. Attenuation of hyperfiltration by pharmacological means     may slow down the development and progression of chronic renal failure. The investigators     have previously shown that acetazolamide, a proximally acting diuretic that activates     tubuloglomerular feedback(TGF) by increasing solute delivery to the Macula DENSA, abates     glomerular hyperfiltration. The present study was designed to test the hypothesis that this     decrease in hyperfiltration is specific to acetazolamide and not due to a non specific     diuretic effect. The aim of the present study is to compare the effects of furosemide and     acetazolamide on glomerular hemodynamics in subjects with severe obesity.      Methods:      A randomized double-blind crossover controlled design will be used. Fifteen obese subjects     and ten subjects with normal body weight will participate in the study. Obese subjects will     undergo measurement of glomerular filtration rate (GFR)(inulin clearance), renal plasma flow     (RPF) (p-aminohippuric acid clearance), filtration fraction, fractional excretion of lithium     (FE LI) and blood pressure, before and after intravenous administration of furosemide 2 mg.     and acetazolamide 5 mg/kg BW. Ten subjects with normal body weight will undergo measurement     of renal function without administration of diuretics.   "
251379|NCT01146496|"     A major global public health priority is to identify effective methods for preventing deaths     from pesticide self-poisoning. The aim of this work is to determine whether the provision of     lockable storage containers to poor households in rural Asia can reduce the incidence of     intentional pesticide self-poisoning. Secondary questions include the effect of these     containers on unintentional pesticide poisoning in children and overall self-harm.   "
251380|NCT01146509|"     The purpose of this extension study was to evaluate the safety and efficacy of donepezil     hydrochloride after extended use in migraine prophylaxis. Efficacy will continue to be     evaluated.   "
251364|NCT01146301|"     As with coronary artery stenting, activation and embolisation of platelets occurs with     carotid artery stenting (CAS). Based on promising data on the use of clopidogrel plus aspirin     in coronary stenting this dual antiplatelet regimen has been introduced as adjunctive     treatment during CAS. There is as yet, however, no randomized controlled trial which compared     different loading doses of clopidogrel during CAS. Taking into account that a wide     interindividual variability in the response to a loading of clopidogrel exists, this study is     intended to establish the optimal loading dose of clopidogrel. Therefore platelet function     testing and a 1-hour of postprocedural TCD (transcranial doppler) monitoring will be     performed.      Objective: Firstly, to investigate whether the absolute magnitude of Platelet Inhibition     inversely correlates with the number of TCD-detected microemboli during and after CAS in     patients who are being pre-treated with either a 300 mg or a 600 mg loading dose of     clopidogrel. Secondly, if there is any impact on early neurological outcome determined by the     loading dose of clopidogrel.   "
251365|NCT01146314|"     The purpose of this study was to determine if a family-focused lifestyle intervention helps     to improve the health status, behaviors, and adjustment of overweight children.   "
251368|NCT01146353|"     Pharmacokinetics for peramivir have not been well characterized in patients undergoing     continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration     (CVVH) +/- dialysis (CVVHD). CRRT is commonly utilized in the hospital setting for patients     with acute kidney injury for metabolic correction, slow continuous fluid removal, and to     maintain hemodynamic stability. CRRT commonly alters drug disposition and clearance, and     dosing regimens often need alteration in patients receiving CRRT. Doses required to generate     predictable serum concentrations can be calculated from known patient parameters such as     replacement fluid and dialysate flow rate, sieving coefficients, and desired serum     concentrations. However, pharmacokinetic studies must be performed in CRRT patients to     generate drug removal constants or sieving coefficients. Of note, the clearance of drugs by     conventional hemodialysis cannot be used to extrapolate clearances with CRRT secondary to     differences in ultrafiltration rates and dialysis membranes. The investigators propose an     open label study to obtain peramivir pharmacokinetics in patients undergoing CRRT.   "
251369|NCT01146366|"     To prospectively look at the utility of routine cervical mediastinoscopy (lymph node biopsy)     in patients with clinically staged T2N0M0 NSCLC, as well as patients with clinically staged     T1N0M0 NSCLC with a high maxSUV of the primary tumor on PET imaging.      Hypothesis #1: The prevalence of mediastinal lymph node metastases detectable by cervical     mediastinoscopy is sufficiently low (<10%) to not support the routine use of this test in the     study population.      Hypothesis #2: The preoperative detection of occult(hidden) N2 lymph node metastases by     cervical mediastinoscopy in patients with clinically staged T2N0M0 NSCLC or T1N0M0 NSCLC with     maxSUV >10 on PET does not provide a survival benefit when compared to detection of occult N2     lymph node metastases at the time of thoracotomy using nodal dissection or systematic     sampling.   "
251370|NCT01146379|"     Arm weakness happens a lot after a stroke. People often get physical or occupational therapy     after their stroke to learn how to use their arm again. This study will help figure out how     much therapy should be given to restore as much arm function as possible.   "
251371|NCT01146392|"     The aim of this study is to describe COPD health care and to assess demographics, concurrent     diseases and mortality and the use of pharmaceuticals for a chronic obstructive pulmonary     disease (COPD) population in real life in primary care during the last ten years.   "
251372|NCT01146405|"     1. To investigate whether the auditory stimulation causes changes in hormones levels          (cortisol+prolactin) during general anesthesia.        2. To determine if there is a correlation between hormones levels (cortisol+prolactin) and          dreams recall.        3. To investigate whether, in patients receiving auditory stimulation, there is a          correlation between hormones levels (cortisol+prolactin), serum remifentanil          concentration and detection of implicit memory.        4. To investigate the presence of primary auditory cortex activation (temporal lobe) in          patients with implicit memory and in those with dreams recall using the EEG-ERP 128          channels GES300 EGI system.   "
251373|NCT01146418|"     The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after     the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single     injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle     stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled     ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm     injection (ICSI).   "
251374|NCT01146431|"     The purpose of this study is 1) to investigate whether the use of BIS as a guide to the     administration of inhaled anesthetic (sevoflurane or desflurane) compared with the use of     hemodynamic parameters (blood pressure and heart rate) would affect the occurrence of     implicit memory and /or dreams recall and 2) to check whether the occurrence of implicit     memory and/or dreams recall is related with MAC (Minimal Alveolar Concentration) of     inhalational anesthetics and/or preoperative anxiety levels.   "
251375|NCT01146444|"     Part I: to investigate the efficacy of different sunscreens in the prevention of skin lesions     following standardized photoprovocation with Ultraviolet A/Ultraviolet B (UVA/UVB) light in     patients with CLE.      Part II: to evaluate the influence of different sunscreens on the expression of biomarkers in     the skin of patients with CLE and of Healthy Controls following UV irradiation.   "
251376|NCT01146457|"     The purpose of this study is to determine the ideal dosage of intrathecal morphine for intra     and post partum analgesia, while minimizing the side effect profile.   "
251377|NCT01146470|"     The study hypothesis is that 3 Months Daily Supplementation of RGC will effect blood pressure     and vascular function.      This will be a single-center, double-blind, random, parallel controlled Study. Study     population will include 60 subjects, who will be divided randomly into three groups. The     first group will get RGC 200mg, the second group will get RGC 400mg, and the third group will     get 200mg placebo.   "
251383|NCT01146548|"     This is a French national trial, conducted using a double-blind, placebo-controlled,     randomised design involving 15 centers and 88 patients of both sexes.      The primary objective of the trial is to evaluate the effect of a selective inhibitor of     serotonin reuptake, the Fluoxétine, at a higher dose (40 mg/day) than usually recommended for     depressed patients, after three months in patients suffering from an atypical Parkinson's     disease called Multiple System Atrophy, compared to the placebo effect.      Secondary objectives of the trial are the evaluation of the effects of Fluoxétine after six     weeks at the dose of 20 mg/day, after six months at the dose of 40mg/day, and assess the     effects on mortality, quality of life, autonomic disorders, particularly orthostatic     hypotension, mood and others symptoms such as sleep, apathy, pain and fatigue.   "
251384|NCT01146561|"     Tanezumab is effective in reducing the pain associated with chronic pancreatitis.   "
251385|NCT01146574|"     This is the first study in hemodialysis subjects with anemia to evaluate the     pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept     (ACE-011)   "
251402|NCT01146678|"     Primary Objective:        -  to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and          lixisenatide given subcutaneously as on-site mix versus separate and simultaneous          injections of each drug      Secondary Objectives:        -  to compare the activity of a single dose of insulin glargine and lixisenatide given          subcutaneously as on-site mix versus separate and simultaneous injections of each drug        -  to assess the safety and tolerability of insulin glargine and lixisenatide given          subcutaneously as on-site mix   "
251403|NCT01146691|"     Intensive Care Units (ICU) are an important, but troubled, part of modern health care     systems. While it seems likely that both the technical and structural elements of ICU care     are important determinants of relevant ICU outcomes, little is known about how the structure     of ICU care affects outcomes. One element of potential importance is the way that ICU     physicians (intensivists) organize themselves to provide ICU care, particularly at night. The     dominant, historical (standard) model of intensivist staffing involves an intensivist who     is present during daytime hours, but then takes call at night from home. But, in recent     years there has been widespread concern about whether patients experience adverse events or     worse outcomes related to a lesser level of expertise and care readily available at night in     hospitals. Only two studies, both from single ICUs, and both using simple before vs. after     study designs, have conducted interventional studies directly comparing a standard     intensivist staffing model with a 24-7 model of nighttime intensivist coverage via shift     work, i.e. with the daytime intensivist giving way at the late afternoon to a nightshift     intensivist who remained in the hospital and covered the ICU until morning. Those two studies     found contradictory effects of the intervention. But despite the absence of clear data     indicating a benefit to ICU patients associated with having intensivists remain in the     hospital overnight, there has been a major movement around the world towards ICU staffing     models utilizing shift work to ensure such coverage. The potential impact of such a change in     staffing paradigm is large, with possible effects on all the other major stakeholders     involved in ICU care: families, nurses, and house officers. Both benefits and detriments are     possible.      On the one hand, moving to a shift work model from a model in which a single intensivist     becomes overworked and sleep-deprived as a result of being responsible for care both day and     night, has the potential to reduce the sleep deprivation, job distress, and burnout prevalent     among intensivists with standard staffing models. But, it would also require more     intensivists, a serious challenge given the worsening intensivist manpower shortage. Also,     there are many detrimental effects of shift work on humans, including negative effects on     motor function, cognition, sleep, job satisfaction, mood, errors, and cardiovascular health.     Shift work is the most common reason that Emergency Medicine physicians give for leaving that     field. The physical availability of an intensivist around-the-clock might also influence the     problems mentioned of family dissatisfaction with communication in ICUs, and poor     communication/ teamwork with physicians often perceived by ICU nurses. In ICUs of teaching     hospitals, where relatively inexperienced house officers typically remain in the ICU     overnight, the nighttime presence of an attending physician might influence residents'     perceptions of domains such as teaching, and clinical autonomy.      This purpose of this study is to rigorously compare the effects of two different intensivist     staffing models, specifically the current standard model, and a 24-7 staffing model enabled     via shift work. This study will be conducted in two ICUs, one academic with house officers     who remain in ICU overnight (the Medical ICU at Health Sciences Center), and one in a     community hospital which currently lacks overnight, in-ICU physicians (the Victoria General     Hospital).      This study is designed to improve upon both prior studies. To obviate the problems with using     historical controls inherent in those before-vs-after study designs, our study will alternate     the two staffing models (e.g. A-B-A-B). Also, the investigators will rigorously assess the     effect of 24 hour intensivist presence on all major stakeholders, i.e. patients, families,     intensivists, nurses, and house officers.   "
251386|NCT01146587|"     The GangTrainer GT I and the Lokomat have proven their effectiveness on stroke Patients, but     a comparison on the same controlled study population has not been made so far. Aim of the     study will not only be to establish which device will work better on acute, non ambulatory     stroke Patients in terms of regain of gait ability and motor function, but also clinical     matters, like the efficacy of the treatment period. As a result of the trial it should be     highlighted which kind of therapy has to be suggested for Patients comparable to the study     population. A significant better outcome of one device in regard to the other will suggest to     use one device more than the other for future treatments.   "
251387|NCT01146600|"     The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness     and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is     caused by a problem with the quality of sleep occurring at night, for instance when nighttime     sleep is disrupted by frequent breathing pauses. In other cases, however, hypersomnia occurs     even when nighttime sleep is of good quality. These cases of hypersomnia are presumed to be a     symptom of brain dysfunction, and so are referred to as hypersomnias of central (i.e., brain)     origin.      The causes of most of these central hypersomnias are not known. However, our group has     recently identified a problem with the major brain chemical responsible for sedation, known     as GABA. In a subset of our hypersomnia patients, there is a naturally-occurring substance     that causes the GABA receptor to be hyperactive. In essence, it is as though these patients     are chronically medicated with Valium (or Xanax or alcohol, all substances that act through     the GABA system), even though they do not take these medications.      Current treatment of central hypersomnias is limited. For the fraction of cases with     narcolepsy, there are FDA-approved, available treatments. However, for the remainder of     patients, there are no treatments approved by the FDA. They are usually treated with     medications approved for narcolepsy, but sleep experts agree that these medications are often     not effective for this group of patients.      Based on our understanding of the GABA abnormality in these patients, we evaluated whether     clarithromycin (an antibiotic approved by the FDA for the treatment of infections) would     reverse the GABA abnormality. In a test tube model of this disease, clarithromycin does in     fact return the function of the GABA system to normal. The investigators have treated a few     patients with clarithromycin and most have felt that their hypersomnia symptoms improved with     this treatment.      To determine whether clarithromycin is truly beneficial for central hypersomnia, this study     will compare clarithromycin to an inactive pill (the placebo). All subjects will receive both     clarithromycin and the placebo at different times, and their reaction times and symptoms will     be compared on these two treatments to determine if one is superior. If this study shows that     clarithromycin is more effective than placebo in the treatment of hypersomnia, it will     identify a potential new therapy for this difficult-to-treat disorder.   "
251388|NCT01146613|"     The primary objective of this study is to assess the efficacy of varenicline in reducing the     proportion of heavy drinking days during the last 8 weeks of treatment in subjects with     alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text     Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day     for men and 8 or more drinks for women (designated as very heavy drinkers).   "
251389|NCT01146626|"     Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy     obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3.     Studies rarely address the issues of improving host factors. The current study examines        1. whether adding vitamin D, a potent immunomodulator, could improve viral response and          shorten treatment duration (from 24 weeks to 12 weeks)        2. whether Vitamin D levels predictes negative treatment outcome.   "
251390|NCT01140321|"     An Italian Multicentric randomized, open-label therapeutic trial evaluating the efficacy and     safety of Neridronate in the treatment of Osteoporosis in patients with Thalassemia Major and     Severe Thalassemia Intermedia.      Efficacy and safety of the drug will be evaluated measuring at every visit this parameters:        -  haematological: Haemochrome        -  blood chemistry: creatinine, BUN, AST, ALT, Ca, P, proteins electrophoresis, total          proteins.      The prevalence of ectopic calcification and pseudoxantoma elasticum (PXE)-like syndrome and     their follow-up will be evaluated at the beginning of the study vs 24 months through physical     examination, abdominal echography and fundus oculi examination.      During the trial other known risks factors for osteoporosis will be recorded, including     prevalence and incidence of bone fractures and, if executed, Polimorphisms COLIA1.      At the beginning of the study and at months 12 and 24 morphometry DXA will be performed to     evaluate of the presence of bone deformities.      Furthermore data regarding QOL and symptom pain will be evaluated trough administration of     scale SF-36.      At 12 months an intratrial analisis will be performed on efficacy and safety parameters in     order to introduce possible amendments to the study design and to decide the prosecution of     the trial      During the trial all adverse events will be recorded   "
251391|NCT01140334|"     The purpose of the study is to evaluate methods to help people in substance abuse treatment     receive better psychiatric care. Patients enrolled in the study will be offered three months     of standard psychiatric treatment, which consists of weekly individual counseling and group     counseling, as well as regular appointments with a psychiatrist. Patients will be randomly     assigned to standard psychiatric care or standard psychiatric care plus voucher incentives.     These incentives can be earned by successfully attending all scheduled psychiatric     appointments each week. The investigators expect that patients in the voucher condition will     attend more psychiatric sessions, which will lead to greater reductions in psychiatric     distress.   "
251413|NCT01146821|"     The primary objective of this trial is to determine the safety and efficacy of IV fish oil     doses of 0.20 g/kg and 0.50 g/kg, compared to a control group, in critically ill patients     with severe sepsis by examining organ function, blood safety and biochemical parameters,     markers of systemic inflammation and innate immunological parameters   "
251527|NCT01148472|"     The primary objective of this study was to compare the efficacy of escitalopram with that of     duloxetine in outpatients with Major Depressive Disorder (MDD) after 24 weeks of treatment.     The study hypothesis was that there were clinically important differences between the two     drugs in terms of efficacy and adverse event profiles.   "
251392|NCT01140347|"     This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of     ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison.      Approximately 544 participants, at least 18 years of age, with Child-Pugh score < 7 and     diagnosed with hepatocellular carcinoma will be randomized. Participants must have received     sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have     discontinued sorafenib prior to entering the study.      Hypothesis: This sample size will allow differentiation of the expected increase in median     overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab     arm.      Upon registration and completion of screening procedures, eligible participants with HCC who     have disease progression during or following first-line therapy with sorafenib, or were     intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo.      The treatment regimen will be continued until radiographic or symptomatic progression, the     development of unacceptable toxicity, noncompliance or withdrawal of consent by the     participant, or investigator decision.   "
251393|NCT01140360|"     This is a second Pilot Study to determine the efficacy of Gleevec® in neurofibromatosis (NF1)     patients with plexiform neurofibromas using new response assessment modalities with the     secondary goals of assessing Gleevec toxicity, and characterizing markers of response. The     rationale for this study arises from the response of human and murine NF1 cells to Gleevec®     in vitro, the response of a NF1 patient treated with Gleevec® for airway compression by a     plexiform neurofibroma with a dramatic response not previously seen in NF1 therapy, and the     experience in 37 NF1 patients treated with Gleevec® in the initial pilot study. Gleevec will     be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2     or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the     dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum     dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of     55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid. Treatment     will continue for 6 months with an option to continue for 24 months if the patient is     deriving a clinical benefit.   "
251394|NCT01140373|"     This is a phase I study which will test the safety of different doses of the patients own     immune cells which have been changed to help recognize and destroy the cancer cells. The     investigators want to find out what effects, good and/or bad, it has on the body and on the     prostate cancer. The immune cells (T cells) used in this study will be the patients own     immune cells. They will be removed from the patients blood, changed in the laboratory, and     then put back into their body. T cells help the body fight infections. These cells may also     kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer     cells. For this reason, the physician will change the T cells by putting in a gene so that     they may be able to better recognize and kill the prostate cancer cells. A gene is a portion     of information which comes from the DNA and tells the cell what to do. This gene will be put     into the patients T cells by a weakened virus. It is hoped that this approach will help the T     cells recognize the prostate cancer tumor cells and possibly kill them. The investigators     have found that T cells modified in this way were able to cure a cancer similar to Chronic     Lymphocytic Leukemia in mice. However, this is an entirely new treatment for prostate cancer     and it is not known if it will have any beneficial or unexpected harmful effects.   "
251395|NCT01140386|"     The issue to be studied is the prevalence of venous thromboembolism (VTE) in hospitalized     pediatric patients, and to identify if there are subgroups of patients who may be at higher     risk.      There are two hypotheses that will be looked at in this study. The first hypothesis is that     individual risk factors for VTE in hospitalized pediatric patients are: age >14, obesity,     black race, female sex, presence of a central venous line (CVL), traumatic mechanism of     injury, orthopaedic surgery, and use of oral contraceptives.      The second hypothesis is that risk factors have an additive effect such that risk     stratification can be developed to identify those patients with the highest risk.   "
251396|NCT01140399|"     The purpose of this study is to determine whether in patients with acute decompensated     congestive heart failure and the cardiorenal syndrome, i.e. a state in which therapy directed     to improve symptoms is limited by further worsening renal function, fluid removal by     ultrafiltration is superior to different pharmacological approaches in acutely relieving     congestion and preventing further deterioration in renal function and whether it results in     longer admission-free survival 90 days after enrolment   "
251397|NCT01140412|"     This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of     14 healthy male and/or female subjects, to estimate the effect of maraviroc on the     pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the     pharmacokinetics of maraviroc.   "
251398|NCT01140425|"     The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A     prolonged QT interval is a risk factor for arrhythmias.   "
251399|NCT01146639|"     Endovascular therapy of Aortic Aneurysms depends on good imaging facilities. A relatively new     kind of x-ray equipment makes it possible to create computer tomography (CT) - like slice     images in the operating room. The purpose of this study is to verify the clinical usefulness     of DynaCT in a preoperative setting. To do so we compare aortic measurements in DynaCT to the     same measurements in ordinary CT-images which are regarded the gold standard.   "
251400|NCT01146652|"     Primary Objective:      Assess the long term safety of sarilumab in patients with rheumatoid arthritis.      Secondary Objective:      Assess the long term efficacy of sarilumab in patients with rheumatoid arthritis.   "
251414|NCT01146834|"     This phase III randomized trial compares three different peripheral stem cell mobilization     regimens for patients with multiple myeloma who have received primary induction therapy or     other therapies. Up to 180 patients will be enrolled. Patients eligible for treatment will be     randomized to one of the three following mobilization regimens:      Arm A = VELCADE, CYCLOPHOSPHAMIDE, G-CSF Arm B = VELCADE & G-CSF Arm C = CYCLOPHOSPHAMIDE &     G-CSF   "
251476|NCT01147796|"     Transoesophageal echocardiography (TEE) is considered as the gold standard method for     detection of left atrial appendage (LAA) thrombus but is a semi-invasive investigation. The     primary aim of the study is to evaluate the accuracy of the 64 slices CT using prospective     gating for the diagnosis LAA thrombus. The secondary objective is to defined the optimal     acquisition time offering the best diagnostic performance (early, late or both).   "
251401|NCT01146665|"     Alcohol misuse amongst youth is a significant clinical and public health problem. The     Emergency Department (ED) is an important setting for the treatment of alcohol-related     problems as it is often the first point of contact between youth, their families, and the     healthcare system. This pilot study will assess the feasibility and acceptability of a     computer-based intervention in the ED for youth with alcohol-related presentations. The     investigators research team will: (1) evaluate the methodological and operational processes     involved in study recruitment and intervention implementation, (2) determine recruitment and     retention rates, and (3) obtain preliminary data on the difference in alcohol consumption at     different time points. The clinical and health service implications of this research will be     used to plan further investigations designed to improve the standard of ED care among youth     aged 12 to 16 with alcohol-related presentations. This research will also help optimize the     planning and development of a full-scale randomized controlled clinical trial of a     computer-based intervention designed to reduce higher-risk alcohol consumption and     alcohol-related health and social problems in this target population.   "
251404|NCT01146704|"     The objective of this study is to test and determine whether a high protein diet is     efficacious, safe and beneficial to curtail food intake and body weight in obese adult human     patients and to establish whether neurohormonal mechanisms of a high protein diet induce an     early signal of fullness or satiety in a relevant experimental model, focusing on activation     of gastric vagal afferents.   "
251405|NCT01146717|"     This study is being done to find out whether regulation of brain blood flow is altered in     patents with mild cognitive impairment (those who have memory problems but otherwise healthy)     when compared with healthy elderly individuals. In addition, this study will determine     whether exercise training improves brain blood flow, brain structure, and brain function in     patients with mild cognitive impairment (MCI).      This is a research study because at present the investigators know little about brain blood     flow regulation in patients with mild cognitive impairment. The investigators also know     little about whether exercise training improves brain blood flow, brain structure, and brain     function in patients with mild cognitive impairment.   "
251406|NCT01146730|"     Mental disorders, mainly various anxiety and depressive disorders, are an increasing reason     for sick leave and disability pension. Cognitive behaviour therapy (CBT) has been shown to     have an effect on anxiety and depression, but the investigators know little about this in     relation to employment. Close follow-up in ordinary employment increase employment     participation for serious mental illness, but this is not yet investigated to the same degree     for lighter mental disorders.      Center for Work-Coping (No: Senter for Jobbmestring - SJM) combines Cognitive behaviour     therapy (CBT) and individual placement and support (IPS) and facilitation of work for people     with anxiety and depression who are in danger of falling out of work.      The purpose of this project is to evaluate the effectiveness of the model in SJM. The effect     will be evaluated through a randomized controlled trial (RCT) in which participants will be     randomized to SJM or regular follow-up by The Norwegian Labour and Welfare Administration     (NAV) or by their regular general practitioners (GP) and self-help resources. The main     outcome measures are work participation with changes in mental health as a secondary outcome.   "
251407|NCT01146743|"     The investigators would like to conduct a prospective, randomized non-inferiority study to     compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and     percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis     patients.   "
251408|NCT01146756|"     Two thirds of non small cell lung cancer patients present with locally advanced tumours     (stage III) or metastatic disease (stage IV) and radiotherapy plays a major role in their     treatment. Treatment (radiotherapy and chemotherapy) can be given with curative intent to     selected patients with locally advanced, stage III disease. Patients with stage III tumours     associated with a pleural effusion, and patients who present with advanced, metastatic     disease (stage IV) are treated palliatively with no prospect of cure. In the latter,     radiotherapy (RT) is offered with the aim of improving symptoms, achieving tumour control and     optimising quality of life. It is generally believed that a plateau has been reached for     combination of chemotherapy with radiotherapy lung cancer. There is a strong rationale for     combining molecular targeted agents with irradiation. AZD6244 is a potent, selective,     uncompetitive inhibitor of MEK that has been tested in early phase clinical trials either     alone or in combination with chemotherapy in a variety of cancers including lung cancer.     Preclinical studies have shown that AZD6244 enhances the effect of radiation. AZD6244 has not     yet been combined with radiotherapy in clinical trials. In this study, a maximum of 18     patients will be allocated to one of 3 doses of AZD6244 in combination with a standard dose     of RT in a Phase 1 dose escalation/ de-escalation design to determine the recommended dose     for Phase 2 trials (RP2D). An expanded cohort of 15 patients will be treated at the RP2D to     obtain additional safety and preliminary response data. Patients will undergo 3 FLT positron     emission tomogram (PET) scans, the first scan before treatment, second scan during AZD6244     treatment and third scan during RT. All patients will also have tissue/blood samples     collected for biomarkers. Biomarkers and FLTPET imaging will be examined to obtain     information that may predict for response, resistance or toxicity to radiation and AZD6244.   "
251409|NCT01146769|"     The aim of study is to investigate the difference in Maximum Squeeze Pressure in patients     with and without pelvic floor muscle training in low anterior resection in peri-operative     period   "
251410|NCT01146782|"     This is a prospective study of the Attune Sleep Apnea System for the treatment of obstructive     sleep apnea. The objective of the study is to demonstrate safety and effectiveness of the     Attune Sleep Apnea System to support FDA marketing clearance of the device.   "
251411|NCT01146795|"     This study is to determine the feasibility of administering neoadjuvant carboplatin,     paclitaxel, and bevacizumab without excessive dose modification or cycle delay in patients     with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.   "
251412|NCT01146808|"     The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing     de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts     but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B     naive patients). The second objective is to evaluate the efficacy of accelerated vaccination     with Hepatitis B in inducing innate immunity, thereby obviating the need for life-long     antiviral therapy.   "
251415|NCT01146847|"     Hyperglycemia is common in critically ill patients and associated with an adverse outcome.     Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of     the intensive care unit staff difficulties were experienced in achieving efficient and safe     glucose control. A fully automated algorithm may help to overcome some of these limitations     by excluding intuitive interventions and integrating relevant clinical data in the     decision-making process. Space GlucoseControl (TGC system) is a decision support system which     helps to achieve safe and reliable blood glucose control in the desired ranges. Information     on parenteral and enteral nutrition is automatically integrated into the calculations. The     primary objective of the current study is to investigate the performance and usability of the     Space TGC system for glucose control over an tight glucose control range (4.4 to 6.1 mmol/L)     in surgical intensive care patients.   "
251416|NCT01146860|"     The purpose of this study is to determine whether the dry extract BNO 1016 is effective and     safe in the treatment of acute rhinosinusitis in adults.   "
251445|NCT01147393|"     A Phase I/II clinical trial using a fractionated dosing regimen of 90Y-epratuzumab     (anti-CD22) has showed encouraging responses in follicular and aggressive NHL with an ability     to administer safely 2 injections of 20 mCi/m2 spaced 1 week apart. The investigators propose     to combine this active 90Y-epratuzumab treatment with a regimen of veltuzumab that was also     found active in Phase I/II trials.      The goal of this study is to determine the safety and efficacy of 90Y-epratuzumab when used     in combination with veltuzumab. The primary objective is to determine the response rate of     this combination treatment. Secondary objectives are to assess safety, pharmacokinetics and     targeting of 90Y-epratuzumab . Veltuzumab blood levels and anti-antibody responses will also     be monitored at various times.   "
251417|NCT01146873|"     The investigators hypothesize that switching to a regimen based on efavirenz will be as     effective and safe as remaining on a regimen based on Lopinavir/ritonavir for HIV-infected     children.      The investigators propose an unblinded randomized clinical trial to evaluate a     simplification, protease-inhibitor (PI)-sparing treatment strategy among nevirapine     (NVP)-exposed HIV-infected children treated initially with lopinavir/ritonavir (LPV/r).     HIV-infected children aged 3-5 years, who have a history of exposure to NVP as part of     prevention of mother-to-child HIV transmission (PMTCT), initiated LPV/r-based therapy in the     first 36 months of life or who were enrolled on the control arm of Neverest 2 and who are     virally suppressed with a viral load < 50 copies/ml will be included. These children will be     randomized to either substitute efavirenz (EFV) for LPV/r or to continue on their LPV/r-based     regimen. Eight weeks prior to the primary randomization, eligible children will also be     randomized to either remain on stavudine (D4T) or switch to abacavir (ABC). Children will be     followed with regular viral load and other clinical tests for 48 weeks after the primary     randomization. Children in the experimental arm who have breakthrough viremia (-defined as     two subsequent viral loads > 1000 copies/ml) on the EFV-based regimen will reinitiate the     LPV/r regimen. The primary objective is to test whether the durability of viral suppression     is equivalent when children are switched to EFV-based therapy. The primary study endpoint is     failure to have HIV RNA < 50 copies/ml and/or confirmed viremia >1000 copies/ml. Secondary     aims include comparison of immune preservation, toxicities, selection of resistance     mutations, and adherence across the two arms. Antiretroviral drug concentrations and     adherence will be investigated as possible explanations for the success and/or failure of     this simplification regimen. The overall goal of the study is to contribute to the evidence     base to allow expansion of treatment options for HIV-infected children in low resource     settings.   "
251418|NCT01146886|"     The purpose of the study is to investigate the safety, tolerability, pharmacokinetics incl.     dose proportionality, and pharmacodynamics of BI 135585 XX (Part 1), as well as the relative     bioavailability of two different immediate release tablet formulations versus oral solution     (Part 2)   "
251419|NCT01146899|"     Childhood influenza coverage rates are far below rates for the other childhood vaccinations.     Increasing influenza vaccine coverage rates is important not only for the health of the     child, but for that of the child's household and community. Yet,influenza vaccine delivery     rates at pediatric clinics are low, even when the vaccine is available. The proposed project     will take advantage of existing health information technology to tailor, implement and     evaluate influenza vaccine alerts in the electronic health record (EHR) for pediatric     providers to help improve health care decision making.   "
251420|NCT01146912|"     The Advisory Committee on Immunization Practices (ACIP)recommends that the flu vaccine be     administered annually to all children aged 6 months to 18 years as well as women who are     pregnant during the influenza season. Nevertheless, targeting and mobilizing these     populations has been difficult and influenza immunization rates nationwide remain low.     Immunization reminder-recalls have been shown to be effective, but have had limited ability     to rapidly identify and reach large target populations in a cost-effective manner. Evidence     on how to optimally design these systems is not yet available and thus text message     immunization alerts have not been widely implemented. The investigators propose to implement     and evaluate tailored, targeted influenza text message reminders in urban pediatric and     pregnant populations.   "
251421|NCT01146925|"     The primary objective of this trial is to assess the impact of CRMD-001 on markers of     contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease     (CKD) undergoing coronary angiography and PCI.   "
251422|NCT01146938|"     To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in     hepatic impairment patients and healthy volunteers   "
251423|NCT01146951|"     To confirm that the combination therapy of rufinamide has superior efficacy compared to     placebo in patients with Lennox-Gastaut syndrome.   "
251424|NCT01146964|"     The purpose of this study is to compare the safety and efficacy of manual super small     incision cataract surgery (MSSICS) and Phacoemulsification.   "
251425|NCT01147133|"     Clopidogrel is essential for the prevention of vascular events in patients after percutaneous     coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from     the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the     original formulation of clopidogrel-bisulphate. However, as the patency of Plavix® has     expired in November 2009 in Hungary, several generic clopidogrel have been introduced to the     market. Some of the generics are using the original bisulphate formulation, while others are     with besylate salt of clopidogrel. Despite the differences in the clopidogrel-salts, the     different carriers might also modulate the pharmacokinetic/pharmacodynamic profile of each     drug. As the consequences of the impaired antiplatelet potency might be devastating,     including stent thrombosis, the investigators sought to compare generic clopidogrel to the     original blister by different assays of platelet aggregation.   "
251426|NCT01147146|"     The effects of anesthetic method on cerebral oxygen saturation in geriatric patients     undergoing transurethral surgery.   "
251442|NCT01147354|"     The aim of this study is to evaluate the effect of selenium supplementation on oxidative,     inflammatory and nutritional markers in hemodialysis patients.   "
251443|NCT01147367|"     The purpose of the study is to examine the benefits of physical activity for breast cancer     survivors related to muscle strength, tiredness, and sleep quality. Also, the study will     determine the potential role of inflammation in these benefits.   "
251444|NCT01147380|"     The objective of this study is to evaluate feasibility and safety of the adoptive transfer of     activated natural killer (NK) cells extracted from cadaveric donor liver graft perfusate for     liver transplant recipients with hepatocellular carcinoma (HCC)   "
251779|NCT01152554|"     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like     medicine tablet or capsule, but contains no active medicine) is safe and effective when taken     for 52 weeks with another antidepressant medicine.   "
251446|NCT01147406|"     The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy     subjects.   "
251447|NCT01147419|"     Different strategies exist in the treatment of chronic long occlusion of the superficial     femoral artery. Traditionally, these patients should be treated with bypass. If the great     saphenous vein is unavailable, doctor has to choose artificial vessel as graft. Now, the     skill of endovascular treatment is developing rapidly, and lots of doctors think most of such     patients could be treated with stent. The purpose of this trial is to compare stent and     artificial blood vessel bypass in the treatment of long occlusion of the superficial femoral     artery. The study hypothesis is that patency rates are comparable and therefore the minimal     invasive treatment of stent can be considered in such patients.   "
251516|NCT01148329|"     The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-     Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™     Element™ Coronary Stent System in unselected patients in routine clinical practice.   "
251427|NCT01147159|"     Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic     and non-allergenic components. Many factors such as the biovariability, differences in     extraction process and subsequent handling of allergens can affect the final composition,     potency, and stability of allergen preparations. Genetic diversity of affected people adds     another level of complexity. In order to control variability and to achieve consistency and     reproducibility for optimal safety and sensitivity/specificity, it is essential to     standardize the amount of allergen used in prick tests. Therefore, the system for biological     standardization mainly used in Europe still is the biological calibration of in-House     Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines     as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT)     value. The aim of this procedure is to estimate the biological activity of allergen extracts.     The activity of an allergen extract is defined as 10,000 Diagnostic Biological Units (DBU)     per ml (1 SPT per ml), when the extract provokes a specific skin reaction with a wheal of the     same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when     both solutions are administrated using the same technique (prick testing) on at least 20     individuals who are clinically allergic and cutaneously reactive to the allergen concerned.      The present study aims to standardize the allergen extracts of Betula pendula, Phleum     pratense and Dermatophagoides pteronyssinus by using this method.        -  Trial with medicinal product   "
251428|NCT01147172|"     Elevess is intended for all skin types. However, further study of all soft tissue fillers is     needed in people of color because of the increasing use of cosmetic dermal filler products.      This study is designed to evaluate the safety of an injectable hyaluronic acid based dermal     filler Elevess (Anika Therapeutics, Inc., Bedford, MA). Safety will be evaluated by incidence     and severity of keloid formation and pigmentation changes, and other potential adverse events     in people with Fitzpatrick skin types IV, V and VI who have elected to undergo nasolabial     fold (NLF) treatment with Elevess.      1. Fitzpatrick Classification of Skin Type as: IV - Burns minimally, always tans well     (moderate/light brown skin; Mediterranean, Asian, Hispanic. V - Rarely burns, tans profusely     (dark brown/brown skin: Middle eastern, Latin, light skinned Black, Indian) VI - Never burns,     (deeply pigmented dark brown to black skin;Black)   "
251429|NCT01147185|"     The purpose of this study is to determine whether longer locomotor training results in a mor     favorable outcome in patients with incomplete spinal cord injury.   "
251430|NCT01147198|"     Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe     malnutrition. Their efficacy and effectiveness were proven in community therapeutic care     programs. Recently, the question rose if RUTF would be more effective than enriched flours to     treat moderate malnutrition.      The purpose of this study is to compare the effectiveness of Ready to Use Food     Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain,     duration of treatment, morbidity and mortality in the treatment of moderate acute     malnutrition.      Compare the longer term effect on nutritional status and morbidity (relapse?).   "
251431|NCT01147211|"     This is a phase I study of MK2206 (an AKT inhibitor)and gefitinib in nonsmall cell lung     cancer patients who failed prior chemotherapy and epidermal growth factor receptor-tyrosine     kinase inhibitor (EGFR-TKI). The patient population is enriched for EGFR mutations.      The purpose of this study is to determine whether it is safe to administered MK-2206 in     combination with gefitinib in adult patients with locally advanced or metastatic non-small     cell lung cancer. The second purpose of this study is to define the MTD (Maximum Tolerated     Dose) of MK-2206 when combined with gefitinib.      A standard 3-3 dose escalation scheme of MK-2206 with fix dose gefitinib is used in this     study.   "
251432|NCT01147224|"     The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent     asthma including or excluding allergic components over 3 months, especially in the spring     season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further     data on safety and tolerability of Alvesco .   "
251433|NCT01147237|"     The utilization of everolimus-eluting coronary stents in a coronary artery diseases is     effective in reducing both repeat revascularization and major adverse cardiac events within     two year follow-up. To evaluate the procedural, short and long term clinical outcomes of     multiple everolimus-eluting coronary stent implantation in long (>30mm) coronary lesions.   "
251434|NCT01147250|"     Primary Objective:      - To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality     (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke,     hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who     recently experienced an acute coronary syndrome (ACS) event.      Secondary Objectives:      To demonstrate that when compared to placebo, lixisenatide can reduce:        -  composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for          unstable angina, or hospitalization for heart failure.        -  composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for          unstable angina, hospitalization for heart failure, or coronary revascularization          procedure.        -  urinary albumin excretion (based on the urinary albumin/creatinine ratio).      To assess the safety and tolerability of lixisenatide.   "
251435|NCT01147263|"     Clinically Characterized by the presence of chronic widespread pan and tenderness,     Fibromyalgia (FM) is one of the most common functional syndromes. FM is currently conceived     of as representing a prototype of central pain, i.e. a condition in which sensitization of     the central nervous system results in a overall increase in the processing of painful     stimuli, as well as an impairment of pain inhibition. This condition is responsible for     significant a social and economic burden and is estimated to affect up to 5% of all women.     The 1990 American College of Rheumatology (ACR) classification criteria for FM are the     current standard for studying FM, and require the presence of widespread pain lasting over 3     months, as well as documentation of tenderness in at least 11 of 18 pre-defined tender     points. Multiple additional symptoms, which are not part of the classification criteria,     include among others sleep disturbances, mood disturbances, cognitive dysfunction,     vulvodynia, dysmenorrhea, sexual dysfunction and weight fluctuations. In addition, FM is well     known to overlap both clinically and epidemiologically with an ever increasing number of     other functional disorders, including irritable bowel syndrome (IBS), Temporomandibular     joint disorder (TMJD), functional dyspepsia etc. In addition to the central symptom of pain,     FM patients frequently complain of non- specific symptoms which are potentially autonomically     - mediated. Thus, palpitations, fatigue and inability to stand for long periods of time are     all common complaints. About 80-90 percent of FM patients have one or more symptoms     associated with autonomic dysfunction. The most common of them is presyncope (62.5%),     followed by syncope (12.5%), palpitations on standing (12.5%) and dizziness (12.5%) (14).     Some of these symptoms overlap with those of the postural tachycardia syndrome (POTS). POTS     is a common dysautonomia, characterized by remarkable increased heart rate during the     assumption of the upright posture (>30 bpm). According to our experience, FM is found, at     least, in 15% of POTS patients. But, no data exists about the incidence of POTS in patients     with FM.The role of the autonomic nervous system (ANS) in initiating and maintaining the     syndrome of FM has been studies (and debated) over the last decade. The ANS is an extremely     complex system, regulating involuntary body functions, including heart rate, intestinal     motility, urination, and sexual activity, among many other variables. Notably, the vagus has     an inhibitory effect on pain. Deterioration in the vagal control is associated with     increased pain sensation. Previous studies have indicated that FM patients may have an     increase in sympathetic control over the cardiovascular system with a reciprocal decrease in     parasympathetic control. High sympathetic tone is usually associated with a lower threshold     to pain. But, the contribution of the ANS to the pathogenesis of FM syndrome remains unclear.     Evidently, the ANS interacts with other components of the CNS in the pathogenesis of FM,     including pain processing centers in the thalamus and amygdala, as well as with the     hypothalamic-pituitary-adrenal (HPA) axis.   "
251436|NCT01147276|"     The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon     counterregulatory response to hypoglycemia in type 1 diabetes.   "
251437|NCT01147289|"     A phase III, randomized, multicenter, open label clinical trial to evaluate efficacy and     safety of the injectable association of dexamethasone, dipyrone, and hydroxocobalamin in     lumbar sciatic pain. The study will enroll 140 patients in each arm (280 total).   "
251438|NCT01147302|"     The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1     Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated     Rejection (AMR).   "
251439|NCT01147315|"     The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.   "
251440|NCT01147328|"     The purpose of this study is to assess usage of the virtual health record (VHR), and     determine the effects of this technology on healthcare utilization.   "
251441|NCT01147341|"     Purpose of the study is to determine if Cimzia is safe and effective in subjects who have     received previous treatment with a TNF-alpha inhibitor other than Cimzia.   "
251448|NCT01147432|"     Prior to administering PF-04427429 to patients we wish to increase the understanding of     functional effects associated with calcitonin gene related peptide (CGRP) pathways. This     study will examine whether it is possible for a single dose of PF-04427429 to acutely     attenuate a capsaicin induced flare response.   "
251449|NCT01147445|"     The purpose of this study is to learn if a new candidate vaccine (dmLT) against ETEC (E. coli     infection) is safe. This vaccine will be tested to see what effects it has on the body and     the ability of the vaccine to help the body resist disease. Researchers want to find the     highest dose of dmLT vaccine that can be given without causing severe side effects. Most E.     coli bacteria are harmless to humans and can even be beneficial. However, some are harmful,     and can cause diarrhea. About 32 healthy adults, ages 18-45, will participate in this study.     This study will require volunteers to stay in the research facility for several nights.     Participants will be assigned to receive 1 of 4 vaccine doses by mouth. Study procedures     include: stool samples, blood samples, and documenting side effects. Participants will be     involved in study related procedures for about 8 months.   "
251450|NCT01147458|"     PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which     is involved in the pathway that causes inflammation and pain. The purpose of this study is to     test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the     knee by itself or with naproxen, particularly to test if patients have less pain.   "
251451|NCT01147471|"     The purpose of this study is to determine whether operative fixation of unilateral flail     chest provides greater benefit than non-operative treatment.   "
251452|NCT01147484|"     The purpose of this study is to find out what effects this new drug foretinib has on this     type of breast cancer, called triple negative breast cancer because the cancer tissue is     estrogen, progesterone and HER2 receptor negative.   "
251453|NCT01147497|"     Because of misoprostol's known ability to cause cervical dilation, some family planning     providers give their patients a dose of this drug prior to insertion. The goal of this study     is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases     insertion and decreases pain.   "
251454|NCT01147510|"     To compare the efficacy of combination therapy of montelukast plus low dose inhaled     budesonide and single therapy of medium dose inhaled budesonide on asthma control such as     inflammatory markers and clinical indicators and to compare treatment response according to     leukotriene related genotypes in elderly patients with asthma   "
251455|NCT01147523|"     The primary aim of the study is the effect of spironolactone and vitamin E versus vitamin E     on serum levels of adipokines 52 weeks post-treatment.   "
251456|NCT01147536|"     Renal cell carcinoma patients' blood will be monitored over a period of 15 weeks to evaluate     their level of immune response to multiple administration of HSPPC-96.   "
251457|NCT01147549|"     The purpose of the study is to characterise the absorption, distribution, metabolism and     excretion (ADME) of a single oral dose of [14C]AZD9668.   "
251458|NCT01147562|"     Lung cancer is responsible for the most deaths due to cancer each year in both men and women     worldwide and once diagnosed, the 10 year survival rate is poor (<15%). This poor prognosis     is based in large part on the absence of an effective diagnostic test for the disease. The     chief objective of this study is to develop a molecular-based diagnostic test specific for     lung cancer. Subjects suspected or diagnosed with lung cancers, who are either undergoing     thoracentesis, biopsy of a suspicious lesion or surgical resection of their tumor will be     asked to participate in this study. Those subjects, who will undergo surgical resection, will     donate both lung tumor tissue and adjacent normal lung tissue (potentially including lymph     nodes), while non-surgical candidates will donate a portion of their excess biopsy sample, if     available, after diagnosis has been confirmed. Subjects undergoing thoracentesis for pleural     effusion will donate a portion of their fluid sample, if the fluid volume collected is in     excess of that needed for clinical care purposes. Blood samples and optionally saliva will     also be collected from all subjects, whether undergoing surgery or not. In addition to     biosample collection, detailed annotated demographic and clinical information will be     collected from subjects. Subjects will be followed for outcome analysis, specifically for     tumor recurrence, every 6 months, during 5 years. In case of change in chemotherapy     treatment, biosamples and clinical information will also be collected. Collected biosamples     will be analyzed using a series of molecular and proteomic technologies for developing     biomarkers of the disease.   "
251474|NCT01147770|"     The objective of this study is to evaluate the effect of the prolongation of luteal support     on the ongoing pregnancy rate (beyond 12 weeks of gestation )in recFSH/GnRH antagonist     cycles.   "
251475|NCT01147783|"     The aim of the present study is to compare radiographic upper airway measurements of the     SimBabyTM pediatric patient high-fidelity simulator with actual human airway anatomy to     assess the grade of realism of the simulator.   "
251459|NCT01147575|"     Creatine supplementation in RTT: a randomized controlled trial      Rett Syndrome (RTT) is a neurodevelopmental disorder characterised by apparently normal early     development (stage 1 of RTT) followed by loss of purposeful hand use, distinctive hand     stereotypes, slow brain growth, loss of language, respiratory irregularities,     gastrointestinal disturbances, gait abnormalities, seizures, and mental retardation. These     symptoms typically appear between 6 and 18 months of age (stage 2). Subsequently, there is     gradual stabilisation of severe mental retardation and motor compromise (stage 3). The     majority (70% to 80%) of patients show mutations in the methyl-CpG-binding-protein-2 (MeCP2)     gene, located on chromosome Xq28. MeCP2 encodes a transcription repressor protein that is     ubiquitously expressed in all tissues.      As RTT primarily affects females, only very few males with mutations in MeCP2 have been     identified. Mutations in MeCP2 have also been identified in children with X-linked mental     retardation, autism and a clinical phenotype that resembles Angelman Syndrome.      The aim of this study is to investigate the effects of a dietary supplement on the     biochemical and clinical parameter of RTT. About 80 % of labile methyl groups generated     through the re-methylation cycle are used for the synthesis of creatine within the human     organism. Supplementation of creatine will therefore increase the availability of labile     methyl groups for different methylation reactions including methylation of DNA.      The study will be double blind and cross-over. The patients will get creatine monophosphate     (200 mg/kg/d in three dosages per day) or placebo. After 6 months and a wash-out period of 4     weeks the groups are changed for the next 6 months.      All participants with RTT and mutations in MeCP2 will undergo physical and neurological exam,     quantitative EEG, behavioral assessment, laboratory testing, and neuropsychological     evaluations. Participants will have a follow-up after 3, 6, 10, 13 and 16 months (3 months     after finishing the study), which will include similar assessments.   "
251460|NCT01147588|"     The aim of this study is to determine if there is a pharmacological interaction between     clopidogrel and different types of proton pump inhibitors (PPIs), and if the extent of this     possible interaction would change over time.   "
251462|NCT01147614|"     The purpose of this study is to determine whether a brief (12 week) psychological treatment     program, based in primary care, can help youths struggling with anxiety and/or depression.     This brief cognitive behavioral therapy program will be compared to enhanced referral to     specialty mental health care.   "
251463|NCT01147627|"     The purpose of this study is to investigate and evaluate the effects of different     interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell     function in newly diagnosed drug-naïve type 2 diabetic patients.   "
251464|NCT01147640|"     A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam     (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000     mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose     adjustments for subjects with mild renal impairment are not necessary and subjects with more     severe degrees of renal failure are excluded.   "
251465|NCT01147653|"     The purpose of this study is to determine the efficacy of a single intravenous infusion of     autologous umbilical cord blood (UCB) for the treatment of pediatric patients with spastic     cerebral palsy.   "
251466|NCT01147666|"     The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining     and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease(ESRD)on     maintenance hemodialysis   "
251467|NCT01147679|"     This study is designed to document the loss of sociomoral emotions (like empathy, guilt, and     embarrassment) in patients with behavioral variant frontotemporal dementia. The loss of these     emotions, which function as the motivators for social behavior, will manifest in specific     interpersonal behaviors. These behaviors will correlate with regional changes in regional     changes in medial frontal and anterior temporal lobes. These social and emotional changes     will be compared with a young-onset Alzheimer's disease comparison group.   "
251468|NCT01147692|"     This open-label study evaluates the pharmacokinetics of simvastatin when coadministered with     albiglutide in healthy adult subjects. The primary objective is to assess the effect of     albiglutide doses on the pharmacokinetics of simvastatin.   "
251469|NCT01147705|"     Peripheral arterial disease (PAD) is a common condition that arises due to the build up of     atheroma in the arteries supplying blood to the peripheral muscles and other tissues. This     imbalance between oxygen supply and demand becomes particularly apparent when patients with     the condition are walking. The pain and weakness they experience (mainly in the calf but less     commonly in the thigh) is known as intermittent claudication and resolves upon cessation of     exercise.      It is an important disease to study as it is (i) common (est. prevalence of symptomatic     intermittent claudication in Scotland of 4.5%) and (ii) those with it have a 1.6 times higher     relative risk of ischaemic heart disease. These patients also have a significantly higher     mortality than age-matched controls at around 12% per year.      There are two main aims of therapy - (i) to reduce the risk of cardiovascular events by way     of standard secondary prevention measures (smoking cessation, anti-platelet,     anti-hypertensive and cholesterol-lowering therapy, diabetic control) and (ii) to treat     symptoms.      Supervised exercise therapy has been shown to be beneficial in improving walking time and     distance in selected patients with leg pain from intermittent claudication with an overall     increase in walking distance of approximately 150 metres at three months.      There are numerous drug treatments available for consideration in PAD patients (mainly     cilostazol in the UK), but many of these have either undesirable side effects or no clear     evidence of benefit. The range of increase in walking distance on cilostazol was reported to     be a 50-76% increase over three months compared to 20% with placebo with some significant     improvements in Quality of Life (QOL) indicators, although with a significant number of     adverse effects (16% vs 8% on placebo) limiting therapy. The current cost (March 2010) is     £35.31/month.      Other options for therapy include angioplasty and bypass surgery. At present these are only     recommended for patients who fail to respond to medical therapy and have severely disabling     symptoms (in the absence of significant exercise-limiting comorbidities).   "
251470|NCT01147718|"     This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of     digoxin when coadministered with albiglutide in healthy adult subjects.   "
251471|NCT01147731|"     This open-label study evaluates the pharmacokinetics of warfarin when coadministered with     albiglutide in healthy adult subjects. The primary objective is to assess the effect of     albiglutide doses on the pharmacokinetics of warfarin.   "
251472|NCT01147744|"     To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form     (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in     adolescent and adult subjects (12 years of age and older) with persistent asthma. These data     will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried     forward in Phase III asthma studies. The study also includes Fluticasone Propionate     Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an     exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid     and a leukotriene receptor antagonist.   "
251473|NCT01147757|"     Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic     consumption in pediatric laparoscopic ureteroneocystostomy.   "
251477|NCT01147809|"     The present study is a randomized, blinded, placebo-controlled, two-Phase, sequential cohort,     dose finding study to assess the safety and efficacy of eltrombopag in patients with solid     tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin     or cisplatin. Phase I of the study will examine safety and tolerability of various doses of     eltrombopag to identify a dose and schedule of eltrombopag. Phase II will confirm that the     chosen dose and schedule of eltrombopag from Phase I can deliver clinically meaningful     benefit(s) to thrombocytopenic patients by improving platelet numbers.   "
251478|NCT01147822|"     This study is being conducted to provide a direct comparison of the efficacy, safety, and     tolerabilityfor pazopanib and sunitinib (SUTENT) in the Asian population.   "
251479|NCT01147835|"     Young children with asthma who use drugs for their asthma are at higher risk for tooth decay.     These drugs can cause (1) dry mouth from less saliva secretion and (2) acid mouth that causes     teeth to become soft and bacteria to multiply. Herbal lollipops may reduce the risks of tooth     decay in young children. The purpose of this research is to determine how well herbal     lollipops can improve the negative effects of asthma drugs over a 6-month period. Herbal     lollipops contain Chinese licorice root.   "
251480|NCT01147848|"     The purpose of the study is to compare the efficacy and safety of fluticasone     furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone     propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of     age and older with persistent bronchial asthma over a 24-week period.   "
252041|NCT01156168|"     RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will     respond to treatment.      PURPOSE: This research study is studying biomarkers in tissue samples from patients with     breast cancer treated with bevacizumab.   "
251481|NCT01147861|"     The aim of this study is to verify whether a significant decrease in glucose levels can be     achieved with the HM74A agonist GSK256073 in type 2 diabetic patients. Several dose levels     and a placebo will be evaluated in a three period crossover study with two active doses and     one placebo dose per subject, in order to determine whether there is a dose that produces     glucose lowering in the target population. In addition, this study will investigate the     optimal dosing regimen for full manifestation of any metabolic effect of GSK256073 by     comparing once a day versus twice a day regimens.   "
251482|NCT01147874|"     This is a phase 4, multicenter, randomized, non-therapeutic interventional trial in subjects     with psoriasis looking for the prevalence of psoriatic arthritis. Subjects will be seen and     evaluated by a dermatologist at visit 1 and by a rheumatologist at visit 2. A subset of     subjects will then go on to visit 3 for imaging procedures (x-ray, MRI, and ultrasound).   "
251483|NCT01147887|"     The purpose of this study is to evaluate the effect of 26489112 on the pharmacokinetics     (blood levels) of a combination of 3 drugs administered to healthy volunteers.   "
251484|NCT01147900|"     The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a     dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa     in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to     participate in this study.This protocol posting deals with objectives & outcome measures of     the booster phase. The objectives & outcome measures of the primary phase are presented in a     separate study (see reference).   "
251485|NCT01147913|"     This study will examine how well a novel four-session computerized program, designed to help     adolescents learn to interpret ambiguous situations less negatively, reduces symptoms of     depression and decreases negative information-processing biases.   "
251486|NCT01147926|"     This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase     III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment     in male subjects with chronic constipation.      Furthermore the safety, tolerability, effect on quality of life and effect on symptoms of     prucalopride will be assessed.   "
251487|NCT01147939|"     The purpose of the study is to assess the efficacy and safety of elacytarabine versus     investigator's choice treatment in patients with relapsed or refractory acute myeloid     leukemia (AML).   "
251488|NCT01147952|"     Regular exercise is known to produce significant health benefits and to reduce the risk of     heart diseases, although how this benefit occurs is not well understood. White blood cells     are known to be involved in triggering heart attacks, and which genes are switched on or off     in white blood cells determines whether they have beneficial or harmful effects. Previous     studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood     gene expression (which reflects white blood cell gene expression) is able to distinguish     between patients with and without coronary artery disease, or patients who are able to     develop good compared with poor coronary collateral arteries. Therefore, the gene expression     signature in peripheral blood may provide novel diagnostic or prognostic information, and     insight into the pathogenesis of heart disease.      We therefore hypothesise that exercise alters peripheral blood gene expression in patients     with coronary artery disease and angina. This will identify possible ways that exercise     improves angina and reduces the risk of heart disease.   "
251489|NCT01147965|"     The purpose of this study is to find out what effects (good and bad) that a cancer vaccine     has on you and your cancer. The cancer vaccine is called Ad5 [E1-, E2b-]-CEA(6D)or ETBX-011     and is made by Etubics. This vaccine is based on a virus called an adenovirus but it has been     changed to express the protein CEA that is found on some cancer cells. Therefore, the vaccine     can tell the immune system to attack cancer cells which make CEA. The investigators are     trying to determine whether giving this virus is safe and whether this causes a strong immune     system attack on the cancer. ETBX-011 is an investigational drug.   "
251490|NCT01147978|"     The investigators propose an interventional multicentric (23 ICUs) study measuring the impact     of a consultation at the end of ICU stay for the patients and his/her families on the     prevalence of symptoms of PTSD and anxiety or depression 3 months and one year after     discharge. Patients will be randomly assigned to a intervention or control group. In the     intervention group, the patient and his/her family will benefit from an conference by the     intensivist at the end of the ICU stay, regarding information about the progress of his stay     in ICU, his orientation after discharge, the possibility of consulting a GP, etc. Patients     and proxies will be interviewed by phone three months and one year after discharge from ICU.     Main instruments are Hospital Anxiety and Depression Scale, and Impact of Events Scale     Revised.   "
251491|NCT01147991|"     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective     immune response to kill tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in     treating patients with Epstein-Barr virus and cancer.   "
251492|NCT01148004|"     Background:      - Patients infected with the human immunodeficiency virus (HIV) are often treated with     protease inhibitors that help fight HIV infection. However, these medications often increase     blood cholesterol levels, particularly triglycerides and low-density lipoproteins, and can     lead to heart disease and other problems. Patients may take drugs known as fibrates (such as     gemfibrozil (Lopid )) to lower triglyceride levels, but even with maximum approved doses     patients often cannot reach goal triglyceride levels. Research suggests that fibrates and     certain HIV medications, such as ritonavir and lopinavir/ritonavir, may interact and decrease     the effectiveness of the fibrate treatment. More research is needed to determine the best     drug to lower triglyceride levels in HIV patients who are receiving protease inhibitor     therapy.      Objectives:      - To evaluate the drug-drug interaction between fenofibrate and protease inhibitors     lopinavir/ritonavir and ritonavir.      Eligibility:      - Healthy individuals between 18 and 60 years of age.      Design:        -  This study will require a screening visit and 18 study visits. The screening visit will          take 3 to 4 hours, and can occur 7 to 30 days before starting the study. The rest of the          study, not including the screening visit, is 48 days. Three of the visits will take          about 12 hours, and the remaining 15 visits will take about 1 hour.        -  For study days 1 to 7, participants will take fenofibrate alone. Participants will keep          a daily record of medication doses and any side effects.        -  For study days 8 to 27, participants will take fenofibrate and ritonavir. Participants          will keep a daily record of medication doses and any side effects.        -  For study days 29 to 48, participants will take fenofibrate and lopinavir/ritonavir.          Participants will keep a daily record of medication doses and any side effects.        -  Participants will have regular study visits to provide blood samples for research and          monitoring....   "
251493|NCT01148017|"     The primary objective was to evaluate the persistence of bactericidal antibodies in children     40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received     Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have     never received any meningococcal vaccine (naïve subjects) to serve as a control group. In     addition, the response of a booster dose at 60 months was evaluated.   "
251494|NCT01148030|"     Patients presenting in the Emergency Department or admitted to the hospital with displaced     hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal     instability/fractures in need of urgent surgical intervention will receive treatment to     reduce the number of microorganisms in their nose prior to surgery. After surgery, the     subjects will be observed for any surgical site infections.   "
251495|NCT01148043|"     The purpose of this study is to determine the efficacy of hydroxychloroquine in hand     osteoarthritis.   "
251496|NCT01148056|"     This study will investigate short course radiation therapy using IMRT as an alternative to     standard chemo radiation because prior studies have shown that this method of treatment will     potentially reduce some fo the side effects of standard treatment, improve quality of life,     and help to control the growth of rectal cancer cells. IMRT is a type of radiation that uses     computer-generated images to match radiation to the size and shape of the tumor. Since the     intensity of each radiation beam can be controlled, the radiation dose can wrap around normal     tissue which allows the study doctor to deliver a higher dose of radiation to the tumor with     less damage to nearby healthy tissue. The purpose of this research study is to see what     impact this treatment will have on quality of life, as well as to see if there are any late     side effects that come about after the participant has completed the treatment.   "
251497|NCT01148069|"     Standard treatment of locally-advanced prostate cancers consists in the association of     radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years.     This treatment is usually preceded by pelvic lymphadenectomy to assess the possible extension     to lymph nodes of prostatic cancer and to avoid irradiating the pelvis in case of no lymph     node involvement. However, radiotherapy leads usually to about 30% of grade ≥2 risk of     bladder and/or rectal toxicity. This risk particularly depends on the radiation volume. In     the aim of lowering the toxicity, the treatment in this study will associate:        -  pelvic lymph node dissection and resection of seminal vesicles, allowing decreasing the          radiation target volume to the prostate only (and not to irradiate the SV);        -  a high-precision radiotherapy technique combining Intensity Modulated Radiation Therapy          (IMRT) and Image-Guided Radiation Therapy (IGRT).   "
251498|NCT01148082|"     The purpose of this research is to investigate school response to families who have children     with cancer. It is anticipated that the results of this study will enhance the support that     schools can give to the population of families who have a child with cancer. The study will     involve the parents in these families, the principal and an educator in the school of the     child with cancer. Measurement tools will include surveys, interviews, and other relevant     educational and medical documents.   "
251499|NCT01148095|"     AZD2516 is being developed for the oral treatment of chronic neuropathic pain. This study is     split in to two parts. Part A will measure the effect of food and a new formulation of the     drug in the blood and see how well it is tolerated. Part B will commence after the completion     of Part A and will investigate the safety and tolerability of daily dosing with AZD2516.   "
251500|NCT01148108|"     This is a Phase 2 study to determine the efficacy and safety of canfosfamide treatment in     relapsed or refractory mantle cell lymphoma, diffuse large B cell lymphoma and multiple     myeloma. The study will be conducted in two stages with 5-6 patients in each indication in     Stage 1 and if responses are observed an additional 10 patients in Stage 2 in each group.   "
251501|NCT01148121|"     This study may provide information that may serve as the foundation for a larger research     study to address issues regarding the causes, diagnosis, and treatment of osteoporosis in the     Down syndrome patient population.   "
251502|NCT01148134|"     This study is characterizing the pharmacokinetics of vincristine using two different cohorts     of patients. The first cohort includes patients with acute lymphoblastic leukemia (ALL) that     are Bcr-Abl positive. This cohort of patients will receive vincristine along with imatinib in     the induction chemotherapy regimen. The second cohort includes patients with ALL that are     Bcr-Abl negative. This cohort of patients will receive vincristine without imatinib in the     induction chemotherapy regimen. This study involves blood draws beginning on day 7 of the     treatment protocol and these samples will be analyzed for pharmacokinetic parameters.      Imatinib and vincristine are both metabolized by the hepatic CYP 450 enzyme system. Imatinib     is an inhibitor of the system and co-administration of imatinib and vincristine has the     potential to increase the blood level of vincristine. This could explain the increased level     of neurotoxicity that is currently being seen with the co-administration of these two agents     in the treatment of Bcr-Abl positive ALL.   "
251503|NCT01148147|"     Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of     adenosin in elective patients undergoing coronary angioplasty.   "
251547|NCT01148745|"     The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and     ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as     well as to determine the point at which serum ferritin and TSAT concentrations can be checked     in iron deficiency anemia (IDA) hemodialysis patients.   "
251504|NCT01148160|"     Multiple factors are associated with a large variability in voriconazole exposure following     standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug     interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes.      Voriconazole is extensively metabolized by the human hepatic enzymes, primarily mediated by     CYP2C19. The polymorphisms account for a relatively large portion of inter-individual     variance observed in voriconazole plasma concentrations.      However, there are limited data on the relationships between voriconazole blood levels and     clinical outcomes or safety in Asian populations.      The purpose of this study is to investigate the relationships of voriconazole blood levels     with genetic polymorphism, safety, and clinical outcomes in immunocompromised patients with     invasive pulmonary aspergillosis.   "
251505|NCT01148173|"     Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating     complication. There is no therapy standard, conventional approaches are palliative. This     study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose     chemotherapy and autologous stem cell transplantation as a potentially curative approach.   "
251506|NCT01148186|"     An educational intervention targeting community-dwelling older adults will lead to a     reduction in potentially inappropriate prescriptions (e.g. benzodiazepines, oxybutynin).      Cessation of potentially inappropriate medications (e.g. benzodiazepines, oxybutynin)will     lead to improved cognitive outcomes in older adults.   "
251507|NCT01148199|"     Biliary complications are one of the most common problems after orthotopic liver     transplantation (OLT),occurring in up to 24% of patients.      Anastomotic strictures have been endoscopically managed with plastic stents placement.     Recently, partially and fully covered metal stents have been alternatively used to treat     refractory benign biliary stenosis. The investigators purpose is to compare efficacy and     safety of metallic stents versus multiple plastic stents in the endoscopic management of post     transplant biliary complications.   "
251508|NCT01148212|"     Testing safety and tolerability of transcranial direct current stimulation (2 mA, 20 minutes)     in four different protocols:      saline-soaked sponges electrode with electrode gel tap-water-soaked sponges     tap-water-soaked-sponges + sham stimulation      Outcome measures are tolerability (comfort rating questionnaire), impedances, skin elasticity   "
251509|NCT01148225|"     There is an unmet medical need in non-infectious intermediate-, posterior- and pan uveitis.     These types of uveitis are at a higher risk for vision loss compared to anterior uveitis.     Patients with these types of uveitis are often treated with chronic corticosteroids. The use     of chronic corticosteroids is linked with predictable long-term side effects. The objective     of this study is to evaluate the long term efficacy and safety of adalimumab subjects with     non-infectious intermediate-, posterior- or pan-uveitis.   "
251510|NCT01148238|"     Autoimmunity is the main cause of diabetes type 1 and an important factor as cause of Latent     Autoimmune Diabetes in Adults (LADA). Recently, research has found that being deficient of     T-reg cells is an important cause of autoimmunity. The study hypothesis are:        1. Patients with newly found diabetes type 1 have less T-reg than healthy.        2. Patients with newly found diabetes type 1 have less T-reg than patients with long          duration of the illness.        3. The number of T-reg is negative associated with HLA-risk-haplotype.        4. The number of T-reg is negative associated with LADA.        5. Differences relating to inflammatory cytokines will be seen among patients with newly          found diabetes type 1, but not among others.   "
251511|NCT01148264|"     This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment     of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and     aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified     MASCC questionaire with a visual analog scale.   "
251512|NCT01148277|"     This is a prospective, randomized-controlled trial (RCT) comparing the use of Propofol and     Remifentanyl and traditional sedation (Midazolam and Fentanyl) for diagnostic colonoscopies     in patients with compensated cirrhosis child A-B. The working hypothesis is that the use of     propofol will be translated in a shorter recovery and discharge times with a higher patient     satisfaction and a decrease in general complications (Hepatic Encephalopathy) in the context     of patients with advanced liver disease.   "
251513|NCT01148290|"     The surgical treatment of vulvar cancer is characterized by a radical approach as standard,     often associated to an important rate of functional complications. This surgery often     includes the partial excision of urethra, resulting in a reduction of urethral closure     pressure. The radiotherapy-induced fibrosis in addiction leads to a reduction of urethral     mobility. As consequence women treated for vulvar cancer may develop urinary incontinence.     The incidence of this complication has been differently reported, but seems to reach the     100%. Poor data are available regarding the treatment of post vulvectomy urinary incontinence     and no clear indication may be given at regards.      Based on these considerations the aim of this trial will be to compare tension free vaginal     tape and bulking agent injection in women with urinary stress incontinence developed after     radical surgery for vulvar cancer.   "
251514|NCT01148303|"     The investigators intend to study whether the use of the pain medication etoricoxib (Arcoxia)     taken just before the Ramadan fast will prevent or lessen headache that some people get while     fasting. The investigators hypothesize that etoricoxib will reduce the number of people     getting headache, more than placebo. The investigators will do this by giving participants in     the study either real medication or placebo (sugar pill) and comparing the results. The     investigators will study this over two weeks. The first week one group will get the medicine     and the other the placebo. The second the groups will switch. Neither the subjects nor the     investigators will know who is in which group.   "
251524|NCT01148433|"     The present non-interventional study is to document the testosterone levels in patients with     clinical symptoms such as loss of sexual desire indicating hypogonadism (testosterone     deficiency syndrome). During testosterone replacement therapy with TESTIM®, the changes in     the quality of life - especially with respect to motivation, activity and fatigue - of     hypogonadal patients will be documented and correlated with the testosterone levels during     the course of therapy.   "
251525|NCT01148446|"     The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (>65     years) with Diffuse Large B Cell Lymphoma (DLBCL).   "
251526|NCT01148459|"     The purpose of this study is to assess the safety and immunogenicity of the candidate malaria     vaccine in HIV-infected infants and children   "
251515|NCT01148316|"     Obsessive-compulsive disorder affects approximately 2% of the population, frequently has its     onset during childhood or adolescence and is potentially incapacitating. If not properly     treated, this disorder tends to follow a chronic course. Pharmacotherapy with clomipramine     and selective serotonin reuptake inhibitors (SSRIs), such as fluvoxamine, fluoxetine and     sertraline, has been approved for pediatric OCD. However, up to 30% of patients may not     benefit from these treatments, and the presence of residual symptoms is frequent among     treatment responders. Cognitive-behavioral therapy (CBT) is also recognized as first line     treatment for pediatric OCD, either administered in individual or group format. There is     evidence suggesting equivalent efficacy for SSRIs and CBT in pediatric OCD, but there is no     data on adaptive treatment strategies regarding such treatments on the long term outcome of     OCD patients. The aim of this study is to verify, in a randomized design, if there is an     optimal sequential treatment strategy for pediatric OCD, adopting the two most studied     treatments for this disorder: an SSRI and group CBT (GCBT). The investigators hypotheses are:     (1) both types of treatment will present similar efficacy in the short term (14 weeks); (2)     for non-responders to the first type of treatment (fluoxetine up to 80mg/day or GCBT for 14     weeks), combined treatment (fluoxetine + GCBT for another 14 weeks) will be more effective     than switching treatment modality (from fluoxetine to GCBT or from GCBT to fluoxetine for     additional 14 weeks) after additional 14 weeks.   "
251517|NCT01148342|"     Background:        -  3,4-Methylenedioxymethamphetamine (MDMA), commonly known as ecstasy, is a synthetic          psychoactive drug that has shown a steep increase in recreational use and abuse by young          people in recent years. Research studies have reported that chronic MDMA users who also          consume other legal and illegal substance show memory deficits; however, because of the          combination of drugs often involved, it is difficult to determine MDMA s contribution to          these effects.        -  Only a few studies have examined the immediate physical and behavioral effects of MDMA          given at dose levels commonly used in young adults. Researchers are interested in using          functional magnetic resonance imaging (fMRI) to examine changes in brain activity and          function in MDMA users compared with users of other drugs and non-drug-using          individuals.      Objectives:      - To evaluate the effects of MDMA on thinking and brain function.      Eligibility:      - Individuals between 18 and 30 years of age who are (1) current users of MDMA (2), current     drug users who do not use MDMA, or (3) healthy non-drug-using volunteers.      Design:        -  Participants will complete one training session and three scanning sessions.        -  Before the start of the study, participants will complete questionnaires about medical          and psychological history, and provide information about past or current drug use.          Researchers will introduce the tasks to be performed during the scanning session(s), and          will allow participants to practice the tests.        -  Participants will provide urine, saliva, and hair samples for testing before the start          of the study, and multiple times during each scanning session.        -  Participants who use MDMA and participants who use other drugs will stay overnight at          the clinical center prior to each scanning session. Participants who do not use drugs          can spend the night prior to scanning or arrive at the clinical center on the morning of          the scanning session.        -  Participants who use MDMA will receive either MDMA or a placebo during the scanning          sessions, and will not be told which one they have received. Because of the nature of          MDMA, participants will be required to stay at the clinical center until the effects of          the drug have worn off, and will be required to return to the clinical center on the          following day for a follow-up examination.        -  During the study, participants will be asked to do one or more tasks selected by the          researchers. The tasks will be performed on a computer in an MRI machine, and may          involve receiving monetary rewards for actions, memory and reaction-time tests, or other          tests that involve responding to instructions on the screen.   "
251518|NCT01148355|"     Background:        -  Multiple social, psychological, and environmental factors contribute to adolescents' use          of cigarettes. Environmental smoking cues have been shown to play an important role in          the maintenance of nicotine addiction and in relapse to smoking. However, few studies          have examined craving and cue-reactivity in adolescent smokers, even though craving          appears to contribute to ongoing smoking and relapse in this age group.        -  Another factor central to addiction is the rewarding effect of drugs, or the interaction          between the person, the drug, and the environmental setting. However, more research is          needed on whether environmental cues lead to increased smoking in adolescents.      Objectives:      - To determine the effects of smoking versus neutral cues in adolescents who smoke on (1)     craving, mood, and autonomic responsivity and (2) the relative reinforcing efficacy of     tobacco cigarettes.      Eligibility:      - Adolescents 12 to 17 years of age who are current smokers (at least five cigarettes per day     for the past 6 months).      Design:        -  This study will involve three study visits. Participants will be allowed to smoke before          all study sessions and will give a breath carbon monoxide (CO) sample before all          sessions. Participants must not use any illicit drugs or alcohol 24 hours before          sessions.        -  Visit 1 (baseline session): Participants will provide a urine sample and will be          familiarized with the study room and session design.        -  Visits 2 and 3: Participants will be connected to physiological recording devices to          measure heart rate, perspiration, and other physical responses. After baseline readings,          participants will be exposed to smoking cues at one experimental session and to neutral          cues at the other experimental session.        -  Before, during, and after cue presentation, participants will complete self-report          measures of mood and craving and have physiological measures taken. They will then be          re-exposed to smoking or neutral cues and engage in a self-administration procedure to          examine the effect of cues on the reinforcing efficacy of cigarettes.   "
251519|NCT01148368|"     The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and     the safety of fimasartan in renal impairment patients and healthy volunteers.   "
251520|NCT01148381|"     The influence of genes on addictive and neuropsychiatric disorders is complex, especially     given that multiple genes likely influence certain behaviors that are correlated with     addiction. Researchers are interested in looking at the genetic information of individuals     who are enrolled on National Institute for Drug Abuse studies to investigate specific genetic     variants that may be related to substance abuse. Researchers will study the effects of genes     on several aspects of thinking such as attention, memory, decision making, problem solving,     learning, and emotional feelings, and investigate the ways in which genetic information     affects addictive behaviors and substance abuse. In addition, researchers will study how     genes may explain differences in imaging data in substance users.      Objectives:      - To collect genetic information for research on genetic aspects of addiction and substance     abuse.      Eligibility:        -  Adolescents and adults between 13 and 55 years of age who are (1) healthy,          non-drug-using nonsmokers, (2) healthy smokers, (3) healthy individuals dependent on          other commonly abused drugs, and (4) individuals with other psychiatric disorders.        -  Participants must be right-handed, and must be enrolled in another National Institute on          Drug Abuse, Intramural Research Program imaging protocol.      Design:        -  This study involves one to two visits to National Institute on Drug Abuse, Intramural          Research Program that may be separate from the participant s current research protocol          study visits or on the same day as those visits. .        -  Participants will provide a blood sample and complete questionnaires about mood, memory,          and learning.        -  Participants may also be asked to do a few tasks, such as playing computer games          involving coin tosses and money management, or responding to questions on a computer          screen.   "
251521|NCT01148394|"     Introduction: Multimodal rehabilitation (MMR), combines various elements in the management of     the surgical patient which lead to a decrease in surgical stress and a more comfortable and     faster postoperative recovery.      Objective: To assess the introduction of MMR in a specialized Colorectal Unit and compare the     results with the traditional model assessing its´ efficacy as to recovery, and reduction of     hospital stay and costs.   "
251522|NCT01148407|"     Blood samples on persons with cancer will be sampled for angiogenic, metastatic and     coagulation proteins.   "
251523|NCT01148420|"     The purpose of this study is to investigate the effectiveness and acceptability of high dose     MPA (20mg oral 3 times a day) for 3 days combined with an injection of DMPA 150 mg     intramuscularly in the treatment of acute heavy, prolonged uterine bleeding who have been     identified as being eligible for outpatient management   "
251780|NCT01152567|"     The planned Study will be a retrospective study on the effect of ACE's vs. candesartan on     cardiovascular events and on health economic effects in a real life setting in Sweden.   "
251528|NCT01148485|"     There are only very few data about the prevalence of CA-MRSA in France and no in athletes. In     USA, the clone USA300 is widely disseminated and in Europe the clone ST80 predominates. The     aim of the study was to study the carriage of S. aureus in athletes in a French county     (Limousin) and to evaluate the proportion of CA-MRSA. The athletes will be met during their     training, each one will fill-in a clinical information questionnaire. Nasal, throat, inguinal     and skin lesions swab samples will be performed. The antibiotic susceptibility profile of the     Staphyloccocus aureus strains isolated will be performed as well as the detection of the PVL     gene. Strains will also be typed by different molecular methods (PGFE (Pulsed Gel Field     Electrophoresis), SCCmec type (Staphylococcal Chromosome Cassette mec), and MLST (MultiLocus     Sequence Typing)). The CIC (Clinical Investigation Center) of the Limoges University Hospital     will be in charge of the inclusions of the athletes. The sample analysis will be centralized     and performed at the Laboratory of Bacteriology of the Limoges University Hospital. A     Clinical Research Officer of the Limoges University Hospital will be in charge of the survey     of the study and will organize monthly meetings with all the participants of the study.   "
251529|NCT01148498|"     The purpose of this trial is to compare the average change in the amount of amyloid beta     species in blood after an infusion of solanezumab.   "
252069|NCT01156532|"     Adalimumab has recently been authorized for active psoriasis in Peru and local experience is     very low. The aim of this study is to obtain Peruvian data of clinical effectiveness and     impact on health-related quality of life with the use of adalimumab in participants with     chronic plaque psoriasis complying with the dosing and monitoring recommendations of the     local approved label.   "
251530|NCT01148511|"     The purpose of the study was to compare 2 treatment regimens for patients suffering from     choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first     treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and     than re-treatment of patients who have a visual loss of more than 5 letters with monthly     control (Treat and Observe). The second treatment regimen was 1 injection each month for 3     months and than extending the control period if the macula is dry during the monthly control     (Treat and Extend). If the Treat and Extend regimen is found effective and safe, the number     of ranibizumab injections, the number of patient visits, the risk of adverse events due to     the intravitreal injections, and policlinic occupation number could all be reduced.   "
251531|NCT01148524|"     This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence     at 18 months after the vaccination course in study V72P10 (NCT00661713).      Subjects who participated in study V72P10, and who meet all other enrollment criteria for     this extension study, and a group of naïve subjects (defined as subjects who had never     received rMenB+OMV NZ or other experimental MenB vaccines) of similar age to the subjects who     were eligible to participate in this extension study, performed one study visit in which a     single blood sample was drawn for MenB serological analyses.   "
251532|NCT01148537|"     The purpose of this study is to examine the effect of buprenorphine on QT interval corrected     for heart rate (QTc) in healthy subjects.   "
251533|NCT01148550|"     The specific aims of this study are (1) to determine the clinical phenotypes and natural     history of hepatic RC and FAO disorders, (2) to determine the correlation between genotype     and phenotype, (3) to determine if circulating biomarkers reflect diagnosis and predict liver     disease progression and survival with the native liver, (4) to determine the clinical outcome     of these disorders following liver transplantation, and (5) to develop a repository of serum,     plasma, urine, tissue and DNA specimens that will be used in ancillary studies. To accomplish     these aims, the ChiLDREN investigators at clinical sites (currently 15 sites) will     prospectively collect defined data and specimens in a uniform fashion at fixed intervals in a     relatively large number of subjects. Clinical information and DNA samples to be collected     from subjects and their parents will enhance the potential for meaningful research in these     disorders. A biobank of subject specimens and DNA samples will be established for use in     ancillary studies to be performed in addition to this study.   "
251534|NCT01148563|"     The purpose of this research study is to see whether a tele-health intervention can improve     health, functioning status, emotional status, quality of life, and patient satisfaction for     patients with Congestive Heart Failure (CHF) and to examine the cost benefits of this     intervention.   "
251535|NCT01148576|"     To investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in     chronic hepatitis B patients.   "
251536|NCT01148602|"     To reduce door-to-needle times in acute stroke treatment. Using an organizational behaviour     intervention (a large stopwatch), we will post a visual cue to remind all parties that time     is brain. We hypothesize that this simple visual cue will improve door-to-CT scan times and     door-to-needle treatment times, and thus improve treatment response, and reduce adverse     events.   "
251537|NCT01148615|"     Primary Objective:        -  To confirm the dose of aflibercept in western studies by assessing the dose-limiting          toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with          docetaxel given intravenously every 3 weeks in Chinese patients with solid tumors.      Secondary Objectives:        -  To assess the safety profile of intravenous (IV) aflibercept when administered in          combination with docetaxel        -  To determine the pharmacokinetics of IV aflibercept and docetaxel when administered in          combination        -  To make a preliminary assessment of antitumor effects of the combination of docetaxel          plus aflibercept in patients with evaluable disease        -  To evaluate the immunogenicity of IV aflibercept        -  To measure endogenous free Vascular Endothelial Growth Factor (VEGF)   "
251538|NCT01148628|"     This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the     Maximum Tolerated Dose (MTD) and the Recommended Dose (RD) of the combination RAD001     (escalating daily dose) and CaelyxTM (fixed dose) to patients with advanced solid tumors.      Other purposes of the study are:        1. define the safety profile of the combination after repeated administrations        2. define hints of antitumor activity, to be confirmed in subsequent disease-oriented          expansion phases at the RD.        3. define the pharmacokinetic profile of the combination   "
251548|NCT01148758|"     This exploratory, open label study will assess the the dose-effect relationship, efficacy and     safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian     cancer. Cohorts of patients will receive doses of intravenous RO5323441 in the range of 25mg     to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance     imaging (DCE-MRI) assessments. In the absence of disease progression and unacceptable     toxicity, patients may continue to receive their maximum dose of RO5323441 for a core     treatment phase of up to a total of 6 months. Treatment with RO5323441 can be extended at the     investigator's discretion until disease progression or unacceptable toxicity occurs. Target     sample size is <100.   "
251539|NCT01148641|"     This study aims to assess the acceptability of lipid-based nutrient supplements (LNS) for use     as nutritional supplements for infants and young children in Guatemala.      The study will be conducted in three phases. Phase 1 will be a test-feeding to compare the     acceptability of two different flavors of LNS (peanut and cinnamon) in infants and young     children and their mothers or caregivers in terms of taste, smell and texture, as well as     amount of the test-dose consumed. In Phase 2, children in the Phase 1 trial will receive a     2-week supply of one of the LNS products, which they will consume daily in their homes for 14     days under real-life conditions. Direct observation of supplement use and in-depth interviews     with mothers, caregivers and health staff providing services in communities will be part of     this phase too. In Phase 3, focus group discussions will be held with participants (mothers     and caregivers) as well as with health staff providing services in communities to discuss     different aspects of infant and child feeding and best ways for the LNS product to be used in     the context of Guatemala.      We hypothesize that both flavors of LNS will be accepted by Guatemalan infants and young     children children and their mothers or caregivers.   "
251540|NCT01148654|"     Preterm birth (PTB) is a leading contributor to perinatal morbidity and mortality. While     patients with preterm labor (PTL) are at an increased risk for PTB, not all PTL patients will     deliver preterm. In patients with PTB, there is a high prevalence of 'intrauterine     inflammation' as demonstrated by a large body of evidence. The presence of inflammation is     noted by infiltration of inflammatory cells in the placenta and/or maternal fever in labor     and/or elevation of cytokines in the amniotic fluid.      Despite this significant association of inflammation with PTB, identification of women     destined to deliver preterm by inflammatory markers in maternal blood has not been     successful. To date, it has been difficult to determine which patients with PTL will     experience PTB. Identification of biomarkers, such as high sensitivity C-Reactive Protein     (hsCRP) as well as others such as sICAM, Pentraxin, sE-Selectin, and CxCL-10 in maternal     serum and in placental cord blood, may help to serve three very important clinical aims. 1)     Identification of novel biomarkers in maternal serum could help to distinguish those women     with PTL who are most likely to deliver PTB. 2) These biomarkers may have a high negative     predictive value and thus identify those women who are not likely to deliver preterm,     avoiding undue hospital admission and medical therapies. 3) Select biomarkers in the mother     and/or in cord blood may serve to identify those preterm neonates at greatest risk for     adverse outcome. Through improved identification of these infants, studies with targeted     therapies to reduce adverse neonatal outcomes in preterm neonates become feasible.      This study involves a cohort assessment of women at risk for Preterm birth secondary to     preterm labor, preterm premature rupture of membranes (PPROM), and cervical insufficiency     (CI), between 22-0/7 and 33-6/7 weeks gestational age. We will obtain information regarding     patients' pertinent past medical and obstetric history as well as small samples of maternal     blood at up to four occasions, small samples of placental cord blood, a maternal saliva     sample, and an infant buccal swab. We will follow each of these patient's pregnancy outcomes,     and determine if there are any correlations between levels of certain biomarkers and latency     to delivery as well as composite adverse neonatal outcomes. In women with PTB < 37 weeks,     cord blood will be collected (as well as maternal saliva and an infant buccal swab) and     biomarkers compared between those infants with and without specific adverse neonatal     outcomes. Maternal saliva and buccal will be collected on all women and infants enrolled.   "
251541|NCT01148667|"     Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic     dermatitis. In addition to balancing the gut microecology and promoting host immune defences,     specific probiotics might further aid in controlling the microbial colonization of the skin,     thereby reducing proneness to secondary infections which typically cause sustained symptoms.      Thirty-nine infants with atopic dermatitis,randomized for a three-month-period in a     double-blind design to receive extensively hydrolysed casein formula (NutramigenR,     Mead-Johnson, USA) supplemented with (n=19) or without (n=20) Lactobacillus rhamnosus GG     (ATCC 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu.      Sampling (blood and faecal samples, cotton swab from the skin) and clinical examination of     the infant, including SCORAD assessment to determine the severity of atopic dermatitis, at     each study visit (at entry and one month and three months thereafter).   "
251542|NCT01148680|"     Efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin     therapy for 2 categories of patients: patients with unstable diabetes and patients who     underwent kidney transplantation.   "
251543|NCT01148693|"     Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary     strictures and stenosis is one of important risk factors for post-ERCP cholangitis. Adding     antibiotics to contrast media has proposed in some studies for prevention of cholangitis but     remains controversial. In this study we compare effect of adding gentamicin versus placebo in     preventing cholangitis in patients who undergone endoscopic stenting for non-calculus     strictures and stenosis.   "
251544|NCT01148706|"     To assist in guiding a rigid interventional instrument percutaneously, to a designated point     within the body by means of CT visualization.   "
251545|NCT01148719|"     Background of the study:      Many elderly suffer from reduced exercise tolerance or exercise induced shortness of breath     (dyspnoea) which causes decreased mobility and restrictions in physical, psychological and     social functioning. Patients commonly attribute this symptom to their age, and simply adjust     their life style to it. Reduced exercise tolerance/dyspnoea is very common with prevalence     rate of 20-60% of those aged 65 years and over. The main causus in the elderly are heart     failure and chronic obstructive pulmonary disease (COPD). Both diseases have a high negative     impact on the quality of life and are associated with frequent hospital admissions.     Over-diagnosis, but more often under-diagnosis of heart failure and COPD is rather common in     primary care. Establishing a diagnosis early in the course of the disease is useful because     both diseases can be adequately and evidence-based treated. Therefore, an easy diagnostic     triage-strategy followed bij direct treatment would be of great importance to asses and treat     heart failure and COPD in elderly patient with shortness of breath.      Objective of the study:      Quantify how many frail elderly aged over 65 years with reduced exercise tolerance and/or     exercise induced dyspnoea have previously unrecognised COPD and heart failure. Quantify the     difference in prevalence of unrecognised COPD and heart failure between those who underwent     the diagnostic triage compared to those who received care as usual. Quantify the effect of     the diagnostic triage plus the additionally treatment changes on functionality and quality of     life after 6 months compared to those who received care as usual. Quantify the     cost-effectiveness of the diagnostic triage strategy compared to care as usual      Study design:      A clustered randomized diagnostic (follow-up) study      Study population:      First, pre-selection of patients aged over 65 years from 50 general practices is based on     frailty. Frailty is based on the next criteria: use 5 or more different types of medical     drugs chronically in the last year and/or have 3 or more chronic or vitality treating     diseases (such as diabetes mellitus, COPD, heart failure, impaired vision). This will be done     from the electronic medical files of the general practices. These elderly will receive the     MRC questionnaire of dyspnoea and three additional questions related tot exercise     intolerance. Those with any dyspnoea and/or reduced exercise tolerance will be invited to     participate, except those with established heart failure and COPD.      Study parameters/outcome of the study:      Prevalence of latent heart failure and COPD. Difference in prevalence of latent heart failure     and COPD between both groups.      Differences in functionality and quality of life after 6 months between both groups.     Cost-effectiveness and experienced patient burden of the diagnostic triage strategy.   "
251546|NCT01148732|"     Reliable endotracheal tube (ETT) insertion confirmation is essential for critically ill     patients. Incorrect placement causes a high rate of mortality and morbidity. Therefore, early     detection of accidental esophageal intubation must be a primary focus of emergency airway     efforts in emergency department (ED). Although many techniques have been suggested to verify     the ETT placement, there is currently no entirely reliable method. Ultrasonography (US) is an     indispensable and easily accessible tool in ED. Several studies of ultrasonographic     confirmation of ETT position provided promising results in cadaver model or patient in a     controlled operating room setting.In this study, the investigators have proposed a protocol     called T.R.U.E, an acronym for tracheal rapid ultrasound exam, to confirm the ETT position in     emergency intubation. This method provided a fast, real-time examination to prevent     esophageal or endotracheal intubation.   "
251549|NCT01148771|"     The purpose of this study is to characterize and compare the concentration-time profiles and     multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily     versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and     pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and     compared.   "
251550|NCT01148784|"     The purpose of this study is to compare two different soft tissue allografts, double bundle     tibialis anterior allograft or quadruple bundle hamstring allograft, used in repairing a torn     anterior cruciate ligament (ACL) of the knee.   "
251551|NCT01148797|"     A study designed to evaluate the role of treatment with a biological agent - Canakinumab in     pediatric (age 4-20) Familial Mediterranean Fever (FMF) patients that are intolerant or     resistant for colchicine treatment.      The study hypothesis is that Canakinumab will reduce attack frequency and severity.   "
252110|NCT01157065|"     The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as     measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a     single intravitreal injection, as compared to LUCENTIS.   "
251552|NCT01148810|"     This study will determine the efficacy, safety, tolerability and the PK profile of BAF312, a     novel immunomodulator, in polymyositis and dermatomyositis patients that are not responsive     to traditional immunosuppressive and/or corticosteroid therapy. The study will consist of a     12 week, randomized, placebo controlled period, followed by another 12 weeks where all     subjects will receive BAF312 treatment.   "
251553|NCT01148823|"     This randomized clinical trial was designed to assess the influence of time of dressing after     breast reconstruction procedures on surgical site infections rates and skin colonization.   "
251554|NCT01148836|"     The purpose of this study is to evaluate the effects of Coenzyme Q-10, an antioxidant, in the     treatment of pulmonary hypertension.   "
251555|NCT01148849|"     The purpose of this study is to determine if MGAH22 is safe when given by intravenous (IV)     infusion to patients with HER2-positive cancer. The study will also evaluate how long MGAH22     stays in the blood and how long it takes for it to leave the body, what is the highest dose     that can safely be given, and whether it has an effect on tumors.   "
251556|NCT01148862|"     The purpose of this study is to assess the efficacy of the Low Glucose Suspend (LGS) feature     in reducing hypoglycemia with the MiniMed Paradigm® X54 System with hypoglycemic induction     from exercise.      The study will consist of a total of 50 subjects, age 16 through 60 years with Type 1     Diabetes Mellitus.   "
251557|NCT01148875|"     RATIONALE: Mammography reminders may encourage women to undergo regular mammography     screenings for breast cancer.      PURPOSE: This randomized clinical trial is studying three different mammography reminder     interventions to compare how well they work in encouraging women to undergo regular     mammography screenings for breast cancer.   "
251558|NCT01148888|"     The primary objective of this study is to determine whether magnesium sulfate has a     clinically important effect on the amplitude and latency of somatosensory and motor evoked     potentials in patients undergoing surgical correction of idiopathic scoliosis.   "
251559|NCT01148901|"     This trial is designed to measure improvement of hip involvement in patients with ankylosing     spondylitis (AS) after receiving 4 doses of infliximab. Participants will receive infliximab     5 mg/kg (as an intravenous perfusion over a period of 2 hours) at Weeks 0, 2, 6, and 14,     consistent with the approved dosing regimen described in the label. Participants will be     evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses)     of treatment. Further treatment after 4 doses is based on standard clinical practice as     determined by the trial site.   "
251560|NCT01148914|"     This prospective study aims;        1. To assess if pre-ablation levels of inflammatory biomarkers serve as independent          predictors of procedure outcome        2. To evaluate the inflammatory activation following catheter ablation by measuring          serum-biomarker levels 24-hours after the procedure and examine the predictive role in          procedure success        3. To determine if a change in the baseline level of certain inflammatory biomarkers at          3-months post-ablation period has any correlation with the long-term outcome in patients          with atrial fibrillation        4. To study the association of certain biomarkers with specific types of AF (paroxysmal or          persistent or long standing persistent)   "
251561|NCT01148927|"     Acute lymphoblastic leukemia (ALL) accounts for about 20% of adult leukemias. Treatment     results in adult ALL have lagged behind the improvements achieved in the pediatric     population. A modified version of the Dana Farber Cancer Institute pediatric protocol is used     to treat adult patients with ALL. The results seem to be superior to those reported with     other adult protocols. However, there is limited data on the impact of such intensified     approaches and resulting toxicities on the quality of life (QOL) of these survivors.     Identifying important factors affecting the QOL may permit attempts at early interventions     and may help to further modify the regimen and mitigate these adverse effects on QOL.      This study is evaluating the quality of life of long term survivors of adult ALL. It involves     the patients filling out several questionnaires that are well-validated measures assessing     various QOL issues of concern to these patients. The following questionnaires are used in     this study:        -  EORTC QLQ C30 to assess global health and major health domains        -  Brief Pain Inventory (BPI)        -  Personal Health Questionnaire (PHQ9) to assess psychosocial distress        -  Functional Assessment of Cancer Therapy (FACT) Fatigue Questionnaire        -  Peripheral Neuropathy Questionnaire      The data obtained from the questionnaires will be analyzed and the various domains of health     will be quantified.   "
251562|NCT01148940|"     The purpose of this trial is to investigate D-Dimer levels, a surrogate marker of venous     thromboembolism, in pregnant/postpartum white women as compared to pregnant/postpartum black     women, and pregnant/postpartum women with sickle cell trait. The investigators will determine     whether increased D-Dimer levels are reflected in a greater incidence of thrombosis in the     postpartum patient, as well as the prevalence of symptomatic venous thrombosis in black     patients as compared to pregnant white patients and women with sickle cell trait. The     investigators will also investigate the effect of blood group on these parameters. If there     is evidence that there is an increased risk of thrombosis in sickle cell trait, the     investigators will plan a trial of prophylactic anticoagulation during the last trimester and     the four weeks post partum for patients with sickle cell trait and compare this population to     patients who do not receive prophylactic anticoagulation.   "
251563|NCT01148953|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics of a single dose of ALN-TTR01 in patients with transthyretin (TTR) mediated     amyloidosis (ATTR).   "
251564|NCT01148966|"     This phase I trial is studying the side effects and best dose of aminolevulinic acid during     surgery in treating patients with malignant brain tumors. Aminolevulinic acid becomes active     when it is exposed to a certain kind of light and may help doctors find and remove tumor     cells during surgery   "
251625|NCT01143402|"     This randomized phase II trial studies temozolomide to see how well it works compared to     selumetinib in treating patients with melanoma of the eye that has spread to other places in     the body. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Selumetinib may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth. It is not yet known whether temozolomide is more     effective than selumetinib in treating melanoma of the eye.   "
251565|NCT01148979|"     This study aims to test the effect of a newly-approved stimulant medication, lisdexamfetamine     dimesylate (Vyvanse), on specific residual symptoms of depression found in some patients who     are undergoing treatment with, but have only partially responded to, a selective-serotonin     reuptake inhibitor (SSRI) or selective-norepinephrine reuptake inhibitor (SNRI)     antidepressant. Specifically, the investigators hypothesize that symptoms potentially related     to deficient dopaminergic activity, such as lassitude, apathy, reduced positive affect and     impaired executive function, in particular, will improve. This protocol is designed to test     the hypothesis that this cluster of co-occurring residual symptoms sometimes found in treated     depression will respond as a group to adjunctive psychostimulant therapy. The investigators     propose to demonstrate this cluster of residual depressive symptoms and to measure the effect     of stimulant therapy on it. The investigators hope to better understand the specific symptoms     in this clinical population that are likely to improve with stimulant therapy.   "
251566|NCT01148992|"     The purpose of this study is to assess potential interactions between intravenous (IV)     cocaine and treatment with lofexidine.   "
251567|NCT01149005|"     The purpose of the study is to evaluate whether insulin treatment during pulmonary     exacerbation (PE) in patients with Cystic Fibrosis (CF)and normoglycemia improves their short     term outcome by normalizing the glycemic profile and enhancing recovery. the investigators     would like to evaluate whether insulin treatment during exacerbation improves both the     general clinical condition of these patients and also has a protecting effect on ß-cells by     preventing the deleterious effect of chronic hyperglycemia.   "
251568|NCT01149018|"     The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in     patients suffering from Fibromyalgia   "
251569|NCT01149031|"     Provoked vestibulodynia, previously called vulvar vestibulitis syndrome, is clinically     defined as chronic, unexplained, vulvar pain or discomfort confined to the vulvar vestibule     in response to contact or pressure. In addition, many patients also have pain in response to     non-sexual activities such as tampon insertion, gynecological examinations or physical     pursuits such as bicycle riding; the severity of other vulvo-vaginal symptoms such as     itching, burning and irritation varies. Once women with provoked vestibulodynia develop the     syndrome, symptoms may last for months or years; as a result, provoked vestibulodynia has a     profound effect on women's sexuality and psychological well-being. The diagnosis of provoked     vestibulodynia is usually made by ascertaining if the patient fulfills modified Friedrich's     criteria, consisting of 1) a history of vulvar pain, dyspareunia or pain with tampon     insertion, 2) tenderness of the vestibule when being touched with a cotton-tip applicator and     3) no identifiable cause for the pain.      The etiology of this condition remains unknown. Proposed causes include chronic inflammation,     peripheral neuropathy, genetic, immunologic and hormonal factors, infectious, psychological     disorders, sexual dysfunction or disturbance in the central nervous system. Because the cause     of provoked vestibulodynia remains unknown, many different treatments have been described for     this condition, including topical and intra-lesional corticosteroids, topical anesthetics     such as lidocaine, topical estrogen, topical or oral antidepressants or anti-convulsants,     biofeedback or physical therapy, surgical resection of the involved tissue (vestibulectomy)     and a variety of complementary and alternative therapies.      Low level laser therapy (LLLT) is an emerging medical technique in which exposure to     low-level laser light or light emitting diodes might stimulate or inhibit cellular function,     possibly leading to beneficial clinical effects. Clinical applications that show some     potential of effectiveness include treating soft tissue injury, chronic pain, and wound     healing. The usage of low level laser therapy was found effective in various pain syndromes,     and has no side effects.      Since inflammatory mechanisms have been proposed in the pathogenesis of provoked     vestibulodynia, and as there is no effective therapy for this syndrome, the investigators     intend to study whether low level laser therapy might be an effective therapy for provoked     vestibulodynia.   "
251570|NCT01149044|"     This is an international, randomized, controlled, parallel group study in which patients with     ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following:     Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.   "
251571|NCT01149057|"     This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra     (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an     inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs     (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4     weeks. Anticipated time on study treatment is 96 weeks.   "
251572|NCT01149070|"     Human gonadotrophins have been successfully used for the treatment of infertility for more     than 30 years. This observational study is being conducted to evaluate the efficacy and     safety of the gonadotropins used for controlled ovarian stimulation (COS) in assisted     reproductive technologies (ART).   "
251573|NCT01149083|"     This phase II trial studies how well veliparib with or without carboplatin works in treating     patients with stage III-IV breast cancer. Veliparib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. It is not yet     known whether veliparib is more effective with or without carboplatin in treating breast     cancer.   "
251574|NCT01149096|"     This randomized clinical trial is studying the side effects of collection of bone marrow from     donors treated with or without filgrastim. Giving colony-stimulating factors, such as     filgrastim (G-CSF), to donors helps the stem cells move from the bone marrow to the blood so     they can be collected and stored.   "
251575|NCT01149109|"     The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent     therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60     Gy), the median overall survival time (mOS) is 14.6 months (Stupp et al., 2005). Since in a     previous non-randomized bicentric phase II trial, primary combination chemotherapy with     lomustine (CCNU) and TMZ was highly effective (mOS 23 months; UKT-03 trial; Herrlinger et     al., 2006; Glas et al., 2009) the proposed trial further investigates the efficacy of     CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the     projected phase III trial confirms the phase II data, CCNU/TMZ combination would be     significantly better than TMZ monotherapy and would thus be the new standard treatment for     newly diagnosed GBM patients with a methylated MGMT promotor. Thus, this trial has the     potential to profoundly change the standard therapy of this most aggressive brain tumor.     Since in the previous trial only patients with a methylated MGMT (mMGMT) promoter had a     benefit from CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12.5 months;     Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the     trial is restricted to mMGMT patients.The CeTeG trial randomizes in a 1:1 fashion newly     diagnosed GBM patients (18-70 years) for either standard TMZ therapy (concomitant and 6     courses à 4 weeks of adjuvant TMZ therapy) or experimental CCNU/TMZ therapy (6 courses à 6     weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming     that CCNU/TMZ therapy increases the median overall survival (mOS) from 48.9% (standard TMZ)     to 70% (CCNU/TMZ; 75% in the previous phase II trial, Glas et al., 2009), 2 x 68 patients     have to be accrued. Patients will be accrued over 24 months and each patient will be followed     for at least 24 months adding up to a total minimal duration of the time from first patient     in until the end of the follow-up time of 48 months. The primary endpoint is overall     survival; secondary endpoints include progression-free survival, response rate, acute and     late toxicity, and quality of life.   "
252111|NCT01157078|"     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like     medicine tablet or capsule, but contains no active medicine) is safe and effective when taken     together with another antidepressant.   "
251577|NCT01149135|"     One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal     Affective Disorder(SAD) or so called winter depression is a disturbance of circadian rhythms.     Since the circadian system is especially sensitive for the blue portion of the light     spectrum, a new light therapy device with more blue light (blue enriched polychromatic light)     was tested for its efficacy to treat SAD. In chronobiological terms this light is     hypothesized to be more potent in inducing non-visual effects. In the present study     fluorescent tubes that emit a high portion of short wavelength light on top of the normal     wavelengths are tested for its superiority in treating SAD. This blue-enriched light (colour     temperature 17000 ºK) is compared to standard light treatment (5000 º K) in SAD patients.,In     a earlier study it was shown that the therapeutic effect of blue enriched light were equal to     standard light treatment using light in both conditions with an intensity of 10 000 lux. In     the present study, blue enriched light with an intensity of 750 lux was used, because of the     possible saturation effect in the former study. The investigators hypothesise that blue-     enriched light with a low intensity improve the therapeutic effects of light treatment     leading to a higher response or the same response in a shorter time schedule compared to     standard light treatment.   "
251578|NCT01149148|"     The investigators hypothesize that early intervention to optimize regional cerebral     oxygenation detected by cerebral oximetry monitoring during deep hypothermic circulatory     arrest (DHCA) for patients undergoing aortic surgery will decrease the incidence of transient     and permanent neurological dysfunction and improve neurocognitive impairment.   "
251579|NCT01149161|"     Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role     of lymph node dissection in the treatment of microPTC remains controversial. The     investigators want to investigate the usefulness routine central dissection and sentinel     lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study.     The investigators started this study from May of 2009 and this study will be continued until     Dec. 2011.   "
251580|NCT01149174|"     Early single instillation of chemotherapy after TUR is recommended in the European     Association of Urology Guidelines. Nevertheless, the procedure is suboptimal for patients     with multiple tumors, sometimes is not tolerated and it can results in severe complications.     In both laboratory and clinical studies, intravesical electromotive drug administration     (EMDA) increases mitomycin-C (MMC) bladder uptake, resulting in an improved clinical efficacy     in non-muscle invasive bladder cancer (NMIBC). The investigators will compare the effects of     one immediate pre-TUR intravesical EMDA/MMC instillation with one immediate post-TUR     intravesical passive diffusion MMC (PD/MMC) instillation and TUR alone in patients with     NMIBC.      All eligible patients with primary NMIBC will be randomized into 3 groups who will undergo     transurethral resection alone (TUR/alone); TUR plus single immediate postoperative     instillation (immediately after TUR) of 40 mg PD/MMC with a dwell time of 60 minutes; or     single immediate preoperative instillation (immediately before TUR) of 40 mg EMDA/MMC with 20     mA electric current for 30 minutes. Patients with intermediate and high risk NMIBC will     undergo adjuvant intravesical therapy. The primary end points will be the recurrence rate and     disease-free interval. All clinical analyses will be performed on an intent to treat basis.   "
251581|NCT01149187|"     Among the causes of the solitary pulmonary nodule (SPN), benign causes including tuberculosis     was noted on 15 to 60 percents in various studies.      Although the characteristics of chest imaging is helpful in diagnosis and percutaneous needle     biopsy for pulmonary nodule has been represented high diagnostic yield in many reports, but     still surgical biopsy has been needed in definite diagnosis of pulmonary nodules in many     cases.      The aim of this study is to evaluate the usefulness of interferon-gamma release assay in     addition to the percutaneous needle biopsy, in diagnosis of pulmonary nodules.   "
251582|NCT01149200|"     Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant     IBS patients over a 28-day period.   "
251583|NCT01149213|"     The investigators purpose is to follow remitted patients from their previous study using     transcranial direct current stimulation (tDCS); as to verify whether this treatment prevents     relapse.   "
251584|NCT01149226|"     Effects of Choral Hydrate on Induction, Maintenance, and Recovery from Sevoflurane Anesthesia     in Day-case Pediatric Surgery   "
251585|NCT01149239|"     This study is to evaluate the level of anxiety, and to check the correlation of induction     dose and the amount of sevoflurane to keep anesthetic depth in in female patients undergoing     thyroidectomy.   "
251586|NCT01149252|"     The purpose of this study is to determine the safety and efficacy of a new product,     Psoralait, as compared to a placebo in the treatment of psoriasis.   "
251587|NCT01149265|"     The purpose of this study is to determine the effectiveness of online support groups for     anxiety and depression.   "
251588|NCT01149278|"     The ideal mean arterial pressure in patients with septic shock is unknown. The expert's     recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis     are weak. Indead there are only few prospective studies which addressed this question without     clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two     levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)   "
251589|NCT01149291|"     The aim of this post-marketing observational study is to obtain further data on the long term     use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in     the normal clinical setting and according to the approved Summary of Product Characteristics     for the treatment of secondary hyperparathyroidism in hemodialysis patients in Turkey. The     relation of the safety data to PTH (Parathyroid hormone) suppression over time will be     evaluated. Also the number and incidence of hypercalcemia and hyperphosphatemia will be     recorded.   "
251590|NCT01149304|"     To evaluate whether a combination regimen of pentoxifylline, ursodeoxycholic acid and     enoxaparin provides a protective effect on the liver parenchyma after high dose rate (HDR)     brachytherapy.   "
251646|NCT01143688|"     The investigators hypothesize that different placebos will have different effects on     subjective and objective asthma outcomes compared with actual therapy and natural history. .      Subjects with asthma are randomly treated with placebo inhaler, placebo acupuncture,     albuterol inhaler, or no treatment in random order, on three different occasions each. At     each of the 12 visits, spirometry is performed repeatedly over 2 hours. Maximum FEV1 achieved     and an 11-point, self-reported scale of improvement are examined.   "
251591|NCT01149317|"     Chronic pain is a significant public health problem, associated with impairments of physical     and psychological functioning. While a third or more of the general population may suffer     from chronic pain, it is often under recognized and under treated in health care settings.     Low income and minority samples experience disparities in the prevalence of chronic pain, in     perceived access to effective pain treatment, and in consultations for pain. A great deal of     literature suggests that acupuncture offers potential benefit in the management of chronic     pain, but it is rarely available to low income patients. The Acupuncture to Decrease     Disparities in Outcomes of Pain Treatment (ADDOPT) project will introduce and evaluate the     addition of acupuncture to the management of chronic pain for ethnically diverse, low-income     primary care patients. The project represents a collaboration between the New York City     Research and Improvement Networking Group (NYC RING), a practice-based research network     dedicated to decreasing health disparities through primary care research, the Continuum     Center for Health and Healing,The Swedish Institute School of Acupuncture, and Pacific     College of Oriental Medicine. Our intervention will involve addition of weekly acupuncture     sessions at 3 urban primary care practices. During training sessions at each practice,     primary care providers will become familiar with acupuncture and indications for referral.     Patients will be eligible if they experience chronic pain due to neck pain, back pain, or     osteoarthritis. Our process evaluation, guided by Glasgow's REAIM framework, will assess     barriers to implementation and adoption of the intervention in busy urban practices and     acceptability to patients and providers. The investigators will employ a quasiexperimental     design to assess primary outcomes (pain and quality of life) and obtain preliminary estimates     of secondary outcomes (health care utilization and costs) of the intervention at each health     center. This design will permit comparison across sites to discern practice level differences     in uptake and outcomes.   "
251592|NCT01149330|"     The purpose of this study is to demonstrate the efficacy of Adapalene 0.1%/Benzoyl Peroxide     2.5% Gel in the treatment of acne vulgaris. The safety will also be evaluated.   "
251593|NCT01149343|"     The purpose of this clinical study is to examine the safety, immunogenicity and clinical     activity of the immunotherapeutic product GSK2302025A (also referred to as recPRAME + AS15     Antigen-Specific Cancer Immunotherapeutic [ASCI]) administered as a first line treatment in     patients with unresectable and progressive metastatic cutaneous melanoma.   "
251594|NCT01149356|"     This partially randomized phase I trial is studying the side effects and the best dose of     RO4929097 when given together with exemestane and to see how well it works compared to     exemestane alone in treating premenopausal and postmenopausal patients with advanced or     metastatic breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone     therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body     makes. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Giving exemestane together with RO4929097 may kill more breast cancer cells.   "
251595|NCT01149369|"     The principal objective of this multicenter, randomized, placebo-controlled trial is to     evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with     placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.   "
251596|NCT01149382|"     Influenza virus is an important cause of morbidity in the transplant population and can lead     to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for     organ transplant patients, studies have shown that the standard inactivated influenza vaccine     has poor immunogenicity in this population. The investigators plan to test the humoral     response to vaccination and look at HLA upregulation   "
251597|NCT01149395|"     The purpose of this research study is to determine in heartburn patients with nonerosive     disease if detecting the presence of a fragment of the protein e-cadherin in esophageal     epithelium or the amount of fragments of e-cadherin in blood can be used to monitor healing     of esophagitis treated with a proton pump inhibitor (PPI). The hypothesis is that the     presence of fragments of e-cadherin in esophageal epithelium or the amount of fragments of     e-cadherin in blood can you useful as a biomarker for the healing of esophagitis in patients     successfully treated with a PPI.   "
251598|NCT01149408|"     The study aims at determining the feasibility of using maintenance Decitabine therapy     following remission induction and consolidation in elderly Acute Myeloid Leukemia patients     who are fit for aggressive therapy.      Primary: Safety and tolerability of the decitabine regimen in the post remission state.      Secondary:        1. Disease-free survival - To determine the one-year disease-free survival in elderly          patients with acute myeloid leukemia (AML) in complete remission treated with Decitabine          as post-consolidation maintenance therapy.        2. Overall survival   "
251599|NCT01149421|"     The purpose of this study is to assess the effects of 2 doses of LY2189265 on blood pressure     and heart rate using 24-hour ambulatory blood pressure monitoring (ABPM), in participants     with type 2 diabetes mellitus treated with oral antihyperglycemic medications (OAMs).   "
251600|NCT01149434|"     The study consists of two parts: Drug Interaction (Pharmacokinetic) Phase and Pharmacodynamic     Phase      The primary study objective for the Drug Interaction Study is to determine the     pharmacokinetic interactions between RAD001 and JI-101.      The primary study objective for the Pharmacodynamic Study is progression-free survival at 2     moths, evaluated separately in each of the three cohorts.      These will include a determination of tumor response using Response Evaluation Criteria in     Solid Tumors (RECIST) Criteria and an assessment of ephrinB4 expression in blood samples.      Secondary objectives are to determine safety and tolerability of JI-101. The investigational     products are everolimus (42-O-(2-hydroxyethyl) rapamycin) and JI-101     (1-[1-(2-amino-pyridin-4-ylmethyl)-1H-indol-4-yl]-3-(5-bromo-2 methoxy-phenyl)-urea)      Eligible patients meeting all study entry criteria will be enrolled in the study. For the     Drug Interaction study, patients with solid tumors will receive a single dose (10 mg) of     Everolimus by mouth on Day 1 and Day 8 and JI-101 capsules (200 mg) by mouth on Day 8 and Day     15. For the Pharmacodynamic Study, all patients will receive JI-101 capsules by mouth (200 mg     BID) for 28 day treatment cycles.   "
251623|NCT01143376|"     The most appropriate and effective exercise interventions for weight loss remain a matter of     continued discussion and there is a need to identify sustainable exercise programs which     successfully promote weight loss and benefit health.      The primary objective of this study is to determine if high-intensity intermittent sprinting     (HIIS) produces better results in terms of reducing metabolic and cardiovascular risk     factors, with special emphasis to fat mass loss and insulin sensitivity in healthy obese     volunteers compared with an iso-caloric program of moderate-intensity continuous cycling     (MICC) (control condition following the international recommendations). We will also assess     the impact of short duration sprints (SDS) in the above factors and to understand the     potential mechanisms behind different outcomes among training programs.      The overall hypothesis is that HIIS will lead to a greater reduction in metabolic and     cardiovascular risk factors compared with MICC in healthy obese volunteers and that SDS will     produce similar improvements in cardiovascular risk factors as the longer duration HIIS   "
251601|NCT01149447|"     Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous     closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is     secondary to a paradoxical embolism. After the PFO closure procedure a dual antiplatelet     regimen is often prescribed for 3-6 months and several cardiologic and neurologic follow-up     exams are scheduled in the first 12 months of follow-up. Usually a transthoracic +/-     transoesophageal echocardiography (TTE +/- TEE) are performed at 6 months, however this kind     of control is not systematically performed. In order to improve the clinical outcomes in this     young patients' population, the investigators prospectively perform a complete cardiologic     and neurologic follow-up program to all patients undergoing a successful percutaneous closure     of a PFO.      The aim of these controls is to confirm the good position of the PFO-device, to confirm the     absence of any residual right to left shunt or any significant atrial arrhythmias Furthermore     this prospective follow-up will analyze the possible mechanisms leading to a cerebral stroke     recurrence (e.g. size of the PFO, presence of an atrial septal aneurysm, presence of a     residual shunt, size of the utilized closure device, ....).   "
251602|NCT01149460|"     The objective of this study was to compare the rate and extent of absorption of Teva     Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir,     administered as 1 x 1000 mg tablet under fed conditions.   "
251603|NCT01149473|"     The objective of this study is to compare the relative bioavailability of Losartan     potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical     Industries, Ltd. and distributed by Teva Pharmaceuticals USA) with that of Hyzaar® 100/25 mg     tablets (Merck) in healthy, adult, non-smoking subjects under non-fasting conditions.   "
251604|NCT01149486|"     The object of this study was to compare the relative bioavailability (rate and extent of     absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva     Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of     Hyzaar® 100/25 mg Tablets distributed by Merck & Co., Inc. following a single oral dose (1 x     100/25 mg tablet) in healthy adult subjects administered under fasting conditions.   "
251605|NCT01149499|"     The objective of this study is to compare the rate and extent of absorption of valacyclovir     1000 mg tablet (test) versus Valtrex (reference), administered as 1 x 1000 mg tablet under     fasting conditions.   "
251606|NCT01149512|"     The majority of data documenting the outcomes for the adjustable gastric band (LAGB)     originate from non-publicly funded surgical centres. The investigators aim to investigate the     clinical outcomes of LAGB from a publicly funded Canadian obesity management program. This     program recognized obesity as a chronic disease, providing extensive pre-operative     multidisciplinary assessment and long term patient follow-up. Patients are selected for     surgical management carefully by a multidisciplinary team and the LAGB is presented as one     option to surgical management. Further, the investigators will investigate the operational     impacts, including direct and indirect costs related the LAGB, to determine long term impacts     on publicly funded hospitals within Canada.   "
251607|NCT01149525|"     The objective of this study is to evaluate the efficacy of L-carnitine versus placebo in the     treatment of fatigue in multiple sclerosis patients. This study will randomize 60 patients in     a cross-over design. This study is sponsored by academic French health institutions.   "
251608|NCT01149538|"     The purpose of this study is to determine if choline bitartrate can be administered daily to     children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain     development and cognitive functioning.   "
251609|NCT01149551|"     The purpose of this study is to detect genetic associations for the development of     schizophrenia (SZ) and bipolar illness (BP) by comparing Veterans with these diseases to     psychiatrically healthy Veterans from Veterans Health Administration medical centers. In     addition, the genetic basis for functional capacity and disability in Veterans affected with     SZ and BP will be assessed, as will genetic predictors of suicidality and tardive dyskinesia.     Finally, we will also establish a repository which allows for future genomic studies related     to SZ, BP, and related disorders or sequelae.   "
251610|NCT01149564|"     Background:      Patent ductus arteriosus (PDA) continues to be one of the most common problems in premature     infants. Pharmacological closure of PDA with intravenous (IV) indomethacin was first reported     in 1976, however, concern remains regarding the safety of indomethacin, which affects renal,     GI and cerebral perfusion and may lead to complications such as transient or permanent renal     dysfunction, NEC, GI hemorrhage, and reduced cerebral oxygenation. Recently, IV ibuprofen has     been shown to be effective for the closure of patent ductus arteriosus in premature infants,     without reducing mesenteric, renal, or cerebral blood flow. We have developed the     echocardiographic PDA flow pattern as a guide for PDA treatment, fewer doses of drugs were     needed to achieve acceptable closing rates. We have also reported that IV ibuprofen is as     effective as IV indometacin for the PDA treatment in extremely premature infants, without     increasing the incidence of complications in a randomised controlled trial. Several studies     reported that oral ibuprofen may be effective for PDA treatment. To date there is no firm     conclusion as to the efficacy and safety of oral ibuprofen compared with IV ibuprofen for PDA     closure in extremely premature infants.      Objective:      Since the efficacy of pharmacological closure of PDA is related to gestational age, and     extremely premature infants carry the highest rate of mortality and morbidity. We intend to     conduct a randomized controlled trial to compare oral and intravenous ibuprofen for treatment     of PDA in this high-risk population of extremely premature infants.      Methods:      Extremely premature infants (gestational age < 28 weeks) admit to the NICU will be eligible     for enrollment. Informed parental consent will be obtained according to the Institutional     Review Board's instructions. Extremely premature infants with respiratory distress syndrome     (RDS) and PDA confirmed by echocardiography will be randomly assigned to receive either oral     or IV ibuprofen. The subsequent doses of ibuprofen are also determined according to our     specific echocardiographic PDA flow patterns at intervals of once every 24 hours from the     last dose. The dosage of oral or ibuprofen is 10 mg/kg (1 ml) and then 5 mg/kg at 24-hour     intervals as indicated by echocardiographic PDA flow pattern.      Sample Size Calculation and Length of the Study Period:      About 50-60 extremely premature infants will be admitted to our NICU each year. To prove with     McNemar's Test at a one-sided significance level of 5% and a power of 90% that using oral     ibuprofen instead of IV ibuprofen results in comparable PDA closure rates, only 31 extremely     premature infants with RDS and PDA have to be enrolled. Allowing for attrition and exclusion     from the final study groups, the length of the study period will be safe to set to 2 years.      Expected Results:      We expect to determine whether oral ibuprofen is effective and safe in inducing PDA closure     in extremely premature infants and to compare the complications between infants treated with     oral ibuprofen and those with IV ibuprofen.   "
251611|NCT01149577|"     Acute and sub-chronic administration of olanzapine has shown a favourable effect on the sleep     disturbances in previously medicated schizophrenia patients with predominantly negative     symptoms. The present study will be carried out to clarify the effect of olanzapine on     polysomnographic profiles of schizophrenia patients in an acute phase of illness after     controlling for the drug effects.   "
251612|NCT01149590|"     The primary objective of the study is to see if coronary artery calcium score and computed     tomography coronary angiogram alters the proportion of patients diagnosed with angina due to     coronary heart disease.   "
251624|NCT01143389|"     The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light     to treat progressive keratoconus or post-refractive corneal ectasia.   "
251613|NCT01149603|"     Purpose: The purpose of the Destination Therapy Evaluation for Failing Fontan Study (DEFINe     Study) is to perform a single center physician-investigator led feasibility study to initiate     examination of the safety and efficacy of implanting continuous flow circulatory support     devices in 20 patients with failing Fontan physiology, not amenable to other surgical or     medical therapy and who are not candidates for heart transplantation. Based upon the results     of the DEFINe study, consideration would be given to a larger multicenter study. The primary     endpoint is survival without a disabling stroke at two years. Safety, functional status,     total days alive following hospital discharge and quality of life assessments will be     evaluated as secondary endpoints.      Background: Patients born with the congenital anomaly of a single ventricle often undergo     Fontan procedures to improve oxygenation and circulation. As the patient matures, the     benefits of the Fontan procedures become exhausted. These patients present as young adults     with heart failure, and should be considered for heart transplantation. Failed Fontan     physiology patients are now more commonly surviving into their 30s and 40s due to the     advancement in surgical Fontan procedures over the last several decades. Yet, many patients     are not appropriate transplant candidates due to progression of pulmonary failure that     surpasses the pulmonary vascular resistance limits, end organ failure effects to the liver,     and cardiac failure that does not present with left ventricular ejection fractions of less     than 25%. Congenital heart disease is considered a higher risk indication for     transplantation. Such patients present a complex anatomy, scar tissue from prior procedures,     unique pathological states and limited ability to assess hemodynamics.      Methods: Patients with failing Fontan physiology will be evaluated for surgical intervention,     heart transplantation or participation in the study for long-term support, known as     Destination Therapy (DT). Patients who do not meet the study criteria will be asked to     participate in a sub-study to collect patient information. Consenting patients who meet the     study criteria will be implanted with a HeartMate II Ventricular Assist Device (VAD) to     improve cardiac output. Following VAD implantation, the patient will recover in the hospital,     and then discharge to home or an approved facility. Study data will be collected as long as     the patient receives VAD support. Placement of the VAD and continuing patient care should     improve cardiac output and quality of life for this population of patients born with the     congenital anomaly of a single ventricle.      Outcomes: The primary endpoint of the study is to examine survival without a disabling stroke     at two years (defined as a score of four or greater on the Modified Rankin Scale). Safety,     functional status, total-days-alive following hospital discharge, and quality of life     assessments will be evaluated as secondary endpoints.   "
251614|NCT01143259|"     The purpose of this study is to determine if the addition of alvimopan to our care process     model for colon resection patients will decrease length of stay. The care process model is a     combination of optimal IV fluid management, early feeding, early ambulation, patient     education, and pain management.   "
251615|NCT01143272|"     When patients in hospitals receive antibiotics they often develop diarrhoea. The consequences     may be grave for the patient. Thus far, no preventive measure is available. The investigators     hypothesize that the apathogenic yeast Saccharomyces boulardii, administered in addition to     the antibiotic, may prevent episodes of diarrhoea or may lead to less pronounced diarrhoea.     To test this hypothesis, the investigators are carrying out a clinical trial in 1520 adult     patients in several hospitals.   "
251616|NCT01143285|"     Description of active nutritional support: Early and active nutritional support is mainly     concerned with maintaining protein and energy intake levels despite chemotherapy. A part-time     nutritionist will be assigned to each research centre. She will cover active nutritional     support during a one-hour consultation and assist the investigating oncologist in filling out     the e-CRF data. A two-day meeting prior to the beginning of the study will enable the     standardization of active nutritional support strategy across all research centres:        -  The nutritionist will explain the consequences of the side effects of chemotherapy on          appetite levels and nutritional status.        -  Spontaneous oral intake and eating habits will be assessed based on a qualitative and          quantitative 3-day food record.        -  Then the nutritionist will explain to patients how to adapt their diet (fortification,          portion control etc.) according to personal preferences and dietary habits, appetite          fluctuation and side effects.        -  A booklet containing an overview of the nutritional counsel, recipe ideas, an example of          a daily menu, energy equivalence tables and specific diet and hygiene tips for each          possible side effects of chemotherapy will be given to all patients.        -  During each consultation, patients will be weighed, appetite and food intake will be          evaluated (24-hour record except for prospective 3-day record of V0, V3, V6, V9, V12,          V13 and V14 consultations), chemotherapy side effects will be recorded and nutritional          counsel will be adapted to each patient's individual situation. In case of decrease in          food intake and/or weight loss, a protein- and energy-rich oral supplement will be          given.      In both groups, if a patient exhibits signs of malnutrition (weight loss >5% over a one-month     period or > 10% in total) and/or food intake less than 50% of estimated daily requirements,     an oral supplement will be given after approval of the oncologist. If this measure is     insufficient, artificial nutrition (enteral or parenteral) will be considered.   "
251617|NCT01143298|"     The purpose of this phase 1 study is to determine the relative bioavailability following     single oral dose administration of LEO 27847 solution compared to LEO 27847 tablets in     healthy male subjects as well as to determine the effect of food on the single oral dose     pharmacokinetics of LEO 27847 tablets in healthy male subjects.   "
251618|NCT01143311|"     The aim of this study is to analyze the differential expression of the miR transcriptome in     the distinctive stages of the development of cutaneous squamous cell carcinoma (C-SCC). In     this aim the investigators plan to recruit a cohort of 20 patients suffering of C-SCC and to     collect from each of them, biopsies corresponding to i) non UV-exposed areas ii) UV-exposed     areas, iii) actinic keratosis and iv) tumoral regions. Total RNAs will be prepared from each     biopsy and the miRNA profiles will be characterized using a dedicated miR array.   "
251619|NCT01143324|"     The aim of the study is to observe and document surgical practice and evaluate patients'     outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF     (Posterior Lumbar Interbody Fusion) or TLIF (Transforaminal Lumbar Interbody Fusion)     techniques for the treatment of the degenerative lumbar spine in a real-world patient     population.   "
251620|NCT01143337|"     The purpose of this study is to determine the Efficacy, Safety, and Pharmacokinetics of     MP-435 administered for 12 weeks in subjects with rheumatoid arthritis (RA) on stable doses     of Methotrexate.   "
251621|NCT01143350|"     The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium     term effectiveness of staff education as a non-pharmacological intervention to manage apathy     in older people with a diagnosis of dementia.        -  Primary efficacy criteria: Apathy Inventory clinician score changes        -  Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes,          Observation scale changes, frequency and severity of the other BPSD using the NPI,          qualitative analysis of the nursing home staff behavioural changes   "
251622|NCT01143363|"     Several studies have shown that high intensity intermittent sprints (HIIS) are more effective     than moderate intensity continuous cycling (MICC) in reducing fat mass and improving insulin     resistance in normal weight individuals. Changes in the appetite-regulatory system in     response to exercise are likely to explain, at least partially, the better outcome observed     after HIIS. Unfortunately, there are no studies comparing the impact of different types of     acute aerobic exercise on the release of appetite-regulating hormones, subjective feelings of     appetite and subsequent energy intake (EI).      The primary objective of this study is to investigate the effects of acute isocaloric bouts     of HIIT and MICC or a short duration sprint, in comparison with a resting control condition,     on the postprandial release of appetite-regulating hormones, subjective feelings of appetite     and subsequent EI in obese individuals. The investigators hypothesize that an isocaloric     session of HIIS will result in a better short-term appetite control compared with MICC, by     reducing hunger feelings and subsequent food intake more than MICC and by inducing a larger     increase in the release of satiety gut peptides compared with the MICC.   "
251626|NCT01143428|"     Background:      - Primary lateral sclerosis (PLS) is a disorder in which nerve cells in the brain that     control movement degenerate. The cause of PLS is not known, but some research has suggested     that environmental factors that produce oxidative stress trigger PLS in people who carry     certain genes. Oxidative stress is caused when the body makes chemicals called free     radicals faster than its natural systems can break them down. Oxidative stress can be     triggered by exposures to chemicals related to the bodily effects of lead, smoking, alcohol     consumption, physical activity, and psychological stress. Chemicals produced by the body     during oxidative stress can be measured in the blood and urine. Researchers are interested in     studying the physical, neurological, and chemical effects of PLS to better understand the     effects of oxidative stress on the disorder.      Objectives:      - To study the relation of oxidative stress to the diagnosis and progression of motor neuron     disease.      Eligibility:      - Individuals 20 years of age or older who have been diagnosed with PLS, and have had     symptoms of PLS for at least 5 but not more than 8 years and been previously enrolled in     01-N-0145 Screening: Neurologic Disorders with Muscle Stiffness      Design:        -  Participants will have an initial study visit and three follow-up visits. Each visit          will require approximately 3 days of testing at the National Institutes of Health          Clinical Center.        -  As part of this study, participants will have the following tests and procedures:        -  Neurological examination to test muscle strength, sensation, coordination, and reflexes,          as well as clarity of speech        -  Tests of memory, attention, concentration, and thinking        -  Surveys on oxidative stress, including questions on life, mood, jobs held, and habit        -  Electromyography to record the electrical activity of muscles        -  Transcranial magnetic stimulation to measure electrical activity translated from their          brain to the muscles        -  Blood, urine, and skin biopsy samples for testing and sample collection        -  After the initial visit, participants will have three more visits, once each in the          following 3 years.   "
251627|NCT01143441|"     Objective:      The primary goal of this study is to investigate the mechanism of action (MOA) of     CD25-blocking therapies in high inflammatory multiple sclerosis (HI-MS). The secondary goal     of this study is to assess long-term safety and efficacy of CD25-blocking therapies in HI-MS.      Study population:      Two cohorts of patients will be enrolled:        -  Long-term daclizumab therapy cohort: Up to 15 daclizumab-treated patients with          relapsing-remitting (RR-MS) or secondary-progressive MS (SP-MS) previously classified as          HI-MS based on MRI/clinical criteria, who have been treated with IV daclizumab for a          minimum of 1 year and responded to this therapy with significant (>70%) decrease in          contrast-enhancing lesions (CEL) or stabilization/improvement of disease activity (>60%          decrease in MS relapses and stable or improved EDSS disability score).        -  New treatment cohort: Up to 15 HI-MS patients (RR- or SP-MS) with inadequate therapeutic          response to first-line, FDA-approved immunomodulatory therapies for MS or who cannot,          for any reason, be treated with first-line, FDA-approved immunomodulatory therapies for          MS.      Design:      This is an open label, Phase I trial of 150 mg of daclizumab high yield process (DAC HYP)     administered subcutaneously (SC) every 4 weeks for a total of 3 years.      Outcome measures:      Because the main goal of this study is to investigate the MOA of CD25-blocking therapies in     MS, the primary outcomes are mechanistic immunological studies performed on clinical samples     (peripheral blood mononuclear cells (PBMC), cerebrospinal fluid (CSF) cells and skin     biopsies) derived from DAC HYP-treated patients. The secondary outcome measure is long-term     safety and tolerability of subcutaneous DAC HYP in HI-MS patients.   "
251628|NCT01143454|"     Background:      - Researchers are interested in studying individuals who have known or suspected metabolic or     genetic diseases that put them at a high risk for heart diseases or diseases of their blood     vessels. To improve the results of the study, both affected and nonaffected individuals will     be asked to provide blood and other samples and will undergo tests to evaluate heart and lung     function. Nonaffected individuals will include relatives of affected individuals and healthy     nonrelated volunteers.      Objectives:      - To study individuals who have or are at risk for cardiovascular diseases, as well as their     unaffected relatives and healthy volunteers.      Eligibility:      - Individuals between 2 and 100 years of age. Participants may be healthy volunteers,     individuals with cardiovascular diseases, or unaffected relatives of individuals with     cardiovascular diseases.      Design:        -  Participants will have some or all of the following tests, as directed by the study          researchers:        -  Photography of the face and full body        -  Body measurements        -  Radiography, including chest or limb x-rays        -  Metabolic stress testing to study heart and muscle function        -  Echocardiography to study heart function        -  Magnetic resonance imaging (MRI) studies, including cardiovascular MRI, angiography, and          contrast MRI, to study heart function and performance        -  Computed tomography (CT) angiogram to obtain images of the heart and lungs        -  Positron emission tomography (PET) imaging to study possible fat infiltration of the          heart        -  Six-minute walk test to study heart, lung, and muscle function and performance        -  Vascular ultrasound to study blood vessel walls        -  Blood, tissue, and other specimens will be collected for research and testing, and will          be taken either as part of the clinical study or during surgical procedures.        -  Follow-up studies may be performed under separate research protocols.   "
251629|NCT01143467|"     Background:      - Fatigue is a very common early and late side effect of cancer treatment, including     radiation therapy. The cause of fatigue is poorly understood, making it hard to diagnose and     treat. More research is necessary to understand why patients receiving cancer treatment     experience fatigue. Changes in mitochondria, parts of body cells that help provide energy to     the cell, may contribute to fatigue. Researchers are interested in looking at blood chemicals     and mitochondrial genes of cancer patients to study those associated with fatigue.      Objectives:      - To study the relationship between fatigue and the effects of cancer treatment.      Eligibility:        -  Men at least 18 years of age who have been diagnosed with localized prostate cancer and          are scheduled to receive external beam radiation therapy.        -  Participants on study 09-NR-0088, Molecular-Genetic Correlates of Fatigue in Cancer          Patients Receiving External Beam Radiation Therapy, are also eligible.      Design:        -  This study requires three outpatient visits to the NIH Clinical Center.        -  Participants will be seen before they start radiation treatment, at the middle of          treatment, and at the end of treatment. Each visit will take less than 30 minutes to          complete.        -  Participants will complete questionnaires that ask about fatigue and depression.        -  Participants will provide blood samples for research testing and potential HIV testing.        -  No treatment will be provided as part of this protocol.   "
251644|NCT01143662|"     This study is a multi-center, randomized, open-label and positive controlled Phase II     Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3     dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B     characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed     to establish a dose response and safety relationship sufficient to allow the subsequent     design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon     alfa-2b in hepatitis B patients to satisfy regulatory requirements.   "
251666|NCT01143948|"     Liver disease is an important cause of death in type 2 diabetes. In the population-based     Verona Diabetes Study cirrhosis was the fourth leading cause of death and accounted for 4.4%     of diabetes-related deaths. In another prospective cohort study , cirrhosis accounted for     12.5% of deaths in patients with diabetes. In Egypt hepatitis C virus the commonest of     cirrhosis here has a prevalence of 9.8% in the population with the greatest burden over     national health care bills. Patients with cirrhosis & type 2 diabetes mellitus are always     showing up in all hospital wards without a clear consensus of best management of their     hyperglycemia.   "
251630|NCT01143480|"     Background:      - Innate immunity is the process by which white blood cells and other parts of the immune     system sense and respond to potential infections by causing an inflammation. Researchers are     interested in studying how the body responds to certain environmental factors, and whether     the body s response can contribute to chronic illnesses or diseases such as asthma and     certain types of cancers.      Objectives:      - To examine how specific genes and proteins in blood cells respond to environmental     exposures.      Eligibility:      - Healthy volunteers between 18 and 45 years of age.      Design:        -  The study will involve one visit of 45 to 60 minutes.        -  Participants will be screened with a brief physical examination and finger stick to          determine if they are eligible to donate blood for the study, and will complete a          questionnaire about any medications or other drugs (e.g., cigarettes) they may be          taking.        -  Participants will provide a blood sample for research purposes.   "
251631|NCT01143493|"     Background:      - Glucocorticoids are primary stress response hormones released from the adrenal gland when     an individual is under stress. Chronic or ongoing elevation of these hormones due to     prolonged stress or medical treatments can have numerous harmful effects. Researchers are     interested in learning more about how these hormones affect cell growth, development, and     death. To study glucocorticoid hormones, researchers plan to use the medication     dexamethasone, which affects the parts of cells that respond to glucocorticoid hormones.      Objectives:      - To study glucocorticoid stress hormones in healthy individuals before and after receiving     dexamethasone.      Eligibility:        -  Healthy individuals at least 18 years of age.        -  Participants must not be using certain medications that may affect the dexamethasone          test, including hormonal contraception, steroid-based drugs, and some antidepressants.      Design:        -  This study will require an initial screening visit and a second study visit. The visits          are estimated to require about 1 to 2 hours of participation over a period of up to 14          days.        -  Participants will be screened at visit 1 with a full physical examination and medical          history, and an initial blood sample for testing.        -  For visit 2, participants will be asked to abstain from all food and drinks except for          water for 12 hours before the appointment, and will take one tablet of dexamethasone 9          hours before the appointment.        -  Participants will have a second blood sample taken during visit 2, and will receive a          snack after the blood is drawn.   "
251632|NCT01143506|"     Background:      - The experience of volition that accompanies voluntary movement can be divided into the     sense of will, or deciding to move, and the sense of agency, or feeling that the movement     just made was self-generated. Very little is known regarding the neurological origin of this     sense of volition. Previous research has shown that a particular part of the brain, the     parietal lobe, is involved in our inner sense that we control the movements we make.     Researchers are interested in determining if this sense relies on sensory information from     moving fingers reaching the parietal lobe.      Objectives:      - To determine the brain regions responsible for the sense of volition and the associated     sense of agency.      Eligibility:      - Healthy right-handed individuals between 18 and 55 years of age.      Design:        -  The study will involve a screening visit and two testing visits. The screening visit          will last 30 minutes to 1 hour, and the testing visits will each last 3 to 4 hours.        -  Participants will be screened with a physical examination and medical history.        -  At each testing visit, participants will have a brain magnetic resonance imaging (MRI)          scan, electroencephalography (EEG), and electromyography (EMG). The MRI scan and EEG          will be done during a movement task that involves the thumb, second finger, and fifth          finger of one hand. EMG will be used to monitor movements and muscle activity.        -  During the second testing visit, participants will receive a nerve block using          anesthetic, followed by the MRI, EEG, EMG and movement task. The nerve block will          temporarily numb and prevent the movement of parts of the hand and fingers.        -  After the MRI scan and EEG recording, participants will be asked to rate how much          control they felt they had over choosing whether to move, and how much control they felt          they had in actually making the movements.   "
251633|NCT01143519|"     Background:      - Research has shown that certain proteins in cells may be linked to higher risks of     developing inflammations, tumors, and other medical problems. By examining how the blood     cells of healthy volunteers respond to environmental exposures, researchers hope to better     understand the relationship of genes, environmental factors, and human diseases.      Objectives:      - To examine how specific genes and proteins in blood cells respond to environmental     exposures.      Eligibility:      - Healthy volunteers between 18 and 45 years of age.      Design:        -  The study will involve one visit of 45 to 60 minutes.        -  Participants will be screened with a brief physical examination and finger stick to          determine if they are eligible to donate blood for the study, and will complete a          questionnaire about any medications or other drugs (e.g., cigarettes) they may be          taking.        -  Participants will provide a blood sample for research purposes.   "
251634|NCT01143532|"     Background:      - Genetic variation in a particular chromosome is a major contributor to the increased risk     for kidney disease that is common in people of African descent, although the specific gene,     mutations, and other aspects of the variations remain to be determined. By studying the     outcomes of kidney transplant in donors and recipients of African descent, researchers hope     to better understand the effects of this genetic variation on the success of kidney     transplants.      Objectives:      - To examine possible connections between genetic variations and kidney transplant outcomes     for donors and recipients.      Eligibility:        -  <TAB>Participants in kidney transplant where both donor and recipient were of black          African descent.        -  <TAB>Eligible transplants include both living donor and deceased donor.      Design:        -  The study will involve one visit of up to 8 hours.        -  All participants will provide a detailed personal and family medical history.        -  All participants will provide blood and urine samples, including a 24-hour urine          collection, to test kidney function and collect material for genetic testing.        -  Donor participants will also have a magnetic resonance imaging (MRI) scan of their          remaining kidney.   "
251635|NCT01143545|"     Background:      - Certain types of lung, esophageal, or thymic cancers and mesotheliomas have specific     antigens (protein molecules) on their surfaces. Research studies have shown that giving a     vaccine that contains antigens similar to these may cause an immune response, which may keep     tumors from growing. Researchers are also interested in determining whether the chemotherapy     drug cyclophosphamide and the anti-inflammatory drug celecoxib may help the vaccine work     better, particularly in patients with lung cancer.      Objectives:      - To evaluate the safety and effectiveness of tumor cell vaccines in combination with     cyclophosphamide and celecoxib in patients with cancers involving the chest.      Eligibility:      - Individuals at least 18 years of age who have had surgery for small cell or non-small cell     lung cancer, esophageal cancer, thymoma or thymic carcinoma, and malignant pleural     mesothelioma.      Design:        -  Following recovery from surgery, chemotherapy, or radiation, participants will have          leukapheresis to collect lymphocytes (white blood cells) for testing.        -  Participants will receive celecoxib and cyclophosphamide to take twice a day at home, 7          days before the vaccine.        -  Participants will have the vaccine in the clinical center (one or two shots per month          for 6 months), and will stay in the clinic for about 4 hours after the vaccine.          Participants will keep a diary at home of any side effects from the vaccine, and will          continue to take cyclophosphamide and celecoxib.        -  One month after the sixth vaccine, participants will provide another blood sample for          testing, and if the tests are satisfactory will return to the clinic every 3 months for          2 additional vaccines.        -  Participants will return to clinic for follow-up physical examinations, lab tests, and          scans every 3 months for 2 years and then every 6 months for up to 3 years.   "
251636|NCT01143558|"     Background:      Lyme disease is an infection caused by Borrelia burgdorferi, a bacteria that is transmitted     to humans by ticks. It can cause many different symptoms including rash, fever, headache,     meningitis (infection of the central nervous system), and arthritis. While most patients     improve after taking antibiotics, some patients continue to have symptoms. It is currently     unknown why some patients continue to have symptoms. One possibility is that the antibiotics     have not successfully gotten rid of all of the bacteria. Current tests for Lyme disease     cannot tell whether the bacteria have been successfully eliminated from the body.      Xenodiagnosis is a way to look for Borrelia bacteria using the animal that usually hosts     them, Ixodes scapularis (also known as the deer tick). This method takes advantage of the     evolution of the bacteria and the insect that transmits the infection, which can make the     insect particularly good at finding the agent. In studies of animals, xenodiagnosis may be     more sensitive than current tests for detecting the presence of the Lyme disease bacteria.     Researchers are interested in using xenodiagnosis to determine whether uninfected ticks that     feed on humans who have been infected with Lyme disease bacteria can detect the continued     presence of live bacteria.      Objectives:      - To determine whether xenodiagnosis can be used to successfully investigate the presence of     Lyme disease bacteria.      Eligibility:        1. Individuals at least 18 years of age who are in one of the following categories:        2. Have had the erythema migrans rash (a symptom of Lyme infection) and received antibiotic          therapy less than 4 months ago (but have not had antibiotics in the previous month).        3. Have the erythema migrans rash and received less than 2 days of antibiotic therapy.        4. Have been diagnosed with early or late Lyme disease, have received antibiotic therapy,          but still have high levels of antibodies against the bacteria at least 6 months after          therapy, and have not received antibiotics in the past 3 months.        5. Have been diagnosed with early or late Lyme disease, have received antibiotic therapy,          and have new complaints of fatigue or other symptoms that are persistent for at least 6          months after completion of antibiotic therapy, and have not received antibiotics in the          past 3 months.        6. Have been diagnosed with Lyme arthritis and have not yet received antibiotic therapy.        7. Healthy volunteers who have not had Lyme disease will also be included in this study.      Design:        -  Participants will have an initial visit for a physical examination, medical history, and          blood sample.        -  For the first study visit, researchers will place a strip of filter paper or a small          plastic container with 20 to 30 disease-free ticks on the participant s skin. If          possible, the ticks will be placed at the site of a Lyme disease rash or another          suspicious area, or on the nondominant forearm. Participants will be asked to keep the          ticks in place, and will keep a diary card at home to record any symptoms or problems.        -  The ticks will be collected 4 to 6 days after placement. At that visit, participants          will have a skin biopsy taken of the area tested, a blood sample will be collected, and          participants will receive a new diary card to keep until the next clinic visit.        -  After 1 month, participants will provide a final blood sample, and will receive a          follow-up phone call 2 months afterward.   "
251637|NCT01143571|"     Background:        -  Most studies of infectious agents have focused on specific microbes, such as human          papillomaviruses and cervical cancer, and the hepatitis B and C virus and liver cancer.          The skin and many internal areas (including the mouth and the gastrointestinal tract)          also contain large numbers of naturally occurring microbes, but these areas have not          received as much study.        -  Some of the infectious agents that naturally reside in the body may have an effect on          health. The study of naturally occurring microbes in the human body is a new area of          research, and much remains to be learned regarding the extent and pattern of their          appearance and appropriate techniques for testing them.        -  Researchers are interested in collecting human samples from areas known to contain          naturally occurring microbes. These samples will provide baseline information for          further studies.      Objectives:      - To collect a set of study samples from individuals who have applied to participate in a     study assessing the relationship among the bacteria H. pylori, peptic ulcer disease, and     gastric cancer.      Eligibility:      - Individuals between the ages of 21 and 65 who are participating in the clinical trial     entitled A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter     Pylori.      Design:        -  Researchers will collect oral (saliva), colonic, and skin swab samples from study          participants who tested positive for the presence of the H. pylori bacteria. These          samples will be collected at the three study visits (enrollment, 6 weeks, and 1 year).        -  Researchers will also collect samples from people who applied for the clinical trial but          did not test positive for H. pylori. These samples will be collected at the enrollment          visit and 1 year later.        -  Blood samples will be collected at each study visit.   "
251638|NCT01143584|"     To study the effects of rapid escalation of Cabergoline in comparison to conventional dosing     in macroprolactinomas. Rapid escalation of cabergoline may help in earlier normalization of     prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline     altogether.   "
251639|NCT01143597|"     The long-term goal of this project is to develop rehabilitation strategies that facilitate     optimal restoration of skilled hand use in individuals with spinal cord injury (SCI). The     objective of the studies proposed in this application is to determine whether a protocol of     massed practice + somatosensory stimulation (MP+SS) is more effective for improving skilled     hand use compared to a somatosensory stimulation (SS) alone, and to determine whether these     approaches are each more effective than traditional therapy (consisting of conventional     resistance training; CRT).      Specific Aim I: In individuals with chronic incomplete tetraplegia, quantify changes in     skilled hand use and sensory function associated with either: massed practice training     combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control     (conventional resistance training [CRT]), and compare differences among groups. The     investigators hypothesize that:      H1.1: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor     function (Jebsen-Taylor Hand Function Test and Chedoke-McMaster Arm and Hand Activity     Inventory) and sensory function (quantitative sensory tests; QST) will be greater in     individuals who are trained using MP+SS compared to the SS and RT groups.      H1.2: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor     function and sensory function tests will be greater in individuals who are trained using SS     compared to CRT.      H1.3: At 6 months post training, motor and sensory gains will be retained by the MP+SS and SS     groups.      Specific Aim 2: In individuals with chronic incomplete tetraplegia, quantify changes in     cortical and spinal neurophysiology associated with either: massed practice combined with     somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional     resistance training [CRT]), and compare differences among groups. The investigators     hypothesize that, after 4 weeks:      H2.1: Measures representing cortical neurophysiologic function (i.e., motor-evoked potential     amplitude and location of cortical map) will show greater change in the direction of more     normal values in individuals who are trained using MP+SS compared to the SS and the CRT     groups.      H2.2: Measures representing spinal neurophysiologic function (i.e., F-wave and H-reflex     amplitude) will show greater change in the direction of more normal values in individuals who     are trained using SS compared to the MP+SS and the CRT groups.      H2.3: There will be a positive relationship between change scores associated with functional     outcome measures and cortical neurophysiologic outcome measures in the MP+SS group; there     will be a positive relationship between change scores associated with the functional outcome     measures and spinal neurophysiologic outcome measures in the SS group.      Specific Aim 3: In individuals with chronic incomplete tetraplegia, quantify changes in     self-assessment of quality of life and societal participation associated with massed practice     combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS) or control     (conventional resistance training [CRT]), and compare difference among groups. The     investigators hypothesize that:      H3.1: Gains in scores on standardized measures of quality of life (Medical Outcomes Study     Short Form 36 [SF-36]) and societal participation (Impact on Participation and Autonomy     Questionnaire [IPAQ]) will be greater in individuals who are trained using MP+SS compared to     both the SS and the CRT groups.      H3.2: Gains in scores on standardized measures of quality of life and societal participation     will be greater in individuals who are trained using SS compared to the CRT group.      H3.3: At 6 months post training, gains in the quality of life and the societal participation     measures will be retained by the MP+SS and SS groups.      Risks: This is a low risk study that investigates the effects of standard rehabilitation and     exercise interventions on hand/arm function in individuals with SCI. All devices are     considered minimal risk devices by the FDA.   "
251640|NCT01143610|"     Different surgical techniques have been proposed for root coverage, showing varying results     especially in areas of deep recessions. The aim of this study is to evaluate the     effectiveness of the newly forming bone technique (NFB)as an alternative treatment for Miller     class I or II deep recessions, requiring regeneration of lost periodontal tissues. Sample     should be comprised of patients aged 18-45 years, both genders, presenting at least one site     with marginal tissue recession >4mm. Patients will be randomly assigned to either one of the     groups, based on treatment technique: newly forming bone (NFB) or subepithelial connective     tissue graft (SCTG). Clinical examinations will be performed by a single blinded examiner at     baseline, 1, 3, 6 and 9 months after surgery. Intra-group analysis will be performed by one     way analysis of variance for repeated measures. Inter-group analysis will be performed by     unpaired t-test for each of evaluation periods.   "
251641|NCT01143623|"     The purpose of this study is to determine the dose response effect of probiotic capsules for     the prevention of antibiotic-associated diarrhea (AAD).   "
251642|NCT01143636|"     The purpose of this study is to determine whether transcranial direct current stimulation     (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is     that tDCS will decrease pain significantly when compared to sham stimulation.   "
251643|NCT01143649|"     The purpose of this study is to determine whether noninvasive brain stimulation associated     with motor learning offers an additional benefit than motor learning alone in patients with     stroke.      The investigators hypothesis is that active transcranial direct current stimulation (tDCS)     combined with constraint induced movement therapy (CIMT) will induce a greater motor function     improvement as compared with sham tDCS combined with CIMT.   "
251645|NCT01143675|"     The purpose of this study is to evaluate if poor bone quality increases the risk of specific     types of treatment complications in patients with proximal humerus fractures treated with     open reduction and angle-stable plates (Proximal Humeral Internal Locking System - PHILOS).   "
251647|NCT01143701|"     ADHD is the most prevalent mental health disorder of childhood. The majority of children with     ADHD receive their care in primary care settings. While the American Academy of Pediatrics     (AAP) issued evidence-based guidelines and recommendations for pediatricians, most     pediatricians have difficulty adhering to these guidelines. Given observed deficiencies in     evidence-based ADHD care and the likely effects on child outcomes, the development and     testing of interventions aimed at improving ADHD care in primary care settings is necessary.     Cincinnati Children's Hospital Medical Center has developed a model intervention, termed the     ADHD Collaborative, to comprehensively address this issue. The ADHD Collaborative     intervention model includes academic detailing, quality improvement methods, and innovative     tools (e.g., web portal) designed to promote and support the systematic use of the AAP     guidelines. This intervention model has been used to train over 200 physicians at 55     practices in the Greater Cincinnati area. The intervention appears to produce 2- to 4-fold     increases in the use of evidence-based ADHD-related practice behaviors in participating     physicians. To date, the intervention has been implemented as a quality improvement project     with few experimental controls. The primary goal of the proposed study is to conduct an     experimentally-controlled cluster randomized trial of the ADHD Collaborative intervention.     Thirty-two pediatric practices will be randomly assigned to receive the ADHD Collaborative     intervention or to provide usual care. Approximately 96 physicians and 576 of their ADHD     patients will be included in the study. Chart reviews, parental interviews, and parent and     teacher rating scales will be collected. Between- and within-group hierarchical linear     modeling analyses will examine whether the intervention produces significant improvements in     pediatrician practice behaviors, patient satisfaction with ADHD care, and child outcomes over     and above typical ADHD care. Also, the relative cost effectiveness of the ADHD Collaborative     intervention over typical care will be established by computing incremental     cost-effectiveness ratios using cost and effect size estimates.   "
251648|NCT01143714|"     The purpose of this study is to assess the effect of four weeks of treatment with Santyl     Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic     foot ulcers over four weeks, and on the proportion of subjects achieving complete wound     closure within 12 weeks from initiation of treatment.   "
251649|NCT01143727|"     This study compares two standard methods for cleaning the surface of wounds on the feet of     patients with diabetes mellitus. The question being asked is whether inflammation of the     wound affects the ability of one or both of the methods to work.   "
251650|NCT01143740|"     This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in     patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients     will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per     cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection     may be treated for an additional 3 cycles with RO5045337.   "
251651|NCT01143753|"     This open-label, multi-center study will evaluate the safety, tolerability, and     pharmacokinetics of RO5212054 [PLX3603] in participants with BRAF V600-mutated advanced solid     tumors. Cohorts of participants will receive escalating oral doses of RO5212054. Anticipated     time on study treatment is until disease progression or unacceptable toxicity occurs.   "
251652|NCT01143766|"     The standard approach to sedation in endoscopic retrograde cholangiopancreatography (ERCP)     involves the use of benzodiazepines and opiates to achieve a moderate depth of sedation.     There is data to suggest supplementing this regimen with gabapentin may lead to reduced pain,     higher patient satisfaction and lower opiate requirements. The investigators are conducting a     clinical trial to study this hypothesis.   "
251653|NCT01143779|"     The goal of this clinical research study is to learn if an imaging solution,     [F-18]-fluoro-L-thymidine (FLT), when used with a positron emission tomography (PET) scan,     can help doctors to better see changes in the growth of tumors in the body. Researchers want     to learn if FLT-PET scans can show an early response to chemotherapy.   "
251654|NCT01143792|"     Youth who leave home for the streets are at significantly more risk for a multitude of     problems, yet little research is available to guide treatment intervention efforts with this     population. Studies document high rates of substance use, HIV risk, mental health problems,     teenage pregnancy and criminality. Research to date examining homeless, street living youth     has been primarily descriptive; less effort has been directed towards developing and     evaluating treatment interventions for this group. The majority of homeless youth do not     receive substance abuse treatment, with one study reporting that only 15% of street living     youth report ever receiving mental health services. The effectiveness of the Community     Reinforcement Approach (CRA) with street living youth was studied in our recently completed     Stage 1 trial. The proposed study is a Stage II clinical trial examining outcome of CRA     individual therapy as compared to two interventions commonly employed, yet little researched,     with this group. All clients will be randomized to one of three theoretically distinct     interventions: (1) CRA therapy, (2) Motivational Enhancement Therapy (MET), or (3) Case     Management (CM). The relative effectiveness of these interventions will be evaluated at 3, 6,     and 12 months post-baseline. The Social Ecology Theory of Development (Bronfenbrenner, 1979)     guides our change hypotheses and intervention. Proposed change mechanisms (mediators) for     each intervention will be evaluated. Differential treatment response as a function of     ethnicity, gender, age, sexual orientation and abuse (moderators) will be investigated to     better understand the interventions. The study will also examine how, if at all, treatment     engagement, retention and expectations impact youth response to the three treatments.     Information gained through this project may help address the gap in our understanding of how     best to effectively intervene with a group at high risk for continuing health and     psychological problems.   "
251655|NCT01143805|"     In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate     occasions by two different routes of administration: One time by mouth in tablet form and one     time by vein (intravenous form). The amount of CP-690,550 available in the blood following     administration by vein will be measured and is expected to reflect the maximum amount     possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the     blood following oral tablet administration will also be measured and compared to that     achieved following administration by vein in order to estimate how much of the maximum amount     possible is actually absorbed into the blood following administration by mouth as a tablet.   "
251656|NCT01143818|"     Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men     in the community over 6 months.   "
251657|NCT01143831|"     The purpose of this study is to evaluate factor levels of the pro coagulant factors II, VII,     IX, X, and the anticoagulant factors protein C and S in healthy volunteers during the intake     of elevated levels of vitamin K in order to investigate whether there is any evidence that     high dose vitamin K intake increases plasma coagulation factor activity.   "
251665|NCT01143935|"     Estimation of liver volume is important for live donor liver transplant as well as extended     liver resections. Computed tomography (CT) volumetry which is currently a gold standard for     liver volumetry , is a time consuming process. A quicker method to estimate liver volume is     essential. The aim of the present study is to try and formulate an equation based on patients     height, weight etc to estimate liver volume.   "
251697|NCT01149824|"     In this study, our aim is to determine an active but tolerable sublingual dose (range 100 to     4000 µg) of Salvinorin A (SA) in experienced subjects. This study is an ascending-dose,     placebo-controlled, single-site design in 8 Salvia-experienced subjects. Subjects will     receive SA doses from 0-4000 µg. Doses will be separated by at least one day. The first two     doses (0 and 100µg) will be double-blinded while the last four (250, 500, 1000, 2000 and     4000µg) will be single-blind.   "
251658|NCT01143844|"     Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience     endocrine changes more similar to women in their late reproductive years than to same-age     peers. These changes will be more dramatic in women who receive high dose therapy compared to     women who receive low dose therapy.      At annual visits over 3-5 years, a combination of physical exam, medical history, menstrual     diary keeping, pelvic ultrasound and blood hormones tests will be used to measure ovarian     reserve , that is the number and quality of the eggs that remain in the ovaries. The study     will also try to learn if those who received higher doses of certain chemotherapies are more     likely to have changes in these tests sooner than those women who received smaller doses of     these same drugs. Additionally a DNA (deoxyribonucleic acid) sample will be collected to look     for gene variations that may predict susceptibility to ovarian damage from cancer treatments.     Information learned from this study may help researchers to develop guidelines to identify     problems with a female cancer survivor's ovaries before irregular menses or other symptoms of     ovarian failure occur.   "
251659|NCT01143857|"     Cocaine use, abuse and dependence is a public health problem that is directly responsible for     hundreds of billions of dollars in health care expenditures per year. Relapse rates to     cocaine use are high, creating a pressing need to develop effective therapies for cocaine     dependence. The proposed research will focus on investigating the determinants and     consequences of cocaine dependence via measurement of physiological, behavioral and     subjective effects of acute doses of cocaine in healthy non-drug dependent human volunteers     in the laboratory, and through examination of the effects of pharmacotherapies on the above     effects of cocaine. This study will examine cocaine-derived reinforcement under week-long     sub-chronic varenicline (Chantix) dosing, and under placebo conditions. The study is a     within-subjects crossover design using 24 subjects. Subjects will be screened and consented     into the study at the Treatment Research Center (TRC). Study visits where behavioral and     physiological outcome data will be obtained will be conducted at the Clinical and     Translational Research Center (CTRC) of the Hospital of the University of Pennsylvania.     Subjects will be outpatients for this trial, with CTRC sessions scheduled at least one week     apart.   "
251660|NCT01143870|"     The percent of glycosylated hemoglobin, also known as a hemoglobin A1C value, is the standard     way that clinicians assess a patient's diabetes control. Numerous studies have shown that     maintaining a hemoglobin A1C value less than 7% is associated with lower rates of     diabetes-related complications. Clinicians use this value to determine whether a patient with     diabetes requires changes in their disease management. The main problem with this practice is     that many patients do not understand what this number means. The goal of this project is to     examine ways to make feedback about glycemic control easier for patients to understand. The     hope is that improved patient understanding will result in an improvement in diabetic control     and thus a reduction in disease-associated complications. Patients with a diagnosis of     diabetes and a hemoglobin A1C value greater than 8% within the preceding three months will be     eligible for the study. Pregnant women will be excluded. Given the nature of the intervention     we will also exclude patients with cognitive deficits. In this study, patients will be     randomized to three groups. The first group with be told their HgbA1C value only, the second     group will be told a letter grade interpretation of that value, and the third group will be     shown a face. The face emotions will range from happy to sad reflecting the level of control.     The main outcome will be trend in hemoglobin A1C values over time. Secondary outcomes will     include patient understanding of disease state and the number of hemoglobin A1C values     checked following the intervention.   "
251661|NCT01143883|"     This clinical study is a prospective, randomized, controlled trial of patients undergoing     elective colorectal surgical procedures that receive an abdominal skin incision of at least 6     cm. Treatment with Silverlon® will be compared to standard postoperative dressings of 4x4     Gauze and paper tape. Patients will be randomized with a 1:1 treatment allocation ratio to     receive either 1) Silverlon® or 2) standard postsurgical dressing. Neither the Investigators     nor the participants will be blinded to the treatment modality after randomization.      Silver has long been known to have antimicrobial properties. It interacts with structural     proteins and DNA, inhibiting bacterial replication and causing fatal structural changes     within the cell wall. It has broad antimicrobial activities and unlike antibiotics, it is     rarely associated with microbial resistance. Silverlon® is a silver-nylon dressing     specifically designed for surgical wounds to prevent the development of surgical site     infections. It is an easy to use product with no known microbial resistance or adverse     effects. The efficacy of Silverlon® in preventing surgical site infections has been shown in     several retrospective studies but as of yet has not been tested in a prospective fashion. The     objective of this study is to perform a prospective, randomized, clinical trial directly     comparing the incidence of surgical site infections in patients treated with Silverlon® to     standard postoperative dressing following elective colorectal surgery   "
251662|NCT01143896|"     Chronic infection with hepatitis C (CHC) is a common and expensive condition, and it     disproportionately affects Veterans. Treatment with antiviral therapy reduces liver disease     progression and improves health related quality of life. However, ~70% of Veterans with CHC     are considered ineligible for antiviral treatment. Most of these patients are excluded due to     the presence of co-existing depression and substance use. The proposed project will adapt and     adopt an evidence-based collaborative depression care model in CHC clinics. By removing the     leading contraindication for antiviral treatment, this project will potentially yield     benefits that go far beyond the obvious quality of life benefit from antidepressant therapy     itself.   "
251663|NCT01143909|"     With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically     ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care     (ICU) patients undergoing an invasive procedure. The objective is to assess the effectiveness     and costs of omitting prophylactic FFP transfusion compared to current practice of     prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy.   "
251664|NCT01143922|"     Currently available investigating modalities like CT scans, MRI etc although have a high     accuracy in staging of gastrointestinal(GI) tract malignancies, are not correct in all cases     . The aim of this study is to assess the role of intraoperative ultrasound as a modality to     increase the staging accuracy of GI tract malignancies   "
251667|NCT01143961|"     Surveillance of the lungs for bacteria is routinely undertaken in artificially ventilated     patients as these individuals are at high risk of developing pneumonia. Knowledge of the     types of bacteria present allows the rapid treatment with the correct antibiotics if a     pneumonia develops. Surveillance is undertaken using a technique called non-directed     bronchoalveolar lavage (NBL), which can be performed by the bedside nurse. This involves     suctioning some of the lung secretions into a sample pot and sending it to the microbiology     laboratory to identify any bacteria present. When this procedure is performed there is some     collapse of the lung due to escaping gas. The purpose of this study is:        1. To use a non-invasive imaging technique known as electrical impedance tomography (EIT)          to measure the amount of lung collapse during an NBL. Half of the patients in the study          will have a one-way adapter valve connected to the breathing circuit. This adapter is          designed to make the insertion of a suction catheter easier and prevent the loss of gas.        2. Look at which region of the lung the sample is being collected from as the suction tube          used to take the samples may pass into either the left or right lung.      EIT is a simple non-invasive technique which has been in use for many years. It uses pairs of     electrodes around the chest through which imperceptible currents are passed. A computer shows     an image of which parts of the lungs have the most or least air in them. This has the     advantage over other imaging techniques in critical care that it does not use radiation and     gives a real time picture at the bedside of the variations in ventilation throughout the     lungs.   "
251668|NCT01143974|"     For patients resistant to enthrycycline and taxanes, there is no standard regimen. Pemetrexed     alone had certain efficacy in treatment of advance breast cancer. Platin was also a effective     drug for advanced breast cancer. The combination of these two drug may have a synergy with     each other in treatment of advanced breast cancer.   "
251669|NCT01143987|"     Active parathyroid glands among renal dialysis patients contribute to calcified and hardened     blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms     of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular     calcification. Role of cinacalcet was demonstrated in animal model but human data are     lacking. The investigators designed an open label pilot study to evaluate the effect of     cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary     hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave     velocity at 26 and 52 months after cinacalcet treatment.   "
251670|NCT01144000|"     To determine the outcome and safety of a combined antimicrobial treatment involving     daptomycin and surgical approach involving retention or short-interval two-stage exchange of     the implant. Patients with hip, knee and shoulder Prosthetic Joint Infection (PJI) caused by     methicillin-susceptible and methicillin-resistant staphylococci will be included and followed     during 2 years.   "
251671|NCT01144026|"     This protocol represents the second in human study of TUTI-16, and is being conducted to     continue to gather safety and human immunogenicity (anti-HIV-1 Tat titers) data of     subcutaneously administered TUTI-16.   "
251672|NCT01144039|"     Purpose: The effect of intravenous glutamate infusion on myocardial diastolic function and     overall hemodynamics were studied in patients undergoing elective aortic valve replacement     with severe aortic stenosis and associated left ventricular hypertrophy .      Methods: 25 patients will be included in this double-blind randomized placebo-controlled     study. Glutamate was administered intravenously immediately after aortic cross-clamp release.     The patients receive either a low dose of 30mg kg-1 h-1 (LG-group) or high dose of 60 mg kg-1     h-1 (HG-group) or placebo (P-group) at a rate of 3.3ml kg-1h-1 for 2h. Transesophageal     echocardiography (TEE) is used to measure diastolic and systolic ventricular function before     sternotomy (T0), and 2h (T2), 3h (T3) and 6h (T4) after release of cross clamp. Additionally     routine hemodynamic parameters are measured intraoperatively.   "
251673|NCT01144052|"     Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young     adults. The management of MS-patients requires treatment with disease-modifying agents,     monoclonal antibodies such as natalizumab or immunosuppressants. Natalizumab showed good     efficacy and is approved for treatment of relapsing MS with a number of restrictions due to     safety issues. Cognitive data related to natalizumab treatment are still scarce.     Interferon-beta-1b is approved for high-frequency, subcutaneous (sc) administration in the     treatment of multiple sclerosis. It reduces the relapse rate, severity, hospitalisation and     the disease activity as seen on MRI.      This is a pilot study to explore the concept of de-escalating natalizumab treatment to     interferon-beta-1b e.o.d compared to continuous treatment with natalizumab in patients with     relapsing-remitting multiple sclerosis previously treated with natalizumab for 12 months. The     study is designed as prospective, controlled, randomized, rater-blinded, parallel-group, two     arm, mono-centric including patients of the Ticino Cohort. One arm will be treated with     Interferon-beta 1b 250mcg given subcutaneously every other day, the other with Natalizumab     300 mg given intravenously (i.v.), every four weeks. The treatment duration is 12 months, the     follow-up period 12 months. The time to first on-study relapse will be compared between the     to treatment arms (primary outcome). Other efficacy parameter include clinical and     radiological parameters, patient reported outcome on quality of life and fatigue. Safety is     assessed by reports of adverse events.   "
251674|NCT01144065|"     The purpose of this study is to determine whether hair levels of cortisol and testosterone     are elevated in patients with acute MI compared to controls.   "
251683|NCT01149642|"     This randomised, double-blind study will compare an oral immunomodulatory solution to a     placebo for the prevention of acute severe mucositis in head and neck cancer patients treated     surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of     25% of severe acute mucositis in experimental arm.   "
251698|NCT01149837|"     The InnoLIA HTLV I/II Score is an in vitro diagnostic test for confirmation of antibodies to     human T-cell lymphotropic virus (HTLV) type I and type II in human blood samples. It is     intended as a supplemental test for blood donor samples that are reactive in routine     anti-HTLV screening tests. This study will determine if the test is useful for donor     counseling purposes.   "
252081|NCT01156688|"     The primary objective of this study is to compare the incidence of side effects of buccal and     sublingual misoprostol when combined with mifepristone for medical abortions of less than 9     weeks gestation. The secondary outcome is to compare the complete abortion rate and     induction-abortion interval between the two methods of administration of misoprostol.   "
251675|NCT01144078|"     Body fat is an important risk factors for type 2 diabetes. However, not all body fat is the     same. Research suggests that fat stored in the abdomen is most harmful. This is known as     intra-abdominal fat. The objective of the proposed study is to understand the effect of     exercise intensity on intra-abdominal fat and glucose control. Twenty participants with type     2 diabetes will be assigned to traditional or high intensity exercise. The exercise     interventions will last a total of 14 weeks. Those in the traditional intensity group will     exercise at an intensity comparable to walking. The high intensity group will alternate     between 1 minute at high intensity and 3 minutes at low intensity. Both exercise groups will     burn a similar amount of Calories and will exercise for the same amount of time. The exercise     duration will start at 30 minutes per day. By the end of the study, it will be 60 minutes per     day. All exercise sessions will be supervised. Body fat distribution will be estimated by a     scanning machine called a DXA and anthropometric measures. Glycemic control will be measured     from a blood sample. This study may not be of sufficient size to detect meaningful changes in     these variables. However, it will provide information in regards to the preliminary efficacy,     resource requirements and feasibility. Feasibility will include: recruitment, retention and     adherence. Such information is essential for planning a more definitive trial. The     identification of exercises that target greater reductions in abdominal fat will have     important implications for the health of people with diabetes.   "
251676|NCT01144091|"     The investigators will study 2 separate groups:        -  Cardiology patients undergoing invasive coronary angiography +/- PCI (Percutaneous          coronary intervention).        -  Patients undergoing CT examination with contrast medium. All patients will receive          intravenous (I.V) hydration for 8-12h before and 36 to 48 h after angiography with 0.45%          saline 100ml/h.      All patients will receive oral N-acetyl cysteine 1200 mg twice daily, a day before, on the     day of the angiography and for another 48 hours.      In addition, patients will be assigned to receive oral pentoxyphylline (P group) or placebo     (C - control group) tablets 3 times a day one day before, on the day of the procedure and for     another 48 hours.      Baseline Serum Creatinine (S.Cr) levels in will be taken before angiography and two days     after angiography. Radio-contrast nephropathy is defined, in this study, as increase in serum     ≥ 25 % of baseline after injection of the radio-contrast agent. Pentoxyfylline is an orally     active haemorheological agent for the treatment of peripheral vascular disease,     cerebrovascular disease and a number of other conditions involving a defective regional     microcirculation. Pentoxyfylline acts primarily by increasing red blood cell deformability,     by reducing blood viscosity and by decreasing the potential for platelet aggregation and     thrombus formation (mechanism unclear). Pentoxyfylline has also proven to have a significant     anti inflammatory effect as well as anti oxidant effect, mechanisms considered to be     important patho-physiological causes of contrast induced nephropathy.   "
251677|NCT01144104|"     This trial consists of two linked substudies.      Substudy 1: Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness     Study      Substudy 2: Activating Messages for Enhancing Primary Care Practice (AMEP2): Toxicity Study      The purpose of the Effectiveness Study is to assess the comparative effectiveness of three     multimedia educational interventions (a targeted educational video, a tailored interactive     multimedia computer program, and an attention control) for increasing the likelihood that     primary care patients with significant depressive symptoms will seek appropriate care (n =     510). The primary study outcomes are provision of minimally acceptable initial care,     reductions in depression-related stigma, and improvement in depression symptoms. (See Process     of Care and Patient Outcomes in Primary Outcome Measure section.)      The purpose of the Toxicity Study is to assess the potential benefits (reduced stigma) and     harms (inappropriate prescribing) associated with three multimedia depression educational     interventions when administered to patients with few or no depressive symptoms (n = 308). The     primary outcomes relating to this outcome are reducing depression-related stigma and reducing     unnecessary prescribing. (See Toxicity in Primary Outcome Measure section.)      Both studies will look at the secondary outcome measure of patient requests for depression     treatment.   "
251678|NCT01144117|"     In a double-blind, placebo-controlled, parallel group trial, recombinant human erythropoietin     (rhEPO) (48000 IU) treatment or placebo will be administered weekly i.v. for 24 weeks: weekly     for 12 weeks and bi-weekly for 12 weeks. Methylprednisolone (MP) 1 g i.v. will be     administered before the first and second EPO/placebo administration. The 24-week treatment     period will be followed by a 24-week observation period.   "
251679|NCT01144130|"     The purpose of this study is to quantify the degree of sleep disturbances after hip or knee     replacement surgery.      Through polysomnographic monitoring the disturbances in sleep stages will be clarified.   "
251680|NCT01144143|"     The purpose of this study is to determine if an anti-inflammatory drug, called infliximab,     will reduce inflammation in the synovial lining in patients with an early stage of     osteoarthritis of the knee. It will also help determine if the study medication decreases the     accumulation of synovial fluid and prevents cartilage breakdown.   "
251681|NCT01149616|"     The purpose of the study is to determine the opiate sparing effects of intravenously     administered dexamethasone in outpatient knee surgery. Dexamethasone is a glucocorticoid with     well known antiemetic effects. However, the analgesic effects of dexamethasone have not been     adequately researched. Following surgery, patients are typically discharged home with PO     opiates to manage post-operative pain. The investigators believe that by using VAS (Visual     Analog Scale) for Pain the investigators can show that a single dose of dexamethasone can     reduce pain scales and opiate consumption post-operatively, on Post Operative Day (POD 1)     when compared to placebo.   "
251682|NCT01149629|"     One purpose of this study is to determine if taking droxidopa after eating will have an     effect on how the body processes (absorbs and eliminates) the drug in healthy elderly     subjects. Another purpose of this study is to see how the body processes (absorbs and     eliminates) one 300mg capsule compared to three 100mg capsules. This study will also evaluate     how well the body processes (absorbs and eliminates) and tolerates droxidopa when a 300 mg     capsule is given 3 times a day for a total dose of 900 mg over the course of one day.      Droxidopa is used to treat low blood pressure upon standing in patients with diseases of the     nervous system, to prevent low blood pressure in patients with kidney disease during     hemodialysis (removal of waste products of the blood), and to treat frozen gait (walking,     stepping or running) and dizziness upon standing in patients with Parkinson's disease.   "
251684|NCT01149655|"     This will be a randomized, double-blind, placebo-controlled study consisting of a screening     period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind     maintenance treatment phase (Phase 3), and a follow up period.      Subjects may be either outpatients or inpatients between screening and through the time they     reach stabilization at the end of Phase 2; hospitalization is not a study requirement.     However, eligible subjects must be outpatients at the beginning of Phase 3.      Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and     3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be     encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any     tolerability issues. The investigator will also have the option to phone the subjects and     their guardian(s) at any time to ensure clinical stability.      A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing     the interim analysis. One interim analysis is planned after 75% of the total expected number     of impending relapse events (28 events) are achieved and will be conducted by an independent     data analysis center. The DMC will make a recommendation about stopping or continuing the     study based on safety and efficacy reviews. The results of the interim analysis and     individual subject data will remain blinded to the sponsor during the course of the study     until the DMC determines that the study will conclude based on the results of the interim     analysis, or the study is completed after 37 endpoint events.   "
251685|NCT01149668|"     The purpose of this study is to determine the long-term (> 6 months) safety of PCI 24781 PO     in subjects with lymphoma.   "
251686|NCT01149681|"     This is an open-label, Phase II Clinical Trial of Aplidin® (plitidepsin) in Patients with     Primary Myelofibrosis and post polycythemia vera/essential thrombocythemia (Post-PV/ET)     Myelofibrosis.   "
251687|NCT01149694|"     This is a first-in-man study of a novel investigational botanical drug complex, PUR 0110     rectal enema, that has been shown to have potent anti-inflammatory, antioxidant and     immunomodulatory effects following in vitro and in vivo pharmacology studies, to assess the     safety and tolerability of sequential single-ascending doses in normal healthy volunteers and     to determine the maximum tolerated dose (MTD). As a tertiary objective, the study will also     investigate the presence of specific pharmacokinetic markers following the administration of     single-dose PUR 0110 at each dose level.      The study is designed as a single-center, randomized, double-blind, parallel-group,     sequential single-ascending dose, placebo-controlled safety, tolerability and pharmacokinetic     study of PUR 0110 rectal enema in 24 normal healthy male volunteers. Eligible subjects will     be randomly assigned to 4 Cohorts of 6 subjects each to receive active drug (PUR 0110 Enema)     or placebo enema as follows: 187.5 mg/60 g - Cohort 1, 375 mg/60 g - Cohort 2, 750 mg/60 g -     Cohort 3 or 1500 mg/60 g - Cohort 4. Within each Cohort, subjects will be randomized in a 2:1     ratio to receive either active treatment (PUR 0110 enema; n = 4) or placebo enema (n = 2).     Each subject will receive only 1 dose of assigned study medication and dosing of subjects     within each cohort will also be by sequential inclusion.   "
251688|NCT01149707|"     PUR 0110 is a 100% natural novel investigational medicinal product that has been demonstrated     in several in vitro and in vivo pharmacology studies to have potent anti-inflammatory,     anti-oxidative and immunomodulatory effects. This exploratory Phase 2a study is a     first-in-patient study to evaluate the safety, tolerability, biomarker effect and efficacy of     PUR 0110 rectal enema in patients with active mild-to-moderate distal ulcerative colitis     (UC).      The study is a multicenter, randomized, double-blind, parallel-group, dose-ranging,     placebo-controlled study. To be eligible for inclusion into the study, patients must either     be newly diagnosed or have on-going active mild-to-moderate distal ulcerative colitis of at     least 3 months duration confirmed in either case by flexible sigmoidoscopy and biopsy at the     Screening Visit. In addition, patients must have a modified Mayo score of ≥5 to ≤10 including     a sigmoidoscopy inflammation grade and rectal bleeding scores of ≥2 each. Eligible patients     will be randomly assigned to receive either PUR 0110 250 mg, 500 mg or 1000 mg or placebo     rectal enema in a 1:1:1:1 ratio. Patients will self-administer the assigned study medication     intrarectally once-daily at bedtime (10:00 p.m +/- 1 hour) for 2 weeks.      Patients will be evaluated for safety by adverse events, clinical laboratory tests, vital     signs, physical examination, electrocardiogram (ECG), and concomitant medications. Efficacy     evaluations will include the modified Mayo score, patient-defined response and remission,     Investigator Assessment of Ulcerative Colitis Symptom Score, Inflammatory Bowel Disease     Questionnaire (IBDQ), and biomarkers of inflammation, apoptosis and total cell death, lipid     peroxidation and in vivo oxidative stress, and antioxidant defense mechanisms in plasma,     serum, urine, feces and biopsy tissue. Patients will have a flexible sigmoidoscopy and biopsy     12 hours after the last dose of study medication.   "
251689|NCT01149720|"     This is a Phase 1, randomized, open label, 2 treatment, 2 period, 2-way crossover study, with     an extension phase design in which the steady state PK of ARQ 197 will be investigated using     the tablet administered in fed state (test treatment) and capsule administered at least 1     hour before or 2 hours after a meal (reference treatment) in subjects with advanced solid     tumors.   "
251690|NCT01149733|"     The objective of this study is to evaluate the comparative bioavailability between tamsulosin     hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.;     distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg     capsules (Manufactured by Yamanouchi Pharmaceutical Co., Japan; distributed by Boehringer     Ingelheim Pharmaceutical Inc. USA), after a single-dose in healthy subjects under fed     conditions.   "
251691|NCT01149746|"     The objective of this study is to evaluate the comparative bioavailability between Tamsulosin     Hydrochloride 0.4 mg Capsules (Teva Pharmaceuticals USA) and Flomax® 0.4 mg Capsules     (Boehringer Ingelheim Pharmaceuticals, Inc. USA), after a single-dose in healthy subjects     under fasting conditions.   "
251692|NCT01149759|"     Atopic Dermatitis (AD) or eczema is a chronic relapsing inflammatory disease that affects     1-3% of the adults and up to 25% of the children in the United States. Patients with severe     AD will be studied during a 24-week study with systemic cyclosporine (Neoral, capsule form)     to evaluate the immune suppression and pathological correlation of cyclosporine A in these     patients in order to determine the extent to which immune activation drives the pathological     epidermal phenotype.   "
251693|NCT01149772|"     The current study seeks to test the effectiveness of a talk-therapy intervention designed to     better meet the needs of chronically ill Veterans. This project looks to recruit 450 Veterans     with either chronic obstructive pulmonary disease (COPD) or heart failure (HF) who also have     symptoms of worry, stress, anxiety, or sadness. Participants will be randomly put into either     the talk-therapy intervention or enhanced usual care.      The talk therapy intervention will be provided by VA clinicians in the primary care setting     and will consist of 6 core meetings (30-45 minutes in duration) and 2 follow-up telephone     meetings. Enhanced usual care participants will receive feedback regarding the assessment     findings and educational materials on COPD and/or HF, depression and anxiety.   "
251699|NCT01149850|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     temozolomide, also work in different ways to kill tumor cells or stop them from growing.     Giving bevacizumab together with temozolomide may be a better way to block tumor growth.      PURPOSE: This phase II trial is studying how well giving bevacizumab and temozolomide     together works in treating older patients with newly diagnosed glioblastoma multiforme or     gliosarcoma.   "
251700|NCT01149863|"     Typically, the collection of blood cells for autologous stem cell transplant is done after     the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to     activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+     cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis     (removal of blood) begins the following morning. The purpose of this study is to test whether     plerixafor can instead be given 17 hours before apheresis. This timing would be more     convenient since plerixafor would be given during normal clinic hours, and so patients would     be within a clinic environment if any side effects develop.      The study will look for the activation of CD34+ cells in patients who receive plerixafor 17     hours before apheresis. We will follow the number of patients that achieve the target numbers     of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the     numbers in previous studies giving plerixafor 11 hours before apheresis.      We will also assess the safety of giving plerixafor 17 hours before apheresis.   "
251701|NCT01149876|"     The purpose of this study is to determine whether a topical Nu Skin product with or without a     galvanic spa device improves brown spots on the face. The Nu Skin product will be compared to     an over the counter moisturizer and tretinoin cream.   "
251702|NCT01149889|"     The investigators purpose is to offer active Transcranial Direct Current Stimulation (tDCS)     in patients of the investigators previous study who received either placebo or sertraline and     have not responded.   "
251703|NCT01149902|"     The purpose of this study is to determine safety and feasibility of Chemo-Immunotherapy using     cyclophosphamide, docetaxel, OK-432, and autologous immature dendritic cells for patients     with relapsed and refractory head and neck squamous cell carcinoma.   "
251704|NCT01149915|"     The primary objective of this study is to determine the maximum tolerated dose, dose limiting     toxicity, safety and tolerability of TH-302 in patients with acute leukemias, advanced phase     chronic myelogenous leukemia (CML), high risk myelodysplastic syndromes, advanced     myelofibrosis or relapsed/refractory chronic lymphocytic leukemia (CLL).   "
251705|NCT01149928|"     In this prospective, cross-sectional study, the aim was to investigate the possible role of     cord stress hormones; adrenocorticotropic hormone (ACTH), cortisol, epinephrine, sT3, sT4,     and thyroid-stimulating hormone (TSH) in the development of Transient Tachypnea of the     Newborn (TTN), via their modulatory effect on epithelial sodium channels and Na-K-ATPase.   "
251706|NCT01149941|"     The purpose of this study is to compare the rate and extent of absorption of ibuprofen 200 mg     gelcaps (test) versus Advil liquigels (reference) administered as 1 x 200 mg gelcap under     fasting conditions.   "
251707|NCT01151605|"     This study will help us understand the possible beneficial effects of insulin in     inflammation. Inflamamtion is considered to be the cause of atherosclerosis and heart     disease.   "
251708|NCT01151631|"     Cluster headache (CH) is a primary headache disorder characterized by recurrent short-lasting     attacks (15 to 180 minutes) of excruciating unilateral periorbital pain accompanied by     ipsilateral cranial autonomic signs. The 1-year prevalence of CH is about 0.1 %, the male:     female ratio is 3:1. The majority of patients have cluster periods of weeks to months with     frequent attacks which are alternated with symptom-free periods of months to several years;     the episodic from of CH. In about 10% of patients the CH is chronic (CCH) in which either no     remission occurs within 1 year or the remissions last less than 1 month. At least 10 % of CCH     patients are refractory to medical treatment or cannot tolerate the treatments.      Recent pilot studies suggest that occipital nerve stimulation (ONS) in medically intractable     CCH (MICCH) might offer an effective alternative to medical treatment. There are no     randomised clinical trials and a placebo effect cannot be excluded. Long term tolerability is     known from other indications.      Here the investigators propose a prospective, randomised, double blind, parallel group     multi-centre international clinical study to compare the reduction in attack frequency from     baseline of occipital nerve stimulation (ONS) in patients with MICCH between two different     stimulation conditions: high (100%) and low (30%) stimulation.      Following implantation there will first be a run-in phase of 10 days of 10% stimulation     intensity, followed by a stepwise monthly increase up to either 30% or 100%. Patients will be     assessed monthly by a blinded assessor. The primary outcome measure is the mean number of     attacks over the last 4 weeks of the double blind 6 month treatment period in the 100% versus     the 30% treatment group. Hereafter, in an open extension phase of 6 months, all patients will     receive 100% stimulation or the stimulation considered optimal by the patient.      Secondary outcome measures include the rate of responders (≥ 50% reduction in attack     frequency during the last 4 weeks of each treatment period), patient's satisfaction,     medication use, quality of life, mean pain intensity, economic evaluation and whether     patients would recommend the treatment to another patient. The investigators will also     investigate whether predictive factors can be identified for efficacy.   "
251720|NCT01151787|"     The primary objective of the study is to evaluate the effectiveness and safety of     cyclobenzaprine hydrochloride extended release (Amrix 15mg/day) for the prophylaxis of     chronic migraine compared to a placebo medication. A second objective, is to find out whether     there is an improvement in quality of sleep and self-reported depression in patients taking     Amrix 15mg daily. The hypothesis is that the number of migraine days per month of patients     treated with Amrix 15mg daily will be significantly lower than those patients treated with     placebo.   "
251721|NCT01151800|"     The purpose of this study is to determine whether interactive voice response (IVR) technology     can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best     practice guidelines (BPGs).      The study hypothesis is that ACS patients who are contacted by IVR technology will be more     likely to receive care as recommended in the BPGs than those followed by usual care.   "
251722|NCT01151813|"     This is a Phase II within-subjects double-blind placebo-controlled human laboratory study.     The purpose of the study is to determine the efficacy of varenicline (Chantix) for reducing     cue-induced cocaine and alcohol craving.   "
251767|NCT01152398|"     The current trial, BNIT-BR-003, will evaluate the safety and biological activity of a fixed     dose of MVA-BN®-HER2 following adjuvant chemotherapy in patients with HER-2-positive breast     cancer.      The intent of vaccination is to induce a combined antibody and T-cell anti-HER-2 immune     response, which is intended to target HER-2-expressing tumor cells, and may induce tumor     regression or slow progression of disease.   "
251709|NCT01151644|"     The prognosis of rheumatic diseases has improved considerably with development of therapy.     However, infections are considered the most important cause of morbidity and mortality in     this group of patients. One of the ways to prevent such complications is vaccination. In     2009, a new pandemic strain of influenza virus (A/H1N1/2009) has emerged raising major     concerns for public health. Patients under immunosuppressive therapy have indication for     immunization against influenza virus H1N1. There are, however, concerns about possibility of     reactivation of autoimmune diseases, determine adverse events and insufficient immunogenicity     in these patients. The lack of studies evaluating the efficacy and safety of the vaccine     against influenza A(H1N1)/2009 in these rheumatic patients led to the development of this     research. The objectives of this study are to evaluate the humoral response and safety of the     vaccine virus A(H1N1)/2009 in immunosuppressed patients with rheumatic diseases compared to     healthy controls. We have recruited 400 patients with rheumatoid arthritis, 350 with     spondyloarthritis, 1000 with systemic lupus erythematosus (SLE), 150 with dermatomyositis     (DM), 100 with mixed connective tissue disease, 150 with systemic vasculitis, 250 with     systemic sclerosis (SSc) , 100 with Sjögren's syndrome, 100 with antiphospholipid syndrome,     100 patients with juvenile idiopathic arthritis, 80 with juvenile SLE, and 80 with juvenile     DM, followed at our Rheumatology Outpatient Division and Unit Pediatric Rheumatology     Children's Institute, HC-FMUSP. The control group was recruited were 200 healthy employees of     ICHC-FMUSP. Informed consent was obtained from all participants and the study was approved by     the Local Ethical Committee. All subjects were vaccinated against influenza virus     A/(H1N1)/2009 (vaccine approved and supplied by Instituto Butantan-São Paulo). Blood samples     was collected to measure levels of antibodies inhibiting hemagglutination by influenza virus     A (H1N1)/2009 immediately prior to vaccination and 21 to 28 days after vaccination.,     Participants fulfilled a questionnaire on the immediate side effects of the vaccine. All     patients with rheumatoid arthritis, spondyloarthritis, SLE, DM, systemic vasculitis, juvenile     idiopathic arthritis, juvenile SLE, and DM were assessed before and 21 days after vaccination     for clinical, laboratory parameters of disease activity as well as treatment. Continuous     variables will be compared by t-test to evaluate differences between patients with rheumatic     diseases versus healthy controls. Differences between categorical variables will be evaluated     using the chi-square or Fisher exact test. Statistical significance was set at p<0.05.   "
251710|NCT01151657|"     The study aims to investigate the effect of probiotics on IBS-patients symptoms compared to     placebo, when given for 6 months.      By draw the investigators give IBS patients, in the age of 18-50 years, capsules with either     probiotics or placebo. The patients are to take 2x2 capsules / day for 6 months. The patients     are followed for 1 year. They are seen after 3, 6 and 12 months, and are followed by means of     monthly letters.      The capsules contain 3 different probiotic strains - Lactobacillus paracasei ssp paracasei     F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12. The dose is 2 x 109 - 10 x 109     CFU/capsule.      The hypothesis is, that there is a clinical difference between the group receiving probiotics     and the group receiving placebo.   "
251711|NCT01151670|"     RATIONALE: Pioglitazone hydrochloride may be effective treatment for cognitive dysfunction     caused by radiation therapy.      PURPOSE: This phase I trial is studying the side effects and best dose of pioglitazone     hydrochloride in preventing radiation-induced cognitive dysfunction in treating patients with     brain tumors.   "
251712|NCT01151683|"     Introduction: Magnesium has been the target for many experimental and clinical studies due to     the negative correlation between its serum and intracellular levels and the prevalence of     hypertension and other cardiovascular diseases.      Objective: To evaluate the effects of magnesium supplementation in hypertensive patients who     are under diuretic treatment, including correlation of clinical and nutritional parameters     with structural and functional aspects of the macrocirculation.      Methods: A prospective, randomized, double blind, placebo controlled study will be performed     in hypertensive patients, aged between 40 and 65 years-old, in regular use of thiazidic     diuretic as antihypertensive monotherapy,. The patients will be divided in two main groups     according to supplementation with placebo or magnesium chelate 300mg twice a day (total of     600mg magnesium element per day). Before and after 3 and 6 months of supplementation, the     patients will be submitted to clinical and nutritional evaluation, biochemical analysis,     including intracellular magnesium measurement, and study of the macrocirculation with     ambulatory blood pressure monitoring, analysis of flow-mediated dilation of brachial artery,     measurement of carotid intima-media thickness, and carotid-femoral and carotid-radial pulse     wave velocity to estimate central and peripheral arterial stiffness.      Analysis: Data will be expressed as mean±epm. Statistical analysis will be performed using     software Prism® (GraphPad, version 5.0). Continuous variables in each group will be compared     using t test, and P<0.05 will be considered statistically significant.   "
251713|NCT01151696|"     Unexpected acute pain in an emergency setting causes anxiety, insecurity, and stress that can     diminish perceptions of control over pain and diminish ability to decrease pain. This may     interfere with the opioid treatment and poses the question of whether an anxiolytic drug     added to the morphine titration could relief pain and/or anxiety. This randomized     double-blind group clinical trial is designed to determine the efficacy and safety of     hydroxyzine in addition to a conventional intravenous morphine titration protocol.   "
251714|NCT01151709|"     This is a questionnaire study aimed at learning about physicians' views on the treatment of     Gout.   "
251715|NCT01151722|"     Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative     diabetic retinopathy. There have been efforts to lower the incidence of postoperative     vitreous hemorrhage such as preoperative bevacizumab injection. Bevacizumab (Avastin) is a     potent inhibitor of angiogenesis and has been shown to decrease retinal and iris     neovascularization in proliferative diabetic retinopathy. Recently there have been reports     showing that preoperative bevacizumab injection could reduce intraoperative bleeding from     abnormal vessels and could make surgery easier and more successful. Our hypothesis is that     intraoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by     inhibiting the vessel formation after surgery.      We started the prospective randomized comparative study to determine the effect of pre and     intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic     vitrectomy in comparison to vitrectomy without any adjuvant drug.   "
251716|NCT01151735|"     The study hypothesis is that treatment of Hereditary Angioedema at the time of prodromal     symptoms will decrease morbidity associated with the disease   "
251717|NCT01151748|"     Phase II study of selective intra-arterial infusion of chemotherapy for intraocular     retinoblastoma   "
251718|NCT01151761|"     The purpose of this study is to determine progression-free survival at 12 months for     stereotactic body radiotherapy (SBRT) and chemotherapy for unresectable hilar     cholangiocarcinoma (CCA).   "
251719|NCT01151774|"     The study doctors are trying to determine if the TEE measurements from your stomach are     helpful in measuring the blood flow to the kidneys.   "
251804|NCT01152879|"     This study is being done to examine the effect of Parenteral (intravenous) nutrition support     in the home setting on quality of life in cancer patients. In addition, this study is being     done to examine the effect of home parenteral nutrition on the use of pain and anti-nausea     medication.   "
251723|NCT01151826|"     Primary graft dysfunction (PGD or lung reperfusion edema) complicates 10 to 20% of lung     transplantations and leads to severe early and late postoperative complications. Its     pathophysiology remains unclear but may involve graft ischemia-reperfusion, increased     vascular permeability, pneumocyte dysfunction and finally alveolar flooding that impair gas     exchange and blood oxygenation.Its substrate, namely extravascular lung water (EVLW), can now     be clinically measured with minimally invasive Intensive Care Unit monitors (PiCCO2®, Pulsion     Medical Systems) that also provides a physical estimate of pulmonary vascular permeability     (PVPI). Similarly, biochemical correlates of vascular permeability (ICAM-1) and pneumocyte     dysfunction (RAGE) can now be measured in plasma samples. Our study aims at quantifying     physical and biochemical markers of PGD and assess their diagnosis and prognosis values.   "
251724|NCT01151839|"     Carcinoma of the esophagus is the among the most common cancers in Indian population. While     adenocarcinoma is more common in western countries, in India squamous cell carcinoma is the     more frequent form. Surgery is the standard treatment in resectable lesions, but survival is     poor. Adjuvant and neoadjuvant treatment therapy is used with an aim to improve the results.     Though few randomized trials have addressed the issue of neoadjuvant chemoradiotherapy, the     methodology was inhomogeneous and the populations studied were different. The investigators     will be conducting a randomized controlled trial in patients with squamous cell carcinoma of     the esophagus. Preoperative chemoradiation followed by surgery will be compared with surgery     alone.   "
251725|NCT01151852|"     The objective of this study is to compare the clinical outcomes following resumption of     dosing (re-challenge) with Imatinib plus best supportive care versus placebo plus best     supportive care in patients with advanced/incurable Gastrointestinal Stromal Tumors following     failure of prior imatinib and sunitinib therapies.   "
251726|NCT01151865|"     The primary aim of the DahLIA trial is to determine, in patients with ICU-associated delirium     and agitation who are otherwise pathophysiologically stable (as defined), the number of     ventilator-free hours in the incident ICU admission in the 7 days following commencement of     trial medication, in patients randomised to receive dexmedetomidine or placebo while     receiving all other aspects of standard care.      The null hypothesis assumes no difference in the median number of ventilator-free hours in     this ICU admission in the following 7 days, between patients receiving dexmedetomidine and     placebo for ICU-associated agitation and delirium.   "
251727|NCT01151878|"     The purpose of this study is to determine whether administration of glucomannan (dietary     fiber) is effective in treating functional constipation in children.   "
251728|NCT01151891|"     There are no evidence (research) based guidelines for treatment of early, closed puncture     wounds of the feet in diabetics. Surgeons usually see only the limb- and life-threatening     consequences of puncture wounds of the feet in diabetics, and are therefore tempted to     advocate more aggressive, preemptive, invasive primary treatment for all such wounds,     assuming, from this blinkered perspective that all such wounds progress to serious infection.     This study is designed to determine the natural history of puncture wounds of the feet in     diabetics, specifically, whether all become infected or whether some do heal without any     surgical intervention. It requires administration of a questionnaire to 188 known diabetics     attending 11 selected outpatient health care centers in the parish of St. James, Jamaica.   "
251729|NCT01151904|"     This study will evaluate the safety and efficacy of patients switched from latanoprost     monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol     0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.   "
251730|NCT01151917|"     Glycemic control is rapidly restored in patients with insulin resistance after bariatric     surgery, in particular after the mal-absorptive one (i.e. Bilio-pancreatic diversion, BPD).     To evaluate the mechanisms allowing restoration of insulin sensitivity after BPD the     investigators aimed at identifying by using a proteomic approach plasma proteins or peptides     that may be involved in the remarkably fast and explicit restoration of insulin sensitivity.     In addition to the unbiased proteomics approach, a selection of recognized markers for     metabolic control will be measured. These efforts all aim at an increased understanding of     how insulin sensitivity is regulated and may provide novel ideas of how to treat insulin     resistance and type 2-diabetes.   "
251731|NCT01151930|"     The primary objective is to characterize the safety profile of long-term exposure to SCB01A     when administered to cancer subjects with advanced solid tumors. Furthermore, the efficacy     profile will also be explored in this study.   "
251732|NCT01151943|"     Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia,     will be randomized to undergo either TAP block or incisional infiltration with local     anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen,     nefopam and ketoprofen. Short acting oral morphine will be given as a rescue treatment in     case of severe pain.   "
251733|NCT01151956|"     Objective: To show how dermatologists treat actinic keratoses with imiquimod 5% cream in     their daily clinical routine.      Design: Prospective, non-interventional, observational, multicenter clinical study.      Setting: Offices of 93 non hospital based Austrian dermatologists. Participants: Inclusion of     the 463 patients into the study was solely based on the treatment decision of the     dermatologist and the patients will.      Interventions: No specific interventions except suggested time points of visits with     pre-defined documentation forms. The therapy of actinic keratoses followed the imiquimod     label (3x/week for 4 weeks, 4 therapy free weeks, another 3x/week for 4 weeks, when needed)     Main outcome measure: Information about the typical imiquimod patient, therapeutic course,     treatment decisions, safety and satisfaction of patients/dermatologists.   "
251754|NCT01152229|"     The objective is to describe and quantify levels of platelet reactivity in three different     cohorts of patients taking thienopyridine: patients who report nuisance bleeding, patients     who report alarming bleeding, and patients who report no nuisance or alarming bleeding. The     investigators hypothesize that patients with nuisance or alarming bleeding events on     maintenance thienopyridine therapy will have lower levels of platelet reactivity than     patients without nuisance or alarming bleeding on thienopyridine therapy.   "
251755|NCT01152242|"     The purpose of this study is to evaluate whether the within-subject variation in duration of     action and time-action profile of glargine measured by isoglycemic clamp will be below     prespecified levels.   "
251734|NCT01151969|"     The main objective is to measure the effectiveness of a new intervention to decrease use of     services of primary care frequent attenders (FA).Among the secondary objectives are to     evaluate the cost-effectiveness and cost utility of the new intervention compared with usual     care.      METHODS: There will be a randomized controlled trial with cluster assignment. It will take     place in the field of primary care in the city of Malaga.It will be evaluated a new     multicomponent intervention called 7H (7 Hypothesis). This intervention will be applied on     the FA by their family doctors in the intervention group. In the control group will be     developed usual cares.      The main outcome is the total of visits of FA at 12 months of the follow-up. The secondary     outcomes include changes happened in biopsychosocial health, satisfaction, and quality of     life measurements. The investigators will assess the dependent and independents (from FA,     general practitioner [GP] and health centres) variables at baseline, and 12 months. At     baseline it will be include a random sample of 450 FA (225 for each arm), belonging to 30     family doctors of 10 health centres. It will be performed linear regression multilevel models     with 4 levels (time, patient, doctor and health centre) to evaluate the effectiveness of the     intervention. . Moreover will be undertaken multivariate gamma and quantile regressions to     assess the cost-effectiveness and cost-utility respectively of the new intervention versus     usual cares, estimating their standard errors by bootstrap calculations.   "
251735|NCT01151982|"     The main objective is to measure the effectiveness of a new intervention for primary     prevention of major depression based on the level and profile of risk of primary care     attendees. Among the secondary objectives is to evaluate the cost-effectiveness and     cost-utility of the intervention versus usual care. METHODS: This is a cluster, randomised     controlled trial of a community intervention with cluster at the level of practice. It will     be undertaken in primary medical care in 7 Spanish cities and 5 autonomous communities.The     aim is to evaluate a new intervention for primary prevention of major depression based on     patients' level and profile of risk. Family doctors in the intervention practices will     provide the intervention for patients at risk. Patients at risk who are recruited in control     practices will receive usual primary care. The main outcome is the accumulated incidence of     major depression (measured by CIDI) during the follow-up. The investigators will assess main     outcomes and other covariables at baseline, 6, 12, and 18 months. A random sample of 3,381     primary care attendees (1,690 for each arm), aged 18-75 and without major depression will be     recruited in 70 health centres (140 family doctors) in 7 cities. The investigators shall     undertake a logistic regression multilevel model with 4 levels (time, patient, doctor and     health centre). The investigators shall also undertake multivariate gamma and quantile     regression to assess respectively the cost-effectiveness and cost-utility of the new     intervention versus usual care, estimating their standard errors by bootstrap.   "
251736|NCT01151995|"     This pilot project will evaluate Internet-based remote access to electronic clinical systems     to support study monitoring tasks. The project engages two NIH-sponsored clinical trial     networks (adult: ARDS network; pediatrics: ChiLDREN network) at five trial locations and two     coordinating centers located across four states, which engages three collaborating     NCRR-funded CTSA institutions. Each study location uses different electronic clinical systems     and remote access methods, replicating the diversity of clinical applications and access     methods found across large research networks. The results of this pilot project will inform a     broader project that will engage all trial sites with electronic clinical systems in both     national networks.      This proposal extends Specific Aim 1.2 of the Research Informatics Integrated Core (RIIC) in     the parent grant (UL1 RR025780) for the Colorado Clinical and Translational Sciences     Institute (CCTSI): The RIIC will develop and implement tools and services that will….(2)     support the efficient execution of the CCTSI translational research projects. (CCTSI grant     page 1053). Specific Aim 1.2 proposes to develop new informatics methods that increase the     translational research capacity by improving the efficiency of executing clinical studies.     Reducing barriers to study monitoring via remote access will enable new innovative approaches     to protecting study subjects, ensuring study data quality and documenting regulatory     compliance. An example of a completely new model for study monitoring could be continuous     study monitoring from any coordinating center to any study location in the Internet-connected     world.      We hypothesize that remote monitoring will demonstrate substantial improvements in study     monitoring efficiency, effectiveness, and possibly overall costs when compared to present     monitoring plans that require a prolonged on-site visit by a study monitor from the     coordinating center. We do not claim that remote study monitoring will replace all monitoring     tasks . But, for monitoring tasks that require access to electronic clinical data, we seek to     demonstrate that remote access can enable more frequent SDV and regulatory documentation     compliance, which in turn could facilitate new models of continuous study monitoring. The     results of these studies would support improvements in study monitoring that would both     significantly reduce the cost of conducting large multi-center clinical while improving the     safety of those patients who are enrolled into these trials   "
251737|NCT01152008|"     We aim to test the hypothesis that Laser speckle contrast imaging allows for the measurement     of cutaneous blood flow during exercise.   "
251738|NCT01152021|"     This is a prospective, open label randomized study. The purpose of this study is to compare     propofol with dexmedetomidine for pediatric monitored anesthesia care for MRI, specifically     identifying important patient demographics and looking at important outcomes including     adverse events.   "
251739|NCT01152034|"     This study aims to develop the MAPS(M,Monitoring;A,Assessing;P,Preventing or Reducing     Relapse;S,Smart goal setting) group therapy model for bipolar disorder patients as other     adjuvant clinical treatment and develop the instruments for evaluating the severity of     bipolar symptoms. The investigators insist to provide the psychosocial intervention for     bipolar patients in the general hospital and offer appropriative adjuvant intervention except     current psychiatric biological treatment.      This study is a one-year project. First, the investigators like to translate the Depression,     Anxiety and Stress Scale (DASS) and the Altman Self-Rating Scale for Mania (ASRM) to Chinese     and finish the reliability and validity study. Second, the investigators would like to     develop the MAPS group therapy to enhance bipolar patients' insight, increased life quality     and decrease suicidal ideation. This study is a case control study. All cases recruit from     the psychiatric outpatient department of one medical center. The inclusion criteria are     diagnosed as bipolar disorder, age from 18 to 65 and agree to sign the inform consent. The     excluded criteria are hard to communicate, with acute psychiatric feature and severe physical     illness. The investigators plan to hold the MAPS group three times and predetermine to     recruit totally 30 patients as the case group. As to the control group, the investigators     also recruit from the psychiatric outpatient department and those who treat as usual by     control their gender, age and the same diagnosis as bipolar disorder. The only one different     factor between the case group and the control group was attending the MAPS group therapy or     not. In MAPS group therapy, two facilitators work with ten clients with twelve weekly     sessions and three monthly booster sessions. Self-report rating scales (DASS and ASRM) are     completed at the beginning of each session. The investigators use DASS and ASRM to evaluate     the severity of bipolar symptoms; BSS for suicidal ideation; SF-36 for life quality. The     hypothesis is patients attended to MAPS group therapy have better symptoms control, lower     suicidal ideation, better life quality and less use emergency department or admissions than     those who didn't attend the group therapy.   "
251740|NCT01152047|"     The investigators have seen that oxytocin lowers satiety in healthy subjects. Patients with     dyspepsia suffers from decreased accommodation and increased satiety postprandially. The     investigators now want to examine whether oxytocin may diminish symptoms in these patients.   "
251741|NCT01152060|"     Lamivudine treatment for HBV-DNA negative HBV-GN patients.   "
251756|NCT01152255|"     This study will evaluate the safety and tolerability of MK6186 and the change from baseline     in plasma HIV-1 RNA after seven consecutive days of dosing.   "
252588|NCT01162226|"     This study will be carried out to determine the effectiveness of in-home computer games     played by a person with Parkinson's disease for 50 minutes 3 times a week on measures of     standing and walking balance.   "
251742|NCT01152073|"     Great controversy exists about the feasibility and safety of a product that can be employed     for self-directed cholesterol reduction. The position that self-directed cholesterol lowering     could lead those that do not need lower cholesterol to take the product is likely unfounded.     This is because there is no convincing evidence to suggest that there are cholesterol levels     so low that a lower one would not be beneficial or conversely be dangerous. Ample evidence     exists that cholesterol causes cardiovascular disease and that lower cholesterol places     individuals and populations at lower risk. Because of the high cost, insurance concerns and     suboptimal access to physician care, a self-directed, effective and safe approach to     cholesterol maintenance or reduction would be very desirable. Drug therapy also has been     associated with suboptimal results. Though a new concept that addresses cholesterol by     several mechanisms simultaneously has been shown to be more consistently effective and with     better tolerability, there is still a need for a self-directed cholesterol optimizing     alternative. It is, therefore, our intent in this study to evaluate certain foods,     specifically nutraceutical containing fruit flavored drinks in the hopes that they can be     proven a safe and effective alternative approach for cholesterol management.   "
251743|NCT01152086|"     Suicide is a major public health issue with estimated 1 million deaths worldwide within the     last year. Physical activity and nature recreation might be protective factors against     suicidal behaviour, suicidal ideation and contributing factors like depression and     hopelessness.      In this randomized controlled cross-over intervention study the investigators aim to     investigate the physical and psychological effects of a 9 weeks hiking program in chronically     suicidal patients. The investigators aim to enroll 24 patients suffering from chronic     suicidality, defined as at least one attempted suicide and a hopelessness greater than 26 in     Beck's Hopelessness Scale summary score. At baseline patients will undergo pre-tests     including questionnaires to assess suicide ideation, hopelessness, depression, anxiety,     quality of life and health-related physical activity, physiological investigations to assess     exercise capacity and blood investigations. Randomly assigned 12 patients start with the 9     weeks supervised mountain hiking program followed by a 9-week-period without supervised     exercise program. The other 12 patients start with 9 weeks without supervised exercise     program followed by a 9-week-period of supervised mountain hiking program. The mountain     hiking program includes 2 training sessions per week with a duration of 3 hours per session.     The hiking intervention will be performed within 70-85% of heart rate reserve and gymnastics     for body and nature perception, mobilisation and stretching will enrich the training program.     Further investigations including questionnaire-assessments, assessment of exercise capacity     and blood investigations will be scheduled 9 and 18 weeks after the study start. In addition     a daily assessment of several suicide risk-factors based on a web-based questionnaire will be     done over the full study period. Within this mountain hiking program the investigators hope     to reduce hopelessness in chronically suicidal patients.   "
251744|NCT01152099|"     Hypothesis:      To know the utility of manual lymph drainage (MLD) as part of the Physical Complex Therapy     has turn out relevant because of the exclusive dedication that it supposes to the therapist.     To date, the evidence-base for MLD is very limited and only two studies analyze its     relevance. The first study measured the effect of compression bandage with or without MLD.     The group receiving compression and MLD had a significant reduction in limb volume and     decreased pain, despite the fact the MLD was given only for one week (Johansson et al.,     1999). A further study investigated the effect of eight sessions of MLD over two weeks in 42     women with breast cancer-related lymphoedema, and the findings suggested that MLD do not     contribute significantly to oedema reduction, although the MLD course was relatively short     and the study group was limited to those with mild to moderate swelling (20-30 % of     difference). Information about the quality of life, using the questionnaire EORT QLQ-C30 was     gathered but the results were not considered in the final assessment (Andersen and Cabbage     2000).      Similar studies would provide comparative and enlightening information with regard to the     previous results. The investigators could determine if the MLD, in spite of not obtaining an     improvement in the volume of the lymphoedema, provides a benefit in the reduction of the     symptoms related to it.      The investigators hypothesized that MLD does not contribute significantly in volume limb     reduction but it provides a clinical improvement regarding the quality of life according to     the questionnaire EORT QLQ-C30.      For the calculation of the sample size the investigators depart from the following     assumptions:      The effect of the standard treatment on the control group control will produce an average     volume limb reduction of 5 %.      The effect of the treatment in the experimental group will be an average of the 25 % (a minor     difference of effects would indicate a discreet effect of the tested treatment). The     investigators also assume that, the standard deviation will be similar in both groups and     near to 25 %. With this information and for an alpha risk of 0.05 and a power of 0.80 the     calculation of the sample size is 20 patients in every group. Considering a rate of     withdrawal of 30 % in every group, the appropriate sample size is 58 patients assigned in two     groups of 29 patients.      Main aim:      To analyze the effectiveness of Manual Lymph Drainage (MLD) in the treatment of     postmastectomy lymphoedema in order to reduce the volume of lymphoedema      Secondary aims:      To analyze the duration of the reduction of the lymphoedema in the time. To analyze the     improvement in the concomitant symptomatology of the lymphoedema using the results of two     quality of life tests validated in Spanish: EORTC QLQ-C30 version 2.0, for the cancer in     general and EORTC QLQ-BR23 specifically for the breast cancer. In particular, the items     refering to the upper extremity (47, 48, 49) and to the corporal image (39, 40, 41, 42) and     in which the higher the score the worse the result.      Methodology:      Researching Project with methodology of randomized, controlled clinical trial. Group A or     Control: patients with standard treatment (care the skin, exercise and measures of     compression -bandage for one month and later a sleeve of compression).      Group B or Experimental: patients with standard treatment (care of the skin, exercise and     measures of compression (bandage for one month and later a sleeve for lymphoedema) and in     addition they receive Manual Lymph Drainage Main variable: Volume reduction of the affected     arm after the treatment expressed in percentage.      Number of patients: 58 women.   "
251745|NCT01152112|"     The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue     Removal System when used by community gynecologists in an office setting for the treatment of     patients with symptomatic intrauterine polyps and submucosal fibroids.   "
251746|NCT01152125|"     Osteoarthritis is a leading cause of chronic disability in elderly and the risk of disability     attributed to osteoarthritis is as great as or greater than due to any other medical     condition in that age group. Several cross sectional studies have demonstrated an age related     increase in the prevalence of osteoarthritis of knee(5). Results of survey are similar with     most surgeons reporting 50+ years age group being commonest at initial presentation and that     the incidence increases with advancing age. Interestingly some surgeons have noticed earlier     occurrence of osteoarthritis in 40+ years age group and one has to be careful to screen for     secondary causes in this younger age group patients.      While pain relief is the primary treatment goal of osteoarthritis medications, localized     inflammation may also be relieved by using certain drugs. Managing osteoarthritis pain can     involve medications, natural remedies, exercise, weight loss, joint protection, mobility     aids, assisted devices and more.      Stem cell therapy, using cells extracted from the same patient or suitable alternative human     sources, targets diseases which are either incurable or with no complete or effective     treatment available in the traditional healthcare system. Since this therapy is based on the     concept of regenerating damaged cells in the injured or disease-affected areas of the body,     it is called regenerative medicine      Autologous stem cells provide an attractive option for osteoarthritis patients and their     clinicians.      In our present study we want to evaluate the safety and efficacy of autologous bone marrow     derived stem cells in treatment of Osteoarthritis for therapeutic chondrogenesis through     delivery of stem cells into the knee joint space in ten Indian patients.   "
251747|NCT01152138|"     The aim of this study is to determine whether a closed cell stent design may reduce distal     embolization and no reflow during primary percutaneous coronary intervention (PPCI) for acute     ST-elevation acute myocardial infarction (STEMI) compared to an open cell stent design. The     study population will include all consecutive patients admitted for acute STEMI and treated     with PPCI within 12 hours from symptom onset.   "
251748|NCT01152151|"     The aim of this project is to evaluate the efficacy of electronic reminder letters versus     postal reminder letters on general practices adherence to clinical quality guidelines     regarding Point Of Care Testing (POCT).   "
251749|NCT01152164|"     The goal of this study is gathering informations about patients' quality of life after     combined modality treatment of rectal cancer to evaluate how combined modality treatment for     rectal cancer affects patients' quality of life. The findings of this study may provide us     important information that can be used in treatment decision and to develop programs to     improve quality of life of patients with rectal cancer.   "
251750|NCT01152177|"     The aim of this project is to evaluate the efficacy of electronic reminder letters versus     none on general practices adherence to clinical quality guidelines regarding Point Of Care     Testing (POCT). The investigators hypothesize, that electronic reminder letters may increase     adherence.   "
251751|NCT01152190|"     The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for     8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of     Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate     transition zone.   "
251752|NCT01152203|"     The goal of this clinical research study is to find the highest tolerable combination dose of     bendamustine and bevacizumab that can be given to patients with advanced cancer. The safety     of the drug combination will also be studied.   "
251753|NCT01152216|"     An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of     dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on     Donepezil.   "
251766|NCT01152385|"     The purpose of this study is to compare the effect on glucose control of 3 different AZD1656     dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as     evaluated by the change in HbA1c from baseline to the end of treatment at 4 months.   "
251757|NCT01152268|"     Despite the known adverse effects of specific cancer treatments on fertility, only 18-26% of     at-risk adolescents and young men cryopreserve sperm prior to cancer treatment in the US:     These already less than optimal rates of sperm banking are even lower among adolescents who     have increased anxiety at cancer diagnosis, are lower in age and socioeconomic status, of     Evangelical religious orientation, or are diagnosed with leukemia/lymphoma: It is not clear     why sperm banking is underutilized, particularly in light of the high priority that survivors     of childhood cancer place on fertility and the high psychological distress associated with     fertility loss. Studies addressing sperm banking among adults with cancer suggest that     factors such as poor physician communication and the resulting lack of fertility-risk     knowledge by patients contributes to the low frequency of sperm cryopreservation. No     well-designed studies have examined risk factors associated with failure to bank sperm among     adolescents with cancer, a developmentally distinct population ripe for intervention.      This study plans to enroll 206 adolescent males and 412 parents/guardians.   "
251758|NCT01152281|"     Unfortunately, people most at risk for HIV are the least likely to enroll and remain in     prevention programs. In our past work, we have learned how to increase enrollment in such     programs among this group. We have identified and addressed previously ignored     gender-specific and client self-validation issues that conventional interventions often leave     not only uncontrolled, but often biased against participation. The present work will extend     these methods from enrollment to retention.      We intend to recruit a sample of 656 at-risk participants through our collaboration with the     Duval County, FL Health Department for our randomized, double-blind trial. Our study will     investigate if a meta-intervention video designed for empowering participants as agents of     their own change can increase the number of attended sessions relative to a control condition     without such a video. This trial will also determine if a meta-intervention video addressing     various emotional/social and instrumental benefits of an HIV-prevention-counseling     intervention can also increase the number of attended sessions. These two factors will be     crossed, and their effects on retention will be estimated for different genders and     ethnicities. Effects on clients' attention to the return sessions as reported by the     counselor will also be explored among participants who return.      We will also conduct mediator analyses for investigating if the meta-intervention has     mediating influences on corresponding expectations about the return counseling session. As     the inclusion of meta-cognitive measures can alter the efficacy of the intervention, half of     the sample will receive measures immediately (0-10 minutes) after exposure to the     meta-intervention, before attendance to the next session is registered. The other half will     not complete these measures.   "
251759|NCT01152294|"     The purpose of this randomized controlled trial is to examine the impact of a patient     decision aid on the quality of decisions about managing symptoms of menopause. In particular,     we will examine whether the decision aid increases knowledge about menopause/managing     menopause symptoms and concordance between goals and treatment choices.   "
251760|NCT01152307|"     The purpose of this randomized controlled trial is to examine the impact of a patient     decision aid on the quality of decisions about managing symptoms of depression. In     particular, we will examine whether the decision aid increases knowledge about     depression/managing depression symptoms and concordance between goals and treatment choices.   "
251761|NCT01152320|"     Spirometry is a recommended component of asthma diagnosis and treatment in the primary care     setting, yet few primary care providers report routine use of spirometry in the provision of     care for their asthma patients. Misclassification of asthma severity has been reported when     assessment is based on symptoms alone. This misclassification can lead to inadequate     treatment that may result in increased morbidity and increased healthcare utilization/cost.     However, even when spirometry is utilized to aid in asthma severity classification, primary     care providers have a high rate of failing to meet the quality goals for testing established     by the American Thoracic Society.      The goal of this study is to evaluate the effectiveness of the Spirometry Fundamentals™ tool     in training primary care providers and their staff in producing high-quality flow-volume     curves as compared to existing training modalities and to gather information in a     'real-world' setting that can be used to improve Spirometry Fundamentals™.   "
251762|NCT01152333|"     Scientists have discovered a number of hormones that control our feelings of hunger and     fullness. One particular hormone, called GLP-1, has been associated with feelings of hunger     and fullness. The overall purpose of this study is to look more closely at how GLP-1 changes     these feelings and to observe how these hormones affect the brain's function. To do this,     volunteers will be asked to come to the clinic for a screening visit, and 2 study visits.     This is an outpatient study with a screening visit which will last about an hour and the two     subsequent study visits for about 3 hours each. During the study, patients will receive a     drug that blocks the effect of a hormone made in the gut. We will take a series of blood     samples to measure hormones and use functional magnetic resonance imaging (MRI) to take     pictures of the brain. Understanding the action of these hormones in the brain may eventually     lead to new ways to help people avoid obesity or lose weight.   "
251763|NCT01152346|"     The purpose of the study is to determine the bioavailability of Azacitidine for Injection     relative to Vidaza® in MDS patients under fasting conditions. The data will be evaluated     statistically to determine if the products meet bioequivalence criteria.   "
251764|NCT01152359|"     Obesity is increasingly common and can lead to decreased quality of life, increased medical     and psychiatric illness, high health care costs, and early mortality. The problem of obesity     is as great in veterans as it is in the general public. Adherence to dietary therapy for     obesity is often inadequate, possibly because patients' food preferences are not considered     during dietary counseling. Allowing patients to choose a diet based on their food preferences     may increase their motivation to adhere to diet counseling. This, in turn, could enhance     their weight loss success and, ultimately, reduce the many health complications and costs of     obesity. The proposed study will examine whether assessing a person's food preferences, and     then allowing the person to choose from two commonly prescribed diets, results in greater     weight loss success.   "
251765|NCT01152372|"     Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects     and those with type 2 diabetes mellitus   "
252620|NCT01162642|"     The purpose of this study is to determine whether green tea may lower the risk of certain     cancers.   "
251768|NCT01152411|"     Chronic renal failure (CRF, or chronic kidney failure, CKF, or chronic kidney disease,     CKD) is a slowly progressive loss of renal function over a period of months or years and     defined as an abnormally low glomerular filtration rate, which is usually determined     indirectly by the creatinine level in blood serum.      CRF that leads to severe illness and requires some form of renal replacement therapy(such as     dialysis) is called end-stage renal disease (ESRD). While renal replacement therapies can     maintain patients indefinitely and prolong life, the quality of life is severely affected.     Renal transplantation increases the survival of patients with stage 5 CKD significantly when     compared to other therapeutic options; however, it is associated with an increased short-term     mortality (due to complications of the surgery).      In view of the above, there is definitely an urgent need for finding different methods of     treatment for these patients who cannot undergo established modalities of treatment or these     have been tried unsuccessfully hence the inadequacy of current treatment modalities and     insufficiency of donor organs for transplantation have driven a search for improved methods     of dealing with renal failure. The rising concept of cell-based therapeutics has provided a     framework around which new approaches are being generated, and its combination with advances     in stem cell research stands to bring both fields to clinical fruition. Since CRF affects a     large number of these patients who will lose their productive life, stem cell implantation     can offer some promise of improved health.      In our present study, we want to evaluate the safety and efficacy (to know / observe for     Proof of concept in five indian patients) if any, of autologous bone marrow derived stem     cells injected into the Renal Artery in five (initially five patients, can be increased to     ten patients after observing the initial results) patients with Chronic Renal Failure.   "
251769|NCT01152424|"     Acute eosinophilic pneumonia (AEP) is diagnosed by cell count analysis of bronchoalveolar     lavage fluid. However, the performance of bronchoscopy is not easy for patients with AEP,     because they usually have hypoxia. Exhaled nitric oxide (FeNO) is usually elevated in the     patients with eosinophilic inflammation such as asthma, but there is no previous studies FeNO     in the patients with AEP. Investigators hypothesized that FeNO elevated significantly in     patients with AEP, and FeNO can be used as non-invasive diagnostic method in patients who are     clinically suspected with AEP, especially when the performance of bronchoscopy is difficult.   "
251770|NCT01152437|"     This Phase II study is open to patients with metastatic colorectal cancer who have tried but     failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have     received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab,     panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral     oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or     cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all     receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW     2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the     effectiveness of BIBW 2992 in patients with KRAS mutated cancer.   "
251771|NCT01152450|"     Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety     of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for     the compliance and convenience of the patient in comparison to placebo. Further the rationale     is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by     the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily     (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent     asthma.      Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to     tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once     daily (in the evening) or 2.5 µg tiotropium twice daily.   "
251772|NCT01152463|"     Lung cancer remains the leading cause of mortality from malignant diseases in both men and     women worldwide. Following thoracic surgery and pulmonary resection, patients have a     surgically induced pneumothorax / hydro-hemothorax and hence tube thoracostomy is necessary     to drain the air and effusion. Due to this, patients must undergo post-operative chest x-ray     (CXR) evaluations in order to evaluate the chest and make decisions regarding removal of     chest tubes (CT) as well as for decisions regarding patient discharge. Thoracic Ultrasound     (US) has been shown to be accurate at diagnosing pneumothorax and has been well-studied in     the trauma population. To the investigators knowledge, there are currently no centers using     thoracic US routinely in the post-operative setting following thoracic surgery.   "
251773|NCT01152476|"     Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused     more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%.     Therefore, lower minimum alveolar concentration of sevoflurane will reduce the EA when it is     used with remifentanil in pediatric general anesthesia.   "
251774|NCT01152489|"     The hypothesis of this study is that distraction cards used by the caretaker along with a     vibrating cold pack placed proximal to the site of immunization will decrease the pain of     routine pediatric immunizations when compared to a placebo device or standard care.   "
251775|NCT01152502|"     Follow-up of urinary concentration from paracetamol metabolites by patients with aortic     surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)   "
251776|NCT01152515|"     Tracheal extubation can be associated with hyperdynamic circulatory response. The     investigators examined the effect of maintaining a remifentanil infusion on the     cardiovascular response during extubation in propofol-remifentanil sedated patients after     surgery.   "
251777|NCT01152528|"     The purpose of this study is to determine whether screening of pregnant women with history of     previous preterm delivery, once a week, for bacterial vaginosis using VA-SENSE, and treatment     of positive women will reduce the risk of spontaneous preterm birth. We will compare between     the effectiveness of once a week screening and once during pregnancy screening.   "
251778|NCT01152541|"     Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing     progression of both keratoconus and corneal ectasia after surgery, as well as possibly     decreasing the steepness of the cornea in these pathologies. During the CXL procedure, the     central corneal thickness has been shown to significantly change. The investigator's believe     that better maintenance of corneal thickness potentially could have benefits of better     reproducibility of the crosslinking effect with improved predictability of results.   "
251805|NCT01152892|"     The purpose of this study is to evaluate the use of non-invasive markers of the autonomic     function and micro- and macrocirculation to predict mortality and cardiovascular end points     in end-stage renal disease patients. Furthermore we aim at getting new insight into the     insufficiently understood pathophysiology leading to excessively high cardiovascular and     non-cardiovascular mortality in dialysis patients.   "
251781|NCT01152580|"     Osteoporosis is one of the most common skeletal disorders. Today in the United States, 10     million individuals have osteoporosis and 34 million more have low bone mass or osteopenia,     which places them at an increased risk of some day developing osteoporosis. Of the people     affected by this problem, 68% are women.The current thinking on the development of     osteoporosis is that the changes in bone turnover that occur with aging play a major factor.     Many modalities of treatment are used to prevent the bone loss and increased fracture risk     associated with osteoporosis and osteopenia. Melatonin supplementation may be another     treatment modality that lowers risk of hip fracture in perimenopausal women. Melatonin can     remodel bone in animal models and in culture. Melatonin works through melatonin receptors to     form osteoblasts from human mesenchymal stem cells and has been shown to inhibit osteoclast     activity in rodents. Melatonin levels have been correlated with modulating bone markers; low     nocturnal levels of melatonin correlate with in an increase in bone marker metabolism and     osteoporosis. It is been shown that women who have worked night-shifts for greater than 20     years have increased risk for wrist and hip fractures. Night-shift workers have lower     nocturnal melatonin levels than people who do not work the night-shift. The addition of     exogenous melatonin suppresses bone marker metabolism. In human stem cells taken from bone     marrow, melatonin increases the activity of bone-forming cells called osteoblasts. It is     hypothesized that melatonin will improve bone health, menopausal quality of life and sleep     compared to placebo in perimenopausal women. In particular, the investigators expect     perimenopausal women taking melatonin to show an improvement in overall bone health as     revealed by a reduction in bone marker turnover since bone resorption increases more so than     bone absorption in this population compared to those women taking placebo. We also expect     that perimenopausal women taking melatonin to have better control over their menopausal     symptoms, better quality of life and less sleep disturbances when compared to their placebo     controls since melatonin is known to modulate estrogen levels in the body and regulate sleep.     The data from these studies may provide novel and alternative uses for melatonin; in     particular its use for the prevention and/or treatment of osteoporosis.   "
251782|NCT01152593|"     The investigators believe that irradication of nose colonization of staphyloccocus aureus     will reduce the incidence of surgical site infections after cesarean section.   "
251783|NCT01152606|"     This is a single cohort observational safety study. All patients will be treated and     monitored according to the local clinical practice. No additional procedures/patient visits     in comparison with the usual clinical practice are planned for the study. Data will be     collected from centre's medical records for up to 5 years or death.   "
251784|NCT01152619|"     This multi-center, randomized, observer-blinded, placebo-controlled study will evaluate the     safety and tolerability of subcutaneous doses of RO4989991 in patients with allergic rhinitis     who are otherwise healthy. The anticipated time on study treatment is 2 weeks.   "
251785|NCT01152632|"     Selecting acupoints along meridians is the predominant principle in acupuncture treatment,     and it is also considered to ensure acupuncture efficacy. This experiment is to investigate     whether specific brain networks gradually come in formation in accordance with this kind of     acupoint selection methods.   "
251786|NCT01152645|"     A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy     in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint     is disease control and the secondary efficacy endpoints include antitumor effect (tumor     response), progression-free survival and overall survival. The pharmacokinetic profile and     the safety profile are also evaluated.   "
251787|NCT01152658|"     The objective of this clinical trial is to evaluate the impact and symptomatic efficacy of     platelets rich plasma (PRP \ PRGF) in the treatment of partial tears of supraspinatus tendon     of rotator cuff.      Speed of tendon healing of partial thickness tear of the supraspinatus tendon influenced by     local injection of platelets rich plasma   "
251788|NCT01152671|"     This randomized, double-blind, placebo-controlled study will assess the safety, tolerability     and pharmacokinetics of RO5024048. Japanese and Caucasian healthy volunteers will be     randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10     days.   "
251789|NCT01152684|"     The goal of The investigators community-based participatory research study is to identify the     nature and extent of complementary and alternative medicine (CAM) use among HIV-positive     Latinos on the San Diego/Tijuana border. CAM use among US Latinos living with HIV is     associated with delayed utilization of and poor adherence to antiretroviral therapies (ARVs)     that may exacerbate health disparities in HIV care access and health outcomes. This study     will lead to development of culturally-effective interventions to improve access and     adherence to HIV care in Latinos who face health disparities. The investigators hypothesis is     that greater use of CAM will be observed among HIV-positive Latinos who report a) crossing     the U.S. border more frequently, and b) having migrated to Tijuana or San Diego (e.g. from     southern Mexico). The investigators also hypothesize that compared to HIV-positive Latinos     who report using herbal CAM, those who do not use herbal CAM are more likely to be receiving     ARVs and report higher levels of adherence to ARVs; Compared to HIV-positive Latinos who do     not attend religious services regularly, those who attend religious services regularly are     more likely to be receiving ARV; Compared to HIV- positive Latinos who report experiencing     HIV related stigma, those who do not report experiencing HIV-related stigma are significantly     more likely to be receiving ARVs.   "
251790|NCT01152697|"     Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia     and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%.     Inadequate adherence is associated with poor outcomes such as relapse, homelessness,     hospitalization, and increased health care costs. Studies have shown a direct correlation     between non-adherence and rates of relapse in schizophrenia; on average, non-adherent     patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. A     major obstacle to good outcomes in the maintenance treatment of patients with severe mental     illness is difficulty with medication routines on an on-going basis. For this reason,     long-acting injectable antipsychotic medication is a particularly attractive treatment option     for populations with schizophrenia and schizoaffective disorder, although it is unlikely that     medication treatment alone is likely to modify long-term attitudes and behaviors.      This prospective study is a pilot analysis of a combined approach which merges a psychosocial     intervention to optimize treatment attitudes towards psychotropic medication (CAE) and     long-acting injectable antipsychotic medication (L) in recently homeless individuals with     schizophrenia or schizoaffective disorder who are known to have on-going difficulties with     treatment non-adherence. It is expected that this combined approach (CAE-L) will improve     illness outcomes among the most vulnerable of populations with schizophrenia or     schizoaffective disorder.   "
251791|NCT01152710|"     A Phase II study aimed to evaluate the efficacy and toxicity of preoperative     chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.   "
251792|NCT01152723|"     Single-dose pharmacokinetics with two new oral nicotine replacement products and Nicorette®     gum.   "
251793|NCT01152736|"     Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.   "
251794|NCT01152749|"     This study examines the bioequivalence between an oral nicotine replacement product and     Nicorette® gum.   "
251795|NCT01152762|"     Chronic Obstructive Pulmonary Disease (COPD) is a very important public health problem and     one of the most common lung diseases in the world, with repercussions on mortality and high     economic costs. The World Health Organization estimates that COPD is the fifth most common     disease in the world and the fourth leading cause of death. It is expected to grow in     prevalence and mortality over the coming decades; it is estimated that in 2020, it will be     the third most common cause of death worldwide.      Primary care is the main ambit in the management of these patients, in fact, it is where most     patients with COPD are visited. However, a high proportion of these patients only receive     chest physiotherapy treatment in hospitals, and the implementation of this kind of treatment     in primary care is still very uncommon.      Hypothesis: There is effectiveness on the quality of life and various predictive factors of     mortality (BODE index, six-minute walk distance, FEV1, dyspnea, and body mass index) and the     economic impact of a Standardized Respiratory Physiotherapy program conducted in Primary Care     (FREAP) in patients with moderate COPD at 6 months after its implementation.   "
251796|NCT01152775|"     This study will investigate the potential impact of arts-informed, technology-based patient     education material, and specifically, the role of multimedia imagery on patient     comprehension, perceived satisfaction, anxiety levels, and informed decision-making.   "
251797|NCT01152788|"     The purpose of this study is to find out what effects an experimental drug, called     interleukin 21 or rIL-21, will have on malignant melanoma and whether these effects look     promising compared to dacarbazine. In addition, this study will look at the side effects of     rIL-21, and some special blood tests will be done to check the level of rIL-21 in the blood.     This study will also look at previously removed melanoma tissue to determine which patients     might benefit most from this treatment.      This research is being done because currently there is no effective treatment for this type     of cancer.   "
251798|NCT01152801|"     This is an open-label, multi-center study to evaluate the safety of RAD001 in Chinese     patients with metastatic renal cell cancer who are intolerant of or have progressed despite     treatment with vascular endothelial growth factor (VEGF)-targeted therapies. All patients     will be treated with RAD001 10 mg daily until tumor progression (determined according to the     Response Evaluation Criteria In Solid Tumors (RECIST) Criteria), unacceptable toxicity, death     or discontinuation from the study for any other reason. At least 60 patients will be enrolled     in the study. Screening and baseline evaluations will be performed within 28 days of the date     when the patient signs the informed consent form. Baseline evaluations will be performed     within two weeks of the first dose of RAD001. Screening and baseline evaluations will be     performed to determine if patient meets all inclusion and exclusion criteria. All eligible     patients should be enrolled in the study and will receive the first dose of RAD001 (10 mg     daily) on Day 1, Cycle 1. Subsequently, patients will be asked to come to the clinic every     month to complete the protocol-specified evaluations. A treatment Cycle consists of 28 days.     After discontinuation of treatment with RAD001, patients will have a safety follow-up     performed 28 days after the last dose of RAD001. Patients must continue with survival     assessments which will be performed every 3 months from the last dose of RAD001 until up to 2     years after the last patient's first visit date.      An interim analysis focusing on safety data and a final analysis of all data are planned. All     patients still receiving the study drug at the time of the final analysis will be given the     option to continue treatment with RAD001 until the occurrence of unacceptable toxicity or     disease progression.   "
251799|NCT01152814|"     This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza     vaccine administered to elderly subjects   "
251800|NCT01152827|"     -  According to Martin F et al, AKT is highly phosphorylated in phenochromocytoma but not          in benign adrenocortical tumors.        -  In nonfunctioning carcinoid, the PI3K/AKT/mTOR pathway is activated.        -  Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on          mTOR inhibition by RAD001 have been conducted in pheochromocytoma or extra-adrenal          paraganglioma or non-functioning carcinoid.        -  So we design this phase II study of RAD001 in pheochromocytoma or extra-adrenal          paraganglioma or non-functioning carcinoid to evaluate the efficacy of RAD001 in this          orphan disease.   "
251801|NCT01152840|"     -  Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on          mTOR inhibition by RAD001 has been systematically conducted in adenoid cystic carcinoma.        -  In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response          to RAD001 (unpublished data).        -  So the investigators design this phase II study of RAD001 in adenoid cystic carcinoma to          evaluate the efficacy of RAD001 in this orphan disease.   "
251802|NCT01152853|"     In case of gastric cancer, the incidence of HER-2 positivity (2+, 3+ on IHC and/or FISH (+))     is reported as similar as that of breast cancer, that is 22% of all cases. A recent ToGA     Trial, phase III trial comparing trastuzumab combined with chemotherapy     (fluoropyrimidine+cisplatin) versus chemotherapy alone in chemotherapy-naïve HER-2 (+)     gastric cancer shows the significant benefit of using trastuzumab in terms of overall     survival and progression-free survival. It provides the clinical evidence of HER-2 as a     reasonable and potential therapeutic target in gastric cancer.      Nowadays, lapatinib, HER-1 and HER-2 dual inhibitor, is also testing under the clinical trial     in gastric cancer.      In preclinical study, PF-00299804 is highly active in HER-2 amplified gastric cancer cell     lines.(SNU preclinical data) So, we plan this phase II trial of PF-00299804 monotherapy in     patients with HER-2 positive advance gastric cancer after failure of at least one     chemotherapy regimen.   "
251803|NCT01152866|"     With the development of the recombinant gonadotrophins, the use of human source proteins for     the production of hormones has become unnecessary. These proteins, which are found in urinary     preparations, have been thought to cause the local, post-injection adverse events (AEs) in     some subjects.      There has been a demand by physicians for an alternative to urinary products for treatment.     Due to allergies to urinary products, or other personal reasons, subjects were not able or     willing to be treated with proteins of human origin. This study allowed subjects to be     treated with the recombinant human chorionic gonadotropin (r hCG) (free of urinary proteins),     which otherwise would not be possible. The study sponsor used this opportunity to collect     additional safety data on the new recombinant product, (Ovidrel, r-hCG).   "
251806|NCT01152905|"     Background: Recent studies have questioned our previous understanding on the effect of     nitrous oxide on muscle relaxants, since nitrous oxide has been shown to potentiate the     action of bolus doses of mivacurium, rocuronium and vecuronium. This study was aimed to     investigate the possible effect of nitrous oxide on the infusion requirements of     cisatracurium.      Methods: 70 ASA physical status I-III patients aged 18-75 years were enrolled in this     randomized trial. The patients were undergoing elective surgery requiring general anesthesia     with a duration of at least 90 minutes. Patients were randomized to receive propofol and     remifentanil by target controlled infusion in combination with either a mixture of oxygen and     nitrous oxide (Nitrous oxide/TIVA group) or oxygen in air (Air/TIVA group). A 0.1 mg/kg     initial bolus of cisatracurium was administered before tracheal intubation, followed by a     closed-loop computer controlled infusion of cisatracurium to produce and maintain a 90%     neuromuscular block. Cumulative dose requirements of cisatracurium during the 90-min study     period after bolus administration were measured and the asymptotic steady state rate of     infusion to produce a constant 90% block was determined by applying nonlinear curve fitting     to the data on the cumulative dose requirement during the study period.      Results: Controller performance, i.e. the ability of the controller to maintain neuromuscular     block constant at the setpoint and patient characteristics were similar in both groups. The     administration of nitrous oxide did not affect cisatracurium infusion requirements. The mean     steady-state rates of infusion were 0.072 +/- 0.018 and 0.066 +/- 0.017 mg * kg-1 * h-1 in     Air/TIVA and Nitrous oxide/TIVA groups, respectively.      Conclusions: Nitrous oxide does not affect the infusion requirements of cisatracurium.   "
251807|NCT01152918|"     This is a five-part study that will take place in the Bronx, NY, and Washington, D.C. The     different components of the study will focus on increasing the number of people being tested     for HIV, evaluating ways to link HIV-infected people to HIV care sites, evaluating methods to     reinforce antiretroviral therapy (ART) adherence, and evaluating a counseling program that     focuses on HIV prevention.   "
251808|NCT01152931|"     In the last decade, the prevalence of malaria has been escalating at an alarming rate,     especially in Africa. An estimated 300 to 500 million cases each year cause 1.5 to 2.7     million deaths, more than 90% occur in children under 5 years of age in Africa (WHO 1995).     Malaria is Africa's leading cause of under-five mortality (20%) and constitutes 10% of the     continent's overall disease burden. It accounts for 40% of public health expenditure, 30-50%     of inpatient admissions, and up to 50% of outpatient visits in areas with high malaria     transmission. Antioxidant micronutrients have immunomodulatory role and may have suppressive     activity.   "
251809|NCT01152944|"     The objective of this SAMMPRIS-affiliated study is to understand the mechanisms the     mechanisms that underlie ischemic stroke recurrence in high-grade intracranial     atherosclerotic disease in order to determine predictors of recurrent stroke. MoSIS will     evaluate 6 specific mechanisms of stroke in the medically-treated SAMMPRIS cohort: decreased     antegrade flow, progression of stenosis, decreased proximal collateral flow, decreased distal     collateral flow, impaired cerebrovascular reserve, and artery-to-artery embolism.   "
251810|NCT01152957|"     A study to examine the effectiveness of a multilevel Community Health Workers intervention as     an adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos in     Miami.   "
251811|NCT01152970|"     The provision of medical services in an inner city Emergency Department (ED) provides a     critical opportunity to identify and characterize future timing and pattern of service use     among youth with drug use, who may be missed in school-based samples, and who may not yet be     in the criminal justice system. Currently, there is a paucity of data on the timing, pattern,     barriers, and trajectory of youth with multiple risks (illicit drug use and ED visit for     acute violence related injury) in terms of their intersection with health services (substance     use treatment, mental health, medical) and criminal justice system, which limits the     development of optimal timing and setting for interventions. Youth treated in the ED may have     exacerbated rates of illicit drug use, and other risk behaviors (i.e. delinquency, HIV risk     behaviors, weapon carriage) and different trajectories of outcomes and interactions with     service use sectors based on presentation for intentional injury as compared to other     complaints (medical, unintentional injuries). Understanding the outcomes and service     utilization among inner-city youth with drug use with and without acute violent injury is     critically important in developing prevention and treatment services to address these     multiple risk factors. The investigators propose a prospective observational study over a     two-year period to identify a high risk group of youth with past year illicit drug use     (N=650) seeking care in an inner city ED. The specific aims of the study, chosen to obtain     data necessary to determine the location and content of subsequent interventions, are: (1) To     describe characteristics of youth (ages 14-24; n=650) who report illicit drug use presenting     to an urban ED for an acute violent injury (n=350), compared to youth with drug use who seek     non-violence related ED care (n=300), including demographic characteristics, problem severity     (e.g., substance use, violence, HIV risk behaviors, etc.), enabling factors, and service     utilization (i.e., substance use treatment, mental health, and medical); (2) To identify the     trajectories of participants' interactions with health services during the two years     following their ED visit and the key characteristics (i.e., predisposing, enabling, and need     factors) associated with types of service use (substance abuse treatment, mental health, and     medical/ ED) and barriers to these services; and, (3) To measure two-year outcomes for this     cohort and to identify key demographic and clinical characteristics of youth with drug use,     who have poor outcomes in the two years after ED visit for intentional injury and other     medical care.   "
251812|NCT01152983|"     The purpose of this study is to demonstrate the safety, performance and initial efficacy of     the RapiDx device.   "
251813|NCT01152996|"     The purpose of this study is to determine the long-term safety and tolerability of     vortioxetine, once daily (QD), in participants with major depressive disorder.   "
251814|NCT01153009|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of     vortioxetine, once daily (QD), compared with placebo in adults with major depressive     disorder.   "
251839|NCT01153360|"     This study is planned to medicate oral T3(Liothyronine)to the patients who are planned to     have OPCAB(off- pump coronary bypass graft surgery. The aim of this study was to assess the     effects of oral triiodothyronine (T3) therapy on postoperative thyroid hormone     concentrations, hemodynamic variables and outcomes in patients undergoing OPCAB in a     randomized, controlled trial.   "
251868|NCT01153737|"     This study investigated effectiveness of manual therapy (MT) with Electric Nerve Stimulation     (TENS) to reduce pain intensity in patients with mechanical neck disorder (MND). A randomized     multi-centered controlled clinical trial was performed in 12 Primary Care Physiotherapy Units     in Madrid Region.   "
251869|NCT01153750|"     To test the efficacy of a combination chemotherapy of imatinib and 5-FU in advanced or     metastatic cholangiocellular carcinoma.   "
251870|NCT01153763|"     BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and     tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF     mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and     continue on treatment until disease progression, death, or unacceptable adverse event.   "
251815|NCT01153022|"     Objective: To determine the effect of ankle joint mobilization on the alpha motoneuron reflex     excitability of the soleus muscle in people with spasticity.      Subjects and Methods: A controlled clinical trial with crossover design and simple masking     was conducted in 24 randomized subjects to initiate the control or experimental group.     Traction and rhythmic oscillation were applied for five minutes to the ankle joint. Alpha     motoneuron reflex excitability was assessed by measuring H wave amplitude (Hoffmann reflex -     H reflex), stimulating the tibial nerve at the level of the popliteal fossa and recording in     the soleus muscle. In each subject 12 measurements were taken: basal rate, during and after     mobilization. Changes in alpha motoneuron reflex excitability were calculated in relation to     basal measurement. For each measurement a hypothesis test was performed (Student t test).      Results: In groups of patients with brain injury (BI) and incomplete spinal cord injury     (ISCI), a significant difference was found between measurements of both studies, concerning     variation in alpha motoneuron reflex excitability during the application of joint     mobilization techniques, with a decrease in the experimental group and an increase in the     control group. In contrast, no significant differences were found after mobilization therapy.     Patients with complete spinal cord injury (CSCI) showed no significant differences in any     measurements.      Conclusion: We demonstrate the effectiveness of passive movement in the decrease of muscle     tone during the mobilization maneuver in patients with BI or ISCI, but no residual effect     after completion of the trial. This research project showed no evidence regarding spasticity     reduction in complete spinal cord injuries. This suggests that therapeutic interventions to     decrease muscle tone, based on the passive exercise and stimulation of proprioceptors should     be reconsidered.   "
251817|NCT01153048|"     The main objective is to assess impact of the establishment of involved patients (peer     educators) network in Mali. It will be conducted by a multidisciplinary team that brings     together high level skills in research projects and in peer education projects. It will be     conducted in one country Mali. In the country, it will be completed in one site : the region     of Sikasso. This site was chosen because It meet a functional care, access to medicines and a     dynamic association of diabetic patients. Peer educators and persons targeted by the project     will be recruited through Post-Test Club on diabetes (PTC). PTC will be a social support club     that provides on going prevention counseling, education and support services to people who     have diabetes. PTC represents an important link between patients, educators and general     medical services. PTC will be defined as clubs, which are facilitated by well-trained peer     educators, and will have 3 objectives: to provide social and emotional support to diabetic     patients, to provide assistance in daily management and living with diabetes and to provide     linkage to clinical care. To lead the sessions, in clubs, we will use a very innovative     methodology for peer education: the learning nests method. To evaluate, we propose a     classical randomized controlled experimental (RCT) design, with randomization at the     person-level. For outcome measures, we propose change in HbA1c, increase of social and     emotional support and increase of linkage to clinical care. In addition to HbA1c, we propose     measuring changes systolic and diastolic blood pressure and weight.   "
251818|NCT01153061|"     Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac     septal defects.   "
251819|NCT01153074|"     The purpose of this study is to evaluate the feasibility of closing bronchopleural fistulas     with devices originally developed for correction of cardiac septal defects deployed through     bronchoscopic procedures.   "
251820|NCT01153100|"     The investigators anticipate that the use of Glargine will decrease the duration of an     insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care     unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the     insulin drip is discontinued.   "
251821|NCT01153113|"     The purpose of this research is to develop a new and powerful type of immune therapy for     prostate cancer patients. This therapy involves vaccinations with special stimulator cells     found in the human body called dendritic cells. These dendritic cells can take up proteins     released from cancer cells and present pieces of these proteins to immune cells called T     lymphocytes to create a strong stimulatory signal to fight the cancer.      One of these proteins is called telomerase, which is found on prostate cancers and is     critically important for prostate cancer cells to grow. However, in most cancer patients, the     immune system does not adequately destroy the tumor because the T cells are not stimulated     sufficiently. T cells require strong stimulation before they grow and become active against     cancer cells.      We have discovered that substances called ribonucleic acids (RNA), which carry the genetic     instructions for the production of telomerase, can be used to overcome this problem and     stimulate a strong immune response in cancer patients.      In order to test this hypothesis we have designed a clinical study and will enroll patients     with metastatic prostate cancer expressing telomerase in order to determine whether or not     this vaccine will stimulate T cells, which can recognize and kill prostate tumor cells.      The main objectives of this study are to find out whether injections with dendritic cells     grown from blood cells and pulsed (mixed together for a short period of time) with RNA     derived from the patient's own tumor are:        1. Safe without inducing any major side effects.        2. And effective in boosting the patient body's immunity against telomerase expressing          prostate cancer cells.        3. Finally, we will test whether or not tumor shrinkage based on serum PSA levels or on          X-ray studies will occur.      We hope that this new form of immune therapy, although in its infancy, will ultimately slow     down tumor growth and prolong survival of prostate cancer patients.   "
251822|NCT01153126|"     This project evaluates the impact of CHESS-Mammo by assessing participants' health     information competence, psychological distress, and satisfaction with their doctor as     measured by previously validated survey questionnaires.   "
251823|NCT01153139|"     Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the     treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may     exert larger effects.      This sham-controlled study examines the effectivity of daily bilateral TBS to the     dorsolateral frontal cortex over 6 weeks in 2x16 patients with major depression add on to the     local standard of a combined pharmacological/psychotherapeutical treatment.   "
251824|NCT01153152|"     The purpose of this study is to determine whether pulp chamber opening and drainage on wisdom     teeth with acute pulpitis before the extraction could reduce postoperative pain so beneficial     to patient.   "
251825|NCT01153165|"     Purpose and design: The relationship between psychological morbidity and asthma has been     previously recognised, however there is little evidence regarding the link between poor     mental health and asthma control in people with severe asthma. If evidence was available     showing that identifying and treating depression, resulted in meaningful improvements in     people's asthma symptoms, this would be helpful in changing doctors' approach to people with     severe asthma, ensuring that both physical and mental wellbeing were considered.      This study will be a double blind randomised placebo controlled pilot study which aims to     identify; if treating depression in patients with well characterised refractory asthma     improves depression and asthma control. Forty patients who meet the inclusion criteria will     be randomised to either a placebo or anti-depressant medication group, neither the     participant nor the researcher will be aware of which medication they are given. Patients     recruited will have severe asthma; will be identified as having depression using two     validated questionnaires and will agree to take part and to take anti-depressant medication.     Patients with poor adherence to medication, other respiratory conditions and who have had     anti-depressant medication in previous the 6 months will be excluded. Outcome measures such     as depression questionnaires, quality of life questionnaire, lung function, measures of     airways inflammation and reduction in dose of oral steroids will be used to determine the     effect of anti-depressant medication on depression and asthma control. The treatment period     will be 12 weeks with outcomes assessed in the first and final week of treatment. The     investigators hope to find out if the study protocol we have devised is feasible for a larger     multi-Centre clinical trial and demonstrate some evidence that treating depression in     subjects with well characterised refractory asthma will improve depression and asthma symptom     control (this will be used to estimate the size of a larger clinical trial).      Recruitment: Participants will be identified and approached by a member of their usual     healthcare team and invited to participate. Participants will be given time to consider     whether they wish to take part and will assured that their care will be unaffected should     they choose not to participate or to withdraw during the study period.      Inclusion/exclusion: All patients will be assessed using our well established systematic     evaluation protocol. Refractory asthma will be based on the definition of the American     Thoracic Society Consensus Workshop. Patients recruited will have refractory asthma, will be     identified as having depression using two validated questionnaires and will agree to take     part and to take anti-depressant medication. Patients with poor adherence to medication,     other respiratory conditions and who have had anti-depressant medication in previous the 6     months will be excluded.      Consent: People who are unable to give informed consent will be excluded from the study as     they may be particularly vulnerable. Capacity to give informed consent will be assessed by     the participant's usual healthcare professionals.      Risks, burdens and benefits      There is a small risk of agitation and suicidal ideation associated with commencement of     selective serotonin reuptake inhibition (SSRI) anti-depressants. The investigators will     attempt to minimise this risk by:        1. Contacting participants 1 week after commencing treatment and 1 week after any          subsequent dose increase to ensure there is no suggestion of agitation or suicidal          ideation. This is in accordance with the guidelines for initiation of SSRI therapy in          adults.        2. Participants will also be contacted weekly for 2 weeks after discontinuation of study          treatment. If depressive symptoms worsen patients will be advised to liaise with their          GP to consider institution of treatment on clinical grounds.   "
251826|NCT01153191|"     The purpose of this study is to evaluate two different simple and inexpensive extra     treatments during colorectal surgeries to see if this will reduce the rate of post operative     infections   "
251863|NCT01153672|"     This pilot clinical trial studies vorinostat in treating patients with stage IV breast cancer     receiving aromatase inhibitor (AI) therapy. Vorinostat may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Vorinostat may also help AI therapy work     better by making tumor cells more sensitive to the drug   "
251864|NCT01153685|"     This study is designed to test the safety and immunogenicity of Fluviral® (2010 - 2011     Season) in adults aged 18 to 60 years and over 60 years.   "
251871|NCT01153776|"     The purpose of this study is to find a non-invasive alternative (with using ECG gated     64-slice CT angiography) to invasive coronary angiography for detecting coronary lesions in     patients who had undergone arterial switch operation for transposition of the great arteries   "
252106|NCT01157013|"     Positron emission tomography (PET) with [18F]fluorodeoxyglucose (FDG-PET) evaluates cancer     cell glycolysis(Warburg effect) as a surrogate for tumor response.The hypothesis of this     study is that early changes in FDG-PET signal can predict sorafenib response in     hepatocellular carcinoma (HCC).   "
251827|NCT01153204|"     Context and Objectives: Erectile dysfunction severely compromises not only sexual     satisfaction, which is well known to be closely linked to overall life satisfaction but is     also associated with a lower quality of life, lower self-esteem, depression, anxiety and     adverse effects on interpersonal relationships. The objective was to assess the efficacy of     psychotherapy and/or sildenafil for psychogenic erectile dysfunction.      Design and Settings: randomized controlled single-blind trial performed at Institute of     Psychiatry of the Medical School of at Universidade de São Paulo, São Paulo, Brazil Methods:     Thirty patients with mild and moderate psychogenic erectile dysfunction (ED) were randomized     to receive for six months: group psychotherapy (GP) plus 50mg sildenafil on demand, or 50mg     sildenafil exclusively, on demand, or GP exclusively. Changes in score from baseline for     three questions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) were     evaluated at end-point and after 3-months follow-up.      Results: satisfaction with the treatment, confidence and naturalness increased in GP plus     sildenafil and GP exclusively groups (p=0.001) from baseline to endpoint. The     treatment-by-time comparison was not significant at end point versus 3-month follow-ups, in     the three groups. No difference was observed in the sildenafil group in the three study     periods (P >0.05) Conclusions: Patients with mild and moderate psychogenic ED had higher     treatment satisfaction, confidence and naturalness in engaging in sexual activity when     receiving GP plus sildenafil or GP exclusively, when compared with sildenafil exclusively, as     assessed by these three EDITS questions after 6-months treatment   "
251828|NCT01153217|"     Most of studies have not found any consistent drug-specific association with bone loss and     controversial data with respect the effect of protease inhibitors (PIs) have been published.     The more evident finding with respect to this issue is the more pronounced decrease of bone     mineral density (BMD) in patients during the first weeks of receiving a tenofovir     (TDF)-containing regimen, probably by the effect of TDF on phosphorus balance and vitamin D     metabolism.   "
251829|NCT01153230|"     The purpose of this study is to determine frequencies of histo-pathological findings in dead     poisoned patients and evaluate their relationships with age, gender, dosage of poisoning,     time of admission and time of death.   "
251830|NCT01153243|"     Recent clinical trials in non diabetics showed that vitamin D supplementation markedly     reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix     metallo-proteinases. Our study objective is to evaluate if administration of vitamin D in     African Americans with hypovitaminosis D and DM Type 2 decreases serum levels of     inflammatory/thrombotic markers such as CRP: Highly Sensitive C Reactive Protein.   "
251831|NCT01153256|"     Magnesium had an inhibitory effect on neuromuscular transmission and caused a decrease in     muscle fiber membrane excitability. It reduces the amount of acetylcholine that is released     at the motor nerve terminal by decreasing the calcium conductance of presynaptic     voltage-dependent calcium channels. After pre-treatment with magnesium, an increased speed of     onset and a prolongation of the recovery period of neuromuscular blockade have been observed     with other non-depolarizing neuromuscular blocking agent (NMBA) such as atracurium,     vecuronium and rocuronium. Rocuronium is the currently preferred NMBA used as an alternative     to succinylcholine for rapid tracheal intubation. As an alternative to succinylcholine, high     doses of NMBA have been tested for rapid sequence intubation. This excessively high dose of     rocuronium, however, prolongs the duration of the neuromuscular block and this may not be     warranted in every surgical setting.      The reduction of onset time of rocuronium by magnesium pre-treatment can make intubation     condition more rapid and much better clinically. It will thus be interesting to compare     intubation conditions of a standard intubation dose of rocuronium after magnesium     pre-treatment with high dose of rocuronium or standard dose of rocuronium.   "
251832|NCT01153269|"     The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human     Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus     co-infected patients.   "
251833|NCT01153282|"     Determine the characteristics of symptoms and functional impairment associated with     chemotherapy induced peripheral neuropathy.   "
251834|NCT01153295|"     The study aims to investigate how to give the diagnosis of Irritable Bowel Syndrome.      The investigators compare two parallel groups of primary care patients, in the age of 18-50     years with gastrointestinal complaints where the GP suspects IBS. All included patients     fulfil international diagnostic criteria (ROME III) and have no danger signals.      Group 1: The diagnosis is based on the diagnostic criteria and few blod tests Group 2: The     diagnosis is a diagnosis of exclusion after investigations with extended blod tests,     examination for milk- and gluten intolerance, stoll for ova and parasites and scopy of the     intestine.      After receiving the diagnosis of Irritable bowel syndrome all patients are informed about the     condition.      The investigators follow the patients for 1 year. The investigators hypothesis is that the     two investigation programmes (group 1 and 2)are equal with respect to the patients´ quality     of life, symptoms and satisfaction and also with respect to finding of organic diseases.   "
251835|NCT01153308|"     The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of     bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric     bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity     and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular     disease.   "
251836|NCT01153321|"     The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of     patients with mild COPD.   "
251837|NCT01153334|"     Objectives: An investigator-initiated, double-blind, randomized, placebo-controlled,     multi-center study to evaluate the efficacy of early intensive rosuvastatin therapy     (rosuvastatin 40 mg for pre-PCI loading and 7 days post PCI and 10 mg daily thereafter)     versus low dose conventional statin therapy (placebo for pre-PCI loading and rosuvastatin 10     mg daily after primary PCI) on infarct size measured by cardiac MRI and clinical outcomes in     STEMI patients undergoing primary percutaneous coronary intervention (PCI). Hypothesis: The     infarct size in the early high dose rosuvastatin group is smaller than that of the control     patients treated with low does conventional statin therapy.   "
251838|NCT01153347|"     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like     medicine tablet or capsule, but contains no active medicine) is safe and effective when taken     together with another antidepressant.   "
251840|NCT01153373|"     The investigators study will use a randomized controlled design. Eligible and consenting     participants will be randomly assigned to one of two conditions: (1) DARSSA Intervention     condition, or (2) Minimal Intervention Control condition. All enrolled participants will     undergo the DARSSA baseline assessment and will be interviewed immediately following their ED     discharge to assess relevant outcomes, such as whether they were asked about substance use     and given a referral during their visit. This is referred to as the post-visit interview. All     risky substance users enrolled during all phases will be interviewed again at 1- and 3-months     post-visit to assess substance use, treatment engagement, and other outcomes. The primary     difference between the two conditions is that, for the DARSSA Intervention condition, the     subjects will have their reports printed and will be given the option of receiving the     dynamic referral, while for the Minimal Intervention Control condition the subjects will     undergo the assessment and will receive the standard substance abuse treatment referral list     currently in use clinically at each site. The number of assessments and interactions with     research staff will remain equal between the two conditions, with the only difference being     the active intervention of the DARSSA reports and referrals, and any counseling by healthcare     providers this engenders. The remainder of this section describes each phase of the study and     enrollment procedures.   "
251841|NCT01153386|"     This study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5     mg treprostinil diethanolamine tablet strengths in healthy volunteers.   "
251842|NCT01153399|"     The primary objective of the study is to collect epidemiological data on EGFR mutation status     [M+(mutation positive), M-(mutation negative)] in a population of predominantly Caucasian     ethnicity, and to correlate EGFR mutation status with clinico-pathological characteristics     (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine     the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics     that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and     non-adenocarcinoma).   "
251843|NCT01153412|"     Postural stability and balance are defined as the body's ability to return the body back to     its equilibrium point when exposed to a perturbation. This exploratory project is based on     the hypotheses that decreased balance (increased sway as measured by the center of pressure     of the body during quiet standing) causes an increased risk of falls and osteopathic     manipulative treatment can improve postural balance. To test these hypotheses, the     investigators will investigate the kinematics (study of the way the body moves) of postural     balance in two cohorts of healthy elders, those receiving manipulation and those not     receiving manipulation. We hypothesize that OMT is effective to increase postural stability,     balance.   "
251844|NCT01153425|"     The purpose of this study is to apply a novel advanced magnetic resonance imaging methodology     to evaluate the response to drug intervention involving two treatment arms of postmenopausal     participants with osteoporosis, randomized into either a teriparatide (Forteo™) or zoledronic     acid (Reclast™) group.   "
251845|NCT01153438|"     The purpose of this study is to see how hormones that control blood sugar change in response     to two different weight loss surgeries (gastric bypass and gastric banding). We believe that     changes in a hormone called glucagon-like peptide-1 (GLP-1) may account for the greater     improvement in blood sugar after certain types of surgeries. GLP-1 makes the pancreas release     insulin, a hormone that lowers blood sugar. The study will consist of one screening visit and     three study visits in which the glucose response will be measured after drinking a liquid     meal: 1) Visit 1 (2-3 weeks before surgery); 2) Visit 2 (after 10% of body weight is lost);     and 3) Visit 3 (5-10 days after Visit 2). Hormone levels will be measured during the three     study visits. To see if the improvement in blood sugar after surgery is due to changes in     GLP-1, we will block its effect on insulin release by giving either salt water or a     medication that blocks the activity of GLP-1 during the two visits that take place after     surgery (Visits 2 and 3).   "
251846|NCT01153451|"     Specific Aims: (Study #1, funded by AHRQ, completed May 2011)        1. To create an automatic notification system to prompt physicians of test results          finalized after discharge.        2. To evaluate the impact of this system on physician awareness of test results finalized          after discharge.      Hypothesis: Automatic email notification will improve physician awareness of test results     finalized after discharge compared to usual care.      Specific Aims: (Study #2, funded by CRICO, completed July 2012)        1. To identify a cohort of discharged patients with potentially actionable results of tests          pending at discharge (TPAD).        2. To determine if automated email notification of the finalized results of potentially          actionable TPADs affects the rate of post-discharge actions taken as documented in the          electronic medical record (EMR).      Hypothesis: Automated email notification of the finalized results of potentially actionable     TPADs increases the rate of actions taken post-discharge.   "
251847|NCT01153464|"     This protocol (a supplement to 805466) is to test whether our telephone continuing care model     can be implemented successfully by real world publicly funded programs. Participants will     be recruited from Philadelphia's Department of Behavioral Health - run drug programs. The     investigators will train city telephone care managers to deliver our telephone continuing     care intervention to patients in this program. The investigators will randomize 200 to     receive this intervention or usual care and follow them for 12 months.   "
251848|NCT01153477|"     The purpose of this challenge grant is to conduct an initial test of a new, enhanced version     of this protocol (telephone monitoring and counseling - enhanced, or TMAC-E), which has been     modified to include the elements of our existing continuing care intervention plus     patient-centered changes to boost patient involvement and community linkages. The     investigators will recruit 150 cocaine dependent patients in publicly funded, community-based     programs and randomize them to treatment as usual or the TMAC-E and follow them for 12     months.   "
251865|NCT01153698|"     an open, prospective, observational study to collect data on safety (major bleeding events)     and efficacy (symptomatic venous thromboembolism(VTE)) of a switch from Enoxaparin to     dabigatran etexilate in patients with total knee replacement (TKR) and total hip replacement     (THR)   "
251866|NCT01153711|"     This clinical trial is intended to investigate a possible effect of the p-gp inhibitor     ketoconazole on the bioavailability of olodaterol   "
251867|NCT01153724|"     This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor     fluconazole on the bioavailability of olodaterol   "
251849|NCT01153490|"     Cannabis is the most used illicit substance in the United States. Previous studies suggest     that atypical antipsychotics decrease the frequency and the amount of substance use in     subjects with and without psychotic illness. So far, there are no controlled studies     assessing the effectiveness of atypical antipsychotics for decreasing cannabis and other     substance use in individuals with cannabis use disorders. The investigators postulate that     the atypical antipsychotic quetiapine ER is an effective agent for improving substance use     outcomes in subjects with cannabis use disorders. In this pilot study, the investigators will     test this hypothesis in heavy cannabis users (i.e., individuals who are cannabis dependent     and smoke three times or more per week). Because 50% of these heavy cannabis users report     histories of psychotic experiences (i.e., attenuated positive symptoms) while smoking and are     at risk for recurring psychotic symptoms, the investigators will focus this pilot clinical     trial on this subgroup of cannabis users in order to increase the risk/benefit ratio of this     study and target a population that may also benefit from the antipsychotic effect of     quetiapine ER. Considering the lack of controlled studies assessing the efficacy of atypical     antipsychotics in heavy cannabis users, assessing the effectiveness of an atypical     antipsychotic medication on substance use and clinical outcomes in this population is     critical for improving the prognosis of these individuals.      Thus, the aims of this randomized, double-blind, placebo-controlled study are to assess the     efficacy of an atypical antipsychotic (quetiapine ER) in 120 subjects with cannabis     dependence, a recent history (within a year) of attenuated psychotic symptoms, and using     cannabis 3 times or more per week for: (1) decreasing the use of cannabis and other     substances; and (2) preventing the recurrence of psychotic experiences. The investigators     will also assess the effects of quetiapine ER on craving and mood, and its tolerability. This     project will be a 12-week, randomized, double-blind, placebo-controlled study with quetiapine     ER and it will include a comprehensive assessment of symptoms, substance use, and side     effects.      This study will benefit the field by providing unique data on the relative efficacy and     tolerability of treatment with atypical antipsychotics in heavy cannabis users with a     vulnerability to psychosis. This study will be the basis for future studies assessing the     long-term efficacy and tolerability of atypical antipsychotics in individuals with cannabis     use disorders.   "
251850|NCT01153503|"     In this randomized, controlled, observer-blinded study we plan to evaluate ultrasound-guided     transversus abdominis plane (TAP) block for postoperative pain management in patients     undergoing abdominal hysterectomy.   "
251851|NCT01153516|"     The purpose of this study is to evaluate the mechanisms leading to rapid postoperative     improvement in diabetes following Gastric By-Pass surgery for obesity.We will evaluate and     compare the changes in glucose level, beta-cell function, and insulin resistance induced by a     week of very low calorie liquid diet and those induced by a week of matched very -low calorie     liquid diet occuring in the context of routine postoperative care following RYGB.   "
251852|NCT01153529|"     The long-term goal of this research project is to identify genes that contribute to or guard     against developing posttraumatic stress disorder (PTSD) and to better understand how genes     and life experiences work together to impact PTSD. Inherited traits are passed down from one     generation to the next in genes. Genes contain molecules called DNA, which contain the     information that determines our characteristics and carries instructions for constructing and     operating our body. Most human diseases have an inherited element. In addition, we, the     investigators, hope to learn about how genes and the other materials we find in participants'     blood relate to other illnesses and behaviors.      The goal of the feasibility project covered by this application is to test the possibility of     conducting research on a large number of veterans in order to look at the association between     genes and PTSD. We are inviting 1,000 OEF/OIF veterans to participate, of these, we are     anticipating approximately 250 veterans who have served in Afghanistan and/or Iraq to     participate in this study. Although 250 participants is our target enrollment, we plan to     enroll all veterans included in our initial mailings who desire to participate. We do not     anticipate this to exceed 500 individuals. This phase of the study is expected to last about     one year. Specific aims are: 1. evaluation of sampling methods and participation rates; 2.     field testing of assessment batteries including reliability and validity; and 3. evaluation     of the proposed DNA collection and storage procedures.   "
251853|NCT01153542|"     The objective of this study is to evaluate the effects of VX-770 on Desipramine   "
251854|NCT01153555|"     This is a multi-center, prospective registry of patients with intermediate coronary lesions     defined as a stenosis of 40-80% by angiography. Approximately 300 patients will be enrolled     into the study at sites in the United States and Europe. There will be no follow up beyond     hospital discharge in this study. A sub-group of 30 patients will undergo Adenosine MRI. The     investigators hypothesize that Intravascular Ultrasound Radiofrequency (IVUS RF) anatomical     criteria, such as minimal luminal area, plaque burden and virtual histology plaque type, can     predict physiological ischemia by Fractional Flow Reserve (FFR).   "
251855|NCT01153568|"     Vitamin D is a hormone that is produced when sunlight is absorbed by the skin. Vitamin D     insufficiency has been recognized as a problem in areas where sun exposure is limited,     especially in the wintertime. In addition, the more pigmented the skin is, the less capable     it is of utilizing sunlight to make vitamin D. Vitamin D plays an important role in helping     the body absorb calcium and in building strong bones. It has also been shown to improve     muscle function in the elderly. As we get older, our vitamin D levels in the blood go down     and this may increase the risk for falls and fractures. If we can improve vitamin D status as     we age, we may be able to improve muscle strength and decrease the risk of falls and     fractures.   "
251856|NCT01153581|"     This study is designed to determine the causes of orthostatic intolerance which occurs more     commonly in women than in men. Orthostatic tolerance is the ability to remain standing up     right for long periods of time, or to avoid dizziness when moving to standing from a seated     or lying position.   "
251857|NCT01153594|"     The objective of this study was to evaluate the relative effectiveness of quarterly Recovery     Management Checkups (RMC) on long-term outcomes of adult chronic substance users over 4     years.   "
251858|NCT01153607|"     PET (positron emission tomography) imaging with BAY1006578 for investigation of diagnostic     potential in probable Alzheimer Disease patients versus healthy volunteers and radiation     dosimetry in healthy volunteers.   "
251859|NCT01153620|"     The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04%     when used as an antiseptic agent and to compare these with Ringers' solution in patients with     acute traumatic wounds.   "
251860|NCT01153633|"     The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation     Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared     to control saline irrigation solution and inactive gel by showing a reduction in size over a     12 week period.   "
251861|NCT01153646|"     This is a pilot study to determine the safety and feasibility of lentivirus-transduced T-cell     immunotherapy in patients who have failed highly active anti-retrovirus therapy (HAART).   "
251862|NCT01153659|"     This will be a randomized, open-label, single-center, 3-way crossover study in healthy     subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will     consist of 3 study periods separated by a washout period of at least 7 days. Subjects will     receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be     discharged from the study on Day 6 of Period 3 after completion of discharge procedures.   "
251872|NCT01153789|"     The eye movements of vergence allow binocular vision whatever the viewing distance or the     body movements are and the perception of depth. Vergence dysfunction can lead to erroneous     visual sensation of movements. In our daily life using screens (computer, game boys..) is     increasing and this approach heavily the ocular vergence and can lead to symptoms if     oculomotor and accommodative systems are dysfunctioning (Ped. Neurology 2000). Not knowing     this pathology lead to inappropriate and expensive prescription CT scan or NMR. To evaluate     the vergence performances just evaluation in static condition is currently available in     ophthalmology departments. The CNRS laboratory (IRIS, FRE 3154) adapted a technic of eye     movement recording to study ocular vergence in dynamic condition.   "
251873|NCT01153802|"     GSK1360707 is a potent re-uptake inhibitor of the neurotransmitters dopamine, norepinephrine     and serotonin. This is a single dose PET study in healthy subjects.A final analyses of safety     data following exposure to single oral doses, from the first time in human study, with     GSK1360707 has demonstrated that the compound is well tolerated up to a dose of 150mg. This     imaging study will be an open label, non-randomised PET occupancy study using healthy male     volunteers. The degree and time course of DAT and SERT occupancy by GSK1360707 will be     determined. The PK/PD relationship between plasma concentrations of GSK1360707 and DAT and     SERT occupancy will be described.This protocol amendment includes the flexibility to split     the total dose into two doses e.g. 120mg per day could be split into two doses of 60mg.     Splitting the total dose is most likely required to maintain therapeutic occupancy on the     transporters over the course of the day; in addition it is expected that splitting the dose     may reduce effects on vital signs. Therefore collecting data following split dosing will     enable best predictions of therapeutic doses to be progressed in subsequent clinical studies.   "
251874|NCT01153815|"     This trial is a multicenter, double-blind, randomized, placebo-controlled study to compare     GSK1358820 (Botulinum Toxin Type A, also known as OnabotulinumtoxinA or Botox) with     placebo on the efficacy and safety of treatment in poststroke subjects with focal wrist,     finger and in some cases, thumb spasticity. Approximately 168 subjects will be enrolled.     Subjects will receive a single treatment session of intramuscular GSK1358820 (Botulinum Toxin     Type A, also known as OnabotulinumtoxinA or Botox) '200U or 240U (if thumb spasticity is     present)' or placebo in a randomization ratio of 1:1. The subjects will be observed until 12     weeks post injection. Outcome measures include changes from baseline at every post injection     visit as measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and     Global Assessment Scale. The primary efficacy endpoint is the change from baseline at week 6     for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters     will also be measured including adverse events, vital signs (pulse and blood pressure) and     clinical laboratory tests (haematology, serum chemistry and urinanalysis).   "
251875|NCT01153828|"     Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical     antibiotics approved for human use. In the European Union (EU), retapamulin is approved for     the treatment of impetigo and secondarily-infected traumatic lesions in persons nine or more     months of age. This study is designed to examine retapamulin use in the pediatric population     less than nine months of age. We will conduct a five-year assessment of prescriptions for     retapamulin using the General Practice Research Database. For each year of reporting, the     observed frequencies of prescriptions of retapamulin, with or without same-day     co-prescriptions of topical mupirocin or fusidic acid, will be identified. The five-year     reporting period will include five years of distinct, non-overlapping, non-cumulative     prescription use of first exposure to retapamulin, with or without same-day co-prescription     of topical mupirocin or fusidic acid.   "
251876|NCT01153841|"     The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK     1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix     hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.   "
251877|NCT01153854|"     Rationale: Acute diarrhea (AD) is still a significant morbidity-mortality problem worldwide.     Although oral rehydration therapy is the cornerstone, its anti-diarrheal effect is a     controversial subject. Since ten years ago, Racecadotrilo´s safety and efficacy had been     proved. However, a pharmacoeconomics analysis on this therapeutics has not been published     yet.      Objective: Evaluate the efficacy, safety, tolerability and costs associated with Racecadotril     administration in comparison to a placebo in infants up to 24 months of age with AD in a     hospital (mildly or moderately dehydrated) and ambulatory (no dehydrated) settings at the     National Institute of Pediatrics in Mexico.      Material and Methods: Randomized, double-blind, placebo controlled, clinical trial (RDBCCT)     with pharmacoeconomics analysis (cost minimization) to realize in 454 infants with AD (270     hospitalized and 184 outpatients), 1 to 24 months of age who concomitantly will receive ORT     and Racecadotril (1.5mg./Kg./t.i.d. doe 5 days) (ORT-Rac Group) or placebo (ORT-Placebo     Group). The clinical outcomes in the hospitalized infants to measure will be a) Stool output     rate at 48hs. and at the end of the study; b) duration of diarrhea; c) percentage of     intravenous (IV) needs and d) percentage of adverse events. The outcome variables in     outpatient infants to measure will be a) total liquid and semi-liquid bowel movements during     the study; b) duration of diarrhea and c) percentage of adverse events. The pharmacoeconomics     analysis will involve a cost minimization analysis (CMA). Results will be analyzed through bi     and multivariate analysis using STATA 11.0 for Mac, considering a p value < 0.05 as     significant. The pharmacoeconomics model will made through decisions trees using TreAge Pro     Healthcare v 1.2.0, 2009.   "
251928|NCT01154374|"     The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment     of subjects with diabetic foot ulcers (DFUs).   "
251878|NCT01153867|"     Schema focused therapy (SFT) is an innovative treatment approach to chronic, lifelong     problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and     techniques. This study will determine whether SFT is a suitable and effective treatment for     chronic depression in terms of acute effects and the prevention of relapse/recurrence. The     secondary aim of this study is to identify the underlying mechanisms of change in SFT that     lead to recovery from depression and the prevention of future relapse/recurrence.   "
252002|NCT01155661|"     The primary objective of this study is to evaluate the long-term safety and tolerability of     LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin     reuptake inhibitor (SSRI) for up to approximately 1 year in patients with major depressive     disorder (MDD) who are partial responders to their SSRI treatment.   "
251879|NCT01153880|"     Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical     antibiotics approved for human use. In the United States (US), retapamulin is approved for     the treatment of impetigo in persons nine or more months of age and was launched on 12 April     2007. This five-year study is designed to examine use of retapamulin in the pediatric     population less than nine months of age. We will conduct an annual assessment of prescription     sales claims for retapamulin using the Integrated Health Care Information Services (IHCIS)     National Managed Care Benchmarked Database. For each year of reporting, the observed     frequencies of the exposure, with or without same-day, co-prescribed sales claim of     mupirocin, will be identified. The study objectives are to determine the frequency of     retapamulin sales in a representative US population stratified by the designated age group     and to determine the frequency of same-day sale of the topical agent, mupirocin.   "
251880|NCT01153893|"     The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK     Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster     dose or as a two dose catch-up vaccination in the second year of life to the Nigerian     subjects previously enrolled in the primary vaccination study NCT00678301.      This protocol posting deals with objectives & outcome measures of the booster phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT00678301).   "
251881|NCT01153906|"     The purpose of this post-marketing study is to evaluate the incidence of autoimmune diseases     (AIDs) following females who have received at the least the first dose of Cervarix® as part     of their routine health care.   "
251882|NCT01153919|"     RATIONALE: Romiplostim may cause the body to make platelets.      PURPOSE: This randomized phase II trial is studying how well romiplostim works in treating     hepatitis C-infected patients with thrombocytopenia.   "
251883|NCT01153932|"     The purpose of this study is to determine whether GSK2402968 given as a continuous dose and     as an intermittent dose is effective and safe in the treatment of Duchenne muscular     dystrophy.   "
251884|NCT01153945|"     Much experimental data has suggested that thyroid hormones (T3 and T4) may modulate     neoplastic cells and that T3/T4 deprivation may remove this stimulus. It is now well     established that T3/T4 affects cell division/angiogenesis through binding to integrin avb3,     commonly over-expressed on many cancer cells. In the experimental settings, mimicking     hypothyroidism in the cells is a difficult task. Currently, the use of charcoal stripped     serum is used. Using this method, the serum is stripped not only from T3 and T4, as intended,     but also from central and important cytokines and growth factor. This leads to a reduced rate     of cancer cell proliferation and thus, does not reflect the natural environment in which     cancer cells residue under hypothyroid conditions.      The investigators aim to characterize and establish the effects of serum from hypothyroid     patients on the proliferation/viability of a variety of cancer cell models.   "
251885|NCT01153958|"     This is a prospective, randomized, controlled and multi-center trial to assess the use of     colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were     planned to be enrolled in various centers in China.   "
251886|NCT01153971|"     This study will evaluate the efficacy and safety of MabThera in combination chemotherapy,     followed by maintenance treatment with MabThera. The anticipated time on study treatment is     1-2 years, and the target sample size is <100 individuals.   "
251887|NCT01153984|"     This open-label, single-arm, multi-center study will evaluate the progression-free survival     in participants with histologically documented, advanced and/or metastatic chemotherapy     naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR)     positive mutations and receiving erlotinib treatment. The anticipated time on study treatment     is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.   "
251888|NCT01153997|"     This trial is conducted in Japan. The aim of this trial is to investigate the safety profile     of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy     Japanese subjects. In addition pharmacokinetic parameters will be investigated.   "
251889|NCT01154010|"     The purpose of this study is to determine if a medical device (ActiPatch) that emits a low     frequency pulsed electromagnetic field (PEMF) will benefit patients with anterior uveitis.     Anterior uveitis (aka iritis) is an inflammatory disease involving the front segment of the     eye. This is a common cause of a painful red eye, and ActiPatch has been shown to be     effective in treating tissue inflammation. The conventional treatment of iritis typically     involves frequent administration of topical steroids which have their own inherent risks     (development of cataracts and/or glaucoma). The purpose of this study is to determine if     ActiPatch therapy can be used to shorten the length of time and/or quantity of steroids     administered.   "
251890|NCT01154023|"     The purpose of the study was to evaluate and compare the efficacy of single interventions     (stimulus control instructions, sleep restriction therapy) and multi-component intervention     (stimulus control instructions and sleep restriction therapy) for chronic insomnia in     community dwelling older adults. The subjects were randomly assigned to one of four     conditions: stimulus control instructions, sleep restriction therapy, multi-component     treatment (stimulus control instructions and sleep restriction therapy), or measurement     control.   "
251891|NCT01154036|"     This study will compare the lipid-altering efficacy and safety of switching to     co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or     rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not     achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis     is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to     both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in     low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.   "
252039|NCT01156142|"     RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in     patients undergoing radiation therapy with or without chemotherapy.      PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well it     works compared to placebo in treating oral mucositis pain in patients with head and neck     cancer undergoing radiation therapy with or without chemotherapy.   "
252107|NCT01157026|"     Tocotrienol Rich Fraction (TRF) in combination with Tamoxifen will improve breast cancer     specific survival and recurrence free survival, in women with early breast cancer and     estrogen receptor positive tumors.   "
251892|NCT01154049|"     This is a phase I, open-label, single arm trial, which aims to assess the safety of the     vaccine prepared sm14 in healthy subjects. The product immunogenicity will be evaluated by     conducting serology (anti-sm14 antibodies) and testing of cellular response to the antigen by     the method ELI-SPOT. Each participant will remain in the study for approximately 4 months.     The total study duration is 10 months, considering a period of 6 months for inclusion. Will     be included in the study subjects male and female, between 18 and 49 years, that manifest     their will to participate in the research by signing an Informed Consent Form. Eligible     population for the study are subjects who do not present at screening significant changes in     renal, cardiac and liver functions, complete blood count, clotting, present no acute or     chronic illnesses, are not in the chronic use of any medication, do not have HIV infection or     other immunodeficiency. Pregnant or breastfeeding women will not be included. Volunteers will     receive three doses of vaccine prepared sm14, in doses containing 50 mcg of the antigen,     associated with adjuvant GLA-SE at a dose of 10 mcg, with an interval of 30 days between each     application. Twenty volunteers will be included in the study. This is a convenience sample,     established for the first test of the product in humans, for the initial safety assessment.   "
251893|NCT01154062|"     A study to evaluate pazopanib tablets in male and female adults of non-child bearing     potential with subfoveal CNV due to neovascular AMD. The goal is to assess safety and how     well the subjects tolerate the drug. The study will also look at how the body breaks down and     metabolizes the drug. All subjects will start the study up to 8 days prior to receiving drug.     Once started subjects will take one tablet each day for 28 days. A follow up visit will occur     approximately 2 weeks after drug is stopped.   "
251894|NCT01154075|"     The purpose of this study is to evaluate the use of a novel method to measure adherence to     immunosuppressant medications in predicting rejection episodes in children who had a liver     transplant.   "
251895|NCT01154088|"     The purpose of the observer-blinded study is to determine the immunogenicity and safety of     one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to     one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study     will compare the immunogenicity of two lots of GSK's 134612 vaccine.   "
251896|NCT01146977|"     Evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with     core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1).   "
251897|NCT01146990|"     In the continuing efforts to understand the benefits and risks of in utero exposure to 17P     this study is designed to evaluate differences in developmental outcomes of children, aged 23     to 25 months, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic     (Protocol number 17P-ES-003).   "
251898|NCT01147003|"     This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients     with partial onset seizures.   "
251899|NCT01147016|"     RATIONALE: Neoadjuvant chemotherapy for women with stage II-III Her negative breast cancer     followed by Her2Bi armed activated T cells (ATCs) may significantly improve the pathologic     complete response (pCR) rate at the time of surgery. Arming ex vivo expanded T cells in the     laboratory may help the T cells kill more tumor cells when they are put back in the body.     Giving combination neoadjuvant chemotherapy followed by laboratory-treated T cells before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed.      PURPOSE: This phase II clinical trial is studying how well giving laboratory-treated T cells     after neoadjuvant chemotherapy works in treating women with stage II or stage III breast     cancer undergoing surgery.   "
251900|NCT01147029|"     RATIONALE: GSAO may stop the growth of solid tumors by blocking blood flow to the tumor.      PURPOSE: This phase I trial is studying the side effects and best dose of GSAO in treating     patients with advanced solid tumors that have not responded to therapy.   "
251901|NCT01147042|"     Background:      - Chronic granulomatous disease (CGD) is an immunodeficiency disease in which white blood     cells are unable to kill certain bacteria and fungi. People with CGD are more likely to     develop recurrent life-threatening infections. Certain changes or mutations in genes     contribute to the severity of CGD, and also appear to affect the success of treatment with     interferon-gamma, a substance that is used to improve the immune system s ability to fight     infection. Researchers are interested in studying changes in the immune system caused by     interferon-gamma treatment of CGD in individuals with different mutations that cause CGD.      Objectives:      - To compare changes in the immune system caused by interferon-gamma treatment for CGD in     individuals with different mutations that cause CGD.      Eligibility:      - Individuals of any age who have been diagnosed with CGD and have specific types of     mutations that cause CGD (to be determined after testing).      Design:        -  Participants will be screened with a medical history, physical examination, and blood          and urine tests. Participants must weigh more than 11 kilograms (~24 pounds) to          participate in the study.        -  Participants will receive injections of interferon-gamma once weekly for 4 weeks, twice          weekly for 4 weeks, and then three times weekly for 4 weeks (a total of 24 injections).        -  Blood will be drawn periodically during treatment and for 8 weeks after the treatment,          for a total of 21 weeks on the study. Participants will regularly provide information on          their symptoms and responses to treatment to the study researchers.   "
251902|NCT01147055|"     The purpose of this study is to estimate the effect of multiple doses of Rifampin on the     single dose pharmacokinetics of Crizotinib in healthy volunteers.   "
251903|NCT01147068|"     The purpose of this study is to investigate the safety and immunogenicity of a recombinant     hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at     4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA     formulations.   "
251904|NCT01147081|"     Annual trial for registration influenza vaccine Begrivac with strain composition for season     2010/2011.   "
251905|NCT01147107|"     The main objective is to evaluate the hepatic safety of raltegravir when compared to     efavirenz, both in combination with tenofovir and emtricitabine as first-line HIV treatment     in patients with HIV and hepatitis C coinfection.   "
251942|NCT01154881|"     This trial was conducted in Europe. The aim of this clinical trial was to evaluate the blood     glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2     diabetes.   "
251906|NCT01147120|"     Kentucky ranks 2nd in disability among states, with chronic low back pain (CLBP) as a major     disability, especially in the investigators rural areas. Kentucky and U.S. health care     providers need alternative and effective treatments. Following NCCAM strategic research     recommendations, this study will investigate health services outcomes of complementary and     alternative medicine (CAM) therapies in an existing primary care practice-based research     network (PBRN). The Patients with CLBP are often willing to try therapeutic options outside     the conventional medical spectrum. Massage and relaxation therapies have demonstrated fairly     good efficacy in controlled trials but their effectiveness in the real world of primary     care is only beginning to be evaluated. The long-term goal of the proposed project builds on     the foundation of these two established therapies to improve treatment of chronic low back     pain (CLBP) in primary care practices. Two alternative (CAM) therapies, progressive muscle     relaxation (PMR) and clinical massage therapy (CMT), will be studied. The short-term     objectives of the proposed project are to: (1) examine outcomes of CAM for patients with CLBP     referred from primary care practices, and (2) better understand physician decision-making to     recommend CAM therapy for CLBP. Specific Aim 1 will evaluate improvement in health-related     outcomes for patients with CLBP when referred to PMR or CMT from primary care. Specific Aim 2     will explore selected factors in primary care physicians' decisions to recommend CAM therapy     to these patients. The proposed study is unique in that it addresses real life clinical     situations and decision-making in both urban and rural clinical practices within an existing     PBRN. Should such CAM referral prove successful for ameliorating CLBP, it would provide     relatively low cost, non-addictive treatment options for inclusion in the repertoire of     primary care physicians.   "
251907|NCT01154101|"     This double-blind, placebo-controlled study will be conducted at 5 study centers in the     United States. Approximately 30 subjects with moderate to severe plaque-type psoriasis will     take part. The study will consist of a screening period of up to 21 days, a 12-week treatment     period with 7 on-treatment clinic visits (approximately one every 2 weeks) and a post-dosing     follow-up clinic visit approximately 30 days after the last dose of study drug is taken.      Subjects will be randomized to receive either 250mg, 500mg or 1000mg of study drug or     placebo. Study drug will be taken by mouth on a full stomach, every day for 84 days.      Vital signs, clinical laboratory results (hematology, chemistry, and urinalysis), ECGs and     physical examinations will be assessed at periodic intervals from Day 1 through Day 84.      A skin biopsy will be taken at the beginning and the end of the dosing period to evaluate any     effects of the study drug on psoriasis. Investigators will perform other psoriasis     evaluations (including the Psoriasis Area and Severity Index [PASI] and the Physician's     Global Assessment [PGA] at 5 different times throughout the study to quantify the effects of     SRT2104 on psoriasis activity.      Subjects will complete questionnaires throughout the study, to document their sense of     well-being and mood at 4 different times during the study.      Five blood samples will be obtained at different timepoints during the study, to measure the     amount of SRT2104 in the body.   "
251908|NCT01154114|"     The purpose of this study is to determine any differences in pharmacokinetic parameters of     darapladib when dosed to people with moderate liver disease as compared to when dosed in     normal healthy volunteers.   "
251909|NCT01154127|"     The ability for patients with COPD to exercise is limited due to the deterioration of their     lung function. NVA237 is being developed to treat COPD. This study is designed to look at how     well NVA237 improves the ability to exercise in patients with moderate to severe COPD.   "
251910|NCT01154140|"     This study will evaluate the anti-cancer effects of crizotinib when compared with standard     chemotherapy in patients with ALK positive lung cancer.   "
251911|NCT01154153|"     The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg)     and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA)     axis function as measured by serum cortisol AUC(0-24 hr) in children (>=2 to <12 years old)     with allergic rhinitis (AR).   "
251912|NCT01154166|"     This is a phase III, multicenter, randomized, double-blind, parallel group,     placebo-controlled study to compare the efficacy of 6-months therapy of ropinirole Prolonged     Release (PR) with that of placebo as adjunctive therapy to L-dopa in Parkinson's disease     patients not optimally controlled on L-dopa. This study will be conducted in China. Subjects     will have total 14 visits over the 26 week duration of the study.      Following screening, eligible subjects will receive study medication during the fourteen day     placebo run-in period which they will be instructed to take in addition to their background     L-dopa. If subjects are still eligible at the end of the placebo run-in period they will be     randomized (1:1) to receive once daily doses of ropinirole PR or identical appearing placebo     tablets. Dosing will start at 2 mg ropinirole PR, or placebo equivalent. During the 24 week     treatment phase, the subjects dose will be adjusted according to the recommended schedule to     achieve symptomatic control. All subjects must be titrated to a minimum dose of 6 mg/day. If     sufficient symptomatic control is not achieved or maintained at a dose of 6mg/day of     ropinirole PR, the daily dose should be increased by 2mg at weekly or longer intervals up to     a dose of 8mg/day.If sufficient symptomatic control is still not achieved or maintained at a     dose of 8mg/day of ropinirole PR, the daily dose should be increased by 4mg at two weekly or     longer intervals. Further dose titration should not be conducted within the final 8 weeks of     the treatment phase. The maximum recommended daily dose is 24mg.      The planned reduction in L-dopa dose will begin once subjects are titrated to Dose Level 4 or     Dose Level 5 of study medication. For each increase in study medication, there will be a     corresponding decrease in L-dopa. If loss of symptom control occurs with the reduction in the     background L-dopa dose, the dose of study medication should be increased to the next higher     dose level with no adjustment in the dose of L-dopa. If loss of symptom control persists,     subjects should be titrated up an additional dose level. Subjects who do not experience an     improvement in symptoms following upward titration by 2 dose levels of study medication,     should be rescued with L-dopa.      Subjects will be dispensed down-titration medication at the study completion/early withdrawal     visit if the patient did not enter extension study and should be scheduled to return for a     follow up visit 4 to 14 days after the last dose of study medication. The extension study aim     to evaluate the safety profile of ReQuip PR during long-term treatment in subjects with     advanced parkinson's disease.   "
251913|NCT01154179|"     During patients' stay in the hospital, some of the patients may require artificial feeding     for various reasons either through a vein or through a tube going directly to the gut.     However, the amount of feeding that can be considered 'adequate' is unclear due to lack of     research data. The current evidence the investigators have suggests that doctors might be     giving patients more than they require, which might carry some risks. This hasn't been proven     until now and there is no evidence as yet to show investigators exactly how much the doctors     should feed patients.      The aim of the study is to see whether feeding patients less than what they are currently     been feed is associated with better outcome.      The patients will be randomly (like tossing a coin) allocated into 2 groups. One group will     get 100% of the current amount; the second group will get 60%. The investigators will then     compare the groups to decide if feeding patients less than the current practice is associated     with better outcomes.   "
251943|NCT01154894|"     In a double-blind, placebo-controlled 16-week trial investigators administered daily doses of     either youths with autism spectrum disorders.ARA and DHA supplementation significantly     improved communication as well as social withdrawal symptoms. This pilot study provides the     first evidence that supplementation with larger ARA doses added to DHA improve impaired     social interaction in youths with Autism Spectrum Disorders (ASD).   "
251999|NCT01155622|"     Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in     patients recovered from a ventricular fibrillation cardiac arrest. The same therapy is     suggested with less evidence for asystole as first rhythm after cardiac arrest. The purpose     of this study is to determine whether different temperature targets (32º vs 34º) may have     different efficacy in the treatment of post-cardiac arrest patients. If successful, this     pilot study will eventually form the basis for a larger, multicentric randomized clinical     trial.   "
251914|NCT01154192|"     In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is     excessive ovarian androgen production marked by increased serum testosterone (T) and     androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis     that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene     expression with accentuated 17-hydroxylase activity leading to exaggerated     17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast,     T and A responses did not distinguish between PCOS and normal women, although these androgens     were clearly greater in the former compared to the latter group. As a result, 17P     responsiveness has been employed to determine the functional capacity of the ovary to produce     androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a     dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU. The investigators propose     to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG     after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls.     This will allow for a comparison of these adolescents' ovarian functional capacity to produce     androgens.   "
251915|NCT01154205|"     The purpose of the registry is to assess workload of a Home Monitoring based follow up for     Biotronik ICD and CRTD patients.   "
251916|NCT01154218|"     The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule     (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC     relative to Powder in Capsule (PIC) of crizotinib, and lack of an effect of high fat meal on     the pharmacokinetics (PK) of crizotinib when administered as CIC Formulation in healthy     volunteers.   "
251917|NCT01154231|"     The survey is intended to investigate the following matters, etc. under the actual use status     after marketing in all patients who are administered this drug for a certain period of time     after the launch.        1. Occurrence status of adverse events        2. Factors that may influence the safety        3. Efficacy In addition, the following occurrence statuses will be investigated as priority          items of the survey: Incidence rate of inhibitor, reduction in drug, efficacy, Allergic          reaction, and Thrombosis.   "
251918|NCT01154244|"     The purpose of this study is investigating the clinical characteristics of newly diagnosed,     drug naïve type 2 diabetic patients according to insulin secretion and insulin resistance.   "
251919|NCT01154257|"     Cleaning the mouth is difficult in critically ill patients who require support from a     breathing machine (ventilator). This is because the plastic (endotracheal) tube which is a     necessary interface between patient and ventilator impedes cleaning. New evidence suggests     that poor oral health may be linked to ventilator associated pneumonia. Throughout the world     both toothbrushes and foam swabs are used to clean the teeth and remove dental plaque,     however it is unknown if one method is more effective than the other. The purpose of this     study is to establish which (if any) method is most effective at removing plaque in this     population of patients.   "
251920|NCT01154270|"     The COSMIC trial is a prospective, mono-centric, phase II trial evaluating toxicity and     efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and     carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local     control, disease-free survival, and toxicity. Planned accrual of the trial includes 54     patients with histologically proved (≥R1-resected, inoperable or Pn+) salivary gland     malignancies. Treatment consists of 24 GyE carbon ions (8 fractions) and 50 Gy IMRT (2.0 Gy/     fraction).   "
251921|NCT01154283|"     The purpose of the study is to test whether noninvasive positive pressure ventilation (NIPPV)     without expiratory positive airway pressure (EPAP) (inspiratory positive airway pressure     (IPAP)-only) will result in an increase in patient usage of NIPPV compared with standard,     Bi-level NIPPV. Secondarily, the investigators will assess measures of dyspnea, quality of     life, patient satisfaction, and side effects.   "
251922|NCT01154296|"     Project Aware is a randomized controlled clinical trial in which individuals seeking medical     or health services at sexually transmitted disease (STD) clinics are recruited to participate     in a multi-center HIV testing and counseling study. The investigators will assess the     relative effectiveness and cost-effectiveness of (1) on-site HIV rapid testing with brief,     participant-tailored prevention counseling vs. (2) on-site HIV rapid testing with information     only. The investigators will evaluate the effect of counseling on one primary outcome: STI     incidence. Secondary outcomes will be reduction of sexual risk behaviors, substance use     during sex (i.e., being under the influence during sex) and cost and cost effectiveness of     counseling and testing. Participants will be assessed for sexually transmitted infections,     HIV testing history and sexual and drug use risk behaviors at baseline and at 6-months     follow-up. Approximately 5,000 individuals seeking medical or health services from     approximately 9 STD clinics throughout the United States will be randomized. These     individuals will be 18 years of age or older and efforts will be made to recruit a sample of     study participants that reflects the proportion of minorities and gender in the STD clinic     performance sites from which the investigators are recruiting.   "
251923|NCT01154309|"     The investigators will adapt and test an existing treatment (group CBT for depression) for     use in outpatient substance use treatment settings as delivered by trained substance use     counselors. The investigators expect that treatment will lead to improved depression and     substance use outcomes.   "
251924|NCT01154322|"     The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating     obstructive sleep apnea (OSA) in a pediatric population.   "
251925|NCT01154335|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of the combination     of OSI-906 and everolimus for the treatment of patients with refractory metastatic colorectal     cancer.   "
251926|NCT01154348|"     The purpose of this study is to determine the safety and pharmacokinetics of double-blind     S-707106 alone and in combination with open-label metformin in patients with type 2 diabetes     mellitus   "
251927|NCT01154361|"     This is a multicenter study recruiting patients with angioedema induced by ACEI.      Open-label treatment with subcutaneous Icatibant compared to a historic group of 47 patients     with ACE inhibitor induced angioedema which the investigators have been previously treated in     the investigators centers with current standard therapy (250 mg methylprednisolon and 2 mg     clemastine).      In cases with fast progression of edema after application the study-drug, a second     application with icatibant could be necessary. Rescue medication and intervention.   "
251929|NCT01154387|"     Induction therapy with antibodies is administered during transplant surgery and for a short     period of time following transplant surgery in an effort to render the immune system less     able to mount an initial rejection response. In general, induction therapy is associated with     better outcomes compared to the absence of induction therapy. However, currently used     induction agents, some of which are not labeled or indicated for induction therapy in     transplantation, have drawbacks related to long-term immune system suppression increasing     susceptibility to opportunistic infections or malignancies, and other immune-mediated side     effects.      An unmet medical need exists for a more specific approach to prevent acute organ rejection,     without unnecessarily exposing the patient to non-specific or open-ended immune suppression,     which may exacerbate the risks of infections and malignancies. TOL101 is a novel antibody     that targets a very specific immune cell type that is critical in the acute organ rejection     response. In this two-part study, TOL101 will be evaluated for the prophylaxis of acute organ     rejection when used as part of an immunosuppressive regimen that includes steroids, MMF, and     tacrolimus in first time kidney transplant recipients.      This study will test the hypothesis that a more specific approach (with TOL101) to prevention     of acute organ rejection may provide similar or better efficacy than the currently used     induction antibodies (such as Anti-Thymocyte Globulin or Thymoglobulin) while carrying fewer     risks in terms of opportunistic infections, malignancies and adverse effects.   "
251930|NCT01154400|"     The aim of this study is the first aim of a NIH project that consists of 3 aims. The first     aim examines the acute effects of two high-quality milk proteins (casein vs. whey) on     whole-body and muscle protein metabolism in COPD patients with severe loss of muscle mass and     the effects of adding leucine. The principal endpoints will be the extent of stimulation of     net whole body protein synthesis as this is the principal mechanism by which either amino     acid or protein intake causes muscle anabolism. After determining the optimal nutritional     formulation based on the first aim we will continue to work on the second and third aim where     fish oil supplementation will be part of the nutritional intervention as well.   "
251931|NCT01154413|"     To asses the effectiveness of implementing a diabetes management protocol (early     insulinization, avoiding use of SSI) in a hearth hospital's non-intensive care unit.   "
251932|NCT01154426|"     This phase I trial is studying the side effects and best dose of giving ABT-888 together with     gemcitabine hydrochloride in treating patients with advanced solid tumors. ABT-888 may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used     in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888     together with gemcitabine hydrochloride may kill more tumor cells.   "
251933|NCT01154764|"     This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the     pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers.   "
251934|NCT01154777|"     Neurofeedback, a neuro-cognitive training method based on operant conditioning, will be     employed with 90 children with the Autistic Spectrum Disorders (ASD) over a 60 session     training period to improve the limiting behavioral and sensory symptoms Autism presents (with     each collaborative site working with 45 of the 90 participants). This study seeks to     demonstrate that Neurofeedback training, a non-invasive approach based on Learning Theory,     will mitigate presenting symptoms of Autism, and ultimately render the person with Autism     significantly more able to interact with his/her environment successfully, independently     function on a day-to-day basis, and improve overall mental health.   "
251935|NCT01154790|"     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of     3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7     total days in healthy volunteers.   "
251936|NCT01154803|"     The purpose of this study is to determine whether 14 days nutritional supplementation with     Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection     will prevent malnutrition and reduce the frequency of morbidity.   "
251937|NCT01154816|"     This phase II trial is studying the side effects of and how well alisertib works in treating     young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
251938|NCT01154829|"     The investigators want to relate disturbances in first-episode schizophrenic patients in     (dopaminergic) D2 receptors, brain structure, brain function, and information processing to     each other and to psychopathology. Additionally, the investigators want to examine the     influence of D2 receptor blockade on these disturbances. The investigators expect     disturbances in the dopaminergic system at baseline to correlate with specific structural and     functional changes and with disruption in information processing as measured with     psychophysiological and neurocognitive methods - and investigators expect D2 receptor     blockade to reverse some of the functional and cognitive impairments.   "
251939|NCT01154842|"     Serum FGF-23 levels will be measured in patients with a history of coronary artery disease     and aortic valve calcifications.It will be searched whether patients with MPI>0.47 had higher     or lower serum FGF-23 levels than those with MPI<0.47. Correlations will be examined between     log FGF-23 levels and LVMI and MPI. Uni and Multivariable-adjusted regression analyses     regarding whether increased log FGF-23 concentrations are independently associated with     increased left ventricular mass index and increased MPI, will be performed.   "
251940|NCT01154855|"     The goal of this project is to study the immune activity of certain proteins present in the     blood of patients with severe periodontal disease. Periodontal disease (gum disease) is the     major cause of tooth loss among adults. Moderate to severe periodontal disease is reported to     affect 5-15% of American adults. It begins with an infection of the tissues surrounding the     teeth, and leads to a worsening inflammatory response. This study will aid in clarifying the     way in which gum disease might affect certain systemic diseases.   "
251941|NCT01154868|"     The purpose of this study is to document and evaluate how a bone graft material (Healos®) can     help rebuild bone width. Dental implants can only be placed when enough bone is found and     this bone graft may help to rebuild bone width for dental implant placement. The ultimate     goal of this study is to evaluate how this graft material can help bone healing.   "
251944|NCT01154907|"     Schistosomiasis is a poverty-related water-transmitted parasitic disease affecting more that     200 million people world wide. Infection with Schistosoma haematobium may cause Female     Genital Schistosomiasis (FGS) with pathological lesions in the female genital tract,     especially the cervix. Findings indicate that FGS is a hitherto under-diagnosed illness of     young women in endemic poor tropical countries, deserving further attention. A     cross-sectional study from Zimbabwe indicated that the pathologic genital lesions were     unchanged two years after praziquantel treatment in adult women whereas in those who had been     treated with praziquantel in childhood the prevalence of genital lesions was significantly     lower. Furthermore, a higher prevalence of HIV was detected in women with FGS compared to     those without. The proposed project aims at achieving a better understanding of how annual     distribution of praziquantel to pre- and post-pubertal schoolgirls may prevent FGS. This     information can be of use in current schistosomiasis control programs in the near term     resulting in improved strategies for treatment. Preventing or reducing the risk of FGS and     genital lesions will lead to improved reproductive health among in women living in     schistosomiasis endemic areas.      Project Goal: Contribute to a reduction of the global burden of female genital     schistosomiasis (FGS) through improved knowledge about the prevention of gynecological     lesions and through improved diagnosis of FGS.   "
251945|NCT01154920|"     The goal of this clinical research study is to learn which chemotherapy combination is more     effective in treating locally advanced head and neck squamous cell carcinoma. The side     effects of these combinations will also be studied.   "
251946|NCT01154933|"     Exenatide has been shown to result in better glycemic control in type II diabetes patients.     Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to     decreased inflammation by virtue of better glycemic control and weight loss.      The purpose of this study is to determine if the addition of Exenatide to diabetic patients     will reduce the requirements of insulin particularly the short acting insulin. Exenatide may     also lead to decreased inflammation by virtue of better glycemic control and weight loss, or     an independent effect.   "
251947|NCT01154946|"     The aims of this study are        -  to confirm whether detrusor after-contraction (DAC) is a true contraction or not with a          new approach        -  and to understand clinical implication of DAC   "
251948|NCT01154959|"     The immune responses in latent tuberculosis are poorly understood. While it is difficult to     define the onset of latency during natural infection, patients undergoing treatment for     tuberculosis are driven into a state of latency or cure. The present study on the effect of 3     and 4 month regimens containing moxifloxacin in sputum smear and culture positive pulmonary     tuberculosis (TRC Study number 24) offers us the opportunity to study definitive immune     responses pre and post treatment. We will evaluate a variety of innate and adaptive immune     responses in patients before and after treatment and our study will compare the differences     in immuno-phenotype (eg. Markers of T, B and NK cell activation, proliferation and regulatory     phenotype) and function (eg. Production of cytokines, proliferative responses to TB antigens)     at different time points following treatment. In addition, since a small percentage of     patients will undergo relapse following treatment, the kinetics of immune responses in these     patients will used to assess immunological predictors of relapse in tuberculosis.   "
251949|NCT01154972|"     When a person has breast cancer it is necessary to find out whether the cancer has spread to     the lymph nodes in the armpit because if it has, further treatment is likely to be needed.     There are many of these nodes but when the breast cancer spreads, it does so in a     step-by-step fashion, starting with the so-called Sentinel Lymph Node (SLN). At present, the     only way to be sure whether there is cancer in the lymph nodes or not is to perform an     operation to remove at least the SLN. If the pathologist finds cancer in the SLN, a second     operation is usually required to remove further nodes in case they contain cancer too.     Surgical removal of the lymph nodes in the armpit can cause difficulties for the patient     afterwards, such as pain and swelling in the arm. If there is no cancer in the SLN, no     further operations on the armpit are needed. The investigators wish to find out whether in     some patients, operations on the armpit can be avoided completely. The first step in doing     this is to test whether the investigators can find out which is the SLN before the operation,     using a combination of an injection and ultrasound scanning. The injection - into the skin of     the breast - would be a radioactive substance, which is the usual way the surgeon finds the     SLN. The radioactive substance collects in the SLN and the investigators would use a gamma     probe over the surface of the armpit to detect the radiation. In this initial study, the     investigators would aim to find the SLN before the operation and place a marker wire in it so     that the surgeon could check whether the investigators had found the correct node.   "
251950|NCT01154985|"     This is a controlled study to determine the effectiveness and safety of ethyl icosapentate     (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).   "
251951|NCT01154998|"     There is a rare condition causing scarring of the lungs termed interstitial lung disease.     This comprises a group of conditions which can be divided into separate diseases. The aim of     this study is compare a group of patients (the cases) with 2 types of this disease (fibrotic     non-specific interstitial pneumonia (NSIP) and idiopathic pulmonary fibrosis (IPF)) with     patients without the disease. The study will look at the 2 groups and their exposures to     factors such as medications, smoking, previous jobs, previous medical problems and     specifically heart disease and any operations or procedures involving the heart. There have     been previous studies showing a link between heart disease and scarring of the lungs. This     study will look at whether this association is stronger in one or the other type of lung     scarring diseases.   "
251952|NCT01155011|"     The purpose of this study was to assess whether a 6-month multilevel physical activity     intervention can significantly increase physical activity levels in sedentary adults, 65 and     older, living in Continuing Care Retirement Communities (CCRCs).      Sedentary residents (N=307) in 11 CCRCs received the multilevel MIPARC intervention or a     control health education program for 6 months. A group randomized control design was employed     with site as the unit of randomization. The intervention was delivered through group     sessions, phone calls, printed materials, tailored signage and mapping and targeted peer led     advocacy efforts.   "
251953|NCT01155024|"     The purpose of this study is to evaluate a new prosthetic socket construction technique in     order to improve the quality of care to lower extremity amputees.   "
251954|NCT01155037|"     This is a randomized, open label, phase II trial to evaluate the safety and immunogenicity of     two different schedules of vaccination against influenza A H1N1 in HIV-infected individuals,     in which each of the randomized groups will be compared with HIV-negative volunteers     vaccinated with the regimen indicated by the Brazilian National Immunization Program. Will be     included in the study HIV-infected patients, stratified by CD4 count (< 200 cells/mm3 or >     200 cells/mm3) at the time of screening for the study, not receiving antiretroviral therapy     treatment or receiving stable treatment for at least 8 weeks, with no plans to change over     the next 6 months, eligible to receive vaccine against influenza A H1N1. The control group     will be formed by HIV-negative individuals, confirmed by serology performed at screening,     eligible to receive vaccine against influenza A H1N1. Patients infected with HIV will receive     one of two possible vaccination regimens: 1) 3.75 µg in two applications 21 days apart, 2)     7.5 µg in two applications 21 days apart. The volunteers in the control group will receive a     single application of 3.75 µg dose of the vaccine. The study's hypotheses are: 1) The vaccine     against the H1N1 virus promotes antibody titers above the level specified for protection     (seroconversion), being as safe and well tolerated in patients HIV-1 infected as in non     HIV-infected volunteers; 2) The proportion of seroconversion for H1N1 virus vaccine at a dose     of 3.75 µg in HIV-1-infected patients is similar to the proportion of seroconversion induced     by the same vaccine at a dose of 7.5 µg; 3)The proportion of seroconversion with one dose of     the vaccine against H1N1 virus is similar to the proportion after the second dose.   "
251955|NCT01155050|"     This study will assess the effect of in-home tele-health monitoring on health outcomes for     LSUHCSD chronic disease, overweight or obese patients diagnosed with type II diabetes or     hypertension.   "
251956|NCT01155063|"     Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical     practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons     for early discontinuation.   "
251957|NCT01155076|"     The purpose of the study is to determine the effects of 8 weeks Vitality Product     supplementation on physical and mental function in middle-aged adults   "
251958|NCT01155089|"     The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fed     conditions   "
251959|NCT01155102|"     The objective of this study was to prove the bioequivalence of Anastrozole Tablet under     fasted conditions.   "
251960|NCT01155115|"     The objective of this study is to compare the lower airways inflammatory response to     infection/pulmonary exacerbation among children known to have Primary Ciliary Dyskinesia     (PCD) with children known to have Cystic Fibrosis (CF) as measured by the presence of     inflammatory mediators in expectorated/induced sputum.   "
251961|NCT01155128|"     Introduction: Chronic kidney disease (CKD) is now an important public health issue. While     0.1% of the population is on dialysis, approximately 4.5% of subjects have renal dysfunction     (glomerular filtration rate <60 ml/min/1.73 m2). These patients have a high mortality of     cardiovascular disease (CVD) with low quality of life and survival, despite high expenditure     on their treatment. Hypertension (SAH) is both a cause and a complication of CKD. In     addition, CKD and hypertension are risk factors for CVD. The nephropathy that are not on     dialysis are less studied than those on dialysis. Strategies are needed to maintain renal     function in these patients and mitigate the risk factors for CVD. A sedentary lifestyle can     be an important determinant of morbidity of mortality. This study aims to determine the     effect of exercise in patients with CKD not yet on dialysis.      Methodology: A randomized clinical trial in hypertensive patients with CRF. After recruitment     of participants and completed baseline surveys, those eligible for inclusion and consented to     participate in the study will be randomly assigned. We use the technique of randomization in     blocks of fixed size of six persons.      Variables to be collected: demographic, socioeconomic, behavioral, anthropometric, blood     pressure, laboratory tests (anemia, the lipid profile, blood glucose, inflammatory markers     and number of peripheral endothelial progenitor cells) and quality of life. These patients     will be re-interviewed in the middle period of the study (10 weeks) at the end of the     intervention (20 weeks) and 10 weeks after the end of the intervention. The intervention     group will participate in two weekly sessions of exercise.      Therefore, facing the epidemic of CKD, this study intends to fill the data gaps about the     impact of physical activity in patients with CKD on dialysis.   "
251962|NCT01155141|"     FSGS is an immunologic disorder wherein circulating immune proteins cause damage to the     kidneys and progressive injury and scarring. Corticosteroid therapy is occasionally, but not     nearly universally, successful in reducing proteinuria, and when patients respond, they have     a favorable prognosis. The investigators believe that ACTH therapy (H.P. Acthar Gel) can     provide a more rapid, well tolerated reduction in glomerular injury.   "
251963|NCT01155154|"     Research Question: In emergency department patients with simple hand cuts, do prophylactic     antibiotics reduce the risk of wound infections?   "
251964|NCT01155167|"     The aim of the study is to facilitate radial artery access for cardiac catheterization. The     investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery     spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized     to topical nitroglycerin + lidocaine versus placebo.   "
251965|NCT01155180|"     You are invited to take part in a research study about the role of leptin (a fat cell hormone     that normally circulates in the blood) on maintaining a reduced body weight. This study will     also evaluate how leptin impacts hormone levels, metabolic rate (how many calories are used     at rest), autonomic nervous function (the part of your brain that controls your heart rate     and breathing), changes in body composition and your sense of appetite. Under normal     conditions, leptin is secreted by fat cells and signals to the brain to decrease appetite and     regulate energy usage and hormone levels. When obese individuals lose weight, their leptin     levels go down, which may cause them to later regain the weight. This study will provide     leptin as an investigational medication (not yet approved by the Food and Drug     Administration) to increase the levels of the leptin hormone that normally circulates in your     blood back to a normal range. We will see if this can help you to maintain your reduced body     weight and improve your hormonal and metabolic function.   "
251966|NCT01155193|"     Evaluation of Respiratory Syncytial Virus (RSV) Hospitalization and the impact of risk     factors on preterm infants, infants with congenital heart disease and infants with     bronchopulmonary abnormality of development immunized with Synagis.   "
251967|NCT01155206|"     Insulin resistant states are characterized by hepatic lipoprotein (VLDL) particle     overproduction. Numerous hormonal and nutritional factors are known to influence hepatic     lipoprotein particle production, including insulin and free fatty acids (FFA). In contrast to     the liver, the intestine has traditionally been viewed as a 'passive' organ with respect to     lipoprotein production, with intestinal lipoprotein particle production determined mainly by     the amount of fat ingested and absorbed. Glucagon plays a key role in the regulation of     carbohydrate and fatty acid metabolism and has recently been shown for the first time to     regulate hepatic lipoprotein production in mice. Ours will be the first study to investigate     the effect of glucagon on hepatic and intestinal lipoprotein production in humans.   "
251968|NCT01155219|"     This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of     Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially     treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance     to prostaglandin eye drops.   "
251969|NCT01155232|"     Teriparatide (PTH) is the only bone formation therapy that has been approved for the     treatment of postmenopausal osteoporosis in Canada. Osteoporosis is currently diagnosed using     a bone mineral density (BMD) scan, which measures the amount of mineral (calcium etc) in     bones (the higher the amount of mineral, the lower the fracture risk). Although BMD is linked     to bone strength and is used to measure fracture risk, it does not give information on bone     structure (called bone geometry) which can also tell us a great deal about fracture risks.     Clinical trials have shown that teriparatide increases BMD at the lumbar spine and total hip,     while BMD at the forearm may decrease after 20 months of therapy. However, bone biopsies of     the pelvis done on people taking teriparatide show improvement of bone geometry (ie bone     thickness and increased trabeculae (small interconnecting rods of bone), suggesting that a     change in bone geometry at the wrist may be occurring as well. Currently, there is a new     technology, high resolution pQCT (HR-pQCT) that can assess bone geometry without a biopsy.     Since bone strength is affected both by BMD and bone structure (as well as other material     properties), our group is interested in examining changes in bone geometry at the radius and     tibia in men and women with osteoporosis who receives 24 months of teriparatide therapy.      The investigators believe that this new approach of measuring bone strength will help us     better understand the mechanisms of therapeutic efficacy of teriparatide. In addition,     measuring indices of bone strength such as the material composition (bone mineral content or     BMD) and structural properties of bone (size and shape, and microarchitecture) may provide     more data about the mechanisms of how teriparatide treatment can decrease fracture risk. In     the end, this data will benefit and improve patient care by allowing us to show patients and     their providers that whether BMD increases, decreases or stay the same, there are changes in     their bone geometric structure with teriparatide therapy that increases bone strength.   "
251970|NCT01155245|"     This study will investigate the effects on bone quality of a medication (Teriparatide) used     to treat people with severe osteoporosis. Teriparatide is the only bone formation therapy     that has been approved for the treatment of postmenopausal osteoporosis in Canada.     Osteoporosis is currently diagnosed using a bone mineral density (BMD) scan, which measures     the amount of mineral (calcium etc) in bones (the higher the amount of mineral, the lower the     fracture risk). Although BMD is linked to bone strength and is used to measure fracture risk,     it does not give information on bone structure (called bone geometry) which can also tell us     a great deal about fracture risks. Clinical trials have shown that teriparatide increases BMD     at the lumbar spine and total hip, while BMD at the forearm decreases after 20 months of     therapy. Whether this decrease of BMD at the forearm suggests a higher risk of wrist fracture     or a change in bone structure is unclear. Bone biopsies of the pelvis done on people taking     teriparatide shows improvement of bone geometry (ie bone thickness and increased trabeculae     (small interconnecting rods of bone), suggesting that a change in bone geometry at the wrist     may be occurring as well. Currently, there is a new technology, high resolution pQCT     (HR-pQCT) that can assess bone geometry without a biopsy. Since bone strength is affected     both by BMD and bone structure (as well as other material properties), our group is     interested in examining changes in bone geometry at the forearm (a non-weight bearing site)     and ankle (a weight bearing site) in postmenopausal women with osteoporosis who receive 24     months of teriparatide therapy. The investigators believe that this new approach of measuring     bone strength will help us better understand whether teriparatide has different effects at     different bone sites.   "
251971|NCT01155258|"     RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as vinorelbine ditartrate, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving temsirolimus together with vinorelbine ditartrate may kill more     tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of giving temsirolimus     and vinorelbine ditartrate together in treating patients with unresectable or metastatic     solid tumors.   "
251972|NCT01155271|"     The study was designed to test the following hypotheses:      In obese patients with OSAS, the benefit of the combination of exercise training + continuous     positive airway pressure (CPAP) will be higher than CPAP alone in term of functional     capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life.      In obese patients with OSAS, the benefit of training using ventilatory assistance (NIV)     during cycloergometer [cycloergometer with NIV] or respiratory muscles training (spirotiger)     in addition to cycloergometer [cycloergometer + spirotiger] will be higher than     cycloergometer training alone [cycloergometer] in term of functional and exercise capacities.      Dyspnea during walking test and respiratory muscle strength at baseline could influence the     response to combined exercise training such as [cycloergometer + NIV] or [cycloergometer +     spirotiger]   "
251973|NCT01155284|"     Sanford Research/USD proposes to study the combination therapy of oral administration of     sitagliptin and lansoprazole versus placebo for the preservation of pancreatic beta cells     still present in patients with recent-onset diabetes and possibly regenerating their beta     cells, while safely down-regulating the autoimmune response directed against the beta cells.   "
251988|NCT01155479|"     This is a one year, 2-part study to determine the efficacy and safety of preladenant, an     adenosine type 2a (A2a) receptor antagonist. The purpose of Part 1 (first 26 weeks) is to     determine if preladenant is effective in the treatment of early Parkinson's Disease. The     purpose of Part 2 (second 26 weeks) is to determine if preladenant is safe and well     tolerated. The primary efficacy hypothesis is that at least the 10 mg twice daily dose of     preladenant is superior to placebo as measured by the change from Baseline to Week 26 in the     sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts 2 and 3 scores (UPDRS2+3).   "
251989|NCT01155492|"     The gut may be a portal of entry for agents that cause or contribute to the causes of     Parkinson's disease (PD). The investigators are studying changes in the normal population of     gut flora and in intestinal permeability and their associations with early PD.   "
251974|NCT01155297|"     Introduction: Chronic Kidney Disease (CKD) is considered an important public health problem,     with prevalence of 9.6% in our population. The CKD has as main symptoms fatigue, muscle     weakness and poor exercise tolerance, which directly contribute to physical inactivity and     low mobility, increasing the risk of morbidity and mortality in CKD patients with significant     impact on quality of life of these patients. Thus, patients with CKD have poor quality of     life, high incidence of cardiovascular diseases, high prevalence of endothelial dysfunction,     the consequent increase in arterial stiffness and serum concentration of asymmetric     dimethylarginine (ADMA). It is believed that the conditioning of these patients may reduce     cardiovascular risks and improve the quality of life. Aim of the study: Evaluate the impact     of exercise training in relation to functional capacity, quality of life, pulse wave velocity     and ADMA in patients with CKD on dialysis. Materials and methods: Is a randomized controlled     study, with 34 CKD patients on conservative treatment, divided into control group (with     stretching exercises and metabolic exercises) and training group, those undergoing physical     training, aerobic and resistance during six months. Before and after exercise training,     patients will be assessed using the SF-36 and IPAQ. Also be held assessment of pulse wave     velocity, measurement of serum ADMA and spirometry testing. Statistical analysis consisted of     t test for independent data or chi-square when appropriate.   "
251975|NCT01155310|"     The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2)     78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate     and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive     Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.   "
251976|NCT01155323|"     This study seeks to evaluate and compare the clinical performance of two daily disposable     soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.   "
251977|NCT01155336|"     This study will explore the safety and effectiveness of adding Lovaza® to the therapeutic     program utilized internationally for the treatment of individuals with acute coronary     syndromes.   "
251978|NCT01155349|"     The purpose of this study is to examine the feasibility and potential effectiveness of a     cognitive training program among persons with Parkinson's disease. It is hypothesized that     individuals with PD will be able to complete and benefit from the intervention.   "
251979|NCT01155362|"     The primary objective of the study is to estimate the treatment effect of 3 different doses     of PDA001 versus placebo in subjects with moderate-to-severe Crohn's Disease. The secondary     objective of the study is to assess the safety and tolerability of PDA001 versus placebo in     the above-mentioned patient population.   "
251980|NCT01155375|"     To evaluate the efficacy and safety of IV ferumoxytol compared with oral iron for the     treatment of pediatric subjects with chronic kidney disease.   "
251981|NCT01155388|"     To evaluate the efficacy and safety of IV ferumoxytol compared with oral iron for the     treatment of pediatric subjects with nondialysis-dependent chronic kidney disease.   "
251982|NCT01155401|"     The purpose of this study is to determine and analyse the incidence, severity, risk factors     and routine management of acute drug-induced upper gastrointestinal bleeding (UGIB) in the     population of Russian patients   "
251983|NCT01155414|"     The primary objective of this study is to assess the comparative gastrointestinal (GI)     tolerance of normal term infants to two experimental powdered formulas compared with a     commercially available powdered formula.   "
251984|NCT01155427|"     The purpose of this study is to support the clinical value of entecavir by assessing the     relationship between viral load and histological improvement.   "
251985|NCT01155440|"     Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel     movement will be faster and decrease pain intensity, opioid consumption and side effects,     length of hospital stay; probably as a result of a significant opioid sparing and attenuated     inflammatory response.   "
251986|NCT01155453|"     This is an open label, dose finding, phase Ib clinical trial to determine the maximum     tolerated dose (MTD) and /or recommended phase II dose (RP2D) and schedule for the PI3K     (Phosphatidylinositol 3-Kinase) inhibitor BKM120 given in combination with the MEK inhibitor     GSK1120212 in patients with selected, advanced solid tumors. The focus will be on tumors with     RAS/RAF mutations and on triple negative breast cancer.      Both study drugs will be administered once daily orally on a continuous schedule, a treatment     cycle is defined as 28 days.      Cohorts of at least 3 and up to a maximum of 6 patients eligible for the dose-determining set     will be enrolled per dose combination below the MTD. The MTD is defined as the highest drug     dosage not causing in the first cycle of treatment medically unacceptable, dose-limiting     toxicity (DLT) in more than 33% of the treated patients.. At least 12 patients will be     required at MTD and 6 patients at RP2D level to allow the evaluation of the combination's     safety and pharmacokinetics or pharmacodynamics.      Upon declaration of MTD and/or RP2D, patients will be enrolled to an expansion part of the     study, to further assess safety, as well as to learn more about the efficacy of the study     drug combination.        -  Expansion Arm 1 will consist of approximately 15 patients with RAS or BRAF mutant          advanced NSCLC        -  Expansion Arm 2 will consist of approximately 15 patients with RAS or BRAF-mutant          ovarian cancer        -  Expansion Arm 3 will consist of approximately 15 patients with RAS or BRAF-mutant          pancreatic cancer   "
251987|NCT01155466|"     When a patient with Parkinson's disease (PD) is initially treated with L-dopa or dopamine     agonists, the symptoms of PD improve or disappear. After several years of taking L dopa or     dopamine agonists, patients notice that their PD medications wear off sooner than when they     first started taking them. This wearing off is characterized by the return of symptoms     (i.e., tremor, slowness, and rigidity) and may occur over the course of a few minutes to an     hour. When a patient's PD symptoms have returned, the patient is said to be in the off     state. When the patient takes another dose of medication, and his/her PD symptoms improve or     resolve, the patient is said to be in the on state. Antagonism of adenosine Type 2a     receptors (A2a) may provide relief of PD symptoms. This trial will test the hypothesis that     A2a receptor antagonism can lead to improvement in the function of PD participants taking a     stable dose of L-dopa, as measured by a reduction in off time.   "
252000|NCT01155635|"     The purpose of this study is to evaluate whether beta-blocker therapy improves 6-year     clinical outcomes in patients with ST-segment elevation acute myocardial infarction and     preserved left ventricular ejection fraction after primary percutaneous coronary     intervention.   "
251990|NCT01155505|"     This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the     maximum Tolerated Dose (MTD) of the combination of CC-5013 (Lenalidomide)and paclitaxel in     patients with advanced solid tumors.      Other purposes of the study are:        1. Define the safety profile of the CC-5013 and paclitaxel given in combination        2. Define the pharmacokinetics of CC-5013 and paclitaxel given in combination        3. Define the pharmacodynamic effects of the combination by monitoring potential biomarkers          of the different biological activities of each component of the regimen        4. Define the optimal biological dose (OBD) and the dose recommended (RD) for phase II          studies in selected tumor types (breast, ovary, prostate, NSCLC)        5. Collect evidence of antitumor activity in selected tumor types   "
251991|NCT01155518|"     Low testosterone production, known clinically as hypogonadism, appears to be common     complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known     to be associated with decreased muscle mass, increased fat mass, increased inflammation and     decreased fertility. In this grant, the investigators propose to study the effects of having     low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat     and muscle mass at specific areas of the body 3) expression of mediators of inflammation in     the blood 4) semen quality. This study will compare diabetic men (with or without     hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug     that increases testosterone and sperm production) or testosterone in men with diabetes and     hypogonadism. The investigators hope that this project will help us understand the state of     hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us     insights into treatment of this condition. With the rising prevalence of type 2 diabetes in     the young, this project may have implications for public health.   "
251992|NCT01155531|"     The hypothesis of this study is that up to 150 mg of sertraline and up to 3 mg of telenzepine     will be safe, tolerable, and have the effect of suppressing appetite, when taken in     combination daily by mouth by healthy, overweight, adult men and women.      In this study, up to 12 people will be assigned to one of 4 groups: A, B, C, and D, and will     receive 0, 50, 100, or 150 mg of sertraline per day. People in Groups B, C, or D will receive     an initial dose of 50 mg sertraline. People in Groups C and D will receive an additional 50     mg of sertraline per week.      Up to 10 people from each group who were able to tolerate their sertraline dose for at least     5 days will begin taking 50 mg of sertraline plus doses of telenzepine that will increase     from 1 mg to 2 mg to 3 mg over a 7-day period (they will receive each combination). On the     day before they begin taking this combination of drugs, their appetite will be evaluated (on     a visual scale of 0 to 100) before and after 3 meals.      The appetites of each person, assessed by the visual scale, will be evaluated on the last day     of the period (Day 7) before and after 3 meals of each combination treatment, while they are     staying in the research unit. The amount of food they eat will be determined.      Based on safety and tolerability assessments of individuals, and of the previous groups who     received lower doses of the combination of drug, a decision will be made whether to further     increase the dose of these drugs.      Since the appetites of each person will be evaluated on the last day of the period (Day 7)     before and after 3 meals of each combination treatment, people in this study will stay in the     research unit for approximately 2½ days, starting on Day 6 of their previous treatment, so     appetite evaluations can be made on Day 7 after a fixed meal in the evening of Day 6. These     people will continue the stay in the research unit when they begin each telenzepine dose     increase, so a 24 hour safety observation may be made immediately after the increase.      After the final doses of telenzepine have been received, people in Groups C and D will     continue to receive sertraline 50 mg per day for an additional 7 days or until the study     physician decides when sertraline should be discontinued. People will return to the study     unit for final visit, 2 weeks after they have received their last sertraline dose.   "
251993|NCT01155544|"     This project focuses on the under-researched group of individuals who develop psychotic     episodes of short duration (less than four weeks) while using substances. This includes     individuals diagnosed with psychotic disorder not otherwise specified (PNOS) or     substance-induced psychotic disorder (SIP) AND substance abuse or dependence. Very little is     known about the most appropriate maintenance/relapse prevention management of these subjects.     These individuals are not diagnosed with a primary psychosis because psychotic symptoms are     too short-lived or non-specific, the onset of substance use precedes the onset of psychotic     symptoms and the subject has not experienced sufficient psychotic symptoms in the absence of     substance use. However, previous studies have shown that they are at high risk of recurrence     of psychotic symptoms. Thus, this project will assess the efficacy of the second-generation     antipsychotic aripiprazole for maintenance treatment of subjects who had a recent psychotic     episode of short duration associated with substance use. The investigators will compare     aripiprazole and placebo for preventing the recurrence of psychotic symptoms and decreasing     substance use during a 6-month maintenance phase.   "
251994|NCT01155557|"     This study aims at examining muscle strength capacity in neck and shoulder muscles in     children and adolescents with and without tension-type headache, and furthermore examining     the effect of a 10 week specific strength training programme for neck and shoulder muscles     compared to a multi-disciplinary approach in 10 weeks.   "
251995|NCT01155570|"     The survey will be conducted with regard to the following aspects of treatment with Humira     (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug:        -  unknown adverse drug reactions, especially clinically significant adverse reactions        -  incidence and conditions of occurrence of adverse reactions in the clinical setting        -  factors that may affect the safety and effectiveness of Humira.   "
251996|NCT01155583|"     RATIONALE: Drugs used in chemotherapy, such as azacitidine and dexamethasone, work in     different ways to stop the growth of cancer cells either by killing the cells or by stopping     them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune     system in different ways and stop cancer cells from growing. Giving azacitidine together with     lenalidomide and dexamethasone may kill more cancer cells.      PURPOSE: This phase I/II trial is studying the side effects and best dose of azacitidine when     given together with lenalidomide and low-dose dexamethasone in treating patients with     relapsed or refractory multiple myeloma.   "
251997|NCT01155596|"     This is a Quasi-experimental research design. The subjects are limited in intensive care unit     within north medical center hospital. All subjects depend on ventilator and receive weaning     plans. Experimental group is weaning with the support of negative pressure ventilator .The     investigators collect basic personal variables in the questionnaire, APACHE Ⅱ scale, Dyspnea     scale and arterial blood gas analysis and ventilator weaning index. Compare experimental     group and control group data. Data will be Statistical analyzed by: descriptive statistics     (such as: mean, standard deviation, median, frequency, percentage) and inferential statistics     (such as: Independent T-test, Pair T-test, Mann-Whitney U test), P-value <0.05 will consider     to be statistically significant.   "
251998|NCT01155609|"     This pilot clinical trial studies L-lysine in treating oral mucositis in patients undergoing     radiation therapy with or without chemotherapy for head and neck cancer. L-lysine may lessen     the severity of oral mucositis, or mouth sores in patients receiving radiation therapy with     or without chemotherapy for head and neck cancer   "
252003|NCT01155674|"     Polymorphonuclear neutrophils, or granulocytes, are essential effector cells of the innate     immune system against bacterial infections. Their role in sepsis has been long established as     the primary phagocyte to clear the infectious process. In the early phase of sepsis, one     observes a massive recruitment of immature neutrophils from the bone marrow into peripheral     blood, the so-called band forms or left shift cells. Despite the daily clinical use of     neutrophil band forms count in the care of septic patients and their abundance in septic     blood, no information exists on the fate of these cells, nor on their capacity to mount an     efficient innate immune response. It is the goal of this proposal to study the fate and the     innate immune functions of immature neutrophils obtained in patients with early septic shock.     Immature neutrophils will be separated from mature neutrophils. The following functions will     be studied ex vivo in mature vs. immature neutrophils from a series of patients with severe     sepsis and septic shock: (1) surface expression of receptors of the innate immunity; (2)     production of inflammatory mediators and reactive oxygen species in response to bacterial     agonists; (3) chemotaxis; (4) phagocytosis of Gram-positive and Gram-negative bacteria; and     (5) ex vivo viability (life span) and resistance to apoptosis. Importantly, the investigators     have developed and mastered all in vitro assays and cell separation techniques necessary to     address and answer these important questions. This project will undoubtedly shed light on the     fate and function of a prominent leukocyte population circulating in patients with severe     bacterial infections and sepsis.   "
252004|NCT01155687|"     The assessment intends to investigate the efficacy of psychosocial counseling for the     treatment of help seeking individuals with psychosocial problems in Mazar-e-Sharif,     Afghanistan. Treatment was administered by local counselors who had received specific     education and training   "
252005|NCT01155700|"     The primary purpose of this study is to examine whether the geometric mean of serum free IgE     level at 24 weeks of the treatment period in Japanese pediatric patients (6 to 15 years of     age) reaches under 25 ng/mL (target level). The investigators will also assess how well PK/PD     data of Japanese children fit the global PK-PD modeling built from those of Caucasian adults     and children, and assess efficacy and safety data in Japanese pediatric patients which will     fulfill the Japanese health authority requirement for approval. Data obtained from the study     is intended to be used to support the registration of pediatric indication of omalizumab in     Japan.   "
252006|NCT01155713|"     This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and     the effect of food on the bioavailability of TKI258, in adult patients with advanced solid     tumor.   "
252007|NCT01155726|"     The purpose of this study is to explore the effect of masking on subjective ratings for two     daily disposable contact lenses.   "
252008|NCT01155739|"     Procalcitonin level used for determining length of antibiotic treatment in peritonitis and     intra-abdominal infections. Hypothesis is that length of antibiotic use can be shortened by     this method.   "
252009|NCT01155752|"     The hypothesis is that the intranasal use of Pulmozyme will decrease the severity of     sinusitis in Cystic Fibrosis and lead to an improved quality of life.   "
252010|NCT01155765|"     Clopidogrel administration is essential in patients undergoing percutaneous coronary     intervention, in patients with previous stroke, in patients under chronic hemodialysis via     fistulae and in patients with chronic atrial fibrillation if coumarin administration is not a     viable option. Patients with chronic renal failure present lower clopidogrel response     compared to those with normal renal function. Additionally, hemodialysis via the dialysis     filter causes a decrease in glycoprotein platelet receptors, potentially associated with     thienopyridine hyporesponsiveness. Clopidogrel resistant patients as assessed by VerifyNow     P2Y12(Accumetrics)will be randomized in 1:1 fashion to prasugrel 10mg/day or clopidogrel     150mg/day. On day 15±2 days a crossover directly to the alternate treatment group will be     carried out, without an interventing washout period. All patients will undergo platelet     reactivity assessment, documentation of major adverse cardiac events and documentation of any     serious adverse events(stroke, bleeding)at day 15 and day 30.   "
252011|NCT01155778|"     Sanfilippo syndrome, or Mucopolysaccharidosis (MPS) III, is a rare lysosomal storage disease     (LSD) caused by loss in activity of 1 of 4 enzymes necessary for degradation of the     glycosaminoglycan (GAG) heparan sulfate (HS) in lysosomes. The central nervous system (CNS)     is the most severely affected organ system in patients with MPS IIIA. In these patients     abnormal behaviors include, but are not limited to, aggression and excess motor     activity/hyperactivity that contribute to disturbances in sleep.Overall, individuals with MPS     IIIA have a marked developmental delay and significantly reduced lifespan of 15 years of age     on average.      The purpose of this study is to determine the safety and tolerability of rhHNS via ascending     doses administered via an a surgically implanted intrathecal drug delivery device (IDDD)     intrathecal (IT) route once monthly for 6 months in patients with MPS IIIA.   "
252012|NCT01155791|"     Selenium, in the form of inorganic Sodium Selenite, may be useful for treating existing     prostate cancer. This idea is based on data from our laboratory showing that 1) prostate     cancer cells are more sensitive to Selenium (Sodium Selenite)-induced apoptosis than normal     prostate epithelial cells, 2) Selenite induces significant growth inhibition of well     established prostate cancer tumors in mice at doses that have no detectable toxicity, and 3)     Selenite disrupts AR signaling, and that the inhibition of AR expression and activity by     Selenite occurs via a redox mechanism involving GSH, superoxide, and Sp1. Altogether, these     findings suggest that Selenium may be useful in a variety of potential indications in the     natural history of prostate cancer, including both hormone sensitive and castrate resistant     prostate cancer, as a single agent, or in combination with radiation, chemotherapy or     conventional hormone therapy. Selenite is a potential novel inhibitor of AR expression and     function in prostate cancer.   "
252054|NCT01156337|"     The study was aimed to verify the effects of Hypertonic saline solution (HSS) and a moderate     sodium (Na) restriction plus high furosemide dose in the short term (hospitalization time)     and a moderate Na restriction in the long term on readmissions and mortality in patients in     III NYHA class.   "
252040|NCT01156155|"     Periodontitis (PD) has been postulated to be a risk factor for the onset and progression of     rheumatoid arthritis (RA). Recent reports suggest that infection with Porphyromonas     gingivalis (P. gingivalis), a major oral pathogen in PD, could play a pivotal role in the     development RA. The objective of this study is to examine the relationship of PD and P.     gingivalis infection with the risk and severity of RA.   "
252013|NCT01155804|"     Introduction: randomized studies on programs implemented during pre-natal care that offer     information and physical activities preparing pregnant women for delivery are scarce in the     scientific literature. Objective: to evaluate the effectively of the Program for Preparation     of Pregnant Women for Delivery on the prevention of physical and psychological difficulties     and problems during pregnancy and delivery in nulliparous women participating in the program.     Subjects and methods: a randomized clinical single blind trial will be conducted with 192     pregnant nulliparous women allocated to participate or not of the program activities. The     women allocated to the study group will participate of physical and educational activities at     each pre-natal consultation and will receive orientation on the exercises they will perform     at their home. Participants of the non-interventional group will follow the habitual routine     care at the service. Participants will be selected among nulliparous low risk pregnant women     aged between 16 and 40 years old after the 20th week of gestation. Data analysis: will be     performing by intention to treat. For the continues variables the t-Student or Wilcoxon test     will be performing; for the categorical variables the tests x² or Fisher, and the risk     estimate will be estimated using a Relative Risk with 95% CI. ANOVA will be use for measures     between the groups and along time, and correlation tests for anxiety and physical activity     with gestational and perinatal variables.   "
252014|NCT01155817|"     PRIMARY OBJECTIVES:      Determine the safety and tolerability of nilotinib in steroid dependent / refractory cGVHD.      SECONDARY OBJECTIVES:      Determine the clinical efficacy of nilotinib in steroid dependent / refractory cGVHD.   "
252015|NCT01155830|"     This study proposes to quantify inflammatory cytokine profiles in three neonatal disease     states, namely, neonatal sepsis, infants with a congenital diaphragmatic hernia defect, and     infants suffering cardiopulmonary failure significant enough to require heart/lung bypass     treatment with extracorporeal membrane oxygenation (ECMO).   "
252016|NCT01155843|"     Asthma is a chronic disease that affects nearly 13% of adults in the U.S., causing     substantial impairment that is reflected in the tens of millions of missed days of work, and     doctors' and emergency room visits it leads to annually. Those who have asthma are twice as     likely to develop depression and anxiety, which are associated with more frequent and severe     asthma symptoms, especially in those under chronic stress. The project proposed here seeks to     understand the role of the brain in these associations and to evaluate the neural mechanisms     through which a safe, low-cost intervention, that influences the function of body via the     mind, may diminish the expression of asthma symptoms.   "
252017|NCT01155856|"     Introduction:      With the rapid development in technology telemedicine has become a tool with the potential to     improve and optimize the treatment of different diseases and to make diagnostics, treatment     and counseling possible over shorter or longer distances.      Home based telemedicine is a new method that leads to a series of important questions that     needs to be answered. This study is designed to answer questions concerning patient safety in     telehomecare, the patients´ quality of life, efficiency and a cost benefit analysis of     implementing this technology.      This study is about patients with chronic obstructive pulmonary disease (COPD) who are     admitted to the hospital with an acute exacerbation. Approximately 24 hours after admission     half of the patients are randomized to be admitted to their own home supported by telemedical     equipment while the other half remain admitted at the hospital (typically between 5-7 days).      Primary Aim:      To investigate if telemedical surveillance and treatment in the recovery period of an acute     exacerbation is just as safe as conventional admission of patients with COPD measured on     treatment failure.      Secondary Aims:      To evaluate if telemedical surveillance and treatment in the recovery period of an acute     exacerbation compared to conventional treatment of COPD:        1. Is comparable in reestablishing Forced Expiratory Volume in 1 second (FEV1).        2. Demands the same number of treatment days/time before discharge/cessation of telemedical          surveillance.        3. Is comparable in quality of life in the two groups of treated patients.        4. Have comparable adverse event profiles.        5. leads to a lower total cost in health services (health economical analysis)        6. Is possible to do for the patients (drop-outs because of the technical equipment or the          patient does not know how to use the equipment.)      7 Is better seen from the physician's perspective when it comes to:        1. The virtual patient contact / communication        2. Technology        3. The work process compared to the conventional work process        4. Time spent with the patient        5. Usability        6. Improvement potentials (the doctors view)           8. The equipment is satisfactory for the patient to use           Method           For this study a telemedical platform has been developed on which it is possible to          treat patients in their own homes. The platform consists of a videoconference part that          allows the patients to make contact to qualified medical staff and a technology part          that can transfer vital indicators of the patients´ health condition (lung function,          oxygen saturation, pulse etc.) 175 patients will be included with an expected drop-out          of 20 % or 35 patients. The patients will be equally recruited from two hospitals          (Frederiksberg and Herlev Hospital). All patients must have an exacerbation in their          COPD that requires hospitalization to be included in this study. Each patient          participates in the study for 6 months after discharge with follow-up at 1, 3 and 6          months.   "
252018|NCT01155869|"     Almost 200,000 veterans are homeless each night, about one-quarter to one-third of homeless     adults in the U.S. Half need treatment for a substance use disorder, usually alcohol     dependence, but sobriety is often required to access alcohol treatment and housing services.     A monthly injection of depot naltrexone is efficacious in reducing alcohol use, but it is     expensive and restricted in many VA Medical Centers. Oral naltrexone is more available but     seldom used because of adherence problems that limit effectiveness. This open-label pilot     study would compare the effect of depot versus oral naltrexone to help twenty homeless,     alcohol-dependent veterans decrease their drinking, achieve sobriety and qualify for housing     services. This study's findings could expand access to effective medication-assisted alcohol     treatment in the VA, and thus help homeless veterans with alcohol problems improve their     drinking, housing status, and appropriate use of health services.   "
252019|NCT01155882|"     The purpose of this study is to determine how effective Whipple at the Splenic Artery     (WATSA).   "
252020|NCT01155895|"     The objective of this study was to compare the single-dose relative bioavailability of Dr.     Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril     hydrochloride capsules, under fasting conditions.   "
252021|NCT01155908|"     The objective of this study was to compare the single-dose relative bioavailability of Dr.     Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril     hydrochloride capsules, under non-fasting (fed) conditions.   "
252022|NCT01155921|"     The purpose of this study was to assess the single-dose relative bioavailability study of 1     mg risperidone orally disintegrating tablets and (Risperdal M-TAB) under fasting conditions.   "
252023|NCT01155934|"     The purpose of this study was to assess the single-dose relative bioavailability study of 1     mg risperidone orally disintegrating tablets and (Risperdal M-TAB) under fed conditions.   "
252024|NCT01155947|"     The purpose of this study is to compare bioavailability in healthy, post menopausal women     subjects under fasting conditions.   "
252025|NCT01155960|"     The purpose of this study is to compare bioavailability in healthy, post menopausal women     subjects under fed conditions.   "
252026|NCT01155973|"     Background: High blood pressure (HBP) is a major risk factor for cardiovascular disease     (CVD). European hypertension and cardiology societies as well as expert committees on CVD     prevention recommend stratifying cardiovascular risk (CVR) using the SCORE method, the     modification of lifestyles to prevent CVD, and achieving good control over risk factors. The     EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of     a CVR visual learning method - the EDUCORE method - is more effective than normal clinical     practice in improving the control of blood pressure within one year in patients with poorly     controlled hypertension but no background of CVD.      Design & Method: Cluster randomized controlled clinical trial. Location: 22 primary health     care centres in Madrid. Participants: patients diagnosed as hypertensive (systolic >140 mmHg     and/or diastolic >90 mmHg) at least a year before, uncontrolled. Age: 40-65 year-old patients     who consent to take part. Sampling: randomized cluster assignment. Random allocation unit:     health care centre. Analysis unit: patient who match criteria. Size: 736 patients (368 each     arm. Measurements: Outcome variables: systolic and diastolic blood pressure (mmHg).     Cardiovascular risk level: SCORE. Measure of Adherence to treatment (Morisky-Green     questionnaire. Health related quality of life questionnaire MINICHAL. Smoking habits. Total     Cholesterol. Other variables: Gender. Age. Educational level. Physical activity in metabolic     equivalent (MET). Body mass index. Drug consume (cardiovascular line). Treatment changes and     nature of the change. Intervention: EDUCORE group (direct exhibition of their cardiovascular     risk with SCORE, visual images and documentation to the patients); Control Group: standard     practice care.   "
252027|NCT01155986|"     The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated     plaster in localized chronic post-operative neuropathic pain in comparison to placebo     plaster.   "
252028|NCT01155999|"     Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent     bacterial conjunctivitis of children.   "
252029|NCT01156012|"     The purpose of this study is to assess the efficacy and safety of T2345 versus active     comparator.   "
252030|NCT01156025|"     The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to     placebo in patients with acute adenoviral keratoconjuncivitis.   "
252031|NCT01156038|"     Atopy patch test in normal population   "
252032|NCT01156051|"     This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if     guanfacine extended release is able to improve nighttime sleep in children with ADHD -     associated insomnia while improving daytime ADHD symptoms. Male and female children with     diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty     staying asleep, or less than expected hours of sleep) will be recruited. After obtaining     informed consent and assent (when appropriate) and after discontinuation of excluded     medications, children will have evaluations of his or her sleep and evaluations confirming     the ADHD diagnosis. Children who successfully pass screening will be enrolled into the     double-blind, placebo-controlled, randomized investigation with 50% of participants receiving     guanfacine extended release and 50% of participants receiving matching placebo. Using a     flexible-dose optimization design based on ADHD symptom improvement and medication     tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At     the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires,     and sleep tests will be repeated and analyzed. The medication will be weaned over the course     of the following 3-10 days.   "
252033|NCT01156064|"     Confocal laser endomicroscopy (CLE) is a newly endoscopic device that enables microscopic     view of the digestive tract. The purpose of this study is to determine if confocal laser     endomicroscopy can improve detection of digestive disease include inflammation, dysplasia,     and early cancer, and if confocal laser endomicroscopy has competitive advantage, compared     with other device such as Narrow Band Imaging and Autofluoresecence Imaging.   "
252034|NCT01156077|"     This is an open-label, multi-center, two-part, parallel-design study to assess the PK,     safety, and tolerability of TR-701 FA and its active metabolite, TR-700, following a single     oral dose (Part A) or IV dose (Part B) of TR-701 FA in 12 to 17 year old adolescent patients.   "
252035|NCT01156090|"     The purpose of this study is to identify approximately 100 - 150 patients who have received     Vectibix (Panitumumab) in offices and clinics located in Tennessee, North Carolina, South     Carolina, and North Georgia from February 2004 - April 2009. Information regarding the     incidence and severity of hypersensitivity infusion reactions to Vectibix (Panitumumab)will     be captured. In patients who experienced hypersensitivity reactions, the following     information will also be collected: premedication, treatment cycle symptoms that were     experienced during chemotherapy, changes required in subsequent Vectibix (Panitumumab) or     chemotherapy treatment, and outcome of the hypersensitivity reaction.   "
252036|NCT01156103|"     This study will assess the impact of a national, community-based after-school program     promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular     risk factors among minority children. The investigators central hypothesis is that     established community-based programs, such as America SCORES, can reduce obesity and     cardiovascular risk among participants. The 1-year study followed 158 children from 6 public     schools, 3 of which were randomized to have SCORES and 3 to usual care after-school     program. Primary outcomes are change in body mass index (BMI), physical activity (measured by     accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test).     Cardiovascular outcomes include blood pressure, body composition (assessed using     bioelectrical impedance) and waist circumference. The investigators will also measure     academic outcomes.   "
252037|NCT01156116|"     Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and     diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure     (CPAP) has metabolic benefits. The objective of this study is to determine the effect of     8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.   "
252038|NCT01156129|"     This is a randomized controlled trial to assess ways to address post-operative ileus (POI) in     adult patients on the liver transplant service undergoing either liver transplant or     resection surgery. Patient who speak and understand English will be randomized into one of     three groups including a.)control group receiving standard therapy for post-operative ileus,     b.)group receiving standard therapy and acupressure bracelets, and c.)group receiving     standard therapy and sugar free gum four times daily.   "
252042|NCT01156181|"     Pregnancy rate may be affected by multiple factors such as embryo transfer techniques. Even     small differences in embryo transfer methods may affect pregnancy rates. There is an     inconsistency about the effect of the removal of cervical discharge on embryo transfer     outcomes. Some studies showed that cervical mucus removal before embryo transfer can increase     pregnancy rate, however the others could not find any significant effect about the removal of     cervical mucus on pregnancy or live birth rates. Given to the conflicting evidences, our     study aimed to determine whether the cervical discharge removal has positive effect on     pregnancy rate.   "
252043|NCT01156194|"     The homeopathic remedy consisting of Arnica and Bellis perennis have been shown in a previous     pilot study (n=33) to reduce blood loss during the third stage of delivery, when compared     with placebo treatment. The purpose of this study is to repeat the previous methodology, this     time on a larger population.      210 parturients will be randomized to one of three groups: Arnica montana C6 and Bellis     perennis C6 (n=70), Arnica montana C30 and Bellis perennis C30 (n=70), or double placebo     (n=70).   "
252044|NCT01156207|"     Heart failure is a major health problem worldwide. Optimal treatment of this disabling and     fatal condition may require functional characterization of the failed left ventricle (LV) and     its interaction with the arterial system. Part of the physiological significance of the     ventriculo-arterial coupling has been studied experimentally and clinically using the     framework of the ratio of effective arterial elastance (Ea) to end-systolic elastance (Ees),     with limited clinical applications.      From central ascending aorta to terminal arterioles, every segment of the arterial tree     contributes to the arterial loads that interact and impact LV performance in both systole and     diastole, leads to atrial and ventricular remodeling and hypertrophy, and results in the     development of heart failure. On the other hand, the ventricular systole is a complex     coordination of multi-directional myocardial fibers involving longitudinal contraction,     circumferential shortening, radial thickening, twist, and torsion, the so-called LV     deformations.      The purposes of the present study are to investigate the relationship between different     components of hemodynamic load or arterial abnormalities and different components of LV     myocardial deformations or regional LV function, the modulating effects of endothelial     progenitor cells (EPCs) on the ventriculo-arterial coupling, and the therapeutic effects of     aliskiren on the components of hemodynamic load and LV myocardial deformations and their     couplings. The investigators will also investigate whether the ventriculo-arterial coupling,     EPCs, and add-on therapy of aliskiren predict cardiovascular outcomes.   "
252045|NCT01156220|"     In this study the gender specificity of the effects of furosemide in female and male     volunteers will be investigated. The healthy volunteers receive 1. furosemide and 2.     aminohippurate sodium PAH as single dose. The main objective is gender-specific comparison     of the pharmacokinetic parameters of furosemide in relation to the effect of furosemide     (urinary excretion). Secondary objectives are the gender-specific comparison of renal and     systemic PAH clearance with the clearance of furosemide and the influence of various genetic     polymorphisms on the variability of furosemide pharmacokinetics.   "
252046|NCT01156233|"     In pediatric anesthesia it is very important to place the endotracheal tube into the right     position. This study compares two clinical location methods. The hypothesis means that the     two techniques have the same precision of the location of the tip position of a cuffed     MICROCUFF (Kimberly-Clark)endotracheal tube.   "
252047|NCT01156246|"     The purpose of this study is to determine whether treatment with a fixed dose combination     dapagliflozin/metformin tablet is affected by food.   "
252048|NCT01156259|"     The purpose of this study is to determine whether 30Gy Involved-field Radiotherapy (IFRT) is     as effective as 40Gy in the treatment of localized Diffused Large B cell Lymphoma (DLBCL)     when completing CR after chemotherapy.   "
252049|NCT01156272|"     The purpose of this study is to evaluate the safety and efficacy of the ATS 3f® Aortic     Bioprosthesis, Model 1000 (Equine Pericardial Bioprothesis) size 19mm in a patient population     undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement     of a failed prosthesis.   "
252050|NCT01156285|"     Acute anterior uveitis (AU) is a common reason for attendance at ophthalmic outpatient     clinics. The painfulness and the fear of a transient or even persistent loss of vision may     markedly reduce the individual's subjective well-being and pose a psychological burden.      This study will test the hypothesis that during an attack of AU the patient experiences a     marked reduction in psychological and physical well-being.      Prospective, hospital-based epidemiologic study using a patient questionnaire with     standardized psychological tests and a pain scale.   "
252051|NCT01156298|"     Phase IV, multi-center, non-treatment, observational, registry study to determine long term     effects of AVONEX® therapy on EDSS, MRI, QoL, and cognition.   "
252052|NCT01156311|"     The primary objective of the study is to evaluate the safety and tolerability of BG00012     (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer     acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).   "
252053|NCT01156324|"     The goal of this study is to determine the impact of an online stress management program,     which combines stress reduction and prevention strategies with personal care products/rituals     which have relaxation properties, on pregnancy rates and psychological distress in women     undergoing IVF for the first time.   "
252055|NCT01156350|"     To date, no curative option exists for patients with relapsed or refractory stage IV     neuroblastoma after previous autologous stem cell transplantation. Our preliminary results of     RIC allo-HSCT (protocol RICE) indicate the feasability and low toxicity of allograft in     heavily pre-treated children. Furthermore RIC SCT and immunomagnetic CD3/CD19 graft depletion     may allow HHCT with lower toxicity and faster engraftment. CD3/CD19 depleted grafts not only     contain CD34+ stem cells but also graft-facilitating cells, CD34- progenitors, dendritic and     natural killer cells which may allow stable engraftment and participate to GvT effect.      After haploidentical stem cell transplantation anti tumour activity exerted by donor derived     NK cells could be stimulated by NK cells injections. Those effects may help to reduce the     relapse rate and to impove the outcome of those patients. The investigators prospectively     evaluated engraftment and immune reconstitution.   "
252112|NCT01157091|"     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.      PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works in treating     patients with stage IV kidney cancer.   "
252056|NCT01156363|"     This open label, single arm study will assess the efficacy for long-term maintenance of     haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin     beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term     haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera     for 6 months. Target sample size is <200 patients.   "
252057|NCT01156376|"     This study is 25 days long. People participating in this study will be asked to brush their     teeth two times a day. People will be assigned to a mouthwash and will rinse four times a day     at the site for five days. A dentist or dental hygienist will look at the mouth, teeth,     tongue and gums to make sure the mouthwash does not irritate the mouth. After Day 5 of the     study, people will continue to brush two times a day and will return on Day 24 to have their     mouth looked at again. People without irritation in their mouth will rinse 4 times a day at     the clinical site. People will return to the clinical site the next day and have a final oral     exam in which the dentist or dental hygienist will look at the mouth for irritation.   "
252058|NCT01156389|"     Pyronaridine/ artesunate (Pyramax) is an antimalarial therapy which has been demonstrated to     be a safe and effective treatment in patients with Plasmodium falciparum and vivax malaria.      This drug interaction study is intended to investigate if there is any interaction between     Pyramax and the protease inhibitor ritonavir in healthy subjects using ritonavir as a probe     substrate.   "
252059|NCT01156402|"     The purpose of this study is to evaluate the efficacy of a culturally-appropriate childhood     obesity intervention with Hispanic families. The program aims at preventing childhood obesity     by targeting parents to address nutrition, physical activity, and sedentary behaviors in     their children.   "
252060|NCT01156415|"     The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under     the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder     over a 52-week open-label phase.      Cohort I is restricted to include patients who have completed a previous Novartis agomelatine     (178C) Double-blind study.      Cohort II will include de-novo patients (those who did not participate in a previous     agomelatine 178C study) and will only be open for a limited time span ranging from     approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.   "
252061|NCT01156428|"     This study will evaluate in patients with kidney disease, the role that certain inflammatory     and immune mediators play in promoting kidney damage. The investigators hypothesize that     certain mediators, (identified in the serum, urine and renal biopsy tissue), of patients with     a variety of different renal disease states will provide information regarding their clinical     course and that inflammatory and immune patterns in the serum and urine of patients with     kidney disease may yield predictive diagnostic information in place of a renal biopsy. The     ability to detect and quantify these mediators may lead to earlier detection and treatment of     kidney disease in order to prevent kidney failure and the requirement for renal replacement.      The study will evaluate serum, blood and urine collected over a one year period post kidney     biopsy for the presence of inflammatory or immune mediators, which will be correlated with     kidney pathology findings (gene signatures). These gene signatures will be compared to     normal control specimens obtained from donor transplant kidneys or from normal kidney     tissue obtained from patients who require their entire kidney removed for a tumor.   "
252062|NCT01156441|"     The pilot prospective randomized trial is designed to determine the safety and feasibility of     enrolling patients to surgically correct residual Mitral Regurgitation (MR) following     Percutaneous Coronary Intervention (PCI) for Myocardial Infarction (MI) verses ongoing     medical management of MR. The investigators hypothesize that if moderate MR is corrected in     this patient subset, the patients will have improved outcomes as measured by decreased number     of major adverse cardiac events, including death, congestive heart failure requiring     hospitalization, atrial fibrillation, deterioration of New York Heart Association (NYHA)     functional status and improved quality of life.   "
252063|NCT01156454|"     X-ray mapping of sentinel lymph nodes and/or axillary tissue will assist pathologists in     their ability to identify the number and location of lymph nodes as well as more accurately     section lymph nodes contained in surgical specimens.   "
252064|NCT01156467|"     The purpose of this study is to find out, whether it is possible to improve the ventilatory     care of premature infants by using Neurally adjusted ventilatory assist (NAVA).      The study hypothesis is that by using NAVA-technology and/or by monitoring Edi-signal (the     electrical signal of diaphragm), it is possible to accomplish ventilatory care to premature     infants more individually.   "
252065|NCT01156480|"     Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant     problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an     inflammatory necrosis of the bowels, to date no study has examined the effect of     anti-inflammatory therapy on this dreaded disease once it is diagnosed. The investigators     propose a multi-center, randomized, placebo-controlled, double-blinded pilot study to examine     the effect of hydrocortisone in infants diagnosed with stages II and III NEC. The     investigators will follow C-reactive protein (CRP) levels as a marker of systemic     inflammation for the primary outcome in this study.   "
252066|NCT01156493|"     Premature infants fed with a protein hydrolyzed formula will have better tolerance needing     shorter time to achieve full feeds when compared to those fed with an intact protein formula.   "
252067|NCT01156506|"     The study seeks to gain knowledge about new and of alternative ways of organizing ostomy     training based on informants' own experiences of life with a stoma.      The study is designed and conducted as qualitative focus group interviews with three     different groups of patients with enterostomas (5-8 in each group): a) people with permanent     enterostoma due to cancer, 2) people with permanent enterostoma due to non-cancer and 3)     people with a temporary ileostomy.   "
252068|NCT01156519|"     The main objective of the study is to assess the sensitivity of the salivary cortisol dosage     at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone     suppression test (Suppression of serum cortisol <1.8 μg/dL ) as the reference method for the     detection of ACIC in obese subjects   "
252108|NCT01157039|"     The investigators hypothesize that glutamine significantly reduces the incidence and severity     of peripheral neuropathy in patients receiving oxaliplatin for metastatic colorectal cancer,     decreases the need for dose reduction of oxaliplatin, and it does not impair oxaliplatin     efficacy or pharmacokinetics.   "
252070|NCT01156545|"     The investigators hypothesized that simvastatin may enhance sensitivity to BIBW 2992 in     non-adenocarcinoma that is relatively resistant to TKIs. Based on these data, the     investigators will research the effectiveness comparing BIBW2992, an irreversible EGFR-TKI,     plus simvastatin with BIBW2992 alone in the setting of a randomized phase II study in     previously treated patients with advanced non-adenocarcinomatous non-small cell lung cancer     (NSCLC).   "
252071|NCT01156558|"     Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of     severe bone loss by allowing rigid internal fixation and proper alignment of the extremity     and components.   "
252072|NCT01156571|"     The study is designed to compare the efficacy and safety profile of cangrelor to standard of     care in patients require percutaneous coronary intervention (PCI).   "
252073|NCT01156584|"     This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of     increasing doses of Toca 511, a Retroviral Replicating Vector (RRV), administered to subjects     with recurrent high grade glioma (rHGG) who have undergone surgery followed by adjuvant     radiation therapy and chemotherapy. Subjects will recieve Toca 511 via stereotactic,     transcranial injection into their tumor. Cohort 7 & 9 will receive Toca 511 as an intravenous     injection given daily for 3 & 5 days respectively. Approximately 3-4 weeks following     injection of the RRV, treatment with Toca FC will commence and will be repeated approximately     every 6 weeks until study completion or enrollment in the continuation study.   "
252074|NCT01156597|"     Metabolic defects contributing to the development of type 2 diabetes (T2D) are relative     insulin insufficiency and insulin resistance that are associated with a cluster of     abnormalities that increase the risk for cardiovascular disease including dyslipidemia,     inflammation, hemodynamic changes and endothelial dysfunction. The dyslipidemia associated     with T2D is characterized by elevated triglycerides and decreased high-density     lipoprotein-cholesterol (HDL). The ability of the insulin sensitizing agent pioglitazone     (ACTOS®) , to improve hyperglycemia in subjects with T2D is now well established.     Pioglitazone functions as a PPAR-γ (peroxisome proliferator-activated receptor gamma)     agonists and this class of drugs have demonstrated several other potential benefits, beyond     glucose homeostasis. Specifically pioglitazone can improve diabetic dyslipidemia by     increasing HDL cholesterol and lowing triglycerides. A potential beneficial effect on reverse     cholesterol transport may be mediated by the increased HDL levels. This proposal aims to     examine the effect of PPAR-γ activation by PIO on various aspects of reverse cholesterol     transport by testing the hypothesis that PIO treatment affects key steps in the reverse     cholesterol transport pathway either directly, through induction of protein expression, or     indirectly, by altering HDL structure and composition leading to increase cholesterol flux     through this pathway.   "
252075|NCT01156610|"     The objectives of this project are to develop and evaluate a multi-level approach to tobacco     treatment for low-SES and minority patients. The components of this intervention would     include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco     treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and     integration of this program with both an individual's primary care physician through an     electronic health record (EHR), as well as referral to community resources to address the     socio-contextual barriers to tobacco cessation. To achieve these objectives, this     intervention will test an innovative model of systematic outreach to low-SES and minority     smokers using systematic phone outreach (including cell phones which are particularly     prevalent among minority and low-SES groups), coordinated with the PCP, using both a     cost-effective technology and a dedicated tobacco treatment specialist to increase smoking     cessation in these populations. The proposed intervention will have multiple levels of     influence (patient, PCP) and provide linkages to community resources. If successful, this     model could be generalized to other health systems with an EHR, which are increasingly being     promoted to improve the safety and quality of health care.      Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment     program for low-SES and minority smokers can reach these patients to increase quit rates and     use of tobacco treatment effectively.      Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized     treatment program for low-SES and minority smokers can be adopted across a variety of     practice settings and be consistently implemented across diverse patient populations.   "
252076|NCT01156623|"     In lung cancer with enlarged or non-enlarged mediastinal lymph nodes, contrast-enhanced     computed tomography (CT) and Positron emission tomography (PET) scan frequently show     discrepancy in tuberculosis-endemic area. Endobronchial ultrasound guided transbronchial     aspiration (EBUS-TBNA) with ability of real-time nodal sampling possibly improves the nodal     diagnosis.      The purpose of this study is to compare the accuracy of nodal diagnosis of contrast-enhanced     CT and PET scan with and without EBUS-TBNA, this study will be performed.   "
252077|NCT01156636|"     Prevalence of heart failure (HF) with left ventricular (LV) diastolic dysfunction and     preserved ejection fraction (EF) (HFpEF) is increasing. Prognosis worsens with development of     pulmonary vasoconstriction and hypertension (PH) and right ventricular (RV) failure. The     investigators aimed at modulating pulmonary vascular tone and RV burden in HFpEF due to high     blood pressure (HBP), by using the phosphodiesterase-5 (PDE5) inhibitor sildenafil.   "
252078|NCT01156649|"     Obstructive sleep apnea is a problem for a large number of children and can result in     problems with thinking patterns, behaviors and sleep if left untreated. Little is known about     how positive airway pressure (PAP) therapy might help children who need treatment for     obstructive sleep apnea. We will investigate how PAP therapy might be able to improve     thinking patterns, behavior and sleep problems in children with obstructive sleep apnea.   "
252079|NCT01156662|"     The present study was designed to investigate whether the thrombus aspiration using Export     Aspiration Catheter (Medtronic Corporation, California, USA) during primary percutaneous     coronary intervention (PCI) in acute myocardial infarction improve clinical outcomes.   "
252080|NCT01156675|"     The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™     Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are     suffering from lumbar spinal stenosis at one or two contiguous levels.   "
252109|NCT01157052|"     The investigators hypothesize that Ca2+/MG2+ infusions will not have a significant effect on     oxaliplatin pharmacokinetics.   "
252082|NCT01156701|"     In response to the European regulatory authorities, GSK is conducting a post-marketing     observational study to assess the efficacy of Relenza when used as prophylaxis against     influenza.      SPECIFIC AIMS        1. Determine the frequency of patients who received Relenza from October 2006 through April          2009, and among them the number who have no concurrent diagnosis of influenza, i.e.,          those receiving Relenza for prophylaxis, and among these the number who have a family          member with a medical visit for influenza within three days preceding the above          indentified patient's dispensing of Relenza. This is to determine the feasibility of          conducting detailed analysis.        2. If analysis is feasible then tabulate the frequency of influenza-like-illness and          respiratory outcomes in users of prophylactic Relenza and their family members and in          family members of persons using Relenza for the treatment of influenza (i.e., index          cases).        3. If analysis is feasible then estimate the direct effect of prophylactic Relenza on the          occurrence of influenza-like-illness and respiratory outcomes, the secondary effect of          Relenza treatment of influenza on susceptible family members, and the total effect of          Relenza (treatment plus prophylaxis).      METHODS Overview of Study Design This is an analysis of the 30-day risk of influenza-like     illness and respiratory outcomes in persons for whom some household members (index cases)     have had a medical visit associated with a diagnosis of influenza. The exposed individuals to     the index case will be categorized into one of four cohorts according to whether the exposed     person received prophylactic Relenza or no antiviral treatment and by whether the index     family member with a diagnosis of influenza received antiviral treatment.      Estimates of the direct effect of Relenza prophylaxis, the indirect effectof preventing     disease in susceptible family members, and the total effect of disease reduction when both     index cases and susceptible family members are treated will be obtained from different     comparisons between cohorts, as outlined below.      The research will cover the first three influenza seasons during which Relenza has been     indicated for prophylactic use in the United States. These will be from October through April     of 2006-2009.   "
252083|NCT01156714|"     This study compares the effects treadmill exercise, computerized cognitive training, or the     combination of the two on executive function, dual-task performance, and performance on     several Instrumental Activities of Daily Living (IADLs).   "
252084|NCT01156727|"     This project added an evaluation/research component to an existing peer outreach program,     implemented for over 1100 soldiers in the Michigan Army National Guard. The study aims were     to: 1) evaluate the implementation of the B2B program to inform ongoing program modifications     and facilitate future dissemination efforts, 2) assess whether the B2B program increases     mental health and substance use treatment initiation and treatment retention among returning     National Guard soldiers, and 3) explore whether the B2B program improves mental health     symptoms, deceases hazardous alcohol use, and improves soldier well-being.   "
252085|NCT01156740|"     The purpose of this study was to compare the microbiological effects of two different     treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day     daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource     settings. This study was a prospective multi-center randomized active control treatment     trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin     treatment is at least as effective as the currently given IM BPG treatment.   "
252086|NCT01156753|"     The main purpose of this study is to see whether CDX-011 is effective in treating patients     who have advanced breast cancer that makes a protein called glycoprotein NMB (GPNMB), and who     have already received (or were not candidates for) all available approved therapies for their     breast cancer. This study will also further characterize the safety of CDX-011 treatment in     this patient population.   "
252087|NCT01156766|"     The number of osteoporotic fractures, among which the fractures of the lower extremity of the     radius (16 % of fractures seen in emergencies) is going to increase. Several surgical     techniques are described in particular locking plates and intrafocal pinning techniques.      The aim of the study is to compare (X-ray assessments and functional outcome) these two types     of treatment by using a prospective, randomised multicentric analysis.   "
252088|NCT01156779|"     This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to     characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects   "
252089|NCT01156792|"     The primary objective of this study is to evaluate the efficacy and safety of adding     GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone     propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects > or     = 12 years of age over the course of 6 weeks treatment.      The secondary objectives are to undertake an exploratory analysis of the efficacy and safety     of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice     daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate     the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects >     or = 12 years of age over the course of 6 weeks treatment.   "
252100|NCT01156935|"     Previous studies report low levels of mood and of quality of life among cancer patients.     Laugh has been proved to improve mood and immune system function. The investigators propose     to assess in a prospective randomised case-control study the affects of laugh-yoga     intervention on mood levels and quality of life among cancer patients in a cancer clinic. The     main hypothesis is that patients in laugh-yoga group will report higher mood and quality o     life levels after intervention in comparison with no-intervention group. The second     hypothesis is that immune system is the mediator of the effects of laugh-yoga intervention on     mood and quality of life.   "
252101|NCT01156948|"     To compare the impact of 400-microgram self-administered vaginal versus self-administered     oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to     outpatient hysteroscopy.   "
252302|NCT01158209|"     The purpose of the study is to determine the Human Papillomavirus (HPV) prevalence and HPV     type distribution among women aged >= 18 years, attending out-patient health services for     gynaecological examination and who agree to HPV testing in Egypt .   "
252090|NCT01156805|"     ABSTRACT Objective: to evaluate the efficacy of an intervention on food habits and physical     activity in school-age children.      Methods: a two-year cluster-randomised prospective study with two parallel arms was used to     evaluate an intervention programme in children in their first year of primary schooling (5-6     years of age) in schools in the city of Granollers. The intervention consisted of the     promotion of healthy eating habits and physical activity by means of the educational     methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end     of the study (2006 and 2008) the weight and height of each child was measured in situ, while     the families were given a self-report physical activity questionnaire and the Krece Plus     quick test.      Results: two years after the beginning of the study, the BMI of the children in the control     group was 0.89 Kg/ m2 higher than that of the intervention schools. The intervention reduced     by 62% the prevalence of overweight children. Similarly, the proportion of children that ate     a second piece of fruit and took part in an after-school physical activity increased in the     intervention group. In the control group, the weekly consumption of fish was reduced.      Conclusion: the educational intervention in healthy eating habits and physical activity in     the school environment together with the involvement of the family could contribute to lessen     the current increase in child obesity in our setting.   "
252091|NCT01156818|"     Karmel Sonix Ltd has developed the Personal WheezoMeter a hand-held pulmonary sounds analyzer     that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence     of wheezing. When used to monitor conditions such as asthma, this device should be used under     the direction of a physician or licensed healthcare professional. The device is intended for     use with pediatric and adult patients in both home and clinical settings.      The purpose of the study is to determine whether Wz% and change in Wz% correlate with     symptoms and change in symptoms at least as well as FEV1 and change in FEV1.0. Additional     information to be obtained from the study will be to determine whether there is a symptom     threshold at which a patient seeks rescue medications and if so, to determine the value of     Wz% and FEV1.0 at this point (Wz%, FEV1.0 thresholds). The study will also provide     information on the within patient and whole group correlations between Wz% and FEV.   "
252092|NCT01156831|"     The purpose of this study is to determine the locoregional control in PET/CT based     radiotherapy treatment planning in the treatment of esophageal cancer patients.   "
252093|NCT01156844|"     This study assessed the bronchodilator efficacy of three different regimens of indacaterol in     patients with asthma   "
252094|NCT01156857|"     This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once     daily for 3 months, blinded towards the administration of progestin or placebo after end of     PGL4001 treatment.   "
252095|NCT01156870|"     Primary Objective:      To determine the maximum tolerated dose (MTD) of SAR566658      Secondary Objectives:        -  To characterize the safety profile of SAR566658        -  To evaluate the pharmacokinetic profile of SAR566658        -  To assess the potential immunogenicity of SAR566658        -  To assess preliminary antitumor activity        -  To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using          midazolam        -  To assess safety in the alternative schedules of SAR566658 administration   "
252097|NCT01156896|"     The primary study hypothesis of the investigators is that administration of an iron     supplement between meals at a dose like that used in the Pemba trial (~1 mg Fe/kg) during P.     falciparum parasitemia will increase plasma non-transferrin-bound iron. A key subsidiary     hypothesis is that iron administered with meals in amounts used in food fortification (~0.1     mg Fe/kg) will not produce plasma non-transferrin-bound iron.      This research will be carried out at the Hospital for Tropical Diseases, Mahidol University,     Bangkok, Thailand. The studies are intended to help understand how giving iron and folic acid     to preschool children in Pemba, Zanzibar, Tanzania, (the Pemba trial) in the doses     recommended by the World Health Organization, could have resulted in an increase in     hospitalizations and deaths. The investigators will examine the most likely explanation, that     the dose of iron supplements used in the Pemba trial produced iron in the blood not bound to     the usual carrier for iron (a protein called transferrin), that is called     non-transferrin-bound iron, abbreviated as NTBI. In children with malaria, this NTBI might     favor the growth of malarial parasites or other causes of infection. At present, no studies     have been carried out to see if NTBI is present after giving iron to patients with malaria.     Using non-radioactive forms of iron (called stable isotopes), the investigators will study     iron absorption and NTBI after giving a single dose of iron (like that used in the Pemba     trial) one day after treatment for malaria has been started, while patients still have     malaria parasites in the blood, and then again two weeks later, after the malaria has been     cured. The investigators will study adults admitted to the Hospital for Tropical Diseases in     Bangkok, Thailand, with malaria. For reasons of safety, the investigators have chosen to     study adults in the hospital rather than children living in an area like Pemba but the     results should also apply to children. The outcome of this research will help us design ways     of safely giving iron in malarious areas to adults and children to prevent or treat iron     deficiency.   "
252098|NCT01156909|"     Based on pilot patient observations, and experience from the prior study KTS-1-2008, the     investigators anticipate that chronic fatigue syndrome patients may benefit from B-cell     depletion therapy using Rituximab induction with maintenance treatment.      The hypothesis is that at least a subset of CFS patients have an activated immune system     involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.   "
252099|NCT01156922|"     Based on pilot patient observations, and experience from the prior study KTS-1-2008, the     investigators anticipate that severely affected chronic fatigue syndrome patients may benefit     from B-cell depletion therapy using Rituximab induction with maintenance treatment.      The hypothesis is that at least a subset of chronic fatigue syndrome (CFS) patients have an     activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may     alleviate symptoms.      An approved amendment (April 15th 2011): the study will be extended with up to 5 patients.     For up to 5 patients in the study, standard plasma exchange may be performed 2-3 weeks prior     to start of B-lymphocyte depletion using Rituximab (as in the protocol).      Approved amendment (December 2011): for patients with gradual improvement in CFS/ME symptoms     after 12 months follow-up, but not having reached a clear response, up to 6 additional     Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months     period.   "
252118|NCT01157169|"     The object of this study is to compare the rate and extent of absorption of an     investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr     Laboratories, Inc. to an equivalent oral dose of the commercially available reference     product, Subutex® manufactured by Reckitt Benckiser, following and overnight fast of at least     10 hours.   "
252102|NCT01156961|"     This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in     combination with paclitaxel as first-line treatment in patients with locally recurrent or     metastatic Her2-negative breast cancer. Patients will receive Avastin, either 10 mg/kg     intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. Correspondingly, paclitaxel     will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175     mg/m2 on day 1 of every 21-day cycle. Anticipated time on study treatment is until disease     progression or unacceptable toxicity occurs.   "
252103|NCT01156974|"     Trained lay persons (care guides) working with chronic disease patients and their providers     can help outpatients with diabetes, hypertension, and congestive heart failure achieve     standard clinical care goals   "
252104|NCT01156987|"     Today's medical imaging methods have insufficient specificity for reliable differentiation     between benign and malignant breast lesions in patients. Pathologic evaluation is currently     the only way to obtain a definitive diagnosis. This research will use a novel method of     magnetic resonance imaging (MRI), Sweep Imaging with Fourier Transform (SWIFT), at a very     high magnetic field (4 Tesla) to distinguish malignant from benign breast lesions. This     research will reveal whether the SWIFT sequence bears new capabilities in medical imaging for     breast cancer diagnosis.   "
252105|NCT01157000|"     The purpose of this study is to evaluate the absolute oral bioavailability (how fast and how     much study drug is absorbed in the body) of a single 300-mg oral dose of canagliflozin in     healthy male volunteers.   "
253367|NCT01172145|"     This study examined the effects of modafinil on apathetic symptomatology, performance of     activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's     disease (AD).   "
252113|NCT01157104|"     This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug     interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two     drugs are administered in combination in healthy participants.   "
252114|NCT01157117|"     Food allergy affects up to 4% of the U.S. population and is most common in young children.     Milk allergy is the most common cause of food allergy in infants and young children, and     usually develops in the first year of life. There is no treatment for food allergy and the     current standard of care for milk-allergic individuals is the avoidance of milk-containing     products. Research is underway to identify potential therapeutic strategies to reduce or     eliminate the adverse effects experienced by milk-allergic individuals when they consume     milk-containing products.      Several studies have suggested that milk-allergic children who receive milk protein oral     immunotherapy (OIT) may become desensitized to milk, resulting in short term protection     against accidental ingestion of milk products. However, these children did not develop     tolerance, which is long term protection even after milk immunotherapy is stopped. A     potential strategy to induce tolerance to milk uses milk in combination with Xolair®     (omalizumab). Xolair consists of anti-IgE molecules that attach to IgE, the major antibody     involved in allergic reactions. The goal of this clinical trial is to see whether Xolair® in     combination with milk protein OIT is safer and more effective than OIT alone in inducing     tolerance to milk and milk products. Participants will be administered a double blind,     placebo controlled milk challenge at various time points in the study. If desensitization is     achieved participants will be tested for tolerance at a certain time point after stopping     treatment.   "
252115|NCT01157130|"     The proposed study compares the outcomes of a physical activity intervention begun at     diagnosis, continuing through active cancer treatment and into six months of survivorship     compared to the outcomes of a control group receiving limited information on activity.   "
252116|NCT01157143|"     The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in     injected tissue, at injection site, after Intra Muscular (IM) administration of increasing     single doses of NV1FGF.      Secondary objectives :        -  To evaluate the safety and tolerability of IM administration of increasing single doses          of NV1FGF        -  To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection site          and remote site)        -  To evaluate the presence of FGF-1 receptors in injected tissues (injection site and          remote site)        -  To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote          site), in multiple organs/tissues when appropriate, and plasma        -  To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at          remote site        -  To collect data from plasma NV1FGF pharmacokinetics        -  To evaluate healing of the amputation site   "
252117|NCT01157156|"     The primary objective is to evaluate safety and tolerability of single and repeated     administrations of escalating doses of NV1FGF administered intramuscularly in patients with     severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or     Grade III, category 5 and 6).      Secondary objectives are:        -  To determine the biological activity of NV1FGF on collateral artery development.        -  To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.   "
252119|NCT01157182|"     The objective of this study was to determine and compare the rate and extent of absorption of     norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone     Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg     norethindrone acetate) Tablets under fasting conditions.   "
252120|NCT01157195|"     Constraint-Induced Movement therapy, also known as CI therapy, is an approach to physical     rehabilitation derived from basic behavioral and neuroscience research. It has been shown to     be efficacious for rehabilitating use of the more-affected arm in individuals more than one     year after stroke with mild to moderate motor impairment. The first component of the therapy     is intensive training in use of the more-affected arm on functional tasks for 3 hours daily     for 10 consecutive weekdays. The second is wearing a protective safety mitt on the     less-affected hand for all waking hours of the approximately 2-week treatment period that it     is safe to do so. The purpose of the mitt is to discourage use of the less-affected arm. The     third is a group of behavioral techniques designed to transfer gains from the treatment     setting to the real world, which takes a therapist, on average, 30 minutes to implement on     each treatment day.      The purpose of this project is to develop and test a method for automating the delivery of     this efficacious treatment in a way that the therapy can be provided in stroke patients'     homes. After developing an automated CI therapy workstation that has tele-health     capabilities, the investigators will conduct a randomized controlled trial to evaluate     whether CI therapy delivered in the home using this workstation with remote supervision by a     therapist via an Internet-based audiovisual link provides outcomes that are just as good as     CI therapy delivered by a live therapist.   "
252121|NCT01157208|"     The purpose of this study is: 1) To assess the feasibility of implementing a clinical trial     comparing two potentially analgesic dietary interventions in patients with chronic daily     headache (CDH) and 2)To assess the preliminary efficacy of the dietary interventions on     headache frequency and severity and 3) to assess the impact of the diet on the percentage of     omega-6 highly unsaturated fatty acids (HUFA) in total HUFA in whole blood.      During a 6-week baseline phase, eligible individuals with CDH will complete web-based daily     diaries, self-report questionnaires, and nutrient intake assessments. Before randomization to     one of the two intervention groups, blood will be collected to measure baseline nutritional     biomarkers. Targeted dietary advice will be administered and foods will be provided     throughout the 12-week intervention phase. Samples for biomarkers will be collected every 4     weeks during the intervention. Participants will continue recording headache characteristics     with a daily headache diary. At the conclusion of the intervention, participants will provide     complete follow-up assessments and blood for nutritional biomarker measurement.   "
252153|NCT01150357|"     This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering     effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid     and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid     dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600     mg of aliskiren. This study is being conducted to support monotherapy registration of     aliskiren for the treatment of hypertension in children 6-17 years of age.   "
252122|NCT01157221|"     Background: Few studies have examined the predictors of the clinical course of subjects with     frozen shoulder syndrome or explained the persistence of symptoms after appropriate therapy.     Altered shoulder kinematics may predispose subjects to subacromial impingement, rotator cuff     tendonitis, altered shoulder joint forces, and possible degenerative changes. Subsequently, a     more difficult and chronic course of frozen shoulder syndrome may develop.      Objective: The purposes of this study are: (1) to develop a prediction method for determining     altered shoulder kinematics and associated muscular activities which are associated with the     chronicity of frozen shoulder dysfunction, and (2) to validate this prediction method and     analyze the impact of the method on clinical behavior.      Design: For the first year, a prospective study will be conducted to develop a prediction     method that will identify impaired shoulder kinematics associated with the degree of     symptom-related functional disability in patients with frozen shoulder syndrome. For the     second and third years, validation of the proposed prediction method will determine whether     altered shoulder kinematics and associated muscular activities subject to intervention meet     the prediction criteria and demonstrate improvement in their follow-up, which will be shown     to improve decision making in clinical practice.   "
252123|NCT01149954|"     The purpose of this study is to compare the rate and extent of absorption of ibuprofen 200 mg     gelcaps (test) versus Advil liquigels (reference) administered as 1 x 200 mg gelcap under fed     conditions.   "
252124|NCT01149967|"     This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's     Laboratories Limited under fasting conditions.   "
252125|NCT01149980|"     This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's     Laboratories Limited under fed conditions.   "
252126|NCT01149993|"     Patients undergoing living donor renal transplant will be asked to participate to determine     whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving     an additional dose of antibody induction therapy helps to alleviate potential damage to the     transplanted organ post-transplant. A number of lab tests will be done post-transplant to     determine how well the kidney is functioning.   "
252127|NCT01150006|"     The inflammatory state and composition of atherosclerotic plaques are considered the main     contributing factors responsible for acute cardiovascular events, rather than the degree of     stenosis. Recently, positron emission tomography (PET) with 18F-fluoro-deoxyglucose (FDG) has     been suggested as a promising novel imaging technique to identify the inflammatory state of     atherosclerotic plaque. Recently, a few clinical studies showed that circulating A-FABP level     had a close relation with the development of atherosclerosis in human. Therefore, in the     present study, the investigators examined the relationship between circulating A-FABP and     vascular inflammation of carotid arteries measured using FDG-PET in healthy male subjects.   "
252128|NCT01150019|"     Vascular inflammation is a key factor in both the pathogenesis and outcome of     atherosclerosis.Resistin was shown to induce vascular endothelial dysfunction and vascular     smooth muscle cell proliferation.      18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for     identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore,     the purpose of the study is to demonstrate the correlation between circulating resistin and     vascular inflammation detected by 18FDG-PET in obese persons.   "
252129|NCT01150032|"     QUALYOR is a prospective study on the predictive value for fragility fracture of various new     techniques assessing bone quality, among postmenopausal women with low bone mass.   "
252518|NCT01161316|"     The purpose of the study is to evaluate the efficacy and safety of the combination of     mFOLFOX-6 plus cetuximab for 8 cycles followed by mFOLFOX-6 plus cetuximab or single agent     (s/a) cetuximab as maintenance therapy in patients (pts) with metastatic colorectal cancer     (mCRC).   "
252130|NCT01150045|"     PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium,     and fluorouracil together to compare how well they work when given together with or without     celecoxib in treating patients with stage III colon cancer previously treated with surgery.      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. It is not yet known whether giving     oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib     in treating colon cancer.   "
252131|NCT01150058|"     RATIONALE: Studying cell samples from patients with cancer in the laboratory may help doctors     learn more about changes that occur in DNA and identify biomarkers related to cancer      PURPOSE: This research study is studying drug biomarkers in cell samples from patients with     acute myeloid leukemia.   "
252132|NCT01150071|"     Background: In a national Norwegian cohort of children born before 28 weeks gestation or with     a birth weight less than 1000 g born in 1999 and 2000, 372 survived. Compared with earlier     studies survival increased for the most immature infants, but at the cost of more early     complications and a high rate of impairments, while the less immature children had fewer     early complications and less impairments detectable within 5 years. These changes show the     importance of monitoring outcome as treatment modalities change. Large brain haemorrhages     were highly predictive of severe disabilities, but we have not found good predictive factors     for milder impairments such as cognitive, behavioural and motor difficulties. However, at 5     years later function may be difficult to predict, and the children's potentials are better     understood after completing several years in school. Objectives: The children will be     re-examined at age 11 in order to assess their physical and mental health, and cognitive,     motor and social function, and to determine if early life events and development at 2 and 5     years are predictive of long term health and functioning. MRI-studies, including functional     MRI will be performed to examine if different outcomes related to brain function can be     explained by differences in brain development. Methods: For all, data will be collected from     the compulsory national test in 5th grade and questionnaires to the child, parents and     teacher. For children in Western Norway (n=87) extensive examinations of lung and brain     function, including clinical diagnostic tests and MRI, will be added. For all aspects of the     study the investigators have appropriate current and historic reference populations for     comparison. Implications: Knowledge on causes and of early predictions of outcome is needed     to give appropriate advice to families, professionals and society, and to develop preventive     programs.   "
252154|NCT01150370|"     The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the     safety and efficacy of the circumcision device for applying it to the national scale up of     adult male circumcision in Rwanda   "
252245|NCT01151592|"     The objective of this study is to assess the safety and tolerability of Venofer in patients     with chronic kidney disease who cannot tolerate Ferumoxytol (Feraheme) or intravenous iron     containing a dextran (INFed or Dexferrum).   "
252133|NCT01150084|"     Increasing rates of sedentary living, often complemented by obesity, among large segments of     the adult population are associated with costs to individual health and well-being and     thereby to society as a whole. Although some workplaces offer physical activity     opportunities, those employees who tend to need it the most (i.e., the health needy) are     often not attracted. In this project, the investigators propose to develop and evaluate a     programme that is targeted to the sedentary health needy employees. The investigators will     work with the corporate partner (a large university) to attract such employees through an     extensive social marketing driven campaign. A 16-week lunchtime walking programme is proposed     in which walking groups are offered followed by support and motivational strategies for     longer term independent walking. The investigators will examine the effects of the programme     on total amount of walking (including a follow-up assessment 4 months later) and will use     innovative technology (Smartphones) to also examine the effect of lunchtime walks on     well-being and work performance within and between participants.   "
252134|NCT01150097|"     The reason for this extension is to evaluate the long-term safety and efficacy of two     concentration-controlled everolimus regimen in de novo liver transplant recipients. The most     important long-term safety assessments include evaluation of renal function, progression of     HCV related allograft fibrosis, and other treatment related effects at Month 36     post-transplantation compared to extension baseline (Months 24 post-transplantation).   "
252135|NCT01150110|"     The purpose of this study was to compare the effectiveness of soft occlusal splint therapy on     the electromyographic activity of masticatory muscles (ateriors temporalis and masseter)     before and after the application of a muscle relaxation splint. Electromyography recordings     from the masseter and anterior temporalis muscles were analyzed quantitatively during maximal     clench, rest and mastication usual, before and after the treatment without a splint. Ten     patients whose chief complaint was Temporomandibular Disorders (TMD) were selected for the     study. After the initial evaluations soft occlusal splints (muscle relaxation splints) were     applied, and the patients were instructed to use the splints for four weeks. Surface     electromyographic recordings were taken from each patient, as clinical evaluations of TMD     (Index of Helkimo), both evaluations before the beginning of clinical therapy and after four     weeks of wearing splints. The data obtained were analyzed by Wilcoxon´s and Friedman´s tests.   "
252136|NCT01150123|"     This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.   "
252137|NCT01150136|"     Cystic fibrosis (CF) is the most common lethal, inherited disorder among Caucasians. Choline     is an essential vitamin and as a methyl donor is critically needed to support the normal     metabolism. Our previous studies have demonstrated that children with CF have depleted levels     of choline. The purpose of this study is to gather data on the status of choline and related     metabolites in children with Cystic Fibrosis by age and gender. The hypothesis for this study     is that in children with CF, deficiency of choline and related metabolites will increase with     increasing age.   "
252148|NCT01150292|"     Aim: to determine the effects of DHA supplementation:        -  on the platelet function through their aggregation and the pathway of arachidonic acid          metabolism        -  on redox status on cells and plasma        -  on inflammation in 16 type 2 diabetic patients in a cross-over study comparing DHA (400          mg/day for 2 weeks) vs Sunflower oil (placebo). Each period is separated by a wash-out          period of 6 to 9 weeks.   "
252149|NCT01150305|"     Hearing impairment is a common disorder that affects at least 7% of individuals in our     countries. Even the causes of hearing impairment are numerous, genetic causes represent the     main factor of sensorineural deafness. Among hereditary non-syndromic deafness     autosomal-dominant inheritance is observed in about 10-20% of the cases. These forms of     deafness are usually post-lingual and progressive. To date more than 41 chromosomal     localisation and 21 genes associated to non syndromic dominant deafness have been described.     It represents an extreme genetic heterogeneity making difficult the studies of these forms of     hearing impairment. But, genetic diagnostic testing is crucial in these cases. Indeed,     therapeutic research are in the way to prevent the progression of the disorder. The aim of     this work is to establish the prevalence of the different genes involved in these forms of     deafness.   "
252138|NCT01150149|"     Most countries of the world, including the USA are making preparations for a possible     influenza pandemic. Such an event will constitute a global public health emergency, but it is     impossible to predict when this will happen. Up to 80 million people could die worldwide, so     as much as possible needs to be done in advance to find ways of how the impact can be     reduced. Although the investigators know that medical interventions such as anti-influenza     drugs and antibiotics will be important, even in well resourced countries these might be in     short supply. Vaccines will also be important but these will not be available until at least     4-5 months after the pandemic has started. This means that other non-pharmaceutical measures     could well be important such as social distancing, school closures and the use of face masks.     Guidance also needs to be developed so that families can care for each other whilst     minimizing the spread of infection. To do these things, the investigators need to know how     influenza is transmitted from person-to person. This is poorly understood at present. The     investigators also need to know if face masks work before recommendations for public use can     be made. The best way to study influenza transmission and the effectiveness of masks is to     perform a study using healthy adult volunteers. The investigators will do this by giving some     volunteers normal influenza via nasal drops. When they get symptoms the investigators will     create an 'experimental household' by getting them to live with other non-infected volunteers     for 48 hours, in a specially designed quarantine isolation unit. Some of the non-infected     volunteers will be unprotected; others will be selected randomly to wear either face masks or     a special plastic 'cloak' so that they do not touch their faces; another group will wear     both. The investigators will then measure the rate at which the different groups get 'flu'.     From these data the investigators can work out whether it is touching the face or coughing     and sneezing that spreads flu most or whether both are important; the investigators can also     deduce how well face masks work to prevent spread. The investigators need almost 2000     volunteers for this study, it will take at least 2 years to complete and it will be very     costly, however, the results will be of global importance. If the study is successful, the     investigators can tell governments around the world whether face masks work to prevent     influenza and be clearer about the guidance that should be given to families.   "
252139|NCT01150162|"     A Prospective Randomized, Multi-center study to assess the Safety and Efficacy of Mucosta     (Rebamipide), in combination with Omeprazole as adjuvant therapy in Gastric Ulcer Patients.   "
252140|NCT01150175|"     The purpose of this study is to determine whether direct endomyocardial injection of     autologous bone marrow cells is effective for enhancement of neovascularisation in patients     with ischaemic heart failure.   "
252141|NCT01150188|"     Elevated fat level in blood is a risk factor for coronary heart disease, a major cause of     death in America. The overall goal of this project is to test a novel treatment using     nutrient (amino acid) supplementation against this condition in men and women, and to     understand how this treatment works.   "
252188|NCT01150838|"     The purpose of this study is to determine the least amount of propofol that is needed to     place a breathing tube in children 1-12 years old.   "
252142|NCT01150201|"     Study objective: To investigate the potential anti-proteinuric and renoprotective efficacy of     aliskiren in addition to losartan in patients at risk of developing end-stage renal disease     (ESRD)      Methods: This will be a randomized, double-blind study in which proteinuric, non-diabetic     patients with chronic kidney disease (CKD) will be assigned in a 1:1 ratio to one of the     following treatment groups for 3 years:        -  Group A: Losartan (Control arm: conventional treatment)*        -  Group B: Aliskiren plus Losartan (Intervention arm)*             -  With optional addition of other anti-hypertensive agents to achieve an optimal               target blood pressure of <130/80 mmHg.   "
252143|NCT01150214|"     This is a multi-center, observational, 1-year prospective cohort study (1 year follow-up, at     3, 6 and 12 month) with approximately 675 participants. We will conduct a thorough outcomes     assessment utilizing data from Magnetic Resonance Imaging (MRI) scans, as well as     pre-procedure and follow-up data. Scans will be blinded to location of participating site.     MRI scans will be sequenced and analyzed as they arrive from the database.      Imaging Protocol: All patients will undergo a Delayed-Enhancement MRI (DE-MRI) within 30 days     prior to the atrial fibrillation (AF) ablation procedure. The purpose of the initial MRI is     to quantify the degree of atrial structural remodeling or fibrosis pre-ablation. Following     ablation, DE-MRI will be obtained at 3, 6, and 12 months follow-up to detect and quantify     ablation-related scar formation.      Clinical Follow-up: The institution where the ablation was performed will continue     post-procedural care following standard of care procedures.      Atrial arrhythmia recurrences will be catalogued up to one year post-ablation and predictors     of recurrences of AF will be determined by statistical analysis. The specific mechanism and     electrophysiological characteristics of atrial arrhythmia recurrence will also be analyzed.      Our hypotheses are (1) DE-MRI will reproducibly stage the progression left atrium fibrosis in     AF; (2) DE-MRI will reproducibly aid in quantifying and identifying the distribution of     catheter ablation-related scarring in the left atrium; and (3) the stage of left atrium     fibrosis pre-ablation and the amount and location of scarring will predict success of     catheter ablation therapy for AF.   "
252144|NCT01150240|"     A Swiss national, multi-centre, online patient and research database will be created, using     the existing ESID database server system. This database contains disease-specific data from     patients with primary (inborn) immunodeficiency diseases (PID).   "
252145|NCT01150253|"     Various studies in animals and humans have shown a potential beneficial effect of probiotics     consumption on allergy. However, few studies exist that document their efficacy for upper     airways allergies such as allergic rhinitis. The objective of this study is to investigate     the effect of short-term oral administration of a Lactobacillus paracasei on a nasal     provocation test (NPT) with grass pollen, performed out of pollen season. Adult volunteers     with allergic rhinitis are enrolled in a randomized, double-blind, placebo-controlled study,     based on two 4-weeks cross-over periods of product consumption (probiotic-fermented milk     versus placebo), separated by a washout period of 6-8 weeks. Objective and subjective     clinical parameters of NPT as well as systemic and nasal immunological parameters are     compared between the two treatment periods.   "
252146|NCT01150266|"     This is a pilot study of thrombolytic therapy in patients with ischemic stroke who present     with stroke symptoms upon awakening.   "
252147|NCT01150279|"     This study will examine the feasibility, acceptability and usability of a semi-quantitative     urine pregnancy test (dBest One Step hCG Panel Test Kit) for at-home follow-up after early     medical abortion using mifepristone+misoprostol. The study seeks to:        1. Assess the feasibility of using this test in lieu of standard one-week clinic-based          follow up for determination of complete abortion status as part of normal service          delivery. In Mexico, follow up will be in two weeks, as is standard care in that .        2. To determine if women using this test at home understand how to use it and can correctly          interpret the results; is it practical.        3. Assess women's and provider's acceptability of using at-home pregnancy tests in lieu of          clinic-based follow up for confirmation of complete medical abortion in the future.   "
252303|NCT01158222|"     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth or by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating     patients with previously untreated metastatic kidney cancer.   "
252150|NCT01150318|"     Papillary cancer may affect patients of any age,with a good prognosis. Most of young patients     may hence procreate as often as the general population.131iodine is an essential tool during     treatment of thyroid cancer. According literature data, 131iodine given patients may     experience exocrine testicular dysfunction with transient azoospermia, as a significant     growing number of Desoxyribonucleic acid (DNA) damage may concern the patient or his     offspring. The primary purpose will be to study a genomic instability within the germinal     line, based on a significant mutation rate analysis in their minisatellites regions after 100     mCi 131 iodine irradiation compared to the baseline spermogram of each patient, thus being     his own control case in a cross-over study.The inclusion of 50 patients treated by surgery     prior to131iodine would result in statistically significant results.This multicentric     cross-over study with a multidisciplinary approach will act for a direct benefit on testis     function in patients aged 18-45 treated by 131iodine for thyroid cancer. Samples measurements     timing will be: after surgery, 2 and 12 months after 131iodine administration.   "
252151|NCT01150331|"     Compare the efficiency of the association, first line, the intravenous levetiracetam and the     intravenous clonazepam, in that of a monotherapy of clonazepam intravenous in the     pre-hospital treatment of tonicoclonic generalised status epilepticus.   "
252152|NCT01150344|"     Riamet® or Malarone® are both recommended as the first line treatment for uncomplicated     malaria in France, according to the French consensus Conference revised in 2007 on the     treatment of imported malaria.      The aim of the study is to compare both tolerance and efficacy of Malarone® and Riamet® in     the treatment of uncomplicated imported malaria and to determine clinical and parasitological     predictive factors associated with a less effectiveness. It's a multicentric, randomised     study in adults with uncomplicated malaria. Treatment will be administered for 3 days, and     patients will be followed for 28 days, to evaluate the therapeutic evolution. 640 patients     will be included among 15 centres.   "
253545|NCT01174160|"     This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in     a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to     sinus rhythm compared to placebo.   "
252155|NCT01150383|"     Chronic obstructive pulmonary disease (COPD) is number four of the leading causes of death in     the USA and Europe. Moreover, among the top five causes of death, this disease is the only     one with increasing mortality rates. Physical training has become an evidence based     therapeutic intervention in these patients.      In this study the investigators aim to establish if supplemental oxygen during strength and     endurance training improves exercise tolerance. Furthermore, the investigators want to     research, if supplemental oxygen has the ability to increase training intensity, which would     lead to a greater training effect with respect to respiratory, vascular, inflammatory and     anthropometric parameters, as well as quality of life.      SCOPE is a prospective, randomized, double-blinded, controlled, cross-over trial. The     investigators aim to enroll 40 patients suffering from COPD aged >30 years. Inclusion     criteria are FEV1 30-60%, and PO2 at rest >55 mmHg. At baseline, patients will undergo     pre-tests including pulmonary, exercise physiological and medical investigations. Prior to     the exercise training, an intervention-free control period with usual care is planned. This     will be followed by 2 x 6 weeks with physical training (ergometer based endurance training     and strength training, using weight lifting machines) with either supplemental oxygen or     usual room air (e.g.: first 6 weeks of exercise with oxygen supplementation followed by 6     weeks of room air). After the initial control period and between these two exercise periods,     patients will be tested as described in pre-tests, and at the end of the second exercise     training period. In addition, the investigators will assess changes in lung function and     symptomatic dyspnoea, as well as in quality of life (St. George's Respiratory Questionnaire).      Within this study, the investigators hope to improve rehabilitation programs for COPD     patients.   "
252156|NCT01150396|"     Pregnant women at risk of giving birth before 28 weeks' gestational age will be enrolled.     Fetal circulation will be studied and blood for inflammatory parameters will be collected. If     birth occurs before 28 weeks, detailed information on clinical course of the newborn until     discharge from the neonatal intensive care unit will be recorded,and specimens of amniotic     fluid, placenta, blood and urine will be collection for inflammatory parameters. After     discharge the children will be followed according to a specific protocol until 5 years of     age.   "
252157|NCT01150409|"     The proposed study will evaluate the potential benefit of a tapered course of hydrocortisone     compared to abrupt cessation in patients initiated on hydrocortisone for septic shock. The     study will include adult patients in the medical intensive care unit (MICU) who meet criteria     for corticosteroid therapy for septic shock according to the current MICU protocol.All     patients will receive 7 days of hydrocortisone (50mg/Q6hrs) as part of the routine management     of septic shock, before being randomly assigned to receive hydrocortisone taper versus no     taper. The primary study endpoint is the incidence of hypotension within 7 days after     randomization. Secondary endpoints will include incidence of adrenal insufficiency, and     changes in the inflammatory status (assessed by cytokine measurements) before, during, and     after corticosteroid discontinuation. The cytokines to be measured include IL-1, IL-6, IL-9,     IL-10, and TNF. Since there has not been a randomized clinical trial to investigate the     potential benefit of weaning septic patients off low-dose hydrocortisone as opposed to     stopping abruptly, this study has potential to change clinical practice by leading to a     consistent approach of corticosteroid discontinuation and to a better understanding of their     impact on the inflammatory modulation in septic shock.   "
252158|NCT01150422|"     This trial will compare the efficacy and acceptability of post-medical abortion follow-up by     assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy     test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine     follow-up visit including a bimanual exam and vaginal ultrasound.      The goal of the study is to provide answers to the following questions:        1. Is a follow-up protocol that employs a self-administered questionnaire and at home use          of a semi-quantitative pregnancy test effective at identifying women with ongoing          pregnancies?        2. Is an innovative follow-up protocol more acceptable to women and providers than the          current standard of care?        3. Is an innovative follow-up protocol feasible to implement in abortion services in          Vietnam?   "
252711|NCT01157702|"     The purpose of the study is to verify the immunogenicity and tolerance of a trivalent     seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the     2010/2011 season for yearly licensing application.   "
252159|NCT01150435|"     Mobility is a contributing factor in today's society. Drug dependence displays not only a     medical but also an economic problem: Especially for an intended reintegration of a drug     dependant patient in maintenance therapy the possession of a driving licence could be     decisive for a job allocation and therefore the intended reintegration to society.      Subject of this study was to verify if patients under substitution therapy with R, S-     Methadone, S- Methadone, Buprenorphine and Buprenorphine plus Naloxone are just as fit to     drive a car as a non drug dependent person.      For this investigation we compared 121 drug dependent patients in stable maintenance therapy     for a minimum of two years without consumption of any other psychotropic substances than     their maintenance drug (including THC) with non- drug dependant subjects of the same gender,     age and level of education.      This is the largest study on this topic worldwide. The neuro- cognitive working order was     tested by means of the Vienna Test System an objective, reliable and valid test quantifying     reaction time, attention efficiency, concentration, maximum resilience and orientation.     Current use of any other psychotropic substance or alcohol just as any serious illness     (including psychiatric diseases, except for an effectively treated depression) lead to     exclusion from this study.   "
252160|NCT01150448|"     The purpose of this study is to evaluate the long term safety of flexible doses (50 to 150 mg     equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to     document the pharmacokinetics of paliperidone following fixed multiple intramuscular     injections of paliperidone palmitate 150 mg eq.   "
252161|NCT01150461|"     The purpose of this study is to determine whether taking losartan helps people with     hypertrophic nonobstructive cardiomyopathy feel better by decreasing the amount of heart     muscle thickening and/or the amount of heart muscle scarring.   "
252162|NCT01150474|"     Our primary aim is to determine whether the routine use of belladonna and morphine     suppositories will improve pain control following vaginal surgery. Treatment will begin     immediately following surgery and every 8 hours for 16 hours.   "
252163|NCT01150487|"     The aim of this study is to determine the validity of two tests on bone marrow of sensitized     kidney transplant recipients in order to better understand why these patients with antibodies     against their donors are at a greater risk of rejection of their transplanted organs.   "
252164|NCT01150500|"     The objective of the study is To verify the safety and efficacy of the MDT-4107 Drug-Eluting     Coronary Stent in the treatment of de novo lesions in native coronary arteries with a     reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.   "
252165|NCT01150513|"     Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no     standard regimen. Some data showed that platins could improve the efficacy of advance TNBC.     In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better     efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).   "
252166|NCT01150526|"     The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage,     diminish inflammatory response, and improve muscle strength recovery following an acute     exercise stress. HMB in a free acid gel or in CaHMB capsule form will be administered as     either a single dose before a bout of acute exercise or in multiple doses (one before and     three daily doses for the 4 days following the acute exercise). We hypothesize that HMB in     free acid gel will result in less muscle damage, diminished inflammatory response, and     improved muscle strength recovery than either a placebo or CaHMB treatment following a bout     of acute eccentric exercise. Our endpoints will include measurements of: (1) markers for     muscle damage (CPK and LDH); (2) indicators of inflammation (CRP, TNF-α, IL-6, IL-1ra and     IL-18); and (3) muscle strength recovery and soreness.   "
252167|NCT01150539|"     The effects of a 16-week exercise training program on insulin resistance and adiposity in     overweight/obese women with Polycystic ovary syndrome (PCOS).   "
252168|NCT01150552|"     The main focus of the study is:        -  To estimate seroprevalence of AI in poultry-exposed and non-exposed human populations.        -  To estimate the incidence of AI in poultry-exposed and non-exposed human populations.        -  To investigate risk factors associated with AI infections in occupationally-exposed          poultry workers.      The secondary objectives of the study:        -  To investigate patterns in transmission of AI to household contacts of AI clinical cases        -  To isolate AI viruses from acute cases        -  To monitor the pathogenicity and disease severity of AI viruses causing human infections   "
252169|NCT01150565|"     The purpose of this study is primarily to evaluate the safety and tolerability of two dose     levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to     severe symptoms of interstitial cystitis.   "
252170|NCT01150578|"     This study is for people who have a SPECT scan (nuclear imaging of the blood flow to the     heart muscle) ordered by their medical doctors. As part of the SPECT scan, they will have     been given a drug called regadenoson to widen and expand the blood vessels bringing blood to     the heart muscle. The SPECT pictures of the heart are taken about an hour after the     regadenoson is put into an arm vein through an IV. In this study, additional echo pictures     will be taken and compared to the SPECT pictures.      The aim of the study is to see if the echo pictures work as well as SPECT to measure the     blood flow to the heart muscle.   "
252171|NCT01150591|"     Hypothesis 1: Microaspiration, as diagnosed by bronchoalveolar lavage (BAL) pepsin, is common     in patients with IPF.      Hypothesis 2a: Baseline clinical variables and co-morbid conditions are risk factors for     microaspiration in patients with IPF.      Hypothesis 2b: Baseline biological variables reflecting alveolar epithelial injury and     inflammation are markers of microaspiration in IPF.      Hypothesis 3a: Microaspiration will lead to a more rapid rate of decline in pulmonary     function.      Hypothesis 3b: Microaspiration will lead to higher rates of urgent medical care use (i.e.     unscheduled clinic visit, emergency room visit, or hospitalization).   "
252172|NCT01150604|"     The purpose of this study is to determine whether an eight-lesson self-help intervention     delivered online will result in a reduction of depressive symptoms.   "
252209|NCT01151111|"     Parkinson's disease patients may have pronounced ON-OFF motor fluctuations. These motor     fluctuations are currently treated with medication and surgery, which are limited by their     efficacy and side effects. Our study aims to determine whether relaxation guided imagery can     alleviate the OFF state of PD patients and therefore can be used as an adjunct to     conventional medication.   "
252173|NCT01150617|"     Primary objective of the study is to test whether an intensified insulin therapy     incorporating the target of normal fasting glucose (<5.5 mmol/L) and glycated hemoglobin     <6.5% is able to halve the incidence of angiographic restenosis at 6 months (expected rate     45%, to be reduced at 15%) after peripheral angioplasty compared with standard care to     achieve a glycated hemoglobin <7.0% in patients with type 2 diabetes and limb ischemia.      Secondary objectives include the identification of markers associated with, and predictive     of, restenosis and the investigation of the underlying pathophysiological background, with     specific focus on the role of nitric oxide (NO), mechanisms of endothelial     activation/apoptosis, inflammation and matrix remodeling risk profiles, candidate gene     polymorphisms and endothelial progenitor cells evaluation.      Methodology: This is a randomized, open-label, clinical trial comparing two regimens of     insulin therapy having as an outcome measure the incidence of angiographic restenosis at 6     months after peripheral angioplasty. Seventy consecutive patients with type 2 diabetes and     peripheral arterial disease undergoing peripheral angiography and subsequent angioplastic     procedure will be studied. Patients will be treated by intensive insulin therapy, based on     three pre-prandial administrations of regular insulin or short acting insulin analogues     combined with the long-acting insulin analogue glargine or standard care based on once-daily     insulin and oral antidiabetics agents. Patients randomized to the intensive insulin therapy     arm will be educated and followed up with daily measurements of fasting glucose and weekly     phone contacts with the target of fasting glucose <5.5 mmol/L (99 mg/dl) to obtain glycated     hemoglobin <6.5%. The control arm will be followed to achieve a target of glycated hemoglobin     <7.0%. Life style recommendations, including diet and physical activity program, will be the     same for the two arms. All patients will undergo three visits with physical examination and     blood sampling, at baseline and at 2, 4 and 6 months after angioplasty. Moreover, patients on     normal fasting glucose arm will be monitored by phone on weekly basis in order to test their     adherence to therapeutic target.   "
252175|NCT01150643|"     RATIONALE: Studying the effects of rituximab in blood and tumor tissue samples from patients     with cancer in the laboratory may help doctors learn more about the effects of rituximab on     cancer cells. It may also help doctors identify biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in samples from patients with follicular     lymphoma treated with rituximab.   "
252176|NCT01150656|"     RATIONALE: Studying the effects of obatoclax mesylate in cell samples from patients with     cancer in the laboratory may help doctors learn more about the effects of obatoclax mesylate     on cancer cells. It may also help doctors identify biomarkers related to cancer.      PURPOSE: This research study is studying obatoclax mesylate in samples from young patients     with acute myeloid leukemia.   "
252177|NCT01150669|"     This research study is studying lestaurtinib with or with chemotherapy in samples from young     patients with leukemia. Studying the effects of lestaurtinib with or without chemotherapy in     cell samples from patients with cancer in the laboratory may help doctors learn more about     the effects of this treatment on cancer cells. It may also help doctors identify biomarkers     related to cancer.   "
252351|NCT01158859|"     The primary issue is to determine whether preoperatively administered pregabalin decreases     the necessary dose of propofol during induction of general anesthesia. The investigators     secondary issue is to test if preoperatively administered pregabalin decreases anxiety.   "
252178|NCT01150682|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research study is studying the role of biomarkers in endometrial cancer     recurrence in samples from patients with stage II, stage III, or stage IV endometrial cancer.   "
252179|NCT01150695|"     The purpose of this study is to compare 2 experimental vaccines that could provide protection     from the disease, tularemia. This research will compare the ability of the vaccines to cause     the body to develop an immune (protective) response and obtain more information on side     effects of the vaccines. About 220 male and non-pregnant female volunteers 18 to 45 years     will participate. Volunteers will be assigned to 1 of 2 vaccine groups by chance. About half     of the volunteers will be placed in the DVC-LVS vaccine group and half of volunteers will be     placed in the USAMRIID-LVS vaccine group. Additionally, both groups will receive an injection     of placebo (inactive salt water). Study procedures include physical exam and blood and urine     samples. Evaluation of the vaccination sites will be performed as well as blood samples to     measure the body's response to the vaccine. Participants will be involved in the study for     about 6 months.   "
252180|NCT01150708|"     Background:        -  Syringomyelia is a disorder in which a cyst (syrinx) forms within the spinal cord and          causes spinal cord injury, with symptoms worsening over many years, including paralysis,          loss of sensation, and chronic pain. Researchers are interested in obtaining more          knowledge about how a syrinx forms in order to develop safer and more effective          treatments for syringomyelia and related conditions.        -  The goal of surgical treatment of syringomyelia is to eliminate the syrinx and prevent          further spinal cord injury. In most patients, surgery results in the syrinx becoming          smaller, but the effect of surgery on a patient s muscle strength, pain level, and          overall function has not been studied over time. In addition, some individuals with          syringomyelia or related conditions are not considered to be good candidates for          surgery, and more information is needed about potential alternative treatments for these          individuals.        -  By recording more than 5 years of symptoms, muscle strength, general level of          functioning, and magnetic resonance imaging (MRI) scan findings from individuals who          receive standard treatment for syringomyelia, researchers can obtain more information          about factors that influence its development, progression, and relief of symptoms.      Objectives:      - To conduct a 5-year natural history study of individuals with syringomyelia and related     conditions.      Eligibility:      - Individuals at least 18 years of age who have syringomyelia or related conditions     (including pre-syringomyelia or Chiari I malformation without syringomyelia).      Design:        -  This study requires 7 outpatient visits to the National Institutes of Health Clinical          Center: an initial visit; a visit 3 months later; and visits 1, 2, 3, 4, and 5 years          after the initial visit. An additional 10 days of inpatient treatment and testing will          be required if surgery is needed during the study.        -  The following tests will be performed during this study:        -  Medical history and physical examination, which may also determine eligibility for          surgery        -  Detailed neurological history and examination        -  Blood and urine samples        -  MRI scans: Participants will have 2 scans at the initial evaluation, 2 scans at the          3-month visit, and 1 scan every year for the following 5 years.        -  Additional neurological and imaging tests if needed, including a lumbar puncture to          collect spinal fluid, a myelogram (imaging study) of the spinal fluid, and a computed          tomography scan of the skull and spine.        -  Participants who are surgical candidates will have additional tests along with the          surgery, including diagnostic studies (electrocardiogram and chest X-ray) before surgery          and an MRI scan 1 week after surgery.   "
252210|NCT01151124|"     The study is designed to test the safety of a manufactured neural stem cell line (CTX cells)     delivered by injection into the damaged brains of male patients 60 years of age or over who     remain moderately to severely disabled 6 months to 5 years following an ischemic stroke. In     addition the trial will evaluate a range of potential efficacy measures for future trials.     Treatment will involve a single injection of one of four doses of CTX cells into the     patient's brain in a carefully controlled neurosurgical operation performed under general     anesthetic. The trial is designed to treat 12 patients and measure outcomes over 24 months.     Patients will be invited to participate in a long-term follow-up trial for a further 8 years.   "
252181|NCT01150721|"     Background:      - Pulmonary nontuberculous mycobacterial infection is a respiratory infection that is     sometimes difficult to diagnose. Proper diagnosis depends on accurate collection of     respiratory secretions, but these secretions may be contaminated by bacteria present in the     mouth at the time of collection. In addition, some individuals may have difficulty providing     respiratory secretions, because the infection affects lung function and sputum production. By     collecting new samples from individuals who have already been diagnosed with this infection,     and comparing the methods of collection, researchers hope to better understand and improve     the ability to accurately diagnose and treat the infection at an early stage.      Objectives:      - To compare throat cultures and coughed-up and induced phlegm or sputum in individuals with     pulmonary nontuberculous mycobacterial infection and inflammation.      Eligibility:      - Individuals between 18 and 79 years of age who have been diagnosed with pulmonary     nontuberculous mycobacterial infection and are currently participating in selected NIH     protocols on this infection.      Design:        -  The study will require a single 90-minute visit to provide research specimens.        -  Participants must not eat or drink for 2 hours prior to the collection of the early          morning respiratory specimens. Blood pressure, temperature, pulse, breathing rate, and          oxygen saturation level readings will be taken on the day of collection to ensure that          participants may safely provide the specimens.        -  Participants will provide the following samples:        -  Blood sample: Participants will provide a blood sample to measure indicators of          inflammation in the blood.        -  Throat swab: Participants will brush their teeth thoroughly before allowing researchers          to swab the inside of their throat with a sterile swab.        -  Sputum collection (regular and induced): Participants will brush their teeth thoroughly          and then provide both a regular sputum sample (produced normally) and an induced sputum          sample (produced after using a nebulizer to stimulate sputum production).        -  No treatment will be provided as part of this protocol.   "
252182|NCT01150734|"     Muscle evoked potentials (MEP) are supposed to different in schizophrenic and depressed     patients, compared to a sample of healthy volunteers. Transcranial Magnetic Stimulation     (TMS)-evoked MEP are measured in all three groups at baseline and after tDCS (2 mA, 20     minutes). MEP amplitudes are supposed to normalize quickly in healthy volunteers, to stay     diminished in depressed patients and to stay elevated in schizophrenic patients. These     differences should disappear after regular pharmacological treatment. Outcome measures will     be done in week 2 and week 4.   "
252183|NCT01150747|"     The primary objective is to prospectively follow 200 women with or at risk of cervicitis to     determine the chlamydia-specific cellular responses that correlate with protection against     incident infection. The hypothesis is that a positive IFN-y response by peripheral CD4+ T     cells responding to stimulation with HSP60 will be significantly associated with protection     from incident C. trachomatis infection.   "
252184|NCT01150760|"     Alvimopan is the first and currently the only FDA-approved therapy for acceleration of the     time to upper and lower gastrointestinal (GI) recovery following partial large or small bowel     resection surgery with primary anastomosis.      The primary objective of this retrospective observational trial is to assess postoperative     morbidity and mortality as reported during the index hospitalization for bowel resection and     15/30-day readmissions of alvimopan vs. non-alvimopan matched patients in the combined     Premier/Care Science database(a large medical claims database).   "
252185|NCT01150786|"     The aim of this study is to determine the effect of selenium supplementation as an     antioxidant on serum adiponectin, HSCRP , ferritin , transferrin, albumin and homocysteine     level.   "
252186|NCT01150812|"     The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the     pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after     escalating single oral low doses.   "
252187|NCT01150825|"     The primary objective of this study is to characterize the morphological patterns of high     frequency QRS components (HFQRS) in patients with acute myocardial infarction (AMI),     including STEMI and NSTEMI, compared to patients without AMI.   "
252189|NCT01150851|"     The central aim of this study is to improve understanding of how metabolic pathways that     contribute to adiposity also amplify risks of kidney disease progression and cardiovascular     disease in subjects with moderate to severe CKD. In order to achieve this goal, we propose     the following aims through a randomized 2x2 factorial design trial in subjects with moderate     to severe CKD: (a) To assess the feasibility of implementing aerobic exercise and caloric     restriction interventions, and (b) To examine the effects of aerobic exercise and caloric     restriction on a metabolic risk profile, including systemic measures of oxidative stress,     inflammation, insulin resistance, and endothelial dysfunction.      Hypothesis: We hypothesize that implementation of caloric restriction and aerobic exercise is     feasible and can improve the metabolic milieu (as assessed by measures of oxidative stress,     inflammation, insulin resistance, and endothelial dysfunction) in subjects with moderate to     severe CKD.      Interim analysis may be performed (no specific plan at this time).   "
252190|NCT01150864|"     The main hypothesis are:        1. Passive and Active-Passive airway conditioning devices reduce the incidence of          ventilator associated pneumonia        2. Active-Passive airway conditioning devices reduce the incidence of endotracheal tube          obstruction        3. Nurses' workload is reduced with Passive and Active-Passive airway conditioning devices   "
252191|NCT01150877|"     The purpose of this study is to investigate the therapeutic effect and the safety of     high-dose vitamin D supplementation in metastatic colorectal cancer patients. We propose to     supplement metastatic (stage 4) colorectal cancer patients with oral doses of vitamin D to     raise serum 25-hydroxy-vitamin D [25(OH)D] levels to the high normal range of 200-250 nmol/L.     The primary objective of this study is to evaluate the metabolic consequences, including     tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with     colorectal cancer. The secondary objective is to evaluate patient survival with regards to     high-dose vitamin D supplementation.      Hypothesis:      Whereas low doses of vitamin D reportedly play a significant role in prevention of colorectal     cancers, do much larger (pharmacological) doses of vitamin D have a significant therapeutic     effect against the same kind of cancer?   "
252192|NCT01150890|"     The study will examine the safety and effectiveness of AMG 827 for the treatment of moderate     to severe Crohn's disease. Patients will randomly receive either AMG 827 or placebo (a     lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient     will know what treatment is being given.   "
252193|NCT01150903|"     Erectile dysfunction (ED) has been identified as an independent risk factor for existing     cardiovascular disease, preceding a major cardiovascular event by an average of about 5     years. Are men prescribed a PDE5 inhibitor for ED more likely to have a new diagnosis of     underlying medical conditions compared to men of a similar age not receiving PDE5 inhibitor     treatment?   "
252669|NCT01163279|"     Healthy older adults with self-reported cognitive difficulties who receive strategy training     will demonstrate greater performance benefits on measures of real-world activities, relative     to those receiving a control intervention, immediately post treatment and at follow-up.   "
252194|NCT01150916|"     The serum albumin ascites gradient (SAAG) is a recommended tool for ascites diagnosis since     values ≥1.1 g/dl are found in nearly 97% of patients with portal hypertension. However, it     mislabels chronic liver disease and heart failure as the cause of ascites. Because type-B     Natriuretic Peptide (BNP) is increased in several body fluids of patients with both systolic     and diastolic dysfunction, it was found to be a useful marker for diagnosing heart failure     and pleural effusion due to heart failure. Nevertheless, to date, the performance of BNP     testing for assessing the etiology of ascites has not been examined. The current prospective     study is aimed at comparing the following strategies for diagnosing heart failure as the     cause of ascites: 1) SAAG plus total protein concentration in ascitic fluid (gold standard);     2) SAAG plus BNP concentration in ascitic fluid; 3) SAAG plus BNP concentration in serum; 4)     serum BNP concentrations.      SAAG, ascitic fluid protein concentration, serum and ascites type-B Natriuretic Peptide and     echocardiography will be performed in all patients. The final diagnosis of the cause of     ascites will be adjudicated by independent physicians, blinded for the results of ascitic     fluid biochemistry and BNP. Patients will be divided into four groups: Heart failure, Liver     cirrhosis, concurrent heart failure and liver cirrhosis (mixed) and other causes of ascites.   "
252195|NCT01150929|"     The purpose of this study is to determine whether patient rehabilitation is equal for     patients operated with two different knee implant designs.      The patients are randomized to treatment with either a simple hinge design implant (fixed     bearing) or an implant with a mobile bearing polyethylene. This design difference might in     principle enable the patients in the latter group to rehabilitate towards a more normal gait     pattern.   "
252196|NCT01150942|"     To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in     Korean healthy children aged 12~23 months   "
252197|NCT01150955|"     We want to investigate whether the food supplement resveratrol is able to counteract the     detrimental effects of obesity.   "
252198|NCT01150968|"     The purpose of this study is to investigate whether the addition of teaching on communication     at the end of life to the pre-existing resident curriculum will positively impact residents'     knowledge and attitudes regarding communication at the end of life.   "
252199|NCT01150981|"     Insulin resistance is a common condition that can lead to type 2 diabetes. One of the     commonly prescribed diabetes medications, called rosiglitazone, works by decreasing insulin     resistance. Rosiglitazone appears to work on fat cells. Animal studies suggest that     rosiglitazone may work by increasing blood vessel growth in fat cells. The purpose of this     research is to see if rosiglitazone also increases blood vessel growth in human fat cells.     The investigators will compare results from before and after being on rosiglitazone for 6     weeks.   "
252217|NCT01151215|"     The main purpose of this study is to compare progression free survival in patients treated     with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary     objective is to investigate the safety and tolerability of AZD8931 given in combination with     anastrozole.   "
252229|NCT01151384|"     Liposome Encapsulated Docetaxel (LE-DT) is a novel proprietary delivery system of docetaxel     developed by NeoPharm, Inc. In this Phase I study, the LE-DT was evaluated for the maximum     tolerated dose and dose limiting toxicity (DLT) in patients with advance solid tumors. It was     also evaluated for pharmacokinetic and anti-tumor effects.   "
252200|NCT01150994|"     The NIMH s RFA-Suicide Prevention in Emergency Medicine Departments recognizes the emergency     department (ED) as an important setting to increase suicide detection and prevention efforts     but observes that evidence-based practice guidelines do not exist. In response, we have     designed the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) trial.     The ED-SAFE study will be conducted using a quasi-experimental design appropriate for     studying systems-based change. The study consists of two components (Screening Outcome &     Intervention Evaluation) and three phases of data collection: Treatment as Usual, Screening     Alone, and Intervention. During each phase, 480 suicidal patients (1,440 total) will be     enrolled and followed using multiple methods for 12 months.      The Screening Outcome Component      The Screening Outcome component will use data collected during the Treatment as Usual and     Screening Alone phases. Consistent with systems-change principles, when universal screening     is incorporated during the Screening Alone phase, it will be completed by the primary nurse     as part of routine care. Primarily, it will focus on testing a practical approach to screen     ED patients for suicidal ideation and behavior and will assess its impact on suicide     detection, process outcomes, and suicide behaviors.      Intervention Evaluation Component      The Intervention Evaluation component will use data from the Treatment as Usual, Screening     Alone, and Intervention Phases. During the Intervention phase, each ED will implement a     multi-component, systems-based Intervention called the Safety Assessment and Follow-up     Telephone Intervention (SAFTI). The SAFTI will combine elements of: (a) safety planning     administered by nursing staff in the ED, and (b) Coping Long Term with Active Suicide Program     (CLASP)-ED, a series of up to 7 semi-structured telephone advising calls to the patient and 4     to the significant other over the 12 months after the ED visit. Safety planning will be     implemented universally to all suicidal patients, regardless of whether they are ultimately     enrolled into the trial, as part of a comprehensive suicide management protocol (e.g., it is     a systems-based change). However, for practical and budgetary considerations, the CLASP-ED     telephone advising calls will be administered only to participants enrolled into the study.      Our overarching hypotheses will be tested using a combination of the Screening Outcome     component and the Intervention Evaluation Component. We predict that screening will improve     detection of suicidal ideation, and the intervention will enhance the quality of care and     reduce suicide outcomes.   "
252201|NCT01151007|"     -  There is no data at present concerning the KRAS mutation in patients from Martinique          with colorectal cancer. Despite the fact that the incidence of this disease continues to          increase there is no recent data to confirm it. This study has a descriptive purpose,          allowing a comparison of the population from Martinique to other populations.        -  A study of incidence of colorectal cancer, overseen by the Association from Martinique          for the Epidemiological Search on Cancer (AMREC), also leads to a better knowledge of          the local characteristics of the colorectal cancer.        -  These two descriptive characteristics of colorectal cancer in Martinique will be useful          data for the health professionals to provide their patients better care.   "
252202|NCT01151020|"     The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US     FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular     Graft indicated for the treatment of patients with aneurysms/ulcers of the descending     thoracic aorta having vessel structure suitable for repair.   "
252203|NCT01151033|"     The objective of this study is the assessment of the performance, safety and efficacy of the     ProNOVA XR Polymer Free Drug Eluting Stent System in the treatment of patients with de novo     native coronary artery lesions.   "
252204|NCT01151046|"     To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer     patients is more effective than Exemestane alone   "
252205|NCT01151059|"     The present study will evaluate the safety and immunogenicity in healthy people (non-elderly     adult and elderly subjects) after one intramuscular (IM) dose of trivalent subunit     inactivated flu vaccine.   "
252206|NCT01151072|"     This trial was conducted in Europe. The aim of this clinical trial was to compare the     exposure and effect of NN1250 (insulin degludec) after different routes of injection in     healthy subjects.   "
252207|NCT01151085|"     To collect the efficacy and safety informations of voriconazole related to their appropriate     use in daily practice.   "
252208|NCT01151098|"     The objective of this study was to evaluate the long-term safety and tolerability of 7-day     BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain     syndromes whose pain had been previously controlled by oral opioid combination therapy.   "
252712|NCT01157715|"     This study is designed to access the safety and efficacy of multiple injections of KH902 at     variable dosing regimens in patients with CNV due to neovascular AMD.   "
252211|NCT01151137|"     Primary Objective:        -  Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events          (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or          unplanned cardiovascular hospitalization or death from any cause in patients with          permanent Atrial Fibrillation [AF] and additional risk factors      Secondary Objective:        -  Demonstrate the efficacy of Dronedarone in preventing cardiovascular death      This was an event-driven study where a common study end date [CSED] was to be determined by     Steering Committee based on the number of events (stroke, systemic arterial embolism,     myocardial infarction or cardiovascular death).   "
252212|NCT01151150|"     The current study is set up to chart clinically and laboratory findings in Norwegian patients     with symptoms attributed by themselves or their doctor to ongoing chronic Bb infection.     Objectives is to assess laboratory findings in relation to established diagnostic criteria     and to form a picture of the burden of symptoms and illness perception in this group of     patients. The study is essentially exploratory, and is supposed to raise rather than to test     hypotheses.   "
252213|NCT01151163|"     Fibromyalgia syndrome (FMS) is characterized by the presence of widespread pain, chronic     fatigue and typical sleep disturbances. The purpose of the current study is to investigate     the nature of sleep disturbance in FMS, using a novel technology. Peripheral arterial     tonometry is a method by which peripheral arterial tone is measured non - invasively using in     an ambulatory setup during sleep. The information collected reflects autonomic nervous system     function and respiratory changes during sleep. We intend to utilize this technique in order     to improve our understanding of the interrupted patterns of sleep in FMS and as a possible     biomarker which may be used in the future to follow up FMS patients and their response to     treatment.   "
252214|NCT01151176|"     The study aims to demonstrate that a simple intravenous insulin algorithm can be implemented     in Latin America and will result in safe and better glucose control in patients with Acute     Coronary Syndrome (ACS) compared with SC insulin.   "
252215|NCT01151189|"     This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to     evaluate the protective efficacy against TB disease, safety, and immunogenicity of     MVA85A/AERAS-485 in healthy, HIV-infected adults.      This study consists of 650 adults subjects (ages 18-50 years of age inclusive) who will     receive study vaccine or placebo at Study Day 0 and again 6-9 months later. Samples for     real-time evaluation of immunogenicity were to be collected from 70 subjects (immunogenicity     analysis set).   "
252216|NCT01151202|"     The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to     evaluate the safety and efficacy in patients with acute upper respiratory tract infection and     chronic inflammatory bronchitis.   "
252218|NCT01151228|"     Patients undergoing gastroscopy will undergo two pre-procedure ultrasound scans of the     stomach, once on arrival in the unit and on an empty stomach and a second time after     consumption of a randomized amount of apple juice (0, 50, 100, 200, 300 or 400 mL).     Immediately after ingestion and the second ultrasound scan, subjects will have their     gastroscopy which will start by suctioning out the apple juice. Measurements of stomach fluid     volume conducted by ultrasound will be compared to the actual volume removed during the     gastroscopy procedure.   "
252219|NCT01151241|"     Patients undergoing elbow arthroscopy surgery will receive standard anesthesia and analgesia     (infraclavicular nerve block combined with general anesthesia for surgery; continuous     infusion via infraclavicular catheter to day 3 post op). Patients in the experimental group     will be discharged home after one day, with infraclavicular catheter in place; patients in     the comparator group will stay in hospital for 3 or 4 days, per standard practice. The study     will compare range of motion as the primary endpoint, in a non-inferiority design, to see if     early discharge is feasible while providing similar recovery.   "
252220|NCT01151254|"     All patients undergoing cardiac surgery require intraoperative anesthesia and short-term     postoperative sedation with anesthetic agents after the procedure when patient is in the     intensive care unit (ICU). The clinical data obtained so far are concentrating on     intraoperative use volatile agents (preconditioning) resulting in better postoperative     cardiac function and less release of biochemical markers of myocardial damage. There are no     studies investigating whether postoperative use of volatile agents (post conditioning) in     cardiac surgical population is improving outcomes. The aim of the present study is to compare     total intravenous anesthesia and postoperative sedation versus total volatile anesthesia and     postoperative sedation in cardiac surgical population.   "
252221|NCT01151267|"     The rate of elimination of inhalation agent is directly proportional to the degree of     alveolar ventilation. Using Isocapnic Hyperpnoea (IH) device, it is possible to maintain     constant end-tidal CO2 with increased minute ventilation. This is achieved by passively     adding a flow of CO2 to the inspirate in proportion to increases in ventilation above the     baseline. In animal and human studies IH shortens the time of awakening from isoflurane and     sevoflurane anesthesia when manual positive pressure ventilation is applied. IH device could     be used for spontaneous hyperpnoea as well. The investigators want to compare recovery times     from sevoflurane anesthesia in patients with application of hypercapnic spontaneous     hyperpnoea (HSH) versus the standard anesthesia protocol (controls). 44 patients ill be     randomized to either HSH facilitated recovery, or conventional recovery (controls).The time     intervals from the end of anesthesia (turning off the vaporizer) until recovery milestones     will be recorded.   "
252222|NCT01151280|"     The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary     RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant     (OLT) patients.   "
252236|NCT01151475|"     We wish to study patients with liver cirrhosis during and 2 weeks after an acute episode of     liver coma (hepatic encephalopathy). By means of Positron Emission Tomography we investigate;     brain blood flow, brain ammonia uptake and brain oxygen consumption. We hypothesize that     blood flow an oxygen consumption is diminished and ammonia uptake increased during an acute     episode of hepatic encephalopathy.   "
252223|NCT01151293|"     Diabetes is one of the most common causes of death in Taiwan. With the raising prevalence of     diabetes, it became the fourth most common cause of death since 2002. Up to one-tenth of the     national health insurance expenditure was used directly in diabetic care. Besides, more     expenditure was used in the management of the complications of diabetes, like vascular     diseases, renal disease, blindness and neuropathy. Diabetes is a chronic disease, the target     treatment is to control HbA1c below 7%, by intensive life style modification, diet control,     exercise and medications. Diabetic patient should have a good medical compliance, in order to     prevent the tragedy of the complication. A good medical compliance is depended on the     individual personality. Personality is the major cause of chronic stress, which is one of the     most important cause of psychological stress and the risk factors of the vascular disease and     hypertension. Recently, Type D personality had shown the close relationship with patients'     prognosis, morbidity, mortality and life quality in different vascular diseases. These     vascular diseases are the result of the atherosclerotic process, and diabetes is one of the     most important risk factors of the atherosclerotic changes. The investigators believed that     type D personality may also affect the medical compliance, the severity (in terms of HbA1c),     and the prognosis of diabetic patients. The first part of this study is a cross sectional     study, the investigators will try to figure out the relationship of the type D personality     toward diabetic medical compliance, and their comorbidity. The second part of this study is a     cohort study, base on the population in first part of the study, the investigators will like     to construct the correlation of type D personality and diabetic patients' 5-years     complication and mortality. The investigators want to establish a more complete vascular care     system, improve the medical compliance, lower the complication rates, and improved the     quality of life.   "
252224|NCT01151306|"     Chronic obstructive pulmonary disease (COPD) is a condition of the lungs which results in     breathing difficulties due to the lungs becoming inflamed and the airways narrowed. Current     treatments have focused on opening up the narrowed airways but, in addition, we know there is     increased inflammation in the blood and these patients are at increased risk of heart     disease. Statins, simvastatin being one of them, are drugs used to lower cholesterol in the     blood but may also reduce inflammation and lower the risk of heart disease. This study will     explore whether simvastatin reduces one of the risk factors in patients with COPD in a short     term proof of principle study. The key purpose is to determine whether simvastatin improves     the pressure and stiffness of the main blood vessels namely the arterial stiffness measure of     aortic pulse wave velocity (PWV). In parallel, we will describe changes in airways and / or     blood inflammation and change in breathing ability   "
252225|NCT01151319|"     This is a randomised, placebo-controlled, single-blind study designed to evaluate the safety     and immunogenicity of three novel HIV vaccines.   "
252226|NCT01151345|"     This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg     Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by     Amstrong Laboratorios De Mexico, S.A. DE C.V.   "
252227|NCT01151358|"     MERIT-NHL as an addendum to the International Registry of Radioimmunotherapy (RIT registry)     pooling clinical data of patients who suffered from a non-Hodgkin´s lymphoma also includes     the documentation of the respective FDG-PET and CT-image files in an online archive.      Based on these documented clinical and imaging data, the MERIT study group centrally performs     an intra- as well as interindividual evaluation of follicular CD20+ lymphoma lesions before     and after radioimmunotherapy. According to this, the aim of the MERIT-NHL study is to     prospectively identify yet unknown patient- and lesion specific prognostic factors predicting     patient´s outcome in line with the therapeutic modality radioimmunotherapy.   "
252228|NCT01151371|"     The objective of the study is to compare the clinical performance of silicone hydrogel daily     disposable contact lenses, conventional hydrogel daily disposable contact lenses and silicone     hydrogel monthly replacement contact lenses.   "
252230|NCT01151397|"     Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy     obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3.     Studies rarely address the issues of improving host factors. The current study examines        1. Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and          shorten treatment duration (from 24 weeks to 12 weeks)        2. whether Vitamin D levels predicts negative treatment outcome.   "
252231|NCT01151410|"     The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term     safety, tolerability and efficacy profile of aliskiren compared to the active comparator     enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age,     gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive     either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be     administered once daily and children will receive study medication in a double-blind manner.     This study is being conducted to support monotherapy registration of aliskiren for the     treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study     CSPP100A2365).   "
252232|NCT01151423|"     The purpose of this study is to determine whether anti-von Willebrand factor Nanobody is safe     and effective as adjunctive treatment in patients with acquired thrombotic thrombocytopenic     purpura (TTP). Patients will receive either placebo or anti-von Willebrand factor Nanobody as     adjunctive therapy to plasma exchange.   "
252233|NCT01151436|"     The aim of this study is to assess performance and tolerance as well as investigator and     subject satisfaction linked to the global management of facial rejuvenation with a new range     of hyaluronic acid dermal fillers.   "
252234|NCT01151449|"     This phase II clinical trial studies how well gamma-secretase/Notch signalling pathway     inhibitor RO4929097 works in treating patients with advanced, metastatic, or recurrent triple     negative invasive breast cancer. Gamma-secretase/Notch signalling pathway inhibitor RO4929097     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
252235|NCT01151462|"     The aim of this study is to investigate short and long term consequences from early postnatal     HCMV infection transmitted via human milk in very preterm infants (birth weight < 1500 g or     gestational age < 32 weeks). These infants are at high risk of early death or survival with     chronic disease and neurodevelopmental impairment if infected with HCMV. Infection is a     common complication in this group of patients and reported to be the most frequent cause of     death after the second week of life. Systemic infection in the newborn period is reported as     representing an independent risk factor for survival with neurodevelopmental impairment among     very preterm infants.   "
252237|NCT01151488|"     The purpose of the study is to examine the effects of resistance training on the reasons     (mechanisms) underlying the development of fatigue, muscle weakness and wasting (sarcopenia),     and impaired physical functioning (poor balance and walking) associated with breast cancer     survivorship.   "
252238|NCT01151501|"     Acute hypoxaemic respiratory failure (AHRF) refers to pathological states in which arterial     blood oxygenation is severely impaired，and which need invasive positive pressure ventilation     (IPPV) as respiratory support technique in most cases.However，IPPV carries well-known risks     of complications such as ventilator induced lung injury (VILI) or ventilator associated     pneumonia (VAP)，and the incidence of which is increased as the prolongation of IPPV so as to     lead to higher mortality rate. Consequently，early extubation is extraordinarily necessary.      More recently, NPPV has shown to shorten the duration of IPPV，reduce the mortality and     morbidity rates in patients with chronic obstructive pulmonary disease (COPD). Despite this     evidence, the efficacy of NPPV in patients with AHRF has not been evidenced. However，NPPV has     been shown to provide adequate ventilation and oxygenation，and reduce inspiratory muscle     effort，neuromuscular drive，and dyspnea scores. Moreover，to some patints，NPPV is similar with     IPPV in providing oxygenation.      The duration of weaning is from the first day a patient met standard criteria for weaning     readiness to the time of successful extubation (lasting at least 48 h)，which represents     40-50% of the total duration of IPPV.As a result，duration of IPPV would be shortened if that     of weaning was shortened.      The investigators hypothesized that in mechanical ventilated patients with AHRF who met     standard criteria for weaning readiness and suffer failure of spontaneous breathing trial,     use of NPPV for early extubation, providing adequate ventilation and oxygenation, would     shorten the duration of IPPV as the primary end-point variable, thereby reduce the incidence     of complication and mortality rates. Accordingly, the investigators conducted a     prospective，randomized clinical trial to assess the efficacy of this strategy compared with     the conventional-weaning approach.   "
252239|NCT01151514|"     Few studies analyzed the referral time to nephrologists and its impact on the patient outcome     in a large cohort. The investigators described the incidence and determined the outcome with     respect to renal function recovery, renal replacement therapy (RRT) requirement and     in-hospital mortality of Hospital Acquired Acute Kidney Injury (HA-AKI) without nephrology     referral (nrHA-AKI) and late referred HA-AKI patients to nephrologists (lrHA-AKI) compared     with early referral patients (erHA-AKI). The patients included were admitted to the tertiary     care academic center of Lausanne (Switzerland) between 2004 and 2008, in the medical and     surgical services and in the intensive care unit (ICU).   "
252240|NCT01151527|"     We hypothesize that a peripheral blood biomarker or biological signature (gene or protein     expression pattern) of idiopathic interstitial pneumonias (IIPs) will simplify and improve     the accuracy of diagnosis of IIP and diagnose individuals at an earlier, more treatable,     stage of their disease.   "
252241|NCT01151540|"     To investigate the safety of long term administration of E2080 in the patients with     Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.   "
252242|NCT01151553|"     This is a research study that is evaluating blood markers which may predict which patients     who receive CRT will improve. Congestive heart failure (CHF) is associated with increased     oxidative stress, a condition where abnormal oxygen forms are produced. These forms harm the     cells of the heart and cause damage to the heart muscle. We would like to see if blood levels     of these forms improve after CRT, and if they can be measured early after surgery to predict     who will and who will not benefit from surgery.   "
252243|NCT01151566|"     Computed tomography (CT) scan, performed with contrast enhancement, is one of the most     commonly requested examinations in diagnostic imaging. In a patient with an elevated     creatinine or an allergy to contrast agents, the scan may be performed without the benefit of     contrast enhancement. Ultrasound (US), performed with contrast agent enhancement does not     have any nephrotoxicity and may be performed on patients with CT contrast allergy. The     investigators propose that US with Contrast enhanced ultrasound (CEUS) is superior to     unenhanced CT scan in this population.   "
252244|NCT01151579|"     The purpose of the study is to determine adverse events rates of nebulized albuterol versus     levalbuterol among adult critically ill patients and determine if a differential exists in     adverse events between the two drugs.   "
252246|NCT01157234|"     This study will investigate the blood pressure lowering efficacy of nebivolol among renal     transplant recipients who are on calcineurin inhibitors which are believed to contribute to     hypertension by sympathetic nervous system (SNS) activation and decreased prostaglandin and     nitric oxide production. Hypotheses:        1. There is a significant difference in the effect of 12 months of Nebivolol versus          Metoprolol treatment on the plasma nitric oxide level of hypertensive renal transplant          patients.        2. There is a significant difference in the effect of 12 months of Nebivolol versus          Metoprolol treatment on the estimated glomerular filtration rate of hypertensive renal          transplant patients.        3. There is a significant difference in the effect of 12 months of Nebivolol versus          Metoprolol treatment on the systolic, diastolic and mean arterial blood pressures of          hypertensive renal transplant patients.   "
252247|NCT01157247|"     Background and Objectives: Spinal puncture is painful procedure which may cause patient     refusal of spinal anesthesia in future surgery. It could be minimized with topical and     infiltration local anesthetic or intravenous opioid application before procedure. Objective     was efficacy of intravenous fentanyl in alleviating pain during spinal needle insertion.      Methods: Prospective, randomized study included 88 adults (33-55 ages, ASA I/II), scheduled     for lower leg surgery. Patients were divided in four equal study groups: spinal needle     (Quincke, 26G) with introducer (20G) was inserted alone, three minutes after local anesthetic     infiltration (2 ml of 2% lidocaine, 25Gx11/4 needle) or intravenous fentanyl application     (0.001 mg kg-1) and without local anesthetic, fentanyl and introducer. Pain was assessed     immediately after procedure by VAS score. MAP, HR and SaO2 were recorded. Sedation was     assessed by Ramsay score. Statistical analysis was performed by SPSS 11.0.   "
252248|NCT01157260|"     Indoxyl sulfate (IS) is a uremic toxin that accelerates the progression of chronic kidney     disease (CKD). AST-120 (Kremezin®; Kureha Corporation, Tokyo, Japan) removes indole, which is     the precursor of IS, in the intestine, and reduces the accumulation of IS. This drug has been     shown to retard the deterioration of renal function in CKD patients through reducing the     levels of IS.      IS was reported to promote aortic calcification and stimulate the proliferation of vascular     smooth muscle cells (VSMC). IS also inhibits endothelial proliferation and wound repair. With     this background, the investigators will performed the study whether AST-120 improve the     endothelial dysfunction in CKD patients.   "
252295|NCT01158118|"     This study will gather information about the combination the drugs plerixafor with     sargramostim in donors of blood-forming cells (stem cells). These stem cells will be     collected from the donor and transplanted into their sibling. The investigators believe that     the two drugs together will provide enough stem cells for transplantation and may also reduce     the risk of graft versus host disease.   "
252249|NCT01157273|"     Objective: To assess whether the anxiety caused by a task considered anxiogenic, Simulated     Public Speaking (SPS) test, would change the responses of healthy individuals regarding     physiological and vocal parameters. Method: The sample comprised 30 participants of both     genders, 19-42 years old, with no history of psychiatric disorders. The score in the     STAI-Trait enabled investigators to assign participants to two groups: LOW ANXIETY (LA) and     HIGH ANXIETY (HA). The investigators evaluated physiological parameters (heart rate, skin     conductance, temperature in the extremities, electromyogram of the frontal muscle and     salivary cortisol) and vocal parameters (vocal self-evaluation, quality of life in voice and     vocal symptoms and signs) BEFORE, DURING and AFTER the SPS.   "
252250|NCT01157286|"     The investigators intend to study the prevalence of obstructive apnea in patients submitted     to partial laryngectomy by larynx cancer. Volunteers will be evaluated using polissonografy.     We will try to correlate the residual glotic area with the number of apneas per hour.   "
252251|NCT01157299|"     The purpose of this study is        -  To assess the value of dynamics (SVV, PPV) and static indices (GEDVI, ITBVI, CVP) of          preload and its combination with contractility (CI,SV, ventricular power, dP/dtmax, CFI,          GEF) and lung water indices (ELWI), as predictors of fluid responsiveness in both          spontaneously breathing and mechanically ventilated pediatric patients.        -  To assess the value of stroke volume and pulse pressure changes from femoral pulse          contour analysis (PiCCO2) during passive leg raising as predictor of fluid          responsiveness in pediatric patients.        -  To establish normal and cutoff values of transpulmonary thermodilution (PiCCO2)          hemodynamic variables in hemodynamically stables and hemodynamically normal patients.   "
252252|NCT01157312|"     The purpose of this study is to compare and determine the the efficacy of minimal stimulation     and clomiphene citrate(CC) as the first-line treatment in infertile women with Polycystic     Ovary Syndrome(PCOS).   "
252253|NCT01157325|"     Currently, it is certain that neuraxial analgesia in early stage of labor and delivery dose     not increase the risk of Cesarean section. However, given ethical reasons, whether such a     medical procedure could increase the Cesarean rate compared with those who did not received     neuraxial analgesia or not is yet to be known. It is difficult to perform such a study in     occidental countries because they have a higher rate of labor analgesia. On the contrary, the     rate of labor analgesia in China is up to date only 1%, so it can be done easily. The     investigators hypothesized that no neuraxial analgesia itself were a risk factor to Cesarean     section. Therefore, the investigators design this study to compared the effect of neuraxial     analgesia on the rate of Cesarean delivery with those who did not received neuraxial     analgesia.   "
252254|NCT01157338|"     Retinal emboli is a common phenomenon in cardiac catheterization. In this study the     investigators evaluate the incidence of retinal emboli post diagnostic and therapeutic     cardiac catheterization over 300 patients. The incidence was 6.3% and had no clinical sequel     on visual acuity and visual field.   "
252255|NCT01157351|"     The study will assess the use of paliperidone palmitate compared with oral antipsychotic     treatment in delaying time to a protocol-defined treatment failure over 15 months, in     patients diagnosed with schizophrenia who have been incarcerated.   "
252256|NCT01157364|"     This study will evaluate the safety and efficacy of new ophthalmic formulations of     bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3     formulations will be evaluated based on internal data review of each cohort. The study will     be conducted in 2 stages. Stage 1 is open-label and Stage 2 is masked.   "
252257|NCT01157377|"     This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic     overactive bladder (IOAB) and urinary incontinence.   "
252258|NCT01157390|"     Objective: To demonstrate the well-being of Chinese term infants fed with Wondersun formula     with high proportion of palmitic acid in the sn-2 position.      Design & setting: A single-center, open label study. A breast fed group will serve as     reference. The study will be conducted in Guangzhou from 2010.1~2010.12.      Participants: 0-14 d whole formula-fed infants and whole breast-fed infants, 30 infants in     each group. They are required to be healthy, term-infant, and with normal birth weight, and     have no medications known to affect their growth and development.      Intervention: The formula-fed infants will be fed Wondersun formula with high proportion of     palmitic acid in the sn-2 position; and breast-fed groups will be fed using breast milk for     at least 3 month.      Outcome measures: Tolerance and efficacy will be assessed by body measurement, stool     characteristics questionnaire, general health examination, and behavior and habit     questionnaire at baseline (0-14d), 6 weeks and 12 weeks. Safety will also be evaluated.      Statistical analysis: t-test, rank test and chi-square test will be used to examine the     significance of change from baseline to follow-up visit between the formula-fed and     breast-fed groups for effectiveness measures   "
252259|NCT01157403|"     Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the     pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to     control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been     shown in many animal studies their potential cure for T1DM,which could not only address the     need for β-cell replacement but also control of the autoimmune response to cells which     express insulin. Therefore it is need to study the safety and efficacy of autologous bone     marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.   "
252260|NCT01157416|"     The purpose of this study is to show whether D-cycloserine in combination with cognitive     behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of     posttraumatic stress disorder (PTSD) in 7-12 year old children.   "
252261|NCT01157429|"     The purpose of this study is to show whether D-cycloserine in combination with cognitive     behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of     posttraumatic stress disorder (PTSD) in 13-18 year-old children.   "
252296|NCT01158131|"     Many studies have shown that women with a history of gestational diabetes mellitus (GDM) have     an increased risk of developing diabetes later in life. The purpose of the study is to test     whether a web-based lifestyle intervention program adapted from the NIH sponsored Diabetes     Prevention Program (DPP), modified specifically for women with a recent history of GDM,     incorporating advice about diet and physical activity, delivered in the first 12 months after     delivery will help women lose weight, improve overall health, and decrease their risk factors     for type 2 diabetes.   "
252262|NCT01157442|"     Optimal development of sustainable health systems must use locally relevant infrastructure.     Mobile phone technology, driven primarily by local market forces rather than foreign     assistance, is spreading rapidly through African communities to improve people's personal and     business communications. Here, the investigators propose using a structured mobile phone     communications system for prevention of mother to child transmission of HIV (PMTCT). The     system is designed to improve antenatal linkage to care, provide reminders to take PMTCT     medications, and improve post-natal support and follow-up, even when mothers deliver at home.     In addition to benefits in PMTCT related outcomes, this model allows evaluation of the     intervention in a public health setting with the ultimate goal of advancing regional health     systems development. The overall goal of of the study is to assess if mobile phones and SMS     text messages can be used to help improve prevention of maternal to child transmission     (PMTCT) of HIV services by strengthening health systems.      Specific objectives are:      1. To determine if mobile phone SMS text messages can demonstrate an improvement in     compliance with a known intervention ( use of nevirapine) for PMTCT, demonstrated by:      1a) improved antenatal care attendance (greater than 4 visits)      1b) increased usage of nevirapine in labour (from 60% to at least 70%)      1c) earlier identification and treatment of HIV positive infants      1d) increased postpartum care for HIV positive mothers      1e) acceptability of cell phone SMS text messages transmission of information among HIV     positive women      2. To demonstrate that mobile phone technology can be used as an effective tool to strengthen     PMTCT health information systems at the facility level by: 2a) determining factors that     constrain or promote the use of cell phone technology to strengthen PMTCT health information     systems from the perspective of patients, health care providers and policy makers 2b)     determining how cell phones can be used as a tool to generate equity statistics for PMTCT     programs and formulate equity orientated PMTCT policies 2c) determine if early involvement of     policy makers in the study improves knowledge translation   "
252263|NCT01157455|"     This is a prospective, multi-center registry to evaluate safety and effectiveness of the     Everolimus Drug Eluting Stent for treatment coronary revascularization in Chinese patients     with long lesion, small vessel or multi-vessel diseases.   "
252264|NCT01157468|"     -  The Martinique island (French West-Indies) is an area of high prevalence and incidence          for Systemic Lupus Erythematosus (SLE), respectively 64,2/ 100000 and 4,7/ 100000. In          many cases, this disease concerns Afro Caribbean women, whose auto-antibodies are          excessively high; also, organic damages are frequent. The disease can be fatal.        -  Studies have shown that some cytotoxic auto-antibodies may have a responsibility in the          hydrolysing of DNA. This study will focus on the DNA activity and also on the overwhelm          hydrolase activity dealing with the Lupus disease in order to measure the link between          the disease activity and the catalytic activity. Patients concerned by this study will          be Martinique people.   "
252265|NCT01157481|"     Patients with heart failure with preserved ejection fraction have a equally high risk for     mortality and re-hospitalization as those with reduced ejection fraction. Effective     management strategies are critically needed to be established for this type of heart failure.     These patients have more hypertensive and ischemic etiology than those with reduced ejection     fraction. The investigators hypothesis is that Ca channel blocker nifedipine can improve the     heart failure clinical composite response endpoint compared with the conventional treatment     in patients with heart failure with hypertension and/or coronary artery disease and preserved     ejection fraction (>=50%) by echocardiography. This study is multi-center, prospective,     randomized, open-label, and blinded-endpoint design.   "
252266|NCT01157494|"     In recent years Ferrari et al. proposed a new classification of manipulation in children with     spastic hemiplegia which describes five different classes by analyzing and integrating the     kinematic patterns of the hand and its functional use.      The investigators believe that this classification provides the clinician with clinically     meaningful information, by identifying the useful strategies spontaneously adopted by the     children during manipulation tasks.      The aim of this study is to determine the criterion validity of the new classification of the     pattern of manipulation in children with spastic hemiplegia by correlating hand manipulation     classes with both the scores of the Assisting Hand Assessment and the scores of the Melbourne     Assessment of Unilateral Upper Limb Function.   "
252267|NCT01157507|"     Previous clinical observations showed that Botulinum A toxin (BoNT/A) has also an     antinociceptive effect and can control the neuropathic pain.      In the urologic field, recent in in vitro and in in vivo studies demonstrated that the     neurotoxin is able to inhibit the release of several neurotransmitters from the bladder     afferent fibers and urothelium. These neurotrasmitters as SP, CGRP, ATP, NGF and     Prostaglandins are involved in neurogenic inflammation. Thus, it is reasonable to hypothesize     that patients with affected by painful bladder syndrome (PBS) could benefit from BoNT/A     intravesically administered.      The aim of the study is to investigate the clinical and urodynamic effects of an intravesical     treatment with BoNT/A in patients affected by PBS associated with increased urinary     frequency, who are refractory to conventional treatments. This treatment will be compared to     bladder over distention, which is considered a conventional therapy.   "
252268|NCT01157520|"     Hypotension after spinal anesthesia for Cesarean section occurs in up to 90% usually under     five minutes after local anesthetics administration. These changes are poorly depicted by     oscillometric measurements. The investigators hypothesized, that a continuous noninvasive     device detects more hypotensive periods with lower blood pressures.   "
252269|NCT01157533|"     The goal of this clinical research study is to learn if giving a larger than normal loading     dose of the antibiotic vancomycin before starting standard vancomycin dosing can help     patients reach and maintain the needed blood-level of the antibiotic during treatment.   "
252270|NCT01157546|"     This is a prospective, double blind, randomized study is proposed in patients undergoing open     radical prostatectomy: its objective is to establish whether continuous bilateral TAP blocks     would provide adequate perioperative analgesia, decrease opioid consumption, reduce the     incidence of opioid-related side effects, and facilitate surgical recovery (in terms of PACU     and hospital discharge).   "
252271|NCT01157559|"     The aim of the study is to investigate the efficacy and safety of ziprasidone in patients     with first episode psychosis.   "
252272|NCT01157819|"     The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro (0.3%     Ciprofloxacin Otic Foam), used once-daily for 7 days for the treatment of Acute Diffuse     Otitis Externa, compared to commercial ear drops used twice daily for 7 days.   "
252297|NCT01158144|"     Concomitant chemoradiotherapy is the standard treatment of locally advanced, non-resectable,     non-small cell lung cancer (NSCLC). However, the optimal chemotherapy regimen is still     controversial. The purpose of this study was to evaluate the efficacy and toxicity of a     concomitant treatment using Endostar (Recombinant Human Endostatin), Paclitaxel/Carboplatin     and radiotherapy for LA-NSCLC, and also assess its impact on patient Quality of Life (QoL)     and progression-free survival (PFS).   "
252273|NCT01157832|"     Title: The acute effect of water pipe smoking on exhaled nitric oxide (eNO) and exhaled     breath condensate (EBC) pulmonary function tests in healthy volunteers      Objectives: To evaluate the acute effect of one cession of water pipe smoking on airway     inflammation as assessed by exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) in     healthy volunteers.      Design: Prospective study evaluating these parameters before and after 30 minutes of water     pipe smoking . The changes in inflammatory parameters pre and post smoking will be evaluated     blindly.      Sample size: 100 participants Participant selection: Adults subjects who regularly smoke     water pipe . Intervention: Each subject will undergo evaluation including a respiratory     questionnaire , pulmonary function tests , exhaled nitric oxide (eNO) and exhaled breath     condensate (EBC) and carboxy- hemoglobin levels . All measurements will be evaluated before     and after one cession of 30 minutes water pipe smoking      Primary outcome parameter: Change in carboxy- hemoglobin Secondary outcome parameter:Change     in peripheral eosinophils count, pulmonary function tests, change in FeNO, and in     inflammatory parameters in EBC before and after water pipe smoking   "
252274|NCT01157845|"     The methacetin breath test (MBT) is a non-invasive liver function test which measures the     ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is     exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of     a decline in liver function in patients with cirrhosis who are awaiting liver     transplantation.   "
252275|NCT01157858|"     The aim of this study is to reduce polycystic liver volume by treating with octreotide,     whether or not combined with everolimus; to assess whether combination therapy of everolimus     and octreotide gives a bigger reduction of polycystic liver volume than octreotide     monotherapy.   "
252276|NCT01157871|"     The primary objective is to assess safety and efficacy of two different doses of NV1FGF as     compared to placebo.      The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.   "
252277|NCT01157884|"     The graft survival in kidney transplantation has been improving after the introduction of new     immunosuppressive agents. Therefore, other complications after transplantation are concerned;     one of those is obesity. Several factors are attributable to obesity in kidney transplant     recipients.      The body composition such as fat mass and lean mass is important concept in overweight     patients. Some studies have been conducted on the change of body composition in kidney     transplants. However, all of them are studied among Caucasians or using dual energy X-ray     absorptiometry (DEXA).      In this study, the investigators plan to study the body composition among Asian kidney     transplant recipients using the bioelectrical impedance analysis (BIA).   "
252278|NCT01157897|"     This is a first-in-humans safety, immunogenicity and efficacy study with recombinant     proteinVMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open     label study will be performed in malaria-naïve adults in the United States. Three doses of     VMP001 formulated in AS01B will be given intramuscularly at different intervals followed by a     challenge with P. vivax infected mosquitoes. Safety, immunogenicity and efficacy parameters     will be studied.   "
252279|NCT01157910|"     Children with chronic otitis media have more resistant bacteria that require surgical     intervention to eradicate the infections. The study will evaluate the dominant bacteria and     their sensitivities to antibiotics. The information will assist in better treatment plans for     children with chronic infections.      The data will also assess the changing patterns in the bacteria colonizing middle ear fluid.   "
252490|NCT01160380|"     The purpose of this study is to evaluate the efficacy of armodafinil for the treatment of     cancer-related fatigue in adult patients with multiple myeloma. The study consists of a     screening period, followed by a 56-day treatment phase, and a final assessment to occur 28     days after the end of the last treatment.   "
252280|NCT01157923|"     Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to     the standard of care of patients with type 1 diabetes.      The objective of this feasibility study is to evaluate the efficacy and safety of automated     determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration     and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1     diabetes.The study will be consisted from two segments:(I)pilot study, 30-78 days trial     evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing     MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to     enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment,     the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for     dropouts.      The randomized controled study segment will be initiated after the pilot segment.Each segment     of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of     30-78 days study duration for each segment. Before each clinic visit, subjects will wear     continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations     (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period     according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin     pump settings will not be changed during the study period (patient's usual standard of care).   "
252281|NCT01157936|"     The purpose of this study is to evaluate the influence of hyperuricemia treatment compared     with placebo on participants with high risk of hypertension and metabolic syndrome.   "
252298|NCT01158157|"     The purpose of this study is to vaccinate plasma donors with ACAM2000(TM) smallpox vaccine     for collection of plasma to be used in the manufacture of Vaccinia Immune Globulin     Intravenous (VIGIV).   "
252299|NCT01158170|"     RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in     patients with advanced non-small cell lung cancer. It is not yet known whether radiation     therapy is more effective than observation in patients with advanced non-small cell lung     cancer.      PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see     how well it works compared with observation in preventing brain metastases in patients with     advanced non-small cell lung cancer   "
252300|NCT01158183|"     A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS)     population capturing outcomes reported by patients and by the physicians during 12 months     after initiating or resuming Betaseron.   "
252301|NCT01158196|"     A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a     randomization of laser treated portions, and other with keloid excision scar with a complete     laser treatment. The aim is to evaluate the infra-red diode laser influence on keloid     recurrence and scar prevention. The keloid recurrence rate will be evaluated at each visit,     and the scar prevention in plastic surgery will be evaluated comparing laser treated portion     and non-treated portion.   "
252282|NCT01157949|"     The purpose of this study is to test the hypothesis that administering Thymoglobulin®     induction therapy early after transplant prevents the development of cardiac allograft     vasculopathy (CAV). CAV accounts for a significant number of deaths in cardiac recipients     after the first year of transplant. At 5 years post-transplant 30% of the deaths are due to     CAV. With the exception of re-transplantation the available treatments for CAV are only     effective at inhibiting its progression.      CAV involves only the allograft and spares the native arteries, suggesting an immunologic     basis for the disease. However, both immunological and non-immunological factors contribute     to the development of CAV. The established immunological risk factors are recurrent rejection     and humoral/antibody-mediated rejection (AMR). Non-immunological risk factors identified     include preservation injury, the cause of donor death, donor graft ischemic time, and     cytomegalovirus infection1. It is hypothesized that these factors increase the risk of     developing CAV by causing early endothelial damage to the graft, which then could promote     increased lymphocyte-endothelial interactions and the production of anti-endothelial     antibodies2. The investigators hypothesized that Thymoglobulin induction therapy would     prevent the development of CAV because its polyclonal nature allows Thymoglobulin to target     all the potential mechanisms that contribute to the development of CAV—T-cell activation,     B-cell activation, antibody formation, induction of tolerance, and modulation of     lymphocyte-endothelium interactions3. Because the mechanism by which Thymoglobulin affects     the immune system are still poorly understood, the investigators will also study how     Thymoglobulin changes the immune system over time in the heart transplant recipient as a     secondary objective.   "
252283|NCT01157962|"     Aim of present study is to inspect, if the removal alone of sentinel lymph nodes in women     with early Cervix Carcinoma lead to, at equal length, overall survival like entire systematic     dissection of lymph node and at the same time is accompanied with a considerably reduction of     associated intra and post operative complications of lymph node dissection.      For this purpose were randomized about 1200 patients with histological assured cervix     carcinoma in stages FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, FIGO1b1 L0 or L1 V0= 2 cm     randomization. In the branch A takes place exclusively dissection sentinel lymph node, in the     branch B takes place entire pelvic lymph node dissection. Afterwards takes place in tumor     free lymph nodes the removal of uterus by a radical hysterectomy or, in presence of the wish     of children, radical trachelectomy. In affected tumoural lymph nodes takes place systematic     pelvic and peri aortic lymph node dissection followed by primary Radiochemotherapy.      Primary end point is overall survival; this for both groups must be equal. Secondary end     point is peri- and postoperative morbidity inclusive quality of life, the benefits for women     must be evident with sentinel- lymph node dissection, don't have to show for both groups any     significant difference.   "
252284|NCT01157975|"     Patients with chronic hepatitis C viral infection (HCV) and with a BMI greater than 25Kg/m2     are refractory to medical treatment. Also, HCV replication seems to be affected when modeling     insulin resistance in replicon cell culture systems.      PPARg -agonist (Pioglitazone) is effective in controlling liver inflammation in obese     subjects with non-alcoholic steatohepatitis (NASH) and also improving insulin sensitivity.     Therefore, we hypothesize that improving insulin resistance and /or inflammation may affect     HCV replication and viral kinetics. Independently of PPARg pathways, Prednisone may increase     HCV viral kinetics. .   "
252285|NCT01157988|"     This phase II study is aimed at the clinical efficacy and toxicity of 6th R-CHOP chemotherapy     followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage,     bulky diffuse large B cell lymphoma (DLBCL).   "
252286|NCT01158001|"     The objective of the proposed study is to conduct a systematic comparison of post traumatic     stress disorder (PTSD) outcomes for veterans receiving exposure therapy via telemedicine     versus in-person care. The primary aim is to determine feasibility: whether telemedicine can     be used as a tool to extend effective, specialized mental health services, such as Prolonged     Exposure therapy (PE; a therapy designed to help clients face fears related to a traumatic     event), to veterans with limited access to care. A secondary aim is to determine if therapy     delivered by telemedicine affects the quality of care in terms of clinical outcomes and the     quality of patient-therapist interaction. A tertiary aim is to examine whether results from     neuropsychological testing predict treatment outcomes.   "
252287|NCT01158014|"     The use of Fibrin glue to place conjunctival graft will be as effective as suturing the     graft, but will require much less operative time and will be better tolerated by the     patients.   "
252288|NCT01158027|"     The goal of the present study is to look at the effect of changing walking parameters on the     dynamic walking characteristics among children post severe traumatic brain injury, and     typically developed controls.   "
252289|NCT01158040|"     The purpose of this study is to compare intrapartum glycemic control using insulin pump     versus intravenous (IV) insulin administration.   "
252290|NCT01158053|"     The present prospective, multicenter study will therefore be performed with the primary     objective of establishing the correlation between fractional flow reserve (FFR) and     intravascular ultrasound with virtual histology (VH-IVUS)-derived parameters in     angiographically intermediate coronary lesions. The current study will also examine the     relative prognostic utility of FFR and VH-IVUS as a tool to defer percutaneous coronary     intervention (PCI), by assessing the long-term rate (up to 3 years) of lesion-related     clinical events if deferred by FFR vs. VH-IVUS versus not deferred PCI.   "
252291|NCT01158066|"     Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general     population and are being considered the most common cause of death. Cardiac CT is a reliable     non invasive method in demonstrating Coronary Plaques. However the association between     coronary artery calcium score (CAC) and NAFLD remains controversial   "
252292|NCT01158079|"     This study provides a mechanism for continued administration of ALN-VSP02 therapy to patients     with cancer who completed participation in another ALN-VSP02 clinical study. The primary     objective of this study is to collect long term safety data.   "
252293|NCT01158092|"     The purpose of this study is to evaluate the effectiveness of cooled radiofrequency     denervation of the sacroiliac region using the SInergy System compared to conservative     treatment in the treatment of sacroiliac joint pain.   "
252294|NCT01158105|"     The purpose of this study is to see if bortezomib (Velcade) is effective in the treatment of     refractory cGVHD.   "
252304|NCT01158235|"     This is a pilot study conducted to evaluate the safety, local tolerability and efficacy of     LTX-109(Lytixar™), a lytic peptide designed to kill bacterias quickly and efficient. LTX-109     (Lytixar™)will be applied in the anterior nares in subjects who are carriers of nasal     colonies of MRSA/MSSA.      The extent of systemic absorption of LTX -109 when applied to the anterior nares will be     evaluated and the effect of Lytixar™ as to clear colonies of MRSA/MSSA during the the     observation period and Week 2 to Week 9 after treatment.   "
252305|NCT01158248|"     RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     tumor cells. Giving panitumumab and cisplatin together with pelvic radiation therapy may be     effective in treating patients with cervical cancer.      PURPOSE: This phase II trial is studying the side effects of giving panitumumab and cisplatin     together with pelvic radiation therapy in treating patients with stage IB, stage II, or stage     III cervical cancer.   "
252306|NCT01158261|"     The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study     is to observe the clinical safety performance of EVICEL when used as suture support for     haemostasis in vascular surgery.   "
252307|NCT01158274|"     This phase I clinical trial is studying the side effects and best dose of RO4929097 when     given together with capecitabine in treating patients with refractory solid tumors. RO4929097     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving RO4929097 together with     chemotherapy may kill more tumor cells.   "
252308|NCT01158287|"     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating     patients with relapsed esophageal cancer and/or stomach cancer.   "
252309|NCT01158300|"     RATIONALE: PTC299 may stop the growth of tumor cells by blocking blood flow to the tumor.      PURPOSE: This phase I trial is studying the side effects and the best dose of PTC299 in     treating young patients with recurrent or refractory primary central nervous system tumors.   "
252310|NCT01158313|"     Previous studies have shown that most patients with functional oropharyngeal dysphagia could     be quickly, safely and accurately recognized by using a clinical bedside method developed by     the investigative team as the volume-viscosity swallow test (V-VST) that systematically     evaluates the main clinical signs and symptoms of safety and efficacy of swallowing and     monitors pulse oximetry to improve the detection of patients with silent aspirations.The aim     of this study is to validate this test for persons suspected of having swallowing impairment,     using a new thickener, with respect to the Videofluoroscopy (VFS) method (treated as the gold     standard).   "
252352|NCT01158885|"     This study will test the ability of clofarabine + cytarabine to eliminate minimal residual     disease (MRD) in acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL)     patients whose bone marrows exhibit complete remission by morphology. The toxicity profile of     this regimen will be evaluated in addition to toxicity experienced by patients who proceed to     stem cell transplant. Overall length of remission will also be collected.   "
252311|NCT01158326|"     This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol,     chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the     common cold. There will be a randomized, double-blind, placebo-controlled trial. Will be     included 216 subjects, male or female, aged greater than 12 and less than or equal to 60     years, irrespective of color and / or race with symptoms of recent onset, for more than 6     hours and less than 48 hours length, characterizing Common Cold and / or Influenza.      After clinical evaluation and laboratory research subjects will be randomized to receive     active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. The follow-up visits     will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first     intervention).      The outcomes to assess the effectiveness so far consist of the scores of symptoms and to     assess the safety of the drug will be accompanied by the emergence of adverse events.   "
252312|NCT01158339|"     Unspecific low back pain (LBP) is a major world wide health problem. The purpose of this     study is to improve the care of LBP.      Our hypothesis is that Cognitive Behavioural Therapy (CBT) with physical intervention during     group sessions focusing on fear and avoidance behaviour will be more effective than physical     therapy alone.      The study has two arms. Both will receive education related to LBP and appropriate advice     regarding how to react and behave towards their LBP.      The main focus in the intervention group will be:        -  Identifying their fear of movements and perform the frightened movements during the          group sessions.        -  Reassuring that gradually normalizing daily activities will not be harmful but rather          reduce their pain.   "
252313|NCT01158352|"     Study design:      Double blind, randomized, placebo controlled study.The proposed study will consist of two     main segments:        1. Segment 1 is aimed to assess the effect of 6-12 months treatment with nutritional          supplementation standardized formula, in short and lean prepubertal children on weight          SDS, height SDS, BMI SDS and growth velocity        2. Segment 2 is aimed to explore the eating behavior of idiopathic short stature and lean          prepubertal children against their sibling who have a normal height and body weight and          to find out whether there is a difference in eating patterns and quality of life between          idiopathic short stature and lean prepubertal children and children with normal height          and body weight      Segment 1      Population:      200 subjects and controls will be recruited to segment 1 of the proposed study, 100 at each     group.      Participants will be recruited from healthy children who will be referred to either the     institute for endocrinology or the gastroenterology unit, at Schneider Children's Medical     Center for growth assessment, due to low height and weight, in whom, no gastrointestinal     morbidity or other underlying cause was found.      Methods:      Randomization & Blinding:      Participants will be randomly assigned either to the intervention group or the placebo     control group. Randomization for the two study groups will be made in a ratio of 1:1. Both     participants and study team will be blinded to the type of treatment that each patient will     receive during the first 6 months of the study.      Treatment:      Participants in the intervention group will be treated with a nutritional supplementation     standardized formula.Participants in the control group will be instructed to consume the same     volume of formula as was calculated if they were in the intervention group.      Treatment duration:      The study will be divided into two treatment periods: 6 months of intervention versus active     placebo followed with additional 6 months (an extension period), in which participants at the     intervention group will be offered to extend the intervention period and participants at the     control arm will be offered to switch to the intervention group.      Study Schedule:      Follow up visits will take place at 0, 3, 6, 9 and 12 months and will include:        1. Demographic data, medical history and growth data (month 0):           Demographic parameters, including birth date, gender, birth weight and length for          gestational age, medical history and growth data, including height velocity, parent's          and sibling's weight and height will be documented from patient's file.        2. Nutritional assessment        3. Anthropometric assessment (months 0, 3, 6, 9 12):             1. Height without shoes             2. Length             3. Weight with light cloths and without shoes             4. MAC             5. Body mass index (BMI) will be calculated from children's weight and height and age               and gender specific BMI SDS will be calculated             6. Body composition assessment using the method of bioelectrical impedance        4. Laboratory parameters (months 0, 6 and 12):        5. Sleeping Questionaire      Segment 2:      86 subjects and controls will be recruited to segment 2 of the proposed study      Population:      Short and lean prepubertal children participating at segment 1 of the study and who are at     study entry under 10th percentile in height, when the weight percentile is equal or smaller     to the height percentile. Only participants from segment 1 who have siblings with normal     height and body weight for age and gender, will be able to participate in segment 2 of the     study      Control group 1:      Sibling of participants in segment 1 of the study, who have a normal height- above 25th     percentile and normal BMI for age and gender- above 5th percentile and under 85th percentile.      Control group 2:      Healthy children from the community who have a normal height above 25th percentile and normal     BMI for age and gender above 5th percentile and under 85th percentile      Segment 2 of the study will be designed as a case- control study and will focus on the eating     patterns, sleeping patterns and quality of life of participants at segment 1 at time 0 month     of the study, before the beginning of the nutrition intervention. These findings will be     compared to data of a control group, which will be comprised of siblings of participants in     segment 1, with normal height and body weight which are matched in age.   "
252314|NCT01158365|"     Primary Objective:      - To prove the efficacy superiority in reducing the genital odor and increase hydration in     mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal     Soap Granado Traditional      Secondary Objective:      - To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.   "
252315|NCT01158378|"     The purpose of the study is to demonstrate the safety and effectiveness of the Adherus Dural     Sealant System when used as a dural sealant in conjunction with standard methods of dural     repair in cranial procedures.   "
252316|NCT01158391|"     The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age)     who undergo the NTrainer System® training will transition to full oral feeds faster than the     control group (i.e. the study group will be superior to the control).      The secondary hypothesis is that the infants in the NTrainer System® experimental group will     have shorter lengths of stay.   "
252317|NCT01158404|"     The objective of this phase 1 study is to evaluate the safety and tolerability of Notch     Inhibitor in patients with advanced cancer. This study includes dose escalation and dose     confirmation components.   "
252373|NCT01159171|"     This study will assess the efficacy and safety of treatment with the combination Avastin     (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14     of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally     advanced or metastatic colorectal cancer. The anticipated time on study treatment is until     disease progression.   "
252318|NCT01158417|"     The main objective of this study is to investigate the effect of resveratrol on inflammatory     mediators and insulin resistance at the cellular and molecular level in obese non diabetic     and type 2 diabetic subjects in vivo. This research will investigate the hypothesis that     resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in     reactive oxygen species (ROS) generation and the pro-inflammatory transcription factor     nuclear factor-kB (NF-kB) and the inflammatory mediators regulated by it. The hypothesis that     resveratrol suppresses the high fat, high carbohydrate (HFHC) meal induced inflammatory and     oxidative response, will also be investigated. This research will also investigate the     hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the     Homeostasis model assessment of insulin resistance (HOMA-IR), an index of insulin resistance     and, that resveratrol intake will cause an increase in incretins.   "
252319|NCT01158430|"     The purpose of this study is to determine the effect of Acceptance and Commitment Therapy     (ACT) in groups on functional level, emotional problems, and use of health care in patients     with severe health anxiety in a randomized, controlled design.   "
252320|NCT01158443|"     This is an integrated medication/behavioral intervention program to increase energy, activity     level and goal attainment in a sample of HIV+ adults whose presenting problems include both     clinically significant fatigue and unmet vocational goals. Based on previous studies, the     investigators found that many patients fail to achieve desired goals even though energy is     restored by medication. To address this failure of goal attainment, the investigators will     evaluate a behavioral intervention, originally based on Behavioral Activation Treatment for     Depression, and modified as Behavioral Activation Program for Energy and Productivity or     BA-PEP. The intervention will be conducted with patients who experience clinically     significant fatigue and who want to work or receive work-related training (paid or volunteer,     part time or full time) or education once energy improves with medication (armodafinil).   "
252321|NCT01158456|"     Metabolism and DNA adduct formation are critical in cancer induction by NNK. The     investigators goal is to understand whether the observed ethnic/racial differences in lung     cancer incidence are due to variations in NNK metabolism. The investigators overall     hypothesis is that cancer susceptibility relates to carcinogen dose and to the balance     between carcinogen metabolic activation and detoxification. The investigators propose to test     this hypothesis via investigation of potential differences in NNK metabolic activation and     detoxification in African American and European American smokers.   "
252322|NCT01158482|"     A data registry for all patients who undergo IVC (Inferior Vena Cava) filter placement or     retrieval at Stanford. Potential enrollees will already be undergoing the procedure. If     patients are willing, they will be prospectively enrolled prior to the procedure. As part of     the study, chart and clinical data reviews will be used to track patient progress and     response to the treatment.   "
252323|NCT01158495|"     To implement a new method of performing chest CT imaging in young children at Packard     Children's Hospital entitled controlled ventilation infant/young child chest CT scanning.     This technique will be used to evaluate early lung disease comparing quantitative chest CT     air trapping and airway measurements with lung function measurements in infants, toddlers,     and young children with chronic lung disease.   "
252324|NCT01158508|"     Rupture of brain aneurysms is a common cause of death and disability, accounting for as many     as 10% of stroke cases in the United States. While much of the resulting injury to the     nervous system is caused by the initial bleeding from the aneurysm, many of these patients     develop cerebral vasospasm, pathological constriction of the blood vessels supplying the     brain, several days following hemorrhage. As many as a third of patients can suffer a     resulting neurological deficit and stroke, presumably caused by the decreased blood flow to     the brain (ischemia). This delayed brain injury accounts for a significant percentage of poor     outcomes following aneurysm rupture. Studies have shown that remote ischemia to many organs     can precondition other tissues (including the brain) to be more tolerant to decreases in     blood flow. This remote ischemic preconditioning has the promise of protecting the brain     from ischemic injury. Whereas in other forms of stroke the onset of ischemia cannot be     predicted in the general population, following aneurysm rupture the investigators know which     patients are likely to develop vasospasm and when. Therefore, ischemic preconditioning     following aneurysm rupture may help prevent some of the ischemic injury caused by vasospasm.     Remote ischemic preconditioning by transient limb ischemia (produced by inflation of a blood     pressure cuff on the arm or leg) has been shown to minimize injury to other organs, most     notably the heart. Remote ischemic preconditioning of the brain following aneurysm rupture     has not yet been investigated.   "
252325|NCT01158521|"     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Giving pazopanib hydrochloride before surgery may make the     tumor smaller and reduce the amount of normal tissue that needs to be removed.      PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works when given     before surgery in treating patients with kidney cancer.   "
252326|NCT01158534|"     RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Recombinant interferon alfa-2b may interfere with the growth of     cancer cells and slow the growth of kidney cancer. Giving celecoxib together with recombinant     interferon alpha-2b may kill more tumor cells and be an effective treatment for metastatic     kidney cancer.      PURPOSE: This phase II trial is studying how well giving celecoxib together with recombinant     interferon alfa-2b works in treating patients with metastatic kidney cancer who have     undergone surgery.   "
252327|NCT01158547|"     The purpose of this study is to assess the ability of CLR3001 to reverse depressive symptoms     relatively quickly in adult patients with major depressive disorder (MDD).   "
252328|NCT01158560|"     The specific objectives of this investigation are to assess the effectiveness of daily     gargling and vitamin D supplementation as preventative measures against incident upper     respiratory tract infection (URTI) in students attending McMaster University. Investigators     hypothesize that        1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory          tract infections in university students        2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections          in university students.   "
252329|NCT01158573|"     The purpose of this study is to examine whether there are higher levels of cysteinyl     leukotrienes in obese subjects than in non-obese subjects. Cysteinyl leukotrienes are     pro-inflammatory substances that cause asthma by narrowing the airways of the lung. The     investigators want to see if subjects with increased fat stores and therefore increased     leptin, which is a fat-related protein that regulates leukotrienes, have increased levels of     leukotrienes in the blood, lung and urine. The investigators would also like to determine the     relationship between cysteinyl leukotrienes and exhaled nitric oxide levels in asthmatics     with and without obesity. Nitric oxide is anti-inflammatory and suppresses leukotriene     synthesis.   "
252330|NCT01158586|"     Postoperative epidural analgesia (EA) is an effective and well-accepted modality of pain     relief technique after having total knee replacement operation(1,4). Patient controlled     epidural analgesia (PCEA) has been shown to be safe and effective in standard ward setting(2)     and results in reduced epidural analgesic requirements(3). Besides, it also bear the     advantage of avoidance of overdose, reduction of waiting times and involvement of patients in     their analgesic regimen(3). Both ropivacaine and levobupivacaine are the local anaesthetic     using in epidural analgesia which has been proven to be safe and effective(4). 0.2%     Ropivacaine with 2ug/ml fentanyl has been used in our locality for more than 8 years. Another     local anaesthetics, levobupivacaine, a S-enantiomer of bupivacaine has come up in Hong Kong,     which has been proved to be safe, effective and may be better value for money. These two     drugs has been proven to have similar analgesic potency in using as EA for postoperative pain     relief for other operation(5,6,7) and for orthropaedics operation but in different     concentration(4). Concerns have been raised about the introduction of the levobupivacaine in     the departmental protocol. Objectives of this study are A)to determine the equivalence of two     local anaesthetics regimen ; 0.2% ropivacaine with 2ug/ml fentanyl and 0.2% levobupivacaine     with 2ug/ml fentanyl and B) to assess the cost-effectiveness of using these two regimens.      The null hypothesis is that the difference of analgesic effect, presented with visual     analogue score, of two patient controlled epidural analgesia regimen, the 0.2% ropivacaine     with 2 ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl is higher than the     threshold of 9 mm VAS. (8,9,10)   "
252331|NCT01158599|"     This is an open-label, uncontrolled phase 4 study to assess the safety and immunogenicity of     the Japanese encephalitis (JE) vaccine Ixiaro® (IC51) in an elderly population.   "
252332|NCT01158612|"     Tendon and ligament injuries are a frequent problem among athletes but also in the general     population. The healing process is a prolonged process, and complete recovery of tissue     strength is nearly never reached. The purpose of this study is to examine the effect of local     injection of human Growth Hormone on tendon collagen synthesis.   "
252333|NCT01158625|"     The purpose of this study is to investigate if it is possible to lower the nighttime blood     pressure in patients with type 2 diabetes mellitus by shifting the administration of     antihypertensive drugs from morning to nighttime.   "
252334|NCT01158638|"     Individually tailored, mediated pedometer feedback will provide an effective method to     promote physical activity adoption in the elderly   "
252353|NCT01158898|"     This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the     efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days     for the treatment of allergic asthma and allergen-induced asthma.   "
252335|NCT01158651|"     The purpose of this research study is to learn if the study drug RAD001 can shrink or slow     the growth of low-grade gliomas in children with NF1. Additionally, the safety of RAD001 will     be studied.      The study drug, RAD001, is a drug that may act directly on tumor cells by preventing tumor     cell growth and development. RAD001 has been studied in participants with various types of     cancer as a single agent (a drug that is used alone to treat the cancer) or in combination     with a number of well known anticancer therapies. Information from these research studies     suggests that RAD001 may help to shrink or slow the growth of low-grade gliomas.      In this research study, the investigators are looking to see the response of RAD001 in     children with low-grade gliomas and NF1 that have either not responded to treatment or have     come back after treatment. We are also looking for the highest dose of RAD001 that can be     given safely in this patient population.   "
252336|NCT01158664|"     Patients who need more than 2 dental implants will be treated by the same implant type     (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en     1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is     registered around these implants. The role of the thread pitch design will be investigated.   "
252337|NCT01158677|"     Short term outcome after meniscectomy: a meniscectomy is a very frequent performed     orthopedically procedure. The short term outcome is favourable, but some patients keep having     residual lesions after surgery.      This prospective study examens the clinical outcome after meniscectomy using questionnaires     (KOOS, VAS, SF-36, Tegner) (before the surgery, 3, 6 & 12 months postoperative.) The     investigators will also record the further treatment options for the people at risk.   "
252338|NCT01158690|"     The study composes of two large parts, in particular a large scale prevalence/incidence study     and a single-blind randomised controlled trial (RCT). The prevalence/incidence study aims to     determine the prevalence/incidence of physical, psychological and sexual violence in a     pregnant population. The study population is recruited through the prenatal consultation of     more or less 15 hospitals in Belgium. The respondents fill out a questionnaire on the spot     minimum one time during pregnancy. Based on this questionnaire, the investigators aim to     recruit 150 victims of intimate partner violence (IPV) to participate in the second part of     the study. The RCT aims to evaluate if there is a safe and effective way to reduce IPV within     the perinatal care setting. The investigators hypothesise that screening pregnant women for     violence in combination with handing out a resource card, has the potential of interrupting     the IPV and increase help-seeking behaviour.   "
252339|NCT01158703|"     The design of the study will be randomized, double blind trial, which will examine the     effects of addition of clopidogrel to current guideline recommended background therapy on     lowering the incidence of graft stenosis after coronary artery bypass grafting compared to     placebo.   "
252340|NCT01158716|"     Elective percutaneous coronary intervention (PCI) is associated with troponin release in     approximately one third of cases. Myocardial necrosis may result from downstream embolization     of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion     injury. The investigators hypothesized that a single remote ischemic preconditioning cycle     would reduce peri-procedural troponin release.   "
252341|NCT01158729|"     A prospective, randomized, placebo-controlled, double-blinded pilot study is planned.     Neonates undergoing surgeries requiring cardiopulmonary bypass will receive antithrombin III     (ATIII) supplementation or placebo in addition to standard anticoagulation with heparin as     currently practiced at Children's Hospital of Wisconsin. We plan to enroll the first 60     sequential patients meeting criteria who consent to inclusion. The primary outcomes will be     rates of adverse events to monitor safety. Secondary outcomes include volume of postoperative     blood loss and packed red blood cell transfusion during the first 24 postoperative hours, and     ATIII levels during and after bypass to determine pharmacokinetics.   "
252342|NCT01158742|"     Kidney transplantation from living donors has been shown to carry many benefits over deceased     donor transplantation. Because of benefits such as shorter waiting times and improved outcome     for transplant recipients, living kidney donation accounts for an increasing number of kidney     transplants nationwide. Most published studies about living kidney donation demonstrate that     the procedure is safe, but they also emphasize concerns that long-term data on live donor     outcomes are insufficient. In particular, data concerning the extent of renal function     decline after donation are inadequate. This study will measure glomerular filtration rate     (GFR) in previous living donors and aims to more accurately describe renal function after     kidney donation.   "
252343|NCT01158755|"     Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, and is     diagnosed in approximately 5-10% of TB patients. The incidence of TBM has increased     considerably during the last decade, partly due to the HIV epidemic. Without treatment,     virtually all patients with TB meningitis will die. With the current treatment regimens, TBM     is fatal in approximately 30-50% of cases, and responsible for severe disability in a similar     proportion of survivors.      Worldwide, Indonesia the third highest case load of tuberculosis with an estimated 500,000     new patients / year. Representative data are lacking, but it is clear that TBM is a growing     problem. For instance, in Hasan Sadikin Hospital, the top-referral hospital for West Java     Province (population 40 million), Indonesia, 40-50 cases of TBM were treated yearly in the     late 90's compared to approximately 100 in recent years.      There is very little evidence for the current treatment regimen for TBM, which dates back to     the late 60's. Therefore, there is an urgent need to evaluate intensified treatment of TBM in     randomized trials. We hypothesize that higher dose rifampicin, moxifloxacin (possibly also at     high dose), or both will improve outcome of TBM. To determine the experimental regimen(s)     which should be compared with current regimen in phase 3 trials, we want to evaluate     pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical trial in 60     patients with TBM in Indonesia.   "
252364|NCT01159054|"     Patients with kidney failure on hemodialysis have an extremely high rate of cardiovascular     disease including atherosclerotic cardiovascular disease. This, at least in part, is due to     the chronic inflammatory status usually seen in these patients. Here we try to see if     treatment with extended release nicotinic acid (Niaspan) can reduce their overall     inflammatory burden (in general) and the atherosclerotic plaque inflammation (in particular).   "
255591|NCT03269773|"     This is multi-center, randomized, double-blind, parallel, placebo-controlled phase IIb     clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for severe and     refractory atopic dermatitis   "
252344|NCT01158768|"     Objectives - To construct and validate a questionnaire evaluating violence suffered by women     during any phase of their lives and health repercussions during climactery.      Method: A controlled study with the application of a questionnaire at the Outpatient Clinics     for Endocrine Gynecology and Climactery of the University Hospital (Hospital das Clínicas) of     the Medicine College of the University of São Paulo (FMUSP), Brazil, performed during 2009     for 124 women aged between 40 and 65 years, who were victims of domestic and/or sexual     violence, distributed in three groups regarding the phase in which their experience with     violence occurred: 1. Violence exclusively during childhood/adolescence; 2. During adulthood;     3. Throughout all phases. The instrument encompasses 13 key questions and 21 sub items     evaluating: 1. Place of residence and who the woman lives with; 2. Start, frequency and type     of violence; 3. Search for health assistance and report of the violence; 4. Violence and     number of affections; 5. Violence and Menopausal Kupermann Index (IMK).      Results: The instrument presented Cronbach Alpha=0.82, reliability among examiners (+0,80),     and good possibility to be reproduced. Average age of the women was 55,8 years (±6,6),     menopause at -45,4 years in average, in the control Group (GC) it was 48,1 years; first     sexual intercourse 19,5 years (GC = 21,0); menarche 13,1 years, and average BMI (Body Mass     Index) 28,5 (±2,8), similar to the GC, but frequent violence during adulthood showed a BMI of     30,0 (±2,8). Women who were submitted to violence exclusively: during childhood 14,5%;     adolescence 1,6%; adulthood 41,9%, during all phases of their lives 42,0%. Women subjected to     violence during childhood/adolescence (58,1%) presented an average of 5,1 affections; during     adulthood, 4,6 and 4,4 for both phases. Sexual violence (43,5%) and other types of violence     both present average affections (4,60) but represent a significative impairment of sexual     life. There were significative associations between suffering any type of violence during all     phases of their lives, sexual violence during any phase of their lives and a serious IMK.     Among those women, 80,6% did not search health services due to the violence suffered.      Conclusion: The questionnaire presents good internal consistency and a validated     construction, can be easily reproduced and is indicated to evaluate the consequences of     domestic and/or sexual violence on women´s health during climactery.   "
252345|NCT01158781|"     The purpose of this study is to restore life role participation for those with TBI by     customizing, applying, and testing integrated cognitive and motor training protocols that     were successful in populations with impairments similar to TBI. The treatment protocols are     based on principles of brain plasticity and re-learning, required to restore cognitive and     motor function. The intervention targets an array of impairments that are obstacles to life     role participation. These include cognitive attention and executive control; motor control     for upper limb function; balance and gait; and cognitive executive control of simultaneous     cognitive and motor tasks required by everyday tasks. The intervention utilizes training     specificity, framing the intervention within functional task and life role activity component     practice.   "
252346|NCT01158794|"     Iron overload, which can be defined operationally as too much iron in the body, develops as a     consequence of too many blood transfusions given, or due to genetic defects hereditary     hemochromatosis). Iron accumulates in several organs in the body, such as the heart, liver,     endocrine glands (pancreas, thyroid, etc.), and spleen. Excessive iron can damage organs and     may even cause death. Iron overload needs to be appropriately monitored and treated to avoid     unnecessary morbidity and mortality.      The present study, GENIOS, proposes to test prospectively the hypothesis that genetic     modifiers influence the iron overload status of patients receiving transfusions. To test this     hypothesis, the study will perform genetic studies to investigate possible genetic influences     for iron accumulation in the body and will study iron accumulation not only in the liver, but     also in the heart, pancreas, kidneys, and spleen. In addition: the study will investigate if     these same genes have any role during treatment of iron overload, in other words, if certain     genetic mutations will influence how iron exits the body. This study will also investigate     how substances that are known to control the trafficking of iron in and out of the body and     its damaging effects to the tissues (hepcidin and non transferrin-bound iron) are linked to     the accumulation of iron in the heart and liver. Iron in the body will be measured by R2*MRI     and no liver biopsies will be required. Genetic studies will be done by specialized tests     using peripheral blood DNA.      Iron accumulates differently in different people and in different organs of the body. Some     people accumulate iron faster than others, even when receiving the same number of blood     transfusions   "
252347|NCT01158807|"     This study is one of the three projects of an NIH Rare Disease Clinical Research Consortium.     A consortium is a group of centres sharing information and resources to perform research.     The consortium research focuses on brain blood vessel malformations in three different rare     diseases.      The focus of this specific study is on Hemorrhagic Telangiectasia (HHT).      HHT is a condition characterized by blood vessel malformations, called telangiectasia and     arteriovenous malformations (AVMs), occurring in the brain, nose, lungs, stomach, bowels and     liver. Brain AVMs (BAVMs) in HHT are difficult to study because they are rare, affecting     approximately 10% of people with HHT. While other types of BAVMs have been studied in depth,     studies in the HHT population have been very small. Here, we propose the first large-scale     collaboration by joining with 12 HHT Centers of Excellence in North America to perform a     large study of risk factors for bleeding from BAVMs, called intracranial hemorrhage (ICH) in     HHT patients.      The current standard of clinical practice across North America, is to screen all HHT patients     for BAVMs with magnetic resonance imaging (MRI). If BAVMs are detected, patients are referred     to a multidisciplinary neurovascular team for consideration for treatment. Treatment     decisions are made on a case by case basis, balancing risks of complications from the BAVM     with risks of therapy, but are limited by the few studies available in HHT. We hope that the     knowledge we obtain about the risk factors for intracranial bleeding in these patients from     this larger study will help us to improve the care of HHT patients.      We plan to study risk factors for rupture of BAVMs, including primarily genetics and imaging     characteristics of the BAVMs. Knowledge about risk factors will help in the care and     management of HHT patients. This will be achieved through the collection of health     information to construct a HHT database, blood sampling and banking (through the National     Institute of Neurological Disorders and Stroke [NINDS]), and through genetic analysis at the     University of California San Francisco.   "
252348|NCT01158820|"     This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the     use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in     less respiratory depression while providing better compliance with the procedure.   "
252349|NCT01158833|"     In recent years Ferrari et al. proposed a new classification of gait in diplegic children     with spastic diplegia that describes four different patterns of gait by analyzing the     strategies that each children adopts to need his/her needs to walk. The investigators believe     that this classification provides the clinician with clinically meaningful information in     terms of coping strategies adopted to maximize the ability to walk.      The aim of this study is to determine the criterion validity of the new classification of the     pattern of gait in children with spastic diplegia by correlating pattern of diplegic gait     with the score of the Functional performance measure.   "
252350|NCT01158846|"     In the setting of ST elevation myocardial infarction newer therapies has been recently     studied and, following encouraging results, introduced into the clinical practice. Prasugrel     showed to be a valid alternative to overcome limitation of clopidogrel therefore providing a     better ischemic protection. On the other hand, bivalirudin is at least as beneficial as     heparin/abciximab as anticoagulant agent but associated with fewer hemorrhagic events. The     primary hypothesis of the study is that the combination of prasugrel plus bivalirudin can be     associated with a better risk/benefit profile.   "
252354|NCT01158911|"     Patients in the earlier stages of Chronic kidney disease (CKD) are at risk both for the     development of end-stage renal disease (ESRD) (define by the requirement for dialysis or     kidney transplantation) and development of cardiovascular disease (CVD). Although     controversial, there is literature to suggest that uric acid may play a role in the     progression of kidney disease and development of cardiovascular disease (CVD). The     Modification of Diet in Renal Disease (MDRD) Study was a randomized controlled trial in     patients with CKD, which examined the effects of dietary protein restriction and strict blood     pressure control on progression of non-diabetic CKD. Extensive data on risk factors for     progression of kidney disease and development of CVD are available, as is long term follow     up. 838 of the 840 patients who were randomized have uric acid levels measured at baseline.     The aims of the present study are to examine the determinants of uric acid in cross sectional     analysis at baseline, to determine the association between uric acid and development of ESRD,     and the association of uric acid with all-cause and CVD mortality.      Level of kidney function will be a major determinant of uric acid levels independent of other     risk factors.      Level of uric acid will be associated with development of ESRD independent of level of kidney     function and other risk factors.      Uric Acid levels will be associated with both all-cause and CVD mortality independent of     kidney function and other risk factors.   "
252355|NCT01158924|"     Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5     in subjects with early lumbar disc degeneration.   "
252356|NCT01158937|"     Meropenem is an intravenous antibiotic commonly used to treat acute exacerbation of     respiratory infections in cystic fibrosis. The research study aims to determine if a     different method of infusing the drug over 3 hours or longer, instead of the traditional     half-hour will improve target attainment of drug concentrations and bactericidal activity. A     secondary aim is to assess if the pharmacokinetics of meropenem is different during active     infection compared to non-infective stage. Twelve patients admitted with acute respiratory     infection and who requires meropenem will be enrolled into the study. Meropenem blood     concentrations collected over 8 hours will be measured after half-hour and 3-hour infusions     on different days. A pharmacokinetic modelling and Monte Carlo simulation program will use     the data to assess and predict the optimal method of dosing. When patients return for a     follow-up clinic visit, a single dose of meropenem will be administered and blood     concentrations will be measured to determine the pharmacokinetics during non-infective stage.   "
252385|NCT01159327|"     A Phase I trial of weekly topotecan in combination with sorafenib in treatment of relapsed     Small cell lung cancer (SCLC) has been commenced. In the present randomized phase 2 study,     the investigators will research whether Sorafenib maintenance prolongs progression free     survival (PFS) and overall survival (OS) in patients with ED-SCLC who achieved CR or PR after     platinum-based induction chemotherapy.   "
252357|NCT01158950|"     In this study, we seek to understand the effects of tolcapone and entacapone, FDA-approved     COMT inhibitors, on reward choice and response inhibition, two measures we have previously     shown to be altered in subjects with alcoholism. We now plan to test the hypothesis that COMT     regulation of cortical dopamine levels is critical for regulation financial choices.     Specifically, we propose that the lower levels of cortical dopamine present in individuals     with the val158val COMT genotype reduces the inhibitory effect of frontal cortical areas on     impulsive choice; an idea that extends previous hypotheses about the negative consequences of     decreased prefrontal dopamine levels on inhibitory control. Moreover, this hypothesis     suggests that inhibiting COMT may slow the degradation of dopamine and thereby decrease     impulsivity.   "
252358|NCT01158976|"     This will be the first study of the effect of essential fatty acid supplementation in     pregnant women living in inner-city poverty on the stress response system during pregnancy.     The investigators proposed that essential fatty acid supplementation will be associated with     reductions in the experience of stress, more modulated hormonal response to stress, and more     optimal regulation of emotion and attention in the infant, even within the context inner-city     poverty.   "
252359|NCT01158989|"     The purpose of this study is to evaluate the clinical usefulness of a video camera pill     (PillCam) in assessing intestinal function in the small intestines of patients. It is     believed that the condition of the subjects digestive system can have a large impact on their     overall physical health. Therefore, the investigators would like to assess whether using the     pill device helps to determine any functional problems in patients in the ICU. The     investigators are studying ICU patients because any change in their condition can have a     large impact on their recovery. The same device will be used in healthy subjects scheduled     for elective ambulatory surgery.   "
252360|NCT01159002|"     The purpose of this study is to evaluate the clinical usefulness of a capsule (SmartPill~)     measuring pH, pressure and temperature from within the entire GI tract to determine gastric     emptying time, combined small and large bowel transit time and total transit time. In     addition, the Capsule will characterize pressure patterns and provide motility indices for     the antrum and duodenum. It is believed that the condition of your digestive system can have     a large impact on your overall physical health. Therefore,the investigators would like to     assess whether using the pill device helps to determine any functional problems in patients     in the ICU. The investigators are studying ICU patients because any change in their condition     can have a large impact on their recovery.   "
252361|NCT01159015|"     This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in     healthy adult subjects and in pediatric subjects with a history or family history of ocular     allergy.   "
252362|NCT01159028|"     The first goal of this clinical research study is to find the highest safe dose of BP1001, a     liposomal Growth Factor Receptor Bound Protein-2 antisense oligodeoxynucleotide (L-Grb2 AS),     for patients with Philadelphia Chromosome positive CML, AML, ALL and MDS. The response of the     leukemia to this treatment will also be studied. The second goal of this clinical research     study is to evaluate the safety and toxicity of the combination of BP1001 and concurrent     low-dose ara-C (LDAC) in patients with AML.   "
252363|NCT01159041|"     This study is designed to compare two treatments for depression in pre-adolescent (7-13 year     old) children. A family-focused treatment will be compared to an individual child-focused     treatment in this 14-week intervention.   "
252432|NCT01159938|"     This Study is looking at whether high blood glucose levels after a meal affect arterial     stiffness more or less than low blood glucose levels, and whether certain cardiovascular     markers influence the outcome of this.   "
252365|NCT01159067|"     RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have     undergone hematopoietic stem cell transplant and have iron overload.      PURPOSE: This pilot clinical trial studies safety and tolerability of deferasirox in     hematopoietic stem cell transplant recipients who have iron overload. Effect of low dose     deferasirox on labile plasma iron is also examined.   "
252366|NCT01159080|"     To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with     mycophenolate sodium dose increment will preserve renal allograft function without rising     adverse effects      Primary endpoints:        1. estimated GFR (MDRD equation) 12 months after randomization        2. estimated GFR change from randomization to end of the study (calculated by MDRD equation          and Nankivell equation)   "
252367|NCT01159093|"     This study will test the effectiveness of clinician-focused health IT-based decision support,     family-focused health IT-based decision support, and a combination of both efforts, in     increasing HPV and other adolescent vaccine rates among adolescent girls. We hypothesize that     a combination of clinician-focused clinical decision support and family-focused decision     support will be most effective.   "
252368|NCT01159106|"     The aim of the current study is to compare the application neurally adjusted ventilatory     assist (NAVA) to optimize pressure support ventilation in 12 pediatric patients.   "
252369|NCT01159119|"     The purpose of this study is to evaluate two different treatments in subjects with chronic     pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.   "
252370|NCT01159132|"     The purpose of this study is to study and compare the pharmacokinetics profile of low dose     raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected     patients.   "
252371|NCT01159145|"     The purpose of this study is to assess the pharmacodynamics (intragastric pH) after repeated     oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects who     are classified by the genotype of CYP2C19 by the assessment of percentage of time with     intragastric pH>4 during 24 hours after dose on day 5.   "
252372|NCT01159158|"     The objective of this study is to compare the rate and extent of absorption of nateglinide     120 mg tablet (test) versus Starlix ® (reference), administered as 1 x 120 mg tablet under     fasting conditions.   "
252442|NCT01160081|"     The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV),     Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella     pertussis (BP)infections in Mexico.   "
252374|NCT01159184|"     The increasing prevalence of diabetes brought great burden to health status of the     investigators population. It is meaningful to investigate the stressor, stress perceived,     social support and coping methods in diabetic population in order to provide appropriate     assistance to these patients. This study will recruit diabetes patients from     out-patient-department and they are invited to complete a questionnaire. The contents of the     questionnaire including stress experienced, stress perceived, social support and coping     methods. The investigators purpose is to find out the impact of these factors on glycemic     controlled and their life quality. The results will be useful to diabetes care team when     health education is delivered to patient.   "
252375|NCT01159197|"     Background      More than 50% of dialysis patients experience sleep disturbances that significantly affect     quality of life, overall morbidity, and mortality. There is no effective therapy except     hypnotics, which have notable side effects. Cognitive-behavioral therapy (CBT) is effective     for treating peritoneal dialysis (PD) patients, the elderly and cancer patients with chronic     insomnia, but its effectiveness has never been reported in hemodialysis (HD) patients and its     impacts on the inflammatory cytokines, oxidative stress and autonomic dysfunction in this     population are unknown. The investigators investigated the effectiveness of CBT in HD     patients by assessing changes in sleep quality, inflammatory cytokines, oxidative stress and     autonomic dysfunction.      Objects      This study is designed to assess the effectiveness of CBT on sleep disturbance in insomnias     HD patients. The investigators also evaluate the impacts of CBT on the inflammatory     cytokines, oxidative stress and autonomic dysfunction in these insomnias HD patients.      Methods      The investigators expected to recruit 80 insomnias HD patients undergoing maintenance HD for     more than 3 months for the investigation. Besides, 40 HD patients without sleep disturbance     will be recruited for comparison. Patients with sleep disturbance (N=80) was randomized to     either intervention (CBT) group (N=40) or control group (N=40). Participants in CBT group     will receive 6-week CBT while in control group and patients without sleep disturbance only     receive sleep hygiene education. The subjects were assessed at baseline and after the     intervention with the Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS),     Beck depression index (BDI) and the International Index of Erectile Function (IIEF) for men     and the Index of Female Sexual Function (IFSF) for women; and inflammatory cytokines (serum     IL-1β, IL-18, and TNF-α levels), oxidative stress (TBARS, Total antioxidant status and serum     8-OHdG) and autonomic dysfunction (Baroreflex sensitivity, BRS) were measured.      Expected results      The investigators expect that CBT can improve the sleep disturbance in HD patients and may     change the inflammatory cytokines, oxidative stress and autonomic dysfunction after the     intervention in insomnias HD patients.   "
252376|NCT01159210|"     The purpose of the study is to assess the efficacy and safety of Prothromplex Total as a     treatment for the immediate reversal of oral anticoagulant therapy with vitamin K antagonists     in patients with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX,     X). Upon enrolment, subjects will receive Prothromplex Total for the treatment of acute     bleeding due to oral anticoagulants or for the prevention of excessive bleeding during the     interventional procedure (Day 1). Additional doses of Prothromplex Total may be administered     at the discretion of the investigator. Efficacy and safety assessments will be performed     during a period of 72 (± 4) hours after administration of the last dose of Prothromplex Total     or until discharge from hospital, whichever occurs first.   "
252377|NCT01159223|"     This study will compare the efficacy and safety of ATV/r at either 200/100 mg or 300/100mg     given daily in Thai patients in combination with 2NRTIs.   "
252378|NCT01159236|"     The goal of this clinical research study is to learn if using gene signatures can be an     effective way to decide the best treatment for breast cancer patients. Gene signatures may be     able to help researchers predict who will respond to chemotherapy given before surgery.   "
252379|NCT01159249|"     This study is designed to demonstrate the long-term safety of vildagliptin in patients with     type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin,     thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the     treatment of type 2 diabetes in Japan.   "
252380|NCT01159262|"     The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of     dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks     gestational age, administered as a loading dose followed by a continuous infusion for a     minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac     intensive care unit (CICU), or pediatric intensive care unit (PICU).   "
252381|NCT01159275|"     The purpose of this study is to study the pharmacokinetics profiles of generic     lopinavir/ritonavir and Pediatric Aluvia® at reduced dose by assessing safety, tolerability     and efficacy.   "
252382|NCT01159288|"     Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases     per year, lung cancer is the 4th in terms of incidence but remains the leading cause of     cancer death. The 5-year survival of lung cancer, all stages and all types, is very low,     estimated at 12% among men and 16% among women in France. In advanced unresectable non small     cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The     median progression-free survival (PFS) in patients responding or stabilized after 4     chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have     developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by     vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits     Treg functions restoring T and NK cell effector functions and Dex are able to activate the     innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex     vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated     a new process for isolation of second generation Dex with improved immune stimulatory     capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients     responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS     rate at 4 months in these patients.   "
252383|NCT01159301|"     This phase I trial is studying the side effects and the best dose of entinostat when given     together with sorafenib tosylate in treating patients with advanced or metastatic solid     tumors or refractory or relapsed acute myeloid leukemia. Entinostat and sorafenib tosylate     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
252384|NCT01159314|"     This research is being done to compare the safety and effectiveness of two sizes of the     Baerveldt glaucoma implant.      A Baerveldt glaucoma implant is one of the most common types of glaucoma operations     performed. This procedure works by providing a route by which fluid can drain out of the eye     to decrease the intraocular pressure. The Baerveldt implant does this by placing a tube into     the eye which shunts aqueous fluid to a silicone plate which is attached to the sclera (white     portion of the eye). It is this plate that comes in two different sizes (250 square     millimeters and 350 square millimeters).      Earlier studies have shown that larger plate sizes produce lower eye pressures but that they     may also result in more complications. While both Baerveldt devices are currently in use and     have been shown to be safe and effective, it is unclear if one is superior to the other. The     purpose of this study is to see if one size of device works better with fewer complications.   "
252386|NCT01159340|"     The clinical performance of Icare ONE Tonometer TA02 was compared to a Goldmann type     applanation tonometer (Haag-Streit). Data was collected according to ANSI Z80.10-2003 (ISO     8612.2) standard. Subjects were eligible for the study if they had no exclusion criteria     specified in the ANSI/ISO standard. One eye from 260 subjects was selected for the study. The     minimum sample size according to the standard is 150. One eye of each subject was selected     for the study by an investigator, based on the history of the patient, results of an external     examination of the eye with slit lamp, keratometry readings, and prior knowledge of the     intraocular pressure (IOP) range. The Icare ONE Tonometer TA02 in comparison to the reference     tonometer (Goldmann type tonometer).   "
252387|NCT01159353|"     Primary Objective:        -  To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion          during the first hour after a standard meal in comparison to insulin aspart in obese          subjects with type 2 diabetes.      Secondary Objectives:      Pharmacodynamic objectives:        -  To assess the effect of insulin glulisine on the postprandial plasma glucose excursion          during 6 hours after a standard meal in comparison to insulin aspart.      Pharmacokinetic objective:        -  To assess post-prandial plasma insulin excursion after a standard meal, in each          treatment groups      Safety objective:        -  To assess the safety of insulin glulisine in comparison to insulin aspart   "
252388|NCT01159366|"     It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an     infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography     frequently elude standard 12-lead electrocardiogram diagnosis. In addition, coronary     collaterals may have beneficial effects in patients with OCA.   "
252389|NCT01159379|"     The purpose of this study is to assess cross-reactivity and tolerability of ertapenem in     patients with IgE-mediated allergy to at least one beta-lactam molecule.   "
252390|NCT01159392|"     Development of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in     patients with severe brain injury has been associated with poor outcome. The application of     lung recruitment maneuvers (RM) for a short period of time to open collapsed alveoli and     reverse hypoxemia in early ARDS has been recommended. However, little is known about the     cerebral and vascular effects of RM in brain injury patients with ALI/ARDS. The aim of this     study is to assess the effects of a single standardized RM on oxygenation and on systemic and     cerebral hemodynamics in severe brain injury patients with ALI/ARDS.   "
252391|NCT01159405|"     The purpose of this study is to evaluate the biodistribution and dosimetry of single dose of     99mTc-glycopeptide (99mTc-GP, 20-25 mCi) in 3 different doses of GP (5, 10and 20 mg)in     patients with breast cancer at pre-chemotherapy.   "
252392|NCT01159418|"     The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of Panobinostat     (LBH589) when administered in combination with Carboplatin and Paclitaxel in patients with     advanced solid malignancies and to identify the Recommended Dose (RD) for a subsequent Phase     II study.   "
252393|NCT01159431|"     This study investigates a new therapy for epilepsy called Trigeminal Nerve Stimulation (TNS).     TNS involves external electrical stimulation of sensory nerve located above the eyes and over     the forehead. The purpose of this study is to determine if TNS is safe and effective using a     rigorous randomized active-control clinical trial design in 50 people with epilepsy.   "
252394|NCT01159444|"     Home bi-level positive pressure ventilators are equipped with built-in softwares which     measure and record specific items such as tidal volume, total ventilation, leaks, respiratory     rate, cycles triggered by the patient. These items have not to date been described in a large     group of patients under home mechanical ventilation.   "
252433|NCT01159951|"     The purpose of this study is to analyze the incidence of baseline hepatitis related outcomes     (viral hepatitis A and unspecified viral hepatitis) together with the current frequency of     the same outcome after introduction of Havrix™ in Panama.   "
252395|NCT01159457|"     Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and     carry a high morbidity rate. It has been recently shown that patients with celiac disease     very often fail to develop immunity after standard vaccination for HBV during infancy. In     this study, we will evaluate whether a second vaccination series with a different vaccine,     Sci-B-Vac, results in a better immunological response in celiac patients. Eligible patients     will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac     vaccines.. Rate of responders and level of immunity will be compared. This study will     facilitate better protection of celiac patients to this potentially deadly virus.   "
252396|NCT01159470|"     Fever is one of the most common problems in pediatrics. Differentiating between bacterial     infections, that require antibiotic therapy, and viral infections that resolve on their own     is an important challenge for physicians.      C-reactive protein (CRP) is a protein that increases in response to inflammation and its     level is generally higher in bacterial infections compared to viral infections. it can be     measured by a simple blood test, however its utility as a sole marker for bacterial infection     is limited.      The hypothesis of the study is that measuring CRP velocity, e.g the value of CRP divided by     the hours since the fever started will improve the utility of CRP for the diagnosis of     bacterial infections in children.   "
252397|NCT01159483|"     PF-04958242 in single doses will be safe and well tolerated by healthy volunteers.   "
252398|NCT01159496|"     This is a multiple ascending dose study to assess the safety, tolerability and     pharmacokinetics of PF-05212377 (SAM-760) administered orally once a day for 14 days to     healthy young adults and healthy elderly subjects. The study will be conducted under     double-blind conditions (neither the investigator nor the subject will know if he/she has     received PF-05212377 or a placebo). The Sponsor will know if the subject has received active     treatment or a placebo.   "
252399|NCT01159509|"     The loss of sodium during infancy causes long term changes in sodium intake. Human research     shows that the loss of maternal sodium during pregnancy and neonatal after birth causes an     increase sodium intake during childhood. A study that examined sodium intake among infants     that were treated with diuretics during the post-natal period found changes in sodium intake     compared to controls. In this study we will test sodium intake in young children who have     suffered from vomiting due to Hypertrophic Pyloric stenosis during early infancy.   "
252400|NCT01159522|"     The goal of this study with SCB01A is to determine the Maximum Tolerated Dose of SCB01A in     patients with advanced solid tumors that have failed previous therapy.   "
252505|NCT01160588|"     This study will attempt to identify gene and brain activity markers that predict whether     children and adolescents with anxiety disorders will respond to selective serotonin reuptake     inhibitor medications or Cognitive Behavioral Therapy (CBT).   "
252401|NCT01159535|"     The broad, long-term objective of the proposed randomized clinical trial is to evaluate the     efficacy, moderators and mechanisms of change of two cognitive-behavioral aftercare     treatments for alcohol and other drug (AOD) use disorders in preventing AOD relapse compared     to treatment as usual (TAU) offered in the community. The two cognitive-behavioral aftercare     treatments are relapse prevention (RP) and Mindfulness-Based Relapse Prevention (MBRP), which     integrates mindfulness meditation and RP aftercare components.   "
252402|NCT01159548|"     There has been an increase in ambulatory surgical procedures performed across Canada;     ambulatory procedures account for almost 70% of all surgeries. Postoperative nausea and     vomiting (PONV) and pain are the most frequently reported adverse events by patients prior to     discharge after ambulatory surgery. The incidence can be as high as 70 to 80% in high-risk     patients.      PONV is a cause of morbidity particularly in gynecological procedures and the incidence of     patients experiencing PONV is as high as 58-75%. Apart from delayed recovery, the occurrence     of PONV has been linked to gastric aspiration, psychological distress and wound dehiscence.     The occurrence of PONV delays patient discharge and further more is a leading cause of     unexpected admission after ambulatory anesthesia      Promethazine, is an antiemetic medication that has been widely used over the last 50 years,     and although effective at reducing PONV, it tends to cause sedation. In this study, we are     trying to determine if a smaller dose of promethazine, in addition to the standard treatment     for post-surgical nausea and vomiting, will be more beneficial than the standard treatment on     its own.      It is hypothesized that the use of low dose promethazine (3 mg) as part of a multimodal     antiemetic regimen will be efficacious in preventing PONV without the sedative effects of     promethazine.   "
252403|NCT01159561|"     This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number     3-1-92.   "
252404|NCT01159574|"     This study is intended to investigate the combination of the combination of dexamethasone     (Decadron®), Clarithromycin (Biaxin®), and pomalidomide (CC-4047®) [ClaPd] in multiple     myeloma patients who have relapsed or refractory disease who have failed prior treatment with     lenalidomide when used alone or in combination with corticosteroids. Primary endpoint will be     response rate to treatment. Secondary endpoints will include toxicity of the combination,     time to maximum response, and time to disease progression   "
252405|NCT01159587|"     The project is a controlled observational, multicenter, prospective data collection on     secondary prophylaxis with Kogenate Bayer in adolescents and adults with severe haemophilia A     (FVIII < 1%).      The observational period will cover at least 5 years per patient.      The long-term secondary prophylaxis group will be compared versus on-demand treatment group     by the assessment of orthopedic status progression and pharmacoeconomics evaluation.   "
252406|NCT01159600|"     The objective of the current study is to investigate the efficacy, safety and tolerability of     two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin     or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient     glycaemic control.   "
252407|NCT01159613|"     The working hypothesis is that the low HDL serum level predict favorable response to anti     viral treatment in chronic HCV (genotype 1) viral infection. This might be used to improve     the rate of sustained virologic response.   "
252408|NCT01159626|"     This Phase 1 study is the first clinical trial in Japanese subjects. The study is designed to     evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of     PF-03463275 oral controlled release formulation in Japanese and Western male subjects.   "
252409|NCT01159639|"     Reactive platelet hyperactivity following coronary artery bypass grafting (CABG) might lead     to thrombotic complications and major ischemic cardiac events. The aim of this study is to     evaluate the changes in platelet reactivity following CABG and to clarify a potentially     beneficial effect of dual antiplatelet therapy in the group of patients with documented     aspirin resistance following CABG. Platelet function will be assessed by multiple electrode     aggregometry. Aortocoronary vein graft disease is comprised of three distinct but     interrelated pathological processes: thrombosis, intimal hyperplasia and atherosclerosis.     Early vein thrombosis is a major cause of vein graft attrition during the first month after     CABG.      Bypass patency can be improved with antiplatelet therapy which is the mainstay of treatment     for patients after CABG. A beneficial effect of acetylsalicylic acid (ASA) on vein graft     patency has been previously shown. Some patients experience thrombotic events despite     continuous aspirin administration after CABG. The investigators hypothesized that low     responsiveness to aspirin might be a precipitating factor for adverse thrombotic events     following CABG.      Low responsiveness to ASA, as assessed by platelet function tests, varies widely among     patients. The etiology of postoperative platelet hyperactivity remains to be elucidated.      In this study a new point-of-care assay named multiple electrode aggregometry (MEA) using a     device called Multiplate analyzer (Dynabyte, Munich, Germany) has been utilized. It allows     for rapid and standardized assessment of platelet function parameters.      This is a prospective randomized trial. The aim of the study is to document whether     introduction of dual antiplatelet therapy in patients with ASA resistance will lead to a     lower incidence of major adverse cardiac events (MACE) at a six month follow up. The     composite endpoint will include death, non-fatal myocardial infarction, stroke and cardiac     rehospitalization. All patients will receive 300 mg of ASA starting 6 hours after surgery,     provided that the chest tube output is minimal. On postoperative day 4 their platelet     function will be assessed using the above mentioned MEA. The patients found to be aspirin     resistant will then undergo the process of randomization. The first arm will include patients     with ASA resistance in whom no additional antiaggregation will be administered. In the second     arm the investigators will include patients who were randomized to receive 75 mg of     clopidogrel in addition to the standard antiplatelet regimen of 300 mg of ASA.      Platelet function monitoring allows for individual tailoring of the antiplatelet therapy. The     goal of this study is to define whether this strategy will lead to improved patient outcomes.     Both major and minor bleeding complications will be strictly monitored and reported.   "
252410|NCT01159652|"     The purpose of this study is to determine the effect of two hypnotic medications, zolpidem     extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug     duration will allow greater memory consolidation than a hypnotic with longer drug duration.   "
252411|NCT01159665|"     To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when     administered at different time-points prior to planned primary pars plana vitrectomy (PPV)   "
252412|NCT01159678|"     The purpose of this study is to test an online psychoeducational intervention for men and     women with sexual difficulties after surgery for colorectal (men and women) or gynecological     (women only) cancer. A psychoeducational intervention is a brief, educational treatment that     encourages participants to also pay attention to, and modify, their thoughts, feelings, and     behaviour.   "
252413|NCT01159691|"     The study intends to collect data on gastrointestinal symptoms (swallowing disorders,     heartburn, feeling of fullness, nausea, vomiting, abdominal pain, diarrhea) and on patient     satisfaction under everyday practice conditions after changing treatment to Neupro®     transdermal patch in patients suffering from idiopathic Parkinson´s Disease with     gastrointestinal symptoms while being treated with oral antiparkinson drugs. The objective of     the study is to ascertain whether switching therapy to Neupro® transdermal patch can provide     any relief in gastrointestinal symptoms.   "
252414|NCT01159704|"     Using a randomized clinical trial (RCT), this study is designed to assess the effectiveness     of HIV (human immunodeficiency virus) risk-reduction interventions targeting injection drug     users (IDUs) in three Ukraine oblasts (regions). The investigators propose to compare the     effectiveness of a revised and updated manually-driven HIV testing and counseling     intervention, the Counseling and Education (C & E) model developed by NIDA, with the C & E     plus a manualized network intervention. At each site, Odessa, Donetsk and Nikolayev, 250     index members and 500 of their network members will be recruited through street outreach     over a 32-month period and randomly assigned to C & E alone or C & E plus the network     intervention. Participants will be tested for drug metabolites, interviewed using ACASI     (Audio Computer-Assisted Self-Interviewing), and given a rapid test for HIV at baseline, 6     and 12-months. At six-months, network members will be asked to recruit two others they inject     with but who are not in the study. Primary outcomes include knowledge, self-efficacy,     injection and sex-related risk behavior reduction and partner disclosure among indexes and     primary and secondary network members and intervention diffusion to secondary network     members. The investigators hypothesize more positive and significant change, including     injection and sex risk reduction, intervention diffusion, and partner disclosure, among     indexes as well as first and second network members in the network plus C & E arm compared to     C & E alone. Specific aims include:        1. To compare the effectiveness of the C & E alone with the additive effect of a network          intervention plus C & E in increasing knowledge about HIV and increasing self-efficacy          to practice safer injection and sex-related behaviors among indexes, primary and          secondary network members.        2. To assess the effectiveness of the C & E alone with the additive effect of a network          intervention plus C & E in reducing drug and sex risk behaviors among indexes, primary          and secondary network members.        3. To compare the extent of intervention diffusion to second wave network members in the          two arms.        4. To evaluate the extent of disclosure by HIV positive indexes and network members in the          two arms   "
252415|NCT01159717|"     Retrospective comparison of complex cystic renal lesions which are found with computed     tomography (CT) and were controlled with contrast enhanced ultrasound (CEUS).   "
252416|NCT01159730|"     The purpose of this study is to assess the safety and tolerability of multiple doses of     VB-201 administered for 4 weeks and its efficacy on biomarkers.   "
252417|NCT01159743|"     The purpose of this study is to compare the body fat distribution in Human Immunodeficiency     Virus-1 (HIV-1) infected patients receiving, since the beginning and for at least two years,     an antiretroviral therapy based on efavirenz or lopinavir/ritonavir and a combination of     tenofovir plus emtricitabine (or lamivudine).   "
252418|NCT01159756|"     This study is a multi-site, unmasked phase IV study. Travacom(R) is a combination topical     ocular agent, containing travoprost and timolol, which lower intraocular pressure (IOP) by     complementary mechanisms of action. The safety and efficacy of both travoprost and timolol     have been established as single and adjunctive therapy in well-controlled clinical studies in     thousands of patients diagnosed with open angle glaucoma (OAG) or ocular hypertension. The     objective of this study is to assess the safety and efficacy of changing to Travacom from     prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular     hypertension across India.   "
252419|NCT01159769|"     The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once     daily in patients previously treated with twice-daily, topical, ocular, anti-allergy     medications.   "
252434|NCT01159964|"     The purpose of this clinical study is to assess the safety and immunogenicity of the     immunotherapeutic product GSK 2302032A when given to Non-Small Cell Lung Cancer (NSCLC)     patients, after tumor removal by surgery.   "
252488|NCT01160354|"     The goal of Part 1 of this clinical research study is to learn about the safety of the     combination of plerixafor and clofarabine when given to patients with previously untreated     AML who are at least 60 years old.      The goal of Part 2 of this study is to learn if the combination of plerixafor and clofarabine     can help to control previously untreated AML in patients who are at least 60 years old.   "
252756|NCT01164735|"     This research study is studying biomarkers in tissue samples from patients with stage III,     stage IV, or recurrent endometrial cancer. Studying samples of tumor tissue from patients     with cancer in the laboratory may help doctors learn more about changes that occur in     deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.   "
252420|NCT01159782|"     We, the investigators, hypothesise that there are distinct gene profiles in     rhinovirus-induced acute exacerbations of asthma. We further hypothesise that these changes     in gene expression involve both known mediators of the asthma phenotype as well as other     molecules not previously associated with asthma.      The primary objective of this study is to use gene array analysis to determine differentially     expressed genes in bronchial epithelial cells and alveolar macrophages from normal and     asthmatic subjects before and during rhinovirus infection in vivo. A secondary objective is     to determine whether any altered expressions are related to symptom severity, virus load,     lung function or airway inflammation in vivo.      We plan to recruit 45 subjects: 15 healthy volunteers, 15 asthmatics naïve to inhaled     corticosteroid therapy, and 15 asthmatics on inhaled corticosteroids who will undergo two     bronchoscopies, one prior to infection with rhinovirus and the second 4 days post     inoculation. Bronchial brushings, biopsies and bronchoalveolar lavage (BAL) will be     performed. RNA will be extracted with TRIzol reagent (Invitrogen, Carlsbad, CA) and purified     by passage through RNeasy columns (Qiagen, Valencia, CA). Exon 1.0ST array chips (Affymetrix,     Santa Clara, CA) will be used to analyse changes in gene expression. These are the most     powerful genome expression tools available with 1.4 million probe sets and over 5.5 million     features per array. Genes found to be significantly upregulated will be confirmed by     quantitative RT-PCR.      Using a novel method of collecting undiluted bronchial epithelial lining fluid     (bronchosorption) large numbers of proteins will be measured with a MesoScale Discovery     multiplexed array system (MesoScale Discovery, Gaithersburg, Md) allowing further     confirmation of the gene array results as well as providing in vivo evidence of dysregulated     protein production in asthmatics. Gene expression and protein levels will be correlated with     viral load, symptom scores, lung function and airway inflammation in vivo.      This study represents the first comprehensive evaluation of changes in bronchial epithelial     gene expression during rhinovirus infection in vivo and therefore has the potential to     provide significant insights into the host response in asthma and identify potential novel     targets for further evaluation.   "
252421|NCT01159795|"     This study aims to establish whether impaired innate immune responses are associated with     severity of Respiratory syncytial virus (RSV) infection.   "
252422|NCT01159808|"     The purpose of this study is to test the safety of different dose strengths of INX-08189 in     healthy adults. The study will also look at how rapidly the drug breaks down in the body     (pharmacokinetics or PK). The study objectives include:        -  To evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects        -  To characterize the pharmacokinetic (PK) profile of single ascending oral doses of          INX-08189 in healthy subjects        -  To assess the food effect on the PK of a single oral dose of INX-08189   "
252423|NCT01159821|"     The purpose of this study is to determine the concentration of 31001074 in blood samples from     healthy volunteers who have been administered 31001074 and paroxetine.   "
252424|NCT01159834|"     PROJECT JUSTIFICATION: Cervical cancer is a serious public health problem in Brazil, and is     the cause of significant morbidity and mortality among Brazilian women. In spite of     government efforts to improve the coverage rates of Pap tests, the disease-related incidence     and mortality rates remain high and the diagnosis is still too late.Considering that the     chronic human papillomavirus (HPV) related genital infection leads to cervical cancer     development, cervical cancer should be the target of primary prevention through vaccination.      PROJECT OBJECTIVES: This project aims to evaluate de following vaccination indicators: 1)     Program acceptance rate; 2) Vaccine coverage rate; 3) Three-dose completion rate; 4) Rescue     vaccination demand; 5) Adverse event rate;      TARGET POPULATION: Schoolgirls attending the 6th and 7th grades of elementary school (mean     age = 11.9 yo).      VACCINATION PROGRAM: The program adopted the quadrivalent vaccine because it is considered     superior to the bivalent vaccine in preventing HPV-induced lesions. In addition to preventing     the development of pre-cancer lesions and cervical cancer, the quadrivalent vaccine has also     proved to be effective in preventing condyloma, and vaginal and vulvar cancer. The girls     received the vaccines doses at their schools (school-based program) and also at the Barretos     Cancer Hospital.      RESULTS:      Program acceptance rate = 91.8% (95%CI: 87.0%-96.8%);      Vaccine coverage for 1st, 2nd and 3rd doses = 87.5% (95%CI: 82.9%-92.2%), 86.3% (95%CI:     81.8%-91.1%) and 85.0% (95%CI: 80.5%-89.7%).      Three dose completion rate = 97.2% (95%CI: 92.0%-100.0%). Reasons for dropping out of the     vaccination program included: moving out of town (17), lost during follow up (16), guardians'     decision but without a reasonable justification (3), girl refused to continue in the program     (1) and pregnancy (2). Two girls interrupted the vaccination because of adverse events     reported by the parents.      Rescue vaccination demand = 279 girls on the first dose (20.3%; 95%CI: 17.9%-22.8%), 357 on     the second dose (26.3%; 95%CI=23.6%-29.1%) and 291 on the third dose (21.7%;     95%CI=19.3%-24.4%).      Thirty adverse events were recorded or observed in 4,074 doses, providing an adverse event     rate of 0.7% (95%CI: 0.5%-1.1%). There was no severe adverse event.   "
252425|NCT01159847|"     The aim of this study is to investigate the protective effects of sitagliptin on β cell     function in patients with adult-onset latent autoimmune diabetes (LADA) and its mechanisms.   "
252426|NCT01159860|"     Seborrheic keratoses (SK's) are very common, but harmless skin lesions that commonly appear     during adult life. Patients with seborrheic keratoses frequently desire treatment due to     symptoms of itching and irritation or for cosmetic purposes. Seborrheic keratoses can be     easily removed and have been treated in a number of different ways. Two of the simplest and     most successful ways to remove seborrheic keratoses are cryosurgery and curettage.      The investigators are conducting this study to see which of these two treatments has the best     result.      Approximately 24-30 people will take part in this research study at the Hershey Medical     Center.   "
252427|NCT01159873|"     Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in     Healthy Postmenopausal Women.   "
252428|NCT01159886|"     During colonoscopy, the colonoscopist employs various maneuvers, including changing the     patient's posture to left-lateral decubitus or supine, to achieve complete colonoscopic     examination. Posture change has also been reported to increase the success rate of ileal     intubation. However, there has been no randomized trial which has shown that a particular     posture of the patient increases the success rate of ileoscopy. The present study will be     carried out to determine the impact of the patient's posture (left lateral vs supine     position) on success rate of ileal intubation.   "
252429|NCT01159899|"     The purpose of this pilot study is to investigate the efficacy and safety of autologous     transplantation, under arthroscopy, of Bone Marrow Mesenchymal stem cells, using, with a cell     separator, a fresh non-culture expanded Autologous Bone Marrow derived Mesenchymal Stem,     mixed and activated with proteins scaffold in patient with Knee cartilage defects and     osteoarthritis. Based on extensive preclinical investigations, the technology of using     freshly isolated bone marrow mononuclear cells mixed with proteins seems safe and most     effective for a one-step correction of cartilage defect and restoration of the osteochondral     complex, because the same mixture can generate cartilage in the vasculature-free knee joint,     and bone in the environment of bone defects.   "
252430|NCT01159912|"     A randomised, double-blind, double-dummy, placebo controlled (with rescue medication),     multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation     powder in the treatment of persistent asthma in adults and adolescents.   "
252431|NCT01159925|"     The purpose of this study is to collect epidemiological and clinical data to assess the     vaccine impact and occurrence of confirmed acute hepatitis A cases in sentinel hospitals     after the introduction of Havrix™ into the Expanded Program of Immunization.   "
252475|NCT01154621|"     The aim of this study is to examine the safety and tolerability of a single dose of AZD9742     in elderly individuals.   "
252435|NCT01159977|"     The study purpose is to evaluate the effect of a small group discussion based intervention on     physician well-being, job satisfaction, and professionalism. Participants will be put in one     of 3 groups by chance (as in the flip of a coin). A computerized selection process will be     used to assign participants to the study groups. There is a 1 in 3 chance of being assigned     at random to either of the 3 groups.      The first study group will meet once every two weeks for 9 months (from September 2010     through June 2011) from 12:30 pm until 2:00 pm. These meetings will be small group discussion     sessions with groups of no more than 15 participants. Lunch will be provided for the first 30     minutes, and group discussion during the next 1 hour will be guided by the session     facilitator around such topics as work-life balance, meaning in work, medical mistakes,     spirituality, and unmet patient needs. However, the discussions will be open forums, and the     groups themselves will help decide on topics relevant to the group. The 1 hour of protected     non-clinical time every other week required for this group will be funded by the study.      The second study group will also have 1 hour of protected non-clinical time provided every     other week for the same 9 months. This study group will not participate in small group     discussions, but may use the protected time for professional tasks as they wish.      Participants in the third study group will continue with their current work practices, but     will be provided with protected time to complete study surveys. If group sizes are too small     after recruitment to allow a complete study of all three groups, the third study group will     be removed and participants will be randomly assigned to one of the first two study groups     only.      Participants in all groups will be asked to complete a quarterly survey on well-being, job     satisfaction, and professionalism. Follow-up surveys will also be administered 3 months and 1     year after the conclusion of the small group sessions. Each survey is expected to take     approximately 20-30 minutes to complete.   "
252436|NCT01159990|"     HIV vaccines are designed to create an immune response to certain components of the HIV virus     called peptides. Previous research indicates that one peptide, called Gag, may be     particularly important for stimulating an immune response to HIV. Many vaccines being studied     combine multiple peptides, but including other peptides may weaken the body's response to     Gag. This study will test whether a vaccine that targets Gag and another peptide called Env     is better than a vaccine without Env at causing an immune response to Gag.   "
252437|NCT01160003|"     This study is a randomised, double-blind, placebo-controlled, dose ascending, 3-way crossover     study in healthy adult male volunteers. The primary objective of the study is to assess the     pharmacokinetics of 14 days dosing of GW870086X administered via nebules formulation. The     secondary objective is to assess the safety and tolerability of repeat doses of nebulised     GW870086X.   "
252438|NCT01160029|"     The objective of this study is to compare the rate and extent of absorption of nateglinide     120 mg tablet (test) versus Starlix ® (reference), administered as 1 x 120 mg tablet under     fed conditions.   "
252439|NCT01160042|"     The objectives of this study are:      To compare the single dose bioavailability of Metformin Hydrochloride 1000 mg tablets (Dr.     Reddy's Laboratories Ltd., Generics, India) with Glucophage (Metformin Hydrochloride) 1000 mg     tablets (Bristol-Myers Squibb, USA) in 52 + (2 standby) healthy, adult, human subjects under     fasting conditions.      To monitor adverse events and to ensure the safety of subjects.   "
252440|NCT01160055|"     The purpose of this epidemiological study is to identify and characterize the bacteria     causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt.   "
252441|NCT01160068|"     To compare the single dose bioavailability of Metformin Hydrochloride 1000 mg tablets (Dr.     Reddy's Laboratories Ltd., Generics, India) with Glucophage (Metformin Hydrochloride) 1000 mg     tablets (Bristol-Myers Squibb, USA) in 48 + (2 standby) healthy, adult, human subjects under     fed conditions.      To monitor adverse events and to ensure the safety of subjects.   "
252443|NCT01160094|"     It will be conducted as an international multicenter prospective observational cohort study     in a population of ErbB2 positive metastatic breast cancer patients, whose disease has     progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1:     patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression     (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or     more lines of treatment after 1st trastuzumab progression (third line or greater).   "
252444|NCT01160107|"     This study will determine whether the association of Revlimid and Prednisone (RP) as     induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation     treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM     patients.   "
252445|NCT01160120|"     The purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and     efavirenz, and 144 weeks safety and efficacy of the generic fixed dose combination of     tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.   "
252446|NCT01160133|"     This is a multi-site, randomized, investigator-masked study to evaluate the physical effects     of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a     6-week, perspective, randomized, active-controlled, investigator-masked, parallel group     study.   "
252447|NCT01160146|"     Overweight and obesity has become an epidemic which warrants more aggressive treatment.     However, few primary care physicians (PCPs) address this issue or do not possess adequate     education regarding treatment modalities such as nutrition counseling or bariatric surgery.     The primary goal of this study will be to determine whether the referrals for weight     management can be influenced through obesity education.   "
252448|NCT01160159|"     Rationale: To analyse the arterial state of women with thrombophilia by techniques studying     micro and arterial macrocirculation because of a reported and still discussed increase risk     in cardio-vascular events in these women.      Primary objective: To measure endothelium dependent vasodilatation (VDE) in controls and in     women with thrombophilia.   "
252449|NCT01160172|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of     several formulations of an investigational Staphylococcal vaccine.   "
252450|NCT01160185|"     This meta-analysis was conducted to investigate the efficacy of Topotecan and other     treatments for recurrent and stage IVB carcinoma of the cervix   "
252476|NCT01154634|"     The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy     male subjects.   "
252489|NCT01160367|"     Specific Aims and Hypotheses:      Aim 1: To test the effect of the Trial of Ascertaining Individual preferences for Loved     Ones' Role in End-of-life Decisions (TAILORED) Intervention on family decision-making     self-efficacy at 8 weeks both with respect to the patient's present situation and in a     hypothetical situation in which the patient lacks decision-making capacity.      Hypotheses 1a: Family decision-making self-efficacy will be greater at 8 weeks in pairs that     have undergone the TAILORED Intervention than in pairs receiving the standard information on     advance directives in the patient's present situation.      Hypotheses 1b: Family decision-making self-efficacy will be greater at 8 weeks in pairs that     have undergone the TAILORED Intervention than in pairs receiving the standard information on     advance directives in the hypothetical situation in which the patient lacks decision making     capacity.      Aim 2: To test the effect of the TAILORED Intervention on family psychological outcomes     (depression, caregiver burden, decision making distress).      Hypotheses 2a: Depression will be less at 8 weeks in family members who have undergone the     TAILORED Intervention than in family members who have received the standard information on     advance directives.      Hypotheses 2b: Caregiver burden will be less at 8 weeks in family members who have undergone     the TAILORED Intervention than in family members who have received the standard information     on advance directives.      Hypotheses 2c: Decision-making distress will be less at 8 weeks in family members who have     undergone the TAILORED Intervention than in family members who have received the standard     information on advance directives.      Aim 3: To test the effect of the TAILORED Intervention on patient and family satisfaction     with family decision-making involvement.      Hypothesis 3a: Patient satisfaction with family decision involvement will be greater at 8     weeks in patients who have undergone the TAILORED Intervention than in patients receiving the     standard information on advance directives.      Hypothesis 3b: Family member satisfaction with decision involvement will be greater at 8     weeks in family members who have undergone the TAILORED Intervention than in family members     receiving the standard information on advance directives.      Aim 4: To explore family decision-making self-efficacy and perceptions of the TAILORED     Intervention.   "
252451|NCT01160198|"     Iron deficiency anaemia (Haemoglobin, Hb < 12gm/dl) is one of India's major public health     problems particularly in women. Effective control of iron deficiency anaemia decreases the     incidence of fatigue, bodyache, headache, lack of concentration and menstrual complications.     Iron bisglycine chelate has been used successfully to treat iron deficiency anaemia and is     also a well tolerated therapy. Use of ferrous bisglycinate chelate one tablet daily as a     nutritional supplement is well established in India. For treatment of iron deficiency     anaemia, some women may need 1 tablet/day, while some may need 2 tablets/day. In India,     ferrous ascorbate, 1 tablet daily is a widely accepted form of treatment for iron deficiency     anaemia. The primary purpose of this study is to demonstrate the efficacy and tolerability     profile of ferrous bisglycinate chelate to support the registration of this product as a     'drug' in India. Comparative data between ferrous bisglycinate chelate and ferrous ascorbate     will also augment our existing knowledge, which will further support appropriate use of     ferrous bisglycinate chelate for the treatment of iron deficiency anaemia. Study design and     patient population: This will be a multicentre, randomized, laboratory-blinded, parallel-     group study. It is projected that the study will randomize 270 women (90 subjects in each     treatment arm) with iron deficiency anaemia (Hb 6-9 gm/dl + serum Ferritin <15 μg/l) to     either ferrous bisglycinate chelate 1 or 2 tablets/day, or ferrous ascorbate 1 tablet/day for     8 weeks. At fortnightly visits, blood will be collected for Hb (to evaluate efficacy),     adverse events will be documented (to evaluate tolerability), the investigational drugs will     be dispensed and reasons for non compliance will be recorded. Study endpoints: The primary     endpoint is defined as the rise of Hb from baseline after 8 weeks of treatment in each     ferrous bisglycinate chelate group (1 tablet/day and 2 tablets/day). The secondary endpoints     include the difference in the average change in Hb, difference in the rate of rise of Hb,     difference in the proportion of patients who achieve a target Hb ≥12gm/dl and difference in     the % incidence of gastrointestinal side effects during 8 week therapy with 2 dosing regimens     of ferrous bisglycinate chelate (1 tablet/day and 2 tablets/day) and ferrous ascorbate 1     tablet/day.   "
252452|NCT01160211|"     A study to compare the safety and efficacy of an aromatase inhibitor in combination with     lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+     metastatic breast cancer (MBC).   "
252453|NCT01160224|"     GW766994 is a selective, competitive antagonist of the human CC chemokine receptor-3 (CCR3).     It is proposed that the inhibition of the CCR3 receptor may provide a treatment for airway     inflammation such as in asthma. This will be a double-blind, placebo controlled, parallel     group study being conducted to evaluate the effects of GW766994 in subjects with     mild-moderate asthma who have high sputum eosinophilia. The primary objective is to compare     the effects of GW766994 to placebo on sputum eosinophils.   "
252454|NCT01160237|"     The aim of this study is to evaluate the immune response and the safety of one injection of     FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM in subjects who had received a single     Pandemrix TM dose at least 6 months preceding study inclusion. Subjects never vaccinated with     any H1N1 pandemic vaccine will be enrolled as control.      This Protocol Posting has been updated following Amendment of the Protocol, July 2010. The     impacted section is entry criteria.   "
252455|NCT01160250|"     This is an open-label, non-comparative, multicenter, expanded access study of Vismodegib     (GDC-0449) in patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC     (mBCC) who are otherwise without satisfactory treatment options.   "
252456|NCT01160263|"     The purpose of this study is to study the transporters of serotonin and dopamine in ALS     patients in relation with the clinical phenotype, i.e., patients without stiffness, patients     with pyramidal stiffness, patients with mixed (pyramidal and extra pyramidal) stiffness.      For such a goal the investigators will use SPECT to compare the binding of two specific     tracers in ALS patients and in matched healthy controls.   "
252457|NCT01160276|"     Ciclosporin inhibits P-glycoprotein should increase colchicine bioavailability whereas     tacrolimus should not influence colchicine disposition.      This is a prospective, controlled, open labeled study performed in renal graft recipients     comparing colchicine single dose (1mg) pharmacokinetics in 14 patients treated with     tacrolimus and 14 patients treated with cyclosporin.   "
252458|NCT01160289|"     The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to     tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED)     who incompletely respond to tadalafil alone.   "
252459|NCT01160302|"     There is considerable evidence that turmeric consumption may have a protective effect against     cancer progression. The purpose of this study is to examine the short-term effects of     supplementation with a turmeric extract, Curcumin C3 Complex®, on biomarkers of head and neck     squamous cell carcinoma (HNSCC).   "
252460|NCT01160315|"     Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to     treat neoplastic and benign diseases. These drugs are definitely associated with premature     ovarian failure (POF), resulting in an important decrease of the long-term quality of life     and an increase of morbidity. A recent study showed that the patients treated by alkylating     agents had a 4.52 fold higher risk to lose their ovarian function compared with those who     were treated by other agents. The rate of POF after treatment ranged from 40 to 80%,     according to the age of the patients and the total doses administered.      Young women who experience POF have to face with the prospects of infertility and to consider     years of hormonal replacement therapy. The possibility of minimizing gonadal damage by     administering of protective therapy during chemotherapy represents an attractive option for     these patients.      The aim of this study is to evaluate the protective effect on the ovarian function of the     gonadotropin-releasing hormone agonist (GnRha) administered concomitantly to alkylating     agents. Preliminary data in the literature on animals (rat and monkeys) are promising. Data     in human are, however, highly controversial.   "
252461|NCT01154439|"     RATIONALE: Drugs used in chemotherapy, such as mitoxantrone hydrochloride, cytarabine,     etoposide, and idarubicin, work in different ways to stop the growth of cancer cells, either     by killing the cells or by stopping them from dividing. Everolimus may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood     flow to the cancer. Giving everolimus together with combination chemotherapy may kill more     cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when     given together with mitoxantrone hydrochloride, cytarabine, etoposide, and idarubicin in     treating older patients with newly diagnosed acute myeloid leukemia.   "
252462|NCT01154452|"     This randomized phase I/II clinical trial is studying the side effects and best dose of     gamma-secretase/notch signalling pathway inhibitor RO4929097 when given together with     vismodegib and to see how well they work in treating patients with advanced or metastatic     sarcoma. Vismodegib may slow the growth of tumor cells. Gamma-secretase/notch signalling     pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Giving vismodegib together with gamma-secretase/notch     signalling pathway inhibitor RO4929097 may be an effective treatment for sarcoma.   "
253147|NCT01169714|"     This study is designed to observe the safety and blood concentrations of PF-04995274 during     and following the administration of multiple doses of PF-04995274 for a duration of 14 days,     in healthy adult and healthy elderly.   "
252463|NCT01154465|"     Central venous catheterization (CVC) in ICU is very common. It is associated with many     complications. These complications are now well identified in the literature. They are     primarily mechanical, infectious and thrombotic events. Many measures are taken to reduce     them as the choice of insertion site, strict aseptic technique during insertion and type of     catheter used. However, despite these measures, it appears that the incidence of these     complications is still high. The technique of ultra-sound guided (USG) catheter insertion has     shown its effectiveness in reducing complications in the general ICU population. The increase     in obesity in the general population is accompanied by an increase in the obese population in     the ICU (BMI > 30 kg.m-2). Many studies have investigated the effect of obesity on morbidity     and mortality in ICU. Some studies found a higher rate of catheter infections in obese     patient. Moreover, insertion of central venous catheter is technically more difficult in     obese patients.      To the investigators knowledge there are no studies on the impact of USG central venous     catheterization in obese patients in ICU.      The objective of this prospective randomized controlled study is to demonstrate the     superiority of USG central venous catheterization (jugular or femoral) on complications in a     population of obese patients. 450 patients will be included and dispatched in two groups     (jugular or femoral) according to the chosen site of catheter insertion. In both groups,     patients will be randomized in the USG technique or the usual anatomical technique.      The rate of complications (mechanical, thrombotic or infectious) will be the primary     endpoint. Secondary endpoints will be the following: rate of catheter colonization, rate of     catheter-related bacteremia, rate of failure during insertion, number of punctures, procedure     timing and mortality The investigators hope to establish a benefit in the use of USG central     venous catheterization in obese ICU patients and thus contribute to improve the quality of     care.   "
252464|NCT01154478|"     The aim of this study is to explore if a 8-weeks dietary intervention with polyphenols and     omega 3 fatty acids (alone or combined) may be effective on postprandial lipids metabolism     and other cardiovascular risk factors in people at high cardiovascular risk.   "
252465|NCT01154491|"     In order to evaluate the efficacy of ferric carboxymaltose + erythropoietin versus ferric     carboxymaltose versus placebo in reducing the percentage of patients who receive red-cell     transfusion in the perioperative period of hip fracture, a multicenter, randomized, parallel     groups, double-blind clinical trial in adult patients admitted for osteoporotic hip fracture     is designed. Required sample size is of 87 patients per arm (87x3 = 261). Primary efficacy     variable is the percentage of patients who receive red-cell transfusion during     hospitalization; secondary end-points: average red-cell packs per patient,haemoglobin at 24 h     and 72h after the intervention, at the time of hospital discharge and 60 days after hospital     discharge, hospital stay and mortality during hospital-stay and 60 days afterwards. Adverse     clinical events and side effects are assessed as safety variables. In addition health related     quality of life will be measured at inclusion and after 60 days. A cost-efficacy analysis (by     means of incremental cost-efficacy method using as a primary endpoint each patient not     requiring transfusion, and as secondary end-point every patient who survived the index     admission is performed). The investigators would like to demonstrate a double benefits:     optimizing precious resource such as blood products and reducing complications arising from     their use.   "
252466|NCT01154504|"     1. Study Hypothesis:             -  The decrease of plasma adrenomedullin (ADM) concentration by ultrafiltration and               isovolumetric hemofiltration in patients with acute III and IV Class New York Heart               Association Functional(NYHA) heart failure is more pronounced than a standard               diuretic treatment and is related with clinical improvement.        2. Outcome Measurements:      To correlate the adrenomedullin plasma levels with clinical treatment, ultrafiltration and     hemofiltration related to:        -  Brain natriuretic peptide (BNP) level        -  angiotensin II level        -  sympathetic nervous activity        -  oxydative stress        -  clinical outcome at the beginning, at discharge and 90 days after randomization.   "
252467|NCT01154517|"     The study is trying to prove that the history and physical exam (H&P) in the emergency     department is the most important tool in exam of patients. The investigator is attempting to     correlate the time of the H&P of residents and attendings to the accuracy of diagnosis.   "
252468|NCT01154530|"     Background:      Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a surgical technique that has been     rapidly evolving over the last five years. The technique probably has a great potential in     surgical gastroenterology, urology and gynaecology.      The technique is based on the idea of minimally invasive surgery. The human organism is     affected by a stress response when exposed to surgery. This stress response can be minimized     by reducing the size of the openings whereby the surgeon gains access to the organs. This     affects how quickly a patient recovers after surgery and can be discharged and resumes daily     life and work. The same principal have been responsible for the surgical evolution in the     last 15-20 years where many procedures have gone from traditional open operations with large     incisions in the abdominal wall to laparoscopic surgery with cameras through small holes in     the abdominal wall.      The latest addition to minimal invasive surgery is NOTES. Here the surgeon gains access to     the abdominal organs with flexible endoscopes through the body's natural openings i.e. the     mouth and stomach. With this technique the surgeon avoids cutting through skin and muscle of     the abdominal wall, thus minimizing the surgical stress response. This minimizes     postoperative pain, the incidence of incisional hernias, eliminates wound infection, and     properly prevents scar tissue formation inside the abdominal cavity which way lead to ileus.     The end result is a quicker discharge and a better cosmetic result.      It has been shown in numerous animal studies that NOTES is feasible and in recent years a     rapidly increasing number of published patient series.      However, there is a risk of infection associated with accessing the abdominal cavity through     a natural body opening, which initially is unclean and can not be disinfected in the same way     as the skin of the abdominal wall.      Numerous microbiological pig studies have shown that there is transfer of bacteria from the     body opening (i.e. mouth) to the abdominal cavity when performing NOTES, but this     contamination have no correlation to infection after surgery, neither in terms of healing or     survival.      It is unclear from the literature whether patients should be offered proton pump inhibitor     (PPI) therapy to reduce the acidity of the stomach before NOTES interventions. The rationale     has been that such a treatment can make the gastric juices less acidic and thereby reduce the     incidence of chemical peritonitis, which can occur when acidic juices flows from the stomach     and into the abdominal cavity. It is known however that the acidic environment of the stomach     provides a natural barrier for bacteria. Making the gastric juices less acidic could     potentially increase the risk of bacterial peritonitis.      It is known that the bacterial content of the stomach is low due the acidic environment but     bacteria passed down from the mouth and throat with the endoscope could potentially result in     bacterial peritonitis.      That bacteria from the throat can lead to infections due to instrumentation is known from     intensive care units. Ventilated patients may risk getting pneumonia with bacteria from the     throat. Several studies have shown that using mouthwash with a chlorhexidine solution can     reduce the risk of ventilator associated pneumonia.      Hypothesis:      Mouthwash with 2 cl 0,2% chlorhexidine solution before a gastroscopy reduces the bacterial     content in cultures taken from the stomach and the endoscope after a gastroscopy.      Simultaneous PPI treatment gives higher bacterial counts in the cultures.   "
252469|NCT01154543|"     To determine the efficacy of Famvir 500mg bd as suppressive antiviral therapy for acute     genital Herpes simplex virus (HSV) outbreaks in HIV subjects.   "
252470|NCT01154556|"     An observational retrospective study of NNRTI experienced patients who have virologically     failed. The study aims to assess resistance profiling and subsequent prescription patterns of     patients on NNRTIs   "
252506|NCT01160601|"     This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin     with or without bavituximab in patients that have previously untreated locally advanced or     metastatic non-small cell lung cancer (NSCLC).   "
252471|NCT01154569|"     Bariatric (obesity) surgery has become the preferred treatment option for patients with     severe obesity and is increasing in popularity. It is commonly performed, with nearly 350 000     operations in the world every year. The most common type of bariatric surgery is gastric     bypass, in which stomach size is reduced by 95% and the upper intestine is bypassed. Bypass     of the upper intestine may lead to medication malabsorption, although this potential adverse     effect has received little study.      The objective of this study is to determine whether gastric bypass reduces the absorption of     a azithromycin, a medication commonly prescribed first-line for infections, especially     pneumonia. Patients and non-surgical controls will receive a single dose of azithromycin     under highly standardized study conditions. The absorption of azithromycin will be calculated     and compared between surgical and non-surgical study groups.      The investigators hypothesis is that there will be a significant reduction in the absorption     of azithromycin in gastric bypass patients compared to non-surgical controls. This raises the     possibility that post-gastric bypass patients treated with azithromycin may fail to respond     to treatment, become worse and even die. This study will have important implications for the     large number of past and future gastric bypass recipients.   "
252472|NCT01154582|"     The project aims to precisely quantify the postprandial amino acid utilization of egg     proteins in vivo in humans, and also to assess their satiating power, in relation with     nutrient postprandial waves and incretin secretions. For that purpose, 2 independent studies     are conducted. The first one is realized using stable isotopes on 8 volunteers ingesting an     egg test meal. The second one is a cross over design performed on 30 volunteers to compare     the satiating effect of 2 equivalent snacks: whole eggs or cottage cheese.   "
252473|NCT01154595|"     The overall objective of this project is to assess the effectiveness and cost-effectiveness     of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children     aged 6-36 months if embedded in a program of conditional household food assistance.   "
252474|NCT01154608|"     Pancreatic exocrine insufficiency is known to impair nutrient absorption, especially fat, but     few data exist about protein absorption. We aimed to investigate this question and assess the     enzyme substitution efficiency using a sensitive method.   "
252477|NCT01154647|"     Both patients with peripheral structural pathologies, like rheumatoid arthritis     (RA)-patients, or patients with central sensitivity syndromes (CSS) suffer chronic pain. CSS     are characterized by an increased responsiveness of central pain neurons. An impaired     endogenous pain inhibition is already demonstrated in CSS. In the present study the     investigators want to evaluate the efficacy of pain inhibition in response to physical     stressors and whether the efficacy is opioid-mediated in two chronic pain populations (RA &     CCS) compared to controls.      Therefore a triple-blinded randomized controlled trial (RCT) with cross-over design will be     performed. The efficacy of wind-up of pain and spatial summation of pain is evaluated before     and after a submaximal exercise, while the experimental group receives a selective serotonin     reuptake inhibitor. Participants are 20 RA-patients and 20 CSS-patients, more specific     patients with fibromyalgia and chronic fatigue syndrome, and 30 healthy controls. This way,     the investigators analyze how pain inhibition reacts on different types of physical stressors     in different pain patients and if pain inhibition is opioid-mediated.   "
252478|NCT01154660|"     As increasing tidal volume, the cross sectional area and circumference of Internal Jugular     Vein (IJV) could increase. And In the previous study, Trendelenburg position can increase     size of IJV. So investigators would compare the cross sectional area, circumference of IJV     and peak airway pressure in neutral and Trendelenburg position   "
252479|NCT01154673|"     This trial will investigate the efficacy and safety of intensified antiretroviral treatment     that includes raltegravir and maraviroc during the early stages of HIV infection. With the     proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to     investigate the ability of the combination of raltegravir and maraviroc plus a standard HAART     backbone to further decrease the viral load in acutely infected treated HIV infected     individuals.   "
252480|NCT01154686|"     The overall objective of the current study is to determine whether computerized Working     Memory (WM) training will enhance WM capacity in college students with Attention Deficit     Hyperactivity Disorder (ADHD)/Learning Disabilities (LD). There are also three additional     objectives. The first is to determine whether improvements in WM will generalize to secondary     outcome tasks, such as inhibitory control and planning. The second objective is to examine     whether WM training will also ameliorate ADHD symptoms of inattention and hyperactivity. The     last objective is to investigate whether improvements will be maintained at a two month     follow-up period.      It is expected that the computerized WM training program will enhance WM capacity in college     students with ADHD. In addition, it is believed that these increases in WM capacity will also     lead to improvements in other executive functions. It is also hypothesized that WM training     will lead to a reduction in ADHD symptomology. Lastly, these improvements should be     maintained at three month follow-up.   "
252481|NCT01154699|"     Asthma is an extremely common disorder, which is becoming more prevalent. The purpose of this     study is to examine how nocturnal lung volumes contribute to asthma severity, which may     explain part of the link between asthma and obesity. The investigators seek to test the     hypothesis that raising lung volumes during the night will improve asthma symptoms. The     investigators work may lead to new targets for therapy.   "
252482|NCT01154712|"     Pathological gambling (PG) is characterized by a persistent pattern of continued gambling     behavior despite its adverse consequences. PG is a chronic, progressive, male-dominated     disorder, which has a prevalence of 1% to 3.4% among US adults. Deep transcranial magnetic     stimulation (TMS) is a novel neuro-stimulation method capable of inhibiting neuronal activity     when given in low frequency. The hypothesis of this study is that , Pathological gambling     will be ameliorated if low frequency magnetic field using Brainsway H1 coil will be applied     to the left dorso-lateral prefrontal cortex of these patients.   "
252507|NCT01160614|"     The purpose of this study is to characterize the pharmacokinetics (PK) of single-dose ORF     tablets in pediatric patients aged 6 to 16 years, inclusive.   "
252483|NCT01154725|"     The purpose of the experiment is to study the effect it has on patients' quality of life if     they go through a structured process marked by intensified and specialized effort by ostomy     nurse. This includes close monitoring during hospitalization, telephone contact and guidance     following discharge and participation in a group based patient school up to 4 months after     discharge .      At the same time the study also examines what the economic effect of following the     intervention will have.   "
252484|NCT01154738|"     The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and     remifentanil.   "
252485|NCT01154751|"     Long-term, observational, prospective, multicenter registry following patients who have been     implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in     the superficial femoral and/or femoropopliteal arteries.   "
252486|NCT01160328|"     The male sex hormone, testosterone, plays an important role in determining body fat     distribution in men. This is especially evident in the dramatic shift in body composition as     boys and girls reach sexual maturity. Normal weight women have twice the body fat of a normal     weight man (30% vs. 15% on average) and men will have twice the stomach fat as women (10% vs.     5% of fat as intra-abdominal, men vs. women). These are likely sex-steroid linked events.     Short and long term changes in regional fat distribution accompany testosterone deficiency     and can be reversed by testosterone replacement. Testosterone deficient men have increased     stomach fat that can be reversed with testosterone replacement therapy. Interestingly, the     mechanism by which testosterone affects where we store fat is unknown. It is important to     understand how testosterone influences where we store fat as it is well established that     increased stomach fat results in elevated disease risk.      The proposed study aims to examine the effect of short term, temporary testosterone decreases     on how and where men store fat. The investigators will compare fat storage between men given     Lupron to temporarily decrease testosterone levels those that receive Lupron plus     testosterone replacement vs. a no treatment control group. Comparing these three groups will     allow us to understand the effects of testosterone on short-term changes in fat tissue     function that lead to the long-term changes in where we store body fat.   "
252487|NCT01160341|"     The study is designed to answer the following questions:        1. Is hypogonadism a cause for the metabolic syndrome ?        2. What is the effect of testosterone replacement on the metabolic parameters ?   "
253148|NCT01169727|"     The purpose of this study is to evaluate health status of uncontrolled Chronic Obstructive     Pulmonary Disease (COPD) patients in response to treatments in clinical practice.   "
252491|NCT01160393|"     Atrial fibrillation (AF) is the most common arrhythmia after cardiac surgery. The incidence     of AF varies between 20 - 45 % after (coronary artery bypass grafting) CABG. It may lead to     hemodynamic compromise, thromboembolic events, increased length of stay in the hospital and     increased morbidity. The underlying cause of AF has been related to a variety of factors.     Those most commonly related to the intraoperative management are the use of cardiopulmonary     bypass (CPB), the influence of systemic inflammation, myocardial damage, intraoperative fluid     management and the need of red blood cell transfusion.      The purpose of the study is to find out the difference in the incidence of atrial     fibrillation after CABG when using the conventional (CECC) or mini bypass system (MECC).      The treatment protocol is similar in both groups except the CPB method (CECC vs. MECC). In     both methods the investigators use MAQUET tubing and oxygenator. The investigators also     collect special blood samples for determining most relevant factors found affecting in the     incidence of AF.   "
252492|NCT01160406|"     The aim of the study is to assess the incidence of patients suffering from ischemic stroke or     transient ischemic attacks who have underlying asymptomatic paroxysmal atrial fibrillation.      Patients who have suffered an ischemic stroke or transient ischemic attack, without a history     of atrial fibrillation, are planned to be included. Starting within 14 days of the ischemic     stroke, participating patients are asked to perform 10 second ECG recordings using a handheld     ECG device twice daily (mornings and evenings) during 30 days. These recordings are     transmitted via telephone to a secure encrypted Internet site. Within these 30 days the     participants also perform an ambulatory 24 hour Holter recording. Handheld ECG recordings are     evaluated continuously. In case of atrial fibrillation the patient is informed and offered     treatment with anti coagulant medication (Warfarin). The investigation is a comparison     between 24 hour continuous ECG recordings and short intermittent ECG recordings twice daily     over a longer time period to determine which method is the best to detect atrial fibrillation     in this patient group.      Hypothesis: Short Intermittent ECG recordings over a longer time period is more efficient,     compared with continuous 24 hour ECG recordings, in detecting silent paroxysmal AF in     patients with an ischemic stroke and without a history of atrial fibrillation.   "
252580|NCT01162122|"     The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted     subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing     process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with     respect to immunogenicity in subjects aged 65 years and older. The active comparator     non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United     States and will be used to provide a comparative assessment for immunogenicity and safety.   "
252493|NCT01160419|"     The rationale of the NEO-FLOT-trial consists of an intensification of the neoadjuvant     treatment.      This strategy is based upon the clear advantage of perioperative treatment and the fact, that     in former trials adjuvant treatment could only be given in half of the patients (Cunningham     2006, Boige 2007).      In this study neoadjuvant chemotherapy is applied during a period of 12 weeks with an interim     staging after 6 weeks.Due to the favourable efficacy and toxicity data the FLOT-regimen was     chosen for the neoadjuvant treatment consisting of oxaliplatin, docetaxel, folinic acid and     5-Fluorouracil (Al-Batran 2008).      Postoperative treatment according to the results of the MAGIC trail is not part of the trail     and is given at the responsibility of the participating centres.   "
252494|NCT01160432|"     The aim of the study is to examine the tolerability and abuse potential of the diluted     methadone solution (5 mg/ml → 2 mg/ml) in combination with naloxone in opioid substitution     treatment.      Study hypothesis: Treatment with this diluted combination product is safer than with     methadone alone (5 mg/ml) and combination product does not precipitate withdrawal symptoms in     opioid dependent patients.   "
252495|NCT01160445|"     Background:        -  Aldesleukin (IL-2) is a drug that can help to shrink tumors in some patients with          metastatic renal cancer and metastatic melanoma. It is possible that removing certain          white blood cells (known as CD4 cells) before IL-2 treatment may improve the treatment          effects.        -  Zanolimumab is an antibody that works by destroying CD4 cells in the blood. Researchers          are interested in determining whether zanolimumab can improve the results of IL-2          treatment if it is given before, during, and after IL-2 treatment. In addition, further          research with zanolimumab may provide more information on how IL-2 treatment causes          tumors to stop growing or shrink.      Objectives:      - To evaluate the effectiveness of IL-2 treatment in conjunction with zanolimumab in     individuals with metastatic cancer.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma or     metastatic kidney cancer.      Design:        -  Eligible participants will be screened with a full physical examination and medical          history, imaging studies, and blood samples, including leukapheresis, to remove a sample          of white blood cells for testing purposes. Participants may also have a colonoscopy and          biopsies if they have received previous treatments that have been known to cause colon          damage.        -  Participants will be treated with zanolimumab and IL-2 treatment for 9 weeks.        -  Zanolimumab will be given on an outpatient basis during weeks 1 through 4, 6, 8, and 9.          In weeks 5 and 7, participants will receive zanolimumab as an inpatient in addition to          IL-2 therapy.        -  Inpatient IL-2 treatment will be given during weeks 5 and 7. Up to 15 doses of IL-2          treatment will be given over a maximum of 5 days, followed by inpatient recovery time.        -  During week 5, participants will have tumor imaging studies prior to receiving          zanolimumab and IL-2 treatment.        -  About 2 weeks after the treatment period, participants will return to the clinical          center for a 2-day evaluation with a physical examination, imaging studies, and blood          samples.        -  Participants whose tumors have responded to treatment will be offered up to two          additional courses of treatment, starting 6 to 8 weeks after the last IL-2 dose.          Subsequent courses will be given exactly as described above in the initial course of          treatment. Participants whose tumors do not respond to treatment will have follow-up          evaluations as required by the study researchers.   "
252496|NCT01160458|"     Background:      Background:      - IMC-A12, a new cancer treatment that has not yet been approved by the U.S. Food and Drug     Administration, is an antibody that is designed to block the effects of a protein called Type     I Insulin-Like Growth Factor (IGF-1R). IMC-A12 blocks the receptors in cells that respond to     IGF-1R, which are thought to play an important role in helping cancer cells to grow and     divide. Researchers are interested in determining whether IMC-A12 is an effective treatment     for individuals who have mesothelioma that has not responded to standard chemotherapy.      Objectives:      - To evaluate the safety and effectiveness of IMC-A12 treatment in individuals with     mesothelioma who have previously had chemotherapy.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with mesothelioma that has not     responded to chemotherapy.      Design:        -  Eligible participants will be screened with a full physical examination and medical          history, blood and urine samples, and imaging studies.        -  Participants will receive IMC-A12 once every 3 weeks (21-day cycle), and will be          evaluated before the start of each new cycle with blood tests and imaging studies if          needed.        -  Treatment cycles will continue for as long as needed, unless severe side effects develop          or the disease progresses.   "
253881|NCT01177943|"     To demonstrate the bioequivalence of 12.5 milliliters (mL) of atomoxetine oral solution (4     milligrams per milliliter [mg/mL]) compared with 2 capsules of atomoxetine (25 mg per     capsule) in healthy adult male Japanese subjects.   "
252497|NCT01160471|"     Background:      - Heart failure is a common cardiovascular disorder whose incidence increases with age,     affecting up to 10% of people older than 65 years of age. As the population ages, the     prevalence and cost of heart failure will continue to rise. Researchers are interested in     using noninvasive imaging methods to better understand the symptoms and effects of heart     failure.      Objectives:      - To conduct a noninvasive comparative imaging study of individuals with heart failure.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with heart failure (with at     least mild symptoms and slight limitations on physical activity).      Design:        -  This study will last approximately 2 years and will require four visits to the National          Institutes of Health Clinical Center, with one screening visit and three study visits.        -  Participants will be screened with a full medical history and physical examination, as          well as blood and urine samples.        -  Participants will have the following tests during each study visit:        -  Physical examination        -  Blood and urine samples        -  Cardiac magnetic resonance imaging        -  Cardiac computerized tomography to study the blood vessels in and leading to the heart        -  Echocardiogram to evaluate heart function        -  Electrocardiogram to measure heart electrical activity        -  The three study visits will take place 1 year apart. Participants will also receive          follow-up phone calls 6 months after the first and second visits.        -  No treatment will be provided as part of this protocol.   "
252498|NCT01160484|"     This is a phase II, multicenter, open label, nonrandomized study to evaluate the efficacy and     safety of lenalidomide at a dose of 10 mg/dose in combination with bortezomib at 1.0     mg/m2/dose, pegylated liposomal doxorubicin (PLD) at 4.0 mg/m2/dose, and intravenous (IV)     dexamethasone at 40 mg/dose in adult patients with relapsed/refractory multiple myeloma (MM).     The study consists of a screening period, followed by up to eight 28 day open label treatment     cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a     follow-up period.   "
252499|NCT01160510|"     High mammographic density (HMD) is the strongest risk factor for non-familial breast cancer     apart from age and gender. Studies of sisters and twins suggest that approximately 67% of the     variation in density is attributable to common genetic factors. However, to date, efforts to     identify genetic determinants of HMD have achieved limited success. We and others (Boyd et al     Lancet Oncol 2009) postulate that this lack of progress in identifying genetic determinants     of density is related to a failure to study younger women and misclassification of density.     As women age, their breast tissues undergo atrophy, which is manifested radiologically as a     decrease in mammographic density, resulting in a convergence of density values and a masking     of inter-person variation. This protocol is intended to demonstrate the feasibility of     methods that we plan to use in a full-scale analysis of mammographic density among women     under age 50 years who receive care at the University of Vermont, Fletcher Allen Health Care     (FAHC) and have been followed through the Vermont Breast Cancer Surveillance System (VBCSS).      The Hormonal and Reproductive Epidemiology Branch (HREB) is currently conducting a     cross-sectional study entitled, Breast Radiology Evaluation and Study of Tissues (BREAST)     Stamp Project which aims to understand why mammographically dense tissues are related to     elevated breast cancer risk. This project is being conducted within the VBCSS using breast     cancer awareness Stamp Act funds. The BREAST Stamp project has focused on women between the     ages of 40-65 years who were referred for radiologically-guided biopsy to evaluate an     abnormality identified on a screening mammogram. The study has successfully enrolled over 400     women with collection of questionnaires, buccal and blood samples, and tissues. The study     will continue recruiting through May 2010, with a targeted enrollment of 450-500 women.     Through the infrastructure developed for the BREAST Stamp Project, mammographic volumetric     density data, assessed using a novel method with density phantoms developed at UCSF, has been     collected on approximately 25,000 screened women of all ages from February 2008-present.      The current protocol describes a study in which we propose to capitalize on infrastructure     that has been established through the BREAST Stamp Project. We propose to perform this study     in two phases: Phase one will be a feasibility study: specifically, we propose to demonstrate     that we can use a mailing to collect Oragene tube format saliva collection kits as a source     of germline DNA and a short self-administered questionnaire. This collection of specimens and     data will be used to inform the launch of phase two, the full-scale study to identify     determinants of mammographic volumetric density among approximately 10,000 women less than 50     years of age for whom raw images and density data are already collected. During the first     phase we hope to demonstrate feasibility by achieving at least 60% participation with     unbiased representation of subjects with regard to demographics and volumetric density     measurements. Once feasibility of this approach is established, we propose to launch the     full-scale study by contacting the remaining (approximately 10,000) women with existing     volumetric density data to collect questionnaires and DNA samples necessary to delineate the     genetic determinants of mammographic density, as well as to investigate hypothesized risk     factors for mammographic density and breast cancer risk, such as alcohol intake, cigarette     smoking, and breastfeeding history.   "
252508|NCT01160627|"     OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients     with ST segment elevation myocardial infarction treated with primary percutaneous coronary     intervention.      DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a     rise in creatinine >25% from baseline Serum creatinine will be measured at baseline and each     day for the following 3 days and at 30 days.      Patients will be randomised to:        1. Standard treatment        2. Standard treatment + acetylcystein for 2 days        3. Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours        4. Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by          100 ml/h for 5 hours   "
252581|NCT01162135|"     The purpose of this study is to assess the effectiveness of dioxin on prohibiting prostate     cancer progression as measured by PSADT (prostate-specific antigen doubling time).   "
252500|NCT01160523|"     Background: Podoconiosis is a debilitating condition affecting one million people in     Ethiopia. Podoconiosis is preventable if those at genetically high risk consistently     protected their feet from exposure to silica nanoparticles present in clay soil. Despite the     efforts of a local Non-Government Organization (NGO) the Mossy Foot Prevention & Treatment     Association (MFTPA) to distribute shoes to podoconiosis patients and their children, use of     footwear is intermittent. This protocol proposes a collaboration among faculty from NHGRI,     Addis Ababa University, and the MFTPA to develop and test intervention approaches that have     the potential to be sustained by the community, to motivate children from families affected     by podoconiosis to consistently wear shoes.      Objective: The three primary aims are to: (1) use qualitative assessment strategies to     explore factors influencing shoe use among high-risk children; (2) use these findings to     develop culturally-tailored intervention modules; and (3) evaluate in a randomized trial the     individual and joint effects of the intervention modules in encouraging high-risk children to     consistently wear shoes.      Population: Children (ages 9 -15) from families affected by podoconiosis who are     participating in shoe distributions in one of 13 communities in the Wolaita zone of Ethiopia     served by MFTPA.      Methods: Guided by the PRECEDE-PROCEED approach to planning, implementing and evaluating     public health programs, a two-phase study is proposed.      Phase 1 will employ qualitative methods including participant observation, extended case     studies, key-informant interviews and focus group discussions in a sample of 4 communities to     gain understanding of the factors that influence shoe wear among high-risk children. Informed     by these results, content for two modules (an enhanced education module and a role model     support module) will be developed with the aim to motivate consistent use of footwear.      Phase 2 will evaluate the individual and joint effectiveness of the two intervention modules     in a randomized 2 x 2 factorial design with communities assigned randomly to one of 4     intervention conditions: (GP1) no enhanced health education and no role model support (usual     care), (GP2) enhanced health education without role model support, (GP3) no enhanced health     education with role model support, and (GP4) enhanced health education and role model     support. All children receive shoes. Children will be surveyed at baseline, 3-5 days after     shoe distribution, and again, 3- and 6- months post baseline.      Outcomes: The primary outcome is a composite of direct observation of shoe use, self-reported     shoe use, and baseline-to-follow-up changes in the children s foot appearance based on a     visual foot exam.   "
252501|NCT01160536|"     This study proposes to describe how children s hypertrophic cardiomyopathy (HCM) risk status     affects family functioning, behaviors, and relationships. HCM is the most common inherited     cardiovascular single-gene disorder. Individuals with HCM may experience shortness of breath,     chest pain, palpitations, dizziness, syncope, heart failure, and arrhythmias predisposing to     sudden cardiac death at any age. Notably, HCM is the most common cause of sudden cardiac     death in people under 30 years of age. Genetic testing can identify at-risk individuals;     however, the impact of potentially life-altering genetic information on families remains     largely unexplored. Increasingly, health care providers are providing the testing in children     for conditions like HCM that are life-threatening and medically manageable without the     benefit of understanding the psychological consequences. The few studies that have been     conducted suggest that genetic testing in children may result in changes to family     relationships, parental emotional wellbeing, parenting behaviors, and child functioning in a     subset of children. One synthesis of these studies suggests that children as a group show     little evidence for maladjustment to risk information, but that parents are affected by the     carrier status of their children. The proposed study intends to further this body of     knowledge by exploring the impact of children s risk status on families with HCM. Health care     providers and researchers can inform their work with HCM families by better understanding the     potential impact of genetic risk as an important component of families adaptation to the     life-threatening information about their children. The families targeted for this exploratory     study will be purposively sampled from those that have been aware of the children s risk     status or not at-risk status for HCM for at least 3 months. The cross-sectional design is     composed of semi-structured interviews with a parent and, separately, with his/her 13 to 23     year-old child who is either a carrier for HCM, a non-carrier, or at 50% risk for being a     carrier. The interview will target issues related to the perceived impact of the child s risk     status on family functioning, parenting behaviors and relationships. Data from the     parent-child dyads will be analyzed for concordance/discordance along parallel themes. The     results of this study may facilitate the understanding of the perceived impact of learning     children s HCM risk status, which will inform both clinical care and future research.     Importantly, since predictive testing in children for adult-onset diseases is generally     discouraged, very little is actually known about its impact on families. Therefore, the study     of this unique subgroup of an HCM population that uses clinically indicated predictive     testing in childhood offers a preliminary opportunity to learn about predictive testing of     minors.   "
252659|NCT01163149|"     This clinical trial is being conducted to study hypophosphatasia (HPP), a bone disorder     caused by gene mutations or changes. These gene mutations cause low levels of an enzyme     needed to harden bone. The purpose of this study is to test the safety and efficacy of two     doses of the study drug called asfotase alfa as compared to a control group to see what     effects it has adolescents and adults with HPP.   "
256175|NCT01261728|"     The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin     for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing     surgery for kidney cancer.   "
252502|NCT01160549|"     International variation in breast cancer rates and data from migrant and animal studies     support the possibility that exposures early in development, including the in utero period,     play a role in breast carcinogenesis. One of the most striking prenatal influences on breast     cancer risk is whether the woman was born in a country with a low or high breast cancer     incidence. This observation has led to interest in the degree to which in utero exposures     vary by the maternal environment, and to the hypothesis that alterations in prenatal     concentrations of steroid hormones, particularly estrogens, and other biologic parameters to     which the fetus is exposed mediate differences in subsequent breast cancer risk.      There are striking differences in breast cancer incidence rates between Asian and North     American and Western European populations, but variation within Asia is also wide. Incidence     in Mongolia is one of the lowest in the world (6.6/100,000) while China, its neighbor to the     south, has about three times this rate (18.7/100,000). Furthermore, rates appear higher in     urban than in rural areas. Over the last decade and a half Mongolia has experienced profound     economic changes resulting in mass migration from a nomadic or semi-nomadic existence to a     more western lifestyle in the capital city of Ulaanbaatar. Together with the contrast in     exposures between traditional and urban settings, migration presents the opportunity to study     women as they acculturate to a more western lifestyle.      We propose collecting maternal and cord blood samples from pregnant Mongolian women and their     offspring living in rural and urban areas to describe concentrations of several steroid     hormones and growth factors. The purpose of the study is to assess whether the in utero     environment differs in women living a traditional lifestyle compared with a more urban     lifestyle, and by degree of western acculturation among those who have recently migrated to     the capital. Maternal and cord blood samples from an ongoing cohort study being conducted at     the University of Pittsburgh will provide a comparison group of US women.   "
252503|NCT01160562|"     Plasmodium falciparum malaria remains a global public health threat. Leading malaria vaccine     candidates confer only partial short-lived protection at best. An understanding of the     mechanisms by which humans acquire malaria immunity through repeated P. falciparum infections     may aid the development of a malaria vaccine. This pilor study is designed to initiate the     epidemiological groundwork for a future prospective cohort study of acquired malaria immunity     in Kalifabougou, Mali, a rural village of approximately 5 000 individuals who are exposed to     seasonal P. falciparum transmission each year from July through December. This study will     estimate the age-stratified point prevalence of P. falciparum infection before the malaria     season and at the peak of the 6-month malaria season, and it will estimate the age-stratified     incidence of symptomatic p. falciparum infection during the 6-month malaria season. The     spatial distribution of asymptomatic P. falciparum infections and incident malaria cases     within the village of Kalifabougou will be determined by merging the prevalence and incidence     data with census and Global Positioning System (GPS) data.   "
252504|NCT01160575|"     With an estimated 2.5 million HIV-infected persons, India is home to one of the largest     populations of HIV-infected persons in the world. Yet, it is estimated that less than 20% of     the people living with HIV in India are aware of their status. Andhra Pradesh (AP), situated     in south India, is the state with the highest HIV burden in India. Reports from AP suggest     usage of voluntary counseling and testing (VCT) is low, especially among high-risk groups.     VCT has been shown to have many benefits in addition to diagnosis of HIV infection such as     reduction in risk behavior, partner referral, and serving as an entry point to the health     care system. Community mobilization and VCT vans have been shown in the past to play a role     in increasing utilization of VCT services in various developing countries similar to India.     The primary objective of this protocol is to arrive at an effect size of community     mobilization alone, and both community mobilization and VCT vans, on the adoption of VCT     services in Andhra Pradesh, India. Secondary objectives include identifying barriers to VCT,     assessing stigma in the community, and establishing a specimen repository at the YRGCARE     infectious disease laboratory in Chennai, India. We will achieve these objectives by     conducting a cluster randomized clinical trial with 3 arms: ARM 1: standard of care with     pre-existing VCT centers (SVCT); ARM 2: community mobilization in the setting of pre-existing     VCT centers (CVCT); ARM 3: community mobilization plus VCT van in addition to the     pre-existing VCT centers (MCVCT). The overall study duration will be 6 months from     randomization. To our knowledge, this is the first study to examine the role of community     mobilization and VCT vans on the adoption of VCT in the Indian context. It will provide us     with vital data that will be used to plan a larger powered study to evaluate the     effectiveness of these interventions including sites from other parts of India. Additionally,     this study will also provide us with important information on barriers to VCT in these     communities.   "
252509|NCT01160640|"     This study is a randomized placebo-controlled trial comparing two antibiotic treatment     regimens for acute PID. Women with acute PID will be randomized to one of two treatment     regimens: 1) a single intramuscular dose of ceftriaxone 250 mg, doxycycline 100 mg orally     twice a day for 14 days, along with placebo tablets orally twice a day for 14 days or 2) same     doses of ceftriaxone and doxycycline, and metronidazole 500 mg orally twice a day for 14     days. The primary objective is to compare the eradication of anaerobic organisms from the     upper genital tract between women who receive standard outpatient antibiotic treatment to     those who receive standard outpatient treatment along with a two-week course of     metronidazole.   "
252510|NCT01160653|"     The purpose of this study is to test a unique, combined cognitive and motor intervention     designed to restore safe, more normal coordinated gait components into the real world     environment for individuals with stroke.   "
252511|NCT01160666|"     Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF     (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis     of SS in both systemic and glandular features, and B cell downregulation may lead to a     decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic     lupus erythematosus, where Belimumab has been proven to be effective.   "
252512|NCT01161238|"     The goal of this project is a useful clinical instrument for diagnosis and treatment of     residual limb volume fluctuation in individuals who use prosthetic limbs. One hypothesis to     be tested is that the instrument effectively measures short and long term volume fluctuations     in individuals with trans-tibial amputation. Another hypothesis to be tested is that when     subjects add a sock or insert to the prosthesis residual limb volume decreases, and when they     remove the sock or insert residual limb volume increases.   "
252522|NCT01161368|"     The objective of this phase II study is to gain first information on the efficacy (PFS, ORR     and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive metastatic     breast cancer pretreated with a combination therapy (chemotherapy and/or hormonal therapy)     including lapatinib and presenting with tumor progression.      Primary objective is to assess the efficacy with respect to the percentage of patients     surviving without disease progression as assessed by RECIST criteria.      Secondary objectives are to assess the efficacy of the study treatment with respect to the     objective response rates as assessed by RECIST criteria version 1.1, the overall survival and     to evaluate the safety profile of the combination by recording the adverse events and     abnormal laboratory values associated with the study treatments.      The main efficacy endpoints will be investigated both for the intent-to-treat (ITT)     population and the per-protocol (PP) population.   "
252833|NCT01165736|"     The purpose of this study is to calculate the pharmacokinetics (concentration of compound in     and rate of excretion from the blood) following a very low dose of compound which will not     have any pharmacological activity and to monitor for the safety and tolerability of each of     the compounds in the study.   "
252513|NCT01161251|"     Atrial fibrillation (AF) is the most common sustained dysrhythmia encountered in clinical     practice in North America and Europe, accounting for approximately one-third of all     hospitalizations for a cardiac rhythm abnormality. The presence of AF markedly increases the     patient's risk for developing arterial embolism and stroke, depending on the presence of     other clinical conditions, such as hypertension and diabetes. AF is associated with a     fivefold increased risk for stroke, and is estimated to cause 15% of all strokes.      Patients with AF frequently have several risk factors for atherosclerosis, including     hypertension, diabetes, and dyslipidemia. Accordingly, systemic signs of atherosclerosis can     be detected in AF patients, and these likely accounts for an enhanced risk of coronary heart     disease. In addition to cerebrovascular disease, patients with AF may suffer from coronary     events including myocardial infarction (MI), but the rate of MI in AF patients seems to be     variable, but often underestimated.      Moreover, coexistence of peripheral arterial disease (PAD) is a relevant clinical sign of     systemic atherosclerosis.      Ankle-brachial index (ABI) is a simple, inexpensive, and non-invasive PAD measurement, even     at the pre-symptomatic phase when intervention can improve prognosis and prevent or delay     severe complications ABI is calculated by measuring the systolic blood pressure in the     posterior tibial and/or the dorsalis pedis arteries either in both legs or 1 leg chosen at     random (using a Doppler probe or alternative pulse sensor), with the lowest ankle pressure     then divided by the brachial systolic blood pressure. In addition to peripheral artery     disease, the ABI also is an indicator of generalized atherosclerosis because lower levels     have been associated with higher rates of concomitant coronary and cerebrovascular disease,     and with the presence of cardiovascular risk factors.      Two large studies in patients with AF document the existence of PAD in about 3-5% of     patients. It is possible, however, that such an incidence has been underestimated as only     symptomatic patients were considered as affected by PAD. As PAD is an important marker of     systemic atherosclerosis, its association with AF reinforces the concept that patients with     AF have systemic atherosclerosis that potentially account for coronary complications.      To date, a national registry of AF patients is not available to verify the real impact of     cardiovascular events in this clinical setting.   "
252514|NCT01161264|"     Influenza poses a significant threat to individual and public health, and influenza     vaccination with a trivalent inactivated influenza vaccine is widely recommended to children,     adults at risks and elderly. Due to antigenic changes of influenza viruses, the virus strains     used in interpandemic influenza vaccines are adjusted every year according to WHO (World     Health Organization) and CHMP (Committee for Medicinal Products for Human Use)     recommendations. Following a change in the vaccine antigen composition recommendation from     the previous season, immunogenicity and tolerability of the newly composed vaccines are     subject of evaluation in an annual clinical trial in non-elderly adult and elderly subjects     according to the guidelines set by EMEA (CPMP/BWP/214/96).   "
252515|NCT01161277|"     The main objective is to investigate if the brain activation signature of a typical     antipsychotic agent is dissociable from a newer drug with a pharmacological profile that     differs from both typical and atypical antipsychotics since it is a potent partial D2     agonist. The method used to study this will be functional magnetic resonance imaging (fMRI).   "
252516|NCT01161290|"     HYPOTHESIS:The study purpose is to evaluate the effectiveness of a structured pursed-lips     breathing (PLB) protocol taught via real-time interactive telecommunication with a home     computer using the lnternet and Skype software in veterans with chronic obstructive pulmonary     disease (COPD. The primary hypothesis is veterans with COPD and dyspnea on exertion who     receive a PLB educational intervention taught via weekly interactive telecommunication over a     4-week period will have greater reduction of exertional dyspnea compared to those who receive     the PLB educational intervention with no weekly interactive sessions.      RESEARCH PLAN: An experimental two- group design is used. All subjects receive a brief 5 - 10     minute one-on-one PLB educational session. Subjects are then randomized to either the     intervention group or the control group. The intervention group receives 4 weekly interactive     group sessions with the health educator (principal investigator)via computer. A free software     program known as Skype allows synchronous video and audio interaction. The comparison group     receives only the brief PLB educational session with no weekly follow-up.      RESULTS: At end of 4 weeks, the intervention group had significantly lower dyspnea intensity     scores (group X time interaction F = 6.69, p = 0.02) and significantly higher social support     scores (group x time interaction F = 4.34, p = 0.058).      CLINICAL SIGNIFICANCE: Skype is a viable means for providing patient education. A structured     PLB protocol provides significant differences in exertional dyspnea over time. A structured     PLB protocol plus Skype showed significant reduction in patients' sense of dyspnea intensity     and increased social support scores.   "
252517|NCT01161303|"     We have developed in vitro systems including primary epithelial cell cultures and explant     cultures of bronchial tissues to study the interaction between the bronchial mucosa and     allergens. This approach involves culturing bronchial biopsies under optimal conditions and     stimulate them with allergens thus enabling us to perform a dynamic study without the need of     performing several bronchoscopies and will allow the testing of unapproved substances, which     could, otherwise, not be delivered, in vivo.      We wish to apply these ex vivo bronchial culture systems to assess cytokine release in     moderately severe asthmatics and evaluate the effects of blocking TNF-alpha signalling using     anti TNF-alpha monoclonal antibodies.   "
252519|NCT01161329|"     Chronic conditions such as stroke are associated with physical disability and an economic     burden for the family and the society. A medical approach is often not sufficient to address     the bio-psychological process of chronic disease. Behavioural medicine approaches are often     needed to improve the treatment outcomes. Those approaches have often successfully been used     together with physical activity to change health behaviour in inactive individuals and in     pain management. In this project the combined approach of behavioural medicine principles and     physical training will be tried on patients who have had a stroke one year ago where it has     yet only been used scarcely. As the study focus on the individuals' ability to function and     be active the primary outcome measure is disability. The aim of the study are in a randomized     controlled study evaluate if a high intense functional exercise program as an group     intervention under three months can influence functional, psychosocial, anthropometric and     biochemical factors 3, 6 months and 1 year after the start of the study. Following outcome     variables will be analyzed:        1. level of physical activity, motor function and balance        2. depression and health-related quality of life        3. body mass index (BMI), metabolic risk profile, inflammation status        4. number of falls, fall-related self-efficacy and outcome expectations   "
252520|NCT01161342|"     The aim of the study is to estimate the prevalence of malnutrition among older adults     admitted to hospital and to analyse predictive factors for malnutrition. Further, the aim was     to analyse the association between nutritional status and all-cause and cause-specific     mortality.      The hypothesis is that malnourished patients have a higher mortality then well-nourished     patients after three years.   "
252521|NCT01161355|"     The primary objective of this study is to assess the absolute bioavailability and to evaluate     pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of     [14C]AZD9668 in healthy male subjects.   "
252523|NCT01161381|"     Objective: Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a common sleep disorder     requiring the time and money consuming full polysomnography to be diagnosed. Alternative     methods for initial evaluation are sought. The investigators aim was the prediction of     Apnea-Hypopnea Index (AHI) in patients suspected to suffer from OSAHS using two models based     on nonlinear analysis of three biosignals during sleep.      Methods: One hundred patients referred to a Sleep Unit underwent full polysomnography. Three     nonlinear indices (Largest Lyapunov Exponent, Detrended Fluctuation Analysis and Approximate     Entropy) were extracted from three biosignals (airflow from a nasal cannula, thoracic     movement and Oxygen saturation) providing input to a data mining application for the creation     of predictive models for AHI.   "
252524|NCT01161394|"     Pioglitazone decreases oxidative load, inflammatory end points and improves vascular     reactivity in obese patients in a dose dependent manner and that this effect is independent     of its glucose lowering effects.   "
252525|NCT01161407|"     The purpose of this study is to gain a better understanding of calcium absorption and     metabolism in patients with Chronic Kidney Disease (CKD) using calcium balance and kinetic     methods.   "
252526|NCT01161420|"     The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the     Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat     moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of     the hypoglossal nerve. Study objectives include demonstrating that the Inspire system     improves key indices of sleep apnea in a pre-specified percentage of patients.   "
252527|NCT01161433|"     Spirometry is a recommended component of asthma diagnosis and treatment in the primary care     setting, however, few primary care providers report routine use of spirometry in the     provision of care for their asthma patients. Even when spirometry is used to aid in asthma     severity classification, primary care providers have a high rate of failing to meet the     quality goals for testing established by the American Thoracic Society.      The goal of this study is to evaluate the effectiveness of a virtually delivered quality     improvement (QI) program. The program is designed to train primary care providers and their     medical staff in the use of spirometry to improve pediatric primary care management for     children with asthma.   "
252528|NCT01161446|"     The purpose of this study is to determine whether the availability of home self-testing for     HIV will increase HIV testing frequency among men who have sex with men without negatively     impacting their risk for HIV acquisition.   "
252529|NCT01161459|"     The purpose of this study is: To explore the potential role of Tripterygium wilfordii plus     steroid in the treatment of membranous nephropathy.      To investigate the safety and tolerability of Tripterygium wilfordii plus steroid   "
252530|NCT01161472|"     The study is designed to evaluate elements of cognitive function in subjects receiving either     fesoterodine or alprazolam.   "
252542|NCT01161628|"     Rituximab is an attractive agent to bring to the upfront treatment of chronic     graft-versus-host disease (cGVHD) due to its favorable toxicity profile, its proven efficacy     in the treatment of steroid-refractory cGVHD, and its ability to serve as a steroid sparing     agent in other autoimmune diseases. The investigators hope to demonstrate that Rituximab has     significant activity in cGVHD when utilized early in the course of the process. In addition,     the investigators hope to show that the early use of Rituximab may allow for the earlier     discontinuation of immunosuppression while obviating the need for long courses of systemic     corticosteroids, which should translate into reduced treatment-related morbidity and     mortality associated with cGVHD.   "
252531|NCT01161485|"     There is a need to identify and test effective strategies to reduce meth use and human     immunodeficiency virus (HIV) risk behaviors in heterosexuals. This project will compare the     efficacy of a manually-driven HIV testing and counseling (HIV T/C) intervention, with HIV T/C     plus a manualized Contingency Management (CM), with HIV T/C plus CM plus a manualized     Strengths-Based Case Management (CM/SBCM) model. As HIV T/C is the standard of care, the     investigators are testing to determine if the investigators can enhance this standard. The     specific aims and hypotheses of this protocol are:        1. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing drug use,          specifically meth use. Hypothesis 1: CM/SBCM will reduce drug use more than those in CM          (which will have more reduction than HIV T/C), potentially mediated through increased          service utilization.        2. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing HIV and STI          risk behaviors, specifically sex risk behaviors but also needle risk for injection drug          users (IDUs). Hypothesis 2: CM/SBCM will have greater decreases in HIV risk behaviors          than those in CM (which will have greater decreases than HIV T/C), potentially mediated          through reduced drug use.        3. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on improving mental          health status. Hypothesis 3: CM/SBCM will have greater improvements in mental health          status than those in CM (which will have greater improvements than HIV T/C), potentially          mediated through increased service utilization and reduction of drug use, and          potentially moderated by baseline meth use.   "
252532|NCT01161498|"     This study is being conducted to learn about the safety and risks of using talimogene     laherparepvec to treat patients with head and neck cancer and to see if talimogene     laherparepvec and chemoradiation together can destroy the tumours versus the use of     chemoradiation alone. This study may provide information on the usefulness of talimogene     laherparepvec combined with chemoradiation as a future treatment for head and neck cancer.   "
252533|NCT01161511|"     This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574.     The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended     dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK,     PD and immunogenicity, and to evaluate preliminary antitumor activity of XmAb5574 in patients     with relapsed or refractory CLL/SLL.   "
252534|NCT01161524|"     This study is designed to investigate the short- and long-term effects of perampanel on     cognition, growth, and development in adolescents.   "
252573|NCT01162031|"     We hope to learn more about the clinical efficacy of bortezomib in T-cell prolymphocytic     leukemia. Patients will be selected as a possible participant in this study because they have     a bone marrow disorder known as T-cell prolymphocytic leukemia (T-cell PLL) which does not     tend to respond well to conventional treatment with chemotherapy.   "
252535|NCT01161537|"     Cystic Fibrosis (CF) is caused by mutations in the cystic fibrosis transmembrane conductance     regulator (CFTR) gene. The encoded protein, CFTR, is an epithelial chloride ion channel     responsible for aiding in the regulation of salt and water absorption and secretion in     various tissues. Although the disease affects multiple organs, the leading cause of mortality     is the progressive loss of lung function. Obstruction of airways with thick mucus, chronic     bacterial infection of the airways, and inflammatory response are all thought to play a role     in causing lung damage. Through its function as a chloride channel, CFTR is believed to be     integral in epithelial ion and water transport and hence, maintaining the normal hydration of     lung secretions.      VX-770 (ivacaftor) is a potent and selective potentiator of wild-type, G551D, F508del, and     R117H forms of human CFTR. Based on in vitro studies and pharmacologic, pharmacokinetic (PK),     and safety profiles, VX-770 has been selected for clinical development as a possible     treatment for patients with CF.      Hyperpolarized noble gas magnetic resonance imaging (HG-MRI) is a promising new means of     assessing lung function by direct imaging of certain non-radioactive isotopes of an inert     noble gas, such as helium or xenon. Through this technique, high-resolution 3-dimensional     images of lung ventilation can be obtained in both pediatric and adult patients during a     single short breath-hold following inhalation of the gas.      This is a 2-part study to evaluate the effect of VX-770 on hyperpolarized helium-3 magnetic     resonance imaging (3He-MRI), and to evaluate the safety and efficacy of VX-770 in subjects     aged 12 years and older with CF who have the G551D-CFTR mutation. Part A is a single-blind,     placebo-controlled study that includes 4 weeks of VX-770 treatment and 4 weeks of placebo     treatment. Part B is an open-label, 48 week study of long-term effect of VX 770 on     hyperpolarized 3He-MRI.   "
252536|NCT01161550|"     This study will evaluate the investigational drug Midostaurin in various doses given with     ATRA and CLAG chemotherapy. Midostaurin is a FLT3 inhibitor that is activated or     overexpressed in a significant proportion of AML patients. Research has shown that     midostaurin and drugs like midostaurin may work better in combination with chemotherapy, like     CLAG. CLAG is a combination of cladribine, cytarabine, and G-CSF which is approved by the FDA     and used to treat AML.   "
252537|NCT01161563|"     The purpose of this study is to compare how subjects feel after receiving injections of two     different types of GnRH six months apart. One injection is given under the skin of the     abdomen, and the other one into the muscle of the buttock or thigh.   "
252538|NCT01161576|"     This is a proposed follow up study on the investigators previous gene transfer human clinical     trial entitled Administration of a Replication Deficient Adeno-associated Virus Gene     Transfer Vector Expressing the Human CLN2 cDNA to the Brain of Children with Late Infantile     Neuronal Ceroid Lipofuscinosis (Weill Cornell IRB# 0401007010). As in the previous study,     the investigators propose to administer a biologic by direct gene transfer into the brain and     assess its safety on children with a fatal genetic disease of the CNS. The disease is Late     Infantile Neuronal Ceroid Lipofuscinosis (LINCL, a form of Batten disease). This will be     accomplished by using delivery of a gene (method called gene transfer) to administer to the     brain an experimental drug called AAVRh.10CUhCLN2, a gene transfer vector.   "
252539|NCT01161589|"     The purpose of this clinical study is to collect simultaneous, multiple view cardiac signals     representing both transvenous ICDs (T-ICD) and sensing vectors from the subcutaneous     implantable defibrillator system (S-ICD). Upon completion, this data will represent the first     true database capable of comparing detection characteristics of transvenous and subcutaneous     ICDs. Future protocols will be created to dictate the specific methods of such comparisons.   "
252540|NCT01161602|"     The purpose of this study is to determine if pumosetrag is effective in treating     Gastroesophageal Reflux Disease (GERD) symptoms in patients who have a history of GERD     symptoms and are currently taking an acid suppression therapy, such as a Proton Pump     Inhibitor (PPI).   "
252541|NCT01161615|"     A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the     Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the     Treatment of Tendonitis and Bursitis of the Shoulder.   "
252670|NCT01163292|"     The present survey was conducted to evaluate the effectiveness and safety of treatment with     adalimumab during the 52-week period following completion of the treatment period in Study     NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.   "
252543|NCT01161641|"     Protein Losing Enteropathy (PLE) is a serious medical condition that may develop in children     and adults with congenital heart disease for which a palliative procedure known as the     Fontan procedure has been performed. The loss of serum proteins into the gastrointestinal     tract that is associated with PLE can cause serious symptoms and life-threatening     complications. A number of clinical studies have suggested that heparin administration can     have clinical benefit in children with PLE, however the risk of bleeding associated with the     administration of heparin is an important concern and commonly limits its administration.     ODSH is a desulfated heparin with minimal anticoagulation properties but which, in     pre-clinical studies, appears to have the potential to replace heparin and greatly reduce the     risk of bleeding. This open label study is to assess the safety and evidence of therapeutic     effect of the administration of ODSH as a 4-day continuous intravenous infusion in patients     with an exacerbation of their PLE.   "
252544|NCT01161654|"     The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride     Tablet under fed conditions.   "
252545|NCT01161667|"     The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride     Tablet under fasted conditions.   "
252546|NCT01161680|"     This project will examine the current diagnosis and treatment of bone health in patients with     obstructive airway disease. Patients will be referred to The Osteoporosis Centre of BC (OCBC)     by their respirologist to be assessed for osteoporosis including Dual Energy Xray     Absorptiometry (DXA) scan. Previous chest xrays and will be accessed and examined for     vertebral fractures, diagnostic of osteoporosis. The lung and bone data will be entered into     a database. This will allow us to explore the relationship of lung disease parameters to     osteoporosis predictors, eventually determining a respirology patient population who are at     high risk of fracture. Longitudinal evaluation of bone health and its relationship to     respiratory parameters over time will be explored by follow-up evaluations at 12 and 24     months.   "
252585|NCT01162187|"     All contemporary guidelines for secondary prevention in acute coronary syndromes recommend a     combination of aspirin, beta-blockers, ACE-inhibitors and statins. Yet underutilisation of     these drugs is common. We do not know in detail what drives underutilisation, nor what its     long term consequences are for survival after discharge from hospital. Also unknown is     whether potential adverse effects of underutilisation are the same for individual secondary     prevention drugs.      This study will assess the impact of secondary prevention underutilisation on survival.   "
252547|NCT01161693|"     This study will randomly allocate 180 women undergoing elective C-sections under combined     spinal epidural (CSE) Anesthesia at BC Women's Hospital to one of three groups: Standard     Pillow under Head (Control), Head Elevated in Ramped Position immediately after regional     anesthesia (HERP), or Head Elevated Ramped Position horizontally- Horizontal until     establishment of anesthesia and then head elevated for the surgical procedure (HERP-H). The     subjects will be monitored for blood pressure changes (hypotension), comfort levels and time     to adequate level of the anesthetic block obtained with the CSE. The study will determine if     positioning a parturient in the ramped position using an elevation pillow will significantly     increase the time for anesthesia to reach the dermatome level of T4 as well as whether it     increases maternal comfort and provides a better airway position for the parturient.   "
252548|NCT01161706|"     The purpose of the investigators study is to investigate the impact of a commercial vegetable     juice on dietary vegetable intake and select cardiovascular risk factors in a generally     healthy population. The study was a 12 week study with 3 groups who received 0, 8 or 16 fluid     ounces daily of vegetable juice, along with education on the DASH (Dietary Approaches to Stop     Hypertension) diet. All participants came in for 3 study visits at 0, 6 and 12 weeks into the     study.   "
252549|NCT01161719|"     The purpose of this study is to evaluate the effectiveness of group parent training taught     through videoconferencing on ADHD treatment via a comparison between participants using     traditional face-to-face parent training sessions and a group using teleconferencing.   "
252550|NCT01161732|"     The optimal timing of surgical intervention remains controversial in asymptomatic patients     with very severe aortic stenosis. The investigators therefore try to compare long-term     clinical outcomes of early surgery with those of conventional treatment strategy in a     prospective randomized trial.   "
252551|NCT01161745|"     The investigators want to identify that whether PD-1/PD-L1 pathway will change in human     sepsis, and whether PD-1/PD-L1 pathway play an important role in sepsis induced     immunosuppression.   "
252552|NCT01161758|"     Passive accessory cervical mobilization is widely used as a clinical approach to the     management of musculoskeletal pain of spinal origin. The purpose of the study is to determine     if passive cervical mobilization can improve motor function in situations where motor     performance is not impaired by the presence of pain.   "
252553|NCT01161771|"     This is a multicenter evaluation of the effects of the cataract extraction and limbal     relaxing incisions (LRI) on corneal sensation and dry eye signs and symptoms.   "
252554|NCT01161784|"     The purpose of this study is to determine the effects of daily consumption for 4 weeks of a     fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain     Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation.   "
252555|NCT01161797|"     The aim of this study was to evaluate the correlation between 1,5-Anhydroglucitol in patients     with HbA1C <7%, and glycemic excursions as assessed by the continuous glucose monitoring     system compared to fructosamine.   "
252556|NCT01161810|"     This project will develop a descriptive database of patient information and patient outcomes.     This database will be used to determine the association of time spent in rehabilitation and     patient outcomes, to relate patient acuity to burn scar contracture development and to     establish minimal time requirement guidelines for various rehabilitation patient outcomes.   "
252570|NCT01161992|"     Primary Sclerosing Cholangitis (PSC) is a progressive liver disorder of unknown cause.     Current evidence suggests that genes, the genetic material we inherit from our parents, in     combination with environmental factors, likely play an important role in the development of     PSC.      This study is being done to investigate whether genes make people more likely to develop PSC.     Discovery of these genes will help us to better understand how PSC developes and     subsequently, to apply new approaches for its prevention, diagnosis and treatment.   "
252592|NCT01162278|"     Patients that have had staging studies identifying them as AJCC stage IV with up to five     liver metastases will be considered for the study. About 60 patients will take part in this     study at UT southwestern, Parkland Health & Hospital System, and Methodist Richardson Cancer     Center. There are four dose cohorts for this study and each cohort will enroll a minimum of 7     to a maximum of 15 patients depending on tolerance of therapy. The treatment period will last     for approximately 1 day and the follow-up portion of the study will last 5 years.   "
252557|NCT01161823|"     After menopause the coronary artery disease (CAD) risk increases rapidly to an equivalent     risk of men with the same age. The rising incidence of CAD could be a subsequent decline of     endogenous estrogen blood levels after the menopause. Estrogen leads to vasodilation and     vasoprotection through an increase of Nitric Oxide (NO). NO deficiency results in endothelial     stiffness and dysfunction with a subsequent initiation of atherosclerosis. Menopausal status     is associated with an increase of the sympathetic nerve activity leading to hypertension,     increased heart rate and palpitations. Recent studies show an importance of vasoactive     substances (e.g. NO) in the physiology of hot flashes. Thus, hot flashes may be associated     with a decreased NO production and release. Additionally, it is well known that during and     after menopause women experience a change in sexual function (declined libido and increased     dyspareunia) due to decreasing estrogen blood levels. Recently, a new angiostatic parameter -     Endostatin (ENST) - has been shown to be involved in EC function. There is also evidence that     ENST levels increase during NO stimulation. Nebivolol, a ß-blocker of the third generation,     has been shown to release NO to a significant amount in the EC. It is safe and effective in     reducing blood pressure to the target level. However, there is no data of the effect of     Nebivolol on sexual function, on clinical symptoms (palpitations, increased heart rate and     hot flashes) and ENST in postmenopausal women. The present study investigates the effect of a     NO-releasing ß-blocker compared to a phytoestrogen therapy considering clinical signs of     menopause such as palpitations, hot flashes and sexual functioning in postmenopausal women.     Therefore, the use of a ß-blocker treatment is warranted. Further, this study tries to     elucidate the role of NO release in postmenopausal symptoms and may gain new insights in the     pathophysiology of hot flashes and increased sympathetic nerve activity. Thus, this trial     should explore an advantage of Nebivolol therapy in contrast to a phytoestrogen therapy.      Null hypothesis: Climacteric disorders as measured by the MRS-II in patients with a Nebivolol     therapy is not lower than in patients with phytoestrogen therapy. Alternative hypothesis:     Climacteric disorders in patients as measured by the MRS-II with a Nebivolol therapy is lower     than in patients with phytoestrogen therapy.   "
252558|NCT01161836|"     This is a Phase 1, multi-center, open-label study.      During Segment 1, patients are administered a single IV administration of [14C]-iniparib.      During Segment 2, patients are administered iniparib with or without additional chemotherapy.     Acceptable chemotherapy regimens is limited to those for which previous experience with     iniparib exists.   "
252586|NCT01162200|"     By using stereotactic body radiation therapy (SBRT) delivered with the Cyberknife system®,     the current protocol attempts to mimic or improve the excellent local control rates seen in     treatment of early stage breast cancer while attempting to increase convenience, limit     invasiveness, decrease toxicity, and improve cosmesis compared to other methods of radiation     treatment.   "
252559|NCT01161849|"     Laparotomy performed for both emergency of elective surgery may by complicated by     intrabdominal collection, anastomotic leakage, infarction and others. This conditions are     able to induce peritoneal inflammation. Inflamed peritoneum are able to produce excess of     lactate that the investigators can measure by collecting fluid from peritoneal drainage.      Drainage were left in abdomen for monitoring intrabdominal condition until the passage of     stool or flatus. Minimum drainage of serum is present daily also in uncomplicated post     operative period.      Serum lactate relates with increased systemic anaerobic metabolism such as SIRS, sepsis and     systemic hypoperfusion and it is easy to measure with a blood gas analysis.      The investigators hypothesized that the increases of peritoneal/ serum lactate ratio could be     an earlier, sensible, non-invasive, and economical marker of post surgical complications. The     decision whether and when to perform a relaparotomy in secondary peritonitis is largely     subjective and based on professional experience. Actually no existing scoring system aids in     this decision.      The aim of this study is to demonstrate that this ratio could be and useful tool for the     surgeon in this decisional process.   "
252560|NCT01161862|"     The investigators hypothesize that our closed-loop glucose-control system can provide BG     control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the     input signal to the controller.   "
252561|NCT01161875|"     Non invasive ventilation has been proposed to reduce the incidence of ventilatory dysfunction     following abdominal aortic surgery. However, the nasogastric tube reduces the airtightness of     the facial mask used to perform non invasive ventilation and induces air leaks. The use of a     helmet reduces air leaks, thus seems adequate to ensure patient-ventilator interface.     However, the high dead space related to helmet volume is responsible for asynchrony between     patient demand and ventilatory support delivery. The investigators hypothesized driving the     ventilator based on a neural signal (diaphragm electrical activity) would reduce     patient-ventilator asynchronies.   "
252562|NCT01161888|"     The purpose of this study is to determine if topical imiquimod is effective in the     pathological complete regression of lentigo maligna.   "
252563|NCT01161901|"     The ARDS has a clinical definition with criteria of the American-European Consensus     Conference (1994). This definition inconveniently applies to a lot of patients with acute     respiratory failure.      We know that there are 2 forms of ARDS morphology on CT scan : lobar attenuation (loss of     aeration with no concomitant excess in lung tissue) predominating in the lower lobes and non     lobar attenuation with diffuse and massive loss of aeration with excess lung tissue in all     the pulmonary parenchyma.      Today, plasmatic biomarkers are used as prognostic and diagnostic markers of ARDS. Some of     them are characteristics of the different damages in the ARDS (alveolar epithelium and     vascular endothelium lesions) : sRAGE, SP-D, PAI 1 and sICAM 1.      This study's hypothesis is that patients with ARDS criteria and lobar morphology on CT scan     present loss of aeration but no inflammatory pulmonary oedema, whereas patients with non     lobar morphology on CT scan present both characteristics.      The primary purpose of our protocol is to show that the patients who respond to ARDS criteria     and have a lobar morphology on CT scan do not have an elevation of the biomarkers specific to     the pulmonary aggression of ARDS.   "
252564|NCT01161914|"     The purpose of this study is to compare and evaluate the efficacy and safety of ISU302, an     investigational product, and Cerezyme®, comparator, for Type 1 Gaucher Disease patients   "
252565|NCT01161927|"     The purpose of this study is to compare experimental evaluation of relative bioavailabilities     in healthy, human subjects under non-fasting conditions.   "
252566|NCT01161940|"     This is a bioequivalence study of nizatidine Capsules 300 mg of Dr.Reddy's Laboratories     Limited under fasting conditions   "
252567|NCT01161953|"     Primary Biliary Cirrhosis (PBC) is a progressive liver disorder of unknown cause. Current     evidence suggests that genes, the genetic material we inherit from our parents, in     combination with environmental factors, likely play an important role in the development of     PBC.      This study is being done to investigate whether genes make people more likely to develop PBC.     Discovery of these proposed genes will help us better understand how PBC developes, and     subsequently, to apply new approaches for its prevention, diagnosis and treatment.   "
252568|NCT01161966|"     The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's     Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule     dose in fasted subjects.   "
252569|NCT01161979|"     The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's     Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule     dose in subjects fed a high standard fat meal.   "
252571|NCT01162005|"     To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the     investigators designed this prospective study. The investigators will enroll 100 children     with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated     with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level     between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies     will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs,     multivitamins and lipid-lowering agents.      Follow-up is every second week for the first 4 weeks, then monthly. After initiation of     tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.   "
252572|NCT01162018|"     The proposed study will recruit 60 women with breast cancer who finished undergoing treatment     who complain of persistent insomnia problems that began with onset of their cancer diagnosis.     The eligible women would be randomized and stratified by sleep problems to two arms:     (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study     (we anticipate about 20% attrition rate). The study interventions will begin after patients     completed their treatment. The placebo control for acupuncture will be a validated sham     acupuncture control Assessments will be made with daily diaries and with weekly     questionnaires. PSG data will be collected on the subsample of the population. Data will be     gathered via pencil-and-paper measures before, during, immediately following, one month     following the completion of treatment and six months after the conclusion of treatment. In     addition, actigraphy data (objective sleep continuity data) will be acquired prior to and     following treatment   "
252574|NCT01162044|"     PTSD is a common and distressing possible outcome following exposure to a traumatic event.     Recent studies show that memory processes may be central to the development of the disorder,     and interrupting the consolidation of traumatic memories may prevent the disorder from     developing. Specifically the use of a visual spatial task has been shown to reduce a key     characteristic of PTSD, intrusions, in non-clinical populations. This study aims to     administer a visual spatial task to recent trauma survivors in the Emergency Room, and     compare PTSD and symptoms development in these patients as compared to a control group who     did not carry out the task. The study hypothesizes that the task will result in less PTSD,     lower levels of intrusions, dissociation and pain.   "
252575|NCT01162057|"     The inner ear contains transporters that are responsible for maintaining a strict homeostatic     environment, necessary for transmission and transduction of sound waves. Hemodialysis affects     the body's composition including the aspects regulated by these transporters (pH, osmolarity,     Na, K). We wish to observe if hemodialysis affects hearing, and if so, by which parameters.   "
252576|NCT01162070|"     The Uveitis, the inflammation of the uvea, is a rare disease with an incidence of 52/100,000     inhabitants per year and a prevalence of 115 / 100,000 inhabitants per year.      The causes of uveitis are numerous and include infectious diseases, systemic and neurological     diseases, ophthalmic entities, neoplasia, and drug-related reactions. The etiological     diagnosis is important both for prognosis and therapeutics.      However, clinical evaluations to establish etiological diagnosis are not standardized. Some     authors suggest a minimalist examination, common to all kinds of uveitis. On the other hand,     others propose an evaluation guided by the anatomo-clinical type of uveitis.      We conducted a retrospective study to assess the contribution of complementary examinations     to etiological determination. In this study, we found that most patients benefited from a     wide paraclinical evaluation compared to what is usually described in the literature.     Complementary examinations were mostly systematic, without any clinical or ophthalmological     elements of orientation. This study highlighted the lack of contribution of some     examinations.      Using these results, and the literature analysis, we designed a diagnostic algorithm adapted     to the anatomo-clinical type of uveitis.      Moreover, we found that the average cost per patient was estimated at €290.51 with the     algorithm compared to €560.83 without it.      We would like to carry out a new study to estimate the efficiency as well as the     medico-economic impact of the use of a standardized strategy for the etiological diagnosis of     uveitis, compared with a free strategy.      Hypothesis:        -  The standardized strategy for the diagnostic of uveitis is at least as efficient as the          free one, and costs half as much.        -  The examinations prescribed, except for those from the standardized strategy, do not          contribute to etiological determination.   "
252577|NCT01162083|"     Cardiopulmonary exercise testing (CPET) is a safe, noninvasive investigation where a patient     walks on a treadmill or cycles whilst attached to an ECG and with a mask that measures the     air breathed in and out. It has numerous clinical uses, such as diagnosing the main cause in     patients with breathlessness, deciding on timing for heart transplantation and assessing     whether patients are safe for a general anaesthetic.      A patient's peak oxygen consumption, the maximum amount of oxygen taken up by the blood from     the lungs when breathing increases during exercise, is the main measurement taken from CPET.     It is low in heart disease and has been used to predict the risk of death and therefore plan     treatments for patients. However this is also low in numerous other diseases including lung     disease; reduced oxygen consumption in patients with two conditions may be wrongly thought to     be because of the heart leading to inappropriate action and distress to the patient.      Newer measurements of exercise capacity from the same exercise test are better at predicting     death in heart failure.      We propose that they are more specific for heart failure over other diseases, for example     lung disease, when compared with peak oxygen consumption, and are superior when a single best     test for heart failure is required.      This research aims to identify which measurement of exercise capacity is most specific for     heart failure. We will perform the test on many patients with different diseases, and before     and after procedures such as the implantation of special pacemakers, and heart valve     operations. This should lead to a more accepted use of this investigation and the more     appropriate identification of which patient should have which procedure.   "
252578|NCT01162096|"     Many patients with hematological malignancies (leukemia, lymphoma, multiple myeloma) cannot     undergo hematopoietic stem cell transplantation (HSCT) because they do not have a well     matched donor. HSCT from partially matched family donors (haploidentical HSCT) is an option     for most patients but has been associated with poor outcomes. This study was designed to test     whether using an exact amount of a donor's lymphocytes (white cells) and dividing the     transplant process into 2 steps, would increase overall survival by decreasing complications.     The therapy is reduced intensity so it is targeted, but not limited to, patients over the age     of 65 or those who have had previous transplants.   "
252579|NCT01162109|"     Sepsis is a clinical syndrome often caused by a bloodstream infection that results in a     common set of symptoms termed systemic inflammatory response syndrome (SIRS). Severe sepsis     (sepsis with organ failure) is the leading cause of death in critically ill patients in the     US. Most patients with severe sepsis need to be treated in the intensive care unit with     mechanical ventilation and intravenous antibiotics. Between 30 to 50% of all severe sepsis     patients die and quality of life in survivors is substantially reduced. New therapies are     needed to improve clinical outcomes in patients with sepsis.      A new area of interest in the treatment of critical illness is pharmaconutrition, in which     micronutrients (like zinc) are studied and administered to determine if they affect the     inflammatory response or immunologic processes in critical illness. The FDA does not regulate     micronutrients and does not require rigorous pharmacokinetic (the study of how a drug or     nutrient is metabolized in the body) testing so it is not clear how to dose micronutrients in     critically ill patients. It is also not clear if critically ill patients would metabolize     these micronutrients differently than healthy people and would need different dosing levels.     This is true of zinc, the focus of this research study.      Zinc is essential for normal immune function, oxidative stress response, and wound healing,     and its homeostasis is tightly regulated. Zinc deficiency occurs in >10% of Americans and     leads to loss of innate and adaptive immunity and increased susceptibility to infections. The     symptoms of zinc deficiency are similar to many of the symptoms of SIRS and there is strong     biologic rationale to suggest that the zinc deficiency seen in nearly all sepsis patients may     contribute to the development of sepsis syndrome and to the immunoparalysis common in     sepsis patients      This study has three specific aims, 1) to perform a phase I dose-finding study of intravenous     zinc in mechanically ventilated patients with severe sepsis; 2) to define the pharmacokinetic     of intravenous zinc in mechanically ventilated patients with severe sepsis compared to     healthy controls; and 3) to investigate the impact of zinc on inflammation, immunity, and     oxidant defense in patients with severe sepsis.      A total of 40 critically ill patients from the FAHC intensive care units and 15 healthy     controls will be enrolled in the study. The critically ill patient population will be divided     into 4 dosing groups of 10 subjects (7 randomized to zinc and 3 to saline placebo). Group 1     will receive 500mcg/kg IBW/day elemental zinc in divided doses every 8 hours. If the 50th     percentile of the normal plasma zinc range (110mcg/dL) has not been achieved in all patients     by 7 days and there are no safety concerns, sequential groups of patients will receive     increasing doses in 250mcg increments to the ceiling dose. Groups 2 through 4 will receive     750, 1000, and 1250mcg/kgIBW/day elemental zinc, respectively. Each participant will receive     the intravenous zinc or placebo for a total of 7 days unless they die or leave the ICU     earlier. Pharmacokinetic testing will be obtained from 40 of the critically ill subjects and     in 15 healthy controls. Additional blood will be drawn during the infusion protocol to     investigate the impact of zinc on inflammation, immunity, and oxidant defense.   "
252671|NCT01163305|"     The purpose of this study is to identify an early indicator of drug efficacy in patients with     advanced colorectal cancer - a prospective evaluation of circulating tumor cells,     positron-emission tomography scan and RECIST criteria.   "
252582|NCT01162148|"     Lung transplantation (LT) is now an established treatment option for patients with a wide     variety of end-stage lung diseases- aims to improve quality of life and survival. Pulmonary     rehabilitation (PR) is widely recognized as an important component of care of patients with     chronic obstructive pulmonary disease (COPD), it improves dyspnea, exercise tolerance,     quality of life, and reduces healthcare resource utilization.      The goal of pulmonary rehabilitation following lung transplantation is to enhance the     physiological and functional benefits resulting from surgery. Inspiratory muscle Training     (IMT) is defined as any intervention with the goal of training the inspiratory muscles. IMT     can improve inspiratory muscles strength, endurance and exercise capacity in adults with     COPD. IMT provides additional benefits to patients undergoing PR program and is worthwhile     even in patients who have already undergone a general exercise reconditioning (GER) program.     IMT will provide additional benefits (together or without) PR to patients following lung     transplantation. No formal guidelines exist regarding the optimal methods of exercise     training component of pulmonary rehabilitation for patients recovering from lung     transplantation. This study will evaluate the unique influence of IMT in Patients Following     Lung Transplantation.   "
252583|NCT01162161|"     In this mono-center prospective study, the impact of changes in the sphingolipid metabolism     in patients with pulmonary edema will be investigated.   "
252584|NCT01162174|"     The investigators hypothesize that acute consumption of Oligonol, a patented lychee fruit     extract (Amino Up Chemical Co.) particularly rich in low molecular weight flavanols, will     improve endothelial function, reduce platelet reactivity and increase circulating levels of     flavonoids after a single intake.   "
252587|NCT01162213|"     The investigators hypothesize that acute and short term consumption of a lychee fruit     extract, particularly rich in low molecular weight dietary flavanols, will improve vascular     function and reduce platelet reactivity.   "
252589|NCT01162239|"     The research is based on a chronic disorder model of cigarette smoking which suggests that     long-term treatment targeted to prevent relapse may be useful. Based on this model, the     investigators have developed a relapse prevention treatment to intervene on five areas     important in relapse prevention, including fluctuating motivation, depression, withdrawal,     weight gain, and social support. This treatment protocol has produced high long-term     abstinence rates when implemented in a clinical research setting. The current study will     evaluate the treatment model when implemented in a medical outpatient setting. This study     will test a series of hypotheses comparing the efficacy of the relapse prevention treatment     to other extended treatments. All participants will be assessed at baseline on demographics,     smoking behaviors, nicotine dependence, depression, alcohol and other drug history and     problems, mood disturbance, treatment support, stress, health status, and motivation for     change. Participants will be randomly assigned to one of four treatment conditions. All     participants will receive 12 weeks of combined pharmacological treatment (varenicline) and     behavioral treatment (five individual counseling sessions). Following this brief treatment,     participants will be randomly assigned to one of four treatment protocols        1. Monthly Brief Contact or        2. Extended Non-Specific Behavioral Treatment or        3. Extended Relapse Prevention Treatment or        4. Extended Relapse Prevention Treatment + availability of varenicline treatment. Each          extended treatment protocol is 40 weeks in duration. All participants will be assessed          at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.   "
252590|NCT01162252|"     The purpose of the study is to examine and compare the effects of the Mindfulness-Based     Stress Reduction (MBSR) program and the Living Well (LW) program on adults with psoriasis in     terms of how these programs may affect their psoriasis, immune function, physical and     emotional health, and well-being.   "
252591|NCT01162265|"     The objective of this study is to assess the efficacy of the two current TB (tuberculosis)     blood tests (Interferon Gamma Release Assays (IGRA)) compared with the standard skin test     (Mantoux Tuberculin Skin Test (TST)), for predicting active tuberculosis among those at     increased risk of TB. Those at increased risk are defined as either newly arrived immigrants     or people who have been in contact with TB cases. The study will also provide information on     the cost effectiveness of different testing strategies, such as the two step testing approach     recommended by NICE. The study is to be funded by the NIHR Health Technology Assessment     programme.      10,000 participants will be recruited from 12 hospitals and a network of GP surgeries in     London. All participants will have the skin test and blood taken for both assays. Disease     status of participants will then be followed up for an average of 24 months using the     national register of clinical reports, a phone call and the national microbiological     database. The risk of developing active disease is highest in the first two years after     exposure. During followup there will be no additional diagnostic procedures unless symptoms     occur, i.e. in line with current NICE policy. A sub group of patients, selected as a random     25% of participants, will have a repeat IGRA test shortly after the first test to investigate     whether the skin test affects the result of the blood test.   "
252593|NCT01162291|"     The purpose of this experimental pilot study is to assess a positive effect of higher     injection volumes of fluid (physiological sodium) in the elbow-flection-muscle (M. biceps     brachii) and elbow flexion and extension movements on fluid distribution in the muscle     tissue.   "
252594|NCT01162304|"     The investigators hypothesize that subjects will have greater pain relief when taking     IR-oxycodone compared with ER-oxycodone for several reasons. The ability to take a varying     amount of medication at six different points over the course of a day will allow patients to     take as much (or as little) medication as they need to control their pain. In addition, the     ability to vary the medication doses in this way will give them a greater sense of control,     which will also contribute to greater pain relief. Similarly, the investigators predict that     patients will show greater benefits with IR-oxycodone on the measures of physical and     emotional functioning. Because there is relatively little data on sleep apnea in chronic pain     patients (Webster et al., 2008), these assessments are exploratory and not hypothesis-based.     Finally, although it is typically thought that the abuse liability of IR-opioid medications     is greater than for ER-medications, the data on which this belief are based have not involved     systematic studies of patients with chronic pain; the assessments of abuse liability will     therefore also be exploratory.   "
252595|NCT01162317|"     Objective: To evaluate real acupuncture, as compare to sham acupuncture, in improving     persistent sleep difficulties in veterans with mild traumatic brain injury (mTBI) Design:     Randomized, blinded, sham-controlled clinical trial Setting: Outpatient clinic at a major VA     medical center in Southeast USA Participants: Sixty veterans aged 24-55 (mean 40) with     history of mTBI at least 3-month and beyond, suffering from sleep difficulties refractory to     regular care and sleep education, as indicated by a global Pittsburgh Sleep Quality Index     (PSQI) score of 14.25 + 3.23 pre-intervention (baseline). They were randomized into 2 groups,     real acupuncture versus sham acupuncture, and stratified by Post-traumatic stress disorder     (PTSD) diagnosed by PTSD CheckList - Military Version (PCL-M).      Intervention: Real or sham acupuncture with both standardized and individualized acupoints     selection. All subjects were informed that the treatments, if effective, may improve symptoms     such as pain, anxiety or depression other than sleep; real acupuncture may not be effective     in some individuals, and sham acupuncture may as well be effective by mind-body interactions.      Outcome Measures: Primary outcome measure was global PSQI score change after intervention as     compared to baseline. Secondary outcome measure was wrist-actigraphy sleep latency, sleep     efficiency, wake after sleep onset (WASO), and sleep duration. PTSD was analyzed as a     co-variant.   "
252596|NCT01162330|"     This study will look at the feasibility and acceptability of testing newborn babies who are     referred after their newborn hearing screen for an infection called congenital     Cytomegalovirus (cCMV). Around 1 in every 100 to 200 babies is born with this virus, and     although most remain well it causes 1 in 5 cases of childhood deafness. Knowing that a baby     is infected shortly after birth could have significant benefit since a treatment is now     available, but screening programs need to be feasible and acceptable. This study aims to     evaluate targeted screening for cCMV by taking samples (saliva and urine) from babies who do     not pass their newborn hearing screening. The investigators want to see if we can find a     quick, reliable and parentally acceptable way to screen babies who fail their hearing test     for this virus.   "
252597|NCT01162343|"     Delirium is an acute confusional state characterized by altered or fluctuating mental status,     inattention, and either disorganized thinking or an altered level of consciousness. This form     of organ dysfunction occurs in up to 10% of older emergency department (ED) patients and is     associated with worsening mortality, prolonged hospital length of stay, higher health care     costs, and accelerated functional and cognitive decline. Despite the negative consequences of     delirium, the majority of cases are unrecognized by emergency physicians because it is not     routinely screened for. In an effort to facilitate delirium screening, the investigators     sought to validate three brief delirium assessments in the ED setting.   "
252598|NCT01162356|"     Since the introduction of vitrectomy in 1971, this procedure has become the third most     frequently performed ophthalmic surgery. Approximately 225,000 vitrectomies are performed     annually in the United States and indications continue to expand. Known long-term     complications of vitrectomy are relatively few and include retinal detachment and cataract     formation. Although much has been written in the literature concerning acute rises in     intraocular pressure (IOP) in the immediate postoperative period, there is surprisingly     little information on long term IOP outcomes after vitrectomy. A recent report by Chang given     at the LXII (62) Edward Jackson Memorial Lecture hypothesized a causal relationship between     vitrectomy and open-angle glaucoma (OAG) via oxidative stress exacerbated by removal of the     crystalline lens. A second report by Luk and colleagues reported similar conclusions in a     modified cohort. Both studies, were retrospective in nature and did not perform baseline     evaluations to exclude pre-existing glaucoma. Furthermore neither study accounted for natural     history. Finally, our analysis has not reproduced similar results.      The primary purpose of this study is to analyze the full spectrum of optic nerve and macular     changes between vitrectomized study eyes and their non-vitrectomized fellow eyes to control     for natural history. Baseline evaluations will include examination by fellowship trained     retina and glaucoma specialists, fundus photography, autofluorescence, optical coherence     tomography (macula and optic nerve) and automated visual field testing. At 3 month then     annually for 5 years after vitrectomy surgery, the cohort will undergo similar evaluation.   "
252599|NCT01162369|"     Delirium is an acute confusional state characterized by fluctuating mental status,     inattention, and either disorganized thinking or an altered level of consciousness. This form     of organ dysfunction occurs in up to 50% of hospitalized patients and is associated with     worsening mortality, prolonged hospital length of stay, higher health care costs, and     accelerated functional and cognitive decline. Despite the negative consequences of delirium,     the majority of cases are unrecognized by hospital physicians because it is not routinely     screened for. In an effort to facilitate delirium screening, we sought to validate two brief     delirium assessments (<2 minutes) in the hospital setting.   "
252600|NCT01162382|"     This protocol, Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of     Major Depressive Disorder (MDD): A Functional Connectivity Magnetic Resonance Imaging (fcMRI)     Study, is an open-label pilot treatment study. The purpose of the present protocol is to     treat participants with a diagnosis of Major Depressive Disorder with 4 weeks of rTMS,     performing fcMRI and EEG studies prior to and following treatment to determine if treatment     response is related to changes in fcMRI and/or EEG results. The investigators hypothesize     that patients who respond to treatment will display changes in functional connectivity     patterns thought to be related to the occurrence of depressive symptoms.   "
252602|NCT01162408|"     Objective: To evaluate and compare the outcome predictive power of Acute Physiologic and     Chronic Health Evaluation (APACHE) Ⅳ、Ⅲ、Ⅱ scoring systems for intensive ill patients in an     independent medical intensive care unit (MICU), and explore the best time point when they can     most accurately predict outcome.      Design: Retrospective analysis of medical records. Methods and Materials: Collect data of     patients admitted between July 2010 and July 2013 to the medical intensive care unit of the     First Affiliated Hospital of Sun Yat-sen University in Guangzhou, China. Patients with an ICU     stay less than 4 hours and age less than 16 years were excluded. Calculate the APACHE Ⅳ、Ⅲ、Ⅱ     scores and corresponding predictive mortality risks in the first 24 hours of ICU admission     and the 3th, 5th, 7th, 14th, 21 th, 28th day or the day of transferred out of ICU or death.     The predictive power of each model was assessed through the ratio of observed death rates and     predictive death rates (Standardized mortality ratios, SMR), the calibration of observed and     predictive death rates and the discriminative ability between survivors and non-survivors.     Hosmer-Lemeshow test was employed for assessing the calibration and the discriminative     ability was assessed by the area under the receiver operating curve. Compare the predictive     power of the three models at different time points and explore the the best time point when     they can most accurately predict outcome.   "
252603|NCT01162421|"     A Canadian study to evaluate early use of adalimumab after methotrexate failure in early     rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces     joint damage in more participants when introduced earlier than in current practice.   "
252604|NCT01162434|"     Treatment resistant depression (TRD) is a major health concern, with 10% of patients with     major depressive disorder not responding to conventional treatments. The investigators     propose to compare the MRI (magnetic resonance imaging) brain scans of patients with TRD,     which were collected during surgical planning for deep brain stimulation, with age, sex,     handedness and education-matched healthy volunteer controls, to investigate anatomical     differences, specifically the volume of certain brain structures.   "
252605|NCT01162447|"     The investigators aim to compare the levels of bone morphogenetic protein-4 and -7 (BMP-4 and     7) in blood, follicular fluid and ovarian organ culture supernatant obtained from healthy     subjects and polycystic ovarian syndrome (PCOS) patients.   "
252606|NCT01162460|"     The purpose of this study is to investigate the efficacy and safety of eslicarbazepine     acetate (BIA 2-093) as monotherapy for patients with newly diagnosed partial-onset seizures.   "
252660|NCT01163162|"     The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney     functioning. The investigators hypothesize that the increase in serum creatinine observed in     recent paricalcitol trials is a function of reduced creatinine secretion and not an actual     reduction in kidney function. 16 patients will have kidney function measured via iothalamate     clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being     washed off the paricalcitol.   "
252607|NCT01162473|"     Background and Rationale      For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management     includes identification of the causative food and avoidance. Specifically, among young     children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%.     Given the prevalence of milk and the difficulty to avoid it in the diet, the investigators     aim to investigate the safety and efficacy of oral immunotherapy for cow's milk allergy.      Main Objective      The primary objective is to study the efficacy of milk oral immunotherapy.      Target Population      Children aged six to 17 years with a history of cow's milk allergy will be recruited from The     Children's Hospital of Philadelphia Allergy clinical offices for the investigators study.   "
252608|NCT01162486|"     The aim of this study is to evaluate (1) the safety and tolerability of escalating doses of     rifapentine (RPT) administered daily by oral; (2) the effect of increasing doses of RPT on     cytochrome P450 isoform 3A (CYP3A) enzyme metabolizing activity, using single-dose midazolam     (MDZ); and (3) the effect of increasing doses of RPT on autoinduction of RPT metabolism.   "
252609|NCT01162499|"     It has been proposed that the rapid gastric emptying of carbohydrate containing fluids into     the intestine causes hyperglycemia followed by reactive hypoglycemia. The investigators have     shown that glucagon-like peptide-1 (GLP-1) secretion in response to a glucose load is     increased in children with Post-prandial hypoglycemia (PPH). This is a proof of concept study     to investigate the causative role of GLP-1 in the pathophysiology of PPH after fundoplication     by evaluating the effects of GLP-1 receptor antagonism on metabolic variables after a mixed     meal.      Hypothesis: In children with post-prandial hypoglycemia after fundoplication, antagonism of     the GLP-1 receptor by exendin-(9-39) will elevate nadir blood glucose levels after a meal     challenge and prevent post-prandial hypoglycemia.   "
252610|NCT01162512|"     The purpose of this study is to examine the effectiveness of a telephone-based physical     activity (PA) intervention in obese adolescents attending a Health Weight Comprehensive     Clinic. Secondary aims focus on increasing the amount of change in obesity markers, namely     waist circumference and BMI z-scores. The investigators hypothesize the following: 1.The     telephone-based PA intervention will increase PA levels above the mail group; and 2. The     telephone-based PA intervention will provide changes in waist circumference and BMI z-scores     above the mail group.   "
252611|NCT01162525|"     Percutaneous tibial nerve stimulation is introduced as regular treatment option for fecal     urge continence at the Cantonal Hospital St. Gallen. During this introduction phase     efficiency und adverse events will be monitored in this observational study.   "
252612|NCT01162538|"     Pilot open label multicentric study   "
252613|NCT01162551|"     This is a phase 2 study looking at efficacy and toxicity of oral sirolimus in combination     with oral methotrexate in children with refractory/relapsed ALL or NHL.      Secondary objectives include characterizing the trough levels produced by administration of     oral sirolimus in children with refractory/relapsed ALL/NHL and to evaluate the effect of     sirolimus on intracellular targets related to mTOR inhibition.   "
252614|NCT01162564|"     This is a multi-center, observational study of incisional/ventral hernia repair with NG-TSM     laparoscopically. The study is not randomized and has a single treatment design assessing     NG-TSM intra-operatively, its ease of use and handling characteristics.   "
252615|NCT01162577|"     The purpose of the Weigh2Quit study was to test in a randomized trial, a weight concerns     intervention designed to reduce weight concerns that might impact cessation, increase     physical activity and adherence to tobacco treatment, increase confidence in quitting,     improve tobacco quit rates and decrease weight gain post-quit.   "
252616|NCT01162590|"     The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy     adults aged 18 to 45 years in China.   "
252617|NCT01162603|"     -  Main objective is to compare the ability of Latanoprost 0.005% preservative-added          ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution,          both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in          patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at          first diagnosis. First efficacy variable will be the difference between mean nocturnal          IOP values after three months of treatment: nocturnal IOP is defined as the mean value          between 2AM and 6AM measurements.        -  Secondary objectives will be the comparison between Latanoprost 0.005% and Tafluprost          0.0015% ophthalmic solution about:             -  Mean 24-hour IOP values after three months of treatment             -  IOP values at these time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour),               10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment   "
252618|NCT01162616|"     Iron deficiency and iron deficiency anemia are two major public health problems in developing     countries. In these countries, the use of monotonous plant-based diets, low in animal source     food but high in iron absorption inhibitors such as phytic acid or polyphenol, lead to poor     iron status or aggravate poor iron status caused by infections. In many West African     countries sorghum is a major source of energy, protein, vitamins and minerals especially for     the most poverty-stricken people. Some sorghum varieties are known to contain high levels of     polyphenols which have an inhibitory effect on iron absorption in humans. Polyphenols are a     huge group of plant metabolites with varying chemical structures. Depending on their     structure, the level of complex formation with iron in the intestine and thus the negative     effect on iron absorption is different.      Micronutrient deficiency can be combated by fortification of plant-based staples.     Fortification is a promising food-based approach which can be applied when other strategies     fail to provide adequate levels of the respective micronutrient in the diet. To fortify foods     with iron, a wide variety of different iron compounds have been used. The iron compound     sodium iron ethylenediaminetetraacetic (NaFeEDTA) overcomes the inhibitory effect of phytate     on human iron absorption. No information about the potential enhancing effect of NaFeEDTA in     presence of polyphenol is available.      The aims of the study are to investigate the effect of different sorghum polyphenol     concentrations on human iron absorption and to investigate if the negative impact of the     polyphenols can be overcome by using NaFeEDTA as iron compound. The study will include 32     apparently healthy young women which will consume sorghum porridges with different polyphenol     levels and sorghum porridges fortified with ferrous sulfate as compared to NaFeEDTA.     Furthermore test meals with added vitamin C or added laccase will be compared to a control     meal. Iron absorption will be determined by stable isotope technique.   "
252619|NCT01162629|"     Dental implants are a valid and reliable method to replace missing teeth. The major     requirement for their success is an adequate volume of bone into which they can be placed.     One widely used method to augment bone at the time of placing the implant is to use a bone     substitute rather than taking a block bone graft from the patient. Successful augmentation in     the vertical direction has often proved difficult, however, the investigators have developed     a technique to achieve this in the investigators patients using a synthetic bone substitute,     Osteon (Implantium, CE0120) in an attempt to avoid patients having to undergo another     unnecessary surgical procedure.   "
252621|NCT01162655|"     Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is     a prevalent and costly problem. This pilot study will compare the effectiveness of two brief     (6 week) psychological interventions delivered to residents of rural Manitoba using     Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants     in the Telehealth condition will report significantly greater improvements in sleep     parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity,     and daytime fatigue than those in the Internet condition and that b)participants in the     Telehealth condition will show better adherence to treatment and greater satisfaction with     treatment than those in the Internet condition.   "
252622|NCT01162668|"     Objective: to assess the health and economic outcomes (weight lost, change in control of     chronic diseases such as diabetes, quality of life, work productivity, health care cost, etc)     associated with bariatric (weight-loss) surgery for 200 severely obese patients who undergo     bariatric surgery as part of the Mississippi State Employees' Life and Health Insurance     Plan's Obesity Treatment Program (OTP).      2. Patient Characteristics: Inclusion criteria: Eligible bariatric surgical candidates who     are enrolled in the OTP (100 patients per year for 2 years). The Plan's criteria includes,     but is not limited to 1) enrollment in the plan for at least 12 consecutive months prior to     September 1, 2009; 2) completion of the HealthQuotient health risk assessment through the     Plan's wellness and health promotion program; 3) a Body Mass Index (BMI) of >40 kg/m2, or a     BMI >35 kg/m2 with two or more co-morbidities such as diabetes, hypertension, sleep apnea or     asthma; 4) two or more physician-supervised weight loss attempts within the last 24 months;     5) age 18 years or older; and 6) consent to provide personal and medical information to the     Plan. Prior to surgery, each site administers a psychiatric evaluation to ensure the patient     is psychologically stable for surgery. Exclusion criteria: any patient who does not meet     criteria above or who declines to participate. Surgeries will take place only at Certified     Bariatric Surgery Centers of Excellence (COE), of which, there are currently 3 in the state.     The 3 COEs exist with 4 outpatient medical offices (1 COE is composed of 2 independent     surgeon practices) Patients will be recruited at each site once they are approved by the OTP.      3. Design: prospective, observational, multi-center, longitudinal study of outcomes and     resource utilization associated with OTP. Estimates of obesity and comorbidities' impact will     be obtained from the outpatient medical office for the COEs. Medical charts, databases and     medical/pharmacy claims will be the source of information. Surveys on quality of life,     productivity, and patient satisfaction will be administered directly to patients. Database     claim information will be obtained in future and is not a part of current IRB application.      4: Procedures: After obtaining informed consent, patients will be administered surveys at     baseline, as well as at follow-up visits. Additional data will be obtained via patient     charts, databases, and medical/pharmacy claims.   "
252623|NCT01162681|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of three     different doses of A-623 administered in addition to standard therapy in subjects with active     SLE disease   "
252624|NCT01162694|"     Management of type 2 diabetes is an ongoing challenge for patients and their doctors. In     order to prevent short and long term complications, patients need to monitor and control     their blood sugar levels. In addition, they may need to have an ongoing communication with     their doctor in order to modify treatment. In this study the investigators wish to compare     two systems of monitoring and communication of blood sugar levels. The first is the use of     continuous glucose monitoring system and the second is the use of an Internet-based glucose     monitoring system. The investigators want to compare their effect and/or benefits.   "
252625|NCT01162707|"     The purpose of the trial is to evaluate the wireless monitoring of pulmonary artery pressure     using the CardioMEMS HF Pressure Measurement System in adult subjects with NYHA Class III     Heart Failure.   "
252626|NCT01162720|"     To establish whether a short duration of tourniquet application (from cement fixation to     cement setting)is associated with better patient functional outcomes compared to a long     duration of tourniquet application (from surgical incision to cement setting).      It is hypothesised that tourniquet application during cement fixation only (approximately of     20-30 min duration) will be associated with less pain and impairment than a longer tourniquet     application (> 45 minutes).   "
252627|NCT01162733|"     In 2008, our ED administered an average of 245 doses of vancomycin per month. Currently there     is no consistency in the ED practice in regards to vancomycin dosing. In 2009, the IDSA put     forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more     rapidly. It has been hypothesized that if therapeutic levels are reached more rapidly then     patients will in turn have better clinical outcomes and that the development of resistant     organisms will be decreased. Methicillin resistant Staphylococcus aureus (MRSA) has emerged     as one of the most deadly pathogens that are currently plaguing our patient population.     Vancomycin is one of only a few antibiotics that are effective for treating MRSA. It is     imperative that the ED physicians consistently and correctly dose vancomycin in order to give     the patients the best chance to fight infection while helping to prevent further resistance     in this already highly resistant organism. It is believed this study will reveal that the new     dosing recommendations by the IDSA will lead to the achievement of therapeutic levels more     rapidly. This information will in turn help to convince ED physicians that a change in     current clinical practice is warranted and ultimately lead to better clinically outcomes for     the patients.   "
252628|NCT01162746|"     Age-related macular degeneration (AMD) is by far the most common disorder in the group of     irreversible causes of visual disability. AMD leads to dysfunction and loss of photoreceptors     in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease     process and severely compromises the highly developed functions of the macula, such as     perception of details, central fixation, color vision, and reading ability. AMD-related     visual impairment is associated with a loss of autonomy and quality of life. Current     therapeutic approaches target vascular endothelial growth factor (VEGF), which has been     identified as a main cytokine in the pathogenesis of nAMD. Ranibizumab, the fab-fragment of     an antibody targeting VEGF is approved for the treatment of nAMD applied intravitreally in     monthly intervals until the disease activity is stopped. However, a significant proportion of     patients with nAMD suffer from persistent or recurring disease with the need of continuous     anti-VEGF therapy over months and years, often leading to irreversible changes in the     photoreceptor layer and the pigment epithelium.      Recent studies regarding the treatment of nAMD utilized different forms of therapies,     combining photodynamic therapy with verteporfin (PDT) and ranibizumab, as well as therapeutic     regimen containing steroids. Even though these studies did not provide evidence that     combination therapies are superior to ranibizumab monotherapy, studies were only conducted     with patients with previously untreated nAMD. Therefore, currently there is no alternative     therapeutic approach for patients with recurrent or persistent form of nAMD after multiple     treatments with ranibizumab monotherapy.      The purpose of this study is to assess the treatment effect of reduced fluence PDT and     intravitreal ranibizumab versus intravitreal dexamethasone and ranibizumab versus     intravitreal ranibizumab monotherapy in patients with persistent or recurrent choroidal     neovascularization (CNV) due to AMD.      The investigators hypothesis is that these findings will offer new insights in the management     of persistent or recurrent CNV secondary to AMD.   "
252738|NCT01163942|"     The purpose of this study is to examine the effect of G-CSF on disease free survival and     overall survival in aplastic anaemia patients who also receive ATG and Cyclosporin A.   "
252739|NCT01163955|"     To determine if sitting in a chair or sitting on the floor lends itself to better posture     while playing video games.   "
252629|NCT01162759|"     The goal of this project is to improve hypertension control at Kaiser Permanente Colorado     (KPCO) by implementing a population-based multi-factorial intervention that uses home BP     monitors that can download BP readings to KPCO's health records via internet, interactive     voice response (IVR) technology, and multidisciplinary care team. Participants will be     randomized to either the home blood pressure monitoring group receiving the multi-factorial     intervention or the usual care group who will be receiving Kaiser standard of care. We will     determine the proportion of patients in each group who achieve their target BP goals at 6     months, according to national clinical practice guidelines. The study hypothesis is that a     higher proportion of patients with uncontrolled hypertension in the home blood pressure     monitoring (HBPM) group will achieve their target blood pressure compared to those in the     usual care (UC) group.   "
252630|NCT01162772|"     Cardiovascular events are the most common cause for death in type 2 diabetes mellitus (T2DM)     patients. Male diabetics have a 2 to 3 fold risk for cardiovascular disease (CVD) whereas     female diabetes patients have a 3 to 7 fold risk for suffering from a CVD.      Endothelial dysfunction (ED) plays a central role in the development of atherosclerotic     lesions. Moreover, ED represents an important diagnostic and prognostic parameter to estimate     the cardiovascular risk in an early state. Experimental and clinical studies indicate that     T2DM is closely associated with ED, which may be the consequence of a reduced bioactivity of     nitric oxide (NO).      The success of diabetes therapy is monitored by the long-term parameter HbA1c. However, only     two thirds of all patients with T2DM in the USA and Europe find themselves in the recommended     HbA1c span (6.5-7.0 %). Consequently, oral anti-diabetic medication needs permanent     adjustment and intensification in order to delaying the progress of T2DM.      Recently, two peptide hormones with insulinotropic effects were identified. These hormones,     glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are     secreted by the gastrointestinal tract after exposure to glucose in nutrition. Physiological     effects are increased insulin secretion, inhibition of glucagon secretion and reduction of     body weight. Furthermore, these incretins are reduced in patients with impaired glucose     tolerance. Thus, the therapeutic approach lies within the elevation of GLP-1 and GIP by     preventing their degradation through the enzyme DPP-4 (dipeptidylpeptidase 4).      Thereby, the so-called gliptins inhibit the DPP-4 enzymes. Best results in HbA1c reduction     were achieved when gliptins were combined with metformin, glimepiride or pioglitazone.      In this study, patients with T2DM, who are taking metformin as first line medication but do     not achieve a HbA1c below 7.0 %, will routinely get an add-on therapy with gliptins     (Vildagliptin or Sitagliptin) as second line therapy according to the guidelines of the     Österreichische Diabetes Gesellschaft (ÖDG) prescribed by a medical doctor not involved in     this study. This medication is a ÖDG standard therapy in T2DM, which patients receive anyway     despite this study. Therefore, the therapy with gliptins is not a study medication and is not     influenced by the study either. Only patients, who will meet the inclusion criteria of the     study and voluntarily participate in the study, will be investigated.   "
252631|NCT01162785|"     The goal of this part (Part 1) of this clinical research study is to learn about the safety     of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients     with bladder cancer that has come back. The goal of Part 2 of this study is to learn about     the safety of giving 2 more doses of SCH 72105 directly into the bladder of Part 1     participants who had no sign of bladder cancer after Week 12. The level of effectiveness of     SCH 72105 will also be studied by measuring the interferon (IFN) levels in the urine.   "
252632|NCT01162798|"     The purpose of this study is to assess growth of preterm infants fed a test formula compared     to a standard formula up to the first 4 months of corrected gestational age.   "
252633|NCT01162811|"     The purpose of this study is to test the efficacy of visualization and relaxation exercises     together with a structured behavioural attention from nurses during ablation of atrial     fibrillation.      The study will test the following hypothesis which is also aim for intervention:      Relaxation and visualization performed in patients during ablation of atrial fibrillation     combined with structured attention behaviour from the nurse reduces the patient's experience     of pain and anxiety - and secondary reduces the consumption of painkillers and the number of     episodes of adverse outcome that requires extra attention from staff.      The survey is conducted as a controlled trial with a control group and an intervention group.   "
252672|NCT01163318|"     The purpose of this study was to collect data on the incidence of adverse drug reactions,     infections and malignant tumors, as well as factors that might affect the safety and     effectiveness of Humira® (adalimumab; 40mg/0.8 mL) in Japanese participants who received the     drug for the treatment of rheumatoid arthritis.   "
252634|NCT01162824|"     The investigators are hoping to discover the cause of chest pain in patients with a normal     coronary arteriogram. For patients with chest pain coronary angiography is the standard     method by which the blood vessels of the heart can be visualized and any narrowing can be     assessed. In some cases the investigators find totally normal coronary blood vessels or only     minor disease. Such a finding is associated with an excellent long term prognosis. However,     as a large proportion of patients with normal coronary arteries or mild coronary narrowings     often continue to experience recurrent chest pains the investigators are interested in     understanding the mechanisms responsible for this. The investigators hypothesise that in many     cases, coronary artery spasms are responsible for the recurrent chest pains. These spasms     usually respond to treatment with drugs known as vasodilators. The acetylcholine test     (ACH-test) has been recommended by the European Society of Cardiology and the American     College of Cardiology as a diagnostic test. This test can reveal whether the coronary blood     vessels have a tendency to go into spasm. The investigators plan in this study to carry out     the test in patients who have chest pains suggestive of coronary narrowings but are found to     have normal or only mildly narrowed coronary arteries on angiography. A positive test     -indicating a tendency for spasm- may help guiding therapy with vasodilators, which are often     very effective to prevent coronary spasms. The investigators would also like to take blood     samples during the test (before and after) from every patient to measure blood markers and     see if there is a relation between these markers and the result of the ACH-test.   "
252635|NCT01162837|"     This study will determine if the use of the BEAM device reduces the signs and symptoms of     mild-to-moderate acne.   "
252636|NCT01162850|"     Primary Objective: To determine whether there is improvement in the melasma of participants     taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium     Leucotomos is well tolerated in study subjects with melasma.      To determine whether treatment with Polypodium Leucotomos improves the health-related quality     of life.   "
252740|NCT01163968|"     The purpose of this study is to examine the use of a home-based program to improve weight     reduction after percutaneous coronary intervention (PCI) (either a cardiac stent or     angioplasty procedure).   "
252741|NCT01163981|"     The investigators suspect that using ultrasound to guide insertion of needles for dialysis     patients will make this process quicker and more accurate, thus reducing complications and     reducing discomfort for patients.   "
252637|NCT01162863|"     Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or     discomfort in association with altered bowel habit. IBS is further subcategorized as three     types according to the predominant bowel movement pattern: IBS with constipation (IBS-C), IBS     with diarrhea (IBS-D), and mixed-IBS (IBS-M). The exact causes of IBS remain incompletely     understood, but proposed mechanisms include abnormal motility, visceral hypersensitivity,     abnormal brain-gut interactions, psychological distress, and altered GI tract motility.      Lubiprostone, a novel drug that works by activating the colonic Chloride channel type     2(ClC-2), has been approved for use in patients with chronic idiopathic constipation and     recently approved for the treatment of IBS-C in women aged 18 and older. By activating the     ClC-2 chloride channel in the colon, lubiprostone allows more fluid secretion into the     intestinal lumen which leads to softer stool consistency. In phase III clinical trials,     patients with IBS-C receiving lubiprostone have reported improvements in many symptoms such     as abdominal pain and constipation. However, there is limited physiologic data to explain how     exactly lubiprostone improves IBS-C symptoms.      The Smartpill is a novel non-digestible capsule that is capable of measuring intraluminal pH,     pressure, and temperature in the gastrointestinal (GI) tract. Smartpill has been shown to     accurately measure whole gut as well as regional (i.e. stomach, small bowel, colon) transit     time.      The primary aim of this study is to determine the effects of lubiprostone on whole GI tract     transit, colonic transit, motility, and intraluminal pH in patients with IBS-C through     evaluation with the Smartpill. The investigators propose to study the effect of lubiprostone     vs. placebo on these parameters, and secondarily to evaluate changes in these parameters with     differing doses of lubiprostone.      The investigators hypothesize that lubiprostone will increase whole GI and colonic transit     compared to placebo in patient with IBS. the investigators do not expect a change in     intraluminal pH with lubiprostone compared to placebo.   "
252638|NCT01162876|"     The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of     saxagliptin administered before breakfast for 14 consecutive days in patients with type 2     diabetes mellitus.   "
252639|NCT01162889|"     This is a first in human study to determine the safety and tolerability of the drug after     single doses. Nine doses of increasing strength will be injected or infused (given into a     vein) to 9 different groups of people. One third of the participants will be given an     injection or infusion of placebo (sugar water). All participants will be healthy people.   "
252640|NCT01162902|"     Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta     blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery     disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more     important than relieving angina symptom. Dysfunction of microvessel is one of the most     important factor in patients with coronary artery disease. Recently, we developed the new     non-invasive method of evaluating the microvessel in fundus. With this methods, we will     compare the effect of each drug (beta blocker, CCB, ARB).   "
252641|NCT01162915|"     This study is based on preclinical (animal) studies showing that infusing bone marrow-derived     mesenchymal stem cells into the spinal fluid may contribute to improving neurologic function     in animal models with spinal cord injuries. Bone marrow (BM) contains several types of stem     cells that can produce functional cells. This includes cells that could help the healing     process of damaged neurologic tissue.      The primary objective of this study is to see if the injection of these cells, obtained from     your own bone marrow, is safe. A secondary objective is to evaluate if the treatment can     provide functional improvements (neuromuscular control and sensation) in the affected areas.   "
252642|NCT01162928|"     The primary objective is to assess the effect of fish oil-enriched enteral and parenteral     nutrition on blood oxygenation in critically ill patients.   "
252643|NCT01162941|"     Proportion who would avoid splenectomy at 6 months of follow up   "
252644|NCT01162954|"     This is a double-blind, randomized, placebo-controlled, 4-period, cross-over clinical trial.     The study is designed to evaluate the safety and local tolerability of DA-6034 upon single     and repeated-dose topical application to the both eyes in healthy volunteers.   "
252645|NCT01162967|"     The investigators propose the evaluation of posaconazole and benznidazole in humans for the     treatment of Chagas disease chronical infection. Exploratory trial of posaconazole     antiparasitic activity against Trypanosoma cruzi.   "
252646|NCT01162980|"     ACE inhibitors have been studied extensively in the treatment of heart failure and have been     shown to be beneficial in all its stages. Studies with the use of angiotensin receptor     blockers (ARBs) in chronic heart failure have not shown equivalent results. Many patients are     on an ARB for a variety of reasons. Some of these may have had cough as a symptom of heart     failure and not due to medication side effect. According to guidelines, angiotensin     converting enzyme inhibitors (ACEi) are still first-line therapy in the treatment of heart     failure. As ACEi have been extensively studied showing improvement in morbidity and mortality     all patients should be on this treatment unless absolutely contraindicated.   "
252647|NCT01162993|"     Rationale: Diabetic neuropathy is one of the most common complications of Diabetes Mellitus     (DM). Pain is a common symptom of diabetic neuropathy, affecting 11-34% of patients suffering     form DM. The burden of disease of painful diabetic polyneuropathy (PDP) is high for both the     patient and society, due to significant pain levels, frequent co-morbidity, polypharmacy and     significant health resource use. Spinal cord stimulation (SCS) has been used for over 30     years to treat neuropathic pain. Several small clinical studies have shown a beneficial     effect of SCS on pain in PDP.      Objective: The primary objective of this study is to investigate whether SCS leads to     clinically relevant (≥50%) pain relief in patients with moderate-to-severe PDP in the lower     limbs after 6 months of treatment.      Secondary objectives to investigate 1) the effect of SCS on health related quality of life in     PDP; 2) the effect of SCS on the quality of sleep in PDP; 3) the effect of SCS on mood in     PDP; 4) the effect of SCS on blood glucose control in PDP; 5) the effect of SCS on large and     small nerve fibre functions in PDP; 6) identifying predictive factors for success of SCS     treatment of PDP; after 6 months 7) the effect of SCS on small fibre loss and regeneration in     PDP; and 8) costs, cost-utility and cost-effectiveness after 12 months of treatment.      Study design: the study is a multi centre randomized controlled trial. Study population:     Patients suffering from moderate-to-severe PDP in the lower limbs due to diabetes mellitus     type 1 or type 2 as diagnosed by clinical symptoms (glove and stocking distribution).      Intervention: patients assigned to group 1 will receive spinal cord stimulation (SCS) and/or     best (drug) treatment as possible, patients assigned to group 2 will receive best (drug)     treatment as possible.      Main study parameters/endpoints: The main study parameter will be the mean pain intensity     and/or maximal pain intensity during daytime and/or during night time as measured on a     weighted NRS and/or a PGIC for pain and sleep measured on a 7-point Likert scale, after 6     months of treatment.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: SCS related risks include: lead migration (14%), lead breakage (7%), implanted     pulse generator migration (1%), loss of therapeutic effect, lost or unpleasant paresthesias     (12%), infection or wound breakdown (10%), Pain at IPG incision site (12%), IPG pocket fluid     collection (5%). Treatment-as-usual related risks are related to the medication used and do     not increase due to participation in this study.   "
252648|NCT01163006|"     Controlling the glycemic impact of foodstuffs (by reducing the glycemic load of the diet by     using soluble dietary fibres) may reduce the glycemic or insulinemic response. This may in     turn result in a reduced inhibition of postprandial fat oxidation rate and a lower plasma     triacylglycerol concentration A higher postprandial fat oxidation may result in less lipid     accumulation in non-adipose tissue thereby improving insulin sensitivity and the metabolic     profile in the longer term.   "
252742|NCT01163994|"     The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus     15-day doxycycline treatment in patients with multiple erythema migrans.   "
252649|NCT01163019|"     Background: Chest pain (CP) and suspected heart attack is the second most frequent complaint     among patients presenting to the emergency department (ED). Present workup involves     in-hospital observation for 6 - 48 hours and requires significant resources including imaging     tests, some of which are invasive and involve radiation and radio-contrast agents, which can     be toxic to the kidney.      CP can result from impaired blood supply to the heart muscle, which may result in impaired     contraction of the heart that persists for several days. Bedside echocardiography with     semi-automated speckle tracking strain analysis (2D strain) is a novel promising noninvasive     tool for the evaluation of heart muscle contraction. 2D strain can be useful for evaluating     patients with CP, since it can accurately detect minor impairment in heart muscle contraction     that can identify patients with coronary artery disease (CAD) and impending heart attack     (coronary arteries are the arteries supplying blood to the heart muscle).      Working hypothesis and aims: The investigators hypothesize that a bedside echo study with     normal 2D strain may allow quick and safe ruling out of a heart attack and significant CAD     disease as the cause of CP.      The main aim of the study is to validate the investigators preliminary findings in a large     number of patients in order to establish whether a normal 2D strain can safely rule out a     heart attack or life threatening CAD.      Methods: In a large multi-center study 1200 patients presenting to the ED with acute CP of an     unclear cause will undergo echocardiography as close as possible to presentation and not more     than 24 hours from cessation of pain. Patients will undergo standard workup by the ED     physicians. Standard echocardiographic findings, but not the 2D strain analysis, will be made     available to the attending physician. Data from discharge letters, ECGs, blood tests, stress     tests, nuclear imaging, heart CT and heart catheterization will be collected. A 6-month     follow-up telephone interview will be performed to collect data on survival, heart attacks,     re-hospitalization and revascularization (opening heart vessels blockages). 2D strain     analysis will be performed off-line in a central laboratory to evaluate the ability of 2D     strain to distinguish between patients with CP from heart disease and patients without life     threatening heart disease that can be early released home safely.      Expected results: The investigators expect, based on the investigators previous experience,     that patients with normal 2D strain will have a very low probability of a heart attack and     significant CAD. The investigators further expect these patients to have an excellent 6-month     prognosis. This will allow their early and cost-effective discharge.      Importance and Probable implications to Medicine: Reduction in ED patient load and a decrease     in unnecessary hospitalizations for CP. Cost and resource savings and elimination of     unnecessary imaging studies, some of which are invasive or involve radiation and contrast     agents.   "
252650|NCT01163032|"     The purpose of this study is to evaluate the efficacy and safety of a six month double-mask     treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake     Disorder   "
252651|NCT01163045|"     The purpose of this study is to evaluate if intraoperative neuromonitoring associated to     neurostimulation of recurrent laryngeal nerve reduce the rate of recurrent laryngeal palsy     respect to neurostimulation alone.   "
252652|NCT01163058|"     Aim of the present retrospective study is to evaluate molecular factors of primary resistance     to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The     investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and     Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor     (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and,     secondly, the investigators correlate molecular markers with clinical features and outcome in     terms of response rate, progression free survival and overall survival.   "
252653|NCT01163071|"     The purpose of this study is to determine the MTD and/or RP2D of ABI-011 when administered by     IV on Day 1, Day 8 and Day 15 with one week of rest for patients with advanced solid tumor     malignancies and lymphomas.   "
252654|NCT01163084|"     This randomized phase I/II trial studies giving leuprolide acetate or goserelin acetate     together with or without vismodegib followed by surgery to see how well they work in treating     patients with prostate cancer that has spread from where it started to nearby tissue or lymph     nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as     leuprolide acetate or goserelin acetate, may lessen the amount of androgens made by the body.     Vismodegib may slow the growth of tumor cells. Giving antihormone therapy together with     vismodegib may be an effective treatment for prostate cancer.   "
252655|NCT01163097|"     The purpose of this study is to evaluate the effect of a continuous intravenous infusion of     unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult     subjects.   "
252656|NCT01163110|"     The purpose of this study is to measure the therapeutic potential of Escherichia coli (E.     coli) and yeast ribosomal Ribonucleic acid (RNA) fragments to maintain the production of     platelets in patients undergoing cytotoxic therapy for cancer.   "
252673|NCT01163331|"     This study will compare group singing to group speech therapy without singing. You may be     eligible for this study if you have been diagnosed with PD for one year or more and you have     a quiet voice or difficulty being understood.   "
252674|NCT01163344|"     The purpose of this study is to gather data to see if so-called enriched forms of exercise     programs such as dance is more effective in improving balance and quality of life in patients     with idiopathic Parkinson's disease than regular exercise programs that are currently     provided by physical therapists.   "
253569|NCT01174472|"     The aim of the study is to compare the feasibility and the effectiveness, by means of     immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon     angioplasty for the treatment of failing dialysis access.   "
252657|NCT01163123|"     Japanese encephalitis (JE) is one of important zoonotic infectious diseases in Taiwan. JE     caused by Japanese encephalitis virus (JEV) which transmitted by Culex tritaeniorhynchus and     used swine as amplifying host. Infections leading to overt encephalitis are estimated to be 1     in 1000 cases. Among JE confirmed cases, approximately 25 percent of cases die and 50 percent     of the survivals develop permanent neurologic and/or psychiatric sequelae. JEV circulated in     Taiwan are belonged to genotype III and the vaccine strain selected from same genotype.     Genotype I JEV was first detected in northern Taiwan in 2008 by CDC, and the same genotype     JEV were detected in mosquito collected in central Taiwan by our group. In order to study the     genotypic shift of JEV in Taiwan areas, and the effects of the replacement of genotype on     vaccine, we will conduct the JEV seroepidemiology in Hualien county which was the highest     incidence of JEV in Taiwan. The aims of this study were: (1) study the circulating of     genotype I JEV in Hualien county; (2) determine the virulence of genotype I JEV in human; (3)     differential diagnosis of JEV genotype I or III infection among confirmed cases; (4) measure     the cross neutralizing activity, after immunized with genotype III JEV vaccine, against     genotype I JEV; (5) determine the age-specific seroprevalence of JEV antibody; (6) estimate     the annual risk of infection for JEV.   "
252658|NCT01163136|"     This study will look at a cohort of parents whose children are confronting life-threatening     illnesses in intensive care, palliative care, and complex care settings, to test whether     parents with higher levels of hopeful patterns of thinking are subsequently more likely a) to     change the level of care order status of their child (as an important and demonstrable     example of adapting goals); b) to reprioritize goals for the child when they are reassessed     regarding goals ; and c) to report a higher degree of achieving self-defined 'good parent'     attributes.   "
252661|NCT01163175|"     The majority of trans fatty acids consumed by the general population is derived from products     that have been formulated using significant amount of hydrogenated vegetable oil (the     so-called industrial trans fat). Fat from ruminants also contains small amounts of trans     fatty acid, which contribute, although to a smaller extent, to the total dietary intake of     trans fatty acids in the general population. The negative impact of consuming industrial     trans fat on health, particularly on cardiovascular disease, is being increasingly     recognized. Based on data available to date, it is currently not possible to conclude if     effects of ruminants and industrial trans fatty acid on cardiovascular risk are different.     There is therefore an urgent need for a study that compares the impact of naturally occurring     trans fatty acids such as those from dairy products and of trans fatty acids form industrial     sources on cardiovascular risk factors as well as their mechanisms of action.      The general objective of the study is to investigate the impact of naturally occurring trans     fatty acids from dairy products (mainly vaccenic acid) on plasma cholesterol levels and other     risk factors for cardiovascular disease.   "
252662|NCT01163188|"     The major aim is the follow-up of the highest risk group (< 32 weeks gestation/ < 1500     birthweight) and their controls of the Bavarian Longitudinal Study (BLS) at the age of 24-27     years. The focus will be the identification of risk, protective and resiliency factors for     cognitive and behavioural development and quality of life.      MRIs of the central nervous system will be conducted to examine aberrant activation patterns     during the attention network task in stratified subgroups. Data driven MRI methods will be     evaluated in relation to clinical, behavioural and developmental parameters.   "
252663|NCT01163201|"     This is a unique dose-escalation trial that will titrate doses of umbilical cord blood (UCB)     Treg and CD3+ Teff cells with the goal of infusing as many CD3+ Teff cells as possible     without conferring grade II-IV acute graft-versus-host disease (GVHD).      In this study, the investigators propose to add UCB Treg and UCB CD3+ Teff cells to the two     TCD UCB donor units with the goal of transplanting as many CD3+ Teff cells as possible     without reintroducing risk of acute GVHD. The investigators hypothesize that Treg will permit     the reintroduction of CD3+ Teff cells that will provide a bridge while awaiting HSC T cell     recovery long term. The co-infusion of Treg will prevent GVHD without the need for prolonged     pharmacologic immunosuppression.   "
252664|NCT01163214|"     The purpose of this study is to compare two methods of postoperative pain management in     patients undergoing total knee replacement.   "
252665|NCT01163227|"     This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients     with chronic stable schizophrenia.   "
252666|NCT01163240|"     The purpose of this study is to collect epidemiological data in children and adolescents with     chronic hepatitis B(CHB), in particular data on the prevalence of HBeAg positive disease with     associated ALT levels , active HBeAg negative disease and decompensated CHB in the pediatric     population. Family history and history of HBV transmission is essential to assess the course     of the disease and can be used to determine the best mode of treatment This information will     be used to assist with the feasibility and design of studies for the Novartis clinical     pediatric development program, as the current epidemiology of ediatric CHB is not accurately     known in Western countries or the rest of the world making pediatric studies difficult to     plan and conduct. This study forms part of the Novartis Pediatric Investigational Plan, a     post marketing approval commitment to the EMEA Pediatric Committee.   "
252667|NCT01163253|"     The main objective of this study is to evaluate the long-term safety of CP-690,550 in     patients being treated for moderate to severe chronic plaque psoriasis. This is an open label     extension study available to patients who participated in one of the qualifying studies with     CP-690,550 providing entry criteria is met.   "
252675|NCT01163357|"     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Giving chemotherapy drugs, such as fludarabine phosphate and     melphalan, and total marrow irradiation before a donor peripheral blood stem cell transplant     helps stop the growth of cancer cells and helps stop the patient's immune system from     rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into     the patient they may help the patient's bone marrow make stem cells, red blood cells, white     blood cells, and platelets.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     given together with fludarabine phosphate and melphalan with or without total marrow     irradiation in treating patients undergoing donor peripheral blood stem cell transplant for     high-risk stage I or II multiple myeloma.   "
252676|NCT01163370|"     Resistance training as well as creatine supplementation may increase bone mass. Therefore,     the investigators speculate that resistance training combined with creatine supplementation     would promote additive benefits on bone mass in elderly women with osteopenia and     osteoporosis.   "
252677|NCT01163383|"     Metaiodobenzylguanidine (MIBG) is a substance that is taken up by neuroblastoma or     pheochromocytoma/paraganglioma tumor cells. MIBG is combined with radioactive iodine (131 I)     in the laboratory to form a radioactive compound 131 I-MIBG. This radioactive compound     delivers radiation specifically to the cancer cells and causes them to die.      The purpose of this research protocol is to provides a mechanism to deliver MIBG therapy when     clinically indicated, but also to provide a mechanism to continue to collect efficacy and     toxicity data that will be provided.   "
252678|NCT01163396|"     This is a single-arm, open-label, multicentre phase II study evaluating the safety and     efficacy of the combination of the G.O.N.O. FOLFOXIRI regimen with bevacizumab as first-line     treatment of metastatic colorectal cancer.   "
252679|NCT01163409|"     Set of real acupuncture treatment and supervised aerobic exercise have better efficacy in     pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised     aerobic exercise, as well as treatment versus combination with aerobic exercise and     resistance exercise the major muscle groups, both supervised versus group control, who just     get guidance for physical activity.   "
252680|NCT01163422|"     The purpose of this study is to determine whether cardiac resynchronization therapy with the     use of an implanted electronic pacemaker reduces morbidity associated with chronic     thromboembolic pulmonary hypertension   "
252743|NCT01164007|"     This study will assess the preliminary anti-tumor activity and safety profile of a     combination of bevacizumab and dacarbazine in participants with unresectable/metastatic     melanoma not previously treated with chemotherapy for metastatic disease.   "
252681|NCT01163435|"     Up to now, to our knowledge, there is few randomized, large scale study prospectively and     simultaneously comparing the efficacy, adverse effects and patient adherence of these current     recommended 1st-line or 2nd-line regimens for H. pylori eradication in and out of our     country.      The aims of this study are:        1. to compare the efficacy of high dose dual therapy, sequential therapy and          clarithromycin-based triple therapy as 1st-line regimen in H. pylori eradication;        2. to compare the efficacy of high dose dual therapy, sequential therapy and          levofloxacin-based triple therapy as rescue regimen in H. pylori eradication;        3. to compare the patient adherence and adverse effects of these treatment regimens;        4. to investigate factors that may influence H. pylori eradication by these treatment          regimens;        5. to investigate and analyze the prevalence and trend of antibiotic resistance.   "
252682|NCT01163448|"     This study is being done to test the safety of a single high-dose of radiation therapy before     radical prostatectomy (removal of the prostate). The investigators want to find out what     effects, good and/or bad, the radiation will have on men undergoing prostatectomy. The     investigators are especially interested in men who are at risk for having cancer cells that     have spread outside the prostate.   "
252684|NCT01163474|"     Telemedicine has been widely used in managing patients with neurologic disorders or mental     illness. Telemedicine is defined as the use of medical information exchanged from one site to     another via electronic communications for the health and education of the patient or     healthcare provider and for the purpose of improving patient care. According to our     knowledge, it has not been used to manage cardiac patients who need postoperative care after     discharge from hospitals.      The use of telemedicine has the potential to reduce the cost of unnecessary travel by     assessing the patient's postoperative status prior to making decisions as to whether or not a     face-to-face consultation is necessary.      In this pilot study we will compare the accuracy of surgeons' decisions during follow-up     visits via video-teleconference (V-Visit) to surgeons' decisions during traditional     face-to-face follow-up visits (FTF-Visits). Both the V-Visit and the FTF-Visit will take     place at the Houston Michael E DeBakey VA Medical Center on the same day. We will also ask     both patients and providers to complete short questionnaires after each V-Visit regarding     their acceptability of using telemedicine for these post-operative follow-up visits.      Information collected as part of this pilot study will be used to design a future full     randomized controlled trial (RCT) on the use of telemedicine in evaluating post-operative     cardiac surgical patients.   "
252685|NCT01163487|"     The purpose of this study is to study the effect of the drug DCA (dichloroacetate) on     recurrent head and neck cancers. Part of this study will also use EF5 PET scan to study tumor     hypoxia.   "
252698|NCT01163656|"     The investigators seek to prospectively compare intubation with the Glidescope Cobalt to     Direct Laryngoscopy (DL) in infants.   "
252713|NCT01157728|"     Cognitive impairment is one of the symptoms of Multiple Sclerosis (MS), and it may occur     during the first years of the disease. It usually affects attention, information processing     speed and short term memory. To date, the mechanisms of this specific symptom remain unclear     (local or global inflammation, neurodegenerative processes).      Magnetic Resonance Imaging (MRI) can be useful to understand the pathophysiology of cognitive     impairment in MS. The investigators will combine conventional and non conventional MRI     sequences to determine the respective role of white matter and grey matter injury and the     cortical reorganization of neuronal networks.   "
253971|NCT01179113|"     The purpose of this study is to evaluate the effects of esmolol, a drug which is commonly     administered during surgery to help control blood pressure and heart rate, on postoperative     pain levels and requirements for pain medication.   "
252686|NCT01163500|"     Coenzyme Q10 (Ubiquinone) is recognized as an endogenous fat-soluble antioxidant in the     mitochondrial membrane and considered as a preventive factor for coronary artery disease     (CAD). However, the relationships between coenzyme Q10 and the prevention of the risk of CAD     are still inconsistent. The purposes of this study are to investigate the relation of     coenzyme Q10 concentration with the blood lipid levels, plasma homocysteine, the markers of     lipid peroxidation (TBARS, ox-LDL),antioxidant enzymes activities (catalase, glutathione     peroxidase, superoxide dismutase)and to examine the association with the risk of CAD.The CAD     patients is identified by cardiac catheterization as having at least 50% stenosis of one     major coronary artery (n = 100). The second year is a double-blind, placebo-controlled     intervention study. CAD subjects (n = 60) are randomly assign to one of the three groups     (coenzyme Q10 supplements 60 mg/d, 150 mg/d, and placebo groups, n = 20/group). Intervention     is going to administration for three months. The third year is a case-control study. The     control group （n = 100） is comprised of healthy individuals with normal blood biochemical     values, and match by age and gender with the first year CAD subjects (case group). Fasting     blood samples will be obtain to determine the concentration of coenzyme Q10, homocysteine,     the markers of lipid peroxidation,antioxidant enzymes activities. The differences between     case and control groups will be compared by using Student's t-test. Conditional logistical     regression model will be performed to calculate the odds ratio for CAD based on coenzyme Q10     level. Hopefully, the results of this study could provide the information to what has been     know in CAD subjects. We expect coenzyme Q10 could be a preventive supplement to reduce the     risk of CAD.   "
252687|NCT01163513|"     The purpose of this study is to determine the extent to which South Asian ethnicity is both     an etiologic and prognostic factor for coronary disease, and investigate factors influencing     outcomes.   "
252688|NCT01163526|"     A research study of liver perfusion (how blood flows to the liver over time). We hope to     learn whether perfusion characteristics of liver masses may be predictive of response to     treatment and whether liver perfusion characteristics can be used to follow response to     treatment.   "
252689|NCT01163539|"     The purpose of this study is to look at pain control and QOL improvement after treatment with     CK Radiosurgery for spinal metastases.   "
252690|NCT01163552|"     Cancers that have spread to the inner lining of the chest are classified as Stage IV and bear     a poor prognosis. Surgery is rarely an option, with palliative chemotherapy and/or radiation     therapy the only treatment options. This study intends to evaluate whether surgical removal     of all visible tumor on the chest wall followed by bathing the chest cavity in heated     chemotherapy solution will improve outcomes for these advanced cancers.   "
252691|NCT01163565|"     This is a randomized, prospective equivalence trial on the safety of the Ligasure Vessel     Sealing System as used in thyroid surgery. The Ligasure system is a hand held surgical device     that uses heat to seal blood vessels during surgery. It has been a tested and accepted     technology in abdominal surgery and it is now being applied to surgery of the thyroid gland     because it is faster than the traditional method of tying blood vessels that a surgeon must     do manually. To remove the thyroid gland safely the surgeon must dissect the gland away from     the recurrent laryngeal nerve which controls the vocal cords and patient's voice. Protecting     this nerve is the key step in all thyroid surgery as its damage can permanently alter a     patient's voice and even obstruct the airway. At this time the worldwide accepted rate of     nerve injury is 2 in 100 patients. The hypothesis of this study is that the nerve injury     rates for surgery using the Ligasure device are similar to that seen when surgeons manually     tie blood vessels. The investigators protocol will evaluate the function of the recurrent     laryngeal nerve after removing the thyroid gland using the Ligasure device in comparison to     the traditional method where the surgeon manually ties blood vessels. In this study, for     patients undergoing total thyroidectomy for a benign condition, each patient will be     randomized to have one lobe of thyroid (left or right) removed using manual tying of blood     vessels and the other side will have the surgeon use the Ligasure device to seal blood     vessels. Every patient has a pre− and post−operative independent assessment of vocal cord     function using nasopharyngoscopy to ensure that the vocal cords are working normally prior to     surgery and also to document vocal cord dysfunction if there is an injury to the recurrent     laryngeal nerve. The investigators intent is to show that the Ligasure system is a safe     method to sealing vessels in thyroid surgery and that the thermal dispersion of this device     does not pose a significant increase in risk to the recurrent laryngeal nerve   "
252692|NCT01163578|"     The objective of this study is to evaluate whether certain proteins, expressed in biological     tissues can indict a better understanding of the effect of drugs that are used to treat     rejection, and of processes leading to rejection and rejection-free outcomes.   "
252693|NCT01163591|"     Diabetes mellitus (DM) is a metabolic disorder commonly encountered by the healthcare     professionals. Diabetic nephropathy is one of its complications, which is becoming the most     common cause of end-stage renal failure in Hong Kong. As of March 31, 2000, a total of 1026     patients with diabetes were on renal replacement therapy and the number is steadily     increasing. According to ADA guidelines, screening for diabetic nephropathy should be     performed on an annual basis to assess urine albumin excretion rate. Serum creatinine should     also be measured in all diabetic patients regardless of the degree of urine albumin excretion     rate. Timed urinary collection can be a cumbersome procedure for patients and a simpler and     fast test that maintains reasonable sensitivity is called for. A tool that is non-invasive     and able to identify patients with early nephropathy changes would be valuable.      The skin has been found to have the potential to provide an important non-invasive route for     diagnostic monitoring of human subjects for a wide range of applications. eZscan® technology     is a patented active electrophysiological technology which uses low level DC-inducing reverse     iontophoresis, together with chronoamperometry, to evaluate the behaviour of the tissues in     specific locations of the body. This non invasive test is a potential tool for the screening     for diabetic nephropathy.      The aim of this study is to compare eZscan with the standard methods of screening for     diabetic nephropathy in patients with type 2 diabetes mellitus.   "
252694|NCT01163604|"     Argatroban is a selective thrombin inhibitor, and previous study had suggested that     argatroban use post PCI could potentially prevent reocclusion. But there has no study on     large sample of argatroban treated restenosis post cranial stenting. This study will test the     safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with     intracranial and extracranial artery stenting.   "
252695|NCT01163617|"     This was an open-label, Phase 2 study designed to obtain user experience data (Phase A) and     injection time data (Phase B) in experienced adalimumab patients injected with the Physiolis     pre-filled syringe and autoinjector used to administer adalimumab.   "
252696|NCT01163630|"     The purpose of the study is to investigate the effects of food, in comparison to fasting     conditions, on the extent and rate of absorption of acetylsalicylic acid (ASA) and     esomeprazole.   "
252697|NCT01163643|"     The objective of this study is to identify the concentration and daily dosing frequency of     BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.   "
252699|NCT01163669|"     The purpose of this study is to see if Hyperparathyroidism (HPT) is common in people who     receive a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH)     levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone     disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor     formation of red blood cells. Other problems from HPT may include increases in blood levels     of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high     calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause     arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft     tissue), heart and lung problems, or kidney transplant dysfunction (worsening of kidney     transplant function). The purpose of this research study is to better understand the     evolution of Hpt in people during the first 12 months after receiving a kidney transplant.   "
252700|NCT01163682|"     This is a two arm randomized pilot study. This study seeks to determine if 12 weeks of weekly     electroacupuncture will prevent or decrease neuropathic pain in breast cancer patients     receiving 12 weekly treatments of taxane treatment.   "
252701|NCT01163695|"     This study examines an economic empowerment model of care and support for orphaned     adolescents in rural Uganda. The Suubi intervention focuses on economic empowerment of     families caring for orphaned youths. It attempts to address the health risks and poor     educational achievements resulting from poverty and limited options.   "
252702|NCT01157572|"     The primary objective of this study is to evaluate the effect of beta-blocker on left     ventricular (LV) remodeling in asymptomatic patients with moderate to severe aortic     regurgitation.   "
252703|NCT01157585|"     The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients     with first episode psychosis.   "
252704|NCT01157598|"     Background: Endoscopic submucosal dissection (ESD) usually requires adequate level of     sedation due to lengthy and uncomfortable procedure. Propofol induced sedation with     bispectral index (BIS) monitoring has been reported to lead to higher satisfaction of     patients and endoscopists during ESD. However, there is no data about efficacy of midazolam     and meperidine induced sedation with BIS monitoring during ESD. This study was to evaluate     whether midazolam and meperidine induced sedation with BIS monitoring could improve the     satisfaction and reduce the dose of midazolam and meperidine during ESD.   "
252744|NCT01164020|"     Resistance training as well as creatine supplementation may be beneficial for cognitive     function, such as memory and attention. Therefore, the investigators speculate that     resistance training combined with creatine supplementation would promote additive benefits on     cognitive function in elderly women.   "
252705|NCT01157611|"     Purpose:      To evaluate the effects of online based mentoring program on the blood glucose and     satisfaction score in type 1 diabetes patients. Peer group mentoring will be as effective as     guidance by the doctors.      Methods:      80 type 1 patients will be randomly divided into two groups (e.g. mentoring program group and     control group). All patients will receive routine check up and blood test for ordinary type 1     patients. In addition, program group patients should register their SMBG, exercise, food     intake and insulin dose on the website designed for this study and receive advices of mentors     from peer group. Every patient will submit questionnaire on the first day of the study and     the last day(after 12 weeks) of the study.   "
252706|NCT01157624|"     The investigators hypothesize that this new nasal cannula will prevent lack of oxygen as well     as reduce rebreathing of carbon dioxide under ophthalmic drapes during eye surgery.   "
252707|NCT01157650|"     Primary outcome measure:      Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells     implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse     events occurred during the study.      Secondary outcome measures:        1. Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular:             -  Fistulas healing efficiency             -  Changes in quality of life in patients treated             -  Changes of systemic Crohn's disease after implant             -  Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem               Cells treatment success.        2. Achieving the biological characterization of the cell product used and its correlation          with the therapeutic effect measured with:             -  Phenotype study             -  Suppressor capacity study.             -  Citoquines production analysis   "
252708|NCT01157663|"     Ankle sprain is the most occurring sport related injury. In addition, 40% of the people who     sustain such an injury display residual symptoms under the general denominator functional     ankle instability (FAI). In literature, there is already given a lot of attention to     extrinsic and intrinsic risk factors of FAI. Furthermore, there is a major focus on the     possible interventions which may be able to reduce the chance of developing chronic     instability. At this moment there is a lack of unequivocality.      In this study the investigators address the question of what is the effect of a balance     training programme on the movement strategy. Therefore kinematics, kinetics, plantar pressure     measurements and muscle activity are taken in consideration The purpose of this study is a     better insight in the effect of treatment on the residual symptoms related to FAI.   "
252709|NCT01157676|"     This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and     functional outcomes following two standard care procedures for radical cystectomy. The     participants will have one of the standard care procedures as part of their care. The two     procedures that will be followed are open radical cystectomy and robotic assisted radical     cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While     newer, RARC is considered to be equivalent to open surgery when it is performed by a trained     robotics surgeon. The reported complication rates of RARC appear comparable to open surgery.     This means there is no significant difference in the risk between the two standard     procedures. However, despite these potential advantages, true comparison between the open and     robotic technique with regards to long term cancer related and functional outcomes has not     been accomplished because previous studies did not compare patients of equal health status.     The researchers hope to learn whether or not patients undergoing RARC recover more quickly     than or at the same rate as patients undergoing an open radical cystectomy while having non     inferior cancer related outcomes. This study is funded by the National Institutes of Health     (NIH).   "
252710|NCT01157689|"     The routine treatment of children with antimalarials will be monitored. Children with a     positive malaria film and/or a positive rapid diagnostic test (RDT) will be included in a     follow-up study. The genetic basis of the parasites for developing resistance will be     examined. In case of reappearance of parasites the child will be re-treated following the     guidelines of the national malaria programme.   "
252714|NCT01157741|"     Improved methods of community/home management and follow-up of severely undernourished     children need to be developed in low-income countries like Bangladesh. The proposed study     will be conducted at ICDDR,B Hospital and in different urban primary health care centres     within Dhaka city. The efficacy of four different interventions will be evaluated/compared     with control with respect to the rate of completion of clinical follow-up and growth,     morbidity, and changes in psychomotor development in 500 children aged 6-24 months presenting     to ICDDR,B with initial weight-for-age (WA) <-3 Z score. The interventions are:        1. Usual follow-up (fortnightly for 1st 3 months) service at the hospital nutrition          follow-up unit (HNFU) including growth monitoring and promotion + health education +          micronutrient supplementation and treatment of intercurrent illness (current standard          practice; control group).        2. All management like control group, but follow up at community-based nutrition follow-up          unit (CNFU) (fortnightly for 1st 3 months) (intervention A).        3. All management like intervention A at CNFU + supplementary food (SF) for the first 3          months (intervention B).        4. All management like intervention A at CNFU + psychosocial stimulation (PS) for the first          3 months (intervention C).        5. All management like intervention A at CNFU + SF + PS for the first 3 months          (intervention D).      After the initial three months intervention period, children in all groups will be followed     on fortnightly basis for next three months in their respective follow up unit.      Follow-up rate, nutritional status, mental and psychomotor development, behavior, morbidities     (including intestinal permeability in a sub-sample) of the children, and child rearing     practices, depression and self esteem of mothers will be assessed in different groups.      By ascertaining the most cost-effective/best management package, and by extending the package     to other systems in the country, it will be possible to rehabilitate a greater number of     severely malnourished children in their communities.   "
252715|NCT01157754|"     Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH     antagonist IVF cycles. The investigators performed this study to compare such a protocol with     the gold-standard still today, which is the long-agonist protocol with no previous use of the     pill.   "
252716|NCT01157767|"     The purpose of this study is to study if a patients follows an exercise program specifically     designed for them during the time of their treatment after surgery. Their ability to follow     the program and its influence on their weight maintenance and early post-operative lymphedema     rates will also be studied. Lymphedema is a condition in which excess fluid collects in     tissue and causes swelling of the arm(s).   "
252745|NCT01164033|"     This open-label, randomized, cross-over study will evaluate the effect of food on the     pharmacokinetics of single oral doses of RO5045337 in patients with solid tumors. The     anticipated time on study treatment is 3 weeks.   "
252746|NCT01164605|"     The substitution of raltegravir for the NRTIs will result in some reversal of the long term     adverse effect of lipodystrophy (specifically peripheral lipoatrophy) that is associated with     the chronic use of NRTIs. Changing the HAART regimen in patients with a sustained virological     response from a PI plus NRTI to a regimen of the PI plus raltegravir will likely result in     continued virologic efficacy.   "
252717|NCT01157780|"     Cholestatic liver disease is a common complication associated with long term parenteral     nutrition (PN). PN associated liver disease (PNALD) is much more common in premature infants     and the incidence increases with duration of PN. The use of intravenous omega-3 long chain     polyunsaturated fatty acids (ω3PUFA) or fish oil has recently shown promise in the treatment     of PNALD. We hypothesize that there are early markers for PNALD that precede the increase in     total and direct bilirubin. We further hypothesize that patients with PNALD who receive     enteral ω3PUFA supplementation will have an improvement in PNALD or reversal of PNALD. These     hypotheses will be tested by a two part study that includes an initial observation period     when markers for PNALD are evaluated, followed by a randomized, controlled trial of enteral     ω3PUFA supplementation for treatment of PNALD. Infants expected to be on PN for 4 weeks or     longer will be eligible for enrollment in this study. The observational part of the study     will entail periodic assessment of potential markers for PNALD. Markers will be evaluated for     inflammatory cytokines (IL-1, IL-6, TNF-alpha), oxidative stress (8-isoprostane,     8-hydroxydeoxyguanosine, glutathione peroxidase), liver fibrosis (TIMP-1), endogenous steroid     production (glucagon and ACTH), total serum bile acids, essential fatty acid profiles, and     calprotectin, a novel marker of gut inflammation. Patients will be observed for 6 months     duration. Patients enrolled in the study who develop PNALD will be randomized to either the     current standard of care (control group) or enteral ω3PUFA supplementation (treatment group).     Once able to take oral medications, treatment group patients will receive enteral ω3PUFA 1     g/kg/day for 12 weeks. At the end of the 12 weeks, the protocol will be open label in which     any patients who continue to have PNALD in either group will receive enteral ω3PUFA. All     patients enrolled in the study (whether or not they develop PNALD or receive ω3PUFA     supplementation) will be followed for a total of 6 months. The results of this study will     increase our knowledge of the pathogenesis of PNALD, as well as potentially confirm the     effectiveness of a novel therapy for this costly and debilitating disease.   "
252718|NCT01157793|"     This was a 48-week, open-label, prospective, multicentric, randomised, comparative with     parallel control, Phase 4 study to evaluate the effects of Saizen on cardiac function in GHD     subjects during the transition phase from childhood to adulthood.      The study was designed to evaluate whether recombinant-human growth hormone (r-hGH) treatment     also benefits young subjects with GHD. Some trials have already been published on this     subject, but they were mainly focused on the bone density.   "
252719|NCT01157806|"     Short course palliative radiotherapy (5x5Gy)to the pelvis in patients with symptomatic rectal     tumours and with unresectable metastases may prevent palliative surgery with a good     palliative outcome.The consolidating chemotherapy of XELOX may increase the efficacy of     irradiation.   "
252720|NCT01163708|"     This project aims to assess two different techniques used to position the knee replacement     implant during surgery. The patients will be randomised to receive either the following:        1. The established Navigation System (gold standard)        2. The new Prophecy Technique (validated by the Navigation System)      The study hypothesis is there will be no difference between the gold standard Navigation     system and the Prophecy technique in relation to the placement of the knee implant.   "
252721|NCT01163721|"     This study enrolled participants with inadequately controlled type 2 diabetes mellitus (T2DM)     despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have     benefited from additional control of blood glucose levels. The study assessed the metabolic     effects of ranolazine, including its effect in lowering glycosylated hemoglobin A1c (HbA1c),     and lowering glucose while fasting, and following a meal (postprandial).      Participants were randomized in a 1:1 ratio to receive ranolazine or placebo, and were     stratified by HbA1c ≤ 7.5% or > 7.5%. Enrollment was to include no more than two-thirds of     participants with baseline HbA1c ≤ 7.5%. Other than glucose values, efficacy endpoint results     remained blinded during the study; for safety purposes, the investigator was to be alerted of     severe hyperglycemia or hypoglycemia.      Participants were instructed to maintain logs of their physical activity/exercise (Subject     Activity Assessment) and study drug dosing (Dosing Log).   "
252722|NCT01163734|"     Patients with CAD and clinical symptoms of heart failure or patients with suspected heart     failure with preserved ejection fraction (HFpEF) will be enrolled. Study drug will be given     as continuous IV infusion followed by oral treatment for 13 days. LV pressures and     hemodynamic data will be measured prior to and after administration of study drug. In     addition, Doppler ECHO, cardiopulmonary exercise testing (CPET), and NT-pro-BNP determination     will be performed. Adverse events and safety labs will be collected and monitored.   "
252723|NCT01163747|"     This randomized, parallel-group, open-label study will evaluate the effect of Actemra     (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an     inadequate response to methotrexate and who have had an inadequate clinical response or were     intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.   "
252724|NCT01163760|"     This study seeks to evaluate the clinical performance of two daily disposable contact lenses.   "
252734|NCT01163890|"     The Work and Health Initiative (WHI) trial is testing an innovative, community-based program     that provides mental health and vocational services to workers 50 years or older to improve     functioning and reduce productivity loss. The purpose of this study is to test the hypothesis     that relative to usual care, the WHI improves the work outcomes of depression and reduces     depression-related productivity loss.   "
252725|NCT01163773|"     Cardiovascular disease (CVD) represents the first cause of mortality in industrialized     countries such as Canada and the United States. In that regard, it is being increasingly     recognized that a significant proportion of CVD events may be attributable to the presence of     a cluster of metabolic and physiological perturbations defined as the metabolic syndrome     (MetS). The National Cholesterol Education Program- Adult Treatment Panel III (NCEP-ATP III)     has recently proposed a clinical definition to identify individuals with the MetS. This     definition is based on the presence of at least three of the following five characteristics:     1- abdominal obesity, 2- hypertriglyceridemia, 3- reduced plasma HDL-C levels, 4- high blood     pressure, 5- high fasting blood glucose levels. Recent data have suggested that the MetS     based on this definition was associated with a 2 to 5 fold increase in the risk of CVD in men     as well as in women. These are alarming figures since it has been suggested that as much as     35 to 45% of female aged > 65 years in the US may have the MetS. It is therefore imperative     to develop new preventive strategies that will be efficacious in attenuating the impact of     the MetS on the progressing rates of CVD in women. In that context, there is accumulating     evidence to suggest that milk and dairy products may beneficially modify several components     of the MetS. However, most of the available data to date are based on observational studies     or interventional studies with minimal nutritional control. Thus, metabolically controlled     studies that document the impact of milk consumption on cardiovascular risk factors     associated with the MetS in women defined a priori as having the MetS are utterly lacking.      The purpose of this study was to investigate the impact of milk consumption on features of     the MetS in menopausal women presenting one or more features of the MetS.   "
252747|NCT01164618|"     The purpose of this study is to assess the effects of repeated RIPC and exercise, on exercise     performance, skeletal muscle responses and circulating cellular and humoral biology in humans   "
252888|NCT01166451|"     The purpose of this clinical trial was to determine if high-iron or low-iron formula,     containing an average of 12.7 mg/L or 2.3 mg/L respectively, had differing effects on iron     status in infancy and on development longitudinally.   "
252726|NCT01163786|"     Approximately 10,000 allogeneic hematopoietic stem cell transplants (HSCT) are performed     annually in the US for various indications. Bronchiolitis obliterans (BO) is the most common     late noninfectious complication following allogeneic hematopoietic stem cell transplant.     Prognosis of BO in the allogeneic HSCT setting is dismal and there are no therapies proven to     be consistently effective. The exact incidence is not clear but may be as high as 30%2 . Risk     factors include new or ongoing chronic graft versus host disease (cGVHD), age, antecedent     obstructive airways disease and viral infections1. BO is characterized physiologically by     progressive irreversible airflow obstruction and pathologically by luminal occlusion of the     distal airways due to progressive scarring3. The pathogenesis is not completely understood     but the cytokine transforming growth factor-beta 1 (TGF-b1), important for both tissue repair     and fibrosis, is thought to play a pivotal role. Bortezomib, an FDA approved proteasomal     inhibitor inhibits TGF-b1 signaling in vitro and protects against lung injury/fibrosis in     bleomycin mouse model as well as in a mouse model for skin fibrosis. This is consistent with     other data in the literature that proteasomal inhibition can prevent the development of     fibrosis. Thus the investigators propose to test the safety, tolerability and efficacy of     bortezomib in chronic pulmonary GVHD (BO).   "
252727|NCT01163799|"     The purpose of this study is to assess Alefacept in combination with alemtuzumab induction     and calcineurin inhibitor and corticosteroid withdrawal.   "
252728|NCT01163812|"     Objectives of this study was to determine whether laparoscopy-assisted distal gastrectomy     (LADG) with complete D2 lymph node dissection for gastric cancer is a safe and effective     surgical option.      Methods: total 64 patients, who are diagnosed preoperatively as having T1-2, N0-1 or M0     gastric cancer, will be prospectively enrolled to undergo LADG with D2 lymph node dissection;     two surgeons with experience of over 50 cases of laparoscopic gastrectomy performed the     procedures. The compliance rate, defined as cases with no more than one missing lymph node     station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node     grouping, for the open gastrectomy with D2 lymph node dissection was 66.0% in a pilot study     and was used for calculations of sample size. Compliance rate and other surgical outcomes,     including the number of retrieved lymph nodes from each lymph node station, morbidities,     mortalities and conversion rate will be analyzed.   "
252729|NCT01163825|"     Cholinergic neurons in the basal forebrain project widely to the cerebral cortex and     hippocampus. These neurons depend on nerve growth factor (NGF) from their target areas for     survival. Impaired NGF supply is part of the Alzheimer's disease (AD) pathology, and the     degeneration of these neurons correlates with the cognitive decline in these patients. The     objective of encapsulated cell biodelivery (ECB) is to maintain normal levels of NGF to     support cholinergic function. NsGene's NGF secreting ECB device (NsG0202) combines the     potential benefits of targeted gene therapy with the safety of a retrievable implantable     device.      The study is an open label, single centre, 12-month, dose-escalation phase Ib study in     patients with mild to moderate AD. The primary objective is safety and tolerability, while     secondary outcomes measure include cognition, behaviour, neuropsychology, activities of daily     living (ADL), positron emission tomography (PET) imaging and electroencephalography (EEG).   "
252730|NCT01163838|"     The primary objective of this study is to evaluate the safety and tolerability of repeated     doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is     currently being studied as a cholesterol lowering therapy.   "
252731|NCT01163851|"     The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics     of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin.     PF-04950615 (RN316) is an investigational drug that is currently being studies as a     cholesterol lowering therapy.   "
252732|NCT01163864|"     Recent data indicate that approximately one-third of women of childbearing age smoke     cigarettes, and 25-50% of women smoke during pregnancy. Cigarette smoking during pregnancy is     a significant public health issue that can have profound effects on women's health and the     health of their developing fetus. Smoking among pregnant women is associated with high levels     of negative affect, which play a key role in the maintenance of smoking behavior and in     difficulty quitting smoking during pregnancy. Despite the clear role of negative affect in     the maintenance of smoking among pregnant women, and while this issue has received increased     attention by clinicians and researchers, the investigators know of no smoking cessation     intervention that combines coping skills and emotion regulation approaches to address the     role of negative affect in smoking cessation. Smoking cessation treatment strategies that     have demonstrated effectiveness in regular smokers have not translated into effective     treatment strategies for pregnant women, particularly low-income pregnant women. The goal of     this project is to develop and test an affect regulation smoking cessation intervention for     low-income pregnant smokers.      The major aims of this project will be addressed in two sequential phases. In Phase 1, the     investigators will develop two 8-session smoking cessation treatment manuals including: (a)     Affect Regulation Training plus Cognitive-Behavioral Treatment (ART+CBT) and (b) a Health and     Lifestyle plus Cognitive-Behavioral Treatment (HLS+CBT) control intervention. In Phase 2, the     investigators will conduct a randomized clinical trial pilot study (Total N = 60) to compare     the ART+CBT and HLS+CBT conditions on: a) the feasibility and acceptability of the     interventions, (b) the impact of these interventions (ART+CBT and HLS+CBT) on smoking     cessation rates at the end of the 8 treatment sessions (these occur approximately 2 months     after treatment initiation) and at the 6-month post-quit date assessment (Session 2 is the     quit date), (c) affect regulation skills, and (d) negative affect among pregnant smokers. The     long-term goal of this proposed research is to increase smoking cessation rates among     pregnant smokers, which would provide significant long-term health benefits for both mothers     and their infants. This Stage 1 application will be used to generate feasibility and     preliminary efficacy data, setting the stage for a Stage II efficacy trial.   "
252733|NCT01163877|"     The aim of this study is to investigate the change in iron metabolism in relation to malaria     and helminth infections using a stable isotope technique.   "
252778|NCT01165021|"     The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin     can reduce tumor size.   "
252735|NCT01163903|"     This is a single-centre, open label, dose finding, phase I study to determine the recommended     phase II dose (RP2D) for the combination of doxorubicin and pantoprazole in patients with     advanced tumours and no standard treatment options. A minimum of 3 patients will be enrolled     per dose level and intra-patient dose escalation is not permitted. Once the RP2D has been     identified, six additional patients with metastatic solid tumours will be treated at the RP2D     to confirm its tolerability.   "
252736|NCT01163916|"     The primary objective of this post-marketing observational study was to obtain data on the     characteristics (patient age/gender; disease type, severity and duration; disease specific     treatment history; current concomitant medications; other relevant medical history) of     patients prescribed adalimumab (Humira®) for rheumatoid arthritis (RA), ankylosing     spondylitis (AS) and psoriatic arthritis (PsA) as part of routine clinical care in Russia.   "
252737|NCT01163929|"     The primary objective of this study is to assess whether a combination of chemotherapy,     Trastuzumab and RAD001 will result in no evidence of microscopic disease at the time of     surgery in 50% of enrolled patients.   "
252748|NCT01164631|"     Enlarged tonsils and malocclusion have relationship with sleep disturbance in children. The     consequences of these features can include deviation of normal craniofacial growth such that     this may result in a facial morphology more suitable to the development of sleep apnea later     in life. The aim of this study was to compare the growth redirection, the evolution of     respiratory symptoms and the pharyngeal size of snoring children with obstructive tonsils     from the waiting list for surgery treated with the Bioajusta X orthodontic appliance.This new     protocol of orthodontic treatment promotes maxillary expansion, mandibular advancement and     proper tongue positioning on swallowing , that together may be helpful on remodeling the     upper airways.   "
252749|NCT01164644|"     Arnica montana is a homeopathic drug that is made in accordance with the official methods of     the Homeopathic Pharmacopoeia of the United States (HPUS) and is commonly used by cosmetic     surgeons throughout the world, although there is no study proving its benefit after     rhinoplasty surgery. The purpose of the research is to see if Arnica montana will reduce the     amount of bruising and the intensity of the bruising after surgery. Photographs of the     subject's face will be taken and used to analyze bruising after rhinoplasty surgery in     subjects who receive Arnica montana and compare them to photographs of subjects who take a     placebo (sugar pill).   "
252750|NCT01164657|"     Background:      The World Health Organization (WHO) advises against recumbent or supine position for longer     periods during labour and birth and states that caregivers should encourage and support the     woman to take the position she finds most comfortable. It has been suggested that upright     positions may improve childbirth outcomes and reduce the risk for instrumental delivery.      Objective:      The primary objective was to test the hypothesis that birthing on the BirthRite ® seat will     result in a reduction in the number of primiparous women delivered instrumentally.      Method:      A power calculation showed (α = 0.05 β = 0.2) a requirement of 460 participants in each of     the two arms of the trial in order to test for a 40% reduction (from 15% to 9%) of     instrumental deliveries in primiparous women at a maternity unit in southern Sweden. It was     decided to subject the study to a feasibility test by conducting a pilot-study in which 68     women were randomised to give birth on the birthing seat or to give birth in any other     position but on the BirthRite ® seat. Randomization to birth on the birthing seat or in any     other position took place when the participant's cervix was fully dilated. The primary     outcome measurement was the number of instrumental deliveries. Secondary outcome measurements     included oxytocin augmentation, perineal trauma, and blood loss administration of oxytocin     for augmentation of labour, length of the second stage of labour, perineal trauma, perineal     oedema, maternal blood loss and haemoglobin, apgar scores, cord pH and transfers to the     Neonatal Intensive Care Unit(NICU).   "
252841|NCT01165840|"     This study will find how weight affects the dosing of a drug called dapsone. Currently, the     amount of dapsone a patient receives is the same regardless of the patient's weight.   "
252751|NCT01164670|"     Sarcopenia, the age-related decline in muscle mass and function (widely recognized as     frailty), is increasingly being appreciated, primarily in the research environment.     Interventions to prevent or treat sarcopenia can be anticipated to reduce falls, fractures     and thereby to facilitate independence and improve quality of life for older adults.     Unfortunately, there is no current consensus definition of sarcopenia, thereby impeding     clinical recognition and treatment. It has been advocated that low appendicular (arm and leg)     lean mass, as measured by DXA, be utilized as a clinical diagnostic tool to define     sarcopenia. While such an approach is possible, however, muscle strength loss is more rapid     than mass loss, indicating deterioration of muscle quality. Muscle quality may be affected     by changes at the neuromuscular, cellular or subcellular levels; parameters not detected by     measuring mass alone. Clearly, tools evaluating muscle performance, not simply mass, are     needed to optimally identify, and subsequently monitor, treatment of older adults with     sarcopenia. While current tests of muscle power/function (e.g., chair-rising, self-selected     gait velocity, etc.) do correlate with functional limitation in older adults, these existing     tests have limitations in that they cannot be performed in all people, may have yes/no     results rather than a continuous scale and may not be highly precise. Thus, improved muscle     function assessment tools are needed, both clinically and in research venues. Jumping     mechanography is very likely one such methodology.   "
252752|NCT01164683|"     Obstructive sleep apnea (OSA) is a highly prevalent condition in veterans with some estimates     as high as 47%. Poor adherence to the primary treatment of OSA -- continuous positive airway     pressure (CPAP) therapy - is associated with increased risk for heart attacks, strokes and     even death. The investigators plan to improve CPAP adherence in veterans through their     interactions with peers who have successfully adopted CPAP therapy.      Such peer-buddies may promote the well-being of veterans while remaining highly     cost-effective when compared to healthcare providers. Our strategy is grounded on the     rationale that veterans as a group are ecoculturally more homogenous than expected for the     given level of differences in age, gender, ethnicity, or socioeconomic strata. Our long-term     objectives are to initiate a larger, multi-site, research study for enhancing CPAP adherence     in veterans with OSA. The ultimate goal of this research is to develop a cheap, effective and     exportable system of care to promote CPAP adherence in patients with OSA.   "
252753|NCT01164696|"     The objective of this study is to compare hematological toxicity, costs, health-related     quality of Life (HR-QOL) and outcomes observed in real life in the Belgian Non-Hodgkin     Lymphoma (NHL) population receiving 90Y-Zevalin, with model-predicted data at reimbursement     on the basis of a clinical trial in heavily pre-treated NHL.   "
252754|NCT01164709|"     RATIONALE: Nelfinavir mesylate and bortezomib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Bortezomib may also stop the growth of     hematologic cancer by blocking blood flow to the cancer. Giving nelfinavir mesylate together     with bortezomib may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate     when given together with bortezomib in treating patients with relapsed or progressive     advanced hematologic cancer.   "
252755|NCT01164722|"     RATIONALE: Infrared coagulator ablation may be effective in preventing the development of     anal cancer in patients with anal neoplasia      PURPOSE: This randomized phase III trial is studying infrared coagulator ablation to see how     well it works compared to observation in preventing anal cancer in HIV-positive patients with     anal neoplasia.   "
252757|NCT01164748|"     Rationale: Like in primary breast cancer, prognosis in recurrent breast cancer is correlated     with regional lymph node status. Therefore, axillary staging may be warranted in patients     with recurrent disease and intact axillary nodes, although this has not been described in     guidelines yet. The lymphatic drainage pathways in the breast and/or axilla could have been     changed due to prior surgery and/or radiotherapy. These aberrant drainage pathways could be     detected with lymphatic mapping and sentinel node biopsy (SNB), leading to a more accurate     staging.      Objective: To assess the technical feasibility of lymphoscintigraphy after prior breast     surgery. A second goal is to investigate whether or not previous breast surgery (with or     without radiotherapy) significantly changes the lymphatic drainage pathways of the breast.   "
252758|NCT01164761|"     The purpose of this study is        -  To characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to          that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under fasting          conditions and to assess the bioequivalence.        -  To monitor the safety of the subjects.   "
252759|NCT01164774|"     The purpose of this study is        -  To characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to          that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under non-fasting          conditions and to assess the bioequivalence.        -  To monitor the safety of the subjects.   "
252760|NCT01164787|"     The purpose of this study is        -  To compare the single oral dose bioavailability of test product, Trandolapril 4 mg          Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult,          human subjects, under fed conditions to assess bioequivalence.        -  To monitor adverse events and ensure safety of subjects.   "
252761|NCT01164800|"     The purpose of this study is        -  To compare the single oral dose bioavailability of test product, Trandolapril 4 mg          Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult,          human subjects, under fed conditions to assess bioequivalence.        -  To monitor adverse events and ensure safety of subjects.   "
252762|NCT01164813|"     The purpose of this study is:        -  To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg          tablets in healthy, adult, human subjects under fasting conditions with a washout period          of 14 days.        -  To monitor adverse events and ensure the safety of subjects.   "
252763|NCT01164826|"     The purpose of this study is:        -  To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg          tablets in healthy, adult, human subjects under fed conditions with a washout period of          16 days.        -  To monitor adverse events and ensure the safety of subjects.   "
252764|NCT01164839|"     The multicenter study evaluates the diagnostic performance of coronary Computed Tomography     Angiogram (CTA) with multi-slice computed tomography (MSCT) in comparison with X-ray coronary     angiography and the factors affecting the accuracy of coronary CTA in diagnosing stenosis of     coronary arteries. Furthermore, the study tends to establish the standard of image quality     and associated factors that may ensure accurate diagnosis of coronary stenosis with coronary     CTA.   "
252765|NCT01164852|"     How best to manage preeclampsia remote from term is controversial because of conflicting     maternal and neonatal risks. Gestational age is the most important determinant of neonatal     outcome. There are two basic approaches when delivery is not clear indicated by assessment of     maternal and fetal well-being. The interventionist care when the delivery is planned within     48 hours and the expectant care which refers to pregnancy prolongation during which time     women and fetuses are carefully monitored for indications for delivery.      The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs     interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of     gestation.   "
252766|NCT01164865|"     The purpose of this study was to assess comfort in soft contact lens wearers.   "
252767|NCT01164878|"     Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by     early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis     (PNAC).      Extreme low birth weight infants (ELBW, birth weight < 1000 g) are at increased risk for     development of PNAC.      Important factors implicated in the aetiology of PNAC are high caloric parenteral nutrition     using amino acids or dextrose, but also intravenous lipids and infections in particular     necrotizing enterocolitis (NEC).      Due to a change of paradigm a more aggressive nutrition with early use of parenteral amino     acids/lipids and early fortification of mothers milk or alternatively high caloric preterm     formula is warranted. Accordingly - in line with the existing expert opinion and evidence -     the feeding policy at the neonatal care units of our hospital was adapted.      Evidence exists that PNAC might be caused by the use of high concentrations of amino acids     and lipids in parenteral nutrition. Furthermore NEC is associated with high osmotic feeds.     Therefore the incidence of PNAC might be increased directly and indirectly after introducing     the new feeding policy.      The investigators therefore aim at retrospectively investigating the incidence of PNAC before     and after introduction of a feeding policy of aggressive nutrition for ELBW infants.   "
252768|NCT01164891|"     This open-label, non-randomized study will assess the mass balance, metabolism, routes and     rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032)     in previously treated or untreated patients with metastatic melanoma. Patients will receive     continuous twice daily oral treatment with RO5185426. On Day 15, a 14C-labeled dose will be     administered. Anticipated time on study treatment is until disease progression occurs.   "
252769|NCT01164904|"     To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses     of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate     ulcerative colitis (UC)   "
252770|NCT01164917|"     This is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover     study in which approximately 20 subjects with Discoid Lupus Erythematosus will be enrolled to     receive AMG 811 and placebo in one of two sequences (ie, AMG 811 followed by placebo or     placebo followed by AMG 811).   "
252771|NCT01164930|"     The purpose of this randomized controlled trial is to evaluate the effectiveness of an     empirically supported psychosocial treatment, Acceptance and Commitment Therapy, in     facilitating improved quality of life, benefit-finding, and cortisol rhythm in breast cancer     patients in an outpatient clinical oncology setting.   "
252772|NCT01164943|"     Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of     egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone     on aneuploidy rate it is unknown. If there was an increase on aneuploidy rate of one of these     stimulation protocols, there will be a negative effect on the successful rates in the egg     donation cycles. The aim of this study is to observe if there is a different in aneuploidy     rate and morphological oocyte parameters between different stimulation protocols.   "
252773|NCT01164956|"     The overall aim of this pilot study is to conduct a combined N-of-1 trial (N-1-T) of MPH     (methylphenidate) for amelioration of fatigue in children with cancer, and to evaluate the     N-1-T design both for individual clinical decision making and for clinical trials in symptom     management in pediatric oncology patients.   "
252774|NCT01164969|"     The purpose of this study is to determine whether mixed H. pylori strain infection is the     reason for eradication failure during treatment of H. pylori infection. The investigators     present the results got from extensive sampling of biopsy samples taken from individuals     diagnosed with H. pylori connected disease. The investigators were looking for individuals     that were not able to eradicate H. pylori although they had susceptibility testing tailored     antibiotic therapy. On their control visit after 2 months they presented again with H. pylori     although at their first visit they had H. pylori isolated from biopsy sample sensitive to all     antibiotics prescribed. Multi Locus Sequence Typing (MLST) was used to prove the sequence     type of H. pylori and E test was used to determine susceptibility of H. pylori to     antibiotics.   "
252775|NCT01164982|"     The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds     in home care.      Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at     removal, transparency of dressing and adverse events.   "
252776|NCT01164995|"     The purpose of this study is to determine if patients with p53 mutated epithelial ovarian     cancer that have been treated with first line treatment (paclitaxel - carboplatin combination     therapy) and that have shown early relapse (within 3 months) or progression during treatment     will benefit from treatment with Wee-1 inhibitor MK-1775 and carboplatin.   "
252777|NCT01165008|"     To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients     with treatment-resistant inflammatory myopathies.      Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis     (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per     day during 12 months. Outcome measures included myositis disease activity score with     improvement defined according to The International Myositis Assessment and Clinical Studies     Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition     repeat muscle biopsies were performed   "
252779|NCT01165034|"     Breathlessness is a common, distressing symptom in advanced malignant and non malignant     disease, and impacts significantly on quality of life. Breathlessness in end stage disease is     also responsible for significant healthcare resource usage. Escalante [1] reported hospital     admission rates of 60% in patients presenting to a cancer treatment centre with     breathlessness. Preliminary trials of breathlessness clinics with selected groups of patients     have been promising, but lack data on their cost effectiveness.      The principal aim of the research is to develop and evaluate the effectiveness and cost     effectiveness of a multidisciplinary outpatient breathlessness support service (BSS) for the     palliation of breathlessness, in advanced malignant and non malignant disease. This is a     phase II study that aims to test the hypothesis that a BSS will improve patient mastery over     breathlessness and reduce the use of healthcare resources (including GP     consultations,accident and emergency attendances, and length of hospital stay) compared with     usual best medical care alone (UC),at an acceptable level of cost effectiveness.The outcomes     of this study will also help to determine sample size,develop and test methods for a phase     III trial that will follow on from this project.      This study will run over 2 years. Breathless patients with advanced malignant and non     malignant disease who have already been optimally medically managed will be eligible.      The service will be run in the outpatient department of King's College Hospital, and patients     will also be assessed in their own home and by telephone interviews. At baseline we will     assess respiratory function and breathlessness mastery and severity using validated scales,     and health service usage. Individuals will be randomised to the intervention group [IG]     (n=55) or UC (n=55). The IG will attend the new outpatient clinical service with     multiprofessional input. Assessments will be repeated at 4, 10 & 24 weeks.      1.Escalante, C.P., Martin, C.G., Elting, L.S. et al., Dyspnea in cancer patients. Etiology,     resource utilization, and survival implications in a managed care world. Cancer, 1996. 78(6):     p. 13149.   "
252780|NCT01165047|"     The primary aim of the study is to evaluate the safety, tolerability and device performance     of the GeNO nitrosyl delivery system during RHC. Secondary considerations are to confirm that     inhaled NO generated by the GeNO nitrosyl delivery system, reduces PVR in patients with     reversible PH, contains levels of NO2 well below the upper level of acceptable exposure.     Further, the study aims to demonstrate that patient response to inhaled NO can be used as a     diagnostic tool with which to determine the proper course of medical action in patients with     chronic heart failure.      Patients with chronic heart failure accompanied by pulmonary hypertension and increased     pulmonary vascular resistance have a number of possible medical therapies available to them.     The least invasive, and therefore most appealing, option is standard management with     medication and observation. Alternatively, implantation of a left ventricular assist device     (LVAD) may be considered, either as a permanent solution or as a bridging strategy to the     final option, orthotopic heart transplantation (OHT). It is often unclear which route is the     best medical choice, and a tool to help physicians and patients choose between these     alternatives would be greatly beneficial.      It has been shown that chronic heart failure patients that demonstrate irreversible pulmonary     hypertension, even in the presence of vasodilators, exhibit adverse outcomes after OHT (Tsai     et al., 2002; Ericson et al., 1990; Murali et al., 1996). It follows that patient response to     pulmonary vasodilators can, and should be used to classify patients as potential candidates     for OHT. In particular, patient response to inhaled NO, a known pulmonary vasodilator, can be     used as a diagnostic tool to assist in deciding which medical route to take.      With this in mind, the current study aims to demonstrate whether or not NO generated by the     GeNO nitrosyl delivery system effects a reduction in pulmonary hypertension due to increased     pulmonary vascular resistance in patients with chronic heart failure. Any demonstrated     ability of inhaled NO to decrease PVR in patients with reversible PH will support the use of     patient response to inhaled NO as a diagnostic tool to assist in choosing the most     appropriate medical therapy for patients with chronic heart failure.   "
252792|NCT01165203|"     This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline     (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human     Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with     antiretroviral therapy (ART) and with high CD4 T cell counts, and subsequently ART-treated     subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts.      This Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010.     The impacted sections is exclusion criteria.   "
252793|NCT01165216|"     The primary purpose of this study was to establish the recommended dose of ipilimumab     administered in combination with paclitaxel and carboplatin in Japanese patients with     nonsmall-cell lung cancer.   "
252794|NCT01165229|"     The purpose of this observer-blind study is to evaluate the efficacy, safety and     immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70     years.      Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be conducted     concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both     studies combined will be conducted contingent on each study achieving its objectives. This     protocol posting also deals with the outcome measures related to the pooled analysis.   "
252781|NCT01165060|"     X-linked adrenoleukodystrophy (X-ALD) is an inherited metabolic disorder characterised by     accumulation of very long chain fatty acids (VLCFA) in plasma and tissue. Presumably this     accumulation is responsible for tissue damage. The disease can cause severe demyelinisation     of the central nervous system usually causing death in childhood or progressive ambulatory     problems in adults caused by a progressive myelopathy. For the latter category of patients no     curative treatment is currently available. Recent investigations in human fibroblasts and     mice identified bezafibrate as an agent that might reduce VLCFA in patients with X-ALD.      Objective of the study:      The trial is designed as an open-label pilot study. The main goal is to investigate if     bezafibrate can reduce VLCFA in vivo in patient with X-ALD. If there is indeed a biochemical     effect, a large follow-up study will be initiated with clinical outcome parameters.      Study design:      10 men with X-ALD will use bezafibrate during a period of 6 months (in combination with a low     fat diet). On 6 different time points the participants will undergo a venipuncture for     detecting possible side effects and to determine the biochemical outcome parameters.      Study population:      Adult men with X-linked adrenoleukodystrophy.      Intervention (if applicable):      Bezafibrate.      Primary study parameters/outcome of the study:      The primary outcome parameters are cholesterol levels (total-, LDL, and HDL) and levels of     triglycerides in plasma, VLCFA levels in plasma, leukocytes and erythrocytes and also     C26:0-lyso-PC in bloodspots.      Secondary study parameters/outcome of the study (if applicable):      Secondary outcome parameters are side-effects (subjective and abnormalities in the safety     lab).   "
252782|NCT01165073|"     The benefits of short-term naso-gastric feeding in patients with advanced cirrhosis remain     uncertain. This was a randomised study comparing naso-gastric feeding and oral feeding in     Asian patients with cirrhosis who were admitted to hospital for decompensation.   "
252783|NCT01165086|"     This study will test the hypothesis that incorporating vegetables into meals as a method of     reducing the energy density will result in increased vegetable intake and decreased energy     intake.   "
252784|NCT01165099|"     The study was primarily designed to assess the role of acupuncture in reducing the need for     epidural analgesia for pain relief during induced labour. The other outcomes of labour were     to be observed in addition.   "
252785|NCT01165112|"     This phase I/II trial is studying the side effects and best dose of bendamustine     hydrochloride when given together with carboplatin, etoposide, and rituximab in treating     patients with diffuse large B cell lymphoma or Hodgkin lymphoma that has come back after a     period of improvement or has not responded to previous treatment. Drugs used in chemotherapy,     such as bendamustine hydrochloride, etoposide, and carboplatin, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Monoclonal antibodies, such as rituximab, may block cancer growth by targeting     certain cells. Giving bendamustine hydrochloride together with carboplatin, etoposide, and     rituximab may kill more cancer cells.   "
252786|NCT01165125|"     A randomized two-way crossover study to determine whether concomitant administration of CYP     P450 3A4 inhibitor ketoconazole and fluticasone furoate/GW642444M combination significantly     increases the systemic effects and exposure to repeat dose fluticasone furoate and/or     GW642444 in healthy subjects. Key assessments will include blood potassium, heart rate, blood     pressure, QTc, serum cortisol and pharmacokinetic parameters, and safety including vital     signs, ECGs, adverse event monitoring and laboratory safety tests, including blood glucose.   "
252787|NCT01165138|"     The purpose of the study is to compare the efficacy and safety of fluticasone     furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder     both administered once daily in adolescent and adult subjects 12 years of age and older with     persistent bronchial asthma over a 12 week treatment period.   "
253200|NCT01164124|"     The overall purpose of this research is to test whether adding a supplement to the feeding of     extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will     help him/her achieve full feeding faster and achieve better weight gain.   "
252788|NCT01165151|"     The present study will assess whether the size of treatment groups (groups of 10 vs. 30     participants) affects short- and long-term weight loss. It is hypothesized that participants     assigned to a small group will exhibit similar short-term and long-term weight losses (i.e.,     weight loss at months 6 and 12) as compared to those assigned to a large group.   "
252789|NCT01165164|"     The purpose of this study is to describe the night-time use of an investigational lubricant     eye drop.   "
252790|NCT01165177|"     The purpose of this observer-blind study is to evaluate the efficacy, safety and     immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50     years.      Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted     concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both     studies combined will be conducted contingent on each study achieving its objectives. The     protocol posting of study ZOSTER-022 also deals with the outcome measures related to the     pooled analysis.   "
252791|NCT01165190|"     Mitochondrial dysfunction in skeletal muscle results in decreased muscle fatty acid     oxidation, leading to conversion of fatty acids into triglycerides and its accumulation     inside the muscle tissue. Moreover, in adipose tissue mitochondrial dysfunction results in     decreased fatty acid oxidation and triglyceride synthesis, leading to increased circulating     fatty acid concentrations, which in turn also leads to lipid accumulation inside muscle     tissue. Lipid accumulation inside muscle tissue interferes with the insulin signaling pathway     and causes insulin resistance. Mitochondrial dysfunction in both tissues has therefore been     proposed to play an important role in insulin resistance in humans.      Pioglitazone, a thiazolidinedione, is an FDA approved medication for the treatment of type 2     diabetes. It improves muscle insulin sensitivity at least in part by lowering intramuscular     lipid concentrations but the mechanism by which this occurs is unclear. In the present study,     we shall therefore test the hypothesis that pioglitazone improves mitochondrial function in     muscle and adipose tissue in humans who are insulin resistant.   "
252795|NCT01165242|"     The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK     Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through     25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK     134612 vaccine.   "
252796|NCT01165255|"     The study is an extension of earlier work based on a retrospective epidemiologic study of     infants born to women who were exposed to bupropion in their estimated first trimester of     pregnancy using data from a large US health plan affiliated with i3 Drug Safety (Clinical     study ID WWE113694) (Cole JA, Oh KS, Chiang CC, Walker AM, Haight BR, Modell JG. Bupropion in     pregnancy and the prevalence of congenital malformations Pharmacoepidemiology and Drug     Safety, 2007; 16: 474-484). The cohorts developed for the earlier work consisted of all     infants born to women exposed to bupropion during the estimated first trimester and outside     the first trimester, and a random sample of infants born to women exposed to other     antidepressants during the first trimester between 01 January 1995 and 30 September 2004. The     objectives for this study include refining of both the original first trimester bupropion     cohort and the original bupropion outside the first trimester cohort into mono-therapy and     mono- or poly-therapy. Exposure to other antidepressants during the first trimester will also     be refined into mono-therapy and mono- or poly-therapy. With input from pediatric cardiology     expert, lists of specific cardiovascular malformations and malformation groupings will be     created. The groupings will be created among the refined first trimester bupropion cohort as     well as in two comparison cohorts of bupropion outside the first trimester and first     trimester antidepressant use (mono-therapy and mono-or poly-therapy). The prevalence in each     cohort will be calculated as the number of infants with a specific cardiovascular     malformation divided by the number of live born infants. Prevalence will be reported per     1,000 infants. Confidence intervals will be calculated using Wilson's approximation to exact     binomial intervals when the number of cases is five or greater and exact binomial intervals     when the number of cases is fewer than five. The appropriateness of further calculations will     be evaluated. Where numbers permit, adjusted odds ratios for specific cardiovascular     groups/malformations will be calculated and if appropriate, stratified according to maternal     dispensing of medications suspected to be teratogenic. The following comparisons, if numbers     permit, will be performed: 1) bupropion first trimester mono-therapy cohort versus other     antidepressant first trimester mono-therapy cohort; 2) bupropion first trimester mono- or     poly-therapy cohort versus other antidepressant first trimester mono- or poly-therapy cohort;     3) bupropion first trimester mono-therapy cohort versus bupropion outside of first trimester     mono-therapy cohort, and 4) bupropion first trimester mono- or poly-therapy cohort versus     bupropion outside of first trimester mono- or poly-therapy cohort. Adjusted odds ratios will     be calculated through a generalized estimated equations form of multivariate logistic     regression to account for births associated with multiple infants. The same covariates     identified in the original study will be included in this re-analysis. Covariates included:     diagnoses of bipolar disorder and eclampsia within one year before delivery; dispensings of     lithium, phenytoin, and fluconazole within one year before delivery through the end of the     first trimester; and the number of physician visits within 10 to 12 months before delivery,     maternal age, geographic region of the health plan, and infant gender. If generalized     estimating equation form of the logistic regression model does not converge, adjusted odds     ratios will be presented from a conventional multivariate logistic model. If the conventional     multivariate logistic model does not converge, only the crude odds ratio will be presented.   "
252797|NCT01165268|"     It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the     renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.   "
252798|NCT01165281|"     The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as     JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone     Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant,     tumor-related cancer pain.   "
252799|NCT01165294|"     The objective of this study is to develop an exploratory design for future Proof-of-Concept     trials which reliably and accurately measure the central nervous system (CNS) effects of     potentially new drugs that oppose the effects of ketamine at a subanesthetic dose level given     to healthy volunteers. A functional magnetic resonance imaging (fMRI) and     electroencephalogram (EEG) performed simultaneously during a ketamine challenge will register     the effects triggered by Ketamine.   "
252842|NCT01165853|"     The purpose of this study is compare the effects of consuming glucose- and fructose-sweetened     beverages on appetite, body weight, body fat, and the amount of energy the body burns as well     as effects on blood pressure, hormones, blood triglycerides and cholesterol, and the body's     sensitivity to the insulin.   "
252800|NCT01165307|"     Excessive menstrual loss (menorrhagia) is a common condition that affects women of     reproductive age, and can result in anemia, chronic fatigue and lost wages from work. The     traditional first line management involves treatment with oral contraceptives or     non-steroidal anti-inflammatory agents. Many women ultimately undergo hysterectomy, a major     operative procedure associated with increased costs, loss of feeling of womanhood,     debilitating complications and on rare occasions, death.      The newer global endometrial ablation (GEA) devices allow the destruction of the endometrial     lining, without the removal of the uterus, in an ambulatory surgery setting. GEA offers a     safe and effective alternative to hysterectomy with minimal risks and without unpleasant     side-effects.      Presently, global endometrial ablation is offered as an alternative to hysterectomy, after     medical intervention has failed. This study will determine the role of global endometrial     ablation in the initial management of menorrhagia. Women seeking treatment for menorrhagia     will be randomized to either the medical treatment arm or the global endometrial ablation     arm.      This study will be the first to compare clinical efficacy and costs between oral     contraceptive pills and global endometrial ablation in the initial management of menorrhagia     and could potentially change the management of menorrhagia and impact millions of women who     suffer from this condition.   "
252801|NCT01165320|"     The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in     Japanese children and adolescents with documented Candida or Aspergillus infections.   "
252802|NCT01165333|"     The aim of the study is to determine the safety of Cilengitide in combination with radiation     therapy.   "
252803|NCT01165346|"     Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.   "
252804|NCT01165359|"     Hepatitis C (HCV) is a disease that affects the liver. ITX 5061 is a new medication that is     being tested to treat HCV. This study will evaluate the safety of ITX 5061 and examine     different doses of the medication to evaluate which dose is the most effective at lowering     the amount of HCV in the blood.   "
252805|NCT01165372|"     Background: There are worrying signs from Western Cambodia that parasitological responses to     artesunate containing treatment regimens for uncomplicated falciparum malaria are slower than     elsewhere in the world. Delayed parasite clearance and unusually high failure rates with     artesunate-mefloquine have been reported. These antimalarials are central to current     treatment strategies and spread of significant resistance outside this area would be a global     disaster. Radical containment measures are needed. In this context there is an urgent need to     proceed quickly to investigate whether there is any evidence of resistance to artemisinin     derivatives in Vietnam.      Objective: The primary objective is to assess the slope of the decline in the log     parasitemia-time curve in patients treated with artesunate 2mg/kg/day, artesunate 4mg/kg/day     or dihydroartemisinin-piperaquine once daily, and to compare the results of this study to the     pharmacokinetic results and to the recent data from patients in Cambodia and Thailand treated     with equivalent therapies.      Methods: The trial will be conducted in Phuoc Long Hospital, Binh Phuoc Province, Vietnam.     The participants will be febrile patients (aged > 10 years) with slide confirmed     uncomplicated P. falciparum infection. Patients will be treated with either artesunate     2mg/kg/day, artesunate 4mg/kg/day or dihydroartemisinin-piperaquine once daily for 3 days.     Patients on artesunate therapy arms will then receive 3 days of treatment with     dihydroartemisinin-piperaquine with dosages according to the national guidelines. Clinical     and parasitological parameters will be monitored over a 42-day follow-up period. The     pharmacokinetic characteristics of artesunate and dihydroartemisinin will be assessed by     using a population pharmacokinetic modeling.   "
252806|NCT01165385|"     The aim of this research is to evaluate the potential interest of an association of     Pazopanib, a multi-tyrosine kinase inhibitor, and cisplatin.      As cisplatin has marketing approval for several cancers (ovarian, testicle, bladder,     esophagus, endometrium, lung, stomach, head and neck cancer (HNC)), and in order to have a     rapid evaluation of this combination, we will evaluate the combination in any patient whose     tumors is known to be sensible to cisplatin (except tumors at risk of bleeding).      This study is a classical phase 1 trial of pazopanib and 3-weekly cisplatin association. It     will allow for optimal dose selection and pharmacokinetic analysis. It is planed to include     around 38 patients, enriching the optimal tolerated regimen (OTR) level only with a cohort of     triple negative breast cancer patients. If the association is proven to be feasible, we will     then move to a specific phase II study in triple negative breast cancer patients.   "
252807|NCT01165398|"     An estimated 250,000 cases of central line-associated bloodstream infections occur in US     hospitals annually, and an estimated 30,000 to 62,000 patients die as a result, the marginal     cost of which to the health-care system is approximately $25,000 per episode. Inconsistent     and outdated clinical practices have been identified as key causative factors. In order to     improve overall healthcare delivery and outcomes, current and future healthcare professionals     need to complement their clinical skills with systems-based skills. Specific to the problems     of central lines, during a 2005 chart review of institutional patient safety issues, a LVHN     internal quality committee found multiple cases involving the insertion of central lines,     including cases involving arterial placement and malposition. The internal quality committee     review revealed that newer residents were primarily involved in these cases. As a result of     the committee's findings and review of the literature, a standardized Central Line Access and     Placement course was designed as part of the incoming residents'orientation process. This     study's goal was to contribute to the knowledge-base of health professional education and to     build a sustainable model for one set of learning and development interventions, with the     expectation that findings will have broad relevance for patient safety initiatives, health     professional training and development programs, and healthcare delivery improvement.   "
252843|NCT01165866|"     Is intravenous metoclopramid as effective as intravenous ondansetron in the treatment of     persistent vomiting in patients with acute gastroenteritis.   "
252844|NCT01165879|"     The EUM100pro (Electrical Uterine Monitor)is a uterine contraction monitor which measures     uterine contractions based on the electrical activity of the uterine muscle.The study will     compare the EUM100pro measurements to the already existing uterine contractions monitors     (tocodynamometer and Intra Uterine Pressure Catheter) in pregnant women with complaints of     uterine contractions.   "
252845|NCT01165892|"     The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in     magnetic resonance imaging (MRI).   "
252808|NCT01165411|"     It has been estimated that 90% of bloodstream infections associated with catheters, are due     to CVCs, and that 500 to 4,000 patients in the United States die annually due to these     bloodstream infections. The risk of central line associated bloodstream infections is     typically expressed as the number of line infections per 1000 catheter days. This study's     goal is to develop a uniform CL protocol, updated practice guidelines based on current     evidence, and a standard procedural checklist based on CL care bundles recommended by the     Institute for Healthcare Improvement. A secondary goal is to create a CL registry to capture     and store data relevant to each CL placed throughout the institution. This registry will     provide a wealth of data on CL insertions and complications that may be used as a valuable     source of information for quality assurance, performance improvement, and research. With the     knowledge and information obtained through this registry, educational offerings can be     created, and a standardized institutional process for CL insertion can be developed.   "
252809|NCT01165424|"     Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center,     open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be     administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a     dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal     representatives) provided consent to continue treatment beyond 12 weeks will receive     treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal     symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse     events and trial procedure-related AEs will be reviewed 30 days after the end of the     follow-up.   "
252810|NCT01165437|"     Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD     are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is     the ratio of ankle pressure to arm pressure after measurement of blood pressures in the arms     and legs using a Doppler device. The need for dedicated equipment and trained personnel,     along with the time required to perform the test, have been identified as barriers to     widespread implementation of ankle-brachial index screening. The use of automated     oscillometric devices for blood pressure measurement has been applied to leg pressure     measurement and determination of the ankle-brachial index with variable success. It will be     beneficial to investigate a reliable oscillometric-based procedure that can accurately     measure leg pressures for the ankle-brachial index across the entire spectrum of PAD     severity.      In a previous pilot study completed in 2009 (IRB 08-823), the investigators gathered data     from N=60 subjects which allowed for mathematical analysis of oscillometric waveforms derived     from the lower extremities as compared to Doppler-based measurements of blood pressure. We     used signal processing analysis and regression techniques to develop a two-step algorithm     which will allow for accurate interpretation of oscillometric waveforms in normal/mild vs.     moderate/severely diseased limb and accurate calculation of ankle pressure across the     spectrum of peripheral artery disease severity.      This proposed project will validate this novel oscillometric ABI algorithm in a population of     patients who have been identified as at risk for PAD and for whom screening ABI has been     recommended by multiple professional organizations (AHA/ACC and American Diabetes     Association). Arm, ankle, and toe pressure measurements will be made in the supine position     using Doppler, oscillometric methods, and a photoplethysmographic sensor. The ankle-brachial     index and toe-brachial index will be calculated.   "
252811|NCT01165450|"     The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with     persistent corneal epithelial defects (PED) resulting from corneal epithelial debridement     during diabetic vitrectomy surgery, HSV keratitis, HZV keratitis, corneal burns, post-PRK, or     post-corneal transplant surgery.   "
252821|NCT01165580|"     This open label study will assess the pharmacokinetics and the safety and tolerability of     Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant     patients < 4 months of age.   "
252822|NCT01165593|"     The purpose of this study is to gather information about the size and shape of patients'     hearts in order to design a device.   "
252823|NCT01165606|"     This study aimed to determine the impact of providing chest physiotherapy on the duration of     mechanical ventilation, intensive care length of stay, intensive care and hospital mortality     in mechanically ventilated patients.   "
252812|NCT01165463|"     This is second-generation study based on results from ACTIVE (Advanced Cognitive Training for     Independent and Vital Elderly). This four-arm study is known as IHAMS (the Iowa Healthy and     Active Minds Study). The investigators will formally test from an intent-to-treat perspective     for differences on the primary and secondary outcomes based on whether participants were     randomized to the basic on-site speed of processing training (SOPT) group (G1), to the     on-site basic SOPT plus subsequent booster-training group (G2), to the basic at-home SOPT     group (G3), or to the basic attention-control group (G4). Basic training involves 10 hours of     either the SOPT or attention-control training during the first 6 weeks of participation.     Booster-training involves 4 additional hours of SOPT training at 11 months of participation.   "
252813|NCT01165476|"     The purpose of this study is to compare the bioavailability of a single 1mg dose of     treprostinil diethanolamine sustained release (SR) tablets manufactured by two independent     facilities.   "
252814|NCT01165489|"     Laryngomalacia is the most common congenital malformation of the larynx. It results from     abnormal prolapse of supraglottic structures during inspiration. Symptoms usually appear     within the first 2 weeks of life. Its severity increases in up to 6 months. 15-60% of infants     with laryngeomalacia have synchronous airway anomalies.   "
252815|NCT01165502|"     The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue     CM3.1-AC100 after repeated subcutaneous (sc) doses.   "
252816|NCT01165515|"     Endostatin, a 20-kDa cleavage product of collagen XVIII, is a component of the extracellular     matrix expressed in the basement membrane. As a potent inhibitor of angiogenesis, endostatin     induces endothelial cell apoptosis and diminishes cell migration, adhesion and proliferation.      Endostatin may stop the progression of atherosclerosis. Atherosclerotic heart disease     involves unwanted tissue growth. By cutting off the blood supply from a plaque the likelihood     of plaque rupture may eventually be reduced. Recent data indicates that the loss of collagen     XVIII/endostatin is related to the enhancement of neo-vascularization and vascular     permeability in atherosclerosis. Plaque neo-vascularization strongly correlates with the     regional content of inflammatory cells. Furthermore, increased vascular permeability enhances     lipid accumulation in the vessel walls, hence increasing foam cells.      Therapeutic angiogenesis is a most promising strategy for the treatment of myocardial     infarction. However, it remains unknown if and how endogenous angiogenesis inhibitors, such     as endostatin, regulate angiogenesis in myocardial infarction. Rat models showed that after     myocardial infarction endostatin neutralization displayed adverse left ventricular remodeling     and severe heart failure compared with controls. Although angiogenesis was increased, tissue     remodeling and interstitial fibrosis were further exaggerated in post-myocardial infarction     hearts by endostatin neutralization.      However, several studies suggest that endostatin may locally modulate coronary collateral     formation by inhibiting collateral vessel formation in patients with ischemic heart disease.      During treadmill exercise tests in healthy volunteers a significant increase in circulating     endostatin levels can be observed. Exercise induces angiogenesis in cardiac and skeletal     muscles by decreasing endostatin in the muscle tissues to increase blood flow to these     metabolically active tissues. Thereby endostatin is released into the general circulation.      In summary, endostatin might be a new weapon to fight against atherosclerotic progression by     inhibiting neo-vascularization of atherosclerotic plaques.   "
252846|NCT01165905|"     Treatment of cancer is often more effective when two or more drugs are used together. For     example, when gemcitabine, an approved drug, and ON 01910.Na, a new investigational     anti-cancer drug, are used together to treat cancer cells in laboratory animals, there is     more inhibition of the growth of the cancer cells compared to either drug used by itself.     These results offer promise that gemcitabine and ON 01910.Na could be used to treat cancer in     patients. However, before studies that seek to find out if gemcitabine and ON 01910.Na is an     effective combination in patients can be done, doctors must first know what is largest, safe     dose of ON 01910.Na that can be used in combination with gemcitabine and what is the best     regimen to use. This study is designed to answer that question.   "
252817|NCT01165528|"     Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care     Unit (RICU) of Post Graduate Institute of Medical Education And Research (PGIMER),Chandigarh.     The study is approved by the Institute Ethics committee. In view of lack of previous outcome     data in such patients, all patients requiring RICU admission for acute respiratory distress     syndrome(ARDS) between January 2010 and June 2011 are being enrolled in this pilot study.      The patients meeting the aforementioned criteria will randomly assigned to ventilation with     assist control mode ventilation (ACMV group) as per the ARDSnet strategy or adaptive support     ventilation (ASV group). Being the first RCT of its type, patients will be first stabilized     on ACMV for 1 hour to determine the adequate minute ventilation. The randomization sequence     will be computer generated. The assignments will placed in sealed opaque envelopes and each     patient's assignment was made on admission to the RICU by the attending physician. Blinding     of treatment is not possible.      All patients will be ventilated only by Galileo Gold ventilators (Hamilton medical systems,     Bonaduz, Switzerland). Patients randomized to the ACMV group will be ventilated according to     low tidal volume strategy of 6ml/kg with Fio2/PEEP as per ARDSnet table to achieve a     saturation between 88-95% with the lowest possible Fio2 to maintain plateau pressures < 30     cms H2o and PH > 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory     rate to 35/ min to achieve the above said goals11.These patients will be weaned as per     standard protocol of spontaneous breathing trial of 30 minutes once they are recognized     eligible as per statement of the sixth International consensus conference on weaning.   "
252818|NCT01165541|"     The purpose of the study is to test whether taking two medicines (quetiapine and mirtazapine)     is better for helping people to decrease drinking than taking one medicine alone     (quetiapine).   "
252819|NCT01165554|"     To determine the level of association between quantitative regional estimates of brain uptake     of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain levels     of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.   "
252820|NCT01165567|"     Background:      Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased     morbidity and mortality, particularly in patients with chronic renal insufficiency. Although     some agents including hydration with saline are being prescribed to prevent renal     deterioration in these high risk patients, their efficacy is not clear defined and debatable.     Therefore additional prophylactic pretreatments are needed.      Methods/Design:      Present study aims to investigate differences in occurrence of CIN after sarpogrelate     premedication in patients with chronic kidney disease (CKD). 268 participants, aged 20-85     years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to     one of two conditions: (i) a routine treatment without sarpogrelate group (ii) routine     treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day). The primary outcome is the     occurrence of CIN during 4 weeks after receiving contrast agent.      Discussion:      As of May 2010, there were no registered trials evaluating the therapeutic potentials of     sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal function     and occurrence of CIN, it will provide a safe, easy and inexpensive treatment option.   "
252824|NCT01165619|"     In this study, we will measure levels of reproductive hormones and metabolic markers in     subjects with isolated GnRH deficiency disorders and compare them to healthy control     populations. Our goals are (1) to chart the range of hormonal and metabolic biomarkers in     healthy subjects and those with reproductive disorders and (2) to correlate reproductive and     metabolic phenotypes with genetic changes within patients with reproductive disorders and     healthy controls.   "
252825|NCT01165632|"     RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may     help in guiding surgery and radiation therapy and allow doctors to plan better treatment.      PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning     surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade     malignant glioma   "
252826|NCT01165645|"     RATIONALE: HIV protease inhibitors, including Lopinavir/Ritonavir have intrinsic     anti-apoptotic properties in addition to their anti-viral effect on HIV. This anti-apoptotic     effect may boost the immune system to help the body create a better immune response to     vaccines. PURPOSE: This randomized clinical trial studies giving lopinavir and ritonavir     together in improving immune response to vaccines in patients with complete remission     following a bone marrow transplant for Hodgkin lymphoma.   "
252827|NCT01165658|"     The goal of this clinical research study is to study the safety of giving larger daily doses     of proton radiation therapy than the standard dose levels given to treat lung cancer.     Researchers want to find the highest daily dose of proton radiation that can be given without     having to stop therapy due to side effects.   "
252847|NCT01165918|"     The purpose of this study is        1. To generate human embryonic stem cells lines (hESC) lines        2. Study of the factors that contribute to differentiation towards germ cell.   "
252848|NCT01165931|"     The aim of the study is to assess the effects of intracoronary Riociguat on coronary blood     flow in subjects with coronary artery disease and to compare this effect with the     intracoronary nitroglycerin, a coronary vasodilator widly used to treat patients with     coronary artery disease.   "
252873|NCT01166256|"     Acute hypoxemic respiratory failure may require invasive mechanical ventilation. However,     invasive mechanical ventilation is associated with a variety of complications. Non-invasive     ventilation has been presented as an alternative treatment but controversy remains. The     investigators hypothesize that high-flow nasal cannula system is effective enough to prevent     intubation in acute hypoxemic respiratory failure and not inferior to non-invasive     ventilation.   "
252828|NCT01165671|"     Treatment standard for patients with primary glioblastoma (GBM) is combined radiochemotherapy     with temozolomide (TMZ). Radiation is delivered up to a total dose of 60 Gy using photons.     Using this treatment regimen, overall survival could be extended significantly however,     median overall survival is still only about 15 months.      Carbon ions offer physical and biological advantages. Due to their inverted dose profile and     the high local dose deposition within the Bragg peak precise dose application and sparing of     normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase     relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on     the GBM cell line as well as the endpoint analyzed. Protons, however, offer an RBE which is     comparable to photons.      First Japanese Data on the evaluation of carbon ion radiation therapy showed promising     results in a small and heterogeneous patient collective.      In the current Phase II-CLEOPATRA-Study a carbon ion boost will be compared to a proton boost     applied to the macroscopic tumor after surgery at primary diagnosis in patients with GBM     applied after standard radiochemotherapy with TMZ up to 50 Gy. In the experimental arm, a     carbon ion boost will be applied to the macroscopic tumor up to a total dose of 18 Gy E in 6     fractions at a single dose of 3 Gy E. In the standard arm, a proton boost will be applied up     to a total dose 10 Gy E in 5 single fractions of 2 Gy E.      Primary endpoint is overall survival, secondary objectives are progression-free survival,     toxicity and safety.   "
252829|NCT01165684|"     This trial is conducted in Europe, and North and South America. The aim of this clinical     trial is to investigate if the two treatments are equally effective.   "
252830|NCT01165697|"     Fabry disease, an x-linked recessive lysosomal storage disease (LSD) is commonly recognized     as a cause of renal failure in involved men and more recently recognized in women too. Women     are involved in significant numbers and with complications, as are men, of vascular disease.     This manifests as unexpected strokes in young adults. We have morphologic evidence that     storage-endotheliopathy induced microvascular disease is the cause of cardiopathy and of     cryptogenic strokes, and that storage endotheliopathy starts in early life, probably before     birth. Based on our earlier work with other endotheliopathies such as diabetes mellitus,     Susac syndrome, and hypertension, we will find and study patients using unique methods,     neuro-retinal fluorescein angiography (NRFA), that we have developed for this purpose. These     methods include NRFA to demonstrate capillary perfusion in the optic nerve head and retinal     quadrants. We anticipate, based on our earlier experience with other endotheliopathies, that     we will show more vascular pathology earlier than previously reported. Using epidemiologic     and genetic tools we will find more patients than previously known or expected. It will offer     opportunity for earlier diagnosis, prognosis, and response to enzyme replacement therapy.      We hypothesize that Fabry disease is a poorly recognized and poorly characterized cause of     microvascular disease and cryptogenic strokes in young women and men. Neuroretinal capillary     perfusion abnormalities in Fabry disease will be predictive of equivalent vascular disease in     kidney, heart, brain and other organs, and further that it will be responsive to change     induced by enzyme replacement therapy treatment.   "
252831|NCT01165710|"     The ORBIT-AF registry will be a multicenter, prospective outpatient disease registry to     identify real world treatment patterns of atrial fibrillation. The registry will describe     this patient population with regards to demographics, clinical factors, risk stratification,     and geographic regions. In particular, attention will be focused on the utilization,     effectiveness, and safety of antithrombotic therapies in the prevention of stroke. The     registry is designed to identify reasons and risk factors for non-receipt of anticoagulation     (AC) therapy, as well as reasons why AF patients who are prescribed AC therapy do not take     them.   "
252832|NCT01165723|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of PF-04472429 administered intravenously to healthy adult volunteers.   "
252834|NCT01165749|"     The long term health and cardiovascular benefits of a regular exercise program have been     well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e.     walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy     (HCM). However, data on potential benefits of recreational exercise, useful parameters for     risk stratification, and methods of devising individual exercise prescriptions are completely     lacking. The specific aims of this study are: 1) to devise a safe moderate intensity exercise     training program in patients with HCM, and 2) to determine whether exercise training improves     ability to perform activities and tasks, heart size and function, and quality of life in     patients with HCM.   "
252835|NCT01165762|"     The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone     marrow Transplantation are enrolling patients into a research study to determine if donor     stem cells given after a living related one Haplotype match kidney transplantation will     change the immune system such that immunosuppressive drugs can be completely withdrawn.   "
252836|NCT01165775|"     We hope to clarify how betamethasone affects glucose levels in the mother in the days after     receiving the drug. This understanding will hopefully allow us to better anticipate the risk     of maternal hyperglycemia and therefore establish more appropriate monitoring of maternal     glucose to prevent maternal and neonatal complications of hyperglycemia.   "
252837|NCT01165788|"     1. To explore specific aspects of social adaptation such as social connectedness,          occupational outcomes and family relationships in lymphoma patients after autologous          blood or marrow transplantation (BMT).        2. To investigate how social adaptation varies with time lapsed since BMT and with the life          stage as determined by patient?s age. Understanding both the positive and negative          aspects of cancer and cancer therapy leads to opportunities to promote adaptive          strategies.   "
252838|NCT01165801|"     The purpose of this study was to find out if in patients with non-exudative age-related     macular degeneration (AMD), randomly assigned to cataract surgery, any AMD size progression     or progression to exudative AMD could be detected 6 months after surgery.   "
252839|NCT01165814|"     Oral naproxen might be more efficacious for post-cesarean pain-control and have better     side-effects profile than oral tramadol.   "
252840|NCT01165827|"     1. Research aims           The increasing prevalence of severe aortic valve defects is a corollary to increases in          life expectancy. For many years, surgical valve replacement with extracorporeal          circulation has been the gold standard in the treatment of severe aortic valve diseases.          Every year, about 12,000 patients in Germany receive isolated aortic valve surgery.          Several alternatives to established procedures have recently emerged:             -  V-TAVI, vascular transcatheter aortic valve implantation and             -  A-TAVI, apical transcatheter aortic valve implantation. For some time, percutaneous               balloon valvuloplasty has been used as a palliative measure for specific patients.           New developments have triggered assumptions that there will over the coming years be a          certain reorientation to the treatment of patients with aortic valve defects. In a          positioning paper published jointly by the German Cardiac Society (DGK) and the German          Society for Thoracic and Cardiovascular Surgery (DGTHG), there is a consensus that these          new techniques can be used on patients who have either contraindications against          conventional surgery or who are at high risk of preoperative mortality, e.g. due to          severe comorbidities.           As there is as yet only limited experience in this field and neither randomised trials          nor long-term-results are available, the use of new implantation techniques is therefore          not recommended for younger patients or patients without comorbidities. There is          accordingly an urgent need for any introduction of this innovative medical procedure to          be stringently monitored according to scientific principles. The goal of the planned          Germany Aortic Valve Register is to evaluate the new treatments from the point of view          of benefits und risks with respect to the gold standard of conventional surgery, with a          view to compiling evidence-based indication criteria. The register will furthermore          allow for the first time a comparison of various operative procedures, such as Ross          procedure, David procedure and various mechanical or biological aortic valve implants.        2. Rationale of the study design Randomised trials in controlled environments are          considered best scientific practice for verifying the efficacy of a new method. The          disadvantage is that only a small part of potential patients can be included in the          trial, and results therefore reflect only a small section of the real world.          Furthermore, a randomised study design is for ethical reasons not an acceptable approach          to all questions, especially when contraindications exist for a certain branch of          treatments and the spectrum of treatments is to be expanded. Nevertheless, new          procedures have to be critically and scientifically analysed if the risk-benefit ratio          is to be accurately determined. National heath authorities therefore request register          data in addition to controlled trials in order to verify the safety and efficacy of new          procedures across larger patient populations.        3. Objectives             1. Description of structure, process and outcome quality for the various techniques of               aortic valve therapies             2. Definition of indication criteria (e.g. through scoring systems)             3. Collection of information on quality and safety for special medical devices             4. Evaluation of quality of care on the level of participating centres with a view to               increasing quality             5. Health economic evaluation of the applied treatments        4. Study design Prospective, controlled, multicenter register study   "
252849|NCT01165944|"     Post-transplant diabetes mellitus (PTDM) develops in up to 30% of patients undergoing solid     organ transplantation. This disease is difficult to treat as the levels of glycemia fluctuate     in response to variations in doses of steroid and other immunosuppressive agents. At the same     time, poorly controlled hyperglycemia affects negatively graft function and survival as well     as on the ability of the immunocompromised host to fight infections. The investigators     hypothesize that the addition of Pramlintide (Symlin) to the management of patients with PTDM     would help patients with post-transplant diabetes attain better control at the critical time     of titration of immunosuppressive regimens. The primary objective of this proposal is to     improve glycemic control of diabetes with Pramlintide in patients with post-transplant     diabetes at 3 and 6 months of therapy.   "
252850|NCT01165957|"     The purpose of this study is to determine the amount of polyethylene wear associated with     knee replacement designs that incorporate either a fixed or mobile bearing. Tibial     polyethylene inserts retrieved from modular total knee replacements during revision     operations will be analyzed by obtaining micro-CT images of the retrieved inserts. The     components of total volumetric polyethylene loss, including wear associated with the medial     articular, lateral articular and backside regions of the insert be quantified by comparing     the worn insert with an unworn control. The investigators hypothesize that the fixed bearing     inserts where the polyethylene is locked to the metal baseplate will demonstrate more     volumetric wear than the mobile bearing inserts that are designed to slide or rotate on the     metal baseplate.   "
252851|NCT01165970|"     Symptomatic hyposalivation is associated not only with Sjögren`s syndrome or salivary gland     hypofunction in elderly patients, but also with medications containing antimuscarinic drugs,     chemo radiotherapy for head and neck carcinomas, and psychiatric disorders (Atkinson & Ava,     1994, Kielbassa et al., 2006).      Human saliva possesses important physiological functions in protecting and moistening the     oral hard and soft tissues (Piotrowski et al., 1992, ). Consequently, decreasing salivation     causes oral dysfunction and promotes severe oral side effects (reduced antibacterial     function, lack of remineralisation, reduced buffer capacity) (Tschoppe et al., 2010a). These     have been identified as being responsible for the rapid destruction of the dentition (Willich     et al., 1988). Saliva substitutes are frequently applied for relieving the symptoms in     patients suffering from hyposalivation (Hahnel et al., 2009, Nieuw Amerongen & Veerman, 2003,     Vissink et al., 2004). Besides the moistening and lubrication of the oral mucosa, these     products should also protect dental hard tissues. However, in vitro studies revealed that     some marketed products have only a neutral or even a demineralising potential on enamel as     well as on dentin (Kielbassa et al., 2001, Meyer-Lueckel et al., 2002, Smith et al., 2001,     Tschoppe et al., 2009). Inorganic ions such as calcium, phosphates, and fluorides have been     added to saliva substitutes in order to enhance their remineralising property or minimize     their demineralising potential (Tschoppe et al., 2009). Furthermore, as most patients     suffering from hyposalivation are elderly people, recessions and subsequently exposed dentin     surfaces are very common. Since dentin is not as acid resistant as enamel, an earlier and     more severe demineralisation can be expected (Saunders & Meyerowitz, 2005).      Therefore, the current in situ study was performed to assess the effects of a demineralising     and a remineralising saliva substitutes on the mineralisation of dental hard tissues. It was     hypothesized that storage in Glandosane(cell pharm, Hannover, Germany) would not result in     pronounced mineral loss of dentin specimens, and that storage in Saliva natura would not     result in enhanced remineralisation when combined with a remineralising artificial saliva     (Saliva natura supersaturated with respect to relevant calcium phosphates; medac, Hamburg,     Germany) (H0). These null hypotheses were tested against the alternative hypothesis of a     difference.   "
252852|NCT01165983|"     The purpose of this research is to study and determine the effects of Aliskiren on blood     vessels and blood flow. The primary hypothesis is that Aliskiren will increase endothelial     function by 30% or more in comparison to the placebo group.   "
252853|NCT01165996|"     RATIONALE: Decitabine may help myelodysplastic cells become more like normal stem cells.     PURPOSE: This clinical trial studies differentiation therapy with decitabine in treating     patients with myelodysplastic syndrome.   "
252854|NCT01166009|"     The primary purpose of the Research Database is to have a comprehensive source of     observational data that can be used to study HSC transplantation.      A secondary purpose of the Research Database is to have a comprehensive source of data to     study marrow toxic injuries.      Objectives:      To learn more about what makes stem cell transplants work well, such as determining the     following:        -  how well recipients recover from their transplant        -  how recovery after a transplant can be improved        -  how access to transplant for different groups of patients can be improved        -  how well donors recover from the collection procedures   "
252855|NCT01166022|"     This study is being conducted to test whether exercise can be effectively used as an     intervention to treat Spinal Muscular Atrophy (SMA). In order to answer this question, the     investigators will enroll 14 subjects with SMA between ages 8 and 50 and ask them to complete     an 18 month training schedule. At some points subjects will be asked to closely follow a     specific training regimen and at other points they may be asked to exercise in the same     manner they do normally. The exercises they will be asked to perform include biking on a     stationary cycle and lifting hand weights. Subjects will be asked to come in to the clinic     seven times over the course of the study to perform tests. These tests include motor function     measures, a physical exam, questionnaires, a exercise capacity test which involves riding a     stationary bicycle, and test where the subject is asked to walk as far as they can in six     minutes. The main goal of the study is to see if the subjects who participate in the exercise     protocol have larger increases in the distance they can walk in six minutes than those who do     not.   "
252856|NCT01166035|"     This is a Phase 1/2, open-label, monocentric, dose-escalation study of lenalidomide in     combination with cetuximab in subjects with solid tumors. The primary objective is to     establish the maximum tolerated dose (MTD) of lenalidomide in combination with cetuximab in     patients with solid tumors including colorectal cancer (CRC), squamous cell carcinoma of the     head and neck (SCCHN) and non-small cell lung cancer (NSCLC).   "
252869|NCT01166204|"     Our group has shown that increasing the radiation dose to pre-specified normal tissue dose     constraints could lead to increased TCP with the same NTCP in patients with non-concurrent     and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a     prospective study in patients with stage I-III NSCLC, who are selected for high-dose     radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has     become standard, but the patterns of recurrence and the possibility for dose-escalation in an     individualised setting have never been investigated properly.   "
252870|NCT01166217|"     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The     primary purpose of this trial is to evaluate the relative bioavailability of three different     oral dose formulations of PF-04620110.   "
253439|NCT01173094|"     The purpose of this trial is to find out the appropriate way to treat DM patients with     critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of     femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.   "
252857|NCT01166048|"     Objective:      The objective of this study is to compare the efficacy of duloxetine in the treatment of     patients with chronic low back pain with a radicular component to placebo.      Study hypothesis:      Duloxetine is a new substance now in use for the treatment of neuropathic pain. It has proven     its efficacy in diabetic peripheral neuropathy and fibromyalgia in several trials. The     investigators therefore hypothesize that duloxetine will be efficacious in patients with     chronic low back pain and a radicular component.      Study Rationale:      Chronic low back pain is an extremely common diagnosis. However, therapeutic options for the     condition are limited and therapy remains difficult. Duloxetine has proven its efficacy in     patients with neuropathic pain and may also be useful in chronic low back pain. If the     investigators are able to show a benefit for patients in the duloxetine arm, the substance     may constitute a further treatment alternative in chronic low back pain.      Study Design:      Prospective, randomized, double-blind placebo-controlled cross over study. Patients will be     administered duloxetine for 4 weeks followed by a 2 week wash-out phase after which they will     be medicated with placebo for 4 weeks. A second group of patients will receive the medication     in reversed order. The primary study endpoint is constituted the weekly mean of VAS-Score in     the last week of each treatment period. Secondary endpoints are defined as use of rescue     medication, Beck Depression Inventory score, Health related Quality of Life SF-36 score and     side effects/adverse events.   "
252858|NCT01166061|"     Grass pollen allergens are universally recognised as a major cause of allergic diseases in     humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis.     Worldwide, at least 40% of allergic patients are sensitized to grass pollen allergens and     between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen.      ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine,     currently being developed for the treatment of grass allergy.      The purpose of the present study is to evaluate the safety and tolerability of multiple     ascending doses of ToleroMune Grass in subjects allergic to grass.   "
252859|NCT01166074|"     This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants     less than two years old.   "
252860|NCT01166087|"     The purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride     Delayed-Release Capsules, 90 mg and Prozac ® weekly under fed conditions.   "
252861|NCT01166100|"     The purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride     Delayed-Release Capsules, 90 mg and Prozac ® weekly under fasting conditions.   "
252862|NCT01166113|"     This study will evaluate if the combination of Pomalidomide, Cyclophosphamide and Prednisone     is safe and provides benefits in patients with multiple myeloma relapsed and/or refractory to     lenalidomide.   "
252863|NCT01166126|"     The purpose of this study is to find out how often two investigational drugs that are given     together will shrink the patient's tumor and how well they will prolong the time it takes     their tumor to grow. The investigators also wish to find out how they affect certain     substances in the patient's tumor and in their blood important for tumor growth. The     combination of these drugs is experimental, and has not been proven to help treat melanoma   "
252864|NCT01166139|"     A phase IIa open-label single center pilot study to assess the safety and efficacy of     Nilotinib in patients with Scleroderma.   "
252889|NCT01166464|"     The primary goal of this study is to use qualitative interviews and focus groups to aid us in     adapting a face-to-face smoking cessation intervention for delivery through text messaging.     After design is completed, the intervention will be pilot tested with a sample of young     adults (ages 18-35) who smoke. Final assessments will be conducted at 7 weeks (end of     treatment) and both 3 and 6 month follow up.   "
252890|NCT01166477|"     The Study will help to compare the Quality of Life for those HIV patients that are on     monotherapy with LPV/r Vs. triple therapy with a boosted protease inhibitor   "
252865|NCT01166152|"     The purpose of this study is to develop a new diagnostic method for developmental disorders     based on behavior recording during the interview of the subjects by medical staff as well     anonymous persons. The behavior recording by video camera will be accompanied by non-invasive     physiological recordings, including electroencephalogram (EEG), electrocardiogram (ECG),     electromyogram (EMG), and body temperature using infrared (IR) thermograph. Thus, the     physiologically relevant and the disorder correlated behavior parameters could be extracted     and used as new diagnostic markers. If necessary, the medical staff may take blood sample     from the subject before and after the interview. For the longitudinal study, the similar     interview and the recording of the same subject will be planned to evaluate the effect of the     medical and educational intervention. The investigators also examine the synergistic effect     of the intervention and the administration of the supplement (e.g., vitamin D, arachidonic     acid, coenzyme Q10 (CoQ-10)). The clinician may use Risperidone.   "
252866|NCT01166165|"     High blood pressure is related to increased risk of cardiovascular disease and death, and     accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a     seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is     more common during months where UVB radiation from the sun is absent, and vitamin D has been     associated with high blood pressure. This study will evaluate the effect of vitamin D     replacement during winter months on blood pressure and vasoactive hormones in patients with     high blood pressure.   "
252867|NCT01166178|"     This study is designed to evaluate the efficacy and safety of zoledronic acid 5 mg     intravenous (i.v.) relative to placebo in Multiple Sclerosis (MS) patients with osteoporosis     and to support the optimal use of zoledronic acid for this indication. Primary objective is     the change of Bone Mineral Density (BMD) at lumbar spine (L1-L4) and total hip region     assessed by T-Score at month 12 relative to screening as measured by Dual X-ray     Absorptiometry (DXA). This double-blind period will be followed by a 52-week open-label     treatment phase to assess long-term efficacy and safety of zoledronic acid in these patients.   "
252868|NCT01166191|"     The investigators' group was the first to perform a phase II trial in patients with limited     disease (stage I-III) small-cell lung carcinoma (SCLC) in which only the     fluorodeoxyglucose-positron emission tomography (FDG-PET) positive lymph nodes were     irradiated. In this trial, only 3% of isolated nodal failures were observed. However, all     patients in that study were treated with 3D conformal radiotherapy (3DCRT). At present, IMRT     techniques have become more standard in lung cancer. Because of the lower radiation dose to     the lymph nodes outside of the planning target volume (PTV) with IMRT, higher incidences of     isolated nodal failures may occur. In this trial, the investigators will investigate the     patterns of local relapse after IMRT with concurrent chemotherapy in patients with stage     I-III SCLC.   "
252871|NCT01166230|"     The study is intended to investigate whether the improved initial detection and resection of     bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix     (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences     compared to standard white light cystoscopy/TURB.   "
252874|NCT01166269|"     The purpose of the study is to try a new route for specific immunotherapy (SIT). The current     treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50     injections subcutaneously in the upper arm.      The investigators believe that there is additional effect if the allergen is injected     directly into the lymph node, since it is here, the allergen presentation is happening. The     trial has been performed in Switzerland with significant effect of only three injections of     grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).      The investigators would like to see what happens if the the dose is doubled, so the patients     will receive 6 injections all in all, with the same amount of allergen as the earlier study     (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note     their symptoms in a diary.      The patients will be divided into three groups using allocation:      1 group with 6 injections of allergen      1 group with 3 injections of allergen and 3 injections of placebo      1 group with 6 injections of placebo. The trial will be double blinded.   "
252875|NCT01166282|"     The purpose of this study is to evaluate the efficacy and safety of adalimumab given     subcutaneously every other week (eow) as compared to placebo in pediatric subjects with     Enthesitis Related Arthritis (ERA).   "
252876|NCT01166295|"     Post herpetic neuralgia (PHN) is an undertreated condition. It is a type of neuropathic pain     (NP), or pain caused by abnormal activity of sensory nerves. Its mechanisms are not fully     understood, and medication trials for PHN pain and other types of NP are frequently     unsuccessful.      There has been extensive investigation aimed at identifying and understanding the specific     mechanisms of NP. While some of these tests are inexpensive and easy to perform at the     bedside, many require expensive tools and highly equipped laboratory facilities. Further,     there is no standard method for assessment of pain in NP patients.      The investigators aim to test a Bedside Sensory Testing Kit (assessment for Neuropathic Pain)     on a small number of patients with PHN.      The purpose of the Kit is to identify mechanisms of pain. The goal of this research is to     design a way to classify patients with PHN based on what mechanisms are causing their pain,     since this may help predict the best medications for individual patients.   "
252877|NCT01166308|"     Treatment of patients with recurrent glioma includes neurosurgical resection, chemotherapy,     or radiation therapy. In most cases, a full course of radiotherapy has been applied after     primary diagnosis, therefore application of re-irradiation has to be applied cautiously. With     modern precision photon techniques such as fractionated stereotactic radiotherapy (FSRT), a     second course of radiotherapy is safe and effective and leads to survival times of 22, 16 and     8 months for recurrent WHO grade II, III and IV tumors.      Carbon ions offer physical and biological characteristics. Due to their inverted dose profile     and the high local dose deposition within the Bragg peak precise dose application and sparing     of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an     increase relative biological effectiveness (RBE), which can be calculated between 2 and 5     depending on the Glioblastoma (GBM) cell line as well as the endpoint analyzed. Protons,     however, offer an RBE which is comparable to photons.      First Japanese Data on the evaluation of carbon ion radiation therapy for the treatment of     primary high-grade gliomas showed promising results in a small and heterogeneous patient     collective.      In the current Phase I/II-CINDERELLA-trial re-irradiation using carbon ions will be compared     to FSRT applied to the area of contrast enhancement representing high-grade tumor areas in     patients with recurrent gliomas. Within the Phase I Part of the trial, the Recommended Dose     (RD) of carbon ion radiotherapy will be determined in a dose escalation scheme. In the     subsequent randomized Phase II part, the RD will be evaluated in the experimental arm,     compared to the standard arm, FSRT with a total dose of 36 Gy in single doses of 2 Gy.      Primary endpoint of the Phase I part is toxicity. Primary endpoint of the randomized part II     is survival after re-irradiation at 12 months, secondary endpoint is progression-free     survival.   "
252878|NCT01166321|"     Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical     resection. With this approach, local control ranges between 50 and 70%, depending on     resection status. A series or smaller studies has shown that postoperative radiotherapy in     this patient population can increase progression-free survival, which translates into     increased overall survival. However, meningiomas are known to be radioresistant tumors, and     radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.      Carbon ions offer physical and biological characteristics. Due to their inverted dose profile     and the high local dose deposition within the Bragg peak precise dose application and sparing     of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an     increased relative biological effectiveness (RBE), which can be calculated between 2 and 5     depending on the cell line as well as the endpoint analyzed.      First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion     radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results     are promising.      Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the     macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the     clinical target volume (CTV) in patients with atypical meningiomas after incomplete resection     or biopsy.      Primary endpoint is progression-free survival rate, secondary endpoints are overall survival,     safety and toxicity.   "
252879|NCT01166334|"     Would you like to quit smoking?      Seattle's Fred Hutchinson Cancer Research Center is launching a new study that may be able to     help. Participants who enroll in this study will be randomly assigned by computer (like     flipping a coin) to one of two online programs. The goal of this study is to learn which of     these programs is the most effective at helping people stop smoking. Findings from this study     will be used to help build more effective online smoking cessation programs in the future.      Participants in both of the smoking cessation programs used in this study will receive:        -  Interactive tools for dealing more effectively with urges to smoke        -  Step-by-step guides for quitting smoking        -  Personalized plans for quitting and remaining smoke-free        -  Electronic links for reaching one-on-one expert help for quitting      Participants will be asked to complete online questionnaires, including a brief three-month     follow-up survey.      There is no cost for participating in this study.      To enroll in this study or for more information, please visit www.webquit.com.      This study is being conducted by Seattle's Fred Hutchinson Cancer Research Center     (www.fhcrc.org), a world leader in advancing the prevention, diagnosis and treatment of     cancer. The principal investigator for the WebQuit smoking cessation study is Dr. Jonathan     Bricker, a faculty member at both the Hutchinson Center and at the University of Washington     in Seattle.   "
252880|NCT01166347|"     The purpose of this study is to determine the safety and effectiveness of the HeartWare     Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left     ventricular failure who have received and failed optimal medical therapy, and who are     ineligible for cardiac transplantation.   "
253440|NCT01173107|"     A pilot study for PK/PD parameter of colchicine in Chronic kidney disease patient.   "
252881|NCT01166360|"     Growth determination factor 15 (GDF-15) and high sensitive troponin-t (hsTnT) are emerging     humoral markers for risk stratification in clinically stable heart failure patients and in     patients with stable coronary artery disease. No data are available about the prognostic     value of these peptides in relation to mortality and morbidity in patients undergoing cardiac     surgery.      Primary objective of the present study is to test the hypothesis, that GDF-15 is superior to     a standard preoperative risk score, the additive Euroscore for the prediction of 30 day     mortality and postoperative morbidity in patients scheduled for cardiac surgery.      Secondary objectives are to test the predictive value of hsTNT, either alone, or in     combination with GDF-15 and if GDF-15 adds additional information to NTproBNP levels and     preoperative cerebral oxygen saturation (ScO2) levels.   "
252882|NCT01166373|"     Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for     OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study     and no new study treatment interventions will be given. Rather an enrollment intervention     will be investigated with potential E-OPTIMAL participants randomly assigned to watch a     standardized video prior to consent or undergo the standard informed consent process. The     standardized video will review the rationale for women's health research, the importance of     long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has     undergone review by potential subjects, coordinators and physician researchers to ensure that     the relevance and importance of issues potentially impacting on long-term participation in     studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three     additional years. Women will be strongly encouraged to participate in annual examinations and     annual telephone surveys but may participate in only one of these study parts if needed.      We propose to test the following null hypotheses:        1. There will be no difference in time to surgical failure between uterosacral vaginal          vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years          after surgery.        2. The addition of a standardized video detailing the importance of long-term follow-up          studies for POP to the informed consent process will not improve enrollment or retention          in E-OPTIMAL.   "
252891|NCT01166490|"     This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and     tolerability of ASG-5ME and identify the maximum tolerated dose in patients with     pathologically confirmed metastatic pancreatic adenocarcinoma, and to evaluate safety and     tolerability in patients with relapsed or refractory gastric adenocarcinoma.   "
252892|NCT01166503|"     The goal of this study is to determine whether corrective surgery done earlier than the     current standard can better improve the visual and eye movement deficits in children with     infantile esotropia (crossed eyes in infancy).   "
252893|NCT01166516|"     Study to collect post-market safety data for HUD IBV Valve System, a device to control     prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged     air leaks following lobectomy, segmentectomy, or LVRS. An air leak present on post-operative     day 7 is considered prolonged unless present only during forced exhalation or cough. An air     leak present on day 5 should be considered for treatment if it is: 1)continuous, 2) present     during normal inhalation phase of inspiration, or 3) present upon normal expiration and     accompanied by subcutaneous emphysema or respiratory compromise.   "
252883|NCT01166386|"     More than 1.4 million people a year in the United States begin confronting life with the     medical, cognitive, and psychosocial challenges resulting from traumatic brain injury (TBI).     A range of cognitive impairments commonly observed following injury increase caregiver burden     as well as per-person lifetime costs for care and support of survivors of TBI, estimated at     $600,000 to $1,875,000. Our long-term goal is to lessen these burdens through improving the     functional status of patients with TBI by providing an evidence-based, comprehensive, brief,     acute-care intervention, First Steps Acute Neurobehavioral and Cognitive Intervention     (FANCI). The 10-sesson, manualized FANCI Program will be tested in a controlled, randomized     study. Therapeutic components of the FANCI include didactics, cognitive remediation,     demonstration, guided self-reflection, rehearsal, and supported practice of skills and     strategies. Specific hypotheses are that 1) FANCI will result in more improvement in     functional status compared to standard interdisciplinary rehabilitation treatment and 2)     FANCI will result in more improvement on measures of neurobehavioral functioning compared to     standard rehabilitation care for patients with moderate to severe TBI. We base these     hypotheses on the observations that 1) providing information about symptoms, treatment, and     coping results in reduced symptom intensity and duration for patients with TBI, and 2)     inpatient participants in recent FANCI pilot studies learned >80% of the FANCI Program     curriculum, and 3) the most recent pilot study participants had significantly better     functional outcomes at discharge than matched controls. The specific aims of the proposed     study are to 1) evaluate the efficacy of FANCI for improving functional status following     treatment using the FIM, 2) examine the impact of FANCI on broader outcome measures of     general emotional and behavioral functioning and productive activity in the community as     measured post-treatment and at 6-month follow-up, 3) examine contributions of participant     injury severity and cognitive status at time of treatment to treatment outcome and treatment     response, 4) examine contributions of treatment variables of session topic and mastery,     caregiver presence, and concurrent therapies on treatment outcome and treatment response for     inpatients with TBI. Primary outcome measure is the (FIM). We will secondarily compare scores     on the Disability Rating Scale (DRS), Glasgow Outcome Scale-Extended (GOSE), Rehabilitation     Intensity of Therapy Scale (RITS), and Frontal Systems Behavior Scale (FRsBe). Our design is     a parallel groups, single-blind, randomized, controlled trial. We will enroll 150 (75     treatment, 75 control) participants. Inclusion Criteria: Mod to Sev TBI based on time to     commands, English speaker, Length of stay ≥ 5 days in acute BI rehabilitation Unit, 18 years     of age or older, ≥ 79 on GOAT.   "
252884|NCT01166399|"     The study design will be a cohort study to determine the incidence of FI symptoms at 6, 12     and 24 weeks postpartum in primiparous women sustaining an OASI. At 6, 12 and 24 weeks     postpartum, subjects will be contacted by telephone for evaluation of FI symptoms. Symptoms     of FI will be defined by at least monthly symptoms of leakage of liquid, solid stool, and     mucus. Flatal incontinence will be assessed at 24 weeks, based on the Fecal Incontinence     Severity Index, and fecal urgency will be assessed at 24 weeks based on the one question from     the Modified Manchester questionnaire. A sample size of approximately 400-450 subjects will     be enrolled.   "
252885|NCT01166412|"     WHAT IS THE STUDY PRODUCT? The study product is a contraceptive patch, which has the study     drug on the patch. The patch is applied directly to the skin and it contains Levonorgestrel     (LNG) in a time-release form. LNG is a hormone that has been tested and been approved by the     Food & Drug Administration (FDA) in other forms, for example: contraceptive pills,     intrauterine devices (IUDs, which are put in the uterus (womb)) and implants (drug in silicon     tubing placed under the skin). The use of LNG in the form of a contraceptive patch makes this     an experimental drug because the way the drug will be absorbed in the body is a new     technique. This study drug does not contain estrogen and it does not protect against HIV,     AIDS, or any other sexually transmitted diseases (STDs).      LNG is a progestin (a type of drug that is like a hormone. Progestins can cause changes at     the opening of the uterus (womb), such as thickening of the cervical mucus (fluid). This     thickened cervical mucus makes it difficult for the male's sperm to reach and fertilize the     woman's egg. Since LNG is being absorbed through your skin from the patch, it is     experimental, and it is unknown if this study product will really prevent pregnancy like     other progestins.      WHY IS THIS STUDY BEING DONE?      The purpose of this study is to find out:        -  How well the patch prevents pregnancy        -  How safe the patch is to use every day        -  How much study drug needs to be in the patch to make sure that it prevents pregnancy        -  How the study drug in the patch affects cervical mucus (fluids)        -  How the study drug in the patch affects your rate of ovulation (how often you release an          egg)        -  How well the patch sticks to your skin, without falling off, for a week at a time        -  Whether the patch causes any skin irritation or rash (redness or itchiness)        -  Whether the study drug in the patch affects your everyday life and if it causes any side          effects.      WHAT DOES THE STUDY INVOLVE? We expect that there will be approximately twenty (20) women at     each of the six (6) participating clinics in the study. In total, there will be about 120     women from all over the United States who will be in this study. This study is comparing the     effectiveness of two different doses of the study drug (40ug and 75 ug) in the patches. This     study is an open-label randomized trial, meaning that you and your study doctor will be aware     of the dosage of study drug that you will be given. Randomization means that you will be     selected by chance, like tossing a coin or rolling a dice. You have a 50% chance of being in     the group that receives the 40ug dose patch or the group that receives 75ug dose patch.   "
252910|NCT01166750|"     This study is a randomized wait-list controlled trial with repeated measures. There will be     two groups: (1) standard medical care (wait-list control), and (2) standard medical care plus     the adjunctive Jointstrong pain coping skills CD-ROM program (treatment). The study will have     four phases: Pre-intervention Baseline (2 weeks); Intervention (4 weeks); immediate     post-intervention follow up (2 weeks); and 12-week post-intervention follow up (2 weeks). The     purpose of this study is to determine if using a CD-ROM program for juvenile arthritis can     help children learn how to improve their symptoms on their own and reduce the frequency of     symptoms.   "
252886|NCT01166425|"     Study Design This is the second study of a multiphase, multicenter trial that will     comprehensively examine lithium in the treatment of pediatric participants with bipolar I     disorder. In order to examine the treatment of bipolar disorder with lithium, this study will     include four phases of treatment. The first phase, the Efficacy Phase, will include     participants being randomized to either lithium or placebo for 8 weeks to determine the     efficacy of lithium in the treatment of children and adolescents with bipolar I disorder.     Once participants complete the Efficacy Phase, participants may be eligible to continue in     the Long- Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment.     Subsequently, participants meeting response criteria during the Long-Term Effectiveness Phase     will be eligible to continue in the Discontinuation Phase. During the Discontinuation Phase,     participants will be randomized to either placebo or lithium treatment for up to 28 weeks.     Finally, those participants who experience a mood relapse during the Discontinuation Phase     will be enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8     weeks.   "
252887|NCT01166438|"     Urinary incontinence is a prevalent condition that markedly impacts quality of life and     disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of     urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence     (OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB     symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the     use of anticholinergic medications. These treatment modalities may not result in total     continence and often drug therapy is discontinued because of lack of efficacy, side effects     and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle     exercises require consistent, active intervention by the patient which is often not     sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to     determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more     effective than a standardized regimen of oral anticholinergics in reducing urge urinary     incontinence. The null hypothesis is that there is no difference in the change from baseline     in average number of urge urinary incontinence episodes over 6 months between groups.   "
252894|NCT01166529|"     Celiac plexus neurolysis (CPN) has been performed for nearly 100 years to alleviate the     abdominal pain associated with pancreatic malignancy and other conditions, and is usually     undertaken at a late stage in the disease process, when analgesic options have been largely     exhausted or have led to significant and often unacceptable side effects. Until recently, CPN     was most commonly performed under radiographic guidance; however, in the last 10 years, CPN     has been routinely performed under endoscopic ultrasound (EUS) guidance. Several case series     have demonstrated the efficacy and safety of this technique when used to treat the pain     associated with pancreatic malignancy and/or chronic pancreatitis. However, the efficacy of     EUS-guided CPN in the treatment of pain related to non-pancreatic malignancies has yet to be     described. The goal of this study is to assess the efficacy of EUS-guided CPN in the     management of pain in patients with abdominal non-pancreatic malignancies. Our hypothesis is     that EUS-guided CPN will provide adequate pain relief in these patients.   "
252895|NCT01166542|"     The purpose of this Phase 3 study is to evaluate overall survival and progression free     survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in     combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients     with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.   "
252896|NCT01166555|"     This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921     administered as a single subcutaneous dose in healthy volunteers.   "
252897|NCT01166568|"     Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision     in patients who require reading glasses.   "
252898|NCT01166581|"     The primary goal of this study is to determine if preoperative breast MRI findings resulted     in more extensive surgery, i.e., mastectomy than breast conserving surgery, i.e., lumpectomy     in early stage breast cancers at Summa Akron City Hospital. Early stage breast cancer is     defined as breast tumor size less than 5 cm.      The objectives are to:        -  Review early stage breast cancer patient cases treated at Summa Akron City Hospital          between 2006 and 2009 to evaluate clinical and pathological staging        -  Determine the results of preoperative breast MRI and the impact on type of surgery          performed        -  Evaluate the decision to have mastectomy rather than lumpectomy, i.e., physician or          patient decision and if this decision was based on breast MRI findings   "
252899|NCT01166594|"     When a patient with glaucoma who has a pressure that is too high and causing damage to their     vision, despite receiving the maximum amount of medication that can be tolerated, the     decision is made to have glaucoma surgery. Trabeculectomy is the most common form of glaucoma     surgery used to treat open angle glaucoma. During trabeculectomy, an opening is created in     the eye and partially covered with a flap of tissue. This new opening allows fluid to drain     out of the eye bypassing the clogged drainage channels that are malfunctioning in patients     with glaucoma. Studies have found that trabeculectomy significantly reduces vision loss and     lowers eye pressure.      However, many people need another trabeculectomy or other glaucoma surgery because the     surgery may fail either early or much later because the body closes the drain created by the     surgeon. The surgery is also less likely to work in patients with darker pigmentation,     children who have congenital glaucoma, people with difficult to control glaucoma with new     blood vessels growing on the iris, diabetes or persons with prior eye surgery. As a result,     the investigators need to find ways to improve the longterm survival of trabeculectomy     surgery in all patients.   "
252900|NCT01166620|"     To quantify the incremental cost of infections in patients treated with etanercept,     adalimumab or infliximab versus abatacept.   "
252901|NCT01166633|"     Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely     leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive     monitoring is required.   "
252902|NCT01166646|"     The purpose of this study is to determine whether the investigational lotion is an effective     treatment of moderate to severe plaque psoriasis in comparison to an approved cream.   "
252903|NCT01166659|"     The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation     as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary     open angle glaucoma (POAG) who have failed at least one class of topical medical therapy   "
252904|NCT01166672|"     The purpose of this study is to establish feasiblity of recruiting obese breast cancer     survivors at the end of treatment, getting those survivors to lose weight and attend     follow-up visits for 6 months.   "
252905|NCT01166685|"     Background:      Retrospective analyses of long-term BASKET findings identified patients with large     drug-eluting stents (DES) (>2.5mm Stents) as patients at risk for late cardiac death/nonfatal     myocardial infarction. In view of new DES with absorbable polymers and new bare metal stents     BMS) with thin struts and biocompatible polymers, BP-II will be launched to test their     comparative clinical safety up to 12 years if treated with an aspirin/prasugrel combination,     since prasugrel halved stent thrombosis rates compared to clopidogrel in a large ACS trial.      The primary objective is to demonstrate non-inferiority of the Nobori DES stent compared to     the Xience Prime DES stent on safety and e cacy in patients requiring stents >=3.0mm in     diameter on the background of contemporary dual antiplatelet therapy (DAPT) with prasugrel     and aspirin      Set-up:      Multicenter open-label randomized trial.      Patient inclusion:      Unselected series of patients in need of large (>3mm) stents only in native vessels     irrespective of clinical indication.      Patient exclusion:      In-stent restenosis, Left-main disease, cardiogenic shock, planned surgery <12months,     increased bleeding risk, no compliance expected, History of stroke or transient ischemic     attack (TIA).      Randomization:      By centre using sealed envelopes 1:1:1: Nobori:Xience Prime:Prokinetik-stent.   "
252906|NCT01166698|"     The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled     administration of single and multiple increasing doses, and to estimate the maximum dose that     is tolerated in healthy people.   "
252907|NCT01166711|"     The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent     Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium     Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please     (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.   "
252908|NCT01166724|"     The investigators hypothesize that Tacrolimus (Tac) withdrawal from a Tac, MMF and steroid     based triple therapy regimen leads to long term improved/stabilized graft function     (glomerular filtration rate, GFR) primarily as a consequence of halting CNI-induced     fibrogenetic processes that mediate loss of functioning renal tissue. The investigators     further hypothesize that the underlying fibrotic mechanism is mediated by pathophysiologic     processes that promote epithelial to mesenchymal transition (EMT) (mediated by TGF- ƒÒ) and     that early therapeutic intervention may reverse this process (mediated by BMP-7)4.      To address these hypotheses the investigators propose the following clinical and mechanistic     aims:      The investigators will test the hypothesis that switching from Tac to SRL in a Tac based     triple therapy regimen with MMF and steroids in living and or deceased donor renal transplant     recipients leads to improvement in allograft structure and function at 2 years     post-transplantation.      The investigators will test this hypothesis in an open label controlled trial where stable     renal allograft recipients on Tac, MMF, prednisone maintenance immunosuppression will undergo     renal biopsy at 3-4 months post-transplantation and will be randomized to either a) Remain on     Tac, MMF and prednisone (CNI-maintenance) or b) switch the Tac to SRL and continue MMF and     prednisone. The investigators will then compare biopsy derived measures of allograft fibrosis     (CADI, Sirius Red, Banff Chronicity Index) and GFR in the two groups   "
252909|NCT01166737|"     It is still not clear whether a positive AGO-score just selects patients with less aggressive     biologic tumor behavior who as well would have had a positive outcome by chemotherapy only,     or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the     AGO-score was confirmed to select patients with a less than 30% risk of ending with residual     tumor after surgery for recurrent disease. This could avoid including patients into the     present surgical protocol who could not benefit from an operationThe goal of this third     DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether     maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy     can improve overall survival as compared to platinum based combination chemotherapy alone in     AGO-score positive patients.   "
252911|NCT01166763|"     The overall goal of this project is to determine if high dose vitamin D3 given to     premenopausal women at high risk for development of breast cancer, who initially have     insufficient levels of 25-hydroxy vitamin D (<30 ng/ml), will raise 25(OH)D levels above 50     ng/ml. If so, will certain risk biomarkers for development of breast cancer be reliably and     favorably modulated?   "
252913|NCT01166789|"     The purpose of this research study is to determine how Lubiprostone, a medication used to     treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to     reduce clinical pain. Lubiprostone acts in the small intestine to cause an increase in the     secretion of chloride, water and sodium. The increased fluid causes food residue to move     through the bowel more quickly and makes the stools softer. First, we want to test the idea     that Lubiprostone works by making a person less sensitive to pain. Second, we want to confirm     that Lubiprostone decreases the time it takes fecal matter to travel through your GI tract,     referred to as transit time.   "
252914|NCT01166802|"     The aim of this study is to develop and validate a questionnaire (non-invasive technique) to     identify patients who are hypervigilant for noxious visceral sensations and who show a lower     threshold to report pain. This questionnaire would be useful in studies investigating the     role of visceral pain hypervigilance and pain sensitivity in the comorbidity of IBS with     other somatic disorders.   "
252915|NCT01166815|"     Zinc deficiency is prevalent in children in developing countries. Zinc-supplementation is     proven to reduce the duration and severity of childhood diarrhea in randomized controlled     trials. However, despite this evidence, its efficacy to reduce diarrhea morbidity in adults     remains unknown. The main objective of this study is to determine the efficacy of     Zn-supplementation on diarrhea incidences in a vulnerable adult population. The study will be     carried out in Kombewa division, Kisumu District and will involve 500 adults aged 18-55     years. They will be randomly assigned to receive Zn supplement (or placebo) on a daily basis     over a 3 month period. Morbidity information will be collected daily for 4 months, while     anthropometric measures and laboratory data will be obtained at study onset, end of     supplementation and study conclusion. In addition, HIV and malaria tests will be carried out     during the study as they are important confounders. The significant differences in diarrhea     incidence between the Zn-group and the placebo-group will be determined using SPSS. The     results are expected to provide the scientific basis and common pathway for development of an     anti-diarrheal supplement for vulnerable populations such as environmental refugees, deprived     and displaced persons, and troops prior to deployment.   "
252916|NCT01166828|"     NRI research focuses on nursing interventions that are patient-centered, culturally     congruent, cost-effective and outcome-driven. High priority populations of interest are     veterans with Spinal Cord Injuries (SCI). The development of innovative tele home techniques     for preventing pressure ulcers in veterans with SCI is of high importance in the VA. Our     findings may provide clinicians with improved methods for skin and wound assessment and more     effective and efficient PUP strategies for Hispanic and non Hispanic veterans. The new model     for primary care, the patient-centered Medical Home provides an exciting change in the VA     that can benefit from the proposed project.   "
252927|NCT01166971|"     The purpose of this study is to prospectively evaluate postoperative visual and refractive     parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3     versus those bilaterally implanted with the Tecnis Multifocal 1-piece.   "
252928|NCT01166984|"     The primary objective of this study is to establish the safety profile and maximum tolerated     dose of AB103 given as a single intravenous infusion or by repeated (5 days) IV infusions in     healthy volunteers.   "
252929|NCT01166997|"     The ULTIMA study is intended to prove that in patients with pulmonary embolism and a right     ventricular end diastolic diameter to left ventricular end diastolic diameter ratio ≥1 (RV/LV     ratio) will benefit from treatment with ultrasound accelerated thrombolysis (rt-PA) as     compared to unfractionated heparin anticoagulation. Specifically, at 24 hours the RV/LV ratio     will be significantly reduced in the treatment arm compared to the control arm.   "
253031|NCT01168206|"     The association of nutritional supplement TK3 to conventional treatment of cancer patients     reduces the intensity and frequency of toxic effects and side effects caused by adjuvant or     palliative treatments for the protection of healthy tissues, resulting in a better quality of     life.   "
252917|NCT01166841|"     The use of minimally invasive cardiac surgery has progressed over the last 5-10 years to     allow access to the heart through a small incision in the right chest. This avoids the use of     a sternotomy incision through the bone in the front of the chest. The benefits of such an     approach are cosmetic (smaller incision not easily visible) and faster recovery. The     minimally invasive approach also eliminates the risk of sternal wound infection. Minimally     invasive cardiac surgery however poses additional challenges; one of the biggest is access to     the large blood vessels which need to be cannulated to allow the heart lung machine to     function. In conventional surgery, these vessels are easily accessed as they are entering or     leaving the heart. In minimally invasive surgery, the cannula are placed into easily     accessible arteries and veins, traditionally the femoral vessels. These vessels are smaller     than those by the heart and so require smaller cannula, which provide challenges to the heart     lung machine. One way around this is to use more cannulae and so cannulation of a vein in the     neck is also performed. This cannula however, has been associated with neck hematoma, tearing     of the vein and blood loss. While placement of the cannula in the neck is routine at LHSC     now, when this surgery was first performed here 10 years ago, it was done so without the neck     cannula and with no injury to patients. The purpose of this study therefore, is to more     rigorously study the effect of the neck cannula on heart lung bypass, and more specifically     to see if oxygen delivery to the organs, and the brain in particular is sufficient to avoid     hypoxia.   "
252918|NCT01166854|"     The researcher wants to explore the genetic causes of muscle disease. The researcher is     particularly interested in muscle disorders that occur in combination with diseases of bone     that appear to be passed on from generation to generation.      Diffuse Optical Spectroscopy will measure the concentrations of blood, water, and lipids     (fats, for example) in your tissues. This device essentially measures the color of tissues in     order to determine tissue physiology (its physical and chemical processes).   "
252919|NCT01166867|"     The researcher want to use video signals to monitor heart rate, respiration rate and oxygen     saturation using Photo-plethysmography (PPG) as the underlying mechanism for the method:     periodic changes in skin reflectance, induced by the cardio-vascular wave, are measured using     light.   "
252920|NCT01166880|"     The researcher want to know whether reflections of light can be used to provide real-time     pictures of blood vessel formation around infants' heads. This approach is called laser     speckle imaging   "
252921|NCT01166893|"     According to the National Burn Repository 2007, the most common type of burn injury is a     partial thickness burns. The current standard of care for partial thickness burns is two     weeks of topical therapy and wound care. Burns that do not heal within two weeks undergo     surgical excision and skin grafting.   "
252922|NCT01166906|"     There is a gating mechanism in the dorsal horn of the spinal cord that acts to facilitate or     inhibit transmission of pain signals to the brain. The gate can be closed by mechanical     stimuli such as touch and vibration.   "
252923|NCT01166919|"     Port wine stain, also called nevus flammeus, is a congenital, cutaneous vascular malformation     involving post-capillary venules which produces a light pink to red to dark-red-violet     discoloration of the skin. It is estimated that Port wine stain occurs in 3 children per     1,000 live births. Approximately 900,000 individuals in the United States and twenty million     people worldwide have Port wine stain birthmarks .   "
252953|NCT01160913|"     The purpose of this randomized double-blind study is to evaluate in which anatomical layer     (AF versus BF) continuous wound infusion of local anesthetics combined with NSAIDs through a     multiorifice catheter has the best effectiveness during the first 48 hours on postoperative     pain intensity after elective cesarean delivery.   "
252924|NCT01166932|"     Objective: To compare the clinical effectiveness and hospital costs, the initial empirical     treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community     Acquired Pneumonia (CAP) severe.      Methods: Clinical prospective randomized study in children aged two months to five years of     age with a diagnosis of severe CAP, according to criteria of World Health Organization (WHO),     admitted to the Pediatrics Ward of the Hospital of the Medical School of Botucatu- UNESP. We     excluded children with comorbid disorders (primary and secondary immunodeficiency) with acute     or chronic kidney disease, referred patients receiving antibiotics proposal and history of     allergy to antibiotics proposed. We included 104 children who were randomized into two groups     to receive: Oxacillin / Ceftriaxone IV (GCO, n = 48) and Amoxicillin / Clavulanate IV (GAA, n     = 56). Patients of the GAA, after clinical improvement, has been receiving the same oral     antibiotic, and maintaining clinical stability, were discharged from hospital, the GOC     received any IV treatment. The outcomes analyzed were time to clinical improvement (fever and     tachypnea), duration of oxygen therapy, hospitalization time, need to expand the     antimicrobial spectrum progression to pleural effusion / empyema (DP / E) and hospital costs.     Treatment failure was determined by the need to expand the antimicrobial spectrum after 48     hours of hospitalization.   "
252925|NCT01166945|"     The investigators objective is to compare short course (5 days) to long course (14     days)antibiotics for the treatment of acute bacterial sinusitis in children. The     investigators hypothesize that short course therapy will lead to more frequent relapses of     sinusitis and will not reduce resistant organisms.   "
252926|NCT01166958|"     Current osteoporosis therapies produce a prompt increase in bone mass, followed by only     modest or no further subsequent gains. This limitation, known as the remodeling transient,     reflects the coupling of bone resorption with formation such that interventions impacting     either of these processes lead to compensatory changes of the other. For example, medications     which increase bone formation promptly also stimulate bone resorption. Thus, given the need     to dramatically increase bone mass in patients with osteoporosis, it is necessary to     uncouple formation and resorption. The investigators believe this to be possible using     currently existing FDA-approved therapeutic agents, by using a novel, sequential approach.      This pilot project will obtain preliminary data essential to support future work. In this     study, the investigators will begin to explore the use of sequential anabolic treatment with     teriparatide followed by antiresorptive therapy with raloxifene. The investigators propose     that such sequential treatment will allow opening of the anabolic window, the brief period     of time following initiation of teriparatide therapy in which bone formation exceeds     resorption.   "
252930|NCT01167010|"     The primary objective will be to compare the Eurofarma and Alenia formulations regarding     their impact on the pulmonary function of mild to moderate persistent asthma patients and the     secondary objective will be to compare the three study formulations regarding the clinical     control of the symptoms and the patients' compliance to the treatment.   "
252931|NCT01167023|"     The purpose of this trial is to assess the safety of Prasugrel in adult patients with sickle     cell disease (SCD) by monitoring the rate and severity of hemorrhagic events requiring     medical intervention compared to placebo for 30 days.   "
252932|NCT01167036|"     The purpose of this study was to determine if using a specialized massage tool was more     effective than a placebo treatment in relieving pain in the upper trapezius muscle along the     top of the shoulder.   "
252933|NCT01167049|"     To investigate the efficacy of capecitabine combined with paclitaxel as neoadjuvant     chemotherapy for gastric cancer with liver metastasis only   "
252934|NCT01167062|"     This is a randomized double blind placebo-controlled study that will assess the efficacy of     Tamsulosin oral-controlled absorption system (OCAS) 0.4 mg in the conjunctive medical     treatment of distal ureteral stones with a size of 4-10 mm compared to placebo in control     group.   "
252935|NCT01160679|"     This prospective, multi-center, 12 weeks naturalistic NIS trial will be conducted in 25     hospitals in naturalistic treatment setting. There will be no experimental component     associated with this study and all observational activities have to be part of routine care     visit: baseline (week 0), week 4 and week 12.   "
252936|NCT01160692|"     A Study to evaluate the cognitive effects and tolerance of a Multi-Vitamin/Mineral     Preperation containing Gingko in elderly subjects with age associated memory impairment.   "
252937|NCT01160705|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients will respond to treatment.      PURPOSE: This clinical trial is studying blood samples in predicting how patients with     prostate cancer will respond to treatment with docetaxel.   "
252938|NCT01160718|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells.     AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. It is not yet known whether fulvestrant is more effective with or without AZD6244 in     treating patients with advanced breast cancer.      PURPOSE: This randomized phase II trial is studying how well fulvestrant works with or     without AZD6244 in treating patients with advanced breast cancer that progressed after     aromatase inhibitor therapy.   "
252954|NCT01160926|"     To determine the maximum tolerated dose (MTD) of AZD6244 or AZD2171 when combined with     pre-operative capecitabine and radiotherapy in patients with locally advanced rectal cancer.   "
252939|NCT01160731|"     RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,     such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving panobinostat together     with etoposide and cisplatin may kill more tumor cells.      PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when     given together with etoposide and cisplatin as first-line therapy in treating patients with     extensive-stage small cell lung cancer.   "
252940|NCT01160744|"     The purpose of this study is to determine if participants with Stage IV NSCLC have a better     outcome when treated with IMC-1121B in combination with pemetrexed + carboplatin/cisplatin or     gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin     or gemcitabine + carboplatin/cisplatin alone.   "
252941|NCT01160757|"     The purpose of this study is to find out how effective and safe an experimental ultrasound     device is for treating Acute Acne lesions.   "
252942|NCT01160770|"     The objective of this study is to evaluate the long-term safety and effectiveness of     open-label clobazam in the treatment of drop seizures in subjects with LGS.   "
252943|NCT01160783|"     This study is working towards gaining a better understanding of the genetic and environmental     factors involved in autism spectrum disorders (ASD), which includes autism, pervasive     developmental disorder (PDD), and Asperger's syndrome. The investigators hope that     information gained from this study will lead to new ways of diagnosing and treating ASDs.   "
252944|NCT01160796|"     This is a national, multi-centre, randomized, double-blind placebo-controlled, phase III     superiority trial.      The main objective of the trial is to assess the efficacy of Lcr35® by comparing the mean     time before the onset of the first clinical recurrence confirmed by laboratory tests in     patients with bacterial vaginosis treated with Lcr35® versus placebo.      Patients with bacterial vaginosis will be enroll by private gynecologists. Each patient will     receive a treatment for the initial episode(Metronidazole)and a treatment to prevent the     recurrence of bacterial vaginosis (Lcr35®).   "
252945|NCT01160809|"     The combined use of a mosquito repellent and long lasting insecticidal nets (LLINs) by     household members would result in a 40% reduction in malaria prevalence compared with     households that only use LLINs.   "
252946|NCT01160822|"     The purpose of this study was to determine whether, in patients with mild to moderate knee     osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.   "
252947|NCT01160835|"     Quadriceps-sparing minimally invasive total knee arthroplasty (TKA) with side-cutting     instruments has been proposed to limit surgical dissection without compromising the surgical     outcome. We conducted a prospective, randomized study to compare the outcomes of     quadriceps-sparing TKA with conventional medial parapatellar TKA, with two-year follow-up.      We hypothesize that the quadriceps-sparing arthrotomy would not outperform the conventional     medial parapatellar arthrotomy in TKA, in terms of postoperative recovery of quadriceps     muscle strength, alignment of the prosthetic knee, and clinical outcome.   "
252982|NCT01167127|"     The main objective of the study is to observe the OXN treatment of patients with moderate to     severe non-malignant pain in daily clinical practise with respect to pain relief and bowel     function. Patients who have insufficient pain relief and/or unacceptable side effects with     the previous analgesic treatment WHO step 1 or 2 and require around-the-clock opioid therapy     can be included in the study.   "
252948|NCT01160848|"     Open, prospective, randomized, single-centre study in patients with moderate to severe facial     acne vulgaris. Three circular areas with a diameter of 4 cm, each circle including at least 4     inflammatory lesions, will be selected in acne-affected areas in the face. One area should be     identified on each cheek and one area should be identified on the forehead. The minimum     distance between the three areas should be at least 4 cm. For each patient the three areas     will be randomized to either a pre-treatment cleaning using a wipe containing an ethyl     alcohol solution(one area) or a cleansing wipe containing saline water (two areas), before     application of the Visonac cream. One of the areas cleaned with saline wipe will also be     occluded with a transparent dressing (Tegaderm) during the incubation time. In vivo     fluorescence spectroscopy will be performed in the three areas before cream application, and     at 1h, 1.5h, 2h, 2.5h and 3 h after cream application. After the last fluorescence     spectroscopy reading, the cream should be wiped off and the patient should protect the three     areas from sunlight, prolonged, or intense light for 2 days.      The study was extended with additionally 8 patients to explore the photoactive porphyrin     levels over a 24 hour period:      The patients will clean their face with Cetaphil Gentle Skin Cleanser before cream     application. For each patient the three areas will be randomized to Visonac 80mg left on the     skin for 24 hours and Visonac (MAL8%) to be wiped of after 1 hour.      In vivo fluorescence spectroscopy will be performed at all three areas before cream     application, and at 2h, 3 h, 4h, 5h, 8h, 10h, 11h, 12h, 13h, 15 and 24h after cream     application. The exact time points may be adjusted based on the result from the previously     included patients. All patients will be instructed to protect the three areas from sunlight,     prolonged, or intense light for 2 days.   "
252949|NCT01160861|"     This is a Phase Ib, randomized, blinded, placebo-controlled, multiple-ascending dose study in     patients with seasonal or perennial allergic rhinitis to investigate the safety,     tolerability, and pharmacokinetics (PK) of MEMP1972A.   "
252950|NCT01160874|"     The Attention Deficit/ Hyperactivity Disorder (ADHD) is a developmental disorder which     affects 3 to 5 % of school age children. This disorder persists in the adulthood for 60 % of     subjects. Children with ADHD are sleepier during the day than normal children. However, there     is no information concerning the diurnal sleepiness of adults with ADHD and the impact of     this sleepiness on their driving capacity. The investigators postulate that the negative     impact of ADHD is due to an awakening disorder which adds to the attentional disorder. The     aim of this study is to estimate both the sleepiness by a Maintenance Wakefulness Test (MWT)     and the capacity to drive in adults with ADHD.   "
252951|NCT01160887|"     The purpose of this study is to investigate whether patients with diabetes-related peripheral     neuropathic pain also have non-recognized damage to the intestine caused by autonomic     neuropathy. The model will shed light on aspects of peripheral nerve injuries on both somatic     and as well as visceral sensory nerves. Classical autonomic parameters from     electrocardiography (ECG) and Holter (24-h ECG and blood pressure) are compared with     peripheral nerve injuries. The damage of autonomic nerves often recognized late in the course     when patients develop gastroparesis, however an earlier recognition of this nerve damage may     help clarifying the fundamental pathomechanisms and thereby optimize treatment for this     patient group in the future.   "
252952|NCT01160900|"     Few reports described outcomes of complete compared with infarct related artery (IRA) only     revascularization in patients with ST elevation myocardial infarction (STEMI) and multivessel     coronary disease (CAD).      The purpose of this study is to determine outcome (death, myocardial infarction, target     vessel failure) of 180 consecutive patients with STEMI and multivessel CAD undergoing primary     angioplasty.      Before the first angioplasty patients are randomized to 2 different strategies: 1) culprit     vessel angioplasty only, 2) staged revascularization.   "
253201|NCT01164137|"     This initiative aims to decrease the risk of medication errors at the hospital-community     interface as well as health system utilization following hospital discharge by implementing a     pharmacist-led medication reconciliation in the patients' home within 72 hours of hospital     discharge.   "
252955|NCT01160939|"     Objectives: To study the behavior and cardiovascular safety protocol to the front     low-intensity exercise in patients with heart failure (HF) severe, awaiting heart     transplantation. Methods: The investigators studied 21 patients with severe HF on the list     for a heart transplant at the University Hospital of UNIFESP. After evaluation, patients     underwent exercise protocol with six stages of exercise (1. upper limbs, 2. inferiors, 3.     walk 35 m, 4. ½ flight of stairs, 5. walk 200 m 6. a flight of stairs) with intensity between     2-6 metabolic equivalents. These also were followed for an average period of 17 months as the     clinical complications and death. Results: From the patients studied, three were not able to     perform the full protocol, and the variables body mass index, maximal inspiratory and     expiratory pressure measurement (Pimáx and Pemáx, cmH2O) and number of previous admissions,     showed the most divergent behavior of the sample studied. A greater increase in heart rate,     double product and scale of perceived exertion during step 5 was observed during the     protocol. Blood pressure levels showed little change between stages, and there was no     arrhythmias incidence increase (kappa = 0.552) compared to effort. A positive correlation     scale was perceived in exertion walking distance of 200m, with systolic blood pressure (r =     0.4, p = 0.02). Overall observed lower values of maximal inspiratory pressure and increased     blood pressure and elevated heart rate in patients with death outcome. Conclusion:     Cardiovascular behavior against exercise protocol was well tolerated and safe, but suggests     need for monitoring. Information collected at initial clinical evaluation associated with     decompensation and death, and may help stratify these patients.   "
252956|NCT01160952|"     -  The primary objective of this study is to evaluate the efficacy and safety profile of          itraconazole as in primary prophylaxis        -  The second objective of this study is to find the difference between long-term versus          short-term sequential therapy of Itraconazole (intravenous followed by oral          itraconazole) as primary prophylaxis of invasive fungal infections (IFI) in patients          undergoing allogeneic stem cell transplantation (allo-SCT)        -  also to explore the relationship between the incidence of IFI with plasma concentrations          of itraconazole and hydroxy-itraconazole   "
252957|NCT01160965|"     The aim of this trial is to compare the local anaesthetic ropivacaine to local anaesthetic     levobupivacaine in converting the standard patient controlled labour epidural to provide     anaesthesia for an emergency Caesarean section. This is a technique commonly known as an     epidural top-up. The investigators set out to disprove the hypothesis that there is no     difference between the 2 local anaesthetics in the time of onset and number of times epidural     top-up needs supplementing during surgery.   "
252958|NCT01160978|"     The aim of the study is to investigate the effects of simvastatin treatment on     ischemia-reperfusion injury in the context of cardiac-, lung-, kidney-, and liver     transplantation.   "
252983|NCT01167140|"     This is a prospective, non-randomized study to evaluate the performance of the MyoScience     Cryo-Touch II device for the treatment of wrinkles.   "
252984|NCT01167153|"     The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine     (EXforge®) with nifedipine, as well as vascular function index.   "
252959|NCT01160991|"     Patients suffering from schizophrenia have a high risk to become obese and develop diabetes.     Risk of obesity is particularly high with some newer schizophrenia drugs, such as clozapine     or olanzapine. These drugs are called atypical drugs and exert their action in part by     occupying receptors for serotonin, particularly the 5HT2A receptor subtype. This receptor may     also interfere with glucose metabolism and insulin action. The purpose of this study is to     compare an atypical antipsychotic drugs, olanzapine, which acts by occupying the 5HT2A     receptor, to another antipsychotic drug, amisulpride, which mainly acts through the dopamine     pathway. Healthy volunteers are recruited and asked to take a single dose of each drug and of     placebo on separate days. Then, a combined glucose clamp study will be performed in order to     test the effects of these drugs on insulin sensitivity and insulin secretion.   "
252960|NCT01161004|"     It has been demonstrated that antagonism of neuromuscular blockade (neostigmine 0.04 mg kg-1)     affects depth of anaesthesia with an increase in bispectral index (mean maximal change of     7.1) and middle-latency auditory evoked potentials (mean maximal change of 9.7).      Sugammadex has a quicker and more complete effect than neostigmine. This study aims to     demonstrate if sugammadex administration increases bispectral and neurosense indices of the     depth of anesthesia while patients still receive propofol-remifentanil iv anesthesia.   "
252961|NCT01161017|"     Mechanism-based choice of therapy for pain:      Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?   "
252962|NCT01161030|"     This trial examined the impact of acute and chronic almond ingestion on indicators of glucose     control (postprandial glycemia and hemoglobin A1c). Hypotheses:        1. Almonds will stimulate the secretion of GLP-1 in healthy adults and in adults with T2D          The investigators were not able to demonstrate a relationship between GLP-1 secretion          and almond consumption. Individuals with T2D were characterized with significantly          greater GLP-1 secretion than the non-diabetic control subjects.        2. Acute ingestion of almonds will decrease the postprandial glycemia and insulinemic          responses in healthy controls and in individuals with T2D The investigators data support          the hypothesis: almond consumption by individuals with T2D did attenuate postprandial          glycemia; however, almond consumption did not alter glycemia in non-diabetic control          subjects        3. Chronic almond ingestion for 12 weeks will reduce fasting glucose (FG) and A1c          concentrations in individuals with T2D The investigators data demonstrated modest          beneficial effect of almond consumption on A1c in individuals with T2D. Almond          consumption was also associated with modest weight loss as compared to the control          treatment (low fat cheese sticks).   "
252963|NCT01161043|"     The purpose of this study is to assess performance of a new subcutaneous glucose sensor over     a seven day sensor life when used with currently marketed Medtronic Diabetes devices. In     addition performance of the new sensor will be calculated for use of the new sensor with     proposed new devices using new calibration algorithms.   "
252964|NCT01161056|"     The purpose of this study is to enrol generally healthy adults, who are asked to provide a     blood sample, to study how the immune system works.   "
252965|NCT01161069|"     The purpose this study is to evaluate the safety and toleration of PF-03049423 following     multiple dose administration as an oral solution to healthy young adult volunteers and     healthy elderly volunteers. The study will also evaluate the pharmacokinetics of PF-03049423     after multiple dose administration to healthy young adult volunteers and healthy elderly     volunteers. The study will also explore the relationship between blood pressure (supine and     standing) and PF-03049423 concentration.   "
253441|NCT01173120|"     The purpose of this study is to determine the safety and acceptability of a device used in     place of traditional syringes for abatacept self-injection.   "
252966|NCT01161082|"     This study will test the safety, tolerability, and bioeffects (how the body reacts to the     drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in     hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will     be administered by subcutaneous injection at the clinic. There will be a total of 2 or 3     study drug injections over 16 clinic visits, which will include 3 overnight stays(study     duration 148 days, not including the screening period). Patients on atorvastatin will take     their daily dose in the morning for the duration of the study. Patients will be monitored by     the study staff for side effects and the body's response to the study drug. Vital signs(blood     pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples     will be collected at some or all visits.   "
252967|NCT01161095|"     The primary objective of the investigators study is to determine if there is a difference in     continuation rates at six months in women who are randomized to have the Levonorgestrel     Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as     after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks     postpartum).   "
252968|NCT01161108|"     The purpose of the study is to evaluate the safety and efficacy of oral melatonin in     improving sleep continuity in children with epilepsy and neurodevelopmental delay who have     chronic insomnia by comparing Fast Release Melatonin (FR MLT) to placebo and Timed Release     Melatonin (TR MLT) with placebo in a randomized cross-over design trial.   "
252969|NCT01161121|"     The purpose of this study is to determine if regadenoson is as safe and effective as     adenosine when used in the cardiac catheterization lab during measurement of coronary flow     reserve and fractional flow reserve. The study hypothesis is the assessment of Fractional     Flow Reserve (FFR) in the catheterization lab can be performed with equivalent accuracy when     hyperemia is induced with IV Regadenoson compared with IV Adenosine without compromising     patient safety.   "
252970|NCT01161134|"     The objective of this study is to determine the relative bioavailability of one 15 mg     Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam)     Tablet (Boehringer Ingelheim Pharmaceuticals Inc., USA) under fasting conditions.   "
252971|NCT01161147|"     The objective of this study is to determine the relative bioavailability of one 15 mg     Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam)     Tablet (Boehringer Ingelheim Pharmaceuticals Inc., USA) under fed conditions.   "
252972|NCT01161160|"     This study is designed to characterize the safety and immunogenicity of pandemic influenza     (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.   "
252973|NCT01161173|"     This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in     routine clinical practice as second-line treatment in patients with recurrent or metastatic     non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1     course of standard systemic chemotherapy, experienced disease progression, and who are     receiveingTarceva in a second-line setting. Patients will also be followed through third-line     treatment if there is disease progression on Tarceva therapy.   "
252974|NCT01161186|"     The purpose of this study is to evaluate optimal dose and safety of the combination of     Abraxane, gemcitabine, and Xeloda (capecitabine) (AGX) as first-line therapy in patients with     metastatic pancreatic cancer.   "
252975|NCT01161199|"     Despite the dramatic improvements that have resulted from combination antiretroviral     treatment, long-term efficacy, toxicity, cost, and the requirements for life-long adherence     remain as formidable challenges. Also, there is emerging consensus that persistent     HIV-associated disease occurs during long-term highly active antiretroviral therapy (HAART).     This disease may be due to either direct drug-toxicity and/or persistent viral     replication/production and/or persistent HIV-associated inflammation. Hence, strategies aimed     at achieving complete viral eradication may be needed in order to fully restore health among     HIV infected individuals. Even if complete eradication proves impossible—as most believe to     be the case—a less rigorous but still desirable outcome might be achieving durable control of     virus in the absence of therapy. That a functional cure is possible is well illustrated by     those rare individuals who are able to durably control replication competent virus in the     absence of therapy (elite controllers).      A more complete understanding of the relationship between inflammation and viral persistence     is necessary before more rationale studies of HIV eradication can be designed. Also, a well     validated high through-put virologic assay needs to be developed that can estimate the size     of the latent reservoir. Since the level of replication competent virus in long-term treated     patients (and in elite controllers) is very small (< 1% of CD4 cells harbor HIV), large     numbers of CD4+ T cells most be obtained from study participants in order to routinely     isolate and quantify virus persistence.   "
252976|NCT01161212|"     In French primary schools, children participate in 3 compulsory hours of physical education     (PE) each week unless they have a medical contra-indication. But, there is no scientific     evidence (randomized trial) that a weekly physical activity splitting up of these 3 hours of     PE brings or not the same effects, particularly to prevent overweight or obesity.      Regul'aps is a cluster randomized controlled trial which wants to evaluate whether splitting     up the 3 hours into 3 or 4 sessions (vs. 1-2 sessions) of PE per week has an effect on speed     of a BMI increase and on health-related quality of life (HRQoL) over the school year.      Study hypothesis: reduction of speed of increase of BMI and an increase of HRQoL   "
252992|NCT01167257|"     Overactive bladder (OAB) is a bothered symptom syndrome. Traditional medication for OAB is     antimuscarinic agent. However, adverse events such as dry mouth, constipation, blurred     vision, and dizziness may prohibit patient to take this drug for OAB. Intravesical botulinum     toxin A (BoNT-A) is a novel treatment however, BoNT-A can cause acute urinary retention and     large postvoid residual. In this grant we will evaluate liquid liposome delivery of BoNT-A     (Liposome encapsulated BoNT-A) into the bladder without the need for cystoscopic-guided     needle injection for refractory OAB.   "
252993|NCT01167270|"     This study will test an intervention program designed to provide developmentally appropriate     guidance to parents of infants on responsive parenting and healthy lifestyle to see if that     intervention will prevent rapid weight gain in infancy and overweight at age 3 years.     Further, compared with control infants, intervention infants will have lower body mass index     (BMI) percentiles at age 3. The investigators also hypothesize that control infants will gain     weight more rapidly over time.   "
252977|NCT01161225|"     Aims of this study are:        1. To determine the feasibility of implementing the intervention using a peer-assisted          asthma day camp for adolescents with asthma.        2. To determine patterns of change in knowledge, attitudes toward asthma, self-efficacy,          perception of barriers, and self-management behaviors, asthma control and quality of          life over time among peer leaders.        3. To test the following hypothesis:             -  Adolescents participating in a peer-assisted asthma camp program will report               improved knowledge, attitudes toward asthma, self-efficacy, and self-management               behaviors, decreased perception of barriers, and increased asthma control and               quality of life at 3-, 6- and 9-months post-intervention compared with the               adult-led camp group.        4. To examine the moderating effect of personal factors (e.g., age, sex, socioeconomic          status, race, illness status, family support) on intervention outcomes such as          self-management behaviors, asthma control and quality of life in adolescents with          asthma.        5. To examine the effect of the peer-assisted camp program on self-reported health care          utilization including emergency department visits, days of hospitalization, outpatient          visits by comparing between baseline and 9-months post-camp data and between the          peer-led camp and the adult-camp programs.   "
252978|NCT01167075|"     The aim of the study is to assess the efficacy and tolerability of the low-volume supplement.     The investigators randomized critically ill patients to receive Intestamin plus Fresubin or     Fresubin alone.   "
252979|NCT01167088|"     The purpose of this study is to investigate whether a new medicine, called mitoquinone, will     reduce raised liver enzymes due to NAFLD and to see if it is safe.   "
252980|NCT01167101|"     Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet     conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good     effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized     controlled study to assess the effect of a combination therapy of rebamipide and proton pump     inhibitor (PPI) on post ESD ulcer healing.   "
252981|NCT01167114|"     In this research study, the investigators are looking to see how effective STA-9090 is in     treating esophagogastric cancer. The investigators will also evaluate the side effects of     STA-9090, and examine the relationship between the presence of HSP-90 and how well study     participants respond to STA-9090. STA-9090 works by blocking a protein in tumor cells called     HSP90, which is thought to play a role in tumor growth. By interfering with this protein's     function, STA-9090 may help kill tumor cells. This drug has been used in other research     studies and information from those other research studies suggests that this agent may help     to slow tumor growth in esophagogastric cancer.   "
252985|NCT01167166|"     For patients with leukemia who have not responded to or have progressed after an initial     response to standard therapy, therapeutic options are limited. Although responses to standard     regimens do occur, durable remissions are achieved infrequently and current regimens are not     curative in the majority of patients. Identification of active agents in patients with     relapsed Acute Myeloid Leukemia (AML) ultimately affords the potential for use upfront as a     component of induction regimens that may translate to improved outcome. Therefore,     development of new agents is of critical importance. This study will look at a new,     investigational agent, ON 01910.Na, to determine if it has the potential to help Patients     with AML and Acute Lymphocytic Leukemia (ALL) and transformed Myeloproliferative Neoplasms.   "
252986|NCT01167179|"     The purpose of this study is to conduct an early evaluation of a nurse-led follow up     intervention added to the usual medically oriented follow up care. Besides evaluating the     feasibility and acceptability to patients, the effect on psychosocial adjustment and quality     of life of patients is determined.   "
252987|NCT01167192|"     The purpose of this study is to determine whether platinum-based chemotherapy (either     cisplatin or carboplatin), when given with radiation therapy prior to surgery, is effective     in improving response to treatment in triple negative breast cancer patients. This treatment     is being studied in this type of breast cancer because it does not respond well to commonly     used treatments such as tamoxifen or herceptin.   "
252988|NCT01167205|"     The purpose of this study is to determine whether astaxanthin (ASX) supplementation will     reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese     adults.   "
252989|NCT01167218|"     The purpose of this study is to conduct a Verify now assay to detect platelet aggregation     defects in patients with Myelodysplastic syndrome(MDS), immune thrombocytopenia purpura (ITP)     and myeloproliferative disorders (MPD).   "
252990|NCT01167231|"     The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been     associated with a significant reduction of cardiovascular events. Additionally, acarbose has     been shown to have a beneficial influence on some of the other cardiovascular risk factors     (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose     may be a promising therapeutic strategy for reducing the increased risk for cardiovascular     disease. Further studies are needed to confirm the influence of acarbose on cardiovascular     risk factors in the real life setting.   "
252991|NCT01167244|"     The purpose of this study is to observe an improvement in overall response rate in NSCLC     subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR     mutation positive or who have had a prior a response.   "
252994|NCT01167283|"     This study was designed to test the following hypothesis:      To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type     distribution.   "
252995|NCT01167296|"     To use Cook balloon uterine stent to prevent intrauterine adhesion (IUA), and to see if     leaving it in the uterus will cause uterine infection.   "
252997|NCT01167322|"     The aim of the present Phase III study is to assess the positive predictive value of NPC-07     (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and     pharmacokinetics following a single dose of NPC-07 orally, at a dose of 20mg/kg/body weight,     3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent     malignant glioma (WHO grades III/IV).      Positive predictive value will be confirmed by percentage of patients showing positive tumor     cell identification in all biopsies taken from areas of strong and weak fluorescence. This     study will be divided into two stages. After reviewing of the result of safety and     pharmacokinetics of NPC-07 in small number of subjects by independent safety monitoring     committee, more subjects will receive NPC-07 in Step II.   "
252998|NCT01167335|"     This study will assess the efficacy of BGG492 as adjunctive treatment in patients with     refractory partial onset seizures   "
252999|NCT01167348|"     The purpose of this study is to examine whether auricular acupressure is effective in     reducing body weight, waist circumference, or lipid profile.   "
253000|NCT01167361|"     This study aims to prospectively estimate the incidence of Respiratory virus (RV) infections     in children with symptoms of an upper respiratory tract infection (URTI) or lower respiratory     tract infection (LRTI) at St. Jude Children's Research Hospital (SJCRH) using the FilmArrayTM     System, a novel highly sensitive and rapid assay for RV detection. An aliquot from the     leftover sample remaining after clinical diagnostic testing will be used for FilmArrayTM     analysis. Patients will be accrued on the study over a one year period.   "
253001|NCT01167374|"     Treatment options for patients with advanced hepatocellular carcinoma (HCC) are often     limited. In most cases, they are not amenable to local therapies including surgery or     radiofrequency ablation. The multi-kinase inhibitor sorafenib has shown to increase overall     survival in this patient group for about 3 months.      Radiation therapy is a treatment alternative, however, high local doses are required for     long-term local control. However, due to the relatively low radiation tolerance of liver     normal tissue, even using stereotactic techniques, delivery of sufficient doses for     successful local tumor control has not be achieved to date.      Carbon ions offer physical and biological characteristics. Due to their inverted dose profile     and the high local dose deposition within the Bragg peak precise dose application and sparing     of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an     increased relative biological effectiveness (RBE), which can be calculated between 2 and 3     depending on the HCC cell line as well as the endpoint analyzed.      Japanese Data on the evaluation of carbon ion radiation therapy showed promising results for     patients with HCC.      In the current Phase I-PROMETHEUS-01-Study, carbon ion radiotherapy will be evaluated for     patients with advanced HCC. The study will be performed as a dose-escalation study evaluating     the optimal carbon ion dose with respect to toxicity and tumor control.      Primary endpoint is toxicity, secondary endpoint is progression-free survival and response.   "
253015|NCT01167998|"     Malignant Melanoma is a deadly skin cancer that can be cured if diagnosed early. To date     atypical pigmented skin lesions are diagnosed by appearance alone and many moles and lesions     are excised unnecessarily and on the other hand malignant lesions are missed and diagnosed     too late. In this study a protein conjugated to a florescent dye is spread on a suspicious     pigmented lesion, the hypothesis is that this protein binds to malignant cells only and thus     with a special camera that picks up the dye we can find pigmented lesions with early     malignant transformation.   "
253002|NCT01167387|"     Postoperative infectious morbidity remain the most frequent, threatening and costly event     after major surgery. Maintenance of postoperative euglycemia might be a key factor to prevent     such complications and given the preliminary data on the positive effect of carbohydrate load     on glucose metabolism it might also be valuable in improving outcome. If this treatment will     be proved effective on relevant outcome measure such as rate of infections, it might be used     routinely and extensively because preoperative carbohydrates administration is cheap, simple     and applicable by everyone in any surgical ward.      The aim of the trial is to evaluate if the normalization of blood glucose by means of     preoperative oral administration of maltodextrine, in patients candidate to elective major     surgery, may be effective in improve surgical morbidity.   "
253003|NCT01167400|"     Exercise has been linked to cognitive health, but few older adults exercise at recommended     levels. Cybercycling may provide additional cognitive benefits due to increased motivation to     ride the interactive 3D tours. Participants will be randomly assigned to three months of     either cybercycling or traditional stationary biking; and they will complete comprehensive     evaluations before and after exercise. Older adults are expected to show significant     neuropsychological, physiological and behavioral gains.   "
253004|NCT01167855|"     The overall goal of this proposal is to examine the efficacy of a school-based asthma     telemedicine intervention in a predominately minority, low-income rural pediatric population.   "
253005|NCT01167868|"     This is a single and multiple ascending dose study in healthy male and female (of non-child     bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and     blood and urine drug levels of FosD. FosD is being developed for the treatment of rheumatoid     arthritis.   "
253006|NCT01167881|"     This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for     BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2     diabetes mellitus and insufficient glycaemic control.   "
253007|NCT01167894|"     The purpose of this study is to        -  compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg          tablets of MercK & Co. Inc, USA in healthy subjects under fasting conditions        -  monitor adverse events and to ensure the safety of subjects.   "
253008|NCT01167907|"     A nerve block catheter is a small tube placed next to a nerve through a needle, and the     needle is then removed. Numbing medicine is dripped through the tube to reduce pain sensation     from the nerve.      The purpose of this research study is to test whether the placement of a second nerve block     catheter, rather than a single injection for the saphenous nerve block will improve pain     relief and/or reduce pain medication needed after surgery enough to justify two nerve block     catheters.      There are two nerves that carry pain sensations from the ankle, the large (sciatic) nerve and     the smaller (saphenous) nerve. Patients undergoing ankle fusion or fracture surgery at Wake     Forest University typically have a nerve block catheter placed next to the sciatic nerve to     give local anesthetic (numbing medicine) for 24-72 hours. In addition, a single injection of     local anesthetic is usually performed to block the saphenous nerve for 12-16 hours     postoperatively.   "
253024|NCT01168115|"     The purpose of this study is to evaluate the performance of a near-infrared transmission     measurement in blood samples collected from healthy volunteers. We propose that NIR     spectroscopic blood glucose measurements in healthy patients are as accurate as handheld     glucometers and a Yellow Springs Instrument (YSI). We will also evaluate in vitro blood     samples spiked with pharmacological interferents to test if the spectroscopic glucose     measurement is affected by common medications.   "
253009|NCT01167920|"     This is a prospective, randomized controlled trial designed to determine whether blue tooth     and telephone technology can be utilized to successfully relaying home blood pressure     information electronically to healthcare providers so that timely and more frequent treatment     interventions can be instituted to optimize and reach goal blood pressure level for an     individual as compared to usual care. The primary study outcomes are improvement in systolic,     diastolic, and blood pressure control and time to control blood pressure. Secondary outcomes     are proportion of patients controlled to blood pressure goal at the end of the study,     adherence to blood pressure monitoring and utilization of VHC model.      If this is successful and cost-effective such technology and interventions could be utilized     on large scale to improve the care and proportion of hypertensive patients achieving goal     blood pressure in the United States.   "
253010|NCT01167933|"     The purpose of this study is to        -  compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg          tablets of MercK & Co. Inc, USA in healthy subjects under fed conditions        -  monitor adverse events and to ensure the safety of subjects.   "
253011|NCT01167946|"     Systemic Pulse Glucocorticoids have been shown to be effective in widespread Alopecia areata     but not the totalis, universalis or ophiasic type. Whether the failure is due to inadequate     dosing, inadequate frequency or other factors is a matter of debate. The investigators     decided to conduct this study using the oral pulse steroid, however with higher doses and     more frequent pulses to patients with severe forms of Alopecia areata.   "
253012|NCT01167959|"     The purpose of this study is to determine the effect of gastric banding or gastric bypass on     hypothalamic morphology and function, gut hormones and systems biology in obese subjects with     and without type 2 diabetes.   "
253013|NCT01167972|"     The main objective of the study is to determine the proportion of patients with M + mutation     status among patients with Non Small Cell Lung Cancer adenocarcinoma.   "
253014|NCT01167985|"     The effect of Antibacterial Nanoparticles, Incorporated in root canal sealer material and in     provisional restoration is going to be examined. Two different tests are planned: (1)     clinical and radiological evaluation of root canal sealer.(2) An evaluation in the laboratory     the efficacy of provisional restoration during root canal treatment.We assume, based on our     previous laboratory studies that show antibacterial properties, that the incorporation of the     nanoparticels will improve the treatment outcome.   "
253029|NCT01168180|"     The purpose of this study is to evaluate the efficacy of traditional Thai massage on pain     intensity, pressure pain threshold, muscle tension, anxiety, cervical range of motion,     patient satisfaction and side effects in the treatment of scapulocostal syndrome.   "
253030|NCT01168193|"     Surgical complications may be very serious and are often under-reported. The aim of this     study it to document and study all the postoperative complications at our department during     one year using a novel grading system.   "
253016|NCT01168011|"     This is a phase 1 study in which 2 to 72 patients with advanced cancer will receive oral     doses of rigosertib, a new investigational (unapproved) anti-cancer drug. The objective of     the study is to determine the highest dose of drug that can be given safely. The study will     start by testing a low dose. If this dose is safe, then, higher and higher doses will be     tested as long as the previous lower dose was safe. Safety will be determined by looking for     any side effects or unusual laboratory values. It is important to know the highest safe dose     so that additional studies can be done. The drug will be given in the form of capsules twice     or three times a day for 21 consecutive days of 21-day cycles.   "
253017|NCT01168024|"     The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey     Medical CINCOR™ Contrast Removal System.   "
253018|NCT01168037|"     The aim of this study is to prospectively compare the perioperative mortality severe     morbidity and the costs of endovascular versus conventional surgical repair of pararenal,     supra-renal and type 4 THORACO-abdominal aortic aneurysms.      The primary goal of the study is to demonstrate a significant drop in 30-day mortality and     life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from     the literature, that the average 30-days mortality is 3% after endovascular repair and 10%     after open surgery justifies the design of a prospective study between endovascular therapy     (250 patients (amendment) treated in 8 University hospitals with significant experience of     the technique) and open repair (660 similar patients analyzed form the national database of     the MOH).   "
253019|NCT01168050|"     NILOMEL is a phase II multicentric uncontrolled open national trial assessing the efficacy of     Nilotinib in first or second line treatment of primary melanomas , stage III unresectable     melanomas, or Stage IV melanomas with c-KIT mutation or amplification. The primary objective     is overall response rate (partial and complete response) according to RECIST 1.1 criteria,     assessed using CT-SCAN (stage IV melanoma) or MRI (unresectable melanoma) after 6 months     therapy with Nilotinib 800 mg/d. Secondary objectives include:        -  Disease control rate (complete, partial response and stable disease)        -  Metabolic response        -  Tolerance NCI CTCAE Version 3.0        -  Biomarkers associated to response and disease control.   "
253020|NCT01168063|"     H pylori eradication failure with recommended triple therapy is mainly related to antibiotic     resistance. However,IN VITRO culture of H pylori is uneasy and is not performed in routine     practice. A molecular test of antibiotic resistance easy to perform is now available. The aim     of the study was to compare eradication rates obtained with the standard treatment and with a     treatment guided by the results of the molecular detection of antibiotic resistance.   "
253021|NCT01168076|"     The objective of this study is to assist in the development of a noninvasive device for the     accurate measurement of blood glucose levels.   "
253022|NCT01168089|"     Luminous Medical, the Sponsor is developing a glucose monitor for the critical care setting.     The Sponsor's ultimate goal is to provide a near-continuous blood glucose monitor that     automatically measures glucose. In this study, Luminous will evaluate the performance of the     near-infrared measurement in blood samples collected from patients in the intensive care unit     setting.   "
253023|NCT01168102|"     The objective of this study is to assess the performance of a noninvasive device for the     detection of blood alcohol levels.   "
253025|NCT01168128|"     Canadian Critical Care Nutrition Guidelines assist health practitioners in identifying best     practices for feeding critically ill patients. However, guidelines have resulted in little     change in Intensive Care Unit (ICU) practices, possibly because barriers to change differ     between ICUs. Change may be facilitated if strategies specifically address identified     barriers. The investigators hypothesize that barriers are inversely related to nutrition     performance. Tailoring change strategies to overcome barriers to change will reduce the     presence of these barriers and lead to improvements in nutrition practice.   "
253026|NCT01168141|"     This is a prospective study in which patients with castrate-resistant prostate cancer and     bone metastases will undergo imaging, donate blood, bone marrow and urine samples, and where     possible primary tumour and bone metastatic tissue, before and during treatment with ZD4054,     an orally active specific endothelin-A antagonist. The samples will be used primarily for     biomarker studies, and it is hypothesized that these will inform on the mechanism of action     of this drug. Magnetic Resonance Imaging (MRI) will be performed to evaluate emerging     functional imaging endpoints as markers of early response in bone metastatic prostate cancer.   "
253027|NCT01168154|"     The aim of this study is to evaluate the effectiveness and the tolerability of the     Lactobacillus reuteri in the control of the diverticular disease symptoms and in the     prevention of acute diverticulitis episodes.   "
253028|NCT01168167|"     Recent clinical trials of combination antiretroviral therapy (cART) containing the first     approved integrase inhibitor (i.e. raltegravir) have demonstrated a more rapid decay of HIV-1     RNA in plasma, compared to conventional potent antiretroviral combinations. This was observed     especially during the early phase (up to week 12) following initiation of cART.      To explain this, two mechanistic hypotheses have been developed:        1. - Macrophage reservoir death hypothesis. A major source of virus production during the          second phase decay are believed to be long-lived infected cells with continuous virus          production - e.g. macrophages. An accumulation of unintegrated, episomal HIV-1 cDNAs can          promote apoptosis (Li et al. Embo J. 2001;20: 3272). In case of HIV superinfection of          such a productively infected cell, an INI-based cART may induce apoptosis and thus          contribute to a decrease in HIV RNA load during second phase decay. However, no study          has thus far addressed the consequences of INI treatment on HIV-1 cDNA species on any          cell population in vivo.        2. - Resting CD4 T-cell reservoir integration block hypothesis. Resting CD4 T-cells may          represent a substantial reservoir for HIV replication during the second phase decay as          well. A special characteristic of these cells is that HIV-1 cDNA is typically localized          to the nucleus in a not-integrated form (Chun et al., PNAS 1997;94:13193). These resting          cells likely integrate HIV-DNA upon activation and then contribute to HIV viremia and          viral spread. Conceptually, integration could be prevented by RGV, but not by RTI or PI.          An accumulation of circular episomal HIV-1 cDNA species may also be a consequence of RGV          treatment in this cell type.      Patient disposition:      To explore raltegravir-induced shifts in HIV-1 cDNA species in vivo, this non-interventional     clinical observation investigates the dynamics of the three major HIV-1 cDNA species (total     HIV-1 cDNA, HIV-1 integrants in the host cell genome, episomal HIV-1 2-LTR circles) over a     period of 4 months in two groups of patients starting off cART from a single study center.     Patients who begin cART in regular clinical routine with 2N(t)RTI plus either (n=10 patients)     raltegravir or (n=10 patients) a boosted protease inhibitor/ alternatively an NNRTI will be     offered to participate in this observation. Only patients are offered to participate in this     trial if no other antiretroviral drugs than the above mentioned and no concomitant drugs with     relevant impact on antiretroviral's pharmacokinetics are administered. At time of study     inclusion, patients should be characterised by a HIV-1 RNA load of >5,000 copies/mL and     CD4-cell count of >200/µL within 12 weeks before cART initiation.      Preliminary analyses of PBMCs from HIV-infected patients indicate that all three major HIV-1     cDNA species can be quantified by real-time PCR under these baseline conditions.   "
253032|NCT01168219|"     This phase II clinical trial is studying how well giving busulfan, fludarabine phosphate, and     anti-thymocyte globulin followed by donor stem cell transplant and azacitidine works in     treating patients with high-risk myelodysplastic syndrome and older patients with acute     myeloid leukemia. Giving low doses of chemotherapy, such as busulfan and fludarabine     phosphate, before a donor stem cell transplant helps stop the growth of cancer cells. It also     stops the patient's immune system from rejecting the donor's stem cells. The donated stem     cells may replace the patient's immune cells and help destroy any remaining cancer cells     (graft-vs-tumor effect). Sometimes the transplanted cells from a donor can also make an     immune response against the body's normal cells. Giving anti-thymocyte globulin before     transplant and giving azacitidine, tacrolimus, and methotrexate after the transplant may stop     this from happening.   "
253033|NCT01168232|"     This phase II trial is studying the side effects and how well ixabepilone works in treating     patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as     ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the     cells of by stopping them from dividing.   "
253034|NCT01168245|"     The aim of this study is to examine if combined treatment with TMS and cognitive training     (CoTra) for several weeks can produce a sustained improvement in cognitive and behavioral     symptomatology of mild to moderate Alzheimer's disease (AD) patients.   "
253035|NCT01168258|"     Background:      - Diabetic macular edema (DME) is a common condition in people with diabetes. DME occurs when     blood vessels in the eye leak fluid, resulting in swelling inside the back of the eye and     progressive vision loss. Research has shown that good blood sugar control can reduce the risk     and severity of DME. However, not all diabetic patients with poor blood sugar control develop     DME, and some patients develop DME despite excellent blood sugar control. This suggests that     other factors, such as genes or inherited traits, may predispose or protect a diabetic     patient from developing DME.      Objectives:      - To investigate genetic factors that may influence the development of diabetic macular     edema.      Eligibility:      - Individuals at least 18 years of age who have type 2 diabetes, with or without diabetic     macular edema.      Design:        -  The study will require one visit to the National Institutes of Health eye clinic.        -  Participants will be screened with a medical history and basic eye examination.          Individuals who have certain eye diseases other than DME may not be allowed to enroll in          the study.        -  Participants will provide a blood sample, and will receive fluorescein angiography (an          injection of fluorescein dye, after which a camera will take pictures of the dye as it          flows through the blood vessels in the eye).        -  No treatment will be provided as part of this protocol.   "
253036|NCT01168271|"     Malaria caused by Plasmodium falciparum continues to be a global problem with devastating     consequences. A greater understanding of the immunologic and parasitologic factors associated     with infection and disease is badly needed, and will accelerate the development of highly     protective vaccines for both mothers and children. Pregnancy malaria is associated with low     birth weight, maternal anemia, and gestational hypertension, and both inflammation and the     fetal response to infection may contribute to these poor outcomes. Childhood malaria is a     major cause of mortality, and we have found that risk of childhood malaria is related to in     utero exposure to pregnancy malaria, as well as other host factors like iron status and     constitutive cytokine levels. Pregnancy malaria is caused by a distinct parasite binding     phenotype, and as our primary hypothesis in this study we speculate that severe childhood     malaria parasites may also have distinct features. A longitudinal cohort study will be     conducted in Ouelessebougou, Mali an area of intense seasonal transmission. Up to 2000     pregnant women and their infants and 2000 children ages 0 - 3 will be enrolled and followed     to age 5 years, with clinical evaluation and periodic venous and peripheral blood samples     obtained. In addition, 2000 febrile children up to age 10 years will be enrolled at the     Ouelessebougou district health centers or the Gabriel Tour(SqrRoot)(Copyright) Pediatric     Hospital in Bamako, Mali, with acute and convalescent samples being obtained and 500 pregnant     women enrolled at the health centers and hospital in Ouelessebougou district or the Gabriel     Tour(SqrRoot)(Copyright) Hospital in Bamako for a case-control study on pregnancy malaria and     preeclampsia. Clinical, parasitologic and host response (including immunologic) endpoints     will be analyzed using appropriate statistical methods, including possible confounders, to     determine factors associated with infection and disease in pregnant woman and young children.   "
253037|NCT01168284|"     In recent years, there have been a growing number of individuals diagnosed with Autism     Spectrum Disorders (ASD). As such, this increase has expanded the number of caregivers of     children with ASD. Research has shown that having a child with an ASD is stressful for     caregivers and their families. More specifically, prior research suggests that caregivers of     children with ASD may find it difficult to maintain feelings of control and to cope with the     overall physical and emotional demands of caring for their child. A previous study of     caregivers of children with ASD found that caregivers felt a lack of personal control over     aspects of their child s condition and also found it difficult to cope with various demands     of caregiving. Furthermore, this study found that greater levels of perceived personal     control and the use of problem-focused coping strategies were associated with caregivers     adaptation to their child s condition. As such, the goal of our research is to conduct a     feasibility study using a coping effectiveness training (CET) intervention designed to     enhance perceived personal control (PPC) and coping efficacy in caregivers of children with     ASD. There has been a growing interest in developing interventions targeted at constructs     involved in the adaptation process. However, there have been few studies of interventions     targeting predictors of adaptation such as PPC and coping efficacy. Research has shown that     the CET intervention can enhance coping efficacy in several other populations. This     intervention also incorporates appraisals of one s ability to change a particular situation.     The conceptual framework for our study was adapted from Lazarus and Folkman s Transactional     Model of Stress and Coping. A cross-sectional randomized treatment-control design is proposed     to evaluate the use of a CET intervention intended to enhance PPC and coping efficacy.     Caregivers of children with ASD will be recruited from support groups, autism resource     centers, and four clinics. Participants randomized to the treatment group will be asked to     complete baseline and follow-up surveys and two 1.5-hour individualized in-person sessions.     Participants randomized to the control group will be asked to complete baseline and follow-up     surveys and two 1.5-hour individualized in-person client-centered discussion sessions. The     main outcome measures will be participation, reasons for withdrawal, participants experiences     within the intervention setting and their experiences in applying the intervention, PPC,     coping efficacy, and coping effectiveness.   "
253038|NCT01168297|"     In 1995 we conducted a cross-sectional study to identify the effects of traditional and     western environments on prevalence of type 2 diabetes mellitus (T2DM) and obesity in Pima     Indians in Mexico and the United States. The Mexican Pimas live in a remote mountainous     region and at that time had experienced little change from their traditional lifestyle.     Nothing was known about their T2DM prevalence. A similar number of non-Pima Mexicans live in     the same village. In contrast to the Mexican Pimas, the U.S. Pimas live in more westernized     society and have a high prevalence of diabetes. We found that although T2DM and obesity were     more prevalent in Mexican Pimas than non-Pimas, both Mexican groups had a significantly lower     prevalence of these disorders than U.S. Pimas. The lifestyle of the Mexican population     studied included a dramatically higher level of physical activity and a diet higher in fiber     and lower in calories derived from fat compared with the U.S. Pimas. Since the U.S. and     Mexican Pimas share a similar gene pool we concluded that even in populations genetically     prone to T2DM and obesity, their development is determined largely by environmental     circumstances.      Since 1995 the environmental circumstances of the Mexican Pimas and non-Pimas have changed.     The electrical supply to the region has increased, cars have become more prevalent and     grocery stores have appeared. The impact of these changes on T2DM and obesity has not been     examined. In light of these events, we propose to: 1) compare the current prevalence of T2DM     and obesity in Mexican Pimas and non-Pima Mexicans to that present in 1995 with the same     measures used previously, including height, weight, waist circumference, body composition by     bioelectrical impedance, oral glucose tolerance and HbA1c; 2) compare current diet, physical     activity and total energy expenditure in both Mexican Pimas and. non-Pima Mexicans using the     same methods as the 1995 study to the previous results and 3) document the frequencies of     T2DM and obesity-associated genetic variants in Mexican Pimas compared with U.S. Pimas and     non-Pima Mexicans.   "
253039|NCT01168310|"     This is a randomized, double-blind, multi-dose, parallel group trial which will assess the     pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with     COPD.   "
253040|NCT01168323|"     Two memory research findings (the spacing and testing effects) can dramatically improve     retention of learning, but they have largely have been ignored by educators. The researchers     have developed a novel form of online education (termed 'spaced education') based on these     two effects which has been shown in randomized trials to improve knowledge acquisition and     boost learning retention. Using prostate cancer screening as an experimental system, the     researchers investigated whether spaced education could durably improve clinicians'     behaviors, not just their knowledge.   "
253041|NCT01168336|"     The study aims to evaluate the safety and pharmacokinetics of extended release and standard     formulations of betahistine when administered as monotherapy and as compared to their safety     and pharmacokinetics when co-administered with olanzapine and to determine potential dose     limiting toxicities and/or drug-drug interactions affecting the pharmacokinetics or safety of     either medication, with particular emphasis on somnolence and weight gain secondary to     olanzapine treatment   "
253042|NCT01168349|"     This observational study will evaluate the clinical benefit of NeoRecormon (epoetin beta) in     daily routine practice in cancer patients with anemia. Data will be collected from patients     who are receiving chemotherapy for a solid tumor or hematological malignancy. Patients will     be followed for 28 weeks.   "
253043|NCT01168362|"     Multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of     coronary heart disease. The investigators aimed to characterize coronary artery disease in     subjects with cardiovascular risk or not, and in particular plaque natures depending on     different status of cardiovascular risk. Especially,the investigators will evaluate the     relationships between the pericardial fat and severity of stenosis as well as plaque     characteristics using logistic regression models.   "
253044|NCT01168375|"     80 diabetic patients underwent vitrectomy and had no history of Eye herpes infection,     Refractive surgery, Autoimmune disease, Immune deficiency will be randomized into two groups     (double blind)to evaluate the role of umbilical cord serum therapy on improvement of corneal     epithelial defect following diabetic vitrectomy. Both groups will take the conventional     medication including Chloramphenicol, Betamethasone, Cycloplegic eye drops besides the case     group will take umbilical cord serum eye drop in the eye operated. After surgery the corneal     epithelial defect will be measured by slit lamp.   "
253045|NCT01168388|"     Movement disorder involve recurring or constant muscle contractions causing squeezing or     twisting movement, such as hemifacial spasm, blepharospasm, cervical dystonias etc. The most     common focal dystonia was cervical dystonia in western countries according to previous     studies, which is different from China in Chinese neurologists' opinion. And there is no such     survey. So the investigators are conducting a movement disorder survey in east China to     confirm it.   "
253046|NCT01168401|"     Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage     levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with monophosphoryl     lipid A (MPL) and aluminum hydroxide (AlOH) compared to controls. Subjects will receive two     doses, by intramuscular (IM) injection, 28 days apart.      The hypotheses for this study are:        -  The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine          will be similar to the incidence of adverse events after other IM vaccines including          CERVARIX® which contains MPL and AlOH.        -  Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose.        -  The post-vaccination serum antibody responses, the number of antibody secreting cells          (ASC), including homing markers, and memory B-cell responses directed against norovirus          antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls.   "
253047|NCT01168414|"     This is a single-center, cross-over comparison parallel group randomized trial designed to     evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8     weeks each.   "
253048|NCT01168427|"     The purpose of this study is to gather evidence about the safety and feasibility of     performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office     or clinic setting rather than the traditional hospital operating room, cardiac     catheterization or electrophysiology (EP) laboratory setting.   "
253049|NCT01168440|"     VHL patients may benefit from sunitinib. This study will investigate the following objectives     :      PRIMARY OBJECTIVE        -  To determine the objective response rate according to RECIST criteria, in VHL patients          with advanced tumors or tumors untreatable by other means, and treated with sunitinib.      SECONDARY OBJECTIVES        -  To evaluate the safety and tolerability of sunitinib in VHL patients according to the          NCI-CTC criteria Version 3.0.        -  To determine the following time-to-event endpoints: overall survival, time to disease          progression, progression free survival, time to response and duration of response.        -  To evaluate quality of life in VHL patients receiving sunitinib.   "
253050|NCT01168453|"     This study was performed to ultrasonographically demonstrate the changes in relationship     between the right internal jugular vein (IJV) and an anatomical landmark in two different     head positions: neutral and rotational.   "
253051|NCT01168466|"     This study measures whether the symptoms of frontotemporal dementia (FTD) can be successfully     treated by (a) biofeedback training to increase brain blood flow, (b) biofeedback to increase     the frequency of the brain's dominant brainwave rhythm, and (c) rhythmic stimulation to     increase the brain's dominant brainwave frequency.   "
253052|NCT01168479|"     Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in     local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy     fractions. Nevertheless, the five-year biochemical relapse rate still was approximately 35%     in the high-dose arm. Therefore further dose escalation seems to be required. A feasibility     study up to appr. 85 Gy on the entire prostate has already been performed and showed     acceptable toxicity when combined with adequate position verification. Higher doses to the     entire prostate are expected to increase severe toxicity. As local recurrences only occur at     the site of the primary macroscopic tumour area the next step in increasing the dose should     be an ablative boost to the macroscopic tumour alone, while electively irradiating the rest     of the prostate to the current gold standard dose. Feasibility of this approach has been     shown for an ablative dose of 95 Gy to the macroscopic tumour within the prostate.   "
256065|NCT01889537|"     The purpose of the research is to see whether a low dose of ketamine, a medication used to     reduce pain, enhances the effectiveness of a virtual reality video game, which is used as a     form of distraction from pain during a painful burn care procedure.   "
253053|NCT01168492|"     The purpose of this study is to determine whether ketamine, midazolam, and meperidine are     more effective than midazolam and meperidine alone for procedural sedation and analgesia in     pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side     effects and the necessity of rescue doses.   "
253054|NCT01168505|"     Study to evaluate the efficacy of intravenous iron supplementation in the prevention of     anemia in patients receiving (neo)adjuvant breast cancer regimens.   "
253055|NCT01168518|"     This observational study is a non-interventional multi-centre, prospective study.      The aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing     leads. We plan to assess the acute and short term lead dislodgment rate (within the first     three months following implantation) correlated with the type of lead (active- or passive-     fixation). Further, we are collecting data related to leads handling and leads electrical     performances   "
253056|NCT01168531|"     Multimodal analgesia may be important for optimal postoperative pain treatment and     facilitation of early mobilization and recovery. This study investigated the analgesic effect     of pregabalin and dexamethasone in patients undergoing lumbar spinal surgery.   "
253057|NCT01168544|"     Vitamin D deficiency is common in older persons, in particular in residents of nursing homes.     This is mainly explained by the fact that older persons do not often go outside in the     sunshine. On top of that the capacity of the skin to synthesize provitamin D is decreased and     dietary vitamin D intake is low. Vitamin D deficiency leads to osteoporosis, falls and     fractures. To prevent morbidity and mortality due to falls and fractures it seems logical to     supplement vit D in order to correct the deficiency. The advised daily dose of vit D     supplementation is 800 IU. Several studies showed that with this dose the required serum     25(OH)D levels will not be reached.      primary objective of this study is:        -  to investigate whether with a loading dose based on body weight and baseline serum          25(OH)D level more patients reach adequate serum 25(OH)D levels compared to 800 IU a          day.        -  to determine the best consolidation treatment.      Secondary objective        -  is a loading dose based on body weight and baseline serum 25(OH)D level safe to use in          residents of nursing homes.        -  is there a relation between the increase in serum 25(OH)D level and muscle strength          (handgrip strength).        -  is there a relation between the increase in serum 25(OH)D level and mobility (2 minute          walk test).      Study design:      Randomised trial with 3 study groups:        -  Group 1a. loading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU          vit D3/month consolidation therapy.        -  Group 1b. loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU          vit D3/month consolidation therapy.        -  Group 2. 800 IU vit D3/ dag.      Study population:      Vitamine D deficient residents of nursing homes, 65 years or older.   "
253058|NCT01168557|"     Electric Impedance Tomography (EIT) is a technique based on the injection of small currents     and voltage measurements using electrodes on the skin surface generating cross-sectional     images representing impedance change in a slice of the thorax.It is a radiation free, non-     invasive and portable lung imaging technique. Impedance changes in lung ventilation as well     as in lung perfusion can be shown. To investigate lung perfusion by EIT measurements, cardiac     output measured by routinely undergone stress echocardiography at rest and stress are     compared to parameters measured by EIT.   "
253059|NCT01168570|"     Purpose of this study is to determine whether keeping SAA on normal or near normal level will     delay progression of renal failure in patients with amyloidosis secondary to FMF.   "
253060|NCT01168583|"     This study is about investigating the relationship of postoperative fluid balance,     inflammation and acute kidney injury. This is a non-interventional study (no drug     administration). The investigators will collect baseline demographic data, postoperative     fluid balance status by Intake-output data, follow routine labs and collect 1 blood sample     (0.5ml) with morning lab draws on day 1 and 5ml urine samples on day 1 and 2.   "
253061|NCT01168596|"     The purpose of the research study is to determine if rasagiline is an effective treatment for     fatigue in patients with Parkinson's disease (PD).   "
253062|NCT01168609|"     Left atrial volume (LAV) provides the significant prognostic information in the general     population and patients with heart disease, including acute myocardial infarction, left     ventricular dysfunction, mitral regurgitation, cardiomyopathy and atrial fibrillation. Large     left atrial volume, which represents chronic diastolic dysfunction, is associated with poor     outcome, regardless of systolic function. Thereby, LAV provides a long-term view of whether     or not the patient has the disease of diastolic dysfunction, regardless of whatever loading     conditions are present at the time of the examination, as the hemoglobin A1C in diabetes.     However, whether left atrial (LA) parameters could correlate with LVFP and reflect short-term     change in left ventricular filling pressure(LVFP) remains unknown. Only one article of our     team confirmed the relationship between LAV and LVFP in patients with severe mitral     regurgitation by simultaneous echocardiography-catheterization. The prior report proposed a     new parameter, LA distensibility, and disclosed its logarithmic relationship with LVFP. The     LA distensibility precisely indicated rapid change in LVFP of patients with acute severe     mitral regurgitation, and was even superior to mitral E/Em (early-diastolic mitral inflow     velocity divided by early-diastolic mitral annular velocity). As left atrial pressure rises     to maintain adequate left ventricular diastolic filling, increased atrial wall tension tends     to dilate the chamber and stretch the atrial myocardium. Therefore, the smaller left atrial     stretchability, the more pressure left atrium (LA) faces to. The first objective of this     study was to test the value of LA distensibility for assessing LVFP, particularly in patients     with acute myocardial infarction. The second objective was to assess the prognostic value of     LA distensibility.   "
253063|NCT01168622|"     The effects of race/ethnicity on platelet function and response to antiplatelet agents will     be assessed using 125 healthy subjects, 250 coronary heart disease patients treated with     aspirin, and 250 coronary heart disease patients treated with aspirin and a P2Y12 receptor     antagonist, clopidogrel or prasugrel. A minimum of 25 healthy people, 50 people taking only     aspirin, and 50 people taking aspirin and clopidogrel/prasugrel will be recruited for at     least 5 racial/ethnic groups.   "
253149|NCT01169740|"     Prospective comparison of measurement of bilirubin in jaundiced newborns by a transcutaneous     device (bilirubinometer) and laboratory analysis of blood samples.      We hypothesise that correlation of the two measurements depend on bilirubin level,     gestational age as well as postnatal age.   "
253064|NCT01168635|"     Spirometry is a recommended component of asthma diagnosis and treatment in the primary care     setting, yet few providers report its routine use for children with asthma. Misclassification     of asthma severity occurs when assessment is based on symptoms alone. This misclassification     can lead to inadequate treatment, increased morbidity, and increased healthcare     utilization/cost.      The goal of this study is to test the effectiveness of a distance learning quality     improvement program called Spirometry 360 developed by the interactive Medical Training     Resources (iMTR) group at the University of Washington Child Health Institute. The Spirometry     360 program aims to improve care for children with asthma by enhancing provider knowledge and     self-efficacy related to the use and interpretation of office-based spirometry.   "
253065|NCT01168648|"     The purpose of this study is to investigate if yoga can be an effective stress management     technique for health care personnel.   "
253066|NCT01168661|"     The purpose of this study is to investigate if treatment with yoga or mindfulness has a more     profound and longstanding effect on stress and burnout than treatment with cognitive     psychotherapy alone.   "
253067|NCT01168674|"     The primary outcome of this study is to determine if predictors of response can select a     population of patients with MDD that is effectively treatable by augmentation with     ziprasidone.      Major depressive disorder (MDD) is a broad category, including many forms of depressive     illness, including those with only a single major depressive episode, those with episodic     recurrence with intervening well states, those with chronic depressive/anxious states without     intervening euthymia, and those with manic symptoms that do not meet threshold definitions of     full mania/hypomania.      In this heterogenous, large diagnostic definition, important groups of patients do not appear     to respond well to antidepressants, and, conversely, based on observational studies, may     respond well to neuroleptics. These predictors of response have begun to be identified and     may serve to better design studies of neuroleptics in depressive illnesses.      Among these predictors of response in MDD are clinical features that are more similar to     bipolar illness than unipolar depression. These include a family history of bipolar disorder,     antidepressant-induced mania, highly recurrent depressive episodes (>5), atypical depression,     early age of onset of depression (< age 20), failure to respond to antidepressants, and     antidepressant tolerance (initial response followed by later loss of response).      The investigators propose to use these predictors to pick out patients that are more likely     to respond to Geodon for MDD. This will be the first RCT of these predictors of depressive     response applied to neuroleptics.   "
253068|NCT01168687|"     The overall goals of this study are to (1) expand knowledge about interactions of     levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in     moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to     measure postural control (which has been used as a marker of intoxication) and the effects of     levetiracetam on postural control.   "
253069|NCT01168700|"     Many studies have addressed the relationship between metabolic syndrome and cardiovascular     disease. Risk factors include abdominal obesity, insulin resistance, abnormal lipid profile     and hypertension. It is proposed that this condition leads to an increase in the production     of inflammatory substances and endothelial dysfunction.      New therapies have been studied to improve control of metabolic disorders and reduce the     endothelium damage. Aged garlic extract (Kyolic®) is a promising intervention that has     antithrombotic and antioxidant properties. At the moment there is not data about the effects     of supplementation with AGE in the endothelial function of patients with metabolic syndrome.     Thus, the purpose of this study is to investigate if the supplementation with Kyolic® can     alter the plasma levels of inflammatory markers, insulin and the endothelial function of     patients with metabolic syndrome.      Methods and design: A randomized, cross over, double-blind, placebo-controlled trial will be     performed to assess the effects of 1.2 g of Kyolic in insulin resistance and endothelial     function of 46 patients with diagnosis of metabolic syndrome. The participants will be     recruited from the primary care centers from E.S.E ISABU Bucaramanga. All subjects who meet     the inclusion criteria will be randomly assigned to two periods of 12 weeks (Kyolic and     placebo). Control visits will be programmed monthly to verify compliance and the presence of     adverse events. Outcome variables (endothelial function assessed by flow mediated     vasodilation, inflammatory markers, insulin plasma levels) will be evaluated at the initial     visit and after 12 and 24 weeks of treatment.   "
253070|NCT01168713|"     Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in     the treatment of adults with moderate to moderately severe community-acquired bacterial     pneumonia.   "
253071|NCT01168726|"     Excessive college student drinking represents an important public health problem for both the     students themselves and those with whom they interact. The objective of this research is to     better understand how to reduce such high-risk drinking by improving prevention and treatment     programs, which will provide an overall public health benefit. Subjects in the study will be     randomized to one of two brief intervention conditions or an education-only control     condition. It is hypothesized that those in the intervention conditions will report greater     reductions in alcohol use and alcohol-related problems than those in the control condition.   "
253072|NCT01168739|"     The purpose of this study is to determine whether dietary quercetin supplementation effects     thermotolerance and heat acclimation in human subjects exposed to exercise/heat stress.      Specific Aim I. To determine if quercetin in combination with repeated bouts of thermally     stressful exercise will impact intestinal barrier function. The investigators will examine     urinary lactulose excretion, plasma endotoxin,plasma quercetin, inflammatory cytokines (TNF-a     & Il-6), anti-inflammatory cytokines (Il-10), and HSP70 and HSF-1 content of peripheral blood     mononuclear cells.      Specific Aim II. To determine whether quercetin's suppresses the ability of human subjects to     acclimate to exercise/heat stress. The investigators will examine body temperatures, heart     rates, physiological strain, sweat and plasma volume responses to standardized heat tolerance     tests.   "
253073|NCT01168752|"     The purpose of this study is to determine the maximum tolerated dose of Debio 0932 when     administered orally, every-other-day or daily during the first 30 days, in patients with     solid tumours or lymphoma.   "
253150|NCT01169753|"     The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to     control fatigue in patients with CML. The safety of this drug will also be studied.   "
253074|NCT01168765|"     Building from existing intervention strategies designed for the Mexican American population     entitled Tu Salud Si Cuenta(TSSC) or Your Health Matters. This intervention highlights in the     media successful role models who have changed their food choices and physical activity     levels. In addition, the intervention designs environmental changes to help community members     carry out recommended behavior change strategies. The purpose of this study is to test the     efficacy of the outreach elements of the Tu Salud Si Cuenta (TSSC) media campaign, a physical     activity and healthful food choice intervention among Mexican Americans in the Lower Rio     Grande Valley to achieve behavioral and clinical outcomes.   "
253075|NCT01168778|"     The excessive use of outpatient antibiotics in the pediatric population has contributed to     the rapid development of resistance in many strains of Streptococcus pneumoniae. Research has     shown that community-based interventions may have a modest impact on reducing the injudicious     use of antibiotics in children. However, since the actual prescribing of antibiotics is done     by physicians and research has shown that physician-parent communication patterns during     pediatric visits for acute respiratory tract infections (ARTI) strongly influence antibiotic     prescription rate, it is crucial to develop effective interventions aimed specifically at     them.      The overall goal of this study is to improve physician-parent communication patterns during     visits for pediatric ARTI and, ultimately, to decrease rates of antibiotic prescribing for     these illnesses in children.   "
253076|NCT01168791|"     This is an international, randomized, double-blind, placebo-controlled trial to evaluate the     clinical efficacy of palifosfamide-tris administered with doxorubicin in combination,     compared with doxorubicin administered with placebo in front-line patients diagnosed with     metastatic soft tissue sarcoma (STS).   "
253077|NCT01168804|"     The purpose of this study is to evaluate efficacy and safety of the combination regimen of     bortezomib-bendamustine-dexamethasone in patients with relapsed or refractory multiple     myeloma   "
253078|NCT01168817|"     This study examines the efficacy and safety of the combination treatment BAY60-4552 plus     vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy     with PDE5 (Phosphodiesterase 5) inhibitors.      Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of     the study to assess the effect of PDE5 inhibitor therapy given alone.      Patients with an insufficient therapeutic response to vardenafil alone will enter the next     part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3     chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone,     or placebo. Neither patient nor the treating physician will know which treatment is given     (double-blinded design).This part of the study will last four weeks Patients will have to go     to the clinic/hospital for 7 visits during the 8 weeks.   "
253079|NCT01168830|"     First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety   "
253091|NCT01168986|"     This study is comparing the effectiveness of a mechanical manual therapy device to a specific     exercise to no treatment in individuals experiencing neck pain. We are interested in the     effects of the interventions on neck pain, disability related to neck pain, and pain     sensitivity.   "
253080|NCT01168843|"     Computer Program for Evaluation of the Symmetry between the Primary Sulci of the Two Fetal     Brain Hemispheres Using 3-dimensional Ultrasound Planes      This retrospective study is based on the computerized analysis of the orthogonal fetal brain     planes.      The images are obtained from the digital archive of the fetal sonographic examinations done     in Bnai Zion Medical Center.      In addition, midsagittal measurements of fetal head will be obtained from this archive of     3-dimensional images.      Study measurements will provide the quantitative parameters of normal fetal brain sulcation.     Normal fetal head growth in midsagittal plane will be studied also.   "
253081|NCT01168856|"     This observational long-term follow-up study will assess the persistence of direct acting     antiviral (DAA) resistant mutations and the durability of sustained virological response in     patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up     to 5 scheduled monitoring visits for blood sampling during an observational period of up to     36 months.   "
253082|NCT01168869|"     Some myocardial infarctions (MI) occur as the first manifestation of coronary artery disease.     These are termed 'unheralded' events as they have not been preceded by other forms of     coronary artery disease. Unheralded MIs are important because of the high likelihood of     missed opportunities for prevention. The proportion of MIs that are 'unheralded' is unknown.      This study aims to quantify the proportion of MIs that occur 'unheralded' and also give an     estimate of the incidence of 'unheralded' MI in the UK, compared to 'heralded' MI and those     with angina of recent onset (MIs with premonitory symptoms).   "
253083|NCT01168882|"     The purpose of the study is to determine the safety and tolerability of RGB-286638, a novel,     multi-targeted kinase inhibitor, administered to patients with selected, relapsed or     refractory hematological malignancies.   "
253084|NCT01168895|"     The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin     after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75     mg dose will be administered for the first time using a new high dose strength (i.e. one     capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations     will focus on local tolerability in the lung and evaluate whether the patient can inhale the     higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how     the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this     study will be used to decide whether the new dose strength is suitable for larger clinical     trials planned for the COPD patients population.   "
253098|NCT01169077|"     Malaria, a disease responsible for over one million deaths per year, is caused by a germ     spread by mosquito bites. The purpose of this study is to evaluate a vaccine designed for the     prevention of malaria caused by the parasite, Plasmodium falciparum, and to evaluate the     device used to give the vaccine. This study will provide information on how safe, effective,     and tolerable the vaccine is in healthy adults. The participants will be assigned, by chance,     to receive 3 doses/shots of the vaccine or a placebo (substance that contains no medication)     by injection in the upper arm. Study participants will include 39 healthy adults aged 18-40     years who have not been exposed to malaria and who will enroll at the Emory Vaccine and     Treatment Evaluation Unit in Atlanta, Georgia. Study procedures include physical exams and     several blood samples. Participants will be involved in the study for approximately seven and     one half months.   "
253085|NCT01168908|"     This study, supported by Charley's Fund, Inc., is being done to determine if the drug     Revatio®(also known as Sildenafil), as compared to placebo (an inactive substance that looks     like the study drug, but contains no medication), improves heart function in people with     Duchenne Muscular Dystrophy and Becker Muscular Dystrophy (DBMD).      In people with DBMD, dystrophin is not present or lacking in heart and muscle. This is     associated with abnormalities in an enzyme called neuronal nitric oxide synthase or nNOS,     and leads to decreases in cyclic GMP, which is necessary for proper function of those     muscles. Revatio blocks an enzyme called phosphodiesterase 5 (PDE5), and helps to restore the     normal amounts of cyclic GMP. The purpose of this research is to determine if Revatio is safe     for people with DBMD and if it can improve heart function.      Hypothesis : PDE5 inhibition, with the use of Revatio, will improve cardiac function in     patients with DBMD.   "
253086|NCT01168921|"     The goal of this clinical research study is to learn if eltrombopag can help to increase the     number of platelets in patients with CLL. The safety of this drug will also be studied.   "
253087|NCT01168934|"     This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over     single-dose study to test the absolute bioavailability of oral crizotinib formulation to IV     formulation in healthy adult volunteers. Fourteen (14) subjects will be enrolled to obtain at     least 12 evaluable subjects who complete the study. Each subject will receive two treatments     (A and B) with a washout period of at least 14 days between each treatment.   "
253088|NCT01168947|"     Sodium loading during hemodialysis treatment is common and may contribute to increased     interdialytic weight gain and hypertension. Excessive use of isotonic saline (containing 0.9%     sodium chloride) is one of the factors that may cause sodium loading. During each     hemodialysis session, approximately 400 mL of isotonic saline fluid, representing 1.4 grams     of sodium, is used to prime and rinse the extracorporeal circuit, and is often administered     to the patient. Switching to a non sodium-containing priming and rinsing fluid could allow     for removal of the equivalent amount of sodium.      Switching to a non sodium-containing solution for the priming and rinsing of the     extracorporeal circuit can contribute to increased sodium removal during the dialysis     treatment and allow for reduced interdialytic weight gain, reduced thirst, and improved blood     pressure control.   "
253089|NCT01168960|"     Cognitive-behavioral therapy (CBT) is an effective treatment for alcohol dependence, but     little is known about how CBT works to achieve these effects. Although several possible     mechanisms have been proposed to explain the effects of CBT, it is rare that more than one     mechanism is studied. However, it may be the case that similar outcomes (e.g., abstinence)     may be reached through multiple paths. Therefore, essential to conducting work on behavioral     change mechanisms is distinguishing different courses or paths and moderating influences     (Kazdin, 2007). In the present study, we will focus on 2 key mechanisms posited to underlie     the effectiveness of CBT specifically, increasing self-efficacy and self-confidence and     reducing positive outcome expectancies for alcohol use, and 2 key mechanisms posited to     underlie the effectiveness of a wide range of therapeutic interventions, increasing the     therapeutic alliance and reducing/regulating negative emotional states. For the present     study, participants will be 72 alcohol dependent men and women who agree to participate in a     12-week trial of CBT for alcohol dependence. In addition, comprehensive research assessments     will be conducted with patients at baseline, end of treatment, and 3-months posttreatment.      Specific Aim 1. To examine the within-treatment week-to-week relationship between ratings of     4 key therapeutic mechanisms and alcohol involvement (operationalized as percent days     abstinent {PDA} and drinks per drinking day {DDD}) during treatment. It is hypothesized that     self-efficacy, outcome expectancies, therapeutic alliance (as rated by the patient and     therapist), and negative affect assessed after any given treatment session will each predict     alcohol involvement during the following week. Exploratory analyses also will investigate the     relationship of a given week's alcohol involvement on each of the four key variables as     assessed the following week.      Specific Aim 2. To examine profiles of the four key mechanisms over the course of treatment     in relation to alcohol involvement during treatment and during the 3-month follow-up period.     These analyses will be descriptive/exploratory. It is expected that profiles will emerge with     the key mechanisms that are associated with decreased alcohol involvement (for example, when     the alliance is relatively strong throughout treatment or when the alliance grows stronger     over the course of treatment, or when positive outcome expectancies grow weaker over the     course of treatment, etc.). Similarly, it is hypothesized that profiles will emerge that are     associated with little improvement in alcohol involvement (for example, when negative affect     is relatively high throughout treatment or when self-efficacy weakens over the course of     treatment).   "
253090|NCT01168973|"     The purpose of the study is to compare the survival of participants who receive chemotherapy     and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior     first line platinum-based chemotherapy.   "
253092|NCT01168999|"     The purpose of this study is to determine whether a novel placebo for comparison to spinal     manipulation is believable and creates similar expectation for treatment effectiveness as the     studied spinal manipulation technique. Additionally, we wish to compare outcomes related to     low back pain, function, and pain sensitivity between people receiving the placebo, spinal     manipulation, and no therapy.   "
253093|NCT01169012|"     This is a non-blinded, non-randomized pharmacokinetic study to determine the oral     bioavailability of clofarabine, and the effect of cimetidine on clofarabine pharmacokinetics     in patients with poor-risk acute leukemias and myelodysplastic syndrome (MDS).   "
253094|NCT01169025|"     Often, patients transported by aeromedical systems do not receive enough medication to     control and relieve their pain. The purpose of this study is to determine if pain treatment     with intravenous (IV) ketamine is a better way to treat aeromedical patients' pain than the     current treatment practices.   "
253095|NCT01169038|"     Sarcoidosis is a granulomatous disease for which the molecular and immunologic association     with mycobacteria continues to strengthen. The investigators are interested in conducting a     proof-of-concept investigation of the effects of antibiotics on sarcoidosis resolution. The     investigators hypothesize that pulmonary sarcoidosis will improve faster if patients are     given antimycobacterial therapy, in addition to their standard therapy.   "
253096|NCT01169051|"     There is data to support an association between impaired preoperative endothelial function     and adverse postoperative outcome. This study will investigate the potential association     between perioperative statin use and improved perioperative and long-term cancer outcome     amongst thoracic surgery patients undergoing lung or esophageal resection.   "
253097|NCT01169064|"     A common concern in any surgical procedure is the occurrence of infection. Silver-containing     treatments are popular and used in wound treatment; however, there is presently little     evidence of the effectiveness of silver-containing treatment for the prevention of     obstetrical wound infection. We plan to investigate the rate of infection in women     experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing     the infection rate based on a randomized choice of silver-containing wound dressings to soft     cloth adhesive wound dressings.   "
253099|NCT01169090|"     The purpose of this study is to evaluate the safety and efficacy of a range of doses of     SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin     alone.   "
253100|NCT01169103|"     Teenagers and adults who are overweight or obese have an increase in fat in the abdomen,     which increases their risk for diabetes and heart disease. Reducing abdominal fat is     important to reduce risk for diabetes and for heart disease. Overweight teenagers also have     low levels of growth hormone compared to normal weight teenagers, and teenagers with the     lowest growth hormone levels also have the greatest abdominal fat. In children who are unable     to make growth hormone for other reasons, giving back growth hormone leads to a decrease in     abdominal fat. We are studying whether giving growth hormone in small doses to overweight     teenagers can change body composition. We hypothesize that growth hormone will cause     abdominal fat to decrease and reduce the risk markers for diabetes and heart disease.   "
253101|NCT01169116|"     Patients with single brain metastasis without other metastatic site have a better prognosis,     and they need a better brain metastasis control. For non-resectable and non-radiosurgical     brain metastasis, the gold standard treatment is whole-brain irradiation with 30 Gy in 10     fractions, but the local control is not achieved in most of the cases. This study investigate     the possibility to increase radiation dose in this metastasis with exclusive hypofractionated     stereotactic radiotherapy.   "
253102|NCT01169129|"     Patients in good general condition with resectable brain metastases, looks better with more     intense treatment of metastases. This local treatment has been accomplished with surgery or     radiosurgery. However, there are no randomized studies comparing these two types of     treatment. The purpose of this study is to make this.   "
253103|NCT01169142|"     Supplementation of Vitamin D in those with low levels will increase the level and result in     some improvement in health and psychopathology measures.   "
253104|NCT01169155|"     Specific Aim 1 is to test the hypothesis that there are specific characteristics of a voice     smoke alarm (i.e., use of child's first name, behavior commands in the message content, use     of mother's voice, and stimulus frequency) that will awaken children 5-12 years old in stage     4 sleep. The successful children's alarm will be tested among adult subjects to evaluate     effectiveness across the age spectrum.      Specific Aim 2 is to test the hypothesis that there are specific characteristics of a voice     smoke alarm (i.e., use of mother's voice and behavior commands in the message content) that     will result in successful completion of simulated escape behaviors by children 5-12 years old     after awakening from stage 4 sleep. The successful children's alarm will be tested among     adult subjects to evaluate effectiveness across the age spectrum.   "
253105|NCT01169168|"     In this study patients with        1. chronicle liver diseases             -  primary biliary cirrhosis             -  primary sclerosing cholangitis             -  alcoholic liver cirrhosis             -  hepatitis b or C             -  Wilson's disease             -  cryptogenic cirrhosis        2. Septic Inflammatory Response Syndrome (SIRS)             -  sepsis             -  septic shock        3. patients after lysis      should be included      Blood samples will be gathered from the patients to measure fibrinogen with 5 different     methods.      The methods are:        -  Clauss fibrinogen        -  PT-Derived fibrinogen        -  immunoturbidimetric method        -  heat-precipitated fibrinogen        -  Schulz fibrinogen      The result of these tests will be correlated with laboratory values which are gathered in     routine and the clinical outcomes.   "
253106|NCT01169181|"     The procedure involves: (1) assisted hand movement by a mechanical device, (2) mechanical     vibration applied to the surface of the forearm, and (3) stimulation of the brain with either     transcranial magnetic stimulation (TMS) or transcortical direct current stimulation (DCS).     These 3 components of the procedure are carried out simultaneously. Each subject will be     evaluated pre- and post-treatment with several clinical tests of functional movement. The     hypotheses of this project are that the AMES+rTMS and AMES+tDCS procedures are safe and will     enable most of the stroke patients to recover finger extension.   "
253107|NCT01169194|"     The investigators are doing the research to discover genes that cause Inflammatory Bowel     Disease (IBD) specifically in the African American population. Who May Join This Study?     Blacks / African Americans with or without Crohn's disease or ulcerative colitis.      If you agree to join the study, the investigators ask that you give us information about your     health. The investigators will also ask you to give us a blood sample so that they may     discover the genes that cause IBD. The blood sample may be collected at Johns Hopkins or any     local facility convenient to you.   "
253108|NCT01169207|"     This research is being done to find out why Inflammatory Bowel Disease (IBD) (i.e., Crohn's     disease and ulcerative colitis) occurs in individuals and in families. Recently the     investigators and other researchers have found a gene (DNA) that when changed, gives people a     higher risk for developing IBD or other inflammatory diseases like IBD. By doing this     research, scientists and doctors will study the cells in the blood to see how the gene-change     affects the way the blood cells' immune system works.   "
253109|NCT01169220|"     This study will compare two strategies for bowel cleansing prior to inpatient colonoscopy:     the entire preparation taken the night before the procedure versus half the preparation taken     the night before the procedure, and the other half taken the morning of the procedure.   "
253110|NCT01169233|"     The success of human expedition missions critically depend on the ability of the crew to be     alert and maintain high levels of cognitive function while operating complex, technical     equipment. Optimal human health, performance and safety during space flight requires     sufficient sleep and synchrony between the circadian pacemaker—which regulates the timing of     sleep, endocrine function, alertness and performance—and the timing of the imposed sleep-wake     schedule.      Crewmembers of the 105-day simulation study will be required to work one night shift every     sixth night. This schedule will likely result in sleep loss and circadian misalignment,     especially when lighting conditions are similar to those that crewmembers experience during     spaceflight. External mission controllers will work 24-hour shifts, also resulting in both     sleep loss and circadian misalignment.      It has been well documented in laboratory and field studies that both working the night shift     and working extended duration shifts result in decrement alertness, performance and mood. In     addition to the negative effects that night shift work has on alertness, performance and     mood, shift work causes significant short and long-term health problems. Shift workers,     particularly night shift workers who invert their normal sleep/wake schedule, suffer for     several reasons. First, their endogenous circadian rhythms and the imposed sleep/work     schedule are typically out of phase. This is similar to the experience of jet lag. However,     while environment cues (e.g., sunrise, sunset, the timing of meals and sleep) enable     travelers to adapt quickly to a new time zone, crewmembers in the 105-day simulation will be     unable to do so because they will only spend one night of every five working. When working     the night shift, the timing of meals, work, and sleep will therefore be out of phase with the     normal entrained phase of the circadian timing system. Ingestion of meals at an inappropriate     circadian phase results in impaired metabolism, likely underlying the gastrointestinal and     metabolic problems experienced by shift workers. Second, this circadian misalignment leads to     a substantial loss of sleep efficiency during the (daytime) sleep period, independent of, and     in addition to, environmental obstacles to sleep (e.g., noise, light, other crewmembers).     Third, misalignment of circadian phase coupled with sleep loss will each result in     deterioration of alertness and impairment of performance during the night. Since these     adverse effects are particularly acute on the first night of work, the plan for crewmembers     on the Mars 105 mission to work the midnight shift every sixth night will subject them     repeatedly to the performance impairments associated with acute circadian misalignment and     acute sleep deprivation.      Lighting Countermeasure. Our group at the Harvard Medical School has successfully developed     and tested effective photic countermeasures to alleviate circadian misalignment and improve     alertness, performance and mood in night shift workers. The most effective countermeasure to     circadian alignment is appropriately-timed and sufficiently intense light. Light also acutely     improves alertness, performance and mood. Most recently it has been reported that short     wavelength light has been shown to be most effective for both resetting circadian rhythms and     acutely improving performance during night work via antecedent suppression of the soporific     hormone melatonin.      These photic countermeasures have been tested in individual subjects living in laboratory     simulations (Countermeasures readiness level/Technology readiness level 7; Evaluation with     human subjects in controlled laboratory simulating operational spaceflight environment). The     next critical step is to evaluate our countermeasures in an operational simulation of space     flight that includes study of the interaction among crew members in a high fidelity     simulation (Countermeasures readiness level/Technology readiness level 8; Validation with     human subjects in actual operational spaceflight to demonstrate efficacy and operational     feasibility).      Adequate sleep and circadian alignment are critical to maintaining the health and performance     of expedition mission crewmembers. Testing of the developed lighting countermeasure in a high     fidelity operational environment imitating the conditions of a future expedition mission     (e.g., to Mars) is critical to ensure countermeasure readiness and to reduce the risk of     human performance errors due to factors related to circadian disruption, sleep loss and     fatigue. Development and testing of this photic countermeasure for mission controllers     working 24-hour shifts will further ensure the success of the future long duration expedition     missions.   "
253111|NCT01169246|"     Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple,     dual or triple chamber ICD.   "
253112|NCT01169259|"     The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial in 25,871     U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000     IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer,     heart disease, and stroke in people who do not have a prior history of these illnesses.   "
253113|NCT01169272|"     Sorin Group has developed a new atrial lead which is under evaluation during this study. The     SonR atrial lead presents a new sensor in the tip of the lead and allows a new feature;     interventricular (VV) and atrioventricular (AV) delay (VVD and AVD) optimization.      The new RV autothreshold algorithm has been implemented in the CRT-ICD and will help the     physician in his diagnosis avoiding potential lost of capture.      The ICD device has also the capability to be remotely interrogated through the remote     monitoring system whose performances will be reported during the study.      Finally, the study will report the electrical and handling performances of the new left     ventricular lead.   "
253134|NCT01169545|"     The primary purpose of this study is to examine how vulnerabilities in psychological and     social situations affect financial quality of life.   "
253114|NCT01169285|"     The purpose of the study is to test the efficiency and efficacy of the Distress Thermometer     of patients admitted to the tertiary Burn and Wound Center. The American Cancer Society and     the National Comprehensive Cancer Network published treatment guidelines in 2005 adopting the     use of the Distress Thermometer as the preferred adjunct assessment tool of a patient's     emotional well-being. A literature search provided extension of the tool to a Cardiac     Follow-up Clinic. The Distress Thermometer is currently used with oncology patients at Saint     Elizabeth.      The emotional well being of patients and their significant others is a hallmark of wholistic     care. The simple Likert scale of 0-10 has a trigger for further assessment and/ or     intervention at four. The validity testing of the tool was done against the Hospital Anxiety     and Depression Scale (HADS) and the Brief Symptom Inventory (BSI-18).      The purpose of this study is to measure the efficiency and efficacy of the documentation of     the Distress Thermometer to patients admitted to a tertiary Burn and Wound Care Center. The     frequency of the documentation will be counted and type of documentation will be categorized.   "
253115|NCT01169298|"     To determine the maximum tolerated dose of lenalidomide in patients with adult T-cell     leukemia-lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) who have previously received     therapy for ATL and PTCL   "
253116|NCT01169311|"     Trial Objectives      The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid     and Prolapse Stapling Set:      overall performance defined by the successful creation of a normal staple line safety as     measured by the 30 day incidence of adverse events.   "
253117|NCT01169324|"     The purpose of this prospective, participant-blinded trial is to determine the changes in     sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS)     surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease     (PD), tremor, or dystonia. Our preliminary observational data suggest that unilateral     subthalamic nucleus (STN) DBS improves subjective sleep quality in PD patients 6 months after     the procedure. The cause of this improvement in sleep quality is unknown, and this study     proposes the use of polysomnography (PSG) to test whether the improvement in sleep is     independent of improvement in night-time mobility associated with DBS treatment of the motor     symptoms of PD, tremor, or dystonia.   "
253174|NCT01170078|"     This study assessed the comparability of the pharmacokinetics (PK) of epoetin following     intravenous administration of Hospira Epoetin and Epogen/Epoetin Alfa (Amgen) in patients     with chronic renal failure receiving hemodialysis treatment.   "
253175|NCT01170091|"     Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome     Patients: An Open-Label, Postmarketing Surveillance Study   "
253119|NCT01169350|"     This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans     to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue     sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic     procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to     find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors     predict how well a patient will respond to treatment.   "
253120|NCT01169363|"     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the     laboratory may help doctors predict how well patients will respond to treatment.      PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from     older patients with acute myeloid leukemia treated with cytarabine-based therapy.   "
253121|NCT01169376|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in young patients with neuroblastoma.   "
253122|NCT01169389|"     This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a     hyaluronic acid supplement) administered immediately following the completion of knee     arthroscopy.   "
253123|NCT01169402|"     Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support     children who suffer heart or lung failure until whatever illness caused that failure can be     treated and reversed. While on ECMO, children are at increased risk of infection, including     fungal infection. Treatment for fungal infection includes not only antifungal medications but     also removal of any large intravenous (IV) lines. Since ECMO requires large IV lines, proper     treatment of fungal infections would be difficult if not impossible. The investigators     believe that giving prophylactic antifungal medication to all children on ECMO may prevent     fungal infections from developing in the first place.      Fluconazole is an antifungal medication that works well against the most common fungal     infections and has been shown to be safe in children. Unfortunately, the ECMO machine has the     potential to significantly alter the drug levels of medications so the investigators do not     know the proper dose of Fluconazole to give children on ECMO. Standard dosing of fluconazole     is 12mg per kilogram of body weight given intravenously once daily. Based on preliminary data     and modeling from other studies, the investigators think 25mg per kilogram given once weekly     will achieve proper drug levels to prevent fungal infections. The investigators have obtained     FDA approval to give this dose of fluconazole to children on ECMO who are enrolled in the     study. Blood samples will be collected at specific times around the first and second     fluconazole doses to describe the PK and drug extraction by the ECMO circuit.   "
253135|NCT01169558|"     This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5     mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based     chemotherapy as first line treatment in participants with metastatic cancer of the colon or     rectum. The anticipated time on study treatment is 3-12 months.   "
253136|NCT01169571|"     The objective of this study is to characterize the hemodynamic effects of Precedex     (dexmedetomidine (DEX)) during 3 loading-dose paradigms in mechanically ventilated     post-surgical subjects in an intensive care setting.   "
253164|NCT01169948|"     Recent advances in technology have resulted in the development of scanners that can n image     the heart arteries within 10 to 20 minutes but without the need for admission to hospital or     insertion of catheters. This means that coronary heart disease may be more readily identified     (or ruled out) and allow better diagnosis and treatment of patients with symptoms suggesting     coronary heart disease. Here, we propose to assess the latest and most powerful scanners to     see if it can accurately diagnose the extent of coronary artery disease and facilitate the     planning of heart surgery.   "
253124|NCT01169415|"     Purpose and Objective:        1. To compare the effects of either an abbreviated or protracted taper of dexamethasone on          functional capacity in newly diagnosed glioblastoma multiforme (GBM) patients.        2. To compare neurocognitive function in newly diagnosed GBM patients receiving either an          abbreviated or protracted taper of dexamethasone.        3. To compare skeletal muscle strength in newly diagnosed GBM patients receiving either an          abbreviated or protracted taper of dexamethasone.        4. To examine the association between functional capacity and neurocognitive function and          patient-reported measures (i.e. quality of life, fatigue, etc.) in newly diagnosed GBM          patient on either an abbreviated or protracted taper of dexamethasone.        5. To examine the association between functional capacity and neurocognitive function and          body composition measures (body-mass index, etc.) in newly diagnosed GBM patient on          either an abbreviated or protracted taper of dexamethasone.        6. To examine the association between functional capacity and neurocognitive function and          biochemical metabolic measurements in newly diagnosed GBM patient on either an          abbreviated or protracted taper of dexamethasone.      All study endpoints will be assessed at three timepoints as follows: (1) initial assessment     after surgery in the hospital, (2) second assessment at initial clinical visit at the Preston     Robert Tisch Brain Tumor Center (PRT-BTC) at Duke, approximately 1 week post-operatively, and     (3) third assessment at second clinical visit in the PRT-BTC at Duke, approximately 10 weeks     post-operatively and after completion of radiotherapy. An additional fourth assessment will     be obtained at 4 weeks post-operatively if the subject is undergoing radiotherapy here at     Duke.   "
253125|NCT01169428|"     The purpose of this study is to determine whether a 12 week Mindfulness-Based Weight Loss     Maintenance (MBWLM) intervention is effective in maintaining recent loss of 10% or more of     initial body weight.   "
253126|NCT01169441|"     The recent expansion of indications for implantable cardioverter defibrillators (ICDs) has     changed the population of patients being implanted. Younger and healthier patients are now     being implanted for primary prevention of sudden cardiac death. Due to the younger     population, the likelihood of the lead failing during the lifetime of the patient is higher     and also more likely to need extraction. To reduce the risk of the lead extraction procedure     and therefore reduce the number of abandon leads, ICD lead manufacturers are designing leads     to offer improved chronic extractability to reduce the morbidity and mortality during these     procedures.   "
253127|NCT01169454|"     The purpose of this study is to explore two currently accepted methods of intracranial     pressure (ICP) management through cerebral spinal fluid (CRF) drainage for patients diagnosed     with subarachnoid hemorrhage (SAH). This is a randomized observational study of two     physician-prescribed approaches to managing ICP monitoring and CSF drainage for SAH patients.     The study will enroll only those patients who have ICP monitoring. Because this is an     observational study, there are no physical risks to the patient, the only risk is loss of     confidentiality.   "
253128|NCT01169467|"     The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in     addition to the current standard-of-care for sedation.   "
253129|NCT01169480|"     The aim of this study is to investigate if giving a massage impacts the mental state of a     massage therapist, including depression, anxiety, and stress . It is speculated that feelings     of depression, anxiety and stress will reduce following the giving of a massage.   "
253176|NCT01170104|"     To evaluate the time to progression of the combination therapy of Transcatheter Arterial     Chemoembolization (TACE) and sorafenib in patients with previously untreated advanced or     metastatic hepatocellular carcinoma.   "
253177|NCT01170117|"     Anorexia Nervosa (AN) is a serious illness associated with substantial morbidity and     mortality. Weight restoration is a treatment priority, and better treatments are needed.   "
253130|NCT01169493|"     Heart failure (HF) affects 5 million Americans and is responsible for more health-care     expenditure than any other medical diagnosis. Approximately half of all HF patients have     electrocardiographic prolongation of the QRS interval and ventricular dyssynchrony, a     perturbation of the normal pattern of ventricular contraction that reduces the efficiency of     ventricular work. Ventricular dyssynchrony is directly responsible for worsening HF     symptomatology in this subset of patients. Resynchronization of ventricular contraction is     usually achieved through simultaneous pacing of the left and right ventricles using a     biventricular (BiV) pacemaker or implantable cardioverter-defibrillator. Clinical trial     evidence supporting the use of BiV pacing in patients with prolonged QRS duration was     obtained almost exclusively in patients with a left bundle-branch block (LBBB)     electrocardiographic pattern. Recent evidence suggests that resynchronization of ventricular     contraction in patients with LBBB can be obtained by univentricular left ventricular pacing     with equal or superior clinical benefits compared to BiV pacing. Animal studies suggest that     ventricular resynchronization can be obtained in subjects with right bundle-branch block     (RBBB) through univentricular right ventricular pacing. No clinical trial evidence exists to     support the use of BiV pacing in patients with RBBB. Thousands of patients with symptomatic     HF and RBBB currently have univentricular ICDs in place for the prevention of sudden cardiac     death. Most of these devices are currently programmed to avoid RV pacing. We aim to determine     if ventricular resynchronization delivered through univentricular RV pacing improves symptoms     in patients with RBBB and moderate to severe HF who have previously undergone BiV ICD     implantation for symptomatic heart failure. We further aim to determine if ventricular     resynchronization improves myocardial performance and ventricular geometry as detected by     echocardiographic measures and quality of life for patients with HF and RBBB. We hypothesize     that RV univentricular pacing delivered with an atrio-ventricular interval that maximizes     ventricular synchrony is equivalent to BiV pacing for improvement in cardiac performance, HF     symptoms, and positive ventricular remodeling in patients with HF and RBBB.   "
253131|NCT01169506|"     Sublingual positioning of a silicon capillary system is applied. After 15 min, while the     individual is in resting position with closed mouth and normal tidal breathing through the     nose is performed, the silicon capillary system is connected to a capnometer and CO2 tension     is measured.      The investigators hypothesis is that this setup offers a non-invasive assessment of     ventilatory efficiency with similar accuracy as arterial PCO2.   "
253132|NCT01169519|"     Patients with single ventricle anatomy undergo staged surgical palliation. The result is an     in series circulation with pulmonary blood flow and cardiac output directly related to     pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the     single ventricle palliation results in continued long term attrition. Elevated pulmonary     vascular resistance and impaired systemic ventricular function are important risk factors for     failure of single ventricle palliation.      Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in     the pressure overloaded right ventricle.      The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of     sildenafil in single ventricle patients following stage II and III surgical palliation.   "
253133|NCT01169532|"     This phase I trial is studying the side effects and best dose of giving ridaforolimus and     vorinostat together in treating patients with advanced solid tumors or lymphoma. Giving     ridaforolimus in combination with vorinostat may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth.   "
253137|NCT01169584|"     This is a Phase I, open-label, dose-escalation trial of JX-594 (Pexa-Vec) in pediatric     patients with advanced/metastatic, unresectable solid tumors refractory to standard therapy     and/or the patient does not tolerate standard therapies. Tumors are likely to include     neuroblastoma, lymphoma, Wilms' tumor, rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma,     non-rhabdomyosarcoma soft tissue sarcomas, and malignant peripheral nerve sheath tumors.     Benign tumors are excluded. These tumor types were selected because evidence of biological     activity was observed in cancer cells lines and ex vivo infected primary human tissue     samples, specifically pediatric cancer types such as sarcomas and neuroblastomas.   "
253138|NCT01169597|"     Polymyalgia rheumatica (PMR) is a common inflammatory condition affecting elderly people and     involving the girdles. The mainstay of treatment is oral glucocorticoids (GC), with the     recent BSR-BHPR guidelines suggesting an initial prednisone dose comprised between 15 and 20     mg as appropriate. However, probably because of the dramatic response of PMR to GC,     randomized controlled trials of treatment are lacking. As a result, there is no evidence from     controlled studies on the efficacy of different initial doses or drug tapering. Objective of     the study: to test if 12.5 mg prednisone/day is an adequate starting dose in polymyalgia     rheumatica (PMR) and to evaluate clinical predictors of drug response.      Methods: 60 consecutive PMR patients will be treated with a starting dose of 12,5 mg/day     prednisone. Clinical, laboratory, and ultrasonographic features will be recorded as possible     predictors of response to prednisone. Remission is defined as disappearance of at least 75%     of the signs and symptoms of PMR and normalization of ESR and CRP within the first month, a     scenario allowing steroid tapering.   "
253139|NCT01169610|"     The overall hypothesis of this line of research is that varenicline will decrease alcohol     consumption and tobacco use and will increase alcohol and tobacco abstinence rates. In order     to explore this hypothesis, the investigators will conduct a two-phase study: 1) an open     label pilot study investigating the effect of varenicline on reduction of and abstinence from     alcohol and tobacco; and 2) an optional MR spectroscopy to investigate whether glutamate and     other brain metabolites correlate to measures of alcohol craving severity and/or subsequent     varenicline treatment response.   "
253140|NCT01169623|"     Hypothesis Applying Educational Intervention Based On Supportive behaviour Leadership Model     has positive effect on Head Nurses' performance in TUMS Hospitals.      Specific objectives        1. Assessing the impact of supportive leadership behaviour on individual head nurse        2. Assessing the impact of supportive leadership behaviour on nursing team        3. Assessing the impact of supportive leadership behaviour on TUMS organizational success,          especially in cross-functional environments        4. Develop a specific plan for effectively supportive leadership behaviour the efforts of          others to sustain and encourage productive performance and employee satisfaction   "
253178|NCT01170130|"     The purpose of this study is to determine if the mydriatic effect of intracameral lidocaine     1% is as effective as topical cyclopentolate 1% and phenylephrine 10% for achieving effective     mydriasis during phacoemulsification surgery.   "
253141|NCT01169636|"     Objectives:      Primary objective:        -  Phase-I: To determine the maximal tolerated dose (MTD) of panobinostat (LBH589) +          Ifosfamide + Mesna, Carboplatin and Etoposide (ICE) combination        -  Randomized Phase-II: To estimate the complete response (CR) rate in patients with          relapsed and refractory classical Hodgkins Lymphoma (HL) receiving ICE versus          PANOBINOSTAT plus ICE therapy      Secondary Objectives:        -  To assess the safety and tolerability of the novel combination of PANOBINOSTAT (LBH589)          plus ICE versus ICE in patients with relapsed and refractory HL        -  To estimate the overall response rate (CR + partial response PR)        -  To estimate the success rate of stem cell collection in patients eligible for stem cell          transplant        -  To estimate the percentage of patients who subsequently undergo autologous stem cell          transplantation (ASCT)        -  To estimate the event free survival (EFS) at 1 year after randomization        -  To determine pretreatment expression level of histone deacetylases (HDAC1), HDAC2, and          pSTAT3 and Signal transducer and activator of transcription protein (pSTAT6) by          Immunohistochemistry (IHC) and correlate the results with treatment response   "
253142|NCT01169649|"     The purpose of this study is to test a new drug called MK-2206. This study is a phase II     study. In cancer studies, a phase II study is to find out what effects, good and/or bad, a     new treatment has against a certain type of cancer.      MK-2206 is an oral medication known as a targeted therapy. By attaching to the target, we     hope that MK-2206 may stop the cancer cells from further growth and dividing. This study will     help find out if MK-2206 is a helpful drug when taken in patients with neuroendocrine tumor.   "
253143|NCT01169662|"     Nitrate provides the body with an alternative source of Nitric Oxide which plays a large role     in promoting blood flow and reducing blood pressure. Nitrate supplementation with     vegetable/fruit juice has recently been shown to reduce blood pressure and reduce energy     expenditure during low intensity exercise. Such findings combined with the previously known     biological effects of nitric oxide would suggest that nitrate supplementation would also     impact on blood flow. The aim of this study is to examine the effects of dietary nitrate     supplementation via vegetable/fruit juice drink on cerebral (brain) blood flow (using Near     Infrared Spectroscopy).   "
253144|NCT01169675|"     This Phase I study will investigate the safety of BIBW 2992 in combination with standard dose     pemetrexed (500mg/m2) given on a 21 day cycle in patients with advanced solid cancers. BIBW     2992 will be given on two different dose schedules; dosing on days 1-21 and dosing on days 1     to 6 of a 21 day cycle.      The use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), including     BIBW 2992 have demonstrated efficacy in solid tumors including non-small cell lung cancer     (NSCLC). In addition, pemetrexed has demonstrated efficacy and has been approved as single     agent chemotherapy in second-line NSCLC patients with adenocarcinoma. The data obtained from     this trial shall allow for a conclusion as to whether BIBW 2992 may be safely administered in     advanced cancer patients in combination therapy with pemetrexed.   "
253145|NCT01169688|"     This study was done to compare efficacy, safety and efficiencies of various methods of pupil     dilation prior to cataract surgery.   "
253146|NCT01169701|"     The objective of the study is to compare the cardiovascular profile of an everolimus and     mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic     acid regimen in maintenance renal transplant patients   "
253151|NCT01169779|"     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010) in     comparison to placebo, as an add-on treatment to metformin with or without sulfonylurea, over     a period of 24 weeks of treatment.      The primary objective is to assess the effects on glycemic control of lixisenatide (AVE0010)     in comparison to placebo as an add-on treatment to metformin with or without sulfonylurea in     terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.      The secondary objectives are to assess the effects of lixisenatide over 24 weeks on     percentage of patients reaching HbA1c less than (< ) 7 percent (%) or HbA1c less than or     equal to (<=) 6.5%, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG)     and glucose excursion during standardized meal test, body weight; to evaluate safety,     tolerability, pharmacokinetic (PK) and anti-lixisenatide antibody development.   "
253152|NCT01169792|"     The genetic polymorphisms of the cytochrome P450 may influence on the metabolism of     tamoxifen.      The investigators want to        -  evaluate the frequency or incidence of the genetic polymorphisms of cytochrome P450          subfamilies(CYP2D6, CYP3A4/5 and CYP2C19) in breast cancer patients, and        -  analyze the association between the genetic polymorphisms of cytochrome P450 subfamilies          and clinical outcomes in breast cancer patients treated by adjuvant tamoxifen therapy.   "
253153|NCT01169805|"     The aim of this prospective randomized controlled study was to compare the prophylactic     effects of intravenous single dose of ondansetron, ramosetron, and palonosetron on     PCA-related nausea and vomiting after urologic laparoscopic surgery.   "
253154|NCT01169818|"     Primary Objective:      To compare patient-led titration (intervention group) versus physician-led titration (usual     standard of care) in optimizing the clinical use of insulin glargine in an Asian population     of patients with Type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs     (OADs).      Secondary Objectives:      To determine the difference in glycemic control, safety, quality of life and treatment     satisfaction between patient-led titration and usual care.   "
253179|NCT01170143|"     To compare the efficacy in terms of the pathological complete response rate (pCR) to     preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH)   "
253155|NCT01169831|"     Endothelial Progenitor Cells (EPCs) are circulating cells released from bone marrow which are     important for maintaining cardiovascular health. The prevalence of cardiovascular disease in     older adults is associated with reduced circulating EPC numbers. Studies have shown reduced     EPC number and function in old vs. young individuals, and endurance exercise training     increases EPC number and function in young adults. Oxidative stress adversely affects     endothelial cells and preliminary evidence indicates that oxidative stress negatively affects     EPC function. Conversely, regular exercise reduces markers of oxidative stress and may     enhance EPC function in older adults. The investigators hypothesize that older     endurance-trained athletes and matched sedentary individuals will have markedly divergent EPC     function and that altering the physical activity levels of both groups will move them to     intermediate points between these two extremes. The investigators also propose that the     investigators can mimic the effect of exercise training on EPC function in cell culture by     altering intracellular levels of a key enzyme and a signaling molecule which the     investigators have shown to regulate EPC function with respect to exercise training in young     individuals.   "
253156|NCT01169844|"     This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in     patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for     patients in the core trial, to obtain safety and tolerability information. The study will     address the evaluation of efficacy following doses of 3 mg/kg AIN457 given every 4 weeks over     a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in     psoriatic arthritis a decision will be made as to whether or not to continue dosing for     another 6 month period (Part 2).   "
253157|NCT01169857|"     The primary objective is to test the safety and efficacy of Velcade to induce remission in     WHO class III/IV/V lupus nephritis that are refractory to standard medications.   "
253158|NCT01169870|"     The purpose of this study is to evaluate the overall response rate of Genexol-PM compared     with paclitaxel (cremophor-based paclitaxel) as palliative chemotherapy in     anthracycline-pretreated patients with metastatic breast cancer.   "
253159|NCT01169883|"     Inner-city African American and Hispanic adolescents suffer from disproportionately high     rates of emergency room visits and hospitalizations for acute exacerbations of asthma. This     study proposes the use of a coping peer support intervention, enhanced by a technology-based     platform that infuses peer support throughout adolescents' daily routines, to increase     adherence to daily controller medications and ultimately reduce asthma exacerbation risk in     this important population subgroup.   "
253160|NCT01169896|"     Observational study is evaluating Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF)     thérapies as a function of ventricular pacing   "
253161|NCT01169909|"     Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in     pterygium, a neovascular disorder of the ocular surface.   "
253162|NCT01169922|"     This research is examining how genetic and brain factors play a role in adolescents' health     risk behavior as well as studying behaviors that young people engage in that may place them     at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of     educational program works best to reduce these risky behaviors.   "
253163|NCT01169935|"     Treatment of a wide range of diseases using stem cells and other types of cell appears     promising. Following administration of cells it is often not clear where exactly the cells     have gone and how many of them have reached the target site. This has been one of the     challenges of developing these treatment options further. We have developed a method of     labelling human cells with a magnetic resonance imaging (MRI) contrast agent which contains     tiny iron filings. Following intravenous administration it is possible to see where the     iron-labelled cells have gone using MRI scanning. We would like to do is to demonstrate that     these cells behave normally and migrate to a site of inflammation. We plan to induce an area     of inflammation in the forearm of healthy volunteers using the Mantoux test (a test of     immunity against tuberculosis) before giving the labelled cells intravenously. After the     Mantoux test we will give these volunteers iron-labelled cells and do MRI scans of their     forearm to determine whether these cells can be seen accumulating in the target site.   "
253165|NCT01169961|"     The purpose of the present study is to evaluate in hemodialysis patients, who have elevated     serum ferritin ( >2000ng/ml) and transferrin saturation (TSAT) >30%, iron deposition in the     heart, pancreas, liver and spleen using the T2* MRI technique.      In addition, we will also measure the free iron forms in the plasma and LPI, LCI in red blood     cells, platelets and PMN, in addition to serum hepcidin, TSAT, serum ferritin, CRP and     oxidative stress parameters (ROS,GSH, and malonyldialdehyde (MDA).   "
253166|NCT01169974|"     The investigators aim to test the hypothesis that Laser speckle contrast imaging allows for     the measurement of cutaneous blood flow following various durations of tourniquet ischemia.   "
253167|NCT01169987|"     This observational study will document to what extent in daily clinical practice Humira     (adalimumab) therapy is continued, interrupted or permanently discontinued during a follow-up     period of 2 years. Reasons for interrupting or permanently discontinuing Humira therapy and     reasons for restarting Humira therapy will be noted. An evaluation will be performed of the     effect of the disease on quality of life and work productivity.   "
253233|NCT01164566|"     Brief Summary:      RATIONALE: Comparing results of diagnostic procedures, such as esophagoscopy, done before and     after radiation therapy and/or chemotherapy may help doctors predict a patient's response to     treatment and help plan the best treatment.      PURPOSE: This clinical trial is studying esophagoscopy in evaluating treatment in patients     with stage I-IV head and neck cancer who are undergoing radiation therapy and/or     chemotherapy.   "
253442|NCT01173133|"     The purpose of the study is to understand the relevance of tissue oximetry measures of tissue     flaps during surgery and during recovery, and to determine if T-Stat is a reliable and early     method of detecting compromised flaps.   "
253168|NCT01170000|"     A national priority for health care providers is to initiate early communication about     palliative and end-of-life care (PC/EOL) for children with a poor prognosis. Communication     about prognosis and advanced care planning is critical to empowering parents to make     decisions about PC/EOL for their children. A single-group study to refine and pilot test a     PC/EOL communication intervention is entitled, Communication Plan: Early through End of Life     (COMPLETE). COMPLETE is designed to be delivered during parent meetings and features: (a) a     physician-nurse (MD/RN) team approach to PC/EOL communication; (b) printed visual aids and     parent resource forms; and (c) hope and non-abandonment messages tailored by a MD/RN team to     their communication style and parental preferences for information. During Phase I, an     interdisciplinary approach involving nurses, physicians, PC/EOL expert consultants, and     bereaved-parent consultants met to develop a standardized protocol and training procedures.     During Phase II, this protocol will be evaluated with 24 parents and MD/RN teams. The     investigators will evaluate parental outcomes regarding the COMPLETE's influence on: (a)     information needs, emotional needs/resources, appraisal of MD/RN information and of symptom     management; and (b) parental distress, uncertainty, decision regret, hope, satisfaction with     MD/RN communication, and advance care planning over time. Findings from this study address     NIH priorities related to: 1) an underserved population (i.e., parents of children with brain     tumors); 2) an under-examined ethical concern about early integration of PC/EOL communication     for parents of children with poor prognosis; 3) improved communication about PC/EOL among     physicians, nurses, and parents; and 4) the potential for changing health care practice.   "
253169|NCT01170013|"     The earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of     long-range problems. This association persists despite changes in national substance use     rates over time, indicating its stability and viability as a target for prevention. At the     same time, parent monitoring of youth behavior tends to decrease during the adolescent years,     creating a source of risk for not only the early onset of AOD use but also escalation. Thus,     programs are needed in parenting behaviors and family relationships that are protective in     helping pre-adolescent youth to avoid initiation of AOD use and abuse. This is particularly     true of children with psychiatric disorders who are at higher risk for developing AOD     disorders than nonpsychiatrically disturbed children. The primary goal of this study is to     test the effectiveness of a family-centered intervention to reduce the risk of AOD use among     pre-adolescent children with a history of emotional/behavioral problems. In this application,     the families of 80 youths aged 12-14 years, who have not yet begun AOD use but have been     referred for mental health care due to psychiatric symptomatology, will be randomly assigned     to receive either an individually tailored family program or standard care. The experimental     intervention, which is based on the Family Check-Up model (Dishion & Kavanagh, 2003),     provides a thorough assessment of family strengths and weaknesses as they relate to future     risk for AOD use as well as emotional/behavioral problems, and utilizes principles of     motivational interviewing to encourage families to change. Follow-up interviews will be     conducted at 6 and 12 months after baseline to assess changes in parenting, AOD use, and     other risky behaviors.   "
253170|NCT01170026|"     This application will provide a test of one potential model for adding substance use     assessment and brief intervention into a truancy court program. The primary goal of this     study is to determine whether a motivational intervention will reduce substance use among     adolescents referred to truancy court for school attendance problems. In this treatment     development application, an open trial with 20 families referred by truancy court will first     be conducted. This trial will be used to adapt an existing motivational intervention to     include material relevant to school attendance and performance. Then 100 families     participating in the Rhode Island Truancy Court Program with adolescents between the ages of     13-16 years who report using substances will be randomly assigned to receive the experimental     intervention plus standard truancy court procedures or psychoeducation plus standard truancy     court procedures. The 2-session intervention protocol consists of an individual motivational     interview plus the Family Check-Up (Dishion & Kavanagh, 2003), a family based motivational     interview. The experimental protocol provides a thorough assessment of both individual and     family strengths and weaknesses with respect to substance use prevention and school     attendance/performance. Follow-up interviews will be conducted at 3 and 6 months.   "
253195|NCT01164059|"     This study is designed to compare the efficacy and drug tolerability of two strategies for     the treatment of schizophrenia. The two strategies consist of utilizing, on the one hand, a     conventional antipsychotic like haloperidol or flupentixol and, on the other hand, a newer     antipsychotic compound like olanzapine, quetiapine or aripiprazole in patients with     schizophrenia.   "
253171|NCT01170039|"     The investigators will recruit a total of 136 diabetic men and women with constipation into     this study from both The Emory Clinic and The Atlanta Veteran's Administration Hospital. The     investigators will track spontaneous bowel movements defined as a bowel movement in 24 hours     after initiation of study drug (SBMs) in all patients two weeks before treatment with     lubiprostone as well as measure baseline colonic transit using the Smartpill pH capsule.     Colon transit reflects that rate of colonic peristalsis and movement of stool through the     large bowel.      Patients will receive either lubiprostone 24 micrograms (mcg) orally twice a day for 8 weeks     or placebo. Primary and secondary endpoints will be the number of SBMs/week and colonic     transit time as measured by the Smartpill capsule, respectively. The number of SBMs/week will     be evaluated at 0, 2, 4 and 8 weeks after initiation of therapy. The investigators will     over-sample African American patients to achieve approximately 50% enrollment of this group.     In a subanalysis, the investigators will assess response to treatment between the general     population and African Americans.      We hypothesize that lubiprostone will significantly increase the number of SBMs as well as     decrease colonic transit time and improve quality of life in constipated diabetic patients     compared with placebo.   "
253172|NCT01170052|"     The purpose of this study is to assess the safety, tolerability and activity of the     combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell     lymphoma who are not eligible for high dose chemotherapy and autologous/allogeneic stem cell     transplantation.   "
253173|NCT01170065|"     The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with     Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.      The primary objective will be to establish the long term tolerability and safety profile of     BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).      As a secondary objective the effects of long term treatment with BIBF 1120 on survival as     well as safety and efficacy parameters will be investigated in an open-label, not randomized,     un-controlled design.   "
253180|NCT01170156|"     The leakage of oropharyngeal secretions around high-volume low-pressure tracheal tube cuffs     is usually considered as a major risk factor for bacterial tracheal colonization and     subsequent development of ventilator-associated pneumonia. The rate of leakage around the     cuff is related to the pressure differential across the cuff, namely the difference between     the pressure of the subglottic fluid above the cuff and the tracheal pressure under the cuff.     Consequently, positive end-expiratory pressure (PEEP) improves the sealing around the cuff     towards fluid leakage. However, this preventive effect of PEEP is compromised during     prolonged mechanical ventilation by tracheal suctioning manoeuvre, which may enhance fluid     leakage, by decreasing tracheal pressure. Indeed, in a benchtop model, a suctioning     manoeuvre, without disconnection of the ventilator, induced a constant fluid leakage past a     high-volume low-pressure tracheal tube cuff when performed with a high level of suction     pressure (- 400 mbar) and a large size of suction catheter size (16 French).   "
253181|NCT01170169|"     This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules     under fasting condition.   "
253182|NCT01170182|"     This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules     under fed condition.   "
253183|NCT01170195|"     The purpose of the proposed study is to test the effect of Licorice Root Extract- Licogen on     postmenopausal symptoms in postmenopausal women. Specifically, the study will also test the     effect of the licorice extract on vaginal dryness.   "
253184|NCT01170208|"     The purpose of the study is to determine the effectiveness and safety of the computer     software program in providing insulin dosage recommendations. Participation in the study for     60 research subjects will last for 16-weeks and includes 3-4 clinic visits and a series of     weekly telephone calls from the study team (minimum of 12 calls). Participants will be     provided with weekly Study Log Sheets to record their daily blood glucose readings, insulin     doses, grams of carbohydrate eaten at each meal (if they have type-1 diabetes) and any     changes in their health (e.g., hypoglycemic episodes, illnesses). Participants will fax or     drop off a copy of the Study Log Sheet. This information will be entered by the IDC study     team into the computer software program. The IDC study team will review the information from     the software and, based on the IDC's study team approval, any insulin dose changes will be     communicated back to the patient by phone or fax.   "
253185|NCT01170221|"     This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA     200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days     for the treatment of ABSSSI in adults.      Approximately 75 to 100 sites globally will participate in this study. Patients with an     ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be     randomized 1:1 to study treatment   "
253186|NCT01170234|"     There is currently no reliable, noninvasive biomarker for eosinophilic esophagitis (EoE), a     chronic allergic diseases characterized by significant infiltration of eosinophils in the     esophagus. Because eosinophils release nitric oxide, levels of exhaled nitric oxide (FeNO)     are used routinely for guiding treatment in subsets of patients with asthma. FeNO levels are     also elevated in immunological diseases that do not involve the airways. The investigators     hypothesize that patients with EoE have elevated nitric oxide concentration in their exhaled     breath and that changes in FeNO levels could be used to measure disease activity. The     objective of this study is to determine the feasibility of using FeNO as a noninvasive     surrogate marker for EoE disease activity. The investigators propose to measure serial     exhaled nitric oxide (FeNO) levels on a group of patients with confirmed EoE, before, during     and after the course of topical corticosteroid therapy to determine whether the level     declines from pre-treatment level in individual patients.   "
253187|NCT01170247|"     The purpose of this study is to determine if intranasal ketamine is equally as effective and     safe as intramuscular ketamine for procedural sedation in pediatric patients.   "
253188|NCT01170260|"     This research is studying behaviors that young people engage in that may place them at risk     for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational     program works best to reduce these risky behaviors.   "
253226|NCT01164462|"     Objective: This research agreement brings together French and Canadian teams of scientists,     HIV testing centers and community based partners. The aim is to explore the feasibility and     limitations of offering community based rapid HIV testing to men who have sex with men (MSM).   "
253189|NCT01170273|"     Vitamin D insufficiency is a problem of growing concern, given its prevalence in older     persons and the association of low vitamin D with multiple major health problems, including     mobility and balance deterioration and falls, cardiovascular disease, diabetes, and certain     cancers. Sedentary persons are particularly vulnerable for these health problems and     generally not adherent to prescribed physical activity. This study will investigate if     treatment with vitamin D will benefit physical performance in male veterans age 65 to 95.   "
253190|NCT01170286|"     The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated     epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device)     in peanut allergic subjects.   "
253191|NCT01170299|"     RATIONALE: Fiber may lessen bowel side effects caused by radiation therapy. It is not yet     known whether a high-fiber diet is more effective than a low-fiber diet in preventing bowel     side effects caused by radiation therapy.      PURPOSE: This randomized clinical trial is studying a high-fiber diet to see how well it     works compared with a low-fiber diet in preventing bowel side effects in patients undergoing     radiation therapy for gynecological cancer, bladder cancer, colorectal cancer, or anal     cancer.   "
253199|NCT01164111|"     Purpose:      The purpose of this study is to determine the effect of pre operative resistance training on     subjects scheduled for total hip arthroplasty due to primary osteoarthritis.      Background:      Decreasing performance with age due to age related muscle loss is well known. Resistance     training in elderly has shown significant effect in regaining both muscle force and function.      It has been shown that a chronic condition with limitations in function as seen in     osteoarthritis of the hip decreases both muscle performance and size.      Studies of resistance training of the hip related muscle groups in the early postoperative     period after total hip arthroplasty have shown significant effect on muscle force and     function.      Few studies have investigated preoperative intervention, all with lighter types of training     such as water pool training.      The effect of preoperative resistance training on subjects with primal osteoarthritis of the     hip is yet to be described.      Study hypothesis:      Preoperative resistance training will significant improve outcomes on both primal and     secondary effect parameters pre surgery and at 1 year followup.   "
253192|NCT01170312|"     Rotator cuff tears are a common injury that lead to pain and loss of function for those who     suffer from it. Treatment includes the use of arthroscopic surgery to return function to the     patient and reduce their pain. This study is interested in a technique that has the potential     to improve patient outcomes in terms of less pain and better function after their surgery.     Autologous Conditioned Plasma (ACP) or Platelet Rich Plasma (PRP) is the intervention of     interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a     high concentration of cells called platelets. Platelets release growth factors important for     healing, as well as fibrin, which acts like a biological glue. The PRP is then re-injected     into the shoulder at the time of surgery and again at 4 weeks. It has been shown to     accelerate healing in other studies for injuries such as chronic elbow tendinopathy, but     there is no randomized controlled trial that evaluates the effect of PRP in rotator cuff     tears. It is on this basis that the study is being performed. Participating patients will     receive either a PRP injection or a placebo (normal saline) and the effects will be compared     at 2 weeks, 4 weeks, and 6 weeks based on a pain score and return to function questionnaires.     The primary hypothesis for this study is that ACP compared with placebo is effective in     reducing pain at the site of a rotator cuff injury that has undergone arthroscopic repair. It     is expected that ACP administered during surgery and 4 weeks post-surgery will reduce 6-week     pain scores compared to the placebo group.   "
253193|NCT01170325|"     Background:        -  Electroencephalography (EEG) records electric patterns produced by the brain, and can          detect conditions such as epilepsy or other l abnormalities that may affect brain          function. In EEG studies, electric patterns that resemble epileptic seizures are known          as epileptiform pattern. These patterns are associated with an increased risk of          seizures, even in people who have not been diagnosed with epilepsy. Epileptiform          patterns also appear on the EEGs of some children who have autism spectrum disorders but          do not have epilepsy. It is unclear if these discharges are related in any way to the          symptoms of autism (behavior, language or intellectual abilities).        -  Divalproex sodium (Depakote) is a drug that has been used for many years to treat          epilepsy and other brain disorders in children and adults. Researchers are interested          determining whether treatment with divalproex sodium can reduce epileptiform patterns in          children with autism spectrum disorders, and in doing so study whether this treatment          can improve behavior, language or cognition in children with autism spectrum disorders.      Objectives:      - To study the effectiveness of using divalproex sodium to reduce epileptiform EEG discharges     in children with autism spectrum disorders.      Eligibility:      - Children between 3 and 10 years of age who have an autism spectrum disorder and show     frequent epileptiform discharges on an overnight EEG.      Design:        -  This study will last for a total of 9 months, with 6 months of treatment with either          divalproex sodium or a placebo followed by 3 months of treatment with divalproex sodium          only.        -  Potential participants will be screened with a physical examination and medical history,          blood samples, and psychological tests, and will spend the night in the NIH Clinical          Center to have an overnight EEG. Children with frequent epileptiform abnormalities on          the EEG will continue with the study; all others will be considered ineligible.        -  Eligible participants will receive either divalproex sodium or a placebo to be taken          twice daily for 24 weeks. Neither the investigators nor the participants will know which          they are taking.        -  Participants will have regular visits (every 2-4 weeks) to monitor for adverse effects          and to test for possible behavioral improvement, and will also have overnight EEG          testing at 12 and 24 weeks.        -  At the end of the 24-week study period, participants will have the option to have an          additional 12 weeks of treatment with divalproex sodium.        -  A final evaluation (including EEG) will be conducted at the end of the final treatment          period.   "
253194|NCT01164046|"     Background      Patients with cancer and a first deep venous thrombosis of the leg or pulmonary embolism     (venous thromboembolism, VTE) are generally treated with low molecular weight heparin     (LMWH)injections for 6 months, since this treatment is associated with a reduced incidence of     recurrent VTE compared to vitamin K antagonists (VKA). It is recommended that patients with     active malignancy (metastatic cancer and/or ongoing cancer treatment)continue anticoagulant     treatment. However, it is unknown whether LMWH is still superior compared to VKA for the     long-term anticoagulant treatment.      Aim      The aim of this study is to evaluate whether low-molecular-weight heparin more effectively     reduces recurrent VTE compared to vitamin K antagonists in patients with cancer who have     already completed 6 to 12 months of anticoagulant treatment because of deep venous thrombosis     of the leg or pulmonary embolism.      Hypothesis      The investigators hypothesize that LMWH is more effective compared to VKA in the long-term     treatment of VTE in cancer patients who have already been treated for 6-12 months with     anticoagulants.      Design      This is a multicenter, multinational, randomized, open label trial.      Patients      Patients with a malignancy (all types, solid and hematological) who have received 6-12 months     of anticoagulation for VTE and have an indication for continuing anticoagulation, will be     randomly assigned to six additional months of LMWH or VKA. LMWH will be administered in a     weight-adjusted scheme, with 65-75% of therapeutic doses. All types of LMWH and VKA are     allowed, as long as weight adjusted dosing is possible for LMWH. The target INR will be     2.0-3.0. The primary efficacy outcome is symptomatic recurrent VTE, i.e. deep vein thrombosis     and pulmonary embolism. The primary safety outcome is major bleeding.      Sample size      A total of 65 to 87 recurrent VTE events are needed to show a 50% reduction with LMWH as     compared to VKA (type I error 0.05, two-sided, power respectively 80 and 90%). To observe 75     events, with a 10% event rate per half year in the VKA arm and 5% in the LMWH arm a total of     1000 patients will need to be included.      Organisation      Outcomes will be adjudicated by a central adjudication committee. A steering committee will     be formed, preferably consisting of one member of every participating center. An electronic     case report form will be used for data collection. Also, an electronic trial master file will     be used.   "
253227|NCT01164475|"     The purpose of this study was to compare the responses of 2 different doses of plerixafor in     patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.   "
253196|NCT01164072|"     The study's major aim is to investigate the ability of a commercial Electronic Nicotine     Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers     unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and     cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe.      The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms,     and adverse events of a currently marketed device in Italy (Categoria electronic cigarette     - ORIGINAL 7.2 mg nicotine cartridges).      The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction     or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.   "
253197|NCT01164085|"     Intraocular delivery of ketorolac will be an effective means to treat inflammation and     macular edema and prevent structural complications and vision loss in patients with uveitis     who are unable to tolerate corticosteroids due to their side effects.   "
253198|NCT01164098|"     The investigators propose to study novel targets of rituximab in podocytes, with a particular     focus on recurrent focal segmental glomerulosclerosis (FSGS). The proposed study has strong     clinical implications, since it may extend the approved indications for rituximab treatment     to recurrent FSGS as well as to other proteinuric diseases. Furthermore, it will offer new     insights into the role of sphyngomyelin related enzymes in podocyte function in health and     disease, thus allowing the identification of novel targets for antiproteinuric drug     development. Finally, the proposed study offers the opportunity to identify a correlation     between the patient's specific clinical outcome and the experimental results obtained after     exposing podocytes to patient sera in the presence or absence of rituximab. Therefore, it may     lead to the development of an assay for the pre-transplant identification of patients at     high-risk for recurrent disease and, among them, may allow the identification of those     patients that will respond to rituximab.   "
253202|NCT01164150|"     Post-operative radiotherapy is internationally accepted as standard practice in the     management of high-risk endometrial cancer1. Whilst it has no proven impact on overall     survival it significantly increases local control.      Conventional radiotherapy techniques (3-dimensional) utilise a 3 or 4 field beam arrangement     to target the pelvis in order to treat those areas at risk of recurrence: the vagina, the     parametrium and the pelvic lymph nodes. However, when using such a technique it is not     possible to avoid irradiating sensitive normal tissues such as the bowel and bladder.      Toxicity data from international randomised control trials in endometrial cancer report     significantly more haematological, gastrointestinal, genitourinary and cutaneous toxicites     (all grades) in those who received pelvic irradiation compared to those who did not2,3. These     trials delivered radiotherapy using 2 or 3-dimensional techniques.      Intensity Modulated Radiation Therapy (IMRT) is a newer but established radiotherapy     technique in many tumour sites that allows us to much more tightly conform the radiation. It     uses computer-generated beams to produce radiotherapy volumes that can avoid irradiation of     normal tissues in the pelvis.      There are no randomised studies reported in the literature that compare 3-dimensional pelvic     irradiation with IMRT in patients who have had surgery for endometrial cancer. However there     are several small studies that report considerable sparing of normal tissues using IMRT and     when compared retrospectively with conventionally treated patients demonstrate marked     reductions in acute gastrointestinal and genitourinary toxicity4.      By delivering post-operative radiotherapy to the pelvis using IMRT (as opposed to the     standard 3-dimensional technique) it is anticipated that whilst local control and survival     will be unaffected acute and late toxicity will be reduced.   "
253203|NCT01164163|"     RATIONALE: INCB18424 (Ruxolitinib) may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth.      PURPOSE: This phase 1 clinical trial is studying the side effects and best dose of INCB18424     in treating young patients with relapsed or refractory solid tumor, leukemia, or     myeloproliferative disease.   "
253204|NCT01164176|"     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with     locally advanced or metastatic thyroid cancer.   "
253205|NCT01164189|"     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill     them or carry tumor-killing substances to them. It is not yet known whether temozolomide is     more effective when given with or without bevacizumab in treating patients with recurrent     glioma.      PURPOSE: This randomized clinical trial is studying how well temozolomide works with or     without bevacizumab in treating patients with recurrent glioma.   "
253206|NCT01164202|"     RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and     keeping anticancer drugs near the tumor. Sunitinib malate may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth and by blocking blood flow to the     tumor. It is not yet known whether chemoembolization is more effective with or without     sunitinib malate in treating patients with liver cancer.      PURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization     of the liver and to see how well in works when given together with or without sunitinib     malate in treating patients with liver cancer.   "
253207|NCT01164215|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin     calcium, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy,     may kill more tumor cells. Studying samples of blood in the laboratory from patients with     cancer receiving fluorouracil in combination with oxaliplatin and leucovorin calcium may help     doctors learn how fluorouracil works in the body and how patients will respond to treatment.      PURPOSE: This phase I trial is studying biomarker-guided fluorouracil in treating patients     with colorectal cancer receiving combination chemotherapy.   "
253208|NCT01164228|"     RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet     known whether giving sunitinib malate and gemcitabine hydrochloride together is more     effective than sunitinib malate alone in treating patients with kidney cancer.      PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together     with or without gemcitabine hydrochloride to see how well they work in treating patients with     advanced kidney cancer that cannot be removed by surgery.   "
253294|NCT01171196|"     The purpose of this study is to validate the Berlin questionnaire and STOP-BANG (snore,     tired, obstruction, pressure, body mass index (BMI), age, neck, gender) as effective     screening tools for Chinese subjects who are suspected to have obstructive sleep apnea (OSA).   "
253209|NCT01164241|"     Background:      - Allergic inflammation is central to allergy-related diseases and disorders, such as asthma,     food allergies, and atopic dermatitis. Atopic dermatitis, commonly called eczema is a     chronic, noncontagious skin condition, usually starting in the first years of life, which     causes itching and scaling of an individual s skin. Because atopic dermatitis is a common     condition in children who have allergy-related diseases, including asthma, researchers are     interested in studying both individuals with atopic dermatitis and their close relatives     (parents and children) to better understand how allergy-related diseases develop and     progress. In addition, some patients with inherited disorders with features including atopic     dermatitis or other aspects of allergy such as food allergy, asthma, hay fever, hives, and     others, will also be seen.      Objectives:      - To study the natural history of diseases of allergic inflammation, such as atopic     dermatitis or genetic disorders associated with allergic inflammation.      Eligibility:        -  Children and adolescents between 1 month and 21 years of age who have a documented          history of moderate to severe atopic dermatitis.        -  Individuals between 1 month and 80 years of age who have a suspected genetic or          inherited allergy disorder related to atopic dermatitis or allergic pathways.        -  Child and adult relatives of eligible participants will also be studied on this          protocol.      Design:        -  The study will require one initial visit to the National Institutes of Health Clinical          Center (lasting 1-5 days), as well as any required follow-up visits for treatment and          research studies. Participants will receive treatment for atopic dermatitis and other          allergic diseases as part of the study for up to 1 year.        -  Participants will have some or all of the following tests as part of this study:        -  A detailed physical examination and medical history        -  Allergy skin prick testing to examine participants' responses to different allergens.        -  Blood samples for additional allergen testing, testing the immune system, and other          research purposes        -  Skin punch biopsy to take a skin sample        -  Lung function tests to measure airflow from the lungs and inflammation        -  Food-related tests to diagnose potential food allergies        -  Leukapheresis to collect white blood cells only        -  Research samples, including stool specimens, saliva samples, buccal swabs (to collect          cells from the inside of the cheek), and skin cell samples        -  Clinical digital photography to provide images of affected and healthy skin.        -  Participants will be asked to return for follow-up visits and tests for up to 1 year          after the initial visit(s).   "
253210|NCT01164254|"     In spite of long-standing hypothesis relating diet and physical activity to several cancers,     diet and physical activity-cancer associations have been modest at best and often     inconsistent in epidemiologic studies. Investigators around the world have become     increasingly concerned that error in the measurement of both diet and physical activity is     compromising our ability to detect these important but modest associations. Most commonly     used diet and physical activity assessment methods have been based on a relatively small set     of questions (e.g. 124 food items consumed or 5-10 physical activities in the past 12     months). Recent developments in computer technology provide an opportunity to use     internet-based instruments to assess an individual s diet and physical activity more     accurately and cost effectively.   "
253211|NCT01164267|"     This is a multicenter open-label uncontrolled phase II study. There are no previous clinical     data to estimate the expected response rate of everolimus in MALT lymphomas and in the other     less common MZLs (i.e. nodal and splenic) refractory or relapsing after at least 1 prior     systemic treatment (chemotherapy or immunotherapy).      The primary objective of this study is to define the antitumor activity, in term of overall     response rate (ORR), as sum of complete remissions (CR) and partial remissions (PR) of     everolimus in relapsed or refractory marginal zone B-cell lymphomas.      The secondary objectives of this study are to assess safety, as acute or long-term toxicity,     response duration (RD) (time to relapse or progression) in responders and progression-free     survival (PFS) (time to disease progression or death from any cause) in all patients.   "
253212|NCT01164280|"     Objectives: To evaluate the effect of pulse rate changes on the clinical response and     stimulation related pain symptoms in sacral neuromodulation (SNM) treatment.      Materials and Methods: This pilot study evaluated the effect of 4 different pulse rates     (5.2Hz-10Hz-21Hz-40Hz) in patients with suboptimal response to SNM. The effect of each     frequency was evaluated over test period of 6 days. To avoid carry over effect, stimulation     was kept off for 24 hours between consecutive test periods. The last 3 days of every test     period, a voiding diary (VD) and questionnaire was filled in. The changes on clinical     response and pain symptoms were compared between the four pulse-rates using multivariate     analysis.      Results: Fifty patients were included of which 40 (80%) were female. Mean age was 55.5yr (SD     12.3). Forty-one patients (82%) had overactive bladder symptoms and 9 (18%) had chronic     non-obstructive urinary retention. No significant difference was found regarding clinical     outcome (VD and questionnaire) between the different pulse rates. Furthermore, none of the     four pulse rates was significantly related to the occurrence of SNM-related pain. However, on     individual basis, patients appear to benefit from changing the pulse rate concerning both     treatment efficacy and stimulation related pain.      Conclusions: On group level, none of the four pulse rates in this study appears to have a     significantly different effect on clinical outcome or SNM-related pain. However, a     tailor-made approach for optimizing treatment efficacy by changing the pulse rate might be     useful.   "
253213|NCT01164293|"     Positive reactions in Atopy patch test in children with food allergy-related gastrointestinal     symptoms   "
253214|NCT01164306|"     The purpose of this randomized control trial is to evaluate the effects of a multi-component     intervention aimed at:        1. preventing tobacco initiation in youth        2. promoting anti-tobacco socialization in the home        3. decreasing environmental tobacco smoke exposure in children        4. promoting successful cessation in parent/guardian smokers.      Control arm participants receive general health education. This family-based approach is     implemented with school systems as the primary point of entry.   "
253215|NCT01164319|"     The aim of this study is to identify the most appropriate method for managing patients with     AF recurrences after the first ablation procedure, through the diagnostic data stored by a     subcutaneous AF monitor.   "
253216|NCT01164332|"     The disposition of NRL972 after a 15-second intravenous injection of 2 mg NRL972 is     distinctly slower in patients with hepatic cirrhosis and acute hepatitis than in healthy     control subjects. NRL972 appears to be a suitable investigational marker of hepatic     transporter clearance dysfunction.      Although the pharmacokinetics of NRL972 provide a reliable differentiation between subject     groups, this approach relies on precisely timed sampling of venous blood, cautious     preparation, handling and on-site storage of plasma samples, the transfer of samples to a     central laboratory for analysis, and the availability of a validated assay procedure.      For these reasons, there is interest in developing and validating alternative methods for     determining the concentration of NRL972 in venous blood. Two such methods have been developed     to date, but their utility in determining NRL972 pharmacokinetics has yet to be established.   "
253217|NCT01164345|"     The aim of this study is to evaluate Plerixafor (MOZOBIL) plus recombinant human G-CSF     (G-CSF) efficiency in mobilizing sufficient number of stem cells from Lymphoma (NHL and HL)     patients for autologous transplantation.   "
253295|NCT01171209|"     The purpose of the study is to determine if Interferon-alfa is effective and safe in multiple     sclerosis patients who developed neutralizing antibodies for Interferon-beta.   "
253218|NCT01164358|"     This study is a prospective, open, not randomized, unilateral multicenter eye study     consisting of two study arms to observe the long term satisfaction of patients after an     INTRACOR treatment. The satisfaction is determined with the help of the patient perception     and the subjective / objective diagnostic data.      The hypothesis of the study is that patients after an INTRACOR treatment are satisfied in the     long term.   "
253219|NCT01164371|"     The initial manifestation of symptomatic coronary disease can range from angina (or symptoms     of angina), unheralded acute coronary syndrome (ACS), or unheralded coronary death. A better     understanding of gender differences in initial presentation of coronary disease and the rate     and predictors of progression to subsequent stages in coronary disease could help to identify     which gender- specific factors might reduce or slow transition to more serious disease states     and improve outcomes. The investigators' research focuses on the role primary care management     of cardiovascular risk factors plays in gender differences in the progression to subsequent     disease states and to mortality.   "
253220|NCT01164384|"     Erstes Safety Trial mit Baminercept in chronischen HCV Patienten. Untersuchung des potentiell     antiviralen, antiinflammatorischen Effekts sowie Modulation der hepatischen Gen-Expression.      10 Patienten, open label, 10 Wochen Therapie. Sequentielles Enrollement der ersten 4     Patienten.        -  Trial with medicinal product   "
253221|NCT01164397|"     The aim of this study is to evaluate the effectiveness of Rosuvastatin versus     Ezetimibe/Simvastatin in dyslipidemic patients treated for at least 8 weeks.   "
253232|NCT01164553|"     The purpose of this study is to evaluate the possibility that giving an increased dose of flu     vaccine to children 6 through 35 months of age will improve protection against influenza     without increasing side effects. Investigators will evaluate the body's response to the     vaccine. Male and female participants' ages 6-35 months, who have never received flu vaccine,     and those ages 12-35 months, who have been previously vaccinated, will participate in the     study for about 7 months. Vaccine naïve study participants will receive two doses of flu     vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Previously vaccinated     subjects will receive one dose of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL     dose (Group 2). Study procedures include physical examination, memory aids, blood sampling     and a follow-up phone call about 6 months after the last vaccine dose.   "
253222|NCT01164410|"     Bowel preparation solutions containing Polyethylene Glycol is a commonly used preparation of     the colon for colonoscopy in children. However young children and adolescents often subject     to the volume and taste of liquid that must be consumed for an adequate preparation.     Currently almost all of our patients experience some difficulty with completing the colyte     preparation and approximately 10-20% is unable to achieve adequate cleansing due to inability     to drink the solution. The standard colyte solution is salty and often impedes children from     drinking the required amount of colyte preparation for adequate colon cleansing. Miralax has     been used at a dose of 1.5gm/kg/day to a maximum of 102 gms /day as four day prep Four day     bowel prep can be extremely frustrating for the parents and the patients. This may result in     low patient acceptance, limiting compliance leading to inadequate colonoscopy. Decreasing the     duration of the prep may increase the compliance and provide better colon visualization.      Hence a Cross sectional study looking at the safety,efficacy,tolerability of PEG 3350 mixed     in Gatorade G(TM) as a bowel prep in children needs to be conducted. Consent will be obtained     from parents and assent will be obtained from patients. Previous laboratory tests for each     patient will be reviewed. All patients in the study will be required to consume     MiralaxTM/Gatorade GTM the day prior to their procedure. The patients will be given written     instructions as to how to much solution to take and how to prepare and consume the solution.     The patient shall be maintained on a clear liquid diet the day prior to the procedure. Once     patients arrive for the colonoscopy they will be asked to complete a questionnaire regarding     their bowel preparation. Prior to the administration of IV fluids, 1ml of blood will be     obtained a basic metabolic panel. The patient will then undergo a colonoscopy by routine     procedure and technique. The endoscopist will complete a questionnaire when done with the     colonoscopy to rate the cleanliness of the colon.      We propose that MiralaxTM combined with Gatorade GTM given the day prior to colonoscopy is a     safe, tolerable and efficacious cleansing regimen for colonoscopy in children.   "
253223|NCT01164423|"     Hyperglycemia is common in critically ill patients and associated with an adverse outcome.     Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of     the intensive care unit staff difficulties were experienced in achieving efficient and safe     glucose control. A fully automated algorithm may help to overcome some of these limitations     by excluding intuitive interventions and integrating relevant clinical data in the     decision-making process. Space GlucoseControl (TGC system) is a decision support system which     helps to achieve safe and reliable blood glucose control in the desired ranges. Information     on parenteral and enteral nutrition is automatically integrated into the calculations. The     primary objective of the current study is to investigate the performance and usability of the     Space TGC system for glucose control in medical ICU patients.   "
253224|NCT01164436|"     The incidence of lymphomas is increased among HIV infected patients. In 70 % of cases, those     are Non Hodgkin's lymphomas (NHL) and Hodgkin lymphomas (HL) in 30% of cases. In France,     their incidence is estimated to 100 cases per year (data from the Base de données     Hospitalière Française sur l'Infection à VIH (FHDH)). The main mechanisms involved in     lymphomagenesis are immune dysfunction, involvement of oncogenic viruses (Epstein-Barr (EBV)     and HHV8) and molecular oncogenic events. A better understanding of these different pathways,     give the possibility to design specific treatments. The treatment of these lymphomas is not     standardized. A prospective study of patients with HIV associated lymphoid malignancies is an     innovating tool to answer epidemiological, physiopathological and therapeutic questions. We     propose a prospective multicentric study of these patients.      The main objectives of this prospective study are to:        -  evaluate the incidence, characterise clinically and histologically NHL and HL cases          associated to HIV        -  perform an observational study of the treatment and outcome of these patients out of the          context of clinical trials,        -  study the differentiation and activation of B-cell populations,        -  better understand the role of specific T cell responses in the control of EBV infection,        -  allow other biological studies from the ANRS group  Lymphome et VIH .      The recruitment of 40 cases per year is expected. The length of inclusions is 7 years. The     follow-up will be of 2 years. Clinical, pathological and biological data at diagnosis and     during follow-up will be collected. This will allow characterizing the lymphoma, the HIV     infection, the antitumoral treatments and the outcome of lymphoma. Biological samples will be     centralized to collect cell, DNA, RNA, plasma, serum and tumour collections (Y.Taoufik, S     Prevot* ). To better understand the EBV infection and lymphomagenesis in HIV infection, we     propose to follow the viral load and the molecular characteristics of EBV in PBMC, plasma and     tumour (P.Morand* , V.Boyer* ), to investigate the EBV-T cell responses (G.Carcelain) and the     presence and reactivation of EBV in peripheral B cells (C.Amiel* , JC Nicolas) and in tumoral     samples (M.Raphael* , I.Joab* ). The other mechanisms of lymphomagenesis in HIV infection     will be studied by the analysis of the sub-populations of B-cells in terms of activation and     differentiation (Y.Taoufik) and by the characterization of MSI tumours (A.Duval).   "
253225|NCT01164449|"     Hyperglycemia is common in critically ill patients and associated with an adverse outcome.     Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of     the intensive care unit staff difficulties were experienced in achieving efficient and safe     glucose control. A fully automated algorithm may help to overcome some of these limitations     by excluding intuitive interventions and integrating relevant clinical data in the     decision-making process. Space GlucoseControl (TGC system) is a decision support system which     helps to achieve safe and reliable blood glucose control in the desired ranges. Information     on parenteral and enteral nutrition is automatically integrated into the calculations. The     primary objective of the current study is to investigate the performance and usability of the     Space TGC system for glucose control in medical ICU patients.   "
253228|NCT01164488|"     This non-randomized, open-label study will evaluate the interaction of     RO5190591(danoprevir)/ritonavir with and without ketoconazole and the safety and tolerability     in healthy volunteers. Participants will be administered repeated daily doses of ketoconazole     alone, RO5190591/ritonavir, and RO5190591/ritonavir plus ketoconazole. The anticipated time     on study treatment is 25 days.   "
253229|NCT01164501|"     This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic     patients with renal impairment in order to provide these data for approval for BI 10773 as an     antidiabetic agent by regulatory authorities.   "
253230|NCT01164514|"     The purpose of this study is to test the safety of an experimental vaccine against sepsis     (infection of the blood) alone and with an experimental adjuvant (a substance that may     improve vaccine effectiveness). This study will also find out how well antibodies are made     after receiving vaccine alone or vaccine combined with adjuvant. Participants will include up     to 34 healthy volunteers between the ages 18-50 years. Participants will be randomly assigned     to 1 of 4 groups to receive vaccine alone, vaccine with adjuvant (2 different dosages) or     placebo (inactive substance). Participants will receive 3 vaccinations at different times     during the study (Day 0, Day 29 and Day 59). Study procedures will include blood samples,     urine samples, electrocardiogram (measures heart activity) and a completion of a memory aid     to document side effects. Participation will involve 16 clinic visits and 3 follow-up     telephone calls over 12 months.   "
253231|NCT01164540|"     This study evaluates whether treatment with rosuvastatin on top of standard anti-coagulant     treatment will decrease the risk of recurrent venous thromboembolism and arterial     thromboembolic events in patients with previous deep vein thrombosis or pulmonary embolism.   "
253234|NCT01164579|"     Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early     rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate     naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by     magnetic resonance imaging, x-rays and by standard clinical assessment.   "
253235|NCT01164592|"     The purpose of this study is to assess changes in left ventricular performance using     echocardiography as well as ventricular remodelling, changes in sleep and changes in mood,     anxiety and cognitive functions occurring as a result of treatment of predominant central     sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to     optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF     study.   "
253236|NCT01170338|"     Assess the role of a nicotine antagonist in helping patients presenting to hospital with     acute coronary syndrome to stop smoking.   "
253237|NCT01170351|"     Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are     corticosteroids (CS). In addition to being ineffective a substantial minority of cases,     corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options     for induction of remission are limited. There are reports of successful salvage therapy with     Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have     shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies     comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy     and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH     patients.   "
253238|NCT01170364|"     Obesity is a major public health concern, and the search for useful pharmacologic     interventions is ongoing. This study aims to develop a comprehensive series of assessments to     directly assess eating behavior, cognitive functioning, and psychological functioning under     sibutramine and placebo conditions.   "
253239|NCT01170377|"     The aim of this study is to evaluate the effect of valproate on the required dose of propofol     for sedation in patients with mental retardation.   "
253240|NCT01170390|"     The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral     contraceptive metabolism in a manner which results in decreased effectiveness in obese women.   "
253241|NCT01170403|"     64 channel multidetector-row Computed Tomography (CT) has been introduced for use in the     diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery     disease in type 2 diabetes mellitus and metabolic syndrome, and in particular plaque natures     depending on different status of metabolic diseases. The investigators also aimed to analyze     the risk factors associated with number and severity of stenosis as well as plaque     characteristics using logistic regression models.   "
253242|NCT01170416|"     Patients sometimes suffer from life-threatening abnormal heart racing that originates from     the lower chamber of the heart. These patients will often need an implantable defibrillator     which has the ability to shock the heart back to a normal heart rhythm, but this does not     prevent them from getting frequent recurrences of the bad heart rhythm needing shocks from     the device. This can be painful and potentially harmful. Medicines to prevent recurrences of     shocks are not very effective and have many side effects. An alternative to medicines for     this is a procedure called a catheter ablation in which a wire is passed up through the blood     vessels of the leg into the heart and used to find the short circuits which cause the     dangerous heart rhythm. When the spot causing the trouble is found, the investigators can     burn it (ablate it). This procedure is challenging and methods are needed to make it more     effective and easier to do. One of the main ways for finding the short circuits involves     using the electrocardiogram (the ECG). The regular ECG is simplistic and only makes use of     recordings from 10 sites (6 precordial sites and 4 sites on both upper and lower limbs) on     the body surface. The investigators are testing whether making recordings from 120 sites on     the chest and back and using special computerized analysis of the recordings can help make     catheter ablation for dangerous heart rhythms more effective.   "
253243|NCT01170429|"     The purpose of this study is to investigate the efficacy and safety of procaterol     hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma     (CVA).   "
253244|NCT01170442|"     Vitamin D status has been negatively associated with the presence of type II DM and glycemic     control. However, a cause-effect relationship between vitamin D deficiency and glycemic     control has not been established. The investigators plan to conduct a double blind,     randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic     control in Type II DM.   "
253245|NCT01170455|"     The purpose of this study is to determine whether nasal tracheal intubation using Blind     Intubation Device is safe and effective in anesthetized patients with Mallampati class 3   "
253246|NCT01170468|"     Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status     has been negatively associated with the presence of type II DM and glycemic control. A     cause-effect relationship between vitamin D deficiency and the development of type II DM has     not been established.      The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled     trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk     individuals.   "
253247|NCT01170481|"     Assessment of optic disc morphology can be difficult in patients with uveitis and     papilloedema. Therefore different optical coherence tomography (OCT) and laser scanning     techniques may help to detect damage to the retinal nerve fibre layer.   "
253248|NCT01170494|"     Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of     vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or     large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2     compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining     total 25 OH vitamin D level.      The investigators plan to conduct a controlled trial to compare the effect of various vitamin     D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level     between 20 to 50 nmol/L.   "
253266|NCT01170806|"     Obesity is a chronic condition with fat-rich diets playing a major role in its etiology.     Pharmacological therapy has been proposed for weight loss and maintenance. This study aims to     study the intestinal lipase blockade by partial inhibition of fat absorption after treatment     with two commercials formulations of Orlistat.   "
253249|NCT01170507|"     Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of     vitamin D status. The determination of the appropriate dose of vitamin D supplement is     essential for management of vitamin D deficiency as well as for designing vitamin D     fortification programs. The increments in 25 OH vitamin D levels following various doses of     vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level     have not been well defined. The time course of depletion of repleted vitamin D stores is also     not known.      The investigators plan to conduct a double blind randomized study on 9 cohorts to determine     levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5     months and their withdrawal for 3 months.   "
253250|NCT01170520|"     The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and     effective add-on therapy for resistent depression in adolescent patients.      A group of adolescents suffering from non psychotic major depression that was resistant to at     least 2 drug trials and a trail of psychotherapy will be recruited. After an informed consent     procedure for both parents and patients, patients will go through a clinical and cognitive     evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using the figure     of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain interval of 30     sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.   "
253251|NCT01170533|"     Clopidogrel, in combination with aspirin, is currently the recommended treatment for     secondary prevention of ischemic events in high-risk patients and for prevention of coronary     artery stent thrombosis. Patients receiving aspirin and clopidogrel are frequently treated     with proton pump inhibitors, such as omeprazole or pantoprazole, in order to prevent the risk     of gastrointestinal bleeding, accorded to guidelines. An interaction between proton pump     inhibitors and clopidogrel has been suggested, which may lead to a decrease of clopidogrel     effects. It remains unclear whether this interaction between PPIs and clopidogrel might be a     class effect or if this may be affected by timing regimen.      The objectives of this two-phase investigation are:        1. to compare clopidogrel platelet inhibitory effects when taken at the same time versus          separated at least 8 hours from omeprazole administration.        2. to compare clopidogrel-induced inhibitory effects when taken at the same time versus          staggered at least 8 hours from pantoprazole administration.   "
253252|NCT01170546|"     Question: To investigate how different modes of thigh muscles strengthening exercises     emphasizing the knee internal rotators can be as effective as possible in improving the     static stability and agility of the knees with anterior drawer laxity.      Design: Randomized controlled clinical trial.      Participants and Interventions:      Young men with anterior drawer laxity of the knee were randomly assigned to three     experimental groups in different strengthening modes: plate-loaded squat press (SP),     plate-loaded kneeling leg curl with internal rotation (KLCIR), and kneeling leg curl (KLC).     The control group with stable knees received no training.      Outcome measures: static and dynamic knee stability, isokinetic strength. The purpose of this     paper was to find out an optimal solution to the enhancement of the static and dynamic knee     stability to a great extent.      Key words: anterior cruciate ligament; agility; knee stability; hamstring; knee internal     rotator   "
253253|NCT01170559|"     Heart rhythm abnormalities underlie one of the common presenting complaints to the A&E and     out-patient departments, specifically awareness of heart beats or palpitations. Unless an ECG     (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is having     symptoms, it is very difficult to determine the cause of the palpitations. The conventional     approach is to refer these patients from the emergency departments to the Cardiology     outpatients where they undergo repeated short term rhythm monitoring hoping to record the     rhythm underlying the patient's complaint. Unfortunately, this often yields no results thus     delaying definitive treatment and incurring extra costs of repeated investigations and A&E     presentations. This study aims to compare the ability of the conventional approach to     establish a definite diagnosis compared to that of an early invasive monitoring approach with     a small implantable device that records the heart rhythm at all time for up to 18 months.   "
253277|NCT01170949|"     Randomised, double-blind, placebo-controlled study evaluating the effects of miltefosine on     skin lesions in patients with treatment resistant chronic urticaria. Treatment resistance is     defined by insufficient treatment response after a minimum of 1 week therapy with the maximum     labelled dose of a non-sedating antihistamine. Eligible subjects will be enrolled at baseline     8 (+/- 1) days after screening. 75 Patients will be randomised in a 2:1 ratio to one of the     following treatment groups as add-on to the ongoing therapy with a non-sedating antihistamine     for treatment period of 4 weeks: 25 placebo and 50 active drug Efficacy and safety     evaluations are done at baseline day 7, 14, 21 safety, only) and 28 (or end of treatment) and     at day 56 (28 days after end of treatment).   "
253254|NCT01170572|"     Studies in chickens show that blood levels of a particular form of vitamin D (called     24,25-dihydroxvitamin D) increase after bone fracture. Laboratory studies show that this form     of vitamin D helps the bone healing process in chickens. The investigators want to find out     whether blood levels of this form of vitamin D increase after bone fracture in humans.     Previous research studies have not addressed this question. The results of this research     could eventually lead to the development of new treatments to help bone healing after     fracture.      Patients will be asked to take part in this study if they are aged 16 years or older and come     to the Royal London Hospital with a broken bone in the arm or leg or collar bone (clavicle).     They will be asked to give a 20ml (about 4 teaspoons) blood sample on three occasions: at the     start of the study, at 5-14 days after the fracture; and at 4-10 weeks after the fracture.     The rest of their normal care would not be affected. Follow-up blood samples will be timed to     coincide with routine clinic visits which are scheduled as part of normal clinical care.     Patients' vitamin D level will be measured as part of the study, and those who have a low     vitamin D level will be informed about this, and advised about appropriate vitamin D     supplementation. The investigators will let the patient or their GP know if any blood tests     are abnormal   "
253267|NCT01170819|"     To compare the efficacy of transcervical double balloon catheters versus controlled release     dinoprostone vaginal inserts for pre-induction cervical ripening in term women with     unfavourable cervices.   "
253268|NCT01170832|"     This proposal will test if, in patients with type 1 diabetes, wide blood glucose fluctuations     lead to the injury to heart nerves , called cardiac autonomic neuropathy (CAN), and to     impaired heart contractile (pumping) function and heart failure. It will also evaluate the     natural history of heart failure and enhanced cardiac risk in patients with type 1 diabetes     in the current standard of diabetes care.   "
253269|NCT01170845|"     A neutrophil elastase inhibitor may have effect on suppression of the lung injury after     thoransthoracic esophagectomy. The investigators hypothesized that postoperative     complication, particularly respiratory complication may be reduced by neutrophil elastase     inhibitor after esophagectomy.   "
253270|NCT01170858|"     Peritoneal dialysis (PD) is an established dialysis modality in patients with end stage renal     disease (ESRD). However, there is growing awareness of the deleterious effect of high glucose     content in PD solutions on the peritoneal membrane over time (1). Accordingly, development of     new solutions to minimize glucose-induced toxicity and/or containing an alternative osmotic     agent to glucose such as icodextrin and amino-acid were developed. Icodextrin is a mixture of     high molecular weight, water soluble glucose polymers isolated by fractionation of hydrolyzed     cornstarch (2). Unlike glucose which is absorbed from the peritoneal cavity primarily by     diffusion across the peritoneal capillary endothelium, its absorption occurs mainly due to     convective fluid movement out of the peritoneal cavity via the lymphatics (2). As a result,     relatively constant osmotic pressure is created by icodextrin, thus it can provide sustained     ultrafiltration during the long dwell.      A number of studies have reported that icodextrin-based solution provides various clinical     benefits compared with conventional glucose-based solutions (3-7). In particular, icodextrin     has been successfully used in the fluid management of PD patients (4-5, 7). However,     excessive ultrafiltration may induce underhydration, resulting in faster decline in residual     renal function. This concern was first raised by Konings et al (8). In this study, a greater     fall in residual glomerular filtration rate (GFR) was observed in patients using icodextrin     compared to those using 1.36% glucose solution. In contrast, contradictory findings were also     reported from the two studies indicating that residual renal function can be preserved by     icodextrin solution (4, 9). Although the mechanisms are not clear, possible explanation     includes the presence of high-molecular-weight icodextrin metabolites in plasma, which in     turn may increase plasma oncotic pressure and hence preserve plasma volume and renal     perfusion as suggested by Davies et al (10). Such discrepant findings may be explained by     differences in study design, baseline fluid status, and other factors affecting residual     renal function during the study. In the study by Konings et al (8), the comparative solution     was 1.36% glucose, whereas 2.27% glucose was used in the study by Davies et al (4).     Therefore, it can be speculated that volume status might differ depending on different     concentration of glucose solution, thus leading to conflicting results. Also, these two prior     studies are limited by residual renal function as secondary outcome, a short follow-up     duration (4 mo vs. 6 mo), and small number of patients (32 vs. 50).      To further explore the effects of icodextrin solution on residual renal function, the     investigators will conduct a multicenter prospective randomized controlled open-label trial.     Briefly, incident or prevalent adult CAPD patients with residual urine volume > 750 ml will     be included. Patients on APD will be excluded. After a 4-week screening period, patients will     be randomly assigned to icodextrin or 2.5% glucose solution for the long dwell. Residual GFR     and fluid status will be assessed at baseline, 6, and 12 months. Residual GFR will be     calculated as an average of urea and creatinine clearance from a 24-hour urine collection. To     assess fluid status, the investigators will use three different assessment tools; 1)     echocardiography for measuring intra vena cava (IVC) diameter and left ventricular end     diastolic diameter, 2) measurement of plasma atrial natriuretic peptide, 3) bioimpedence     analysis. Primary outcome is residual GFR change at 1-year and secondary outcome is change of     fluid status during the study period. Also, biochemical laboratory data such as hemoglobin,     hsCRP, plasma osmolality, and lipid profile, peritoneal equilibration test, dialysis     adequacy, and daily peritoneal glucose exposure will be monitored. At least 50 subjects (a     total of 100) would be required for each group to detect 50% difference of residual GFR     between the two groups if type I error rate is 5% and type II error is 20% given 30% of     drop-out rate during the study period.      Preservation of residual renal function is of paramount importance because it is an     independent risk factor of mortality in PD patients. In addition, achievement of adequate     ultrafiltration is another crucial therapeutic goal to improve clinical outcomes in these     patients. In this regard, if these two goals can be accomplished by icodextrin, it would be     an ideal dialysis solution in PD practice. The investigators study will address this issue to     answer the unresolved question on the effect of icodextrin on residual renal function.   "
253255|NCT01170585|"     Systemic Lupus Erythematosus (SLE) is a condition that affects the whole body. It can cause     inflammation of the blood vessels resulting in an earlier thickening and hardening of the     arteries resulting in strokes. It has been reported that SLE can worsen the function     resulting in heart failure.      The aim of the study is to examine what effects Rosuvastatin, a cholesterol lowering drug,     given to patients has on the degree of thickening of the arteries over the course of two     years. We also want to see how it affects the function of the blood vessels and also of the     heart.      Individuals who agree to participate will be randomly assigned into two groups. One group     will be given the active drug whereas the other will have a placebo. Subjects in the study     will all have a cardiac magnetic resonance (CMR) scan before treatment, at 1 year and then 2     years at the end of the treatment. Each scan will involve imaging the carotid arteries in the     neck, the arteries in the arm and also the heart. Individuals will continue to have regular     out-patient reviews by their own team of doctors, regular blood tests will be taken to     monitor the disease and also to ensure the safety and well being of the individual.      At the end of the 2 year study we hope that we will be able to slow down the rate of arterial     thickening and retard any plaque build up in the arteries. We also want to see what effect     rosuvastatin has on heart function. Ultimately, we hope to prove that people with SLE should     be treated with a cholesterol lowering drug as part of their routine treatment.   "
253256|NCT01170598|"     Fatigue, reduced quality of life and declines in physical function are common in patients     undergoing chemotherapy for acute myeloid leukaemia (AML). Studies in other cancer patients     undergoing treatment have shown that exercise improves these symptoms, but there are limited     studies in AML. This study of a hospital-based exercise program will help determine if     exercise is both feasible and helpful in improving symptoms among for AML patients undergoing     chemotherapy.   "
253257|NCT01170611|"     This clinical investigation is a prospective, single-blinded, randomized trial. The primary     objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive     algorithms.   "
253258|NCT01170624|"     The purpose of this study is to evaluate the performance of advanced features, that have been     implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual     Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities     (PARADYM CRT System, model 8750) in a general ICD population.   "
253259|NCT01170637|"     The objective of the current study is to demonstrate bioequivalence of a fixed dose     combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg (Test) and     RhinAdvil® (Reference) a fixed dose combination tablet containing ibuprofen 200 mg and     pseudoephedrine-HCl 30 mg following orally administration.   "
253260|NCT01170650|"     The purpose of this study is to compare progression-free survival (PFS) (based upon     investigator assessment using RECIST v1.1) in participants with platinum-resistant ovarian     cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin     (EC145+PLD) with that in participants who receive PLD and placebo.   "
253261|NCT01170663|"     This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating     the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared     to paclitaxel plus placebo.   "
253278|NCT01170962|"     The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a     and ribavirin can result in higher cure rates in patients who previously failed therapy and     may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.   "
253279|NCT01170975|"     This study explores the effects of food (a high-fat meal) on the pharmacokinetics of     tesetaxel.   "
253280|NCT01170988|"     Is the surgical treatment of patients with coronary heart disease using the T-graft technique     an adequate solution that provides a sufficient myocardial flow reserve? A magnetic resonance     examination (MRI) is required.   "
253281|NCT01171014|"     The purpose of this study was to investigate the dose response effect of Bifidobacterium     lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.   "
253262|NCT01170754|"     A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for     colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets     Phosphosoda) are now used on a limited basis because of their known association with renal     injury. Polyethylene glycol (PEG) mixed with a balanced electrolyte solution (e.g. Golytely)     has been used for over two decades for colon cleansing. The mixture is not very palatable due     to the electrolyte additives which include sodium sulfate.      To overcome the limitation of existing preps, gastroenterologists and colorectal surgeons     worldwide have been using PEG powder alone (same quantity as found in Golytely prep) not     mixed with electrolytes (Glycolax or Miralax) and dissolving this into 64 ounces of Gatorade.     Conservatively, we estimate that 25% of colonoscopies in the US are being done with this     prep. Anecdotally there have been reports (case series) that it is far more palatable and the     prep is equally efficacious. The active ingredient, PEG, is not changed and therefore this is     not surprising. The issue at present is that there has never been a blinded study to confirm     these claims.      This study will compare the efficacy of the two preps. There is no funding. The investigators     will charge insurance companies for the prep - this is our current practice. The procedures     will be done on healthy individuals referred for colon cancer screening and the exam will be     billed to their insurance. There will be no patient honorarium. The investigators will check     electrolytes to be sure patients do not develop hypokalemia with the Gatorade prep.   "
253263|NCT01170767|"     Age Related Macular Degeneration (AMD) is the first cause of visual impairment in elderly     patients in industrialized countries. Neovascular or wet AMD, characterized by the presence     of choroïdal neovessels, represents the most aggressive form of the disease. Its prevalence     is 3.3% among patients older than 65 years in Europe, and increases with age.      Intraocular injections of anti-angiogenic monoclonal antibodies (ranibizumab) to treat AMD     have appeared recently. It is derived from a larger sized molecule, bevacizumab, which do not     have the market authorization for this indication. However, numerous publications of case     series seem to show the effectiveness and a satisfactory safety profile of bevacizumab.      These conclusions have to be confirmed with a high level of evidence study. The aim of the     GEFAL study is to demonstrate non-inferiority of effectiveness in clinical terms after 12     months of treatment with bevacizumab compared to ranibizumab on the visual acuity of patients     affected by neovascular AMD.   "
253264|NCT01170780|"     Does corticosteroid (dexamethasone) have an effect on the postoperative period after     laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and     convalescence. This randomized, double-blinded study compares dexamethasone versus placebo.     The patients are recommended one day of convalescence. The medicine or placebo is given     before operation. The patients fill out questionnaire before operation and three hours after     operation and in the following three days. The patients also register when they return to     normal activities and work.   "
253265|NCT01170793|"     In patients with MOH, we will evaluate the impact of educative telephone coaching on the     number of days with headache over the month preceding the appointment. The educative coaching     will be administered by a nurse, during a single phone call and prior to the medical visit   "
253271|NCT01170871|"     The purpose of the study is to determine the maximal tolerated dose (MTD) of Ixabepilone and     Pemetrexed in advanced solid tumors and to obtain preliminary information regarding the     activity of this combination.      This research study is for research participants who have confirmed metastatic or     unresectable solid tumors (lung, breast, ovary, cervix, uterus, mesothelioma, and prostate)     for which standard curative or palliative measures do not exist or no longer effective.   "
253272|NCT01170884|"     Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or     Ocular Hypertension Subjects Treated with Xalatan®.   "
253273|NCT01170897|"     This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic     and pharmacodynamic study in patients with advanced solid tumors.   "
253274|NCT01170910|"     Our hypothesis is that the Waters Medical® pulsatile perfusion machine (RM 3) is a way to     improve delayed graft function (DGF) in marginal grafts, and some perfusion profiles (flow,     pressure, resistance index, venous effluent pH) are correlated with better recovery of renal     function (without dialysis during the first week after transplant).      Observation or Investigation Method Used :      The study is multicenter, prospective, open, controlled and randomized:grafts are divided     into two parallel groups:        -  group 1 corresponds to a conservation of grafts in static incubation        -  group 2 corresponds to conservation using a pulsatile perfusion machine      Duration and Organizational Arrangements for Research :      The total duration of the study is planned for 36 months. This duration includes:        -  an inclusion period that will last 24 months,        -  the follow-up of recipient patients from the day of transplantation until twelve months          after the operation   "
253275|NCT01170923|"     The usual response to chemotherapy is decided through the image change by computed tomography     (CT), which is taken at least 6-9 weeks.      In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at     the first cycle of chemotherapy. Chemotherapy was guided by the metabolic response by FDG-PET     scan.   "
253276|NCT01170936|"     This is a single-center open label study to assess the efficacy and safety of single doses of     canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that neutralizes IL-1β,     in patients with active urticarial vasculitis. Efficacy is primarily assessed by a combined     symptom score, the urticarial vasculitis activity score (UVAS). Following a baseline period     of 2 weeks, patients will be dosed with two single s.c. injections of 150 mg (consistent with     a total dose of 300 mg canakinumab). Visits for investigator's assessments will be scheduled     at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks post dose. Patient's     self-assessment will be performed on a daily basis throughout the study. Overall a max. of 10     subjects with urticarial vasculitis will be enrolled.   "
253282|NCT01171027|"     This study is designed to be a United States multicenter prospective randomized controlled     non-inferiority evaluation of transgastric and transvaginal Natural Orifice Translumenal     Endoscopic Surgery (NOTES) cholecystectomy compared to laparoscopic cholecystectomy in     elective surgery patients. Up to 200 patients will be enrolled to obtain 70 NOTES     cholecystectomies (35 transgastric and 35 transvaginal) and 70 laparoscopic cholecystectomies     on a randomized basis. In order to evaluate the hypothesis that NOTES cholecystectomy has     equivalent safety and efficacy to laparoscopic cholecystectomy, clinical and administrative     outcomes will be measured.   "
253283|NCT01171040|"     Left ventricular filling pressure (LVFP) has prognostic significance in patients with heart     failure. Traditionally, it should be assessed by invasive method, as cardiac catheterization     and Swan-Gung catheter. In advance of new techniques and modality, echocardiography provides     some useful parameters for assessing LVFP, such myocardial tissue Doppler imaging. Many     articles had documented that peak velocity of early-diastolic trans-mitral inflow velocity     divided by early-diastolic velocity over mitral annulus correlated closely to LVFP. However,     myocardial tissue Doppler only provides the information of regional myocardium, so patients     with regional wall motion abnormality, as coronary artery disease, can't be assessed by this     method without handicap. In addition, conduction disturbance, like bundle branch block, also     influences the result of myocardial tissue Doppler. For resolving those problems, the     investigators had designed a new global parameter to assess LVFP. In the investigators prior     study, left atrial distensibility correlated logarithmically to LVFP in patients with severe     mitral regurgitation and also in patients with acute myocardial infarction. Left atrial     distensibility provided a new viewpoint to assess left ventricular diastolic function and to     predict prognosis. This time, to extend left atrial distensibility to general population     received echocardiographic examination for predicting prognosis is attempted.   "
253493|NCT01173367|"     The impact of fever and its management in different medical and surgical populations of     critically ill patients has not been explained to date. The current study aims to assess the     safety and efficacy of treatment of critically ill patients with a permissive versus     aggressive fever treatment strategy.   "
253284|NCT01171053|"     The aim of this study is to investigate the efficacy of a 10 week Internet-delivered CBT     treatment for patients diagnosed with IBS. The patients' work with the treatment and is     supported through online contact with a therapist.      Approximately 86 patients will be included in the study and randomized to either condition.      All included patients are assessed one week before the treatment starts. After 10 weeks (post     treatment). Follow-up assessments are conducted at 3 and 12 months follow-up after treatment.      Patients in treatment condition are hypothesized to experience significant reduction IBS     symptoms, societal costs and quality of life compared to patients on waiting list.   "
253285|NCT01171079|"     The purpose of this study is to evaluate the effects and safety of oxidized, regenerated     cellulose as an absorbable adhesion barrier after thyroidectomy.   "
253286|NCT01171092|"     The purpose of this study is to determine if the combination of G-CSF and bortezomib is safe     and effective in blood cell mobilization.   "
253287|NCT01171105|"     1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after          multiple oral doses.        2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how          the study drug enters and leaves your body and how your body acts on the study drug) of          AZD5213 in your blood and urine.   "
253288|NCT01171118|"     The investigators are attempting to demonstrate a decrease in the frequency and severity of     sedation-induced respiratory arrhythmias(central and obstructive apneas) with pharmacological     pre-treatment in this pilot project and then eventually to understand the mechanisms behind     this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep     in Obstructed Sleep Apnea (OSA) patients, have not been systematically studied during     sedation in either normal subjects or OSA patients. The agent to be assessed in this study in     physostigmine versus placebo.   "
253289|NCT01171131|"     The aim of this research is to determine if the biological fluids (blood/saliva) from chronic     brain-injured patients (both blast and non-penetrating TBI) contain reproducible protein     markers. To accomplish this two populations of chronic TBI patients who are receiving     treatment at The Institute for Research and Rehabilitation (TIRR): blast injury victims and     non-penetrating TBI will be studied. Using multiple proteomic approaches including mass     spectrometry, multiplex ELISAs, and antibody microarrays, as well as RNA profiling, the     investigators aim to identify biomarkers in the blood/saliva of patients suffering from     chronic TBI and to determine the similarities/differences between the blast and     non-penetrating injury groups. Identification of these biochemical changes will give insight     into the long-lasting changes associated with head injury, and may identify new targets for     treating the associated pathologies.   "
253290|NCT01171144|"     This study aims at collecting data from secondary sources to obtain baseline incidence and     monitor trends over time (1990 - 2010) of reported gastroenteritis cases, gastroenteritis     related hospital discharges and gastroenteritis related deaths in children < 5 years of age     in Panama before and after implementation of Rotarix™ universal mass vaccination.   "
253291|NCT01171157|"     The purpose of this research study is to estimate how many elderly people who have symptoms     that look like influenza (i.e. an influenza-like illness) actually have the disease and how     effective influenza vaccines are in preventing influenza in elderly people. The study will     also examine the severity of the disease (e.g. how long are people ill, were there any     complications) and how it affects everyday life (e.g. cost, medications, care by family     members).   "
253292|NCT01171170|"     This study is designed to assess the effects of adding nitroglycerin (NTG) patches, delivery     25 mg NTG per 24 h, to the standard first line treatment of metastatic non-squamous non-small     cell lung cancer (NSCLC), i.e. 4 cycles of carboplatin-paclitaxel-bevacizumab, followed by     bevacizumab alone until disease progression. Tumor hypoxia is a common phenomenon in lung     cancer; it is a known poor prognostic marker, related to treatment resistance. Pre-clinical     studies have shown that nitric oxide (NO) donating drugs may decrease hypoxia related drug     resistance. NTG is a NO donating drug. NTG increases tumor blood flow and thereby augments     antitumor drug delivery to the tumor.      A randomized phase II has shown an increase in the response rate from 42% to 72%, when NTG     patches (25 mg/day, day -2 to +3) were added to vinorelbine/cisplatin in patients with     advanced NSCLC. In addition, the time to progression increased from 185 to 327 days.      The hypothesis of the present study is that adding NTG transdermal patches to bevacizumab     containing chemotherapy improves progression free survival, response rate and overall     survival in patients with metastatic non-squamous NSCLC.   "
253293|NCT01171183|"     This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine     dependent participants.   "
256176|NCT01271998|"     The primary purpose of this study is to determine the steady-state plasma pharmacokinetics     (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar     macrophages (AM) of healthy volunteers.   "
253296|NCT01171222|"     This study shall provide missing descriptive data on health status of veteran players and     potential preventive effects of soccer at an age of 40 to 60 years. The investigation     represents a cross-sectional examination of cardiovascular parameters and metabolic stress     induced by training and competition. Additionally, orthopedic and other medical risks are to     be revealed, and options should be developed to minimize these risks, e.g. by preventive     measures included in training or rule modifications.   "
253297|NCT01171235|"     The aim of the study is to find for one or more serum or tissue markers of molecular biology     in head and neck cancer patients used for early diagnosis, predicting prognosis and being     sensitive to chemotherapy and radiotherapy   "
253298|NCT01171248|"     The aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (BP)     in patients with type 1 diabetes. The investigators wish to gain knowledge on the relation     between central and peripheral 24 hour BP and a possible association to late complications in     diabetes.   "
253299|NCT01171261|"     This is a RWJF funded study that will apply behavioral choice theory and learning theory     principles to 'map' exergames to determine how behavior change principles influence sustained     use of health games by adolescents.   "
253300|NCT01171274|"     Hatha Yoga is a traditional system of exercises, used in India for the relief of painful     condition since centuries and gaining more and more interest in Europe and the US. While     studies have demonstrated benefits of Hatha Yoga for patients with chronic low back pain, no     studies regarding chronic neck pain are available until now. The purpose of this study is to     determine if Hatha Yoga can ameliorate chronic neck pain and related restrictions.   "
253301|NCT01171287|"     Research on the implications of orthopedic injury and surgery on automobile driving ability     has been limited. Only a handful of orthopedic issues have been studied to date, especially     the safe postoperative resumption of driving. However, effects of orthopedic immobilizations     of the lower right limb on fitness to drive are largely unknown, and the physician is left     with little guidance. Only one study (Tremblay et al. 2009) have looked at the impact of     wearing such devices on braking performances. The results have shown a statistically     significant increase of braking times while wearing a removable Aircast walker and a walking     cast in healthy subjects under simulated driving conditions. Despite this, the study have not     demonstrated that driving with orthopedic immobilization is dangerous since the increase in     braking times were minimal. Limitations of this study include the important fact that driving     simulation is not real-time driving. In order to assess the validity of the driving simulator     used in this study, a similar experimental study during real-time driving was thus devised.   "
253302|NCT01171300|"     Rectal cancer is a frequent but curable malignancy in the Western world. The golden standard     in treating these patients consists of neoadjuvant chemoradiotherapy (CRT) followed by     extensive surgery regardless of tumor response. The main question is whether extensive     surgery can be avoided holding in mind that already a significant amount of patients reach a     pathological complete response after radiochemotherapy. The goal of this study is dual. First     of all, the investigators want to investigate the value of DW-MRI and 18FDG-PET in the     assessment of response after neoadjuvant CRT in 100 patients with rectal cancer, to select     those patients eligible for less invasive surgery. In the same patient group, the     investigators will examine the biomarker potential of molecular characteristics of the tumor     in blood and tissue. Using both molecular and radiological findings, the investigators want     to predict pathological response after chemoradiotherapy and to select patients who may     benefit from treatment adjustments during chemoradiotherapy.   "
253303|NCT01171313|"     The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in     comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after     administration of XP21279/Carbidopa and Sinemet and to explore exposure-response     relationships in a subset of subjects.   "
253304|NCT01171326|"     Impetigo is a common, highly infectious skin disease caused by bacterial infection and     characterized by crusting skin lesions. It is most common in children, particularly children     in unhealthy living conditions. In adults, it may follow other skin disorders. Impetigo is     caused primarily by the bacteria Streptococcus pyogenes and/or Staphylococcus aureus, which     can also be isolated from impetigo lesions.      This is a pilot phase II study to evaluate the tolerability and safety and to monitor the     clinical efficacy of Topical Minocycline Foam FXFM244 in impetigo patients.   "
253305|NCT01171339|"     Objective: To investigate whether the complex intervention will improve the appropriateness     of prescriptions in elderly multi-morbid patients with multi-medication in general practices.      Study hypothesis: The primary objective of the study is to determine whether the complex     intervention will improve the appropriateness of prescriptions compared to usual care. The     primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score     from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.   "
253306|NCT01171352|"     Currently, decisions regarding volume management for dialysis sessions in the ICU are made in     large part on the nephrologists'/intensivists' overall gestalt. This gestalt is based upon a     combination of commonly used measures of circulatory function, the physical exam, fluid     balance, estimates of dialysis dry weight, and monitoring changes in relative blood volume     status using devices such as the Crit-Line™ III, and central venous pressures. However, these     tools perform poorly in predicting the circulatory system's overall response to dialysis.     Consequently, episodes of dangerously low blood pressure are still frequently encountered.     Better techniques to predict the circulatory system's response to dialysis are much needed.     The intent of this study is to test newer metrics of circulatory system function for their     ability to predict low blood pressure episodes during dialysis. This is important because it     may enable the design of newer treatment strategies created to prevent low blood pressure     episodes during dialysis and improve patient outcomes. The investigators overall hypothesis     is that newer measures of vascular volume and dynamic indices of fluid responsiveness,     previously found to better reflect cardiac preload state than currently used parameters, will     better predict low blood pressure episodes during dialysis than current methods.   "
253307|NCT01171365|"     The purpose of this study is to determine whether an inhaled steroid with a small particle     size can be an additional treatment option in patients with refractory eosinophilic asthma.   "
253308|NCT01171378|"     The purpose of this study is to evaluate Ofatumumab in combination with CHOP     (cyclophosphamide, hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and     prednisone/prednisolone, the standard chemotherapy treatment) in induction and maintenance     treatment of Richter's Syndrome. This study aims to evaluate the overall response rate to     CHOP-O (CHOP in combination with Ofatumumab) according to the Revised Response Criteria for     Malignant Lymphoma. The hypothesis would be that treatment with CHOP-O for Richter's Syndrome     (RS), shows a difference in overall survival (more people living longer), when compared with     the standard treatment of CHOP-R (CHOP chemotherapy plus Rituximab).   "
253309|NCT01171391|"     The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of     VA106483 in female subjects.   "
253310|NCT01171404|"     The aim of this international study is to describe the short- and long-term (i.e. up to 2     years following the index event) antithrombotic management patterns (AMPs) in patients     hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction     (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the     impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life'     setting and to compare these between sites, countries and regions.   "
253311|NCT01171417|"     For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to     Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line). For     all patients, to collect and explore real-life data on the epidemiology and management of     Pseudomyxoma Peritonea (PMP) patients with HR+ advanced breast cancer (ABC) treated with     Faslodex 500 mg or exemestane.   "
253312|NCT01171430|"     The main objective of this study is to examine if absence of a satisfactory response on     DCE-WB-MRI (see MR criteria of responders section) after completion of HDT followed by     autologous stem-cell transplantation (ASCT) is an independent prognostic factor for EFS in     patients with MM, compared with established ones including beta2-microglobulin and     cytogenetic abnormalities. Secondary objectives are to examine if the microcirculation     parameters obtained from baseline DCE-WB-MRI have prognostic significance and to examine if     early DCE-WB-MRI performed after the induction HDT and before ASCT might also provide     independent prognostic information for patient outcome, which might help in patient     stratification and be integrated into the response criteria in the future.   "
253313|NCT01171443|"     Since the pathophysiology of BIPN still remains unclear, in the present study we are going to     assess the development of BIPN in newly diagnosed myeloma patients, based on clinical     neurological examination and electrophysiological study (EMG) and trying to find out if there     is any relationship between oxidative stress generation measured by serum malonyldialdehyde -     (MDA) and urinary isoprostane, and the development of BIPN, which can explain important part     of the BIPN pathophysiology and can suggest new ideas of treatment and prophylactic     strategies of peripheral neuropathy.   "
253314|NCT01171456|"     Gestational diabetes (GDM) represents a significant and growing source nationwide of     morbidity and mortality for both mothers and infants. Between 5 and 10% of pregnancies are     complicated by GDM. Infants exposed in utero to hyperglycemia from GDM have an increased risk     of neonatal complications as well as an increased prevalence of a number of chronic diseases,     including type 2 diabetes and schizophrenia. Recent research shows that treatment with     metformin begun as soon as hyperglycemia is detected in pregnancy is safe and effective.     Additional studies demonstrated that metformin is able to decrease the incidence of type 2     diabetes among individuals at risk for this disease. Based upon these findings, the     investigators propose to test the hypothesis that metformin therapy for women at risk for     gestational diabetes, started prior to conception and before the onset of hyperglycemia, both     decreases the incidence of and improves the maternal and neonatal outcomes from GDM.      The investigators intend to conduct a prospective, randomized, double-blind placebo     controlled range-finding study to measure the effects of early metabolic intervention with     metformin in women at risk for GDM before the commencement of pregnancy or prior to     completion of the first trimester. The target sample size for this pilot study is 100 women.     The effect size observed will provide preliminary data for a subsequent study which will be     sufficiently powered to detect small or moderate effects from early metabolic intervention in     women at risk for GDM.      The specific aims of the proposed research consist of the following:        1. Determine whether treating women at risk for GDM with metformin prior to conception          and/or completion of the 1st trimester decreases the incidence of GDM at 26 weeks'          gestation.        2. Evaluate the effects on maternal and fetal pregnancy outcomes of pre-conception          metabolic intervention with metformin in women at risk for GDM.        3. Use these pilot study results to:             1. identify specific demographic characteristics associated with an intervention               effect             2. calculate effect size for specific outcomes             3. provide range-finding data for a subsequent study design      Metformin therapy for women at risk for gestational diabetes, started prior to conception and     before the onset of hyperglycemia, both decreases the incidence of and improves the maternal     and neonatal outcomes from GDM.   "
253315|NCT01171469|"     This is a single center Phase I study to determine the safety and maximum tolerated dose     (MTD) of autologous dendritic cells (DCs) loaded with allogeneic brain tumor stem cells     administered as a vaccination in children and adults with recurrent brain tumors. Once the     MTD has been determined, we will conduct a phase II study to determine efficacy.      Clinical trials that utilize DCs for immunotherapy have demonstrated significant survival     benefit for patients who exhibit robust immune responses against tumor cells. Unfortunately,     at the present time the majority of tumor patients are unable to mount an adequate immune     response and thus succumb to their tumors. We postulate that the inability to generate an     appropriate immune response in these patients is due to a lack of sufficient numbers of     appropriate T cells due to an inadequate source of tumor antigens.   "
253316|NCT01171482|"     The aim of this study is to compare the efficacy of sorafenib to 5-fluorouracil/mitomycin in     HCC patients with pulmonary metastasis whose intrahepatic tumors has been controlled with     locoregional therapies.   "
253317|NCT01171495|"     Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve,     asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.   "
253318|NCT01171508|"     The purpose of this study is to investigate circadian disturbances after breast cancer     surgery by means of monitoring sleep and heart-rate variability, by measuring a metabolite of     melatonin in urine and by questionnaires and a sleep-diary.   "
253319|NCT01171521|"     Complex wounds that cannot be closed primarily are at great risk for complications. A new     technique utilizing external tissue expansion holds promise in rapidly decreasing wound area.     Facilitation of rapid wound closure is critical in preventing wound complications.      Hypothesis:      Using the Dermaclose Wound Management System (Woundcare Technologies, Inc., Chanhassen, MN)     in complex wounds not able to be primarily closed will decrease the time to secondary closure     and decrease the need for secondary soft tissue coverage procedures, or if secondary soft     tissue procedures are required, its use will decrease the size and complexity of the     secondary soft tissue procedures.      Null Hypothesis:      The Dermaclose system will not decrease the need, dimensions, or complexity of secondary soft     tissue coverage procedures in complex wounds not able to be primarily closed.   "
253320|NCT01171534|"     Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often     require multiple returns to surgery for closure, and occasionally require skin grafting (i.e.     they are never completely closed). We are interested in seeing whether this device, which     provides constant and gradual tension on the wound, may allow for rapid wound closure in a     safe fashion, perhaps even precluding a return trip to surgery.      Null hypothesis #1: The Dermaclose Wound Management System (Woundcare Technologies Inc,     Chanhassen, Minnesota) will not result in closure of fasciotomy wounds more rapidly than     standard vessel loop techniques.      Null hypothesis #2: The Dermaclose Wound Management System will not reduce the number of     return trips to the operating room for surgical procedures related to closure or skin     grafting of fasciotomy wounds.   "
253321|NCT01171547|"     The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with     suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous     hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation     for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.   "
253829|NCT01177254|"     Using a retrospective analysis of a large commercial claims database and a Medicare database,     the investigators evaluated DDEs that have the potential to cause DDIs among chronic low back     pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450     enzyme system, concomitant with other CYP450-metabolized drug(s).   "
253322|NCT01171560|"     In anesthetized patients the airway needs to be secured due to lack of protective reflexes.     Golden standard is the endotracheal intubation. In patients undergoing lung surgery single     lung ventilation is essential. In these cases a double lume tube is commonly used. The double     lume tube has a proximal tracheal and a distal bronchial end reaching into the left or the     right side of the lung dependant of the model of the tube. Thus it is possible to operate on     one collapsed side of the lung while ventilating the other side.      Due to length and stiffness resulting of the construction of the device more side effects     than after intubation with a conventional single lumen tube is expected. Possible side     effects may be bleeding, swelling, sore throat or croakiness.      The EZ-Blocker is a new device promising to overcome these side effects. The EZ-Blocker is a     device placing a balloon into one bronchus to be able to provide single lung ventilation like     the double lume tube. However, the EZ-Blocker is a catheter pushed through a conventional     single lume tube after intubation with a hook on one and a balloon on the other distal end.     The hook prevents the device from being pushed too far to be able to harm the lung. Inside     the EZ-Blocker is a small lumen able to deflate the lung which is blocked with the balloon.     The device is easily positioned using a bronchoscope and when the anaesthesiologists     confirmed the correct position of the device, the balloon can be inflated and deflated as     needed.      Due to the easier approach the investigators expect less side effects as mentioned earlier     using the EZ-Blocker compared to the double lume tube. As well the stress caused by     intubation may be reduced.   "
253323|NCT01171573|"     Polymyositis (PM), dermatomyositis (DM) and inclusion body myositis (IBM)belong to a group of     inflammatory muscle disorders, of unknown cause, that are characterised by skeletal muscle     inflammation and progressive muscular weakness, which can be debilitating and chronic in     nature (occasionally fatal).      The current treatment options for these conditions are steroids and various other     immunosuppressive drugs. However, these are usually only partially effective at reducing     symptoms, and their toxic side effects also limit their usefulness. In order to develop more     specific treatments for myositis in the future (and therefore more effective), it is     important to understand the exact mechanisms that cause the disease in the first instance. In     other similar inflammatory diseases such as rheumatoid arthritis (RA) and systemic lupus     (SLE), it is known that changes to the Human Leukocyte Antigen(HLA), as well as certain     inflammatory cytokines, are involved in both the development and expression of the disease.      As many of the inflammatory mechanisms that cause damage in PM, DM and IBM are similar to     those in RA and SLE, it seems likely that similar genetic factors will also be involved in     the development and expression of PM, DM and IBM.      In order to understand the genetic aspects / causes of myositis, and ultimately develop more     effective treatment therapies in the future, patients with PM, DM or IBM, will be asked to     give 20 mls of blood. These blood samples, along with the patient's clinical details, will     then be sent to the Centre for Integrated Genomic Medical Research (CIGMR), at The University     of Manchester, where all of the genetic analyses will take place. By understanding the     genetic cause of the disease, it should be possible to design specific drugs for treating the     condition in the future.   "
253324|NCT01171586|"     The purpose of the National Cancer Institute (NCI) funded randomized controlled study is to     develop and evaluate a text message (SMS) based weight loss intervention to 309 overweight or     moderately obese English and Spanish speaking adults ages 21 - 60. The investigators propose     that participants randomized to the intervention arms will lose significantly more weight     than those participants randomized to the control group.   "
253325|NCT01171599|"     The purpose of this National Cancer Institute (NCI) funded study is to develop and test the     acceptability and usability of a web & text message based weight loss intervention for     childhood acute lymphoblastic leukemia (ALL) survivors. Childhood cancer survivors ages 7 -     18 will provide feedback during focus groups on a web and text message based program that was     developed.   "
253326|NCT01171612|"     The purpose of this study is to evaluate and monitor perioperative management of patients     with coronary stents undergoing noncardiac surgery.      Objectives:        -  To describe the incidence and severity of adverse cardiovascular events in patients with          coronary stents undergoing noncardiac surgery with admission.        -  To assess the following-up of the guidelines about the perioperative management of          antiplatelet therapy in these patients.        -  To assess the relationship between the incidence of cardiac or neurovascular events, as          well as bleeding complications with the perioperative management of antiplatelet          therapy.        -  Number of Participants with Adverse Events as a Measure of Safety   "
253327|NCT01171625|"     The purpose of the study is to demonstrate the long term safety and effectiveness of the     Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve     replacement with or without concomitant procedures requiring cardiopulmonary bypass.   "
253328|NCT01171638|"     This is a prospective observational study to determine the reliability and accuracy of Near     Infrared Spectroscopy (NIRS) to detect oxygen flow in the extremities of injured and     non-injured soldiers over time. This technology may be useful in the detection of acute     compartment syndrome. We hypothesize that:        -  NIRS values will be well-correlated with intracompartmental pressure measurements        -  NIRS values will be significantly different between non-injured and injured extremities,          and injured extremities treated with fasciotomy for acute compartment syndrome.        -  NIRS values of the upper extremity and feet will correlate to values from normal legs in          critical control patients and patients with unilateral sever lower extremity injuries.   "
253329|NCT01171651|"     The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594     (Pexa-Vec) administered intravenously and intratumorally prior to standard sorafenib therapy.   "
253330|NCT01171664|"     To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom     scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on     placebo.   "
253376|NCT01172262|"     Tinnitus is a poorly understood symptom that is often described either as ringing, clicking,     ocean sounds, or nature sounds. There is no cure for tinnitus. Approximately 50 million     Americans are affected with a small minority being severely affected. This study targets     patients with tinnitus who are severely bothered. Through MRI the investigators plan to     evaluate the cortical networks of the brain in hopes to better understand this complex     process.   "
253331|NCT01171677|"     Addiction to illicit and prescribed drugs, alcohol and tobacco is associated with a panoply     of brain changes that contribute to structural and micro-structural deficits, altered     metabolism and neurotransmission, and related cognitive deficits affecting executive     function, decision-making, reward salience and motivation. Many of these deficits may act as     barriers to recovery, compromising the same spectrum of cognitive processes that established     interventions (motivational enhancement, cognitive behavioral therapy, therapeutic     communities, etc.) depend on for successful outcomes. Even where there are medications that     target a specific addiction (e.g., methadone for opiates), meaningful, sustained recovery     relies on the acquisition of adaptive skills and strategies. As such, there is a need to     develop interventions for substance use disorders that have the potential to improve health     and cognitive and psychosocial functioning, and to be embraced by the treatment community. A     growing body of basic and clinical research suggests that physical exercise may reduce drug     use and improve cognitive-executive function, mood, and motivation. There is also a growing     literature on the effectiveness of positive affirmation as a cognitive-behavioral     intervention for depression and PTSD both of which frequently co-occur with addiction.     Building on this, we hypothesize that a combined exercise and affirmation intervention     (IntenSati) will lead to improved cognitive and psychosocial function. To test this, we     propose to conduct a two-arm randomized clinical trial - in adult volunteers with a history     of longstanding substance use and who are in treatment in a residential therapeutic community     setting (Odyssey House) - to examine cognitive and psychosocial function before, during, and     after randomization to either a twelve-week IntenSati intervention condition or to a     twelve-week no-exercise/no-affirmations control condition. This is a pilot study intended to     collect data on feasibility and effect size. The population and sample size were selected on     the basis of likelihood to benefit from the intervention, likelihood for good adherence, and     the realities of completing a low-cost pilot study within a one-year timeframe. Overall there     were no substantial differences between IntenSati and TAU on measures of cognition, mood, and     psychosocial functioning. Limitations include the small sample size, limited exercise     intensity and capacity, missed exercise classes, dropout because of placement, work schedules     and non-study-related medical conditions.   "
253332|NCT01171690|"     This study evaluated the effects of teriparatide (Forteo) on low calcium levels in the     setting of thyroid surgery associated with low parathyroid hormone. The hypothesis was that     teriparatide ( Forteo) would shorten the length of hospitalization post thyroidectomy in     patients with symptomatic hypoparathyroidism.   "
253333|NCT01171703|"     The purpose of this trial is to find out the appropriate way to treat DM patients with     critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of     femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.   "
253334|NCT01171716|"     the purpose of this study is to identify how the body responds to increased dietary protein     (that includes pork and eggs) and meal-frequency in adult men. During this study, the changes     in blood glucose, hormones, appetite, and energy expenditure will be examined.   "
253335|NCT01171729|"     This is an open label, Phase I/IIa trial of immunotherapy with CreaVax-PC as treatment in men     with hormone-Refractory Metastatic Prostate Cancer.   "
253336|NCT01171742|"     Intermittent hepatic inflow occlusion (IHIO), also called Pringle maneuver, is a safe and     effective procedure for major hepatectomy in patients with liver disease. In addition,     ischemic preconditioning with IHIO has been reported to have protective effects in patients     undergoing liver resection. The role of IHIO, however, has not been fully elucidated in     donors and recipients during living donor liver transplantation.   "
253337|NCT01171755|"     In current study, we evaluate the efficacy of gemcitabine and TS-1 combination chemotherapy     in advanced BTC.   "
253338|NCT01171768|"     Vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) are major mediators of     angiogenesis and are induced by tissue inflammation and hypoxia. While elevated serum VEGF     levels have been reported in inflammatory lung diseases, especially with hemoptysis, there     was no study to evaluate the Ang-2 levels in lung inflammatory diseases according to the     presence of hemoptysis, inflammatory biomarker and hypoxia.   "
253339|NCT01171781|"     The study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe     based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal     carcinoma   "
253340|NCT01171794|"     This is a research study on Altitude Illness. From the information collected and studied in     this project we hope to learn more about Altitude Illness, including factors that may affect     and prevent the development and progression of this condition. We hope to learn if the     commonly used non-steroidal anti-inflammatory medication, ibuprofen can prevent altitude     illness. Possible participants in this study are healthy adults who indicated they would like     to participate, learn about altitude illness, and desire to hike Barcroft Peak. Stanford     University researchers hope to enroll about 100 participants.   "
253341|NCT01171807|"     The purpose of this study is to investigate the efficacy and safety of erythrocyte-mediated     delivery of dexamethasone in steroid-dependent ulcerative colitis patients   "
253342|NCT01171820|"     The purpose of this Clinical Evaluation is a continuation in the assessment of the     performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in     the treatment of patients with de novo coronary artery lesions in patients (Diabetic     sub-study).   "
253343|NCT01171833|"     Three groups of patients are going to have minor surgery under general anesthesia with     inhaled anesthetics and different ventilatory setting (Tidal volume: 8, 10, 12 ml/kg,     respiratory rate: 10/min each). Group A (Sevoflurane) will use sevoflurane, group B     (Desflurane) will use desflurane, and group C (Isoflurane) will use isoflurane. It will be     observed differences among the groups for ventilatory effects on speed of induction.      Duration of this randomised controlled trial will be about 3 months. Estimated sample size     will be 36 patients(12 in each group).   "
253344|NCT01171846|"     Pelvic organ prolapse is a problem experienced by women where a bulge comes down in the     vagina, and may even drop down outside the vagina. The bulge in the vagina is caused by other     organs moving down from their normal position in the pelvis and pushing into the vagina. This     is a very common problem and many women who have given birth will have a very mild bulge     which does not cause them symptoms. Women can however experience a variety of pelvic,     bladder, bowel and sexual symptoms which impact on daily life. No research studies have     properly examined whether or not exercises can prevent prolapse. This study aims to explore     whether exercises taught by a physiotherapist can prevent women developing a prolapse which     requires them to have treatment.   "
253386|NCT01172392|"     The purpose of this study is to assess the loss of HbsAg after a 48-week pegylated interferon     alpha 2a in patients with chronic hepatitis B (HBeAg negativation)   "
253436|NCT01173055|"     Fibromyalgia is a condition that includes pain, tenderness, stiff muscle, and fatigue.     Researchers want to find out if a drug called milnacipran can help people with     fibromyalgia. milnacipran (Savella) is approved by the FDA for the management of     fibromyalgia. In this study, milnacipran will be given to find out more about how it affects     pain and thinking in people with fibromyalgia.   "
253345|NCT01171859|"     This study is being conducted to explore the potential benefits of a twelve-month doxycycline     (at the best tolerated dose of 200 mg/day) and tauroursodeoxycholic acid (750 mg/day)     treatment on disease progression in patients affected by transthyretin amyloidosis,     including: 1) patients not eligible for liver transplantation; 2) patients eligible for liver     transplantation, as a bridge therapy between the time of diagnosis and surgery, with the     aim of stabilizing the disease; 3) patients showing disease progression after liver     transplantation performed since at least 1 year.      It is a phase II, therapeutic exploratory, two-part, 18-month, single centre, prospective     study.      Part I is a 12-month, open label treatment period in which doxycycline (200 mg/day,     continuously) and tauroursodeoxycholic acid (750 mg/day continuously) are administered to 40     consenting subjects with transthyretin amyloidosis. Part II is a withdrawal period in which     subjects will be monitored for disease progression. During part I, subjects will be evaluated     at baseline (study Day 0), and then after 3, 6, 9 and 12 months of doxycycline plus     tauroursodeoxycholic acid treatment or at premature treatment discontinuation; during part     II, they will be assessed at months 15 and 18. Monthly phone contacts and blood tests will be     performed to monitor potential adverse events.   "
253346|NCT01171872|"     The causes of inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis     (UC), are unknown and diagnosing them is often difficult. This research is being done to find     the genes that may increase the risk of inflammatory bowel disease, and to identify specific     protein substances that are related to IBD. The investigators are also looking at cell     factors that may predict response to treatment for IBD. In IBD, cells of the gastrointestinal     tract (your gut) do not seem to respond to certain substances in a normal way. Scientist have     discovered that the immune system, made up of cells and chemicals that defend your body from     infections, is working in a way that damages the walls of the gut. You are being asked to     join in this study because you are going to have an surgical procedure performed related to     your diagnosis of Crohn's disease or ulcerative colitis or for other medical reasons (for     comparison purposes). If you join this study, the investigators will study the cells in the     resected tissue from your gut to find out why some cells do not act in the normal way in     people with IBD as compared to people without IBD. The more the investigators understand     about how differently these cells are working, the better doctors and scientists will be able     to someday help people with IBD.   "
253347|NCT01171885|"     The objective of this study is to compare the postoperative analgesia afforded by bilateral     superficial cervical block using different concentrations of local anesthetic (ropivacaine)     in patients undergoing total thyroidectomy for the mini-incision technique, performed by the     same surgical team.   "
253348|NCT01171898|"     The purpose of this study is to assess the safety and activity of ARN-509 in men with     advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1     of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase     2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of     ARN-509.   "
253349|NCT01171911|"     Both calcium channel antagonist and beta-blocker have cardioprotective effect. Endothelial     shear stress is predictive factor of clinical outcomes in patients with obstructive stenosis.      The present study aims at comparing the re-distribution of shear stress and blood velocity     during whole cardiac cycle after trans-coronary injection of Nicardipine and esmolol.   "
253350|NCT01171924|"     This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and     neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a     multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human     epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is     designed to compare the safety and tolerability of CUDC-101 when administered at the maximum     tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.   "
253365|NCT01172119|"     Prospective, multi center, randomized, single blinded study designed to demonstrate the     safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery     System at multiple time points compared to the Taxus Liberte DES in the treatment of single     de novo native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.0 mm and ≤ 14     mm in length.   "
253366|NCT01172132|"     The purpose of this study is to determine:        -  Condition of intensive care unit (ICU) admission in patients with haematological          malignancies.        -  ICU hospital and up to one year mortality.        -  Assessment of post ICU burden and health related quality at 90-d and 1 year.   "
253351|NCT01171937|"     The proposed study attempts to deepen our understanding of repetitive behaviors in autism     spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits     associated with risperidone treatment using functional MRI. This study is a substudy of a     larger center grant (IRB#07-03-066). Other studies also under this center grant, include:     IRB#03-02-085, IRB#95-01-028. All participants will have the option to enter another     sub-study, should they meet criteria. The proposed study will address this aim by mounting a     controlled trial of 52 children with Autism Spectrum Disorder. After screening assessment,     children will enter a three-part study. Phase 1 will be an 8-week, double-blind,     placebo-controlled flexible dose trial of risperidone. The extension phase is a 16-week     open-label maintenance phase for responders to risperidone or placebo. Non-responders to     placebo will be invited to enroll in the eight-week open-label study. 48 of the participants     will also undergo fMRI at Week 8 while on blinded treatment, as an optional sub-study. The     medication will be dispensed in a liquid suspension and the dose will range from 0.5 mg to     4.0mg.   "
253352|NCT01171950|"     The purpose of the study is to evaluate the safety and effectiveness of the CentriMag     ventricular assist system to help pediatric patients who have experienced heart failure     during surgery and cannot be removed from cardiac bypass.   "
253353|NCT01171963|"     The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK     Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.   "
253354|NCT01171976|"     The purpose of this study is to demonstrate that two investigational treatment regimens have     the potential to result in a superior visual acuity improvement as compared to a ranibizumab     pro re nata (PRN=as needed) treatment regimen.   "
253355|NCT01171989|"     The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A     vaccine when administered as a booster dose following priming in the first year of life with     the same vaccine.      This protocol posting deals with objectives & outcome measures of the booster phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT00970307).   "
253356|NCT01172002|"     Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis   "
253413|NCT01172756|"     The aim of this study is to assess whether single oral doses of Riociguat safely improve the     cardiovascular function in patients with pulmonary hypertension associated with left     ventricular diastolic dysfunction   "
253357|NCT01172015|"     Immunologic thrombcytopenic purpura (ITP) affects both children and adults. The incidence is     estimated in adults about 1,6/100 000/per year. Chronic and relapsing forms of the disease     that represent 70% of adult cases are associated with impairment of quality of life related     to treatments side effects and bleeding. ITP is secondary to the destruction of circulating     platelets through an auto-immune process and to a decrease of platelet production in bone     marrow. Auto antibodies are usually directed against epitopes of the GPIIb/IIIa, expressed by     platelets. The destruction of the platelets seems to occur mainly in the spleen through     antibody dependent cytotoxicity. Both macrophages and cytotoxic T lymphocytes subsets     participate to the platelet destruction through the CD16, the low affinity receptor for the     Fc of IgG. Thus the CD16 pathway is a target for treatments in ITP as for example     intravenous immunoglobulins and more recently inhibitors of the syk kinase.   "
253358|NCT01172028|"     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells of by stopping them from dividing.     Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase I trial is studying the side effects and best dose of giving pemetrexed     disodium and docetaxel together in treating patients with advanced solid tumors.   "
253359|NCT01172041|"     This study will investigate whether audiovisual biofeedback, in which visual and audio cues     are used to regulate the patient's breathing, can increase the image quality of 4D CT and 4D     PET scans.   "
253360|NCT01172054|"     This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and     immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a     single dose vaccination on day 0.   "
253361|NCT01172067|"     The purpose of this study is to demonstrate that QuickOpt optimization can be as an     alternative method for CRTP/D patients' optimization in clinical practice through the     comparison of the improvement differences between the CRTP/D patients with different     optimization at 12 months after implantation.The hypothesis is that the Heart Remolding     parameter (LVESV) improvement of patients using QuickOpt parameters at 12 months after     implant is not inferior (10%) to the patients by Echo optimization。   "
253362|NCT01172080|"     Although systems are in place to ensure results of tests are communicated to patients, there     is currently no generalized accepted strategy to ensure that patients undergo recommended     follow-up testing. When follow-up tests are recommended months to years into the future,     there is a high likelihood that the test will either be delayed or not performed resulting in     the potential for poor outcomes and litigation. For this reason, there is a clear need for     systems to be developed which automatically trigger patient communication when the date of a     recommended follow-up test is approaching. The investigators propose to design a protocol for     ensuring that patients are reminded to schedule follow-up tests and that this communication     is documented in the online medical record. This work will provide the foundation for the     creation of systems that significantly improve patient care, and can be easily adapted for     use in many clinical departments and institutions.      Aim 1. To use patient focus groups to help design a system for improving adherence to     endoscopy follow up recommendations      Aim 2. To develop a prototype endoscopy follow up system and test the effectiveness of the     system on a cohort of patients due for a surveillance colonoscopy.   "
253363|NCT01172093|"     OSA is prevalent among patients with type II DM   "
253364|NCT01172106|"     There is currently no clear involvement of families/caregivers in the care for postpartum     mothers that develop postpartum psychosis. The lack of knowledge on causes of postpartum     psychosis may influence the nature of perceived social support that mothers receive from     caregivers. It is hoped that the provision of a culturally adapted version of family     psychoeducation will bridge the knowledge gap and provide the much needed information. We     therefore hypothesized that the involvement of a family member of a postpartum mother with a     psychotic illness in a weekly session of family psychoeducation.   "
253368|NCT01172158|"     Ureteral stents has become an indispensable instrument for urology practice as a result of     widespread use of endourological interventions. Removal of stents could be sometimes     neglected by patients or physicians. This omission may lead to legal and medical problems for     urologists, health institutions and also for patients. In this study, the investigators offer     a computer program providing two sided recall to prevent this nasty complication with sending     automatic message by short message service (SMS) to both the patient and the urologist.   "
253375|NCT01172249|"     This is an open, prospective, randomized, controlled, parallel, multicenter, non-inferiority     study in 250 individuals (125 individuals per group), with 204 evaluable patients with     clinical and radiological diagnosis of osteoarthritis of the knee.      Individuals will be randomized to receive during 180 days the test drug(glucosamine sulfate     500 mg + sodium chondroitin sulfate 400 mg - Mantecorp) or the reference medication     (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Condroflex®).      Efficacy will be evaluated through the clinical picture, pain visual analog scale, swelling,     stiffness in the joint, consumption of paracetamol and quality of life.      The safety assessment will be done by monitoring the incidence of adverse events and their     relation to the treatment.   "
253414|NCT01172769|"     The purpose of this study is to determine whether temsirolimus is effective in the treatment     of relapsed/recurrent squamous cell cancer of the head and neck (HNSCC)   "
253415|NCT01172782|"     The purpose of this study is to evaluate the adequate dose of intrathecal hydromorphone     injection for postoperative pain relief after knee arthroscopic surgery.   "
253369|NCT01172171|"     In Denmark, 12.000 people a year, is struck by acute myocardial infarction. A third of these     cannot be saved before treatment is possible.      Despite quick and effective reperfusion of the coronary arteries using PCI (Percutaneous     Coronary Intervention) after an acute ST-elevation myocardial infarction, substantial     morbidity and mortality remain. Infarct size is an important determinant of the short-and     long-term outcome after acute myocardial infarction. The most widely used and most effective     proven therapy to limit infarct size is the early reperfusion induced by or PCI.      Although beneficial in terms of myocardial salvage, reperfusion itself may contribute to     additional damage of the myocardium; the damage due to the combined processes is known as     ischemia-reperfusion injury. The pathogenesis of myocardial ischemia-reperfusion injury is     a multifactorial process involving the interaction of multiple mechanisms. Numerous studies     indicate that there are three pivotal factors in the pathogenesis of ischemia-reperfusion     injury: elevated oxidative damage, depressed energy metabolism, and altered calcium     homeostasis.      Partially reduced species of oxygen, including the superoxide anion radical, hydroxyl     radical, and hydrogen peroxide, are generated intracellularly as by-product of oxygen     metabolism. These reactive oxygen species cause peroxidation af membrane lipids, denaturation     of proteins, and modification of DNA, all of which ultimately can lead to cell death. In     mammals, cell damage induced by partially reduced oxygen species can also initiate local     inflammatory responses, which then lead to further oxidant-mediated tissue injury.      Melatonin is mainly known for its role as an endogenously produced circadian hormone.      For the last twenty years, increasing evidence has proven melatonin to be a very potent     direct and indirect antioxidant.      Recent experimental studies have documented the beneficial effects of melatonin in reducing     tissue damage and limiting cardiac pathophysiology in models of experimental     ischemia-reperfusion.      Primary hypothesis: Melatonin given to patients undergoing PCI can reduce the myocardial     damage sustained by ischemia-reperfusion.   "
253370|NCT01172184|"     A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is     associated with a poor outcome, regardless of systolic function. Thus, the LA volume provides     a long-term view of whether the patient has diastolic dysfunction, regardless of the loading     conditions present at the examination, such as hemoglobin A1c in diabetes mellitus. To date,     the relation between the LA volume and left ventricular (LV) filling pressure has not been     confirmed directly by simultaneous echocardiographic catheterization. The present study,     therefore, assessed the correlation between the LA volume and LV filling pressure in patients     with severe mitral regurgitation (MR). Because the LA pressure increases to maintain adequate     LV diastolic filling, increased atrial wall tension tends to dilate the chamber and stretch     the atrial myocardium. Therefore, the lower the ability of the left atrium to stretch, the     greater the pressure in the left atrium. The study is designed to assess 1) the relationship     between LV filling pressure and LA distensibility, and 2) the power of left atrial     distensibility to predict the prognosis, including operation mortality, the rate of     post-operation atrial fibrillation, and late heart failure event in patients with severe     mitral regurgitation.   "
253371|NCT01172197|"     The anaesthetic management of patients undergoing total knee replacement is still not     standardised. Epidural analgesia is common, but is associated with bilateral lower limb motor     block and limited mobilisation. Spinal anaesthesia with intrathecal morphine provides good     pain relief, but only for 12 to 16 hours, and is often associated with nausea and vomiting.     Combined single injection femoral / sciatic blocks give good pain relief, but for a variable     length of time (between 12 and 24 hours).      In contrast, continuous femoral perineural infusion of local anaesthetic provides very good     pain relief for several days. Pain relief is maintained by a constant infusion of local     anaesthetic using an elastomeric ball. The investigators overriding aim is to develop a local     anaesthetic regimen which offers complete pain relief for at least 48 hours, yet allows full     mobilisation within 24 hours Given that ropivacaine may offer a more advantageous     pharmacological profile (less lipid solubility) compared to levobupivacaine, the     investigators feel it is pertinent to investigate the capacity of ropivacaine to prevent pain     relief after surgery. Thus, the investigators aim in this study is to compare the ED50 of     levobupivacaine with the ED50 of ropivacaine for preventive pain relief after total knee     replacement. Further, calculation of the equipotent ED50's of each local anaesthetic allied     to objective measurement of quadriceps motor block using an electromyogram (EMG) will allow     us to determine the sensory - motor split of each local anaesthetic.   "
253392|NCT01172470|"     The purpose of this study is to determine 1-year survival of previously irradiated Head and     Neck cancer (HNC) patients with loco-regional recurrent disease treated with induction     chemotherapy with pemetrexed and gemcitabine followed concomitant pemetrexed, carboplatin and     daily radiotherapy.   "
253407|NCT01172665|"     The focus of this study is to create a database containing information about patients with     celiac disease. This database will allow us to examine clinical and epidemiologic features of     the University of Chicago Medical Center patient population. We have the largest population     of patients with celiac disease in the mid-West and as such this study using information     gathered from our database can greatly contribute to our current understanding of this     disease.   "
253408|NCT01172691|"     This study is being done to determine if patients receiving (iNO) will have increased liver     function and less damage from IR than patients who do not receive (iNO).   "
253372|NCT01172210|"     A substantial percentage of individuals with bulimia nervosa (BN) also meet criteria for a     co-occurring substance use disorder, such as alcohol abuse or dependence; however, research     examining this sub-group of patients with BN is limited. Understanding characteristics common     to both eating and alcohol use disorders may enhance understanding of the mechanisms that     could contribute to the co-occurrence and perpetuation of these disorders. Individuals with     BN and alcohol use disorders appear to share some behavioral traits, and therefore, the     primary aim of the current study is to compare patients with BN with and without an alcohol     use disorder and normal controls on measures assessing an individual's mood and ability to     perform certain tasks. Participants will be asked to complete computer-administered and     paper-and-pencil assessments and two laboratory test meals on separate days. By probing the     underpinnings of BN and alcohol use disorders, the investigators can determine whether these     disorders have a shared diathesis, which will lay an essential foundation for future research     to examine biological and genetic correlates of these disorders. Finally, as little is known     about the treatment of patients with BN and a co-occurring alcohol use disorder, an     exploratory aim of the current study is evaluate the suitability and efficacy of a 20-session     cognitive-behavioral treatment (CBT) addressing both bulimic symptoms and alcohol use.   "
253373|NCT01172223|"     Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or     amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with        -  Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m^2 i.v. day 1 q3 weeks),        -  Paclitaxel (175 mg/m^2 i.v. day 1 q3 weeks), and        -  Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive          surgery) Treatment is planned for 6 cycles unless there is evidence of unacceptable          toxicity, disease progression or inadequate efficacy (defined as a decrease in tumor          size <25% after 4 courses measured by ultrasound or MR-mammography), or if the patient          requested to be released.   "
253374|NCT01172236|"     The main objective of the study is to evaluate the antioxidant effect of lactoferrin and its     ability to reduce free radicals related diseases in the newborn. This evaluation will be done     through the assessment of neuro-developmental follow-up.      The secondary objective is to identify a panel of markers for assessing oxidative stress and     for a correlation with the lactoferrin antioxidant effect.   "
253437|NCT01173068|"     The aim of this study is to determine the outcomes when using ertapenem for complicated     urinary tract infections in the OPAt setting.      The study hypothesis: Ertapenem is an efficacious and safe therapeutic option for complicated     urinary tract infections in the OPAt setting.   "
253377|NCT01172275|"     Pediatric Obsessive-Compulsive Disorder (OCD) affects 1-3% of children. The investigators     currently have effective first-line interventions for pediatric OCD such as Cognitive     Behavioral Therapy (CBT) and pharmacotherapy with serotonin reuptake inhibitors (SRIs).     However, roughly half of children with OCD still have clinically significant OCD symptoms     despite treatment with first-line pharmacological treatments and CBT interventions for OCD.     Furthermore, all pharmacological treatments for OCD in children have an increased side effect     burden when compared to adults. Novel treatments for children with OCD are needed.      N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and a glutamate     modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in     this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with     NAC is nausea and this side-effect is seldom seen in the doses used in this trial.      NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled     trial in adults with trichotillomania (chronic hair pulling). Trichotillomania is an     obsessive-compulsive spectrum disorder that is hypothesized to be closely related to OCD. In     other trials NAC has evidence of some efficacy in treating diverse psychiatric conditions     such as bipolar depression, schizophrenia and cocaine dependence.      The investigators are conducting this trial to determine if NAC is effective in treating OCD.   "
253378|NCT01172288|"     Tourette syndrome is a childhood-onset neuropsychiatric disorder characterized by multiple     motor and vocal tics that last for at least a year in duration. Currently, there exist     several effective pharmacological treatments for childhood tics including alpha-2 agonist     medications (guanfacine and clonidine) and neuroleptics (antipsychotic) medications. These     medications, however, have significant side-effects and are only partially efficacy in     treating tics.      N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and glutamate     modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in     this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with     NAC is nausea and this side-effect is seldom seen in the doses used in this trial.      NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled     trial in adults with trichotillomania (chronic hair pulling). Hairpulling is hypothesized to     be closely related to tics because these conditions (1) have similar clinical characteristics     -- both groups typically experience urges before engaging in pulling or tics, (2)     neuroimaging studies suggest they involve similar brain circuits -- the basal ganglia, (3)     the same pharmacological treatments (neuroleptics) may be effective for both conditions and     (4) they tend to be inherited together in families. In other trials NAC has evidence of some     efficacy in treating diverse psychiatric conditions such as bipolar depression, schizophrenia     and cocaine dependence.      The investigators are conducting this trial to determine if NAC is an effective treatment for     tics.   "
253405|NCT01172639|"     The Combinatietherapie Bij Reumatoide Artritis (CoBRA) trial was a milestone in the     development of the present treatment paradigm for Rheumatoid Arthritis (RA). This study     introduced the principle of fast remission induction by means of a combination of standard     Disease Modifying AntiRheumatic Drugs (DMARDs) and a step down bridge therapy with high dose     glucocorticoids in early Rheumatoid Arthritis.      The purpose of the present study is to compare different combinations of traditional DMARDs     and glucocorticoids, based on the original CoBRA protocol, for treatment of early Rheumatoid     Arthritis.      Besides the efficacy and effectiveness of these strategies, patient centered outcomes and     potential implementation problems of such treatment strategies are evaluated.   "
253406|NCT01172652|"     The specific aim of this study is to evaluate the efficacy, tolerability, and safety of     ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar     disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current     at least moderately severe anxiety.   "
253379|NCT01172301|"     Malnutrition, including muscle wasting commonly occurs in children with cystic fibrosis (CF),     negatively influencing their quality of life and survival. At the time of a diagnosis of CF,     severe protein deficits can already be present. It is important to get CF children fed     adequately to prevent that their condition becomes worse or that recovery takes longer. Oral     supplementation trials showed that gains in lean body mass are difficult to achieve in CF     unless specific metabolic abnormalities are targeted. However, the specific needs for certain     food components are not clear yet in children that are ill. Therefore, more information is     necessary on the need for protein and certain amino acids in children with CF. Previous     studies support the concept of essential amino acids (EAA) as an anabolic stimulus in the     young and elderly and in insulin resistant states. Until yet no information is present on the     anabolic effects of EAA in CF.      It is therefore our hypothesis that a high-leucine essential amino acids mixture specifically     designed to stimulate protein anabolism will target the metabolic alterations of pediatric     subjects with CF. In the present proposal, the acute metabolic effects of this high leucine     essential amino acids mixture will be examined in pediatric subjects with CF and compared to     that of a regular balanced total mixture of essential and non-essential amino acids. The     principal endpoints will be the extent of stimulation of whole body protein synthesis as this     is the principal mechanism by which either amino acid or protein intake causes muscle     anabolism, and the reduction in endogenous protein breakdown. Both endpoints will be assessed     by isotope methodology which is thought to be the reference method.   "
253380|NCT01172314|"     Weight loss commonly occurs in lung cancer patients, negatively influencing their quality of     life, treatment response and survival. Gains in lean body mass are difficult to achieve in     cancer unless specific metabolic abnormalities are targeted. It is our hypothesis that a     nutritional supplement containing a high amount of essential amino acids will target the     metabolic alterations of cancer patients. Preliminary research performed in our laboratory in     elderly supports this hypothesis. We hypothesize that intake of an essential amino acid     nutritional supplement will positively influence protein synthesis rate in advanced non-small     cell lung cancer (NSCLC) patients. Furthermore, insight in the underlying mechanism of the     higher anabolic response of the essential amino acid supplement will be examined. This     information will potentially enable us to formulate a supplement that is more effective than     normal food intake, and that will reduce the need for muscle protein breakdown.   "
253381|NCT01172327|"     The purpose of this study is to examine the effectiveness and safety of a self-directed     physical activity program relative to a self-directed dietary program in adults with     arthritis. A process evaluation will also be conducted to examine program reach,     participation/dose, fidelity, and participant compatibility/satisfaction.   "
253382|NCT01172340|"     The purpose is to determine if a culturally tailored diet and exercise intervention of 16     weekly sessions with 8 weeks of followup phone support is effective in reducing waist     circumference, weight, and related diet and exercise behaviors among women from underserved     communities.   "
253383|NCT01172353|"     The purpose of this study is to determine whether hydration with sodium bicarbonate is     superior to hydration with saline to prevent contrast-induced nephropathy.   "
253384|NCT01172366|"     The hypotheses for this study is that there is no transfer of testosterone from male (donor)     subjects to female (recipient) subjects when contact is made 2 hours post application of 2%     Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.   "
253385|NCT01172379|"     The purpose of this study is to investigate the safety, tolerability and efficacy of E2007 in     Parkinson's Disease patients who have wearing off motor fluctuations and on period     dyskenisias.   "
253387|NCT01172405|"     Based on established therapeutic effect of ibuprofen in the treatment of headache attacks,     and the action of caffeine in promoting better results when combined with treatments of first     choice in the treatment of headache, this study is designed to:        -  evaluate the efficacy of therapy with ibuprofen + caffeine in headache patients compared          to ibuprofen alone;        -  evaluate the tolerability of the association ibuprofen + caffeine compared to ibuprofen          alone.      The hypothesis is that the association is superior to treatment with ibuprofen alone in terms     of efficacy, while maintaining good tolerability.   "
253388|NCT01172418|"     The purpose of the present study is to determine which antibody induction regimen will result     in a safer and more effective method to use with steroid avoidance in renal transplant     recipients. Patients receiving either first cadaveric or non-HLA identical living donor     kidney transplants will be preoperatively randomized into 2 groups.   "
253389|NCT01172431|"     The purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal     function, endothelial function, blood pressure variability by comparison with     hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and     Hypertension.   "
253390|NCT01172444|"     An Investigator-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Establish     Therapeutic Equivalence of 1000 mg Mesalamine Rectal Suppositories and Canasa® Rectal     Suppositories (1000 mg Mesalamine, USP) in the Treatment of Mild to Moderate Ulcerative     Proctitis will be conducted in 533 patient with a estimated duration of 18months.   "
253391|NCT01172457|"     The aim of this study is to assess the efficacy and safety of ozone therapy (vs. placebo)     applied into the epidural space through epiduroscopy in Patients with Failed Back Surgery     Syndrome. It´s a Prospective, double blind, randomized study. The investigators will study 30     patients of both sexes between 18 and 70 years with chronic back pain after lumbar spine     surgery for more than six months. The patients will receive the ozone gas or placebo (oxygen)     in the lumbar epidural space, using a spinal endoscope inserted through the sacral hiatus by     local anesthesia or sedation. The patients will be evaluated before the procedure, with 30     days, with 3, 6 and 12 months after intervention. This will be run by a researcher who will     have no knowledge of the gas (oxygen or ozone) to be injected into the lumbar epidural space     with the aid of an epiduroscopic. Will be applied before and after the procedure, pain scales     (VAS, McGill, Neuropathic Pain 4, Neuropathic Pain Symptom Inventory), quality of life scale     (WHOQOL), functional scales of pain disability (Roland Morris and Oswestry Disabilities     Scales). Only one researcher will keep the data confidential until the end of the study.   "
253393|NCT01172483|"     Summary: (Objectives and methodology of the project) AIM: To evaluate the clinical     effectiveness of Community physiotherapy intervention on chronic diseases (heart disease,     chronic obstructive pulmonary disease, back pain, mechanical neck pain, fibromyalgia,     osteoarthritis lower limbs, neurological and cancer survivors) and a group of healthy     patients cardiovascular risk factors. DESIGN: Randomized, controlled, prospective study.     SUBJECTS OF STUDY: Patients with chronic disease go to the Local Sports Torremolinos Center     INTERVENTION: Establishment of a control group that give you some advice education care     (brief advice) and a group common experimental multimodal program of 12 weeks therapeutic     exercise with health education (brief advice). It will follow up complete with ratings pre     and post intervention to both groups and follow up at 6 and 12 months for long-term effect     through specific questionnaires for each subgroup chronic disease and pain score (visual     scale analog), quality of life (EuroQol-5D) and state health general (Short-Form 12, SF-12)     VARIABLES: The intervention physical therapy Community. Result: Specific questionnaires for     each subgroup, pain (Visual analogue scale), quality of life (EuroQoL) and general health     status (SF-12). DATA ANALYSIS: descriptive statistics, measuring central tendency and     dispersion of the variables study. Inferential statistics will be made between intervention     of key variables and outcome (Chi square, Student t, ANOVA, Mann-Whitney, Wilcoxon, by type     and normal variables). Likewise, establish measures of effect size in main outcome variables,     by reduction relative risk, absolute risk and odds ratio with their respective confidence     intervals.   "
253394|NCT01172496|"     This single center, open label, randomized, two-period, two-sequence cross-over study is     designed to evaluate the relative bioavailability of a treprostinil diethanolamine 1 mg     tablet in reference to treprostinil diethanolamine 1 mg oral solution (administered as four     0.25 mg doses every 2 hours for a 1 mg total dose) in twenty-four healthy volunteers. Other     secondary outcomes of interest include assessment of pharmacokinetic parameters of     treprostinil diethanolamine 1 mg tablets and a treprostinil diethanolamine 1 mg oral solution     administered as four doses (0.25 mg every 2 hours for a 1 mg total dose) and evaluation of     the safety and tolerability of each treatment regimen.   "
253395|NCT01172509|"     Our overall objective is to apply Transcranial Magnetic Stimulation (TMS) to develop measures     of human synaptic plasticity and of brain excitatory:inhibitory ratio (E:I ratio), which we     propose as novel biomarkers and outcome measures that will expedite clinical trials of     treatments for Autism Spectrum Disorder (ASD). One potential therapeutic agent, R-baclofen     will be investigated under this protocol.      TMS is a safe, inexpensive and noninvasive means to focally stimulate the human brain.     Presently, TMS is in extensive use as a means to measure regional brain excitability, which     is dependent on local synaptic strength. TMS can be used to temporarily alter synaptic     strength as well as to acutely measure levels of cortical excitability and short and long     interval inhibition. Since altered synaptic plasticity and an imbalanced     inhibitory:excitatory ratio are cited as fundamental abnormalities in ASD, we hypothesize     that both severity of ASD-related learning deficits and their improvement after therapy will     correlate with TMS measures of synaptic plasticity and E:I ratio. We propose to embed TMS     measures of synaptic plasticity and E:I ratio in a 'Proof of Principal' trial of R-baclofen     and to examine:      Aim 1: Whether R-baclofen (a potential therapeutic agent for ASD) predictably alters TMS     measures of synaptic plasticity and E:I ratio as a function of plasma concentration in adult     volunteers. We will test the following hypotheses:        1. R-baclofen produces a significant change in TMS measures of LTD and E:I ratio; and        2. R-baclofen plasma levels and TMS measures of LTD and E:I ratio show a predictable          exposure-response relationship.      Exploratory Aim 1: Whether the presence of genetic polymorphisms of the BDNF and GABA-B     receptor genes has a moderating effect on TMS measures and on R-baclofen effects. We will     test the following hypotheses:        1. Presence of the BDNF val66met allele will be associated with decreased long-term          depression (LTD) of cortical excitability        2. Polymorphisms of GABA-B receptor genes will be associated with altered magnitude of          response to R-baclofen as measured by TMS   "
253396|NCT01172522|"     This study examines topical treatment of under eye circles and swelling.   "
253438|NCT01173081|"     This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive     use of teriparatide for the healing of Jones fractures.   "
253397|NCT01172535|"     Treatment of children and infants with HIV requires modification of medication dosing     according to a child's specific weight. For lopinavir/ritonavir (LPV/r), a second line     treatment option that is increasingly necessary due to infant drug resistance, this dosing is     often complicated and impractical in busy clinical settings. To address this, the World     Health Organization (WHO) has released a simplified dosing table based on infant weight     bands. This study will evaluate the absorption, safety, and tolerance of LPV/r in infants     when dosed according to the new WHO guidelines.   "
253398|NCT01172548|"     GISTs are the most common mesenchymal tumors of the gastrointestinal tract. Approximately 95%     of GISTs are positive for KIT (CD117)-the receptor for stem cell factor (SCF). GISTs are not     responsive to conventional cytotoxic chemotherapy and disease often recurs even after     complete resection with wide margins.      Imatinib mesylate (trade names: Glivec® and Gleevec®, imatinib, formerly STI571) is a signal     transduction inhibitor targeting several protein-tyrosine kinases that are believed to play a     role in the proliferation of tumor cells. In the Phase II study of imatinib [CSTI571B 2222]     in 147 patients with recurrent or metastatic GIST, the partial response rates were 67% and     66% in patients treated at 400 mg/d and 600 mg/d, respectively. Skin rash and elevated     transaminases were the most common reason for drug discontinuation. The most frequently     reported AEs were mild nausea, vomiting, diarrhea, superficial edema (primarily periorbital     or lower limb), myalgia and muscle cramps. Grade 3/4 events included fluid retention (pleural     or pericardial effusions, ascites, and pulmonary edema), skin rash, liver toxicity and     gastrointestinal (GI) hemorrhage. Myelosuppression (neutropenia and thrombocytopenia) was a     consistent finding. Also, a tumor lysis-like syndrome occurred in some patients leading to     gastrointestinal (GI) and/or intratumoral hemorrhage.      In a Phase 3, American College of Surgeons Oncology Group trial (ACOSOG Z9001) of adjuvant     imatinib, imatinib significantly improved 1-year recurrence-free survival (RFS) compared with     placebo.      In summary, clinical trials have shown that imatinib produces clinical benefit in most     patients with unresectable or metastatic GIST and extends median survival from 19 to 57     months. Imatinib is the standard of care for advanced GIST and has received regulatory     approval for the treatment of unresectable or metastatic GIST. Studies suggest that adjuvant     imatinib for 1 year prolongs RFS in patients at high risk of recurrent disease and metastases     following complete surgical resection of the primary GIST.      Imatinib is an appealing adjuvant therapy for resected GIST because:        1. Patients with primary GIST have a high chance of tumor recurrence        2. Conventional adjuvant treatment modalities are ineffective        3. Imatinib specifically inhibits the Kit receptor which is constitutively activated in          most GISTs        4. Imatinib inhibits the growth of Kit positive cells in vitro        5. Imatinib is highly effective in many patients with advanced GIST in a Phase II trial        6. Imatinib has been associated with minimal toxicity in patients with advanced GIST and in          patients with chronic myelogenous leukemia (CML)        7. Imatinib may have its greatest impact on survival when there is minimal disease.      Primary        -  To assess Recurrence Free Survival Rate in patients with resected primary GIST who are          treated with adjuvant imatinib for a duration of 2 years Secondary        -  To compare Recurrence Free Survival, Overall Survival, and Time to Recurrence of          patients with resected primary GIST who are treated with adjuvant imatinib for a          duration of 2 years with historical data To assess the safety of imatinib given as          adjuvant therapy for 2 years in patients with resected primary GIST   "
253399|NCT01172561|"     To increase early detection of cervical cancer by increasing the proportion of Appalachian     women, age 18 and older, who receive Pap smears at appropriate intervals and return for     follow-up care when necessary.   "
253400|NCT01172574|"     The objective of this study was to explore the effectiveness of Motor Control Exercise on     pain, postural alignment and spinal curvatures in women with osteoporotic vertebral     fractures.   "
253401|NCT01172587|"     As they move from preadolescence to adolescence and adulthood, children need nurturing and     supportive environments to realize their potential. Unfortunately, many children reside in     destructive families that often result in negative short and long-term outcomes. As     well-chronicled in the scientific and lay press, an all-too-common example involves parental     substance abuse. Indeed, children living with a parent who abuses substances often have     significant emotional, behavioral, and social problems. It has long been recognized that     interventions are needed to address the clinical needs of these youth and to help prevent the     development of problems that may emerge in early adulthood. To date, the majority of     treatments have focused on either treating the children individually, or in the context of     family therapy. Although directly involving these youth in treatment may be ideal, the     majority of custodial parents who enter treatment for substance abuse are very reluctant to     allow their children to engage in individual or family therapy. Thus, interventions for     substance-abusing parents that do not directly involve children, but serve to improve the     family environment as a whole, may have the greatest potential for reaching the most children     and thereby positively influencing their overall adjustment and well-being.      From this vantage, a promising approach is Behavioral Couples Therapy [BCT] for alcoholism     and drug abuse, a comprehensive psychosocial intervention for substance abuse that focuses     both on reducing addiction severity, improving couple adjustment, reducing interparental     conflict and intimate partner violence (IPV), and improving the family environment and     psychological functioning. In a series of preliminary studies, the PI found that children     whose substance-abusing fathers and nonsubstance-abusing mothers participated in BCT     displayed higher psychosocial adjustment at posttreatment and during an extended follow-up     than youth whose substance-abusing fathers participated in individual-based treatment (IBT)     or whose parents participated in a couples-based attention control treatment. These findings     indicate that BCT may extend beyond the couple to their children and may provide an entry     point into the family system from which to improve the adjustment of these youth.      The present study is the next important step for this line of research. First, the present     study is a far more developed examination of the potential effects of BCT on multiple     dimensions of youth functioning, taken from multiple perspectives. Second, we do not know     how BCT works. The positive effects of BCT on parents (reduced addition severity, improved     dyadic adjustment, reduced partner violence, improved parenting, and improved parental     psychological adjustment) may have positive trickle down effects on youth; however, we have     not undertaken an empirical examination of these potential mechanisms of action. If we can     understand how it works, we will be able to use that information to refine BCT to enhance the     mechanisms that benefit youth. Thus, the present study will examine possible curative     mechanisms. Third, we have a very limited understanding for whom it works. Thus, we will     examine whether BCT may operate differently for children of different stages of development.     If we can understand this moderating effect, we may be able to develop and refine BCT to meet     the needs of families with children of different ages.      To address these issues, the present study will examine how BCT is associated with changes in     the emotional and behavioral adjustment, beliefs, and behaviors, including serious problem     behaviors, of youth ages 5 to 18 (as rated by mothers, fathers, and the children themselves).     We will also focus on potential mechanisms of action that are positively influenced by BCT.   "
253402|NCT01172600|"     Epidural injection will be completed under fluoroscopy and all patients will receive 1-4 mg     of Midazolam for relaxation before procedure and, if needed, 50-100 mcg of Fentanyl     intravenous (IV). Radiopaque contrast (Omnipaque 300), for confirming the epidural position     of the needle, steroids and local anesthetic agents will be used according to the physician     performing the block and will not be controlled by the study. Patients will be randomly     assigned to receive either inhaled Entonox along with the interventional block they are     scheduled for or oxygen. They will be blinded about the treatment they are receiving. Those     randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and     also continue to receive it for a total of 4 hours in the recovery. Those randomized to the     oxygen group will receive oxygen through a similar mouthpiece for the entire duration of the     procedure and recovery for 4 hours. Following completion of procedure the patient will be     transferred to recovery and monitored for 3-5 hours then discharged home with instructions.     Possible side effects will be monitored and recorded, pain score of patient will be recorded     before discharge. All the patients will receive standard instructions regarding physical back     exercises. This will be repeated for every procedure up to maximum of three blocks.      The patients will be followed during each block and over a period of 1, 3, 6 and 12 months     and on each follow-up visit will complete computerized set of questionnaires as they did     before the procedure. The patients charts will be then reviewed for one year after the     initial procedure to determine if further epidural steroid injections or surgery for the     presenting problem were required. It is anticipated that the appropriate number of patients     will be enrolled within six months of study initiation.   "
253403|NCT01172613|"     The purpose of this study is to determine the appropriate concentration of diagnostic reagent     of house dust mite (Dp) to be used in diagnostic allergy skin prick test among Thai     population with allergic rhinitis.   "
253404|NCT01172626|"     The purpose of this study is to investigate the relationship between the side effects of     valproate sodium in the treatment of epilepsy in Han Chinese and the genetic polymorphisms of     drug metabolizing enzymes and pharmacokinetics of valproate sodium.   "
253558|NCT01174329|"     The objective of the study is to evaluate with clinical parameters the performance of     Saliwell Crown as a neuro-electrostimulator of the submandibular and sublingual salivary     glands in hypofunction status due to polypharmacy or Sjögren's Syndrome in patients with     symptoms of xerostomia.   "
253409|NCT01172704|"     This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults     (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and     secondary prevention intervention [Skills building and Motivational Interviewing (SB-MI) to     Care as Usual (CAU)]. The study setting is a large urban safety net Medical Center and     outcomes will be measured at 3, 6, and 12 months. The SB-MI intervention (3 sessions +     booster) was initially developed as the experimental condition in an R34 pilot project which     demonstrated its feasibility and promise. For the proposed project, the investigators will     recruit a larger sample which includes men and women with and without HIV, from various     ethnic and racial groups, sexual orientations and housing arrangements, as well as a range of     psychiatric disorders and functional capacities. In this way the investigators can more     rigorously demonstrate the promise of SB-MI with SMI. The investigators will also conduct a     sub-study after the 6 month follow-up to examine the impact at 12 months of an additional     booster session for SB-MI participants. The investigators specific aims are:        1. To examine the effectiveness of a brief, tailored primary and secondary risk reduction          strategy to CAU for people with serious mental illness. The desired outcomes include:             -  Decreased frequency of risk behaviors (number of partners, number of encounters)             -  Increased use of barrier precautions and IV needle cleaning             -  Positive changes in information and motivation, as well as risk behaviors             -  Increased HIV Counseling and Testing for those who do not know their HIV status        2. To examine the effectiveness of a 2nd booster session after the 6 month follow-up for ½          of participants randomized to SB-MI. The primary outcome will be:             -  Decreased frequency of risk behaviors and increased use of barrier precautions at               the 12 month follow-up   "
253410|NCT01172717|"     The primary hypothesis of this study is that panitumumab, an inhibitor of the epidermal     growth factor receptor (EGFR), is an effective treatment for carcinoid syndrome in people who     fail or do not adequately respond to octreotide or other supportive therapies.   "
253411|NCT01172730|"     The purpose of the study is to evaluate the use of ultrasound scanning of the thoracic spine     to define the point of insertion and the depth of the epidural space compared to the blind     technique.      The study hypothesis is the use of Ultrasound will improve the success rate of epidural     placement and may also decrease the rate of complications.   "
253412|NCT01172743|"     This protocol is designed to gather a small amount of blood for extraction of DNA for the     study of the genetic basis of diabetes. The study population will include individuals with     known diabetes, and controls without diabetes. Investigators aim to understand the genetics     of diabetes, and will use the cells and serum from this blood to perform genotyping and gene     expression studies of individuals with diabetes and relevant controls.   "
253416|NCT01172795|"     Diffuse noxious inhibitory control In order to quantify central sensitization in chronic pain     patients, the Diffuse Noxious Inhibitory Control (DNIC) model has been used frequently. DNIC     relies on painful conditioning stimulation of one part of the body to inhibit pain in another     part, to remove the noise and to focus on relevant stimuli.      Earlier studies provided evidence for malfunctioning of DNIC in Fibromyalgia (FM) patients.     However, the cause of this impairment is not yet elucidated, and further study is required to     unravel the pathophysiology of DNIC in FM.      Hypothalamus-Pituitary-Adrenal (HPA) axis Besides neural mechanisms, also hormonal     abnormalities could cause altered pain processing. Cortisol is released in answer to pain to     suppress the pain. Given the evidence for hypofunction of the hypothalamic-pituitary-adrenal     axis and the lower cortisol release in response to stressors in a proportion of FM patients     and in chronic whiplash associated disorders (WAD) patients, the relation between pain and     cortisol in these patients may be an interesting topic to consider.      Neurocognitive performance Besides chronic pain, people with chronic WAD and FM suffer from     severe concentration difficulties and decreased neurocognitive capabilities (reduced reaction     time, short term memory deficits etc. The decreased neurocognitive performance is known to be     related to pain severity in various chronic pain populations. It is hypothesized that     malfunctioning of descending inhibitory pathways and subsequent chronic pain experience     precludes optimal neurocognitive performance.      Objectives The present investigation addresses the (patho)physiological mechanisms of DNIC in     chronic pain populations.        1. Firstly, patients with FM, chronic WAD and healthy controls are compared regarding          functioning of DNIC, cortisol levels and response and neurocognitive performance          (case-control).        2. Secondly, the possible interaction between the functioning of DNIC, cortisol and          neurocognitive performance is studied in patients with FM, WAD and healthy control          subjects (cross-sectional).        3. Thirdly, to examine whether a fatiguing neurocognitive stressor changes DNIC and          cortisol levels in patients with FM, chronic WAD or healthy sedentary control subjects.   "
253417|NCT01172808|"     The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over     a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily).     Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of     maintenance treatment with inhaled corticosteroid controller medication in patients with     moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung     function, effects on asthma exacerbations, effects on quality of life, effects on asthma     control, effects on health care resource utilisation, and number of adverse events.   "
253418|NCT01172821|"     The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over     a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily).     Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of     maintenance treatment with inhaled corticosteroid controller medication in patients with     moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung     function, effects on asthma exacerbations, effects on quality of life, effects on asthma     control, effects on health care resource utilisation, and number of adverse events.   "
253419|NCT01172834|"     Strong evidence shows that physical activity (PA) has favorable psychological and health     related outcomes. However, most employees do not perform enough PA to achieve health and well     being benefits. Worksite interventions aimed at improving PA often yield modest effect sizes,     and their theoretical ground is not profound. The Health Action Process Approach (HAPA), is a     novel comprehensive theoretical model for health behavior change, that hasn't been studied as     a whole in a worksite intervention study.      The objectives of the proposed study are:        1. To develop a coaching-based group intervention that will be both grounded in theory          (HAPA) as well as applicable.        2. To evaluate the feasibility of conducting this intervention among employed hospital          nurses, using a randomized controlled design, interviews and other evaluation          procedures.      The proposed study will offer the most comprehensive empirical test to date of the full HAPA     model.   "
253420|NCT01172847|"     This open label, randomized, three-period crossover study will evaluate the effect of     co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of Tamiflu     and rimantadine. Healthy volunteers will receive multiple oral doses of Tamiflu, rimantadine     or Tamiflu plus rimantadine in random order, with a minimum wash-out period of 7 days between     treatments. Anticipated time on study is up to 11 weeks.   "
253457|NCT01167491|"     The investigators recently showed an abnormal expansion of NK-like CD4+ T cells in Wegener's     granulomatosis (WG), mainly in the diffuse vasculitis presentation. These cells expressed an     assortment of activating NK cell receptors and their signaling partners, in particular DAP12.     The investigators hypothesize that DAP12, or a downstream signaling target of DAP12, is the     missing link between the different cell components involved in WG (neutrophils, macrophages,     CD4 T cells).   "
253559|NCT01174342|"     The purpose of this study is to evaluate the effect of child delivery on the intraocular     pressure in healthy women.   "
253421|NCT01172860|"     A new approach to treating solid tumours (both operable and inoperable) has been carried out     by the Cork Cancer Research Centre (CCRC) at the Mercy University Hospital, Cork, Ireland     since 2002.      The approach simply allows a greater concentration of chemotherapy drugs to enter the tumour     cells rather than healthy cells. The uptake of the chemotherapeutic drug directly by the     tumour is aided through applying short electric pulses to the tumor mass (referred to as -     Electrochemotherapy or ECT). The pulses make the tumour more porous which allows the drug     easier access into the cancer cells, whereas other tissues and organs in the body remain     relatively poor at absorbing the drug, thereby reducing the potential side effects on healthy     tissues. This approach to date has been limited to skin based tumours due to the requirement     for the electrodes to be placed directly in contact with the tumour. Procedures with     electrochemotherapy have been applied to human patients in other countries of the EU, the US     and Japan.      The drug concentration used is significantly reduced due to the more targeted absorption by     the tumor and this significantly reduces side effects normally associated with chemotherapy.      A large number of preclinical and clinical Phase I and I/II studies have demonstrated the     efficiency and safety of ECT. These studies have included patients with melanoma, head and     neck squamous cell carcinoma, merkel cell carcinomas, basal cell carcinoma and adenocarcinoma     nodules. Case reports concerning other primary tumours have also been reported.      The investigators have developed an endoscopic approach (EndoVe system) for delivering the     electric pulses to internal cancers and are currently seeking to evaluate its efficacy in the     treatment of inoperable colorectal cancer. The treatment procedure is similar to standard     endoscopic colorectal examination (colonoscopy) with the added element of an intravenous     injection of bleomycin followed after eight minutes by the delivery of electric pulses (each     one less than 1msec in duration). The pulses are endoscopically delivered directly to the     tumour mass. The entire procedure is minimally invasive and does not require intensive care     follow up or stitches. If the treatment is successful the tumour will shrink in size in the     weeks following the procedure.      The objective of this study is to investigate the efficacy and safety of this approach in     reducing the size of the tumour.   "
253422|NCT01172873|"     This is a single site, open-label, feasibility study of cognitive behavioral therapy with     exposure and response prevention (CBT/ERP) adding the augmentation of D-cycloserine (DCS) for     adolescents ages 12-17 with Obsessive Compulsive Disorder (OCD) who are partial or     non-responders to first line treatments of CBT or pharmacotherapy.   "
253423|NCT01172886|"     Healthy women and women with breast cancer have been enrolled in our nested case-control     study between 2008 and 2009 in order to evaluate the association between metabolic syndrome     and breast cancer, analyzing anthropometric parameters blood pressure, assessing serum HDL-C,     triglyceride, fasting plasma glucose, insulin, testosterone and uric acid levels and     administering a questionnaire about physical activity, food intake, tobacco use, alcohol     abuse, personal and familial history of disease. Our data support the hypothesis that     metabolic syndrome may be an indicator of breast cancer risk in postmenopausal women. The     change of the hormonal arrangement in postmenopausal, along with an increase in visceral     adiposity, probably favour the hormone dependent cell proliferation, which drives     tumorigenesis. Adjustments in lifestyle with physical activity intensification and healthy     diet may represent modifiable factors on which sporadic breast cancer primary prevention may     work on.   "
253424|NCT01172899|"     Rationale:      In the Western world overweight and obesity is an increasing problem both in adults and in     children. In youth, it is associated with early death and a number of co-morbidities     including metabolic and endocrine changes, increased inflammatory status, cardiovascular     abnormalities, nonalcoholic fatty liver disease, and impaired quality of life.      The standard treatment for morbid obesity in children is by combined life style     interventions. However, the medium and long term effects of dietetic interventions, behaviour     therapy and medication is relatively poor. In adults bariatric surgery shows good results     with up to 30% weight reduction in 3 years. The preliminary results in youth are similar, but     surgery in this age group is relatively uncommon. In the Netherlands surgery in this age     group is only allowed in clinical trials, until the benefits and risks have been established.     (National Health Authorities)      Objective:      To determine if surgery gives a superior weight and body mass index (BMI) reduction than     combined life style interventions in adolescents with morbid obesity and to assess its effect     on obesity associated co-morbidity.      Study design:      Prospective randomised interventional study.      Study population:      Morbidly obese children, aged 14 - 16 years, with sex and age adjusted BMI >40 kg/m2 or >35     kg/m2 with co-morbidity.      Intervention:      Bariatric surgery by laparoscopic adjustable gastric band (LAGB) or combined life style     interventions      Main study parameters/endpoints:      Primary endpoints: weight loss, loss of excess weight, loss of excess BMI. Secondary     endpoints: Body composition, pubertal development, metabolic and endocrine changes,     inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, brain     development, quality of life, and behaviour changes. The potential complications of surgery     are monitored.   "
253425|NCT01172912|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. An autologous stem cell     transplant may be able to replace blood-forming cells that were destroyed by chemotherapy.      PURPOSE: This phase II trial is studying the side effects of giving high-dose chemotherapy     together with stem cell transplant and to see how well it works in treating patients with     metastatic germ cell tumors that have not responded to first-line therapy.   "
253426|NCT01172925|"     The feeling of shortness of breath is very common in lung cancer. It is uncomfortable for     patients and upsetting for their family. Although drugs like morphine and oxygen can help     some patients feel better, they don't help everybody, and they are not used in patients with     early symptoms. More relief is needed for these patients. The investigators are studying a     drug called tiotropium, which is used in emphysema. It is an inhaler that opens the airways     to allow easier breathing. Every patient will get the drug but also a placebo, in a random     (flip of a coin) order. They will get each for 2 weeks. The investigators will see if they     feel better with the drug.   "
253427|NCT01172938|"     The purpose of this study is to determine whether apremilast is safe and effective in the     treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms     of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated     patients.   "
253428|NCT01172951|"     The purpose of this study is to investigate the biological response to a metabolic stress,     given in the form of a high carbohydrate or fat meal in normal weight, overweight and obese     individuals and to further explore these responses using novel metabolomic, proteomic,     transcriptomic and genotyping techniques.   "
253429|NCT01172964|"     RATIONALE: Genetically-modified neural stem cells (NSCs) that convert 5-fluorocytosine (5-FC)     into the chemotherapy agent 5-FU (fluorouracil) at sites of tumor in the brain may be an     effective treatment for glioma.      PURPOSE: This clinical trial studies genetically-modified NSCs and 5-FC in patients     undergoing surgery for recurrent high-grade gliomas.   "
253430|NCT01172977|"     It is to be investigated if a correlation exist between the development of the HbA1c value     and the complication rate is following a stroke.   "
253431|NCT01172990|"     This is a pilot feasibility study to evaluate if patients with ST depression Acute Coronary     Syndrome who are taken directly to the catheter laboratory for angiogram and angioplasty +/-     stents will fare better that patients who are taken to the ward area and managed with drug     therapy and stabilised for 24 hours before being taken to the catheter laboratory.   "
253560|NCT01174355|"     A multicenter, open label, escalating dose study to assess the tolerability and the safety     and to explore the efficacy and the pharmacokinetics of ND0801 in adult patients with     attention deficit/hyperactivity disorder (ADHD).   "
253432|NCT01173003|"     This open-label study is being conducted to determine whether national expansion of a 400 mcg     of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of     mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.      The goal of this study is to provide answers to the following four questions:        1. What is the effectiveness of this regimen of medical abortion with mifepristone followed          by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)?        2. Are the side effects with sublingual use tolerable for women?        3. Is sublingual administration of misoprostol acceptable to women?        4. Are women satisfied with counseling and services received in new centers offering          medical abortion?   "
253433|NCT01173016|"     This is a single center pilot study in which Laronidase will be given weekly for two years in     patients with Hurler syndrome, also known as mucopolysaccharide IH (MPS I, Hurler syndrome),     that have previously been treated with an allogeneic transplant.   "
253434|NCT01173029|"     Renin-angiotensin-aldosterone system (RAAS) polymorphisms influence 24h arterial pressure     fluctuation. Resistant systemic arterial hypertension (RSAH) has an increased risk of end     organ damage and unfavourable prognosis, whereas pseudo-RSAH usually respond favourably to     drug therapy.      To prospectively investigate, in subjects with RSAH in a tropical South American city: 1)     Adverse cardiovascular events defined as fatal and non-fatal stroke or acute myocardial     infarction (AMI); and 2) the association of RAAS polymorphisms and adverse cardiovascular     events in this population.      Study population: 212 hypertensives recruited from primary care assistance (time since first     diagnosis of hypertension: 16.5±8.1 years) and without appropriate pressure control, between     2001 and 2006, corresponding to 0.48% of all hypertensives under care (18 new cases/year),     57±10 years old, 66% females. Under drug treatment schedule: three or more drugs including a     diuretic. Ninety two randomly selected hypertensives basis had renin-angiotensin-aldosterone     system genetic profile determined. Genetic assessment was carried out using a polymerase     chain reaction assay amplification technique. The following single nucleotide polymorphisms     were analyzed: renin (G1051A), angiotensinogen (M235T), angiotensin converting enzyme-ACE     (I/D), angiotensin II type 1 receptor (A1166C), aldosterone synthase (C344T) and     mineralocorticoid receptor (G3514C).   "
253435|NCT01173042|"     This pilot study will investigate the effects of acute peanut consumption on markers of     inflammation, triglycerides and glucose. The hypothesis is that a high glucose/SFA meal will     increase postprandial production of the inflammatory marker, C-reactive protein (CRP), and     that the addition of peanuts to the control meal will reduce the production of CRP, as well     as triglycerides and glucose.   "
253443|NCT01173146|"     Prostate Cancer is the most common cancer in men, affecting about as many men as women     diagnosed with breast cancer, and killing about as many men per year as breast cancer kills     women.      The most common surgical treatment is prostatectomy, the removal of the prostate. During     prostate surgery, tumor remains at the edge of the surgery, called residual tumor, in 30% of     all prostatectomies. Such patients have a significantly higher risk of local recurrence of     the cancer, and higher rates of death. In contrast, even patients with cancer outside of the     prostate, but still nearby the prostate, do better when the margins are made clean of tumor     during surgery.      The investigators propose to reduce the number of patients with residual tumor after surgery.     The investigators will test in patients a fluorescent molecule that allows cancer to be     detected during surgery. If this trial works as designed, the investigators will reduce the     number of patients who have to receive additional treatment, such as high doses of radiation     to the lower abdomen, because the amount of residual tumor left behind has been minimized.     This may also lead to higher rates of survival.      This type of detection of cancer the investigators employ is called Molecular imaging. The     investigators believe that molecular imaging will be the key to improved diagnosis,     individualized treatment selection, and treatment monitoring.      If successful, a large human trial will be conducted after this study with a corporate     imaging partner.   "
253444|NCT01173159|"     The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion     containing fish oil) instead of the current lipid emulsion, which contains fat derived from     soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better.     It may reduce the harmful effects to the liver, may stop any further liver damage and may     reverse damage already done to the liver because of the prolonged use of nutrition through     your child's IV.   "
253445|NCT01173172|"     This is a boron neutron capture (BNCT) therapy for patients with previously irradiated and     locally recurrent head and neck cancer. The primary end points are treatment toxicities and     response rate. The secondary endpoints are time to tumor progression, progression-free     survival, overall survival and change quality of life.      Head and neck carcinomas that recur locally after conventional irradiation pose a therapeutic     challenge. Boron neutron capture therapy (BNCT) is based on the nuclear capture reaction that     occurs when non-radioactive boron is irradiated with neutrons of thermal energy to yield high     energy alpha particles and recoiling lithium nuclei. The effect of alpha and 7Li is primarily     limited to boron- containing cells. Preferential uptake of boron into cancerous tissue is     achieved using boron carriers such as a derivative of phenylalanine, boronophenylalanine     (BPA). After administration of BPA by an intra-arterial or intravenous infusion, the tumor     site is irradiated with neutrons, the source of which is currently a nuclear reactor. A few     uncontrolled clinical trials have evaluated BNCT in the treatment of glioblastoma after brain     surgery. In these studies, the median survival times have been 13-15 months after BNCT.     However, efficacy and tolerability of BNCT in the treatment of limited number of head and     neck cancer patients showed promising results. Though many basic researches about BNCT has     been done using Tsing Hua Open-pool Reactor (THOR) at National Tsing Hua University, no     clinical trial utilizing BNCT is performed in our country. This study will be the first BNCT     trial to treat head and neck cancer in Taiwan.   "
253446|NCT01173198|"     To compare post-surgical outcomes in patients who have undergone Wavefront Guided LASIK     (iLASIK platform) compared with patients who have undergone Wavefront Optimized LASIK     (Wavelight Allegretto 400 Hz platform).   "
253577|NCT01174576|"     The purpose of the study is to investigate whether caffeinated and decaffeinated coffee     consumption has acute effects on subjective appetite feelings, energy intake and biochemical     markers related to appetite, inflammation and glucose metabolism compared to water     consumption.   "
253447|NCT01173211|"     The purpose of this study is to see how much antibody (proteins produced by the immune system     that help fight infections) the body makes after getting a flu vaccine. Researchers will also     look at how the body reacts to the flu vaccine and how it affects the babies of pregnant     women. The study will enroll approximately 240 women ages 18-39 years, including 180 pregnant     women in their second or third trimester of pregnancy (at least 14 weeks pregnant) and 60     non-pregnant women. Participants will be randomly (by chance) assigned to 1 of 3 vaccine     groups. Each participant will receive one shot of a 2010-2011 flu season licensed vaccine.     The vaccine will be given as an intramuscular injection (shot in the muscle) in the upper     arm. Study procedures include pregnancy testing, blood draws, and memory aids. Patient     participation may be up to 8 months. The information from this study will help guide     researchers in developing flu vaccines for pregnant women.   "
253448|NCT01173224|"     Influenza (flu) is a common respiratory infection and often causes severe illness. Few drugs     are currently approved to treat influenza. This research will test the safety of an     experimental anti-influenza drug called DAS181 that is given through an inhaler. The purpose     of this study is to evaluate the safety of this new medication and how the body reacts to it.     Any side effects will be measured by symptoms, physical examination or laboratory studies.     About 27 healthy men and women age 18-45, who meet screening requirements, will participate.     Three separate groups will be enrolled, with approximately 9 subjects in each group. Cohort     1:20 mg DAS181 or placebo for 1 day (total dose of 20 mg). Cohort 2: 20 mg DAS181 or placebo     for 10 consecutive days (total dose of 200 mg). Cohort 3: 30 mg DAS 181 or placebo for 1 day     (total dose of 30 mg.) Procedures include blood samples, electrocardiograms (measures heart     activity) and breathing tests.   "
253449|NCT01173237|"     With the development of the Intubation Surfactant Extubation technic, in which surfactant is     administered during a brief intubation followed by immediate extubation, surfactant therapy     can be given during nasal continuous positive airway pressure treatment further reducing need     for mechanical ventilation. Preterm newborn babies until eight hours of life, with     respiratory distress syndrome, will be randomized to standard delivery of surfactant via     endotracheal tube airway inserted after premedication for pain with midazolam and     remifentanil or to surfactant delivery via Proseal laryngeal mask airway size 1. The intent     is to is to compare efficacy and safety of surfactant administration via two different     airways and ventilatory approaches.   "
253450|NCT01173250|"     Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical     operation for management of ulcerative colitis and familial adenomatous polyposis. The     addition of diverting ileostomy may reduce septic complications. In this randomized study the     investigators compare two groups of patients with stapled ileoanal pouch one of them had     diverting ileostomy and in the other this step is omitted.   "
253451|NCT01167413|"     Fibromyalgia Syndrome (FMS) is a non - inflammatory condition characterized by the presence     of chronic, widespread musculoskeletal pain and tenderness; FMS is considered to be the     result of increased processing of pain by the central nervous system.      Axial spondyloarthropathy is the hallmark of Ankylosing Spondylitis (AS), an inflammatory     joint disease involving the axial spine, the sacroiliac joints as well as peripheral joints.      Although FMS and AS differ vastly in their pathogenesis, a considerable clinical overlap may     exist between these conditions. Both disorders typically cause chronic nocturnal back pain     and disturbed sleep may accompany either condition. In addition,the investigators have     previously described an increased prevalence of (secondary) FMS among female AS patients.      This overlap may have important clinical implications since the presence of comorbid FMS may     lead to increased severity results on commonly used instruments in the evaluation of disease     activity in AS, such as the BASDAI and BASFI .      Recently, the Assessment of Spondyloarthritis international Society (ASAS) has published     updated classification criteria for axial spondyloarthropathy. These criteria, which are     summarized in table 1, are based on the evaluation of patients suffering from chronic back     pain with an age of onset of less than 45.      Objective:      The objective of the current study is to evaluate the prevalence of axial     spondyloarthropathies among FMS patients, utilizing the new ASAS criteria.   "
253452|NCT01167426|"     This is an open-label, multicenter study conducted at approximately 20 sites. Each patient     will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall     injection satisfaction.   "
253453|NCT01167439|"     The investigators aimed to review the natural history of dysphagia and dysphonia in OPMD in     order to identify the best candidates and the proper timing to perform dysphagia alleviating     procedures in both heterozygote and homozygote patients from the large pool of cases with     this disease in Israel.   "
253454|NCT01167452|"     This study will find how weight affects the dosing of a drug called sulfamethoxazole and     trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives     is the same regardless of the patient's weight. The entire cohort was analyzed for the study     outcomes. BMI groups were for recruitment purposes only and were not used for ordinal data     analysis.      All sulfamethoxazole and trimethoprim (Trade name is Bactrim or Septra) medication that you     will receive in this study will be referred to as study medication within this informed     consent form. This drug is a combination of two antibiotics, sulfamethoxazole and     trimethoprim, which belongs to a class of medication known as sulfones and is approved by     the US Food and Drug Administration (FDA) for the treatment of a wide variety of bacterial     infections such as ear infections, urinary tract infections, bronchitis, traveler's diarrhea,     and Pneumocystis carinii pneumonia. Sulfamethoxazole and trimethoprim is given orally.   "
253455|NCT01167465|"     The purpose of this clinical observation is to evaluate the safety and consumers'     satisfaction of Moussik vs Desitin Creamy ointment as a diaper rash protection product.   "
253456|NCT01167478|"     The objective of this study is to verify if there is a neurophysiologic reserve when caffeine     and placebo perceived as caffeine are manipulated in closed- and opened-loop exercises.     Parameters of excitability level of skeletal muscle and Central Nervous System (CNS), and     peripheral metabolism will be measured   "
253578|NCT01174589|"     The primary purpose of this study is to illustrate whether there is a difference in the 6     minutes walking test in patients with hip fractures who have received 6 vs. 12 weeks of     physical training after discharge from hospital.   "
253579|NCT01174602|"     Exposure and response prevention (AN-EXRP) will help individuals with anorexia nervosa     improve their eating behavior.   "
253458|NCT01167504|"     The aim of this study is to determine how different ingredients which are found in food and     other consumer products affect the ability of saliva to form surface films.      Saliva forms a protective film on the surfaces inside the mouth. This film affects the way we     consume and digest food and protects our teeth and other surfaces inside the mouth from     disease and decay. It is not well known how this film forms, or which components in everyday     life affect formation of the film, and therefore its protective properties.      Samples of saliva will be collected from apparently healthy volunteers. The properties of the     film (thickness, density, strength, protein composition) will be studied in the laboratory     under controlled conditions. The effects of common ingredients in foods and other products     such as proteins, emulsifiers, preservatives and surfactants on the formation and properties     of the film will be determined.      The results of this study will help us to understand how different ingredients can change the     properties of saliva that may affect the way that we sense and digest food, and the ability     of saliva to protect against decay and infection. This could, in the future lead to new ideas     for developing:healthy foods (e.g. lower fat) that taste better, or more effective dental     care products.   "
253459|NCT01167517|"     This study will test the effectiveness of breast milk expression discharge instructions in     digital video disc (DVD) format for home use by mothers of very low birth weight infants on     the dose and duration of mother's breast milk feeding in their infants compared to breast     milk expression discharge instructions in printed format. The investigators hypothesize that     infants whose mothers receive breast milk expression discharge instructions via DVD will     receive a larger dose of maternal breast milk and for longer duration during the initial     neonatal intensive care unit hospitalization than infants whose mothers receive discharge     instructions in printed format.   "
253460|NCT01167530|"     The phase 1 study evaluats RAD001 in combination with radiotherapy in non-small cell lung     cancer.      First phase of the study:RAD001 (everolimus) will be administered per os every Monday, one     week before then during the radiotherapy and will be continued for 3.5 weeks after the end of     the radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three     patient cohorts are planned, receiving 10, 20 and 50 mg of RAD001 per week.Second phase of     the study:RAD001 (everolimus) will be administered per os every day one week before then     during the radiotherapy and will be continued for 3.5 weeks after the end of radiotherapy.     Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are     planned, receiving 2.5, 5 and 10 mg of RAD001 per day.The two phases of the study may be     conducted independently and in parallel.Radiotherapy: 66 Grays over 6.5 weeks. (5 weekly     fractions of 2 Grays)Chemotherapy: 2 cycles: Cisplatin 100 mg/m2 D1, Navelbine 25 mg/m2 D1,     D8, every 21 days.   "
253461|NCT01167543|"     This study investigates the prevalence and pathophysiology of dental and periodontal     involvement in pediatric patients with symptomatic or asymptomatic gastroesophageal reflux     (GER) or gastroesophageal reflux disease (GERD). Primary objectives are to compare the     prevalence of oral disease in children with and without a diagnosis or symptoms/signs of GERD     in a cross-sectional study. Secondary objectives are to examine factors that might lead to     the pathogenesis of the dental and periodontal lesions observed in this group of subjects.      The primary hypothesis is to prove that children aged 10-18 years diagnosed with or having     symptoms or signs of GERD have a significantly higher amount of dental erosions in comparison     to a matched control group.      Secondary hypotheses are that children aged 10 - 18 years diagnosed with or having signs of     GER have higher DMFS (Decayed, Missing, Filled permanent tooth Surfaces) rates, higher SBI     (Sulcus Bleeding Index) rates, worse Periodontal status, and lower saliva buffering capacity.   "
253462|NCT01167556|"     Cannabis use by people with schizophrenia is associated with family distress and poor     clinical outcomes. Therefore, an Family Motivational Intervention (FMI) was developed to help     parents to motivate their child with a diagnoses of recent-onset schizophrenia to reduce     cannabis use.      In a single-blind randomised clinical trail with 75 patients with the diagnosis of     schizophrenia, parents will be assigned to either FMI or to routine care. Assessments will be     conducted at baseline and at a 10- and 22-month follow-up. The study hypothesis is that FMI     will be more effective than routine care in reducing (a) cannabis use in patients and (b)     distress and sense of burden in parents.   "
253463|NCT01167569|"     It has been shown that the stress that occurs during cardiac surgery leads to early decrease     of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to     complications after surgery.      This study will investigate the effects of high doses of intravenous (IV) Vitamin C on the     outcome and complications after cardiac surgery.   "
253464|NCT01167582|"     The purpose of this study is to evaluate two approaches to red blood cell transfusion in     anemic patients with acute coronary syndrome.   "
253465|NCT01167595|"     Critically ill patients are consistently underfed. Feeding protocols are standardized system     tools used to guide nutrition practices, but to date have failed to improve delivery of     nutrition. The PEP uP Protocol is a new enhanced feeding protocol. Twenty North American     Intensive Care Units (ICUs) will assess baseline nutrition practices. Ten ICUs will be     randomized to implement the PEP uP Protocol and educational intervention, and ten will be     randomized to continue usual care. Nutrition practices will be reevaluated 6 months after     baseline. The investigators hypothesize that the PEP uP Protocol will increase delivery of     nutrition, and may ultimately lead to improved survival of critical illness.   "
253486|NCT01173276|"     This study aims to assess the feasibility of a novel standard of care technique for     intrauterine insemination (IUI) in HIV-discordant couples in the United States. This study     will involve couples in which the male partner is HIV positive, but the female partner is     negative. The investigators will institute a protocol similar to those used presently     throughout Europe with good success. To date, no HIV seroconversions have occurred in over     4000 inseminations performed in HIV serodiscordant couples. All male subjects will be on     stable HAART, and have undetectable serum viral loads prior to insemination. Semen samples     will be subjected to a stringent sperm wash procedure and screened for HIV RNA. Female     subjects will be followed post-insemination for seroconversion and pregnancy. Infants will be     followed for seroconversion at birth through 4 months of age.   "
253608|NCT01174992|"     The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an     adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight     closure.   "
253466|NCT01167608|"     Parkinson's disease (PD) is the second most common neurodegenerative disorder in the elderly.     In most people, the illness is complicated by co-occurring psychiatric problems such as     depression and anxiety. These non-motor concerns negatively affect the course and management     of the disease, often leading to poor outcomes for both patients and their families. Despite     these deleterious consequences, psychiatric symptoms in PD are both underreported by patients     as well as under-recognized and under-treated by health care providers.      The primary purpose of this study is to identify and describe barriers to mental healthcare     utilization for people with Parkinson's disease. Secondary objectives include the assessment     of attitudes and preferences regarding the need for mental health services in the PD     community and the acceptability of telehealth interventions as a method for improving access     and quality of care. In order to accomplish these aims, participants will be asked to fill     out an anonymous survey which will take about 15-30 minutes to complete. To best accommodate     PD patients with varying levels of disability, participants will have the option to complete     the survey online, on paper, or over the phone. The information obtained from this study will     be used to support future treatment development efforts (i.e., phone and internet based     interventions, community based trainings with local providers) intended to improve access and     quality of mental health care for people with PD. To the best of the investigators knowledge,     this is the first study to systematically examine barriers to mental healthcare utilization     in PD in a national sample.   "
253467|NCT01167621|"     The study is intended to evaluate the hemodynamic and the indexed extrapulmonary lung water     (ELWI) changes in patients treated by high frequency oscillation-ventilation (HFO-V) for     refractory acute respiratory distress syndrome (ARDS). HFO-V may be used as rescue treatment     in refractory ARDS but its hemodynamic impact is discussed. Moreover, as Extra Vascular Lung     Water (a transpulmonary thermodilution parameter) was proven to be an independent mortality     factor in ICU-patients, the investigators decided to monitor it in all ARDS patients who     ended up needing HFO-V, from HFO-V plugging under 72 hours of this type of ventilation. All     ARDS patients underwent high Positive End Expiratory Pressure (PEEP) with protective     ventilation and those who remained below a PaO2/FiO2 ratio of 120 after 24h will be     considered as refractory ARDS patients and, therefore eligible. They will be monitored by     the transpulmonary thermodilution PiCCO technique (Pulsion Medical System. Munich, Germany)     and placed under HFO-V. Both transpulmonary thermodilution measurements (ELWI , Cardiac     Output, Global End-diastolic Volume) and standard transthoracic echocardiographic     measurements (Ejection Fraction, End-diastolic Right and Left Ventricular Area, preload     indexes) were be performed from HFO-V plugging to Day 3. The investigators suggest that ELWI     will be correlated to HFO-V responsiveness and that cardiac output will not change at the     HFO-V plugging, regardless of preload indexes variation. Inclusion will be proceeded over a 2     year period and, according to the population, the investigators expect about 50 eligible     patients.   "
253477|NCT01167751|"     One of the important reasons for human dying is Ischemic heart disease (IHD). The most reason     is coronary artery disease. Beside morbidity, IHD induce myocardial infarction and necrosis     which due to congestive heart failure.      One therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the     cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method     to prevent ventricular remodeling after acute myocardial infarction. Human and animal studies     have shown that stem cell trans plantation to myocardial infarcted zone can improve heart     contractile function.      The aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation     in patients with myocardial infarction.   "
253468|NCT01167634|"     This is a 4-arm, randomized controlled trial to evaluate the effectiveness of financial     incentives to motivate and sustain long-term weight loss. The study will recruit eligible     employees at a large health management company to participate in a 6-month weight loss     program and have weight measurements for an additional 3-month follow-up period. The primary     outcome measure in this randomized controlled trial will be pounds of weight lost. The     experimental groups will include variations of deposit contracts (participants put their own     money at risk, and lose that money if they fail to achieve their weight loss goal) and fixed     payments. The use of deposit contracts is a powerful mechanism for inducing behavior change     that is based on loss aversion, a psychological concept first described by Nobel Prize winner     Daniel Kahneman and Amos Tversky in 1979. A deposit contract takes advantage of the fact that     people typically feel the pain of a loss more than the pleasure of a gain, increasing ones     motivation to reach a goal.      The study hypotheses are 1) mean weight loss will be greater in all intervention groups     compared to the control group by the end of 24 weeks; and 2) individuals in the intervention     groups will have a lower mean weight at the end of the 3-month follow-up period than     individuals in the control group.   "
253469|NCT01167647|"     Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when     infections including tuberculosis (TB) are not strongly suspected. However, the value of this     practice has been poorly defined.   "
253470|NCT01167660|"     The purpose of this study is to assess the reliability of a new non-invasive device to assess     the blood coagulation status among term and preterm babies.   "
253471|NCT01167673|"     Irritable bowel syndrome (IBS) causes many symptoms, including abdominal pain, irregular     bowel movements and bloating. It may be caused by loe degree inflammation of the intestine.     The ingredients of coltect which contains green tea, selenium, and curcumin have been proven     very safe and have anti inflammatory and anti oxidant activity. The aim of the study is to     see whether the use of Coltect can improve symptoms in IBS patients.   "
253487|NCT01173289|"     The primary objective of this study is to estimate the 5 year locoregional control rate after     External Beam Radiotherapy (EBRT) in the patient with locally advanced differentiated thyroid     cancer. In a prior retrospective trial for this same group of patients, the 5 year     locoregional control rate was 85% in EBRT group and 70% in no EBRT group. For the total     number of patients to detect a minimum of 20% improvement in 5 year locoregional control rate     with 80% of statistical power and the 5% significance level, the table for sample size     planning given by Makuch and Simon was chosen. Forty-three patients are required for this     regimen to regard as worthy of further investigation. Considering 15% follow up loss, 50     eligible patients will be enrolled.   "
253472|NCT01167686|"     General:Prospective, randomized, double blind controlled trial of the food supplement     GOLDTRAIN PLUS, to assess its safety and efficacy in comparison to placebo in subjects with     upper respiratory infection.      Hypothesis: The food supplement GOLDTRAIN PLUS will be superior to placebo in shortening the     time to recovery from the disease symptoms.      Study design and outcome measures:Study population of 182 generally healthy subjects with     acute respiratory infection randomized in 1:1 ratio to active supplement versus placebo     treatment, with randomization stratified by site. The study supplement administration will be     continued for 7 days, and patient global assessment (PGA) will be the main primary     measurement tool, based on a self-reporting questionnaire filled and monitored every 12 hours     for 7 consecutive days. Throat and nasal swabs determining type of viral infection, will be     taken at inclusion of patient and a number of blood tests at the end of treatment to look for     any adverse effects of the medication.      Analysis and conclusion: All data-from the filled questionnaires, clinical follow up and     laboratory studies will be analyzed by multivariate analysis to determine the efficacy of the     supplement and its correlation to the clinical and laboratory parameters.   "
253473|NCT01167699|"     The main objective of the study is to evaluate the patient preference for pain treatment with     respect to quality of life in patients with moderate to severe non malignant pain. Patients     who have insufficient pain relief and/or unacceptable side effects with the previous     analgesic treatment WHO step 1 or 2 and require around-the-clock opioid therapy can be     included in the study. The WHO step I or II analgesics will be compared with the new study     medication OXN (oxycodone/naloxone).   "
253474|NCT01167712|"     This phase III clinical trial studies two different dose schedules of paclitaxel to see how     well they work in combination with carboplatin with or without bevacizumab in treating     patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or     fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Bevacizumab is a type of drug called     a monoclonal antibody and blocks tumor growth by stopping the growth of blood vessels that     tumors need to grow. It is not yet known whether giving paclitaxel with combination     chemotherapy once every three weeks is more effective than giving paclitaxel once a week in     treating patients with ovarian, primary peritoneal, or fallopian tube cancer.   "
253475|NCT01167725|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Heating mitomycin C to     several degrees above normal body temperature and infusing it into the area around the tumor     may kill more tumor cells. Giving mitomycin C after surgery may kill any remaining tumor     cells. It is not yet known whether standard therapy is more effective with or without surgery     followed by mitomycin C.      PURPOSE: This randomized phase III trial is studying standard therapy with or without surgery     and mitomycin C in treating patients with advanced limited peritoneal dissemination of colon     cancer   "
253476|NCT01167738|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) may kill more tumor cells. Metformin hydrochloride may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not     yet known if combination chemotherapy is more effective with or without metformin     hydrochloride in treating patients with metastatic pancreatic cancer.      PURPOSE: This randomized phase II trial is studying giving cisplatin, epirubicin     hydrochloride, capecitabine, and gemcitabine hydrochloride together with metformin     hydrochloride to see how well it works compared to cisplatin, epirubicin hydrochloride,     capecitabine, and gemcitabine hydrochloride alone in treating patients with metastatic     pancreatic cancer.   "
253478|NCT01167764|"     Hemoptysis is one of the serious complication of many pulmonary diseases. Upto now, there is     no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a     randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of     hemoptysis.   "
253479|NCT01167777|"     Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification     assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia     trachomatis (CT) and Neisseria gonorrhoeae (GC).   "
253480|NCT01167790|"     Diagnosis of oral squamous cell carcinoma is always too late. Due to this delay for     diagnosis, prognosis is very bad. It has been demonstrate that systematic oral examination     decrease mortality in tobacco and alcohol consumers population (Sankaranarayanan and al.     Lancet 2005, 4, 1927-1933 ). An other study has demonstrate that autofluorescence is a useful     technic for detection of dysplasia and squamous cell carcinoma that cannot be seen with     conventional oral examination((Poh CF Wink Cancer Res on 2006 ( 22 ): 6616-22; Poh CF Head     Neck 2007 ( 1 ) 7 71-6).However autofluorescence has never been evaluated has a screening     tool for systematic oral examination and the reproductibility has never been studied.   "
253481|NCT01167803|"     Obesity is increasing in France, resulting in an increased demand for bariatric surgery.     However obesity also alters physiopathological pathways and the pharmacokinetics of     anesthestic agents. The investigators objective is to compare, among morbidly obese patients,     the immediate and intermediary emergence kinetics after balanced anesthesia using     remifentanil associated either with desflurane (reference arm) or with xenon (experimental     arm).   "
253482|NCT01167816|"     The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and     gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to     determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.   "
253483|NCT01167829|"     The purpose of this study is to test how the body absorbs a new form of oral testosterone     (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at     the University of Washington to monitor blood testosterone levels over a 24-hour period.   "
253484|NCT01167842|"     This study will analyze tumor tissue from patients with known genetic mutations (BRCA1,     BRCA2, CHK2, etc) who have tumor tissue available from two surgeries, either     primary/recurrent, or two different anatomical sites.   "
253485|NCT01173263|"     Eligible patients will be allocated to receive propofol sedation titrated to 3 different     Bispectral Index (BIS) levels in a random order. Primary hypothesis: Deepening propofol     sedation — as determined by BIS — lowers esophageal pressure in critical care patients.   "
253488|NCT01173302|"     This study is to investigate the persistence of rabies Chinese manufactured antibody 1-5     years after the post-exposure prophylaxis with vero cell antirabies vaccine and antibody     response to a single booster dose. A total of 160 subjects would be enrolled. These subjects     were all administered ChengDa antirabies vaccine from 2005 to 2009. After informed consent is     obtained, these subjects would be tested for their antirabies antibody titer and given a     single booster dose. Seven and 14 days later, the investigators would re-evaluate the     antibody titer.   "
253489|NCT01173315|"     The combination of vitamin and mineral supplementation may improve:        -  glycemic control        -  lipid profile        -  oxidative stress        -  blood pressure        -  nephropathy indices        -  neuropathy indices   "
253490|NCT01173328|"     Pursed-lip breathing (PLB) has been advocated to reduce respiratory rate and improve oxygen     saturation in patients with chronic obstructive pulmonary disease (COPD) at rest. Although     PLB is a strategy that potentially reduces expiratory flow limitation, there are only few     studies addressing its effects on exercise.      This study aimed to assess the ability of PLB to change the breathing pattern, degree of     dynamic hyperinflation (DH) and arterial oxygenation in COPD patients during exercise.     Exercise tolerance was evaluated by endurance time and respiratory mechanics was evaluated by     forced oscillation technique.   "
253491|NCT01173341|"     The objective of this study is to define the clinical significance of the Neuregulin/ErbB     signaling pathway and novel echocardiographic measures of cardiac function in predicting     incident risk of chemotherapy cardiotoxicity.   "
253492|NCT01173354|"     Weight loss commonly occurs in patients with chronic obstructive pulmonary disease (COPD),     negatively influencing their quality of life, treatment response and survival. Loss of muscle     protein is generally a central component of weight loss in COPD patients. Attempts to reverse     muscle loss in COPD by supplying large amounts of protein or calories to these patients have     been unsuccessful. Gains in muscle mass are difficult to achieve in COPD unless specific     metabolic abnormalities are targeted. The investigators recently observed that alterations in     protein metabolism are present in normal weight COPD patients. Elevated levels of protein     synthesis and breakdown rates were found in this COPD group indicating that alterations are     already present before muscle wasting occurs. Furthermore, reduced plasma essential amino     acid (EAA) levels were observed in COPD patients. These reduced EAA plasma levels were     significantly related with the presence of muscle wasting in COPD. Until now, limited     research has been done examining protein metabolism and the response to feeding in patients     with COPD. Previous studies support the concept of essential amino acids (EAA) as an anabolic     stimulus in the young and elderly and in insulin resistant states. Until yet no information     is present on the anabolic effects of EAA in elderly COPD patients.      It is therefore our hypothesis that a high-leucine essential amino acids mixture specifically     designed to stimulate protein anabolism will target the metabolic alterations of COPD     patients. In the present study, the acute effects of an EAA nutritional supplement on whole     body, muscle and liver protein metabolism will be examined in COPD patients and compared to a     supplement consisting of a balanced mixture of total amino acids. The principal endpoints     will be the extent of stimulation of whole body protein synthesis as this is the principal     mechanism by which either amino acid or protein intake causes muscle anabolism, and the     reduction in endogenous protein breakdown. Both endpoints will be assessed by isotope     methodology which is thought to be the reference method.   "
253494|NCT01173380|"     The investigators hope to learn about the effects of soy nuts on markers of health. When some     people eat soy foods, their gut bacteria make equol. Equol is a soy metabolite (small     molecule made during metabolism). The investigators will be testing blood samples to     determine if markers of health are different for people who make equol versus people who do     not make equol.   "
253495|NCT01173393|"     That paramedic core cooling during CPR using a rapid infusion of ice-cold (4 degrees C)     large-volume (30mL/kg) normal saline improves outcome at hospital discharge compared with     standard care in patients with out-of-hospital cardiac arrest.   "
253496|NCT01173406|"     The purpose of this study is to examine whether an education programme would enhance     continuous positive airway pressure (CPAP) adherence.   "
253497|NCT01173419|"     This is a multi center, randomized, comparison study using two already cleared methods of     treatment of the great saphenous vein (GSV). The hypothesis to be tested is that the use of     the Venacure EVLT NeverTouch procedure is no worse than the RF ClosureFAST procedure for     treatment of the GSV. Evaluation of post operative pain and bruising, quality of life     assessments, adverse event assessments, confirmation of long term GSV closure, use of     medications are criteria that will be evaluated during the course of this study.   "
253498|NCT01173432|"     Adipocyte fatty acid binding protein (A-FABP) is a member of the FABP super family, is     abundant in adipocytes and macrophages. Regulatory functions of A-FABP in lipid and glucose     metabolism have been described, and it is suggested to play an important role in the     pathogenesis of metabolic syndrome.We hypothesize that obstructive sleep apnea (OSA) may     upregulate A-FABP production and thus causally contribute to metabolic dysfunction. Our group     has recently demonstrated that A-FABP, expressed and secreted from adipocytes, is present in     the blood stream .The levels of A-FABP correlated with various metabolic variates in the     metabolic syndrome. Furthermore, we have obtained novel data in men with a range of sleep     disordered breathing showed that the duration of oxygen desaturation correlated with     circulating levels of A-FABP, independent of age and waist/body mass index. The current     proposal aims to pursue this finding and further explore the role of A-FABP in the     association of OSA and metabolic dysfunction.   "
253499|NCT01173445|"     The purpose of this study is to see if researchers can detect circulating tumor cells (CTC)     and circulating endothelial cells (CEC) in the blood.   "
253500|NCT01173458|"     The purpose of this study is to determine whether or not CTCs can be detected in blood     samples taken from patients diagnosed with small cell lung cancer. The purpose is to compare     CTC analysis to tumor samples to look for differences.   "
253501|NCT01173471|"     The purpose of this study is to evaluate the efficacy of systemically administered AZD4017,     compared with placebo, over a 28-day period in patients with raised intra-ocular pressure     (IOP).   "
253502|NCT01173484|"     The diagnosis of gastroparesis suggests that delayed gastric emptying is the underlying     cause of symptoms, but this description fails to explain the variable presentation. There are     fundamental differences in causes, symptoms, and prognosis among patients with idiopathic     gastroparesis. Understanding these differences is necessary in order to provide effective     treatment in these patients. We believe our classification for gastroparesis is a useful tool     in the management of patients with idiopathic gastroparesis to predict clinical severity,     treatment response, and future prognosis.   "
253532|NCT01173991|"     The investigators postulate that carbohydrate (CHO) counting in adult patients with type 1     diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) may     improve glycemic control, glycemic variability and quality of life.   "
253503|NCT01173497|"     The purpose of the study is to investigate the response rate for triple negative breast     cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan.      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
253504|NCT01173510|"     Human Immunodeficiency Virus (HIV) infection is permanently established by integrating a     deoxyribonucleic acid (DNA) copy into the human chromosome, a step also necessary to complete     the Human Immunodeficiency Virus (HIV)replication cycle. Standard treatment of HIV infection     suppresses Human Immunodeficiency Virus (HIV)replication and has not been able to eliminate     Human Immunodeficiency Virus (HIV)from an infected person because of the integrated Human     Immunodeficiency Virus (HIV). Raltegravir (RAL), the first approved antiretroviral (ARV) in a     new class called integrase inhibitors, works by preventing integration of Human     Immunodeficiency Virus (HIV). For participants with Human Immunodeficiency Virus (HIV)who     have never taken antiretroviral medications, this research study will test whether     Raltegravir (RAL), a recommended first-line ARV, can eliminate Human Immunodeficiency Virus     (HIV)from key immune system cells.   "
253520|NCT01173835|"     The purpose of this study is to design an incentive-based intervention to motivate a     tobacco-free lifestyle among high school students and to pilot the intervention in the first     academic year in two schools (CT and NY) and examine feasibility and acceptability.     Preliminary efficacy of the intervention will be assessed by implementing it in two new     schools (CT and NY) in the second academic year and determine an effect size estimate for a     larger trial.      The study is intended to assess the number of students joining the program and pledging to be     smoke-free and to examine changes in tobacco use rates and attitudes following intervention     exposure. We hypothesize that the schools will have lower rates of tobacco use and     improvement in attitudes, norms and behavioral control over tobacco use after participating     in the program.   "
253521|NCT01173848|"     The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in     raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney     disease who are not on dialysis.   "
253522|NCT01173861|"     Purpose: Examine the effectiveness of cancer center-based physical activity counseling on     physical activity rates and quality of life in breast cancer survivors.      Hypothesis: Participants in the intervention group will indicate greater step counts and     quality of life at the end of the intervention compared to the control group   "
253505|NCT01173523|"     Small cell lung cancer (SCLC) is a chemotherapy and radiotherapy sensitive tumor, but with     very high rates of relapse and metastasis, resulting in a very poor outcome. Among     limited-stage patients, the relapse rate is at least 80% and among extensive-stage patients,     the relapse rate is 95-98%. The impetus to develop more effective therapies against novel     targets in SCLC is therefore high.      Hsp-90 inhibitors are a new class of drugs with important anti-malignant potential in a     variety of tumor types because of the reliance of multiple oncoproteins on Hsp90 function.     Although small cell neuroendocrine tumors generally carry many mutated oncoproteins, without     clearly defined clients for Hsp90 mediating inhibitor effects in these cells, a recent study     demonstrated that Hsp90 inhibition causes massive apoptosis by activating the intrinsic     apoptotic pathway in a number of SCLC cell lines. SCLC is a particularly attractive target     for apoptosis inducing drugs because of high growth rates and evidence of molecular     alterations affecting apoptotic mechanisms.      STA-9090 is a novel, small-molecule inhibitor of Hsp90. Unlike earlier generations of Hsp90     inhibitors, STA-9090 has been shown to be a potent inducer of apoptosis in a variety of cell     lines and has anti-tumor activity in multiple types of human xenografts. As was seen with     other Hsp90 inhibitors, STA-9090 also induces apoptosis in a number of SCLC cell lines.      Based on the anti-tumor potential seen pre-clinically with Hsp90 inhibition, the potent     effects of STA-9090 seen pre-clinically as compared with other inhibitors in the same class,     as well as early data suggesting safety and tolerability of this drug in the Phase I setting,     we propose to study the single-agent activity of STA-9090 in a Phase II trial of patients     with relapsed or refractory small cell lung cancer.   "
253506|NCT01173536|"     This is a Phase I, single-center, three-arm, randomized, double-blind, active- and     placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in     healthy female subjects of non-childbearing potential.   "
253507|NCT01173549|"     The purpose of this study is to evaluate the effect of canagliflozin on gastrointestinal     glucose absorption in healthy volunteers.   "
253508|NCT01173562|"     The purpose of this study is to assess the safety and tolerability of mebendazole 500-mg     chewable tablet formulation in a pediatric population. Mebendazole is a drug used for the     treatment of soil-transmitted parasitic helminth (STH) (ie, parasitic worm) infections such     as pinworm, whipworm, common roundworm, common hookworm, and American hookworm.   "
253509|NCT01173575|"     This project aims to assess the clinical and microbiological efficacy of fosfomycin(FOM) in     patients with bacterial infection.      Primary objective:      • To assess clinical and microbiological efficacy of FOM in patients with bacterial     infection.      Secondary objectives:        -  To determine the rate and severity of unexpected adverse events.        -  To determine the mean duration of therapy with FOM in patients with bacterial infection.      Study design:      Multi-center, non-interventional study   "
253510|NCT01173588|"     The aim of this study was to evaluate the effect of the consumption of yogurt added with     bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A product as     herein described is expected to improve gastrointestinal function and maintain the intestinal     microflora balance of healthy subjects and perhaps of patients with altered bowel functions.   "
253533|NCT01174004|"     The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin     compared to placebo in patients with Parkinson's disease psychosis (PDP).   "
253511|NCT01173718|"     This study is a prospective, non-randomized, multi-center evaluation of the performance of     the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease     (ESRD), who are either currently receiving or expected to require hemodialysis through a     prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month     cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other     arteriovenous grafts (AVGs).      >      >      >      >      >      > A total of 138 Subjects will be enrolled. Once the study procedure has been successfully     completed, cannulation may occur at any time at the Investigator's discretion.      >      >      >      >      >      > Subjects will be selected from up to 20 Investigational Sites.   "
253512|NCT01173731|"     The purpose of this study is to generate long-term safety, tolerability and efficacy data for     AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID     (Parkinson's disease, L-dopa induced dyskinesias).   "
253513|NCT01173744|"     The objective of the study is to examine the treatment of unstable Intertrochanteric     fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS).      This is a prospective study. Sixty patients with unstable Intertrochanteric fractures will be     randomized to be treated using either Gamma nail or DHS. The patients will be followed for 12     months. The primary endpoint is the clinical outcome as measured by the Merle d'Aubigne and     Postelhip score.   "
253514|NCT01173757|"     The purpose of this study is to evaluate the relationship between plasma drug levels and     receptor binding in brain using PET; and to evaluate safety and tolerability after a single     administration of PF-04995274 in healthy volunteers.   "
253515|NCT01173770|"     This is a First-In-Man study designed to examine the safety, tolerability, pharmacokinetics     and functional activity of ADC3680B after single and multiple doses in healthy male     volunteers.   "
253516|NCT01173783|"     It is the aim of this register to document the development of therapies by implantation of     Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.   "
253517|NCT01173796|"     This prospective, randomized study aims to compare the impact of ablation of perimitral     flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of     additional triggers, on procedure outcome.   "
253518|NCT01173809|"     This prospective randomized study aims to investigate the effect of continuous versus     interrupted use of Amiodarone on the procedure outcome in long-standing persistent (LSP)     atrial fibrillation patients undergoing pulmonary vein antral isolation (PVAI).   "
253519|NCT01173822|"     The study is an randomized controlled trial (RCT) of 198 coronary artery bypass graft (CABG)     patients, exploring whether ultrafiltration of residual blood in the cardiopulmonary bypass     circuit reduces transfusion and bleeding.   "
253523|NCT01173874|"     The investigators hypothesize that cognitive remediation will be superior to the active     control group on the change from baseline to study end point of cognitive remediation phase     on both co-primary outcome measures (standardized composite MATRICS score and Cognitive     Assessment Interview).   "
253524|NCT01173887|"     This is a multicenter, randomized, open-label, parallel-group study to compare mLSG15 +     KW-0761 to mLSG15 in subjects with CCR4-positive adult T-cell leukemia-lymphoma (untreated     primary disease). The primary variable is an efficacy of KW-0761 used as an add-on therapy to     mLSG15 as measured in terms of complete response rate (CR/CRu) in the best overall response     assessment for antitumor effect. The secondary variables include response rate (CR/CRu/PR) in     the best overall response assessment for antitumor effect, complete or response rates by     lesion site in the best overall response assessment for antitumor effect, progression-free     survival and overall survival. The safety and pharmacokinetic profiles of KW-0761 will be     also determined.   "
253525|NCT01173900|"     The aims of this study are:        1. To determine feasibility of a school-based human papillomavirus (HPV) vaccination          programme in Tanzania.        2. To measure the uptake and acceptability of two different vaccination strategies in rural          and urban schools.        3. To examine the characteristics of accepters/refusers of vaccination and to identify          reasons for acceptance, refusal or non-completion.        4. To measure the cost of implementing a school-based HPV vaccination programme in          Tanzania.   "
253526|NCT01173913|"     Oral administration has many advantages above intravenously administrated drugs for patients.     Up to now, oral administration of docetaxel as single agent has not been feasible due to low     and variable bioavailability. This low systematic exposure to docetaxel can effectively be     increased after co-administration of ritonavir. The department of pharmacy of the Slotervaart     Hospital and Netherlands Cancer Institute developed a solid oral dosage form for docetaxel,     ModraDoc001 10 mg capsules.      Two other novel dosage forms of docetaxel with improved pharmaceutical characteristics, have     been developed: ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets. The systemic     exposure after administration of those forms is now being investigated.   "
253527|NCT01173926|"     This trial is conducted in Europe. The aim of this trial is to compare the blood     glucose-lowering effect of NN5401 (insulin degludec/insulin aspart, IDegAsp) with NN1250     (insulin degludec, IDeg) and insulin aspart (IAsp) in subjects with type 1 diabetes mellitus.   "
253528|NCT01173939|"     The study is being conducted to compare the effect of standard treatment (target LDL-C level:     <120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: <70 mg/dL)     in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients     with concomitant type 2 diabetes and hypertension.   "
253529|NCT01173952|"     This study is prospective evaluation of quality of life in men undergoing robotic assisted     laparoscopic radical prostatectomy versus radical retropubic prostatectomy.   "
253530|NCT01173965|"     Endometrial ablation in women with dysfunctional uterine bleeding using second generation     ablation devices is a common widespread therapeutic approach. This study aims to prove that     amenorrhoea rates using Novasure are higher than those observed in microwave endometrial     ablation, one year following intervention.   "
253531|NCT01173978|"     The incretin effect in patients with type two diabetes is reduced. The investigators have     previously shown that it is possible to induce a defect in the incretin effect in healthy     individuals. The purpose of this study is to evaluate the insulinotropic affect of the     incretin hormones in healthy individuals before and after a deterioration of the glucose     homeostasis.   "
253534|NCT01174017|"     This study compares the ability of a new design of brachytherapy seed for prostate seed     implants for treatment of prostate cancer to maintain their intended position in the prostate     after being deposited. Standard seeds, especially in apical locations, have a tendency to     migrate distally in response to muscular forces. AnchorSeeds have a textured coating which is     designed to prevent migration. 40 patients who are eligible and suitable for prostate     brachytherapy will be randomly assigned to receive either standard seeds or AnchorSeeds.   "
253535|NCT01174030|"     The purpose of this vehicle controlled study is to evaluate the efficacy and safety of     CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18%     applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate     to severe facial erythema associated with rosacea.   "
253536|NCT01174043|"     This research study is looking for patients with newly diagnosed acute myeloid leukemia     (AML), AML that has returned (relapsed), or it has not responded adequately to previous     treatments. Treating certain patients with chemotherapy may not be to their benefit or may     cause more harm than benefit. The purpose of this study is to find out what effects (good and     bad) erlotinib has on patients and their AML.   "
253537|NCT01174056|"     The purpose of this research study is to gain understanding of the basic responses of the     lung to inflammation and specifically if a certain medication can reduce the inflammation     alone or in combination with another. Inflammation is the way our bodies react to irritation     or injury, and involves red, warm, and often painful swelling of the affected tissue. Acute     lung injury involves inflammation that is not specific to one area of the lung and is caused     by any one of several conditions: infection, trauma, breathing toxic substances, etc. When     lung injury is severe, not enough oxygen can get into the body; this can lead to the need for     mechanical support of breathing (mechanical ventilation), problems with brain, heart or other     organ function, and in some cases, death.   "
253538|NCT01174069|"     Hypothesis: Natural orifice transgastric cholecystectomy with laparoscopic assist will be     feasible and have comparable complication rates as standard lap cholecystectomy. Patient     benefits will include less pain and scaring.   "
253539|NCT01174082|"     The goal of this clinical research study is to learn if vaccinating a donor with your     purified myeloma protein and then injecting it back into you will help your immune system     control the multiple myeloma.   "
253565|NCT01174420|"     The aim of this prospective randomized study is to investigate the efficacy and safety of     trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in     patients with medically uncontrolled open angle glaucoma.   "
253540|NCT01174095|"     The primary aim of the study is to assess and follow-up subjects that received     AdGVVEGF121cDNA in IRB protocol #0794-894 entitled Phase I Study of Direct Administration of     a Replication Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to the     Ischemic Myocardium of Individuals with Diffuse Coronary Artery Disease and IRB protocol     #0297-693 entitled Phase I Study of Direct Administration of a Replication Deficient     Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to the Ischemic Myocardium of     Individuals with Diffuse Coronary Artery Disease Via Minimally Invasive Surgery.   "
253541|NCT01174108|"     Background:        -  Stem cell transplants from related donors (allogenic stem cell transplants) can be used          to treat individuals with certain kinds of severe blood diseases or cancers, such as          severe anemia. Allogenic stem cell transplants encourage the growth of new bone marrow          to replace that of the recipient. Because stem cell transplants can have serious          complications, researchers are interested in developing new approaches to stem cell          transplants that will reduce the likelihood of these complications.        -  By reducing the number of white blood cells included in the blood taken during the stem          cell collection process, and replacing them with a smaller amount of white blood cells          collected prior to stem cell donation, the stem cell transplant may be less likely to          cause severe complications for the recipient. Researchers are investigating whether          altering the stem cell transplant donation procedure in this manner will improve the          likelihood of a successful stem cell transplant with fewer complications.      Objectives:      - To evaluate a new method of stem cell transplantation that may reduce the possibly of     severe side effects or transplant rejection in the recipient.      Eligibility:        -  Recipient: Individuals between 4 and 80 years of age who have been diagnosed with a          blood disease that can be treated with allogenic stem cell transplants, and who have a          related donor to provide the stem cells.        -  Donor: Individuals between 4 and 80 years of age who are related to the recipient and          are eligible to donate blood.      Design:        -  All participants will be screened with a physical examination and medical history.        -  DONORS:        -  Donors will undergo an initial apheresis procedure to donate white blood cells.        -  After the initial donation, donors will receive injections of filgrastim to release bone          marrow cells into the blood.        -  After 5 days of filgrastim injections, donors will have apheresis again to donate stem          cells that are present in the blood.        -  RECIPIENTS:        -  Recipients will provide an initial donation of white blood cells to be used for research          purposes only.        -  From 7 days before the stem cell transplant, participants will be admitted to the          inpatient unit of the National Institutes of Health Clinical Center and will receive          regular doses of cyclophosphamide, fludarabine, and anti-thymocyte globulin to suppress          their immune system and prepare for the transplant.        -  After the initial chemotherapy, participants will receive the donated white blood cells          and stem cells as a single infusion.        -  After the stem cell and white blood cell transplant, participants will have regular          doses of cyclosporine and methotrexate to prevent rejection of the donor cells.          Participants will have three doses of methotrexate within the week after the transplant,          but will continue to take cyclosporine for up to 4 months after the transplant.        -  Participants will remain in inpatient care for up to 1 month after the transplant, and          will be followed with regular visits for up to 3 years with periodic visits thereafter          to evaluate the success of the transplant and any side effects.   "
253542|NCT01174121|"     Background:      The NCI Surgery Branch has developed an experimental therapy that involves taking white blood     cells from patients' tumors, growing them in the laboratory in large numbers, and then giving     the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL     and we have given this type of treatment to over 200 patients with melanoma. Researchers want     to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or     ovarian/endometrial cancers. In this study, we are selecting a specific subset of white blood     cells from the tumor that we think are the most effective in fighting tumors and will use     only these cells in making the tumor fighting cells.      Objective:      The purpose of this study is to see if these specifically selected tumor fighting cells can     cause digestive tract, urothelial, breast, or ovarian/endometrial tumors to shrink and to see     if this treatment is safe.      Eligibility:      - Adults age 18-70 with metastatic digestive tract, urothelial, breast, or     ovarian/endometrial cancer who have a tumor that can be safely removed.      Design:      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo     a history and physical examination, scans, x-rays, lab tests, and other tests as needed.      Surgery: If the patients meet all of the requirements for the study they will undergo surgery     to remove a tumor that can be used to grow the TIL product.      Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells.     {Leukapheresis is a common procedure, which removes only the white blood cells from the     patient.}      Treatment: Once their cells have grown, the patients will be admitted to the hospital for the     conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for     about 4 weeks for the treatment.      Follow up: Patients will return to the clinic for a physical exam, review of side effects,     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1     year as long as their tumors are shrinking. Follow up visits will take up to 2 days.   "
253543|NCT01174134|"     The clinical trial will provide a milk-based drink with constant amounts of nutrients but     differing amount of Docosahexaenoic Acid (DHA).   "
253544|NCT01174147|"     This study will evaluate the incidence rate of Candida blood stream infection (candidemia)     among people hospitalized in participating medical centers in Brazil, and will assess the     antifungal drug susceptibility patterns of Candida clinical isolates. No hypotheses will be     tested in the study. Candida blood stream isolates collected from people hospitalized for any     reason during the study period will be sent to a core mycology laboratory for antifungal drug     susceptibility testing. All people who develop candidemia while hospitalized will be     considered participants in the study.   "
253546|NCT01174173|"     The purpose of the study is to determine if the medication, ranolazine (study drug), can help     improve blood flow to your heart, increase your exercise capacity and improve your quality of     life (QOL). For this study, you will be asked to perform several tests in order to determine     if your heart function, exercise capacity, chest pain and QOL have improved after 3 months of     treatment with ranolazine. Ranolazine is approved by the U.S. Food and Drug Administration     (FDA) for the treatment of angina.   "
253547|NCT01174186|"     Studies with intestinally asymptomatic patients with spondyloarthritis showed that     approximately 1/3 had visible ulcers in the colon by scopic examinations and 2/3 had changes     detectable by microscopy. Only those patients who improved in arthritis symptoms showed     improvement in colonic changes. In these studies only colon and the terminal ileum was     examined. Inflammation of the small intestine was not examined. Newer studies have shown an     immunological link between Crohns disease and spondyloarthritis but not ulcerative colitis.     The investigators wish to examine the small intestine in these patients before and after     treatment, since they expect to find ulcers there linking spondyloarthritis to Crohns disease     and healing after treatment.   "
253548|NCT01174199|"     RATIONALE: Temsirolimus and vorinostat may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Giving temsirolimus together with vorinostat may kill     more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of     temsirolimus and vorinostat in treating patients with metastatic prostate cancer.   "
253549|NCT01174212|"     Subjects will be consented and then determined randomly whether they will receive antibiotics     prior to their surgery or during their surgery. Each patient will have cultures taken before     and during their surgery from the infected hip or knee. Results will be compared after     completion of the study.   "
253566|NCT01174433|"     To assess the safety and feasibility of the use of the Tryton bifurcation coronary stent     system for the treatment of single de novo bifurcation lesions in native coronary arteries.   "
253567|NCT01174446|"     The purpose of this pivotal Phase 1/3 study is to determine the pharmacokinetic (PK)     parameters, the hemostatic efficacy, and the safety of BAX 326, a recombinant factor IX, in     previously treated patients (PTPs) with severe and moderately severe hemophilia B.   "
253550|NCT01174225|"     The goal of this study is to provide better information about contraception to women having     an abortion so that they are less likely to have another unintended unwanted pregnancy.      Participating subjects will receive their choice of contraception following their abortion     and if this choice is an IUD they will be randomly assigned to one of two types of copper     intrauterine devices.      All participating women will fill out a survey about their contraceptive choices at the time     of their abortion as well as at 3, 6, and 12 months afterwards. The investigators will also     follow pregnancy rates at 1 through 5 years after the abortion to see which form of     contraception was most effective.      The investigators expect to find that IUDs are the most effective form of contraception but     that the types of copper IUDs currently available in Canada are not known to be as effective     as those available in other countries, for which high quality evidence is available. The     investigators hope to use this data to determine the effectiveness of copper IUDs available     in Canada.   "
253551|NCT01174238|"     This is a two arm prospective Phase II pilot trial designed to determine the optimal duration     of break between axitinib and chemotherapy with carboplatin/paclitaxel in melanoma. In this     study, 6 patients will be enrolled to Arm A, the FLT PET scan (3'deoxy-3'-18F-Fluorothymidine     positron emission tomography scans)cohort. 30 patients will be enrolled to Arm B, the     treatment-only cohort. 36 total patients will be enrolled. The treatment schedule will be the     same in either cohort, with the exception of the FLT PET scans.   "
253552|NCT01174251|"     Polymorphic ventricular tachycardia, known as Torsades de Pointes (TdP), is a specific form     of ventricular arrhythmia with a characteristic twist of the QRS complex around the     isoelectric baseline. TdP can degenerate into ventricular defibrillation followed by sudden     cardiac death. A predictor for the development of TdP is the length of the QT interval     measured on an EKG recording. The QT interval is known to be prolonged by many medications     used in a perioperative setting as well as by other conditions such as hypothermia and     electrolyte imbalance. General anesthesia exposes most of the investigators patients to a     combination of several of those medications and conditions and therefore might increase the     risk for the development of QT prolongation. Moreover, patient related risk factors are well     known and aggravate the individual risk for potential life threatening TdP events when     exposed to QT prolonging medications perioperatively.      Previous research suggests that more than 20% of the patients might develop QT prolongations     perioperatively and are consequently on an increased risk for TdP; yet, no study has     systematically investigated the magnitude of the problem and associated risk factors.      The proposed pilot study is designed as a prospective observational cohort study to     investigate the QT interval before, during and after general anesthesia. It aims to determine     the incidence of perioperative QT prolongations. A customary long term EKG recording device     will be connected to a random sample of patients undergoing general anesthesia. Using these     continuous EKG tracings, the lengths of the QT interval will be analyzed during the     perioperative period.   "
253553|NCT01174264|"     This randomized clinical trial studies the effect of food on the pharmacokinetics of     vismodegib. Studying the effects of meals on the absorption of vismodegib may help doctors     prescribe correct doses and label the drug accurately.   "
253554|NCT01174277|"     By doing this study, researchers hope to understand the many changes that occur in the blood     of people who have chronic GvHD. This may also help the researcher understand how ECP works     and help guide therapy for patients who have chronic GvHD in the future.   "
253555|NCT01174290|"     About one-third of the patients who develop mild, acute confusion (i.e., subsyndromal     delirium) will go on to develop a severe acute confusional state (i.e. delirium). Delirium     refers to a temporary change in the way a person thinks about things. Delirium occurs in     patients admitted to the hospital particularly those patients that are very sick, who are     given a number of medications, and who are not able to sleep normally. It affects their     behavior, their understanding of the people and things around them, and their ability to make     decisions. While ICU doctors do everything possible to eliminate the factors that may cause     delirium, delirium may cause a person to become very agitated which if not controlled is     dangerous to their safety as well as the safety of those around them. As well, if delirium     develops in patients in the ICU, it may increase the risk for death, keep patients in both     the ICU and hospital for longer and send patients to a long term care facility rather than     home after they are discharged from the hospital. A recent medical report found that patients     in the ICU who develop subsyndromal delirium have a mortality rate, a length of stay in both     the ICU and the hospital, and a transfer rate to a long term care facility that is nearly as     great as patients with delirium and greater than patients who develop neither subsyndromal     delirium or delirium. Recent studies in non-ICU patients suggest that if a patient who is at     high risk for developing delirium receives a medication called an antipsychotic (e.g.     haloperidol) they may not be as likely to develop delirium or if they do develop delirium it     will not last as long. No studies have evaluated the effect of administering an antipsychotic     in patients in the ICU who have subsyndromal delirium. Another study completed in the ICUs at     Tufts Medical Center found that there may be an association between the development of     delirium in patients with subsyndromal delirium and the use of haloperidol. However, this     small study had many limitations and thus it is not currently known whether using haloperidol     in patients with subsyndromal delirium will actually cause fewer of these patients to develop     delirium. Haloperidol makes a person sleepy and helps control behavior like agitation.     Haloperidol is the drug that is used most often to help control delirium in the ICU. This     prospective, double-blind, randomized controlled study will determine if haloperidol     administered through the vein four times daily (1mg IV q6h) to patients who have subsyndromal     delirium, and who are on a breathing machine and being cared for by the Medical ICU service     at Tufts Medical Center, will help prevent patients from developing delirium. A total of 68     participants will be enrolled. Exclusion criteria are extensive and include conditions that     could affect the ability to determine if delirium is present or increase the risk for side     effects related to the administration of haloperidol. Patients older than 80 will be excluded     from the study. Study medication (i.e. haloperidol) will be administered until one the     following occurs: 1) delirium develops (that is confirmed by a staff psychiatrist or his     designate, 2) the patient is discharged from the ICU at Tufts Medical Center, 3) the patient     has received haloperidol or placebo for 10 days or 4) an adverse event potentially     attributable to the study drug is experienced by a patient that is deemed, in the opinion of     a pulmonologist member of the investigative team to warrant discontinuation of therapy.     Haloperidol may cause unwanted side effects such as low blood pressure, twitching, and an     unsafe abnormal heart rhythm. Patients with chronic confusion (e.g., a dementia such as     Alzheimer's Disease) should not receive haloperidol and will not be included in this study.     Patients will be carefully monitored for side effects that are potentially related to     haloperidol. Patients who become confusion-free in the ICU before they leave the ICU (i.e.,     have no subsyndromal delirium) will be asked to provide consent for all research activities     that occured in the ICU. If patients where cognition is regained (ie. no subsyndromal     delirium or delirium) are not willing to provide consent then any study data collected from     them while they were in the ICU will be destroyed and they will not be approached to     participate in the post-ICU component of the study. This study also seeks to understand how     the use of haloperidol in the ICU in patients with subsyndromal delirium may have affect     memory, emotional status, happiness, ability to function, and quality of sleep in patients     after they leave the ICU. Patients (that do not have delirium based on CAM screening at the     time the 3-10 day and 6 month assessments are attempted) will be approached to participate in     this post-ICU component of the study.   "
253556|NCT01174303|"     This trial is conducted in Europe. The aim of this trial is to investigate the exposure of     NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1     diabetes mellitus.   "
253557|NCT01174316|"     The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive     ventilation (NIV) versus standard NIV in patients admitted to hospital with acute     exacerbation of chronic respiratory failure.      The investigators hypothesise that autotitrating NIV will ventilate patients with acute     exacerbations of chronic respiratory failure as effectively as standard NIV.   "
253561|NCT01174368|"     This is a clinical research study of an investigational (FDA IND-BB 10091) treatment of     subjects with castration-resistant prostate cancer resistant to Taxanes (docetaxel,     cabazitaxel) and evidence of disease progression on androgen-axis inhibition and/or     immunotherapy in the form of sipuleucel-T.      The treatment is being evaluated for its effect on tumor growth. It consists of the placement     (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA     macrobeads). The cells in the macrobeads produce substances that have been shown to slow or     stop the growth of tumors in experimental animals and veterinary patients. It has been tested     in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II     studies in patients with colorectal, pancreatic or prostate cancers are in progress.   "
253562|NCT01174381|"     This study attempts to implement a lifestyle intervention programme aimed at changing the     dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old     adults in the MOH area, Ragama and measure the effectiveness of the programme.   "
253563|NCT01174394|"     This is a randomized, assessor-blind, placebo controlled study in post stroke depression     patients. Subjects receiving antidepressant drug would be assigned to either active or     placebo scalp electro-acupuncture treatment, on the hypothesis that acupuncture intervention     combined with antidepressants could produce greater therapeutic effects than antidepressants     alone.   "
253564|NCT01174407|"     The purpose of this study is to determine a possible implication of CD21, CD35 and CD55 in     the pathogenesis of age-related macular degeneration. The aim is to asses a difference in     expression rates of these factors on AMD-patients and a healthy control group.   "
253570|NCT01174485|"     Liposuction is the most popular aesthetic surgery in Brasil and worldwide. Evidence showing     that adipose tissue is a metabolically active tissue led to the suggestion that liposuction     could be a viable method for the improvement of metabolic profile through the immediate loss     of adipose tissue. Studies about the effects of liposuction on metabolic profile are     conflicting. A few studies report the improvement of insulin sensitivity, inflammatory     markers and lipid profile, others observe no changes and a few report the worsening of     metabolic profile. In addition, animal studies show a compensatory growth of intact adipose     tissue in response to lipectomy. Physical exercise improves insulin sensitivity, lipid     profile, inflammatory balance, adipose tissue distribution and increases or preserves free     fat mass. Therefore, liposuction and physical exercise seem to act on similar tissues of the     body. To the investigators knowledge, there are no studies about the associated effects of     liposuction and exercise in humans. However, one can suggest that exercise training     associated with liposuction could: [1] attenuate or block the possible fat recovery or     compensatory growth; [2] block or reverse the possible harmful effects of liposuction; or [3]     exert an additive or synergistic effect to the possible beneficial effects induced by     liposuction on metabolic and hormonal profile and inflammatory balance.   "
253571|NCT01174498|"     The increased incidence of pain syndromes requires the investigation of pathophysiological     coherences as well as searching for new therapies. In the recent years neurostimulating     techniques have been a promising approach regarding their analgesic effect. Combined with     therapeutic standard procedures they can increase these effects and can have a positive     impact on co-morbid diseases. The stimulation of the vagus nerve was proved as an efficient     analgesic method in animal experiments and open clinical pilot studies amongst humans.     Despite the lack of controlled approaches applying the method against defined pain syndromes,     the stimulation of the vagus nerve has shown up as an effective method treating other     psychiatric diseases like depression. The processing of stress, which is involved directly     and indirectly in the pathogenesis of pain, seems to be susceptible for vagal stimulation.     Compared with invasive methods the transcutaneous stimulation offers obvious advantages     concerning appliance and occurrence of side effects. There are no studies so far dealing with     the neuromodulatory effect on the handling of pain or the clinical therapy of defined     (chronic) pain related diseases using the t-VNS system. The study hypothesis implies a change     of experiencing pain when applying the t-VNS in healthy subjects.   "
253572|NCT01174511|"     Atopic dermatitis (AD) is a chronic inflammatory skin disease, affecting 20% of all babies     and children around the world. Diagnosis of atopic dermatitis is clinical and depends on the     existence of at least two out of the four following criteria: itching, a chronic disease     course with exacerbations and remission ,rash with characteristic distribution and shape ,     atopia of the patient or family by history.      Initial treatment is based on keeping skin moist and avoiding a flare-provoking stimuli and     allergens. The research product A-1 COOL is a skin cream approved by the Israeli Ministry of     Health for cooling down of skin irritation. A-1 COOL is rich in herbal medicine ingredients     and does not contain steroids.A-1 COOL can be beneficial in Atopic Dermatitis patients due to     its following action mechanisms: sealing of the inflamed skin and retention of water,     prevention of the itching cycle by keeping the skin moist, disinfection of the skin by the     herbal ingredients.   "
253573|NCT01174524|"     The purpose of this study is to determine whether low-dose contraceptive pills are effective     in the improvement of quality of life in patients in the different phases of menacme.   "
253574|NCT01174537|"     Patients with specific metastatic cancers who failed prior therapeutic regimes will be     treated with NDV for at least a year or until disease progression. The study will measure     progression-free disease and posits that it will be extended.   "
253575|NCT01174550|"     A prospective multicenter imaging study for evaluation of chest pain. Objective is to     determine whether an initial non-invasive anatomic imaging strategy with coronary CT     angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for     coronary artery disease relative to an initial functional testing strategy (usual care).     Study hypothesis: initial anatomic testing strategy will provide information that will result     in superior long-term health outcomes as compared to an initial functional testing strategy.   "
253576|NCT01174563|"     This open-label, single arm study will assess the correlation between Tarceva     (erlotinib)-induced rash and efficacy in patients with inoperable, locally advanced,     recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for     advanced disease. Patients will receive Tarceva at a dose of 150 mg daily orally, with dose     adjustments according to protocol depending on toxicity. Anticipated time on study treatment     is until disease progression occurs.   "
253580|NCT01174615|"     The collection of Blood and/or Bone Marrow from patients with blood disorders, blood cell     malignancies and associated conditions will serve as a convenient and comprehensive source of     tissue to give us further information about the differences between normal blood cells and     blood cells of affected individuals. This will be an invaluable asset for understanding the     biology of blood disorders. The collected samples will be used by investigators for studies     including immunology, molecular biology and genetics to name a few.   "
253581|NCT01174628|"     The purpose of this study is to evaluate the long-term impact of Pulmonary Embolism (PE) on     heart and lung function, quality of life, ability to work, symptoms of breathlessness and     functional status of patients one year after their initial diagnosis and treatment for PE   "
253906|NCT01178268|"     This is a prospective, randomized, active-controlled, open label, parallel two-arm,     multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER     SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) (CYPHER SELECT PLUS) during     commercial use in China.   "
253582|NCT01174641|"     Problems in attention can affect around 40% of stroke survivors and are associated with poor     recovery of function. This project will provide the largest scale and most detailed     examination to date of whether problems in attention after stroke can be remediated through     direct brain stimulation. In Part 1 of the project the investigators will use two forms of     direct brain stimulation (neural inhibition) to try and balance activity across the two sides     of the brain following a stroke to one side. The investigators will assess whether each form     of stimulation leads to an improvement in attentional functions, as well as to wider     improvements in other cognitive abilities and to activities of everyday living. Performance     will be tested immediately post remediation and on longer-term follow-up, and performance of     the two intervention groups will be assessed against data the investigators have collected     from a large-scale screen of cognitive impairments and recovery of function under standard     treatment conditions. In Part 2 of the project the investigators will take the most promising     intervention from Part 1 and the investigators will use magnetic resonance imaging (MRI) to     determine the brain changes that are linked to the recovery of attentional functions. The     investigators will test whether recovery is linked to a change in the balance of activation     within the two hemispheres of the brain, and whether there are associated structural changes     in cortical tissue and fibre tracts. The project will evaluate whether neural inhibition can     improve attentional functions in particular, and cognitive abilities and everyday activities     more generally, in stroke survivors. It will also provide novel information on how recovery     of function comes about within the brain.   "
253583|NCT01174654|"     Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk     sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and     some authorities have advocated methamphetamine treatment as an HIV prevention strategy.     However, methamphetamine interventions have not been evaluated in controlled trials, nor have     they been implemented and assessed outside of substance abuse treatment programs. This     application proposes preliminary investigations to adapt a methamphetamine treatment     intervention previously associated with decreased sexual-risk taking among MSM for use as an     early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be     enrolled in a randomized controlled trial of contingency management (CM) versus no     intervention. CM participants will have their urine tested for methamphetamine 3 times weekly     for 12 weeks, and will receive vouchers of escalating value when their urines test negative;     vouchers will be withheld when participants' urines test positive for methamphetamine or     participants miss urine testing visits. All participants will undergo urine methamphetamine     testing and audio-computer assisted self-interviews on sexual behavior and substance use at     baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis,     rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and     6 month follow-up. The study will determine how often MSM will initiate and complete the     early intervention, and will longitudinally measure unsafe sexual behaviors among     intervention and control participants. Study results will determine the feasibility of     instituting and studying CM as an early intervention; define whether the intervention is     sufficiently promising to justify a larger, definitive randomized controlled trial; and will     provide estimates for defining the number of participants such a trial would require.   "
253584|NCT01174667|"     The aim of the study is to use diagnostic ultrasound to compare the thickness of soft tissues     in the low back in a group of patients with chronic low back pain treated with massage to a     control group of non-treated patients.      It is hypothesized that on average, soft tissue thickness in the lumbar region will change in     the group receiving massage compared to the control group.   "
253585|NCT01174680|"     The register study CGM@CAD will examine whether cardiogoniometry can provide additional     information concerning the indication for a diagnostic coronary angiography and if so, which     additional value it has. Therefore, an additional cardiogoniometry will be carried out in     consecutive patients who have been diagnosed with myocardial ischemia by means of established     methods (exercise ECG, stress echocardiography, myocardial scintigraphy, or stress-MRT) and     for whom an intracardiac catheter examination is regarded as indicated. The results of the     different methods - particularly the results of the exercise ECG and the cardiogoniometry -     will be checked against the results of the invasive examination as gold standard and the     discharge diagnosis with regards to any correlation.   "
253586|NCT01174693|"     The purpose of this study is to compare the preventive effect of stroke between triflusal and     clopidogrel in ischemic stroke patient based on the cytochrome P450 2C19 (CYP2C19)     polymorphism.   "
253587|NCT01174706|"     The main objectives of this research are:        1. To identify factors that influence medication adherence rates in Emergency Department          (ED) patients.        2. To measure the effects of alternative information prescriptions on medication adherence          rates of ED patients.        3. To measure the effects of alternative information prescriptions (IRxs) on health and          service utilization.   "
253588|NCT01174719|"     The aim of the study is to compare three different regimens for volume replacement during     cardiac surgery, e.g. Albumin 5%, Hydroxyethylstarch 130/0.4 (HES) and Ringer-Lactate (RL).      Main Outcome parameters: chest tube drainage and coagulation parameters. The investigators     hypothesis is that HES is as safe as Albumin, however less expensive. Whether RL is an even     less expensive and as safe alternative has to be shown.   "
253589|NCT01174732|"     This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover     and dose-ranging design. This study aims to evaluate the efficacy and initial safety     profiles, and to identify the optimum dose of A006, from a select dose-range for future     clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy,     adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to     Screening.   "
253590|NCT01174758|"     Developing technology to increase efficiency and decrease cost of clinical trials. The     longterm objective of this project is to use new technologies to sensitively measure,     automatically analyze and efficiently manage clinical trial data for Parkinson's disease (PD)     and other neurological disorders. This project will focus on developing objective measures of     balance and gait because mobility disability and falls are so critical for quality of life in     PD. Clinical movement disorders experts will team up with a local start-up business to     develop, produce, and test a novel clinical balance and gait assessment tool, the     instrumented Timed Up and Go Test (iTUG) for patients with Parkinson's disease. Balance and     gait will be measured with wireless sensors worn on the wrists, ankles and trunk while     patients stand up from a chair, walk, turn and return to sit on the chair. Accelerations and     angular velocities from the sensors will be automatically transmitted, stored, analyzed, and     displayed as Mobility Scores on a remote, centralized computer, along with other patient     information important for clinical trials. Specifically, this proposal will 1) create a     commercially-available, clinical trial system that includes completely wireless sensor     technology, a custom-made, user-friendly, computer interface and efficient data management     server; 2) develop a mobility score from many potential balance and gait measures and 3)     compare the sensitivity of the iTUG compared to traditional clinical tests of balance to     changes in PD due to antiparkinson medication. By providing a more sensitive, accurate, and     comprehensive method to quickly test and analyze balance and gait, clinical trials to improve     mobility in patients with Parkinson's disease and other neurological disorders will be     significantly more effective and efficient. This will permit clinical trials in Parkinson's     disease to be completed with fewer subjects, shorter duration, and less cost.The current     project will accelerate the development of new therapies for Parkinson's disease.   "
253591|NCT01174771|"     Drug therapy of atypical parkinsonism is generally considered either ineffective or minimal     1. Therefore, there is an urgent need to find alternative therapies to treat atypical     parkinsonian disorders. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive     tool that modulates cortical excitability with minimal discomfort and holds therapeutic     promise in treating neurological and psychiatric disorders.      The basal ganglia-thalamocortical circuits that are affected in Progressive Supranuclear     Palsy (PSP) and Corticocbasal Ganglionic Degeneration (CBGD) are likely structurally and     functionally segregated. The 'motor' circuit is implicated in parkinsonian akinesia and     hypokinesia; a 'prefrontal' circuit is implicated in working memory and mood regulation, and     linked with non-motor symptoms such as depression and apathy. In this proposal, we     characterize motor and prefrontal network dysfunction in PSP and CBGD patients, and propose     that high-frequency and low-frequency rTMS directed over separate motor and prefrontal     cortical targets of each network may show specific and selective beneficial effects on motor     vs. cognitive function in PSP and CBGD patients, respectively. Quantitative motor outcome     measures include timed finger tapping tasks. Quantitative cognitive outcome measures comprise     a visual analogue scale (VAS).      If successful, this pilot study will provide proof of principle data to suggest potential     benefits for rTMS in PSP/CBGD patients, and provide sufficient data and experience to support     future PSP/CBGD studies that include the use of rTMS to investigate the pathophysiology of     motor and non-motor features of PSP and CBGD patients.   "
253592|NCT01174784|"     This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a     single femoropopliteal chronic total occlusion (CTO). Safety and efficacy will be evaluated     during the index procedure through 30-day follow-up.   "
253593|NCT01174797|"     MTWA-CAD is a feasibility study designed to evaluate Microvolt T-Wave Alternans (MTWA)     testing for the purpose of detecting active ischemia in patients with known or suspected     coronary artery disease (CAD). MTWA is a subtle, alternating pattern in the T wave portion of     the surface electrocardiogram (ECG) that is associated with increased risk of ventricular     tachyarrhythmias and sudden cardiac arrest (SCA).   "
253594|NCT01174810|"     Exenatide is a licensed, safe and effective treatment for patients with Diabetes mellitus.     Laboratory work has shown strong, reproducible evidence that this drug has beneficial     disease modifying effects when given to animals with a range of experimental models of     Parkinson's disease (PD). This project aims to make an initial evaluation of possible     benefits of Exenatide among patients with moderate symptoms of PD. The drug will be given as     a twice daily 10microgram injection under the skin in a similar way to one of the     conventional symptomatic treatments for PD (Apomorphine).      Forty patients with moderate symptoms of PD will be recruited and randomised to receive     Exenatide injections twice daily, or to act as controls in this open label trial. Detailed     assessments will be made of all patients at baseline and periodically for a total of 14     months. The primary outcome measure will be the change between baseline and follow up, in the     severity of a validated PD assessment scale (the UPDRS part 3 motor score) after an overnight     period free of conventional PD medication. Secondary measures will include adverse event     reports, self completed questionnaires, and blood test results. Aside from these assessments,     all patients will continue their regular PD medications throughout the trial with adjustments     made only according to clinical need.      In a subgroup of patients (n=10), brain scans that assess the severity of PD, will be     performed at both baseline and follow up to help understand possible mechanisms of action of     Exenatide.   "
253595|NCT01174823|"     The purpose of this study is to study the safety and efficacy of bepotastine besilate     ophthalmic solution in allergic conjunctivitis patients.   "
253596|NCT01174836|"     Hypothesis: The majority of Emergency physicians and patients do not feel that specific     informed consent should be obtained for ED CT scans.      Secondary Hypothesis: Emergency attending physicians and residents will have similar     attitudes about CT scan consent issues. Physician attitudes toward obtaining consent for CT     scans will change after an educational program about the associated risks.   "
253597|NCT01174849|"     The purpose of this study is to determine whether an early schedule of a combination of three     doses of PHiD-CV and one dose of PCV13, is superior to three doses of either PCV13 or     PHiD-CV.   "
253618|NCT01175122|"     In recent years, influenza viruses that have traditionally infected animals have infected     humans as well. The H2N3 influenza virus, which first appeared in pigs in the Midwest United     States in 2006, may pose a potential health concern to humans. This study will evaluate the     safety of and immune response to a vaccine designed to protect people from the H2N3 influenza     virus.   "
253619|NCT01175135|"     This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of     acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study     will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for     PF-02545920 compared to risperidone and placebo treatment.   "
253620|NCT01175148|"     Atorvastatin for prevention of acute GVHD   "
253632|NCT01175304|"     The purpose of this study is the description of sleeping habits in a working population in     the investigators health care environment, analyzing the prevalence of daytime sleepiness and     symptoms compatible with the sleep apnea syndrome and finally to analyze predictors of     daytime sleepiness.   "
253598|NCT01174862|"     In patients undergoing coronary artery bypass graft (CAGB) surgery, aspirin is commonly     prescribed to prevent graft thrombosis and myocardial ischemia. However, there are still a     significant number of grafts occluding in the postoperative period. This is partly attributed     to reduced aspirin responsiveness, also called aspirin resistance. At the moment, no     standardized definition or laboratory test is available to quantify aspirin resistance, and     strong platelet reactivity in laboratory tests is not necessarily associated with increased     thrombotic events. However, there is increasing evidence that reduced aspirin responsiveness     in platelet function analyzers is associated with adverse long-term outcome and higher     incidence of major adverse events in patients with stable coronary artery disease and in     patients undergoing percutaneous coronary intervention. In patients undergoing coronary     artery bypass graft surgery, the predictive value of a laboratory finding of reduced aspirin     responsiveness remains unclear.      Therefore, the aim of this study is to prospectively evaluate whether the pre- and/or     postoperative laboratory finding of reduced aspirin responsiveness defined by MultiplateTM     platelet function analyzer is associated with higher incidences of adverse outcome after 30     days and 12 months in patients undergoing CABG surgery.   "
253599|NCT01174875|"     This study aims to test the following two hypotheses in women recruited in early pregnancy     and whose children will be followed up till at least 9 years of age.        -  Epigenetic changes in conceptual tissues obtained at birth reflect the environment that          the fetus was exposed to during development.        -  The pattern of epigenetic marks in gene promoters obtained from DNA in birth tissues,          together with genotype, phenotype, and environmental exposures, can be utilized to          assess how the perinatal environment affects subsequent metabolic, neurodevelopmental          and other phenotypes.   "
253611|NCT01175031|"     The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy     of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended     clinical polysomnography (PSG) in identifying breathing events in participants previously     diagnosed with complex sleep apnea (CompSAS), complex sleep apnea with Cheyne-Stokes     respiration (CSR), or obstructive sleep apnea (OSA).   "
253600|NCT01174888|"     RATIONALE: Bortezomib and midostaurin may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone     hydrochloride, etoposide, and cytarabine, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and     midostaurin together with combination chemotherapy may kill more cancer cells.      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when     given together with midostaurin with or without combination chemotherapy in treating patients     with relapsed or refractory acute myeloid leukemia.   "
253601|NCT01174901|"     Headache is a common symptom, and patients often seek medical attention at emergency     departments due to headaches.      The aim of the CoHead Study is to find out if it is possible by measuring copeptin, a marker     of stress in the blood, to find out which patients have simple headaches and which patients     have dangerous headaches that are the symptom of an underlying disease and need further     investigation and treatment.      Copeptin is a marker for physical stress and has been tested in patients with stroke, heart     attack and pneumonia. In all these illnesses, the patients with the most serious forms had     the highest levels of copeptin, while the ones with only mild presentation or no affection at     all had the lowest levels of copeptin.      The investigators expect to show the same in patients with headaches.   "
253602|NCT01174914|"     In the vast majority of those infected with HIV virus who are untreated, there is     deterioration in immune health over a period of months or years inevitably leading to     full-blown AIDS and demise. Treatment with ARV's stop or slow down this deterioration if     started before a certain degree of progression occurs and has saved millions of lives. The     investigators' study hypothesis is that effectiveness of a very low dose of an FDA-approved     medication, naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN) will compare favorably to     ARV's to prevent progression of HIV+ toward immune deterioration and full-blown AIDS.   "
253603|NCT01174927|"     The aims of the study are to investigate the effects of diacetylmorphin (heroin) on brain     using functional magnetic resonance imaging (fMRI), coupled with measurements of cortisol     concentrations and neurophysiological stress parameters during the presentation of emotional     and cognitive stimuli in patients with heroin dependence.   "
253604|NCT01174940|"     To study the effect of ECP with Uvadex® in conjunction with a standard myeloablative     conditioning regimen on the incidence of acute and chronic GvHD in patients undergoing an     allogeneic related or unrelated BMT or PBSC transplant, for treatment of hematologic or     lymphoproliferative malignancies.   "
253605|NCT01174953|"     The purpose of this study is to study the molecular effects of the chemopreventative agent,     finasteride, in combination with dietary soy supplementation in patients at high risk for the     development of prostate cancer. Also, the investigators intend to create a large database     with health information from men who are at high risk of developing prostate cancer, along     with serum and tissue samples from those patients who are willing to provide tissue and serum     samples.   "
253606|NCT01174966|"     The lack of subcutaneous partial pressure of oxygen (PO2) rise in response to high fraction     of inspired oxygen (FiO2), called the oxygen challenge test (OCT), was associated with     higher morbidity and mortality in human subjects. Patients had negative O2 challenge test     results, indicating that flow-dependent O2 consumption might have been present. Recent     reports using the noninvasive transcutaneous PO2 (PtO2) and transcutaneous partial pressure     of carbon dioxide probes have observed a relationship between low oxygen challenge test     values to mortality and organ failure. The OCT values provides an accessible noninvasive     method of detecting early shock.      To date,these studies of OCT in the ICU patients are rarely. No one has quantified OCT to CI,     DO2I、ScvO2.      This study explored:        1. relationship between patient factors, hemodynamic variables, PtO2, and OCT to mortality;        2. relationship between PtO2 index, tissue oxygen index, oxygen Challenge index to CI, DO2,          ScvO2.   "
253607|NCT01174979|"     This trial is a randomized, double blind, placebo controlled study on patients suffering from     inner ear diseases with tinnitus as a principal symptom.      The study will investigate the transtympanic treatment with a 1,5 % caroverine solution.      Each patient will undergo treatment for 2 cycles of 48 hours each.   "
253609|NCT01175005|"     Procalcitonin (PCT) is one of many inflammatory markers which rises in response to infection.     Many studies have shown this marker to be more indicative of a patient's clinical course in     comparison to other inflammatory markers, such as Erythrocyte Sedimentation Rate (ESR) and C     reactive protein (CRP), when assessing a patient's risk for serious infection. A particular     population with potential for serious infection is that of the patient with fever and a     central line, most often secondary to an oncologic disease. These patients are often     neutropenic and unable to fight off infection, thereby rendering them extremely vulnerable to     rapid declines in clinical status. By identifying a level of procalcitonin which is     significant as a threshold for serious bacterial infection, the investigators can very early     on identify the sickest patients and those who could potentially have a worse clinical course     and/or outcome.      The primary study goal is to identify whether a level of procalcitonin exists above which     rates of bacteremia or serious bacterial infections in patients with fever and a central line     exist. The investigators will try to determine if levels of PCT correlate with bacterial     infection in line sepsis in the specific population of patients who most often have a central     line secondary to an oncologic process. The investigators proposed this theory since peak     values of PCT have been shown to be elevated in acute settings making it a useful tool in     this particular population.   "
253610|NCT01175018|"     Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many     patients die early during the course, and those who survive are at risk for dying late from     adverse cardiac remodeling and heart failure.      The initial ischemic damage to the myocardium initiates an intense inflammatory response in     promoting further cardiac dysfunction and heart failure. The investigators propose that an     antiinflammatory strategy based on blockade of Interleukin-1 will quench the inflammatory     response and lead to a more favorable cardiac remodeling process.   "
253612|NCT01175044|"     The purpose of this study is to examine the efficacy of a dilute betadine solution in     reducing infectious complications in revision total knee arthroplasty. The investigators will     enroll patients who are scheduled to undergo a revision total knee arthroplasty. Patients     will be randomized into two groups. The treatment group will receive a dilute betadine lavage     prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation and     the control group will receive the 2000ml sterile saline lavage alone.   "
253613|NCT01175057|"     In this study feasibility of the MeDiNa concept is looked at, which means telemedical     services for homely rehabilitation. With the help of microsystems technology, the relevant     vital signs are measured at the patient`s home, then transmitted to the MeDiNa- Homebox-     Tablet PC (by bluetooth) and then transferred into a central database, the MeDiNa eHealth-     portal (by HSDPA, UMTS). These parameters can be continuously monitored by authorized network     participants such as the family doctor or the patients themselves. In future, beyond cost     advantages this will help to supervise risk patients or inspire patients to take more care of     their health during homely rehab.   "
253614|NCT01175070|"     Diabetic macular oedema (DME) is one of the leading causes of blindness in the United     Kingdom's working population. It affects the macula, which lies at the centre of the retina,     at the back of the eye. Damage to the macula can occur either because the blood supply is     reduced (ischaemic DME), or because the blood vessels are leaking excessively (exudative     DME).      A chemical called vascular endothelial growth factor (VEGF) may underlie some of the     abnormalities seen in DME. Studies have shown that VEGF encourages leakage of fluid from     blood vessels and increases the stickiness of white blood cells. When white blood cells are     sticky they can attach to blood vessel walls. This may cause small blood vessels to block,     and lead to ischaemia.      Laser treatment often helps to stabilise exudative DME, but there is currently no recognised     treatment for ischaemic DME. Macugen (pegaptanib), a drug that inactivates VEGF, has been     tried and found to be of benefit in treating exudative DME. Since VEGF promotes ischaemia, it     is possible that Macugen will also prove to be beneficial for ischaemic DME. This has not     been tested before.      A healthy macula is essential for good vision. The innermost area of the macula, the foveal     avascular zone (FAZ), is the most important part. The FAZ is enlarged when it is ischaemic.     This is a pilot study to assess whether Macugen can reduce the size of the FAZ in ischaemic     DME. The investigators will also assess whether it can reduce retinal thickness and improve     vision in ischaemic DME. Thirty patients will be involved in the study for thirty weeks each.     They will have their eyes examined and receive an injection of Macugen into the eye every 6     weeks. The study is taking place in the Oxford Eye Hospital and is being funded by Pfizer,     the company that makes Macugen.   "
253615|NCT01175083|"     The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK     Biologicals' pneumococcal conjugate vaccine GSK1024850A.      Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib     and OPV vaccines.   "
253616|NCT01175096|"     RAD001 continues to be investigated as an anticancer agent on new indications such as     neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and     lymphoma based on its potential to act:        -  directly on the tumor cells by inhibiting tumor cell growth and proliferation        -  indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent          inhibition of tumor cell HIF-1 activity and VEGF production and VEGF-induced          proliferation of endothelial cells)      A role for RAD001 in combination with Sandostatin LAR® Depot in the treatment of advanced     carcinoid tumor is suggested by data on the regulatory role of mTOR in cell growth and     protein translation and the finding that somatostatin-induced growth arrest is mediated in     part by inhibition of the PI3K pathway (Charland, et al. 2001).      The present study is designed to collect safety/tolerability data and evidences for efficacy     of RAD001 in the medically highly unmet indication of advanced pulmonary neuroendocrine tumor     in Chinese patients.   "
253617|NCT01175109|"     This is a multi-center study to assess the safety and to determine the maximum tolerated dose     of the combination of imatinib and LBH589 in patients with newly diagnosed and recurrent     chordoma. For the recurrent population, those patients that do not require immediate surgical     resection will be eligible. Patients will be treated with 4 cycles, followed by surgical     resection if possible. If indicated, surgery may take place prior to the completion of 4     cycles.   "
253621|NCT01175161|"     The purpose of this non-blinded randomized clinical trial is to pilot the design of a     randomized clinical trial to be conducted in Malawi to investigate immediate postpartum     insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to     placement at the 6-week postpartum visit.      The investigators hypothesize that it will be feasible to enroll 140 women into this study,     and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.   "
253635|NCT01175343|"     This phase II trial is studying the side effects and how well RO4929097 works in treating     patients with recurrent and/or metastatic epithelial ovarian cancer, fallopian tube cancer,     or primary peritoneal cancer. RO4929097 may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth.   "
253725|NCT01176435|"     This project will evaluate the effect of two doses of levodopa (L-DOPA) in a randomized,     placebo-controlled, double-masked clinical trial to see if vision can be improved in     individuals with albinism. The hypothesis is that providing L-DOPA to the retinas of these     individuals may increase melanin pigment production. Increased melanin has previously been     shown to be associated with improved vision.   "
253622|NCT01175174|"     Clinical, Airway Inflammatory, and HRA Phenotypes, in preschool children with acute asthmatic     attack presenting to the ED.      Background:      Children under the age of 5 years have the highest hospitalization rate of asthma. The most     common causes of acute exacerbations of asthma requiring urgent medical care are viral     respiratory infections. Most of these children < 6 y old are not atopic.      The inflammatory response to these mostly viral-induced asthmatic attacks is not well     characterized in the literature. Moreover it is not known whether different kind of     inflammatory responses exist in this population and how this correlate to clinical outcomes     and clinical phenotypes in preschool children presenting ti the ED with acute asthmatic     attack.      Therefore, the purpose of the present study is to:      Investigate the characterization of induced sputum cytology in preschool children with acute     asthmatic attack and whether there is correlation between specific sputum cytology and     response to therapy and to investigate airways hyper-responsiveness to adenosine     5'-monophosphate and to metacholine in pre school children 2-6 y old at 2 weeks and at 3     month following acute asthmatic exacerbation and look for correlation with response to     treatment and sputum cytology. Clinical phenotypes of this patient population will also be     investigated.   "
253623|NCT01175187|"     Intrapartum fever associated with epidural anesthesia is caused by non infectious causes     therefore without histological findings   "
253624|NCT01175200|"     This study will establish the optimal therapeutic strategy for patients with a coronary     artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring     co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for     treatment/prevention of GI ulceration.   "
253625|NCT01175213|"     The original purpose of the study was to assess the long-term safety, tolerability, and     practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution     (IGSC), 10% facilitated with recombinant human hyaluronidase (rHuPH20) in participants with     Primary Immunodeficiency Diseases (PID) who had completed Baxalta (formerly Baxter) Clinical     Study Protocol No. 160603.      Following a discussion with the FDA at the end of July 2012, all participants still active in     the study stopped treatment with rHuPH20 to assure safety of the participants participating     in the study and went into a safety follow-up.      During this safety follow-up period, participants underwent either SC treatment with IGSC,     10% or intravenous (IV) treatment with Immune Globulin Intravenous (Human) (IGIV), 10%. The     IV or SC administration route was at the discretion of the participant and the investigator.   "
253626|NCT01175226|"     This study aims to evaluate the safety, tolerability and effectiveness of BTA798 on        -  shortening the length and reducing the symptoms of human rhinovirus infection (also          known as the common cold),        -  controlling asthma symptoms, and        -  lowering the risk of asthma symptoms worsening in subjects with asthma.   "
253627|NCT01175239|"     X-linked severe combined immunodeficiency (SCID-X1) is an inherited disorder that results in     failure of development of the immune system in boys. This trial aims to treat SCID-X1     patients using gene therapy to replace the defective gene.   "
253628|NCT01175252|"     This study aims at collecting data to obtain baseline incidence and monitor trends over time     in hospitalizations and deaths from all cause gastroenteritis in children <5 years of age,     before and after implementation of Rotarix™ universal mass vaccination in Brazil.   "
253629|NCT01175265|"     Conventional pulmonary rehabilitation programs improve exercise tolerance, peripheral muscle     strength, and health related quality of live but not pulmonary function in patients with     chronic obstructive pulmonary disease (COPD). The role of breathing retraining techniques in     the rehabilitation of patients with COPD remains unclear. The hypothesis to be tested in this     study is that pulmonary function, cardio-pulmonary exercise capacity, health related quality     of life and cardiac autonomic modulation of patients with COPD who undergo pulmonary     rehabilitation plus breathing retraining will be better than that of patients undergoing a     conventional pulmonary rehabilitation.   "
253630|NCT01175278|"     The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the     patient's fracture using balloons and bone cement) compares to non-surgical treatment in     reducing vertebral compression fractures while providing pain relief and improved function     and quality of life.   "
253631|NCT01175291|"     The purpose is to study the efficacy (effectiveness) of a new drug, MK-0646, in metastatic     colorectal cancer. MK-0646 is an investigational or experimental anti-cancer agent that has     not yet been approved by the U.S. Food and Drug Administration (FDA) for use in metastatic     colorectal cancer or any other disease.      This study will assess whether adding MK-0646 to an FDA-approved standard of care     chemotherapy improves participants' duration of progression-free survival. MK-0646 is     believed to inhibit the receptor of a protein called IGF-1 (Insulin-like Growth Factor) which     is thought to contribute to cancer development and growth. However, there is no guarantee     that MK-0646 will slow cancer development and growth.      Other purposes of this study include:        -  looking at the safety and tolerability of MK-0646        -  comparing MK-0646 + standard of care chemotherapy with placebo + standard of care          chemotherapy (placebo is a substance that looks like an active drug but has no active          ingredient) The standard of care chemotherapy in this study is called FOLFOX 7. FOLFOX 7          includes the drugs oxaliplatin with leucovorin, 5-Fluorouracil (5-FU), and bevacizumab.   "
253633|NCT01175317|"     58 patients undergoing surgery of the large bowel are divided into two groups. The control     group will receive standard care. The intervention group will receive standard care plus     optimization of the blood circulation based on in- or decrease of the output of the heart.     Between group differences are measured primarily by markers of intestinal damage in plasma     and urine. Also CO2 pressure in the stomach lumen is measured (reflecting blood supply to the     gut).      The investigators hypothesize that the intervention group will have less intestinal damage,     improved blood supply to the bowel and improved recovery of the operation compared to the     control group.   "
253634|NCT01175330|"     The purpose of this study is to evaluate efficacy of Polyunsaturated Fatty Acid for the     prevention of Atrial Fibrillation and anti-inflammatory effects in patients after CABG     surgery   "
253636|NCT01175356|"     This clinical trial is studying induction therapy followed by meta-iodobenzylguanidine (MIBG)     labeled with iodine-131 and chemotherapy in treating patients with newly diagnosed high-risk     neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy     with isotretinoin. Radioisotope therapy, such as MIBG labeled with iodine-131, releases     radiation that kills tumor cells. Drugs used in chemotherapy, such as cisplatin, etoposide,     busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. A peripheral stem cell transplant can     replace blood-forming cells that are damaged by MIBG labeled with iodine-131 and     chemotherapy.   "
253637|NCT01175369|"     Asthma is the most common chronic illness of childhood, and hospitalization rates are     increasing. In the US, impoverished children and children from minority ethnic and racial     backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood     Institute (NHLBI) guidelines recommend daily preventive medications for all children with     mild persistent to severe persistent asthma, studies indicate that many children in the US     who should receive preventive medications are not receiving them. The overall goal of this     project is to target an ethnically diverse population of inner-city schoolchildren with     asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that     children receiving a comprehensive school-based intervention will experience less     asthma-related morbidity compared to children receiving usual care. Our comprehensive     school-based intervention consists of both administration of recommended preventive asthma     medications in school (with dose adjustments according to NHLBI guidelines) and an     environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children.     Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who     receive the school-based intervention with ETS reduction will experience less asthma     morbidity than those who receive usual care.   "
253638|NCT01175382|"     The primary aim of this project is to evaluate the effectiveness of combined behavioral +     drug therapy compared to behavioral treatment alone and drug therapy alone as a way to     improve outcomes in the treatment of OAB symptoms in men. We hypothesize that combined     therapy will result in better outcomes than either behavioral or drug therapy alone. The     second aim is to compare two methods of implementing combined therapy: simultaneously as     initial therapy vs. stepped therapy, in which therapies are combined following initial     behavioral or drug therapy alone. The third aim is to examine the costs and     cost-effectiveness of combined behavioral + drug therapy compared to behavioral or drug     therapy alone.   "
253639|NCT01175395|"     The primary purpose of this study is to assess the safety & tolerability of an     investigational drug 20089 TA (6.9 mg or 13.8 mg) when used adjunctively with Lucentis 0.5 mg     in subjects with sub-foveal neovascular AMD.   "
253640|NCT01175408|"     Management of type 2 diabetes is an ongoing challenge for patients and their doctors. In     order to prevent complications, patients need to monitor and control their blood sugar     levels. In addition, they may need to have an ongoing communication with their doctor in     order to modify treatment. In this study the investigators wish to compare the benefits of     continuous glucose monitoring system (CGMS) to an internet-based glucose monitoring system     (IBGMS). The investigators also want to determine whether the frequency of blood glucose     testing affects blood glucose control and to see whether the benefits of CGMS and IBGMS are     independent of testing frequency.   "
253641|NCT01175421|"     Purpose:      In a retrospective cohort the investigators will validate, the goodness of a multidimensional     index to classified the severity of patients with sleep disordered breathing that has been     previously developed in a prospective longitudinal cohort.   "
253642|NCT01175434|"     The goal of this new translational project is to test the feasibility and effectiveness of     implementing school-based directly observed therapy of preventive asthma medications in a     real-world setting, using state-of-the-art web-based technology for systematic screening,     electronic report generation, and communication between nurses, caregivers, and primary care     providers. With the use of a novel method to improve adherence and subsequently reduce     morbidity, the investigators hypothesize that this novel adaptation of school-based asthma     care will; 1) be feasible and acceptable among this population and among school and community     stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and     emergency room / urgent care use for asthma care). The investigators anticipate that     enhancing preventive healthcare for young urban children with asthma through partnerships     with the schools using a novel technology will yield improved health, prevention of     suffering, decreased absenteeism from school, and reduced healthcare costs.   "
253643|NCT01175447|"     Elderly patients with esophageal cancer will receive thoracic radiation therapy 54Gy over 30     fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70,     and 80 mg/m(2)/day.   "
253644|NCT01175460|"     Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30     fractions,and concurrent with s-1 and nedaplatin.   "
253655|NCT01175603|"     The goal of this study is to determine whether a 6 week intervention is effective in     preventing the worsening of depressive symptoms and development of clinical depression in     low-income African American pregnant and recently delivered women who are enrolled in home     visiting programs.   "
253882|NCT01177956|"     The primary objective of this trial is to assess the antitumor activity and safety profile of     cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line     treatment of recurrent and/or metastatic Squamous Cell Carcinoma in Head and Neck (SCCHN) in     Asian subjects.   "
253645|NCT01175473|"     The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010),     in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks     of treatment.      The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide,     in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose     concentration curve (AUC) after a standardized breakfast at Week 4.      The secondary objectives are to assess the effects of lixisenatide on the maximum PPG     excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma     concentrations following a standardized breakfast, 24-hour profile of plasma glucose,     glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY [PYY3-36] and     oxyntomodulin); and to assess the clinical and laboratory safety profile.   "
253683|NCT01175967|"     RATIONALE: Measuring changes in performance status and symptoms distress in patients with     cancer may help doctors predict how patients will respond to treatment, and may help the     study of cancer in the future.      PURPOSE: This clinical trial is studying changes in performance status and symptoms distress     in older patients with advanced ovarian epithelial cancer undergoing surgery and/or     chemotherapy.   "
253726|NCT01176448|"     Dermabrasion has been the historical standard used for resurfacing scars on the skin.     Recently, fractionated laser therapy has been FDA approved for scar resurfacing. This study     intends to compare dermabrasion versus fractionated laser therapy for scar resurfacing.   "
253646|NCT01175486|"     Objectives:      Thiazolidinediones (TZDs) are insulin sensitizers that decrease plasma glucose in type 2     diabetic patients. Thiazolidinediones can cause fluid retention and peripheral edema in     diabetic patients, and the systematic fluid retention can be manifested as diabetic macular     edema (DME). The overall goal of this study is to examine the effects of thiazolidinediones     on the diabetic retinopathy and nephropathy.      Study design:      This is a prospective, randomized, open-labeled, controlled design to assess the effects     thiozolidinediones on the diabetic retinopathy and nephropathy. The investigators will     recruit 300 type 2 diabetic patients without significant retinopathy, nephropathy and     cardiovascular disease. Inclusion criteria are type 2 diabetes, age between 30-80 years old,     with microabluminuria, no significant retinopathy, on submaximal dose of sulphonylureas and     metformin treatment, and A1C between 7-9%. Exclusion criteria are on insulin treatment,     significant retinopathy and significant nephropathy. Patients with cardiovascular diseases,     malignancy, pregnancy, in acute intercurrent illness, congestive heart failure, myocardial     infarction, received PCI or CABG. All subjects will receive EKG and CXR before randomization.      These subjects will be randomized equally to 3 groups: acarbose, rosiglitazone and     pioglitazone. The investigators will follow up for 6 months to investigate the short-term     effects and 5 years to evaluate the long-term outcomes. The primary study end point of     short-term study will be the macular thickness changes measured by optical coherence     tomography, the changes in the level of urinary albumin-to-creatinine ratio, circulating     metabolic parameters and adipocytokines during thiozolidinediones treatment. Secondary end     point will be fasting blood glucose, A1C levels, development of clinically significant     macular edema, serum creatinine change in patients with no history of diabetic retinopathy     and nephropathy at baseline.      The primary study end point of long-term study will be the development of clinically     significant macular edema and the time from the base-line visit to the first detection of     overt nephropathy. Secondary end points include the development of greater than moderate     NPDR, the time to the first event of the time from the base-line visit to a doubling of the     serum creatinine concentration, end-stage renal disease, or death.   "
253647|NCT01175499|"     This study will compare TNFE-NBI and biopsy, with DRE and biopsy for the diagnostic     evaluation and staging of patients with suspicious UADT lesions. All patients enrolled in the     study will undergo TNFE-NBI with biopsy of suspicious lesions prior to planned regular     clinical care (DRE). Biopsies will be evaluated by standard clinical methods for patient     diagnoses and care. As the current standard of care, if all biopsies for a given patient are     non-malignant, a 3 month office visit will be arranged to evaluate and determine the need for     further intervention. At the end of study enrollment both sets of biopsies will be     re-evaluated in a blinded fashion by the surgical pathologist. Study assessment of malignant     vs. non-malignant (benign) pathology will be used to see whether both tests tended to agree     on diagnoses.   "
253648|NCT01175512|"     The investigators will develop a measure of endogenous opioid tone that might serve as a     biological marker for drive for palatable food. Using a 'naltrexone probe,' the investigators     will assess whether individual response to one dose of an opioid receptor antagonist,     naltrexone, is related to non-homeostatic eating in non-pregnant women.      Hypothesis 1: Naltrexone Response will be related to non-homeostatic eating.      Hypothesis 2: Response profiles to the 25 mg dose will be slightly less in magnitude than the     50 mg dose. However, responses will be similarly related to non-homeostatic eating measures.      Hypothesis 3: Response to naltrexone will be highly stable within individuals across time, in     the absence of an intervention.   "
253649|NCT01175525|"     Mastocytes were proven to have a central rule in their development of the lipoid plaque of     the vascular system. Mastocytes also has an important role in the stabilisation of the plaque     in the building of the brain barrier. Different animal studies show that the inhibition of     the mastocyte activity decreases significantly the risk of secondary bleeding post ischaemic     stroke.It was also shown that post stroke inflammation process was also blocked by the     inhibition of mastocytes.Other studies showed up to 100% decrease in the brain barrier     disruption and post stroke oedema, after treatment with mastocyte inhibitors.      Cromolyn is a synthetic drug which has an anti-allergic effect by inhibition of the     mastocytes. This drug is a well known,safe drug and is the main sub-substance that was used     in the previously mentioned studies.   "
253650|NCT01175538|"     To assess the effects of lactulose for the prevention of first episode of altered sensorium     (hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.   "
253651|NCT01175551|"     Racism and health care system distrust are potent stressors and may be associated with     preterm birth (PTB). Additionally, cervical shortening is a common pathway leading to PTB.     This study is enrolling a prospective cohort of pregnant women. The study assesses racial     discrimination, health care system distrust, and cervical change using 2 questionnaires,     exam, and protein levels in cervical vaginal fluid and maternal serum.   "
253652|NCT01175564|"     The purpose of this study is to assess safety, tolerability and pharmacokinetics after a     single and repeated oral doses of TC-5214 (S-mecamylamine) in healthy male Japanese subjects.   "
253653|NCT01175577|"     The primary purpose of this study is to compare the change in blood carotene concentration     between a food-based versus nutritional supplement-based intervention. This study will     randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural,     mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. Blood     carotene levels will be measured before and after 28 days of supplementation. Preliminary     data will also be collected on several biomarkers associated with vascular inflammation and     endothelial dysfunction. These biomarkers will be measured before and during a fast food     control meal at the beginning and end of the intervention period.   "
253654|NCT01175590|"     The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic     suspension, 0.6%) compared to vehicle.   "
253656|NCT01175616|"     The purpose of this study is to determine whether creatine will be helpful as an adjunctive     treatment for treatment-resistant major depressive disorder (MDD) in female and male     Veterans. We hypothesize that Veterans receiving creatine will show decreased depressive     symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). We will also     use 31-Phosphorus Magnetic Resonance Spectroscopy (31-P MRS) brain scans to compare levels of     neurochemicals related to energy metabolism in the brain, before-and-after treatment with     creatine, and between healthy controls and MDD participants.   "
253684|NCT01175980|"     This phase II trial studies how well vorinostat works in treating patients with adenoid     cystic carcinoma that has come back (recurrent) or that has spread from where it started to     nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body     (metastatic). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.   "
253657|NCT01175629|"     The purpose of The Veteran Health Study (CSP #569) is to better understand the mental and     physical health of veterans as they get older. We are inviting approximately 10,000 members     of the Vietnam Era Twin (VET) Registry to participate. As veterans approach their     mid-sixties, it is important to understand the impact of wartime deployment on health and     mental health outcomes nearly 40 years later.      The investigators will assess the prevalence of post-traumatic stress disorder (PTSD) and     other mental and physical health conditions for Vietnam era veterans, and explore the     relationship between PTSD and other conditions.      CSP #569 involves 3 phases of data collection. In Phase I, VET Registry members are invited     to complete a paper and pencil questionnaire including items on physical and mental health,     disability, health behaviors, demographic information and use of health care services. After     completing Phase I, VET Registry members are invited to Phase II which involves a telephone     interview about mental health. In Phase III, some of those who participated in Phase I will     be invited to a sub-study confirming self-reported heart disease and diabetes using a     provider survey.      Data collected for CSP #569 will be combined with existing VET Registry data. This will     provide a rich picture of the health of Vietnam era veterans and the influence of PTSD on the     lives of veterans.   "
253658|NCT01175642|"     This randomized trial is examining whether a treatment called cognitive remediation is more     effective when it is paired with a social and functional skills training component.   "
253659|NCT01175655|"     The primary aim of this study is to establish the safety of infusions of Mesenchymal Stromal     Cells (MSC) from related or unrelated Human Leukocyte Antigen (HLA) identical or HLA     mismatched donors in the management of bronchiolitis obliterans syndrome after lung     transplantation.   "
253660|NCT01175668|"     The study plans to compare the use of Clonidine versus Phenobarbital as an additional     medication to neonatal morphine sulfate for treatment of newborn infants undergoing drug     withdrawal symptoms due to mother's use of opioid drug use. The investigators hypothesis is     that use of Clonidine will lead to shorter duration of treatment, hospital stay and thereby     early discharge home.   "
253661|NCT01175681|"     Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery     including coronary artery bypass graft surgery, congenital heart disease and aneurysm.     However, no data was reported on heart valve disease surgery. Rheumatic heart disease is one     of the major heart diseases requiring surgery in China. Thus, the investigators chose heart     valve disease as a focus to see whether remote ischaemic preconditioning also has cardiac     protective effect during heart valve surgery.   "
253662|NCT01175694|"     Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with     lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a     highly selected subgroup of patients with low risk invasive carcinoma and low risk duct     carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of     pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial     Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal     carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular     regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II     study. According to study protocol altogether 200 female patients will be treated.   "
253663|NCT01175707|"     This is a randomized, open-label, multi-center, phase 4 study designed to compare intravenous     (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment     of complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria in     participants who are prescribed vancomycin for 7 to 14 days and who are planning to receive     vancomycin in a home-infusion setting.   "
253664|NCT01175720|"     The aim of this study is to test a surgical technique for the treatment of gingival     recessions. The hypothesis of the study is to promote greater root coverage and better     healing.   "
253665|NCT01175733|"     The purpose of this study is to investigate whether the addition of panitumumab to     radiotherapy plus gemcitabine will increase the number of patients who are alive and     progression free at 7 months.   "
253666|NCT01175746|"     Since nicardipine is known to protect kidney function, nicardipine infusion will result in     better renal parameters measured in this study.   "
253667|NCT01175759|"     The EVE- technology is intended for determination of intolerance or sensitivity to female sex     hormones among women with hormone-related conditions and for further treatment by     desensitization procedure inducing a tolerance to the hormones the women are sensitive to.      This study is designed to evaluate the safety and the ability of the EVE- Skin-Test Panel to     detect sensitivity to female sex hormones in subjects with Unexplained Recurrent Pregnancy     Loss (URPL) and in Control parous, healthy women.      The Skin Test Panel includes four female hormones and three control solutions.      Hormones from the Skin Test Panel are injected intradermally during the luteal phase of the     subject's menstrual cycle. The skin reactions are examined by physician for erythema and     wheal after 20 minutes and 48 hours and self-assessed by the patient daily for the following     month.      Skin response monthly data is analyzed and compared between unexplained recurrent pregnancy     loss (UPRL) and healthy groups.      Following achievement of the significant differences between both groups the immune profile     of the healthy and UPRL subjects will be investigated.   "
253702|NCT01170689|"     This study is the first hospital-based, cross-sectional study to discuss the prevalence of     obesity among 710 inpatients with schizophrenia.   "
253668|NCT01175772|"     Preclinical studies showed that metronomic chemotherapy can induce tumor regression secondary     to apoptosis of the tumor blood vessels. This effect was increased by combining metronomic     chemotherapy with anti-angiogenic drugs. Metronomic chemotherapy has already proved clinical     effects too, especially on patients with breast or prostate carcinoma. This study is aimed to     test the efficacy of an experimental metronomic chemotherapy regimen in a cohort of patients     with ovarian cancer. Patients will receive the proposed regimen as maintenance treatment     following response induction by the conventional maximal tolerated dose (MTD) regimen of     Carboplatin and Paclitaxel. Our regimen will include Cytophosphan combined with two agents     which are expected to act as indirect angiogenic inhibitors: (a) celecoxib, as a selective     COX-2 inhibitor and (b) low-dose Methotrexate, as successfully practiced for suppressing the     inflammatory manifestations of rheumatoid arthritis. All components of our regimen will be     administered orally and continuously for one year based on the hypothesis that its     anti-angiogenic properties will be able to suppress the recovery of residual disease, thus     extending the time to progression (TTP), and possibly the overall survival as well.   "
253669|NCT01175785|"     This phase II trial is studying the safety and potential efficacy of infusing non-human     leukocyte antigen matched ex vivo expanded cord blood progenitors with one or two     unmanipulated umbilical cord blood units for transplantation following conditioning with     fludarabine phosphate, cyclophosphamide and total body irradiation, and immunosuppression     with cyclosporine and mycophenolate mofetil for patients with hematologic malignancies.     Chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation     given before an umbilical cord blood transplant stops the growth of leukemia cells and works     to prevent the patient's immune system from rejecting the donor's stem cells. The healthy     stem cells from the donor's umbilical cord blood help the patient's bone marrow make new red     blood cells, white blood cells, and platelets. It may take several weeks for these new blood     cells to grow. During that period of time, patients are at increased risk for bleeding and     infection. Faster recovery of white blood cells may decrease the number and severity of     infections. Studies have shown that counts recover more quickly when more cord blood cells     are given with the transplant. We have developed a way of growing or expanding the number     of cord blood cells in the lab so that there are more cells available for transplant. We are     doing this study to find out whether or not giving these expanded cells along with one or two     unexpanded cord blood units is safe and if use of expanded cells can decrease the time it     takes for white blood cells to recover after transplant. We will study the time it takes for     blood counts to recover, which of the two or three cord blood units makes up the patient's     new blood system, and how quickly immune system cells return.   "
253670|NCT01175798|"     Dialysis patients often suffer from defects in their immune system (that part of the body     which fights infection). Evidence suggests that Vitamin D deficiency may have a negative     effect on immunity, and many dialysis patients are deficient in Vitamin D. We believe that by     giving Vitamin D to dialysis patients who are deficient, we may help improve their immune     system. This study will test that idea.   "
253671|NCT01175811|"     The purpose of the study is to compare the effects on overall glycaemic control of two     insulin intensification therapies.   "
253672|NCT01175824|"     The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal     insulin glargine and once-daily prandial insulin lispro, in participants with Type 2     Diabetes.   "
253673|NCT01175837|"     This clinical trial studies short-term fasting before chemotherapy in treating patients with     cancer. Fasting before chemotherapy may protect normal cells from the side effects of     chemotherapy.   "
253674|NCT01175850|"     The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral®     drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery,     as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides     the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel)     from the balloon surface into the vessel walls. This drug absorption is intended to limit the     chances and the entity of artery re-narrowing over time.   "
253675|NCT01175863|"     This study is a prospective, randomized, multi-center, open label trial to compare the     clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow     Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary     artery lesion.   "
253676|NCT01175876|"     Remote limb ischemic preconditioning is neuro-protective and anti-inflammatory for ischemia-     reperfusion injury. As the extent of its effect is unknown, the investigators will use     clinical outcome, serum biochemical markers and diffusion-weighted magnetic resonance imaging     (DW-MRI)to determine the extent of its neuro-protective and anti-inflammatory effect.   "
253677|NCT01175889|"     The Megadyne Ace™ Incision/ Dissection study is a post market, prospective assessment of the     E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted     procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts,     bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination     thereof.   "
253678|NCT01175902|"     To prove the non-inferiority of the fixed timolol-dorzolamide combination (Cosopt) compared     to 0.005% latanoprost (Xalatan) in the aspects of intraocular pressure (IOP) and ocular     perfusion pressure (OPP) in subjects with normal tension glaucoma (NTG)      Clinical hypotheses. Primary hypothesis        -  Cosopt group is non-inferior to Xalatan group in diurnal IOP reduction.      Secondary hypothesis        -  Cosopt group is non-inferior to Xalatan group in diurnal diastolic and systolic OPP.   "
253679|NCT01175915|"     The aim of this study is to evaluate the effectiveness and safety of Reduning Injection for     mild type of hand-foot-mouth disease.   "
253680|NCT01175928|"     The purpose of this study is to evaluate the efficacy of the NormaTec PCD, a non-invasive     pneumatic compression device with the patented peristaltic pulse pneumatic waveform, in the     treatment of Diabetic Peripheral Neuropathy (DPN).      The study will compare treatment with a NormaTec PCD and a sham device to assess whether the     NormaTec PCD improves the signs and symptoms of DPN.   "
253891|NCT01178073|"     The purpose of this study is to compare the two treatment strategies; first-line combination     therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil)     in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first     clinical failure event.   "
253681|NCT01175941|"     This is a study to examine the effect of alpha adrenergic stimulation of the anal canal and     rectum on parameters affecting the control of defecation in subjects with faecal     incontinence. The study will investigate the effects of rectal suppositories containing 10 mg     NRL001 given for seven days, once daily. Rectal compliance and median anal resting pressure     will be considered the primary objective of the study. A pharmacokinetic evaluation plus     safety and tolerability assessment including monitoring of electrocardiograms (ECGs), blood     pressure and heart rate will also be evaluated as secondary objectives.   "
253682|NCT01175954|"     Primary Objective:      Null hypothesis: A 24-week trial of adjunctive Lacosamide does not produce a decline in     cognitive, mood or quality of life measures.      To determine the cognitive and behavioral side effects of lacosamide in patients with partial     epilepsy and follow them for a period of 24 weeks using a neuropsychological test battery     drawing on tests commonly used and designed to maximize sensitivity to drug effects.      Secondary Objectives:      To determine if any significant changes in cognitive, mood or quality of life measures are     dependent upon changes in seizure severity, neurotoxicity, adverse events, or Lacosamide     dosage.   "
253711|NCT01176253|"     To investigate the use of methylation-specific PCR (MSP) assays to detect human beta     cell-specific gene methylation patterns in serial blood samples drawn from newly diagnosed     Type 1 diabetics.   "
253685|NCT01175993|"     Background:        -  Traumatic brain injury may have a range of effects, from severe and permanent disability          to more subtle functional and cognitive deficits that often go undetected during initial          treatment. To improve treatments and therapies and to provide a uniform quality of care,          more research is needed into different treatments for traumatic brain injury.        -  Exercise has been shown to improve movement and balance in people with strokes, cerebral          palsy, and other conditions that affect the brain, and can improve symptoms of memory          problems or depression. Bright light therapy has also been shown to improve mood in          people with depression. Researchers are interested in studying problems with movement,          balance, thinking, and mood in people with traumatic brain injury. By comparing the          effects of exercise and bright light exposure on brain function, new treatments may be          developed for acute traumatic brain injury.      Objectives:      - To compare the effects of exercise and bright light therapy on the brain function of     individuals with traumatic brain injury.      Eligibility:      - Individuals between 18 and 44 years of age who either have been diagnosed with traumatic     brain injury or are healthy volunteers.      Design:        -  Individuals with traumatic brain injury will have four outpatient evaluation visits at          the clinical center, a 3-month home exercise program, and a 3-month bright light          exposure program at home. Healthy volunteers will have one evaluation visit at the          clinical center.        -  At the first study visit, all participants will have a full physical examination and          medical history. Individuals with traumatic brain injury will also have an eye exam to          determine if it is safe for them to receive light therapy.        -  All participants will have the following initial tests:        -  Tests of walking and movement, including monitoring by a physical therapist; tests to          record joint movement and evaluate muscle function; tests that combine movement,          thinking, and speaking; and balance and reaction time tests.        -  Magnetic resonance imaging scans        -  Tests of thinking and mood, including questionnaires, computerized tests, and simple          action tests.        -  Participants with traumatic brain injury will have separate 3-month sessions of exercise          and bright light therapy, with additional evaluation visits between each 3-month session          and at the end of the study. Between the 3-month sessions, participants will have 1          month with no intervention.        -  Exercise sessions will involve regular workouts on an elliptical machine for 30 minutes          for 5 days a week, and bright light therapy sessions will involve sitting in front of a          light box for 30 minutes for 5 days a week. Participants will keep a journal to monitor          the effects of the therapy.   "
253686|NCT01176006|"     Background:      -DOCK8 deficiency is a genetic disorder that affects the immune system and can lead to severe     recurrent infections and possible death from infections or certain types of cancers,     including blood cancers. A stem cell transplant is a life-saving treatment for this     condition. In this study we are evaluating the efficacy and safety of transplant from     different donor sources for DOCK8 deficiency. The donors that we are using are matched     siblings, matched unrelated donors, and half-matched donors, so called haploidentical related     donors, such as as mothers or fathers or half-matched siblings.      Objectives:      -To determine whether transplant of bone marrow cells from different types of donors corrects     DOCK8 deficiency.      Eligibility:        -  Donors: Healthy individuals between 4 and 60 years of age who are matched with a          recipient.        -  Recipient: Individuals between 5 and 40 years of age who have DOCK8 deficiency, have          suffered one or more life-threatening infections, or have had certain viral related          cancers of cancer and have a stem cell donor.      Design:        -  All participants will be screened with a physical examination and medical history.        -  DONORS:             -  Donors will donate bone marrow cells or blood stem cells. If donating blood stem               cells, donors will receive injections of filgrastim to release stem cells into the               blood. After 5 days of filgrastim injections, donors will have apheresis to donate               stem cells and white blood cells that are present in the blood.             -  Donors who provide the stem cells through bone marrow donation will have their bone               marrow cells harvested in the operating room.        -  RECIPIENTS:             -  Recipients receiving matched related or unrelated donors will receive 4 days of               chemotherapy with busulfan and fludarabine to suppress their immune system and               prepare them for the transplant. Donors receiving haploidentical related donors               will receive two doses of chemotherapy with cyclophosphamide, 5 days of               fludarabine, 3 days of busulfan, and one dose of radiation to suppress their immune               system and prepare them for the transplant.             -  After the initial chemotherapy and radiation, recipients will receive the donated               stem cells as a single infusion. Recipients may also receive white blood cells from               their stem cell donor to encourage acceptance of the stem cells.             -  After the stem cell transplant, recipients will receive two days of a chemotherapy               called cyclophosphamide on day's + 3 and + 4 followed by two drugs tacrolimus and               mycophenolate to prevent graft versus host disease where the donor cells attack the               patient's body. All patients will remain in the hospital for approximately 1 month,               and will be followed with regular visits for up to 3 years with periodic visits               thereafter to evaluate the success of the transplant and any side effects.   "
253687|NCT01176019|"     The purpose of this study is to determine whether an interactive education program for     prenatal testing is effective in improving pregnant women's understanding of and expectations     towards prenatal screening and diagnosis.   "
253688|NCT01176032|"     The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels     of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in     hypertensive patients.   "
253689|NCT01176045|"     The primary objective of this study is to determine how pre & post-operative tear osmolarity     levels relate to rates of dry eye symptoms related to refractive surgery and if differences     exist in patients who are pre-treated with ocular lubricants vs. those treated only     post-operatively.   "
253690|NCT01176058|"     In the treatment of patients with candidemia and/or other forms of invasive candidiasis ,     Anidulafungin is at least as effective and safe as Fluconazole.   "
253691|NCT01176071|"     The investigators hypothesize that early galactomannan and beta-D-glucan features, namely the     height of the initial value at the time of diagnosis and the subsequent rate of marker decay     within the first week(s) following therapy (day 7, day 14) are important factors in     predicting clinical outcome.   "
253692|NCT01176084|"     The purposes of this study are:      To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of     heart health including blood fats, blood clotting factors, inflammatory markers and levels of     body fat.      To investigate the added effect on heart health that regular moderate exercise may have when     combined with a low carbohydrate diet in obese men.   "
253693|NCT01176097|"     The purpose of this study is to investigate the safety and tolerability of AZD5658 following     ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated     dose.   "
253703|NCT01170702|"     Since there have been no published dose-response studies investigating the effective     analgesic dose of ropivacaine for use in a TAP block for post-Cesarean delivery analgesia,     the investigators propose a study primarily examining the effect on 24 hour post-Cesarean     delivery opioid consumption of using either a placebo, 0.25% ropivacaine, 0.5% ropivacaine,     or 0.75% ropivacaine for TAP blocks.   "
253694|NCT01176110|"     It is known that perioperative hypothermia can influence the postoperative outcome     negatively.      The most important complications are cardiac, increased blood loss with need for transfusion     and a significantly increased wound infection rate.      The thermal redistribution after the induction of anesthesia is on of the reasons for     perioperative hypothermia. Another reason is negative heat balance during surgery.      Further negative side effects of hypothermia are an increase of blood viscosity and thus a     higher risk for thrombosis, coagulopathy and thus an increased risk of bleeding.      The aim of the study is to evaluate if patients with a perioperative active thermal     management during an interventional minimal invasive valve replacement have a significantly     higher body temperature at the end of the operation than patients without an active thermal     management. Secondary outcome variables are complication rates, length of mechanical     ventilation and length of ICU treatment.   "
253712|NCT01176266|"     This clinical trial is being conducted to study hypophosphatasia (HPP), a bone disorder     caused by gene mutations or changes. These gene mutations cause low levels of an enzyme     needed to harden bone. The purpose of this study is to test the safety and efficacy of a     study drug called asfotase alfa (human recombinant tissue non-specific alkaline phosphate     fusion protein) to see what effects it has on patients ≤ 5 years of age or less with HPP.   "
253727|NCT01176461|"     This is a pilot phase 1, open-label, single center, multi-dose, dose-escalation study of     BMS-936558 in combination with or without a peptide vaccine.      The purpose of this study is to test the side effects of an investigational vaccine with an     immune booster. Investigators also wish to find out its effects on the patient's immune     system and whether it will shrink their melanoma.   "
253728|NCT01176474|"     The purpose of this study is to test the side effects of an investigational vaccine with an     immune booster, or 2 different boosters together. Investigators also want to find out its     effects on the immune system and whether it will decrease the chance that melanoma will     return.   "
253695|NCT01176123|"     Understanding the effectiveness of Cognitive Behavioral Therapy for trauma-related insomnia     (CBT-I) is important because sleep difficulties often persist after traditional post-trauma     treatments are completed and other trauma-related symptoms have resolved. The objective of     this study is to examine whether CBT-I will equivocally reduce problems falling and staying     asleep (insomnia) related to military-related PTSD when administered in person versus through     telephone therapy to veterans living in rural areas.      Rural populations are at a disadvantage in receiving treatment because of lack of access to     healthcare services. Telemedicine uses technology (e.g., telephones) to provide distance     counseling to the populations who lack access to health care. Thus, telephone-counseling     strategies could provide broad access to interventions for management of trauma-related     insomnia.      Veterans who live more than 30 miles from Veterans Affairs (VA) PTSD specialty services will     be offered participation in this study. All veterans receive 6 weeks of individual CBT-I for     trauma-related insomnia. Participants will be randomized to one of two treatment conditions:     (1) CBT-I in person or (2) CBT-I via telemedicine (defined as receiving treatment by     telephone). No changes will be made to the CBT-I, other than mode of delivery, for the     telemedicine group.      Through this study the investigators hope to demonstrate the effectiveness of CBT-I for     trauma-related insomnia can be delivered effectively to rural veterans in person and via     telemedicine.   "
253696|NCT01176136|"     Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed     childhood disorders, with prevalence rates estimated at 8% (Froehlich et al. 2007). Several     of the primary symptoms of ADHD relate to problems with temporal and materials organization     (i.e. often has difficulty organizing tasks and activities, often loses things, is often     forgetful, and often fails to finish school-work, chores, or duties; APA, 2000). In the     school setting, problems with organization manifest as forgetting to complete or losing     homework assignments, difficulties planning for the completion of long-term projects and     studying for tests, and problems keeping class materials organized. These organizational     difficulties become particularly problematic in middle school and can result in considerable     academic impairment (Evans, Serpell, & White, 2005). Children with ADHD underachieve     academically and are more likely than their peers to receive failing grades, be retained and     to drop out of school (Barkley, Fischer, Edelbrock, & Smallish, 1990).      Given the relationship between temporal and materials organization and poor school     performance, it is clear there is a need for interventions to address these difficulties. We     recently sought to address this need by completing a small randomized trial of an     organizational skills intervention for children with ADHD (Langberg, Epstein, Urbanowicz,     Simon, & Graham, (2008). The intervention was highly effective in improving materials     organization and homework management and resulted in significant improvements in homework     problems and grade point average. These results demonstrate the considerable promise of     organizational skills interventions for children with ADHD. However, the Langberg et al.     intervention was implemented as an after-school program operated by research staff with     minimal involvement from school personnel. In order to promote the widespread adoption of     interventions that address the organizational skills deficits of children with ADHD, the     intervention must be feasible for school counselors and psychologists to implement within the     time constraints of a typical school day. Accordingly, the primary goal of this study is to     adapt and refine the existing intervention protocol (Langberg et al., 2008) to create a     product that is highly acceptable to parents, children, teachers, school counselors and     school psychologists and is feasible for school personnel to implement during the school day.      In Phase I of the proposed research, middle school counselors, psychologists, teachers,     middle school students with ADHD and their parents will consult with the intervention     developers to modify the after-school treatment protocol for in-school implementation. An     intervention protocol will be developed. The intervention will be piloted with ten children     in order to identify barriers to implementation. Measures of treatment fidelity, skills     acquisition, and satisfaction will be completed. These data will inform additional     modifications of the protocol and further improve feasibility/acceptability of the     intervention procedures.      In Phase II of the study, school counselors/psychologists from at least four separate school     districts will implement the protocol developed in Phase I. Using a waitlist control design,     sixty children with ADHD in grades 6, 7, and 8 will receive the intervention. Organizational     skills, grade point average, and academic impairment will be evaluated at baseline, post     intervention and at 8-week follow-up. After implementing the intervention, all participants     (i.e., teachers, counselors, psychologists, children and parents) will participate in a     series of focus groups and will complete intervention satisfaction questionnaires. These data     will inform final revisions to the intervention protocol. The resulting product will be an     intervention that targets organizational skills in children with ADHD that has potential for     widespread school-based dissemination. The final intervention protocol and effect size     estimates from the proposed research will lay the foundation for an IES Goal III test of     efficacy.      The specific aims of the project are as follows:        1. Utilize the existing organizational skills intervention protocol (Langberg et al. in          press), focus group and case study data to develop an empirically and clinically          informed manualized temporal and materials organization intervention for middle school          children with ADHD aimed at reducing academic impairment (Phase I).        2. Refine and finalize the intervention protocol through a waitlist control trial (N=60) in          a minimum of four diverse school districts, collection of clinical outcomes and          completion of follow-up focus groups to assess satisfaction, feasibility, and          acceptability (Phase II).   "
253697|NCT01176149|"     The aim of this pilot study is to evaluate the validity and feasibility of an educational     approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely     changes in therapy, when needed.   "
253698|NCT01176162|"     In the neonatal period, the human kidney is characterized by a functional immaturity     responsible for an impaired ability to regulate water and sodium homeostasis, which is     exacerbated by prematurity. This altered sodium handling could be related to a partial renal     aldosterone resistance. Renal sodium reabsorption and potassium excretion are mainly     controlled by aldosterone, after binding to the mineralocorticoid receptor (MR). The     investigators have analyzed MR expression throughout human and mouse renal development, and     the investigators found a weak MR expression at birth. The investigators have conducted a     pilot study in full-term newborns, which confirmed a partial neonatal aldosterone resistance.     This study also highlighted that urinary aldosterone is the best index to accurately assess     aldosterone sensitivity at birth.   "
253699|NCT01176175|"     Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the     minimum effective dose of progesterone microspheres suspension, which administered by weekly     intramuscular injection, will be able to induce transformation from a proliferative     endometrium to a secretory endometrium.      Study design: Randomized, controlled, open-label, parallel, dose-response clinical trial.      Sites: 1 Subjects: 48 postmenopausal women.   "
253700|NCT01176188|"     Children who become critically ill and require Pediatric Intensive Care Unit     (PICU)hospitalization may develop negative psychological outcomes following discharge. This     pilot study will test a nursing intervention that seeks to promote child comfort, sleep and     psychological well-being during and following PICU hospitalization.      Study objectives are to:        1. test the feasibility and acceptability of a PICU comfort care intervention that can be          administered by nursing staff        2. examine the feasibility and acceptability of data collection procedures        3. pilot test outcome measures        4. determine effect sizes to inform sample size calculation for a future multi-centred          randomized controlled trial (RCT).      The intervention will take place in the PICU, and consists of a parental soothing activity     followed by a quiet period in which earmuffs are placed over the child's ears to block noise.     Children's sleep time and comfort level will be monitored in the PICU, and the investigators     will follow them for 3 months post-discharge to examine the effects of the intervention on     psychological well-being.   "
253701|NCT01170676|"     This is a research study that compares the effectiveness of a web-based program (known as     Puff City) and another web-based program (of internet sites such as the American Lung     Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key     asthma management issues among rural youth:        1. Improving adherence to asthma controller medication use;        2. Improving compliance of carrying a rescue inhaler at all times for use at the first sign          of asthma symptoms;        3. Improving inhaler technique;        4. Smoking reduction or cessation in those who are smokers; and        5. Avoidance of second-hand smoke exposure.   "
253713|NCT01176279|"     The technique of blood samples extraction from the radial artery through an arterial catheter     with a 3-way stopcock and automated washing with valve of fast flow is better than the one     carried out through a fixed reusable arterial blood sample syringe and its manual washing     because it shows a minor incidence of the complications originated from technical     manipulation as infection, pseudo-aneurysm, ischemia or thrombosis of radial artery or     obstruction of the catheter.      The purpose of this study is to evaluate the efficacy, in terms of adverse effects, of blood     samples obtention using an arterial catheter with needless connector closed system or an     arterial catheter with an arterial blood sample syringe.      Also a second purpose is to compare once a day (at the same time) the values of glycose blood     levels between bedside glucometer determination of arterial catheter extraction and capillar     puncture, and lab determination of glycose from venous puncture, in order to determinate     fluctuation in glycose levels due to peripherical hypoperfusion or to vasoactive drugs     received by these in-intensive care unit patients.   "
253714|NCT01176292|"     The goal of this study is to determine if the rotating platform high flex design provides     improved flexion compared to the standard rotating platform TKA.   "
253715|NCT01176305|"     The purpose of this study is to describe the incidence of thromboembolic events in relation     to pregnancy and when in pregnancy and the puerperal period.   "
253704|NCT01170715|"     Psoriasis is a chronic relapsing prevalent inflammatory disease affecting 2-4% of the world's     population. Severe psoriasis is a disabling disease affecting the physical and emotional well     being of patients, and its effect on quality of life is similar to that seen with other major     medical diseases such as diabetes, rheumatoid arthritis, and cancer. Lately, it is     increasingly being recognized that psoriasis is not merely a skin disease but is probably     associated with other co-morbidities such as psoriatic arthritis, Crohn's disease, the     metabolic syndrome and cardio-vascular diseases (CVD). The metabolic syndrome is a     combination of diabetes mellitus type II (or insulin resistance), hypertension, central     obesity, and combined hyperlipidemia (elevated LDL; decreased HDL; elevated triglycerides).     As the literature linking psoriasis and the metabolic syndrome expands, also reports of an     increased rate of CVD mortality in psoriasis patients accumulates. These data emphasize that     metabolic dysregulations are the leading risk factors for occlusive vascular events and early     death in patients with severe psoriasis. Progress in understanding the pathogenesis of these     apparently diverse diseases has discovered that low-grade systemic inflammation might be the     common physiological pathway that may provide the biological plausibility of the associations     discovered in the epidemiological studies. Since some of these co-morbidities often become     clinically apparent years after the onset of psoriasis we assume that controlling systemic     inflammation might prevent or reverse some of these co-morbidities.      Presently there is no study in psoriasis that shows that a systemic co-morbidity can be     prevented or treated by reversing skin inflammation.   "
253705|NCT01170728|"     This study is a multi-center study that will assess the efficacy and safety of suture     fixation of the Virtue® Male Sling.   "
253706|NCT01170741|"     This study will draw from proven interventions to refine and pilot test a cue card driven     computer-assisted intervention, along with HIV/STI testing, that will be tailored to each     participant's demographic characteristics, risk behaviors, and biological test results. The     specific aims of the proposed study are:        1. To refine a cue card driven computer-assisted risk reduction intervention that will be          tailored to each participant's demographic characteristics (e.g., gender, ethnicity),          risk behaviors, and biological test results (HIV, hepatitis B and C, syphilis and          herpes).        2. To pilot test the tailored intervention's effects on sexual risk behaviors (e.g.,          frequency of unprotected sex, condom use), drug use during sex and injection risk          behaviors (e.g., direct syringe sharing, indirect sharing practices) using a two-group          randomized design that compares the tailored intervention with a delayed treatment          control condition.        3. To assess the feasibility and acceptability of the tailored intervention in a rural          setting.   "
253707|NCT01176201|"     This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and     Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.   "
253708|NCT01176214|"     Background:      One third of all ICH patients require intubation and mechanical ventilation and 1/3 of all     ventilated patients require tracheostomy (i.e.≈10% of all ICH patients require tracheostomy).     As shown previously, predisposing factors for tracheostomy are hematoma volume, hemorrhage     location, presence of intraventricular hemorrhage (IVH), and occlusive hydrocephalus as well     as presence of COPD (Huttner HB et al 2006 CVD).      Sustained restricted vigilance and impaired consciousness after ICH is likely to result in     failure of extubation, raise in incidence of ventilator-associated pneumonia, increased     amount of sedative drugs and prolonged duration of neurocritical care.      Hence an early tracheostomy may be beneficial in terms of reduced duration of mechanical     ventilation.      Basic hypothesis:      Compared to patients with conventional (late) tracheostomy between day 12 - 14, patients     with early tracheostomy within 72h after admission will have:        -  shorter cumulative time of mechanical ventilation        -  less incidence of ventilator-associated pneumonia        -  less consumption of sedative drugs        -  shorter duration of stay in neurocritical care unit      Randomization:      Consecutive eligible patients are randomly assigned to Either early tracheostomy within 72h     after hospital admission Or late tracheostomy (= control group; undergoing conventional     tracheostomy between day 12 - 14 if extubation fails) Both groups receive plastic     tracheostomy   "
253709|NCT01176227|"     The Canadian College of Naturopathic Medicine is conducting a research study on Irritable     Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring     gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is     characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and     bloating.      The medicines that are currently used to help people with IBS are not as effective as we     would like them to be. These medicines are usually only prescribed to reduce the pain of IBS     and not actually treat the disorder itself. Recently, scientists have found that probiotics     (beneficial bacteria that live inside humans) may help reduce the painful symptoms and     diarrhea that are part of IBS.      This research is being conducted to determine whether this particular combination of three     probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium     longum) will reduce the symptoms of IBS.   "
253710|NCT01176240|"     This is a study to evaluate the effects of an investigational drug, Droxidopa, in     participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's     disease. Droxidopa is being studied to determine the effects on blood pressure changes upon     standing up (orthostatic challenge). Symptoms and activity measurements, including patient     reported falls, will be evaluated to determine the effectiveness of the study drug.      Symptoms of NOH may include any of the following:        -  Dizziness, light-headedness, feeling faint or feeling like you may blackout        -  Problems with vision (blurring, seeing spots, tunnel vision, etc.)        -  Weakness        -  Fatigue        -  Trouble concentrating        -  Head & neck discomfort (the coat hanger syndrome)        -  Difficulty standing for a short time or a long time        -  Trouble walking for a short time or a long time      The study duration is a maximum of approximately 14 weeks including up to 2 weeks for     screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and     a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow     approximately 211 randomized patients. An extension study is also available to continue     treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored     by Chelsea Therapeutics and is enrolling by invitation only.   "
253716|NCT01176318|"     This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial.      60 patients to be included who are adult patients admitted to hospital with a clinical     diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Acute     exacerbation of COPD will be defined as sustained worsening of the patient's condition with     an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence,     necessitating a change in regular medication.      The primary objective of this study is to evaluate the effectiveness of standard care plus     erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder)     measured from baseline (Day 0) and at Day 5 of treatment, compared with standard care plus     placebo.   "
253717|NCT01176331|"     In a retrospective study, a combined 20 and 23-gauge pars plana vitrectomy procedure was     performed in 21 eyes for various indications and proposed as a transition procedure to     23-gauge transconjunctival vitrectomy. Through use of combination of procedures postoperative     complications, surgical trauma and healing time was decreased; operating time was reduced;     costs were decreased.   "
253718|NCT01176344|"     Observational evidence suggests that vitamin D deficiency may have a role in the causes of     osteoarthritis (OA) and there are biologically plausible mechanisms to explain this. There     is, however, no evidence which shows that intervening with vitamin D supplementation can slow     the progression of OA. This study is to determine if vitamin D supplementation can reduce     knee pain and slow knee cartilage loss in OA patients comparing with a placebo. Use of MRI     will provide sensitive measures of knee OA changes.   "
253719|NCT01176357|"     Coronary artery disease (CAD), the most common type of heart disease, is caused by hardening     of the arteries, or atherosclerosis that is an inflammatory process in which immune     mechanisms interact with metabolic risk factors to initiate, propagate, and activate lesions     in the arterial trees. Epidemiological studies have found that increased cardiovascular risks     are associated with increased levels of inflammatory cytokines (eg, interleukin-6 [IL-6] and     tumor necrosis factor-alpha[TNF-alpha]) or their hepatic product, C-reactive protein (CRP).     Higher expression of interleukin-Ibeta(IL-1beta),IL-6, monocyte chemotactic protein-1     (MCP-1), and TNF-alpha were observed in epicardial adipose tissues in patients with CAD.     These findings suggested that the pericoronary tissues could be a source of inflammatory     mediators or act as paracrine that lead to vascular inflammation on CAD pathogenesis.     However, adiponectin, a kind of adipocytokine, produced and secreted exclusively by adipose     tissue, has been reported to have a variety of anti-inflammatory functions against     atherosclerosis, resulting in risk reduction for incidence of CAD events. It remains unclear     whether adiponectin and inflammatory mediators in mediastinal adipose tissue contribute to     CAD. We therefore aim to analyze the expression of adiponectin and inflammatory mediators in     mediastinal adipose tissue between patients with CAD and with valve diseases, and to     correlate these parameters with clinical atherosclerotic risks, medications (statins or     antiplatelet), and blood sugar.   "
253720|NCT01176370|"     The C-Pulse Study is evaluating the safety and performance of a new product for the treatment     of heart failure. The product is designed to help reduce the symptoms of heart failure and     help patients function better with daily activities. The study evaluates multiple measures of     heart function and whether the patient's quality of life has been improved since the device     implant. The patient will have several visits after the device implant to assess how well     they are doing and to monitor any safety concerns.   "
253721|NCT01176383|"     Professor RP Young (Associate Professor of Medicine and Molecular Medicine, School of     Biological Sciences, University of Auckland) and his team have developed a reliable genetic     test Respiragene based on 20 single nucleotide polymorphisms that can be used (together     with details of personal and family history) to calculate a smoker's lifetime risk of     developing lung cancer. The expectation is that whatever the score (estimated lifetime risk     will vary from 5% to 50%) the result will counter optimism bias of the smoker and encourage     smoking cessation and this assumption is supported by previous research on similar tests and     smoking cessation. The investigators plan to recruit two groups of subjects for smoking     cessation but only one group will have the Respiragene test. Eight weekly smoking cessation     sessions will be carried out at a Surrey primary care medical centre and will follow the     usual format for National Health Service smoking cessation clinics using Champix     (varenicline), counselling and the carbon monoxide breath meter but with added: evaluation     questionnaires, fagerstrom nicotine addiction score, salivary cotinine (metabolite of     nicotine) test. The main outcome measures will be estimation of smoking cessation at 4 weeks     and six months after the completion of the seven smoking cessation sessions. Successful     smoking cessation has to be confirmed by negative salivary cotinine at 4 weeks and six months     and questionnaires will be used to estimate the influence of the Respiragene test compared     with standard procedures such as counselling and the carbon monoxide breath readings.   "
253745|NCT01179321|"     The purpose of this study is to determine the impact of malnutrition screening and nutrition     intervention on acute aged care patient outcomes.   "
253722|NCT01176396|"     The goal of this project is to create a Practice Based Research Network with 30 researcher     dentists calibrated on the administration of a caries risk assessment and the treatment     modalities recommended based on the caries risk assessment results (Caries Management by Risk     Assessment - CAMBRA), and to conduct a 2-year CAMBRA study in those dental offices.     Participating dentists will be a mix of general practitioners and pediatric dentists selected     from private practice, part time university faculty, large group practices, or community     clinics. Participating practices will collect baseline data and patient progress and report     on patient acceptance and compliance, and the effectiveness of treatment.      The program's duration is anticipated to be approximately four years. Year one will be     dedicated to program, protocol and evaluation design, and recruitment, selection and     calibration of researcher dentists. Years two and three will be the research and data     collection time period, and year four will be dedicated to evaluation.   "
253723|NCT01176409|"     The purpose of this study is to compare the levels of immune and inflammatory markers among     HIV-1, HSV-2 co-infected adults achieving plasma HIV RNA suppression to <50 copies/mL,     between those randomized to valacyclovir and placebo, over a twelve-week intervention period.   "
253724|NCT01176422|"     Researchers hope to determine if the DNA is shortened in your body and determine if there is     an increase in the protein that shortens DNA called telomerase.   "
253982|NCT01176630|"     The study is a survey to answer the specific question, What is the prevalence of metabolic     syndrome in maintenance hemodialysis patients? Metabolic syndrome is a cluster of conditions     that increase an individual's risk for developing cardiovascular disease and diabetes.   "
253729|NCT01176487|"     RATIONALE: 3-dimensional conformal radiation therapy may lessen side effects caused by     palliative radiation therapy and improve the quality of life of patients with lung cancer.      PURPOSE: This clinical trial is studying how well 3-dimensional conformal radiation therapy     works in reducing the side effects of palliative radiation in patients with lung cancer.   "
253730|NCT01176500|"     Background:        -  Fluciclatide is a small cyclic peptide containing the RGD tri-peptide, which          preferentially binds with high affinity to alpha(v)beta(3) integrins, which are          up-regulated in and may regulate angiogenesis.        -  [18F]Fluciclatide is a new radiopharmaceutical developed for PET imaging        -  Changes in [18F]fluciclatide uptake will be evaluated before and after treatment of          patients with targeted antiangiogenic drugs      Objectives:      Primary        -  To determine tumor uptake and retention of [18F]fluciclatide before and after 1 cycle of          treatment with targeted anti-angiogenic therapy        -  Secondary        -  To assess the safety of multiple intravenous (IV) administrations of Fluciclatide [18F]          Injection in subjects with solid tumors        -  To obtain preliminary data on the relationships between [18F]fluciclatide as a          pharmacodynamic marker and standard of care imaging markers of clinical response (e.g.          contrast-enhanced (CE) static computed tomography (CT), bone scintigraphy, FDG-PET),          obtained as part of routine clinical follow-up as specified in the referring protocols,          as well as any optional imaging performed      Eligibility:        -  Patients greater than or equal to 18 years, with documented malignancy, and solid tumor          greater than or equal to 1 cm outside of the liver, who are scheduled to enroll in an          NCI therapy protocol using one of the anti-angiogenic agents described in the full          protocol        -  Platelet count greater than 75,000 x 10(6)/L, hemoglobin greater than 9g/dL, prothrombin          time (PT) and aPTT less than 2 times normal limits.        -  The subject has not received any targeted anti-angiogenic agents within 60 days prior to          pre-treatment (baseline) [18F]fluciclatide administration      Design:      This study is intended to obtain preliminary data on the uptake and retention of     [18F]fluciclatide before and after anti-angiogenic therapy. This will enable optimization of     the imaging protocol, identification of the most relevant imaging parameters, and allow for     calculation of the number patients required to power a larger study to assess the utility of     PET imaging with [18F]fluciclatide as a pharmacodynamic biomarker in the context of targeted     anti-angiogenic therapies. We expect to enroll 30 evaluable patients in this single center     study. Subjects will undergo at least two [18F]fluciclatide PET/CT imaging studies, one     pre-therapy and one following completion of 1 cycle of chemotherapy. An optional early     post-therapy (2-7 days post therapy commencement) [18F]fluciclatide PET/CT may be performed.     The magnitude of [18F]fluciclatide uptake on the pre- and post- treatment PET/CT studies will     be evaluated to determine if there is a measureable difference in uptake. Data from the     subject's referring therapy protocol will be reviewed for up to one year. An optional DCE-MRI     scans of the target lesion may also be performed.   "
253731|NCT01176513|"     Background:      - GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells. Researchers     are interested in combining the drug with a small amount of radioactive material to allow     prostate cancer lesions to appear more clearly on imaging scans. Researchers are also     interested in determining whether the combination can help make cancer cells in pelvic lymph     nodes easier to detect through imaging studies. GE-148 (18F) will be used to examine     individuals who are scheduled to have surgery on their prostate cancer.      Objectives:      - To evaluate the effectiveness of GE-148 (18F) in detecting prostate cancer and cancer cells     in pelvic lymph nodes using positron emission tomography and magnetic resonance imaging     scanning.      Eligibility:      - Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled     to have prostate removal surgery.      Design:        -  Participants will be screened with a physical examination, medical history, blood tests,          and imaging studies.        -  Participants will have magnetic resonance imaging (MRI) and positron emission tomography          (PET) scans with GE-148 (18F) prior to their scheduled surgery. The MRI and PET scans          may be performed on the same day or on different days, depending on the schedule set by          the study researchers.        -  Tissue samples taken during prostate removal surgery, including prostate tissue and          pelvic lymph nodes, will be collected for further study of the effectiveness of GE-148          (18F).   "
253732|NCT01176526|"     Social comparisons may function as a coping strategy, but their role in coping and quality of     life has not been well characterized. The purpose of the current study is to investigate the     relationships between cognitive appraisals; coping strategies; social comparisons; and     quality of life among men with prostate cancer. The conceptual framework for this study is     drawn from Festinger s Social Comparison Theory, Lazarus and Folkman s Transactional Model of     Stress and Coping, and Mishel s Uncertainty in Illness Theory. A cancer diagnosis is     accompanied by uncertainty about how cancer will affect one s life. Theory and empirical data     suggest that in conditions of uncertainty, coping affects adjustment to a condition. Social     comparisons have been postulated to be more prevalent in uncertain situations. Because little     is known about how social comparisons operate, participants in this study will be recruited     exclusively from prostate cancer support groups. Support groups provide a context in which     individuals are likely to make social comparisons and to be cognizant of these comparisons.     Prostate cancer provides a model of a common, chronic condition with complex etiology.     Prostate cancer treatment may cause sexual, urinary, and bowel side effects, which may affect     patients quality of life and elicit attempts to cope. One way of managing the prostate cancer     experience may be to compare oneself to others who are doing better or worse than oneself on     relevant dimensions. The interpretation of social comparisons may positively or negatively     affect one s perceived quality of life. There have been no studies among prostate cancer     patients that have quantitatively measured the use of social comparisons. There is also a     paucity of research in this population regarding the predictors of coping strategies and the     predictors of quality of life across multiple domains. This study will use a cross-sectional,     mixed methods survey to investigate relationships between cognitive appraisals, coping, and     quality of life and to qualitatively explore social comparisons among men with prostate     cancer. Participants may complete the survey on paper or online. The primary outcomes are the     use of coping strategies, including social comparisons, and quality of life. Individuals with     a personal or family history of prostate cancer are currently seen by genetic counselors as     part of research studies investigating the genetic basis of prostate cancer. If relationships     are demonstrated between the social comparisons and quality of life, genetic counselors may     want to assess patients social comparisons to evaluate how patients are coping with their     condition.   "
253892|NCT01178086|"     This observational study will assess the therapeutic efficiency, the treatment schedules and     handling procedures, and the safety profile of MabThera/Rituxan (rituximab) in routine care     in patients with chronic lymphocytic leukemia. Data from patients will be collected for a     total of 24 months.   "
253733|NCT01179165|"     The purpose of this study is to investigate the prevalence of cardiac disease/coronary artery     disease and diagnostic yield of different non-invasive methods in patients with type 2     diabetes 40-75 years of age at examination. Exercise tests, Doppler echocardiographic     examination with Tissue Velocity Imaging, stress Echocardiography, transthoracic Doppler of     coronary arteries with coronary flow reserve, and cardiac MRI with late enhancement at rest,     and perfusion after vasodilatation stress will be used in the study. A subpopulation will in     addition measure forearm vasodilation(FMD) and CFR before and after 4 months of exercise     training.   "
253734|NCT01179178|"     The investigators have taken part in the development of simple muscle function tests and     studied physical training and energy turnover in patients with chronic obstructive pulmonary     disease, COPD. The investigators have found that muscle wasting in COPD is related to poor     prognosis and that physical training might lead to improved, less energy-demanding muscle     function. Elderly subjects also suffer from muscle wasting that leads to frailty, poor     autonomy and, secondarily, fractures. In the planned study the investigators will validate     simple muscle function tests (hand grip strength, heel rise test, voluntary quadriceps muscle     strength, 30 m walking test and balance tests) in both groups by relating them to an     involuntary, magnet stimulated, test of quadriceps force, HRQL, tests of body composition     (impedance, DXA) and recordings of physical activity. The relation between food intake,     systemic inflammation, muscle mass and function will be analysed.      The study has been ethically approved and started in COPD patients and will be expanded to a     representative sample of elderly.      Simple, evaluated muscle function tests applied in primary care may be used for early     detection of muscle dysfunction in COPD patients and elderly so that early intervention     against impaired muscle function can be started. Analyses of food intake and of inflammatory     markers might identify factors of special importance for muscle dysfunction, which eventually     might lead to improved dietary therapy and pharmacological interventions.   "
253735|NCT01179191|"     The purpose of the research study is to find out if opioid dependent chronic pain patients     who are judged by their physician to be eligible to change their current opioid medicine and     to participate in this study can be successfully adjusted to a stable dose of EMBEDA     (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's     risk for prescription opioid abuse, misuse and diversion.   "
253736|NCT01179204|"     In this consecutive, prospective cohort study trial the investigators evaluate if     preoperative pain response upon heat stimulation is predictive for acute and subacute     postoperative pain after total knee arthroplasty.   "
253737|NCT01179217|"     The purpose of this research is to evaluate the effects of L-glutamine as a therapy for     Sickle Cell Anemia or Sickle ß0 Thalassemia as evaluated by the number of occurrences of     sickle cell crises.   "
253738|NCT01179230|"     Many stress tests being done today have two parts, the stress test and the pictures of your     heart. The investigators are comparing a newer technique to obtain the pictures (PET imaging)     to the standard method (SPECT imaging). However, it is not known if the new test is better     than the old test. It is important to have a standard to compare these tests to, and that is     why people who will be getting a cardiac catheterization are being asked to participate. The     information about your arteries from the cardiac catheterization will be used to judge which     stress test is better. The investigators hypothesize that the newer method (PET imaging) will     be more accurate than the old method (SPECT) in detecting heart disease.   "
253739|NCT01179243|"     Recent research has focused on the investigation of sublingual microcirculatory alterations     in different patient categories, like cardiac surgery and sepsis. The microcirculation plays     a pivotal role in tissue oxygenation and can be non invasively visualized by sidestream dark     field (SDF) imaging.      The objective is to carry out a international multi center study to investigate the     prevalence of microcirculatory alterations in intensive care patients. Up to the present     time, a comprehensive prevalence study like this has not been carried out.   "
253740|NCT01179256|"     Curcumin has antioxidant properties and in animal models has numerous molecular targets, many     of which are intracellular, such as transcription factors AP-1 and NF. As such, it inhibits     the secretion of both pro-inflammatory (TNF-, IL-6) and anti-inflammatory (IL-10) cytokines,     possibly by inhibiting transcription factors such as nuclear factor-B (NF-B) and activator     protein-1 (AP-1) (Wong et al).   "
253741|NCT01179269|"     Lung cancer is the leading cause of cancer worldwide with approximately 1.2 million new cases     each year. Non-small cell lung cancer (NSCLC) accounts for greater than 80% of all lung     carcinomas in Western countries. Surgical resection is the treatment of choice for patients     with early stage disease (Stage I and II), but at least 50% of these patients will relapse     locally and/or develop distant metastases. Furthermore, 70% of patients with NSCLC are     non-resectable at the time of their diagnosis due to either locally advanced or metastatic     disease. The long-term prognosis for patients with NSCLC remains poor with the overall 5-year     survival rate less than 15%. The low survival rate may be attributed to the high incidence of     unresectable disease at presentation and the inability of systemic therapy to cure metastatic     disease. There is a clear need for improvement in the treatment of NSCLC.   "
253742|NCT01179282|"     Subjects who have a clinical history of perennial rhinitis symptoms associated with dust     exposure or not associated with other perennial allergens, will have a positive challenge     with Dermatophagoides pteronyssinus. Subjects will be ppt negative and intradermal skin test     positive to Dust p Challenges will be performed with placebo or Dp extract three times daily     each for 2 weeks.      Primary endpoint after nasal challenge with Dust p Mean Symptom score increase by greater     than or equal to 2 from baseline. Secondary Outcomes Mean decrease in PNIF by greater than     15percent from baseline. Mean increase in nasal lavage PGD2 and ECP by greater than 15percent     from baseline levels.      Correlation between the orthogonol diameter of the wheal and flare of the intradermal skin     test and the degree of symptom worsening during the nasal challenge.      These results will provide evidence for the continued use of the intradermal skin test in     evaluating allergic rhinitis.   "
253743|NCT01179295|"     This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral     BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles     in Japanese patients with advanced solid tumors   "
253744|NCT01179308|"     Test the effect of combined regiona/general anesthesia on lung cancer recurrence compared to     general anesthesia alone.   "
253746|NCT01179334|"     Pulmonary Arterial Hypertension (PAH) is a severe progressive disease with a high mortality.     Although several drugs are available for the treatment of PAH none offer a cure, therefore     there is still a high medical need for new treatments.      Soluble guanylate cyclase (sGC) is one of the chemicals involved in the pathways controlling     vascular tone, which is impaired in patients with PAH. This causes constriction and     thickening of the blood vessels wall in the lungs and increase of blood pressure in the     lungs. This can lead to the very debilitating symptoms of PAH such as tiredness, shortness of     breath on exertion, collapse and often the inability of the patient to perform their daily     life activities.      Inhalation of Nitric Oxide, which activates sGC is used to treat PAH, but its effect wears     off as soon as inhalation stops. Direct stimulation of sGC using this new compound Riociguat     may be a new approach for the treatment of PAH.      The phosphodiesterase 5 (PDE5)-inhibitor Sildenafil is one of licensed treatments for PAH.     The Patent Plus is a double-blind, placebo-controlled safety study, designed to investigate     the effect of Riociguat on blood pressure in patients with PAH when given in combination with     Sildenafil.   "
253747|NCT01179347|"     To date, there have been no formal clinical studies completed using tiotropium in CF     patients. While there is a large body of evidence demonstrating the efficacy and safety of     tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little     is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis.     Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic     tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric     and adult CF. The phase III trial (205.438) is a part of the approved Paediatric     Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.   "
253748|NCT01179360|"     To determine if combined [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission     tomography/computed tomography (PET/CT) is performant enough with respect to detecting     residual lymph node involvement after chemoradiation in order to omit planned neck     dissections in patients with locally advanced potentially operable, N2 and N3 head and neck     squamous cell carcinoma (HNSCC).      Primary study hypothesis: The lower bound of the 95% confidence interval (CI) of the negative     predictive value (NPV) of FDG PET/CT to detect residual malignant lymph node involvement at     12 weeks after completing chemoradiation will exceed 85%.   "
253749|NCT01179373|"     The primary objective of this trial is to assess the ability of Transcranial Magnetic     Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training,     to improve cognitive performance in patients with Alzheimer's disease which received drug     treatment. This study is a single-center, double-blind 4 months duration trial.   "
253750|NCT01179386|"     Adolescents suffering of ADHD may have impaired driving performance. The investigators would     like to check the differences in driving performance in young adults(aged: 15-18 years) with     ADHD by driving simulator and seat pressure mapping with and without methylphenidate     medication.   "
253751|NCT01179399|"     Overview of Study Design: This is a phase 1, multicenter, open-label, multiple-dose,     dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK),     and antitumor activity of TAK-960 in patients with advanced nonhematologic malignancies. This     study will be the first to administer TAK-960 to humans. The patient population will consist     of adults with a nonhematologic malignancy for which standard treatment is no longer     effective or does not offer curative or life-prolonging potential, or for which no standard     treatment is available.   "
253752|NCT01179412|"     The purpose of this study is to determine the outcomes of treating epidemic     keratoconjunctivitis with 2% povidone-iodine.   "
253753|NCT01179425|"     The purpose of this study is to explore sex differences in cognitive functioning and     responses to marijuana-related items, and to determine whether stress impacts these measures.      Hypothesis 1: Attentional bias will be greater for marijuana cues in male marijuana-dependent     subjects relative to female marijuana-dependent or non-dependent male controls.      Hypothesis 2: Marijuana-dependent females will exhibit greater stress-induced changes in     attentional bias and cognitive functioning than marijuana-dependent males.   "
253754|NCT01179438|"     Dexmedetomidine administration for minor procedure, such as extracorporeal shock wave     lithotripsy, provides good quality of sedation and analgesia. Dexmedetomidine is a highly     selective α2-adrenergic receptor agonist which causes sedative effects and reduces opioid     requirements in the perioperative period. Extracorporeal shock wave lithotripsy may cause     pain and result in tachycardia and vasoconstriction-related hypertension. Surgical or     procedural stress may induce inflammation and it may cause further microthrombosis. Both     vasoconstriction and microthrombosis will alter the microcirculatory status. Dysfunction of     microcirculation may impair tissue perfusion and result in organ dysfunction. Dexmedetomidine     may induce vasodilation by slow intravenous infusion for sedation. Dexmedetomidine may also     reduce inflammation. After reviewing the literature, the investigators found that the effect     of dexmedetomidine on microcirculation was not well investigated. By application of the     non-invasive technique of sidestream dark field imaging, the investigators can investigate     the vessel density, percentage of perfused vessels, and microvascular flow index on     sublingual vessels.      The goal of this study is to identify the effect of dexmedetomidine on sublingual     microcirculation in patient undergoing extracorporeal shock wave lithotripsy.   "
253755|NCT01179451|"     The purpose of this study is to determine whether there is late cardial involvement in     children diagnosed with post streptococcal reactive arthritis after discontinuation of     prophylactic antibiotic therapy.   "
253756|NCT01179464|"     The purpose of this study is to investigate the effects of aminobiphosphonate treatment on     the phenotype and function of circulating Vgamma9Vdelta2-T cells and to determine whether     these effects are inhibited by simultaneous treatment with statins.   "
253757|NCT01179477|"     The purpose of this multicenter post-approval study is to evaluate the acute and chronic     performance of the QuickFlex® μ 1258T left ventricular lead.   "
253758|NCT01179490|"     The study objectives of this study are to determine the effects, safety, and pharmacokinetics     of bendamustine for multiple myeloma to a regimen of bendamustine and prednisolone.   "
253893|NCT01178099|"     The purpose of this study is to measure the exposure to prasugrel's active metabolite and the     pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD).   "
253759|NCT01179503|"     A growing body of evidence suggests that vitamin D status is important in biologic processes     involved in the maintenance of physical function. To advance the investigators understanding     of the role of vitamin D in physical function, the investigators will conduct a feasibility     pilot study to collect key information to help design a full-scale randomized trial to     determine whether vitamin D supplementation will delay declines in physical function. The     primary goals of the pilot study are to determine cost-effective strategies for identifying     persons at high risk for functional decline with insufficient vitamin D levels, determine the     serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient     vitamin D levels, and provide preliminary data of key functional measures (balance, physical     performance and muscle power) for the future larger study design. A secondary goal is to     begin to examine potential mechanisms by which vitamin D supplementation may enhance physical     performance by exploring the effects of vitamin D supplementation on changes in skeletal     muscle gene expression.   "
253760|NCT01179516|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of     vortioxetine, once daily (QD), compared with placebo in adults with major depressive     disorder.   "
253761|NCT01179529|"     This study aims at evaluating the therapeutic potential of omalizumab in atopic dermatitis,     and to work out biomarkers predictive of treatment response.   "
253762|NCT01179542|"     The involvement of eukaryotic translation initiation factor 4E (eIF4E) in human placental     implantation and in the pathological pregnancies: preeclampsia and IUGR.   "
253789|NCT01176734|"     The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the     afferent branches of the nervus vagus around the human ear. The clinical trial is designed as     a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve     stimulation.   "
253983|NCT01176643|"     The purpose of this study is to test the effects of a modified yoga program in persons with     SLE.   "
253763|NCT01179555|"     Pt. 1 Diabetic retinopathy is a common eye condition among diabetic adults and can lead to     severe vision impairment and even blindness. African Americans are more likely to have vision     loss from diabetic retinopathy due to a variety of factors, including cultural barriers to     care. The investigators aim to increase the rates of eye exams in diabetic African American     adults by providing culturally relevant home-based interventions. These interventions will     increase the knowledge about diabetes and the eyes and the awareness of ocular risks due to     diabetes.      206 African American adults, over the age of 65, with diabetes will be recruited from primary     care clinics at Thomas Jefferson and Temple University. Eligible patients who consent to     participate will have baseline information taken about medical and ocular history,     understanding of diabetes and a hemoglobin A1C level obtained. The subjects will then be     randomized to one of two treatment conditions: Behavioral Activation or Supportive Therapy,     each of which will be delivered over 4 sessions. Behavioral Activation will consist of     educational materials, referral assistance for eye clinics, and addressing patient specific     barriers to care. Supportive Therapy will consist of supportive but non-directional     interaction with the patient exploring the impact of aging and diabetes on the patient's     life. The investigators hypothesize that more patients who receive Behavioral Activation will     have a dilated fundus exam (the primary outcome variable), understand the risks of diabetic     complications and feel less depression then subjects who receive Supportive Therapy.   "
253764|NCT01179568|"     The major goal of this 4-site, double blind, placebo-controlled intervention trial is to     assess the efficacy of medication (Citalopram) alone or with psychotherapy (Complicated Grief     Therapy) to treat the symptoms of complicated grief.   "
253765|NCT01179581|"     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)     and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food).      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple     oral administration will be evaluated, and, if applicable, the maximum tolerated dose     determined.   "
253766|NCT01179594|"     This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety     of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without entecavir, in     patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to     receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or     entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously     weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36.     Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target     sample size is <500 patients.   "
253767|NCT01179607|"     M0002, an orally active, selective non-peptidergic antagonist of the vasopressin V2 receptor     inhibits vasopressin-induced water reabsorption from the kidney. Therefore the aquaretic     effect of M0002 has a potential clinical benefit in the treatment of ascites and     hyponatreamia in cirrhotic patients.   "
253768|NCT01179620|"     This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to     prevent clotting during hemodialysis.   "
253769|NCT01179633|"     The purpose of this study was to demonstrate the effect of short treatment with active OPLON     patches on Acne.   "
253770|NCT01179646|"     The objective of this study was to determine the single-dose bioequivalence of the test     product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared     with the reference product, a pantoprazole 40 mg delayed-release tablet formulation     (Protonix, Wyeth Pharmaceuticals), following a single dose in the fasted state.   "
253771|NCT01179659|"     The objective of this study was to assess the single-dose bioequivalence of KUDCO's and Wyeth     Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed     conditions.   "
253772|NCT01179672|"     The purpose of this trial is to assess the efficacy of duloxetine 60 milligrams (mg) once     daily (QD) compared with placebo, on the change in pain severity from baseline to 12 weeks as     measured by the weekly mean of the daily pain scores recorded in the participant's diary in     participants with diabetic peripheral neuropathic pain.   "
253773|NCT01179685|"     Melanoma antigen (MAGE) gene is known to be expressed in tumor cells, testis and placenta.     The purpose of this prospective study was to investigate the sensitivity, specificity and     accuracy of pleural fluid MAGE gene expression, tumor marker and cytology in the diagnosis of     malignant pleural effusion.   "
253774|NCT01179698|"     Bone tumor near the articular cartilage is hard to remove sufficiently without damaging     adjacent joint. The purpose of this study was to evaluate the feasibility of     navigation-assisted surgery for saving joint in bone tumor resection or curettage. In this     study, the investigators hypothesized that computer-assisted surgery is feasible method to     get both enough margin and joint salvage. Each of them is important intermediate factor for     either oncologic outcome or functional outcome respectively. The investigators designed this     study to find what proportion of patients who underwent computer-assisted resection could get     enough margins using some criteria obtained by overlapping preoperative and postoperative     images. The investigators also evaluated whether computer-assisted surgery can be feasible     for joint saving using some criteria including functional outcome.   "
253775|NCT01179711|"     In most clinics, physicians reduce diopter of hyperopic glasses in older patients with     accommodative esotropia. However, there are risks of decompensation in that practice. The     authors are going to try measure the change of stability of eye alignment after reducing     diopter of hyperopic glasses.   "
253776|NCT01173601|"     The primary purpose of this study is to assess whether at least one dose of LY2216684 (12 mg     or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of     patients with major depressive disorder (MDD) who were identified as partial responders to an     adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI), during an     11-week, double-blind, acute adjunctive treatment phase.   "
253777|NCT01173614|"     The purpose of this study is to determine the average values of human ocular biometry and to     correlate these values with visual function.   "
253778|NCT01173627|"     The purpose of this study was to evaluate the oral bioequivalence of the Mallinckrodt test     fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.)     under fasting conditions.   "
253779|NCT01173640|"     Adverse events due to drug-drug and/or herb-drug interactions are of serious concern and a     major cause of morbidity and mortality. Resveratrol is a polyphenol antioxidant that has been     identified in over 70 species and is suggested to be the constituent in red wine responsible     for cardioprotective effects. The potential health benefits of resveratrol supplements are     highly extolled in the alternative medicine industry and daily doses are up to 5 grams are     being studied. While there are potential health benefits of high doses of resveratrol, for     patients taking other drugs metabolized by CYP3A4, such as transplant medications,     chemotherapies and HMG-CoA reductase inhibitors, there may be a clinically significant     herb-drug interaction.      We, the investigators, have shown in vitro that resveratrol is a mechanism-based inhibitor of     cytochrome P450 3A4 (CYP3A4). Based on our in vitro evidence and literature reports of the     pharmacokinetics of resveratrol, we hypothesize that resveratrol will be a potent in vivo     mechanism-based inhibitor of intestinal CYP3A4 enzymes. To date, there are no clinical     studies that address the potential for a resveratrol-drug interaction. We propose to test     whether single and multiple doses of resveratrol alter the pharmacokinetics of midazolam, a     prototypic CYP3A4 probe drug.   "
253780|NCT01173653|"     The emergency department (ED) serves a vital and growing role in the US health care system,     responsible for both the delivery of emergent medical care and for safety-net care for     populations without traditional access to health services. Uninsured populations rely     significantly on the safety-net services of the ED. Between 2000-2005 the number of uninsured     Americans increased from 39.6 million to 46.1 million, and this growth is expected to     continue. Many health policy analysts consider the ED to be an effective place to provide     preventative care. Prophylactic tetanus immunization, for example, has been a successful     preventive health intervention that has become a standard of care in the ED setting. Brief     smoking cessation interventions have been introduced in the ED but have not had great success     based on lack of follow-up and continuity.      Our study is novel in that it introduces a brief smoking intervention through use of an     established, federally-funded and federally-sponsored cessation counseling resource, the     National Smoking Cessation Quit Line, also available at smokefree.gov. This is a joint     initiative between the Tobacco Control Research Branch of the National Cancer Institute and     the Centers for Disease Control and Prevention. Since ED patients who smoke often lack the     ability to use self-help cessation resources, we hypothesize that by introducing this     population to the counselors on the National Smoking Cessation Quit Line (also called the     1-800-QUIT-NOW line) during the ED visit via phone, that this new brief intervention would     have a realizable and significant effect on smoking cessation among the this population.   "
253781|NCT01173666|"     The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study is a     randomized controlled trial designed to evaluate the effect of renal artery stenting+medical     therapy versus medical therapy alone on left ventricular mass progression and cardiovascular     morbidity and mortality in patients affected by coronary artery disease and renal artery     stenosis.   "
253782|NCT01173679|"     Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) are similar diseases     of the white blood cells and are typically treated the same way. Recent research shows that a     key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN kinase.     Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death of     CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some     effect on CLL cells. The purpose of this study is to see of the study drug dasatinib, in     combination with fludarabine and rituximab, is safe and effective to use for people with     relapsed or refractory CLL/SLL.   "
253783|NCT01173692|"     The goal of this clinical research study is to learn if minocycline can reduce the symptoms     reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of     head and neck, who receive treatment with radiation therapy.   "
253809|NCT01176994|"     Existing methods of diagnosing and treating skin lesions are either surgical, which enables     an histological diagnosis or destructive (electrodesiccation, liquid nitrogen, laser,     caustics) with no possibility of obtaining histology. The ingredients of current formulations     for in-vivo skin fixation (Mohs, Solcoderm) are unstable, inconvenient for application and     painful - therefore their use was abandoned. The investigators will examine the safety of     stable formalin-free formulations for in-vivo fixation of human skin lesions .These     formulations were safe and had a rapid onset of fixation effect in in-vivo animal studies.   "
253784|NCT01173705|"     In this project, we propose to recruit lean and obese subjects with different ethnic     background (African Americans and Caucasians) to study the alterations of lipid and     carbohydrate metabolism and determine whether these disturbances are linked to genetic,     inflammatory, oxidative stress, and/or nutritional factors. Because systemic inflammation and     insulin resistance are frequent features of obesity, we postulate that an unbalanced diet     with high saturated- and low omega 3-fatty acids is linked to obesity-related inflammation     and insulin resistance. We propose to investigate fatty acid metabolism and determine the     links between fatty acid composition and oxidative stress in tissues of lean and obese     subjects. We propose the following aims:      Specific Aim 1: Evaluate nutrient intake in lean and obese subjects using the standard NHANES     Food Questionnaire.      Specific Aim 2: Evaluate the fatty acid composition, including omega-3, in adipose tissue     depots, blood monocytes and skeletal muscle, and examine the relationship between omega-3     content and inflammatory and oxidative stress markers.      Specific Aim 3: Compare the effects of omega-3 and saturated FA supplementation on     inflammatory and oxidative stress markers in vitro in adipose tissue explants, preadipocytes     and monocyte culture.   "
253785|NCT01176682|"     The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis     and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in     usual clinical practice, how patients comply with their treatment and how satisfied they are     with their treatment.   "
253786|NCT01176695|"     The purpose of the study is to compare a fish oil containing lipid emulsion against a     medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and     safety during postoperative parenteral nutrition.   "
253787|NCT01176708|"     The aim of the study is to investigate the significance of intact nerve supply to the liver     for the glucagon-like peptide-1 (GLP-1) induced insulin secretion.      The hypothesis is that the effects of GLP-1 is transmitted through the GLP-1 receptor and     that these effects involve sensory afferent neurons, probably primarily parasympathetic.   "
253788|NCT01176721|"     Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy     and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in     schizophrenia.      Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive     impairment,and aggressive behavior of treated schizophrenia patients.   "
256025|NCT02012608|"     This study is a single-centered, double-blind, two-arm randomized study to determine if oral     glutamine will reduce radiation toxicity for the subjects undergoing Breast Conserving     Therapy.   "
253790|NCT01176747|"     The purpose of this study is to investigate the lung deposition and distribution pattern of     Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a     single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the NEXT     DPI in healthy volunteers, asthmatic and COPD patients. Additionally, the systemic exposures     to formoterol, BDP and its monopropionate metabolite (B17MP) will be investigated.   "
253791|NCT01176760|"     The aim of this study is to investigate the role of transmission via the vagal nerve for the     effect of glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion.      The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous     system and for this reason the investigators will research individuals with and without     intact nervous supply.   "
253792|NCT01176773|"     The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra     Lip Injectable Gel for lip enhancement.   "
253793|NCT01176786|"     This study will look at the rate of infections developed by subjects comparing the use of     disposable draping systems versus reusable draping systems in the operating room.   "
253794|NCT01176799|"     This is a single-centre, phase II randomized study of doxorubicin and cyclophosphamide (AC)     with or without intermittent sunitinib in patients with measurable primary breast cancer who     are receiving pre-operative chemotherapy.      A lead-in phase I study was built into this protocol to determine the dose and duration of     sunitinib that may achieve the desired effects of normalizing tumor vasculature prior to     chemotherapy administration.      A total of 64 patients with measurable primary tumor will be enrolled for the Phase II part     of the study. Eligible patients will be randomized 1:1 to either arm A or arm B. Patients     will be stratified according to metastatic status (metastatic vs non-metastatic) and presence     or absence of clinical T4 disease.      Arm A (Control arm):      Doxorubicin 60mg/m2 day 1 Cyclophosphamide 600mg/m2 day1, every 3 weeks x 4 cycles      Arm B (Experimental arm):      Days -13 (or -7) to day 0 (total 7 or 14 days) - oral sunitinib daily (duration and dose as     determined from the lead-in phase I study) Cycle 1: day 1 - Cycle 1 AC (60/600mg/m2); days     15-21 - oral sunitinib daily Cycle 2: day 1 - Cycle 2 AC (60/600mg/m2); days 15-21 - oral     sunitinib daily Cycle 3: day 1 - Cycle 3 AC (60/600mg/m2); days 15-21 - oral sunitinib daily     Cycle 4: day 1 - Cycle 4 AC (60/600mg/m2)      DCE-MRI scan will be performed serially to determine tumor response and change in tumor     vascular parameters for each enrolled subject:      Patient will be evaluated weekly for toxicity assessments and full blood count during cycle     1, and on days 1 and 15 of each subsequent cycle. In addition, patients in Arm B will be     evaluated weekly during the first two weeks of sunitinib administration prior to cycle 1 AC.   "
253795|NCT01176812|"     The face is arguably the most critical aesthetic unit of the body. As humans begin to age,     numerous changes occur to the face. Changes include the formation of wrinkles, soft-tissue     atrophy, gravitational descent resulting in sagging skin, loss of skin and muscle tone, and     changes in bony architecture. These changes are potentiated in our population secondary to     sun exposure and smoking. To combat the effects of aging on the face, a multitude of products     and procedures exist to attempt to reverse the effects of sun damage and aging to achieve a     youthful and rejuvenated appearance. There has been a shift from invasive procedures such as     a facelift to noninvasive means using filling agents to restore lost contour deformities.      The investigators hypothesis is that the use of dermal filling agents effectively delays the     need for invasive procedures such as facelifts, and that patient satisfaction has increased     with the evolution of recent dermal filling agents.   "
253810|NCT01177007|"     This study is an open label prospective trial of TheraSphere treatment for patients who have     liver metastases who have failed or are intolerant to other systemic or liver directed     therapies. Patients will be treated with TheraSphere at doses of 120 ± 10% Gy, and then     followed for time to progression (TTP), safety, and overall survival.   "
253796|NCT01176825|"     The aim of the study is to develop and pilot test a cognitive-behavioral (CBT) intervention     for young adults, ages 18-24 with bipolar disorder. The 14-week intervention focuses on     improving management of bipolar disorder, reducing involvement in high-risk behaviors, and     enhancing psychosocial functioning. The intervention also focuses on issues specific to     transition-age youth. The study includes two phases: In phase 1, the intervention will be     developed, refined, and openly piloted with several participants. In phase 2,the     investigators will conduct a randomized clinical trial, in which 40 participants will be     randomized either to receive the intervention right away, or to a 14-week waitlist condition.     Participants will be evaluated at baseline, week 5, week 10, and week 14 of the study period,     as well as at 3- and 6-month follow up, using measures of mood symptoms, high-risk behaviors,     drug and alcohol use, and psychosocial functioning.   "
253797|NCT01176838|"     The purpose of this study is to provide the physicians with quality long term follow up data     on subjects from the Breast Cancer Clinic and the Plastic Surgery Clinic who have been newly     diagnosed with breast cancer and will receive treatment for the cancer at this facility. Over     the last two decades many studies have been done concerning the quality of life after a     mastectomy and/or reconstruction process. The majority of these studies only run for one year     post reconstruction, some however, do include a two year follow up. The investigators are     proposing a 5 year long term follow up study on subjects who will be diagnosed and treated     here at the Breast Cancer Clinic and the Plastic Surgery Clinic. The investigators first     questionnaire will be given prior to any treatment for breast cancer, giving us a baseline     for the subject's current quality of life. At each successive year, the subject will be given     another questionnaire with regards to their progression through the reconstructive process.     At the end of 5 years, the subject will complete a final questionnaire. These questionnaires     will deal with many areas of daily life functions; activities of daily living, anxiety,     depression, social interactions, personal and sexual relationships.   "
253798|NCT01176851|"     The purpose of this study is to investigate the pharmacokinetics, the absolute     bioavailability and the lung bioavailability of inhaled Glyco pMDI.   "
253799|NCT01176864|"     Double-balloon enteroscopy (DBE) is now an established method for diagnostic and therapeutic     small-bowel endoscopy. Single-balloon enteroscopy (SBE) has been introduced to simplify the     technique. A prospective randomized study was carried out to compare the two methods in     obscure small bowel bleeding   "
253800|NCT01176877|"     The purpose of this study is:        -  to identify how knowledge about keloid scars and self-treatments differs between          patients who use the Internet as a source of information and patients who do not        -  to determine if patients who are at a high risk of developing additional keloid scars          are more or less likely to change their behavior based on an educational information          talk about keloid scar prevention   "
253801|NCT01176890|"     The aim of this study is to investigate the role of transmission via the vagal nerve for the     effect of Glucagon-like peptide-1 (GLP-1) in respect to gastric emptying, appetite and food     intake.      The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous     system and for this reason the researchers will investigate individuals with and without     intact nervous supply.   "
253802|NCT01176903|"     The purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as     pMDI after single and repeated administration.   "
253803|NCT01176916|"     Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women     with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years     of tamoxifen & are switched to Aromasin® for completion of a total of 5 consecutive years of     adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial     waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since     then, there is currently lack of systematic collection and analysis for the efficacy and     safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin®     Non-Interventional Study is being proposed to collect data systematically and to assess the     efficacy and safety of Aromasin® adjuvant setting in Chinese population.   "
253804|NCT01176929|"     The prevention of recurrent suicidal about people who have made a suicide attempt is a major     strand in the prevention of suicide. It is estimated that 10-15 % of people who made a     suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the     subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 % at     one year. Most people who made a suicide attempt receive ambulatory monitoring. On this     population, there is a low adherence to care.      The main objective of the study is to test the effectiveness of a prevention program of     recurrent suicidal acts for people who made a suicide attempt.      The secondary objectives of this study are the assessment of adherence to care; the     identification of sub - populations benefiting most from this program; the evaluation of the     possible generalization level of the program (eligibles persons rate) and its feasibility     level.   "
253805|NCT01176942|"     The purpose of this study is to determine whether probiotic treatment of overweight     volunteers consuming high fat diet is able to reduce plasma lipopolysaccharide concentration.   "
253806|NCT01176955|"     This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with     mild to moderate acne. Study subjects will be randomized to an internet survey group, in     which an email link for a survey ascertaining the status of the subject's acne is sent     weekly, or to a control group. All study subjects will use benzoyl peroxide 5% gel, and     adherence and clinical improvement will be monitored over 12 weeks. The investigators     hypothesis is that subjects in the internet survey group will have improved adherence to the     study medication and clinical outcomes, because the weekly survey will remind subjects to use     their medication.   "
253807|NCT01176968|"     Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction,     in patients without heart failure, reduces cardiovascular mortality / morbidity.   "
253808|NCT01176981|"     The primary purpose of this study is to determine the safety and feasibility of delivering     HDMTX in an outpatient setting.   "
253811|NCT01177020|"     Identification of the presence of proangiogenic immune cells in normal human placentas may     enable predication of some pregnancy disorders.   "
253812|NCT01177033|"     CLINICAL TRIAL PROTOCOL SUMMARY / SYNOPSIS      Phase: IV      TITLE OF STUDY      Angioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised     controlled trial for patients with complex lesions of the superficial femoral artery      CONDITION      Peripheral arterial occlusive disease (PAOD)      OBJECTIVE(S)      The objective of this study is to evaluate the safety and efficacy of two therapeutic     strategies (operative versus endovascular) in the treatment of patients with complex     atherosclerotic lesions of the superficial femoral artery.      INTERVENTIONS      Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention     type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein     (1° choice) or a prosthetic graft (if vein is not available).      Duration of intervention per patient: Dependent on the method of treatment      Follow-up per patient: 24 months      OUTCOMES      Primary efficacy endpoint:      Two primary efficacy endpoints will be considered simultaneously in this trial:      (A) Event-free survival (time-to-event endpoint): Proportion (over the course of time) of     surviving patients who show a continuing clinical improvement of >= 1 class (Rutherford     classification) without the need for repeated target lesion revascularization (TLR).      (B) Proportion of surviving patients with clinical improvement of >= 1 class (Rutherford     classification) at 24 months after primary intervention (regardless any performed     re-intervention).   "
253813|NCT01177046|"     The findings of this research will be used to develop a scale for measuring the quality of     epidural pain relief achieved during labour and vaginal delivery.   "
253814|NCT01177059|"     The purpose of this Observational Study is long term follow-up of the Human Immunodeficiency     Virus -1 (HIV-1) infected patients who have received a gene therapy product (anti-HIV-1     Ribozyme [OZ1]) as part of an earlier phase 2 trial. Patients are seen twice yearly until 5     years from initial infusion of study drug has elapsed and then yearly until withdrawal or     study completion. The study will monitor for and record any ill effects from the gene therapy     product to provide long term safety information.   "
253815|NCT01177072|"     1. That the psychotherapeutic intervention - Components-Base Interventions (CBI) - is          effective in reducing the severity of mental health symptoms experienced by torture          survivors in Southern Iraq.        2. That the psychotherapeutic intervention - Cognitive Processing Therapy (CPT) - is          effective in reducing the severity of mental health symptoms experienced by torture          survivors in Southern Iraq.   "
253816|NCT01177085|"     This is a one-year clinical trial to assess weight-loss, weight-maintenance, and biochemical     parameters following a weight-control diet using either standard food guide pyramid alone, or     standard food guide pyramid with substitution of mushrooms for meat.   "
253817|NCT01177098|"     This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A     ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once     daily for 12 weeks in patients with glaucoma or ocular hypertension.   "
253818|NCT01177111|"     Each year four million babies die during the neonatal period, with the majority occurring in     developing countries. Overall, infections account for one-third of all neonatal deaths, with     proportions approaching 50% in settings where neonatal mortality rates are high. Infections     are predominately due to sepsis, respiratory infections, tetanus, and diarrhea. The     investigators long term goal is to identify simple, affordable, and effective interventions     that can be delivered at the community level in low-resource settings to reduce neonatal     mortality risk due to these infections. The investigators team has conducted research in this     area for the past 10 years, with specific focus on newborn vitamin A dosing and topical     chlorhexidine antisepsis interventions. Previous community-based research by the     investigators group of investigators and others demonstrated that newborn vitamin A dosing     can reduce early infant mortality by approximately 20%, and that topical applications of     chlorhexidine to the umbilical cord can prevent omphalitis and reduce neonatal mortality risk     by 24%. Evidence is growing that neonatal skin plays an important role in protecting the     newborn infant from invasive pathogens. Barrier function of the neonatal skin, however, is     incomplete in newborn infants, especially those that are pre-term or of low birth weight.     Full-body massage of newborns with mustard oil, practiced almost universally (~95%) in     communities of south Asia, may further compromise skin barrier function through decreased     structural integrity leading to increased trans-epidermal water loss and increased risk of     percutaneous penetration by invasive pathogens. Loss of structural integrity is not seen     after massage of neonatal skin with alternative topical emollients, including sunflower seed     oil. Furthermore, sunflower seed oil has been shown to accelerate recovery of the skin     barrier function, improve skin condition, and reduce the risk of both nosocomial infections     and neonatal mortality among hospitalized newborns in low-resource settings. The specific     hypothesis of this study is that substituting mustard oil with sunflower seed oil for topical     applications during full body massage of newborns in the community will reduce neonatal     mortality and morbidity by improving overall skin barrier function and reducing exposure to     invasive pathogens.   "
253819|NCT01177124|"     The purpose of this study among breast cancer survivors is three-fold: (i) to evaluate the     efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of     life and measures of immune function and a stress hormone (cortisol); (ii) to test whether     positive effects achieved from the MBSR(BC) program are mediated through changes in     mindfulness and fear of recurrence of breast cancer; and (iii) to evaluate whether positive     effects achieved from the MBSR(BC) program are modified by specific patient characteristics     measured at baseline.   "
253820|NCT01177137|"     The primary purpose of the Tinnitus Retraining Therapy Trial (TRTT) is to assess the efficacy     of tinnitus retraining therapy (TRT) as a treatment for severe debilitating tinnitus. TRT is     a non-medical intervention that uses directive counseling (DC) and sound therapy (ST)to     habituate the patient's associated negative emotional reactions to tinnitus, its perception,     and ultimately, its impact on the patient's life.   "
253821|NCT01177150|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and     or the pharmacodynamics (PD) of single oral doses of JNJ-28431754 in healthy male volunteers.     The study will evaluate the PK and PD effects of study drug in volunteers who fasted compared     to those who did not fast before study drug administration.   "
253822|NCT01177163|"     The purpose of this study is to evaluate the safety, tolerability, pharmacodynamic effects     and pharmacokinetic characteristics of JNJ-28431754 after multiple dosing in patients with     Type 2 Diabetes Mellitus who are on a stable dose of insulin.   "
253840|NCT01177397|"     The main purpose of this first human study with CC-223 is to assess the safety and action of     a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors     unresponsive to standard therapies and to determine the appropriate dose and tumor type for     later-stage clinical trials.   "
253841|NCT01177410|"     The purpose of this study is to determine the daily dose of mesalamine granules that will     provide adequate relief from symptoms of IBS with diarrhea.   "
253894|NCT01178112|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of trientine and carboplatin that can be given to patients with advanced cancer.     The safety of this drug combination will also be studied.   "
253823|NCT01177176|"     Cigarette smoking is the leading preventable cause of death in the U.S. Nearly 4 million U.S.     smokers are hospitalized each year, many of them at high risk for tobacco-related disease or     death. A hospital admission provides an opportunity for a smoker to quit. Smoking cessation     counseling provided in the hospital is effective, but only if it continues for >1 month after     discharge. Smoking cessation medications add benefit to counseling but are not often used.     The challenge is to translate this efficacy research into routine clinical practice. The     major barrier is to make the transition from inpatient to outpatient care. An evidence-based,     cost-effective intervention model that can be adopted by U.S. hospitals is needed to realize     the potential impact of hospital smoking interventions.      The Specific Aim of this project is to conduct a randomized controlled comparative     effectiveness trial of two strategies to promote smoking cessation in hospitalized patients:     (1) a hospital-only intervention that meets the current standard of the National Hospital     Quality Measures(Standard Care), and (2) an Extended Care Management model with 2     components that aims to encourage and facilitate the sustained use of smoking cessation     treatment (counseling and medication use) after discharge in order to achieve long-term     abstinence. It adds to Standard Care 3 months of telephone-based contact after discharge and     feature 2 innovations: (1) to increase medication use, smokers willing to make a quit attempt     receive a free, refillable 30-day sample of their choice of FDA-approved smoking cessation     medication at hospital discharge; (2) to increase counseling cost-effectiveness, interactive     voice recognition (IVR) technology is used to make automated telephone calls to identify the     smokers interested in or most likely to benefit from continued counseling after discharge.     The trial will enroll 330 adult smokers admitted to Massachusetts General Hospital, a 900-bed     teaching hospital. Outcomes will be measured 1,3 and 6 months after hospital discharge. Study     hypotheses are that the enhanced care arm, compared to usual care, is feasible and will     increase (1) the use of smoking cessation treatment after discharge, (2) the duration of     post-discharge tobacco abstinence, and (3) validated tobacco abstinence 6 months after     hospital discharge (primary outcome). The principal secondary outcome measure is     self-reported 7-day point prevalence tobacco abstinence after hospital discharge. Other     secondary endpoints include self-reported point prevalence abstinence at 1 and 3 months,     prolonged abstinence (self-reported tobacco abstinence at 1, 3, and 6 months). The     cost-effectiveness (cost per quit) of the interventions will be also be compared.   "
253824|NCT01177189|"     The purpose of this study is to understand why and how oxidative stress negatively impacts     mobility in the elderly, and to determine whether antioxidant supplements can increase     vascular health and mobility.   "
253825|NCT01177202|"     The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1     Vaccine In Healthy Adults   "
253826|NCT01177215|"     The purpose of this study is to reduce the length of drainage using a treatment protocol to     control the manipulation of the applied vacuum to the pleural cavity.   "
253827|NCT01177228|"     The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics     (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative     colitis (UC).   "
253828|NCT01177241|"     Using a retrospective analysis of a large commercial claims database and a Medicare database,     the investigators evaluated DDEs that have the potential to cause DDIs among chronic low back     pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450     enzyme system, concomitant with other CYP450-metabolized drug(s)   "
253830|NCT01177267|"     Using a retrospective database analysis, OA patients taking at least one CYP450-metabolized     opioid (codeine, fentanyl, hydrocodone, methadone, oxycodone, or tramadol) and at least one     other prescription drug metabolized via the CYP450 system were evaluated for an incident     drug-drug exposure (DDE), which places them at risk for experiencing a pharmacokinetic     drug-drug interaction (DDI).   "
253831|NCT01177280|"     This study explored the prevalence of DDEs in a chronic pain population with cLBP and     associated healthcare utilization and costs using a healthcare claims database.   "
253832|NCT01177293|"     This study is being performed to determine the bioavailability, or extent of absorption into     the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to     the bioavailability of a 10 mg amlodipine besylate capsule.   "
253833|NCT01177306|"     Minimum 24 subjects aged 8-12 with a diagnosis of ADHD will be prescribed extended release     guanfacine (Intuniv) to assess impact, if any, on working memory. Pre and post testing using     a standardized battery of tests for effect on symptoms of ADHD and working memory will be     administered and assessed.   "
253834|NCT01177319|"     This is an investigator initiated pilot study to examine the effects of GSH in PD. The goal     of this study is to acquire some basic data regarding side effects and efficacy of this     compound to determine if this is a possible treatment option that could be recommended to     interested PD patients.   "
253835|NCT01177332|"     There is increasing evidence that hepatic lipid content (IntraHepatic Lipid, IHL) markedly     increases the risk of metabolic complications, including insulin resistance and     cardiovascular events. The investigators hypothesize that the liver is passively taking up     free fatty acids (FFA) when the availability is high, thereby leading to an increased     storage. To test this hypothesis, the investigators want to manipulate FFA levels, by means     of a fasted exercise and recovery protocol, and monitor IHL content and hepatic Adenosine     triphosphate (ATP) and inorganic phosphate (Pi) concentrations.   "
253836|NCT01177345|"     Cervical cancer screening is a worldwide problem especially in the developing world of which     Tanzania belongs. It is diagnosed late in the third world because there are no diagnostic     facilities and resource people. It occurs in the age groups between 40 and above and     therefore affects the productive age of the community. It is well known that women generally     are the backbone of every community and specifically in the developing countries.      The objective of this research is to analyze and quantify the burden of cervical cancer     disease in the community. It will research the interpersonal and socioeconomic issues     associated with cervical cancer disease in the family.   "
253837|NCT01177358|"     The investigators hypothesize that Botox A will reduce scarring and improve healing of     surgical neck wounds.   "
253838|NCT01177371|"     RATIONALE: Giving high doses of chemotherapy drugs, such as busulfan and cyclophosphamide,     before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop     the patient's immune system from rejecting the donor's stem cells. When the healthy stem     cells from a donor are infused into the patient they may help the patient's bone marrow make     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted     cells from a donor can make an immune response against the body's normal cells. Giving     cyclosporine, methylprednisolone, and methotrexate after transplant may stop this from     happening.      PURPOSE: This clinical trial studies high-dose busulfan and high-dose cyclophosphamide     followed by donor bone marrow transplant in treating patients with leukemia, myelodysplastic     syndrome, multiple myeloma, or recurrent Hodgkin or Non-Hodgkin lymphoma.   "
253839|NCT01177384|"     This study will evaluate whether the addition of sitagliptin reduces hemoglobin A1C (A1C)     more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a     steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg     once daily (q.d.) reduces A1C more than the addition of placebo in participants with T2DM     with inadequate glycemic control on acarbose monotherapy.   "
253842|NCT01177423|"     Management of dental pain emergencies is a challenge for the clinician, particularly when     pain is due to endodontic infection.      Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior     alveolar nerve block for mandibular molars anesthesia.      The aim of the study is the evaluation of Quicksleeper efficiency used in first intention     versus inferior alveolar nerve block used in most current dental treatment.   "
253843|NCT01177436|"     Nowadays, prostate cancer screening is largely widespread although it is not recommended yet.     This screening includes primarily digital rectal examination and PSA.      Recently, a new specific genetic marker of prostate cancer has been discovered. It is PCA-3     gene.      The main objective is to evaluate prospectively this new marker in patients treated for     prostatic pathology (benign or malign) in the department.   "
253844|NCT01177449|"     The purpose of this study is to investigate the effect of prolotherapy on balance and lumbar     flexibility in the patients with a sacralized L5 vertebra. Evaluations for ability on balance     include sensory organization test (SOT,) rhythmic weight shifting (RWS) and limits of     stability (LOS.)   "
253866|NCT01177735|"     This is a phase II study, open-label, single institution trial of pomalidomide in     GEP-defined, high-risk relapsing/refractory multiple myeloma. Prior therapy must have     included lenalidomide. Patient accrual is 30 over a 2 year period.      Primary objective:        -  To determine progression-free survival (PFS) after initiation of pomalidomide therapy      Secondary objective:        -  To determine the response rate (CR, n-CR, VGPR) and duration of response after          pomalidomide therapy.        -  To determine gene expression profiling (GEP) changes exerted within 48 hours of          initiation of daily pomalidomide dosing.        -  To determine gene expression profiling (GEP) changes exerted within 48 hours of          initiation 3 concurrent days of exposure to lenalidomide.        -  To determine MRI- and PET-CT-defined CR in studies obtained at baseline and every 6          month examinations.   "
253845|NCT01177462|"     Manipulation of object is a multisensory experience that includes tactile motion between the     object and the fingerpad, visual motion elicited by the motion the object and the movement of     the hand, and the active motor commend to control upper limb and hand conformation. It     remains to be determined how such a complex interaction between touch and vision could be     achieved effortlessly. In the present study, we will investigate how the motion information     is transformed between touch and vision using the most novel approaches in human     psychophysics, neuropsychology and monkey neurophysiology. Specifically, we will present     tactile motion on primate fingerpads using a recently developed ball stimulator with a design     in which we vary the direction of motion with respect to the skin surface and also vary the     hand conformation and position. This setup allows us to systematically sample the possible     scenarios involving coordinate transformation between the somatosensory and visual systems in     conditions that could occur in hand exploration and object manipulation in daily life. We     will present these tactile stimuli on normal human subject as well as stroke patients such as     patients with spatial hemineglect. Finally, we will record from macaque monkeys in cortical     areas that are thought to underlie the transformation of coordinates, such as the primary     somatosensory cortex and posterior parietal cortex. The results of the present study will     contribute to the understanding of multisensory integration and the rehabilitation for     patients with impaired use of spatial information.   "
253846|NCT01177475|"     It seems important to correlate real consumption in bioactives molecules of natural milk     versus pasteurized with gut maturation in very preterm infants during small enteral feeding     protocol. This objective will be reached through a clinical trial.   "
253847|NCT01177488|"     The purpose of this study is to determine whether therapy for Operation Iraqi     Freedom/Operation Enduring Freedom (OIF/OEF) veterans with Post-traumatic Stress Disorder     (PTSD) symptoms can be delivered effectively using videoconferencing technology     (telepsychology), which allows a therapist and patient who are not in the same room as one     another to communicate.   "
253848|NCT01177501|"     The early relapse of ovarian cancer occurring within 6 months of chemotherapy including     platinum regimen are called relapses 'platinum resistant' consecutively patients die quickly     of their disease. For relapses occurring between 6 and 12 months, no recommendation occur and     few studies are conducted. Therefore it seems interesting to develop a research on intensive     chemotherapy using a combination of carboplatin (a drug widely used in most ovarian cancer)     with Topotecan , use in a high dose protocol. Topotecan has demonstrated its efficacy in     relapse ovarian cancer and its possible use in high doses, a recent study (ITOV01) have     demonstrated the feasibility of dose escalation of topotecan monotherapy (MTD set at 9 mg /     m² / dx 5 days). This project is a feasibility research of the combination of topotecan and     carboplatin in a high dose escalation protocol for early ovarian cancer relapse occurring 6     to 12 months after conventional chemotherapy-based platinum salts.   "
253849|NCT01177514|"     The primary aims of this study are to determine if treatment with Gabapentin taken     systemically (oral tablets) in patients who have photorefractive keratectomy (PRK) surgical     treatments reduces post surgical neuropathic pain and discomfort. The investigators main     Hypothesis is that gabapentin given prior to and after refractive surgery prevents central     sensitization and local allodynia.   "
253850|NCT01177527|"     The purpose of this study is to obtain bone marrow and peripheral blood samples, along with     clinical data from patients with Multiple Myeloma (MM), Waldenstrom's Macroglobulinemia (WM),     Smoldering MM, and other lymphoplasmacytic lymphomas (LPL) including but not limited to MGUS     and IgG or IgA LPL. These samples will become part of a tissue bank and will be used in     ongoing studies to find out more about the causes and biology of MM, WM and LPL; to identify     what factors result in normal cells becoming cancer; to determine how to improve treatment     options; to study how the immune system identifies abnormal cells; and to evaluate the immune     function in these diseases. The investigators will also study the tumor cells at the level of     the participant's genes to develop treatment strategies as well as to better understand how     biologic differences affect patient outcomes.   "
253851|NCT01177540|"     The purpose of this study is to provide data on the activity of a standard daunorubicin,     cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed     by standard measures of complete remission (CR), leukemia free survival (LFS) and overall     survival (OS), as well as, on minimal residual disease (MRD). It will also provide necessary     data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients that is     currently unavailable.   "
253852|NCT01177553|"     Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton     pregnancies, in 9.1% of all twins and 9.9% of monochorionic twins. IUGR in monochorionic     twins typically affects only one of the fetuses (selective IUGR or SIUGR). Spontaneous demise     of the SIUGR twin can occur, and may result in concomitant demise (up to 40% risk) or severe     neurologic handicap (up to 30% risk) of the other twin. These complications result from     exsanguination of the appropriately grown (AGA) twin into the demised SIUGR twin through     placental vascular communications.      Because the adverse effects to the AGA twin of the spontaneous demise of the SIUGR twin are     mediated through placental vascular anastomoses, we have proposed obliterating such     anastomoses via endoscopic fetal surgery. We have developed a technique that allows us to     identify the vascular anastomoses present in monochorionic placentas. Briefly, deep AV     communications are identified on the surface of the placenta by noting that the terminal end     of the artery of one of the fetuses does not have a corresponding returning vein to the same     fetus. We have speculated that the separation of the circulations may be of benefit in     monochorionic twins affected by SIUGR by preventing the adverse effects that may result from     the spontaneous demise of the IUGR twin. Our goal is to evaluate with a randomized clinical     trial the outcome of SIUGR managed either expectantly or with SLPCV.      Study procedures will begin with confirmation of the diagnosis and screening criteria at the     Qualified Clinical Center. The patient will sign the appropriate consents and then be     randomized to her treatment group. Enrollment data will be submitted to the research     coordinator in Coordinating Center in Tampa. Expectant management patients will be treated by     the referring physicians. Laser patients will be treated at Coordinating Center in Tampa     General Hospital or qualified laser center. They may return to the referring center for     follow-up. After delivery, outcome data will be sent to the research coordinator in     Coordinating Center in Tampa.   "
253853|NCT01177566|"     The purpose of this study is to assess a bilateral comparison between pimecrolimus cream 1%     (Elidel®) and a medical device cream (EletoneTM) in the treatment and management of atopic     dermatitis. Study subjects will apply pimecrolimus twice daily for four weeks on a target     area located on one side of the body, and apply the medical device cream three times daily     for four weeks on the opposite side of the body at a target lesion symmetric to the other.   "
253895|NCT01178125|"     This is an open-label, single treatment study. All subjects will receive 12 months of oral     contraceptive therapy with DR-102. Study participants will receive physical and gynecological     exams, including Pap smear. During the study, all participants will be required to complete a     daily diary.   "
253854|NCT01177579|"     Copper is an essential nutrient for humans and is cofactor in enzymes that participate in     critical body functions. Insufficient copper can lead to hematological and neurological     abnormalities that may be irreversible if left untreated. Copper deficiency is believed to be     rare in the U.S. population because typical dietary intake is usually sufficient to meet     requirements. More recent evidence suggests that specific populations may be susceptible to     copper deficiency in cases where copper absorption in the gut is impaired following gastric     surgery or in individuals with high intakes of zinc. Preliminary studies by us and others     have identified significant levels of moderate and severe symptomatic copper deficiency in     patients who have undergone weight loss (bariatric) gastric bypass surgery. Copper deficiency     in humans is difficult to recognize and treat because current diagnostic tools rely on     measures of plasma concentrations of copper and ceruloplasmin, which are neither sensitive     nor specific for copper deficiency, and early warning blood markers (biomarkers) have not     been identified. Recent developments indicate that copper chaperone molecules and     cuproenzymes such as cytochrome C oxidase and superoxide dismutase may be more sensitive to     changes in copper status, but there has been very little work done in humans. The studies     outlined here are aimed at assessing copper status using these biomarkers in gastric bypass     surgery patients who are at risk for symptomatic copper deficiency. In addition, patients     identified to be deficient will be supplemented with copper and this treatment will be     evaluated using biomarker concentrations. The findings of these studies should provide     insight into the effectiveness of novel biomarkers to identify those at risk and to guide     appropriate treatment to prevent serious and permanent morbidity due to copper deficiency.   "
253855|NCT01177592|"     This is a prospective, single-center, randomized trial including 1500 subjects requiring PCI.     Subjects with ischemic heart disease due to stenotic lesions in either native coronary     arteries or coronary artery bypass undergoing PCI with stent placement and no     contraindication to prolonged dual antiplatelet therapy (≥1 year) are eligible to be in the     study. Subjects will be randomized to either guided antiplatelet therapy arm (n=750) or     standard therapy arm (n=750) and undergo laboratory testing, antiplatelet adjustment, and     clinical follow-up for 1 year.      Patients (non-emergent) presenting for PCI will receive standard pre-procedural PCI care as     outlined by the current ACC/AHA guidelines. Subjects will be consented peri- PCI (prior to or     within 24 hours of PCI) and then randomized (1:1 ratio) to guide or standard non-guided     (control) antiplatelet therapy. Physicians will be blinded to genotyping and platelet     function results for subjects randomized to the standard therapy group for the duration of     the study or if endpoint is met. Subjects on chronic clopidogrel or prasugrel therapy (≥ 2     weeks) will be guided by VerifyNow P2Y12 assay, whereas clopidogrel naïve subjects will be     guided by Verigene CYP2C19 genotyping assay. Patients on clopidogrel maintenance and/or in     the control group will also be genotyped; conversely, clopidogrel naïve subjects will have     VerifyNow testing prior to discharge for additional study analysis. Patients in the guided     therapy group that have a measurement of ≥ 230 PRU will be reloaded with 60mg prasugrel and     receive standard maintenance dosing. Similarly, clopidogrel naïve subjects that are     considered CYP2C19*2 carriers will also be reloaded with 60mg prasugrel and receive standard     maintenance dosing (see flow schematic). Patients randomized to the control arm will remain     on 75mg clopidogrel arm throughout the study. All patients will remain on 325mg ASA for one     month and 81-162 mg daily ASA thereafter.      Clinical follow-up (office visit) and post-PCI VerifyNow maintenance testing will occur at 2     weeks, 3 months, and 6 months for patients in the guided therapy group. VerifyNow testing,     adverse event occurrence and drug compliance will be performed as part of follow-up. Patients     having a measurement of ≥ 230 PRU at 2 weeks or the 3 month visit will be reloaded with 60 mg     prasugrel and receive standard maintenance dosing thereafter until the 6-month visit.     Patients in guided and control study arms will return at 6 months for clinical follow-up and     VerifyNow testing. After completing 6 months of the study treatment period, further     antiplatelet therapy will be at the physician's discretion. At 1 year, study subjects will be     contacted via phone for clinical assessment and antiplatelet compliance. Physicians     adjudicating events will be blinded to the therapy assignment.   "
253856|NCT01177605|"     This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness,     stool patterns and growth of two cow's milk-based beverages for children.   "
253857|NCT01177618|"     Chronic obstructive pulmonary disease (COPD) is often caused by cigarette smoking, but     genetic predisposition also influences COPD susceptibility. The purpose of this study is to     identify genetic factors that predispose some individuals to develop COPD.   "
253858|NCT01177631|"     This is a pilot study to evaluate the difference between the protein expression between     hepatocellular carcinoma and tumor with vessel invasion in Asian patients with hepatocellular     carcinoma.   "
253859|NCT01177644|"     This study will evaluate the safety and preliminary effectiveness of PDS 1.0 in patients with     neovascular AMD.   "
253860|NCT01177657|"     The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination     in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area,     Brazil.   "
253861|NCT01177670|"     The Adiana Post-Approval Clinical Study (APACS) has been designed to compile information on     the efficacy and safety of the Adiana Permanent Contraception System in the post market     setting. Specifically, data will be collected that is relevant to the evaluation of the     safety and efficacy of the Adiana System for women who desire permanent birth control by     occlusion of the fallopian tubes. This study is an observational study that is not intended     to test specific hypotheses.   "
253862|NCT01177683|"     This is an open label phase I/II trial to determine the safety and the biologic activity of     the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.   "
253877|NCT01177891|"     The Premature ovarian failure (POF) is a rare syndrome observed in women under 40 who induced     estrogen deficiency and often leads to infertility final. The etiologies of POF remain     unknown in more than 85% of cases. There are 5-10 % of familial cases.The main objective of     this study is to recruit, phenotype and genotype 20 families with at least two subjects with     nonsyndromic POF in order to identify new loci using a single technical standard nucleotide     polymorphisms (SNPs). This study will also include related population and population control.   "
253863|NCT01177696|"     Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of     sanitary problems in adults with chronic diseases, they usually have a lack of experience in     development of psychotherapeutic interventions. However, these interventions are the ones     that achieve better results to reduce symptomatology and improve emotional state of     caregivers.      The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving     the mental health and quality of life of caregivers. This intervention is based on     theoretical approaches to care adjusted to cognitive theory, in order to be applied in     primary health care centres.      To assess a cognitive-behavioural intervention to modify dysfunctional thoughts to properly     face the care.   "
253864|NCT01177709|"     Study hypothesis is that patients on antipsychotics medication treated with metformin will     show loss in weight and improved measures of glucose metabolism.   "
253865|NCT01177722|"     The purpose of this study is to generate immunogenicity and safety data of an investigational     hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when     given along with Prevenar™ and Rotarix™ vaccines.      Primary Objectives:        -  To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T          vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with          Prevenar™ and Rotarix™, in terms of immunoresponses.        -  To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the          licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.      Secondary Objectives:        -  To describe in each group the immunogenicity parameters for all antigens for each          vaccine        -  To assess the safety profile in terms of solicited and unsolicited adverse events and          serious adverse events in each group for each vaccine.   "
253896|NCT01178138|"     This protocol will test the safety, effectiveness and the metabolism and action of prazosin     as a potential therapy for methamphetamine abuse. This will be accomplished by performing a     series of human laboratory studies. In each of these studies, the safety and effectiveness of     the test medication (prazosin) in the treatment of methamphetamine effects will be     determined. The study hypothesis is that prazosin will block the methamphetamine receptor     function, reducing the reinforcing effects of central nervous system effects in humans.   "
253867|NCT01177748|"     Cardiac arrhythmia are frequently observed after stroke. They may on one hand be causative     for the stroke mainly in case of atrial fibrillation but on the other hand present severe     complications of the stroke. In addition, cardiac comorbidity as well as acute myocardial     infarction are frequently found in acute stroke patients. Diagnostics to identify cardiac     arrhythmia in the acute phase of stroke care thus have an important role not only for     adjusting the correct secondary prevention but also to prevent cardiac complications     potentially reducing morbidity and mortality.      The aim of the SAMBA-Study is to systematically assess the prevalence of higher grade     arrhythmias after stroke using a standardized reading of 72h telemetric monitoring in the     first days after stroke onset. In addition, it evaluates different strategies to identify     paroxysmal atrial fibrillation.   "
253868|NCT01177761|"     The study determines the long-term effect of exercise on osteoporotic fracture risk. Since     actually no controlled supervised exercise study exceeds the time frame of 4 years, knowledge     concerning the long-term effect of exercise on fractures and fracture-risk factors is scarce.     Within the Erlanger Fitness and Osteoporosis Study (EFOPS, an ongoing controlled exercise     study with currently 16 years of supervised exercise with 45-50 osteopenic,     early-postmenopausal women in exercise and sedentary control group each, the investigators     therefore focus on overall-fractures, Bone Mineral Density and falls.   "
253869|NCT01177774|"     The purpose of this research is to study why most children who have tics never develop     Tourette syndrome but some do. In other words, we aim to find features that may predict whose     tics will go away and whose tics will continue or worsen, in children ages 5 through 10 years     whose first tic occurred within the past 6 months.   "
253870|NCT01177787|"     The aim of this study is to evaluate the clinical efficacy of reduction of local fat on     ipsilateral thigh through cryolipolysis (zeltiq) and controlateral thigh using by amplitude     modulated frequency (conventional) method.   "
253871|NCT01177800|"     The purpose of this study is to determine the superiority and efficacy of infliximab     induction therapy in chinese participants with moderate to severe plaque-type psoriasis     (scaly skin rash) compared with placebo (an inactive substance that is compared with a drug     to test whether the drug has a real effect in a clinical trial).   "
253872|NCT01177813|"     The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773     compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM     with insufficient glycaemic control. For the open-label part of the study the objective is to     estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM     with very poor glycaemic control.   "
253873|NCT01177826|"     The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing     rotavirus severe gastroenteritis among hospitalized infants, in Belgium.   "
253874|NCT01177839|"     This prospective study aims to estimate the incidence of intussusception among children < 2     years old through hospital-based surveillance in Singapore.   "
253875|NCT01177852|"     Multicenter clinical trial, phase III, controlled by active medicine, open, randomized,     enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway     characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no     more than 5 consecutive days (without systemic/topic use of medication during this period)     followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny     nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel     groups, and will receive the medicines of study, according of the randomization.   "
253876|NCT01177865|"     RATIONALE: Gathering information about patients with prostate cancer may help doctors learn     more about how patients choose treatment options.      PURPOSE: This study is looking at treatment choice in patients with localized prostate     cancer.   "
253878|NCT01177904|"     There seems to be a general consensus on the supplementation of progesterone (P4) for luteal     phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there     is no agreement about the precise duration of LPS.   "
253879|NCT01177917|"     This clinical trial will help determine if prebiotics can increase mineral absorption in     babies   "
253883|NCT01177969|"     Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders,     causing substantial distress and impairment over and above the autism spectrum diagnosis     alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically     developing youth with an anxiety disorder and when adapted, shows promise in children with     ASD and comorbid anxiety. However, there is currently no psychotherapy protocol tailored to     meet the unique needs of young adolescents with Autism spectrum disorders (ASD) and comorbid     anxiety. Given this, the present study seeks to develop and test a new CBT therapy in     adolescents with autism and comorbid anxiety.   "
253905|NCT01178255|"     To assess the two components of individualized homeopathic treatment for acute depression,     i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to     investigate the effect of different approaches to the homeopathic case history taking(defined     in this study as case history taking type I and II).   "
253884|NCT01177982|"     Objectives: This project is a Stage II behavioral development study designed to answer     remaining critical questions necessary before disseminating Reinforcement Based Treatment     (RBT) to the larger treatment community. These questions focus on the levels of intensity of     RBT most efficacious for substance-using pregnant patients. Design: The proposed study     utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple     assignment randomized trial (SMART) design. Participants (N=220) will first be randomized at     treatment outset into either treatment-as-usual RBT or a reduced intensity RBT. All     participants will receive a subsequent randomization based upon an assessment of their     initial two weeks of treatment compliance. Early-non-compliant participants will be     randomized to receive either the same or an increased level of RBT treatment intensity while     early-compliant participants will be randomized to receive either the same or decreased level     of treatment intensity and scope. Primary outcome measures include treatment completion, and     maternal heroin, cocaine, and other illicit substance use. Secondary outcome measures include     maternal measures of HIV risk behavior, and psychosocial functioning and neonatal measures of     length of hospitalization, and birth outcomes. Significance: The proposed project's     innovation includes: the novelty RBT, use of a cutting-edge SMART model, application of     advanced statistical techniques and inclusion of a cost-effectiveness approach. The proposed     project's significance is exceedingly high, as it will lay the foundation for later Stage III     studies focused on dissemination of stepped care treatment programs for drug-addicted     pregnant women that can be implemented not only in comprehensive care clinics but in diverse     community settings that provide services to such women.   "
253885|NCT01177995|"     This study is a randomized outcome trial of a social network HIV prevention intervention for     at-risk labor migrants who have arrived in St. Petersburg, Russia, to seek work. Most come to     St. Petersburg from Moldova, Tajikistan, Uzbekistan, Ukraine, and other poor post-Soviet     republics. While living in Russia, labor migrants are also living in a city and country with     high HIV prevalence. Many labor migrants have limited awareness of AIDS, and most are living     in a location far from their spouses, family members, and others. For that reason, labor     migrants are vulnerable to risk behavior for contracting HIV.      This study hypothesizes that members of labor migrant social networks whose network leaders     are trained to deliver HIV prevention messages will exhibit greater reductions in sexual risk     behavior (unprotected intercourse with nonspousal partners) from baseline to 3- and 12-month     followup assessments than will members of social networks whose members receive standard,     individual HIV risk reduction counseling alone.   "
253886|NCT01178008|"     The proposed study is a randomized controlled trial to examine the efficacy and safety of     active acupuncture versus placebo acupuncture for the treatment of postpartum depression. The     investigators hypothesis is that active acupuncture would be superior to placebo acupuncture     in the short-term treatment of postpartum depression.   "
253887|NCT01178021|"     This is an open label two-arm randomized prospective study of two treatments for P. vivax     malaria. Patients meeting study inclusion criteria will be enrolled and allocated either     chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will     be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients     with recurrent P. vivax infection will be treated with the same medication as initially     randomized unless contraindicated. Recurrences in the two arms will be compared to estimate     the risk of and mean duration to relapse, classify the relapse pattern as early or late     relapse and to estimate the efficacy and safety of the study drugs.      Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish     between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be     collected on day 7 from each study subject as well as on the day of recurrence if within 8     weeks of chloroquine   "
253888|NCT01178034|"     Initiation of warfarin therapy is problematic. The investigators goal was to evaluate if a     new demographic/pharmacogenetic algorithm is better than a usual algorithm based on INR value     at day five after four days of 5 mg/day warfarin. To this end patients with atrial     fibrillation starting warfarin are randomized in two arms.   "
253889|NCT01178047|"     Sleep-wake disturbances (SWD) are frequent in Parkinson's disease (PD) and affect the quality     of life of affected patients.      Rasagiline is a potent, highly selective, irreversible, second-generation, monoamine oxidase     type-B (MAO-B) inhibitor with a 24h dopaminergic effect.      It is well known that dopaminergic treatment closely interacts with SWD. This study aims to     assess the effect of Rasagiline on SWD in PD patients. In this randomized, double-blind,     placebo controlled study in clinical phase IV, 60 subjects will be treated with rasagiline     1mg po once daily or placebo over 8 weeks. The study is planned to be conducted in 6-9 Swiss     centers. Questionaires will be used to assess SWDs: sleep disturbances (Parkinson's Disease     Sleep Scale, PDSS), daytime sleepiness (Epworth Sleepiness Scale, ESS), fatigue (Fatigue     Severity Scale, FSS), apathy (Apathy Evaluation Scale Self, AES-S), disability (Sheehan     scale) and QoL in PD patients.        -  Trial with medicinal product   "
253890|NCT01178060|"     The goal of this research is to improve communication to Veterans. The investigators want to     improve how doctors and nurses talk to patients about the risk of heart attack and stroke.     The investigators will give everyone in the study information about the risk for heart attack     or stroke. The investigators will also provide information on how to reduce this risk. This     information will be given in one of two ways. The investigators want to see which way of     giving information works better for veterans. The investigators also want to assess the     impact of personalized stroke risk communication to patients at risk for stroke on patient     knowledge, beliefs, and preferences for risk reduction behaviors and evaluate the impact of     personalized risk communication on medication adherence and blood pressure. The investigators     plan to enroll approximately 100 veterans for this study. All veterans will be from the     Durham VA Primary Care Clinics. The investigators will ask everyone to be in the study for 3     months.   "
253897|NCT01178151|"     In this pilot study the investigators will treat all patients known with Peutz-Jeghers     syndrome (PJS) who are diagnosed with advanced malignancies with everolimus 10mg daily until     disease progression. Most patients with PJS have an inherited LKB1 mutation leading to     aberrant m-TOR activity. Their risk to develop malignancies or intestinal polyps is probably     related to this constitutive mTOR signaling. The hypothesis is that mTOR inhibition is an     effective anticancer treatment in PJS patients with advanced malignancies.   "
253898|NCT01178164|"     Fabry disease (FD) is a rare X-linked multisytemic lysosomal disorder caused by     alpha-galactosidase deficiency. Globotriaosylcéramide (Gb3) deposits are observed in almost     all tissues examined. Signs of the disease appear earlier and are more severe in affected     males than in females. Myocardiopathy, renal failure and neurological signs including chronic     pain and peripheral neuropathies are the most frequent signs. The availability of two     enzymatic replacement therapies now provides a specific and effective treatment for patients.     The prevalence of FD is estimated between 1/40,000 and 1/117,000. The frequency of Fabry     disease has previously been estimated in several series of patients presenting one single     sign, ie renal failure, hypertrophic myocardiopathy and early onset stroke. However, no data     are available about the prevalence of FD in populations of patients suffering from chronic     pains of unknown origin.      The diagnosis of FD will be performed by standard procedures following international     recommendations. These require the search for a deficiency of alphagalactosidase A activity     on leucocytes in males and genetic analysis of the GLA gene in females (Lidove et al. 2007).      The patients in whom the diagnosis of FD is established during this study, will be call in     for an additional visit in the Investigating Centre in order to confirm the diagnosis and     propose suitable assessment and care.   "
253899|NCT01178177|"     Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects     recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced     neutropenia.Although both of these populations are at high risk for IPA, they differ with     regards to the specific defects in host defense mechanisms that increase their risk for IPA.     Chemotherapy- induced neutropenia is the principal defect affecting patients with hematologic     malignancies, whereas transplant recipients tend to have dysfunctional T cells and     phagocytes, as a result of immunosuppressive drug therapy. Thus, the patterns of IPA-related     infection and inflammation may differ according to the type of underlying immune defect.     Although the clinical and radiological features of IPA in patients with neutropenia have been     extensively studied, little is known about the characteristics of IPA in SOT recipients. The     investigators therefore compared the IPA- related clinical and radiological findings in SOT     recipients with those of neutropenic patients.   "
253900|NCT01178190|"     Narrow band imaging (NBI) videobronchoscopy is an optical technique in which filtered light     enhances superficial neoplasm based on their neoangiogenic pattern. The objectives of this     study investigate its better diagnostic yield in the assessment of lung cancer than     conventional flexible bronchoscopy.   "
253901|NCT01178203|"     Aim: eliminating or reducing pain following endodontic treatment is of great importance. The     aim of this study is to compare the effects of Tramadol, Novafen and Naproxen on     post-operative pain following instrumentation of root canals in teeth with irreversible     pulpitis. Sample size: one hundred patients considering the inclusion and exclusion criteria     were selected. Intervention and outcome: The effect of Tramadol, Novafen and Naproxen on     post-operative pain following instrumentation of root canals in teeth with irreversible     pulpitis was evaluated.   "
253902|NCT01178216|"     Organ transplantation offers the only hope for a normal life for patients with end-stage     renal disease on dialysis (ESRD). For patients with antibodies to human leukocyte antigens     (HLA), transplantation is extremely difficult or impossible since pre-formed antibodies will     cause severe rejection and loss of transplanted organs. Intravenous gamma globulin (IVIG) can     reduce or eliminate these antibodies in most patients and allow for successful     transplantation. This breakthrough has allowed patients previously considered not     transplantable to receive life-saving transplants. However, IVIG alone does not always     eradicate the anti-HLA antibodies to a degree that will allow transplantation to proceed.      In this study, the investigators propose to add an additional treatment (Rituxan), a     humanized antibody directed at the CD20 antigen that is present on most B-cells (B-cells make     antibodies, this Rituxan should help eliminate the source of anti-HLA by deleting the cells     that make it).      Both IVIG and Rituxan are approved by the U.S. Food and Drug Administration (FDA) for     numerous immunologic disorders and Non-Hodgkin's lymphoma, respectively. However, neither is     yet approved by the FDA for desensitization of highly-HLA sensitized transplant patients.      Previously conducted pilot study demonstrated that IVIG + Rituxan can fill an important gap     in our current therapeutic approach for management of highly sensitized patients and it may     become the standard approach to manage these patients.      This study has been recently updated after observation that subjects transplanted after     desensitization with IVIG alone experienced higher rates of antibody rejection and graft     loss.      The primary objective of this revised protocol will be to examine the safety and efficacy of     IVIG 2gm/kg (maximum dose 140g) given on day#0 & day #30 plus Rituximab 1gm given on day #15.     Transplanted patients will receive additional doses of Rituximab 1gm at 3 months     post-transplant if donor specific antibody (DSA)levels remain or become positive or at 6M if     de novo DSA occur. All transplanted patients who remain DSA negative, will not receive     additional Rituximab. All transplanted patients will have a protocol biopsy at transplant and     at 12 months. All subjects will have to complete 5 visits in a pre-transplant phase of the     study. Patients who are transplanted will have additional 5 post-transplant visits. The     following are research-related procedures:        1. Rituxan infusion.        2. Kidney allograft biopsy (Intra-op and 12 months post transplant)        3. Rituxan level, HACA levels        4. Immunologic biomarkers (CD19+, CD38+, CD27+)      Although Dr. Jordan commonly uses both treatment regimens at Cedars-Sinai Medical Center,     only the IVIG treatment is considered to be standard of care for highly HLA-sensitized     patients. The investigational component of this study is the addition of the Rituxan and     currently the study has been ammended to a safety and efficacy study focusing on decreasing     HLA antibodies pre-transplant and minimizing DSA post transplant.   "
253903|NCT01178229|"     Objective: to evaluate the effects of physiotherapy on the anteroposterior airway size in a     group of bruxist children      Question: Is a physiotherapeutic technique aiming at changing the head posture, effective to     increase the anteroposterior dimensions of the upper airway in bruxist children?      Hypothesis: The bruxist children treated with physiotherapy will present higher airway     dimensions      Design: randomized clinical trial with allocation and blinding of the examiners.      Participants: 3 to 6 year old children with complete primary dentition, dental and skeletal     class I occlusion. The participants were classified as bruxist according to the minimal     criteria of the ICSD for bruxism. The children were randomized in an experimental (n=13) and     a control (n=13) group.      Intervention: A physiotherapeutic intervention using the Awareness through movement technique     was applied to the children of the experimental group once a week, until 10 sessions were     completed.      Outcome measures: anteroposterior measurements of the nasopharynx, oropharynx and hypopharynx     taken in a lateral cephalogram with standardized techniques.   "
253904|NCT01178242|"     The purpose of this study is to evaluate salivary gland and labial mucous membrane     transplantation in patients with severe symblepharon and dry eye secondary to Stevens-Johnson     Syndrome (SJS).   "
253907|NCT01178281|"     The objective of this study is to determine whether pomalidomide is safe and effective in     reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative     neoplasm (MPN)-associated myelofibrosis. (Global Study) and to describe the frequency of     anemia response to pomalidomide in Chinese participants with MPN-associated myelofibrosis and     severe anemia not receiving REC-transfusions (China Extension Study only)   "
253908|NCT01178294|"     This study is to test whether the study drug (OBI-1) is safe and effective for the treatment     of serious bleeding episodes in people with acquired hemophilia A.   "
253909|NCT01178307|"     The goal of this research study is to better understand the symptoms experienced by patients     with GIST.      There are 3 parts to this study. In Part 1, participants will complete 1 set of interviews     and questionnaires about GIST symptoms. In Part 2, the importance of some symptoms to     patients with GIST will be rated by doctors, nurses, patients, and family caregivers. In Part     3, participants will complete questionnaires about GIST symptoms over 1 year.      You are being asked to take part in Part 3 of the study.   "
253910|NCT01178320|"     Heart attacks and strokes caused by the unstable atherosclerotic plaques remain the leading     cause of death in the United States. Unstable plaques often have more fat than stable     plaques. This study will investigate if a treatment with LDL-lowering plus HDL-raising     compared with LDL-lowering alone would more effectively reduce the plaque fat content     assessed by magnetic resonance imaging (MRI), therefore, further reducing heart attacks and     strokes.   "
253911|NCT01178333|"     HIT-RADIO is a study of patients who had a positive heparin PF-4 antibody test between     1/21/2008 and 9/25/2008 at selected hospitals. The study will collect and analyse information     that is already in the patients' medical records. Information about laboratory values (such     as platelet counts), treatments (such as medications), and outcomes (such as blood clots,     amputation, and death) will be included.   "
253912|NCT01178346|"     The purpose of this study is to look at pharmacoeconomic data for subjects that have received     either NicVAX or placebo in the Nabi-4514 or Nabi-4515 studies.   "
253913|NCT01178359|"     Despite advances in cardiac arrest resuscitation survival from cardiac arrest is less than     20-30% and new therapies are urgently needed. Sodium nitrite infused during resuscitation     from cardiac arrest has recently been shown to improve survival in a mouse model of cardiac     arrest and our group is eager to test this hypothesis in a clinical trial. Our overall     hypothesis is that an infusion of 2 μmole/kg sodium nitrite during resuscitation will     increase the proportion of patients who will survive cardiac arrest. In preparation for a     clinical trial, preliminary safety and efficacy data (phase 1) is needed which is the primary     goal of this study.   "
253914|NCT01178372|"     Hepatic encephalopathy (HE), a challenging complication of advanced liver disease, occurs in     approximately 30-45% of patients with cirrhosis. The treatment of choice is non-absorbable     disaccharides, such as lactulose and lactitol.Probiotics are effective in the treatment of     minimal hepatic encephalopathy which precipitates hepatic encephalopathy. The investigators     will assess the effects of lactulose and probiotics for the prevention of recurrence of HE     (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic     encephalopathy.   "
253915|NCT01178385|"     Autism spectrum disorders affect as many as 1 out of 150 children and are related to     significant impairment in social, adaptive, and school functioning. Co-occurring conditions,     such as anxiety, are common and may cause substantial distress and impairment beyond that     caused by the autism diagnosis. Although effective interventions have been developed for     typically developing youth with anxiety disorders, this approach needs to be adapted for     children with autism. Accordingly, we are proposing a randomized controlled trial to examine     the effectiveness of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with     autism spectrum disorders and comorbid anxiety disorder(s).   "
253916|NCT01178398|"     Many pregnant women in the US do not consume enough docosahexaenoic acid (DHA), an essential     nutrient found in fish. Apparently conflicting findings that fish consumption is beneficial     for the developing fetus, yet potentially toxic because of mercury contamination, have     created uncertainty about the appropriate fish consumption advice to provide pregnant women.     The investigators objective was to determine knowledge, behaviors, and received advice     regarding fish consumption among pregnant women who are infrequent consumers of fish.   "
253917|NCT01178411|"     This is an extension study that will allow patients to continue to receive study treatment     when the original studies into which they were enrolled have reached their designated     end-dates.   "
253918|NCT01178424|"     Major depressive disorder (MDD) continues to have a profound impact on individuals, families,     and the health care system. Despite marked success in treating active individual episodes of     unipolar depression, our understanding of the neural and cognitive mechanisms involved in the     return of symptoms remains extremely limited, and few interventions exist that specifically     target factors involved in prophylaxis. The research being proposed is among the first that     is designed to examine neurocognitive markers for depressive relapse vulnerability and link     them directly to clinical prognosis.      Hypothesis 1: Cortical midline structures (CMS) network recruitment will be associated with     behavioural and neural indices of a reflexive attentional bias towards dysphoric stimuli in a     divided attention task.      Hypothesis 2: Behavioural and neural indices of dysphoric attentional bias following mood     challenge will predict depression relapse in prospective 18-month follow up.      Hypothesis 3: Relative to CBT, Mindfulness Based Cognitive Therapy (MBCT) will normalize CMS     and right insular/fronto-opercular cortices (INS-FO) network imbalance.      Hypothesis 4: Relative to CBT, MBCT will normalize to healthy control levels, behavioural and     neural indices of dysphoric attentional bias, which will be predictive of reduced relapse     risk across a 24 month follow up.   "
253919|NCT01178437|"     The aim of the study is to prove the feasibility and safety of transcutaneous, electrical     stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.   "
253920|NCT01178450|"     The hypothesis of this study is that subtotal parathyroidectomy using minimally invasive     surgery is superior to cinacalcet for the treatment of persistent secondary     hyperparathyroidism (HPT) post renal transplant, with minimal morbidity and significantly     reduces the cost of treatment post transplant.   "
253921|NCT01178463|"     The researchers hypothesized that nonobstructive azoospermia might be associated with a     reduction OF SSCs in seminiferous tubules as compared with obstructive azoospermia.     Testicular sperm specimens that had been previously extracted from azoospermic patients will     be paraffin embedded and stained with anti GPR-125. After antigen retrieval, the sections     will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary     antibodies. Those found to be SSCs will be counted using light microscopy, and compared     between patients with obstructive (n=11) and non-obstructive azoospermia (n=9).   "
253922|NCT01178476|"     Hypoglycaemia is the most common acute complication in insulin-treated diabetes. The fear of     hypoglycaemia discourages diabetic subjects from the attempt to maintain tight glycemic     control, which in turn leads to increased diabetes related morbidity and mortality.      Neuroglycopenic hypoglycaemia in insulin-treated diabetic patients is associated with     characteristic changes in EEG with a decrease in alpha activity and an increase in delta and     theta activity. We have recently demonstrated that hypoglycaemia-associated EEG-changes can     be recorded from subcutaneously placed electrodes using an automated mathematical algorithm     based on non-linear spectral analysis. Experimental findings hold promises that an alarm,     given at the time of EEG-changes, can help the patients to avoid severe hypoglycaemia by     ingestion of carbohydrate.      This is the first larger scale trial testing the clinical applicability of a     hypoglycaemia-alarm based on real-time analysis of EEG-signals.   "
253923|NCT01178489|"     To clarify patient related problems in the Post Anaesthetic Care Unit (PACU) immediately     after fast-track hip and knee arthroplasty.   "
253924|NCT01178502|"     To develop and validate the predictive warfarin dosing algorithm.   "
253925|NCT01178515|"     Substituting whole milk intake for defatted milk will improve indicators of cardiovascular     risk, i.e. total cholesterol, triglycerides, Low Density Lipoprotein (LDL) and High Density     Lipoprotein (HDL)cholesterol, apolipoproteins: ApoB100, Lp(a) and ApoA in a sample of Mexican     children 6-13 years of age.   "
253926|NCT01178528|"     Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological     interventions have been proven effective in improving exercise capacity. At the presence     there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity.     Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left     ventricular dysfunction and heart rate > 70 bpm. The association of ivabradine and atenolol     has been proven effective in increasing exercise tolerance in patients with ischemic heart     disease. Aim of the present study is to evaluate the effect of heart rate reduction with     ivabradine, carvedilol or their combination in patients with heart failure of ischemic     origin.   "
253927|NCT01178541|"     Study designed to measure simultaneously the width of both lateral ventricles of the fetal     brain. Thus, will enable to evaluate the normal asymmetry that may exist between the right     and the left ventricles during the pregnancy.   "
253928|NCT01178554|"     The Clinic Treatment Project tested two alternative methods of delivering evidence-based     practices within public community-based mental health clinics, using training and supervision     procedures designed for the settings and users.   "
253929|NCT01178567|"     Comparison of Pulmonary Complications related to laparoscopic sleeve gastrectomy and     laparoscopic adjustable gastric banding.   "
253930|NCT01178580|"     Community acquired pneumonia (CAP) is still one of the most important causes of morbidity in     adults. (1) In severe cases, parapneumonic effusions or empyema may develop. In these     patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response     as seen in sepsis.      The aim is to study the fibrinolytic activity in patients with CAP alone versus CAP with     parapneumonic effusions with and without empyema.   "
253931|NCT01178593|"     This randomised controlled trial (RCT) aimed at assessing the efficacy of hypnotherapy in     group sessions (GHT) with a 12-months follow-up.   "
253932|NCT01178606|"     Sonographic coronal section in the lateral fetal ventricles shows echogenic area in the     ventricles borders creating an halo around the ventricles. Histologically this area     correlates to the Stratified transitional field. In this study we would like to measure this     area for the purpose of creating a nomogram.   "
253933|NCT01178619|"     Intrauterine growth restriction is being suspected in cases where the fetal estimated weight     is less then the 10 th percentile for its gestational age. Abdominal circumference is the     most influenced measurement in this cases. Head circumference on the other hand can be or not     be influenced. Previous studies have shown that transverse cerebellar diameter (TCD) is     constant to gestational age and is not influenced by IUGR.Other showed lower TCD in IUGR     fetuses. We would like to study the differences in cerebellar, vermian and corpus callosum     growth between normal to IUGR fetuses and between symmetrical and asymmetrical IUGR. In this     observational study we will include pregnant women between 28-37 gestational week with a     singleton otherwise normal pregnancies. We will measure the fetal TCD, vermian distances and     the CC, abdominal circumference, head circumference and femur length. we will compeer these     measurements according to the following groups:normal fetuses, symmetrical and asymmetrical     IUGR.   "
253934|NCT01178632|"     Phase III, double blind, randomized study, controlled by Valeriana officinalis L for     evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and     Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and     be followed by a post treatment visit.   "
253935|NCT01178645|"     The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide,     cytarabine and melphalan (BuEAM) as a conditioning for autologous stem cell transplantation     in patients with non-Hodgkin lymphoma.   "
253936|NCT01178658|"     The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide,     cytarabine and melphalan (BuEAM) as a conditioning for autologous stem cell transplantation     in patients with non-Hodgkin lymphoma.   "
253970|NCT01179100|"     This study will evaluate the effect of intraoperative lidocaine infusion on postoperative     orientation and concentration in elderly patients having general anesthesia for orthopedic     surgeries requiring a minimum 2 days hospitalization.      This study will also aim to determine whether intraoperative lidocaine infusion during     general anesthesia improves recovery and patient outcome, as well as to determine whether     lidocaine infusion decreases postoperative opioid (pain medication) usage.   "
253937|NCT01178671|"     The overall goal of this study is to examine the efficacy of the combination of mirtazapine     and sertraline in the treatment of posttraumatic stress disorder (PTSD). Sertraline is     FDA-approved for PTSD, but it is often not fully effective. The combination of mirtazapine     and serotonin reuptake inhibitors like sertraline has appeared highly effective in a related     disorder -- depression.      In this study, sixty patients with chronic PTSD will be randomized to treatment with either     sertraline + mirtazapine or sertraline + placebo for 12 weeks. Patients who show at least a     minimal response after 12 weeks will continue for another 12 weeks on the same treatment.   "
253938|NCT01178684|"     This study will provide the range of Epidermal Nerve Fiber Density (ENFD) typically seen in     Thai individuals. ENFD values from Thai HIV-negative subjects without neuropathy will be used     as appropriate reference norm for Thai HIV-positive subjects. In particular, comparison of     ENFD values from Thai HIV-negative subjects with baseline ENFD values in Thai HIV-positive     subjects prior to highly active antiretroviral therapy (HAART) will allow examination of the     effect of HIV per se on ENFD. ENFD from Thai HIV-positive subjects on long-term d4T     (stavudine) with and without neuropathy will also provide reference ENFD values at the     extremes of the disease process i.e. extent of ENFD decrease in subjects with d4T-induced     symptomatic neuropathy and in subjects completely free of disease despite d4T treatment for     comparison with Thai HIV-positive subjects on short-term d4T in SEARCH 003 study.   "
253939|NCT01178697|"     This randomized clinical trial is conducted to evaluate the effect of three intravitreal     injections of bevasizumab versus two intravitreal injections of triamcinolone in acute     central retinal vein occlusion. The outcomes are visual acuity and central macular thickness.     The follow-up time is 6 months.   "
253940|NCT01178710|"     It is well know that statins have been used to low cholesterol to prevent and treat coronary     artery disease for many years. It was also reported that statins could protect endothelial     function and cardiac function during coronary artery bypass graft. However, some results were     controversial. Also, there is no clinical data available on statin cardiac protection during     surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are     trying to see whether statins can protect heart injury during cardiac surgery in Chinese.     Part of patients will receive statin treatment and part of will not before surgery in the     study. Both patients' heart function will be measured and compared after surgery to determine     whether statins can protect heart injury during heart surgery.   "
253941|NCT01178723|"     Studies has found a connection between breakfast consumption and obesity and obesity-related     complications, but only few studies examined the effect of breakfast size.      The purpose of this study is to examine the effect of breakfast size on several parameters in     adults with Type 2 diabetes mellitus.   "
253942|NCT01178736|"     The purpose of this study is to implement a community-based combined program for early     detection of breast, cervical, ovarian and endometrial cancer in low-resource countries     delivered through a free standing or a mobile Well Woman Clinic. The goals of this program     are to downstage cancers and improve mortality rates using low-cost early detection methods.     These programs will be implemented in regions where early cancer detection strategies are not     in place and cancers present at advanced stages with resultant high mortality. Currently,     there are three target project sites: Cambodia (June 2011), India (June 2011), and Brazil     (March 2011). Memorandums of Understanding have been secured with local health organizations     in each region to establish clinic operations. Each clinic would serve an approximate target     population of 100,000 amongst whom about 12,000 eligible women (4-5,000 annually) will be     invited to be screened for breast and cervical cancer over a three-year time span.   "
253943|NCT01178749|"     The aims of this three-year study are to explore symptom experience and its related factors     for the patients with chronic hepatitis C Infection receiving interferon-α with ribavirin for     24 weeks and further to predict the relative risk of failure or occurence of severe side     effects which interrupt the treatment.   "
253944|NCT01178762|"     Chlamydia trachomatis is one of the major causes of sexually transmitted disease and also the     leading infectious cause of blindness in the world.Treatment of C. trachomatis eye infection     has involved for a long time. The efficacy of single dose azithromycin has already been     demonstrated as effective in the treatment of both trachoma and adult inclusion     conjunctivitis.However, in our clinical experience, some patients of chlamydial     conjunctivitis may require augmented single dose azithromycin treatments before C.     trachomatis is eradicated. In this way, we would like to known the efficacy of single dose     and augmented single dose azithromycin in the treatment of chlamydial conjunctivitis.   "
253945|NCT01178775|"     The aims of this three-year study are to:        1. develop and validate a perceived meaning of fatigue scale        2. examine the effect of individualized patient education and walking programs on          alleviating fatigue in patients with gastric or colorectal cancer,and further explore          the relationship between the perceived meaning of fatigue and intervention outcome.   "
253946|NCT01178788|"     Objective: This trial would evaluate the clinical effectiveness of Progesterone(P) and     17-hydroxy Progesterone (17P) in reducing PTD, in symptomatic women at risk because of     cervical shortening, in the present pregnancy.      Main outcome: Delivery before 37 weeks.      Secondary outcomes: Gestational age at delivery, Delivery <32, <35 wks, hospital admissions     before delivery, birth-weight centile, NICU admission, days of NICU admission, days of oxygen     supply, composite neonatal complications, congenital neonatal malformations and anomalies.      Allocated treatments will be:      Group A: 17P 341 mg i.m./weekly (Lentogest, AMSA, Italy); Group B: micronized P 200 mg per     vagina /day (Utrogestan, Besins Healthcare, Belgium) Group C: no treatment, clinical     observation      Concomitant treatments: Iron and folic acid supplementation, and Betamethasone (12 mg     repeated once 24 hours apart) will be permitted. Is not allowed the treatment with tocolytics     per os. Any treatment will be recorded.      Duration: The period of enrollment is 15 months. Cases not randomized by a clinical unit will     be competitively assigned later. Results are expected 20-24 months from starting.      Sample Size: hypothesizing a risk of PTD = 0.30 efficacy is defined as a reduction to 50%     (risk = 0.15). With a test potency = 0.80 and alpha = 0.025 study needs to enrol 160     patients/arm, with a total of 480 patients.      Data analysis: Methodological Unit will assign randomized treatment through a web site and it     will collect data through the same way.   "
253947|NCT01178801|"     As a result of increasing adoption of health information systems in hospitals, more and more     health records can be gathered and accumulated in the healthcare data repository. For this     reason, the opportunity of analyzing and mining the healthcare data for quality improvement     is increasing and becoming more and more important.      The purpose of the project is to gather the clinical data relevant to liver cancer, and adopt     the knowledge discovery and mining modules in information technology (IT) for analyzing and     discovering the knowledge from the gathered clinical data.      We can analyze the gathered clinical data for comparing the outcomes of different treatment     strategies, finding out new diagnosis and staging criteria and factors, and other hidden     knowledge included in the clinical data.      Afterwards, the discovered results and the mining algorithms can be shared though the     sharable knowledge mining platform provided by our project.   "
253948|NCT01178814|"     This is a prospective trial of Revlimid for subjects who have a blood cell cancer called     myelodysplastic syndrome (MDS). Cells in their marrow make proteins through messages that are     carried from the genes. The amount of the message tells researchers if the protein it is     going to make is high or low. This is known as expression of genes. The purpose of this study     is to conduct a prospective trial testing the idea that expression of specific genes can help     to predict which patients will respond to study drug administration with Revlimid     (lenalidomide).   "
253949|NCT01178827|"     This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®)     and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with     overactive bladder and age associated memory impairment.   "
253950|NCT01178840|"     This is a comparative, open-label two-period crossover study of up to 505 couples comparing     the PATH Woman's Condom to the FC2 female condom. California Family Health Council will     enroll up to 505 couples to have 375 complete both periods. The study will provide data on     functional performance, vaginal semen exposure, safety, and acceptability of the two female     condoms.      Both partners will be required to come to the clinic to be consented for the study. If both     members of the couple meet all eligibility requirements, they will each sign an informed     consent form and will be enrolled as a couple. The couples will be randomized to one of two     female condom use sequences for the two periods (WC then FC2 or FC2 then WC). For the first     period of 2-4 weeks, the couple will be asked to have sex once without a condom and 4 times     using the first assigned female condom. For the second period of 2-4 weeks, the couple will     be asked to have sex 4 times using the second assigned female condom. In the first period,     the couple will have one act of unprotected sex for which they will collect pre- and     post-coital vaginal swabs. The couple will also use 4 female condoms of the assigned type.     They will be asked to collect pre- and post-coital vaginal swabs and a post-coital swab from     the condom interior. The couple will complete a detailed Condom Use Questionnaire together     after each condom use. An Acceptability Questionnaire will be completed separately by males     and females at the end of each study period. Couples may have additional acts of sex during     each period as they desire but will not have sex at least 48 hours prior to each study sex     act. After a follow-up visit, the procedures will be repeated with 4 of the second assigned     condom type but without the collection of vaginal swabs at unprotected intercourse. Each     couple will be enrolled for about 2-3 months, depending on the intervals between sex acts.     Clinicians evaluating product-relatedness of AEs will be blinded to the condom type used.     Male partners will be requested to attend the final visit, and, if they experience adverse     events, the followup and/or unscheduled visits.   "
253951|NCT01178853|"     This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug     interaction study.   "
253952|NCT01178866|"     Evaluate less employed markers of tissue hypoperfusion as venoarterial carbon dioxide partial     pressure difference (ΔPCO2) and estimated respiratory quotient (eRQ) combined to other     classically studied markers as predictive factors of complicated clinical course after     cardiac surgery in patients with left ventricular dysfunction.   "
253953|NCT01178879|"     The purpose of this study is to determine whether telehealth nursing consultations of chronic     obstructive pulmonary disease (COPD) patients are superior to hospital readmissions.   "
253954|NCT01178892|"     This study is the second clinical trial to be conducted by the Menopause Strategies - Finding     Lasting Answers for Symptoms and Health (MsFLASH) research network, a group of investigators     conducting clinical trials designed to find new ways to alleviate the most common, bothersome     symptoms of the menopausal transition.      In this twelve-week clinical trial, 374 women aged 40-62 who are in the late menopausal     transition or postmenopausal and experiencing bothersome hot flashes will be randomized to     one of three behavioral intervention groups: yoga, exercise, or usual activity. All women     will simultaneously be randomized to receive omega-3 supplementation or a matching placebo.      The primary aims of this trial are to compare the magnitude of changes in perceived,     self-reported frequency and bother of vasomotor symptoms (VMS) before and after the     intervention between yoga and the usual activity comparison group, between exercise and the     usual activity comparison group, and between omega-3 fatty acid supplementation or placebo.     The hypotheses to be tested are:        1. Women assigned to yoga will report lower frequency and less VMS bother than women          assigned to the usual activity group at the end of a 12-week study period.        2. Women assigned to aerobic exercise at moderate-vigorous intensity will report lower          frequency and less VMS bother than women assigned to the usual activity group at the end          of a 12-week study period.        3. Women assigned to omega-3 fatty acid supplementation will report lower frequency and          less VMS bother than women assigned to the placebo group at the end of a 12-week study          period.      The omega-3 component of the study is double-blinded. For yoga, exercise, and usual activity,     the outcomes assessors are blinded to the randomization assignments.   "
253955|NCT01178905|"     To evaluate, in a prospective multicenter study, ultrashort-term heat inactivation for the     prevention of Cytomegalovirus (CMV) transmission in preterm infants (<32 weeks gestational     age or <1500 g birth weight) under clinical conditions. Inactivation will be done only during     the period of infectivity of breast milk, characterized by viral excretion strongly     associated with subsequent infection, monitored by periodic virologic examinations of BM and     urine of the infant. Thus the investigators hypothesis is that no CMV transmission through     breast milk will occur using a gentle ultrashort heat inactivation procedure applied to     infective breast milk.      The protocol has been approved by the ethics committee of Tuebingen University Hospital.   "
253956|NCT01178918|"     This is a prospective observational study with recruitment of healthy volunteers from     consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and     Allergic Diseases, Golnik, Slovenia.      The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1     vaccines.   "
253957|NCT01178931|"     The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and     the vaginal progesterone, used for luteal phase support.      (Initial start date was January 2009 but not for patients' recruitment only for paper work,     documents, team organization, statistical pre-work actions and to gain the official approval     of Institutional Review Board. The recruitment started in October 2010 and continued until     October 2013.)   "
253958|NCT01178944|"     This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients     with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by     surgery or has spread from the primary site (place where it started) to other places in the     body. Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Giving pralatrexate with oxaliplatin may be an effective     treatment for esophageal, stomach, or gastroesophageal junction cancer.   "
253959|NCT01178957|"     The purpose of this study is to estimate the acute effect of hyperglycemia on     Very-Low-Density-Lipoprotein-triglyceride(VLDL-TG) secretion.   "
253960|NCT01178970|"     The aim of the study is to prevent falls related to poor lower body strength adn balance in     the elderly.   "
253961|NCT01178983|"     In the recent decades, with technology development, computer workstation has become     fundamental both at work and at home environments, and is now used routinely for many     purposes. Musculoskeletal disorders (MSD) are most often characterized by backaches, neck and     upper extremities pain, discomfort and pain in joints, muscles and soft tissues. Since it has     been found that many musculoskeletal disorders are connected, among others, to biomechanical     and psychosocial factors relating to a person's work environment, the literature refers to     them as Work Related MSD (WRMSD). Risk factors correlated with WRMSD include repetitive     motions, awkward positions or static muscle loading over prolonged periods of time, use of     high keystroke force, direct mechanical pressure, vibration and extreme temperatures.     Computer operators found to be sitting statically for a long time in front of the computer     and keyboard, with limited options of changing body position. Psychosocial factors have also     been implicated in the workstation musculoskeletal disorders with computer operators. Workers     with WRMSD may suffer from persistent pain, loss of function and work disability. Therefore,     it may include changes in the employment and earnings for injured workers. The complex nature     of these injuries suggests that workplace rehabilitation interventions are a crucial aspect     of treatment management.      The main objective of this study is to explore the use of biofeedback intervention, based on     tele-rehabilitation principle, with computer operators suffer from WRMSD. Treatment efficacy     will be tested by use of RULA (Rapid Upper Limb Assessment) method. Data analysis will be     done by ANOVA Repeated Measures.      Hypothesis: Biofeedback intervention, based on tele-rehabilitation principle, will be found     effective with computer operators suffer from WRMSD.   "
253962|NCT01178996|"     The purpose of the study was to determine safety and efficacy of 48 weeks treatment with     Thymosin alpha 1 (Talpha1) in combination with pegylated interferon (PEGIFN) alpha2a and     ribavirin (RBV) in adult patients with chronic hepatitis C (CHC) already treated with, and     not responding to previous courses of PEGIFN alpha plus RBV combination therapy, in     comparison with a concurrent group treated with PEG IFN alpha2a in combination with RBV and     placebo.   "
253963|NCT01179009|"     Treatment resistant depression (TRD) is a major public health problem. Current therapeutic     options for this patient population remain limited. With all available treatments, only a     sub-set of those patients who achieve an antidepressant response are likely to achieve     treatment-induced remission. The need for antidepressant medication that can provide both     rapid and long lasting relief of TRD symptoms is widely recognized. There is new evidence     that drugs that block NMDA glutamate receptors (NMDA antagonists) are promising candidates     for meeting this need. Existing studies in TRD have used only a low-dose, brief infusion of     ketamine that would not be expected to re-sensitize the NMDA receptor; in agreement with this     theory, these prior studies have found only temporary improvements of depression. Our key     hypothesis is that a higher-dose, longer-term ketamine infusion, such as that used in chronic     pain studies, would provide a more robust and lasting improvement from depression.      Accordingly, we will be test whether a 100-hour ketamine infusion would be more effective     than the standard 40-minute ketamine infusion currently used in other TRD studies. We will     randomize subjects to one of 2 arms: (1) 100-hour (+/- 4 hours) ketamine infusion plus     clonidine for the entire infusion (2) 40-minute ketamine infusion (plus clonidine) following     a 100+/- hour saline infusion. All subjects will receive clonidine, an alpha-2 agonist, to     minimize side effects of ketamine (namely, brief/mild psychotic and cognitive symptoms).      A subset of 20 patients with TRD will receive a 100-hour (+/- 4-hours)ketamine infusion with     head MRIs pre (2) and post (1) infusion. Little research has been done on the mechanism of     ketamine's putative antidepressant action. There is now a consensus that, in early stages of     the novel treatment development for depression, clinical studies should be paired with     mechanistic studies (neuroimaging) to understand the underlying mechanism and validate this     as a treatment target. Ketamine is thought to have an antidepressant effect by increasing     synaptic connections and therefore increasing connectivity in critical cognitive/emotional     circuits.   "
253964|NCT01179022|"     Incidence of Bacteremia Following Argon Plasma Coagulation in Patients with Endobronchial     Lesions   "
253965|NCT01179035|"     The purpose of this study is to study the effectiveness of the Transitions Clinic, a     post-release clinic for parolees with chronic medical conditions, in achieving increased     primary care engagement, lower rates of inappropriate hospitalizations, psychiatric emergency     service and emergency department use, and decreased recidivism.      We hypothesize that subjects receiving parolee-targeted care in the Transitions Clinic will     have increased rates of non-emergency department ambulatory care and outpatient mental health     care, lower rates of hospitalization, psychiatric emergency service (PES) utilization,     emergency department (ED) utilization, decreased total hospital length of stay, and decreased     recidivism compared to patients receiving primary care from other safety-net providers.   "
253966|NCT01179048|"     This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this     trial is to determine the long term effect of liraglutide on cardiovascular events in     subjects with type 2 diabetes.   "
253967|NCT01179061|"     The apelin-APJ system is a recently discover hormone system that has several important     actions in the cardiovascular system. Apelin causes the heart pump with more force and also     causes blood vessels to relax. Studies to date show that people with reduced pumping function     of the heart have lower levels of apelin in the bloodstream compared to people with normal     heart function. We have previously given apelin to healthy volunteers and people with reduced     pumping function and this increases the heart's contraction. However, this has only been     assessed over a short time period, around fifteen minutes, and we now want to know if this     effect is seen over a longer period.   "
253968|NCT01179074|"     To assess the benefits of oesophageal stenting and external beam radiotherapy over     oesophageal stenting alone in patients with inoperable oesophageal cancer   "
253969|NCT01179087|"     The purpose of the study is to investigate the prevalence, clinical predictors and     consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung     transplant recipients.   "
253972|NCT01179126|"     Multivessel disease has been reported to occur between 40 and 60% of patients with ST-segment     elevation myocardial infarction (STEMI) and has been associated to a worse prognosis.     Multivessel revascularization offers a myriad of potential advantages as enhance of the     collateral blood flow, greater myocardial salvage, the stabilization of other lesions that     can be potentially vulnerable, and the achievement of a complete revascularization, factor     that is associated with a better prognosis. On the other hand, the prolongation of procedural     duration, the hazard of contrast induced nephropathy and the peri-procedural complications     can limit the widespread of this practice.      To date, very few observational studies have focused in the multivessel revascularization     with disparity of results. Whereas ones have observed an increase of adverse cardiovascular     events and thus not recommend it, others have shown neutral results.      Stress echocardiography has been shown to be an adequate technique for the diagnosis of     coronary artery disease and could be an appropriate tool for selecting the lesions that need     to be revascularized because they induce large areas of ischemia. However, this technique has     also limitations like the high operator-dependence.      Therefore, the investigators sought to study if the complete multivessel revascularization of     patients with STEMI treated by means of primary percutaneous coronary intervention (PCI) has     an impact on prognosis compared to a strategy of treating only those non-culprit lesions that     produce large areas of ischemia in a stress test.   "
253973|NCT01179139|"     The purpose of the study is to better understand the causes of chronic rhinosinusitis     (CRS)and to determine if being around secondhand cigarette smoke causes swelling in the     sinuses. To answer this question, we are inviting healthy volunteers, volunteers with chronic     sinusitis, and volunteers with chronic sinusitis with nasal polyposis to complete a     questionnaire and undergo a series of tests. These tests will measure their allergies, their     exposure to cigarette smoke and the swelling in their sinuses. We are asking you to take part     because you are in one of these groups. About 166 people will take part in this research     study. All subjects will be enrolled at Massachusetts General Hospital (MGH). The Flight     Attendants Medical Research Institute (FAMRI) and the Harvard Clinical and Translational     Science Center Harvard Catalyst) are paying for this study.   "
253974|NCT01179152|"     During the second week of September( week 38 of the year)there are recorded data of     exacerbation of asthma all over the world, including Israel. A short preventive treatment of     6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and     hospitalization.   "
253975|NCT01176539|"     The purpose of this study is to determine whether the respiratory rate provided by Kai     Medical Non-Contact Respiratory Rate Monitors are as accurate as that provided by the     currently used methods, including respiratory chest bands.   "
253976|NCT01176552|"     This prospective study assesses toxicity and potential efficacy of granulocyte-macrophage     colony-stimulating factor (GM-CSF), interferon (IFN) alpha and interleukin-2 (IL-2)     postoperatively in patients with high-risk renal cell carcinoma (RCC).   "
253977|NCT01176565|"     The specific aims of this study are to:        1. Definitively determine the therapeutic benefit of the intensive treatment relative to          the standard treatment in the proportion of patients with death and disability (mRS 4-6)          at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.        2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard          treatment in the subjects' quality of life as measured by EuroQol at 3 months.        3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard          treatment in the proportion of hematoma expansion (defined as increase from baseline          hematoma volume of at least 33%) and in the change from baseline peri-hematoma volume at          24 hours on the serial computed tomographic (CT) scans.        4. Assess the safety of the intensive treatment relative to the standard treatment in the          proportion of subjects with treatment-related serious adverse events (SAEs) within 72          hours.   "
253978|NCT01176578|"     The discovery of the role of endothelial progenitor cells (EPCs) and their involvement in the     cardiovascular complications of type 2 diabetes (T2DM) would quickly have a significant     impact on the millions of Americans who have T2DM. This project is designed to 1) determine     the mechanisms underlying EPC dysfunction in older, sedentary adults with T2DM compared those     with normal glucose metabolism and impaired glucose metabolism, and 2) determine if aerobic     exercise training is an efficacious therapy for EPC dysfunction in T2DM, and whether     improvement in EPC number and function translates to improved endothelial function, increased     capillarization, and improved glucose metabolism in T2DM.   "
253979|NCT01176591|"     The proposed research will focus on investigating the determinants and consequences of CAD     via measurement of physiological, behavioral and subjective effects of physiologic and     psychologic stress cues in CAD volunteers in the laboratory, and through examination of the     effects of the effects of Aprepitant, an NK1 antagonist, on the above effects. This study     will examine the effects of the above stress cues on cocaine and alcohol craving under acute     Aprepitant dosing, and under placebo conditions. The study is a within-subjects crossover     design using 24 subjects.   "
253980|NCT01176604|"     The goal of this study is to learn more about the patient experience, including any reported     side effects and possible benefit related to the use of the TheraSphere device for treatment     of liver cancer. Because treatment using the TheraSphere device must be designed specifically     for each patient, the treatment process will also be monitored.      The Humanitarian Use Device Program is for FDA approved device that is safe and provides     probable benefit.   "
253981|NCT01176617|"     The purpose of this study is to determine if continuous monitoring using an implantable loop     recorder (ie. a device that is placed just underneath the skin of the chest and monitors the     heart rate and rhythm) for a year long period after atrial fibrillation ablation may be     superior to the current conventional monitoring strategy used by us for determination of     atrial fibrillation recurrence (ie. return of the abnormal heart rhythm) and/or arrythmia     burden (ie. how long the abnormal rhythm continues or how often the rhythm occurs). Some data     suggests that continuous monitoring over longer periods may be better in identifying     recurrence of atrial fibrillation after ablation and thus assist in its overall management.     The device being used for this study is the Reveal XT, which, is currently FDA approved for     monitoring all varieties of cardiac rhythm disorders including atrial fibrillation.   "
253984|NCT01176656|"     The purpose of this study is to assess the burden of hypoglycemia and identify unmet need     related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on     OADs and/or insulin. This is an observational study which will identify patients with T2DM in     an administrative claims database and will link claims data with results of patient and     physician surveys concerning hypoglycemia.   "
253985|NCT01176669|"     The hypothesis of this clinical research study is to discover if the study drug apatinib can     shrink or slow the growth of pretreated metastatic triple-negative breast cancer.   "
253998|NCT03268070|"     The goal of the study is to determine the effect of repetitive transcranial magnetic     stimulation (rTMS) over the premotor cortex on training-related improvements in motor     performance and associated neural plasticity.   "
253999|NCT03267849|"     This is a study of the compliance of the lamina cribrosa with change in eye pressure.   "
254001|NCT03267862|"     The study evaluated changes in the depth of the lamina cribrosa at different eye pressures.   "
254002|NCT03267875|"     IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of     recently discovered medical conditions.      The properties that bind them are: lesions similar to tumors in the mixed organs,     lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and     often, but not always, a high level of IgG4 in the serum.      This disease has been on the rise for the past two decades and since its recognition in 2001     there has been impressive progress in understanding its various manifestations, so that today     almost every body system can be involved.      One of the conditions associated with this disease is oritis / periortitis and aneurysms   "
254003|NCT03267888|"     This pilot clinical trial studies the side effects of pembrolizumab and radiation therapy in     treating patients with stage I-III multiple myeloma that has come back after a period of     improvement or that does not respond to treatment. Monoclonal antibodies, such as     pembrolizumab, may block cancer growth in different ways by targeting certain cells.     Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving     pembrolizumab and radiation therapy may work better in treating patients with stage I-III     multiple myeloma.   "
254004|NCT03267992|"     The purpose of undertaking CLN0020.p, which is a Substudy of the European Coil registry     (CLN0014), is to investigate the use of COPD Co-Pilot AIRTM, a COPD disease management     program manufactured and operated by HGE Health Care Solutions, LLC, in subjects undergoing     the PneumRx Endobronchial Coil Treatment in a post market setting.   "
254005|NCT03268005|"     The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new     medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting     insulin aspart will be tested to see how well it works and if it is safe. Participants will     get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is     decided by chance. Both medicines will be taken together with insulin degludec. Participants     will need to take 1 injection 4 times every day (all insulins will be provided in pens). The     study will last for about 8 months (34 weeks).   "
254008|NCT03269266|"     Fever is one of most common presenting complaints in clinics in tropical countries.     Rickettsial infections, enteric fever and leptospirosis are common and important causes of     undifferentiated fever in Southeast Asia. Scrub typhus is caused by Orientia tsutsugamushi     and humans are typically infected by a bite of an infected chigger (trombiculid mite larva).     Clinical diagnosis is unreliable for identifying scrub typhus, unless a tick eschar is     present which is almost pathognomonic for the disease in Southeast Asia. A combination of     culture, paired serology and PCR has been proposed as the gold-standard method for detection.     As a result laboratory confirmation is not widely available and the diagnosis is missed     frequently in clinical practice. Some progress has been made in developing such a test and     one promising candidate is the Scrub Typhus Detect IgM Rapid Test (InBios International Inc).     We plan to use to this test in this study to estimate the prevalence of scrub typhus in     selected febrile patients presenting to clinics in Myanmar.      Patients will be followed up for one week to check for resolution of symptoms.   "
254009|NCT03269253|"     This study focused on investigating the effects of maternal disordered eating on maternal and     child outcomes as part of a secondary data analysis of the Avon Longitudinal Study of Parents     and Children (ALSPAC).   "
254022|NCT03268291|"     The trial was designed in such a way as to show that the proposed program Trust increases     the proportion of patients who adhere to therapy in the cohort of those with coronary heart     disease for two years after successful revascularization by using thrombolytic or stenting of     the coronary arteries against the background of myocardial infarction.   "
254035|NCT03268499|"     The aim of the study was to evaluate the safety and efficacy of using the new formulation     (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the     conventional formulation (Lipiodol-cisplatin emulsion). This is a prospective,     parallel-group, open-label randomized, phase II study that is conducted in accordance to the     Declaration of Helsinki and international standards of Good Clinical Practice, and approved     by the institutional review board. Eligible patients were randomized into either a treatment     arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a     1:1 ratio.   "
254064|NCT03266432|"     Evaluation of the use of thromboelastometry for early identification of the underlying     coagulopathy and to guide individualized transfusion therapy to prevent DIC development     during ICU stay after cesarean section in women with placenta previa who require a massive     blood transfusion.   "
254012|NCT03268109|"     Despite combined antiretroviral therapy (cART), milder forms of HIV-associated neurocognitive     disorders (HAND) persist in 20-50% of persons living with HIV (PLHIV). Since more PLH are at     risk for HAND due to aging, the frequency of HAND in PLHIV ≥ 65 years old is important to     quantify for planning early intervention to attenuate both functional and occupational     disabilities due to cognitive impairment.   "
254013|NCT03268148|"     Neonates undergo several painful procedures and these pain experiences can alter clinical     outcome and behavior. We aim to investigate the analgesic effect of low level laser for     procedural pain during heel lancing of term neonates.   "
254345|NCT03109730|"     The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on     ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of     ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.   "
254015|NCT03268161|"     Anti-MAG (Myelin Associated Glycoprotein) neuropathy is related to clonal B lymphocyte     proliferation producing an monoclonal immunoglobulin (IgM) with anti-MAG activity. IgM may be     a reflection of malignant lymphoproliferative syndrome (Waldenström disease) or, more often,     monoclonal gammopathy of unknown significance.      The anti-MAG antibody has a direct toxicity on the myelin sheath of the peripheral nervous     system responsible for a length-dependent demyelinating polyneuropathy. Clinically, this     results in a sensitive, ataxic predominant polyneuropathy in the lower limbs, sometimes     associated with a tremor of attitude and action tremor of the upper limbs.      Clonal B cells at the origin of IgM production may have acquired mutations affecting MYD88     (MYD88 L265P mutation) and CXCR4 (Whim-like CXCR4 mutation). The prevalence of the MYD88     L265P mutation is estimated to be 50% in monoclonal gammopathies of undetermined significance     and more than 80% in Waldenström disease. CXCR4 Whim-like mutations are found in 40% of     patients with Waldenström's disease.      No studies have reported the prevalence of these mutations in patients with anti-MAG     neuropathies.   "
254017|NCT03267706|"     The purpose of this study is to pilot the introduction of a newly developed palliative care     tool to clinicians in a family health team. The intent of the tool is to improve the quality     and comprehensiveness of palliative care, which effects caregiver and patient satisfaction     with care received, as well as clinician satisfaction with their delivery of care. Tool     effectiveness will be evaluated by measuring satisfaction scores of caregivers, patients and     clinicians who receive training and access to the tool compared to caregivers, patients and     clinicians providing usual care (without the tool). Uptake of the tool and user feedback will     be collected   "
254019|NCT03268200|"     The aim of this study was to determine whether segmental re-examination of the each segment     (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate     (ADR) and to evaluate the time-effectiveness of this approach.   "
254020|NCT03267576|"     The main purpose of this study is to assess the effects of 4 weeks each of daily treatment     with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to     metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV),     expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.   "
254021|NCT03267524|"     This pilot clinical trial studies how well Walking for Recovery from Surgery works in     improving quality of life in older adults with lung or gastrointestinal cancer and their     family caregivers. A walking program, such as Walking for Recovery from Surgery may help     support overall well-being as a caregiver, and may help improve family member or friend's     recovery from surgery.   "
254024|NCT03267485|"     The aim of the present study is to detect the expression of TET 1 gene in patients with acute     leukemia and its correlation with clinical and pathological criteria of the patients.   "
254025|NCT03267472|"     the pattern of genitourinary fistula in upper egypt   "
254026|NCT03268330|"     Migration Inhibitory Factor has proliferative and antiapoptotic actions on fibroblasts which     may be relevant to scleroderma because of the central role of a dysregulated     fibroproliferative response in disease-affected tissues   "
254028|NCT03268421|"     This study evaluates whether Fibromyalgia Integrative Training program for Teens (FIT Teens),     a combined cognitive behavioral therapy and neuromuscular exercise training program is more     effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to     cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone.     One third of participants will receive the FIT Teens training; one third will receive CBT     training; and one third of participants will receive the GAE training.   "
254029|NCT03267446|"     The aim of this study is to assess the value of adding 3D power Doppler (as a diagnostic     technique) to gray scale technique in the antenatal diagnosis of morbidly adherent placenta     as well as predict the surgical outcome regarding the type of surgery and the intra operative     morbidities.   "
254030|NCT03267394|"     This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary     Aspergillosis.   "
254032|NCT03268902|"     This study aims to assess growth and cognitive effects of treatment with azithromycin and     nitazoxanide and/or nicotinamide (vitamin B3) supplementation nicotinamide.   "
254039|NCT03269539|"     Our main approach in this research is to collect MR data using both a Routine and Fast     brain protocol on the 3 Tesla Siemens Skyra scanner using a 20-Channel Head/Neck Coil to     determine if the Fast protocol can collect data in less time without compromising patient     care.   "
254040|NCT03269552|"     This phase II trial studies how well carfilzomib with or without rituximab work in treating     patients with Waldenstrom macroglobulinemia or marginal zone lymphoma that is previously     untreated, has come back, or does not respond to treatment. Carfilzomib may stop the growth     of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and     spread. Giving carfilzomib alone when disease is responding or with rituximab when disease is     not responding may work better in treating patients with Waldenstrom macroglobulinemia or     marginal zone lymphoma.   "
254041|NCT03268668|"     The recent validation of thrombectomy in addition to thrombolysis with intravenous     administration of alteplase suggests a major revolution in the management of acute strokes.     This treatment option also opens up a new field of research, making possible the analysis of     the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the     thrombectomy procedure makes it possible to retrieve either partially or completely the clot.     Previous studies have analyzed the correlation between the composition of the thrombus and     the etiology of stroke. Their discordant results do not yet make it possible to distinguish a     particular profile of thrombus according to etiology. Other studies have shown a correlation     between the proportion of red blood cells in a thrombus and the likelihood that it is visible     in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between     the presence of lymphocytes in the thrombus and an atheromatous etiology.      The main limitations of these studies are the small number of patients included, the high     variability of conservation protocols and the absence of plasma data, which does not allow     for research on the correlation between clot composition and plasma biomarkers.   "
254347|NCT03133312|"     Primary Hypothesis: chlorhexidine gluconate antiseptic vaginal preparation is superior to     povidone-iodine vaginal preparation in decreasing the bacterial load within the vagina when     prepping prior to a cesarean section.   "
254042|NCT03268694|"     Purpose: To investigate the electrophysiological correlates of human cognition and affective     processing. Participants: Drug-resistant epilepsy patients undergoing epilepsy surgery     cortical mapping with continuous electrocorticography (ECoG) with intracranial electrodes.     Procedures (methods): Participants will perform computer-based cognitive and affective     processing tasks during routine long-term monitoring. Intracranial EEG will be collected     during the task   "
254044|NCT03267836|"     Currently, there is no standard radiation therapy (RT) dosing regimen for re-irradiation of     recurrent brain tumors, and the optimal RT fractionation to combine with immunotherapy has     not been definitively established. Hypofractionated RT in 3-5 fractions is currently favored     as the preferred fractionation to combine with immunotherapy in most clinical trials.     Multiple clinical studies have demonstrated that the combination of extra-cranial or     intra-cranial RT with PD-1 inhibitor is well-tolerated and have not shown any significant     overlapping toxicity.      Given the primary purpose of re-irradiation in the proposed study is to stimulate immune     response rather than to ablate the recurrent meningioma and that many recurrent meningiomas     may be larger than 3.5 cm, the present study will use a lower dose of hypofractionated RT of     4 CGE (cobalt gray equivalent) x 5 fractions (EQD2 ~ 28 Gy, assuming α/β of 3 for brain     tissue and RBE of 1.1 for proton therapy), which should provide optimal balance of     feasibility/generalizability and potential synergy with PD-1 blockade. Although preclinical     data suggest the combination of ionizing radiation and PD-1 blockade increases tumor     immunogenicity, this has not been confirmed in patients. This study is designed to provide     proof of concept to demonstrate on-target effect of the combination to increase     immunogenicity and to evaluate preliminary clinical efficacy.   "
254045|NCT03267017|"     This prospective study is designed to assess and quantify the correlation between respiratory     changes in R-R interval and the respiratory changed in invasive systolic blood pressure in     ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and     following a fluid bolus   "
254047|NCT03268785|"     During surgery, a fine needle puncture was proceeded when suspicious nodes was found by     clinician. Repeat the punction for 2-3 times from different orientation and then, Diff-quik     staining or PTH immunochromatographic assay were proceeded for lymph node or parathyroid     glands identification. Post-operative pathology outcome was considered as golden standard.   "
254048|NCT03267563|"     Postpartum depression (PPD) is common and can have lasting consequences for mother and child.     ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal     settings. ROSE has been found to significantly reduce cases of PPD in multiple randomized     trials in community prenatal settings with racially and ethnically diverse low-income     pregnant women. Requests for ROSE training and recent policy changes supporting payment for     comprehensive perinatal services to underserved populations suggest a context ripe for     embedding ROSE in prenatal clinics long-term. Given the need for return on investment studies     about sustainment efforts, we propose a Sequential Multiple Assignment Randomized (SMART)     Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of     ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance     in 6 U.S. states. In Year 1, all clinics will receive enhanced implementation as usual (EIAU;     initial training + tools for sustainment). At the first time at which a clinic is determined     to be at risk for failure to sustain (i.e., at 3, 6, 9, 12, 15 months), that clinic will be     randomized to receive either: (1) no additional implementation support (i.e., EIAU only), or     (2) low-intensity coaching and feedback (LICF). If clinics receiving LICF are still found to     be at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only,     or (2) high-intensity coaching and feedback (HICF). Additional study follow-up interviews     will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18     months. Outcomes include: 1. Sustainment of core program elements at each time point and     total length of time ROSE services were provided and were provided with at least moderate     fidelity. 2. Health impact (PPD rates over time at each clinic) and reach. 3. ROI (costs,     cost-offsets, and cost-effectiveness) of each sustainment step. Hypothesized mechanisms     include sustainment of clinical and organizational capacity to deliver core elements, and     engagement/ownership. The study will also examine predictors, tailoring variables, and     implementation processes to determine which kinds of clinics need which level of sustainment     support and when. To our knowledge, this study will be the first randomized trial evaluating     the ROI of a stepped approach to sustainment, a critical unanswered question in     implementation science.   "
254050|NCT03269045|"     An Open-label, Single-arm, Phase 2 Study of Biotin in Patients With Biotinidase Deficiency.   "
254060|NCT03268980|"     -  Tobacco is the leading risk factor for avoidable mortality in France and around the          world. It is also the second cause of life with disability in the world and the leading          preventable risk factor for cancer in France and worldwide.        -  The Health Barometer studies carried out for 25 years in France by Santé-Publique          France assessed prevalence of smoking in the lay population. These studies showed that          smoking prevalence has stabilized among 15-75 year olds (34.1% of current smokers) with          a slight decrease in regular smoking (from 29.1% in 2010 to 28.2% in 2014).        -  Data on the prevalence of smoking among hospital staff are contradictory. Some studies          find a higher prevalence of active smoking than the general population; others have a          lower prevalence. However, it appears that an active prevention policy with hospital          staff can significantly and rapidly reduce the prevalence of active smoking.        -  The prevalence of active smoking in patients is logically higher than in the general          population (at comparable age).        -  The data on the prevalence of smoking among medical students are also contradictory.          Yet, this population is a special interest group given their future investment in          patient care.        -  Cannabis use also appears to be an independent risk factor for respiratory diseases and          broncho-pulmonary cancers. Cannabis use among health students is not uncommon (11.5% of          students). To our knowledge, the measurement of the prevalence of Cannabis use in an          all-patient population of a hospital-university facility has never been achieved.        -  According to the health barometer 2014, about a quarter of 15-75 year olds have already          tried electronic cigarettes and 6% are regular current users. Although the toxicity of          the electronic cigarette and its interest in weaning remain controversial, its use to          patients, staff or patients has been reported very little.      The aim of this study is to assess the impact of collective and individual tobacco control     measures by measuring the prevalence of smoking on a given day at the Hospices Civils de     Lyon, among patients, staff and students present on a given day initially and 5 years later.   "
254054|NCT03265860|"     Ischemic strokes are the first cause of handicap in adult people, the second cause of     dementia and the third cause of death in France. Brain Magnetic Resonance (MR) initial     assessment is mandatory to get the right diagnosis, to exclude hemorrhagic lesions and to     determine the best treatment.      The conventional diffusion weighted imaging sequence is used to establish the diagnosis and     to estimate the volume of ischemic lesions. The perfusion weighted imaging sequences are also     used to assess the diffusion-perfusion mismatch which is supposed to be the ischemic penumbra     corresponding to territories that could be saved with appropriate treatments.      IntraVoxel Incoherent Motion (IVIM) is a multi-b diffusion sequence which allows to extract     four quantitative variables (D, D*, f, ADC) related to the true molecular diffusion and     correlated to the microvascular perfusion.      It's a quick sequence with no need of contrast injection and allowing a perfect     coregistration with the true diffusion. It has been validated in many pathologies but not in     acute strokes.      The feasibility of this sequence in acute ischemic strokes has already been assessed with     interesting results.      The study aims to assess the correlation between the quantitative values of IVIM at initial     MR exam and the modified Rankin Scale (mRS) score 3 months after an acute ischemic stroke.   "
254350|NCT03266575|"     The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The     exercise that will be performed in this study will include either pulmonary rehabilitation or     a formal home based video strengthening program   "
254055|NCT03268837|"     Local anesthetics are often given in a continuous fashion to block specific nerves after an     operation for pain control. A new infusion strategy named the 'programmed intermittent bolus'     (PIB) technique delivers the hourly dose within minutes compared to the traditional infusion     that delivers such dose over an hour. The PIB technique has demonstrated superior patient     satisfaction and reduced local anesthetic consumption when utilized for pain control during     labour and delivery. However, it is not known if the PIB technique gives any benefits during     a continuous nerve block in other settings. The aim of this randomized controlled trial (RCT)     is to elucidate if PIB is better than (traditional) continuous infusion for postoperative     analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with     respect to pain control.   "
254057|NCT03266913|"     Neonatal Jaundice occurs in 60% of term infants and 80% of premature infants. Although it is     transient, it is associated with high rate of readmission of patients in the first week of     infancy. Neonatal jaundice can cause neurological complications and kernicterus. Considering     the fact that there have been a lot of studies on probiotic role in management of necrotizing     enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this     study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in     infants hospitalized in children hospital in Bandar Abbas.   "
254061|NCT03266471|"     Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and     ulcerative colitis (UC), affects more than 1.6 million people in the United States alone.     Though the precise mechanisms underlying the inflammation and immune responses in IBD are     still being investigated, various inflammatory mediators, including pro-inflammatory     cytokines, and genes have been implicated in the disease process. At present, there are no     reliable mechanisms to predict response to individual IBD medications. The investigators seek     to evaluate whether inflammatory cytokines change longitudinally during treatment with     anti-cytokine agents in both treatment primary responders and primary non-responders. In     addition, the investigators will be evaluating the pharmacogenetics of treatment response to     these agents.   "
254062|NCT03266367|"     The aim of this work is to assess the clinical significance of serum levels of neutrophil     gelatinase-associated lipocalin (NGAL) to predict AKI in patients exposed to PCI.   "
254067|NCT03267693|"     Detection of gastrointestinal complications in mechanically ventilated critically ill     patients and its relation to oropharyngeal and respiratory infections in relation to     oropharyngeal and gastric PH.   "
254068|NCT03265769|"     Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly     performed using bilateral transfemoral access and 8 French guiding catheters. However,     transfemoral approach (TFA) is associated with higher risk of vascular access complications.5     It has been reported that using transradial approach (TRA) reduces vascular complications and     may be associated with a better clinical outcome. Transradial access is also used in complex     PCI interventions.There is a growing body of evidence regarding the use of this approach also     in CTO procedures. In available literature, all studies comparing TRA vs. TFA in CTO     consisted of single center and single operator experience. Besides, none of them is     randomized. To fill in the gap, we sought to examine the technique and outcomes of     transradial vs. transfemoral CTO PCI in a contemporary multicenter randomized study.   "
254069|NCT03267797|"     Infertility and miscarriage ordinary events in reproductive failure in humans, as are     affected one couple in every six couples of reproductive age and abortion is including in     approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted     Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains     below 30% and Recurrent Implantation Failure in one of the most important limiting factor is     the assisted reproductive techniques. According to studies conducted in recent years one of     the most important mechanisms of implantation failure is maternal immune system because the     fetus as an allograft toxic (Semi allograft) to the mother. Studies have demonstrated that     ratio of Th1 to Th2 cells increase in maternal peripheral blood cells can be directly     associated with implantation failure. Lymphocytes during implantation, in association with     endometrium and blastocyst, participate in the production of cytokines, in particular Th1     pre-inflammatory cytokines. TNFα, IFNγ ،LIF ،IL12 ،IL15 Among these are pre-inflammatory     cytokines that appear to be necessary in the early stages of implantation. The initial     inflammatory response should therefore be selectively reduced to preserve pregnancy.     Inflammatory response impairment at the beginning of pregnancy causes fetal implantation     failure, while high inflammation leads to acute rejection (spontaneous abortion) or chronic     (pre-eclampsia) ). Preserving pregnancy requires a specific cytokine pattern, in particular     Th2 cytokines (IL3, IL4, IL5, IL10, IL13, GMCSF), which causes the anti-inflammatory state of     pregnancy required. Therefore, maternal immunity seems to be involved in creating and     sustaining pregnancy through the Th1 / Th2 Thalassic Balance. An imbalance between the two     systems can be an explanation for the implantation failure in some patients. The effect of     intra-uterine lymphocyte therapy on the fertility rate of women with RIF in the mouse model     has been shown to be controlled by the Th1 system. While the Th2 system has a protective     role, two thirds of patients have had an incomplete endometrial admission. Since the immune     cells of the uterus are balanced through a broad cytokine pattern, it is important to     evaluate the implantation success of RIF patients after intrauterine insemination (IUI) of     their own lymphocytes in the uterus in the pre-implantation phase. Laboratory tests on mice     show an increase in the number of embryonic implantations with human PMBCs. Considering the     importance of TH1 and TH2 cells in the success or failure of pregnancy and the relationship     between the function and balance of these cells with pregnancy problems, such as implantation     failure (RIF), and the role of factors and inflammatory cytokines in creating proper nesting     conditions, by introducing the lymphocytes of a participants infected with RIF into the     uterus in order to induce primary inflammation, the investigators will examine its effect on     fertility and the success of implantation in women with RIF.   "
254070|NCT03265795|"     Surgical ablation of large maxillary cysts usually results in considerable hard and soft     tissue deficits that ultimately affect the final esthetic and functional outcomes.     Reconstruction of such defects; whether primarily or secondarily; offers much better     long-term outcomes. However, primary bony reconstruction becomes potentially complicated in     many cases of such large cysts encroaching or involving the maxillary sinus where a     communication with the maxillary sinus lining may be unavoidable.      Reconstruction of such defects can be accomplished using either vascularized or; more     commonly; non-vascularized autogenous bone grafts. Different bone substitutes remain to be     another viable option. The simultaneous use of titanium meshes provides physical     three-dimensional support for the bone graft contained within as well as the overlying soft     tissues. However, the drawbacks of titanium meshes in such defects remain to be mainly the     difficulty in adequately shaping the mesh and the lack of proper isolation of the mesh     contents from the maxillary sinus cavity.   "
254084|NCT03265613|"     The purpose of this study is to evaluate the efficacy and safety of Adipose Derived     Mesenchymal Stem Cells (AD-MSCs) with moderate to severe psoriasis. Any adverse events     related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of     PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI     before and after AD-MSCs infusion.   "
254390|NCT03065023|"     This is a Phase I/II multicenter, first-in-human open-label, dose escalation study to     evaluate the safety, tolerability, and anti-tumor activity of intratumoral/intralesional     injections of RGT100-PEI in subjects with selected advanced or recurrent tumors.   "
254072|NCT03266952|"     Enrollment of a population-based, prospective cohort of 3298 stroke-free adults was completed     in 2001 and annual follow-up has continued since then. This collaborative study is the first     prospective cohort study among whites, blacks and Caribbean Hispanics living in the same     community. This grant supports continued follow-up and outcome detection and expansion of     data collection in this cohort. The aims are to evaluate the relationship between vascular     outcomes (stroke, myocardial infarction (MI), and vascular death) and insulin resistance,     carotid intima-media thickness, carotid distensibility, and quantitative magnetic resonance     imaging (MRI) measures of vascular subclinical brain disease and to determine if MRI     subclinical disease accounts for race/ethnic differences in cognitive impairment. To     accomplish these aims further data collection using the population-based, prospective cohort     study is proposed. Stored baseline serum will be used to measure fasting insulin levels to     evaluate insulin resistance. High-resolution carotid imaging data will be collected at     subsequent visits to expand the measurements of subclinical carotid disease to 1300 subjects.     MRIs and a neuropsychological battery emphasizing frontal executive domains will be done on     1300 subjects and quantitative analyses performed to measure white matter hyperintensities,     silent infarcts, and silent cerebral microbleeds.      Starting in 2005, subjects enrolled in the MRI substudy began to have echocardiograms and     24hour ambulatory blood pressure monitoring. Subjects will be followed by annual telephone     interviews to ascertain stroke, MI, death, and changes in cognitive state. In-person     assessment will be done for all subjects who screen positive. Community stroke surveillance     will be maintained to insure stroke detection among the cohort. Specific diagnostic     committees classify stroke, MI and vascular death.   "
254073|NCT03265626|"     Violence against women is a well understood devastating global pandemic, and human right     violation. One in three women experienced intimate partner violence worldwide. In Ethiopia,     the level of domestic violence against women is one of the highest in the world. However,     Ethiopia is signatory for various conventions and incorporate into the constitution and other     legal frameworks. Nevertheless, effective implementation of the existing policy documents,     and engaging different stakeholders is very limited. There is paucity of evidence on piloting     the feasibility of implementing community based preventive intervention programs. Therefore,     the main aim of this study is to pilot feasibility and implement existing research evidence     and policy documents at community level to prevent domestic violence against women in Awi     zone, northwestern Ethiopia This study will be conducted in three districts of the Awi zone,     Amhara regional state, Northwestern Ethiopia.      General Objective:The overall aim of this study is to assess the outcome of community based     interventions implementation to prevent domestic violence against women, enhance community     response and determinants among women (15-49 years) in Awi Zone, Northwestern Ethiopia from     November, 2017 to November, 2018.      Specific Objectives        1. To assess the baseline level of domestic violence against women in the study area        2. To identify associated factors of domestic violence against women        3. To design intervention implementation strategy to tackle domestic violence against women        4. To implement culturally appropriate/acceptable interventions to address bottlenecks and          domestic violence against women        5. To assess the outcome of community based intervention on domestic violence against women      Research questions        -  How can prevent domestic violence against women through community based intervention?        -  What are the bottlenecks of prevention intervention implementation at community level?        -  How can implementers engage stakeholders to mobilize community and resource to implement          existing evidence based interventions to transform gender norm?      Research Hypothesis        -  Null hypothesis (Ho): this community based prevention intervention will not have effect          (difference) on the level of domestic violence against women as compared with control          (standard program).        -  Alternative Hypothesis (HA): community based prevention intervention will have a better          effect to make an improvement on the level of domestic violence against women than          control (standard services).   "
254074|NCT03267199|"     -  The relationship between admission MPV, PDW, platelet function test and ST-segment          resolution in STEMI patients treated with either thrombolytic therapy or primary          percutaneous coronary intervention        -  The relationship between admission MPV, PDW, platelet function test and high thrombus          burden & post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow of infarct related          artery in STEMI patients treated with primary percutaneous coronary intervention   "
254076|NCT03268343|"     This will be an open-label, randomised, 2-period, single-dose crossover study to determine     the comparative bioavailability of cytisine following single-dose administration in healthy     male and female subjects under fed and fasted conditions.      The study will be comprised of a pre-study screen, followed by 2 treatment periods (1 and 2)     and a post-study follow-up.   "
254077|NCT03265678|"     The aim of this study is to identify genetic patterns in normal ageing skin in order to     better understand age-related changes.      Data has suggested that skin ageing has a genetic basis and past studies have identified     genes that promote skin aging due to sun exposure.   "
254078|NCT03266809|"     This study will investigate the influence of systemic adjuvant/neoadjuvant therapy (SAT:     chemotherapy +/- anti-HER2 antibodies (trastuzumab +/- pertuzumab) on heart function/rhythm     and cardio-respiratory fitness in recently diagnosed breast cancer patients. In some     patients, SAT damages the heart (so-called 'cardiotoxicity') and this can have a serious     impact on the patient's quality of life and overall survival. It has also been suggested that     anticancer therapies may lead to repolarization abnormalities, QT prolongation and autonomic     dysfunction, clinically reflected by an increase in HR and a reduction in heart rate     variability (HRV). There is a lack of information in the literature regarding the extent and     time-course of changes in cardiac function, cardiac rhythm and cardio-respiratory performance     ('fitness') in these patients. Moreover, the differential influences of specific treatment     regimes (e.g. SAT or SAT plus radiotherapy) and different chemotherapy drugs on     cardio-respiratory performance remain unclear. A better understanding of these issues is the     primary aim of this study.   "
254079|NCT03266250|"     Study Protocol: Outcome Measurements Primary Outcome The main outcome will be the     preoperative performance of the dIVCmax/IVCCI ratio to foresee the incidence of hypotension     after spinal anesthesia in a greater extent to that of the established IVCCI measurements.      Secondary Outcomes To identify other echocardiographic or clinical measurements that can     predict an intraoperative spinal-induced haemodynamic instability.      Sample Size Calculation A pilot study of 20 patients revealed a detected area under the ROC     curve (AUC) of 0,91 for dIVCmax/IVCCI and for dIVCmax 0,82 with rank correlation between the     two assays being 0.87 in both positive and negative cases. Based on this result, a sample of     56 patients will achieve 80% power to detect significant difference (at a level 0.05) between     dIVCmax/IVCCI and dIVCmax.      Potential Benefits of the Study The results of this study will allow us to determine which     clinical or US-measurement can yield better performance so as a preoperative prediction of     spinal-induced hypotension can be achieved; that way these measurements can permit and guide     a targeted preoperative fluid challenges prior to the implementation of spinal anesthesia     Potential Side Effects of the Study Participation in this protocol will not put patients at     higher risk for complications since we do not perform any intervention (either     pharmacological or surgical) There will be no occupational risks to researchers or     assistants. Proposed Timetable According to the exclusion criteria and taking into account     the number of cases performed in our department per monthly basis, it should take us     approximately 6 months to recruit 60 patients.   "
254083|NCT03266458|"     all patient presented with ST elevated myocardial infarction and underwent PPCI will be     calculated with CHA2DS2-VASC score and contrast volume / creatinine clearance as apredictive     value for Contrast induced nephropathy and the predictive value of these scores will be     compared with the approved predictive value of MEHRAN score which is also will be calculated     to every patient .   "
254175|NCT03268811|"     The purpose of this study is to evaluate long-term safety and efficacy of teduglutide     treatment in Japanese children with Short Bowel Syndrome (SBS) who have already completed the     SHP633-302 study.   "
254086|NCT03266627|"     Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the     Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in     children, adolescents and young adults with refractory ADV infection post Allogeneic     Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).   "
254087|NCT03268317|"     Neuropsychiatric adverse effects of direct acting antiviral drugs, especially Sofosbuvir and     Daclatasvir combination therapy (with or without ribavirin) in patients with chronic     hepatitis C , genotype four (the predominant genotype in Egypt).   "
254088|NCT03267667|"     Correlation of severity of obstructive sleep apnea and function of the right ventricle by     means of 2D echocardiography and cardiac MRI   "
254089|NCT03265353|"     The purpose of this study is to determine if dietary potassium can attenuate the deleterious     effects of high sodium on blood vessel function in healthy, salt-resistant participants.   "
254090|NCT03268655|"     Estimate the impact of a 6‐week intake of twice daily of 1000 mg of ginger extract on the     composition of the gut microbiome using a pre‐post test design, i.e. examine the change of     microbiome over time within the subjects.   "
254092|NCT03267979|"     Different pain assessment methods have been proposed to evaluate analgesic efficacy after     surgical operation. Pain is a subjective phenomenon. Patient did his pain self assessment.     But, cooperation of the patient is limited by cultural differences, language barriers or     residual effect of products used while general anesthesia.      A lot of study were conducted to demonstrate and to quantify the pain after an operation. The     aim will be dose analgesic treatment better without cooperation of the patient.      This sudy concerns patients on the post anesthesia care units one hour after their arrival.     They will have electrocardiogram and video-pupillometer.   "
254093|NCT03268759|"     Reward processing will be examined in prenatally exposed emerging adults in a longitudinal     design. Participants will be followed for one year to see if neural markers of reward     processing prospectively predict risk-taking behavior.   "
254095|NCT03265366|"     The aim of the study is to compare the concordance between chest computerized tomography-scan     (CTscan) and Magnetic resonance Imaging (MRI) for the description of the abnormalities seen     in Allergic BronchoPulmonary Aspergillosis (ABPA).   "
254097|NCT03266978|"     ST-elevation myocardial infarction is a major cause of morbidity and mortality worldwide.     ST-elevation myocardial infarction damages the regional myocardium that undergoes ischemia     and necrosis, resulting in impairment of both systolic and diastolic functions of the heart.     Left ventricular function and myocardial infarct size both serve as the main determinants Of     patients' outcome after myocardial infarction. Timely management of ST-elevation myocardial     infarction, using reperfusion therapy, including fibrinolysis and primary percutaneous     coronary intervention, leads to a better outcome for these patients.   "
254098|NCT03263325|"     Acute kidney injury (AKI) is common in children after cardiac surgery with a reported     incidence of 20-40%. Pediatric AKI has been found to be associated with important short and     long-term adverse outcomes.      A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is     the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies     exclusively on elevation of serum creatinine concentration and oliguria. Both of these     markers lack sensitivity and specificity, and result in delayed detection of kidney injury.      This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect     subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary     bypass.   "
254099|NCT03267823|"     The investigator is testing blood samples to compare the results of two different techniques.     Since blood loss and the need for blood transfusions continue to be major problems after     heart surgery and other types of surgery, the blood clotting levels are constantly checked     during heart surgery as part of clinical care.The purpose of this study is to compare the INR     levels in blood before and after the heart bypass during surgery.   "
254100|NCT03267056|"     The registry is a prospective, multicenter, single arm post-market real-world registry in     China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the     Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).   "
254102|NCT03267095|"     Music therapy is an established form of creative art therapy. By using music as a specific     medium of communication, expression and adapting it to the individual resources and abilities     of the patient, music therapy can be beneficial in activating and supporting mental and     psycho-physical recover .   "
254103|NCT03266874|"     The primary objective of this study is to obtain implant survivorship and clinical outcomes     data for the commercially available G7 BiSpherical Acetabular Shell.   "
254105|NCT03268798|"     Following stroke, muscle weakness and impaired motor function are expressed in both the more     (MA; paretic) and less affected (LA; non-paretic) sides. Although the efficacy of resistance     training is well recognized, training the MA limb directly may be initially difficult due to     muscular weakness. Cross-education is training one side of the body increases strength in     the untrained and opposite side. This concept can be applied in strength training when     training the more affected sides cannot be initiated. Recently, our lab found six weeks of     dorsiflexion resistance training in the LA leg improved the strength of both trained and     untrained legs of chronic stroke participants.      The current project explored if cross-education exists in the upper limb in chronic stroke     participants and if there are related changes in cortical and spinal cord plasticity. We     hypothesized that unilateral strength in the less affected arm could enhance wrist extension     strength bilaterally with related neural adoption and improved clinical function.   "
254106|NCT03267732|"     To evaluate the pharmacokinetics of single and multiple doses of AM0010 in healthy patients   "
254108|NCT03266822|"     Data on the impact of biological therapies, especially of IL6-blocker treatment, on the     T-cell phenotype in rheumatoid arthritis (RA) are limited, inconclusive, and mainly involve     short-term follow-up.      Here, the investigator prospectively measure the percentages of 15 circulating T-cell     subtypes using flow cytometry. The investigators aim to obtained transversal and longitudinal     data in 30 anti-TNF responders, 19 secondary anti-TNF-non-responders, 43     IL6R-antagonist-responders before, 8 weeks and, after, at least, 6 months of biological     therapy. These are then compared with results obtained in early, untreated RA patients and     gender-and-age matched healthy controls.   "
254109|NCT03268382|"     The purpose of this study is to make a preliminary assessment of the efficacy of a combined     APR-246 and PLD chemotherapy regimen in patients with platinum-resistant recurrent high grade     serous ovarian cancer (HGSOC) with mutated TP53. In addition, the study aims to assess the     safety profile of the combined APR-246 and PLD chemotherapy regimen, to evaluate potential     biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial     will enroll at least 25 evaluable patients.   "
254112|NCT03264144|"     This study will examine the effectiveness of a social norms campaign in correcting smoking     misperceptions, reducing smoking susceptibility and changing smoking-related behaviours in     Hong Kong adolescents.   "
254113|NCT03266744|"     This trial is a feasibility study prior to a planned phase III trial. Currently, assessing     response to treatment of metastatic breast cancer in the bone is limited by the technical     problems associated with CT scans and bone scans. WB-MRI provides theoretical and practical     advantages that allow for more detailed analysis of disease response or progression. This may     allow for earlier identification of progressive disease and earlier change in treatment.      Participants in the study will have a CT scan, bone scan and WB-MRI at baseline and then     repeated CT and WB-MRI scans every 12 weeks (until week 96, and then every 24 weeks) until     there is evidence of progressive disease on either of the imaging modalities. In addition to     the regular scans on the study, patients will be given the opportunity to participate in a     study of how reproducible the findings of WB-MRI scans are. At the point of disease     progression, a repeat bone scan is performed and the involvement of the patient in the trial     comes to an end.   "
254115|NCT03265405|"     For pulmonary sarcoidosis, the initial dose recommended by the joint statement of the     American Thoracic Society (ATS), European Respiratory Society (ERS), and The World     Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) is 20-40 mg per day.5     The exact dose and duration of treatment for sarcoidosis are unknown.4 We hypothesize that a     higher dose of 40 mg per day as compared to a 20 mg/day dose of prednisone will be more     effective in preventing post-treatment relapse by effective initial suppression of the     granulomatous inflammation and reduction of the disease load. In this study, we compare the     efficacy and safety of medium dose (40 mg/day prednisone) and low dose (20 mg/day prednisone)     glucocorticoids in the treatment of acute sarcoidosis.   "
254116|NCT03262766|"     The purpose of this research study is to investigate the effectiveness of a combinatorial     therapy of breathing low oxygen in short bursts-acute intermittent hypoxia (AIH) and upper     limb training on arm strength and function, and comparing it with individual treatments in     persons with spinal cord injuries.      The investigators hypothesize that a combinatorial intervention with AIH therapy + upper limb     training will be significantly more effective in improving hand function, compared to     individual treatments alone.      To test this hypothesis, the investigators will determine the impact of combined daily AIH     therapy and high-repetition task-specific upper extremity training on arm strength and hand     dexterity in persons with spinal cord injuries.   "
254117|NCT03268551|"     The study will examine how medical cannabis use affects opioid analgesic use over time, with     particular attention to THC/CBD content, HIV outcomes, and severe adverse events.   "
254142|NCT03260218|"     The incidence of post-operative delirium in the South-east Asian population is not known.     Through a prospective, single centre, observational study, the investigators aim to     characterize the incidence and risk factors of delirium in older adults undergoing elective     total joint arthroplasties (TJA). The study will recruit eligible patients (65 - 90 years old     undergoing elective TJA), with a targeted sample size of 500. Patients will be screened for     dementia and Confusion Assessment Method (CAM) scores obtained pre and post operatively.     Other data such as preoperative Charlson comorbidity index (CCI), post op complications using     Post operative Morbidity Survey (POMS), pain scores, readmission rates and length of hospital     stay (LOS), functional and health-related quality-of-life (HRQoL) will also be collected and     analysed.   "
254118|NCT03264846|"     Periodontal diseases are chronic inflammatory disease occurred by the interaction between     pathogenic microorganism and the host defense. Polycystic ovary syndrome (PCOS) is a     reproductive and metabolic disease associated with increased risk of cardiovascular events.     Endocan is a proteoglycan secreted mainly by endothelial cells under the control of     inflammatory cytokines.      Periodontal diseases, including gingivitis, are common chronic infectious diseases caused by     predominantly pathogenic microorganisms that colonize the subgingival area and cause local     and systemic elevations of proinflammatory cytokines such as Interleukin-6 (IL-6).      Several lines of evidence established the association between periodontal and systemic     diseases, including metabolic syndrome, diabetes, and cardiovascular disease.      Because of the fact that both periodontal disease and PCOS are associated with systemic     inflammation and insulin resistance, these two disorders may be linked through a common     pathophysiologic pathway.      A number of studies have indicated a possible relationship between PCOS and periodontal     inflammation. Despite common risk factors, including oxidative stress, the relationship     between chronic periodontitis (CP) and PCOS remains unclear.      The aims of the study were to determine serum and saliva Endocan and IL-6 levels and to     evaluate the correlation between these two biomarker in women with periodontal disease and     PCOS.   "
254119|NCT03263156|"     Sleep problems are very common in children with ADHD, with a prevalence rate as high as 73%,     and often pose significant challenges and stress to the families. Sleep problems in ADHD     children are strongly associated with the exacerbation of daytime symptoms, impaired physical     health, and poor parental mental health. The present study is a randomised controlled trial     to compare the effects of a parent-based sleep intervention for children with ADHD (aged     6-12). Eligible participants will be randomised to either intervention (two face-to-face     consultation sessions and one follow-up phone call) or waiting-list control condition.     Assessments will be conducted at pre-treatment (baseline), one-week after the intervention     (post-treatment), and 3 months after the intervention.   "
254176|NCT03269110|"     FACT 4 Child is a follow up study of mothers who participated in the Folic Acid Clinical     Trial (NCT01355159) and their children at 4-6 years of age to determine the effect of high     dose folic acid supplementation on social impairments associated with Autism Spectrum     Disorders (ASDs), and deficiencies in a range of executive function and emotional and     behavioural problems in young children, and the risk of death.   "
254120|NCT03267810|"     The purpose of this research study is to: 1) test whether transcutaneous electrical nerve     stimulation (TENS) after spinal cord injury can reduce the onset of post-injury neuropathic     pain; and 2) to learn more about this kind of pain and who is at risk for suffering from this     type of pain after spinal cord injury. Neuropathic pain is a type of pain that occurs in     about 50% of people with spinal cord injury. This type of pain is usually described as     burning or tingling, and is present around the level of injury and/or in areas below the     level of injury. The investigators' goal is to try a non-drug treatment (TENS) that may help     prevent this pain from occurring. Pain symptoms will be compared between the study     participants who receive active TENS and the study participants who receive a sham TENS     treatment.   "
254126|NCT03265223|"     Pain still remains a limiting factor in early discharge of patients undergoing laparoscopic     cholecystectomy. Almost all earlier studies done to compare the efficacy of local     anaesthetics used intraperitoneally as compared to intraincisionally used equal amounts of     drugs at the two locations, usually 10-20 ml. Using this large amount of drug in the small     space of intraincisional location as compared to similar amount of drug in large     intraperitoneal space created an inadvertent bias in favor of patients receiving the drug     intraincisionally so such patients naturally experienced less pain. The investigators decided     to standardize the drug used at these two locations as 1ml/cm and conduct a new study     comparing the effects of drugs in relieving pain when used at these two locations.   "
254128|NCT03269201|"     The diagnosis and management of movement disorders, such as Parkinson's disease (PD),     parkinson-plus syndromes (PPS), dystonia, essential tremor (ET), normal pressure     hydrocephalus (NPH) and others is challenging given the lack of objective diagnostic and     monitoring tools with high sensitivity and specificity. A cornerstone in research of     neurological disorders manifesting as MDi is the investigation of neurophysiological changes     as potential biomarkers that could help in diagnosis, monitoring disease progression and     response to therapies. Such a neuro-marker that would overcome the major disadvantages of     clinical questionnaires and rating scales (such as the Unified Parkinson's disease rating     scale -UPDRS, for PD, The Essential Tremor Rating Assessment Scale -TETRAS, for ET and     others), including low test-retest repeatability and subjective judgment of different raters,     would have real impact on disease diagnosis and choice of interventions and monitoring of     effects of novel therapeutics, including disease modifying therapies.      To address this, ElMindA has developed over the last decade a non-invasive, low-cost     technology named Brain Network Activation (BNA), which is a new imaging approach that can     detect changes in brain activity and functional connectivity. Results from proof-of concept     studies on PD patients have demonstrated that: 1) PD patients exhibited a significant     decrease in BNA scores relatively to healthy controls; 2) notable changes in functional     network activity in correlation with different dopamine-agonist doses; 3) significant     correlation between BNA score and the UPDRS). 4) BNA could also differentiate early PD from     healthy controls   "
254133|NCT03266861|"     To our knowledge, the measurement of the transcutaneous oxygen pressure during walking is the     only continuous method that estimates the importance of ischemia, bilaterally and segment of     limb by segment of limb. The determination of the lactates concentration, with micro method     from earlobe sampling, is very widely validated in physiology and exercise physiopathology;     and it is widely used, by laboratories, for exercise investigation in athletes. We use it in     routine to evaluate the presence of functional limitation during tcpO2 tests on a treadmill.      The present study hypothesises a significant relationship between lactatemia variation     (difference between lactatemia after 3 minutes of recovery from walking and the value at     rest) and tcpO2 decrease from rest of oxygen pressure (DROP) values for patients with     peripheral artery disease (PAD).   "
254135|NCT03263780|"     This prospective trial aims to determine if enhanced prostate imaging using two novel imaging     technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers     not seen on standard multiparametric prostate MRI in patients considered candidates for focal     HIFU.   "
254138|NCT03259035|"     The purpose of this study is to find out the effects of chemotherapy followed by less     invasive surgery on patients and their early rectal cancer. The approach of this trial will     be considered a success if at least 65% of participants are able to keep the rectum.   "
254139|NCT03262688|"     A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, 2     to <6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in     this study will start with the oldest age group (12 to <17 years) and will continue in a     step-wise fashion until appropriate doses are established for all 3 pediatric age groups (12     to <17 years, 6 to <12 years, 2 to <6 years).   "
254231|NCT03214848|"     This is a randomized prospective study evaluating the impact of a brief contraceptive     education intervention with optional referral for financial counseling on post abortion     long-acting reversible contraceptive (LARC) uptake and contraceptive use at three months post     abortion.   "
254143|NCT03257228|"     Diabetes mellitus is among the most common chronic diseases, with significant and well     documented impact on oral cavity health. Among the most common diseases of the oral cavity     mucosa and complications in patients with impaired glucose metabolism and diabetes mellitus     is oral lichen ruber (OLR), which according to World Health Organisation (WHO) is considered     potentially malignant disorder. It was found that lichen ruber in diabetes mellitus has a     much more aggressive clinical course in the form of atrophic-erosive and ulcerative lesions     showing an increased tendency to malignant transformation. Although OLR etiology is unknown,     evidence suggests cell-mediated autoimmune pathogenesis. OLR epithelial cells show anomalies     in both enzymatic activity and carbohydrate metabolism, which may be related to hormones     regulating carbohydrate, insulin and insulin-like growth factors 1 and 2 (IGF-1 and IGF-2)     metabolism. The hypothesis of our research is that patients with diabetes mellitus and oral     lichen ruber lesions will have a disturbance of insulin-like growth factors 1 and 2 and hence     a greater risk of malignant transformation, compared to patients with oral lichen ruber     without diabetes and healthy patients without alterations in the oral mucosa.   "
254353|NCT03110770|"     This is a multicenter, randomized, study to evaluate the safety, immunogenicity, and efficacy     of VRC-ZKADNA090-00-VP (Zika virus wildtype DNA vaccine) or placebo. In Part A, the primary     objective is to evaluate the safety and tolerability of the vaccine. In Part B, the primary     objectives are to evaluate the safety and efficacy of the vaccine compared to placebo.   "
254147|NCT03269162|"     Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing     relapse and metastasis of early postoperative NSCLC patients. Method: In this     multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with     complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with     chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group,     N=72). Peripheral blood CTCs and immune cells were detect on five different time points:     after operation、4 chemotherapy cycles were over、12 months after operation、18 months after     operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined     with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life     of postoperative patients; and decreasing the side effect of chemotherapy.   "
254151|NCT03267784|"     The aim of this clinical trial is to investigate the efficacy (by monitoring the wound     surface area reduction of Diabetic Foot Ulcers) and safety (by monitoring adverse events) of     the medicinal product to be studied after one single application on the wound surface of     patients with diabetic neuropathic ulcer.   "
254157|NCT03269136|"     To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients     with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose     and select the recommended Phase 2 dose.   "
254159|NCT03269123|"     Idiopathic blepharospasm (IB) is a rare but well characterised adult onset focal dystonia     that may cause severe visual disability. The most effective treatment is with periodic     injections of botulinum toxin into the pre-tarsal and / or pre-septal orbicularis oculi     muscles bilaterally. However, even with treatment, practical visual function often remains     compromised.      A subset of IB sufferers find that eye opening improves with focal unilateral digital     pressure usually on a specific point on the temple. The Investigators have developed a     spectacle mounted spring-loaded prosthesis (the Pressop device) to apply continuous     individually localised focal pressure on the temple to mimic the effect of finger pressure.      The Investigators recommended a trial of this simple safe device in those IB patients who     report improvement in eye opening with focal digital temple pressure.   "
254160|NCT03269227|"     This is a monocentric prospective study of radiotherapy using accelerated hypofractionation     with Tomotherapy in Malignant Pleural Mesothelioma (MPM) patients after pleurectomy /     decortication (P / D) or biopsy.      The treatment will be delivered using Tomotherapy, that allows to adopt dose accelerated     hypofraction criteria. Treatment duration is 5 consecutive days.   "
254161|NCT03268720|"     Patients with non-celiac gluten sensitivity (NCGS) complain about gastrointestinal and     extraintestinal symptoms while consuming gluten-containing cereals. The symptoms strictly     correlate with ingestion of gluten-containing cereals and disappear quickly under elimination     diets. Till now, there are no specific markers to diagnose NCGS. This study aims to determine     the effect of a low FODMAP diet (fermentable oligo-, di- and monosaccharides and polyols) and     a glutenfree diet on the mucosal immunity, clinical symptoms, and psychological well-being.     Furthermore, the influence of the diets on the microbiome will be analyzed.   "
254164|NCT03251495|"     The primary objective of this study is to evaluate the antibody response to the cholera     vaccine, Vaxchora®, in healthy subjects.      Investigators also seek to evaluate additional markers of the adaptive immune response     including plasmablasts, activated B cells, memory B cells, and T cell responses in healthy     subjects receiving cholera vaccine, produce monoclonal antibodies against cholera, and     evaluate the safety and reactogenicity in healthy subjects receiving cholera vaccine.   "
254165|NCT03267654|"     This is an open-label, multicenter, randomized, phase II clinical trial, which aims to     evaluate the effectiveness and safety of gefitinib versus combination of gefitinib and     doublet chemotherapy or apatinib in advanced non-small cell lung cancer (NSCLC) patients with     epidermal growth factor receptor (EGFR) activating mutation (exon 19 deletion or exon 21     L858R point mutation), accompanied with Bim deletion or low activating EGFR mutation     abundance.   "
254166|NCT03254160|"     This is a randomized, double-blind, placebo-controlled parallel group outpatient 42-day     treatment study that will utilize standard stroke rehabilitation outcome measures to evaluate     the effect of DNS-3379 on upper extremity motor recovery in subjects following ischemic     stroke.   "
254168|NCT03250819|"     Glaucoma is one of the most prevalent eye diseases and the second most common cause of     blindness worldwide. The most common form is primary open angle glaucoma (POAG). Glaucoma is     a slowly progressing neuropathy of the optic nerve that causes loss of visual field and     eventually blindness. Elevated intra-ocular pressure (IOP) is the most important risk factor.      Corticosteroids, which are often used for the treatment of many diseases in ophthalmology and     other specialities, may cause an elevation of the IOP. It is estimated that corticosteroids     induce ocular hypertension in approximately 18%-36% of the general population and in patients     with POAG this percentage can be as high as 92%. When the treatment is sustained, this can     cause a glaucomatous neuropathy of the optic nerve (corticosteroid-induced glaucoma).      The precise pathogenic mechanism isn't clear yet. Genetic factors are likely to affect the     susceptibility to corticosteroid response. Therefore, an overview of the genetic mechanisms     of corticosteroid-induced glaucoma can give more insight in the pathogenesis. In this study     the researchers investigate the occurrence of SNPs (single nucleotide polymorphisms) in 150     cases with a steroid-response in comparison with 300 controls exposed to corticosteroids     without a steroid-response.      Up to now, one small GWAS has been conducted comparing 32 patients with and without     corticosteroid-induced ocular hypertension after treatment with intravitreal triamcinolone.     In this study, two SNPs proximal of the transcriptional start site (near the 5') of HCG22 on     chromosome 6 were identified. However, this is a rather small sample population and the     investigators didn't match for the underlying disease. Further, in another small study,     Hogewind et al. performed SNP analysis in multiple genes (SFRS3, FKBP4, FKBP5, and NR3C1) in     corticosteroid-induced ocular hypertension.      This study enables the investigators to identify patients at risk for developing     corticosteroid-induced glaucoma and to gain a better insight in the pathogenesis. This may     also lead to the discovery of biomarkers that indicate an increased risk of developing a     steroid-induced glaucoma and new prevention and treatment strategies, which are necessary as     the treatment of corticosteroid induced-glaucoma now only focuses at lowering the IOP and can     still be challenging.   "
254172|NCT03267966|"     The study evaluates if a standardized method of pathological evaluation of the specimen     affects the R1 resection rate after Pancreatico-Duodenectomy (PD) for cancer.   "
254174|NCT03250676|"     Phase 1 of the study will be conducted to determine the maximum tolerated dose (MTD) and/or     the recommended Phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic     estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast     cancer.      Phase 2 of the study will be conducted to estimate the efficacy of H3B-6545 in terms of     response rate, duration of response (DoR), disease control rate (DCR), progression-free     survival (PFS), and overall survival (OS) in all participants and in participants with and     without the estrogen receptor alpha (ERα) mutation.   "
254178|NCT03267758|"     Researchers at MCW have discovered a new pathway that links the type of bacteria present in     the intestines to the severity of heart attacks. This discovery of a relationship between     intestinal bacteria, bacterial metabolites, and severity of heart attacks means that for the     first time, the investigators may be able to determine a person's probability of having a     heart attack via non-conventional risk factors. This may provide opportunities for novel     diagnostic tests as well as a potential for therapeutic intervention. The link between gut     microbiota and the severity of heart attacks may also lead to novel therapeutic approaches     (probiotics, non-absorbable antibiotics) to prevent heart attacks from happening. The studies     proposed will test the hypothesis that altered intestinal microbiota are mechanistically     linked to the pathogenesis of cardiovascular disease. The investigator's objective is to     determine whether inflammatory markers in the blood are decreased and endothelial cell     function improved by a probiotic in patients with established coronary artery disease.     Furthermore, the investigators wish to elucidate a mechanism by which the gut microbiota     regulates serum inflammatory markers.        1. Specific Aim 1 will determine the impact of a probiotic on circulating leptin and TMAO          levels, conventional risk factors for cardiovascular disease and diabetes (total          cholesterol, LDL cholesterol, oxidized LDL, triglycerides, C-reactive protein, serum          amyloid A, fibrinogen and adiponectin, glucose-dependent- insulinotropic polypeptide          (GIP), glucagon-like-peptide (GLP-1), glucagon, insulin), and their relationship to the          intestinal microbiota (15 representative microbial groups) as non conventional risk          factors. Several blood samples will be collected to measure biomarkers. Participants          will provide periodic stool samples in order to measure gut bacterial biodiversity.          Lastly, endothelial cell function (flow mediated dilation) will be measured in order to          assess blood vessel function.        2. Specific Aim 2 will determine the impact of a probiotic on metabolites derived from the          intestinal microbiota as candidates for non-conventional risk factors of cardiovascular          disease. The relationship between metabolites derived from the intestinal microbiota,          endothelial cell function and risk factors for cardiovascular disease identified in          Specific Aim 1 will be correlated.   "
254180|NCT03247881|"     The objectives of this study are 1) to determine if consumption of mixed nuts influences food     intake and choice, and 2) to determine how personality traits affect food choice, including     mood, stress, tendency to seek approval, tendency toward food cravings, and approach to food     intake control.   "
254181|NCT03260595|"     This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin     irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the     safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2.   "
254183|NCT03260205|"     The purpose of this study is to determine if an investigational treatment is effective in     improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old     diagnosed with ADHD.   "
254185|NCT03267745|"     This is a safety and tolerability study investigating the effect of an amino acid formulation     in healthy volunteers during and after limb immobilization.   "
254192|NCT03266796|"     Shared decision making (SDM) is increasingly recommended in health care and reduces the     unbalanced power between physical therapists and patients. There is an increased focus on     communication between physical therapists and their patients during the goal setting process     in current research. This study will focus on SDM in physical therapy goal setting.      The SDM Process includes a problem definition and different goal options. Good communication     between physical therapists and patients during the goal setting process with an explicit     agreeing on both sides regarding treatment goals and options improves patient satisfaction,     treatment adherence and health outcomes.      Patients generally prefer to be actively involved in the shared decision making process.     However, the preferred level of involvement of patients regarding decisions differs.     Therefore, physical therapist should consider about patients' preferred level of involvement     in shared decision making. Previous research observed SDM behaviours of physical therapists     only in private practice settings. Research in other settings like the rehabilitation setting     are recommended. It is unknown whether there are differences between settings in the SDM     behaviours of physical therapists during first consultation.   "
254194|NCT03253120|"     The Postural Tachycardia-Syndrome (POTS) is a form of autonomic dysregulation, typically     accompanied by symptoms of orthostatic intolerance (OI). OI is defined by the inability to     tolerate the upright position and is improved by lying down. POTS is considered a syndrome     that may include a number of several disorders. Symptoms should be persistent for at least 6     months to reach a diagnosis. It is characterized by a sustained heart rate (HR) increment of     30 beats/min or more within 10 min of standing or head-up tilt (HUT) in adults, in the     absence of orthostatic hypotension and with the presence of symptoms of OI. In children and     adolescents a diagnosis requests a HR increment of at least 40 beats/min. The increment in HR     when moving to an upright posture is often a response to a reduction in venous return,     causing excessive blood pooling in the lower limbs. The symptoms present in POTS vary     greatly. Typical symptoms are lightheadedness, dizziness, blurred vision, mental clouding     (brain fog) or cognitive dysfunction. Other symptoms may present as palpitations or chest     pain. Additional symptoms consist of postural headaches, nausea, sleep disturbances, fatigue     and gastrointestinal dysfunction. The manifestation of symptoms in POTS varies in severity,     frequency and combination, resulting in POTS being a very heterogenous and subjective     disorder. Symptoms can be severe and often make simple daily activities difficult to an     extent that compromises the patients quality of life. Typically symptoms exacerbate in the     mornings, after physical activity, after eating and during menstruation.      This study objective is to examine the occurrence, mechanisms and causes of impaired     attention in POTS as well as to test the effect of acute water ingestion for attention in     POTS. The investigators therefore conduct a study including patients with POTS and healthy     volunteers.      All participants will receive a dossier of five self-assessment questionnaires after giving     informed consent. Clinical examination includes 2 HUT-tests while standing for 15 minutes,     conventional measuring of blood pressure, continuous recording of NIRS signals during     testing, determination of pupil size, the diameter of the optic nerve and Neuropsychological     testing (Test of Attentional Performance, mobility version (TAP-M), Go/NoGo Test, Divided     Attention Test)   "
254198|NCT03238326|"     To further characterize the long-term safety and tolerability of brexpiprazole in adolescents     with schizophrenia   "
254237|NCT03212352|"     This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol)     are superior compared to using only one of these drugs (Misoprostol) as medical treatment for     a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is     ultrasonographically confirmed qualify for this study.      It is expected that the combination of Mifepristone and Misoprostol is more effective in     reaching complete evacuation, and therefore can prevent more invasive treatment such as     curettage.   "
254200|NCT03268863|"     This study is testing whether or not low-cost, virtual reality (VR) headsets for mobile     phones can be used as a potential distractor from pain and thus would have clinical     applications as a low-cost, non-pharmaceutical method to increase pain tolerance in patients     undergoing painful or uncomfortable procedures. To do this, the investigators are asking     volunteers to submerge their hand up to the wrist in cold water (Cold Pressor Test), either     while playing an interactive virtual reality game on the headset, or while wearing a VR     headset that is turned off as a control. The investigators will record the participants'     tolerance to cold water as measured by how long the participants are able to keep their hand     in the cold water.   "
254354|NCT03116971|"     M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose     of the study is to assess the Safety and Efficacy of M3814 in combination with chemotherapy     with SCLC ED.   "
254203|NCT03233633|"     Study Objectives: Primary reduction of pain and reduction in overall opioid utilization.     Secondary improvement in overall patient well being, weight stabilization with increased     appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.      Study Rationale: To determine optimum use and dosing of medical marijuana (CBD:THC) for pain     and symptom management.      Study Population: This study specifically will enroll cancer and non-cancer patients as a     primary diagnosis suffering from pain and having a terminal illness (defined as having less     than 6 months to live) requiring end of life care.   "
254205|NCT03240003|"     The present study is a double blind trial that seeks to examine the feasibility,     acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy     (GC-MRT) in individuals with social anxiety disorder (SAD)   "
254206|NCT03235492|"     (1) to determine whether the ratio of glycated albumin and total albumin in saliva is     equivalent to blood and (2) to investigate whether the non-invasive SmartAlbu portable     salivary sensor is as accurate as standard tests that measure glycosylated hemoglobin     (HbA1c).   "
254208|NCT03231813|"     Irritant contact dermatitis induced by sodium lauryl sulphate (SLS) is often used as a model     for testing efficacy of various topical preparations. Aforementioned model is standardized     and described in guidelines, but it is not explicitly stated where the irritation should be     induced. Published clinical trials usually irritate volar aspect of forearms or upper back.     Also, lower back and dorsal aspect of forearm are sometimes used.      Skin parameters vary depending on anatomic location of measured skin. There is a difference     in stratum corneum thickness, hydration and transepidermal water loss across different     locations, including between volar forearm and upper back.      Furthermore, regional difference in skin response to irritation by tape stripping and     benzalkonium chloride were observed. Such differences are also possible in SLS irritation     model. One study has shown higher, but not statistically significant, response of back in     comparison to forearms, but it had a very small sample size (n=9).      Moreover, there are regional variations of topical preparations absorption. Hydrocortisone     had 1,7 times higher absorption when applied to upper back in comparison to forearms. Those     variations could be explained by different corneocyte size and number of their layers between     back and hands.      Skin baseline properties and response to irritation seem to be dependent on anatomic     position. Those differences could mean different response to treatment. Since published     trials only tested efficacy of various preparations on one anatomic location, it is possible     their results would be different if tested on other body parts. It could limit validity and     usefulness of conducted trials. The aim of this study is to determine if there are regional     differences of skin response to irritation and emollient cream treatment in irritant contact     dermatitis model.   "
254210|NCT03230773|"     Survival from out-of-hospital cardiac arrest is time critical and diminishes rapidly without     appropriate intervention. Bystander CPR at least doubles the chances of survival and the     additional use of a public access defibrillator (PAD) can again double overall survival     rates. PADs are designed to be easy and simple to use, but whether untrained bystanders can     use them safely and effectively is unknown. This study will aim to assess the ability of     untrained bystanders to deploy a PAD in a simulated cardiac arrest.   "
254234|NCT03224871|"     The advent of checkpoint blockade immunotherapy has revolutionized the management of     metastatic non-small cell lung cancer (NSCLC). Despite the promising evidence for deep and     durable responses with these agents the majority of patients fail to respond. The     investigators hypothesize that a novel strategy combining radiotherapy and intralesional     interleukin-2 (IL-2), a signaling molecule and member of the cytokine family involved in the     activation of leukocytes and lymphocytes, may overcome resistance to checkpoint blockade     therapy and offer significant clinical benefit to patients who fail to respond to checkpoint     blockade alone. The investigators propose a microtrial testing the feasibility of a bold     combinatorial immunotherapy strategy consisting of radiotherapy (RT), intralesional IL-2, and     check-point blockade for metastatic non-small cell lung cancer patients who have progressed     after checkpoint inhibition. IL-2 can upregulate PD-1 expression and activate T-cells.   "
254235|NCT03267589|"     The overall objectiv is to obtain preliminary evidence of efficacy of novel agents for the     management of relapsed ovarian cancer, and in part 2 efficacy of novel agents compared to the     standard of care (SoC).   "
254236|NCT03210220|"     In this study, the investigators will compare the intraoperative opioid The purpose of this     study is to determine whether pectoral nerves blocks（PECS） would reduces the opioid     consumption during the surgery and postoperative pain after breast cancer surgery.   "
254223|NCT03266757|"     Observational study of the Clinical Practice in patients with Borderline resectable or     resectable or advanced pancreatic adenocarcinoma.   "
254224|NCT03228381|"     The objective of the BOSS Study is to assess acute anatomical and geometric annular and     ventricular changes that occur when strategically positioned an external inflatable chambers     are applied to the outside of the heart.   "
254225|NCT03230916|"     This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of     imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single     intravenous (IV) dose of MK-7655A (a fixed ratio combination of     imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.   "
254226|NCT03220854|"     To determine if SRT and PD-1/PD-L1 inhibiting therapy can restore the benefit of PD-1/PD-L1     inhibiting therapy in patients with an advanced solid tumor who had clinical benefit from     PD-1/PD-L1 inhibiting therapy prior to progression.   "
254229|NCT03246464|"     Myopia is a common disease of the eye with increasing prevalence in the Western World as well     as in South East Asia where 60-90% of the children are affected. High myopia is associated     with an increasing risk of sight threatening complications such as retinal detachment,     glaucoma, macular choroidal degeneration and myopic choroidal neovascularization. In myopia     the eye is elongated compared to an emmetropic eye. If the elongation of the eye can be     controlled the progression of myopia can be controlled. Asian studies have shown reduction in     axial length growth by 36-46% in children using orthokeratology contact lenses (OKL). OKL are     custom fit, form stable lenses. During sleep the cornea is reshaped creating an emmetropic     vision during the day, so no glasses or contact lenses are needed. Twin and family studies     have shown a high heritability for the development of myopia, and more than 40 genetic loci     have been identified indicating that the effect of OKL in Asian children might not be the     same in North European children which is why we want to execute a similar study on North     European children.      Purpose:        1. Investigate if nightly wear of OKL reduces the progression of childhood myopia (change          in axial length) in Danish children when compared to a control group using monofocal          glasses.        2. Investigate the safety (Efron score) of OKL.        3. Investigate children's quality of life impact of refractive correction (questionnaire)          using OKL compared to glasses.        4. Identify possible predictors for progression of myopia (AC/A ratio, peripheral defocus          and higher order aberrations).      Method:      A randomized controlled 18 months prospective 1:1 study of a group of Danish children. 50     children will be included; 25 in each group. The participants will undergo several     measurements reflecting the anatomy and function of the eye at baseline, 6, 12 and 18 month     to evaluate the effect.   "
254356|NCT03106987|"     The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled,     multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus     matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including     patients with primary peritoneal and/or fallopian tube cancer).   "
254240|NCT03214224|"     The specific objective of this study is to validate the practice of remote pulmonary function     testing (rPFT) conducted in the home through the use of connected mobile health devices and     the Penn State Hershey ALS Telemanagement program.      The second part is a comparison of respiratory outcomes in patients receiving     telemedicine-guided respiratory assessments monthly vs. those receiving standard of care.     This is a randomized controlled study which assesses the effects rPFT on respiratory     outcomes, quality of life, and survival.   "
254244|NCT03205163|"     The primary purpose is to assess the safety and tolerability of a single intravenous (IV)     administration of BIVV001 in adult previously treated patients (PTPs) with severe hemophilia     A.   "
254247|NCT03215940|"     This is a study comparing the effects of Delta-9-Tetrahydrocannabinol (THC) versus     Cannabidiol (CBD) versus a placebo on chronic non-cancer pain.   "
254249|NCT03205605|"     This research study is intended to determine the effect of heat on oxybutynin products.   "
254252|NCT03206203|"     This randomized phase II trial studies how well carboplatin with or without atezolizumab     works in treating patients with stage IV triple negative breast cancer. Drugs used in     chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of     tumor cells to grow and spread. Giving carboplatin with atezolizumab may work better in     treating patients with stage IV triple negative breast cancer   "
254306|NCT03166319|"     This is a prospective pilot study to determine the utility of MRI and high resolution     intracranial vessel wall imaging for the diagnosis and disease activity assessment of     intracranial vasculitis.   "
254253|NCT03210155|"     The birth of a child is a major life event that can be filled with excitement, anticipation     and joy. However, the transition and adaptation to new demands, roles, responsibilities, and     changes in relationships can be stressful, especially for new mothers. In addition, new     mothers typically encounter physiological changes and struggle with concerns about weight     gain, body image, sexuality, and other physical difficulties such as fatigue. These problems     may generate or exacerbate stress, lead to an actual or perceived crisis and psychological     distress.      Psychological distress, defined as anxiety, depression, and insomnia, in this study, often     increases during the postpartum period and can negatively affect maternal mental health     status, maternal and family relationships, and infant-child health. The purpose of this study     is to evaluate the effects of cranial electrotherapy stimulation (CES) on anxiety, insomnia,     depression, and maternal functioning in first time new mothers following childbirth.   "
254254|NCT03231930|"     The Rapid-EC pilot study will determine feasibility of providing rapid point-of-care (POC)     testing for HCV in community clinics, and whether the availability of POC testing increases     uptake of testing, engagement in care and completion of treatment among people who inject     drugs.      The POC tests being utilised in this study are the OraQuick mouth swab test for the presence     of HCV antibodies, and the Xpert HCV RNA viral load test using serum.   "
254255|NCT03264950|"     Diagnosis of hepatic fibrosis is challenging as specific tests for detection of fibrosis in     pediatric Cystic Fibrosis associated liver disease (CFALD) have not been developed and     existing investigations do not correlate well with presence or severity of disease. Using a     Liver biopsy it is difficult to diagnose this condition because of the patchy nature of the     disease. Investigators intend to identify hepatic and pancreatic fibrosis in Cystic Fibrosis     patients using Elastography and correlate this with their biochemical markers as well as     histological findings of patients who have undergone liver biopsy for diagnosis of CFALD.   "
254256|NCT03200847|"     This is a Phase I/Ib investigator-initiated open label of the combination of VESANOID and     pembrolizumab treatment.   "
254261|NCT03198039|"     The primary purpose of this trial is to test the feasibility of implementing a meditation     program in the perioperative period.   "
254331|NCT03212963|"     The objective of this open-label multicentric study is to determine the adrenal suppression     potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice     daily for up to two weeks in subjects aged 12 to 16 years 11 months with stable plaque     psoriasis. Subject enrollment will continue until at least 20 subjects with both screening     and end of study (EOS) serum cortisol data (pre- and pos-tcosyntropin stimulation) have     completed the study without any significant protocol violations (evaluable subjects). This     may require the enrollment of approximately 25 subjects.   "
254263|NCT03194789|"     FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of     pelvic muscles. While there have been no published studies to our knowledge investigating the     effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that     create dynamics similar to dynamic lumbosacral stabilization exercises. The investigators     propose that FGBMM induces the same bio-mechanical improvements as LPSE (lumbopelvic     stabilization exercises) which have shown benefit for incontinence. Instead of instructing     patients to co-contract the lower trunk and pelvic floor muscles as commonly done for LPSE,     the shoes used in FGBMM can be calibrated in a way that causes this co-contraction to occur     without the patient realizing. Beneficial pelvis and spine positioning can also be     accomplished by strategic placement of the pods without having to instruct the patient on     complicated maneuvers. Capitalizing on the excellent adherence and clinical benefits of FGBMM     on related conditions, the investigators propose to evaluate the effects of FGBMM in addition     to pelvic floor therapy for improving the symptoms of stress urinary incontinence in an urban     inner city population.   "
254267|NCT03192176|"     This study is to determine the effects of different doses and dosing regimens of ESN364 on     the frequency and severity of hot flashes. The treatment will be administered for 12 weeks to     postmenopausal women, ages 40 to 65, suffering at least 50 moderate to severe hot flashes per     week.   "
254269|NCT03190798|"     RESEARCH HYPOTHESIS        -  In subjects with T2DM and HF, effect of canagliflozin will be superior to placebo for          the change from baseline in PCWP after a single dose (6 hours post-dose) and after 4          weeks.        -  Treatment with canagliflozin will be well tolerated over 4 weeks.   "
254358|NCT03102437|"     This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart     System with CCM therapy.   "
254272|NCT03189719|"     The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus cisplatin     and 5-fluorouracil (5-FU) chemotherapy versus placebo plus cisplatin and 5-FU chemotherapy as     first-line treatment in participants with locally advanced or metastatic esophageal     carcinoma.      The primary efficacy hypotheses are that both progression-free survival (PFS), according to     Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and determined by blinded     independent central review, and overall survival (OS) are superior with pembrolizumab plus     chemotherapy compared with placebo plus chemotherapy in all participants as well as     participants whose tumors are gene expression profile (GEP) biomarker-positive.   "
254274|NCT03198559|"     Antiretroviral therapy (ART) dramatically reduces Human Immunodeficiency Virus (HIV)     replication leading to restoration of immune function and a near normal life expectancy, but     treatment is lifelong and there is no cure. The major barrier to a cure is the persistence of     long lived cluster of differentiation 4 (CD4+) T-cells that contain a silenced form of HIV,     called HIV latency.      The purpose of this research is to investigate whether it may be possible to reduce the     amount of dormant HIV infection in immune cells, by turning on or activating the virus and     hence force it out of the latently infected memory T cells. This leads to production of HIV     by the cell, which will either die or will be recognized and eliminated by the immune system.     As very few T cells are latently infected with HIV, the death of these cells is not expected     to affect the function of the immune system and further infection of new cells is expected to     be prevented by ART.   "
254278|NCT03198390|"     Investigators will measure skin barrier function using noninvasive devices and sample their     skin and blood to study the expression anti-oxidative enzymes, skin barrier proteins and     inflammatory molecules. These results will be correlated with the disease severity in atopic     dermatitis patients.   "
254280|NCT03187353|"     This is a double-blind, placebo-controlled, crossover study testing whether Vyvanse     (lisdexamfetamine; LDX) improves executive functioning (EF) in 100 postmenopausal women who     report onset of EF difficulties after oophorectomy. This study involves magnetic resonance     imaging (MRI) to see how LDX affects brain chemistry while undergoing two 6-week trials of     the study drug and placebo capsules.   "
254281|NCT03225261|"     This randomized, parallel, double-blind, placebo-controlled trial aims to determine the     effects of daily administration of citrus extract over a period of 8 weeks on     gastrointestinal health in 2 different patient groups.   "
254282|NCT03185013|"     HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to     determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular     (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women     with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL)     (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human     papillomavirus (HPV) 16 and/or HPV-18.   "
254283|NCT03199911|"     The investigators propose a prospective randomized control trial testing the hypothesis that     routine topical antibiotic prophylaxis does not significantly reduce the rate of infection     after eyelid surgery.   "
254286|NCT03182751|"     A single-center, prospective randomized study. Consecutive patients presenting with     intertrochanteric hip fractures will be treated with tranexamic acid. Treatment will be     initiated in the emergency department according to a previously studied protocol for trauma     patients.   "
254288|NCT03180684|"     This phase 2, randomized, open label study will investigate the efficacy of VGX-3100 followed     by electroporation (EP) with CELLECTRA® 2000 alone or in combination with imiquimod in     participants with human papillomavirus (HPV)-16 and/or HPV-18 related high grade squamous     intraepithelial lesion (HSIL) of the vulva.   "
254289|NCT03264781|"     The purpose of this study is to determine that once-a-month injectable contraceptive(     Cyclofem® ) has the effect on treatment of irregular uterine bleeding in implant     contraceptive users or not.   "
254291|NCT03267771|"     Recurrent pregnancy loss is classically defined as the occurrence of three or more     consecutive pregnancy loss. The American Society of Reproductive Medicine has recently     redefined recurrent pregnancy loss as two or more pregnancy losses. A pregnancy loss is     defined as a clinically-recognized pregnancy means that the pregnancy has been visualized on     an ultrasound or that pregnancy tissue was identified after a pregnancy loss.   "
254293|NCT03178344|"     Transcranial Alternating Current Stimulation (tACS) is one method that has been demonstrated     to enhance alpha oscillations in healthy participants by applying weak electrical currents to     the scalp to modulate rhythmic brain activity patterns. This study will involve tACS-induced     frontal alpha oscillations, EEG recordings, and other physiological and biological measures.   "
254295|NCT03173924|"     Background:      Prostate cancer is the second leading cause of cancer deaths in American men. Few options     exist to create images of this type of cancer. Researchers think an experimental radiotracer     called 18F-DCFPyL could find sites of cancer in the body.      Objective:      To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease.      Eligibility:      People ages 18 and older who have metastatic prostate cancer      Design:      Participants will be screened with:        -  Blood tests        -  Physical exam        -  Medical history      Participants will be assigned to 1 of 2 groups based on their PSA.      Participants will have 18F-DCFPyL injected into a vein. About 2 hours later they will have a     whole-body Positron Emission      Tomography/Computed Tomography (PET/CT). For the scan, they will lie on their back on the     scanner table while it takes pictures of the body. This lasts about 50 minutes.      On another day, participants will have 18F -NaF injected into a vein. About 1 hour later,     they will have a whole-body PET/CT.      Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic     Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT     imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of     the pelvis.      If the 18F-DCFPyL PET/CT is positive participants will be encouraged to undergo a biopsy of     one of the tumors. The biopsy will be taken through a needle put through the skin into the     tumor.      Participants will be followed for 1 year. During this time researchers will collect     information about their prostate cancer, such as PSA levels and biopsy results.      About 4-6 months after scanning is completed, participants may have a tumor biopsy. The     biopsy will be taken through a needle put through the skin into the tumor.   "
254297|NCT03264430|"     Evaluation of the anesthetic quality and analgesic efficacy of adding ketamine to intrathecal     bupivavaine in selective saddle block for perianal surgery.   "
254315|NCT03179540|"     This is a 5 year Phase II study to evaluate the safety of non-operative management (NOM) in     patients with low rectal cancer (LRC) who achieve a complete clinical response (cCR)     following chemoradiotherapy (CRT). The safety of NOM will be evaluated by assessing (i) rate     of local re-growth and (ii) rate of macroscopically positive resection margin (R2) when     surgery is required due to local re-growth. NOM will be considered safe or as effective as     surgery to achieve local control if the rate of local re-growth is equal to or less than 30%     and the rate of a macroscopically positive margin is 0%.   "
254332|NCT03131050|"     Despite the availability of a wide range of antidepressant drugs, clinical trials indicate     that 30% to 40% of patients with major depression fail to respond to first-line     antidepressant treatment, despite adequate dosage, duration, and compliance. Moreover, in     those patients who do experience symptomatic relief following conventional anti-depressant     treatment, clinical improvement is not evident for 3-4 weeks. Thus, there is a clear need to     develop novel and improved therapeutics for unipolar depression.      A previous study showed that the intravenous administration of scopolamine produces     antidepressant effects. This study is designed to determine if scopolamine combine with     Escitalopram produce antidepressant effects at an early stage.   "
254300|NCT03173755|"     In order to better understand how pre-existing pain and also discomfort/enjoyment during     exercise may influence physical activity and be related to body weight the investigators are     seeking to examine these as they relate to overweight/obesity compared to normal weight     individuals. Ultimately, the investigators think that people with obesity may have more and     be more sensitive to pain and have lower discomfort tolerance that may lead them to     experience exercise more negatively. In the real world, this could result in them stopping     exercise sooner or avoiding exercise all together. Therefore it is important for the     investigators to begin to understand this issue better. In addition, some preliminary studies     in animals suggest that the quality of the diet may influence pain sensitivity. This has yet     to be examined in humans. As such the investigators will examine whether self-reported diet     quality and also some markers in participants' blood that can tell the investigators about     the recent quality of a person's diet, are related to the measures of pain, enjoyment and     discomfort during exercise.   "
254301|NCT03208543|"     This research studies the effect thermotherapy as treatment of Old World CL which is not     invasive, non-toxic, and the short treatment. While the current standard treatment comprise     daily painful injections with antimonials,   "
254305|NCT03167216|"     The objective of this study is to evaluate inhibition of mast cells and the histamine 1     receptor (H1R) for treatment of chronic prostatitis (CP) and chronic pelvic pain syndrome     (CPPS).   "
254307|NCT03165747|"     Osteoporosis has a devastating impact on quality of life of postmenopausal women, and is a     significant cause of disability and morbidity. Many drugs are approved for the prevention and     treatment of osteoporosis, but are associated with high costs and side effects. Some data     from animal studies suggests that supplementation with probiotics can safely treat and     prevent osteoporosis. The probiotic VSL#3 is commercially available, is safe for human     consumption, and has been widely used in human clinical trials, and has known     health-promoting effects in both children and adults.      The double-blind, randomized, placebo-controlled trial of VSL#3 will be conducted for 12     months in 40 postmenopausal women to determine if VSL#3 improves bone mineral density and     related bone markers. Study visits will include all or some of the following procedures: a     medical exam, urine collection, height and weight measurement, a blood draw to assess bone     biomarkers, a DEXA (dual energy X-ray absorptiometry) scan to measure bone density, and     health questionnaires.      This is one of the first clinical trials proposed to investigate the effects of probiotics in     bone in humans. If successful, this proposal will provide the first evidence that nutritional     supplementation with the probiotic VSL#3 is a safe and effective strategy for preventing     postmenopausal bone loss.   "
254309|NCT03160677|"     A randomized, multicenter study comparing two strategies: 1 / standard management of systolic     blood pressure according to international recommendations (systolic blood pressure <185 mm     Hg) versus 2 / intensive blood pressure management Systolic with a target <130 mm Hg.   "
254310|NCT03159416|"     This study is a Phase I, single-dose, open-label trial to evaluate the safety, tolerability,     pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC)     injection in participants with mild, moderate, and severe renal impairment compared to     participants with normal renal function.   "
254312|NCT03155724|"     The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to     demonstrate that the MPP feature is effective by converting a percentage of cardiac     resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a     single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028).   "
254313|NCT03157336|"     Investigators will implement a novel cassava processing method (wetting method, WTM) that     safely removes cyanogenic compounds from cassava flour prior to human consumption in a     stratified village-cluster randomized non-inferiority trial so as to compare the     effectiveness of a peer-led intervention (women training other women in the WTM) with that by     community-health worker specialists.   "
254314|NCT03152760|"     Background:      Alcohol use disorder (AUD) affects about 10 percent of people in the U.S. Studies show a     relationship between the bacteria (microbiota) in the gut and the brain. Researchers think     this may influence AUD. They want to learn more about changes in gut bacteria that may occur     in people with AUD.      Objectives:      To study gut microbiota differences in current drinking versus abstinent people with AUD.     Also to test if gut microbiota are related to alcohol cue-induced craving.      Eligibility:      People ages 21-65 who have AUD (both abstinent and current heavy drinkers) or are healthy,     moderate drinkers      Design:      Participants will be screened in Protocol 14-AA-0181.      Participants will have a first visit. They will have 4 more visits within about 10 days.     Visits include:      Fecal sample collection      Physical exam      Blood tests      Assessment of diet and alcohol use      X-rays to test body composition,      They will sit under a ventilation hood to measure metabolism. They must fast 12 hours before     this test.      They will drink a solution. Their urine is collected over 5 hours.      Ultrasound of the liver area. They must fast overnight before this test.      At 2 visits, they will be in a bar-like setting. They will be exposed to stimuli associated     with eating and drinking. They will rate their urge to drink alcohol and their food cravings.      Participants will collect their stool throughout the study. They will also record information     about their diet and daily activities like sleep and exercise.      At the end of the study, participants will discuss their drinking. They will receive     counseling if needed.   "
254316|NCT03153137|"     Clinical study assessing the efficacy and safety of macitentan in Fontan-palliated subjects.   "
254409|NCT03021499|"     The purpose of this study is to assess the efficacy of voclosporin compared with placebo in     achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.   "
254319|NCT03142334|"     The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475)     in the adjuvant treatment of adult participants who have undergone nephrectomy and have     intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma     (RCC) with clear cell component.      The primary study hypothesis is that pembrolizumab is superior to placebo with respect to     Disease-free Survival (DFS) as assessed by the Investigator in male and female participants     with intermediate-high risk, high risk and M1 NED RCC.   "
254321|NCT03267030|"     Pegylated-asparaginase (PEG-ASP) is an important part of the treatment of childhood acute     lymphoblastic leukaemia (ALL). Unfortunately 13% of patients develops allergy and further     treatment is impossible. Furthermore, 6% of patients have developed antibodies (silent     inactivation) and have no effect of the PEG-ASP treatment. Truncated asparaginase therapy is     associated with inferior event-free survival outcomes, in particular relapse in central     nervous system (CNS).      Eryaspase is a new formulation of asparaginase encapsulated in erythrocytes. The erythrocyte     membrane protects asparaginase against fast degradation and elimination processes. The     encapsulation eliminates the direct somatic contact, and it is hypothesized that this     provides the potential to prolong the activity of the enzyme and reduce toxicities.   "
254322|NCT03138499|"     The purpose of this study is to determine whether an investigational immuno-therapy     combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe     and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The     participants of this trial will comprise of patients who have relapsed or did not respond to     treatment and are not eligible for stem cell transplant   "
254323|NCT03145259|"     The study will utilize already FDA-approved marketed diclofenac products in healthy adults to     generate data for establishing rate of drug delivery comparisons between diclofenac epolamine     patches and diclofenac sodium solution in healthy adults and to determine skin     concentrations.   "
254325|NCT03139331|"     This is the first study to evaluate the safety and clinical activity of the combination of     oral pazopanib, intravenous or oral irinotecan, and oral temozolomide in pediatric and young     adult patients with relapsed or refractory sarcomas. This study will use a 3 + 3 design for     dose escalation (Part 1), followed by an expansion cohort (Part 2) at the recommended phase 2     dose level.   "
254326|NCT03139136|"     Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent     of patients don't respond to current treatments. MBS2320, the drug being tested in this     trial, represents a new approach to treating RA, with the potential not only to reduce levels     of inflammation but to also directly prevent bone damage.The aim of this project is to test     the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an     existing treatment, methotrexate.   "
254328|NCT03138395|"     This study will use droplet digital PCR (ddPCR) method to quantify and track peripheral blood     plasma mutant allele frequency (MAF) in MDS and AML patients before, during and after     chemotherapy treatment. Quantification of MAF from fingersticks and saliva samples will also     be performed to determine feasibility of obtaining adequate circulating tumor DNA (ctDNA) for     ddPCR.   "
254329|NCT03131791|"     Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and     improve upper limb function for post-stroke patients. However, there were no studies to     compare the effect of rESWT and BoNT-A injection for treatment on spasticity.   "
254330|NCT03134053|"     Assess the effect of extracorporeal shock waves on hypertrophy scar   "
254334|NCT03126942|"     The objective of this explanatory mixed methods study is to compare a novel attachment system     (Novaloc) to a traditional alternative (Locator) for single implants in the mandible of     edentate elders. The investigators will carry out a randomized cross-over clinical trial     comparing Novaloc attachments to Locators for single-implant mandibular overdentures in     edentate elders. Participants will be followed for three months with each attachment type;     patient-based, clinical and economic outcomes will be gathered. A sample of 26 participants     is estimated to be required to detect clinically relevant differences in terms of the primary     outcome (patient ratings of general satisfaction). Participants will choose which attachment     they wish to keep, then be interviewed about their experiences and preferences with a single     implant prosthesis and with the 2 attachments. Data from the quantitative and qualitative     assessments will be integrated through a mixed-methods explanatory strategy. A last     quantitative assessment will take place after 12 months with preferred attachment; this     latter assessment will enable the observation of attachments' long-term wear and maintenance     events.   "
254335|NCT03123133|"     To verify and validate a biodosimetry test for determining absorbed ionizing radiation dose     by analyzing gene expression signatures of blood samples collected from patients treated with     Total Body Irradiation (TBI).   "
254337|NCT03116828|"     A study of a drug to be used in addition with another drug to treat adults with Uncontrolled     Partial-onset Seizures   "
254340|NCT03117569|"     The aim of this study is to determine if treatment monitoring schedule for chronic HCV     patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified.      Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir     (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV     treatment simplification.      Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to     the standard or simplified monitoring arm and will receive treatment for 8 weeks.      One post treatment visit will be conducted 12 weeks after the final dose of study medication     to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).   "
254341|NCT03112226|"     Complaints about memory and thinking are common in women as they go through menopause. The     female hormone estrogen is important for both the health of both the brain and the blood     vessels. In Alzheimer's disease there is damage to the blood vessels in the brain. This study     will look at how the loss of the female hormone estrogen affects brain function and the     health of blood vessels.   "
254344|NCT03122873|"     The study is designed to quantitate McArdle's sign, an increase in measurable weakness with     neck flexion described in patients with multiple sclerosis, and to determine whether it is or     is not specific for multiple sclerosis.   "
254454|NCT02967900|"     An open, non-randomised longitudinal study of diabetic foot ulcers receiving standardised     treatment, over a 16 week period conducted at out-patient level, utilising novel optical     wound measurement technologies.   "
254359|NCT03096431|"     To determine the feasibility of processes and instruments with an overarching purpose to     guide the design of a larger study. To determine the feasibility of individuals with     metastatic brain tumor(s) to engage in physical activity(PA) and cognitive rehabilitation     (CR) as in an outpatient therapy setting.   "
254360|NCT03098030|"     This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan     versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer     (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and     tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed     to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with     irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3     treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan.     Randomization will be stratified by duration of response to prior platinum therapy     (relapse-free period <3 months or ≥3 months).   "
254361|NCT03093493|"     We are planning to collected blood and saliva for DNA extraction to use for genetic testing     of children and adults with EDS and their relatives. Medical records from other institutions     and clinical notes for visits in Dr. Holick's clinic will be reviewed to obtain the following     information: previous diagnosis at other institutions, age, clinical signs and symptoms of     EDS, Joints Hypermobility Syndrome (JHS), , and other metabolic or genetic disorders and     laboratory results, radiology reports and images, and genetic testing that supports these     diagnoses. Subjects' peripheral vein blood and saliva will be taken. No clinical     intervention/randomizations will be performed. No patients' identifiers will be reported.      In this pilot study genomic DNA will be extracted and will be used for genotyping as     sequencing in 30 EDS patients and their 30 relatives with or without EDS to compare genetic     variations between them. After validation by Sanger sequencing for these variations, we plan     to prepare a genetic panel for EDS. After all validation testing, we plan to evaluate the     saliva DNA in a similar manner and compare the results with those obtained from the DNA from     the blood sample. The purpose is that if they are comparable, we will be able to use saliva     in place of blood as it easier method for accessing a person's DNA. This will be especially     helpful for evaluating infants or those patients who prefer not to have a blood sample drawn.   "
254364|NCT03101839|"     A Phase I, open-label, multicentre, dose-escalation study to investigate the safety,     pharmacokinetics and maximum tolerated dose (MTD) of AZD4785 in patients with advanced solid     tumours where KRAS may be an important driver of tumour survival.      Part A: Dose escalation in patients with solid tumours to evaluate safety, pharmacokinetics     and dose      Part B: Expansion cohort at the selected dose in patients with non small cell lung cancer to     evaluate pharmacodynamics and clinical response   "
254367|NCT03090997|"     Hormonal and metabolic changes because of postmenopause increase body weight, central     abdominal fat, alter lipid profile and insulin resistance, those factors increase the risk up     to 60% to develop metabolic syndrome, diabetes and cardiovascular diseases. Because there is     no efficient antioxidant therapy in postmenopausal women, this study proposes a therapy with     resveratrol and vitamin C to increase the total antioxidant capacity; as well as to decrease     insulin resistance and in consequence decreased the risk of diabetes, metabolic syndrome and     cardiovascular disease   "
254368|NCT03087058|"     The purpose of this study is to evaluate the change in serum (blood) potassium levels from     start of treatment to Day 14, when patiromer is administered at different doses, once daily,     in children 2 - < 18 years of age with chronic kidney disease (CKD) and hyperkalemia (too     much potassium in the blood). Another purpose of the study is to evaluate the safety and     tolerability of patiromer in children 2 - < 18 years of age with CKD and hyperkalemia.   "
254369|NCT03096938|"     The purpose of this study is to evaluate the role of cell-free DNA methylation markers in     cancer screening.   "
254380|NCT03065959|"     The purpose of this study is to investigate the effect of CK-2127107 versus placebo on     skeletal muscle fatigue assessed as change from baseline versus 14 days of treatment in sum     of peak torque during isokinetic knee extensions.      This study will also assess the effects of CK-2127107 on physical performance via a short     physical performance battery (SPPB), stair-climb test and 6 minute walk test.   "
254381|NCT03066778|"     The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard     of care (SOC) chemotherapy (etoposide/platinum [EP]) in participants with newly diagnosed     extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic     therapy for this malignancy.      The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival     (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded     independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult     participants with ES-SCLC.   "
254382|NCT03066804|"     The purpose of this study is to demonstrate the superiority of LCZ696 over individualized     medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide     (NT-proBNP) and improving HF symptoms and functional capacity in patients with heart failure     with preserved ejection fraction (HFpEF).   "
254384|NCT03136614|"     To investigate how pulse wave velocity, aortic augmentation index and the arterial pulse wave     given by the Arteriograph contributes to preoperative assesment, intraoperative and intensive     care monitoring.   "
254395|NCT03045029|"     This is a prospective, observational, multicenter, patient registry to observe and assess the     real-world use and tolerability of Orenitram (treprostinil). Patients who are newly initiated     on Orenitram for the treatment of pulmonary arterial hypertension (PAH) or who transition     from another prostacyclin therapy will be evaluated for 52 weeks to observe dosing regimens,     titration schedules, prostacyclin-related adverse events (AEs), and clinical outcomes of     interest.   "
254389|NCT03065088|"     The feasibility randomised controlled trial is part of the EU funded project PreventIT     (2016-2018) responding to the Horizon 2020, Personalised health and care (PHC), call PHC-21:     Advancing active and healthy ageing with ICT: Early risk detection and intervention. The     PreventIT project focuses on a new behaviour change activity approach for young older adults     (61-70 years of age) with an overall aim of early prevention of functional decline and to     empower people to take care of their own health.   "
254392|NCT03051490|"     Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived     lipase, protease, and amylase digestive enzymes. The purpose of the present study is to to     evaluate the non-inferiority of liprotamase compared with porcine-derived, enterically-coated     pancreatic enzyme replacement therapy (PERT). The primary efficacy endpoint of the study will     be comparative efficacy measured as the change from baseline in the coefficient of fat     absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).   "
254396|NCT03046927|"     This project is designed to study the role of vitamin D supplementation on the honeymoon     phase of type 1 diabetes in children who are on standardized insulin treatment. The results     could lead to significant changes in the approach to the early phase of type 1 diabetes with     a strong emphasis on prolonging the honeymoon phase by using vitamin D and maintaining these     patients on a standardized insulin regimen. The overall goal is to reduce the long-term     complications of type 1 diabetes.   "
254398|NCT03042221|"     A comparison of baseline tumor characteristics in EGFR mutant lung cancers to tumor     characteristics after early response of EGFR-TKI targeted treatment to allow identification     of early adaptive mechanisms of cell survival in the setting of oncogene-targeted therapy.     This identification will facilitate targeting and termination of these survival/resistance     pathways before they develop with rational combination of therapeutic agents to improve     outcomes.   "
254399|NCT03036488|"     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475)     plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs     placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).      After a screening phase of approximately 28 days, each participant will receive neoadjuvant     study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the     randomization schedule for approximately 24 weeks (8 cycles). Each participant will then     undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant     study treatment. After definitive surgery, each participant will receive adjuvant study     treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following     adjuvant study treatment, each participant will be monitored for safety, survival and disease     recurrence.      The primary study hypothesis is that pembrolizumab is superior to placebo, in combination     with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or     Event-free Survival (EFS), in participants with locally advanced TNBC.   "
254403|NCT03030183|"     The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with     Paroxysmal Nocturnal Hemoglobinuria (PNH) who have an inadequate response to eculizumab.     Patients will be treated with RA101495 for 12 weeks.   "
254404|NCT03027986|"     Urinary incontinence (UI) is defined by the International Continence Society as any     involuntary loss of urine complained by the patient. The anatomical and histological     specificities of the pelvic floor muscles (PFM) give them a key role in the control of     urination but also in the control of postural stability. These activities are involuntary     automatisms and the mechanisms that lead to post-prostatectomy stress urinary incontinence     are not only due to the loss of voluntary contraction of the pelvic floor muscles. The     mechanisms that lead to UI are more complex and may involve the loss of efficacy of all deep     muscle stabilizing lumbo-pelvic region. Rehabilitation of pelvic floor muscles is recommended     in the treatment of urinary incontinence after prostatectomy (Grade A), but there is a lack     of evidence to define the best treatment regimen for PFM rehabilitation.      Two kinds of PFM rehabilitation are are commonly practiced by specialized physiotherapists.        -  The first one is made in individual box, in supine position. By analytic contractions of          the PFM, (exercises of Kegel type) +/- associated with an instrumental biofeedback. This          method used voluntary contractions of MPP.        -  The second is realized in various positions following a gravity progression, in          individual and /or common room. This technique aims to restore a stabilization of the          entire lumbo-pelvic region by postural recruitment involving synergistic contractions of          the PFM.      These trials propose to compare these two rehabilitation programs on populations with     postoperative follow-up of more than 12 months.      We chose to objectify the urine leaks with the pad test (weighing of the protections urinary     over a period of 3 times 24h) which will be our main evaluation criterion. The home test pad     of 3 times in 24 hours has been used by numerous studies and its reproducibility and     reliability are established.      Urinary incontinence is a recognized factor of sedentary lifestyle, fatigue, impaired mental     health and decreased of physical fitness. We therefore wish to observe these parameters for     each of our two randomized groups   "
254405|NCT03027999|"     Rheumatoid arthritis (RA) is a progressive disease that affects mainly small and medium     joints and, in the absence of appropriate background therapy, leads to progressive joint     destruction, functional, psychological, social and occupational repercussions.      Several biomedicine treat this pathology, including rituximab (RTX). It is recommended to     evaluate the therapeutic response to RTX and re-administer it from the 24th week when the     goal of remission has not been achieved. However, the optimal modality for reprocessing     remains to be determined.      To this end, different approaches have been explored, such as lymphocyte typing or ultrasound     monitoring. The pace of these examinations, however, remains wide and their cost is not     negligible. This is why we propose here to explore the track of a tight follow-up nurse     DAS28.      The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier     than the current medical follow-up.      The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier     than the current medical follow-up   "
254406|NCT03026686|"     This is a retrospective chart review of women who labored and delivered in a single health     care center. From that large group the investigators will evaluate women who were re-admitted     in the post partum period for a hypertensive disorder. The study will also look at     Controls, a group of women with similar risk factors but did not require readmission.   "
254587|NCT02793310|"     The purpose of this study is to determine whether corneal transplantation by Descemet     Membrane Endothelial Keratoplasty more favourable and cost-effective is compared to Descemet     Stripping Automated Endothelial Keratoplasty for Fuchs Endothelium Corneal Dystrophy.   "
254407|NCT03028597|"     The objective of this study is to reduce the effects of stereotype threat on the adherence of     African American patients with hypertension.      The specific aims of this study, which employs a values affirmation intervention, are to:        1. Compare the effects of the values-affirmation exercise to a control condition on          antihypertensive medication adherence in African American patients with uncontrolled          hypertension across three clinical settings,        2. Compare the effects of the values-affirmation exercise on antihypertensive medication          adherence in African American patients and white patients with uncontrolled hypertension          and similar socioeconomic characteristics, and        3. Evaluate the intervention for widespread dissemination using the RE-AIM (reach,          effectiveness, adoption, implementation and maintenance) framework   "
254410|NCT03018249|"     This randomized phase II trial studies how well medroxyprogesterone acetate with or without     entinostat before surgery works in treating patients with endometrioid endometrial cancer.     Medroxyprogesterone acetate is a progesterone, a hormone produced by body normally.     Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Given medroxyprogesterone acetate with or without entinostat may work better in     treating patients with endometrioid endometrial cancer.   "
254411|NCT03019588|"     The study will compare the efficacy and safety of treatment with pembrolizumab (MK-3475)     versus paclitaxel in Asian, programmed death-ligand 1 (PD-L1) positive participants with     advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after     failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent.      The primary study hypotheses are that pembrolizumab prolongs Overall Survival (OS) compared     to paclitaxel and that pembrolizumab prolongs Progression-free Survival (PFS) per Response     Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by blinded central     radiologists' review compared to paclitaxel.   "
254412|NCT03029611|"     This phase II trial studies how well pUMVC3-IGFBP2 plasmid deoxyribonucleic acid (DNA)     vaccine (IGFBP-2 vaccine) and combination chemotherapy work in treating patients with stage     III-IV ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery. IGFBP-2 is a     protein found in the blood and tumor cells of most who have been diagnosed with ovarian     cancer. Too much IGFBP-2 has been associated with more invasive disease. Vaccines made from     DNA may help the body build an effective immune response to kill tumor cells that express     IGFBP-2. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Giving IGFBP-2 vaccine and combination     chemotherapy may work better in treating patients with stage III-IV ovarian, fallopian tube,     or primary peritoneal cancer undergoing surgery.   "
254419|NCT03008382|"     Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) afflicts 3 to 8 million women in the US.     Symptoms of IC/BPS reduce quality of life, suppressing both social well-being and physical     function. The chronic pain, voiding dysfunction, sleep deprivation and associated co-morbid     conditions interfere with relationships and employment with significant direct (doctor     visits, medication, surgery) and indirect (loss of productivity) economic impact, currently     exceeding $100 million per year.This proposal aims to move the science of chronic pelvic pain     (CPP) from simple associations towards an investigation of cause and effect relationships.     The investigators will determine whether the striking changes in autonomic nervous system     responsiveness (ANS-R) contribute meaningfully to the pathogenesis of IC/BPS.   "
254420|NCT03009396|"     An open label extension to the RHB-104-01 Study.   "
254421|NCT03005548|"     The primary objective of this single center, prospective, randomized, double blind clinical     trial is to evaluate the effectiveness of anodal transcranial direct current stimulation     (tDCS) combined with patient controlled analgesia (PCA) morphine, on intravenous morphine use     for postoperative analgesia after thoracotomy. The intervention group will receive treatment     with anodal tDCS, whereas the control group will receive sham stimulation.   "
254425|NCT03039933|"     The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03)     is to address the critical need of identifying and decreasing fear of hypoglycemia, which     will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy     of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in     adolescents with Type 1 Diabetes (T1D) and their parents.   "
254426|NCT03030469|"     The goal of this research is to investigate the impact of changing opioid analgesic     prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult     dentistry settings. We will change prescribing defaults for select short-acting opioid     analgesics including immediate release oxycodone and hydrocodone as well as codeine and     tramadol, including their co-formulations with acetaminophen. In a cluster-randomized trial     of three Montefiore Medical Center dentistry sites, we will evaluate the impact of this     intervention on patient-level outcomes using 18 months of data (6 months pre-intervention and     12 months post-intervention).   "
254427|NCT02994953|"     The study consists of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B).     The dose escalation phase will evaluate the safety, tolerability, and PK of avelumab in     combination with NHS-IL12 in subjects with locally advanced, unresectable, or metastatic     solid tumors. Expansion phase will assess the safety and clinical activity of the combination     regimen in selected tumor types. In Expansion phase subjects who have completed the     combination treatment of avelumab at a given dose level of NHS-IL12, a safety review will be     performed by the Safety monitoring committee in order to make a decision on the next dose     level. Successive cohorts of 3 to 6 subjects will be treated with escalating doses of     NHS-IL12 with avelumab intravenous (IV).   "
254428|NCT02991859|"     This is a randomized, placebo-controlled, 2-period crossover, escalating repeat dose study,     aiming to investigate whether higher potency of different inhaled corticosteroid confers an     improvement in the topical efficacy to systemic activity ratio in asthmatic subjects. It will     compare the dose response for topical efficacy via airway responsiveness (to     adenosine-5'-monophosphate [AMP] challenge), and the dose response for systemic activity via     24 hour plasma cortisol suppression, and thereby compare the relative therapeutic index, for     the following inhaled corticosteroids: fluticasone furoate (FF), fluticasone propionate (FP)     and budesonide (BUD).      There will be a screening visit 7-28 days before the first dose of study treatment, and a     minimum 4-day run-in period before the first dose of study treatment. Subjects will be     randomized to one of 12 treatment sequences, and will have two treatment periods, each     comprising 5 consecutive 7-day phases of escalating doses of either FF, FP, BUD or placebo.     There will be a 25- to 42-day washout period between treatment periods. The study duration     for each subject will be approximately 22 weeks including the follow-up period.   "
254430|NCT03070938|"     The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective,     observational study for patients who have received PuraPly AM which consists of a collagen     sheet coated with polyhexamethylenbiguanide hydrochloride (PHMB) and is intended for the     management of wounds; no experimental intervention is involved.   "
254431|NCT03010852|"     Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are     common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and     even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its     success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on     patient compliance with IS effort and frequency. The investigators hypothesize that a focused     education preoperatively on IS for POH and intensive monitoring of patient compliance with IS     therapy in the early postoperative period shortens postoperative oxygen therapy, decreases     POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients     receiving standard of care.   "
254432|NCT03003832|"     The goal of this research is to investigate the impact of changing opioid analgesic     prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult     primary care and emergency department settings. We will change prescribing defaults for     select short-acting opioid analgesics including immediate release oxycodone and hydrocodone     as well as codeine and tramadol, including their co-formulations with acetaminophen. In a     cluster-randomized trial of matched pairs of Montefiore Medical Center clinical sites,     stratified by specialty and teaching status, we will evaluate the impact of this intervention     on patient-level outcomes using 18 months of data (6 months pre-intervention and 12 months     post-intervention).   "
254434|NCT03070925|"     The PuraPly AM case series is a prospective, observational study for patients who have     received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene     biguanide hydrochloride (PHMB) and is intended for the management of wounds; no experimental     intervention is involved.   "
254435|NCT02996305|"     The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol)     in adult subjects with Angelman syndrome. In addition, several exploratory efficacy outcome     measures will be investigated.   "
254436|NCT03266562|"     The primary objective of this study is to determine the correlation between the distribution     of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of     the breast, and the distribution of cells stained ER+ within the tumor by     immunohistochemistry (IHC) measurements at surgical pathology. The secondary aim is to     determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as     imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the     tumor.   "
254437|NCT03057574|"     This study aims to record Efficacy, Safety and tolerability of Gonapure® prescribed for     female subjects with infertility Undergoing IVF/ICSI   "
254438|NCT02992015|"     Diffuse Intrinsic Pontine Glioma (DIPG) is an aggressive childhood brain tumor that, despite     many past clinical trials, has never been shown to respond to chemotherapy. Radiation therapy     (RT) is effective in extending life but is not curative; median overall survival is 11     months. It is still unclear why the hundreds of clinical trials involving chemotherapy of     DIPG have failed to demonstrate any activity against the tumor. Given that many agents tried     in clinical trials cross the blood brain barrier (BBB), it is possible that there are factors     specific to DIPG and its location that prevent adequate drug penetration. Gemcitabine has     been selected for this study because there is strong evidence of DIPG cell line inhibition in     vitro and good BBB penetration. Furthermore, pediatric dosing and toxicity has been     established in prior studies of children with relapsed solid tumors and leukemia.      The primary aim of this study is to determine the presence of gemcitabine in childhood DIPG     tissue after systemic treatment with the drug. The secondary aim is to quantify the     intratumoral gemcitabine concentration after systemic treatment.      Participants in this study will be given a one time IV dose of gemcitabine prior to having     standard of care surgery. During surgery biopsies will be obtained for clinical and research     purposes along with a blood sample. Because patients will be undergoing this biopsy as part     of their standard of care therapy here at Children's Hospital Colorado, this is an optimal     time to obtain a tumor biopsy for this study. The biopsy will serve to see if the study drug     is penetrating the tumor. Patients will then enter a follow-up period for 30 days post     surgery.   "
254439|NCT02983318|"     In a number of neuropsychiatric disorders such as depression, both brain inflammation and     glutamate mediated excitotoxicity (cell death through over-activated stimulation) are     suspected to play a key role. It is difficult, if not impossible, to determine the potential     destructiveness of the inflammatory response seen in disease states by studying the brain's     inflammatory cells (microglia) activity in isolation. The investigators are proposing to     develop the means to concurrently study inflammatory response (i.e., microglial activity) and     its potentially devastating consequence (i.e., glutamate excitotoxicity) across the entire     brain in order to establish the importance of inflammation. In this study the investigators     propose a phased clinical study whereby the early-phase involves the development of our     capacity to study inflammation-mediated damage to brain cells, followed by a feasibility     study in patients with clinical depression that tests whether concurrent inflammation and     glutamate excess could be measured in key brain regions associated with a depressed mood     state.   "
254440|NCT02977299|"     This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment     arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing,     stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a     therapeutically sufficient dose for a sufficient treatment period, which would be expected to     be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ).     Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a)     aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR.   "
254449|NCT02966028|"     The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg)     compared to placebo on the progression of absolute change in coronary artery calcium volume     score over a 12‑month (52 weeks) period in ESRD patients on HD   "
254450|NCT02967055|"     This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of     isotretinoin on the etonogestrel (ENG) contraceptive implant.   "
254453|NCT02964325|"     This is a prospective, multi-center, controlled, randomized, non-inferiority study to     evaluate the clinical effectiveness of Conventional versus Mirasol-treated apheresis     platelets in subjects with hypoproliferative thrombocytopenia who are expected to have     platelet count(s) ≤ 10,000/μL requiring ≥ 2 platelet transfusions.   "
254455|NCT02960594|"     This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity     of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects     with high-risk solid tumor cancer with no evidence of disease after surgery and standard     therapy. Subjects will be enrolled into one of six treatment arms. Subjects will be assessed     according to standard of care. Restaging and imaging studies will be performed to assess     disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of     relapse.   "
254456|NCT02957149|"     Can platelet rich plasma applied to nerve bundles at time of surgery help the nerve bundles     heal? Subjects undergoing a Radical Prostatectomy who meet study inclusion/exclusion criteria     will be consented to receive an intraoperative application of platelet-rich plasma, made from     their own blood at the time of surgery, for application onto their neurovascular bundles in     an effort to improve the healing process. Subjects will be followed for an additional 18     months to determine the efficacy and safety of this procedure.   "
254460|NCT02952508|"     This study evaluates CLR 131 in patients with select B-cell malignancies (multiple myeloma(     MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL),     lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL),     and diffuse large B-cell lymphoma (DLBCL) who have been previously treated with standard     therapy for their underlying malignancy.   "
254463|NCT02981381|"     The investigators propose a small, two-site, sham-controlled pilot study of synchronized     Transcranial Magnetic Stimulation (sTMS) in patients with comorbid post-traumatic stress     disorder (PTSD) and depression. It is hypothesized that sTMS will be effective for PTSD and     mood symptoms.   "
254464|NCT02945618|"     The objective of this exploratory randomized control trial is to compare, in participants     with acute lateral ankle sprain (LAS) , the reduction of symptoms and functional limitations     between two groups of subjects who undergo a conventional rehabilitation program with     (experimental group) or without CRYOFOS (comparison group). The hypothesis is that CRYOFOS     will lead to a faster reduction of symptoms and functional limitations, and a faster return     to daily living activities.Thirty-six participants of 18 years of age and older with acute     LAS (sustained a LAS three days or less before the first evaluation session) will be     recruited and randomly assigned to either a group receiving conventional rehabilitation     program with the addition of CRYOFOS (experimental group; n=18), or to a group only receiving     the conventional rehabilitation program (comparison group; n=18). This single-blind     (evaluator), parallel-group RCT will include five evaluation sessions over 6 weeks (baseline,     day 7, week 2, week 4 and week 6) and 8 treatment sessions (1st and 2nd weeks: 3     sessions/week; 3rd and 4th weeks: 1 session/week) during a 4-week period. The primary outcome     will be the functional limitations, evaluated using the Lower Extremity Functional Scale     (LEFS).   "
254465|NCT02945657|"     The purpose of this study is to assess the pharmacokinetic parameters and safety of topical     MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use     conditions.   "
254467|NCT02939963|"     Patients who are intubated and mechanically ventilated for acute respiratory failure in the     Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them     from mechanical ventilation is to screen criteria for feasibility and, if present, to test     feasibility by performing spontaneous breathing trial. This latter can be done either by     setting a low pressure support level (expected to compensate the airflow resistance due to     endotracheal tube) or by allowing the patient to breathe spontaneously through the tube     without any support from the ventilator. Combination of low pressure assistance strategy (7     cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit.     Such a low pressure support level should actually result in a real assistance and, hence this     is not the real spontaneous breathing capacity that is tested. Some ICU ventilators offer the     option of compensating for the airflow resistance due to endotracheal tube, automatic tube     compensation (ATC). Therefore, investigators aimed at comparing in patients ready to wean the     usual procedure in our ICU and the ATC mode. In the ATC arm, the patients are breathing     spontaneously through the endotracheal tube and are connected to the ventilator set at     inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on.      Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm     H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work of     breathing. The hypothesis is that the power of the work of breathing is greater in ATC than     in the usual procedure, and hence this latter is a real ventilator support.   "
254468|NCT02937688|"     To gather data on DBS Therapy effectiveness in different geographic populations.   "
254469|NCT02940626|"     The purpose of this study is the prevention of Staphylococcus aureus pneumonia in     mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a     human pathogenic bacterium that causes severe infections, including pneumonia and sepsis.     Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including     ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a     significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is     an investigational monoclonal antibody product that targets the toxins produced by S. aureus     to protect subjects from developing S. aureus pneumonia.   "
254473|NCT02923570|"     Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy     tissues. It is possible that side effect rates with PBRT will be lower or the same compared     to IMRT, but this has not been well studied to date. Although both of these radiation     therapies have been used in the past to treat head and neck cancer, this research study will     compare the effects of these two different radiation treatment modalities with each other to     see whether PBRT is better, the same or worse than IMRT.   "
254533|NCT02864043|"     The NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for     participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are     scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a     standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure     called VLE (volumetric laser endomicroscopy).   "
254828|NCT02285062|"     To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide,     doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab,     cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in     patients who have previously untreated ABC type DLBCL.   "
254476|NCT02921503|"     The study aims to evaluate the effectiveness of a mobile application to assist in the     prescription of topical corticosteroids (TCS), focusing on best fit choices of potency,     vehicle and volume. The mobile application will be developed from the results obtained in a     systematic literature review and quality assessment of clinical practice guidelines for     topical corticosteroid use. The quality of the guidelines will be assessed using the AGREE II     tool. After the app user enters in information concerning patients' rash location and desired     treatment duration, the app will generate a list of recommended topical steroids (focusing on     specific quantity and potency) for the patient's particular area of need. The objective of     the study is to evaluate whether the use of a standardized application will change     prescribing practices for primary care physicians, physician assistants and nurse     practitioners.   "
254477|NCT03002896|"     The proposed project is a pilot randomized control trial of the Pep-Pal (Psychoeducation and     Skills Based Intervention) versus a treatment as usual control group. A total of 120     caregivers; 40 caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation), 40     caregivers of patients enrolled in phase I oncology trials, and 40 caregivers of patients     with advanced cancer (Stage IV, solid tumor) will be enrolled in this study. The     investigators do not expect different outcomes from these three groups, rather these     populations are selected to optimize recruitment within a short time frame. The caregivers     will be randomized to either treatment as usual or Pep-Pal intervention.   "
254478|NCT02918292|"     This study is a prospective, simultaneous, parallel phase II study with one arm receiving     unrelated cord blood transplantation and the other arm receiving haploidentical     transplantation for Severe Aplastic Anemia (SAA) patients. The primary objective is to assess     overall survival (OS) separately in the 2 arms at 1 year post-hematopoietic stem cell     transplantation (HSCT).   "
254482|NCT03240198|"     Chronic obstructive pulmonary disease (COPD) is a frequent disease, mainly linked to tobacco     smoking leading to chronic respiratory failure. It is characterized by an inflammatory spate     with modification of protease-antiprotease and oxidant-antioxydant balances. Local     modifications are associated with systemic changes. Many occupational factors have been     associated with an excess of COPD in epidemiological studies, however without identification     of any specific clinical or biological phenotype.      Pathophysiological pathways involved in COPD might be different according to etiologic     agents. Therefore, it is important to focus research on blood biomarkers associated with some     well-characterized occupational COPD.      The objectives of MB2PROF project are:        1. To build the first multicentric cohort of cases of occupational COPD, with collection of          plasma and DNA samples,        2. To study the evolution of clinical and lung function parameters of occupational COPD in          comparison with non occupational COPD during a follow-up study,        3. To identify biological phenotypes of COPD associated to a given etiological agent.      The methodology includes:        1. The constitution of a cohort with a clinical and biological follow-up during 5 years.          Subjects will be recruited in 7 occupational diseases departments, with the          collaboration of Pneumology departments.           Four groups of males subjects will be recruited (G1 : occupational COPD (6 groups of 60          subjects, corresponding to 6 groups of occupational agents) ; G2 : non occupational COPD          (n = 60) ; G3 : subjects with similar occupational exposure to G1 subjects but without          COPD (6 groups of 60 subjects) ; G4 : subjects free of occupational exposure and of COPD          (n = 60)), paired on tobacco-smoking and age. For each subject, information on clinical          data, lung function parameters, occupation history and blood samples will be collected.        2. The identification of biomarkers, using proteomic and genomic approaches according to          subgroups (with different etiologies) of occupational COPD,        3. The study of molecular pathways identified in these subgroups, with in vitro and in vivo          studies The MB2PROF project is an original and ambitious multidisciplinary and          translational project. The constitution of well-characterized COPD cases cohort should          allow the identification of biomarkers and molecular pathways associated with some          subgroup of subjects, and improve the knowledge of mechanisms involved.   "
254483|NCT02914561|"     The primary objectives of this study are to evaluate the safety and efficacy of filgotinib     during induction and maintenance treatment of moderately to severely active Crohn's disease     (CD) in participants who are biologic-naive and biologic-experienced.      Participants who complete the study, or do not meet protocol response or remission criteria     at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead     Study GS-US-419-3896).   "
254500|NCT03088397|"     Effective physician-patient communication in postpartum contraceptive counseling is essential     for patients to meet their contraceptive needs and reduce the risk of rapid repeat     pregnancies. This project will utilize a patient decision aid to facilitate shared decision     making in the immediate postpartum setting, assess the effectiveness of such aid in decision     quality and decision-making process quality, and observe its effects on contraceptive     choice mix at the time of discharge.   "
254484|NCT02915874|"     The goal of this study is to evaluate the effectiveness of a brief, intensive 1-day     psychotherapy group intervention (Acceptance and Commitment Therapy, ACT), compared to a 12     week time control group on anxiety symptoms, vascular function, inflammation, muscle     sympathetic nerve activity (mSNA), and oxidant stress. Similar measures will be performed at     baseline in individuals with low or no anxiety for comparison. Individuals who are interested     in the study will be identified by an online screening survey and will be contacted by the     research team; advertisements, flyers and mass emails will direct individuals to the online     screening survey. Those deemed eligible to participate will be randomized to the ACT     intervention or a control group. Assessments of anxiety symptoms (via various surveys) and     vascular function (via non-invasive, well-established techniques) will be performed at     baseline and 12 weeks post-ACT group intervention session. In addition, reassessment of     anxiety symptoms via aforementioned surveys will take place 6 weeks post-ACT group session.     After 12 weeks, anxiety and vascular assessments will be repeated to re-evaluate severity of     anxiety symptoms, vascular function, inflammation, and oxidant stress.   "
254486|NCT02913131|"     This is a single center prospective imaging study investigating the utility of hyperpolarized     C-13 pyruvate as a Biomarker of PI3K/mTOR pathway inhibition in patients with advanced solid     tumor malignancies. The current protocol will serve as a companion imaging biomarker study     paired with therapeutic trials of PI3K/mTOR pathway inhibitors (e.g. CUDC-907, BYL719), as     well as a stand-alone protocol for patients treated with standard-of-care therapies     inhibiting the PI3K/mTOR signaling pathway (eg. everolimus).   "
254534|NCT02854033|"     Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging     Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD.     ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been     combined public/private collaborations between academia and industry to determine the     relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker     characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the     study is to continue to discover, optimize, standardize, and validate clinical trial measures     and biomarkers used in AD research.   "
254830|NCT02278965|"     The purpose of this study is to determine whether it is feasible to give a combination of     Metformin and OMEGA-3 fatty acids for one year to women with a history of early stage breast     cancer. We will also evaluate whether the metformin and OMEGA-3 fatty acids combination     causes changes in breast tissue, blood, and mammograms.   "
254489|NCT02917954|"     Canadian and international health care systems require solutions on how to address the needs     of a relatively small population that take up a large portion of health care resources. In     Ontario, 10% of the population accounts for 79% of total system costs, with similar trends     found in other parts of Canada and internationally. Most high-cost users are seniors, older     adults, with multiple chronic conditions and complex care needs who are living in the     community. Beyond the cost issues, older adults experiencing multi-morbidity are at     higher-risk of poor health outcomes and experience lower quality of life as compared to     individuals experiencing single illness only.      Since April 2013 the electronic Patient Reported Outcomes (ePRO) mobile application and     portal, has undergone a multi-phased, user-centred design evaluation approach to develop a     tool designed to meet the needs of older adults with complex care needs and their primary     care providers. The ePRO tool is designed to collect person-centred, person-reported     indicators to improve care by supporting primary care delivery and enhancing patient     self-management.      The ePRO tool includes two features: 1) My Goal Tracker and 2) Health Journal. My Goal     Tracker allows patients and providers to collaboratively create goal-oriented patient     care-plans, and helps patients to track outcomes related to their goals using a mobile     device. The Health Journal allows patients, their caregivers and primary care providers to     monitor patients' symptoms and outcomes. The ePRO tool was re-evaluated and modified     following each previous study phase (I-IV). This project marks the final phase of the study     in which the investigators will conduct a pragmatic trial of the ePRO tool in 8-16 Family     Health Teams in Ontario through a stepped-wedge randomized trial with an embedded case study.     In this evaluation of the tool the investigators will assess outcome, process and context     measures to identify how the tool affects patients, providers and the system at     point-of-care.   "
254491|NCT02947152|"     A first-in-human study using HKT288 in solid tumors, including epithelial ovarian cancer and     renal cell carcinoma   "
254492|NCT02933541|"     Plan to monitor central arterial pressure in women who are undergoing spinal anesthesia for     cesarean delivery or epidural anesthesia for vaginal delivery.   "
254494|NCT02902172|"     Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and     deliver an infant via vaginal delivery will be placed into two groups in the postpartum     period. One group will receive Ibuprofen for pain control and the other group will be given     Tylenol. Blood pressures during the postpartum period will then be collected and compared in     order to see if NSAIDs use increases blood pressure.   "
254497|NCT02907723|"     This pilot study aims to assess a new device designed for an objective measure of sleep     parameters. The purpose of the device is to assess, in a more simple and precise way, the     impact of deep brain stimulation on patient's sleep.   "
254498|NCT02906670|"     This is the first study to test Sym013 (Pan-HER) in humans. The primary purpose of this study     is to see if Pan-HER is safe and effective for patients with advanced epithelial malignancies     without available therapeutic options.   "
254499|NCT02905435|"     This is a multi-center, single arm, traditional feasibility study to allow a preliminary     assessment of the safety and effectiveness of a new method of treating skin burns using     Biodegradable Temporizing Matrix (BTM).   "
254506|NCT02895958|"     Evaluation of Zepatier in a community-based setting among cirrhotic and non-cirrhotic     patients on stable opiate substitution therapy.   "
254507|NCT02893683|"     Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially memory     function.      Rothschild Foundation has developped the Paris Visual Learning and memory Test (PVLT). 165     healthy volunteers were studied for its normalization.      The main objective of the present study is to assess the validity of PVLT by comparing MS     patients' test results to a database including the test results of 280 healthy control     subjects, following recommended international standards.   "
254508|NCT02893800|"     The project aims to make new technologies for locating people with dementia easier to use for     the patients and those caring for them.      Objective: To systematically understand what improves the user experience of persons with     dementia (PwD) and their primary caregivers (CG) with locating system watches to ultimately     allow users to obtain more benefits from using these watches.      Aim: Improving the user experience of PwD and CG with locating system watches using a     cross-over design and a theory-based educational session approach.   "
254510|NCT02882204|"     The investigators propose to study the brain processes that result in thought and language     disorder and influence outcomes seen in patients with schizophrenia using a combination of     brain scans and clinical assessments. The project will assess patients at various stages of     psychosis (first episode and chronic stage >3 years of illness) referred to the Prevention     and Early Intervention in Psychosis Programme using Magnetic Resonance Imaging (MRI scans).     To track the outcome of this illness, investigators will follow-up patients over 3 years and     collect MRI scans over four sessions for each patient. Participants will also complete a     clinical assessment examining symptoms and functioning as per the current clinical practice     within the PEPP program.   "
254537|NCT02847286|"     A Study to assess the drug-drug interaction potential, between Dapivirine Vaginal Ring-004,     containing 25 MG of Dapivirine.   "
254538|NCT02862171|"     A follow-on, open label trial to assess continued safety of and adherence to the     Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women   "
254513|NCT02872792|"     Cycloergometer is a validated method for different care. This kind of device allow passive     and active care for patient. The interest of cycloergometer for patient hospitalized in     Intensive Care Unit for Sepsis has never been demonstrated.      The main objective of this study is to determine the impact of early mobilization by     cyclo-ergometer in association with standard physiotherapy, on the ICU length in patients     with septic shock      The secondary objectives of this study are to assess the impact of early mobilization by     cyclo-ergometer in association with standard physiotherapy on:        1. the duration between hemodynamic stability* and the removal of sedation        2. the duration between the removal of sedation and ICU discharge        3. the mechanical ventilation duration (invasive and noninvasive)   "
254515|NCT02875301|"     This randomized control trial will examine whether a 12 month monitored exercise intervention     improves brain health in cognitively normal older adults. This trial will also address     several important unanswered questions: (1) Are the recommended public health guidelines of     150 minutes/week of exercise sufficient for improving cognitive performance? (2) Does     exercise influence brain structure and/or function? (3) Is there a dose-response effect of     exercise on the above variables such that greater amounts of exercise brings about greater     benefits in cognitive and brain health? (4) What are the mechanisms by which exercise     influences brain health? and (5) What factors attenuate or magnify the effects of exercise on     brain and cognitive health and contribute to the individual variability in intervention     outcomes?   "
254516|NCT02873039|"     Over the past decade, advancements in therapies available for pulmonary hypertension (PH)     have increased life expectancy for those who qualify and receive treatment. Yet,     prognostication of these patients has remained a clinical dilemma. The application of the     REVEAL registry predictive algorithm provides information about estimated 1-year survival but     since invasive measurements from a right heart catheterization cannot easily be repeated, it     is not feasible to continually use this longitudinally to assess the disease burden. Simple     tests such as BNP has been shown to be very clinically relevant in short -term and long term     prognostication and seems to correspond well to the right ventricular failure. Elevated right     atrial pressures, and its estimation via IVC measurements predict poor survivorship in a     recent retrospective analysis. As clinical measurement of jugular venous pressure is becoming     less reliable, we aim to bring point- of-care ultrasound to the outpatient setting. Point of     care ultrasound is widely used in the Emergency Department and Intensive Care Unit settings.     By measuring estimated right atrial pressure (eRAP) via Inferior Vena Cava (IVC) measurements     at outpatient clinic visits we aim to find a correlation with the existing and widely used     B-type Natriuretic Peptide (BNP), that is collected at each visit as a part of regular care.     These measurements can be followed longitudinally and may aid in prognostication. Data will     be collected over the period of 1 year at clinic visits. A composite endpoint (including     death, hospitalizations for PH, addition of new PH specific therapy after a stabilization     period of 3 months, lung transplant or atrial septostomy) will separately be collected. At     the end of the data collection period, clinical data only will be collected for a additional     2 years via phone correspondence, chart review or at regular PH clinic visits.   "
254517|NCT02888067|"     The purpose of this study is to determine whether deep neuromuscular blockade provides better     surgical conditions than moderate neuromuscular blockade in patients undergoing vocal cord     resections requiring jet ventilation.   "
254518|NCT02880397|"     A single-center, randomized controlled clinical trial was done to assess the periodontal     status of the individuals and the presence of red complex microorganisms (RCM) such as     Treponema denticola, Porphyromonas.gingivalis and Tannerella.forsythia in the subgingival     tissues of periodontal pockets at baseline followed by the application of mangostana gel as     an adjunct to scaling and root planing. The periodontal parameters and RCM were again     assessed at 3rd month and compared with the placebo group.   "
254520|NCT02862535|"     The primary objective of this study is to characterize the safety and tolerability of     andecaliximab (GS-5745) as monotherapy and in combination with anti-cancer agents in Japanese     participants with inoperable advanced or recurrent gastric or recurrent gastroesophageal     junction (GEJ) adenocarcinoma.   "
254523|NCT02861053|"     The chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet     inflammatory bowel disease (IBD) and impacts the quality of life of the patients. The     beneficial role of a regular physical activity on the quality of life of patients having an     IBD was demonstrated in 5 studies including only 1 controlled one [Bilski, on 2013]. The     mechanism by which the physical activity could improve the quality of life of the patients     remains unknown (stress decreased, reduction of the inflammatory process) [Bilski, on 2014].     Several studies concerning other chronic pathologies such as fibromyalgia, have demonstrated     the beneficial effect of a regular physical exercise to reduce the fatigue of patients. It     was recently demonstrated that the chronic fatigue observed in patients with IBD came along     with a physical reduction in the performances during the exercise test and a reduction in the     physical activity of the patients [Vogelaar, 2015].      Our hypothesis is that a regular moderate physical activity could improve physical     performance during an effort et could reduce the chronic fatigue and improve their quality of     life.   "
254539|NCT02843230|"     This research study aims to predict treatment response to anti-angiogenic therapy (Avastin)     using advanced magnetic resonance imaging (MRI) and spectroscopy (MRS) for Glioblastoma     patients.   "
254524|NCT02858310|"     Background:      Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers     caused by HPV have a HPV protein called E7 inside of their cells. In this new therapy,     researchers take a person s blood, remove certain white blood cells, and insert genes that     make them to target cancer cells that have the E7 protein. The genetically changed cells,     called E7 TCR cells, are then given back to the person to fight the cancer. Researchers want     to see if this can help people.      Objective:      To determine a safe dose of E7 TCR cells and whether these cells can help patients.      Eligibility:      Adults ages 18 66 with an HPV-16-associated cancer, including cervical, vulvar, vaginal,     penile, anal, or oropharyngeal.      Design:      Participants will list all their medicines.      Participants will have many screening tests, including imaging procedures, heart and lung     tests, and lab tests. They will have a large catheter inserted into a vein.      Participants will have leukapheresis. Blood will be removed through a needle in the arm. A     machine separates the white blood cells. The rest of the blood is returned through a needle     in the other arm.      The cells will be changed in the lab.      Participants will stay in the hospital. Over several days, they will get:      Chemotherapy drugs      E7 TCR cells      Cell growth factor      Shots or injections to stimulate blood cells      Participants will be monitored in the hospital up to 12 days. They will get support medicine     and have blood and lab tests.      Participants will have a clinic visit about 40 days after cell infusion. They will have a     physical exam, blood work, scans, and maybe x-rays.      Participants will have many follow-up visits with the same procedures. At some visits, they     may undergo leukapheresis.      Participants will be followed for 15 years.   "
254526|NCT03268083|"     The objectives of this study are to evaluate the immune response and safety profiles of two     injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg     dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.   "
254527|NCT02863445|"     Obese women are significantly more likely than their normal BMI counterparts to experience     failure of orally-dosed emergency contraceptives. The PI's preliminary data provides evidence     for testing a dose escalation strategy in an effort to provide improved efficacy from     orally-dosed emergency contraceptives in obese women. The overall project will be focused on     both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but     this protocol registration is for the LNG aspect of the study procedures.   "
254528|NCT02859337|"     Obese women are significantly more likely than their normal BMI counterparts to experience     failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for     testing a dose escalation strategy in an effort to provide improved efficacy from     orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency     contraception containing ulipristal acetate. The overall project will be focused on both     levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but     this protocol registration is for the UPA aspect of the study procedures.   "
254531|NCT02857764|"     The purpose of the study is to estimate the incidence of below-knee lower extremity     amputation in type 2 diabetes mellitus (T2DM) participants newly exposed to sodium-glucose     co-transporter 2 inhibitors (SGLT2i)/ non-SGLT2i antihyperglycemic agents (AHA) overall and     in the subgroup with high cardiovascular (CV) risk and to compare the hazards of below-knee     lower extremity amputation in canagliflozin new users versus non-SGLT2i AHA new users.   "
254541|NCT02845271|"     Primary Objective:      To assess the efficacy of a single intraarticular dose of GZ389988 compared to placebo for     relief of knee pain in patients with osteoarthritis (OA) of the knee.      Secondary Objectives:      To assess the safety and tolerability of a single intraarticular dose of GZ389988 in patients     with painful OA of the knee.      To assess the pharmacokinetic parameters of a single intraarticular dose of GZ389988 in     patients with painful OA of the knee.   "
254542|NCT02846792|"     This phase I/II trial studies the side effects and best dose of plinabulin when given     together with nivolumab and to see how well they work in treating patients with stage IIIB-IV     non-small cell lung cancer that has come back or spread to other places in the body.     Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to     grow and spread. Drugs used in chemotherapy, such as plinabulin, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Giving nivolumab and plinabulin together may work better     at treating patients with non-small cell lung cancer.   "
254543|NCT02845947|"     This study seeks to research the effects of music therapy during pediatric extubation     readiness trials. Amount of sedation, physiological measures, and parent/staff satisfaction     surveys will be measured.   "
254544|NCT02846571|"     The treatment in this trial consists of intraocular islet transplantation. A single dose of     1000 - 2000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the     anterior chamber of the eye through a self-sealing incision of the peripheral cornea. The     procedure is projected to take approximately 20-30 minutes. Subject will remain flat on their     back for 45-60 minutes after islet infusion to maximize adhesion of the islets to the iris.   "
254545|NCT02858037|"     HIV Open-label Prevention Extension (HOPE).   "
254548|NCT02861365|"     This is a study of the perfusion of the myocardium in adults with specific forms of repaired     congenital heart disease using established cardiac MRI techniques and correlating perfusion     with clinical outcomes.   "
254549|NCT02833402|"     Sacral neuromodulation (SNM) which is approved as a treatment for men and women with urgency     urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal     incontinence, is a procedure designed to deliver electrical pulses to the sacral nerves,     thereby influencing the bladder, sphincters, and pelvic floor. Although the success rates of     this treatment are quite high, the precise mechanism of action of SNM in subjects with UUI     remains unclear. Moreover, there are little data regarding specific patient characteristics     that may serve as predictors for SNM success. Recent studies suggest that the bacterial     community that lives in the urinary tract plays a role in the development and continuation of     urinary symptoms. It is proposed that the urinary microbiome may change in women before and     after SNM implantation and this study aims to describe these changes. Investigators in this     study also hope to determine if differences in the urinary microbiome exist in women with a     positive response to SNM treatment (responders) compared to those without symptom improvement     (non-responders). This hypothesis will be tested by collecting urine samples as well as     questionnaire and medical data from subjects with UUI that are already planning on undergoing     SNM as part of clinical care before and after their SNM treatment.   "
254550|NCT02831686|"     The purpose of this study is to test the safety of a combination of study drugs called     selinexor (KPT-330) and ixazomib (MLN9708) with a low dose of dexamethasone. This study tests     different doses of the study drug, selinexor to see which dose is safer in people. Depending     on which group (dose level) you are in, the dose of selinexor will vary, but the ixazomib and     dexamethasone doses will be the same among the groups.   "
254552|NCT02892903|"     A randomised controlled trial to compare two strategies for the investigation of coronary     artery disease at the time of angiography. Patients will be randomised to conventional     angiography or additional, routine pressure wire assessment - measuring fractional flow     reserve (FFR) - in all main vessels judged as being of sufficient vessel calibre to allow     percutaneous coronary intervention (PCI) (experimental arm).   "
254554|NCT02964481|"     The purpose of this study is to to determine the penetrance of known and probable pathogenic     variants in genes and the factors that contribute to penetrance in a population of children     and adults in the United States exposed to Malignant Hyperthermia (MH) trigger agents.   "
254555|NCT02863393|"     The non-alcoholic fatty liver disease is increasing and associated with obesity, diabetes and     hyperlipidemia in recent years. Aerobic exercise indeed reduces adipose, hepatic insulin     resistance and hepatic fat. However, diaphragmatic breathing improves cardiopulmonary     function, the oxygen content of the body and therefore reduces inflammation of cells. The aim     of this study is to ameliorate hepatic inflammation by using diaphragmatic breathing     exercises instead of aerobic exercise to reduce the fat in liver inflammation.   "
254556|NCT02872259|"     The purpose of the study is to assess the safety and efficacy of BGB324 given together with     standard treatment, pembrolizumab or dabrafenib and trametinib, compared to standard     treatment alone,   "
254557|NCT02812901|"     This study aims to understand the impact of time-of-the day on human myocardial tolerance to     ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery. Patients     scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or aortic valve     replacement) will be assigned to a morning or an afternoon cardiac surgery based on     randomization. Myocardial biopsies will be explored in ex vivo conditions mimicking     ischemia-reperfusion.   "
254558|NCT02848001|"     CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects     with relapsed or refractory acute myeloid leukemia   "
254560|NCT02855346|"     PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel   "
254561|NCT02818036|"     The purpose of the study is to explore the effect of blocking opioids on affiliation-related     neural activity.   "
254563|NCT02960997|"     Epidermolysis bullosa (EB) simplex is a rare orphan disease caused by a mutation in DNA     leading to abnormal dominant keratins in the skin. Patients with EB simplex develop lifelong     painful thick soles on their feet, and current standard of care is supportive. This pilot     study will target the dominant mutant keratin proteins in the skin to ameliorate the severity     of EB simplex. The purpose is to improve the function of EB simplex feet with an application     of topical sirolimus, 2%. The investigators plan on inhibiting the mTOR pathway to down     regulate the translation of defective keratin proteins and work through anti proliferative     pathways.   "
254573|NCT02799238|"     This is a randomised, open-label, multi-centre, Phase II study in patients with newly     diagnosed glioblastoma.      Up to 87 patients with newly diagnosed glioblastoma will be enrolled in the study in a 1:2     allocation (standard of care (SOC): ALECSAT as an adjunct therapy to SOC).      Data from a further 29 patients gathered from an ongoing observational study of glioblastoma     patients treated according to SOC at Sahlgrenska University hospital in Göteborg, Sweden will     be used as historical control data and combined with the randomised control data in     performing the statistical analysis.      Patients recruited into this study will receive either:        -  ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma          (first line therapy: Stupp regimen, followed by second line therapy at the          Investigator's discretion) or        -  Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp          regimen, followed by second line therapy at the Investigator's discretion).   "
254564|NCT02811029|"     A total of 40% of neurodevelopmental difficulties have been reported in very premature     infants less than 32 weeks of age. The Epipage1 study reported a decreasing prevalence of     cerebral palsy (9-6%) but a high prevalence of specific cognitive neurological difficulties     and an increase in school failure.      Neurocognitive difficulties are numerous: visuospatial dyspraxia, language disorders,     executive function disorders as well as attention and behaviour disorders. Developmental     language disorders have been rarely reported in the literature. This originally prompted our     request i.e. PHRC 2010 National Multicenter: LAMOPRESCO. For the past 3 years this protocol     has studied the language development of children who were born very prematurely, aged 3 and a     half years free of cerebral palsy, in particular the impact of a short rehabilitation period,     precise, at an early stage, and protocolized on a fundamental sensorimotor language. The     principal assessment criterion was the measurement of phonology, the cornerstone of oral and     written language in humans. The aim of the present project is an analysis of the effect that     this specific language stimulation has on the learning of written language. The hypothesis is     that a specific work modifying various aspects of a child's language, during the age of 3 to     4, alters the development of phonological skills in a sustainable way. The acquisition of     reading skills is basically dependent on the quality of its phonological components. The     randomized study of children up to 8 years of age in a cohort of 150 children (LAMOPRESCO)     will permit to confirm or refute this hypothesis. These increasing difficulties have been     reported as regards the language understanding of 3 to 15 year old children. It is as if the     initial difficulties and weaknesses, which moreover constituted oral language, prevented the     use or development of neural networks, which became more complex and required both an oral     and written language. Are these elements which constitute phonology, at an early stage,     modifiable before the close of the clinically measurable developmental window?   "
254565|NCT02833961|"     Cerebral vascular disorder is one of the most fatal diseases despite current advances in     medical science. The large number of negative clinical trials on neuroprotection in acute     stroke is a pointer to the fact that translating better understanding of the pathogenesis and     pathophysiology to clearly beneficial treatment strategies remains a daunting task. This     project aims at elucidating the plausible biophysical events that affect water and metabolite     diffusion in brain tissue after ischemia, by combining the information provided by two     advanced methods of magnetic resonance (MR) diffusion imaging: diffusional kurtosis imaging     and diffusion-weighted spectroscopy.      Diffusion weighted imaging (DWI) has been established as a major tool for the early detection     of stroke. However, information obtained using conventional DWI may be incomplete.     Diffusional kurtosis (K) is a quantitative measure of the complexity or heterogeneity of the     microenvironment in white and grey matter, which offers complementary information and may     potentially be a more sensitive biomarker for probing pathophysiological changes. In     addition, to gain more specific insights into molecular mobility in the intracellular     environment, it is beneficial to assess the diffusion properties of metabolites, such as     N-acetylaspartate (NAA), creatine and phosphocreatine (Cr), and choline containing compounds     (Cho). Assessment of metabolite diffusion changes by diffusion-weighted spectroscopy (DWS)     provides information specific to the intracellular environment. In particular, thanks to the     specific compartmentation of NAA almost exclusively in neurons and of Cho in glial cells, the     diffusion properties of these metabolites may provide specific insights into the pathological     processes occurring independently in the two cell types. In addition, measuring a temporal     profile of diffusion coefficient of these compounds may help clarify underlying     pathophysiological changes in neuronal cells during acute ischemia.      With the help of these two advanced methods, a proof-of-concept trial is proposed on 24     healthy subjects and 24 ischemic stroke patients. Ischemic stroke patients will be scanned     three times with a 3T MR scanner (before day 10 post-stroke, around week 4 and 3 months), in     order to extract diffusion kurtosis imaging (DKI) and DWS metrics and understand the dynamics     of the cellular mechanisms at play in cerebral ischemia. The goal of this study is to     investigate neuronal and glial metabolite diffusion changes at different time points after     ischemic stroke, in both infarcted and non-infarcted hemispheres. The aim is to get     non-invasively important information on the evolution of the cellular damage in this disease,     and possibly distinguishing between neuronal and glial processes (by measuring the metrics     extracted for these two sequences), as well as on the different mechanisms leading to     metabolite diffusion changes in the two brain areas, thus providing a great impact on the     strategy of treatment for patients with cerebral infarction.   "
254569|NCT02805660|"     Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a     human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or     PD-L1). Durvalumab is also known as a checkpoint inhibitor.      This study is evaluating the combination regimen of mocetinostat and durvalumab in subjects     with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.      Patients eligible for this study may have previously received treatment with a checkpoint     inhibitor.   "
254570|NCT02806947|"     The study is a Phase II randomized, open label, multicenter trial designed to identify     whether sirolimus is a potential alternative to prednisone as an up-front treatment for     patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk     stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus) as     well as a novel BMT CTN developed acute GVHD biomarker test.   "
254571|NCT02820740|"     Multicenter, open-label, prospective designed study to characterize the performance of brain     laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System for     the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates     for LITT surgery.   "
254575|NCT02796391|"     STUDY 1: INTERVENTION DEVELOPMENT The purpose of this study is to determine the best way to     help people stop smoking by using very low nicotine content (VLNC) cigarettes. These study     cigarettes are made from genetically modified (GMO) tobacco plants. This developmental pilot     study (n=20) will determine the feasibility of the treatment approach and methodology, and     lead to refinements for a subsequent randomized controlled trial (RCT).      STUDY 2: RANDOMIZED CONTROLLED TRIAL The purpose of this study is to see if targeted     interventions will help people to stop or reduce smoking better than standard interventions     using very low nicotine content (VLNC) cigarettes. The low-nicotine tobacco in the study     cigarettes is obtained from genetically modified (GMO) tobacco plants. About 220 participants     will take part in this phase of the study at Moffitt Cancer Center.   "
254592|NCT02788851|"     The purpose of this project is to evaluate the effectiveness of a structured aerobic exercise     intervention for adults with Attention-Deficit/Hyperactivity Disorder (ADHD) with and without     medication and compare it to medication alone. Participants will be randomly assigned to     medication only + education, aerobic exercise intervention only, and combined aerobic     exercise and medication groups. Participants will be evaluated at baseline, following     medication optimization (for medicated groups), following 8 weeks of intervention, after 3     months of follow-up, and after 6 months of follow-up. The investigators hypothesize that the     combined group will have the best outcome at all evaluation points and that treatment gains     will be maintained throughout the follow-up period if the assigned treatments are continued.   "
254578|NCT02790775|"     In this double blind clinical trial, 1000 patients suffering from diabetic macular edema,     age-related macular degeneration, neovascularization due to proliferative diabetic     retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included.     Those with the history of Ocular pain prior to the procedure, any contraindication for     Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions     that could affect pain sensation, history of using systemic analgesic or sedative     medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and     bullous keratopathy and poor cooperation in using the visual analogue scale (VAS) are     excluded from the study. Before starting the treatment all patients undergo complete     ophthalmic exam , best-corrected visual acuity (BCVA) checking and macular thickness     measurements using optical coherence tomography (OCT). Patients are randomly assigned to each     group .Each participant receive one injection in one eye in this study. Pain is measured by     subjective grading on a Visual Analog Scale (VAS) immediately after IVI. BCVA and OCT would     be checked again at month one.   "
254580|NCT02794012|"     The purpose of this study is to evaluate the association of Rheumatoid Arthritis (RA)-related     antibodies and periodontal inflammation in subjects at-risk for Rheumatoid Arthritis.     Subjects will undergo periodontal and joint examinations, as well as collection of body     fluids to measure Rheumatoid Arthritis-related antibodies.   "
254581|NCT02798276|"     The purpose of this trial is to evaluate the efficacy of a pericardial adipose graft     transposition (Adipose Graft Trasposition Procedure, AGTP) for the improvement of cardiac     function in patients with a chronic myocardial infarction. Preclinical studies in the porcine     model of myocardial infarction have shown that the AGTP reduces infarct area and improves     cardiac function. A first-in-man clinical (NCT01473433) trial showed that the AGTP is safe in     patients.   "
254582|NCT02798354|"     The proposal will focus on 3 specific, high-risk, pediatric ambulatory diagnostic errors each     representing a unique dimension of diagnostic assessment: evaluation of symptoms, evaluation     of signs and follow-up of diagnostic tests. Adolescent depression (i.e. symptoms) affects     nearly 10% of teenagers, is misdiagnosed in almost 75% of adolescents and causes significant     morbidity. Pediatric elevated blood pressure (signs) is misdiagnosed in 74-87% of patients,     often due to inaccurate application of blood pressure parameters that change based on age,     gender and height. Actionable pediatric laboratory values (diagnostic tests) are potentially     delayed up to 26% of the time in preliminary investigations and 7-65% in adults, leading to     harm and malpractice claims.      The investigators propose to conduct a multisite, prospective, stepped wedge cluster     randomized trial testing a quality improvement collaborative (QIC) intervention within the     American Academy of Pediatrics' Quality Improvement Innovation Networks (QuIIN) to reduce the     incidence of pediatric primary care diagnostic errors. QuIIN is a national network of over     300 primary care practices, ranging from tertiary care academic medical centers to single     practitioner private practices, interested in and experienced with QICs. Because many     processes are likely to be common across diagnostic errors in outpatient settings, a     multifaceted intervention, such as a QIC, has a high likelihood of success and broad     applicability across populations. Preparatory inquiries to QuIIN primary care providers     suggest high interest in reducing these 3 diagnostic errors and provider agreement with     randomization to evaluate diagnostic error interventions. Practices will be randomized to one     of three groups, with each group collecting retrospective baseline data on one error above,     and then intervening to reduce that error during the first eight months. Each group will     concurrently collect control data on an error they are not intervening on during those eight     months. Following those eight months, the groups will continue intervening on their first     error, begin intervening on the error they were a control site for, and begin collecting data     on the third error for which they will be a control site for. Finally, in the final eight     months, all groups will intervene on all three errors. A second wave of practices will be     recruited to join the groups after eight months and will only intervene on two of the three     errors.   "
254584|NCT02797964|"     The study drug, SRA737, is a highly selective, orally bioavailable small molecule inhibitor     of checkpoint kinase 1 (Chk1). Chk1 is a serine-threonine kinase which acts as a central     regulator of the DNA Damage Response (DDR) network. The DDR network is a complex series of     pathways which detect DNA damage, pause the cell cycle, and repair damaged DNA. Chk1     regulates multiple cell-cycles phases, temporarily pausing the progression of cell     replication and division allowing DNA repair processes to be undertaken. In addition, Chk1     directly activates several important downstream DDR proteins involved in the repair of     damaged DNA.      The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of     SRA737, to assess its preliminary safety and activity, and to propose a recommended dose for     subsequent clinical studies.      To determine potential selection strategies for further clinical development, the study will     also evaluate the preliminary efficacy of SRA737 in prospectively-selected subjects with     tumors identified to have genetic aberrations hypothesized to confer sensitivity to Chk1     inhibition. Specific cancer indications that frequently harbor these genetic mutations will     be studied.   "
254585|NCT02786901|"     Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of     Ocular Inflammation and Pain Following Cataract Surgery.   "
254588|NCT02780479|"     Asthma is the most common chronic disease of children. A short (3-5 day) course of a     short-acting steroid such as Prednisone or Prednisolone has long been the standard of care     for asthma exacerbation. Dexamethasone efficacy in asthma exacerbation has been studied in     the outpatient setting and was found to be as effective as Prednisone. Dexamethasone has the     advantage of shorter course, more compliance, and more tolerable. This has led many emergency     departments to provide a 1-2 dose course of Dexamethasone on discharge. Thus, many inpatients     have received a first dose of Dexamethasone prior to reaching the inpatient unit, leading to     confusion about the best plan for these patients. Many hospitalist pediatricians continue to     give a 5-day total course with Prednisone, but some patients have begun to receive a second     dose of Dexamethasone 24 hours after the first dose. To our knowledge, no studies have been     done to compare the efficacy of these two protocols in pediatric patients requiring     hospitalization. The hypothesis is that a second dose of Dexamethasone is as effective as     four additional days of Prednisone in hospitalized children with asthma exacerbation. This is     an open label, randomized control study comparing these treatments in children age 2-18     hospitalized with asthma exacerbation who have received a first dose of Dexamethasone.   "
254589|NCT02776670|"     The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE     compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.   "
254590|NCT02775435|"     This is a study of carboplatin and paclitaxel or nano particle albumin-bound paclitaxel     (nab-paclitaxel) with or without pembrolizumab (MK-3475, KEYTRUDA®) in adults with first line     metastatic squamous non-small cell lung cancer (NSCLC).      The primary hypotheses are that treatment with pembrolizumab prolongs: 1) Progression-free     Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as     assessed by a blinded central imaging vendor compared to placebo, and 2) Overall Survival     (OS).   "
254750|NCT02468817|"     Exercise that causes a decline in serum Calcium (Ca) as a result of dermal Ca loss stimulates     bone resorption via an increase in Parathyroid Hormone (PTH).   "
254593|NCT02773758|"     This will be a single centre, two week, randomised, examiner blind, two treatment arm,     parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected     test teeth), controlled study, in participant with at least two sensitive teeth that meet the     study criteria at the Screening and Baseline visits. The study will be conducted in     participants in good general health, with pre-existing self-reported and clinically diagnosed     tooth sensitivity at screening.   "
254594|NCT02769845|"     Prospective screening and treatment study for children with Sickle Cell Anemia and increased     stroke risk living in the Dominican Republic.   "
254595|NCT02772276|"     This study is a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the use     of the non-invasive optical renal function monitor (ORFM) device in normal and compromised     renal function participants with different skin color types.   "
254596|NCT02774421|"     This study plans to detect the presence of trastuzumab by mass spectroscopy in relapsed     posterior fossa ependymoma (PFEPN) tumor specimen pre-treated with a single dose of     intrathecal (IT) trastuzumab, as well as to evaluate toxicity of intrathecal trastuzumab in     combination with subcutaneous (subQ) Granulocyte-macrophage colony-stimulating factor     (GM-CSF) in children with relapsed PFEPN   "
254597|NCT02768363|"     The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in     patients undergoing active surveillance for localized prostate cancer. ProstAtak® involves     the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate a cancer     vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's     immune system to detect and destroy cancer cells. ProstAtak® has been well tolerated in     previous trials in patients with prostate cancer and other tumor types. Biochemical,     pathologic and immune responses have been demonstrated in newly diagnosed and recurrent     prostate cancer. The hypothesis is that ProstAtak can lead to improvement in the clinical     outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak®     or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance     evaluations.   "
254598|NCT02766465|"     This is a clinical trial that will compare survival and sickle related outcomes in     adolescents and young adults with severe sickle cell disease after bone marrow     transplantation and standard of care. The primary outcome is 2-year overall survival.   "
254603|NCT02761161|"     The overall aim of this study is to examine the effects of sleep enhancing treatment in     refugees with PTSD.   "
254609|NCT02745756|"     This study adds an experimental treatment with another type of cells, called dendritic cells.     It is hoped that these cells may stimulate the immune system to react against neuroblastoma     in much the same way that vaccines cause the immune system to react to certain viruses and     bacteria. The physicians conducting this study have observed from previous research that     neuroblastoma cells can be recognized by the immune system, and that they can be destroyed by     immune cells.The main goal of this study is to see if giving participants this additional     anti-Neuroblastoma vaccine reduces the risk of relapse following the Hematopoietic Stem Cell     Transplant.   "
254610|NCT02760797|"     This is an open-label, multicenter study designed to assess the safety, pharmacokinetics,     pharmacodynamics, and therapeutic activity of emactuzumab and RO7009789 administered in     combination in participants with locally advanced or metastatic solid tumors that are not     amenable to standard treatment. This study will be conducted in two parts: a dose-finding     stage (Part I) and an expansion stage (Part II).   "
254611|NCT02754362|"     This is a phase II study to determine the immunogenicity and efficacy of a vaccine composed     of tumor associated long synthetic peptides mixed with Montanide ISA-51 VG administered with     polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (Poly-ICLC) and     bevacizumab in adults with recurrent glioblastoma.   "
254612|NCT02739360|"     This study is to provide idelalisib to participants receiving GS-9820 in Gilead-sponsored     Study GS-US-315-0102 at the time of study closure.   "
254613|NCT02738879|"     This is a trial of continuing sitagliptin versus withdrawing sitagliptin in participants with     Type 2 diabetes mellitus (T2DM) and inadequate glycemic control who initiate and titrate     insulin glargine (LANTUS®) based on a treat-to-target algorithm to achieve fasting glucose     levels of 72-100 mg/dL (4-5.6 mmol/L). A primary hypothesis of this trial is that after 30     weeks, continuing sitagliptin results in a greater reduction of hemoglobin A1C (A1C) relative     to withdrawing sitagliptin.   "
254615|NCT02733042|"     This open-label, multicenter, global study is designed to determine the recommended phase 2     dose, safety, efficacy, and pharmacokinetics/pharmacodynamics of durvalumab in subjects with     certain lymphoma subtypes or CLL. Globally, 265 subjects may be enrolled into 4 treatment     arms, including durvalumab monotherapy; durvalumab in combination with lenalidomide±     rituximab; ibrutinib; or rituximab ± bendamustine. The study will have 3 parts: dose finding,     dose confirmation, and dose expansion. Subjects receiving monotherapy may receive combination     therapy or involved-field radiation to a single nodal site at time of progressive disease.   "
254621|NCT02729961|"     This phase I/II trial studies the side effects and best dose of ceritinib when given together     with brentuximab vedotin to see how well they work in treating treatment-naive patients with     anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma. Ceritinib may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as brentuximab vedotin, may interfere with the ability of tumor cells to     grow and spread. Giving ceritinib together with brentuximab vedotin may be a better treatment     for ALK-positive anaplastic large cell lymphoma.   "
254622|NCT02726386|"     This is a multi-center, international, open-label, safety study of ND0612, a solution of     levodopa/carbidopa (LD/CD) delivered via a pump system as a continuous SC infusion in     subjects with advanced Parkinson's Disease.   "
254626|NCT02715466|"     This prospective, double-blind randomized controlled trial evaluates the differences in terms     of efficacy and safety of gelatin based resuscitation as compared to crystalloid based     resuscitation in two parallel groups of patients with severe sepsis / septic shock.   "
254838|NCT02276482|"     The purpose of the study is to compare the safety of intravenous (IV) and/or oral 6-day 200     mg tedizolid phosphate with 10-day comparator in participants 12 to <18 years with cSSTI.   "
254627|NCT02731027|"     The purpose of the study is to profile biochemical responses and measure functional recovery     in parallel, throughout the 1st year after spinal cord injury (SCI), within the same     participants. These responses and recovery will be evaluated in samples from people who have     had a spinal cord injury due to trauma (e.g. car accident or a fall) within the first year     after SCI. Specifically, the investigators will test the hypothesis that a subset of     inflammatory biomarkers correlate inversely with functional recovery. The investigators will     use these data to build a predictive model of functional recovery after SCI that incorporates     biomarkers that can be easily quantified in the clinic.      Total anticipated enrollment will be 100 participants with SCI across three different sites     (Northwell Health System (NY), The Kessler Institute for Rehabilitation (NJ), University of     Louisville (KY) and may enroll up to 30 participants without SCI.   "
254628|NCT02717598|"     Background:The optimal technique for removal of diminutive or small colorectal polyps is     debatable.      Objective:To compare the complete resection rates of cold snare polypectomy (CSP) and hot     snare polypectomy (HSP) for the removal of adenomatous polyps(3-9mm).      Design：Prospective randomized controlled study. Setting：Three tertiary referral hospitals.     Patients：we will recruit a total of 330 polyps(3-9mm). Interventions:Enrolled patients were     randomly assigned to one of the two polypectomy protocols (CSP vs. HSP) using a     computer-generated random sequence. If a patient had one or more polyps, all eligible polyps     were removed using the initially assigned polypectomy protocol. After the initial     polypectomy, additional EMR was performed at the polypectomy site to assess the presence of     residual polyp tissue.      Main Outcome Measurements:The primary study outcome was to compare the complete polyp     resection rate between groups. Secondary outcomes included rate of postpolypectomy adverse     events, including bleeding, perforations,infection and rate of tissue retrieval(Complete     resection was defined as the absence of residual polyp tissue in the EMR sections of the     polypectomy site).   "
254629|NCT02726360|"     The purpose of this study is to test a method for analyzing interactions between patients and     doctors, the Roter Interaction Analysis System (RIAS).   "
254633|NCT02703922|"     Giant cell arteritis (GCA or temporal arteritis or cranial arteritis) or Horton disease is a     vasculitis that occurs in older adults, affecting vessels of medium and large caliber. The     diagnosis of GCA is a challenge for general practitioners and specialists. Since 1970, it is     based on a combination of clinical, biological and histological signs. Temporal artery biopsy     (TAB) was the reference method until recently. However, TAB has many drawbacks. Therefore,     researches of the past 20 years have been intended to develop alternative diagnostic methods.     This was notably the case of the color Doppler ultrasound (CDU) since the description by     Wolfgang Schmidt of the halo sign. Although European and British recommendations put CDU as     second line method, many authors suggest the possibility to do without TAB in many cases. In     addition, many practitioners believe that it is not ethical to use an invasive unprofitable     procedure like TAB, and have already been using CDU in their routine practice. However, no     diagnostic algorithm validating this approach in a prospective series has been published to     date. Therefore, the present study aim at validating a diagnostic algorithm of giant cell     arteritis using color Doppler imaging of temporal arteries and cervicocephalic axes as first     screening method.   "
254634|NCT02705651|"     A.Background      More than 90% of patients with multiple endocrine neoplasia type 1 (MEN1) develop multiple     pancreatic neuroendocrine tumors (pNETs). These tumors are the most common cause for     premature death in MEN1.      While functioning pNETs must be treated to reduce or cure hormonal excess, the procedures for     non-functioning pNETs are yet under discussion. Treatment ranges from watchful waiting to     subtotal and total pancreatectomy. The latter may represent an overtreatment, resulting in     general complications and diabetic metabolic status.      The effect of somatostatin analogues (SAs) has shown promising results with regard to     progression of non-functioning duodeno-pancreatic NETs. Treatment with SAs is highly safe and     effective, resulting in long-time suppression of tumor growth.      B. Aim      In this study of MEN1 patients with non-functioning pNETs, the benefits of somatostatin     analogs (SAs; group 1) compared to no treatment (group 2) will be analyzed with regard to     progression (tumor growth; development of new [functioning and non-functioning]     neuroendocrine tumors and regional/distant metastasis).      C. Implementation      Patients will either receive Somatostatin Analogs (SAs) or no treatment. The observation     period will be 60 months. The increase of tumor size and development of new tumors or     metastasis will be monitored.   "
254635|NCT02715271|"     The correlation of the morphologic, microbiological, genetic and histopathological     characteristics of TB lesions obtained in therapeutical surgery with the clinical forms and     features of the patients will provide essential information        1. on the role of the host in the mechanisms associated to the generation and evolution of          active TB and        2. about future diagnostic and/or prognostic biomarkers of TB disease. All this information          could be used for patients stratification and/or to design new therapeutic strategies.   "
254640|NCT02684617|"     This is a non-randomized, open-label study evaluating the safety and efficacy of     pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of     relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or     diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.      During an initial Dose Evaluation phase (first 2 cycles) to determine Dose Limiting     Toxicities (DLTs), dose combinations of pembrolizumab 200 mg followed by dinaciclib 7 mg/m^2,     pembrolizumab 200 mg followed by dinaciclib 10 mg/m^2, and pembrolizumab 200 mg followed by     dinaciclib 14 mg/m^2 will be evaluated. Following safety review of the Dose Evaluation Phase,     approximately 30 participants each will be enrolled in rrCLL, rrMM, or DLBCL cohorts during     the Signal Detection phase. For each disease type objective response rate (ORR) will be     determined by disease specific criteria.   "
254988|NCT01656187|"     The purpose of the study is to determine if an investigational drug called memantine,used     here as add-on therapy, is associated with improvements in memory, mood and asthma symptoms.     We will also examine changes in the brain by taking images or pictures using an MRI/MRS.   "
254832|NCT02337361|"     An innovative, self-administered computerized screening and brief intervention (SBI) for     drinking during pregnancy will be adapted for use with non-pregnant childbearing age women     and its efficacy will be tested in a small trial. Study findings will inform a larger     randomized control trial for a primary prevention tool with the potential for broad health     impact.   "
254643|NCT02678117|"     This study evaluates the effect of giving preoperative adjuvant drug as pregabalin or     magnesium sulphate or a combination of both drugs to decrease postoperative morphine     consumption and pain intensity in the first 24 hours in postoperative period . quarter of     patients receive single dose oral pregabalin 300mg 1 hour preoperatively ,other quarter     receive single intravenous Magnesium sulphate 50mg per Kg over 200ml saline over 20 minutes     preoperatively , other quarter receive combination of both drugs , the last quarter receive     placebo drugs . All patients receive 0.1mg per Kg intravenous morphine sulphate     intraoperatively   "
254644|NCT02682316|"     The purpose of this study is to compare any good and bad effects of using the Prevena     Incision Management System to using the usual standard dry gauze approach. The Prevena     Incision Management System is a type of Negative Pressure Wound Therapy (NPWT). NPWT is a     portable vacuum device made of a sponge-like foam that is applied over your incision to help     draw fluid and debris out after surgery.   "
254647|NCT02676986|"     This study is being carried out to see if the antiandrogen enzalutamide has antitumour     effects in early breast cancer.      Enzalutamide blocks the action of androgens on the androgen receptor (AR) and may slow down     or stop breast cancers growing. Enzalutamide is approved for the treatment of prostate     cancer.      The trial will be offered to patients who have just been diagnosed with early breast cancer     and who are planned to have surgery in the next few weeks. The treatment will bridge the time     between the diagnosis and surgery and will be given for 2- 4 weeks. To assess the effect of     the treatment, small samples of breast cancer tissue will be analysed before the start and     after treatment. The pre-treatment assessment will be done on archived tissue but patients     might require an additional biopsy, if sufficient stored tumour tissue is not available. The     end of treatment samples will be taken during surgery, unless the patient will receive     medical treatment first instead of surgery which might mean additional biopsies of the breast     cancer have to be taken. The trial has two cohorts. The cohort of patients with oestrogen     receptor (ER) positive breast cancer will test if adding enzalutamide to exemestane is better     at slowing the growth of breast cancer than exemestane alone. This cohort will recruit 141     evaluable post-menopausal patients with a tumour size of at least 1 cm. The aromatase     inhibitor exemestane is approved for the treatment of ER positive breast cancer. Blocking     aromatase decreases oestrogens but can increase androgens. Enzalutamide is therefore added to     block the action of androgens on the AR.      In the second cohort of patients with triple negative breast cancer (TNBC), enzalutamide will     be given alone to see if it can slow the growth tumours with androgen receptors. As only     approximately 30% of TNBCs express the AR, a pre screening step will be included to test the     tumour AR expression, before patients are approached for the ARB trial. The TNBC cohort will     comprise 55 patients.   "
254648|NCT02673333|"     Pembrolizumab is a type of immunotherapy, and the purpose of this study is to find out what     effects, good and/or bad, pembrolizumab has on you, and your cancer.   "
254651|NCT02674204|"     The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on     changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce     or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast     cancer patients.   "
254653|NCT02662309|"     ABACUS is an open-label, international, multi-centre, window of opportunity phase II trial     for patients with histologically confirmed (T2-T4a) transitional cell carcinoma of the     bladder. The trial aims to test the efficacy of preoperative MPDL3280A and will include     extensive biomarker work on samples from these patients. Eligible patients will receive two     3-weekly cycles of MPDL3280A pre-cystectomy. Following cystectomy, patients will be followed     up for safety, survival, and disease data.   "
254655|NCT02653092|"     Obesity plays an adverse role at every stage of conception and pregnancy and mounting     evidence implicates relative hypogonadotropic hypogonadism, and reduced menstrual cycle     hormone secretion as likely contributors to the subfertility phenotype and possible     contributors to complications of pregnancy and the developmental origin of adult diseases     such as diabetes and cardiovascular disease. This study will be the first comprehensive     investigation to tie together the patterns of hyperinsulinemia, hyperlipidemia and     inflammation, characteristic of obesity and obesity-caused relative hypogonadotropic     hypogonadotropism and its potential adverse reproductive outcomes. The investigators findings     will be used to inform a subsequent clinical intervention to optimize reproductive outcomes     for obese women and their offspring.   "
254656|NCT02648724|"     This is the first study to test Sym015 in humans. The primary purpose of this study is to see     if Sym015 is safe and effective for patients with advanced solid tumors who do not have other     available or accessible treatment options.   "
254657|NCT02647437|"     Levetiracetam (LEV: (S)-α-ethyl-2-oxo-pyrrolidine acetamide) is an     anticonvulsant/antiepileptic drug. The specific aim of this study is to assess the efficacy     of low-dose LEV in reducing hippocampal activity in schizophrenia. The investigators also     hypothesize that LEV will improve neurocognition in patients with schizophrenia.   "
254664|NCT02808949|"     Phase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women.   "
254667|NCT02635568|"     Legalization of marijuana in Colorado for both medicinal and recreational purposes has led to     a perception of its safety, which has not been well studied in pregnant or lactating women.     The psychoactive component of marijuana, delta-9-tetrahydrocannabinol (THC) is lipophilic and     therefore presumed to be secreted into breast milk. Additionally, the difference between     modes of consumption (ie. smoked vs. edible) has not been well described in regards to THC     concentration in breast milk. The purpose of this small pilot study is to describe the     presence and duration of THC expression in breast milk among women who have evidence of THC     exposure at the time of labor and delivery or within 72 hours of delivery. The researchers     hypothesize that women with positive urine drug screen for THC within 72 hours of delivery     may excrete THC in breast milk for a predicted period of time, and therefore the aim of this     project is to determine timing to safely return to breastfeeding to decrease infant exposure     to THC.      The specific aims are to determine in women who test positive for THC at delivery:        1. Determine length of time THC and metabolites are detected in breast milk of mothers who          have a positive urine drug screen at the time of presentation for labor and delivery or          within 72 hours of delivery.        2. Determine length of time THC and metabolites are detected in breast milk of mothers with          postnatal exposure of either ingested or inhaled marijuana, to inform recommendations on          when to safely return to breastfeeding.        3. Describe modes of marijuana consumption in women presenting for delivery and correlate          with THC concentrations and persistence in breast milk.   "
254668|NCT02639676|"     Pregnant mothers who develop high blood pressure and other vascular problems (preeclampsia)     deliver babies with increased neonatal health problems, which include lung disease and     vascular complications, later in life. Investigators will evaluate whether infants of mothers     with preeclampsia have evidence for impaired development of the lungs and blood vessels.   "
255301|NCT03248765|"     The purpose of this study is to determine if the research results obtained in animal models     of pain - that show that being in pain for some time increases opioid use beyond what is     expected to treat the current pain - also apply to patients with chronic pain.   "
254670|NCT02809482|"     Peripheral tissues (e.g. liver, adipose, muscle) express self-sustained circadian clocks that     coordinate daily metabolic rhythms. The timing of clock rhythms in peripheral tissues is     highly sensitive to feeding-fasting signals across the sleep-wake transition. Nutritional     insults such as high fat overfeeding (HF-OF) have been shown to attenuate clock gene     expression in peripheral tissues resulting in a deleterious re-programming of the circadian     metabolome. Studies in humans have only superficially investigated how the circadian clock     machinery is impacted by nutritional signals. The overall goal of this pilot project is to     take the first steps toward developing translational methods to investigate links between     changes in energy flux and the circadian system in human tissues. Using an innovative ex vivo     cell culture approach the investigators will examine the impact of 3-days of HF-OF compared     to eucaloric (EU) feeding on the expression of core clock genes in human subcutaneous adipose     tissue (SAT). The Investigators hypothesize that compared to EU, the amplitude of clock gene     expression in SAT measured over 24hrs will be attenuated following short-term HF-OF. This     pilot project will serve as a launch point for designing future studies into the effects of     diet and exercise on the circadian control of metabolism in adipose tissue depots as well as     other tissues (e.g. muscle).   "
254671|NCT02626182|"     This study evaluates the ability of the drug sildenafil to improved exercise capacity,     cardiac performance during exercise, and quality of life in patients with moderate to severe     CF lung disease. 3/4 of the subjects will receive sildenafil and 1/4 will receive placebo.   "
254672|NCT02622516|"     Vertigo, dizziness and imbalance are the main symptoms of vestibular dysfunction. They can     lead to physical consequences, such as the reduction of postural control and falls,     psychological and / or psychiatric consequences such as anxiety and depression, panic and     cognitive changes, especially in the elderly. It is known that individuals affected by these     disorders may improve with the completion of vestibular rehabilitation protocol.Treatment     protocols can introduce variability of exercises to control the signs and symptoms related to     vestibular diseases, in order to customize the treatment to affected individuals .   "
254674|NCT02616640|"     This is a multicenter, open-label, Phase 1b study to determine the recommended dose and     regimen of durvalumab either as monotherapy or in combination with POM with or without low     dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a     parallel dose-expansion portion to determine the optimal dose and regimen.   "
254675|NCT02619318|"     This is a RCT study, aiming at evaluating the effectiveness of the Everyday Life in Balance     (BEL) intervention.      The intervention: The BEL was developed on the basis of previous research on lifestyle     interventions made by the current research group and other researchers . It is a group-based     programme (5-8 participants) with 12 sessions, one session a week, and 2 booster sessions     with two-week intervals. The themes for the group sessions are, e.g., activity balance,     healthy living, work-related activities, and social activities. Each session contains a main     group activity and a home assignment to be completed between sessions. The main group     activity starts with analysing the present situation and proceeds with identifying desired     goals and finding strategies for how to reach them. The home assignment is aimed at testing     one of the proposed strategies. Self-analysis, setting goals, finding strategies and     evaluating the outcome of tested strategies form a process for each session, but also for the     BEL intervention as a whole. After completed BEL, the participants will have developed an     ability to reflect on their own situation and have strategies for changing their everyday     life in a desired direction, such that they feel their everyday life has a satisfactory     balance between rest and work, secluded and social activities, etc.      The BEL intervention is led by occupational therapists. They take part in a specifically     developed two-day education and follow the BEL manual [7]. They also participate in a     web-based discussion forum where they can seek support from the researchers and/ or other BEL     occupational therapists.      Selection of units and participants: On the basis of blocks of four units, two are randomized     to the BEL and two to the control condition, which is care as usual (CAU) and generally means     standard occupational therapy. Occupational therapists in the units select participants based     on the patients' needs for a lifestyle intervention and being likely to benefit from a group     intervention. The same criteria are applied in the BEL units and the CAU units.      Power analysis: The investigators desire 120 participants from each group. This will also     allow for analysis of subgroups.      Instruments: A number of self-report instruments tapping satisfaction with daily occupations,     well-being, perceived worker role, social interaction, recovery etc., will be used,     supplemented with qualitative interviews.      Procedure: As the intervention starts, the attendees answer questionnaires about their     personal situation regarding. Subsequently, the BEL is implemented in the units randomised to     that condition. After 16 weeks of intervention (including the booster sessions), the     measurements are repeated. A follow-up is then made after another six months. The same data     collection is made at corresponding time points in the comparison units.      Additional qualitative interviews are made in the intervention units, with strategically     selected participants (attendees and staff) to get a deeper picture of the intervention     process and its implications.      When the research project is finished, the comparison units will be given the opportunity to     go through the intervention.      Analyses: The primary analysis concerns differences in outcomes between the BEL group and the     CAU group. Analyses of the qualitative interviews, by means of grounded theory, will yield a     more detailed description of the BEL and its implications, as perceived by both attendees and     staff.      Current state of the study: The project is in the initial phase and the first units were     recruited in late 2012. At present, 24 units have been randomized to either condition. The     second measurements (after completed BEL) have just been completed and follow-ups will     continue until mid-2016, as will qualitative interviews. Analysing data and reporting results     will continue until late 2018.      By including 60 participants in each group the studies will be able to detect a medium effect     size (ES=0.4), which would be a difference of clinical and practical significance.      Age, gender and being of foreign origin will be considered as covariates, along with other     socioeconomic factors such as family situation, educational level and money at one's     disposal. Other factors that should be considered are the participant's functional status and     diagnoses. Research has not shown that diagnosis per se plays any substantial role in the     outcome of psychiatric rehabilitation, for the course of a psychiatric disability or for how     people perceive their everyday occupations, but this should be investigated further because     the evidence is inconclusive. Level of functioning, level of psychopathology, and negative     symptoms have indeed been shown to be of importance for outcomes of psychiatric     rehabilitation. Therefore, this project will also control for factors related to diagnosis     and functional status.   "
254678|NCT02611921|"     The purpose of the study is to determine if intranasal ketamine shows initial evidence of     safety, tolerability and efficacy for the treatment of social impairment in individuals with     Autism Spectrum Disorder.   "
254679|NCT02623803|"     The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to     pancreatectomy patients in regards to analgesia and return of bowel function.   "
254680|NCT02607033|"     This study is designed to examine the added benefits of weight loss to an exercise program in     older obese Veterans with peripheral arterial disease. The investigators want to determine if     weight loss in addition to exercise will 1) improve walking ability to a greater extent than     exercise alone and 2) determine the underlying reasons why walking ability improves by     measuring blood flow and the amount of muscle in the leg muscles.   "
254681|NCT02608190|"     Purpose: Stroke is a common cause of death and disability in Canada. Injury to the right     hemisphere of the brain and the parietal cortex in particular, is common and results in a     disorder known as 'neglect' in 40% to 95% of patients. These patients fail to attend to or     respond to events occurring in left space; the disorder is devastating for the patient and     their caregivers with the patient becoming dependent on assistance for most activities of     daily life (ADLs).      The project will implement two visual working memory (VWM) training programs to explore the     influence of VWM training on neglect symptoms as well as activities of daily life.      Hypothesis: It is hypothesised that SWM training protocols will lead to improvements of     neglect symptoms as well as improvement in ADLs.      The project will develop a novel rehabilitation strategy for treating the neglect syndrome.      Evidence from research in healthy participants employing video games to improve cognition     along with research using working memory training protocols showing a broad range of benefits     accruing to both trained and untrained tasks, suggests that the investigators approach has     great potential to improve the core deficits of the neglect syndrome. Thus, WM training     represents a promising avenue for rehabilitating neglect patients who demonstrate core     deficits in both spatial attention and VWM to be highly interrelated functions.   "
254683|NCT02598401|"     The aim of this research is to examine the natural history of osteonecrosis in older     children, teenagers and young adults with acute lymphoblastic leukaemia and lymphoblastic     lymphoma within the UK. In addition to using and validating new, internationally agreed,     standard definitions for osteonecrosis, this study will provide the data needed to develop a     radiological classification which correlates with clinical status.   "
254684|NCT02598752|"     The purpose of this study is to see if exercise fitness testing, is feasible and safe in     persons over 50 years of age who have been diagnosed with acute myeloid leukemia (AML) or     myelodysplastic syndrome (MDS) and who are scheduled to undergo a hematopoietic stem cell     transplant (HCT). Assessments in this study include several physical tests to look at the     capacity of your body before and after transplantation to see if these measures can help     predict how patients do after transplant.   "
254689|NCT02596893|"     The purpose of study is to test the effects of an experimental medication GED-0301     (mongersen) in patients who have active Crohn's disease. The study will test GED-0301     compared to placebo for 52 weeks. The study treatment is blinded which means that patients     and the study doctor will not know which treatment has been assigned. Patients in this study     will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids,     immunosupressants and antibiotics for the treatment of Crohn's disease.      After 12 weeks in the study until the end of the study, patients who do not have an     improvement in their Crohns disease symptoms will have the option to enter a long term active     treatment study.   "
255302|NCT03263195|"     The purpose of this study is to compare the incidence of Zika virus (ZIKV) infection among     pregnant women with and without Human Immunodeficiency Virus (HIV) infection and to determine     the risk of adverse maternal and child outcomes associated with ZIKV/HIV co-infection across     clinical sites in the continental United States (U.S.), Puerto Rico (P.R.) and Brazil.   "
254704|NCT02564263|"     In this study, participants with advanced or metastatic adenocarcinoma or squamous cell     carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction     (EGJ) that has progressed after first-line standard therapy will be randomized to receive     either single agent pembrolizumab or the Investigator's choice of standard therapy with     paclitaxel, docetaxel, or irinotecan. The primary study hypothesis is that treatment with     pembrolizumab will prolong overall survival (OS) as compared to treatment with standard     therapy.   "
254692|NCT02592642|"     Arthritis of the spine causes narrowing of the spinal canals and compression of the spinal     nerves traveling into the legs, limiting walking ability. The vast majority of individuals     with arthritis of the spine are not suited for surgery and most receive non-surgical     treatment. However, we do not know what non-surgical treatments are effective in improving     walking in these people. The purpose of our research is to test four new treatments for     arthritis of the spine to see if they can improve walking ability. Each treatment approach     focuses on the changes that occur in the spine and the whole person as a result of the     arthritis that directly or indirectly impacts the ability to walk and perform usual daily     activities. Because arthritis of the spine is a chronic condition usually does not go away,     it is important that people acquire the knowledge, skills, and tools to manage their     condition on their own. The treatments that investigators plan to test as part of this     research proposal are aimed at achieving this goal. However, before the investigators can     promote the use of these treatments they need to formally test them using strict scientific     methods to make sure they do more good than harm. The four treatments include 1) a six week     training program referred to as Boot Camp for Stenosis which provides one-on-one training     on exercise and self-management strategies 2) a patient educational workbook and video on how     to self-manage, 3) an electrical device that is placed on the lower back to reduce nerve pain     when walking and 4) a spinal stenosis belt that people can wear to reduce pressure on the     nerves while walking. The plan is to assess the change in walking distance using the various     treatments and assess what impact the treatments have on peoples' overall function and     quality of life. Innovative treatment approaches with a long term perspective are urgently     needed to deal with the growing number of people with arthritis of the spine who are     disabled. It is likely that there is not one solution to this problem - many people will     require more than one type of treatment, but an important first step is to determine which     treatments are effective, then tailor the treatments to the needs of each person.   "
254693|NCT02588326|"     Currently FDA does not accept pharmacokinetic studies to show bioequivalence of     locally-acting nasal suspension formulations.      However, bioequivalence is defined as the absence of significant differences in     pharmacokinetics of therapeutically equivalent drug products compared to the matching     originally invented drug formulation. These there-called generic drugs are then     interchangeable. Drug companies have to show that their generic version has the same active     ingredient, the same label, is intended to be used for the same conditions or diseases and     works at the same rate in the body.      The aim of the study is to determine if pharmacokinetics is sensitive to differences in the     particle size distribution of three different nasal suspension formulations of mometasone     furoate during charcoal block. The result from this study will aid the FDA in finding methods     to ensure that generic products are the same as the trade name drugs.   "
254694|NCT02610374|"     The primary objective is to assess the effect of short-term diet modification on the     microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy     (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative     controls in the United States.   "
254695|NCT02587962|"     An ascending dose study in patients with solid tumors to evaluate the safety, tolerability,     pharmacodynamics and efficacy of birinapant when given in combination with pembrolizumab.   "
254696|NCT02580604|"     Declines in serum calcium during exercise may cause increases in markers of bone resorption.     This study will determine if preventing the decline serum ionized calcium experienced at the     onset of exercise through the use of a calcium clamp also prevents increases in blood     biomarkers associated with bone resorption.   "
254698|NCT02578836|"     This study assesses weight loss from the Endoscopic Vertical Gastroplasty or Fogel     Gastroplasty (FG). The purpose of the study is to:        -  Document that weight loss occurs (12 months)        -  Determine if it alters general wellbeing (emotionally and physically)   "
254699|NCT02584309|"     The purpose of this research study is to look at whether giving a drug called dexrazoxane     plus olaratumab with standard of care doxorubicin affects the progression of the disease.     Dexrazoxane is often given at the same time as doxorubicin to help reduce the incidence and     severity of disease of the heart muscle (which can be caused by doxorubicin).   "
254701|NCT02579395|"     In a 6-week experimental design, up to 90 adult couples in which one partner has Type 2     Diabetes (T2D) will be randomly assigned to either the collaborative implementation     intentions (Collaborative IIs), the Individual Implementation Intentions (Individual IIs)     condition, or the control condition. As this is a pilot study, randomization for the     experimental groups vs the control groups will occur at a 2:1 ratio. Thus, the experimental     conditions will contain up to 36 participants and the control condition will contain up to 18     participants. Adults with T2D who are living with a romantic partner, not meeting current     physical activity guidelines but able and willing to begin a new physical activity (PA)     routine and their partners will be assessed at baseline, 3 weeks and 6 weeks after the     experimental manipulation. Partners will report on their own investment in the patient's goal     and patients will report on their own PA self-efficacy. Patient's PA will be measured through     self-report, partner report and accelerometers for a week prior to each survey assessment.     These specific aims are planned:      AIM 1: Determine whether collaborative IIs for patient's PA lead to a greater increase in     partner investment in partners of adults with T2D than do individual IIs or control.      AIM 2: Determine whether collaborative IIs for patient's PA lead to a greater increase in     patient PA self-efficacy in adults with T2D than do individual IIs or control.      AIM 3: Determine whether collaborative IIs for patient's PA lead to a greater increase in     patient PA in adults with T2D than do individual IIs or control.   "
254705|NCT02562443|"     The study's primary objective [in a population of patients with MDS after failure of     treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival     (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and     in a subgroup of patients with IPSS-R very high risk.   "
254706|NCT02609451|"     The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in     patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12     weeks.   "
254707|NCT02553655|"     The investigators would like to determine if remote ischemic leg preconditioning in healthy     volunteers improves cerebral vasomotor reactivity as measured by breath holding and     transcranial doppler vasomotor reactivity.   "
255817|NCT02568267|"     This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for     the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene     fusion. Patients will be assigned to different baskets according to tumor type and gene     fusion.   "
254708|NCT03247933|"     Respiratory rehabilitation (RR) has been shown to provide benefits in patients with Chronic     Obstructive Pulmonary Disease (COPD) with a degree of evidence A.      These benefits are primarily focused on an increase in the capacity of effort for activities     of daily living and in an improvement in the quality of life related to health (HRQOL) a     constant to the RR critique is the fact that the benefits achieved with programmes are lost     in a progressive and constant way once the patient completes the treatment and lost contact     with the team.      The introduction of new technologies in different fields of medicine has been a new approach     when it comes to the management of various diseases and treatments in chronic patients. In     the case of the RR telemedicine provides a new tool.      COPD disease very prevalent and chronic it is generator of a high economic cost. The     possibility of universalizing the rehabilitation treatment would involve a potential savings     in this population group ,another potential benefit is as translational trial as part of the     development of a new technology and its possible application to clinical practice.      General objective: to determine whether a program of TeleRehabilitation (TeleRR)- Respiratory     Rehabilitation Maintenance (RRm) after an intensive initial program of RR, is a useful     intervention against the current usual strategy (intensive program of RR and a recommendation     of not protected maintenance program).      Method: clinical trial , open, randomized, multicenter, parallel group, and focus of     superiority with a strategy of Telerehabilitation program respiratory of maintenance after an     intensive RR for 8 weeks in patients diagnosed with grade moderately - severe stable COPD     (Bode 3-7).   "
254710|NCT02550691|"     Spinal Muscular Atrophy (SMA) is a neuromuscular disorder characterized by loss of motor     neurons in the anterior horn of the spinal cord and leading to muscle atrophy. SMA has an     autosomal recessive inheritance and affects 1 in 6000 infants with a carrier frequency of 1     in 40. In most cases, it is caused by homozygous gene deletion or gene conversion of the SMN1     gene (0+0 genotype) on 5q11-q13. This genomic region has been duplicated and inverted during     evolution. Thus the SMN1 gene has a very homologous copy, called SMN2. Genetic counseling aim     at detecting carriers with only one copy of the SMN1 gene (0+1 genotype). SMA carrier testing     relies on total copy number quantification of the SMN1 copies by quantitative PCR methods.     Nevertheless, cis-duplication of the SMN1 gene on one allele and deletion on the second     allele (2+0 genotype) can lead to a misinterpretation as molecular methods show 2 copies of     the SMN1 gene and cannot detect the carrier status.      The aim of the study is the characterization of a biomarker specific of the cis-duplication     of the SMN1 gene in order to allow the detection of this 2+0 genotype which constitutes a     trap for genetic counseling. We will use molecular combing to identify a genomic morse code     (GMC) composed of a combination of probes specific of a structural motif on the     cis-duplication chromosome. The characterization of this GMC is based on the comparison of     two sample groups:        -  The test group, with a maximum of 137 individuals carrying 3 copies of the SMN1 gene          (suggesting a cis-duplication on one allele)        -  The control-1 group, with a maximum of 137 individuals carrying 2 copies of the SMN1          gene      A pilot study performed on 24 samples in the two groups is needed to define the exact sample     number necessary for statistical analysis of the study. When the GMC will be characterized,     its specificity will be evaluated by testing two sample groups:        -  The test group, with 37 individuals carrying 3 copies of the SMN1 gene        -  The control-2 group, with 37 individuals carrying 3 copies of the SMN2 gene Molecular          combing needs long DNA fibers and usual methods for DNA extraction are not appropriate.          This project requires new blood samples for specific DNA extraction.      If this project is successful, during a second project, this GMC will be converted into a     simple and cheap PCR-based method. We will then evaluate the sensitivity of this method on     our sample collection, notably on individuals with the 2+0 genotype defined by familial     genotyping.   "
254711|NCT02546999|"     In Norway, about 60% of all children with cerebral palsy (CP) are being treated with     botulinum toxin A (BoNT-A) at 6 years of age, mainly in the legs. Despite this widespread use     of the drug, the evidence for a positive effect on walking is insufficient. Moreover, large     variation in effect is seen by clinicians. The main objective of the present study is to     investigate whether injections with BoNT-A in the calf muscles make walking easier in     children with spastic CP within 6 months, reflected by reduced energy cost during walking.   "
254713|NCT02535689|"     Background:      Systemic lupus erythematosus (lupus) is an autoimmune disease that often involves many     systems and organs of the body. Symptoms can include fever, joint pains, and rashes. Serious     lupus can also damage organs like the kidneys, lungs, or brain. Drugs used for lupus can have     serious side effects. Also, the drugs don t help some people. Researchers want to find new,     more effective and safe treatments.      Objective:      To evaluate the safety and tolerability of the drug tofacitinib (study drug) in people with     lupus.      Eligibility:      People ages 18 and older who have mild to moderate lupus and are not currently or haven t     recently had certain lupus treatments.      Design:      Participants will be screened in another protocol.      Participants will have 7 five-hour visits over about 3 months. They will fill out multiple     questionnaires. They will have tests, including:        -  Physical exam        -  Blood and urine tests        -  ECG/EKG: Soft electrodes are stuck to the skin to monitor the heart.        -  Optional SphygmoCor: Cuffs are attached to the arm and thigh to measure blood pressure          and flow speed.        -  Optional Endopat: A thimble-shaped cup is placed on the finger to measure blood flow. A          cuff is put on the arm to measure blood pressure and flow.        -  Optional CAVI: ECG electrodes are placed on both wrists, a microphone placed on the          chest, and a blood pressure cuff placed on each arm and leg to measure blood pressure          and velocity.      Participants will receive either the study drug or a placebo. They will take this twice a day     by mouth for 56 days.      Participants will be contacted by phone 4 times.   "
254836|NCT02267603|"     This phase II trial studies how well pembrolizumab works in treating patients with Merkel     cell cancer that cannot be removed by surgery or controlled with treatment, or has spread to     other parts of the body. Pembrolizumab may stimulate the immune system to identify and     destroy cancer cells.   "
254714|NCT02544321|"     Type 1 diabetes (T1D) continues to be a disease plagued by hyperglycemia, insulin resistance     (IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and     glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA)     agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its     recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an     exciting development, representing a novel mechanism for improving IR. BCQR has not been     studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data     support the proposed study of possible benefits of BCQR on insulin action, glycemic control,     and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR     in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This     is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes     will include fasting and postprandial glucose, glycemic variability, insulin dosing,     hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.   "
254717|NCT02530398|"     To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on     digestive system cancer patients with malignant ascites, and propose dosage regimens for     future clinical trials. The clinical trial is divided into two parts, including single and     successive administration.   "
254721|NCT02577601|"     The purpose of this research study is to determine if taking a birth control pill effects how     well an emergency contraceptive pill called Ulipristal acetate (UPA) works. This type of     emergency contraceptive is the most effective oral method available. However, this medication     is an anti-progestin and most regular forms of birth control contain progestin (a female     hormone). It is unknown if taking the two close together may make the emergency contraceptive     not work well. The overall goal of this research is to improve the effectiveness of     contraception for women and to better counsel women.   "
254722|NCT02553096|"     Aim is to test the effect of ACCESS (Adaptive Computerized COPD Exacerbation Self-management     Support), a software application designed to support patients with COPD in self-management     of exacerbations.   "
254723|NCT02519101|"     Continuous noninvasive blood pressure monitoring may help to avoid intraoperative Hypotension     or Hypertension   "
254724|NCT02519348|"     This is a multicenter, open-label, stratified, randomized study to evaluate the safety,     tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736     (Durvalumab) in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab     monotherapy in subjects with unresectable hepatocellular carcinoma   "
254751|NCT02463123|"     Estimation of energy requirements is essential for adequate nutritional support in ICU.     Indirect calorimetry being the golden standard of resting energy expenditure estimation is     not available in most intensive care units. Different predictive equations have been     developed, but not evaluated in cardiac population and have low accuracy in compare to the     indirect calorimetry. The aim of present study is to develop cardio-specific equation for     resting energy expenditure estimation.   "
254725|NCT02511015|"     Background:      - Parkinson s disease is a disease of the nervous system that affects movement. People     usually get it in their 70s or 80s. Early onset Parkinson s disease (EOPD) begins before the     age of 50. Researchers think EOPD may be caused by a mutation in a gene. They want to study     the genetic causes so they can find therapies for this disease.      Objective:      - To better understand the genetic causes of EOPD.      Eligibility:        -  Adults ages 18 80 with a history of EOPD. Their family members, who do not have          Parkinson s disease, can join as controls.        -  Healthy volunteers ages 18 80.      Design:        -  Participants with EOPD and their relatives will be screened with a review of medical          records. Healthy volunteers will have medical history, physical exam, and blood drawn.        -  Relatives may send blood samples to NIH to test for mutations in genes that are linked          to Parkinson s disease. They may have a physical exam.        -  Participants may be asked to return to clinic for another visit that can last up to 2          hours.        -  During this visit, participants will have blood taken from a vein in the arm via a          needle stick.        -  Participants may give a sample of their skin. The skin on the arm or leg will be numbed          and a small skin punch biopsy will be taken with a special needle.        -  Some cells from the blood or skin sample may be grown in a lab to establish cell lines.          The cells may also potentially be genetically modified to make stem cells.        -  Researchers may perform genetic analysis on the samples to compare them to EOPD patient          samples.   "
254728|NCT02508649|"     This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. The     trial is designed to investigate the efficacy and safety of multiple dosing regimens of     selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of     adult patients with septic shock requiring vasopressor.   "
254729|NCT02515578|"     Heart disease and strokes cause one in three deaths reported each year in the United States.     Primary care practices need to implement new research findings that help decrease patients'     risk for heart disease and stroke. This project will help to build primary care practice     capacity for quality improvement and change management in small and medium size primary care     practices in Colorado and New Mexico. This project will also help practices implement     patient-centered outcomes research findings.   "
254732|NCT02512913|"     The purpose of this research is to adapt and implement a pregnancy and postnatal smoking     cessation intervention for couple that will begin early in pregnancy and have an additional     postnatal component.   "
254735|NCT02493764|"     This study aims to compare treatment with imipenem/relebactam/cilastatin (IMI/REL) as a     fixed-dose combination (FDC) with piperacillin/tazobactam (PIP/TAZ) FDC in participants with     hospital-acquired and ventilator-associated bacterial pneumonia. The primary hypothesis is     that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.   "
254737|NCT02499900|"     The primary objective of this study is to compare patient medication satisfaction as measured     by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three     time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of     treatment.   "
254752|NCT02464670|"     This study evaluates whether INO-4212 and its components INO-4201 and INO-4202 administered     intramuscularly (IM) or intradermally (ID) followed by electroporation (EP) will be well     tolerated and immunogenic.   "
254837|NCT02266147|"     To assess the safety and tolerability of escalating doses of SD-101 in combination with     localized low-dose radiation therapy in adult subjects with untreated low-grade B-cell     lymphoma.   "
254739|NCT02488616|"     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required     insulin dosages based on the sensor's readings.      The main objective of this project is to compare the efficacy of single-hormone closed-loop     strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings     for 5 consecutive days in adults with type 1 diabetes.      The investigators hypothesized that single-hormone closed-loop strategy will increase the     time spent in the target range compared to sensor-augmented pump therapy.   "
254740|NCT02486016|"     This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare     fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan)     fentanyl skin patches in healthy adults.   "
254741|NCT02487160|"     The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular     lens.   "
254748|NCT02472860|"     The investigators will conduct a randomized placebo-controlled trial of a computerized     intervention targeting cognition in 30 teens with autism spectrum disorder.   "
254753|NCT02463305|"     This study plans to learn more about the effects that creatine monohydrate has on disease     activity in ulcerative colitis. Creatine is a substance that is naturally produced by the     body and is found in foods, such as meat and fish. Creatine helps to provide energy to some     body tissues, such as the colon. In the colon, this energy allows cells to form a tight     barrier between molecules in digested food and bacteria and the body's infection-fighting     cells within the colon underneath this barrier. If the barrier becomes leaky molecules may     pass through and lead to inflammation. This leakiness may contribute to the colon     inflammation seen in ulcerative colitis.   "
254754|NCT02474355|"     The aim of this study is to assess the efficacy and safety of single agent AZD9291 in a real     world setting in adult patients with advanced or metastatic, epidermal growth factor receptor     (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), who have received prior     EGFR-tyrosine kinase inhibitor (TKI) therapy.   "
254755|NCT02456077|"     The purpose of this study is to determine if a multimodal Human Papillomavirus (HPV)     immunization program carried out in pediatric and family medicine practices would be more     effective in improving adolescent patients' HPV immunization rates than the usual care     provided to adolescents in pediatric and family medicine practices.   "
254756|NCT02458313|"     Obesity is a serious and growing health problem in the United States. Obesity is associated     with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased     quality of life and increased mortality. Given the health and quality-of-life effects of     obesity, developing effective treatments clearly is an important goal.      This study plans to learn more about the effects of an investigational new drug (DMXB-A     (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has     similar effects to nicotine. Since nicotine has been found to affect appetite, the     investigators are interested in studying effects of the study drug, which has some     similarities to nicotine, on how your brain responds to such things as pictures of food. The     study drug has not been approved by the Food and Drug Administration (FDA), and is considered     experimental.   "
254757|NCT02453737|"     This is an open label phase II study to determine the safety and efficacy of a novel 3     fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early     invasive and noninvasive breast cancer. The three techniques utilized are recognized as     standard options for the delivery of APBI, and there is no evidence that either technique is     superior or inferior to any other. The APBI technique utilized will be at the physician's     discretion and will be based on technical considerations, availability at the treating     radiation facility, insurance coverage, as well as patient preference.   "
254758|NCT02464410|"     The high rate of adverse events, including overdose, resulting from opioid pain medication     use threatens the quality and safety of pain care in the Veterans Health Administration (VHA)     and elsewhere and is a critical public health problem in the United States. Pain is a highly     common condition among VHA patients, and opioid therapy constitutes a primary mode of pain     treatment.      This study seeks to address this issue by conducting a randomized controlled trial of a brief     conversation to improve opioid safety among Veteran patients receiving long-term opioid     therapy. Veterans receiving opioid therapy for pain in primary care will be recruited and     randomized to receive either a single session motivational intervention focused on safe     opioid use or an equal attention control condition. The primary hypothesis is that the     motivational intervention will improve opioid safety, decrease risk behaviors, aberrant     opioid use, and total quantities of opioids prescribed relative to the control condition.     Study findings will inform efforts to ensure the safety and well-being of Veteran patients     with pain.   "
254759|NCT02455193|"     This study plans to learn more about how common drugs prescribed to individuals with     schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite and     the brain's response to food. In this study, the investigators will be evaluating how     patients' brains respond to food images as well as asking questions about their food     preferences and intake and clinical symptoms. The investigators may also ask patients to     complete an exercise or diet intervention to see how this changes brain responses or food     preferences.   "
254761|NCT02457520|"     This is an uncontrolled, open-label study being conducted in approximately 200 healthy males,     non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.      ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by     1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or     abstinence are included.   "
254762|NCT02449369|"     This is a prospective, three-arm, randomized, open-label trial to determine if a new pain     control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine     for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces     average pain scores.   "
254763|NCT02492360|"     This study targets patients with cisplatin-induced peripheral neuropathy and will allow us     to: a) study peripheral neuropathy in diverse human sensory neurons in ways that were not     possible previously; b) gain insight on druggable targets to treat or prevent this     devastating side effect of chemotherapy; c) provide a human cellular model that can be used     for screening of drugs to determine if they are neurotoxic. The combination of patient     information and in vitro measurements provides a highly relevant and clinically useful model     for studies aimed to impact treatment selection for the individual cancer patient.   "
254768|NCT02478775|"     Excess maternal weight, especially obesity, influences almost every aspect of fertility, from     conception to problems during pregnancy. The investigators will use novel statistical methods     to clarify the hormonal changes behind reproductive health conditions. A better understanding     of reproductive hormonal changes in obese women may offer a way to identify new treatments.   "
254771|NCT02473926|"     This study plans to learn more about physical activity and physical function in sedentary     older adults with type 2 diabetes.   "
254810|NCT02332369|"     This study evaluates the safety and effectiveness of a capsular tension ring (CTR) when used     during cataract surgery. Capsular Tension Rings are used during intraocular lens implantation     to give added support in order to keep the intraocular lens well centered, especially in eyes     with weak or partially absent zonules. In many cases, capsular tension rings allow a lens to     be successfully implanted into an eye which otherwise could not have supported an intraocular     lens, and have enabled patients to regain normal activities again after cataract surgery.   "
254772|NCT02427594|"     The purpose of this study is to evaluate changes in urine net acid excretion, blood pressure     and body chemistry that occur when the dietary acid load is lowered by using a drug/dietary     supplement similar to baking soda. This may be important for patients with kidney disease     because they may have difficulty removing all of the dietary acid load from the body in the     urine. Participants with and without kidney disease will be recruited. Each participant will     be fed a controlled diet for one week with sodium bicarbonate and for one week without sodium     bicarbonate to evaluate these changes. The investigators will also determine if the effect of     dietary acid load reduction is different in patients with kidney disease compared to those     without kidney disease.   "
254774|NCT02429466|"     This is an open-label, single arm, Phase I dose escalation study in subjects with refractory     germ cell tumor (rGCT). This phase I will evaluate the safety and efficacy of SGI-110 in     combination with cisplatin in subjects with rGCT. The primary objective is to determine the     maximum tolerated dose (MTD) of SGI-110 to be used prior to cisplatin. A total of 15 subjects     will be enrolled in this study at the Indiana University Simon Cancer Center.   "
254775|NCT02434588|"     During cataract surgery, it is necessary to dilate the iris in order to remove the     crystalline lens and position the implant. The diameter of the optical implant being 6 mm, in     case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm.      At pre-operative consultation, the iris is always dilated by instillation of eye drops and     measured at the slitlamp. For patients with an inadequate dilation, the intervention requires     the use of a mechanical dilatation device.      This study aims to assess the value of an alternative dilatation ring to Malyugin ring, which     can be inserted and removed through an incision of less than 2 mm in diameter, due to its     size smaller than that of the Malyugin ring.      Our hypothesis is that this Bhattacharjee ring ensures sufficient and stable iris dilation     during surgery, enabling implant placement in good conditions.   "
254776|NCT02444611|"     Neonatal morbidity and mortality from infectious diseases is of global concern. Childhood     disease-specific immunisation is irrefutably linked to the decline in deaths from these     targeted infections over the last century. However, neonatal immunisation is limited, in     part, by the impaired adaptive immune function in this age group.      There is now an expanding body of evidence for heterologous ('non-specific') effects of     various vaccines used in childhood. This refers to the immunomodulatory capabilities of     vaccines to influence immune outcomes beyond the vaccine's specific targeted disease. The     underlying immunological mechanisms responsible for these effects are incompletely     understood, but evidence is mounting that the innate immune system is central to these     observed effects.      This study is a randomised controlled trial designed to determine the influence of two     commonly administered neonatal immunisations, BCG and Hepatitis B vaccine, given at birth, on     the neonatal immune responses to non-specific antigens.      The investigators will recruit 200 newborns at the Mercy Hospital for Women in Melbourne,     Australia over a 1-year period. These babies will be allocated randomly to one of 4 groups,     receiving these 2 vaccines in different combinations, at 2 set time points. (at birth and 1     week post randomisation) A blood sample will be taken at 1-week post randomisation for in     vitro immunological analyses.      This study will improve current understanding of the influence of vaccines on neonatal     immunity and will help develop strategies exploiting beneficial heterologous ('non-specific')     effects to improve protection against infection in the very young.   "
254778|NCT02408510|"     The goal of this proof of concept/feasibility study is to use rigorous methodology to explore     links between daytime energy status and nocturnal fat metabolism in healthy adults.   "
254780|NCT02412735|"     This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3     study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or     combined with hyaluronic acid (HA) in subjects with chronic low back pain (> 6 months)     associated with moderate radiographic degenerative changes of a disc   "
254781|NCT02402153|"     To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm     device   "
254782|NCT02425579|"     The purpose of this study is to assess the safety of inhaled carbon monoxide (iCO) in     intubated patients with sepsis-induced ARDS.   "
254783|NCT02401542|"     This is a Phase 1b/2, randomized, double-blind, placebo-controlled, multicenter,     parallel-group study of B-701 plus docetaxel versus placebo plus docetaxel in the treatment     of locally advanced or metastatic urothelial cell carcinoma in subjects who have relapsed     after, or are refractory to standard therapy.   "
254784|NCT02400762|"     The purpose of this study is to collect on-label safety and efficacy data where InQu Bone     Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior     lumbar interbody fusion (PLIF).      It is expected that this study will contribute to the compilation of clinical data required     to demonstrate the ability of InQu to promote safe, effective and timely spine fusion in     patients who undergo PLIF or TLIF surgery. The results of this study will lead to further     analysis (i.e. comparison to historical data of other marketed bone graft products, as well     as, to local bone alone).   "
254811|NCT02346409|"     Essential tremor (ET) is a frequent and disabling disorder with progressive worsening of     postural tremor of the upper limbs that impairs most of the manual activities of every day     life (feeding, drinking, etc.). Although the pathophysiology of essential tremor (ET) is not     fully elucidated, tremor is associated with abnormal activity within different brain regions,     in particular the thalamus and the cerebellum. Deep brain stimulation (DBS) of the ventral     intermediate nucleus of the thalamus (VIM-Thal) reverses the symptoms of tremor but is an     invasive procedure. Transcranial stimulation of the cerebellum may represent a non-invasive     therapeutic option for ET patients. Here, the investigators propose to test the efficacy of     cerebellar stimulation in 15 ET patients previously operated for DBS of the thalamus. To     further understand how this treatment provokes tremor reduction, the investigators will     analyse the brain neuronal activity in 13 others ET patients candidate to thalamic DBS by     using combined electrophysiological recordings of the thalamus (with the electrodes     implanted), the cerebellum and the cortex with magnetoencephalography.   "
255525|NCT03032380|"     To compare all-cause mortality at Day 14 in participants receiving S-649266 with participants     receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia     (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial     pneumonia (HCABP) caused by Gram-negative pathogens.   "
254785|NCT02379442|"     Background:      - Sometimes after stem cells are transplanted, donor cells attack the recipient s cells and     cause tissue damage. This is called acute graft-versus-host-disease (GVHD). Researchers want     to see if bone marrow-derived mesenchymal stem cells (BMSC) can help treat GVHD. BMSC can     travel in the body and help repair tissue. The BMSC in this study were grown from bone marrow     from healthy volunteers.      Objectives:      - To test whether BMSC are safe to use soon after GVHD is diagnosed and to see how the body s     immune system responds to BMSC.      Eligibility:      - People over 4 years old who had a stem cell transplant at NIH and now have acute GVHD.     People who have had certain previous immunosuppressive therapy may be ineligible.      Design:        -  Participants will be screened with medical history, physical exam, and blood tests. They          will have a GVHD exam, including skin and stool tests. They must have a functioning          central line.        -  Participation will last 11 weeks: 4 8 weeks of cell infusions, then follow-up for the          rest of the weeks.        -  Up to 12 cell infusions:        -  Participants will come to the clinic twice weekly.        -  They will get medicine to prevent side effects (like Tylenol and Benadryl).        -  BMSC will be given through a small plastic tube in an arm vein or through an IV          catheter. It will last 20 60 minutes.        -  Participants will be monitored for 1 hour.        -  Follow-up visits: Up to twice a week, participants will have physical exam and blood          tests. They may have a GVHD exam.        -  Participants who have a tissue biopsy outside the study will be asked to send a sample          to the study.   "
254787|NCT02391519|"     Pregnancy elicits adaptive changes in uteroplacental blood flow, which are altered at high     altitude and may contribute to the observed 3-fold increase in intrauterine growth     restriction (IUGR) and preeclampsia (PreE). The investigators propose to collect myometrial,     cord blood, and placental tissue samples from women at high altitude (Summit County) and low     altitude (Denver) in Colorado in order to determine if residence at altitude during pregnancy     changes the vasoreactivity of myometrial arteries (MA). If altered MA vasoreactivity is     found, further studies may be able to link these changes to the increased rates of PreE and     IUGR at altitude and contribute to the understanding of these two disorders.   "
254788|NCT02382601|"     The investigation will employ a longitudinal approach in which every fetus diagnosed to be     SGA (Small for Gestational Age ) will be studied at frequent intervals with sophisticated     imaging techniques to assess subtle physiologic changes in the brain, heart, and placenta     over time. These findings will be correlated with neurological and cardiovascular function in     the newborn and early childhood. This research initiative should yield diagnostic and     therapeutic templates that will improve the quality of life of IUGR babies in addition to     providing important information that will better inform current diagnostic practices.   "
254789|NCT02399449|"     An approved treatment for anemia or low blood count due to chronic kidney disease is IV     (intravenous, given into the vein) injection of an iron treatment. IV iron increases iron in     the blood. Many IV iron therapies are now available in both brand name and generic forms. One     common IV iron product is sodium ferric gluconate (SFG) sold as brand name Ferrlecit.     Recently, a generic version of Ferrlecit was approved but was felt to be possibly more toxic     than the brand product. The purpose of this research project is to see if the brand and     generic IV iron products produce the same amount of iron in the blood in healthy volunteers,     including an iron form that more toxic than other iron forms.   "
254791|NCT02374541|"     The SaLSA (Screening and Linkage to Services for Autism) study will test whether patient     navigation can help disadvantaged families obtain earlier diagnosis and treatment for their     children who have had a positive screening test for autism spectrum disorder. Half of the     families will be offered help from an autism patient navigator. The other half will receive     standard care.   "
254794|NCT02365636|"     This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment     compared with placebo ointment applied topically and twice daily to the area of PHN pain for     4 weeks in patients with PHN   "
254796|NCT02362594|"     This study will assess whether post-resection adjuvant therapy with pembrolizumab improves     recurrence-free survival (RFS) as compared to placebo for high-risk participants with     melanoma (Stage IIIA [> 1 mm metastasis], IIIB and IIIC). The study will also assess whether     pembrolizumab improves RFS versus placebo in the subgroup of participants with programmed     cell death ligand 1 (PD-L1)-positive tumor expression. Participants will be stratified for     stage of disease and region and then will be randomly assigned to receive either     pembrolizumab or placebo.   "
254800|NCT02359890|"     This is a prospective safety assessment of the study device during radiofrequency (RF)     ablation treatment of patients with drug refractory symptomatic atrial fibrillation     (SMART-SF).   "
254803|NCT02363543|"     The purpose of this randomized, comparative study is to determine whether Hyalomatrix is as     effective as IntegraTM Meshed Bilayer Wound Matrix when used in subjects who receive     concurrent treatments with both products on their first and/or second degree burns located on     both hands.   "
254806|NCT02347527|"     The overall goals of this project are to determine the impact of an implicit priming     intervention, designed to alter food perceptions, on both brain responses to food and on food     intake behaviors in overweight/obese individuals. The investigators hypothesized that this     bottom-up sensory-level conditioning approach would effectively result in reduced preference     for high-calorie foods.   "
254807|NCT02344251|"     In pharmacotherapy trials involving drug-dependent individuals, medication compliance is a     significant issue, as rates tend to be low and adherence to medication may predict improved     outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010).     However, methods commonly used to determine compliance may result in inaccurate measurement     of adherence. In this study, we propose to assess the effectiveness and safety of the     ID-Cap-M, a novel compliance measurement device, in a healthy population.   "
254809|NCT02360202|"     Clinical observation frequently shows a paradoxical effect of topical corticosteroids in     charge of a sudden melting of edema in the first days of treatment, which could be due to     mobilization of extracellular. No study has shown the value of this measure in patients     treated with topical steroids. This uncertainty, coupled with the observation of the     paradoxical effects of topical steroids on edema are some patients that despite the systemic     absorption of clobetasol propionate, a salt-free diet is not currently recommended practice.   "
254812|NCT02334124|"     Many children every year present to the Emergency Department (ED) at The Royal Children's     Hospital (RCH) with cellulitis (skin infection). If it is mild, the children can go home with     oral antibiotic treatment. If it is complicated and severe, these children are admitted to     hospital for intravenous (IV, through a drip) antibiotic treatment. There is a middle group     with uncomplicated moderate/severe cellulitis who require IV antibiotics but who are not     acutely unwell. In order to determine whether it is just as effective for children with     uncomplicated moderate to severe cellulitis to receive antibiotic treatment at home (via     Hospital-In-The-Home) as it is to receive antibiotic treatment in hospital, there is a need     to conduct a larger study and randomly assign children to receive either HITH or hospital     ward care.      The primary research question to be addressed is:      In children with moderate/severe uncomplicated cellulitis, is the failure rate at 2 days     following the first dose of antibiotic non-inferior for children treated with IV antibiotics     at home compared to the failure rate at 2 days following the first dose for children treated     with IV antibiotics in hospital?   "
254813|NCT02347852|"     The purpose of this trial is to quantitatively assess the average amount of physical activity     that patients are capable to perform while receiving regorafenib for the treatment of     metastatic colorectal cancer. The assessment of this reference value, measured by CE     (Conformité Européene)-certified pedometer and international physical activity questionnaire,     will allow an estimation on the feasible amount of physical activity for patients in this     therapeutic setting.      This study is available for patients who are included in the global non-interventional study     CORRELATE (Safety and efficacy of regorafenib in metastatic colorectal cancer patients;     NCT01843400) in Austria.   "
254814|NCT02319434|"     The purpose of this study is to determine the usability and acceptance of the Ostom-i Alert     Sensor. The investigators would like to see if is generally helpful to ostomy patients and     whether it has a beneficial impact on living with an ostomy bag. Results from this study will     be used to determine if a larger clinical study is feasible.   "
254818|NCT02319317|"     The specific aim of this study is to assess the feasibility of a web-based intervention to     prevent risky driving with teen drivers licensed in the previous 90 days.   "
254819|NCT02315729|"     The purpose of this study is to identify potential markers for curve progression in     adolescent idiopathic scoliosis (AIS). Despite its prevalence and impact on child health, the     etiology of AIS and molecular mechanisms underlying its development and progression remain     poorly understood. Clinical criteria and features cannot adequately predict which children,     diagnosed with mild disease, will undergo subsequent curve progression requiring     intervention.      The investigators hypothesize that alterations in specific genetic markers will be correlated     with the progression of AIS curves over time. Thus, these markers could be used in the future     to develop a reliable, inexpensive and relatively non-invasive cell based diagnostic test to     (1) predict spinal curve progression in AIS, (2) select patients likely to benefit from early     surgical intervention, and (3) potentially screen for asymptomatic children at risk of     developing idiopathic scoliosis.   "
254820|NCT02321007|"     The purpose of this study is to establish a tissue and data repository consisting of samples     of human placentas, umbilical cord blood, and maternal blood, collected at the time of     delivery. Specimens will be used in cellular, molecular, and functional studies to learn more     about changes in placental structure and function, which can result in serious pregnancy     complications and determine life-long health by programming the fetus for future metabolic     and cardiovascular disease.   "
254823|NCT02300610|"     The main purpose of this study is to find out the dose of enzalutamide that can be safely     given with gemcitabine and cisplatin in patients with advanced bladder cancer. Researchers     also want to find out the side effects of these drugs when given together. This study will     also help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine     and cisplatin.   "
254824|NCT02299921|"     This study plans to learn more about people who are sick in the hospital with a lung     infection, or respiratory failure. Respiratory failure, or severe lung failure, is a     life-threatening disease. When it happens, the lungs have trouble carrying out their normal     function of getting oxygen into the blood, and removing carbon dioxide from the body.     Investigators are conducting this study to see what drinking too much alcohol, using tobacco     products, or using drugs (both legal and illegal) may do to lung infections and respiratory     failure.      Subjects are asked to be in this research study because they are thought to have a lung     infection and may also have respiratory failure. Alcohol, tobacco, and drug use have been     linked to lung infections, respiratory failure, and even death, but the reasons for this     aren't known. People who use unhealthy amounts of alcohol, tobacco, and or drugs may be more     at risk for lung infections, and for severe complications due to lung infection. Subject     participation is important whether or not you use alcohol and or drugs.   "
254826|NCT02294825|"     All women managed for endometriosis are included and followed up through the CIRENDO     database.      Information is obtained from surgical and histological records and from self-questionnaires     completed before surgery. Standardized gastrointestinal questionnaires (KESS, GIQLI, WEXNER,     FIQL and Bristol) are routinely used to assess bowel function. Data recording, patient     contact and follow-up are carried out by a clinical research technician. Postoperative     follow-up is based on data from the afore-mentioned questionnaires completed at 1, 3, 5 and 7     years.   "
254827|NCT02292017|"     This is a prospective single center trial investigating the effects of prospectively     measuring packing density prior to choosing Target Coils for the treatment of intracranial     saccular aneurysms. Up to 25 eligible subjects with ruptured or unruptured intracranial     saccular aneurysms between 4-20mm (maximum dimension), who consent to study participation,     will be treated with Stryker Target Detachable Coils.      Historical data from patients enrolled in the MAPS trial at the single center will be the     control arm of the trial and reviewed for comparison to the prospective arm. In the control     arm, the subjects received Stryker Matrix2 Detachable Coils and Guglielmi Detachable Coils     and packing density was not measured prior to these procedures. The Pro-Pack Trial will     evaluate the outcomes of the subjects treated with Target Coils, in whom the packing density     will be actively calculated prior to coil selection. This will serve to establish that a     higher packing density can be obtained by the change in methodology of coil selection and a     higher packing density with lower recurrence rates.   "
254833|NCT02284087|"     Introduction The motor impairment of the upper extremity is the most common sequelae after     ischemic stroke. Transcranial magnetic stimulation (TMS) is a promising non- invasive     technique in the rehabilitation of motor deficits. However, its effect in post-stroke motor     deficits remains moderate our days. To potentiate the effect of TMS, techniques called Paired     Associative Stimulations (PAS) involving the integration of afferent sensory inputs at the     level of the ipsilesional primary motor cortex were developed in healthy subjects. PAS     techniques have shown a gain of corticospinal excitability by such phenomenon known as long     Term Potentiation (LTP) and a gain of motor performance. The investigators would like to     propose to evaluate two types of these techniques with a volley of visual afferents     (visuomotor stimulation, V_PAS) or of cerebellar afferents (CER_PAS), because these two     structures convey important information in the execution of the movement.      Design Multicenter, randomized, study, 60 patients in 3 parallel groups (V_PAS, CER_PAS,     control group with sham and sham V_PAS CER_PAS), 5 days of treatment, clinical assessment,     electrophysiological and MRI before, immediately post- and second post-assessments (4 weeks).      A group of 24 healthy subjects will undergo a parallel physiopathological study on the     underlying mechanisms of cerebellar PAS      Objectives Main objective: To determine whether (and how) Paired Associative Stimulation     technique (PAS) induces cerebral reorganization in the primary motor cortex compared to the     control group.      Aim 2: Determine whether (and which) type of PAS is capable of inducing changes in motor     performance of the upper limb paresis and duration Aim 3: Determine whether (and which) type     of PAS is capable of inducing changes in excitability of the corticospinal tract and duration     Aim 4: Determine how PAS techniques modify the functional connectivity during movement Aim 5:     Determine if connectivity changes during induced movement correlate with clinical     improvements Aim 6: Determine whether patients who benefit of a type of PAS have specific     anatomical lesion characteristics (volume, afferent and efferent white matter fasciculi     integrity)   "
254834|NCT02273076|"     The current surgical procedure for breast diseases places an emphasis on the conservation of     breast skin in order to provide more optimal reconstruction.      The purpose of this study is to use portable, non-contact optical imaging device developed at     the Beckman Laser Institute called Spatial Frequency Domain Imaging to detect the changes in     a skin during reconstructive surgery procedure and healing process.   "
254835|NCT02282020|"     Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum     based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA)     mutated ovarian cancer who have progressed at least 6 months after the last platinum based     chemotherapy. Patient should have received at least 2 prior lines of platinum based     chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.   "
254841|NCT02264288|"     The PDA-002-DFU-002 trial is a Phase 2, multicenter, randomized, double blind, placebo     controlled, dose range finding study. The study will enroll approximately 133 subjects in     four treatment groups. The primary objective of the study is to assess the efficacy and     safety of PDA-002 administered intramuscular (IM) in subjects who have DFU with and without     PAD. The secondary objective is to explore potential clinical efficacy by assessing changes     in vascular parameters such as Ankle-Brachial Index and Toe-Brachial Index (ABI and/or TBI),     Transcutaneous oxygen measurements (TcPO2).   "
254842|NCT02261649|"     The purpose of the study is to evaluate how cerebellar resection surgery may affect pain     sensation and the way the brain reads pain signals. By measuring brain activity in children     and adolescents following surgery, the investigators hope to gain valuable information about     pain processing in the brain.   "
254843|NCT02253264|"     Multiple sclerosis (MS) is a chronic inflammatory disorder affecting the central nervous     system that is characterized pathologically by focal demyelinating lesions in the brain     parenchyma. Meningeal inflammation in MS was first noted in 2004. Ectopic lymphoid follicles     were described in the meninges of patients with secondary progressive MS (SPMS) and were     thought to correlate with cortical lesions and atrophy (a surrogate marker for disability).     Subsequently, inflammation in the meninges has been described in primary progressive MS     (PPMS) as well as early relapsing MS.      The ectopic lymphoid follicles are composed of B-cells, T follicular helper cells and     follicular dendritic cells. Rituximab is a monoclonal antibody against CD-20 (a B-cell     marker) that is FDA approved for the treatment of various lymphomas. Intrathecal (IT)     rituximab administration has been used in central nervous system (CNS) lymphoma to achieve     greater cerebrospinal fluid (CSF) concentrations of rituximab. In MS, IT administration of     rituximab could lead to higher CSF rituximab levels resulting in the disruption of meningeal     ectopic lymphoid follicles, ultimately reducing cortical lesions and possibly disease     progression.      The investigators hypothesize that IT rituximab therapy in patients with progressive forms of     MS could disrupt ectopic lymphoid follicles in the meninges and thus slow progression of the     disease, which is particularly important because there exist no FDA-approved therapies for     progressive MS. The investigators hypothesize that using magnetic resonance imaging (MRI) to     identify those with enhancing meningeal lesions will provide a biomarker to select patients     who might be most likely to respond to IT rituximab and to use these lesions to monitor     therapeutic response.      The primary aim of this study is to assess the safety of intrathecal administration of     rituximab in patients with progressive MS. The secondary aims are to evaluate if IT rituximab     leads to a decrease in the quantity of meningeal lesions on MRI or to changes in biomarkers     of inflammatory activity or neuronal injury in the CSF.   "
254844|NCT02249182|"     This study will have two parts as follows:      The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and     confirm the dose of ledipasvir/sofobuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis     C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the     safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in     HCV-infected pediatric participants.      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate     LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover     into the Treatment Phase with no interruption of study drug administration. The Treatment     Phase will evaluate the antiviral efficacy, safety, and tolerability of LDV/SOF FDC +/-     Ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV.   "
254846|NCT02241369|"     This is a Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity     of INO-3106 alone or in combination with INO-9012 DNA vaccines delivered by Electroporation     to subjects with HPV6 associated aerodigestive precancerous lesions and malignancies.   "
254847|NCT02237313|"     The bullous pemphigoid treatment is based on corticosteroids continued for several years.     Pemphigus causes some patients a psychological impact and sometimes major vulnerability that     can occur not only at diagnosis but also at later stages of disease progression. Our     hypothesis is that these episodes of vulnerability may be under four kinds of factors that     may be connected to the plurality of the history of these patients, and the resources they     can mobilize throughout this experience, generating inequality in management and work     around the disease.   "
254848|NCT02232282|"     The investigators central hypothesis is that women with Interstitial Cystitis/Painful Bladder     Syndrome (IC/PBS) will benefit from acupuncture compared with sham treatment and acupuncture     responders will have a differential urinary microbiome.   "
255057|NCT00900419|"     RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with     dysplasia or cancer and from normal volunteers may help doctors identify and learn more about     biomarkers related to cancer. It may also help the study of cancer in the future.      PURPOSE: This laboratory study is looking at biomarkers in patients with respiratory tract     dysplasia or lung cancer, head and neck cancer, or aerodigestive tract cancer and in normal     volunteers.   "
254851|NCT02210728|"     The purpose of the project is to evaluate the efficacy of cognitive behavioral therapy (CBT)     for adults with attention deficit hyperactivity disorder (ADHD) with and without stimulant     medication and compare it to medication alone. Subjects will be randomly assigned to     stimulant medication only, CBT only and combined CBT and stimulant medication group. Patients     will be evaluated at baseline, following mediation optimization (for medicated groups),     following 12 months of treatment, after 3 months of follow up, and after 6 months of follow     up. The investigators hypothesize that the combined group will have the best outcome at all     evaluation points. ADHD in adults is associated with significant morbidity and impaired     academic, occupational, social, and emotional functioning. Developing optimal treatment     approaches for this population is key in improving their functioning.   "
254852|NCT02223364|"     The purpose of this study is to find a better way to make patients comfortable after their     knee surgery. The investigators compared three ways of providing pain relief, either by use     of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the     surgical joint area with one of two different medicines, either ropivacaine or liposomal     bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic     nerve areas would result in lower pain scores and opioid consumption than either of the two     injections in the surgical joint area.   "
254857|NCT02588053|"     Primary Aims: To determine how effective long term Natalizumab (NTZ) therapy is in slowing     the progression of whole brain atrophy. Whole brain atrophy rates will be measured through     magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis     (MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy     controls. The primary outcome will be whole brain atrophy rate measured as the percent change     in brain volume (PBVC) over a two-year period.      Primary hypothesis:      The investigators hypothesize that long term (>2 years) NTZ therapy will slow the rate of     whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change     in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a     true disease activity free state).   "
254859|NCT02423603|"     Normally, cells in human body divide in an orderly way. However in cancer cells, some     important proteins, which help control cell growth, start to behave abnormally resulting in     faster growth and multiplication. In this study, we are looking at a protein called AKT that     helps the cancer cells to develop. Blocking the action of AKT with a drug like AZD5363 may     slow down or stop the cancer growing. The development of AZD5363 is intended to provide a new     treatment option for patients with cancer. The standard chemotherapy agent, Paclitaxel, is     given to destroy cancer cells. AZD5363 may also make the cancer more sensitive to Paclitaxel     and so make this agent more effective.      A gene called PIK3CA has an important relationship with AKT. In tumours where this gene has     been altered, or said to have 'mutated', the response to AZD5363 may be better. PIK3CA     mutations are found commonly in breast cancers, and we will test for the presence of these     mutations in both blood and tumour tissue samples that we ask you to provide. This study will     also look at the relationship between tumours with PIK3CA mutations and the effect of the     treatment.   "
254860|NCT02180165|"     The primary objective of this study is to assess and compare the safety of posaconazole with     voriconazole in Japanese participants with Aspergillosis.   "
254862|NCT02186418|"     The purpose of this study is to determine whether transfer of a fetal hemoglobin gene using a     lentivirus vector (gene transfer) into human blood making cells is safe and feasible in     patients with sickle cell disease.   "
254863|NCT02190292|"     Background: Obsessive-compulsive disorder (OCD) is considered one of the most debilitating of     the psychiatric illnesses, yet much remains unclear regarding causes and cures. A diagnostic     subgroup with acute onset of obsessive-compulsive symptoms (and sometimes tics or anorexia     nervosa) possibly due to an autoimmune response, has been entitled Pediatric Acute onset     Neuropsychiatric Syndrome (PANS). PANS is sometimes treated with immunomodulatory therapy or     antibiotics, with a variable outcome. A diagnosis of PANS is supported by elevated levels of     auto-antibodies and antibody-enzyme activity measured with the Cunningham panel, but the     relationship between these biomarkers and the patients' symptoms remains unclear. A clinician     rated symptom scale for PANS (the PANS scale) has been developed, but needs to be further     evaluated regarding sensitivity and specificity.      Aims:        -  To assess a Swedish cohort of patients diagnosed with PANS and compile their psychiatric          health status, biomarkers, psychiatric symptoms, soft neurological signs and treatment          outcomes in a systematic way        -  To compare psychiatric health status, biomarkers and psychiatric, neurologic and motor          symptoms in this PANS cohort with a control group of psychiatric patients and with          healthy children.        -  To evaluate the Cunningham panel as a diagnostic tool for PANS.        -  To evaluate a clinician rated symptom scale (the PANS scale) as a diagnostic tool for          PANS.      Method: Observational study Participants: Patients (n≈150) who have been tested with the     Cunningham panel of PANS biomarkers in Sweden (or Swedish patients tested in Denmark) will be     asked to participate.      Procedure: Assessment of current symptoms, psychiatric health, neurological and motor     symptoms and possible biomarkers for PANS will be collected for all patients. Retrospective     assessment through interview and medical records, including results from the first assessment     with the Cunningham panel of PANS-biomarkers is made with all patients. 50 out of the total     PANS cohort of 150 patients will be re-tested with the Cunningham panel. A control group     consisting of psychiatric patients (n=60) and healthy children (n=25) will be examined with a     similar test battery and signs and symptoms will be compared with the PANS group.      Significance:      Previous and current symptoms of PANS, levels of PANS biomarkers and treatment outcome will     be investigated, thus knowledge regarding long-term outcome and evidence for the use of     clinical assessment tools and biomarkers for diagnosing PANS will be gained.   "
254865|NCT02157974|"     Women with polycystic ovarian syndrome (PCOS) have increased rates of hepatic steatosis     compared to weight similar women with regular menses. It is unclear if this is related to     high testosterone or insulin resistance. We will assess hepatic glucose release, rates of     lipolysis and hepatic de novo lipogenesis in the fasted and postprandial state to determine     if alterations in the processes contribute to hepatic steatosis. Subjects will be overweight,     sedentary girls with or without PCOS who are not receiving medical therapy for insulin     resistance, or PCOS.   "
254869|NCT02172911|"     This is an open-label study to evaluate the safety, tolerability, and immunogenicity of     INO-3112 DNA vaccines delivered by Electroporation to female subjects with HPV-16 and/or     18-positive cervical carcinoma.   "
254907|NCT02019420|"     This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3     study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days versus     linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the treatment of     ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia     (HABP) or ventilator-associated bacterial pneumonia (VABP). Participants with concurrent     gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm.      Approximately 300 sites will participate. Ventilated participants with HABP/VABP caused by     presumed gram-positive pathogen(s) at baseline, as determined by positive Gram stain, will be     randomized 1:1 to study drug treatment.   "
254873|NCT02130466|"     This is a 5-part dose-finding and preliminary efficacy study of pembrolizumab (Pembro) +     dabrafenib (D) + trametinib (T) for participants with advanced melanoma. Parts 1 and 2 are     open-label to find and confirm the maximum tolerated dose (MTD)/maximum administered dose     (MAD) for Pembro+D+T. The primary hypothesis (Parts 1 and 2) is that Pembro+D+T is     sufficiently well-tolerated to permit clinical investigation. Part 3 is a double-blind study     of Pembro+D+T versus placebo+D+T. The primary study hypothesis (Part 3 only) is that the     Pembro+D+T improves progression-free survival (PFS) compared with placebo+D+T. Part 4 is     nonrandomized and open-label and is designed to evaluate the safety and tolerability and     identify the MTD or MAD of Pembro+T in participants who have v-raf murine sarcoma viral     oncogene homolog B1 [BRAF] mutation-negative (without V600 E or K) melanoma or solid tumors     [irrespective of BRAF status]. The primary hypothesis (Part 4) is that Pembro+T is     sufficiently well-tolerated to permit clinical investigation. Part 5 will confirm the dose(s)     identified in Part 4 in participants BRAF wild type [without V600E or K] melanoma or solid     tumors [irrespective of BRAF status] and will further evaluate the safety and preliminary     efficacy (Objective Response Rate [ORR]) of Pembro+T in participants who have BRAF wild type     [without V600E or K] melanoma only. The primary hypotheses (Part 5) are that Pembro+T is     sufficiently well-tolerated at the MTD/MAD to permit further clinical investigation and is     effective in attaining objective responses based upon Response Evaluation Criteria in Solid     Tumors (RECIST) version 1.1 by Investigator review in participants who have melanoma without     BRAF V600 E or K mutations.      Parts 1 and 2 of the study will also explore the MTD/MAD for open-label Pembro+T (for BRAF     mutation-negative participants) concurrently with the Pembro+D+T arm; Pembro+D (for BRAF     mutation-positive participants).   "
254875|NCT02120014|"     The primary hypothesis is that patients with HFREF (heart failure with reduced ejection     fraction) will demonstrate a markedly expanded intravascular volume which will correlate with     elevated right heart hemodynamics and increased venous capacitance parameters, whereas     patients with HFPEF(heart failure with preserved ejection fraction) will demonstrate     euvolemia to mild volume expansion and a lack of correlation with hemodynamic and venous     compliance parameters.   "
254876|NCT02117635|"     The primary aim of this Phase II trial is to determine whether it is sufficiently likely that     CTX DP treatment at a dose level of 20 million cells improves the recovery in the use of the     paretic arm in acute stroke patients to justify a subsequent larger prospectively controlled     study.      This study will evaluate the safety and efficacy of intracerebral CTX DP at a dose level of     20 million cells in patients with paresis of an arm following an ischaemic middle cerebral     artery (MCA) stoke. Eligible patients will have no useful function of the paretic arm a     minimum of 28 days after the ischaemic stroke (a modified NIH Stroke Scale (NIHSS) Motor Arm     Score of 2, 3 or 4 for the affected arm).   "
254877|NCT02116582|"     The objective of this study was to evaluate the efficacy and safety of enzalutamide treatment     in patients with progressive metastatic castration-resistant prostate cancer previously     treated with abiraterone acetate.   "
254878|NCT02117934|"     The purpose of the study is to evaluate the safety and immunogenicity of an investigational     hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.   "
254879|NCT02106208|"     Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese     consumption, with potentially important impact on this key industry in Canada. This is in     part due to the commonly accepted notion that saturated fat in the diet, of which cheese     contributes significantly, increases the risk of heart disease. Yet, a rather large body of     recent evidence suggests that saturated fat may have been unfairly demonized and that its     impact on the risk of heart disease may in fact be less important than originally thought.     This concept that dairy fat increases the risk of heart attacks therefore needs to be     revisited, and this is one of the key objectives of this proposed research program.      The proposed research is designed to investigate for the first time if dairy fat improves the     levels of the so-called good cholesterol, a protective risk factor that has been     essentially ignored in the arguments supporting the reduction of saturated fat for heart     health.      Our hypothesis is that consumption of SFA from dairy (cheese) compared with a low fat diet     and diets rich in MUFA and PUFA leads to favorable changes in plasma HDL-C concentrations and     functional characteristics. Consumption of SFA from dairy (cheese) also increases LDL     particle size, reduces inflammation and has no deleterious impact on plasma LDL-C and     apolipoproteins B (apoB) concentrations compared with a low fat diet.   "
254880|NCT02104713|"     This study will determine the safety of allogeneic stem cell therapy from healthy donors, for     2nd degree burn wounds of less than 20% Total Body Surface Area (TBSA), at four different     dose levels.      Clinical evaluation will take place every 1 to 4 weeks intervals until wound closure, and     then monthly for 6 months following the last administration of MSCs.      Once the safety and dose-response analysis in Phase 1 is completed, an expanded trial will be     initiated to better examine the efficacy of MSC therapy in 2nd degree burn wounds. Phase 1     will establish the maximum safe dose that will be used in the Phase II trial.   "
254883|NCT02101918|"     This phase II trial studies ziv-aflibercept in treating and perfusion computed tomography     perfusion imaging in predicting response in patients with pancreatic neuroendocrine tumors     that have spread to other parts of the body or cannot be removed by surgery. Ziv-aflibercept     may stop the growth of tumor cells by blocking blood flow to the tumor. Diagnostic     procedures, such as computed tomography perfusion, imaging may help measure a patient's     response to ziv-aflibercept treatment.   "
254885|NCT02098343|"     The purpose of this study is to make a preliminary assessment of the efficacy of a combined     APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy     regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer     (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the     combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD     chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological     activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400     patients.   "
254886|NCT02094118|"     This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced     Red Blood Cells reduces pulmonary complications when compared to standard-of-care     Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.   "
254887|NCT02089685|"     This study is being done to analyze the safety, tolerability, and efficacy of treatment for     advanced melanoma (MEL) and renal cell carcinoma (RCC) using combination regimens of     pembrolizumab + pegylated interferon alfa-2b (PegIFN-2b) and pembrolizumab + ipilimumab     (IPI). The primary hypothesis is that these combinations will be sufficiently well-tolerated     to permit continued clinical investigation.   "
254908|NCT02016781|"     This study is designed as a multicenter trial, with biological assignment to one of two study     arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation     (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.   "
255818|NCT02572869|"     The purpose of this study is to assess the functional and esthetic outcomes in patients who     had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the jaw     bone with a bone ( fibula) from the leg at MSKCC between the years 1987 to 2014.   "
254888|NCT02090361|"     In reconstructive surgery , most losses of cutaneous substance require the use of a thin skin     graft . This technique allows epidermization of the defect by applying a thin layer of     autologous epidermis. It does not reconstitute the injured skin. Transplants cause retractile     scars, adherent to the deep plan, that may require revision surgery . Since a decade , dermal     matrices are mainly used in burned skin centers . The collagen -elastin matrix has the     advantage to set up in the same operation that the skin graft and contain elastic fibers ,     two assets which improve the results of skin grafting.      Objective:      Evaluation of the clinical efficacy of the addition of a dermal matrix to skin graft on Skin     Foldability, at day 360.      Methodology:      This is a multicenter randomized study (CHU Caen , Amiens, Rouen and Lille)      Conduct of the study :      The transplant will be performed according to the protocol defined between inter -region     surgeons. The implementation of the dermal matrix will be in the same surgical technique as     thin skin graft ( group 1 ) or the thin skin graft will be performed alone ( group 2) time .      Evaluation Criteria Main : Skin Foldability ( Uf ) assessed grafted site will be compared to     the opposite side ungrafted evaluated at Day 360 . Quantitative data will be measured by a     cutometer Skin Elasticity Meter 580 (Courage and Khazaba Electronic GmbH).      To achieve the main objective, it is planned to compare the ratio between Uf graft site and     the opposite healthy site between two groups: skin + matrix graft , or skin graft only. Thus,     the Wilcoxon test for independent samples will be used to settle bilateral formulation     between the null hypothesis ( there is no difference between the two groups ) and the     alternative hypothesis ( there is a difference between the two groups ) . In determining the     overall risk of first species to 5% and the power of this test to detect the 90% expected     under the alternative hypothesis difference should be the main criterion for evaluating at     least 59 patients in each group so 118 patients total.      Prospect If the contribution of a dermal matrix in loss of skin substances improves skin     pliability and reduces pain , functional and aesthetic sequelae grafts thin skin , the dermal     matrix may be proposed as a complementary treatment in these indications.   "
254889|NCT02081846|"     Home Nurse Visit post discharge.   "
254890|NCT02076204|"     Adverse birth outcomes result in significant emotional and economic costs for families and     communities. Research suggests that poor birth outcomes are influenced by a variety of     social, psychological, behavioral, environmental, and biological factors. Home visiting     programs represent a promising means of impacting each of these areas.      The Mother and Infant Home Visiting Program Evaluation - Strong Start (MIHOPE-Strong Start)     will evaluate the effectiveness of two evidence-based home visiting models at improving birth     outcomes for women who are enrolled in Medicaid or CHIP. The two models to be studied -     Healthy Families America (HFA) and Nurse-Family Partnership (NFP) - have both shown some     evidence of improving birth outcomes in prior research.      The overall goals of the study are to determine whether home visiting programs improve birth     outcomes and reduce health care costs in the child's first year. In addition, the evaluation     is designed to investigate the features of local programs and of home visitation that lead to     greater effects on birth outcomes and health care costs. The study includes an impact     analysis to measure what difference home visiting programs make on maternal prenatal health     and health care use, preterm birth and other birth outcomes, and infant health and health     care use. It also includes an implementation analysis that will describe the families who     participate and examine how the program models operate in their local and state contexts. The     primary data used in the study are expected to be from surveys completed by families and home     visiting staff, Medicaid and CHIP data, vital records, and program service records. Among     families who are eligible for the study, random assignment will be used to select families     for enrollment in home visiting services. Those selected for home visiting services will form     the program group, and those not selected will form a comparison group. The research team     will monitor both groups over time to see if differences emerge in the outcome areas     mentioned above. Although the study will affect which families can enroll in home visiting     services, no fewer families will be served as a result of the study.   "
254891|NCT02075853|"     The Evans calcaneal lengthening is a common surgical correction used for children with     spastic cerebral palsy (CP) and painful flat feet. This procedure involves the insertion of a     trapezoidal bone graft into the calcaneus bone. Both autograft and allografting materials     have been used for this procedure, but both types of grafting materials have associated     limitations. Autologous grafting materials, which are harvested from the iliac crest at the     time of surgery, are associated with high rates of prolonged donor site pain. There is     limited bone available from the iliac crest. For this reason autologous bone grafts are not     commonly used for the Evan's procedure. Cadaver allografting materials are variable in their     mechanical and geometric properties. Recently, xenografting materials have been developed     that have consistent mechanical properties and are available in a larger size that is formed     to fit the individual patient intraoperatively. The purpose of this study is to evaluate the     long term outcomes of the procedure with the different graft options. Another purpose is to     compare the difference in surgical correction obtained with the cadaver allograft and the     xenografting materials. This study will also observe and evaluate a wide range of outcome     variables that encompass multiple levels of patient care, from clinical observation to parent     and patient satisfaction, and compare these with the observed changes in the radiographic and     plantar pressure parameters of the foot. This data will be evaluated pre to post surgery and     for two years of follow-up time. The aim is to uncover the characteristics of collapse     observed with the two different grafting materials.   "
254902|NCT02047721|"     In this study the Investigators are examining the effects of a 12-week exercise program     (intervention) on measures of appetite and food intake regulation in overweight to mildly     obese healthy adults. The Investigators hypothesize that individuals who lose a significant     amount of weight in response to the intervention will show a reduction in the brain response     to food cues as measured by functional magnetic resonance imaging (fMRI) when compared to     those who do not lose weight. These changes in neuronal activity will be associated to     physiologic and behavioral measures.   "
254892|NCT02069782|"     MIHOPE is a multi-state study of home visiting programs authorized under the Maternal,     Infant, and Early Childhood Home Visiting (MIECHV) program. The study is required by the     federal Patient Protection and Affordable Care Act of 2010 (ACA), which created the MIECHV     program. It is being conducted by MDRC under contract to the Administration for Children and     Families within the US Department of Health and Human Services. In conducting the research,     MDRC has subcontracted portions of the research to Mathematica Policy Research, Johns Hopkins     University, Columbia University, University of Georgia, and James Bell Associates.      MIHOPE is seeking to randomly assign about 4300 families nationally to home visiting services     or to a comparison group that will receive referrals to other services in the community. The     study is seeking to include 88 local home visiting programs (sites) that are funded through     MIECHV in approximately 12 states. In Washington, the study plans to randomly assign     approximately 360 families across 6 home visiting program sites. Data will be collected from     families, local home visiting programs, and state and federal administrative data systems to     assess the effects of the programs on family outcomes and to learn more about how the     programs are run. Sites included in the evaluation will be using one of four national service     models (Nurse Family Partnership, Healthy Families America, Parents as Teachers, and Early     Head Start—Home Visiting Option) that states have chosen for most of their MIECHV funding.     MIHOPE will inform the federal government about the effectiveness of the MIECHV program in     its first few years of operation, and it will provide information to help states develop and     strengthen home visiting programs in the future. Research findings will be disseminated     through a report to Congress in 2015; reports on program impacts, implementation, and on the     relationship between program features and program impacts; journal articles; and practitioner     briefs.   "
254927|NCT01962103|"     The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid     tumors, and to see if it works to treat these solid tumors in children and young adults (in     phase 1 ≤ 18 years old and in phase 2 ≤ 24 years old). After the final dose has been chosen,     patients will be enrolled according to the specific solid tumor type, (neuroblastoma,     rhabdomyosarcoma, or Ewing's sarcoma), to see how nab-paclitaxel works in treating these     tumors.   "
254929|NCT01951326|"     The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's     disease.   "
254894|NCT02060760|"     Hypothesis: High sensitivity cTnI assays will have improved diagnostic accuracy for type 1 MI     compared to contemporary cTnI assays.      The primary objective of the study is to determine the performance of a high sensitivity     cardiac troponin I (hs-cTnI) assay compared to a contemporary cTnI assay for the diagnostic     accuracy of type 1 acute myocardial infarction (AMI).      The diagnostic performance of Abbott's hs-cTnI assay will be evaluated. Investigators will     assess the assay's ability to diagnose AMI earlier and to rule out AMI earlier. The     sensitivity, specificity, positive predictive value and negative predictive value of the     hs-cTnI assay will be evaluated with both a universal cut off as well as with gender and     potentially age derived 99th percentile upper reference limits (URL).      Investigators will evaluate delta hs-cTnI values (pre-specified absolute concentration and     percent changes over time) for their ability to contribute to the negative predictive value     and hence potentially lead to an earlier rule out of AMI (improved specificity).     Additionally, investigators will assess delta changes of the hs-cTnI assay for their     potential contribution to the clinical differentiation of type 1 and type 2 (supply demand     mismatch) MIs.      Lastly, investigators will compare the diagnosis of AMI based on the currently used     contemporary assay to the hs-assay, to assess both the incidence of AMI as well as for the     time to diagnosis.   "
254895|NCT02058719|"     This study plans to learn more about pulmonary complications of human immunodeficiency     virus/acquired immunodeficiency syndrome (HIV/AIDS). Even though antiretroviral therapy (ART)     has dramatically decreased the number of opportunistic infections and deaths in HIV infected     patients, pulmonary complications (including chronic obstructive pulmonary disease (COPD)     development and pneumonias resulting in decreased lung function) of HIV/AIDS continue to be a     major cause of morbidity and mortality in this population. The mechanisms underlying the     increased risk of COPD and decreased lung function in HIV infected individuals is not well     understand and needs to be studied.      The investigators hypothesize that the immunoregulatory consequences and immunosuppressive     lung milieu secondary to HIV and cigarette smoke combine to increase the risk of lung     infection and injury in HIV infected smokers, hastening the development of COPD. The     mechanisms will be directly tested using blood and bronchial alveolar lavage (BAL) cells from     smokers and nonsmokers with and without HIV infection.   "
254896|NCT02050035|"     The purpose of this study is to investigate the effects of 12 weeks of aerobic exercise     training on blood vessel function in Stages 1-4 Chronic Kidney Disease.   "
254898|NCT02052167|"     This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent     JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the     Methotrexate Prefilled Pen (including a label comprehension assessment and a device     robustness evaluation).   "
254899|NCT02046746|"     The study objective is to evaluate if a renal specific oral nutrition supplement (ONS) aids     in maintaining nutritional status.   "
254903|NCT02121327|"     It has been reported that stroke is the first cause of becoming bedridden, and its cumulative     recurrence rate in 5 years is approximately 35%. There is a high probability that patients     reduce or discontinue medications by self-determination, leading to a high risk of stroke     recurrence in these patients. Comprehensive and long-term patient educations ameliorating     their self-management are important making patients possible to be managed according to the     guidelines for their risk factors. Using disease management programs created for each of risk     factors according to clinical practice guidelines, the influence of those programs were     evaluated for the prevention of stroke recurrence in this Disease Management Program Stroke     Trial.   "
254904|NCT02029898|"     One of the problems during general anesthesia (GA) for caesarean section is the place of     opioid agents. Indeed, the literature does not provide so far a clear answer regarding the     use of opioids prior to extraction of the newborn. Indeed, if the opioid administration at     induction is beneficial for the mother (better control of autonomic responses to noxious     stimuli), the impact on the newborn can be unfavorable in terms of adaptation to extrauterine     life . This is especially true if the birth takes place in a context of prematurity and / or     acute fetal distress.      The pharmacokinetics of remifentanil make it the only opioid which is consistent with a rapid     sequence induction. Its short period of action avoids the manual ventilation of patients     before intubation, while providing a peak of action concomitant to the nociceptive     stimulation. Patients at high risk of aspiration, including pregnant women, may benefit from     this type of morphine at induction. In addition, the fact that remifentanil seems to be     associated with relative fetal safety in obstetrical or neonatal context legitimized the     development of protocols to study maternal-fetal consequences of the use of remifentanil at     induction of AG for emergency caesarean section.      While cesarean section under general anesthesia mainly concern premature newborns in France,     no work has focused on the use of remifentanil for caesarean section in a context of preterm     without preeclampsia.      The main hypothesis of this study is to evaluate the safety of the use of remifentanil in     terms of adaptation to extrauterine life in children born prematurely by caesarean section     under general anesthesia outside the context of preeclampsia.      To do this, we will compare two groups of children, one consisting of children born by     cesarean section under general anesthesia with maternal remifentanil infusion, the other made     up of children born by cesarean section under general anesthesia without maternal infusion of     remifentanil. This study is prospective, single-center, randomized, double-blinded.      The primary endpoint is formed by the value of the Apgar score less than 7 at 5 minutes,     calculated in the delivery room by the team supporting the child (midwives and     pediatricians).      The secondary endpoints are formed by maternal hemodynamic parameters (SBP, DBP, MAP, HR),     the rate of complications during induction (difficult intubation, aspiration), the onset of     respiratory distress requiring ventilation mask in the newborn, the rate of intubation in     neonates, and the rate of use of adjuvant anesthetic agents.   "
254905|NCT02041468|"     This is a phase IV multicenter trial to evaluate the mechanisms of resistance and     pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a     real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients.      The study will address two anticipated issues surrounding personalized medicine and treatment     with crizotinib:        -  it will enable real-life Heath Economics and Outcome Research (HEOR)        -  it will validate and/or identify new blood-based or tissue-based biomarkers of          resistance to crizotinib.      At least 30 patients will be recruited in Quebec and Ontario for the PE study. Patients will     be asked to complete quality-of-life questionnaires at regular intervals in a real-life     setting of treatment with crizotinib.      Approximately 25 patients will be recruited to the biomarker sub-study in Quebec to     understand resistance mechanisms of crizotinib. In these patients, a biopsy from any     accessible metastatic lesion will be obtained when the patient is no longer responding to     treatment, as well as blood sampling during regular treatment visits.   "
255030|NCT01256268|"     The purpose of this study is to:        -  Test the safety of a new investigational drug called MK-8669 (ridaforolimus)        -  Determine the maximum tolerated dose of MK-8669        -  Determine the effectiveness of the maximum tolerated dose of MK-8669   "
255893|NCT02389075|"     This study plans to learn more about the relationship between systemic autoimmune disease,     such as inflammatory bowel disease and ankylosing spondyloarthritis, bacteria in the colon,     and the changes in colon tissue.   "
254909|NCT02016924|"     The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK)     and confirm the dose of cobicistat-boosted atazanavir (ATV/co) or cobicistat-boosted     darunavir (DRV/co) in HIV-1 infected antiretroviral treatment-experienced, virologically     suppressed, pediatric participants between the ages of 3 months to < 18 years of age.      This study will also evaluate the safety, tolerability, and efficacy of ATV/co or DRV/co each     co-administered with a background regimen (BR) through 48 weeks and during the 5 year     long-term treatment.      There will be 2 parts to the study.        -  Part A: Participants will be enrolled sequentially by age cohort to evaluate the steady          state PK and confirm dose of ATV/co and DRV/co. Following screening, enrolled          participants will continue their suppressive regimen of either ATV/r or DRV/r once-daily          plus their BR. On Day 1, participants will discontinue ritonavir and initiate once daily          cobicistat (COBI) to be taken with their ATV or DRV plus their BR. All participants          enrolled in Part A will participate in an intensive PK evaluation of COBI and ATV or DRV          on Day 10. Following completion of the intensive PK visit, participants will continue to          receive COBI coadministered with DRV or ATV each with a BR and return for scheduled          study visits.        -  Part B: Participants will be enrolled to evaluate the safety, tolerability, and efficacy          of the ATV/co or DRV/co regimen. For all cohorts in Part B, participants will be          screened and initiated sequentially by each age cohort following confirmation of          appropriate COBI exposure and PI exposures from the corresponding age cohort in Part A.   "
254910|NCT02014818|"     To treat patients with stable coronary artery disease, elective percutaneous coronary     intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium     stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard     drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated     by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after stent     placement, along with observation of changes over time in the target vessel. The     relationships between OCT findings and the time course of platelet aggregation and between     OCT findings and the occurrence of major cardio- cerebrovascular events will also be     elucidated.   "
254911|NCT02012309|"     HIV infection is complicated by high rates of infections and cancers which are often the     cause of death rather than the HIV/AIDS virus itself. Treatment of HIV with antiretroviral     medications has decreased the frequency of many complications by over 90%, but bacterial     pneumonia remains extremely high. Current vaccines are not very effective in preventing these     infections in patients with HIV infection. The investigators are studying the cells (B cells)     that make antibodies to fight infection by binding to and killing bacteria. The goal is to     understand how HIV impairs the ability of B cells to make antibodies in sufficient quantity     and of sufficient quality to protect patients with HIV to learn how to enhance protection     against these infections. The investigators also seek to understand the role of the bacteria     (specifically Streptococcus pneumoniae) that normally live in the nose and throat in the     development of pneumonia and other infections.   "
254916|NCT01999751|"     This study is a prospective, non-randomized, unblinded case series of patients with permanent     pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic     resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Patients     will be enrolled over a 60-month period and followed for 12 months, with data collected to     evaluate the study's primary endpoint, change in pacing thresholds over time, as well as a     series of secondary endpoints, including: adverse events, symptoms, need to make pacemaker     programming changes, and possible artifacts created by the pacemaker systems on the MRI     scans. This study will allow for carefully monitoring of the safety MRI scanning in this     population and improve practice models and protocols in the future.   "
254917|NCT01996865|"     Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are     distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with     direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent     studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus     rituximab (R2), supporting further study of this combination.   "
254919|NCT01997333|"     The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an     antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative     Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB),     which CDX-011 binds to. The study will also further characterize the safety of CDX-011     treatment in this patient population.   "
254921|NCT01984658|"     This study is a prospective open phase-I study to investigate the safety and tolerability for     administration of repeated doses of ALECSAT.      Each patient will be followed up to 24 weeks from the initial blood donation to the last     visit. However, the actual treatment starts on day 26, when the first single dose of ALECSAT     is administered. The following administrations are given with 3 weeks intervals, i.e. at week     7 and 10. The patients are attending Kirurgisk afdeling K, Bispebjerg Hospital, and are     followed by close examinations during the study period and at regular visits after completing     the study as advised by the patient's responsible physician.   "
254924|NCT02010593|"     This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4     weeks in postmenopausal women over 12 weeks of product use.   "
254926|NCT01960257|"     This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin),     which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect     information about patients taking their TB medications. The wearable sensor records     information, which is uploaded wirelessly to a mobile device and then to a secure computer.     Together the sensors and the mobile device transmitting the information to the study computer     are called a digital health feedback system (DHFS), which gives healthcare providers     information about when patients have taken their TB medications. The advantage of the DHFS is     that patients can take their medication where and when it is convenient for them, and do not     have to wait for a nurse to directly observe them taking their medication.      The purpose of this study is to find out if using these new technologies works as well as the     standard method of observing in person when patients take their TB medications. This study     will also look at the costs of using a DHFS for TB medications, what patients and healthcare     providers think about using it, and other factors that can determine when one approach works     better than another.      This study has two parts. For the first part of the study (Step I), patients will have an     initial screening visit and then, in one two-week period, they will have 4 study visits at     the UCSD AntiViral Research Center (AVRC) and routine visits from Public Health Services     (PHS) workers. This part of the study is designed to confirm that the DHFS is working     correctly and is accurately collecting information about each dose of medication that     patients take, and to understand what patients and healthcare providers think about using the     DHFS.      If patients are eligible for the second part of the study (Step II) and want to continue,     that will last another 8-14 weeks with an additional 4 study visits at the AVRC. In the     second part of the study, patients will be randomized into one of the following two groups.      Group 1: TB treatment is monitored by continued use of the DHFS      Group 2: TB treatment is monitored by the standard methods used by PHS (DOT)      The second part of the study is designed to compare these two methods of observing patients     taking their TB medications, what the relative costs of these methods are , and the     perception by patients and/or healthcare providers of the ease of use of the novel     technology.   "
254930|NCT01951339|"     The goal of this study is to examine whether sitagliptin, an agent which enhances the action     of hormones that control the release of insulin and is already in clinical use for type 2     diabetes, might also improve functional exercise capacity.      Specific aims:      1. To test whether sitagliptin will improve functional exercise capacity in persons with type     2 diabetes compared to glimepiride.      1a. The primary outcome will be peak oxygen consumption (VO2peak) and oxygen uptake kinetics     (VO2 kinetics).      1b. Secondary outcomes include cardiac function, endothelial function and tissue oxygen     saturation (STO2) as well as health-related quality of life.      2. To evaluate the impact of sitagliptin on muscle mitochondrial function 2a. The primary     outcome to address this aim will be 31P measurements (phosphocreatine, free inorganic     phosphate, adenosine triphosphate peaks, adenosine diphosphate and pH)      Impact: Novel approaches are needed to decrease excess cardiovascular morbidity and mortality     in diabetes. Diabetes impairs cardiovascular fitness and thereby mortality. A demonstration     that sitagliptin improves cardiovascular fitness, (and possibly mitochondrial function) will     provide important new data pertinent to the management of diabetes and pre-diabetes.   "
254932|NCT01946477|"     This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and     low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) ,     daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed     or refractory multiple myeloma who have received a first or second line treatment of     lenalidomide-based therapy.      This trial will test the hypothesis for Cohort A that the proportion of patients will have an     Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in     pretreated patients who are refractory to lenalidomide.      This trial will test the hypothesis for Cohort B that the proportion of patients will have an     Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in     pretreated patients who are refractory to lenalidomide.   "
254933|NCT01945281|"     The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared     with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and     infants. The primary hypothesis to be tested in the study is that caspofungin will be     superior to amphotericin B deoxycholate with regard to the proportion of participants with     fungal-free survival at the 2-week posttherapy follow-up visit.   "
254936|NCT01939769|"     Background:      - Research has shown that one exercise session may improve a person s ability to recall     information they learned before the exercise. Knowing how exercise changes brain activity to     improve memory can help researchers understand how memory works and how to improve it in     people with memory problems. This study compares two kinds of exercise on a stationary bike     for their ability to temporarily improve memory on certain tests. Researchers will look at     the effect of exercise on body chemistry by drawing blood and collecting saliva.      Objectives:      - To understand how a single session of exercise affects memory testing in healthy people and     people who have had traumatic brain injury (TBI).      Eligibility:        -  Adults ages 18 through 45 with TBI.        -  Healthy adult volunteers, ages 18 through 45.      Design:        -  Participants will be screened with medical history and physical exam. This will take          about 1 hour.        -  Participants with TBI will also be screened with a test of their memory. This will take          another hour.        -  Visit 1 will take about 3 hours. Participants will:      <TAB>- Have a tube inserted in their arm for drawing blood during the tests.      <TAB>- Take memory tests. They will look at pictures, symbols, and words, then answer     questions.      <TAB>- Give a saliva sample by chewing on a small sponge for 2 minutes.      <TAB>- Exercise on a stationary bike.      <TAB>- Take the memory tests again.      - Visit 2 will take place 1 week later. Participants will take the memory tests only.   "
254939|NCT01930214|"     The objective of this study is to assess the current standard of care treatment outcome in     none/mild, moderate and severely calcified coronary lesions using:        -  A composite of MACE at 30-day and one (1) year post procedure, and        -  Procedural and lesion success   "
254941|NCT01920932|"     This pilot phase II trial studies how well giving brentuximab vedotin, combination     chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB     or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer     growth in different ways. Some block the ability of cancer to grow and spread. Others find     cancer cells and help kill them or carry cancer killing substances to them. Drugs used in     chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and     dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     cancer cells. Giving brentuximab vedotin with combination chemotherapy may kill more cancer     cells and reduce the need for radiation therapy.   "
254952|NCT01873326|"     The purpose of this study is to learn about the safety and effectiveness of two different     drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT).     One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The     other combination of drugs, bleomycin, etoposide and cisplatin (BEP), is the standard of care     treatment for intermediate- and poor-risk germ cell tumors. However, BEP does not cure every     patient and therefore newer treatments are needed.   "
254942|NCT01915238|"     Background:      - The Age-Related Eye Disease 2 Study (AREDS2) looked at two eye diseases. These were     age-related macular degeneration (AMD) and cataracts. Participants in that study took     supplement pills and some participants had additional pictures taken of their eyes. That     study is now over. Researchers want to do a follow-up study after participants finish taking     the pills, to see if they cause long-term effects on AMD. This study will be combined with     follow-up visits of the AREDS2 study if possible.      Objectives:      - To learn more about the effect of oral supplements on AMD.      Eligibility:      - People who completed the AREDS2 study.      Design:        -  Participants will have up to 2 study visits over 6 18 months.        -  Each visit will last up to 5 hours. The visits will be combined with annual follow-up          visits in the AREDS2 study if possible.        -  At each visit, participants will undergo an eye exam and photography.        -  The eye exam includes testing sight, measuring eye pressure, and checking eye movements.          To examine the inside of the eye, the pupil will be dilated with eye drops.        -  Photographs of the inside of the eye may be taken during the eye exam and while the eyes          are dilated.        -  A contact lens may be placed on the eye briefly to look at the retina at the back of the          eye.   "
254944|NCT01904188|"     The aim of this project is to test the utility of the Gene-Z device on clinically obtained     bodily fluid samples taken from patients with suspected sepsis based on having three of four     positive Systemic Inflammatory Response Syndrome markers. Specimens will be collected by     Sparrow Laboratories and McLaren Greater Lansing laboratories, processed and stored for     analysis at a later date to determine if the microbial pathogens identified by current     methods of culture, as well as pathogen susceptibility to antibiotics by culture results, can     be identified by the GeneZ technology accurately. It will not affect current patient care nor     impact patient care, which will continue in the standard fashion today for sepsis. Results     will be compared to standard culture results and antibiotic sensitivities.   "
254948|NCT01890421|"     Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs     and/or symptoms, will be invited to participate in the study. The duration for a subject in     the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be     required.      This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic     Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion     (specificity ) of coronary artery disease utilizing a uniform image acquisition software. The     CMR images will be tested either against the results from routine clinical Coronary     Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the     standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment     or be scheduled up to 4/6 weeks after the study.      CMRI and CA/CTA images will be collected for an independent image review (blinded read).   "
254950|NCT01889394|"     To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing     following excision of a pilonidal sinus.   "
254955|NCT01856907|"     Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with     onset or first recognition during pregnancy. GDM is one of the most frequent metabolic     disorders occurring during pregnancy. Approximately 7% of all pregnancies in the United     States are complicated by gestational diabetes resulting in more than 200,000 cases annually.     There is epidemiologic evidence associating GDM with insulin resistance, glucose intolerance,     and type 2 diabetes (DM2). Among all the risk factors of diabetes mellitus, the experience of     gestational diabetes is the strongest one. Systematic reviews of older studies conclude that     35-60% women with gestational diabetes will develop type 2 diabetes at rates much greater     than control groups who did not have glucose intolerance during pregnancy. Studies are needed     for optimal postpartum and long-term health of women who have had GDM. Recent evidence     suggests that incretin-based therapies may be useful for the treatment of DM2 because     continuous administration of glucagon-like peptide 1 (GLP-1) produces substantial     improvements in glucose control and ß-cell function in subjects with DM2. Inhibition of     dipeptidyl peptidase-4 (DPP-4) increases the concentration of GLP-1 and may potentially delay     disease progression in GDM considering the ß-cell function improvement in DM2 and ß-cell mass     shown to increase in animal models. This study will examine if combination sitagliptin (a     DPP-4 inhibitor)-plus metformin is more effective than metformin alone or placebo in     improving metabolic parameters, specifically the impact on β-cell function, in prior GDM     women with glucose abnormalities.   "
254956|NCT01850927|"     Recent data suggests that subclinical myocardial injury occurs in patients undergoing major     abdominal surgery, and the degree of damage is proportionally linked to morbidity and     mortality in the short and medium terms. Therefore, new methods of limiting myocardial damage     are urgently needed.      Ischemic preconditioning is a phenomenon whereby a brief non-lethal ischemia-reperfusion     stimulus gives a protective effect to further ischemic insults. In remote ischemic     preconditioning (RIPC), this initial stimulus is carried out away from the region of     interest, normally a limb. In meta-analysed syntheses the effect size of RIPC in reducing     cardiac damage during bypass grafting, as characterised by troponin release, seems to be     about 35%.      The PRIME Study will assess the value of RIPC in reducing subclinical myocardial injury in     patients undergoing major abdominal surgery. Post-operative troponin release will be used as     a surrogate marker of myocardial damage. There is no good data on which to build a reliable     sample size calculation, therefore we estimated samples sizes using supplementary data from     the recent VISION study. The investigators intend to build a clinically powered study from     the results of this study.      Study design will be by single-centre single-blind randomised control trial. Allocation will     be 1:1. All treatments will be carried after induction of anaesthesia, prior to surgery. In     the RIPC-treatment group, a blood pressure cuff inflated on an upper limb to 200mmHg for 5     minutes, and then deflated for 5 minutes, repeated in three cycles. In the control group, the     blood pressure cuff will not be inflated, but the patient will remain under anaesthesia for     the same amount of time.      Primary endpoint will be peak post-operative 5th generation hs-TnT (highly sensitive     Troponin-T, ng/ml). Secondary endpoint will be hs-TnT area-under-the-curve, major adverse     cardiovascular events, serious surgical complications, non-cardiovascular death, quality of     life, and length of stay.   "
254957|NCT01847001|"     This study is being conducted in patients with newly diagnosed breast cancer that will be     undergoing chemotherapy prior to surgery - neoadjuvant chemotherapy. The study involves     treatment with standard chemotherapy and a commonly used, FDA-approved, blood pressure drug     called propranolol (Inderal). The purposes of this study are to:        1. Determine the effect of propranolol plus chemotherapy on breast cancer cells as well as          the growth of blood vessels surrounding breast cancer cells.        2. Determine the side effect profile of propranolol and chemotherapy in patients with          breast cancer receiving neoadjuvant chemotherapy.      This research is being done because previous laboratory work has shown that propranolol may     decrease the ability for the blood vessels around breast cancer cells to grow, which may be     important in helping cancer cells grow. It also may reduce the likelihood for breast cancer     cells to spread. If changes are seen in the breast cancer cells and surrounding blood vessels     in this study, we will pan to evaluate whether propranolol decreases the likelihood of breast     cancer from recurring in future, later studies. All chemotherapy regimens used in this study     have been the standard of care for many years; however, the use of propranolol is being     researched along with the chemotherapy regimens.   "
255144|NCT03269188|"     prospective cohort study of women who underwent caesarean section in mulago hospital.     followed up for 2 months and assessed for development of persistent post operative pain at     the incision site and its effect on quality of life. incidence of persistent postoperative     pain and associated factors determined.   "
254962|NCT01805024|"     The purpose of the study is to establish the pharmacokinetic profile of omigapil in     paediatric and adolescent patients with CMD and to evaluate the safety and tolerability of     omigapil.      Funding source - FDA OOPD   "
255058|NCT00897364|"     RATIONALE: Studying samples of tissue from smokers and non-smokers in the laboratory may help     doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This phase II study is looking at biomarkers in the nose, throat, and lung tissue of     smokers and non-smokers.   "
254963|NCT01810003|"     Subclinical inflammation is now indisputably recognized as a key etiological factor in the     development of atherosclerosis and subsequent cardiovascular disease. Obesity and related     dysmetabolic states including metabolic syndrome (MetS) are highly prevalent causes of     subclinical inflammation. Obesity and MetS are both diet and lifestyle-related and there is a     growing body of literature suggesting that specific nutrients, such as long chain omega-3     polyunsaturated fatty acids (LCn-3PUFA), may attenuate the pro-inflammatory state associated     with these conditions. However, careful review of existing literature on this topic reveals     important gaps in knowledge, the purported anti-inflammatory effects of LCn-3PUFA even being     questioned by many. Significant confounding attributable to study design, sample size and     biomarker selection may be responsible in part for inconsistencies in the literature on     LCn-3PUFA and inflammation. We also found that evidence available to date (for and against)     is based primarily on secondary analyses, as most of the studies published were not primarily     designed to investigate inflammation as a primary outcome. It remains unclear whether the     different LCn-3PUFA, primarily docosahexaenoic acid (DHA, 22:6n-3) and eicosapentaenoic acid     (EPA, 20:5n-3), have similar effects on pro-inflammatory processes as almost all studies were     undertaken using a mix of LCn-3PUFA. Whether efficacy of EPA and DHA is influenced by     sex/gender is also unknown. Finally, a better understanding of the systemic and     tissue-specific mechanisms underlying the anticipated anti-inflammatory effects of different     LCn-3PUFA in MetS would also be of great value. Addressing these gaps has important public     health implications, considering that LCn-3PUFA supplements are broadly and indiscriminately     recommended for the prevention of cardiovascular disease.      The overarching objective of the proposed research is to compare the anti-inflammatory     effects of EPA and DHA in men and women with MetS.   "
254989|NCT01647321|"     Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for     which there are no existing therapies that alter the disease course. This research will     utilize cutting edge functional electrical stimulation (FES) cycling technology with the goal     of improving walking in individuals with SPMS. The investigators hypothesize that FES cycling     will improve walking in subjects with SPMS.   "
254969|NCT01782131|"     The purpose of this study is to evaluate the safety and efficacy of posaconazole versus     voriconazole in the treatment of adults and adolescents with invasive aspergillosis (IA).   "
254971|NCT01771471|"     This is a clinical study to collect safety and preliminary efficiency information on the use     of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to     treat low back pain.   "
254972|NCT01762332|"     In our previous study, NCT01631695, we proposed and clinically evaluated the Medasense pain     response index, PRI, in anesthetized patients undergoing surgery. Note: the name PRI has been     changed to NoL (Nociception Level) Index.      The PRI is based on a non-linear combination of several pain-related physiological parameters     into a one unique index (0-100).      In this study we aim to validate the performance of the PRI by:        1. investigating the patient's PRI response to surgical painful stimuli under different          levels of analgesia:             -  Investigating patient's PRI response to surgical painful stimuli under two               different levels of Remifentanil Target Control Infusion (TCI) rates.             -  Investigating patient's PRI response to standardized painful stimulus (Tetanic               stimulus) with and without opioids.        2. investigating the effect of beta-blockers on PRI performance in patients taking chronic          beta-blocker treatment.      The study is based on recording and analyzing the subject's physiological signals, while     recording painful events, medication dosing and different clinical signs.   "
254974|NCT01793909|"     This study plans to learn more about the effects of type 2 diabetes (T2DM) on exercise blood     flow and muscle oxygen uptake. This study will evaluate & compare exercise function during     single leg plantar flexion exercise in a total of 45 subjects from the Denver area (15 lean     controls, 15 people with T2DM, and 15 overweight control subjects).      Differences between the exercise responses in people with T2DM and healthy people will help     further identify the disease process of T2DM and direct future research of treatments and     interventions.   "
254978|NCT01728038|"     An estimated 6.6 million parents who smoke visit pediatric emergency departments (PED)     annually. Up to 50% of these parental smokers are from low-income, racially/ethnically     diverse households in which a variety of tobacco-related disparities (TRD) exist for both the     parents and their children. The PED is an ideal setting in which to address these     disparities, which include differences in tobacco use, pediatric second hand smoke exposure     (SHSe), quit rates, access to cessation resources, and morbidity such as cancer. The team has     conducted the only two small-scale randomized control trials (RCTs) investigating the     efficacy of providing smoking cessation counseling to parents in the PED setting. This     previous research indicates that parental smokers who visit the PED are aware of the     pediatric effects of SHSe, motivated to quit, eager to receive cessation counseling in this     setting, and show trends towards quitting.      Parents with children who have a SHSe-related illness will have higher prolonged abstinence     and point prevalence cessation rates, higher motivation to quit, greater number of quit     attempts, and lower child SHSe compared to those parents who have a child with a     non-SHSe-related illness at baseline.   "
254981|NCT01711515|"     This phase I trial studies the side effects and best dose of ipilimumab when given after     chemoradiation therapy in treating patients with stages IB2-IIB or IIIB-IVA cervical cancer.     Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink     tumors. Monoclonal antibodies, such as ipilimumab, may find tumor cells and help carry     tumor-killing substances to them. Giving ipilimumab together with chemoradiation therapy may     be a better way treat cervical cancer.   "
254983|NCT01682083|"     This is a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with     trametinib versus two placebos in the adjuvant treatment of melanoma after surgical     resection. Patients with completely resected, histologically confirmed, BRAF V600E/K     mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc]     cutaneous melanoma will be screened for eligibility. Subjects will be randomized to receive     either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily     [QD]) combination therapy or two placebos for 12 months.   "
254984|NCT01680965|"     To study the safety and side effects of Ofatumumab in the treatment of chronic     graft-versus-host disease (GvHD). This study will also evaluate effectiveness of Ofatumumab     when added to standard steroid treatment for chronic graft-versus-host disease   "
255059|NCT01136447|"     The purpose of this study is to determine whether ultrasound guidance or nerve stimulation is     the best option for placing continuous peripheral nerve block catheters for upper limb     surgery.   "
255060|NCT00877903|"     The objective of the present study is to establish the safety and efficacy of Prochymal®     following first acute myocardial infarction.   "
254985|NCT01675726|"     AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very     preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL     reported by a French general population of reference. 3) to determine whether     socio-demographic factors, neonatal features and neurocognitive status were impacting their     QoL.      METHODS:        -  Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier,          Nantes, Nîmes, Nice and Rouen).        -  Inclusion criteria: all infants born before 28 weeks of gestation between January 2005          and December 2007, from 7 to 9 years old of age at the time of evaluation.        -  Written agreement to participate: collected from parents.        -  Data collection: reports of children's QoL by children and their parents (using          standardized validated questionnaires); clinical information about the children,          obtained through a medical examination; children neurocognitive profile.        -  Duration of inclusion: over 24 months.        -  Population: of the six structures, approximately 300 children will be evaluated          consistent with the active files of the participating centres and an attrition rate of          30%.      PERSPECTIVES This is one of the first studies to collect self-reported data on quality of     life of school-age children (7-9 years) born before 28 weeks of gestation. A better     understanding of demographic and clinical determinants of QOL of school-age very preterm     children may help clinicians involved in the care of these children in their ethical and     medical considerations.   "
254986|NCT01667419|"     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the     efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF     mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two     separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA     (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in     diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer     (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC     cutaneous melanoma, as defined by this classification scheme. Within each cohort,     participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a     52-week period.   "
254994|NCT01597778|"     Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or     lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar     tissue type can be used for HCT. This study will compare the effectiveness of two new types     of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow     donated from family members with only partially matched bone marrow; and, one that uses two     partially matched cord blood units.   "
254996|NCT01585675|"     The primary objective of the protocol is to develop a comprehensive specimen banking program     from patients with lung cancer for future translation research, which will enable the     investigators to detect lung cancer earlier, develop better therapies and explore screening     and prevention strategies.   "
254999|NCT01544088|"     The purpose of this study is to examine whether group cognitive behavioral treatment (GCBT)     is efficacious in the treatment of PTSD in a sample of male Veterans. Veterans with a primary     diagnosis of chronic PTSD will be randomly assigned to either GCBT or a supportive group     treatment condition. Both treatments will consist of 14, weekly sessions. Assessment of PTSD     and related symptoms will be conducted at pre-treatment, mid treatment, post-treatment, and     3-, 6-, - and 12-month follow-up.   "
255008|NCT01460810|"     A prospective, experimental, case series of 20 patients, with choroidal melanoma, in which     pars plana vitrectomy and Silicone oil as vitreous substitute will be used as intraocular     shielding for attenuating the deleterious effects of radiation dose delivered to healthy     ocular tissue during Iodine-125 plaque brachytherapy treatment and assess if the treatment     can reduce the incidence and severity of radiation-induced adverse effects like radiation     retinopathy and permanent loss of vision.   "
255012|NCT01410344|"     The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT     for patients with chemotherapy-sensitive hematological malignancies and coincident     HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an     indicator of the safety of transplant in this patient population. Correlative assays will     focus upon the incidence of infectious complications in this patient population, the     evolution of HIV infection and immunological reconstitution. Where feasible (and when this     can be accomplished without compromise of either the donor quality or the timeliness of     transplantation), an attempt will be made to identify donors who are homozygotes for the     delta32 mutation for CCR5.   "
255015|NCT01400607|"     ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the     safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4     articular cartilage lesions of the knee compared to microfracture treatment.   "
255017|NCT01367665|"     This single-arm, open-label, multi-center study will evaluate the safety and efficacy of     vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma.     Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or     unacceptable toxicity.   "
255019|NCT01343043|"     The purpose of this early (pilot) clinical trial is to test the effects (both good and bad)     of chemotherapy and adoptive immunotherapy with T cells engineered to recognize NY-ESO-1     peptide in patients with unresectable, metastatic or recurrent synovial sarcoma.   "
255021|NCT01304940|"     The purpose of this study is to examine the relationship between trauma and startle. The     investigators are also looking at the effect of menstrual phase on this relationship.   "
255022|NCT01277263|"     Women with Breast Cancer who do not respond to chemotherapy may undergo months of treatment     with little or no change in tumor size or overall outcome.      The Researchers have demonstrated a previously undescribed metabolic flare response     observed very early in neoadjuvant treatment in breast cancer patients. The research can     determine that this flare is predictive of overall therapy response and is due to both an     inflammatory reaction and cell death induced by cytotoxic therapy.   "
255026|NCT01262560|"     RATIONALE: Manuka honey may prevent or reduce esophagitis-related pain caused by chemotherapy     and radiation therapy. It is not yet known whether Manuka honey is more effective than     standard care in preventing pain.      PURPOSE: This randomized phase II clinical trial is studying Manuka honey to see how well it     works in preventing esophagitis-related pain in patients receiving chemotherapy and radiation     therapy for lung cancer.   "
255034|NCT02171377|"     Quadricipital electrical stimulation added to respiratory rehabilitation in COPD patients.      Quadricipital electrical stimulation (ES) in chronic obstructive pulmonary disease (COPD)     patients has been demonstrated to improve both dyspnea and physical status. The aim of our     study is to demonstrate that ES added to respiratory rehabilitation program induces a greater     improvement on exercise tolerance in such patients.      Design : 160 patients with severe COPD will be randomly assigned to 2 groups : either     rehabilitation program (group 1), either ES and rehabilitation program (group 2). In both     groups, rehabilitation program comprises endurance training, 18 - 24 sessions (6 - 8 weeks),     health education, global muscular strengthening. In group 2, bilateral quadricipital     electrical stimulation 30 min sessions is added 5 days / week.      Subjects : COPD patients with FEV1 < 60% pred, FEV1/VC < 70%, and TLC > 80%, with dyspnea, in     stable conditions, and 18 > BMI < 35 kg/m² .      Intervention : 6 min walking distance, incremental exercise test data (aerobic capacity, work     rate, ventilatory threshold), physical activity with activity monitor, health related quality     of life will be determined before and after training.      Abbreviations : FEV1 = forced expiratory volume in 1 sec; VC = vital capacity; TLC = total     lung capacity; BMI = body mass index.   "
255035|NCT01205776|"     To establish the safety and efficacy of the commercially approved XIENCE Family Stent System     (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the     United States [OUS] only]) in subjects with unprotected left main coronary artery disease by     comparing to coronary artery bypass graft surgery.   "
255042|NCT01116414|"     The purpose of this study is to develop an integrated view of molecular mechanisms underlying     CF lung disease severity.   "
255055|NCT00945152|"     Based on personal experience and the literature it is reasonable expectation that Vancomycin     is a viable treatment in a direct contact form to eliminate MRSA from open wounds in order to     heal the wounds by conventional means. The key question in my research has been to measure     the effectiveness of my Vancomycin Gel by culturing the wound, applying the Gel in a     controlled manner and then culturing the wound after one week. The end point to achieve in     the process, is a clinical response of accelerated healing and negative culture report.     Another question to solve is the duration of potency and stability of the Vancomycin gel over     time.   "
255043|NCT01132482|"     Dehydrated airway surfaces resulting from sodium hyperabsorption and lack of chloride     secretion are critical to the pathology that leads to the morbidity and mortality from Cystic     Fibrosis (CF) lung disease. Previously published work in CF cell lines has demonstrated that     by increasing cGMP and restoring inhibition of ENaC, sodium hyperabsorption may be reversed     following administration of a phosphodiesterase inhibitor (PDEi,) such as sildenafil.     Additionally it has been shown in CF cell lines and animal models, that phosphodiesterase     inhibitors/analogues can enhance chloride secretion and/or correct surface localization of     ΔF508 CFTR. The goal of this project is to translate the results of this work from the     laboratory into a clinical trial in patients with CF using an FDA-approved therapy. The     Specific Aims of this project are to: 1) Evaluate the effect of systemically administered     phosphodiesterase inhibitors on ion transport in CF by measurement of Na+ and Cl- conductance     by NPD and Na+ and Cl- concentration in sweat utilizing pilocarpine iontophoresis 2) To     establish appropriate dosing of sildenafil in CF by performing a dose-escalation study during     which patients are carefully monitored for side effects, plasma sildenafil levels are     obtained and outcome measures are compared based on the dose of sildenafil administered. The     results of this study in conjunction with those from an ongoing study examining the role of     sildenafil as an anti-inflammatory in CF will aid in establishing safety, pharmacokinetics     and mechanism of action of sildenafil in the treatment of CF lung disease.   "
255044|NCT01104220|"     The purpose of this study is to learn more about how the body stores fat in and around organs     (ex. the liver) and why this affects some people's health more than others. Understanding     this may lead to better treatments for diseases such as diabetes and cardiovascular disease.   "
255045|NCT01112306|"     Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the     safety and tolerability of ACT-293987 in patients with PAH who participated in the     double-blind study AC-065A302 (GRIPHON)   "
255046|NCT01085864|"     A need exists for non-invasive testing to aid in clinical decision-making for Computerized     Tomography (CT) scan detected lung nodules of indeterminate etiology. The investigators     hypothesize that biomarkers detectable in blood, sputum or urine may be useful for guiding     clinical decisions in the setting of CT detected lung nodules to determine which nodules are     malignant and which are benign. The investigators also hypothesize that these biomarkers will     decrease in concentration to the normal range after successful surgical treatment of     malignant lung nodules.   "
255047|NCT01071824|"     The aim of the study is the comparison of pouch function with two different sizes of limb of     transverse coloplasty pouch after rectal resection and total mesorectal excision.   "
255049|NCT01014286|"     The primary objective of this protocol is to determine the frequency of oncogenic mutations     in 1000 patients with advanced adenocarcinoma of the lung. The linked clinical and mutational     analyses will be used to determine the frequency of each mutation, its association with     clinical features and outcome, and its association with other mutations. As future     therapeutic protocols specific for these mutations are developed, patients may be notified of     their eligibility for these studies. Future translational studies may be used to: a) unravel     the complex biology of lung cancer; b) identify prognostic markers; c) define predictive     markers of response/resistance to new therapies; d) identify new targets. A secondary goal is     to establish a consortium of sites that have the capability of conducting multiple mutation     testing in a Clinical Laboratory Improvement Amendments (CLIA) certified lab.   "
255051|NCT01005407|"     The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency     of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years     of age   "
255087|NCT00332124|"     This study will evaluate the safety and effectiveness of taking choline supplements during     pregnancy, and whether choline supplementation has an effect on infant development.   "
255528|NCT03038646|"     -  To evaluate the pharmacokinetic (PK) profiles of MIN-l0l following administration of          modified release (MR) formulations of MIN-l0l in healthy male and female subjects        -  To select 1 MR formulation for use in fed state        -  To evaluate the effect of food on the bioavailability of MIN-l0l selected MR formulation   "
255064|NCT00804583|"     This study examines modifier genes that may play a role in the development of CF liver     disease. Modifier genes are genes, other than the CF gene (CFTR), which may directly or     indirectly have an affect on how the body responds to the conditions that develop as the     result of the defective CFTR gene. Scientists have wondered why some patients with CF develop     CF liver disease and why some patients with CF do not. To better understand the problem, this     study was designed to examine the genetic makeup of CF patients who are considered to have     severe liver disease to see if they can identify any modifier genes. Researchers will study     blood samples, pulmonary function tests, and other medical information in hopes that a     connection can be made between genetic make-up and how severe the liver disease is. The     identification of modifier genes that influence disease severity may ultimately lead to a     better understanding of CF liver disease, and may be useful in the development of new     treatments.   "
255068|NCT00697632|"     In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients     with advanced malignancies to study its safety profile.   "
255071|NCT00656955|"     Background:      In Central Europe, mortality rates for kidney cancers are higher and survival rates are lower     than in the United States and Western Europe overall.      The Central and Eastern European Renal Cancer Case-Control Study (CEERCC), completed in 2002,     offers an opportunity to identify determinants that predict 5-year survival among kidney     cancer patients.      Objectives:      To assess disease recurrence and progression among former participants in the CEERCC.      To investigate the effect of genetics, lifestyle factors, medical conditions, occupation and     diet on the outcome of kidney cancer patients in Europe.      Eligibility:      Former participants or next-of-kin of former participants in the CEERCC study.      Design:      Participants or their next-of-kin are interviewed for 60 minutes and are requested permission     to collect relevant information from their or their family member s hospital and cancer     registry records.   "
255072|NCT00670631|"     The two objectives of this study are:        -  To increase the 2-year event-free survival from 55%, established with Total Therapy II          (UARK 98-026), to 75% in myeloma patients with cytogenetic abnormalities, and from 80%,          established with the Total Therapy II regimen, to 95% in myeloma patients without          cytogenetic abnormalities.        -  To determine whether bortezomib, thalidomide, and dexamethasone can be safely          incorporated with transplant 1 into the established pre-transplant regimen of high-dose          melphalan (used in Total Therapy II) and whether Velcade and gemcitabine can be safely          added to the transplant 2 high-dose chemotherapy regimen of combination melphalan and          BCNU.   "
255075|NCT00578643|"     This study is for patients with chronic granulomatous disease (CGD), which is a disorder of     the immune system that puts them at risk for severe infections. CGD is caused by a genetic     defect that stops or prevents the white blood cells from killing certain bacteria and fungi.     This condition cannot presently be cured by standard treatment with drugs or surgery. The     course over time of CGD may differ in severity among patients, but those children who develop     severe infection at a young age are most likely to have a more severe clinical course.     Medicine including antibiotics, antifungals, and interferon gamma, may help some patients     with CGD; however even with continuous treatment with these medications, most patients with     CGD will have chronic and recurrent infections. Transfusion of healthy or normal white blood     cells may help overcome infection, but white cell transfusions lead to allergic reactions and     fever and the benefit of transfusion lasts only a matter of hours. Ultimately, chronic     infections can damage or injure the body organs such as the lung, liver, or bone. Injury to     the lung or liver can lead to lung or liver failure and death. Medicines used to treat     infection can damage body organs such as the kidney. Infections may become resistant to     antibiotic or antifungal treatment, and infections not responding to treatment can be deadly.      It is now known that under specific conditions and with special treatment, blood stem cells     (the cells that make blood) can be transferred or transplanted from one person to another.     Stem cell transplantation has been done for patients with CGD who have a healthy brother or     sister and who share the same immune type (HLA type) as the patient. Stem cell     transplantation allows healthy or normal white cells from the stem cell donor to grow or     develop in the patient's bone marrow making the donor's white cells. These healthy white     cells can fight infection and prevent future infections for a patient with CGD.      Patients on this study will receive stem cells from a related or an unrelated donor. The     donor will be closely matched to the patients immune type but the donor is not a brother or     sister. This type of transplantation has been done only a few times for patients with CGD,     although this type of transplant is commonly done for other reasons, e.g. leukemia. The     reason this treatment is investigational is that we do not know the likelihood of benefit     that the patient will receive. It is possible that they will have great benefit, like some of     the patients who have been transplanted from a brother or sister. It is possible that the     side-effects of treatment may be too severe so that the transplant won't work.      The purpose of this research study is to evaluate whether or not patients with CGD treated     with a stem cell transplant from a non-matched and/or non-related donor can have a good     outcome from the procedure with an acceptable number of side-effects.   "
255077|NCT00573014|"     The optimal method of clearing the cervical spine in obtunded trauma patients is unclear.     Computed tomography (CT) identifies most injuries but may miss ligamentous injuries. Magnetic     resonance (MR) imaging has been widely used to exclude ligamentous injuries. We postulate     that with the new generation of CT scanners, MR imaging is not needed to rule out significant     injuries. Our protocol for clearing the cervical spine in obtunded trauma patients depends on     CT alone. We are prospectively following these patients and performing a clinical examination     when they are awake to show this is a safe approach.   "
255078|NCT00565851|"     This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride     when given together with or without bevacizumab after surgery to see how well it works in     treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that     has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine     hydrochloride work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal     antibodies, such as bevacizumab, may block tumor growth in different ways by targeting     certain cells. It is not yet known whether combination chemotherapy is more effective when     given with or without bevacizumab after surgery in treating patients with ovarian,     epithelial, primary peritoneal, or fallopian tube cancer.   "
255079|NCT00435812|"     The purpose of this study is to find out if a new investigational hepatitis B virus vaccine,     HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years     old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at     least as good as that of Engerix-B®.   "
255097|NCT00101998|"     A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of     an investigational drug for the treatment of constipation due to prescription pain medication     in subjects with cancer pain. The study will require five visits over a five-week period.   "
255093|NCT00241722|"     Adults who are taking opioid therapy for persistent non-cancer pain and have resulting     opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The     primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo     for safety and tolerability in the treatment of OBD. Participants will be required to attend     8 clinic visits over approximately 1 year.   "
255081|NCT00392327|"     This randomized phase III trial studies different chemotherapy and radiation therapy regimens     to compare how well they work in treating young patients with newly diagnosed, previously     untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine     sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. Isotretinoin may help chemotherapy work better by making tumor cells more     sensitive to the drugs. Radiation therapy uses high-energy x-rays to kill tumor cells.     Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known     which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.   "
255082|NCT00378482|"     This study is intended to provide access to CP-675,206 for patients who have previously     received CP-675,206 in a clinical trial.   "
255083|NCT00368082|"     Patients have a type of lymph gland cancer called HD, NHL or lymphoepithelioma (these 3     diseases will be referred to as Lymphoma). The lymphoma has come back or has not gone away     after treatment (including the best treatment known for these cancers). This is a research     study using special immune system cells called TGFb-resistant LMP-specific cytotoxic T     lymphocytes (DNR-CTL), a new experimental therapy.      Some patients with Lymphoma show signs of infection with the virus that causes infectious     mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis of the     Lymphoma. EBV is found in the cancer cells of up to 1/2 the patients with Lymphoma,     suggesting it may play a role in causing Lymphoma. The cancer cells infected by EBV are able     to hide from the body's immune system and escape being killed by releasing a substance called     Transforming Growth Factor-beta (TGFb). The investigators want to see if special white blood     cells (called T cells) that have been given a gene that they hope will let them survive     against TGFb and that have been trained to kill EBV infected cells can also survive in the     blood and kill the tumor.      Investigators have used this sort of therapy with specially trained T cells to treat a     different type of cancer that occurs after bone marrow and solid organ transplant called post     transplant lymphoma. In this type of cancer they were able to successfully prevent and treat     post transplant lymphoma. However when they used a similar approach in HD some patients had a     partial response to this therapy, but no patients had a complete response. In a follow-up     study they tried to find out if they could improve this treatment by growing T cells that     recognize 2 of the proteins expressed on Lymphoma cells called LMP-1 and LMP2a. These special     T cells were called LMP-specific cytotoxic T-lymphocytes (CTLs). Although some patients had     tumor responses, CTL therapy alone did not cure those who had a lot of disease. Investigators     think that a reason for this is that the tumor cells are releasing TGFb (a substance that     inhibits the growth and function of CTLs). For this reason, they want to find out if they can     make the CTL resistant to TGFb by putting in a new gene called TGFb resistance gene.     Investigators hope but don't know that this will improve this treatment for relapsed     lymphoma. These TGFb-resistant LMP-specific CTLs are an investigational product not approved     by FDA.      The purpose of this study is to find the largest safe dose of TGFb resistant LMP-specific     CTLs, to learn what the side effects are and to see whether this therapy might help patients     with HD, NHL and lymphoepithelioma.   "
255084|NCT00351390|"     Levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP) a hormone released from     the heart in patients with heart failure (HF) are strongly prognostic of adverse events, such     as hospitalization or death from HF. Therapies that are beneficial for HF (such as beta     blockers or angiotensin converting enzyme inhibitors) tend to lower levels of NT-proBNP in     parallel with improvements in outcomes of patients so treated. Importantly, Nt-proBNP levels     may identify a patient at high risk for adverse outcome from their HF, even in periods of     apparent stability.      It remains unclear, however, whether treating patients based on their NT-proBNP     concentrations would be associated with better outcomes compared to standard HF therapy     without measurement of NT-proBNP values.      The goal of the PROTECT study is to evaluate whether treatment of patients with advanced and     recently destabilized HF would benefit from NT-proBNP guided HF treatment, compared to     standard HF therapy without such 'hormone guided' treatment.   "
255085|NCT00340899|"     Preterm delivery, preeclampsia and intrauterine growth restriction are leading causes of     perinatal morbidity and mortality. Efforts to treat these syndromes have not been effective,     most likely becuase these obstetric complications are the clinical expression of adaptive     mechanisms of host defense developed in response to pathologic insults. Since the ultimate     pathologic basis of disease is unclear, therapy for these syndromes has been largely directed     at symptoms, which appear late in the development of the disease. The main purpose of this     study is to perform an early and comprehensive exploration of maternal and fetal factors that     predict the subsequent develpment of these obstetrice complications, so that early medical     interventions may be tested in patients at high and low risk for adverse perinatal outcome.   "
255088|NCT00331162|"     The purpose of this research study is to compare the effects of the two most commonly used     anti-T cell induction agents(alemtuzumab and rabbit anti-thymocyte globulin) to prevent     rejection in kidney and pancreas transplant patients. Alemtuzumab is Food and Drug     Administration (FDA) approved for treating a certain type of cancer (leukemia), and     Thymoglobulin® (rabbit anti-thymocyte globulin) is approved for anti-rejection treatment, but     neither drug is FDA approved for administration at the time of transplantation to help     prevent rejection. Even so, many transplant centers use these medications at the time of     transplantation and believe that their use helps to decrease the risk of developing rejection     following kidney and pancreas transplantation. Which drug might be better is not known.     Subjects will receive either alemtuzumab (one administration) or rabbit anti-thymocyte (3 to     7 doses) at and within the first week of transplantation. Subjects will be assigned to either     the alemtuzumab or rabbit anti-thymocyte globulin groups by chance. The two groups will be     compared to see if there are meaningful differences for survival, organ function, side     effects, and quality of life. The follow-up care after transplant for subjects in the study     is the same as that for patients who are not in the study, except that a quality of life     questionnaire (estimated to take 10 minutes to complete) will be completed at the time of     transplant and through year 2 during selected scheduled clinic visits. A retrospective chart     review will occur at 3-5 years post-transplant to follow incidence of chronic rejection,     patient and graft survival and graft function.   "
255091|NCT00296140|"     Post Stroke Depression(PSD)is a high volume condition with negative impact on patient     recovery after stroke. The primary aim of this study is to evaluate the effectiveness of a     system intervention to improve the proportion of veterans screened and started on treatment     for PSD.      The secondary aim is evaluate whether a patient-based self-management intervention provides     any additional benefit compared to usual care.   "
255092|NCT00281684|"     This clinical trial is a multi centre, randomised, single-blind, parallel group,     placebo-controlled, single oral dose study with a positive control arm. Patients previously     scheduled for 3rd molar tooth extraction, who are otherwise healthy, will be recruited. Upon     completion of surgery, e.g. prior to established pain, patients will be randomised to     treatment (SB-706598, placebo or co-codamol) and dosed with the study medication   "
255094|NCT00368355|"     Subjects are being asked to participate in this study because treatment of their disease     requires them to receive a stem cell transplant. Stem cells or mother cells are the source     of normal blood cells and lead to recovery of blood counts after bone marrow transplantation.     Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother)     and the subject's disease is considered rapidly progressive and does not permit enough time     to identify another donor (like someone from a registry list that is not their relative). We     have, however, identified a close relative of the subject's whose stem cells are not a     perfect match, but can be used. However, with this type of donor, there is typically an     increased risk of developing graft-versus-host disease (GVHD), a high rate of transplant     failure, and a longer delay in the recovery of the immune system.      GVHD is a serious and sometimes fatal side effect of stem cell transplant. GVHD occurs when     the new donor cells (graft) recognizes that the body tissues of the patient (host) are     different from those of the donor. When this happens, cells in the graft may attack the host     organs, primarily the skin, liver, and intestines. The number of occurrences and harshness of     severe GVHD depends on several factors, including the degree of genetic differences between     the donor and recipient, the intensity of the pre-treatment conditioning regimen, the     quantity of transplanted cells, and the recipient's age. In recipients of mismatched family     member or matched unrelated donor stem cell transplants, there is a greater risk of GVHD so     that 70-90% of recipients of unchanged marrow will develop severe GVHD which could include     symptoms such as marked diarrhea, liver failure, or even death.      In an effort to lower the occurrences and severity of graft-versus-host disease in patients     and to lower the rate of transplant failure, we would like to specially treat the donor's     blood cells to remove cells that are most likely to attack the patient's tissues. This will     occur in combination with intense conditioning treatment that the patient will receive before     the transplant.   "
255095|NCT00216710|"     This study will assess the effectiveness of early home visitation by a professional in     preventing child maltreatment, promoting healthy family functioning, and promoting child     health and development.      The investigators will test the following hypotheses regarding the effectiveness of early     paraprofessional home visiting for at-risk families        -  Actual home visiting services adhere to HFAK standards.        -  HFAK promotes healthy family functioning, promotes child health and development, and          prevents child abuse and neglect.        -  Adherence to HFAK process standards is positively associated with achievement of          outcomes.   "
255096|NCT00217308|"     Purpose of the study is to determine the effect of probiotic lactobacilli on the vaginal     flora and cytokine profile during pregnancy, and the incidence of preterm labour in women at     high risk for preterm birth.   "
255099|NCT00062868|"     Patients have a type of lymph gland disease (HD or NHL, Lymphoepithelioma, severe chronic     active EBV (SCAEBV), or leiomyosarcoma) which has come back or may come back or has not gone     away after treatment, including the best treatment known for these diseases. This research     study uses special immune system cells called LMP- specific cytotoxic T lymphocytes, a new     experimental therapy.      Some patients with Lymphoma or SCAEBV or leiomyosarcoma show evidence of infection with the     virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of     their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's     and NHL, suggesting that it may play a role in causing Lymphoma. The cancer cells (in     lymphoma) and some B cells (in SCAEBV) infected by EBV are able to hide from the body's     immune system and escape destruction. Investigators want to see if special white blood cells,     called T cells, that have been trained to kill EBV infected cells can survive in the blood     and affect the tumor.      The Investigators have used this sort of therapy to treat a different type of cancer that     occurs after bone marrow or solid organ transplant called post transplant lymphoma. In this     type of cancer the tumor cells have 9 proteins made by EBV on their surface. The     investigators grew T cells in the lab that recognized all 9 proteins and were able to     successfully prevent and treat post transplant lymphoma. However, in HD and NHL and SCAEBV,     the tumor cells and B cells only express 2 EBV proteins. In a previous study, T cells were     made that recognized all 9 proteins and were given to patients with HD. Some patients had a     partial response to this therapy but no patients had a complete response. The investigators     think one reason may be that many of the T cells reacted with proteins that were not on the     tumor cells. In this study, they are trying to find out if they can improve this treatment by     growing T cells that recognize proteins expressed on EBV infected Lymphoma cells and B cells     called LMP-1 and LMP2. These special T cells are called LMP-specific cytotoxic T-lymphocytes     (CTLs). These LMP-specific cytotoxic T cells are an investigational product not approved by     the FDA.      The purpose of this study is to find the largest safe dose of LMP-specific cytotoxic T cells,     to learn what the side effects are and to see whether this therapy might help patients with     HD, NHL, Lymphoepithelioma, SCAEBV or leiomyosarcoma.   "
255105|NCT00001846|"     This protocol is designed to provide a mechanism for the Department of Transfusion Medicine,     Clinical Center to collect and process blood components from paid, healthy volunteer donors     for distribution to NIH intramural investigators and FDA researchers for in vitro laboratory     use. Donors meeting research donor eligibility criteria will be recruited to donate blood and     blood components by standard phlebotomy and apheresis techniques. The investigational nature     of the studies in which their blood will be used, and the risks and discomforts of the     donation process will be carefully explained to the donors, and a signed informed consent     document will be obtained. Donors will be compensated according to an established schedule     based on the duration and discomfort of the donation. NIH and FDA investigators requesting     blood components for research use will be required to submit an electronic (Web-based) memo     of request, briefly describing the nature of the research, and providing assurance that     samples provided through this protocol will be used solely for in vitro and not for in vivo     research. This protocol also provides a detailed schema for careful and frequent laboratory     safety monitoring of repeat research apheresis donors.      Blood components for research use will be distributed with a unique product number, and the     DTM principal and associate investigators will serve as the custodians of the code that links     the product with a donor s identity. The nature of the in vitro studies in which the blood     and components collected in this study will be used is not the subject of this protocol, and     is not possible to describe, since it involves basic investigative efforts in greater than     170 different NIH and FDA laboratories. The intent of this protocol is not to approve the     research itself, but to provide adequate and complete informed consent for the donor, and to     assure that the education, counseling, and protection of the study subjects (research blood     donors) is performed in accordance with IRB, OHSR, OPRR and other applicable Federal     regulatory standards   "
255106|NCT00001208|"     Botulism is a severe form of food poisoning caused by bacteria. This bacteria produces     several toxins one of which is botulinum toxin A. This toxin causes the symptoms of food     poisoning. Small amounts of botulinum toxin A have been used to treat speech disorders such     as stuttering and problems with the muscles of the eyes.      The study examines the effectiveness of botulinum toxin as treatment for a variety of     movement disorders. The goals of the study are to refine the technique of treatment to     provide the best results, to improve the understanding of how botulinum toxin works on     movement disorders, and find other conditions that may be treatable with botulinum toxin.      In addition, researchers also plan to study the possible use of botulinum toxin F alone and     in combination with botulinum toxin A in patients who do not respond to botulinum A toxin     treatment.<TAB>   "
255142|NCT03269747|"     Interventional, Placebo controlled cross-over study to investigate the short-term effects of     glucocorticoids (prednisone) on human brown adipose tissue.   "
255126|NCT03269149|"     The goal of the project is to determine the extent to which indices of inflammatory     biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs     control condition in African American (AA) female family caregivers, at high risk for     Alzheimer's disease (AD).   "
255127|NCT03268772|"     This study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin     (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced     or metastatic soft tissue sarcoma (STS).   "
255177|NCT03270124|"     This study is being performed in patients who have undergone transcatheter aortic valve     replacement (TAVR) for aortic stenosis. The goal is to obtain pilot and feasibility data on a     novel post-procedure rehabilitation strategy, including a daily activity goal using a     waist-worn accelerometer and in-home resistance training exercises targeting muscles related     to activities of daily living. We will evaluate the effect of these interventions on physical     performance and several quality of life domains.   "
255128|NCT03268603|"     The purpose of this study is to determine the safety and efficacy of intrathecal treatment     delivered to the cerebrospinal fluid (CSF) of mesenchymal stem cells in ALS patients every 3     months for a total of 4 injections over 12 months.      Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown into a number of     different kinds of cells. In this study, MSCs will be taken from the subject's body fat and     grown. CSF is the fluid surrounding the spine.      The use of mesenchymal stem cells is considered investigational, which means it has not been     approved by the Food and Drug Administration (FDA) for routine clinical use. However, the FDA     has allowed the use of mesenchymal stem cells in this research study.   "
255130|NCT03268577|"     This research trial studies how well internet-based and self-report instruments measure food     intake and physical activity levels and their relationship with disease within American     Association of Retired Persons (AARP) members. Comparing new internet-based questionnaires     developed by the National Cancer Institute that report all the foods consumed and activities     performed in an entire day to standardized physical measurements may help to determine if the     information collected is accurate.   "
255131|NCT03270202|"     This study evaluates the effect of a new wearable device, that measures physical activity     level based on heart rates, on relevant health outcomes including cardiorespiratory fitness.     Half of participants will be instructed in using the Mio Slice wristband, while the other     half will be requested to follow today`s recommendations for physical activity.   "
255133|NCT03268889|"     This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL     patients.   "
255134|NCT03268941|"     The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants     with Gastroparesis (GP).   "
255135|NCT03268954|"     The purpose of this study is to determine whether the combination of pevonedistat and     azacitidine improves overall response rate (ORR) by Cycle 6 and whether the combination of     pevonedistat and azacitidine improves event-free survival (EFS) when compared with     single-agent azacitidine.   "
255136|NCT03269019|"     Heparin induced thrombocytopenia (HIT) is a kind of catastrophic thrombotic complications     after the application of heparin. If HIT without treatment, death rate is as high as 30% to     50%. Early diagnosis of HIT and prevention of thrombosis is very important.      This study is planned to assess the use of thrombotic biomarkers in patients with HIT,     including thrombin-antithrombin complex, d-dimer, fibrin degradation products and     Thrombelastograghy monitoring . These biomarkers are monitored in 5-14 days post-operation to     assess the risk of thrombosis in HIT patients. All patients were followed up for 30 days, and     clinical outcomes, including new thrombus and death, were recorded during follow-up.   "
255137|NCT03269032|"     This study will evaluate the impact of a Mediterranean-style diet on microbiome diversity     compared to a typical American diet. The study will observe the microbiome composition     comparisons in healthy volunteers as well as in patients with Irritable Bowel Syndrome with     Diarrhea (IBS-D) to see if the consumption of a Mediterranean-style diet has a positive     effect on improving symptoms of IBS-D.   "
255140|NCT03269084|"     The Type 1 Diabetes Prediction and Prevention (DIPP) Study in Finland is a population-based     long-term clinical follow-up study established since 1994 in three university hospitals in     Finland to understand the pathogenesis of type 1 diabetes (T1D), predict the disease, and     find preventive treatment.   "
255141|NCT03269721|"     COPD is the third leading cause of combined morbidity, disability, and mortality in the     United States and is often associated with cognitive impairment. The goal of the proposed     project is to examine novel pulmonary and vascular physiological mechanisms that contribute     to structural brain abnormalities and cognitive dysfunction early in the course of COPD. The     project will generate information to ultimately inform the development of interventions to     delay or prevent cognitive dysfunction.   "
255145|NCT03269760|"     The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of     orthopaedic shoulder arthroplasty patients. We hypothesize that a multimodal sleep pathway     including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve     patient sleep, pain control, and subsequent recovery after undergoing total shoulder     arthroplasty.   "
255146|NCT03269695|"     The purpose of this study is to determine if PF-06687234 is effective and safe as add-on     therapy to infliximab in subjects with active ulcerative colitis who are not in remission.   "
255150|NCT03269656|"     5764 men and women in Iceland, aged 66 to 96 years entered the Ages Gene/Environment     Susceptibility (AGES) - Reykjavik Study. Serum 25(OH)D was measured in 5,519 of all 5,764     (96%) participants at study entry in year 2002 through 2006. The main emphasis was on     exploring whether pre-diagnostic serum levels of 25(OH)D were associated with survival after     cancer diagnosis.   "
255154|NCT03270553|"     This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover     study to evaluate the drug-drug interaction potential between plazomicin and metformin in     healthy subjects.   "
255155|NCT03269968|"     Obese women are more likely have a cesarean delivery and develop subsequent wound     complications than normal weight women. Negative pressure wound therapy (NPWT) has been shown     to improve surgical wound healing, but this device has not been adequately studied in     cesarean deliveries. The aim of our study is to determine the efficacy of NPWT in morbidly     obese women after cesarean delivery.      We will be randomizing women with a BMI > 40 kg/m2 in a 1:1 ratio to either NPWT (the PREVENA     Incision management therapy system Pre 1001 Us) or standard dressing after their cesarean     delivery at MedStar Washington Hospital Center. The NPWT will be left in place for a minimum     of four days but not to exceed seven days. The standard dressing is typically removed on     postoperative day one or two. Our primary outcome is a wound complication defined as the     formation of a wound infection, seroma, hematoma, separation, or dehiscence from delivery to     4 weeks postpartum. We will also administer a patient satisfaction survey regarding their     wound healing experience.   "
255156|NCT03269981|"     This study evaluates the impact of elective regional lymph node irradiation on N1 breast     cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane     (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph     nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either     whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone     (WBI group).   "
255160|NCT03270358|"     Our hypothesis is that a plasma protein named osteopontin (OPN) could serve as a biological     predictive marker of acute AVF dysfunction. In several scientific studies, plasma OPN was     correlated with coronary stent restenosis, and with cardiovascular outcome in patients with     diabetes and renal insufficiency. This protein is secreted by several cellular types, like     distal tubule epithelial cells, macrophages, but also fibroblasts and cardiac and vascular     endothelial cells, in response to several specific stimuli. It acts like a cytokine, inducing     immunological mechanisms as well as tissue remodeling.      The main objective of this study is to show that the amount of plasma OPN is higher in     patients presenting with an AVF stenosis, compared with patients with a functioning AVF.      OSMOSIS is a monocentric pilot study that will include patients into two groups during 12     months (no specific follow-up). The control group will include patients that have been     dialyzed on an AVF, in the dialysis center of Nice University Hospital, for at least 3 months     without any incident. The experimental group will include hemodialysis patients hospitalized     in the department of vascular surgery for acute AVF dysfunction, needing endovascular or open     surgical revision for venous stenosis.      Blood will be withdrawn right before dialysis or surgical procedure. Plasma OPN will me     measured by ELISA. Their clinical data would be collected from medical file at the same time.     After the procedure, patients will be followed-up according to usual protocols.      To show a significant difference of 100ng/mL plasma OPN between the two groups, with a power     of 90% and alpha risk of 0.05, we plan to include 76 patients   "
255161|NCT03269708|"     The purpose of this study is to determine whether providing individuals with personalized     information on cellular aging, including telomere dynamics, will stimulate them to adhere to     cardiac prevention strategies and improve exercise capacity.   "
255162|NCT03270332|"     The purpose of the present pilot study is to test the hypothesis that in patients with group     1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator     therapy, inhaled albuterol causes transient pulmonary vasodilation. If the results support     this premise, they could serve as the basis for a phase 2 trial investigating the potential     for using inhaled long-acting β2-adrenergic agonists as add-on therapy in group 1 PAH.     Echocardiography will be performed before and after administration of inhaled albuterol.   "
255163|NCT03269734|"     This study compares the accuracy of fusion imaging (Fusion Roadmap) versus real-time X-ray     imaging (Roadmap) during catheterization of supra-aortic trunks of in patients with aneurysms     or arteriovenous malformations.   "
255164|NCT03270059|"     This randomized phase II trial studies how well gadolinium and ferumoxytol magnetic resonance     imaging (MRI) works in diagnosing patients with abnormalities in the central nervous system.     Diagnostic procedures, such as gadolinium and ferumoxytol MRI, may help find and diagnose     abnormalities in the central nervous system.   "
255165|NCT03270111|"     The purpose of this second pilot study is to extend the feasibility demonstrated in     NCT02963740 that the intervention achieves high levels of moderate to vigorous physical     activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease     in older, obese sedentary breast cancer survivors who are undergoing moderate calorie     restriction.   "
255171|NCT03270098|"     People with schizophrenia display a broad range of cognitive impairments that have been     identified as major determinants of poor functioning and disability. The goal of the proposed     study is to examine the impact of exercise training on cognition, daily functioning, and     biomarkers of cognitive change in people with schizophrenia.   "
255220|NCT03270891|"     This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department     of family medicine (DFM) clinics at the University of Michigan (UM). Physicians practicing at     a UM DFM clinical site who are willing to utilize pharmacogenomic (PGx) test results for the     management of depression will be enrolled. Patients of these DFM physicians who are adults     with a new diagnosis of depression and have a current prescription for an antidepressant will     also be enrolled.   "
255172|NCT03268486|"     Cardiotocography (CTG) is widely used during labour wards in industrialised countries and     consists of fetal heart rate and uterine contraction monitoring. The main aim is to identify     fetuses that are being poorly oxygenated during labour and require medical intervention to     revert the situation or expedite delivery.      The need for technical development of CTG is well-recognized, as some of the existing     techniques are prone to signal loss and contamination from the maternal heart rate, while     others are invasive and have established contra-indications. They also limit maternal     mobilisation, contributing to maternal dissatisfaction, and possibly to adverse maternal and     neonatal outcomes.      New techniques for CTG acquisition will shortly be made available by a leading technological     company, providing non-invasive monitoring and allowing full maternal mobilisation, and with     the potential to change the way labour is conducted in high-resource countries. There is a     need for a systematic evaluation of their clinical performance and benefit.   "
255175|NCT03268187|"     The presented study compares the effectiveness of a biofeedback-based relaxation training     with the effectiveness of a biofeedback-based self-alert training on the reduction of fatigue     in multiple sclerosis patients using a between groups design. Furthermore, the relation of     fatigue in multiple sclerosis patients and autonomic potentials as well as the performance in     a vigilance task will be examined.      The relaxation training is based on the principle of progressive muscle relaxation according     to Jacobsen. The patient is asked to tense all muscles in their face and perceive consciously     the relaxation afterwards according to verbal cues. In the self-alert training condition, the     patient will hear verbal cues to increase their attention. In both conditions the external     cues given will be reduced in four phases until the patient has to cue himself. The patient     is advised to track the changes in the skin resistance mirrored by biofeedback on a screen.      In both conditions the training will be split on two days. During the whole examination heart     rate and skin resistance will be recorded. The allocation to the training happens randomly.     On the first day the patient will complete questionnaires to survey depression and apathy and     do a baseline vigilance task. Before and after the vigilance task the current fatigue status     will be assessed using a visual analogue scale. Afterwards an introduction in the treatment     method will be given.      On the second day the introduction into the training will be repeated. Afterwards a short     time vigilance task will be done and questionnaires to survey fatigue and sleep behaviour and     quality will be completed. Subsequently the last part of the training (no external cues) will     be done. The examination will be completed by a long-time vigilance task. Before and after     the vigilance task the current fatigue status will be assessed using a visual analogue scale.      It is hypothesised that especially the biofeedback-based self-alert training has a positive     effect on fatigue and the vigilance performance in multiple sclerosis patients, as it     increases the ectodermal activity and increases the sympathetic activation. It was shown that     phasic changes of the skin resistance are correlated with an increase of neuronal activity in     the brain areas relevant for vigilance (Critchley et al., 2002; Nagai et al., 2004). The     relaxation training will reduce the sympatho-adrenergic excitation disposition and reduce the     level of activity. Consequently, we do not expect an alleviation of the perceived fatigue     according to our underlying model (Hanken et al., 2016). In addition, it is hypothesized     that, independent from the treatment, autonomic potentials correlate with fatigue.   "
255896|NCT02387489|"     The purpose of the study is to examine the comparative effectiveness of a computerized brief     intervention vs. an in-person brief intervention delivered by a nurse in reducing marijuana,     alcohol, and sex risk behaviors in adolescents receiving services in school-based health     centers.   "
255209|NCT03269864|"     Perforator vessels are those where the source artery is deep and the branch that carries     blood to the fasciocutaneous tissues passes through the overlying deep fascia.      Soft tissue defects in the lower extremity, especially distal third of leg, present a     challenge to reconstructive surgeons due to lack of reliable local flaps, conventional     reconstructive options include split skin grafting, local random fasciocutaneous flaps, cross     leg fasciocutaneous flap, pedicled muscular or musculocutaneous flaps or microvascular free     tissue transfer. All these procedures have their limitations and associated morbidity at     donor site   "
255180|NCT03268044|"     Surgery is performed at the weekend for risk to life or limb, when mandated by clinical     guidelines, or depending on resource availability. Weekend healthcare interventions have been     associated with increased mortality and adverse clinical outcomes in the majority of the     literature examining the weekend effect, but these findings are not consistent. Results from     recent observational studies argue against a true weekend effect. Higher rates of adverse     outcomes associated with hospital activity at weekends do not appear to be due to altered     medical staffing as commonly hypothesized, but are thought to be in part a result of data     artefact and confounding by severity or indication. For this study, we hypothesized that     patients who are admitted to hospital at the weekend and require surgery have an increased     risk of death compared with patients who are admitted and undergo surgery on weekdays. The     primary aim was to examine whether patients who underwent surgery and were admitted at the     weekend had an increased risk of 30 day all-cause mortality compared with patients who were     admitted and underwent surgery on weekdays; secondary aim was to examine whether the timing     of surgery (i.e., surgery on the same weekend or surgery on a subsequent weekday) for     patients admitted at the weekend is associated with increased risk of 30 day all-cause     mortality.   "
255181|NCT03268031|"     Glaucoma is currently the second leading cause of irreversible blindness in the world. Our     study intends to combine clinical data of glaucoma patients in Zhongshan Ophthalmic Center     with Artificial Intelligence techniques to create programs that can screen and diagnose     glaucoma.   "
255183|NCT03269422|"     The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated     radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate     risk prostrate cancer.   "
255184|NCT03270033|"     In this single-centre, double-blinded, randomized controlled superiority trial, 189     participants having outpatient, arthroscopic shoulder surgery will be randomized into 3 equal     sized groups. All participants will receive a standardized interscalene brachial plexus block     and 4mg of dexamethasone or 50mcg of dexmedetomidine or both intravenously just prior to     their surgery. The purpose of this study is to provide a head to head comparison of two types     intravenous adjuncts to ISB, corticosteroids and alpha 2 agonists, and determine if their     combination, or either one alone provides superior postoperative analgesia in arthroscopic     shoulder surgery patients, as well as possibly show a synergistic relationship between the     two adjuncts. The investigators hypothesize the combination of adjuncts will provide a longer     duration of analgesia compared to either single agent.   "
255185|NCT03270345|"     The objective of this study is to provide an up-to-date, global picture of the extent and     patterns of pressure injuries in ICUs. Point prevalence studies are only of value when     performed on a vast scale. To sample a representative cohort, we intend to recruit about 1200     ICUs with all continents covered and as many countries as possible within each continent.   "
255186|NCT03269409|"     This randomized clinical trial aims to determine if cells from a patient's own adipose tissue     is safe and capable of helping regenerate the femoral head in patients with osteonecrosis.     The standard of care is known as hip decompression which simply removes dead tissue from the     femoral head and creates a new cavity to be filled in by healthy bone. This trial will use     hip decompression plus saline injection in one hip and hip decompression supplemented with     adipose derived regenerative cells in patients with osteonecrosis in both of their hips.   "
255197|NCT03270631|"     Subjects are recruited from the attendees of the multidisciplinary low back pain     rehabilitation group before it takes place in University Hospital of Oulu at Physical and     Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks     before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor     at PRM unit. The volunteered subjects are invited to the briefing of the study and those who     are willing to participate, they filled in several questionnaires about pain, participation,     disability and mood. After that the subjects are measured at baseline measurement. Subjects     are randomized into the five groups. After the 3 months treatment and training the follow-up     measurements are performed. Same questionnaires are filled in at that point as well. At 6 and     12 months the follow-up questionnaires (same as before) are sent to subjects.   "
255187|NCT03269370|"     Anxiety disorders are among the most common psychological disorders, with prevalent onset in     childhood and adolescence. While cognitive behavioral therapy (CBT) is considered the     first-line treatment for pediatric anxiety, significant barriers remain in accessing CBT and     other evidence-based treatments (EBTs), and credible self-help resources based in EBT     concepts. This study evaluates a family-guided CBT game application (Anchors App), targeted     to children ages 6-11 and their families, which focuses on delivering adaptive CBT-based     coping skills to those who have sub-clinical to mild anxiety and related symptoms in a     convenient and portable platform. Anchors App will be evaluated in two forms (standard and     parent-enhanced) in comparison to use of a self-help book or waitlist control. The rapid     advancements in technology allows richer interactive capacity, content scalability,     customizability, and subscription to a broader range of content, which this app capitalizes     on in order to increase access to CBT skill concepts directly to pediatric stakeholder     populations. If found to be effective, Anchors App has the opportunity to promote engagement     of EBT concepts in every-day use through smartphone technology, and will change the landscape     of mental health prevention and early intervention for children and families.   "
255304|NCT03269175|"     The purpose of this study is to obtain long-term clinical data from patients approximately 15     years after their first clinical event, who participated in the former BENEFIT 304747 study     and were treated at least once within that study.      This study will collect clinical information on the disease course, on disability, relapses,     cognitive function over time, quality of life, depression, fatigue, resource use, and     employment status. In addition, brain MRI is performed.   "
255188|NCT03268304|"     Introduction: In the recent past, medical training systems using virtual reality (VR) have     been introduced to neurorehabilitation to train motor function deficits in patients. The     usage of VR-based training systems is based on the evidence of neuroplasticity, which is     responsible for recovery of patients suffering from motor dysfunction. Such systems are     increasingly used to encourage purposeful limb movements in a VR environment and its efficacy     has been found comparable with conventional therapeutic intervention. VR training systems,     e.g. the YouGrabber® (YG), will increasingly also be used at home. Therefore, it is essential     to integrate valid and reliable assessment tools to monitor the recovery process.      Objectives: The aim of the clinical study is to evaluate the usability, feasibility and     validity of the digital version of the ActionResearchArmTest (d-ARAT) using the YG system as     a platform. Additionally, the feasibility and usability of the implementation of two     rehabilitation measures that only recently became integral part of neurorehabilitation, e.g.     Action Observation (AO) and Motor Imagery (MI), into the YG training software will be     evaluated. Patients & methods: This observational study is designed as a single-arm trial for     testing the assessment software including pre- to post rehabilitation comparison either with     additional training involving AO and MI or with no additional training. Therefore, 75 adult     patients with Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré     syndrome will be included. 30 out of the 75 patients will take part in the additional 4-week     training on the enhanced VR-based system with a total of 16 training sessions of 45 min each.     Primary outcomes will be the score on the System Usability Scale (SUS) and the ARAT as well     as the d-ARAT scores. Secondary outcomes will be hand dexterity (Box-and-Block Test), upper     limb activities of daily living (CAHAI) and quality of life (EQ-5D-5L).      Results & conclusions: The study was designed to evaluate the d-ARAT and the training     software modules for the YG system. Currently AO and MI specific tasks are being integrated     and the ARAT subscales will be implemented on the basis of the redesigned glove equipped with     new sensors. The results are expected to give recommendations for necessary modifications.     They might also contribute knowledge concerning the application of AO and MI tasks within VR     training.   "
255190|NCT03269942|"     The investigator expects that endovascular flow-diversion is superior over revascularization     by postoperative modified Rankin scale (mRS) in patients with complex intracranial aneurysms.   "
255191|NCT03268681|"     Biotinidase is an enzyme that recycles biotin, a water-soluble vitamin essential as a     coenzyme for four carboxylases that are involved in gluconeogenesis, fatty acid synthesis,     and in the catabolism of several branch-chain amino acids. Biotinidase deficiency (BD) is an     autosomal recessively inherited disorder. Patients with profound BD (<10% of mean normal     serum biotinidase activity) presents, usually during early childhood, with neurological     (seizures, hypotonia, ataxia, developmental delay, vision problems, and/or hearing loss) and     non-neurological findings (metabolic acidosis, respiratory difficulties, alopecia and/or skin     rash) that may progress to coma or death if untreated.      Three cases of adult-onset biotinidase deficiency with reversible optic neuropathy have     recently been described in France, where there is no neonatal screening of BP. Once treated     with Biotin, patients' vision was fully restored.      This study aims to assess the prevalence of BP among a population of patients with idiopathic     optic neuropathy, and to assess the efficacy of Biotin supplementation on visual impairment     in these patients.   "
255192|NCT03269630|"     Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery     pressure >=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes     are still sub-optimal and further research is required into the pathobiology of the disease     and development of biomarkers that can guide clinical care. The investigators are     establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary     hypertension, patients at high risk for pulmonary hypertension, healthy controls, and     patients undergoing right heart catheterization. Specimens will be stored for future     investigations.   "
255194|NCT03269851|"     To detect risk factors of neurological deficit after thoracolumbar spinal fractures.   "
255196|NCT03269812|"     To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence     and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung     disease.   "
255201|NCT03268395|"     The purpose of this clinical investigation is to compare transcutaneous CO2 (TCCO2) levels     measured non-invasively using the SenTec Transcutaneous CO2 Monitor to PaCO2 levels measured     on arterial blood gas (ABG) samples in neonatal patients being treated for respiratory     distress in the Neonatal Intensive Care Unit (NICU) at Memorial University Medical Center.   "
255203|NCT03270306|"     This case-control study aims to compare the differences in eating behaviours, nutritional     status, diet quality and gastrointestinal (GI) health between Chinese children aged 3-6 years     with autism spectrum disorders (ASD) (n=65) and typically developing children (TDC) (n=65).   "
255204|NCT03268174|"     The purpose of this study is to observe the performance of a cosmetic product, AO+Mist, on     the appearance of arm skin in subjects with atopic dermatitis   "
255205|NCT03268967|"     Admission to the intensive care unit (ICU) is vital for surviving critical illness. An     admission to ICU without having a consistent structure, structured review of the patient and     a solid team organization lead to unclear communication and responsibility. Factors that     correlate with patient acceptance and safety, morbidity and mortality. We hypothesized that a     structured admission can improve patients safety, reduce delays in treatment, reduce ICU     length of stay, and improve mortality rate. The overall objective was to optimize patient     safety, and effectively use available resources to reduce admission time, delays in treatment     and procedures and mortality by using both quantitative and qualitative methods.   "
255206|NCT03270241|"     This is an amendment for the Research IRB00052103 Randomized, Split-Body, Single-blinded     Clinical Trial of Narrow Band-Ultraviolet B (NB-UVB) Treatment for Vitiligo.      Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients'     quality of life across all degrees of involvement and severity. The molecular and cellular     analysis of vitiligo showed a difference in molecular expression and cellular behavior as     compared to normal skin. Phototherapy, such as Narrow band UVB (NB-UVB), is a clinically     indicated treatment for skin lesions. NB-UVB treatment has been shown to promote     repigmentation and normalize cellular behaviors.   "
255207|NCT03269799|"     Periodontitis patients with uncontrolled type 2 diabetes mellitus will receive non-surgical     periodontal treatment and then be supplemented with daily 500 mg vitamin C (test group) or     placebo (control group) for 2 months. Clinical parameters will be retrieved at baseline, at     the end of week 4 and at the end of week 8.   "
255208|NCT03266302|"     Infective endocarditis (IE) is associated with high hospital mortality for various reasons;     one of them is circulatory failure in patients who undergo cardiac surgery for IE. One     discussed reason underlying circulatory failure during surgery is the release of     vasodilatatory mediators and cytokines. This study examines the efficacy and safety of a     hemoadsorption filter which is approved for the reduction of the concentration of cytokines     in the bloodstream.   "
255210|NCT03269877|"     The spleen could be considered a neglected organ. To date, it has been deemed an ancillary     organ in portal hypertension or an organ localization in lymphoproliferative diseases.     Hypersplenism is a common disorder characterized by an enlarged spleen which causes rapid and     premature destruction of blood cells. It can result from any splenomegaly. It is most common     with splenomegaly secondary to portal hypertension and hematological disorders. Portal     Hypertension is an important cause of splenomegaly in most tropical countries This work will     involve a series of studies aiming to:        1. Assess the prevalence and pattern of hypersplenism, and grade the severity of cytopenias          in patients with cirrhosis and portal hypertension.        2. Elucidate the relationship between hypersplenism, in these patients, and:             1. The severity of liver cirrhosis as assessed by Child's and the Model of End-stage               Liver Disease (MELD) scores.             2. The presence and grade of gastroesophageal varices as assessed by upper endoscopy.             3. The presence of hepatocellular carcinoma             4. Portal hemodynamics and portal vein thrombosis as assessed by Doppler Ultrasound.        3. Test the hypothesis that leucopenia in cirrhotic patients may be caused, at least in          part, by apoptosis of polymorphnuclear leucocytes.   "
255212|NCT03268512|"     A split-mouth design study will be performed regarding the use of platelet concentrates on     ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in     the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate     or control will be randomized by means of a computer program. The results will be analysed     clinical and radiographically (CBCT). When the subject will choose for implant     rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will     be localized with a customized stent, fabricated with the position of the extracted teeth.     VAS scales will be provided to evaluate the post-operative discomfort.   "
255213|NCT03268239|"     Gadolinium-enhanced magnetic resonance imaging (MRI) is currently the imaging gold standard     to detect active inflammatory lesions in multiple sclerosis (MS) patients. The sensitivity of     enhanced MRI to detect active lesions may vary according to the acquisition strategy used     (e.g., delay between injection and image acquisition, contrast dose, field strength, and     frequency of MRI sampling). Selection of the most appropriate T1-weighted sequence after     contrast injection may also influence sensitivity. Several clinical studies performed at 1.5     Tesla have shown that conventional 2D spin-echo (SE) sequences perform better than gradient     recalled-echo (GRE) sequences for depicting active MS lesions after gadolinium injection. As     relates to MS, 3.0 Tesla systems offer some advantages over lower field strengths, such as     higher detection rates for T2 and gadolinium-enhancing brain lesions, an important capability     for diagnosing and monitoring MS patients. Recent studies have shown that at 3 Tesla, 3D GRE     or 3D fast SE sequences provide higher detection rates for gadolinium-enhancing MS lesions,     especially smaller ones, than standard 2D SE, and better suppress artefacts related to     vascular pulsation. However, the comparison of the performance of 3D GRE versus 3D SE     sequences has not been investigated yet.      Objectives To compare the sensitivity of enhancing multiple sclerosis (MS) lesions in     gadolinium-enhanced 3D T1-weighted gradient-echo (GRE) and turbo-spin-echo (TSE) sequences.   "
255214|NCT03266341|"     Early detection of anaerobic bacteria to avoid its serious comlications   "
255215|NCT03268460|"     Providing summarized information on the clinical and biochemical characteristics and types of     renal tubular acidosis in children in Assiut University Childern Hospital.   "
255216|NCT03267433|"     This randomized phase III trial studies rituximab after stem cell transplant and to see how     well it works compared with rituximab alone in treating patients with in minimal residual     disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies,     such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving     chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body     and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to     grow. After treatment, stem cells are collected from the patient's blood and stored. More     chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem     cells are then returned to the patient to replace the blood-forming cells that were destroyed     by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in     treating patients with mantle cell lymphoma.   "
255218|NCT03269500|"     Describe the frequency of use of nutrition education tools for undernourished older people   "
255219|NCT03266731|"     Role of anti-platelet in treatment of acute ischemic stroke to determine the safety of     immediate anti-platelet therapy .that is started as soon as possible within the first 24     hours of the onset of symptoms.   "
255221|NCT03269292|"     Autoimmune hemolytic anemia is characterized by shortened red blood cell survival and a     positive Coombs test. The responsible autoantibodies may be either warm reactive or cold     reactive. The rate of hemolysis and the severity of the anemia may vary from mild to severe     and life-threatening. Diagnosis is made in the laboratory by the findings of anemia,     reticulocytosis, a positive Coombs test, and specific serologic tests. The prognosis is     generally good but renal failure and death sometimes occur, especially in cases mediated by     drugs.   "
255222|NCT03269448|"     Observational study to analyze correlation between partial pressure of carbon dioxide from     blood obtained from peripheral and central veins   "
255227|NCT03268629|"     The primary objective of this proposed three-year (January 01, 2018 to December 31,2020)     project is to verify the effect of 'Joyful Sleep' intervention on young and middle-aged     patients with insomnia in China and preliminarily explore the genetic level inflammation     mechanism for the treatment of insomnia applied by it. Previous researches show that     Mindfulness-Based Interventions may relieve insomnia, it is hypothesized that 'Joyful Sleep'     will be an effective, feasible and affordable insomnia reduction program in China.   "
255228|NCT03269838|"     To correlate QT dispersion on 12-lead surface ECG with myocardial reperfusion evaluated by     myocardial blush grade and Thrombolysis in myocardial infarction (TIMI) flow grades in     patients with ST elevation myocardial infarction treated by Primary Per cutaneous coronary     intervention   "
255328|NCT03230448|"     There is a strong link between the alcohol consumption and the suicidal risk. Indeed there is     an increase of the risk of suicide in case of chronic or acute alcohol consumption. However     why the alcohol consumption increase the suicidal risk is unknown.      The hypothesis of this study is that the alcohol consumption induced disinhibition and     facilitates the suicide attempt without premeditation   "
255230|NCT03269058|"     This study will make it possible to better understand the mechanisms responsible for the     increase in bad cholesterol levels observed in patients with type 2 diabetes treated with     Dapagliflozin, an antidiabetic treatment made by Astrazeneca.      The information will:        -  reveal what is not working properly        -  make it possible to choose the most appropriate treatments against cholesterol to          compensate for this impaired functioning      This biomedical research will take place at the University Hospitals of DIJON and NANTES.        -  28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will          be given the placebo.        -  The study treatment will be randomised: patients will be given either Dapagliflozin or          the placebo. The treatment duration is 6 months.        -  Moreover, during the inclusion visit and at the end of the study (6 months after the          start of treatment), a kinetics study, to follow the production and elimination of          cholesterol, will be conducted. This will involve administering amino acids that have          been specifically synthesised for this purpose.        -  Participation in the study will last 6 months and include 4 protocol visits.   "
255232|NCT03269357|"     Training of health care providers and structured LARC forward counseling may contribute to     increased LARC uptake. The hypothesis to be tested is that by introducing LARC forward     counselling an increase in LARC usage will be the result as well as decreased unplanned     pregnancy and abortion. It is expected that the results of this study will highlight the     importance of LARC forward counseling and thus provide the evidence needed to train health     care providers and increase access to LARC in youth clinics, midwifery clinics and for post     abortion contraception.   "
255233|NCT03268590|"     The investigators will conduct a non-randomized clinical trial to examine the effect of pure     oxygen breathing on the brain. The study will compare cerebral blood flow, cortical     electrical activity, and cognitive performance in 32 persons during room air (21% oxygen)     breathing and pure oxygen (100% oxygen) breathing. Subjects will be used as their own     controls. The investigators aim to:        1. Determine whether breathing 100% oxygen changes blood flow through the brain. The          investigators will learn whether brain blood flow is increased, decreased or stays the          same.        2. Determine if changes that might occur in brain blood flow are also accompanied by          changes in the brain's electrical activity (EEG).        3. Learn whether changes in the speed at which the brain processes information (cognitive          function) accompany changes in brain blood flow and electrical activity that may be          seen.   "
255235|NCT03270943|"     The rate of depression increases markedly over the course of adolescence. Adolescents     struggling with depression are often set on a maladaptive behavior trajectory which may lead     to academic challenges, substance abuse, risky sexual behavior, impairment in relationship     building, and suicidality. The S.M.A.R.T Project (Stress Management and Resilience Training     for Teens) is designed to learn about mood in teens, and whether emotional well-being can be     improved with an 8 week class. The study proposes to refine and test the feasibility of a     mindfulness-based self-compassion training program for adolescents who are experiencing     subsyndromal depression, comparing it with a healthy lifestyles group program as a     comparison attention-control for the treatment intervention. Secondarily, the study will     explore the impact of these programs on measures of psychopathology and well-being (i.e.     depressive symptoms and resilience).   "
255236|NCT03268447|"     This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for     brain health properties, primarily alleviation of stress, among adults in Malaysia aged from     18 to 60 years.   "
255237|NCT03268928|"     The aim of this project is to evaluate whether Beanstalk's 'Story Starters' intervention is     effective in boosting vocabulary and grammatical development in young children.   "
255239|NCT03269461|"     Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in     patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.   "
255240|NCT03263806|"     This study is designed to directly compare Standard Care and CT fractional flow reserve     (CT-FFR) for diagnosis of chest pain patients with definite coronary artery disease (CAD) on     heart computed tomography (CT) scans.   "
255241|NCT03270748|"     The experimental treatment consists in the application of a therapeutic strategy with post     Transplant High-Dose Cyclophosphamide as GvHD Prophylaxis in Patients Receiving     1-Antigen/Allele HLA Mismatched (7/8 matched) Unrelated Hemopoietic Stem Cell Transplantation     for Myeloid Malignancies.   "
255242|NCT03270761|"     This is a multi-center study to report the demographic profile, clinical features, and     management in patients with Iridocorneal endothelial (ICE) syndrome in China.   "
255243|NCT03268369|"     Mutations in neuronal nicotinic acetylcholine receptors (nAChRs) have been identified in the     autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE). Despite the demonstration of a     gain of function of the mutated receptors, the precise mechanisms leading to this nocturnal     epilepsy are still unknown. In 2006 the investigators studied the nAChR cerebral distribution     in a group of patients with ADNFLE carrying a nAChR mutation, by a PET-scan using     [18F]-F-A-85380, a ligand with a high affinity and specificity for alpha4beta2 nicotinic     receptors. The study showed a different pattern of brain distribution of the radiotracer in     the ADNFLE patients when compared to a group of control subjects, with a significant increase     of nicotinic receptor density in the patients in mesencephalon and cerebellum (Picard et al.,     Brain 2006). Based on the known biochemical and cellular circuits in the brainstem, these     results suggest that the nAChR density increase in mesencephalon is involved in the     pathophysiology of ADNFLE through the role of brainstem ascending cholinergic systems in     arousal. The follow-up step consists of extending this examination to other forms of     epilepsy, in order to verify the specificity of the hyperfixation pattern for ADNFLE, and     search for a potential involvement of nicotinic receptors in other forms of epilepsy. The     investigators aim to study 5 groups of subjects: control subjects (Group 1, 20 subjects);     patients with a non lesional partial epilepsy and a predominance of diurnal seizures (Group     2, 12 subjects); patients with an idiopathic generalized epilepsy (Group 3, 12 subjects);     patients with nocturnal frontal lobe epilepsy (Group 4, 3 subjects) and epileptic patients     with vagal nerve stimulation (Group 5, 1 subject). For each patient, a cerebral MRI, [18F]-     fluorodeoxyglucose (FDG) PET/CT and [18F]-F-A-85380 PET/CT examinations are planned. The     investigators will perform data analyses on volume of distribution (Vt) parametric images     which will be based on the ratio of brain tissue to unchanged F-A-85380 plasma at     equilibrium. Statistical parametric mapping (SPM2) will be used to further study the     parametric PET images. This study is primarily dedicated to demonstrate that the pattern of     hyperfixation that was obtained in ADNFLE patients is specific for this disorder and does not     constitute a common pattern to various forms of epilepsy. The investigators will also search     for a possible involvement of the nAChRs in other forms of epilepsy.   "
255348|NCT03223311|"     Since the development of custom-made fenestrated and branched endografts a novel therapeutic     option for the management of thoracoabdominal and para-renal aortic aneurysms was made     accessible. Because of the design of these branched endografts, an arterial vascular access     from the upper limb is required to allow selective catheterization of the branch component     and the respective target vessel (celiac trunk, superior mesenteric artery, renal artery).2   "
255246|NCT03269240|"     The aim of this study is to compare the effectiveness and cost of a simulation-based low dose     high frequency (LDHF) plus m-Mentoring training versus the traditional group-based training     approaches in improving knowledge and skill in maternal and newborn care and to determine     trainees' satisfaction with the approaches in Ebonyi and Kogi states.      The specific objectives are to:        1. Compare knowledge and skill learning outcomes between the two groups of birth attendants          trained through the simulation-based LDHF/m-Mentoring versus group-based training          approaches in Kogi and Ebonyi states over 12-months.        2. Assess the trainees' satisfaction with a simulation-based LDHF/m-Mentoring and          group-based training approaches in improving skills of birth attendants in the selected          facilities in Kogi and Ebonyi state over 12-months.        3. Determine the cost and cost-effectiveness of LDHF/m-Mentoring and group-based training          approaches in improving skills of birth attendants in the selected facilities in Kogi          and Ebonyi state over 12-months.   "
255248|NCT03268226|"     The purpose of this study is to evaluate the effect of inhaled extrafine CHF5993 pMDI on     airway volumes, and resistance, by Functional Respiratory Imaging (FRI), in COPD patients   "
255250|NCT03267498|"     This is a Phase 2, single arm, open-label, multicenter study evaluating the feasibility of a     treatment regimen comprised of nivolumab administered approximately every 2 weeks before and     during chemoradiation and as an adjuvant therapy for 3 months to patients with stage II-IVB     NPC who are planning to undergo chemoradiation treatment of their cancer.   "
255251|NCT03269955|"     Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of     strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of     this study is to compare the incidence of pancreatic fistula that is most crucial for     surgical outcome and complications in pancreaticoduodenectomy with those of the control group     and the TachoSil® apply group.      Patients who were planned to undergo pancreaticoduodenectomy without a history of chronic     pancreatitis are enrolled in this open-label, single-center, randomized, single-blind, phase     4 clinical trial.   "
255252|NCT03270969|"     Human immunodeficiency virus (HIV) persists worldwide as an immense health burden among     vulnerable populations. HIV pre-exposure prophylaxis (PrEP) has offered the promise of     limiting the global burden of HIV. The objective of this proposal is to conduct a     pharmacokinetic (PK) study in transgender women to describe the pharmacokinetics of tenofovir     disoproxil fumarate/emtricitabine (TDF/FTC) as PrEP within this population.   "
255253|NCT03268408|"     Not-randomized controlled study to evaluate a community intervention to promote self-efficacy     parenting. The treated group will be composed by all newborns resident in S.Ilario d'Enza     (105 in 2013) where the Baby Newsletter is implemented. Newborns resident in the Health     District of Montecchio and born in Montecchio Hospital in the same period are the control     group (278 in 2013). Preterm or hospitalized children are excluded.      Self-efficacy parenting is evaluated through a questionnaire administered at baseline, after     5 and 12 months.   "
255255|NCT03270696|"     This study is conducted to evaluate the efficacy of simultaneous injection of propofol and     rocuronium in inducing general anesthesia.   "
255258|NCT03267550|"     Remote programming has significant advantages over conventional programming methods on some     issues. This research will test the safety of SceneRay remote and wireless DBS programming     system.   "
255260|NCT03265652|"     The aim of the current study is to examine the contribution of intense pulsed light (IPL) for     relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL     will be examined in a study designed as a randomized controlled trial. In the study arm,     subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by     expression of the meibomian glands. In the control arm, subjects will undergo the same     treatments, except that the IPL pulses will be disabled. For each subject, the duration of     the study will be 10 weeks, as explained in the detailed description,   "
255261|NCT03268473|"     The main objective of this study is to investigate whether the non-surgical periodontal     treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects     the prognosis of OSAS positively with polysomnographic, serum and saliva parameters.   "
255262|NCT03269305|"     The study is to assess whether the staff in gastroenterology unit are sticking to the agreed     up on unit's protocol in management of chronic diarrhea over the period of one year(september     2017-september 2018)   "
255263|NCT03269331|"     The Institute of Medicine's (IOM) ambitious goal for at least 90% of clinical decisions to be     evidence-based includes nursing interventions and practice. Models and frameworks have been     developed to meet the demand for practice transformation. While magnet facilities require a     commitment to evidence-based nursing practice, military facilities currently lack such a     requirement but are instituting evidence-based practice (EBP) initiatives in a purposeful     path toward developing high-reliability organizations. Currently, little is known regarding     the effectiveness of specific EBP models and frameworks within the military culture. The     purpose of this investigation is to determine the effectiveness of the Advancing Research and     Clinical Practice through Close Collaboration (ARCC) model in an Air Force Medical Treatment     Facility (MTF) beginning with nursing services.      Research questions:        1. What is the current state of organizational culture and readiness for EBP within the          MTF's nursing services?        2. Will utilization of the ARCC model significantly improve EBP beliefs, knowledge, and          practice in MTF nurses over a two-year period?        3. Is the ARCC model feasible for implementation in Air Force MTF's?      This study includes an intervention group (n=70) of active duty nurses and technicians who     attend an intensive 5-day EBP Immersion Workshop and a control group (n=70) who do not. The     intervention group will have access to specialized resources such as: a) Center for     Transdisciplinary Evidence-Based Practice (CTEP) expert EBP mentors, b) EBP toolkit and     resources, c) one year of free access to the Ohio State University (OSU) virtual library.     Control group participants will have standard MTF education opportunities. Established valid     and reliable survey measures (EBP attitudes, knowledge, beliefs) will be hosted     electronically by CTEP at baseline, three, and twelve months. Online measures include     institutional and nursing process measures (EBP implementation, policy changes, and     publications) over the two-year study period. De-identified data from the anonymous survey     measures will be shared by CTEP with this study team. Data analysis will include T-tests or     Mann Whitney U test for group comparisons. Repeated measures ANOVA or the nonparametric     equivalent, Friedman's test will be used to compare three time points within groups.     Feasibility metrics and demographics will be reported with descriptive statistics.   "
255298|NCT03269526|"     This protocol will confirm toxicities and estimate the clinical efficacy of combining     anti-CD3 x anti-EGFR bispecific antibody (EGFRBi) armed activated T cells (EGFR BATs) given     to patients with locally advanced or metastatic pancreatic cancer who have received at least     one dose of first line chemotherapy and may have responding, stable or progressive disease.     Phase Ib will confirm a safe dose of 8 infusions, given twice weekly, of EGFR-BATs in 3 to 6     subjects. The phase II portion of the trial will test the clinical efficacy of this dose in     22 patients (including those in Phase Ib).   "
255264|NCT03266224|"     Torticollis is a clinical sign or symptom that could be the result of a variety of underlying     disorders. Among the etiologies, Congenital muscular torticollis (CMT) with impairment of the     sternocleidomastoid (SCM) is the most frequent cause of torticollis in infants. CMT is a     postural deformity detected at birth or shortly after birth, primarily resulting from     unilateral shortening and fibrosis of the SCM. Infants with CMT display head tilt to one     side, which is often combined with rotation of the head to the opposite side. In 2002,     Chih-Chin Hsu et al. reported that CMT could be classified into four types. The majority of     Type I and II fibrosis improved after conservative treatment. However, Type III and Type IV     had more probability in need of surgical correction. However, this categorization lacks of     objective and quantitative measurement and can be different by subjective judgement of     different physicians. The purpose of this study is tried to perform digital analysis of     ultrasonography images to establish an objective, quantitative method and to assess its     relevance with clinical symptoms and prognosis.      This study will collect the children younger than one year-old who were impressed or     suspected to have torticollis in physical medicine and rehabilitation clinic to assess the     relationship between digitalization results of ultrasound image and clinical manifestations     and prognosis. Digital image analysis of ultrasound which contains both sides of the SCM in     transverse and longitudinal view for comparison of lesion side and sound side will be     performed after the initial enrollment and every six months later. Evaluation of clinical     manifestations includes measurement of side difference of angles in bilateral neck lateral     flexion, rotation and habitual head position will performed using an arthrodial protractor by     a trained member at the beginning of physical therapy and one month later, then every 2-3     months. All cases will be followed for 1 and a half years. We expect to find some typical     characteristics of CMT through digital analysis of the SCM. These characteristics include the     muscle thickness and intensity of echogenicity in the region of interest. The Pearson's     correlation will be performed to analyze the relevance of quantitative side differences in     ultrasonography and clinical manifestations including side differences of neck rotation,     lateral flexion and habitual head position between lesion sides and sound sides.   "
255280|NCT03269513|"     The study aims to evaluate the possible effects of an exercise program, nutritional and     psychological, postural orientation and guidance of oral health on body composition, physical     activity levels and lifestyle, physical fitness and health and motor performance, the factors     risk of cardiovascular disease, eating habits, the cognition levels, the psychological     profile, the body posture of children and adolescent with overweight and obesity, considering     the presence of risk genotype associated with the development of obesity. In addition,     identify the effects of orientation for oral health on the quality of life and healthy oral     habits.   "
255281|NCT03260426|"     Prospective randomized controlled trial investigating commencement of low residue diet versus     clear liquids on postoperative zero following elective colorectal surgery, with regards to     patient tolerability, incidence of nausea and/or vomiting, and postoperative length of     hospitalization stay.   "
255266|NCT03268525|"     The investigators aim is to study the effect of pre-operative local anesthetic on post     vaginal hysterectomy pain.   "
255269|NCT03268850|"     This study aims to evaluate the effectiveness of offering reimbursement for living donor lost     wages on the rate of live donor kidney transplantation.   "
255272|NCT03269474|"     The study will compare gene expression differences between blistered and non-blistered skin     from individuals with EBS, as well as normal skin from non-EBS subjects. State of the art     computational analysis will be performed to help identify new drugs that might help EBS wound     healing and reduce pain. Researchers will focus on drugs that have already been approved for     treatment of other dermatologic or non-dermatologic diseases, and therefore be repurposed for     treatment of EBS. Drug development is a very expensive process taking decades for execution.     Drug repurposing on the other hand, significantly reduces the cost and shortens the amount of     time that is needed to bring effective treatments to clinical use. To date, there is no     specific treatment targeting the physiology and immunologic response in EB patients during     wound healing. Market availability of repurposed medications will provide EBS patients rapid     access to treatments, thus improving their quality of life.   "
255275|NCT03257631|"     A Phase 2 study that will assess the efficacy, safety and tolerability of pomalidomide in     children and young adults aged 1 to < 21 years with recurrent or progressive primary brain     tumors.      The study will consist of 4 parallel groups, one for each of the following primary brain     tumor types: high-grade glioma, medulloblastoma, ependymoma and DIPG. A Simon's Optimal     two-stage study design will be applied to each group.   "
255276|NCT03270722|"     FLIP topography has been FDA cleared to evaluate a variety of esophageal conditions, but has     never been evaluated in patients with scleroderma. The investigators hope to evaluate this     technology in patients who have scleroderma and various esophageal symptoms, and compare to     non-scleroderma patients.   "
255279|NCT03269435|"     We are comparing a type of nerve block called greater occipital nerve block versus standard     therapy among patients who present to an emergency department for acute migraine. This is a     randomized, double-blind, double dummy study. The greater occipital nerve block will be     performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.   "
255499|NCT03053297|"     This is an observational cohort study of patients with locally advanced or metastatic NSCLC     (non-small cell lung cancer).      Patients will be recruited from participating sites in Europe, Asia, and Canada. The study     will include 2 patient cohorts.   "
255289|NCT03266848|"     This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the     method with first-in-human studies.   "
255292|NCT03252457|"     The project was undertaking by Qilu Hospital of Shandong University and other 4 well-known     hospitals in China. In order to report the efficacy and safety of decitabine combining with     dexamethasone for the treatment of adults with immune thrombocytopenia (ITP), compared to     dexamethasone alone .   "
255293|NCT03255317|"     The aim of this study is to evaluate the efficacy of engagement strategies for increasing     daily data collection adherence among substance-using youth between the ages of 14 and 24.     The primary hypotheses of this study are that: (1) receiving a reinforcer after completing     daily data collection activities will predict next-day completion of targeted data collection     activities; and (2) receiving a notification prior to 6pm (when data collection activities     open) will predict same-day completion of data collection activities.   "
255295|NCT03255434|"     Cytotoxic chemotherapy is usually scaled to the body surface area (BSA), and is currently not     adjusted to the body proportions of lean and fat (i.e. body composition) of individual     patients. Patients with low muscle mass behave like patients overdosed with chemotherapy     resulted in dose-limiting toxicities (e.g. dose reductions, treatment delays or permanent     treatment discontinuation), independently of the patient's weight.   "
255300|NCT03250052|"     The purpose of this study is to evaluate pharmacokinetic interactions and safety between     fimasartan and linagliptin in healthy male volunteers.   "
255305|NCT03249116|"     Adolescence and young adulthood is a critical period for the development of social anxiety,     which is often linked to other mental health challenges such as depression, mood disorders,     and substance abuse. Initial evidence suggests that interacting with animals can reduce     stress and anxiety, but no research has tested whether this benefit extends to adolescents at     risk for social anxiety disorder. Additionally, researchers and clinicians do not understand     what mechanism is responsible for anxiety reduction in animal-assisted interventions (AAIs).     Therefore, the objectives of this study are to explore the specific mechanisms by which     interacting with a therapy dog reduces anxiety, and to test whether such an interaction     reduces anxiety in adolescents with varying levels of social anxiety.   "
255307|NCT03245515|"     The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.   "
255308|NCT03249753|"     This study is a single-center, randomized, open, double-cycle and double-cross and     self-reflection phase Ic clinical trial, to evaluate effect and safety of high fat diet on     pharmacokinetics of SPH3127 tablets.      Two panels, each consisting of ten participants (The number of single-sex subjects is not     less than 1/3 of the total number) will be randomized to A or B groups.   "
255309|NCT03255993|"     This study was a single center, parallel, randomized, double blind, placebo-controlled phase     Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127     tablet in healthy subjects by increasing multiple dosing   "
255337|NCT03269929|"     This study aimed to compare the efficacy of music therapy and midazolam 0,02 mg/kgBW in     reducing preoperative anxiety on patients undergoing brachytherapy with spinal anesthesia   "
255310|NCT03249493|"     As of today, HIV-infected patients followed in decentralized area have little or even no     access to viral load monitoring because laboratories able to perform this biological     measurement are only in large cities, and because plasma transfer to these laboratories is     complex and very costly.      Blood sampling using dried blood spots (DBS) could overcome these difficulties. The goal of     this operational research is to document the feasibility of DBS use in decentralised area to     monitor viral load, to evaluate the virological response on ART, and to compare the     virological response between injecting drug users (IDU) and the other patients, as IDU     represent a large proportion of HIV-infected patients who may have a lower access/adherence     to care.   "
255311|NCT03269396|"     The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal     allograft transplantation in an effort to safely use these procedures as a viable     reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.   "
255313|NCT03270085|"     To compare with a randomized trial (n=15 per treatment group), effects of colesevelam and     placebo treatment, on colonic transit, bowel functions, permeability and tight junction     expression in rectosigmoid mucosa of IBS-D with Bile Acid Malabsorption.   "
255315|NCT03239626|"     To investigate the acute toxicities, late toxicities, and treatment results when the early     cervical cancer patients are treated by hypofractionated intensity-modulated radiotherapy     (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.   "
255316|NCT03239613|"     To investigate the acute toxicities, late toxicities, and treatment results when the early     cervical cancer patients are treated by concurrent chemotherapy with hypofractionated     intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical     hysterectomy.   "
255317|NCT03269487|"     This study is part of the 5-year long (2013-18) PERFECTED (Peri-operative Enhanced Recovery     hip-fracture Care of paTiEnts with Dementia) National Institute for Health Research (NIHR)     funded research programme.      PERFECTED's aim is to develop and pilot an evidence-based intervention to improve the     hospital care of patients living with dementia who have fractured their hip. This protocol     relates to Work Package 2 (WP2) of PERFECTED only.      By working collaboratively with local clinicians and stakeholders, an action research     (plan-do-study-act) approach will be used to generate knowledge to understand how to best     implement the intervention (PERFECTED Enhanced Recovery Pathway), which was developed from     learning and research undertaken as part of Work Package 1. During the current study the     PERFECTED Enhanced Recovery Pathway (ERP) will be used to optimise care on three     ortho-geriatric wards for 12 months. These wards are located in Norfolk, Nottinghamshire and     Yorkshire. The sole participants are NHS personnel delivering care on selected wards.      Data collection activities (observations, in-field interviews, documentary analysis and     quantitative data generated from the PERFECTED ERP implementation checklist) will determine     the staff training and cultural changes required to implement and maximise adherence to the     PERFECTED ERP. Simultaneously, enabling the identification and exploration of areas of     optimised, satisfactory and sub-optimal care. By working in partnership within and across the     partner wards, action plans to address sub-optimal care will be generated, implemented and     reviewed. Findings will inform the best ways to optimise care via the implementation of the     PERFECTED ERP. Knowledge generated during this study will be used to develop an ERP and staff     training manual. This will aid implementation of the intervention arm of a latter Cluster     Randomised Control Trial (Work Package 3), ensuring the PERFECTED ERP can be utilised in the     real world.      As part of PERFECTED's commitment to Public Patient Involvement (PPI), lay researchers will     be trained to assist with qualitative research activities.   "
255319|NCT03269617|"     The PHAGE study is designed to determine if a commercial prebiotic product can change the     composition of bacteria in the gut for improved intestinal health. A prebiotic is defined as     an indigestible dietary component that selectively enhances specific bacterial species in the     intestines to confer a health benefit. In this study, the prebiotic a unique combination of     bacteriophages, or viruses that infect bacteria. These phages are generally regarded as safe     for human consumption and work by infecting bad bacteria in the gut, which allows beneficial     bacteria populations to increase. The product, PreforPro, has shown to be effective in     culture-based and animal studies, but its efficacy has not been demonstrated in humans. The     goal of this study is to see if PreforPro consumption improves gut bacteria profiles in     individuals relative to a placebo control and is associated with reduced incidence and     severity of gastrointestinal distress.   "
255321|NCT03236493|"     This study is a phase 1 study of PF-06700841. PF-06700841 is being developed for treatment of     inflammatory bowel disease. The goal of the study is to assess the safety, tolerability,     pharmacokinetics and pharmacodynamics of PF-06700841 after multiple oral doses of PF-06700841     in Japanese healthy volunteers.   "
255323|NCT03261648|"     Evaluate and compare the impact of partner's stress in the pain of the patient admitted in     the emergency department   "
255324|NCT03270423|"     Randomised controlled trial in overweight adolescents using a health App.   "
255325|NCT03242837|"     This study evaluates the influence of a resilience training on psychobiological factors which     are related to stress and resilience in young healthy male cadets. Half of participants will     join in the resilience training, while the other half take part in a control-training     (diversity management training).   "
255327|NCT03233022|"     Participants complete an 8-week program and complete assessment measures to track their     outcomes over time.   "
255329|NCT03244527|"     In the past few years, Branched Chain Amino Acid (BCAA) supplements have gradually used on     different groups. From training athletes, maintaining functions of healthy elders to     preventing disabilities of people that can't do intense exercises. BCAAs are now considered     to be able to prevent muscle atrophy and strength loss, also possible to increase strength     and muscle mass if combined with resistance exercises. Stroke patients have difficulties with     moving, which led to multiple disabilities, are more likely to have sarcopenia and strength     loss. Furthermore, reducing the will of moving or walking. Recently, studies showed that     combined BCAAs with resistance exercises can effectively increase muscle mass, thus commonly     used on training athletes.      Although aerobic exercises are proven to be more likely to improve walking ability of chronic     stroke patients than traditional rehabilitation, BCAAs' effects are yet to be proven.     Therefore, the aim of this study is to explore if BCAAs combined with moderate intensity     exercises can prevent muscle atrophy, loss of strength and cardiopulmonary function.      This is a randomized control trial. Participants are randomly assigned to either experiment     or control groups. Both group received aerobic exercise (30 min in a session, 3 days a week,     and for 8 weeks). Experiment group received BCAA supplement immediately after the exercise     while the control group receive sham product (vitamins). The outcome measurements (including     muscle mass, functional measures, and quality of life) are performed before (0-wk) and after     (8-wk) the interventions.   "
255330|NCT03234465|"     The purpose of the study is to evaluate the efficacy, safety and tolerability of topically     administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients     undergoing chemoradiation for the treatment of head and neck cancer, as measured by the     duration, time to development, and overall incidence of OM during the active treatment phase,     beginning from the start of radiation therapy (RT) until 2 weeks following its completion.      The effect of AG013 on patient-reported symptoms and analgesic use during the active     treatment phase, and on the cumulative radiation dose administered before the onset of OM     will also be evaluated, as will biomarkers and, in a subset of subjects, the PK     (pharmacokinetic) profile of AG013.   "
255331|NCT03240523|"     The primary objective of this study is to assess the efficacy of vilaprisan in subjects with     uterine fibroids compared to ulipristal The secondary objective of this study is to evaluate     the efficacy and safety of different treatment regimens of vilaprisan in subjects with     uterine fibroids   "
255529|NCT03018405|"     THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase I     study to assess the safety and clinical activity of multiple administrations of autologous     NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian,     bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute     myeloid leukemia and multiple myeloma).      The trial will test three dose levels. At each dose, the patients will receive three     successive administrations, two weeks apart, NKR-2 cells. The dose escalation part of the     study will enroll up to 24 patients while the extension phase would enroll 86 additional     patients.   "
255530|NCT03016325|"     A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO     Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function   "
255342|NCT03234608|"     The health system is ill-equipped to meet the needs of autistic adults. The Academic Autism     Spectrum Partnership in Research and Education (AASPIRE), an academic-community partnership     comprised of academics, autistic adults, healthcare providers, and supporters, has used a     community based participatory research (CBPR) approach to develop and test an online     healthcare toolkit aimed at improving primary care services for autistic adults. It was     specifically designed as a low-intensity, sustainable intervention that can realistically be     used in busy primary care practices that do not have a special focus on autism or other     developmental disabilities. The toolkit includes the Autism Healthcare Accommodations Tool     (AHAT)--an automated tool which allows patients and/or their supporters to create a     personalized accommodations report for their primary care provider (PCP)--and other targeted     resources, worksheets, checklists, and information. The investigators' pilot work has     demonstrated that the AHAT has strong construct validity and test-retest stability, the     toolkit is highly acceptable and accessible, and it has the potential to decrease barriers to     care and increase patient-provider communication. The investigators' long-term plan is to     conduct a hybrid effectiveness-implementation trial, using a cluster randomized trial design,     both to test the effectiveness of the AASPIRE Healthcare Toolkit in improving healthcare     quality and utilization and to assess the utility of implementation strategies in diverse     healthcare systems. The objective of this proposal is to use a CBPR approach to understand     how to integrate the toolkit into these health systems, collect more robust efficacy data,     and explore potential mechanisms of action. The investigators will do so by conducting a     6-month pilot study with patients assigned to intervention and control clinics in three     diverse health systems. The investigators will meet our objectives by achieving the following     specific aims: 1) to determine how to integrate use of the toolkit within diverse health     systems; 2) to test the effect of the toolkit on short-term healthcare outcomes; 3) to use a     mixed-methods approach to further explore the toolkit's mechanisms of action; and 4) to     refine the recruitment, retention, data collection, and system integration strategies in     preparation for the larger cluster-randomized trial.   "
255343|NCT03269279|"     The goal of this study is to examine the effectiveness and feasibility of a     mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in     Burkina Faso.   "
255346|NCT03220074|"     A prospective open study to determine the efficacy and tolerability of oral linezolid     600mg./day for the treatment of 50 patients with nontuberculous mycobacterial diseases will     be conducted at Siriraj Hospital, Mahidol University, Bangkok, Thailand.   "
255347|NCT03269318|"     Asthma is one of the most common chronic diseases affecting children in the UK. Poorly     controlled asthma manifests with chronic cough, wheeze and shortness of breath which in-turn     has a significant negative impact on a child's quality of life, interfering with sleep,     impairing exercise ability and resulting in frequent school absences and hospital admissions.      Management of paediatric asthma in the UK is directed by the British Thoracic Society (BTS)     Guidelines, which recommend a stepwise (one to five) treatment plan. Step three of the     management guideline for children aged 5-12 years of age recommends the addition of the     preventer inhaled medication, including long-acting β2 agonists such as salmeterol. However,     there is a wide variation in response to this medication with approximately one in seven     people, with a specific genetic change, found to have an increase in asthma symptoms in     association with the use of thisiss medication. A related medicine, formoterol, is used less     commonly in children with asthma.      In this study, the investigators will aim to identify children with asthma whose symptoms are     poorly controlled on inhaled long-acting beta2 agonists. Via a simple saliva test, the     investigators will identify the presence or absence of the specific genetic change potentally     influencing the effectiveness of treatment with salmeterol or related longacting beta2     agonists thus enabling the investigators to recommend either salmeterol or an alternative     medication for the treatment plan such as montelukast. The investigators will randomise the     patients into two groups; to receive personalised care where the choice of controller     medication would be based on the child's gene test results and predicted response to     long-acting beta2 agonists, or standard care following the BTS guidelines at the     clinician's discretion without knowledge of the gene test results. The investigators aim to     measure whether this individualized approach to asthma prescribing results in improved     control of asthma symptoms and overall quality of life. Targeting treatment to a child's     specific genetic make-up is a concept known as personalised medicine.   "
255897|NCT02389140|"     The physiological response at the myofascial trigger point (MTrP) to massage is not known,     yet would provide important objective evidence for a treatment effect and clarify the     resolution process of a MTrP.   "
255349|NCT03213626|"     This is an open-label, single arm, phase II trial. Safety will be monitored on an ongoing     basis. Laboratory testing (chemistry, hematology tests) will be performed every 2 weeks for     the first 8 weeks followed by assessments every 4 weeks. Other safety evaluations including     EKGs, urinalysis, coagulation and thyroid function studies will be performed at regular     intervals.      Adverse event seriousness, severity grade, and relationship to study treatment will be     assessed by the investigator. Severity grade will be defined by the National Cancer Institute     (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.      Tumors will be assessed by contrast enhanced CT or MRI every 8 weeks. Pre-treatment tissue     will be obtained via CT-guided FNA biopsy or collected during resection. However, archival     tissue will also be requested, when available and if adequate for testing. Post-treatment     tissue will be obtained on Day 15 (i.e., Week 3/Day 1) via CT-guided FNA biopsy. All tumor     tissue from eligible patients will be utilized for the correlative studies which are outlined     in this trial.      Each subject's course will consist of three periods:        -  A Pre-Treatment Period in which subjects are consented and undergo screening assessments          to be qualified for the study;        -  A Treatment Period in which subjects receive study treatment and undergo study          assessments. Patients who meet the eligibility criteria will be treated with          cabozantinib orally at 40 mg daily and erlotinib orally at 100 mg daily without breaks;        -  A Post-Treatment Period in which subjects no longer receive study treatment but undergo          follow-up study assessments and contacts.   "
255352|NCT03211338|"     The aim of this study is to investigate the In Vitro and In Vivo effect of progesterone on     immature myeloid cells (IMC), inflammation characteristics and maturation into dendritic     cells (DC).   "
255357|NCT03210194|"     Background: About 10% of all newborns may have difficulty breathing and require support by     trained personnel. In Peru, 90% of deliveries occur in health facilities; however there is     not a national neonatal resuscitation and certification program for the public health sector.     In addition, the Andes and the Amazon regions concentrate large rural remote areas, which     further limit the implementation of training programs and the accomplishment of continuous     certification. Neonatal resuscitation training through the use of information, communication     and technology (ICT) tools running on a computer, tablet or mobile phone may overcome such     limitations. This strategy allows online and offline access to educational resources, paving     the way to more frequent and efficient training and certification processes.      Objective: To evaluate the effects of a neonatal resuscitation training and certification     program that uses a multi-platform ICT (MP-ICT) strategy on neonatal health care in remote     areas.      Methods: The investigators propose to conduct the study through a cluster-randomized trial,     where the study and analysis units are the health care facility. Eligible facilities will     include primary and secondary health care level facilities that are located in provinces with     neonatal mortality rates higher than 15 per 1,000 live births. The investigators will compare     the proportion of newborns with a heart rate ≥100 beats per minute at 2 minutes after birth     in health care facilities that receive MP-ICT training and certification implementation, with     those that receive conventional training and certification.      Discussion: The investigators expect that the intervention show to be more effective than the     current standard of care. The investigators are prepared to include it within a national     neonatal resuscitation training and certification program to be implemented at national scale     together with policymakers and other key stakeholders.   "
255359|NCT03205488|"     This study will assess the safety and tolerability of daily oral administration of nilotinib     (150-300mg once daily) in Parkinson's Disease.   "
255361|NCT03202667|"     Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of     antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water     retention and secondary natriuresis and is a common cause for hyponatremia.      Especially chronic (>72h) SIADH is difficult to treat as standard therapeutic options (water     restriction, urea, salt tablets) often do not succeed in correction of hyponatremia, making     additional therapy necessary.      Empagliflozin is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a     well-tolerated treatment option for type 2 diabetes mellitus. The inhibition of SGLT2 in the     proximal tubule leads to renal excretion of glucose with subsequent osmotic diuresis. This     mechanism could result in a therapeutic effect in patients with chronic SIADH, as it     resembles the aquaretic effect of urea.      The aim of this study is to evaluate whether empagliflozin has an effect on the serum sodium     levels of patients with chronic SIADH.   "
255545|NCT03028129|"     The purpose of this study is to determine if the isoniazid is effective in the prevention of     tuberculosis in a prison population, exposed to the high endemicity of the disease.   "
255362|NCT03263585|"     Background: Back pain and osteoporosis with vertebral fractures are common conditions in     elderly women and significantly affect their quality of life. A common complication of     osteoporosis are vertebral fractures. Treatment with bone-specific drugs does often not help     the pain condition caused by the vertebral fractures even when the progress of the disease     has decreased. Vertebral fractures often result in deformation of the spine and poorer     quality of life of the individual. The spinal kyphosis also affects the lung function and the     effect of the kyphosis itself is severe. Alternative treatments of back pain may lead to     reduced drug demand for pain. Physical activity is one of the most important factors that     regulates bone mass and can also affect balance and fall risk positively. The back orthosis     that we intend to use in the treatment study has been shown in some previous scientific     studies to strengthen the muscles in the back and also decrease the pain.      Purpose: The purpose of the study was to evaluate the effect of treatment of back pain in     elderly women with an activating functional orthosis versus treatment with a group of     physiotherapeutic tools and a control group for a six-month treatment period and follow-up     after 12 months from the start of study. The aim was also to study elderly women with     osteoporosis and back pain in a follow-up study of a cohort of women at high risk of     osteoporotic fractures, with focus on back pain, functional capacity and quality of life.      The aim was to study the effect of treatment with activating functional orthosis versus     physiotherapeutic treatment in a group and a control group without treatment. The main     outcomes will be the experienced perceived back pain and back extensor strength. Additional     outcomes will be quality of life, balance, lung function and kyphosis. Biochemical markers     for pain will be measured in the RCT (Randomized Controlled Trial).      Significance: Evaluation of alternative treatment methods such as exercise by a     physiotherapist and treatment with a functional orthosis will give new additional treatment     options for our patients. An activating functional orthosis could reduce the use of     analgesics and increase the quality of life of the affected women.   "
255363|NCT03264222|"     Patients with implantable cardiac electronic devices will be exposed to a new safety device     and evaluated for potential electromagnetic interference.   "
255366|NCT03204578|"     Investigator-initiated physiological study to characterize the function of a major drug     metabolizing enzyme using a microdosed phenotyping probe to avoid unwanted,     concentration-dependent effects.   "
255368|NCT03214211|"     To observe the effiacay, safety and risk of developing diabetes, review the patients chars     who had administrated or neet to administrate the Pravafenix cap for enroll period, it is an     prospective observational study that only collect the collectable information follwoing the     hospital visiting date from enroll point to information collecting date. There is no extra     visit for this study.      Observe the data which has been collected for 3 yearts every year from enroll point, if the     patients agree to be participated in this study and are suitable in inclusion/exclusion     criteria.      If the lipid-lowering drugs(only Ezetimibe is possible) is add-on the Pravafenix Cap     administrating period, it will be analyzed by laering analysis separately. But, the reason     why it is add-on to have to be written on e-CRF.   "
255438|NCT03123250|"     Single-arm, interventional pivotal clinical trial collecting patient data from use of the     AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a     high-velocity saline stream to resect and remove prostate tissue in males suffering from     Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).The primary     endpoints for safety and effectiveness will be measured at 3 months post-treatment. All     treated subjects will be followed out to 12 months to collect long-term clinical data.   "
255559|NCT02971319|"     This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared     to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to     obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an     intra-individual comparison.   "
255369|NCT03196609|"     In order to understand how the intestinal microbiota plays a role in the effectiveness of an     anti-cancer treatment by an immune control point inhibitor, this study aims to constitute a     catalog of microbial genes of a patient with cancer. This catalog will help to characterize     the intestinal microbiota of cancer patients and to be able to use this catalog as a     reference tool for screening the microbiota of patients treated with immune control point     inhibitors. To produce this catalog, five types of cancer were selected: non-small cell lung     cancer, colorectal cancer, hepatocellular carcinoma, breast cancer and prostate cancer.      The metagenomic analysis of a group of five different types of cancers introduces a lot of     heterogeneity which is favorable to the richness of a catalog. For non-small cell lung cancer     treated with immune control point inhibitors, two stool collections will be performed per     patient (one stool collection before setting up an immune control point inhibitor and one     collection after one month of being inhibited Of immune control point) to assess the impact     of the immune control point inhibitor on the microbiota (pilot study). For this study, two     stool collection tubes containing different preservative solutions will be used (one RNAlater     tube and one DMSO-EDTA tube for Dimethylsulfoxide-Ethylene diamine tetraacetic acid).      In parallel, we will also collect samples of serum and plasma to evaluate, in a second step,     protein markers in circulating blood.   "
255371|NCT03269383|"     Atrial fibrillation requires both an initiation trigger and favorable environment for     maintenance and the sympathetic and parasympathetic nervous systems play important roles in     this regard. Unfortunately, the precise mechanisms of post operative atrial fibrillation     (POAF) are still being investigated. This postoperative complication has persisted in spite     of efforts to mitigate it pharmacologically with beta blockers and amiodarone, an experience     shared by most other cardiac surgery centers.      The stellate ganglion is formed by the fusion of the inferior cervical sympathetic ganglion     and first thoracic sympathetic ganglion. By modulating the sympathetic component of the     autonomic nervous system, stellate ganglion stimulation has been shown to facilitate     induction of atrial fibrillation while ablation may reduce or prevent episodes. Human studies     have further supported this model.      Preliminary studies of perioperative stellate ganglion block (SGB) in cardiac surgery suggest     that this technique may reduce or prevent episodes of POAF requiring treatment. The     investigator's hypothesis is that SGB reduces the incidence of POAF in cardiac surgery     populations.   "
255372|NCT03270826|"     Introduction: new methods of evaluation of respiratory function, such as electrical impedance     tomography (EIT) and optoelectronic plethysmography (OEP), have been used to measure regional     pulmonary ventilation and the variation of tricompartmental volumes of the thoracic cavity,     respectively. Analysis of these instruments during maximal respiratory maneuvers associated     with respiratory pause with monitoring of esophageal pressure may probably provide additional     information on the physiological behavior of the cardiorespiratory system in spontaneous     breathing during EIT and OEP maneuvers. Objectives: To describe the physiological behavior of     maximal respiratory maneuvers through the electrical impedance tomography and optoelectronic     plethysmography in healthy men.      METHODS: This is a cross-sectional study involving 10 healthy male volunteers. The     development of the method will take place in 3 stages. The first step corresponds to the     characterization of the inspiratory and expiratory curves in the respiratory cycle generated     by the impedance variation (ΔZ), the mobility of the chest wall and the pulmonary volume     curve during maximal respiratory maneuvers. 2nd stage: verification of the correlation     between the variables extracted from EIT, OEP and pneumotachograph (PNT). Step 3: Estimate     the dislocated blood volume of the lung through previous analyzes.   "
255374|NCT03264924|"     Cardiac rehabilitation is a programme of exercise and health advice for people recovering     from heart disease. Pulmonary rehabilitation is a similar programme for people with chronic     lung disease. For both groups of patients, taking part in rehabilitation can lead to     improvements in health and well-being. However, only 30% of patients complete their agreed     rehabilitation programme. This costs the NHS millions of pounds every year. This project aims     to investigate whether a motivational-based intervention, underpinned by self-determination     theory and motivational interviewing, will enable staff to encourage more patients to take     part in physical activity (PA). Staff will be trained with the new communication skills and     will then deliver the rehabilitation programme. The session content will not change, just the     way in which staff speak to patients.      This will be a two-phase study. Phase A will take a qualitative approach collect patient and     staff feedback about the current rehabilitation programme, before using this information to     develop and pilot the intervention. Phase B will then assess the feasibility of the     intervention within cardiac and pulmonary rehabilitation. Participants agreeing to take part     in the phase B will be required to complete an interview and questionnaire at three time     points. Patients' personal opinions of the programmes will be extremely important in     discovering what can be done to improve rehabilitation for future participants.      The main objectives will be to look at whether the intervention increases the number of     patients taking part in physical activity. The investigators plan to establish how much     physical activity patients take part in whilst they are in rehabilitation, as well as once     they have left the programme. This is why participants will be interviewed three and six     months after they have finished their rehabilitation programme.   "
255378|NCT03190369|"     Primary Objective:      -To evaluate the efficacy of a single 6-mL intra-articular (IA) injection of Hylan G-F 20     measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numerical     Rating Scale (NRS) 3.1 A1 score over a total period of 26 weeks in Chinese patients with     symptomatic osteoarthritis (OA) of the knee.      Secondary Objectives:        -  To evaluate the response rate of a single 6-mL IA injection of Hylan G-F 20 in          comparison to an IA placebo injection over 26 weeks. Response is defined as WOMAC A1 ≥2          point improvement from baseline on NRS in daily pain score averaged over a 7-day period.        -  To evaluate the safety of a single 6-mL IA injection of Hylan G-F 20, in comparison to          an IA placebo injection over 26 weeks.   "
255383|NCT03191734|"     Single arm, multi-center prospective clinical trial to determine the safety and effectiveness     of the AQUABEAM System in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80     years of age.   "
255388|NCT03243097|"     Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear     Implants. The majority of bilaterally deafened patients, however, often only receive a     unilateral cochlear implant (CI), with resultant limitations related to monaural listening.     For unilateral CI users, the deficits inherently associated with monaural listening remain     despite the considerable benefits achieved through implantation. Providing bilateral input to     monaural listeners (MLs) overcomes some of these disadvantages. Treatment by contralateral     routing of signal (CROS) hearing aids, where the signal of interest is routed from the     impaired (deaf) ear to the normal cochlea for processing is a promising alternative in     unilateral CI recipients who cannot benefit from bilateral CIs. Utilizing CROS technology     provides a less invasive alternative for patients who are unable or unwilling to undergo a     second CI surgery and offers an innovative approach to resolving the auditory deficits     associated with monaural listening. CROS technology has been used to treat traditional     monaural listeners since 1965. When applied to unilateral CI users, this novel approach can     overcome a key limitation of current treatment by restoring access to sound from the     non-implanted ear and improving speech perception in noise.   "
255390|NCT03183856|"     The aim of this study is to determine the clinical efficacy and feasability of gait     rehabilitation robot through approving functional improvement by an end-effector typed gait     robot in patients underwent total knee arthroplasty.   "
255392|NCT03269344|"     Strategies to minimize and mitigate external beam radiation therapy related mucositis and     pain during the treatment of head and neck cancer remain limited. The investigators     hypothesize that gabapentin could be used to delay or reduce treatment-related pain, reliance     on opioid medication, and improve the quality of life for these patients.   "
255393|NCT03179462|"     The investigators will examine the effects of a given amount of a protein food source such as     pork, mixed nuts, and tofu on anabolic response at the whole body and muscle levels in young,     healthy adults.   "
255395|NCT03174795|"     This is a non-randomized, open-label, one-treatment, one group study in participants with     complicated urinary tract infection (cUTI) including pyelonephritis to characterize the     pharmacokinetics of RO7079901 co-administered with meropenem.   "
255396|NCT03176628|"     This study will determine the pharmacokinetics, pharmacodynamics and safety of escalating     doses of Basis following twice daily oral administration in patients with acute kidney injury     (AKI). Basis is a commercially available nutritional supplement consisting of nicotinamide     riboside (NR) and pterostilbene that acts to increase sirtuin activity.   "
255397|NCT03172208|"     Primary objective:      To assess the safety and tolerability of single ascending intravenous (i.v.) doses, a single     subcutaneous (s.c.) dose of caplacizumab (Part I), and multiple s.c. doses of caplacizumab     (Part II) in Japanese subjects.      Secondary objectives:        -  To compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles (total vWF:Ag          concentration levels [vWF:Ag], coagulation factor VIII [FVIII:C], and ristocetin          cofactor activity [RICO]) after single i.v. or s.c. administration of caplacizumab in          Japanese and White subjects.        -  To evaluate the immunogenicity of caplacizumab (anti-drug antibodies [ADA]) in Japanese          subjects.   "
255398|NCT03171311|"     The purpose is to compare median two-year clinical outcome after OCT guided vs. standard     guided revascularization of patients requiring complex bifurcation stent implantation   "
255482|NCT03270800|"     A Phase 1, multi-center, randomised, double-blind and adjuvant-controlled study to evaluate     the safety, tolerability, and efficacy of IMX101 in H. pylori-negative and H. pylori-infected     healthy volunteers.      The study will be conducted in 2 phases. Phase A: Study design contains 6 cohorts, each     containing 8 subjects. Three cohorts (24 subjects) will be H. pylori-negative and 3 cohorts     will be H. pylori-infected. Subjects fulfilling the inclusion criteria will be assigned to     one of 3 sequential dose cohorts with a 3:1 randomisation to IMX101 or to CTA within each     cohort.      Phase B: Two cohorts with H. pylori-infected subjects can be expanded up to 20 subjects in     each cohort. The decision whether to expand the cohorts will be taken by the Sponsor and the     DSMB, as soon as the results of the safety and efficacy analyses are available.      Up to 72 subjects collectively in Phases A & B will be recruited. depending on immunogenicity     status.   "
255404|NCT03171818|"     The aim of the study is to perform a randomized double-blind placebo controlled prospective     study in newborn infants with MRI confirmed Middle Cerebral Artery (MCA) Perinatal Arterial     Ischemic Stroke (PAIS) with darbepoetin. It will be investigated whether intravenous     administered darbepoetin can induce the formation of neuronal tissue and restore brain     function in neonates who suffered from PAIS compared to placebo treated controls. The     ultimate goal of this study is therefore to develop a therapy using     erythropoiesis-stimulating agents (ESA) such as darbepoetin to reduce or even prevent     lifelong consequences of PAIS-related brain injury in this group of term newborns.   "
255483|NCT03068689|"     Remote Ischaemic PreConditioning (RIPC) is performed prior to partial nephrectomy.     Postoperative calprotectin dynamics and Blood Oxygen-Level-Dependent (BOLD) MRI are used to     to demonstrate the potential renoprotective effect of RIPC   "
255573|NCT03157635|"     This is a Phase I/II, first-in-human study consisting of 3 sequential parts in which the     safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single-doses of     RO7112689 will be evaluated in healthy volunteers (HV) during Part I, and safety,     tolerability, PK, PD, and efficacy of multiple-doses of RO7112689 will be evaluated in     participants with paroxysmal nocturnal hemoglobinuria (PNH) during Parts 2 and 3 of the     study.   "
255407|NCT03165201|"     This will be a prospective, multi-centre, biomarker trial comparing the accuracy of a new     test (LiverMultiScan) against an existing test (liver biopsy) in the assessment of liver     transplant recipients, designed in accordance with the STARD criteria.      Study participants are 200 patients with liver transplant, due to undergo liver biopsy as     part of serial evaluation of their liver health and to rule out rejection. The whole study     will take 3 years with 2 years of recruitment The main aim is to investigate whether the     introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match     the diagnostic yield of existing biopsies.   "
255532|NCT03010176|"     The purpose of this study is to identify a maximum tolerated dose (MTD) or maximum     administered dose (MAD) of MK-1454 alone or MK-1454 in combination with pembrolizumab     (MK-3475) in participants with advanced/metastatic solid tumors or lymphomas. MK-1454 will be     administered intratumorally (IT); pembrolizumab will be administered intravenously (IV).   "
255408|NCT03175796|"     The primary objective is to rigorously evaluate the effectiveness of the Infant Mental Health     Home Visiting (IMH-HV) model on maternal and child outcomes according to legislative     standards via a randomized controlled trial. The research team will recruit caregivers and     their children (0-24 months) or pregnant women (n=72) from locations across Washtenaw County     to participate in the IMH-HV RCT. Half of the women will be randomly assigned to a treatment     as usual (TAU) control group (with access to all available community resources), and half of     the women will be randomly assigned to the treatment group (i.e., IMH-HV). Women assigned to     the control group will not receive IMH-HV treatment through the study team, but will not be     prohibited from seeking or accessing IMH-HV treatment or any other services through community     resources. Women assigned to the treatment group will receive IMH-HV treatment for 12 months     through the study team with rigorous monitoring of fidelity to the IMH-HV model. All study     participants will undergo assessments across the 12-month period of the treatment trial     (i.e., baseline (randomization will occur after baseline), mid-points (3, 6 and 9 months) and     follow-up (12 months) after randomization).      The purpose of this study is to evaluate efficacy of the Infant Mental Health Home-Visiting     (IMH-HV) model on parental and child outcomes according to legislative standards and     consistent with the State of Michigan's benchmarks. If this study confirms the efficacy of     the IMH-HV model, this will support the sustainability of IMH-HV in the state of Michigan as     evidence from a randomized controlled trial is necessary in order to access certain state and     federal dollars. Access to evidence-based and sustainable parenting support can ultimately     improve outcomes for this vulnerable population. Specifically this study aims to:        1. Conduct a randomized controlled trial to evaluate the efficacy of IMH-HV treatment          utilizing rigorous outcomes monitoring and evaluation methodology to establish that the          families served achieve the intended positive benefit. Eligible caregivers and children          or pregnant women will be assigned to the control group or the treatment group and both          groups will receive research assessments at regular intervals measuring key impacts of          the IMH-HV model.        2. Determine IMH-HV efficacy via analysis of treatment impact on key caregiver, child, and          family indicators. The hypothesis is that there will be positive impacts of IMH-HV, with          caregiver, child, and family-level improvements from baseline to post assessment on key          indicators, including:             1. Improved child outcomes as reflected in strengthened child physical and behavioral               health, development and school readiness, and reduced risk for child maltreatment.             2. Improved parental outcomes including improved parent mental health, decreased child               abuse potential, and enhanced positive parenting.             3. Improved family environment including decrease in crime and family violence,               enhance linkage to referrals and improve family economics and self-sufficiency.        3. Identify factors associated with family improvement, including dosage and fidelity of          treatment. It is the hypothesis that a dose-response association between the number of          home visiting sessions and treatment impact, and a positive association between fidelity          of treatment delivered and positive child and family outcomes.   "
255409|NCT03158857|"     Hepatitis C is an important health problem in Myanmar affecting around 3% of the population.     New drugs have been developed which have transformed the treatment of this disease around the     world with very high success rates. Two of these drugs are now registered for use in Myanmar.     In this study 200 patients with chronic hepatitis C(100 with HIV co-infection) will be     assessed and started on the new treatment. We will observe them and measure treatment     effectiveness and tolerability. In 24 patients extra blood samples will be taken for drug     measurements to describe the effect of the drugs on patients in Myanmar in more detail.   "
255410|NCT03163446|"     The purpose of this study is to evaluate the safety, tolerability, efficacy and     pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC)     antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream     infections (bacteremia), including right-sided endocarditis in adults. Patients will be     randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC     antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by     the investigators based on their professional experience, practice guidelines and local     antibiotic susceptibility information for the treatment of S. aureus bacteremia.      CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has     demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone     and in addition to conventional antibiotics.   "
255413|NCT03153462|"     This is a multicenter, open-label expanded access protocol for the treatment of subjects with     relapsed/refractory transplant ineligible aggressive NHL.   "
255416|NCT03151304|"     This is a Phase 2, two-stage study of the safety and efficacy of pracinostat in combination     with azacitidine in patients with IPSS-R high and very high risk MDS who are previously     untreated with HMAs. Enrollment in this study will be limited to high/very high risk MDS     because this group represents the highest unmet need, with median survival of less than 18     months.      Stage 1 will be conducted as an open-label single arm in up to 40 subjects to assess if this     regimen with a lower pracinostat dose results in a discontinuation rate that meets a     predefined threshold and in efficacy that justifies expansion of enrollment into Stage 2.      A discontinuation rate of approximately ≤10% in Stage 1, a rate comparable to that observed     with azacitidine alone in study MEI-003, is considered desirable and supports expansion into     Stage 2.      Stage 2 will be conducted as a randomized, double-blind, placebo-controlled, two-arm design     to confirm that the discontinuation rate observed in an open-label design can be reproduced     in a placebo controlled design, and to provide unbiased information on efficacy and safety.     Subjects will be randomized in a 1:1 ratio to one of the 2 treatment arms (Arm A, pracinostat     + azacitidine and Arm B, placebo + azacitidine). Study drugs should be continued until     disease progression or intolerable toxicity. It is important to note that the median time to     achieving a response with azacitidine alone is 4 to 5 months. Furthermore, the median time to     achieving a CR in study MEI-003 was 4 cycles. Therefore, early (<6 months) discontinuation of     trial therapy for 'no response' should be avoided. The Medical Monitor should be contacted     prior to discontinuing a subject from the study to discuss the rationale for discontinuation.   "
255419|NCT03143998|"     This is a non-randomized, open-label study of a fixed dose combination (FDC) of elbasvir (50     mg) and grazoprevir (100 mg) (EBR/GZR or MK-5172A) in participants with chronic hepatitis C     virus (HCV) genotype 1 (GT1) infection with advanced fibrosis with and without human     immunodeficiency virus (HIV) co-infection. All participants will be either HCV treatment     naïve (TN) or treatment experienced (TE).   "
255422|NCT03161158|"     This study evaluates whether tailored, peripheral ultrafiltration complementary to low-dose     diuretics is associated with a reduction in cardiovascular mortality in 90 days after     randomization and heart failure events in 90 days after discharge than usual care including     stepped intravenous diuretics in acutely decompensated chronic heart failure with fluid     overload (not fully responsive to diuretic therapy).   "
255423|NCT03151720|"     The purpose of this study is to establish the relative bioavailability of Xisimin     (loratadine) compared to Clarityne in healthy participants receiving a single dose of 10     milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of     Cohort 2.   "
255427|NCT03135171|"     The goal in this Phase 1 dose-escalation trial of the anti-IL-6R monoclonal antibody     tocilizumab in combination with trastuzumab and pertuzumab in subjects with metastatic HER2     positive breast cancer is to determine the safety, tolerability and recommended Phase 2 dose     of tocilizumab given with trastuzumab and pertuzumab every 3 weeks.   "
255624|NCT02877355|"     This trial is conducted in Europe. The aim of this trial is, to investigate the effect of     upper gastrointestinal disease on the pharmacokinetics (the exposure of the trial drug in the     body) of oral semaglutide in subjects with type 2 diabetes.   "
255428|NCT03131635|"     This is a research study examining the effectiveness of a Developmental Reciprocity Treatment     Program (DRT-P) in treating social deficits in children with Autism Spectrum Disorders (ASD).     Developmental Reciprocity Treatment is an early intervention that applies     developmentally-informed teaching methods in naturalistic settings in order to target social     and communication deficits.      Researchers have begun to develop strategies to investigate the effectiveness of combining a     parent training program teaching parents how to implement DRP with in-home,     therapist-implemented treatment. To determine the effectiveness of the DRT-P, it will be     compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week     trial. This research will allow us to help in the development of therapeutic approaches that     can meet the increasing service demands for families. We hope that investigating     interventions that aim to improve core deficits will aid in providing better care for     children with autism.   "
255431|NCT03143621|"     Post-operative ileus (post-op ileus) is a condition which can occur after surgery. This     means that the bowels stop working correctly and food and liquids will not pass through in     the normal manner. Post-op ileus can be uncomfortable and require a longer hospital stay     until the bowels begin to function correctly again. Currently there are no effective methods     for preventing post-op ileus. Some studies suggest there is a benefit from drinking coffee     following colon or gynecological cancer surgeries with very little risk. However, the effects     of coffee following small bowel surgery have not been studied. This randomized, controlled     trial will compare the outcomes of patients who receive coffee during their hospital stay     after small bowel surgery to similar patients who receive warm water. About 60 patients will     be in each group. The main outcomes are time until the nasogastric tube is removed and length     of hospital stay.   "
255435|NCT03127514|"     The CENTAUR trial will be a 2:1 (active:placebo) randomized, double-blind, placebo-controlled     Phase II trial to evaluate the safety and efficacy of AMX0035 for the treatment of ALS.   "
255442|NCT03132246|"     A prospective trial conducted at Shock Trauma of patients between 18 years of age and older     who have sustained a fracture with metal implanted. The investigators will be collecting     between 1-3 routine blood draws for the purpose of laboratory analysis to assess biofilm     growth. Patients may be infected or non-infected at the time of blood draw; they will be     selected at random for purposes of this study. All patients will be followed as standard of     care by their treating physician for all their follow up visits.   "
255444|NCT03108612|"     The aim of the study is to evaluate the diagnostic accuracy of an instrument (semi-structured     interview) called Workload Analysis Instrument (WAI) (Análisis de Carga de Trabajo ACT), in     detecting the presence of occupational risk in patients presenting an upper-limb     musculoskeletal disorder. The test instrument was developed by Asociación Chilena de     Seguridad (ACHS). This instrument will be applied to the worker when he or she visits the     ACHS health care facility. The test administration is performed by an ergonomics specialist     previously trained in WAI. WAI is the index test and the gold standard will be the Estudio de     Puesto de Trabajo (EPT) resolution. The hypothesis of the study is that WAI is able to     correctly label the occupational origin (rule in or rule out) of an upper-limb     musculoskeletal disorder. Sensitivity, specificity and positive predictive value will be     established.   "
255447|NCT03103542|"     The primary purpose of this study is to describe the outcome of Immune Tolerance Induction     (ITI) treatment performed with rFVIIIFc within a timeframe of 60 weeks in patients with     haemophilia A who have failed previous attempts at tolerization.   "
255450|NCT03109886|"     The primary aim of this exploratory study is to test the safety and tolerability of milciclib     when administered orally at 100 mg in patients with recurrent or metastatic Hepatocellular     Carcinoma. The evaluation of the efficacy profile is a secondary objective of the study.     Moreover, markers expression in tumor cells and plasma will be studied and described in     association with the clinical outcome.      Eligible patients will receive milciclib orally on a daily schedule for 4 consecutive days a     week in a 4-week cycle (4 days on/3 days off x q4 wks) for a total of 12 weeks (i.e. 3     cycles) unless patient refusal, consent withdrawal, Investigator's decision, unacceptable     toxicity or death whichever occurs earlier.      At the end of Cycle 3, treatment will be stopped, and based on the results of the tumor     assessment performed on Day 90 (±3 days) from treatment start, patients will be followed as     here below detailed:        -  patients with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) will be          followed for safety until 30 days from last dose intake (or until a new anticancer          therapy starts, whichever occurs earlier) and will be assessed for efficacy in the          follow-up period up to Day 180 from treatment start;        -  patients with progressive disease will be followed only for safety until 30 days from          last dose intake (or until a new anticancer therapy starts, whichever occurs earlier).      After the completion of three cycles, patients who, in the Investigator's judgment, are     benefiting from treatment with milciclib, will resume treatment and will remain on study up     to Day 180 from treatment start, unless withdrawal criteria are met earlier.   "
255451|NCT03100149|"     This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate     the efficacy of intravenous RO7046015 versus placebo over 52 weeks in participants with early     Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B)     inhibitors since baseline. The study will consist of 2 parts: a 52-week, double-blind,     placebo-controlled treatment period (Part 1) after which eligible participants will continue     into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part     2).   "
255473|NCT03081325|"     Recurrent spontaneous abortion(RSA) and repeated implantation failure (RIF) during IVF-ET     severely affects IVF live birth rate and patient's health.The specific etiology contains     chromosomal abnormalities, reproductive anatomical abnormalities, endocrine disorders,     reproductive system infections, autoimmune and environmental factors. However there are still     50% to 60% RSA which don't have a clear cause, called unexplained recurrent spontaneous     abortion (URSA), mainly related to immune factors.Among various treatments,lymphocytes active     immunotherapy is the most common treatment method, and its clinical efficacy is widely     recognized although its action mechanism is not clear so far.   "
255625|NCT02890602|"     This is a phase Ⅱ study of erythropoietin for management of anemia caused by chemotherapy in     patients with Diffuse Large B-cell Lymphoma. The investigators want to investigate     hematopoietic response of darbepoietin alfa and the quality of life assessment of     increasement of hemoglobin.   "
255456|NCT03269006|"     Visceral leishmaniasis (VL) also known as kala-azar is a public health problem in Bangladesh.     Since 2005 a national kala-azar elimination program is going on in the country. The program     has preparatory, attack, consolidation and maintenance phases. The target of the program is     to reduce the VL incidence less than 1 per 10,000 people at upazila (sub-district) level in     VL endemic upazilas of the country. The program is heading successfully to its consolidation     phase.      During attack phase house to house search for VL suspects and also suspects with     Post-kala-azar Dermal Leishmaniasis (PKDL) was the tool for early diagnosis of VL and PKDL     cases. Indoor residual spraying with insecticide (Deltamethrin) was the method for sand fly     control to reduce the transmission of the disease. Since in the consolidation phase the VL     case load is many times less than that in the attack phase, house to house search for VL and     PKDL cases and IRS for vector control is no more cost-effective for the program. Therefore     there is a need for alternative methods for active search of VL and PKDL cases and method for     sand fly control, appropriate for the consolidation phase.      In the present study we propose to investigate the efficacy of Inesfly 5AIGRNG TM containing     Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial available     durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB     123, indoor residual spraying (IRS) with Delthamethrin against a control group Methods: A     cluster randomized controlled design to measure sand fly density reduction at intervention     household as well as sand fly mortality by entomological methods.      Outcome measures/variables: reduction of sand fly density at intervention household and sand     fly corrected mortality on intervention surfaces compare to control households/conditions.   "
255460|NCT03103243|"     The study tests whether contemplative-based intervention can modify pathogenic processes in     participants with Lupus. Techniques such as meditation, mindfulness and yoga may have an     impact on the disease and may decrease psychological distress, increase self-regulation     capabilities, and reduce pain. Additionally, incorporating patients' caregivers may     strengthen their relationships and, thereby, improve their health and well-being.   "
255469|NCT03094052|"     This is a study to evaluate the toxicity profile of neratinib in combination with trastuzumab     in patients with early stage breast cancer with the use of anti-diarrheal prophylaxis. The     anti-diarrheal medications being tested in this trial are loperamide and crofelemer.     Crofelemer is an anti-diarrheal, enteric-coated drug product for oral administration. It is     the only botanical drug currently approved by the FDA for oral administration and is approved     for the treatment of diarrhea associated with HAART. Crofelemer has a novel mechanism of     action, acting directly and simultaneously on 2 distinct intestinal luminal chloride     channels. It is an inhibitor of both the cyclic adenosine monophosphate (cAMP)-stimulated     cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl-) channel found     on the apical membranes, and the calcium-activated Cl- channels (CaCC) at the luminal     membrane of enterocytes. The CFTR Cl-channel and CaCC regulate Cl and fluid secretion by     intestinal epithelial cells. Crofelemer acts by blocking Cl- secretion and accompanying high     volume water loss in diarrhea, normalizing the flow of Cl- and water in the GI tract.   "
255463|NCT03134092|"     To compare the effectiveness of 3 strategies to inform patients of their risks associated     with misuse of opioid prescriptions after treatment in the ED from renal colic or     musculoskeletal back pain. Randomization will be to 3 arms for the Randomized Practical     Control Trial across 3 sites (A) standardized general risk information sheet only (B)     standardized general risk information sheet plus a visual probabilistic risk tool (C)     standardized sheet plus narrative enhanced probabilistic risk tool.   "
255464|NCT03089190|"     A double-blind, randomized crossover design with four arms including three experimental     conditions and placebo will be applied. After having successfully completed screening     procedures, eligible participants will be invited to four separate test days. The test days     are separated with at least 7 days, however 4 days can be accepted for logistical reasons.     During the entire course of the study, participants must remain weight stable and not change     their diet or physical activity level. Significant changes in diet, physical activity level     (evaluated by the sub-investigator) or weight change ±3 kg over the course of the study (from     screening to completion of the last test day) results in exclusion of that subject.   "
255465|NCT03085173|"     The purpose of this phase I study is to test the safety of different dose levels of specially     prepared cells collected from the patient called modified T cells. The investigators want     to find a safe dose of modified T cells for patients with this type of cancer that has     progressed after standard therapy. The investigators also want to find out what effects these     modified T cells have on the patient and the cancer.   "
255467|NCT03101917|"     The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear     Implantation consists of a patient-customized microstereotactic frame which targets the     cochlea. The intended use of the device in this early feasibility study is to surgically     access the cochlea, allowing placement of an intra-cochlear electrode array for cochlear     implantation, thereby providing a less invasive surgical option than currently performed.     Compared to traditional cochlear implantation (CI) surgery, the investigators hypothesize     that the minimally invasive, image-guided approach may offer the following benefits: (1)     shorter procedure time including shorter general anesthesia time, (2) less tissue removal     potentially eliminating post-operative mastoid bone depression, decreased post-operative     patient discomfort, and quicker wound healing, (3) better chance of preservation of taste     secondary to preservation of the chorda tympani nerve, and (4) standardization of electrode     placement potentially allowing more consistent placement within the scala tympani     sub-compartment of the cochlea which has been shown to be associated with improved     post-operative audiological performance. This early feasibility study will focus on the     advantages of the new technology to the patient. Advantages to the healthcare delivery system     will be examined during the pivotal study phase.   "
255468|NCT03136484|"     This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the     trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0     mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects     with type 2 diabetes (T2D) on a background treatment of metformin   "
255471|NCT03078478|"     The trial is conducted in Europe, North America The aim of the trial is to compare the     efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with     type 2 diabetes mellitus inadequately treated with basal insulin with or without oral     antidiabetic drugs.   "
255590|NCT02927769|"     The purpose of this study is to determine whether nivolumab + brentuximab vedotin, followed     by brentuximab vedotin + bendamustine for participants with a suboptimal response, is safe     and effective in the treatment of classic Hodgkin lymphoma (cHL) in children, adolescents,     and young adults after failure of first line therapy.   "
255497|NCT03051607|"     Phase 3, international, multicenter, open-label 12 month safety study.   "
255477|NCT03077698|"     This is an open-label, multi-center, single-arm, two-period Phase 2 study. The study will     investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a     population of subjects with endometrial cancer, who have failed progestin monotherapy or who     have been identified as PrR negative. All patients must have endometrial cancer PrR status     determined from an archival sample at Screening. The PrR status (positive or negative) will     be determined by central laboratory by IHC testing.      There are two treatment periods and a follow-up period within the study.   "
255478|NCT03070470|"     This study will assess whether exposure response analysis of the electrocardiographic QTc and     J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs     that predominantly block the potassium channel encoded by the human ether-à-go-go-related     gene (hERG) with approximately equipotent late sodium and/or calcium block (balanced ion     channel drugs) do not cause J-Tpeakc prolongation and that drugs that predominantly block     hERG without late sodium or L-type calcium current block (predominant hERG drugs) cause QTc     prolongation.   "
255479|NCT03078751|"     This is an international, multi-center, randomized, double-blinded, placebo-controlled     clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an     adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk     breast cancer.   "
255481|NCT03072056|"     -  To evaluate the pharmacokinetic (PK) profile of MIN-101 and its metabolites in extensive          (EM) and poor (PM) metabolizers        -  To evaluate the relationship between plasma levels of MIN-101 and changes in QT/QTcF          intervals        -  To evaluate safety and tolerability of MIN-101.   "
255484|NCT03063515|"     The investigator will examine the effect of a single dose of pyridostigmine, AchE inhibitor     on insulin secretion in healthy subjects. Each subject will undergo an intravenous glucose     tolerance test (IVGTT) where IV glucose will be administered and the glucose excursion and     insulin secretion response will be evaluated by measuring insulin and glucose at different     time points. The test will be carried out twice, once without and once with the     administration of a single dose of Pyridostigmine on two separate days. The investigator     hypothesizes that inhibiting AChE will potentiate insulin secretion.   "
255486|NCT03068858|"     The SYNTAX score (SS) has been recommended by clinical guideline and appropriate use criteria     for coronary revascularization (CR) to provide guidance on optimal treatment strategies for     patients with stable coronary artery diseases (CAD). However, discrepancy in SS between     angiographic core lab (ACL) and cardiologists has been found. Whether the misestimate will     lead to inappropriate CR and whether a SS intervention will improve CR appropriateness in     patients with stable CAD remain unknown.      Thus, our study aims at evaluating whether a real-time feedback from ACL rightafter the     angiographies will improve CR appropriateness. A before-and-after controlled trial was     designed. In the first period of time, stable CAD patients undergoing elective coronary     angiographies with at least one coronary lesion stenosis ≥ 50% from one Chinese cardiac     center will be continuously recruited as the control group. In the second period, eligible     patients will be recruited continuously and a real-time SS category feedback from ACL     rightafter the angiography will be given to the cardiologists. Appropriateness of treatment     strategies in two groups will be analyzed to determine whether a real-time SS feedback can     improve the treatment appropriateness. The appropriateness of treatment strategies will be     adjudicated by Chinese version appropriate use criteria for CR.   "
255487|NCT03061214|"     This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to     compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin     100 mg once-daily on glycaemic control after 30 weeks of treatment. Subjects will remain on     their stable pre-trial metformin.   "
255492|NCT03057678|"     Otologic surgery often involves a mastoidectomy to safely access the inner ear. In this     procedure, a portion of the mastoid part of the temporal bone is removed. The surgery is     lengthy and challenging because many critical structures are embedded in the mastoid and are     difficult to identify and accurately remove with a surgical drill. In previous work, the     investigators developed a compact, bone-attached robot to automate mastoidectomy drilling for     translabyrinthine acoustic neuroma removal (TANR). The robot does not attach directly to the     bone. Instead, a rigid surgical fixture which the investigators call a prepositioning frame     (PPF) is attached to the temporal bone, and the robot attaches to the PPF. Attaching the     robot to the participant eliminates the need for an expensive image guidance system to     compensate for participant motion, but requires a compact robot with a limited range of     motion. The PPF supports the robot on the head such that a planned mastoidectomy volume is     within the robot's range of motion. In this study, the investigators plan to test the PPF by     attaching it to ten participants. By processing an intraoperative CT scan of the attached     PPF, the investigators will measure the percentage of each planned mastoidectomy that would     be reachable if the robot were attached. The investigators will also measure the time     required to attach the PPF. The data the investigators acquire will enable further     improvements to the PPF design, which would be advantageous before proceeding to robotic     drilling experiments.   "
255494|NCT03056040|"     The purpose of this study is to assess ALXN1210 compared to eculizumab in adult patients with     PNH who are clinically stable on eculizumab for at least 6 months   "
255495|NCT03073590|"     The current study is aimed at evaluating nutrition interventions to be implemented for     improving health and nutritional status of female garments workers in 4 selected garment     factories in Bangladesh. The interventions will attempt to increase either energy intake and     or iron intake by female garments workers and expected to implement the interventions as     planned:        1. Provision of a once weekly iron/folate supplement, and nutritionally improved, daily hot          lunch including multi-nutrient fortified rice plus a nutrition and health behavior          change communications (BCC) program in intervention factory compared with a control          factory which will provide regular lunch meal plus a nutrition and health behavior          change communications (BCC) program for 10 months        2. Provision of a twice weekly iron/folate supplement plus a nutrition and health BCC          program in an intervention factory compared with a control factory with only nutrition          and health BCC program for 10 months; on the following outcomes:             -  Prevalence of anemia             -  Nutrition knowledge and practices as per key messages of the BCC program             -  Worker satisfaction with the modified lunch and/or iron/folate supplementation, and               the BCC program   "
255502|NCT03062761|"     It is universally accepted that the best nutrition for a new-born infant is breast milk.     Breast milk provides a complete set of nutrients to support growth and development of     children in early life, including components that have a beneficial effect on gut health and     the body's ability to defend itself against infectious organisms and other invaders (immune     system).However, it may occur that a mother is unable to breastfeed her child, or chooses not     to breastfeed. In such cases, an infant formula inspired by breast milk is the best     alternative. Research is done to optimize milk formula for infants. One of these formulas     contains 'partially hydrolyzed' proteins instead of intact proteins, meaning the proteins in     this formula are broken down into smaller pieces. These smaller pieces of protein make the     milk more suitable for consumption by infants at risk of developing cow's milk allergy. These     types of partially hydrolyzed protein formulas have been on the market for several years, in     particular for children with a family risk of allergy. So far, no safety related issues have     been reported. It is also known that weight gain of infants receiving partially hydrolyzed     proteins in general is appropriate according to the World Health Organisation growth     standards.      The main purpose of the TENUTO study is to demonstrate that infants who receive a specific     partially hydrolyzed protein infant formula for the first 4 months of life have a similar     weight gain compared to infants receiving standard infant formula with intact proteins. A     group of infants who receive breast milk only is also included for comparison.   "
255503|NCT03066050|"     This study is a continuation of two previous studies --- the Severe Ischemic Mitral     Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR)     Trial (NCT00806988) --- to learn more about patients' health 5-10 years after their mitral     valve surgeries. The investigators will collect long-term health information on SMR and MMR     trial participants using electronic medical records, patient and/or family input, public     records, and healthcare- and vital status-related databases.   "
255504|NCT03039478|"     Xylitol and erythritol have become increasingly popular as sugar substitutes in the food     industry. Both substances are freely available. While glucose ingestion stimulates satiation     hormone secretion in the gut and slows down gastric emptying, artificial sweeteners such as     aspartame, sucralose and acesulfame-K have no such effect. However, acute intake of 50g     xylitol or 75g erythritol in 300mL tap water leads to a marked increase in the satiation     hormones and induces a significant retardation in gastric emptying. The concentrations used     to Show this effect were rather high (50g xylitol and 75g erythritol) and led to bloating and     diarrhea in 60-70% of all subjects two hours after administration. The aim of the present     study is to find an effective concentration of xylitol and erythritol still stimulating     satiation hormone release without any gastrointestinal adverse events.   "
255508|NCT03091127|"     With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data     is available yet on how the drug is being used outside of the clinical trial setting.      This study will therefore provide essential data to demonstrate the real world utilization of     carfilzomib in routine clinical practice, including dosage, administration schedule, regimen,     duration of treatment and reason for discontinuation in Europe.   "
255509|NCT03053466|"     The purpose of this study is to determine the safety, tolerability, and recommended dose of     CBT-501 in individuals with advanced or relapsed or recurrent solid tumors.   "
255510|NCT03033576|"     This randomized phase II studies how well ipilimumab with or without nivolumab work in     treating patients with melanoma that is stage IV or stage II and cannot be removed by     surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the     ability of tumor cells to grow and spread.   "
255512|NCT03038711|"     The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and     well tolerated in healthy patients.   "
255515|NCT03035929|"     In this pilot study, the investigators will determine the response of the natriuretic peptide     (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The     goal of the proposed project is to generate preliminary data that will be used to develop     power calculations, inform cutoff ranges, and inform the timing of the NP response for larger     subsequent studies aimed at developing a diagnostic test for NP deficiency, which has     important implications for cardiometabolic risk. The investigators propose a pilot study in     10 healthy lean individuals.      Aim: To determine the range of distribution and time course of natriuretic peptide (NP)     responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.      Hypothesis: Determination of the NP responses (the range and time course of changes in NP     levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency     of blood sampling in a definitive prospective study designed to understand the diagnostic     values/cutoffs of a diagnostic test, as well as enable investigators to perform a sample size     calculation for a definitive prospective study.   "
255517|NCT03030599|"     This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the     efficacy and safety of JZP-258.   "
255520|NCT03041285|"     The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in     combination with palliative radiotherapy for metastatic prostate cancer   "
255521|NCT03037385|"     This is a Phase 1, open-label, first-in-human study designed to evaluate the safety,     tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic     activity of BLU-667 administered orally in patients with NSCLC, thyroid cancer and other     solid tumors.   "
255522|NCT03029286|"     This trial will test a decision support web based intervention for women at increased risk     for breast cancer due to breast density and other risk factors (age, race/ethnicity, family     history of breast cancer, history of prior breast biopsies), and to consider MRI and/or     chemoprevention to manage their breast cancer risk.   "
255523|NCT03039764|"     To evaluate the effects of virtual reality-based rehabilitation (Neofect Glove) for newly     diagnosed cognitively intact adult dominant hemisphere stroke patients with paresis of their     hand in supplementation with conventional occupational therapy to assess whether it improves     motor function and speed recovery during inpatient rehabilitation versus conventional     occupational therapy alone. Also, what impact does this have on quality of life.   "
256201|NCT00993889|"     We would like to determine whether Virtual Reality (VR) analgesia continues to be effective     for reducing pain when administered for a clinically relevant treatment duration over     multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).   "
255534|NCT03017872|"     D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line     antiretroviral therapy (ART). The study compares a novel regimen of second-line ART     (dolutegravir and darunavir pharmaco-enhanced with ritonavir) with the WHO recommended     regimen of 2(t)NRTIs plus a ritonavir-boosted PI (Standard of Care (SOC)). 610 participants     from 10 predominantly low-middle income countries will be followed for 96 weeks with the     primary endpoint at week 48. The design is based on the hypothesis that the new regimen will     be non-inferior to SOC in terms of virologic control while being easier to take, economically     viable and affording simplification of treatment programs.   "
255535|NCT03007147|"     This randomized phase III trial studies how well imatinib mesylate and combination     chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive     acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving imatinib mesylate and     combination chemotherapy may work better in treating patients with Philadelphia chromosome     positive acute lymphoblastic leukemia.   "
255536|NCT03001882|"     The purpose of this study is to explore the possible links between patient characteristics     and their cancer, with how effective the combination of nivolumab with ipilimumab is, in     patients with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).   "
255537|NCT03006315|"     Enrolled participants health status will be tracked by using a mobile health-monitoring     device while undergoing chemotherapy for multiple myeloma.   "
255538|NCT03001011|"     Primary Objective:      To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in     hyperphosphatemia in patients with chronic kidney disease not on dialysis.      Secondary Objectives:      To document the efficacy of Renvela tablets in the reduction of serum lipids (total     cholesterol and low-density lipoprotein cholesterol [LDL-C]) To document the efficacy of     Renvela tablets in the reduction of calcium-phosphorus product.      To document the efficacy of Renvela tablets in the reduction of intact parathyroid hormone     (iPTH).      To document the efficacy of Renvela tablets in proportion of patients reaching the target     serum phosphorus level (4.6 mg/dL [1.47 mmol/L], inclusive).      To evaluate safety of Renvela tablets.   "
255539|NCT02996110|"     The purpose of this study is to determine whether nivolumab in combination with other     therapies is more effective than nivolumab in combination with ipilimumab in treating     patients/subjects with advanced renal cell carcinoma.   "
255541|NCT02998047|"     1. Establish the MTD of fractionated doses of Lintuzumab-Ac225 as monotherapy        2. Establish overall response rate (ORR) where ORR = CR + sCR+ VGPR+PR)        3. Confirm the safety profile of the treatment regimen        4. Determine changes in plasmocyte, T-cell and MDSC cell populations        5. Estimate progression-free survival (PFS) and overall survival   "
255542|NCT02997423|"     This is a multi-institutional, consortium-based, non-interventional prospective blinded     endpoints clinical study to determine whether high activity of Cytochrome C Oxidase (CcO) in     tumor specimens from subjects with newly diagnosed primary GBM is associated with shortened     OS (primary outcome) and PFS (secondary outcome) times.   "
256282|NCT03271138|"     The primary purpose of this randomized, double-blinded, placebo-controlled, crossover     clinical trial is to evaluate the efficacy of dietary supplementation with Bifidobacterium     infantis NLS super strain among celiac disease patients on a gluten-free who have persistent     gastrointestinal symptoms.   "
255551|NCT02974751|"     The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the     treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia     (BPH).   "
255552|NCT02982122|"     Despite improvements in management, mortality in severe traumatic brain injury (TBI) remains     25% and only 40% of patients survive without major handicap. Medical/surgical interventions     aim to maintain adequate brain perfusion, which is critically dependent on cerebral perfusion     pressure (CPP); calculated as the difference between mean arterial pressure (MAP) and     intracranial pressure (ICP). Current guidelines aim for a CPP above 50 mmHg, based on     population means. However, this 'one size fits all' approach is flawed, because the relation     between CPP and brain perfusion varies between individuals. Further, this approach takes no     account of autoregulation, a key protective mechanism that maintains cerebral perfusion     despite CPP fluctuations.      Autoregulation is variably preserved following TBI, and there are large between patient     variances in the 'optimal' CPP (CPPopt) at which autoregulation operates best. Individual     CPPopt can be retrieved automatically by plotting autoregulation data against the CPP over a     certain time window. The investigators have shown that maintenance of CPP close to CPPopt is     associated with improved outcomes. These data pose the hypothesis that optimisation of     management in individuals may be achieved by using the zone of optimal autoregulation as a     basis for defining individualised CPP targets.      The investigators propose, together with collaborators in the CPPopt study group (Maastricht,     Cambridge, Leuven and Aachen) to set up a pilot (multicenter) feasibility study to develop a     protocol for a definitive outcome randomized controlled trial (RCT). This study aims to     develop protocols for CPPopt guided critical care, and show that they maintain patients     closer to their optimum perfusion levels than standard protocols which keep above a     population CPP threshold of 60 mmHg.      Hence, the main objective is to offer clinicians monitoring and therapy algorithms that     achieve individualized optimal CPPopt targets and potentially improve TBI outcome.   "
255553|NCT02985957|"     The purpose of this study is to determine whether nivolumab plus ipilimumab has preliminary     evidence of safety and effectiveness in treatment of metastatic castration-resistant prostate     cancer   "
255555|NCT02981472|"     To investigate the safety and pharmacokinetics of apixaban in children with congenital or     acquired heart disease who have a need for anticoagulation.   "
255557|NCT02967237|"     Primary Objective:      The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes     mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible     for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c)     improvement.      Secondary Objectives:        -  Evolution of fasting plasma glucose        -  Evolution of insulin dose and body weight        -  Hypoglycemia incidence        -  Safety        -  Patients satisfaction when they change their insulin for HOE901-U300   "
255558|NCT02967263|"     -  To investigate the etiology and epidemiology of acute kidney injury (AKI).        -  To find out risk factors associated with the occurence of AKI.        -  To find out risk factors related to the prognosis of AKI,focusing on uremic toxins,          inflammation, oxidative stress and nutritional status.        -  To study on the relationship between gene polymorphism and prognosis of acute kidney          injury.   "
255563|NCT02964013|"     This is a safety, efficacy, and pharmacokinetics study of MK-7684 as monotherapy and in     combination with pembrolizumab (MK-3475) in adults with metastatic solid tumors for which     there is no available therapy that is expected to convey clinical benefit. Part A of this     study is a dose escalation phase. Part B is a dose confirmation phase to estimate the     recommended Phase 2 dose (RPTD) for MK-7684 monotherapy or in combination with pembrolizumab.     The anti-tumor activity of MK-7684 when used as monotherapy and in combination with     pembrolizumab in participants with advanced solid tumors will be evaluated in Part B in a     non-randomized study design. Part B will also evaluate 2 doses of MK-7684 in combination with     pembrolizumab in participants with programmed death 1 (PD-1) treatment naïve cancer using a     1:1 randomized study design. The primary hypothesis is that MK-7684 administered as     monotherapy or in combination with pembrolizumab is safe when administered at the RPTD.   "
255566|NCT02963922|"     This trial is conducted globally. The aim of this trial is to investigate effect and safety     of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus     treated with basal insulin.   "
255569|NCT02957968|"     This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of     immunotherapy consisting of sequential decitabine followed by pembrolizumab administered     prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced     HER2-negative breast cancer. The primary efficacy objective is to determine if the     immunotherapy increases the presence and percentage of tumor and/or stromal area of     infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. Efficacy     will be evaluated in 2 cohorts based on hormone receptor status.   "
255570|NCT02960334|"     Atrial Fibrillation (AF) It is the most common arrhythmia in the world. It carries great     public health significance because of its prevalence, additional morbidity and mortality. It     provides a 4-5 times higher risk of developing a ischemic stroke or transient ischemic     attack. In term, this risk can be 70% reduced by taking oral anticoagulants. Actionable AF is     the overarching term for silent AF (asymptomatic AF) and undertreated AF (known AF, but not     sufficiently protected against ischemic stroke). It is recommended that over the age of 65,     patients should be screened with pulse palpation or rhythm strip for the presence of AF. The     MyDiagnostick is a single-lead I, compact hand-held device that analyses heart rhythm during     one minute. During preoperative consultation, this device will be used to value the yield of     screening for actionable AF.   "
255571|NCT02954874|"     This randomized phase III trial studies how well pembrolizumab works in treating     triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere     with the ability of tumor cells to grow and spread.   "
255572|NCT02956382|"     This is a phase I/II study in which patients will be enrolled in a standard 3+3 design. Once     the maximum tolerated dose (MTD) is determined amongst patients with relapsed or refractory     grade 1-3a follicular lymphoma, there will be a 17-patient phase II study.   "
255577|NCT02957942|"     Focal dystonia is a neurological movement disorder characterized by excessive involuntary     muscle contractions of any body part. Spasmodic dysphonia (SD) is a type of focal dystonia     characterized by excessive contraction of intrinsic muscles in the larynx, leading to     difficulty in speaking and affecting effective communication. The cause of SD is unknown and     there are no treatments that produce long-term benefits. Previous studies have suggested that     SD and other focal dystonias are associated with decreased inhibition in sensorimotor areas     in the brain. However, no studies have investigated the effects of modulating excitability of     the laryngeal motor cortex in healthy individuals or SD. The goal of this pilot project is to     determine if brain excitability of the laryngeal motor cortex can be changed with     low-frequency inhibitory repetitive transcranial magnetic stimulation (rTMS) in individuals     with SD and healthy controls. Considering that rTMS at low frequencies (≤1 Hz) produces     lasting inhibition in the brain, and that SD is associated with decreased cortical     inhibition, the purpose of this pilot study is to determine safety, feasibility and response     to 1Hz rTMS to the laryngeal motor cortex in individuals with SD and healthy people. The     results will help understand changes associated with the disorder, as well as contribute to     the development of future clinical interventions for SD.   "
255578|NCT02948257|"     The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE     Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion     of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths     via an antegrade approach.   "
255579|NCT02961413|"     This is a multi-center, prospective, non-interventional cohort study .      Its primary objectives are:        1. assess DILI patients' clinical characteristics, disease progression and influencing          factors in clinical practice;        2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities          mode, etc.   "
255580|NCT02985229|"     To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home     administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70     days LMP will be feasible and acceptable in Singapore.   "
255582|NCT02935634|"     The purpose of this study is to determine whether Nivolumab in combination with other     therapies is more effective than Nivolumab in combination with Ipilimumab in treating     patients/subjects with advanced gastric cancer.   "
255585|NCT02949388|"     This study is designed as a randomized, double blind, parallel group, placebo-controlled     trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily     for twelve weeks to subjects with moderate to severe chronic plaque psoriasis.   "
255587|NCT03000205|"     Using hypertonic dextrose water for chronic supraspinatus tendonitis and using ultrasound as     assessment tool to evaluate the effect of intervention.   "
255588|NCT02930330|"     The purpose of this study is to determine whether high intensity interval training (INT) is     more effective in suppressing platelet reactivity than continuous, moderate intensity     training (CONT) in patients undergoing cardiac rehabilitation after percutaneous coronary     intervention.   "
255626|NCT02875223|"     Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion,     First-In-Human (FIH) clinical study of CC-90011 in subjects with relapsed and/or refractory     solid tumors (including neuroendocrine carcinomas (NEC)) and Non-Hodgkin's lymphomas (NHLs).     The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011     to estimate the maximum tolerated dose (MTD) of CC-90011.   "
255593|NCT02923492|"     The translation study aims to refine and package intervention and training materials     essential to translating an efficacious Emergency Department (ED) based Brief Intervention     (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist     remotely. The study will take place in two phases. During the Effectiveness phase, we will     determine the effectiveness of the interventions [on-site therapist delivered BI + text     messages (n=133); remote therapy delivered BI + text messages (n=133)], as compared to a     usual care control (brochure; n=133), on violence outcomes at 3 months. Note that tailored     text messages will be delivered daily for the first month post-discharge, and three times per     week in the second month post-discharge to the BI groups. During the Implementation phase,     components of the RE-AIM model will be assessed over a 4-month period.   "
255594|NCT02923921|"     To compare the efficacy of AM0010 in combination with FOLFOX versus FOLFOX alone in patients     with metastatic pancreatic cancer as measured by overall survival   "
255597|NCT02921698|"     A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED®     device in the treatment of intracranial aneurysms.   "
255598|NCT02927171|"     This study seeks to improve rehabilitation methods for restoring physical function with     skilled nursing facility care. More specifically, this study is designed to evaluate the     effectiveness of an intensive therapeutic rehabilitation program for older adult skilled     nursing home residents compared to usual care.   "
255599|NCT02915159|"     The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in     patients with Sjögren's Syndrome.   "
255600|NCT02914522|"     The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in     the induction and maintenance treatment of moderately to severely active ulcerative colitis     (UC) in participants who are biologic-naive and biologic-experienced.      Participants who complete the study, or do not meet protocol response or remission criteria     at Week 10 will have the option to enter a separate, long-term extension (LTE) study (Gilead     Study GS-US-418-3899).   "
255602|NCT02911948|"     Comparing the efficacy and safety of insulin degludec/liraglutide and insulin degludec both     in combination with metformin in Japanese subjects with type 2 diabetes mellitus inadequately     controlled with basal or pre-mix/combination insulin therapy and oral anti-diabetic drugs   "
255603|NCT02921750|"     The investigation is designed as an open, randomized, non-inferiority, multi-centre     investigation.      212 subjects will be randomised (subjects lost to follow-up will be replaced). Subjects to be     included will suffer from an exuding venous or mixed ulcer of predominantly venous origin.     Subjects will either be randomized to Exufiber® or Aquacel® Extra using centralized     randomization   "
255604|NCT02919735|"     Phase II clinical trial   "
255683|NCT02788279|"     This is a Phase III, multicenter, open-label, three-arm, randomized study in participants     with unresectable locally advanced or metastatic colorectal cancer (CRC) who have received at     least two prior regimens of cytotoxic chemotherapy for metastatic disease. The study compares     regorafenib, a standard of care therapy in this setting, to cobimetinib plus atezolizumab and     atezolizumab monotherapy.   "
255608|NCT02908815|"     The main objective of this study is to investigate the effects of repetitive Transcranial     Magnetic Stimulation (rTMS) treatment on patients with probable early or moderate Alzheimer's     disease.   "
255610|NCT02902198|"     The objective is to investigate neuro-anatomical correlates of gastrointestinal taste     stimulation by means of functional MRI before and after bariatric surgery. Intragastric     administration of glucose, monosodium glutamate, chloroquine and placebo is followed by     functional brain MRI in obese humans before and 3 months after surgery.   "
255611|NCT02901886|"     This study aims to test the effect of an intensive smoking cessation intervention     (motivational counseling combined with nicotine replacement) on smoking cessation and disease     activity in patients with Rheumatoid Arthritis (RA). Half of the patients will participate in     a smoking cessation intervention; the other half will receive usual treatment.   "
255613|NCT02899195|"     Patients with pleural mesothelioma that can not be surgically removed will receive     durvalumab, in combination with standard chemotherapy of pemetrexed and cisplatin as     first-line treatment.      Durvalumab is a type of drug called a monoclonal antibody (a type of protein). Laboratory     tests show that it works by allowing the immune system to detect your cancer and reactivates     the immune response. This may help to slow down the growth of cancer or may cause cancer     cells to die.      The purpose of this study is to see whether adding durvalumab to standard chemotherapy will     improve overall survival (OS).   "
255614|NCT02908451|"     This study is to define the safety profile and to determine the maximum tolerated dose (MTD)     and preliminary efficacy of AbGn-107 administered every 28 days (4 weeks) in patients with     chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal or pancreatic     adenocarcinoma.   "
255615|NCT02899299|"     The purpose of this study is to test the effectiveness and tolerability of the combination of     Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with     unresectable pleural mesothelioma.   "
256283|NCT03269565|"     An International Multicenter Open-label Randomized Trial of the Efficacy, Pharmacokinetics,     Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) as Monotherapy in Patients with     Unresectable/Metastatic Melanoma.   "
255619|NCT02888743|"     This phase II trial studies the side effects of durvalumab and tremelimumab and to see how     well they work with or without high or low-dose radiation therapy in treating patients with     colorectal or non-small cell lung cancer that has spread to other parts of the body.     Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of     tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells     and shrink tumors. Giving durvalumab and tremelimumab with radiation therapy may work better     in treating patients with colorectal or non-small cell lung cancer.   "
255621|NCT02883374|"     The purpose of this trial is to evaluate the efficiency and safety of Chidamide in advanced     cephalic and cervical adenoid cystic carcinoma. Chidamide is given to patients with advanced     cephalic and cervical adenoid cystic carcinoma with the dosage of 30mg,twice a week, then     overall survival, event-free survival are accessed for efficiency, and laboratory tests about     the function of vital organs are accessed for safety.   "
255629|NCT02881515|"     Excess dietary salt increases the risk for cardiovascular events, even in people that are not     hypertensive. There is some evidence that excess dietary salt exaggerates blood pressure and     sympathetic nervous system responses to various perturbations and increases blood pressure     variability. This proposal will examine the effects of low, medium, and high salt diets on     cardiovascular reactivity and blood pressure variability.   "
255630|NCT02926898|"     The primary purpose of this study is to evaluate the safety, tolerability and efficacy of a     single dose of ZX008 (Fenfluramine Hydrochloride) when added to standard of care and when     added to Adjunctive Antiepleptic therapy to Stiripentol treatment in children and young     adults with Dravet Syndrome   "
255632|NCT02864251|"     The purpose of this study is to determine whether Nivolumab+ chemotherapy and     Nivolumab+Ipilimumab is effective in the treatment of patients with EGFR mutation, T790M     negative NSCLC who failed first line (1L) EGFR TKI therapy   "
255633|NCT02861534|"     This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event     driven study of vericiguat (MK-1242) in participants with HFrEF. The primary hypothesis is     vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the     composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants     with HFrEF.   "
255634|NCT02860806|"     The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of single     escalating intravenous (IV) doses of JNJ-63623872 administered as a continuous infusion; to     evaluate the safety and tolerability of single escalating IV doses of JNJ-63623872     administered as a continuous infusion; to characterize the single-dose PK of JNJ-63623872 of     one selected dose administered as a continuous IV infusion at various durations and to     characterize the single- and repeat-dose PK of JNJ-63623872 administered as a continuous     infusion.   "
255635|NCT02859896|"     Primary Objective:      Evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid     hormone (iPTH).      Secondary Objectives:        -  Evaluate the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol)          capsules.        -  Determine the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration          of Hectorol®.   "
255636|NCT02867683|"     This study evaluates the use of vibrotactile feedback to traditional vestibular treatment     protocols. Half the patients will have vibrotactile feedback added to their treatment     protocols while the other half will undergo traditional vestibular treatment without     vibrotactile feedback.   "
255637|NCT02858713|"     Medical adherence to topical corticosteroid products in psoriasis patients is a main     determinant for poor treatment effect.      The investigators aim to test if a multifaceted intervention delivered in an app (MyPso     QualityCareTM owned by Leo Pharma) for smartphones combined with an Electronic Monitor (EM)     (Teslo) can improve medical adherence among psoriasis patients treated with a topical     calcipotriol/betamethasone dipropionate foam combination (Cal/BD) (Enstilar©).      The study is classified as a phase 4 study, since it is studied if improved use of Enstilar©     results in improved treatment outcomes.   "
255640|NCT02855684|"     Primary Objective:      To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated     hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients     with type 2 diabetes mellitus.      Secondary Objectives:        -  To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and          nocturnal hypoglycemia.        -  To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values          (all and reaching target without hypoglycemia).        -  To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all          and reaching target without hypoglycemia).        -  To compare the frequency of occurrence and diurnal distribution of hypoglycemia by          category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe,          probable and relative).        -  To assess the safety and tolerability of insulin glargine (U300).        -  To assess the development of anti-insulin glargine antibodies (AIA).   "
255641|NCT02851407|"     This study is to compare the efficacy and safety of defibrotide versus best supportive care     in the prevention of hepatic veno-occlusive disease (VOD) in adult and pediatric patients     undergoing hematopoietic stem cell transplant who are at high risk or very high risk of     developing VOD.   "
255643|NCT02848248|"     The study will examine the safety profile of SGN-CD123A. The study will test increasing doses     of SGN-CD123A given every 3 weeks to patients.   "
255649|NCT02835989|"     Community Paramedicine @Home (CP@Home) is a novel community paramedicine health assessment     program for high users of Emergency Medical Services (EMS). Individuals who have been     identified as active callers to EMS, individuals who have called EMS for lift-assists, and     direct paramedic referrals are referred into the community paramedicine home visit program.     The program will focus on in-home chronic disease management, community health service     connections, and EMS usage education. Aside from chronic disease management, aspects of the     program include health-related quality of life, social isolation and other social     determinants of health. Participants in the program will have up to 3 one-on-one home visits     from a community paramedic to ultimately reduce repeat EMS calls and improve their overall     health.   "
255653|NCT02837445|"     The purpose of this double blind randomized study is the evaluation of the safety and     efficacy of the Moderato System. The Moderato pacemaker is indicated for patients who require     a dual chamber pacemaker and also have hypertension, in order to reduce their blood pressure.   "
255705|NCT02752828|"     Primary Objective:      To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to     Week 26 in patients with type 2 Diabetes.      Secondary Objective:      To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without     OADs) over a 26 Week treatment period in patients with type 2 Diabetes.   "
255706|NCT02749890|"     Primary Objective:      To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to     Week 26 in patients with type 2 diabetes mellitus.      Secondary Objective:      To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs)     over a 52 week treatment period in patients with type 2 diabetes mellitus.   "
255709|NCT02759042|"     The primary objective is to provide continued access to PRO 140 to a subject who has     completed participation in PRO140_CD02.   "
255663|NCT02815124|"     Cochlear implants are surgically implanted devices which restore the ability to hear to the     hearing impaired. While remarkably successful, even in the best of performers restoration of     hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery,     cochlear implants are activated via mapping - a process in which each individual electrode     (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the     stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At     present, this standard of care mapping procedure is performed without knowledge of the     physical location between the cochlear implant electrodes and the neural interface. Our team     has developed a new method of mapping using post-operative CT scans and image processing to     specify the physical relationship between the cochlear implant electrodes and the neural     interface allowing customized mapping. Using this information, the investigators deactivate     sub-optimally positioned electrodes. The investigators term this Image-guided Cochlear     Implant Programming (IGCIP). In a prospective fashion, the investigators have implemented     IGCIP on cochlear implant recipients who have had at least 6 months of standard of care (SOC)     mapping. The purpose of this study is to perform a randomized controlled trial (RCT) on newly     activated cochlear implant recipients randomizing between IGCIP and SOC.   "
255656|NCT02832232|"     There are different inhibition suboccipital techniques, usually adjuvant of physiotherapy,     for treatment of patients with chronic neck pain. In our clinical practice, a favorable     effect is observed on patients with chronic neck pain, but there are no published studies     evaluating the results of this techniques on pain, mobility and disability.      The objective of this trial is to evaluate if the suboccipital manual techniques, provides     further improvement in pain intensity, neck disability, range of motion, on patients with     chronic mechanical neck pain and rotation deficit of the upper cervical spine, being treated     with physiotherapy. For this purpose, investigators conduct a double-blind (patient and     evaluator) randomized controlled trial, in a Public Primary Care Center.      Seventy four subjects will be randomized (computer application) into three groups:     Mobilization Group, Maintained pressure Group and Control Group. All the three groups receive     the same protocolized physiotherapeutic treatment during three weeks and, additionally, the     Mobilization Group receives six sessions (two sessions in a week during three weeks) of     translational dorsal glide mobilization technique grade III of the atlanto-occipital joint     and the Maintained pressure Group receives six sessions (two sessions in a week during three     weeks) of pressure maintained suboccipital Inhibition technique. The Control Group receives     the protocolized physiotherapeutic treatment only.      Pain intensity (VAS), Neck Disability Index (NDI), Range of motion (CROM), will be measured     at baseline, after treatment period, and three months after discharge from treatment. After     discharge for treatment the patient subjective opinion about their evolution will be     collected through a Global Rating of Change (GROC) scale, and evaluation of headache     disability (HIT-6).   "
255658|NCT02825940|"     This Phase I, open-label, multicenter study will evaluate the pharmacokinetics, safety, and     preliminary anti-tumor activity of atezolizumab as monotherapy in Chinese participants with     locally advanced or metastatic gastric cancer, nasopharyngeal cancer, esophageal cancer, and     hepatocellular carcinoma (HCC) that are refractory to standard therapeutic modalities and for     whom no further standard therapy is available or who have refused standard therapy; and the     safety and preliminary anti-tumor activity of atezolizumab in combination with gemcitabine     and cisplatin in Chinese participants with Stage IV, treatment-naive non−small cell lung     cancer (NSCLC). The study will consist of a pharmacokinetic (PK) phase and an extension     phase.   "
255659|NCT02825251|"     This trial is conducted in Europe and the United States of America (USA). The aim of this     trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of     Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.   "
255662|NCT03270787|"     This study is to evaluate the efficacy and safety of compound danshen dripping pills in     preventing and treating acute mountain sickness.   "
255664|NCT02970877|"     More and more people in Canada and around the world are severely (morbidly) obese, and this     is associated with a high risk for poor blood sugar control (insulin resistance, IR) and     diabetes. Weight loss is often very hard to achieve for morbidly obese patients. Bariatric     surgery is a very effective treatment, but it has some risks and is not available to all     patients. Therefore, alternative treatments are needed.      The gut bacteria (intestinal microbiome) might play a role for the development of obesity and     IR. Several studies in animals have shown that transferring stool from lean mice or humans     into obese animals could lead to weight loss and improve IR. One human study has confirmed     this. The investigators are therefore examining, whether transfer of stool from healthy lean     people into morbidly obese patients with IR will improve blood sugar control, weight, and     other obesity related parameters. This will be done in a randomized controlled trial. Effects     on mental health and the bacterial in the mouth related to gum disease will also be assessed.      If successful, fecal transfer could be a new alternative treatment approach for morbidly     obese patients or those with IR who do not have access to or do not want to undergo bariatric     surgery.   "
255667|NCT02803918|"     Primary Objective:      To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as     compared to placebo in pediatric patients with T2DM.      Secondary Objectives:        -  To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending          doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric          patients with T2DM.        -  To evaluate the change from baseline in fasting and post-prandial plasma glucose          concentrations during a standardized meal test after 3 ascending repeated doses of          lixisenatide in comparison to placebo.   "
255669|NCT02833844|"     The study is divided into 2 parts. The first part of the study will be double-blinded and     will last for 24 weeks. During this time, subjects will be randomized in a ratio of 2:1 to     receive either Repatha (evolocumab) QM or placebo QM.      The second part of the study is a 24-week open label extension period. During this time all     subjects will receive Repatha (evolocumab) QM.      The clinical hypothesis is that subcutaneous Repatha (evolocumab) QM will be well tolerated     and will result in greater reduction of LDL-C, defined as percent change from baseline at     week 24, compared with placebo QM in HIV-positive subjects with hyperlipidemia or mixed     dyslipidemia.   "
255671|NCT02866669|"     The central objective of this proposal is to rigorously compare two strategies designed to     improve BP control in primary care practices serving rural Southeastern African Americans     with low socioeconomic status (SES) living in the Black Belt.      The Agency for Healthcare Research and Quality (AHRQ) Disparities Report identifies     individuals with rural residence, minority ethnicity, and low SES as being at high risk for     poor health outcomes. The Black Belt region stretches from eastern Texas in an arc to     Maryland and includes residents with all 3 of these characteristics - the proverbial triple     threat. This traditionally agricultural region is characterized by steep poverty, low     educational attainment, scarce resources, and mostly African American residents. The Black     Belt is in the heart of the Stroke Belt, a geographic area long recognized to have the     highest cardiovascular disease (CVD) mortality in the US. The AHRQ Disparities Report also     cites that the Southeast has lower quality of care than the rest of the US, thus effective     strategies to optimize CVD prevention in general and hypertension (HTN) control specifically     are urgently needed here.      In year 1 (AIM 1) we're engaging community members (community members who have experience     being community peer advisors or have high blood pressure) to develop the study interventions     and protocols. In years 2-5, the investigators will test these interventions.   "
255674|NCT02807961|"     This is the first study in humans of ELX-02, an advanced synthetic aminoglycoside optimized     as a translational read-through drug (TRID) for the treatment of genetic conditions caused by     nonsense. mutations. This is a classical Phase 1a study designed as a randomized,     double-blinded, placebo-controlled, single dose escalation to evaluate the safety,     tolerability and pharmacokinetics of ELX-02 in healthy adult volunteers.   "
255676|NCT02795780|"     This study will evaluate longitudinal change of tau deposition as measured by 18F-AV-1451     uptake over time.   "
255677|NCT02795507|"     The purpose of this study is to investigate the effects of training of the non-involved upper     limb on the motor ability of the hemiparetic upper limb in patients with unilateral     sensorimotor motor impairments. The secondary aims are to investigate the relation between     lesion characteristics and responsiveness to the treatment, and to study which brain     structures are activated during a task trained in the treatment.   "
255678|NCT02805283|"     The purpose of this study is to evaluate the diabetes related treatment satisfaction for     patients with type 2 diabetes mellitus.   "
255679|NCT02796339|"     The purpose of this study is to assess the effectiveness of a supplement with natural Mastiha     on Inflammatory Bowel Diseases (IBD). U.S. Food and Drug Administration has classified     Mastiha as GRAS. Previous research demonstrates Mastiha's safety, as well as     anti-inflammatory, antimicrobial and antioxidant properties. In addition, the European     Medicine Agency has recently recognized Mastiha as a natural medicine and classified it to     the category of traditional herbal medicines in diarrhea problems, mild dyspeptic disorders,     skin inflammation and healing (EMA/HMPC/46758/2015). Since IBD is a chronic disease     characterized by inflammation and oxidative stress and based on previous small-scale studies,     the present study aims at demonstrating the effectiveness of this supplement adjunct to the     conservative treatment of IBD.      To this end, confirmed IBD patients, with distinguished Ulcerative Colitis (UC) and Crohn's     Disease (CD) will be enrolled based on certain inclusion and exclusion criteria. The staff of     the study will provide detailed information regarding the aims, the methods, anticipated     benefits and potential hazards of the study and all patients will receive the Patient     Information Leaflet (PIL). Ample time (48 hours) will be provided in order to decide whether     they want to participate in the protocol. Each patient agreeing to participate will sign an     Informed Consent document and the staff will explain to patients that they are under no     obligation to enter the trial and that they can withdraw at any time during the trial,     without having to give a reason. A copy of the signed Informed Consent will be given to the     participant.      100 IBD patients will be allocated to either Mastiha or placebo group. The Mastiha group will     receive natural Mastiha supplement at a dose of 2.8 g daily while placebo group will receive     respectively placebo. The intervention will last 3 months for patients in relapse and 6     months for patients in remission. They will receive all the supplements they will consume     during the intervention at the start of the trial. Both groups will continue their medical     treatment, which must be unaltered throughout the trial. Additionally, all patients will     receive standard nutritional advice by dieticians and will be encouraged to report any     adverse effects they may experience during the intervention. The trial will be blinded in all     implicated persons; neither the staff of the trial nor the patients will be aware of which     kind intervention they receive.      Patients are assessed after randomisation according to the following tools:        -  Medical history        -  Dietary history        -  Harvey & Bradshaw Activity Index Assessment        -  Mayo Activity Index assessment        -  Anthropometric data measurement: body weight (kg), height (cm), Body Mass Index (kg/m2)        -  Inflammatory Bowel Disease Questionnaire        -  DNA isolation from whole blood.        -  Biochemical measurements: Complete blood count, albumin, lipid profile, glucose,          electrolytes, liver enzymes, amylase, fibrinogen.        -  Evaluation of inflammation in serum samples. Circulating serum levels of IL-6, IL-8,          IL-17A, IL-17F, IL-18, IL-21, IL-22, TL1A, TGF-β, ICAM-1, MADCAM-1 and E-selectin are          measured), in all active CD and UC patients. Inflammatory markers are also estimated in          stool samples: calprotectin, lactoferrin and lysozyme,        -  Oxidative stress assessment in serum/plasma samples. Oxidised LDL, serum oxidisability          and F2-isoprostanes are quantified.        -  Detection of metabolites and complete metabolomic profile in plasma samples.        -  Stool samples collection for the assessment of gut microbiota in active patients.        -  Genetic and epigenetic profile      Subsequent assessments: There is a biweekly telephone contact with the patients to monitor     compliance and side effects. At the end of the intervention each subject undergoes the     baseline assessment.   "
255681|NCT02791386|"     The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide     analogue (NA) resistance and assess the real-world treatment outcomes and health resources     utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients     with chronic hepatitis B (CHB).   "
255687|NCT02882958|"     The investigators hypothesize software-based fusion/navigation will be accurate to within 3     mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of     prostate US/MRI software-based fusion/navigation technology.   "
255688|NCT02780804|"     This phase I trial studies the side effects and best dose of entinostat in treating pediatric     patients with solid tumors that have come back or have not responded to treatment. Entinostat     may block some of the enzymes needed for cell division and it may help to kill tumor cells.   "
255689|NCT02773368|"     This trial is conducted globally. The aim of this trial is comparing glycaemic control and     safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on     therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2     diabetes mellitus.   "
255693|NCT02787642|"     A phase Ib study of Olaparib with concomitant radiotherapy in locally advanced/unresectable     soft-tissue sarcoma.   "
255694|NCT02761486|"     Regular use of aspirin may reduce the incidence of colorectal cancer (CRC). However, it is     unclear through which mechanism aspirin exerts its effect, in whom it decreases CRC risk and     in whom it causes side effects. Recently, the imbalanced gut microbiome was linked to     inflammation and CRC risk. The main hypothesis for this study is that aspirin may decrease     CRC risk via targeting the gut microbiome. The study will be a randomized placebo-controlled     double-blinded design, recruiting 50 healthy subjects, 50-75 years old, from the PRospective     Evaluation of SEPTin 9 (PRESEPT) cohort living in the greater Twin Cities area, who will     receive either aspirin or placebo for 6 weeks.   "
255695|NCT02769312|"     The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta     Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD.     Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome     measures focusing on changes in PTSD symptom severity and quality of life and     social/occupation functioning.   "
255696|NCT02764281|"     The purpose of this study is to evaluate the efficacy and safety of methotrexate, etoposide,     pegaspargase and dexamethasone (MEDA) chemotherapy and autologous hematopoietic stem cell     transplantation (Auto-HSCT) in patients with stage IV extranodal natural killer/T-cell     lymphoma, nasal type.   "
255698|NCT02770131|"     Review of clinical characteristics of patients who are prescribed Repatha® and how their     treatment is managed.   "
255700|NCT02753530|"     Funding Source - FDA OOPD. The purpose of this study is to evaluate the safety and efficacy     of the study drug, Arimoclomol in IBM patients.   "
255786|NCT02617589|"     The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated     (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every     two weeks in addition to radiation therapy, and then every four weeks. They will be compared     to patients receiving standard therapy with temozolomide in addition to radiation therapy.   "
255703|NCT02750306|"     This study aims to examine the safety and efficacy of suvorexant (MK-4305) to improve sleep     in individuals with Alzheimer's disease (AD). The primary hypothesis for the study is that     suvorexant is superior to placebo in improving insomnia as measured by change from baseline     in polysomnography (PSG)-derived total sleep time (TST) at Week 4.   "
255704|NCT02752412|"     Primary Objective:      To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to     week 26 in patients with type 2 diabetes mellitus.      Secondary Objective:      To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in     patients with type 2 diabetes mellitus.   "
255713|NCT02740179|"     HIV-infected individuals treated with antiretroviral medications are living longer, but have     an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone     called aldosterone, which regulates blood pressure and sodium balance, is elevated in the HIV     population in association with with increased belly fat and altered glucose metabolism.     Elevations in aldosterone hormone may also be associated with abnormal blood flow,     inflammation, and coronary plaque in the heart. This study is being conducted to evaluate     whether therapies to reduce the actions of aldosterone may decrease the burden and     progression of heart disease in the HIV population.   "
255714|NCT02731742|"     This is a non-randomized, open-label study of MK-1966 used in combination with SD-101 in the     treatment of advanced malignancies. The study will include an initial Dose Evaluation phase     to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) by evaluating     Dose Limiting Toxicities (DLTs) on four dose combinations of MK-1966 and SD-101. Following     determination of the MTD/MAD, approximately 20 participants each will be enrolled in two     expansion cohorts to confirm/refine the MTD/MAD.   "
255715|NCT02729259|"     This study is designed to find additional methods to reduce pain during wound care. In this     study the investigators use virtual reality (a form of distraction) in addition to pain     medication during a burn wound care.   "
255716|NCT03264274|"     Various antiangiogenic agents have a modest effect in prolonging overall survival in solid     tumours. In colorectal cancer it is clear that there are some patients in whom bevacizumab     significantly prolongs survival, but it is not effective in the majority of patients.     Biomarker studies using tumour tissue and blood have failed to define a consistent biomarker     that correlates with a beneficial effect of bevacizumab on survival. DCE-MRI can detect     changes in tumour blood flow which, in early phase drug studies, correlated with subsequent     tumour responses, but is too expensive and time consuming to be used in larger scale trials.     DCE-US is a promising biomarker for use in this group of patients with antiangiogenic agents,     as detailed above. The investigators wish to use this technique as a predictive biomarker for     any effects Aflibercept has on OS and PFS in patients with metastatic colorectal cancer     refractory to standard treatment.   "
255717|NCT02735044|"     Primary Objective:      To compare the efficacy of HOE901-U300 to Lantus in terms of glycated hemoglobin (HbA1c)      Secondary Objectives:        -  To compare HOE901-U300 and Lantus in terms of:        -  Percentage of patients reaching target HbA1c and fasting plasma glucose (FPG).        -  To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events          of hyperglycemia with ketosis, and development of anti-insulin-antibodies.   "
255719|NCT02728102|"     The study is designed as a Phase II, multicenter trial of vaccination with Dendritic     cell/myeloma fusions with granulocyte macrophage colony-stimulating factor (GM-CSF) adjuvant     plus lenalidomide maintenance therapy versus maintenance therapy alone or with GM-CSF     following autologous transplant as part of upfront treatment of multiple myeloma (MM). It is     hypothesized that the dendritic cell myeloma vaccine will result in improved response in     patients with multiple myeloma after autologous Hematopoietic Cell Transplant (HCT).   "
255720|NCT02728089|"     This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and     efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) for the treatment of     complicated urinary tract infection (cUTI) including pyelonephritis (uncomplicated or     complicated pyelonephritis and complicated lower urinary tract infection) in Japanese     participants. Efficacy will be primarily assessed by microbiological response defined as     eradication of the baseline pathogen or pathogens.   "
255721|NCT02726581|"     The purpose of this study is to evaluate the safety and effectiveness of several combination     therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized     (assigned by chance) to receive either:      Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone     OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone      There is an equal chance to be assigned to either Group 1 or Group 2. There is a lesser     chance you will be assigned to Group 3. If you are assigned to receive pomalidomide and     dexamethasone only (Group 2) and your disease worsens, you may be eligible to switch to     treatment Group 3.   "
255722|NCT02732457|"     The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell     transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV immune     response.   "
255723|NCT02720744|"     The purpose of this study is to determine whether FT218 is safe and effective for the     treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.   "
255730|NCT02728752|"     Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy     and Safety of Octagam 10% in Patients With Dermatomyositis (ProDERM study)   "
255731|NCT02708186|"     This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of     Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy     bodies (DLB) or Parkinson's disease dementia (PDD).   "
255732|NCT02705989|"     The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics,     and pharmacodynamics following single and multiple ascending oral doses of BMS-986195 in     healthy subjects, and to assess the relative bioavailability of two formulations of     BMS-986195 with or without food.   "
255734|NCT02713529|"     A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in     subjects with select advanced solid tumors.   "
255735|NCT02754076|"     The study's primary objectives are to evaluate the safety and tolerability of BMN 250     administered to subjects with MPS IIIB via an ICV reservoir and catheter and to evaluate the     impact of BMN 250 on cognitive function in patients with MPS IIIB as assessed by the     Development Quotient.   "
255781|NCT02627508|"     This is a research study to examine the tolerability and effectiveness of pregnenolone in     individuals with autism. Pregnenolone is a naturally occurring steroid hormone in the brain     that has been implicated in treating various psychiatric conditions. The investigators hope     to learn the effects and safety of using pregnenolone in reducing irritability and     sensitivity to sensory differences and improving social communication in individuals with     autism. The investigators hope by studying the effects of pregnenolone in more detail, the     investigators can design better ways to treat individuals with autism.   "
255737|NCT02693665|"     To test the efficacy of FACE-TC on key outcomes, the investigators propose using an     intent-to-treat, longitudinal, prospective, multi-site, randomized controlled trial (RCT)     design. Adolescents with cancer, aged 14 up to 20 years, and their families (N=130 dyads;     N=260 participants) will be recruited and randomized to FACE-TC or Treatment as Usual (TAU)     control. Participants will complete standardized questionnaires at baseline and 3, 6, 12, and     18 months post-intervention. Our goal is to assess the extent to which FACE-TC helps     adolescents and young adults with cancer and their families: (1) reach and maintain better     congruence in treatment preferences over time; (2) improve their quality of life; and (3)     document goals of care and advance directives earlier in the course of their potentially life     limiting illness.   "
255739|NCT02687607|"     An observational non-randomized, multi-center, prospective assessment of the clinical utility     of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms     deemed appropriate for endovascular treatment. The population being treated in this Registry     is a subset of the CE marked indication.   "
255740|NCT02817360|"     Purpose and rationale The purpose of this study is to evaluate the effect of high dose     Renin-Angiotensin System (RAS)-antagonists and beta-blocker treatment for the primary     prevention of cardiac events in a population of patients with Type 2 diabetes mellitus (T2DM)     with no evidence of a preexisting cardiac disease. An additional aim is to demonstrate an     interaction between concentrations of amino-terminal pro-B type natriuretic peptide     (NT-proBNP as a surrogate of imminent cardiac risk) and treatment effects and the economic     impact of the intervention overall and in the biomarker stratified subgroups.      Primary objective Superiority of high dose treatment with RAS-antagonists and beta-blockers     compared to conventional therapy regarding the reduction of unplanned hospitalization or     death due to a cardiac event in T2DM patients with a NT-proBNP > 125pg/ml.      There is an additional eye-substudy for Viennese sites only. The purpose of this sub-study is     to evaluate the effect of high dose RAS-antagonists and beta blocker treatment on early     subclinical signs of diabetic micro-angiopathy and neuropathy. An additional aim will be the     evaluation of the possible impact of the cardiovascular risk factor NT-proBNP on the onset     and progression of diabetic retinopathy.   "
255745|NCT02741076|"     The purpose of this study is to evaluate the effect on pain intensity (PI) of structured     discontinuation of long-term opioid analgesic therapy compared to continuation of opioid     therapy in Suboptimal and Optimal Responders to high-dose, long-term opioid analgesic therapy     for chronic low back pain (CLBP).   "
255748|NCT02682927|"     This is a multicenter, double-blind, parallel-group, placebo-controlled, study to assess the     efficacy, safety, and PK of ZX008 when used as adjunctive therapy for uncontrolled seizures     in pediatric and young adult subjects with Dravet syndrome. After an initial Screening and     Baseline charting of seizure frequency, subjects who qualify for the study will be randomized     (1:1:1) to receive either ZX008 (0.2 mg/kg/day, 0.8 mg/kg/day; maximum dose: 30 mg/day) or     placebo. Randomization will be stratified by age group (< 6 years, ≥6 to 18 years). All     subjects will be titrated to their randomized dose over a 14-day Titration Period. Following     titration, subjects will continue treatment at their randomly assigned dose over a 12-week     Maintenance Period. Subjects exiting the study will undergo a 2-week taper, unless they     enroll in a follow-on study. Subjects will be followed for post-study safety monitoring.     Parents/caregivers will use a diary daily to record the number/type of seizures, dosing, and     use of rescue medication.   "
255760|NCT03270293|"     Primary end point of the study was to evaluate clinically and by non-invasive instrumental     evaluations tolerance and efficacy of a bio-revitalizing product containing hyaluronic acid     with high (H-HA) and low (L-HA) molecular weight; the micro-injection of the study product     was performed by a specialized dermatologist, bilaterally on the face (zygomatic     protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular     angle) of healthy female volunteers aged 30-60 years.      It was also aim of this study to evaluate efficacy by the volunteers and tolerance both by     investigator and volunteers.   "
255761|NCT02658890|"     The purpose of the study is to determine safety and effectiveness of experimental medication     BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab     in patients with cancers that are advanced or have spread. Pharmacokinetics and     pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab     and Ipilimumab in this patient population will also be assessed.   "
255750|NCT02677740|"     The aim of this project is to increase our understanding of how two different protocols of     repetitive transcranial magnetic stimulation (rTMS), inhibitory (1 Hz) and excitatory (5 Hz),     applied over the primary motor cortex of the presumed dominant hemisphere, affect functional     connectivity and neurochemistry in the brain.   "
255752|NCT02680223|"     This is a randomised controlled trial with the aim of testing the efficacy of coloured     overlays and coloured lenses for the relief of visual stress and reading difficulties in     children and young adults.   "
255754|NCT02673502|"     Enhanced Recovery after Surgery (ERAS) pathways include multiple evidence-based interventions     delivered throughout the peri-operative period that aim to attenuate the surgical stress     response and support rapid physiologic and functional recovery.A key element of the ERAS     pathway is the administration of a clear carbohydrate-rich beverage 2-3 h before surgery in     order to keep the patient in a fed state rather than a fasted state when they go to the     operating room. The aim of the current study is to investigate the impact of a drink     containing simple carbohydrate on attenuating surgical stress induced insulin resistance in     patients undergoing major laparoscopic abdominal surgery, compared to drinks containing     maltodextrin.   "
255755|NCT02670915|"     This trial is conducted globally. The aim of the trial is to investigate efficacy and safety     of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin     degludec in children and adolescents with type 1 diabetes.   "
255756|NCT02668653|"     This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of     this study is to compare the effect of quizartinib versus placebo (administered with standard     induction and consolidation chemotherapy, then administered as maintenance therapy for up to     12 cycles) on event-free survival in subjects with FLT3-internal tandem duplication (ITD)     positive AML.   "
255759|NCT02662621|"     Recent studies shows that extracellular vesicles (named exosomes) released by cancer cells     exhibit at their membrane the stress protein HSP70, contrary to exosomes released by normal     cells. These exosomes (HSP70-exosomes) have a very important role in intercellular     communication and have specific biological functions that can promote tumor progression. They     are found in the different biological fluids such as blood and urine.      We have developed a protocol able to isolate exosomes in blood and urine. We also     demonstrated that only exosomes derived from cancer cell have HSP70 at their membrane. Those     results strongly suggest that we can only identify exosomes with HSP70 at the membrane in     patients with cancer.      Detection of HSP70-exosomes in the diagnosis of patients is a promising pathway of research.     Because a cancer cell can releases a large amount of exosomes (several billion) and since its     appearance, our approach will allow to earlier detect cancer with respect to the use of     imaging and circulating tumor cells (CTCs), which remains a rare event (about one CTC of 1     billion cells).      The aim of this study is to demonstrate that HSP70-exosomes could be used for early diagnosis     of patients with malignant solid tumor. In order to demonstrate this, the objective of the     study is to study blood and urine samples from 60 subjects with a malignant tumor and 20     healthy subjects (witness).   "
255775|NCT02633046|"     Multicenter, multiple dose study to examine the effect of H.P. Acthar® Gel (repository     corticotropin injection) in adult subjects with idiopathic focal segmental glomerulosclerosis     (FSGS) who have failed to achieve remission with, or who are intolerant of, 1 or more     previous immunosuppressive therapies.   "
255763|NCT02654639|"     Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC   "
255764|NCT02743845|"     The Gene Discovery Core at The Manton Center for Orphan Disease Research based at Boston     Children's Hospital studies families with rare, poorly understood or undiagnosed, but     suspected genetic conditions. The primary goal of the research is to better understand the     genes and proteins (gene products) involved in rare diseases. The researchers hope that our     studies will allow for improved diagnosis and treatment of individuals with rare disease in     the future. Individuals with any rare/undiagnosed condition are eligible to enroll.      Enrollment includes:        -  Providing DNA and tissue samples (when available)        -  Access to participants' medical records      Samples are used for genetic analysis (primarily exome and genome sequencing) to identify the     genetic cause for the individual's illness. Individual research results are returned to     families through their health care provider after confirmation in a clinical lab. If a cause     is identified, that can be reported back to the family through their health care provider and     the study's genetic counselor. When possible, the investigators also collect samples from     parents and full-siblings as well as any other affected family members.   "
255767|NCT02646085|"     Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography     imaging with intravenously injected C11 Methionine to detect viable lesions.   "
255769|NCT02638948|"     The purpose of this study is to determine whether the study drug, BMS-986142, is safe and     effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate     response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors.     Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in     1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the     course of the study.   "
255770|NCT02887547|"     Gingival Crevicular Fluid samples will be collected using periopapers after accelerated tooth     movement technique, results will be achieve with cytokine measurements that will be done     using Luminex Assays and cytometer flow   "
255771|NCT02813564|"     Plasticity refers to susceptibility of an organism to change. Cognitive training is an     intervention approach based on the notion of plasticity. It entails the repeated exercise of     a set of higher-order cognitive abilities over several weeks after which performance gains     are expected on the trained as well as untrained tasks. Cognitive training has produced     successful results in various clinical groups, but its benefits have not been explored in     Autism Spectrum Disorder (ASD). The present study will develop a software-based training     program tailored to the cognitive deficits in ASD. The investigators will also examine     possible training-induced functional changes within the brain using functional Magnetic     Resonance Imaging (fMRI). Fifty children with ASD 3-7 years will be recruited and randomly     assigned to the control (n=25) or the training group (n=25). A subgroup of these samples will     carry out the response inhibition and set-shifting tasks in the fMRI scanner. The study will     consist of a pre-post design and a four-month follow up. Repeated measures Analysis of     Variance (ANOVA) will be carried out with group (training, control) as the between subjects     factor and Time (pre- post-training, follow-up) as the within subjects factor to identify     training induced cognitive improvements. To determine training-induced biological changes     within the brain, activity maps associated with response inhibition and set-shifting at     pre-training and post-training sessions will be entered into a group ANOVA and contrasted for     differences within- and between groups.   "
255772|NCT02643043|"     This comprehensive genomic analysis and biospecimen repository study incorporates Next     Generation Sequencing (NGS) of archival tumor tissue from 200 subjects with metastatic     urothelial cancer in support of several parallel goals. The immediate goal involves     generation of a comprehensive report identifying subject specific genetic mutations and/or     alterations based on NGS. Additionally, DNA and RNA extracted from tumor specimens and any     remaining blocks/slides from the NGS will be stored for future research. Long-term, the goal     of this endeavor is to support collaborative translational research projects in metastatic     urothelial cancer by allowing investigators to interrogate abstracted coded clinical data     linked to data from any biospecimen studies.   "
255773|NCT02638337|"     The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once     daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause     in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.   "
255774|NCT02646787|"     Using virtual reality as a form of distraction during a painful burn wound care procedure in     addition to pain medication.   "
255778|NCT02628067|"     In this study, participants with multiple types of advanced (unresectable and/or metastatic)     solid tumors that have progressed on standard of care therapy will be treated with     pembrolizumab.   "
255787|NCT02616029|"     This study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir     alafenamide (E/C/F/TAF) fixed dose combination (FDC) after switching from a stable regimen     consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine     (ABC/3TC) plus a third antiretroviral agent in participants harboring the archived     nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or     M184I in HIV-1 reverse transcriptase.   "
255788|NCT02612779|"     Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort)     and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of     these combination therapies for treatment of relapsed or refractory MM patients.   "
255792|NCT02617693|"     This study is conducted in Asia. The aim of this study is to assess the efficacy of a     pre-pregnancy life style intervention to reduce the risk of diabetes and prediabetes.   "
255794|NCT02641002|"     Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part     B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with     relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating     doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion     in Part B.      The primary objective is to determine the safety and tolerability of CC-90002 and also to     define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended     Phase 2 dose (RP2D) of CC-90002.   "
255796|NCT02600936|"     The Sinai Vein Stent Registry aims to establish and maintain a registry of patients who have     undergone a vein stent placement procedure at The Mount Sinai Medical Center. The purpose of     this study is to monitor and evaluate the long-term outcomes of venous stents placed to treat     venous outflow obstruction. Outcome variables that will be assessed are: patency rate,     reintervention rate, occurrence of any complications, clinical improvement, and quality of     life. Venous outflow obstruction is defined as a stenosis and/or occlusion seen primarily in     the ilio-femoral vein and inferior vena cava, and infrequently in the subclavian vein,     brachiocephalic vein, or superior vena cava. While vein stent placement procedures are     currently being performed in the United States, using stents which are commercially available     and FDA-approved for use in arterial interventions, at this time there are no stents that are     FDA-approved for use in veins. The placement of stents in veins holds tremendous promise as a     treatment for venous outflow obstruction, but review of current literature has showed a     paucity of published data on the long-term outcomes of this treatment.      The study is composed of two arms, a retrospective arm and a prospective arm. Any patient     over the age of 18 who has undergone or is scheduled to undergo a vein stent placement     procedure is eligible for this study. A HIPAA waiver and waiver of informed consent are being     requested for the retrospective arm for patients who have undergone a vein stent placement     procedure from January 1st 2012 to date of study onset, as it is not possible to contact all     patients in the retrospective arm (i.e., lost to follow-up, no longer follows-up with a study     physician). This study is only interested in the collection and analysis of data; the     clinical care and outcomes of research subjects will not be affected by their participation     in this study.      An IDE application has been submitted to the FDA for use of the Wallstent™ (manufactured by     Boston Scientific, Inc.) in veins as treatment for venous outflow obstruction. The primary     stents being used as treatment for venous outflow obstruction at Mount Sinai is the     Wallstent™, mainly due to the fact that only Wallstents™ are available in the appropriate     sizes to be used in veins. In rare occasions or exceptional circumstances, a smaller     self-expanding nitinol stent may be used. Due to the extremely rare frequency of stents other     than Wallstents™ being used and the impracticality (if not impossibility) of obtaining IDEs     for all other stents, the investigators believe it is appropriate to exclude usage of these     stents from the study data. To confirm, the purpose of this study is to monitor and evaluate     long-term outcomes of the venous stents/the vein stent placement procedure, not specifically     the Wallstent™ itself.   "
255797|NCT02598193|"     This clinical study will evaluate the safety and tolerability of combination treatment of     nintedanib and pirfenidone in participants with IPF. Eligible participants must have received     pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the     study as a combination treatment for IPF for 24 weeks.   "
255801|NCT02599818|"     This study will examine the clinical effectiveness and health economic profile of services to     link hospital patients with substance use disorders to addiction treatment, promote their     medical stabilization, and reduce hospital re-admissions.   "
255803|NCT02606994|"     The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated     healing of chemotherapy-induced oral mucositis.   "
255805|NCT02593123|"     Determine the relapse-free, donor lymphocyte infusion (DLI)-free survival in patients     receiving the investigational regimen.This is a randomized phase II clinical trial, comparing     two different dosing schedules of mycophyenolate mofetil for graft versus host disease (GVHD)     prevention following allogeneic stem cell transplantation. Risk for relapse, GVHD and     non-relapse mortality will be assessed. Adaptive randomization between two study arms will be     performed based on T cell counts at day 60.   "
255806|NCT02592798|"     The purpose of this study is evaluate if abatacept is effective and safe in decreasing the     level of protein loss in the urine in patients with excessive loss of protein in the urine     (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal     change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis.     Another kidney biopsy will not be required as part of the study. Candidates must have failed     or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy     must include corticosteroids and at least one other drug. Candidates can be adults and     children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.   "
255811|NCT02578810|"     Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of     exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity     and mortality worldwide.1 Standardization of antenatal and postnatal assessment and     surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model     of preeclampsia have been associated with reduced maternal morbidity.   "
255813|NCT02574078|"     The purpose of this study is to determine whether nivolumab monotherapy or in combination     with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR)     without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.   "
255814|NCT02575339|"     This is an open label, multi-center, randomized phase I/II study of MLN0128 versus standard     sorafenib. Eligible subjects in the phase I trial will receive MLN0128 in escalating doses.     Eligible subjects in the phase II trial will be 1:1 randomized to either the MLN0128 arm or     the sorafenib arm.   "
255815|NCT02579005|"     This project will assess the feasibility of treating advanced cancer using the immune system,     without any anti-cancer drug. In this pilot study, the investigators propose combining     low-dose radiotherapy, in lung cancer patients, with allogeneic immune cells obtained from a     donor. The patients will receive radiotherapy directed to one of the patient's tumors, as     well as an immunomodulatory drug called cyclophosphamide. Thereafter, they will receive the     infusion of donor immune cells.   "
255821|NCT02559557|"     This pilot clinical trial studies a culturally adapted skills training and educational     intervention in guiding parents of younger acute lymphoblastic leukemia (ALL) or acute     myeloid leukemia (AML) survivors at risk for long-term attention and memory problems (late     neurocognitive effects). ALL and AML treatments target the central nervous system and may put     younger survivors at increased risk for late neurocognitive effects, which may lead to     learning difficulties or behavior problems and poor health-related quality of life.     Spanish-speaking parents of young ALL or AML survivors may not have access to the     information, resources, or guidance to help their children through these difficulties.     Adapting an existing parent-training program into Spanish may help teach Spanish-speaking     parents effective ways to prevent or reduce learning and behavioral difficulties, which may     improve the quality of life of parents and young ALL or AML survivors.   "
255826|NCT02552212|"     Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis     and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP)     200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of     CZP in these patients.   "
255831|NCT02557100|"     The purpose of this study is to examine changes in immune cells and proteins in response to     treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus     adalimumab, both given in combination with methotrexate.   "
255832|NCT02542150|"     This study plans to learn more about how alcohol and its metabolite, acetate, affect the     brain.   "
255833|NCT02538666|"     In this study, all patients must have already completed first-line chemotherapy to treat     extensive-stage disease small cell lung cancer. The purpose of this study is to show that     Nivolumab, or Nivolumab plus Ipilimumab followed by Nivolumab by itself, will prolong overall     survival and progression free survival when administered as consolidation treatment in     patients that are stable or responding after chemotherapy. Patients receiving treatment will     be compared with patients taking placebo.   "
255834|NCT02583672|"     The purpose of this study is to measure levels of blood and brain chemicals related to     oxidative stress and inflammation in healthy volunteers and individuals with Type 1 Gaucher     disease (GD1) to see if these levels are altered by GD1.   "
255836|NCT02681666|"     This pilot study will be a randomized parallel trial comparing Mindfulness-Based Irritable     Bowel Syndrome Eating Awareness Training done over an 8 week period to a standard low     Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols diet.   "
255837|NCT02530918|"     The purpose of this study is to test DS-7080a, a monoclonal antibody, as a new treatment for     neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). The     hypothesis of the study is that DS-7080a is safe and shows preliminary efficacy in patients     with these conditions either alone or in combination with ranibizumab. This study is     organized into 3 Parts: Part 1 Dose Escalation in AMD participants, Part 2 Dose Expansion in     AMD participants, and Part 3 Dose Expansion in DME participants.      In Part 1, participants will be enrolled into 3 sequential, ascending dose-level cohorts in     non-randomized uncontrolled manner with the main purpose to determine the recommended dose.      In Part 2, participants will be randomized to 1 of 3 arms of either monotherapy with DS-7080a     or monotherapy with ranibizumab, which is an active control, or combination therapy of     DS-7080a plus ranibizumab (ranibizumab will be administered 30 minutes prior to DS-7080a).      In Part 3, subjects with DME will be assigned to 1 of 2 arms of either monotherapy with     DS-7080a or monotherapy with ranibizumab. DS-7080a or ranibizumab will be administered 3     times: on Baseline/Day 1, Day 29, and Day 57.      Both Parts 2 and 3 will consist of 8 visits including a 14-day screening phase, an 84-day     treatment period, and a 28-day follow-up period.   "
255838|NCT02521493|"     This phase III trial studies response-based chemotherapy in treating newly diagnosed acute     myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs     used in chemotherapy work in different ways to stop the growth of cancer cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading.     Response-based chemotherapy separates patients into different risk groups and treats them     according to how they respond to the first course of treatment (Induction I). Response-based     treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in     younger patients with Down syndrome while reducing the side effects.   "
255841|NCT02512601|"     This study aims to evaluate whether, in a standardised cohort of patients with mild to     moderate PTS, monitored for a sufficiently long follow-up period, quality of life measured by     generic instruments and disease-specific instruments evolves favourably in this patient     profile.      Study objective: to evaluate the evolution of quality of life in general and in the specific     context of the disease of patients who have experienced an episode of deep-vein thrombosis     (DVT), are affected by post-thrombotic syndrome, are subject to compression therapy and     receive an additional standard venoactive agent (sulodexide 15 mg twice daily during 6     months).   "
255875|NCT02445079|"     Longitudinal cohort study of older-aged people living with HIV infection in southwestern     Uganda and age and gender-matched HIV uninfected controls with the primary aim of measuring     the epidemiology of cardiovascular and pulmonary disease in this study setting, and     particularly the contribution of HIV infection to it.   "
255843|NCT02504372|"     In this study, participants with Stage IB/II-IIIA non-small cell lung cancer (NSCLC) who have     undergone surgical resection (lobectomy or pneumonectomy) with or without adjuvant     chemotherapy will be treated with pembrolizumab or placebo. The primary study hypothesis is     that pembrolizumab will provide improved disease-free survival (DFS) versus placebo.   "
255846|NCT02498600|"     This randomized phase II trial studies how well nivolumab works with or without ipilimumab in     treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that     has not responded after prior treatment (persistent) or has come back (recurrent). Monoclonal     antibodies, such as nivolumab and ipilimumab, may block tumor growth in different ways by     targeting certain cells.   "
255898|NCT02380092|"     LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study     serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™     bearing surface (OXINIUM™ femoral component with highly cross-linked polyethylene tibial     insert).      All study subjects will receive a LEGION™ Primary Total Knee System with VERILAST™ bearing     surface and the results will be analysed against historical data from patients who received a     Genesis II knee replacement.   "
255849|NCT02494583|"     This is a study of pembrolizumab (MK-3475) as first-line treatment for participants with     advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Participants will be     randomly assigned to one of the 3 treatment arms of the study: pembrolizumab as monotherapy,     or pembrolizumab + cisplatin + 5-fluorouracil (5-FU) or capecitabine, or placebo + cisplatin     + 5-FU or capecitabine. The primary study hypotheses are that pembrolizumab in combination     with chemotherapy is superior to chemotherapy alone in terms of Progression-free Survival     (PFS) and Overall Survival (OS) and that pembrolizumab monotherapy is as good as or better     than chemotherapy alone in terms of OS.   "
255851|NCT02503436|"     The main objective of the proposed non-interventional study is to obtain real-world     effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer     Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German     hospitals and outpatient practices treated with olaparib.   "
255852|NCT02492711|"     The purpose of this study is to determine whether patients treated with margetuximab plus     chemotherapy have longer progression free survival and overall survival than patients treated     with trastuzumab plus chemotherapy.   "
255854|NCT02488759|"     The purpose of this study to investigate the safety and effectiveness of Nivolumab, and     Nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain     viruses have been known to play a role in tumor formation and growth. This study will     investigate the effects of the study drugs, in patients who have the following types of     tumors:        -  Anal canal cancer        -  Cervical cancer        -  Epstein Barr Virus (EBV) positive gastric cancer        -  HPV positive and negative squamous cell cancer of the head and neck (SCCHN)        -  Merkel Cell Cancer        -  Nasopharyngeal cancer (NPC)        -  Penile cancer        -  Vaginal and vulvar cancer   "
255856|NCT02500589|"     Smoking is the leading cause of morbidity and mortality in the U.S. Interventions that     increase successful quit attempts among depressed smokers with chronic medical illnesses are     particularly important for the VA healthcare system because rates of tobacco use, depression,     and chronic medical illnesses are significantly higher among Veterans compared to the general     population. Providing smoking cessation services augmented with mood management to Veterans     via telephone may increase access to, and utilization of, evidence-based smoking cessation     counseling and decrease rates of smoking-related complications for Veterans with chronic     medical illnesses and depression. Yet, the reach of smoking cessation telephone counseling     has been limited among populations with mental illness. The investigators intend to combine     the potency of co-delivered mood management and reach of telephone-delivered interventions by     testing the telephone delivery of behavioral mood-management for smoking cessation among     smokers with depression and chronic medical illness.   "
255857|NCT02483078|"     This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy,     safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for     one week and Optimized Background Therapy (OBT) for 24 weeks respectively. Study population     includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates     evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented     genotypic or phenotypic resistance to ART drugs within three drug classes (or within two or     more drug classes with limited treatment options).The options may be limited as a result of     drug antiviral class cross-resistance or documented treatment intolerance.   "
255858|NCT02478398|"     The purpose of this study is to assess the efficacy and safety of MK-3641 (short ragweed     [Ambrosia artemisiifolia] extract, MK-3641, SCH 039641, RAGWITEK™) sublingual immunotherapy     tablets in children aged 5 to 17 years with ragweed-induced allergic     rhinitis/rhinoconjunctivitis with or without asthma. The primary hypothesis of this study is     that administration of MK-3641 sublingual immunotherapy tablets to children 5 to 17 years of     age, compared with placebo, will result in a significant reduction in rhinoconjunctivitis     symptoms and medication use over the peak ragweed season (RS).   "
255859|NCT02834455|"     Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary     pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is     difficult, as the pleural surface is large and <33% of pleural malignancies shed malignant     cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing     mutation status for targeted therapies.      Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than     conventional CT for detecting malignant lesions >10mm. However, no randomised trial has     investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely     PET-positive lesions in e.g. colon however, lead to more derived tests than do CT alone.      Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing     direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical     (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows     only sampling from the parietal pleura. To date, no randomised studies have compared medical     and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.      The investigators will perform two randomized studies to investigate whether        1. PET/CT is comparable to CT alone        2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed,          time-to-diagnosis.   "
255860|NCT02476240|"     The purpose of this study is to evaluate the underlying mechanism and influence of externally     vs. internally focused exercise on rehabilitation in Parkinson's disease. The upcoming     exercise intervention methodology will aim to meet the requirements of a 1A silver ranking     level, single blind, randomized control trial according to the criterion of the Cochrane     Musculoskeletal Review Group   "
255861|NCT02474095|"     This randomized pilot clinical trial studies alternate schedules for acupuncture-like     transcutaneous electrical nerve stimulation (ALTENS) in treating dry mouth (xerostomia)     caused by radiation therapy (RT) in patients with head and neck cancer. ALTENS is a procedure     in which mild electric currents are applied to certain acupuncture points on the body and may     help relieve dry mouth caused by RT and improve quality of life. It is not yet known whether     giving ALTENS more frequently works better than standard ALTENS in treating dry mouth caused     by RT.   "
255944|NCT02284308|"     There is no detailed information available on benefits and harms of intensified treatment     with concurrent RCHT among a subpopulation of elderly patients. Reliable tools are needed to     distinguish the subgroup of fit patients from frail patients.   "
255866|NCT02452216|"     This pilot clinical trial study will assess the inflammatory response of brain tumors or     other central nervous system conditions in pediatric and adult patients using     ferumoxytol-enhanced MRI. Imaging features will be correlated with the number of inflammatory     cells (macrophages) at histopathology. Determining the extent of inflammation associated with     pathologies in the central nervous system may be helpful for diagnostic and prognostic     purposes as well as monitoring treatment response of current and future immunotherapies.   "
255870|NCT02444676|"     Background: Heart failure (HF) is in many cases the final way for coronary heart diseases. In     older than 65 years is the most important cause of hospitalization. Many studies have     analyzed the causes of decompensation and the possible causes of hospital re-admission but     most evidences come from the hospital setting. Nevertheless, It is known that many of these     patients are usually attended in primary care setting, being treated by their General     Practitioner and are not referred to the hospital.      The determinants which condition whether stable HF patients will be hospitalized as a     consequence of a decompensation remain still unclear.      Objective: To develop and validate a predictive model based on clinical variables easy to     measure at primary care to predict short-term hospitalization or mortality in a cohort of     patients attended in primary care setting as a consequence of a HF decompensation.      Methods: A cohort of patients with established HF attended in primary care setting (regular     care or out of hours) as a consequence of an episode of HF decompensation will be follow up.     To develop the predictive model we will select variables which previously have been found     involved in the risk of hospitalization or mortality as a consequence of HF as well as other     ones which could be relevant and have not been studied yet. Variables selected should be     easily determined in primary care setting..      The predictive model obtained in the derivation cohort from Spain will be validated in an     external (several European countries) validation cohort.      Relevance: Our study will help GP to identify HF patients at higher risk of hospitalization     or death and manage them according to an accurate prognostic rule (escala pronostica) made in     primary care setting.[DISCUTIR]   "
255871|NCT02443077|"     This randomized phase III trial studies ibrutinib to see how well it works compared to     placebo when given before and after stem cell transplant in treating patients with diffuse     large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not     respond to treatment (refractory). Before transplant, stem cells are taken from patients and     stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room     for healthy cells. After treatment, the stem cells are then returned to the patient to     replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug     that may stop the growth of cancer cells by blocking a protein that is needed for cell     growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem     cell transplant may help the transplant work better in patients with relapsed or refractory     diffuse large B-cell lymphoma.   "
255872|NCT02446600|"     This randomized phase III trial studies olaparib or cediranib maleate and olaparib to see how     well they work compared with standard platinum-based chemotherapy in treating patients with     platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back.     Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian     tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for     tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine     hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate     and olaparib is more effective than standard platinum-based chemotherapy in treating patients     with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.   "
255873|NCT02443155|"     This trial is conducted globally. The aim of this trial is to assess the clinical     proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in     adult subjects with newly diagnosed type 1 diabetes mellitus.   "
255877|NCT02470754|"     The purpose of this study is to learn more about nicotine exposure and the safety of     electronic cigarettes (EC). It will focus on the areas that are thought to most closely     relate to the addictive potential of EC, namely: (1) EC as nicotine delivery devices,     covering issues of nicotine intake and pharmacokinetics, temporal patterns of use and     titration of nicotine; and (2) subjective effects of EC use, including relationship of use to     reward, withdrawal and craving.   "
255878|NCT02435420|"     This is a retro-prospective, single arm, sequential enrolment study to collect relevant     clinical and radiological data in at least 156 subjects, at up to 10 sites in Australia, who     have been implanted with the EMPERION™ Modular Hip System in primary THA procedures to assess     its safety and efficacy over 5 years post-surgery.   "
255879|NCT02431247|"     The purpose of this study is to demonstrate non-inferiority in efficacy of a     darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination     (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with     Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1     (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.   "
255881|NCT02446561|"     To determine whether three new oral formulations of a strong pain killer release the drug     into the body in a similar pattern as the already marketed reference capsule formulation with     or without food   "
255884|NCT02409368|"     The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades     3-4), treatment-related, select adverse events in patients with advanced or metastatic     Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or     after at least 1 systemic therapy.   "
255887|NCT02427659|"     Using virtual reality as a form of distraction for pain during wound care. Virtual reality     involves looking into a set of goggles and then moving through a computer-simulated world.   "
255890|NCT02416297|"     The purpose of this research study is to assess the clinical effectiveness of a minimally     invasive alveolar microperforation procedure to achieve accelerated tooth movement in     patients undergoing orthodontic treatment for orthognathic surgery. Accelerated tooth     movement means that Microperforation technique may help complete orthodontic treatment     sooner than would be expected in conventional orthodontic treatment   "
255900|NCT02371369|"     This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an     investigational drug PLX3397 in the treatment of tumour of pigmented villonodular synovitis     or giant cell tumor of the tendon sheath in subjects, for whom surgical removal of the tumour     would cause more harm than good. The main purpose of this study is to gather information     about the investigational drug PLX3397, which may help to treat these tumours.      The study consists of two parts. In Part 1, eligible study participants will be assigned to     receive either PLX3397 or matching placebo for 24 weeks. A number of assessments will be     carried out during the course of the study, including physical examinations, blood tests,     imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate     the response of the tumour to the treatment which will be independently assessed by central     readers blinded to the treatment assignment. Those subjects, whether assigned to PLX3397 or     matching placebo, who have completed Part 1 (i.e, complete 24 weeks of dosing and the Week 25     assessments) will be eligible to advance to Part 2, a long-term treatment phase in which all     subjects will receive open-label PLX3397   "
255901|NCT02384603|"     The aim of this study is to compare the effects of two physiotherapeutic treatments of     fibromyalgia: global postural reeducation associated with cognitive behavioral therapy and     segmental muscle stretching exercises associated with cognitive behavioral therapy.   "
255902|NCT02418000|"     This is a Phase 1/2a dose-escalation study of E6201, a dual MEK1 and FLT3 inhibitor, in     subjects with advanced hematologic malignancies with documented FLT3 mutation. The Phase1     portion of the study will be a safety run-in (up to 30 subjects) to establish a recommended     Phase 2 dose (RP2D). The Ph. 2a portion of the study will evaluate two specific patients     groups: Cohort 1 will enroll up to 26 patients with relapsed or refractory AML and confirmed     FLT3 mutation (with or without a Ras mutation) without prior exposure to a FLT3 inhibitor     while Cohort 2 will enroll up to 26 patients with relapsed or refractory AML and confirmed     FLT3 mutation (with or without a Ras mutation) with prior exposure to a FLT3 inhibitor.     Cohort 3 will enroll up to 10 patients with relapsed or refractory AML with a confirmed Ras     mutation and no FLT3 mutation. Cohorts 1 and 2 of the expansion phase will incorporate a     Simon 2-stage optimal design. A total of up to N=92 subjects will be enrolled in the study.   "
255903|NCT02391116|"     To assess the potential efficacy (in terms of objective response) of single agent copanlisib     in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the     relationship between efficacy and a potentially predictive biomarker   "
255905|NCT02364648|"     The purpose of this study is to examine the effect of mitochondria derived oxidative stress     on vascular function in patients with moderate to severe Chronic Kidney Disease.   "
255906|NCT02362646|"     The main purpose of this research is to determine whether injecting mesenchymal precursor     cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD)     is safe. MPCs are normally present in human bone marrow and have been shown to increase the     development of blood vessels and new heart muscle cells in the heart. In addition, this     research is being done to test whether injecting the MPCs into the heart is effective in     improving heart function.   "
255907|NCT02369523|"     The investigators plan to evaluate the length of time to discharge readiness between the     groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs.     periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). In     addition, the investigators will compare quadriceps strength recovery over time and     exploratory variables between the groups.   "
255908|NCT02402036|"     This is an exploratory biomarker study. Patients with metastatic colorectal cancer will     receive regorafenib, which is FDA approved in this setting, on day 1-21 of every consecutive     28 day cycle. Patients will be asked to undergo tumor biopsy at baseline and 2 weeks after     starting regorafenib. Peripheral blood samples will be collected at baseline 2 weeks after     starting regorafenib, after initiation of cycle 3, and every 4 weeks thereafter.   "
255909|NCT02358863|"     The purpose of this study is to determine whether molecular profile-directed therapy     (otherwise known as personalized treatment) can improve the effectiveness of standard     chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests     will be performed on a sample of tumor; based on the results of these tests, a patient will     be assigned to a chemotherapy treatment.   "
255910|NCT02363777|"     Design: Level I randomized prospective outcomes study comparing two groups of patients. One     group will receive bupivacaine and dilaudid thoracic epidural analgesia (PCA)     post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks     with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively     and a PCA.      Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients     presenting to the University of Minnesota Medical Center for elective open pancreatic     surgery.      Primary Objective: To determine if bilateral paravertebral catheters in patients with open     pancreatic procedures result in decreased pain compared to patients treated with thoracic     epidural for post-operative pain.      Secondary Objectives:        1. To determine whether the use of bilateral paravertebral catheters impacts the length of          ICU and hospital stay for patients, compared to a thoracic epidurals in patients          undergoing elective open pancreatic surgery.        2. To determine whether the use of ultrasound guided bilateral paravertebral catheters          leads to lower risk of complications, compared to use of a thoracic epidural in patients          undergoing open pancreatic surgery.   "
255912|NCT02358564|"     To better understand the relationship between gut barrier function and the symptomatology and     pathophysiology of IBS.   "
255946|NCT02283268|"     The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand     factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult     patients with hereditary severe von Willebrand disease (VWD).   "
255952|NCT02260570|"     The ability to regulate impulses enables us to plan for the future, to maintain focus in the     face of distractions (i.e. to encode memories), and to manage emotions. This self regulation     can be compromised in individuals who have a history of mild traumatic brain injury and     co-occurring disorders. In this study the investigators are using functional MRI scanning to     understand how memory and self regulation are expressed in the brains of people with a     history of mild traumatic brain injury. The investigators are also testing whether the     medication tolcapone may improve memory and self regulation.   "
255913|NCT02386605|"     Negative symptoms significantly interfere with daily functioning among individuals with     schizophrenia. They are strongly related to functional impairments [1] and contribute to the     poor community outcomes of Veterans with schizophrenia. Motivational negative symptoms     interfere with obtaining and maintaining employment [2], forming social relationships[3] and     living independently [4]. Developing treatments to effectively reduce negative symptoms is     important to achieve improvements in daily functioning. Recent empirical studies report that     psychosocial interventions for negative symptoms can have a moderate to large effect size on     community functioning and negative symptom severity. However, the treatments that have been     utilized so far are either cognitive-behavioral therapy interventions that require over a     year of weekly individual sessions and thus are very resource- and time-intensive, or they     are skills-training groups that do not address any of the cognitive and motivational aspects     of negative symptoms. Although group treatments are increasingly hailed as the gold standard     for schizophrenia, there is currently no group intervention explicitly for motivational     negative symptoms and functional deficits. Furthermore, treatment development and clinical     trials are increasingly reliant on neurophysiological measures of clinical severity and     treatment response and so far there are not identified negative symptom biomarkers.      The current CDA proposal will test a group-based treatment based on established motivational     enhancement (MI) techniques, augmented with cognitive-behavioral approaches, compared to an     active control group treatment, for improving motivational negative symptoms in Veterans with     schizophrenia. I will assess the efficacy of MI with measures from two outcome domains: 1)     negative symptoms (clinical ratings) and 2) functional outcomes (real-world improvements in     social, instrumental, and independent living). I will assess the relationship between these     outcomes and neurophysiological biomarkers (pupillometry and electroencephalography (EEG)).     Participants will be randomly assigned to the MI treatment or a control treatment for weekly     1-hour sessions for 12 weeks. The assessment battery will be administered at baseline, at     completion of treatment, and at 6-month follow-up. The investigators will enroll 60 Veterans     with schizophrenia that are low functioning and have high negative symptoms across the 4     years of the study.      This proposal is designed to examine group-based MI for reducing negative symptoms and     improving functioning in key domains (i.e., interpersonal, instrumental, and independent     living skills). Moreover, it will thoroughly investigate biomarkers of negative symptoms with     pupillometry and EEG. The development and evaluation of this recovery- oriented group MI     treatment for Veterans with disabling negative symptoms will yield results that can inform     larger treatment trials and neurophysiological measurement of negative symptoms in Veterans     with schizophrenia.   "
255915|NCT02369653|"     The purpose of this study is to compare the effect of a blood thinning drug called Apixaban     versus no administration of a blood thinning drug, in preventing blood clots in children with     leukemia or lymphoma. Patients must be receiving chemotherapy; including Pegylated     L-Asparaginase and have a central line (a catheter inserted for administration of medications     and blood sampling).   "
255953|NCT02257528|"     This phase II trial studies the side effects and how well nivolumab works in treating     patients with cervical cancer that has grown, come back, or spread to other places in the     body. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by     targeting certain cells.   "
255921|NCT02329587|"     This study is investigating whether combining noninvasive brain stimulation with behavior     therapy can help to improve outcomes for obsessive-compulsive disorder (OCD). Exposure and     response prevention (ERP) -- a specific type of behavior therapy -- is a first line treatment     for OCD. This study will test whether a form of noninvasive brain stimulation called     transcranial direct current stimulation (tDCS), can help ERP work better.   "
255928|NCT02334241|"     The aim of this study is to demonstrate, during a 12-week follow-up, a greater efficacy of     using Sorbact® dressing technology in addition to best local cares compared to best local     cares alone in the management of diabetic foot ulcers   "
255930|NCT02313428|"     This study is to observe the effect of application of topically administered oxygen on     healing rate, cost of care and rate of amputations in diabetic patients with chronic     wounds(s) . The proposed study is a pragmatic (comparative effectiveness research, CER)     study, in which the effectiveness of topical oxygen (100%) administered 4 days per week, for     16 weeks, for the treatment of diabetic wound(s) will be measure and compared with standard     of care (SoC) treatment. There will be a 2 patient groups (including a comparison group and a     treatment group) including: (1) Patients will only receive standard treatment (2) Patients     will receive standard treatment plus Topical Oxygen Therapy (TOT). All of the Topical Oxygen     Therapy will be provided in a home care setting or extended care facility. 140 patients will     be recruited.      There are two arms of the study. Arm 1 will enroll 100 subjects to assist the Ohio Department     of Medicaid (ODM) and to provide efficient and effective administration of the Medicaid     program. This is an observational and descriptive study that will seek to generate a     hypothesis. Due to the small sample size this study will primarily be a feasibility study     that will attempt to measure and evaluate differences in the relative costs of the     intervention of topical oxygen therapy on this population and subsequently compare outcomes     in areas such as overall health improvements and cost effectiveness. The patient population     will consist of Medicaid beneficiaries with chronic wounds and below who are enrolled in the     United Health Care Community Plan of Ohio (UHC).      Arm 2 of the study will enroll 40 additional patients that are Medicare and Dual     Medicare/Medicaid recipients with chronic wounds.   "
255934|NCT02324439|"     This is a phase 0/phase I feasibility trial to test the hypothesis that flaxseed     supplementation is an effective maintenance therapy for patients with ovarian cancer who are     in clinical remission following platinum-based regimens. The investigators further     hypothesize levels of estrogen metabolites and prostaglandin E2 in this patient population     will correlate with recurrence of disease, extent of tumor burden, invasion and metastasis.   "
255937|NCT02297139|"     The purpose of this study is to continue to provide dasatinib to patients that are currently     participating in another dasatinib trial that is ending and for which there is no other     option to provide dasatinib.   "
255954|NCT02253992|"     The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and     tolerable when they are given together.   "
256284|NCT03269071|"     This is a phase I study evaluating the feasibility, safety and tolerability of intrathecally     administered human Neural Stem Cells (hNSCs), at an escalating dose ranging from 0.7x10^6±10%     cells to 5.7x10^6±10% cells/kg of body weight, in patients affected by Progressive Multiple     Sclerosis   "
255940|NCT02293837|"     Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study     doctors think that giving medicines to affect the immune system soon after diabetes is     diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better     glucose control.      Researchers believe that tocilizumab could have some effect on the cells in the immune system     that are thought to be involved in the development of type 1 diabetes. This study will test     whether tocilizumab can help preserve or delay destruction of remaining beta cells in people     recently diagnosed type 1 diabetes.   "
255941|NCT02291289|"     This randomized, multi-center, active-controlled, open-label, parallel-group study will     investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line     mCRC. Participants with mCRC are eligible for entry and cannot have received any prior     chemotherapy in the metastatic setting. The entire study duration is anticipated to be     approximately 7.5 years.   "
255956|NCT02240472|"     Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its     use is reliable and reproducible. Today, it is clinical routine to not remove further lymph     nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s     reached by lymphatic flow from the breast) is free of tumor deposits. It is also routine to     leave remaining lymph nodes behind in case the sentinel node contains a minimal cluster of     tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in slightly     larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been shown that     a completion axillary clearance (removal of further lymph nodes from the arm pit) does not     contribute to a better survival. Data from a randomized study indicate that it seems safe to     omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes with tumor     deposits over 2 mm in size (macrometastasis). These studies have changed clinical practice in     many countries, however, it is still debated whether it is safe to omit axillary clearance in     the case of sentinel node macrometastasis due to under-recruitment in the aforementioned     study. The rationale for omitting extensive axillary surgery is the avoidance of     postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling.      The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2     sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more     than a maximum of 2.5% after 5 years.      This study is a prospective international randomized trial including 3500 patients.      Breast cancer patients without signs of axillary nodal involvement will be eligible for     sentinel node biopsy. Those who are found to have up to two sentinel node containing     macrometastasis will be informed about this trial Those wishing to participate will be     randomized to either undergo further axillary surgery (clearance) or not. Outcome measures     are breast cancer-specific survival, disease-free survival, axillary recurrence rate and     overall survival.   "
255958|NCT02236195|"     Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. This study is a     Phase 2 trial evaluating the efficacy of mocetinostat in patients that have advanced     urothelial carcinoma that has specific changes in tumor genes. Patients must have previously     received treatment with chemotherapy that included a platinum-containing agent such as     cisplatin. The study will enroll in stages, with 15 patients in the first stage. More     patients will be added to the study if enough patients having beneficial responses are     observed. Mocetinostat will be administered using oral capsules three times each week (eg,     Monday, Wednesday and Friday). The study is designed to evaluate whether the number of     patients responding to treatment is substantially higher than would be expected with other     available treatments.   "
255962|NCT02220374|"     Oesteoarthritis of the joints of the finger(s) is a common problem. The first-line treatment     involves pain killers taken either as tablets, gels, or patches. Secondly, some joints are     amenable to injections of steroids and anaesthetic agents. Finally, as a last resort, some     joints may be fused or replaced with prosthetic joints by Hand Surgeons. We are investigating     whether supportive taping of the painful finger joint reduces pain and improves function, and     whether this treatment could be used to substitute pain killers, injections or surgery. We     hypothesise that supportive finger tape may improve pain, improve the stability of the joint     and thereby improve day-to-day hand function too. We will investigate this through a     two-group parallel randomised controlled trial whereby one group will receive the treatment     taping and the other group will receive a theoretically placebo taping configuration. We will     measure pain daily, hand function and adverse events.   "
255966|NCT02217527|"     The study will assess a novel active drug vs. placebo on ability to reduce smoking and aid     cessation during a one-week practice quit period for each condition in smokers with a high     interest in quitting (i.e. crossover design). Medication effects on reducing craving,     withdrawal, and cognitive impairment will help assess the mechanism to support quit smoking     attempts.   "
255969|NCT02201407|"     This open--label, multicenter, national observational study will investigate the     effectiveness of standard of care treatment with peginterferon alfa-2a in participants with     chronic hepatitis B (CHB). Participants who have never received any hepatitis B virus (HBV)     treatment and participants previously treated with nucleos(t)ide analogs (NAs) are qualified     for enrollment. The observation period is 48 weeks (peginterferon alfa--2a standard of care     treatment) and for up to 24 weeks thereafter (72 weeks in total).   "
255972|NCT02201108|"     Primary Objective:      To assess the effect of teriflunomide in comparison to placebo on disease activity measured     by time to first clinical relapse after randomization in children and adolescents 10 to 17     years of age with relapsing forms of multiple sclerosis.      Secondary Objectives:        -  To assess the effect of teriflunomide in comparison to placebo on disease          activity/progression measured by brain MRI and on cognitive function.        -  To evaluate the safety and tolerability of teriflunomide in comparison to placebo.        -  To evaluate the pharmacokinetics (PK) of teriflunomide.   "
255974|NCT02282696|"     This study aims to validate the CARES, a needs assessment instrument which can be used to     inventorize cancer patients biopsychosocial distress and care needs.        -  QUANTITATIVE PART OF THE STUDY: Patients need to fill in a questionnaire package          containing questions about social-demographic and medical data, the CARES and convergent          measures: Karnofsky Performance Scale (KPS), Hospital Anxiety Depression Scale (HADS),          Social Support List (SSL), Maudsley Marital Questionnaire (MMQ), European Organisation          for Research and Treatment of Cancer Quality Of Life Core 30 (EORTC-QOL-C30), Distress          Thermometer (DT) and a Care Needs Questionnaire. One week after the first questionnaire          package participants have to fill in the CARES a second time and answer some questions          to evaluate the feasibility of the CARES.        -  QUALITATIVE PART OF THE STUDY: Participants from the quantitative part of the study and          other (ex-) cancer patients who not have to fulfill the criteria of age and cancer stage          can participate in a focus group interview. In these focus groups the content validity          and preferences on psychosocial screening in care are discussed.   "
255980|NCT02184221|"     Transcranial magnetic stimulation (TMS) is an effective alternative for pharmacotherapy in     major depressive disorder, but the effectiveness is not clear due to stimulated region,     frequency and intensity of magnet field. Standard TMS techniques only can stimulate     superficial cortical areas as the electric field decreases rapidly as a function of tissue     depth，while depression is also interconnected with deeper neuronal regions. Deep-brain     magnetic stimulation (DSM, or deep TMS, DTMS) allows stimulation of deeper cortical regions.     Previous research has demonstrated that alpha frequency (8-13 Hz) EEG activity may have     particular relevance to the response to antidepressants, and reduction of alpha frequency     (8-13 Hz) could lead to negative symptoms. It has been reported that both alpha frequency and     low-field magnetic stimulation could improve depressive symptoms.      The objective of this study is to compare the effectiveness of the two different parameters     of DMS in the treatment of major depressive disorder. The changes of brain derived     neurotropic factor (BDNF) are also investigated to make a relevant analysis of the     improvement of depressive symptoms.   "
255982|NCT02162823|"     SPP study includes incidence cases of pancreatic cancer in the Stockholm county region from     2007 to 2014. The purpose of SPP study is to estimate relative risk of pancreatic cancer in     relation to snuff dipping, overweight/obesity, individual food items, food groups, dietary     pattern and various nutrients; to estimate relative risk of pancreatic cancer in relation to     exposure to nitrosamines, either endogenously or exogenously; to estimate relative risk of     pancreatic cancer in relation to oral health and H.pylori infection and their interaction     with ABO blood type; to estimation relative risk of pancreatic cancer in relation to     hepatitis B or hepatitis C infection; to estimate relative risk of pancreatic cancer in     relation to some genetic polymorphisms, either functional or being suggested in GWAS study;     to estimate mutation profile in pancreatic cancer cases, and its correlation with     environmental exposures, and the impacts on survival periods in pancreatic cancer patients.      The MeSH name is Carcinoma, Pancreatic Ductal   "
255984|NCT02154425|"     The primary objectives of this study are to assess whether there is transfer of Certolizumab     Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing     regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate     the daily infant dose of maternal CZP.   "
255985|NCT02152891|"     Older adults living in subsidized housing report poorer health. Their age and low income make     it harder for them to use community services. Many older adults have heart disease and     diabetes, which lead to frequent emergency calls and hospital admissions. To decrease the     costs of treating heart disease and diabetes through emergency and hospitalization, improved     screening and health education is needed. Our program will take place in communal areas     within housing buildings of older adults and deliver a heart disease, diabetes, and falls     risk check-up with health education. This is expected to improve the health of older adults     leading to fewer emergency calls and hospital visits.   "
255986|NCT02166593|"     1. Target disease : Patients with combined dyslipidemia with adequately controlled LDL-C          but inadequately controlled triglyceride level by atorvastatin monotherapy        2. Study objective : The objective of this study is to demonstrate that Pravafenix Cap. is          clinically superior to atorvastatin by evaluating a percent change in Non-HDL-C in each          group after 8 weeks treatment with atorvastatin or Pravafenix Cap. (pravastatin          sodium/fenofibrate) in patients with adequately controlled LDL-C but inadequately          controlled triglyceride level by atorvastatin monotherapy in a multicenter, randomized,          double blind setting.        3. Phase and design : A multicenter, double blind, randomized, active controlled,          parallel-design, Phase 3 study        4. Duration of study : 12 months from the IRB approval date        5. Duration of administration : 4-week single blind run-in period plus 8-week double blind          treatment period   "
255990|NCT02154516|"     The purpose of this study is to assess the early and long term safety and efficacy of the     hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with     non-inflammatory arthritis.   "
255995|NCT03138252|"     Study Purpose: The purpose of this study is to determine the optimal method for induction of     labor in multiparous women who present with an unfavorable cervix.      Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in     place will result in more rapid labor courses, without increasing morbidity or increasing the     need for operative delivery.   "
255996|NCT02130973|"     This is a three-year study to evaluate the effect of sequential therapy of Forteo     (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm.   "
255999|NCT02125032|"     The aim of this study, is to determine whether treatment using transcranial low voltage     pulsed electromagnetic fields (T-PEMF) can reduce the symptoms patients with Parkinson's     Disease (PD) experience. The symptoms include movement, mentality and the nervous system in     general.      Furthermore the purpose of this study is to clarify whether a group of patients with PD, gain     a statistical improvement in their symptoms when treated with active T-PEMF, compared to a     group of patients with PD who receive placebo T-PEMF .   "
256001|NCT02194010|"     The purpose of this research study is to create and validate two patient reported outcome     (PRO) questionnaires. PRO questionnaires ask questions that help to measure disability in     patients with inherited neuropathies. These questionnaires ask questions about what     participants think disability is for themselves or others with inherited neuropathies. These     questionnaires are a useful tool when evaluating whether treatments are working in the day to     day life of an individual, although there are currently no questionnaires available     specifically for people who have Charcot Marie Tooth disease (CMT).   "
256285|NCT03270228|"     The investigators want to determine the incidence of malignant disease, type of malignant     disease and overall survival in patients diagnosed with NSP after VATS.   "
256005|NCT02096263|"     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'     Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and     6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK     Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.   "
256006|NCT02153710|"     This is a behavioral speech therapy trial for individuals who have suffered a stroke on the     left side of the brain and have difficulty speaking. The name of this disorder is called     aphasia. Individuals in this study will receive one of two treatments. The first is a     phonological (sound level) treatment and the second is a semantic (word level) treatment.     Individuals in both groups will receive 60 hours of therapy for free (2 hours/day, 5     days/week, 6 weeks).   "
256007|NCT02100163|"     The treatment of postoperative pain after severe trauma is poorly understood, and it can lead     to chronic pain, opiate drug addiction and elevated health care costs. The proposed project     will be a randomized controlled trial to evaluate an innovative methodology for delivering     clinical hypnosis (virtual reality hypnosis) for pain control as well as a more time-honored     delivery system that uses audio recordings. The goal will be to reduce postoperative pain in     a sample of patients hospitalized for the care of severe orthopedic trauma. This proposal     will test innovative and low-risk approaches to reducing postoperative trauma pain that are     designed to reduce pain, anxiety and other complications after surgery. The findings have the     potential not only to reduce pain and suffering in patients who have suffered severe     orthopedic trauma but could be applicable to the millions of people who have surgery every     year. Reducing addictive opiate-based medication and health care costs are both potential     outcomes from this project.   "
256012|NCT02075502|"     The primary aim of the study is to determine the effect of a community-based walking exercise     program with detailed training, monitoring, and coaching (TMC) exercise components enhanced     by community-based participatory research (CBPR) practices (TMC+) on the primary outcome of     peak walking time (PWT) in patients with peripheral artery disease (PAD).   "
256014|NCT02049632|"     Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method, and     several follow-up studies have shown that it is safe to refrain from completion axillary     clearance (axillary lymph node dissection, ALND) in SN-negative patients. SN biopsy alone     results in significantly less arm discomfort following the operation.      However, as a surprisingly low frequency of axillary relapse has been observed in patients     without any axillary intervention (neither SN biopsy nor axillary clearance), or without     completion ALND after a positive SN biopsy, the importance of ALND is being questioned, even     for patients with SN metastases. A large, randomized study (ISBCG23-1) was not able to show     any differences in 5-year disease-free survival between patients with SN micrometastases who     had undergone ALND and those who had not.      This Swedish multicenter study will include patients with SN micrometastases. These women     will not undergo ALND but will be registered in a study cohort. The patients will otherwise     be treated in accordance with the national guidelines and will be clinically followed every     year for five years, after 10 years and finally after 15 years. Hypothesis: To refrain from     axillary clearance in breast cancer patients with sentinel node micrometastases does not     impair survival.   "
256015|NCT02044276|"     The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to     pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.   "
256017|NCT02036177|"     The SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in     comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper:      Comparison of objective parameters - Pregnancy rate, perforation, expulsion and malposition     rates, changes in the endometrial thickness, rate of complications such as infection and     anemia and discontinuation rates after 1 year.      Comparison of Subjective parameters - pain during insertion, menstrual characteristics and     pain, bleeding in correlation to the bleeding pattern prior to insertion.      Physician opinion: ease of use in insertion and removal. Subject satisfaction.      It is expected that subjects using the copper IUB will demonstrate less safety events, equal     effectiveness and equal or improved menstrual bleeding and pain related profiles compared     with users of the T shaped copper IUD.   "
256019|NCT02045017|"     The primary purpose of the study is to determine the safety and efficacy and to generate PK     and biomarker data for the combination of Pomalidomide and low-dose Dexamethasone in patients     with relapsed or refractory multiple myeloma, with moderate or severe renal impairment.   "
256021|NCT02018926|"     Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a     hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate- or     high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the safety     of the study treatment. Safety assessments will include echocardiograms, electrocardiograms     and routine safety laboratory studies (hematology and serum chemistry). In addition, clinical     response to treatment will be monitored using bone marrow aspirates or biopsies, and other     routine methods.   "
256023|NCT02009826|"     Previous research has suggested central nervous system inflammatory activity to be critically     involved in disease development and progression in schizophrenia, with a complex interplay of     inflammatory mechanisms leading to the development of brain abnormalities and medical     symptoms related to schizophrenia. However, the mutual interactions of different inflammatory     pathways and their relation to disease course have not been sufficiently studied. This study     therefore aims to explore the interaction of neuroinflammatory mechanisms in patients with     schizophrenia and to assess whether the inflammatory activity in schizophrenia is     state-dependent and occurs mainly during psychotic episodes.   "
256029|NCT02011945|"     The purpose of this study is to find a dose of Nivolumab that can be safely added to     Dasatinib in patients with Chronic Myeloid Leukemia.   "
256033|NCT01988493|"     This is an open-label, integrated, Phase 1b/2 trial to determine the recommended Phase 2 dose     (RP2D) and to evaluate the efficacy, safety, and pharmacokinetic of MSC2156119J as first-line     treatment versus sorafenib in subjects with MET+, Barcelona Clinic Liver Cancer (BCLC) Stage     C, systemic treatment naive advanced hepatocellular carcinoma (HCC) and Child-Pugh class A     liver function.   "
256286|NCT03269591|"     Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled     trial in the Egyptian women   "
256035|NCT01974609|"     The purposes of this noninferiority randomized clinical trial are to:        1. determine whether the most commonly used commonly used non-narcotic analgesic (ibuprofen          600 mg + acetaminophen 325 mg) provides pain relief that is not unacceptably worse than          the most commonly prescribed narcotic containing analgesic (hydrocodone 5 mg. +          acetaminophen 325 mg, equivalent to Norco 5/325) in patients undergoing carpal tunnel          release.        2. Determine whether the following covariates affect pain level following surgery or          medication usage: gender, country (US/Canada), pre-operative CTS symptoms, site, workers          compensation status and employment status (employed/self-employed/unemployed-able to          work/unemployed-unable to work)   "
256036|NCT02113644|"     The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function     markers are already present in children of different weight categories and whether these are     age dependent. Also differences - and relationships - between vascular function measurements     and plasma biomarkers between lean and overweight/obese children will be compared.   "
256038|NCT01959269|"     The purpose of the study is to investigate the safety and effectiveness of Stivarga in     patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely     observational, only data from routine treatment are to be collected. The treatment and     treatment conditions are solely at discretion of the treating physician.   "
256061|NCT01857973|"     This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The     goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be     used in an even larger study outside of hospital.   "
256039|NCT01953016|"     Background:      - People with primary immune deficiency diseases (PIDD) have weak immune systems. This makes     it hard for their bodies to fight infection. The Immune Deficiency Foundation has a network     to collect data about people with PIDD. It is called the United States Immunodeficiency     Network. It will help doctors and scientists better understand these disorders. The goal is     to get medical data for everyone with these disorders in the U.S. and Canada. Data will be     stored in a registry. Researchers can use it to study if these disorders are increasing. They     can also learn how the disorders are diagnosed and treated.      Objectives:      - To collect data on people with primary immune deficiency disorders.      Eligibility:      - People who have a PIDD, or are a carrier for one.      Design:        -  Data can be added with no record of personal identity.        -  Data can be added with identity kept separate. This data will be linked to the registry          by a code number.        -  Data for the registry includes:        -  Family history        -  Disease treatment        -  Disease characteristics        -  Medical history        -  Laboratory data   "
256043|NCT02091544|"     Children and adolescents with overweight and obesity are predisposed to significant health     problems. It is known that childhood obesity can adversely affect almost every organ system,     and if left untreated, the major impact of childhood overweight is likely to be felt in the     next generation of adults.      The aim of  Kijk op overgewicht bij kinderen is to collect and follow-up longitudinal data     from a population of different degrees of children with overweight regarding etiological     factors, risk factors and early stages of chronic disease in different degrees of childhood     overweight.   "
256044|NCT01943526|"     The objectives of this study are to assess the long-term safety and impact on disease     activity and progression of natalizumab (Tysabri) in participants with relapsing remitting     multiple sclerosis (RRMS) in a clinical practice setting.   "
256045|NCT01946620|"     Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study.   "
256047|NCT01938378|"     To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring     serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs),     thromboembolic events (TEEs) and by measuring safety laboratory parameters.   "
256049|NCT01928394|"     ADDENDUM- PLEASE NOTE: AS OF JANUARY 2017, THIS STUDY IS ONLY RECRUITING PATEINTS WITH     BLADDER AND PANCREATIC CANCER. To investigate the safety and efficacy of Nivolumab as a     single agent or in combination with Ipilimumab in 6 tumor types - triple-negative breast     cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer     (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of Nivolumab with     Ipilimumab and Cobimetinib is also investigated in PC.   "
256051|NCT01922076|"     This phase I trial studies the side effects and the best dose of WEE1 inhibitor AZD1775 when     given together with local radiation therapy in treating patients with newly diagnosed diffuse     intrinsic pontine gliomas. WEE1 inhibitor AZD1775 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy     x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink     tumors. Giving WEE1 inhibitor AZD1775 with local radiation therapy may work better than local     radiation therapy alone in treating diffuse intrinsic pontine gliomas.   "
256053|NCT01913431|"     This is a multicenter, double blind, active-controlled, randomized, parallel group study to     demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for     patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48     days.   "
256054|NCT01906255|"     This is an observational nested case control study among pre-exposure prophylaxis (PrEP)     observational or clinical studies. The study will assess level of adherence as measured by     drug level and its relationship to renal and bone adverse events, risk of seroconversion, and     resistance development in subjects taking emtricitabine (FTC)/tenofovir disoproxil fumarate     (TDF) (Truvada®) for PrEP.      In the protocols of the parent PrEP observational or clinical studies, participants will have     follow-up visits on average every 3 months for evaluation of adherence, HIV-1 status, renal     and bone adverse events, and seroconversion. Adherence will be determined by the specific     FTC/TDF drug level measurement(s) outlined in the parent protocol.      There are two case definitions: a) One-hundred-fifty subjects who seroconvert (become HIV-1     positive) and b) any subjects who either develop a protocol-defined renal adverse event     (stratified by Division of AIDS [DAIDS] grading) or have a skeletal adverse event (any     fracture) while taking FTC/TDF for PrEP.      Among the estimated 7,000 subjects from Truvada for PrEP observational and clinical studies     all cases, defined as subjects who seroconvert and/or develop either renal or skeletal     adverse events, will be identified. Randomly chosen controls on Truvada will be selected in a     3:1 ratio, from the same site, with a similar treatment duration.   "
256055|NCT01902472|"     This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and     following seroconversion, assess the frequency of HIV-1 screening and screening method(s)     used for evaluation of seroconverters, and collect information regarding whether the     seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time     of seroconversion.   "
256056|NCT01896999|"     This randomized phase I/II trial studies the side effects and best dose of ipilimumab and     nivolumab when given together with brentuximab vedotin in treating patients with Hodgkin     lymphoma that has returned after a period of improvement or has not responded to previous     treatment. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the     ability of cancer cells to grow and spread. Brentuximab vedotin is a combining monoclonal     antibody with an anticancer drug that binds to a protein on the surface of lymphoma cells     called cluster of differentiation (CD)30 and may kill the cells. It is not know whether     giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer     cells.   "
256058|NCT01878721|"     The purpose of this study is to evaluate the value of positron emission tomography/computed     tomography in various inflammatory conditions caused by bacterial infection or vasculitis.     Glucose analog FDG is sensitive to detect inflammation foci but we hypothesize that other     imaging agents such as PK11195 and Ga-citrate may have added value in certain applications.   "
256059|NCT01864083|"     This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate     how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or     PEM can accurately measure your response to chemotherapy.   "
256067|NCT01838226|"     Prevention of cardiovascular disease is a primary focus of the Secretary's New Models of Care     Transformational Initiative. However, prevention has been hard to accomplish. The VA is     committed to using group visits to address a wide array of primary care problems. Coaching is     a method to help Veterans set and reach health goals by helping them overcome barriers to     behavior change. Coaching can be performed one-on-one or in groups. This study will test the     effectiveness of a group prevention coaching (GPC) intervention in improving cardiovascular     risk. GPCs will focus on changing a behavior of the patient's choice that is likely to lead     to improvements in heart disease risk. The coach will adopt a problem-solving approach to     helping Veterans make these improvements. The primary outcome will be change in 10-year risk     of major cardiac event; the investigators will also assess improvements in food choice,     physical activity and weight.   "
256068|NCT01835158|"     This randomized phase II trial studies how well cabozantinib-s-malate works compared to     sunitinib malate in treating patients with previously untreated kidney cancer that has spread     from where it started to nearby tissue or lymph nodes or to other places in the body.     Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate     is more effective than sunitinib malate in treating patients with kidney cancer.   "
256069|NCT01836276|"     The purpose of this study is to describe the differences in quitting smoking between African     Americans (AA) and White smokers treated with varenicline.   "
256070|NCT01824433|"     Women are more prone to depression at certain points of the life cycle, although the     etiologic and therapeutic implications remain largely unknown1,2. It is reported that pre-     and postmenopausal women have a significant difference in response to some antidepressants,     within a large clinical trial data set3, 4. A growing number of researches indicate that a     woman's hormonal status may influence response to different forms of antidepressant     medication. Specifically, younger women appeared to respond better to monoamine oxidase     inhibitors (MAOIs) and selective serotonin reuptake inhibitor (SSRIs), whereas men and older     women have tended to have relatively better responses to tricyclic antidepressants (TCAs)     1-5. One difference between these classes of antidepressants is that the SSRIs are strongly     serotoninergic, whereas TCAs have predominantly noradrenergic effects. One pooled analysis 6     suggests that older women (age ≥ 50) tend to respond poorer to SSRI, while this phenomenen     was not observed with venlafaxine.      The antidepressive mechanism of venlafaxine that has both noradrenergic and serotonergic     effects is superior to SSRIs. As a noradrenergic and serotonergic antidepressant,     venlafaxinee has been demonstrated of significant advantages in response and remission rates     compared with various SSRIs. As mentioned above, older women tend to have relatively better     responses to TCAs which is predominantly noradrenergic antidepressant. Postmenopausal women     with depression also would be predicted to respond better to an SSRI if administered along     with hormone replacement therapy 6. This could be critical to understanding age difference in     antidepressant responses across the life cycle because circulating estrogen levels may     modulate central serotoninergic pathways. Therefore, it is presumed that antidepressants     which enhance both serotonergic and noradrenergic neurotransmission, as venlafaxine, may be     more effective than SSRIs for postmenopausal women with major depressive disorder.   "
256075|NCT01801007|"     The purpose of this study is to evaluate the safety and effectiveness of the MicroVention     Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked     intracranial aneurysms.   "
256078|NCT01792115|"     Background:        -  Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver          cells. It is associated with obesity, high blood pressure, high cholesterol, and          diabetes. Some people with NAFLD only have excess fat in the liver. However, other          people may develop a worse form of NAFLD with liver injury and scarring. This form,          called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer,          and death. Not much is known about why some people develop NASH and others do not.        -  Lifestyle changes such as diet, exercise, and weight loss can decrease the liver damage          in NAFLD. Some studies show that vitamin E can also help treat NAFLD. The dose of          vitamin E used in these studies is almost 40 times the recommended amount of vitamin E          intake from food. It is unclear whether a lower dose could achieve the same effect.          Researchers also want to study how vitamin E works at different doses to treat NAFLD.      Objectives:        -  To find out the most effective dose of vitamin E to treat NAFLD.        -  To gain a better understanding of how NAFLD and NASH develop, and predict who will          respond to treatment.      Eligibility:      - Individuals at least 18 years of age with suggestion of non-alcoholic fatty liver disease.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  For the first 12 weeks of the study, participants will meet with a nutritionist. They          will have personalized diet and exercise plans. Treatment will be monitored with diaries          and questionnaires to fill out at home. Participants will also wear a pedometer to          measure physical activity.        -  After the 12-week period, participants will have a full physical examination with the          following tests:        -  Blood tests        -  Glucose tolerance tests        -  Imaging studies (DEXA scan and magnetic resonance imaging)        -  Liver and fatty tissue biopsy        -  Two weeks after the tests, participants will start vitamin E treatment. They will take          up to two pills a day, taken with fat-containing foods.        -  4 weeks after starting treatment they will have a repeat full evaluation with imaging          tests, blood work, and liver and fat biopsies.        -  Participants who are taking vitamin E will take it for up to 120 weeks. They will have          monitoring visits every 8 to 12 weeks. At the end of 120 weeks, they will have another          full evaluation, with imaging tests, blood work, and liver and fat biopsies.   "
256081|NCT01836484|"     This is a prospective diagnostic performance study which compares three new imaging methods     with the current standard imaging method for the diagnosis of metastatic lymph nodes.   "
256082|NCT01782339|"     The treatment of germ cell tumours is considered to be one of the major successes in the area     of cytotoxic chemotherapy. Even in patients who relapse after first line therapy, a durable     remission rate of between 25% and 60% has been seen using further chemotherapy. In 1999,     researchers at St Bartholomew's Hospital developed the GAMEC protocol (combination     chemotherapy with filgrastim, actinomycin D, methotrexate, etoposide, cisplatin). Results     from this study showed that 50% of patients with relapsed testicular cancer could be cured     using this treatment. When we reviewed the individual patients it was clear that older     patients (>35yrs) or patients with a raised Lactate Dehydrogenase (a blood test that monitors     cancer activity), did not do as well. In addition, patients whose original tumour started in     their chest (mediastinal germ cell tumour) have tended to do badly if they relapse. We have     been developing a study for patients who fulfil at least one of these criteria. The GAMIO     study (filgrastim, actinomycin D, methotrexate, irinotecan, oxaliplatin) has recently closed     due to problems with high levels of toxicity from the irinotecan. GAMMA is a new study that     will use paclitaxel instead of irinotecan and oxaliplatin instead of cisplatin. We expect     that this treatment with oxaliplatin will be less damaging to the kidneys than cisplatin.     Both oxaliplatin and paclitaxel and oxaliplatin and irinotecan have similar activity in     relapsed patients in the phase II setting. We hope to improve on our previous results with     this substitution and see if this will lead to an improvement in the cure rate of relapsed     germ cell tumours with poor prognosis and reduce the side effects compared to our standard     treatment. In addition, we do not expect any hearing damage and the treatment requires a     shorter hospital stay.   "
256084|NCT01775644|"     This observational multicenter study will evaluate the differences in progression-free     survival defined in specific subgroups of participants with metastatic colorectal cancer     receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be     assessed.   "
256086|NCT01776905|"     The objective of this clinical trial is to determine whether a Photoacoustic flow cytometry     (PAFC)-based prototype device can detect circulating tumor cells (CTCs) in the blood of     melanoma patients in vivo, in real time, and do so at detection limits at least one order of     magnitude below the detection limits of currently existing ex vivo methods.   "
256090|NCT01775436|"     Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting     co-morbidities to decrease suffering and increase quality of life (QOL). Left without advance     care planning (ACP) for end-of-life decision, miscommunication and disagreements may result     in families being charged with neglect or court battles over treatment choices, unmet care or     delivery of unnecessary or unwanted care, and non-relative caregivers being dismissed (e.g.     gay partners). We hope to increase families' understandings of their family member's wishes     for end-of-life care to decrease conflict through the FAmily-CEntered Advance (FACE) Care     Planning intervention. We will also study communication, quality of life, and spiritual     struggle. Families will be randomized into either the Control (N=96 families) or the FACE     Intervention (n=192 dyads). FACE families will meet with a trained/certified researcher for     two 60-minute sessions scheduled one week apart: Session 1: The Respecting Choices     Interview®; and Session 2: Completion of The Five Wishes©. Control families will also meet     with a researcher for two 60-minute sessions scheduled one week apart: Session 1:     Developmental History; and Session 2: Nutrition and Exercise. Questionnaires will be     administered five times, Baseline and at 3, 6, 12 and 18 month post-intervention, for an     average of 2 years.      AIM 1. To determine the efficacy of FACE on congruence in treatment preferences between PLWA     and their surrogates over time, and the effect of the pattern of congruence development     trajectory on healthcare utilization (i.e., distal outcomes: number of hospitalizations,     dialysis, ER visits).      Hypothesis A: Development of congruence may not be homogeneous and FACE may influence the     pattern of congruence development.      Hypothesis B: Different patterns of congruence development may have different effects on     health care utilization.      Hypothesis C: Compared to Controls, FACE participants will better maintain congruence over     time.      AIM 2. To determine the efficacy of FACE on key components of QOL for PLWA. Hypothesis: FACE     participants will increase or better maintain psychosocial QOL compared to Controls.      AIM 3. To minimize health disparities in ACP between Blacks and non Blacks and identify     factors associated with disparities.      Hypothesis: Blacks in the FACE intervention will complete advance directives at a rate     comparable to non Blacks, and at significantly greater rates compared to Controls.   "
256092|NCT01753908|"     This randomized pilot trial studies broccoli sprout extract in treating patients with breast     cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of     certain cancers. Studying samples of tissue from patients receiving broccoli sprout extract     may help determine if it can enter breast tumor cells and how it affects certain biomarkers.   "
256094|NCT01744171|"     This phase I trial studies the side effects and best dose of vaccine therapy in treating     patients with stage III-IV melanoma that has spread to other places in the body and usually     cannot be cured or controlled with treatment (advanced). Vaccines made from peptides or     antigens may help the body build an effective immune response to kill tumor cells.   "
256107|NCT01687413|"     This clinical trial studies the intensity of adjuvant (helper) therapy required in p16     positive oropharynx cancer patients, who have had all known disease removed surgically by a     minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients     can consent to participate in either the randomized (physician chooses radiotherapy arm or     radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or     radiotherapy & cisplatin arm) pathways. After the surgery, receive either radiation alone, or     radiation and weekly cis-platinum during therapy. Patients are then followed for cancer,     functional and quality of life outcomes.   "
256096|NCT01736293|"     Background:      - The ABCA4 gene contains a blueprint for the ABCA4 protein. When this protein is absent or     faulty (such as in Stargardt s disease), waste material from dead cells collects in the eye.     The waste material may cause other cells in the eye to die. This can lead to the loss of     vision. Researchers want to look at blood and skin samples from people with ABCA4 gene     mutations to study related eye diseases.      Objectives:      - To study eye diseases that are related to mutations in the ABCA4 gene.      Eligibility:      - Individuals at least 12 years of age who have ABCA4 gene mutations.      Design:        -  The study requires seven visits to the National Eye Institute clinic over 5 years. In          the first year, there will be three visits. After the first year, participants will have          one visit a year for 4 more years.        -  Participants will be screened with a physical exam, full eye exam, and medical history.          The eye exam will check eye pressure, light and color sensitivity, and retina function.        -  Participants will provide a blood sample and a skin tissue sample for study.        -  No treatment will be provided as part of this study.   "
256100|NCT01724476|"     The investigators propose to conduct a randomized Sequential Parallel Design for Double-Blind     Phase fixed dose, 4-month trial of folate plus B12 as add-on therapy in 200 Ethiopian     subjects with schizophrenia with stable residual positive or negative symptoms.   "
256101|NCT02272816|"     Metastatic seminoma is a relatively uncommon disease. The most widely used treatment for this     disease is chemotherapy with the drugs, cisplatin and etoposide with or without the addition     of bleomycin. This treatment combination has shown good survival rates however it is toxic     usually requires an inpatient visit with administration over three days and can cause     significant nausea, malaise, alopecia, risk of kidney damage, hypertension and high tone     hearing loss.      Previous studies have demonstrated that carboplatin is also effective in treating this     disease type. Progression free survival is less than that seen with the combination     chemotherapy yet overall survival is the same between the two treatments because of the     effectiveness of second line salvage chemotherapy. Single agent carboplatin is a less toxic     treatment and more convenient as it is given as a day case.      A recent study run by the Orchid Clinical Trials Group looked at whether carboplatin (AUC10)     is not only associated with fewer side effects, but more convenient to give as an outpatient     treatment and that it is comparable in terms of cure rate. 20 patients were recruited to the     trial and the results were encouraging with only one relapsed patient. This patient went on     to be cured by conventional treatment. The positive outcome of the AUC10 trial has led to the     design of this new multi centre study.      This open labeled, multi centre trial will recruit up to 50 patients with good prognosis     metastatic seminoma. All patients will receive three cycles of carboplatin AUC 10. Patients     will be followed up for survival and closely monitored for side effects during treatment.     Patients will have a PET-CT scan before they start treatment and after the completion of     their first cycle. We hope that this scan will help us to identify which patients have     responded metabolically and therefore not requiring an extra cycle of chemotherapy.   "
256104|NCT01707394|"     CV185118 is a single dose Apixaban PK/PD study in pediatric subjects. The objective of this     study is primarily to study the PK/PD of Apixaban in pediatric subjects at risk for     thrombosis   "
256126|NCT01545622|"     The purpose of this study is to analyze the findings of 30 surgeons and 30 nuclear     radiologists of 61 individual thyroid scans. The goal is to determine if surgeons are more     prone to making a definitive diagnosis based on a given scan than a nuclear radiologist.     Accuracy of localization of the two groups will be analyzed. A secure website has been     designed to which the physician will be able to login and view and rate the quality of each     image and make a localizing diagnosis. Once they are finished, they will not be able to make     any more changes, and their responses will be compared to the responses of their colleagues.     The results will be analyzed to find if there is a significant variation in the ratings     between the surgeons and the nuclear radiologists as to the quality, location, and number of     parathyroid glands, if any, on the scans.   "
256106|NCT01688856|"     Impaired arm and hand function is one of the most disabling and most common consequences of     stroke. The Investigators have developed Contralaterally Controlled Functional Electrical     Stimulation (CCFES), an innovative neuromuscular electrical stimulation (NMES) treatment for     improving the recovery of hand function after stroke. The purpose of this study is to     maximize the treatment effect of CCFES by adding stimulated elbow extension. The specific     aims and hypotheses are as follows:      AIM 1: Estimate the effect of Arm+Hand CCFES on upper limb motor impairment and activity     limitation.      Hypothesis 1: Stroke survivors treated with Arm+Hand CCFES have better outcomes on upper limb     impairment and activity limitation measures than those treated with dose-matched Arm+Hand     Cyclic NMES.      AIM 2: Estimate the effect of adding stimulated elbow extension to Hand CCFES.      Hypothesis 2: Stroke survivors treated with Arm+Hand CCFES will have greater reductions in     upper limb impairment and activity limitation than those treated with Hand CCFES.      AIM 3: Describe the relationship between treatment effect and time elapsed between stroke     onset and start of treatment.      Hypothesis 3: Patients who start Arm+Hand CCFES sooner after their stroke achieve better     outcomes.   "
256109|NCT01657942|"     The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential     to be an effective non-invasive treatment for low to intermediate risk, organ-confined     prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by     measuring treatment-related safety and initial effectiveness parameters in the ExAblate     MRgFUS treated patients, as described above.   "
256110|NCT01652157|"     This is a long-term study in cystic fibrosis patients who are participating in the Cystic     Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder     called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at     their regular clinical care visits over a 10-year period and approached if they develop     symptoms of fibrosing colonopathy for collection and use of further detailed information.   "
256111|NCT01643655|"     The purpose of this study is to investigate the efficacy and safety of autologous     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with     avascular necrosis of the femoral head.   "
256112|NCT01642251|"     This randomized phase I/II trial studies the side effects and best dose of veliparib when     given together with or without cisplatin and etoposide and to see how well they work in     treating patients with extensive stage small cell lung cancer or large cell neuroendocrine     non-small cell lung cancer that has spread to other parts of the body. Drugs used in     chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving cisplatin and etoposide with or without veliparib may work     better in treating patients with extensive stage small cell lung cancer or metastatic large     cell neuroendocrine non-small cell lung cancer.   "
256115|NCT01622933|"     This clinical trial is to determine if the addition of a standard of care drug,     interferon-alfa 2b (IFN), with an investigation vaccine will have any affect on the immune     system and/or your cancer. The investigational vaccine will be made with genes that are     specific to melanoma and will be given intradermally (i.d.) every two weeks for a total of 3     vaccines.      After the vaccines, subjects will be randomized to either receive a boost of high dose IFN or     no boost. IFN will be administered intravenously (into a vein) for 5 consecutive days (Monday     through Friday) every week for 4 weeks. Administration will begin approximately 30 days (± 7     days) after the 3rd vaccine. The first dose of IFNα2b may begin within 10 business days of     randomization. All subsequent procedure dates for Group A will be based on the date of the     first dose of IFNα2b.   "
256117|NCT01617096|"     This is a double-blind, randomised, placebo-controlled study to assess the safety and     efficacy of a silicone elastomer vaginal matrix ring.   "
256119|NCT01593254|"     The purpose of this study is to test the hypothesis that patients with CML who have not     achieved optimal response after 3 months of treatment with imatinib will have a better     response by switching to dasatinib compared to staying on their original imatinib regimen.   "
256307|NCT03270956|"     Therapeutic intervention with NKA is intended to delay the need for renal replacement therapy     (dialysis or transplant) which, based on the current standard of care, is inevitable for     patients with end stage CKD. The purpose of the present study is to assess the safety and     efficacy of up to 2 injections of NKA given 3 months (+12 weeks) apart.   "
256121|NCT01572480|"     Background:        -  Multiple myeloma is a blood cancer that affects the plasma cells. These cells help          produce antibodies and fight infection. Smoldering multiple myeloma (SMM) is a related          condition that may develop into multiple myeloma. The current standard of care for SMM          is close follow-up without treatment until multiple myeloma develops. However,          researchers are studying possible treatments for SMM itself. One possible treatment          involves a combination of cancer treatment drugs.        -  Lenalidomide is a drug that may help reduce or prevent the growth of cancer cells.          Dexamethasone is a steroid that is often given with other anti-cancer drugs. These two          drugs are an approved treatment for multiple myeloma that has not responded to at least          one other treatment. Carfilzomib is an experimental drug that has been effective in          treating multiple myeloma. Researchers want to combine these three drugs to see if they          are a safe and effective treatment for SMM.      Objectives:      - To see if carfilzomib, lenalidomide, and dexamethasone are a safe and effective treatment     for smoldering multiple myeloma.      Eligibility:      - Individuals at least 18 years of age who have SMM that is likely to progress to multiple     myeloma.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood and urine tests, and baseline bone marrow scans. Bone marrow samples will          also be collected.        -  Participants will have eight 28-day cycles of treatment with the three study drugs. The          drugs will be given as tablets or as infusions. Treatment will be monitored with          frequent blood tests and study visits.        -  After the first four cycles, participants who are eligible for a stem cell transplant          will have their stem cells collected and stored for future use.        -  At the end of eight cycles, participants whose disease has not progressed will have up          to 12 more cycles of treatment with lenalidomide tablets alone.   "
256122|NCT01571505|"     Oral polio and rotavirus vaccines are significantly less effective in children living in the     developing world. Tropical enteropathy, which is associated with intestinal inflammation,     decreased absorption and increased permeability, may contribute substantially to oral vaccine     failure in developing country settings. Other possible causes of oral vaccine     underperformance include malnutrition, interference with maternal or breast milk antibodies,     changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is     to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus     vaccines is associated with the presence of tropical enteropathy.   "
256208|NCT00876369|"     The objective of this study is to perform an exploratory analysis to determine if a possible     relationship between vitamin D and chronic urticaria and/or angioedema exists. The study     hypothesis is that vitamin D deficiency is associated with chronic urticaria and/or     angioedema.   "
256127|NCT01539499|"     The goal of this study is to help better determine the complication rates for endocrine     surgery across the nation for both benign and malignant disease. It is our hypothesis that     the complication rates are low overall and that malignant disease results in a higher     complication rate than benign disease. This study will do a database review from all     University HealthSystem Consortium (UHC).   "
256581|NCT02597036|"     The main purpose of this study is to evaluate the safety of the study drug known as LY3127804     given as monotherapy and in combination with Ramucirumab for participants with advanced or     metastatic solid tumors. The study will also include a safety exploration for the combination     of LY3127804 plus ramucirumab and paclitaxel   "
256130|NCT01524822|"     Background:      - Repeated exposure to explosions may lead to changes in the way that people think or feel.     Breachers (people trained to use explosives to get into buildings) are exposed to repeated     blasts as part of their job. Researchers want to study how they might be affected by blast     exposure. Breachers will be compared with other groups who have different levels of exposure     to repeated blasts. Information will also be obtained from spouses or close companions.      Objectives:      - To study the effects of repeated exposure to low-level blasts on thinking, memory,     behavior, and brain function.      Eligibility:        -  Experienced military and civilian breachers, experienced active duty artillery          operators, and active duty military without frequent blast exposure, 18 and 60 years of          age.        -  Spouses or close companions of these individuals.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected and a urine pregnancy test will be required of participants (not          companions) before MRI scanning.        -  Participants will spend up to 5-days as a NIH clinic outpatient, with about 6 hours of          tests each day. Tests will include the following:        -  Medical and professional history, with questions about exposures to blasts        -  Tests of thinking, memory, and concentration        -  Balance tests        -  Hearing tests        -  Imaging studies, such as magnetic resonance imaging, to look at the brain        -  Overnight sleep study to monitor brain waves        -  Blood samples        -  Participants will return 1 year later for a 3-day followup visit. Some of the tests from          before will be repeated. A spouse or close companion (if available) will be asked to          complete questionnaires or have a telephone interview.   "
256131|NCT01506219|"     Introduction:      Elderly with multiple illnesses represent the fastest growing sector of society and make     increasing demands on all sectors of the health care system, particularly in community     rehabilitation units due to shorter time of stay in acute care units and hospitals. The aim     of this study is to investigate the effect of geriatrician-performed comprehensive geriatric     care (CGC) in older people referred to a community rehabilitation unit.      Methods:      The study is a prospective randomized controlled trial. Settings: two community care     rehabilitation units in Aarhus Municipality, Denmark. Inclusion: persons aged 65 and older     from home or hospital. Exclusion: persons who received palliative care or had been assessed     by a geriatrician during the past month. Intervention: medical history, physical examination,     blood tests, medication adjustment and related treatments performed by a geriatrician.     Control: usual care in a community rehabilitation unit. Number of hospital admissions and     emergency department (ED) visits (primary outcome), number of GP contacts, activities of     daily living, physical and cognitive functioning, quality of life, institutionalization,     medication status, and mortality were assessed at day 30 and 90 after arrival at the     rehabilitation unit.      Preliminary results:      The outpatient CGC model was developed, implemented and compared with usual care in a     pragmatic RCT. We hypothesized that this new model of care will reduce the number of hospital     admissions and Emergency Department visits without increase of contacts to general     practitioners, and without decline in activities of daily living or worsening of quality of     life.   "
256132|NCT01494805|"     The study will involve approximately 40 subjects aged 55 or above who have exudative     age-related macular degeneration (wet AMD). Patients will be randomized to receive one of two     doses of rAAV.sFlt-1 or assigned to the control group.   "
256133|NCT01489410|"     Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used     method for the palliative or curative treatment of these lesions. These attempts are being     made to make these patients a better candidate for liver transplant or to provide palliation     for their condition.   "
256134|NCT01485614|"     The purpose of the study is to assess the safety of the addition of sitagliptin, and its     effect on hemoglobin A1c (A1C) in pediatric participants 10-17 years of age with type 2     diabetes mellitus (T2DM) with inadequate glycemic control. The primary hypothesis for this     study is that sitagliptin reduces A1C more than placebo after 20 weeks of treatment.   "
256135|NCT01492504|"     The primary purpose of this study is to determine whether the hepatitis C virus continues to     remain unable to be detected in subjects who were previously treated with Asunaprevir     (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.   "
256142|NCT01460160|"     The purpose of this study is to determine whether Dasatinib when added to standard     chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome     positive acute lymphoblastic leukemia   "
256143|NCT01459302|"     The investigators laboratory has been studying families with a history of ALS for more than     25 years and is continuing to use new ways to understand how genes may play a role in ALS,     motor neuron disease and other neuromuscular disorders.      The purpose of this study is to identify additional genes that may cause or put a person at     risk for either familial ALS (meaning 2 or more people in a family who have had ALS),     sporadic ALS, or other forms of motor neuron disease in the hopes of improving diagnosis and     treatment. As new genes are found that may be linked to ALS in families or individuals, the     investigators can then further study how that gene may be contributing to the disease by     studying it down to the protein and molecular level. This includes all forms of ALS, motor     neuron disease and ALS with fronto-temporal dementia(ALS/FTD). We also continue to study     other forms of neuromuscular disease such as Miyoshi myopathy, FSH dystrophy and other forms     of muscular dystrophy by looking at the genes that may be associated with them.      There have been a number of genes identified that are associated both familial and sporadic     ALS, with the SOD1, C9orf72, and FUS genes explaining the majority of the cases. However, for     about 30% of families with FALS, the gene(s) are still unknown.      The investigators also will continue to work with families already identified to carry one of     the known genes associated with ALS.   "
256150|NCT01445483|"     Background:        -  There are no standardized sets of tests to measure changes in neuropsychological          functioning in patients treated for brain metastasis (cancer that has spread beyond the          original site to the brain).        -  Neuropsychological function has an important effect on quality of life and should be          included when determining treatment options.      Objectives:        -  To find out if there is a change in patients cognitive (thinking) and daily functioning          after standard radiation treatment for brain metastasis that can be measured with tests.        -  To see if any changes on these tests are related to patients response to radiation          therapy.      Eligibility:      - Patients 18 years of age or older who have cancer that has spread to the brain.      Design:        -  Patients receive a 2-week course of radiation therapy to the brain, given daily 5 days a          week. Some patients may require stereotactic radiosurgery (an additional boost of          radiation therapy to specific sites of brain metastasis).        -  Patients have the following evaluations before and after treatment to determine changes          in cognition and functioning:        -  Neuropsychological testing to measure cognitive (thinking) abilities like memory,          attention, processing speed, and reading, and fine motor skills.        -  Questionnaires to assess quality of life and daily living skills.        -  Patients have MRI scans and blood and urine tests.        -  At the completion of radiation treatment, patients return to the clinic for follow-up          visits at 1, 2, 4, 6, 9 and 12 months for blood and urine tests, physical examination,          MRI of the brain, neuropsychological testing and assessments of quality of life and          daily living skills.   "
256153|NCT01419327|"     This study is a regulatory post marketing surveillance in Japan, and it is a local     prospective and observational study of patients in hemodialysis who received Fosrenol for     hyperphosphatemia. The objective of this study is to assess safety and efficacy of using     Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.   "
256154|NCT01458626|"     Although treatment guidelines manifest that antidepressant response usually appear with a     delay of several weeks and suggest that treatment should be changed if a partial response has     not occurred after 4~6 week, these beliefs are no longer held by experts, and a new concept     is raised that the first 2 weeks of treatment may be a useful strategy for improving the     management of depression. New evidence indicates that early treatment response can be     predicted with high sensitivity after 2 weeks of treatment in patients with major depressive     disorder (MDD).      Early improvement not only predicted response or remission, but also that lack of improvement     was associated with little chance of response if the treatment strategy remained unchanged.     The criterion of a 20% score reduction has been chosen as an early indicator of improvement     because it can be reliably measured in clinical trials and translates into a clinically     relevant change in the severity of depressive symptoms.      Antidepressants that enhance both serotonergic and noradrenergic neurotransmission may be     more effective than selective serotonin reuptake inhibitors (SSRIs) for acute-phase therapy     of major depressive disorder. As a noradrenergic and specific serotonergic antidepressant,     the antidepressive mechanism of mirtazapine is quite superior to SSRI and in particular has     been suggested to have a faster onset of action than SSRIs in MDD patients.      The aim of this study is to provide physicians with further information regarding early     improvement and the effectiveness of mirtazapine combined with a SSRI antidepressant therapy     in nonresponders.   "
256156|NCT01870375|"     Neurobehavioral function and quality of life are compromised in many patients with     mucopolysaccharidosis (MPS) disorders. The long-term goals of this research are to: 1) more     accurately inform patients/parents regarding potential neurobehavioral outcomes; 2) develop     sensitive measures of disease progression and central nervous system (CNS) treatment outcome;     and 3) help clinical researchers develop direct treatments for specific brain     structures/functions. The investigators hypothesize that specific and localized neuroimaging     and neuropsychological findings and their relationship will be distinct for each MPS     disorder. It is further hypothesized that without treatment, functions will decline and     structure will change over time in a predictable fashion, and will be related to locus of     abnormality and stage of disease.   "
256582|NCT02593994|"     The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent     compared to other (drug eluting stents) DES.   "
256157|NCT01403142|"     Cardiac allograft vasculopathy (CAV) is a unique form of accelerated plaque formation seen in     the coronary arteries of patients who have received heart transplantation. It is a major     cause of morbidity and mortality in patients after heart transplant. Little progress has been     made in characterizing this disease process, with more sophisticated imaging allowing for     more detailed analysis of CAV, superior stratification of transplant recipients is possible     and earlier interventions can be performed if necessary to prevent mortality and graft loss.      Optical Coherence Tomography (OCT) is a novel imaging modality with much higher resolution     then Intra-Vascular Ultrasound (IVUS). This study will involve examining patients post-heart     transplant using this high-resolution imaging modality. It is currently the standard care for     patients post-heart transplant to receive annual coronary angiograms with close follow up.     Patients will be imaged using OCT at the time of their routine annual angiogram, and will be     re-imaged one year later at the time of the next annual angiogram or earlier if clinically     indicated. The study goal is to better characterize CAV in vivo with OCT imaging and to try     to identify patterns of the disease, including intra-coronary risk assessment.   "
256160|NCT01390064|"     Objective - Determine the safety and tolerability of a peptide mimotope-based vaccine upon     immunization of breast cancer subjects.   "
256164|NCT01350518|"     The purpose of this research study is to determine whether increased intake of dietary fiber     during a 12-week, low-calorie weight loss intervention affects abdominal fat change and     improves cardiovascular risk factors in African-American women more than a standard weight     loss intervention.      The investigators are testing two main hypothesis:      Hypothesis 1: Women in the high dietary fiber intervention group will lose significantly more     abdominal fat around their organs than women in the standard fiber group.      Hypothesis 2: Women in the high dietary fiber intervention group will have lower blood     pressure, fasting glucose, fasting lipids and inflammatory factors at 3-months compared to     women in the control group.   "
256165|NCT01335399|"     The purpose of the study is to determine whether the addition of Elotuzumab to     Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)   "
256177|NCT01255826|"     The purpose of this study is to evaluate sustained lung inflation followed by early nCPAP as     delivery room ventilatory management for preterm neonates at risk of respiratory distress     syndrome in reducing their need for mechanical ventilation and ameliorating lung injury     without inducing adverse effects compared with intermittent bag and mask ventilation.   "
256179|NCT01284283|"     This post-approval study is being conducted to examine the performance of the STAR Ankle     under actual conditions of use.   "
256180|NCT01230996|"     This will be the first study to assess the clinical feasibility of dose escalation with     simultaneous integrated boost intensity-modulated radiotherapy for patients with locally     advanced cervical cancer. Following screening to confirm eligibility patients will commence a     six week treatment period. After this, patients will be followed up by visits to clinic every     3 months for a period of 24 months (2 years). End of study is defined as 24 months after     treatment. Patients will be followed up for a minimum of 5 years (as per local policy) after     treatment.   "
256210|NCT00860782|"     Children with sickle cell disease (SCD) are at risk for central nervous system (CNS)     complications, which may affect academic achievement. This study will evaluate an educational     support program for parents that aims to improve academic achievement in children with SCD.   "
256304|NCT03270397|"     MSc. course addressing the issue of body image among nutrition students while delivering the     course The group- theory and practice. A non-randomized controlled trial was conducted     between 2014 and 2016 with 135 dietetics' students in Tel Hai Academic College, Israel.     Changes in body image and eating disorders features were assessed between course conclusion     and baseline among participants within controlled efficacy study.   "
256305|NCT03269786|"     laboratory and ultrasongraphicc changes after endoscopical varices treatment   "
256182|NCT01222741|"     Background:      - Researchers are interested in studying disorders that make individuals more susceptible to     fungal infections, specifically infections with the Candida yeast. These disorders are often     related to problems with the immune system and may have genetic factors, which suggests that     researchers should study not only the individual with the disorder, but also his or her     first- and second-degree relatives (such as parents, siblings, children, and first cousins).     To provide material for future research, individuals with immune disorders and their first-     and second-degree relatives will be asked to provide blood and other samples for testing and     comparison with samples taken from healthy volunteers with no history of immune disorders.      Objectives:      - To collect blood and other biological samples to study immune disorders that make     individuals more susceptible to fungal infections.      Eligibility:        -  Individuals of any age who have abnormal immune function characterized by recurrent or          unusual fungal infections, recurrent or chronic inflammation, or other types of immune          dysfunction.        -  First- or second-degree genetically related family members (limited to mother, father,          siblings, grandparents, children, aunts, uncles, and first cousins).        -  Healthy volunteers at least 18 years of age (for comparison purposes).      Design:        -  Participants will provide blood samples and buccal (cells from the inside of the mouth          near the cheek) samples.        -  Participants with immune disorders will also be asked to provide urine samples, saliva          or mucosal samples, or skin tissue biopsies, and may also have imaging studies (such as          x-rays) to collect information for research.        -  Samples may be collected at the National Institutes of Health or at other clinical          locations for the samples to the sent to the National Institutes of Health.        -  No treatment will be provided as part of this protocol.   "
256185|NCT01196390|"     This randomized phase III trial studies how well radiation therapy, paclitaxel, and     carboplatin with or without trastuzumab work in treating patients with esophageal cancer.     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,     such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of     tumor cells to grow and spread. It is not yet known whether giving radiation therapy and     combination chemotherapy together with or without trastuzumab is more effective in treating     esophageal cancer.   "
256187|NCT01163461|"     This is a behavioral speech therapy trial for individuals who have suffered a stroke on the     left side of the brain and have difficulty speaking. The name of this disorder is called     'aphasia'. Individuals who participate in this study will receive 60 hours of therapy for     free (2 hours/day, 5 days/week, 6 weeks).   "
256189|NCT01153035|"     The purpose of this study will be to evaluate, in a multi-center setting, the ability of     radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the final     negative margin and consequently decrease the rates of re-operation. During the initial     breast conservation procedure (lumpectomy), immediately following routine surgical resection     of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh     lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the     resected specimen.   "
256193|NCT01077232|"     Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical     Practice.   "
256306|NCT03270020|"     This study is aiming to evaluate the efficacy of denosumab among adult patients suffering     from Langerhans Cell Histiocytosis (LCH).   "
256198|NCT01010256|"     The purpose of this study is to evaluate the level of a specific protein (PTEN) in the cancer     cells of chronic myelomonocytic leukemia (CMML) patients. This protein might be involved in     the transformation from normal blood cells to leukemia cells. The PTEN protein has not been     investigated in CMML specifically but it has been discovered in closely related cancers. If     this study demonstrates an abnormality in this protein, future testing will be designed to     evaluate the genetic abnormality that resulted in lack of the normal presence of this     protein. The goal is that the results of this study will help to develop new drugs and     strategies to treat the future patients with CMML by understanding the abnormality of the     disease at the cellular and molecular levels. The results of this study can also be utilized     by future studies to develop individualized treatment to patients who have abnormal levels of     this protein.   "
256199|NCT01004978|"     This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how     well they work compared with chemoembolization alone in treating patients with liver cancer     that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin     hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels     near the tumor and then blocking the blood flow to allow a higher concentration of the drug     to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known     whether giving chemoembolization together with sorafenib tosylate is more effective than     chemoembolization alone in treating patients with liver cancer.   "
256203|NCT00953992|"     -  To investigate the etiology, epidemiology and prognostic factors of acute kidney injury.        -  To find out risk factors that relate with the prognosis of acute kidney injury,focusing          on inflammation, oxidative stress and nutritional status.        -  To study on the relationship between gene polymorphism and prognosis of acute kidney          injury.   "
256615|NCT02481518|"     The purpose of this study is to determine whether magnesium preloading reduce incident of     cisplatin induced acute kidney injury in head and neck cancer who receiving low dose     cisplatin (40 mg/m2 weekly for 7 weeks).   "
256211|NCT00849407|"     Though it is generally accepted that exposure to sunlight is a major causative factor for     skin cancer, the risk for developing melanoma is not directly linked to sun exposure such as     in non-melanoma skin cancer. Therefore, a dual pathway has been proposed, distinguishing     melanoma that develops on skin that is chronically exposed to sunlight from those that occur     on skin that is normally protected. The risk for each type of melanoma is believed to be     determined in part by genetic factors. To define these markers reproducibly, the     investigators plan to establish a large cohort with comprehensive information regarding sun     sensitivity (skin type), history of experienced sun exposure, skin pigmentation phenotypes,     total number of nevi, and other types of skin tumors in a central European population. The     investigators will obtain blood from all participants for DNA as well as serum analyses.     Based on the finding that genetic variants of the melanocortin-1 receptor (MC1R) gene,     associated with red hair and fair skin, have been shown to be associated with increased risk     for melanoma, particularly those harboring BRAF mutations, the investigators will now focus     on the study of recently discovered genetic variants associated with pigmentation.     Furthermore, the investigators will study the relation of these variants with oncogenic     mutations of melanoma in BRAF, RAS and c-Kit. The study of other genetic variants will     follow, once a sufficiently large cohort has been established to reveal an independent     genetic risk factor in a multivariate analysis including potential covariates as mentioned     above. The identification of genetic risk factors for melanoma will not only help identify     individuals with increased risk but also improve our understanding of the molecular     background of the development of melanoma.   "
256212|NCT00843882|"     This randomized phase III trial studies lenalidomide to see how well it works with or without     epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may     stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Colony     stimulating factors, such as epoetin alfa, may increase the number of immune cells found in     bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective     with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.   "
256215|NCT00766779|"     A study comparing conventional chemotherapy to low dose total body irradiation-based     conditioning and hematopoietic cell transplantation from related and unrelated donors as     consolidation therapy for older Patients with AML in first Complete Remission.   "
256217|NCT00705926|"     This study will determine whether HIV treatment that is initiated during the acute phase of     HIV infection, followed by discontinuation of treatment, is effective in reducing the amount     of HIV and an increasing the amount of CD4 cells in the blood of people with HIV, compared to     the amounts of HIV and CD4 cells in people who do not receive treatment at this stage.   "
256218|NCT00675233|"     RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is     exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may     be an effective treatment for laryngeal cancer.      PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy     when given together with HPPH in treating patients with dysplasia, cancer in situ, or     invasive cancer of the larynx.   "
256219|NCT00671814|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     single rising oral doses and multiple oral doses of TR-701   "
256220|NCT00641641|"     The purpose of this study is to measure the decay characteristics of HIV in the blood of     patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV     drug, an integrase inhibitor. This study explores how this new combination of therapy reduces     virus in various compartments of the body and immune system.   "
256265|NCT03270579|"     The main purpose of the study is to measure the whole-body distribution and radiation     dosimetry of [18F]JNJ-64511070 in healthy male participants by positron emission tomography     (PET) (Part A); and to measure the uptake, binding, distribution, and washout of     [18F]JNJ-64511070 in the brain of healthy male participants by PET and to model tissue     specific kinetics of [18F]JNJ-64511070 with the appropriate arterial input function (IF)     (Part B).   "
256224|NCT00572481|"     We hypothesize that variations in anatomic location of the arm lymphatic drainage system put     the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping the     drainage of the arm during the procedure would decrease the likelihood of inadvertent     disruption of the lymphatics and the subsequent development of lymphedema. A combination of     radioactivity and blue dye will be used.   "
256227|NCT00483106|"     Attention deficit with hyperactivity disorder (ADHD) is a very common behavioral problem     during childhood. It is estimated that up to 80% of this disorder could be related to genetic     factors. The most common treatment for ADHD is psychostimulants. In this study, the     researchers investigate the effect of genetic variants in increasing the risk for behaviours     pertinent to ADHD or in modulating the response of these behaviours to methylphenidate.     Response to methylphenidate is evaluated through a double blind placebo controlled one week     study.   "
256287|NCT03270189|"     Cervical dystonia occurring only during the writing task is a rare form for which there is no     established treatment. Many authors agree that alteration of sensory integration is     associated with dystonia. Similar disturbances in the integration of oculomotor information     could have a role in cervical dystonia forms involving visuo-cervico-manual coordination such     as handwriting. We hypothesize that orthoptic treatment by wearing prisms when writing (i)     will reduce the abnormal posture of the head occurring whilst writing and remove the     associated nuchal pain; (ii) the correction after a period of systematic wearing of the     prisms during handwriting tasks will have a sustainable effect allowing to keep a normal head     position after the suppression of the prisms.   "
256230|NCT00407888|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide,     and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found     in bone marrow or peripheral blood and may help the immune system recover from the side     effects of chemotherapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Giving combination     chemotherapy and filgrastim together with trastuzumab may kill more tumor cells.      PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride,     cyclophosphamide, and filgrastim together followed by paclitaxel albumin-stabilized     nanoparticle formulation and trastuzumab works in treating patients with breast cancer     previously treated with surgery   "
256234|NCT00340288|"     Uterine leiomyomas, commonly called fibroids, are a major health concern for women of     reproductive age. The objectives of the study described herein are to investigate the growth     dynamics of uterine leiomyomas in a clinically relevant population of women. We will test the     hypotheses that uterine leiomyomas are heterogeneous in terms of their growth characteristics     and in their clinical symptoms or outcomes, and that differences in leiomyoma growth dynamics     can be discriminated by molecular markers and cellular phenotypes. Participants will include     300 premenopausal women (greater than 18 years old) with at least one uterine leiomyoma. The     inclusion criteria for patient enrollment is confirmed diagnosis of leiomyoma by ultrasound.     At least one leiomyoma must be equal to or greater than 2 cm in diameter and the uterus must     be enlarged to the size typical during the eigth week of pregnancy. After enrollment and     informed consent, T1- and T2-weighted magnetic resonance image (MRI) scans will be conducted     beginning at the first visit and then at 3, 6, and 12 months. Each patient will have a     physical exam, provide urine and blood samples at each MRI visit, and respond to an initial     extensive telephone-administered questionnaire followed by abbreviated monthly questionnaire     updates. A number of the enrolled women will require surgical intervention     (hysterectomy/myomectomy) as standard care. If surgery is an outcome for women enrolled in     the study, MRI will be conducted before surgery and the surgical pathologist will map uterine     leiomyomas for comparison to MRI. Leiomyoma samples will be analyzed for histopathological     and molecular changes correlated with growth. Because hysterectomy and myomectomy are common     outcomes in women with leiomyomas, we anticipate tissue will be available from at least 100     of the 300 women in the study. For those women who opt for surgery, we will also administer a     brief (less than 5 minute) questionnaire clarifying their reason for electing surgery. Upon     completion of data collection, we will be able to compare leiomyoma growth as a function of     multiplicity and location; examine the relationship between leiomyoma growth and clinical     symptoms or outcome; identify molecular, cellular, and pathological characteristics of     leiomyomas with differing growth dynamics; and examine endocrinological parameters and     lifestyle factors related to differential growth dynamics of uterine leiomyomas. The data may     be used to establish a clinical severity scale and establish diagnostic markers currently not     available for uterine leiomyomas.   "
256238|NCT00305825|"     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different     ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others     interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the     growth of tumor cells by blocking blood flow to the tumor. Estrogen can cause the growth of     breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the     amount of estrogen the body makes. Giving bevacizumab together with letrozole may be an     effective treatment for locally advanced or metastatic breast cancer.      PURPOSE: This phase II trial is studying how well giving bevacizumab together with letrozole     works in treating postmenopausal women with locally advanced or metastatic breast cancer that     cannot be removed by surgery.   "
256240|NCT00127660|"     A study examining menu choices made at fast food restaurants.   "
256266|NCT03270709|"     Supplementation with vitamin D improves HIV+ macrophages phagocytosis in vitro. There is     evidence to suggest that administering vitamin D can in fact improve immune function in     individuals. The study will evaluate the impact of high dose vitamin D in HIV+ smokers' and     HIV- smokers' in vivo. The primary goal is to improve innate immune host response to     infection in patients already at high risk by virtue of HIV and smoking status.   "
256267|NCT03270566|"     An outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water     softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study   "
256243|NCT00064883|"     This study will: 1) provide standard non-experimental radiation therapy to children who have     a form of cancer or similar disease process that is of scientific interest, importance, or     educational value; 2) determine the effects of radiation on childhood cancers; and 3) allow     for the education of nurses, medical students, residents, clinical fellows, and physicians in     the management and care of this specialized group of cancer patients. Patients in this study     will not receive experimental therapy, but will be given standard medical care.      Patients eligible for this study include: 1) children with cancer or a precancer syndrome,     such as aplastic anemia or other myelodysplastic syndrome, who are between 6 months and 21     years of age and whose disease will be treated or has been treated with radiation therapy in     the NCI's Radiation Oncology Branch (ROB); 2) patients with cancer or a precancer syndrome     who have disease manifestations of special interest to ROB investigators; and 3) patients     with cancer or a precancer syndrome who offer an important educational benefit to radiation     oncology trainees and staff.      Participants will undergo a medical history, physical examination, and blood tests, and     radiation therapy. Before beginning treatment, medical information such as pathology reports,     laboratory results, diagnosis and treatment history, scan results, and so forth, will be     obtained from the patient's medical records. Additional procedures that may need to be done     include scans, such as magnetic resonance imaging (MRI), computed tomography (CT), positron     emission tomography (PET), lung function tests, arteriogram, or tumor biopsies.      Participants will then have a (simulation) treatment planning session for radiation therapy     during which measurements are taken, CT images are taken, and markings are placed on the body     to help determine the treatment area. The radiation will be delivered to the body by a     machine called a linear accelerator, which produces x-rays. Radiation therapy is generally     given once or twice a day 5 days a week. Each treatment takes about 10 minutes.      When the course of treatment is completed, patients return to the Radiation Oncology clinic     for follow-up visits that include blood tests, a physical examination, and review of     symptoms, if any. Visits are kept to a minimum, but continue for a prolonged period to watch     for any late effects of treatment that may occur over a period of decades.   "
256268|NCT03270878|"     This study is intended to estimate the absolute bioavailability of Glasdegib by comparison of     the pharmacokinetic exposures following administration of an oral, single dose 100 mg tablet     vs. an IV infusion of a 50 mg IV dose in the fasted state in a crossover fashion to healthy     volunteers.   "
256269|NCT03270670|"     The purpose of this study is to test whether the 19-gauge needle can collect more tissue and     get better sampling during a bronchoscopy procedure.   "
256270|NCT03271021|"     A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of     Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne     Vulgaris (Study FX2017-22)   "
256288|NCT03270683|"     Objective: To assess neurologic prognostication by early Transcranial Doppler Sonography     (TCD) in comatose survivors after cardiac arrest.      Design: Prospective study between May 2016 and November 2017 in a medical intensive care unit     and cardiac intensive care unit in a university hospital.      Patients: all comatose patients older than 18 years successfully resuscitated from an     out-of-hospital cardiac arrest (OHCA). Patients for whom OHCA is associated with traumatic     brain injury, no window for TCD measurements, or dead before neurological prognostication are     excluded.   "
256247|NCT00026754|"     The purpose of this protocol is to provide patients with adequate informed consent to     understand that screening tests with minimal health risk will be performed to evaluate their     eligibility for a research study. The protocol makes it clear that patients initial visit to     the intramural clinical program may include screening studies that are not medically     necessary for disease management, but are done purely for research purposes.      Patients with a known or suspected diagnosis of cancer, HIV infection, skin disorder or     immunodeficiency who are being considered for enrollment in a National Cancer Institute     intramural clinical research protocol will participate in this consent protocol. It informs     patients of screening tests and procedures involving minimal risk that are done for research     purposes only, including blood tests, electrocardiogram, standard X-rays (e.g., chest X-ray),     bone films, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine     studies. It explains that other eligibility screens that are more invasive and involve     greater risk, such as a biopsy, will require separate consent.   "
256248|NCT00006177|"     This research protocol seeks to learn more about bipolar disorder in children and adolescents     ages 6-17. Researchers will describe the moods and behaviors of children with bipolar     disorder and use specialized testing and brain imaging to learn about specific brain changes     associated with the disorder. This protocol studies children who have been diagnosed with     bipolar disorder, and those who have a sibling or parent with bipolar disorder and are thus     considered at risk for developing the disorder.   "
256250|NCT00001160|"     Participants in this study will be patients diagnosed with or suspected to have a thyroid     nodule or thyroid cancer.      The main purpose of this study is to further understand the methods for the diagnosis and     treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the     context of standard medical care that is offered to all patients with thyroid nodules or     thyroid cancer. Other tests are performed for research purposes. In addition, blood and     tissue samples will be taken for research and genetic studies.   "
256251|NCT03270904|"     Diabetic foot disease is a global health problem. Diabetes affects over 450million people     worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their     feet and up to 25% will develop a diabetic foot ulcer (DFU - a wound on the foot). More than     half of DFUs become infected requiring hospitalisation and 20% of infections result in     amputations contributing to 80% of non-traumatic amputations performed in the developed     world. DFUs cost the NHS £1billion in financial year 2014-15.      A diabetic foot ulcer is a form of chronic wound. Chronic wounds are wounds that fail to     progress through the normal phases of wound healing in an orderly and timely manner and     become hard to heal. Almost all chronic wounds are known to have bacteria within and this is     termed colonisation. Wounds can progress from being colonised to becoming infected. The     concentration of bacteria can predict delayed healing or infection.      This study aims to use a novel hand held device, Moleculight i:X™, in a pilot study to     investigate the clinical effectiveness and decision making associated with its use in the     assessment of DFUs. Moleculight i:X™ is a hand held device that emits violet blue light. By     controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria     above a pre-determined concentration by identifying natural fluorescence in the bacteria cell     wall.      Patients attending a specialist DFU clinic will be screened and if eligible and consenting     will be recruited. Patients will be randomised into two groups; those who receive treatments     as usual (TAU) alone (in line with NICE guidelines) and those that receive TAU plus     Moleculight i:X™ imaging. The main objective is to describe the proportion per group with     healed DFUs at 12week follow up in these two comparable groups of 30 patients each.   "
256252|NCT03270618|"     The purpose was to assess the accuracy and clinical validation of virtual planning and     surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia     were enrolled. Virtual planning and simulation were performed on three-dimensional models.     Distraction was simulated on virtual model and the new morphology of the mandible was     predicted. The position and direction of the distractor was determined to achieve the optimal     morphology. The templates were designed based on virtual planning and manufactured using     three-dimensional printing technique. The template is designed to assist the surgeon to     perform the osteotomy and predrill the screw holes to guide the distractor position. The     outcome evaluation was completed by comparing planned outcomes with postoperative outcomes.     Linear and angular differences for the distractor was measured.   "
256253|NCT03270644|"     This study will assess the effects on heart rate and blood pressure when a single dose of     lasmiditan is administered with a daily dose of propranolol. This study will also measure how     much lasmiditan gets into the bloodstream after taking lasmiditan alone and after taking it     together with propranolol. The study will also look at how well both drugs are tolerated.     Information about any side effects that may occur will be collected.      This study will last approximately 45 days including screening. This study will require 13     days/12 nights in a Clinical Research Unit (CRU) followed by 1 follow-up appointment     approximately 7 days after the last dose. Screening is required within 28 days prior to the     start of the study.      This study is for research purposes only and is not intended to treat any medical condition.   "
256271|NCT03270215|"     To investigate the diagnostic power of computed tomography for discriminating malignant from     nonmalignant causes to pleural effusions in consecutive patients with no malignant cells     found at a cytological examination and a chest x-ray not suspicious of malignancy. The     investigators hypothesised that the combination improves the chance of detecting the cause of     the pleural effusion.   "
256254|NCT03269578|"     Background:      People who join a study in the Developmental Therapeutics Clinic (DTC) have tests. These     include blood draws and biopsies. Researchers collect data from these samples. Some people     take part in more than one study at the DTC. At this time, data are connected only with one     single study. Researchers want to access people s medical records. This will allow them to     link the research data from all their studies they have or will take part in. Researchers     also want to collect medical data about their diagnosis and treatment history. This will     allow them to see how their cancer reacted to different drugs over time.      Objective:      To enter people into a master protocol to connect research sample and treatment data across     DTC studies.      Eligibility:      People ages 18 and older who are being evaluated or treated for cancer in the DTC      Design:      Participants will allow researchers to look at all the data from their research samples. This     includes those from their current, past, and any future NIH studies.      Participants will allow researchers to access some of their medical data. This includes age,     diagnosis, treatment history, and response to treatment.      Participants will provide no new samples.   "
256255|NCT03270657|"     The purpose of this study is to measure neural activity during deep brain stimulation (DBS).     There are two types of neural activity that we will record from DBS electrodes during this     study: DBS local evoked potentials (DLEPs) and spontaneous, local field potentials (LFPs). We     will measure the effects of varying stimulation parameters on both the neural activity and     changes in motor symptoms -- bradykinesia and tremor -- in subjects with Parkinson's disease     (PD). Correlating neural activity characteristics with changes in symptoms will improve our     understanding of the mechanisms of action of DBS. This intraoperative study will specifically     compare our ability to record neural activity using circuitry developed at Duke for this     purpose [Kent et al, 2015] to a new, implanted pulse generator (IPG; RC+S) developed by     Medtronic. These intraoperative studies will specifically test a preliminary version of the     RC+S (that is not designed for implantation), and will lead to a clinical trial assessing the     efficacy of the implantable RC+S IPG in PD patients once this device is available and     approved for this trial.   "
256256|NCT03271125|"     The aim of this study was to evaluate the safety, feasibility and preliminary effects of a     high-intensity rehabilitative multimodal training protocol carried out on treadmill on     walking efficacy, mobility, balance, executive function, fatigue and health-related quality     of life in a sample of persons with moderate to severe MS deficit of mobility compared to a     control group that received a strengthening program of similar intensity.   "
256257|NCT03271112|"     In Reunion Island, people encounter environmental and social conditions leading to premature     ageing and subsequent frailty. Social welfare has developped exercise programs to promote     physical activity especially for elderly with higher risk factors of frailty, including low     incomes.      The study evaluates the potent benefit effect of such exercise program on physical     performance and frailty improvement in seniors from Reunion Island. All seniors participate     to a 12-weeks exercise program especially dedicated to this targeted population needs and     ability.   "
256258|NCT03271099|"     This study seeks to enroll patients receiving a Survivorship Care Plan following curative     therapy for cancer. Participants will be randomly assigned to receive usual care or to be     followed by a Patient Navigator as part of their Survivorship Care Plan.   "
256259|NCT03271086|"     Family-centered Relaxation Breathing Training in the Pediatric Outpatient Clinic:      The long term goal is to apply simple, low cost, assistive technologies (heart rate     variability [HRV] biofeedback together with mobile health tools) to teach relaxation     breathing in the Boston Medical Center pediatric clinic setting following a trauma-informed     care model. For this research both a mobile app for relaxation breathing skills and reminder     text messages will be provided for the at-risk target population. The investigators will     assess the feasibility and acceptability of relaxation breathing intervention in 60     parent-child dyads. These dyads will be randomly assigned to receive either (1) biofeedback     relaxation training alone or (2) Technology-enhanced relaxation breathing (biofeedback     relaxation training together with mobile health tools). Outcome measures will assess     relaxation breathing practice, anxiety, and parental stress at the time of the intervention     and at one month follow up.   "
256260|NCT03271073|"     Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good     safety and efficacy as third-line therapy for advanced gastric cancer.We conducted this trial     to investigate the safety and efficacy of apatinib combined with S1 after failure of     first-line chemotherapy in advanced gastric cancer or gastroesophageal junction carcinoma     patients.   "
256261|NCT03271060|"     The first technique described for interbody fusion was the anterior lumbar interbody fusion     (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal     or transperitoneal approach.      While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's,     Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).   "
256262|NCT03271047|"     This is a multicenter, open-label, Phase 1B/2 study to evaluate the safety and assess the     preliminary anti-tumor activity of binimetinib administered in combination with nivolumab or     nivolumab + ipilimumab in adult patients with advanced metastatic colorectal cancer (mCRC)     with microsatellite stable (MSS) disease and presence of a RAS mutation that have received at     least one prior line of therapy and no more than 2 prior lines of therapy. The study contains     a Phase 1b period to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose     (RP2D) and schedule of binimetinib followed by a randomized Phase 2 period to assess the     efficacy of the combinations.   "
256263|NCT03270592|"     For persons with impairments and certain illnesses the use of service dogs may have positive     effect. The effects of using these dogs to assist in every day life need to be studied     further.The aim of the study was to assess how health care consumption was effected by using     certified service dogs and to study the cost-effectiveness of having a certified service dog.   "
256264|NCT03270605|"     Cesarean Myomectomy for safety regarding operative blood loss and need for further     interventions and postoperative hospital stay.   "
256272|NCT03270150|"     The study is a prospective open-label single-arm study that includes four treatment     procedures and three follow-up visits. Outcomes will be measured according to photography     evaluation, subject's satisfaction and occurence of AE.   "
256295|NCT03268824|"     Focal epilepsy is associated with widespread alterations in structural brain connectivity,     often present at the disease onset and related to learning disabilities. Whether ongoing     seizure activity contributes to network pathology is a matter of debate. This study intends     to measure the impact of seizures on structural connectivity on a local and on a global     level. In children examined with intracerebral electrodes to evaluate whether a surgical cure     can be proposed, we combine intracerebral stereotactic electroencephalography (EEG)     recordings with diffusion weighted imaging of white matter fibers. On the local level, the     study will quantify the number of deficient connections in the seizure onset zone. On a     global level, the study will compare the white matter fibers of the left and right hemisphere     to probe whether physiological language lateralization is preserved.   "
256548|NCT02705313|"     Advanced Accelerator Applications is currently pursuing marketing approval for     177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to     allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine     tumors, progressive under somatostatin analogue therapy to access the investigational     product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.   "
256273|NCT03270254|"     Gum disease is a common disease, which affects 45% of the UK adult dentate population. It is     caused by bacteria in dental plaque, which produces inflammation and a deepening of the     natural crevice between the gum and the tooth surface. A crevice of 3mm is considered to be     within the normal range, but anything ≥4mm is considered to be abnormal and is called a     pocket. Standard treatment of gum disease is mechanical cleaning aimed at removing bacteria     off the root surfaces of the teeth. For most teeth, in the majority of patients, this can be     achieved by root surface debridement (RSD), which involves passing instruments into the gum     pockets to clean the roots. Previous studies have shown that the outcome of treatment is less     effective when the pockets are deeper, or where there is bone or root anatomy which makes     access for RSD difficult. In such instances additional approaches, such as repeating RSD,     surgical access, or the additional use of antibiotics are considered. This clinical study     will investigate the benefits and drawbacks of using a light source and dye (photodynamic     therapy - PDT) as an additional treatment compared to the standard treatment of RSD alone.     Patients with chronic gum problems who have undergone 1 cycle of RSD, but have residual     pockets will be invited to join the study. All residual pockets will be treated with the     conventional treatment of RSD. Following a random allocation process the residual pockets in     half the mouth will receive additional treatment with PDT at the same appointment. Patients     will be followed up for 3 months to evaluate the clinical benefits and any side effects. The     aim of the study is therefore to evaluate if this localised, simple treatment can add benefit     to RSD alone, thus reducing the need for antibiotics or surgery to treat residual pockets.   "
256274|NCT03270852|"     The researchers found that enhanced reality developed for the first time in the word by us     had a synergistic or additive effect on brain plasticity in patients without central nervous     system injury. The aim of this study is to determine the validity and feasibility of enhanced     reality in hemiparetic arm in the stroke patients with central nervous system injury.   "
256275|NCT03270267|"     Study of the causes and rate of school absenteeism in children and adolescents with     Inflammatory Bowel Disease.   "
256276|NCT03270384|"     The study described below is designed to assess the safety and device performance for the     drug coated balloon (DCB) for the treatment of urethral stricture.   "
256277|NCT03270774|"     Background: Central Venous catheter insertion technique and indwelling time are major risk     factors for CVC colonisation. Colonisation occurs through microbial migration and biofilm     formation along the catheter insertion tract. This study set out to determine the prevalence     and associated factors for central venous catheter colonisation among critically ill patient.     No data exists in this clinical setting addressing this topic.      Methods: The study population included 100 participants with central venous catheters in situ     for at least 24 hours. Catheter tip (distal 5-cm segment) and blood cultures (10mls     peripheral blood) were obtained at the time of catheter removal.   "
256278|NCT03270982|"     Clinical Data evaluation to document the performance and clinical outcomes of the     Comprehensive Segmental Revision System.   "
256279|NCT03269682|"     Oculomotor nerve (third cranial nerve or III) palsy is a relatively frequent cause of     consultation in ophthalmology.      It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and     therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the     oculomotor tract is the first-line examination required. In our usual clinical practice, we     noticed in several patients unusual contrast enhancement within the oculomotor nerve on T1     sequence with gadolinium injection, observed in various locations along the nerve path     (cavernous and/ or intra-orbital segment).      This contrast enhancement, could confirm the nerve impairment This study aims to analyse the     efficiency of a new sequence 3D PD T1 which isotropic spatial resolution less than 1mm, not     yet described in the literature, to depict this enhancement.      In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this     MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate     differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis     (inflammatory or ischemic origin). This new sequence 3D PD T1 sequence focused on the III     could thus be systematically included in the usual MRI protocol.   "
256280|NCT03269669|"     This randomized phase II trial studies how well obinutuzumab with or without PI3K-delta     inhibitor TGR-1202, lenalidomide, or combination chemotherapy work in treating patients with     grade I-IIIa follicular lymphoma that has come back or does not respond to treatment.     Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells     to grow and spread. PI3K-delta inhibitor TGR-1202 may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Biological therapies, such as     lenalidomide, use substances made from living organisms that may stimulate or suppress the     immune system in different ways and stop cancer cells from growing. Drugs used in     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and     prednisone, work in different ways to stop the growth of cancer cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. It is not yet     known whether giving obinutuzumab with or without PI3K-delta inhibitor TGR-1202,     lenalidomide, or combination chemotherapy will work better in treating patients with grade     I-IIIa follicular lymphoma.   "
256281|NCT03269604|"     Asymptomatic bacteriuria (AB) is the isolation of a bacterium in a sample of urine     appropriately collected from a person who does not have signs or symptoms of urinary     infection. It is common in diabetic women, in pregnant women, in men over 60 years and in     patients with spinal cord injury.      There is clinical evidence that AB should be treated in patients who will be operated on with     urologic surgery because of the risk of presenting infectious complications; however, the     timing of initiating antibiotic therapy has not been established, even in some studies the     prophylaxis has been considered from one to seven days prior to the procedure, without     determining the differences in the outcome for each one of the interventions and causing an     undue and risky use of antibiotics.      A randomized, parallel-design, single-masked clinical trial will be performed to compare and     analysis the bloodstream infections, surgical site infections, readmissions and hospital stay     in three intervention groups, 1) those receiving antibiotics during the previous 5 days to     the procedure; 2) 3 days prior to the procedure; and 3) those who receive only a single dose     of antibiotic on the day of the procedure.      The main expected result is to identify the timing of initiation of antibiotic prophylaxis in     urological procedures in patients with asymptomatic bacteriuria, with the purpose of     diminishing the bloodstream and of the surgical site infections. If it is scientifically     demonstrated that those patients who receive a single dose of antibiotic on the same day of     the procedure, have the same safety and effectiveness compared to the other two groups, would     reduce hospital stay, surgical waiting time and indiscriminate use of antibiotics that     generate multidrug-resistant microorganisms, thus generating an impact on Public Health and     on the quality of care.   "
256549|NCT02691260|"     The purpose of this study is to determine the feasibility of providing incentives to people     enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.   "
256289|NCT03267277|"     Background:      Dermatomyositis (DM) and juvenile dermatomyositis (JDM) cause inflammation in the muscles.     People with DM and JDM can develop calcium deposits in places they should not, known as     calcinosis. Calcinosis can be painful and cause disabilities and other problems. Researchers     want to learn more about calcinosis to find treatments for it.      Objective:      To test if sodium thiosulfate (STS) can treat people with DM with calcinosis.      Eligibility:      People ages 7 and older who have moderate or severe calcinosis. They must have stable DM and     calcium deposits in the torso or at least 2 limbs.      Design:      Participants will be screened with:        -  Medical history        -  Physical exam        -  Muscle strength and function tests        -  Blood and urine tests      Participants will have several visits:        -  7-day pre-treatment visit about 10 weeks before starting STS        -  Treatment visits over 10 weeks. They will get STS 3 times a week through IV infusion.          They may be hospitalized the whole time. If they tolerate the drug, they may be          discharged at certain times. During these times, they will return for the infusions.        -  3- to 5-day post-treatment visits 24 weeks and 62 weeks after starting STS.      Visits may include repeats of screening tests and:        -  Questionnaires        -  Scans: They lie in a machine that takes pictures of the body. They may be injected with          a radioactive agent.        -  Durometry: A small instrument applies pressure on the skin or exposed calcinosis.        -  Measurements of blood flow in the arms and fingernail blood vessels        -  Photographs of the skin        -  Kidney ultrasound        -  Tests of kidney function        -  Calcinosis aspiration: A needle placed into areas of calcinosis removes liquid.   "
256290|NCT03268096|"     Knowledge of the evolution of multiple sclerosis (MS) and its long-term prognostic factors is     essential to guide the therapeutic management. However, it remains partial and concerns above     all data collected during the first years of the disease. The evolution towards disability     can only be assessed after a follow-up of more than 10 years and does not depend solely on     the initial inflammatory activity of the disease. We propose to realize a standardized     clinical assessment, an optical coherence tomography (OCT) and a cerebral MRI 15 years after     the first clinical manifestation of the disease.      Clinical and paraclinical assessment will consist in the realization of additional MRI     sequences in order to obtain more precise information on cerebral lesions (unconventional     parameters). Optical coherence tomography (new generation device) will also be performed on     both eyes to describe the thickness of the different layers of the retina. A clinical     evaluation will be performed with the Expanded Disability Status Scale (EDSS).      This study aims:        1. to describe the current clinical situation of patients (e.g. percentage of patients with          moderate or severe disability)        2. to explore the associations between MRI parameters, those measured with OCT and clinical          characteristics (disability)        3. to explore clinical and paraclinical prognostic factors of pejorative evolution          (disability, severe cerebral atrophy, etc.)   "
256291|NCT03271034|"     Lipedema is a disorder characterized by massive, bilateral accumulation of fat below the     waist and in the legs. Enlargement of the lower extremities is often accompanied by leg pain     and accumulation of fluid. Little is known about the functional changes that lead to fat     accumulation and pain in women with lipedema. The goals of this project is to conduct a     comprehensive characterization of abdominal and femoral fat tissues from women with lipedema     and to evaluate the potential effect of a diet-induced weight loss as a therapy.      Once enrolled in the study, the following tests will be conducted on lipedema subjects: 1)     characterization of body composition (fat tissue distribution), insulin sensitivity (response     to insulin), adipose tissue biology, and vascular function (how arteries dilate/contract) and     immune system function/inflammation. As control, we will have two control populations:     BMI-matched women that are metabolically normal obese (MNO) and Metabolically Abnormal Obese     (MAO) already analyzed in different studies at Washington University (IRB# 201512086 and     201610005). The MAO and MNO subjects underwent the same testing described above for the     lipedema. Therefore, we will use the data generated from IRB# 201512086 and 201610005 as     comparison groups in the statistical analysis to understand differences and similarities     between lipedema and obesity.      A second aim of the study is to determine the effect of diet-induced weight loss on body     composition, insulin sensitivity, adipose tissue biology, and vascular function in the women     with lipedema and compare these results with data obtained from BMI-matched women with MAO     participating in another study at Washington University (IRB# 201512086). The MAO population     will be used as control populations and data generated from the IRB# 201512086 will be used     as comparison group for statistical analysis. The results from this second aim of the study     will hopefully provide important insights on the efficacy of diet therapy in managing     lipedema.ed   "
256292|NCT03268538|"     Introduction: Chronic obstructive airway disease (COPD) is common condition in old age and     the perception of hypoxia is often impaired in some COPD patients. Therefor it is need to     monitor oxygen saturation in older people with COPD. A finger wearable device has been     developed to measure oxygen saturation and heart rate variability. The investigators     therefore will perform a cross sectional study to evaluate the clinical application of this     finger wearable device in the detection and management of COPD in older people.      Subject and method: 100 COPD subjects and 200 community dwelling older people without     diagnosis of COPD will be recruited. Physical functioning and lung function test will be     performed. Subjects will wear a finger wearable device to monitor heart rate variability and     oxygen saturation and wear another wrist wearable device (Actigraph) to monitor physical     activity and sleep for 6 days at the same time.      Statistical analysis: Statistical analysis will be made to examine the potential association     between oxygen saturation and physical activity and sleep, and the association between heart     rate variability and physical activity and sleep.   "
256293|NCT03268564|"     Objectives To evaluate the efficacy of a program promoting HIV self-testing (HIVST) with     online real-time counselling (HIVST-online) among men who have with men (MSM) in Hong Kong.      Participants Inclusion criteria are: i) Hong Kong Chinese speaking males aged ≥ 18 years old,     ii) self-report having had anal sex with at least one man in the last six months, iii)     willing to leave contacts (mobile phone and/or social media account), and iv) having access     to online face-to-face communication tools like Line, Skype, or Facetime. Those having been     diagnosed as HIV positive will be excluded.      Design A total of 350 eligible MSM will be recruited and invited to participate the program,     including 120 HIVST-online users in a HMRF project (ref#11120791) (re-testers), and 230 new     prospective HIV testers (new-testers) through outreaching at gay venues (bars and saunas),     internet and social media, and referrals made by participants.      A brief baseline telephone survey will be conducted among all participants they are exposed     to the components of the health promotion program. All participants will be followed up at     Month 6 by phone/social media for outcome and process evaluation.      Main outcome measures The primary outcome is whether the participant has taken up our     HIVST-online service during a 6-month follow-up period. This behavioural outcome will     recorded objectively by the HIVST administrators. Among those who had not taken up HIVST at     Month 6, they will be contacted by social media to ask a few questions to assess secondary     outcomes, which include: 1) whether having taken up any form of HIV testing other than     HIVST-online and 2) intention to take up HIVST-online or other forms of HIV testing in the     next six months. Process evaluation of the health promotion components (e.g., online video,     MI, and project webpage) and the HIVST-online service (e.g., delivery of the HIVST kits,     appointment making with HIVST administrators, pre- and post-test counseling) will also be     conducted.   "
256294|NCT03271151|"     Post-discharge pain after total knee arthroplasty remains problematic; many patients have     excessive pain at the 2 week time point (and often thereafter). Reduction in opioid use has     become a national goal, due to the 'epidemic' in opioid misuse.   "
256296|NCT03268876|"     Based on an improved understanding of how the extent of successful cytoreduction is     influenced both by inherent tumor biological characteristics as well as the aggressiveness of     the surgical approach this project aims to better define the value of cytoreduction and to     use the knowledge gained to develop more individualized therapy and follow-up. This will be     achieved through a translational biomedical research approach. Due to the research group's     traditions clinical phenotyping, biomarker identification, and clinical trials will be the     focus.   "
256297|NCT03271164|"     This is a prospective randomized controlled case series in patients having a surgery for     bilateral breast reduction. Objectives of the case series are to evaluate the safety and     efficacy of the FBPM10 System when compared with standard of care (massages with vitamin E     cream) in the treatment of post-surgical wounds.   "
256298|NCT03270176|"     The study is primarily designed to assess the safety and tolerability of escalating oral     doses of Debio 1143 and preliminary anti-tumour activity when combined with the standard dose     of avelumab in participants with advanced solid malignancies.   "
256299|NCT03270280|"     Periodontitis is an infectious inflammatory disease affecting the periodontal tissue     (Gingivae, alveolar bone, periodontal ligament and cementum). Chronic Periodontitis is     considered to be the most prevalent disease after dental caries which is linked to increased     levels of C- reactive protein, interleukins and matrix metallo-proteinases. Interleukin- 1β     and Matrix metalloproteinase-8 have been shown to be robust markers of inflammatory cascade     of chronic periodontitis.Various treatment modalities including scaling and root planing,     toothpastes and chlorhexidine based mouthwashes have been are known to be associated with     various side effects like teeth staining, altered taste sensation, mucosal burning. Hence,the     use of natural medicaments could provide a better alternative because of their fewer side     effects and cost effectiveness.   "
256300|NCT03270917|"     The international and multicentre ORANGE SEGMENTS - Trial is a prospective, double blinded,     randomized controlled study comparing patients undergoing parenchymal preserving resection of     postero-superior liver segments (involving one or two of segments 4a, 7, 8). All patients     will be participating in an enhanced recovery programme.      Primary outcome is time to functional recovery. Secondary study parameters include hospital     length of stay, intraoperative blood loss, operation time, liver specific morbidity,     readmission percentage, resection margin, quality of life, body image and cosmesis , reasons     for delay of discharge after functional recovery, long term incidence of incisional hernias,     hospital and societal costs during one year, time to adjuvant chemotherapy initiation,     overall five-year survival.   "
256301|NCT03267719|"     The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical     treatment option in patients with mild and moderate stress incontinence.   "
256302|NCT03267953|"     Internet-based stress management programs adapted to patients' needs      Stress is inevitable, and it has many negative consequences on the health of everybody, but     particularly on the health of patients with a cardiovascular disease (CVD). The good news is     that patients with CVD can learn to better control their stress through stress management     programs. Most stress management programs are offered face-to-face by a trained health care     professional. Research has shown that these programs have a positive impact on the health of     patients with CVD, including reducing mortality and other risk factors that can make the     disease worse (e.g., reduces blood pressure). Because of these benefits, the recommendation     is to offer a stress management program to as many patients with CVD as possible. The problem     is that their delivery is challenging for most clinics (e.g., too costly to run, health care     professionals are not available). This means many good stress management programs never make     it to the patient. Patients also face barriers in accessing traditional stress management     programs such as stigma or need to travel. Therefore, new approaches are needed to allow     findings from research to actually have an impact on the public's health.      One of these approaches is to use the internet to deliver stress management programs. The     internet has now been used for about 10 years to deliver a range of programs to patients.     There are limitations to this approach as well. For instance, 40-60% of patients who will use     an internet-based program will not benefit from it. These patients need more support or     guidance to get the most out of their internet-based program. This is the problem addressed     using the proposed innovative trial design. Investigators aim to improve the number of     patients with CVD who improve after receiving a stress management program by changing the     type and level of support they receive over time. This type of innovative trial design is     more and more popular, but has never been used to enhance a stress management programs for     patients with CVD.   "
256303|NCT03269214|"     Patients who had bisphosphonate-related osteonecrosis of the jaw in stage II were allocated     in two groups randomly : In group1, 10 patients underwent debridement and primary closer of     the area,in group 2 , patients received Phenytoin + tetracycline topically in the debridement     area.Wound dehiscence , infection and pain were in 1,6 and 12 months after treatment.   "
256308|NCT03263000|"     Background:      Some people who have increased blinking may later develop blepharospasm. Blepharospasm is a     neurological disorder that causes involuntary closing of the eyes. Researchers want to learn     more about how eyes close in response to different stimuli. They want to study this in     healthy people, people with increased blinking, and people with blepharospasm.      Objective:      To learn how light exposure affects people with blepharospasm.      Eligibility:      People ages 18 and older with blepharospasm or increased blinking, and healthy volunteers      Design:      Participants will be screened with:      Medical history      Physical exam      Neurological exam      Participants will have up to 5 visits. The number of visits will depend on the number of     tests they opt to have. They can opt to have up to 4 tests. Visits last 60-90 minutes. They     cannot drink alcohol or caffeinated drinks for at least 12 hours before visits. Visits could     include the following tests:      Evaluation of eyelid movements. This will be video recorded.      Electromyography: Small sticky electrodes are placed on the lower eyelid skin. These are     attached to wires. Muscle activity is recorded during blink reflex procedures.      Electrical stimulation: An electrode is placed close to the eyebrow. It will deliver small     electrical shocks. The strength of the shocks will be enough to provoke a blink.      Photic stimulation: A lamp is placed in front of the face. It will deliver single or paired     flashes. The flashes will be at various intervals and intensities. Participants will wear a     patch over one eye during this test.      Combination of electrical and photic stimulation   "
256341|NCT03249077|"     In preparation for the rollout of Medicare Diabetes Prevention Program (DPP) in 2018, Kaiser     Permanente Northwest (KPNW), a large, integrated health care system, plans to pilot the     implementation of Medicare DPP starting in April 2017. The Health Engagement and Wellness     Services at KPNW will randomize Medicare patients 65 and older to one of two treatment arms:     1) patient choice between DPP in-person or online; or 2) Usual care. Researchers at the KPNW     Center for Health Research will plan to augment the limited analysis planned by KPNW with a     pragmatic, rigorous quantitative and qualitative evaluation to better inform future     implementation efforts of Medicare DPP within and outside of KPNW.   "
256342|NCT03244670|"     A cohort study on incidence and progression of myopia in a group of medical students   "
256309|NCT03263013|"     Background:      Functional movement disorder (FMD) causes involuntary movements, such as spasms, shaking, or     jerks. These symptoms are not due to a recognized neurological or medical cause. Researchers     want to better understand how the brain works to cause these symptoms.      Objective:      To test if intermittent theta burst stimulation (iTBS) affects brain areas involved in FMD     symptoms. Also, to look at the effect of iTBS on mood and motor symptoms.      Eligibility:      Right-handed people ages 18-65 who have FMD and participated in protocol 07-N-0190      Design:      Participants will have 4 visits.      In Visit 1, participants will be screened with:      Medical history      Physical exam      Urine test      Questionnaires      Visit 1 might also include a brain MRI and functional MRI. The MRI scanner is a cylinder     surrounded by a strong magnetic field. They will lie on a table that can slide in and out of     the cylinder. For the functional MRI, they will be asked to perform tasks during the MRI     scan.      Visit 2 will be 1-2 weeks after Visit 1. Visits 2, 3, and 4 will be no more than 48 hours     apart. These include:      Electromyography: Small electrodes are taped to the skin. Muscle activity is recorded while     participants receive magnetic stimulation of the brain.      Transcranial magnetic stimulation and iTBS: A wire coil is held on the scalp. A brief     electrical current passes through the coil and creates a magnetic pulse to stimulate the     brain. During iTBS, participants will sit quietly and watch a nature documentary. They will     wear earplugs and a cap.      MRI      Functional MRI      Questionnaires   "
256310|NCT03267316|"     This study will evaluate the safety, tolerability, and preliminary antitumor activity of     CAN04 both as a monotherapy and in combination with standard of care treatment in subjects     with solid cancer tumors.      Following completion of the first part, the dose escalation cohorts, and determination of     maximum tolerated dose or recommended phase 2 dose (MTD/RP2D), safety and tolerability will     be further evaluated in an expanded cohort of subjects with pancreatic or lung cancer, as     monotherapy or in combination with the standard of care treatment. In addition, early signs     of efficacy during treatment with CAN04 will be investigated.   "
256311|NCT03263338|"     The purpose of this research study is to see if we can help parents to get their children to     go to bed earlier. This may help children to improve their sleep. The study will use a     web-based study platform and an activity monitor.   "
256312|NCT03268616|"     The most significant pathophysiology change of COPD patients is persistent incompletely     reversible airflow obstruction and increased lung volume. As a result, the work of     breathing(WB) and neural respiratory drive (NRD)increased. Noninvasive positive pressure     ventilation (NPPV) can reduce the load of respiratory muscles. Detection of NRD can be the     index of monitoring for titration of optimal level of ventilator support in the future. As     electromyography(EMG) is the most reliable measurement in evaluating NRD that can be used for     human. Currently the standard method for evaluation of NRD with EMG is using esophageal     multi-paired electrodes catheter(EMGdi) ,it is reliable but invasive .Surface respiratory EMG     (sEMG）is a noninvasive measurement. Although it subjected to contamination and less     sensitive, recently, advance in technology with multiple pair of surface electrodes is     possible to sufficient signals for evaluation of NRD.So the investigator compare the NRD     measured by EMGdi and sEMG,and consider that the correlation between them is well in     different levels.   "
256313|NCT03261167|"     Botulinum toxin A (GSK1358820) is a sterile, purified type A botulinum neurotoxin complex. In     Japan, 240 units of botulinum toxin A are approved as a maximum dose per administration for     upper limb spasticity. This study is planned to evaluate the effectiveness and safety of 400     units of botulinum toxin A which can help to increase the maximum dose per administration to     400 units from 240 units as the treatment with 240 units is considered insufficient in     subjects with post-stroke upper limb spasticity. Approximately 120 subjects will be     randomized to receive either 400 or 240 units of botulinum toxin A in double blind phase     followed by open-label phase in which 400 units of the study treatment will be injected in     both the groups. The study period will be up to 52 weeks, consisting of a screening phase up     to 4 weeks, minimum 12-week double blind phase (Part 1), maximum 36- week open-label phase     (12 weeks per cycle with 3 treatment phases: Part 2, Part 3 and Part 4).   "
256314|NCT03270930|"     Introduction Operative duration is an important but under-studied predictor of mortality in     emergency laparotomies.      Aims & Objectives The objective of this study was to quantify the effect of duration of     emergency laparotomy in children on mortality and to identify a rough cut-off duration of     laparotomy to serve as a guide to plan the laparotomy to optimize pediatric surgical patient     outcome.   "
256616|NCT02477839|"     The purpose of this trial is to assess the effectiveness and the safety of Lacosamide     administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for     children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled     partial-onset seizures.   "
256315|NCT03271177|"     The purpose of this study is to determine if the routine use of a sheathless 7F guide     catheter for transradial percutaneous coronary intervention (TR PCI) is non-inferior to a 6F     sheath/guide combination with regards to radial artery injury (radial artery     intimal-medial-adventitial thickening). To evaluate the radial artery, ultrahigh resolution     ultrasonography (55 mHz) will be used to accurately quantify radial artery     intimal-medial-adventitial thickness (IMT) at baseline and 90 days. A non-inferiority     analysis will be performed to compare the degree of radial artery IMT at 90 days between the     7F sheathless guide approach and the 6F sheath/guide combination.   "
256316|NCT03270410|"     This is a preliminary study whose objectives are to define the clinical use cases and the     constraints of the implementation of a multi-sensor image-sound system.   "
256376|NCT03267537|"     Insomnia is a common medical condition that has a deleterious effect on emotional status,     health-related quality of life, and has been associated with hospitalizations and all-cause     mortality. Recently hospitalized patients who are recuperating in their homes would find it     difficult to return for weekly visits with a clinical psychologist and therefore could     benefit from the convenience of CBT-I treatment administered in the comfort of their homes     via the wireless iPAD and video chat software. In patients who are recently discharged from     the hospital, we wish to assess whether telemedicine-based CBT-I is comparable to     conventional office-based CBT-I in the efficacy for treating insomnia. Research aiming to     improve understanding of whether insomnia represents a modifiable risk factor for     re-hospitalizations in patients who are high utilizers of healthcare services is an important     area of future research.   "
256317|NCT03258580|"     Background:      People can feel different levels of pain. This may depend on social, cultural, and biological     factors. These factors can also influence how people respond to each other, and how they     judge other people s experiences. Researchers want to learn more about these relationships.      Objective:      To study if social and cultural factors lead to differences in pain experience and how pain     is interpreted by other individuals.      Eligibility:      Healthy adults ages 18-60      Design:      Participants will have 1 or 2 visits.      Participants will be screened with a medical history and nursing assessment.      Participants may have the following:      Electric shock through small sticky pads on the arm, leg, or foot.      Thermal stimulation. A device called a thermode will be placed on the arm, leg, or foot. A     computer controls the thermode temperature.      Lowering their hand into very cold water.      Videos or pictures of the face will recorded while participants get painful stimulation.      A test to record heart electrical activity. Small metal disc or sticky pad electrodes will be     placed on the chest.      Pulse rate and breathing measured. Sweating will be measured with two small sensors stuck on     the hand.      A test to measure the electrical activity of facial muscles. Small metal disk or sticky pad     electrodes will be attached to the skin.      Viewing pictures and/or videos of other people who get painful and nonpainful stimulation.      Participants will make decisions about the images. They will respond by keyboard, mouse, or     button.      Eye tracking. A camera will measure participants pupil size and follow their eye movements.   "
256318|NCT03258606|"     Background:      Many medical conditions such as Alzheimer s disease limit the ability of people to think     clearly. For medical scientists to best study these medical conditions, they need to enroll     some people who may not be able to consent to participate in research on their own. Before     these individuals enroll in research it is important to assess whether they are able to     consent or whether someone else will need to consent for them. The NIH Clinical Center has a     team that performs these assessments. A team like this can be useful for two reasons. First,     it helps to protect the rights of research participants. Second, it makes it possible to     study medical conditions that could not be studied otherwise. In this study we will look back     at the records of the NIH Clinical Center team to review the process and results of these     assessments. We expect to learn how the capacity assessments were done. We will learn what     factors make people more or less able to consent. We will learn who consented for the     research participants when they could not consent on their own, for example a spouse or an     adult child. These results are likely to be useful to other researchers who wish to study     diseases that limit cognitive ability.      Objective:      To study the process and outcomes of capacity assessments of people who may not be able to     consent to research.      Eligibility:      People of all ages, genders, races, ethnicities, and languages whose ability to consent was     assessed at the NIH Clinical Center at some time during the years 1999-2016.      Design:      This study will only review existing records. There will not be any active participants.      Records will be reviewed for research only. This will take place in the Clinical Center. It     will be done by staff of the Department of Bioethics and the Human Subjects Protection Unit     (HSPU).      The study will collect data from the Bioethics Consult database. It will also collect data     from HSPU records.      Researchers will look at demographic data. They will look at details of capacity evaluations.      Personal data will not be extracted from existing records.   "
256319|NCT03258567|"     Background:      The drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can     slow the growth of other cancers. They want to study its effects on cancers that may have not     responded to chemotherapy or other treatments.      Objectives:      To see if Nivolumab slows the growth of some types of cancer or stops them from getting     worse. To test the safety of the drug.      Eligibility:      People 12 and older who have Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders     or EBV-positive non-Hodgkin lymphomas with no standard therapy      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      CAT scan of the chest, abdomen, and pelvis      Tumor and bone marrow biopsies (sample taken)      Magnetic resonance imaging scan of the brain      Lumbar puncture (also known as spinal tap)      Positron emission tomography/computed tomography scan with a radioactive tracer      Every 2 weeks, participants will get Nivolumab by vein over about 1 hour. They will also     have:      Physical exam      Blood and pregnancy tests      Review of side effects and medications      During the study, participants will repeat most of the screening tests. They may also have     other biopsies.      After stopping treatment, participants will have a visit every 3 months for 1 year. Then they     will have a visit every 6 months for years 2-5, and then once a year. They will have a     physical exam and blood tests.   "
256320|NCT03258593|"     Background:      Acalabrutinib and vistusertib are drugs that might block proteins that help blood cells     cancers live and grow. They may be able to help people with certain B-cell cancers.      Objective:      To test if the combination of the drugs acalabrutinib and vistusertib is safe and effective     in treating people with relapsed/refractory B-cell malignancies.      Eligibility:      People ages 18 and older with B-cell cancer that has not responded to prior treatment or come     back after treatment      Design:      Participants will be screened with:      Medical history      Physical exam      Bone marrow biopsy and aspiration: A needle is inserted into the bone to remove marrow.      Imaging scans. They lie in a machine that takes pictures of the body. They may be injected     with a radioactive substance.      Blood, urine, and heart tests      Tissue samples or optional biopsies: A small piece of tissue is removed.      Participants will be treated in 28-day cycles. They will take acalabrutinib twice a day by     mouth every day. They will take vistusertib either every day or they will take it for 2 days     and then skip 5 days through each cycle. They will take it twice a day by mouth. They will     keep a drug diary.      Participants will have visits about weekly for the first cycle, then every 2 weeks for cycles     2 6, and then once per cycle. They may have additional visits. Visits include blood, urine,     and heart tests, and repeats of other screening tests at certain visits.      Participants can be treated for up to 14 months.      Participants will have a follow-up visit 3 months after stopping treatment. Then they will be     contacted every 3 months.   "
256806|NCT00810264|"     The objective of this study is to confirm the long-term safety and reliability of the Corox     OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a     registry documenting the post approval clinical experience of these leads be designed and     implemented.   "
256494|NCT02890355|"     This randomized phase II trial studies how well modified irinotecan hydrochloride, leucovorin     calcium, fluorouracil (FOLFIRI) and veliparib as a second line of therapy work compared to     FOLFIRI in treating patients with pancreatic cancer that has come back after a period of     improvement (metastatic). Drugs used in chemotherapy, such as irinotecan hydrochloride,     leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It is not yet known whether modified FOLFIRI and veliparib as second     line therapy is more effective than FOLFIRI alone in treating metastatic pancreatic cancer.   "
256321|NCT03270449|"     Fibromyalgia (FM) is a multi-factorial chronic pain condition characterized by fluctuating     and heterogeneous symptoms. This leads to both reduced patient function and quality of life     and consequentially, significant economic burden on the society. Although numerous     pharmaceutical and multi-treatment approaches exist, there is lack of an integrated     multidisciplinary model of care for these patients. Such a system is hypothesized to be     beneficial for the patients and would help them regain function and significantly improve     their quality of life. The primary aim of this pilot clinical trial is to evaluate the     effectiveness of an integrated community-based multidisciplinary model of care for FM     patients in Penticton and surrounding areas. The comprehensive 10 week intervention will     provide care from a team of health care providers (psychiatrist, physiotherapist, certified     exercise therapist, dietitian, rheumatologist, and mental health clinician). Patients will     also attend a peer led pain self-management support group provided by the Arthritis Society.     The study aims at educating these patients about self-management of their symptoms such as     chronic pain, weight, sleep and mood disorders. The integration of health care between the     different providers will be achieved by huddle sessions that will be conducted on a monthly     basis. The evaluation of the study outcomes will be based on the RE-AIM framework. Data will     be collected through patient questionnaires, healthcare utilization data, and interviews with     providers. Data analysis will involve thematic analysis of qualitative data and statistical     methods for quantitative data.   "
256322|NCT03270137|"     Randomized clinical trial, comparative and single blind aims to determine effects on     cognition, psychological and behavioral symptoms and functionality of 5 Hz repetitive     transcranial magnetic stimulation (rTMS) administered over left dorsolateral prefrontal     cortex (lDLPFC) compared to six regions protocol, divided in two sub-conditions: day 1 (Broca     area, Wernicke area and lDLPFC) alternated by day 2 (left and right parietal association     cortex, and right dorsolateral prefrontal cortex [rDLPFC]). Main outcomes will be evaluated     at ending of 15 rTMS sessions and 4 weeks after.   "
256323|NCT03259737|"     The intention is to study presumed changes in daily practice, probably due to New Guidelines     concerning stroke patients. The impression is more frequent measurements of blood pressure,     serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging.   "
256324|NCT03263026|"     This randomized, placebo-controlled phase 3 study is planned to enroll approximately 235     treatment-naïve subjects with high-risk Diffuse Large B-Cell Lymphoma (DLBCL). Subjects will     be randomized 1:1 to R-CHOP plus enzastaurin or R CHOP (plus placebo during induction). All     subjects will receive up to 6 cycles (3 weeks per cycle) of treatment. PET/ CT will be used     to assess radiographic response at the end of treatment. Each subject's treatment assignment     will be unblinded after initial phase of treatment. Subjects randomized to the enzastaurin     arm who have a response will be offered maintenance treatment of the study drug for up to 2     additional years.   "
256325|NCT03255031|"     Background:      A ketogenic diet (KD) is high in fat and low in carbohydrates. Research has shown that a KD     can lessen tremor in animals withdrawing from alcohol. KD can also help people who have     difficulties with thinking, sleep, and mood. Researchers want to see if KD can lessen     symptoms of alcohol withdrawal in people with alcohol use disorder.      Objective:<TAB>      To test the effects of a ketogenic diet on alcohol withdrawal symptoms.      Eligibility:      Adults 18 years or older who are moderate or severe alcohol drinkers and are seeking     treatment for alcohol use. They must be in the NIAAA inpatient alcohol treatment program.      Design:      Participants will be screened under another protocol. They will have a medical and     psychiatric history, physical exam, and blood and urine tests. Participants will have a     breath test for alcohol.      The study will be done in a 3-week stay in the clinic.      Participants will get either a KD or Standard American diet.      Participants will have breathalyzer, blood, and urine tests.      Participants will have magnetic resonance imaging (MRI) scans. The scanner is a cylinder in a     magnetic field. They will lie on a table that slides in and out of the cylinder. They will do     tasks on a computer during the scan.      Participants will have tests of thinking, memory, and attention.      Participants will have their sleeping and waking measured. They will wear a device like a     headband held in place with elastic straps. Several electrodes will be placed on the body.      Participants will have heart tests.      Participants will wear an activity monitor on the wrist.      After the clinic stay, participants will be called by phone about 5 times over 3 months.   "
256326|NCT03255018|"     Background:      B-cell lymphoma is a cancer of white blood cells that are found in lymph nodes. Some kinds of     these cancers, such as gray-zone and extra-nodal, are rare and often aggressive. They are     usually resistant to current treatments. Researchers want to see if a drug called     pembrolizumab may treat these types of lymphoma.      Objective:      To collect data to see if it may be effective to give pembrolizumab to people with certain     types of rare, aggressive B-cell lymphomas.      Eligibility:      People ages 14 and older who have a B-cell lymphoma, including gray-zone lymphoma or     extra-nodal lymphoma      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Scans. They will lie in a machine that takes images.      A tissue sample from a previous procedure will be tested.      The study will be done in 21-day cycles. During the study, participants:      Will repeat the screening tests.      Will get the study drug as an infusion into a vein over about 30 minutes.      Will have a cheek swab and/or saliva sample collected.      May have a bone marrow aspiration. A needle will be put into the hipbone, and a small amount     of bone marrow will be taken out.      May have a lumbar puncture. If cerebrospinal fluid is collected, researchers will study it.      May have an eye exam.      May provide tissue samples.      May have tumor samples taken.      Participants will have a visit about 30 days after the last dose of the study drug. They will     then have 4 visits in year 1, 2 visits a year in years 2 5, and once each year thereafter.     They will also be contacted by phone.   "
256338|NCT03250741|"     This is phase IIa 24-week, prospective, randomized, double-blind placebo controlled study.     The study is designed to evaluate the efficacy, safety, and tolerability of transdermal patch     of Rotigotine (RTG) versus placebo (PLC) as add-on therapy with AChEI in patients with mild     AD according to the consensus diagnostic criteria and MMSE score of ≥18 and ≤24 at screening.     Two groups of patients with mild AD will be involved (50 patients each). One group will be     assigned to treatment with RTG 4 mg and the other one to PLC as add on to AChEI therapy     (Rivastigmine). Clinical and neurophysiological measurements will be collected before and     after drug administration.   "
256327|NCT03253705|"     Background:      This study is designed to provide samples to help us study the genes your blood cells are     making as well as the proteins, sugars, fats, vitamins and other metabolites found in your     blood or urine. Blood samples may also be collected to make special cells. These are called     induced pluripotent stem cells or iPSCs. Pluripotent stem cells are cells that can be     converted into any type of cell. Researchers want to study in the lab iPSCs that are derived     from blood samples.      Objective:      To collect samples to help study genes, proteins, sugars, fats, vitamins, and other     metabolites found in blood or urine.      Eligibility:      Healthy volunteers and patients ages 18 and older      Design:      First-time research study participants at NIH will have an initial visit for this study that     should last no more than 1 hour. All other visits should last 20 30 minutes.      Participants will undergo a limited history and physical exam.      Participants may have routine blood and urine tests.      If participants are giving a blood sample, they must have a hemoglobin level checked in the     past 12 months to make sure it is safe for them to give a blood sample for research.      Participants may have a venous blood collection. They may do this at several visits. They     will lie on a recliner or couch or sit in a chair. A needle will be placed into a vein in the     hand or arm, using sterile techniques. Blood will be withdrawn into multiple syringes or     tubes.      Participants may be asked to provide urine in an appropriate container   "
256328|NCT03253744|"     Background:      Prostate cancer is the second leading cause of cancer death in U.S. men. Radiation is an     effective treatment for most patients with localized prostate cancer, but sometimes the tumor     returns. Researchers want to see if a highly focused type of radiation can help. It is given     in only 5 treatments. It is called stereotactic body radiation therapy (SBRT).      Objective:      To study the maximum tolerated dose and side effects of stereotactic body radiation therapy     in people with a local recurrence of prostate cancer after radiation.      Eligibility:      Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no     evidence of distant metastatic disease      Design:      Participants will be screened with blood tests, physical exam, and medical history. They may     also have:      Magnetic resonance imaging (MRI) scan of the prostate..      PET/CT scan. Participants will get an injection of 18F-DCFPyL for the PET scan. They will lie     very still on their back on the scanner table.      Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum     to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate     at the same time to help guide the radiation.      About 2 weeks later, participants will have a radiation treatment planning CT scan.      Participants will answer questions about their urine function, bowel function, erectile     function, and mood.      Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks.      Participants will have follow-up visits. They will have a physical exam, blood tests, and     questionnaires.      Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated....   "
256329|NCT03268642|"     This is a retrospective cohort study to assess the clinical outcome of patients with     fulminant myocarditis using Life-support Based Comprehensive Treatment Regimen and     conventional therapy. In the present study, participants receive various treatment as part of     routine medical care without any assignment of specific interventions to them. The process of     treatment during hospitalization were recorded in medical chart and was reviewed by     independent research personnel.   "
256330|NCT03253718|"     Background:      The Human Motor Control Section does tests for people with movement disorders. In order to be     sure when a test is normal or abnormal, normal values must be determined in a large group of     healthy volunteers (HVs). Therefore, the researchers want to study the techniques in HVs.     They will use the results as the standard of comparison in future clinical studies.      Objective:      To get enough normal results in movement tests to use in clinical studies.      Eligibility:      Healthy adults ages 18 68      Design:      Participants will be screened with medical history and physical and neurological exams.      Participants will have 1 or 2 visits. They may have:      Small sticky electrodes attached to the skin on the hands/arms and neck. These will measure     muscle activity.      Tiny shocks given to a finger. Participants will be asked if they felt 1 or 2 shocks. This     will be done to each hand over about 30 minutes total.      A questionnaire about anxiety.      Acoustic startle reflex test. Small electrodes will be stuck to the eye, hand, and leg.     Sensors will be stuck to the palms. Small metal electrodes on the chest and inner arm will     measure heart rate. Participants will wear headphones. Once everything is in place,     participants will hear a low sound for about 10 minutes. They will hear a short louder sound     every 45 60 seconds.   "
256331|NCT03253692|"     Background:      CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed     tomography angiography. It uses scanning to look at the arteries that supply blood to the     heart. It is noninvasive, widely available, and generally accurate. But it does expose people     to radiation. Exposure to high amounts of radiation can increase a person s risk of getting     cancer. Researchers want to learn more about the relationship between CCTA and radiation     exposure.      Objective:      To see how much radiation is used to take pictures of the heart and how measures to reduce     radiation are used around the world.      Eligibility:      People ages 18 years and older who need a computed tomography (CT) scan of the heart      Design:      Participants will be screened with a review of their medical records.      Participants may have a pregnancy test.      Participants will have the scheduled scan. Small, sticky discs will be placed on the chest. A     small tube will be placed into a vein in the arm. A contrast material (dye) will be given     through it. Participants will lie on the CT scanning table.      A CCTA scan usually takes about 15 minutes if the heart rate is slow and steady.   "
256339|NCT03270163|"     Intensive care unit acquired muscle weakness (ICUAW), a common disease characterized by     damage to the peripheral nervous system and/or muscles, is a serious condition with     significant morbidity and mortality.      The diagnosis of ICUAW is difficult and often delayed, because based upon clinical assessment     of muscle strength (MRC score), requiring patients to be awake and cooperative.      Transcutaneous electrical stimulation consists in applying electrical stimulation along a     motor nerve in order to generate muscle contraction. The mechanical response thus generated     is recorded, which allows to appreciate the generated muscular strength. This noninvasive     procedure, which can easily be performed at the bedside, could represent an interesting tool     to evaluate muscle strength, in ICU patients under deep sedation.   "
256332|NCT03253731|"     Background:      The two hemispheres of the brain are connected. Changes in one hemisphere affect the other     through this connection. Research has shown that training new skills in one hand improves the     same skills for the other hand. Researchers want to learn more about how the brain works to     transfer the skills to the other hand.      Objective:      To learn how changes on one side of the brain affect the other side. To study the activity of     the left and right sides of the brain in healthy adults.      Eligibility:      Healthy volunteers ages 18-55 years old who are right-handed.      Design:      Participants will be screened with a medical history and physical exam. They will complete a     questionnaire about their handedness. This may be done on paper or on a computer.     Participants may have urine pregnancy tests.      Participants will have 2 study visits.      Participants will have a structural magnetic resonance imaging (MRI) scan. MRI uses a strong     magnetic field and radio waves to take pictures of the brain. The scanner is a metal cylinder     in a strong magnetic field. Participants will lie on a table that slides in and out of the     cylinder.      Participants will have transcranial magnetic stimulation (TMS). Two wire coils will be placed     on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse     that affects brain activity. Participants may be asked to tense certain muscles or do simple     tasks during TMS.      Participants will have electromyography. Small sticky pad electrodes will be attached to the     skin on the hands. Muscle activity will be recorded during the TMS procedure.   "
256333|NCT03253796|"     The purpose of this study is to evaluate the effect of treatment withdrawal vs continued     treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence     of a flare in non-radiographic axial spondyloarthritis over up to 12 months. The primary     hypothesis is that continued treatment with golimumab is superior to treatment withdrawal,     based on the percentage of subjects without a flare during up to 12 months of blinded     therapy.   "
256334|NCT03251989|"     Background:      Ependymoma is a rare type of primary brain or spine tumor. That means that it starts in the     brain or spine. These tumors affect both children and adults. Researchers want to study a     large group of people with this kind of tumor. They want to learn more about the tumors,     including the risk factors related to how they develop in adults.      Objective:      To collect health and gene data to learn about what changes are associated with an     ependymoma, to eventually screen for these changes or target the genes in treatment.      Eligibility:      People 18 years and older who have an ependymoma tumor      Design:      Participants will be recruited from a research website and a previous study.      Participants will take an online study. It is called the Adult Ependymoma Outcomes Survey. It     should take about 15 20 minutes. Participants will be asked for demographic data and about     their disease history.      Participants will take another online study. It is called the Adult Ependymoma Risk Survey.     It should take about 50 minutes. Participants will be asked about:      Demographic data      Personal medical history      Family medical history      Environmental exposures      Participants who have physical problems can have help with the surveys and forms.      Participants will get a kit in the mail with the materials needed to collect saliva.     Participants will ship the sample to the study team in a prepaid envelope.      If the sample is not usable, participants may be asked to give another one.   "
256335|NCT03270865|"     The purpose of the study Usability and Ergonomic Evaluation of Self-Positioning System for     Retinal Imaging is to enable self-operation of a monitoring device in home-simulated     environment   "
256336|NCT03248622|"     Background:      Treatment of some diseases can suppress the immune system. This can cause other conditions to     reactivate. Recent cases have shown that hepatitis B virus (HBV) reactivates in people who     had already recovered from it during treatment for chronic hepatitis C (CHC). Their treatment     was direct-acting antiviral (DAA) agents. Researchers want to see how common this     reactivation is. They want to learn what the effects are. They will study data that have     already been collected.      Objectives:      To study HBV reactivation in people with CHC and resolved HBV infection who are being treated     with interferon-free DAA-based therapy.      Eligibility:      Data were collected from adults 18 and older in studies that were done in 2012 and 2016.      Design:      Researchers will screen the records from the previous studies. They will identify     participants who had HBV infection before they got DAA-based treatment.      Researchers will take data from those records. This will include data on:        -  Age, sex, race, and ethnicity        -  Treatment and disease status        -  Lab results      Researchers will test stored samples. They will test samples that were taken before, during,     and after treatment. They will check if HBV was reactivated. They will also check if other     clinical outcomes occurred.   "
256337|NCT03248635|"     Background:      The Division of Cancer Epidemiology and Genetics does research into the causes of cancer and     ways to prevent it. It uses data from questionnaires. Sometimes, pre-testing a questionnaire     with a group of volunteers can help researchers find errors in it and learn ways to improve     it.      Objectives:      To test a questionnaire for problems that might cause response errors and to develop ideas     for improving it. To test how long it takes people to complete it.      Eligibility:      Adults ages 35-75. Volunteers both with and without a history of tobacco use and with or     without a family history of cancer are needed.      Design:      Participants will be screened with a phone call.      Participants will be told what background data to bring to the 1 study visit.      An interviewer will give the participants the questionnaire. It will be done with pen and     paper. It will take about 1 hour.      There will be multiple-choice and open-ended questions. They will be about lifestyle,     medical, and environmental factors. Some of the questions will be about possibly illegal or     highly sensitive behaviors.      Participants will note any questions that they find hard to answer for any reason. They will     be asked to answer the best they can, but they can skip any question that they prefer not to     answer.      The personal data of participants will be deleted when the study is done.      The interviewer will observe participants while they do the questionnaire. He or she will     look for things like long pauses and confusion.      Participants will discuss the exam with the interviewer after they finish. This will take     about 1 hour.   "
256340|NCT03266900|"     The investigators would like to compare the progression free survival, overall survival,     quality of life, and safety outcomes of patients receiving versus not receiving a 2nd     transurethral resection of bladder tumor.   "
256343|NCT03239899|"     Background:      HIV affects millions of people. The disease may hide in the brain, even in people with     well-controlled HIV without cancer. Then it may wake up and continue. The drug     pembrolizumab uses the body s immune system to fight cells like cancer cells. It is approved     to treat some cancers but not HIV. Researchers want to see if it is safe for HIV-positive     people without cancer. This study is not for HIV treatment; only one dose of the drug will be     used.      Objective:      To learn if the drug pembrolizumab, used to treat certain cancers, is safe for HIV-positive     people.      Eligibility:      Adults ages 18 and older with HIV who are in another NIH protocol      Design:      Participants will be screened with:        -  Medical history        -  Physical and neurological exams        -  Blood tests        -  Lumbar puncture. The lower back will be numbed. A needle will remove fluid from between          back bones.        -  FDG-PET/CT. A radioactive sugar will be injected in a thin plastic tube (catheter)          inserted in an arm vein. Participants will rest for an hour, urinate, then lie in the          scanner. A mask will hold the head still.      Women who can become pregnant cannot take pembrolizumab. Men who take it must use 2 kinds of     contraception.      Participants will have up to 7 more visits, which repeat some screening tests.      At 1 visit, participants will get one dose of pembrolizumab by catheter for 30 minutes. They     will get allergy and pain medicines.      At 2 visits, participants will have a brain MRI. They will get a contrast agent by catheter.     They will lie in a metal cylinder that takes pictures for 1-2 hours. They will get earplugs     for loud sounds.   "
256344|NCT03239145|"     This research study is studying an investigational combination of drugs as a possible     treatment for advanced solid tumors: melanoma, ovarian, renal, or colorectal cancer.      The drugs involved in this study are:        -  Pembrolizumab        -  AMG386   "
256345|NCT03242122|"     The study is open-label with a randomized, cross-over design using standard Gl methodology.   "
256346|NCT03233724|"     Background:      Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Lung cancer is the     leading cause of cancer-related death in the United States. Most people with lung cancer are     already in the advanced stages of the disease by the time they see a doctor. Researchers want     to see if combining an approved drug with two new drugs can help.      Objective:      To study if tetrahydrouridine-decitabine (THU-DAC) with pembrolizumab is safe and effective     in people with non-small cell lung cancer that cannot be removed by surgery.      Eligibility:      People 18 years and older who have NSCLC that cannot be removed by surgery      Design:      Participants will be screened with        -  Medical history        -  Physical exam        -  Blood and urine tests        -  Tests of heart and lung function      They may have a small tumor sample taken (biopsy). They may have tumor scans.      Before starting treatment, participants will repeat the screening tests. They will also give     a stool sample.      The study will be done in 3-week cycles for up to 6 cycles.        -  Participants will take the 2 study drugs by mouth 3-5 days a week.        -  Participants will get pembrolizumab in a vein for 30 minutes 1 day each cycle.      Participants will keep a study medication diary.      During cycle 1, participants will have blood taken multiple times on days 1 and 2.      Every 3 cycles, participants will repeat screening tests.      Participants will have a mandatory tumor biopsy.      When they finish treatment, participants will have a physical exam and blood tests.   "
256347|NCT03231943|"     Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat     throughout the world and development of medicines with new mechanism of action have an     important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in     HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will     collect information on safety, tolerability and drug levels in the body of in healthy     subjects for GSK3640254. The information collected in this study will help in further     clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in     HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single     oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be     randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be     given immediately after a moderate fat meal. Maximum duration of study participation will be     approximately 12 weeks.   "
256348|NCT03225183|"     Background:      The Framingham Heart Study (FHS) was initiated by the U.S Public Health Service in 1948 and     turned over to the newly established National Heart Institute in 1951. The FHS is now jointly     led by the National Heart, Lung, and Blood Institute and Boston University. The FHS currently     studies risk factors, and the genetics of heart and blood vessel disease, and other health     conditions in three generations of study participants. Scientists want to use the data     collected from this study to do more research. They want to use a technique that determines     the sequence of ribonucleic acid (RNA) molecules.      Objective:      To study genes related to certain diseases and health conditions. These include heart and     blood vessel diseases, lung and blood diseases, stroke, memory loss, and cancer.      Eligibility:      People in the FHS Third Generation cohort who already attended exam 2.      Design:      Researchers will study samples that have already been collected in the FHS. There will be no     active examination or burden to participants. During FHS visits, participants gave blood     samples. They gave permission for the blood to be used for genetic research. RNA will be     generated from the samples. They will be given a new ID separate from any personal data. They     will be stored in a secure FHS lab. The samples will be analyzed. Only certified researchers     can access them.      No study participants will be contacted in relation to this project.   "
256495|NCT02891382|"     This feasibility study aims to compare the implementation process of three different     interventions that use economic incentives to promote lifestyle behavioral changes in     patients with type 2 diabetes mellitus, and to identify barriers and facilitators linked to     the process of implementing each of the interventions. The interventions are based on     economic incentives directed to the patient (individual incentives) or a team comprised by     the patient and a partner (mixed incentives).      Design: Three-month randomized control feasibility study to test the feasibility of     implementing three types of intervention with economic incentives in patients with diabetes     mellitus.      Setting: Diabetes outpatient clinics from a public hospital in Peru.   "
256496|NCT02920177|"     The purpose of this study is to compare the clinical response of intra-articular platelet     rich plasma (PRP) versus corticosteroid injection in patients affected by femoroacetabular     impingement (FAI).   "
256349|NCT03225144|"     Objectives      The primary objective is to screen patients who are referred with a diagnosis of     frontotemporal dementia, motor neuron disorder, or related adult-onset neurodegenerative     disorder to assess patient eligibility for ongoing protocols. The secondary objective is to     develop and maintain a registry of characterized patients who may be eligible for future     trials. An exploratory objective is to obtain biospecimens from clinically characterized     patients to carry out laboratory-based studies aimed at understanding the molecular pathways     and genetic overlap between these neurodegenerative disorders.      Study population      Adults referred with clinical diagnoses of frontotemporal dementia, motor neuron disorder, or     related adult-onset neurodegenerative disorder.      Design      Participants will all undergo diagnostic screening tests, a standard battery of tests to     measure cognitive and motor function, and blood for clinical testing and research. Additional     diagnostic and research testing, including magnetic resonance imaging, electromyography,     neuropsychological testing, lumbar puncture, and skin biopsy will be obtained in selected     patients.      Outcome measures      Patients will be screened for eligibility for current research protocol or entered into a     registry future research protocols   "
256350|NCT03225157|"     Background:      Cisplatin is a chemotherapy drug. It is used to treat head and neck squamous cell carcinoma     (HNSCC) and other cancers. It can cause hearing loss for some people. It is not known how     many people will get hearing loss from cisplatin. It is also not known what other factors     might influence who gets hearing loss. Factors could include age, sex, noise exposure, and     other drugs the person is taking. Statins are drugs used to lower cholesterol. Statins may     also reduce cisplatin-induced hearing loss.      Objectives:      To see if statins reduce hearing loss in people getting cisplatin therapy to treat HNSCC. To     find out how many people taking cisplatin get hearing loss from it. To find out if other     factors might influence whether cisplatin causes hearing loss.      Eligibility:      People ages 18 and older who are getting treatment with cisplatin for HNSCC      Design:      Participants will be screened with a review of their medical records.      Participants will have 3 visits. These will be before the onset of cisplatin therapy, at     about 4 weeks after they finish therapy, and about 6 months after they finish therapy. Each     visit will include:      Medication history      Audiogram/hearing tests. Participants will wear headphones and indicate when they hear     different sounds.      Questions about their noise exposure history and whether they have ringing in the ears   "
256351|NCT03225170|"     Background:      Some women with breast cancer and ovarian cancer are genetically predisposed to them. This is     called hereditary breast and ovarian cancer (HBOC). The women have to make hard choices about     tests and treatment. Researchers want to study the best way to guide them. A kind of writing     exercise might help if it is done before genetic counseling. It is called a self-affirmation     (SA) exercise. It may lead to better communication in the counseling and better behavioral     outcomes.      Objective:      To test if an SA exercise done with HBOC genetic counseling could improve client     communication and behavior.      Eligibility:      Adults ages 18-90 with an appointment at the HBOC clinic at St. Luke s Health System      Adults ages 18-90 who are genetic counselors with breast and ovarian cancer clients      Design:      Appointment participants will be screened by phone.      They will arrive 15 minutes early to their appointment.      They will do a 10- to 15-minute survey and writing exercise. This includes questions about:      If they have cancer      If they have had or were offered genetic counseling      Things that are important to them      After the appointment, they will take a 10- to 15-minute follow-up survey. It can be in the     office or online. It includes questions about how they felt about the writing exercise and     their counseling.      Counselor participants will take a 2- to 5-minute survey after sessions with clients in the     study. This includes questions about how the client was in the session. They will take a 10-     to 15-minute survey at the end of the study. It will be about their opinions of the writing     exercise.   "
256352|NCT03225196|"     Background:      Extracellular RNAs (exRNAs) send genetic data from cell to cell. This is how they affect the     way cells communicate with each other. There are many types of exRNA, and they each serve     different roles. But they have also been linked to some diseases. Researchers want to measure     exRNAs to see how they relate to certain traits over time. They will use blood samples that     were taken as part of the Framingham Heart Study (FHS).      Objectives:      To identify cross-sectional associations of exRNAs with age, sex, and cardiometabolic risk     factors.      Eligibility:      People ages 30-70 who had blood taken as part of the FHS Third Generation cohort.      Design:      Researchers will study samples that have already been collected in the FHS. There will be no     active participant contact for this project, only use of data that are collected as part of     planned follow up from other studies.      As part of the FHS, participants gave blood samples. They gave permission for the blood to be     used for research.      The exRNAs from the blood samples will be studied to see how they relate to certain traits.     These include age, sex, and body mass index.      The exRNAs will also be studied for their usefulness as biomarkers of risk for subclinical     atherosclerotic cardiovascular disease.      No study participants will be contacted for this study.   "
256359|NCT03216707|"     Brain stimulation is a technique that can alter cortical function and thus be suitable for     treating pain. This is especially when pain is chronic and associated with functional and     even structural reorganization of the central nervous system. The idea of using invasive and     noninvasive brain stimulation for pain relief is not new. Studies from the 1950s have     investigated the brain stimulation for therapeutic use. Direct implantation of electrodes on     the cerebral cortex has been carried out by Tsubokawa and colleagues in Japan. Although     reported to be effective, it is invasive and involves the implantation of a foreign body into     the cranium. Recent advancements in the techniques of non-invasive brain stimulation have     improved and have measurable modulatory effects making this an attractive alternative for     treating pain   "
256507|NCT02839707|"     This randomized phase II/III trial studies how well pegylated liposomal doxorubicin     hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian,     fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy,     such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. block tumor growth Monoclonal antibodies, such as atezolizumab     and bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not     yet known which combination will work better in treating patients with ovarian, fallopian     tube, or primary peritoneal cancer.   "
256353|NCT03223636|"     Background:      Little is known about the time it takes for nerve signals to go from one area of the brain to     another. Using advanced methods for brain research, researchers want to look at the time it     takes to send messages between different brain areas. They also want to develop new tests.      Objectives:      To develop tests to measure the sizes of nerve fibers in the peripheral nerve system and in     the brain. Also to find out the different speeds that information travels in nerve fibers.      Eligibility:      Healthy, right-handed people ages 18-70      Design:      Participants will be screened with medical history and a physical exam.      Participants will have up to 7 visits depending on the tests they choose. Visits last about     2-4 hours and may involve the following tests:        -  Physical exam        -  Urine tests        -  Magnetic resonance imaging (MRI). Participants lie on a table that slides into a          scanner. They will be in the scanner for up to 1 hour. For some scans, sensors are          placed on the skin. They will get earplugs for loud noises.        -  Small, sticky pads on the skin will electrically stimulate nerves in the forearm.        -  Transcranial magnetic stimulation (TMS). A wire coil will be held to the scalp. A brief          electrical current passes through the coil to affect brain activity.        -  Electroencephalography. TMS will be given to the brain. Small electrodes on the scalp          measure brain activity. Participants may do small tasks.        -  Electrodes on the scalp will send an electrical current to the brain.        -  A cone with magnetic detectors will be lowered onto the head to record brain activity.          Participants will perform various tasks.   "
256354|NCT03223623|"     Background:      Little is known about the problems in brain function in focal hand dystonia (FHD) or complex     regional pain syndrome (CRPS) dystonia. It is unclear why some CRPS patients develop dystonia     but others do not. Researchers want to learn which area of the brain is involved in CRPS     dystonia compared with FHD.      Objectives:      To understand why people with CRPS develop dystonia, and if these reasons are different in     people with FHD.      Eligibility:      Adults ages 18 - 70 with CRPS dystonia OR with CRPS without dystonia OR with FHD and Healthy     volunteers of similar age.      Design:      Participants will be screened with physical exam, neurological exam, and medical history.     They may give a urine sample and will answer questions.      Participants can have 4 - 5 outpatient visits or stay at the clinical center for     approximately 5-6 days.      Participants will have MRI scans. They will lie on a table that slides in and out of a     scanner that takes pictures of their brain. They will do small tasks or be asked to imagine     things during the scanning.      Participants will have transcranial magnetic stimulation (TMS) sessions for a few hours, with     breaks. A brief electrical current passing through a well insulated wire coil on the scalp     creates a magnetic pulse. This affects brain activity. Participants may do small tasks during     TMS.      Participants will have the electrical activity of their muscles measured during TMS sessions.     Small sticky pads will be attached to their hands and arms.      Participants ability to feel 2 separate stimuli as different will be tested by using a weak     electrical shock to their fingers. They will also be asked to feel small plastic domes with     ridges, that may cause discomfort.   "
256355|NCT03223610|"     Background:      B-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the     system that fights infections and disease. Researchers want to learn how certain drugs work     together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone,     obinutuzumab, and lenalidomide (ViPOR).      Objective:      To study the safety of ViPOR for people with B-cell lymphoma.      Eligibility:      People ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after     treatment      Design:      Participants will be screened with:        -  Medical history        -  Physical exam        -  Blood, urine, and heart tests        -  Tissue sample from previous procedure        -  Imaging scans        -  Registration for counseling on the risks of lenalidomide. They must get counseling at          least every 28 days.      Participants will have a bone marrow aspiration before treatment.      Participants may have tumor samples taken.      Participants will get ViPOR in 21-day cycles. For up to 6 cycles:        -  Participants will get one drug by IV on days 1 and 2.        -  Participants will take the other four drugs by mouth on most days. After their first          dose of venetoclax, they will stay in the clinic for at least 8 hours and return the          next day for monitoring. They may be admitted for more drugs or monitoring.      Participants will keep a drug diary.      Participants will have a physical exam and blood and urine tests at least once per cycle.     They will have scans 4 times over 6 cycles.      Participants will have a visit about 1 month after their last dose of study drug. They will     then have visits every few months for 3 years, and once a year for years 4 and 5. Visits     include a physical exam, blood tests, and scans....   "
256356|NCT03223662|"     Background:      The number of patients with esophageal cancer keeps rising. For many patients, a combination     of surgery, chemotherapy, and radiation is necessary to completely treat the disease.     Usually, patients receive chemotherapy and radiation at the same time followed by surgery to     remove the part of the esophagus with the tumor (Neoadjuvant chemoradiotherapy nCRT).     Researchers want to learn how to make this treatment more effective.      Objective:      To see if biopsies before treatment can show which patients will do the best with a     combination of chemotherapy, radiation, and surgery.      Eligibility:      Adults at least 18 years old with esophageal adenocarcinoma or squamous cell carcinoma who     should be treated with chemotherapy, radiation, and surgery.      Design:      Patients will undergo standard testing that is routine for all patients with this disease.     These tests include:      Medical history      Physical exam with activity and nutritional assessment      Standard lab tests      Imaging studies including a CAT scan and PET scan      Breathing test into a machine to measure size and function of lungs.      Biopsy for a small sample of tumor is removed by EGD: A tube inserted into the mouth under     anesthesia      Endoscopic ultrasound is performed in some but not all patients.      Patients will have nCRT at the clinic or with their local doctor.      In 6 -12 weeks after nCRT, patients will undergo surgery with:        1. A robotically-assisted, minimally-invasive esophagectomy        2. Or, a traditional, open approach.      After surgery, patients are usually in the hospital for 2 weeks and have a feeding tube for     at least 2 weeks and potentially longer until they are eating enough to not lose weight.      Patients will return for follow-up visits with labs and CAT scans every 6 months for the     first two years then every year afterwards.   "
256357|NCT03229252|"     28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult     subjects with cystic fibrosis.   "
256358|NCT03218436|"     Cervical intraepithelial neoplasia will be treated with physical low temperature plasma in     the plasma cohort compared to watchful waiting in the control cohort.      Primary endpoint after 3-6 months: Pathological remission.      Secondary endpoint: HPV remission.   "
256518|NCT02813798|"     The purpose of this study is to determine the effect of renal impairment on rivipansel.   "
256519|NCT02943460|"     The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in     adults with primary sclerosing cholangitis (PSC).   "
256360|NCT03221192|"     Nasal polyposis is a chronic inflammatory disease of the nose and sinuses. GlaxoSmithKline     (GSK) is embarking on a clinical program to assess treatment of severe, recurrent nasal     polyps with an anti-interleukin-5 (anti-IL5) (mepolizumab). Subject specific symptomatic     endpoints will form the basis for the assessment of treatment benefit of nasal polyp     therapies. However, there is a lack of published qualitative data regarding nasal polyps to     understand the symptoms or health-related quality of life (HRQoL) impacts. This     cross-sectional qualitative study aims to address this unmet gap by conducting     semi-structured combined concept elicitation (CE) and cognitive debriefing (CD) telephone     interviews and real-time data capture. The combined CE and CD interviews (each 90 minutes in     duration) will investigate the subject experience of nasal polyps, and the relevance and     understanding of existing patient-reported outcomes (PRO) instruments and the real-time data     capture, over a 10 day period, will investigate the subject experience of the symptoms, HRQoL     impacts and treatment of nasal polyps and any day-to-day variability that exists in these     experiences in 'real time'. Twenty adult subjects in the United States (US), and 10 adult     subjects in Germany with severe, recurrent nasal polyps will participate in the CE and CD     interviews section of the study and of these, 10 subjects from US will also complete     real-time data capture app task.   "
256361|NCT03206060|"     Background:      Pheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the     adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and     there are no good treatments if the disease has spread. Researchers think a new drug may be     able to help.      Objective:      To learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the     length of time it takes for the cancer to return.      Eligibility:      Adults who have an inoperable tumor of the study cancer that can be detected with     Ga-68-DOTATATE PET/CT imaging      Design:      Participants will be screened with a medical history, physical exam, and blood tests.      Eligible participants will be admitted to the NIH Clinical Center.      Participants will get the study drug in an intravenous infusion. They will get 4 doses, given     about 8 weeks apart.      Between 4 and 24 hours after each study drug dose, participants will have scans taken. They     will lie on their back on a scanner table.      Participants will have vital signs taken. They will give blood and urine samples.      During the study, participants will have other scans taken. Some scans will use a radioactive     tracer.      Participants will complete quality of life questionnaires.      Participants will be contacted by phone 1-3 days after they leave the Clinical Center. They     will then be followed every 3 to 6 months for 3 years or until their disease gets worse.   "
256362|NCT03206125|"     Background:      Esophageal cancer is a common cause of cancer deaths. Most cases of this cancer are     esophageal squamous cell carcinoma (ESCC). Many of these cases come from two parts of the     world with high-risk. One of these is in East Africa and include the country of Malawi.     Researchers want to learn what factors explain the high risk there so we can understand     better what causes this cancer in people everywhere.      Objective:      To learn more about causes and outcomes of esophageal squamous cell carcinoma using Malawi     because of the large number of cases in that country.      Eligibility:      Adults at least 18 years old who have ESCC and live in a certain region of Malawi      Adults in the same age group and location who do not have ESCC      Design:      Participants will be screened at a hospital in Malawi.      Participants will have a 1-hour interview. They will answer questions about:      Demographics (age, ethnicity, education)      Place of residence      Medical history and family medical history      Drug, alcohol, and tobacco use      Hot beverage consumption      Indoor air pollution      Occupation      Food habits      Farming      Gastrointestinal health      Participants will have their teeth and fingernails examined.      Participants will be asked to give samples of blood, urine, saliva, toenails, and for the     cancer cases, a small piece of their tumor.      Participants will have 4 phone calls a year for 2 years to ask about their health.   "
256363|NCT03206086|"     Background:      Fanconi anemia is a genetic disease. Some people with it have reduced blood cell counts. This     means their bone marrow no longer works properly. These people may need blood transfusions     for anemia (low red blood cells) or low platelet counts or bleeding. Researchers want to see     if a new drug will help people with this disease.      Objective:      To find out if a new drug, eltrombopag, is effective in people with Fanconi anemia. To know     how long the drug needs to be given to improve blood counts.      Eligibility:      People at least 4 years old with Fanconi anemia with reduced blood cell counts.      Design:      Participants will be screened with blood and urine tests. They will repeat this before     starting to take the study drug.      Participants will take eltrombopag pills by mouth once a day for 24 weeks. They will be     monitored closely for side effects.      Participants will have blood tests every 2 weeks while on eltrombopag.      Participants will visit NIH 3 months and 6 months after starting eltrombopag. At these     visits, participants will:      Answer questions about their medical history, how they are feeling, and their quality of life      Have a physical exam      Have blood and urine tests      Have a bone marrow sample taken by needle from the hip. The area will be numbed.      If participants blood cell counts improve, they might join the extended access part of the     study. They will continue taking eltrombopag for 3 years and sign a different consent.      After 24 weeks of treatment, if there is no improvement in blood cell counts, participants     will stop taking eltrombopag. They will return for an optional follow-up visit that repeats     the study visits.   "
256375|NCT03188419|"     Background:      People who have certain immune system diseases often need a procedure called allo HSCT. This     is short for allogeneic hematopoietic stem cell transplant. This might cure people with these     diseases. Many people who need allo HSCT need donors who are relatives with similar genes.     But the disease may also affect those in the donor pool. This may mean there are fewer     options for people with inherited diseases. Researchers want to collect data on how     transplant candidates and their donors are found.      Objective:      To find out how genetic diseases and the ways they are inherited affect the breadth of     options for allo HSCT donors.      Eligibility:      Records from studies that have already been done. These will be for people ages 4 and older     who were evaluated for allo HSCT or to be donors.      Design:      Participants already signed a consent form for their records to be shared.      Researchers will study the participant data.      Data will be stored in an electronic system. Researchers will use passwords to protect the     data.   "
256520|NCT02943447|"     The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in     adults with primary biliary cholangitis (PBC).   "
256364|NCT03206112|"     Background      Focal dystonia is a brain disorder. It affects a muscle or muscles in a specific part of the     body. Researchers think it may be related to excessive training or practice. They want to     know more about how much training might trigger focal dystonia.      Objectives:      To study why people develop focal dystonia. To study how brain plasticity changes with focal     dystonia.      Eligibility:      People ages 18 70 with focal dystonia.      Healthy volunteers the same age are also needed.      Design:      Participants will be screened with a physical exam and questions. They may have blood and     urine tests.      Participants will have up to 3 testing visits.      Participants will have small electrodes stuck on the skin on the hands or arms. Muscle     activity will be recorded.      Participants will have transcranial magnetic stimulation (TMS). A wire coil will be placed     onto the scalp. A brief electrical current will pass through the coil. The current will     create a magnetic field that affects brain activity.      Participants may be asked to tense certain muscles or do simple actions during TMS.      A nerve at the wrist will get weak electrical stimulation. The stimulation may be paired with     TMS for very short times.      Participants will receive repeated magnetic pulses. Participants will receive a total of 150     pulses during a 10-second period. An entire testing visit will last about 3 hours.   "
256365|NCT03270813|"     The purpose of this study is to evaluate the use of Regulate and Gain Emotional Control     (RAGE-Control), a biofeedback video game, in combination with brief instruction in relaxation     skills as an intervention for symptoms of anger and aggression in children and adolescents.     Half of the research participants will learn relaxation techniques and practice them using     the RAGE-Control videogame. The other half of the participants will learn relaxation     techniques and play a similar videogame without the biofeedback component. The investigators     hypothesize that participants in the RAGE-Control group will show a greater reduction in     symptoms of anger and aggression than those in the non-RAGE-Control group.   "
256366|NCT03204188|"     Background:      Chronic lymphocytic leukemia (CLL) is a cancer of white blood cells. It is also called small     lymphocytic lymphoma (SLL). It causes tiredness, night sweats, weight loss, swollen lymph     nodes, easy bruising or bleeding, and frequent infections. Researchers want to test if a drug     combination is effective and safe for people with CLL/SLL.      Objective:      To test how safe and effective a combination of ibrutinib, short-course fludarabine, and     pembrolizumab is for people with chronic lymphocytic leukemia (CLL), also known as small     lymphocytic lymphoma (SLL).      Eligibility:      Adults at least 18 years old who have CLL or SLL, with certain genetic changes.      Design:      Participants will be screened with:        -  Medical history        -  Physical exam        -  Heart tests        -  Blood and lab tests        -  Small lymph node sample removed by needle        -  Sample of bone marrow taken by needle in the hipbone. The area will be numbed.        -  CT or PET scan. They will lie in a machine that takes pictures. They may have a          radioactive sugar injected before the scan.        -  Pregnancy test      Phase 1 will be 12 weeks. Participants will take ibrutinib by mouth once a day. For weeks 5     and 9 they will also take fludarabine. It will be infused in a vein for half an hour each day     for 5 days in a row.      Phase 2 will be 2 years. Participants will take ibrutinib by mouth once a day. They will also     get pembrolizumab by vein for half an hour once every 3 weeks.      After that, the study team will decide if participants should continue therapy.      During the study, participants will have regular visits. They will repeat some or all     screening tests.   "
256367|NCT03205228|"     A randomized controlled trial study is conducted to compare treatment efficacy between     psycho-education, anxiolytics drug and proton pump inhibitors in participants who met the     criteria of globus.   "
256368|NCT03197025|"     Background:      Vulvar high-grade squamous intraepithelial lesion (HSIL) is caused by infection of the vulva     with human papillomavirus (HPV). In a small percentage of cases, vulvar HSIL can turn into     cancer. The risk of cancer can be reduced by treating HSIL. A personalized immune treatment     might rid the body of HPV infection and thereby cure vulvar HSIL. The immune treatment in     this study is called T cell therapy. The cells are E6 TCR T cells. Participants will also get     aldesleukin (IL-2) to help the cells last longer.      Objective:      To find a safe dose of E6 TCR T cells combined with aldesleukin to use in people with vulvar     HSIL.      Eligibility:      Design:      Participants will be screened with:      Physical exam      Medical history      Blood, lab, and pregnancy tests      Heart tests      Chest x-ray      Sample of tissue taken from the vulva (biopsy).      Participants will have leukapheresis. Blood will be removed by a needle in one arm. A machine     removes white blood cells from the blood. The rest of the blood is returned by needle in the     other arm. The white blood cells will be changed into E6 TCR T cells and grown in a lab.     About 3 weeks later, participants will be admitted to the hospital for about 5 days. They     will get the cells through a tube placed in a vein. They will get IL-2 the same way.     Participants will recover 1-3 days in the hospital. They will be monitored closely. They will     have blood and lab tests. Participants will have follow-up visits with lab tests and a     physical exam every few months for 5 years. At some visits they will also have leukapheresis,     blood tests, or vulvar biopsy....   "
256374|NCT03188406|"     Background:      Gastric cancer is a leading cause of cancer deaths around the world. It is a serious problem     in places like East Asia, Central and South America, and Eastern Europe. Researchers want to     study the causes of gastric cancer. They want to reduce the number of people with stomach     cancer.      Objectives:      To learn more about bacteria factors and other causes of gastric cancer. To study potential     markers associated with precancer gastric lesions.      Eligibility:      Adults ages 40-70 at certain hospitals in Chile who:      Are going to have endoscopies      OR have stomach cancer and need surgery      Design:      Participants will give tissue samples about the size of a grain of rice.      Some participants will donate a portion of the stomach tissue that is removed as part of     their clinical care.      Participants will give access to reports of their stomach exam. They will allow researchers     to photograph the microscope slides of their tissue samples.      Participants will answer questions. The topics of the questions include:      Age, height, weight, ethnicity      Education      Habits including tobacco and alcohol      Personal and family history of disease      Reproductive history      Diet      Some participants will give blood, urine, saliva, and stool samples. Study staff will collect     the blood. They will tell the participants how to collect the other samples themselves.   "
256521|NCT03097562|"     This study is the long term analysis of two types of FSL 3-plane corneal wound profiles,     namely CT1 and CT2 obtained after a FSL cataract surgery.   "
256369|NCT03199170|"     Cesarean section commonly induces moderate to severe pain for 48 hours. These patients have     additional compelling reasons to provide adequate pain relief as early mobilization is a key     factor to prevent the risk of thromboembolic event which is increased during pregnancy.     Beside these, patients need to be pain free to takecare for their newborn and breastfeed     them. Poorly controlled pain after cesarean section also increases risk of chronic pain and     postpartum depression.      Intrathecal morphine is considered the gold standard for postoperative pain relief after     cesarean delivery. The duration of analgesic effect of morphine extend to 12-24 hours. Its     widespread use is due to its favorable pharmacokinetic profile, ease of administration and     low cost. Although intrathecal morphine is highly effective, its use is associated with     undesirable adverse effect particularly nausea, vomiting and pruritus which reduce overall     patients' satisfaction. More serious complication is the risk of delayed maternal respiratory     depression.      The Quadratus Lumborum block was first described in 2007 which demonstrates a spread to the     paravertebral space, thus leads to a more extensive block to T5-L1 nerve branches and a long     lasting block with the potential to provide visceral pain relief. Therefore, this block has     an evolving role in postoperative analgesia for many lower abdominal surgeries. As the safety     is concerned, there has been one report of a patient with unilateral hip flexion and knee     extension weakness leading to unplanned overnight admission following lateral quadratus     lumborum block after laparoscopic gynaecological operation.      If the result favors effective, it will have the advantage of a combination with intrathecal     opioid to prolong the pain free period after cesarean section which has about 4,000 cases per     year.   "
256370|NCT03193372|"     To survey rosacea patients about their concerns, treatment satisfaction, and quality of life     associated with their Finacea Foam treatment   "
256371|NCT03190967|"     Background:      Sometimes breast cancer spreads (metastasizes) to the brain. Researchers want to study new     treatments for brain metastases. The drug Temozolomide is approved to treat brain tumors.     Researchers want to see if combining it with the drug T-DMI prevents the formation of new     metastases in the brain.      Objective:      To study if Temozolomide with T-DM1 lowers the chance of having new metastases in the brain.      Eligibility:      Adults at least 18 years old with a HER2-positive breast cancer that has spread to the brain     and was recently treated with stereotactic radiation or surgery.      Design:      Participants will be screened with        -  Medical history        -  Physical exam        -  Heart tests        -  A scan (CT) that makes a picture of the body using a small amount of radiation        -  A scan (MRI) that uses a magnetic field to make an image of the brain        -  Blood tests.        -  Pregnancy test.      The study will be done in 3-week cycles.      All participants will get T-DM1 on Day 1 of every cycle through a small plastic tube inserted     in an arm vein.      Some participants will also take Temozolomide capsules by mouth every day.      Participants will keep a medication diary.      During the study, participants will also:        -  Repeat most of the screening tests.        -  Answer questions about their general well-being and functioning.      Participants will have lumbar puncture at least 2 times. A needle is inserted into the spinal     canal low in the back and cerebrospinal fluid is collected. This will be done with local     anesthesia and with the help of images.      Participants will be asked to provide tumor samples when available.      Participants will have a follow-up visit about 1 month after stopping the study drug. They     will be contacted by telephone or email every 3 months after that.   "
256372|NCT03190941|"     Background:      A new cancer therapy involves taking white blood cells from a person, growing them in the     lab, genetically modifying them, then giving them back to the person. This therapy is called     gene transfer using anti-KRAS G12V mTCR cells.      Objective:      To see if anti-KRAS G12 V mTCR cells are safe and can shrink tumors.      Eligibility:      Adults at least 18 years old with cancer that has the KRAS G12V molecule on the surface of     tumors.      Design:      In another protocol, participants will:      Be screened      Have cells harvested and grown      Have leukapheresis      In this protocol, participants will have the procedures below.      Participants will be admitted to the hospital.      Over 5 days, participants will get 2 chemotherapy medicines as an infusion via catheter in     the upper chest.      A few days later, participants will get the anti-KRAS G12V mTCR cells via catheter.      For up to 3 days, participants will get a drug to make the cells active.      A day after getting the cells, participants will get a drug to increase their white blood     cell count. This will be a shot or injection under the skin.      Participants will recover in the hospital for 1 2 weeks. They will have lab and blood tests.      Participants will take an antibiotic for at least 6 months.      Participants will have visits every few months for 2 years, and then as determined by their     doctor.      Visits will be 1 2 days. They will include lab tests, imaging studies, and physical exam.     Some visits may include leukapheresis or blood drawn.      Participants will have blood collected over several years.   "
256373|NCT03189121|"     Background:      Increases in obesity, diabetes, and some metabolic disorders may be linked to how much     processed foods people eat. Researchers want to learn more about how processed foods affect     metabolic health.      Objective:      To learn about how a processed versus unprocessed diet affects the body.      Eligibility:      Men ages 18-50 with stable weight and risk factors for diabetes      Design:      Participants will be screened over 3 visits. Screening includes:        -  Medical history and physical exam        -  Heart and blood tests        -  Psychiatric questions        -  Questions about eating, sleeping, and economic status        -  Riding a stationary bike        -  Trying a sample meal      Between screenings, participants will eat prepared meals. They will wear an accelerometer to     measure physical activity. They will write down what foods they eat and monitor their weight.      Participants will have two 4-week stays in the clinic. They will:        -  Eat a special diet        -  Have activity and weight monitored        -  Drink water and collect urine samples to measure how many calories they are burning        -  Have resting energy expenditure measured with a clear hood over the head        -  Have a scan to measure body fat and bone density using low-dose x-rays        -  Have a scan on a table that slides into a metal cylinder in a strong magnetic field.          They will get earplugs for the loud noises.        -  Have an ultrasound test to measure blood vessels        -  Have insulin and glucose infused into an arm vein. Blood will be taken over 10 hours          through a plastic tube in the wrist. This will happen 4 times.        -  Spend multiple 24-hour periods in a room that measures oxygen used and carbon dioxide          produced.        -  Give blood, urine and stool samples        -  Answer questionnaires and do computer tasks   "
256377|NCT03186781|"     Background:      Influenza is a very common infectious disease. Influenza is also called flu. Vaccines teach     the body to prevent or fight an infection. When the body learns to fight an infection, this     is called an immune response. Researchers want to develop a vaccine against flu. They want to     test two new vaccines to help the body make an immune response to flu.      Participants will get the vaccines (shots) in the upper arm muscle. One vaccine, the     Influenza HA Ferritin vaccine, will be given to all participants with needle injection. The     other vaccine, Influenza DNA vaccine, will be given to participants in Group 3 by a     needle-free device that uses high pressure to push the vaccine through the skin and into the     muscle.      Objective:      To test the safety and side effects of two new vaccines for prevention of H2 influenza (flu).      Eligibility:      Part I: Healthy adults at least 18 years old and born after 1969.      Part II: Healthy adults ages 18-70, but not born in 1966-1969.      Design:      Volunteer participants will be tested for eligibility in a screening study.      In Part I, all participants will get shots of HA Ferritin vaccine. Five participants in Group     1 will get one shot of low dose vaccine at Day 0 to test if it is safe and has no serious     side effects. Then, five additional participants in Group 2 will get two shots of a higher     dose at Day 0 and 4 months later.      Part II will study responses of adults born before 1966 and those born after 1969. Also, Part     II will compare responses to 2 different vaccine plans. Group 3 will get a DNA Influenza     vaccine at Day 0 and the HA Ferritin vaccine 4 months later. Group 4 will get HA Ferritin     vaccine at Day 0 and 4 months later.      Participants will record their temperature and look at the injection site(s) each day for 7     days after each injection- they will write any symptoms at home on a paper diary or enter     this data online.      Participants may choose to have leukapheresis. This is a procedure where the blood will be     removed through a needle in an arm. A machine will separate some of the white blood cells     from the blood. The rest of the blood will be returned through a needle into the other arm.     The leukapheresis procedure lasts 3-4 hours.      There will be about 9 to 10 clinic visits over 10 months. At each visit, participants will be     asked about health changes or problems. They will have a short physical exam. Blood will be     taken. Participants might have extra visits and blood tests if they have changes in their     health. Vaccination visits will last approximately 4-6 hours; other visits will last     approximately 1 hour.   "
256378|NCT03270072|"     The objective of the study is to serve as a correlative study for patients enrolled on the     RadCOMP trial (NCT02603341), a randomized phase III study of stage II and III breast cancer     patients treated with either conventional photon radiation or proton beam radiation   "
256379|NCT03186794|"     Background:      As many as 1.5 million Americans are living with systemic lupus erythematosus (Lupus). Lupus     makes people very tired. It also makes it hard for people to be physically active. Studies     have shown that aerobic exercise training helps people with heart or lung illnesses be less     tired and more active. Researchers want to use an exercise training program on people with     Lupus to see if it has the same results.      Objectives:      To find out if aerobic exercise helps people with Lupus be less tired and more active.      Eligibility:      Women ages 21-80 who have Lupus and are not physically active.      Design:      Participants will be screened with a medical history and physical exam. They will have heart     and lung tests, as well as blood and urine tests. They will also answer questions about their     quality of life and take a test that measures lupus activity.      The study will last 14-16 weeks.      For the first two study visits, participants will do treadmill exercise tests and answer more     quality of life questions. For these treadmill tests, participants will wear sensors, a mask,     or a mouthpiece while they exercise.      Participants will then begin exercise training, 3 times a week for 12 weeks. At each of these     visits, they will walk very fast for 30 minutes on a track or a treadmill. Each visit will     last about 1 hour.      At the halfway point of the study, participants will repeat some of the screening tests. This     visit will last about 3 hours.      At the end of the study, participants will repeat the screening tests. They will also repeat     the treadmill exercise tests.   "
256380|NCT03190525|"     The primary objective is overall survival (OS) as predicted by baseline self-reported EORTC     QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life     Questionnaire-Core 30) fatigue scale ratings, independently from other prognostic factors for     OS in multiple myeloma (MM), including the clinically-based prognostic frailty score.   "
256381|NCT03184987|"     Despite availability of treatments and published guidelines, subjects may have asthma that is     inadequately controlled. GlaxoSmithKline is currently developing a once-daily 'closed' triple     therapy of an Inhaled Corticosteroids/Long-Acting Beta-2-Agonists/Long-Acting Muscarinic     Antagonist (ICS/LAMA/LABA) combination (Fluticasone Furoate/Umeclidinium Bromide/Vilanterol     Trifenatate [FF/UMEC/VI]) in a single device, with the aim of providing a new treatment     option for the management of asthma by improving lung function, health-related quality of     life (HRQoL) and symptom control over established combination therapies. This study has 3     study periods: Run-in, Treatment period and a Follow-up period. Eligible subjects who meet     the pre-defined criteria at screening (Visit 1) will enter into a 2-week run-in period.     Subjects will continue their pre-screening inhaled medications for asthma (ICS+LABA or     ICS+LABA+LAMA) without any change in regimen/dosage until day before Visit 2. At Visit 2     subjects will be allocated to either FF/UMEC/VI 100/62.5/25 or FF/UMEC/VI 200/62.5/25     micrograms (mcg) treatment depending on the asthma control status for 52 weeks. Switching     medication from FF/UMEC/VI 100/62.5/25 to FF/UMEC/VI 200/62.5/25 will be permitted in     accordance with the control status of the subject assessed by Asthma Control Questionnaire     (ACQ)-7 at Week 24 of the treatment period. A follow-up visit will be conducted for     approximately 1 week. Subjects will be provided with salbutamol as a rescue medication     throughout the study.   "
256382|NCT03270735|"     This is a multi-centre, randomised, double blind, placebo controlled clinical study which is     designed to evaluate the efficacy and safety of hemocoagulase in the treatment of moderate to     severe hemoptysis.   "
256398|NCT03151707|"     The primary aim of this study is to investigate the effects of exogenously administered     nicotinamide riboside (NR) on brain NAD+/NADH ratio and bioenergetics functions in healthy     individuals using phosphorus magnetic resonance spectroscopy (31P MRS) imaging.      The secondary aim is to investigate the effects of NR on brain structure and neurotransmitter     functions using other neuroimaging methods.   "
256535|NCT02754765|"     endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority,     multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened     regimens for multidrug-resistant tuberculosis (MDR-TB).   "
256497|NCT02883049|"     This randomized phase III trial studies how well combination chemotherapy works in treating     young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come     back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase     inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and     giving the drugs in different doses and in different combinations may kill more cancer cells.   "
256383|NCT03180034|"     Background:      Certain types of human papillomavirus (HPV) cause almost all cases of cervical cancer.     Vaccines that protect against HPV can substantially reduce the risk of cervical cancer.     However, HPV vaccination rates are too low, especially in countries with very high rates of     cervical cancer. HPV vaccines are expensive-many countries cannot afford them-more than one     dose is needed, and giving multiple doses is difficult. Researchers want to find out if one     dose prevents HPV infection. If it does, more people might get the vaccine.      Objective:      To find out if giving only one dose of either the Cervarix or Gardasil9 HPV vaccines work the     same as giving two doses of these vaccines to young women.      Eligibility:      Females ages 12-20 who live in Costa Rica.      Design:      Participants will be screened in a clinic with a physical exam and medical history.      Participants will have one clinic visit every 6 months for 4 years.      Participants will be randomly divided into 4 groups.      Two vaccines will be tested. Vaccines will be given in the arm at the first and second     visits. In the first visit, half the participants will randomly get the first dose of one of     the vaccines. In the second visit, six months later, participants will either get the second     dose of their initial vaccine or a control vaccine called Tdap, a booster vaccine against     tetanus, diphtheria, and whooping cough. This is so no one knows who received one dose of an     HPV vaccine and who received two.      At each visit, participants will fill out a questionnaire and give a urine sample. They may     give blood samples. The older participants will use a swab to collect cervical cells from     their vagina.   "
256384|NCT03229200|"     Multicenter, open-label, prospective treatment protocol that provides continued access to     ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from     treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying     disease within their region.   "
256385|NCT03187080|"     Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery.     Poorly managed postoperative pain can lead to increased opioid use, increased postoperative     nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital     admissions, surgical complications, and patient dissatisfaction. In light of the growing     opioid epidemic in the United States, any intervention that potentially minimizes opioid use     may have meaningful individual and societal impact. In patients undergoing breast reduction     and breast augmentation surgery, multiple techniques for managing postoperative pain are used     commonly. One such technique is the use of a paravertebral block (PVB), which is a method of     injecting local anesthesia into the area surrounding the spinal nerves in order to decrease     sensation and pain in the chests and breasts in the setting of breast surgery. PVB is     generally used concomitantly with standard multimodal perioperative pain management including     cool compress, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids. All of     these pain management strategies are used at the University of Wisconsin and are considered     standard of care for breast surgery nationwide.      The overall purpose of this study is to evaluate interventions that aim to optimize pain     control, minimize the risk of PONV, and improve recovery after elective breast surgery. We     will do this by (1) Comparing PVB with standard pain management strategies in patients     undergoing planned breast reduction and breast augmentation, and (2) Comparing enhanced     recovery after surgery (ERAS) strategies to standard of care for patients undergoing planned     breast reduction and breast augmentation. This will be studied using pain assessments,     validated surveys, medication logs, and review of medical records.   "
256386|NCT03173963|"     Background:      Diabetes is common among American Indian people and diabetic kidney disease is a common     complication. Kidney disease caused by diabetes can lead to the need for kidney replacement,     by dialysis or kidney transplant, and is also associated with higher risk of early death. A     new diabetes medicine called empagliflozin may slow kidney disease from type 2 diabetes.     Researchers want to learn if it protects the kidneys when used in very early stages of     diabetic kidney disease.      Objectives:      To see if empaglifozin delays kidney disease development.      Eligibility:      Adults 18-64 years old who are at least half American Indian and have had type 2 diabetes at     least 5 years      Design:      Participants will be screened with health questions, blood pressure, and blood and urine     tests.      Participants will have:        -  Medical history        -  Physical exam        -  Blood, urine, and stool samples taken        -  Scan of the kidneys and liver. Participants will lie on a table that slides into an MRI          machine. They will hold their breath for up to 20 seconds and the MRI machine will take          images of their kidneys and liver. They will then repeat this with a small device that          vibrates on their side.        -  Kidney tests. A needle will be placed in a vein in each arm for 4 hours. Blood pressure          will be taken. Participants will drink several quarts of water and urinate every 20          minutes. Urine and blood samples will be collected. Two liquids will be injected into          their veins to measure kidney function.        -  Photos of the back of the eyes        -  Kidney biopsy. Participants will have a scan and get drugs to make them sleepy. Up to          four very small pieces of kidney will be removed by needle. After the biopsy          participants will be monitored for at least 4 hours.        -  Nerve tests      Participants will take the study drug or placebo pill once a day. Participants will attend     for tests every twelve weeks and have more extensive kidney function tests once a year. After     3 years, participants will have another kidney biopsy and then stop taking the study drug.     They will have a final kidney function test 2 months later.   "
256387|NCT03172832|"     The optimal approach to the drainage of malignant obstruction at the biliary hilum remains     uncertain. This is a randomized comparative effectiveness study of percutaneous transhepatic     biliary drainage (PTBD) vs. endoscopic retrograde cholangiography (ERC) as the first     intervention in patients with cholestasis due to suspected malignant hilar obstruction.   "
256388|NCT03170258|"     The purpose of this study is to see if a non-medication intervention can increase motivation     and reward processing to non-drug reward cues (for example, a picture of one's favorite food)     in individuals with nicotine dependence by observing brain activity using functional magnetic     resonance imaging (fMRI). The investigators hypothesize that learning to increase brain     activity to non-drug cues may improve reward responses and motivation to non-drug cues,     eventually resulting in improved smoking cessation outcomes.   "
256399|NCT03150719|"     Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled,     parallel group, multicenter study in subjects aged 12 years and older with CF who are     homozygous for the F508del mutation on the CFTR gene and who discontinued treatment with     Orkambi due to respiratory symptoms considered related to treatment. This study is designed     to evaluate the safety and efficacy of TEZ/IVA.   "
256400|NCT03270046|"     The purpose of this study is to compare the preparation quality by using Ottawa Bowel     Preparation Scale between the standard PEG preparation and the addition of water enema in     participants scheduled for CRC screening   "
256536|NCT02755597|"     This is a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating     the efficacy and safety of venetoclax plus bortezomib and dexamethasone in subjects with     relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome     inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.   "
256389|NCT03167450|"     Background:      Sickle cell disease (SCD) is caused by a genetic defect that affects how hemoglobin is made.     Due to this, people with SCD have abnormally-shaped red blood cells, which can result in poor     oxygen transport in the body and increase risk of blood clots. CRISPR Cas9 is a new tool     which allows scientists to snip and edit genes in a way that is faster, cheaper, and more     precise than other gene-editing tools. Recently, research has been done using CRISPR Cas9 to     correct the sickle cell gene in animal models and human cells. Researchers want to understand     the views of those with SCD, parents of people with SCD, and the providers of these patients     regarding use of CRISPR Cas9 in clinical trials and treatment.      Objectives:      To study the attitudes, beliefs, and opinions of those with SCD, parents of those with SCD,     and providers on the use of CRISPR Cas9 gene-editing. An additional purpose of this study is     to assess the utility of an educational tool for improving understanding of CRISPR Cas9.      Eligibility:      People ages 18 and older who speak English and either have SCD, are a parent of someone with     SCD, or are a physician for people with SCD.      Design:      Participants will be screened via phone. Those with SCD will be screened with data from their     SCD genotype.      Participation lasts about 2 hours.      Participants will fill out three surveys.      Participants will watch a video about CRISPR Cas9.      Participants will engage in a focus group session. This will be audiotaped and analyzed.      The data from the survey questions and focus groups may be used for future research. However,     all personally identifiable information will be removed before data is shared.      Participants data will be identified with a code number instead of their name.      Participants may be invited to join future studies of SCD.   "
256390|NCT03167437|"     Background:      Crohn's disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut.     Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition. CD has     no cure, but symptoms can sometimes be controlled with medicine. Researchers want to see if     it is safe to treat CD with the medicine vorinostat. It is thought that vorinostat may reduce     the inflammation process of CD. This may then help to relieve symptoms of CD.      Objectives:      To see if vorinostat is safe for people with moderate-to-severe CD.      Eligibility:      Adults 18 65 with moderate-to-severe CD that medicine is not controlling.      Design:      Phase I is screening. It may last 120 days. Participants will have:      Physical exam      Medical history      Tests of blood, urine, and stool samples      Heart test      Questionnaires      Tuberculosis skin test      They may have a colonoscopy and lymphapheresis collection. These will be explained in a     separate consent.      They will keep a diary of symptoms.      Phase II is treatment. It will take 12 13 weeks. Participants will take the study drug by     mouth twice daily for 12 weeks. They will get a weekly phone call to talk about how the drug     makes them feel. They will have blood taken regularly. Every 4 weeks, they will have a     check-up that will repeat some screening tests.      Phase III is post-treatment. It starts with a check-up that lasts up to 2 days. Participants     will repeat some screening tests. They will have a follow-up phone call 30 days after     treatment ends. They will have check-ups 6 and 9 months after starting the study drug. They     will repeat some screening tests.      The study ends after the 9-month follow-up.   "
256391|NCT03186300|"     Patient Empowerment through Predictive PERsonalised decision support (PEPPER) is an European     Union (EU) funded research project to develop a personalised clinical decision support system     for Type 1 Diabetes Mellitus (T1DM) self-management. The tool provides insulin bolus dose     advice, tailored to the needs of individuals. The system uses Case-Based Reasoning (CBR), an     artificial intelligence methodology that adapts to new situations according to past     experience. The PEPPER system also incorporates a safety module that promotes safety by     providing glucose alarms, low-glucose insulin suspension, carbohydrate recommendations and     fault detection.The principal research objectives are to assess the usability, safety, and     technical proof of concept and feasibility of the PEPPER in participants with T1DM.     Evaluation of safety is a priority and will be assessed throughout the clinical studies. The     safety components only of the PEPPER system will initially be evaluated in an out-of-clinic     environment (phase 1) and will measure incidence and percentage time spent in hypoglycaemia,     evaluate usability and incidence of technical faults. Following the initial safety study, the     overall PEPPER system (integrated with the CBR algorithm) will be assessed (phase 2) and the     primary outcome will be percentage time spent in hypoglycaemia.   "
256392|NCT03185884|"     This study will evaluate the impact of test carbohydrate blends on fat and carbohydrate     oxidation, glucose, insulin and hunger scores in pre-adolescent boys and girls.   "
256393|NCT03157817|"     Investigation into the associations between sedentary behaviour, physical activity, body     composition and cardiometabolic risk in COPD. A single assessment visit with fasting blood     tests, body composition and strength measures followed by a week of activity monitor wear to     record sitting time and physical activity. Cardiometabolic risk markers include fasting     glucose, HBA1c, HOMA and lipids and blood pressure.   "
256394|NCT03271008|"     Comparison of various videolaryngoscope devices (Vividtrac™ and KingVision™) and direct     laryngoscopy with Macintosh blade regarding laryngoscopy time, intubation time, intubation     success rate, percentage of visible glottic opening (POGO score) in elective and acute     clinical anaesthesiology practice.   "
256395|NCT03151811|"     This is a randomized, controlled, open-label, Phase 3 multicenter study which will enroll     patients with RRMM following 2-4 lines of prior therapy and who are refractory to     lenalidomide in the last line of therapy as demonstrated by disease progression on or within     60 days of completion of the last dose of lenalidomide. Patients will receive either     melflufen+dex or pomalidomide+dex.   "
256396|NCT03149016|"     We aim to assess the treatment outcomes following upper incisors retraction accelerated by     corticotomy procedure. So, we intend to randomize orthodontic patients with class II division     I malocclusion into two groups: experimental group and control group. Both groups will start     orthodontic treatment. Once a 0.019*0.025-inch stainless steel wire is fully engaged to the     brackets, 1st premolars will be extracted. Canines will be retracted in the conventional     manner. Then, the actual evaluation period starts when the upper incisors are retracted using     two different methods.   "
256397|NCT03196765|"     This is a phase I/II, open label dose escalation study of multiple dose levels of NV1205 with     a long-term treatment phase.   "
256525|NCT02790125|"     The primary purpose of this study is to determine if single doses of BMS-986166 are safe and     well tolerated in healthy male subjects and female subjects of non-childbearing potential.   "
256401|NCT03144518|"     This study is a 2-arm, parallel, randomised controlled feasibility trial of a brief video     intervention designed to induce positive affect (mood) in older adults in primary care     settings prior to the receipt of influenza vaccination. Participants will be randomised into     two conditions: experimental and active control. In the experimental condition, participants     will view the approximately 15 minute long intervention video immediately prior to     vaccination. In the active control condition, participants will view a matched video that is     designed to be mood neutral. Pre-and-post positive affect levels will be assessed by     self-report questionnaires. Immune response to the intervention and vaccination responses     will be assessed in saliva and serum samples respectively.      The objectives of the study are to assess the impact of the intervention on mood, immune     function, and antibody response to influenza vaccination in older adults. This feasibility     trial will also allow data collection on exploring recruitment, attrition, intervention     engagement, and practicality of collecting clinical data available through electronic records     to inform the design of a future definitive trial.   "
256402|NCT03136042|"     This study evaluated whether physiotherapy is efficient in sputum induction and in evaluation     of pulmonary inflammation in asthmatic children.   "
256403|NCT03142451|"     The Primary Objectives of FX2016-11 and FX2016-12 are to determine the efficacy and safety of     FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of     rosacea.   "
256404|NCT03145272|"     This study is designed as an experimental trial which collect prospective data at Mahidol     university. It aims to characterize the responses of Thai pediatric population,age 1 - 6     years, to oxycodone oral syrup and its metabolites (oxymorphone, noroxymorphone and     noroxycodone) with specific respect to the pharmacogenomics (How drug affects patients).      A total of 20 generally healthy, opioid-naive children, aged 1-6 years, scheduled as     in-patient surgery for non-emergency surgery, non-gastrointestinal tract surgery are     involved.      The patients are divide into 2 groups (1) 10 patients in 12 months - 1.9 years, and (2) 10     patients in the 2 - 5.9 years age group.      Every patient will receive inhalational or intravenous induction of anesthesia as decided by     the anesthesia team on the day of surgery, as is routine clinical care. An intravenous     cannula (IV) will be inserted in every patient as part of their routine clinical care. No     additional intravenous line will be required for this study.      As part of the study protocol, a blood sample (5 mL) will be taken from the IV and sent for     genetic analysis. (However, in order to limit the amount of blood drawn from small babies, 3     ml will be drawn, not 5 ml, if the patient is less than 6 months or less than 10kg.) The     genetic testing is specifically to analyze the following genotypes only: CYP2D6 and CYP3A4,     which represent the differences in cytochrome P450 metabolism of oxycodone.      An orogastric tube will be placed in the stomach under anesthesia as is part of standard     routine clinical care to remove gastric contents. The same orogastric tube will be used for     intragastric liquid oxycodone administration in a dose of 0.1 mg/kg before the surgical     incision. This weight-adjusted dose of 0.1 mg/kg is administered as per standard clinical     dosing guidelines. 10 blood samples (51mL/sample) will be taken from the IV and sent for     drug-level analysis. A total of 11 blood samples will be drawn for the study. The first     sample will be sent for genetic testing. The other 10 samples will be drawn at the following     time points: 30 minutes, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose in every patient and the     other 2 samples anytime between 6 and 24 hours post-dose .      Oxycodone, oxymorphone, noroxymorphone and noroxycodone levels, at 10 time points, will be     used to determine the individual responses to oxycodone. CYP2D6 genotype will be determined     to identify the ultra-rapid metabolizers.   "
256405|NCT03126019|"     The purpose of this study is to assess the objective response rate with INCB050465 treatment     compared to idelalisib treatment in subjects with relapsed or refractory follicular lymphoma.   "
256406|NCT03126097|"     The primary purpose of this study is to evaluate the effect of single and multiple doses of     JNJ-64155806 on the steady-state pharmacokinetics (PK) of ethinylestradiol and drospirenone     and vice versa in healthy female participants.   "
256407|NCT03124459|"     This is a multicenter, phase 2 study to evaluate the safety, tolerability, pharmacodynamics     (PD), efficacy, and pharmacokinetics (PK) of ACE-083 in patients with CMT1 and CMTX, to be     conducted in two parts. Part 1 is non-randomized, open-label, dose-escalation and Part 2 is     randomized, double-blind, and placebo-controlled.   "
256408|NCT03111745|"     Background:      Some blood and immune disorders can be helped with HSCT. This is allogeneic hematopoietic     stem cell transplantation. The person who gets the stem cells has their immune system     suppressed. This is done to help prevent their body from rejecting the transplant. During     this time, the person is at a high risk to get viral infections. Researchers want to study     the records of people who had transplants a few years ago. They want to look at how often     certain viral complications happened.      Objective:      To study how often certain viral complications occurred after HSCT and what risks factors     were involved.      Eligibility:      Records will be reviewed. No participants will be contacted.      Design:      Researchers will review medical records from the NIH Clinical Center.      The records will be from people who had HSCT between 2010 and 2015 when they were between 4     and 85 years old. They already gave consent for their data to be studied.      Data collected will include:      Vital statistics like age and sex      Viral status of the recipient and donor      Reason for transplant      Transplant details      How the immune system recovered after transplant      If the recipient got graft versus host disease      Any infections      Overall survival   "
256409|NCT03114475|"     This study aims to evaluate the clinical effect of CO2 laser on enamel resistance to white     spot lesions formation around orthodontic brackets.      25 patients needing fixed orthodontic treatment will participate in the study, the CO2 laser     will be applied in a split mouth design around orthodontic brackets in two contrast quarters     of mouth in every patient and the other quarters will serve as a control. The white spot     lesion formation will be monitored around the brackets during the orthodontic treatment after     four and twelve weeks of irradiation with laser.   "
256425|NCT03092492|"     Objective:      To learn more about AMD.      Eligibility:      People ages 55 and older with any of the following:      AMD or changes in the retina that put them at risk for AMD      RPD      Healthy eyes      Design:      Participants will be screened with:      Eye exam: The pupil will be dilated with eye drops. Eye pressure and movements will be     checked. Pictures will be taken of the inside of the eye.      Reading an eye chart.      Optical coherence tomography (OCT): The eyes are dilated. A machine measures the thickness of     the retina.      Participants will have a first visit that includes:      Repeat of screening procedures      Medical history      Physical exam      Questions about vision and general health      Dark adapted fundus perimetry: Participants sit in the dark for 40 minutes. Then they sit at     a machine that shines lights in the eyes.      Dark adaption testing: Participants sit in the dark for 45 minutes. The pupils are dilated.     They push a button when they see light in a machine for up to 1 hour.      Participants will have annual visits for up to 5 years to repeat the tests in the first     visit. Participant data may be shared for other research.   "
256526|NCT02790632|"     This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid     hemorrhage.   "
256410|NCT03115359|"     Chronic low back pain (CLBP) has no known effective treatment. While often treated with     long-term opioid therapy, opioids do not work well for many patients and can cause serious     side effects, including addiction, poorer mental health, and overdose death. Even when paired     with a standard-of-care cognitive behavioral therapy (CBT), results are limited. Patients,     families and clinicians are very interested in using alternative treatments for CLBP,     especially complementary and integrative treatments such as mindfulness meditation (MM). MM     helps train the mind to bring non-judgmental and accepting attention to present-moment     experiences such as pain. MM offers an active and safe self-care approach to chronic pain     that contrasts with the passive and potentially harmful nature of opioid treatment, and may     prove more effective than CBT in helping improve health and well-being, and reduce reliance     on opioids in adults with opioid-treated CLBP. Although this hypothesis is supported by early     research, including a pilot study by the Principal Investigator, evidence on MM's     effectiveness in this population is inconclusive, presenting a critical knowledge gap.      With input from patients, family members, and clinicians, the Investigators have designed a     study to address this gap and propose a clinical trial that will compare the effectiveness of     MM to standard-of-care CBT in opioid-treated CLBP. Based on the existing research, it is     hypothesized that MM training will lead to a larger reduction in pain intensity, increase in     physical function, improvement in quality of life, and decrease in daily opioid dose, as     compared to CBT training, with benefits of MM especially notable in adults with worse mood,     anxiety or unhealthy opioid-use behaviors who often experience more severe symptoms of CLBP     and less improvement in response to existing therapies.      To test these hypotheses, 766 adults with opioid-treated CLBP from Madison, WI, Boston, MA,     and Salt Lake City, will be randomly assigned into one of two 8-week treatment groups: MM     (383 participants) that will receive the MM training or CBT (383 participants) that will     receive the CBT training. The effectiveness of MM versus CBT will be assessed over a 12-month     period with patient-reported measures, recommended by experts and endorsed by our stakeholder     partners, including patients with opioid-treated CLBP, their families and clinicians.   "
256411|NCT03109301|"     Background:      Gastrointestinal stromal tumors (GIST) can cause serious medical problems. The only known     treatment is surgery. But completely removing a GIST tumor with surgery is often not     possible. Researchers want to see if a new drug, selumetinib, can help treat these tumors.      Objective:      To find out if selumetinib shrinks or slows the growth of GIST tumors and to see its side     effects.      Eligibility:      People ages 3 and over who have one or more GIST tumors and may have neurofibromatosis type I     (also called NF1). Their NF1 GIST has shown some growth or cannot be completely removed with     surgery.      Design:      Participants will be screened with heart and eye tests and scans.      Participants will be told what foods and medicines they cannot take during the study.     Participants will keep a diary of the medicine they take during the study.      Participants will take selumetinib capsules twice daily on an empty stomach for 28 days in a     row. This is 1 cycle.      During the cycles, participants will have study visits. These may include:      Medical history      Physical exam      Blood and urine tests      Heart tests      Scans of their tumors      Eye exam      Positron emission tomography scan. They will be get radioactive glucose an IV line. They will     lie quietly in a darkened room for 50-60 minutes then have the scan.      Participants will answer questions about how they are feeling.      Participants can stay in the study until they have bad side effects or their tumor grows.      After finishing treatment, participants will be watched for side effects for 30 days.   "
256412|NCT03128346|"     The TTP block is a novel regional anesthetic technique that shows promise in providing     analgesia for anterior chest wall incisions and median sternotomy. The investigators hope to     show that by providing the TTP block, there will be reduced early postoperative pain, reduced     sedation and shallow breathing, reduced time on breathing machine, leading to an increase in     patient comfort and satisfaction. The investigators also hope the decreased need for pain     medication and reduced time on the breathing machine will translate into decreased nursing     workload.   "
256413|NCT03117595|"     Analgesia in labour is not readily available in many parts of Sub-Saharan Africa. The overall     cost of Epidural services in terms of human personnel and financial implication makes this     inaccessible to many women in labour. Thus, a cheaper, less technically demanding and easier     option that can produce as much satisfaction for the parturient and would allow her     participate in the second stage of labour by being able to bare down is being studied.      The Single Shot Spinal (SSS) would provide pain relief in these women however its draw back     is its time limitation as the option of a top up is not available.      Two regimen of drug options would be considered using opioids. These would be compared to see     how well they are able to provide analgesia in women who hitherto have had vaginal birth.     Their onset, duration of action and possible side effects would be compared.      NULL HYPOTHESIS: Single Shot Spinal with Bupivacaine Fentanyl (BF) cannot provide a     statistically significant difference in labour analgesia in comparison with Bupivacaine     Fentanyl Morphine (BFM) ALTERNATE HYPOTHESIS: Single Shot Spinal with BF can provide a     statistically significant difference in labour in comparison with BFM   "
256414|NCT03105492|"     Background:      Prenatal whole genome sequencing (PWGS) will give expecting parents large amounts of genetic     data about their baby. This raises ethical concerns. Researchers want to find out if women     want access to the kind of data PWGS provides. They want to know why and under what     circumstances women would or would not want the data.      Objective:      To explore the views of pregnant women about possible use of PWGS. To find out whether they     would want different categories of genetic data, and how they would use such findings.      Eligibility:      Women ages 18 and older who are between 8 and 30 weeks of pregnancy and speak English or     Spanish      Design:      Participants will be recruited by their doctors.      Participants will take a survey about their views of PWGQ. They may take it online or on     paper.   "
256415|NCT03104725|"     Background:      Parkinson s disease (PD) causes slow movement, stiffness, and poor balance. Many symptoms are     due to the loss of brain cells that make the brain chemical dopamine. The cells may be     damaged by the breakdown of dopamine by a process called oxidation. The drug N-acetylcysteine     (NAC) can act as an antioxidant. Researchers want to test if NAC can decrease the oxidation     of brain dopamine in people with PD.      Objective:      To look at the effect of NAC on brain chemistry in people with PD.      Eligibility:      People ages 18 and older with PD that was diagnosed within the past 5 years. They must be     taking a monoamine oxidase inhibitor.      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Participants will be hospitalized for 4 to 8 days.      On day 1, they will have blood and urine tests. They cannot eat or drink anything but water     and their medications for several hours. Late in the morning they will have a meal.      About 2 hours later they will have a spinal tap. For this, a numbing medicine is injected     into the back. A needle is inserted between the bones in the back to remove a small amount of     fluid. The spinal tap may be use x-rays to see inside the body.      After the spinal tap, they will start taking NAC by mouth.      They will take NAC twice a day for 2 more days.      On the next day, they will not eat until a meal in the late morning. They will take a final     NAC dose.      About 2 hours later they will have a second spinal tap.   "
256416|NCT03270839|"     Sea sickness represents a major limitation on the performance of ships' crew. One of the     challenges faced by the physician in the motion sickness clinic when prescribing anti-sea     sickness medication is to select the appropriate drug for the patient. Difficulties arise due     to high variability in the response to different drugs. In the case of sea sickness, the     current procedure is to examine the drug's efficacy in each individual during real time     exposure to sea conditions.      A number of studies have documented the presence of sea sickness drug receptors in the     vestibular nuclei, which determine the vestibular time constant. Two clinical vestibular     tests which evaluate the time constant are the Velocity Step and OKAN tests. The purpose of     the proposed study is to evaluate the influence of motion sickness drugs on the vestibular     time constant, as a possible bioequivalent of drug potency in the individual subject. Eighty     crew members will be recruited and divided into groups responsive and non-responsive to the     sea sickness drugs scopolamine and meclizine.      Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and no     improvement in symptoms after treatment will be defined as non-responsive to sea sickness     drugs. Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and a     Wiker score of 4 or less after treatment, will be defined as responsive to drug therapy.      Kwells, Bonine and placebo, will be assigned to each subject in a random, double-blind     fashion. Each group will perform the Velocity Step and OKAN tests before, one and two hours     after drug or placebo administration.   "
256417|NCT03098862|"     Background:      Genes are instructions that tell the body how to work and grow. They can affect how the body     responds to infection. Researchers want to learn more about genes that affect how the body     responds to the Ebola virus. Some people with Ebola get very sick and die. Others do not. The     research may lead to better treatments for Ebola virus and other germs.      Objective:      To look for genes that may be related to a person s chance of getting very sick after coming     in contact with the Ebola virus.      Eligibility:      People at least 3 years of age who either:      Had Ebola      Had close contact with someone who had Ebola      Were in an Ebola vaccine study      Design:      Participants will have a small amount of blood taken from an arm vein by a needle.      Researchers will collect participants data from other vaccine studies they may have been in.      Participants may be asked questions about their health and social history.      Some participants will have their blood tested for the infection syphilis and HIV, the virus     that causes AIDS. Participants will be told the results and will get help finding care, if     necessary.      Some participants will have their blood sample tested to see if they have had Ebola in the     past.      Blood samples will be stored for future research. They will be marked with a code but not     with participants names.   "
256418|NCT03103919|"     Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical     practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence     to Neupro compared with only standard clinical practice.   "
256419|NCT03106376|"     This study evaluates the impact of hypoxic and hyperoxic breathing on measures of brain redox     balance and metabolism in healthy individuals. All participants will undergo an MRI scan     during administration of air mixtures with different oxygen concentrations to collect the     brain measures.   "
256420|NCT03099304|"     The purpose of this study is to examine the efficacy, safety, and tolerability of INCB018424     cream in subjects with vitiligo.   "
256421|NCT03110224|"     Post Market clinical outcomes study to collect data on the short - and long-term outcomes for     subjects who are undergoing or who have undergone the Subchondroplasty (SCP) Procedure in the     knee in a standard clinical setting. Outcomes to be assessed include pain medication usage,     pain, function, activity levels and patient satisfaction.   "
256422|NCT03112200|"     This is a multi-center, prospective, single-blinded, two-arm study, randomized to include 134     subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy     alone.      The primary objective of this study is to demonstrate superiority of Subchondroplasty with     arthroscopy compared to arthroscopy alone for treatment of Bone Marrow Lesions (BMLs) in the     knee.   "
256423|NCT03104348|"     A recent French study conducted in the general population in the north, using more than     12,000 people randomly drawn from the electoral lists, shows a prevalence of nearly 15% of an     obstructive spirometric function disorder; The diagnosis was ignored in 70% of cases. If we     consider the Finistère situation, the mortality data are unfavorable, with an excess of COPD     mortality compared to the French average.      Compared to other frequent chronic conditions, such as high blood pressure or diabetes, the     management of COPD may appear complex for at least two reasons:        -  Screening is difficult because of the banality of symptoms and the need for spirometry          to confirm the diagnosis;        -  Comorbidities are masking the respiratory pathology; It is on this first point          concerning the difficulty of screening that this project focuses.      It is true that the development of screening strategies for COPD has been the subject of     numerous studies, the results of which are controversial. The target population of smokers     over the age of 40, who are readily selected, is difficult to achieve as a whole because the     use of care is far from homogeneous. Many people do not have a general practitioner.      Recent reviews of COPD screening do not recommend systematic screening for COPD in adults.     However, they emphasize the feasibility of screening by questionnaire and / or portable     spirometry. A selection of patients suspected of exacerbations (patients with at least one     episode labeled bronchitis) could increase the cost-effectiveness of screening by focusing     on the most severe cases.      In France, the High Authority for Health (HAS), inspired by the work of the WHO (GOLD     programs), offers a simple five-question questionnaire available online for all healthcare     professionals in order to facilitate an indication of screening spirometry, where the     proposed approach combines symptom identification with active smoking. General practitioners     are in this first line of approach for the diagnosis: in fact, the HAS, in its guide of the     pathway of care of the patient COPD, recommends that the general practitioner can carry out     the spirometric screening. The corresponding pulmonologist intervenes in this course by     completing the explorations and optimizing the management, especially in patients with     frequent exacerbations. This ideal scheme is hampered by the present practical organization,     a minority of general practitioners (10%) practicing in multidisciplinary health centers,     places where the organization of a functional respiratory measurement can be easier.      The current recommendations for smoking cessation allow the coding of this management. It is     global, applicable in primary care. It proposes as a starting point the minimal advice, then     associates medicines of assistance with the stop, cognitive-behavioral therapies and a     prolonged follow-up of the patients after weaning. However, although these comprehensive     management techniques are effective for smoking cessation, it is shown that they are     underutilized in routine practice by health professionals with low patient participation     rates. This is noticed, whereas the application of the minimum board alone would allow about     200 000 people to have access to weaning every year.      In a complementary way, the performance of a functional respiratory test in the active     smoking patient has been proposed as a full-fledged tool for the weaning assistance process.     Analysis of the literature, however, yields discordant results. Two recent studies have     revived the debate: they highlight the potential of spirometry as a communication medium in     the context of smoking cessation (using pulmonary age) by confronting patients with the     discovery and understanding of their ventilatory disorder obstructive.      Finally, if other health care providers are invited to participate actively in screening,     including pharmacists, their place in this screening strategy has been less valued. In     particular, pharmacists and dentists are required to provide care to patients with little or     no use of the general practitioner: screening for COPD among these patients deserves     consideration. Similarly, nurses occupy a special place, being called in particular to carry     out regular care of patients, both in their office and at home. The administration of     injectable antibiotics in a context of exacerbation of unlikely COPD is a frequent care     opportunity, which may include this more comprehensive approach. Finally, physiotherapists,     who are increasingly trained in the concept of respiratory rehabilitation, are taking charge     of other potentially COPD smokers for other pathologies.      Based on the willingness of Finnish actors to work on a COPD pathway with the help of the     regional health agency, the investigators propose to question the respective place of health     care professionals involved in primary care among potentially COPD patients: Dentists,     nurses, general practitioners, physiotherapists and pharmacists   "
256424|NCT03092687|"     Background:      The Human Brain Collection Core (HBCC) collects brain and other tissues. They get these from     deceased people who may or may not have had psychiatric disorders. The next of kin gives     permission for researchers to get the tissues. Researchers want to collect medical details of     people whose brains are donated. They also want to use the donated tissue to study brain     chemistry and structure. This could lead to better treatments for mental illness.      Objective:      To create a collection of human brain tissue to learn about the causes and mechanisms of     mental disorders.      Eligibility:      People willing to donate their deceased relative s brain tissue. The deceased person could     not have had any of the following:      Severe mental retardation      Long-lasting seizure disorder      Infections that affect the brain      Decomposition      Brain damage      Being on a respirator for more than 12 hours      Major sepsis      Serious renal or hepatic disease      Certain dementias and degenerative diseases      Design:      Medical Examiner s Offices will screen donors who have recently died. Some others will be     screened by hospitals or funeral homes.      Participants will be the next of kin. They will give consent for HBCC to obtain brain tissue     from the deceased person. The tissue will be frozen for future research.      Participants will have a 30-minute phone call. They will answer questions about the deceased     person s medical and psychiatric conditions. They will answer questions about the person s     use of medicines and drugs.      Participants will be contacted by a social worker. They will be asked for permission to     access the deceased person s medical records.   "
256470|NCT02965599|"     GSK3117391 has the potential to complement existing therapies in the treatment of chronic     inflammatory disorders such as rheumatoid arthritis (RA). This study will evaluate the     efficacy, safety and tolerability of oral GSK3117391 (Dose A) administered to subjects with     severe RA despite treatment with disease-modifying anti-rheumatic drugs (DMARDs). This is a     randomised, double-blind (sponsor open), multicentre, placebo-controlled, parallel group     study. The total maximum study duration is approximately 10 weeks. Following a screening     period of up to 28 days, subjects will be randomized (1:1) to placebo or GSK3117391 (Dose A)     administered orally for a period of 28 days. Subjects will be followed up for 7 to 14 days     post final dose. Approximately 40 subjects with severe RA will be randomised into the study.   "
256426|NCT03092505|"     Background:      Herpes virus can cause sores on the body. It can cause flu-like symptoms like fever and     muscle aches, and even a type of cancer. Many people with HIV also have infections with     herpes virus. When these people start taking HIV medicines, their herpes virus symptoms can     suddenly start or become worse. Researchers want to find out more about how often this     happens and why.      Objective:      To study the effects of HIV treatment in women who may have herpes virus infections.      Eligibility:      Women age 18 years and older who have been diagnosed with HIV infection.      Design:      Participants will be screened with a physical exam, medical history, and blood and urine     tests.      Participants will have about 8 study visits. Each will take about 1-2 hours.      Participants will return to the clinic 1-2 weeks after the screening visit to receive their     antiretroviral (ART) medicine. They will get instructions for taking it.      Participants will have 6 more study visits over 1 year.      During study visits, participants will have blood and urine tests, vaginal fluid collected,     and an oral swab. They may have an external genital exam. They will get their next supply of     ART medicine.      Some participants may have a chest x-ray.      Participants may have leukapheresis. Blood will be removed through a needle in an arm. It     will be run through a machine that separates out the white blood cells. The rest of the blood     will be returned through a needle in the other arm.      The total time participants will be in the study is about 1 year.   "
256427|NCT03101982|"     Hypothesis of the Study:      Based on the presented results, the investigator hypothesises that HBO preserves neurons that     are not irreversibly damaged (i.e. severed) during initial trauma, thus enabling regain of     their function. The investigator predicts that HBO treatment protects and enhances motor     function in initially paralysed regions, including improvement in function of the extremities     as well as recovery of urinary bladder control and bowel function.      Outline of the Proposed Study:      Within a prospective proof of principle trial, a total of 100 patients will be included.     Fifty patients will be recruited at the Division of Thoracic and Hyperbaric Surgery, Medical     University of Graz. In parallel, 50 control patients will be included at the Department of     Orthopaedics and Trauma, Paracelsus University Salzburg, Salzburger Landeskliniken (SALK),     Austria. Thereby, all patients that are admitted at the Medical University of Graz can be     treated and the enrolment of 50 patients into the treatment group can be implemented within     the outlined time frame. The active recruitment period is planned for three years. Both HBO     treated and control patients will undergo the same surgical and nonsurgical procedures. HBO     treatment will be started within 24 hours after the injury. A total of 21 consecutive daily     sessions will be applied, followed by routine rehabilitation programmes. By matching control     and HBO-treated patients, an evaluation of the treatment effect of HBO is possible. The     outcome will be evaluated by implementing the American Spinal Injury Association     (ASIA)-scores and magnet resonance (MR) imaging. Additionally, inflammatory and regenerative     blood markers will be analysed (neuroendocrine markers/neuro-transmitters: S100beta, Brain     Derived Neurotrophic Growth Factor [BDNF], Glial Fibrillary Acidic Protein [GFAP], Reactive     Oxygen Species (ROS), norepinephrine; array of pro- and anti-inflammatory cytokines and     chemokines).   "
256428|NCT03085797|"     Nasal polyps (NP) has long been known as chronic inflammatory disease of the nasal mucosa.     This disease is characterized by the presence of polyps in the upper nasal cavity,     originating from within the ostiomeatal complex. The presence of polyps can cause long-term     symptoms such as prominent nasal obstruction, post-nasal drip, loss of smell, and discharge.      Mepolizumab (SB240563) is an Immunoglobulin G 1 [IgG1], kappa humanized monoclonal antibody     (mAB) that blocks human interleukin-5 (hIL-5) from binding to the interleukin-5 (IL-5)     receptor complex expressed on the eosinophil cell surface and thus inhibits signaling.     Neutralization of IL-5 with mepolizumab has been shown to reduce blood, sputum and tissue     eosinophils and hence is assumed to be a treatment option in a number of eosinophilic     diseases including NP.      The aim of this randomized, double-blind, parallel group, phase 3 (PhIII) study is to assess     the clinical efficacy and safety of 100 milligram (mg) subcutaneous (SC) mepolizumab as an     add on to maintenance treatment in adults with severe bilateral NP. The study will include a     4-week run in period followed by randomization to a 52-week treatment period. Participants     will receive mepolizumab 100 mg or placebo SC by the investigator or delegate via a     pre-filled safety syringe every 4 weeks for 52 weeks. Throughout the entire study period (run     in + treatment period + follow up), participants will receive a standard of care (SoC) for NP     which consists of daily mometasone furorate (MF) nasal spray, and if required, saline nasal     douching, occasional short courses of high dose oral corticosteroids (OCS) and/or     antibiotics. The treatment period will consist of thirteen, 4-weekly doses of mepolizumab or     placebo. In addition, up to the first 200 randomized participants will be followed up every     other month for up to a further 6 months after the Visit 15 (7 months post last dose) in     order to assess maintenance of response and to validate a physiological model derived from     the previous Phase 2 study. Approximately 400 participants will be randomized (200     participants per treatment arm) in to the study. Total duration of the study will be 76 weeks     for first 200 randomized participants and 52 weeks for remainder of participants who are not     participating in the 6 months no treatment follow up.   "
256429|NCT03103490|"     The investigators will evaluate the detection of cardiac sarcoidosis or inflammation using     18F-FSPG PET/MRI.   "
256430|NCT03076567|"     Background:      Stomach cancer is common around the world. The US is a low-risk region. But the 5-year     survival rate in the US is low. This is because the cancer is usually in a late stage by the     time it is diagnosed. One way to detect it earlier is to screen many people with a procedure     called endoscopy. But this may not be feasible in low-risk or developing countries.     Researchers want to find a biomarker for early-stage disease to help them create an effective     way of screening. DNA methylation is a chemical modification of DNA. It generates a signal     for certain cancers, including stomach cancer. Researchers want to find a blood-based DNA     methylation marker for stomach cancer.      Objective:      To study plasma DNA methylation as a potential biomarker for detection of stomach cancer.      Eligibility:      Participants from 2 studies already done in China      Design:      Researchers will use blood samples from participants in the 2 studies. The blood was     collected in 1999/2000. They will use samples from some who developed stomach cancer between     those years and 2006. The other samples will be from some who stayed cancer free in that     time.      Participants already gave written informed consent.      Researchers will take DNA from the samples. They will look for methylation.   "
256431|NCT03127722|"     This study is designed to assess post-procedural outcomes for women who chose to undergo     either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including:        -  Pelvic and/or lower abdominal pain        -  Abnormal uterine bleeding        -  Surgical intervention (including insert removal and hysterectomy)        -  Allergic, hypersensitivity, or autoimmune-like reactions   "
256432|NCT03077555|"     Quick starting combined oral contraception containing estradiol hemihydrate/nomegestrol     acetate is effective to inhibit ovulation in healthy reproductive age women and     non-inferiority to combined oral contraception containing ethinyl estradiol/gestodene.   "
256537|NCT02747043|"     This trial is designed to determine what effects the human body has on the      investigational medicine, ABP 798, and what effects the body has on the investigational     medicine after you have been given it, and if this is comparable to what is seen for the     licensed medicine, rituximab, in patients with CD 20 positive B-cell non Hodgkin lymphoma.      This study will assess if the investigational medicine is safe and effective in treating CD     20 positive B-cell non Hodgkin lymphoma.   "
256433|NCT03068546|"     Background:      The human biome is the collection of microbial genes found in and on the body. It has been     associated with many health conditions. But certain factors might affect the findings from     microbiome studies. These include collection method, lab handling, and data processing.     Researchers want to test the effect of long-term storage in a freezer on two oral sample     collections methods. These methods are OMNIgene ORAL and Scope mouthwash.      Objective:      To test the effect of long-term freezing on the oral microbiome measured from OMNIgene ORAL     and Scope mouthwash.      Eligibility:      Employees of the National Cancer Institute who:        -  Are age 18 or older        -  Have not used antibiotics in the past 3 months      Design:      Participants will have 6 visits within 2 weeks. At visit 1 they will complete a questionnaire     about health and lifestyle. All visits last 15-30 minutes and include:        -  1-2 saliva samples using OMNIgene ORAL: They will spit in a collector.        -  1-2 Scope samples: They will gargle with Scope mouthwash and spit in a cup.        -  Questions about how well they followed the preparation procedures      Participants will follow preparation procedures: For 12 hours before each visit, they must     not:        -  Brush their teeth        -  Floss        -  Use mouthwash        -  Eat or drink anything other than water        -  Chew gum        -  Consume throat lozenges or candies        -  Smoke or chew tobacco      Participants samples will be stored in a freezer. They will get data about their oral     microbiome if they wish.   "
256434|NCT03067389|"     A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide     a sample for genetic testing and information about their medical and family history. The     results of the genetic test will be combined with clinical data to validate a method of     predicting breast cancer risk.   "
256435|NCT03062839|"     This study aims to evaluate the effect of melatonin supplementation as adjuvant treatment in     ADHD in adults.   "
256436|NCT03061097|"     This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent     Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety,     feasibility and the role of autologous fecal microbiota transplantation (FMT) for the     prevention of antibiotic resistant bacteria (ARB) through microbiome restoration.   "
256437|NCT03058640|"     This randomized control study will investigate the health outcomes of adolescents with Down     Syndrome who participate in a karate class as measured by ALPHA fitness testing and various     PROMIS parent proxy questionnaires to assess participants mobility, physical activity, and     overall affect.   "
256438|NCT03056755|"     Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+,     HER2-negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6     treatment with an aromatase inhibitor (AI) or fulvestrant   "
256439|NCT03055013|"     This randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a     kidney) with or without nivolumab in treating patients with kidney cancer that is limited to     a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may     interfere with the ability of tumor cells to grow and spread. Giving nivolumab before     nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to     be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab     and nephrectomy is more effective than nephrectomy alone in treating patients with kidney     cancer.   "
256440|NCT03070392|"     To evaluate the overall survival of HLA-A*0201 positive adult patients with previously     untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine,     ipilimumab, or pembrolizumab.   "
256441|NCT03052751|"     The purpose of the study is to evaluate the clinical efficacy of UCB7665 as an     chronic-intermittent treatment in subjects with generalized myasthenia gravis (MG) who are     classified as moderate to severe.   "
256442|NCT03049735|"     The purpose of this study is to determine the benefit and safety of relugolix 40 mg once     daily co-administered with low dose estradiol and norethindrone acetate compared with placebo     for 24 weeks on heavy menstrual bleeding associated with uterine fibroids. Additionally, this     study is designed to evaluate the benefit of relugolix 40 mg once daily for 12 weeks followed     by 12 weeks of relugolix 40 mg once daily co-administered with low dose estradiol and     norethindrone acetate compared with placebo for 24 weeks in the same population.   "
256443|NCT03066570|"     Objective: To investigate the effects of a cognitive behavioural intervention targeting     specific fears in patients with painful diabetic neuropathy, on physical activity and quality     of life.   "
256444|NCT03046446|"     This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to     Patients with Osteoarthritis of the Knee   "
256445|NCT03070782|"     This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to     evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of     different doses and dosing regimens of ISIS 681257 for reduction of plasma Lp(a) levels in     patients with hyperlipoproteinemia(a) and established cardiovascular disease (CVD).   "
256446|NCT03039114|"     The purpose of this study is to evaluate the safety and efficacy of INCB050465 when combined     with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular     lymphoma (FL).   "
256447|NCT03041181|"     This is a randomized phase II study assessing the activity of docetaxel combined with     nivolumab compared to docetaxel alone in metastatic or recurrent squamous or non-squamous     non-small cell lung cancer (NSCLC) subjects who recently progressed on a PD-1 or PD-L1     inhibitor.      Upon registration, subjects will be randomized in a 1:1 ratio to either treatment with     docetaxel alone or docetaxel in combination with nivolumab. Randomization is un-blinded and     open-label; therefore there will be no placebo treatment for subjects randomized to docetaxel     monotherapy.   "
256448|NCT03039101|"     The purpose of this study is to see if the recruitment of a certain cell type (the alpha 4     integrin (CD49d) expressing neutrophil) during a nasal allergen challenge can be inhibited by     pretreatment with an FDA approved leukotriene antagonist (montelukast).   "
256538|NCT02750995|"     The purpose of this phase I study is to investigate the combination of hypomethylating agents     with experimental peptide vaccination against four selected tumor antigens, known to be     upregulated in response to hypomethylating agents, in patients with high risk myelodysplastic     syndrome and acute myeloid leukemia.   "
256539|NCT02745769|"     The main purpose of this study is to evaluate the safety of ramucirumab in combination with     other targeted agents in participants with advanced cancers.   "
256449|NCT03034915|"     COPD is characterized by an airflow limitation, which is not fully reversible, usually     progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a     major cause of disability and anxiety associated with the disease. In addition, COPD is     associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to     improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations,     and also to improve health status and exercise tolerance.      This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to     compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5     mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD.     The primary purpose of this study is to demonstrate improvements in lung function for     subjects treated with UMEC/VI compared with UMEC for 24 weeks.      Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio.     Subjects will be stratified based on long-acting bronchodilator usage during the run-in     period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either     UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA®     dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once     daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol     (50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA     DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2     weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week.      ELLIPTA and DISKUS are trademarks of GSK group of companies.   "
256450|NCT03034811|"     The primary objective of this study is to obtain implant survivorship and clinical outcomes     data for the commercially available Persona Partial Knee System.   "
256451|NCT03034967|"     Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a     potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized,     double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the     clinical activity and safety of danirixin compared with placebo in participants with COPD.     Following baseline assessments collected over a 7 day period participants will be randomized     (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram [mg], 10 mg, 25     mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally twice daily for     24 weeks. Participants will continue with their standard of care inhaled medications (i.e.     long acting bronchodilators with or without inhaled corticosteroids) while receiving study     treatment. Follow up will continue up to 28 days post last dose. Approximately 700     participants will be screened with a target of 540 participants completing 24 weeks of     treatment and key study assessments.   "
256452|NCT03037203|"     This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending     dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and     PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult     subjects with idiopathic PD.   "
256453|NCT03030833|"     The purpose of the study is to assess device performance in the presence of carbon monoxide.   "
256454|NCT03085888|"     GRAIL is using high-intensity sequencing of circulating cell-free nucleic acids (cfNAs) to     develop blood tests to detect cancer early. The purpose of this study is to train and     validate an assay to detect invasive breast cancer in patients undergoing mammography.   "
256455|NCT03025009|"     The main purpose of this study is to investigate the side effects related to LY3192767 when     given as an injection under the skin to healthy participants. Blood tests will be done to     check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to     get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and     Part B. Each participant will enroll in one part. For each participant, Part A will last up     to about 32 days after last dose and Part B will last up to about 49 days after last dose.     Screening must be completed prior to study start.   "
256456|NCT03019536|"     The study involves repeated doses of LY3303560 given by injection over 48 weeks. The study     will examine how safe repeated doses of LY3303560 are, whether they cause side effects in     participants with mild cognitive impairment or Alzheimer's Disease, and how LY3303560 is     handled by the body and acts in the body. This study will last about 64 weeks, not including     screening. Screening is required within 70 days prior to the start of the study.   "
256457|NCT03012061|"     This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25     mcg on lung function versus placebo after 24 weeks of treatment. This study will provide     important information regarding the efficacy and safety of UMEC when administered in a     separate inhaler to subjects on a background of fluticasone furoate (FF). This is a Phase     IIb, randomized, double-blind, placebo controlled study that will compare the efficacy,     safety and tolerability of UMEC (62.5 mcg and 31.25 mcg) administered once-daily in subjects     with asthma that is not well controlled. Eligible subjects will be requested to participate     in the study for a maximum of approximately 31 weeks with 4 phases (pre screening,     screening/run-in, randomization/treatment and safety follow-up). The total number of     randomized subjects required is approximately 384, with 128 subjects randomized 1:1:1 to each     of the 3 double-blind treatment arms.   "
256458|NCT03010527|"     This is a multicenter extension study to assess the long-term safety, tolerability and     efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis   "
256471|NCT02964507|"     This is a combination Phase I and Phase II study, with an aim to evaluate the combination of     GSK525762 and fulvestrant in women with advanced or metastatic ER+ breast cancer, who have     disease that has progressed after prior treatment with at least one line of endocrine     therapy.      The objectives of the study are to first identify, in open-label single-arm Phase I, a     recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I     will follow a modified toxicity probability interval (mTPI) design, and a sentinel group will     be evaluated first for dose-limiting toxicity and further expanded to collect additional     safety data. This will be followed by a double-blind, randomized controlled Phase II, to     identify the clinical activity of the two study treatments when given in combination. The     composition of Phase II will be selected at the end of Phase I.      Approximately, up to 140 subjects and 154 subjects will receive study treatment in Phase I     and Phase II respectively. A completed subject will be one who is followed until death.   "
256459|NCT03002012|"     Cryptococcal meningitis or Crypto is a life threatening fungal infection around the brain     that requires hospitalization for treatment for 14 days and then continued therapy. Crypto     causes 15-20% of HIV/AIDS-related deaths worldwide. However, this infection can be detected     before one develops symptoms and becomes ill. People can be screened for infection by a blood     test to detect cryptococcal antigen, (called CrAg), which is part of the fungus, in blood.     The World Health Organization and over 22 countries worldwide recommend CrAg screening of all     persons with advanced AIDS entering or re-entering into HIV care.      However, it is not known how best to treat people with cryptococcal antigen in their blood,     who don't otherwise yet have symptoms of infection around their brain. If no treatment is     given, almost all people will develop infection of the brain and/or die. International     guidelines suggest using both HIV medicines and an anti-fungal medicine, called fluconazole,     to treat this early infection. However, despite this treatment approximately 1 in 4 people     may get sick and/or die.      Researchers have recently discovered another medicine that may work against the Cryptococcus     fungus. This medicine is called Sertraline, and it is actually a medicine that has been used     for more than 25 years to treat depression (sadness). Sertraline is one of the most commonly     used medicines worldwide.      The purpose of this research clinical trial is to determine if standard fluconazole     antifungal therapy plus a high dose of Sertraline, will be better than standard fluconazole     therapy alone for treating early disseminated cryptococcal infection in persons who are     asymptomatic and do not yet have infection of the brain (i.e. meningitis).      This study seeks to test if Sertraline will improve survival through 6-months. Prior studies     have shown that >90% of those who survive 6-months will survive >5 years.   "
256460|NCT02991456|"     The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral     rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG)     patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a     randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the     prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT     and concomitant multi-dose TMZ.   "
256461|NCT02989389|"     The main purpose of this study is to investigate the safety of LY3323795 and the effects it     has on the body. The study drug or placebo (sugar pill) will be given by mouth to healthy     participants. The study has three parts. Each participant may only enroll in one part. The     study will last 14 to 43 days, depending on the part. Screening must be completed prior to     study start.   "
256462|NCT03062891|"     Insomnia occurs frequently causing a substantial burden to society (1). Historically,     insomnia has been considered as secondary to a handful of other psychiatric disorders, such     as depression and anxiety - but it is now clear that this disorder is associated with a wide     range of psychiatric conditions and may actually precede and predict their development and     severity (e.g. 2). Treating insomnia has been posited to hold the promise of reducing or     preventing the development of co-morbid problems - although this possibility needs to be     rigorously tested.      Cognitive behavioural therapy (CBT) is an effective treatment for disturbed sleep,     specifically insomnia, in adults (3) and is recommended by NICE for the management of     long-term sleep problems. This treatment is more accessible than ever before given recent     ground-breaking internet initiatives - such as the Sleepio programme (see:     https://www.sleepio.com/home/), which was developed by one of the collaborators (Colin Espie)     and has yielded encouraging results (4).      Despite the importance of CBT for treating disturbed sleep and the finding that it leads to a     good outcome for the majority of sufferers, some people fail to respond to this treatment.     For example, research cited on the Sleepio website notes that around 70% of those with even     very long term sleep difficulties experience long-term improvements from the treatment,     meaning that 30% do not (see 4). Understanding more about who does and does not respond holds     the promise of improving or tailoring treatments for insomnia.      The study proposed here builds on recent work by one of the researchers who has been     exploring demographic (5), clinical (e.g. 6) and most uniquely genetic (e.g. 7); and     epigenetic (e.g. 8) predictors of psychological treatment response (coining the term     Therapygenetics, see, 7). While these predictors are individually only likely to explain a     small proportion of the variance of treatment outcome, understanding these multiple risks and     their interaction is the best way to consider this issue. The study addressed here is a pilot     study, necessary to demonstrate feasibility of utilising a sleep intervention application in     an unselected sample of young adults, prior to applying for grant funding to undertake a     larger but similar behavioural genetics study in the future.      The main aim of this pilot study is to test the feasibility of the study design, by     investigating whether unselected participants show an improvement in sleep quality after     taking the intervention. Participation and drop out rates as well acceptability of the     intervention in a non-clinical population will also be investigated.      Research Questions:        1. Does the online CBT intervention improve sleep quality in a non-clinical, unselected          sample?        2. How feasible is it to run this study on a non-clinical sample? This will include          investigating response rate, participant drop-out, and treatment accessibility.           The investigators will also offer perform preliminary investigations into:        3. Does improving sleep quality have implications for associated phenotypes? Specifically          the investigators will examine symptoms of anxiety, depression, attention-deficit          hyperactivity disorder (ADHD), psychosis, and well-being.        4. Which demographic, clinical, genetic, and epigenetic factors predict treatment outcome          for sleep problems?      Research questions 3) and 4) will be primary aims in the main study, but will constitute     secondary aims in the pilot study as there won't be the statistical power to fully address     these questions.   "
256463|NCT03051451|"     Clinical trial, multicenter, double-blind, placebo-controlled, comparative of three parallel     groups, randomized treatment to assess the efficacy and safety using a fixed dose combination     of metformin hydrochloride with fluoxetine as adjunctive treatment in patient with obesity or     overweight in order to generate new knowledge and give a greater number of therapeutic     options to the clinicians, one group will receive metformin 1700 mg and 40 mg of fluoxetine;     Another group will receive metformin 1000 mg with 40 mg of fluoxetine, and a third group     called control will receive placebo.      The above described treatments will be administered according to the Dosage Schedule The     three groups will receive tablets of physical characteristics equal to the reference drug to     preserve the blinding.   "
256464|NCT02979574|"     The purpose of this study is to compare two types of acupuncture with usual care on treating     chronic pain. This study has three groups. Two groups will received acupuncture. One group     will receive usual standard of care for 12 weeks and then will receive acupuncture.     Acupuncture is an ancient Chinese technique of using very thin needles inserted in the skin     to treat different symptoms and illness, and to promote healing. Each group will undergo a     different method of needle administration.   "
256465|NCT02974322|"     The purpose of study is to test the effect of an experimental medication GED-0301(mongersen)     and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The     study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded     which means that patients and the study doctor will not know which treatment has been     assigned. Patients in this study will be allowed treatment with stable doses of oral     aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment     of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of     exclusive enteral nutrition and growth hormone.      All patients who complete the study will have the option to enter a long term active     treatment study.   "
256466|NCT02977767|"     Tracheotomy is requested when upper aero-digestive tracts are obstructed. This obstruction     can have a tumour, infectious, inflammatory, traumatic or nervous origin. Most tracheotomy     surgeries are performed for tumour-induced obstruction. Tracheotomy allows the setting of a     respiratory flux thanks to a cannula and excludes the upper airways. The cannula is washed     every day from once to several times depending on the patient's secretions production and it     is usually replaced every week. The second replacement takes place about 10 days after     surgery. Patient education takes place at every replacement in order to empower him/her and     in consequence to increase living comfort. This empowerment is achieved at the 4th or 5th     replacement, at best. Because of the risks and complications related to tracheotomy and     because of the concerned vital function, the cannula replacement leads to anxiety especially     during the first replacements. Usual patient's anxiety management consists in reassuring the     patient during the replacement. In other situations, patients' anxiety management would be     drugs, however due to sedative and anxiolytic drugs' adverse events and to the need to     maintain optimal breathing, they are not used in first intention. Our choice is to use     conversational hypnosis during cannula replacement as it has already demonstrated interesting     effects in pain and anxiety. Conversational hypnosis does not present an induction phase like     in so-called hypnosis, it aims at leading the patient to perceive his/her world differently     with only a slight consciousness alteration.   "
256467|NCT02991885|"     The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1     subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the     safety and tolerability in adolescents and children with peanut allergy.   "
256468|NCT02970942|"     Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once     daily versus placebo in subjects with non-alcoholic steatohepatitis   "
256469|NCT03145051|"     Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and     tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution     both administered with Respimer® Netiflow® medical device among patients aged ≥ 11 years and     older with cystic fibrosis and suffering from chronic rhinosinusitis.   "
256472|NCT02969525|"     This is a study to evaluate the dose response based on the efficacy, safety and tolerability     of bimekizumab in subjects with active psoriatic arthritis.   "
256473|NCT02963909|"     Phase 1 study to evaluate two doses of Alum Adjuvanted Zika Virus Purified Inactivated     Vaccine (ZPIV) administered 28 days apart. The study will enroll 75 flavivirus naïve healthy     adult subjects into 3 equal groups sequentially. Each group will include 20 ZPIV recipients     and 5 placebo recipients. Group 1 will receive two ZPIV or placebo doses 28 days apart. Those     in Group 1 who consent to a third ZPIV dose will receive 5.0 mcg dose of ZPIV or placebo     administered IM on Day 224. Group 2 subjects will receive a two-dose regimen of IXIARO® 28     days apart; two ZPIV or placebo doses three months later 28 days apart. Those in Group 2 who     consent to a third ZPIV dose will receive it on Day 336. Group 3 subjects will receive one     dose of YF-VAX® followed three months later by two ZPIV or placebo doses 28 days apart. Those     in Group 3 who consent to a third ZPIV dose will receive it on Day 308. In each group, those     who do not agree to receive the third ZPIV dose will be followed based on the schedule. The     primary objectives are: 1) To evaluate the safety and reactogenicity of a two-dose homologous     prime boost regimen of ZPIV among flavivirus-naïve, YF-VAX® primed, and IXIARO® primed     subjects; 2) To evaluate the safety and reactogenicity of a third dose of ZPIV in consenting     subjects.   "
256474|NCT02963506|"     This is a study to evaluate the efficacy and safety of different doses of bimekizumab in     subjects with active Ankylosing Spondylitis (AS).   "
256475|NCT02959086|"     The purpose of this study is to describe the morbidity, mortality, disability and survival     rate in Shanghai adolescents and children with cancer diagnosed since January 2002.   "
256476|NCT02999100|"     The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of     reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This study     is being conducted to further assess safety and tolerability of inhaled oxytocin, and to     characterize the drug levels of inhaled (IH) oxytocin when compared to oxytocin administered     as standard of care. Two groups of subjects will be enrolled. Group 1 will enroll pregnant     women, who will be randomized to receive either IH or intramuscular (IM) oxytocin as active     management of the third stage of labour (after the baby is born). Group 2 will enroll     non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous     (IV) oxytocin in a cross over design over two dosing sessions This group will evaluate the     safety and tolerability of IH and IV oxytocin.   "
256477|NCT02948959|"     Primary Objective:      To evaluate the efficacy of dupilumab in children 6 to <12 years of age with uncontrolled     persistent asthma.      Secondary Objectives:      To evaluate in children 6 to <12 years of age with uncontrolled persistent asthma:        -  The safety and tolerability of dupilumab.        -  The effect of dupilumab in improving patient-reported outcomes (PROs).        -  The dupilumab systemic exposure and incidence of anti-drug antibodies.        -  To explore the association between dupilumab treatment and pediatric immune responses to          vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal          trivalent/quadrivalent influenza vaccine.   "
256478|NCT02948244|"     This multi-centre, randomised, double-blind, placebo-controlled crossover trial will compare     changes in strength-related motor function following treatment with creatine monohydrate to     treatment with placebo, as measured by the Motor Function Measure, from baseline to 12 weeks.     Eligible subjects will undergo baseline assessments then will be randomised to either     creatine monohydrate therapy or placebo for three months, followed by a six week wash-out     period, then crossover to a further three months of therapy with either placebo or creatine.     Subjects will undergo clinical assessments and study safety assessments at the beginning and     end of each treatment period. The study will begin recruitment in early 2017.   "
256479|NCT02938585|"     This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy     of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe     haemophilia A (FVIII≤1%).   "
256480|NCT02958527|"     SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL     PRACTICE   "
256481|NCT02936037|"     The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the     disability of patients suffering from progressive multiple sclerosis and especially those     with gait impairment.   "
256482|NCT02932410|"     This is a prospective, multicenter, open-label, randomized, controlled, parallel group,     group-sequential, event-driven Phase 3 study to evaluate efficacy, safety and     pharmacokinetics (PK) of macitentan in children.   "
256483|NCT02927873|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the     respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular     (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 17     months.   "
256484|NCT02923726|"     The primary objective is to understand the role of antitachycardia pacing (ATP) in primary     prevention patients indicated for ICD therapy and programmed according to current guidance of     higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in     subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only     to assess equivalency.   "
256485|NCT02923167|"     This is an intervention study including a baseline data collection, 6 weeks of a training     intervention with robotic-assisted manual training, a post-intervention data collection, and     a 4 weeks post-intervention follow-up data collection. The study will be conducted in the     Motion Analysis Laboratory at Spaulding Rehabilitation Hospital, Boston, MA.This study aims     to assess the effectiveness of a robot-assisted training on hand function and quality of life     in children with cerebral palsy. Additionally, the investigators will study the relationship     between muscle synergies and the outcomes of robot-assisted training.   "
256486|NCT02921256|"     This randomized phase II trial studies how well veliparib works with combination chemotherapy     and radiation therapy in treating patients with rectal cancer that has spread from where it     started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink     tumors. Giving veliparib with combination chemotherapy and radiation therapy may kill more     tumor cells and giving it before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed.   "
256487|NCT02912468|"     Primary Objective:      To evaluate the efficacy of dupilumab compared to placebo on a background of mometasone     furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and     endoscopic nasal polyp score (NPS) in patients with bilateral nasal polyposis (NP). In     addition for Japan, reduction in computed tomography (CT) scan opacification of the sinuses     will be also a coprimary objective.      Secondary Objectives:        -  To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).        -  To evaluate the efficacy of dupilumab in improving sense of smell.        -  To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses          (primary objective for Japan).        -  To evaluate ability of dupilumab in reducing proportion of patients requiring treatment          with systemic corticosteroids or NP surgery.        -  To evaluate the effect of dupilumab on patient reported outcomes and health related          quality of life outcome by sinonasal outcome test-22 (SNOT-22).        -  To evaluate the effect of dupilumab in the subgroups of patients with prior surgery and          co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated          respiratory disease [NERD]).        -  To evaluate residual effect in follow up.        -  To evaluate the safety of dupilumab in patients with bilateral NP.        -  To evaluate functional dupilumab concentrations (systemic exposure) and incidence of          treatment-emergent anti-drug antibodies.   "
256488|NCT02906930|"     This trial is conducted globally. The aim of this trial is to investigate efficacy and safety     of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with     diet and exercise only.   "
256489|NCT02907619|"     This study is an open-label extension to protocol B5161002 and will provide an assessment of     the long term safety, efficacy, pharmacodynamics and pharmacokinetics of intravenous dosing     of PF 06252616 in boys with Duchenne muscular dystrophy. Approximately 105 eligible subjects     will be assigned to receive a monthly individualized maximum tolerated dose based on their     tolerability profile/data from B5161002. This study will not contain a placebo comparator.     Subjects will undergo safety evaluations (Laboratory, cardiac monitoring, physical exams,     x-ray, MRI), functional capacity evaluations (4 stair climb, range of motion, strength     testing, Northstar Ambulatory Assessment, upper limb functional testing, six minute walk test     and pulmonary function tests) and pharmacokinetic testing.   "
256490|NCT02905006|"     This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled,     parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics     (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with     moderate to severe chronic plaque psoriasis in order to guide the selection of doses and     clinical indices in the Phase 3 development program.   "
256491|NCT02924688|"     A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA® dry powder     inhaler (DPI) is being developed by GlaxoSmithKline (GSK) with the aim of providing a new     treatment option for the management of asthma by improving lung function, health-related     quality of life (HRQoL) and symptom control over established combination therapies. This is a     phase III, multi-centre, active-controlled, double-blind, parallel-group study to compare the     efficacy, safety and tolerability of the FDC of FF/UMEC/VI with the FDC of FF/VI. This study     has 5 phases: Pre-Screening (Visit 0), Screening/Run-in, Enrolment/Stabilization,     Randomization/Treatment, and Follow up. At Visit 1 (Screening), subjects meeting all protocol     defined inclusion/exclusion criteria will enter a 3-week run-in period and will receive fixed     dose inhaled corticosteroid/long-acting beta agonist (ICS/LABA) (fluticasone/salmeterol,     250/50 micrograms (mcg), via the DISKUS® DPI) one inhalation twice a day. At Visit 2     (Enrolment), eligible subjects will be enrolled into the 2-week stabilization period to     receive FF/VI (100/25 mcg via the ELLIPTA DPI once a day, in the morning). At the conclusion     of the stabilization period (Visit 3), all subjects who meet the pre-defined randomization     criteria will be randomized 1:1:1:1:1:1 during the treatment period to receive either     FF/UMEC/VI (100/62.5/25 mcg; 200/62.5/25 mcg; 100/31.25/25 mcg; 200/31.25/25 mcg) or FF/VI     (100/25 mcg; 200/25 mcg) via the ELLIPTA DPI once daily in the morning. The duration of the     treatment period is variable but will be a minimum of 24 weeks and a maximum of 52 weeks.     Subjects will have up to 6 on-treatment clinic visits scheduled at Visits 3, 4, 5, 6, 7 and     8/End of Study (EOS) (Weeks 0, 4, 12, 24, 36 and 52, respectively). A follow-up visit will be     conducted approximately 7 days after the end of treatment period or, if applicable, after the     early withdrawal visit. Subjects will be provided with short acting albuterol/salbutamol to     be used on an as-needed basis (rescue medication) throughout the study. Approximately 2250     subjects will be randomized, with approximately 375 subjects randomized to each of the 6     double-blind treatment arms to ensure approximately 337 evaluable subjects per treatment arm.     DISKUS and ELLIPTA are registered trademarks of GSK groups of companies.   "
256492|NCT02898454|"     Primary Objective:      To evaluate the efficacy of dupilumab compared to placebo on a background of mometasone     furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and     endoscopic nasal polyposis score (NPS) in patients with bilateral nasal polyposis (NP). In     addition for Japan, reduction in computed tomography (CT) scan opacification of the sinuses     will be also a co-primary objective.      Secondary Objectives:        -  To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).        -  To evaluate the efficacy of dupilumab in improving sense of smell.        -  To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses          (Primary objective for Japan).        -  To evaluate ability of dupilumab in reducing proportion of patients requiring treatment          with oral corticosteroids or NP surgery.        -  To evaluate the effect of dupilumab on patient reported outcomes and health related          quality of life outcome by sinonasal outcome test-22 (SNOT-22).        -  To evaluate efficacy with various regimen.        -  To evaluate the effect of dupilumab in the subgroups of patients with prior surgery and          co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated          respiratory disease [NERD]).        -  To evaluate the safety of dupilumab in patients with bilateral NP.        -  To evaluate functional dupilumab concentrations (systemic exposure) and incidence of          treatment-emergent anti-drug antibodies (ADA).   "
256493|NCT02890992|"     Primary Objective:      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels     after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) patients age     of 8 to 17 years, with LDL-C ≥130 mg/dL (3.37 mmol/L) on optimal stable daily dose of statin     therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in     case of intolerance to statins for at least 4 weeks prior to the screening period.      Secondary Objectives:        -  To evaluate the safety and tolerability of alirocumab.        -  To evaluate the pharmacokinetics profile of alirocumab.        -  To evaluate the effects of alirocumab on other lipid parameters.   "
256540|NCT02748369|"     This is a pilot study to establish an arterial venous methodology to measure the activity of     the TCA cycle or flux directly in tissues of human beings. It will also perform correlative     studies to study the proteome, metabolome, oxygen consumption, carbon dioxide production and     exosomes derived from the arterial venous supply of tissues with correlation to the TCA cycle     activity.   "
256498|NCT02877784|"     Oculopharyngeal muscular dystrophy (OPMD) is a rare myopathic disease that results in     progressive degeneration of the oral and pharyngeal muscular, resulting in severe dysphagia     and dysarthria. OPMD is considered a rare disease; therefore, limited research is available     on the natural progression of the disease or the utility of biomarkers to identify swallowing     impairment. The aim of this study is:        1. To identify accurate, reliable and non-invasive clinical markers of swallowing          impairment        2. To determine the discriminate ability of these markers to identify impairments in          swallow safety and swallowing efficiency.   "
256499|NCT02877498|"     Neuroparalytic snake envenomation results in severe muscle weakness and respiratory failure.     Treatment requires administration of anti-snake venom and supportive care in the form of     invasive mechanical ventilation. Whether using adaptive support ventilation (a closed loop     mode of ventilation) in comparison to volume controlled ventilation will shorten the duration     of ventilation remains undetermined. The current study is planned to compare adaptive support     ventilation (ASV) mode of ventilation versus volume controlled ventilation (VCV) during     invasive mechanical ventilation for the management of respiratory failure secondary to     neuroparalytic snake envenomation.   "
256500|NCT02865187|"     SUMMARY:      Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among reproductive age     women with a prevalence as high as 15%. The clinical symptoms of PCOS including menstrual     dysfunction, infertility, hirsutism, alopecia, acne, and the possible increased risk of     diabetes and cardiovascular disease have been reported to be significant contributors to     psychological morbidity and impact health-related quality of life. For women with PCOS, the     changes in physical appearance and the associated mood disorders appear to be deleterious for     sexual function.      Vitamin D deficiency (<20 ng/ml serum concentration of 25[OH]D), which affects from 67% to     85% of women,4 is closely linked to symptoms of PCOS. The main physiologic role of vitamin D     is to regulate calcium and phosphorus homeostasis and to promote bone health. Although there     has been an increase in awareness of the importance of sexual dysfunction and QoL in women     with PCOS, few studies have evaluated the outcomes of treatment for PCOS upon sexual and     subjective health status of women.      The goals of this study are:        1. To evaluate the prevalence of sexual dysfunction (SDy) in women with Polycystic Ovarian          Syndrome (PCOS)        2. To determine the effects of Vitamin D therapy, with and without hormonal contraceptives,          on SDy in women with PCOS in the absence of depression.      METHODS:      The study will enroll 60 women diagnosed with PCOS and reporting SDy at the Wright State     Physicians (WSP) OB-GYN Practice and the WSP Family Medicine Practice.      All participants will take vitamin D 600IU/day and will choose between hormonal and     non-hormonal contraceptive methods (target of 30 participants in each group). Participants     will complete three study visits (Initial, Month 3, and Month 6). Vitamin D levels will be     drawn at the beginning of the study and again at 3 and 6 months after initiation of vitamin D     therapy. Each participant will be asked to complete the Female Sexual Function Index (FSFI)     and the Beck Depression Inventory (BDI) prior to initiation of treatment and again at 6     months.   "
256501|NCT02860988|"     The purpose of this study is to determine differences among incarcerated or recently     incarcerated fathers who receive targeted services and those who do not.   "
256502|NCT02883413|"     The purpose of the current study is to investigate the role of Cognitive Remediation Therapy     (CRT) as a pre-treatment intervention for adolescents who are hospitalized for Anorexia     Nervosa (AN). The primary aims are to determine if CRT can result in greater treatment     engagement post-discharge, increased rate of weight gain post-discharge, reduction in symptom     accommodation, and increased behavioral flexibility in adolescents and parents.   "
256503|NCT02847650|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751     in Parkinson's disease patients at early stage of the disease.   "
256504|NCT02844933|"     The primary objectives of this study are to assess the efficacy of Cannabidiol Oral Solution     on hyperphagia-related behavior in subjects with Prader-Willi Syndrome (PWS), and to assess     the efficacy of Cannabidiol Oral Solution on body weight in subjects with PWS.   "
256505|NCT02849080|"     This trial is globally conducted. The aim of this trial is to investigate Efficacy and Safety     of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus     Sitagliptin in Subjects with Type 2 Diabetes Mellitus.   "
256506|NCT02844517|"     The objective of the study is for clinical staff to gain experience using the proposed     artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home     usability prior to initiating a large randomized controlled trial.   "
256508|NCT02836496|"     Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is     considered to play an important part in the pathology, including eosinophilic asthma, HES,     and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil     counts is observed in association with mepolizumab administration, with concomitant clinical     improvement. This is a 32-week treatment period, randomized, double-blind,     placebo-controlled, parallel group, multicentre study of mepolizumab in adolescent and adult     subjects with severe HES receiving standard of care (SoC) therapy. This study will     demonstrate the efficacy of mepolizumab compared with placebo based on maintenance of control     of HES symptoms during the treatment period. The study will comprise of a screening period of     up to approximately 4 weeks followed by a 32-Week study treatment period (subjects will be     randomized 1:1 to placebo or mepolizumab) and up to 8-week additional follow-up period (12     weeks after the last dose of study treatment).   "
256509|NCT02834013|"     This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors.     Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of     tumor cells to grow and spread.   "
256510|NCT02842671|"     The investigators are evaluating the implementation and the effectiveness of a medical     student staffed support program (ASAP) for children diagnosed with Autism Spectrum Disorder     coming into Penn State Hershey Children's Hospital for a medical procedure. The ASAP program     involves training and assigning a medical student as an Ambassador to help advocate for the     special needs of a child with ASD. This study is designed to compare patient satisfaction of     children and families who are assigned an Ambassador to those who are not assigned an     Ambassador during the procedure. The secondary objectives are to measure overall medical     student satisfaction with the program, medical student career interests before and after     participation, and medical student comfort level interacting with children with ASD before     and after participation.   "
256511|NCT02833610|"     This research study is studying a possible therapy as a possible treatment for the     consequences of Multiple Myeloma with renal insufficiency.   "
256512|NCT02831673|"     This study will compare safety, efficacy, and tolerability of a two drug regimen of     dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two     nucleoside reverse transcriptase inhibitors (Tenofovir [TDF]/Emtricitabine [FTC] fixed dose     combination [FDC]) administered once daily in human immunodeficiency virus (HIV) 1 infected     adult subjects that have not previously received antiretroviral therapy. The study is     designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC regimen to that     of DTG plus TDF/FTC FDC and will characterise the long term antiviral activity, tolerability     and safety of DTG plus 3TC through Week 148. Approximately, 700 subjects will be randomised     1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Subjects will be stratified by screening HIV 1     ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation 4)     cell count.   "
256513|NCT02828358|"     This pilot phase II trial studies the side effects of azacitidine and combination     chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs     used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride,     cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium     succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine     work in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Giving more than one drug     may kill more cancer cells.   "
256514|NCT02826473|"     Neurocognitive Disorder (NCD) affects over 116'000 people in Switzerland and is frequently     unrecognized and underdiagnosed. Because missed and delayed diagnosis are associated with an     increased burden of disease health Service Research has prompted a discussion about     diagnostic guidelines and screening programs. Some argue that screening for NCD in primary     care is the optimal strategy to increase recognition rates; others consider test protocols     implemented into hospital admission assessments as more justified. There is no distinct     recommendation due to a lack of empirical data on the benefits and harms of cognitive testing     yet. This trial strives to fill this gap and provide information about the benefits, harms     and the economic case of routine cognitive testing for neurocognitive disorder in high risk     elective inpatients, in Switzerland.      The investigators hypothesize that, cognitive tested patients, compared with patients not     cognitive tested, will have higher health-related quality of life at 12months; and lower     medical health care costs at 18months.   "
256515|NCT02825589|"     Based on many previous data proving hypervolemia in chronic hemodialysis patients could lead     to sleep apnea and poor sleep quality. The investigators conduct this trial to evaluate     whether more accurate dry weight assessment with BIA in these patients can lead to better     sleep quality (measured by sleep actigraphy and questionnaires). The investigators will     enroll 30 chronic hemodialysis patients in hemodialysis unit of Ramathibodi hospital whose     age > 18 years with subclinical hypervolemic status and baseline Pittsburgh sleep quality     index (PSQI) score > 5 into study. Patients with bed-ridden status, alteration of     consciousness and unstable hemodynamics will be excluded. Then eligible patients will be     randomized into 2 groups, BIA-guided and standard clinical guided dry weight assessment. The     investigators will assess participants' dry weight at beginning of study, 3rd month and 6th     month. Sleep actigraphy parameters (eg. total sleep time, sleep efficiency), sleep     questionnaires score, left ventricular mass index by echocardiography, ambulatory blood     pressure monitoring and blood chemistry results were collected at beginning of study, the end     of 1st, 3rd and 6th month. The primary outcome is change of sleep actigraphy parameters     between the groups. The secondary outcomes are change of sleep questionnaires scores, change     of left ventricular mass index, change of ambulatory BP monitoring and also cardiovascular     complications between groups.   "
256516|NCT02844504|"     Breast cancer patients often suffer from long-term physical symptoms of weakness. In this     study, investigators propose to compare how two different low intensity physical exercise     training programs can improve handgrip strength for breast cancer patients with symptoms of     weakness. Using brain imaging, the study will also investigate changes in brain structure,     and muscle activity associated with handgrip.   "
256517|NCT02810990|"     The objective of the present study is to evaluate a new drug called bosutinib as it is     believed that this agent may be able to predict an excellent prognosis in patients that did     not obtain any benefit with other drugs before. Still, this needs to be proved and we hope     this study is able to do so.   "
256522|NCT02807259|"     Female sex workers (FSWs) frequently experience violence from their intimate partners     (non-paying lovers), which compromises their health and increases their the risk of infection     with HIV or other sexually transmitted infections. Samdevena Plus is a complex multi-level     intervention that works with FSWs, their intimate partners, the sex worker community and the     general population. The intervention aims to reduce partner violence and increase consistent     condom use within these relationships.      The intervention consists of: (i) couples counselling sessions between FSWs and their     intimate partners; (ii) separate group work among FSWs and intimate partners to increase     self-esteem and encourage reflection about violence; (iii) strengthening supportive crisis     management systems that address domestic and sex worker violence; (iv) training male     'champions' to encourage action against violence; and (v) training media to promote informed     discussions about violence and HIV risk.The program involves changing perceptions on     acceptability of physical violence as a form of discipline, challenging assumptions that give     men authority over women, and working with men and women to encourage new relationship models     based on equality and respect. The intervention will reach 800 FSWs and their intimate     partners living in 47 villages in north Karnataka, India. The evaluation uses a     cluster-randomized control trial design that introduces the intervention into half of     villages for the first 24 months and the remaining half receive the intervention thereafter.     The primary outcomes of the trial are: the proportion of FSWs who report: i) consistent     condom use in their intimate relationship; and ii) experiencing partner violence within the     past 6 months.   "
256523|NCT02798211|"     To demonstrate that the efficacy of secukinumab 300 mg at Week 16 is superior to placebo in     adult patients with active PsA based on the proportion of patients achieving an American     College of Rheumatology 20 (ACR20) response.   "
256524|NCT02795988|"     The Phase 1b study is an open-label, multicenter dose escalation study designed to assess the     safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131. The RP2D     will be evaluated in the dose expansion Phase 2 study.   "
256527|NCT02815488|"     CHF6297 is a potent and selective inhibitor of human MAP kinase p38 being developed as an     anti-inflammatory agent for the treatment of inflammatory airways diseases. The purpose of     this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of     single and repeat doses of CHF6297 as dry powder formulation in healthy subjects and in COPD     patients. This study is the first administration in humans.      The study will comprise four parts:      Part 1 will consist of two cohorts of healthy male subjects to assess the safety,     tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6297.      Part 2 will consist of four cohorts of healthy male subjects to assess the safety,     tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6297.      Part 3 will consist of one cohort of COPD patients to assess the safety, tolerability,     pharmacokinetics and pharmacodynamics of a repeat dose of CHF6297      Part 4 will consist of one cohort of healthy subjects to assess the anti-inflammatory effect     of a repeat dose of CHF6297 after LPS challenge.   "
256528|NCT02782949|"     This randomized phase IIb trial studies how well curcumin works in preventing gastric cancer     in patients with chronic atrophic gastritis and/or gastric intestinal metaplasia. Curcumin is     an antioxidant compound found in plants that may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
256529|NCT02769429|"     This study will answer the question whether there is a difference in the effects and     complication rates of ultrasound guided continuous interscalene block (CISB) and nerve     stimulation-guided continuous cervical paravertebral block (CCPVB). The aim of this study is     to evaluate the differences in efficacy and side effects - if any.   "
256530|NCT02764320|"     There are two commonly used treatment strategies for treating patients who have chronic     migraine with medication overuse. This study will compare the outcomes amongst patients     randomized to one of the two treatment strategies.   "
256531|NCT02761057|"     This randomized phase II trial studies how well cabozantinib-s-malate, crizotinib, volitinib,     or sunitinib malate work in treating patients with kidney cancer that has spread from where     it started to nearby tissue or lymph nodes or to other places in the body.     Cabozantinib-s-malate, crizotinib, volitinib, and sunitinib malate may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth.   "
256532|NCT02756247|"     The purpose of this study is to find out if the combination of buparlisib and ibrutinib will     lead to better treatment results in patients with relapsed or refractory Follicular lymphoma,     (FL) Mantle cell lymphoma (MCL) or Diffuse Large B-cell lymphoma (DLBCL). The investigators     are using buparlisib and ibrutinib because both drugs seem to block different proteins that     allow cancer cells to keep growing. Blocking these proteins may help by making the cancer     cells undergo cell death, which will stop uncontrolled tumor growth.   "
256533|NCT02754830|"     The purpose of this study is to evaluate the safety and tolerability of the study drug,     LY3303560. Side effects and laboratory results will be monitored. This study will involve     single doses of LY3303560 administered intravenously (IV), meaning into a vein or     subcutaneously (SC), meaning under the skin.      Screening is required within 28 days before the start of the study for healthy participants     and within 42 days before the start of the study for AD participants. The study requires     about 16 weeks of each participant's time including a 4 day clinical research unit (CRU)     admission and 10 follow-up appointments.      This is the first time that this study drug is being given to participants. This study is for     research purposes only, and is not intended to treat any medical condition.   "
256534|NCT02757937|"     Diabetes is one of the most common chronic illnesses among adults in the United States.     Internet-based interventions and health promotion websites for patients with Type 2 Diabetes     are typically low-cost, easily accessible, and attractive. The purpose of this study is to     determine whether participants' utilization of a health & wellness website focused on     diabetes self-management increases participants' self-reported self-efficacy toward managing     their Type 2 Diabetes through behavior change and self-reported medication adherence compared     to standard care.   "
256541|NCT02726958|"     Stress hyperglycaemia is a well-known risk factor of postoperative morbidity and mortality in     cardiac surgery. Recently, several authors have reported that increased blood glucose (BG)     variability could worsen the prognosis in this population.The transcatheter aortic valve     implantation (TAVI) is a low invasive procedure proposed as an alternative technique to     aortic valve replacement surgery in high-risk patients.      The aim of this study is to describe the incidence of stress hyperglycaemia and assess     whether BG variability could impact the outcome of patients undergoing TAVI.   "
256542|NCT02722603|"     This study evaluates the efficacy and safety of gabapentin relative to tramadol for the     treatment of chronic, neuropathic or mixed pain in the paediatric population. Children from 3     months to less than 18 years of age experiencing moderate to severe chronic pain will receive     either gabapentin or tramadol for 15 weeks. The difference in average pain scores between     treatment arms at the end of the treatment period will be assessed.   "
256543|NCT03270319|"     Comparison of volumetric measurements obtained by three dimensional echocardiography with     measurements obtained by thermodilution using a pulmonary artery catheter in the intensive     care unit.   "
256544|NCT03270995|"     Studies show that cancer survivors have unmet needs, the most frequently cited being fear of     recurrence (FCR). Moderate to high levels of FCR have been reported by as much as 49% of     cancer patients and are more prevalent among women. FCR is associated with psychological     distress, lower quality of life, and increased health care utilization. Little evidence     exists that these problems are being addressed by current medical management.   "
256545|NCT02757339|"     This study aims to evaluate the neurobiological basis of traumatic dissociation in a     cross-diagnostic sample of women who have histories of childhood abuse and neglect.   "
256546|NCT02794792|"     The main purpose of this study is to evaluate the efficacy in reducing glycated hemoglobin of     ipragliflozin in combination with metformin compared with metformin plus placebo in subjects     with type 2 diabetes mellitus who have inadequate glycemic control on metformin.   "
256547|NCT02718716|"     The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is     safe and tolerated in subjects with primary immune thrombocytopenia.   "
256550|NCT02688088|"     This study is known as a drug interaction study and is being done to see how abemaciclib     may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin,     dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each participant     will complete screening and four study periods, with the option to continue to receive     abemaciclib in a safety extension phase. All participants will complete a safety follow-up.   "
256551|NCT02685683|"     This study is designed to explore mechanism of action of mongersen (GED-0301) 160 mg once     daily in patients with active Crohn's Disease   "
256552|NCT02693093|"     The purpose of this study is to determine the safety and efficacy of NI-03.   "
256553|NCT02683148|"     DHEA is a natural allosteric inhibitor of glucose-6-phosphate dehydrogenase (G6PD). G6PD is a     key regulatory enzyme for the survival of synovial sarcoma. The investigators postulate that     they can inhibit the production of NADPH in synovial sarcoma and cause cell death by using a     naturally occurring G6PD inhibitor.   "
256554|NCT02697773|"     The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab     in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg)     at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study     also evaluates the safety of the treatment regimens.   "
256555|NCT02680574|"     A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance     treatment of anemia in subjects with NDD-CKD   "
256556|NCT02689934|"     A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a     red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium     longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of     improvement of the lipid profile and cardiovascular risk.   "
256557|NCT02687204|"     Blood clots that form in the extremities (deep venous thrombosis) and lungs (pulmonary     embolus) are feared complications of reconstructive surgery. One in ten patients with     symptomatic pulmonary embolus will be dead in 60 minutes. Patients with deep venous     thrombosis can develop the post-thrombotic syndrome, known to be a major driver of poor     quality of life. These phenomena, broadly known as venous thromboembolism (VTE), have     substantial downstream ramifications, and the US Surgeon General and the American Society of     Plastic Surgeons (ASPS), among others, have underscored the importance of VTE prevention in     surgical patients. Reconstructive surgery, most commonly performed to fix traumatic injuries     or defects after cancer excision, often involves borrowing tissue from adjacent or distant     areas on the body; reconstructive surgery patients can routinely have surgical injury     involving 20% or more of their total body surface area. Injury and resultant inflammation are     known to increase metabolism of certain drugs, including those used to prevent VTE after     surgery.      Enoxaparin is a blood-thinning medication that decreases likelihood of blood clot formation.     Previous research has shown that reconstructive surgery patients who are given enoxaparin     after surgery are less likely to develop VTE. However, despite receiving of a standard dose     of enoxaparin, many patients still develop this life-threatening complication. The     investigators believe that patients metabolize enoxaparin differently based on the degree of     surgical injury created during reconstruction, and seek to critically examine enoxaparin     metabolism in reconstructive surgery patients. The proposed research will evaluate how     enoxaparin affects the blood based on standard, ASPS-recommended dosing after reconstructive     surgeries; the investigators will also examine whether the extent of surgical injury alters     metabolism as well. Enoxaparin effectiveness will be tracked using anti-Factor Xa (aFXa)     levels. If subtherapeutic aFXa levels are observed, the study will also design, implement and     test a clinical enoxaparin dose-adjustment protocol to achieve appropriate post-operative     aFXa levels. Further research based on these data will examine reduction in VTE risk when     aFXa-driven enoxaparin dosing is used.   "
256617|NCT02810834|"     The central hypothesis of the Fueling Learning Through Exercise (FLEX) study is two     innovative school-based physical activity programs (a walking/running program and a classroom     activity break program) will increase school-time and total daily minutes children engage in     moderate-to-vigorous physical activity, relative to controls, and that children who attend     schools with these PA programs will demonstrate improved cognitive functioning, academic     achievement, and attendance, relative to controls.   "
256558|NCT02678351|"     This phase II/III trial studies gallium 68 Ga (68Ga)-prostate-specific membrane antigen     (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) in finding tumors in     patients with prostate cancer undergoing surgery that tend to spread quickly     (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures,     such as PET/MRI, may help find and diagnose prostate cancer and find out how far the disease     has spread. Radioactive drugs, such as gallium Ga 68-PSMA, binds to tumor cells that have     specific receptors, and may allow doctors to see smaller tumors than the standard of care     contrast-enhanced computed tomography (CT) or MRI scan.   "
256559|NCT02687542|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751     in Parkinson's disease patients who experience motor-fluctuations.   "
256560|NCT02683785|"     This is a randomized, Phase IIa, multicentre, double-blind, placebo-controlled parallel group     study with the primary objective to assess the efficacy potential of GSK3196165 on pain, in     subjects with active inflammatory hand osteoarthritis (HOA).      Approximately 40 subjects will be enrolled into the study, following a screening period of up     to 4 weeks. The total treatment period will be 12 weeks, with the follow up period completing     at Week 22. At least 40 subjects will be randomized across the two treatment arms, to either     placebo or GSK3196165 in a 1:1 ratio.   "
256561|NCT02663700|"     This study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation trial     of Sanaria's irradiated sporozoite vaccine (PfSPZ vaccine). The primary objective of this     protocol is to determine the safety and reactogenicity of the PfSPZ Vaccine in     malaria-experienced healthy adults. The study duration shall be 34 months and subject     participation duration shall be 15-26 months.   "
256562|NCT02659163|"     The high prevalence and burden of cardiometabolic disease underlie the urgent need to     identify novel approaches to managing and preventing cardiometabolic disease and risk. This     project will test an innovative use of mobile health technology to implement a closed-loop     feedback system that collects objective patient-generated data and provides clinical     recommendations to modify contributing health behaviors. In addition to improving care for     cardiometabolic disease, the tools and methods developed by this study for collecting patient     data and providing clinical feedback could also easily be adapted and applied to a range of     other health conditions, and are thus highly relevant to public health.   "
256563|NCT02648347|"     A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of     anemia and maintenance of hemoglobin (Hb) in subjects with NDD-CKD   "
256564|NCT02642042|"     This phase II trial studies how well trametinib and docetaxel work in treating patients with     stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come back.     Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving trametinib with docetaxel may work better in treating     non-small cell lung cancer.   "
256565|NCT02641392|"     The purpose of this study is to assess long-term safety data of GED-0301 for a period of up     to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3     GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of     age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will     receive active treatment, this study is double-blinded for the entire 208 weeks for the     purpose of preserving the blind of the subject's treatment allocation in the initial, core     Phase 3 GED-0301 study.   "
256566|NCT02629471|"     Background The goal of this study is to examine the human visual and cognitive performance     under the effect of bright light pulses. Exposure to visual stimulation of such pulsation may     interfere with cognitive function and at certain situations this may be noticeable and may     interfere with our judgment and abilities. In some of them visual or cognitive impairment     from exposure to bright light flashes may result in catastrophic outcome due to the high-risk     situation e.g. road accidents. Ocular exposure to a bright light can result in profound     momentary transitional loss of vision. The light sources employed for visual stimulation in     this study will be restricted to the range consistent with reversible effects (e.g. glare     and flash insensitivity or flash blindness).      The impact of an exposure to bright light depends not only on the exposure level and     frequency, but also on the exposed individual's activity, psychological state, adaptation     level and visual task. Glare is primarily caused by the scattering of light within the eye     due to the imperfect transparency of the optical components of the eye and to a lesser extent     by diffuse light passing through the scleral wall or the iris. The scattered light overlays     the retinal image, thus reducing visual contrast. Excessive glare may impair visual function     and lead to temporary disability.      The above mentioned effects of exposure to light and pulsating light stimulus on the visual     system and cognition were studied in detail by a number of groups. These studies indicate     that the visual and cognition effects of pulsating light are a function of the following     parameters: pulse duration, light intensity and pulse frequency.   "
256567|NCT02635269|"     This study aims to characterize the pathophysiological mechanisms of 21 different metabolic     myopathies. The study will focus on exercise capacity and the metabolic derangement during     exercise.   "
256579|NCT02595905|"     This randomized phase II trial studies how well cisplatin works with or without veliparib in     treating patients with stage IV triple-negative breast cancer and/or breast cancer (BRCA)     mutation-associated breast cancer. Drugs used in chemotherapy, such as cisplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Veliparib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if     cisplatin is more effective with or without veliparib in treating patients with     triple-negative and/or BRCA mutation-associated breast cancer.   "
256580|NCT02595944|"     This randomized phase III trial studies how well nivolumab after surgery and chemotherapy     work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal     antibodies, such as nivolumab, may stimulate the immune system in different ways and kill     tumor cells remaining after surgery and standard of care chemotherapy.   "
256568|NCT02663245|"     The intensification of the management for the control of glycaemia and other risk factors in     patients with type 2 diabetes (DM2) results in a reduction of diabetes-related complications.      The strategy to increase the competences of primary care professionals to improve health care     has been mainly prompted by the current context of limited resources and restricted access to     specialty care.      This study aims to evaluate the effectiveness and cost-effectiveness of an integral     intervention carried out by primary care professionals with the following components:        1. detection of patients with poor diabetic control;        2. introduction of a specific consultation on diabetes followed by virtual and telephone          specialist support;        3. introduction of other measures to overcome patients and professionals barriers to          treatment.      The main objective of the study is to determine if glycaemic control as measured by the mean     concentration of HbA1c of poorly controlled patients improves when these patients are     evaluated and treated in primary care under the integral strategy proposed in this study. The     INTEGRA project also includes Phase 1 (qualitative research study), which is aimed at     identifying viable strategies to suppress barriers to treatment; these strategies have been     included to the intervention study (phase 2).      Phase 2 is a controlled, quasi-experimental intervention that involves 9 primary care centres     of 3 regions (Lleida, Girona, Barcelona). The participants are patients with DM2 with poor     glycaemic control that meet all the inclusion criteria and sign the informed consent. The     intervention study will have three arms: (1) Control Group; (2) Intervention Group 1     (diabetes specific consultation + additional measures originated in phase 1; and (3)     Intervention Group 2 (additional measures originated in phase 1).      Phase 1 has been conducted during the last 6 months previous to the initiation of the     proposed intervention study and consisted of a qualitative design (individualized interviews     with randomly selected patients in each of the participating centers); this qualitative study     has contributed to design the final intervention applied on phase 2, particularly,     implementing additional measures as coaching sessions to health professionals of the     participating centers and automated messaging to patients with reminder and motivational     objectives.      Phase 2 consists of a recruitment period of 6 months, followed by a 12-month follow-up for     each patient   "
256569|NCT02625090|"     The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy     during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant     focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be     explored.   "
256585|NCT02584322|"     Currently, at the CHUM - Notre-Dame Hospital, there is no standardized patient care pathway     for patients undergoing Video Assisted Thoracic Surgery (VATS) lobectomy. The investigators     goal is to implement an Enhanced Recovery Program (ERP) for patient undergoing VATS     lobectomy.      The care given to patient prior to the implementation of this protocol was different amongst     patients and depended on the surgeon's preferences. The implementation of this ERP will     permit a reproducible and routine management for patients following their surgery.   "
256586|NCT02581878|"     To establish a recommended dose of BAY1862864 Injection and to investigate how the study drug     acts in the body, on the cancer cells and how safe it is in patients with advanced     non-Hodgkin's lymphoma (NHL)   "
256678|NCT02184546|"     The purpose of this study is to determine the impact that treatment with a cellular     concentrate derived from an individual's own fat, known as the stromal vascular fraction     (SVF), has on the quality of life of people with Parkinson's disease (PD). SVF contains     components with regenerative properties, including stem cells that may be capable of     ameliorating specific disease conditions. This study is designed to evaluate quality of life     changes in individuals with PD for up to 12 months following SVF treatment.   "
256570|NCT02669654|"     Background: At present pneumonia and malnutrition have become the leading causes of mortality     among <5-year-old children in developing countries. World Health Organization standard     management of severe pneumonia and severe malnutrition requires hospitalization for     supportive care. As many developing countries including Bangladesh do not have enough     pediatric hospital beds to accommodate the demand for admission of all children with severe     pneumonia and malnutrition, Investigators developed alternative treatment option such as Day     Care Approach, for those children who cannot be hospitalized, but are too sick to be managed     in the community. After successful Day Care Approach of management of efficacy trials with     severe childhood pneumonia and severe malnutrition, the next step is to conduct an     effectiveness trial under real life condition, i.e. within the Health Systems of     Bangladesh.      Burden: Pneumonia is the leading cause of mortality in developing countries, being     responsible for 1,368,000 (18%) of annual 7.6 million deaths, 95% occurring in developing     countries. Similarly, malnutrition is a major health problem with an estimated 1.7 & 3.6     million children dying annually because of Severe Acute Malnutrition & Moderate Acute     Malnutrition, respectively.      Objectives: To assess & implement the Day Care Approach of management of severe childhood     pneumonia with or without Moderate Acute Malnutrition and/or severe underweight into existing     Health Systems of Bangladesh as a safe & cost effective alternative to Existing Treatment.      Methods: A cluster randomized controlled trial will be conducted in Bangladesh by involving     16 clusters (Wards) in Dhaka & 16 clusters (Unions) in rural areas that will be randomly     assigned to intervention & control arm. Children with severe pneumonia will be enrolled in     (i) Tikatuli, (ii) Circular Road, (iii) Dhamrai Upazilla of Dhaka, (iv) Karimganj Upazillas     to one of two management schemes: (i) Existing Treatment in control clusters or (ii) Day care     Approach in intervention clusters by involving Comprehensive Reproductive Health Centres in     urban and Health and Family Welfare Centres in rural areas.      Outcome variables:        -  Primary: clinical treatment failure by day 6        -  Secondary:           (i) Treatment failure between day 7-14 in children who are well on day 6 (ii) Cost          effectiveness (iii) Referrals to hospitals (iv) Deaths   "
256571|NCT02716311|"     Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was     a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth     Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of     EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved     in several phase III trials with gefitinib, erlotinib or afatinib.      Nevertheless, all patients will progress after 9 to 12 months of treatment due to the     appearance of a treatment resistance.      Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to     erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all     HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that     afatinib delay the appearance of resistance.      Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition     of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The     hypothesis of this study is that the combination between cetuximab and afatinib will permit     to delay or decrease the appearance of resistances.   "
256572|NCT02639091|"     Determine the safety, tolerability and maximum tolerated dose of anetumab ravtansine (BAY     94-9343) in combination with pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 in subjects with     mesothelin-expressing predominantly epithelial mesothelioma or nonsquamous non-small-cell     lung cancer.   "
256573|NCT02610413|"     This research trial studies whole exome sequencing in finding causative variants in germline     deoxyribonucleic acid (DNA) samples from patients with hypertension receiving bevacizumab for     breast cancer. Studying samples of germline DNA in the laboratory from patients with     hypertension receiving bevacizumab for breast cancer may help doctors learn about changes     that occur in DNA and identify biomarkers related to hypertension.   "
256574|NCT02610439|"     This research trial studies whole exome sequencing in finding causative variants in germline     deoxyribonucleic acid (DNA) samples from patients with peripheral neuropathy receiving     chemotherapy for breast cancer. Studying samples of germline DNA in the laboratory from     patients with peripheral neuropathy receiving paclitaxel for breast cancer may help doctors     learn more about changes that occur in DNA and identify biomarkers related to peripheral     neuropathy.   "
256575|NCT02610426|"     This research trial studies whole exome sequencing in finding causative variants in germline     deoxyribonucleic acid (DNA) samples from patients with congestive heart failure receiving     therapy for breast cancer. Studying samples of germline DNA in the laboratory from patients     with congestive heart failure receiving therapy for breast cancer may help doctors learn more     about changes that occur in DNA and identify biomarkers related to congestive heart failure.   "
256576|NCT02607306|"     This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety     of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with     type 2 diabetes mellitus.   "
256577|NCT02605122|"     This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the     safety and efficacy of solithromycin in children and adolescents with community-acquired     bacterial pneumonia (CABP).   "
256578|NCT02595918|"     This pilot phase I trial studies the side effects of nivolumab and how well it works in     treating patients with high-risk kidney cancer that has not spread to other places in the     body. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells     to grow and spread.   "
256584|NCT02585687|"     Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide with an incidence of     500 000 cases per year. HCC most commonly appears in a context of liver chronic disease     (patient with chronic viral hepatitis (hepatitis B or hepatitis C) or with cirrhosis).     Surgical resection and liver transplantation concern patients with early stage and are the     only curative treatments. Transcatheter arterial chemoembolization, Radiation Therapy and     antiangiogenics treatments concern patients with inoperable lesions (palliative treatments).      Antiangiogenic treatments enable to inhibit the angiogenesis process and thus interrupt the     blood supply to the tumor. In clinical practice, the efficacy of anti-angiogenic agents is     usually assessed by methods based on morphological medical imaging. The measures of each     target lesion are obtained by Response Evaluation Criteria In Solid Tumor (RECIST) criteria     and WHO.      However, these morphological measures are not fully evaluated. An alternative to these is the     functional medical imaging which assess changes before that a diminution of tumor size is     detectable. Since these treatments induce generally necrosis without modification of initial     tumor size, the new technologies of functional medical imaging are particularly adapted to an     early evaluation of the response to treatments which may improve patient management.      In this context, liver Perfusion MRI needs to be assessed in its capacities to early predict     the response of antiangiogenic treatments.      Positive results will enable to adapt therapy in order to improve overall survival of     patients and avoid expensive treatments which may turn out to be inefficient and generating     important side-effects.   "
256587|NCT02578875|"     Background:      Researchers are testing a new way to find out what causes infections in people in hospitals.      Current techniques use chemical or biological tests on a person s samples. Samples are blood,     tissue, stool, saliva, urine, etc. Researchers are testing new techniques that use a device     called MiSeq. It can sequence all of the DNA (genetic material) in a sample. This may show     microorganisms, such as bacteria, fungi, and viruses that cause infection. Researchers want     to know if the new test works as well or better than current tests. They will do this by     looking at about 250 samples.      Objective:      To test if MiSeq works as well as or better than current tests to identify microorganisms     that cause infection.      Eligibility:      NIH patients whose samples have been sent to the Microbiology Service s lab for routine     microbiologic testing.      Design:      Participants will consent to have samples they gave as part of their routine medical care     used in the study. For those under age 18, a parent or legal guardian will consent.   "
256588|NCT02567435|"     This randomized phase III trial studies how well combination chemotherapy (vincristine     sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan     hydrochloride) works compared to combination chemotherapy plus temsirolimus in treating     patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and     has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Combination     chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. It is not yet known whether combination chemotherapy or     combination chemotherapy plus temsirolimus is more effective in treating patients with     intermediate-risk rhabdomyosarcoma.   "
256589|NCT02566369|"     Assessment of the efficacy and safety of CD5789 50μg/g cream applied once daily for 12 weeks     in subjects with acne vulgaris.   "
256590|NCT03029325|"     Investigators use a genome-wide approach within a case-control design to identify SNPs that     show evidence of association with lung cancer risk and survival.   "
256591|NCT02559284|"     The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution     and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER®     NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at     14 days post-surgery.   "
256592|NCT02586987|"     This is a Phase I, open-label, multi-centre, drug combination study of double and triple     combination oral selumetinib (AZD6244 Hyd-sulfate) plus intravenous (IV) MEDI4736 and oral     selumetinib plus IV MEDI4736 and IV tremelimumab in patients with advanced solid tumours.   "
256593|NCT02556788|"     Assessment of the efficacy and safety of CD5789 50µg/g cream applied once daily for 12 weeks     in subjects with acne vulgaris.   "
256618|NCT02441673|"     Post Anaesthetic Shivering is a common complication of Subarachnoid block. It is graded based     on it's severity and has been known to cause various problems like patient's discomfort,     hypoxia, change in hemodynamic variables of the patient and poor wound healing. This problem     has been managed via pharmacologic and non-pharmacologic means. Non-pharmacologic modalities     involve options aimed at warming the patient. Pharmacologically, opioids are used more     commonly to prevent and treat this condition. This then introduces the side effect of     nausea/vomiting and sedation which may reduce overall patient's satisfaction on the     perception of the Subarachnoid block. It is for this reason that Nefopam - a centrally acting     non-opioid, non-steroidal anti-inflammatory drug (NSAID) analgesic, relatively new drug in     the Nigerian market with significant anti-shivering effect is compared with a well     established opioid like Tramadol. Having similar cost profile, the option of replacing     Tramadol with Nefopam especially in conditions where the patient is more hemodynamically     unstable is considered in this project.   "
256619|NCT02439008|"     This study will follow-up immune cell populations, secreted factors and released nanovesicles     in the blood before, during and after high dose radiation therapy which should give new     information of the efficacy of the hypofractionated high dose radiation therapy and a     rationale for adjuvant immunotherapy.   "
256594|NCT02555371|"     Primary objective of the study is to evaluate whether patients with severe eosinophilic     asthma who have received long-term treatment with mepolizumab (at least 3 years) need to     maintain treatment with mepolizumab to continue to receive benefit. Subjects who participated     in the open-label studies MEA115666 or 201312 with at least 6 months of treatment with     mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed doses of     mepolizumab treatment will be eligible to participate in this study. This study will be     conducted in 4 parts in approximately 300 subjects. Part A will be Variable Open-Label Run-in     (for subjects with less than 3 years of mepolizumab treatment). Once the required 3 year     exposure is reached, subjects will enter Part B- Fixed Open-Label Run-In (4 weeks to 8     weeks). During Part A and B subjects will be administered Open-label mepolizumab (100     milligram [mg] Subcutaneous [SC]) every 4 weeks. Part C will be the randomized double-blinded     part. Upon completion of Part B, eligible subjects will be randomized to mepolizumab (100 mg     SC) every 4 weeks or placebo administered SC every 4 weeks for 52 weeks.      Subjects discontinuing investigational product (IP) due to a clinically significant asthma     exacerbation will then enter optional Part D of the study. During Part D, subjects receive     open-label mepolizumab in addition to their standard of care therapy for the remainder of the     study, through Part D up to 52-weeks post-randomization. An Exit Visit will be conducted 52     weeks after randomization in order to assess subject's efficacy parameters, immunogenicity     status, and to conduct additional safety assessments. Eligible subjects will participate in     the study ranging from 56 to192 weeks, depending on the duration of Part A (0 to 132 weeks)     and Part B (4 to 8 weeks).   "
256604|NCT02500797|"     This randomized phase II trial studies how well nivolumab with or without ipilimumab works in     treating patients with sarcoma that has spread from the primary site to other parts of the     body or cannot be removed by surgery. Monoclonal antibodies, such as nivolumab and     ipilimumab, may block tumor growth in different ways by targeting certain cells. It is not     yet known whether nivolumab works better with or without ipilimumab in treating patients with     metastatic or unresectable sarcoma.   "
256595|NCT02551731|"     Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy     that usually strikes children in the first year of life. There is a great need for safe and     effective therapies in the treatment of IS. This need is even more important for infants and     toddlers still sick after being treated with medicine that is already available.      This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution     (COS) in the treatment of children aged 6 months through 36 months with a diagnosis of     infantile spasms who have not responded to first line therapies.      The overall study duration is expected to be 64 weeks for those subjects who respond to COS     treatment. The maximum possible study duration for each patient is approximately 64 weeks,     however a subject will be deemed to have completed the study after 58 weeks.   "
256596|NCT02564744|"     This is an open label, multicenter, non-randomized phase 2 (with safety run-in phase)     clinical study. The study will consist of a screening period, a treatment period, an end of     treatment visit, and a follow-up period.   "
256597|NCT02548494|"     The management goals of diabetic ketoacidosis (DKA) in the pediatric type 1 diabetes (T1DM)     population are fluid and electrolyte repletion, insulin administration, and correction of     acidosis in order to stabilize the patient. Traditionally, a rapid-acting insulin IV infusion     is begun immediately and continued until the acidosis is corrected and hyperglycemia     normalized. Once the acidosis is corrected, patients are able to be transitioned to a     subcutaneous insulin regimen.      The role that a subcutaneous long-acting insulin such as glargine has in the acute treatment     of DKA has not been extensively studied. While giving glargine during the treatment of DKA is     becoming more common place, few studies have examined the potential risks and benefits of its     use. This study will investigate the effects of early administration of glargine during DKA     in patients with newly diagnosed TIDM.      The design of this study is a prospective, double-blind study of children ages 2-21 who are     admitted to the hospital in DKA with a diagnosis of T1DM. The control group will receive all     traditional methods of treatment for DKA, including a placebo subcutaneous injection. The     study group will receive the same treatment, but will be supplemented with a subcutaneous     glargine injection.   "
256598|NCT02545842|"     Primary Objective:      To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients     using insulin glargine which can provide the highest control rate of glycated hemoglobin     (HbA1c) < 7%.      Secondary Objectives:      The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c <7.0% in patients     achieving their FPG target. The percentage of HbA1c <7% without hypoglycemia. The percentage     of patients achieving the FPG target without hypoglycemia. The percentage of patients     achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast <10     mmol/L).   "
256599|NCT02531113|"     The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.   "
256600|NCT02519218|"     The purpose of this study is to collect outcomes data in patients implanted with the Ellipse     IM HTO Nail System.   "
256601|NCT02835391|"     This study is a post market, multi-centre, randomised study evaluating PerClot compared to     usual care. PerClot is a CE marked device and is currently used as a haemostat in     gynaecological surgery throughout Europe. The purpose of this study is to collect additional     post market data on its use in this indication.   "
256602|NCT02506153|"     This randomized phase III trial studies how well high-dose recombinant interferon alfa-2B or     ipilimumab works compared with pembrolizumab in treating patients with stage III-IV melanoma     that has been removed by surgery but is likely to come back or spread. High-dose recombinant     interferon alfa-2B may help shrink or slow the growth of melanoma. Monoclonal antibodies,     such as ipilimumab and pembrolizumab, may block tumor growth in different ways by targeting     certain cells. It is not yet known whether high-dose recombinant interferon alfa-2B or     ipilimumab is more effective than pembrolizumab in treating patients with melanoma.   "
256620|NCT02438618|"     The objective of this study is to make a comparison between two surgical techniques used when     implanting a Ponto bone anchored hearing system.   "
256621|NCT02416622|"     This study will evaluate the safety and efficacy of a recombinant adeno-associated virus     vector expressing retinoschisin (rAAV2tYF-CB-hRS1) in patients with X-linked retinoschisis.     Up to 27 participants will be enrolled and 3 dose levels will be evaluated in a dose     escalation format.   "
256622|NCT02412163|"     This study further evaluates the safety profile and efficacy of the Ellipse IM HTO Nail     system in subjects with osteoarthritis and varus malalignment of the knee. All subjects will     receive treatment with the Ellipse IM HTO Nail System and followed for six months.   "
256603|NCT02502838|"     Pelvic organ prolapse (POP) is a common condition in women. Approximately 20% of women     undergo surgical correction for POP in their lifetime. Overactive bladder symptoms (OAB) are     often associated with POP in 25-69% of patients and POP has been shown to be an independent     risk factor for OAB. There is scientific evidence that surgical repair of POP reduces or     eliminates OAB in >85%. In addition, stress urinary incontinence (SUI) is also often     associated with POP, either clinically evident or as a potential post-operative complication.      The clinical decision as to include a surgical technique to treat SUI when repairing POP     surgically is still a matter of controversy. Most surgeons at the institution will include an     extra procedure, specifically a retropubic sling, if SUI is clinically evident. Some will not     include it unless there is urodynamic or clinical evidence of potential SUI post-operatively.     Finally, some will include it regardless of clinical or urodynamic findings based on the     apparent high incidence of such SUI after prolapse repair. The Tension-Free-Vaginal Tape     (TVT) has been observed to reduce OAB as well as produce de-novo OAB symptoms, so the effect     of TVT on OAB is still unclear.      The purpose of this study is to determine the effect of additional TVT surgery on OAB     symptoms in patients undergoing POP repair. It is hoped that such data will better determine     the effect of either surgical intervention strategy on OAB symptoms. This is a prospective     cohort study comparing patients with OAB that undergo surgical repair of their prolapse with     or without additional TVT surgery. The outcomes will be measured using pre- and     post-operative validated questionnaires (PFDI-20, OAB-q short form).   "
256605|NCT02500381|"     The main objective of this study is to evaluate the efficacy of SRP-4045 and SRP-4053     compared to placebo in Duchenne muscular dystrophy (DMD) patients with out-of-frame deletion     mutations amenable to skipping exon 45 and exon 53 respectively. Additional objectives     include evaluation of safety, pharmacokinetics and biomarkers.   "
256606|NCT02617446|"     To Assess the safety, tolerability and efficacy of two different doses of istaroxime (0.5 and     1.0 µg/kg/min), a new agent with lusitropic and inotropic activities that improves the     cardiac contraction-relaxation cycle. The 2 doses of istaroxime (0.5 and 1.0 µg/kg/min) will     be infused i. v. for 24 hours in comparison with placebo, in treatment of Chinese and Italian     patients with Acute Decompensated Heart Failure. In all the Italian patients and in a subset     of Chinese patients pharmacokinetics and metabolism of istaroxime shall also be studied.   "
256607|NCT02545296|"     HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care     tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya,     Tanzania.   "
256608|NCT02487953|"     The purpose of this research study is to determine whether combining electronic nicotine     delivery systems (ENDS) with nicotine patch treatment will augment abstinence rates compared     to either treatment alone.   "
256609|NCT02484443|"     This phase II trial studies how well dinutuximab works when given with sargramostim in     treating patients with osteosarcoma that has come back after treatment (recurrent).     Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them.     Sargramostim may help the body increase the amount of white blood cells it produces, which     help the body fight off infections. Giving dinutuximab with sargramostim may work better and     kill more cancer cells.   "
256610|NCT02468648|"     Background:      - Chronic hepatitis C is a serious liver disease. Current treatments have side effects. New     drugs have been developed, but they work better in some people than others. Researchers want     to learn why.      Objective:      - To learn why new hepatitis C drugs sometimes don t work. Also, to learn if these drugs are     safe and how well they work in people with different virus strains.      Eligibility:      - Adults age 18 and older who are infected with hepatitis C virus genotypes 1-4 and who have     either never been treated or treated previously with an interferon regimen (with or without     ribavirin) that failed to clear the virus.      Design:        -  Participants will be screened with medical history and physical exam. They will have          blood and urine tests and complete questionnaires.        -  Participants will have a Fibroscan an ultrasound that measures liver stiffness and other          liver scans. They will have an electrocardiogram.        -  Eligible participants will have a liver biopsy.        -  Participants will be admitted to the Clinical Center. They will have a physical exam and          blood tests, and complete questionnaires.        -  They will take the first study drug dose as a tablet taken once daily.        -  Participants will take the drug at home for 12 weeks.        -  Participants will have 6 study visits. They will have blood and vital signs taken, and          complete questionnaires.        -  At week 4, participants will have another liver biopsy.        -  After their last drug dose, participants will have 5 follow-up visits. They will have          blood and vital signs taken, and complete questionnaires. They will discuss their          medications and side effects. They may have another Fibroscan.   "
256611|NCT02465060|"     This phase II trial studies how well treatment that is directed by genetic testing works in     patients with solid tumors or lymphomas that have progressed following at least one line of     standard treatment or for which no agreed upon treatment approach exists. Genetic tests look     at the unique genetic material (genes) of patients' tumor cells. Patients with genetic     abnormalities (such as mutations, amplifications, or translocations) may benefit more from     treatment which targets their tumor's particular genetic abnormality. Identifying these     genetic abnormalities first may help doctors plan better treatment for patients with solid     tumors, lymphomas, or multiple myeloma.   "
256612|NCT02467920|"     Efficacy and Safety of Basal Insulin Glargine Combination with Exenatide bid vs Switching     Premix Human Insulin to Aspart30 in T2DM with Inadequate Glycaemic Control on Premixed Human     Insulin and Metformin: a Randomized, Open, Parallel trial.   "
256613|NCT02458833|"     This study aims to test the effectiveness of a community-based, peer-mentored intervention to     improve home food preparation practices in families with young children.   "
256614|NCT02449317|"     Bioelectrical impedance analysis guided volume expansion for the prevention of contrast     induced-acute kidney injury   "
256623|NCT02413788|"     Inflammatory markers have been analyzed in several diseases of unknown etiology, in the     expectation of increasing therapeutic perspectives. This possibility arises from the     different levels of tissue injury with low-grade chronic inflammation that have been observed     in studies in which the markers were not evaluated traditionally, and today have influenced     clinical management.      The investigators aimed, therefore, to evaluate the inflammatory markers in patients with AIS     before and after aerobic and combined exercise training.   "
256624|NCT02408549|"     Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy     for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects >= 4 years of     age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM     SP0982 (NCT02408523) study.   "
256625|NCT02408523|"     Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on     Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age with     idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration     of study drug administration is 28 weeks. Eligible subjects may choose to enter the     open-label extension study after completion.   "
256626|NCT02422264|"     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'     Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women     who participated in study 116945 [DTPA (BOOSTRIX)-047]. This study will help us evaluate if     the presence of transplacentally transferred maternal antibodies interfere with the immune     response to primary vaccination with Infanrix hexa and a co-administered pneumococcal     conjugate vaccine given as a part of this study in infants.   "
256627|NCT02388048|"     A clinical study to evaluate a treatment with two drugs, named Ofatumumab and Ibrutinib, in     patients with lymphoblastic acute leukemia who have been already treated with other     therapies.   "
256628|NCT02385669|"     This study evaluates whether it is safe to administer a peptide vaccine with ipilimumab. This     study will also evaluate the effects of the combination of the peptide vaccine and ipilimumab     on the immune system. The investigators will monitor these effects by performing tests in the     laboratory on participants' blood, a lymph node, and tumor samples.   "
256629|NCT02382107|"     The diagnosis of tuberculosis (TB) and especially the detection of drug resistance of     tuberculosis mycobacteria can be time consuming and costly. New and rapid diagnostic tests     are needed to improve early case detection and correct initiation of treatment.      In the planned cross-sectional diagnostic evaluation study the investigators are aiming for     the assessment of several new TB diagnostics (e.g. new AID strip assays and TrDNA assay in     urine) in TB suspects who are presenting themselves to the pulmonary ambulance (TB dispensary     for sector 4) at the Marius Nasta Institute (MNI). The study will be conducted in a     co-operation between the MNI and the German Center for Infection Research (DZIF).   "
256630|NCT02392559|"     A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged     10-17 years diagnosed with heterozygous familial hypercholesterolemia.   "
256631|NCT02367196|"     CC-90002-ST -001 is an open-label, Phase 1, dose escalation and expansion clinical study in     subjects advanced, refractory solid and hematologic cancers.   "
256632|NCT02359994|"     This is a prospective, multicenter, multidisciplinary, controlled clinical investigation     evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared     to a similar marketed hemostatic device.      Three hundred and twenty four subjects across a maximum of 25 investigational sites     undergoing open elective cardiac, general, or urological surgical procedures who meet the     eligibility criteria will be intraoperatively randomized to receive no more than the entire     contents of up to two 5 gram bellows of either the investigational device or a control     hemostatic agent on a bleeding site, whose anatomic site is smaller than or equal to 25cm²     and whose anatomic application site is smaller than or equal to 47cm², when bleeding is     within the pre-defined bleeding severity range after any applicable conventional means for     hemostasis are attempted as specified in the intraoperative procedures.      Each investigational site is expected to enroll approximately 13-40 subjects. All     investigational sites will be located in the U.S. Follow-up will occur at hospital discharge     and 6 weeks post-device application. For oncologic subjects, an additional follow up will     occur at 24 months post device application.   "
256633|NCT02348437|"     The purpose of this study is to determine the functional outcome of repairing the pronator     quadratus (PQ) muscle in subjects operated for a distal radius fracture (DRF) with volar     locked plating.   "
256634|NCT02343354|"     Women with gestational diabetes (GDM) have increased risk of developing type 2 diabetes;     their children show more insulin resistance and diabetes compared to offspring of mother     without diabetes in pregnancy. An increased diabetes risk is also observed among partner of     adult with prediabetes/type 2 diabetes. The investigators have pilot-tested a program for     diabetes risk reduction among women within 5 years of a GDM pregnancy (MoMM program). The     investigators are now enhancing the program to engage directly the partner (MoMMii program).      In MoMMii, 66 couples with a history GDM in the mother will participate in a multimodal     diabetes prevention program that includes healthy meal preparation training, discussion of     eating and physical activity behaviours and developing home environments that facilitate     healthy habits, pedometer-based step count monitoring, and participation in family-based     activities (frisbee, soccer) as well as individual exercise (e.g., use of exercise equipment,     floor resistance exercises). Participants will be encouraged to communicate between sessions     with study personnel and with one another to create a between family support network. All     mothers and fathers will participate in five sessions over six months. The investigators will     examine changes in health-related behaviours, blood pressure, glucose levels, and insulin     sensitivity/resistance in both mothers and fathers.   "
256635|NCT02342808|"     This study will examine the effects of lifestyle intervention on fitness, dietary habits, and     body weight in patients with resistant hypertension (RH). Patients will be randomized to     either a 4-month adjunctive lifestyle intervention designed to lower BP that will be     delivered in a center-based CR program (C-LIFE), or to standardized education and physician     advice (SEPA) designed to promote the same healthy behaviors and reflecting the current     highest possible standard of care for promoting a healthy lifestyle in RH.   "
256657|NCT02281084|"     Evaluate the safety and efficacy of CC-486 and Durvalumab in Subjects with Myelodysplastic     Syndromes who failed to achieve an objective response post iHMA treatment   "
256636|NCT02339571|"     This randomized phase II/III trial studies the side effects and best dose of nivolumab and     ipilimumab when given together with or without sargramostim and to see how well they work in     treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal     antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to     the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific     tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as     sargramostim, may increase the production of white blood cells. It is not yet known whether     nivolumab and ipilimumab are more effective with or without sargramostim in treating patients     with melanoma.   "
256637|NCT02337244|"     The primary objective of this study is to obtain implant survivorship and clinical outcomes     data for commercially available Persona knee implants used in primary total knee     arthroplasty. The assessment will include:        1. Implant survivorship based on removal of a study device.        2. Safety based on incidence and frequency of adverse events.        3. Clinical performance measured by overall pain and function, quality of life data,          radiographic parameters and survivorship.   "
256638|NCT02335996|"     Identifying hypercortisolism patients at risk for cardio-vascular events despite biological     cure, and determine which patients should be particularly followed. Hypercortisolic patients     represent an ideal in vivo model to determine the interactions between glucocorticoids and     ectopic fat development.   "
256648|NCT02306161|"     This randomized phase III trial studies how well combination chemotherapy with or without     ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to     other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in     different ways by targeting certain cells. Drugs used in chemotherapy, such as vincristine     sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. It is not yet known whether     combination chemotherapy is more effective with or without ganitumab in treating patients     with newly diagnosed Ewing sarcoma.   "
256639|NCT02330744|"     The purpose of this study is to test the effects of a computerized approach/avoidance     training (AAT) procedure on behavioral, affective, and brain mechanisms that are important     for reward sensitivity and well-being in individuals diagnosed with major depression. The     training procedure is designed to modify automatic approach responses for positive social     stimuli. The primary aim is to determine the effects of approach/avoidance training on the     functioning of brain systems during reward processing in individuals diagnosed with major     depression. A secondary aim will determine whether brain activation patterns following     approach/avoidance training predict subsequent affective and behavioral responses during     reward processing. An exploratory aim will test whether completing the approach/avoidance     training procedure in combination with a brief computer-delivered behavioral activation     program for depression will produce larger changes in depression symptoms, positive emotions,     and social relationship functioning from pre- to post-intervention compared to the control     training procedure.   "
256640|NCT02321878|"     This trial is conducted in Asia. The aim of this trial is to evaluate safety and     effectiveness of Victoza® in patients with type 2 diabetes mellitus (T2DM) in combination     with antidiabetes agents other than sulfonylurea under post-marketing normal clinical     practice conditions.   "
256641|NCT02336672|"     In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various     modalities as a way to decrease size and downstage the tumour leading to a re-sectable     disease. The HybridTherm probe (HTP), (ERBE Elektromedizin GmbH, Tübingen, Germany) com-bines     bipolar RF-ablation with cryogenic induced cooling. It is well known that a bipolar     radiofrequency system creates ablation with less collateral thermal damage than standard     monopolar systems but with the trade-off to lose overall efficiency.   "
256642|NCT02318602|"     This is a multicenter, open-label trial to assess the long-term safety and efficacy of     Cannabidiol Oral Solution as adjunctive therapy for pediatric and adult participants with     treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet     syndrome (DS). All participants have rolled over from previous trials: INS011-14-029     (NCT02324673), INS011-14-024 (NCT02318537), or INS011- 14-025 (NCT02318563).   "
256643|NCT02318563|"     This Phase 3 study will enroll participants diagnosed with Dravet Syndrome (DS) who are still     experiencing at least one tonic-clonic, clonic, and/or focal seizures with motor components     (FSMC) per week, despite ongoing treatment with up to three antiepileptic drugs (AEDs), and     meet the other inclusion/exclusion criteria.      Following a 28-day baseline period, participants will begin an 84-day treatment period.     Participants will be assigned to receive twice-daily doses of placebo or cannabidiol oral     solution at the highest dose determined to be safe in a previous trial.      Following study completion, all participants will be invited to receive Cannabidiol Oral     Solution in an open label extension study (under a separate protocol).   "
256644|NCT02318537|"     This Phase 3 trial will enroll participants diagnosed with Lennox-Gastaut Syndrome (LGS) who     are still experiencing at least 4 motor seizures involving the trunk or extremities per week,     despite ongoing treatment with up to 3 antiepileptic drugs (AEDs) and who meet     inclusion/exclusion criteria.      Following a 28-day baseline period, participants will begin an 84-day treatment period.     Participants will be assigned to receive twice daily doses of placebo or cannabidiol oral     solution at the highest dose determined to be safe in a previous trial.      Following study completion, all participants will be invited to receive Cannabidiol Oral     Solution in an open label extension study (under a separate protocol).   "
256645|NCT02315430|"     This phase II trial studies how well cabozantinib-s-malate works in treating patients with     ovarian, fallopian tube, or primary peritoneal cavity cancer that has come back or is     growing, spreading, or getting worse. Cabozantinib-s-malate may stop the growth of tumor     cells by blocking the growth of new blood vessels necessary for tumor growth and also by     blocking some of the enzymes needed for cell growth.   "
256646|NCT02311933|"     This randomized phase II trial studies how well tamoxifen citrate works compared with     z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby     tissue or lymph nodes or other parts of the body and has estrogen receptors but not human     epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen can     cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen     hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It     is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in     treating patients with breast cancer.   "
256658|NCT02274883|"     This study is intended to evaluate the nutritive effects of study formulas on growth and     cognitive outcomes.   "
256764|NCT01463306|"     Study A0081106 is a 12-month open-label study to evaluate the long term safety and     tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age     with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with     primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided     daily doses for 1 year, in either capsule or liquid oral formulation.   "
256647|NCT02311790|"     Trans-palmitoleic acid (trans-C16:1) is a naturally occurring trans fatty acid present in     small quantities in foods, most notably in dairy products. Observational evidence suggests a     positive association between trans-C16:1 and insulin sensitivity, and negative association     with risk of developing type 2 diabetes mellitus [1-3]. Cis-palmitoleic acid (cis-C16:1) is     found naturally in foods and is particularly high in macadamia nuts and oil extracted from     the sea buckthorn plant. Animal models suggest that this palmitoleic acid isomer also     improves insulin sensitivity and reduces metabolic dysfunction.      This pilot dosing study is necessary to inform the design of a larger trial to test the     hypothesis that both trans-C16:1 and cis-C16:1 improve insulin resistance but at different     doses. Plasma phospholipid fatty acid profiles will be used as the primary outcome measure.   "
256663|NCT02234128|"     This is a safety study to compare the safety of receiving a lung treated with the Toronto     EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung     transplantation.   "
256664|NCT02232386|"     The present study aims at evaluating whether treatment with two different drugs, Ibrutinib     and Rituximab is both efficient and safe for newly diagnosed patients with chronic     lymphocytic leukemia.   "
256649|NCT02305186|"     The purpose of this clinical trial is to study an experimental drug called pembrolizumab or     MK-3475 for use in combination with chemotherapy and radiation therapy for patients with     resectable (surgical removal) or borderline resectable pancreatic cancer. In general,     pancreatic cancer that cannot be removed by surgery is sometimes treated with chemotherapy     and radiation therapy, called neoadjuvant treatment, to shrink the tumor so that surgery     might be possible. However, this is not always effective at shrinking the tumor enough to     allow it to be removed with surgery. Recent discoveries suggest that the investigators own     immune system might have a role in controlling the growth of tumors. Drugs such as     pembrolizumab can stimulate the immune system against cancer. The purpose of this study is to     investigate whether pembrolizumab can be used safely during neoadjuvant treatment and can     improve the body's immune response against pancreatic cancer.      Pembrolizumab has been approved for treatment of patients with melanoma but has not been     proven to be safe or helpful in patients with pancreatic cancer and is not approved by the     U.S. Food and Drug Administration (FDA) for this purpose.   "
256650|NCT02300545|"     Pazopanib is FDA approved as a second line and beyond treatment for metastatic soft tissue     sarcoma. There is a population of elderly and debilitated soft tissue sarcoma patients that     are not fit for standard first line chemotherapy that is doxorubicin based. As pazopanib is     well tolerated with minimal side effects, the investigators propose a phase II study to     evaluate pazopanib as a first-line agent in patients with non-resectable or metastatic     disease who are not candidates for cytotoxic chemotherapy.   "
256651|NCT02304692|"     This study is designed to compare two different surfaces of bone anchored hearing aid     abutments in terms of bacterial colonization, inflammatory response and skin reactions.   "
256652|NCT02293707|"     GX301 is an experimental therapeutic vaccine directed against human telomerase, an enzyme     playing an essential role in cancer cell proliferation.      This clinical trial will test three different GX301 administration regimens in     castration-resistant prostate cancer patients who have achieved response or disease stability     with first-line docetaxel treatment. This is aimed at identifying an optimal vaccination     regimen.      The three regimens will primarily be compared for their efficacy and safety in inducing     vaccine-specific immunological responses over a period of 6 months following treatment     initiation. In addition, patients will be observed for the occurrence of disease progression     and for their vital status up to 24 months.   "
256653|NCT02289417|"     The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of     apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in subjects with     active Ulcerative Colitis (UC).   "
256654|NCT02432768|"     Background: Patients with the sugar metabolism disorder, Glycogen Storage Disease Type V,     have insufficient breakdown of sugar stored as, glycogen, within the cells. The investigators     know from previous studies with McArdle patients, that they not only have a reduced sugar     metabolism, both also have problems in increasing their fat metabolism during exercise to     fully compensate for the energy deficiency.      Studies on Triheptanoin diet used in patients with other metabolic diseases have shown that     Triheptanoin can increase metabolism of both fat and sugar. In these patients, Triheptanoin     has had a positive effect on the physical performance and has reduces the level of symptoms     experienced by patients.      Aim: To investigate the effect of treatment with the dietary oil, Triheptanoin, in patients     with McArdle disease on exercise capacity.      Methods: 20-30 adult patients will be recruited through Rigshospitalet in Copenhagen,     Denmark, Hopital Pitié-Sapêtrière in Paris, France and through The University of Texas     Southwestern Medical Center in Dallas, Texas.        1. Pre-experimental testing (1 day):           Baseline blood samples are collected to obtain baseline values of safety parameters:          Plasma-acylcarnitines, free fatty acids and creatine kinase.           Subjects perform a max-test to determine their VO2max        2. Treatment period #1 (2 weeks):           Subjects follow a diet consuming a dietary treatment oil. Neither patients nor members          of the study group know who receive which type of oil.        3. Washout period (1 week):           Subjects receive no treatment        4. Treatment period #2 (2 weeks):      Subjects who received Triheptanoin oil in the first treatment period, now receive placebo oil     and vice versa.      Assessments: Before and after each treatment periods, subjects perform a 30-minutes exercise     test on a cycle ergometer, comprising of 20-22 minutes of constant load exercise and 6-8     minutes increasing load to peak. Subjects will complete a Fatigue Severity Scale     questionnaire and metabolic products will be measured in blood and urine.   "
256655|NCT02290496|"     This study is a randomized controlled trial that tests the effectiveness of cognitive     behavior therapy (CBT) for insomnia with comorbid depression in youth aged 12 through 19 who     have recently begun selective serotonin re-uptake inhibitor (SSRI) antidepressants. CBT is     compared with a control condition of sleep hygiene education.   "
256656|NCT02277990|"     Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection     Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded,     post-market, interventional clinical study. This study will evaluate the ability of the TYRX     envelope to reduce major CIED infections through 12-months post-procedure following CIED     generator replacement, upgrade, revision, or de novo CRT-D implant. Additionally, this large     device study provides the unique opportunity to prospectively characterize the performance of     Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous RV     defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those     geographies requiring a post-approval study of the TYRX envelope.   "
256659|NCT02275715|"     The primary aim of the project is to develop and pilot a manualized, individually delivered     Parent Training Program for Feeding Problems (PT-F) in children with autism spectrum disorder     (ASD) to assess feasibility and parent acceptance of the program. The secondary aim of the     project is to assess the success of the PT-F program in improving mealtime behavior problems     when compared to the wait-list control.      Exploratory aims include obtaining preliminary data on the impact of PT-F on child and parent     functioning (reducing parent stress and improving parent sense of competency and parent-child     interactions at mealtime), assessing the impact of treatment on interfering behaviors around     mealtime/snack times, and measuring nutritional improvements after treatment.   "
256660|NCT02274129|"     This study investigates the use of a new healing cap which, through altered design and choice     of material, has been improved when it comes to minimizing the risk of it falling off as well     as increasing patient comfort.   "
256661|NCT02244632|"     The purpose is to characterise the tolerability of Modufolin in combination with 5-FU alone,     in combination with 5-FU and Oxaliplatin, in combination with 5-FU and Irinotecan and in     combination with 5-FU, Oxaliplatin and Bevacizumab.      Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further     assessment.   "
256662|NCT02240433|"     The main purpose of this study is to evaluate safety and tolerability of LY2157299 when     combined with sorafenib in Japanese hepatocellular carcinoma (HCC) participants.   "
256665|NCT02224781|"     This randomized phase III trial studies how well initial treatment with ipilimumab and     nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment     with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with     stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by     surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells.     Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not     yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and     trametinib is more effective than treatment with dabrafenib and trametinib followed by     ipilimumab and nivolumab.   "
256666|NCT02216214|"     The purpose of this study is to assess the efficacy, safety and tolerability of mirabegron     versus placebo in the treatment of older adult subjects with OAB.   "
256667|NCT02234050|"     The aim of this study is to collect data on activity, toxicity and quality of life of     trabectedin therapy in patients with recurrent high-grade meningioma.   "
256668|NCT02208531|"     We hypothesize that it is feasible to integrate a program of Nutritional Care and Pychosocial     Stimulation into the Community Clinics in Bangladesh and thereby improve malnourished     children's growth and development after a year of intervention.   "
256669|NCT02201485|"     Budd-Chiari syndrome (BCS) is defined as the hepatic outflow obstruction from the small     hepatic veins to the confluence between inferior vena cava and right atrium, which often     leads to the life-threatening complications, such as liver failure and portal     hypertension-related complications. At present, a stepwise treatment strategy is employed,     including anticoagulation, thrombolysis, percutaneous recanalization (i.e., percutaneous     transluminal angioplasty [PTA] alone or in combination with stent placement), transjugular     intrahepatic portosystemic shunt, and liver transplantation. In West, only less than 20% of     BCS patients underwent percutaneous recanalization; by contrast, percutaneous recanalization     is the most common treatment modality used in China.      Recently, an 11-year retrospective case series of 177 Chinese patients with primary BCS has     shown a higher rate of re-occlusion in the PTA alone group than in the PTA combined with     stent placement group (31% versus 7.7%, p<0.001). In addition, re-occlusion was regarded as     the independent predictor of mortality. Accordingly, we hypothesized that PTA alone might     have a worse survival than PTA combined with stent placement in Chinese patients with primary     BCS.   "
256670|NCT02200614|"     The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in     patients with non-metastatic castration-resistant prostate cancer.   "
256671|NCT02196623|"     Ageing is the primary risk factor for most chronic diseases including type 2 diabetes     mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial mechanisms     leading to decreased exercise tolerance and worsened insulin sensitivity. Thus, metabolic     disease and frailty, which limits physical mobility as well as quality of life, share common     cellular mechanisms.      The investigators will test the hypothesis that a combination of normobaric hypoxia and     exercise training elicits a synergistic effect on age-associated metabolic skeletal muscle     dysfunction and the investigators will address the molecular mechanisms. In a randomized     clinical study, the investigators will compare normoxic and hypoxic training conditions in     elderly subjects. Outcome measures will focus on whole body insulin sensitivity and     mitochondrial responses in skeletal muscle before and after the 8-week training intervention.   "
256672|NCT02196181|"     This randomized phase II trial studies how well dabrafenib and trametinib work in treating     patients with stage III-IV melanoma that cannot be removed by surgery and contains a B-Raf     proto-oncogene, serine/threonine kinase (BRAF) mutation. Dabrafenib and trametinib may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
256673|NCT02194738|"     This research trial studies genetic testing in screening patients with stage IB-IIIA     non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in     a patient?s tumor cells may help doctors select the best treatment for patients that have     certain genetic changes.   "
256674|NCT02193282|"     This randomized phase III trial studies how well erlotinib hydrochloride compared to     observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has     been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
256675|NCT02189278|"     Evidence-based guidelines recommend cancer surveillance procedures for breast cancer     survivors including physical examination, mammography, breast self-exam, and gynecologic     follow-up. The early detection of recurrent and new cancers can best be achieved through the     combined, on schedule use of these surveillance procedures. Yet, data suggest that up to 55%     of breast cancer survivors do not undergo these procedures as recommended. This study tests a     telephone-based psychosocial intervention aimed at improving adherence to recommended     surveillance in breast cancer survivors. The psychosocial intervention for improving     adherence is compared to treatment as usual.   "
256676|NCT02185781|"     The present study aims at studying how safe and tolerable a new therapy for patients with     Acute Lymphoblastic Leukemia (ALL) is.      This new therapy consists of an immunotherapy, that is an approach focusing on the immune     system, and it targets ALL patients in complete remission but who may still have the disease     at a cellular level (this is called 'minimal residual disease').      For any further information, please, discuss with your treating physician.   "
256677|NCT02184611|"     Studies to date provides substantial evidence for the effectiveness for UMEC 62.5 microgram     (mcg) as a long term maintenance therapy for the treatment of COPD; this study further     evaluates the efficacy and safety of UMEC 62.5 mcg administered once-daily (OD) for 24 weeks     via a NDPI compared with placebo in Asian subjects with COPD. Over approximate 27 weeks of     entire study duration, 10 study clinic visits will be conducted on an outpatient basis.     Pre-screening visit will be conducted for the informed consent form, review demography, COPD     history and COPD concomitant medications. Subjects meeting the eligibility criteria at     screening will complete a 7 to 14 day Run-in period and will be provided with     albuterol/salbutamol as rescue medication on an as-needed basis. Further, subjects will be     randomized to the UMEC 62.5 mcg or matching placebo in a 1:2 ratio for 24 week treatment     period. A follow up for adverse event assessment will be scheduled approximately 7 days after     the treatment period or the Early Withdrawal Visit.   "
256679|NCT02169271|"     This randomized phase II trial studies acetylsalicylic acid compared to placebo in treating     high-risk patients with subsolid lung nodules. A nodule is a growth or lump that may be     malignant (cancer) or benign (not cancer). Chemoprevention is the use of drugs to keep cancer     from forming or coming back. The use of acetylsalicylic acid may keep cancer from forming in     patients with subsolid lung nodules.   "
256680|NCT02157064|"     The purpose of this study is to determine the impact that treatment with a cellular     concentrate derived from an individual's own fat, known as the stromal vascular fraction     (SVF), has on the quality of life of people with multiple sclerosis (MS). SVF contains     components with regenerative properties, including stem cells that may be capable of     ameliorating specific disease conditions. This study is designed to evaluate quality of life     changes in individuals with MS for up to 12 months following SVF treatment.   "
256681|NCT02155660|"     The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in     symptomatic patients with moderate to very severe COPD who are receiving standard of care     therapies.   "
256682|NCT02163694|"     The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination     with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced,     unresectable, BRCA-associated breast cancer.   "
256683|NCT02147938|"     Assessment in a real situation of the conversion conditions, the efficacy and the safety of     the treatment with tacrolimus in renal transplant patients converted from the tacrolimus     twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up     at one year.      Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early     (during the first 6 months post-transplantation) or late (between 6 and 12 months     post-transplantation).   "
256684|NCT02138409|"     Participants will be selected from patients who have been scheduled at the site for treatment     of chronic pain without sedation. They will receive either fentanyl sublingual spray or a     matching placebo sublingual spray that delivers no medication.      Participants may take pain killers at any time after the procedure for pain relief. They will     be given a diary card, which they will take home. They will record the name of the medication     taken, the time, and dosage.      The study coordinator will call participants about 24 hours after the procedure to collect     information from the diary card and follow up information about pain and side effects     (adverse events) after they left the site.   "
256685|NCT02143479|"     A study in which two groups of patients will be analysed; patients converted from Prograf to     Advagraf within the first 3 months after transplantation and patients converted from Prograf     to Advagraf between 3 months and 1 year after transplantation.   "
256686|NCT02135692|"     This is a multi-center, open-label, long-term study of subcutaneously (SC) administered     mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic     asthma. This study will enroll a subset of subjects from Study MEA115661 who have     demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy     are individuals at greatest risk of serious deterioration of their health status. In order to     target individuals at greatest risk for serious deterioration of their health status, only     subjects from the MEA115661 study with a history of life-threatening or seriously     debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility     criteria for the study will be offered the opportunity to consent for this study of up to 128     weeks in length (including the Follow-Up Visit). This study will give opportunity to extend     the collection of clinical data for long-term use and further assess the sustainability of     efficacy in a population likely to experience significant loss of asthma control and the need     for higher doses of systemic steroids if returned to SOC only.   "
256765|NCT01452646|"     The purpose of this study is to determine whether a risk-adapted, minimal-residual-disease     directed therapy for young adults with newly diagnosed acute myeloid leukemia has positive     results in terms of overall survival at 24 months.   "
256687|NCT02136212|"     The purpose of this study is to test the effects of a computerized approach/avoidance     training (AAT) procedure in a sample of individuals diagnosed with social anxiety disorder     (SAD). The training procedure is designed to modify automatic approach responses for positive     social stimuli. Previous research has shown that a single administration of approach-positive     AAT influences social behavior in the laboratory. The goal of this study is to examine the     effects of a four-session AAT procedure on measures of positive social-emotional functioning.     The investigators hypothesize that individuals assigned to the approach-positive AAT     condition will demonstrate larger increases in positive affect and improvements in social     relationship functioning from pre- to post-assessment compared to those assigned to the     control condition.   "
256688|NCT02124772|"     This is a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label,     study in pediatric subjects with refractory or recurrent tumors. Part A is a repeat dose,     dose escalation monotherapy study that will identify the recommended phase II dose (RP2D) on     the continuous dosing schedule using a 3 + 3 dose- escalation procedure. Part B will evaluate     the preliminary activity of trametinib monotherapy in 4 disease-specific cohorts of subjects.     Each cohort will enroll at least 10 response-evaluable subjects (evaluable for response is     defined as a subject with a pre-dose and at least 1 post-dose disease assessment or clinical     assessment of progression of disease). Part C is will be a 3+3 study design to determine the     safety, tolerability and preliminary activity of the RP2D of trametinib in combination with a     limited dose escalation of dabrafenib. Part C will enroll up to 24 subjects. Part D will     evaluate the preliminary activity of trametinib in combination with dabrafenib in 2     disease-specific cohorts of subjects diagnosed with LGG and LCH. LGG cohort will enroll     approximately 20 response-evaluable subjects and the LCH cohort will enroll approximately 10     response-evaluable subjects. The overall goal of this trial is to efficiently establish safe,     pharmacologically relevant dose of trametinib monotherapy and trametinib in combination with     dabrafenib in infants, children and adolescents and determine preliminary activity of     trametinib monotherapy and trametinib in combination with dabrafenib in selected recurrent,     refractory or unresectable childhood tumors.   "
256689|NCT02126579|"     The purpose of this study is to learn what effects (good and bad) an experimental vaccine     (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide     ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine     and these drugs cause any changes in your immune system.   "
256690|NCT02112916|"     This randomized phase III trial compares how well combination chemotherapy works when given     with or without bortezomib in treating patients with newly diagnosed T-cell acute     lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help     reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for     cell growth. It may also help chemotherapy work better by making cancer cells more sensitive     to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib     is more effective in treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic     lymphoma.   "
256691|NCT02101853|"     This randomized phase III trial studies how well blinatumomab works compared with standard     combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that     has returned after a period of improvement (relapsed). Monoclonal antibodies, such as     blinatumomab, may interfere with the ability of tumor cells to grow and spread. It is not yet     known whether standard combination chemotherapy is more effective than blinatumomab in     treating relapsed B-cell acute lymphoblastic leukemia.   "
256692|NCT02101788|"     This randomized phase II/III trial studies how well trametinib works and compares it to     standard treatment with either letrozole, tamoxifen citrate, paclitaxel, pegylated liposomal     doxorubicin hydrochloride, or topotecan hydrochloride in treating patients with low-grade     ovarian cancer or peritoneal cavity cancer that has come back, become worse, or spread to     other parts of the body. Trametinib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. It is not yet known whether trametinib is more effective     than standard therapy in treating patients with ovarian or peritoneal cavity cancer.   "
256693|NCT02099721|"     The purpose of this study is to demonstrate that primary prevention patients with one or more     additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained     ventricular tachycardia (NSVT), frequent pre-ventricular contractions (PVCs), and low left     ventricular ejection fraction (LVEF)) are at a similar risk of life-threatening ventricular     arrhythmias (LTVA) when compared to secondary prevention patients, and would receive similar     benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization     therapy- defibrillator (CRT-D) implant.   "
256694|NCT02091960|"     The purpose of this study is to evaluate the efficacy of enzalutamide with trastuzumab in     subjects with HER2+ AR+ metastatic or locally advanced breast cancer.   "
256695|NCT02067143|"     This study will be conducted in different centres and will study adult patients with     Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL). The study     treatment will include a induction/consolidation therapy incorporating pegylated Asparaginase     (Peg-ASP) and lineage-targeted high-dose methotrexate plus other antileukemic drugs, for the     achievement of an early negative minimal residual disease (MRD) status. The MRD study     supports a risk/MRD-oriented final consolidation phase.   "
256696|NCT02066181|"     This randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate     in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may     stop the growth of tumor cells by blocking some of the proteins needed for cell growth.     [Funding Source - FDA OOPD]   "
256715|NCT01948570|"     Primary end point of the study is the clinical and non-invasive instrumental evaluation of     the activity of P-3075 cream on subjects with acne: 20 subjects with a mild/moderate grade     and 20 subjects with a moderately severe/severe grade, according to Cunliffe' classification.      Secondary end-points are the cosmetic acceptability and efficacy evaluation by the volunteers     and the local tolerability assessed by the investigator and the subjects.   "
256780|NCT01290900|"     This is a single dose study in healthy male volunteers to investigate the effect of high     doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT     interval   "
256781|NCT01304836|"     The purpose of this study is to focus on potential differences in the occurrence of new-onset     Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of     immunosuppressive treatment are compared.   "
256697|NCT02064478|"     A bone anchored hearing system is used to improve hearing for patients with e.g.     conductive/mixed hearing loss or single sided deafness.      With this type of system, a titanium implant is installed in the temporal bone, where it     osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to     the implants and penetrates the skin. The sound processor (hearing aid) is then connected to     the abutment, and can be attached and removed by the patient via a snap-coupling. This type     of system has been successfully implanted in more than 100.000 patients. Recently, a     simplified surgical procedure, where no skin thinning around the abutment is made, was     approved. The results after using this installation technique, here called soft tissue     preservation, are the focus of this study.      The objective of the study is to compare the outcomes after a surgical procedure with soft     tissue preservation (test) and a surgery with soft tissue reduction (control) for placing     Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness     around the implant is less in the test group compared to the control group.   "
256698|NCT02048813|"     This randomized phase III trial studies ibrutinib and rituximab to see how well they work     compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with     untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Monoclonal antibodies, such as rituximab, interfere with     the ability of cancer cells to grow and spread. It is not yet known whether fludarabine     phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in     treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.   "
256737|NCT01761890|"     The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored,     prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with     dasatinib. Patients will be followed for 5 years. This study will help the definition of     guidelines for the treatment of CML patients in early phases.      The primary objective of the study is to describe, in the clinical practice, the rate of     events leading to permanent discontinuation after 2 years of treatment with dasatinib as     frontline therapy in newly diagnosed CML patients.   "
256699|NCT02021604|"     Low blood sugars are known to cause brain damage in newborn babies. One of the most common     causes of low blood sugars persisting beyond the new born period is a condition called     congenital hyperinsulinism (HI). This is a disease whereby the pancreas secretes too much     insulin and causes low blood sugars. Twenty to forty percent of these babies will have brain     damage. There are two forms of this disease. In one form only a small part of the pancreas     makes too much insulin (focal HI) and in the other, the whole pancreas make too much insulin     (diffuse HI). If a surgeon could know which part of the pancreas has the focal lesion he     could remove it and cure the patient.      The purpose of this study is to investigate whether a new investigational drug called     Fluorodopa F 18, when used with a PET scan, can find the focal lesion and guide the surgeon     to remove it, thus curing the patient and preventing further brain damage   "
256700|NCT02039947|"     This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and     Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma     that has metastasized to the brain. This study will evaluate the safety and efficacy of 4     cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain,     symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without     prior local (brain) therapy, and range of ECOG scores from 0-2.   "
256701|NCT02016456|"     This research programme purports to test the effectiveness of two Transcranial Magnetic     Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in     reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI)     scans to improve the localization of TMS targets.   "
256702|NCT02014129|"     The main purpose of this study is to evaluate safety and side effects of LY2835219 in     Japanese participants with advanced cancer.   "
256703|NCT02034110|"     This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in     combination with oral Trametinib in subjects with rare cancers including anaplastic thyroid     cancer, biliary tract cancer, gastrointestinal stromal tumor, non-seminomatous germ cell     tumor/non-geminomatous germ cell tumor, hairy cell leukemia, World Health Organization (WHO)     Grade 1 or 2 glioma, WHO Grade 3 or 4 (high-grade) glioma, multiple myeloma, and     adenocarcinoma of the small intestine, with BRAF V600E positive-mutations. This study is     designed to determine the overall response rate (ORR) of oral Dabrafenib in combination with     oral Trametinib in subjects with rare BRAF V600E mutated cancers. Subjects will need to have     a fresh or frozen tumor tissue sample provided to confirm the BRAF V600E mutation status.     Only subjects with histologically confirmed advanced disease and no available standard     treatment options will be eligible for enrollment. Subjects will undergo screening     assessments within 14 days (up to 35 days for ophthalmology exam, echocardiogram or disease     assessments) prior to the start of treatment to determine their eligibility for enrollment in     the study.   "
256704|NCT02003222|"     This randomized phase III trial studies combination chemotherapy with blinatumomab to see how     well it works compared to induction chemotherapy alone in treating patients with newly     diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase     (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as     blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not     yet known whether combination chemotherapy is more effective with or without blinatumomab in     treating newly diagnosed acute lymphoblastic leukemia.   "
256723|NCT01870401|"     To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of     stenosis or occlusion of native below-the-knee arteries.   "
256724|NCT01838668|"     This is a multicenter study conducted in 2 parts:      The primary objective in Part I of this study is to determine the efficacy of BG00012     (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion     activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at     Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS)     including participants from the Asia-Pacific region.      The secondary objectives in Part I of this study in this study population are to determine     whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the     cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the     number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24     compared with Baseline.      The primary objective in Part II (open label) of this study is to evaluate the long-term     safety profile of BG00012 in eligible participants from Part I.   "
256705|NCT02003209|"     This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab     with estrogen deprivation to see how they work compared to docetaxel, carboplatin,     trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone     receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer     that is operable or has spread from where it started to nearby tissue or lymph nodes (locally     advanced). Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and     pertuzumab, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving more than     one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth     of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition     therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation     therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and     radiation therapy with or without hormone therapy may be an effective treatment for hormone     receptor-positive, HER2-positive, operable or locally advanced breast cancer.   "
256756|NCT01535391|"     This study is an open-label, multicentric, phase IIIb study of NILOTINIB administered orally     twice daily for 24 months and indefinitely if it is in the interest of the patient.      The primary objective of the trial is to evaluate the efficacy of nilotinib, 300 mg twice     daily with dose increase to 400 mg twice daily in case of suboptimal response or failure     (excluding patients who will fail for progression to ABP), in a population of patients with     Ph-positive, BCR-ABL positive CML in early CP.   "
256757|NCT02145936|"     The purpose of this study is to to determine the effect of habituation to diets with     different types of dietary fat (stearic, palmitic and oleic) on selected Cardiovascular     Disease (CVD) risk indicators with an emphasis on inflammation.   "
256706|NCT01996995|"     In a sham controlled double-blind trial we aim to establish the efficacy and safety of local     application of laser therapy in patients with diabetes with onychomycosis and risk factors     for diabetes related foot complications. Onychomycosis leads to thickened and distorted     nails, which in turn leads to increased local pressure. The combination of onychomycosis and     neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes     related foot complications. Usual care for high-risk patients with diabetes and onychomycosis     is completely symptomatic with frequent skiving and clipping of the nails. No effective     curative local therapies exist and systemic agents are often withheld due to concerns for     side effects and interactions.      Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser application     on the one-year clinical and microbiological cure rate in a randomised, double-blinded     sham-controlled design with blinded outcome assessment.      Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot     ulcers.      Intervention: local laser treatment from a podiatrist and the other group receives treatment     according to a control procedure. The laser procedure will be performed as a sham procedure     by a second podiatrist.      Main study parameters/endpoints: The effect of 4 sessions of laser therapy on cure rate     (clinical and microbiological) after one year.   "
256707|NCT02006017|"     The use of the best evidence available for decision-making is nowadays an undisputed goal in     health care. However, this is not always achieved in the context of clinical practice. Two of     the potential solutions to bridge the gap between evidence and the clinical practice are the     evidence summaries and the evidence based recommendations. However, it is not clear, and     frequently controversial, to what extent clinicians consider helpful recommendations     accompanying evidence summaries. The investigators will explore this question by conducting a     study where clinicians will be randomized to receive a clinical scenario accompanied by an     evidence summary plus a recommendation and a second clinical scenario accompanied by only for     an evidence summary (group A) or vice versa (Group B). The outcome will be clinicians'     preferences.   "
256708|NCT01986829|"     This phase II trial studies how well cryoablation, radiofrequency ablation, or microwave     ablation works in treating patients with metastatic sarcoma stable on chemotherapy.     Cryoablation kills tumor cells by freezing them. Radiofrequency ablation uses a     high-frequency, electric current to kill tumor cells. Microwave ablation kills tumor cells by     heating them to several degrees above body temperature.   "
256709|NCT01979536|"     This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib     and combination chemotherapy works in treating patients with newly diagnosed stage II-IV     anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab     vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib and     methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. It is not yet known whether brentuximab vedotin and combination chemotherapy is     more effective than crizotinib and combination chemotherapy in treating anaplastic large cell     lymphoma.   "
256710|NCT01974713|"     Longitudinal cohort of patients with chronic kidney disease followed in 3 kidney centers in     Ontario. The goal is to determine whether and how rates of renal disease progression are     affected by inflammatory markers, FGF23 levels, and genetic polymorphisms   "
256711|NCT01964430|"     The purpose of this study is to compare whether there is a delay or prevention of recurrence     or death in subjects with surgically removed pancreatic cancer who then take nab-paclitaxel     in combination with gemcitabine compared to those who take gemcitabine alone.   "
256712|NCT01956929|"     This study is being done to understand metformin's mechanisms of action regarding glucose     production, protein metabolism, and mitochondrial function.   "
256713|NCT01950442|"     Despite improvement in treatment-related morbidity and mortality, esophageal cancer is still     one of the most lethal malignancies. Accurate staging is essential to establish prognosis and     for patient management. Staging helps to determine if surgery, chemotherapy, radiation     therapy, a combination of these, or a palliative approach is the most appropriate.      Endoscopic ultrasound techniques are becoming more and more popular. At Notre Dame Hospital,     Centre Hospitalier de L'Universite de Montreal, all patients diagnosed with esophageal cancer     undergo complete EUS staging. In selected patients, EUS is followed by EBUS during the same     procedure, in order to examine all the lymph nodes near or far from the primary tumor     amenable to EBUS guided trans-bronchial biopsy. In patients with a malignant esophageal     stricture, we have preformed very gentle balloon dilation up to 14 mm. It is important to     realize that this is not to achieve symptom resolution, but rather to allow the passage of     the scope. We hypothesize that earlier reports of higher perforation rates were related to     unnecessary aggressive dilation. Thus far, we have successfully dilated over 60 patients     during the last four years (2009-2013) and were able to pass the scope and complete the     examination in the vast majority of patients with no morbidity.   "
256714|NCT01950390|"     This randomized phase II trial studies how well ipilimumab with or without bevacizumab works     in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal     antibodies, such as ipilimumab and bevacizumab, block tumor growth in different ways by     targeting certain cells.   "
256735|NCT01767194|"     This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide     with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that     has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan     hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and     help kill them or carry tumor-killing substances to them. It is not yet known whether giving     irinotecan hydrochloride and temozolomide together with temsirolimus or dinutuximab is more     effective in treating neuroblastoma.   "
256736|NCT01762202|"     Assessment of safety and efficacy of with fludarabine and cyclophosphamide (FC) combined with     ofatumumab (FCO2) in previously untreated young patients with Chronic Lymphocytic Leukemia     (CLL).   "
256716|NCT01955317|"     Background (brief):        1. Burden:           Neonatal death still unacceptably high in low income countries. The common causes of          neonatal death are pneumonia, sepsis and omphalitis. Many neonatal infections occur          because the mother's hands or the hands of the person who attended the birth are          unclean. Our previous study found that there was substantial concern about excessive          exposure of the mother or the neonate to water during handwashing because of the          perception that frequent contact with water could lead to respiratory illness.        2. Knowledge gap:           Chlorhexidine has been evaluated for use in hand hygiene applications in high-income          countries, particularly in healthcare, but it has not been evaluated or promoted for          hand cleansing at the household level in low- and middle-income countries.        3. Relevance:      A waterless hand cleanser employing chlorhexidine would overcome important barriers to     handwashing with soap, perceptions of cold resulting from exposure to water, and the time     limitations perceived by mothers.      Hypothesis: Mothers who are exposed to a chlorhexidine-based hand cleansing intervention will     clean their hands (with chlorhexidine or soap and water) more frequently than mothers who are     not exposed to the chlorhexidine-based hand cleansing program.      Objectives:      The primary objective        1. To demonstrate the behavioural impact of chlorhexidine-based hand hygiene intervention          on hand cleansing of mothers during the neonatal period The secondary objectives        2. To demonstrate the impact of chlorhexidine-based hand hygiene intervention on hand          cleansing of other family members, visitors to the neonate, and birth attendants during          the neonatal period        3. To evaluate the acceptability of chlorhexidine for hand cleansing in the neonatal period          among mothers, other family members, and birth attendants      Methods:      We propose a randomized controlled trial in a rural area of Bangladesh, with an active     control. Randomization will be at the level of the participating pregnant woman. Each arm     will include 150 participants. All intervention visits will follow baseline data collection.     A trained health and hygiene promoter will carry out two visits in the antenatal period and     one postnatal visit to deliver intervention messages.      Outcome measures:        1. Observed hand cleansing behavior of mother with chlorhexidine or soap and water at          critical times.        2. Observed hand cleansing behavior of other household members and visitors to home with          chlorhexidine or soap and water at critical times.   "
256717|NCT01928290|"     This phase II trial studies how well combination chemotherapy works in treating patients with     advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as     irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor     cells.   "
256718|NCT01912612|"     Early stage breast cancer is typically treated with surgery, chemotherapy, radiation therapy,     and/or endocrine therapy. Following treatment, 25-60% of breast cancer survivors have     reported chronic pain, which can be difficult to manage. Duloxetine is a serotonin     norepinephrine reuptake inhibitor that is FDA approved for treatment of depression, anxiety,     fibromyalgia, diabetic neuropathic pain, knee arthritis, and low back pain.      Pilot data suggest that duloxetine is effective in management of endocrine therapy-associated     musculoskeletal pain, and a randomized placebo controlled trial of duloxetine has     demonstrated efficacy for treatment of chemotherapy-induced neuropathic pain. In this     mechanistic study of duloxetine versus placebo, we will investigate the change in pain     sensitivity with treatment in order to evaluate both why duloxetine is effective for     management of pain for some patients, as well as predictors of who is likely to benefit from     duloxetine. A total of 84 women with early stage breast cancer who have chronic pain     following treatment, as well as 48 women who are pain free, will be enrolled. All subjects     will undergo assessment of pain sensitivity and complete questionnaires. Subjects with pain     will be treated with duloxetine for a total of 7 weeks, with pain sensitivity assessments     before treatment and after 4 weeks of full-dose treatment.   "
256719|NCT01886872|"     This randomized phase III trial studies rituximab with bendamustine hydrochloride or     ibrutinib to see how well they work compared to ibrutinib alone in treating older patients     with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as     rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used     in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth. It is not yet known whether rituximab with     bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in     treating chronic lymphocytic leukemia.   "
256720|NCT01861106|"     Background:      - GATA2 deficiency is a disease caused by mutations in the GATA2 gene. It can cause different     types of leukemia and other diseases. Researchers want to see if a stem cell transplant can     be used to treat this condition. A stem cell transplant will give stem cells from a matching     donor (related or unrelated) to a recipient. It will allow the donor stem cells to produce     healthy bone marrow and blood cells that will attack the recipient s cancer cells.      Objectives:      - To see if stem cell transplants are successful at treating GATA2 mutations and related     conditions.      Eligibility:        -  Recipients who are between 10 and 70 years of age and have GATA2 deficiency.        -  Donors who are between 6 and 70 years of age and are matched with the recipients.      Design:        -  All participants will be screened with a physical exam and medical history. Blood          samples will be collected. Recipients will have imaging studies and other tests.        -  Donor participants will provide stem cells for the treatment. Filgrastim injections will          allow these cells to be collected from the blood. In some cases, bone marrow donations          will be needed to provide more stem cells.        -  Recipients will have chemotherapy or radiation to prepare for the transplant. On the day          of the transplant, they will receive the donated stem cells.        -  Recipients will stay in the hospital until their condition is stable after transplant.        -  Frequent blood tests and scans will be required for the first 6 months after the          transplant, followed by less frequent visits over time.   "
256721|NCT01856192|"     This randomized phase II trial studies how well rituximab and combination chemotherapy with     or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse     large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the     ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as     cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune     system in different ways and stop cancer cells from growing. It is not yet known whether     rituximab and combination chemotherapy are more effective when given with or without     lenalidomide in treating patients with diffuse large B cell lymphoma.   "
256722|NCT01855698|"     The primary objective of the study is to assess efficacy and safety of different prophylactic     or therapeutic antithrombotic approaches in patients with hematologic neoplasms and platelet     count <50 x109/L, including unfractionated or low molecular weight heparin, fondaparinux,     anti-vitamin K agents, antiplatelet agents, novel oral anticoagulants, fibrinolytic agents,     with or without a policy of platelet transfusion. Cases with arterial or venous     thromboembolism managed with observation or use of vena cava filters in patients with venous     thromboembolism will be included too.   "
256725|NCT01819259|"     The overall goal of the proposed research is to evaluate the behavioral and genetic     mechanisms of smoking risk in non-smoking young adults (aged 18-25 years of age) with and     without ADHD using a novel laboratory-based model of intranasal nicotine administration.      Study Hypotheses:        1. that nicotine will produce greater positive and fewer negative/aversive subjective          effects in individuals with ADHD. The study team also hypothesizes that nicotine will          improve performance to a greater degree in those with ADHD.        2. that individuals in the ADHD group will exhibit an increase in choices for nicotine vs.          placebo in both conditions (i.e., main effect) and that this effect will be more          pronounced in the High Demand vs. Low Demand conditions (i.e. Group x Condition          interaction). Also that greater performance enhancing effects of nicotine will be          associated with greater nicotine choice during the high demand cognitive condition.        3. that the main effects of ADHD status on nicotine reinforcement will be heightened in the          presence of certain genotypes. Also that the main effects of ADHD status on nicotine          reinforcement will be heightened in the presence of certain genotypes. Finally that          exposure to nicotine will alter epigenetic patterns in DNA   "
256726|NCT01815580|"     This study will recruit men and transgender women with acute or recent HIV infection. It wil     look at how HIV medicines (ART) when given very early after HIV infection affect the amount     of HIV in the blood, semen and rectal secretions. In addition, Investigators will be using     modeling studies to look at whether or not this kind of HIV treatment can decrease the risk     that a man will infect a person he has sex with and to find out how failure to take     medications will impact spreading the virus to other people.      In this study, one group will be randomized (like a coin toss) to start ART immediately (just     at the time of the enrollment visit) and the other group will wait until week 24 of the study     to start ART. Both groups will be followed for a total of 48 weeks and will continue to     receive ART from local sources after the study is over.   "
256727|NCT01813539|"     The purpose of this study is to determine the recommended Phase 2 dose of ARGX-110, an     antibody that binds CD70, in patients with advanced malignancies.   "
256728|NCT01802333|"     This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or     idarubicin and cytarabine with or without vorinostat to see how well they work in treating     younger patients with previously untreated acute myeloid leukemia. Drugs used in     chemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat,     work in different ways to stop the growth of cancer cells, either by killing the cells,     stopping them from dividing, or by stopping from spreading. Giving more than one drug     (combination chemotherapy) and giving the drugs in different doses and in different     combinations may kill more cancer cells. It is not yet known which combination chemotherapy     is more effective in treating acute myeloid leukemia.   "
256729|NCT01794403|"     Accelerated Hypofractionation Radiotherapy for prostate cancer of 36.25 Gy delivered in 5     fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions     with respect to two-year failure defined as a positive biopsy two years post treatment     completion or earlier evidence of biochemical or clinical failure.   "
256730|NCT01793883|"     This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus     placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who     present to clinic with symptomatic presumptive influenza A or B infection.   "
256731|NCT01791101|"     This is a Phase II multicentre study. Patients will be administered eltrombopag 50 mg/daily.     If patients don't achieve response after 2 months of therapy they will stop eltrombopag; if     patients will achieve response after 2 months of therapy, they will continue eltrombopag for     a maximum period of 24 months; 40 patients are needed. In stage I, 22 patients will be     enrolled; if ≤ 4 responses at the first evaluation after 2 months (18%) will be seen, the     trial will be stopped; if 5 or more responses will be seen, the accrual will continue. In     stage II, 18 more patients will be enrolled. If ≤ 12 (30%) responses will be observed out of     40 patients, it will be concluded that the study drug is not active enough. If ≥ 13 responses     will be observed, it will be concluded that eltrombopag is worth of further studies.   "
256732|NCT01787682|"     Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic     obstructive pulmonary disorder (COPD), negatively influencing their quality of life,     treatment response and survival. Loss of muscle protein is generally a central component of     weight loss in CHF and COPD patients but patients also have reductions in fat mass and bone     density, independent of the severity of the disease state. The purpose of this     cross-sectional study is to provide detailed insight in disease related gut function by     obtaining information on gut permeability, digestion and absorption of glucose, fat and     protein in CHF and COPD patients compared to matched healthy controls. This will provide     required information that is necessary to implement new strategies to develop optimal     nutritional regimen in CHF and COPD. The hypothesis is that CHF and COPD are related to     decreased gut function and absorption, leading to decreased anabolic response. Second, this     decreased nutritional status is linked to reduced muscle functioning and possibly decreased     cognition. In addition, we will examine the effect of aging on by comparing gut function     digestion and absorption of the CHF and COPD aged matched healthy controls to a group of     young healthy subjects.   "
256733|NCT01776424|"     The primary purpose of this study is to evaluate whether treatment with rivaroxaban and     aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks,     stroke or cardiovascular death in patients with coronary or peripheral artery disease.   "
256734|NCT01787929|"     The purpose of this study was to identify the clinical relevance of cementless     hemiarthroplasties, compare Harris functional score.The hypothesis is the non-inferiority of     cementless hemiarthroplasties compare cemented hemiarthroplasties in order to justify the     relevance of cementless hemiarthroplasties in displaced femoral neck fractures.      150 patients will be included, 75 with cemented hemiarthroplasty and 75 with uncemented     hemiarthroplasty. They will be followed during one year after the surgery, with a     functionality assessment at 3 month and 12 month.   "
256804|NCT00892866|"     This research trial studies carbonic anhydrase 9 (CA-IX), p16, proliferative markers, and     human papilloma virus (HPV) in diagnosing cervical lesions in patients with abnormal cervical     cells. Studying biomarkers in abnormal cervical cells may improve the ability to find     cervical lesions and plan effective treatment.   "
256738|NCT02007226|"     Although conventional risk factors for coronary heart disease (CHD) have been identified and     routinely used to determine risk for CHD in the general population, a systematic approach to     determine population-specific risk for CHD has not been performed prospectively in those with     SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages than in     the able-bodied population. Conventional risk factors for CHD are high serum concentrations     of low-density lipoprotein (LDL), low serum concentrations of high-density lipoprotein (HDL),     diabetes mellitus (DM), positive smoking history, and positive family history of premature     CHD.      Coronary Artery calcification (CAC) is a commonly occurring phenomenon that does not     necessarily indicate significant obstructive disease. Studies have shown that a strong     association exists between coronary calcification and coronary heart disease. The purpose of     this study is to compare the CAC scores in persons with SCI with a historical control group     of able-bodied persons from a national data base who will be matched for conventional risk     factors for coronary artery disease (CAD) and to determine the relationship between CAC     scores and conventional and emerging risk factors for CAD. Additionally, postprandial lipemic     (elevated levels of lipids following ingestion of food) responses among individuals with SCI     and control subjects will be compared, as well as the response of inflammatory markers     following a high fat meal. Participants will only be tested once for these parameters.   "
256739|NCT01750918|"     This is an open-label, four-part Phase I/II study to investigate the safety,     pharmacokinetics, pharmacodynamics and clinical activity of trametinib (GSK1120212) and     dabrafenib (GSK2118436) when administered in combination with the anti-EGFR antibody     panitumumab in subjects with BRAF-mutation V600E positive colorectal cancer (CRC) and in     subjects with CRC with secondary resistance to prior anti-EGFR therapy. Part 1 of the study     will consist of dose-escalation cohorts, following a 3 + 3 enrollment scheme. Part 2 of the     study will consist of expansion cohorts to investigate safety and clinical activity of     dabrafenib in combination with panitumumab and trametinib plus dabrafenib in combination with     panitumumab. Part 3 of the study will be a randomized Phase II study comparing dosing with     dabrafenib in combination with panitumumab and trametinib plus dabrafenib in combination with     panitumumab as compared to the chemotherapy comparator (a regimen of leucovorin calcium,     fluorouracil, oxaliplatin (FOLFOX), leucovorin calcium, fluorouracil, irinotecan     hydrochloride (FOLFIRI) or irinotecan with or without panitumumab or bevacizumab). Subjects     will be assigned to treatment groups in a randomized fashion to compare safety and clinical     activity. Part 4 of the study will investigate the trametinib/panitumumab combination,     including dose escalation and subsequent cohort expansion in two patient populations: 1)     BRAF-mutation V600E positive CRC and 2) subjects with CRC who developed secondary resistance     to prior anti-EGFR therapy. The objective of Part 4 is to identify the recommended Phase 2     dose/regimen for trametinib dosed in combination with panitumumab in dose escalation and to     identify an initial signal of clinical activity in expansion cohorts.   "
256740|NCT01738490|"     The overall aim of the study is to investigate the Ponto wide implant considering; initial     implant stability, stability over time, skin reaction and long term success when loaded at 3     weeks post surgery. Patients' quality of life improvements following implantation will also     be surveyed.      More specifically the primary objective of this clinical study is to test the hypothesis        -  The new Ponto wide diameter implant offers increased implant stability measured as ISQ          (implant stability quotient) compared to the previous generation Ponto implant.      And the secondary objective is to        -  Investigate when in time implant stability is the lowest as the initial mechanical          stability is gradually replaced by biological stability   "
256741|NCT01734928|"     The purpose of this study is to compare the efficacy of the combination of Pomalidomide,     Bortezomib and Dexamethasone to the combination of Bortezomib and Dexamethasone in patients     with relapsed/refractory multiple myeloma. This study will also assess how safe the     combination of Pomalidomide, Bortezomib and Dexamethasone is compared to the combination of     Bortezomib and Dexamethasone   "
256742|NCT01757535|"     This study will enroll approximately 460 subjects, aged 55 or older, with a diagnosis of de     novo AML (Acute Myeloid Leukemia) or AML secondary to prior myelodysplastic disease or     chronic myelomonocytic leukemia (CMML), and who have achieved first Complete remission (CR)/     Complete remission with incomplete blood count recovery (CRi) following induction with or     without consolidation chemotherapy. Subjects who have previously achieved CR/CRi with a     hypomethylating agent will be excluded from the study.   "
256743|NCT01728714|"     Prospective study to evaluate the impact of an educational programme about diabetes,     comparing to normal clinical practice, on treatment compliance and disease control of people     with type 2 diabetes followed in the primary care units in Portugal.   "
256744|NCT01723566|"     Understanding the clinical practice of treatment of cardiac rhythm disorders all over the     world and understanding the clinical outcomes of the treatment with its cardiac rhythm     products in real world patient population is essential for Medtronic to be able to     effectively develop new products and adjust existing products. In addition Medtronic is     committed to monitor the safety of its products throughout the entire life cycle to ensure     maximum product reliability.      The Panorama 2 registry will enable Medtronic to increase data collection of clinical     practice with Medtronic implantable Cardiac Rhythm and Disease Management (CRDM) devices in     various regions across the world and on product reliability of its CRDM devices.   "
256745|NCT01730222|"     Four-drug combo yielded a statistically significant improvement in progression-free survival     and overall survival compared to gemcitabine in patients with advanced pancreatic     adenocarcinoma. Nab-Paclitaxel showed promising antitumor activity in patients with     pancreatic cancer. Given the synergism of taxanes with gemcitabine, fluoropyrimidines and     platinating agents the role of nab-Paclitaxel in a 4-drug regimen will be explored.      The aim of this trial is to determine the recommended dose of nab-paclitaxel in combination     with cisplatin, capecitabine, and gemcitabine, PAXG regimen (Phase I), and to evaluate the     feasibility and the activity of the PAXG regimen in patients with stage III and IV pancreatic     cancer.   "
256746|NCT01699217|"     The GIMEMA CML Working Party promotes a multicentre, observational, prospective study of CML     patients treated frontline with NIL. Patients will be followed for 5 years. This study will     help the definition of guidelines for the treatment of CML patients in early CP.   "
256747|NCT01677741|"     This is a 2-part, study to determine the safety, tolerability and pharmacokinetics of oral     dabrafenib in children and adolescent subjects with advanced BRAF V600 mutation-positive     solid tumors. Part 1 (dose escalation study) will identify the recommended Part 2     (tumor-specific expansion study) dose and regimen using a dose-escalation procedure.     Approximately 6 to 18 subjects will participate in Part 1 and will receive a starting dose of     3 mg/kg and dose will deescalate or escalate between 1.5 milligram (mg)/kilogram (kg) and 6     mg/kg. Up to 6 subjects will be enrolled at one dose level dependent upon the number of     subjects at the current dose level, the number of subjects who have experienced a dose     limiting toxicity (DLT) at the current dose level, and the number of subjects enrolled but     with data pending at the current dose level. Escalation may proceed until either a maximum     tolerated dose (MTD) is established, or until the dose in which the median pharmacokinetic     parameters consistent with exposure in adults are achieved. Cohorts may be added in order to     evaluate additional dose levels. Part 2 consists of four disease-specific cohorts of subjects     with tumors known to have BRAF V600 activation (pediatric low-grade gliomas, pediatric     high-grade gliomas, Langerhans cell histiocytosis [LCH], and other tumors such as melanoma     and papillary thyroid carcinoma [PTC]). Each cohort will enroll at least 10 subjects with a     pre-dose and at least 1 post-dose disease assessment. In both the parts of the study, on Day     1, a single first dose will be administered, and repeat dosing will begin on Day 2. PK     sampling will be performed on Day 1 and Day 15 for subjects >=25 kg in weight. For subjects     <25 kg and >=10 kg in weight, blood samples for PK analysis will be collected on Day 1 and     Day 15. For subjects <10kg in weight, blood samples for PK analysis will be collected after     repeated administration on Day 15 only. Safety and tolerability will be assessed throughout     the study. Treatment with dabrafenib will be continued until disease progression or until no     clinical benefit or development of an unacceptable toxicity, or until they withdraw consent     or begin a new therapy. At the end of treatment, a final study visit will occur.   "
256748|NCT01641107|"     Drug resistance resulting from emergence of Imatinib-resistant BCR-ABL clones is a     significant problem in Ph positive ALL patients because after a very good initial response to     one TKI inhibitor, many patients relapse within one year, relapse being almost always     associated with a BCR-ABL kinase domain point mutation. The patients who relapse after     treatment with one TKI can be rescued to remission with another TKI, but the second remission     is usually shorter than the previous one. A more potent TKI inhibitor, and pan-active not     only on all the BCR-ABL variants (including the second generation TKI resistant T315I     mutant), but also on others molecular targets can do better. In this context, Ponatinib is a     novel synthetic orally active tyrosine kinase inhibitor (TKI), specifically developed to     inhibit BCR-ABL, the fusion protein that is the product of the Philadelphia chromosome (Ph)     in chronic myeloid leukemia (CML) and in a subset of acute lymphoblastic leukemia (Ph+ ALL).     It potently inhibits the BCR-ABL protein as well as mutated forms of the protein that arise     in patients resistant to prior therapies with TKIs. Ponatinib has been demonstrated to     inhibit all the mutations that have been detected so far, in vitro and in vivo and to     uniformly suppress the emerge of single-mutant clones in a mutagenesis assay. In the Phase II     study, 41% of Philadelphia chromosome positive acute lymphoblastic leukemia patients treated     with Ponatinib achieved major hematologic response, 47% had a major cytogenetic response, 38%     obtained a complete cytogenetic response, showing that Ponatinib provides significant benefit     despite previous intolerance or refractoriness to other TKIs. The Phase I trial showed that     patients with a more recent diagnosis had increased rates of major molecular response: 79%     for 14 patients with 0 to 5 years since diagnosis vs. 29% for 14 patients with more than 5 to     9 years since diagnosis (P=0.02) and 27% for 15 patients with more than 9 to 24 years since     diagnosis (P=0.009). These characteristics support the hypothesis for a role of Ponatinib not     only in patients resistant to prior TKI therapy but also in untreated ALL Ph+ patients, in     order to prevent the emergence of resistant caused by the selection of mutated Ph+ clones and     in order to avoid rapid progression of the disease.   "
256749|NCT01633931|"     The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat     patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.   "
256750|NCT01621893|"     Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty     procedure including changes in pain, function, and overall health.   "
256751|NCT01601301|"     The purpose of this study is to obtain post market performance and safety data of the Ellipse     PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb     lengthening.   "
256752|NCT01594229|"     This is a Phase 1, open-label, multicenter study evaluating the safety, pharmacokinetic     profile, and preliminary efficacy of ABT-199 in combination with Bendamustine/Rituximab in     approximately 60 subjects with relapsed or refractory non-Hodgkin's lymphoma. This study will     evaluate the safety and pharmacokinetic profile of ABT-199 in approximately 60 subjects when     administered in combination with Bendamustine/Rituximab following a dose escalation scheme,     with the objective of defining the dose limiting toxicity and the maximum tolerated dose.   "
256753|NCT01566695|"     Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus     Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent     anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk     myelodysplastic syndromes (MDS).   "
256763|NCT01471249|"     This study consists of a prospective clinical trial which aims to evaluate the impact of     stent insertion for palliation of malignant dysphagia. The main goal being to examine the     number of days required following stenting in order to have significant improvement in     dysphagia and the length of time that this baseline is maintained. Approximately 100 patients     will be prospectively enrolled in this study.      Patients with end stage inoperable esophageal cancer deemed candidates for intraluminal     esophageal palliative stent insertion will be prospectively enrolled into the study. Patients     with esophageal obstruction or stricture due to other benign causes, tumors obstructing the     cervical esophagus, as well as patients with airway-esophageal fistulas will be excluded from     the study.      The investigators plan to evaluate the efficacy of intra-esophageal stent insertion to     improve malignant dysphagia as a main factor affecting the quality of life in these patients.   "
256754|NCT01621646|"     Cognitive impairment is also a major risk factor for development of dementia later in life.     Findings from our studies suggest that the carotenoids, lutein and zeaxanthin may be     important in cognitive function in the elderly. The investigators have previously reported     eggs to be a highly bioavailable source of lutein and zeaxanthin. Our study evaluates     long-term egg intervention as a treatment strategy for age-related cognitive impairment which     could possibly prevent the onset of dementia. The investigators have also shown that lutein     supplementation significantly improved verbal fluency scores in healthy older women. Our     studies have shown that egg interventions can significantly increase serum lutein     concentrations in older adults. Based on the sum of our findings, the next logical step will     be to investigate the ability of lutein and zeaxanthin contained in eggs to influence     cognitive function in older adults. The investigators hypothesize that there will be a     significant increase in cognitive function measures in older adults provided with meals     containing 2 egg/day at the end of 6 months, while no significant improvements will be     observed in older adults given daily meals containing egg substitute.      The proposed study is designed as a randomized, placebo controlled trial that tests the     effects of 6 month supplementation with 2 eggs/day on cognitive function in older adults.     Secondary analyses will determine whether baseline MP density predicts relative effectiveness     of the intervention on cognitive function. Secondary outcomes include plasma biomarkers of     oxidative stress and inflammation.   "
256755|NCT01638936|"     The purpose of this study is to test safety and anti-tumor activity of BT062 in combination     with lenalidomide and dexamethasone to define the best doses for treating patients with     relapsed and refractory multiple myeloma.   "
256758|NCT01485042|"     3 STUDY RATIONALE Based upon the above rationale, the investigators propose a phase I study     combining Pazopanib with TH-302 in advanced solid tumors. Pazopanib is FDA approved at a dose     of 800mg per day. Using this dose ensures consistency with standard clinical use. It also     ensures using the dose most likely to induce maximal hypoxia, which in turn will help ensure     maximal local activation of TH-302 (a hypoxia activated prodrug). TH-302 can be given as     monotherapy at a weekly dose of 575 mg/m2. When TH-302 is combined with full doses of various     chemotherapeutics, the recommended dose of TH-302 has ranged from 240 to 480 mg/m2. Little     overlapping toxicity between TH-302 and pazopanib is expected. However to ensure patient     safety, the starting dose for the combination will be conservative and use the TH-302 dose     found safe with the majority of cytotoxic agents, 340 mg/m2 given days 1,8, 15 on an every 28     day cycle.      Using a standard 3+3 design, the investigators will add increasing doses of TH-302 (340     mg/m2, 480 mg/m2, 575 mg/m2 given weekly, 3 weeks on/1 week off (the standard TH-302 dosing     schedule) to the full monotherapy dose of pazopanib (800 mg p.o daily) with expected accrual     ranging from 12-18 subjects. Once the recommended phase II dose is identified, the     investigators will then enroll an expanded cohort of approximately 12-18 (i.e. total of 30     subjects overall) patients to better define the tolerability of this study drug combination.      4 STUDY OBJECTIVES 4.1 Primary        -  To define the maximal tolerated dose (if any) and the recommended phase II doses for the          combination of pazopanib plus TH-302 in patients with advanced solid tumors 4.2          Secondary        -  To describe any dose limiting and non dose-limiting toxicities of this drug combination   "
256759|NCT01483027|"     The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal     cancer with metastases in the liver, who are scheduled to receive second line chemotherapy.     All patients receive the standard of care chemotherapy with or without the addition of     TheraSphere.   "
256760|NCT01494935|"     The investigators will determine whether people with high muscle mitochondrial capacity     produce higher amount of reactive oxygen species (ROS) on consuming high fat /high glycemic     diet and thus exhibit elevated cellular oxidative damage. The investigators previously found     that Asian Indian immigrants have high mitochondrial capacity in spite of severe insulin     resistance. Somalians are another new immigrant population with rapidly increasing prevalence     of diabetes. Both of these groups traditionally consume low caloric density diets, and the     investigators hypothesize that when these groups are exposed to high-calorie Western diets,     they exhibit increased oxidative stress, oxidative damage, and insulin resistance. The     investigators will compare Somalians and NE Americans who are matched for age, BMI, and sex.     The investigators will measure ROS production in skeletal muscle following high fat/high     glycemic diet vs. healthy diet. The investigators will compare the oxidative damage to     proteins, DNA, and lipids in these two populations following 10 days of high fat/high     glycemic index diet in comparison with low fat diet. The investigators will determine if     elevated levels of oxidative damage in Somali immigrant populations is accompanied by high     mitochondrial capacity, higher ROS-emitting potential, and lower insulin sensitivity than NE.     The proposed study will be performed utilizing the state-of-the-art proteomic and metabolomic     methods many of which were recently developed in our laboratory. The investigators expect the     results from this study to provide seminal insights into the underlying mechanism of insulin     resistance and type 2 diabetes, in addition to demonstrating mechanisms by which a functional     proteome is maintained in vivo.   "
256761|NCT01511913|"     The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the     treatment of unresectable or metastatic melanoma in the post-approval setting.   "
256762|NCT01475110|"     The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study     of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollment     will include all patients who started Nilotinib between January 2005 and December 2012.     Patients will be followed for 4 years since treatment start. After this time, survival data,     disease status and treatment will be recorded at 6-months-interval. This study will help the     definition of guidelines for a proper management of Nilotinib in any-phase CML patients.   "
256766|NCT01450033|"     Adolescents with solid organ transplants have poorer outcomes than adults, and do not respond     as well to post-rejection treatment. In addition to well-recognized declines in individual     health-related quality of life, premature graft loss creates considerable health and economic     burdens. High nonadherence rates among adolescents are believed to contribute majorly to     rejection, premature allograft dysfunction and failure. Studies suggest that a     telephone-based peer mentoring approach, with texting and e-communication, is a promising,     practical means to promote medication adherence in adolescent solid organ transplant     recipients. The study's main objectives are 1) to determine the efficacy of peer mentoring to     improve medication adherence and health-related quality of life vs. usual care in adolescents     and young adults with solid organ transplants, and 2) to determine the mechanisms through     which peer mentoring impacts medication adherence and health-related quality of life.   "
256767|NCT01501461|"     The intent of this clinical study is to answer the questions:        1. Is the proposed treatment safe        2. Is treatment effective in improving the health of patients with human frailty syndrome.   "
256768|NCT01453764|"     The intent of this clinical study is to answer the questions:        1. Is the proposed treatment safe        2. Is treatment effective in improving the disease pathology of patients with Multiple          Sclerosis and clinical outcomes?   "
256769|NCT01448395|"     A study to look at how radiolabelled NXL104 is taken up, broken down and removed by the body     when given as an injection into the blood stream.   "
256770|NCT01440244|"     Although thoracic NOTES may not be ready for human trials, a new minimally invasive technique     to access the pleural cavity and perform pleural, pulmonary and mediastinal procedures would     be possible. Cervical Video Assisted Thoracoscopic Surgery (C-VATS) is a technique that     borrows from traditional VATS procedures, from cervical mediastinoscopy, and from flexible     endoscopy. All of these procedures are very familiar to the thoracic surgeon.      The current feasibility and safety study examines C-VATS as a method of evaluating, biopsying     and performing pleurodesis in patients with pleural disease and or effusion.   "
256771|NCT01430910|"     This is a randomised study divided into 2 parts. Part A investigates the effect of prolonged     dosing (ten days) with Avibactam and Ceftazidime when given together and how this will effect     how much Avibactam and Ceftazidime enters the blood. Part B investigates how much Avibactam     (NXL104) and Ceftazidime enter the blood when Avibactam and Ceftazidine are given separately     or together intravenously.   "
256772|NCT01411345|"     1. The investigators hypothesize that increasing radiation dose to the functional          MRI-defined lesion in the prostate bed will result in an improved initial complete          response (reduction in prostate-specific antigen (PSA) to < 0.1 ng/mL), which is related          to long-term outcome biochemically.        2. Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor          regions.        3. 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that          are related to an adverse treatment outcome.        4. Prostate cancer-related anxiety will be reduced in the MRI targeted SRT arm, because the          patients will be aware that the dominant tumor will be targeted with higher radiation          dose.   "
256773|NCT01395420|"     This is an open-label study divided in 2 parts and 3 cohorts to determine the concentration     of Avibactam and Ceftazidime in the lining of the lungs and the blood.   "
256774|NCT01393483|"     The purpose of this study is to find out whether a protein, called mesothelin, found in the     blood and tissue can be used as marker for esophageal cancer. Doctors at Memorial     Sloan-Kettering Cancer Center would like to compare levels of this protein in patients with     abnormal cells or tissue of the esophageal to the levels of this protein in patients being     treated for cancer for the esophagus.   "
256775|NCT01364597|"     This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects     with epilepsy.   "
256776|NCT01362881|"     It is current practice for children who have surgery for early onset scoliosis (EOS) to be     treated with insertion of extendable implants known as growth rod systems. This allows the     growth potential of the child to be maximised during the period of growth. However, the child     must undergo an average of 6 further surgeries to lengthen the rods every 6 months. Sometimes     this may continue for several years. This requires repeated general anaesthesia and places     the patient at risk of complications as well as on-going costs to the hospital with each     admission and theatre episode.      Magec is a magnetic growth rod from Ellipse technologies (distributed by SurgiC). The rod is     inserted in exactly the same way as the conventional growth rod systems. The base implants     i.e screws and hooks remain the preferred choice of the user. The only change is that a     different rod is used.      There are several advantages to this device. Firstly, after the initial insertion, further     lengthenings, unlike current systems, do not need to be carried out in theatre under a     general anaesthetic. In contrast, they can be done in an outpatients setting with a     non-invasive technique. The rods are lengthened using an external magnetic device. The     lengthenings are done in a controlled manner using an age related growth guide. Thirdly, the     change from a theatre based intervention to an outpatient procedure will have cost-savings.     The investigators also believe that there will be psychosocial benefits to the child and     family by the avoiding the stress associated with repeated surgery at such a young age.      In terms of risk assessment the device does not place the child at any more risk than would     be expected from inserting any of the existing systems. In the event of failure of the rods     the worst outcome is a revision to conventional rods.   "
256777|NCT01361438|"     This study will enroll adult de novo Ph+ acute lymphoblastic leukemia (ALL) patients (≥18     years, ≤60 years). Induction treatment will consist of 12 weeks of Dasatinib oral     administration (140 mg QD). Patients will initiate treatment with steroids 7 days prior to     starting Dasatinib and will continue up to day 31. Patients will continue treatment with     Dasatinib up to day 84, except for disease progression, intolerable toxicity, or withdrawal     from study.   "
256778|NCT01295944|"     The goal of this clinical research study is to learn if the combination of bevacizumab and     carboplatin can help to control recurrent pendymoma. The safety of this drug combination will     also be studied....   "
256779|NCT01291602|"     This is a single and multiple dose study in healthy male and female (of non-childbearing     potential) Japanese volunteers, to assess the safety, tolerability, and blood and urine drug     levels of intravenous (IV) NXL104 alone and when given in combination with ceftazidime.   "
256782|NCT01289444|"     Our goal is to advance palliative care to adolescents and their families. We hope our study     will decrease suffering (psychological, spiritual, physical) and increase quality of life     (QOL). Left unprepared for end-of-life decisions, miscommunication and disagreements may     result in families being charged with neglect or court battles over treatment choices. FAmily     CEntered (FACE) Advance Care Planning helps prepare adolescents with HIV/AIDS and their     families for future medical decisions. We hope to increase families' understanding of their     teens' wishes for end-of-life care and to decrease conflict. We will also study communication     and spiritual struggle Families will be randomized into the either the Control (N=65     families) or FACE Intervention (N=65 families). FACE families will meet with a     trained/certified researcher for three 60- to 90-minute sessions scheduled one week apart:     Session 1: Lyon Advance Care Planning Survey© - Adolescent and Surrogate Versions: Session 2:     The Respecting Choices Interview® Session 3: Completion of The Five Wishes©. Control families     will also meet with a researcher for three 60-to 90-minute sessions scheduled one week apart:     Session 1: Developmental History, Session 2: Safety Tips, and Session 3: Nutrition.     Questionnaires will be administered five times, when first seen, at 3, 6, 12 and 18 months     from the time of Session 3. Hypothesis 1: Compared to an active control, FACE will relieve     psychological suffering by 1) increasing congruence in treatment preferences between teens     with AIDS and their surrogates, 2) decreasing decisional conflict regarding EOL decision     making for future medical treatment in adolescents with AIDS; 3) increasing quality     communication about EOL care in adolescent/legal guardian or surrogate dyads; 4) and     maximizing QOL.      Hypothesis 2: In addition to the direct effects, FACE will also indirectly affect QOL through     dimensions of threat appraisal.      Hypothesis 3: FACE will have stronger effects on the QOL measures among patients who have     less spiritual struggle.      Hypothesis 4: Spiritual struggle has both direct and indirect effects on     hospitalization/dialysis use. FACE will also affect hospitalization/dialysis use indirectly     through threat appraisal and HAART adherence.   "
256783|NCT01275677|"     This randomized phase III clinical trial studies chemotherapy with or without trastuzumab     after surgery to see how well they work in treating women with invasive breast cancer. Drugs     used in chemotherapy work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving     more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill     more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor     cells and help kill them or carry tumor-killing substances to them. It is not yet known     whether combination chemotherapy is more effective with trastuzumab in treating breast     cancer.   "
256784|NCT01274338|"     This randomized phase III trial studies ipilimumab to see how well it works compared to     high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that     has been removed by surgery. Monoclonal antibodies, such as ipilimumab, may interfere with     the ability of tumor cells to grow and spread. Interferon alfa-2b may interfere with the     growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known     whether ipilimumab is more effective than interferon alfa-2b in treating patients with     melanoma.   "
256785|NCT01272037|"     This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole,     letrozole, or exemestane with or without chemotherapy work in treating patients with breast     cancer that has spread from where it began in the breast to surrounding normal tissue     (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using     tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor     cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast     cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. It is not yet known whether giving     tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination     chemotherapy in treating patients with breast cancer.   "
256786|NCT01268553|"     The purpose of this study is to assess tolerability and clinical effects of transition from     intravenous (IV, needle in the vein) or subcutaneous (SQ, needle in the skin) to the     recently-approved inhaled treprostinil (Tyvaso) for the treatment of pulmonary arterial     hypertension (PAH).      Our hypothesis is that the transition to inhaled treprostinil will be tolerated by patients.      The intravenous and subcutaneous drugs epoprostenol and treprostinil received approval for     treatment of PAH many years ago. While these medications improve exercise capacity and the     symptoms of PAH, they are given by injection and thus have several side effects, such as pain     and catheter infection. This has resulted in many patients either refusing to take the     medication or quitting these medications because of not tolerating them.      The only other form of prostacyclin treatment available for PAH patients is inhaled. There     are 2 inhaled prostacyclins approved for PAH, however one of these requires at least 6     inhalations per day, every day, and takes about 30 minutes to inhale each time. Thus, it has     not been a regularly-used medication and issues surrounding compliance make it a riskier drug     to use if patients do not get their full doses every day. The other inhaled medication,     treprostinil, was approved a few months ago, only needs to be given 4 times a day, and takes     about 2-3 minutes to inhale.      Since inhaled treprostinil can be administered easily, it is anticipated that many patients     will transition from epoprostenol or treprostinil to the recently approved inhaled     treprostinil, however we do not know if this is a safe or effective way to manage patients.     Thus, the goal of this prospective study is to gather observational data regarding how that     switch is made, tolerability of the switch, and, to the extent possible with this     methodology, assess clinical effects of the switch.      This is a prospective study. Twenty patients > 18 years old with PAH will be enrolled.     Patients enrolled will be those in whom a clinical decision to convert from either IV     epoprostenol, IV treprostinil, or SQ treprostinil to inhaled treprostinil therapy has been     made. This is usually the result of patients asking to switch to inhaled therapy, but only     allowed by physicians if they feel the switch would be safe.      If eligible, and after informed consent, patients will have a history and physical     examination, a 6 min walk test, a cardiopulmonary exercise test (CPET), blood tests, and a     symptom questionnaire will be filled out. Patients will then be admitted to the hospital     where a monitoring catheter will be placed inside the patient's heart and inhaled     treprostinil will be initiated, while the dose of IV/SQ medication is reduced over about     24-26 hours.      Clinical follow-up will be at weeks 1, 4, and 12.      The procedures above are all part of the routine clinical care that patients would receive if     they were to be transitioned to inhaled therapy, including the hospitalization and     catheterization. The criteria for them to be able to be switched are conservative. Pressure     in their heart and lungs must be low (mPAP < 40 mmHg and RAP <12 mmHg on catheterization),     and their dose of IV or SQ medication must be low (< 20 ng/kg/min). Regarding the patient     subset enrolled in this study in whom a clinical decision to convert transition therapy has     been made, we will try to ensure that our clinical decision-making will not be influenced by     the need to enroll subjects in the study by explicitly noting the potential for conflict of     interest with each patient (addressed in the ICF). We will not make a clinical decision for     our patients based on the desire to fill the study numbers, and every will be made to avoid     the potential for a perceived conflict of interest.   "
256787|NCT01244893|"     The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to     process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process     qualification (postPQ).   "
256788|NCT01226316|"     This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in     patients with advanced cancer - and to identify a dose and schedule that can be used in the     future. This study will also investigate how the body handles AZD5363 (ie, how quickly the     body absorbs and removes the drug). This study will also investigate anti-tumour activity of     AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid     cancers bearing either AKT1 / PIK3CA or PTEN mutation.   "
256789|NCT01202864|"     The purpose of this study is to find risk factors for hemorrhagic stroke, specifically     intracerebral hemorrhage (ICH), among Caucasians, African Americans, and Hispanics.   "
256790|NCT01198158|"     This randomized phase III trial studies giving everolimus together with bevacizumab to see     how well it works compared to everolimus alone in treating patients with advanced kidney     cancer that progressed after first-line therapy. Everolimus may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     bevacizumab, can interfere with tumor growth by blocking the ability of tumor cells to grow     and spread. Everolimus and bevacizumab may also stop the growth of kidney cancer by blocking     blood flow to the tumor. It is not yet known whether giving everolimus together with     bevacizumab is better than everolimus alone in treating patients with advanced kidney cancer     that has progressed after first-line therapy.   "
256791|NCT01169337|"     This randomized phase II/III trial studies how well lenalidomide works and compares it to     observation in treating patients with asymptomatic high-risk asymptomatic (smoldering)     multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system     in different ways and stop cancer cells from growing. Sometimes the cancer may not need     treatment until it progresses. In this case, observation may be sufficient. It is not yet     known whether lenalidomide is effective in treating patients with high-risk smoldering     multiple myeloma than observation alone.   "
256792|NCT01156883|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving more than one     drug (combination chemotherapy) together with steroid therapy may kill more cancer cells.      PURPOSE: This clinical trial is studying the side effects of combination chemotherapy in     treating young adult patients with acute lymphoblastic leukemia.   "
256805|NCT00882037|"     The primary goal of this study is to identify factors which may put a person that has used     methamphetamine at greater risk for mental and physical health problems and social problems     and factors that may lessen the risk for these problems. This study will also compare     methamphetamine use between Latino and non-Latino persons and those that live in a rural area     or urban area. The investigators hypothesis is that rural persons with methamphetamine     dependence will have greater socio-demographic, bio-psychosocial and behavioral risk factors     than their urban counterparts.   "
256793|NCT01150630|"     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin,     epirubicin hydrochloride, and capecitabine, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving     gemcitabine hydrochloride, with or without cisplatin, epirubicin hydrochloride, and     capecitabine before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed. Giving these drugs after surgery may kill any tumor cells that     remain after surgery.      PURPOSE: This randomized phase II/III trial is studying how well gemcitabine hydrochloride,     with or without cisplatin, epirubicin hydrochloride, and capecitabine, works when given     before and/or after surgery in treating patients with stage I or stage II pancreatic cancer     that can be removed by surgery.   "
256794|NCT01144338|"     This study will compare the impact of including exenatide once weekly in addition to usual     care vs. usual care without exenatide on major cardiovascular outcomes as measured by the     primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction     (MI), or nonfatal stroke.   "
256795|NCT01122368|"     Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will     be treated early with micafungin or placebo to determine the incidence and time to     confirmation of fungal infection.   "
256796|NCT01076205|"     The primary objective of the study is to explore the therapeutic success, measured by     improvements in the following variables :        -  The number of missed working days      The secondary objective is to document the therapeutic success by the following variables:        -  The number of physician visits        -  The number and duration of hospitalization        -  The number of days of impairment in non-occupational activities        -  The duration of morning stiffness, pain, exhaustion/fatigue   "
256797|NCT01074970|"     The purpose of this trial is to evaluate 2-year disease-free survival in this patient     population treated with single agent cisplatin and patients treated with cisplatin in     combination with Rucaparib following preoperative chemotherapy. Side effects and tolerability     of this treatment in patients with residual disease following preoperative chemotherapy will     also be observed and characterized.   "
256798|NCT01062360|"     The purpose of this study is compare efficacy and tolerability of a fixed combination,     containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single     components in patients with sore throat and nasal congestion.   "
256799|NCT01013649|"     This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without     erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation     therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was     removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride,     capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor     cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation     therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known     whether chemotherapy is more effective when given with or without erlotinib hydrochloride     and/or radiation therapy in treating pancreatic cancer.   "
256800|NCT01000493|"     This is a 12-week, randomized, multicenter, double-blind, placebo controlled, fixed-dose     parallel group study to assess the efficacy and safety of orvepitant (60 mg/day) versus     placebo in subjects with a diagnosis of noncombat-related Posttraumatic Stress Disorder     (PTSD), whose symptoms are considered moderate or severe.      Following an initial screening visit, subjects fulfilling the study inclusion and exclusion     criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory     and ECG assessments and to confirm eligibility for inclusion into the study. This screening     phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the     screening period, eligible subjects will be randomized at the baseline visit to receive     either orvepitant 60mg/day or placebo (1:1 ratio). Those subjects randomized to receive     placebo will receive study medication identical in appearance to that received by subjects     assigned to receive orvepitant.      Efficacy will be assessed using the Clinician Administered PTSD Scale (CAPS) as the primary     efficacy measure. Key secondary efficacy endpoints will be based on the Davidson Trauma Scale     (DTS), the Short PTSD Rating Interview (SPRINT), the Clinical Global Impression- Global     Improvement and Severity of Illness Scales (CGI-I and CGI-S, respectively), the Hamilton     Depression Rating Scale (HAM-D), the Cognitive and Physical Functioning Questionnaire (CPFQ)     and the Pittsburgh Sleep Quality Index (PSQI).      Safety will be assessed by monitoring for adverse events (side effects) and through periodic     laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart     rate, temperature) and heart function measurements (electrocardiograms, or ECGs).   "
256801|NCT00980460|"     This phase III trial studies the side effects and how well risk-based therapy works in     treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs     (cancer fighting medicines), and when necessary, liver transplant, are the main current     treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best     treatment. Treating patients according to the risk group they are in may help get rid of the     cancer, keep it from coming back, and decrease the side effects of chemotherapy.   "
256802|NCT00942331|"     This randomized phase III trial studies gemcitabine hydrochloride, cisplatin, and bevacizumab     to see how well they work compared with gemcitabine hydrochloride and cisplatin in treating     patients with urinary tract cancer that has spread to other places in the body. Drugs used in     chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with     the ability of tumor cells to grow and spread. It is not yet known whether gemcitabine     hydrochloride and cisplatin are more effective when given with or without bevacizumab in     treating patients with urinary tract cancer.   "
256803|NCT00922922|"     The purpose of this study is to compare the duration and direct cost of pediatric primary     care visits consisting of medical concerns only, behavioral concerns only, and medical and     behavioral concerns.   "
256807|NCT00769379|"     This randomized phase III trial studies radiation therapy to see how well it works with or     without trastuzumab in treating women with ductal carcinoma in situ who have undergone     lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy     x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective     with or without trastuzumab in treating ductal carcinoma in situ.   "
256808|NCT00708045|"     Patients must have had their breast cancer treated at the Huntsman Cancer Institute to be     eligible for this trial.      OBJECTIVES:      To use quantitative FDG-PET, functional MRI (fMRI) and co-registered anatomic MRI imaging to     better understand the cognitive disorder known as chemobrain which effects up to 16 -50% of     individuals receiving long-term adjuvant chemotherapy [Tannock 2004, Matsuda 2005]. The study     is exploratory to obtain proof of feasibility pilot data to support an eventual submission to     the NIH.      Neuropsychological Testing A battery of testing will be used to assess the subjective     complaints of cognitive impairment in the symptomatic patient cohort. Similarly the same     battery of tests will be used to assure that the non-symptomatic patient control group and     the age-matched normal controls do not exhibit any cognitive impairment. The following set of     clinical tests will be performed to assess the degree of cognitive impairment in all     subjects.   "
256809|NCT00629642|"     A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder     symptoms due to spinal cord injury or multiple sclerosis   "
256810|NCT00619710|"     The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and     imipenem in hospitalised subjects with complicated skin and skin structure infections.   "
256811|NCT00588770|"     This randomized phase III trial studies chemotherapy to see how well it works with or without     bevacizumab in treating patients with head and neck squamous cell carcinoma that has come     back (recurrent) or that has spread to other parts of the body (metastatic). Drugs used in     chemotherapy, such as docetaxel, cisplatin, carboplatin, and fluorouracil, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may     interfere with the ability of tumor cells to grow and spread. Bevacizumab may also make tumor     cells more sensitive to chemotherapy and stop the growth of head and neck cancer by blocking     blood flow to the tumor. It is not yet known whether combination chemotherapy is more     effective when given with or without bevacizumab in treating patients with head and neck     squamous cell carcinoma.   "
256812|NCT00494169|"     The aims of this study are: 1) to identify genes that play a role in human pubertal     development and reproduction, 2) to characterize the phenotypic spectrum of patients with     these gene defects, and 3) to discern the mode of inheritance for disorders caused by these     gene defects. We are specifically interested in genes that cause Kallmann syndrome,     idiopathic hypogonadotropic hypogonadism (IHH), precocious (early) puberty, and delayed     puberty. Individuals do not have to travel to Boston to participate in this study.   "
256813|NCT00493961|"     Men with Idiopathic Hypogonadotropic Hypogonadism (IHH) lack a hormone called gonadotropin     releasing hormone (GnRH). This hormone is important for starting puberty, maintaining     testosterone levels, and fertility. The purpose of this study is to research the effects of     treating IHH men with GnRH for 7 days.   "
256814|NCT00475280|"     This study aims at considering clinical heterogeneity of patients based on a geriatric     assessment without taking into account the real age of the subject. This will allow     physicians to adapt therapy according to three different groups of patients: frail, fit and     intermediate and to evaluate the efficacy and feasibility of a therapy adapted to the     different categories of patients.   "
256815|NCT00471978|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer. It may also help the study of cancer in the future.      PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients     with lung cancer.   "
256816|NCT00392756|"     The purpose of the study is to examine how Kallmann syndrome (KS) and idiopathic     hypogonadotropic hypogonadism (IHH) affect reproductive hormones. These disorders are caused     by a defect in Gonadotropin Releasing Hormone (GnRH) secretion. GnRH is a hormone released by     a small gland in the brain called the hypothalamus. When GnRH is released, it signals another     gland in the brain, the pituitary, to secrete the reproductive hormones that influence     testosterone levels and sperm production.      This study involves a detailed evaluation and 8-24 hours stay at the hospital.      In this study, males ages 16 and older with IHH have a detailed evaluation which involves an     overnight study at the hospital. Some men (18 years and older) may continue on to receive     treatment with pulsatile GnRH. This treatment replaces the hormone which is absent in IHH and     results in normalized testosterone and typically is effective in developing fertility.   "
256817|NCT00356265|"     The purpose of this study is to learn more about why most patients with early stages of     kidney disease have high blood pressure.      We know the body produces natural substances that cause blood vessels to open wider to carry     more blood when needed. An example is during exercise. Other natural substances cause blood     vessels to get smaller and slow down blood flow when needed. An example is when people are     cold. The balance between these substances is important. People with kidney disease and high     blood pressure do not have the normal balance of these substances.      This study will include 3 groups of people, people with normal blood pressure, people with     high blood pressure and people with kidney disease.        -  Subjects will have a screening physical examination, including an ECG and laboratory          tests        -  Subjects with high blood pressure may not take their regular blood pressure medication          for 3 weeks prior to the inpatient GCRC study        -  Subjects will be given intra-arterial medications that will cause changes in the blood          vessels during the in-patient study.      The study will then compare the responses of the three groups. A GFR test will be done to     confirm the renal function of the group with chronic kidney disease.      These studies will provide insight into the mechanisms of the pathogenesis of enhanced α1     vasoreactivity in subjects with progressive renal disease. This will lay the groundwork for     new strategies in the treatment and prevention of vascular disease among the rapidly growing     group of individuals with CKD.   "
256818|NCT00340132|"     The Pima Indians of Arizona have the highest prevalence and incidence of type 2 diabetes of     any population in the world. Prospective analyses in this population have identified insulin     resistance and a defect in early insulin secretion as risk factors for the development of the     disease. A recent longitudinal analysis which tracked the development of diabetes in 17 Pima     Indians demonstrated that both insulin action and early insulin secretion deteriorate as     individuals progress from normal to impaired glucose tolerance and then to diabetes. These     results suggest that both inherent (apparent in normal glucose tolerant subjects who progress     to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress     from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action     and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and     environmental determinants of diabetes we plan to study Pima Indian families to determine:     (1) if there are genes that segregate with metabolic risk factors for diabetes which might     therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and     environmental determinants of insulin resistance and impaired insulin secretion.      Volunteers for this study will be admitted to the clinical research ward where they will     undergo several tests to determine body composition, oral and intravenous glucose tolerance     and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle     tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and     insulin action in these tissues. A transformed lymphocyte cell line will be established for     each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2     diabetes and insulin resistance will be sought by typing each individual at positional and     functional candidate loci in the hopes of finding an association between these loci and     obesity, insulin secretion, insulin resistance and/or type 2 diabetes.   "
256819|NCT00318994|"     To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis     requiring surgery between 30 to 60 minutes after a bolus of 1 g IV meropenem given during the     induction period of anesthesia.   "
256820|NCT00318552|"     This study will directly compare meropenem with standard first line antibiotic therapies in     subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while     resident in an ICU.   "
256821|NCT00310180|"     This randomized phase III trial studies the best individual therapy for women who have     node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype     DX), and whether hormone therapy alone or hormone therapy together with combination     chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen     can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by     blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the     body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving hormone therapy together with more than one chemotherapy drug (combination     chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the     benefit of adding chemotherapy to hormone therapy for women with node-negative,     estrogen-receptor positive breast cancer is small. New tests may provide information about     which patients are more likely to benefit from chemotherapy.   "
256822|NCT00175916|"     This trial, evaluating the long-term safety and tolerability of brivaracetam, will give     subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity     to continue the treatment. The study will also evaluate the maintenance of efficacy over time     of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures     (PGS).   "
256823|NCT00121251|"     This phase I/II trial is studying the side effects and best dose of sorafenib, gemcitabine,     and capecitabine and to see how well they work in treating patients with unresectable and/or     metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     sorafenib together with gemcitabine and capecitabine may kill more tumor cells.   "
256824|NCT00118274|"     RATIONALE: Vaccines made from peptides may help the body build an effective immune response     to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop     tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery     may cause a stronger immune response to kill any remaining tumor cells. It may also prevent     or delay the recurrence of melanoma.      PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy     when given with or without cyclophosphamide and to see how well they work in treating     patients who have undergone surgery for stage II, stage III, or stage IV melanoma.   "
256825|NCT00061438|"     This is a research study in patients having a condition known as necrotizing pancreatitis.     This is inflammation of the pancreas (an intestinal organ which assists with digestion) that     has resulted in the damage and death of some pancreatic tissue. This damaged pancreatic     tissue may develop a bacterial infection, which can cause further -sometimes very serious-     health problems.      It may be possible to prevent or delay infection by giving 'prophylactic' antibiotics (that     is - to provide protection before any infection starts). However, it is not certain that this     antibiotic therapy will be successful.      This study is being carried out to see whether the antibiotic 'Meropenem' (which is also     known as MERREM I.V.) provides protection from developing a pancreatic infection. This will     be done by comparing the progress of patients who receive meropenem with those who receive a     non-active placebo solution (a solution that does not contain any active medication).      Meropenem or placebo would be given in addition to the standard treatment received for     pancreatitis.      It is not known if meropenem will help prevent infections associated with necrotizing     pancreatitis.      Approximately 240 patients will take part in this study.      Study participation will be carried out for up to 6 weeks, and patients will receive the     study treatment up to a maximum of 21 days.   "
256826|NCT00059033|"     This study will conduct tests in patients with primary chronic autonomic failure (CAF) to     learn more about these disorders, which include pure autonomic failure, multiple system     atrophy, Parkinson's disease with autonomic failure, and autoimmune autonomic neuropathy.      Healthy volunteers and patients with primary CAF 18 years of age or older may be eligible for     this study. Participants undergo some of the following tests:        -  Blood studies, including arterial catheter insertion to measure blood pressure and          collect arterial blood samples, blood flow studies using sensors applied to the skin and          a pressure cuff around a limb, and blood draw for genetic studies.        -  Bladder motility: Ultrasound test of bladder function.        -  Electrocardiogram and heart ultrasound.        -  Responses to changes in temperature: Warm water and then room temperature water are          passed through watertight pads applied to the back and front of the body and body          temperatures are measured.        -  Gastrointestinal motility: Bowel sounds are recorded using a microphone placed on the          abdomen.        -  Lower body negative pressure: The lower body is placed into an airtight barrel-like          chamber. Some air is sucked out of the barrel, causing blood to pool in the legs, as          occurs during standing.        -  Lumbar puncture: A needle is inserted in the space between the bones in the lower back          to collect a small sample of cerebrospinal fluid.        -  Microdialysis to measures levels of chemicals in the body fluid of certain tissues. A          solution is passed through a thin tube inserted into the skin. Chemicals in the body          tissues enter the solution. The solution is collected and the chemical levels are          measured.        -  PET scanning: A nuclear medicine test to produce images of body organs. For patients          with urinary problems, a catheter is inserted into the bladder before starting the scan.        -  Pupillometry: The pupil of the eye is measured using a special camera in a          light-controlled room.        -  QSART. A small amount of a brain chemical is applied to the skin with a tiny amount of          electricity, and the sweat in a nearby patch of skin is measured.        -  Measurement of saliva production, using a cotton-like material placed between the teeth          and gums to absorb saliva.        -  Skin electrical conduction test, using sensors on the skin to measure sweat production.        -  Skin and core temperature measurements using sensors on the skin and in the ear canal.        -  Speech and swallowing assessment for patients with speech and swallowing difficulties.        -  Stress echocardiogram: A catheter is placed in the subject's arm for sampling blood or          giving a drug while the subject exercises. During the test, blood pressure, pulse rate,          and EKG are continuously monitored.   "
256827|NCT00050401|"     The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.),     along with another drug called an aminoglycoside (a different type of antibiotic) is     effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa,     Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult     to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory     support. The study hopes to show that by increasing the amount of meropenem administered and     increasing the duration of infusion (release of the drug into the bloodstream), levels of the     drug will stay at target levels in the bloodstream and decrease the ability of difficult to     treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem)     or other antibiotics.   "
256828|NCT00004847|"     The goal of this study is to develop better methods of diagnosis, localization, and treatment     for pheochromocytomas. These tumors, which usually arise from the adrenal glands, are often     difficult to detect with current methods. Pheochromocytomas release chemicals called     catecholamines, causing high blood pressure. Undetected, the tumors can lead to severe     medical consequences, including stroke, heart attack and sudden death, in situations that     would normally pose little or no risk, such as surgery, general anesthesia or childbirth.      Patients with pheochromocytoma may be eligible for this study. Candidates will be screened     with a medical history and physical examination, electrocardiogram, and blood and urine     tests. Study participants will undergo blood, urine, and imaging tests, described below, to     detect pheochromocytoma. If a tumor is found, the patient will be offered surgery. If surgery     is not feasible (for example, if there are multiple tumors that cannot be removed),     evaluations will continue in follow-up visits. If the tumor cannot be found, the patient will     be offered medical treatment and efforts to detect the tumor will continue. Main diagnostic     and research tests may include the following:        1. Blood tests - mainly measurements of plasma or urine catecholamines and metanephrines as          well as methoxytyramine. If necessary the clonidine suppression test can be carried out.        2. Standard imaging tests - Non-investigational imaging tests include computed tomography          (CT), magnetic resonance imaging (MRI), sonography, and 123I-MIBG scintigraphy and FDG          (positron emission tomography) PET/CT. These scans may be done before and/or after          surgical removal of pheochromocytoma.        3. Research PET scanning is done using an injection of radioactive compounds. Patients may          undergo 18F-FDOPA, 18F-DA, as well as 68Ga-DOTATATE PET/CT . Each scan takes up to about          2 hours.        4. Genetic testing - A small blood sample is collected for DNA analysis and other analyses.   "
